During laparoscopic surgery , the mesh is generally fixed with staples or tissue glue .


However , staples often cause pain at the staple sites , and they can cause scarring of the abdominal wall , which can lead to chronic pain .


We designed a trial that aims to determine whether mesh fixation with glue might cause less postoperative pain than fixation with staples during a transabdominal preperitoneal patch plastic repair .


The TISTA trial is a prospective , randomized , controlled , single-center trial with a two-by-two parallel design .


All patients and outcome-assessors will be blinded to treatment allocations .


For eligibility , patients must be male , @ years old , and scheduled for laparoscopic repair of a primary inguinal hernia .


One group comprises patients with a unilateral inguinal hernia that will be randomized to receive mesh fixation with either tissue glue or staples .


The second group comprises patients with bilateral inguinal hernias .


They will be randomized to receive mesh fixation with tissue glue either on the right or the left side and with staples on the other side .


The primary endpoint will be pain under physical stress , measured at @ h after surgery .


Pain will be rated by the patient based on a numeric rating scale from @ to @ , where @ equals the worst pain imaginable .


A total of @ patients will be recruited ( @ patients with unilateral inguinal hernias and @ patients with bilateral hernias ) .


This number is estimated to provide @ % power for detecting a pain reduction of one point on a numeric rating scale , with a standard deviation of one .


Patients with bilateral hernias will receive two meshes , one fixed with glue , and the other fixed with staples .


This design will eliminate the inter-individual bias inherent in comparing pain measurements between two groups of patients .


To examine the impact of providing fertility information on personal levels of fertility knowledge and intentions to delay childbearing .


Participants ( n = @ young childless women ) were randomly assigned to either an experimental ( fertility-related ) or control ( alcohol-related ) informational intervention group .


Subsequent to the exposure to information , participants completed a questionnaire measuring fertility knowledge and intentions for reproduction .


We predicted that the provision of fertility-related information would result in greater fertility knowledge and less intention to delay childbearing among young childless women .


The young women exposed to the brief fertility information intervention were significantly more likely to respond correctly to questions testing their fertility knowledge , and reported less intention to delay childbearing than the young women in the control group .


This study provided evidence that providing fertility-related information contributes to greater reproductive knowledge and may affect childbearing intentions .


Future research is warranted to examine the influence of fertility information on reproductive decision-making within a theoretical framework in order to ensure that subsequent information interventions maximize their effectiveness .


Operators who extract cardiac devices are exposed to considerable irradiation and excess risk of radiation-induced disorders .


A dedicated radioprotection cabin was developed to offer complete protection against radiation .


This randomized study was designed to ascertain the protection against radiation conferred by a radioprotection cabin and the safety during extraction of cardiac devices .


Thirty-seven consecutive patients who presented with an indication for extraction of a cardiac device were randomly assigned to a standard extraction technique ( n = @ ) , vs extraction with the use of a radiation protection cabin ( n = @ ) .


Fluoroscopic exposure was compared using electronic dosimeters placed on the thorax , back , foot , and head of the operator .


The procedural times and total fluoroscopic exposure times and the complication rates were not significantly different between the @ groups .


The mean dose of radiation delivered to the thorax and back was similar in both groups ( P = @ and P = @ , respectively ) .


In contrast , the mean doses of radiation delivered to the head and to the feet were respectively @ and @ times less in the cabin group than in the control group ( P < @ ) .


The cabin offers nearly full body radioprotection and eliminates the need to wear a lead apron , without increasing procedural time or complication rate during cardiac device extraction .


Previous research on the effects of plain packaging has largely relied on self-report measures .


Here we describe the protocol of a randomized controlled trial investigating the effect of the plain packaging of cigarettes on smoking behavior in a real-world setting .


In a parallel group randomization design , @ daily cigarette smokers ( @ % male , @ % female ) will attend an initial screening session and be assigned plain or branded packs of cigarettes to smoke for a full day .


Plain packs will be those currently used in Australia where plain packaging has been introduced , while branded packs will be those currently used in the United Kingdom .


Our primary study outcomes will be smoking behavior ( self-reported number of cigarettes smoked and volume of smoke inhaled per cigarette as measured using a smoking topography device ) .


Secondary outcomes measured pre - and post-intervention will be smoking urges , motivation to quit smoking , and perceived taste of the cigarettes .


Secondary outcomes measured post-intervention only will be experience of smoking from the cigarette pack , overall experience of smoking , attributes of the cigarette pack , perceptions of the on-packet health warnings , behavior changes , views on plain packaging , and the rewarding value of smoking .


Sex differences will be explored for all analyses .


This study is novel in its approach to assessing the impact of plain packaging on actual smoking behavior .


This research will help inform policymakers about the effectiveness of plain packaging as a tobacco control measure .


In European countries , including Switzerland , as well as in many states worldwide , cannabis is the most widely used psychoactive substance after alcohol and tobacco .


Although approximately one in ten users develop serious problems of dependency , only a minority attends outpatient addiction counseling centers .


The offer of a combined web-based self-help and chat counseling treatment could potentially also reach those users who hesitate to approach such treatment centers and help them to reduce their cannabis use .


This paper presents the protocol for a three-armed randomized controlled trial that will test the effectiveness of a web-based self-help intervention in combination with , or independent of , tailored chat counseling compared to a waiting list in reducing or enabling the abstention from cannabis use in problematic users .


The primary outcome will be the weekly quantity of cannabis used .


Secondary outcome measures will include the number of days per week on which cannabis is used , the severity of cannabis use disorder , the severity of cannabis dependence , cannabis withdrawal symptoms , cannabis craving , the use of alcohol , tobacco , and other non-cannabis illicit drugs , changes in mental health symptoms , and treatment retention .


The self-help intervention will consist of @ modules designed to reduce cannabis use based on the principles of motivational interviewing , self-control practices , and methods of cognitive behavioral therapy .


The two additional individual chat-counseling sessions in the additional chat condition will be based on the same therapy approaches and tailored to participants ' self-help information data and personal problems .


The predictive validity of participants ' baseline characteristics on treatment retention and outcomes will be explored .


To the best of our knowledge , this will be the first randomized controlled trial to test the effectiveness of online self-help therapy in combination or without chat counseling in reducing or enabling the abstention from cannabis use .


It will also investigate predictors of outcome and retention for these interventions .


This trial is registered at Current Controlled Trials and is traceable as ISRCTN@ .


Hypertrophic cardiomyopathy ( HCM ) is the most common cause of sudden death in the young , although not all patients eligible for sudden death prevention with an implantable cardioverter-defibrillator are identified .


Contrast-enhanced cardiovascular magnetic resonance with late gadolinium enhancement ( LGE ) has emerged as an in vivo marker of myocardial fibrosis , although its role in stratifying sudden death risk in subgroups of HCM patients remains incompletely understood .


We assessed the relation between LGE and cardiovascular outcomes in @ HCM patients referred for cardiovascular magnetic resonance and followed up for a median of @ years .


Sudden cardiac death ( SCD ) events ( including appropriate defibrillator interventions ) occurred in @ patients ( @ % ) .


A continuous relationship was evident between LGE by percent left ventricular mass and SCD event risk in HCM patients ( P = @ ) .


Extent of LGE was associated with an increased risk of SCD events ( adjusted hazard ratio , @ / @ % increase in LGE ; P = @ ) , even after adjustment for other relevant disease variables .


LGE of @ % of LV mass demonstrated a @-fold increase in SCD event risk in those patients otherwise considered to be at lower risk , with an estimated likelihood for SCD events of @ % at @ years .


Performance of the SCD event risk model was enhanced by LGE ( net reclassification index , @ % ; @ % confidence interval , @-@ @ ) .


Absence of LGE was associated with lower risk for SCD events ( adjusted hazard ratio , @ ; P = @ ) .


Extent of LGE also predicted the development of end-stage HCM with systolic dysfunction ( adjusted hazard ratio , @ / @ % increase in LGE ; P < @ ) .


Extensive LGE measured by quantitative contrast enhanced CMR provides additional information for assessing SCD event risk among HCM patients , particularly patients otherwise judged to be at low risk .


To determine whether umbilical cord milking ( UCM ) improves systemic blood flow and reduces neonatal morbidities compared with immediate cord clamping ( ICC ) .


Women admitted to a tertiary care center and delivering before @ weeks ' gestation were randomized to receive UCM or ICC .


Three blinded serial echocardiograms were performed in the first @ days of the infant 's life .


The primary outcome was measured systemic blood flow ( superior vena cava flow ) at each time point .


Of the @ neonates who were enrolled and randomized , @ were assigned to cord milking and @ to ICC .


Neonates randomized to cord milking had greater measures of superior vena cava flow and right ventricular output in the first @ hours and @ hours of life .


Neonates receiving UCM also had greater serum hemoglobin , received fewer blood transfusions , fewer days on oxygen therapy , and less frequent use of oxygen at @ weeks ' corrected postmenstrual age .


We demonstrate greater systemic blood flow with UCM in preterm neonates compared with ICC .


Future large prospective trials are needed to determine whether UCM reduces intraventricular hemorrhage and other long-term morbidities .


The use of ablative lasers based on the fractional approach is a novel strategy for the treatment of postoperative and acne scars in addition to wrinkles .


To evaluate and compare the efficacy of carbon dioxide ablative fractional laser ( AFL ) and the pulsed dye laser ( PDL ) for the improvement of surgical scars .


Fourteen Korean patients with surgical scars were enrolled for this study .


Half of each scar was treated with a @,@-nm AFL and the contralateral half with the @-nm PDL .


For early intervention of the postoperative scar , the laser treatments were begun after @ weeks from the Mohs micrographic surgery .


Both PDL and AFL produced statistically significant improvements .


However , comparatively , there was no statistical difference between them .


In each variable , AFL was more effective than PDL in the improvement of pliability and thickness .


In contrast , PDL was superior to AFL in the improvement of vascularity and pigmentation .


Pulsed dye laser and AFL treatments for surgical scar provide significant improvement .


Pulsed dye laser was more effective in color of scar compared with AFL , which showed marked improvement in the contour of scar .


Overall improvement was not statistically different in the Vancouver Scar Scale .


Ivacaftor has shown a clinical benefit in patients with cystic fibrosis who have the G@D-CFTR mutation and reduced lung function .


Lung clearance index ( LCI ) using multiple-breath washout might be an alternative to and more sensitive method than forced expiratory volume in @ s ( FEV@ ) to assess treatment response in the growing number of children and young adults with cystic fibrosis who have normal spirometry .


The aim of the study was to assess the treatment effects of ivacaftor on LCI in patients with cystic fibrosis , a G@D-CFTR mutation , and an FEV@ > @ % predicted .


This phase @ , multicentre , placebo-controlled , double-blind @ crossover study of ivacaftor treatment was conducted in patients with cystic fibrosis , at least one G@D-CFTR allele , and an FEV@ > @ % predicted .


Patients also had to have an LCI higher than @ at screening , age of @ years or older , and a weight higher than or equal to @ kg .


Eligible patients were randomly allocated to receive one of two treatment sequences ( placebo first followed by ivacaftor @ mg twice daily -LSB- sequence @ -RSB- or ivacaftor @ mg twice daily first followed by placebo -LSB- sequence @ -RSB- ) of @ days ' treatment in each period , with a @-day washout between the two treatment periods .


Randomisation ( ratio @:@ ) was done with block sizes of @ , and all site personnel including the investigator , the study monitor , and the Vertex study team were masked to treatment assignment .


The primary outcome measure was change from baseline in LCI .


The study is registered at ClinicalTrials.gov , NCT@ .


Between February and November , @ , @ patients were enrolled , of which @ were assigned to the sequence @ group , and @ to the sequence @ group .


@ of these patients received treatment and @ completed the trial ( eight in sequence @ group and @ in sequence @ group ) .


Treatment with ivacaftor led to significant improvements compared with placebo in LCI ( difference between groups in the average of mean changes from baseline at days @ and @ was -@ -LSB- @ % CI -@ to -@ -RSB- ; p < @ ) .


Adverse events experienced by study participants were similar between treatment groups ; at least one adverse event was reported by @ ( @ % ) of @ patients who received placebo and @ ( @ % ) of @ patients who received ivacaftor .


No deaths occurred during study period .


In patients with cystic fibrosis aged @ years or older who have at least one G@D-CFTR allele , ivacaftor led to improvements in LCI .


LCI might be a more sensitive alternative to FEV@ in detecting response to intervention in these patients with mild lung disease .


In elderly persons frailty and malnutrition are very common and can lead to serious health hazards such as increased mortality , morbidity , dependency , institutionalization and a reduced quality of life .


In Austria , the prevalence of frailty and malnutrition are increasing steadily and are becoming a challenge for our social system .


Physical training and adequate nutrition may improve this situation .


In this randomized controlled trial , @ malnourished frail community-dwelling patients ( @ years ) hospitalized at wards for internal medicine are recruited .


Additionally , @ lay volunteers ( @ years ) , named buddies are recruited and subsequently trained regarding health enhancing physical activity and nutrition in four standardized training sessions .


These buddies visit the malnourished frail persons at home twice a week for about one hour during an initial period of @-@ weeks .


While participants allocated to the intervention group ( n = @ ) receive intervention to improve their fluid intake , protein and energy intake , perform strength training and try to increase their baseline activities , the control group ( n = @ ) only gets home visits without any intervention .


After @-@ weeks , both , the intervention and the control group , receive the nutritional intervention and the physical training .


Health , nutritional and frailty status , physical fitness , body composition and chronic inflammation of buddies and frail persons are recorded before the intervention , after @-@ weeks , @ and @ months .


To your knowledge this trial is the first of its kind to provide nutritional and physical activity interventions to malnourished frail community-dwelling persons by trained lay buddies , in which an improvement of the frail persons ' and the buddies ' health status is measured .


This study assesses the efficacy of such an intervention and may offer new perspectives for the management of frailty and malnutrition .


Hypertension remains a significant risk factor in cardiovascular morbidity and mortality .


The purpose of the present study was to investigate the effects of @ weeks interval training programme on blood pressure , aerobic capacity ( VO max ) , indices of adiposity and marker of inflammation in black African men with essential hypertension .


Two hundred and forty five ( @ ) male subjects with stage @ and @ ( systolic blood pressure -LSB- SBP -RSB- between @-@ & diastolic blood pressure -LSB- DBP -RSB- between @-@ mmHg ) essential hypertension were age matched and grouped into experimental and control groups .


The experimental ( n = @ ; @ @ years ) group involved in an @ weeks interval training ( @-@ % HRmax ) programme of between @ and @ minutes , while age-matched control hypertensive ( n = @ ; @ years ) group remain sedentary during this period .


All subjects in both groups were on antihypertensive drugs throughout the study period .


Cardiovascular parameters ( SBP , DBP ) & VO max and percent body fat -LSB- % BF -RSB- , waist to hip ratio -LSB- WHR -RSB- and C-reactive protein -LSB- CRP -RSB- were assessed .


Independent t-test and Pearson correlation test were used in data analysis .


Findings of the study revealed significant decreased effects of interval training programme on SBP , DBP , % BF , WHR and CRP and significant increased effect on VO max at p < @ .


Also , changes in CRP as a result of exercise training significantly and positively correlated with changes in SBP , DBP , % BF , WHR , CRP and negatively correlated with VO max at p < @ .


This article provides a description of the rationale , design , and methods of a multisite clinical trial which evaluates the potential benefits of an evidence-based psychosocial treatment , STAIR Narrative Therapy , among women with posttraumatic stress disorder ( PTSD ) related to interpersonal violence who are seeking services in public sector community mental health clinics .


This is the first large multisite trial of an evidence-based treatment for PTSD provided in the context of community settings that are dedicated to the treatment of poverty-level patient populations .


The study is enrolling @ participants in a minimum of @ community clinics .


Participants are randomized into either STAIR Narrative Therapy or Treatment As Usual ( TAU ) .


Primary outcomes are PTSD , emotion management and interpersonal problems .


The study will allow a flexible application of the protocol determined by patient need and preferences .


Secondary analyses will assess the relationship of outcomes to different patterns of treatment implementation for different levels of baseline symptom severity .


The article discusses the rationale and study issues related to the use of a flexible delivery of a protocol treatment and of the selection of treatment as it is actually practiced in the community as the comparator .


To assess the effect of provision of free glasses on academic performance in rural Chinese children with myopia .


Cluster randomized , investigator masked , controlled trial .


@ primary schools in two prefectures in western China , @-@ .


@ of @,@ children in fourth and fifth grades ( mean age @ years ) with visual acuity < @/@ in either eye without glasses correctable to > @/@ with glasses .


@ ( @ % ) completed the study .


Children were randomized by school ( @ schools per arm ) to one of three interventions at the beginning of the school year : prescription for glasses only ( control group ) , vouchers for free glasses at a local facility , or free glasses provided in class .


Spectacle wear at endline examination and end of year score on a specially designed mathematics test , adjusted for baseline score and expressed in standard deviations .


Among @ eligible children , @ ( @ % ) were randomized to control , @ ( @ % ) to vouchers , and @ ( @ % ) to free glasses in class .


All eligible children would benefit from glasses , but only @ % wore them at baseline .


At closeout glasses wear was @ % ( observed ) and @ % ( self reported ) in the free glasses group , and @ % ( observed ) and @ % ( self reported ) in the controls .


Effect on test score was @ SD ( @ % confidence interval @ to @ ) when the free glasses group was compared with the control group .


The adjusted effect of providing free glasses ( @ , @ to @ ) was greater than parental education ( @ , -@ to @ ) or family wealth ( @ , -@ to @ ) .


This difference between groups was significant , but was smaller than the prespecified @ SD difference that the study was powered to detect .


The provision of free glasses to Chinese children with myopia improves children 's performance on mathematics testing to a statistically significant degree , despite imperfect compliance , although the observed difference between groups was smaller than the study was originally designed to detect .


Myopia is common and rarely corrected in this setting.Trial Registration Current Controlled Trials ISRCTN@ .


We designed and evaluated for feasibility an intervention-Yo Puedo-that addresses social network influences and socioeconomic opportunities in a neighborhood with substantial gang exposure and early childbearing .


Yo Puedo combined conditional cash transfers for completion of educational and reproductive health wellness goals with life skills sessions , and targeted youth @-@ years of age and same-aged members of their social network .


We conducted a two-arm study with social networks randomized to the intervention or a standard services control arm .


We evaluated intervention uptake , adherence , and safety ; and assessed evidence of effects on behavioral outcomes associated with unintended pregnancy and sexually transmitted infection risk .


A total of @ social networks composed of @ youth enrolled , with @ % retention over @ months .


Seventy-two percent of youth randomized to the intervention participated in intervention activities : @ % received at least one conditional cash transfer payment and @ % came to at least one life skills session .


We found no evidence that cash payments financed illicit or high-risk behavior .


At @ months , compared with controls , intervention participants had a lower odds of hanging out on the street frequently ( odds ratio -LSB- OR -RSB- , @ ; p = @ ) and a lower odds of reporting that their close friends had been incarcerated ( OR , @ ; p = @ ) .


They reported less regular alcohol use ( OR , @ ; p = @ ) and a lower odds of having sex ( OR , @ ; p = @ ) .


The feasibility evaluation of Yo Puedo demonstrated its promise ; a larger evaluation of effects on pregnancy and sustained behavioral changes is warranted .


To investigate the prognostic value of electrodiagnostic testing in patients with sciatica receiving physical therapy .


Electrodiagnostic testing was performed on @ patients with sciatica participating in a randomized trial comparing different physical therapy interventions .


Patients were grouped and analyzed according to the presence or absence of radiculopathy based on electrodiagnostic testing .


Longitudinal data analysis was conducted using multilevel growth modeling with ten waves of data collected from baseline through the treatment and post-treatment periods up to @ months .


The primary outcome measure was changes in low back pain-related disability assessed using the Roland and Morris disability questionnaire ( RMDQ ) .


Patients with radiculopathy ( n = @ ) had statistically significant and clinically meaningful improvements in RMDQ scores at every post-treatment follow-up occasion regardless of treatment received .


The final multilevel growth model revealed improvements in RMDQ scores in patients with radiculopathy at the @-week ( -@ , @ % CI -@ to -@ ; P = @ ) and @-month ( -@ , @ % CI -@ to -@ ; P = @ ) follow-up occasions compared to patients without radiculopathy .


Treatment group was not a significant predictive factor at any follow-up occasion .


An interaction between electrodiagnostic status and time revealed faster weekly improvements in RMDQ scores in patients with radiculopathy at the @-week ( -@ , @ % CI -@ to -@ ; P = @ ) through the @-week ( -@ , @ % CI , -@ to -@ ; P = @ ) follow-up occasions compared to patients without radiculopathy .


The presence of lumbosacral radiculopathy identified with electrodiagnostic testing is a favorable prognostic factor for recovery in low back pain-related disability regardless of physical therapy treatment received .


Loss of mechanical tension appears to be the major factor underlying decreased collagen synthesis in aged skin .


Numerous in vitro studies have shown the impact of mechanical forces on fibroblasts through mechanotransduction , which consists of the conversion of mechanical signals to biochemical responses .


Such responses are characterized by the modulation of gene expression coding not only for extracellular matrix components ( collagens , elastin , etc. ) but also for degradation enzymes ( matrix metalloproteinases -LSB- MMPs -RSB- ) and their inhibitors ( tissue inhibitors of metalloproteinases -LSB- TIMPs -RSB- ) .


A new device providing a mechanical stimulation of the cutaneous and subcutaneous tissue has been used in a simple , blinded , controlled , and randomized study .


Thirty subjects ( aged between @ years and @ years ) , with clinical signs of skin sagging , were randomly assigned to have a treatment on hemiface .


After a total of @ sessions with Mcano-Stimulation , biopsies were performed on the treated side and control area for in vitro analysis ( dosage of hyaluronic acid , elastin , type I collagen , MMP@ ; equivalent dermis retraction ; GlaSbox ( ) ; n = @ ) and electron microscopy ( n = @ ) .


Furthermore , before and after the treatment , clinical evaluations and self-assessment questionnaire were done .


In vitro analysis showed increases in hyaluronic acid , elastin , type I collagen , and MMP@ content along with an improvement of the migratory capacity of the fibroblasts on the treated side .


Electron microscopy evaluations showed a clear dermal remodeling in relation with the activation of fibroblast activity .


A significant improvement of different clinical signs associated with skin aging and the satisfaction of the subjects were observed , correlated with an improvement of the sagging cheek .


Mcano-Stimulation is a noninvasive and safe technique delivered by flaps microbeats at various frequencies , which can significantly improve the skin trophicity .


Results observed with objective measurements , ie , in vitro assessments and electron microscopy , confirm the firming and restructuring effect clinically observed .


A double-blind RCT on the short-term efficacy of nicotine patches compared to placebo patches among Dutch adolescents was conducted .


The findings demonstrated that nicotine patches are efficacious for smoking cessation at end-of-treatment ; however , only in highly compliant participants .


We tested whether the effects of NRT also held in @ - ( T@ ) and @-month ( T@ ) follow-up assessments .


Adolescents aged @-@ years , who smoked at least seven cigarettes a day and who were motivated to quit smoking were recruited at school yards and randomly assigned to either a nicotine patch ( n = @ ) or a placebo patch ( n = @ ) condition according to a computer generated list .


Participants ( N = @ , age : @ @ years ) attended an information meeting followed by a @ - or @-week treatment .


Smoking cessation , compliance , and potential covariates were measured by means of online questionnaires .


Smoking cessation at T@ was biochemically validated by saliva cotinine .


At T@ , @ % and @ % of participants were abstinent in the nicotine and placebo patch groups , respectively .


At T@ , abstinence was @ % and @ % , respectively .


Intention-to-treat analyses showed no significant effects of NRT on abstinence rates at T@ ( OR = @ , @ % CI = @ , @ ) and validated abstinence rates at T@ ( OR = @ , @ % CI = @ , @ ) neither after considering compliance nor after adjusting for covariates .


NRT fails in helping adolescents quit smoking at @ - and @-month follow-ups .


This finding suggests that a more intensive approach is needed to assist youngsters in their quit attempts .


The aim of this exploratory randomised controlled trial ( RCT ) was to evaluate three different occupation-focused interventions for well older people by estimating effect sizes for leisure engagement and ability in activities of daily living ( ADL ) and thereby identifying the most effective interventions .


One hundred and seventy seven persons , @-@ years old , living alone and without home help , were randomized to a control group ( CG ) , an individual intervention ( IG ) , an activity group ( AG ) , and a one-meeting discussion group ( DG ) .


All interventions focused on occupational engagement and how persons can cope with age-related activity restrictions in order to enhance occupational engagement .


Data were collected by blinded research assistants at baseline , three , and @ months .


Ordinal outcome data were converted , using Rasch measurement methods , to linear measures of leisure engagement and ADL ability .


Standardized between-group effect sizes , Cohen 's d , were calculated .


While all groups showed a decline in leisure engagement and ADL over time , the IG and the DG were somewhat effective in minimizing the decline at both three and @ months .


However , the effect sizes were small .


The findings indicate that occupation-focused interventions intended to minimize a decline in leisure engagement and ADL were sufficiently promising to warrant their further research .


Atherosclerotic renal-artery stenosis is a common problem in the elderly .


Despite two randomized trials that did not show a benefit of renal-artery stenting with respect to kidney function , the usefulness of stenting for the prevention of major adverse renal and cardiovascular events is uncertain .


We randomly assigned @ participants who had atherosclerotic renal-artery stenosis and either systolic hypertension while taking two or more antihypertensive drugs or chronic kidney disease to medical therapy plus renal-artery stenting or medical therapy alone .


Participants were followed for the occurrence of adverse cardiovascular and renal events ( a composite end point of death from cardiovascular or renal causes , myocardial infarction , stroke , hospitalization for congestive heart failure , progressive renal insufficiency , or the need for renal-replacement therapy ) .


Over a median follow-up period of @ months ( interquartile range , @ to @ ) , the rate of the primary composite end point did not differ significantly between participants who underwent stenting in addition to receiving medical therapy and those who received medical therapy alone ( @ % and @ % , respectively ; hazard ratio with stenting , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ) .


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


During follow-up , there was a consistent modest difference in systolic blood pressure favoring the stent group ( -@ mm Hg ; @ % CI , -@ to -@ ; P = @ ) .


Renal-artery stenting did not confer a significant benefit with respect to the prevention of clinical events when added to comprehensive , multifactorial medical therapy in people with atherosclerotic renal-artery stenosis and hypertension or chronic kidney disease .


( Funded by the National Heart , Lung and Blood Institute and others ; ClinicalTrials.gov number , NCT@ . )


Long-acting @-agonists and leukotriene receptor antagonists are two principal agents that can be added to inhaled corticosteroids ( ICS ) for patients with asthma that is not adequately controlled by ICS alone .


The Gly@Arg genotype of the @-adrenergic receptor ( ADRB@ ) gene may influence the bronchodilator effects of @-agonists .


We hypothesized that differential responses to long-acting @-agonists or leukotriene receptor antagonists might be determined partly by the Gly@Arg polymorphism in Japanese asthma patients .


This randomized , genotype-stratified , two-period crossover study included @ patients with mild-to-moderate asthma ( @ Arg/Arg and @ Gly/Gly individuals ) .


The primary study outcome was the difference in peak expiratory flow ( PEF ) ( PEF , l/min ) by genotype after @ weeks of treatment with salmeterol ( PEFsal ) or montelukast ( PEFmon ) .


In addition , multivariate analyses were used to identify independent factors that were predictive of responses to each treatment .


The mean PEFsal-PEFmon was @ among Arg/Arg individuals and @ among Gly/Gly individuals , indicating that the Gly@Arg genotype did not influence the differential bronchodilator effect of the two agents .


Multivariate analysis showed that higher peripheral eosinophil counts were associated with better response to salmeterol ( P < @ ) .


The Gly@Arg genotype did not influence the differential bronchodilator effect of salmeterol or montelukast as an add-on therapy to ICS within @ weeks of follow-up .


Higher peripheral eosinophil counts may be associated with better responses to salmeterol in combination with ICS .


To evaluate knowledge uptake from a parent-directed factsheet about managing pain during infant vaccinations , and the added influence of a pretest .


Solomon @-group randomized controlled trial .


New mothers hospitalized after the birth of an infant were randomized to @ of @ groups : @ included the intervention ( factsheet about pain management ) and @ included the control ( information on another topic ) .


A pretest was given to @ intervention and @ control group .


Following maternal review of allocated information , posttests were administered in all groups .


Both control groups received the information after posttesting .


A follow-up telephone survey after @ months measured knowledge retention and utilization of pain management interventions .


A total of @ mothers participated ( July , @ to February , @ ) ; demographics did not differ among groups .


The @ factsheet groups demonstrated more knowledge ( P < @ ) about effective pain management ( mean without pretest : @ -LSB- SD = @ -RSB- ; with pretest : @ -LSB- @ -RSB- ) compared with the @ control groups ( without pretest : @ -LSB- @ -RSB- ; with pretest : @ -LSB- @ -RSB- ) immediately after review ; and the factsheet and pretest group scored higher than the factsheet only group .


In groups with a prefactsheet baseline knowledge test , knowledge was higher at follow-up compared with baseline .


Follow-up knowledge and utilization of pain management interventions did not differ among groups .


The factsheet led to acute gains in knowledge and knowledge gains persisted after @ months .


Acutely , knowledge was bolstered by the pretest .


These results can be used to guide future research and implementation of the factsheet .


This study investigated if a process-oriented training for health professionals will influence women 's use and reasons for using a nipple shield , the baby 's weight , and the duration of breastfeeding .


An intervention was performed for health professionals that included a process-oriented training program on breastfeeding support .


Primiparas living in either the intervention municipality or in a control municipality were asked to participate in a longitudinal study to evaluate the care given .


Data collection for control group A ( CGA ) ( n = @ ) started before the intervention was initiated .


Data for control group B ( CGB ) ( n = @ ) were collected simultaneously with those for the intervention group ( IG ) ( n = @ ) .


The mothers responded to questionnaires at @ days , at @ months , and at @ months postpartum .


The mothers ' use of nipple shields related to the finding that if the women had a higher body mass index in the beginning of the pregnancy , the babies had difficulty in grasping over the nipple , and the mothers had pain or wound on the nipple .


For the mothers in the IG group , there was no significant difference if they had used nipple shields or not in relation to breastfeeding duration .


In contrast , the mothers in the control groups had a significant shorter breastfeeding duration if they had used nipple shields .


In the IG , there were no significant difference between the use of nipple shields and the babies ' weights at @ or @ months .


The babies of women in the CGB who used nipple shields had a significantly lower weight at @ months than the babies of those who did not use nipple shields ( p = @ ) .


A process-oriented training in breastfeeding counseling prolongs the duration of breastfeeding for women with breastfeeding problems , where the problems are remedied by the use of nipple shields .


Although radiotherapy ( RT ) provides potential benefits for patients with hepatocellular carcinomas ( HCCs ) that are unsuitable for operation , the specific role of adjuvant RT in HCC after hepatectomy remains ill defined .


The current study 's aim was to evaluate the safety and efficacy of adjuvant RT for centrally located HCCs after narrow-margin ( < @ cm ) hepatectomy .


The study included @ patients with centrally located HCCs who underwent narrow-margin hepatectomy between July @ and March @ .


Patients were prospectively randomized to receive adjuvant RT ( n = @ ) or were assigned to a control group ( n = @ ) .


Surgical outcomes , safety , and survival rates were evaluated .


Hepatectomy was successfully performed in all patients .


No cases of radiation-induced liver disease were observed .


One - , @ - , and @-year recurrence-free survival rates were @ % , @ % , and @ % in the adjuvant RT group and @ % , @ % , and @ % in the control group , respectively ( p = @ , log-rank test ) .


Corresponding overall survival rates were @ % , @ % , @ % , and @ % , @ % , @ % , respectively ( p = @ , log-rank test ) .


One - , @ - , and @-year recurrence-free survival rates in patients with small-diameter tumors ( @ cm ) were @ % , @ % , @ % in the adjuvant RT group and @ % , @ % , @ % in the control group ( p = @ , log-rank test ) .


Adjuvant RT for centrally located HCCs after narrow-margin hepatectomy was technically feasible and relatively safe .


No significant between-group difference was observed in recurrence-free and overall survival .


The post-hoc subgroup comparison showed that adjuvant RT improved recurrence-free survival considerably , but not overall survival , in patients with small HCCs ( @ cm ) .


More in-depth studies are needed to validate this finding .


To explore the optimized rehabilitation program in the treatment of post-stroke hemiplegia at the recovery stage .


Based on the randomized controlled principle , @ patients were randomized into an rehabilita tion + massage group ( group A ) and an rehabilitation + acupuncture group ( group B ) , @ cases in each one .


Bobath sport therapy and functional training were adopted in the two groups .


In the group A , the massage therapy was added .


The rolling method and palm-rubbing method were used on the affected side , the pressing , kneading and plucking methods were applied to Jianliao ( LI @ ) , Jianzhen ( SI @ ) , Quchi ( LI @ ) , Huantiao ( GB @ ) , Weizhong ( BL @ ) , Chengshan ( BL @ ) , Zusanli ( ST @ ) and the other acu points ; and the nipping method was adopted at the twelve Jing-well points .


In the group B , acupuncture was applied to Baihui ( BL @ ) , Jianliao ( LI @ ) , Quchi ( LI @ ) , Shousanli ( LI @ ) , Huantiao ( GB @ ) , Yanglingquan ( GB @ ) , Jiexi ( ST @ ) and the other acupoints .


The treatment was given once a day , @ treatments a week in the two groups .


The efficacy was evaluated in @ weeks .


Fugl-Meyer scale , Barthel index ( BI ) score , modified Rankin scale and stroke-specific quality of life ( SS-QOL ) were used to assess the limb motor function , the activity of daily life ( ADL ) , independent activity of life and the quality of life of the patients in the two groups before and after treatment .


Based on the total cost and benefit , the health economics evaluation was conducted in the patients of the two groups .


The treatments all improved the limb motor function ( group A : @ ( @ ) vs @ ( @ ) ; group B : @ ( @ ) vs @ ( @ ) ) , the independent activity of life , ADL ( group A : @ + / - @ vs @ + / - @ ; group B : @ + / - @ vs @ + / - @ ) and the quality of life ( group A : @ + / - @ vs @ + / - @ ; group B : @ + / - @ vs @ + / - @ ) in the patients of the two groups .


The differences in all the indices were significant statistically before and after treatment in the two groups ( all P < @ ) .


Above indices after treatment were not different obviously between the two groups ( all P > @ ) .


In terms of health economics , the expense was decreased by RMB @ while BI was increased by every @ score in group A in comparison with the group B.


Both the rehabilitation and massage therapy and the rehabilitation and acupuncture therapy improve the limb motor function and the quality of life in the patients of post-stroke hemiplegia .


The therapeutic efficacies are similar between the two therapeutic programs .


The program of rehabilitation and massage is more economical in the aspects of ADL improvement , being advantageous at simple operation and low cost .


Too few young people engage in behaviours that reduce the risk of morbidity and premature mortality , such as eating healthily , being physically active , drinking sensibly and not smoking .


This study sought to assess the efficacy and cost-effectiveness of a theory-based online health behaviour intervention ( based on self-affirmation theory , the Theory of Planned Behaviour and implementation intentions ) targeting these behaviours in new university students , in comparison to a measurement-only control .


Two-weeks before starting university all incoming undergraduates at the University of Sheffield were invited to take part in a study of new students ' health behaviour .


A randomised controlled design , with a baseline questionnaire , and two follow-ups ( @ and @ months after starting university ) , was used to evaluate the intervention .


Primary outcomes were measures of the four health behaviours targeted by the intervention at @-month follow-up , i.e. , portions of fruit and vegetables , metabolic equivalent of tasks ( physical activity ) , units of alcohol , and smoking status .


The study recruited @,@ students ( intervention n = @ , control n = @ , @ % female , Mean age = @ years ) , of whom @,@ completed at least one follow-up ( @ % attrition ) .


The intervention had a statistically significant effect on one primary outcome , smoking status at @-month follow-up , with fewer smokers in the intervention arm ( @ % ) than in the control arm ( @ % ; Odds ratio = @ , p = @ ) .


There were no significant intervention effects on the other primary outcomes ( physical activity , alcohol or fruit and vegetable consumption ) at @-month follow-up .


The results of the RCT indicate that the online health behaviour intervention reduced smoking rates , but it had little effect on fruit and vegetable intake , physical activity or alcohol consumption , during the first six months at university .


However , engagement with the intervention was low .


Further research is needed before strong conclusions can be made regarding the likely effectiveness of the intervention to promote health lifestyle habits in new university students .


Frequent self-weighing is linked with weight management success , but concern has been raised about its possible association with unhealthy practices .


This study examined the association of self-weighing with other weight control behaviors in a sample for whom frequent weighing might be questioned -- namely , normal-weight or overweight ( BMI of @-@ @ ) young adults ( age @-@ ) .


Participants ( N = @ ; mean -LSB- SD -RSB- age = @ -LSB- @ -RSB- ; BMI = @ -LSB- @ -RSB- ) entering the Study of Novel Approaches to Weight Gain Prevention ( SNAP ) completed objective measures of weight and physical activity and self-reported weight history , use of healthy and unhealthy weight control strategies , depressive symptoms , and dietary intake .


Daily self-weighing was reported by @ % of participants , and @ % weighed several times per week .


Frequent weighing was not associated with current BMI , gender , or age but was associated with being further below one 's highest weight , history of dieting , and perceived difficulty maintaining weight .


Frequent weighing was associated with healthy weight management strategies , but not with unhealthy practices or depressive symptoms .


In this sample , frequent self-weighing appears to be part of a constellation of healthy weight control behaviors used to counteract a perceived tendency toward weight gain .


SNAP follow-up will determine whether frequent self-weighing helps prevent weight gain .


This prospective phase II study was designed to assess disease control and to describe acute and late adverse effects of treatment with proton radiotherapy in children with rhabdomyosarcoma ( RMS ) .


Fifty-seven patients with localized RMS ( age @ years or younger ) or metastatic embryonal RMS ( age @ to @ years ) were enrolled between February @ and August @ .


All patients were treated with chemotherapy based on either vincristine , actinomycin , and cyclophosphamide or vincristine , actinomycin , and ifosfamide-based chemotherapy and proton radiation .


Surgical resection was based on tumor site and accessibility .


Common Terminology Criteria for Adverse Events , Version @ , was used to assess and grade adverse effects of treatment .


Concurrent enrollment onto Children 's Oncology Group or European Pediatric Sarcoma Study Group protocols was allowed .


All pathology and imaging were reviewed at the treating institution .


Median follow-up was @ months ( range , @ to @ months ) for survivors .


Five-year event-free survival ( EFS ) , overall survival ( OS ) , and local control ( LC ) were @ % , @ % , and @ % , respectively , for the entire cohort .


The @-year LC by risk group was @ % for low-risk and @ % for intermediate-risk disease .


There were @ patients with grade @ acute toxicity and three patients with grade @ late toxicity .


There were no acute or late toxicities higher than grade @ .


Five-year LC , EFS , and OS rates were similar to those observed in comparable trials that used photon radiation .


Acute and late toxicity rates were favorable .


Proton radiation appears to represent a safe and effective radiation modality for pediatric RMS .


To compare the perioperative data , pathological results and functional outcomes of transvesical single - site laparoscopic radical prostatectomy ( TVSSLRP ) with those of nerve-sparing extraperitoneal laparoscopic radical prostatectomy ( nsELRP ) in the treatment of low-risk prostate cancer ( PCa ) .


Fifty patients with low-risk organ-confined PCa were randomly assigned to two groups of equal number to receive TVSSLRP and nsELRP , respectively .


Comparisons were made between the two groups of patients in such demographic and baseline data as age , comorbidity , body mass index ( BMI ) , serum prostate-specific antigen ( PSA ) , prostate volume , bioptic Gleason score , clinical stage , IIEF-@ score , nocturnal penile tumescence ( NPT ) , penile brachial index ( PBI ) , and penile arterial blood flow velocity as well as in such surgery-related parameters as operation duration , blood loss , blood transfusion , intraoperative complications , positive surgical margin , catheterization time , hospital stay , and postoperative Gleason score , pathologic stage , urinal pad use , PSA level , IIEF-@ score , NPT , PBI and PABFV .


All the operations were successfully performed .


There were no statistically significant differences between the two groups either in the demographic and baseline data or in intraoperative blood loss , blood transfusion rate , complications , and positive surgical margin .


No intraoperative complications and positive surgical margins were found in either group .


Compared with nsELRP , TVSSLRP achieved a significantly shorter operation duration ( -LSB- @ @ -RSB- min vs -LSB- @ @ -RSB- min , P < @ ) , catheterization time ( -LSB- @ @ -RSB- d vs -LSB- @ @ -RSB- d , P < @ ) , and hospital stay ( -LSB- @ @ -RSB- d vs -LSB- @ @ -RSB- d , P < @ ) .


On the first day and at @ , @ and @ months after catheter removal , the urinary continence rates in the TVSSLRP and nsELRP groups were @ % vs @ % ( P < @ ) , @ % vs @ % , @ % vs @ % , and @ % vs @ % , respectively ; and at @ , @ and @ months after surgery , the erectile potency rates were @ % vs @ % ( P < @ ) , @ % vs @ % , and @ % vs @ % , respectively , with an IIEF-@ score @ , all evidently higher in the TVSSLRP than in the nsELRP group .


The penile brachial index and arterial blood flow velocity of the two groups of patients exhibited no significant differences before and after surgery , nor did postoperative complications ( grade II ) between the TVSSLRP and nsELRP groups ( @ % vs @ % , P > @ ) .


The Gleason score and pathologic stage were increased after surgery , but with remarkable differences between the two groups ( P > @ ) .


No biochemical recurrence was found in either group during a @-month follow-up .


With the advantages of safety and rapid postoperative recovery , both TVSSLRP and nsELRP are feasible for the treatment of low-risk organ-confined PCa , but the former may achieve an earlier recovery of urinary continence and erectile function than the latter .


The objective of this study was to examine the associations between baseline electroencephalogram ( EEG ) - assessed brain oscillations and subsequent response to four neuromodulatory treatments .


Based on available research , we hypothesized that baseline theta oscillations would prospectively predict response to hypnotic analgesia .


Analyses involving other oscillations and the other treatments ( meditation , neurofeedback , and both active and sham transcranial direct current stimulation ) were viewed as exploratory , given the lack of previous research examining brain oscillations as predictors of response to these other treatments .


Randomized controlled study of single sessions of four neuromodulatory pain treatments and a control procedure .


Thirty individuals with spinal cord injury and chronic pain had their EEG recorded before each session of four active treatments ( hypnosis , meditation , EEG biofeedback , transcranial direct current stimulation ) and a control procedure ( sham transcranial direct stimulation ) .


As hypothesized , more presession theta power was associated with greater response to hypnotic analgesia .


In exploratory analyses , we found that less baseline alpha power predicted pain reduction with meditation .


The findings support the idea that different patients respond to different pain treatments and that between-person treatment response differences are related to brain states as measured by EEG .


The results have implications for the possibility of enhancing pain treatment response by either @ ) better patient/treatment matching or @ ) influencing brain activity before treatment is initiated in order to prepare patients to respond .


Research is needed to replicate and confirm the findings in additional samples of individuals with chronic pain .


The purpose of this study was to assess the efficacy of a @ week , self-managed , community-based stretching program on musculoskeletal fitness , musculoskeletal symptoms , and acculturative stress , in Korean-Chinese female migrant workers in Korea .


This was a randomized controlled trial with random assignment of eligible full-time Korean-Chinese female migrant workers to a stretching exercise intervention ( n = @ ) or an enhanced stretching exercise intervention ( n = @ ) condition .


Both conditions received a @ min stretching exercise program that included an orientation and three work-related musculoskeletal disorder ( WMSD ) educational classes .


Between educational classes , the enhanced stretching exercise condition also received mobile phone text messaging and telephone counseling to increase self-efficacy ( confidence in overcoming barriers ) and provide social support .


Flexibility , muscle strength , musculoskeletal symptoms , and acculturative stress were assessed at baseline and @ weeks .


Significant increase in flexibility was noted for both conditions , but acculturative stress was significantly reduced only in the standard intervention condition .


Muscle strength and WMSD symptoms had no significant changes at the @ week follow up in both conditions .


The @ week , self-managed , community-based , stretching exercise program was effective to increase flexibility .


The standard stretching intervention without any enhancements may be a more cost-effective way to increase flexibility .


Longitudinal studies , however , are needed to see if the long-term effects are greater in the enhanced intervention for the migrant worker population .


To determine the effects of Syndrome Differentiated Chinese Medicine ( TCM ) Therapy on ( CKD ) @-@ stage chronic kidney disease with proteinuria .


A prospective randomized control study was undertaken in @ centers .


A total of @ chronic nephritis patients were divided into a treatment group ( n = @ ) and a control group ( n = @ ) .


Their TCM syndrome was classified as `` Qi and Yin Deficiency of spleen and kidney '' or `` Qi and Yang Deficiency of spleen and kidney '' , with accompanying syndromes showing as `` water and dampness '' , `` damp-heat '' , and `` blood stasis '' .


Patients in the treatment group took a dose of Chinese medicine daily in response to their syndromes , while the controls took @ mg/d losartan .


The course of treatment was @ weeks .


Changes of @-hour urinary protein excretion and glomerular filtration rate ( eGFR ) before and after treatments ( @ , @ , @ , @ , @ , @ weeks ) , as well as clinical efficacy ( after @ , @ , @ weeks treatments ) were measured .


@ patients were included in the final program participants comply analysis ( PPS ) .


Patients in the treatment group showed gradual decreased @-hour urinary protein excretion , whereas the controls remained unchanged .


Significant differences in @-hour urinary protein excretion appeared between the experimental and control group at week @ and @ ( P < @ ) .


eGFR decreased in all of the patients after treatments ( P = @ ) .


At three follow-up points , patients in the treatment group had higher eGFR than the controls , but without statistical significance ( P > @ ) .


Significant differences in clinical remission rate , marked effect rate and total effective rate were observed between the treatment and control groups at week @ ( P < @ ) .


Syndrome differentiated TCM therapy can reduce the level of proteinuria in CKD @-@ nephritis patients , promoting clinical effectiveness and protecting renal functions .


To evaluate the effects of oral delayed-release dimethyl fumarate ( DMF ; also known as gastro-resistant DMF ) on MRI lesion activity and load , atrophy , and magnetization transfer ratio ( MTR ) measures from the Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis ( CONFIRM ) study .


CONFIRM was a @-year , placebo-controlled study of the efficacy and safety of DMF @ mg twice ( BID ) or @ times daily ( TID ) in @,@ patients with relapsing-remitting multiple sclerosis ( RRMS ) ; subcutaneous glatiramer acetate @ mg once daily was included as an active reference comparator .


The number and volume of T@-hyperintense , T@-hypointense , and gadolinium-enhancing ( Gd + ) lesions , as well as whole brain volume and MTR , were assessed in @ patients ( MRI cohort ) .


DMF BID and TID produced significant and consistent reductions vs placebo in the number of new or enlarging T@-hyperintense lesions and new nonenhancing T@-hypointense lesions after @ and @ years of treatment and in the number of Gd + lesions at week @ , year @ , and year @ .


Lesion volumes were also significantly reduced .


Reductions in brain atrophy and MTR changes with DMF relative to placebo did not reach statistical significance .


The robust effects on MRI active lesion counts and total lesion volume in patients with RRMS demonstrate the ability of DMF to exert beneficial effects on inflammatory lesion activity in multiple sclerosis , and support DMF therapy as a valuable new treatment option in RRMS .


This study provides Class I evidence of reduction in brain lesion number and volume , as assessed by MRI , over @ years of delayed-release DMF treatment .


Percutaneous vertebroplasty is a widely used vertebral augmentation procedure for treating osteoporotic vertebral compression fractures ( OVCFs ) .


But high cement leakage rate caused by a low-viscosity cement and high injection pressure has limited its general use .


Balloon kyphoplasty ( BKP ) and high-viscosity cement vertebroplasty ( HVCV ) are @ modifications of vertebroplasty designed to decrease cement leakage .


To assess the safety and efficacy of HVCV compared with BKP .


A prospective cohort study .


Department of Spine Surgery , an affiliated hospital of a medical university .


One hundred seven patients suffering from painful OVCFs were randomly assigned into HVCV or BKP groups .


Visual Analog Scale ( VAS ) , Oswestry Disability Index ( ODI ) , cement leakage , and vertebral height restoration were evaluated .


All occurring complications and injected cement volumes were recorded .


The follow-up time was one year .


VAS and ODI scores improved in both groups , and did not differ significantly between the @ groups .


More cement was used in the BKP group than in HVCV group ( @ vs. @ mL , P < @ ) .


The incidence of cement leakage in the HVCV group was lower than that of the BKP group ( @ % vs @ % , P < @ ) .


No symptomatic cement leakages occurred in the HVCV group .


In the BKP group , one patient experienced discogenic back pain related to a disc leak , and another patient had asymptomatic cement emboli in the lung related to venous leakage .


The mean compression rate before the procedure was @ % in the HVCV group and @ % in the BKP group ( P = @ ) .


The vertebral height was improved significantly and maintained at one-year follow-up in both groups .


BKP was more effective in vertebral height restoration than HVCV ( @ % vs. @ % , P < @ ) .


There was one case of a new adjacent vertebral fracture in the HVCV group ( @ % ) , and @ cases of new nonadjacent vertebral fractures in the BKP group ( @ % ) ( P = @ ) .


A single-center and relatively small-sample size study .


HVCV and BKP are safe and effective in improving quality of life and relieving pain .


HVCV has a lower cement leakage rate , whereas BKP is more effective in vertebral height restoration .


Subsequent fractures are not different between the @ groups .


This study aims to compare and evaluate the effect of adding ketamine as an adjunct to lidocaine for intravenous regional anesthesia ( IVRA ) on intraoperative and postoperative analgesia , the onset and recovery times of sensory and motor block , and tourniquet pain .


Forty patients undergoing surgery of the hand or forearm under IVRA were randomly assigned to receive lidocaine @ mg/kg ( group @ ) or lidocaine @ mg/kg plus ketamine @ mg ( group @ ) diluted to @ mL with normal saline .


Assessment parameters included the onset and recovery times of sensory and motor block , tourniquet pain , intraoperative hemodynamics , surgeon and patient satisfaction , postoperative pain , time of first analgesic request , total analgesic consumption , and adverse effects in the first @ hours postoperatively .


Groups @ and @ were comparable in demographic and surgical parameters .


There were no differences between groups in intraoperative hemodynamics , onset and recovery times of sensory and motor block , or surgeon satisfaction index .


Compared with group @ , group @ patients showed less tourniquet pain , prolonged time to first request for postoperative rescue analgesia ( @ @ vs @ @ hours , P < @ ) , lower postoperative diclofenac consumption ( @ @ vs @ @ mg , P < @ ) , lower scores for postoperative pain as measured by the Verbal Rating Scale , higher patient satisfaction index , and a nonsignificant difference in the incidence of postoperative adverse effects between groups .


The addition of ketamine to lidocaine in patients receiving IVRA significantly reduced intraoperative and postoperative analgesic requirements and improved patient satisfaction without causing significant adverse effects .


Antiretroviral pre-exposure prophylaxis ( PrEP ) , with daily oral tenofovir disoproxil fumarate or tenofovir disoproxil fumarate in combination with emtricitabine , has been shown to be efficacious for HIV-@ prevention .


Although the use of more than one antiretroviral agent is essential for effective HIV-@ treatment , more than one agent might not be required for effective prophylaxis .


We assessed the efficacy of single-agent tenofovir disoproxil fumarate relative to combination emtricitabine plus tenofovir disoproxil fumarate as PrEP .


We did a randomised , double-blind , placebo-controlled three-group phase @ trial of daily oral tenofovir disoproxil fumarate and emtricitabine plus tenofovir disoproxil fumarate PrEP in HIV-@ uninfected individuals in heterosexual HIV-@ serodiscordant couples from Kenya and Uganda .


After an interim review , the trial 's placebo group was discontinued and thereafter the active groups were continued , and participants initially randomly assigned to placebo were offered rerandomisation in a @:@ ratio to tenofovir disoproxil fumarate or emtricitabine plus tenofovir disoproxil fumarate as PrEP .


The primary endpoints were HIV-@ seroconversion and safety .


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


@ ( @ % ) of @ couples received tenofovir disoproxil fumarate or emtricitabine plus tenofovir disoproxil fumarate and were followed up for HIV-@ acquisition .


Of @ incident HIV-@ infections , @ occurred in individuals assigned tenofovir disoproxil fumarate ( incidence @ cases per @ person-years ) and @ were in those assigned emtricitabine plus tenofovir disoproxil fumarate ( @ cases per @ person-years ) ; HIV-@ incidence in the placebo group until discontinuation was two cases per @ person-years .


HIV-@ prevention efficacy with emtricitabine plus tenofovir disoproxil fumarate was not significantly different from that of tenofovir disoproxil fumarate alone ( hazard ratio -LSB- HR -RSB- @ , @ % CI @-@ ; p = @ ) .


Detection of tenofovir in plasma samples , compared with no detection and as measured in seroconverters and a subset of non-seroconverters , was associated with an @ % relative risk reduction in HIV-@ acquisition for the tenofovir disoproxil fumarate group ( HR @ , @ % CI @-@ ; p < @ ) and @ % for the emtricitabine plus tenofovir disoproxil fumarate group ( @ , @-@ ; p < @ ) .


No significant differences were noted in the frequency of deaths , serious adverse events , or serum creatinine and phosphorus abnormalities between the two groups .


These results do not rule out the potential for a slight difference in HIV-@ protection with tenofovir disoproxil fumarate compared with emtricitabine plus tenofovir disoproxil fumarate , but show that once-daily oral tenofovir disoproxil fumarate or emtricitabine plus tenofovir disoproxil fumarate regimens both provide high protection against HIV-@ acquisition in heterosexual men and women .


The safety of healthy volunteer donors is one of the most important issues in living-donor liver transplantation .


Use of the Pringle maneuver during donor hepatectomy can result in liver ischemia-reperfusion ( IR ) injury .


The objective of this study was to examine the effects of isoflurane and propofol on IR injury caused by the Pringle maneuver during donor hepatectomy .


A total of @ American Society of Anesthesiology I-II donors aged @-@ years who underwent hepatectomy were included in the study .


The patients were randomly divided into @ groups : propofol and isoflurane .


Plasma superoxide dismutase ( SOD ) , malondialdehyde ( MDA ) , total oxidative status ( TOS ) , total antioxidant capacity ( TAC ) , and oxidative stress index ( OSI ) were measured before surgery ( t@ ) and after surgery ( t@ ) .


There were no statistically significant differences in demographic features , anesthesia , and times of surgery between the groups ( P > @ ) .


Plasma TAC levels at t@ and t@ were significantly lower in the propofol group than in the isoflurane group ( P < @ ) .


OSI at t@ was significantly higher in the propofol group than in the isoflurane group ( P < @ ) .


MDA levels were significantly higher in the propofol group than in the isoflurane group at t@ ( P < @ ) .


MDA levels level were significantly higher in the isoflurane group than in the propofol group at t@ ( P < @ ) .


Propofol may have protective effects against IR injury caused by the Pringle maneuver during donor hepatectomy in living-donor transplantations .


However , the effectiveness of propofol for clinical use needs to be investigated further .


The aim of this study was to determine whether maternal vitamin supplementation affects long-term mortality and morbidity of children born to HIV-infected mothers .


In total , @ HIV-infected pregnant woman were enrolled in a double-blind , @ factorial , randomised , placebo-controlled trial in Tanzania .


Data were collected for @ children at monthly clinic visits through a median age of @ months .


Maternal receipt of multivitamins ( HR = @ ; @ % CI : @-@ @ ) or vitamin A ( HR = @ ; @ % CI : @-@ @ ) did not affect all-cause child mortality through age @ years .


Among HIV-negative children , maternal multivitamin supplementation was associated with a lower mortality rate up to @ years ( HR = @ ; @ % CI : @-@ @ ) , primarily in children < @ years of age .


Maternal vitamin A supplementation did not significantly affect child mortality up to @ years ( HR = @ ; @ % CI : @-@ @ ) .


Children born to mothers who received multivitamins had a lower risk of all types of diarrhoea ( RR = @ ; @ % CI : @-@ @ ) through @ years of age .


The reduced risk of watery diarrhoea persisted in children from @-@ years of age ( RR = @ ; @ % CI : @-@ @ ) .


Maternal vitamin supplementation during pregnancy and lactation may be associated with long-lasting affects in HIV-exposed children -LSB- ClinicalTrials.gov Identifier : NCT@ -RSB- .


To investigate staff and trainer perspectives on the barriers and facilitators to implementing a complex intervention to help staff support the recovery of service users with a primary diagnosis of psychosis in community mental health teams .


Process evaluation nested within a cluster randomised controlled trial ( RCT ) .


@ interviews with mental health care staff , @ interviews with trainers , @ focus groups with intervention teams and @ written trainer reports .


@ community-based mental health teams in two UK sites ( one urban , one semi-rural ) who received the intervention .


The factors influencing the implementation of the intervention can be organised under two over-arching themes : Organisational readiness for change and Training effectiveness .


Organisational readiness for change comprised three sub-themes : NHS Trust readiness ; Team readiness ; and Practitioner readiness .


Training effectiveness comprised three sub-themes : Engagement strategies ; Delivery style and Modelling recovery principles .


Three findings can inform future implementation and evaluation of complex interventions .


First , the underlying intervention model predicted that three areas would be important for changing practice : staff skill development ; intention to implement ; and actual implementation behaviour .


This study highlighted the importance of targeting the transition from practitioners ' intent to implement to actual implementation behaviour , using experiential learning and target setting .


Second , practitioners make inferences about organisational commitment by observing the allocation of resources , Knowledge Performance Indicators and service evaluation outcome measures .


These need to be aligned with recovery values , principles and practice .


Finally , we recommend the use of organisational readiness tools as an inclusion criteria for selecting both organisations and teams in cluster RCTs .


We believe this would maximise the likelihood of adequate implementation and hence reduce waste in research expenditure .


This study aimed to compare emergence agitation following sevoflurane and desflurane anaesthesia in adults undergoing orthognathic surgery .


The hypothesis was that there might be a difference in the incidence of emergence agitation following sevoflurane and desflurane anaesthesia considering the difference in blood solubility and speed of recovery between the two .


In this prospective randomised double-blind study , @ adults undergoing orthognathic surgery were randomly allocated to either sevoflurane or desflurane anaesthesia .


The incidence of emergence agitation and possible causative factors were then compared between the groups .


The incidence of emergence agitation was lower in the desflurane group than in the sevoflurane group ( @ % vs. @ % , P < @ ) .


In addition , the time intervals between the discontinuation of anaesthetics and the first response , extubation , and discharge from post-anaesthesia care unit were significantly shorter in the desflurane group ( P = @ , P < @ and P = @ , respectively ) .


The other variables were similar in the two groups .


In adults undergoing orthognathic surgery , desflurane anaesthesia was associated with less emergence agitation than was sevoflurane anaesthesia .


The aim of this study was to investigate the hypothesis that a novel biodegradable polymer-coated , cobalt-chromium ( CoCr ) , sirolimus-eluting stent ( BP-SES ) is noninferior in safety and efficacy outcomes compared with a durable polymer ( DP ) - SES .


No randomized trials have the compared safety and efficacy of BP-SES versus DP-SES on similar CoCr platforms , thereby isolating the effect of the polymer type .


In this prospective , single-blind , randomized trial conducted at @ Chinese sites , @,@ patients eligible for coronary stenting were treated with BP - or DP-SES in a @:@ ratio .


The primary endpoint was @-month target lesion failure ( TLF ) , a composite of cardiac death , target vessel myocardial infarction , or clinically indicated target lesion revascularization .


Secondary endpoints included TLF components , and definite/probable stent thrombosis .


At @ months , the difference in the primary endpoint of TLF between BP-SES ( @ % ) and DP-SES ( @ % ) groups was @ % ( @ % confidence interval : -@ % to @ % , p for noninferiority = @ ) , demonstrating noninferiority of BP-SES to DP-SES .


Individual TLF components of cardiac death ( @ % vs. @ % , p = @ ) , target vessel myocardial infarction ( @ % vs. @ % , p = @ ) , and clinically indicated target lesion revascularization ( @ % vs. @ % , p = @ ) were similar , as were low definite/probable stent thrombosis rates ( @ % vs. @ % , p = @ ) .


In this large-scale real-world trial , BP-SES was noninferior to DP-SES for @-year TLF .


( Evaluate Safety and Effectiveness of the Tivoli DES and the Firebird DES for Treatment of Coronary Revascularization ; NCT@ ) .


Tinnitus , a subjective auditory perception of sounds or noise not triggered by external auditory stimuli , carries considerable morbidity .


To date , pharmacological , physical or behavioral therapy is the mainstay of management .


We compared repetitive transcranial magnetic stimulation ( rTMS ) of @ or @ stimulations/day at @ Hz and @ % of the motor threshold for @ consecutive days over the left auditory cortex .


Ratings based on the Tinnitus Handicap Inventory ( THI ) rating scale were completed weekly for @ weeks .


None of the patients had significant hearing impairment .


All @ patients ( age range @-@ ; @ men ) tolerated rTMS well and no adverse effects were observed .


Analysis of variance ( ANOVA ) showed significant decrease in THI scores over the entire time period ( F ( @,@ ) = @ , p = @ ) .


At every weekly time point of evaluation , ANOVA with repeated measures demonstrated significantly lower THI score compared to baseline ( p < @ for all ) .


RTMS treatment had resulted in tinnitus reduction in the range of @-@ % over the @ week period .


Separately , ANOVA also demonstrated significantly reducing THI for both the @ pulse ( F ( @,@ ) = @ , p = @ ) and @ pulse ( F ( @,@ ) = @ , p = @ ) rTMS treatment arms .


Comparison of THI ratings between the @ treatment arms did not result in significant difference ( F ( @,@ ) = @ , p = @ ) .


The present study has revalidated the efficacy and safety of rTMS for improving tinnitus up to @ weeks post-treatment in Asians .


However , there was no significant difference with THI evaluation between the @ pulse and @ pulse treatment arms .


To evaluate the impact of remote ischemic preconditioning ( RIPC ) on clinical outcome , biological markers of myocardial injury , and its safety in patients undergoing on-pump coronary artery bypass grafting ( CABG ) .


This study was conducted at Ch .


Pervaiz Elahi Institute of Cardiology ( CPEIC ) in Multan .


The study took place from March @ to June @ .


Patients were randomly placed into two groups .


Group A ( N = @ ) did not undergo RIPC ; Group B ( N = @ ) received RIPC after induction of anesthesia .


Similar standard general anesthesia , cardiopulmonary technique , myocardial protection strategies , and surgical techniques were used in both groups except the protocol for RIPC .


Following postoperative outcome , i.e. cardiac defibrillation after removal of aortic cross clamp during the period of rewarming , demand for intra-aortic balloon pump ( IABP ) , demand for antiarrhythmic before leaving the operation room , postoperative creatine kinase-myocardial band ( CK-MB ) level ( at @h , @h , @h , and @h after surgery ) , postoperative serum creatinine level on first postoperative day , postoperative ejection fraction ( EF ) on third postoperative day , in-hospital mortality , and one-year mortality were noted , prospectively .


Safety of protocol of RIPC was estimated by limb ischemia monitored by pulse oximetry during and after procedure of RIPC and postoperative neurapraxia by nerve examination of right upper limb .


Post aortic cross clamp release cardiac defibrillation , demand for IABP , demand for high inotropes , and use of antiarrhythmic in the operation room were statistically insignificant in the non-RIPC and RIPC group with P values of @ , @ , @ , and @ , respectively .


Mean postoperative CK-MB level ( IU/L ) showed the following results : At @h ( Group A @ + @ , Group B @ + @ , P = @ ) , at @h ( Group A @ + @ , Group B @ + @ , P = @ ) , at @h ( Group A @ + @ , Group B @ + @ , P = @ ) , and at @h ( Group A @ + @ , Group B @ + @ , P = @ ) .


First postoperative day serum creatinine ( Group A @ + @ , Group B @ + @ , P = @ ) and postoperative ejection fraction percentage on the third postoperative day ( Group A @ + @ , Group B @ + @ , P = @ ) showed no statistical difference between two groups .


Postoperative low cardiac output state , in-hospital mortality , and one-year mortality also were statistically insignificant between the groups with P values of @ , @ , and @ , respectively .


None of the patients in either group showed evidence of limb ischemia and neurapraxia of the right upper limb .


RIPC is a safe technique , but it does not have additional clinical benefit after on-pump CABG surgery in the presence of a standard myocardial protective strategy .


Topical tretinoin is commonly prescribed , but its frequent adverse effects are barriers to use .


Predictors of resistance or susceptibility to retinoid irritation are not known .


To identify baseline patient characteristics associated with adverse effects of topical tretinoin .


This cohort study used data collected from @ participants in the Veterans Affairs Topical Tretinoin Chemoprevention trial who were randomized to apply tretinoin cream on the face and ears .


Univariate and multivariate logistic regression models were used to examine the associations between baseline characteristics and local adverse effects .


One hundred and ninety-seven patients ( @ % of those randomized to tretinoin ) reported local adverse effects within @ months .


Clinical signs of severe photodamage at baseline -LSB- odds ratio ( OR ) @ , @ % confidence interval ( CI ) @-@ -RSB- and history of acne ( OR @ , @ % CI @-@ ) were associated with a decreased risk of adverse effects to tretinoin .


The use of other topical medications at enrolment ( OR @ , @ % CI @-@ ) predicted an increase in adverse effects .


In this study population , the common indications of topical tretinoin treatment were associated with lower risks of adverse effects .


The concurrent use of other topical medications may worsen irritation caused by tretinoin .


Between @ and @ U.S. infants are hospitalized for respiratory syncytial virus ( RSV ) bronchiolitis every year .


Up to half will be diagnosed with asthma in later childhood .


Vitamin D deficiency has been associated with susceptibility to asthma and respiratory infections .


Measured vitamin D is largely bound to vitamin D-binding protein ( VDBP ) ; VDBP levels are influenced by its gene ( GC ) haplotype .


We assessed the relationship between polymorphisms rs@ and rs@ , which define haplotypes GC@s , GC@f , and GC@ , and RSV bronchiolitis susceptibility and subsequent asthma .


We retrospectively recruited @ otherwise healthy children ( @ % White ) hospitalized for severe RSV bronchiolitis in Boston and @ parents into a follow-up study to assess asthma diagnosis .


Data were analysed using family-based genetic association tests .


We independently validated our results in @ White children hospitalized with RSV bronchiolitis and @ White population controls from the Netherlands .


The rs@_C allele ( denoting haplotype GC@s ) was overtransmitted ( P = @ , additive model ) in the entire Boston cohort , in Whites ( P = @ ) , and especially in children subsequently diagnosed with asthma ( P = @ ) .


The GC@f haplotype was undertransmitted in the asthma subgroups ( all races and White , both P < @ ) .


The rs@_C allele was also more frequent in the RSV bronchiolitis group compared with controls ( OR @ , @ % CI @ , @ , P = @ ) in the Netherlands , especially in mechanically ventilated patients ( P = @ ) .


GC@s haplotype carriage may increase the risk of RSV bronchiolitis in infancy and subsequent asthma development .


The GC@s haplotype is associated with higher VDBP levels , resulting in less freely available vitamin D.


Vitamin D-binding protein ( VDBP ) haplotypes influence free vitamin D levels .


We report an association between a VDBP haplotype and hospitalization for RSV bronchiolitis in infancy in two independent cohorts .


Psycho-educational interventions for people diagnosed with schizophrenia ( PDwS ) and their primary caregivers appear promising , however , the majority of trials have significant methodological shortcomings .


There is little known about the effects of these interventions delivered in a booklet format in resource-poor countries .


A randomized controlled trial was conducted from September , @ to July , @ with @ dyads of PDwS and their primary caregivers .


Participants aged @ years or older with DSM-IV schizophrenia or schizoaffective disorder , and their primary caregivers , from four outpatient mental health clinics in Jordan , were randomly assigned to receive @ weeks of a booklet form of psycho-education , with follow-up phone calls , and treatment as usual -LSB- TAU -RSB- ( intervention , n = @ ) , or TAU ( control , n = @ ) .


Participants were assessed at baseline , immediately post-intervention ( post-treatment@ ) and at three months follow-up .


The primary outcome measure was change in knowledge of schizophrenia .


Secondary outcomes for PDwS were psychiatric symptoms and relapse rate , with hospitalization or medication ( number of episodes of increasing antipsychotic dosage ) , and for primary caregivers were burden of care and quality of life .


PDwS in the intervention group experienced greater improvement in knowledge scores ( @ vs -@ ; p < @ ) at post-treatment and ( @ vs -@ ; p < @ ) at three month-follow-up , greater reduction in symptom severity ( -@ vs @ ; p < @ : -@ vs -@ ; p < @ , at follow-up times respectively .


Relapse rate with hospitalization was reduced significantly at both follow-up times in the intervention group ( p < @ ) , and relapse with medication increased in the intervention group at both follow-up times ( p < @ ) .


Similarly there was a significant improvement in the primary caregivers knowledge score at post-treatment ( @ vs -@ ; P < @ ) and three month-follow-up ( @ vs -@ ; p < @ ) .


Primary caregivers burden of care was significantly reduced in the intervention group ( -@ vs @ ; p < @ ; -@ vs @ ; p < @ ) , and their quality of life improved ( @ vs -@ ; p = @ ; @ vs -@ ; p < @ ) at post-treatment and three month-follow-up .


Psycho-education and TAU was more effective than TAU alone at improving participants ' knowledge and psychological outcomes .


The purpose of this study was to evaluate the efficacy of osteopathic manipulative treatment ( OMT ) to reduce low back pain and improve functioning during the third trimester in pregnancy and to improve selected outcomes of labor and delivery .


Pregnancy research on osteopathic manipulation optimizing treatment effects was a randomized , placebo-controlled trial of @ women in their third trimester .


Women were assigned randomly to usual care only ( UCO ) , usual care plus OMT ( OMT ) , or usual care plus placebo ultrasound treatment ( PUT ) .


The study included @ treatments over @ weeks .


The OMT protocol included specific techniques that were administered by board-certified OMT specialists .


Outcomes were assessed with the use of self-report measures for pain and back-related functioning and medical records for delivery outcomes .


There were @ women in the OMT group : @ women in the PUT group and @ women in the UCO group .


Characteristics at baseline were similar across groups .


Findings indicate significant treatment effects for pain and back-related functioning ( P < @ for both groups ) , with outcomes for the OMT group similar to that of the PUT group ; however , both groups were significantly improved compared with the UCO group .


For secondary outcome of meconium-stained amniotic fluid , there were no differences among the groups .


OMT was effective for mitigating pain and functional deterioration compared with UCO ; however , OMT did not differ significantly from PUT .


This may be attributed to PUT being a more active treatment than intended .


There was no higher likelihood of conversion to high-risk status based on treatment group .


Therefore , OMT is a safe , effective adjunctive modality to improve pain and functioning during the third trimester .


Atrial fibrillation ( AF ) is the most common sustained cardiac arrhythmia imposing substantial morbidity and mortality .


Catheter-based pulmonary vein isolation ( PVI ) using radiofrequency current ( RFC ) has become a standard treatment for drug-resistant and symptomatic paroxysmal AF ( PAF ) .


In recent years , the cryoballoon-based technique is increasingly used as a promising alternative with a short learning curve .


The FIRE AND ICE trial is a prospective , randomized , controlled , open , blinded outcome assessment , noninferiority trial comparing cryoballoon - , and RFC-based PVI .


Patients with drug-resistant PAF will be randomized in a @:@ matrix in multiple European centers .


The primary hypothesis is that cryoballoon ablation is not inferior to RFC ablation using @-dimensional mapping with respect to clinical efficacy .


The primary endpoint is defined as the time to first documented clinical failure , including : ( @ ) recurrence of AF ; ( @ ) atrial flutter or atrial tachycardia ; ( @ ) prescription of class I or III antiarrhythmic drugs ; or ( @ ) re-ablation , whichever comes first , following a blanking period of @ months after the index ablation procedure .


The primary safety endpoint is a composite of death , stroke/transient ischemic attack , cardiac arrhythmias ( apart from AF recurrence ) causally related to the therapeutic intervention , and procedure-related serious adverse events .


The FIRE AND ICE trial compares @ different technologies to perform catheter ablation of PAF with respect to efficacy and safety .


It aims at providing objective data to guide selection and usage of ablation catheters in the treatment of AF .


As pulmonary arterial hypertension ( PAH ) is associated with significant morbidity and mortality , particularly among patients with right ventricular ( RV ) dysfunction , we aimed to determine the impact of therapy to reduce pulmonary vascular resistance ( PVR ) on RV and LV deformation in PAH .


Right ventricular free wall longitudinal strain ( FWLS ) and LV global circumferential strain ( CS ) were measured at baseline , @ weeks , and @ weeks in @ patients with advanced PAH randomized to imatinib or placebo in the Imatinib in Pulmonary arterial hypertension , a Randomized Efficacy Study ( IMPRES ) trial , and compared with @ healthy controls .


Compared with controls , PAH was associated with impaired RV FWLS ( -@ vs. -@ , respectively ; P < @ ) and LV septal CS ( -@ vs. -@ , respectively , P < @ ) , but not LV global CS .


Improvement in PVR and mean pulmonary artery pressure ( MPAP ) over a @-week period was significantly associated with improvement in RV FWLS ( r = @ , P = @ ; @ , P = @ respectively ) , LV global CS ( r = @ , P = @ ; r = @ , P = @ , respectively ) , and LV septal CS ( r = @ , P = @ ; r = @ , P = @ , respectively ) .


These associations were most robust with LV global and septal CS .


Imatinib therapy was associated with improvement in RV FWLS compared with placebo .


PAH is associated with impaired biventricular deformation .


Reduction in PVR is associated with improvements in both RV and LV deformation , coupled to improvements in MPAP and stroke volume index , with LV global and septal CS the strongest correlates of these changes .


RV FWLS is sensitive to treatment effect , demonstrating greater improvement with imatinib compared with placebo .


The aim of the study was to test the antiviral efficacy of a triple nucleoside reverse transcriptase inhibitor ( NRTI ) regimen , with potential beneficial metabolic effects , as maintenance therapy after induction with dual NRTIs and a boosted protease inhibitor ( PI ) .


An open-label , noninferiority study was carried out .


Antiretroviral therapy ( ART ) - nave patients with CD@ count @ cells/L and HIV-@ RNA > @ copies/mL ( n = @ ) were treated with zidovudine/lamivudine and lopinavir/ritonavir .


After achieving HIV-@ RNA < @ copies/mL on two consecutive occasions between weeks @ and @ after baseline , @ patients ( baseline : median HIV-@ RNA @ log@ copies/mL ; median CD@ count @ cells/L ) were randomized to receive abacavir/lamivudine/zidovudine ( ABC/@TC/ZDV ) ( n = @ ) or to continue the PI-based ART ( n = @ ) .


For the proportions of patients ( intention-to-treat ; missing = failure ) with HIV-@ RNA < @ copies/mL ( PI group , @ % ; ABC/@TC/ZDV group , @ % ) and < @ copies/mL ( PI group , @ % ; ABC/@TC/ZDV group , @ % ) at @ weeks , switching to ABC/@TC/ZDV was noninferior compared with continuing the PI regimen ; the difference in failure rate ( ABC/@TC/ZDV minus PI ) was -@ percentage points -LSB- @ % confidence interval ( CI ) -@ to +@ percentage points -RSB- and +@ percentage points ( @ % CI -@ to +@ percentage points ) , respectively .


In the per protocol analysis , the difference in virological failure for HIV-@ RNA > @ copies/mL ( @ of @ patients in the PI group and two of @ patients in the NRTI group ) and for HIV-@ RNA > @ copies/mL ( two of @ and three of @ patients , respectively ) was +@ percentage points ( @ % CI -@ to +@ percentage points ) and +@ percentage points ( @ % CI -@ to +@ percentage points ) , respectively , also showing noninferiority .


Serum lipids significantly improved in the NRTI group , but not in the PI arm .


A single-class NRTI regimen after successful induction with standard ART had similar antiviral efficacy compared to continuation of a PI-based regimen at @ weeks after baseline , with improved serum lipids .


Multi drug resistant-tuberculosis ( MDR-TB ) -LSB- resistant to Isoniazid and Rifampicin -RSB- is a major global public health problem .


In India the incidence is rising in spite of implementation of Revised National Tuberculosis Control Program .


Standard MDR-TB drugs are second generation antibiotics taken for @-@ months .


The present study was undertaken to evaluate the efficacy of add on homeopathic intervention to the standard MDR-TB regimen ( SR ) .


A randomized , double blind , placebo controlled study was conducted from @ to @ diagnosed MDR-TB patients ( both culture positive and negative ) were enrolled and randomized to receive Standard Regimen + individualized homeopathic medicine ( SR+H ) or Standard Regimen + identical placebo ( SR+P ) .


The medicines have been used in infrequent doses .


The outcome measures were sputum conversion , changes in chest X-ray ( CXR ) , hemoglobin , erythrocyte sedimentation rate ( ESR ) , weight gain , and clinical improvement .


There was an improvement in all the outcome measures as per intention to treat ( ITT ) and per protocol ( PP ) analyses .


ITT analyses revealed sputum culture conversion from positive to negative in @ ( @ % ) in SR+H ; @ ( @ % ) patients in SR+P group ; ( p = @ ) and @ ( @ ) ; @ ( @ % ) , p = @ as PP analyses .


The mean weight gain in SR+H group was @ and in SR+P was @ ; -LSB- p = @ -RSB- , reduction in ESR in SR+H was -@ ; SR+P was @ -LSB- p = @ -RSB- .


The mean increase in hemoglobin was by @ in SR+H & @ -LSB- p = @ -RSB- in SR+P group at @ % confidence interval .


Statistically significant improvement was seen in CXR in @ ( @ % ) in SR+H and @ ( @ % ) patients in SR+P group ( p = @ ) .


Subgroup analyses of culture positive patients showed statistically significant improvement in CXR ( p = @ ) , weight gain ( p = @ ) , increase in hemoglobin ( p = @ ) and reduction in ESR ( p = @ ) with add on homeopathy .


The cure rate was @ % more in SR+H group as compared to placebo group .


Change in sputum culture conversion , was not statistically significant .


Add on homeopathy in addition to standard therapy appears to improve outcome in MDR-TB .


Larger scale studies using a standardized homeopathic treatment regime should be conducted .


In youth , both waterpipe tobacco smoking ( WTS ) and nonmedical use of prescription drugs ( NMUPD ) are globally growing concerns .


This study assesses for the first time the lifetime and past-year associations between WTS and four classes of psychoactive prescription drugs .


Cross-sectional data ( @ ) on @ high school students attending public and private high schools in Beirut ( Lebanon ) was analyzed .


Schools were selected using proportionate random cluster sampling from a comprehensive list of schools provided by the Ministry of Education .


Almost half ( @ % ) had tried WTS compared to @ % who had ever tried cigarettes .


Lifetime prevalence estimates of NMUPD were : pain relievers ( @ % ) , sedatives/tranquilizers ( @ % ) , stimulants ( @ % ) , antidepressants ( @ % ) , and sleeping pills ( @ % ) .


WTS was associated with increased odds of sedatives/tranquilizer use ( OR = @ , @ % CI : @ , @ ) , pain reliever use ( OR = @ , @ % CI : @ , @ ) , and sleeping medication use ( OR = @ , @ % CI : @ , @ ) , controlling for sex , age , school type , and other substance use .


For cigarettes , the associations were consistently either weaker or non-existent , except with stimulant use ( OR = @ , @ % CI : @ , @ ) .


While public health professionals have watched with caution the global prevalence of youth cigarette use-worldwide , an insidious alternative form of tobacco use has grown .


Further research is needed to understand the unique risk factors and motives associated with WTS and how these relate to NMUPD in order to inform the development of effective intervention programs and policies that support youth positive health decisions .


Vaccine effectiveness of pneumococcal conjugate vaccines against culture-confirmed invasive pneumococcal disease has been well documented .


In the Finnish Invasive Pneumococcal disease ( FinIP ) trial , we reported vaccine effectiveness and absolute rate reduction against laboratory-confirmed invasive pneumococcal disease ( confirmation by culture or antigen or DNA detection irrespective of serotype ) .


Here , we assessed vaccine effectiveness of PHiD-CV@ against clinically suspected invasive pneumococcal disease in children by use of diagnoses coded in hospital discharge registers .


For this phase @/@ cluster-randomised , double-blind trial , undertaken between Feb @ , @ , and Dec @ , @ , in municipal health-care centres and the Tampere University Vaccine Research Centre ( Finland ) , we randomly assigned ( @:@:@:@ ) @ clusters into PHiD-CV@ three plus one , PHiD-CV@ two plus one , control three plus one , control two plus one groups ( @:@:@:@ clusters ) to give PHiD-CV@ in either three plus one or two plus one schedule ( if enrolled before @ months of age ; infant schedules ) , two plus one ( if enrolled between @ and @ months ; catch-up schedules ) , and two doses at least @ months apart ( if enrolled between @ and @ months ; catch-up schedules ) .


Children were eligible if they had not received and were not anticipated to receive any of the study vaccines and had no general contraindications to vaccinations .


We collected all inpatient and outpatient discharge notifications from the national hospital discharge register with International Classification of Diseases ( ICD ) @ diagnoses compatible with invasive pneumococcal disease or unspecified sepsis , and verified data with patient files .


We excluded invasive pneumococcal disease cases confirmed by positive culture or DNA/RNA detection from normally sterile body fluid .


The primary objective was to estimate vaccine effectiveness against all register-based non-laboratory-confirmed invasive pneumococcal disease or unspecified sepsis and patient-file verified non-laboratory-confirmed invasive pneumococcal disease in infants younger than @ months at enrolment .


Masked follow-up lasted from the date of the first vaccination to Dec @ , @ .


Vaccine effectiveness was calculated against all episodes .


This trial is registered with ClinicalTrials.gov , numbers NCT@ and NCT@ .


We enrolled @,@ children .


On the basis of ICD-@ diagnoses , we recorded @ episodes of register-based non-laboratory-confirmed invasive pneumococcal disease or unspecified sepsis , of which @ were patient-file verified non-laboratory-confirmed invasive pneumococcal disease .


The vaccine effectiveness was @ % ( @ % CI @-@ ) in the @,@ infants with three plus one and two plus one schedules combined and the absolute incidence rate reduction was @ episodes per @,@ person-years ( @ % CI @-@ ) .


The vaccine effectiveness against the patient-file verified non-laboratory-confirmed invasive pneumococcal disease was @ % ( @ % CI @-@ ) in infant three plus one and two plus one schedules combined .


The absolute rate reduction was @ episodes per @,@ person-years ( @ % CI @-@ ) in infant cohorts .


This vaccine-probe analysis is the first report showing the effect of pneumococcal conjugate vaccines on clinically suspected invasive pneumococcal disease .


The absolute rate reduction was markedly higher compared with laboratory-confirmed invasive pneumococcal disease , which implies low sensitivity of the laboratory-based case definitions and subsequently higher public health effect of pneumococcal conjugate vaccines against invasive pneumococcal disease than previously estimated .


Communication problems impede effective symptom management during chemotherapy .


The primary aim of this pilot randomized controlled trial was to test the effects of a personal digital assistant-delivered communication intervention on pain , depression , and fatigue symptoms among breast cancer patients undergoing chemotherapy .


Secondary aims included assessment of @ ) study feasibility , @ ) patient and clinician responses to study participation , and @ ) intervention effects on health-related quality of life ( HRQoL ) and communication self-efficacy .


Intervention group participants ( n = @ ) completed symptom inventories at baseline , once per week during treatment , and at posttreatment .


Depending on symptom severity , they viewed race-concordant videos on how to communicate about pain , depression and/or fatigue , using the personal digital assistant .


Symptom records were tracked and shared with clinicians .


Control group participants ( n = @ ) received usual care .


Longitudinal random effects modeling assessed the changes in average symptom scores over time .


Descriptive statistics assessed study feasibility and intervention effects on HRQoL and communication self-efficacy .


Postintervention focus groups , interviews , and surveys assessed responses to study participation .


Mean age of the participants was @ years ; @ participants ( @ % ) were white .