Fluoroscopy time was 18 4 seconds for the CAS group and 114 38 seconds for the control group .


Postoperative CT scans demonstrated 1.5 0.6 mm maximum deviation from the planned ideal screw .


No significant differences were found in the accuracy between methods , the number of guidewire attempts , or the total surgical time .


Computer-assisted surgery navigation of dorsal percutaneous scaphoid screw placement takes on average 5 minutes longer to set up , but leads to significantly reduced guidewire placement time and no differences in overall procedural time .


This CAS method was as accurate as the traditional method and resulted in an approximate 6-fold reduction in fluoroscopy time .


This is an effective imaging alternative to the mini C-arm for scaphoid fixation using existing intraoperative CT scanners and navigation software .


Sodium drink is used as a countermeasure against body fluid loss .


However , high concentrations of sodium may cause gastrointestinal upset ( e.g. , diarrhea ) .


We sought to determine the sodium concentration that induces hypervolemia with a minimal risk of gastrointestinal disturbance .


Eight healthy active males rested in a chair and ingested a given amount ( 16-17 ml kg body mass ( -1 ) ) of water ( W ) or solution containing 60 , 120 or 180 mmol l ( -1 ) Na ( + ) ( 60 , 120 and 180Na trials ) in 6 equal portions at 10 min intervals .


To standardize their hydration status , subjects consumed the same meal and water 2 h before each trial .


Drink trials were performed on separate days , and the order was randomized .


The change in plasma volume ( PV ) from pre-drink status was estimated from the hemoglobin concentration and hematocrit every 30 min for 150 min after initiation of drinking .


Subjects began trials in a euhydrated state , as reflected by their plasma osmolality ( in mmol l ( -1 ) : W , 289.4 1.4 ; 60Na , 287.0 3.5 ; 120Na , 287.6 2.3 ; 180Na , 288.9 3.3 ) .


At 120 min , PV had not increased from the pre-drink value in the W ( -0.8 4.5 % ) or 60Na ( 2.4 4.9 % ) trials , but it increased to similar degrees in the 120Na ( 7.2 4.6 % ) and 180Na ( 9.4 6.6 % ) trials .


No diarrhea was reported in the W or 60Na trials , but it was reported in the 120Na ( n = 1 ) and 180Na ( n = 6 ) trials .


Beverages containing 120 mmol l ( -1 ) Na ( + ) induce hypervolemia with a minimum incidence of gastrointestinal problems .


It is unclear whether radial compared with femoral access improves outcomes in unselected patients with acute coronary syndromes undergoing invasive management .


We did a randomised , multicentre , superiority trial comparing transradial against transfemoral access in patients with acute coronary syndrome with or without ST-segment elevation myocardial infarction who were about to undergo coronary angiography and percutaneous coronary intervention .


Patients were randomly allocated ( 1:1 ) to radial or femoral access with a web-based system .


The randomisation sequence was computer generated , blocked , and stratified by use of ticagrelor or prasugrel , type of acute coronary syndrome ( ST-segment elevation myocardial infarction , troponin positive or negative , non-ST-segment elevation acute coronary syndrome ) , and anticipated use of immediate percutaneous coronary intervention .


Outcome assessors were masked to treatment allocation .


The 30-day coprimary outcomes were major adverse cardiovascular events , defined as death , myocardial infarction , or stroke , and net adverse clinical events , defined as major adverse cardiovascular events or Bleeding Academic Research Consortium ( BARC ) major bleeding unrelated to coronary artery bypass graft surgery .


The analysis was by intention to treat .


The two-sided was prespecified at 0025 .


The trial is registered at ClinicalTrials.gov , number NCT01433627 .


We randomly assigned 8404 patients with acute coronary syndrome , with or without ST-segment elevation , to radial ( 4197 ) or femoral ( 4207 ) access for coronary angiography and percutaneous coronary intervention .


369 ( 88 % ) patients with radial access had major adverse cardiovascular events , compared with 429 ( 103 % ) patients with femoral access ( rate ratio [ RR ] 085 , 95 % CI 074-099 ; p = 00307 ) , non-significant at of 0025.410 ( 98 % ) patients with radial access had net adverse clinical events compared with 486 ( 117 % ) patients with femoral access ( 083 , 95 % CI 073-096 ; p = 00092 ) .


The difference was driven by BARC major bleeding unrelated to coronary artery bypass graft surgery ( 16 % vs 23 % , RR 067 , 95 % CI 049-092 ; p = 0013 ) and all-cause mortality ( 16 % vs 22 % , RR 072 , 95 % CI 053-099 ; p = 0045 ) .


In patients with acute coronary syndrome undergoing invasive management , radial as compared with femoral access reduces net adverse clinical events , through a reduction in major bleeding and all-cause mortality .


The Medicines Company and Terumo .


This study investigated whether a tailored approach to heparin and protamine management improved thromboelastometric parameters after cardiopulmonary bypass and reduced postoperative blood loss compared with activated coagulation time ( ACT ) - based fixed target heparin and protamine management .


Randomized controlled study .


Tertiary university hospital .


Patients undergoing elective valve surgery ( n = 38 ) .


Heparin and protamine management were based either on the ACT ( n = 19 ) or hemostasis management system ( HMS ) measurements ( n = 19 ; HMS Plus ; Medtronic , Minneapolis , MN ) .


The target ACT for initiation of cardiopulmonary bypass was 480 seconds .


Study variables included rotational thromboelastometry EXTEM ( extrinsic coagulation ) , HEPTEM ( intrinsic coagulation with heparinase ) , and FIBTEM ( fibrin part of clot formation ) tests and 24-hour blood loss .


The use of HMS reduced the median protamine-to-heparin ratio from 1.00 ( 1.00-1 .00 ) to 0.62 ( 0.56-0 .66 ; p < 0.001 ) .


The ACT group showed a prolonged postbypass clotting time for both EXTEM ( 86 13 seconds v 78 10 seconds ; p = 0.05 ) and HEPTEM ( 217 58 seconds v 183 24 seconds ; p = 0.03 ) tests .


There was a moderate correlation between protamine dosing with the EXTEM and HEPTEM clotting time ( r = 0.42 ; p = 0.009 and r = 0.38 ; p = 0.02 , respectively ) .


The number of patients with more than 450 mL/24 hours was higher in the ACT than in the HMS group ( 42 % v 12 % ; p = 0.04 ) .


Individualized heparin and protamine management decreased the protamine-to-heparin ratio , improved postbypass thromboelastometric hemostatic parameters , and reduced the incidence of severe blood loss compared with an ACT-based strategy , supporting the added value of this approach for hemostatic optimization during cardiac surgery .


Radiopharmaceutical use may improve the survival time of patients with castrate-resistant prostate cancer and bone metastases .


Whether androgen-deprivation therapy ( ADT ) combined with bone-targeted therapy provides a clinical benefit to patients with advanced castrate-sensitive prostate cancer has not been investigated .


Eighty male patients were enrolled , and 79 were randomized : 40 to the control arm and 39 to the strontium-89 ( Sr-89 ) arm .


After randomization , patients in both study arms received ADT , doxorubicin , and zoledronic acid .


Kaplan-Meier methodology was used to evaluate the progression-free survival ( PFS ) time .


Multivariate Cox proportional hazards regression was used to evaluate the effects of Sr-89 after controlling for the number of bone metastases .


The median follow-up time for the 29 patients alive at the last follow-up was 76.9 months ( range , 0.07-103 .4 months ) .


The median PFS time was 18.5 months ( 95 % confidence interval , 9.7-49 .4 months ) for the control arm and 12.9 months ( 95 % confidence interval , 8.9-72 .5 months ) for the Sr-89 arm ( P = .86 ) .


No patient developed myelodysplastic syndrome or a hematologic malignancy .


An unplanned subgroup analysis suggested increased efficacy of bone-targeted therapy with a greater extent of bone involvement ( ie , > 6 bone metastases vs 6 bone metastases on the bone scan ) .


The data showed that bone-targeted therapy using 1 dose of Sr-89 combined with chemohormonal ablation therapy did not favorably affect the PFS of patients with castrate-sensitive prostate cancer .


The combined therapy was feasible and safe .


Whether such bone-targeted therapy provides a favorable outcome for those patients with a greater tumor burden in the bone warrants further investigation .


Perioperative hemorrhage is an important concern during orthognathic surgery .


The purpose of this study was to assess the effect of tranexamic acid ( TXA ) irrigation on perioperative hemorrhage during orthognathic surgery .


In this double-blind , randomized controlled clinical trial , 56 participants who underwent orthognathic surgery were divided into 2 groups .


The patients in the first group received TXA irrigation with normal saline ( 1 mg/mL ) , and the patients in the second group had normal saline for irrigation during orthognathic surgery .


Age , gender , operation duration , the amount of irrigation solution used , and preoperative hemoglobin , hematocrit , and weight were the variables that were studied .


The use of TXA solution for irrigation was the predictive factor of the study .


Each group consisted of 28 patients .


Group 1 consisted of 15 male patients ( 53.6 % ) and 13 female patients ( 46.4 % ) and group 2 consisted of 14 male patients ( 50 % ) and 14 female patients ( 50 % ) .


There was no difference in the distributions of the variables between the 2 groups , except for the duration of the operation .


The mean duration of the operation was 3.94 0.61 hours in group 1 and 4.17 0.98 hours in group 2 , and the difference in this respect between the 2 groups was statistically significant ( P < .05 ) .


The mean intraoperative blood loss was 817.85 261.83 mL in group 1 and 575.00 286.90 mL in group 2 ( P < .05 ) .


The mean volume of irrigation was 1,057.14 407.04 mL in group 1 and 843.57 275.48 mL in group 2 ( P > .05 ) .


TXA is effective in reducing intraoperative blood loss in patients for whom substantial blood loss is anticipated .


This experimental study examined whether listening to self-chosen music after stress exposure improves mood , decreases subjective arousal and rumination , and facilitates cardiovascular recovery .


Participants ( N = 123 ) were exposed to a mental arithmetic task with harassment to induce stress .


Afterward , participants were randomly assigned to one of four `` recovery '' conditions where they ( 1 ) listened to self-chosen relaxing music , ( 2 ) listened to self-chosen happy music , ( 3 ) listened to an audio book , or ( 4 ) sat in silence .


After this 5-minute `` recovery manipulation period , '' participants sat in silence for another 5 minutes .


Systolic blood pressure , diastolic blood pressure , and heart rate were continuously measured .


The recovery conditions caused differences in positive affect ( F ( 3,119 ) = 13.13 , p < .001 ) and negative affect ( F ( 3,119 ) = 2.69 , p = .049 ) .


As expected , mood improved while listening to either relaxing music or happy music .


The conditions showed no differences in subjective arousal ( F ( 3,117 ) = 2.03 , p = .11 ) and rumination ( F ( 3,119 ) = 1.10 , p = .35 ) .


Systolic blood pressure recovery , however , differed between the conditions ( linear time trend : F ( 3,116 ) = 4.50 , p = .005 ; quadratic time trend : F ( 3,115 ) = 5.24 , p = .002 ) .


Listening to both relaxing and happy music delayed systolic blood pressure recovery when compared with both control conditions .


Listening to self-selected music is an effective mood enhancer , but it delays blood pressure recovery .


We aimed to evaluate angiotensin receptor blocker add-on therapy in patients with low cardiac output during decompensated heart failure .


We selected patients with decompensated heart failure , low cardiac output , dobutamine dependence , and an ejection fraction < 0.45 who were receiving an angiotensin-converting enzyme inhibitor .


The patients were randomized to losartan or placebo and underwent invasive hemodynamic and B-type natriuretic peptide measurements at baseline and on the seventh day after intervention .


ClinicalTrials.gov : NCT01857999 .


We studied 10 patients in the losartan group and 11 patients in the placebo group .


The patient characteristics were as follows : age 52.7 years , ejection fraction 21.3 % , dobutamine infusion 8.5 mcg/kg .


min , indexed systemic vascular resistance 1918.0 dynes.sec / cm ( 5 ) .


m ( 2 ) , cardiac index 2.8 L/min .


m ( 2 ) , and B-type natriuretic peptide 1,403 pg/mL .


After 7 days of intervention , there was a 37.4 % reduction in the B-type natriuretic peptide levels in the losartan group compared with an 11.9 % increase in the placebo group ( mean difference , -49.1 % ; 95 % confidence interval : -88.1 to -9.8 % , p = 0.018 ) .


No significant difference was observed in the hemodynamic measurements .


Short-term add-on therapy with losartan reduced B-type natriuretic peptide levels in patients hospitalized for decompensated severe heart failure and low cardiac output with inotrope dependence .


The resumption of menses is an important indicator of recovery in anorexia nervosa ( AN ) .


Patients with early-onset AN are at particularly great risk of suffering from the long-term physical and psychological consequences of persistent gonadal dysfunction .


However , the clinical variables that predict the recovery of menstrual function during weight gain in AN remain poorly understood .


The aim of this study was to investigate the impact of several clinical parameters on the resumption of menses in first-onset adolescent AN in a large , well-characterized , homogenous sample that was followed-up for 12 months .


A total of 172 female adolescent patients with first-onset AN according to DSM-IV criteria were recruited for inclusion in a randomized , multi-center , German clinical trial .


Menstrual status and clinical variables ( i.e. , premorbid body mass index ( BMI ) , age at onset , duration of illness , duration of hospital treatment , achievement of target weight at discharge , and BMI ) were assessed at the time of admission to or discharge from hospital treatment and at a 12-month follow-up .


Based on German reference data , we calculated the percentage of expected body weight ( % EBW ) , BMI percentile , and BMI standard deviation score ( BMI-SDS ) for all time points to investigate the relationship between different weight measurements and resumption of menses .


Forty-seven percent of the patients spontaneously began menstruating during the follow-up period .


% EBW at the 12-month follow-up was strongly correlated with the resumption of menses .


The absence of menarche before admission , a higher premorbid BMI , discharge below target weight , and a longer duration of hospital treatment were the most relevant prognostic factors for continued amenorrhea .


The recovery of menstrual function in adolescent patients with AN should be a major treatment goal to prevent severe long-term physical and psychological sequelae .


Patients with premenarchal onset of AN are at particular risk for protracted amenorrhea despite weight rehabilitation .


Reaching and maintaining a target weight between the 15th and 20th BMI percentile is favorable for the resumption of menses within 12 months .


Whether patients with a higher premorbid BMI may benefit from a higher target weight needs to be investigated in further studies .


Social skills training ( SST ) is a common intervention for children with autism spectrum disorders ( ASDs ) to improve their social and communication skills .


Despite the fact that SSTs are often applied in clinical practice , the evidence for the effectiveness of these trainings for children with ASD is inconclusive .


Moreover , long term outcome and generalization of learned skills are little evaluated .


Additionally , there is no research on the influence of involvement of parents and teachers on effectiveness of SST and on the generalization of learned social skills to daily life .


We expect parent and teacher involvement in SST to enhance treatment efficacy and to facilitate generalization of learned skills to daily life .


In a randomized controlled trial ( RCT ) with three conditions , 120 participants with ASD at the end of primary school ( 10-12 years of calendar age ) have been randomized to SST , SST-PTI ( SST with Parent & Teacher Involvement ) , or care-as-usual .


The SST consists of 18 group sessions of 1.5 hours for the children .


In the SST-PTI condition , parents additionally participate in 8 parent sessions and parents and teachers are actively involved in homework assignments .


Assessment takes place at three moments : before and immediately after the intervention period and at 6 months follow-up .


Primary outcome is socialization , as an aspect of adaptive functioning .


Secondary outcomes focus on specific social skills children learn during SST and on more general social skills pertaining to home and community settings from a multi-informant perspective .


Additionally , possible predictors of treatment outcome will be assessed .


The current study is an RCT study evaluating SST in a large sample of Dutch children with ASD in a specific age range ( 10-12 years ) .


Strengths of the study are the use of one manualized protocol , application of standardized and internationally used rating instruments , use of multiple raters , investigation of generalization of learned skills to daily life , and the evaluation of efficacy in the longer term by follow-up measures at 6 months after the end of training .


NTR2405 .


Immune factors determining clinical progression following HIV-1 infection remain unclear .


The SPARTAC trial randomized 366 participants in primary HIV infection ( PHI ) to different short-course therapies .


The aim of this study was to investigate how early immune responses in PHI impacted clinical progression in SPARTAC .


Participants with PHI recruited to the SPARTAC trial were sampled at enrolment , prior to commencing any therapy .


HIV-1-specific CD4 ( + ) and CD8 ( + ) ELISpot responses were measured by gamma interferon ELISPOT .


Immunological data were associated with baseline covariates and times to clinical progression using logistic regression , Kaplan-Meier plots , and Cox models .


Making a CD4 ( + ) T-cell ELISpot response ( n = 119 ) at enrolment was associated with higher CD4 ( + ) cell counts ( P = 0.02 ) and to some extent lower plasma HIV RNA ( P = 0.07 ) .


There was no correlation between the number of overlapping Gag CD8 ( + ) T-cell ELISpot responses ( n = 138 ) and plasma HIV-1 RNA viral load .


Over a median follow-up of 2.9 years , baseline CD4 ( + ) cell ELISpot responses ( n = 119 ) were associated with slower clinical progression ( P = 0.01 ; log-rank ) .


Over a median of 3.1 years , there was no evidence for a survival advantage imposed by CD8 ( + ) T-cell immunity ( P = 0.82 ) .


These data support a dominant protective role for CD4 ( + ) T-cell immunity in PHI compared with CD8 ( + ) T-cell responses , and are highly pertinent to HIV pathogenesis and vaccines , indicating that vaccine-induced CD4 ( + ) responses may confer sustained benefit .


To explore clinical effect of Bacillus Calmette-Guerin polysaccharide nucleic acid ( BCG PSN ) combined with CO ( 2 ) laser for vitiligo and its impact on Th17 cells and Th17 associated cytokines in patients with vitiligo .


The patients ( n = 102 ) with vitiligo from June 2011 to October 2013 in our hospital were randomly divided into control group ( n = 51 ) and observation group ( n = 51 ) .


Patients in the control group were treated with CO ( 2 ) laser .


Patients in the observation group were treated with BCG PSN besides CO ( 2 ) laser .


The total treatment efficacy in the two groups was appraised .


Th17 cell populations in peripheral blood were analyzed by flow cytometry .


IL-17 and IL-23 levels in peripheral blood were determined by ELISA .


The expressions of IL-17 and IL-23 mRNA in cutaneous lesion tissues were detected by real-time quantitative PCR .


Total treatment efficacy in the observation group was significantly better than that of the control group .


Compared with the control group after treatment , Th17 lymphocyte subsets in the observation group after treatment were significantly reduced in peripheral blood , the levels of serum IL-17 and IL-23 in the peripheral blood significantly dropped , and the expressions of IL-17 and IL-23 mRNA in cutaneous lesion tissues also decreased significantly .


BCG PSN combined with CO ( 2 ) laser can down-regulate Th17 lymphocyte subsets and Th17 associated cytokines in peripheral blood and cutaneous lesion .


It has a good clinical efficacy for treating vitiligo .


Prior studies have found that early HIV protease inhibitors contribute to glucose dysregulation .


Few randomized trials have evaluated glucose indices in antiretroviral-naive individuals on newer antiretroviral therapy ( ART ) .


A5224s was a substudy of A5202 , a prospective trial of 1857 ART-naive participants randomized to blinded abacavir-lamivudine ( ABC/3TC ) or tenofovir DF-emtricitabine ( TDF/FTC ) with open-label efavirenz ( EFV ) or atazanavir-ritonavir ( ATV/r ) .


Analyses used two-sample t-tests , Spearman correlation coefficients and linear regression .


A5224s included 269 nondiabetic individuals : 85 % men , 47 % white non-Hispanic , baseline median age 38 years , HIV-1 RNA 4.6 log10 copies/ml and CD4 cell count 233 cells/l .


Overall , significant 96-week increases occurred in fasting glucose , insulin and the homeostatic model assessment of insulin resistance ( HOMA-IR ) , P 0.004 .


Assignment to EFV ( versus ATV/r ) resulted in significantly greater glucose increase [ mean difference 4.4 ; 95 % confidence interval ( CI ) 1.3 , 7.5 mg/dl ; P = 0.006 ] but not insulin or HOMA-IR ( P 0.72 ) .


Glucose indices were not significantly different between ABC/3TC and TDF/FTC arms , P 0.18 .


Significant correlations were detected between changes in glucose indices and changes in BMI ; all r 0.23 , P 0.001 .


In multivariable analyses , in addition to the EFV effect , higher baseline HIV-1 RNA and greater BMI change were significant independent factors associated with greater glucose increase .


Changes in glucose metabolism were not significantly different between TDF/FTC and ABC/3TC-based regimens .


A small but significantly greater increase in glucose was observed in those assigned to EFV .


As glucose dysregulation may increase with time on ART , longer term studies will be needed to further clarify the clinical significance of these findings .


The aim of this prospective single-blinded study was to analyze the stone-free ( SF ) rates between pneumatic lithotripsy ( PL ) and laser lithotripsy ( LL ) for the treatment of single and primary ureteral stones and to evaluate potentially predictive factors of a SF status .


From January 2010 to January 2011 , 133 consecutive patients with single and primary ureteral stones were prospectively enrolled .


Uni - and multivariate logistic regression were performed to estimate predictive factors of a SF status .


The SF rate in the PL group was 80.7 and 86.1 % in the LL group ( p = 0.002 ) .


Success rates with regard of stone position were not significantly different between groups .


At univariate logistic regression , middle ureteral stone ( OR 3.33 , p = 0.04 ) , distal ureteral stone ( OR 4.4 , p = 0.02 ) , LL ( OR 3.05 , p = 0.04 ) and Hounsfield units ( HUs ) ( OR 1.07 , p = 0.03 ) were significantly predictive factors of a SF status .


At a multivariate logistic regression , middle ureteral stone ( OR 5.58 , p = 0.01 ) , distal ureteral stone ( OR 7.87 , p < 0.01 ) , LL ( OR 2.4 , p = 0.02 ) and HUs 1,200 ( OR 1.15 , p = 0.02 ) were significantly associated with a SF status .


LL significantly influences the SF status after ureteroscopy , allowing a higher SF rate when compared to PL .


HUs may significantly influence this success rate .


Anxiety in children is common and incapacitating and increases the risk of mental health disorders in adulthood .


Although effective interventions are available , few children are identified and referred for specialist treatment .


Alternative approaches in which prevention programmes are delivered in school appear promising .


However , comparatively little is known about the best intervention leader ( health care-led vs. school-led ) , long-term effects or the primary preventive value of such programmes .


Preventing Anxiety in Children through Education in Schools , or PACES , is a pragmatic cluster randomised controlled trial evaluating the effectiveness of a cognitive-behavioural therapy prevention programme ( FRIENDS ) on symptoms of anxiety and low mood in 9 - to 10-year-old children .


Forty-one schools were randomly assigned to one of three conditions : school-led FRIENDS , health care-led FRIENDS or treatment as usual .


Assessments were undertaken at baseline , 6 months and 12 months , with the primary outcome measure being the Revised Child Anxiety and Depression Scale score at 12 months .


Secondary outcome measures are changes in self-esteem , worries , bullying and life satisfaction .


This protocol summarises the procedure for the 24-month follow-up of this cohort .


The study will determine the medium-term effectiveness of an anxiety prevention programme delivered in schools .


ISRCTN23563048 .


There is emerging consensus that enhanced inter-professional teamwork is necessary for the effective and efficient delivery of primary care , but there is less practical information specific to primary care available to guide practices on how to better work as teams .


The purpose of this study was to describe how primary care practices have overcome challenges to providing team-based primary care and the implications for care delivery and policy .


Practices for this qualitative study were selected from those recognized as patient-centered medical homes ( PCMHs ) via the most recent National Committee for Quality Assurance PCMH tool , which included a domain on practice teamwork .


Sixty-three respondents , ranging from physicians to front-desk staff , were interviewed from May through December of 2013 .


Practice respondents came from 27 primary care practices ranging in size , type , geography , and population served .


Practices emphasizing teamwork overcame common challenges through the incremental delegation of non-clinical tasks away from physicians .


The roles of medical assistants and nurses are expanding to include template-guided information collection from patients prior to the physician office visit as well as many other tasks .


The inclusion of staff input in care workflow redesign and the use of data to demonstrate how team care process changes improved patient care were helpful in gaining staff buy-in .


Team `` huddles '' guided by pre-visit planning were reported to assist in role delegation , consistency of information collected from patients , and structured communication among team members .


Nurse care managers were found to be important team members in working with patients and their physicians on care plan design and execution .


Most practices had not participated in formal teamwork training , but respondents expressed a desire for training for key team members , particularly if they could access it on-site ( e.g. , via practice coaches or the Internet ) .


Participants who adopted new forms of delegation and care processes using teamwork approaches , and who were supported with resources , system support , and data feedback , reported improved provider satisfaction and productivity .


There appears to be a need for more on-site teamwork training .


The effect of metformin on weight reduction in polycystic ovary syndrome ( PCOS ) is often unsatisfactory .


In this study , we investigated the potential add-on effect of treatment with the glucagon-like peptide-1 receptor agonist liraglutide on weight loss in obese nondiabetic women with PCOS who had lost < 5 % body weight during pretreatment with metformin .


A total of 40 obese women with PCOS , who had been pretreated with metformin for at least 6 months , participated in a 12-week open-label , prospective study .


They were randomized to one of three treatment arms : metformin ( MET ) arm 1000 mg BID , liraglutide ( LIRA ) arm 1.2 mg QD s.c. , or combined MET 1000 mg BID and LIRA ( COMBI ) 1.2 mg QD s.c. Lifestyle intervention was not actively promoted .


The primary outcome was change in body weight .


Thirty six patients ( aged 31.3 7.1 years , BMI 37.1 4.6 kg/m ) completed the study : 14 on MET , 11 on LIRA , and 11 on combined treatment .


COMBI therapy was superior to LIRA and MET monotherapy in reducing weight , BMI , and waist circumference .


Subjects treated with COMBI lost on average 6.5 2.8 kg compared with a 3.8 3.7 kg loss in the LIRA group and a 1.2 1.4 kg loss in the MET group ( P < 0.001 ) .


The extent of weight loss was stratified : a total of 38 % of subjects were high responders who lost 5 % body weight , 22 % of them in the COMBI arm compared with 16 and 0 % in the LIRA and MET arm respectively .


BMI decreased by 2.4 1.0 in the COMBI arm compared with 1.3 1.3 in LIRA and 0.5 0.5 in the MET arm ( P < 0.001 ) .


Waist circumference also decreased by 5.5 3.8 cm in the COMBI arm compared with 3.2 2.9 cm in LIRA and 1.6 2.9 cm in the MET arm ( P = 0.029 ) .


Subjects treated with liraglutide experienced more nausea than those treated with metformin , but severity of nausea decreased over time and did not correlate with weight loss .


Short-term combined treatment with liraglutide and metformin was associated with significant weight loss and decrease in waist circumference in obese women with PCOS who had previously been poor responders regarding weight reduction on metformin monotherapy .


Probiotics may help resolve bowel symptoms and improve quality of life .


We investigated the effects of 12 weeks of probiotics administration in colorectal cancer patients .


We conducted a double-blind , randomized , placebo-controlled trial .


The participants took probiotics ( Lacidofil ) or placebo twice a day for 12 weeks .


The cancer-related quality of life ( FACT ) , patient 's health-9 ( PHQ-9 ) , and bowel symptom questionnaires were completed by each participant .


We obtained data for 32 participants in the placebo group and 28 participants in the probiotics group .


The mean ages of total participants were 56.18 .86 years and 58.3 % were male .


Administration of probiotics significantly decreased the proportion of patients suffering from irritable bowel symptoms ( 0 week vs. 12 week ; 67.9 % vs. 45.7 % , p = 0.03 ) , improved colorectal cancer-related FACT ( baseline vs. 12 weeks : 19.79 4.66 vs. 21.18 3.67 , p = 0.04 ) and fatigue-related FACT ( baseline vs. 12 weeks : 43.00 ( 36.50-45 .50 ) vs. 44.50 ( 38.50-49 .00 ) , p = 0.02 ) and PHQ-9 scores ( 0 weeks vs. 12 weeks ; 3.00 ( 0-8 .00 ) vs. 1.00 ( 0-3 .00 ) , p = 0.01 ) .


We found significant differences in changes of the proportion of patients with bowel symptoms ( p < 0.05 ) , functional well-being scores ( p = 0.04 ) and cancer-related FACT scores ( p = 0.04 ) between the two groups .


Probiotics improved bowel symptoms and quality of life in colorectal cancer survivors .


To describe Action Schools !


BC ( AS !


BC ) from efficacy to scale-up .


Education and health system stakeholders and children in grades 4-6 from elementary schools in British Columbia , Canada .


At the provincial level , the AS !


BC model reflected socioecological theory and a partnership approach to social change .


Knowledge translation and exchange were embedded as a foundational element .


At the school level , AS !


BC is a comprehensive school health-based model providing teachers and schools with training and resources to integrate physical activity ( PA ) and healthy eating ( HE ) into the school environment .


Our research team partnered with key community and government stakeholders to deliver and evaluate AS !


BC over efficacy , effectiveness and implementation trials .


On the basis of significant increases in PA , cardiovascular fitness , bone and HE in AS !


BC schools during efficacy trials , the BC government supported a provincial scale-up .


Since its inception , the AS !


BC Support Team and > 225 trained regional trainers have delivered 4677 teacher-focused workshops ( training approximately 81,000 teachers ) , reaching approximately 500,000 students .


After scale-up , PA delivery was replicated but the magnitude of change appeared less .


One ( HE ) and 4 ( PA ) years after scale-up , trained AS !


BC teachers provided more PA and HE opportunities for students even in the context of supportive provincial policies .


Whole school models like AS !


BC can enhance children 's PA and health when implemented in partnership with key stakeholders .


At the school level , adequately trained and resourced teachers and supportive school policies promoted successful scale-up and sustained implementation .


At the provincial level , multisectoral partnerships and embedded knowledge exchange mechanisms influenced the context for action at the provincial and school level , and were core elements of successful implementation .


Clinical Trials Registry NCT01412203 .


Although resistance training adaptations in multiple sclerosis ( MS ) patients have been described , the detraining response in this population is largely unknown .


[ corrected ] This study was designed to evaluate the effects of a 12-week detraining period on muscle strength ( isometric and endurance ) and muscle power of multiple sclerosis ( MS ) patients that had previously carried out a 12-week resistance training program ( RTP ) .


Forty-two MS patients were randomly assigned into two groups : an exercise group ( EG ) that performed a 12-week RTP for the knee extensors muscles ; and a control group ( CG ) , that did not perform any specific training .


Knee extension maximal voluntary isometric contraction ( MVIC ) , muscle power and muscle endurance were evaluated before and after the RTP , as well as 12 weeks after training completion .


A strain gauge was used to measure the maximal voluntary isometric contraction and muscle power was assessed with a linear encoder .


Muscle endurance was interpreted as the number of repetitions that a patient could perform in a single set of knee extension exercise .


The EG increased MVIC and muscle power after the training period , although the training did not affect muscle endurance .


After 12 weeks of detraining , MVIC returned to pre-training values but muscle power was still greater than pre-training values in the EG .


The CG did not present any change in the variables measured during the intervention .


A 12-week RTP improved MVIC and muscle power in MS patients .


Additionally , 12 weeks of detraining blunted strength training adaptations in MS patients , although muscle power training adaptations were still evident after the detraining period .


Central neurological injury ( CNI ) is a major contributor to physical disability that affects both adults and children all over the world .


The main sequelae of chronic stage CNI are spasticity , paresis of specific muscles , and poor selective motor control .


Here , we apply the concept of contralateral peripheral neurotization in spasticity releasing and motor function restoration of the affected upper extremity .


A clinical investigation was performed to verify the clinical efficacy of contralateral C7 neurotization for rescuing the affected upper extremity after CNI .


In the present study , 6 adult hemiplegia patients received the nerve transfer surgery of contralateral C7 to C7 of the affected side .


Another 6 patients with matched pathological and demographic status were assigned to the control group that received rehabilitation only .


During the 2-year follow-up , muscle strength of bilateral upper extremities was assessed .


The Modified Ashworth Scale and Fugl-Meyer Assessment Scale were used for evaluating spasticity and functional use of the affected upper extremity , respectively .


Both flexor spasticity release and motor functional improvements were observed in the affected upper extremity in all 6 patients who had surgery .


The muscle strength of the extensor muscles and the motor control of the affected upper extremity improved significantly .


There was no permanent loss of sensorimotor function of the unaffected upper extremity .


This contralateral C7 neurotization approach may open a door to promote functional recovery of upper extremity paralysis after CNI .


To assess the safety and the possible advantages of early ( 1-wk ) cochlear implant switch-on in children and to compare impedance and ECAP threshold changes between subjects undergoing early switch-on and those undergoing traditional , 1-month switch-on .


Prospective cohort study .


Tertiary care referral pediatric center .


Seventeen children receiving a unilateral or bilateral Nucleus Freedom cochlear implant were included , for a total of 20 ears .


Ten ears were assigned to the early ( 1-wk ) switch-on group and 10 to the control group ( switch-on after 4 wks ) .


Common ground impedance values and electrically evoked compound action potential thresholds were measured from intraoperation until 9 months postoperatively .


Speech perception improvements over time were also assessed .


Complication rate , impedance levels ( k ) , and electrically evoked compound action potentials ( current levels )


Early switch-on was well tolerated by patients and did not cause complications .


Impedances dropped significantly after switch-on in both groups .


They also seemed to achieve an earlier stability in the early switch-on patients , although the difference between groups was not significant .


ECAP thresholds showed a similar , nonsignificant decreasing trend over time in both groups .


Speech perception improvements did not differ between groups .


This is the first study investigating the safety and the effects of an early cochlear implant switch-on in children .


Results show that such a procedure is well tolerated by pediatric subjects and free from complications .


Impedance measurements suggest that the earlier switched-on subjects benefit of lower and more stable impedances than subjects undergoing 1-month switch-on .


The electronic self report assessment - cancer ( ESRA-C ) , has been shown to reduce symptom distress during cancer therapy The purpose of this analysis was to evaluate aspects of how the ESRA-C intervention may have resulted in lower symptom distress ( SD ) .


Patients at two cancer centers were randomized to ESRA-C assessment only ( control ) or the Web-based ESRA-C intervention delivered to patients ' homes or to a tablet in clinic .


The intervention allowed patients to self-monitor symptom and quality of life ( SxQOL ) between visits , receive self-care education and coaching to report SxQOL to clinicians .


Summaries of assessments were delivered to clinicians in both groups .


Audio-recordings of clinic visits made 6 weeks after treatment initiation were coded for discussions of 26 SxQOL issues , focusing on patients ' / caregivers ' coached verbal reports of SxQOL severity , pattern , alleviating/aggravating factors and requests for help .


Among issues identified as problematic , two measures were defined for each patient : the percent SxQOL reported that included a coached statement , and an index of verbalized coached statements per SxQOL .


The Wilcoxon rank test was used to compare measures between groups .


Clinician responses to problematic SxQOL were compared .


A mediation analysis was conducted , exploring the effect of verbal reports on SD outcomes .


517 ( 256 intervention ) clinic visits were audio-recorded .


General discussion of problematic SxQOL was similar in both groups .


Control group patients reported a median 75 % of problematic SxQOL using any specific coached statement compared to a median 85 % in the intervention group ( p = .0009 ) .


The median report index of coached statements was 0.25 for the control group and 0.31 for the intervention group ( p = 0.008 ) .


Fatigue , pain and physical function issues were reported significantly more often in the intervention group ( all p < .05 ) .


Clinicians ' verbalized responses did not differ between groups .


Patients ' verbal reports did not mediate final SD outcomes ( p = .41 ) .


Adding electronically-delivered , self-care instructions and communication coaching to ESRA-C promoted specific patient descriptions of problematic SxQOL issues compared with ESRA-C assessment alone .


However , clinician verbal responses were no different and subsequent symptom distress group differences were not mediated by the patients ' reports .


NCT00852852 ; 26 Feb 2009 .


Endothelial progenitor cells ( EPC ) are bone marrow-derived cells which can undergo differentiation into endothelial cells and participate in endothelial repair and angiogenesis .


Insulin facilitates this in vitro mediated by the IGF-1 receptor .


Clinical trials showed that the number of circulating EPCs is influenced by glucose control and EPC are a predictor of cardiovascular death .


To study direct effects of insulin treatment on EPCs in type 2 diabetes patients , add-on basal insulin treatment was compared to an escalation of oral medication aiming at similar glucose control between the groups .


55 patients with type 2 diabetes ( 61.65.9 years ) on oral diabetes medication were randomized in a 2:2:1 ratio in 3 groups .


Patients were treated additionally with insulin glargine ( n = 20 ) , NPH insulin ( n = 22 ) or escalated with oral medication ( n = 13 ) .


Number of circulating EPC , EPC-outgrowth , intima media thickness , skin microvascular function and HbA1c were documented at baseline and/or after 4 weeks and 4 months .


HbA1c at baseline was , 7.3 + / -0.7 % in the oral group , 7.3 + / -0.9 % and 7.5 + / -0.7 % in the glargine and NPH insulin respectively ( p = 0.713 ) .


HbA1c after 4 months decreased to 6.8 + / -0.8 % , 6.6 + / -0.7 % and 6.7 + / -0.6 % , in the oral , glargine and NPH insulin group respectively ( p = 0.61 ) .


FACS analysis showed no difference in number of circulating EPC between the groups after 4 weeks and 4 months .


However , the outgrowth of EPCs as detected by colony forming assay was increased in the NPH insulin and glargine groups ( 29.2 + / -6.4 and 29.4 + / - 6.7 units respectively ) compared to the group on oral medication ( 23.2 + / -6.3 , p = 0.013 ) after 4 months of treatment .


A significant decrease of IMT from 0.80 mm ( + / -0.14 ) at baseline to 0.76 mm ( + / -0.12 ) after 4 months could be observed in all patients only ( p = 0.03 ) with a trend towards a reduction of IMT after 4 months when all patients on insulin treatment were compared to the oral treatment group ( p = 0.06 ) .


Skin microvascular function revealed no differences between the groups ( p = 0.74 ) .


The study shows that a 4-month treatment with add-on insulin significantly increases the outgrowth of EPC in patients with type 2 diabetes mellitus .


( Clinical Trials Identifier : NCT00523393 ) .


There is an increasing need for new treatments for patients with Crohn 's disease ( CD ) in whom previous therapy with tumor necrosis factor ( TNF ) antagonists has failed .


We performed a placebo-controlled , phase 3 , double-blind trial to evaluate the efficacy and safety of vedolizumab , an antibody against the integrin 47 , as induction therapy .


Patients with moderately to severely active CD ( CD activity index [ CDAI ] score , 220-400 points ) were assigned randomly to groups given vedolizumab ( 300 mg ) or placebo intravenously at weeks 0 , 2 , and 6 .


The primary analysis involved 315 patients with previous TNF antagonist failure ( ie , an inadequate response to , loss of response to , or intolerance of 1 TNF antagonists ) ; we determined the proportion of patients in clinical remission ( CDAI , 150 points ) at week 6 .


Secondary analyses evaluated outcomes at weeks 6 and 10 in this population and in the overall population ( N = 416 ) , which included patients naive to TNF antagonist therapy ( n = 101 ) .


Among patients who had experienced previous TNF antagonist failure , 15.2 % of those given vedolizumab and 12.1 % of those given placebo were in remission at week 6 ( P = .433 ) .


At week 10 , a higher proportion of this population given vedolizumab was in remission ( 26.6 % ) than those given placebo ( 12.1 % ) ( nominal P = .001 ; relative risk , 2.2 ; 95 % confidence interval , 1.3-3 .6 ) .


A higher proportion of patients with previous TNF antagonist failure given vedolizumab also had a CDAI-100 response ( 100-point decrease in CDAI score from baseline ) at week 6 than those given placebo ( 39.2 % vs 22.3 % ; nominal P = .001 ; relative risk , 1.8 ; 95 % confidence interval , 1.2-2 .5 ) .


Adverse event results were similar among all groups .


Vedolizumab was not more effective than placebo in inducing clinical remission at week 6 among patients with CD in whom previous treatment with TNF antagonists had failed .


The therapeutic benefits of vedolizumab in these patients were detectable at week 10 .


ClinicalTrials.gov number : NCT01224171 .


Proper caloric intake goals in critically ill surgical patients are unclear .


It is possible that overnutrition can lead to hyperglycemia and an increased risk of infection .


This study was conducted to determine whether surgical infection outcomes in the intensive care unit ( ICU ) could be improved with the use of hypocaloric nutritional support .


Eighty-three critically ill patients were randomly allocated to receive either the standard calculated daily caloric requirement of 25-30 kcal kg ( -1 ) d ( -1 ) ( eucaloric ) or 50 % of that value ( hypocaloric ) via enteral tube feeds or parenteral nutrition , with an equal protein allocation in each group ( 1.5 g kg ( -1 ) d ( -1 ) ) .


There were 82 infections in the hypocaloric group and 66 in the eucaloric group , with no significant difference in the mean ( SE ) number of infections per patient ( 2.0 0.6 and 1.6 0.2 , respectively ; P = 0.50 ) , percentage of patients acquiring infection [ 70.7 % ( 29 of 41 ) and 76.2 % ( 32 of 42 ) , respectively ; P = 0.57 ] , mean ICU length of stay ( 16.7 2.7 and 13.5 1.1 d , respectively ; P = 0.28 ) , mean hospital length of stay ( 35.2 4.9 and 31.0 2.5 d , respectively ; P = 0.45 ) , mean 0600 glucose concentration ( 132 2.9 and 135 3.1 mg/dL , respectively ; P = 0.63 ) , or number of mortalities [ 3 ( 7.3 % ) and 4 ( 9.5 % ) , respectively ; P = 0.72 ] .


Further analyses revealed no differences when analyzed by sex , admission diagnosis , site of infection , or causative organism .


Among critically ill surgical patients , caloric provision across a wide acceptable range does not appear to be associated with major outcomes , including infectious complications .


The optimum target for caloric provision remains elusive .


Curry , one of the most popular foods in Japan , contains spices that are rich in potentially antioxidative compounds , such as curcumin and eugenol .


Oxidative stress is thought to impair endothelial function associated with atherosclerosis , a leading cause of cardiovascular events .


The aim of this study was to determine whether a single consumption of curry meal would improve endothelial function in healthy men .


Fourteen healthy male subjects ( BMI 23.72.7 kg/m2 ; age 459years ) were given a single serving of curry meal or spice-free control meal ( 180g of curry or control and 200g of cooked rice ; approximately 500kcal in total ) in a randomized , controlled crossover design .


Before and 1hr after the consumption , fasting and postprandial flow-mediated vasodilation ( FMD ) responses and other parameters were measured .


The consumption of the control meal decreased FMD from 5.82.4 % to 5.12.3 % ( P = 0.039 ) .


On the other hand , the consumption of the curry meal increased FMD from 5.22.5 % to 6.62.0 % ( P = 0.001 ) , and the postprandial FMD after the curry meal was higher than that after the control meal ( P = 0.002 ) .


Presence of spices in the curry did not alter significantly the systemic and forearm hemodynamics , or any biochemical parameters including oxidative stress markers measured .


These findings suggest that the consumption of curry ameliorates postprandial endothelial function in healthy male subjects and may be beneficial for improving cardiovascular health .


UMIN Clinical Trials Registry 000012012 .


This study 's purpose was to investigate the effect of a glass ionomer cement as a liner over infected unexcavated dentin after 60 days and at 10 to 15 months .


Forty-five permanent molars with deep carious lesions were selected .


Fragments of carious dentin were removed prior to lining the cavity ( baseline sample ) with glass ionomer cement ( G1 ) or an inert wax material ( G2 ) .


Cavities were restored with composite resin and reopened 60 days later , when other fragments were removed ( 60-day sample ) .


The dentin morphology ( scanning electron microscopy ) and mineral content of calcium , phosphorus , and fluorine were assessed .


During the follow-up periods ( 60 days and 10 to 15 months ) , restorations were evaluated and standardized radiographs were taken .


A postprocessing routine was used to identify changes in the radiographic density between periods .


After 60 days , the dentin exhibited a better organization , fewer bacteria , and signs of remineralization .


The weight percents of calcium and phosphorus were higher 60 days after the cavity sealing , regardless of the group .


Higher gray levels of carious and sound dentin were seen on the 10 - to 15-month radiographs , irrespective of the group .


The success rates of G1 and G2 were 89 percent and 88 percent , respectively .


The lining material is n't fundamental for caries arrestment .


Early ( 60-day ) and late ( 10 to 15 months ) dentin changes occurred , indicating the remineralization of dentin carious tissue .


There is a lack of evidence on the best treatment option for umbilical granuloma .


The primary aim of this study was to compare three treatments for umbilical granuloma : standard treatment with topical silver nitrate , clobetasol propionate cream ( 0.05 % ) and ethanol wipes .


The secondary aim was to evaluate whether the treatment could be successfully administered by a parent at home , rather than in the outpatient clinic .


A total of 109 infants were randomised to one of three groups and 94 infants completed the assigned treatment : 30 infants received standard treatment with silver nitrate ( 99 % ) in the outpatient clinic , 30 infants had topical clobetasol propionate cream ( 0.05 % ) applied at home , and 34 infants received cleansing with ethanol wipes ( 82 % ) at home .


Silver nitrate and clobetasol propionate cream ( 0.05 % ) were significantly superior to ethanol wipes , with shorter healing times and higher resolution rates ( p = 0.0001 ) .


Healing time and resolution rates were identical for silver nitrate and clobetasol propionate cream ( 0.05 % ) .


Mild side effects were occasionally reported , all of which were self-limiting .


Treating umbilical granuloma with topical clobetasol propionate cream ( 0.05 % ) at home is as effective as treating it with topical silver nitrate ( 99 % ) in the clinic .


The purpose of this study was to evaluate the diagnostic performance and interobserver agreement of 2-dimensional ( 2D ) and 3-dimensional ( 3D ) sonography for evaluating extrathyroidal extension of papillary thyroid carcinoma .


A total of 79 papillary thyroid carcinomas in 79 patients who underwent both 2D and 3D sonography for preoperative staging of papillary thyroid carcinoma were included .


When the lesion was abutting on the thyroid capsule on 2D sonography , 3D sonography was performed .


Three radiologists reviewed 3 data sets : 2D sonography , 3D sonography , and a combined set of both for tumor staging .


The diagnostic performance , including sensitivity , specificity , positive predictive value , negative predictive value , and accuracy , for extrathyroidal extension was analyzed .


Interobserver agreement of the 3 radiologists was assessed with values .


The overall accuracy rates for 2D sonography , 3D sonography , and the combined set in predicting extrathyroidal extension were 60.8 % , 66.2 % , and 67.9 % , respectively .


The accuracy of the combined set was significantly higher than that of 2D sonography ( P = .016 ) .


The interobserver agreement of the 3 reviewers was fair ( = 0.33 ) for 2D sonography and moderate for 3D sonography ( = 0.46 ) and the combined set ( = 0.49 ) .


Adding 3D sonography to 2D sonography could improve the accuracy and interobserver agreement for predicting extrathyroidal extension of papillary thyroid carcinoma .


To compare corifollitropin alfa with recombinant FSH treatment in terms of the vital pregnancy rate in older patients undergoing IVF .


Phase 3 randomized , double-blind , noninferiority trial .


Multicenter trial .


A total of 1,390 women aged 35-42 years .


A single injection of 150 g of corifollitropin alfa or daily 300 IU of recombinant FSH for the first 7 days then daily recombinant FSH until three follicles reach 17 mm in size .


Ganirelix was started on stimulation day 5 up to and including the day of recombinant hCG administration .


If available , two good quality embryos were transferred on day 3 .


Vital pregnancy rate ( PR ) , number of oocytes , and live birth rate .


Vital PRs per started cycle were 23.9 % in the corifollitropin alfa group and 26.9 % in the recombinant FSH group , with an estimated difference ( 95 % confidence interval ) of -3.0 % ( -7.4 to 1.4 ) .


The mean ( SD ) number of recovered oocytes per started cycle was 10.7 ( 7.2 ) and 10.3 ( 6.8 ) in the corifollitropin alfa and the recombinant FSH groups , respectively , with an estimated difference of 0.5 ( -0.2 to 1.2 ) .


The live birth rates per started cycle were 21.3 % in the corifollitropin alfa group and 23.4 % in the recombinant FSH group , with an estimated difference ( 95 % confidence interval ) -2.3 % ( -6.5 to 1.9 ) .


The incidence of serious adverse events was 0.4 % versus 2.7 % in the corifollitropin alfa and recombinant FSH groups , respectively , and of ovarian hyperstimulation syndrome ( OHSS ; all grades ) was 1.7 % in both groups .


Treatment with corifollitropin alfa was proven noninferior to daily recombinant FSH with respect to vital PRs , number of oocytes retrieved , and live birth rates , and was generally well tolerated .


NCT01144416 .


Recent reviews suggest Web-based interventions are promising approaches for weight management but they identify difficulties with suboptimal usage .


The literature suggests that offering some degree of human support to website users may boost usage and outcomes .


We disseminated the POWeR ( `` Positive Online Weight Reduction '' ) Web-based weight management intervention in a community setting .


POWeR consisted of weekly online sessions that emphasized self-monitoring , goal-setting , and cognitive/behavioral strategies .


Our primary outcome was intervention usage and we investigated whether this was enhanced by the addition of brief telephone coaching .


We also explored group differences in short-term self-reported weight loss .


Participants were recruited using a range of methods including targeted mailouts , advertisements in the local press , notices on organizational websites , and social media .


A total of 786 adults were randomized at an individual level through an online procedure to ( 1 ) POWeR only ( n = 264 ) , ( 2 ) POWeR plus coaching ( n = 247 ) , or ( 3 ) a waiting list control group ( n = 275 ) .


Those in the POWeR plus coaching arm were contacted at approximately 7 and 28 days after randomization for short coaching telephone calls aimed at promoting continued usage of the website .


Website usage was tracked automatically .


Weight was assessed by online self-report .


Of the 511 participants allocated to the two intervention groups , the median number of POWeR sessions completed was just one ( IQR 0-2 for POWeR only , IQR 0-3 for POWeR plus coach ) .


Nonetheless , a substantial minority completed at least the core three sessions of POWeR : 47 participants ( 17.8 % , 47/264 ) in the POWeR-only arm and 64 participants ( 25.9 % , 64/247 ) in the POWeR plus coaching arm .


Participants in the POWeR plus coaching group persisted with the intervention for longer and were 1.61 times more likely to complete the core three sessions than the POWeR-only group ( ( 2 ) 1 = 4.93 ; OR 1.61 , 95 % CI 1.06-2 .47 ; n = 511 ) .


An intention-to-treat analysis showed between-group differences in weight loss ( F2 ,782 = 12.421 , P < .001 ) .


Both intervention groups reported more weight loss than the waiting list control group .


Weight loss was slightly , but not significantly , greater in the POWeR plus coaching group .


A large proportion of participants assigned to POWeR plus coaching refused phone calls or were not contactable ( 57.9 % , 143/247 ) .


Exploratory analyses identified health and sociodemographic differences between those who did and did not engage in coaching when it was made available to them .


Users who engaged with coaching used the intervention more and lost more weight than those who did not .


In common with most Web-based intervention studies , usage of POWeR was suboptimal overall .


However , our findings suggest that supplementing Web-based weight management with brief human support could improve usage and outcomes in those who take it up .


International Standard Randomized Controlled Trial Number ( ISRCTN ) : 98176068 ; http://www.controlled-trials.com/ISRCTN98176068 ( Archived by WebCite at http://www.webcitation.org/6OKRjM2oy ) .


Patients with Addison 's disease ( AD ) report impaired subjective health status ( SHS ) .


Since cortisol exhibits a robust circadian cycle that entrains other biological clocks , impaired SHS may be due to the noncircadian cortisol profile achieved with conventional glucocorticoid replacement .


Continuous subcutaneous hydrocortisone infusion ( CSHI ) reproduces a circadian cortisol profile , but its effects on SHS have not been objectively evaluated .


The aim of this study was to determine the effect of CSHI on SHS in AD .


This was a multicentre , double-blind , placebo-controlled trial of CSHI vs oral glucocorticoid therapy .


Participants received in random order 4 weeks of : CSHI and oral placebo , and subcutaneous placebo and oral hydrocortisone , separated by a 2-week washout period .


SHS was assessed using the Short-Form 36 ( SF-36 ) , General Health Questionnaire ( GHQ-28 ) , Fatigue Scale ( FS ) , Gastrointestinal Symptom Rating Scale ( GSRS ) ; and Addison 's Quality of Life Questionnaire ( AddiQoL ) .


Participants were asked their ( blinded ) treatment preference .


Twenty-four hour urine free cortisol ( UFC ) and diurnal salivary cortisol collections compared cortisol exposure during each treatment .


Ten participants completed the study .


Baseline SHS scores ( mean SE ) were consistent with mild impairment : SF-36 physical component summary 48.4 ( 2.4 ) , mental component summary 53.3 ( 3.0 ) ; GHQ-28 18.1 ( 3.3 ) ; GSRS 3.7 ( 1.6 ) , and AddiQoL 94.7 ( 3.7 ) .


FS was similar to other AD cohorts 13.5 ( 1.0 ) ( P = 0.82 ) .


UFC between treatments was not different ( P = 0.87 ) .


The salivary cortisol at 0800 h was higher during CSHI ( P = 0.03 ) , but not at any other time points measured .


There was no difference between the treatments in the SHS assessments .


Five participants preferred CSHI , four oral hydrocortisone , and one was uncertain .


Biochemical measurements indicate similar cortisol exposure during each treatment period , although a more circadian pattern was evident during CSHI .


CSHI does not improve SHS in AD with good baseline SHS .


This casts some doubt on the potential benefit of circadian cortisol delivery on SHS in AD .


To evaluate the role of bladder training during postoperative hospital stay in patients submitted to nerve-sparing radical hysterectomy , and to identify any clinical or surgical factor associated with postoperative bladder dysfunction .


Parallel group randomized single institution trial , on gynaecologic malignancies patients conducted in Catholic University of Sacred Heart Rome , between April 2009 and November 2011 .


Randomization was on 1:1 , using a block randomized computer-generated list .


Patients underwent Querleu-Morrow type B2 or C1 radical hysterectomy .


After 2 days from surgery , patients were randomized to perform or not bladder training ( scheduled clamping and unclamping of the trans-urethral catheter every three hours ) .


Main outcome measures Necessity and duration of clean intermittent self catheterization .


Randomized participants were 111 women ( bladder training arm n = 55 ; control arm n = 56 ) .


A total of 22 women ( 19.8 % ) required clean intermittent self catheterization , equally distributed in the two arms .


At univariate analysis , only the type of radical hysterectomy was significantly associated with need of clean intermittent self catheterization ( type C1 vs. type B2 ; p = 0.013 ) .


At univariate analysis , duration of clean intermittent self-catheterization was not associated with age , BMI , type of hysterectomy and of neo-adjuvant treatment .


Functional bladder disfunctions are the most common long-term complications following radical hysterectomy .


Systematic postoperative bladder training following nerve-sparing radical hysterectomy does not influence the rate of urinary retention or re-admission for bladder catheterization .


To evaluate the efficacy and safety of empagliflozin/linagliptin in subjects with type 2 diabetes .


Subjects not receiving antidiabetes therapy for 12 weeks were randomized to empagliflozin 25 mg/linagliptin 5 mg ( n = 137 ) , empagliflozin 10 mg/linagliptin 5 mg ( n = 136 ) , empagliflozin 25 mg ( n = 135 ) , empagliflozin 10 mg ( n = 134 ) , or linagliptin 5 mg ( n = 135 ) for 52 weeks .


The primary end point was change from baseline in HbA1c at week 24 .


Mean HbA1c at baseline was 7.99-8 .05 % ( 64 mmol/mol ) .


At week 24 , adjusted mean ( SE ) changes from baseline in HbA1c with empagliflozin 25 mg/linagliptin 5 mg , empagliflozin 10 mg/linagliptin 5 mg , empagliflozin 25 mg , empagliflozin 10 mg , and linagliptin 5 mg were -1.08 ( 0.06 ) % ( -11.8 [ 0.7 ] mmol/mol ) , -1.24 ( 0.06 ) % ( -13.6 [ 0.7 ] mmol/mol ) , -0.95 ( 0.06 ) % ( -10.4 [ 0.7 ] mmol/mol ) , -0.83 ( 0.06 ) % ( -9.1 [ 0.7 ] mmol/mol ) , and -0.67 ( 0.06 ) % ( -7.3 [ 0.7 ] mmol/mol ) , respectively .


Reductions in HbA1c were significantly greater for empagliflozin 25 mg/linagliptin 5 mg compared with linagliptin 5 mg ( P < 0.001 ) but not compared with empagliflozin 25 mg and were significantly greater for empagliflozin 10 mg/linagliptin 5 mg compared with the individual components ( P < 0.001 for both ) .


At week 24 , 55.4 % , 62.3 % , 41.5 % , 38.8 % , and 32.3 % of subjects with baseline HbA1c 7 % ( 53 mmol/mol ) reached HbA1c < 7 % with empagliflozin 25 mg/linagliptin 5 mg , empagliflozin 10 mg/linagliptin 5 mg , empagliflozin 25 mg , empagliflozin 10 mg , and linagliptin 5 mg , respectively .


Efficacy was maintained at week 52 .


The proportion of subjects with adverse events ( AEs ) over 52 weeks was similar across groups ( 68.9-81 .5 % ) , with no confirmed hypoglycemic AEs .


Reductions from baseline in HbA1c with empagliflozin/linagliptin were significantly different versus linagliptin and empagliflozin 10 mg but not versus empagliflozin 25 mg .


Empagliflozin/linagliptin was well tolerated .


The aims of this study were to test the hypothesis that people with stroke who receive formal powered wheelchair skills training improve their wheelchair skills to a significantly greater extent than participants in a control group who do not and to explore the influence of spatial neglect .


Seventeen participants with stroke ( including nine with spatial neglect ) were randomly allocated to intervention ( n = 9 ) or control ( n = 8 ) groups .


Those in the intervention group received up to five 30-min training sessions based on the Wheelchair Skills Training Program 4.1 .


The powered Wheelchair Skills Test version 4.1 was administered at baseline ( T1 ) and after training ( T2 ) .


A rank order analysis of covariance on the T2 Wheelchair Skills Test score , having adjusted for the T1 score , showed a significant effect caused by group ( P = 0.0001 ) .


A secondary analysis showed no significant effect caused by spatial neglect ( P = 0.923 ) .


People with stroke who receive formal powered wheelchair skills training improve their powered wheelchair skills to a significantly greater extent ( 30 % ) than participants who do not ( 0 % ) .


The extent of change was not affected by the presence of spatial neglect .


These findings have significance for the wheelchair provision process and the rehabilitation of people with stroke .


The aims of this paper are ( i ) to compare the excitability of visual cortex in migraine patients with healthy volunteers ; and ( ii ) if an abnormal excitability has been found , to modulate cortical excitability in migraine patients with transcranial direct current stimulation ( tDCS ) and observe their clinical and neurophysiological effects .


The study was divided into two steps .


A cross-sectional study ( step 1 ) was conducted to compare the cortical excitability of 23 migraineurs ( 11 with and 12 without aura ) on 11 healthy individuals .


On step 2 , a randomized , double blinded , controlled pilot trial was carried on with 19 migraineurs , randomly divided into : experimental and control group .


During 12 sessions , experimental and group received active tDCS to visual cortex and control group received sham tDCS .


The headache diary was applied for a total of 90days ( before , during and after tDCS sessions ) .


Phosphene threshold ( PT ) induced by transcranial magnetic stimulation was recorded to measure the excitability of the visual cortex before and after each session .


Step 1 showed higher level of cortical excitability between migraineurs when compared to healthy volunteers ; therefore , cathodal tDCS was applied over visual cortex in step 2 .


After tDCS application , a significant decrease was observed in a number of migraine attacks , painkiller intake and duration of each attack just in experimental group .


The analysis of PT indicated no difference in cortical excitability after tDCS .


Findings of the study suggested that inhibitory tDCS on visual cortex might be an alternative and non-pharmacological treatment for migraine prophylaxis .


However the clinical improvements of patients after tDCS treatment are not correlated with changes in cortical excitability .


To evaluate breast self examination ( BSE ) practice and the effect of a training program conducted by healthcare professionals on BSE .


Women were randomized into control and test groups with both groups completing a questionnaire and three independent interviews where their BSE practices were evaluated .


In all , 39.5 % of the participants were previously provided information on BSE by healthcare professionals while 25.8 % had no knowledge of BSE prior to enrollment .


Compared to those informed about BSE through other means such as television , radio , and the internet , the scores of the first , second , and third visits were higher ( p < 0.05 ) in individuals who received BSE education from healthcare professionals and hospitals .


BSE training provided by healthcare professionals may increase early breast cancer diagnosis and treatment rates by improving BSE awareness and practice .


This study aimed to assess the efficacy of early intensive diabetes therapy with either insulin plus metformin ( INS ) or triple oral therapy ( TOT ) with metformin , glyburide , and pioglitazone on glycemic control and A-cell function .


Fifty-eight treatment-naive newly diagnosed patients with type 2 diabetes underwent a 3-month lead-in treatment period with insulin and metformin , then were randomized to INS or TOT for 6 years .


- Cell function was measured using mixed-meal challenge test .


- Cell function remained stable throughout the 6-year study in both groups , as measured by the C-peptide area under the curve ( AUC ; P = 0.13 ) , the AUC C-peptide/AUC glucose ( P = 0.9 ) , and by the disposition index ( P = 0.8 ) .


Excellent glycemic control was maintained in both groups ( end-of-study hemoglobinA1c , 7.3 % [ SD , 1.7 % ] INS vs 6.4 % [ 1.4 % ] TOT ; P = 0.4 ) .


There were 8 treatment failures ( confirmed hemoglobinA1c , 98 % ) in INS and 6 in TOT ( P = 0.93 ) .


The predictors of treatment failure included higher fasting glucose ( P = 0.008 ) , fasting C-peptide ( P = 0.008 ) , systolic blood pressure ( P = 0.004 ) , and lower insulin sensitivity ( P = 0.04 ) at randomization .


Early intensive treatment at the time of type 2 diabetes diagnosis-initial short-term insulin treatment followed by either insulin-based or intensive oral hypoglycemic-based therapy-stabilizes - cell function for at least 6 years .


Treatment failure was independent of intervention and was associated with worse disease pathology at baseline .


To investigate the change in eating behavior and the factors related with the change among successful dieters ( maintained a weight loss of 5 % of original weight ) .


Obese adult subjects ( 21 male , 55 female ) were randomized into three-year lifestyle intervention ( n = 59 ) and control groups ( n = 17 ) .


Eating behavior ( cognitive restraint of eating , uncontrolled eating and emotional eating ) was evaluated by the TFEQ-18 and motivation to lose weight and tolerance to problems by a separate questionnaire .


Weight , height and body mass index were measured .


Weight decreased more in the intervention group than in the control group ( 5.0 % vs 0.6 % , p = 0.027 ) .


Cognitive restraint increased twice as much in the intervention group compared to the control group ( 16.0 vs. 7.0 , p = 0.044 ) .


The increment in cognitive restraint was positively associated with weight loss and high baseline motivation and tolerance to problems .


Cognitive restraint increased in both successful ( n = 27 ) and unsuccessful dieters ( n = 32 ) , but only the successful dieters were able to decrease uncontrolled eating in the long term .


Our results showed that intensive lifestyle counseling improved cognitive restraint which was associated with enhanced weight loss among obese adults .


Successful dieters also showed a long-term improvement of uncontrolled eating .


Eating behavior should be evaluated and followed before and during lifestyle interventions in order to support the change , e.g. by finding methods to control eating at risk situations and strengthening motivation and tolerance to problems .


The aim of this study was to evaluate the effects of premedication with oral atenolol or enalapril , in combination with remifentanil under sevoflurane anesthesia , on intraoperative blood loss by achieving adequate deliberate hypotension ( DH ) during orthognathic surgery .


Furthermore , we investigated the impact thereof on the amount of nitroglycerin ( NTG ) administered as an adjuvant agent .


Seventy-three patients undergoing orthognathic surgery were randomly allocated into one of three groups : an angiotensin converting enzyme inhibitor group ( Group A , n = 24 ) with enalapril 10 mg , a blocker group ( Group B , n = 24 ) with atenolol 25 mg , or a control group ( Group C , n = 25 ) with placebo .


All patients were premedicated orally 1 h before the induction of anesthesia .


NTG was the only adjuvant agent used to achieve DH when mean arterial blood pressure ( MAP ) was not controlled , despite the administration of the maximum remifentanil dose ( 0.3 g kg min ) with sevoflurane .


Seventy-two patients completed the study .


Blood loss was significantly reduced in Group A , compared to Group C ( adjusted p = 0.045 ) .


Over the target range of MAP percentage during DH was significantly higher in Group C than in Groups A and B ( adjusted p-values = 0.007 and 0.006 , respectively ) .


The total amount of NTG administered was significantly less in Group A than Group C ( adjusted p = 0.015 ) .


Premedication with enalapril ( 10 mg ) combined with remifentanil under sevoflurane anesthesia attenuated blood loss and achieved satisfactory DH during orthognathic surgery .


Furthermore , the amount of NTG was reduced during the surgery .


To compare a peer leader ( PL ) versus a community health worker ( CHW ) telephone outreach intervention in sustaining improvements in HbA1c over 12 months after a 6-month diabetes self-management education ( DSME ) program .


One hundred and sixteen Latino adults with type 2 diabetes were recruited from a federally qualified health center and randomized to ( 1 ) a 6-month DSME program followed by 12 months of weekly group sessions delivered by PLs with telephone outreach to those unable to attend or ( 2 ) a 6-month DSME program followed by 12 months of monthly telephone outreach delivered by CHWs .


The primary outcome was HbA1c .


Secondary outcomes were cardiovascular disease risk factors , diabetes distress , and diabetes social support .


Assessments were conducted at baseline , 6 , 12 , and 18 months .


After DSME , the PL group achieved a reduction in mean HbA1c ( 8.2-7 .5 % or 66-58 mmol/mol , P < 0.0001 ) that was maintained at 18 months ( -0.6 % or -6.6 mmol/mol from baseline [ P = 0.009 ] ) .


The CHW group also showed a reduction in HbA1c ( 7.8 vs. 7.3 % or 62 vs. 56 mmol/mol , P = 0.0004 ) post-6 month DSME ; however , it was attenuated at 18 months ( -0.3 % or -3.3 mmol/mol from baseline , within-group P = 0.234 ) .


Only the PL group maintained improvements achieved in blood pressure at 18 months .


At the 18-month follow-up , both groups maintained improvements in waist circumference , diabetes support , and diabetes distress , with no significant differences between groups .


Both low-cost maintenance programs led by either a PL or a CHW maintained improvements in key patient-reported diabetes outcomes , but the PL intervention may have additional benefit in sustaining clinical improvements beyond 12 months .


The provision of several doses of monovalent type 1 oral poliovirus vaccine ( mOPV1 ) and bivalent OPV1 and 3 ( bOPV ) vaccines through campaigns is essential to stop the circulation of remaining wild polioviruses .


Our study aimed to assess the shortening of intervals between campaigns with bOPV and mOPV1 and to assess the immunogenicity of bOPV in routine immunisation schedules .


We did an open-label , non-inferiority , five-arm , randomised controlled trial in Bangladesh .


We recruited healthy infants aged 6 weeks at 42 immunisation clinics and randomly assigned them ( with blocks of 15 , three per group ) to receive a short three-dose schedule of bOPV ( bOPV short ) or mOPV1 ( mOPV1 short ) with the first dose given at age 6 weeks , the second at age 8 weeks , and the third at age 10 weeks ; or to a standard three-dose schedule of bOPV ( bOPV standard ) or mOPV1 ( mOPV1 standard ) or trivalent OPV ( tOPV standard ) with the first dose given at age 6 weeks , the second at 10 weeks , and the third at age 14 weeks .


The primary outcome was the proportion of infants with antibody seroconversion for type 1 , type 2 , and type 3 polioviruses .


The primary , modified intention-to-treat analysis included all patients who had testable serum samples before and after receiving at least one OPV dose .


We used a 10 % margin to establish non-inferiority for bOPV groups versus mOPV1 groups in seroconversion for type 1 poliovirus , and for bOPV1 short versus bOPV1 standard for types 1 and 3 .


This trial is registered at ClinicalTrials.gov , number NCT01633216 , and is closed to new participants .


Between May 13 , 2012 , and Jan 21 , 2013 , we randomly assigned 1000 infants to our study groups .


927 completed all study visits and were included in the primary analysis .


Seroconversion for type-1 poliovirus was recorded in 183 ( 98 % , 95 % CI 95-100 ) of 186 infants given bOPV short , 179 ( 97 % , 94-99 ) of 184 given bOPV standard , 180 ( 96 % , 92-98 ) of 188 given mOPV short , 178 ( 99 % , 97-100 ) of 179 given mOPV1 standard , and 175 ( 92 % , 87-96 ) of 190 given tOPV standard .


Seroconversion for type 2 was noted in 16 infants ( 9 % , 5-14 ) on bOPV short , 29 ( 16 % , 11-22 ) on bOPV standard , 19 ( 10 % , 7-15 ) on mOPV short , 33 ( 18 % , 13-25 ) on mOPV1 standard , and 182 ( 96 % , 92-98 ) on tOPV standard .


Seroconversion for type 3 was noted in 175 infants ( 94 % , 90-97 ) on bOPV short , 176 ( 96 % , 92-98 ) on bOPV standard , 18 ( 10 % , 6-15 ) on mOPV short , 25 ( 14 % , 10-20 ) on mOPV1 standard , and 167 ( 88 % , 83-92 ) on tOPV standard .


The short schedules for mOPV1 and bOPV elicited a non-inferior antibody response compared with the bOPV standard schedule .


104 adverse events were reported in 100 infants during follow up .


36 of these events needed admission to hospital ( 32 were pneumonia , two were vomiting or feeding disorders , one was septicaemia , and one was diarrhoea with severe malnutrition ) .


One of the infants admitted to hospital for pneumonia died 5 days after admission .


No adverse event was attributed to the vaccines .


Our trial showed that three doses of mOPV1 or bOPV with a short schedule of 2 week intervals between doses induces an immune response similar to that obtained with the standard schedule of giving doses at 4 week intervals .


These findings support the use of these vaccines in campaigns done at short intervals to rapidly increase population immunity against polioviruses to control outbreaks or prevent transmission in high-risk areas .


Centers for Disease Control and Prevention and UNICEF .


To study the immediate and short-term efficacy of adding transcutaneous electrical nerve stimulation ( TENS ) to standardized physical therapy on subacute spasticity within 6 months of spinal cord injury .


Randomized controlled trial for 3 weeks .


A university hospital .


Subjects ( N = 16 ) with clinically determined spasticity were randomly assigned to either the experimental group ( n = 8 ) or the control group ( n = 8 ) .


Sixty-minute sessions of TENS over the bilateral common peroneal nerves before 30 minutes of physical therapy for the experimental group and 30 minutes of physical therapy alone for the control group .


All patients in both groups had access to standardized rehabilitation care .


The composite spasticity score , which included 3 subscores ( ankle jerk , muscle tone , and ankle clonus scores ) , was used as the primary end point to assess plantar flexor spasticity .


These subscores were designated as secondary end points .


Serial evaluations were made at baseline before study entry and immediately after the first and last sessions in both groups .


On analysis for immediate effects , there was a significant reduction only in the composite spasticity score ( mean difference , 1.75 ; 99 % confidence interval [ CI ] , 0.47-3 .03 ; P = .002 ) in the experimental group , but no significant reduction was observed in all outcome variables in the control group .


A significant difference in the composite spasticity score ( 1.63 ; 99 % CI , 0.14-3 .11 ; P = .006 ) was observed between the 2 groups .


After 15 sessions of treatment , a significant reduction was determined in the composite spasticity score ( 2.75 ; 99 % CI , 1.31-4 .19 ; P < .001 ) , the muscle tone score ( 1.75 ; 99 % CI , 0.16-3 .34 ; P = .006 ) , and the ankle clonus score ( 0.75 ; 99 % CI , 0.18-1 .32 ; P = .003 ) in the experimental group , whereas none of the outcome variables revealed a significant reduction in the control group .


The between-group difference was significant only for the composite spasticity score ( 2.13 ; 99 % CI , 0.59-3 .66 ; P = .001 ) and the muscle tone score ( 1.50 ; 99 % CI , 0.15-2 .85 ; P = .005 ) after 15 intervention sessions .


Addition of TENS to standardized physical therapy had synergistically antispastic action , providing more effective reduction of clinical spasticity .


To determine whether the immunogenicity of a single dose infant priming schedule of serogroup C meningococcal ( MenC ) conjugate vaccine is non-inferior to a two dose priming schedule when followed by a booster dose at age 12 months .


Phase IV open label randomised controlled trial carried out from July 2010 until August 2013 SETTING : Four centres in the United Kingdom and one centre in Malta .


Healthy infants aged 6-12 weeks followed up until age 24 months .


In the priming phase of the trial 509 infants were randomised in a 10:10:7:4 ratio into four groups to receive either a single MenC-cross reacting material 197 ( CRM ) dose at 3 months ; two doses of MenC-CRM at 3 and 4 months ; a single MenC-polysaccharide-tetanus toxoid ( TT ) dose at 3 months ; or no MenC doses , respectively .


Haemophilus influenzae type b ( Hib ) - MenC-TT vaccine was administered to all infants at 12 months of age .


All infants also received the nationally routinely recommended vaccines .


Blood samples were taken at age 5 , 12 , 13 , and 24 months .


MenC serum bactericidal antibody assay with rabbit complement ( rSBA ) one month after the Hib-MenC-TT vaccine .


Non-inferiority was met if the lower 95 % confidence limit of the difference in the mean log10 MenC rSBA between the single dose MenC-CRM and the two dose MenC-CRM groups was > -0.35 .


The primary objective was met : after a Hib-MenC-TT booster dose at 12 months of age the MenC rSBA geometric mean titres induced in infants primed with a single MenC-CRM dose were not inferior to those induced in participants primed with two MenC-CRM doses in infancy ( 660 ( 95 % confidence interval 498 to 876 ) v 295 ( 220 to 398 ) ) with a corresponding difference in the mean log10 MenC rSBA of 0.35 ( 0.17 to 0.53 ) that showed superiority of the single over the two dose schedule ) .


Exploration of differences between the priming schedules showed that one month after Hib-MenC-TT vaccination , MenC rSBA 1:8 was observed in > 96 % of participants previously primed with any of the MenC vaccine schedules in infancy and in 83 % of those who were not vaccinated against MenC in infancy .


The MenC rSBA geometric mean titres induced by the Hib-MenC-TT boost were significantly higher in children who were primed with one rather than two MenC-CRM doses in infancy .


Only priming with MenC-TT , however , induced robust MenC bactericidal antibody after the Hib-MenC-TT booster that persisted until 24 months of age .


MenC vaccination programmes with two MenC infant priming doses could be reduced to a single priming dose without reducing post-boost antibody titres .


When followed by a Hib-MenC-TT booster dose , infant priming with a single MenC-TT vaccine dose induces a more robust antibody response than one or two infant doses of MenC-CRM .


Bactericidal antibody induced by a single Hib-MenC-TT conjugate vaccine dose at 12 months of age ( that is , a toddler only schedule ) , without infant priming , is not well sustained at 24 months .


Because of rapid waning of MenC antibody , programmes using toddler only schedules will still need to rely on herd protection to protect infants and young children.Trial registration Eudract No : 2009-016579-31 ; NCT01129518 ; study ID : 2008_06 ( http://clinicaltrials.gov ) .


To evaluate skin irritation and patch adhesiveness of a new weekly low-dose levonorgestrel ( LNG ) and ethinyl estradiol ( EE ) contraceptive patch ( LNG/EE patch ) .


This analysis was part of an open-label , parallel-group , multicenter , phase 3 study that randomized healthy women to the LNG/EE patch ( one patch weekly for three consecutive weeks , followed by a patch-free week for 13 cycles ) or to an oral contraceptive for six cycles followed by seven LNG/EE patch cycles .


Participants selected patch application sites of abdomen , buttock or upper torso .


Investigators rated patch adhesiveness and skin irritation using standardized scales .


Participants rated skin irritation and itching daily using standardized scales and recorded patch fall-off on daily diary cards .


A total of 32,508 patches were applied ( n = 1273 ) .


At the five clinic visits in which investigators rated the patches , they rated adhesiveness = 0 ( no lift ) for 84 % of participants and skin irritation = absent/mild for 97 % of patches .


Participants reported that 2-3 .7 % of patches fell off and rated skin irritation as absent or mild for 92 - 95 % of patches , according to site .


Investigator - and participant-rated assessments of LNG/EE patch adhesiveness and irritation demonstrated a low incidence of patch detachment , skin irritation and pruritus .


This secondary analysis of a phase 3 clinical trial of a new weekly low-dose LNG and EE contraceptive patch , which used assessment by both investigators and participants , observed a low incidence of skin irritation , pruritus and patch detachment .


We examine the role of body mass index in the assessment of prostate cancer risk .


A total of 3,258 participants who underwent biopsy ( including 1,902 men with a diagnosis of prostate cancer ) were identified from the Selenium and Vitamin E Cancer Prevention Trial .


The associations of body mass index with prostate cancer and high grade prostate cancer were examined using logistic regression , adjusting for age , race , body mass index adjusted prostate specific antigen , digital rectal examination , family history of prostate cancer , biopsy history , prostate specific antigen velocity , and time between study entry and the last biopsy .


The prediction models were compared with our previously developed body mass index adjusted Prostate Cancer Prevention Trial prostate cancer risk calculator .


Of the study subjects 49.1 % were overweight and 29.3 % were obese .


After adjustment , among men without a known family history of prostate cancer , increased body mass index was not associated with a higher risk of prostate cancer ( per one-unit increase in logBMI OR 0.83 , p = 0.54 ) but was significantly associated with a higher risk of high grade prostate cancer ( ieGleason score 7 or greater prostate cancer ) ( OR 2.31 , p = 0.03 ) .


For men with a known family history of prostate cancer the risks of prostate cancer and high grade prostate cancer increased rapidly as body mass index increased ( prostate cancer OR 3.73 , p = 0.02 ; high grade prostate cancer OR 7.95 , p = 0.002 ) .


The previously developed risk calculator generally underestimated the risks of prostate cancer and high grade prostate cancer .


Body mass index provided independently predictive information regarding the risks of prostate cancer and high grade prostate cancer after adjusting for other risk factors .


Body mass index , especially in men with a known family history of prostate cancer , should be considered for inclusion in any clinical assessment of prostate cancer risk and recommendations regarding prostate biopsy .


Fast track recovery is a care process goal after cardiac surgery .


Intraoperative anesthetic depth may impact recovery , but the impact of brain monitoring on time to extubation and intensive care unit ( ICU ) length of stay after cardiac surgery has not been extensively studied .


Our goal was to determine if BIS-guided anesthesia improves time to extubation compared to MAC-guided anesthesia in a cardiac surgery population .


In this secondary outcome analysis of a randomized controlled study , we analyzed 294 patients undergoing elective coronary bypass grafting , valve replacements , and bypass plus valve replacements at a single tertiary referral center between February 1 , 2009 and April 30 , 2010 .


We analyzed cardiac surgery patients that had been randomized to BIS-guided anesthesia alerts ( n = 131 ) or MAC-guided anesthesia alerts ( n = 163 ) .


The primary outcome measure was time to extubation in the BIS-guided and anesthetic concentration-guided groups .


Secondary outcomes were length of stay in the ICU and total postoperative hospital length of stay .


Valid extubation time data were available for 247 of 294 patients .


The median [ IQR ] time to extubation was 307 [ 215 to 771 ] minutes in the BIS group and 323 [ 196 to 730 ] minutes in the anesthetic concentration group ( p = 0.61 ) .


The median [ IQR ] ICU length of stay was 54 [ 29 to 97 ] hours versus 70 [ 44 to 99 ] hours ( p = 0.11 ) .


In terms of postoperative hospital length of stay , there was no difference between the groups with median [ IQR ] times of 6 [ 5-8 ] days ( p = 0.69 ) in each group .


The use of intraoperative BIS monitoring during cardiac surgery did not change time to extubation , ICU length of stay or hospital length of stay .


Data regarding BIS monitoring and recovery in an exclusively cardiac surgery population are consistent with recent effectiveness studies in the general surgical population .


ClinicalTrials.gov number NCT00689091 .


Behavioral and psychological symptoms of dementia ( BPSD ) are often considered to be the greatest challenge in dementia care , leading to increased healthcare costs , caregiver burden , and placement into care facilities .


With potential for pharmacological intervention to exacerbate behaviors or even lead to mortality , the development and rigorous testing of non-pharmacological interventions is vital .


A pilot of the Tailored Activities Program ( TAP ) for reducing problem behaviors in people with dementia was conducted in the United States with promising results .


This randomized trial will investigate the effectiveness of TAP for reducing the burden of BPSD on persons with dementia and family caregivers within an Australian population .


This trial will also examine the cost-effectiveness and willingness to pay for TAP compared with a control group .


This randomized trial aims to recruit 180 participant dyads of a person with dementia and their caregivers .


Participants will have a diagnosis of dementia , exhibit behaviors as scored by the Neuropsychiatric Inventory , and the caregiver must have at least 7 h per week contact .


Participants will be randomly allocated to intervention ( TAP ) or control ( phone-based education sessions ) groups , both provided by a trained occupational therapist .


Primary outcome measure will be the revised Neuropsychiatric Inventory - Clinician rating scale ( NPI-C ) to measure BPSD exhibited by the person with dementia .


This trial investigates the effectiveness and cost-effectiveness of TAP within an Australian population .


Results will address a significant gap in the current Australian community-support base for people living with dementia and their caregivers .


Armodafinil is a medication used to treat excessive sleepiness in individuals with shift work disorder ( SWD ) .


In the present study , we investigate whether armodafinil can normalize nocturnal sleepiness in a group of typical SWD patients .


Participants were 12 night workers ( aged 33.8 8.57 years , 7 female subjects ) with excessive sleepiness ( 10 on the Epworth Sleepiness Scale ; mean , 14.8 3.16 ) , meeting the International Classification of Sleep Disorders , Second Edition criteria for SWD , with no other sleep or medical disorders verified by polysomnogram .


The multiple sleep latency test ( MSLT ) was not used as an entry criteria .


Armodafinil was administered at 10:30 pm in a randomized , double-blind , placebo-controlled , crossover design with experimental nights separated by 1 week .


Primary end point was the MSLT , with naps at 1:30 , 3:30 , 5:30 , and 7:30 am .


Other study measures included a sleepiness-alertness visual analog scale administered before each nap , and 2 computer-based performance tests evaluating attention and memory .


Subjects with SWD had a mean MSLT of 5.3 3.25 minutes , indicating a mean level of pathological sleepiness .


Armodafinil significantly improved MSLT score to 11.1 4.79 minutes ( P = 0.006 ) .


Subjective levels of alertness on the visual analog scale also improved ( P = 0.008 ) .


For performance , reaction time to central ( P = 0.006 ) and peripheral ( P = 0.003 ) stimuli and free recall memory ( P = 0.05 ) were also improved .


Armodafinil 150 mg administered at the beginning of a night shift normalizes nocturnal sleepiness in individuals with SWD unselected for objective sleepiness .


Subjective measures of sleepiness and cognitive performance are also improved .


This suggests that armodafinil can improve levels of nocturnal alertness to within normal daytime levels in the majority of patients with SWD .


HIV-1 transmitted drug resistance ( TDR ) in treatment-nave individuals is a well-described phenomenon .


Baseline genotypic resistance testing is considered standard of care in most developed areas of the world .


The aim of this analysis was to characterize HIV-1 TDR and the use of resistance testing in START trial participants .


In the Strategic Timing of AntiRetroviral Treatment ( START ) trial , baseline genotypic resistance testing results were collected at study entry and analysed centrally to determine the prevalence of TDR in the study population .


Resistance was based on a modified 2009 World Health Organization definition to reflect newer resistance mutations .


Baseline resistance testing was available in 1946 study participants .


Higher rates of testing occurred in Europe ( 86.7 % ) , the USA ( 81.3 % ) and Australia ( 89.9 % ) as compared with Asia ( 22.2 % ) , South America ( 1.8 % ) and Africa ( 0.1 % ) .


The overall prevalence of TDR was 10.1 % , more commonly to nonnucleoside reverse transcriptase inhibitors ( 4.5 % ) and nucleoside reverse transcriptase inhibitors ( 4 % ) compared with protease inhibitors ( 2.8 % ) .


The most frequent TDR mutations observed were M41L , D67N/G/E , T215F/Y/I / S/C/D / E/V/N , 219Q/E/N / R , K103N/S , and G190A/S/E in reverse transcriptase , and M46I/L and L90M in protease .


By country , the prevalence of TDR was highest in Australia ( 17.5 % ) , France ( 16.7 % ) , the USA ( 12.6 % ) and Spain ( 12.6 % ) .


No participant characteristics were identified as predictors of the presence of TDR .


START participants enrolled in resource-rich areas of the world were more likely to have baseline resistance testing .


In Europe , the USA and Australia , TDR prevalence rates varied by country .


To assess the efficacy of epidural motor cortex stimulation ( MCS ) on dystonia , spasticity , pain , and quality of life in patients with dystonia secondary to a focal basal ganglia ( BG ) lesion .


In this double-blind , crossover , multicenter study , 5 patients with dystonia secondary to a focal BG lesion were included .


Two quadripolar leads were implanted epidurally over the primary motor ( M1 ) and premotor cortices , contralateral to the most dystonic side .


The leads were placed parallel to the central sulcus .


Only the posterior lead over M1 was activated in this study .


The most lateral or medial contact of the lead ( depending on whether the dystonia predominated in the upper or lower limb ) was selected as the anode , and the other 3 as cathodes .


One month postoperatively , patients were randomly assigned to on - or off-stimulation for 3 months each , with a 1-month washout between the 2 conditions .


Voltage , frequency , and pulse width were fixed at 3.8 V , 40 Hz , and 60 s , respectively .


Evaluations of dystonia ( Burke-Fahn-Marsden Scale ) , spasticity ( Ashworth score ) , pain intensity ( visual analog scale ) , and quality of life ( 36-Item Short Form Health Survey ) were performed before surgery and after each period of stimulation .


Burke-Fahn-Marsden Scale , Ashworth score , pain intensity , and quality of life were not statistically significantly modified by MCS .


Bipolar epidural MCS failed to improve any clinical feature in dystonia secondary to a focal BG lesion .


This study provides Class I evidence that bipolar epidural MCS with the anode placed over the motor representation of the most affected limb failed to improve any clinical feature in dystonia secondary to a focal BG lesion .


Intermittent normobaric hypoxia training , an alternative to altitude training for athletes , may be beneficial to treat overweight and obesity .


The purpose of this study is to investigate whether normobaric hypoxia training combined with low-caloric diet has the additive effect on weight loss compared with normoxia training in obese young adults .


Twenty-two subjects ( age 17-25 years , body mass index > 27.5 kg/m ( 2 ) ) were recruited for a 4-week residential camp of weight loss with low caloric intake , and trained at 60-70 % maximal heart rate of aerobics and 40-50 % of maximal strength of training .


They were randomly assigned to either a normobaric hypoxia ( HT , FiO2 = 16.4-14 .5 % ) or normoxia training group ( NT , FiO2 = 21 % ) , and subjects in HT and NT groups experienced weekly 16-h normoxia and 6-h hypoxia or 22-h normoxia training , respectively .


Body composition , resting blood pressure ( BP ) and brachial-ankle pulse wave velocity ( baPWV ) were determined before and after the intervention .


Weight loss was found in HT ( -6.9 kg or -7.0 % , p < 0.01 ) and NT groups ( -4.3 kg or -4.2 % , p < 0.01 ) significantly , and the former lost more weight than the latter ( p < 0.01 ) .


Hypoxia training improved systolic BP ( -7.6 % ) and mean BP ( -7.1 % ) significantly ( p < 0.05 ) despite having no effect on baPWV .


Four weeks of normobaric hypoxia residential training with low caloric diet has an additive improvement on weight loss .


It seems that normobaric hypoxia training might be a promising method to treat obesity .


Determine the cost-effectiveness of extracellular matrix ( ECM ) relative to human fibroblast-derived dermal substitute ( HFDS ) on diabetic foot ulcer ( DFU ) wound closure .


Outcomes data were obtained from a 12-week , randomised , clinical trial of adults aged 18 years or older diagnosed with type 1 or type 2 diabetes with a DFU .


Patients were treated with either ECM or HFDS treatment .


A two-state Markov model ( healed and unhealed ) with a 1-week cycle length was developed using wound-closure rates from the trial to estimate the number of closed-wound weeks and the expected DFU cost per patient .


Results were recorded over 12 weeks to estimate the number of closed-wound weeks per treatment and the average cost to achieve epithelialisation ( primary outcome ) .