Healthy non-exposed subjects ( n = 10 ) received three titrated doses ( 2.5 g , 1.0 g and 0.1 g ) of MLSA-LAM ( n = 5 ) or MLCwA ( n = 5 ) and control antigens [ Rees MLSA ( 1.0 g ) and saline ] .


A randomized double blind Phase II safety and efficacy trial followed in an endemic region for leprosy ( Nepal ) , but involved only the 1.0 g ( high dose ) and 0.1 g ( low dose ) of each antigen ; Tuberculin PPD served as a control antigen .


This Phase II safety and efficacy trial consisted of three Stages : Stage A and B studies were an expansion of Phase I involving 10 and 90 subjects respectively , and Stage C was then conducted in two parts ( high dose and low dose ) , each enrolling 80 participants : 20 borderline lepromatous/lepromatous ( BL/LL ) leprosy patients , 20 borderline tuberculoid/tuberculoid ( BT/TT ) leprosy patients , 20 household contacts of leprosy patients ( HC ) , and 20 tuberculosis ( TB ) patients .


The primary outcome measure for the skin test was delayed type hypersensitivity induration .


In the small Phase I safety trial , reactions were primarily against the 2.5 g dose of both antigens and Rees control antigen , which were then excluded from subsequent studies .


In the Phase II , Stage A/B ramped-up safety study , 26 % of subjects ( 13 of 50 ) showed induration against the high dose of each antigen , and 4 % ( 2 of 50 ) reacted to the low dose of MLSA-LAM .


Phase II , Stage C safety and initial efficacy trial showed that both antigens at the low dose exhibited low sensitivity at 20 % and 25 % in BT/TT leprosy patients , but high specificity at 100 % and 95 % compared to TB patients .


The high dose of both antigens showed lower specificity ( 70 % and 60 % ) and sensitivity ( 10 % and 15 % ) .


BL/LL leprosy patients were anergic to the leprosy antigens .


MLSA-LAM and MLCwA at both high ( 1.0 g ) and low ( 0.1 g ) doses were found to be safe for use in humans without known exposure to leprosy and in target populations .


At a sensitivity rate of 20-25 % these antigens are not suitable as a skin test for the detection of the early stages of leprosy infection ; however , the degree of specificity is impressive given the presence of cross-reactive antigens in these complex native M. leprae preparations .


ClinicalTrails.gov NCT01920750 ( Phase I ) , NCT00128193 ( Phase II ) .


Recurrence and toxicity occur commonly among patients with rectal cancer who are treated with 5-fluorouracil ( 5-FU ) .


The authors hypothesized that genetic variation in folate-metabolizing genes could play a role in interindividual variability .


The objective of the current study was to evaluate the associations between genetic variants in folate-metabolizing genes and clinical outcomes among patients with rectal cancer treated with 5-FU .


The authors investigated 8 functionally significant polymorphisms in 6 genes ( methylenetetrahydrofolate reductase [ MTHFR ] [ C677T , A1298C ] , SLC19A1 [ G80A ] , SHMT1 [ C1420T ] , dihydrofolate reductase [ DHFR ] [ Del19bp ] , TS 1494del , and TSER ) involved in folate metabolism in 745 patients with TNM stage II or III rectal cancer enrolled in a phase 3 adjuvant clinical trial of 3 regimens of 5-FU and radiotherapy ( INT-0144 and SWOG 9304 ) .


There were no statistically significant associations noted between polymorphisms in any of the genes and overall survival , disease-free survival ( DFS ) , and toxicity in the overall analyses .


Nevertheless , there was a trend toward worse DFS among patients with the variant allele of MTHFR C677T compared with wild-type , particularly in treatment arm 2 , in which patients with the MTHFR C677T TT genotype had worse overall survival ( hazards ratio , 1.76 ; 95 % confidence interval , 1.06-2 .93 [ P = .03 ] ) and DFS ( hazards ratio , 1.84 ; 95 % confidence interval , 1.12-3 .03 [ P = .02 ] ) compared with those with homozygous wild-type .


In addition , there was a trend toward reduced hematological toxicity among patients with variants of SLC19A1 G80A in treatment arm 1 ( P for trend , .06 ) and reduced esophagitis/stomatitis noted among patients with variants of TSER in treatment arm 3 ( P for trend , .06 ) .


Genetic variability in folate-metabolizing enzymes was found to be associated only to a limited degree with clinical outcomes among patients with rectal cancer treated with 5-FU .


Pelvic organ prolapse is common and is strongly associated with childbirth and increasing age .


Women with prolapse are often advised to do pelvic floor muscle exercises , but evidence supporting the benefits of such exercises is scarce .


We aimed to establish the effectiveness of one-to-one individualised pelvic floor muscle training for reducing prolapse symptoms .


We did a parallel-group , multicentre , randomised controlled trial at 23 centres in the UK , one in New Zealand , and one in Australia , between June 22 , 2007 , and April 9 , 2010 .


Female outpatients with newly-diagnosed , symptomatic stage I , II , or III prolapse were randomly assigned ( 1:1 ) , by remote computer allocation with minimsation , to receive an individualised programme of pelvic floor muscle training or a prolapse lifestyle advice leaflet and no muscle training ( control group ) .


Outcome assessors , and investigators who were gynaecologists at trial sites , were masked to group allocation ; the statistician was masked until after data analysis .


Our primary endpoint was participants ' self-report of prolapse symptoms at 12 months .


Analysis was by intention-to-treat analysis .


This trial is registered , number ISRCTN35911035 .


447 eligible patients were randomised to the intervention group ( n = 225 ) or the control group ( n = 222 ) .


377 ( 84 % ) participants completed follow-up for questionnaires at 6 months and 295 ( 66 % ) for questionnaires at 12 months .


Women in the intervention group reported fewer prolapse symptoms ( ie , a significantly greater reduction in the pelvic organ prolapse symptom score [ POP-SS ] ) at 12 months than those in the control group ( mean reduction in POP-SS from baseline 3.77 [ SD 5.62 ] vs 2.09 [ 5.39 ] ; adjusted difference 1.52 , 95 % CI 0.46-2 .59 ; p = 0.0053 ) .


Findings were robust to missing data .


Eight adverse events ( six vaginal symptoms , one case of back pain , and one case of abdominal pain ) and one unexpected serious adverse event , all in women from the intervention group , were regarded as unrelated to the intervention or to participation in the study .


One-to-one pelvic floor muscle training for prolapse is effective for improvement of prolapse symptoms .


Long-term benefits should be investigated , as should the effects in specific subgroups .


Chief Scientist Office of the Scottish Government Health and Social Care Directorates , New Zealand Lottery Board , and National Health and Medical Research Council ( Australia ) .


To compare the efficacy of the Newcastle infant dialysis and ultrafiltration system ( Nidus ) with peritoneal dialysis ( PD ) and conventional haemodialysis ( HD ) in infants weighing < 8 kg .


We compared the urea , creatinine and phosphate clearances , the ultrafiltration precision , and the safety of the Nidus machine with PD in 7 piglets weighing 1-8 kg , in a planned randomised cross-over trial in babies , and in babies for whom no other therapy existed , some of whom later graduated to conventional HD .


Two babies entered the randomised trial ; 1 recovered rapidly on PD , the other remained on the Nidus as PD failed .


Additionally , 9 babies were treated on the Nidus on humanitarian grounds : 3 because of failed PD , and 3 with permanent kidney failure later converted to conventional HD .


We haemodialysed 10 babies weighing between 1.8 and 5.9 kg for 2,475 h during 354 Nidus sessions without any clinically important incidents , and without detectable haemolysis .


Single-lumen vascular access was used with no blood priming of circuits .


The urea , creatinine and phosphate clearances using the Nidus were around 1.5 to 2.0 ml/min in piglets and babies , and were consistently higher than PD clearances , which ranged from about 0.2 to 0.8 ml/min ( p0 .0002 for each chemical ) .


Ultrafiltration was achieved to microlitre precision by the Nidus , but varied widely with PD .


Fluid removal using conventional HD was imprecise and resulted in some hypovolaemic episodes requiring correction .


The Nidus can provide HD in the Pediatric Intensive Care Unit ( PICU ) and outpatient intermittent HD without blood priming for babies weighing < 8 kg , It generates higher dialysis clearances than PD , and delivers more precise ultrafiltration control than either PD or conventional HD .


To evaluate the effects of canagliflozin on plasma volume , urinary glucose excretion ( UGE ) , fasting plasma glucose ( FPG ) , glycated haemoglobin ( HbA1c ) and additional measures of fluid/electrolyte balance in patients with type 2 diabetes on background therapy with metformin and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers .


Patients ( N = 36 ) were randomized ( 1:1 ) to receive canagliflozin 300 mg or placebo for 12 weeks .


Pharmacodynamic parameters were assessed at baseline and at weeks 1 and 12 .


Increased 24-h UGE was seen in the canagliflozin group compared with a reduction in the placebo group at both week 1 ( 91.8 vs. -2.4 g ) and week 12 ( 82.6 vs. -0.4 g ) .


Canagliflozin also reduced both FPG and HbA1c .


Reductions in body weight and blood pressure were observed at weeks 1 and 12 .


Canagliflozin decreased plasma volume compared with an increase with placebo at week 1 ( -5.4 vs. 4.3 % ; p = 0.02 ) , but this was largely attenuated at week 12 ( 4.6 vs. 5.8 % ; p = 0.76 ) .


A modest numerical increase in urine volume was observed with canagliflozin at week 1 that was attenuated at week 12 ; other measures of volume status ( i.e. blood urea nitrogen , serum creatinine and haematocrit ) remained modestly increased with canagliflozin at week 12 .


Canagliflozin provided sustained effects on UGE and FPG over 12 weeks and a transient reduction in plasma volume that was largely attenuated by week 12 .


Androgen-deprivation therapy ( ADT ) has been the backbone of treatment for metastatic prostate cancer since the 1940s .


We assessed whether concomitant treatment with ADT plus docetaxel would result in longer overall survival than that with ADT alone .


We assigned men with metastatic , hormone-sensitive prostate cancer to receive either ADT plus docetaxel ( at a dose of 75 mg per square meter of body-surface area every 3 weeks for six cycles ) or ADT alone .


The primary objective was to test the hypothesis that the median overall survival would be 33.3 % longer among patients receiving docetaxel added to ADT early during therapy than among patients receiving ADT alone .


A total of 790 patients ( median age , 63 years ) underwent randomization .


After a median follow-up of 28.9 months , the median overall survival was 13.6 months longer with ADT plus docetaxel ( combination therapy ) than with ADT alone ( 57.6 months vs. 44.0 months ; hazard ratio for death in the combination group , 0.61 ; 95 % confidence interval [ CI ] , 0.47 to 0.80 ; P < 0.001 ) .


The median time to biochemical , symptomatic , or radiographic progression was 20.2 months in the combination group , as compared with 11.7 months in the ADT-alone group ( hazard ratio , 0.61 ; 95 % CI , 0.51 to 0.72 ; P < 0.001 ) .


The rate of a prostate-specific antigen level of less than 0.2 ng per milliliter at 12 months was 27.7 % in the combination group versus 16.8 % in the ADT-alone group ( P < 0.001 ) .


In the combination group , the rate of grade 3 or 4 febrile neutropenia was 6.2 % , the rate of grade 3 or 4 infection with neutropenia was 2.3 % , and the rate of grade 3 sensory neuropathy and of grade 3 motor neuropathy was 0.5 % .


Six cycles of docetaxel at the beginning of ADT for metastatic prostate cancer resulted in significantly longer overall survival than that with ADT alone .


( Funded by the National Cancer Institute and others ; ClinicalTrials.gov number , NCT00309985 . )


The aim of this study was to evaluate the haemodynamic effects of serelaxin ( 30 g/kg/day 20-h infusion and 4-h post-infusion period ) in patients with acute heart failure ( AHF ) .


This double-blind , multicentre study randomized 71 AHF patients with pulmonary capillary wedge pressure ( PCWP ) 18 mmHg , systolic blood pressure ( BP ) 115 mmHg , and estimated glomerular filtration rate 30 mL/min/1 .73 m ( 2 ) to serelaxin ( n = 34 ) or placebo ( n = 37 ) within 48 h of hospitalization .


Co-primary endpoints were peak change from baseline in PCWP and cardiac index ( CI ) during the first 8 h of infusion .


Among 63 patients eligible for haemodynamic analysis ( serelaxin , n = 32 ; placebo , n = 31 ) , those treated with serelaxin had a significantly higher decrease in peak PCWP during the first 8 h of infusion ( difference vs. placebo : -2.44 mmHg , P = 0.004 ) .


Serelaxin showed no significant effect on the peak change in CI vs. placebo .


Among secondary haemodynamic endpoints , a highly significant reduction in pulmonary artery pressure ( PAP ) was observed throughout the serelaxin infusion ( largest difference in mean PAP vs. placebo : -5.17 mmHg at 4 h , P < 0.0001 ) .


Right atrial pressure , systemic/pulmonary vascular resistance , and systolic/diastolic BP decreased from baseline with serelaxin vs. placebo and treatment differences reached statistical significance at some time points .


Serelaxin administration improved renal function and decreased N-terminal pro-brain natriuretic peptide levels vs. placebo .


Treatment with serelaxin was well tolerated with no apparent safety concerns .


The haemodynamic effects of serelaxin observed in the present study provide plausible mechanistic support for improvement in signs and symptoms of congestion observed with this agent in AHF patients .


ClinicalTrials.gov identifier NCT01543854 .


Quetiapine is an atypical antipsychotic with demonstrated efficacy in the treatment of adolescent schizophrenia and pediatric bipolar mania .


Large , placebo-controlled studies of interventions in pediatric bipolar depression are lacking .


The current study investigated the efficacy and safety of quetiapine extended-release ( XR ) in patients 10-17 years of age , with acute bipolar depression .


This multicenter , double-blind , randomized , placebo-controlled study investigated quetiapine XR ( dose range , 150-300mg / day ) in pediatric outpatients with an American Psychiatric Association , Diagnostic and Statistical Manual of Mental Disorders , 4th ed. , Text Revision ( DSM-IV-TR ) diagnosis of bipolar I or bipolar II disorder ( current or most recent episode depressed ) treated for up to 8 weeks ( ClinicalTrials.gov identifier : NCT00811473 ) .


The primary study outcome was mean change in Children 's Depression Rating Scale-Revised ( CDRS-R ) total score .


Secondary efficacy outcomes included CDRS-R-based response and remission rates .


Of 193 patients randomized to treatment , 144 patients completed the study ( 75.3 % of quetiapine XR group [ n = 70 ] ; 74.0 % of placebo group [ n = 74 ] ) .


Least squares mean changes in CDRS-R total score at week 8 were : -29.6 ( SE , 1.65 ) with quetiapine XR and -27.3 ( SE , 1.60 ) with placebo , a between-treatment group difference of -2.29 ( SE , 1.99 ; 95 % CI , -6.22 , 1.65 ; p = 0.25 ; mixed-model for repeated measures analysis ) .


Rates of response and remission did not differ significantly between treatment groups .


The safety profile of quetiapine XR was broadly consistent with the profile reported previously in adult studies of quetiapine XR and pediatric studies of quetiapine immediate-release ( IR ) .


Potentially clinically significant elevations in clinical chemistry values included triglycerides ( 9.3 % , quetiapine XR ; 1.4 % , placebo group ) and thyroid stimulating hormone ( 4.7 % , quetiapine XR ; 0 % , placebo group ) .


An adverse event potentially related to diabetes mellitus occurred in 3.3 % of the quetiapine XR versus no adverse events in the placebo group .


Quetiapine XR did not demonstrate efficacy relative to placebo in this 8 week study of pediatric bipolar depression .


Quetiapine XR was generally safe and well tolerated .


Patients who adhere to medications experience better outcomes than their nonadherent counterparts .


However , these observations may be confounded by patient behaviors .


The level of adherence necessary for patients to derive benefit and whether adherence to all agents is important for diseases that require multiple drugs remain unclear .


This study quantifies the relationship between medication adherence and post-myocardial infarction ( MI ) adverse coronary events .


This is a secondary analysis of the randomized MI FREEE trial .


Patients who received full prescription coverage were classified as adherent ( proportion of days covered 80 % ) or not based upon achieved adherence in the 6 months after randomization .


First major vascular event or revascularization rates were compared using multivariable Cox models adjusting for comorbidity and health-seeking behavior .


Compared with patients randomized to usual care , full coverage patients adherent to statin , - blocker , or angiotensin-converting enzyme inhibitor/angiotensin receptor blocker were significantly less likely to experience the study 's primary outcome ( hazard ratio [ HR ] range 0.64-0 .81 ) .


In contrast , nonadherent patients derived no benefit ( HR range 0.98-1 .04 , P .01 for the difference in HRs between adherent and nonadherent patients ) .


Partially adherent patients had no reduction in clinical outcomes for any of the drugs evaluated , although their achieved adherence was higher than that among controls .


Achieving high levels of adherence to each and all guideline-recommended post-MI secondary prevention medication is associated with improved event-free survival .


Lower levels of adherence appear less protective .


To evaluate whether ramosetron increases the corrected QT ( QTc ) interval .


Prospective , randomized , controlled study .


Operating room .


135 patients undergoing elective laparoscopic cholecystectomy .


Patients were allocated to three groups to receive ondansetron 4 mg ( Group O4 ) , ramosetron 0.3 mg ( Group R ) , or ondansetron 8 mg ( Group O8 ) .


The study drugs were administered intravenously approximately 15 minutes before the end of surgery .


The QT interval for 10 minutes after administration was recorded .


The QTc interval was calculated according to the Fridericia ( QTcF ) formula .


The primary outcome was the QTcF interval among the three groups during the 10 minutes after administration of the study drugs .


The QTcF interval was not significantly prolonged after administration of ondansetron 4 mg and ramosetron .


It was significantly increased from one minute after administration until 7 minutes after ondansetron 8 mg ( Group O8 ) .


The QTcF interval was significantly longer in Group O8 at 1 , 2 , 3 , 4 , and 5 minutes .


The prophylactic administration 0.3 mg of ramosetron does not increase the QTc interval .


Ondansetron 8 mg increases the QTc interval more so than 4 mg of ondansetron .


To determine whether mechanical cleaning with interdental brushes combined with the use of cetylpyridinium chloride ( 0.3 % CPC ) gel was more effective at plaque control than mechanical cleaning with interdental brushes alone .


Forty individuals ( 30-70 years old ) with at least 20 teeth and moderate chronic periodontitis who had no experience with interdental cleaning aids were randomly assigned to a treatment group ( brush + gel , n = 20 ) or a control group ( brush , n = 20 ) .


Both groups were examined by a dentist at baseline and at 3 and 6 months for changes in interdental plaque ( interproximal plaque index [ API ] ) levels , gingival inflammation ( sulcus bleeding index [ SBI ] ) , probing depth ( PD ) and bleeding on probing ( BOP ) .


No baseline differences in age , gender or number of teeth were observed between the two groups .


During the study period , improvements in API and BOP were comparable between groups .


However , improvements in SBI and PD were significantly greater in the test group than in the control group ( p = 0.046 and p = 0.029 , respectively ) .


Mechanical interdental plaque control using interdental brushes combined with the use of CPC gel significantly improved 6-month gingival and periodontal outcomes ( SBI and PD ) compared with mechanical cleaning with interdental brushes alone .


Nicotine patches have been reliably demonstrated to improve smoking cessation outcomes but most users still lapse , and then relapse , during treatment .


While patch has been shown to alleviate background cravings , its effects on cue-induced cravings - which have been linked to the occurrence of lapse events - are poorly understood .


Here we investigate the effect of nicotine patch on the intensity of craving and negative affect experienced during the hours immediately preceding lapse episodes .


Participants were 185 smokers who had quit in the context of a randomized , double-blind trial of high-dose ( 35mg ) nicotine patch and who lapsed at least once during the first 5 weeks of treatment .


Participants used electronic diaries to monitor their smoking , affect , and craving during their cessation attempt .


The data suggest that developments on the lapse day - either external events or changes in internal states - caused craving and negative affect to rise , cumulating in the lapse .


Nicotine is known to lower background craving and negative affect , but the difference between patch and placebo appeared to dissipate in the hours immediately preceding lapse episodes .


Understanding the process by which these symptoms `` spike '' prior to a lapse - and developing treatments to counter it - are worthy research endeavors .


This randomized double-blind study was designed to determine if respiratory muscle weakness - measured by maximum inspiratory pressure ( MIP ) , maximum expiratory pressure ( MEP ) , forced vital capacity ( FVC ) , and forced expiratory volume in one second ( FEV1 ) - persists even if an acceleromyographic train-of-four ratio ( TOFR ) of 1.0 is reached after major abdominal surgery .


Twenty patients underwent respiratory function tests before induction of anesthesia .


Rocuronium was given , and the tests were repeated after extubation when the TOFR reached 1.0 .


The patients were then randomized to receive sugammadex 1 mgkg ( -1 ) or placebo , and the same tests were repeated five and 20 min later .


Between-group comparisons were carried out with a mixed-model analysis of variance analysis .


After anesthesia and adequate epidural analgesia , MIP and MEP decreased by 60 % in both groups .


In the placebo group , MIP decreased from a pre-induction value ( median [ range ] ) of 61.8 [ 31.3-96 .1 ] to 19.6 [ 8.3-58 .3 ] cm H2O after extubation without significant variation five and 20 min after placebo .


In the sugammadex group , MIP decreased from a pre-induction value of 57.8 [ 13.0-96 .4 ] to 20.5 [ 6.4-67 .3 ] cm H2O after extubation .


No differences were recorded after sugammadex administration ( P = 0.246 between groups ) .


In the placebo group , MEP decreased from 88.8 [ 65.1-120 .3 ] before induction to 37.6 [ 13.4-70 .6 ] cm H2O after extubation .


In the sugammadex group , MEP decreased from 85.5 [ 58.6-132 .7 ] to 30.8 [ 10.5-60 .5 ] cm H2O , with no improvement five and 20 min after either placebo or sugammadex administration ( P = 0.648 ) .


Similarly , the FCV and FEV1 decreased 30-40 % after extubation in both study groups .


Acceleromyographic TOFR of 1.0 excludes residual neuromuscular paralysis .


However , major respiratory dysfunction is observed after abdominal surgery .


This trial was registered at ClinicalTrials.gov : NCT01503840 .


To compare the rates of neonatal morbidity and cerebral palsy among preterm neonates ( less than 37 weeks of gestation ) delivered by cesarean for a nonreassuring fetal heart rate ( FHR ) tracing compared with those who did not .


This was a secondary analysis of a multicenter randomized trial of MgSO4 for the prevention of cerebral palsy .


Newborns of women delivered by cesarean delivery for nonreassuring FHR were compared with a control group composed of the offspring of women who labored for 2 hours or longer but did not undergo cesarean delivery for nonreassuring FHR regardless of the mode of delivery .


Using multivariable analysis to adjust for potential confounders , our objective was to compare two outcomes : 1 ) composite neonatal morbidity ( Apgar score 3 or less at 5 minutes , seizure , sepsis , necrotizing enterocolitis grade II or III , intraventricular hemorrhage grade III or IV , or death before discharge ) and 2 ) neurologic injury ( cerebral palsy ) at 2 years or more of corrected age between the groups .


Of the 1,291 preterm neonates who met the inclusion criteria , 177 ( 14 % ) were delivered by cesarean for nonreassuring FHR compared with 1,114 ( 86 % ) in the control group .


Composite neonatal morbidity was similar between the groups ( 30.5 compared with 22.2 % , adjusted odds ratio [ OR ] 1.4 , 95 % confidence interval [ CI ] 0.9-2 .1 ) .


The rate of cerebral palsy of any severity ( 8.3 compared with 4.0 % , adjusted OR 2.3 , 95 % CI 1.2-4 .5 ) and moderate-to-severe cerebral palsy at 2 years of corrected age ( 6.0 compared with 2.2 % , adjusted OR 3.2 , 95 % CI 1.4-7 .1 ) was significantly higher in children born through cesarean delivery for nonreassuring FHR .


Nonreassuring fetal tracing deemed so serious as to require cesarean delivery is associated with an increased risk of cerebral palsy in preterm neonates .


II .


Concerns that general health checks , including screening for risk factors to ischemic heart disease ( IHD ) , have negative psychological consequences seem widely unfounded ; however , previous studies are only based on self-reports from participants .


To investigate if risk factor screening in healthy adults leads to mental distress in the study population , independent of participation .


The Inter99 study ( 1999 - 2006 ) was a randomised intervention in the general population , aiming to prevent IHD by a healthier lifestyle .


We included the whole study population , independent of participation ( n = 60,915 ) .


We merged data with information on the use of psychotropic medication and/or hospitalisation due to psychiatric diagnoses , as retrieved from national registers in Denmark , 4 years before and 5 years after the study began .


We conducted analyses using generalised estimating equations .


There was no significant difference between the intervention and control groups in their use of antipsychotics , hypnotics/sedatives , antidepressants or anxiolytics .


As regards admission to the hospital with mental disorders , no significant difference was seen .


These findings were true based on a yearly basis , and when investigating both short-term and a long-term effects of the intervention .


There was no interaction with socioeconomic status .


Of the 918 persons with a psychiatric diagnosis before the study start , 303 ( 33 % ) were re-admitted in the intervention period .


Pre-screening of psychological status did not influence the psychological impact of screening .


This large , randomised intervention study supports that screening for risk factors to IHD does not increase mental distress , not even in the mentally or socioeconomically most vulnerable persons .


This study included the whole Inter99 study population not only study participants .


Postoperative pain is an important adverse event following inguinal hernia repair .


The aim of this trial was to compare postoperative pain within the first 3 months and 1 year after surgery in patients undergoing open mesh inguinal hernia repair using either a self-gripping lightweight polyester mesh or a polypropylene lightweight mesh fixed with sutures .


Adult men undergoing Lichtenstein repair for primary inguinal hernia were randomized to ProGrip self-gripping mesh or standard sutured lightweight polypropylene mesh .


In total 557 men were included in the final analysis ( self-gripping mesh 270 , sutured mesh 287 ) .


Early postoperative pain scores were lower with self-gripping mesh than with sutured lightweight mesh : mean visual analogue pain score relative to baseline +13 and +86 respectively at discharge ( P = 0033 ) , and mean surgical pain scale score relative to baseline +42 and +97 respectively on day 7 ( P = 0027 ) .


There was no significant difference in mid-term ( 1month ) and long-term ( 3months and 1 year ) pain scores between the groups .


Surgery was significantly quicker with self-gripping mesh ( mean difference 76min ; P < 0001 ) .


There were no significant differences in reported mesh handling , analgesic consumption , other wound complications , patient satisfaction or hernia recurrence between the groups .


Self-gripping mesh for open inguinal hernia repair was well tolerated and reduced early postoperative pain ( within the first week ) , without increasing the risk of early recurrence .


It did not reduce chronic pain .


NCT00827944 ( http://www.clinicaltrials.gov ) .


Older adults are frequently hospitalized from the emergency department ( ED ) after an episode of unexplained syncope .


Current admission patterns are costly , with little evidence of benefit .


We hypothesize that an ED observation syncope protocol will reduce resource use without adversely affecting patient-oriented outcomes .


This randomized trial at 5 EDs compared an ED observation syncope protocol to inpatient admission for intermediate-risk adults ( 50 years ) presenting with syncope or near syncope .


Primary outcomes included inpatient admission rate and length of stay .


Secondary outcomes included 30-day and 6-month serious outcomes after hospital discharge , index and 30-day hospital costs , 30-day quality-of-life scores , and 30-day patient satisfaction .


Study staff randomized 124 patients .


Observation resulted in a lower inpatient admission rate ( 15 % versus 92 % ; 95 % confidence interval [ CI ] difference -88 % to -66 % ) and shorter hospital length of stay ( 29 versus 47 hours ; 95 % CI difference -28 to -8 ) .


Serious outcome rates after hospital discharge were similar for observation versus admission at 30 days ( 3 % versus 0 % ; 95 % CI difference -1 % to 8 % ) and 6 months ( 8 % versus 10 % ; 95 % CI difference -13 % to 9 % ) .


Index hospital costs in the observation group were $ 629 ( 95 % CI difference - $ 1,376 to - $ 56 ) lower than in the admission group .


There were no differences in 30-day quality-of-life scores or in patient satisfaction .


An ED observation syncope protocol reduced the primary outcomes of admission rate and hospital length of stay .


Analyses of secondary outcomes suggest reduction in index hospital costs , with no difference in safety events , quality of life , or patient satisfaction .


Our findings suggest that an ED observation syncope protocol can be replicated and safely reduce resource use .


Elevated lipoprotein-associated phospholipase A2 activity promotes the development of vulnerable atherosclerotic plaques , and elevated plasma levels of this enzyme are associated with an increased risk of coronary events .


Darapladib is a selective oral inhibitor of lipoprotein-associated phospholipase A2 .


In a double-blind trial , we randomly assigned 15,828 patients with stable coronary heart disease to receive either once-daily darapladib ( at a dose of 160 mg ) or placebo .


The primary end point was a composite of cardiovascular death , myocardial infarction , or stroke .


Secondary end points included the components of the primary end point as well as major coronary events ( death from coronary heart disease , myocardial infarction , or urgent coronary revascularization for myocardial ischemia ) and total coronary events ( death from coronary heart disease , myocardial infarction , hospitalization for unstable angina , or any coronary revascularization ) .


During a median follow-up period of 3.7 years , the primary end point occurred in 769 of 7924 patients ( 9.7 % ) in the darapladib group and 819 of 7904 patients ( 10.4 % ) in the placebo group ( hazard ratio in the darapladib group , 0.94 ; 95 % confidence interval [ CI ] , 0.85 to 1.03 ; P = 0.20 ) .


There were also no significant between-group differences in the rates of the individual components of the primary end point or in all-cause mortality .


Darapladib , as compared with placebo , reduced the rate of major coronary events ( 9.3 % vs. 10.3 % ; hazard ratio , 0.90 ; 95 % CI , 0.82 to 1.00 ; P = 0.045 ) and total coronary events ( 14.6 % vs. 16.1 % ; hazard ratio , 0.91 ; 95 % CI , 0.84 to 0.98 ; P = 0.02 ) .


In patients with stable coronary heart disease , darapladib did not significantly reduce the risk of the primary composite end point of cardiovascular death , myocardial infarction , or stroke .


( Funded by GlaxoSmithKline ; STABILITY ClinicalTrials.gov number , NCT00799903 . )


The association between testosterone deficiency and insulin resistance in men with type 2 diabetes is well established .


Current Endocrine Society and European Association of Urology guidelines recommend the measurement of testosterone levels in all men with type 2 diabetes and in men suffering from erectile dysfunction .


It is recognised that a range of physical symptoms appear as the testosterone level falls but few studies have addressed the threshold at which symptoms improve with physiological replacement .


We report the first double-blind placebo-controlled study conducted exclusively in a male type 2 diabetes population to assess the metabolic changes with testosterone replacement .


The type 2 diabetes registers of seven general practices were screened to establish the prevalence of low testosterone and the associations with diabetes control .


Of 550 eligible patients approached , 488 men ( mean age 62.6 ) consented to take part in screening with a morning testosterone level , assessed between 8 and 11 am .


This identified 211 patients for a double-blind placebo-controlled study of long acting testosterone undecanoate ( TU ) 1000 mg lasting 30 weeks followed by 52 weeks of open label use .


The population was divided into a SEVERE group with either total testosterone ( TT ) of 8 nmol/l or less or free testosterone ( FT ) 180 pmol/l or less or a MILD group with TT 8.1-12 nmol/l or FT 181-250 pmol/l .


Men in the SEVERE group increased mean through TT from 7.73 nmol/l at baseline to 9.93 at 30 weeks and the MILD group from 10.47 to 11.94 .


The SEVERE group showed marked improvement in sexual function , but no significant improvement in metabolic parameters .


The MILD group showed no improvement in sexual function , but significant improvement in weight , body mass index , waist circumference and Hospital Anxiety and Depression Scale .


Improvement was seen in all parameters during 52 weeks open label treatment where trough TT levels approached 15 nmol/l .


Baseline prostate-specific antigen ( PSA ) was lower in the SEVERE group and increased with TU for 30 weeks and then stabilised .


There was no increase in PSA with treatment in the MILD group .


Testosterone undecanoate significantly improves sexual parameters and Ageing Male Symptom Score , but not metabolic factors at 30 weeks in men with SEVERE testosterone deficiency syndrome ( TDS ) .


In men with MILD TDS , significant improvements in metabolic but not sexual parameters were seen , suggesting that there are threshold levels for response to testosterone replacement therapy and that trials of therapy need to achieve sustained therapeutic levels to be effective .


PSA showed minor rises , but only for 30 weeks in the SEVERE group .


Randomized controlled trial .


Objectives To examine the efficacy of exercise intervention in patients with knee osteoarthritis ( OA ) , as directed by Mechanical Diagnosis and Therapy ( MDT ) assessment , and , secondarily , to explore outcomes between MDT assessment-defined subgroups within the exercise group .


Due to the high physical and economic burden of knee OA , the effectiveness of conservative interventions and determining those patients who will respond to them should be investigated .


Patients with knee OA ( n = 180 ) were randomized to an exercise intervention group or a control group .


The intervention group , in which patients classified as having knee derangements ( MDT derangement ) received MDT directional exercises and patients classified as nonresponders ( MDT nonresponders ) received evidence-based exercises , was compared to a control group that received no exercise intervention .


Pain and function were assessed at baseline , 2 weeks , and 3 months , using the P4 pain scale and Knee injury and Osteoarthritis Outcome Score ( KOOS ) pain and function subscales .


Two-way analysis of covariance was used to examine treatment and time effects .


Multiple comparisons were examined , and mean differences with 95 % confidence intervals ( CIs ) were reported .


The exercise intervention group had significantly improved P4 scores ( mean difference , -6 ; 95 % CI : -8 , -3 ) , KOOS pain scores ( mean difference , 9 ; 95 % CI : 5 , 13 ) , and KOOS function scores ( mean difference , 11 ; 95 % CI : 7 , 15 ) compared to those of the control group at 2 weeks .


At 3 months , the exercise intervention group had significantly improved KOOS pain scores ( mean difference , 7 ; 95 % CI : 3 , 11 ) and KOOS function scores ( mean difference , 5 ; 95 % CI : 1 , 9 ) compared to controls .


Patients with knee OA who were prescribed exercises based on an MDT assessment had superior outcomes compared to those of wait-list controls .


The MDT subgroup of knee derangement may warrant further investigation in patients with knee OA .


Protocol registered at ClinicalTrials.gov ( NCT01641874 ) .


Therapy , level 1b - .


Inappropriate use and overuse of antibiotics is a serious concern in the treatment of upper respiratory tract infections ( URTIs ) , especially in developing countries .


In recent decades , information disclosure and public reporting ( PR ) has become an instrument for encouraging good practice in healthcare .


This study evaluated the impact of PR on antibiotic prescribing for URTIs in a sample of primary care institutions in China .


A matched-pair cluster-randomized trial was undertaken in QJ city , with 20 primary care institutions participating in the trial .


Participating institutions were matched into pairs before being randomly assigned into a control and an intervention group .


Prescription statistics were disclosed to patients , health authorities , and health workers monthly within the intervention group , starting from October 2013 .


Outpatient prescriptions for URTIs were collected from both groups before ( 1st March to 31st May , 2013 ) and after the intervention ( 1st March to 31st May , 2014 ) .


A total of 34,815 URTI prescriptions were included in a difference-in-difference analysis using multivariate linear or logistic regression models , controlling for patient attributes as well as institutional characteristics .


Overall , 90 % URTI prescriptions required antibiotics and 21 % required combined use of antibiotics .


More than 77 % of URTI prescriptions required intravenous ( IV ) injection or infusion of drugs .


PR resulted in a 9 percentage point ( 95 % CI -17 to -1 ) reduction in the use of oral antibiotics ( adjusted RR = 39 % , P = 0.027 ) , while the use of injectable antibiotics remained unchanged .


PR led to a 7 percentage point reduction ( 95 % CI -14 to 0 ; adjusted RR = 36 % ) in combined use of antibiotics ( P = 0.049 ) , which was largely driven by a significant reduction in male patients ( -7.5 % , 95 % CI -14 to -1 , P = 0.03 ) .


The intervention had little impact on the use of IV injections or infusions , or the total prescription expenditure .


The results suggest that PR could improve prescribing practices in terms of reducing oral antibiotics and combined use of antibiotics ; however , the impacts were limited .


We suggest that PR would probably be enhanced by provider payment reform , management and training for providers , and health education for patients .


The aim of this study was to evaluate the effects of guided imagery as a nursing intervention for pain management and depression in patients diagnosed with fibromyalgia .


Many studies support the use of guided imagery to improve patient outcomes .


Guided imagery has been used for different purposes and it is thought to be an effective intervention for people suffering from nonmalignant pain .


A 2-group quasi-experimental study was conducted during 8 weeks by the University of Nursing in Almeria ( Spain ) .


Patients diagnosed with fibromyalgia aged 18 to 70 years ( n = 60 ) were randomly assigned to a guided imagery group ( n = 30 ) or a control group ( n = 30 ) .


The outcomes measures were scores for pain with the McGill Pain Questionnaire long form ( MPQ-LF ) and the Visual Analogue Scale ( VAS ) and depression with the Beck Depression Inventory and the VAS for depression .


The effects were examined at baseline , postintervention ( 4th week ) , and at the end of the study ( 8th week ) .


Treatment efficacy was analyzed by using a t test for paired samples .


Temporal changes in the scores were examined by using a 2-way repeated-measures analysis of variance .


The treatment group reported statistically significantly lower levels of pain ( P < .046 ) and depression ( P < .010 ) than the control group at the week 4 evaluation .


A statistically significant effect on pain as measured by the daily VAS diary was also found in the experimental group .


At week 8 , no significant differences were found for pain .


Patients diagnosed with fibromyalgia may benefit from this nursing intervention in terms of relieving pain and depression .


Guided imagery relaxation therapy could be incorporated as part of fibromyalgia treatment to promote health among people with fibromyalgia .


Guided imagery as a nursing intervention can alleviate pain and depression in patients diagnosed with fibromyalgia .


To characterize brain functional connectivity in subjects with prechiasmatic visual system damage and relate functional connectivity features to extent of vision loss .


In this case-control study , resting-state , eyes-closed EEG activity was recorded in patients with partial optic nerve damage ( n = 15 ) and uninjured controls ( n = 13 ) .


We analyzed power density and functional connectivity ( coherence , Granger causality ) , the latter as ( 1 ) between-areal coupling strength and ( 2 ) individually thresholded binary graphs .


Functional connectivity was then modulated by noninvasive repetitive transorbital alternating current stimulation ( rtACS ; 10 days , 40 minutes daily ; n = 7 ; sham , n = 8 ) to study how this would affect connectivity networks and perception .


Patients exhibited lower spectral power ( p = 0.005 ) , decreased short - ( p = 0.015 ) and long-range ( p = 0.033 ) coherence , and less densely clustered coherence networks ( p = 0.025 ) in the high-alpha frequency band ( 11-13 Hz ) .


rtACS strengthened short - ( p = 0.003 ) and long-range ( p = 0.032 ) alpha coherence and this was correlated with improved detection abilities ( r = 0.57 , p = 0.035 ) and processing speed ( r = 0.56 , p = 0.049 ) , respectively .


Vision loss in the blind is caused not only by primary tissue damage but also by a breakdown of synchronization in brain networks .


Because visual field improvements are associated with resynchronization of alpha band coherence , brain connectivity is a key component in partial blindness and in restoration of vision .


To compare the effects on left ventricular ( LV ) function of right ventricular ( RV ) septal pacing vs. cardiac resynchronization therapy ( CRT ) in patients with an indication for the latter .


Cardiac resynchronization therapy is an effective therapy in patients with drug-refractory heart failure .


Despite advances in implantation techniques , LV lead placement can be impossible in up to 10 % of cases .


We , therefore , assessed the effects of RV septal pacing from mid septum ( RVmIVS ) and outflow tract ( RVOT ) on cardiac performance , in comparison with CRT .


Twenty-two patients scheduled for CRT underwent dual-chamber temporary pacing .


The ventricular lead was placed at the RV apex ( RVA ) , RVmIVS , and RVOT in random order .


Comprehensive echocardiography was performed in a baseline AAI mode and then at each RV position in dual chamber pacemaker function ( D pacing , D sensing , D dual responses ) mode and repeated on the next day following CRT implantation .


Right ventricular apex pacing did not change any of the assessed echocardiography parameters .


Both RVmIVS and RVOT pacing increased LV ejection fraction ( EF ) : 29 7 % at baseline vs. 32 6 % ( P = 0.02 ) and 32 5 % ( P = 0.04 ) with RVmIVS and RVOT pacing , respectively .


Similarly , the dyssynchrony index ( Ts-SD ) decreased : 50 19 ms at baseline vs. 39 17 ms ( P = 0.04 ) and 37 17 ms ( P = 0.006 ) with RVmIVS and RVOT pacing , respectively .


Cardiac resynchronization therapy further improved LVEF and Ts-SD to 36 7 % and 34 15 ms , respectively , however , only LVEF was significantly higher compared with RVmIVS and RVOT pacing ( P = 0.03 and P = 0.01 respectively ) .


There were no significant differences in either LVEF or Ts-SD between RVmIVS and RVOT .


Right ventricular septal pacing from mid septum or RVOT pacing improves LVEF and LV synchrony in CRT candidates .


Further improvement in LVEF was achieved by CRT , which remains the ` gold standard ' therapy in these patients .


However , RV septal pacing is worthy of further study as an alternative strategy when LV lead implantation fails .


To investigate variables associated with myopic progression despite treatment in the Atropine in the Treatment of Myopia Study .


Retrospective cohort study .


Two hundred of 400 children were randomized to receive atropine 1 % in 1 eye only in this institutional study .


Children were followed up with cycloplegic autorefraction every 4 months over 2 years .


Children whose myopia progressed by more than 0.5 diopter ( D ) in the atropine-treated eye at 1 year were classified as being progressors .


Among the 182 children still in the study at 1 year , 22 ( 12.1 % ) were classified as progressors .


Univariate analysis suggested these children tended to be younger ( 8.5 1.4 years vs 9.3 1.5 years ; P = .023 ) , to have higher myopic spherical equivalent ( SE ) at baseline ( -3.6 1.3 D vs -2.8 1.4 D ; P = .015 ) , and to have 2 myopic parents ( 77.3 % vs 48.1 % ; P = .012 ) .


In nonprogressors , the myopia progression at 1 year was less in the atropine-treated eyes compared with the untreated fellow eye ( +0.16 0.37 D vs -0.73 0.48 D ; P < .001 ) , but in progressors , progression was more similar between eyes ( -0.92 0.31 D vs -1.06 0.44 D ; P = .363 ) .


Regression analysis showed that the risk of being a progressor was 40 % lower with each year of increased age , 43 % lower for every 1.0 D less in myopia at baseline , and 59 % lower for every 1.0 D less in myopic change in the untreated eyes over the first year .


Doctors and parents need to be aware that there is a small group of children ( younger , with higher myopia , and greater tendency of myopic progression ) who may still progress while receiving atropine treatment .


Combined treatment of a calcium antagonist and / - adrenoreceptor blocker is expected to offer some advantages in the management of hypertension ; however , their antihypertensive efficacy and safety remain relatively under-explored .


The current study addresses the 24-h antihypertensive efficacy and safety of arotinolol combined with a different calcium channel blocker .


One-hundred fifty-two patients were randomly divided into three groups : nifedipine , amlodipine and felodipine group .


In each group , the antihypertensive treatment dose was 30mg/d , 5mg/d , 5mg/d long acting nifedipine , amlodipine , felodipine plus 20mg/d arotinolol , respectively .


Blood pressure was measured in ABPM devices and mercury manometer .


The result showed that the effective rate of one year antihypertensive treatment of arotinolol combined with nifedipine was 51 of 53 , significantly effective ( p < 0.05 ) among three combinations .


It also showed that there was no statistical significant difference ( p > 0.05 ) in controlled rate of morning peak blood pressure between treatment of arotinolol combined with amlodipine and arotinolol combined with nifedipine , but there was a significant difference ( p < 0.01 ) in controlled rate of morning peak blood pressure between arotinolol combined with nifedipine vs. felodipine and arotinolol combined with amlodipine vs. felodipine .


The therapy approached of arotinolol combined with nifedipine or amlodipine could be effective and well-tolerated , and they can be used as the better chosen antihypertensive drug .


Most research on the Illness Management and Recovery ( IMR ) program for people with severe mental illnesses has focused on individuals with stable symptoms living in the community , with less attention to persons being treated in an inpatient setting .


We evaluated the feasibility and effects of an IMR program adapted for individuals with schizophrenia who were awaiting discharge into the community .


A randomized controlled trial was conducted at 2 hospitals in Taiwan to compare the adapted IMR program with treatment as usual ( TAU ) .


Ninety-seven individuals with schizophrenia were randomized to the adapted IMR program or TAU .


Four outcome indicators including illness-management knowledge , attitudes toward medication , insight , and symptoms were assessed at baseline , posttreatment , and at a 1-month follow-up following discharge from the hospital .


Participants in the adapted IMR group showed significantly greater improvements at posttreatment and 1-month follow-up in illness-management knowledge , attitudes toward medication , insight , and negative symptoms on the Brief Psychiatric Rating Scale ( BPRS ) than individuals in the TAU group .


There were no significant differences between the 2 groups on other subscales of the BPRS .


This is the first controlled evaluation of a version of the IMR program in an East Asian culture , and the first to evaluate it in an acute care inpatient setting .


Our findings support the feasibility and potential benefits of implementing an adapted IMR program , focused on the prevention of relapses and rehospitalizations , during the discharge period of an inpatient treatment stay to prepare individuals to reenter the community .


Following discharge home from the ICU , patients often suffer from reduced physical function , exercise capacity , health-related quality of life and social functioning .


There is usually no support to address these longer term problems , and there has been limited research carried out into interventions which could improve patient outcomes .


The aim of this study is to investigate the effectiveness and cost-effectiveness of a 6-week programme of exercise on physical function in patients discharged from hospital following critical illness compared to standard care .


The study design is a multicentre prospective phase II , allocation-concealed , assessor-blinded , randomised controlled clinical trial .


Participants randomised to the intervention group will complete three exercise sessions per week ( two sessions of supervised exercise and one unsupervised session ) for 6weeks .


Supervised sessions will take place in a hospital gymnasium or , if this is not possible , in the participants home and the unsupervised session will take place at home .


Blinded outcome assessment will be conducted at baseline after hospital discharge , following the exercise intervention , and at 6months following baseline assessment ( or equivalent time points for the standard care group ) .


The primary outcome measure is physical function as measured by the physical functioning subscale of the Short-Form-36 health survey following the exercise programme .


Secondary outcomes are health-related quality of life , exercise capacity , anxiety and depression , self efficacy to exercise and healthcare resource use .


In addition , semi-structured interviews will be conducted to explore participants ' perceptions of the exercise programme , and the feasibility ( safety , practicality and acceptability ) of providing the exercise programme will be assessed .


A within-trial cost-utility analysis to assess the cost-effectiveness of the intervention compared to standard care will also be conducted .


If the exercise programme is found to be effective , this study will improve outcomes that are meaningful to patients and their families .


It will inform the design of a future multicentre phase III clinical trial of exercise following recovery from critical illness .


It will provide useful information which will help the development of services for patients after critical illness .


ClinicalTrials.gov NCT01463579 .


The primary aims of this hybrid Type 1 effectiveness-implementation trial were to quantitatively assess whether an evidence-based exercise intervention for breast cancer survivors , Strength After Breast Cancer , was safe and effective in a new setting and to qualitatively assess barriers to implementation .


A cohort of 84 survivors completed measurements related to limb volume , muscle strength , and body image at baseline , 67 survivors completed measurements 12 months later .


Qualitative methods were used to understand barriers to implementation experienced by referring oncology clinicians and physical therapists who delivered the program .


Similar to the efficacy trial , the revised intervention demonstrated safety with regard to lymphedema , and led to improvements in lymphedema symptoms , muscular strength , and body image .


Comparison of effects in the effectiveness trial to effects in the efficacy trial revealed larger strength increases in the efficacy trial than in the effectiveness trial ( P < .04 ) , but few other differences were found .


Qualitative implementation data suggested significant barriers around intervention characteristics , payment , eligibility criteria , the referral process , the need for champions ( ie , advocates ) , and the need to adapt during implementation of the intervention , which should be considered in future dissemination and implementation efforts .


This trial successfully demonstrated that a physical therapy led strength training program for breast cancer survivors can be implemented in a community setting while retaining the effectiveness and safety of the clinical trial .


However , during the translation process , strategies to reduce barriers to implementation are required .


This new program can inform larger scale dissemination and implementation efforts .


Physical activity has been related to improved breast cancer outcomes .


Especially in the older breast cancer population , physical activity may be important because old age is associated with comorbidities and decreased physical function .


The purpose of this study was to investigate the relation between physical activity and overall survival , breast cancer-specific survival , and recurrence in several age groups of postmenopausal breast cancer patients .


The Tamoxifen Exemestane Adjuvant Multinational Lifestyle study was a side study of the Tamoxifen Exemestane Adjuvant Multinational trial and prospectively investigated lifestyle habits of postmenopausal , hormone receptor-positive breast cancer patients .


The relations between prediagnosis and postdiagnosis physical activity and overall survival , breast cancer-specific survival , and recurrence-free survival were assessed with Cox regression and competing risk regression models .


Among 521 patients , high levels of physical activity before and after the diagnosis were associated with better overall survival ( the multivariate hazard ratios were 0.50 [ 95 % confidence interval = 0.26-0 .98 ] and 0.57 ( 95 % confidence interval = 0.26-1 .40 ] for patients who were very active before and after the diagnosis , respectively , in comparison with inactive patients ) .


This was most evident in patients who were 65 years old or older .


Physical activity was not significantly associated with breast cancer-specific survival or the relapse-free period .


Overall survival was better for patients who were active before and after the diagnosis .


In contrast with previous studies , breast cancer survival and the risk of recurrence were not significantly associated with physical activity .


These findings confirmed the need for more studies investigating the use of physical activity to supplement breast cancer treatment in older patients .


This article investigated how a multicomponent memory intervention affected memory for prose .


We compared verbatim and paraphrased recall for short stories immediately and 1 , 2 , 3 , and 5 years post-intervention in the Advanced Cognitive Training for Independent and Vital Elderly ( ACTIVE ) sample .


We studied 1,912 ACTIVE participants aged 65 to 91 .


Participants were randomized into one of three training arms ( Memory , Reasoning , Speed of Processing ) or a no-contact Control group ; about half of the trained participants received additional booster training 1 and 3 years post-intervention .


Memory-trained participants showed higher verbatim recall than non-memory-trained participants .


Booster-memory training led to higher verbatim recall .


Memory training effects were evident immediately following training and not after 1 year following training .


Results suggest that multifactorial memory training can improve verbatim recall for prose , but the effect does not last without continued intervention .


This study was developed as a pilot study to determine if targeted interventions regarding increasing physical activity level through the use of pedometers and fitness DVDs would result in a decrease in BMI in overweight or obese children .


24 children aged 4-17 taking part in `` Moving and Losing '' were randomized to ( 1 ) Control Group ; ( 2 ) Pedometer Group ; ( 3 ) DVD Group ; ( 4 ) Pedometer + DVD Group and asked to complete self-report physical activity logs at visit one and two .


Baseline , midpoint , and endpoint weight , height , Body Mass Index ( BMI ) were measured for outcome variables .


Almost half ( 42 % ) of participants turned in their activity logs and pedometers at midpoint , but at endpoint less than a quarter of participants turned in their pedometers and/or activity logs .


BMI increased by 4.1 % in the Control Group , 8.7 % in the Pedometer Group , and 6.7 % in the DVD Group .


BMI decreased by 0.3 % in the Pedometer + DVD Group .


The use of pedometers and fitness DVDs may not be culturally acceptable in African-American female children and adolescents from South Carolina who are overweight or obese .


Further studies should look into in-depth needs assessments and planning processes that include participants as stakeholders .


Bronchodilator medications are central to the symptomatic management of chronic obstructive pulmonary disease ( COPD ) .


Metered-dose inhalers ( MDIs ) are the most commonly used devices to deliver treatment to patients with COPD and asthma , comprising approximately 70 % of bronchodilator prescriptions .


Proprietary porous-particle technology permits the formulation of long-acting muscarinic antagonists , long-acting 2-agonists , and a combination of both in hydrofluoroalkane ( HFA ) MDIs , providing a solution to formulation challenges inherent to the development of HFA MDIs , which have contributed to the development of dry-powder inhalers .


In this randomized , double-blind , 4-period , 6-treatment , placebo - and active-controlled , multicenter , crossover study , 4 ascending single doses of a proprietary glycopyrronium ( GP ) MDI were evaluated compared with Placebo MDI and open-label tiotropium ( TIO ) in study patients with COPD .


Thirty-three study patients were enrolled and received single-dose administration of 4 of the 6 treatments ( Placebo MDI , TIO 18 g , or GP MDI at 14.4 , 28.8 , 57.6 , and 115.2 g ex-actuator ) with an interval of 1 to 3 weeks between doses .


The primary efficacy endpoint was peak change in forced expiratory volume in 1 second ( FEV1 ) .


All 4 doses of GP MDI showed statistically superior efficacy compared with Placebo MDI for peak FEV1 ( differences of 146 to 248 mL ; P < .001 ) , with a clear dose ordering of the response .


Statistically significant differences compared with Placebo MDI were noted at almost all doses for the secondary FEV1 parameters ( P .049 ) except 24-hour trough FEV1 at 28.8 g. All doses were safe and well tolerated in this study ; the most frequently reported adverse event was dry mouth ( 0-14 .3 % across doses ; 9.5 % for Placebo MDI , and 9.1 % for TIO ) .


This study demonstrated superior bronchodilatory efficacy of GP MDI compared with Placebo MDI at all doses tested , and no serious adverse events were reported .


This study supports the further evaluation of GP MDI in study patients with COPD .


In addition , these findings indicate that the correct dosage of glycopyrronium is no more than 115.2 g total daily dose , or 57.6 g twice daily based on comparisons with the active comparator .


This clinical trial was registered on ClinicalTrials.gov , Identifier : NCT00871182 .


We aimed to determine the timing and size of the cognitive deficit associated with poverty in the first 5 years of life and to examine the role of parental characteristics , pre - and postnatal growth , and stimulation in the home in Bangladeshi children .


We hypothesized that the effect of poverty on cognition begins in infancy and is mainly mediated by these factors .


We enrolled 2853 singletons , a subsample from a pregnancy supplementation trial in a poor rural area .


We assessed mental development at 7 , 18 , and 64 months ; anthropometry at birth , 12 , 24 , and 64 months ; home stimulation at 18 and 64 months ; and family 's socioeconomic background .


In multiple regression analyses , we examined the effect of poverty at birth on IQ at 64 months and the extent that other factors mediated the effect .


A mean cognitive deficit of 0.2 ( 95 % confidence interval -0.4 to -0.02 ) z scores between the first and fifth wealth quintiles was apparent at 7 months and increased to 1.2 ( 95 % confidence interval -1.3 to -1.0 ) z scores of IQ by 64 months .


Parental education , pre - and postnatal growth in length , and home stimulation mediated 86 % of the effects of poverty on IQ and had independent effects .


Growth in the first 2 years had larger effects than later growth .


Home stimulation had effects throughout the period .


Effects of poverty on children 's cognition are mostly mediated through parental education , birth size , growth in the first 24 months , and home stimulation in the first 5 years .


To compare the short-term outcomes of patients who underwent proximal gastrectomy with jejunal interposition ( PGJI ) with those undergoing total gastrectomy with Roux-en-Y anastomosis ( TGRY ) .


From January 2009 to January 2011 , thirty-five patients underwent PGJI , and forty-one patients underwent TGRY .


The surgical efficacy and short-term follow-up outcomes were compared between the two groups .


There were no differences in the demographic and clinicopathological characteristics .


The mean operation duration and postoperative hospital stay in the PGJI group were statistically longer than those in the TGRY group ( P = 0.00 ) .


No anastomosis leakage was observed in two groups .


No statistically significant difference was found in endoscopic findings , Visick grade or serum albumin level .


The single-meal food intake in the PGJI group was more than that in the TGRY group ( P = 0.00 ) .


The PG group showed significantly better hemoglobin levels in the second year ( P = 0.02 ) .


The two-year survival rate was not significantly different ( PGJI vs TGRY , 93.55 % vs 92.5 % , P = 1.0 ) .


PGJI is a safe , radical surgical method for proximal gastric cancer and leads to better outcomes in terms of the single-meal food intake and hemoglobin level , compared with TGRY in the short term .


An endoscopic ultrasound ( EUS ) - guided fine needle biopsy ( EUS-FNB ) device using a core biopsy needle was developed to improve diagnostic accuracy by simultaneously obtaining cytological aspirates and histological core samples .


We prospectively compared the diagnostic accuracy of EUS-FNB with standard EUS-guided fine needle aspiration ( EUS-FNA ) in patients with solid pancreatic masses .


Between January 2012 and May 2013 , consecutive patients with solid pancreatic masses were prospectively enrolled and randomized to undergo EUS-FNB using a core biopsy needle or EUS-FNA using a standard aspiration needle at a single tertiary center .


The specimen was analyzed by onsite cytology , Papanicolaou-stain cytology , and histology .


The main outcome measure was diagnostic accuracy for malignancy .


The secondary outcome measures were : the median number of passes required to establish a diagnosis , the proportion of patients in whom the diagnosis was established with each pass , and complication rates .


The overall accuracy of combining onsite cytology with Papanicolaou-stain cytology and histology was not significantly different for the FNB ( n = 58 ) and FNA ( n = 58 ) groups ( 98.3 % [ 95 % CI 94.9 % -100 % ] vs. 94.8 % [ 95 % CI 91.9 % -100 % ] ; P = 0.671 ) .


Compared with FNA , FNB required a significantly lower median number of needle passes to establish a diagnosis ( 1.0 vs. 2.0 ; P < 0.001 ) .


On subgroup analysis of 111 patients with malignant lesions , the proportion of patients in whom malignancy was diagnosed on the first pass was significantly greater in the FNB group ( 72.7 % vs. 37.5 % ; P < 0.001 ) .


The overall accuracy of FNB and FNA in patients with solid pancreatic masses was comparable ; however , fewer passes were required to establish the diagnosis of malignancy using FNB.This study was registered on the UMIN Clinical Trial Registry ( UMIN000014057 ) .


Patients with recurrent sinonasal polyposis after endoscopic sinus surgery ( ESS ) have limited treatment options .


This study evaluated the safety and efficacy of a bioabsorbable steroid-eluting implant with 1350 g of mometasone furoate for its ability to dilate obstructed ethmoid sinuses , reduce polyposis , and reestablish sinus patency .


This was a randomized , controlled , blinded study including 100 patients chronic rhinosinusitis with nasal polyposis ( CRSwNP ) refractory to medical therapy and considered candidates for revision ESS .


Follow-up included endoscopic grading by investigators and patient-reported outcomes .


Treated patients ( n = 53 ; age as mean standard deviation [ SD ] 47.8 12.6 years ; 55 % male ) underwent in-office bilateral placement .


Control patients ( n = 47 ; age 51.6 13.1 years ; 66 % male ) underwent a sham procedure .


At 3months , treated patients experienced a significant reduction in bilateral polyp grade ( p = 0.0269 ) and ethmoid sinus obstruction ( p = 0.0001 ) compared to controls .


Treated patients also experienced a 2-fold improvement in the mean nasal obstruction/congestion score ( -1.33 1.47 vs -0.67 1.45 ; p = 0.1365 ) .


This improvement reached statistical significance ( p = 0.025 ) in patients with greater polyp burden ( grade 2 bilaterally ; n = 74 ) .


At 3months , 53 % of treated patients compared to only 23 % of controls were no longer indicated for repeat ESS .


There was no serious adverse event or clinically significant increases in intraocular pressure or cataract formation .


The symptomatic improvement and statistically significant reduction in polyp grade and ethmoid sinus obstruction supported the efficacy of the steroid-eluting implant for in-office treatment of CRS patient with recurrent polyposis after ESS .


The study results demonstrated that the steroid-eluting implant represents a safe and effective alternative to current management for this patient population .


Chronic Low Back Pain is a complex syndrome with multifactorial bio-psycho-social etiology and interdependences .


Thereby , physical activity seems to play an essential role regarding the prevention and rehabilitation of LBP .


In consequence , physical activity and exercise therapy is an integral part of musculoskeletal rehabilitation in LBP .


However , adherence to self-directed exercise and implementing a health-enhancing physical activity in daily routine after rehabilitation is a common problem for patients and only a few patients integrate health-enhancing physical activity and/or sport activities in their lifestyle .


The present paper describes a comprehensive multilevel approach combining face-to-face intervention , telephone and internet aftercare ( Movement Coaching ) .


Aim of the trial presented in this study protocol is to evaluate effectiveness of Movement Coaching compared to a control intervention .


The study is a prospective , single-blinded , monocenter randomized controlled trial ( RCT ) with three measuring points : T1 = start of inpatient rehabilitation ; T2 = six months follow-up ; T3 = twelve months follow-up .


In total , 412 patients were recruited .


The intervention involves small-group face-to-face contact during inpatient rehabilitation ( two times , week 2 & 3 ) and telephone aftercare ( week 8 & week 12 after rehabilitation ) as well as internet-based aftercare ( web 2.0 platform ; available until six months after rehabilitation ) .


Primary outcome is physical activity , assessed by GPAQ questionnaire .


The final data collection is expected by April 2015 .


Due to the burden of physical inactivity , there is a need to develop , evaluate and disseminate approaches that are effective in promoting physical activity and especially promoting the maintenance of physical activity in relevant target groups .


Considering the high prevalence and socioeconomic impact of low back pain and its multifactorial etiology , low back pain patients seem to be a relevant target group for physical activity promotion .


A multilevel approach to bridge the interface of ( inpatient ) rehabilitation and self-directed physical activity will help to target group-specific PA promotion .


German Clinical Trials Register ( DRKS ) - ID : DRKS00004878 .


There is controversy about the efficacy of currently used treatment modalities to alleviate migraine headaches .


We aimed to evaluate and compare the effects of magnesium sulfate and combined use of dexamethasone/metoclopramide on relieving acute migraine headache .


We randomly divided 70 patients who had been referred to an emergency department , into two equal treatment groups with the two treatment plans , and analyzed pain severity at baseline using a numeric rating scale ( NRS ) .


We gave dexamethasone/metoclopramide to one group and magnesium sulfate to the other group , and evaluated pain severity at 20 min and at 1 - and 2-h intervals after infusion .


Finally , we used repeated-measure and two-way analysis of variance for intra - and inter-group evaluations of pain severity and complications , respectively .


We found no significant differences in demographic data and pain severity at baseline ( 8.2 vs. 8.0 ) between the two groups ( p < 0.05 ) .


In the dexamethasone/metoclopramide group , pain severity ( mean standard deviation ) was 7.4 1.4 ( p = 0.36 ) , 6.0 2.4 , and 2.5 2.9 ( p < 0.0001 ) at 20-min , 1-h , and 2-h intervals after treatment , respectively , with statistically significant differences between the baseline values and 1-h and 2-h interval values .


Administration of magnesium sulfate was associated with decreased pain severity at the three intervals ( 5.2 1.7 , 2.3 1.9 , and 1.3 0.66 , respectively ) , exhibiting significant differences compared to baseline values and the corresponding time intervals in the dexamethasone/metoclopramide group ( p < 0.0001 ) .


According to the results , magnesium sulfate was a more effective and fast-acting medication compared to a combination of dexamethasone/metoclopramide for the treatment of acute migraine headaches .


The association between the interleukin IL1 beta gene polymorphisms SNP-511 and SNP +3953 and susceptibility to the development of Hashimoto 's thyroiditis among adult Caucasian-Polish population were analyzed .


The group studied comprised of 115 unrelated patients with Hashimoto 's thyroiditis ( 112 women and 3 men , mean age 53.3 years ) .


All patients were euthyroid on thyroid replacement therapy , had extremely high serum anti-TPO levels and in 53 patients anti-TG levels were also increased .


The control group consisted of 103 healthy blood donors without raised anti-TPO antibodies , in whom a personal and familial history of thyroid , autoimmune and inflammatory diseases was excluded .


No goiter or thyroid dysfunction was found .2 polymorphisms of the IL1 beta were studied by PCR-RFLP analysis .


To confirm the accuracy of the method used , randomly selected patients were analyzed by direct sequencing .


In both groups allele frequencies were in Hardy-Weinberg equilibrium .


The significant statistical differences between the frequency of C and T allele for both SNPs ( C-511T and C +3953 T ) in the group studied and in the controls were found ( p = 0.0081 ; OR = 1.846 ; 95 % CI : 1.183-2 .878 and p = 0.0099 ; OR = 1.953 ; 95 % CI : 1.183-3 .224 ) .


The frequencies of the genotype C-511C compared to C-511T and T-511T as well as C +3953 C compared to C +3953 T and T +3953 T also differed significantly ( p = 0.0057 ; OR = 2.248 ; 95 % CI : 1.292-3 .912 and p = 0.0043 ; OR = 2.338 ; 95 % CI : 1.305-4 .191 ) between patients and controls .


An association between the SNPs of the IL1 beta and susceptibility to Hashimoto 's thyroiditis among the group of Caucasian-Polish population studied was found .


Antalgic radiotherapy for bone metastases might be improved by implementing biological information in the radiotherapy planning using ( 18 ) F-FDG-PET-CT based dose painting by numbers ( DPBN ) .


Patients with uncomplicated painful bone metastases were randomized ( 1:1:1 ) and blinded to receive either 8Gy in a single fraction with conventionally planned radiotherapy ( arm A ) or 8Gy in a single fraction with DPBN ( dose range between 610Gy and 10Gy ) ( arm B ) or 16Gy in a single fraction with DPBN ( dose range between 1410Gy and 18Gy ) ( arm C ) .


The primary endpoint was overall pain response at 1month .


The phase II trial was designed to select the experimental arm with sufficient promise of efficacy to continue to a phase III trial .


Forty-five patients were randomized .


Eight ( 53 % ) , 12 ( 80 % ) and 9 patients ( 60 % ) had an overall response to treatment in arm A , B and C , respectively .


The estimated odds ratio of overall response for arm B vs. A is 3.5 ( 95 % CI : 0.44-17 .71 , p = 0.12 ) .


The estimated odds ratio of arm C vs. A is 1.31 ( 95 % CI : 0.31-5 .58 , p = 0.71 ) .


A single fraction of 8Gy with DPBN will be further evaluated in a phase III-trial .


This study evaluated the impact of nonculprit vessel myocardial perfusion on outcomes of non-ST-segment elevation acute coronary syndromes ( NSTE-ACS ) patients .


ST-segment elevation myocardial infarction patients have decreased perfusion in areas remote from the infarct-related vessel .


The impact of myocardial hypoperfusion of regions supplied by nonculprit vessels in NSTE-ACS patients treated with percutaneous coronary intervention ( PCI ) is unknown .


The angiographic substudy of the ACUITY ( Acute Catheterization and Urgent Intervention Triage Strategy ) trial included 6,921 NSTE-ACS patients .


Complete 3-vessel assessments of baseline coronary TIMI ( Thrombolysis In Myocardial Infarction ) flow grade and myocardial blush grade ( MBG ) were performed .


We examined the outcomes of PCI-treated patients according to the worst nonculprit vessel MBG identified per patient .


Among the 3,826 patients treated with PCI , the worst nonculprit MBG was determined in3 ,426 ( 89.5 % ) patients , including 375 ( 10.9 % ) MBG 0/1 patients , 475 ( 13.9 % ) MBG 2 patients , and 2,576 ( 75.2 % ) MBG 3 patients .


Nonculprit MBG 0/1 was associated with worse baseline clinical characteristics .


Patients with nonculprit MBG 0/1 versus MBG 3 had increased rates of 30-day ( 3.0 % vs. 0.7 % , p < 0.0001 ) and 1-year ( 4.4 % vs. 1.0 % , p < 0.0001 ) death .


Similar results were found among patients with pre-procedural TIMI flow grade 3 in the culprit vessel , where nonculprit vessel MBG 0/1 ( hazard ratio : 2.81 [ 95 % confidence interval : 1.63 to 4.84 ] , p = 0.0002 ) was the strongest predictor of 1-year mortality .


Reduced myocardial perfusion in an area supplied by a nonculprit vessel is associated with increased short - and long-term mortality rates in NSTE-ACS patients undergoing PCI .


Furthermore , worst nonculprit MBG is able to risk-stratify patients with normal baseline flow of the culprit vessel .


Mechanical insufflation-exsufflation ( MI-E ) , more commonly known as ` cough assist therapy ' , is a method which produces inspiratory and expiratory assistance to improve cough performances .


However , other alternatives or combinations are possible .


The objective was to compare the effects of mechanical insufflation combined with manually assisted coughing ( MAC ) , insufflation-exsufflation alone and insufflation-exsufflation combined with MAC in neuromuscular patients requiring cough assistance .


Eighteen neuromuscular patients with severe respiratory muscle dysfunction and peak cough flow ( PCF ) lower than 3 liters/s or maximal expiratory pressure ( MEP ) lower than +45 cm H2O were studied .


Patients were studied under three cough-assisted conditions , which were used in random order : insufflation by intermittent positive-pressure breathing ( IPPB ) combined with MAC , MI-E and MI-E + MAC .


Overall , PCF was higher with IPPB + MAC than with MI-E + MAC or MI-E alone .


Among the 12 patients who had higher PCF values with IPPB + MAC than with the two other techniques , 9 exhibited mask pressure swings during MI-E exsufflation , with a transient positive-pressure value due to the expiratory flow produced by the combined patient cough effort and MAC .


Each of these 9 patients had higher PCF values ( > 5 liters/s ) than did the other 9 patients when using IPPB + MAC .


Our results indicate that adding the MI-E device to MAC is unhelpful in patients whose PCF with an insufflation technique and MAC exceeds 5 liters/s .


This is because the expiratory flow produced by the patient 's effort and MAC transitorily exceeds the vacuum capacity of the MI-E device , which therefore becomes a transient load against the PCF .


The objective of this study was to evaluate the safety and efficacy of SprayShield Adhesion Barrier in preventing and/or reducing postoperative adhesion during gynecological surgery .


This was a prospective , controlled , blinded , and randomized study .


Patient blinding was performed intraoperatively .


Subjects were randomly assigned to the SprayShield or the control group in a 2:1 ratio .


The study was conducted at the Clinic of Gynaecology and Obstetrics , at the University Hospital for Gynecology in Germany .


Fifteen patients participated in this study ; nine patients were assigned to the SprayShield and six patients to the control group .


During first operation ( FLL ) in the SprayShield group , the agent was applied to all myomectomy suture lines .


Patients in the control group did not receive any anti-adhesion treatment , only good surgical practice .


A second-look laparoscopy ( SLL ) was performed 8-12weeks after myomectomy to evaluate adhesion formation .


Main outcome measures were incidence , severity , and extent of uterine adhesions .


No significant differences were found between the two study groups .


SprayShield is easy to use .


No serious adverse event related to SprayShield was observed .


Efficacy data are inconclusive regarding the performance of SprayShield .


Further studies are needed to better understand this performance .


To compare an efficacy of a moisturizer containing spent grain wax , Butyrospermum parkii extract , Argania spinosa kernel oil ( S ) with 1 % hydrocortisone cream ( HC ) for the treatment of mild to moderate atopic dermatitis .


Twenty-nine patients , age between 2 and 15 years old with mild to moderate atopic dermatitis were enrolled The body was randomly divided to left and right side .


One side was applied with S cream and the other side was applied with HC cream twice daily for four weeks .


Observation of recurrence rate after remission was recorded .


Clinical outcomes were analyzed by using the scoring ofAtopic Dermatitis ( SCORAD ) score .


Statistical analysis was done by using descriptive statistics , pair t-test , one-way repeated ANOVA , and McNemar 's test .


It was demonstrated that both agents had improvement of SCORAD score after two weeks , with statistically significant difference ( p < 0.001 ) .


At fourth week , both agents had improvement of SCORAD score without being statistically significant different ( p > 0.05 ) .


Although the S cream side had higher remission rate than the HC cream side , there was no statistically significant difference ( p > 0.05 ) .


S cream was as effective as HC cream in the treatment and maintenance period of mild to moderate childhood atopic dermatitis .


Intracranial arteriovenous malformations ( AVMs ) are associated with high morbidity and mortality .


Modern microsurgery has improved the results of surgical treatment of AVMs ; however , the treatment of AVMs , particularly eloquently located AVMs , still carries a high risk .


Functional MRI ( fMRI ) has been reported to be used for the preoperative evaluation of AVMs in small case series .


The purpose is to identify the utility and efficacy of fMRI-guided microsurgery of AVMs in a large randomised controlled trial .


The study is a prospective , randomised controlled clinical trial .


This study will enrol a total of 600 eligible patients .


These eligible patients will be randomised to the standard microsurgery group and the fMRI-guided microsurgery group in a 1:1 ratio .


Patient baseline characteristics and AVM architecture and characteristics will be described .


In the fMRI-guided group , fMRI mapping of an eloquent cortex in all AVMs will be identified .


Surgical complications and outcomes at pretreatment , post-treatment , at discharge and at 1-month , 3-month and 6-month follow-up intervals will be analysed using the modified Rankin Scale ( mRS ) .


This trial will determine whether fMRI-guided microsurgery could improve outcomes in patients with AVMs and also identify the safety and efficacy of fMRI-guided microsurgery .


The study protocol and written informed consent were reviewed and approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University ( ky2012-016-02 ) .


Study findings will be disseminated in the printed media .


ClinicalTrials.gov NCT01758211 .


Definitive therapy is not defined for the management of oral submucous fibrosis ( OSMF ) .


This study evaluated the efficacy of aloe vera gel as an adjuvant treatment of OSMF .


A double-blind , placebo-controlled , parallel-group randomized controlled trial was conducted on 60 subjects with OSMF divided into medicinal treatment ( submucosal injection of hyaluronidase and dexamethasone , n = 30 ) and surgical treatment ( n = 30 ) categories .


Each category was randomly divided into groups A ( with aloe vera , n = 15 per category ) and B ( without aloe vera , n = 15 per category ) .


Follow-up assessment for various symptoms was performed , and results were analyzed using paired and unpaired Student t tests .


The group receiving aloe vera had a significant improvement in most symptoms of OSMF ( P < .01 ) compared with the non-aloe vera group , in both the medicinal and surgical categories .


Aloe vera gel was effective as an adjuvant in treatment of OSMF .


As clinical studies conducted to explore the safety and efficacy of new procedures are considered an important focus in endodontic research , the aim of this controlled clinical study was to compare a laser-assisted endodontic treatment using an erbium , chromium : yttrium-scandium-gallium-garnet ( Er , Cr : YSGG ) laser and radial firing tips ( RFT ) versus the conventional use of 3 % sodium hypochlorite and interim calcium hydroxide paste , in teeth with chronic apical periodontitis .


Forty-three single-rooted and premolar teeth were randomly assigned .


In group 1 , teeth were prepared and irrigated with 3 % sodium hypochlorite and calcium hydroxide inter-appointment dressing was applied ; in group 2 teeth were prepared with saline solution and irradiated with Er , Cr : YSGG laser using RFT2 ( 140 s , 37.5 mJ , 20 Hz ) and RFT3 ( 140 s , 62.5 mJ , 20 Hz ) at the first and second appointments , respectively , four times each , moving at 2 mm/sec ( -1 ) from apical to coronal .


The primary outcome measure was change in apical bone density at 12 months , using the periapical index ( PAI ) for blind radiographic assessment .


Thirty teeth were examined and subjected to statistical analysis , 12 in the control group and 18 in the test group .


There were two treatment failures in the control group that were not included for analysis ; both groups exhibited statistically significant decreases in PAI scores .


The present findings suggest that for single-rooted and premolar teeth , this laser-assisted protocol can achieve predictable endodontic outcomes , comparable to conventional strategies in 1 year of follow-up .


To assess the relative importance of independent risk factors for peripheral intravenous catheter ( PIVC ) failure .


Secondary data analysis from a randomized controlled trial of PIVC dwell time .


The Prentice , Williams , and Peterson statistical model was used to identify and compare risk factors for phlebitis , occlusion , and accidental removal .


Three acute care hospitals in Queensland , Australia .


The trial included 3,283 adult medical and surgical patients ( 5,907 catheters ) with a PIVC with greater than 4 days of expected use .


Modifiable risk factors for occlusion included hand , antecubital fossa , or upper arm insertion compared with forearm ( hazard ratio [ HR ] , 1.47 [ 95 % confidence interval ( CI ) , 1.28-1 .68 ] , 1.27 [ 95 % CI , 1.08-1 .49 ] , and 1.25 [ 95 % CI , 1.04-1 .50 ] , respectively ) ; and for phlebitis , larger diameter PIVC ( HR , 1.48 [ 95 % CI , 1.08-2 .03 ] ) .


PIVCs inserted by the operating and radiology suite staff had lower occlusion risk than ward insertions ( HR , 0.80 [ 95 % CI , 0.67-0 .94 ] ) .


Modifiable risks for accidental removal included hand or antecubital fossa insertion compared with forearm ( HR , 2.45 [ 95 % CI , 1.93-3 .10 ] and 1.65 [ 95 % CI , 1.23-2 .22 ] , respectively ) , clinical staff insertion compared with intravenous service ( HR , 1.69 [ 95 % CI , 1.30-2 .20 ] ) ; and smaller PIVC diameter ( HR , 1.29 [ 95 % CI , 1.02-1 .61 ] ) .


Female sex was a nonmodifiable factor associated with an increased risk of both phlebitis ( HR , 1.64 [ 95 % CI , 1.28-2 .09 ] ) and occlusion ( HR , 1.44 [ 95 % CI , 1.30-1 .61 ] ) .


PIVC survival is improved by preferential forearm insertion , selection of appropriate PIVC diameter , and insertion by intravenous teams and other specialists .


The original randomized controlled trial on which this secondary analysis is based is registered with the Australian New Zealand Clinical Trials Registry ( http://www.anzctr.org.au; ACTRN12608000445370 ) .


To compare the differences in the clinical efficacy between Guan 's quadruple therapy for kidney disease and the conventional western medication in the treatment of chronic renal failure ( CRF ) .


Eighty patients were randomized into an observation group and a control group , 40 cases in each one .


In the observation group , besides the physician instruction of low protein and low phosphorus diet in the two groups , Guan 's quadruple therapy for kidney disease was applied , including ( 1 ) the isolated herbal moxibustion at Shenshu ( BL 23 ) and Pishu ( BL 21 ) , or Ganshu ( BL 18 ) , Zusanli ( ST 36 ) and Guanyuan ( CV 4 ) alternatively ; ( 2 ) acupuncture at the auricular points such as shen ( CO10 ) , jiaogan ( AHR6 ) , Shenshangxian ( TG2 ) , fei ( CO14 ) and pizhixia ( AT4 ) ; ( 3 ) injection of mixture of astragalus injection and lidocaine injection at Feishu ( BL 13 ) , Pishu ( BL 21 ) , Shenshu ( BL 23 ) and the others ; ( 4 ) modified Shenshuai Yihao decoction according to syndrome differentiation .


In the control group , the conventional western medication was used .


After 6 months of treatment , the differences were observed between the two groups in the clinical efficacy , serum creatinine ( Scr ) , blood urea nitrogen ( BUN ) , endogenous creatinine ( Ccr ) and 24 h urine protein quantitation ( UPQ ) .


In the observation group , after treatment , the remarkably effective rate was 50.0 % ( 20/40 ) and the total effective rate was 82.5 % ( 33/40 ) , which were superior to 25.0 % ( 10/40 ) and 45.0 % ( 18/40 ) in the control group ( both P < 0.05 ) .


After treatment , the levels of Scr , BUN and 24 h UPQ were reduced apparently ( all P < 0.05 ) , and the level of Ccr was increased apparently in the two groups ( both P < 0.05 ) .


After treatment , the levels of Scr , BUN and 24 h UPQ were reduced much more apparently in the observation group as compared with those in the control group ( all P < 0.05 ) .


Guan 's quadruple therapy for kidney disease achieves a better efficacy on CRF compared with the conventional western medication .


This therapy improves renal functions , relieves clinical symptoms and physical signs and benefits the life quality of patients .


The topical gel known as `` ABH gel , '' comprising lorazepam ( Ativan ( ) ) , diphenhydramine ( Benadryl ( ) ) , and haloperidol ( Haldol ( ) ) , is frequently used to treat nausea because of its perceived efficacy , relatively low cost , and ease of use in the home setting .


There are limited scientific data on this medication , however .


Recent pilot studies showed no absorption of the active ingredients of the gel , prompting further prospective studies into the cause of the perceived efficacy in the clinical setting .


To determine any difference in the effectiveness of ABH gel compared with placebo in cancer patients with nausea .


A randomized , double-blind , placebo-controlled , crossover , noninferiority clinical trial was developed to test the hypothesis that there is no difference in the effectiveness of ABH gel compared with placebo in cancer patients with nausea .


The primary outcome was the difference in nausea score ( on a 0-10 scale ) at baseline and at 60 minutes in each treatment group .


The difference in the ABH gel-treated group compared with placebo was evaluated for noninferiority .


Secondary outcomes included the number of vomiting episodes and side effects over time .


The mean change in nausea score from baseline to 60 minutes after treatment in the ABH gel group was 1.7 2.05 and 0.9 2.45 for the placebo group ( P = 0.42 ) .


The placebo group was found to be noninferior to the ABH gel group in reducing the nausea score .


ABH gel also did not decrease vomiting events better than placebo ( P = 0.34 ) .


Only one patient reported any side effects from the treatments in either arm of the study .


ABH gel in its current formulation should not be used in cancer patients experiencing nausea .


Irritable bowel syndrome ( IBS ) is highly prevalent in young women under stressful conditions .


Cognitive behavioral therapy ( CBT ) has been known to be effective in treating IBS .


This study aimed to evaluate the clinical outcomes of CBT in female nursing students with IBS .


The primary outcome measure of the study was the Bowel Symptom Severity Scale-IBS version .


Ninety diagnosed participants were randomized to each group in a randomized pretest-post-test control group design .


The experimental group received an 8-week CBT intervention , and the control group received general information on IBS .


Bowel symptom severity , dysfunctional attitudes , and IBS-quality of life were assessed at baseline and after 8 , 16 , and 24 weeks .


Six experimental and eight control participants withdrew during the study because of various reasons .


Significant effects were found for bowel symptom severity ( frequency : P < 0.001 ; distress : P < 0.001 ; disability : P < 0.001 ) between the experimental ( n = 39 ) and the control ( n = 37 ) groups .


The overall IBS-quality of life improved over time in the CBT group ( P < 0.001 ) .


The CBT also showed the alleviation of dysphoria ( P = 0.010 ) , interference with activity ( P = 0.031 ) , and health worry ( P = 0.009 ) , and the improvement of body image ( P = 0.008 ) and relationships ( P = 0.041 ) compared with the control group .


CBT proved to be an effective intervention for improving the clinical states of IBS in young female nursing students .


This study was aimed to examine how well readers of newspapers understand cancer survival rate data , and the effect of this understanding on their behavioral intent .


We recruited 1950 persons who were 20 years old or older registered with a market research company .


Participants were randomly divided into 10 groups ; 9 were assigned one of nine newspaper articles , and the remaining group was assigned the excerpt of the official Association of Clinical Cancer Centers web pages .


The primary outcome was the proportion of respondents with ` sufficient understanding ' , who gave 70 % or more correct answers on a 10-item knowledge question .


The proportion of participants with sufficient understanding varied across the groups ( range : 0.8-22 .1 % , overall , P < 0.001 ) .


Only around 15 % of participants answered that they would consider other hospitals in a scenario where the only hospital in the participants ' area had a 5-year survival of 5 % or less , and answers did not significantly vary between groups ( range : 11.1-21 .0 % , overall P = 0.77 ) .


The level of understanding of cancer survival rate varied by variation in media reporting .


However , the effect of behavioral intent on hospital choice did not differ between articles .


UMIN CTR UMIN000004885 .


Color affects emotions , feelings , and behaviors .


We hypothesized that color used in self-monitoring of blood glucose ( SMBG ) is helpful for patients to recognize and act on their glucose levels to improve glycemic control .


Here , two color-indication methods , color record ( CR ) and color display ( CD ) , were independently compared for their effects on glycemic control in less frequently insulin-treated type 2 diabetes .


One hundred twenty outpatients were randomly allocated to four groups with 22 factorial design : CR or non-CR and CD or non-CD .


Blood glucose levels were recorded in red or blue pencil in the CR arm , and a red or blue indicator light on the SMBG meter was lit in the CD arm , under hyperglycemia or hypoglycemia , respectively .


The primary end point was difference in glycated hemoglobin ( HbA1c ) reduction in 24 weeks .


Secondary end points were self-management performance change and psychological state change .


HbA1c levels at 24 weeks were significantly decreased in the CR arm by -0.28 % but were increased by 0.03 % in the non-CR arm ( P = 0.044 ) .


In addition , diet and exercise scores were significantly improved in the CR arm compared with the non-CR arm .


The exercise score showed significant improvement in the CD arm compared with the non-CD arm but without a significant difference in HbA1c reduction .


Changes in psychological states were not altered between the arms .


CR has a favorable effect on self-management performance without any influence on psychological stress , resulting in improved glycemic control in type 2 diabetes patients using less frequent insulin injection .


Thus , active but not passive usage of color-indication methods by patients is important in successful SMBG .


During spinal anesthesia for cesarean delivery , phenylephrine can cause reflexive decreases in maternal heart rate and cardiac output .


Norepinephrine has weak - adrenergic receptor agonist activity in addition to potent - adrenergic receptor activity and therefore may be suitable for maintaining blood pressure with less negative effects on heart rate and cardiac output compared with phenylephrine .


In a randomized , double-blinded study , 104 healthy patients having cesarean delivery under spinal anesthesia were randomized to have systolic blood pressure maintained with a computer-controlled infusion of norepinephrine 5 g/ml or phenylephrine 100 g/ml .


The primary outcome compared was cardiac output .


Blood pressure heart rate and neonatal outcome were also compared .


Normalized cardiac output 5 min after induction was greater in the norepinephrine group versus the phenylephrine group ( median 102.7 % [ interquartile range , 94.3 to 116.7 % ] versus 93.8 % [ 85.0 to 103.1 % ] , P = 0.004 , median difference 9.8 % , 95 % CI of difference between medians 2.8 to 16.1 % ) .


From induction until uterine incision , for norepinephrine versus phenylephrine , systolic blood pressure and stroke volume were similar , heart rate and cardiac output were greater , systemic vascular resistance was lower , and the incidence of bradycardia was smaller .


Neonatal outcome was similar between groups .


When given by computer-controlled infusion during spinal anesthesia for cesarean delivery , norepinephrine was effective for maintaining blood pressure and was associated with greater heart rate and cardiac output compared with phenylephrine .


Further work would be of interest to confirm the safety and efficacy of norepinephrine as a vasopressor in obstetric patients .


Recent studies indicate that perioperative fluid restriction leads to better preserved clinical data as well as reduced complication rates .


This study aimed to determine the probable mechanism of fluid restriction influence on the complication rate of patients undergoing gastrointestinal surgery for malignancy .


Patients ( n = 174 ) undergoing restricted fluid regimen ( R group ) or standard fluid regimen ( S group ) were included in this prospective , randomized trial over 16 months .