This trial will test a clinical network-based intervention to improve uptake of guideline recommended care for men with high-risk prostate cancer .


In Phase I , a phased randomised cluster trial will test a multifaceted intervention that harnesses the NSW Agency for Clinical Innovation ( ACI ) Urology Clinical Network to increase evidence-based care for men with high-risk prostate cancer following surgery .


The intervention will be introduced in nine NSW hospitals over @ months using a stepped wedge design .


Outcome data ( referral to radiation oncology for discussion of adjuvant radiotherapy in line with guideline recommended care or referral to a clinical trial of adjuvant versus salvage radiotherapy ) will be collected through review of patient medical records .


In Phase II , mixed methods will be used to identify mechanisms of provider and organisational change .


Clinicians ' knowledge and attitudes will be assessed through surveys .


Process outcome measures will be assessed through document review .


Semi-structured interviews will be conducted to elucidate mechanisms of change .


The study will be one of the first randomised controlled trials to test the effectiveness of clinical networks to lead changes in clinical practice in hospitals treating patients with high-risk cancer .


It will additionally provide direction regarding implementation strategies that can be effectively employed to encourage widespread adoption of clinical practice guidelines .


To compare whole-body vibration ( WBV ) with traditional recovery protocols after a high-intensity training bout .


In a randomized crossover study , @ athletes performed @ @-s Wingate sprints before completing either an active recovery ( @ min of cycling and stretching ) or WBV for @ min in a series of exercises on a vibration platform .


Muscle hemodynamics ( assessed via near-infrared spectroscopy ) were measured before and during exercise and into the @-min recovery period .


Blood lactate concentration , vertical jump , quadriceps strength , flexibility , rating of perceived exertion ( RPE ) , muscle soreness , and performance during a single @-s Wingate test were assessed at baseline and @ and @ min postexercise .


A subset of participants ( n = @ ) completed a @rd identical trial ( @ wk later ) using a passive @-min recovery period ( sitting ) .


There were no clear effects between the recovery protocols for blood lactate concentration , quadriceps strength , jump height , flexibility , RPE , muscle soreness , or single Wingate performance across all measured recovery time points .


However , the WBV recovery protocol substantially increased the tissue-oxygenation index compared with the active ( @ % @ % -LSB- mean @ % CI -RSB- , effect size -LSB- ES -RSB- = @ , and -@ % @ % , ES = -@ for the @ min postexercise and postrecovery , respectively ) and passive recovery conditions ( @ % @ % , ES = @ , @ min postexercise only ) .


Although WBV during recovery increased muscle oxygenation , it had little effect in improving subsequent performance compared with a normal active recovery .


Epidural analgesia has been the preferred analgesic technique after major abdominal surgery .


On the other hand , the combined use of intrathecal morphine ( ITM ) and intravenous patient controlled analgesia ( IVPCA ) has been shown to be a viable alternative approach for analgesia .


We hypothesized that ITM combined with IVPCA is as effective as patient controlled thoracic epidural analgesia ( PCTEA ) with respect to postoperative pain control after conventional open gastrectomy .


Sixty-four patients undergoing conventional open gastrectomy due to gastric cancer were randomly allocated into the intrathecal morphine combined with intravenous patient-controlled analgesia ( IT ) group or patient-controlled thoracic epidural analgesia ( EP ) group .


The IT group received preoperative @ mg of ITM , followed by postoperative IVPCA .


The EP group preoperatively underwent epidural catheterization , followed by postoperative PCTEA .


Visual analog scale ( VAS ) scores were assessed until @ hrs after surgery .


Adverse effects related to analgesia , profiles associated with recovery from surgery , and postoperative complications within @ days after surgery were also evaluated .


This study failed to demonstrate the non-inferiority of ITM-IVPCA ( n = @ ) to PCTEA ( n = @ ) with respect to VAS @ hrs after surgery .


Furthermore , the IT group consumed more fentanyl than the EP group did ( @ g vs. @ g , p < @ ) .


The IT group took a longer time to ambulate than the EP group ( p = @ ) and had higher incidences of postoperative ileus ( p = @ ) and pulmonary complications ( p = @ ) compared with the EP group .


ITM-IVPCA is not as effective as PCTEA in patients undergoing gastrectomy , with respect to pain control , ambulation , postoperative ileus and pulmonary complications .


To assess the safety and tolerability of high-dose creatine , the feasibility of enrolling premanifest and @ % at-risk subjects in a prevention trial , and the potential of cognitive , imaging , and blood markers .


Sixty-four eligible consenting participants were randomly allocated ( @:@ ) to @ g twice daily of creatine monohydrate or placebo for a @-month double-blind phase followed by a @-month open-label extension .


Subjects included premanifest ( tested ) and at-risk ( not tested ) individuals without clinical symptoms or signs of Huntington disease ( HD ) .


Primary outcomes were safety and tolerability .


Exploratory endpoints included fine motor , visuospatial , and memory performance ; structural and diffusion MRI ; and selected blood markers .


Forty-seven HD carriers and @ non-HD controls were enrolled .


Fifteen discontinued treatment ( @ assigned to placebo ) ; all were followed for the entire study period .


Primary analysis was by intent to treat .


The most common adverse events were gastrointestinal .


Neuroimaging demonstrated treatment-related slowing of cortical and striatal atrophy at @ and @ months .


We describe a design that preserves the autonomy of subjects not wanting genetic testing while including controls for assessing the specificity of treatment effects .


Our results demonstrate the feasibility of prevention trials for HD and the safety of high-dose creatine , provide possible evidence of disease modification , support future studies of creatine , and illustrate the value of prodromal biomarkers .


This study provides Class I evidence that high-dose creatine is safe and tolerable .


This study examined the impact on college students ' perceptions of nonmedical use of prescription stimulants ( NMUPS ) of motivation for use and gender .


Participants were college students ( N = @ ) from @ universities in different regions of the United States .


Participants read a vignette describing a college student who used a prescription stimulant for a nonmedical purpose and rated their perception of that individual using a semantic differential .


A @ ( participant gender ) by @ ( gender of the individual described in the vignette ) by @ ( motive for use : get high , study , lose weight ) design was used .


The male who used a stimulant to study was rated significantly less negatively than if he used the stimulant to get high .


NMUPS as a study aid was viewed the least negatively overall .


Findings suggest that gender does not , whereas motivation for use does , impact students ' perceptions of NMUPS .


Semagacestat , a - secretase inhibitor , demonstrated an unfavorable risk-benefit profile in a Phase @ study of patients with Alzheimer 's disease ( IDENTITY trials ) , and clinical development was halted .


To assist in future development of - secretase inhibitors , we report detailed safety findings from the IDENTITY study , with emphasis on those that might be mechanistically linked to - secretase inhibition .


The IDENTITY trial was a double-blind , placebo-controlled trial of semagacestat ( @mg and @mg ) , in which @ patients age @ years and older with probable Alzheimer 's disease were randomized .


Treatment-emergent adverse events ( TEAEs ) are reported by body system along with pertinent laboratory , vital sign , and ECG findings .


Semagacestat treatment was associated with increased reporting of suspected Notch-related adverse events ( gastrointestinal , infection , and skin cancer related ) .


Other relevant safety findings associated with semagacestat treatment included cognitive and functional worsening , skin-related TEAEs , renal and hepatic changes , increased QT interval , and weight loss .


With few exceptions , differences between semagacestat and placebo treatment groups were no longer significant after cessation of treatment with active drug .


Many of these safety findings can be attributed to - secretase inhibition , and may be valuable to researchers developing - secretase inhibitors .


The purpose of this study was to determine whether a high-protein afternoon yogurt snack improves appetite control , satiety , and reduces subsequent food intake compared to other commonly-consumed , energy dense , high-fat snacks .


Twenty , healthy women ( age : @ y ; BMI : @ kg/m@ ) completed the randomized crossover design study which included @ , @-h testing days comparing the following @ kcal afternoon snacks : high-protein yogurt ( @ g protein/@ g CHO/@ g fat ) ; high-fat crackers ( @ g protein/@ g CHO/@ g fat ) ; and high-fat chocolate ( @ g protein/@ g CHO/@ g fat ) .


Participants were acclimated to each snack for @ consecutive days .


On day @ , the participants consumed a standardized breakfast and lunch ; the respective snack was consumed @-h post-lunch .


Perceived hunger and fullness were assessed throughout the afternoon until dinner was voluntarily requested .


An ad libitum dinner was then provided .


The consumption of the yogurt snack led to greater reductions in afternoon hunger vs. chocolate ( p < @ ) .


No differences in afternoon fullness were detected .


The yogurt snack also delayed eating initiation by approximately @ min compared to the chocolate snack ( p < @ ) and approximately @ min vs. crackers ( p = @ ) .


The yogurt snack led to approximately @ fewer kcals consumed at dinner vs. the crackers ( p = @ ) and chocolate ( p < @ ) .


No other differences were detected .


These data suggest that , when compared to high-fat snacks , eating less energy dense , high-protein snacks like yogurt improves appetite control , satiety , and reduces subsequent food intake in healthy women .


To study the effects of dopamine and phenylephrine for treatment of hypotension during cesarean section under combined spinal epidural anesthesia ( CSEA ) on the stereology of the placenta .


Forty puerperants undergoing cesarean section under CSEA were randomly divided into dopamine group and phenylephrine group .


Ropivacaine ( @ mg ) was administered immediately after spinal anethesia .


Blood pressure was maintained near the baseline by adjusting the drug infusion rate .


Fetal blood gas , Apgar score , and placental villus microvascular stereological changes were observed during the operation .


The microvascular density was significantly lower in dopamine group than in phenylephrine group ( P < @ ) .


Phenylephrine group showed significantly lower umbilical artery blood pH than dopamine group ( P < @ ) .


The Apgar score and blood pressure were comparable between the two groups ( P > @ ) .


Compared to the baseline , both of the two groups showed significantly lowered heart rate during the operation ( P < @ ) .


Dopamine is associated with the risk of fetal acidosis .


Phenylephrine is helpful for preventing hypotension by increasing placental blood flow and improving oxygen supply to ensure maternal and fetal safety during cesarean section .


In patients with Alzheimer 's disease ( AD ) , the relationship between cognitive and functional progression is not fully understood ; however , functional decline has been postulated to follow cognitive decline .


To assess the relationship between cognitive and functional treatment effects in mild AD dementia patients .


Data of patients with mild AD were pooled from two multicenter , double-blind , Phase @ studies .


Patients were randomized to infusions of @-mg solanezumab ( n = @ ) , or placebo ( n = @ ) every @ weeks for @ months .


Cognitive and functional outcome measures were assessed using the AD Assessment Scale-Cognitive subscale ( ADAS-Cog ) and the AD Cooperative Study-Activities of Daily Living ( ADCS-ADL ) , respectively .


Analyses included comparisons among normalized scales , correlations between outcome measures , and path analyses to model the relationship of treatment effect on cognition and function .


Normalized ADAS-Cog and ADCS-ADL scales showed cognitive impairment was more evident than functional impairment in mild AD .


The correlation between cognition and function increased over time .


Path analyses demonstrated that @ % of the treatment effect on function was driven by the treatment effect on cognition , with the remaining @ % due to direct treatment effect .


Findings from this study are consistent with the hypothesis that functional impairment is primarily driven by and follows cognitive decline in mild AD dementia .


The cognitive treatment effect appeared to explain the majority of the functional treatment effect .


It is possible that a cognitive treatment effect may be considered as a leading indicator for functional outcomes in an @-month clinical trial for milder stages of AD .


To determine whether response to a dietary intervention is greater among people with family history of colorectal cancer ( CRC ) compared with a general population .


Cohort study examining participants from @ related studies .


Rural Virginia .


Seventy people with first-degree relatives with CRC and @ participants from the intervention arm of a trial in the general population .


Both studies implemented a low-intensity intervention delivered via telephone and mail , including low-literacy self-help booklets and personalized dietary feedback .


Fat , fiber , and fruit and vegetable behavior .


Propensity score matching controlled for confounders .


Mixed-model ANOVAs compared samples ; mediation by perceived cancer risk was assessed .


Participants in both groups significantly improved fat , fiber , and fruit and vegetable behavior at @-month follow-up ; there was significantly greater improvement in the general population sample .


Cancer risk perception did not mediate the relationship between study sample and dietary change .


Contrary to expectations , first-degree relatives of CRC patients did not respond better to a dietary intervention than the general population , nor was risk perception related to dietary change .


Given the role of diet in CRC risk , additional research should investigate targeted strategies to improve dietary intakes of people at higher cancer risk .


To compare changes in vitamin D status and cathelicidin ( LL-@ ) levels in septic ICU patients treated with placebo versus cholecalciferol .


Randomized , placebo-controlled , trial .


Medical and surgical ICUs of a single teaching hospital in Boston , MA .


Thirty adult ICU patients .


Placebo ( n = @ ) versus @,@ IU cholecalciferol ( n = @ ) versus @,@ IU cholecalciferol ( n = @ ) , within @ hours of new-onset severe sepsis or septic shock .


Blood samples were obtained at baseline ( day @ ) and on days @ , @ , and @ , to assess total @-hydroxyvitamin D , as well as vitamin D-binding protein and albumin to calculate bioavailable @-hydroxyvitamin D. Plasma LL-@ and high-sensitivity C-reactive protein levels were also measured .


At baseline , median ( interquartile range ) plasma @-hydroxyvitamin D was @ng/mL ( @-@ng / mL ) and peaked by day @ in both intervention groups .


Groups were compared using Kruskal-Wallis tests .


Relative to baseline , on day @ , median change in biomarkers for placebo , @,@ IU cholecalciferol , and @,@ IU cholecalciferol groups , respectively , were as follows : @ ) total @-hydroxyvitamin D , @ % ( -@ % to @ % ) , @ % ( @-@ % ) , and @ % ( @-@ % ) ( p < @ ) ; @ ) bioavailable @-hydroxyvitamin D , @ % ( -@ % to @ % ) , @ % ( @-@ % ) , and @ % ( @-@ % ) ( p < @ ) ; and @ ) LL-@ : -@ % ( -@ % to -@ % ) , @ % ( -@ % to @ % ) , and @ % ( @-@ % ) ( p = @ ) .


Change in high-sensitivity C-reactive protein levels did not differ between groups .


A positive correlation was observed between bioavailable @-hydroxyvitamin D and LL-@ ( Spearman = @ ; p = @ ) but not for total @-hydroxyvitamin D and LL-@ .


High-dose cholecalciferol supplementation rapidly and safely improves @-hydroxyvitamin D and bioavailable @-hydroxyvitamin D levels in patients with severe sepsis or septic shock .


Changes in bioavailable @-hydroxyvitamin D are associated with concomitant increases in circulating LL-@ levels .


Larger trials are needed to verify these findings and to assess whether optimizing vitamin D status improves sepsis-related clinical outcomes .


Conflicting data exist regarding the association between left ventricular ( LV ) lead position and benefit from cardiac resynchronization therapy .


We evaluated the relationships between LV lead positions and the risk of death or hospitalization for heart failure ( HF ) in the cardiac resynchronization therapy arm of the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial ( RAFT ) .


LV lead position was categorized by site investigator ( MD ) and in a chest radiograph core laboratory ( CXR ) as `` anterior , '' `` lateral , '' or `` posterior '' in the short axis , and `` basal , '' `` mid , '' or `` apical '' in the long axis .


Agreement between MD and CXR LV lead position classification was evaluated and the independent relationship between LV lead position and clinical outcome was assessed using Cox multivariable models .


Agreement between MD and CXR LV lead position was poor ( @ ) .


Over @ @ months , @ of @ ( @ % ) patients met the RAFT primary end point ( death or HF hospitalization ) .


In adjusted analyses , neither MD-determined nor CXR-determined anterior or apical LV lead position was significantly associated with the primary outcome .


However , CXR-defined apical LV lead position was associated with a higher risk of HF hospitalization ( hazard ratio , @ ; P = @ ) .


Poor agreement between implanting physician and core lab CXR-based categorizations of LV lead position was observed .


Neither categorization method resulted in significant associations between apical or anterior LV lead position and the risk of the composite primary outcome of death or heart failure hospitalization .


However , CXR-defined apical lead position was associated with increased risk of HF hospitalization .


This article presents the results of a multiuser , randomized laboratory trial comparing the accuracy and precision of image-based navigation against individualized guides for distal radius osteotomy ( DRO ) .


Six surgeons each performed four DROs using image-based navigation and four DROs using individualized guides in a laboratory setting with plastic phantom replicas of radii from patients who had received DRO as treatment for radial deformity .


Time required and correction errors of ulnar variance , radial inclination , and volar tilt were measured .


There were no statistically significant differences in the average correction errors .


There was a statistically significant difference in the standard deviation of ulnar variance error ( @ mm for navigation vs. @ mm for guides ) .


There was a statistically significant difference in the standard deviation of radial inclination error ( -LSB- Formula : see text -RSB- for navigation vs. -LSB- Formula : see text -RSB- for guides ) .


There were statistically significant differences in the times required ( @ s for navigation vs. @ s for guides ) and their standard deviations ( @ s for navigation vs. @ s for guides ) .


Compared to navigated DRO , individualized guides were easier to use , faster , and produced more precise correction of ulnar variance and radial inclination .


The combination of true three-dimensional planning , ease of use , and accurate and precise corrective guidance makes the individualized guide technique a promising approach for performing corrective osteotomy of the distal radius .


To assess the efficacy and short-term safety of levodopa as adjunctive treatment to patching for amblyopia .


Randomized , placebo-controlled trial .


One hundred thirty-nine children @ to @ years of age with residual amblyopia resulting from strabismus , anisometropia , or both combined ( visual acuity -LSB- VA -RSB- , @/@-@ / @ ) after patching .


Sixteen weeks of oral levodopa or placebo administered @ times daily while patching the fellow eye @ hours daily .


Mean change in best-corrected amblyopic-eye VA at @ weeks .


At @ weeks , amblyopic-eye VA improved from randomization by an average of @ letters in the levodopa group and by @ letters in the placebo group ( difference adjusted for baseline VA , +@ letters ; @-sided P = @ ; @-sided @ % confidence interval , -@ to @ letters ) .


No serious adverse effects from levodopa were reported during treatment .


For children @ to @ years of age with residual amblyopia after patching therapy , oral levodopa while continuing to patch @ hours daily does not produce a clinically or statistically meaningful improvement in VA compared with placebo and patching .


Teriflunomide is an oral disease-modifying therapy approved for treatment of relapsing or relapsing-remitting multiple sclerosis .


We aimed to provide further evidence for the safety and efficacy of teriflunomide in patients with relapsing multiple sclerosis .


This international , randomised , double-blind , placebo-controlled , phase @ study enrolled adults aged @-@ years with relapsing multiple sclerosis , one or more relapse in the previous @ months or two or more in the previous @ months but no relapse in the previous @ days , and an Expanded Disability Status Scale ( EDSS ) score of @ points or less .


Patients were recruited from @ sites in @ countries and randomly assigned ( @:@:@ ) to once-daily placebo , teriflunomide @ mg , or teriflunomide @ mg via an interactive voice recognition system .


Treatment duration was variable , ending @ weeks after the last patient was included .


The primary endpoint was annualised relapse rate ( number of relapses per patient-year ) and the key secondary endpoint was time to sustained accumulation of disability ( an EDSS score increase of at least @ EDSS point sustained for a minimum of @ weeks ) , both analysed in the modified intention-to-treat population ( all patients who received at least one dose of assigned study medication ) .


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


Between Sept @ , @ , and Feb @ , @ , @ patients were randomly assigned to a treatment group , of whom @ , @ , and @ patients received at least one dose of placebo , teriflunomide @ mg , or teriflunomide @ mg , respectively .


By the end of the study , the annualised relapse rate was higher in patients assigned to placebo ( @ -LSB- @ % CI @-@ @ -RSB- ) than in those assigned to teriflunomide @ mg ( @ -LSB- @-@ @ -RSB- ; p = @ ) or teriflunomide @ mg ( @ -LSB- @-@ @ -RSB- ; p = @ ) .


Compared with placebo , teriflunomide @ mg reduced the risk of sustained accumulation of disability ( hazard ratio -LSB- HR -RSB- @ -LSB- @ % CI @-@ @ -RSB- ; log-rank p = @ ) ; however , teriflunomide @ mg had no effect on sustained accumulation of disability ( HR @ -LSB- @-@ @ -RSB- ; log-rank p = @ ) .


The most common adverse events were alanine aminotransferase increases ( @ -LSB- @ % -RSB- of @ patients in the placebo group vs @ -LSB- @ % -RSB- of @ patients in the teriflunomide @ mg group vs @ -LSB- @ % -RSB- of @ patients in the teriflunomide @ mg group ) , hair thinning ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , and headache ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


Incidence of serious adverse events was similar in all treatment groups ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


Four deaths occurred , none of which was considered to be related to study drug ( respiratory infection in the placebo group , traffic accident in the teriflunomide @ mg group , and suicide and septicaemia due to Gram-negative infection complicated by disseminated intravascular coagulopathy in the teriflunomide @ mg group ) .


Teriflunomide @ mg was associated with a lower relapse rate and less disability accumulation compared with placebo , with a similar safety and tolerability profile to that reported in previous studies .


These results confirm the dose effect reported in previous trials and support the use of teriflunomide @ mg in patients with relapsing multiple sclerosis .


To determine whether hysterosalpingo-foam sonography ( HyFoSy ) is a less painful first line tubal patency test than serial hysterosalpingography ( HSG ) .


A two-center , prospective , open-label , randomized , controlled trial .


University hospital and teaching hospital .


@ subfertile women , ages @ to @years , with an indication for tubal patency testing as part of the fertility workup according to the Dutch Nederlandse Vereniging voor Obsteterie & Gynaecologie-guidelines .


Tubal patency testing by HyFoSy versus serial HSG .


Visual Analogue Scale ( VAS ) pain scores during tubal patency testing .


The median VAS score for pain perception during the HyFoSy procedure was @ cm ( interquartile range : @ ) compared with @ cm ( interquartile range : @ ) during HSG .


The HyFoSy procedure also had a statistically significantly shorter procedure time compared with HSG , with a median of @ minutes ( interquartile range : @ ) for HyFoSy versus @ minutes ( interquartile range : @ ) for HSG .


The HyFoSy procedure is a less painful and less time-consuming tubal patency test compared with HSG .


Few pharmacotherapies have demonstrated sufficient efficacy in the treatment of posttraumatic stress disorder ( PTSD ) , a chronic and disabling condition .


To test the efficacy and safety of a single intravenous subanesthetic dose of ketamine for the treatment of PTSD and associated depressive symptoms in patients with chronic PTSD .


Proof-of-concept , randomized , double-blind , crossover trial comparing ketamine with an active placebo control , midazolam , conducted at a single site ( Icahn School of Medicine at Mount Sinai , New York , New York ) .


Forty-one patients with chronic PTSD related to a range of trauma exposures were recruited via advertisements .


Intravenous infusion of ketamine hydrochloride ( @ mg/kg ) and midazolam ( @ mg/kg ) .


The primary outcome measure was change in PTSD symptom severity , measured using the Impact of Event Scale-Revised .


Secondary outcome measures included the Montgomery-Asberg Depression Rating Scale , the Clinical Global Impression-Severity and - Improvement scales , and adverse effect measures , including the Clinician-Administered Dissociative States Scale , the Brief Psychiatric Rating Scale , and the Young Mania Rating Scale .


Ketamine infusion was associated with significant and rapid reduction in PTSD symptom severity , compared with midazolam , when assessed @ hours after infusion ( mean difference in Impact of Event Scale-Revised score , @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) .


Greater reduction of PTSD symptoms following treatment with ketamine was evident in both crossover and first-period analyses , and remained significant after adjusting for baseline and @-hour depressive symptom severity .


Ketamine was also associated with reduction in comorbid depressive symptoms and with improvement in overall clinical presentation .


Ketamine was generally well tolerated without clinically significant persistent dissociative symptoms .


This study provides the first evidence for rapid reduction in symptom severity following ketamine infusion in patients with chronic PTSD .


If replicated , these findings may lead to novel approaches to the pharmacologic treatment of patients with this disabling condition .


There is limited information about the effects of beta-blockers in heart failure ( HF ) stratified by blood pressure , especially in the elderly and those with preserved EF .


We evaluate the effects of nebivolol on outcomes in elderly patients with HF stratified by baseline systolic blood pressure ( SBP ) and EF .


The SENIORS trial evaluated the effects of nebivolol and enrolled @ patients @ years of age with HF .


Patients were divided into three baseline pre-treatment SBP categories ( < @ , @-@ , and > @ mmHg ) .


In addition , we evaluated the influence of SBP ( @ and > @ mmHg ) on patients with LVEF < @ % vs. @ % .


Low baseline SBP was associated with worse clinical outcomes irrespective of treatment group , both in patients with reduced EF and in those with preserved EF .


Nebivolol had similar benefits irrespective of baseline SBP : the hazard ratio ( HR ) for primary outcome of all-cause mortality or cardiovascular hospitalization in the three SBP categories for nebivolol vs. placebo was @ -LSB- @ % confidence interval ( CI ) @-@ @ -RSB- , @ ( @ % CI @-@ @ ) , and @ ( @ % CI @-@ @ ) , respectively ( P for interaction = @ ) .


Similar results were obtained for the secondary endpoint of all-cause mortality .


There was no significant interaction for the effects of nebivolol by baseline SBP stratified by LVEF .


Elderly HF patients with lower SBP have a worse outcome than those with higher SBP , but nebivolol appears to be safe and well tolerated , with similar benefits on the composite outcome of death or cardiovascular hospital admission irrespective of baseline SBP and LVEF .


MK-@ is an inhibitor of the hepatitis C virus ( HCV ) nonstructural protein @/@A protease ; MK-@ is taken once daily and has a higher potency and barrier to resistance than licensed protease inhibitors .


We investigated the efficacy and tolerability of MK-@ with peginterferon and ribavirin ( PR ) in treatment-naive patients with chronic HCV genotype @ infection without cirrhosis .


We performed a multicenter , double-blind , randomized , active-controlled , dose-ranging , response-guided therapy study .


A total of @ patients received MK-@ ( @ , @ , @ , or @ mg ) once daily for @ weeks in combination with PR .


Patients in the MK-@ groups received PR for an additional @ or @ weeks , based on response at week @ .


Patients in the control group ( n = @ ) received a combination of boceprevir and PR , dosed in accordance with boceprevir 's US product circular .


At @ weeks after the end of therapy , sustained virologic responses were achieved in @ % , @ % , @ % , and @ % of the patients in the groups given the combination of PR and MK-@ ( @ , @ , @ , or @ mg ) , respectively , vs @ % of controls .


In the MK-@ group receiving @ mg , @ % of patients had undetectable levels of HCV RNA at week @ and qualified for the short duration of therapy .


The combination of MK-@ and PR generally was well tolerated .


Transient increases in transaminase levels were noted in the MK-@ groups given @ and @ mg , at higher frequencies than in the MK-@ groups given @ or @ mg , or control groups .


Once-daily MK-@ ( @ mg ) with PR for @ or @ weeks was highly effective and well tolerated among treatment-naive patients with HCV genotype @ infection without cirrhosis .


Studies are underway to evaluate interferon-free MK-@-based regimens .


ClinicalTrials.gov number : NCT@ .


This @-month study , conducted in The Netherlands , examined the feasibility of enhancing the effectiveness of assertive community treatment ( ACT ) by adding evidence-based interventions .


A total of @ patients were randomly assigned to two ACT teams , one providing standard ACT ( N@ ) and an ACT Plus team that also provided evidence-based interventions ( N@ ) : psychoeducation , family interventions , individual placement and support , and cognitive behavioral therapy .


The interventions were conducted by psychologists and nurse practitioners working independently from the ACT team .


Although most patients were judged eligible for each of the four interventions ( range @ % to @ % ) , only @ of the @ patients ( @ % ) successfully completed an intervention .


Outcomes , such as use of inpatient care , for ACT Plus and standard ACT patients did not differ significantly .


Guidelines for the treatment of schizophrenia should consider the feasibility of delivering evidence-based interventions to difficult-to-engage patients .


Despite an increase in overweight and obesity similar to the civilian population , there have been few randomized controlled trials examining behavioral weight management interventions in the military settings .


This paper describes the design , intervention development and analysis plan of the Fit Blue study , a randomized controlled behavioral weight loss trial taking place in the United States Air Force .


This study compares two adapted versions of the efficacious Look AHEAD Intensive Lifestyle Intervention ( ILI ) , a counselor-initiated condition and a self-paced condition .


Also described are the unique steps required when conducting military-based health promotion research and adaptations made to the Look AHEAD intervention to accommodate the military environment .


To our knowledge , this is the first translation of the Look AHEAD ILI in the military setting and one of the first translations of the ILI in general .


If successful , this intervention could be disseminated to the entire U.S. Military as this project is designed to overcome the barriers and utilize the facilitators for weight loss that are unique to a military population .


Programs validated in military populations can have a major public health impact given that with @ million active duty personnel , the Department of Defense is the nation 's largest employer .


However , while this intervention is designed for a military population and there are unique aspects of the military that may enhance weight loss interventions , the diversity of the study population should help inform obesity efforts in both civilian and military settings .


Long-acting , injectable , second-generation antipsychotic medication has tremendous potential to bring clinical stability to persons with schizophrenia .


However , long-acting medications are rarely used following a first episode of schizophrenia .


To compare the clinical efficacy of the long-acting injectable formulation of risperidone with the oral formulation in the early course of schizophrenia .


A randomized clinical trial performed at a university-based research clinic , between @ and @ .


Eighty-six patients with recent onset of schizophrenia were randomized to receive long-acting injectable risperidone or oral risperidone .


Half of each group was simultaneously randomized to receive cognitive remediation to improve cognitive functioning or healthy-behaviors training to improve lifestyle habits and well-being .


An intent-to-treat analysis was performed between October @ , @ , and November @ , @ .


A @-month trial comparing the long-acting injectable vs oral risperidone and cognitive remediation vs healthy-behaviors training .


Psychotic relapse and control of breakthrough psychotic symptoms .


Of the @ patients randomized , @ refused treatment in the long-acting injectable risperidone group .


The psychotic exacerbation and/or relapse rate was lower for the long-acting risperidone group compared with the oral group ( @ % vs @ % ; @ = @ ; P < @ ; relative risk reduction ,@ % ) .


Long-acting injectable risperidone better controlled mean levels of hallucinations and delusions throughout follow-up ( = -@ ; t@ = -@ , P = @ ) .


The cognitive remediation and healthy-behaviors training groups did not differ significantly regarding psychotic relapse , psychotic symptom control , or hospitalization rates , and there were no significant interactions between the @ medications and the @ psychosocial treatments .


Discontinuations owing to inadequate clinical response were more common in the oral group than in the long-acting risperidone group ( @ = @ ; P = @ ) .


Adherence to oral risperidone did not appear to differ before randomization but was better for the long-acting risperidone group compared with the oral group ( t@ = @ ; P < @ ) .


Medication adherence was associated with prevention of exacerbation and/or relapse ( @ = @ ; P = @ ) and control of breakthrough psychotic symptoms ( = @ ; t@ = @ ; P = @ ) .


The use of long-acting injectable risperidone after a first episode of schizophrenia has notable advantages for clinical outcomes .


The key clinical advantages are apparently owing to the more consistent administration of the long-acting injectable .


Such formulations should be offered earlier in the course of illness .


Studies in HIV-@-infected infants and HIV-@-exposed , uninfected infants link early cytomegalovirus ( CMV ) acquisition with growth delay and cognitive impairment .


We investigated maternal valacyclovir to delay infant acquisition of CMV .


Pregnant women with HIV-@ , HSV-@ and CD@ count > @ cells/l were randomized at @ weeks gestation to @ mg twice-daily valacyclovir or placebo for @ months .


Maternal CMV DNA was measured in plasma at @ weeks gestation , in cervical secretions at @ and @ weeks gestation , and in breast milk at @ postpartum timepoints ; infant CMV DNA was measured in dried blood spots at @ timepoints including birth .


Among @ women , @ infants were compared in intent-to-treat analyses .


Maternal and infant characteristics were similar between study arms .


Infant CMV acquisition did not differ between study arms , with @/@ infants ( @ % ) in placebo arm and @/@ infants ( @ % ) in the valacyclovir arm acquiring CMV ; median time to CMV detection did not differ .


CMV DNA was detected in @ % of @ breast milk specimens with no difference in CMV level between study arms .


Change in cervical shedding of CMV DNA between baseline and @ weeks was @-log greater in the placebo arm than the valacyclovir arm ( p = @ ) .


In this cohort of HIV-@-seropositive mothers , two-thirds of infants acquired CMV by one year .


Maternal valacyclovir had no effect on timing of infant CMV acquisition or breast milk CMV viral loads , although it modestly reduced cervical CMV shedding .


Maternal prophylaxis to reduce infant CMV acquisition warrants further evaluation in trials with antiviral agents .


The Southeastern United States has the lowest kidney transplant rates in the nation , and racial disparities in kidney transplant access are concentrated in this region .


The Southeastern Kidney Transplant Coalition ( SEKTC ) of Georgia , North Carolina , and South Carolina is an academic and community partnership that was formed with the mission to improve access to kidney transplantation and reduce disparities among African American ( AA ) end stage renal disease ( ESRD ) patients in the Southeastern United States .


We describe the community-based participatory research ( CBPR ) process utilized in planning the Reducing Disparities In Access to kidNey Transplantation ( RaDIANT ) Community Study , a trial developed by the SEKTC to reduce health disparities in access to kidney transplantation among AA ESRD patients in Georgia , the state with the lowest kidney transplant rates in the nation .


The SEKTC Coalition conducted a needs assessment of the ESRD population in the Southeast and used results to develop a multicomponent , dialysis facility-randomized , quality improvement intervention to improve transplant access among dialysis facilities in GA. .


A total of @ dialysis facilities are randomized to receive either : ( @ ) standard of care or `` usual '' transplant education , or ( @ ) the multicomponent intervention consisting of transplant education and engagement activities targeting dialysis facility leadership , staff , and patients within dialysis facilities .


The primary outcome is change in facility-level referral for kidney transplantation from baseline to @months ; the secondary outcome is reduction in racial disparity in transplant referral .


The RaDIANT Community Study aims to improve equity in access to kidney transplantation for ESRD patients in the Southeast .


Atrial fibrillation ( AF ) is the most common arrhythmia .


NT-proBNP is a fragment of the prohormone brain natriuretic peptide .


Previous studies indicate that increased levels of NT-proBNP are associated with higher recurrence rates of AF after electrical cardioversion .


Our null hypothesis was that NT-proBNP does not predict recurrence of AF after restoration of sinus rhythm .


We performed a hypothesis generating study within a double-blinded , placebo-controlled , randomized , prospective multicentre study of the effects of atorvastatin on recurrence of AF after electrical cardioversion .


@ patients with persistent AF and an indication for cardioversion were included in the present substudy .


NT-proBNP was assessed prior to cardioversion .


Cardioversion was performed according to local standard clinical practice on an elective outpatient basis .


Patients were followed-up one month after cardioversion .


@ patients had a successful cardioversion and @ of the study group remained in sinus rhythm at day @ .


Recurrence of AF was observed in @ patients at day @ .


An optimal cutpoint for NT-proBNP at @ ng/L predicted recurrence of AF after cardioversion ( OR @ ; @ % CI @-@ @ ) .


In multivariate analysis adjusting for age , sex , hypertension , and treatment group strengthened the results ( OR @,@ ; @ % CI @,@-@ ,@ ) .


When analysing the ROC curve of NT-proBNP in baseline and atrial fibrillation at day @ the result was @ .


NT-proBNP levels are a predictor of recurrence of AF @ days after cardioversion .


ROC curves indicates that the practical value of NT-proBNP for the individual patient is limited .


The aim of this study was to evaluate the validity of a new apathy rating scale in predicting the ability to return to work ( RTW ) in patients with depression or anxiety a year after discharge from a psychiatric hospital .


We evaluated @ patients with depression or anxiety , who participated in an on-going randomised clinical trial using RTW as primary outcome .


The degree of apathy was measured by the Diagnostic Apathia Scale , which contains six items covering the following neuropsychological symptoms : concentration/memory problems , difficulties in decision making , lassitude , tiredness/fatigue , insomnia , and reduced ability to work and engage in personal interests .


The scale was analysed for psychometric validity ( scalability ) and for its ability to predict RTW .


Finally , the predictive validity of the Diagnostic Apathia Scale regarding RTW was compared with scales measuring severity of depression/anxiety symptoms , disability , and psychological well-being .


The Diagnostic Apathia Scale displayed sufficient scalability , that is , the total score was a psychometrically valid measure of apathy .


Only the Diagnostic Apathia Scale , and not the scales measuring severity of symptoms , disability , or psychological well-being , had predictive validity regarding RTW .


Thus , @ % with ` clinically significant apathy ' at baseline were unable to RTW versus @ % of the patients without apathy ( p < @ ) .


The Diagnostic Apathia Scale was found to have an acceptable predictive validity in terms of patients ' ability to RTW @ year after discharge from hospitalisation for depression or anxiety .


To compare differences of therapeutic effect between acupuncture method of tonifying-qi and dredging-meridian and conventional acupuncture method .


Seventy cases of blepharospasm were randomly divided into an observation group and a control group , @ cases in each one .


Cuanzhu ( BL @ ) , Yuwei ( Extra ) through Yuyao ( EX-HN @ ) , Xinming @ ( Extra ) , Sibai ( ST @ ) and Yintang ( GV @ ) were selected as main acupoints .


The acupuncture method of tonifying-qi and dredging-meridian was applied in the observation group , which was an acupuncture manipulation that could achieve strong needling sensation of qi arrival combined with electric-impulse stimulation .


The conventional acupuncture method was applied in the control group .


The treatment was given once every other day , @ times as a session for continuous three sessions in both groups .


The severity of blepharospasm was compared before and after treatment in two groups and clinical therapeutic effect was assessed .


Follow-up visit was performed after half a year to observe the recurrence rate .


The cured and markedly effective rate was @ % ( @/@ ) in the observation group , which was superior to @ % ( @/@ ) in the control group ( P < @ ) .


Among cured and markedly effective patients in both groups , the recurrence rate was @ % ( @/@ ) in the observation group , which was inferior to @ % ( @/@ ) in the control group ( P < @ ) in the follow-up visit .


The acupuncture method of tonifying-qi and dredging-meridian could effectively improve severity of blepharospasm , which has superior short-term and long-term effects to conventional acupuncture method .


Airway narrowing is maintained for a prolonged period after acute bronchoconstriction in humans in the absence of deep inspirations ( DIs ) .


To determine whether maintenance of airway smooth muscle ( ASM ) shortening is responsible for the persistence of airway narrowing in healthy subjects following transient methacholine ( MCh ) - induced bronchoconstriction .


On two separate visits , five healthy subjects underwent MCh challenges until respiratory system resistance ( Rrs ) had increased by approximately @ cm H@O/L/s .


Subjects took a DI either immediately after or @ minutes after the last dose .


The extent of renarrowing following the bronchodilator effect of DI was used to assess the continued action of MCh ( calculated as percent change in Rrs from the pre-DI Rrs ) .


We then used human bronchial rings to determine whether ASM can maintain shortening during a progressive decrease of carbachol concentration .


The increased Rrs induced by MCh was maintained for @ minutes despite waning of MCh concentration over that period , measured as attenuated renarrowing when the DI was taken @ minutes after compared with immediately after the last dose ( @ min post-DI , -@ @ vs. @ @ % ; @ min post-DI , -@ @ vs. @ @ % ) .


Ex vivo , ASM shortening was largely maintained during a progressive decrease of carbachol concentration , even down to concentrations that would not be expected to induce shortening .


The maintenance of airway narrowing despite MCh clearance in humans is attributed to an intrinsic ability of ASM to maintain shortening during a progressive decrease of contractile stimulation .


To assess the effect of mitomycin-C ( MMC ) on the tear film , corneal biomechanics , and surface irregularity in surface ablation ( photorefractive keratectomy -LSB- PRK -RSB- ) for low to moderate myopia .


Refractive Surgery Unit , Farabi Eye Hospital , Tehran , Iran .


Double-masked randomized clinical trial .


In patients with spherical equivalent myopia of -@ to -@ diopters ( D ) and astigmatism up to -@ D , the first eye was randomly assigned to the application of MMC @ % or a balanced salt solution for @ seconds .


The fellow eye received the alternate in a masked fashion after excimer photoablation .


The study enrolled @ patients .


In fellow eyes , the changes in the tear-film index were comparable @ month and @ months postoperatively .


There was no significant difference in changes in total higher-order aberrations , spherical aberration , coma , or Q values ( Pentacam HR ) between fellow eyes at @ month and @ months .


There was a trend toward a higher asymmetry index at @ month ; however , a statistically significant drop was observed at @ months in the MMC group ( P < @ ) .


It was hypothesized that stromal remodeling was delayed , but better , in MMC-treated eyes .


No haze was recorded at @ months in either group .


Use of MMC in PRK did not appear to contribute significantly to surface irregularity , transient tear-film dysfunction , or biomechanical weakening of the cornea compared with PRK without MMC .


Self-instruction video ( SIV ) has been widely explored as a teaching mode for cardiopulmonary resuscitation ( CPR ) and automated external defibrillation ( AED ) , but not with other basic emergency skills .


To evaluate the effectiveness of SIV in teaching other basic emergency skill in comparison with traditional face-to-face ( FTF ) methods .


Participants were randomized into SIV and FTF groups .


Each group was assigned to learn basic airway management ( BAM ) , cervical collar application ( CCA ) , manual cardiac defibrillation ( MCD ) , and emergency extremity splinting ( EES ) skills .


Confidence level was assessed using questionnaires , and skills performances were assessed using calibrated-blinded assessors through an Objective Structured Clinical Examination ( OSCE ) .


Forty-five participants took part in the assessment exercises .


There were no significant differences between both groups , on all four skill categories .


The mean OSCE-score of an individual category between the FTF-group vs. the SIV-group were as follows : BAM ( @ vs. @ ; p = @ ) ; CCA ( @ vs. @ ; p = @ ) ; MCD ( @ vs. @ ; p = @ ) ; EES ( @ vs. @ ; p = @ ) .


The composite mean score for the FTF-group was @ , and for the SIV-group was @ ( p < @ ) .


There was no significant different in the level of confidence for both groups .


SIV is as effective as FTF in teaching and learning basic emergency skills .


Blood collection through intravenous lines frequently causes spurious hemolysis .


Due to specific structure , the tube holder Holdex ( Greiner Bio-One GmbH , Kremsmuenster , Austria ) is supposed to prevent erythrocyte injury in samples collected from catheters , so that we planned a specific study to support this hypothesis .


Blood was collected from emergency department ( ED ) patients with @-gauge catheter .


In patients with odd order numbers , first and second tubes were collected with conventional holder ( BD Vacutainer One Use Holder , Becton Dickinson , Milan , Italy ) and the third with Holdex , whereas in even patients first and second tubes were drawn with Holdex and the third using BD Vacutainer One Use Holder .


The first tube was discarded , whereas the second and third were centrifuged and serum was tested for potassium , lactate dehydrogenase ( LD ) and hemolysis index .


The final study population consisted in @ ED patients .


Concentrations of potassium ( @ vs. @ mmol/L ; P = @ ) , LD ( @ vs. @ U/L ; P = @ ) and cell-free hemoglobin ( @ vs. @ g/L ; P = @ ) were higher in samples collected with BD Vacutainer One Use Holder than with Holdex .


The mean bias of cell-free hemoglobin was -@ g/L in samples collected with Holdex .


Although the frequency of samples with cell-free hemoglobin > @ g/L was identical ( @/@ vs. @/@ ; P = @ ) , the frequency of those with concentrations > @ g/L was higher using BD Vacutainer One Use Holder than Holdex ( @/@ vs. @/@ ; P = @ ) .


The use of Holdex for drawing blood from intravenous lines may be effective for reducing gross hemolysis .


To prospectively compare norfloxacin ( N ) with trimethoprim-sulfamethoxazole ( T-S ) in preventing infection in cirrhotic patients .


Cirrhotic patients at high risk of spontaneous bacterial peritonitis ( SBP ) were recruited and assigned N ( @mg daily ) or T-S ( @/@mg daily ) .


Patients were followed up for @ months .


The primary end-point was the incidence of infection .


Secondary end-points included the incidence of SBP , bacteremia , extraperitoneal infection requiring antibiotic treatment , liver transplantation , death , side effects and rate of resistance to N or T-S .


A total of @ patients with a mean age of @ years were prescribed N ( n = @ ) or T-S ( n = @ ) .


Child-Pugh status , model for end-stage liver disease and risk factors for SBP were similar between the groups .


There were @ episodes of infections in the N group and @ in the T-S group ( P = @ ) .


Two patients each in the N and T-S group developed SBP ( P = @ ) .


There was a difference in the rate of transplantation favoring N ( P = @ ) but not death .


The number of adverse events for N ( n = @ ) and T-S ( n = @ ) were similar ( P = @ ) , with T-S being associated with an increased risk of developing a definite or probable adverse event compared to N ( @ % vs @ % , P = @ ) .


This study failed to demonstrate a difference between N and T-S groups in their effects on preventing infection in patients with liver cirrhosis .


T-S can be considered an alternative first-line therapy for infection prophylaxis .


Anonymous survey methods appear to promote greater disclosure of sensitive or stigmatizing information compared to non-anonymous methods .


Higher disclosure rates have traditionally been interpreted as being more accurate than lower rates .


We examined the impact of @ increasingly private mailed survey conditions-ranging from potentially identifiable to completely anonymous-on survey response and on respondents ' representativeness of the underlying sampling frame , completeness in answering sensitive survey items , and disclosure of sensitive information .


We also examined the impact of @ incentives ( $ @ versus $ @ ) on these outcomes .


A @X@ factorial , randomized controlled trial of @ representatively selected , male Gulf War I era veterans who had applied for United States Department of Veterans Affairs ( VA ) disability benefits .


Men were asked about past sexual assault experiences , childhood abuse , combat , other traumas , mental health symptoms , and sexual orientation .


We used a novel technique , the pre-merged questionnaire , to link anonymous responses to administrative data .


Response rates ranged from @ % to @ % across privacy conditions ( p = @ ) and from @ % to @ % across incentives ( p = @ ) .


Respondents ' characteristics differed by privacy and by incentive assignments , with completely anonymous respondents and $ @ respondents appearing least different from their non-respondent counterparts .


Survey completeness did not differ by privacy or by incentive .


No clear pattern of disclosing sensitive information by privacy condition or by incentive emerged .


For example , although all respondents came from the same sampling frame , estimates of sexual abuse ranged from @ % to @ % across privacy conditions , with the highest estimate coming from the intermediate privacy condition ( p = @ ) .


Greater privacy and larger incentives do not necessarily result in higher disclosure rates of sensitive information than lesser privacy and lower incentives .


Furthermore , disclosure of sensitive or stigmatizing information under differing privacy conditions may have less to do with promoting or impeding participants ' `` honesty '' or `` accuracy '' than with selectively recruiting or attracting subpopulations that are higher or lower in such experiences .


Pre-merged questionnaires bypassed many historical limitations of anonymous surveys and hold promise for exploring non-response issues in future research .


Leaky gut , or intestinal permeability , is the phenomenon of the gut wall exhibiting increased absorbency .


It is pretty well recognised that an altered or damaged bowel lining or gut wall may result from unbalanced diet , parasites , infection , or medications and that this allows substances such as toxins , microbes , undigested food , or waste to leak through .


As a natural consequence , this prompts the body to initiate an immune reaction leading to potentially severe health conditions .


Different strategies may be used to improve , at least temporarily , the physiological intestinal barrier .


The use of specific beneficial microorganisms , such as lactobacilli and bifidobacteria , has been suggested as an innovative tool to counteract an improper level of intestinal permeability .


The association of bacteria with specific gelling agents , such as gums , may represent an improvement since these molecules are able to form hydrophilic gels that distribute uniformly over the inner intestinal surface .


This pilot study was undertaken to evaluate intestinal permeability in subjects treated with a gelling complex , an association of tara gum and the microorganism Streptococcus thermophilus ST@ ( DSM @ ) , which has a well-demonstrated in vitro ability to synthesise and secrete exopolysaccharides ( EPSs ) .


Twenty-five healthy subjects were enrolled in this human intervention , double-blind , placebo-controlled , pilot trial ( age between @ and @ y , mean @ ) .


Subjects were then randomised into @ groups : group A ( @ subjects ) was given an active formulation containing @ mg of tara gum and @ billion viable cells of S. thermophilus ST@ , whereas group B ( @ subjects ) was given a placebo formulation .


All the subjects participating in the study were directed to take @ dose per day for @ consecutive days .


The presence and concentration of exopolysaccharides ( EPSs ) in the faeces was determined at time @ ( d@ ) , after @ days of treatment ( d@ ) , and at the end of the @-week follow-up period ( d@ ) .


The monosaccharide composition of EPSs was used to quantify the possible contribution of tara gum to the amount of polysaccharides detected in the faecal material .


Intestinal permeability was evaluated at the same time by means of the lactitol/mannitol ratio ( small intestine permeability ) and sucralose concentration ( colonic permeability ) in urine specimens sampled after specified times .


A statistical comparison was made between the concentration of EPSs , the lactulose/mannitol ratio , and the amount of excreted sucralose in the @ groups at d@ , d@ , and d@ .


In the active group , supplementation with S. thermophilus ST@ and tara gum was able to significantly increase the faecal EPSs concentration compared with placebo ( from @ mg/g to @ mg/g after @ d , P < @ ) .


An interesting decrease in intestinal permeability , both of the small bowel and in the colon , was also recorded .


The L/M ratio diminished from @ in the active group to @ and @ after @ and @ days , respectively ( P = @ and P = @ compared with placebo ) .


The sucralose concentration decreased from @ mg to @ mg and @ mg ( P = @ and P = @ compared with placebo ) at the end of the supplementation period and after the follow-up , respectively .


No significant differences were recorded in the placebo after @ days or at the end of the follow-up .


The association of the EPSs produced by S. thermophilus ST@ and tara gum seems capable of significantly improving the intestinal functional barrier in healthy subjects .


A wider study in subjects presenting impaired gut permeability would be useful in the future to confirm the positive results from this pilot trial .


In any case , our findings are consistent with the parallel increase in exopolysaccharide concentration in the faecal material , thus suggesting the effective ability of the strain used to secrete EPSs in the gut lumen .


An innovative approach of this type may be useful in helping to restore the physiological barrier by means of a merely natural and mechanical action .


Studies in healthy individuals show that exerting self-control consumes cognitive resources , which reduces subsequent self-control performance .


Restoring the availability of blood glucose eliminates this impairment .


Patients with schizophrenia are found to have self-regulatory dysfunctions .


This study aims to investigate whether patient 's ( a ) glucose facilitation effects will be impaired , and ( b ) will have exaggerated depletion in a self-control task .


@ patients with schizophrenia-spectrum disorders and @ normal controls were recruited .


A two drinks ( glucose vs. placebo ) two depleting phases ( self-control depleted vs. non-depleted ) between-groups design was used .


We examined the blood glucose levels before and after the selfcontrol depletion phase and the subsequent performances in two self-control tasks ( handgrip and Stroop tests ) after the drink condition .


The four groups ( depletingglucose , depletingplacebo , non-depletingglucose and nondepletingplacebo ) of both patients and normal controls were comparable on a number of characteristics .


The change in blood glucose level in the depleting group was significantly different from those in the non-depleting group .


Twotwo between-subjects ANOVAs were carried out to test the performances in the handgrip and Stroop tasks .


Significant interactions were found in healthy controls regarding both tasks .


However , a significant interaction was only found in patients regarding the handgrip task but not the Stroop task .


This study demonstrated an abnormal glucose facilitation effect in patients during a cognitive self-control task but not during a physical self-control task .


The findings also suggested for the first time that a self-control depletion effect is intact in patients with schizophrenia .


To investigate the neurobehavioral pattern of recovery of consciousness as reflected by performance on the subscales of the Coma Recovery Scale-Revised ( CRS-R ) .


Retrospective item response theory ( IRT ) and factor analysis .


Inpatient rehabilitation facilities .


Rehabilitation inpatients ( N = @ ) with posttraumatic disturbance in consciousness who participated in a double-blinded , randomized , controlled drug trial .


Not applicable .


Scores on CRS-R subscales .


The CRS-R was found to fit factor analytic models adhering to the assumptions of unidimensionality and monotonicity .


In addition , subscales were mutually independent based on residual correlations .


Nonparametric IRT reaffirmed the finding of monotonicity .


A highly constrained confirmatory factor analysis model , which imposed equal factor loadings on all items , was found to fit the data well and was used to estimate a @-parameter IRT model .


This study provides evidence of the unidimensionality of the CRS-R and supports the hierarchical structure of the CRS-R subscales , suggesting that it is an effective tool for establishing diagnosis and monitoring recovery of consciousness after severe traumatic brain injury .


A hamstring injury is one of the most common types of injury affecting athletes .


Despite this , the optimal management of hamstring muscle injuries is not yet defined .


The effect of autologous platelet-rich plasma ( PRP ) therapy on the recovery of hamstring injuries is unclear .


To investigate the effect of a single PRP injection in the treatment of grade @ hamstring muscle injuries .


Randomized controlled trial ; Level of evidence , @ .


Twenty-eight patients diagnosed with an acute hamstring injury were randomly allocated to autologous PRP therapy combined with a rehabilitation program or a rehabilitation program only .


The primary outcome of this study was time to return to play .


In addition , changes in pain severity and pain interference scores over time were examined .


Patients in the PRP group achieved full recovery significantly earlier than controls ( P = @ ) .


The mean time to return to play was @ @ days and @ @ days for the PRP and control groups , respectively ( t ( @ ) = @ , P = @ ) .


-LSB- corrected -RSB- .


Significantly lower pain severity scores were observed in the PRP group throughout the study .


However , no significant difference in the pain interference score was found between the @ groups .


A single autologous PRP injection combined with a rehabilitation program was significantly more effective in treating hamstring injuries than a rehabilitation program alone .


Many environmental and dietary influences can cause immune cells to produce biological mediators that increase airway inflammation .


A high-fat meal ( HFM ) is one stimulus that increases airway inflammation in healthy individuals .


Supplementation with omega-@ fatty acids can reduce inflammation systemically and may be beneficial to the airways .


To determine if omega-@ fatty acid supplementation via fish oil would mitigate the airway inflammatory response induced by a single HFM .


Seventeen non-asthmatic men ( @ @ years . )


were supplemented with @,@ mg day ( -@ ) fish oil or a placebo for @ weeks .


Fractional exhaled nitric oxide ( FENO ; a marker of airway inflammation ) , impulse oscillometry ( a measure of respiratory impedance ) , pulmonary function , and triglycerides were measured prior to and @ h following a HFM .


Following a HFM , triglycerides increased in both fish oil and placebo groups compared to pre-HFM ( ~ @ and ~ @ % , respectively , p < @ ) .


The percent increase in FENO was greater in the placebo group compared to the fish oil group ( @ @ vs. -@ @ % , respectively , p < @ ) .


A significant correlation was observed between blood triglycerides and FENO in the placebo group ( r = @ ; p < @ ) , but not the fish oil group ( p = @ ) .


A single HFM increases airway inflammation and omega-@ fatty acid supplementation via fish oil protects against HFM associated changes in airway health .


Preclinical data suggest that triple-negative breast cancers are sensitive to interstrand crosslinking agents , and that synergy may exist for the combination of a taxane , trastuzumab , and a platinum salt for HER@-positive breast cancer .


We therefore aimed to assess the efficacy of the addition of carboplatin to neoadjuvant therapy for triple-negative and HER@-positive breast cancer .


Patients with previously untreated , non-metastatic , stage II-III , triple-negative breast cancer and HER@-positive breast cancer were enrolled .


Patients were treated for @ weeks with paclitaxel ( @ mg/m ( @ ) once a week ) and non-pegylated liposomal doxorubicin ( @ mg/m ( @ ) once a week ) .


Patients with triple-negative breast cancer received simultaneous bevacizumab ( @ mg/kg intravenously every @ weeks ) .


Patients with HER@-positive disease received simultaneous trastuzumab ( @ mg/kg initial dose with subsequent doses of @ mg/kg intravenously every @ weeks ) and lapatinib ( @ mg daily ) .


Patients were randomly assigned in a @:@ ratio with dynamic allocation and minimisation , stratified by biological subtype and Ki-@ level to receive , at the same time as the backbone regimens , either carboplatin ( AUC @ -LSB- @ for the first @ patients -RSB- once a week ) or no carboplatin .


The primary endpoint the proportion of patients who achieved a pathological complete response ( defined as ypT@ ypN@ ) , analysed for all patients who started treatment ; a p value of less than @ was deemed significant for the primary endpoint .


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


@ patients were randomly assigned to receive carboplatin and @ to no additional carboplatin , of whom @ and @ started treatment , respectively .


In this final analysis , @ patients ( @ % , @ % CI @-@ ) in the carboplatin group achieved a pathological complete response , compared with @ patients ( @ % , @-@ ) without carboplatin ( odds ratio @ , @ % CI @-@ ; p = @ ) .


Of the patients with triple-negative breast cancer , @ ( @ % , @-@ ) of @ patients achieved a pathological complete response with carboplatin , compared with @ ( @ % , @-@ ) of @ without ( p = @ ) .


Of the patients with HER@-positive tumours , @ ( @ % , @-@ ) of @ patients achieved a pathological complete response with carboplatin compared with @ ( @ % , @-@ ) of @ without ( p = @ ; test for interaction p = @ ) .


Haematological and non-haematological toxic effects that were significantly more common in the carboplatin group than in the no-carboplatin group included grade @ or @ neutropenia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , grade @ or @ anaemia ( @ -LSB- @ % -RSB- vs one -LSB- < @ % -RSB- ) , grade @ or @ thrombocytopenia ( @ -LSB- @ % -RSB- vs one -LSB- < @ % -RSB- ) , and grade @ or @ diarrhoea ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) ; carboplatin was more often associated with dose discontinuations ( @ -LSB- @ % -RSB- with carboplatin and @ -LSB- @ % -RSB- without carboplatin ; p = @ ) .


The frequency of grade @ or @ haematological events decreased from @ % ( n = @ ) to @ % ( n = @ ) and grade @ or @ non-haematological events from @ % ( n = @ ) to @ % ( n = @ ) in the carboplatin arm when the dose of carboplatin was reduced from AUC @ to @ .


The addition of neoadjuvant carboplatin to a regimen of a taxane , an anthracycline , and targeted therapy significantly increases the proportion of patients achieving a pathological complete response .


This regimen seems to increase responses in patients with triple-negative breast cancer , but not in those with HER@-positive breast cancer .


To compare change in dietary intake , with an emphasis on food groups and food intake behaviour , over time across treatment arms in a diabetes prevention trial and to assess the differences in dietary intake among demographic groups within treatment arms .


Data are from the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study .


Participants were randomized to a lifestyle intervention ( n = @ ) , metformin ( n = @ ) or placebo ( n = @ ) for an average of @years , after which the initial results regarding the benefits of the lifestyle intervention were released and all participants were offered a modified lifestyle intervention .


Dietary intake was assessed using a food frequency questionnaire at baseline and at @ , @ , @ and @years after randomization .


Compared with the metformin and placebo arms , participants in the lifestyle arm maintained a lower total fat and saturated fat and a higher fibre intake up to @years after randomization and lower intakes of red meat and sweets were maintained for up to @years .


Younger participants had higher intakes of poultry and lower intakes of fruits compared with their older counterparts , particularly in the lifestyle arm .


Black participants tended to have lower dairy and higher poultry intakes compared with white and Hispanic participants .


In the lifestyle arm , men tended to have higher grain , fruit and fish intakes than women .


Changes in nutrient intake among participants in the lifestyle intervention were maintained for up to @years .


Younger participants reported more unhealthy diets over time and thus may benefit from additional support to achieve and maintain dietary goals .


Physical exercise training aims at reducing disease-specific impairments and improving quality of life in patients with chronic obstructive pulmonary disease ( COPD ) .


COPD exacerbations in particular negatively impact COPD progression .


Physical therapy intervention seems indicated to influence exacerbations and their consequences .


However , information on the effect of physical therapy on exacerbation occurrence is scarce .


This study aims to investigate the potential of a protocol-directed physical therapy programme as a means to prevent or postpone exacerbations , to shorten the duration or to decrease the severity of exacerbations in patients with COPD who have recently experienced an exacerbation .


Besides , this study focuses on the effect of protocol-directed physical therapy on health status and quality of life and on cost-effectiveness and cost-utility in patients with COPD who have recently experienced an exacerbation .


A prospective cohort of @ COPD patients in all GOLD stages will be constructed .


Patients will receive usual multidisciplinary COPD care including guideline-directed physical therapy .


Patients in this cohort who have GOLD stage @ to @ ( post-bronchodilator FEV@/FVC < @ and FEV@ < @ % of predicted ) , who receive reimbursement by health insurance companies for physical therapy ( post-bronchodilator Tiffeneau-index < @ ) and who experience a COPD exacerbation will be asked within @ days to participate in a cohort-nested prospective randomised controlled trial ( RCT ) .


In this RCT , the intervention group will receive a strict physical therapy programme for patients with COPD .


This protocol-directed physical therapy ( pdPT ) will be compared to a control group that will receive sham-treatment , meaning no or very low-intensity exercise training ( ST ) .


An economic evaluation will be embedded in the RCT .


Anthropometric measurements , comorbidities , smoking , functional exercise capacity , peripheral muscle strength , physical activity level , health related quality of life , patients ' perceived benefit , physical therapy compliance , motivation level , level of effective mucus clearance , exacerbation symptoms and health care contacts due to COPD will be recorded .


Follow-up measurements are scheduled at @ and @ weeks , @ , @ , @ and @ months after inclusion .


Ways to minimise potential problems regarding the execution of this study will be discussed .


An imbalance between Th@ and Th@ cells is involved in allergic rhinitis ( AR ) that may be improved by probiotics .


To test the efficacy of the probiotic Lactobacillus paracasei subsp .


paracasei LP-@ , a double-blind , placebo-controlled , randomized trial was carried out in patients with AR to grass pollen treated with loratadine and presenting altered quality of life .


Subjects with persistent AR , symptomatic during the grass pollen season , and a positive skin test or specific immunoglobulin E to grass pollens were included by general practitioners ( GPs ) .


All received loratadine for @ weeks .


The primary end point was the improvement in Rhinitis Quality of Life ( RQLQ ) global score at the fifth week of LP-@ consumption compared with placebo ( in addition to loratadine ) .


Secondary end points included nasal and ocular symptoms ( individual and total symptom scores ) , visual analogue scale and time of first exacerbation of the symptoms when loratadine was stopped .


A total of @ subjects were included .


Using intent-to-treat analysis , the RQLQ global score decreased significantly more in the LP-@ group than in the placebo group ( P = @ , difference = -@ ( @ % confidence interval ( CI ) : -@ ; -@ ) ) .


No significant differences were noted for the change of the rhinitis total symptom score @ global score between groups ( P = @ , difference = -@ ( @ % CI : -@ ; @ ) ) .


Significant differences in ocular symptoms ( RQLQ ) were observed between groups ( P = @ , difference = -@ ( @ % CI : -@ ; -@ ) ) .


This study performed by GPs shows that LP-@ improves the quality of life of subjects with persistent AR who are currently being treated with an oral H@-antihistamine .


Whereas nasal symptoms had not changed , ocular symptoms had consistently improved .


HIV-associated diarrhea remains a significant concern with limited treatment options .


To determine the optimal dose , efficacy , and safety of crofelemer for noninfectious diarrhea .


This randomized , double-blind , phase @ trial used a @-stage design .


Both stages included @-week screening , @-week placebo-controlled treatment , and @-week placebo-free ( open-label ) extension phases .


In stage I , @ HIV-seropositive patients with chronic diarrhea were randomized to crofelemer @ mg , @ mg , or @ mg or placebo twice daily .


Using a prospective analysis , the @-mg twice-daily dose was selected for stage II .


In stage II , @ new patients were randomized to crofelemer @ mg twice daily or placebo for @ weeks .


Primary efficacy analysis was the percentage of patients ( stages I/II combined ) who achieved clinical response ( defined as @ watery stools/week during @ of @ weeks ) .


During the placebo-free extension phase , response ( @ watery stools ) was assessed weekly .


Significantly more patients receiving crofelemer @ mg achieved clinical response versus placebo ( @ % vs @ % ; one-sided , P = @ ) .


Crofelemer @ mg resulted in a greater change from baseline in number of daily watery bowel movements ( P = @ ) and daily stool consistency score ( P = @ ) versus placebo .


During the placebo-free extension phase , percentages of weekly responders ranged from @ % to @ % at weeks @ to @ .


Crofelemer was minimally absorbed , well tolerated , did not negatively impact clinical immune parameters , and had a safety profile comparable to placebo .


In HIV-seropositive patients taking stable antiretroviral therapy , crofelemer provided significant improvement in diarrhea with a favorable safety profile .


To examine the influence of epidural and intravenous ( IV ) lidocaine , and height of the epidural sensory block , on the dose of propofol required for induction of general anesthesia .


Randomized controlled study .


University hospital .


@ adult , ASA physical status @ and @ patients , aged @ to @ years , undergoing elective abdominal surgery .


Patients were randomized to @ groups : the epidural saline control group ( Group C ; L@-L@ puncture , epidural and IV saline ) , the IV lidocaine group ( Group IV ; L@-L@ puncture , saline epidural , IV lidocaine @ mg/kg ) , the lumbar epidural lidocaine group ( Group EL ; L@-L@ puncture , @ % lidocaine epidural , IV saline ) , and the thoracic epidural lidocaine group ( Group ET ; T@-T@ puncture , @ % lidocaine epidural , IV saline ) .


Two minutes after the beginning of the infusion of IV lidocaine or saline , propofol anesthesia was initiated .


Mean arterial blood pressure ( MAP ) , heart rate ( HR ) , and sensory block height were monitored .


The induction dose of propofol , its estimated effect-site concentration ( Ce ) , and plasma concentration were measured at various time points .


Finally , we recorded the time taken for the bispectral index ( BIS ) to decrease to @ , the plasma concentration of lidocaine at induction , and the occurrence of adverse events .


The induction time ( when BIS reached @ ) also was recorded .


The induction propofol dose , Ce , and plasma concentration of propofol when BIS equaled @ were significantly lower in Group IV , Group EL , and Group ET than Group C.


The above parameters in Group ET ( T@ - T@ puncture ) were significantly less than in Group EL ( L@ - L@ puncture ) .


The induction doses of propofol and plasma concentration of propofol and lidocaine were significantly higher in Group IV than in Groups EL or ET .


Epidural and IV lidocaine reduce the dose of propofol required to induce general anesthesia .


Administration of lidocaine via the epidural route reduces anesthetic requirements more so than the IV route .


Propofol requirements were further reduced in patients with higher sensory epidural block .


This study sought to identify the profile of circulating microRNAs ( miRNAs ) in type @ diabetes ( T@D ) and its response to changes in insulin sensitivity .


The circulating miRNA profile was assessed in a pilot study of @ men : @ with normal glucose tolerance ( NGT ) and @ T@D patients .


The association of @ circulating miRNAs with T@D was cross-sectionally validated in an extended sample of @ NGT vs. @ T@D subjects ( @ nonobese and @ obese men ) and longitudinally in @ T@D patients who were recruited in a randomized , double-blinded , and placebo-controlled @-month trial of metformin treatment .


Circulating miRNAs were also measured in seven healthy volunteers before and after a @-h hyperinsulinemic-euglycemic clamp and insulin plus intralipid/heparin infusion .


Cross-sectional studies disclosed a marked increase of miR-@-@p , miR-@-@p , and miR-@ and decreased miR-@-@p , miR-@b , miR-@ , miR-@ , miR-@b , miR-@-@p , and miR-@ in T@D patients .


Multiple linear regression analyses revealed that miR-@-@p and miR-@-@p contributed independently to explain @ % ( P < @ ) of fasting glucose variance after controlling for confounders .


A discriminant function of four miRNAs ( miR-@-@p , miR-@-@p , miR-@ , and miR-@ ) was specific for T@D with an accuracy of @ % ( P < @ ) .


Metformin ( but not placebo ) led to significant changes in circulating miR-@ ( @ % ; P = @ ) , miR-@-@p ( -@ % ; P = @ ) , and miR-@ ( -@ % ; P = @ ) , in parallel to decreased fasting glucose and HbA@c .


Furthermore , while insulin infusion during clamp decreased miR-@ ( -@ % ; P = @ ) , the intralipid/heparin mixture increased circulating miR-@ ( @ % ; P = @ ) and miR-@-@p ( @ % ; P = @ ) .


This study depicts the close association between variations in circulating miRNAs and T@D and their potential relevance in insulin sensitivity .


Previous studies indicated that a single session of repeated-slip exposure can reduce over @ % of laboratory-induced falls among older adults .


The purpose of this study was to determine to what degree such perturbation training translated to the reduction of older adults ' annual falls risk in their everyday living .


Two hundred and twelve community-dwelling older adults ( @ years old ) were randomly assigned to either the training group ( N = @ ) , who then were exposed to @ unannounced repeated slips , or the control group ( N = @ ) , who merely experienced one slip during the same walking in the same protective laboratory environment .


We recorded their falls in the preceding year ( through self-reported history ) and during the next @ months ( through falls diary and monitored with phone calls ) .


With this single session of repeated-slip exposure , training cut older adults ' annual risk of falls by @ % ( from @ % to @ % , p < @ ) .


Those who experienced merely a single slip were @ times more likely to fall during the same @-month follow-up period ( p < @ ) than those who experienced the @ repeated slips .


Such training effect was especially prominent among those who had history of falls .


A single session of repeated-slip exposure could improve community-dwelling older adults ' resilience to postural disturbances and , hence , significantly reduce their annual risk of falls .


The effect of antipsychotics ( APs ) on negative symptoms is controversial .


The present study assessed negative symptoms in healthy volunteers without any source of primary negative symptoms after single doses of haloperidol and risperidone .


Twenty-five healthy subjects were included in this randomized , placebo-controlled , single-dose ( haloperidol @mg and risperidone @ mg ) crossover and double-blind clinical trial .


Negative symptoms were assessed by observer-rated scales and with a self-report scale .


Possible confounding effects considered were extrapyramidal symptoms ( EPS ) and sedative effects .


The occupation of striatal dopamine D@ receptors was also determined .


Risperidone induced a wide range of negative symptoms such as alogia , blunted affect , avolition/apathy , and attention impairment , whereas haloperidol only induced the avolition/apathy subdomain .


Most of the effects of risperidone in healthy volunteers , with the exception of its effects on avolition/apathy , were attributable to AP-induced EPS .


Haloperidol did not cause significant EPS after administration .


No effect of sedation or psychomotor performance was observed on negative symptoms .


Single doses of both haloperidol and risperidone induced nonmotor secondary negative symptoms in healthy volunteers .


The clinical findings are especially relevant in view of the impact of negative symptoms on poor functioning .


They may help to guide clinicians in their choice of APs ( http://clinicaltrials.gov/ct@/show/NCT@ ) .


Increasing physical activity is known to have health benefits for people with hypertension and related conditions .


Current general practitioner referrals for gym-based exercise increase physical activity but meta-analyses show that while these are effective the absolute health risk reduction is small due to patients failing to maintain activity levels over time .


This study assesses the effectiveness of two sports-oriented interventions that are intended to bridge the intention-behaviour gap and thus increase the likelihood of sustained increases in physical activity .


Four-arm randomised controlled trial .


The study tests two types of intervention that are intended to increase physical activity among currently inactive @ - to @-year-old people with hypertension or high-normal blood pressure .


This study will assess the effectiveness of a @-week sports-oriented exercise programme , the efficacy of a web-delivered self-help tool to promote and support sports participation and healthy behaviour change and the effect of these interventions in combination .


The control arm will be a standard care general practitioner referral for gym-based exercise .


Participants will be allocated using block randomisation .


The first author and primary analyst is blinded to participant allocation .


The primary outcome measures will be time spent in physical activity assessed in metabolic equivalent minutes per week using the International Physical Activity Questionnaire @year after commencement of the intervention .


Secondary outcomes include increased involvement in sporting activity and biomedical health outcomes including change in body mass index , and waist and hip measurement and reductions in blood pressure .


If proven to be superior to general practitioner referrals for gym-based exercise , these sports-oriented interventions would constitute low-cost alternatives .


The next stage would be a full economic evaluation of the interventions .


We aimed to investigate the association between baseline plasma fatty acids profile and the risk of future major cardiovascular events in patients with a history of ischaemic heart disease or ischemic stroke .


Baseline plasma fatty acids as well as established cardiovascular risk factors were measured in @,@ patients enrolled in the SUpplementation with FOLate , vitamins B-@ and B-@ and/or OMega-@ fatty acids randomized controlled trial .


Incident major cardiovascular , cardiac and cerebrovascular events were ascertained during the @ years of follow up .


Hazard ratios were obtained from Cox proportional hazards models after adjustment for cardiovascular risk factors .


During the follow-up , @ , @ and @ patients had major cardiovascular , cardiac and cerebrovascular events respectively .


Upon adjustment for gender , initial event , baseline age and BMI , the risk of developing a major cardiovascular event decreased significantly in successive quartiles of arachidonic acid ( P trend < @ ) , total omega @ polyunsaturated fatty acids ( P trend < @ ) , docosapentaenoic acid ( P trend < @ ) , docosahexaenoic acid ( P trend < @ ) , eicosapentaenoic acid + docosahexaenoic acid ( P trend < @ ) and eicosapentaenoic acid + docosapentaenoic acid + docosahexaenoic acid ( P trend < @ ) .


This inverse association was borderline significant with increased quartiles of stearidonic acid ( P trend < @ ) .


In the full model , only stearidonic acid remained inversely associated with the risk of developing a major cardiovascular event ( P trend < @ ) , a cardiac event ( P trend < @ ) or a cerebrovascular event ( P trend < @ ) , while arachidonic acid was inversely associated with the risk a cerebrovascular event ( P trend < @ ) .


The inverse association of long chain omega @ polyunsaturated fatty acids with recurrence of Cardiovascular diseases was mainly driven by well-known cardiovascular risk factors .


Evaluate the pharmacokinetics ( PK ) , safety , and tolerability of single doses of once-daily USL@ , Qudexy XR ( topiramate ) extended-release capsules , over a wide dosing range .


Two single-dose , phase I studies in healthy adults were used to evaluate the PK profile and maximum tolerated dose ( MTD ) of USL@ from @-@ ,@ mg .


Standard PK parameters assessed included area under the plasma concentration-time curve ( AUC ) and maximum plasma concentration ( Cmax ) .


Dose proportionality , linearity , and intersubject and intrasubject variability ( coefficient of variation -LSB- % CV -RSB- ) of AUC and Cmax were evaluated .


Investigator-reported adverse events ( AEs ) were obtained throughout the studies .


After the initial increase in plasma concentration levels immediately following administration of USL@ @-@ ,@ mg , plasma topiramate concentration-time profiles were flat up to @ h after dosing .


AUC was dose proportional from @-@ ,@ mg , and Cmax was dose proportional from @-@ ,@ mg ; both AUC and Cmax were linear across the entire dose range .


Low intersubject and intrasubject % CV values were observed for AUC@-t , AUC@ - , and Cmax ( intersubject % CV : @ , @ , and @ % , respectively ; intrasubject % CV of dose-normalized mean values : @ , @ , and @ % , respectively ) .


USL@ was generally safe and well tolerated with MTD established at @,@ mg .


These results demonstrate that USL@ provides consistent plasma topiramate exposure across an extended-dosing interval and predictable plasma topiramate concentrations over a wide dosing range .


Overall , the favorable safety profile and consistency of exposure suggest once-daily USL@ can be a useful treatment option for patients with epilepsy .


Whether a restrictive threshold for hemoglobin level in red-cell transfusions , as compared with a liberal threshold , reduces postoperative morbidity and health care costs after cardiac surgery is uncertain .


We conducted a multicenter , parallel-group trial in which patients older than @ years of age who were undergoing nonemergency cardiac surgery were recruited from @ centers in the United Kingdom .


Patients with a postoperative hemoglobin level of less than @ g per deciliter were randomly assigned to a restrictive transfusion threshold ( hemoglobin level < @ g per deciliter ) or a liberal transfusion threshold ( hemoglobin level < @ g per deciliter ) .


The primary outcome was a serious infection ( sepsis or wound infection ) or an ischemic event ( permanent stroke -LSB- confirmation on brain imaging and deficit in motor , sensory , or coordination functions -RSB- , myocardial infarction , infarction of the gut , or acute kidney injury ) within @ months after randomization .


Health care costs , excluding the index surgery , were estimated from the day of surgery to @ months after surgery .


A total of @ patients underwent randomization ; @ participants withdrew , leaving @ in the restrictive-threshold group and @ in the liberal-threshold group .


Transfusion rates after randomization were @ % and @ % in the two groups , respectively .


The primary outcome occurred in @ % of the patients in the restrictive-threshold group and @ % of the patients in the liberal-threshold group ( odds ratio , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ) ; there was no indication of heterogeneity according to subgroup .


There were more deaths in the restrictive-threshold group than in the liberal-threshold group ( @ % vs. @ % ; hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) .


Serious postoperative complications , excluding primary-outcome events , occurred in @ % of participants in the restrictive-threshold group and @ % of participants in the liberal-threshold group .


Total costs did not differ significantly between the groups .


A restrictive transfusion threshold after cardiac surgery was not superior to a liberal threshold with respect to morbidity or health care costs .


( Funded by the National Institute for Health Research Health Technology Assessment program ; Current Controlled Trials number , ISRCTN@ . )


To compare the efficacy differences between acupuncture at Zhibian ( BL @ ) through Shuidao ( ST @ ) and regular acupuncture for polycystic ovary syndrome .


One hundred and one patients , by using random digital table , were randomly divided into an observation group ( @ cases ) and a control group ( @ cases ) .


Patients in the observation group were treated with acupuncture at Zhibian ( BL @ ) through Shuidao ( ST @ ) as main acupoints , and accompanied acupoints were selected according to syndrome differentiation .


Elongated needles ( @ mm in length ) were inserted at Zhibian ( BL @ ) with an angle of @ with sagittal plane .


The insertion depth was @-@ mm , reaching Shuidao ( ST @ ) and making acupuncture sensation arrive at diseased location .


Patients in the control group were treated at the same acupoints with regular acupuncture technique .


The menstruation condition was ignored for patients in both groups .


The treatment was given once a day , @ times as one session , and @ consecutive sessions were given .


The basic temperature and level of sex hormone were observed before and after treatment in the two groups , and clinical efficacy was compared .


The cured rate was @ % ( @/@ ) and the effective rate was @ % ( @/@ ) in the observation group after treatment , which was significantly superior to @ % ( @/@ ) and @ % ( @/@ ) in the control group ( both P < @ ) .


The number of patients with typical biphasic fever and patients with atypical biphasic fever in the observation group was higher , than that in the control group , but that of unidirectional temperature was less than that in the control group ( P < @ ) .


After treatment , the follicle-stimulating hormone ( FSH ) , luteinizing hormone ( LH ) , LH/FSH , testos terone ( T ) were significantly reduced in the observation group ( P < @ , P < @ ) ; the LH and T were also apparently reduced in the control group ( P < @ , P < @ ) .


The reduction of FSH , LH , LH/FSH and T in the observation group after treatment was more significant than that in the control group ( P < @ , P < @ ) .


Acuouncture at Zhibian ( BL @ ) through Shuidao ( ST @ ) could significantly improve the basic temperature of patients with polycystic ovary syndrome , and regulate hormone level of reproductive endocrine , which is superior to regular acupuncture .


Prospective cohort studies support the hypothesis that statin drug users have a lower risk of aggressive prostate cancer .


Whether statin drug use influences the risk of screen detected disease is less clear , possibly because of complex detection biases .


Thus , we investigated this association in a setting in which men had low baseline serum prostate specific antigen concentration and were screened annually .


We performed a cohort study of @,@ men @ years old or older at randomization to the placebo arm of PCPT ( Prostate Cancer Prevention Trial ) .


The men reported new use of medications quarterly .


We estimated the multivariable adjusted HR of prostate cancer ( @ cases in @,@ person-years ) for statin drug use and duration of use during the trial using Cox proportional hazards regression .


During @ years of followup statin drug use during the trial was not associated with the risk of total prostate cancer ( HR @ , @ % CI @-@ @ ) , or lower grade ( HR @ , @ % CI @-@ @ ) or higher grade ( HR @ , @ % CI @-@ @ ) prostate cancer .


Duration of use during followup was also not associated with the risk of total , or lower or higher grade disease ( p trend = @ , @ and @ , respectively ) .


These prospective results do not support the hypothesis that statin drugs protect against prostate cancer in the setting of regular prostate cancer screening .


Use of sedative agents for difficult to manage children during dental procedures has been indicated for years , but neither the agent nor the route has been found to be ideal .


The aim of the study was to evaluate and compare the efficacy and safety of oral dexmedetomidine ( D ) and ketamine ( K ) in producing moderate sedation among uncooperative pediatric dental patients .


This prospective , triple-blind , randomized comparative study included @ ASA grade I children of both sexes aged @-@years , who satisfied all the inclusion criteria .


They were randomly divided into four groups and ketamine @mgkg ( -@ ) ( K ) or dexmedetomidine @gkg ( -@ ) ( D@ ) , @gkg ( -@ ) ( D@ ) and @gkg ( -@ ) ( D@ ) were given orally .


Similar dental procedures were performed in these patients , and effects of these drugs were assessed in terms of changes in vital signs , onset and duration of sedation , analgesia , and amnesia .


Secondary outcomes such as level of sedation , behavior , adverse effects , and overall success were also measured .


The onset of sedation was significantly rapid with K and D@ as compared to D@ and D@ .


Recovery from sedation was fastest in group D@ .


Intra - and postoperative analgesia and anterograde amnesia were highest with K and least with D@ , while D@ produced analgesia comparable to K.


In K treated group , vomiting was observed in five patients and two patients exhibited emergence phenomenon .


Overall , highest success rate was observed in D@ group .


Given by oral route , the novel sedative dexmedetomidine provides dose-dependent effective analgo-sedation , comparable to ketamine , with less adverse effects .


This study compared effectiveness of an enhanced versus standard implementation strategy ( Replicating Effective Programs -LSB- REP -RSB- ) on site-level uptake of Re-Engage , a national program for veterans with serious mental illness .


Mental health providers at @ Veterans Affairs ( VA ) facilities were given REP-based manuals and training in Re-Engage , which involved identifying veterans who had not been seen in VA care for at least one year , documenting their clinical status , and coordinating further health care .


After six months , facilities not responding to REP ( N = @ ) were randomized to receive six months of facilitation ( enhanced REP ) or continued standard REP. Site-level uptake was defined as percentage of patients ( N = @,@ ) with updated documentation or with whom contact was attempted .


Rate of Re-Engage uptake was greater for enhanced REP sites compared with standard REP sites ( @ % versus @ % , p = @ ) .


Total REP facilitation time was @ hours per site for six months .


Added facilitation improved short-term uptake of a national mental health program .


Despite evidence that outcomes are highly valued when they are expected sooner rather than further into the future ( Ainslie , @ ) , limited research effort has been devoted to understanding the role of exercise outcome proximity .


The purpose of this study was to examine how temporal proximity to positive outcomes influences exercisers ' intrinsic motivation .


We expected that focusing people on temporally proximal exercise outcomes would increase intrinsic motivation , especially among low-frequency exercisers .


This online experimental study was completed by @ community exercisers ( Mage = @ , SD = @ ; @ % female ) who reported an average of @ exercise bouts per week ( SD = @ ) .


Participants were randomly assigned to a condition that primed temporally proximal positive exercise outcomes ( i.e. experienced during or directly following an exercise bout ) or temporally distal outcomes ( i.e. experienced after days , months , or years of regular exercise ) .


Participants then reported perceptions of behavioral regulation in exercise .


As expected , the proximal exercise outcome condition elicited increased intrinsic regulation among those participants who exercised less frequently ( i.e. @ SD below the mean ) .