The scores on the variables of Health Belief Model , the using rate of salt-restriction-spoon , the actual salt intake , and 24HUNa .


Covariance analyses , Chi-square tests , Student 's t tests , and repeated measures analyses of variance .


After 6 months of intervention , the intervention group felt significantly less objective barriers , and got access to significantly more cues to action as compared to the control group .


The using rate and the correctly using rate of salt-restriction-spoon were significantly higher in the intervention group .


The daily salt intake decreased by 1.42 g in the intervention group and by 0.28 g in the control group , and repeated measures analysis of variance showed significant change over time ( F = 7.044 , P < 0.001 ) and significant difference between groups by time ( F = 2.589 , P = 0.041 ) .


The 24HUNa decreased by 34.84 mmol in the intervention group and by 33.65 mmol in the control group , and repeated measures analysis of variance showed significant change over time ( F = 14.648 , P < 0.001 ) without significant difference between groups by time ( F = 0.222 , P = 0.870 ) .


The intervention effect was acceptable , therefore , the improved salt-restriction-spoon and corresponding health education could be considered as an alternative for salt reduction strategy in China and other countries where salt intake comes mainly from home cooking .


Revisional laparoscopic surgery after Roux-en-Y gastric bypass ( RYGB ) has been linked to substantial complications and morbidity .


To investigate the safety and effectiveness of endoscopic gastric plication with the StomaphyX device vs a sham procedure for revisional surgery in RYGB patients to reduce regained weight .


A prospective , single-center , randomized , single-blinded study from July 2009 through February 2011 , evaluating revisional surgery using StomaphyX was conducted in patients with initial weight loss after RYGB performed at least 2 years earlier .


We planned for 120 patients to be randomized 2:1 to multiple full-thickness plications within the gastric pouch and stoma using the StomaphyX device with SerosFuse fasteners or a sham endoscopic procedure and followed up for 1 year .


The primary efficacy end point was reduction in pre-RYGB excess weight by 15 % or more excess body mass index ( BMI ) ( calculated as weight in kilograms divided by height in meters squared ) loss and BMI less than 35 at 12 months after the procedure .


Adverse events were recorded .


Enrollment was closed prematurely because preliminary results indicated failure to achieve the primary efficacy end point in at least 50 % of StomaphyX-treated patients .


One-year follow-up was completed by 45 patients treated with StomaphyX and 29 patients in the sham treatment group .


Primary efficacy outcome was achieved by 22.2 % ( 10 ) with StomaphyX vs 3.4 % ( 1 ) with the sham procedure ( P < .01 ) .


Patients undergoing StomaphyX treatment experienced significantly greater reduction in weight and BMI at 3 , 6 , and 12 months ( P. 05 ) .


There was one causally related adverse event with StomaphyX , that required laparoscopic exploration and repair .


StomaphyX treatment failed to achieve the primary efficacy target and resulted in early termination of the study .


clinicaltrials.gov Identifier : NCT00939055 .


Carpal tunnel syndrome is traditionally treated with open release through a long palmar incision , which leaves some patients with pillar pain and scar tenderness .


The Knifelight ( Stryker , Kalamazoo , MI ) is an exciting new instrument that allows minimally invasive release of the transcarpal ligament without subjecting the patient to the traditional problematic open palmar incision .


However , no long-term data has been published in the literature so far .


A modified QuickDASH score questionnaire was used to assess long-term results and patient satisfaction 10 years following our department 's original randomized control trial comparing open carpal tunnel release ( 43 patients ) to carpal tunnel release using the Knifelight method ( 39 patients ) .


The mean modified QuickDASH score was 33.71 ( SD 23.27 ) for the open group and 13.22 ( SD 13.62 ) for the Knifelight group ( P-value = 0.0024 ) .


Patients from the open group complained of pillar pain ( 30 % ) , scar tenderness ( 25 % ) and recurrence of carpal tunnel symptoms ( 18 % ) .


Three patients had symptoms so severe that they could not perform their jobs .


In the Knifelight group there were no reports of any pain , recurrence or scar-related problems and a high level of general satisfaction was observed with this group of patients .


Our study results show that the minimally invasive Knifelight carpal tunnel release was associated with better clinical outcomes , less complications and overall better quality of life when compared to the conventional open carpal tunnel release .


Calcitriol is used to treat secondary hyperparathyroidism in patients with CKD .


Paricalcitol is less calcemic and phosphatemic in preclinical studies and in some trials in dialysis patients , but head-to-head comparisons in nondialysis patients are lacking .


A large meta-analysis of trials concluded that these agents did not consistently reduce parathyroid hormone ( PTH ) and increased the risk of hypercalcemia and hyperphosphatemia .


Therefore , the objective of this multicenter trial was to compare the rate of hypercalcemia between calcitriol and paricalcitol , while suppressing PTH 40 % -60 % .


Patients with stages 3-4 CKD ( n = 110 ) with a PTH level > 120 pg/ml were recruited and randomized to 0.25 g/d of calcitriol or 1 g/d of paricalcitol between April 2009 and July 2011 .


Subsequent dose adjustments were by protocol to achieve 40 % -60 % PTH suppression below baseline .


The primary endpoint was the rate of confirmed hypercalcemia of > 10.5 mg/dl between groups .


Forty-five patients in each group completed the 24 weeks of treatment .


Both agents suppressed PTH effectively ( -52 % with paricalcitol and -46 % with calcitriol ; P = 0.17 ) , although the paricalcitol group reached a 40 % reduction in PTH sooner at a median 8 weeks ( interquartile range [ IQR ] , 4 , 12 ) versus 12 weeks ( IQR , 8 , 18 ; P = 0.02 ) and had a lower pill burden of 240 ( IQR , 180 , 298 ) versus 292 ( IQR , 231 , 405 ; P = 0.01 ) .


Confirmed hypercalcemia was very low in both groups ( three with paricalcitol and one with calcitriol ) and was not significantly different ( P = 0.36 ) .


Both groups had small increases in calcium and phosphorus levels ( 0.3-0 .4 mg/dl in each electrolyte ) and significant decreases in alkaline phosphatase , a marker of high bone turnover , with no significant differences between groups .


These results show that both calcitriol and paricalcitol achieved sustained PTH and alkaline phosphatase suppression in stages 3-4 CKD , with small effects on serum calcium and phosphorus and a low incidence of hypercalcemia .


Both testosterone therapy and chronic treatment with phosphodiesterase type 5 inhibitors ( PDE5Is ) have positive effects on the histology of penile corpora and erectile function .


However , few clinical studies have evaluated the efficacy of combination therapy with both testosterone replacement and chronic PDE5Is .


This study was designed to evaluate the efficacy and safety of combination treatment with long-acting injectable testosterone undecanoate ( TU ) and a once-daily tadalafil 5mg for erectile dysfunction with testosterone deficiency syndrome .


Sixty patients were consecutively enrolled and followed for 36 weeks .


Thirty patients were randomly assigned to group I and received 1,000 mg of parenteral TU on day 1 , followed by additional injections at weeks 6 and 18 with on-demand tadalafil 10-20mg during the 30 weeks of treatment .


The remaining 30 patients received the same dose and schedule of TU as group I , and were prescribed once-daily tadalafil 5mg during 30 weeks .


Serological tests were performed , and the International Index of Erectile Function ( IIEF ) , Aging Males ' Symptoms ( AMS ) questionnaires , and Global Assessment Question ( GAQ ) were administered to the patients .


Total IIEF and AMS scores were significantly improved during the 30 weeks of treatment in both groups .


When IIEF scores were compared between the two groups , group II showed better symptom scores than group I at weeks 6 and 30 .


A similar pattern was observed when comparing AMS scores between the groups .


At week 36 , changes in IIEF and AMS scores that indicated worsened symptoms compared with week 30 were observed in both groups ; group II showed better symptom scores than group I. On the GAQ , the ratio of patients reporting improvement in erectile function was significantly higher in group II than group I.


The combination of long-acting injectable TU and once-daily tadalafil 5mg produced a significant improvement in erectile function .


Moreover , the improvement in erectile function was well maintained , even after the cessation of treatment .


To determine the effects of pretreatment with either promethazine or dexamethasone on mivacurium-induced histamine release in children .


Eighty ASA I-II children ( 4-10years of age ) scheduled for tonsillectomy and/or adenoidectomy were randomly divided into 4 groups ( n = 20 per group ) designated as either the rocuronium , mivacurium , dexamethasone ( DXM ) , or promethazine group .


Children in the DXM and promethazine groups were treated separately with intramuscular DXM 0.2 mgkg ( -1 ) or promethazine 0.5 mgkg ( -1 ) injections 60min before operation .


Radial artery blood samples were collected to quantify plasma histamine concentrations 1min before and 1 , 3 , and 5min after administration of the relaxant .


Mean arterial pressure ( MAP ) , heart rate ( HR ) , and skin flushing were recorded at the same time .


No significant decreases in plasma histamine concentrations were observed between groups ; however , more stable MAP and HR and less skin flushing were observed in DXM group participants compared with individuals in the mivacurium group ( P < 0.05 ) .


By contrast , children in the promethazine group had significantly decreased plasma histamine concentrations and stable MAP and HR ( without a significant increase in HR ) compared with patients in mivacurium group .


In addition , skin flushing was significantly decreased compared with that observed in the rocuronium group ( P < 0.05 ) .


Pretreatment with promethazine significantly decreased mivacurium-induced histamine release in children and provided stable hemodynamics during administration of anesthesia .


Improved health outcomes can result in economic savings for hospitals and payers .


While effectiveness of topical hemostatic agents in cardiac surgery has been demonstrated , evaluations of their economic benefit are limited .


This study quantifies the cost consequences to hospitals , based on clinical outcomes , from using a flowable hemostatic matrix vs non-flowable topical hemostatic agents in cardiac surgery .


Applying clinical outcomes from a prospective randomized clinical trial , a cost consequence framework was utilized to model the economic impact of comparator groups .


From that study , clinical outcomes were obtained and analyzed for a flowable hemostatic matrix ( FLOSEAL , Baxter Healthcare Corporation ) vs non-flowable topical hemostats ( SURGICEL Nu-Knit , Ethicon-Johnson & Johnson ; GELFOAM , Pfizer ) .


Costing analyses focused on the following outcomes : complications , blood transfusions , surgical revisions , and operating room ( OR ) time .


Cardiac surgery costs were analyzed and expressed in 2012 US dollars based on available literature searches and US data .


Comparator group variability in cost consequences ( i.e. , cost savings ) was calculated based on annualized impact and scenario testing .


RESULTS suggest that if a flowable hemostatic matrix ( rather than a non-flowable hemostat ) was utilized exclusively in 600 mixed cardiac surgeries annually , a hospital could improve patient outcomes by a reduction of 33 major complications , 76 minor complications , 54 surgical revisions , 194 transfusions , and 242 h of OR time .


These outcomes correspond to a net annualized cost consequence savings of $ 5.38 million , with complication avoidance as the largest contributor .


This cost consequence framework and supportive modeling was used to evaluate the hospital economic impact of outcomes resulting from the usage of various hemostatic agents .


These analyses support that cost savings can be achieved from routine use of a flowable hemostatic matrix , rather than a non-flowable topical hemostat , in cardiac surgery .


This report presents data from one of the first trials of apomorphine rescue treatment for advanced Parkinson 's disease ( PD ) conducted in Japan .


This 3 month trial aimed to evaluate the sustainability of efficacy of intermittent apomorphine rescue treatment .


A phase III , double-blind , placebo-controlled trial was conducted in PD patients ( n = 31 ) with motor fluctuations in spite of individually titrated treatment with levodopa and other anti PD .


Intermittent treatment was titrated to the maintenance dose with a subsequent unblind 12-week outpatient phase .


At the week-12 visit , response to apomorphine or placebo was assessed as primary efficacy endpoint using the Unified Parkinson 's Disease Rating Scale ( UPDRS ) part III ( Motor Examination ) under double-blind crossover conditions .


In the crossover phase ( n = 28 ) , least squares mean changes in the UPDRS part III score from pre-dose were -24.5 points with apomorphine and -2.3 points with placebo , showing that apomorphine , compared with placebo , provided a significantly greater improvement in the UPDRS part III score change ( difference between treatments : -22.1 [ 95 % confidence interval , -27.8 , -16.4 ] ; P < 0.001 ) .


The most frequently reported adverse events during the study were increased eosinophil count ( 8 patients ) , nausea ( 7 ) , somnolence ( 6 ) , dyskinesia ( 5 ) , yawning ( 5 ) , and decreased blood pressure ( 3 ) .


Our results indicate that a 3-month use of intermittent apomorphine is an effective rescue therapy for `` off '' episodes in advanced PD patients .


To assess face , content and construct validity , and feasibility and acceptability of the GreenLight Simulator as a training tool for photoselective vaporisation of the prostate ( PVP ) , and to establish learning curves and develop an evidence-based training curriculum .


This prospective , observational and comparative study , recruited novice ( 25 participants ) , intermediate ( 14 ) and expert-level urologists ( seven ) from the UK and Europe at the 28th European Association of Urological Surgeons Annual Meeting 2013 .


A group of novices ( 12 participants ) performed 10 sessions of subtask training modules followed by a long operative case , whereas a second group ( 13 ) performed five sessions of a given case module .


Intermediate and expert groups performed all training modules once , followed by one operative case .


The outcome measures for learning curves and construct validity were time to task , coagulation time , vaporisation time , average sweep speed , average laser distance , blood loss , operative errors , and instrument cost .


Face and content validity , feasibility and acceptability were addressed through a quantitative survey .


Construct validity was demonstrated in two of five training modules ( P = 0.038 ; P = 0.018 ) and in a considerable number of case metrics ( P = 0.034 ) .


Learning curves were seen in all five training modules ( P < 0.001 ) and significant reduction in case operative time ( P < 0.001 ) and error ( P = 0.017 ) were seen .


An evidence-based training curriculum , to help trainees acquire transferable skills , was produced using the results .


This study has shown the GreenLight Simulator to be a valid and useful training tool for PVP .


It is hoped that by using the training curriculum for the GreenLight Simulator , novice trainees can acquire skills and knowledge to a predetermined level of proficiency .


Incidence of sexually transmitted infections ( STIs ) among young people in the United Kingdom is increasing .


The Internet can be a suitable medium for delivery of sexual health information and sexual health promotion , given its high usage among young people , its potential for creating a sense of anonymity , and ease of access .


Online randomized controlled trials ( RCTs ) are increasingly being used to evaluate online interventions , but while there are many advantages to online methodologies , they can be associated with a number of problems , including poor engagement with online interventions , poor trial retention , and concerns about the validity of data collected through self-report online .


We conducted an online feasibility trial that tested the effects of the Sexunzipped website for sexual health compared to an information-only website .


This study reports on a qualitative evaluation of the trial procedures , describing participants ' experiences and views of the Sexunzipped online trial including methods of recruitment , incentives , methods of contact , and sexual health outcome measurement .


Our goal was to determine participants ' views of the acceptability and validity of the online trial methodology used in the pilot RCT of the Sexunzipped intervention .


We used three qualitative data sources to assess the acceptability and validity of the online pilot RCT methodology : ( 1 ) individual interviews with 22 participants from the pilot RCT , ( 2 ) 133 emails received by the trial coordinator from trial participants , and ( 3 ) 217 free-text comments from the baseline and follow-up questionnaires .


Interviews were audio-recorded and transcribed verbatim .


An iterative , thematic analysis of all three data sources was conducted to identify common themes related to the acceptability and feasibility of the online trial methodology .


Interview participants found the trial design , including online recruitment via Facebook , online registration , email communication with the researchers , and online completion of sexual health questionnaires to be highly acceptable and preferable to traditional methods .


Incentives might assist in recruiting those who would not otherwise participate .


Participants generally enjoyed taking part in sexual health research online and found the questionnaire itself thought-provoking .


Completing the sexual health questionnaires online encouraged honesty in responding that might not be achieved with other methods .


The majority of interview participants also thought that receiving and returning a urine sample for chlamydia testing via post was acceptable .


These findings provide strong support for the use of online research methods for sexual health research , emphasizing the importance of careful planning and execution of all trial procedures including recruitment , respondent validation , trial related communication , and methods to maximize follow-up .


Our findings suggest that sexual health outcome measurement might encourage reflection on current behavior , sometimes leading to behavior change .


International Standard Randomized Controlled Trial Number ( ISRCTN ) : 55651027 ; http://www.controlled-trials.com/isrctn/pf/55651027 ( Archived by WebCite at http://www.webcitation.org/6LbkxdPKf ) .


In addition to lowering hemoglobin A1C , colesevelam has been shown to improve the atherogenic lipoprotein profile of subjects with type 2 diabetes mellitus ( T2DM ) when used in combination with metformin and/or sulfonylureas .


A recent study evaluated the effects of colesevelam as antidiabetes monotherapy in adults with T2DM who had inadequate glycemic control ( hemoglobin A1C 7.5 to 9.5 % ) with diet and exercise alone ; we report here the effects on lipoprotein particle subclasses .


Subjects were randomized to receive oral colesevelam 3.75 g/day ( n = 176 ) or placebo ( n = 181 ) for 24weeks .


Changes in lipoprotein particle subclasses were determined by nuclear magnetic resonance spectroscopy .


At Week 24 with last observation carried forward , colesevelam produced a reduction in total low-density lipoprotein ( LDL ) particle concentration ( baseline : 1,611 nmol/L ; least-squares [ LS ] mean treatment difference : -143 nmol/L , p < 0.0001 ) versus placebo ; reductions were also seen in large , small , and very small LDL particle concentrations ( all p < 0.05 ) .


There was also a reduction in total very low-density lipoprotein ( VLDL ) and chylomicron particle concentration ( baseline : 88nmol/L ; LS mean treatment difference : -1 nmol/L , p = 0.82 ) that resulted from a lowering in small VLDL particle concentration ( baseline : 45nmol/L ; LS mean treatment difference : -5 nmol/L , p = 0.03 ) .


In addition , with colesevelam there was an increase in total high-density lipoprotein ( HDL ) particle concentration versus placebo ( baseline : 31mol/L ; LS mean treatment difference : +0.6 mol/L , p = 0.20 ) , due to increases in the large ( baseline : 5mol/L ; LS mean treatment difference : +0.5 mol/L , p = 0.007 ) and medium ( baseline : 3mol/L ; LS mean treatment difference : +0.8 mol/L , p = 0.02 ) HDL subclasses .


Colesevelam monotherapy in subjects with T2DM resulted in generally favorable changes in certain lipoprotein subclass profiles compared with placebo .


Amino-terminal B-type natriuretic peptide ( NT-proBNP ) may detect early cardiac dysfunction in adults with tetralogy of Fallot ( ToF ) late after corrective surgery .


We aimed to determine the value of NT-proBNP in adults with ToF and establish its relationship with echocardiography and exercise capacity .


NT-proBNP measurement , electrocardiography and detailed 2D-echocardiography were performed on the same day in 177 consecutive adults with ToF ( mean age 34.6 11.8 years , 58 % male , 89 % NYHA I , 29.3 8.5 years after surgical correction ) .


Thirty-eight percent of the patients also underwent a cardiopulmonary-exercise test .


Median NT-proBNP was 16 [ IQR 6.7-33 .6 ] pmol/L , and was elevated in 55 % .


NT-proBNP correlated with right ventricular ( RV ) dilatation ( r = 0.271 , p < 0.001 ) and RV systolic dysfunction ( r = -0.195 , p = 0.022 ) , but more strongly with LV systolic dysfunction ( r = -0.367 , p < 0.001 ) , which was present in 69 patients ( 39 % ) .


Moderate or severe pulmonary regurgitation was not associated with higher NT-proBNP .


Tricuspid and pulmonary regurgitation peak velocities correlated with NT-proBNP ( r = 0.305 , p < 0.001 and r = 0.186 , p = 0.045 , respectively ) .


LV twist was measured with speckle-tracking echocardiography in 71 patients .


An abnormal LV twist ( 20 patients , 28 % ) was associated with elevated NT-proBNP ( p = 0.030 ) .


No relationship between NT-proBNP and exercise capacity was found .


NT-proBNP levels are elevated in more than 50 % of adults with corrected ToF , while they are in stable clinical condition .


Higher NT-proBNP is most strongly associated with elevated pulmonary pressures , and with LV dysfunction rather than RV dysfunction .


NT-proBNP has the potential to become routine examination in patients with ToF to monitor ventricular function and may be used for timely detection of clinical deterioration .


Previous research has documented the feasibility of screening in emergency departments for adolescent suicide risk .


This randomized trial examined the effectiveness of Teen Options for Change ( TOC ) , an intervention for adolescents seeking general medical emergency services who screen positive for suicide risk .


Participants were 49 youths , ages 14 to 19 , seeking services for nonpsychiatric emergencies .


They screened positive for suicide risk because of recent suicidal ideation , suicide attempt , or depression plus substance abuse .


Youths were randomly assigned to the TOC intervention or to enhanced treatment as usual .


Depression , hopelessness , and suicidal ideation were assessed at baseline and two months later .


Adolescents assigned to TOC showed greater reductions in depression than adolescents assigned to the comparison group ( Cohen 's d = 1.07 , a large effect size ) .


Hopelessness , suicidal ideation , and substance abuse outcomes trended positively ( nonsignificantly ) , with small to moderate effect sizes .


TOC may be a promising , brief intervention for adolescents seeking emergency services and at risk of suicide .


This study aimed to investigate whether targeted retinal photocoagulation ( TRP ) for nonperfused areas ( NPAs ) could have a preventive effect on the recurrence of diabetic macular edema ( DME ) after intravitreal injection of bevacizumab ( IVB ) .


Eyes in the IVB group received 1.25 mg IVB , and eyes in the IVB+TRP group received 1.25 mg IVB combined with TRP of NPAs .


Two weeks before IVB administration , grid/focal photocoagulation ( PC ) had been performed in both groups .


After IVB treatment , the best corrected visual acuity ( BCVA ) and central retinal thickness ( CRT ) , determined by optical coherence tomography , were measured every month for 6 months .


Fifty-two patients with DME were enrolled and randomized to an IVB group ( n = 26 ) and an IVB+TRP group ( n = 26 ) .


After IVB , the CRT decreased temporally , and the CRT significantly increased at 2 months and thereafter in the IVB group but did not increase significantly in the IVB+TRP group .


Maximum increase in CRT after IVB was significantly correlated with the width of NPAs in the IVB group ( P = 0.0368 ) , but not in the IVB+TRP group .


Best corrected visual acuity in the IVB+TRP group was significantly better than that in the IVB group 5 and 6 months after treatment ( P < 0.05 ) .


Targeted retinal photocoagulation for NPAs was effective to maintain the reduced CRT after grid/focal PC and IVB for patients with DME .


These results suggest that retinal ischemia is associated with the pathogenesis of recurrence of DME after IVB .


( www.umin.ac.jp/ctr number , UMIN000007566 . )


Smokers attend preferentially to cigarettes and other smoking-related cues in the environment , in what is known as an attentional bias .


There is evidence that attentional bias may contribute to craving and failure to stop smoking .


Attentional retraining procedures have been used in laboratory studies to train smokers to reduce attentional bias , although these procedures have not been applied in smoking cessation programmes .


This trial will examine the efficacy of multiple sessions of attentional retraining on attentional bias , craving , and abstinence in smokers attempting cessation .


This is a double-blind randomised controlled trial .


Adult smokers attending a 7-session weekly stop smoking clinic will be randomised to either a modified visual probe task with attentional retraining or placebo training .


Training will start 1 week prior to quit day and be given weekly for 5 sessions .


Both groups will receive 21 mg transdermal nicotine patches for 8-12 weeks and withdrawal-orientated behavioural support for 7 sessions .


Primary outcome measures are the change in attentional bias reaction time and urge to smoke on the Mood and Physical Symptoms Scale at 4 weeks post-quit .


Secondary outcome measures include differences in withdrawal , time to first lapse and prolonged abstinence at 4 weeks post-quit , which will be biochemically validated at each clinic visit .


Follow-up will take place at 8 weeks , 3 months and 6 months post-quit .


This is the first randomised controlled trial of attentional retraining in smokers attempting cessation .


This trial could provide proof of principle for a treatment aimed at a fundamental cause of addiction .


Current Controlled Trials : ISRCTN54375405 .


Laparoscopic surgery might be beneficial for the patient , but it imposes increased physical and mental strain on the surgeon .


Robot-assisted laparoscopic surgery addresses some of the laparoscopic drawbacks and may potentially reduce mental strain .


This could reduce the risk of surgeon 's fatigue , mishaps and strain-induced illnesses , which may eventually improve the safety of laparoscopic surgical procedures .


To test this hypothesis , a randomized study was performed , comparing both heart rate and heart rate variability ( HRV ) of the surgeon as a measure of total and mental strain , respectively , during conventional and robot-assisted laparoscopic cholecystectomy .


Both heart rate and HRV ( the low-frequency band/high-frequency band ratio ) were significantly decreased when using robotic assistance .


These data suggest the use of the daVinci Surgical System leads to less physical and mental strain of the surgeon during surgery .


However , assessing mental strain by means of HRV is cumbersome since there is no clear cutoff point or scale for maximum tolerated strain levels and its related effects on surgeon 's health .


Co-trimoxazole ( fixed-dose trimethoprim-sulfamethoxazole ) prophylaxis administered before antiretroviral therapy ( ART ) reduces morbidity in children infected with the human immunodeficiency virus ( HIV ) .


We investigated whether children and adolescents receiving long-term ART in sub-Saharan Africa could discontinue co-trimoxazole .


We conducted a randomized , noninferiority trial of stopping versus continuing daily open-label co-trimoxazole in children and adolescents in Uganda and Zimbabwe .


Eligible participants were older than 3 years of age , had been receiving ART for more than 96 weeks , were using insecticide-treated bed nets ( in malaria-endemic areas ) , and had not had Pneumocystis jirovecii pneumonia .


Coprimary end points were hospitalization or death and adverse events of grade 3 or 4 .


A total of 758 participants were randomly assigned to stop or continue co-trimoxazole ( 382 and 376 participants , respectively ) , after receiving ART for a median of 2.1 years ( interquartile range , 1.8 to 2.3 ) .


The median age was 7.9 years ( interquartile range , 4.6 to 11.1 ) , and the median CD4 T-cell percentage was 33 % ( interquartile range , 26 to 39 ) .


Participants who stopped co-trimoxazole had higher rates of hospitalization or death than those who continued ( 72 participants [ 19 % ] vs. 48 [ 13 % ] ; hazard ratio , 1.64 ; 95 % confidence interval [ CI ] , 1.14 to 2.37 ; P = 0.007 ; noninferiority not shown ) .


There was no evidence of variation across ages ( P = 0.93 for interaction ) .


A total of 2 participants in the prophylaxis-stopped group ( 1 % ) died , as did 3 in the prophylaxis-continued group ( 1 % ) .


Most hospitalizations in the prophylaxis-stopped group were for malaria ( 49 events , vs. 21 in the prophylaxis-continued group ) or infections other than malaria ( 53 vs. 25 ) , particularly pneumonia , sepsis , and meningitis .


Rates of adverse events of grade 3 or 4 were similar in the two groups ( hazard ratio , 1.20 ; 95 % CI , 0.83 to 1.72 ; P = 0.33 ) , but more grade 4 adverse events occurred in the prophylaxis-stopped group ( hazard ratio , 2.04 ; 95 % CI , 0.99 to 4.22 ; P = 0.05 ) , with anemia accounting for the largest number of events ( 12 , vs. 2 with continued prophylaxis ) .


Continuing co-trimoxazole prophylaxis after 96 weeks of ART was beneficial , as compared with stopping prophylaxis , with fewer hospitalizations for both malaria and infection not related to malaria .


( Funded by the United Kingdom Medical Research Council and others ; ARROW Current Controlled Trials number , ISRCTN24791884 . )


This study seeks to determine if variation in the dopamine transporter gene ( SLC6A3/DAT1 ) moderates the dose-response effects of long-acting dexmethylphenidate ( D-MPH ) and mixed amphetamine salts ( MAS ) in children with attention-deficit/hyperactivity disorder ( ADHD ) .


Fifty-six children and adolescents ( mean age = 11.72.2 ) participated in a double-blind , two period crossover , dose-response study with a randomized placebo week in each 4 week drug period .


Each period consisted of sequential week-long exposures to three dose levels ( 10 , 20 , 25-30mg , depending upon weight ) of D-MPH or MAS .


Doses of 10-20mg of either D-MPH or MAS had little to no effect on hyperactivity-impulsivity and total ADHD symptom scores in subjects with the 9/9 genotype ; this was in contrast to the dose-response curves of subjects with either the 10/10 or 10/9 genotype .


ADHD youth with the 9/9 genotype may require higher stimulant doses to achieve adequate symptom control .


Ultrasound guidance for continuous femoral perineural catheters may be supplemented by electrical stimulation through a needle or through a stimulating catheter .


The authors tested the primary hypothesis that ultrasound guidance alone is noninferior on both postoperative pain scores and opioid requirement and superior on at least one of the two .


Second , the authors compared all interventions on insertion time and incremental cost .


Patients having knee arthroplasty with femoral nerve catheters were randomly assigned to catheter insertion guided by : ( 1 ) ultrasound alone ( n = 147 ) ; ( 2 ) ultrasound and electrical stimulation through the needle ( n = 152 ) ; or ( 3 ) ultrasound and electrical stimulation through both the needle and catheter ( n = 138 ) .


Noninferiority between any two interventions was defined for pain as not more than 0.5 points worse on a 0 to 10 verbal response scale and for opioid consumption as not more than 25 % greater than the mean .


The stimulating needle group was significantly noninferior to the stimulating catheter group ( difference [ 95 % CI ] in mean verbal response scale pain score [ stimulating needle vs. stimulating catheter ] of -0.16 [ -0.61 to 0.29 ] , P < 0.001 ; percentage difference in mean IV morphine equivalent dose of -5 % [ -25 to 21 % ] , P = 0.002 ) and to ultrasound-only group ( difference in mean verbal response scale pain score of -0.28 [ -0.72 to 0.16 ] , P < 0.001 ; percentage difference in mean IV morphine equivalent dose of -2 % [ -22 to 25 % ] , P = 0.006 ) .


In addition , the use of ultrasound alone for femoral nerve catheter insertion was faster and cheaper than the other two methods .


Ultrasound guidance alone without adding either stimulating needle or needle/catheter combination thus seems to be the best approach to femoral perineural catheters .


To investigate monthly and seasonal variations in the progression of myopia in children enrolled in the Correction of Myopia Evaluation Trial ( COMET ) .


An ethnically diverse cohort of 469 myopic 6 - to < 12 year-old children was randomized to single vision or progressive addition lenses and followed for 3 years with 98.5 % retention .


Progression of myopia was measured semiannually by noncycloplegic autorefraction ( Nidek ARK 700A ) and annually by cycloplegic autorefraction , with the former measurements used in these analyses .


The semiannual progression rate was calculated as ( change in spherical equivalent refraction between two consecutive semiannual visits/number of days between the two visits ) times 182.5 .


Months were categorized as the midpoint between two visit dates .


Seasons were classified as winter ( October through March ) or summer ( April through September ) .


The seasonal difference was tested using a linear mixed model adjusting for demographic variables ( age , sex , ethnicity ) , baseline refraction , and treatment group .


Data from 358 children ( mean [ SD ] age = 9.84 1.27 years ; mean myopia = -2.54 0.84 diopters [ D ] ) met the criteria for these analyses .


Myopia progression varied systematically by month ; it was slower in April through September than in the other months .


Mean progression in winter was -0.35 0.34 D and in summer was -0.14 0.32 D , a statistically significant difference ( 0.21 D , P < 0.0001 ) .


The same seasonal pattern was found by age , sex , ethnicity ( except in the small sample of Asians ) , lens type , and clinical center .


The slower progression of myopia found in summer is likely related to children 's spending more time outdoors and fewer hours in school .


The data have clinical implications regarding the time of year and the frequency with which myopic children have eye examinations and the need for precise timing of visits in clinical trials testing new myopia treatments .


( ClinicalTrials.gov number , NCT00000113 . )


Few studies use longitudinal data to identify predictors of colorectal cancer screening ( CRCS ) .


We examined predictors of ( 1 ) initial CRCS during the first year of a randomized trial , and ( 2 ) repeat CRCS during the second year of the trial among those that completed FOBT in Year 1 .


The sample comprised 1247 participants of the Systems of Support to Increase Colorectal Cancer Screening ( SOS ) Trial ( Group Health Cooperative , August 2008 to November 2011 ) .


Potential predictors of CRCS were identified with logistic regression and included sociodemographics , health history , and validated scales of psychosocial constructs .


Prior CRCS ( OR 2.64 , 95 % CI 1.99-3 .52 ) and intervention group ( Automated : OR 2.06 95 % CI 1.43-2 .95 ; Assisted : OR 4.03 , 95 % CI 2.69-6 .03 ; Navigated : OR 5.64 , 95 % CI 3.74-8 .49 ) were predictors of CRCS completion at Year 1 .


For repeat CRCS at Year 2 , prior CRCS at baseline ( OR 1.97 , 95 % CI 1.25-3 .11 ) , intervention group ( Automated : OR 9.27 , 95 % CI 4.56-18 .82 ; Assisted : OR 11.17 , 95 % CI 5.44-22 .94 ; Navigated : OR 13.10 , 95 % CI 6.33-27 .08 ) , and self-efficacy ( OR 1.32 , 95 % CI 1.00-1 .73 ) were significant predictors .


Self-efficacy and prior CRCS are important predictors of future screening behavior .


CRCS completion increased when access barriers were removed through interventions .


In a 30 week , double-blind , randomized , controlled Phase 3 study in patients with type 2 diabetes mellitus , the addition of fixed-dose exenatide twice daily ( BID ) to titrated insulin glargine resulted in significant glycated hemoglobin ( HbA ( 1c ) ) lowering and weight loss without increased hypoglycemia risk versus titrated insulin glargine alone .


Because individualized insulin titration contributed to these results , this post-hoc analysis examined the results in the context of the degree of insulin titration that occurred .


Subjects on pre-existing insulin glargine ( with or without oral antidiabetes agents ) were randomized to placebo ( n = 123 ) or exenatide BID ( n = 138 ; 5g for 4 weeks , then 10g ongoing ) .


Insulin glargine was titrated in both arms per the Treat-to-Target algorithm .


Tertiles ( T1 , T2 , T3 ) were based on change in insulin dose from baseline to endpoint .


Change in HbA ( 1c ) , hypoglycemia risk , and weight gain were assessed per insulin dose tertile .


The population comprised adult patients ( mean age = 59y ) with type 2 diabetes and an HbA ( 1c ) level between 7.0 % and 10.5 % ( mean HbA ( 1c ) = 8.4 % ) .


Insulin titration ranged from modest reductions in T1 to substantial increases in T3 .


Greater improvements in HbA1c were demonstrated with exenatide BID versus placebo in all tertiles ( statistically significant in T2 and T3 ) .


With exenatide BID , more subjects achieved HbA ( 1c ) < 7.0 % vs. placebo : T1 , 44 % vs. 29 % ( P = not significant ) ; T2 , 65 % vs. 26 % ; T3 , 54 % vs. 29 % ( P < 0.05 for T2 and T3 ) .


Incidence of hypoglycemia was numerically lower with exenatide BID in all tertiles .


Adjunctive exenatide BID was associated with statistically significantly greater weight loss ( T1 , T2 ) or mitigation of weight gain ( T3 ) compared with placebo .


Rates of nausea ( 42 % vs. 8 % ) , diarrhea ( 18 % vs. 7 % ) , and vomiting ( 18 % vs. 4 % ) were higher with exenatide BID than with placebo and did not vary by tertile .


Addition of fixed-dose exenatide BID to optimized insulin glargine , regardless of the extent of insulin titration , significantly improved glycemia without increasing hypoglycemia risk , while mitigating insulin-induced weight gain in this post-hoc analysis .


Remote ischemic preconditioning ( RIPC ) harnesses an innate defensive mechanism that protects against inflammatory activation and ischemia-reperfusion injury , known sequelae of cardiac surgery with cardiopulmonary bypass .


We sought to determine the impact of RIPC on clinical outcomes and physiological markers related to ischemia-reperfusion injury and inflammatory activation after cardiac surgery in children .


Overall , 299 children ( aged neonate to 17 years ) were randomized to receive an RIPC stimulus ( inflation of a blood pressure cuff on the left thigh to 15 mm Hg above systolic for four 5-minute intervals ) versus a blinded sham stimulus during induction with a standardized anesthesia protocol .


Primary outcome was duration of postoperative hospital stay , with serial clinical and laboratory measurements for the first 48 postoperative hours and clinical follow-up to discharge .


There were no significant baseline differences between RIPC ( n = 148 ) and sham ( n = 151 ) .


There were no in-hospital deaths .


No significant difference in length of postoperative hospital stay was noted ( sham 5.4 versus RIPC 5.6 days ; difference +0.2 ; adjusted P = 0.91 ) , with the 95 % confidence interval ( -0.7 to +0.9 ) excluding a prespecified minimal clinically significant differences of 1 or 1.5 days .


There were few significant differences in other clinical outcomes or values at time points or trends in physiological markers .


Benefit was not observed in specific subgroups when explored through interactions with categories of age , sex , surgery type , Aristotle score , or first versus second half of recruitment .


Adverse events were similar ( sham 5 % , RIPC 6 % ; P = 0.68 ) .


RIPC is not associated with important improvements in clinical outcomes and physiological markers after cardiac surgery in children .


clinicaltrials.gov .


Unique identifier : NCT00650507 .


Despite the rapid rise in the implementation of electronic health records ( EHR ) , commensurate improvements in health care quality have not been consistently observed .


To evaluate whether the implementation of EHRs and complementary interventions-including clinical decision support , technical assistance , and financial incentives-improved quality of care .


The study included 143 practices that implemented EHRs as part of the Primary Care Information Project-a long-standing community-based EHR implementation initiative .


A total of 71 practices were randomized to receive financial incentives and quality feedback and 72 were randomized to feedback alone .


All practices received technical assistance and had clinical decision support in their EHR .


Using data from 2009 to 2011 , we estimated measure-level fixed effects models to evaluate the association between exposure to clinical decision support , technical assistance , financial incentives , and quality of care .


Associations were estimated separately for 4 cardiovascular measures that were rewarded by the financial incentive program and 4 measures that were not rewarded by incentives .


Financial incentives for quality were consistently associated with higher performance for the incentivized measures [ +10.1 percentage points at 18 mo of exposure ( approximately +22 % ) , P < 0.05 ] and lower performance for the unincentivized measures [ -8.3 percentage points at 12 mo of exposure ( approximately -20 % ) , P < 0.05 ] .


Technical assistance was associated with higher quality for the unincentivized measures , but not for the incentivized measures .


Technical assistance and financial incentives-alongside EHR implementation-can improve quality of care .


Financial incentives for quality may not result in similar improvements for incentivized and unincentivized measures .


Bariatric surgery improves glycaemia in obese people with type 2 diabetes , but its effects are uncertain in overweight people with this disease .


We aimed to identify whether laparoscopic adjustable gastric band surgery can improve glucose control in people with type 2 diabetes who were overweight but not obese .


We did an open-label , parallel-group , randomised controlled trial between Nov 1 , 2009 , and June 30 , 2013 , at one centre in Melbourne , Australia .


Patients aged 18-65 years with type 2 diabetes and a BMI between 25 and 30 kg/m2 were randomly assigned ( 1:1 ) , by computer-generated random sequence , to receive either multidisciplinary diabetes care plus laparoscopic adjustable gastric band surgery or multidisciplinary diabetes care alone .


The primary outcome was diabetes remission 2 years after randomisation , defined as glucose concentrations of less than 7.0 mmol/L when fasting and less than 11.1 mmol/L 2 h after 75 g oral glucose , at least two days after stopping glucose-lowering drugs .


Analysis was by intention to treat .


This trial is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN12609000286246 .


51 patients were randomised to the multidisciplinary care plus gastric band group ( n = 25 ) or the multidisciplinary care only group ( n = 26 ) , of whom 23 participants and 25 participants , respectively , completed follow-up to 2 years .


12 ( 52 % ) participants in the multidisciplinary care plus gastric band group and two ( 8 % ) participants in the multidisciplinary care only group achieved diabetes remission ( difference in proportions 0.44 , 95 % CI 0.17-0 .71 ; p = 0.0012 ) .


One ( 4 % ) participant in the gastric band group needed revisional surgery and four others ( 17 % ) had a total of five episodes of food intolerance due to excessive adjustment of the band .


When added to multidisciplinary care , laparoscopic adjustable gastric band surgery for overweight people with type 2 diabetes improves glycaemic control with an acceptable adverse event profile .


Laparoscopic adjustable gastric band surgery is a reasonable treatment option for this population .


Monash University Centre for Obesity Research and Education and Allergan .


To determine whether premature infants ' sleep organization , total sleep time , and arousals may be modulated while on a conformational positioner that provides boundaries , customized positioning , and containment compared with standard positioning ( standard crib mattress ) .


A proof of concept trial using a within subject crossover design was conducted among 25 premature infants with feeding difficulties .


Infants of 31.5 weeks gestational age served as their own control during overnight polysomnography at postconceptual age 38.4 weeks .


Each baby received both interventions ( order randomized ) , 1 for each one-half of the 10.5-hour study .


Use of the conformational positioner resulted in higher sleep efficiency of 61 % vs 54 % for the standard mattress ( P < .05 ) .


The interventions did not differ for percent active sleep , percent quiet sleep , percent indeterminate sleep , or spontaneous arousals .


Sleep efficiency was higher on the conformational positioner than standard positioning for surgical subjects and for subjects with necrotizing enterocolitis or gastroschisis ( n = 10 ) .


The surgical subjects ( n = 9 ) had lower sleep efficiency , lower percentage of active sleep , and more spontaneous arousals compared with the nonsurgical group .


The use of the conformational positioner improved sleep efficiency vs the standard mattress in premature infants with feeding difficulties .


Infants requiring surgery or with gastrointestinal diagnoses may be more susceptible to environmental stress .


Increased interest in antiaging methods , mandates a development of reliable noninvasive technique to assess skin aging .


In this study , we aimed to determine the effects of photoaging at histopathologic resolution by means of reflectance confocal microscopy .


The sun-exposed malar area , the anterior aspect of ear lobule , and the sun-protected posterior aspect of ear lobule had been evaluated in 120 volunteers from different age groups over 10 previously reported and new confocal parameters for skin aging .


The sun-exposed areas revealed more frequent irregular honeycomb pattern , polycylic papillary contours , coarse collagen , huddled collagen , curled bright structures with higher epidermal thickness , and furrow depth values .


However , the incidence of thin reticulated collagen and the number of dermal papillae were statistically higher on the sun-protected posterior aspect of ear lobule .


Reflectance confocal microscopy is a reliable diagnostic technique for evaluation of skin photoaging with objective criteria .


With the new emerging compact models it is possible to scan even the least accessible body parts with no discomfort to the patient , which offers the possibility to assess the effect of antiaging applications and to identify early signs of solar damage in cosmetically sensitive areas .


To assess the dose-ranging efficacy and safety of LX4211 , a dual inhibitor of sodium-glucose cotransporter ( SGLT ) 1 and SGLT2 , in type 2 diabetes .


Type 2 diabetic patients inadequately controlled on metformin were randomly assigned to 75 mg once daily , 200 mg once daily , 200 mg twice daily , or 400 mg once daily of LX4211 or placebo .


Primary end point was A1C change from baseline to week 12 .


Secondary end points included changes in blood pressure ( BP ) and body weight .


Baseline characteristics in 299 patients randomly assigned to LX4211 or placebo in this 12-week dose-ranging study were similar : mean age 55.9 years , A1C 8.1 % ( 65 mmol/mol ) , BMI 33.1 kg/m ( 2 ) , and BP 124/79 mmHg .


LX4211 significantly reduced A1C to week 12 in a dose-dependent manner by 0.42 % ( 4.6 mmol/mol ) , 0.52 % ( 5.7 mmol/mol ) , 0.80 % ( 8.7 mmol/mol ) , and 0.92 % ( 10.0 mmol/mol ) , respectively ( P < 0.001 each ) , compared with 0.09 % ( 1.0 mmol/mol ) for placebo .


Greater A1C reductions were produced by 400 mg once a day than 200 mg once a day LX4211 without higher urinary glucose excretion , suggesting a contribution of SGLT1 inhibition .


Significant reductions were seen in body weight ( -1.85 kg ; P < 0.001 ) and systolic BP ( -5.7 mmHg ; P < 0.001 ) , but diastolic BP was unchanged ( -1.6 ; P = 0.164 ) .


Adverse events with LX4211 were mild to moderate and similar to placebo , including urinary tract infections and gastrointestinal-related events ; genital infections were limited to LX4211 groups ( 0-5 .0 % ) .


No hypoglycemia occurred .


Dual inhibition of SGLT1/SGLT2 with LX4211 produced significant dose-ranging improvements in glucose control without dose-increasing glucosuria and was associated with reductions in weight and systolic BP in metformin-treated patients with type 2 diabetes .


The purpose of this study was to evaluate the safety of a novel silver-impregnated Foley catheter system designed to prevent catheter-associated bacteriuria and funguria , assess recruitment feasibility for a future pivotal trial , and preliminarily assess efficacy .


This single-center , randomized controlled trial at a university hospital involved adult neurosurgical patients expected to have a urinary catheter for 24 hours .


Subjects were randomized to a novel silver-impregnated ( test ) Foley catheter system or a control system .


They were followed for 30 days ( or until discharge ) while catheterized and for up to 48 hours after catheter removal , with daily bacteriuria testing and assessment for symptoms of infection and catheter intolerance .


Ninety-five subjects were randomized ( intention-to-treat [ ITT ] population ) .


Of these , 61 subjects ( 64 % ) had a catheter for 24 hours without perioperative antibiotics beyond 24 hours ( evaluable population ) .


In the ITT population , 11 of 95 ( 12 % ) subjects had an asymptomatic bacteriuria ( ABU ) event .


Compared with controls , test system recipients had a trend toward longer time to ABU in the ITT population ( P = .08 , log-rank test ) and a longer time to ABU in the evaluable population ( P = .03 ) .


All 6 ABU events caused by gram-negative bacilli occurred in the control group .


In this pilot randomized trial the test system was well tolerated and seemingly effective in preventing catheter-associated bacteriuria , especially with gram-negative bacilli .


A pivotal study is warranted .


To report 5-year follow-up data of a randomized study comparing high ligation and stripping ( HL + S ) with high ligation and endovenous laser ablation ( HL + EVLA ) of the great saphenous vein ( GSV ) .


One hundred patients were randomized .


After 5 years , patient satisfaction with the overall result , CEAP-C class , VCSS , CIVIQ2 quality of life score , and recurrence rate were assessed ( clinical examination and duplex ultrasound ) .


Five-year follow-up rates were 83 % HL + S and 68 % HL + EVLA .


Patient satisfaction with the overall result was rated good or very good by 88 % after HL + S and 87 % after HL + EVLA .


There were significant improvements for both groups in CEAP-C class ( HL + S 2.28 vs. 1.19 ; HL + EVLA 2.3 vs. 1.17 ) , VCSS ( HL + S 4.79 vs. 1.81 ; HL + EVLA 4.13 vs. 1.87 ) , and CIVIQ2 score ( HL + S 82 vs. 94 ; HL + EVLA 75 vs. 93 ) ( p < .001 ) .


There was no difference in recurrence rates on clinical examination and duplex ultrasound ( HL + S 55 % vs. HL + EVLA 40 % ; p = .217 ) .


A reopened or residual incompetent GSV-partial or complete-was found in 24 % ( HL + S ) and 40 % ( HL + EVLA ) , respectively ( p = .141 ) .


Varicose vein surgery is followed by favorable clinical results and high patient satisfaction , with no difference between HL + S and HL + EVLA .


The randomized , double-blind phase III AFFIRM trial demonstrated that enzalutamide , an oral androgen receptor inhibitor , significantly prolonged overall survival ( OS ) [ median 18.4 versus 13.6 months ( hazard ratio , HR ) 0.63 ( 95 % confidence interval , CI , 0.53-0 .75 ) ; P < 0.001 ] compared with placebo in patients with metastatic castration-resistant prostate cancer who received prior docetaxel chemotherapy .


A post hoc analysis was carried out to assess the efficacy and safety of enzalutamide on outcomes in younger ( < 75 years ) and elderly ( 75 years ) patients in the AFFIRM population .


Statistics are presented by age group ( < 75 years , 75 years ) for efficacy outcomes of OS , radiographic progression-free survival ( rPFS ) , time to prostate-specific antigen ( PSA ) progression , PSA response , and safety .


OS was significantly improved with enzalutamide over placebo in patients < 75 years [ median not yet reached versus 13.6 months ; HR 0.63 ( 95 % CI 0.52-0 .78 ) , P < 0.001 ] and in patients 75 years [ median 18.2 versus 13.3 months ; HR 0.61 ( 95 % CI 0.43-0 .86 ) , P = 0.004 ] , respectively .


rPFS was similarly improved in both the younger [ HR 0.45 ( 95 % CI 0.38-0 .53 ) , P < 0.001 ] and elderly patient cohorts [ HR 0.27 ( 95 % CI 0.20-0 .37 ) , P < 0.001 ] relative to placebo , as were time to PSA progression and PSA response .


Adverse events ( AEs ) were similar between the two enzalutamide age groups , with the exception of an increase in patients75 years in the rates of all grade peripheral edema ( 22.1 % versus 12.5 % ) , fatigue ( 39.7 % versus 31.6 % ) , and diarrhea ( 26.6 % versus 19.6 % ) .


The overall grade3 AE rates were low with no major difference in frequency or severity between age groups or treatment arms .


Five patients were reported with seizure events ; three patients < 75 years and two patients 75 years .


Enzalutamide significantly improves outcomes in both younger ( < 75 years ) and elderly patients ( 75 years ) , with comparable safety and tolerability .


This study sought to evaluate the feasibility of a pilot , dyad-based lifestyle intervention , the Unidas por la Vida program , for improving weight loss and dietary intake among high-risk Mexican American mothers who have Type 2 diabetes and their overweight/obese adult daughters .


Mother-daughter dyads ( N = 89 ) were recruited from two federally qualified health centers and randomly assigned to either the Unidas intervention or to the control condition .


The 16-week Unidas intervention consisted of the following : ( a ) four group meetings , ( b ) eight home visits , and ( c ) booster telephone calls by a lifestyle community coach .


The control condition consisted of educational materials mailed to participants ' homes .


Participants completed surveys at T1 ( baseline ) and T2 ( 16 weeks ) that assessed various demographic , social network involvement , and dietary variables .


Unidas participants lost significantly more weight at T2 ( p < .003 ) compared with the control participants .


Furthermore , intervention participants also were more likely to be eating foods with lower glycemic load ( p < .001 ) and less saturated fat ( p = .004 ) at T2 .


Unidas participants also reported a significant increase in health-related social support and social control ( persuasion control only ) and a decrease in undermining .


The Unidas program promoted weight loss and improved dietary intake , as well as changes in diet-related involvement of participants ' social networks .


The results from this study demonstrate that interventions that draw upon multiple people who share a health-risk have the potential to foster significant changes in lifestyle behaviors and in social network members ' health-related involvement .


Future research that builds on these findings is needed to elucidate the specific dyadic and social network processes that may drive health behavior change .


Despite its salutary effects on health , aerobic exercise is often avoided after receipt of an implantable cardioverter defibrillator ( ICD ) because of fears that exercise may provoke acute arrhythmias .


We prospectively evaluated the effects of a home aerobic exercise training and maintenance program ( EX ) on aerobic performance , ICD shocks , and hospitalizations exclusively in ICD recipients .


A total of 160 patients ( 124 men and 36 women ) were randomly assigned who had an ICD for primary ( 43 % ) or secondary ( 57 % ) prevention to EX or usual care ( UC ) .


The primary outcome was peak oxygen consumption , measured with cardiopulmonary exercise testing at baseline and 8 and 24 weeks .


EX consisted of 8 weeks of home walking for 1 h/d , 5 d/wk at 60 % to 80 % of heart rate reserve , followed by 16 weeks of maintenance home walking for 150 min/wk .


Adherence to EX was determined from exercise logs , ambulatory heart rate recordings of exercise , and weekly telephone contacts .


Patients assigned to UC received no exercise directives and were monitored by monthly telephone contact .


Adverse events were identified by ICD interrogations , patient reports , and medical charts .


ICD recipients averaged 5512 years and mean ejection fraction of 40.615.7 ; all were taking - blocker medications .


EX significantly increased peak oxygen consumption ( EX , 26.77.0 mL/kg per minute ; UC , 23.96.6 mL/kg per minute ; P = 0.002 ) at 8 weeks , which persisted during maintenance exercise at 24 weeks ( EX , 26.97.7 mL/kg per minute ; UC , 23.46.0 mL/kg per minute ; P < 0.001 ) .


ICD shocks were infrequent ( EX = 4 versus UC = 8 ) , with no differences in hospitalizations or deaths between groups .


Prescribed home exercise is safe and significantly improves cardiovascular performance in ICD recipients without causing shocks or hospitalizations .


URL : http://www.clinicaltrials.gov .


Unique identifier : NCT00522340 .


In order to further improve the methodology and quality of data collection in homeopathic drug provings ( HDP ) , there is a need for a minimum standardised HDP protocol .


The objective of the present study was to test the feasibility of this type of protocol .


The study protocol embraced a multi-centre , randomised , double-blind , placebo-controlled trial with 2 parallel groups .


It was approved by an ethics review committee .


During the pre-approval phase , discordances between the regulatory and homeopathic requirements for the protocol were checked and solutions found .


The study medication was Potentilla anserina .


6 participants received verum and 4 placebo .


The resulting symptom list will be published elsewhere .


The procedure was accepted by all participants .


Three important issues were addressed : the requirement to keep all participants blinded ; the adverse events reporting to regulatory authorities ; and the necessity of a placebo control group .


Other issues that need further investigations were identified , e.g. sample size , observation period and dosage regimen .


A minimum protocol of a HDP is feasible .


All important design elements of HDP could be solved in discussions with the respective regulatory authorities , and participating homeopaths accepted the procedure .


Different studies underline the use of pre-operative antibiotic prophylaxis in clean surgeries like herniotomy and inguinal orchiopexy .


But , the meta-analyses do not recommend nor discard the use of prophylactic pre-operative antibiotics .


The scarcity of controlled clinical trials in paediatric population further vitiates the matter .


This study assessed the difference in the rate of early post-operative wound infection cases in children who received single dose of pre-operative antibiotics and children who did not receive antibiotics after inguinal herniotomy and orchiopexy .


This randomised prospective study was conducted in Paediatric Surgery department of PGIMER Chandigarh .


Out of 251 patients , 112 patients were randomised to the case group and 139 were ascribed to the control group .


The patients in control group were given a standard regimen of single dose of intravenous antibiotic at the time of induction followed by 3-4 days of oral antibiotic .


Case group patients underwent the surgical procedure in similar manner with no antibiotic either at the time of induction or post-operatively .


The incidence of surgical site infection in case group was 3.73 % and that in control group was 2.22 % .


The observed difference in the incidence of surgical site infection was statistically insignificant ( P value = 0.7027 ) .


The overall infection rate in case and control group was 2.89 % .


Our preliminary experience suggests that there is no statistically significant difference in the proportion of early post-operative wound infection between the patients who received single dose of pre-operative antibiotics and the patients who received no antibiotics after inguinal herniotomy and orchiopexy .


The risk of surgical site infection in paediatric heriotomies does not increase even if the child 's weight is less than his/her expected weight for age .


Blood donation is known to contribute to iron deficiency in regular blood donors .


This study investigated the safety and efficacy of postdonation iron replacement to mitigate iron deficiency in blood donors .


A total of 282 female whole blood donors aged 18 to 45 were prospectively randomized in a double-blinded placebo controlled trial to receive an 8-week postdonation course of carbonyl iron ( 45mg daily ) or placebo .


The primary endpoint was prevalence of iron deficiency ( ferritin < 15ng/mL ) at 12 weeks postdonation .


Secondary endpoints were eligibility to donate based on capillary hemoglobin ( Hb ) and incidence of gastrointestinal ( GI ) complaints .


Ferritin levels at Week 12 were significantly higher in donors receiving carbonyl iron ( 17.010.9 ng/mL ) compared with those receiving placebo ( 10.68.4 ng/mL ; p < 0.001 ) .


The proportion of iron-deficient donors was significantly lower in the carbonyl iron group ( 51.9 % ) compared to the placebo ( 80.5 % ; p < 0.001 ) .


The mean Hb level in the carbonyl iron group ( 134.68.7 g/L ) was significantly higher than in the placebo arm ( 130.09.9 g/L ; p < 0.001 ) , significantly improving eligibility to donate at Week 12 .


Significantly more donors receiving carbonyl iron had at least one GI side effect ( p < 0.001 ) .


Importantly , 86.7 % of donors receiving carbonyl iron indicated that they would take iron on an ongoing basis .


An 8-week postdonation course of 45mg of carbonyl iron significantly reduced iron deficiency and was well tolerated in female whole blood donors .


Postdonation iron replacement may have a role in a broader strategy to optimize donor iron status .


Severe atherosclerosis in the aortic arch is associated with a high risk of recurrent vascular events , but the optimal antithrombotic strategy is unclear .


This prospective randomized controlled , open-labeled trial , with blinded end point evaluation ( PROBE design ) tested superiority of aspirin 75 to 150 mg/d plus clopidogrel 75 mg/d ( A+C ) over warfarin therapy ( international normalized ratio 2-3 ) in patients with ischemic stroke , transient ischemic attack , or peripheral embolism with plaque in the thoracic aorta > 4 mm and no other identified embolic source .


The primary end point included cerebral infarction , myocardial infarction , peripheral embolism , vascular death , or intracranial hemorrhage .


Follow-up visits occurred at 1 month and then every 4 months post randomization .


The trial was stopped after 349 patients were randomized during a period of 8 years and 3 months .


After a median follow-up of 3.4 years , the primary end point occurred in 7.6 % ( 13/172 ) and 11.3 % ( 20/177 ) of patients on A+C and on warfarin , respectively ( log-rank , P = 0.2 ) .


The adjusted hazard ratio was 0.76 ( 95 % confidence interval , 0.36-1 .61 ; P = 0.5 ) .


Major hemorrhages including intracranial hemorrhages occurred in 4 and 6 patients in the A+C and warfarin groups , respectively .


Vascular deaths occurred in 0 patients in A+C arm compared with 6 ( 3.4 % ) patients in the warfarin arm ( log-rank , P = 0.013 ) .


Time in therapeutic range ( 67 % of the time for international normalized ratio 2-3 ) analysis by tertiles showed no significant differences across groups .


Because of lack of power , this trial was inconclusive and results should be taken as hypothesis generating .


http://www.clinicaltrials.gov .


Unique identifier : NCT00235248 .


A ` fast-track protocol ' in surgery suggests the application of evidence-based practices to expedite patient recovery .


It has shown to reduce hospital stay , hasten recovery as well as facilitate earlier return to work .


It has a considerable impact in reducing healthcare costs .


The basic tenet is to treat the patient 's disease by minimal disturbance of their physiology .


The protocol encompasses pre-operative , intra-operative and post-operative interventions which when carried out together would show maximal benefits .


The surgeon is usually the leader of the team managing the patient , but it can not be over-emphasised that this is a multi-disciplinary team approach .


We conducted a prospective interventional study to investigate whether ` fast-track ' surgery protocols improve patient outcome when compared to traditional peri-operative care followed at our institute .


By doing so , we observed that the patients who underwent ` fast tracking ' required lesser analgesia , had earlier ambulation , earlier return of intestinal motility , were free from tubes , catheters and drains earlier and lastly were discharged earlier .


This was achieved without a rise in complications or re-admissions .


The results have proved that implementing the fast-track protocol for gastrointestinal surgeries is not only safe and effective , but also improves patient outcome .


Role of prophylactic antibiotics in Milligan Morgan hemorrhoidectomy - A prospective , randomized control trial .


Randomized control trial .


Combined Military Hospital Malir , Bannu and HIT hospital Taxilla , September 2008 to February 2011 .


Patients undergoing Milligan Morgan hemorrhoidectomy for grade III and IV hemorrhoids were randomized in 2 groups by using computer generated table .


Group A did not receive any prophylactic antibiotic whereas group B received 500 mg I/V metronidazole and 1 g Ceftriaxone I/V before induction of anesthesia .


All the patients had standardized post operative care .


Pain scores on 100 mm Visual Analogue Scale and consumption of oral analgesics were noted from 1st to 7th post operative day .


Time required for complete healing was also noted .


Data was entered on SPSS 16.0 and p value was calculated .


Out of 100 patients , 96 patients ( 47 in group A and 49 in group B ) completed the study .


Demographical data was comparable in both the groups .


There was no difference in the pain scores , analgesic consumption and rate of healing between both the groups .


Prophylactic antibiotics have got no role in cases of Milligan Morgan hemorrhoidectomy .


Cardiac troponin is the biochemical gold standard to diagnose acute myocardial infarction .


Interestingly however , elevated cardiac troponin concentrations are also frequently observed during and after endurance-type exercise .


Oxidative stress associated with prolonged exercise has been proposed to contribute to cardiac troponin release .


Therefore , the aim of this study was to assess the effect of 4 week astaxanthin supplementation ( a potent cartenoid antioxidant ) on antioxidant capacity and exercise-induced cardiac troponin release in cyclists .


Thirty-two well-trained male cyclists ( age 255 , weight 737 kg , maximum O2 uptake 605 mLkg ( -1 ) min ( -1 ) , Wmax 5.40.5 Wkg ( -1 ) ; mean SD ) were repeatedly subjected to a laboratory based standardized exercise protocol before and after 4 weeks of astaxanthin ( 20 mg/day ) , or placebo supplementation in a double-blind randomized manner .


Blood samples were obtained at baseline , at 60 min of cycling and immediately post-exercise ( 120 min ) .


The pre-supplementation cycling trial induced a significant rise of median cardiac troponin T concentrations from 3.2 ( IQR 3.0-4 .2 ) to 4.7 ng/L ( IQR 3.7-6 .7 ) , immediately post-exercise ( p < 0.001 ) .


Four weeks of astaxanthin supplementation significantly increased mean basal plasma astaxanthin concentrations from non-detectable values to 17586 gkg ( -1 ) .


However , daily astaxanthin supplementation had no effect on exercise-induced cardiac troponin T release ( p = 0.24 ) , as measured by the incremental area under the curve .


Furthermore , the elevation in basal plasma astaxanthin concentrations was not reflected in changes in antioxidant capacity markers ( trolox equivalent antioxidant capacity , uric acid , and malondialdehyde ) .


Markers of inflammation ( high-sensitivity C-reactive protein ) and exercise-induced skeletal muscle damage ( creatine kinase ) were equally unaffected by astaxanthin supplementation .


Despite substantial increases in plasma astaxanthin concentrations , astaxanthin supplementation did not improve antioxidant capacity in well-trained cyclists .


Accordingly , exercise-induced cardiac troponin T concentrations were not affected by astaxanthin supplementation .


ClinicalTrials.gov NCT01241877 .


To assess the differences in facial skin temperature after mandibular third molar removal when patients received methylprednisolone and placebo , respectively and to assess the correlation between patient-reported swelling using a visual analog scale ( VAS ) and facial skin temperature measured using thermography .


The study involved patients with 2 mandibular third molars with an indication for removal .


The patients received either methylprednisolone or placebo in a randomized , crossover study design .


Thermograms and the swelling VAS score were recorded 2 days after surgery .


The outcome variable was the temperature difference ( t ) between the operated and control sides .


A 2-sample t test analyzed the difference in t between the first and second operations .


Spearman 's rank correlation analysis was used to assess the correlation between the swelling VAS scores and the t.


A total of 124 patients ( 67 males , 57 females , mean age 25 years ) had both mandibular third molars removed on 2 separate occasions .


No difference in t was found when methylprednisolone and placebo were given ( P = .07 ) .


In addition , the correlation between the swelling VAS score and t was 0.30 ( P = .001 ) and 0.09 ( P = .3 ) after the first and second operation , respectively .


Thermography does not seem sensitive enough to detect differences in the inflammatory response when patients received methylprednisolone or placebo .


The correlation between the t and patient-reported swelling was low ( 0.3 ) .


Posterior rectal dissection during ileal pouch-anal anastomosis ( IPAA ) can be performed in the total mesorectal excision ( TME ) or close rectal dissection ( CRD ) plane .


The aim of this study was to compare morbidity and quality of life ( QoL ) in patients having TME or CRD during proctectomy followed by IPAA for benign disease .


In this randomized clinical trial , patients undergoing IPAA were allocated to TME or CRD .


Thirty-day morbidity was determined and QoL assessed using Short Form 36 , GIQLI ( GastroIntestinal Quality of Life Index ) and COREFO ( COloREctal Functional Outcome ) questionnaires .


The primary outcome ( pouch compliance ) of the trial is to be reported separately .


Fifty-nine patients were included , 28 in the CRD and 31 in the TME group .


Baseline data were similar , except for more previous abdominal surgery in the TME group .


Operating time was longer for patients having CRD ( 195min versus 166min for TME ; P = 0008 ) .


More patients in the TME group had a primary defunctioning ileostomy ( 7 of 31 versus 1 of 28 for CRD ; P = 0055 ) .


Severe complications occurred more frequently in the TME group ( 10 of 31 versus 2 of 28 for CRD ) .


QoL was better in the CRD group for several subscales of the questionnaires measured at 1 , 3 and 6 months after surgery .


At 12 months , QoL was similar in the two groups for all subscales .


CRD led to a lower severe complication rate and better short-term QoL than wide TME .


Chronic peanut consumption is associated with health benefits .


To encourage consumption , peanuts are marketed with various flavorings , but questions have been raised as to whether seasonings offset the benefits of peanuts alone .


This study sought to determine whether flavorings on peanuts affect health benefits over 12 wk .


In a randomized , parallel-group trial , 151 participants received 42 g peanuts/d as 14-g servings of 3 different flavors ( n = 50 ) or a single flavor ( n = 25-26 / group ) .


Anthropometric indexes , blood pressure , and heart rate were measured biweekly .


Cardiovascular disease risk factors ( serum lipids , insulin , glucose , and cortisol ) were assessed monthly .


No single added flavor differentially altered body weight , body fat , body mass index , heart rate , or blood indexes in the total sample .


Participants at greater risk of cardiovascular disease had significantly greater mean ( SE ) reductions in diastolic blood pressure ( -5.0 1.7 mm Hg compared with -0.7 0.6 mm Hg ) , cholesterol ( -12.1 8.5 mg/dL compared with +5.6 2.0 mg/dL ) , and triglycerides ( -31.7 15.8 mg/dL compared with +2.3 3.0 mg/dL ) ( n = 27 , 24 , and 15 , respectively ; P < 0.01 ) than did those at lower risk , who did not have significantly different cholesterol or triglyceride concentrations .


Consumption of a variety of flavors led to greater weight gain ( 0.9 0.3 kg ) compared with individual flavors alone ( 0.5 0.2 kg ) ( P < 0.05 ) , but increases in fat and lean masses were not significant .


Regardless of flavoring , peanut consumption offered significant benefits to participants with elevated serum lipids and blood pressure .


Sensory variety led to a small , but significant , increase in body weight in comparison with ingestion of a single flavor but no change in fat mass .


To evaluate an evidence-based collaborative depression care intervention adapted to obstetrics and gynecology clinics compared with usual care .


A two-site , randomized controlled trial included screen-positive women ( Patient Health Questionnaire-9 score of at least 10 ) who met criteria for major depression , dysthymia , or both ( Mini-International Neuropsychiatric Interview ) .


Women were randomized to 12 months of collaborative depression management or usual care ; 6-month , 12-month , and 18-month outcomes were compared .


The primary outcomes were change from baseline to 12 months in depression symptoms and functional status .


Secondary outcomes included at least 50 % decrease and remission in depressive symptoms , global improvement , treatment satisfaction , and quality of care .


Participants were , on average , 39 years old , 44 % were nonwhite , and 56 % had posttraumatic stress disorder .


Intervention ( n = 102 ) compared with usual care ( n = 103 ) patients had greater improvement in depressive symptoms at 12 months ( P < .001 ) and 18 months ( P = .004 ) .


The intervention group compared with usual care group had improved functioning over the course of 18 months ( P < .05 ) , were more likely to have at least 50 % decrease in depressive symptoms at 12 months ( relative risk [ RR ] 1.74 , 95 % confidence interval [ CI ] 1.11-2 .73 ) , greater likelihood of at least four specialty mental health visits ( 6-month RR 2.70 , 95 % CI 1.73-4 .20 ; 12-month RR 2.53 , 95 % CI 1.63-3 .94 ) , adequate dose of antidepressant ( 6-month RR 1.64 , 95 % CI 1.03-2 .60 ; 12-month RR 1.71 , 95 % CI 1.08-2 .73 ) , and greater satisfaction with care ( 6-month RR 1.70 , 95 % CI 1.19-2 .44 ; 12-month RR 2.26 , 95 % CI 1.52-3 .36 ) .


Collaborative depression care adapted to women 's health settings improved depressive and functional outcomes and quality of depression care .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT01096316 .


I.


Rosacea subtype 1 ( erythematotelangiectatic ) is an inflammatory skin disease with limited treatment options .


TDT 068 , a topical drug-free gel containing ultra-deformable Sequessome vesicles , is registered for use in inflammatory skin conditions , but has not been investigated in rosacea .


This postmarketing study aimed to substantiate the effects of TDT 068 in rosacea subtype 1 .


Patients aged 18-85 scoring 6-15/30 for the primary and secondary features of the rosacea standard grading system ( RSGS ) were enrolled .


Following stratification ( four females/one male ) patients were randomized ( 2:1 ) to receive TDT 068 or vehicle gel for 4weeks .


Efficacy was evaluated using the patient-rated rosacea-specific quality of life ( R-QOL ) instrument and investigator-rated RSGS .


Adverse events ( AEs ) were monitored throughout .


Of the 61 randomized patients , 58 were eligible for the full analysis set per protocol .


Baseline characteristics were balanced across the groups .


R-QOL symptom construct scores improved slightly from baseline to Week 4 in both groups ( -0.040.51 TDT 068 vs. -0.220.59 vehicle ; P = 0.1990 ) .


Changes in R-QOL total , function and emotion construct scores at Week 4 were similar with TDT 068 and vehicle , but TDT 068 yielded numerically greater increases in total RSGS scores ( -1.551.83 vs. -0.752.38 vehicle ; P = 0.105 ) .


Non-transient erythema improved significantly with TDT 068 at Week 4 ( -0.340.63 vs. -0.050.51 vehicle ; P = 0.044 ) , with 1 grade improvement in 35 % of patients ( vs. 15 % vehicle ; P = 0.039 ) .


Numerically greater improvements in transient erythema and telangiectasia were also seen with TDT 068 .


Three treatment-related AEs were reported but no serious AEs occurred .


These data , based on investigator assessment , provide evidence for the good tolerability of drug-free TDT 068 as well as modest improvements in the symptoms of erythematotelangiectatic rosacea .


Amiodarone is an effective medication in preventing atrial fibrillation ( AF ) , but it interferes with the metabolism of warfarin .


This study sought to examine the association of major thrombotic clinical events and bleeding with the use of amiodarone in the ARISTOTLE ( Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation ) trial .


Baseline characteristics of patients who received amiodarone at randomization were compared with those who did not receive amiodarone .


The interaction between randomized treatment and amiodarone was tested using a Cox model , with main effects for randomized treatment and amiodarone and their interaction .


Matching on the basis of a propensity score was used to compare patients who received and who did not receive amiodarone at the time of randomization .


In ARISTOTLE , 2,051 ( 11.4 % ) patients received amiodarone at randomization .


Patients on warfarin and amiodarone had time in the therapeutic range that was lower than patients not on amiodarone ( 56.5 % vs. 63.0 % ; p < 0.0001 ) .


More amiodarone-treated patients had a stroke or a systemic embolism ( 1.58 % / year vs. 1.19 % / year ; adjusted hazard ratio [ HR ] : 1.47 , 95 % confidence interval [ CI ] : 1.03 to 2.10 ; p = 0.0322 ) .


Overall mortality and major bleeding rates were elevated , but were not significantly different in amiodarone-treated patients and patients not on amiodarone .


When comparing apixaban with warfarin , patients who received amiodarone had a stroke or a systemic embolism rate of 1.24 % / year versus 1.85 % / year ( HR : 0.68 , 95 % CI : 0.40 to 1.15 ) , death of 4.15 % / year versus 5.65 % / year ( HR : 0.74 , 95 % CI : 0.55 to 0.98 ) , and major bleeding of 1.86 % / year versus 3.06 % / year ( HR : 0.61 , 95 % CI : 0.39 to 0.96 ) .


In patients who did not receive amiodarone , the stroke or systemic embolism rate was 1.29 % / year versus 1.57 % / year ( HR : 0.82 , 95 % CI : 0.68 to 1.00 ) , death was 3.43 % / year versus 3.68 % / year ( HR : 0.93 , 95 % CI : 0.83 to 1.05 ) , and major bleeding was 2.18 % / year versus 3.03 % / year ( HR : 0.72 , 95 % CI : 0.62 to 0.84 ) .


The interaction p values for amiodarone use by apixaban treatment effects were not significant .


Amiodarone use was associated with significantly increased stroke and systemic embolism risk and a lower time in the therapeutic range when used with warfarin .


Apixaban consistently reduced the rate of stroke and systemic embolism , death , and major bleeding compared with warfarin in amiodarone-treated patients and patients who were not on amiodarone .


To evaluate the clinical efficacy and safety of treatment of chronic primary glomerulopathy ( CPG ) patients of Shen deficiency and dampness heat syndrome ( SDDHS ) by Yishen Qingli Granule ( YQG ) combined with low-dose Tripterygium Wilfordii multiglycoside Tablet ( TWT ) .


Totally 231 CPG patients of SDDHS were enrolled in this study ( including 60 patients from First Affiliated Hospital of Nanjing University of Chinese Medicine , 58 from First Affiliated Hospital of Nanjing Medical University , 46 from Xinqiao Hospital of Third Military Medical University , 35 from First Affiliated Hospital of Guangzhou University of Chinese Medicine , 14 from First Affiliated Hospital of Soochow University , and 18 from Wuxi Affiliated Hospital of Nanjing University of Chinese Medicine ) .


They were randomly assigned to the control group ( 116 cases ) and the trial group ( 115 cases ) according to block group method .


There were 217 cases in the safety analysis set ( 109 cases in the trial group vs 108 cases in the control group ) , and 203 cases in the full analysis set ( 99 cases in the trial group vs 104 cases in the control group ) .


All patients received basic treatment such as ACEI/ARB .


Furthermore , YQG ( consisting of raw astragalus 10 g , prepared Polygonum Multiflorum 10 g , Pyrrosia 10 g , 1.5 g each package , containing 10 g of crude drugs ) was additionally given to patients in the trial group , each package , twice daily .


The TWT ( 10 mg ) was given , twice a day .


The TWT dose was adjusted according to 24 h urinary total protein ( UTP ) .


The placebos of YQG and TWT were administered to those in the control group .


The treatment course consisted of 24 weeks and the follow-up visit lasted for 24 weeks .


The biochemical indices were observed before and after treatment including 24 h UTP , urine red cell count ( U ( RBC ) ) , renal functions ( BUN , SCr ) , blood routine test ( WBC ) , and liver functions ( SGPT , SGOT ) .


Reverse reactions such as gastrointestinal discomfort , skin rash , and irregular menstruation were also observed .


Compared with the control group , the total effective rate was better in the trial group ( 82.83 % vs 61.54 % , P < 0.01 ) .


Results of stratified comparison of UTP showed better efficacy in the trial group ( 0.8-3 .0 g/24 h , P < 0.01 ) .


The UTP decline occurred in the trial group after 8 weeks of treatment , with stable action , showing statistical difference when compared with the control group ( P < 0.01 ) .


In the trial group , U ( RBC ) level decreased after treatment but changed more significantly .


But there was no statistical difference in the changes when compared with the control group ( P > 0.05 ) .


After treatment , there were no statistical difference in safety indicators such as WBC , SGPT , and SGOT between the two groups after treatment ( P > 0.05 ) .


On the basis of basic treatment such as ACEI/ARB , application of YQG combined with low-dose TWT had better effect in controlling proteinuria of CPG patients , and could help stabilizing their conditions with less adverse reactions .


It has been suggested that pancreaticogastrostomy ( PG ) is a safer reconstruction than pancreaticojejunostomy ( PJ ) , resulting in lower morbidity , including lower pancreatic leak rates and decreased postoperative mortality .


We compared PJ and PG after pancreaticoduodenectomy ( PD ) .


A randomized clinical trial was designed .


It was stopped with 50 % accrual .


Patients underwent either PG or PJ reconstruction .


The primary outcome was the pancreatic fistula rate , and the secondary outcomes were overall morbidity and mortality .


We used the Student t , Mann-Whitney U and ( 2 ) tests for intention to treat analysis .


The effect of randomization , American Society of Anesthesiologists score , soft pancreatic texture and use of pancreatic stent on overall complications and fistula rates was calculated using logistic regression .


Our trial included 98 patients .


The rate of pancreatic fistula formation was 18 % in the PJ and 25 % in the PG groups ( p = 0.40 ) .


Postoperative complications occurred in 48 % of patients in the PJ and 58 % in the PG groups ( p = 0.31 ) .


There were no significant predictors of overall complications in the multivariate analysis .


Only soft pancreatic gland predicted the occurrence of pancreatic fistula ( odds ratio 5.89 , p = 0.003 ) .


There was no difference in the rates of pancreatic leak/fistula , overall complications or mortality between patients undergoing PG and and those undergoing PJ after PD .


This study aims to determine the dose-dependent effects of testosterone on sexual function , body composition , muscle performance , and physical function in hysterectomized women with or without oophorectomy .


Seventy-one postmenopausal women who previously underwent hysterectomy with or without oophorectomy and had total testosterone levels less than 31 ng/dL or free testosterone levels less than 3.5 pg/mL received a standardized transdermal estradiol regimen during the 12-week run-in period and were randomized to receive weekly intramuscular injections of placebo or 3 , 6.25 , 12.5 , or 25 mg of testosterone enanthate for 24 weeks .


Total and free testosterone levels were measured by liquid chromatography-tandem mass spectrometry and equilibrium dialysis , respectively .


The primary outcome was change in sexual function measured by the Brief Index of Sexual Functioning for Women .


Secondary outcomes included changes in sexual activity , sexual distress , Derogatis Interview for Sexual Functioning , lean body mass , fat mass , muscle strength and power , and physical function .


Seventy-one women were randomized ; five groups were similar at baseline .


Sixty-two women with analyzable data for the primary outcome were included in the final analysis .


The mean on-treatment total testosterone concentrations were 19 , 78 , 102 , 128 , and 210 ng/dL in the placebo , 3-mg , 6.25-mg , 12.5-mg , and 25-mg groups , respectively .


Changes in composite Brief Index of Sexual Functioning for Women scores , thoughts/desire , arousal , frequency of sexual activity , lean body mass , chest-press power , and loaded stair-climb power were significantly related to increases in free testosterone concentrations ; compared with placebo , changes were significantly greater in women assigned to the 25-mg group , but not in women in the lower-dose groups .


Sexual activity increased by 2.7 encounters per week in the 25-mg group .


The frequency of androgenic adverse events was low .


Testosterone administration in hysterectomized women with or without oophorectomy for 24 weeks was associated with dose and concentration-dependent gains in several domains of sexual function , lean body mass , chest-press power , and loaded stair-climb power .


Long-term trials are needed to weigh improvements in these outcomes against potential long-term adverse effects .


To determine whether active negative pressure peritoneal therapy with the ABThera temporary abdominal closure device reduces systemic inflammation after abbreviated laparotomy .


Excessive systemic inflammation after abdominal injury or intra-abdominal sepsis is associated with poor outcomes .


We conducted a single-center , randomized controlled trial .


Forty-five adults with abdominal injury ( 46.7 % ) or intra-abdominal sepsis ( 52.3 % ) were randomly allocated to the ABThera ( n = 23 ) or Barker 's vacuum pack ( n = 22 ) .


On study days 1 , 2 , 3 , 7 , and 28 , blood and peritoneal fluid were collected .


The primary endpoint was the difference in the plasma concentration of interleukin-6 ( IL-6 ) 24 and 48 hours after temporary abdominal closure application .


There was a significantly lower peritoneal fluid drainage from the ABThera at 48 hours after randomization .


Despite this , there was no difference in plasma concentration of IL-6 at baseline versus 24 ( P = 0.52 ) or 48 hours ( P = 0.82 ) between the groups .


There was also no significant intergroup difference in the plasma concentrations of IL-1 , -8 , -10 , or -12 p70 or tumor necrosis factor between these time points .


The cumulative incidence of primary fascial closure at 90 days was similar between groups ( hazard ratio , 1.6 ; 95 % confidence interval , 0.82-3 .0 ; P = 0.17 ) .


However , 90-day mortality was improved in the ABThera group ( hazard ratio , 0.32 ; 95 % confidence interval , 0.11-0 .93 ; P = 0.04 ) .


This trial observed a survival difference between patients randomized to the ABThera versus Barker 's vacuum pack that did not seem to be mediated by an improvement in peritoneal fluid drainage , fascial closure rates , or markers of systemic inflammation .


ClinicalTrials.gov identifier NCT01355094 .


Type 1 diabetes results from T-cell-mediated destruction of cells .


Findings from preclinical studies and pilot clinical trials suggest that antithymocyte globulin ( ATG ) might be effective for reducing this autoimmune response .


We assessed the safety and efficacy of rabbit ATG in preserving islet function in participants with recent-onset type 1 diabetes , and report here our 12-month results .


For this phase 2 , randomised , placebo-controlled , clinical trial , we enrolled patients with recent-onset type 1 diabetes , aged 12-35 years , and with a peak C-peptide of 0.4 nM or greater on mixed meal tolerance test from 11 sites in the USA .


We used a computer generated randomisation sequence to randomly assign patients ( 2:1 , with permuted-blocks of size three or six and stratified by study site ) to receive either 6.5 mg/kg ATG or placebo over a course of four days .


All participants were masked and initially managed by an unmasked drug management team , which managed all aspects of the study until month 3 .


Thereafter , to maintain masking for diabetes management throughout the remainder of the study , participants received diabetes management from an independent , masked study physician and nurse educator .


The primary endpoint was the baseline-adjusted change in 2-h area under the curve C-peptide response to mixed meal tolerance test from baseline to 12 months .


Analyses were by intention to treat .


This is a planned interim analysis of an on-going trial that will run for 24 months of follow-up .


This study is registered with ClinicalTrials.gov , number NCT00515099 .


Between Sept 10 , 2007 , and June 1 , 2011 , we screened 154 individuals , randomly allocating 38 to ATG and 20 to placebo .


We recorded no between-group difference in the primary endpoint : participants in the ATG group had a mean change in C-peptide area under the curve of -0.195 pmol/mL ( 95 % CI -0.292 to -0.098 ) and those in the placebo group had a mean change of -0.239 pmol/mL ( -0.361 to -0.118 ) in the placebo group ( p = 0.591 ) .


All except one participant in the ATG group had both cytokine release syndrome and serum sickness , which was associated with a transient rise in interleukin-6 and acute-phase proteins .


Acute T cell depletion occurred in the ATG group , with slow reconstitution over 12 months .


However , effector memory T cells were not depleted , and the ratio of regulatory to effector memory T cells declined in the first 6 months and stabilised thereafter .


ATG-treated patients had 159 grade 3-4 adverse events , many associated with T-cell depletion , compared with 13 in the placebo group , but we detected no between-group difference in incidence of infectious diseases .


Our findings suggest that a brief course of ATG does not result in preservation of - cell function 12 months later in patients with new-onset type 1 diabetes .


Generalised T-cell depletion in the absence of specific depletion of effector memory T cells and preservation of regulatory T cells seems to be an ineffective treatment for type 1 diabetes .


To determine the efficacy of single-dose albendazole ( 400 mg ) for soil-transmitted helminth infections ( STH ) in schoolchildren living in one community of the city of Iquitos , Per .


Within the context of a randomized controlled trial performed in a peri-urban community of limited resources located in Iquitos in the Peruvian Amazon , stool specimens were collected from Grade 5 schoolchildren in 18 schools and analysed for STH prevalence and intensity .


A total of 1,193 school-age children were then dewormed with single-dose albendazole ( 400 mg ) .


Of the 909 children who were found positive with at least one STH infection , a random sample of 385 was followed two weeks later when a second stool specimen was collected and analyzed .


The efficacy of albendazole was satisfactory : for Ascaris lumbricoides , with an egg reduction rate ( ERR ) of 99.8 % ; ( 95 % CI : 99.3-100 ) ; for hookworm , with an ERR of 93.6 % ; ( 95 % CI : 88.2-96 .6 ) and , for Trichuris trichiura , with an ERR of 72.7 % ; ( 95 % CI : 58.5-79 .1 ) .


These results are consistent with previous data published on the efficacy of albendazole and the directives of the World Health Organization .


Future research should focus on improving the efficacy of the treatment strategies for Trichuris trichiura infection .


Determine the efficacy of a fall-prevention skills training program for patients with cancer and family caregivers .


Randomized , controlled trial with repeated measures and postintervention measure of fall occurrence .


A comprehensive cancer center in the midwestern United States .


132 patient and family caregiver dyads .


Dyads were randomly assigned to one of two groups : a control group that received standard fall-prevention education or a treatment group that received standard education and a fall-prevention DVD program to view at home .


Participants completed surveys at baseline , one week , one month , and three months .


Follow-up phone calls were made at three months .


Fall occurrence , perceptions of fall risks , and fall-prevention knowledge .


Patients in the treatment group were significantly more likely to report not falling at three months than patients in the control group .


The number of falls was lower for the treatment group .


The difference was not statistically significant .


Dyads in the treatment group showed significantly greater improvement over time in fall risk awareness and fall-prevention knowledge .


Mobility skills training is a promising educational intervention for reducing fall occurrences in the home for patients with cancer .


Efforts are needed for improving the knowledge and skills of cancer survivors and their family members in recognizing patient fall risks , making home adjustments , and performing mobility skills competently .


This study examined the usefulness of nasal Duo positive airway pressure ( DuoPAP ) in the treatment of very low birth weight preterm infants with neonatal respiratory distress syndrome ( NRDS ) .


Eighty-five very low birth weight preterm infants with NRDS were randomly divided into two groups .


Forty-five infants were treated with DuoPAP , while 40 infants were treated using nasal continuous positive airway pressure ( nCPAP ) .


The study outcomes were pH , PaCO , PaO , oxygenation index ( PaO/FiO ) , and the number of failure cases at 1 , 12 , and 24 hours after non-invasive respiratory support .


At all studied time points , after non-invasive respiratory support , PaCO , PaO and oxygenation index were significantly ( p < 0.05 ) better in the nasal DuoPAP group compared with nasal CPAP group .


In addition , rates of failure of assisted ventilation ( respectively , 4.44 % vs. 22.50 % ) and the occurrence of apnea ( 13.33 % vs. 32.50 % ) were significantly ( p < 0.05 ) better in the nasal DuoPAP group .


Other parameters ( such as duration of noninvasive ventilation , number of retinopathies of premature children , intraventricular hemorrhages , or periventricular leukomalacias ) were comparable between both non-invasive regimen .


Nasal DuoPAP better improves oxygenation , reduces CO retention , and diminishes the need for invasive mechanical ventilation and complications in the treatment of NRDS .


The specific job demands of working in a hospital may place nurses at elevated risk for developing distress , anxiety and depression .


Screening followed by referral to early interventions may reduce the incidence of these health problems and promote work functioning .


To evaluate the comparative cost-effectiveness of two strategies to promote work functioning among nurses by reducing symptoms of mental health complaints .


Three conditions were compared : the control condition consisted of online screening for mental health problems without feedback about the screening results .