Central obesity in polycystic ovary syndrome ( PCOS ) is associated with increased inflammatory markers and increased risk for type 2 diabetes .


The objective of the study was to evaluate whether treatment with metformin ( M ) or M combined with oral contraceptive pills ( OCPs ) resulted in a more advantageous body composition than treatment with OCP alone .


The study was conducted at an outpatient clinic .


This was a randomized , controlled clinical trial .


Ninety patients with PCOS were randomized to 12 months ' treatment with M ( 2 g/d ) , M + OCP ( 150 mg desogestrel +30 g ethinylestradiol ) , or OCP .


Whole-body dual-energy x-ray absorptiometry scans and clinical and hormonal evaluations were performed before and after the intervention period .


A total of 65 of 90 patients completed the study .


Changes in weight at 6 and 12 months and changes in regional fat mass estimates at 12 months were measured .


Dropout rates between intervention groups were not significantly different .


Treatment with M and M+OCP were superior to OCP regarding weight and regional fat mass .


The median ( quartiles ) weight changes during 12 months of M , M+OCP , and OCP treatment were -3.0 ( -10.3 ; 0.6 ) , -1.9 ( -4.9 ; 0.1 ) , and 1.2 ( -0.8 ; 3.0 ) kg , respectively , P < .05 .


Upper to lower fat mass ratio was unchanged .


Changes in body composition were predicted by the type of medical intervention ( M , M+OCP , or OCP ) and not by body mass index at study inclusion .


OCP and M+OCP were superior to M regarding reduction in free T levels .


M treatment alone or in combination with OCP was associated with weight loss and improved body composition compared with OCP , whereas free T levels decreased during M+OCP or OCP .


Combined treatment with M+OCP should be considered as an alternative to treatment with OCP alone to avoid weight gain in PCOS .


To compare visual acuity , intraocular lens ( IOL ) movement , and depth of focus with the Crystalens HD single-optic accommodating IOL and the Tecnis ZCB00 aspheric monofocal IOL .


St. Thomas ' Hospital , London , United Kingdom .


Prospective randomized controlled trial .


Patients with bilateral symptomatic cataract had bilateral sequential cataract surgery within 6 weeks with randomized implantation of the accommodating or monofocal IOL in both eyes .


Exclusion criteria included other ocular conditions and corneal astigmatism greater than 2.00 diopters .


The primary outcome was uniocular distance-corrected near visual acuity ( DCNVA ) .


Secondary measures were IOL movement , depth of focus , intermediate and distance vision , objective refraction , and pupil size at distance and near fixation .


Results from 3 months postoperatively are presented .


Three months postoperatively , 64 patients ( 32 in each group ) were available for study .


The distance vision was not statistically significantly different between the accommodating IOL and monofocal IOL ( mean 0.05 logMAR versus 0.06 logMAR ) .


The mean DCNVA ( 0.48 logMAR 0.15 [ SD ] versus 0.61 0.13 logMAR ) and intermediate visual acuity ( 0.08 0.1 logMAR versus 0.20 0.09 logMAR ) were significantly better with the accommodating IOL ( P < .001 ) .


Neither IOL had clinically significant movement , and near vision did not directly correlate with movement of the accommodating IOL .


The accommodating IOL provided greater depth of focus .


Near and intermediate acuities were better with the accommodating IOL .


This effect was not directly linked to IOL movement but was at least partly due to depth of focus .


Whether addition of fluorouracil to epirubicin , cyclophosphamide , and paclitaxel ( EC-P ) is favourable in adjuvant treatment of patients with node-positive breast cancer is controversial , as is the benefit of increased density of dosing .


We aimed to address these questions in terms of improvements in disease-free survival .


In this 22 factorial , open-label , phase 3 trial , we enrolled patients aged 18-70 years with operable , node positive , early-stage breast cancer from 81 Italian centres .


Eligible patients were randomly allocated in a 1:1:1:1 ratio with a centralised , interactive online system to receive either dose-dense chemotherapy ( administered intravenously every 2 weeks with pegfilgrastim support ) with fluorouracil plus EC-P ( FEC-P ) or EC-P or to receive standard-interval chemotherapy ( administered intravenously every 3 weeks ) with FEC-P or EC-P .


The primary study endpoint was disease-free survival , assessed with the Kaplan-Meier method in the intention-to-treat population .


Our primary comparisons were between dose schedule ( every 2 weeks vs every 3 weeks ) and dose type ( FEC-P vs EC-P ) .


This study is registered with ClinicalTrials.gov , number NCT00433420 .


Between April 24 , 2003 , and July 3 , 2006 , we recruited 2091 patients .


88 patients were enrolled in centres that only provided standard-intensity dosing .


After a median follow-up of 70 years ( interquartile range [ IQR ] 45-63 ) , 140 ( 26 % ) of 545 patients given EC-P every 3 weeks , 157 ( 29 % ) of 544 patients given FEC-P every 3 weeks , 111 ( 22 % ) of 502 patients given EC-P every 2 weeks , and 113 ( 23 % ) of 500 patients given FEC-P every 2 weeks had a disease-free survival event .


For the dose-density comparison , disease-free survival at 5 years was 81 % ( 95 % CI 79-84 ) in patients treated every 2 weeks and 76 % ( 74-79 ) in patients treated every 3 weeks ( HR 077 , 95 % CI 065-092 ; p = 0004 ) ; overall survival rates at 5 years were 94 % ( 93-96 ) and 89 % ( 87-91 ; HR 065 , 051-084 ; p = 0001 ) and for the chemotherapy-type comparison , disease-free survival at 5 years was 78 % ( 75-81 ) in the FEC-P groups and 79 % ( 76-82 ) in the EC-P groups ( HR 106 , 089-125 ; p = 0561 ) ; overall survival rates at 5 years were 91 % ( 89-93 ) and 92 % ( 90-94 ; 116 , 091-146 ; p = 0234 ) .


Compared with 3 week dosing , chemotherapy every 2 weeks was associated with increased rate of grade 3-4 of anaemia ( 14 [ 14 % ] of 988 patients vs two [ 02 % ] of 984 patients ; p = 0002 ) ; transaminitis ( 19 [ 19 % ] vs four [ 04 % ] ; p = 0001 ) , and myalgias ( 31 [ 31 % ] vs 16 [ 16 % ] ; p = 0019 ) , and decreased rates of grade 3-4 neutropenia ( 147 [ 149 % ] vs 433 [ 440 % ] ; p < 00001 ) .


Addition of fluorouracil led to increased rates of grade 3-4 neutropenia ( 354 [ 345 % ] of 1025 patients on FEC-P vs 250 [ 242 % ] of 1032 patients on EC-P ; p < 00001 ) , fever ( nine [ 09 % ] vs two [ 02 % ] ) , nausea ( 47 [ 46 % ] vs 28 [ 27 % ] ) , and vomiting ( 32 [ 31 % ] vs 15 [ 14 % ] ) .


In patients with node-positive early breast cancer , dose-dense adjuvant chemotherapy improved disease-free survival compared with standard interval chemotherapy .


Addition of fluorouracil to a sequential EC-P regimen was not associated with an improved disease-free survival outcome .


Bristol-Myers Squibb , Pharmacia , and Domp Biotec .


We present and validate a multivariate model that partially compensates for retinal nerve fiber layer ( RNFL ) intersubject variability .


A total of 202 healthy volunteers randomly attributed to a training ( TS ) and a validation ( VS ) sample underwent complete ophthalmic examination , including Fourier-domain optical coherence tomography ( FD-OCT ) .


We acquired FD-OCT data centered at the optic disc ( OD ) and the macula .


Two-dimensional ( 2D ) projection images were computed and registered , to determine the distance between fovea and OD centers ( FD ) and their respective angle ( FA ) .


Retinal vessels were automatically segmented in the projection images and used to calculate the circumpapillary retinal vessel density ( RVD ) profile .


Using the TS , a multivariate model was calculated for each of 256 sectors of the RNFL , including OD ratio , orientation and area , RVD , FD , FA , age , and refractive error .


Model selection was based on Akaike Information Criteria .


The compensation effect was determined for 12 clock hour sectors , comparing the coefficients of variation ( CoV ) of measured and model-compensated RNFL thicknesses .


The model then was applied to the VS , and CoV was calculated .


The R value for the multivariate model was , on average 0.57 ( max = 0.68 ) .


Compensation reduced the CoV on average by 18 % , both for the TS and VS ( up to 23 % and 29 % ) , respectively .


We have developed and validated a comprehensive multivariate model that may be used to create a narrower range of normative RNFL data , which could improve diagnostic separation between early glaucoma and healthy subjects .


This , however , remains to be demonstrated in future studies .


ACTION , a 24-week , prospective , randomized , parallel-group , double-blind study in patients with severe Alzheimer 's disease ( AD ) , demonstrated significant efficacy of 13.3 mg/24 h versus 4.6 mg/24 h rivastigmine patch on the Severe Impairment Battery ( SIB ) and Alzheimer 's Disease Cooperative Study-Activities of Daily Living scale-Severe Impairment Version ( ADCS-ADL-SIV ) .


Overall , 61 % of the study population received at least 1 dose of concomitant memantine , regardless of dose or duration .


This retrospective analysis investigated the effects of concomitant memantine on the efficacy , safety and tolerability of 13.3 mg/24 h versus 4.6 mg/24 h rivastigmine patch .


Patients were stratified according to whether or not they received at least one dose of concomitant memantine during the double-blind phase .


Changes from baseline on the SIB and ADCS-ADL-SIV were compared using analysis of covariance ( ANCOVA ) with treatment , pooled center , memantine usage and treatment-by-memantine as factors , and baseline as a covariate .


Safety and tolerability were assessed .


Memantine-treated patients were younger than those not receiving memantine ( mean 75.9 and 78.8 years , respectively ) , with a lower screening Mini-Mental State Examination ( 8.6 and 9.2 , respectively ) .


ANCOVA confirmed there was no significant interaction ( p > 0.1 ) between study treatment and memantine use on the SIB or ADCS-ADL-SIV .


The incidence of adverse events was : 71.4 % , 13.3 mg/24 h patch with memantine ; 79.7 % , 13.3 mg/24 h patch alone ; 74.7 % , 4.6 mg/24 h patch with memantine ; and 71.1 % , 4.6 mg/24 h patch alone .


These data suggest benefit of 13.3 mg/24 h versus 4.6 mg/24 h rivastigmine patch , regardless of concomitant memantine use .


The incidence of adverse events with highdose patch was similar in memantine-treated patients and those not receiving memantine .


Childhood asthma morbidity remains significant , especially in low-income children .


Most often , asthma management is provided by the child 's primary care provider .


We sought to evaluate whether enhancing primary care management for persistent asthma with telephone-based peer coaching for parents reduced asthma impairment and risk in children 3 to 12 years old .


Over 12 months , peer trainers provided parents with asthma management training by telephone ( median , 18 calls ) and encouraged physician partnership .


The intervention was evaluated in a cluster-randomized trial of 11 intervention and 11 usual care pediatric practices ( 462 and 486 families , respectively ) .


Patient outcomes were assessed by means of telephone interviews at 12 and 24 months conducted by observers blinded to intervention assignment and compared by using mixed-effects models , controlling for baseline values and clustering within practices .


In a planned subgroup analysis we examined the heterogeneity of the intervention effect by insurance type ( Medicaid vs other ) .


After 12 months , intervention participation resulted in 20.9 ( 95 % CI , 9.1-32 .7 ) more symptom-free days per child than in the control group , and there was no difference in emergency department ( ED ) visits .


After 24 months , ED visits were reduced ( difference in mean visits/child , -0.28 ; 95 % CI , -0.5 to -0.02 ) , indicating a delayed intervention effect .


In the Medicaid subgroup , after 12 months , intervention participation resulted in 42 % fewer ED visits ( difference in mean visits/child , -0.50 ; 95 % CI , -0.81 to -0.18 ) and 62 % fewer hospitalizations ( difference in mean hospitalizations/child , -0.16 ; 95 % CI , -0.30 to -0.014 ) .


Reductions in health care use endured through 24 months .


This pragmatic telephone-based peer-training intervention reduced asthma impairment .


Asthma risk was reduced in children with Medicaid insurance .


The Study to Assess Long-term Opioid Medication Effectiveness ( SALOME ) is a two-stage phase III , single site ( Vancouver , Canada ) , randomized , double blind controlled trial designed to test if hydromorphone is as effective as diacetylmorphine for the treatment of long-term illicit opioid injection .


Recruiting participants for clinical trials continues to be a challenge in medical and addiction research , with many studies not being able to reach the planned sample size in a timely manner .


The aim of this study is to describe the recruitment strategies in SALOME , which offered appealing treatments but had limited clinic capacity and no guaranteed post-trial continuation of the treatments .


SALOME included chronic opioid-dependent , current illicit injection opioid users who had at least one previous episode of opioid maintenance treatment .


Regulatory approvals were received in June 2011 and recruitment strategies were implemented over the next 5 months .


Recruitment strategies included ongoing open communication with the community , a consistent and accessible team and participant-centered screening .


All applicants completed a pre-screening checklist to assess prerequisites .


Applicants meeting these prerequisites were later contacted to commence the screening process .


A total of 598 applications were received over the two-year recruitment period ; 130 were received on the first day of recruitment .


Of these applicants , 485 met prerequisites ; however , many could not be found or were not reached before recruitment ended .


For the 253 candidates who initiated the screening process , the average time lapse between application and screening date was 8.3 months ( standard deviation [ SD ] = 4.44 ) and for the 202 randomized to the study , the average processing time from initial screen to randomization was 25.9 days ( SD = 37.48 ; Median = 15.0 ) .


As in prior trials offering injectable diacetylmorphine within a supervised model , recruiting participants for this study took longer than planned .


The recruitment challenges overcome in SALOME were due to the high number of applicants compared with the limited number that could be randomized and treated .


Our study emphasizes the value of integrating these strategies into clinical addiction research to overcome study-specific barriers .


ClinicalTrials.gov : NCT01447212 .


To compare a single leukocyte-poor ( type-4B ) platelet-rich plasma ( PRP ) injection versus bupivacaine injection for recalcitrant lateral epicondylar tendinopathy ( LET ) .


25 patients aged 27 to 50 years with painful and recalcitrant LET of the humerus were randomised to receive leukocyte-poor ( type-4B ) PRP ( n = 15 ) or bupivacaine ( n = 10 ) injection .


Outcome measures included visual analogue scale ( VAS ) for pain , modified Mayo clinic performance index for elbow ( MMCPIE ) for elbow function , and Nirschl score for activity-related pain at 1 , 3 , 6 , and 12 months by a single assessor .


At baseline , the PRP and bupivacaine groups were comparable in terms of age , sex , duration of symptoms , VAS for pain , MMCPIE score , and Nirschl score .


After one month , the percentage of improvement was less in the PRP than bupivacaine group in terms of the VAS for pain ( 17.7 % vs. 26.5 % ) , MMCPIE score ( 24.0 % vs. 27.6 % ) , and Nirschl score ( 20.7 % vs. 31.1 % ) .


Nonetheless , improvement in the respective scores was greater in the PRP than bupivacaine group after 3 months ( 42.5 % vs. 30.9 % , 34.1 % vs. 27.2 % , and 50.7 % vs. 39.6 % ) , 6 months ( 67.3 % vs. 20.1 % , 40.6 % vs. 16.3 % , and 71.4 % vs. 31.1 % ) , and one year ( 83.2 % vs. 45.6 % , 47.0 % vs. 21.7 % , and 76.6 % vs. 56.3 % ) .


The differences in scores between groups were significant at 6 months and one year only ( p < 0.001 ) .


Leukocyte-poor ( type-4 ) PRP injection for recalcitrant LET enabled good improvement in pain and function .


Smoking cessation is a high-priority intervention to prevent CVD events and deaths in developing countries .


While several interventions to stop smoking have been proved successful , the question of how to increase their effectiveness and practicality in developing countries remains .


In this study , a newly devised evidence-based smoking cessation service package will be compared with the existing service in a randomized controlled trial within the community setting of Thailand .


This randomized control trial will recruit 440 current smokers at CVD risk because of being diabetic and/or hypertensive .


Informed , consented participants will be randomly allocated into the new service-package arm and the routine service arm .


The study will take place in the non-communicable disease clinics of the Maetha District Hospital , Lampang , northern Thailand .


The new smoking-cessation service-package comprises ( 1 ) regular patient motivation and coaching from the same primary care nurse over a 3-month period ; ( 2 ) monthly application of piCO + smokerlyzer to sustain motivation of smoker 's quitting attempt and provide positive feedback over a 3-month period ; ( 3 ) assistance by an assigned family member ; ( 4 ) nicotine replacement chewing gum to relieve withdrawal symptoms .


This new service will be compared with the traditional routine service comprising the 5A approach in a 1-year follow-up .


Participants who consent to participate in the study but refuse to attempt quitting smoking will be allocated to the non-randomized arm , where they will be just followed up and monitored .


Primary outcome of the study is smoking cessation rate at 1-year follow-up proven by breath analysis measuring carbomonoxide in parts per million in expired air .


Secondary outcomes are smoking cessation rate at the 6-month follow-up , blood pressure and heart rate , CVD risk according to the Framingham general cardiovascular risk score , CVD events and deaths at the 12-month follow-up , and the cost-effectiveness of the health service packages .


Intention-to-treat analysis will be followed .


Factors influencing smoking cessation will be analyzed by the structure equation model .


This multicomponent intervention , accessible at primary healthcare clinics , and focusing on the individual as well as the family and social environment , is unique and expected to work effectively .


Current Controlled Trials ISRCTN89315117 .


Facing frequent stigma and discrimination , many people with mental illness have to choose between secrecy and disclosure in different settings .


Coming Out Proud ( COP ) , a 3-week peer-led group intervention , offers support in this domain in order to reduce stigma 's negative impact .


To examine COP 's efficacy to reduce negative stigma-related outcomes and to promote adaptive coping styles ( Current Controlled Trials number : ISRCTN43516734 ) .


In a pilot randomised controlled trial , 100 participants with mental illness were assigned to COP or a treatment-as-usual control condition .


Outcomes included self-stigma , empowerment , stigma stress , secrecy and perceived benefits of disclosure .


Intention-to-treat analyses found no effect of COP on self-stigma or empowerment , but positive effects on stigma stress , disclosure-related distress , secrecy and perceived benefits of disclosure .


Some effects diminished during the 3-week follow-up period .


Coming Out Proud has immediate positive effects on disclosure - and stigma stress-related variables and may thus alleviate stigma 's negative impact .


Highly cross-linked polyethylene infused with vitamin E ( E-poly ) was developed to increase oxidative resistance without affecting mechanical properties .


We evaluated this type of polyethylene in a randomized clinical study that used radiostereometric analysis .


Our objective was to compare the early-term femoral head penetration of an E-poly liner with that of a heat-treated polyethylene liner , ArComXL .


We hypothesized that the clinical outcome at two years following total hip arthroplasty would be unaffected by the choice of polyethylene .


In this prospective study , sixty-one patients ( seventy hips ) with noninflammatory hip osteoarthritis and a median age of fifty-eight years were randomized to receive either an implant with an E-Poly or a heat-treated highly cross-linked polyethylene liner .


The patients were followed for two years and evaluated at three time points ( three months , one year , and two years ) .


The median proximal penetration in the E-poly group increased from 0.04 mm at three months to 0.06 mm at two years of follow-up .


Corresponding values for the ArComXL group were 0.03 mm and 0.10 mm .


In both groups , significantly increased penetration was observed between three months and two years ( E-poly , p = 0.02 ; ArComXL , p < 0.001 ) , but between one and two years , the increase was significant only in the control group ( E-poly , p = 0.23 ; ArComXL , p = 0.002 ) .


The femoral head penetration of E-poly was very low at two years .


Whether the increase observed between three months and two years was caused by creep , deformation , wear , or a combination of these can not be determined by our study .


There were no significant differences observed in femoral head penetration rates between E-poly and ArComXL .


Currently , the theoretical advantages of E-poly remain to be confirmed .


trans Palmitoleic acid ( t-16 :1 n-7 , or 16:1 t9 in the nomenclature usually applied to trans fatty acids and used herein ) arouses great scientific interest because it has been suggested to serve as a biomarker for lower risks of type 2 diabetes and coronary artery disease .


Although 16:1 t9 has been assumed to derive from dietary sources , we examined the hypothesis that 16:1 t9 might also be endogenously produced from its metabolic precursor vaccenic acid ( t-18 :1 n-7 or 18:1 t11 ) .


We reevaluated fatty acid data obtained from one human intervention study and one cellular model in both of which 18:1 t11 was supplemented .


Both studies have already been published , but to our knowledge , 16:1 t9 has not yet been considered .


This reanalysis of the datasets was reasonable because a new methodology for identifying 16:1 cis and trans isomers allowed us to address the subject presented in this article .


Data showed that the systemic or intracellular increase in 16:1 t9 was strongly correlated with the increase in 18:1 t11 after the dietary intake or cellular uptake of 18:1 t11 .


The conversion rate in humans was , on average , 17 % .


Our findings suggest that endogenous 16:1 t9 is not , as has been assumed , exclusively diet derived but may also be produced by the partial oxidation of dietary 18:1 t11 .


To determine the effectiveness of personal digital assistant devices on achievement of memory and organization goals in patients with poor memory after acquired brain injury .


Assessor blinded randomized controlled trial .


Specialist brain injury rehabilitation hospital ( inpatients and outpatients ) .


Adults with acquired brain impairments ( 85 % traumatic brain injury ; aged 17 years ) who were assessed as having functional memory impairment on the Rivermead Behavioural Memory Test ( General Memory Index ) .


Training and support to use a personal digital assistant for eight weeks to compensate for memory failures by an occupational therapist .


The control intervention was standard rehabilitation , including use of non-electronic memory aids .


Goal Attainment Scale which assessed achievement of participants ' daily memory functioning goals and caregiver perception of memory functioning ; and General Frequency of Forgetting subscale of the Memory Functioning Questionnaire administered at baseline ( pre-randomization ) and post intervention ( eight weeks later ) .


Forty-two participants with memory impairment were recruited .


Use of a personal digital assistant led to greater achievement of functional memory goals ( mean difference 1.6 ( 95 % confidence interval ( CI ) 1.0 to 2.2 ) , P = 0.0001 ) and improvement on the General Frequency of Forgetting subscale ( mean difference 12.5 ( 95 % CI 2.0 to 22.9 ) , P = 0.021 ) .


Occupational therapy training in the use of a handheld computer improved patients ' daily memory function more than standard rehabilitation .


In searching for an optimal induction regimen , we conducted two separate randomized trials of 38 living donor and 90 deceased donor adult , primary kidney transplant recipients comparing antithymocyte globulin ( Thymoglobulin ) ( group A , N = 43 ) versus alemtuzumab ( group B , N = 43 ) versus daclizumab ( group C , N = 42 ) , using exactly the same three treatment arms in each trial .


For the purpose of maximizing statistical power , results from the two randomized trials were combined .


Groups A and C received standard maintenance dosing with tacrolimus ( TAC ) , mycophenolate mofetil ( MMF ) , and corticosteroids .


Because of intense lymphodepletion expected with alemtuzumab use ( and hoped-for achievement of a truer immunoregulatory state ) , group B received lower TAC and MMF dosing and corticosteroid avoidance .


Long-term target TAC trough level and MMF dosing were 5 to 7 ng/mL and 1,000 mg b.i.d. in groups A and C ; 4 to 6 ng/mL and 500 mg b.i.d. in group B.


With median follow-up of 95 months , biopsy-proven cute rejection incidence was similar in the three groups ( 8/43 , 14/43 , and 12/42 , P = 0.34 ) , but biopsy-proven chronic allograft injury incidence was significantly higher in group B ( 19/43 ) in comparison with groups A ( 9/43 ) and C ( 7/42 ) combined ( P = 0.0008 ) .


Mean calculated creatinine clearance was significantly lower in group B versus the average of groups A and C means throughout 60 months posttransplant ( 62.94.2 vs. 83.66.9 and 79.85.9 at 60 months , P = 0.01 ) , and death-censored graft failure was significantly higher in group B ( 13/43 ) versus groups A ( 5/43 ) and C ( 5/42 ) combined ( P = 0.009 ) .


Total infection and new-onset diabetes after transplant rates were not significantly different .


Ad hoc analysis suggested that the inferior results in group B were specifically a result of reduced dosing and greater withholding of TAC and MMF occurring in that group .


Long-term results clearly indicate inferior clinical outcomes in group B.


In the past , bilateral contralateral routing of signals ( BICROS ) amplification incorporated omnidirectional microphones on the transmitter and receiver sides and some models utilized noise reduction ( NR ) on the receiver side .


Little research has examined the performance of BICROS amplification in background noise .


However , previous studies examining contralateral routing of signals ( CROS ) amplification have reported that the presence of background noise on the transmitter side negatively affected speech recognition .


Recently , NR was introduced as a feature on the receiver and transmitter sides of BICROS amplification , which has the potential to decrease the impact of noise on the wanted speech signal by decreasing unwanted noise directed to the transmitter side .


The primary goal of this study was to examine differences in the reception threshold for sentences ( RTS in dB ) using the Hearing in Noise Test ( HINT ) in a diffuse listening environment between unaided and three aided BICROS conditions ( no NR , mild NR , and maximum NR ) in the Tandem 16 BICROS .


A secondary goal was to examine real-world subjective impressions of the Tandem 16 BICROS compared to unaided .


A randomized block repeated measures single blind design was used to assess differences between no NR , mild NR , and maximum NR listening conditions .


Twenty-one adult participants with asymmetric sensorineural hearing loss ( ASNHL ) and experience with BICROS amplification were recruited from Washington University in St. Louis School of Medicine .


Participants were fit with the National Acoustic Laboratories ' Nonlinear version 1 prescriptive target ( NAL-NL1 ) with the Tandem 16 BICROS at the initial visit and then verified using real-ear insertion gain ( REIG ) measures .


Participants acclimatized to the Tandem 16 BICROS for 4 wk before returning for final testing .


Participants were tested utilizing HINT sentences examining differences in RTS between unaided and three aided listening conditions .


Subjective benefit was determined via the Abbreviated Profile of Hearing Aid Benefit ( APHAB ) questionnaire between the Tandem 16 BICROS and unaided .


A repeated measures analysis of variance ( ANOVA ) was utilized to analyze the results of the HINT and APHAB .


Results revealed no significant differences in the RTS between unaided , no NR , mild NR , and maximum NR .


Subjective impressions using the APHAB revealed statistically and clinically significant benefit with the Tandem 16 BICROS compared to unaided for the Ease of Communication ( EC ) , Background Noise ( BN ) , and Reverberation ( RV ) subscales .


The RTS was not significantly different between unaided , no NR , mild NR , and maximum NR .


None of the three aided listening conditions were significantly different from unaided performance as has been reported for previous studies examining CROS hearing aids .


Further , based on comments from participants and previous research studies with conventional hearing aids , manufacturers of BICROS amplification should consider incorporating directional microphones and independent volume controls on the receiver and transmitter sides to potentially provide further improvement in signal-to-noise ratio ( SNR ) for patients with ASNHL .


To determine the effectiveness of a client or care-provider strategy to improve the implementation of external cephalic version .


Cluster randomized controlled trial .


Twenty-five clusters ; hospitals and their referring midwifery practices randomly selected in the Netherlands .


Singleton breech presentation from 32 weeks of gestation onwards .


We randomized clusters to a client strategy ( written information leaflets and decision aid ) , a care-provider strategy ( 1-day counseling course focused on knowledge and counseling skills ) , a combined client and care-provider strategy and care-as-usual strategy .


We performed an intention-to-treat analysis .


Rate of external cephalic version in various strategies .


Secondary outcomes were the percentage of women counseled and opting for a version attempt .


The overall implementation rate of external cephalic version was 72 % ( 1169 of 1613 eligible clients ) with a range between clusters of 8-95 % .


Neither the client strategy ( OR 0.8 , 95 % CI 0.4-1 .5 ) nor the care-provider strategy ( OR 1.2 , 95 % CI 0.6-2 .3 ) showed significant improvements .


Results were comparable when we limited the analysis to those women who were actually offered intervention ( OR 0.6 , 95 % CI 0.3-1 .4 and OR 2.0 , 95 % CI 0.7-4 .5 ) .


Neither a client nor a care-provider strategy improved the external cephalic version implementation rate for breech presentation , neither with regard to the number of version attempts offered nor the number of women accepting the procedure .


Balance dysfunction after stroke limits patients ' general function and participation in daily life .


Previous researches have suggested that Tai Chi exercise could offer a positive improvement in older individuals ' balance function and reduce the risk of falls .


But convincing evidence for the effectiveness of enhancing balance function after stroke with Tai Chi exercise is still inadequate .


Considering the difficulties for stroke patients to complete the whole exercise , the current trial evaluates the benefit of Tai Chi Yunshou exercise for patients with balance dysfunction after stroke through a cluster randomization , parallel-controlled design .


A single-blind , cluster-randomized , parallel-controlled trial will be conducted .


A total of 10 community health centers ( 5 per arm ) will be selected and randomly allocated into Tai Chi Yunshou exercise group or balance rehabilitation training group .


Each community health centers will be asked to enroll 25 eligible patients into the trial .


60minutes per each session , 1 session per day , 5 times per week and the total training round is 12weeks .


Primary and secondary outcomes will be measured at baseline and 4-weeks , 8-weeks , 12-weeks , 6-week follow-up , 12-week follow-up after randomization .


Safety and economic evaluation will also be assessed .


This protocol aims to evaluate the effectiveness of Tai Chi Yunshou exercise for the balance function of patients after stroke .


If the outcome is positive , this project will provide an appropriate and economic balance rehabilitation technology for community-based stroke patients .


Chinese Clinical Trial Registry : ChiCTR-TRC-13003641 .


Registration date : 22 August , 2013 http://www.chictr.org/usercenter/project/listbycreater.aspx .


Smoking and metabolic syndrome ( MetS ) are major public health problems in modern society and are important risk factors of cardiovascular disease ( CVD ) .


The association of smoking , MetS , and CVD is widely reported , but reports targeted to women are few .


In the present study , we evaluated risk factors , including visceral fat area ( VFA ) , for CVD and development of subclinical atherosclerosis in female smokers especially .


Subjects consisted of 162 apparent healthy female and male smokers , and 315 age-matched never-smokers who underwent a health examination in the Osaka University Health Care Center .


For female smokers , lifestyle and carotid intima-media thickness ( IMT ) were evaluated .


Triglycerides were significantly higher and high-density lipoprotein-cholesterol significantly lower in smokers than in never-smokers for both men and women .


However , VFA was significantly high only in smoking women when compared with never-smokers .


Multivariate analysis revealed that age , body mass index , and smoking were the independent predictors of high VFA in women .


In addition , annual IMT increase was significantly higher in smokers than never-smokers in women .


VFA was notably high in female smokers , but the difference was not observed in men .


Smoking habit is an important risk factor of visceral fat accumulation and progression of subclinical atherosclerosis in women .


Many tools have been developed to facilitate the insertion of the ProSeal laryngeal mask airway ( LMA ) insertion , which can be impeded by folding of its soft cuff .


The aim of this study was to compare the efficiency of ProSeal LMA insertion guided by a soft , direct optical Foley Airway Stylet Tool ( FAST ) with the standard introducer tool ( IT ) .


One hundred sixty patients undergoing general anesthesia using the ProSeal LMA as an airway management device were randomly allocated to either FAST-guided or IT-assisted groups .


Following ProSeal LMA insertion , the glottic and esophageal openings were identified using a fiberoptic bronchoscope introduced through the airway and the drain tube .


The primary outcomes were time taken to insert the ProSeal LMA and the success rate at the first attempt .


Secondary end points included ease of insertion , hemodynamic response to insertion , and postoperative adverse events recorded in the recovery room and on the first postoperative morning .


One hundred forty patients were included in the final analysis : 66 in the FAST-guided group and 74 in the IT-assisted group .


The success rate of FAST device-guided ProSeal LMA insertion ( 95.7 % ) was broadly comparable with IT-assisted insertion ( 98.7 % ) .


However , the time taken to insert the ProSeal LMA was significantly longer when the FAST technique was used ( p < 0.001 ) .


The incidence of correct alignment of the airway tube and the drain tube did not differ significantly between the groups .


There were no significant differences in ease of insertion or hemodynamic responses to insertion , except that the incidence of postoperative sore throat was significantly higher in the FAST group on the first postoperative day ( 22.2 % compared with 6.8 % in the IT group ; p = 0.035 ) .


Both FAST-guided and IT-assisted techniques achieved correct ProSeal LMA positioning , but the IT technique was significantly quicker and less likely to cause a sore throat .


ClinicalTrials.gov Identifier : NCT02048657 .


The best available treatment for seasonal affective disorder ( SAD ) is light therapy .


Yet , this treatment does not prevent recurrence of depression in subsequent seasons .


The aim of the study is to gain preliminary insight in the efficacy of Mindfulness Based Cognitive Therapy ( MBCT ) in the prevention of SAD recurrence .


This is a randomized controlled pilot study , in which SAD patients in remission were randomly allocated to an individual format of MBCT or a control condition ( i.e. treatment as usual ) .


MBCT was given between May and June 2011 , when there was no presence of depressive symptoms .


The Inventory for Depressive Symptomatology Self-Report ( IDS-SR ) , which patients received on a weekly basis from September 2011 to April 2012 , was used to assess moment of recurrence ( 20 ) and severity at moment of recurrence .


23 SAD patients were randomized to MBCT and 23 to the control condition .


Kaplan-Meier survival curve showed that the groups did not differ in moment of recurrence ( ( 1 ) .41 , p = .52 ) .


T-tests showed no group difference in mean IDS-SR scores at moment of recurrence ( t ( 31 ) = -.52 , p = .61 ) .


The results are limited by small sample size ( n = 46 ) and missing data of weekly IDS-SR assessments .


The findings of this pilot RCT suggest that individual MBCT is not effective in preventing a SAD recurrence when offered in a symptom free period ( i.e. spring ) .


To determine the effectiveness of an individually targeted Internet-based intervention with monetary incentives ( INCENT ) at reducing weight of overweight and obese employees when compared with a less-intensive intervention ( Livin ' My Weigh [ LMW ] ) 6 months after program initiation .


Twenty-eight worksites were randomly assigned to either INCENT or LMW conditions .


Both programs used evidence-based strategies to support weight loss .


INCENT was delivered via daily e-mails over 12 months while LMW was delivered quarterly via both newsletters and on-site educational sessions .


Generalized linear mixed models were conducted for weight change from baseline to 6 months post-program and using an intention-to-treat analysis to include all participants with baseline weight measurements .


Across 28 worksites , 1,790 employees ( M = 47 years of age ; 79 % Caucasian ; 74 % women ) participated .


Participants lost an average of 2.27 lbs ( P < 0.001 ) with a BMI decrease of 0.36 kg/m ( 2 ) ( P < 0.001 ) and 1.30 lbs ( P < 0.01 ) with a BMI decrease of 0.20 kg/m ( 2 ) ( P < 0.01 ) in INCENT and LMW , respectively .


The differences between INCENT and LMW in weight loss and BMI reduction were not statistically significant .


This study suggests that INCENT and a minimal intervention alternative may be effective approaches to help decrease the overall obesity burden within worksites .


To evaluate the efficacy and safety of etanercept in patients with enthesitis-related arthritis ( ERA ) in juvenile idiopathic arthritis ( JIA ) .


This was a 2-phase study in JIA patients with active , refractory ERA .


Phase I was an open-label , uncontrolled 24-week study period in which all patients were administered etanercept .


Patients considered to be treatment responders at week 24 according to the American College of Rheumatology ( ACR ) Pediatric 30 ( Pedi 30 ) criteria for improvement in juvenile arthritis entered the second phase , a 24-week randomized , double-blind , placebo-controlled withdrawal study , for an additional 24 weeks , for evaluation of the primary end point , occurrence of a disease flare from week 24 to week 48 , based on the ACR preliminary definition of disease flare in juvenile arthritis .


Forty-one patients were enrolled .


At week 24 , treatment with etanercept resulted in response rates of 93 % , 93 % , 80 % , 56 % , and 54 % based on the ACR Pedi 30 , Pedi 50 , Pedi 70 , Pedi 90 , and Pedi 100 criteria , respectively .


In addition , a marked decrease in all disease activity measures was observed .


The mean number of tender joints , swollen joints , and joints with active arthritis decreased by 91 % , 97 % , and 94 % , respectively .


Physician 's global assessment of disease activity , parent 's assessment of patient 's overall well-being , and the Childhood Health Assessment Questionnaire disability index improved by 91 % , 80 % , and 86 % , respectively .


The number of tender enthesis sites and total scores for back pain , nocturnal pain , Bath Ankylosing Spondylitis Disease Activity Index , Bath Ankylosing Spondylitis Functional Index , and Juvenile Arthritis Disease Activity Score based on 10-joint counts ( JADAS10 ) decreased by 75 % , 72 % , 81 % , 72 % , 85 % , and 87 % , respectively .


In phase II , 38 patients were randomly assigned to receive placebo ( n = 18 ) or to continue receiving etanercept ( n = 20 ) .


Up to week 48 , 12 disease flares occurred , in 9 patients receiving placebo and 3 patients receiving etanercept ( odds ratio 6.0 , P = 0.02 ) .


There were no serious infections , malignancies , or deaths .


In this study of patients with the ERA category of JIA , etanercept proved effective , as indicated by high ACR Pedi response rates and JADAS10 response rates at week 24 .


Patients who continued treatment with etanercept had significantly fewer flares than those who received placebo , although 50 % of patients in the placebo group did not experience a flare .


Treatment suspension may be a consideration for patients with the ERA category of JIA who achieve remission .


Lactase non-persistence ( LNP ) , or primary hypolactasia , is a genetic condition that mediates lactose malabsorption and can cause lactose intolerance .


Here we report the prevalence of lactose intolerance in a double-blind placebo study .


The LCT C > T-13910 variant was genotyped by RT-PCR in 121 volunteers and lactose malabsorption was assessed using the hydrogen breath test ( HBT ) after consuming 25 g of lactose .


Lactose intolerance was assessed by scoring symptoms ( SS ) using a standardized questionnaire following challenge with a lactose solution or saccharose placebo .


The LNP genotype was observed in 57 % of the volunteers , among whom 87 % were HBT .


In the HBT group the median SS was 9 and in the HBT group the median SS was 3 ( p < 0.001 ) .


No difference was observed in the SS when both groups were challenged with the placebo .


The most common symptoms included audible bowel sounds , abdominal pain and meteorism .


In the ROC curve analysis , an SS 6 demonstrated 72 % sensitivity and 81 % specificity for predicting a positive HBT .


To estimate prevalence , lactose intolerance was defined as the presence of an SS 6 points after subtracting the placebo effect and 34 % of the study population met this definition .


The LNP genotype was present in more than half of subjects evaluated and the observed prevalence of lactose intolerance was 34 % .


We performed a randomised trial in very preterm , small for gestational age ( SGA ) babies to determine if prophylaxis with granulocyte macrophage colony stimulating factor ( GM-CSF ) improves outcomes ( the PROGRAMS trial ) .


GM-CSF was associated with improved neonatal neutrophil counts , but no change in other neonatal or 2-year outcomes .


As subtle benefits in outcome may not be ascertainable until school age we performed an outcome study at 5years .


280 babies born at 31weeks of gestation or less and SGA were entered into the trial .


Outcomes were assessed at 5years to determine neurodevelopmental and general health status and educational attainment .


We found no significant differences in cognitive , general health or educational outcomes between 83 of 106 ( 78 % ) surviving children in the GM-CSF arm compared with 81 of 110 ( 74 % ) in the control arm .


Mean mental processing composite ( equivalent to IQ ) at 5years were 94 ( SD 16 ) compared with 95 ( SD 15 ) , respectively ( difference in means -1 ( 95 % CI -6 to 4 ) , and similar proportions were in receipt of special educational needs support ( 41 % vs 35 % ; risk ratio 1.2 ( 95 % CI 0.8 to 1.9 ) ) .


Performance on Kaufmann-ABC subscales and components of NEPSY were similar .


The suggestion of worse respiratory outcomes in the GM-CSF group at 2years was replicated at 5years .


The administration of GM-CSF to very preterm SGA babies is not associated with improved or more adverse neurodevelopmental , general health or educational outcomes at 5years .


ISRCTN42553489 .


Today 's children are more overweight than previous generations and physical inactivity is a contributing factor .


Modelling and promoting positive behaviour in the early years is imperative for the development of lifelong health habits .


The social and physical environments where children spend their time have a powerful influence on behaviour .


Since the majority of preschool children spend time in care outside of the home , this provides an ideal setting to examine the ability of an intervention to enhance movement skills and modify physical activity behaviour .


This study aims to evaluate the efficacy of the Activity Begins in Childhood ( ABC ) intervention delivered in licensed daycare settings alone or in combination with a parent-driven home physical activity-promotion component to increase preschoolers ' overall physical activity levels and , specifically , the time spent in moderate to vigorous physical activity .


This study is a single site , three-arm , cluster-randomized controlled trial design with a daycare centre as the unit of measurement ( clusters ) .


All daycare centres in the National Capital region that serve children between the ages of 3 and 5 , expressing an interest in receiving the ABC intervention will be invited to participate .


Those who agree will be randomly assigned to one of three groups : i ) ABC program delivered at a daycare centre only , ii ) ABC program delivered at daycare with a home/parental education component , or iii ) regular daycare curriculum .


This study will recruit 18 daycare centres , 6 in each of the three groups .


The intervention will last approximately 6months , with baseline assessment prior to ABC implementation and follow-up assessments at 3 and 6months .


Physical activity is an acknowledged component of a healthy lifestyle and childhood experiences as it has an important impact on lifelong behaviour and health .


Opportunities for physical activity and motor development in early childhood may , over the lifespan , influence the maintenance of a healthy body weight and reduce cardiovascular disease risk .


If successful , the ABC program may be implemented in daycare centres as an effective way of increasing healthy activity behaviours of preschoolers .


Current Controlled Trials : ISRCTN94022291 .


Registered in December 2012 , first cluster randomized in April 2013 .


To observe the impact of plant sterol esters ( PSE ) mixed in low fat milk powder ( 2.5 g of PSE/day ) on plasma cholesterol levels in hypercholesterolemic subjects during a 6-week intervention period .


In this double-blind , randomized , placebo-controlled study , 59 subjects ( 19 males , mean age ( 60.28 6.98 ) years ) with primary hypercholesterolemia ( fasting LDL cholesterol between 3.4-6 .0 mmol/L ) were randomly divided into two groups ( treatment group , 2.5 g of plant sterol esters a day , n = 30 ) and placebo group ( n = 29 ) .


Blood samples were collected at week 0 , 3 and 6 .


The primary outcome was change in plasma LDL-cholesterol ( LDL-C ) .


Secondary outcomes were changes in total cholesterol ( TC ) , HDL cholesterol ( HDL-C ) , triglycerides ( TG ) , anthropometry and blood biochemistry .


LDL-C significantly reduction from baseline ( 4.18 0.54 ) mmol/L to ( 3.44 0.61 ) mmol/L ( -17.7 % , P < 0.05 ) at week 3 and ( 3.35 0.39 ) mmol/L ( -19.9 % , P < 0.05 ) at week 6 in the treatment group , whereas in placebo group from ( 4.11 0.54 ) mmol/L at baseline to ( 3.47 0.60 ) mmol/L ( -15.57 % , P < 0.05 ) and ( 3.61 0.39 ) mmol/L ( -12.17 % , P < 0.05 ) at week 3 and week 6 , respectively .


TC was reduced from ( 6.30 0.86 ) mmol/L at baseline to ( 5.92 0.75 ) mmol/L ( -6.03 % , P > 0.05 ) at week 3 and ( 5.43 0.77 ) mmol/L ( -13.8 % , P < 0.05 ) at week 6 in treatment group , from ( 6.20 0.76 ) mmol/L at week 0 to ( 5.70 0.76 ) mmol/L ( -8.06 % , P < 0.05 ) at week 3 and ( 5.84 0.75 ) mmol/L ( -5.81 % , P < 0.05 ) at week 6 in placebo group .


PSE-enriched milk did not affect plasma HDL-C level and TG level at both week 3 and week 6 .


After normalization to the placebo group , the treatment group showed significant reduction in LDL-C and total cholesteron after 6 weeks .


The observed difference of reduction was 7.69 % ( -0.33 mmol/L , P < 0.05 ) for LDL-C and 8.00 % ( -0.51 mmol/L , P < 0.05 ) for TC between the two groups .


There were no significant changes in safety parameters , including blood biochemistry tests during the study period .


Plant sterol ester enriched milk powder is effective in reducing LDL-C among Chinese hypercholesterolemic subjects at a dosage recommended by EFSA .


One of the most dreaded complications of septic shock is acute kidney injury .


It occurs in around 50 % of patients , with a mortality rate of about 60 % at 3 months .


There is no consensus on the optimal time to initiate renal replacement therapy .


Retrospective and observational studies suggest that early implementation of renal replacement therapy could improve the prognosis for these patients .


This protocol summarizes the rationale and design of a randomized , controlled , multicenter trial investigating the effect of early versus delayed renal replacement therapy in patients with severe acute kidney injury in early septic shock .


In total , 864 critically ill adults with septic shock and evidence of acute kidney injury , defined as the failure stage of the RIFLE classification , will be enrolled .


The primary outcome is mortality at 90 days .


Secondary outcomes include safety , number of days free of mechanical ventilation , number of days free of renal replacement therapy , intensive care length of stay , in-hospital length of stay , quality of life as evaluated by the EQ-5D and renal replacement therapy dependence at hospital discharge .


The primary analysis will be intention to treat .


Recruitment started in March 2012 and will be completed by March 2015 .


This protocol for a randomized controlled study investigating the impact of the timing of renal replacement therapy initiation should provide an answer to a key question for the management of patients with acute kidney injury in the context of septic shock , for whom the mortality rate remains close to 60 % despite improved understanding of physiopathology and recent therapeutic advances .


ClinicalTrials.gov identifier NCT01682590 , registered on 10 September 2012 .


To investigate the safety and efficacy of low-concentration inhaled nitric oxide ( NO ) in the treatment of hypoxic respiratory failure ( HRF ) among premature infants .


Sixty premature infants ( gestational age 34 weeks ) with HRF were randomized into NO and control groups between 2012 and 2013 , with 30 cases in each group .


Both groups received nasal continuous positive airway pressure ( nCPAP ) or mechanical ventilation .


NO inhalation was continued for at least 7 days or until weaning in the NO group .


The general conditions , blood gas results , complications , and clinical outcomes of the two groups were analyzed .


The NO group showed significantly more improvement in blood gas results than the control group after 12 hours of treatment ( P < 0.05 ) .


After that , the change in oxygenation status over time showed no significant difference between the two groups ( P > 0.05 ) .


There were no significant differences in total time of assisted ventilation and duration of oxygen therapy between the two groups ( P > 0.05 ) .


The incidence of bronchopulmonary dysplasia ( BPD ) , patent ductus arteriosus , necrotizing enterocolitis , retinopathy of prematurity , and pneumothorax in infants showed no significant differences between the NO and control groups ( P > 0.05 ) , but the incidence of IVH and mortality were significantly lower in the NO group than in the control group ( 7 % vs 17 % , P < 0.05 ; 3 % vs 13 % , P < 0.05 ) .


NO inhalation may improve oxygenation status and reduce the mortality in premature infants with HRF , but it can not reduce the incidence of BPD and the total time of mechanical ventilation or nCPAP and duration of oxygen therapy .


NO therapy may have a brain-protective effect for premature infants with HRF and does not increase clinical complications .


To explore the clinical efficacies of different internal fixation materials in the treatment of senile proximal humerus fractures .


A total of 284 hospitalized patients of proximal humerus fractures over 60 years of age cases from October 2009 to February 2012 were randomly divided into two groups of locking proximal humeral plate ( LPHP ) and PHILOS ( n = 142 each ) .


And the clinical efficacies of two groups were compared .


For PHILOS and LPHP groups , the fracture healing periods were ( 11.64 3.81 ) and ( 14.95 3.95 ) weeks .


And there was statistical significance ( P < 0.05 ) .


At 3 months post-surgery , the incidence of pain was 72.41 % and 64.81 % .


At 2 years , Neer shoulder function score had inter-group statistically insignificant difference ( P > 0.05 ) .


Both PHILOS and LPHP are effective in the treatment of senile proximal humeral fractures.However , the former is conducive to fracture healing and has shorter healing time and lowered postoperative pain .


Few studies have addressed the rehabilitation of hand function in persons with severe impairment following stroke , and few therapeutic options are available for treatment .


We investigated whether an intervention of robot-assisted movement and muscle vibration could reduce impairment and enable hand-opening to a greater extent when combined with torque biofeedback or electromyographic ( EMG ) biofeedback .


Forty-three participants with severe hand impairment due to chronic stroke ( 1 year poststroke ) were randomized to 1 of 2 treatment groups receiving assisted movement and muscle vibration combined with either torque or EMG biofeedback .


Each participant received 30 sessions ( 30 minutes duration per session ) directed at the impaired hand over 10 to 12 weeks .


Outcomes were assessed using the Upper Extremity Fugl-Meyer Assessment ( UE-FMA ) , Stroke Impact Scale , and Box-and-Block Test scores .


Twenty-eight of 43 participants had no baseline finger extension ; the remainder had an average of 23 26 mm extension in the most active finger .


Assisted movement and muscle vibration were associated with a significant increase in all outcome measures across both treatment groups , and for the UE-FMA and Stroke Impact Scale within treatment groups , with no significant difference between groups .


Based on the Box-and-Block Test scores , the assisted movement and muscle vibration intervention did not restore functional hand-opening to participants with baseline UE-FMA scores less than 17/66 , regardless of the form of biofeedback .


Assisted movement and muscle vibration , combined with either EMG or torque biofeedback , appears to reduce upper limb impairment , improve volitional activation of the hand muscles , and restore a modicum of hand function in some persons with severe hand impairment due to chronic stroke.Video Abstract available ( see Video , Supplemental Digital Content 1 , http://links.lww.com/JNPT/A64 ) for more insights from the authors .


The optimal perioperative blood glucose range to improve surgical site infection ( SSI ) in surgical intensive care unit ( ICU ) patients remains unclear .


We sought to determine whether the incidence of SSI is reduced by perioperative intensive insulin therapy ( IT ) .


Patients were randomly assigned to receive perioperative intensive IT , with a target blood glucose range of 4.4-6 .1 mmol/L , or intermediate IT , with a target blood glucose range of 7.7-10 .0 mmol/L in the surgical ICU .


We defined the primary end point as the incidence of SSI .


Study participants were randomly assigned to glucose control with one of two target ranges : for 225 patients in the intermediate IT group or for 222 patients in the intensive IT group , respectively .


No patients in either group became hypoglycemic ( < 4.4 mmol/L ) during their stay in the surgical ICU .


In our series , the rate of SSI after hepato-biliary-pancreatic surgery was 6.7 % .


Patients in the intensive IT group , compared with the intermediate IT group , had fewer postoperative SSIs ( 9.8 % vs. 4.1 % , P = 0.028 ) and a lower incidence of postoperative pancreatic fistula after pancreatic resection ( P = 0.040 ) .


The length of hospitalization required for patients in the intensive IT group was significantly shorter than that in the intermediate IT group ( P = 0.017 ) .


We found that intensive IT decreased the incidence of SSI among patients who underwent hepato-biliary-pancreatic surgery : a blood glucose target of 4.4 to 6.1 mmol/L resulted in lower rate of SSI than did a target of 7.7-10 .0 mmol/L .


Phylogenetic comparative analyses usually rely on a single consensus phylogenetic tree in order to study evolutionary processes .


However , most phylogenetic trees are incomplete with regard to species sampling , which may critically compromise analyses .


Some approaches have been proposed to integrate non-molecular phylogenetic information into incomplete molecular phylogenies .


An expanded tree approach consists of adding missing species to random locations within their clade .


The information contained in the topology of the resulting expanded trees can be captured by the pairwise phylogenetic distance between species and stored in a matrix for further statistical analysis .


Thus , the random expansion and processing of multiple phylogenetic trees can be used to estimate the phylogenetic uncertainty through a simulation procedure .


Because of the computational burden required , unless this procedure is efficiently implemented , the analyses are of limited applicability .


In this paper , we present efficient algorithms and implementations for randomly expanding and processing phylogenetic trees so that simulations involved in comparative phylogenetic analysis with uncertainty can be conducted in a reasonable time .


We propose algorithms for both randomly expanding trees and calculating distance matrices .


We made available the source code , which was written in the C++ language .


The code may be used as a standalone program or as a shared object in the R system .


The software can also be used as a web service through the link : http://purl.oclc.org/NET/sunplin/ .


We compare our implementations to similar solutions and show that significant performance gains can be obtained .


Our results open up the possibility of accounting for phylogenetic uncertainty in evolutionary and ecological analyses of large datasets .


We compared the effect of clopidogrel plus aspirin vs aspirin alone on functional outcome and quality of life in the Clopidogrel in High-risk Patients with Acute Non-disabling Cerebrovascular Events ( CHANCE ) trial of aspirin-clopidogrel vs aspirin alone after acute minor stroke or TIA .


Participants were assessed at 90 days for functional outcome using the modified Rankin Scale ( mRS ) and quality of life using the EuroQol-5 Dimension ( EQ-5D ) .


Poor functional outcome was defined as mRS score of 2-6 at 90 days and poor quality of life as EQ-5D index score of 0.5 or less .


Poor functional outcome occurred in 254 patients ( 9.9 % ) in the clopidogrel-aspirin group , as compared with 299 ( 11.6 % ) in the aspirin group ( p = 0.046 ) .


Poor quality of life occurred in 142 ( 5.5 % ) in the clopidogrel-aspirin group and in 175 ( 6.8 % ) in the aspirin group ( p = 0.06 ) .


Disabling stroke at 90 days occurred in 166 ( 6.5 % ) in the clopidogrel-aspirin group and in 219 ( 8.5 % ) in the aspirin group ( p = 0.01 ) .


In stratified analysis by subsequent stroke , there was no difference in 90-day functional outcome and quality of life between the 2 groups .


In patients with minor stroke or TIA , the combination of clopidogrel and aspirin appears to be superior to aspirin alone in improving the 90-day functional outcome , and this is consistent with a reduction in the rate of disabling stroke in the dual antiplatelet arm .


This study provides Class II evidence that for patients with acute minor stroke or TIA , clopidogrel plus aspirin compared to aspirin alone improves 90-day functional outcome ( absolute reduction of poor outcome 1.70 % , 95 % confidence interval 0.03 % -3.42 % ) .


Treatment for advanced-stage epithelial ovarian cancer ( AEOC ) includes primary debulking surgery ( PDS ) or neoadjuvant chemotherapy ( NACT ) .


A randomized controlled trial comparing these treatments resulted in comparable overall survival ( OS ) .


Studies report more complications and lower chemotherapy completion rates in patients 65 years old or older receiving PDS .


We sought to evaluate the cost implications of NACT relative to PDS in AEOC patients 65 years old or older .


A 5 year Markov model was created .


Arm 1 modeled PDS followed by 6 cycles of carboplatin and paclitaxel ( CT ) .


Arm 2 modeled 3 cycles of CT , followed by interval debulking surgery and then 3 additional cycles of CT. .


Parameters included OS , surgical complications , probability of treatment initiation , treatment cost , and quality of life ( QOL ) .


OS was assumed to be equal based on the findings of the international randomized control trial .


Differences in surgical complexity were accounted for in base surgical cost plus add-on procedure costs weighted by occurrence rates .


Hospital cost was a weighted average of diagnosis-related group costs weighted by composite estimates of complication rates .


Sensitivity analyses were performed .


Assuming equal survival , NACT produces a cost savings of $ 5616 .


If PDS improved median OS by 1.5 months or longer , PDS would be cost effective ( CE ) at a $ 100,000 / quality-adjusted life-year threshold .


If PDS improved OS by 3.2 months or longer , it would be CE at a $ 50,000 threshold .


The model was robust to variation in costs and complication rates .


Moderate decreases in the QOL with NACT would result in PDS being CE .


A model based on the RCT comparing NACT and PDS showed NACT is a cost-saving treatment compared with PDS for AEOC in patients 65 years old or older .


Small increases in OS with PDS or moderate declines in QOL with NACT would result in PDS being CE at the $ 100,000 / quality-adjusted life-year threshold .


Our results support further evaluation of the effects of PDS on OS , QOL and complications in AEOC patients 65 years old or older .


Aortic dissection is a lift-threatening medical emergency associated with high rates of morbidity and mortality .


The incidence rate of aortic dissection is estimated at 5 to 30 per 1 million people per year .


The prompt and correct diagnosis of aortic dissection is critical .


This study was to compare the ascending aortic image quality and the whole aortic radiation dose of high-pitch dual-source CT angiography and conventional dual-source CT angiography .


A total of 110 consecutive patients with suspected aortic dissection and other aortic disorders were randomly divided into two groups .


Group A underwent traditional scan mode and Group B underwent high-pitch dual-source CT scan mode .


The image quality and radiation dose of two groups were compared .


Close interobserver agreement was found for image quality scores ( = 0.87 ) .


The image quality of ascending aorta was significantly better in the high-pitch group than in the conventional group ( 2.78 0.46 vs 1.57 0.43 , P < 0.001 ) .


There was no significant difference of the CT attenuation values , the aortic image noise and SNR between two groups .


The mean radiation dose of high-pitch group was also significantly lower than that of conventional group ( 2.7 0.6 mSv vs. 3.9 0.9 mSv , P < 0.001 ) .


High-pitch dual-source CT angiography of the whole aorta can provide motion-artifact-free imaging of the ascending aorta at a low radiation dose compared to conventional protocol .


To evaluate ictal adipokine levels in episodic migraineurs and their association with pain severity and treatment response .


This was a double-blind , placebo-controlled trial evaluating peripheral blood specimens from episodic migraineurs at acute pain onset and 30 to 120 minutes after treatment with sumatriptan/naproxen sodium vs placebo .


Total adiponectin ( T-ADP ) , ADP multimers ( high molecular weight [ HMW ] , middle molecular weight , and low molecular weight [ LMW ] ) , leptin , and resistin levels were evaluated by immunoassays .


Thirty-four participants ( 17 responders , 17 nonresponders ) were included .


In all participants , pretreatment pain severity increased with every quartile increase in both the HMW : T-ADP ratio ( coefficient of variation [ CV ] 0.51 ; 95 % confidence interval [ CI ] : 0.08 , 0.93 ; p = 0.019 ) and resistin levels ( CV 0.58 ; 95 % CI : 0.21 , 0.96 ; p = 0.002 ) , but was not associated with quartile changes in leptin levels .


In responders , T-ADP ( CV -0.98 ; 95 % CI : -1.88 , -0.08 ; p = 0.031 ) and resistin ( CV -0.95 ; 95 % CI : -1.83 , -0.07 ; p = 0.034 ) levels decreased 120 minutes after treatment as compared with pretreatment .


In addition , in responders , the HMW : T-ADP ratio ( CV -0.04 ; 95 % CI : -0.07 , -0.01 ; p = 0.041 ) decreased and the LMW : T-ADP ratio ( CV 0.04 ; 95 % CI : 0.01 , 0.07 ; p = 0.043 ) increased at 120 minutes after treatment .


In nonresponders , the LMW : T-ADP ratio ( CV -0.04 ; 95 % CI : -0.07 , -0.01 ; p = 0.018 ) decreased 120 minutes after treatment .


Leptin was not associated with treatment response .


Both pretreatment migraine pain severity and treatment response are associated with changes in adipokine levels .


Adipokines represent potential novel migraine biomarkers and drug targets .


The benefit of novel implantable cardioverter defibrillator ( ICD ) programming in reducing inappropriate ICD therapy and mortality was demonstrated in Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy ( MADIT-RIT ) .


However , the cause of mortality reduction remains incompletely evaluated .


We aimed to identify factors associated with mortality , with focus on ICD therapy and programming in the MADIT-RIT population .


In MADIT-RIT , 1500 patients with a primary prophylactic indication for ICD or cardiac resynchronization therapy with defibrillator were randomized to 1 of 3 different ICD programming arms : conventional programming ( ventricular tachycardia zone 170 beats per minute ) , high-rate programming ( ventricular tachycardia zone 200 beats per minute ) , and delayed programming ( 60-second delay before therapy 170 beats per minute ) .


Multivariate Cox models were used to assess the influence of time-dependent appropriate and inappropriate ICD therapy ( shock and antitachycardia pacing ) and randomized programming arm on all-cause mortality .


During an average follow-up of 1.40.6 years , 71 of 1500 ( 5 % ) patients died : cardiac in 40 patients ( 56.3 % ) , noncardiac in 23 patients ( 32.4 % ) , and unknown in 8 patients ( 11.3 % ) .


Appropriate shocks ( hazard ratio , 6.32 ; 95 % confidence interval , 3.13-12 .75 ; P < 0.001 ) and inappropriate therapy ( hazard ratio , 2.61 ; 95 % confidence interval , 1.28-5 .31 ; P = 0.01 ) were significantly associated with an increased mortality risk .


There was no evidence of increased mortality risk in patients who experienced appropriate antitachycardia pacing only ( hazard ratio , 1.02 ; 95 % confidence interval , 0.36-2 .88 ; P = 0.98 ) .


Randomization to conventional programming was identified as an independent predictor of death when compared with patients randomized to high-rate programming ( hazard ratio , 2.0 ; 95 % confidence interval , 1.06-3 .71 ; P = 0.03 ) .


In MADIT-RIT , appropriate shocks , inappropriate ICD therapy , and randomization to conventional ICD programming were independently associated with an increased mortality risk .


Appropriate antitachycardia pacing was not related to an adverse outcome .


clinicaltrials.gov Unique identifier : NCT00947310 .


Depression is common in patients with chronic kidney disease who are on hemodialysis .


Available behavioral modalities for treating depression may not be feasible for patients who receive hemodialysis two or three times per week .


The purpose of this randomized controlled trial was to examine the efficacy of a nurse-led , in-center breathing training program in reducing depressive symptoms and improving sleep quality and health-related quality of life in patients on maintenance hemodialysis .


Fifty-seven patients on hemodialysis were randomly assigned either to an eight-session breathing training group or to a control group .


The Beck Depression Inventory II ( BDI-II ) , the Pittsburgh Sleep Quality Index ( PSQI ) , and the Medical Outcome Studies 36-Item Short Form Health Survey ( SF-36 ) were used to assess self-reported depressive symptoms , sleep quality , and health-related quality of life , respectively .


The intervention group exhibited significantly greater decreases in BDI-II scores than the control group .


No significant differences in PSQI change scores were observed between the groups .


SF-36 change scores for both the domain of role limitation due to emotional problems and the mental component summary were significantly higher in the breathing training group than in the control group .


This intervention significantly alleviated depressive symptoms , reduced perceived role limitation due to emotional problems , and improved the overall mental health component of quality of life in patients on maintenance hemodialysis .


WHO recommends hospital-based treatment for young infants aged 0-59 days with clinical signs of possible serious bacterial infection , but most families in resource-poor settings can not accept referral .


We aimed to assess whether use of simplified antibiotic regimens to treat young infants with clinical signs of severe infection was as efficacious as an injectable procaine benzylpenicillin-gentamicin combination for 7 days for situations in which hospital referral was not possible .


In a multisite open-label equivalence trial in DR Congo , Kenya , and Nigeria , community health workers visited all newborn babies at home , identifying and referring unwell young infants to a study nurse .


We stratified young infants with clinical signs of severe infection whose parents did not accept referral to hospital by age ( 0-6 days and 7-59 days ) , and randomly assigned each individual within these strata to receive one of the four treatment regimens .


Randomisation was stratified by age group of infants .


An age-stratified randomisation scheme with block size of eight was computer-generated off-site at WHO .


The outcome assessor was masked .


We randomly allocated infants to receive injectable procaine benzylpenicillin-gentamicin for 7 days ( group A , reference group ) ; injectable gentamicin and oral amoxicillin for 7 days ( group B ) ; injectable procaine benzylpenicillin-gentamicin for 2 days , then oral amoxicillin for 5 days ( group C ) ; or injectable gentamicin for 2 days and oral amoxicillin for 7 days ( group D ) .


Trained health professionals gave daily injections and the first dose of oral amoxicillin .


Our primary outcome was treatment failure by day 8 after enrolment , defined as clinical deterioration , development of a serious adverse event ( including death ) , no improvement by day 4 , or not cured by day 8 .


Independent outcome assessors , who did not know the infant 's treatment regimen , assessed study outcomes on days 4 , 8 , 11 , and 15 .


Primary analysis was per protocol .


We used a prespecified similarity margin of 5 % to assess equivalence between regimens .


This study is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN12610000286044 .


In Kenya and Nigeria , we started enrolment on April 4 , 2011 , and we enrolled the necessary number of young infants aged 7 days or older from Oct 17 , 2011 , to April 30 , 2012 .


At these sites , we continued to enrol infants younger than 7 days until March 29 , 2013 .


In DR Congo , we started enrolment on Sept 17 , 2012 , and continued until June 28 , 2013 .


We randomly assigned 3564 young infants to either group A ( n = 894 ) , group B ( n = 884 ) , group C ( n = 896 ) , or group D ( n = 890 ) .


We excluded 200 randomly assigned infants , who did not fulfil the predefined criteria of adherence to treatment and adequate follow-up .


In the per-protocol analysis , 828 infants were included in group A , 826 in group B , 862 in group C , and 848 in group D. 67 ( 8 % ) infants failed treatment in group A compared with 51 ( 6 % ) infants in group B ( risk difference -19 % , 95 % CI -44 to 01 ) , 65 ( 8 % ) in group C ( -06 % , -31 to 20 ) , and 46 ( 5 % ) in group D ( -27 % , -51 to 03 ) .


Treatment failure in groups B , C , and D was within the similarity margin compared with group A.


During the 15 days after random allocation , 12 ( 1 % ) infants died in group A , compared with ten ( 1 % ) infants in group B , 20 ( 2 % ) infants in group C , and 11 ( 1 % ) infants in group D.


An infant in group A had a serious adverse event other than death ( injection abscess ) .


The three simplified regimens were as effective as injectable procaine benzylpenicillin-gentamicin for 7 days on an outpatient basis in young infants with clinical signs of severe infection , without signs of critical illness , and whose caregivers did not accept referral for hospital admission .


Bill & Melinda Gates Foundation grant to WHO .


Suppression of ovarian estrogen production reduces the recurrence of hormone-receptor-positive early breast cancer in premenopausal women , but its value when added to tamoxifen is uncertain .


We randomly assigned 3066 premenopausal women , stratified according to prior receipt or nonreceipt of chemotherapy , to receive 5 years of tamoxifen , tamoxifen plus ovarian suppression , or exemestane plus ovarian suppression .


The primary analysis tested the hypothesis that tamoxifen plus ovarian suppression would improve disease-free survival , as compared with tamoxifen alone .


In the primary analysis , 46.7 % of the patients had not received chemotherapy previously , and 53.3 % had received chemotherapy and remained premenopausal .


After a median follow-up of 67 months , the estimated disease-free survival rate at 5 years was 86.6 % in the tamoxifen-ovarian suppression group and 84.7 % in the tamoxifen group ( hazard ratio for disease recurrence , second invasive cancer , or death , 0.83 ; 95 % confidence interval [ CI ] , 0.66 to 1.04 ; P = 0.10 ) .


Multivariable allowance for prognostic factors suggested a greater treatment effect with tamoxifen plus ovarian suppression than with tamoxifen alone ( hazard ratio , 0.78 ; 95 % CI , 0.62 to 0.98 ) .


Most recurrences occurred in patients who had received prior chemotherapy , among whom the rate of freedom from breast cancer at 5 years was 82.5 % in the tamoxifen-ovarian suppression group and 78.0 % in the tamoxifen group ( hazard ratio for recurrence , 0.78 ; 95 % CI , 0.60 to 1.02 ) .


At 5 years , the rate of freedom from breast cancer was 85.7 % in the exemestane-ovarian suppression group ( hazard ratio for recurrence vs. tamoxifen , 0.65 ; 95 % CI , 0.49 to 0.87 ) .


Adding ovarian suppression to tamoxifen did not provide a significant benefit in the overall study population .


However , for women who were at sufficient risk for recurrence to warrant adjuvant chemotherapy and who remained premenopausal , the addition of ovarian suppression improved disease outcomes .


Further improvement was seen with the use of exemestane plus ovarian suppression .


( Funded by Pfizer and others ; SOFT ClinicalTrials.gov number , NCT00066690 . )


A previous randomized controlled trial showed no clear superiority of vertical scar over inverted T-shaped reduction mammaplasty in terms of health-related quality of life .


No economic evaluation has been undertaken comparing vertical scar reduction and inverted T - shaped reduction .


A total of 255 patients were randomized to either vertical scar or inverted T - shaped reduction .


The effectiveness was measured with the Health Utilities Index Mark 3 .


Direct and productivity costs were captured parallel to the randomized controlled trial .


Perspectives of the Ministry of Health , patient , and society were considered .


Inverted T - shaped reduction dominated vertical scar reduction from the Ministry of Health perspective by being slightly less costly ( $ 3090.06 versus $ 3106.58 ) and slightly more effective ( 0.87 quality-adjusted life-years versus 0.86 quality-adjusted life-years ) .


From the societal and patient perspectives , vertical scar reduction was both less costly and less effective .


At the commonly quoted Canadian threshold of $ 50,000 per quality-adjusted life-year gained , the probability that vertical scar reduction was cost-effective was 29.3 , 68.2 , and 66.9 percent from the Ministry of Health , patient , and societal perspectives .


Subgroup analysis of reductions less than 500 g found that vertical scar reduction was more likely cost-effective .


Vertical scar reduction is more likely than not cost-effective from patient and societal perspectives but not from the Ministry of Health perspective at a willingness-to-pay threshold of $ 50,000 per quality-adjusted life-year .


If we limit vertical scar reduction for resections less than 500 g per breast , this technique is more likely cost-effective from all perspectives .


Resistance training ( RT ) improves muscle strength and overall physical function in older adults .


RT may be particularly important in the obese elderly who have compromised muscle function .


Whether caloric restriction ( CR ) acts synergistically with RT to enhance function is unknown .


As the primary goal of the Improving Muscle for Functional Independence Trial ( I 'M FIT ) , we determined the effects of adding CR for weight loss on muscle and physical function responses to RT in older overweight and obese adults .


I 'M FIT was a 5-mo trial in 126 older ( 65-79 y ) overweight and obese men and women who were randomly assigned to a progressive , 3-d/wk , moderate-intensity RT intervention with a weight-loss intervention ( RT+CR ) or without a weight-loss intervention ( RT ) .


The primary outcome was maximal knee extensor strength ; secondary outcomes were muscle power and quality , overall physical function , and total body and thigh compositions .


Body mass decreased in the RT+CR group but not in the RT group .


Fat mass , percentage of fat , and all thigh fat volumes decreased in both groups , but only the RT+CR group lost lean mass .


Adjusted postintervention body - and thigh-composition measures were all lower with RT+CR except intermuscular adipose tissue ( IMAT ) .


Knee strength , power , and quality and the 4-m gait speed increased similarly in both groups .


Adjusted postintervention means for a 400-m walk time and self-reported disability were better with RT+CR with no group differences in other functional measures , including knee strength .


Participants with a lower percentage of fat and IMAT at baseline exhibited a greater improvement in the 400-m walk and knee strength and power .


RT improved body composition ( including reducing IMAT ) and muscle strength and physical function in obese elderly , but those with higher initial adiposity experienced less improvement .


The addition of CR during RT improves mobility and does not compromise other functional adaptations to RT. .


These findings support the incorporation of RT into obesity treatments for this population regardless of whether CR is part of the treatment .


This trial was registered at clinicaltrials.gov as NCT01049698 .


To investigate the effect of two foot placements ( normal or posterior placement ) and three arm positions ( hands on the thighs , arms crossed over chest , and augmented arm position with elbow extended ) on the five times sit-to-stand ( FTSTS ) test times of individuals with chronic stroke .


Cross-sectional study .


Setting .


University-based rehabilitation clinic .


A convenience sample of community-dwelling individuals with chronic stroke ( N = 45 ) .


The times in completing the FTSTS with two foot placements and the three arm positions were recorded by stopwatch .


Posterior foot placement led to significantly shorter FTSTS times when compared with normal foot placement in all the 3 arm positions ( P 0.001 ) .


In addition , hands on thigh position led to significantly longer FTSTS times than the augmented arm position ( P = 0.014 ) .


Our results showed that foot placement and arm position could influence the FTSTS times of individuals with chronic stroke .


Standardizing the foot placement and arm position in the test procedure is essential , if FTSTS test is intended to be used repeatedly on the same subject .


It is unknown whether intentional weight loss provides long-term benefits for cognitive function .


An ancillary study to a randomized controlled clinical trial was conducted in overweight and obese individuals ( N = 978 ) , aged 45-76 years at enrollment , with type 2 diabetes .


An intensive behavioral intervention designed to promote and maintain weight loss through caloric restriction and increased physical activity was compared with diabetes support and education .


Standardized assessments of cognitive function were collected an average of 8.1 years after trial enrollment .


Participants assigned to intensive lifestyle intervention lost a mean ( SE ) 11.1 % ( 0.4 % ) and 7.2 % ( 0.5 % ) of weight at Years 1 and 8 , respectively , compared with 1.0 % ( 0.2 % ) and 3.3 % ( 0.5 % ) in the control group ( p < .001 ) .


Covariate-adjusted mean composite cognitive function test scores were similar for the two groups ( p = .69 ) , and no significant differences were found for any individual cognitive test .


There was some evidence of a differential effect ( nominal interaction p = .008 ) for a prespecified comparison : Intensive lifestyle intervention was associated with a relative mean benefit for composite cognitive function of 0.276 ( 95 % confidence interval : 0.033 , 0.520 ) SDs among individuals with body mass index less than 30 kg/m ( 2 ) at baseline compared with a relative mean deficit of 0.086 ( -0.021 , 0.194 ) SDs among individuals with body mass more than or equal to 30 kg/m ( 2 ) .


Eight years of intensive lifestyle intervention did not alter cognitive function in obese adults with type 2 diabetes ; however , there was evidence for benefit among overweight but not obese individuals .


Changes in cognition were not assessed in this cross-sectional study .


The occurrence of contrast induced acute kidney injury ( CIAKI ) has a pronounced impact on morbidity and mortality .


The aim of the present study was to appraise the diagnostic efficacy of age , estimated glomerular filtration rate ( eGFR ) and ejection fraction ( AGEF ) score ( age/EF ( % ) +1 ( if eGFR was < 60 ml min ( -1 ) 1.73 m ( -2 ) ) ) as an predictor of CIAKI in patients with diabetes mellitus ( DM ) and concomitant chronic kidney disease ( CKD ) .


The AGEF score was calculated for 2 998 patients with type 2 DM and concomitant CKD who had undergone coronary/peripheral arterial angiography .


CIAKI was defined as an increase in sCr concentration of 0.5 mg/dl ( 44.2 mmol/L ) or 25 % above baseline at 72 hours after exposure to the contrast medium .


Post hoc analysis was performed by stratifying the rate of CIAKI according to AGEF score tertiles .


The diagnostic efficacy of the AGEF score for predicting CIAKI was evaluated with receiver operating characteristic ( ROC ) analysis .


The AGEF score ranged from 0.49 to 3.09 .


The AGEF score tertiles were defined as follows : AGEFlow 0.92 ( n = 1 006 ) ; 0.92 < AGEFmid 1.16 ( n = 1 000 ) , and ACEFhigh > 1.16 ( n = 992 ) .


The incidence of CIAKI was significantly different in patients with low , middle and high AGEF scores ( AGEFlow = 1.1 % , AGEFmid = 2.3 % and AGEFhigh = 5.8 % , P < 0.001 ) .


By multivariate analysis , AGEF score was an independent predictor of CIAKI ( odds ratio = 4.96 , 95 % CI : 2.32-10 .58 , P < 0.01 ) .


ROC analysis showed that the area under the curve was 0.70 ( 95 % CI : 0.648-0 .753 , P < 0.001 ) .


The AGEF score is effective for stratifying risk of CIAKI in patients with DM and CKD undergoing coronary/peripheral arterial angiography .


( Clinical Trial identifier : NCT00786136 ) .


Low back pain ( LBP ) is common in primary care .


Guidelines recommend delaying referrals for physical therapy .


To evaluate whether early physical therapy ( manipulation and exercise ) is more effective than usual care in improving disability for patients with LBP fitting a decision rule .


Randomized clinical trial with 220 participants recruited between March 2011 and November 2013 .


Participants with no LBP treatment in the past 6 months , aged 18 through 60 years ( mean age , 37.4 years [ SD ,10.3 ] ) , an Oswestry Disability Index ( ODI ) score of 20 or higher , symptom duration less than 16 days , and no symptoms distal to the knee in the past 72 hours were enrolled following a primary care visit .


All participants received education .


Early physical therapy ( n = 108 ) consisted of 4 physical therapy sessions .


Usual care ( n = 112 ) involved no additional interventions during the first 4 weeks .


Primary outcome was change in the ODI score ( range : 0-100 ; higher scores indicate greater disability ; minimum clinically important difference , 6 points ) at 3 months .


Secondary outcomes included changes in the ODI score at 4-week and 1-year follow-up , and change in pain intensity , Pain Catastrophizing Scale ( PCS ) score , fear-avoidance beliefs , quality of life , patient-reported success , and health care utilization at 4-week , 3-month , and 1-year follow-up .


One-year follow-up was completed by 207 participants ( 94.1 % ) .


Using analysis of covariance , early physical therapy showed improvement relative to usual care in disability after 3 months ( mean ODI score : early physical therapy group , 41.3 [ 95 % CI , 38.7 to 44.0 ] at baseline to 6.6 [ 95 % CI , 4.7 to 8.5 ] at 3 months ; usual care group , 40.9 [ 95 % CI , 38.6 to 43.1 ] at baseline to 9.8 [ 95 % CI , 7.9 to 11.7 ] at 3 months ; between-group difference , -3.2 [ 95 % CI , -5.9 to -0.47 ] , P = .02 ) .


A significant difference was found between groups for the ODI score after 4 weeks ( between-group difference , -3.5 [ 95 % CI , -6.8 to -0.08 ] , P = .045 ] ) , but not at 1-year follow-up ( between-group difference , -2.0 [ 95 % CI , -5.0 to 1.0 ] , P = .19 ) .


There was no improvement in pain intensity at 4-week , 3-month , or 1-year follow-up ( between-group difference , -0.42 [ 95 % CI , -0.90 to 0.02 ] at 4-week follow-up ; -0.38 [ 95 % CI , -0.84 to 0.09 ] at 3-month follow-up ; and -0.17 [ 95 % CI , -0.62 to 0.27 ] at 1-year follow-up ) .


The PCS scores improved at 4 weeks and 3 months but not at 1-year follow-up ( between-group difference , -2.7 [ 95 % CI , -4.6 to -0.85 ] at 4-week follow-up ; -2.2 [ 95 % CI , -3.9 to -0.49 ] at 3-month follow-up ; and -0.92 [ 95 % CI , -2.7 to 0.61 ] at 1-year follow-up ) .


There were no differences in health care utilization at any point .


Among adults with recent-onset LBP , early physical therapy resulted in statistically significant improvement in disability , but the improvement was modest and did not achieve the minimum clinically important difference compared with usual care .


clinicaltrials.gov Identifier : NCT01726803 .


To compare the efficacy difference in treatment of myofasical pain syndrome between sparrow-pecking moxibustion and acupuncture at trigger points so as to provide the reference of the effective therapeutic method for myofascial pain syndrome .


Ninety patients were randomized into a sparrow-pecking moxibustion group and an acupuncture group , 45 cases in each one .


The trigger points were selected in pain areas in the two groups .


In the sparrow-pecking moxibustion group , the sparrow-pecking moxibustion was applied , 30 min in each time .


In the acupuncture group , the filiform needles were inserted obliquely at 45 degrees and retained for 40 min in each treatment .


The treatment was given once a day and 10 treatments made one session in the two groups .


The short-form McGill pain questionnaire was used as the observation index , and the changes in pain rating index ( PRI ) , present pain intensity ( PPI ) and visual analogue scale ( VAS ) before and after treatment were used for efficacy assessment .


The results of PRI , PPI and VAS after treatment were reduced apparently as compared with those before treatment in the sparrow-pecking moxibustion group and the acupuncture group ( all P < 0.001 ) .


The differences in PRI , PPI and VAS after treatment were not significant in comparison of the two groups ( both P > 0.05 ) .


The curative and remarkably effective rate was 80.0 % ( 36/45 ) in the sparrow-pecking moxibustion group , which was better than 40.0 % ( 18/45 , P < 0.001 ) in the acupuncture group .


Sparrow-pecking moxibustion at trigger points achieves the superior efficacy on myofascial pain syndrome as compared with acupuncture at trigger points .


This therapy is simpler in operation additionally .


Physical inactivity increases the risk of many chronic diseases including coronary heart disease , type 2 diabetes and some cancers .


It is recommended that adults should undertake at least 150 minutes of moderate intensity physical activity throughout the week but many adults do not achieve this .


An opportunity for working adults to accumulate the recommended activity levels is through the daily commute .


Employees will be recruited from workplaces in south-west England and south Wales .


In the intervention arm , workplace Walk-to-Work promoters will be recruited and trained .


Participating employees will receive Walk-to-Work materials and support will be provided through four contacts from the promoters over 10 weeks .


Workplaces in the control arm will continue with their usual practice .


The intervention will be evaluated by a cluster randomized controlled trial including economic and process evaluations .


The primary outcome is daily minutes of moderate to vigorous physical activity ( MVPA ) .


Secondary outcomes are : overall physical activity ; sedentary time ; modal shift away from private car use during the commute ; and physical activity/MVPA during the commute .


Accelerometers , GPS receivers and travel diaries will be used at baseline and one year follow-up .


Questionnaires will be used at baseline , immediately post intervention , and one year follow-up .


The process evaluation will examine the context , delivery and response to the intervention from the perspectives of employers , Walk-to-Work promoters and employees using questionnaires , descriptive statistics , fieldnotes and interviews .


A cost-consequence study will include employer , employee and health service costs and outcomes .


Time and consumables used in implementing the intervention will be measured .


Journey time , household commuting costs and expenses will be recorded using travel diaries to estimate costs to employees .


Presenteeism , absenteeism , employee wellbeing and health service use will be recorded .


Compared with other forms of physical activity , walking is a popular , familiar and convenient , and the main option for increasing physical activity in sedentary populations .


To our knowledge , this is the first full-scale randomised controlled trial to objectively measure ( using accelerometers and GPS receivers ) the effectiveness of a workplace intervention to promote walking during the commute to and from work .


ISRCTN15009100 ( 10 December 2014 ) .


UK guidelines recommend that patients with schizophrenia are offered access to social activities , however , the impact of such interventions have not been examined in a large randomized trial .


To investigate the effect of an activity group intervention on mental health and global functioning 12 months after randomization compared to standard care alone .


Secondary analysis of data from the MATISSE study .


Primary outcomes were global functioning , assessed using the Global Assessment of Functioning ( GAF ) , and mental health symptoms measured using the Positive and Negative Syndrome Scale ( PANSS ) .


About 140 participants were randomized to activity groups and 137 to standard care alone .


Follow-up data were collected from 242 ( 87 % ) participants .


Mental health improved significantly among those offered activity groups ( change in PANSS score = -6.0 , 95 % CI -2.3 to -9.8 ) but global functioning did not ( change in GAF score = 0.8 , 95 % CI -1.7 to 3.3 ) .


No significant differences were found between treatment arms .


Offering activity groups to patients with schizophrenia was not associated with any additional clinical benefits .


There was poor uptake and attendance at activity groups .


Interventions that aim to improve negative symptoms may be useful in enabling engagement in psychosocial interventions .


Hypothermia at 33.5 C for 72 hours for neonatal hypoxic ischemic encephalopathy reduces death or disability to 44 % to 55 % ; longer cooling and deeper cooling are neuroprotective in animal models .


To determine if longer duration cooling ( 120 hours ) , deeper cooling ( 32.0 C ) , or both are superior to cooling at 33.5 C for 72 hours in neonates who are full-term with moderate or severe hypoxic ischemic encephalopathy .


A randomized , 22 factorial design clinical trial performed in 18 US centers in the Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) Neonatal Research Network between October 2010 and November 2013 .


Neonates were assigned to 4 hypothermia groups ; 33.5 C for 72 hours , 32.0 C for 72 hours , 33.5 C for 120 hours , and 32.0 C for 120 hours .


The primary outcome of death or disability at 18 to 22 months is ongoing .


The independent data and safety monitoring committee paused the trial to evaluate safety ( cardiac arrhythmia , persistent acidosis , major vessel thrombosis and bleeding , and death in the neonatal intensive care unit [ NICU ] ) after the first 50 neonates were enrolled , then after every subsequent 25 neonates .


The trial was closed for emerging safety profile and futility analysis after the eighth review with 364 neonates enrolled ( of 726 planned ) .


This report focuses on safety and NICU deaths by marginal comparisons of 72 hours ' vs 120 hours ' duration and 33.5 C depth vs 32.0 C depth ( predefined secondary outcomes ) .


The NICU death rates were 7 of 95 neonates ( 7 % ) for the 33.5 C for 72 hours group , 13 of 90 neonates ( 14 % ) for the 32.0 C for 72 hours group , 15 of 96 neonates ( 16 % ) for the 33.5 C for 120 hours group , and 14 of 83 neonates ( 17 % ) for the 32.0 C for 120 hours group .


The adjusted risk ratio ( RR ) for NICU deaths for the 120 hours group vs 72 hours group was 1.37 ( 95 % CI , 0.92-2 .04 ) and for the 32.0 C group vs 33.5 C group was 1.24 ( 95 % CI , 0.69-2 .25 ) .


Safety outcomes were similar between the 120 hours group vs 72 hours group and the 32.0 C group vs 33.5 C group , except major bleeding occurred among 1 % in the 120 hours group vs 3 % in the 72 hours group ( RR , 0.25 [ 95 % CI , 0.07-0 .91 ] ) .


Futility analysis determined that the probability of detecting a statistically significant benefit for longer cooling , deeper cooling , or both for NICU death was less than 2 % .


Among neonates who were full-term with moderate or severe hypoxic ischemic encephalopathy , longer cooling , deeper cooling , or both compared with hypothermia at 33.5 C for 72 hours did not reduce NICU death .


These results have implications for patient care and design of future trials .


clinicaltrials.gov Identifier : NCT01192776 .


To evaluate the effectiveness and safety of leuprolide acetate in the treatment of endometriosis .


From Nov. 2007 to Oct. 2012 , the patients who confirmed to be endometriosis were randomly divided into test group of 113 cases and control group of 116 cases .


The test drug was the sustained-release agent of leuprolide acetate .


The control drug was Enantone .


The drugs were used for 3 times in total .


After treatment , the ovarian mass volumes measured with type-B ultrasound , the scores of the patient 's subjective symptoms during non-menstrual and menstruation days , the pelvic signs during non-menstrual days , the changes of hormones [ estradiol ( E2 ) , FSH , LH ] , and adverse events were observed .


After the treatment , the rate of changes of ovarian mass volume ( among them , at 12 weeks after the first injection , the median was -55.83 % in the test group , -68.22 % in the control group , P = 0.336 ) , the distinct improvement rate of symptom scores and pelvic signs during non-menstrual days [ among them , at 12 weeks after the first injection , the rate of lower abdomen pain was 47.5 % ( 48/101 ) in the test group , 44.0 % ( 44/100 ) in the control group , P = 0.881 ] , the hormone ( E2 , FSH , LH ) levels [ among them , at 12 weeks after the first injection , the serum level of E2 , was ( 3338 ) pmol/L in the test group , ( 3840 ) pmol/L in the control group , P = 0.414 ; the serum level of FSH , was ( 5.12.8 ) U/L in the test group , ( 5.32.3 ) U/L in the control group , P = 0.666 ; the serum level of LH , was ( 0.60.8 ) U/L in the test group , ( 0.60.9 ) U/L in the control group , P = 0.907 ] , had no statistically significant difference between the two groups ( all P > 0.05 ) .