Secondary measures include levels of anxiety and social functioning .


Participants with symptoms of low mood will be recruited from the community through newspaper adverts and also via the AOD website .


Participants will receive either immediate or delayed access to guided CBT self-help classes - the eight session LLTTF course .


The primary endpoint will be at 6 months at which point the delayed group will be offered the intervention .


Levels of depression , anxiety and social functioning will be assessed and an economic analysis will be carried out .


This RCT will test whether the LLTTF intervention is effective and/or cost-effective .


If the LLTTF community-based classes are found to be cost effective , they may be helpful as both an intervention for those already seeking care in the health service , as well as those seeking help outside that setting , widening access to psychological therapy .


Current Controlled Trials ISRCTN86292664 .


High levels of oxidative stress can have considerable impact on the outcomes of in vitro fertilisation ( IVF ) .


Recent studies have reported that melatonin , a neurohormone secreted from the pineal gland in response to darkness , has significant antioxidative capabilities which may protect against the oxidative stress of infertility treatment on gametes and embryos .


Early studies of oral melatonin ( 3-4mg / day ) in IVF have suggested favourable outcomes .


However , most trials were poorly designed and none have addressed the optimum dose of melatonin .


We present a proposal for a pilot double-blind randomised placebo-controlled dose-response trial aimed to determine whether oral melatonin supplementation during ovarian stimulation can improve the outcomes of assisted reproductive technology .


We will recruit 160 infertile women into one of four groups : placebo ( n = 40 ) ; melatonin 2mg twice per day ( n = 40 ) ; melatonin 4mg twice per day ( n = 40 ) and melatonin 8mg twice per day ( n = 40 ) .


The primary outcome will be clinical pregnancy rate .


Secondary clinical outcomes include oocyte number/quality , embryo number/quality and fertilisation rate .


We will also measure serum melatonin and the oxidative stress marker , 8-hydroxy-2 ' - deoxyguanosine at baseline and after treatment and levels of these in follicular fluid at egg pick-up .


We will investigate follicular blood flow with Doppler ultrasound , patient sleepiness scores and pregnancy complications , comparing outcomes between groups .


This protocol has been designed in accordance with the SPIRIT 2013 Guidelines .


Ethical approval has been obtained from Monash Health HREC ( Ref : 13402B ) , Monash University HREC ( Ref : CF14/523 -2014000181 ) and Monash Surgical Private Hospital HREC ( Ref : 14107 ) .


Data analysis , interpretation and conclusions will be presented at national and international conferences and published in peer-reviewed journals .


ACTRN12613001317785 .


Women with urinary incontinence ( UI ) frequently present with complaints of sexual problems .


To evaluate the predictors of sexual function improvement after participating in three physical therapy sessions and performing home-based pelvic floor muscle exercises ( PFME ) for the treatment of female UI .


This is a secondary analysis of a randomized trial with a 3-month follow-up in which the sexual function of 54 women with UI was evaluated .


These women joined three supervised physiotherapy sessions that included PFME and health education during 1 month , with a 15-day interval between each session , and kept practicing home-based PFME for a further 2 months .


Sexual function was assessed using the FemaleSexualQuotient , the pelvic floor muscle strength was measured using the modified Oxford scale , and UI was assessed using the InternationalConsultation onIncontinenceQuestionnaire .


The mean of sexual quotient score improved after treatment ( P = 0.001 ) .


With respect to specific domains of sexual function , improvement was observed only in the questions about sexual desire , arousal/excitement , and orgasm .


Before treatment , 18 women ( 33.3 % ) were classified as having sexual dysfunction , and after treatment , eight remained with sexual dysfunction and two other joined this category ( total of 18.5 % ) .


Those women who had sexual dysfunction at baseline experienced a higher level of improvement of the sexual quotient compared with those without sexual dysfunction ( P = 0.001 , 95 % CI = 9.1-31 .9 ) .


A multivariate linear regression with backward elimination revealed the following predictors of improvement of the sexual quotient : higher parity , higher adherence to PFME , improvement in the strength of PFM , and a decrease in the frequency of urine leakage ( R ( 2 ) = 0.497 ) .


PFME was more beneficial with regard to sexual function in those women who presented with sexual dysfunction at baseline .


To evaluate the clinical efficacy of Zhenjingdingzhi decoction in treating insomnia with Qi-deficiency of heart and gallbladder .


We conducted a double-blind , randomized , controlled trial involving 100 patients with insomnia of Qi-deficiency of heart and gallbladder .


Patients were randomly divided into the treatment group ( n = 50 ) and the control group ( n = 50 ) according to a random number table .


The treatment group was given Zhenjingdingzhi decoction , while the control group was treated with Suanzaoren decoction .


The pharmacological treatment lasted for 8 weeks .


The clinical efficacy was assessed by using Spiegel scale , Pittsburgh sleep quality index ( PSQ ) and Traditional Chinese Medicine ( TCM ) syndrome scores .


Comparing Spiegel scores between the two groups at 4 and 8 weeks , the differences in curative effect between the two groups were both significant ( both P < 0.05 ) .


The total effective rate was 46 % in the treatment group and 27.7 % in the control group at 4 weeks , and 80 % and 53.2 % at 8 weeks , respectively ; After 8 weeks , PSQI scores showed that the total effective rates differed significantly between the two groups ( P < 0.01 ) : 84 % in the treatment group and 59.6 % in the control group ; In improving sleep quality and sleep duration , the curative effect of the treatment group was better than that of the control group ( P < 0.05 ) .


TCM syndrome , especially insomnia and palpitation , was improved better in the treatment group after 8 weeks as compared to that in the control group ( P < 0.05 ) .


The total effective rate of the two groups was 84 % and 66 % , respectively .


Zhenjingdingzhi decoction is effective and safe for the treatment of insomnia with Qi-deficiency of heart and gallbladder , especially for improving sleep quality and sleep duration .


To evaluate the efficacy and safety of aripiprazole versus placebo in preventing relapse of irritability symptoms associated with autistic disorder in pediatric patients .


This multicenter , double-blind , randomized , placebo-controlled , relapse-prevention trial enrolled patients ( 6-17 years ) who met the current Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , Text Revision ( DMS-IV-TR ) criteria for autistic disorder and who also had serious behavioral problems ( ie , tantrums , aggression , self-injurious behavior , or a combination of these behavioral problems ) between March 2011 and June 2012 .


In phase 1 , single-blind aripiprazole was flexibly dosed ( 2-15 mg/d ) for 13-26 weeks .


Patients with a stable response ( 25 % decrease in Aberrant Behavior Checklist-irritability subscale score and a rating of `` much improved '' or `` very much improved '' on the Clinical Global Impressions-Improvement scale ) for 12 consecutive weeks were randomized into phase 2 to continue aripiprazole or switch to placebo .


Treatment was continued until relapse or up to 16 weeks .


The primary end point was time from randomization to relapse .


Eighty-five patients were randomized in phase 2 .


The difference in time to relapse between aripiprazole and placebo was not statistically significant ( P = .097 ) .


Kaplan-Meier relapse rates at week 16 were 35 % for aripiprazole and 52 % for placebo ( hazard ratio [ HR ] = 0.57 ; number needed to treat [ NNT ] = 6 ) .


The most common adverse events during phase 1 were weight increase ( 25.2 % ) , somnolence ( 14.8 % ) , and vomiting ( 14.2 % ) ; and , during phase 2 ( aripiprazole vs placebo ) , they were upper respiratory tract infection ( 10.3 % vs 2.3 % ) , constipation ( 5.1 % vs 0 % ) , and movement disorder ( 5.1 % vs 0 % ) .


In this study , there was no statistically significant difference between aripiprazole and placebo in time to relapse during maintenance therapy .


However , the HR and NNT suggest some patients will benefit from maintenance treatment .


Patients receiving aripiprazole should be periodically reassessed to determine the continued need for treatment .


ClinicalTrials.gov identifier : NCT01227668 .


This preplanned subset analysis of the phase III MONET1 study aimed to determine whether motesanib combined with carboplatin/paclitaxel ( C/P ) would result in improved overall survival ( OS ) versus chemotherapy alone , in a subset of Asian patients with nonsquamous nonsmall-cell lung cancer ( NSCLC ) .


Patients with nonsquamous NSCLC ( stage IIIB/IV or recurrent ) and no prior systemic therapy for advanced disease were randomized to IV carboplatin ( AUC , 6 mg/ml min ) and paclitaxel ( 200 mg/m2 ) for up to six 3-week cycles , plus either oral motesanib 125 mg q.d. or placebo .


Primary end point was OS ; secondary end points included progression-free survival ( PFS ) , objective response rate ( ORR ) , and safety .


Two hundred twenty-seven Asian patients from MONET1 were included in this descriptive analysis .


Median OS was 20.9 months in the motesanib plus C/P arm and 14.5 months in the placebo plus C/P arm ( P = 0.0223 ) ; median PFS was 7.0 and 5.3 months , respectively , ( P = 0.0004 ) ; and ORR was 62 % and 27 % , respectively , ( P < 0.0001 ) .


Grade3 adverse events were more common in the motesanib plus C/P arm versus placebo plus C/P ( 79 % versus 61 % ) .


In this preplanned subset analysis of Asian patients with nonsquamous NSCLC , motesanib plus C/P significantly improved OS , PFS , and ORR versus placebo plus C/P .


NCT00460317 .


The model of Family group-conferencing ( FG-c ) for decision making in child welfare has rapidly spread over the world during the past decades .


Its popularity is likely to be caused by its philosophy , emphasizing participation and autonomy of families , rather than based on positive research outcomes .


Conclusive evidence regarding the ( cost ) effectiveness of FG-c is not yet available .


The aim of this protocol is to describe the design of a study to evaluate the ( cost ) effectiveness of FG-c as compared to Treatment as Usual .


The effectiveness of FG-c will be examined by means of a Randomized Controlled Trial .


A multi-informant approach will be used to assess child safety as the primary outcome , and commitment of the social network , perceived control / empowerment ; family functioning and use of professional care as secondary outcomes .


Implementation of FG-c , characteristics of family manager and family will be examined as moderators of effectiveness .


Studying the effectiveness of Fg-c is crucial now the method is being implemented all over the world as a decision making model in child and youth care .


Policy makers should be informed whether the ideals of participation in society and the right for self-determination indeed result in more effective care plans , and the money spent on FG-c is warranted .


Dutch Trial Register number NTR4320 .


The design of this study is approved by the independent Ethical Committee of the Faculty of Social and Behavioral Sciences of The University of Amsterdam ( approval number : 2013-POWL-3308 ) .


This study is financially supported by a grant from ZonMw , The Netherlands Organization for Health Research and Development , grant number : 70-72900-98-13158 .


Recent studies involving phototherapy applied prior to exercise have demonstrated positive results regarding the attenuation of muscle fatigue and the expression of biochemical markers associated with recovery .


However , a number of factors remain unknown , such as the ideal dose and application parameters , mechanisms of action and long-term effects on muscle recovery .


The aims of the proposed project are to evaluate the long-term effects of low-level laser therapy on post-exercise musculoskeletal recovery and identify the best dose andapplication power/irradiation time .


A double-blind , randomized , placebo-controlled clinical trial with be conducted .


After fulfilling the eligibility criteria , 28 high-performance athletes will be allocated to four groups of seven volunteers each .


In phase 1 , the laser power will be 200 mW and different doses will be tested : Group A ( 2 J ) , Group B ( 6 J ) , Group C ( 10 J ) and Group D ( 0 J ) .


In phase 2 , the best dose obtained in phase 1 will be used with the same distribution of the volunteers , but with different powers : Group A ( 100 mW ) , Group B ( 200 mW ) , Group C ( 400 mW ) and Group D ( 0 mW ) .


The isokinetic test will be performed based on maximum voluntary contraction prior to the application of the laser and after the eccentric contraction protocol , which will also be performed using the isokinetic dynamometer .


The following variables related to physical performance will be analyzed : peak torque/maximum voluntary contraction , delayed onset muscle soreness ( algometer ) , biochemical markers of muscle damage , inflammation and oxidative stress .


Our intention , is to determine optimal laser therapy application parameters capable of slowing down the physiological muscle fatigue process , reducing injuries or micro-injuries in skeletal muscle stemming from physical exertion and accelerating post-exercise muscle recovery .


We believe that , unlike drug therapy , LLLT has a biphasic dose-response pattern .


The protocol for this study is registered with the Protocol Registry System , ClinicalTrials.gov identifier NCT01844271 .


Patients with severe limb ischemia may not be eligible for conventional therapeutic interventions .


Pioneering clinical trials suggest that bone marrow-derived cell therapy enhances neovascularization , improves tissue perfusion , and prevents amputation .


The objective of this trial was to determine whether repetitive intra-arterial infusion of bone marrow mononuclear cells ( BMMNCs ) in patients with severe , nonrevascularizable limb ischemia can prevent major amputation .


The Rejuvenating Endothelial Progenitor Cells via Transcutaneous Intra-arterial Supplementation ( JUVENTAS ) trial is a randomized , double-blind , placebo-controlled clinical trial in 160 patients with severe , nonrevascularizable limb ischemia .


Patients were randomly assigned to repetitive ( 3 times ; 3-week interval ) intra-arterial infusion of BMMNC or placebo .


No significant differences were observed for the primary outcome , ie , major amputation at 6 months , with major amputation rates of 19 % in the BMMNC versus 13 % in the placebo group ( relative risk , 1.46 ; 95 % confidence interval , 0.62-3 .42 ) .


The safety outcome ( all-cause mortality , occurrence of malignancy , or hospitalization due to infection ) was not significantly different between the groups ( relative risk , 1.46 ; 95 % confidence interval , 0.63-3 .38 ) , neither was all-cause mortality at 6 months with 5 % versus 6 % ( relative risk , 0.78 ; 95 % confidence interval , 0.22-2 .80 ) .


Secondary outcomes quality of life , rest pain , ankle-brachial index , and transcutaneous oxygen pressure improved during follow-up , but there were no significant differences between the groups .


Repetitive intra-arterial infusion of autologous BMMNCs into the common femoral artery did not reduce major amputation rates in patients with severe , nonrevascularizable limb ischemia in comparison with placebo .


The general improvement in secondary outcomes during follow-up in both the BMMNC and the placebo group , as well , underlines the essential role for placebo-controlled design of future trials .


http://www.clinicaltrials.gov .


Unique identifier : NCT00371371 .


Folate and vitamin B-12 are important for growth .


Many children in low - and middle-income countries have inadequate intakes of these nutrients .


We undertook a randomized , placebo controlled double-blind trial in 1000 North Indian children , 6 to 35 months of age , providing twice the recommended daily allowance of folic acid and/or vitamin B-12 , or placebo , daily for 6 months .


By using a factorial design , we allocated children in a 1:1:1:1 ratio in blocks of 16 .


We measured the effect of giving vitamin B-12 , folic acid , or the combination of both on linear and ponderal growth .


We also identified predictors for growth in multiple linear regression models and effect modifiers for the effect of folic acid or vitamin B-12 supplementation on growth .


The overall effect of either of the vitamins was significant only for weight ; children who received vitamin B-12 increased their mean weight-for-age z scores by 0.07 ( 95 % confidence interval : 0.01 to 0.13 ) .


Weight-for-age z scores and height-for-age z scores increased significantly after vitamin B-12 supplementation in wasted , underweight , and stunted children .


These subgrouping variables significantly modified the effect of vitamin B-12 on growth .


Vitamin B-12 status at baseline predicted linear and ponderal growth in children not receiving vitamin B-12 supplements but not in those who did ( P-interaction < .001 ) .


We provide evidence that poor vitamin B-12 status contributes to poor growth .


We recommend studies with larger doses and longer follow-up to confirm our findings .


To evaluate the effectiveness of a single-session online theory of planned behaviour ( TPB ) - based intervention to improve sun-protective attitudes and behaviour among Australian adults .


Australian adults ( N = 534 ; 38.7 % males ; Mage = 39.3 years ) from major cities ( 80.9 % ) , regional ( 17.6 % ) and remote areas ( 1.5 % ) were recruited and randomly allocated to an intervention ( N = 265 ) and information only group ( N = 267 ) .


The online intervention focused on fostering positive attitudes , perceptions of normative support , and control perceptions for sun protection .


Participants completed questionnaires assessing standard TPB measures ( attitude , subjective norm , perceived behavioural control , intention , behaviour ) and extended TPB constructs of group norm ( friends , family ) , personal norm , and image norm , pre-intervention ( Time 1 ) and one week ( Time 2 ) and one month post-intervention ( Time 3 ) .


Repeated Measures Multivariate Analysis of Variance tested intervention effects across time .


Intervention participants reported more positive attitudes towards sun protection and used sun-protective measures more often in the subsequent month than participants receiving information only .


The intervention effects on control perceptions and norms were non-significant .


A theory-based online intervention fostering more favourable attitudes towards sun safety can increase sun protection attitudes and self-reported behaviour among Australian adults in the short term .


The efficacy and safety of amrubicin , a third-generation synthetic anthracycline , were evaluated by comparison with carboplatin/etoposide combination therapy in elderly Japanese patients with extensive-disease small-cell lung cancer ( ED-SCLC ) .


Eligibility included histologically or cytologically proven SCLC , no previous systemic chemotherapy , performance status of 0 to 2 , and age 70 years .


Patients received amrubicin ( 70-74 years old , 40-45 mg/m ( 2 ) ; 75 years old , 40 mg/m ( 2 ) ) intravenously on days 1 to 3 every 3 weeks for 4 to 6 cycles or carboplatin ( area under the curve of 5 intravenously on day 1 ) and etoposide ( 80 mg/m ( 2 ) intravenously on days 1 to 3 ) every 3 weeks for 4 to 6 cycles .


The target number of patients was 130 with 65 in each arm .


However , the study was terminated early owing to 3 treatment-related deaths in the amrubicin arm , and only 62 patients ( median age , 76 years ; range , 70-88 years ) were enrolled .


The characteristics of the patients in the amrubicin and carboplatin/etoposide arms did not differ significantly .


Overall survival , time to progression , and objective response rate were 10.9 vs. 11.3 months ( P = .7353 ) , 4.7 vs. 4.4 months , and 74.2 % ( 23 of 31 ) vs. 60.0 % ( 18 of 30 ) , respectively , and quality of life showed no significant difference between the 2 arms .


Higher incidences of febrile neutropenia and interstitial lung disease of grade 3 or worse occurred with amrubicin ( 34.4 % vs. 3.3 % and 12.5 % vs. 0 % , respectively ) .


These results indicate that amrubicin monotherapy at 40 to 45 mg/m ( 2 ) is toxic and intolerable in elderly Japanese patients with ED-SCLC .


Our aim was to investigate the acute and 24-hour ( h ) effects of high-intensity interval training ( HIIT ) and moderate continuous training ( MCT ) on arterial pulse wave reflection , an established marker of arterial stiffness and cardiovascular risk .


In a randomized cross-over design , 21 young healthy male participants performed a HIIT or a MCT on separate visits .


Before and 5 ( t5 ) , 20 ( t20 ) , 35 ( t35 ) , and 50 ( t50 ) minutes after the acute exercise bouts , the crude augmentation index ( AIx ) and the AIx at a set heart rate ( AIx@75 ) were analysed by applanation tonometry .


Starting 1h post-exercise , both indices were captured over 24-h with an oscillometric monitoring device .


AIx did not change significantly after MCT but declined progressively after HIIT , reaching significantly lower values compared to MCT at t35 ( P = 0.045 ) and t50 ( P = 0.008 ) .


AIx@75 increased after both acute exercise types but was higher after HIIT at t5 ( P < 0.001 ) , t20 ( P < 0.001 ) and t35 ( P = 0.009 ) compared to MCT .


The 24-h follow-up revealed a significant decline in AIx@75 after HIIT ( P = 0.007 ) but not after MCT ( P = 0.813 ) .


Exercise intensity affects pulse wave reflection , with different time courses for AIx and AIx@75 post-exercise .


Although initially higher after HIIT , AIx@75 declines in the 24-h recovery period indicating more favourable effects on pulse wave reflection compared to MCT .


This may result in substantial positive chronic training effects on arterial stiffness in health and cardiovascular disease .


To observe the differences in timely effectiveness of immediate analgesia on acute migraine between electroacupuncture ( EA ) at shaoyang meridian points and non-meridian points .


The randomized controlled trial method was adopted .


One hundred and ten cases of acute migraine were randomized into two groups .


55 cases in each one .


In the observation group , EA was applied to Fengchi ( GB 20 ) , Waiguan ( TE 5 ) , etc. .


In the control group .


EA was applied to non-meridian points .


Only one treatment was given , and the nee dies were retained for 30 min in the two groups .


Separately .


at 10 time points , named before acupuncture , in 5 min , 10 min .


20 min and 30 min ( at the moment of needle removal ) , 1 h , 2 h , 4 h , 6 h and 8 h after acupuncture , the pain intensity numerical rating scale ( PI-NRS ) was adopted to evaluate the pain severity and the adverse reac tion was recorded .


( 1 ) The effective rate of imnmediate analgesia was 87.3 % ( 48/55 ) in the observation group .


significantly higher than 52.7 % ( 29/55 ) in the control group ( P < 0.01 ) .


( 2 ) NRS of each group was re duced at each time point , from 5 min to 8 h after acupuncture ( all P < 0.01 ) .


( 3 ) NRS score at 30 min after acu puncture in the control group was obviously lower than that in the observation group ( P < 0.05 ) , but the scores in 2 h , 4 h , 6 h and 8 h after acupuncture in the observation group were lower apparently than those in the control group ( all P < 0.01 ) .


The differences in the scores in 5 min , 10 min , 20 min and 1 h after acupuncture were not significant ( all P > 0.05 ) .


( 4 ) For the reducing amplitude of NRS score at the same time point after acupuncture , the results in 20 min , 30 min and 1 h in the control group were higher apparently than those in the observation group ( all P < 0.05 ) .


But , in 2 h , 4 h , 6 h and 8 h , the results in the observation group were higher apparently than those in the control group ( all F < 0.05 ) .


The differences in 5 min and 10 min after acupuncture were not significant ( both P > 0.05 ) .


( 5 ) In 24 h after acupuncture , the recurrence rate of migraine was 12.7 % ( 7/55 ) in the observation group , which was lower obviously than 34.5 % ( 19/55 ) in the control group ( P < 0.05 ) .


The adverse reaction was not found in the two groups .


EA at the shaoyang meridian points achieves the definite immediate analgesia effect on acute migraine and presents the time effectiveness of analgesia .


This study aimed to assess the effectiveness of a blended-teaching intervention using Internet-based tutorials coupled with traditional lectures in an introduction to research undergraduate nursing course .


Effects of the intervention were compared with conventional , face-to-face classroom teaching on three outcomes : knowledge , satisfaction , and self-learning readiness .


A two-group , randomized , controlled design was used , involving 112 participants .


Descriptive statistics and analysis of covariance ( ANCOVA ) were performed .


The teaching method was found to have no direct impact on knowledge acquisition , satisfaction , and self-learning readiness .


However , motivation and teaching method had an interaction effect on knowledge acquisition by students .


Among less motivated students , those in the intervention group performed better than those who received traditional training .


These findings suggest that this blended-teaching method could better suit some students , depending on their degree of motivation and level of self-directed learning readiness .


Vessel wall injury after drug-eluting stent ( DES ) implantation can be characterized in detail by optical coherence tomography ( OCT ) .


Little is known about the healing course of these phenomena .


In 62 lesions ( 62 patients ) , the incidence of acute vessel trauma was assessed in the stented region and the edge segments immediately after DES implantation .


The healing course of these injuries was assessed at 9-month OCT follow-up using a software algorithm allowing for reliable spatial comparison of baseline and follow-up cross-sectional images .


Tissue prolapse ( TP ) and tissue protrusions were detected in 81 and 35 % of lesions , respectively .


A total of 342 intra-stent dissection flaps ( ISD ) and 114 intra-stent dissection cavities ( ISC ) were visualized in 98 and 81 % of lesions , respectively .


Thirty-five lesions ( 56 % ) showed edge dissections ( EDs ) .


No residual TP or protrusion was observed at follow-up .


Incomplete healing was seen in 8 % of ISD and in 20 % of ISC .


For ED , a residual flap was observed in one-third of the initially dissected stent edges .


Incomplete healing of acute vessel injury was associated with the presence of underlying atherosclerotic disease at baseline .


Uncovered and malapposed stent struts were observed more often with incomplete healing of vessel injury at follow-up .


Acute vessel wall trauma is highly prevalent immediately after DES implantation .


Most of these injuries are minor and resolve at mid-term follow-up .


Incomplete healing of ISDs seems to be associated with other OCT findings suggesting delayed arterial healing .


We hypothesized that integrated motor-visual functions measured by manipulative manual dexterity are affected by white matter lesion ( WML ) burden as measured on cranial MRI across relevant brain regions in subjects at risk of preclinical occult vascular disease .


A real-time cross-sectional study of healthy subjects aged 29 to 74 years with a family history of early-onset coronary artery disease ( n = 714 ; mean age , 51 11 years ; mean education , 14 3 years ; 42 % male ; 38 % black ) were identified from probands with coronary artery disease diagnosed before age 60 years .


WMLs on 3-tesla brain MRI and Grooved Pegboard scores were measured .


WMLs were observed at all ages .


Mean pegboard scores were 108 18 , similar to normal populations .


In unadjusted analysis , WMLs and pegboard scores were significantly correlated by region ( total WMLs , r = 0.34 , p = 0.0001 ; frontal [ r = 0.34 , p < 0.0001 ] , insula [ r = 0.31 , p < 0.0001 ] , parietal [ r = 0.31 , p < 0.0001 ] , and temporal [ r = 0.17 , p < 0.0001 ] ) .


In multivariate analysis predicting ( log ) pegboard score adjusted for age , sex , race , education , regional or total volumes , and familial non-independence , total WML volume ( p = 5.79 E - 05 ) and regional WML volumes ( p < 0.01 ) retained statistical significance in all but the youngest age quartile ( 29-43 years ) .


Greater WML volumes in different brain regions are associated with higher pegboard scores ( worse performance ) independent of age , sex , race , education , and total or regional volumes .


This suggests that small vessel cerebrovascular disease may be present in healthy individuals in a preclinical state with measurable impact on complex integrative functions in individuals with excess risk of clinical vascular disease .


We examined the durability of the virological response after discontinuing lamivudine ( LVD ) in chronic hepatitis B ( CHB ) patients with LVD-resistant hepatitis B virus ( HBV ) , who responded to LVD plus adefovir ( ADV ) combination therapy , and the outcome of switching to ADV monotherapy compared to maintaining combination therapy .


This study enrolled 72 patients with undetectable viral loads ( 12 IU/ml ) and normal alanine aminotransferase levels after ADV add-on therapy for at least 6 months in LVD-resistant CHB patients .


The enrolled patients were randomly assigned to continue with LVD-ADV combination therapy or switch to ADV monotherapy ( n = 36 per group ) .


Virological rebound was defined as HBV DNA detection at more than 12 IU/ml by quantitative polymerase chain reaction determined on two consecutive measurements .


During 96 weeks of follow-up , 100 % ( 36/36 ) of the patients in the LVD-ADV combination maintained group had persistently undetectable HBV DNA , compared with 94.4 % ( 34/36 ) patients in the ADV monotherapy switched group .


These two patients had undetectable HBV DNA after switching back to LVD-ADV combination therapy .


There were no significant differences in the HBsAg levels between the two treatment groups during the 96-week follow-up period .


In our study , switching to ADV monotherapy resulted in sustained HBV DNA suppression in 94.4 % of the patients for 96 weeks .


Prior complete viral suppression with LVD-ADV combination therapy conferred a significant advantage in patients who switched to ADV monotherapy .


LVD may be discontinued in patients who show a complete virological response to LVD-ADV combination therapy for at least 6 months .


Rapid travel over multiple time zones usually results in transient de-synchronization between environmental time and the biological clock of the individual .


Common symptoms are increased daytime sleepiness , reduced sleep duration and quality , and performance impairments .


Exposure to ocular bright light is known to alleviate jet lag symptoms and facilitate adaptation to a new time zone .


Recently , transcranial bright light ( TBL ) via the ear canals has been shown to have antidepressant , anxiolytic , and psychomotor performance-enhancing effects .


In this case we studied whether intermittent TBL exposure can alleviate jet lag symptoms in a randomized , double-blind , placebo-controlled study .


Intermittent light exposures ( 4 12 min ; day 0 : 08:00 , 10:00 , 12:00 , 14:00 ; days 1-6 : 10:00 , 12:00 , 14:00 , 16:00 ) were administered during the 7-d post-travel period after an eastward transatlantic flight .


The symptoms of jet lag were measured by the Visual Analog Scale ( VAS ) , the Karolinska Sleepiness Scale ( KSS ) , and the Profile of Mood States ( POMS ) .


We found a significant reduction of overall jet lag symptoms ( VAS ) , subjective sleepiness ( KSS ) , and the fatigue , inertia , and forgetfulness subscales of the POMS when comparing the active TBL treatment group ( N = 30 ) to the placebo group ( N = 25 ) .


For example , the normalized values of VAS in the TBL , but not the placebo , group returned to pre-travel levels by the final post-travel day ( 6.16 vs. 15.34 ) .


Results suggest a cumulative effect of TBL , as the effects emerged on post-travel days 3-4 .


Intermittent TBL seems to alleviate jet lag symptoms .


To explore the effects of penehyclidine inhalation on the incidence of pulmonary complications in elderly patients after long-duration surgery .


For this prospective , double-blind and randomized controlled trial , 90 elderly patients undergoing long-duration surgery ( 3 hours ) under general anesthesia and transferred into intensive care unit ( ICU ) of Peking University First Hospital during February 14 , 2012 to September 13 , 2012 were enrolled .


After extubation , they were randomized into 3 groups to receive an inhalation of penehyclidine hydrochloride , ipratropium bromide or normal saline for 3 consecutive days .


The primary endpoint was the incidence of pulmonary complications within 6 days post-extubation .


The incidence of bronchospasm was 3.3 % , 3.2 % and 20.7 % respectively .


And the rate of aminophylline use was 0,0 and 10.3 % respectively ( P = 0.025 and P = 0.038 ) ; the airway tract spasm-free duration within 6 days after extubation was 5.8 ( 5.5-6 .2 ) , 5.8 ( 5.5-6 .2 ) and 5.3 ( 4.8-5 .9 ) days ( P = 0.028 ) ; the overall incidence of pulmonary complications was 70.0 % , 71.0 % and 75.9 % ( P = 0.865 ) .


For elderly patients after long-duration surgery , a prophylactic atomizing inhalation of penehyclidine decreases the incidence of bronchospasm and the rate of aminophylline use after extubation.However , the overall incidence of pulmonary complications has no change .


Offering the overweight or obese patient the option of choosing from a selection of weight loss diets has not been investigated in type 2 diabetes .


The aim of the study was to investigate if the option to choose from , and interchange between a selection of diets ( `` Choice '' ) , as opposed to being prescribed one set diet ( `` No Choice '' ) , improves drop out rates and leads to improved weight loss and cardio-metabolic outcomes .


The study was a 12month , randomized parallel intervention .


A total of 144 volunteers with type 2 diabetes or pre-diabetes and a BMI > 27 were randomized to `` No Choice '' or `` Choice '' .


Those in the No Choice group were placed on a set weight loss diet ( CSIRO ) with no change permitted .


Those in the Choice group could choose from , and interchange between , the CSIRO , South Beach or Mediterranean diets .


There were no differences in attrition rates or weight loss between the `` Choice '' and `` No Choice '' .


In a secondary analysis of the intention-to-treat weight loss data with last measured weight carried forward gave a highly significant diet group by time by gender interaction ( p = 0.002 ) with men doing better in the No Choice group overall ( maximum difference `` No Choice '' -2.94.6 kg vs. `` Choice '' -6.2 kg5 .3 kg at 6months ) and women doing better in the Choice group overall ( maximum difference Choice -3.13.7 kg vs. `` No Choice '' -2.0 kg2 .6 kg at 6months ) .


Men prefer direction in their weight loss advice and do less well with choice .


A gender-specific approach is recommended when prescribing weight loss diets .


anzctr.org.au ACTRN12612000310864 .


To determine if the location of neodymium : yttrium-aluminum-garnet laser peripheral iridotomy ( LPI ) is related to the occurrence of postoperative visual dysphotopsia .


Randomized , prospective , single-masked , paired-eye comparative clinical trial .


setting : Private subspecialty clinic in Mississauga , Canada .


study population : Patients with primary angle closure or primary angle-closure suspects were recruited and randomized to receive LPI temporally in one eye and superiorly in the other .


Patients were masked to the location of treatment in each eye .


intervention : Temporal or superior LPI .


main outcome measures : Occurrence of new-onset linear dysphotopsia .


Other visual disturbances also were assessed using a questionnaire before and 1month after intervention .


Secondary outcome measures included eyelid position , laser parameters , and any intraoperative complications .


A total of 208 patients were recruited to the study , of which 169 ( 84 % ) completed it .


New-onset linear dysphotopsia was reported in 18 ( 10.7 % ) eyes with superior LPI versus 4 ( 2.4 % ) eyes with temporal LPI ( P = .002 ) .


Eleven eyes ( 6.5 % ) with superior LPI reported linear dysphotopsia despite complete eyelid coverage of the iridotomy .


No significant differences were found with other visual disturbances between them .


There was more pain experienced by the temporal LPI ( 2.8 2.2 vs 2.1 2.0 ; P = .001 ) , despite no difference in laser energy or number of shots .


Intraoperative rates of hemorrhage were similar ( 8.9 % vs 10.1 % ; P = .71 ) .


Temporal placement of LPI is safe and was found to be less likely to result in linear dysphotopsia as compared with superior placement .


Temporal iris therefore may be considered a preferred location for LPI .


To examine the functional status ( mental health , academic performance , peer problems ) of a community-based sample of children who have attention-deficit/hyperactivity disorder ( ADHD ) and non-ADHD controls , and to investigate gender and subtype differences .


Children aged 6 to 8 years were recruited through 43 Melbourne schools , using a 2-stage screening ( parent and teacher Conners 3 ADHD index ) and case confirmation ( Diagnostic Interview Schedule for Children , Version IV ; [ DISC-IV ] ) procedure .


Outcome measures were mental health disorders ( DISC-IV ) , academic performance ( Wide Range Achievement Test 4 ) , and peer problems ( Strength and Difficulties Questionnaire ) .


Unadjusted and adjusted linear and logistic regression were used to compare ADHD and non-ADHD controls .


A total of 179 children who have ADHD and 212 non-ADHD controls were recruited .


Compared with controls , children who had ADHD had higher odds of externalizing ( odds ratio [ OR ] , 11.0 ; 95 % confidence interval [ CI ] , 5.6-21 .6 ; P < .001 ) and internalizing ( OR , 2.9 ; 95 % CI , 1.2-7 .2 ; P = .02 ) disorders ; poorer reading ( effect size , -0.66 ) and mathematics ( effect size , -0.69 ) performance ; and more peer problems ( P < .001 ) .


Boys and girls who had ADHD were equally impaired .


Only 17 % of children in our ADHD group had been previously diagnosed .


Previous diagnosis was higher in the Combined group and for boys .


In their second year of school , children who had ADHD performed worse than controls across all functional domains , yet only a minority had been formally diagnosed with ADHD .


Findings highlight the need for earlier diagnosis and intervention .


Assessment of symptoms and rescue medication use are well-established endpoints for clinical trials evaluating asthma treatment .


To evaluate the measurement properties of an asthma symptom and rescue medication use ( ASRMU ) diary for clinical trials involving asthma patients aged 12 years .


Interviews with 35 patients were conducted to confirm the importance of key concepts in the ASRMU diary .


Scores of symptom and rescue medication use were converted to symptom-free days ( SFD ) and rescue-free days ( RFD ) .


Test-retest reliability and equivalence ( based on intra-class correlation coefficients [ ICCs ] ) between paper-and-pencil and electronic ( eDiary ) versions were evaluated in a prospective study in 47 patients .


Responsiveness of the ASRMU diary was evaluated through differences in percentage of SFD and of RFD by treatment group in eight asthma clinical trials that assessed inhaled corticosteroids ( ICS ) and long-acting 2-agonists ( LABA ) , alone or in combination .


A ninth placebo-controlled study calculated effect sizes .


Minimal important differences ( MID ) were determined using anchor-based methods from two trials and by interviewing 11 patients .


Patient interviews supported content validity for the ASRMU diary .


Test-retest reliability was acceptable for SFD ( ICC :0.70 -0.75 ) , but varied for RFD ( ICC :0.58 -0.78 ) .


Paper-and-pencil and eDiary modes of administration were equivalent ( SFD , ICC = 0.84 ; RFD , ICC = 0.70 ) .


ICS/LABA had the largest percentage of SFD and RFD , followed by monotherapy and then placebo .


MIDs were 7.7-14 .7 % for SFD and 8.4-15 .6 % for RFD .


The ASRMU diary captures the disease-specific concepts of greatest importance to asthma patients and provides important information for asthma diagnosis and treatment evaluation .


To evaluate the effect of microecologic treatment combined enteral nutrition on serum endotoxin , tumor necrosis factor - ( TNF - ) , interleukin-18 ( IL-18 ) , blood ammonia levels and nutritional status in patients with hepatic encephalopathy .


60 patients with hepatic encephalopathy were allocted randomly into 3 groups , on the basis of conventional liver protective therapy and uragogue with one group given probiotics plus enteral nutrition , one given probiotics only , and the 3rd group given intravenous nutrition .


The whole course of treatment was four weeks .


Serum levels of endotoxin , TNF - , IL-18 , ammonia and albumin were determined before and on the 7th and 14th day after treatment .


The levels of serum endotoxin , TNF - , IL-18 and blood ammonia in the combined treatment group decreased remarkably after treatment , while the level of serum albumin elevated markedly .


The difference was significant at statistics as compared with the only probiotics group and intravenous nutrition group ( P < 0.05 ) .


Microecologic treatment combined enteral nutrition could effectively reduce blood ammonia and serum endotoxin levels , protect intestinal mucosal barrier , as well as improve nutritional status of patients with hepatic encephalopathy , which was considered as a safe and efficient therapy .


The aim of this study was to determine if the timing of intra-articular local anesthetic injection and the status of the suction drain affect variable pain scores after ACL reconstruction .


The study included 40 patients undergoing arthroscopic ACL reconstruction randomized into 4 groups .


Patients in Group 1 received intra-articular 20 ml of 0.25 % bupivacaine 20 minutes before the start of the operation ( preemptive : PE ) , Group 2 at the end of the operation with the suction drain opened ( DO ) .


Group 3 also received intra-articular bupivacaine at the end of the operation and the drain was kept closed for one hour postoperatively ( DC ) .


Group 4 did not receive any intra-articular injection ( control group : CG ) and served as the control group .


Visual analog scale ( VAS ) scores and additional analgesic requirements were recorded .


The PE group had the lowest and the control group the highest VAS scores at the second postoperative hour .


At the fourth postoperative hour , VAS scores were significantly higher in the DC group than the DO group ( p < 0.05 ) .


At the sixth postoperative hour , the PE and DC groups had significantly lower VAS scores than the other groups ( p < 0.05 ) .


At Hour 12 , the PE and control groups had higher VAS scores than the DO and DC groups .


VAS scores were not different among groups at Hour 24 .


The interval to first analgesic requirement was significantly shorter in the control group and longer in the PE group in comparison to the other two groups ( p < 0.001 ) .


Intra-articular bupivacaine injection at different stages of the operation yielded variable VAS scores in the postoperative period .


Closing the drain after intra-articular injection resulted in an early onset analgesic effect without shortening the duration .


To investigate the prevention of diarrhea by oral BIFICO for infants aged 1-6 years .


490 cases of infants were randomly divided after age stratification : the experimental group ( n = 247 ) and the control group ( n = 243 ) .


Based on principles of randomized double-blind and placebo-controlled , the infants were given BIFICO ( dedicated clinical research ) therapy for 4 consecutive days , then observed for 21 days .


25 days composed a cycle .


They were observed total 5 cycles .


During the study period , principles for `` the diarrhoea patients must be detected '' , follow-up visited the participant infants and conducted etiology detection by way of sampling for diarrhea infants .


Evaluate the prevention efficacy of diarrhea by oral BIFICO for infants aged 1-6 years .


A total of 480 completed all study .


120 and 95 infants in the control group and experimental group were detected with diarrhea .


The incidence of diarrhea was 50.85 % and 38.93 % in these two guoup , respectively .


The difference has statistical significance ( chi2 = 4.175 , P = 0.041 ) .


In the third observation period , the infants in the control group had a higer incidence of diarrhea compared with which in the experimental group ( chi2 = 4.415 , P = 0.036 ) .


14 strains of rotavirus , 3 strains of norovirus , 3 strains of sappovirus , 2 strains of adenovirus , 5 strains of salmonella and 4 strains of Shigella were check out in 128 samples .


Oral BIFICO can paly certain preventive role on diarrhea , and decrease the incidence of diarrhea in infants aged 1-6 years .


To evaluate whether electroacupuncture ( EA ) at ST36 can accelerate the recovery of gastrointestinal motility after colorectal surgery .


Forty patients of American Society of Anesthesiologists physical status II and III undergoing elective open resection of malignant colorectal tumours were included in this study .


Using a sealed envelope method , the patients were randomly divided into two groups either receiving EA ( EA group ) or sham EA ( SEA group ) .


Data regarding the recovery of bowel function ( times to the first bowel sounds , passage of flatus and defaecation ) were collected and analysed .


In the EA group , the time intervals from surgery to the first bowel movement and passage of flatus were shorter than in the SEA group ( 1310h vs 1913h , p < 0.05 and 2314h vs 3218h , p < 0.05 , respectively ) .


There was no significant difference between the groups regarding the time to first defaecation ( 6845h vs 7253h , p > 0.05 ) .


EA at ST36 accelerates the recovery of gastrointestinal motility after colorectal surgery .


JJ22011-15 .


Medication non-adherence is considered an important cause of morbidity and mortality in primary care .


This study aims to determine the effectiveness , cost effectiveness and acceptability of a complex intervention delivered by community pharmacists , the New Medicine Service ( NMS ) , compared with current practice in reducing non-adherence to , and problems with , newly prescribed medicines for chronic conditions .


Research subject group : patients aged 14 years and above presenting in a community pharmacy for a newly prescribed medicine for asthma/chronic obstructive pulmonary disease ( COPD ) ; hypertension ; type 2 diabetes or anticoagulant/antiplatelet agents in two geographical regions in England .


parallel group patient-level pragmatic randomized controlled trial .


patients randomized to either : ( i ) current practice ; or ( ii ) NMS intervention comprising pharmacist-delivered support for a newly prescribed medicine .


proportion of adherent patients at six , ten and 26 weeks from the date of presenting their prescriptions at the pharmacy ; cost effectiveness of the intervention versus current practice at 10 weeks and 26 weeks ; in-depth qualitative understanding of the operationalization of NMS in pharmacies .


impact of NMS on : patients ' understanding of their medicines , pharmacovigilance , interprofessional and patient-professional relationships and experiences of service users and stakeholders.Economic analysis : Trial-based economic analysis ( cost per extra adherent patient ) and long-term modeling of costs and health effects ( cost per quality-adjusted-life-year ) will be conducted from the perspective of National Health Service ( NHS ) England , comparing NMS with current practice.Qualitative analysis : a qualitative study of NMS implementation in different community settings , how organizational influences affect NMS delivery , patterns of NMS consultations and experiences of professionals and patients participating in NMS , and patients receiving current practice .


250 patients in each treatment arm would provide at least 80 % power ( two-tailed alpha of 0.05 ) to demonstrate a reduction in patient-reported non-adherence from 20 % to 10 % in the NMS arm compared with current practice , assuming a 20 % drop-out rate .


At the time of submission of this article , 58 community pharmacies have been recruited and the interventions are being delivered .


Analysis has not yet been undertaken .


Current controlled trials : ISRCTN23560818 .


Clinical Trials US ( clinicaltrials.gov ) : NCT01635361 .


To observe the clinical efficacy difference in the treatment of neonatal hypoxic ischemic encephalopathy ( NHIE ) between the combined therapy of acupuncture land acupoint injection of nerve growth fac-tor ( NGF ) and the combined therapy of the intravenous drop of citicoline sodium and intramuscular injection of NGF .


Sixty-one cases of NHIE were randomized into an observation group ( 32 cases ) and a control group ( 29 cases ) .


In the observation group , acupuncture combined with acupint injection of NGF was adopted .


The acupoints were Baihui ( GV 20 ) , Dazhui ( GV 14 ) and Fengfu ( GV 16 ) , 0.5 mL each acupoint , once a day .


In the control group , the intravenous drop of citicoline sodium and intramuscular injection of NGF were used .


The , treatment of 7 days made one session and 3 sessions were required .


Separately , in 7 , 14 and 21 days of treatment , the clinical efficacy , behavior nerve determination score and adverse reaction were observed in the two groups .


In 7 , 14 and 21 days of treatment , the total effective rates were 50.0 % ( 16/32 ) , 68.8 % ( 22/32 ) and 78.1 % ( 25/32 ) in the observation group and were 69.0 % ( 20/29 ) , 72.4 % ( 21/29 ) and 82.8 % ( 24/29 ) in the control group .


The result in the control group was better than that in the observation group in the 7 days ( P < 0.05 ) .


The behavior determination scores in 7 , 14 and 21 days were all improved obviously as compared with those before treatment in the two groups ( P < 0.05 , P < 0.01 ) .


The score in the control group was better than that in the , observation group in the 7 days ( P < 0.05 ) .


The differences were not significant in the scores between the two groups in 14 and 21 days ( both P > 0.05 ) .


The incidence of adverse reaction in the observation group was lower than that in , the control group [ 14.3 % ( 5/35 ) vs 31.4 % ( 11/35 ) , P < 0.05 ] and the severity was mild .


In the treatment of NHIE with the combined therapy of acupuncture and acupint injection , the overall efficacy in 1 week ; is inferior to that of the combined therapy of the intravenous drop of citicoline sodium and intramuscular injection of NGF .


But the efficacy is improved gradually along with the treatment progression and the adverse reaction is less .


Eventual control of HIV/AIDS is believed to be ultimately dependent on a safe , effective and affordable vaccine .


Participation of sub-Saharan Africa in the conduct of HIV trials is crucial as this region still experiences high HIV incidences .


We describe the experience of recruiting and retaining volunteers in the first HIV vaccine trial ( HIVIS03 ) in Tanzania .


In this trial enrolled volunteers from amongst Police Officers ( POs ) in Dar es Salaam were primed with HIV-1 DNA vaccine at months 0 , 1 and 3 ; and boosted with HIV-1 MVA vaccine at months 9 and 21 .


A stepwise education provision/sensitization approach was employed to eventual recruitment .


Having identified a `` core '' group of POs keen on HIV prevention activities , those interested to participate in the vaccine trial were invited for a first screening session that comprised of provision of detailed study information and medical evaluation .


In the second screening session results of the initial assessment were provided and those eligible were assessed for willingness to participate ( WTP ) .


Those willing were consented and eventually randomized into the trial having met the eligibility criteria .


Voluntary participation was emphasized throughout .


Out of 408 POs who formed the core group , 364 ( 89.0 % ) attended the educational sessions .


263 out of 364 ( 72.2 % ) indicated willingness to participate in the HIV vaccine trial .


98 % of those indicating WTP attended the pre-screening workshops .


220 ( 85.0 % ) indicated willingness to undergo first screening and 177 POs attended for initial screenings , of whom 162 ( 91.5 % ) underwent both clinical and laboratory screenings .


119 volunteers ( 73.5 % ) were eligible for the study .


79 were randomized into the trial , while 19 did not turn up , the major reason being partner/family advice .


60 volunteers including 15 females were recruited during a one-year period .


All participated in the planned progress updates workshops .


Retention into the schedule was : 98 % for the 3 DNA/placebo vaccinations , while it was 83 % and 73 % for the first and second MVA/placebo vaccinations respectively .


In this first HIV vaccine trial in Tanzania , we successfully recruited the volunteers and there was no significant loss to follow up .


Close contact and updates on study progress facilitated the observed retention rates .


ISRCTN90053831 ISRNCT01132976 and ATMR2009040001075080 .


The GeparQuinto study showed that adding bevacizumab to 24 weeks of anthracycline-taxane-based neoadjuvant chemotherapy increases pathological complete response ( pCR ) rates overall and specifically in patients with triple-negative breast cancer ( TNBC ) .


No difference in pCR rate was observed for adding everolimus to paclitaxel in nonearly responding patients .


Here , we present disease-free ( DFS ) and overall survival ( OS ) analyses .


Patients ( n = 1948 ) with HER2-negative tumors of a median tumor size of 4 cm were randomly assigned to neoadjuvant treatment with epirubicin/cyclophosphamide followed by docetaxel ( EC-T ) with or without eight infusions of bevacizumab every 3 weeks before surgery .


Patients without clinical response to EC Bevacizumab were randomized to 12 weekly cycles paclitaxel with or without everolimus 5 mg/day .


To detect a hazard ratio ( HR ) of 0.75 ( = 0.05 , = 0.8 ) 379 events had to be observed in the bevacizumab arms .


With a median follow-up of 3.8 years , 3-year DFS was 80.8 % and 3-year OS was 89.7 % .


Outcome was not different for patients receiving bevacizumab ( HR 1.03 ; P = 0.784 for DFS and HR 0.974 ; P = 0.842 for OS ) compared with patients receiving chemotherapy alone .


Patients with TNBC similarly showed no improvement in DFS ( HR = 0.99 ; P = 0.941 ) and OS ( HR = 1.02 ; P = 0.891 ) when treated with bevacizumab .


No other predefined subgroup ( HR + / HER2 - ; locally advanced ( cT4 or cN3 ) or not ; cT1-3 or cT4 ; pCR or not ) showed a significant benefit .


No difference in DFS ( HR 0.997 ; P = 0.987 ) and OS ( HR 1.11 ; P = 0.658 ) was observed for nonearly responding patients receiving paclitaxel with or without everolimus overall as well as in subgroups .


Long-term results , in opposite to the results of pCR , do not support the neoadjuvant use of bevacizumab in addition to an anthracycline-taxane-based chemotherapy or everolimus in addition to paclitaxel for nonearly responding patients .


NCT 00567554 , www.clinicaltrials.gov .


It is still inconclusive whether chronic hepatitis B ( CHB ) patients with persistently normal alanine aminotransferase ( PNALT ) should receive nucleoside/nucleotide analogues .


This study is to evaluate the efficacy of entecavir in improving liver histology in CHB patients with PNALT .


In this prospective randomized , double-blind , placebo-controlled study , 380 CHB patients with PNALT were screened , 82 patients received biopsy and 43 patients met the HBV DNA and histology criteria and were randomly assigned to either an entecavir or placebo group for 52 weeks , with 22 and 21 in each group , respectively .


The primary objective was to evaluate histological improvement .


The secondary objective is to evaluate virological efficacy .


A total of eight ( 38.1 % ) patients in the entecavir group and eight ( 44.4 % ) in the placebo group ( P = 0.752 ) showed histological improvement .


The decrease in total Knodell scores ( sd ) was 1.3 1.9 in the entecavir group and 1.5 2.2 in the placebo group ( P = 0.803 ) .


The subjects with undetectable HBV DNA at week 52 were 16/21 ( 76.2 % ) in the entecavir group and 0/18 ( 0 % ) in the placebo group ( P < 0.001 ) .


The mean HBV DNA reduction from baseline to week 52 was 4.73 0.83 in the entecavir and 0.25 0.81 in the placebo group ( P < 0.001 ) .


CHB patients with PNALT receiving entecavir therapy for one year achieved virological efficacy , but not histological benefit .


ClinicalTrials.gov number NCT01833611 .


The aims of this study were to evaluate correlates and predictors of life functioning and quality of life in bipolar disorder during a comparative effectiveness trial of moderate doses of lithium .


In the Lithium treatment moderate-dose use study ( LiTMUS ) , 283 symptomatic outpatients with bipolar disorder type I or II were randomized to receive lithium plus `` optimal personalized treatment ( OPT ) '' , or OPT alone .


Participants were assessed using structured diagnostic interviews , clinician-rated blinded assessments , and questionnaires .


We employ linear mixed effects models to test the effect of treatment overall and adjunct lithium specifically on quality of life or functioning .


Similar models are used to examine the association of baseline demographics and clinical features with quality of life and life functioning .


Quality of life and impaired functioning at baseline were associated with lower income , higher depressive severity , and more psychiatric comorbid conditions .


Over 6 months , patients in both treatment groups improved in quality of life and life functioning ( p-Values < 0.0001 ) ; without a statistically significant difference between the two treatment groups ( p-Values > 0.05 ) .


Within the lithium group , improvement in quality of life and functioning was not associated with concurrent lithium levels at week 12 or week 24 ( p-Values > 0.05 ) .


Lower baseline depressive severity and younger age of onset predicted less improvement in functioning over 6 months .


Optimized care for bipolar disorder improves overall quality of life and life functioning , with no additional benefit from adjunct moderate doses of lithium .


Illness burden and psychosocial stressors were associated with worse quality of life and lower functioning in individuals with bipolar disorder .


To assess the accuracy of guided surgery ( mucosa and bone-supported ) compared to mental navigation or the use of a surgical template , in fully edentulous jaws , in a randomized controlled study .


Fifty-nine patients ( 72 jaws ) , requiring four to six implants ( maxilla or mandible ) , were consecutively recruited and randomly assigned to one of the following treatment groups ; guidance via Materialise Universal ( ) / mucosa , Materialise Universal ( ) / bone , Facilitate/mucosa , Facilitate/bone , or mental navigation or a pilot-drill template .


The precision was assessed by matching the planning computed tomography ( CT ) with a post-operative cone beam CT. .


A significant lower mean deviation at the entry point ( 1.4 mm , range : 0.3-3 .7 ) , at the apex ( 1.6 mm , range : 0.2-3 .7 ) and angular deviation ( 3.0 , range : 0.2-16 ) was observed for the guiding systems when compared to mental navigation ( 2.7 mm , range : 0.3-8 .3 ; 2.9 mm , range : 0.5-7 .4 and 9.9 , range : 1.5-27 .8 ) and to the surgical template group ( 3.0 mm , range : 0.6-6 .6 ; 3.4 mm , range : 0.3-7 .5 and 8.4 , range : 0.6-21 .3 ) .


Differences between bone and mucosa support or type of guidance were negligible .


Jaw and implant location ( posterior-anterior , left-right ) , however , had a significant influence on the accuracy when guided .


Based on these findings , guided implant placement appears to offer clear accuracy benefits .


In this study , the impact of quetiapine fumarate extended release ( QXR ) and escitalopram ( ESC ) on HPA axis activity was investigated in depressed patients in relationship to antidepressant efficacy .


In a randomized , open-label 5-week trial 60 inpatients suffering from major depression ( DSM-IV criteria ) were treated for 5 weeks with either QXR ( 300 mg/day ) or ESC ( 10mg/day ) .


The dexamethasone/CRH ( DEX/CRH ) test was performed before treatment , after 1 , and after 5 weeks of treatment .


Cortisol ( COR ) AUC values were used to assess HPA axis function .


The Hamilton Depression Rating Scale was used weekly to estimate antidepressant efficacy .


QXR and ESC showed comparable antidepressant effects but strongly differed in their impact on HPA axis activity .


In the QXR group , a marked inhibition of COR AUC levels was observed which was most pronounced after one week of treatment but showed a partial re-increase after 5 weeks of treatment .


In contrast , ESC transiently stimulated COR AUC values ( week 1 ) whereas COR AUC levels at week 0 and week 5 were comparable .


COR improvement at week 1 ( defined as COR peak value reduction between DEX/CRH test 1 and 2 ) was significantly associated with better clinical outcome .


Apparently , different effects on HPA axis activity reflect distinct pharmacoendocrinological properties of psychotropic drugs .


Several studies indicate that increasing the alimentary limb length in gastric bypass surgery produces only a minor improvement of excess BMI loss .


Few studies have addressed the efficacy of increasing the length of the pancreatico-biliary limb .


Here , we present a prospective randomized study of 187 consecutive laparoscopic Roux-Y gastric bypass operations operated over 2 years ( 2004-2005 ) in Iceland .


The patients were operated with a gastric bypass with either a 2-m biliopancreatic ( BP ) - limb and a 60-cm alimentary ( A ) - limb ( n = 93 ) or with a 150-cm A-limb and a 60-cm BP-limb ( n = 94 ) .


Preoperative median BMI was 44.1 ( 38-70 ) , median age 35.5 ( 17-74 ) years , and 85 % of the patients were female .


Follow-up rate after 5 years was 85 % .


Eighteen months following surgery , the weight loss was significantly higher in the BP-limb group ( p < 0.001 ) , and this difference remained 7 years after surgery .


Weight regain occurred in both groups , and 7 years after surgery , excess BMI loss ( EBMIL ) was 78.4 % in the BP-limb group compared to 67.1 % in the A-limb group ( p < 0.001 ) .


Most patients ( 78 % ) needed supplementation adjustment ( iron , vitamin D and calcium ) during the study period , significantly more often in the BP-limb group compared to the A-limb group ( p < 0.001 ) .


Patients in the BP-limb group had more frequent stools than patients in the A-limb group ; otherwise , gastro-intestinal symptoms rating scoring were comparable .


Complication rate was similar .


Gastric bypass with a 2-m BP-limb gives better weight loss than gastric bypass with a 60-cm BP-limb and a 150-cm A-limb .


Metabolic follow-up is of utmost importance , as most patients needed repeated adjustments of their supplementation .


The Diabetes Prevention Program ( DPP ) is highly effective in promoting weight loss in overweight and obese individuals .


However , one-on-one DPP sessions are costly .


As a cost-saving alternative , a group version of the DPP , called Group Lifestyle Balance program ( GLB ) , has been developed but has been shown to be less effective .


The aim of this two-arm parallel randomized controlled trial is to increase the effectiveness of the GLB by integrating habit formation techniques , namely if-then plans and their mental practice , into the program .


A total of 154 participants will be randomized to a standard or enriched GLB program .


For the enriched GLB program , if-then plans and their mental practice will be integrated into the standard GLB program .


Participants will be overweight or obese men and women ( BMI of 28 to 45kg/m2 , waist circumference88 for women , 102 for men , 18 to 75years of age ) who do less than 200minutes of self-reported moderate or vigorous exercise per week .


Measures will be completed at baseline , 3months , post-intervention ( 12months ) , and 12months post-intervention ( 24months ) .


The primary outcome measure is weight loss at 3 , 12 , and 24months .


Secondary outcomes include percent reaching weight loss goal , physical activity at 3 , 12 , and 24months , and weight-related risk factors ( waist circumference , hemoglobin A1c , systolic/diastolic blood pressure , total cholesterol/HDL ratio ) .


Standardized training of the life-style coaches , use of standardized manuals , and audio taping and reviewing of the sessions will ensure intervention fidelity .


The study will provide evidence-based data on the effectiveness of an enhanced GLB intervention in promoting weight loss and in reducing weight-related risk factors for chronic health problems .


Ethical clearance has been received from the Research Ethics and Compliance Board of the Faculty of Medicine Research and Graduate Studies Office at McGill University ( Montreal , Canada ) .


ClinicalTrials.gov Identifier : NCT02008435 .


Registered 6 December 2013 .


Endogenous pain modulation ( EPM ) is central to the processing of sensory information .


Visceral and somatic EPM are abnormal in irritable bowel syndrome , but have not been studied in functional dyspepsia ( FD ) .


Visceral EPM was assessed in 34 FD patients and 42 healthy controls .


Gastric pain was induced with oral capsaicin and EPM was studied by adding heterotopic thermal foot stimulation or distraction by STROOP test .


Somatic EPM was assessed using foot heat stimulation with heterotopic hand electrical stimulation .


Endogenous pain modulation by distraction reduced mean gastric pain by 11.9 on the 0-100 visual analog scale ( 95 % CI : 3.8-20 .1 ) in controls ( p = 0.006 ) and by 2.0 ( -6.18 to 10.44 ) in FD ( p = 0.6 ) , with greater EPM in controls than in FD ( difference -13.3 [ -26.1 to -0.5 ] ; p = 0.04 ) .


Endogenous pain modulation by heterotopic foot stimulation reduced gastric pain by 6.5 ( -0.7 to 13.6 ) in controls ( p = 0.07 ) and by 7.1 ( -2.29 to 16.47 ) in FD ( p = 0.1 ) , with no significant difference in EPM between controls and FD ( -2.0 [ -14.5 to 10.5 ] ; p = 0.75 ) .


In patients with prominent FD pain , greater pain correlated with decreased visceral EPM by distraction ( r = 0.51 , p = 0.04 ) .


Somatic EPM by heterotopic stimulation significantly decreased foot pain in controls ( p = 0.004 ) , but not in FD ( p = 0.80 ) .


In FD , visceral pain modulation by distraction was dysfunctional compared to controls .


Somatic pain modulation was also decreased in FD .


These data and the correlation of abnormal pain modulation by distraction with clinical pain in pain-predominant FD suggest a potential pathophysiological significance of abnormal pain modulation in FD .


To investigate the effect of an early childhood obesity prevention intervention , incorporating a parent modelling component , on fathers ' obesity risk-related behaviours .


Cluster randomized-controlled trial in the setting of pre-existing first-time parents groups organised by Maternal and Child Health Nurses in Victoria , Australia .


Participants were 460 first-time fathers mean age = 34.2 ( s.d. 4.90 ) years .


Dietary pattern scores of fathers were derived using principal component analysis , total physical activity and total television viewing time were assessed at baseline ( infant aged three to four months ) and after 15 months .


No significant beneficial intervention effect was observed on fathers ' dietary pattern scores , total physical activity or total television viewing time .


Despite a strong focus on parent modelling ( targeting parents own diet , physical activity and television viewing behaviours ) , and beneficial impact on mothers ' obesity risk behaviours , this intervention , with mothers as the point of contact , had no effect on fathers ' obesity risk-related behaviours .


Based on the established links between children 's obesity risk-related behaviors and that of their fathers , a need exists for research testing the effectiveness of interventions with a stronger engagement of fathers .


The time course of the contingent negative variation ( CNV ) as well as beta-power are known to entrain to regular task rhythms , revealing implicit anticipatory timing .


Thus far , these effects have been established for manual responses only .


Here we investigate entrainment preceding leg movements .


High-density EEG was recorded while participants were standing and responded to series of rhythmically presented arrow stimuli by making brisk leg movements .


The standard interval between reaction stimuli differed between series and was either 1500 or 2000 ms. Each series ' final interval was 1750 ms , representing a timing perturbation .


Entrainment was manifested in the CNV time course , where the maximum amplitude was reached just before the next stimulus was presented .


The pattern of beta - ( de ) synchronization similarly entrained to the task rhythm .


CNV scalp topographies suggested effector dependency of the entrainment-induced CNV .


We demonstrate that lower limb motor control , like upper limb control , readily entrains to a regular task rhythm .


These findings are relevant to Parkinson 's disease ( PD ) , where problems are found in rhythm processing and temporal preparation .


Investigation of the neural correlates of leg movement entrainment is important in view of presumed relations between entrainment and cueing of gait in PD .


Mixed cryoglobulinaemia is strongly related to hepatitis C virus infection .


Treatment with peg-interferon and ribavirin has been indicated as first-line therapy for mild/moderate hepatitis C virus-related mixed cryoglobulinaemia .


To evaluate the safety and efficacy of triple boceprevir-based antiviral therapy in patients with or without mixed cryoglobulinaemia previously treated with peg-interferon and ribavirin , and with advanced liver disease .


Thirty-five hepatitis C virus-positive patients ( 17 with asymptomatic mixed cryoglobulinaemia , 5 with symptomatic mixed cryoglobulinaemia , and 11 without mixed cryoglobulinaemia ) were treated with triple boceprevir-based antiviral therapy .


In 19/22 cryoglobulinaemic subjects ( 86 % ) , the addition of boceprevir induced cryocrit disappearance .


Cryocrit behaviour was related to virological response , with improvement of symptoms upon undetectable viraemia and reappearance after virological breakthrough .


The rate of sustained virological response was lower in cryoglobulinaemic patients than in patients without mixed cryoglobulinaemia ( 23.8 % vs 70 % respectively , p = 0.01 ) .


Boceprevir-based therapy was safe and effective in cryoglobulinaemic patients .


The correlation between direct inhibition of hepatitis C virus replication and clinical improvement in mixed cryoglobulinaemic patients is definitive proof of the key pathogenetic role played by viral replication .


Further studies are needed to confirm and clarify the reduced virological response in patients with mixed cryoglobulinaemia .


Bivalirudin has emerged as a meaningful alternative to heparin in patients undergoing percutaneous coronary intervention ( PCI ) .


To date , it is unclear whether bivalirudin has advantages in patients undergoing rotational atherectomy ( RA ) .


The current subgroup analysis of the ROTAXUS trial compared patients receiving bivalirudin ( n = 129 ) to those receiving unfractionated heparin ( UFH ) ( n = 111 ) .


Efficacy was assessed by the frequency of periprocedural myocardial infarction ( MI ) and safety by the frequency of major access-site bleeding ( ASB ) .


Baseline characteristics were similar .


Periprocedural MI occurred less frequently in the bivalirudin group ( 22 % vs. 37.5 % , p = 0.02 ) , while ASB did not differ significantly ( 2.3 % vs. 5.5 % , p = 0.20 ) .


This effect was larger in the RA group , where bivalirudin significantly reduced periprocedural MI ( 15.7 % vs. 38.7 % , p = 0.01 ) with a trend towards reduced major ASB ( 2.9 % vs. 10.2 % , p = 0.09 ) .


In the control group without RA , bivalirudin was not superior to UFH regarding periprocedural MI ( 28.6 % vs. 36.6 % , p = 0.42 ) and major ASB ( 1.7 % vs. 1.7 % , p = 0.99 ) .


This analysis suggests a differential benefit of bivalirudin in patients treated with RA .


Patients receiving bivalirudin during RA showed significantly less periprocedural MI and fewer ASB compared to patients treated with UFH .


Little is known on the long-term effects of obesity intervention programs in preschool-aged children .


We compared the long-term effects of a multidisciplinary treatment program with a usual-care program in seventy-five 3 - to 5-year-old overweight or obese children who had participated in a randomized controlled clinical trial .


A follow-up study collecting data at 18 and 36 months after starting both programs .


The multidisciplinary program consisted of diet counseling , exercise sessions teaching motor skills and focusing on an active lifestyle , and psychoeducation for parents .


Outcome measures were changes in anthropometry and body composition , determined by bioelectrical impedance analysis and ultrasound .


At the end of the 16-week treatment program , the multidisciplinary intervention showed a greater decrease in body mass index z score ( BMI-z ) ( mean ( SD ) 0.2 ( 0.1 ) ) and waist circumference z score ( WC-z ) ( mean ( SD ) 0.3 ( 0.1 ) ) , than usual-care .


During the 36-month follow-up , a significant overall treatment effect of the multidisciplinary intervention program was demonstrated on BMI-z ( 0.28 , 95 % CI 0.03-0 .54 ) and abdominal subcutaneous fat ( SCF ) ( 0.23 , 95 % CI 0.01-0 .45 ) , compared with the usual-care program .


A multidisciplinary intervention program in 3 - to 5-year-old overweight and obese children shows greater long-term effects on reductions in BMI-z and SCF , compared with a usual-care program .


Severe neonatal jaundice and its progression to kernicterus is a leading cause of death and disability among newborns in poorly-resourced countries , particularly in sub-Saharan Africa .


The standard treatment for jaundice using conventional phototherapy ( CPT ) with electric artificial blue light sources is often hampered by the lack of ( functional ) CPT devices due either to financial constraints or erratic electrical power .


In an attempt to make phototherapy ( PT ) more readily available for the treatment of pathologic jaundice in underserved tropical regions , we set out to test the hypothesis that filtered sunlight phototherapy ( FS-PT ) , in which potentially harmful ultraviolet and infrared rays are appropriately screened , will be as efficacious as CPT .


This prospective , non-blinded randomized controlled non-inferiority trial seeks to enroll infants with elevated total serum/plasma bilirubin ( TSB , defined as 3 mg/dl below the level recommended by the American Academy of Pediatrics for high-risk infants requiring PT ) who will be randomly and equally assigned to receive FS-PT or CPT for a total of 616 days at an inner-city maternity hospital in Lagos , Nigeria .


Two FS-PT canopies with pre-tested films will be used .


One canopy with a film that transmits roughly 33 % blue light ( wavelength range : 400 to 520 nm ) will be used during sunny periods of a day .


Another canopy with a film that transmits about 79 % blue light will be used during overcast periods of the day .


The infants will be moved from one canopy to the other as needed during the day with the goal of keeping the blue light irradiance level above 8 W/cm/nm .


FS-PT will be as efficacious as CPT in reducing the rate of rise in bilirubin levels .


Secondary outcome : The number of infants requiring exchange transfusion under FS-PT will not be more than those under CPT .


This novel study offers the prospect of an effective treatment for infants at risk of severe neonatal jaundice and avoidable exchange transfusion in poorly-resourced settings without access to ( reliable ) CPT in the tropics .


ClinicalTrials.gov Identifier : NCT01434810 .


Preclinical studies suggest that lithium carbonate ( lithium ) can reduce precipitated cannabinoid withdrawal in rats by stimulating release of the neuropeptide oxytocin , while two open-label studies indicate lithium may ameliorate cannabis withdrawal symptoms in humans .


This study was conducted to examine the efficacy and safety of lithium in the inpatient management of cannabis withdrawal and to determine whether lithium affects plasma oxytocin and the rate of elimination of plasma cannabinoids during abstinence .


Treatment-seeking cannabis-dependent adults ( n = 38 ) were admitted for 8days to an inpatient withdrawal unit and randomized to either oral lithium ( 500mg ) or placebo given twice a day under double-blind randomized controlled trial ( RCT ) conditions .


Primary outcomes included withdrawal severity [ cannabis withdrawal scale ( CWS ) ] , rates of detoxification completion , and adverse events .


Plasma cannabinoids , plasma oxytocin and serum lithium levels were measured repeatedly over admission .


Follow-up research interviews were conducted at 14 , 30 , and 90days postdischarge .


Lithium did not significantly affect total CWS scores relative to placebo , although it significantly reduced individual symptoms of `` loss of appetite , '' `` stomach aches , '' and `` nightmares/strange dreams . ''


No significant group differences were found in treatment retention or adverse events .


Lithium did not increase plasma oxytocin levels nor influence the rate of elimination of cannabinoids .


Both placebo - and lithium-treated participants showed reduced levels of cannabis use ( verified by urinalysis ) and improved health and psychosocial outcomes at 30 - and 90-day follow-up relative to pretreatment baselines .


Despite the strong rationale for the present study , the efficacy of lithium over placebo in the management of cannabis withdrawal was not demonstrated .


While vitamin D supplementation and exercise are recommended for prevention of falls for older people , results regarding these 2 factors are contradictory .


To determine the effectiveness of targeted exercise training and vitamin D supplementation in reducing falls and injurious falls among older women .


A 2-year randomized , double-blind , placebo-controlled vitamin D and open exercise trial conducted between April 2010 and March 2013 in Tampere , Finland .


Participants were 409 home-dwelling women 70 to 80 years old .


The main inclusion criteria were at least 1 fall during the previous year , no use of vitamin D supplements , and no contraindication to exercise .


Four study groups , including placebo without exercise , vitamin D ( 800 IU/d ) without exercise , placebo and exercise , and vitamin D ( 800 IU/d ) and exercise .


The primary outcome was monthly reported falls .


Injurious falls and the number of fallers and injured fallers were reported as secondary outcomes .


In addition , bone density , physical functioning ( muscle strength , balance , and mobility ) , and vitamin D metabolism were assessed .


Intent-to-treat analyses showed that neither vitamin D nor exercise reduced falls .


Fall rates per 100 person-years were 118.2 , 132.1 , 120.7 , and 113.1 in the placebo without exercise , vitamin D without exercise , placebo and exercise , and vitamin D and exercise study groups , respectively ; however , injurious fall rates were 13.2 , 12.9 , 6.5 , and 5.0 , respectively .


Hazard ratios for injured fallers were significantly lower among exercisers with vitamin D ( 0.38 ; 95 % CI , 0.17-0 .83 ) and without vitamin D ( 0.47 ; 95 % CI , 0.23-0 .99 ) .


Vitamin D maintained femoral neck bone mineral density and increased tibial trabecular density slightly .


However , only exercise improved muscle strength and balance .


Vitamin D did not enhance exercise effects on physical functioning .


The rate of injurious falls and injured fallers more than halved with strength and balance training in home-dwelling older women , while neither exercise nor vitamin D affected the rate of falls .


Exercise improved physical functioning .


Future research is needed to determine the role of vitamin D in the enhancement of strength , balance , and mobility .


clinicaltrials.gov Identifier : NCT00986466 .


On-treatment platelet reactivity ( OTR ) is a predictor of clinical outcomes in patients receiving thienopyridine therapy .


To assess whether point-of-care platelet reactivity testing can discriminate between patients who have and have not received a thienopyridine .


This was an analysis of a randomized , multicenter , pharmacodynamic trial .


Subjects with coronary artery disease treated with aspirin were randomly assigned to clopidogrel 75mg daily or prasugrel 10mg daily for 7days .


Platelet reactivity assessment with the VerifyNow P2Y12 test was performed before study drug admistration and 24h after the final dose .


Optimal cut-offs for a detectable drug effect were identified by the use of receiver operating characteristic curve analysis .


A total of 54 subjects were enrolled and completed the study .


The c-statistic for the identification of a thienopyridine effect was highly significant ( 0.93 , P < 0.001 ) , including for the clopidogrel and prasugrel groups considered separately ( P < 0.001 for both ) .


The optimal cut-off was < 213 P2Y12 reaction units ( PRU ) , which provided a sensitivity of 80 % and a specificity of 98 % .


This cut-off provided a sensitivity of 58 % and a specificity of 100 % for a clopidogrel effect , and a sensitivity of 100 % and specificity of 96 % for a prasugrel effect .


OTR of < 213PRU is highly specific for exposure to either clopidogrel or prasugrel .


This may be useful in the management of thienoypridine-treated patients who require surgery .


Furthermore , this diagnostic cut-off is similar to levels of OTR that have been associated with ischemic events in thienopyridine-treated patients , supporting the contention that a lack of drug effect is the mechanistic basis for the prognostic relationship between OTR and clinical outcomes .


Rikkunshito , a standardized Japanese herbal medicine , is thought to accelerate gastric emptying and relieve dyspepsia , although no large-scale , randomized , placebo-controlled trials of rikkunshito have been conducted .


This study aimed to determine the efficacy and safety of rikkunshito for treating functional dyspepsia ( FD ) .


FD patients received 2.5 g rikkunshito or placebo three times a day for 8 weeks in this multicenter , randomized , placebo-controlled , parallel-group trial .


The primary end point was the proportion of responders at 8 weeks after starting test drug , determined by global patient assessment ( GPA ) .


The improvement in four major dyspepsia symptoms severity scale was also evaluated .


In addition , plasma ghrelin levels were investigated before and after treatment .


Two hundred forty-seven patients were randomly assigned .


In the eighth week , the rikkunshito group had more GPA responders ( 33.6 % ) than the placebo ( 23.8 % ) , although this did not reach statistical significance ( p = 0.09 ) .


Epigastric pain was significantly improved ( p = 0.04 ) and postprandial fullness tended to improve ( p = 0.06 ) in the rikkunshito group at week 8 .


Rikkunshito was relatively more effective among Helicobacter pylori-infected participants ( rikkunshito : 40.0 % vs placebo : 20.5 % , p = 0.07 ) , and seemed less effective among H. pylori-uninfected participants ( rikkunshito : 29.3 % vs placebo : 25.6 % , p = 0.72 ) .


Among H. pylori-positive individuals , acyl ghrelin levels were improved just in rikkunshito group .


There were no severe adverse events in both groups .


Administration of rikkunshito for 8 weeks reduced dyspepsia , particularly symptoms of epigastric pain and postprandial fullness .


( UMIN Clinical Trials Registry , Number UMIN000003954 ) .


There is debate about benefits of acupuncture for knee pain .


To determine the efficacy of laser and needle acupuncture for chronic knee pain .


Zelen-design clinical trial ( randomization occurred before informed consent ) , in Victoria , Australia ( February 2010-December 2012 ) .


Community volunteers ( 282 patients aged 50 years with chronic knee pain ) were treated by family physician acupuncturists .


No acupuncture ( control group , n = 71 ) and needle ( n = 70 ) , laser ( n = 71 ) , and sham laser ( n = 70 ) acupuncture .


Treatments were delivered for 12 weeks .


Participants and acupuncturists were blinded to laser and sham laser acupuncture .


Control participants were unaware of the trial .


Primary outcomes were average knee pain ( numeric rating scale , 0 [ no pain ] to 10 [ worst pain possible ] ; minimal clinically important difference [ MCID ] , 1.8 units ) and physical function ( Western Ontario and McMaster Universities Osteoarthritis Index , 0 [ no difficulty ] to 68 [ extreme difficulty ] ; MCID , 6 units ) at 12 weeks .


Secondary outcomes included other pain and function measures , quality of life , global change , and 1-year follow-up .


Analyses were by intention-to-treat using multiple imputation for missing outcome data .


At 12 weeks and 1 year , 26 ( 9 % ) and 50 ( 18 % ) participants were lost to follow-up , respectively .


Analyses showed neither needle nor laser acupuncture significantly improved pain ( mean difference ; -0.4 units ; 95 % CI , -1.2 to 0.4 , and -0.1 ; 95 % CI , -0.9 to 0.7 , respectively ) or function ( -1.7 ; 95 % CI , -6.1 to 2.6 , and 0.5 ; 95 % CI , -3.4 to 4.4 , respectively ) compared with sham at 12 weeks .


Compared with control , needle and laser acupuncture resulted in modest improvements in pain ( -1.1 ; 95 % CI , -1.8 to -0.4 , and -0.8 ; 95 % CI , -1.5 to -0.1 , respectively ) at 12 weeks , but not at 1 year .


Needle acupuncture resulted in modest improvement in function compared with control at 12 weeks ( -3.9 ; 95 % CI , -7.7 to -0.2 ) but was not significantly different from sham ( -1.7 ; 95 % CI , -6.1 to 2.6 ) and was not maintained at 1 year .


There were no differences for most secondary outcomes and no serious adverse events .


In patients older than 50 years with moderate or severe chronic knee pain , neither laser nor needle acupuncture conferred benefit over sham for pain or function .


Our findings do not support acupuncture for these patients .


anzctr.org.au Identifier : ACTRN12609001001280 .


To compare the reciprocal control of agonist and antagonist muscles in individuals with and without spinocerebellar ataxia ( SCA ) and to evaluate the effect of a 4-week leg cycling regimen on functional coordination and reciprocal control of agonist and antagonist muscles in patients with SCA .


Randomized controlled trial with repeated measures .


Research laboratory in a general hospital .


Individuals with SCA ( n = 20 ) and without SCA ( n = 20 ) .


A single 15-minute session of leg cycling and a 4-week cycling regimen .


Individuals with SCA ( n = 20 ) and without SCA ( n = 20 ) underwent disynaptic reciprocal inhibition and D1 inhibition tests of the soleus muscles before and after a single 15-minute cycling session .


Individuals with SCA were randomly assigned to either participate in 4 weeks of cycling training ( n = 10 ) or to receive no training ( n = 10 ) .


The disynaptic reciprocal inhibition and D1 inhibition and International Cooperative Ataxia Rating Scale ( ICARS ) scores were evaluated in both groups after 4 weeks .


Individuals with SCA showed abnormally strong resting values of disynaptic reciprocal inhibition and D1 inhibition ( P < .001 ) and impaired inhibition modulation capacity after a single 15-minute session of cycling ( P < .001 ) .


The inhibition modulation capacity was restored ( P < .001 ) , and the ICARS scores improved significantly ( pre : 13.59.81 , post : 11.38.74 ; P = .046 ) after 4 weeks of cycling training .


A 4-week cycling regimen can normalize the modulation of reciprocal inhibition and functional performance in individuals with SCA .


These findings are applicable to the coordination training of patients .


In 2011 , supported by data from two separate trauma centers , we implemented a protocol to administer tranexamic acid ( TXA ) in trauma patients with evidence of hyperfibrinolysis ( HF ) on admission .


The purpose of this study was to examine whether the use of TXA in patients with HF determined by admission rapid thrombelastography was associated with improved survival .


Following institutional review board approval , we evaluated all trauma patients 16 years or older admitted between September 2009 and September 2013 .


HF was defined as LY-30 of 3 % or greater .


Patients with LY-30 less than 3.0 % were excluded .


Patients were divided into those who received TXA ( TXA group ) and those who did not ( no-TXA group ) .


After univariate analyses , a purposeful , logistic regression model was developed a priori to evaluate the impact of TXA on mortality ( controlling for age , sex , Injury Severity Score ( ISS ) , arrival physiology , and base deficit ) .


A total of 1,032 patients met study criteria .


Ninety-eight ( 10 % ) received TXA , and 934 ( 90 % ) did not .


TXA patients were older ( median age , 37 years vs. 32 years ) , were more severely injured ( median ISS , 29 vs. 14 ) , had a lower blood pressure ( median systolic blood pressure 103 mm Hg vs. 125 mm Hg ) , and were more likely to be in shock ( median , base excess , -5 mmol/dL vs. -2 mmol/dL ) , all p < 0.05 .


Twenty-three percent of the patients had a repeat thrombelastography within 6 hours ; 8.8 % of the TXA patients had LY-30 of 3 % or greater on repeat rapid thrombelastography ( vs. 10.1 % in the no-TXA group , p = 0.679 ) .


Unadjusted in-hospital mortality was higher in the TXA group ( 40 % vs. 17 % , p < 0.001 ) .


There were no differences in venous thromboembolism ( 3.3 % vs. 3.8 % ) .


Logistic regression failed to find a difference in in-hospital mortality among those receiving TXA ( odds ratio , 0.74 ; 95 % confidence interval , 0.38-1 .40 ; p 0.80 ) .


In the current study , the use of TXA was not associated with a reduction in mortality .


Further studies are needed to better define who will benefit from an administration of TXA .


Therapeutic study , level IV .


Successful external cephalic version ( ECV ) for breech presenting fetus reduces the need for Caesarean section ( CS ) .


We aimed to compare the success rate of ECV with either spinal anaesthesia ( SA ) or i.v. analgesia using remifentanil .


In a double-phased , stratified randomized blinded controlled study we compared the success rates of ECV , performed under spinal anaesthesia ( SA ) , i.v. analgesia ( IVA ) using remifentanil or no anaesthetic interventions .


In phase I , 189 patients were stratified by parity before randomization to ECV , performed by blinded operators , under SA using either hyperbaric bupivacaine 9 mg with fentanyl 15 g , i.v. remifentanil infusion 0.1 g kg min ( -1 ) , or Control ( no anaesthetic intervention ) .


Operators performing ECV were blinded to the treatment allocation .


In phase 2 , patients in the Control group in whom the initial ECV failed were further randomized to receive either SA ( n = 9 ) or IVA ( n = 9 ) for a re-attempt .


The primary outcome was the incidence of successful ECV .


The success rate in Phase 1 was greatest using SA [ 52/63 ( 83 % ) ] , compared with IVA [ 40/63 ( 64 % ) ] and Control [ 40/63 ( 64 % ) ] , ( P = 0.027 ) .


Median [ IQR ] pain scores on a visual analogue scale ( range 0-100 ) , were 0 [ 0-0 ] with SA , 35 [ 0-60 ] with IVA and 50 [ 30-75 ] in the Control group ( P < 0.001 ) .


Median [ IQR ] VAS sedation scores were highest with IVA [ 75 ( 50-80 ) ] , followed by SA , [ 0 ( 0-50 ) ] and Control [ 0 ( 0-0 ) ] .


In phase 2 , 7/9 ( 78 % ) of ECV re-attempts were successful with SA , whereas all re-attempts using IVA failed ( P = 0.0007 ) .


The incidence of fetal bradycardia necessitating emergency CS within 30 min , was similar among groups ; 1.6 % ( 1/63 ) in the SA and IVA groups and 3.2 % ( 2/63 ) in the Control group .


SA increased the success rate and reduced pain for both primary and re-attempts of ECV , whereas IVA using remifentanil infusion only reduced the pain .


There was no significant increase in the incidence of fetal bradycardia or emergency CS , with ECV performed under anaesthetic interventions .


Relaxation of the abdominal muscles from SA appears to underlie the improved outcomes for ECV .


As the population ages , it is increasingly important to test new models of care that improve life quality and decrease health costs .


This paper presents the rationale and design for a randomized clinical trial of a novel interdisciplinary program to reduce disability among low income older adults based on a previous pilot trial of the same design showing strong effect .


The CAPABLE ( Community Aging in Place , Advancing Better Living for Elders ) trial is a randomized controlled trial in which low income older adults with self-care disability are assigned to one of two groups : an interdisciplinary team of a nurse , occupational therapist , and handyman to address both personal and environmental risk factors for disability based on participants ' functional goals , or an attention control of sedentary activities of choice .


Both groups receive up to 10 home visits over 4 months .


The primary outcome is decreased disability in self-care ( ADL ) .


Secondary outcomes are sustained decrease in self care disability as well as improvement in instrumental ADLS , strength , balance , walking speed , and health care utilization .


Careful cost tracking and analysis using intervention data and claims data will enable direct measurement of the cost impact of the CAPABLE approach .


CAPABLE has the potential to leverage current health care spending in Medicaid waivers , Accountable Care Organizations and other capitated systems to save the health care system costs as well as improving low income older adults ' ability to age at home with improved life quality .


Our aim was to compare changes of vascular and metabolic parameters in patients with essential hypertension on treatment with combination of perindopril with either indapamide retard or hydrochlorothiazide .


The study involved 40 patients who were randomly assigned to perindopril 5-10 mg/day in combination with indapamide retard ( P+I ) 1.5 mg/day ( n = 20 ) or with hydrochlorothiazide ( P+HT ) 25 mg/day ( n = 20 ) .


Waist circumference , body mass index , blood lipids and glucose , endothelial function ( EF ) determined as the change of resistance index after inhalation of salbutamol , arterial stiffness measured as mean pulse wave velocity after sublingual trinitroglycerin ( PWVtng ) were evaluated at baseline and 6 months thereafter .


Vascular responses were calculated from digital pulse waves registered using photoplethysmography .


Dynamics of BP after 6 months did not differ significantly between groups .


Treatment with combination of P+HT resulted in significant decrease of EF ( -24,3 % , p < 0,05 ) accompanied by negative changes of triglycerides ( +13,4 % , p < 0,05 ) and glucose levels ( +9,8 % , p < 0,05 ) , whereas combination of P+I did not affect endothelial function and was metabolically neutral .


PWVtng significantly decreases on both regiments of treatment with the trend in favor of P+I combination ( -13,4 % , p < 0,001 versus -9,8 % , p < 0,01 for P+I and P+HT combinations , respectively ) .


Thus , despite the similar BP reduction the combination of ACE-inhibitor -- perindopril with indapamide retard possesses more favorable vascular and metabolic effects compared to combination with hydrochlorothiazide that potentially may account for different prognosis of patients with arterial hypertension on long-term treatment .


There is non-experimental evidence that paracetamol ( acetaminophen ) use may increase the risk of developing asthma .


However , numerous methodological issues need to be resolved before undertaking a randomized controlled trial to investigate this hypothesis .


To establish the feasibility of a randomized controlled trial of liberal paracetamol as usually given by parents/guardians vs. a comparator ( restricted paracetamol in accordance with WHO guidelines , ibuprofen or placebo ) , and childhood asthma risk .


Questionnaires were completed by parents/guardians of infants admitted to Wellington Hospital with bronchiolitis to assess views about comparator treatments .


Subsequently , infants of parents/guardians who provided informed consent were randomized to restricted or liberal paracetamol use for 3 months with paracetamol use recorded .


Of 120 eligible participants , 72 ( 60 % ) parents/guardians completed the questionnaire .


Ibuprofen , restricted paracetamol and placebo were acceptable to 42 ( 58 % ) , 29 ( 40 % ) and 9 ( 12 % ) parents/guardians , respectively .


36 ( 30 % ) infants were randomized to restricted or liberal paracetamol .


Paracetamol use was greater for the liberal vs. restricted group for reported [ Hodges-Lehmann estimator of difference 0.94 mg/kg/day ( 95 % CI 0.2-3 .52 ) , P = 0.02 ] and measured use [ Hodges-Lehmann estimator of difference 2.11 mg/kg/day ( 95 % CI 0.9-4 .18 ) , P = 0.004 ] .


The median reported and measured use of paracetamol was 2.0-fold and 3.5-fold greater in the liberal vs. restricted group .


Although separation in paracetamol dosing is likely to be achieved with a liberal vs. restricted paracetamol regime , ibuprofen is the preferred comparator treatment in the proposed RCT of paracetamol use and risk of asthma in childhood .


In cancer research , outcome measures may co-vary .