The pull out strength of anterior transpedicular screws system is better than vertebral body screws system , and the anterior transpedicular screws has the biomechanical feasibility in clinic .


Activation of the melanocortin-4 receptor ( MC4R ) with the synthetic agonist RM-493 decreases body weight and increases energy expenditure ( EE ) in nonhuman primates .


The effects of MC4R agonists on EE in humans have not been examined to date .


In a randomized , double-blind , placebo-controlled , crossover study , we examined the effects of the MC4R agonist RM-493 on resting energy expenditure ( REE ) in obese subjects in an inpatient setting .


Twelve healthy adults ( 6 men and 6 women ) with body mass index of 35.7 2.9 kg/m ( 2 ) ( mean SD ) received RM-493 ( 1 mg/24 h ) or placebo by continuous subcutaneous infusion over 72 hours , followed immediately by crossover to the alternate treatment .


All subjects received a weight-maintenance diet ( 50 % carbohydrate , 30 % fat , and 20 % protein ) and performed 30 minutes of standardized exercise daily .


Continuous EE was measured on the third treatment day in a room calorimeter , and REE in the fasting state was defined as the mean of 2 30-minute resting periods .


RM-493 increased REE vs placebo by 6.4 % ( 95 % confidence interval , 0.68-13 .02 % ) , on average by 111 kcal/24 h ( 95 % confidence interval , 15-207 kcal , P = .03 ) .


Total daily EE trended higher , whereas the thermic effect of a test meal and exercise EE did not differ significantly .


The 23-hour nonexercise respiratory quotient was lower during RM-493 treatment ( 0.833 0.021 vs 0.848 0.022 , P = .02 ) .


No adverse effect on heart rate or blood pressure was observed .


Short-term administration of the MC4R agonist RM-493 increases REE and shifts substrate oxidation to fat in obese individuals .


Conventional total knee arthroplasty is performed with use of an intramedullary alignment guide , which produces elevated intramedullary pressure that can create fat emboli .


Total knee arthroplasty performed via computer-assisted surgery does not require an intramedullary femoral rod , raising the question of whether computer-assisted surgery generates less embolic material than conventional total knee arthroplasty .


The purpose of this study was to compare the emboli produced in the two techniques .


Fifty-seven patients were randomized into two groups : the computer-assisted surgery group ( n = 29 ) and the conventional total knee arthroplasty group ( n = 28 ) .


An intramedullary femoral alignment jig was used in the conventional total knee arthroplasty group but not in the computer-assisted surgery group .


Intraoperative invasive monitoring was performed with use of transesophageal echocardiography and a pulmonary artery catheter .


The mean embolic score was 6.21 points for the conventional technique group and 5.48 points for the computer-assisted surgery group ( p = 0.0161 ) .


After tourniquet deflation , fat emboli were observed in the blood of five patients in the conventional surgery group and one patient in the computer-assisted surgery group .


The patients in the computer-assisted surgery group had lower embolic loads compared with the patients in the conventional total knee arthroplasty group .


In patients with an uncompromised cardiopulmonary system , the embolic load difference between the techniques was not clinically relevant .


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .


Cardiovascular disease , endothelial dysfunction , and oxidative stress are common complications among patients with type 2 diabetes ( T2DM ) .


In addition to the average blood glucose concentration , glycemic variability may be an important factor for the development of chronic diabetes complications .


Patients with T2DM are treated with various types of oral glucose-lowering drugs .


Exercise is considered to benefit the health of both healthy and unhealthy individuals , which has been confirmed by a number of scientific research studies in which the participants ' health improved .


Our general aim in this study will be to evaluate glucose variability after submaximal exercise test in patients receiving treatment with either vildagliptin or glibenclamide .


The specific aims of this study are to evaluate the oxidative stress , endothelial function , and metabolic and cardiovascular responses to exercise under treatment with vildagliptin or glibenclamide .


All these responses are important in patients with T2DM .


This study is a PROBE ( Prospective , Randomized , Open-label , Blinded-Endpoint ) design clinical trial .


The estimated sample needed is 20 patients with T2DM .


In addition to the routine treatment ( metformin ) , patients will receive a second drug orally for 12 weeks : the METV group will receive metformin plus vildagliptin ( 50 mg twice daily ) , and the METG group will receive metformin plus glibenclamide ( 5 to 10 mg twice daily . )


Before and after intervention , evaluation of glycemic variability , endothelial function , oxidative stress , and metabolic and cardiovascular response will be performed at rest , during and after a submaximal exercise test ( 30 minutes , with an intensity based at 10 % under the heart rate at the second threshold ) .


In addition to drug treatment , exercise is recommended for treatment of glycemic control in patients with T2DM , especially for its beneficial effects on blood glucose and HbA1c .


Few studies have determined the effects of the association between exercise and oral glucose-lowering drugs .


The study will be conducted to assess the metabolic and cardiovascular responses at rest , and during and after submaximal exercise in patients receiving one of two oral glucose-lowering drugs ( vildagliptin or glibenclamide ) .


ClinicalTrials.gov Identifier : NCT01867502 study release date : May-17-2013 .


Injury knowledge and beliefs influence uptake of prevention programmes , but the relationship between knowledge , beliefs and adherence remains unclear .


To describe injury knowledge and beliefs among youth female soccer coaches and players , and to identify the relationship between these factors , different delivery strategies of the FIFA 11 + programme and adherence .


A subcohort analysis from a cluster-randomised controlled trial of 31 female soccer teams ( coaches n = 29 , players ( ages 13-18 ) n = 258 ) .


Preseason and postseason questionnaires were used to assess knowledge and beliefs .


Teams recorded FIFA 11 + adherence during the season .


At baseline , 62.8 % ( 95 % CI 48.4 % to 77.3 % ) of coaches and 75.8 % ( 95 % CI 71.5 % to 80.1 % ) of players considered ` inadequate warm-up ' a risk factor for injury .


There was no effect of delivery method ( OR = 1.1 ; 95 % CI 0.8 to 1.5 ) or adherence ( OR = 1.0 ; 95 % CI 0.9 to 1.1 ) on this belief .


At baseline , 13.8 % ( 95 % CI 1.3 % to 26.4 % ) of coaches believed a warm-up could prevent muscle injuries , but none believed it could prevent knee and ankle injuries .


For players , 9.7 % ( 95 % CI 6.1 % to 13.3 % ) , 4.7 % ( 95 % CI 2.1 % to 7.3 % ) and 4.7 % ( 95 % CI 2.1 % to 7.3 % ) believed a warm-up would prevent muscle , knee and ankle injuries , respectively .


Years of playing experience were negatively associated with high adherence for coaches ( OR = 0.93 ; 0.88 to 0.99 ) and players ( OR = 0.92 ; 0.85 to 0.98 ) .


There were gaps in injury knowledge and beliefs , which differed for coaches and players .


Beliefs did not significantly affect adherence to the FIFA 11 + , suggesting additional motivational factors should be considered .


Social network analysis was used to examine whether peer influence from one 's social networks moderates obesity prevention program effects on obesity-related behaviors : healthful and unhealthful .


Participants included 557 children residing in Southern California .


The survey assessed health-promoting behaviors ( i.e. , physical activity at school , physical activity outside of school , and fruit and vegetable intake ) , as well as unhealthful behaviors ( high-calorie , low-nutrient intake and sedentary activity ) , and peer exposure calculated from social network nominations as indicators of peer influence .


Multilevel models were conducted separately on outcomes predicted by program participation , peer exposure , and program participation by peer exposure .


Results indicated that peer exposure was positively associated with one 's own healthful and unhealthful behaviors .


Program participation effects were moderated by peer influence , but only when unhealthful peer influence was present .


Results suggest that peer influence can diminish or amplify prevention programs


Future interventions should consider peer-led components to promote healthful influence of peers on healthful and unhealthful behaviors , and programs should be mindful that their effects are moderated by social networks .


Chronic obstructive pulmonary disease ( COPD ) remains a major health problem , strongly related to smoking .


Despite the publication of practice guidelines on prevention and treatment , not all patients with the disease receive the recommended healthcare , particularly with regard to smoking cessation advice where applicable .


We have developed a tailored implementation strategy for enhancing general practitioners ' adherence to the disease management guidelines .


The primary aim of the study is to evaluate the effects of this tailored implementation intervention on general practitioners ' adherence to guidelines .


A pragmatic two-arm cluster randomized trial has been planned to compare care following the implementation of tailored interventions of four recommendations in COPD patients against usual care .


The study will involve 18 general practices ( 9 in the intervention group and 9 in the control group ) in Poland , each with at least 80 identified ( at the baseline ) patients with diagnosed COPD .


The nine control practices will provide usual care without any interventions .


Tailored interventions to implement four recommendations will be delivered in the remaining nine practices .


At follow-up after nine months , data will be collected for all 18 general practices .


The primary outcome measure is physicians ' adherence to all four recommendations : brief anti-smoking advice , dyspnea assessment , care checklist utilization and demonstration to patients of correct inhaler use .


This measurement will be based on data extracted from identified patients ' records .


Additionally , we will survey and interview patients with chronic obstructive pulmonary disease about the process of care .


The results of this trial will be directly applicable to primary care in Poland and add to the growing body of evidence on interventions to improve chronic illness care .


This trial has been registered with Clinical Trials Protocol Registration System .


NCT01893476 .


Despite widespread use internationally , there is no convincing evidence that community treatment orders ( CTO ) ( legal regimes making out-patient treatment compulsory ) , reduce readmission rates or have wider patient benefit .


The primary and secondary outcomes of the Oxford Community Treatment Order Evaluation Trial ( OCTET ) ( hospitalisation ) showed no benefit .


This article will , first , test the effect of community compulsion on wider clinical and social outcomes and on patients ' experiences of services and the use of treatment pressure and second , explore differential effects in different groups of patients .


OCTET is a RCT of CTO effectiveness .


Three hundred and thirty-six patients were randomised and data for the 333 eligible patients were collected from interviews and medical records at baseline , 6 and 12months .


There was no significant difference at 12 months between the two arms in any of the reported outcomes , except a small difference in patients ' view of the effectiveness of treatment pressure , which is unlikely to be clinically meaningful .


Two statistically significant interactions were found in the subgroup analysis : symptoms interacted with age and with education , but no pattern was demonstrated .


CTOs do not have benefit on any of the tested outcomes , or for any subgroup of patients .


Their continued use should be carefully reconsidered .


Tobacco use is common among emergency department ( ED ) patients , many of whom have low income .


Our objective is to study the efficacy of an intervention incorporating motivational interviewing , nicotine replacement , and quitline referral for adult smokers in an ED .


This was a 2-arm randomized clinical trial conducted from October 2010 to December 2012 in a northeastern urban US ED with 90,000 visits per year .


Eligible subjects were aged 18 years or older , smoked , and were self-pay or had Medicaid insurance .


Intervention subjects received a motivational interview by a trained research assistant , 6 weeks ' worth of nicotine patches and gum initiated in the ED , a faxed referral to the state smokers ' quitline , a booster call , and a brochure .


Control subjects received the brochure , which provided quitline information .


The primary outcome was biochemically confirmed tobacco abstinence at 3 months .


Secondary endpoints included quitline use .


Of 778 enrolled subjects , 774 ( 99.5 % ) were alive at 3 months .


The prevalence of biochemically confirmed abstinence was 12.2 % ( 47/386 ) in the intervention arm versus 4.9 % ( 19/388 ) in the control arm , for a difference in quit rates of 7.3 % ( 95 % confidence interval 3.2 % to 11.5 % ) .


In multivariable logistic modeling controlling for age , sex , and race or ethnicity , study subjects remained more likely to be abstinent than controls ( odds ratio 2.72 ; 95 % confidence interval 1.55 to 4.75 ) .


An intensive intervention improved tobacco abstinence rates in low-income ED smokers .


Because approximately 20 million smokers , many of whom have low income , visit US EDs annually , these results suggest that ED-initiated treatment may be an effective technique to treat this group of smokers .


We evaluated the cross-time association between midlife dietary vitamin D intake and subsequent cognitive performance in a French general-population sample .


Data from participants in both the SU.VI.MAX trial ( 1994-2002 ) and the SU.VI.MAX 2 observational study ( 2007-2009 ) were used .


Dietary intake was estimated at baseline from 6 or more 24-hour records .


Cognitive performance was evaluated 13 years later with a comprehensive neuropsychological battery .


Parameter estimates of cognitive performance according to quartiles ( Q ) of vitamin D intake were estimated via ANCOVA .


In a sample of 1,990 aging adults , principal component analyses yielded two cognitive factors - for episodic/semantic memory and short-term memory/executive function ; however , neither one displayed associations with dietary vitamin D intake .


Midlife vitamin D intake was significantly and positively associated with scores on the forward digit span task measuring short-term memory ( fully adjusted model : mean difference , Q4 vs. Q1 = 1.95 ; 95 % CI 0.37-3 .53 ; p ( trend ) = 0.03 ) .


No significant interaction with either sex or lifetime sun exposure was found .


Midlife vitamin D intake exhibited a cross-time and domain-specific association with cognition in the context of aging .


Further investigations in this area of prevention are warranted given the rapidly expanding elderly population and the absence of curative treatment for dementia .


Death from infection is a highly heritable trait , yet there are few genetic variants with known mechanism influencing survival during septic shock .


We hypothesized that a synonymous coding variant in the IL-1 receptor antagonist gene ( IL1RN ) , rs315952 , previously associated with reduced risk for acute respiratory distress syndrome , would be functional and associate with improved survival in septic shock .


We used a human endotoxin ( LPS ) model of evoked inflammatory stress to measure plasma IL-1 receptor antagonist ( IL1RA ) following low-dose Food and Drug Administration-grade LPS injection ( 1 ng/kg ) in 294 human volunteers .


RNA sequencing of adipose tissue pre - and post-LPS was used to test for allelic imbalance at rs315952 .


In the Vasopressin and Septic Shock Trial cohort , we performed a genetic association study for survival , mortality , and organ failure-free days .


Adipose tissue displayed significant allelic imbalance favoring the rs315952C allele in subjects of European ancestry .


Consistent with this , carriers of rs315952C had slightly higher plasma IL1RA at baseline ( 0.039 ) and higher evoked IL1RA post-LPS ( 0.011 ) .


In the Vasopressin and Septic Shock Trial cohort , rs315952C associated with improved survival ( P = 0.028 ) , decreased adjusted 90-day mortality ( P = 0.044 ) , and faster resolution of shock ( P = 0.029 ) .


In European ancestry subjects , the IL1RN variant rs315952C is preferentially transcribed and associated with increased evoked plasma IL1RA and with improved survival from septic shock .


It may be that genetically determined IL1RA levels influence survival from septic shock .


The aim of this investigation was to assess the comparative gingivitis and plaque reduction efficacy of a leading oscillating-rotating power toothbrush and a recently introduced sonic toothbrush in adults with gingivitis .


This was a 12-week , randomized and controlled , parallel group , examiner-blind , single-center clinical study of 130 adults with pre-existing gingivitis and plaque .


At baseline , the Modified Gingival Index ( MGI ) , Gingival Bleeding Index ( GBI ) , and total number of bleeding sites were assessed , along with plaque levels ( whole mouth , gingival margin , and interproximal ) via the Rustogi Modified Navy Plaque Index ( RMNPI ) .


Qualified subjects were randomly assigned to one of two power toothbrush test groups : the Oral-B Triumph with SmartGuide ( marketed in the United States as the Oral-B Professional Care SmartSeries 5000 [ D34 ] ) oscillating-rotating brush , or the Colgate ProClinical A1500 ( also marketed as elmex ProClinical ) sonic brush .


Subjects brushed at home for two minutes twice daily with their assigned power toothbrush and a marketed sodium fluoride dentifrice , and were reevaluated for gingivitis at Week 4 and Week 12 via the MGI , GBI , and total number of bleeding sites , and for plaque reduction via the RMNPI .


Ninety-seven percent ( 97 % ) of the 130 enrolled subjects completed the trial and 62 and 65 subjects in the oscillating-rotating and sonic brush groups , respectively , had evaluable data for analysis .


Statistically significant mean reductions in all three gingivitis parameters and plaque relative to baseline were seen at both Weeks 4 and 12 with unsupervised use of both test toothbrushes ( p < 0.001 ) .


The oscillating-rotating power brush provided statistically significantly superior reductions compared to the sonic brush in mean adjusted MGI ( 31 % and 29 % at Weeks 4 and 12 , respectively ; p < 0.001 ) , GBI ( 17 % at Week 12 ; p = 0.047 ) , and total number of bleeding sites ( 48 % and 30 % at Weeks 4 and 12 , respectively ; p = 0.002 ) , and produced statistically significantly greater relative mean adjusted plaque reductions for RMNPI whole mouth plaque ( 38 % and 24 % at Weeks 4 and 12 , respectively ; p < 0.001 ) , gingival margin plaque ( 36 % at Week 4 ; p = 0.004 ) , and interproximal plaque ( 39 % and 26 % at Weeks 4 and 12 , respectively ; p < 0.001 ) .


Both power toothbrushes were well-tolerated .


An advanced oscillating-rotating power toothbrush produced substantial , statistically superior reductions in plaque and gingivitis via multiple outcome measures compared to a new sonic toothbrush after both four weeks and 12 weeks of tooth brushing .


The objective of our study was to determine the feasibility of using Metal Artifact Reduction ( MAR ) software for abdominopelvic dual-energy CT in patients with metal hip prostheses .


This retrospective study included 33 patients ( male-female ratio , 19:14 ; mean age , 63.7 years ) who received total hip replacements and 20 patients who did not have metal prostheses as the control group .


All of the patients underwent dual-energy CT. .


The quality of the images reconstructed using the MAR algorithm and of those reconstructed using the standard reconstruction was evaluated in terms of the visibility of the bladder wall , pelvic sidewall , rectal shelf , and bone-prosthesis interface and the overall diagnostic image quality with a 4-point scale .


The mean and SD attenuation values in Hounsfield units were measured in the bladder , pelvic sidewall , and rectal shelf .


For validation of the MAR interpolation algorithm , pelvis phantoms with small bladder `` lesions '' and metal hip prostheses were made , and images of the phantoms both with and without MAR reconstruction were evaluated .


Image quality was significantly better with MAR reconstruction than without at all sites except the rectal shelf , where the image quality either had not changed or had worsened after MAR reconstruction .


The mean attenuation value was changed after MAR reconstruction to its original expected value at the pelvic sidewall ( p < 0.001 ) and inside the bladder ( p < 0.001 ) .


The SD attenuation value was significantly decreased after MAR reconstruction at the pelvic sidewall ( p = 0.019 ) but did not show significant differences at the bladder ( p = 0.173 ) or rectal shelf ( p = 0.478 ) .


In the phantom study , all lesions obscured by metal artifacts on the standard reconstruction images were visualized after MAR reconstruction ; however , new artifacts had developed in other parts of the MAR reconstruction images .


The use of MAR software with dual-energy CT decreases metal artifacts and increases diagnostic confidence in the assessment of the pelvic cavity but also introduces new artifacts that can obscure pelvic structures .


To obtain safety and efficacy data on combination treatment with iguratimod and methotrexate ( MTX ) in an open-label extension study in patients with active rheumatoid arthritis ( RA ) .


Following a 28-week , randomized , double-blind trial of adding iguratimod or placebo to stable MTX therapy , patients entered a 24-week extension .


Patients randomized to the iguratimod + MTX group continued treatment .


Patients treated with placebo + MTX switched to iguratimod + MTX [ the ( placebo/iguratimod ) + MTX group ] .


In the iguratimod + MTX group , the rate of 20 % improvement in American College of Rheumatology criteria ( ACR20 ) at week 52 ( 71.3 % ) was similar to that at week 24 ( 69.5 % ) .


ACR50 , ACR70 and Health Assessment Questionnaire Disability Index at week 52 significantly improved compared with the values at week 24 .


In the ( placebo/iguratimod + MTX ) group , the switch to iguratimod treatment significantly improved ACR20 from 30.7 % at week 24 to 72.1 % at week 52 .


Frequent adverse events for 52 weeks in the iguratimod + MTX group were nasopharyngitis , upper respiratory tract inflammation , stomatitis , lymphocyte decrease , AST increase , ALT increase and blood iron decrease .


These adverse events were predominantly mild or moderate in severity .


No deaths occurred .


Efficacy and tolerance of iguratimod + MTX therapy was maintained to 52 weeks in patients with active RA with inadequate response to MTX .


Bystander intervention approaches offer promise for reducing rates of sexual violence on college campuses .


Most interventions are in-person small-group formats , which limit their reach and reduce their overall public health impact .


This study evaluated the efficacy of RealConsent , a Web-based bystander approach to sexual violence prevention , in enhancing prosocial intervening behaviors and preventing sexual violence perpetration .


A random probability sample of 743 male undergraduate students ( aged 18 to 24 years ) attending a large , urban university located in the southeastern United States was recruited online and randomized to either RealConsent ( n = 376 ) or a Web-based general health promotion program ( n = 367 ) .


Participants were surveyed online at baseline , postintervention , and 6-months postintervention .


RealConsent was delivered via a password-protected Web portal that contained six 30-minute media-based and interactive modules covering knowledge of informed consent , communication skills regarding sex , the role of alcohol and male socialization in sexual violence , empathy for rape victims , and bystander education .


Primary outcomes were self-reported prosocial intervening behaviors and sexual violence perpetration .


Secondary outcomes were theoretical mediators ( eg , knowledge , attitudes ) .


At 6-month follow-up RealConsent participants intervened more often ( P = .04 ) and engaged in less sexual violence perpetration ( P = .04 ) compared to controls .


In addition , RealConsent participants reported greater legal knowledge of sexual assault ( P < .001 ) , greater knowledge of effective consent ( P < .001 ) , less rape myths ( P < .001 ) , greater empathy for rape victims ( P < .001 ) , less negative date rape attitudes ( P < .001 ) , less hostility toward women ( P = .01 ) , greater intentions to intervene ( P = .04 ) , less hyper-gender ideology ( P < .001 ) , less positive outcome expectancies for nonconsensual sex ( P = .03 ) , more positive outcome expectancies for intervening ( P < .001 ) , and less comfort with other men 's inappropriate behaviors ( P < .001 ) .


Our results support the efficacy of RealConsent .


Due to its Web-based format , RealConsent has potential for broad-based dissemination thereby increasing its overall public health impact on sexual violence .


Clinicaltrials.gov : NCT01903876 ; http://clinicaltrials.gov/show/NCT01903876 ( Archived by WebCite at http://www.webcitation.org/6S1PXxWKt ) .


HIV spread rapidly among people who inject drugs in Bangkok in the late 1980s .


In recent years , changes in drug use and HIV-associated risk behaviors have been reported .


We examined data from the Bangkok Tenofovir Study , an HIV pre-exposure prophylaxis trial conducted among people who inject drugs , to assess participant risk behavior and drug use , and to identify risk factors for HIV infection .


The Bangkok Tenofovir Study was a randomized , double-blind , placebo-controlled trial .


HIV status was assessed monthly and risk behavior every 3 months .


We used generalized estimating equations logistic regression to model trends of injecting , needle sharing , drugs injected , incarceration , and sexual activity reported at follow-up visits ; and proportional hazards models to evaluate demographic characteristics , sexual activities , incarceration , drug injection practices , and drugs injected during follow-up as predictors of HIV infection .


The proportion of participants injecting drugs , sharing needles , and reporting sex with more than one partner declined during follow-up ( p < 0.001 ) .


Among participants who reported injecting at enrollment , 801 ( 53.2 % ) injected methamphetamine , 559 ( 37.1 % ) midazolam , and 527 ( 35.0 % ) heroin .


In multivariable analysis , young age ( i.e. , 20-29 years ) ( p = 0.02 ) , sharing needles ( p < 0.001 ) , and incarceration in prison ( p = 0.002 ) were associated with incident HIV infection .


Participants reporting sex with an opposite sex partner , live-in partner , casual partner , or men reporting sex with male partners were not at a significantly higher risk of HIV infection compared to those who did not report these behaviors .


Reports of HIV-associated risk behavior declined significantly during the trial .


Young age , needle sharing , and incarceration were independently associated with HIV infection .


Sexual activity was not associated with HIV infection , suggesting that the reduction in HIV incidence among participants taking daily oral tenofovir compared to those taking placebo was due to a decrease in parenteral HIV transmission .


In our published randomized , double-blind , placebo-controlled , 3-period crossover trial , healthy adult men ( n = 21 ) consumed bars containing no supplemental fiber ( placebo ; NFC ) , polydextrose ( 21 g/d ) , and soluble corn fiber ( SCF ; 21 g/d ) for 21 d each .


Fecal specimens were collected between days 16 and 21 for fermentative end-product analysis and 16S ribosomal RNA bacterial gene amplification for bacterial taxa identification .


Fiber supplementation decreased fecal putrefaction compounds and shifted abundances of several bacterial taxa .


The objective was to perform whole-genome shotgun 454 pyrosequencing on the same fecal specimens collected in that clinical trial to obtain comprehensive fecal bacterial genome sequencing coverage and explore the full range of bacterial genetic information in the fecal microbiome , thereby using a systematic approach to study the impact of dietary fiber supplementation on fecal metabolites , bacterial taxa , and bacterial metagenomes .


Fecal samples were subjected to whole-genome shotgun 454 pyrosequencing to identify both fecal bacterial populations present and their functional genetic capacity .


Whole-genome shotgun sequencing results revealed that fiber consumption shifted the Bacteroidetes : Firmicutes ratio , increasing the relative abundance of Bacteroidetes 12 2 % and 13 2 % with polydextrose and SCF , respectively , compared with NFC .


Bivariate correlations showed a positive correlation between the Bacteroidetes : Firmicutes ratio and total dietary fiber intake but not body mass index .


Principal coordinates analysis of Bray-Curtis distances indicated that bacterial gene composition was more similar in participants consuming fibers ( polydextrose and SCF combined ) in comparison with NFC .


Shifts in bacterial gene abundances after polydextrose and SCF supplementation included genes associated with carbohydrate , amino acid , and lipid metabolism , as well as metabolism of cofactors and vitamins .


This study conveys novel information about the impact of dietary fiber supplementation on the phylogenetic structure and functional capacity of the fecal microbiome of healthy adults .


Intermediate care is intended to reduce hospital admissions and facilitate early discharge .


In Norway , a model was developed with transfer to intermediate care shortly after hospital admission .


Efficacy and safety of this model have not been studied previously.In a parallel-group randomized controlled trial , patients over 70 years living at home before admission were eligible if clinically stable , without need for surgical treatment and deemed suited for intermediate care by attending physician .


Intervention group patients were transferred to a nursing home unit with increased staff and multidisciplinary assessment , for a maximum stay of three weeks .


Patients in the control group received usual care in hospital .


Blinding to group assignment was not possible.The primary outcome was number of days living at home in a follow-up period of 365 days .


Secondary outcomes were mortality , hospital admissions , need for residential care and home care services .


Data were obtained from patient records and registers .


376 patients were included , 74 % female and mean age 84 years .


There was no significant differences between intervention ( n = 190 ) and control group ( n = 186 ) for number of days living at home ( 253.7 vs 256.5 , p = 0.80 ) or days in hospital ( 10.4 vs 10.5 , p = 0.748 ) .


Intervention group patients spent less time in nursing home ( 40.6 days vs. 55.0 , p = 0.046 ) , and more patients lived independently without home health care services ( 31.6 % vs 19.9 % , p = 0.007 ) .


For orthopaedic patients ( n = 128 ) , mortality was higher in the intervention group ; 15 intervention patients and 7 controls died ( 25.1 % vs 10.3 % , p = 0.049 ) .


There was no significant difference in one-year mortality for medical patients ( n = 150 ) or the total study population .


This model of rapid transfer to intermediate care did not significantly influence number of days living at home during one year follow-up , but reduced demand for nursing home care and need for home health care services .


In post-hoc analysis mortality was increased for orthopedic patients .


The trial was registered 26 .


July 2013 at Current Controlled Trials and assigned with registration number ISRCTN21608185 .


Individuals with eating disorders show deficits in neuropsychological functioning which might preexist and underlie the etiology of the eating disorders and influence relapse .


Deficits in cognitive flexibility , i.e. , set-shifting and central coherence , might perpetuate the symptoms .


Cognitive remediation therapy ( CRT ) was developed to improve cognitive flexibility , thereby increasing the likelihood of improved outcome .


The focus of CRT is on how patients think , rather than on what patients think .


The present study investigated the effectiveness of CRT for patients with a severe or enduring eating disorder by means of a randomized controlled trial comparing intensive treatment as usual ( TAU ) to CRT plus TAU .


Eighty-two patients were randomly assigned to CRT plus TAU ( n = 41 ) or TAU alone ( n = 41 ) .


Outcome measures were set-shifting , central coherence , eating disorder and general psychopathology , motivation , quality of life and self-esteem .


Assessments were performed at baseline ( n = 82 ) and after 6 weeks ( T1 ; n = 75 ) and 6 months ( T2 ; n = 67 ) .


Data were analyzed by means of linear mixed model analyses .


Patients who received CRT in addition to TAU improved significantly more with regard to eating disorder-related quality of life at the end of treatment ( T1 ) and eating disorder psychopathology at follow-up ( T2 ) , compared to those who received TAU only .


Moreover , moderator analyses revealed that patients with poor baseline set-shifting abilities benefited more from CRT than patients with no deficits in set-shifting abilities at baseline ; the quality of life of the former group was higher than that of the latter at follow-up .


CRT seems to be promising in enhancing the effectiveness of concurrent treatment .


Depression is one of the most common psychiatric illnesses worldwide , but is nevertheless preventable .


Since the children of parents who have depression are at greatest risk of developing depression themselves , prevention programmes for this population are a major public health priority .


Here we report the study protocol of a randomised controlled trial of a group-based psychological intervention for families with i ) at least one parent who suffers ( or has suffered ) from depression and ii ) at least one child who has no current or previous psychiatric diagnosis .


Eligible families will be randomly allocated to receive either a German adaptation of the 12-session cognitive-behavioural Raising Healthy Children intervention ( Gesund und glcklich aufwachsen ; N = 50 ) , or no intervention ( usual care ; N = 50 ) .


The primary outcome ( child diagnosis of an episode of depression ) will be assessed at 15-month follow-up .


The secondary outcomes ( child psychopathological symptoms ) will be assessed immediately following completion of the intervention ( 6-months ) , as well as at 9 - and 15-month follow-up .


We hypothesise that children in the intervention condition , compared with those who do not receive the intervention , will show fewer symptoms of psychopathology , and be less likely to meet diagnostic criteria for a depressive episode , at follow-up .


Despite their elevated risk of developing depression , there is little formal support available for the children of parents with depression .


This study provides an important step in the development of more effective depression prevention measures , which are needed if the personal , social and economic burden of depression is to be reduced .


Clinical Trials NCT02115880 .


Registered April 7 2014 .


The choice of anaesthetic technique for patients undergoing joint arthroplasty is debatable .


The hypothesis of this study was that general anaesthesia would generate a more favourable recovery profile than spinal anaesthesia .


We randomly allocated 120 patients to either intrathecal bupivacaine or general anaesthesia with target-controlled infusion of remifentanil and propofol .


Length of hospital stay assessed as meeting discharge criteria was the primary outcome parameter .


Other outcome parameters were actual time of discharge , pain , use of rescue pain medication , blood loss , length of stay in the post-operative care unit , dizziness , post-operative nausea , need of urinary catheterisation and patient satisfaction .


General anaesthesia resulted in slightly reduced length of hospital stay ( 26 vs. 30h , P = 0.004 ) , less nausea ( P = 0.043 ) and dizziness ( P < 0.001 ) .


General anaesthesia patients had higher pain scores during the first two post-operative hours ( P < 0.001 ) but lower after 6h compared with the spinal anaesthesia group ( P < 0.01 and P < 0.05 ) .


General anaesthesia patients had better orthostatic function compared with spinal anaesthesia patients ( P = 0.008 ) .


Patients in the spinal anaesthesia group fulfilled the discharge criteria from the post-operative care unit earlier compared with the general anaesthesia patients ( P = 0.004 ) .


General anaesthesia patients requested a change in the method of anaesthesia for a subsequent operation less often than the spinal anaesthesia patients ( 5 vs. 13 , P = 0.022 ) .


General anaesthesia resulted in a more favourable recovery profile compared with spinal anaesthesia .


Why do limb tourniquets cause pain ?


If ischemia is the mechanism , can supplemental oxygen reduce pain ?


The Reducing Tourniquet Associated Pain study investigated whether this simple treatment could extend tourniquet tolerance time to facilitate hand surgery under local or regional anesthesia .


The Reducing Tourniquet Associated Pain study was a double-blind , randomized , controlled trial of healthy volunteers .


Participants received either 50 % inhaled oxygen or air placebo via a face mask for 3 minutes before and up to 30 minutes after upper arm tourniquet inflation to 250 mmHg .


Pain scores were recorded at 2-minute intervals using a validated 100-mm visual analogue scale .


The primary outcomes were ( 1 ) difference in visual analogue scale score and ( 2 ) difference in time taken to reach visual analogue score of 40 mm or more in oxygen and air groups .


Fifty participants enrolled and , after exclusion criteria were applied , 46 were analyzed ( oxygen , n = 23 ; air , n = 23 ) .


Oxygen supplementation was associated with a 29 percent mean reduction in pain on visual analogue scoring compared with air placebo over the entire period of inhalation ( p = 0.027 ) .


Oxygen also extended the time to visual analogue scale score of 40 mm or more by a mean of 6 minutes compared with air placebo ( p = 0.008 ) .


Oxygen is a readily available , low-risk , low-cost treatment that significantly reduced tourniquet-associated pain in this study and significantly increased the time taken to reach visual analogue scale score of 40 or more .


The authors recommend oxygen to facilitate hand surgery under a tourniquet and when a regional block fails to control tourniquet pain .


Pruritus is the hallmark clinical sign of atopic dermatitis ( AD ) in dogs .


Preliminary study results suggest that oclacitinib , a selective Janus kinase inhibitor , could reduce pruritus and associated inflammatory skin lesions in dogs with AD .


The objective was to evaluate efficacy and safety of oclacitinib ( Apoquel ) for the control of AD in a randomized , double-blind , placebo-controlled trial .


Clinicians at 18 specialty clinics enrolled client-owned dogs ( n = 299 ) with a history of chronic AD .


Dogs were randomized to receive either oclacitinib ( 0.4-0 .6 mg/kg twice daily for 14 days and then once daily for up to 112 days ) or an excipient-matched placebo .


Owners assessed visual analog scale ( VAS ) scores of pruritus on days 0 , 1 , 2 , 7 , 14 , 28 , 56 , 84 and 112 .


Clinicians assessed Canine AD Extent and Severity Index ( CADESI-02 ) scores on days 0 , 14 , 28 , 56 , 84 and 112 .


On days 1 , 2 , 7 , 14 and 28 , oclacitinib-treated dogs had a 29.5 , 42.3 , 61.5 , 66.7 and 47.4 % reduction from baseline in owner-assessed pruritus scores , respectively , compared with a 6.5 , 9.1 , 6.5 , 3.9 and 10.4 % reduction in placebo-treated dogs .


On days 14 and 28 , dermatologists recorded a 48.4 % reduction in CADESI-02 scores in oclacitinib-treated dogs compared with a 1.7 % reduction and a 3.6 % increase in placebo-treated dogs .


After day 28 , > 86 % of all placebo-treated dogs had moved to an open-label study , making between-group comparisons biased .


Differences were significant at all time points assessed ( P < 0.0001 ) .


Oclacitinib provided rapid , effective and safe control of AD , with substantial improvement in VAS and CADESI-02 scores .


Systemic administration of dexmedetomidine has been shown to reduce opioid consumption and improve analgesia satisfaction .


The purpose of this study was to investigate the effect of intrathecal dexmedetomidine on spinal morphine analgesia in patients with refractory cancer pain .


A double-blinded crossover study was designed and performed .


Patients were randomly allocated in one of the two phases .


Phase M received intrathecal morphine administration .


Phase M+D received intrathecal morphine plus dexmedetomidine administration .


All patients were monitored for 7 days and crossed over to alternate phase for another 1-week observation .


Daily average visual analog scale ( VAS ) pain score , pain frequency , sleep deprivation , daily morphine consumption , bolus dose injection times , and side effects were all recorded .


Pain intensity and frequency were significantly decreased in both phases compared with baseline .


Daily morphine consumption and bolus dose injection times during phase M+D were significantly decreased compared with phase M.


The incidences of constipation were significantly reduced in both phases compared with baseline administration , but nausea and vomiting were significantly increased .


No serious side effects such as respiratory inhibition were observed in this study .


Intrathecal administration of dexmedetomidine and morphine reduced the morphine consumption in patients with refractory cancer pain .


There were no serious side effects .


With little scientific evidence to support use of aromatherapy for postoperative nausea and/or vomiting ( PONV ) symptoms , this study evaluated controlled breathing with peppermint aromatherapy ( AR ) and controlled breathing alone ( CB ) for PONV relief .


A single blind randomized control trial design was used .


On initial PONV complaint , symptomatic subjects received either CB ( n = 16 ) or AR ( n = 26 ) intervention based on randomization at enrollment .


A second treatment was repeated at 5 minutes if indicated .


Final assessment occurred 10 minutes post initial treatment .


Rescue medication was offered for persistent symptoms .


Among eligible subjects , PONV incidence was 21.4 % ( 42/196 ) .


Gender was the only risk factor contributing to PONV symptoms ( P = .0024 ) .


Though not statistically significant , CB was more efficacious than AR , 62.5 % versus 57.7 % , respectively .


CB can be initiated without delay as an alternative to prescribed antiemetics .


Data also support use of peppermint AR in conjunction with CB for PONV relief .


This randomized crossover trial aimed to compare the effects of 2 different protocols using pedometers and informative booklets to increase physical activity in daily life ( PADL ) in smokers .


PADL level was assessed at baseline ( A1 ) , and subjects were randomly assigned to 2 groups for a month : booklet + pedometer ( GB + P ; n = 13 ) , which started the protocol receiving a booklet with encouragement to walk as much as possible in everyday life ; pedometer + booklet ( GP + B ; n = 18 ) , which started the protocol wearing a pedometer aiming to achieve 10,000 steps/day .


PADL was reassessed ( A2 ) , and the interventions were crossed over for 1 month , followed by PADL reassessment ( A3 ) .


After A3 , both groups used pedometers for 3 months aiming to reach 10,000 steps/day , and final PADL assessment was performed ( A4 ) .


For the analysis , each group was subdivided according to baseline PADL as physically active or inactive , according to having reached or not reached 10,000 steps/day at baseline .


The physically active subgroups of GB + P and GP + B showed no change in steps/day .


The physically inactive subgroup of GP + B significantly increased steps/day at A2 and maintained this increase until A4 .


The physically inactive subgroup of GB + P initially increased to a lesser extent , reaching borderline statistical significance at A2 and A3 ( p = .06 ) and statistically significant increase only at A4 ( p = .02 ) .


Both strategies were effective in increasing the number of steps/day in physically inactive smokers after 5 months , although the increase was more quickly obtained in smokers who used pedometers as the first intervention .


To clarify the effectiveness of second-look endoscopy ( SLE ) at preventing bleeding after gastric endoscopic submucosal dissection ( ESD ) .


A multicentre prospective randomised controlled non-inferiority trial was conducted at five referral institutions across Japan .


Patients with a solitary gastric neoplasm were enrolled .


Exclusion criteria were previous oesophagogastric surgery or radiation therapy ; perforation and the administration of antithrombotics , steroids or non-steroidal anti-inflammatory drugs .


Patients were assigned to the SLE group or the non-SLE group by a computer-generated random sequence after ESD and were treated perioperatively with a proton pump inhibitor .


SLE was performed one day after ESD .


The primary endpoint was post-ESD bleeding , defined as an endoscopically proven haemorrhage .


The trial had the power to detect a non-inferiority criterion of 7 % between the groups .


From February 2012 to February 2013 , 130 and 132 patients were assigned to the SLE and the non-SLE groups , respectively .


All patients were included in the intention-to-treat analysis of the primary endpoint .


Post-ESD bleeding occurred in seven patients with ( 5.4 % ) SLE and five patients with ( 3.8 % ) non-SLE ( risk difference -- 1.6 % ( 95 % CI -6.7 to 3.5 ) ; pnon-inferiority < 0.001 ) , meeting the non-inferiority criterion .


All 12 patients with post-ESD bleeding and one patient with a delayed perforation were successfully managed with conservative treatment .


SLE after gastric ESD is not routinely recommended because it does not contribute to the prevention of post-ESD bleeding for patients with an average bleeding risk .


UMIN-CTR000007170 .


The response of diastolic Doppler indices to exercise is not well defined for young subjects .


The aims of this study were to evaluate this in nonathletic and endurance-trained probands and to correlate echocardiographic data with maximal oxygen consumption .


In this prospective study , Doppler echocardiography was performed at rest and after exercise in 40 nonathletes ( NAs ) and 20 endurance-trained athletes ( ETs ) aged < 40 years , matched for age and gender .


Diastolic function was assessed by mitral inflow and early diastolic velocities of the septal ( e ' septal ) and lateral ( e ' lateral ) mitral annulus .


Maximal oxygen consumption quantification was performed simultaneously .


All cardiac chambers were larger in ETs than NAs .


ETs had higher e ' lateral at rest ( 18.1 2.7 vs 16.3 3.3 cm/sec , P = .02 ) and higher mitral E ( 141 15 vs 132 15 cm/sec , P = .02 ) and e ' lateral ( 23.5 2.5 vs 21.4 3.0 cm/sec , P = .01 ) with exercise than NAs .


There was a slight increase in E/e ' septal ( overall , from 6.8 1.3 to 7.2 1.2 ; P = .02 ) and E/e ' lateral ( overall , from 5.0 0.8 to 6.2 0.9 ; P < .0001 ) with exercise .


Changes in diastolic parameters with exercise were similar in ETs and NAs .


Percentage of predicted maximal oxygen consumption was correlated with exertional E ( r = 0.28 , P = .03 ) and e ' lateral ( r = 0.32 , P = .01 ) , but the strongest predictor was indexed left ventricular end-diastolic volume ( r = 0.66 , P < .0001 ) .


During exercise , E/e ' increases but remains within normal ranges in healthy young subjects , and the response to exercise does not differ between ETs and NAs .


These data help define the normal diastolic stress echocardiographic response in the young .


Exercise capacity shows a correlation with enhanced exertional early diastolic velocities but is more closely related to cardiac structural adaption to endurance training .


Concept maps have been used to promote meaningful learning and critical thinking .


Although these are crucially important in all disciplines , evidence for the benefits of concept mapping for learning in medicine is limited .


We performed a randomised crossover study to assess the benefits of online testable concept maps for learning in pathology by volunteer junior medical students .


Participants ( n = 65 ) were randomly allocated to either of two groups with equivalent mean prior academic performance , in which they were given access to either online maps or existing online resources for a 2-week block on renal disease .


Groups then crossed over for a 2-week block on hepatic disease .


Outcomes were assessed using timed online quizzes , which included questions unrelated to topics in the pathogenesis maps as an internal control .


Questionnaires were administered to evaluate students ' acceptance of the maps .


In both blocks , the group with access to pathogenesis maps achieved significantly higher average scores than the control group on quiz questions related to topics covered by the maps ( Block 1 : p < 0.001 , Cohen 's d = 0.9 ; Block 2 : p = 0.008 , Cohen 's d = 0.7 ) .


However , mean scores on unrelated questions did not differ significantly between the groups .


In a third block on pancreatic disease , both groups received pathogenesis maps and collectively performed significantly better on quiz topics related to the maps than on unrelated topics ( p < 0.01 , Cohen 's d = 0.5 ) .


Regression analysis revealed that access to pathogenesis maps was the dominant contributor to variance in performance on map-related quiz questions .


Responses to questionnaire items on pathogenesis maps were overwhelmingly positive in both groups .


These results indicate that online testable pathogenesis maps are well accepted and can improve learning of concepts in pathology by medical students .


Positional therapy ( PT ) is an effective therapy in positional obstructive sleep apnea syndrome ( POSAS ) when used , but the compliance of PT is low .


The objective of this study was to investigate whether a new kind of PT is effective and can improve compliance .


29 patients were treated with the Sleep Position Trainer ( SPT ) , 26 patients with the Tennis Ball Technique ( TBT ) .


At baseline and 1 month polysomnography , Epworth Sleepiness Scale ( ESS ) and the Quebec Sleep Questionnaire ( QSQ ) were taken .


Daily compliance was objectively measured in both groups .


Both therapies prevent supine sleep position to a median of 0 % ( min-max : SPT 0.0 % to 67 % , TBT 0.0 % to 38.9 % ) , resulting in a treatment success ( AHI < 5 ) in 68.0 % of the SPT and 42.9 % of the TBT patients .


The ESS at baseline was < 10 in both groups .


Sleep quality parameters as wake after sleep onset ( WASO ; p = 0.001 ) and awakenings ( p = 0.006 ) improved more in the SPT group .


Total QSQ scores ( 0.40.2 , p = 0.03 ) and the QSQ domains nocturnal symptoms ( 0.70.2 , p = 0.01 ) and social interactions ( 0.80.3 , p = 0.02 ) changed in favor of the SPT group .


Effective compliance ( 4 h/night + 5 days/week ) was 75.9 % for the SPT and 42.3 % for the TBT users ( p = 0.01 ) .


In mild POSAS with normal EES the new SPT device and the standard TBT are equally effective in reducing respiratory indices .


However , compared to the TBT , sleep quality , quality of life , and compliance improved significantly more in the SPT group .


Uric acid has been linked to the progression of native kidney disease .


Studies evaluating its contribution to allograft function in kidney transplant recipients , among whom hyperuricemia is common , have yielded mixed results .


We evaluated the association between baseline uric acid and the primary composite outcome of doubling of interstitium or ESRD from interstitial fibrosis and tubular atrophy ( IF/TA ) in the Angiotensin II Blockade for Chronic Allograft Nephropathy ( ABCAN ) Trial participants .


Subjects underwent uric acid , iothalamte GFR , and urine albumin to creatinine ( ACR ) measurements annually for 5 years in addition to an allograft biopsy at baseline and 5 years .


Baseline uric acid was 5.571.48 mg/dL ; male sex , higher BMI , diuretic use , and lower GFR were associated with higher uric acid , whereas older age , less than 3 HLA matches and having a female donor were associated with lower levels .


In multivariate analysis adjusting for baseline GFR , uric acid was associated with doubling of interstitium or ESRD from IF/TA ( OR 1.83 , 95 % CI , 1.06-3 .17 , P = 0.03 ) .


Over time , a 1 mg/dL increase in time-varying uric acid was associated with a 2.39 mL/min lower final GFR ( P < 0.001 ) but not with the secondary outcome of creatinine doubling , ESRD , or death .


These data suggest that uric acid is associated with IF/TA and thus may be a viable target for intervention .


Most orthodontists believe that fixed retainers are necessary to maintain ideal dental relationships .


However , untoward side effects might result from their long-term placement .


The aim of this study was to evaluate the clinical and radiographic effect of two commonly used fixed retainers on the health of the periodontium .


Thirty patients were randomly divided into two groups to receive either a fiber-reinforced composite retainer or a spiral wire retainer extended on the lingual surfaces of both maxillary and mandibular arches from canine to canine .


Periapical radiographs were obtained from the patients at the time of placement of the retainers and after the 6-month period to assess the radiographic conditions of the periodontium .


Clinical examination was carried out at the same two time intervals .


Even though there were no significant differences between the two groups of study at the beginning of the trial , there were statistically significant differences after the 6-month follow-up regarding the main outcomes of the study .


Nearly all indices showed to deteriorate after 6 months in the fiber-reinforced group , while in the spiral wire group , this was not the case .


As for the secondary outcomes , radiographic examination did not reveal any statistically significant differences after 6 months or between the two groups .


It can be concluded that spiral wire retainers elicit less detrimental periodontal response in the short-term follow-up compared to fiber-reinforced composite retainers as revealed by the primary outcomes of the study .


ClinicalTrials.gov : NCT01314729 .


Muscle weakness and fatigue are common symptoms in multiple sclerosis ( MS ) .


Green tea catechins such as ( - ) epigallocatechin-3-gallate ( EGCG ) are known to improve energy metabolism at rest and during exercise .


We tested the hypothesis that EGCG improves energy metabolism and substrate utilization in patients with MS.


Eighteen patients ( 8 men ) with relapsing-remitting MS ( expanded disability status scale score < 4.5 , all receiving glatiramer acetate ) participated in this randomized , double-blind , placebo-controlled , crossover trial at a clinical research center .


All patients received EGCG ( 600 mg/d ) and placebo over 12 wk ( 4-wk washout in between ) .


After each intervention , fasting and postprandial energy expenditure ( EE ) , as well as fat oxidation ( FAOx ) and carbohydrate oxidation ( CHOx ) rates , were measured either at rest or during 40 min of exercise ( 0.5 W/kg ) .


At rest , blood samples and microdialysates from adipose tissue and skeletal muscle were also taken .


At rest , postprandial EE and CHOx , as well as adipose tissue perfusion and glucose supply , were significantly lower in men but higher in women receiving EGCG compared with placebo .


During exercise , postprandial EE was lower after EGCG than after placebo , indicating an increased working efficiency ( men > women ) .


After placebo , exercise EE was mainly fueled by FAOx in both men and women .


After EGCG , there was a shift to a higher and more stable CHOx during exercise in men but not in women .


Our data indicate that EGCG given to patients with MS over 12 wk improves muscle metabolism during moderate exercise to a greater extent in men than in women , possibly because of sex-specific effects on autonomic and endocrine control .


Observational evidence suggests that improving fetal growth may improve adult health .


Experimental evidence from nutritional supplementation trials undertaken amongst pregnant women in the less developed world does not show strong or consistent effects on adult disease risk and no trials from the more developed world have previously been reported .


To test the hypothesis that nutritional supplementation during pregnancy influences offspring disease risk in adulthood .


Clinical assessment of a range of established diseases risk markers in young adult offspring of 283 South Asian mothers who participated in two trials of nutritional supplementation during pregnancy ( protein/energy/vitamins ; energy/vitamins or vitamins only ) at Sorrento Maternity Hospital in Birmingham UK either unselected or selected on the basis of nutritional status .


236 ( 83 % ) offspring were traced and 118 ( 50 % ) of these were assessed in clinic .


Protein/energy/vitamins supplementation amongst undernourished mothers was associated with increased infant birthweight .


Nutritional supplementation showed no strong association with any one of a comprehensive range of markers of adult disease risk and no consistent pattern of association with risk across markers in offspring of either unselected or undernourished mothers .


We found no evidence that nutritional supplements given to pregnant women are an important influence on adult disease risk however our study lacked power to estimate small effects .


Our findings do not provide support for a policy of nutritional supplementation for pregnant women as an effective means to improve adult health in more developed societies .


Impaired cardiac isoform of sarco ( endo ) plasmic reticulum Ca ( 2 + ) ATPase ( SERCA2a ) activity is a key abnormality in heart failure patients with reduced ejection fraction .


The CUPID 2 ( Calcium Up-Regulation by Percutaneous Administration of Gene Therapy in Cardiac Disease Phase 2b ) trial is designed to evaluate whether increasing SERCA2a activity via gene therapy improves clinical outcome in these patients .


Intracoronary delivery of recombinant adeno-associated virus serotype 1 ( AAV1 ) / SERCA2a improves intracellular Ca ( 2 + ) handling by increasing SERCA2a protein levels and , as a consequence , restores systolic and diastolic function .


In a previous phase 2a trial , this therapy improved symptoms , functional status , biomarkers , and left ventricular function , and reduced cardiovascular events in advanced heart failure patients .


CUPID 2 is a phase 2b , double-blind , placebo-controlled , multinational , multicenter , randomized event-driven study in up to 250 patients with moderate-to-severe heart failure with reduced ejection fraction and New York Heart Association functional class II to IV symptoms despite optimal therapy .


Enrolled patients will be at high risk for recurrent heart-failure hospitalizations by virtue of having elevated N-terminal pro-B-type natriuretic peptide/BNP ( > 1,200 pg/ml , or > 1,600 pg/ml if atrial fibrillation is present ) and/or recent heart failure hospitalization .


The primary endpoint of time-to-recurrent event ( heart failure-related hospitalizations in the presence of terminal events [ all-cause death , heart transplant , left ventricular assist device implantation or ambulatory worsening heart failure ] ) will be assessed using the joint frailty model .


This ongoing trial is expected to complete recruitment in 2014 , with the required number of 186 recurrent events estimated to occur by mid 2015 .


Available data indicate that calcium up-regulation by AAV1/SERCA2a gene therapy is safe and of potential benefit in advanced heart failure patients .


The CUPID 2 trial is designed to study the effects of this therapy on clinical outcome in these patients .


( Calcium Up-Regulation by Percutaneous Administration of Gene Therapy in Cardiac Disease Phase 2b [ CUPID-2b ] ; NCT01643330 ) .


The EGF receptor ( EGFR ) and COX2 pathways are upregulated in head and neck squamous cell carcinoma ( HNSCC ) .


Preclinical models indicate synergistic antitumor activity from dual blockade .


We conducted a randomized , double-blind , placebo-controlled window trial of erlotinib , an EGFR inhibitor ; erlotinib plus sulindac , a nonselective COX inhibitor ; versus placebo .


Patients with untreated , operable stage II-IVb HNSCC were randomized 5:5:3 to erlotinib , erlotinib-sulindac , or placebo .


Tumor specimens were collected before and after seven to 14 days of treatment .


The primary endpoint was change in Ki67 proliferation index .


We hypothesized an ordering effect in Ki67 reduction : erlotinib-sulindac > erlotinib > placebo .


We evaluated tissue microarrays by immunohistochemistry for pharmacodynamic modulation of EGFR and COX2 signaling intermediates .


From 2005-2009 , 47 patients were randomized for the target 39 evaluable patients .


Thirty-four tumor pairs were of sufficient quality to assess biomarker modulation .


Ki67 was significantly decreased by erlotinib or erlotinib-sulindac ( omnibus comparison , two-sided Kruskal-Wallis , P = 0.04 ) .


Wilcoxon pairwise contrasts confirmed greater Ki67 effect in both erlotinib groups ( erlotinib-sulindac vs. placebo , P = 0.043 ; erlotinib vs. placebo , P = 0.027 ) .


There was a significant trend in ordering of Ki67 reduction : erlotinib-sulindac > erlotinib > placebo ( two-sided exact Jonckheere-Terpstra , P = 0.0185 ) .


Low baseline pSrc correlated with greater Ki67 reduction ( R ( 2 ) = 0.312 , P = 0.024 ) .


Brief treatment with erlotinib significantly decreased proliferation in HNSCC , with additive effect from sulindac .


Efficacy studies of dual EGFR-COX inhibition are justified .


pSrc is a potential resistance biomarker for anti-EGFR therapy , and warrants investigation as a molecular target .


This study was conducted to determine whether installation of sit-stand desks ( SSDs ) could lead to decreased sitting time during the workday among sedentary office workers .


A randomized cross-over trial was conducted from January to April , 2012 at a business in Minneapolis .


28 ( nine men , 26 full-time ) sedentary office workers took part in a 4 week intervention period which included the use of SSDs to gradually replace 50 % of sitting time with standing during the workday .


Physical activity was the primary outcome .


Mood , energy level , fatigue , appetite , dietary intake , and productivity were explored as secondary outcomes .


The intervention reduced sitting time at work by 21 % ( 95 % CI 18 % -25 % ) and sedentary time by 4.8 min/work-hr ( 95 % CI 4.1-5 .4 min/work-hr ) .


For a 40 h work-week , this translates into replacement of 8 h of sitting time with standing and sedentary time being reduced by 3.2 h. Activity level during non-work hours did not change .


The intervention also increased overall sense of well-being , energy , decreased fatigue , had no impact on productivity , and reduced appetite and dietary intake .


The workstations were popular with the participants .


The SSD intervention was successful in increasing work-time activity level , without changing activity level during non-work hours .


This study sought to determine whether red blood cell ( RBC ) transfusion increases in vivo platelet aggregation and inflammation in coronary and noncoronary patients .


RBC transfusion increases in vitro platelet activation and aggregation in healthy volunteers , providing a possible explanation for the increase in recurrent ischemic events and mortality reported after RBC transfusion in patients with acute coronary syndromes ( ACS ) .


Platelet reactivity was measured before and after RBC transfusion in 61 patients ( 33 with ACS patients and 28 without ACS ) .


Relative changes between baseline and post-transfusion measurements of maximal and residual platelet aggregation were considered with different agonists as well as changes in vasodilator-stimulated phosphoprotein platelet reactivity index and P-selectin expression .


Inflammatory and thrombotic biomarkers were also measured before and after transfusion .


After RBC transfusion , platelet reactivity was increased when measured using adenosine diphosphate-induced light transmission aggregometry ( 11.6 % relative increase in maximal platelet aggregation , p = 0.004 ; 10.8 % increase in residual platelet aggregation , p = 0.005 ) and vasodilator-stimulated phosphoprotein platelet reactivity index ( 20.7 % relative increase , p = 0.002 ) , and there was a nonsignificant trend toward an increase in P-selectin expression .


Similar results were found with the nonspecific agonist thrombin receptor-activated peptide ( relative increases of 11.7 % for maximal platelet aggregation , p = 0.04 , and 12.7 % for residual platelet aggregation , p = 0.02 ) but not with collagen or arachidonic acid agonists .


There were no significant differences in inflammatory and thrombotic biomarkers before and after transfusion .


After RBC transfusion , there is an increase in platelet reactivity , especially with tests measuring the adenosine diphosphate-P2Y12 receptor pathway , without significant variations in inflammatory or thrombotic biomarkers .


This in vivo effect may account for the excess of ischemic events observed in the context of patients with ACS treated using percutaneous coronary intervention and P2Y12 inhibitors .


To evaluate the short-term digestive tolerance and glycaemic response of several associations of maltitol and short-chain fructo-oligosaccharides ( scFOS ) used to replace sugars ( for example , dextrose ) in foods .


Thirty-six healthy subjects aged 18-60 years were recruited for the study and 32 completed it .


The subjects consumed six different mixtures of dextrose , maltitol and scFOS added in a chocolate dairy dessert at a dosage of 35g .


The test days were separated by 2-week washout periods .


The subjects reported the intensity of four individual gastrointestinal ( GI ) symptoms , number of bowel movements and stool frequency for the 48h following consumption of the dessert .


A subgroup of 18 subjects also provided blood samples 2h after intake to evaluate the postprandial glycaemic and insulinaemic responses .


The composite score calculated from the intensity of flatulence , borborygmi , bloating and discomfort was significantly higher ( P < 0.0001 ) for all the desserts containing maltitol and/or scFOS than for the control dessert containing dextrose , but remains at the level of mild effects .


The number of bowel movements was also slightly increased ( P = 0.0006 ) and the stools were softer ( P = 0.0045 ) for the first 24h but not after ( P = 0.1373 and 0.5420 , respectively ) .


Blood glycaemic and insulinaemic responses were lower for all the sugar-free recipes containing maltitol and scFOS in comparison to the control one ( P < 0.0001 ) .


This study has shown that maltitol and scFOS can be used jointly when formulating sugar-free foods with the benefit to lower postprandial glycaemic response with only a small and transient increase in non-serious GI symptoms .


Endemic malaria and helminth infections in sub-Saharan Africa can act as immunological modulators and impact responses to standard immunizations .


We conducted a cohort study to measure the influence of malaria and helminth infections on the immunogenicity of the bivalent HPV-16 / 18 vaccine .


We evaluated the association between malaria and helminth infections , and HPV-16 / 18 antibody responses among 298 Tanzanian females aged 10-25 years enrolled in a randomized controlled trial of the HPV-16 / 18 vaccine .


Malaria parasitaemia was diagnosed by examination of blood smears , and helminth infections were diagnosed by examination of urine and stool samples , respectively .


Geometric mean antibody titres ( GMT ) against HPV-16 / 18 antibodies were measured by enzyme-linked immunosorbent assay .


Parasitic infections were common ; one-third ( 30.4 % ) of participants had a helminth infection and 10.2 % had malaria parasitaemia .


Overall , the vaccine induced high HPV-16 / 18 GMTs , and there was no evidence of a reduction in HPV-16 or HPV-18 GMT at Month 7 or Month 12 follow-up visits among participants with helminths or malaria .


There was some evidence that participants with malaria had increased GMTs compared to those without malaria .


The data show high HPV immunogenicity regardless of the presence of malaria and helminth infections .


The mechanism and significance for the increase in GMT in those with malaria is unknown .


Polymorphic light eruption ( PLE ) is the most common photodermatosis .


Little is known about the efficacy of systemic photoprotection provided by nutritional supplements in PLE patients .


The purpose of this study was to assess efficacy of nutritional supplement containing lycopene , - carotene , and Lactobacillus johnsonii to diminish skin lesions induced by ` photoprovocation ' testing in PLE patients .


In this randomized , placebo-controlled , double-blinded study , 60 PLE patients were supplemented with the nutritional supplement or placebo .


For inducing skin lesions , patient skin was exposed to single daily doses of 100J/cm2 ultraviolet A1 ( UVA1 ) for two consecutive days .


Skin lesions were evaluated using a PLE score .


Skin biopsies were taken before and after supplementation from unexposed and exposed skin , and intercellular adhesion molecule 1 ( ICAM-1 ) mRNA expression was assessed by real-time polymerase chain reaction .


Prior to supplementation , skin lesions were induced in all patients with comparable PLE scores .


After 12 weeks , intake of the supplement significantly reduced the PLE score after one exposure as compared with patients taking placebo ( P < 0.001 ) .


After two exposures , these differences were no longer significant .


At a molecular level , the development of skin lesions was associated with an increased expression of ICAM-1 mRNA , which was significantly reduced after supplementation ( P = 0.022 ) , but not with placebo .


The nutritional supplement provides protection against the development of UVA-induced PLE lesions at clinical and molecular levels .


DECISION + 2 , a training program for physicians , is designed to implement shared decision making ( SDM ) in the context of antibiotics use for acute respiratory tract infections ( ARTIs ) .


We evaluated the impact of DECISION + 2 on SDM implementation as assessed by patients and physicians , and on physicians ' intention to engage in SDM .


From 2010 to 2011 , a multi-center , two-arm , parallel randomized clustered trial appraised the effects of DECISION + 2 on the decision to use antibiotics for patients consulting for ARTIs .


We randomized 12 family practice teaching units ( FPTUs ) to either DECISION + 2 or usual care .


After the consultation , both physicians and patients independently completed questionnaires based on the D-Option scale regarding SDM behaviors during the consultation .


Patients also answered items assessing the role they assumed during the consultation ( active/collaborative/passive ) .


Before and after the intervention , physicians completed a questionnaire based on the Theory of Planned Behavior to measure their intention to engage in SDM .


To account for the cluster design , we used generalized estimating equations and generalized linear mixed models to assess the impact of DECISION + 2 on the outcomes of interest .


A total of 270 physicians ( 66 % women ) participated in the study .


After DECISION + 2 , patients ' D-Option scores were 80.1 1.1 out of 100 in the intervention group and 74.9 1.1 in the control group ( p = 0.001 ) .


Physicians ' D-Option scores were 79.7 1.8 in the intervention group and 76.3 1.9 in the control group ( p = 0.2 ) .


However , subgroup analyses showed that teacher physicians D-Option scores were 79.7 1.5 and 73.0 1.4 respectively ( p = 0.001 ) .


More patients reported assuming an active or collaborative role in the intervention group ( 67.1 % ) , than in the control group ( 49.2 % ) ( p = 0.04 ) .


There was a significant relation between patients ' and physicians ' D-Option scores ( p < 0.01 ) and also between patient-reported assumed roles and both D-Option scores ( as assessed by patients , p < 0.01 ; and physicians , p = 0.01 ) .


DECISION + 2 had no impact on the intention of physicians to engage in SDM .


DECISION + 2 positively influenced SDM behaviors as assessed by patients and teacher physicians .


Physicians ' intention to engage in SDM was not affected by DECISION + 2 .


ClinicalTrials.gov trials register no .


NCT01116076 .


To compare the efficacy of fentanyl administered via the subcutaneous ( s.c. ) or intranasal ( i.n. ) route with intramuscular ( i.m. ) pethidine in labouring women requesting analgesia .


A randomised controlled trial three-armed , parallel-design .


A regional hospital and the largest tertiary maternity centre in South Australia .


One hundred and fifty-six healthy parturients birthing at term .


Women were randomised to receive s.c. fentanyl ( n = 53 ) , i.n. fentanyl ( n = 52 ) , or i.m. pethidine ( n = 51 ) .


The outcomes were analysed by intention-to-treat .


Pain scores measured before and 30 minutes after opioid administration .


All groups reported clinically significant reductions in pain scores ( mean range 1.2-1 .6 ; P < 0.001 ) , with no significant differences between groups .


Significantly more women in the fentanyl groups reported satisfaction with using the study drug again , compared with women receiving i.m. pethidine ( 82.9 % i.n. fentanyl , 80.6 % s.c. fentanyl , and 44.0 % i.m. pethidine ; P < 0.01 ) .


Women in the fentanyl groups experienced less sedation ( i.n. fentanyl 7.3 % , s.c. fentanyl 2.9 % , i.m. pethidine 44 % ; P 0.03 ) , shorter labours by at least 2 hours ( P < 0.05 ) , and fewer difficulties establishing breastfeeding ( 78.8 % i.m. pethidine , 39.4 % i.n. fentanyl , and 44.0 % s.c. fentanyl ; P < 0.01 ) .


Neonates in the pethidine group were more likely to require nursery admission ( P < 0.02 ) .


Fentanyl administered by s.c. and i.n. routes is as efficacious in relieving labour pain as i.m. pethidine , but resulted in greater satisfaction , less sedation , shorter labour , fewer nursery admissions , and fewer difficulties in establishing breastfeeding .


Fentanyl appears to be a suitable alternative to pethidine when providing parenteral pain relief to labouring women .


Prior studies adjusting self-reported measures of alcohol intake for drink size and ethanol ( EtOH ) content have relied on single-point assessments .


A prospective 28-day diary study investigated magnitudes of drink-EtOH adjustments and factors associated with these adjustments .


Transdermal alcohol sensor ( TAS ) readings and prediction of alcohol-related problems by number of drinks versus EtOH-adjusted intake were used to validate drink-EtOH adjustments .


Self-completed event diaries listed up to 4 beverage types and 4 drinking events/d .


Eligible volunteers had weekly drinking and 3 + drinks per occasion with 26 reported days and pre - and postsummary measures ( n = 220 ) .


Event reports included drink types , sizes , brands or spirits contents , venues , drinks consumed , and drinking duration .


Wine drinks averaged 1.19 , beer 1.09 , and spirits 1.54 U.S. standard drinks ( 14g EtOH ) .


Mean-adjusted alcohol intake was 22 % larger using drink size and strength ( brand/EtOH concentration ) data .


Adjusted drink levels were larger than `` raw '' drinks in all quantity ranges .


Individual-level drink-EtOH adjustment ratios ( EtOH adjusted/unadjusted amounts ) averaged across all days drinking ranged from 0.73 to 3.33 ( mean 1.22 ) .


Adjustment ratio was only marginally ( and not significantly ) positively related to usual quantity , frequency , and heavy drinking ( all ps < 0.10 ) , independent of gender , age , employment , and education , but those with lower incomes ( both p < 0.01 ) drank stronger/bigger drinks .


Controlling for raw number of drinks and other covariates , degree of adjustment independently predicted alcohol dependence symptoms ( p < 0.01 ) and number of consequences ( p < 0.05 ) .


In 30 respondents with sufficiently high-quality TAS readings , higher correlations ( p = 0.04 ) were found between the adjusted versus the raw drinks/event and TAS areas under the curve .


Absent drink size and strength data , intake assessments are downward biased by at least 20 % .


Between-subject variation in typical drink content and pour sizes should be addressed in treatment and epidemiological research .


T-cell activation independently predicts mortality , poor immune recovery and non-AIDS illnesses during combination antiretroviral therapy ( cART ) .


Atorvastatin showed anti-immune activation effects among HIV-infected cART-nave individuals .


We investigated whether adjunct atorvastatin therapy reduces T-cell activation among cART-treated adults with suboptimal immune recovery .


A randomised double-blind placebo-controlled crossover trial , of atorvastatin 80 mg daily vs. placebo for 12 weeks , was conducted among individuals with CD4 increase < 295 cells/l after seven years of suppressive cART .


Change in T-cell activation ( CD3 + CD4 + / CD8 + CD38 + HLADR + ) and in T-cell exhaustion ( CD3 + CD4 + / CD8 + PD1 + ) was measured using flow cytometry .


Thirty patients were randomised , 15 to each arm .


Atorvastatin resulted in a 28 % greater reduction in CD4 T-cell activation ( 60 % reduction ) than placebo ( 32 % reduction ) ; P = 0.001 .


Atorvastatin also resulted in a 35 % greater reduction in CD8-T-cell activation than placebo ( 49 % vs. 14 % , P = 0.0009 ) , CD4 T-cell exhaustion ( 27 % vs. 17 % in placebo ) , P = 0.001 and CD8 T-cell exhaustion ( 27 % vs. 16 % ) , P = 0.004 .


There was no carry-over/period effect .


Expected adverse events were comparable in both groups , and no serious adverse events were reported .


Atorvastatin reduced T-cell immune activation and exhaustion among cART-treated adults in a Ugandan cohort .


Atorvastatin adjunct therapy should be explored as a strategy to improve HIV treatment outcomes among people living with HIV in sub-Saharan Africa .


Among the multiple conservative modalities , physiotherapy is a commonly utilized treatment modality in managing chronic non-specific spinal pain .


Despite the scientific progresses with regard to pain and motor control neuroscience , treatment of chronic spinal pain ( CSP ) often tends to stick to a peripheral biomechanical model , without targeting brain mechanisms .


With a view to enhance clinical efficacy of existing physiotherapeutic treatments for CSP , the development of clinical strategies targeted at ` training the brain ' is to be pursued .


Promising proof-of-principle results have been reported for the effectiveness of a modern neuroscience approach to CSP when compared to usual care , but confirmation is required in a larger , multi-center trial with appropriate evidence-based control intervention and long-term follow-up .


The aim of this study is to assess the effectiveness of a modern neuroscience approach , compared to usual care evidence-based physiotherapy , for reducing pain and improving functioning in patients with CSP .


A secondary objective entails examining the effectiveness of the modern neuroscience approach versus usual care physiotherapy for normalizing brain gray matter in patients with CSP .


The study is a multi-center , triple-blind , two-arm ( 1:1 ) randomized clinical trial with 1-year follow-up .


120 CSP patients will be randomly allocated to either the experimental ( receiving pain neuroscience education followed by cognition-targeted motor control training ) or the control group ( receiving usual care physiotherapy ) , each comprising of 3 months treatment .


The main outcome measures are pain ( including symptoms and indices of central sensitization ) and self-reported disability .


Secondary outcome measures include brain gray matter structure , motor control , muscle properties , and psychosocial correlates .


Clinical assessment and brain imaging will be performed at baseline , post-treatment and at 1-year follow-up .


Web-based questionnaires will be completed at baseline , after the first 3 treatment sessions , post-treatment , and at 6 and 12-months follow-up .


Findings may provide empirical evidence on : ( 1 ) the effectiveness of a modern neuroscience approach to CSP for reducing pain and improving functioning , ( 2 ) the effectiveness of a modern neuroscience approach for normalizing brain gray matter in CSP patients , and ( 3 ) factors associated with therapy success .


Hence , this trial might contribute towards refining guidelines for good clinical practice and might be used as a basis for health authorities ' recommendations .


ClinicalTrials.gov Identifier : NCT02098005 .


Stroke is a major cause of long-term adult disability with many survivors living in the community relying on family members for on-going support .


However , reports of inadequate understanding of rehabilitation techniques are common .


A self-management DVD-based observational learning tool may help improve functional outcomes for survivors of stroke and reduce caregivers ' burden .


This article describes the methodology of the stroke self-management rehabilitation trial .


The overall aim of this pilot trial is to assess the feasibility and preliminary efficacy of a DVD-based intervention for improving functional outcomes of survivors of stroke 2 months postrandomization to inform the design of a full-scale randomized clinical trial .


Recruitment of a minimum of 20 survivors of stroke and their informal caregivers ( where available ) in each of the participating centers will occur across multiple international sites .


After baseline assessments , participants will be randomly assigned to an intervention or standard care group .


The intervention comprises a structured DVD observation and practice schedule over 8 weeks .


All participants will complete follow-up assessments .


The outcome measures will include a global shift in the Rankin Scale scores and dichotomized scores , changes in quality of life , general health , depression , and caregiver burden at 2 months postrandomization .


A qualitative analysis of the effects of the intervention will also be undertaken .


The results of the pilot study will provide knowledge of whether observational learning techniques delivered via DVD can effectively improve recovery after stroke and reduce caregiver burden .


Ankle sprain is the most common sports-related injury with a high rate of recurrence and associated costs .


Recent studies have emphasised the effectiveness of both neuromuscular training and bracing for the secondary prevention of ankle sprains .


To evaluate the effectiveness of combined bracing and neuromuscular training , or bracing alone , against the use of neuromuscular training on recurrences of ankle sprain after usual care .


384 athletes , aged 18-70 , who had sustained a lateral ankle sprain , were included ( training group n = 120 ; brace group n = 126 ; combi group n = 138 ) .


The training group received an 8-week home-based neuromuscular training programme , the brace group received a semirigid ankle brace to be worn during all sports activities for 12months , and the combi group received both the training programme , as well as the ankle brace , to be worn during all sports activities for 8 weeks .


The main outcome measure was self-reported recurrence of the ankle sprain .


During the 1-year follow-up , 69 participants ( 20 % ) reported a recurrent ankle sprain : 29 ( 27 % ) in the training group , 17 ( 15 % ) in the brace group and 23 ( 19 % ) in the combi group .


The relative risk for a recurrent ankle sprain in the brace group versus the training group was 0.53 ( 95 % CI 0.29 to 0.97 ) .


No significant differences were found for time losses or costs due to ankle sprains between the intervention groups .


Bracing was superior to neuromuscular training in reducing the incidence but not the severity of self-reported recurrent ankle sprains after usual care .


Recruiting cancer patients is a barrier often encountered in research trials .


However , very few randomized trials explore strategies to improve participation rates .


The purpose of this study was to evaluate the effectiveness of a pre-recruitment primer letter to recruit persons diagnosed with colorectal cancer for a research trial .


Potentially eligible participants were identified by the Victorian Cancer Registry .


A total of 1,062 participants were randomized to receive either a mailed explanatory primer letter designed to encourage research participation , or no primer letter .


Two weeks after the intervention , the Victorian Cancer Registry sought permission from patients to release their contact details to researchers .


Those who agreed were contacted and invited to the study .


Pre-recruitment encouragement was not effective at increasing recruitment , with no significant differences demonstrated between experimental groups .


Overall , 40 % ( n = 425 ) consented to participate , 25 % ( n = 243 ) refused and 35 % ( n = 394 ) did not respond .


While this study demonstrated disappointing outcomes , pre-recruitment letters should not be ruled out as an approach altogether .


Rather , future research should explore whether other factors to increase motivation , such as intensity and timing , are feasible and acceptable for contacting cancer patients .


Australian and New Zealand Clinical Trials Registry , ACTRN12609000628246 .


Endoscopic retrograde cholangiopancreatography ( ERCP ) is associated with radiation exposure to the endoscopist and staff that may be significant in high-volume centers .


We investigated whether a radiation-attenuating drape over the fluoroscopy image intensifier reduces radiation exposure during ERCP .


We performed a prospective , randomized , double-blind trial of 100 therapeutic ERCPs at a tertiary-care university center .


Procedures were randomly assigned to groups receiving lead-free radiation-attenuating drapes ( n = 50 ) or identical sham drapes ( n = 50 ) .


The drapes were suspended around the fluoroscopy image intensifier during ERCP .


The primary end point was the effective dose of radiation measured at the endoscopist 's eye and neck , and at the assisting nurse 's neck .


The cumulative annual radiation exposure was also estimated .


Fluoroscopy time , absorbed radiation dose , and dose area product were similar in the study groups .


Mean effective dose for sham vs. radiation-attenuating drape was 0.210.27 vs. 0.020.02 mSv at the endoscopist 's eye , 0.350.44 vs. 0.030.03 mSv at the endoscopist 's neck , and 0.270.34 vs. 0.020.02 mSv at the nurse 's neck ( P < 0.0001 for all comparisons ) .


The relative risk reduction in radiation was 90 % , 91 % , and 93 % at the three sites .


At a high-volume center in which an endoscopist performs 500 therapeutic ERCPs per year , the estimated cumulative annual effective dose at the endoscopist 's eye level is 126mSv with conventional protection and 12mSv with a radiation-attenuating drape , with the recommended limit being 20mSv .


The addition of a radiation-attenuating drape around the image intensifier during ERCP significantly decreases radiation exposure to endoscopists and staff by 90 % .


The ALIGN study ( NCT01061723 ) evaluated the efficacy and safety of sarilumab , the first fully human monoclonal antibody against interleukin-6 receptor - ( IL-6R ) , in patients with ankylosing spondylitis ( AS ) .


Patients with active AS despite conventional treatment were randomised to placebo , or one of five subcutaneous dose regimens of sarilumab ( 100 , 150 or 200mg every other week , or 100 or 150mg every week ) , for 12weeks .


The primary efficacy end point was the percentage of patients achieving the Axial SpondyloArthritis international Society ( ASAS ) 20 response criteria at week 12 .


Secondary endpoints included ASAS40 response , ASAS partial remission , AS Disease Activity Score , high-sensitivity C-reactive protein ( hs-CRP ) value , and safety .


Baseline demographic and disease characteristics of the 301 patients enrolled were similar across treatment groups .


At week 12 , there was no statistically significant difference in ASAS20 response rate between placebo ( ASAS20 = 24.0 % ) and any sarilumab dose group .


A significantly greater reduction in hs-CRP value was achieved with the higher sarilumab doses versus placebo .


No other statistically significant differences were evident for secondary efficacy endpoints .


The most common treatment-emergent adverse events reported for sarilumab included infections ( non-serious ) , neutropenia , and increase in alanine aminotransferase .


No cases of tuberculosis , opportunistic , or fungal infections , or bowel perforations were reported .


Seven patients experienced a treatment-emergent serious adverse event ( all in sarilumab treatment groups ) .


No deaths occurred .


The ALIGN study shows that IL-6R blockade with sarilumab was not an effective treatment for AS .


Sarilumab was generally well tolerated with a manageable safety profile .


A new formulation of tacrolimus that is characterized by prolonged release has been developed to facilitate treatment and patient compliance .


Initial therapy with prolonged release formula in heart transplantation is not widely accepted .


We enrolled 19 patients into a randomized analysis divided into 2 groups with different initial regimens .


There were 8 patients with a mean age of 44 13 years treated by Advagraf , and 11 patients with a mean age of 41 9 years treated by Prograf .


Serum concentration of immunosuppressive drug was followed by its oral dosage and endomyocardial biopsy results .


Arterial hypertension , kidney function , and incidence of diabetes mellitus were recorded .


There were no perioperative deaths .


The risk of acute rejection within 6 months following surgery was 1 ( 2 % ) in the Advagraf group and 1 ( 1.5 % ) in the Prograf group .


Although the serum tacrolimus results were comparable between groups , the drug 's daily dosages were different after 6 months of therapy ( 3 1 mg in the Advagraf group and 6 2 mg in the Prograf group ( p < 0.05 ) .


The low rate of adverse effects throughout the study was noted .


Prolonged-release tacrolimus formula is an efficient immunosuppressant in heart transplantation .


Its initial application after surgery has low risk of adverse effects with similar results to conventional formula .


This small study has determined the effect of vitamin C on myocardial reperfusion in patients undergoing elective percutaneous coronary intervention ( PCI ) .


This study was to explore whether antioxidant vitamin C infusion before the procedure is able to affect the incidence of periprocedural myocardial injury ( PMI ) in patients undergoing PCI .


In this prospective single-centre randomized study , 532 patients were randomized into 2 groups : the vitamin C group , which received a 3-g vitamin C infusion within 6 hours before PCI , and a control group , which received normal saline .


The primary end point was the troponin I-defined PMI , and the second end point was the creatine kinase ( CK ) - MB-defined PMI .


Separate analyses using both end points were performed .


PMI was defined as an elevation of cardiac biomarker values ( CK-MB or troponin I ) > 5 times the upper limit of normal ( ULN ) , alone or associated with chest pain or ST-segment or T-wave changes .


After PCI , the incidence of PMI was reduced , whether defined by troponin or by CK-MB , compared with the control group ( troponin I , 10.9 % vs 18.4 % ; P = 0.016 ; CK-MB , 4.2 % vs 8.6 % ; P = 0.035 ) .


Logistic multivariate analysis showed that preprocedure use of vitamin C is an independent predictor of PMI either defined by troponin I ( odds ratio [ OR ] , 0.56 ; 95 % confidence interval [ CI ] , 0.33-0 .97 ; P = 0.037 ) or by CK-MB ( OR , 0.37 ; 95 % CI , 0.14-0 .99 ; P = 0.048 ) .


In patients undergoing elective PCI , preprocedure intravenous treatment with vitamin C is associated with less myocardial injury .


HIV infection has been associated with an increased risk of chronic kidney disease ( CKD ) .


Little is known about the prevalence of CKD in individuals with high CD4 cell counts prior to initiation of antiretroviral therapy ( ART ) .


We sought to address this knowledge gap .


We describe the prevalence of CKD among 4637 ART-nave adults ( mean age 36.8 years ) with CD4 cell counts > 500 cells/L at enrolment in the Strategic Timing of AntiRetroviral Treatment ( START ) study .


CKD was defined by estimated glomerular filtration rate ( eGFR ) < 60mL/min/1 .73 m ( 2 ) and/or dipstick urine protein 1 + .


Logistic regression was used to identify baseline characteristics associated with CKD .


Among 286 [ 6.2 % ; 95 % confidence interval ( CI ) 5.5 % , 6.9 % ] participants with CKD , the majority had isolated proteinuria .


A total of 268 participants had urine protein 1 + , including 41 with urine protein 2 + .


Only 22 participants ( 0.5 % ) had an estimated glomerular filtration rate < 60mL/min/1 .73 m ( 2 ) , including four who also had proteinuria .


Baseline characteristics independently associated with CKD included diabetes [ adjusted odds ratio ( aOR ) 1.73 ; 95 % CI 1.05 , 2.85 ] , hypertension ( aOR 1.82 ; 95 % CI 1.38 , 2.38 ) , and race/ethnicity ( aOR 0.59 ; 95 % CI 0.37 , 0.93 for Hispanic vs. white ) .


We observed a low prevalence of CKD associated with traditional CKD risk factors among ART-nave clinical trial participants with CD4 cell counts > 500 cells/L .


Most patients remain symptomatic after an initial intervention with approved treatments for generalized social anxiety disorder .


This randomized controlled trial provides systematic , prospectively derived data on the relative benefits of `` next-step '' pharmacotherapies to improve outcomes for individuals with generalized social anxiety disorder who remain symptomatic after initial treatment .


This three site , 12-week , double-blind randomized controlled trial compared the relative benefits of three strategies for patients remaining symptomatic ( Liebowitz Social Anxiety Scale [ LSAS ] score > 50 ) after a 10-week trial of sertraline alone : the addition of up to 3.0 mg/day of clonazepam ( sertraline plus clonazepam ) , a switch to up to 225 mg/day of venlafaxine , or prolonged sertraline treatment with placebo ( sertraline plus placebo ) .


A total of 397 participants received at least one dose of sertraline ; 181 nonresponders ( LSAS score > 50 ) at week 10 were randomly assigned to sertraline plus clonazepam , switch to venlafaxine , or sertraline plus placebo .


Overall , 21 % of patients achieved remission ( LSAS score 30 ) at the endpoint , and 27 % of patients assigned to sertraline plus clonazepam achieved remission compared with patients assigned to sertraline plus placebo ( 17 % ) or venlafaxine ( 19 % ) , but the differences did not reach significance .


Sertraline plus clonazepam was associated with a significantly greater drop in LSAS severity ( p = 0.020 ) and disability ( p = 0.0028 ) compared with sertraline plus placebo ; no significant differences were observed on these parameters between venlafaxine and either sertraline plus placebo or sertraline plus clonazepam .


In supplemental analysis , the overall response rate ( LSAS score 50 ) was 46 % , including a significantly greater proportion of patients in the sertraline plus clonazepam group ( 56 % ) compared with the sertraline plus placebo group responding ( 36 % ; p = 0.027 ) ; differences did not reach significance between venlafaxine and sertraline plus placebo or sertraline plus clonazepam .


The findings suggest that the clonazepam augmentation strategy provides relative benefits for sertraline nonresponders in social anxiety disorder .


To observe the effects of transcutaneous acupoint electrical stimulation ( TAES ) combined with general anesthesia ( acupuncture analgesia combined with general anesthesia ) on postoperative pain , nausea and vomiting and exhausted defecation symptoms in patients undergoing gynecological laparoscopic operation .


Sixty patients with gynecological laparoscopic operation were randomly divided into TAES group and control group , with 30 cases in each group .


Patients of the control group received simple general anesthesia and those of the TAES group were treated with general anesthesia and TAES of bilateral Zusanli ( ST 36 ) and Liangqiu ( ST 34 ) .


Visual Analogue Scale ( VAS ) was used for measuring the patients ' pain reaction at 8 h , 24 h and 72 h after surgery .


Symptoms of patients ' nausea and vomiting , post-operation exhaust and defecation time were recorded after operation .


The VAS scores at time-points of 8 h , 24 h and 72 h and nausea level in the TAES group were significantly lower than those of the control group ( P < 0.01 , P < 0.05 ) .


The vomiting severity of the TAES group was also relatively lower in comparison with the control group , but without significant difference between the two groups ( P > 0.05 ) .


The post-operation exhaust and defecation time of patients in the TAES group apparently appeared earlier than those of patients in the control group ( P < 0.01 ) .


TAES combined with general anesthesia is effective in reducing post-operative pain and nausea , and improving gastrointestinal function in patients undergoing laparoscopic operation .