Magnetic resonance imaging ( MRI ) and TTE images were retrospectively reviewed in 40 consecutive patients with pulmonary hypertension .


RV and left ventricular volumes and ejection fractions were calculated using MRI .


TTE areas and indices of RV ejection fraction ( RVEF ) were compared .


The average age was 42 12 years , with a majority of women ( 85 % ) .


There was a wide range of mean pulmonary arterial pressures ( 27-81 mm Hg ) and RV end-diastolic volumes ( 111-576 mL ) , RVEFs ( 8 % -67 % ) , and left ventricular ejection fractions ( 26 % -72 % ) by MRI .


There was a strong association between TTE and MRI-derived parameters : RV end-diastolic area ( by TTE imaging ) and RV end-diastolic volume ( by MRI ) , R ( 2 ) = 0.78 ( P < .001 ) ; RV fractional area change by TTE imaging and RVEF by MRI , R ( 2 ) = 0.76 ( P < .001 ) ; and tricuspid annular plane systolic excursion by TTE imaging and RVEF by MRI , R ( 2 ) = 0.64 ( P < .001 ) .


By receiver operating characteristic curve analysis , an RV fractional area change < 25 % provided excellent discrimination of moderate systolic dysfunction ( RVEF < 35 % ) , with an area under the curve of 0.97 ( P < .001 ) .


An RV end-diastolic area index of 18cm ( 2 ) / m ( 2 ) provided excellent discrimination for moderate RV enlargement ( area under the curve , 0.89 ; P < .001 ) .


Echocardiographic estimates of RV volume ( by RV end-diastolic area ) and function ( by RV fractional area change and tricuspid annular plane systolic excursion ) offer good approximations of RV size and function in patients with pulmonary hypertension and allow the accurate discrimination of normal from abnormal .


Previous studies have focused on the effect of food advertisements on the caloric intake of children .


However , the role of individual susceptibility in this effect is unclear .


The aim of this study was to examine the role of impulsivity in the effect of advergames that promote energy-dense snacks on children 's snack intake .


First , impulsivity scores were assessed with a computer task .


Then a randomized between-subject design was conducted with 261 children aged 7 to 10 years who played an advergame promoting either energy-dense snacks or nonfood products .


As an extra manipulation , half of the children in each condition were rewarded for refraining from eating , the other half were not .


Children could eat freely while playing the game .


Food intake was measured .


The children then completed questionnaire measures , and were weighed and measured .


Overall , playing an advergame containing food cues increased general caloric intake .


Furthermore , rewarding children to refrain from eating decreased their caloric intake .


Finally , rewarding impulsive children to refrain from eating had no influence when they were playing an advergame promoting energy-dense snacks , whereas it did lead to reduced intake among low impulsive children and children who played nonfood advergames .


Playing an advergame promoting energy-dense snacks contributes to increased caloric intake in children .


The advergame promoting energy-dense snacks overruled the inhibition task to refrain from eating among impulsive children , making it more difficult for them to refrain from eating .


The findings suggest that impulsivity plays an important role in susceptibility to food advertisements .


The EVEREST II ( Endovascular Valve Edge-to-Edge REpair STudy ) High-Risk registry and REALISM Continued Access Study High-Risk Arm are prospective registries of patients who received the MitraClip device ( Abbott Vascular , Santa Clara , California ) for mitral regurgitation ( MR ) in the United States .


The purpose of this study was to report 12-month outcomes in high-risk patients treated with the percutaneous mitral valve edge-to-edge repair .


Patients with grades 3 to 4 + MR and a surgical mortality risk of 12 % , based on the Society of Thoracic Surgeons risk calculator or the estimate of a surgeon coinvestigator following pre-specified protocol criteria , were enrolled .


In the studies , 327 of 351 patients completed 12 months of follow-up .


Patients were elderly ( 76 11 years of age ) , with 70 % having functional MR and 60 % having prior cardiac surgery .


The mitral valve device reduced MR to 2 + in 86 % of patients at discharge ( n = 325 ; p < 0.0001 ) .


Major adverse events at 30 days included death in 4.8 % , myocardial infarction in 1.1 % , and stroke in 2.6 % .


At 12 months , MR was 2 + in 84 % of patients ( n = 225 ; p < 0.0001 ) .


From baseline to 12 months , left ventricular ( LV ) end-diastolic volume improved from 161 56 ml to 143 53 ml ( n = 203 ; p < 0.0001 ) and LV end-systolic volume improved from 87 47 ml to 79 44 ml ( n = 202 ; p < 0.0001 ) .


New York Heart Association functional class improved from 82 % in class III/IV at baseline to 83 % in class I/II at 12 months ( n = 234 ; p < 0.0001 ) .


The 36-item Short Form Health Survey physical and mental quality-of-life scores improved from baseline to 12 months ( n = 191 ; p < 0.0001 ) .


Annual hospitalization rate for heart failure fell from 0.79 % pre-procedure to 0.41 % post-procedure ( n = 338 ; p < 0.0001 ) .


Kaplan-Meier survival estimate at 12 months was 77.2 % .


The percutaneous mitral valve device significantly reduced MR , improved clinical symptoms , and decreased LV dimensions at 12 months in this high-surgical-risk cohort .


( Endovascular Valve Edge-to-Edge REpair STudy [ EVERESTIIRCT ] ; NCT00209274 ) .


The aim of this study was to compare health-related quality of life ( HRQoL ) scores obtained from the instrument Short Form ( SF ) -36 through the so-called SF-6D utilities , and those obtained from 15D , in patients with ST-elevation myocardial infarction ( STEMI ) , and to evaluate the consequences in estimation of quality adjusted life years ( QALYs ) .


This was a sub-study of the Norwegian District Treatment of STEMI , in which patients with STEMI treated with tenecteplase , were randomized to early angioplasty or standard management ( n = 266 ) .


HRQoL data were collected at all visits ( 0 , 1 , 3 , 7 and 12 months ) .


All patients with complete data were included ( n = 248 ) .


The score range was 0.33-1 .0 for SF-6D and 0.49-1 .0 for 15D .


Mean utility scores from 15D were higher and had different distribution compared to scores from SF-6D .


Mean QALY for the whole group was higher using 15D than SF-6D ( 0.89 vs. 0.77 ) .


The incremental number of QALYs with early angioplasty compared to standard treatment was 0.005 ( 95 % CI : - 0.018 to 0.028 ) using SF-6D , and 0.004 ( 95 % CI : - 0.010 to 0.018 ) using the 15D instrument .


Choice of instrument may influence HRQoL scores , but not necessarily the gain in QALYs .


Post-thrombotic syndrome ( PTS ) is a common and burdensome complication of deep venous thrombosis ( DVT ) .


Previous trials suggesting benefit of elastic compression stockings ( ECS ) to prevent PTS were small , single-centre studies without placebo control .


We aimed to assess the efficacy of ECS , compared with placebo stockings , for the prevention of PTS .


We did a multicentre randomised placebo-controlled trial of active versus placebo ECS used for 2 years to prevent PTS after a first proximal DVT in centres in Canada and the USA .


Patients were randomly assigned to study groups with a web-based randomisation system .


Patients presenting with a first symptomatic , proximal DVT were potentially eligible to participate .


They were excluded if the use of compression stockings was contraindicated , they had an expected lifespan of less than 6 months , geographical inaccessibility precluded return for follow-up visits , they were unable to apply stockings , or they received thrombolytic therapy for the initial treatment of acute DVT .


The primary outcome was PTS diagnosed at 6 months or later using Ginsberg 's criteria ( leg pain and swelling of 1 month duration ) .


We used a modified intention to treat Cox regression analysis , supplemented by a prespecified per-protocol analysis of patients who reported frequent use of their allocated treatment .


This study is registered with ClinicalTrials.gov , number NCT00143598 , and Current Controlled Trials , number ISRCTN71334751 .


From 2004 to 2010 , 410 patients were randomly assigned to receive active ECS and 396 placebo ECS .


The cumulative incidence of PTS was 142 % in active ECS versus 127 % in placebo ECS ( hazard ratio adjusted for centre 113 , 95 % CI 073-176 ; p = 058 ) .


Results were similar in a prespecified per-protocol analysis of patients who reported frequent use of stockings .


ECS did not prevent PTS after a first proximal DVT , hence our findings do not support routine wearing of ECS after DVT .


Canadian Institutes of Health Research .


The results of SYNTAX trial have been reported based on `` corelab '' calculated SS ( cSS ) .


It has been shown that reproducibility of SS is better among the core laboratory technicians than interventional cardiologists .


Thus , the prognostic value and clinical implication of the `` site '' SYNTAX SS ( sSS ) remain unknown .


The study sought to evaluate the prognostic value and clinical implication of the sSS after percutaneous coronary intervention ( PCI ) or coronary artery bypass graft ( CABG ) surgery in the randomized SYNTAX trial .


The sSS was calculated by the site investigators before randomization in the SYNTAX trial .


New tertiles based on the sSS were defined with low ( 0 to 19 ) , intermediate ( 20 to 27 ) , and high ( 28 ) scores .


The clinical endpoints were compared between PCI and CABG by Kaplan-Meier estimates , log-rank comparison , and Cox regression analyses using the new tertiles .


The sSS-based SS II was calculated and its predictive performance was evaluated .


The mean difference in cSS and sSS is 3.8 11.2 , with a mean absolute difference of 8.9 7.8 .


In the overall cohort , using sSS there was a higher incidence of major adverse cardiac and cerebrovascular events ( MACCE ) at 5-year follow-up in the PCI group for low ( 31.9 % vs. 24.5 % ; p = 0.054 ) , intermediate ( 39.5 % vs. 29.5 % ; p = 0.019 ) , and high ( 43.0 % vs. 31.4 % ; p = 0.003 ) tertiles , compared with the CABG group .


Similarly , in the 3-vessel disease subgroup , 5-year MACCE rates were higher in PCI group in all tertiles .


Conversely , in the left main subgroup , MACCE rates were similar for PCI and CABG groups in all tertiles .


The sSS-based SS II ( c-index : 0.736 ) had predictive performance similar to the cSS-based SS II ( c-index : 0.744 ) , with net reclassification index of -0.0062 ( p = 0.79 ) .


Appropriate training and unbiased assessment are needed when using SS in clinical decision making .


sSS and tertiles based on sSS showed poor discrimination among low , intermediate , and high-risk groups .


However , combining clinical factors with sSS retained the predictive performance of SS II .


( SYNTAX Study : TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries ; NCT00114972 ) .


Epidemiologic evidence has suggested that diets with a high ratio of palmitic acid ( PA ) to oleic acid ( OA ) increase risk of cardiovascular disease ( CVD ) .


To gain additional insights into the relative effect of dietary fatty acids and their metabolism on CVD risk , we sought to identify a metabolomic signature that tracks with diet-induced changes in blood lipid concentrations and whole-body fat oxidation .


We applied comprehensive metabolomic profiling tools to biological specimens collected from 18 healthy adults enrolled in a crossover trial that compared a 3-wk high-palmitic acid ( HPA ) with a low-palmitic acid and high-oleic acid ( HOA ) diet .


A principal components analysis of the data set including 329 variables measured in 15 subjects in the fasted state identified one factor , the principal components analysis factor in the fasted state ( PCF1-Fasted ) , which was heavily weighted by the PA : OA ratio of serum and muscle lipids , that was affected by diet ( P < 0.0001 ; HPA greater than HOA ) .


One other factor , the additional principal components analysis factor in the fasted state ( PCF2-Fasted ) , reflected a wide range of acylcarnitines and was affected by diet in women only ( P = 0.0198 ; HPA greater than HOA ) .


HOA lowered the ratio of serum low-density lipoprotein to high-density lipoprotein ( LDL : HDL ) in men and women , and adjustment for the PCF1-Fasted abolished the effect .


In women only , adjustment for the PCF2-Fasted eliminated the HOA-diet effect on serum total - and LDL-cholesterol concentrations .


The respiratory exchange ratio in the fasted state was lower with the HPA diet ( P = 0.04 ) , and the diet effect was eliminated after adjustment for the PCF1-Fasted .


The messenger RNA expression of the cholesterol regulatory gene insulin-induced gene-1 was higher with the HOA diet ( P = 0.008 ) .


These results suggest that replacing dietary PA with OA reduces the blood LDL concentration and whole-body fat oxidation by modifying the saturation index of circulating and tissue lipids .


In women , these effects are also associated with a higher production and accumulation of acylcarnitines , possibly reflecting a shift in fat catabolism .


To observe the effect of qi benefiting stasis removing method ( QBSRM ) on systemic inflammatory response and coagulation function in multiple organ dysfunction syndrome ( MODS ) patients .


Totally 40 MODS patients who were admitted to Affiliated Hospital of Nanjing University of Traditional Chinese Medicine between May 2010 to December 2011 were randomly assigned to two groups , the experimental group ( 21 cases ) and the control group ( 19 cases ) .


Patients in the control group were treated with routine Western therapy , while those in the experimental group additionally took decoction for benefiting qi removing stasis .


Inflammatory factors ( including interleukin-1 , interleukin-6 , tumor necrosis factor-alpha ) and coagulation parameters [ including prothrombin time ( PT ) , activated partial thromboplastin time ( APTT ) , fibrinogen ( FIB ) , and D-dimer ( DD ) ] were observed before treatment , and 3 , 7 , and 14 days after treatment in the two groups .


At day 7 after treatment , levels of interleukin-1 , interleukin-6 , and PT were significantly lower in the experimental group than in the control group ( P < 0.05 ) .


At day 14 after treatment , tumor necrosis factor-x and DD were significantly lower in the experimental group than in the control group ( P < 0.05 ) .


There was no statistical difference in APTT or FIB at day 3 , 7 and 14 after treatment ( P > 0.05 ) .


QBSRM could relieve systemic inflammatory response and improve coagulation functions .


We previously found that the use of ezetimibe increased rapidly with different patterns between the United States ( US ) and Canada prior to the landmark Ezetimibe and Simvastatin in Hypercholesterolemia Enhance Atherosclerosis Regression ( ENHANCE ) trial , which was reported in January 2008 , and failed to show that the drug slowed the progression of atherosclerosis .


What is not known is how practice in the 2 countries changed after the ENHANCE trial .


We examined ezetimibe use trends in the US and Canada before and after the reporting of the ENHANCE trial .


We conducted a population-based , retrospective , time-series analysis using the data collected by IMS Health in the US and CompuScript in Canada from January 1 , 2002 , to December 31 , 2009 .


The main outcome measure was monthly number of prescriptions for ezetimibe-containing products .


The monthly number of ezetimibe prescriptions/100 ,000 population rose from 6 to 1,082 in the US from November 2002 to January 2008 , then significantly declined to 572/100 ,000 population by December 2009 after the release of the ENHANCE trial , a decrease of 47.1 % ( P < .001 ) .


In contrast , in Canada , use continuously rose from 2 to 495/100 ,000 population from June 2003 to December 2009 ( P = .2 ) .


United States expenditures totaled $ 2.24 billion in 2009 .


Ezetimibe remains commonly used in both the US and Canada .


Ezetimibe use has decreased in the US post-ENHANCE , whereas use has gradually but steadily increased in Canada .


The diverging patterns of ezetimibe use in the US and Canada require further investigation , as they reveal that a common evidence base is eliciting very different utilization patterns in neighboring countries .


To compare mean heart and left anterior descending coronary artery ( LAD ) doses ( NTDmean ) and positional reproducibility in larger-breasted women receiving left breast radiotherapy using supine voluntary deep-inspiratory breath-hold ( VBH ) and free-breathing prone techniques .


Following surgery for early breast cancer , patients with estimated breast volumes > 750 cm ( 3 ) underwent planning-CT scans in supine VBH and free-breathing prone positions .


Radiotherapy treatment plans were prepared , and mean heart and LAD doses were calculated .


Patients were randomised to receive one technique for fractions 1-7 , before switching techniques for fractions 8-15 ( 40 Gy/15 fractions total ) .


Daily electronic portal imaging and alternate-day cone-beam CT ( CBCT ) imaging were performed .


The primary endpoint was the difference in mean LAD NTDmean between techniques .


Population systematic ( ) and random errors ( ) were estimated .


Within-patient comparisons between techniques used Wilcoxon signed-rank tests .


34 patients were recruited , with complete dosimetric data available for 28 .


Mean heart and LAD NTDmean doses for VBH and prone treatments respectively were 0.4 and 0.7 ( p < 0.001 ) and 2.9 and 7.8 ( p < 0.001 ) .


Clip-based CBCT errors for VBH and prone respectively were 3.0 mm and 6.5 mm ( ) and 3.5 mm and 5.4 mm ( ) .


In larger-breasted women , supine VBH provided superior cardiac sparing and reproducibility than a free-breathing prone position .


Depression is common in diabetes and linked to adverse health outcomes .


This study evaluated the efficacy of a guided web-based intervention in reducing depression in adults with type 1 and type 2 diabetes .


A total of 260 participants with diabetes and elevated depressive symptoms ( Center for Epidemiologic Studies Depression Scale [ CES-D 23 ] ) were randomly assigned to the GET.ON Mood Enhancer Diabetes ( a guided self-help intervention , n = 130 ) or a brief online unguided psychoeducation program for depression ( n = 130 ) .


The primary outcome was depressive symptoms severity ( CES-D ) .


The secondary outcomes included diabetes-specific emotional distress ( Problem Areas in Diabetes [ PAID ] scale ) and participant satisfaction ( adaption CSQ-8 ) .


Data were collected at baseline and 2 months after randomization .


To identify differences in outcome between the groups , we used analyses of covariance with the baseline CES-D score as covariate on both intent-to-treat ( ITT ) and per-protocol ( PP ) basis .


Compared with the control group , the intervention group showed significantly less depressive symptom severity at posttreatment based on ITT ( d = 0.89 ) and PP analyses ( d = 1.00 ) .


The intervention participants displayed a significantly larger reduction in diabetes-specific emotional distress ( d = 0.58 , ITT ) .


The intervention appeared to be acceptable to the participants ; 95 % ( n = 121 ) would recommend the training to a friend with diabetes in need of psychological help .


A guided , web-based intervention to reduce depression in adults with type 1 and type 2 diabetes is effective in reducing both depressive symptoms and diabetes-specific emotional distress .


Dietary sodium influences intermediate physiological traits in healthy adults independent of changes in blood pressure .


The purpose of this study was to test the hypothesis that dietary sodium affects cardiac autonomic modulation during mental stress .


In a prospective , randomized cross-over design separated by 1 month between diets , 70 normotensive healthy young adults ( F/M : 44/26 , aged 18-38 years ) consumed a 5-day low ( 10 mmol/day ) , normal ( 150 mmol ) , and high ( 400 mmol ) sodium diet followed by heart rate variability ( HRV ) recordings at rest and during 5-min computerized mental arithmetic .


Women were studied in the low hormone phase of the menstrual cycle following each diet .


Diet did not affect resting blood pressure , but heart rate ( HR ) ( mean SE ) was 66 1 , 64 1 , and 63 1 bpm in low , normal , and high sodium conditions , respectively ( analysis of variance P = 0.02 ) .


For HRV , there was a main effect of sodium on resting SD of normalized RR intervals ( SDNN ) , square root of the mean squared difference of successive normalized RR intervals ( RMSSD ) , high frequency , low-frequency normalized units ( LFnu ) , and high-frequency normalized units ( HFnu ) ( P < 0.01 for all ) .


The response to low sodium was most marked and consistent with sympathetic activation and reduced vagal activity , with increased LFnu and decreased SDNN , RMSSD , and HFnu compared to both normal and high sodium conditions ( P 0.05 for all ) .


Dietary sodium-by-mental stress interactions were significant for mean NN , RMSSD , high-frequency power , LFnu , and low frequency/high frequency ratio ( P < 0.05 for all ) .


The interactions signify that sodium restriction evoked an increase in resting sympathetic activity and reduced vagal activity to the extent that mental stress caused modest additional disruptions in autonomic balance .


Conversely , normal and high sodium evoked a reduction in resting sympathetic activity and incremental increase in resting vagal activity , which were disrupted to a greater extent during mental stress compared to low sodium .


We conclude that autonomic control of HRV at rest and during mental stress is altered by dietary sodium in healthy normotensive young adult men and women .


Beta-palmitate ( sn-2 palmitate ) mimics human milk fat , enabling easier digestion.Therefore , we hypothesized that infants consuming high beta-palmitate formula would have more frequent , softer stools and reduced crying compared to infants consuming low beta-palmitate formula .


Formula-fed infants were randomly assigned to receive either ( 1 ) formula with high beta-palmitate ( HBP , n = 21 ) or ( 2 ) regular formula with a standard vegetable oil mix ( LBP , n = 21 ) .


A matched group of breastfed infants served as a reference ( BF , n = 21 ) .


Crying and stool characteristics data were recorded by the parents for 3 days before the 6 - and 12-week visits .


We found no significant differences in the stool frequency or consistency between the two formula groups .


The percentage of crying infants in the LBP group was significantly higher than that in the HBP and BF groups during the evening at 6 weeks ( 88.2 % vs. 56.3 % and 55.6 % , p < 0.05 ) and during the afternoon at 12 weeks ( 91.7 % vs. 50.0 % and 40 % , p < 0.05 ) .


The infants fed HBP had significantly shorter crying durations when compared with infants fed LBP formula ( 14.90 3.85 vs. 63.96 21.76 min/day , respectively ; p = 0.047 ) .


Our study indicates that consumption of a high beta-palmitate formula affects infant crying patterns during the first weeks of life .


Comparable to breastfeeding , it reduced crying duration and frequency , primarily during the afternoon and evening hours , thereby improving the well-being of formula-fed infants and their parents .


NCT00874068.Registration date March 31 , 2009 .


Acne vulgaris is a common inflammatory disorder of the skin that involves pilosebaceous units .


This study was conducted to compare the efficacy of oral azithromycin with oral doxycycline in the treatment of acne vulgaris in our population .


This randomized controlled trial was conducted in the dermatology department of Lady Reading Hospital , Peshawar from January to December 2011 .


All male and female patients of age ( 14-30 years ) having moderate acne vulgaris on face only were included in the study .


Patients were randomly divided into two groups .


Patients in first group were given azithromycin 500 mg daily before meal for 4 consecutive days monthly for 3 months while patients in second group were given doxycycline 100 mg daily after meals for 3 months .


Patients were followed up after taking treatment for three months to see the response of each drug .


Response was graded as excellent , good , moderate , mild and no response .


A total of 386 patients equally divided in azithromycin and doxycycline groups .


Male to female ratio in azithromycin and doxycycline groups was 0.82:1.11 and 0.89:1.04 respectively .


Mean age in both groups was 18.45 2.91 years and 17.96 2.59 years respectively .


In azithromycin group , an excellent response was noted in 6 ( 3.1 % ) , and good response was observed in 44 ( 22.8 % ) patients .


In doxycycline group 22 ( 11.4 % ) patients had excellent and 107 ( 55.4 % ) patients had good response .


The difference being statistically significant .


Doxycycline is a better option fdr treatment of acne vulgaris as compared to azithromycin .


Residents often teach medical students , other residents , and patients .


However , few residents get feedback about their teaching .


This study 's objective was to determine if feedback from medical students increases resident teaching identity .


This was a stratified , single blinded , randomized controlled trial of an educational intervention .


Residents were stratified based on year of residency and then randomized to receive feedback by medical students or not .


Medical students evaluated resident teaching effectiveness by ranking resident ability to apply the five microskills for clinical teaching and to role model being an effective clinician .


Residents were surveyed to determine their level of teacher identity before and after the intervention .


Allocation concealment and intention to treat principles were used .


All residents ( n = 32 ) that met inclusion criteria participated with complete response rate to both pre-intervention and post-intervention surveys .


There was no difference in teaching identity between residents who received feedback and those who did not , except in one subscale of the Teacher Identity Scale-global teaching identity , where residents who received medical student feedback scored lower .


There was no difference between intervention and control group in resident teaching identity over time .


The residents found feedback important .


This was a randomized controlled trial with strong methodology that helps advance understanding of the importance of medical student feedback on resident teaching .


No available treatments slow or halt progression of multiple system atrophy , which is a rare , progressive , fatal neurological disorder .


In a mouse model of multiple system atrophy , rifampicin inhibited formation of - synuclein fibrils , the neuropathological hallmark of the disease .


We aimed to assess the safety and efficacy of rifampicin in patients with multiple system atrophy .


In this randomised , double-blind , placebo-controlled trial we recruited participants aged 30-80 years with possible or probable multiple system atrophy from ten US medical centres .


Eligible participants were randomly assigned ( 1:1 ) via computer-generated permuted block randomisation to rifampicin 300 mg twice daily or matching placebo ( 50 mg riboflavin capsules ) , stratified by subtype ( parkinsonian vs cerebellar ) , with a block size of four .


The primary outcome was rate of change ( slope analysis ) from baseline to 12 months in Unified Multiple System Atrophy Rating Scale ( UMSARS ) I score , analysed in all participants with at least one post-baseline measurement .


This study is registered with ClinicalTrials.gov , number NCT01287221 .


Between April 22 , 2011 , and April 19 , 2012 , we randomly assigned 100 participants ( 50 to rifampicin and 50 to placebo ) .


Four participants in the rifampicin group and five in the placebo group withdrew from study prematurely .


Results of the preplanned interim analysis ( n = 15 in each group ) of the primary endpoint showed that futility criteria had been met , and the trial was stopped ( the mean rate of change [ slope analysis ] of UMSARS I score was 0.62 points [ SD 0.85 ] per month in the rifampicin group vs 0.47 points [ 0.48 ] per month in the placebo group ; futility p = 0.032 ; efficacy p = 0.76 ) .


At the time of study termination , 49 participants in the rifampicin group and 50 in the placebo group had follow-up data and were included in the final analysis .


The primary endpoint was 0.5 points ( SD 0.7 ) per month for rifampicin and 0.5 points ( 0.5 ) per month for placebo ( difference 0.0 , 95 % CI -0.24 to 0.24 ; p = 0.82 ) .


Three ( 6 % ) of 50 participants in the rifampicin group and 12 ( 24 % ) of 50 in the placebo group had one or more serious adverse events ; none was thought to be related to treatment .


Our results show that rifampicin does not slow or halt progression of multiple system atrophy .


Despite the negative result , the trial does provide information that could be useful in the design of future studies assessing potential disease modifying therapies in patients with multiple system atrophy .


National Institutes of Health , Mayo Clinic Center for Translational Science Activities , and Mayo Funds .


There is no consensus on what type of arthroplasty is best for the treatment of complex proximal humeral fractures in elderly patients .


The purpose of this prospective study was to compare the outcomes of reverse shoulder arthroplasty ( RSA ) and hemiarthroplasty ( HA ) .


Sixty-two patients older than 70 years were randomized to RSA ( 31 patients ) and HA ( 31 patients ) .


One HA patient died at 1 year , and she was excluded .


The mean follow-up was 28.5 months ( range , 24-49 months ) .


Compared with HA patients , RSA patients had significantly higher ( P = .001 ) mean University of California-Los Angeles ( 29.1 vs 21.1 ) and Constant ( 56.1 vs 40.0 ) scores , forward elevation ( 120.3 vs 79.8 ) , and abduction ( 112.9 vs 78.7 ) but no difference in internal rotation ( 2.7 vs 2.6 ; P = .91 ) .


The Disabilities of the Arm , Shoulder , and Hand score was higher in the HA patients ( 17 vs 29 ; P = .001 ) .


In the HA group , 56.6 % of tuberosities healed and 30 % resorbed .


Patients with failure of tuberosities had significantly worse functional outcomes .


There were 2 complications ( intraoperative humeral fracture and superficial infection ) .


One patient was manipulated under general anesthesia because of postoperative stiffness .


Six patients with HA had proximal migration that required revision to RSA .


In the RSA group , 64.5 % of tuberosities healed and 13.2 % resorbed .


Functional outcome was irrespective of healing of the tuberosities .


Notching was observed in only 1 RSA patient .


One patient developed a hematoma and another a deep infection requiring a 2-stage revision to another RSA .


RSA resulted in better pain and function and lower revision rate .


Revision from HA to RSA does not appear to improve outcomes .


This study examined the feasibility of a prototype Web-based acceptance and commitment therapy ( ACT ) program for preventing mental health problems among college students .


Undergraduate first-year students ( N = 76 ) participated between May and November 2011 .


Participants were randomized to ACT or a waitlist , with assessments conducted at baseline , posttherapy , and 3-week follow-up .


Waitlist participants accessed the program after the second assessment .


Program usability/usage data indicated high program acceptability .


Significant improvements were found for ACT knowledge , education values , and depression with ACT relative to waitlist .


Subgroup analyses indicated that ACT decreased depression and anxiety relative to waitlist among students with at least minimal distress .


Within the ACT condition , significant improvements were observed from baseline to 3-week follow-up on all outcome and process measures .


Results provide preliminary support for the feasibility of a Web-based ACT prevention program .


Breast International Group ( BIG ) 2-98 is a randomised phase III trial that tested the effect of adding docetaxel , either in sequence to or in combination with anthracycline-based adjuvant chemotherapy , in women with node-positive breast cancer ( BC ) .


Here , we present the 10-year final trial safety and efficacy analyses .


We also report an exploratory analysis on the predictive value of Ki67 for docetaxel efficacy , in the BIG 2-98 and using a pooled analysis of three other randomised trials .


2887 patients were randomly assigned in a 22 trial design to one of four treatments .


The primary objective was to evaluate the overall efficacy of docetaxel on disease free survival ( DFS ) .


Secondary objectives included comparisons of sequential docetaxel versus sequential control arm , safety and overall survival ( OS ) .


Ki67 expression was centrally evaluated by immunohistochemistry .


After a median follow-up of 10.1 years , the addition of docetaxel did not significantly improve DFS or OS ( hazard ratio ( HR ) = 0.91 , 95 % confidence interval ( CI ) = 0.81-1 .04 ; P = 0.16 and HR = 0.88 , 95 % CI = 0.76-1 .03 ; P = 0.11 , respectively ) .


Sequential docetaxel did not improve DFS compared to the sequential control arm ( HR = 0.86 , 95 % CI = 0.72-1 .03 ; P = 0.10 ) .


In oestrogen receptor ( ER ) - positive tumours with Ki6714 % , the addition of docetaxel resulted in 5.4 % improvement in 10-year OS ( P = 0.03 , test for interaction = 0.1 ) .


In a multivariate model , there was a trend for improved DFS and OS in ER-positive patients with high Ki67 and treated with docetaxel ( HR = 0.79 , 95 % CI = 0.63-1 .01 ; P = 0.05 and HR = 0.76 , 95 % CI = 0.57-1 .01 ; P = 0.06 , respectively ) .


A pooled analysis of four randomised trials showed a benefit of taxanes in highly proliferative ER-positive disease but not in low proliferating tumours ( interaction test P = 0.01 ) .


The DFS benefit previously demonstrated with sequential docetaxel is no longer observed at 10years .


However , an exploratory analysis suggested a benefit of docetaxel in patients with highly proliferative ER-positive BC .


A wide range of herbal plants have been reported to treat various gynecological problems of women .


This study was set out to investigate the effect of ginger ( Zingiber officinale ) on heavy menstrual bleeding ( HMB ) in high school girls .


Ninety-two young women who experienced HMB and met the inclusion criteria were recruited in this study .


Participants were evaluated for six consecutive menstrual cycles .


During 3 assessment cycles , their HMB was confirmed by Pictorial Blood Assessment Chart .


They were then randomly allocated to two study groups to receive either ginger or placebo capsules .


The participants filled in the same chart during three intervention cycles .


The level of menstrual blood loss dramatically declined during the three intervention cycles in ginger-receiving group .


The decrease of blood loss in ginger-receiving group was significantly more remarkable than that of participants receiving placebo ( p < 0.001 ) .


Minimum number of participants reported adverse effects .


HMB is highly prevalent among young women .


Considering the significance of appropriate and timely treatment and also the importance of prevention of unwanted consequences , ginger may be considered as an effective therapeutic option for HMB .


Early oral feeding ( EOF ) following colorectal surgery can accelerate patient recovery and shorten hospital stay .


However , some patients are intolerable to postoperative early oral feeding .


The aim of this study was to evaluate the tolerability of EOF following laparoscopic colorectal cancer surgery and the effects of intravenous lidocaine .


The cohort in this randomized , placebo-controlled trial ( ClinicalTrial.gov , NCT01346917 ) comprised of 77 patients undergoing elective laparoscopic colorectal cancer surgery .


For patients randomized to the lidocaine group , a loading dose of 1mg/kg lidocaine prior to skin incision , and a continuous dose of 1mg/kg/h lidocaine with 90mg ketorolac ( non-steroidal anti-inflammatory drug ) ( in normal saline , total 240mL ) was administered for 24h .


Patients randomized to the placebo group received a loading dose of 5mL saline and a continuous dose of 90mg ketorolac in 240mL saline .


The primary outcome measure was prevalence of postoperative nausea/vomiting and intolerance to EOF .


Altogether , 68 patients completed the study and were analyzed .


Postoperative nausea and vomiting were higher in the control group but did not reach statistical significance ( P = 0.054 ) .


Tolerability of EOF was 96.9 % in the lidocaine group and 91.7 % in the control group ( P = 0.62 ) .


There was no difference in postoperative pain , opioid consumption , bowel function recovery or postoperative hospital stay .


Perioperative intravenous lidocaine administered for laparoscopic colorectal cancer surgery might reduce postoperative nausea and vomiting .


However , a high tolerability to EOF following colorectal surgery can be achieved by laparoscopic surgery alone without other supportive treatment .


Developing and evaluating interventions for patients with age-associated disorders is a rising field in psychotherapy research .


Its methodological challenges include the high between-subject variability and the wealth of influencing factors associated with longer lifetime .


Latent change score modeling ( LCSM ) , a technique based on structural equation modeling , may be well suited to analyzing longitudinal data sets obtained in clinical trials .


Here , we used LCSM to evaluate the antidepressant effect of a combined cognitive behavioral/cognitive rehabilitation ( CB/CR ) intervention in Alzheimer 's disease ( AD ) .


LCSM was applied to predict the change in depressive symptoms from baseline as an outcome of the CORDIAL study , a randomized controlled trial involving 201 patients with mild AD .


The participants underwent either the CORDIAL CB/CR program or standard treatment .


Using LCSM , the model best predicting changes in Geriatric Depression Scale scores was determined based on this data set .


The best fit was achieved by a model predicting a decline in depressive symptoms between before and after testing .


Assignment to the intervention group as well as female gender revealed significant effects in model fit indices , which remained stable at 6 - and 12-month follow-up examinations .


The pre-post effect was pronounced for patients with clinically relevant depressive symptoms at baseline .


LCSM confirmed the antidepressant effect of the CORDIAL therapy program , which was limited to women .


The effect was pronounced in patients with clinically relevant depressive symptoms at baseline .


Methodologically , LCSM appears well suited to analyzing longitudinal data from clinical trials in aged populations , by accounting for the high between-subject variability and providing information on the differential indication of the probed intervention .


The aim of this study is to examine the relationship between time in the therapeutic range ( TTR ) and clinical outcomes in heart failure patients in sinus rhythm treated with warfarin .


We used data from the Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction ( WARCEF ) trial to assess the relationship of TTR with the WARCEF primary outcome ( ischemic stroke , intracerebral hemorrhage , or death ) , with death alone , ischemic stroke alone , major hemorrhage alone , and net clinical benefit ( primary outcome and major hemorrhage combined ) .


Multivariable Cox models were used to examine how the event risk changed with TTR and to compare the high TTR , low TTR , and aspirin-treated patients , with TTR being treated as a time-dependent covariate .


A total of 2217 patients were included in the analyses ; among whom 1067 were randomized to warfarin and 1150 were randomized to aspirin .


The median ( interquartile range ) follow-up duration was 3.6 ( 2.0-5 .0 ) years .


Mean ( SD ) age was 6111.3 years , with 80 % being men .


The mean ( SD ) TTR was 57 % ( 28.5 % ) .


Increasing TTR was significantly associated with reduction in primary outcome ( adjusted P < 0.001 ) , death alone ( adjusted P = 0.001 ) , and improved net clinical benefit ( adjusted P < 0.001 ) .


A similar trend was observed for the other 2 outcomes , but significance was not reached ( adjusted P = 0.082 for ischemic stroke and adjusted P = 0.109 for major hemorrhage ) .


In patients with heart failure in sinus rhythm , increasing TTR is associated with better outcome and improved net clinical benefit .


Patients in whom good quality anticoagulation can be achieved may benefit from the use of anticoagulants .


URL : http://www.clinicaltrials.gov .


Unique identifier : NCT00041938 .


To assess the adequacy of different amounts of local anesthetics ( LA ) in infraclavicular blockade ( ICB ) under ultrasonographic ( US ) guidance and neurostimulation and compare them to the conventional doses under neurostimulation ( NS ) .


In this study 100 patients scheduled for upper limb surgery and suitable for ICB were randomly allocated to 1 of 5 groups : group NS ( NS alone group 0.5 ml/kg LA ) , group FD ( full-dose US group 0.5 ml/kg LA ) , group 30 ( 30 % reduced dose LA 0.35 ml/kg ) , group 50 ( 0.25 ml/kg LA ) and group 70 ( 0.15 ml/kg LA ) .


The ICB was performed under US in conjunction with NS in all groups except group NS in which neurostimulation was used alone .


When necessary local anesthetic supplementation to the operation site was administered during surgery and propofol infusion for sedation ensued .


Evaluation of sensory and motor block was performed for each terminal nerve ( i.e. radial , ulnar , median and musculocutaneous nerves ) .


Block quality ( assessing the need for rescue LA and propofol sedation ) and duration of the block were documented .


None of the patients in the FD and 30 groups required any supplementation or sedation , whereas LA supplementation rates were 5 % in group 50 and 10 % in groups 70 and NS .


The propofol sedation rates were 20 % in group NS , 25 % in group 50 and 40 % in group 70 .


Sensory block was significantly better in groups FD , 30 and NS at 30 min .


A complete block was achieved more rapidly in all nerve territories in the full-dose group ( p = 0.0001 ) .


Block duration was longest in group FD and was significantly longer in group 30 than in the other two groups ( p = 0.0001 ) .


The results show that US guidance is more effective in maintenance of successful ICB than neurostimulation guidance alone and a reduction of LA doses even to 70 % of conventionally used doses seems possible with US guidance .


This article is published in English .


This study aimed to compare the effectiveness and safety of triphasic combined oral contraceptives ( OCs ) containing ethinyl estradiol ( EE ) and norgestimate ( NGM ) and biphasic combined OCs containing EE and desogestrel ( DSG ) in the treatment of mild to moderate acne .


This was an investigator-blinded , randomized , parallel group trial conducted at 3 centers in Thailand .


Female subjects 18-45 years old were assigned to one or the other OCs and evaluated for efficacy and safety parameters at the baseline visit and after 1 , 3 and 6 months of treatment .


Among 201 randomized subjects , data from 93 subjects in the EE/NGM group and 95 subjects in the EE/DSG group were analyzed .


After 6 months of treatment with EE/NGM and EE/DSG , no differences between formulations were found for the decrease in total acne lesion counts ( 74.4 % vs. 65.1 % , respectively , p = .070 ) or facial improvement score .


More women using EE/NGM showed a decrease in severity of facial seborrhea than those using EE/DSG ( p = .005 ) .


No changes in weight were noted in either group as compared to baseline .


Multiphasic OCs containing EE/NGM and EE/DSG provided comparable efficacy and tolerability in the treatment of acne .


However , EE/NGM had a more beneficial effect on facial seborrhea reduction than EE/DSG .


EE/NGM and EE/DSG are multiphasic OCs , which were shown to be clinically equally effective for mild to moderate facial acne , and the multiphasic combined OC with NGM was more effective for women with facial seborrhea .


Clinicians may apply the results of this study when considering treatment options for facial acne and seborrhea .


Forehead and glabella rhytides are treated mostly with neurotoxins , although some practitioners prefer the concurrent use of fillers .


It has been suggested that combination treatments can result in a better overall improvement .


To compare the safety and effectiveness of treatment of forehead and glabellar lines with botulinum toxin A alone versus botulinum toxin A and filler .


Split-face , randomized control trial .


Twenty subjects with forehead/glabellar rhytide complex ( static and dynamic creases ) enrolled .


Subjects were randomized and injected with botulinum toxin alone on one side of the forehead/glabella and hyaluronic acid filler followed by botulinum toxin on the other side .


Blinded ratings were obtained to assess the effectiveness of treatment for static and dynamic rhytides , respectively , at 2-week , 6-week , 3-month , and 6-month follow-up visits .


Subjects performed a self-evaluation at the end of the study .


Adverse events were recorded .


Ratings of both treatments showed comparable efficacy , with 100 % of subjects experiencing improvement from baseline regardless of treatment type at weeks 2 , 6 , and 12 .


Combination treatment produced longer-lasting results in dynamic forehead wrinkles , and greater static and dynamic wrinkle reduction in the glabella at week 24 .


Subject self-evaluations showed that both treatments were effective , with a nominal preference for combination treatment .


Glabella and forehead lines can be effectively and safely reduced with neurotoxin alone as well as neurotoxin in combination with fillers .


Combination treatment may provide a slightly better cumulative benefit and also increase the persistence of effect .


Remote ischemic preconditioning ( RIPC ) by repeated brief limb ischemia/reperfusion reduces myocardial injury in patients undergoing coronary artery bypass grafting ( CABG ) .


Activation of signal transducer and activator of transcription 5 ( STAT5 ) in left ventricular ( LV ) myocardium at early reperfusion is associated with such protection .


Autophagy , i.e. , removal of dysfunctional cellular components through lysosomes , has been proposed as one mechanism of cardioprotection .


Therefore , we analyzed whether or not the protection by RIPC is associated with activated autophagy .


CABG patients were randomized to undergo RIPC ( 35 min blood pressure cuff inflation/5 min deflation ) or placebo ( cuff deflated ) before skin incision ( n = 10/10 ) .


Transmural myocardial biopsies were taken from the LV before cardioplegia ( baseline ) and at early ( 5-10 min ) reperfusion .


RIPC-induced protection was reflected by decreased serum troponin I concentration area under the curve ( 19417 versus 709129 ng/ml 72 h , p = 0.002 ) .


Western blotting for beclin-1-phosphorylation and protein expression of autophagy-related gene 5-12 ( ATG5-12 ) complex , light chain 3 ( LC3 ) , parkin , and p62 was performed .


STAT3 - , STAT5 - and extracellular signal-regulated protein kinase 1/2 ( ERK1/2 ) - phosphorylation was used as positive control to confirm signal activation by ischemia/reperfusion .


Signals of all analyzed autophagy proteins did not differ between baseline and early reperfusion and not between RIPC and placebo .


STAT5-phosphorylation was greater at early reperfusion only with RIPC ( 2.2-fold , p = 0.02 ) .


STAT3 - and ERK1/2-phosphorylation were greater at early reperfusion with placebo and RIPC ( 2.7-fold versus baseline , p0 .05 ) .


Protection through RIPC in patients undergoing CABG surgery does not appear to be associated with enhanced autophagy in LV myocardium at early reperfusion .


The aim of this study was to evaluate the treatment effect of diquafosol 3 % with preservative-free sodium hyaluronate 0.1 % eye drops in dry eye syndrome .


In total , 150 patients with dry eye syndrome were divided randomly into 3 groups .


Group 1 ( 50 patients ) was treated 4 times daily with preserved sodium hyaluronate 0.1 % , group 2 ( 50 patients ) was treated 4 times daily with diquafosol 3 % , and group 3 ( 50 patients ) was treated 4 times daily with diquafosol 3 % and preservative-free sodium hyaluronate 0.1 % eye drops for 3 months .


Ocular surface disease index ( OSDI ) score , tear film break-up time , Schirmer I test , corneal fluorescein staining , and impression cytology were evaluated .


There were significant improvements in the OSDI score , tear film break-up time , Schirmer I score , fluorescein and Rose Bengal staining , goblet cell density , and impression cytological findings in groups 2 and 3 compared with those for group 1 in patients with dry eye syndrome at 1 , 2 , and 3 months ( P < 0.05 ) .


There were statistically significant improvements in the OSDI score ( -8.48 0.97 , -5.69 0.78 ; P = 0.02 ) , fluorescein ( -1.43 0.21 , -1.02 0.18 ; P = 0.03 ) , and Rose Bengal staining ( -1.12 0.26 , -0.75 0.12 ; P = 0.03 ) , goblet cell density ( 89.65 14.39 , 70.36 16.75 ; P = 0.03 ) , and impression cytological findings ( -0.53 0.12 , -0.34 0.90 ; P = 0.01 ) in group 3 compared with those in group 2 at 3 months .


Treatment with diquafosol 3 % with preservative-free sodium hyaluronate 0.1 % was more effective than diquafosol 3 % monotherapy or treatment with preserved sodium hyaluronate 0.1 % in dry eye syndrome .


Preservative-free sodium hyaluronate 0.1 % eye drops can increase the effect of diquafosol 3 % in dry eye syndrome .


The aim of this prospective comparative study was to compare outcomes and complications of humeral diaphyseal fracture non-unions managed with humerus interlocking nail ( HIL ) and locking compression plate ( LCP ) .


40 patients with non-union of humeral diaphyseal fractures were included in this study and were randomly allocated in two groups ; group A had 20 cases treated with HIL and group B had 20 cases treated with LCP .


Clinico-radiological assessments were done for each case up to 2-year follow-up period .


Primary outcome measures ( time to fracture union , union rate ) and secondary outcome measures ( functional outcome and complication such as infection , malunion , delayed union , implant failure , joint stiffness and iatrogenic radial nerve palsy ) were compared between both the groups .


Disabilities of the arm , shoulder and hand ( DASH ) scoring and Steward and Hundley 's scoring system were used to assess functional outcome of the fracture fixation .


There was no significant difference ( p = 0.12 ) in terms of mean fracture union time between group A ( 15.8 4.2 weeks ) and group B ( 17.2 3.8 weeks ) .


Group A had 95 % union rate and group B had 100 % union rate ( p = 0.14 ) .


At the 2-year follow-up visit , there was no significant difference found between both the groups regarding range of motion of shoulder and elbow joint .


There was no significant difference found in final functional outcomes between both the groups on comparing DASH score ( p = 0.14 ) and Steward and Hundley 's score ( p = 0.08 ) .


In terms of complications , there was insignificant difference found between both the groups .


This study concludes that both the implants can be used in non-union of humeral shaft fractures with good functional outcomes and acceptable rate of complications .


The aim of the study was to compare the efficacy of a microorganism-binding ( MB ) dressing with a silver-containing hydrofiber ( SCH ) dressing in controlling the bacterial loads of heavily colonised or locally infected chronic venous leg ulcers , before surgical management with homologous skin grafts .


A randomised comparative single centre study recruited patients presenting with hard-to-heal critically colonised or locally infected leg ulcers , who could be treated with skin grafting .


Inclusion criteria included ; ulcers of vascular aetiology , over 18 years old , a wound duration 6 months and ankle brachial index ( ABPI ) > 0.6 .


Patients were randomly assigned to treatment with SCH dressings ( Aquacel Ag ) or MB dressing ( Cutimed Sorbact ) .


Dressings were changed daily over a four-day observation period , after which they were taken for a skin grafting procedure .


Swab samples from ulcer beds were taken in order to quantify the bacterial load at inclusion ( D0 ) and at the end of the observation period day 4 ( D4 ) .


No antibiotics were administered before or during the evaluation period .


Both groups ( n = 20 SCH , n = 20 MB ) were similar in gender , age , pathophysiology ( both had 15 patients with venous leg ulcers and 5 with arterial leg ulcers ) , ulcer surface , ulcer duration , treatment-related pain and initial bacterial load .


Analysing bacterial load variation showed a significant reduction of bacterial burden at D4 in both groups .


In the SCH group , we found an average bacterial load reduction of 41.6 % , with an average reduction of 73.1 % in the MB group ( p < 0.00001 ) .


No serious adverse events were reported .


Our evaluation confirmed that MB and SCH dressings are effective in reducing the bacterial burden in critically colonised or locally infected chronic leg ulcers , without inducing adverse events , with MB dressings significantly more effective .


There were no external sources of funding for this study .


The authors have no conflicts of interest to declare .


The effectiveness of antimicrobial prophylaxis ( AMP ) in the prevention of surgical site infection ( SSI ) following thyroid and parathyroid surgery remains uncertain .


The objective of this prospective randomized controlled trial ( Ito-RCT1 ) was to assess the effectiveness of AMP in clean neck surgery performed to treat thyroid and parathyroid disease .


Participants comprised patients scheduled for clean neck surgery for thyroid and parathyroid disease at Ito Hospital .


Patients whose surgery included sternotomy or resection of the trachea , larynx , pharynx , or esophagus were excluded .


AMP consisted of 2 g of piperacillin ( PIPC ) ( group A , n = 541 ) or 1 g of cefazolin ( CEZ ) ( group B , n = 541 ) administered intravenously immediately after endotracheal intubation .


Patients in the control group ( Group C , n = 1,082 ) did not receive AMP .


Statistical analysis was performed to compare the AMP group ( Group A + Group B ) with the control group ( Group C ) .


Drug-induced acute reactions correlated to PIPC or CEZ did not occur in the AMP group .


No significant differences in the postoperative incidence of liver or renal dysfunction were seen between the AMP and control groups .


Postoperative incidence of urinary tract infection was significantly higher in the control group ( p = 0.002 ) .


The incidence of SSI events was very low , with only 1 event ( 0.09 % ) in the AMP group and 3 events ( 0.28 % ) in the control group , and this difference between groups was not significant ( p = 0.371 ) .


AMP is not necessary to prevent SSI after clean thyroid or parathyroid surgery .


To investigate how suppression of endogenous testosterone during an 8-week strength training period influences the activity of satellite cells and myonuclei .


Twenty-two moderately trained young men participated in this randomized , placebo-controlled , and double-blinded intervention study .


The participants were randomized to treatment with a GnRH analogue , goserelin ( n = 12 ) , which suppresses testosterone or placebo ( n = 10 ) for 12 weeks .


The strength training period of 8 weeks started after 4 weeks of treatment and included exercises for all major muscles .


Biopsies were obtained from the mid-portion of the vastus lateralis muscle .


Testosterone resting level in goserelin was 10-20 times lower compared with placebo , and the training-induced increase in the level of testosterone was abolished in goserelin .


Training increased satellite cells number in type II fibres by 20 % in placebo and by 52 % in goserelin ( P < 0.01 ) , whereas the myonuclear number significantly increased by 12 % in type II fibres in placebo and remained unchanged in goserelin ( P < 0.05 ) .


No changes in satellite cells and myonuclei were seen in type I fibres in either group .


Data from the microarray analysis indicated that low testosterone affects the bone morphogenetic proteins signalling , which might regulate proliferation vs. differentiation of satellite cells .


Eight weeks of strength training enhances the myonuclear number in type II fibres , and this is largely blocked by the suppression of testosterone .


The data indicate that low testosterone levels could reduce the differentiation of satellite cells to myonuclei via the bone morphogenetic proteins signalling pathway , resulting in reduced increases in lean leg mass .


A previous pilot trial evaluating computer-based training for cognitive-behavioral therapy ( CBT4CBT ) in 77 heterogeneous substance users ( alcohol , marijuana , cocaine , and opioids ) demonstrated preliminary support for its efficacy in the context of a community-based outpatient clinic .


The authors conducted a more definitive trial in a larger , more homogeneous sample .


In this randomized clinical trial , 101 cocaine-dependent individuals maintained on methadone were randomly assigned to standard methadone maintenance or methadone maintenance with weekly access to CBT4CBT , with seven modules delivered within an 8-week trial .


Treatment retention and data availability were high and comparable across the treatment conditions .


Participants assigned to the CBT4CBT condition were significantly more likely to attain 3 or more consecutive weeks of abstinence from cocaine ( 36 % compared with 17 % ; p < 0.05 , odds ratio = 0.36 ) .


The group assigned to CBT4CBT also had better outcomes on most dimensions , including urine specimens negative for all drugs , but these reached statistical significance only for individuals completing the 8-week trial ( N = 69 ) .


Follow-up data collected 6 months after treatment termination were available for 93 % of the randomized sample ; these data indicate continued improvement for those assigned to the CBT4CBT group , replicating previous findings regarding its durability .


This trial replicates earlier findings indicating that CBT4CBT is an effective adjunct to addiction treatment with durable effects .


CBT4CBT is an easily disseminable strategy for broadening the availability of CBT , even in challenging populations such as cocaine-dependent individuals enrolled in methadone maintenance programs .


Hepatitis C virus ( HCV ) genotype 4 accounts for about 13 % of global HCV infections .


Because interferon-containing treatments for genotype 4 infection have low efficacy and poor tolerability , an unmet need exists for effective all-oral regimens .


We examined the efficacy and safety of an all-oral interferon-free regimen of ombitasvir , an NS5A inhibitor , and paritaprevir ( ABT-450 ) , an NS3/4A protease inhibitor dosed with ritonavir ( ombitasvir plus paritaprevir plus ritonavir ) , given with or without ribavirin .


In this multicentre ongoing phase 2b , randomised , open-label combination trial ( PEARL-I ) , patients were recruited from academic , public , and private hospitals and clinics in France , Hungary , Italy , Poland , Romania , Spain , Turkey , and the USA .


Eligible participants were aged 18-70 years with non-cirrhotic , chronic HCV genotype 4 infection ( documented 6 months before screening ) and plasma HCV RNA levels higher than 10,000 IU/mL .


Previously untreated ( treatment-naive ) patients were randomly assigned ( 1:1 ) by computer-generated randomisation lists to receive once-daily ombitasvir ( 25 mg ) plus paritaprevir ( 150 mg ) plus ritonavir ( 100 mg ) with or without weight-based ribavirin for 12 weeks .


Previously treated ( treatment-experienced ) patients who had received pegylated interferon plus ribavirin all received the ribavirin-containing regimen .


The primary endpoint was a sustained virological response ( HCV RNA < 25 IU/mL ) 12 weeks after the end of treatment ( SVR12 ) .


Analysis was by intention to treat .


This study is registered with ClinicalTrials.gov , number NCT01685203 .


Between Aug 14 , 2012 , and Nov 19 , 2013 , 467 patients with HCV infection were screened , of whom 174 were infected with genotype 4.135 patients were randomly assigned to treatment and received at least one dose of study medication ; 86 patients were treatment-naive , of whom 44 received ombitasvir plus paritaprevir plus ritonavir and 42 received ombitasvir plus paritaprevir plus ritonavir with ribavirin , and 49 treatment-experienced patients received the ribavirin-containing regimen .


In previously untreated patients , SVR12 rates were 100 % ( 42/42 [ 95 % CI 916-100 ] ) in the ribavirin-containing regimen and 909 % ( 40/44 [ 95 % CI 783-975 ] ) in the ribavirin-free regimen .


No statistically significant differences in SVR12 rates were noted between the treatment-naive groups ( mean difference -916 % [ 95 % CI -1961 to 129 ] ; p = 0086 ) .


All treatment-experienced patients achieved SVR12 ( 49/49 ; 100 % [ 95 % CI 927-100 ] ) .


In the ribavirin-free group , two ( 5 % ) of 42 treatment-naive patients had virological relapse , and one ( 2 % ) of 44 had virological breakthrough ; no virological failures were recorded in the ribavirin-containing regimen .


The most common adverse event was headache ( 14 [ 29 % ] of 49 treatment-experienced patients and 14 [ 33 % ] of 42 treatment-naive patients ) .


No adverse event-related discontinuations or dose interruptions of study medications , including ribavirin , were noted , and only four patients ( 4 % ) of 91 receiving ribavirin required dose modification for haemoglobin less than 100 g/L or anaemia .


An interferon-free regimen of ombitasvir plus paritaprevir plus ritonavir with or without ribavirin achieved high sustained virological response rates at 12 weeks after the end of treatment and was generally well tolerated , with low rates of anaemia and treatment discontinuation in non-cirrhotic previously untreated and previously treated patients with HCV genotype 4 infection .


AbbVie .


Defibrillation testing by induction and termination of ventricular fibrillation is widely done at the time of implantation of implantable cardioverter defibrillators ( ICDs ) .


We aimed to compare the efficacy and safety of ICD implantation without defibrillation testing versus the standard of ICD implantation with defibrillation testing .


In this single-blind , randomised , multicentre , non-inferiority trial ( Shockless IMPLant Evaluation [ SIMPLE ] ) , we recruited patients aged older than 18 years receiving their first ICD for standard indications at 85 hospitals in 18 countries worldwide .


Exclusion criteria included pregnancy , awaiting transplantation , particpation in another randomised trial , unavailability for follow-up , or if it was expected that the ICD would have to be implanted on the right-hand side of the chest .


Patients undergoing initial implantation of a Boston Scientific ICD were randomly assigned ( 1:1 ) using a computer-generated sequence to have either defibrillation testing ( testing group ) or not ( no-testing group ) .


We used random block sizes to conceal treatment allocation from the patients , and randomisation was stratified by clinical centre .


Our primary efficacy analysis tested the intention-to-treat population for non-inferiority of no-testing versus testing by use of a composite outcome of arrhythmic death or failed appropriate shock ( ie , a shock that did not terminate a spontaneous episode of ventricular tachycardia or fibrillation ) .


The non-inferiority margin was a hazard ratio ( HR ) of 15 calculated from a proportional hazards model with no-testing versus testing as the only covariate ; if the upper bound of the 95 % CI was less than 15 , we concluded that ICD insertion without testing was non-inferior to ICD with testing .


We examined safety with two , 30 day , adverse event outcome clusters .


The trial is registered with ClinicalTrials.gov , number NCT00800384 .


Between Jan 13 , 2009 , and April 4 , 2011 , of 2500 eligible patients , 1253 were randomly assigned to defibrillation testing and 1247 to no-testing , and followed up for a mean of 31 years ( SD 10 ) .


The primary outcome of arrhythmic death or failed appropriate shock occurred in fewer patients ( 90 [ 7 % per year ] ) in the no-testing group than patients who did receive it ( 104 [ 8 % per year ] ; HR 086 , 95 % CI 065-114 ; pnon-inferiority < 00001 ) .


The first safety composite outcome occurred in 69 ( 56 % ) of 1236 patients with no-testing and in 81 ( 65 % ) of 1242 patients with defibrillation testing , p = 033 .


The second , pre-specified safety composite outcome , which included only events most likely to be directly caused by testing , occurred in 32 % of patients with no-testing and in 45 % with defibrillation testing , p = 008 .


Heart failure needing intravenous treatment with inotropes or diuretics was the most common adverse event ( in 20 [ 2 % ] of 1236 patients in the no-testing group vs 28 [ 2 % ] of 1242 patients in the testing group , p = 025 ) .


Routine defibrillation testing at the time of ICD implantation is generally well tolerated , but does not improve shock efficacy or reduce arrhythmic death .


Boston Scientific and the Heart and Stroke Foundation ( Ontario Provincial office ) .


Artemisinin-based combination therapy ( ACT ) has become the standard of care for the treatment of uncomplicated Plasmodium falciparum malaria .


Although several ACT regimens are approved , data guiding optimal choices of ACTs are limited .


We compared short - and long-term outcomes in a cohort of young Ugandan children randomized to 2 leading ACTs .


Overall , 312 children were randomized to artemether-lumefantrine or dihydroartemisinin-piperaquine ( DP ) at the time of the first episode of uncomplicated malaria ( median age , 10.5 months ) .


The same treatment was given for all subsequent episodes of uncomplicated malaria and children were followed until they reached 5 years of age .


The cohort included a subgroup that was human immunodeficiency virus ( HIV ) infected ( n = 44 ) or HIV exposed ( n = 175 ) and prescribed trimethoprim-sulfamethoxazole ( TMP-SMX ) prophylaxis .


Outcomes included time to recurrent malaria following individual treatments and the overall incidences of treatments for malaria , complicated malaria , and hospitalizations .


Among children not prescribed TMP-SMX prophylaxis , 4443 treatments for malaria were given over 790 person-years following randomization .


Treatment with DP was associated with a lower hazard of recurrent malaria over the 84 days after treatment ( hazard ratio , 0.66 ; 95 % confidence interval [ CI ] , .61 -.70 ; P < .001 ) .


Children randomized to DP had a lower incidence of all treatments for malaria ( incidence rate ratio [ IRR ] , 0.85 ; 95 % CI , .75 -.96 ; P = .01 ) , complicated malaria ( IRR , 0.12 ; 95 % CI , .04 -.39 ; P < .001 ) , and hospitalizations ( IRR , 0.31 ; 95 % CI , .13 -.77 ; P = .01 ) .


Among children prescribed TMP-SMX prophylaxis , there were no significant differences in longitudinal outcomes .


Compared to artemether-lumefantrine , the use of DP to treat uncomplicated malaria delayed the time to recurrent malaria and reduced the incidences of treatments for malaria , complicated malaria , and hospitalizations .


NCT00527800 .


The study aimed to investigate the effectiveness of a web-based therapy programme , ` Move it to improve it ' ( Mitii ( ) ) , in children with unilateral cerebral palsy ( UCP ) on occupational performance , upper limb function , and visual perception .


Participants ( n = 102 ) were matched in pairs and randomized to intervention ( Mitii for 20wks ; 26 males , mean age 11y 8mo [ 2y 4mo ] , Manual Ability Classification System level I = 11 , II = 39 , III = 1 ) or control ( standard care ; 25 males , mean age 11y 10mo [ 2y 5mo ] , Manual Ability Classification System level I = 13 , II = 37 ) .


Outcomes were the Assessment of Motor and Process Skills ( AMPS ) , Assisting Hand Assessment , Jebsen-Taylor Test of Hand Function ( JTTHF ) , Melbourne Assessment of Unilateral Upper Limb Function ( MUUL ) , Canadian Occupational Performance Measure ( COPM ) , and Test of Visual Perceptual Skills ( TVPS-3 ) .


Participants completed on average 32.4 hours of Mitii ( range 3.7-74 .7 h ) .


The Mitii group demonstrated significantly greater post-intervention scores than the comparison group on the AMPS , JTTHF dominant upper limb , COPM , and TVPS-3 .


The differences between groups were not clinically significant .


There were no differences between groups on measures of impaired upper limb function .


Mitii delivers individualized , web-based therapy at home and has potential to increase therapy dose .


Mitii can be considered as an option to enhance occupational performance and visual perception for children with UCP .


Inappropriate implantable cardioverter defibrillators ( ICD ) therapies have been associated with multiple adverse effects , including worse quality of life and prognosis .


We evaluated the possibility of predicting atrial fibrillation ( AF ) - related inappropriate ICD shocks through continuous monitoring of device diagnostics .


1404 ICD patients were prospectively followed in an observational research by 74 Italian cardiology centres .


Device diagnostics stored daily information on AF duration and ventricular rate ( VR ) during AF .


Uncontrolled VR was defined as mean VR > 80 beats per minute ( bpm ) and maximum VR > 110 bpm .


Expert electrophysiologists reviewed the ventricular tachycardia/ventricular fibrillation ( VT/VF ) episodes electrograms , stored in the device memory , and classified appropriate detections , inappropriate detection mechanisms and ICD therapy outcomes .


Over a median follow-up of 31 months , 511 ( 36 % ) patients suffered spontaneous VT/VF , which were treated by ICD shocks in a subgroup of 189 ( 13 % ) patients .


Inappropriate detections occurred in 232 ( 16 % ) patients , and inappropriate ICD shocks in 101 ( 7 % ) patients .


AF was the cause of inappropriate shocks in 60 patients .


AF caused 144 inappropriate shocks : 53 % of all inappropriate shocks .


The likelihood of experiencing AF-related inappropriate shocks was 2.4 % at 1 year and 6 % at 5 years .


Uncontrolled VR during AF proved to be an independent predictor of AF-related inappropriate shocks ( OR = 3.02 , p = 0.006 ) ; an alarm set at a VR > 90 bpm or 100 bpm was associated with prediction of AF-related inappropriate shocks with a sensitivity of 73 % or 62 % , respectively .


AF is the most common cause of inappropriate shocks in ICD patients .


Continuous remote monitoring of VR during AF would promptly and efficiently predict AF-related inappropriate shocks .


http://clinicaltrials.gov/ct2/show/NCT01007474 .


To explore the effect of patient-controlled lumbar epidural combined anesthesia with Doula for labor analgesia with ropivacaine and sufentanil , and its influence on the progress of labor , and outcomes of mother and infant .


Two hundred parturients that requested labor analgesia were randomly selected by patient-controlled lumbar epidural combined anesthesia with Doula as the observation group , meanwhile another 200 parturients were selected as the control group without any analgesic measurements .


Labor pain score , labor duration , blood gas analysis results , the incidence of cesarean section , neonatal asphyxia , and postpartum hemorrhage were compared between the two groups .


Compared with the control group , labor analgesic effect was remarkable , the cesarean section rate was significantly reduced in observation group , and the difference was statistically significant ( p < 0.05 ) , but with respect to the duration of labor , maternal , postpartum hemorrhage , and neonatal asphyxia , there was no statistical significance between the two groups ( p > 0.5 ) .


In the observation group regarding maternal and neonatal blood gas analysis results , PO2 was higher and PCO2 was lower than those in the control group .


The differences were statistically significant ( p < 0.05 ) .


Labor analgesia by patient-controlled lumbar epidural combined anesthesia accompanied with Doula with ropivacaine and sufentanil is effective , safe , reliable , has no adverse effects , and reduces cesarean section rate .


Ventricular arrhythmias are common after acute myocardial infarction ( AMI ) .


Endothelin ( ET ) is a mediator of microvascular dysfunction and cardiac remodeling with arrhythmogenic potential .


The aim of this study was to assess safety and feasibility of selective ET-A receptor blockade in ST-elevation acute coronary syndrome ( STE-ACS ) within a larger randomized trial .


Patients with posterior-wall STE-ACS were randomly assigned to receive intravenous BQ-123 at 400 nmol/min or placebo over 60 min , starting immediately prior to primary percutaneous coronary intervention .


Twenty-four hour Holter recordings were performed during hospitalization for STE-ACS and after 6-8 weeks .


The predefined primary endpoint was the documentation of ventricular tachycardia and/or late potentials at follow-up .


There was no significant difference in the predefined primary endpoint at 45 ( 33-62 ) days ( 0/16 ( 0 % ) in BQ-123 treated patients vs. 1/14 ( 7 % ) in the placebo group , p = 0.465 ) .


At 2 ( 1-3 ) days , an increase in the total number of supraventricular extrasystoles ( SVES ) / 24 h in patients randomized to BQ-123 ( 45 ( 17-165 ) beats vs. 11 ( 5-72 ) beats in placebo treated patients , p = 0.025 ) occurred .


This increase was also observed at 45 days ( 105 ( 37-216 ) beats vs. 11 ( 3-98 ) beats in placebo treated patients , p = 0.037 ) .


There was no significant difference regarding other rhythmologic secondary endpoints between the two groups .


Based on the analysis of long-term ECG data , short-term administration of BQ-123 after AMI was safe .


Because of the small sample size , no firm conclusion regarding antiarrhythmic efficacy can be drawn .


Hypertension self-management has been shown to improve systolic blood pressure ( BP ) control , but longer-term economic and clinical impacts are unknown .


The purpose of this article is to examine clinical and economic outcomes 18 months after completion of a hypertension self-management trial .


This study is a follow-up analysis of an 18-month , 4-arm , hypertension self-management trial of 591 veterans with hypertension who were randomized to usual care or 1 of 3 interventions .


Clinic-derived systolic blood pressure obtained before , during , and after the trial were estimated using linear mixed models .


Inpatient admissions , outpatient expenditures , and total expenditures were estimated using generalized estimating equations .


The 3 telephone-based interventions were nurse-administered health behavior promotion , provider-administered medication adjustments based on hypertension treatment guidelines , or a combination of both .


Intervention calls were triggered by home BP values transmitted via telemonitoring devices .


Clinical and economic outcomes were examined 12 months before , 18 months during , and 18 months after trial completion .


Compared with usual care , patients randomized to the combined arm had greater improvement in proportion of BP control during and after the 18-month trial and estimated proportion of BP control improved 18 months after trial completion for patients in the behavioral and medication management arms .


Among the patients with inadequate baseline BP control , estimated mean systolic BP was significantly lower in the combined arm as compared with usual care during and after the 18-month trial .


Utilization and expenditure trends were similar for patients in all 4 arms .


Behavioral and medication management can generate systolic BP improvements that are sustained 18 months after trial completion .


URL : http://www.clinicaltrials.gov .


Unique identifier : NCT00237692 .


Melanocytic nevi ( MN ) are the most important simulants of melanoma .


Although acquired nevi are usually clinically stable , they may show abnormal clinical behavior .


This study assessed the histological changes and prognosis of acquired MN with changing clinical behavior in Egyptian patients .


The study included 236 patients that were classified into two groups ; Group A included nevi with abnormal clinical presentation and Group B included clinically typical nevi .


Each group included 118 patients with a predominance of female patients .


Abnormal clinical presentation in Group A included altered pigmentation ( 35.6 % ) , rapid enlargement ( 30.5 % ) , keratotic changes ( 16.9 % ) , inflammation ( 7.6 % ) , ulceration ( 5.1 % ) , and hemorrhage ( 4.2 % ) .


Typical histological features were significantly higher ( p = 0.008 ) in Group B ( 99.2 % ) compared with Group A ( 87.3 % ) .


Atypical histological features were significantly higher ( p = 0.002 ) in Group A , with higher numbers of ulcerative and altered pigmented nevi .


Malignant changes showed no significant difference ( p = 0.47 ) between the two groups .


No relapse was recorded after excision of any lesion .


Among Egyptians , changing clinical behavior of MN may show histological atypia but low risk of malignant transformation .


Early excision and follow-up of ulcerative and altered pigmented nevi are recommended .


The GeparQuattro study showed that adding capecitabine or prolonging the duration of anthracycline-taxane-based neoadjuvant chemotherapy from 24 to 36 weeks did not increase pathological complete response ( pCR ) rates .


Trastuzumab-treated patients with HER2-positive disease showed a higher pCR rate than patients with HER2-negative disease treated with chemotherapy alone .


We here present disease-free ( DFS ) and overall survival ( OS ) analyses .


Patients ( n = 1495 ) with cT 3 tumors , or negative hormone-receptor status , or positive hormone-receptor and clinically node-positive disease received four times epirubicin/cyclophosphamide and were thereafter randomly assigned to four times docetaxel ( Taxotere ) , or four times docetaxel/capecitabine over 24 weeks , or four times docetaxel followed by capecitabine over 36 weeks .


Patients with HER2-positive tumors received 1 year of trastuzumab , starting with the first chemotherapy cycle .


Follow-up was available for a median of 5.4 years .


Outcome was not improved for patients receiving capecitabine ( HR 0.92 ; P = 0.463 for DFS and HR 93 ; P = 0.618 for OS ) as well as for patients receiving 36 weeks of chemotherapy ( HR 0.97 ; P = 0.818 for DFS and HR 0.97 ; P = 0.825 for OS ) .


Trastuzumab-treated patients with HER2-positive disease showed similar DFS ( P = 0.305 ) but a significantly better adjusted OS ( P = 0.040 ) when compared with patients with HER2-negative disease treated with chemotherapy alone .


Recorded long-term cardiac toxicity was low .


Long-term results , similar to the results of pCR , do not support the use of capecitabine in the neoadjuvant setting in addition to an anthracycline-taxane-based chemotherapy .


However , the results support previous data showing a benefit of trastuzumab as predicted by higher pCR rates .


This randomized controlled pilot trial was conducted to evaluate the clinical efficacy of massage therapy ( MT ) for relief of symptoms of gastroesophageal reflux disease ( GERD ) .


The hypothesis was that , when compared to infants who received nonmassage therapy , infants who received MT would display fewer GERD symptoms , greater weight gain , greater amount of sleep , lower cortisol levels before and after treatment , and lower daily ( area under the curve [ AUC ] ) cortisol secretion .


Participants were 36 infants born at term , 4-10 weeks of age at enrollment , healthy except for a diagnosis of GERD by their pediatrician , and with a score of at least 16 on the Infant Gastroesophageal Reflux Questionnaire-Revised ( I-GERQ-R ) .


Infants were randomized to receive either MT or a nonmassage sham treatment in their homes for 30 min twice a week for 6 weeks .


Data collectors and parents were blind to study condition .


GERD symptoms decreased in both groups and weight increased .


Pretreatment salivary cortisol levels decreased significantly over time in the massage group while increasing in the nonmassage group .


Daily cortisol level also decreased in the massage group and increased in the nonmassage group , but the difference was not significant .


MT administered by a professional therapist did not affect symptoms of GERD differently than a sham treatment but did decrease infant stress as measured by cortisol .


Research focusing on stress reduction in infants with GERD and multimodal treatments addressing GERD symptoms may yield the most effective treatment .


Rotation of femoral components could be optimized to improve function and durability of the knee joint .


The purpose of the present study was to assess rotational alignment of femoral component comparing between CT-based , custom cutting blocks and the contemporary total knee arthroplasty , instrument technique .


The prospective control study of 80 patients underwent total knee arthroplasty by using PFC Sigma PS total knee design .


Rotation offemoral component was analyzed in all patients using postoperative CT scan .


Forty patients were perfonned on by using CT-based , patient-specific cutting blocks with femoral rotational axis relative to transepicondylar axis while forty patients were performed on by using contemporaly instrumentation with alignment at 3 degrees external rotation from posterior condylar line .


The rotation of the femoral component with external rotation ofmore than 3 degrees or internal rotation was considered outlier .


There was no statistically significant difference among ages , gender ; BMI , pre-operative mechanical axis between the two groups .


There were eleven outliers in conventional group ( range , 5 degrees ofexternal rotation to 3 degrees of internal rotation ) , three femoral components were in excessive external rotation with the angle of more than 3 degrees and eight femnoral components were in internal rotation .


In contrast with custom cutting block group was no outliers offemoral rotation .


The average rotational alignment was 1.040 + / - 0.62 external rotation from epicondylar axis in custom cutting group and 1.58 + / - 1.750 in contemporary group .


Custom cutting , block technique significantly reduced the outlier of the femoral component rotation and aided in positioning of the femoral component in optimal alignment .


The improvement of femoral rotation showed no difference in clinical outcome between the two groups .


The purpose of the study was to analyze the potential capacity of a dietary supplement , based on gamma linolenic acid , vitamin E , vitamin C , beta-carotene , coenzyme Q10 and Vitis Vitifera , to reduce side effects , in particular the dry skin , erythema and desquamation , due to treatment with oral isotretinoin , and evaluate the ability of the product to increase adherence to therapy in patients with acne .


Forty-eight patients with nodular acne ( 32 females and 16 males ) were randomly divided into 2 groups : 24 received isotretinoin therapy ( 20-30 mg/day ) for 6 months associated to dietary supplement ( twice a day ) , while the other 24 patients received only isotretinoin ( 20-30 mg/day ) for 6 months .


For all patients the degree of acne severity , through GAGS ( Global Acne Grading System ) , the sebum production by Sebutape , the hydration by Corneometer and the erythema by Mexameter , were measured .


We have also evaluated the adherence to treatment , asking to patients how many days a week they follow the therapy .


Patients treated with dietary supplement had lower side effects , with a less degree of erythema and dryness , and greater degree of hydration ; a greater adherence to therapy was also reported .


Thanks to antioxidant and moisturizing properties , the dietary supplement containing gamma linolenic acid , vitamin E , vitamin C , betacarotene , coenzyme Q10 and Vitis Vitifera , can be considered a useful supplement in the treatment and prevention of dry skin associated with the use of oral isotretinoin .


Integrating antenatal care ( ANC ) and HIV care may improve uptake and retention in services along the prevention of mother-to-child transmission ( PMTCT ) cascade .


This study aimed to determine whether integration of HIV services into ANC settings improves PMTCT service utilization outcomes .


ANC clinics in rural Kenya were randomized to integrated ( 6 clinics , 569 women ) or nonintegrated ( 6 clinics , 603 women ) services .


Intervention clinics provided all HIV services , including highly active antiretroviral therapy ( HAART ) , whereas control clinics provided PMTCT services but referred women to HIV care clinics within the same facility .


PMTCT utilization outcomes among HIV-infected women ( maternal HIV care enrollment , HAART initiation , and 3-month infant HIV testing uptake ) were compared using generalized estimating equations and Cox regression .


HIV care enrollment was higher in intervention compared with control clinics [ 69 % versus 36 % ; odds ratio = 3.94 , 95 % confidence interval ( CI ) : 1.14 to 13.63 ] .


Median time to enrollment was significantly shorter among intervention arm women ( 0 versus 8 days , hazard ratio = 2.20 , 95 % CI : 1.62 to 3.01 ) .


Eligible women in the intervention arm were more likely to initiate HAART ( 40 % versus 17 % ; odds ratio = 3.22 , 95 % CI : 1.81 to 5.72 ) .


Infant testing was more common in the intervention arm ( 25 % versus 18 % ) , however , not statistically different .


No significant differences were detected in postnatal service uptake or maternal retention .


Service integration increased maternal HIV care enrollment and HAART uptake .


However , PMTCT utilization outcomes were still suboptimal , and postnatal service utilization remained poor in both study arms .


Further improvements in the PMTCT cascade will require additional research and interventions .


The use of 17-alpha-hydroxyprogesterone caproate ( 17P ) has been shown to reduce preterm delivery in women who have had a prior preterm birth .


The role of 17P in women with arrested preterm labor is less certain .


To compare the preterm birth rate and neonatal outcome in women with arrested preterm labor randomized to receive 17P or placebo .


Women with arrested preterm labor were randomized to weekly injections of either 17P ( 250mg ) or placebo .


Maternal and neonatal outcome were evaluated .


Forty-five singleton pregnancies were randomized after successful tocolysis ; 22 received 17P while 23 got placebo .


Gestational age at delivery ( p = 0.067 ) and the interval from treatment to delivery ( p = 0.233 ) were not affected by 17P .


Significantly less women in the 17P group delivered at < 34 weeks ( 14 versus 21 , p = 0.035 ) .


There was also a significant reduction in the risk of neonatal sepsis ( p = 0.047 ) and gr III/IV intraventricular hemorrhage ( IVH ) ( p = 0.022 ) in the 17P group .


In this study , 17P did not delay the interval to delivery after successful preterm labor , but births < 34 weeks as well as neonatal sepsis and IVH were reduced by 17P treatment .


Responses with greater amplitude were recorded when carrier frequencies were modulated at 37 , 40 , and 43 Hz .


These responses can be recorded even in patients with significant sensorineural hearing loss , from the sternocleidomastoid ( SCM ) muscle for a 500 Hz tone , 100 % modulated at 40 Hz .


To determine the best carrier and modulating frequencies to evoke steady-state myogenic responses .


The present study investigated 156 ears of 78 normal-hearing young adults , with carrier frequencies of 250 , 500 , and 1000 Hz , modulated at 20 , 37 , 40 , 43 , 70 , 77 , and 80 Hz , with an intensity of 95 dBA .


Furthermore , we observed responses evoked by stimulus carrier frequency of 500 Hz , modulated at 40 Hz , with an intensity of 95 dBA in a group of five subjects with severe sensorineural loss .


Responses were found for all stimuli studied ( p < 0.01 ) .


Modulated stimuli at frequencies of 37 , 40 , and 43 Hz evoked better steady-state vestibular evoked myogenic potential ( S-VEMP ) ( p < 0.05 ) .


No statistically significant differences were found between the group of normal hearers and the group of subjects with hearing loss ( p = 0.431 ) , for the stimulus used .


To examine the effects of a ten week deadlift training program on peak torque and agonist-antagonist coactivation .


Fifty-four untrained subjects ( mean age = 23 years ) participated in this investigation , and were randomly assigned to a training ( males , n = 17 ; females , n = 17 ) or control ( males , n = 9 ; females , n = 11 ) group .


The subjects in the training group performed deadlifts twice per week .


Isometric peak torque for the leg extensors and flexors and surface electromyographic ( EMG ) amplitude for the superficial quadriceps and biceps femoris muscles were assessed .


Deadlift training increased leg extension peak torque for the males ( P = .008 , Cohen 's d = 0.43 ) and females ( P = .003 , d = 0.48 ) .


Leg flexion peak torque improved for the females ( P = .001 , d = 0.45 ) .


Increased EMG amplitude for the superficial quadriceps femoris muscles when they served as agonists was demonstrated for the females ( P = .010 , d = 0.40 ) , but not the males ( P = .059 , d = 0.20 ) .


For both sexes , the effect sizes for the decline in biceps femoris coactivation were large .


Deadlift training elicited improvements in strength and agonist-antagonist coactivation in untrained subjects , and particularly , novice females .


Kisspeptin-54 , an endogenous naturally occurring ligand of the G protein-coupled receptor-54 , stimulates GnRH-gonadotropin secretion and suppresses metastases in animal models of cancer but is subject to rapid degradation and inactivation .


TAK-448 is an investigational oligopeptide analog of the fully active 10-amino acid C terminus of kisspeptin-54 .


This phase 1 study evaluated the safety , pharmacokinetics , and pharmacodynamics of TAK-448 in healthy subjects and patients with prostate cancer ( PC ) .


Healthy subjects aged 50 years or older received TAK-448 sc as a single-bolus or 2-hour infusion ( 0.01-6 mg/d ; part A ) and as a 14-day sc administration ( 0.01-1 mg/d ; part B ) .


In a subsequent , open-label , phase 1 study in PC patients aged 40-78 years , TAK-448 was given as a 1-month depot formulation .


Eighty-two healthy subjects received TAK-448 ; 30 received placebo .


Grades 1-2 adverse events were reported in 26 % of subjects during TAK-448 treatment .


All dosing regimens resulted in dose-proportional exposures .


The maximum observed plasma concentration occurred after 0.25-0 .5 hours , and median terminal elimination half-life was 1.4-5 .3 hours .


T increased approximately 1.3 - to 2-fold by 48 hours after a single bolus or 2 hour injections , whereas during the 14-day infusion , at doses above 0.1 mg/d , T dropped to below-baseline values by 60 hours and reached a subsequently sustained below-castration level by day 8 .


In PC patients , T decreased to less than 20 ng/dL in four of five patients dosed with 12 or 24 mg TAK-448 sc-depot injections .


The prostate-specific antigen decreased greater than 50 % in all patients dosed with 24 mg .


Continuous TAK-448 infusion was well tolerated by healthy males and resulted in sustained T suppression .


Depot injection in patients with PC similarly reduced T and resulted in prostate-specific antigen responses .


To evaluate the clinical efficacy , safety , and costs of percutaneous occlusive balloon catheter-assisted ureteroscopic lithotripsy ( POBC-URSL ) for large impacted proximal ureteral calculi .


156 patients with impacted proximal ureteral stones 1.5 cm in size were randomized to ureteroscopic lithotripsy ( URSL ) , POBC-URSL , and percutaneous nephrolithotomy ( PNL ) group between May 2010 and May 2013 .


For URSL , the calculi were disintegrated with the assistance of anti-retropulsion devices .


POBC-URSL was performed with the assistance of an 8F percutaneous occlusive balloon catheter .


PNL was finished with the combination of an ultrasonic and a pneumatic lithotripter .


A flexible ureteroscope and a 200m laser fiber were used to achieve stone-free status to a large extent for each group .


Variables studied were mean operative time , auxiliary procedure , postoperative hospital stay , operation-related complications , stone clearance rate , and treatment costs .


The mean lithotripsy time for POBC-URSL was shorter than URSL , but longer than PNL ( 42.68.9 minutes vs 66.715.3 minutes vs 28.16.3 minutes , p = 0.014 ) .


The auxiliary procedure rate and postoperative fever rate for POBC-URSL were significantly lower than URSL and comparable to PNL ( p < 0.01 , p = 0.034 ) .


POBC-URSL was superior to URSL with regard to the stone clearance rate at 3 days postoperatively , and as good as PNL ( 98.1 % vs 75.0 % vs 96.2 % , p < 0.01 ) .


The postoperative hospital stay and hematuria rate were lower in POBC-URSL group than PNL group and similar to URSL group ( p = 0.016 , p < 0.01 ) .


The treatment costs were lowest in POBC-URSL group ( $ 1205.0 $ 113.9 vs $ 1731.7 $ 208.1 vs $ 2446.4 $ 166.4 , p = 0.004 ) .


For large impacted proximal ureteral calculi , POBC-URSL was associated with a higher stone clearance rate , fewer complications and costs .


POBC-URSL combined the advantages of URSL and PNL .


To evaluate the effect of vaginal misoprostol on intraoperative bleeding during myomectomy .


In this randomized clinical trial , 80 women with myomas were randomly assigned to receive 200 g misoprostol or placebo ( vitamin B6 ) 3 h before surgery .


Blood loss during surgery , postoperative need for blood transfusion , and the hemoglobin level before surgery , and 6 and 12 h after surgery were assessed in two groups .


Mean age and the mean preoperative and postoperative Hb levels were not significantly different between the two groups .


Mean duration of surgery and mean estimated blood loss were significantly higher in control group .


Nine ( 22.5 % ) patients in control group needed blood transfusion while there was no need blood transfusion in misoprostol group ( p = 0.001 ) .


A single dose of vaginal misoprostol is effective in reducing hemorrhage during myomectomy .


Hepatitis C virus ( HCV ) infection is an important cause of liver cancer in Thailand .


The highest prevalence of anti-HCV positive among Thai blood donors is found in the northeastern region .


The present analysis of the genotype distribution among anti-HCV positive northeastern-Thai blood donors was conducted to provide a base for the epidemiological pattern of HCV infection in this region .


A total of 112 HCV seropositive healthy blood donors were randomly selected and tested for the presence of HCV-RNA by RT-PCR .


HCV-RNA positive samples were genotyped by direct sequencing at core region genomes and confirmed by phylogenetic analysis .


HCV viremia was found in 94.6 % ( 106/112 ) of HCV seropositive blood donors .


There were 3 major genotypes distributed among this population .


HCV genotype 3a was the most prevalent ( 71.7 % ) followed by genotypes 1a ( 7.5 % ) , 1b ( 7.5 % ) , 6i ( 3.8 % ) , 6f ( 2.8 % ) and 6n ( 1.9 % ) .


HCV genotype 3a in asymptomatic infections in northeastern Thailand is significantly higher than other previous reports .


Subgenotype 6 prevalence is less than in neighboring countries and distribution patterns differ .


The findings are relevant as predictors for using interferon therapy in this population .


Many bacterial pathogens causing respiratory infections in children are common residents of the respiratory tract .


Insight into bacterial colonization patterns and microbiota stability at a young age might elucidate healthy or susceptible conditions for development of respiratory disease .


To study bacterial succession of the respiratory microbiota in the first 2 years of life and its relation to respiratory health characteristics .


Upper respiratory microbiota profiles of 60 healthy children at the ages of 1.5 , 6 , 12 , and 24 months were characterized by 16S-based pyrosequencing .


We determined consecutive microbiota profiles by machine-learning algorithms and validated the findings cross-sectionally in an additional cohort of 140 children per age group .


Overall , we identified eight distinct microbiota profiles in the upper respiratory tract of healthy infants .


Profiles could already be identified at 1.5 months of age and were associated with microbiota stability and change over the first 2 years of life .


More stable patterns were marked by early presence and high abundance of Moraxella and Corynebacterium/Dolosigranulum and were positively associated with breastfeeding in the first period of life and with lower rates of parental-reported respiratory infections in the consecutive periods .


Less stable profiles were marked by high abundance of Haemophilus or Streptococcus .


These findings provide novel insights into microbial succession in the respiratory tract in infancy and link early-life profiles to microbiota stability and respiratory health characteristics .


New prospective studies should elucidate potential implications of our findings for early diagnosis and prevention of respiratory infections .


Clinical trial registered with www.clinicaltrials.gov ( NCT00189020 ) .


To compare the difference in the efficacy on gait time cycle of ischemic stroke between yin-yang respiratory reinforcing and reducing needling technique ( yin-yang needling ) and the conventional acupuncture .


Sixty cases of ischemic stroke were randomized into a conventional acupuncture group and a yin-yang needling group , 30 cases in each one .


The basic treatment ( the control of blood pressure , blood sugar and blood lipid , the intravenous drops of ginkgo leaf extract and dipyridamole injection and vinpocetine injection ) were applied in the two groups .


Additionally , in the conventional acupuncture group , the acupoints of the Stomach Meridian of Foot-Yangming [ Biguan ( ST 31 ) , Liangqiu ( ST 34 ) , Zusanli ( ST 36 ) , Shangjuxu ( ST 37 ) , Xiajuxu ( ST 39 ) , etc. ] were selected and stimulated with the even needling technique .