###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 edoxa