The primary end point was percentage of days with guideline adherence during ICU treatment .


Secondary end points were antibiotic-free days and all-cause mortality compared for patients with low versus high guideline adherence .


Adherence to guidelines increased from 61 % prior to implementation to 92 % in post1 , decreased in post2 to 76 % and remained significantly higher compared with baseline in post3 , with 71 % ( p = 0.178 ) .


Additionally , antibiotic-free days increased over study periods .


At all time periods , mortality for patients with low guideline adherence was higher with 12.3 % versus 8 % ( p = 0.014 ) and an adjusted OR of 1.56 ( 95 % CI 1.05 to 2.31 ) .


Implementation of computerised regional adapted guidelines for antibiotic therapy is paralleled with improved adherence .


Even without further measures , adherence stayed high for a longer period and was paralleled by reduced antibiotic exposure .


Improved guideline adherence was associated with reduced ICU mortality .


ISRCTN54598675 .


Previous investigations in pancreatic cancer suggest a prognostic role for - smooth muscle actin ( - SMA ) expression and stromal density in the peritumoural stroma .


The aim of this study was to further validate the impact of - SMA expression and stromal density in resectable pancreatic cancer patients treated with adjuvant gemcitabine compared with untreated patients .


CONKO-001 was a prospective randomised phase III study investigating the role of adjuvant gemcitabine as compared with observation .


Tissue samples of 162 patients were available for immunohistochemistry on tissue microarrays to evaluate the impact of - SMA expression and stromal density impact on patient outcome .


High - SMA expression in tumour stroma was associated with worse patient outcome ( DFS : P = 0.05 , OS : P = 0.047 ) .


A dense stroma reaction was associated with improved disease-free survival ( DFS ) and overall survival ( OS ) in the overall study population ( DFS : P = 0.001 , OS : P = 0.001 ) .


This positive prognostic impact was restricted to patients with no adjuvant treatment ( DFS : P < 0.001 , OS : P < 0.001 ) .


In multivariable analysis , - SMA and stromal density expression were independently predictive factors for survival .


Our data confirm the negative prognostic impact of high - SMA expression in pancreatic cancer patients after curatively intended resection .


In contrast to former investigations , we found a positive prognostic impact for a dense stroma .


This significant influence was restricted to patients who received no adjuvant therapy .


The CRTH2 antagonist OC000459 has previously been demonstrated to reduce airway inflammation and improve lung function in moderate persistent asthma .


A study was conducted to determine the effect of lower once daily doses of OC000459 and to define the phenotype of subjects most responsive to treatment .


Adult subjects ( percentage of predicted forced expiratory volume in 1s ( FEV1 ) 60-85 % ) were randomized to OC000459 at three dose levels ( 25mg once daily , 200mg once daily or 100mg twice daily ) or placebo for 12weeks ( n = 117-125 per group , full analysis set ) .


The primary endpoint was the change from baseline in prebronchodilator FEV1 , and secondary endpoints included Asthma Control Questionnaire ( ACQ ) and Standardised Asthma Quality of Life Questionnaire [ AQLQ ( S ) ] , and incidence of exacerbations and respiratory tract infections .


OC459 caused a significant improvement in FEV1 compared with placebo at a dose of 25mg once daily ( P = 0.028 ) .


A similar increase was observed in the other dose groups , and the mean change in FEV1 in the pooled dose groups at endpoint was 95ml greater than placebo ( P = 0.024 ) .


In a post hoc analysis of atopic eosinophilic subjects with uncontrolled asthma , a mean increase in FEV1 of 220ml was observed compared with placebo ( P = 0.005 ) .


The mean increase in FEV1 was more marked in younger subjects in this group : for subjects aged 40years , there was a mean increase of 355ml compared with placebo ( P = 0.007 ) .


Improvements in ACQ and AQLQ ( S ) were observed in both the full analysis set and the atopic eosinophilic subgroup .


There was a lower incidence of exacerbations and respiratory infections in subjects treated with OC000459 .


There were no drug-related serious adverse events .


OC000459 is a safe and effective oral anti-inflammatory agent , which achieved clinically meaningful improvements in lung function and asthma control in allergic asthmatics with an eosinophil-dominant form of the disease .


A dose of 25mg given once daily was as effective as the higher doses studied .


Squamous cell carcinoma of the anus ( SCCA ) is highly sensitive to chemoradiation ( CRT ) which achieves good loco-regional control and preserves anal function .


However , some patients require permanent stoma formation either as a result of surgery on relapse , poor anal function or treatment-related symptoms .


Our aim was to determine patient , tumour and treatment-related colostomy rates following CRT and maintenance chemotherapy in the ACT II trial .


The ACT II trial recruited 940 patients comparing 5FU-based CRT using cisplatin ( CisP ) or mitomycin C ( MMC ) with or without additional maintenance chemotherapy .


We investigated the association between colostomy-free survival ( CFS ) and progression-free survival ( PFS ) with age , gender , T-stage , N-stage , treatment and baseline haemoglobin .


The median follow-up was 5.1 years ( n = 884 evaluable/940 ) ; tumour site canal ( 84 % ) , margin ( 14 % ) ; stage T1/T2 ( 52 % ) , T3/T4 ( 46 % ) ; N + ( 32 % ) , N0 ( 62 % ) .


Twenty out of 118 ( 17 % ) colostomies fashioned before CRT were reversed within 8 months .


One hundred and twelve patients had a post-treatment colostomy due to persistent disease ( 98 ) or morbidity ( 14 ) .


Fifty-two per cent ( 61/118 ) of all pre-treatment colostomies were never reversed .


The 5-year CFS rates were 68 % MMC/Maint , 70 % CisP/Maint , 68 % MMC/No-maint and 65 % CisP/No-maint .


CRT with CisP did not improve CFS when compared with MMC ( hazard ratio : 1.04 , 95 % confidence interval : 0.82-1 .31 , P = 0.74 ) .


The 5-year CFS rates were higher for T1/T2 ( 79 % ) than T3/T4 ( 54 % ) tumours and higher for node-negative ( 72 % ) than node-positive ( 60 % ) patients .


Significant predictors of CFS were gender , T-stage and haemoglobin , while treatment factors had no impact on outcome .


Similar associations were found between PFS and tumour/treatment-related factors .


The majority ( 52 % ) of pre-treatment colostomies were never reversed .


Neither CRT with 5FU/CisP nor maintenance chemotherapy impacted on CFS .


The low risk of colostomy for late effects ( 1.7 % ) is likely to be associated with the modest total radiotherapy dose .


The predictive factors for CFS were T-stage , gender and baseline haemoglobin .


ISRCTN 26715889 .


Prior studies have suggested that low baseline quality-of-life ( QOL ) scores predict worse survival in patients undergoing lung cancer surgery .


However , these studies involved average-risk patients undergoing lobectomy .


We report QOL results from a multicenter trial , American College of Surgeons Oncology Group Z4032 , which randomized high-risk operable patients to sublobar resection ( SR ) , or SR with brachytherapy , and included longitudinal QOL assessments .


Global QOL , using the 36-item Short-Form Health Survey ( SF36 ) , and the dyspnea score from the University of California , San Diego Shortness of Breath Questionnaire ( SOBQ ) scale , was measured at baseline , 3 , 12 , and 24 months .


SF36 physical component summary ( PCS ) and mental component summary ( MCS ) scores were standardized and adjusted for age and gender normals , with scores < 50 indicating below-average health status .


SOBQ scores were transformed to a 0-100 ( poor-excellent ) scale .


Aims were to : ( 1 ) determine the impact of baseline scores on recurrence-free survival , overall survival , and 30-day adverse events ( AEs ) ; and ( 2 ) identify subgroups ( surgical approach , resection type .


tumor location , tumor size , respiratory function ) with a 10-point decline or improvement in QOL after SR. .


Two hundred twelve eligible patients were included .


There were no significant differences in baseline QOL scores between arms .


Median baseline PCS , MCS , and SOBQ scores were 42.7 , 51.1 , and 70.8 , respectively .


There were no differences in grade-3 + AEs , overall survival , or recurrence-free survival in patients with baseline scores median versus > median values , except for a significantly worse overall survival for patients with baseline SOBQ scores median value .


There were no significant differences between the study arms in percentage change of QOL scores from baseline to 3 , 12 , or 24 months .


Further comparison combining the 2 arms demonstrated a higher percentage of patients with a 10-point decline in SOBQ scores with segmentectomy compared with wedge resection ( 40.5 % vs 21.9 % , P = .03 ) at 12 months , with thoracotomy versus video-assisted thoracic surgery ( VATS ) ( 38.8 % vs 20.4 % , P = .03 ) at 12 months , and T1b versus T1a tumors ( 46.9 % vs 23.5 % , P = .020 ) at 24 months .


A 10-point improvement in PCS score was seen at 3 months with VATS versus thoracotomy ( 16.5 % vs 3.6 % , P = .02 ) .


In high-risk operable patients , poor baseline QOL scores were not predictive for worse overall or recurrence-free survival , or for higher risk for AEs following SR. .


VATS was associated with improvement in physical function at 3 months , and improved dyspnea scores at 12 months , lending support for the preferential use of VATS when SR is undertaken .


The purpose of this study was to develop a new Internet-based computerized cognitive behavior therapy ( iCBT ) program in Manga format , the Japanese cartoon , for workers and to examine the effects of the iCBT program on improving subthreshold depression using a randomized controlled trial ( RCT ) design among workers employed in private companies in Japan .


All workers in a company ( n = 290 ) and all workers in three departments ( n = 1,500 ) at the headquarters of another large company were recruited by an invitation e-mail .


Participants who fulfilled the inclusion criteria were randomly allocated to intervention or control groups ( N = 381 for each group ) .


A six-week , six-lesson iCBT program using Manga ( Japanese comic ) story was developed .


The program included several CBT skills : self-monitoring , cognitive restructuring , assertiveness , problem solving , and relaxation .


The intervention group studied the iCBT program at a frequency of one lesson per week .


Depression ( Beck Depression Inventory II ; BDI-II ) was assessed as a primary outcome at baseline , and three - and six-month follow-ups for both intervention and control groups were performed .


The iCBT program showed a significant intervention effect on BDI-II ( t = -1.99 , p < 0.05 ) with small effect sizes ( Cohen 's d : -0.16 , 95 % Confidence Interval : -0.32 to 0.00 , at six-month follow-up ) .


The present study first demonstrated that a computerized cognitive behavior therapy delivered via the Internet was effective in improving depression in the general working population .


It seems critical to improve program involvement of participants in order to enhance the effect size of an iCBT program .


UMIN Clinical Trials Registry UMIN000006210 .


Nutritional support is crucial to the management of patients receiving invasive mechanical ventilation ( IMV ) and the most commonly prescribed treatment in intensive care units ( ICUs ) .


International guidelines consistently indicate that enteral nutrition ( EN ) should be preferred over parenteral nutrition ( PN ) whenever possible and started as early as possible .


However , no adequately designed study has evaluated whether a specific nutritional modality is associated with decreased mortality .


The primary goal of this trial is to assess the hypothesis that early first-line EN , as compared to early first-line PN , decreases day 28 all-cause mortality in patients receiving IMV and vasoactive drugs for shock .


The NUTRIREA-2 study is a multicenter , open-label , parallel-group , randomized controlled trial comparing early PN versus early EN in critically ill patients requiring IMV for an expected duration of at least 48hours , combined with vasoactive drugs , for shock .


Patients will be allocated at random to first-line PN for at least 72hours or to first-line EN .


In both groups , nutritional support will be started within 24hours after IMV initiation .


Calorie targets will be 20 to 25kcal/kg/day during the first week , then 25 to 30kcal/kg/day thereafter .


Patients receiving PN may be switched to EN after at least 72hours in the event of shock resolution ( no vasoactive drugs for 24 consecutive hours and arterial lactic acid level below 2mmol/L ) .


On day 7 , all patients receiving PN and having no contraindications to EN will be switched to EN .


In both groups , supplemental PN may be added to EN after day 7 in patients with persistent intolerance to EN and inadequate calorie intake .


We plan to recruit 2,854 patients at 44 participating ICUs .


The NUTRIREA-2 study is the first large randomized controlled trial designed to assess the hypothesis that early EN improves survival compared to early PN in ICU patients .


Enrollment started on 22 March 2013 and is expected to end in November 2015 .


ClinicalTrials.gov Identifier : NCT01802099 ( registered 27 February 2013 ) .


Potassium-titanyl-phosphate ( KTP ) laser photocoagulation is commonly used for treatment of hereditary hemorrhagic telangiectasia-related epistaxis ( HHT-RE ) .


Electrosurgical plasma coagulation ( EPC ) , also known as coblation , has not been rigorously evaluated for HHT-RE .


Patients seeking treatment for HHT-RE between September 2010 and September 2012 were prospectively randomized ( 1:1 ) to KTP or EPC in a single blind prospective cohort study .


Length of surgery and estimated blood loss ( EBL ) were recorded .


Epistaxis severity scores ( ESSs ) and 10-cm visual analogue scale ( VAS ) scores for HHT-RE-related symptoms were administered at enrollment and at 3 , 6 , 12 months following surgery .


Statistical analysis used Friedman 's and Pearson 's chi-square tests .


Eleven HHT patients were prospectively enrolled and followed .


Six patients underwent EPC treatment while 5 underwent KTP .


Three patients in the KTP subgroup and 2 patients in the EPC subgroup requested additional surgical treatment within 12 months ( p > 0.999 ) .


There were no significant differences in terms of EBL ( p = 0.126 ) and length of surgery ( p = 0.429 ) between treatment groups .


Mean ESSs were not significantly different between groups at any follow-up point ( KTP , p = 0.896 ; EPC , p = 0.159 ) .


Compared to KTP , mean ESSs were higher in the EPC subgroup at baseline and lower at all other time points .


Mean nasal obstruction VAS scores were significantly lower in the EPC subgroup at all follow-up points .


EPC is a viable alternative to KTP laser photocoagulation for epistaxis control in patients with HHT .


Subjectively , patients experience less nasal obstruction following EPC as compared to KTP treatment .


A multicentered , well-powered study is warranted to better determine treatment outcomes .


Xuezhikang ( XZK ) is an extract of fermented red yeast rice that has lipid-lowering properties .


To evaluate the effects of XZK on lipids in subjects with dyslipidemia but no coronary heart disease .


A total of 116 adults with baseline non-high-density lipoprotein cholesterol ( non-HDL-C ) levels of approximately 208mg/dL and low-density lipoprotein cholesterol ( LDL-C ) levels of approximately 175mg/dL were randomized to either placebo or XZK 1200 or 2400mg daily and treated for 12weeks .


A majority of the patients were white ( 53.4 % ) or Asian ( 37.1 % ) .


Daily XZK 1200mg and 2400mg for 4 to 12weeks resulted in statistically significant ( P < .001 ) and clinically meaningful decreases in non-HDL-C ( 24 % reduction ) and LDL-C ( 27 % reduction ) compared with placebo .


XZK treatment at either dose enabled approximately 50 % of subjects to reduce their LDL-C levels by30 % .


Doubling the XZK daily dose from 1200 to 2400mg at treatment week 8 caused an additional 4.6 % reduction in LDL-C .


Significant benefits were also observed across secondary efficacy variables , including total cholesterol ( TC ) , apolipoprotein B ( Apo B ) , triglycerides , HDL-C , the TC/HDL-C ratio , and the Apo B/Apo A-I ratio , at treatment week 8 or 12 .


XZK was safe and well tolerated .


Safety and tolerability profiles were similar across treatment groups .


Most adverse events were gastrointestinal .


No subject experienced myopathy or markedly elevated liver transaminases or creatine kinase .


Xuezhikang significantly reduced non-HDL-C and LDL-C , and was well tolerated .


Further , longer-term studies in more diverse patient populations are needed to corroborate these findings .


No prior study has compared the efficacy of bifrontal ( BF ) vs right unilateral ( RUL ) electroconvulsive therapy ( ECT ) by including the subgroup that is most likely to receive it : only elderly patients with major depression ( MD ) .


This single-site , randomized , assessor-blinded , controlled trial was conducted from 2009 to 2013 .


Seventy-three elderly patients with MD , unipolar and bipolar , were treated with a course of formula-based BF ECT or RUL ECT .


The 17-item Hamilton Rating Scale for Depression ( HRSD17 ) was used to measure efficacy .


Safety was assessed with the Mini Mental State Examination ( MMSE ) .


Both electrode placements resulted in highly significant downward trends in symptom severity ( all p < 0.001 ) , with a non-significant difference between methods ( p = 0.703 ) .


At the end of the ECT course , response rates for the BF and RUL group were 63.9 % and 67.6 % , respectively .


Short-term remission , defined as an HRSD17 score7 , was achieved in 14 ( 38.9 % ) patients in the BF group and 19 ( 51.4 % ) patients in the RUL group .


Global cognitive function , as measured by the MMSE , did not deteriorate in the two treatment groups .


The small number of subjects may have led to reduced power to detect real differences .


The MMSE is not sufficient to ascertain the negative effect of ECT on cognition .


This study indicates that formula-based BF and RUL ECT are equally efficacious , and that remission rates of formula-based dosing are lower than those previously reported for titrated dosing , in a clinical sample of elderly patients with MD. .


ClinicalTrials.gov NCT01559324 .


Aging induces a shift in circulating hormones in women , accompanied by weight gain during the late reproductive , menopausal transition , and postmenopausal years .


Exercise has been shown to counter weight gain ; however , it might increase circulating androgens .


A 6-month aerobic and resistance training exercise regimen was implemented to examine interrelationships between circulating sex hormones , body composition , aerobic capacity , insulin sensitivity , and insulin resistance .


Twenty-eight women , aged 42 to 52 years , completed the 6-month intervention study .


They were randomly assigned to either a control ( CON ; n = 10 ) group-and maintained their sedentary lifestyle-or an exercise intervention ( EXE ; n = 18 ) group .


The exercise intervention consisted of combined aerobic and resistance workouts scheduled 6 days/week for 60 minutes/day .


Body weight , composition , VO2 peak , plasma insulin , glucose , lipid profile , estradiol , testosterone , progesterone , dehydroepiandrosterone , and dehydroepiandrosterone sulfate ( DHEAS ) were measured at baseline and on month 6 .


Insulin sensitivity was estimated using the insulin sensitivity index and the quantitative insulin sensitivity check index , whereas insulin resistance was estimated using the homeostatic model for insulin resistance .


There was a trend toward increased DHEAS in both groups ( P < 0.1 ) , but not as a function of the intervention .


Insulin sensitivity index increased in the EXE group compared with the CON group ( P < 0.01 ) .


Multiple linear regression indicated that , at 6 months , DHEAS was a negative contributor to insulin sensitivity in the EXE group , but not in the CON group .


In midlife women , an increase in circulating DHEAS , such as that previously reported during the menopausal transition , is associated with higher insulin resistance , but exercise can mitigate this risk by improving insulin sensitivity , thereby countering the effects of DHEAS .


To evaluate the effect of child obesity intervention comprehensive program on the improvement of overweight , obese control and knowledge-attitude-practice .


The study design was under cluster-randomized controlled trial , with 965 children in the intervention and 895 children in the control groups .


Repeated measurement data on child obesity was analyzed through Generalized Estimating Equation models .


The risk of becoming overweight or obesity in the intervention group was 0.824 times more than children in the control group , showing a reduction of 17.6 % the risk of being overweight or obese ( P = 0.031 ) .


In addition , the possibility of increasing one unit of correct rate on obesity related knowledge , children in the intervention group children was 1.044 times ( P = 0.001 ) than in the control group .


On the mean obesity related correct attitude rate , it was 1.023 times ( P = 0.001 ) in the intervention group of the control group .


Regarding the possibility of increasing one unit om the mean obesity related behavior score , children in the intervention group was 1.522 times ( P = 0.001 ) than those in the control group ( P = 0.046 ) .


The comprehensive child obesity intervention program could effectively reduce the risk of developing overweight or obesity and improving the obesity related knowledge , attitude and behavior in children .


This study aimed to determine whether the Physical Activity and Lymphedema ( PAL ) trial weight training program for breast cancer survivors at risk of or with breast cancer-related lymphedema provided skeletal benefits .


Of the 295 participants in the randomized controlled PAL trial , 258 ( weight training ; N = 128 ; control , N = 130 ) had complete measures of bone mineral density ( BMD ( in grams per square centimeter ) ) of the proximal femur and lumbar spine and were also categorized by T scores .


Women in the weight training group performed slowly progressive weight training 2 days/week for 12 months compared to women in the control group who maintained their usual physical activities .


There were no significant differences in the rate of BMD change at any skeletal site between weight training and control groups , regardless of menopausal status .


Distribution of bone health categories was not significantly different between groups at baseline , but became different at 12 months ( p < 0.03 ) among postmenopausal women due to an increase in the percentage of controls who became osteopenic ( 35 to 44 % ) compared to stable bone health in weight lifters .


The PAL weight training program that increased muscle strength without exacerbating or causing lymphedema among breast cancer survivors was not as efficacious at improving skeletal health .


The skeletal loads produced from the PAL program may be insufficient to notably shift BMD , but may have a subtle osteogenic effect .


The safety and efficacy of rigorous weight training programs for improving skeletal health in women at risk for or with breast cancer-related lymphedema remain to be determined .


Patients suffering from chronic kidney disease are at greater risk of developing infection than the normal population , and infections are the second cause of mortality after cardiovascular complications in this population .


Some reports suggest that the intake of active vitamin D might be beneficial to prevent infections .


Therefore , we aimed to determine if the oral intake of vitamin D receptor activator ( VDRA ) is associated with a lower risk of infection-related hospitalization ( IRH ) among incident chronic hemodialysis patients .


We conducted a nested case-control study in a cohort of 4933 patients initiating chronic hemodialysis between 1 January 2001 and 31 December 2007 in Quebec , Canada , using administrative databases .


We identified cases of hospital admission indicating an infection as main diagnosis on the hospital 's discharge sheet .


Up to 10 controls were randomly selected for each case .


Association between oral VDRA use and risk of IRH was estimated using conditional logistic regression .


We identified 1136 cases of IRH and 10396 controls during the study period .


The intake of VDRA was not associated with the risk of being hospitalized due to an infection ( odds ratio [ OR ] , 1.07 ; 95 % confidence interval [ CI ] , 0.95-1 .20 ) .


Using the prior 6-month cumulative dose of VDRA , we also found that a cumulative VDRA dose of less than 45 mcg ( OR , 1.05 ; 95 % CI , 0.92-1 .19 ) or greater than 45 mcg ( OR , 1.15 ; 95 % CI , 0.96-1 .36 ) was not associated with the IRH risk .


The oral intake of VDRA was not associated with the risk of IRH in incident hemodialysis patients .


We assessed differences in treatment between the screening and control arms of ERSPC Rotterdam and studied whether possible treatment differences could explain the positive study outcome .


In ERSPC Rotterdam men 55 to 74 years old were randomized to a screening arm of 21,210 and a control arm of 21,166 .


Treatment after diagnosis was at the discretion of the care provider chosen by the patient .


Initial treatment was compared in 4 risk groups .


The relation between prostate cancer incidence and prostate cancer mortality was assessed by risk group by correlating the incidence RR and the mortality RR .


A direct relation would have supported a stage shift as the main cause of changes in prostate cancer mortality .


Initial treatment differed between the arms in the low , intermediate and high risk groups but not in the metastatic group .


The RRs of prostate cancer incidence and mortality per risk group were related 1:1 ( regression line slope 1.00 , 95 % CI 0.30-1 .74 ) .


Of changes in prostate cancer mortality 94 % could be explained by changes in prostate cancer incidence .


This made treatment differences unlikely as the reason for the observed decrease in prostate cancer mortality .


Differences in treatment between the ERSPC Rotterdam screening and control arms were unlikely to explain the differences in prostate cancer mortality .


Results are instead consistent with a decrease in prostate cancer mortality as the result of a favorable stage through screening .


Dalbavancin , a lipoglycopeptide antibiotic agent that is active against gram-positive pathogens , has a long plasma half-life , allowing for once-weekly dosing .


DISCOVER 1 and DISCOVER 2 were identically designed noninferiority trials of dalbavancin for the treatment of acute bacterial skin and skin-structure infection .


We randomly assigned patients to receive dalbavancin intravenously on days 1 and 8 or vancomycin intravenously for at least 3 days with the option to switch to oral linezolid to complete 10 to 14 days of therapy .


The primary end point , early clinical response , required the cessation of spread of infection-related erythema and the absence of fever at 48 to 72 hours .


Secondary end points at the end of therapy included clinical status and investigator 's assessment of outcome .


Analysis of the primary end point showed noninferiority of dalbavancin in both DISCOVER 1 and DISCOVER 2 .


In the pooled analysis , 525 of 659 patients ( 79.7 % ) in the dalbavancin group and 521 of 653 ( 79.8 % ) in the vancomycin-linezolid group had an early clinical response indicating treatment success ( weighted difference , -0.1 percentage point ; 95 % confidence interval , -4.5 to 4.2 ) .


The outcomes were similar in the analyses by study and the pooled analyses of clinical status at the end of therapy and the investigator 's assessment of outcome .


For patients infected with Staphylococcus aureus , including methicillin-resistant S. aureus , clinical success was seen in 90.6 % of the patients treated with dalbavancin and 93.8 % of those treated with vancomycin-linezolid .


Adverse events and study days with an adverse event were less frequent in the dalbavancin group than in the vancomycin-linezolid group .


The most common treatment-related adverse events in either group were nausea , diarrhea , and pruritus .


Once-weekly intravenous dalbavancin was not inferior to twice-daily intravenous vancomycin followed by oral linezolid for the treatment of acute bacterial skin and skin-structure infection .


( Funded by Durata Therapeutics ; DISCOVER 1 and DISCOVER 2 ClinicalTrials.gov numbers , NCT01339091 and NCT01431339 . )


The primary aim of this study was to evaluate the long-term safety/tolerability of atomoxetine in Japanese adults with attention deficit hyperactivity disorder ( ADHD ) .


This 48-week , open-label extension study involved participants with ADHD who completed a 10-week randomized controlled trial of atomoxetine .


Participants received atomoxetine 40mg/day , followed by step-wise titration to a maximum of 120mg/day .


The primary outcome was safety/tolerability .


Secondary outcomes were symptoms of ADHD ( Conners ' Adult ADHD Rating Scales-Investigator Rated : Screening Version 18-item total score ) , quality of life ( Adult Attention-Deficit/Hyperactivity Disorder Quality of Life scale ) , and executive function ( Behavior Rating Inventory of Executive Function-Adult Version : Self-report ) .


Of the 39.5 % of participants overall who discontinued the study , 15.9 % ( 37/233 ) of participants discontinued because of adverse events ( AEs ) , primarily nausea ( 4.3 % ; 10/233 ) .


Overall , 93.6 % ( 218/233 ) of participants experienced treatment-emergent AEs ( TEAEs ) , most commonly nausea ( 56.2 % ; 131/233 ) , nasopharyngitis ( 25.3 % ; 59/233 ) , thirst ( 19.3 % ; 45/233 ) , headache ( 17.2 % ; 40/233 ) , and decreased appetite ( 16.3 % ; 38/233 ) .


Most TEAEs ( 70.8 % ; 165/233 ) were mild in intensity .


Overall , 79.8 % ( 186/233 ) of participants experienced 1 adverse drug reaction , primarily nausea ( 55.4 % ; 129/233 ) .


Five participants experienced serious AEs during the open-label extension ; none was related/possibly related to treatment .


There were statistically significant increases in vital signs and decreases in body weight that were not considered clinically significant .


Symptoms of ADHD , quality of life , and executive function were significantly improved from baseline to endpoint ( P < 0.05 ) .


Despite discontinuations due to the long-term , open-label design , AE related discontinuations were modest , suggesting that atomoxetine has acceptable long-term safety and tolerability in Japanese adults with ADHD .


Symptoms of ADHD improved and remained improved throughout the study .


To compare the efficacy and safety between low-fluence photodynamic therapy ( PDT ) and the intravitreal ranibizumab in the treatment of chronic central serous chorioretinopathy ( CSC ) .


Prospective , randomized , single-center , parallel-arm , controlled trial .


Thirty-four eyes of 32 patients with chronic CSC with > 6 months ' duration of symptoms or recurrent CSC were randomly placed into the low-fluence PDT group ( n = 18 ) or the ranibizumab group ( n = 16 ) .


The patients underwent a single session of low-fluence PDT or 3 consecutive monthly injections of ranibizumab .


Rescue treatment was available from month 3 if the subretinal fluid ( SRF ) persisted or recurred after primary treatment ; low-fluence PDT was given to the ranibizumab group and intravitreal ranibizumab to the low-fluence PDT group .


The primary outcome was the proportion of eyes with complete resolution of SRF without rescue treatment .


Secondary outcomes included the mean changes in logarithm of the minimum angle of resolution best-corrected visual acuity ( BCVA ) , central retinal thickness ( CRT ) , and angiographic findings from baseline to 12 months .


At month 12 , 16 eyes ( 88.9 % ) of the low-fluence PDT group maintained complete resolution of SRF without rescue treatment versus 2 eyes ( 12.5 % ) in the ranibizumab group ( P < 0.001 ) .


Two eyes ( 11.1 % ) in the low-fluence PDT group and 11 eyes ( 68.8 % ) in the ranibizumab group met the criteria for rescue treatment ( P = 0.001 ) .


In the low-fluence PDT group , the mean decrease in CRT from baseline was significantly greater than that in the ranibizumab group until month 6 ( P < 0.05 ) , but the differences became insignificant thereafter .


The improvement in BCVA from baseline was superior in the low-fluence PDT group to that in the ranibizumab group , but the differences were not statistically significant except at month 3 ( P = 0.025 ) .


On indocyanine green angiography , a significantly greater proportion of the low-fluence PDT group ( 16 eyes ; 88.9 % ) showed a marked reduction in choroidal hyperpermeability after primary treatment than that of the ranibizumab group ( 0 eyes ; P < 0.001 ) .


No serious adverse events related to the drugs or procedures were observed .


This study represents the overall superiority of low-fluence PDT compared with intravitreal ranibizumab in the treatment of chronic CSC .


Drinking water induces short-term cardiovascular and metabolic changes .


These effects are considered to be triggered by gastric distension and osmotic factors , but little is known about the influence of water temperature .


We determined , in a randomized crossover study , the acute cardiovascular and metabolic responses to 500 mL of tap water at 3 C ( cold ) , 22 C ( room ) and 37 C ( body ) in 12 young humans to ascertain an effect of water temperature .


We measured continuous beat-to-beat haemodynamics , skin blood flux with laser-Doppler flowmetry and resting energy expenditure by indirect calorimetry starting with a 30-min baseline followed by a 4-min drink period and a subsequent 90-min post-drink observation .


Ingestion of cold - and room-tempered water led to decreased heart rate ( P < 0.01 ) and double product ( P < 0.01 ) , and increased stroke volume ( P < 0.05 ) ; these effects were not observed with body-tempered water .


Drinking cold - and room - , but not body-tempered water , led to increased high frequency power of heart rate variability ( P < 0.05 ) and baroreflex sensitivity ( P < 0.05 ) .


Cold - and room-tempered water increased energy expenditure over 90 min by 2.9 % ( P < 0.05 ) and 2.3 % ( ns ) , respectively , accompanied by a diminished skin blood flux ( P < 0.01 ) , thereby suggesting that both small increases in heat production together with decreased heat loss contribute to warming up the ingested water to intra-abdominal temperature levels .


Overall , ingestion of cold - and room - , but not body-tempered water reduced the workload to the heart through a reduction in heart rate and double product which could be mediated by an augmented cardiac vagal tone .


Post-term pregnancy , a pregnancy exceeding 294 days or 42 completed weeks , is associated with increased perinatal morbidity and mortality and is considered a high-risk condition which requires specialist surveillance and induction of labour .


However , there is uncertainty on the policy concerning the timing of induction for post-term pregnancy or impending post-term pregnancy , leading to practice variation between caregivers .


Previous studies on induction at or beyond 41 weeks versus expectant management showed different results on perinatal outcome though conclusions in meta-analyses show a preference for induction at 41 weeks .


However , interpretation of the results is hampered by the limited sample size of most trials and the heterogeneity in design .


Most control groups had a policy of awaiting spontaneous onset of labour that went far beyond 42 weeks , which does not reflect usual care in The Netherlands where induction of labour at 42 weeks is the regular policy .


Thus leaving the question unanswered if induction at 41 weeks results in better perinatal outcomes than expectant management until 42 weeks .


In this study we compare a policy of labour induction at 41 + 0 / +1 weeks with a policy of expectant management until 42 weeks in obstetrical low risk women without contra-indications for expectant management until 42 weeks and a singleton pregnancy in cephalic position .


We will perform a multicenter randomised controlled clinical trial .


Our primary outcome will be a composite outcome of perinatal mortality and neonatal morbidity .


Secondary outcomes will be maternal outcomes as mode of delivery ( operative vaginal delivery and Caesarean section ) , need for analgesia and postpartum haemorrhage ( 1000 ml ) .


Maternal preferences , satisfaction , wellbeing , pain and anxiety will be assessed alongside the trial .


This study will provide evidence for the management of pregnant women reaching a gestational age of 41 weeks .


Dutch Trial Register ( Nederlands Trial Register ) : NTR3431 .


Registered : 14 May 2012 .


The objective of this study was to evaluate citalopram for executive functioning in Huntington 's disease ( HD ) .


The study was randomized , double-blind , and placebo-controlled .


Thirty-three adults with HD , cognitive complaints , and no depression ( Hamilton Depression [ HAM-D ] rating scale 12 ) were administered citalopram 20 mg or placebo ( 7 visits , 20 weeks ) , with practice and placebo run-ins .


The primary outcome was change in executive functioning .


The intent to treat analysis was controlled for practice effects , comparing visits 1 and 2 to visits 5 and 6 for citalopram versus placebo .


There were no significant benefits on the executive function composite ( treatment-placebo mean difference -0.167 ; 95 % confidence interval [ CI ] , -0.361 to 0.028 ; P = .092 ) .


Citalopram participants showed improved clinician-rated depression symptoms on the HAM-D ( t = -2.02 ; P = 0.05 ) .


There were no group differences on motor ratings , self-reported executive functions , psychiatric symptoms , or functional status .


There was no evidence that short-term treatment with citalopram improved executive functions in HD .


Despite excluding patients with active depression , participants on citalopram showed improved mood , raising the possibility of efficacy for subsyndromal depression in HD .


ACTG A5202 randomized treatment-nave individuals to tenofovir-emtricitabine ( TDF/FTC ) or abacavir-lamivudine ( ABC/3TC ) combined with efavirenz ( EFV ) or atazanavir/ritonavir ( ATV/r ) .


Individuals in the high screening viral load ( VL ) stratum ( 100,000 copies/mL ) had increased rates of virologic failure with ABC/3TC .


To compare regimen-specific early virologic response .


Using Wilcoxon rank-sum tests , we compared regimen-specific VL changes from entry to week 4 in A5202 subjects ( N = 1,813 ) and from entry to week 1 , 2 , and 4 in substudy subjects ( n = 179 ) .


We evaluated associations between week 4 VL change and time to virologic failure with Cox proportional hazards models .


TDF/FTC and ABC/3TC produced similar week 4 VL declines in the entire study population and in the high VL stratum .


EFV produced greater VL declines from baseline at week 4 than ATV/r ( median -2.1 vs -1.9 log10 copies/mL ; P < .001 ) .


In the substudy of subjects with week 1 , 2 , and 4 VL data , there was no difference in VL decline in individuals randomized to TDF/FTC versus ABC/3TC , but EFV resulted in greater VL decline from entry at each of these timepoints than ATV/r .


Smaller week 4 VL decline was associated with increased risk of virologic failure .


Within all treatment arms , a less robust week 4 virologic response was associated with higher risk for subsequent virologic failure .


However , between-regimen differences in week 4 VL declines did not parallel the previously reported differences in longer term virologic efficacy in A5202 , suggesting that between-regimen differences in responses were not due to intrinsic differences in antiviral activity .


To investigate the efficacy and effects of transcranial direct current stimulation ( tDCS ) on motor imagery brain-computer interface ( MI-BCI ) with robotic feedback for stroke rehabilitation .


A sham-controlled , randomized controlled trial .


Patients recruited through a hospital stroke rehabilitation program .


Subjects ( N = 19 ) who incurred a stroke 0.8 to 4.3 years prior , with moderate to severe upper extremity functional impairment , and passed BCI screening .


Ten sessions of 20 minutes of tDCS or sham before 1 hour of MI-BCI with robotic feedback upper limb stroke rehabilitation for 2 weeks .


Each rehabilitation session comprised 8 minutes of evaluation and 1 hour of therapy .


Upper extremity Fugl-Meyer Motor Assessment ( FMMA ) scores measured end-intervention at week 2 and follow-up at week 4 , online BCI accuracies from the evaluation part , and laterality coefficients of the electroencephalogram ( EEG ) from the therapy part of the 10 rehabilitation sessions .


FMMA score improved in both groups at week 4 , but no intergroup differences were found at any time points .


Online accuracies of the evaluation part from the tDCS group were significantly higher than those from the sham group .


The EEG laterality coefficients from the therapy part of the tDCS group were significantly higher than those of the sham group .


The results suggest a role for tDCS in facilitating motor imagery in stroke .


To date , the limited degrees of freedom ( DOF ) of most robotic training devices hinders them from providing functional training following stroke .


We developed a 6-DOF exoskeleton ( `` BONES '' ) that allows movement of the upper limb to assist in rehabilitation .


The objectives of this pilot study were to evaluate the impact of training with BONES on function of the affected upper limb , and to assess whether multijoint functional robotic training would translate into greater gains in arm function than single joint robotic training also conducted with BONES .


Twenty subjects with mild to moderate chronic stroke participated in this crossover study .


Each subject experienced multijoint functional training and single joint training three sessions per week , for four weeks , with the order of presentation randomized .


The primary outcome measure was the change in Box and Block Test ( BBT ) .


The secondary outcome measures were the changes in Fugl-Meyer Arm Motor Scale ( FMA ) , Wolf Motor Function Test ( WMFT ) , Motor Activity Log ( MAL ) , and quantitative measures of strength and speed of reaching .


These measures were assessed at baseline , after each training period , and at a 3-month follow-up evaluation session .


Training with the robotic exoskeleton resulted in significant improvements in the BBT , FMA , WMFT , MAL , shoulder and elbow strength , and reaching speed ( p < 0.05 ) ; these improvements were sustained at the 3 month follow-up .


When comparing the effect of type of training on the gains obtained , no significant difference was noted between multijoint functional and single joint robotic training programs .


However , for the BBT , WMFT and MAL , inequality of carryover effects were noted ; subsequent analysis on the change in score between the baseline and first period of training again revealed no difference in the gains obtained between the types of training .


Training with the 6 DOF arm exoskeleton improved motor function after chronic stroke , challenging the idea that robotic therapy is only useful for impairment reduction .


The pilot results presented here also suggest that multijoint functional robotic training is not decisively superior to single joint robotic training .


This challenges the idea that functionally-oriented games during training is a key element for improving behavioral outcomes .


NCT01050231 .


The aim of the present study was to compare vascular healing response between everolimus-eluting stent ( EES ) and biolimus-eluting stent ( BES ) using optical coherence tomography ( OCT ) .


In the NOBORI Biolimus-Eluting Versus XIENCE V/PROMUS Everolimus-Eluting Stent Trial ( NEXT ) , a formal OCT substudy investigated 91 patients ( 55 EES-treated lesions in 48 patients and 51 BES-treated lesions in 43 patients ) with 8-12 months follow-up imaging at 18 centers .


A total of 980 frames with 8,996 struts in EES and 907 frames with 8,745 struts in BES were analyzed .


Mean neointima thickness in EES and BES was 10582m and 9180m , respectively ( P < 0.001 ) .


With regard to stent-treated lesions , the percentage of struts not covered by neointima ( 37 % vs. 910 % , P < 0.001 ) and the frequency of stent-treated lesions with any uncovered struts ( n = 28 , 51 % vs. n = 42 , 82 % ; P < 0.001 ) were significantly lower in EES compared with BES .


In addition , the percentage of malapposed struts ( 0.20.8 % vs. 1.32.8 % , P = 0.006 ) and the frequency of stent-treated lesions with any malapposed struts ( n = 6 , 11 % vs. n = 14 , 27 % ; P = 0.028 ) were significantly lower in EES compared with BES .


Incomplete vascular healing characterized by the presence of struts not covered by neointima and malapposed struts was less common in EES compared with BES .


Pronase , a proteolytic enzyme , is known to improve mucosal visibility during esophagogastroduodenoscopy ( EGD ) , but little is known about its effects on gastric biopsy .


This study assessed whether endoscopic flushing with pronase improves the quality of gastric biopsy .


Consecutive patients who underwent EGD were randomly assigned to either the control group or the pronase group in a prospective setting .


The first biopsy of the identified lesion was performed during endoscopy .


Endoscopic flushing with either 50mL of water and dimethylpolysiloxane ( DMPS ; control group ) or 50mL of water , pronase , sodium bicarbonate , and DMPS ( pronase group ) was then applied to the lesion .


After 5 minutes , the second biopsy was performed 2-3mm away from the first biopsy site .


The thickness of mucus , depth of the specimen , overall diagnostic adequacy , anatomical orientation , and crush artifact were measured to assess the quality of the biopsy .


Of the 208 patients , 10 were not analyzed due to the absence of an identifiable lesion .


Compared with the control group , the pronase group showed significantly decreased thickness of mucus ( P < 0.001 ) , increased depth of biopsy ( P < 0.001 ) , improved anatomical orientation ( P = 0.010 ) , and improved overall diagnostic assessment ( P = 0.011 ) in the second biopsied specimen following endoscopic flushing .


The crush artifact and hemorrhage did not differ between the groups .


Endoscopic flushing with pronase not only improved the depth of biopsy but also the anatomical orientation and overall diagnostic adequacy .


Pronase can be recommended for flushing during EGD to improve the quantity and quality of biopsy .


The importance of adequate nutritional support is well established , but characterising what ` adequate nutrition ' represents remains contentious .


In recent years there has been increasing interest in the concept of ` permissive underfeeding ' where patients are intentionally prescribed less nutrition than their calculated requirements .


The aim of this study was to evaluate the effect of permissive underfeeding on septic and nutrition related morbidity in patients requiring short term parenteral nutrition ( PN ) .


This was a single-blinded randomised clinical trial of 50 consecutive patients requiring parenteral nutritional support .


Patients were randomized to receive either normocaloric or hypocaloric feeding ( respectively 100 % vs. 60 % of estimated requirements ) .


The primary end point was septic complications .


Secondary end points included the metabolic , physiological and clinical outcomes to the two feeding protocols .


Permissive underfeeding was associated with fewer septic complications ( 3 vs. 12 patients ; p = 0.003 ) , and a lower incidence of the systemic inflammatory response syndrome ( 9 vs. 16 patients ; p = 0.017 ) .


Permissively underfed patients had fewer feed related complications ( 2 vs. 9 patients ; p = 0.016 ) .


Permissive underfeeding in patients requiring short term PN appears to be safe and may results in reduced septic and feed-related complications .


NCT01154179 TRIAL REGISTRY : http://clinicaltrials.gov/ct2/show/NCT01154179 .


Unlike conventional hemodialysis treatments , which rely almost solely on diffusion-related mechanisms for solute removal , hemodiafiltration ( HDF ) allows more efficient removal of higher molecular weight toxins due to convective transport mechanisms .


To facilitate the removal of these toxins in HDF treatment modalities , dialyzers with highly efficient high-flux membranes are necessary .


This study assessed the large uremic toxin removal ability of a high-flux dialyzer ( FX CorDiax 60 ) specifically designed to facilitate convective therapies compared with a standard high-flux dialyzer ( FX 60 ) .


In an open , randomized , cross-over , single-center , controlled , prospective clinical study , 30 adult chronic hemodialysis patients were treated by post-dilution online HDF with the FX 60 or the FX CorDiax 60 dialyzer .


All other dialysis parameters were kept constant in both study arms .


The reduction rate ( RR ) of blood urea nitrogen , phosphate , 2-microglobulin ( 2-m ) , myoglobin , prolactin , 1-microglobulin , 1-acid glycoprotein , albumin and total protein as well as the elimination into dialysate was intraindividually compared for the two dialyzer types .


For FX CorDiax 60 versus FX 60 , the RR was significantly higher for blood urea nitrogen ( 86.23 4.14 vs. 84.89 4.59 % , p = 0.015 ) , 2-m ( 84.67 3.79 vs. 81.30 4.82 % , p < 0.0001 ) , myoglobin ( 75.23 10.48 vs. 58.60 12.1 % , p < 0.0001 ) , prolactin ( 72.96 9.68 vs. 56.91 13.01 % , p < 0.0001 ) and 1-microglobulin ( 20.89 18.27 vs. 13.60 12.50 % , p = 0.016 ) .


There were no significant differences in the RR for phosphate , 1-acid glycoprotein , albumin and total protein .


Mass removal was significantly higher with the FX CorDiax 60 than with the FX 60 for 2-m ( 0.26 0.09 vs. 0.24 0.09 g , p = 0.0006 ) , myoglobin ( 1.83 0.89 vs. 1.51 0.76 mg , p = 0.0017 ) , prolactin ( 0.17 0.13 vs. 0.14 0.08 mg , p = 0.02 ) and albumin ( 4.25 3.49 vs. 3.01 2.37 g , p = 0.03 ) .


This study demonstrates that treating patients with an FX CorDiax 60 instead of an FX 60 dialyzer in post-dilution HDF mode significantly increases the elimination of middle molecules .


Inflammation contributes to the development of peripheral artery disease ( PAD ) and may contribute to intermittent claudication by adversely affecting vascular and skeletal muscle function .


We explored the association of inflammation to maximal walking time ( MWT ) in patients with claudication .


Circulating inflammatory biomarkers , including tumor necrosis factor ( TNF - ) , C-reactive protein ( CRP ) , interleukin-6 ( IL-6 ) , and soluble intercellular adhesion molecule 1 ( sICAM ) , were measured in 75 subjects with intermittent claudication as well as in 43 healthy subjects .


Real-time polymerase chain reaction was used to quantify mRNA expression of TNF - , IL-6 , interferon - , and CD36 from peripheral blood monocytes .


Treadmill testing was performed in PAD subjects to assess MWT .


Compared with healthy subjects , PAD subjects had higher levels of circulating TNF - ( P < .0001 ) , CRP ( P = .003 ) , sICAM ( P < .0001 ) , and IL-6 ( P < .0001 ) .


Expression of both IL-6 ( P = .024 ) and CD36 ( P = .018 ) was greater in PAD subjects than in healthy subjects .


Among subjects with PAD , higher gene expression of TNF - was associated inversely with MWT ( P = .01 ) .


MWT was also associated inversely with greater levels of circulating TNF - ( P = .028 ) , CRP ( P = .024 ) , IL-6 ( P = .03 ) , and sICAM ( P = .018 ) .


Systemic inflammation , as indicated by TNF - inflammatory gene expression in peripheral blood monocytes and by circulating biomarker levels , is associated with impairment in walking time in patients with PAD and intermittent claudication .


Weight gain and obesity are common after kidney transplantation , particularly during the first year .


Obesity is a risk factor for the development of new-onset diabetes after transplantation , and is associated with reduced graft survival .


There is a lack of evidence for effective interventions to prevent weight gain after kidney transplantation .


The effect of INTEnsive Nutrition interventions on weight gain after kidney Transplantation ( INTENT ) trial is a single-blind ( outcomes assessor ) , randomised controlled trial to assess the effect of intensive nutrition interventions , including exercise advice , on weight gain and metabolic parameters in the first year after transplantation .


Participants will be randomised during the first post-transplant month to either standard care ( four visits with a renal dietitian over twelve months ) or intensive nutrition intervention ( eight visits with a renal dietitian over the first six months , four visits over the second six months , and three visits over the first six months with an exercise physiologist ) .


In the intensive intervention group , nutrition counselling will be provided using motivational interviewing techniques to encourage quality engagement .


Collaborative goal setting will be used to develop personalised nutrition care plans .


Individualised advice regarding physical activity will be provided by an exercise physiologist .


The primary outcome of the study is weight at six months after transplant , adjusted for baseline ( one month post-transplant ) weight , obesity and gender .


Secondary outcomes will include changes in weight and other anthropometric measures over 12 months , body composition ( in vivo neutron activation analysis , total body potassium , dual-energy X-ray absorptiometry , and bioelectrical impedance ) , biochemistry ( fasting glucose , lipids , haemoglobin A1c and insulin ) , dietary intake and nutritional status , quality of life , and physical function .


There are currently few randomised clinical trials of nutrition interventions after kidney transplantation .


The INTENT trial will thus provide important data on the effect of intensive nutrition interventions on weight gain after transplant and the associated metabolic consequences .


Additionally , by assessing changes in glucose metabolism , the study will also provide data on the feasibility of undertaking larger multi-centre trials of nutrition interventions to reduce the incidence or severity of diabetes after transplantation .


Australian New Zealand Clinical Trials Registry Number : ACTRN12614000155695 .


Between 40,000 and 80,000 pregnant women die annually from pre-eclampsia and eclampsia .


Although magnesium sulphate and anti-hypertensive therapies can reduce the morbidity and mortality associated with pre-eclampsia , the only cure comes with delivery .


Prompt delivery of the baby , preferably by vaginal route , is vital in order to achieve good maternal and neonatal outcomes .


Induction of labour is therefore a critical intervention in order to prevent morbidity to both mother and baby .


Two low cost interventions - oral misoprostol tablets and transcervical Foley catheterization - are already used by some in low resource settings , but their relative risks and benefits are not known .


The trial will compare the risks , benefits , and trade-offs in efficacy , safety , acceptability and cost of misoprostol and Foley catheter for induction in women with preeclampsia or uncontrolled hypertension .


A total of 602 women with an ongoing pregnancy with a live fetus requiring delivery because of pre-eclampsia or uncontrolled hypertension will be randomly assigned to labor induction with a transcervical Foley catheter or oral misoprostol 25 micrograms .


Women will be recruited at two hospitals in Nagpur , India .


The misoprostol group will receive oral misoprostol 25 microgram every 2 hours for a maximum of 12 doses or until active labor commences .


The Foley group will undergo induction using a Foley catheter ( silicone , size 18 F with 30 ml balloon ) which will remain until active labor starts , the Foley catheter falls out , or 12 hours have elapsed .


The primary outcome will be the attainment of vaginal delivery within 24 hours .


Providers administering the treatment and those assessing the outcomes will not be blinded to group assignment .


NCT01801410 ( ClinicalTrials.gov ) .


Tobacco cessation treatments have not been evaluated among Alaska Native ( AN ) adolescents .


This pilot study evaluated the feasibility and the potential efficacy of a targeted cessation intervention for AN youth using a group randomized design .


Eight villages in western Alaska were randomly assigned to receive the intervention ( n = 4 villages ) or a delayed treatment control condition ( written materials only ; n = 4 villages ) .


Ten adolescents aged 12-17 years were targeted from each village with a planned enrollment of 80 .


The intervention was held over a weekend , and youth traveled from their villages to quit tobacco use with other teens .


The intervention comprised 8 hr of group-based counseling .


Talking circles , personal stories from elders , and recreational activities were included to enhance cultural acceptability and participation .


Newsletters were mailed weekly for 5-weeks postprogram .


Assessments were conducted at baseline , week 6 ( end-of-treatment ) , and 6 months .


Self-reported tobacco abstinence was confirmed with salivary cotinine .


Recruitment targets were met in the intervention ( 41 enrolled ) but not in control villages ( 27 enrolled ) .


All intervention participants attended the weekend program .


Retention was high ; 98 % of intervention and 86 % of control participants completed 6-month follow-up .


The 7-day point-prevalence self-reported tobacco abstinence rates for intervention and control participants were 10 % ( 4/41 ) and 0 % ( 0/27 ) at both week 6 and 6 months ( p = .15 ) .


Only 1 adolescent in the intervention condition was biochemically confirmed abstinent at week 6 and none at 6 months .


The intensive individual-focused intervention used in this study was feasible but not effective for tobacco cessation among AN youth .


Alternative approaches are warranted .


The aim of this study was to verify the effects of loaded exercises associated with a task-oriented training ( TOT ) program in the recovery of upper-limb function in individuals with chronic hemiparesis after stroke .


This study used a single-blinded , randomized controlled trial .


Patients were included into two TOT groups : one that performed the task-oriented therapy without load ( TOT group , n = 10 ) and another one that performed task-oriented therapy with personalized resistance ( TOT_ST group , n = 10 ) for 6 wks , for a total of 12 sessions .


Main measures included The Upper Extremity Performance Test , shoulder flexor and handgrip strength , shoulder active range of motion , motor impairment ( Fugl-Meyer Scale ) , and muscle tone .


The TOT_ST group demonstrated better scores relating to unilateral tasks and in the quality aspects of bilateral movements ( The Upper Extremity Performance Test , P = 0.04 ) at the end of rehabilitation protocol .


The highest muscle force gain was reached by the TOT_ST group for the shoulder flexors ( P = 0.001 ) .


Similarly , the active range of motion ( P = 0.01 ) and Fugl-Meyer scores ( P = 0.001 ) were higher in the TOT_ST group compared with the TOT group .


Both groups showed improvement after training .


Strength training was able to intensify the upper-limb rehabilitation , as demonstrated by the superior scores achieved by the TOT_ST group in most of the evaluated parameters .


Muscle strength training might be a pivotal element of the task-oriented rehabilitation program of chronic patients with mild impairment after stroke .


Constipation is a frequent complaint and the combination of a prebiotic and probiotics could have a potentially synergic effect on the intestinal transit .


The present study therefore aims to investigate the combination of polydextrose ( Litesse ) , L. acidophilus NCFM and B. lactis HN019 in a yogurt on intestinal transit in subjects who suffer from constipation .


Patients with constipation were randomly divided into two groups , Control Group ( CG ) and Treatment Group ( TG ) , and had to eat 180 ml of unflavored yogurt every morning for 14 days .


Those in the CG received only yogurt , while the TG received yogurt containing polydextrose , L. acidophilus NCFM ( ATCC 700396 ) and B. lactis HN019 ( AGAL NM97/09513 ) .


Favourable clinical response was assessed since Agachan score had a significant reduction at the end of the study in both groups and tended to be better in the TG .


The subjects in the treatment group also had a shorter transit time at the end of the intervention compared to the control group ( p = 0.01 ) .


The product containing yogurt with polydextrose , B. lactis HN019 and L. acidophilus NCFM significantly shortened colonic transit time after two weeks in the TG compared to CG and may be an option for treatment of constipation .


Hepatocellular carcinoma ( HCC ) is a primary tumor of the liver with poor prognosis .


For early stage HCC , treatment options include surgical resection , liver transplantation , and percutaneous ablation .


Percutaneous ablative techniques ( radiofrequency and microwave techniques ) emerged as best therapeutic options for nonsurgical patients .


We aimed to determine the safety and efficacy of radiofrequency and microwave procedures for ablation of early stage HCC lesions and prospectively follow up our patients for survival analysis .


One Hundred and 11 patients with early HCC are managed in our multidisciplinary clinic using either radiofrequency or microwave ablation .


Patients are assessed for efficacy and safety .


Complete ablation rate , local recurrence , and overall survival analysis are compared between both procedures .


Radiofrequency ablation group ( n = 45 ) and microwave ablation group ( n = 66 ) were nearly comparable as regards the tumor and patients characteristics .


Complete ablation was achieved in 94.2 and 96.1 % of patients managed by radiofrequency and microwave ablation techniques , respectively ( p value 0.6 ) with a low rate of minor complications ( 11.1 and 3.2 , respectively ) including subcapsular hematoma , thigh burn , abdominal wall skin burn , and pleural effusion .


Ablation rates did not differ between ablated lesions 3 and 3-5 cm .


A lower incidence of local recurrence was observed in microwave group ( 3.9 vs. 13.5 % in radiofrequency group , p value 0.04 ) .


No difference between both groups as regards de novo lesions , portal vein thrombosis , and abdominal lymphadenopathy .


The overall actuarial probability of survival was 91.6 % at 1 year and 86.1 % at 2 years with a higher survival rates noticed in microwave group but still without significant difference ( p value 0.49 ) .


Radiofrequency and microwave ablations led to safe and equivalent ablation and survival rates ( with superiority for microwave ablation as regards the incidence of local recurrence ) .


Cooking with Kids ( CWK ) , an experiential school-based food education program , has demonstrated modest influence on fruit and vegetable preference , food and cooking attitudes ( AT ) , and self-efficacy ( SE ) among fourth-grade , mostly low-income Hispanic students in a quasiexperimental study with an inconsistent baseline .


Effect was notably strong for boys and those without previous cooking experience .


The aim of this project was to assess the effect of CWK with a mostly non-Hispanic white sample that assured no previous CWK exposure .


The randomized , controlled assessment of CWK effect on fourth graders was conducted with 257 students in 12 classes in four public schools .


CWK included a 1-hour introductory lesson , three 2-hour cooking classes , and three 1-hour fruit and vegetable tasting sessions led by trained food educators during the school day for one semester .


Fruit preference , vegetable preference , and cooking AT and SE were assessed with a tested 35-item measure , shown to have test-retest reliability .


Univariate analyses considered gender and previous cooking experience .


Intervention efficacy was confirmed in this mostly white sample ( 75 % ; 79 % with previous cooking experience ; 54 % girls ) .


Increases in vegetable preference , AT , and SE were all significantly greater in CWK students with p ( 2 ) of 0.03 , 0.02 , and 0.06 , respectively .


CWK most strongly improved AT and SE for boys without previous cooking experience .


CWK significantly improved fourth-grade students ' vegetable preferences , AT , and SE toward food and cooking , which are factors important to healthful eating and obesity prevention .


Noncookers , especially boys , benefitted from this intervention .


Buruli Ulcer ( BU ) is a tropical infectious skin disease that is currently treated with 8 weeks of intramuscular streptomycin and oral rifampicin .


As prolonged streptomycin administration can cause both oto - and nephrotoxicity , we evaluated its long term toxicity by following-up former BU patients that had received either 4 or 8 weeks of streptomycin in addition to other drugs between 2006 and 2008 , in the context of a randomized controlled trial .


Former patients were retrieved in 2012 , and oto - and nephrotoxicity were determined by audiometry and serum creatinine levels .


Data were compared with baseline and week 8 measurements during the drug trial .


Of the total of 151 former patients , 127 ( 84 % ) were retrieved .


Ototoxicity was present in 29 % of adults and 25 % of children .


Adults in the 8 week streptomycin group had significantly higher hearing thresholds in all frequencies at long term follow-up , and these differences were most prominent in the high frequencies .


In children , no differences between the two treatment arms were found .


Nephrotoxicity that had been detected in 14 % of adults and in 13 % of children during treatment , was present in only 2.4 % of patients at long term follow-up .


Prolonged streptomycin administration in the adult study subjects caused significant persistent hearing loss , especially in the high frequency range .


Nephrotoxicity was also present in both adults and children but appeared to be transient .


Streptomycin should be given with caution especially in patients aged 16 or older , and in individuals with concurrent risks for renal dysfunction or hearing loss .


Basal cell carcinoma ( BCC ) is the most common form of cancer among Caucasians and its incidence continues to rise .


Surgical excision ( SE ) is considered standard treatment , though randomised trials with long-term follow-up are rare .


We now report the long-term results of a randomised trial comparing surgical excision with Mohs ' micrographic surgery ( MMS ) for facial BCC .


408 facial , high risk ( diameter at least 1cm , H-zone location or aggressive histological subtype ) primary BCCs ( pBCCs ) and 204 facial recurrent BCCs ( rBCCs ) were randomly allocated to treatment with either SE or MMS between 5th October 1999 and 27th February 2002 .


The primary outcome was recurrence of carcinoma .


A modified intention to treat analysis was performed .


For primary BCC , the 10-year cumulative probabilities of recurrence were 4.4 % after MMS and 12.2 % after SE ( Log-rank test ( 2 ) 2.704 , p = 0.100 ) .


For recurrent BCC , cumulative 10-year recurrence probabilities were 3.9 % and 13.5 % for MMS and SE , respectively ( Log-rank ( 2 ) 5.166 , p = 0.023 ) .


A substantial proportion of recurrences occurred after more than 5years post-treatment : 56 % for pBCC and 14 % for rBCC .


Fewer recurrences occurred after treatment of high risk facial BCC with MMS compared to treatment with SE .


The proportion of recurrences occurring more than 5years post-treatment was especially high for pBCC , stressing the need for long-term follow-up in patients with high risk facial pBCC .


To evaluate the pharmacokinetic and pharmacodynamic ( PK/PD ) results of three different infusion time regimens of single doses of 600 mg linezolid in healthy Han Chinese volunteers .


We conducted a clinical trial involving 6 male and 6 female healthy Chinese volunteers .


They were randomized to receive intravenous linezolid infusion ( 600 mg/0 .5 hours , 600 mg/2 hours , or 600 mg/4 hours ) in three periods with washout periods of 7 days between each dosage .


Serum linezolid concentration was measured in each subject at pre-dose ( at 0 hours ) until 24 hours after each dose .


The ratio of the area under the serum concentration-time curve ( AUC ) to the minimum inhibitory concentration ( MIC ) , AUC/MIC , was adopted as the major relevant parameter .


Monte Carlo simulation was used to evaluate the probability of target attainment ( PTA ) of these three linezolid regimens .


One subject in 600 mg/0 .5 hours regimen complained of mild pain at the injection site .


No significant difference was found in pharmacokinetic parameters among the three different infusion regimens .


When AUC/MIC was applied as parameter , PTA of 4 hours infusion regimen was much lower than that of the 0.5 hours and 2 hours infusion regimens ( 55.65 % vs. 74.91 % and 72.03 % , respectively ) .


Especially at higher MIC ( 2 g/mL ) , the PTAs of the 0.5 hours and 2 hours infusion regimens decreased to 57.2 % and 50.1 % , respectively , while that of the 4 hours infusion regimen dropped sharply to only 25.95 % .


When T > MIC was applied as a parameter , PTA of the 0.5 hours regimen was higher than 90 % , while the 2 hours and 4 hours regimens remained 100 % .


Our findings suggest that 2 hours infusion of linezolid at a fixed dose ( 600 mg ) regimen is appropriate to achieve the safety and efficacy against MRSA-caused infections in Chinese adults .


To evaluate the effectiveness of 200 mg of daily vaginal natural progesterone to prevent preterm birth in women with preterm labour .


Multicentre , randomised , double-blind , placebo-controlled trial .


Twenty-nine centres in Switzerland and Argentina .


A total of 385 women with preterm labour ( 24 ( 0/7 ) to 33 ( 6/7 ) weeks of gestation ) treated with acute tocolysis .


Participants were randomly allocated to either 200 mg daily of self-administered vaginal progesterone or placebo within 48 hours of starting acute tocolysis .


Primary outcome was delivery before 37 weeks of gestation .


Secondary outcomes were delivery before 32 and 34 weeks , adverse effects , duration of tocolysis , re-admissions for preterm labour , length of hospital stay , and neonatal morbidity and mortality .


The study was ended prematurely based on results of the intermediate analysis .


Preterm birth occurred in 42.5 % of women in the progesterone group versus 35.5 % in the placebo group ( relative risk [ RR ] 1.2 ; 95 % confidence interval [ 95 % CI ] 0.93-1 .5 ) .


Delivery at < 32 and < 34 weeks did not differ between the two groups ( 12.9 versus 9.7 % ; [ RR 1.3 ; 95 % CI 0.7-2 .5 ] and 19.7 versus 12.9 % [ RR 1.5 ; 95 % CI 0.9-2 .4 ] , respectively ) .


The duration of tocolysis , hospitalisation , and recurrence of preterm labour were comparable between groups .


Neonatal morbidity occurred in 44 ( 22.8 % ) cases on progesterone versus 35 ( 18.8 % ) cases on placebo ( RR : 1.2 ; 95 % CI 0.82-1 .8 ) , whereas there were 4 ( 2 % ) neonatal deaths in each study group .


There is no evidence that the daily administration of 200 mg vaginal progesterone decreases preterm birth or improves neonatal outcome in women with preterm labour .


Competency-based education and simulation are being used more frequently in surgical skills curricula .


We explored a novel student-led learning paradigm , which allows trainees to become more active participants in the learning process while maintaining expert guidance and supervision .


Twelve first-year orthopedic residents were randomized to either a student-led ( SL ) or a traditional instructor-led group during an intensive , month-long , laboratory-based technical skills training course .


A rigorous qualitative-description approach was used for analysis .


Four prominent themes emerged : instructional style , feedback , peer and instructor collaboration , and self-efficacy .


Compared with the instructor-led group , there was more peer assistance , feedback , collaboration , and hands-on and active learning observed in the SL group .


The flexible and socially rich nature of the SL learning environment may aid in development of both technical and nontechnical skills early in residency and ultimately privilege later clinical learning .


A low-cost virtual reality system that translates movements of the hand , fingers , and thumb into game play was designed to provide a flexible and motivating approach to increasing adherence to home-based rehabilitation .


Effectiveness depends on adherence , so did patients use the intervention to the recommended level ?


If not , what reasons did they give ?


The purpose of this study was to investigate these and related questions .


A prospective cohort study , plus qualitative analysis of interviews , was conducted .


Seventeen patients recovering from stroke recruited to the intervention arm of a feasibility trial had the equipment left in their homes for 8 weeks and were advised to use it 3 times a day for periods of no more than 20 minutes .


Frequency and duration of use were automatically recorded .


At the end of the intervention , participants were interviewed to determine barriers to using it in the recommended way .


Duration of use and how many days they used the equipment are presented for the 13 participants who successfully started the intervention .


These figures were highly variable and could fall far short of our recommendations .


There was a weak positive correlation between duration and baseline reported activities of daily living .


Participants reported lack of familiarity with technology and competing commitments as barriers to use , although they appreciated the flexibility of the intervention and found it motivating .


The small sample size limits the conclusions that can be drawn .


Level of use is variable and can fall far short of recommendations .


Competing commitments were a barrier to use of the equipment , but participants reported that the intervention was flexible and motivating .


It will not suit everyone , but some participants recorded high levels of use .


Implications for practice are discussed .


To determine the effect of choice of inhalational anaesthetic ( sevoflurane vs propofol ) on the incidence and severity of postoperative cognitive dysfunction ( POCD ) in elderly patients ( aged 60 years ) with mild cognitive impairment ( MCI ) .


Elderly patients with MCI undergoing radical rectal resection were randomly assigned to receive sevoflurane or propofol general anaesthesia .


Cognitive function was assessed using neuropsychological testing before and 7 days after surgery .


POCD severity was graded as mild , moderate or severe using standard deviation cut-offs .


At 7 days after surgery , the incidence of POCD was 29.7 % in the propofol group ( n = 101 ) and 33.3 % in the sevoflurane group ( n = 99 ) .


There was a signicant between-group difference for POCD severity : sevoflurane anaesthesia had a more severe impact on cognitive function than propofol anaesthesia .


There was no difference in the incidence of POCD at 7 days after radical rectal resection under sevoflurane or propofol-based general anaesthesia .


Both propofol and sevoflurane were associated with negative cognitive effects , but sevoflurane had a more severe impact on cognitive function than propofol , in elderly patients with MCI .


To compare the safety and efficacy of sedation induced by dexmedetomidine and propofol after oral and maxillofacial surgery .


In this trial , 66 patients 18 to 50 years old received oral and maxillofacial surgery and required postoperative nasal endotracheal intubation under overnight sedation with dexmedetomidine or propofol .


The dexmedetomidine group ( group D ) received dexmedetomidine 1.0 g/kg intravenously for 10 minutes after entering the recovery room .


The dose was maintained by giving an intravenous injection of dexmedetomidine 0.4 g/kg .


The injection rate could be modulated from 0.2 to 0.7 g/kg/hour in the intensive care unit ( ICU ) .


If the Ramsay score was lower than 2 and involuntary limb movement occurred , other sedatives were used .


The propofol group ( group P ) was given propofol 0.1 mg/kg intravenously for 10 minutes after entering the recovery room and then maintained with intravenous injections of propofol 1 to 2 mg/kg/hour in the recovery room and ICU .


The oxygen desaturation of group P was higher than that of group D ( at the first sedation time of 30 minutes ) , but the mean blood pressure of group P was significantly lower than that of group D at the 10-minute time point .


The Ramsay score was higher in group D after the first 3 hours of sedation than in group P ( P < .05 ) .


Dexmedetomidine showed similar safety and efficacy as propofol and could be used for tube-retaining sedation after oral and maxillofacial surgery .


This study sought to prospectively study the impact of an appropriate use criteria ( AUC ) - based educational intervention on outpatient transthoracic echocardiography ( TTE ) ordering by physicians-in-training .


AUC were developed in response to concerns about inappropriate utilization .


It is unknown whether an educational intervention can reduce inappropriate outpatient TTE .


We conducted a randomized control trial in which physicians-in-training were randomized to an AUC-based educational intervention or a control group at an academic medical center in Boston , Massachusetts .


The primary endpoints were the rates of inappropriate and appropriate TTE .


For the cardiology physicians-in-training , the proportion of inappropriate TTE was significantly lower in the intervention than in the control group ( 13 % vs. 34 % , p < 0.001 ) .


As a corollary , the proportion of appropriate TTE ordered by the intervention group was significantly higher than that of the control group ( 81 % vs. 58 % , p < 0.001 ) .


The odds of ordering an appropriate TTE in the cardiology intervention group was 2.7 ( 95 % confidence interval [ CI ] : 1.5 to 5.1 , p = 0.002 ) relative to the control group .


The internal medicine physicians-in-training ordered a small number of TTE overall , and there was a trend toward significant odds of ordering an appropriate TTE in the intervention group relative to the control group ( odds ratio [ OR ] : 8.1 , 95 % CI : 0.95 to 69.0 , p = 0.055 ) .


Six clinical scenarios accounted for 75 % of all inappropriate TTE , with the 3 most common inappropriate indications being routine surveillance ( < 1 year ) of known cardiomyopathy without a change in clinical status , routine surveillance of known small pericardial effusion , and routine surveillance of ventricular function with known coronary artery disease and no change in clinical status .


In cardiology fellows with a high rate of ordering inappropriate TTE , an AUC-based educational and feedback intervention reduced the proportion of inappropriate outpatient TTE and increased the proportion of appropriate outpatient TTE .


( Educational Intervention to Reduce Outpatient Inappropriate Transthoracic Echocardiograms ; NCT01944202 ) .


In patients receiving inhaled medication , dissatisfaction with and difficulty in using the inhaler can affect treatment adherence .


The incidence of handling errors is typically higher in the elderly than in younger people .


The aim of the study was to assess inhaler preference for and handling errors with the ELLIPTA dry powder inhaler ( DPI ) , ( GSK ) , compared with the established BREEZHALER , a single-dose capsule DPI ( Novartis ) , in inhalation device-nave Japanese volunteers aged 40 years .


In this open-label , nondrug interventional , crossover DPI preference study comparing the ELLIPTA DPI and BREEZHALER , 150 subjects were randomized to handle the ELLIPTA or BREEZHALER DPIs until the point of inhalation , without receiving verbal or demonstrative instruction ( first attempt ) .


Subjects then crossed over to the other inhaler .


Preference was assessed using a self-completed questionnaire .


Inhaler handling was assessed by a trained assessor using a checklist .


Subjects did not inhale any medication in the study , so efficacy and safety were not measured .


The ELLIPTA DPI was preferred to the BREEZHALER by 89 % of subjects ( odds ratio [ OR ] 70.14 , 95 % confidence interval [ CI ] 33.69-146 .01 ; P-value not applicable for this inhaler ) for ease of use , by 63 % of subjects ( OR 2.98 , CI 1.87-4 .77 ; P < 0.0001 ) for ease of determining the number of doses remaining in the inhaler , by 91 % for number of steps required , and by 93 % for time needed for handling the inhaler .


The BREEZHALER was preferred to the ELLIPTA DPI for comfort of the mouthpiece by 64 % of subjects ( OR 3.16 , CI 1.97-5 .06 ; P < 0.0001 ) .


The incidence of handling errors ( first attempt ) was 11 % with ELLIPTA and 68 % with BREEZHALER ; differences in incidence were generally similar when analyzed by age ( < or 65 years ) or sex .


These data , obtained in an inhalation device-nave population , suggest that the ELLIPTA DPI is preferred to an established alternative based on its ease-of-use features and is associated with fewer handling errors .


To compare the clinical results and the intraoperative and postoperative performance of an additional sulcus-fixated multifocal intraocular lens ( IOL ) with a conventional multifocal IOL implanted in the capsular bag .


In this prospective , randomised , monocentric study , the intraoperative and postoperative outcomes after implantation of an additional sulcus-fixated multifocal IOL ( group A ; 29 eyes ) and a conventional , multifocal posterior chamber IOL ( group B ; 25 eyes ) are compared .


1-year postoperatively , visual acuity , contrast sensitivity and defocus curve were determined .


Patients implanted bilaterally with the same IOL filled in a questionnaire to assess patient satisfaction .


Between the groups , only slight differences were found in visual acuity at all distances .


All patients achieved an uncorrected distance visual acuity of 0.1 LogMAR or better and an uncorrected intermediate/near visual acuity of 0.3 LogMAR or better .


Slightly better results in contrast sensitivity were achieved in group A at high spatial frequencies under almost all lighting conditions .


Patient survey showed a higher degree of satisfaction of patients in group B , while a smaller proportion of group A stated to have disturbing light phenomena .


Only small functional differences between the examined methods were found .


Both types of multifocal IOL performed well at all distances .


There were no intraoperative and postoperative complications in the add-on IOL group which affirms the high safety level such as with conventional multifocal IOL in the capsular bag .


We performed a pooled analysis based on patient-level data from the TITAX-AMI and BASE-ACS trials to evaluate the outcome of titanium-nitride-oxide-coated bioactive stents vs drug-eluting stents in patients with ST-segment elevation myocardial infarction at 2-year follow-up .


The TITAX-AMI trial compared bioactive stents with paclitaxel-eluting stents in 425 patients with acute myocardial infarction .


The BASE-ACS trial compared bioactive stents with everolimus-eluting stents in 827 patients with acute coronary syndrome .


The primary endpoint for the pooled analysis was major adverse cardiac events : a composite of cardiac death , recurrent myocardial infarction , or ischemia-driven target lesion revascularization at 2-year follow-up .


The pooled analysis included 501 patients ; 245 received bioactive stents , and 256 received drug-eluting stents .


The pooled bioactive stent group was associated with a risk ratio of 0.85 for major adverse cardiac events ( 95 % confidence interval , 0.53-1 .35 ; P = .49 ) compared to the pooled drug-eluting stent group .


Similarly , the pooled bioactive stent group was associated with a risk ratio of 0.71 for cardiac death ( 95 % confidence interval , 0.26-1 .95 ; P = .51 ) , 0.44 for recurrent myocardial infarction ( 95 % confidence interval , 0.20-0 .97 ; P = .04 ) , and 1.39 for ischemia-driven target lesion revascularization ( 95 % confidence interval , 0.74-2 .59 ; P = .30 ) , compared to the pooled drug-eluting stent group .


These results were confirmed by propensity-score adjusted analysis of the combined datasets .


In patients with ST-segment elevation myocardial infarction , bioactive stents were associated with lower rates of recurrent myocardial infarction compared to drug-eluting stents at 2-year follow-up ; yet , the rates of cardiac death and ischemia-driven target lesion revascularization were similar .


Dissemination of research results to study participants and stakeholders and provision of proven effective products in the immediate post-trial period are core elements of the conduct of biomedical HIV prevention clinical trials .


Few biomedical HIV prevention trials have demonstrated HIV protection with novel interventions , and thus , communication of positive trial results and provision of an effective product have not been tested in many situations .


In July 2011 , the independent Data and Safety Monitoring Board of the Partners PrEP Study , a randomized , placebo-controlled efficacy trial of daily oral antiretroviral preexposure prophylaxis ( PrEP ) for HIV prevention among 4747 African heterosexual HIV serodiscordant couples , recommended discontinuation of the trial 's placebo arm due to demonstration of PrEP efficacy .


We describe dissemination of results , discontinuation of the placebo arm , and provision of active PrEP to participants ' formerly assigned placebo .


Within 72 hours , of the Data and Safety Monitoring Board meeting the study results were publicly released and disseminated to stakeholders and study participants .


Within 3 months , the study protocol was modified to permit participants initially assigned to the study 's placebo arm to be offered active PrEP .


Of the 1418 participants initially randomized to placebo who were clinically eligible to receive PrEP , 89.1 % ( 1264/1418 ) consented .


Prompt dissemination of a positive HIV prevention trial result and subsequent provision of effective product to research participants was feasible and efficient for > 4700 HIV serodiscordant couples in East Africa .


The extent to which study sponsors can assure continued product access to research participants remains a subject of discussion for future HIV prevention clinical trials .


To evaluate the heating and magnetic field interactions of fixed orthodontic appliances with different wires and ligaments in a 3-T MRI environment and to estimate the safety of these orthodontic materials .


40 non-carious extracted human maxillary teeth were embedded in polyvinyl chloride boxes , and orthodontic brackets were bonded .


Nickel-titanium and stainless steel arch wires , and elastic and stainless steel ligaments were used to obtain four experimental groups in total .


Specimens were evaluated at 3T for radiofrequency heating and magnetic field interactions .


Radiofrequency heating was evaluated by placing specimens in a cylindrical plastic container filled with isotonic solution and measuring changes in temperature after T1 weighted axial sequencing and after completion of all sequences .


Translational attraction and torque values of specimens were also evaluated .


One-way ANOVA test was used to compare continuous variables of temperature change .


Significance was set at p < 0.05 .


None of the groups exhibited excessive heating ( highest temperature change : < 3.04 C ) , with the maximum increase in temperature observed at the end of the T1 weighted axial sequence .


Magnetic field interactions changed depending on the material used .


Although the brackets presented minor interactions that would not cause movement in situ , nickel-titanium and stainless steel wires presented great interactions that may pose a risk for the patient .


The temperature changes of the specimens were considered to be within acceptable ranges .


With regard to magnetic field interactions , brackets can be considered `` MR safe '' ; however , it would be safe to replace the wires before MRI .


To observe differences of clinical therapeutic effects between deep-oblique acupuncture with long needle and regular perpendicular acupuncture at Guanyuan ( CV 4 ) for urinary retention to explore standard acupuncture method in clinic .


One hundred and thirty-two cases of urinary retention were randomly divided into an observation group ( 78 cases ) and a control group ( 54 cases ) .


Needles with 75 mm in length were deeply and obliquely inserted into Guanyuan ( CV 4 ) in the observation group while needles with 40 mm in length were perpendicularly inserted .


Clinical therapeutic effects in two groups were observed .


After treatment the total effective rate was 80.8 % ( 63/78 ) in the observation group and 57.4 % ( 31/54 ) in the control group , which had significant difference between two groups ( P < 0.05 ) .


The curative effect of postpartum retention of urine was obviously superior to that of postoperative and prostate-induced urinary retention in the ebservation group , and the effect of urinary retention due to different etiology in the observation was also superior to that in the control group in the ebservation group [ in the observation group total effective rate was 88.6 % ( 47/53 ) in postpartum retention of urine , 50.0 % ( 3/6 ) in prostate-induced urinary retention and 68.4 % ( 13/19 ) in orthopedic postoperative retention of urine while in the control group total effective rate was 69.4 % ( 25/36 ) in postpartum retention of urine , 20.0 % ( 1/5 ) in prostate-induced urinary retention and 38.5 % ( 5/13 ) in orthopedic postoperative retention of urine ) ] .


The deep-oblique acupuncture with long needle at Guanyuan ( CV 4 ) has significant curative effect on urinary retention in clinic , especially for patients with postpartum urinary retention , which could be taken as standard acupuncture method .


Knee osteoarthritis is a major cause of disability in the aging population .


Based on pathological , magnetic resonance imaging ( MRI ) and arthroscopy studies , progressive osteoarthritis involves all tissues of the joint and includes bone marrow lesions , synovial proliferation , fat pad inflammation , and high subchondral bone turnover .


Recent research suggests that abnormal perfusion in bone marrow lesions , fat pads , and subchondral bone is associated with pain in knee osteoarthritis , and that dynamic contrast-enhanced MRI is a promising method for studying micro-perfusion alteration in knee osteoarthritis .


Traditional Chinese Medicine approaches have been employed for thousands of years to relieve knee osteoarthritis pain .


Among herbal medicines , the Jingui external lotion is the preferred and most commonly used method in China to reduce pain in patients with knee osteoarthritis ; however , there is a lack of validated evidence for its effectiveness .


The purpose of this study is to explore the effectiveness of Jingui external lotion for the management of painful knee osteoarthritis in a short-term study .


In addition , we will assess micro-perfusion alteration in the patellar fat pad as well as the femur and tibia subchondral bone via dynamic contrast-enhanced MRI .


This trial is a randomized , controlled study .


A total of 168 patients will be randomized into the following two groups : 1 ) the Jingui external lotion group ( treatment group ) ; and 2 ) the placebo lotion group ( control group ) .


In both groups , lotion fumigation and external washing of the patients ' knees will be administered twice a day for 14 consecutive days .


Follow-up will be at regular intervals during a 4-week period with a visual analog scale to assess pain , and additional characterization with the Western Ontario and McMaster Universities Index score ; rescue medication will be recorded as the extent and time pattern .


In addition , micro-perfusion alteration in the patellar fat pad , femur and tibia subchondral bone will be assessed via dynamic contrast-enhanced MRI .


This study will provide clinical evidence of the efficacy of Jingui external lotion in treating knee osteoarthritis , and it will be the first randomized controlled trial to investigate micro-perfusion alteration of knee osteoarthritis with Traditional Chinese Medicine external lotion via dynamic contrast-enhanced MRI .


ClinicalTrials.gov identifier : ChiCTR-TRC-14004727 ; 31 May 2014 .


Reports of prevalence of spinal pain indicate the prevalence of thoracic pain in approximately 13 % of the general population compared to 32 % of the population with neck pain and 43 % of the population with low back pain during the past year .


Even though , thoracic pain is less common than neck or low back pain , the degree of disability resulting from thoracic pain disorders seems to be similar to other painful conditions .


Interventions in managing chronic thoracic pain are also less frequent , leading to the paucity of literature about various interventions in managing chronic thoracic pain .


Thoracic intervertebral discs and thoracic facet joints have been shown to be pain generators , even though thoracic radicular pain is very infrequent .


Thoracic epidural injections are one of the commonly performed procedures in managing thoracic pain .


The efficacy of thoracic epidural injections has not been well studied .


A randomized , double-blind , active controlled trial .


Private interventional pain management practice and specialty referral center in the United States .


The primary objective was to assess the effectiveness of thoracic interlaminar epidural injections in providing effective pain relief and improving function in patients with chronic mid and/or upper back pain .


One hundred and ten patients were randomly assigned into 2 groups with 55 patients in each group receiving either local anesthetic alone ( Group I ) or local anesthetic with steroids ( Group II ) .


Randomization was performed by computer-generated random allocation sequence by simple randomization .


Outcomes were assessed utilizing Numeric Rating Scale ( NRS ) , the Oswestry Disability Index ( ODI ) 2.0 , employment status , and opioid intake .


The patients experiencing greater than 3 weeks of significant improvement with the first 2 procedures were considered as successful .


Others were considered as failed participants .


Significant improvement was defined as a decrease of greater than 50 % NRS scores and ODI scores with measurements performed at baseline , 3 , 6 , 12 , 18 , and 24 months post treatment .


Significant improvement was seen in 71 % in Group I and 80 % in Group II at the end of 2 years with all participants ; however , improvement was seen in 80 % and 86 % when only successful patients were considered .


Therapeutic procedural characteristics showed 5 to 6 procedures per 2 years with total average relief of 80 weeks in Group I and 78 weeks in Group II in the successful patient category ; whereas , it was 71 and 72 weeks when all patients were considered .


Limitations of this assessment include lack of a placebo group .


Based on the results of this trial , it is concluded that chronic thoracic pain of non-facet joint origin may be managed conservatively with thoracic interlaminar epidural injections with or without steroids .


Falls are common in older people and are associated with substantial health-care costs .


A recent randomized controlled trial of a multifaceted podiatric medical intervention demonstrated a 36 % reduction in the fall rate over 12 months .


We evaluated the acceptability of and levels of satisfaction with this intervention in the older people who participated in the trial .


Participants allocated to the intervention group ( which included a home-based program of foot and ankle exercises , assistance with the purchase of safe footwear when necessary , and provision of prefabricated foot orthoses ) completed a structured questionnaire 6 months after they had received the intervention .


The questions addressed participants ' perceptions of their balance and foot and ankle strength , the perceived difficulty of the exercise program , and the degree of satisfaction with the footwear and orthoses provided .


Of 153 participants , 134 ( 87.6 % ) attended the 6-month follow-up assessment and completed the questionnaire .


Most participants perceived improvements in balance ( 62.7 % ) and foot and ankle strength ( 74.6 % ) after 6 months of performing the exercises , and 86.6 % considered the difficulty level of the exercises to be `` about right . ''


Most participants reported that they were somewhat or very satisfied with the footwear ( 92.3 % ) and orthoses ( 81.6 % ) provided .


The multifaceted podiatric medical intervention used in this trial was generally perceived to be beneficial and demonstrated high levels of satisfaction among participants .


Further research is now required to evaluate the feasibility of implementing the intervention in a range of clinical practice settings .


The effect of teaching crisis resource management skills on the resuscitation performance of pediatric residents is unknown .


The primary objective of this pilot study was to determine if teaching crisis resource management to residents leads to improved clinical and crisis resource management performance in simulated pediatric resuscitation scenarios .


A prospective , randomized control pilot study .


Simulation facility at tertiary pediatric hospital .


Junior pediatric residents .


Junior pediatric residents were randomized to 1 hour of crisis resource management instruction or no additional training .


Time to predetermined resuscitation tasks was noted in simulated resuscitation scenarios immediately after intervention and again 3 months post intervention .


Crisis resource management skills were evaluated using the Ottawa Global Rating Scale .


Fifteen junior residents participated in the study , of which seven in the intervention group .