Patients with CKD stages 3b to 4 were randomly assigned to the exercise ( n = 20 ; 11 men ; median age , 63 [ IQR , 57-65 ] years ; median estimated glomerular filtration rate , 28.5 [ IQR , 19.0-32 .0 ] mL/min/1 .73 m ( 2 ) ) or nonexercise control ( n = 18 ; 14 men ; median age , 66 [ IQR , 45-79 ] years ; estimated glomerular filtration rate , 20.5 [ IQR , 16.0-26 .0 ] mL/min/1 .73 m ( 2 ) ) group .


Patients in the exercise group undertook an 8-week progressive resistance exercise program consisting of 3 sets of 10 to 12 leg extensions at 70 % of estimated 1-repetition maximum thrice weekly .


Patients in the control group continued with usual physical activity .


Primary outcomes were related to study feasibility : eligibility , recruitment , retention , and adherence rates .


Secondary outcomes were muscle anatomical cross-sectional area , muscle volume , pennation angle , knee extensor strength , and exercise capacity .


Two - and 3-dimensional ultrasonography of skeletal muscle , dynamometry , and shuttle walk tests at baseline and 8 weeks .


Of 2,349 patients screened , 403 were identified as eligible and 38 enrolled in the study .


33 ( 87 % ) completed the study , and those in the exercise group attended 92 % of training sessions .


No changes were seen in controls for any parameter .


Progressive resistance exercise increased muscle anatomical cross-sectional area , muscle volume , knee extensor strength , and exercise capacity .


No blinded assessors , magnetic resonance imaging not used to assess muscle mass , lack of a healthy control group .


This type of exercise is well tolerated by patients with CKD and confers important clinical benefits ; however , low recruitment rates suggest that a supervised outpatient-based program is not the most practical implementation strategy .


Clinical practice guidelines have been widely developed and disseminated with the aim of improving healthcare processes and patient outcomes but the uptake of evidence-based practice remains haphazard .


There is a need to develop effective implementation methods to achieve large-scale adoption of proven innovations and recommended care .


Clinical networks are increasingly being viewed as a vehicle through which evidence-based care can be embedded into healthcare systems using a collegial approach to agree on and implement a range of strategies within hospitals .


In Australia , the provision of evidence-based care for men with prostate cancer has been identified as a high priority .


Clinical audits have shown that fewer than 10 % of patients in New South Wales ( NSW ) Australia at high risk of recurrence after radical prostatectomy receive guideline recommended radiation treatment following surgery .


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 10 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 .


Australian New Zealand Clinical Trials Registry ( ANZCTR ) : ACTRN12611001251910 .


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


In a randomized crossover study , 16 athletes performed 6 30-s Wingate sprints before completing either an active recovery ( 10 min of cycling and stretching ) or WBV for 10 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 10-min recovery period .


Blood lactate concentration , vertical jump , quadriceps strength , flexibility , rating of perceived exertion ( RPE ) , muscle soreness , and performance during a single 30-s Wingate test were assessed at baseline and 30 and 60 min postexercise .


A subset of participants ( n = 6 ) completed a 3rd identical trial ( 1 wk later ) using a passive 10-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 ( 11.2 % 2.4 % [ mean 95 % CI ] , effect size [ ES ] = 3.1 , and -7.3 % 4.1 % , ES = -2.1 for the 10 min postexercise and postrecovery , respectively ) and passive recovery conditions ( 4.1 % 2.2 % , ES = 1.3 , 10 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 0.3 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 48 hrs after surgery .


Adverse effects related to analgesia , profiles associated with recovery from surgery , and postoperative complications within 30 days after surgery were also evaluated .


This study failed to demonstrate the non-inferiority of ITM-IVPCA ( n = 29 ) to PCTEA ( n = 30 ) with respect to VAS 24 hrs after surgery .


Furthermore , the IT group consumed more fentanyl than the EP group did ( 1247.2263.7 g vs. 1048.971.7 g , p < 0.001 ) .


The IT group took a longer time to ambulate than the EP group ( p = 0.021 ) and had higher incidences of postoperative ileus ( p = 0.012 ) and pulmonary complications ( p = 0.05 ) 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 50 % at-risk subjects in a prevention trial , and the potential of cognitive , imaging , and blood markers .


Sixty-four eligible consenting participants were randomly allocated ( 1:1 ) to 15 g twice daily of creatine monohydrate or placebo for a 6-month double-blind phase followed by a 12-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 17 non-HD controls were enrolled .


Fifteen discontinued treatment ( 2 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 6 and 18 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 = 695 ) from 2 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 2 ( participant gender ) by 2 ( gender of the individual described in the vignette ) by 3 ( 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 3 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 ( 100mg and 140mg ) , in which 1537 patients age 55 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 : 272 y ; BMI : 23.40.7 kg/m2 ) completed the randomized crossover design study which included 3 , 8-h testing days comparing the following 160 kcal afternoon snacks : high-protein yogurt ( 14 g protein/25 g CHO/0 g fat ) ; high-fat crackers ( 0 g protein/19 g CHO/9 g fat ) ; and high-fat chocolate ( 2 g protein/19 g CHO/9 g fat ) .


Participants were acclimated to each snack for 3 consecutive days .


On day 4 , the participants consumed a standardized breakfast and lunch ; the respective snack was consumed 3-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 < 0.01 ) .


No differences in afternoon fullness were detected .


The yogurt snack also delayed eating initiation by approximately 30 min compared to the chocolate snack ( p < 0.01 ) and approximately 20 min vs. crackers ( p = 0.07 ) .


The yogurt snack led to approximately 100 fewer kcals consumed at dinner vs. the crackers ( p = 0.08 ) and chocolate ( p < 0.05 ) .


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 ( 16 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 < 0.05 ) .


Phenylephrine group showed significantly lower umbilical artery blood pH than dopamine group ( P < 0.05 ) .


The Apgar score and blood pressure were comparable between the two groups ( P > 0.05 ) .


Compared to the baseline , both of the two groups showed significantly lowered heart rate during the operation ( P < 0.01 ) .


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 3 studies .


Patients were randomized to infusions of 400-mg solanezumab ( n = 654 ) , or placebo ( n = 660 ) every 4 weeks for 18 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 87 % of the treatment effect on function was driven by the treatment effect on cognition , with the remaining 13 % 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 18-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 2 related studies .


Rural Virginia .


Seventy people with first-degree relatives with CRC and 113 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 1-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-37 ) 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 = 10 ) versus 200,000 IU cholecalciferol ( n = 10 ) versus 400,000 IU cholecalciferol ( n = 10 ) , within 24 hours of new-onset severe sepsis or septic shock .


Blood samples were obtained at baseline ( day 1 ) and on days 3 , 5 , and 7 , to assess total 25-hydroxyvitamin D , as well as vitamin D-binding protein and albumin to calculate bioavailable 25-hydroxyvitamin D. Plasma LL-37 and high-sensitivity C-reactive protein levels were also measured .


At baseline , median ( interquartile range ) plasma 25-hydroxyvitamin D was 17ng/mL ( 13-22ng / mL ) and peaked by day 5 in both intervention groups .


Groups were compared using Kruskal-Wallis tests .


Relative to baseline , on day 5 , median change in biomarkers for placebo , 200,000 IU cholecalciferol , and 400,000 IU cholecalciferol groups , respectively , were as follows : 1 ) total 25-hydroxyvitamin D , 3 % ( -3 % to 8 % ) , 49 % ( 30-82 % ) , and 69 % ( 55-106 % ) ( p < 0.001 ) ; 2 ) bioavailable 25-hydroxyvitamin D , 4 % ( -8 % to 7 % ) , 45 % ( 40-70 % ) , and 96 % ( 58-136 % ) ( p < 0.01 ) ; and 3 ) LL-37 : -17 % ( -9 % to -23 % ) , 4 % ( -10 % to 14 % ) , and 30 % ( 23-48 % ) ( p = 0.04 ) .


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


A positive correlation was observed between bioavailable 25-hydroxyvitamin D and LL-37 ( Spearman = 0.44 ; p = 0.03 ) but not for total 25-hydroxyvitamin D and LL-37 .


High-dose cholecalciferol supplementation rapidly and safely improves 25-hydroxyvitamin D and bioavailable 25-hydroxyvitamin D levels in patients with severe sepsis or septic shock .


Changes in bioavailable 25-hydroxyvitamin D are associated with concomitant increases in circulating LL-37 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 ( 0.26 ) .


Over 39 20 months , 140 of 447 ( 31.3 % ) 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 , 1.99 ; P = 0.004 ) .


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 ( 2.0 mm for navigation vs. 0.6 mm for guides ) .


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


There were statistically significant differences in the times required ( 705 s for navigation vs. 214 s for guides ) and their standard deviations ( 144 s for navigation vs. 98 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 7 to 12 years of age with residual amblyopia resulting from strabismus , anisometropia , or both combined ( visual acuity [ VA ] , 20/50-20 / 400 ) after patching .


Sixteen weeks of oral levodopa or placebo administered 3 times daily while patching the fellow eye 2 hours daily .


Mean change in best-corrected amblyopic-eye VA at 18 weeks .


At 18 weeks , amblyopic-eye VA improved from randomization by an average of 5.2 letters in the levodopa group and by 3.8 letters in the placebo group ( difference adjusted for baseline VA , +1.4 letters ; 1-sided P = 0.06 ; 2-sided 95 % confidence interval , -0.4 to 3.3 letters ) .


No serious adverse effects from levodopa were reported during treatment .


For children 7 to 12 years of age with residual amblyopia after patching therapy , oral levodopa while continuing to patch 2 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 3 study enrolled adults aged 18-55 years with relapsing multiple sclerosis , one or more relapse in the previous 12 months or two or more in the previous 24 months but no relapse in the previous 30 days , and an Expanded Disability Status Scale ( EDSS ) score of 5.5 points or less .


Patients were recruited from 189 sites in 26 countries and randomly assigned ( 1:1:1 ) to once-daily placebo , teriflunomide 7 mg , or teriflunomide 14 mg via an interactive voice recognition system .


Treatment duration was variable , ending 48 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 1 EDSS point sustained for a minimum of 12 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 NCT00751881 .


Between Sept 17 , 2008 , and Feb 17 , 2011 , 1169 patients were randomly assigned to a treatment group , of whom 388 , 407 , and 370 patients received at least one dose of placebo , teriflunomide 7 mg , or teriflunomide 14 mg , respectively .


By the end of the study , the annualised relapse rate was higher in patients assigned to placebo ( 0.50 [ 95 % CI 0.43-0 .58 ] ) than in those assigned to teriflunomide 14 mg ( 0.32 [ 0.27-0 .38 ] ; p = 0.0001 ) or teriflunomide 7 mg ( 0.39 [ 0.33-0 .46 ] ; p = 0.0183 ) .


Compared with placebo , teriflunomide 14 mg reduced the risk of sustained accumulation of disability ( hazard ratio [ HR ] 0.68 [ 95 % CI 0.47-1 .00 ] ; log-rank p = 0.0442 ) ; however , teriflunomide 7 mg had no effect on sustained accumulation of disability ( HR 0.95 [ 0.68-1 .35 ] ; log-rank p = 0.7620 ) .


The most common adverse events were alanine aminotransferase increases ( 32 [ 8 % ] of 385 patients in the placebo group vs 46 [ 11 % ] of 409 patients in the teriflunomide 7 mg group vs 52 [ 14 % ] of 371 patients in the teriflunomide 14 mg group ) , hair thinning ( 17 [ 4 % ] vs 42 [ 10 % ] vs 50 [ 13 % ] ) , and headache ( 42 [ 11 % ] vs 60 [ 15 % ] vs 46 [ 12 % ] ) .


Incidence of serious adverse events was similar in all treatment groups ( 47 [ 12 % ] vs 52 [ 13 % ] vs 44 [ 12 % ] ) .


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 7 mg group , and suicide and septicaemia due to Gram-negative infection complicated by disseminated intravascular coagulopathy in the teriflunomide 14 mg group ) .


Teriflunomide 14 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 14 mg in patients with relapsing multiple sclerosis .


Genzyme , a Sanofi company .


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 .


40 subfertile women , ages 18 to 41years , 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 1.7 cm ( interquartile range : 2.1 ) compared with 3.7 cm ( interquartile range : 4.2 ) during HSG .


The HyFoSy procedure also had a statistically significantly shorter procedure time compared with HSG , with a median of 5.0 minutes ( interquartile range : 3.0 ) for HyFoSy versus 12.5 minutes ( interquartile range : 16.0 ) for HSG .


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


Netherlands National Trial Register NTR3457 .


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 ( 0.5 mg/kg ) and midazolam ( 0.045 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 24 hours after infusion ( mean difference in Impact of Event Scale-Revised score , 12.7 [ 95 % CI , 2.5-22 .8 ] ; P = .02 ) .


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 24-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 .


clinicaltrials.gov Identifier : NCT00749203 .


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 2128 patients 70 years of age with HF .


Patients were divided into three baseline pre-treatment SBP categories ( < 110 , 110-130 , and > 130 mmHg ) .


In addition , we evaluated the influence of SBP ( 130 and > 130 mmHg ) on patients with LVEF < 40 % vs. 40 % .


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 0.85 [ 95 % confidence interval ( CI ) 0.50-1 .45 ] , 0.79 ( 95 % CI 0.61-1 .01 ) , and 0.88 ( 95 % CI 0.72-1 .07 ) , respectively ( P for interaction = 0.61 ) .


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-5172 is an inhibitor of the hepatitis C virus ( HCV ) nonstructural protein 3/4A protease ; MK-5172 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-5172 with peginterferon and ribavirin ( PR ) in treatment-naive patients with chronic HCV genotype 1 infection without cirrhosis .


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


A total of 332 patients received MK-5172 ( 100 , 200 , 400 , or 800 mg ) once daily for 12 weeks in combination with PR .


Patients in the MK-5172 groups received PR for an additional 12 or 36 weeks , based on response at week 4 .


Patients in the control group ( n = 66 ) received a combination of boceprevir and PR , dosed in accordance with boceprevir 's US product circular .


At 24 weeks after the end of therapy , sustained virologic responses were achieved in 89 % , 93 % , 91 % , and 86 % of the patients in the groups given the combination of PR and MK-5172 ( 100 , 200 , 400 , or 800 mg ) , respectively , vs 61 % of controls .


In the MK-5172 group receiving 100 mg , 91 % of patients had undetectable levels of HCV RNA at week 4 and qualified for the short duration of therapy .


The combination of MK-5172 and PR generally was well tolerated .


Transient increases in transaminase levels were noted in the MK-5172 groups given 400 and 800 mg , at higher frequencies than in the MK-5172 groups given 100 or 200 mg , or control groups .


Once-daily MK-5172 ( 100 mg ) with PR for 24 or 48 weeks was highly effective and well tolerated among treatment-naive patients with HCV genotype 1 infection without cirrhosis .


Studies are underway to evaluate interferon-free MK-5172-based regimens .


ClinicalTrials.gov number : NCT01353911 .


This 24-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 159 patients were randomly assigned to two ACT teams , one providing standard ACT ( N585 ) and an ACT Plus team that also provided evidence-based interventions ( N574 ) : 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 65 % to 89 % ) , only 12 of the 74 patients ( 16 % ) 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 1.4 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 2005 and 2012 .


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 4 , 2012 , and November 12 , 2014 .


A 12-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 86 patients randomized , 3 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 ( 5 % vs 33 % ; 21 = 11.1 ; P < .001 ; relative risk reduction ,84.7 % ) .


Long-acting injectable risperidone better controlled mean levels of hallucinations and delusions throughout follow-up ( = -0.30 ; t68 = -2.6 , P = .01 ) .


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 2 medications and the 2 psychosocial treatments .


Discontinuations owing to inadequate clinical response were more common in the oral group than in the long-acting risperidone group ( 21 = 6.1 ; P = .01 ) .


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 ( t80 = 5.3 ; P < .001 ) .


Medication adherence was associated with prevention of exacerbation and/or relapse ( 21 = 11.1 ; P = .003 ) and control of breakthrough psychotic symptoms ( = 0.2 ; t79 = 2.1 ; P = .04 ) .


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 .


clinicaltrials.gov Identifier : NCT00333177 .


Studies in HIV-1-infected infants and HIV-1-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-1 , HSV-2 and CD4 count > 250 cells/l were randomized at 34 weeks gestation to 500 mg twice-daily valacyclovir or placebo for 12 months .


Maternal CMV DNA was measured in plasma at 34 weeks gestation , in cervical secretions at 34 and 38 weeks gestation , and in breast milk at 7 postpartum timepoints ; infant CMV DNA was measured in dried blood spots at 8 timepoints including birth .


Among 148 women , 141 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 46/70 infants ( 66 % ) in placebo arm and 47/71 infants ( 66 % ) in the valacyclovir arm acquiring CMV ; median time to CMV detection did not differ .


CMV DNA was detected in 92 % of 542 breast milk specimens with no difference in CMV level between study arms .


Change in cervical shedding of CMV DNA between baseline and 38 weeks was 0.40-log greater in the placebo arm than the valacyclovir arm ( p = 0.05 ) .


In this cohort of HIV-1-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 .


ClinicalTrials.gov NCT00530777 .


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 134 dialysis facilities are randomized to receive either : ( 1 ) standard of care or `` usual '' transplant education , or ( 2 ) 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 12months ; 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 .


Clinicaltrials.gov number NCT02092727 .


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 .


199 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 .


181 patients had a successful cardioversion and 91 of the study group remained in sinus rhythm at day 30 .


Recurrence of AF was observed in 108 patients at day 30 .


An optimal cutpoint for NT-proBNP at 500 ng/L predicted recurrence of AF after cardioversion ( OR 2.94 ; 95 % CI 1.30-6 .63 ) .


In multivariate analysis adjusting for age , sex , hypertension , and treatment group strengthened the results ( OR 3,56 ; 95 % CI 1,44-8 ,81 ) .


When analysing the ROC curve of NT-proBNP in baseline and atrial fibrillation at day 30 the result was 0.57 .


NT-proBNP levels are a predictor of recurrence of AF 30 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 56 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 , 76 % with ` clinically significant apathy ' at baseline were unable to RTW versus 50 % of the patients without apathy ( p < 0.05 ) .


The Diagnostic Apathia Scale was found to have an acceptable predictive validity in terms of patients ' ability to RTW 1 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 , 35 cases in each one .


Cuanzhu ( BL 2 ) , Yuwei ( Extra ) through Yuyao ( EX-HN 4 ) , Xinming 1 ( Extra ) , Sibai ( ST 2 ) and Yintang ( GV 29 ) 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 , 10 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 77.1 % ( 27/35 ) in the observation group , which was superior to 51.4 % ( 18/35 ) in the control group ( P < 0.05 ) .


Among cured and markedly effective patients in both groups , the recurrence rate was 20.0 % ( 4/20 ) in the observation group , which was inferior to 54.5 % ( 6/11 ) in the control group ( P < 0.05 ) 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 1.5 cm H2O/L/s .


Subjects took a DI either immediately after or 30 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 30 minutes despite waning of MCh concentration over that period , measured as attenuated renarrowing when the DI was taken 30 minutes after compared with immediately after the last dose ( 7 min post-DI , -36.2 11.8 vs. 14.4 13.2 % ; 12 min post-DI , -39.5 9.8 vs. 15.2 17.8 % ) .


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 [ PRK ] ) 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 -0.75 to -3.87 diopters ( D ) and astigmatism up to -1.75 D , the first eye was randomly assigned to the application of MMC 0.02 % or a balanced salt solution for 15 seconds .


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


The study enrolled 60 patients .


In fellow eyes , the changes in the tear-film index were comparable 1 month and 6 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 1 month and 6 months .


There was a trend toward a higher asymmetry index at 1 month ; however , a statistically significant drop was observed at 6 months in the MMC group ( P < .01 ) .


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


No haze was recorded at 6 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 .


No author has a financial or proprietary interest in any material or method mentioned .


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 ( 10.231.04 vs. 10.041.49 ; p = 0.62 ) ; CCA ( 7.864.39 vs. 7.134.12 ; p = 0.57 ) ; MCD ( 8.240.89 vs. 7.581.14 ; p = 0.39 ) ; EES ( 5.432.11 vs. 4.632.30 ; p = 0.23 ) .


The composite mean score for the FTF-group was 6.85 , and for the SIV-group was 6.20 ( p < 0.05 ) .


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 20-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 60 ED patients .


Concentrations of potassium ( 4.25 vs. 4.16 mmol/L ; P = 0.031 ) , LD ( 498 vs. 459 U/L ; P = 0.039 ) and cell-free hemoglobin ( 0.42 vs. 0.22 g/L ; P = 0.042 ) were higher in samples collected with BD Vacutainer One Use Holder than with Holdex .


The mean bias of cell-free hemoglobin was -0.4 g/L in samples collected with Holdex .


Although the frequency of samples with cell-free hemoglobin > 0.5 g/L was identical ( 17/60 vs. 17/60 ; P = 1.00 ) , the frequency of those with concentrations > 3.0 g/L was higher using BD Vacutainer One Use Holder than Holdex ( 4/60 vs. 0/60 ; P = 0.042 ) .


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 ( 400mg daily ) or T-S ( 160/800mg daily ) .


Patients were followed up for 12 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 80 patients with a mean age of 53.09.3 years were prescribed N ( n = 40 ) or T-S ( n = 40 ) .


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


There were 10 episodes of infections in the N group and 9 in the T-S group ( P = 0.79 ) .


Two patients each in the N and T-S group developed SBP ( P = 0.60 ) .


There was a difference in the rate of transplantation favoring N ( P = 0.03 ) but not death .


The number of adverse events for N ( n = 7 ) and T-S ( n = 10 ) were similar ( P = 0.59 ) , with T-S being associated with an increased risk of developing a definite or probable adverse event compared to N ( 22.5 % vs 0 % , P = 0.01 ) .


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 3 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 2 incentives ( $ 10 versus $ 20 ) on these outcomes .


A 3X2 factorial , randomized controlled trial of 324 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 56.0 % to 63.3 % across privacy conditions ( p = 0.49 ) and from 52.8 % to 68.1 % across incentives ( p = 0.007 ) .


Respondents ' characteristics differed by privacy and by incentive assignments , with completely anonymous respondents and $ 20 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 13.6 % to 33.3 % across privacy conditions , with the highest estimate coming from the intermediate privacy condition ( p = 0.007 ) .


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 ST10 ( DSM 25246 ) , 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 21 and 57 y , mean 37.711.2 ) .


Subjects were then randomised into 2 groups : group A ( 13 subjects ) was given an active formulation containing 250 mg of tara gum and 1 billion viable cells of S. thermophilus ST10 , whereas group B ( 12 subjects ) was given a placebo formulation .


All the subjects participating in the study were directed to take 1 dose per day for 30 consecutive days .


The presence and concentration of exopolysaccharides ( EPSs ) in the faeces was determined at time 0 ( d0 ) , after 30 days of treatment ( d30 ) , and at the end of the 2-week follow-up period ( d45 ) .


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 2 groups at d0 , d30 , and d45 .


In the active group , supplementation with S. thermophilus ST10 and tara gum was able to significantly increase the faecal EPSs concentration compared with placebo ( from 0.169 mg/g to 0.633 mg/g after 30 d , P < 0.001 ) .


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


The L/M ratio diminished from 0.021 in the active group to 0.014 and 0.015 after 30 and 45 days , respectively ( P = 0.045 and P = 0.033 compared with placebo ) .


The sucralose concentration decreased from 35.8 mg to 27.9 mg and 29.1 mg ( P = 0.038 and P = 0.026 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 30 days or at the end of the follow-up .


The association of the EPSs produced by S. thermophilus ST10 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 .


40 patients with schizophrenia-spectrum disorders and 40 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 = 180 ) 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 1-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 2 hamstring muscle injuries .


Randomized controlled trial ; Level of evidence , 2 .


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 = .02 ) .


The mean time to return to play was 26.7 7.0 days and 42.5 20.6 days for the PRP and control groups , respectively ( t ( 22 ) = 2.50 , P = .02 ) .


[ corrected ] .


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 2 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-3 fatty acids can reduce inflammation systemically and may be beneficial to the airways .


To determine if omega-3 fatty acid supplementation via fish oil would mitigate the airway inflammatory response induced by a single HFM .


Seventeen non-asthmatic men ( 22 2 years . )


were supplemented with 3,000 mg day ( -1 ) fish oil or a placebo for 3 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 2 h following a HFM .


Following a HFM , triglycerides increased in both fish oil and placebo groups compared to pre-HFM ( ~ 59 and ~ 49 % , respectively , p < 0.05 ) .


The percent increase in FENO was greater in the placebo group compared to the fish oil group ( 25.7 16.7 vs. -1.99 10.5 % , respectively , p < 0.05 ) .


A significant correlation was observed between blood triglycerides and FENO in the placebo group ( r = 0.61 ; p < 0.05 ) , but not the fish oil group ( p = 0.21 ) .


A single HFM increases airway inflammation and omega-3 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 HER2-positive breast cancer .


We therefore aimed to assess the efficacy of the addition of carboplatin to neoadjuvant therapy for triple-negative and HER2-positive breast cancer .


Patients with previously untreated , non-metastatic , stage II-III , triple-negative breast cancer and HER2-positive breast cancer were enrolled .


Patients were treated for 18 weeks with paclitaxel ( 80 mg/m ( 2 ) once a week ) and non-pegylated liposomal doxorubicin ( 20 mg/m ( 2 ) once a week ) .


Patients with triple-negative breast cancer received simultaneous bevacizumab ( 15 mg/kg intravenously every 3 weeks ) .


Patients with HER2-positive disease received simultaneous trastuzumab ( 8 mg/kg initial dose with subsequent doses of 6 mg/kg intravenously every 3 weeks ) and lapatinib ( 750 mg daily ) .


Patients were randomly assigned in a 1:1 ratio with dynamic allocation and minimisation , stratified by biological subtype and Ki-67 level to receive , at the same time as the backbone regimens , either carboplatin ( AUC 15 [ 20 for the first 329 patients ] once a week ) or no carboplatin .


The primary endpoint the proportion of patients who achieved a pathological complete response ( defined as ypT0 ypN0 ) , analysed for all patients who started treatment ; a p value of less than 02 was deemed significant for the primary endpoint .


This trial is registered with ClinicalTrials.gov , number NCT01426880 .


296 patients were randomly assigned to receive carboplatin and 299 to no additional carboplatin , of whom 295 and 293 started treatment , respectively .


In this final analysis , 129 patients ( 437 % , 95 % CI 381-494 ) in the carboplatin group achieved a pathological complete response , compared with 108 patients ( 369 % , 313-424 ) without carboplatin ( odds ratio 133 , 95 % CI 096-185 ; p = 0107 ) .


Of the patients with triple-negative breast cancer , 84 ( 532 % , 544-609 ) of 158 patients achieved a pathological complete response with carboplatin , compared with 58 ( 369 % , 294-445 ) of 157 without ( p = 0005 ) .


Of the patients with HER2-positive tumours , 45 ( 328 % , 250-407 ) of 137 patients achieved a pathological complete response with carboplatin compared with 50 ( 368 % , 287-449 ) of 136 without ( p = 0581 ; test for interaction p = 0015 ) .


Haematological and non-haematological toxic effects that were significantly more common in the carboplatin group than in the no-carboplatin group included grade 3 or 4 neutropenia ( 192 [ 65 % ] vs 79 [ 27 % ] ) , grade 3 or 4 anaemia ( 45 [ 15 % ] vs one [ < 1 % ] ) , grade 3 or 4 thrombocytopenia ( 42 [ 14 % ] vs one [ < 1 % ] ) , and grade 3 or 4 diarrhoea ( 51 [ 17 % ] vs 32 [ 11 % ] ) ; carboplatin was more often associated with dose discontinuations ( 141 [ 48 % ] with carboplatin and 114 [ 39 % ] without carboplatin ; p = 0031 ) .


The frequency of grade 3 or 4 haematological events decreased from 82 % ( n = 135 ) to 70 % ( n = 92 ) and grade 3 or 4 non-haematological events from 78 % ( n = 128 ) to 59 % ( n = 77 ) in the carboplatin arm when the dose of carboplatin was reduced from AUC 20 to 15 .


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 HER2-positive breast cancer .


GlaxoSmithKline , Roche , and Teva .


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 = 1079 ) , metformin ( n = 1073 ) or placebo ( n = 1082 ) for an average of 3years , 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 1 , 5 , 6 and 9years 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 9years after randomization and lower intakes of red meat and sweets were maintained for up to 5years .


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 9years .


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 300 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 2 to 4 ( post-bronchodilator FEV1/FVC < 0.7 and FEV1 < 80 % of predicted ) , who receive reimbursement by health insurance companies for physical therapy ( post-bronchodilator Tiffeneau-index < 0.6 ) and who experience a COPD exacerbation will be asked within 56 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 3 and 6 weeks , 3 , 6 , 12 and 24 months after inclusion .


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


The Netherlands National Trial Register NTR1972 .


An imbalance between Th1 and Th2 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-33 , 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 5 weeks .


The primary end point was the improvement in Rhinitis Quality of Life ( RQLQ ) global score at the fifth week of LP-33 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 425 subjects were included .


Using intent-to-treat analysis , the RQLQ global score decreased significantly more in the LP-33 group than in the placebo group ( P = 0.0255 , difference = -0.286 ( 95 % confidence interval ( CI ) : -0.536 ; -0.035 ) ) .


No significant differences were noted for the change of the rhinitis total symptom score 5 global score between groups ( P = 0.1288 , difference = -0.452 ( 95 % CI : -1.036 ; 0.132 ) ) .


Significant differences in ocular symptoms ( RQLQ ) were observed between groups ( P = 0.0029 , difference = -0.4087 ( 95 % CI : -0.6768 ; -0.1407 ) ) .


This study performed by GPs shows that LP-33 improves the quality of life of subjects with persistent AR who are currently being treated with an oral H1-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 3 trial used a 2-stage design .


Both stages included 2-week screening , 4-week placebo-controlled treatment , and 20-week placebo-free ( open-label ) extension phases .


In stage I , 196 HIV-seropositive patients with chronic diarrhea were randomized to crofelemer 125 mg , 250 mg , or 500 mg or placebo twice daily .


Using a prospective analysis , the 125-mg twice-daily dose was selected for stage II .


In stage II , 180 new patients were randomized to crofelemer 125 mg twice daily or placebo for 4 weeks .


Primary efficacy analysis was the percentage of patients ( stages I/II combined ) who achieved clinical response ( defined as 2 watery stools/week during 2 of 4 weeks ) .


During the placebo-free extension phase , response ( 2 watery stools ) was assessed weekly .


Significantly more patients receiving crofelemer 125 mg achieved clinical response versus placebo ( 17.6 % vs 8.0 % ; one-sided , P = .01 ) .


Crofelemer 125 mg resulted in a greater change from baseline in number of daily watery bowel movements ( P = .04 ) and daily stool consistency score ( P = .02 ) versus placebo .


During the placebo-free extension phase , percentages of weekly responders ranged from 40 % to 56 % at weeks 11 to 24 .


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 .


66 adult , ASA physical status 1 and 2 patients , aged 25 to 65 years , undergoing elective abdominal surgery .


Patients were randomized to 4 groups : the epidural saline control group ( Group C ; L2-L3 puncture , epidural and IV saline ) , the IV lidocaine group ( Group IV ; L2-L3 puncture , saline epidural , IV lidocaine 1 mg/kg ) , the lumbar epidural lidocaine group ( Group EL ; L2-L3 puncture , 1.5 % lidocaine epidural , IV saline ) , and the thoracic epidural lidocaine group ( Group ET ; T9-T10 puncture , 1.5 % 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 60 , the plasma concentration of lidocaine at induction , and the occurrence of adverse events .


The induction time ( when BIS reached 60 ) also was recorded .


The induction propofol dose , Ce , and plasma concentration of propofol when BIS equaled 60 were significantly lower in Group IV , Group EL , and Group ET than Group C.


The above parameters in Group ET ( T9 - T10 puncture ) were significantly less than in Group EL ( L2 - L3 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 2 diabetes ( T2D ) and its response to changes in insulin sensitivity .


The circulating miRNA profile was assessed in a pilot study of 12 men : 6 with normal glucose tolerance ( NGT ) and 6 T2D patients .


The association of 10 circulating miRNAs with T2D was cross-sectionally validated in an extended sample of 45 NGT vs. 48 T2D subjects ( 65 nonobese and 28 obese men ) and longitudinally in 35 T2D patients who were recruited in a randomized , double-blinded , and placebo-controlled 3-month trial of metformin treatment .


Circulating miRNAs were also measured in seven healthy volunteers before and after a 6-h hyperinsulinemic-euglycemic clamp and insulin plus intralipid/heparin infusion .


Cross-sectional studies disclosed a marked increase of miR-140-5p , miR-142-3p , and miR-222 and decreased miR-423-5p , miR-125b , miR-192 , miR-195 , miR-130b , miR-532-5p , and miR-126 in T2D patients .


Multiple linear regression analyses revealed that miR-140-5p and miR-423-5p contributed independently to explain 49.5 % ( P < 0.0001 ) of fasting glucose variance after controlling for confounders .


A discriminant function of four miRNAs ( miR-140-5p , miR-423-5p , miR-195 , and miR-126 ) was specific for T2D with an accuracy of 89.2 % ( P < 0.0001 ) .


Metformin ( but not placebo ) led to significant changes in circulating miR-192 ( 49.5 % ; P = 0.022 ) , miR-140-5p ( -15.8 % ; P = 0.004 ) , and miR-222 ( -47.2 % ; P = 0.03 ) , in parallel to decreased fasting glucose and HbA1c .


Furthermore , while insulin infusion during clamp decreased miR-222 ( -62 % ; P = 0.002 ) , the intralipid/heparin mixture increased circulating miR-222 ( 163 % ; P = 0.015 ) and miR-140-5p ( 67.5 % ; P = 0.05 ) .


This study depicts the close association between variations in circulating miRNAs and T2D and their potential relevance in insulin sensitivity .


Previous studies indicated that a single session of repeated-slip exposure can reduce over 40 % 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 ( 65 years old ) were randomly assigned to either the training group ( N = 109 ) , who then were exposed to 24 unannounced repeated slips , or the control group ( N = 103 ) , 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 12 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 50 % ( from 34 % to 15 % , p < .05 ) .


Those who experienced merely a single slip were 2.3 times more likely to fall during the same 12-month follow-up period ( p < .05 ) than those who experienced the 24 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 5mg and risperidone 2.5 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 D2 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/ct2/show/NCT01259973 ) .


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 18 - to 74-year-old people with hypertension or high-normal blood pressure .


This study will assess the effectiveness of a 12-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 1year 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 .


Current Controlled Trials ISRCTN71952900 ( 7 June 2013 ) .


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 2,263 patients enrolled in the SUpplementation with FOLate , vitamins B-6 and B-12 and/or OMega-3 fatty acids randomized controlled trial .


Incident major cardiovascular , cardiac and cerebrovascular events were ascertained during the 4.7 years of follow up .


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


During the follow-up , 154 , 379 and 84 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 < 0.002 ) , total omega 3 polyunsaturated fatty acids ( P trend < 0.03 ) , docosapentaenoic acid ( P trend < 0.019 ) , docosahexaenoic acid ( P trend < 0.004 ) , eicosapentaenoic acid + docosahexaenoic acid ( P trend < 0.03 ) and eicosapentaenoic acid + docosapentaenoic acid + docosahexaenoic acid ( P trend < 0.02 ) .


This inverse association was borderline significant with increased quartiles of stearidonic acid ( P trend < 0.06 ) .


In the full model , only stearidonic acid remained inversely associated with the risk of developing a major cardiovascular event ( P trend < 0.035 ) , a cardiac event ( P trend < 0.016 ) or a cerebrovascular event ( P trend < 0.014 ) , while arachidonic acid was inversely associated with the risk a cerebrovascular event ( P trend < 0.033 ) .


The inverse association of long chain omega 3 polyunsaturated fatty acids with recurrence of Cardiovascular diseases was mainly driven by well-known cardiovascular risk factors .


Controlled-Trials .


com ISRCTN41926726 .


Evaluate the pharmacokinetics ( PK ) , safety , and tolerability of single doses of once-daily USL255 , 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 USL255 from 25-1 ,400 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 [ % CV ] ) 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 USL255 25-1 ,400 mg , plasma topiramate concentration-time profiles were flat up to 24 h after dosing .


AUC was dose proportional from 25-1 ,400 mg , and Cmax was dose proportional from 50-1 ,400 mg ; both AUC and Cmax were linear across the entire dose range .


Low intersubject and intrasubject % CV values were observed for AUC0-t , AUC0 - , and Cmax ( intersubject % CV : 20.2 , 19.6 , and 22.4 % , respectively ; intrasubject % CV of dose-normalized mean values : 10.8 , 8.2 , and 13.2 % , respectively ) .


USL255 was generally safe and well tolerated with MTD established at 1,200 mg .


These results demonstrate that USL255 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 USL255 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 16 years of age who were undergoing nonemergency cardiac surgery were recruited from 17 centers in the United Kingdom .


Patients with a postoperative hemoglobin level of less than 9 g per deciliter were randomly assigned to a restrictive transfusion threshold ( hemoglobin level < 7.5 g per deciliter ) or a liberal transfusion threshold ( hemoglobin level < 9 g per deciliter ) .


The primary outcome was a serious infection ( sepsis or wound infection ) or an ischemic event ( permanent stroke [ confirmation on brain imaging and deficit in motor , sensory , or coordination functions ] , myocardial infarction , infarction of the gut , or acute kidney injury ) within 3 months after randomization .


Health care costs , excluding the index surgery , were estimated from the day of surgery to 3 months after surgery .


A total of 2007 patients underwent randomization ; 4 participants withdrew , leaving 1000 in the restrictive-threshold group and 1003 in the liberal-threshold group .


Transfusion rates after randomization were 53.4 % and 92.2 % in the two groups , respectively .


The primary outcome occurred in 35.1 % of the patients in the restrictive-threshold group and 33.0 % of the patients in the liberal-threshold group ( odds ratio , 1.11 ; 95 % confidence interval [ CI ] , 0.91 to 1.34 ; P = 0.30 ) ; there was no indication of heterogeneity according to subgroup .


There were more deaths in the restrictive-threshold group than in the liberal-threshold group ( 4.2 % vs. 2.6 % ; hazard ratio , 1.64 ; 95 % CI , 1.00 to 2.67 ; P = 0.045 ) .


Serious postoperative complications , excluding primary-outcome events , occurred in 35.7 % of participants in the restrictive-threshold group and 34.2 % 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 , ISRCTN70923932 . )


To compare the efficacy differences between acupuncture at Zhibian ( BL 54 ) through Shuidao ( ST 28 ) and regular acupuncture for polycystic ovary syndrome .


One hundred and one patients , by using random digital table , were randomly divided into an observation group ( 49 cases ) and a control group ( 52 cases ) .


Patients in the observation group were treated with acupuncture at Zhibian ( BL 54 ) through Shuidao ( ST 28 ) as main acupoints , and accompanied acupoints were selected according to syndrome differentiation .


Elongated needles ( 175 mm in length ) were inserted at Zhibian ( BL 54 ) with an angle of 200 with sagittal plane .


The insertion depth was 100-115 mm , reaching Shuidao ( ST 28 ) 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 , 15 times as one session , and 5 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 65.3 % ( 32/49 ) and the effective rate was 91.8 % ( 45/49 ) in the observation group after treatment , which was significantly superior to 48.1 % ( 25/52 ) and 63.5 % ( 33/52 ) in the control group ( both P < 0.01 ) .


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 < 0.05 ) .


After treatment , the follicle-stimulating hormone ( FSH ) , luteinizing hormone ( LH ) , LH/FSH , testos terone ( T ) were significantly reduced in the observation group ( P < 0.01 , P < 0.05 ) ; the LH and T were also apparently reduced in the control group ( P < .01 , P < 0.05 ) .


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 < 0.05 , P < 0.01 ) .


Acuouncture at Zhibian ( BL 54 ) through Shuidao ( ST 28 ) 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 9,457 men 55 years old or older at randomization to the placebo arm of PCPT ( Prostate Cancer Prevention Trial ) .


The men reported new use of medications quarterly .