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


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


Both groups will receive @ mg transdermal nicotine patches for @-@ weeks and withdrawal-orientated behavioural support for @ sessions .


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


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


Follow-up will take place at @ weeks , @ months and @ 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 .


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 @ years of age , had been receiving ART for more than @ 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 @ or @ .


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


The median age was @ years ( interquartile range , @ to @ ) , and the median CD@ T-cell percentage was @ % ( interquartile range , @ to @ ) .


Participants who stopped co-trimoxazole had higher rates of hospitalization or death than those who continued ( @ participants -LSB- @ % -RSB- vs. @ -LSB- @ % -RSB- ; hazard ratio , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ; noninferiority not shown ) .


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


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


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


Rates of adverse events of grade @ or @ were similar in the two groups ( hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) , but more grade @ adverse events occurred in the prophylaxis-stopped group ( hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) , with anemia accounting for the largest number of events ( @ , vs. @ with continued prophylaxis ) .


Continuing co-trimoxazole prophylaxis after @ 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 , ISRCTN@ . )


This study seeks to determine if variation in the dopamine transporter gene ( SLC@A@/DAT@ ) 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 = @ ) participated in a double-blind , two period crossover , dose-response study with a randomized placebo week in each @ week drug period .


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


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


ADHD youth with the @/@ 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 : ( @ ) ultrasound alone ( n = @ ) ; ( @ ) ultrasound and electrical stimulation through the needle ( n = @ ) ; or ( @ ) ultrasound and electrical stimulation through both the needle and catheter ( n = @ ) .


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


The stimulating needle group was significantly noninferior to the stimulating catheter group ( difference -LSB- @ % CI -RSB- in mean verbal response scale pain score -LSB- stimulating needle vs. stimulating catheter -RSB- of -@ -LSB- -@ to @ -RSB- , P < @ ; percentage difference in mean IV morphine equivalent dose of -@ % -LSB- -@ to @ % -RSB- , P = @ ) and to ultrasound-only group ( difference in mean verbal response scale pain score of -@ -LSB- -@ to @ -RSB- , P < @ ; percentage difference in mean IV morphine equivalent dose of -@ % -LSB- -@ to @ % -RSB- , P = @ ) .


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 @ myopic @ - to < @ year-old children was randomized to single vision or progressive addition lenses and followed for @ years with @ % retention .


Progression of myopia was measured semiannually by noncycloplegic autorefraction ( Nidek ARK @A ) 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 @ .


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 @ children ( mean -LSB- SD -RSB- age = @ @ years ; mean myopia = -@ @ diopters -LSB- D -RSB- ) 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 -@ @ D and in summer was -@ @ D , a statistically significant difference ( @ D , P < @ ) .


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 , NCT@ . )


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


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


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


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


Prior CRCS ( OR @ , @ % CI @-@ @ ) and intervention group ( Automated : OR @ @ % CI @-@ @ ; Assisted : OR @ , @ % CI @-@ @ ; Navigated : OR @ , @ % CI @-@ @ ) were predictors of CRCS completion at Year @ .


For repeat CRCS at Year @ , prior CRCS at baseline ( OR @ , @ % CI @-@ @ ) , intervention group ( Automated : OR @ , @ % CI @-@ @ ; Assisted : OR @ , @ % CI @-@ @ ; Navigated : OR @ , @ % CI @-@ @ ) , and self-efficacy ( OR @ , @ % CI @-@ @ ) 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 @ week , double-blind , randomized , controlled Phase @ study in patients with type @ diabetes mellitus , the addition of fixed-dose exenatide twice daily ( BID ) to titrated insulin glargine resulted in significant glycated hemoglobin ( HbA ( @c ) ) 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 = @ ) or exenatide BID ( n = @ ; @g for @ weeks , then @g ongoing ) .


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


Tertiles ( T@ , T@ , T@ ) were based on change in insulin dose from baseline to endpoint .


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


The population comprised adult patients ( mean age = @y ) with type @ diabetes and an HbA ( @c ) level between @ % and @ % ( mean HbA ( @c ) = @ % ) .


Insulin titration ranged from modest reductions in T@ to substantial increases in T@ .


Greater improvements in HbA@c were demonstrated with exenatide BID versus placebo in all tertiles ( statistically significant in T@ and T@ ) .


With exenatide BID , more subjects achieved HbA ( @c ) < @ % vs. placebo : T@ , @ % vs. @ % ( P = not significant ) ; T@ , @ % vs. @ % ; T@ , @ % vs. @ % ( P < @ for T@ and T@ ) .


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


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


Rates of nausea ( @ % vs. @ % ) , diarrhea ( @ % vs. @ % ) , and vomiting ( @ % vs. @ % ) 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 , @ children ( aged neonate to @ years ) were randomized to receive an RIPC stimulus ( inflation of a blood pressure cuff on the left thigh to @ mm Hg above systolic for four @-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 @ postoperative hours and clinical follow-up to discharge .


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


There were no in-hospital deaths .


No significant difference in length of postoperative hospital stay was noted ( sham @ versus RIPC @ days ; difference +@ ; adjusted P = @ ) , with the @ % confidence interval ( -@ to +@ ) excluding a prespecified minimal clinically significant differences of @ or @ 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 @ % , RIPC @ % ; P = @ ) .


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


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


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


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


Using data from @ to @ , 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 @ cardiovascular measures that were rewarded by the financial incentive program and @ measures that were not rewarded by incentives .


Financial incentives for quality were consistently associated with higher performance for the incentivized measures -LSB- +@ percentage points at @ mo of exposure ( approximately +@ % ) , P < @ -RSB- and lower performance for the unincentivized measures -LSB- -@ percentage points at @ mo of exposure ( approximately -@ % ) , P < @ -RSB- .


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 @ 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 @ diabetes who were overweight but not obese .


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


Patients aged @-@ years with type @ diabetes and a BMI between @ and @ kg/m@ were randomly assigned ( @:@ ) , 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 @ years after randomisation , defined as glucose concentrations of less than @ mmol/L when fasting and less than @ mmol/L @ h after @ 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 ACTRN@ .


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


@ ( @ % ) participants in the multidisciplinary care plus gastric band group and two ( @ % ) participants in the multidisciplinary care only group achieved diabetes remission ( difference in proportions @ , @ % CI @-@ @ ; p = @ ) .


One ( @ % ) participant in the gastric band group needed revisional surgery and four others ( @ % ) 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 @ diabetes improves glycaemic control with an acceptable adverse event profile .


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


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 @ premature infants with feeding difficulties .


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


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


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


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 = @ ) .


The surgical subjects ( n = @ ) 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 @ volunteers from different age groups over @ 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 LX@ , a dual inhibitor of sodium-glucose cotransporter ( SGLT ) @ and SGLT@ , in type @ diabetes .


Type @ diabetic patients inadequately controlled on metformin were randomly assigned to @ mg once daily , @ mg once daily , @ mg twice daily , or @ mg once daily of LX@ or placebo .


Primary end point was A@C change from baseline to week @ .


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


Baseline characteristics in @ patients randomly assigned to LX@ or placebo in this @-week dose-ranging study were similar : mean age @ years , A@C @ % ( @ mmol/mol ) , BMI @ kg/m ( @ ) , and BP @/@ mmHg .


LX@ significantly reduced A@C to week @ in a dose-dependent manner by @ % ( @ mmol/mol ) , @ % ( @ mmol/mol ) , @ % ( @ mmol/mol ) , and @ % ( @ mmol/mol ) , respectively ( P < @ each ) , compared with @ % ( @ mmol/mol ) for placebo .


Greater A@C reductions were produced by @ mg once a day than @ mg once a day LX@ without higher urinary glucose excretion , suggesting a contribution of SGLT@ inhibition .


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


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


No hypoglycemia occurred .


Dual inhibition of SGLT@/SGLT@ with LX@ 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 @ 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 @ hours .


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


They were followed for @ days ( or until discharge ) while catheterized and for up to @ 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 -LSB- ITT -RSB- population ) .


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


In the ITT population , @ of @ ( @ % ) 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 = @ , log-rank test ) and a longer time to ABU in the evaluable population ( P = @ ) .


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


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


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


There were significant improvements for both groups in CEAP-C class ( HL + S @ vs. @ ; HL + EVLA @ vs. @ ) , VCSS ( HL + S @ vs. @ ; HL + EVLA @ vs. @ ) , and CIVIQ@ score ( HL + S @ vs. @ ; HL + EVLA @ vs. @ ) ( p < @ ) .


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


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


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 ) -LSB- median @ versus @ months ( hazard ratio , HR ) @ ( @ % confidence interval , CI , @-@ @ ) ; P < @ -RSB- 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 ( < @ years ) and elderly ( @ years ) patients in the AFFIRM population .


Statistics are presented by age group ( < @ years , @ 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 < @ years -LSB- median not yet reached versus @ months ; HR @ ( @ % CI @-@ @ ) , P < @ -RSB- and in patients @ years -LSB- median @ versus @ months ; HR @ ( @ % CI @-@ @ ) , P = @ -RSB- , respectively .


rPFS was similarly improved in both the younger -LSB- HR @ ( @ % CI @-@ @ ) , P < @ -RSB- and elderly patient cohorts -LSB- HR @ ( @ % CI @-@ @ ) , P < @ -RSB- 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 patients@ years in the rates of all grade peripheral edema ( @ % versus @ % ) , fatigue ( @ % versus @ % ) , and diarrhea ( @ % versus @ % ) .


The overall grade@ 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 < @ years and two patients @ years .


Enzalutamide significantly improves outcomes in both younger ( < @ years ) and elderly patients ( @ 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 @ diabetes and their overweight/obese adult daughters .


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


The @-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 T@ ( baseline ) and T@ ( @ weeks ) that assessed various demographic , social network involvement , and dietary variables .


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


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


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 @ patients ( @ men and @ women ) were randomly assigned who had an ICD for primary ( @ % ) or secondary ( @ % ) prevention to EX or usual care ( UC ) .


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


EX consisted of @ weeks of home walking for @ h/d , @ d/wk at @ % to @ % of heart rate reserve , followed by @ weeks of maintenance home walking for @ 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 @ years and mean ejection fraction of @ ; all were taking - blocker medications .


EX significantly increased peak oxygen consumption ( EX , @ mL/kg per minute ; UC , @ mL/kg per minute ; P = @ ) at @ weeks , which persisted during maintenance exercise at @ weeks ( EX , @ mL/kg per minute ; UC , @ mL/kg per minute ; P < @ ) .


ICD shocks were infrequent ( EX = @ versus UC = @ ) , 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 .


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 @ 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 .


@ participants received verum and @ 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 @ patients , @ patients were randomised to the case group and @ 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 @-@ 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 @ % and that in control group was @ % .


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


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


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


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


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


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


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


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


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


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


An @-week postdonation course of @mg 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 @ to @ mg/d plus clopidogrel @ mg/d ( A+C ) over warfarin therapy ( international normalized ratio @-@ ) in patients with ischemic stroke , transient ischemic attack , or peripheral embolism with plaque in the thoracic aorta > @ 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 @ month and then every @ months post randomization .


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


After a median follow-up of @ years , the primary end point occurred in @ % ( @/@ ) and @ % ( @/@ ) of patients on A+C and on warfarin , respectively ( log-rank , P = @ ) .


The adjusted hazard ratio was @ ( @ % confidence interval , @-@ @ ; P = @ ) .


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


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


Time in therapeutic range ( @ % of the time for international normalized ratio @-@ ) 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 .


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 @ to February @ .


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


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


All the patients had standardized post operative care .


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


Time required for complete healing was also noted .


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


Out of @ patients , @ patients ( @ in group A and @ 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 @ 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 @ , weight @ kg , maximum O@ uptake @ mLkg ( -@ ) min ( -@ ) , Wmax @ Wkg ( -@ ) ; mean SD ) were repeatedly subjected to a laboratory based standardized exercise protocol before and after @ weeks of astaxanthin ( @ mg/day ) , or placebo supplementation in a double-blind randomized manner .


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


The pre-supplementation cycling trial induced a significant rise of median cardiac troponin T concentrations from @ ( IQR @-@ @ ) to @ ng/L ( IQR @-@ @ ) , immediately post-exercise ( p < @ ) .


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


However , daily astaxanthin supplementation had no effect on exercise-induced cardiac troponin T release ( p = @ ) , 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 .


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 @ 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 @ days after surgery .


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


A @-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 @ patients ( @ males , @ females , mean age @ years ) had both mandibular third molars removed on @ separate occasions .


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


In addition , the correlation between the swelling VAS score and t was @ ( P = @ ) and @ ( P = @ ) 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 ( @ ) .


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 @ , 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 , @ in the CRD and @ 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 ( @min versus @min for TME ; P = @ ) .


More patients in the TME group had a primary defunctioning ileostomy ( @ of @ versus @ of @ for CRD ; P = @ ) .


Severe complications occurred more frequently in the TME group ( @ of @ versus @ of @ for CRD ) .


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


At @ 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 @ wk .


In a randomized , parallel-group trial , @ participants received @ g peanuts/d as @-g servings of @ different flavors ( n = @ ) or a single flavor ( n = @-@ / 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 ( -@ @ mm Hg compared with -@ @ mm Hg ) , cholesterol ( -@ @ mg/dL compared with +@ @ mg/dL ) , and triglycerides ( -@ @ mg/dL compared with +@ @ mg/dL ) ( n = @ , @ , and @ , respectively ; P < @ ) 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 ( @ @ kg ) compared with individual flavors alone ( @ @ kg ) ( P < @ ) , 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-@ score of at least @ ) who met criteria for major depression , dysthymia , or both ( Mini-International Neuropsychiatric Interview ) .


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


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


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


Participants were , on average , @ years old , @ % were nonwhite , and @ % had posttraumatic stress disorder .


Intervention ( n = @ ) compared with usual care ( n = @ ) patients had greater improvement in depressive symptoms at @ months ( P < @ ) and @ months ( P = @ ) .


The intervention group compared with usual care group had improved functioning over the course of @ months ( P < @ ) , were more likely to have at least @ % decrease in depressive symptoms at @ months ( relative risk -LSB- RR -RSB- @ , @ % confidence interval -LSB- CI -RSB- @-@ @ ) , greater likelihood of at least four specialty mental health visits ( @-month RR @ , @ % CI @-@ @ ; @-month RR @ , @ % CI @-@ @ ) , adequate dose of antidepressant ( @-month RR @ , @ % CI @-@ @ ; @-month RR @ , @ % CI @-@ @ ) , and greater satisfaction with care ( @-month RR @ , @ % CI @-@ @ ; @-month RR @ , @ % CI @-@ @ ) .


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


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


TDT @ , 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 @ in rosacea subtype @ .


Patients aged @-@ scoring @-@/@ for the primary and secondary features of the rosacea standard grading system ( RSGS ) were enrolled .


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


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 @ randomized patients , @ 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 @ in both groups ( -@ TDT @ vs. -@ vehicle ; P = @ ) .


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


Non-transient erythema improved significantly with TDT @ at Week @ ( -@ vs. -@ vehicle ; P = @ ) , with @ grade improvement in @ % of patients ( vs. @ % vehicle ; P = @ ) .


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


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 @ 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 , @,@ ( @ % ) patients received amiodarone at randomization .


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


More amiodarone-treated patients had a stroke or a systemic embolism ( @ % / year vs. @ % / year ; adjusted hazard ratio -LSB- HR -RSB- : @ , @ % confidence interval -LSB- CI -RSB- : @ to @ ; p = @ ) .


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 @ % / year versus @ % / year ( HR : @ , @ % CI : @ to @ ) , death of @ % / year versus @ % / year ( HR : @ , @ % CI : @ to @ ) , and major bleeding of @ % / year versus @ % / year ( HR : @ , @ % CI : @ to @ ) .


In patients who did not receive amiodarone , the stroke or systemic embolism rate was @ % / year versus @ % / year ( HR : @ , @ % CI : @ to @ ) , death was @ % / year versus @ % / year ( HR : @ , @ % CI : @ to @ ) , and major bleeding was @ % / year versus @ % / year ( HR : @ , @ % CI : @ to @ ) .


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 @ CPG patients of SDDHS were enrolled in this study ( including @ patients from First Affiliated Hospital of Nanjing University of Chinese Medicine , @ from First Affiliated Hospital of Nanjing Medical University , @ from Xinqiao Hospital of Third Military Medical University , @ from First Affiliated Hospital of Guangzhou University of Chinese Medicine , @ from First Affiliated Hospital of Soochow University , and @ from Wuxi Affiliated Hospital of Nanjing University of Chinese Medicine ) .


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


There were @ cases in the safety analysis set ( @ cases in the trial group vs @ cases in the control group ) , and @ cases in the full analysis set ( @ cases in the trial group vs @ cases in the control group ) .


All patients received basic treatment such as ACEI/ARB .


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


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


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


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


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


The biochemical indices were observed before and after treatment including @ 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 ( @ % vs @ % , P < @ ) .


Results of stratified comparison of UTP showed better efficacy in the trial group ( @-@ @ g/@ h , P < @ ) .


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


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 > @ ) .


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


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 @ % 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 ( @ ) 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 @ patients .


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


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


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


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


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 @ ng/dL or free testosterone levels less than @ pg/mL received a standardized transdermal estradiol regimen during the @-week run-in period and were randomized to receive weekly intramuscular injections of placebo or @ , @ , @ , or @ mg of testosterone enanthate for @ 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 @ , @ , @ , @ , and @ ng/dL in the placebo , @-mg , @-mg , @-mg , and @-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 @-mg group , but not in women in the lower-dose groups .


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


The frequency of androgenic adverse events was low .


Testosterone administration in hysterectomized women with or without oophorectomy for @ 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 ( @ % ) or intra-abdominal sepsis ( @ % ) were randomly allocated to the ABThera ( n = @ ) or Barker 's vacuum pack ( n = @ ) .


On study days @ , @ , @ , @ , and @ , blood and peritoneal fluid were collected .


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


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


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


There was also no significant intergroup difference in the plasma concentrations of IL-@ , -@ , -@ , or -@ p@ or tumor necrosis factor between these time points .


The cumulative incidence of primary fascial closure at @ days was similar between groups ( hazard ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


However , @-day mortality was improved in the ABThera group ( hazard ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


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 .


Type @ 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 @ diabetes , and report here our @-month results .


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


We used a computer generated randomisation sequence to randomly assign patients ( @:@ , with permuted-blocks of size three or six and stratified by study site ) to receive either @ 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 @ .


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 @-h area under the curve C-peptide response to mixed meal tolerance test from baseline to @ months .


Analyses were by intention to treat .


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


This study is registered with ClinicalTrials.gov , number NCT@ .


Between Sept @ , @ , and June @ , @ , we screened @ individuals , randomly allocating @ to ATG and @ 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 -@ pmol/mL ( @ % CI -@ to -@ ) and those in the placebo group had a mean change of -@ pmol/mL ( -@ to -@ ) in the placebo group ( p = @ ) .


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-@ and acute-phase proteins .


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


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


ATG-treated patients had @ grade @-@ adverse events , many associated with T-cell depletion , compared with @ 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 @ months later in patients with new-onset type @ 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 @ diabetes .


To determine the efficacy of single-dose albendazole ( @ 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 @ schoolchildren in @ schools and analysed for STH prevalence and intensity .


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


Of the @ children who were found positive with at least one STH infection , a random sample of @ 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 @ % ; ( @ % CI : @-@ ) ; for hookworm , with an ERR of @ % ; ( @ % CI : @-@ @ ) and , for Trichuris trichiura , with an ERR of @ % ; ( @ % CI : @-@ @ ) .


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 .


@ 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 @ 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 @ , @ , and @ hours after non-invasive respiratory support .


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


In addition , rates of failure of assisted ventilation ( respectively , @ % vs. @ % ) and the occurrence of apnea ( @ % vs. @ % ) were significantly ( p < @ ) 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 .


The occupational physician condition consisted of screening , feedback and referral to the occupational physician for screen-positive nurses .


The third condition included screening , feedback , and referral to e-mental health .


The study was designed as an economic evaluation alongside a pragmatic cluster randomised controlled trial with randomisation at hospital-ward level .


The study included @ nurses in one academic medical centre in the Netherlands .


Treatment response was defined as an improvement on the Nurses Work Functioning Questionnaire of at least @ % between baseline and follow-up .


Total per-participant costs encompassed intervention costs , direct medical and non-medical costs , and indirect costs stemming from lost productivity due to absenteeism and presenteeism .


All costs were indexed for the year @ .


At @ months follow-up , significant improvement in work functioning occurred in @ % , @ % and @ % of the participating nurses in the control condition , the occupational physician condition and the e-mental health condition , respectively .


In these conditions the total average annualised costs were @ , @ and @ per nurse .


The median incremental cost-effectiveness ratio for the occupational physician condition versus the control condition was dominant , suggesting cost savings of @ per treatment responder .


The incremental cost-effectiveness ratio for the e-mental health condition versus the control condition was estimated at @ ( added costs ) per treatment responder .


Sensitivity analyses attested to the robustness of these findings .


The occupational physician condition resulted in greater treatment responses for less costs relative to the control condition and can therefore be recommended .


The e-mental health condition produced less treatment response than the control condition and can not be recommended as an intervention to improve work functioning among nurses .


We have developed a new oral vaccine against enterotoxigenic Escherichia coli ( ETEC ) , which is the most common cause of bacterial diarrhea in children in developing countries and in travelers .


The vaccine was tested for safety and immunogenicity alone and together with double-mutant heat-labile toxin ( dmLT ) adjuvant in a double-blind , placebo-controlled Phase I study in @ Swedish adults .


The vaccine consists of four inactivated recombinant E. coli strains overexpressing the major ETEC colonization factors ( CFs ) CFA/I , CS@ , CS@ , and CS@ mixed with an LT B-subunit related toxoid , LCTBA .


Volunteers received two oral doses of vaccine alone , vaccine plus @ g or @ g dmLT or placebo .


Secretory IgA antibody responses in fecal samples and IgA responses in secretions from circulating intestine-derived antibody secreting cells were assessed as primary measures of vaccine immunogenicity .


The vaccine was safe and well tolerated ; adverse events were few and generally mild with no significant differences between subjects receiving placebo or vaccine with or without adjuvant .


As many as @ % of subjects receiving vaccine alone and @ % receiving vaccine plus @ g dmLT showed significant mucosal IgA responses to all five primary vaccine antigens and about @ % of all vaccinees responded to at least four of the antigens .


Subjects receiving vaccine plus @ g dmLT responded with significantly increased intestine-derived anti-CS@ responses compared to subjects receiving vaccine alone .


The vaccine was safe and broadly immunogenic .


dmLT further enhanced mucosal immune responses to CF antigens present in low amounts in the vaccine .


Based on these encouraging results , the vaccine will be tested for safety and immunogenicity in different age groups including infants in Bangladesh and for protective efficacy in travelers .


In the Action in Diabetes and Vascular Disease : Preterax and Diamicron Modified Release Controlled Evaluation ( ADVANCE ) factorial trial , the combination of perindopril and indapamide reduced mortality among patients with type @ diabetes , but intensive glucose control , targeting a glycated hemoglobin level of less than @ % , did not .


We now report results of the @-year post-trial follow-up .


We invited surviving participants , who had previously been assigned to perindopril-indapamide or placebo and to intensive or standard glucose control ( with the glucose-control comparison extending for an additional @ months ) , to participate in a post-trial follow-up evaluation .


The primary end points were death from any cause and major macrovascular events .


The baseline characteristics were similar among the @,@ patients who originally underwent randomization and the @ patients who participated in the post-trial follow-up for a median of @ years ( blood-pressure-lowering comparison ) or @ years ( glucose-control comparison ) .


Between-group differences in blood pressure and glycated hemoglobin levels during the trial were no longer evident by the first post-trial visit .


The reductions in the risk of death from any cause and of death from cardiovascular causes that had been observed in the group receiving active blood-pressure-lowering treatment during the trial were attenuated but significant at the end of the post-trial follow-up ; the hazard ratios were @ ( @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ) and @ ( @ % CI , @ to @ ; P = @ ) , respectively .


No differences were observed during follow-up in the risk of death from any cause or major macrovascular events between the intensive-glucose-control group and the standard-glucose-control group ; the hazard ratios were @ ( @ % CI , @ to @ ) and @ ( @ % CI , @ to @ ) , respectively .


The benefits with respect to mortality that had been observed among patients originally assigned to blood-pressure-lowering therapy were attenuated but still evident at the end of follow-up .


There was no evidence that intensive glucose control during the trial led to long-term benefits with respect to mortality or macrovascular events .


( Funded by the National Health and Medical Research Council of Australia and others ; ADVANCE-ON ClinicalTrials.gov number , NCT@ . )


To evaluate , posthoc , the relationship between serum total testosterone and response to therapy in a study of tadalafil once daily for erectile dysfunction ( ED ) .


Men were aged @ years , with @-month history of ED and partial prior response to on-demand ( PRN ) phosphodiesterase type @ inhibitor ( PDE@I ) therapy .


A @-week maximum-dose PRN PDE@I run-in was followed by a @-week nondrug washout period , then randomization to tadalafil @ mg titrated to @ mg or tadalafil @ mg ( pooled for analyses ) or placebo once daily for @ weeks .


Analyses compared endpoint efficacy results between low - ( < @ ng/dL ) vs normal-testosterone ( @ ng/dL ) level subgroups .


Improvements for tadalafil vs placebo were significant for the International Index of Erectile Function ( IIEF ) Erectile Function domain , Intercourse Satisfaction domain , Overall Satisfaction domain , and Question @ ( confidence in the ability to get and keep an erection ; all P < @ ) , and for the Sexual Encounter Profile Questions @-@ ( all P. @ ) .


Analysis of covariance modeling identified significant treatment-by-subgroup interactions for the IIEF-Overall Satisfaction domain and erection confidence question and Sexual Encounter Profile Question @ .


Comparing between tadalafil-treated testosterone subgroups , the IIEF-Erectile Function domain scores improved significantly more in men with normal vs low testosterone ( P = @ ) ; no other significant differences were identified for either placebo or tadalafil .


No significant differences in pre-existing conditions were observed between tadalafil and placebo within the normal - and low-testosterone subgroups .


In men with partial response to a PRN PDE@I , tadalafil @ mg once daily significantly improved ED and sexual function vs placebo irrespective of testosterone levels .


Meaning-focused coping may be at the core of adequate adjustment to life after cancer .


Cancer survivors who experience their life as meaningful are better adjusted , have better quality of life and psychological functioning .


Meaning-Centered Group Psychotherapy for Cancer Survivors ( MCGP-CS ) was designed to help patients to sustain or enhance a sense of meaning and purpose in their lives .


The aim of the proposed study is to evaluate the effectiveness and cost-effectiveness of MCGP-CS .


Survivors diagnosed with cancer in the last @ years and treated with curative intent , are recruited via several hospitals in the Netherlands .


After screening , @ survivors are randomly assigned to one of the three study arms : @ .


Meaning-Centered Group Psychotherapy ( MCGP-CS ) @ .


Supportive group psychotherapy ( SGP ) @ .


Care as usual ( CAU ) .


Baseline assessment takes place before randomisation , with follow up assessments post-intervention and at @ , @ and @ months follow-up .


Primary outcome is meaning making ( PMP , PTGI , SPWB ) .


Secondary outcome measures address quality of life ( EORTC-@ ) , anxiety and depression ( HADS ) , hopelessness ( BHS ) , optimism ( LOT-R ) , adjustment to cancer ( MAC ) , and costs ( TIC-P , EQ-@D , PRODISQ ) .


Meaning-focused coping is key to adjustment to life after cancer , however , there is a lack of evidence based psychological interventions in this area .


Many cancer survivors experience feelings of loneliness and alienation , and have a need for peer support , therefore a group method in particular , can be beneficial for sustaining or enhancing a sense of meaning .


If this MCGP-CS is effective for cancer survivors , it can be implemented in the practice of psycho-oncology care .


The current standard treatment for IgA nephropathy relies on steroid and/or immunosuppressive therapy and angiotensin converting enzyme inhibitors ( ACEI ) or angiotensin receptor blocker ( ARB ) .


This study examines the benefits and safety of combining valsartan with clopidogrel and leflunomide as a treatment for progressive IgA nephropathy .


Patients with primary IgA nephropathy , confirmed by renal biopsy , were recruited for this study .


Patients were separated into four groups ( n = @ each ) after @ months of run-in period of valsartan treatment .


All patients were treated with valsartan alone ( Group @ ) or valsartan and either clopidogrel ( Group @ ) or leflunomide ( Group @ ) or both clopidogrel and leflunomide ( Group @ ) .


Each group was followed up for their next @ months for @h urinary protein excretion , serum creatinine and estimated glomerular filtration rate ( eGFR ) to assess the effect of the treatment .


Adverse effects were recorded concurrently to evaluate the safety of the treatment .


Of all @ patients , @ were males and @ were females , with an average age of @ years .


Baseline characteristics were comparable among the four groups ( P > @ ) prior to the experimental treatment .


There was a significant ( P < @ ) decrease in @h urinary protein excretion after @ months of experimental treatment .


At the end of the @ months , groups @ and @ showed a respective @ % and @ % reduction in proteinuria .


The serum creatinine was significantly higher ( P < @ ) in group @ and @ at the end of the follow-up , and their respective eGFR was significantly lower .


The incidence of cardiovascular complication was @ % and @ % for group @ and @ , respectively .


The treatment with Valsartan combined with Clopidogrel and Leflunomide can reduce the urinary proteins loss and renal function deterioration for IgA nephropathy patients and cause minimal adverse reactions .


Our study suggests a new clinical treatment option for IgA nephropathy .


This study sought to examine the relationship between left ventricular mass ( LVM ) regression and clinical outcomes after transcatheter aortic valve replacement ( TAVR ) .


LVM regression after valve replacement for aortic stenosis is assumed to be a favorable effect of LV unloading , but its relationship to improved clinical outcomes is unclear .


Of @,@ patients with symptomatic aortic stenosis at high surgical risk receiving TAVR in the PARTNER ( Placement of Aortic Transcatheter Valves ) randomized trial or continued access registry , @ had both severe LV hypertrophy ( left ventricular mass index -LSB- LVMi -RSB- @ g/m ( @ ) men , @ g/m ( @ ) women ) at baseline and an LVMi measurement at @-day post-TAVR follow-up .


Clinical outcomes were compared for patients with greater than versus lesser than median percentage change in LVMi between baseline and @ days using Cox proportional hazard models to evaluate event rates from @ to @ days .


Compared with patients with lesser regression , patients with greater LVMi regression had a similar rate of all-cause mortality ( @ % vs. @ % , p = @ ) , but a lower rate of rehospitalization ( @ % vs. @ % , hazard ratio -LSB- HR -RSB- : @ , @ % confidence interval -LSB- CI -RSB- : @ to @ ; p = @ ) and a lower rate of rehospitalization specifically for heart failure ( @ % vs. @ % , p = @ ) .


The association with a lower rate of rehospitalization was consistent across subgroups and remained significant after multivariable adjustment ( HR : @ , @ % CI : @ to @ ; p = @ ) .


Patients with greater LVMi regression had lower B-type natriuretic peptide ( p = @ ) and a trend toward better quality of life ( p = @ ) at @-year follow-up than did those with lesser regression .


In high-risk patients with severe aortic stenosis and severe LV hypertrophy undergoing TAVR , those with greater early LVM regression had one-half the rate of rehospitalization over the subsequent year compared to those with lesser regression .


Percutaneous coronary interventions in patients with chronic kidney disease have shown suboptimal results .


Drug-eluting stents ( DES ) might reduce the rate of target vessel revascularization in comparison with bare-metal stents ( BMS ) in patients with chronic kidney disease .


However , given the multiple concomitant individual variables present in such patients , the comparison of neointimal growth after percutaneous coronary intervention is complex and difficult to assess .


Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient with Chronic Kidney Disease ( RENAL-DES ) was a prospective , randomized , multicenter study to directly compare the efficacy in the prevention of clinical restenosis of everolimus-eluting stent ( Xience V ) and BMS with an identical design ( Multi-Link Vision ) , both implanted in the same patient with multivessel coronary artery disease and chronic kidney disease ( estimated glomerular filtration rate < @ mL/min ) .


The primary end point of the study was the ischemia-driven target vessel revascularization as detected with myocardial scintigraphy at @ months .


In @ patients , @ coronary vessels were successfully treated with the randomly assigned DES ( n = @ ) or BMS ( n = @ ) .


At @ year , the rate of ischemia-driven target vessel revascularization for DES and BMS groups was @ % ( @ % confidence interval , @ % -@ % ) and @ % ( @ % confidence interval , @ % to @ % ) , respectively , P < @ .


For the multivariate analysis , independent predictors of the ischemia-driven target vessel revascularization were BMS implantation ( odds ratio , @ ; @ % confidence interval , @-@ @ ; P < @ ) and vessel size ( odds ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


This is the first randomized trial showing a reduction of clinical restenosis with a new-generation DES in comparison with a BMS of equal design , in patients who have chronic kidney disease with multivessel coronary artery disease .


Emergence agitation ( EA ) is frequently observed in children undergoing general anaesthesia .


This study tested whether the addition of an intra-operative low-dose infusion of dexmedetomidine to fentanyl treatment reduced the incidence of emergence delirium following desflurane anesthesia in children undergoing strabismus surgery .


A total of @ children ( @-@ years old ) undergoing strabismus surgery were enrolled .


Anaesthesia was induced with propofol and maintained with desflurane .


After induction , fentanyl ( @ g/kg ) was administered to all children .


During surgery , patients were infused with @ g / ( kgh ) dexmedetomidine ( Group FD , n = @ ) or normal saline ( Group F , n = @ ) .


Postoperative objective pain score ( OPS ) , Paediatric Agitation and Emergence Delirium ( PAED ) score , and EA score were documented every @ minutes in the post-anaesthesia care unit .


There were no significant differences between the two groups in demographic characteristics and haemodynamic changes .


The mean values of maximum EA , maximum PAED , and maximum OPS score were significantly lower in Group FD than in Group F at @ , @ , and @ minutes after arrival at the post-anaesthesia care unit ( p < @ ) .


The frequency of fentanyl rescue was lower in Group FD than in Group F ( p < @ ) .


The incidence of severe EA was significantly lower in Group FD than in Group F ( @ % vs. @ % , p < @ ) .


Intra-operative low-dose infusion of dexmedetomidine in addition to fentanyl reduces EA following desflurane anaesthesia in children undergoing strabismus surgeries .


To determine the effect of enclomiphene citrate in men with secondary hypogonadism .


Phase II clinical trial .


Community dwelling men making visits to physician offices .


Men with secondary hypogonadism .


Oral administration of enclomiphene citrate or @ % topical T gel .


Luteinizing hormone , FSH , T , and semen analysis .


Treatment with enclomiphene citrate resulted in increased morning serum T , E@ , and LH levels similar to those obtained with a topical T gel in men with secondary hypogonadism .


Follicle-stimulating hormone and LH were increased with enclomiphene , and sperm counts were conserved .


Enclomiphene citrate reverses the two hallmarks of secondary hypogonadism , namely , low serum total T and low or inappropriately normal LH while preserving sperm production .


Randomized prevention trial .


To compare the long-term effect of strengthening versus flexibility exercises and to evaluate the additional effect of abdominal bracing in recurrent low back pain ( LBP ) .


No conclusions could be made regarding appropriate exercise types or parameters in recurrent LBP .


Abdominal bracing increases trunk stiffness ; however , its long-term effect has not been evaluated in recurrent LBP yet .


Six hundred patients with recurrent LBP participated .


They were randomized into @ groups-@ patients ( age : @ @ ) performed strengthening exercises ; @ patients ( age : @ @ ) performed flexibility exercises ; @ patients ( age : @ @ ) performed strengthening exercises and used abdominal bracing in daily activities/exercises ; and @ patients ( age : @ @ ) performed flexibility exercises and used abdominal bracing in daily activities/exercises .


At the beginning of the study and at the end of @ consecutive years were recorded @ outcomes-frequency , intensity , and duration of pain , as well as frequency , intensity , and duration of exercises .


Regarding the first @ outcomes-all groups showed improvement from the beginning to the second year , but worsening from the second to the @th year ; there was no difference between strengthening and flexibility groups ; bracing groups showed better results versus nonbracing groups .


Intensity , frequency , and duration of the pain correlated with each other and with frequency of the exercises , but not with exercise duration or intensity .


The exercise frequency is more important than the type , duration , or intensity of the exercise .


Abdominal bracing adds to the exercise effect .


It could be considered as a `` preliminary muscle back belt on demand '' increasing the trunk stiffness and the frequency of the trunk muscle contractions/cocontractions without interruption of daily activities , which may remind/convince the patients to exercise more frequently .


Frequent exercising and bracing seems effective long-term prevention advices in recurrent LBP .


Methotrexate and infliximab are effective therapies for Crohn 's disease ( CD ) .


In the combination of maintenance methotrexate-infliximab trial , we evaluated the potential superiority of combination therapy over infliximab alone .


In a @-week , double-blind , placebo-controlled trial , we compared methotrexate and infliximab with infliximab alone in @ patients with CD who had initiated prednisone induction therapy ( @-@ mg/day ) within the preceding @ weeks .


Patients were assigned randomly to groups given methotrexate at an initial weekly dose of @ mg , escalating to @ mg/week ( n = @ ) , or placebo ( n = @ ) .


Both groups received infliximab ( @ mg/kg of body weight ) at weeks @ , @ , @ , and @ , and every @ weeks thereafter .


Prednisone was tapered , beginning at week @ , and discontinued no later than week @ .


The primary outcome was time to treatment failure , defined as a lack of prednisone-free remission ( CD Activity Index , < @ ) at week @ or failure to maintain remission through week @ .


Patients ' baseline characteristics were similar between groups .


By week @ , the actuarial rate of treatment failure was @ % in the combination therapy group compared with @ % in the infliximab monotherapy group ( P = @ ; hazard ratio , @ ; @ % confidence interval , @-@ @ ) .


Prespecified subgroup analyses failed to show a benefit in patients with short disease duration or an increased level of C-reactive protein .


No clinically meaningful differences were observed in secondary outcomes .


Combination therapy was well tolerated .


The combination of infliximab and methotrexate , although safe , was no more effective than infliximab alone in patients with CD receiving treatment with prednisone .


ClincialTrials.gov number , NCT@ .


Knee osteoarthritis ( OA ) is a mechanically driven disease , and it is suggested that medial tibiofemoral knee-joint load increases with pharmacologic pain relief , indicating that pharmacologic pain relief may be positively associated with disease progression .


Treatment modalities that can both relieve pain and reduce knee-joint load would be preferable .


The knee-joint load is influenced by functional alignment of the trunk , pelvis , and lower-limb segments with respect to the knee , as well as the ground-reaction force generated during movement .


Neuromuscular exercise can influence knee load and decrease knee pain .


It includes exercises to improve balance , muscle activation , functional alignment , and functional knee stability .


The primary objective of this randomized controlled trial ( RCT ) is to investigate the efficacy of a NEuroMuscular EXercise ( NEMEX ) therapy program , compared with optimized analgesics and antiinflammatory drug use , on the measures of knee-joint load in people with mild to moderate medial tibiofemoral knee osteoarthritis .


One hundred men and women with mild to moderate medial knee osteoarthritis will be recruited from general medical practices and randomly allocated ( @:@ ) to one of two @-week treatments , either ( a ) NEMEX therapy twice a week or ( b ) information on the recommended use of analgesics and antiinflammatory drugs ( acetaminophen and oral NSAIDs ) via a pamphlet and video materials .


The primary outcome is change in knee load during walking ( the Knee Index , a composite score of the first external peak total reaction moment on the knee joint from all three planes based on @D movement analysis ) after @ weeks of intervention .


Secondary outcomes include changes in the external peak knee-adduction moment and impulse and functional performance measures , in addition to changes in self-reported pain , function , health status , and quality of life .


These findings will help determine whether @ weeks of neuromuscular exercise is superior to optimized use of analgesics and antiinflammatory drugs regarding knee-joint load , pain and physical function in people with mild to moderate knee osteoarthritis .


This study evaluated the long-term effectiveness of multiple physical activity counseling strategies on subjective health among older adults .


Sedentary older adults ( n = @ ) were randomized to @ programs : ( @ ) a one-contact referral to locally organized physical activities , ( @ ) a one-contact provision of a walking program , ( @ ) a @-week multiple-contact physical activity coaching based on the Self-Determination Theory .


Self-reports on well-being , trait anxiety and physical activity were completed at baseline ( pretest ) , and @ weeks after ( @-week follow-up ) , @ year after ( @-year follow-up ) and @ years after ( @-year follow-up ) pretests .


All @ programs yielded improvements in well-being and trait anxiety from pretest to @-week follow-up and to @-year follow-up .


From pretest to @-year follow-up , no changes emerged in well-being whereas trait anxiety increased significantly .


Changes over time in well-being and anxiety were not significantly different between the programs .


Changes in physical activity contributed significantly to the prediction of changes in well-being and trait anxiety .


The findings demonstrate the year-round effectiveness of physical activity counseling on subjective health among older adults , irrespective of counseling strategy .


However , a relapse to baseline level occurred @ years after the intervention .


Physical activity appears to be an important determinant of older adults ' well-being .


Azathioprine ( AZA ) , a pro-drug metabolised to the active metabolites @-tioguanine nucleotides ( @TGN ) , is a steroid-sparing therapy for Crohn 's disease ( CD ) .


To investigate whether AZA therapy is optimised by individualised dosing based on thiopurine methyltransferase ( TPMT ) activity and @TGN concentrations .


This multicentre , double-blind , randomised controlled trial compared the efficacy and safety of weight-based vs. individualised AZA dosing in inducing and maintaining remission in adults and children with steroid-treated CD .


The primary outcome was clinical remission ( CR ) at @ weeks .


In the weight-based arm , subjects received @ mg/kg/day .


In the individualised dosing arm , the initial AZA dose was @ mg/kg/day ( if intermediate TPMT ) or @ mg/kg/day ( if normal TPMT ) .


Starting at week @ , the dose was adjusted to target @TGN concentrations of @-@ pmol/@ @ ( @ ) red blood cells ( RBC ) , or to a maximal dose of @ mg/kg/day .


After randomising @ subjects , the trial was stopped prematurely due to insufficient enrolment .


In intention-to-treat analysis , CR rates at week @ were @ % in the individualised arm vs. @ % in the weight-based arm ( P = @ ) .


In per-protocol ( PP ) analysis , week @ CR rates were @ % in the individualised arm and @ % in the weight-based arm ( P = @ ) .


At week @ , median @TGN concentrations in PP remitters and nonremitters were @ and @ pmol/@ @ ( @ ) RBC respectively ( P = @ ) .


Despite trends favouring individualised over weight-based AZA dosing , there were no statistically significant differences in efficacy , likely due to low statistical power and inability to achieve the target @TGN concentrations in the individualised arm .


-LSB- Clinicaltrials.Gov Identifier Nct@ -RSB- .


To evaluate the efficacy and feasibility of actions intended to implement or improve patients ' social network within the Italian National Health Service community mental health services .


We conducted a randomized clinical trial through a network of @ community mental health services on patients with a diagnosis in the schizophrenia spectrum ( F@ in the International Classification of Diseases , @th Revision ) , who were young ( aged younger than @ years ) , and with a poor social network ( less than @ relationships ) .


In addition to routine treatments , for the experimental group , the staff identified possible areas of interest for individual patients and proposed social activities taking place outside the services ' resources and with members of the community .


The main outcome was an improvement in the patients ' social network ; secondary end points were clinical outcome , abilities of daily living , and work .


One - and @-year outcomes of @ and @ , respectively , of the @ patients randomized were analyzed by intention-to-treat .