Two-weeks before starting university all incoming undergraduates at the University of Sheffield were invited to take part in a study of new students ' health behaviour .


A randomised controlled design , with a baseline questionnaire , and two follow-ups ( 1 and 6 months after starting university ) , was used to evaluate the intervention .


Primary outcomes were measures of the four health behaviours targeted by the intervention at 6-month follow-up , i.e. , portions of fruit and vegetables , metabolic equivalent of tasks ( physical activity ) , units of alcohol , and smoking status .


The study recruited 1,445 students ( intervention n = 736 , control n = 709 , 58 % female , Mean age = 18.9 years ) , of whom 1,107 completed at least one follow-up ( 23 % attrition ) .


The intervention had a statistically significant effect on one primary outcome , smoking status at 6-month follow-up , with fewer smokers in the intervention arm ( 8.7 % ) than in the control arm ( 13.0 % ; Odds ratio = 1.92 , p = .010 ) .


There were no significant intervention effects on the other primary outcomes ( physical activity , alcohol or fruit and vegetable consumption ) at 6-month follow-up .


The results of the RCT indicate that the online health behaviour intervention reduced smoking rates , but it had little effect on fruit and vegetable intake , physical activity or alcohol consumption , during the first six months at university .


However , engagement with the intervention was low .


Further research is needed before strong conclusions can be made regarding the likely effectiveness of the intervention to promote health lifestyle habits in new university students .


Current Controlled Trials , ISRCTN67684181 .


Frequent self-weighing is linked with weight management success , but concern has been raised about its possible association with unhealthy practices .


This study examined the association of self-weighing with other weight control behaviors in a sample for whom frequent weighing might be questioned -- namely , normal-weight or overweight ( BMI of 21-29 .9 ) young adults ( age 18-35 ) .


Participants ( N = 583 ; mean [ SD ] age = 27.7 [ 4.4 ] ; BMI = 25.4 [ 2.6 ] ) entering the Study of Novel Approaches to Weight Gain Prevention ( SNAP ) completed objective measures of weight and physical activity and self-reported weight history , use of healthy and unhealthy weight control strategies , depressive symptoms , and dietary intake .


Daily self-weighing was reported by 11 % of participants , and 23 % weighed several times per week .


Frequent weighing was not associated with current BMI , gender , or age but was associated with being further below one 's highest weight , history of dieting , and perceived difficulty maintaining weight .


Frequent weighing was associated with healthy weight management strategies , but not with unhealthy practices or depressive symptoms .


In this sample , frequent self-weighing appears to be part of a constellation of healthy weight control behaviors used to counteract a perceived tendency toward weight gain .


SNAP follow-up will determine whether frequent self-weighing helps prevent weight gain .


This prospective phase II study was designed to assess disease control and to describe acute and late adverse effects of treatment with proton radiotherapy in children with rhabdomyosarcoma ( RMS ) .


Fifty-seven patients with localized RMS ( age 21 years or younger ) or metastatic embryonal RMS ( age 2 to 10 years ) were enrolled between February 2005 and August 2012 .


All patients were treated with chemotherapy based on either vincristine , actinomycin , and cyclophosphamide or vincristine , actinomycin , and ifosfamide-based chemotherapy and proton radiation .


Surgical resection was based on tumor site and accessibility .


Common Terminology Criteria for Adverse Events , Version 3.0 , was used to assess and grade adverse effects of treatment .


Concurrent enrollment onto Children 's Oncology Group or European Pediatric Sarcoma Study Group protocols was allowed .


All pathology and imaging were reviewed at the treating institution .


Median follow-up was 47 months ( range , 14 to 102 months ) for survivors .


Five-year event-free survival ( EFS ) , overall survival ( OS ) , and local control ( LC ) were 69 % , 78 % , and 81 % , respectively , for the entire cohort .


The 5-year LC by risk group was 93 % for low-risk and 77 % for intermediate-risk disease .


There were 13 patients with grade 3 acute toxicity and three patients with grade 3 late toxicity .


There were no acute or late toxicities higher than grade 3 .


Five-year LC , EFS , and OS rates were similar to those observed in comparable trials that used photon radiation .


Acute and late toxicity rates were favorable .


Proton radiation appears to represent a safe and effective radiation modality for pediatric RMS .


To compare the perioperative data , pathological results and functional outcomes of transvesical single - site laparoscopic radical prostatectomy ( TVSSLRP ) with those of nerve-sparing extraperitoneal laparoscopic radical prostatectomy ( nsELRP ) in the treatment of low-risk prostate cancer ( PCa ) .


Fifty patients with low-risk organ-confined PCa were randomly assigned to two groups of equal number to receive TVSSLRP and nsELRP , respectively .


Comparisons were made between the two groups of patients in such demographic and baseline data as age , comorbidity , body mass index ( BMI ) , serum prostate-specific antigen ( PSA ) , prostate volume , bioptic Gleason score , clinical stage , IIEF-5 score , nocturnal penile tumescence ( NPT ) , penile brachial index ( PBI ) , and penile arterial blood flow velocity as well as in such surgery-related parameters as operation duration , blood loss , blood transfusion , intraoperative complications , positive surgical margin , catheterization time , hospital stay , and postoperative Gleason score , pathologic stage , urinal pad use , PSA level , IIEF-5 score , NPT , PBI and PABFV .


All the operations were successfully performed .


There were no statistically significant differences between the two groups either in the demographic and baseline data or in intraoperative blood loss , blood transfusion rate , complications , and positive surgical margin .


No intraoperative complications and positive surgical margins were found in either group .


Compared with nsELRP , TVSSLRP achieved a significantly shorter operation duration ( [ 151.46 40.68 ] min vs [ 105.92 26.21 ] min , P < 0.05 ) , catheterization time ( [ 13.01 1.64 ] d vs [ 11.24 1.17 ] d , P < 0.05 ) , and hospital stay ( [ 15.76 4.65 ] d vs [ 12.92 4.29 ] d , P < 0.05 ) .


On the first day and at 1 , 3 and 6 months after catheter removal , the urinary continence rates in the TVSSLRP and nsELRP groups were 84 % vs 52 % ( P < 0.05 ) , 100 % vs 84 % , 100 % vs 96 % , and 100 % vs 96 % , respectively ; and at 3 , 6 and 12 months after surgery , the erectile potency rates were 48 % vs 28 % ( P < 0.05 ) , 64 % vs 52 % , and 76 % vs 68 % , respectively , with an IIEF-5 score 18 , all evidently higher in the TVSSLRP than in the nsELRP group .


The penile brachial index and arterial blood flow velocity of the two groups of patients exhibited no significant differences before and after surgery , nor did postoperative complications ( grade II ) between the TVSSLRP and nsELRP groups ( 32 % vs 40 % , P > 0.05 ) .


The Gleason score and pathologic stage were increased after surgery , but with remarkable differences between the two groups ( P > 0.05 ) .


No biochemical recurrence was found in either group during a 12-month follow-up .


With the advantages of safety and rapid postoperative recovery , both TVSSLRP and nsELRP are feasible for the treatment of low-risk organ-confined PCa , but the former may achieve an earlier recovery of urinary continence and erectile function than the latter .


The objective of this study was to examine the associations between baseline electroencephalogram ( EEG ) - assessed brain oscillations and subsequent response to four neuromodulatory treatments .


Based on available research , we hypothesized that baseline theta oscillations would prospectively predict response to hypnotic analgesia .


Analyses involving other oscillations and the other treatments ( meditation , neurofeedback , and both active and sham transcranial direct current stimulation ) were viewed as exploratory , given the lack of previous research examining brain oscillations as predictors of response to these other treatments .


Randomized controlled study of single sessions of four neuromodulatory pain treatments and a control procedure .


Thirty individuals with spinal cord injury and chronic pain had their EEG recorded before each session of four active treatments ( hypnosis , meditation , EEG biofeedback , transcranial direct current stimulation ) and a control procedure ( sham transcranial direct stimulation ) .


As hypothesized , more presession theta power was associated with greater response to hypnotic analgesia .


In exploratory analyses , we found that less baseline alpha power predicted pain reduction with meditation .


The findings support the idea that different patients respond to different pain treatments and that between-person treatment response differences are related to brain states as measured by EEG .


The results have implications for the possibility of enhancing pain treatment response by either 1 ) better patient/treatment matching or 2 ) influencing brain activity before treatment is initiated in order to prepare patients to respond .


Research is needed to replicate and confirm the findings in additional samples of individuals with chronic pain .


The purpose of this study was to assess the efficacy of a 12 week , self-managed , community-based stretching program on musculoskeletal fitness , musculoskeletal symptoms , and acculturative stress , in Korean-Chinese female migrant workers in Korea .


This was a randomized controlled trial with random assignment of eligible full-time Korean-Chinese female migrant workers to a stretching exercise intervention ( n = 40 ) or an enhanced stretching exercise intervention ( n = 40 ) condition .


Both conditions received a 6 min stretching exercise program that included an orientation and three work-related musculoskeletal disorder ( WMSD ) educational classes .


Between educational classes , the enhanced stretching exercise condition also received mobile phone text messaging and telephone counseling to increase self-efficacy ( confidence in overcoming barriers ) and provide social support .


Flexibility , muscle strength , musculoskeletal symptoms , and acculturative stress were assessed at baseline and 12 weeks .


Significant increase in flexibility was noted for both conditions , but acculturative stress was significantly reduced only in the standard intervention condition .


Muscle strength and WMSD symptoms had no significant changes at the 12 week follow up in both conditions .


The 12 week , self-managed , community-based , stretching exercise program was effective to increase flexibility .


The standard stretching intervention without any enhancements may be a more cost-effective way to increase flexibility .


Longitudinal studies , however , are needed to see if the long-term effects are greater in the enhanced intervention for the migrant worker population .


To determine the effects of Syndrome Differentiated Chinese Medicine ( TCM ) Therapy on ( CKD ) 1-2 stage chronic kidney disease with proteinuria .


A prospective randomized control study was undertaken in 11 centers .


A total of 396 chronic nephritis patients were divided into a treatment group ( n = 297 ) and a control group ( n = 99 ) .


Their TCM syndrome was classified as `` Qi and Yin Deficiency of spleen and kidney '' or `` Qi and Yang Deficiency of spleen and kidney '' , with accompanying syndromes showing as `` water and dampness '' , `` damp-heat '' , and `` blood stasis '' .


Patients in the treatment group took a dose of Chinese medicine daily in response to their syndromes , while the controls took 50 mg/d losartan .


The course of treatment was 24 weeks .


Changes of 24-hour urinary protein excretion and glomerular filtration rate ( eGFR ) before and after treatments ( 4 , 8 , 12 , 16 , 20 , 24 weeks ) , as well as clinical efficacy ( after 4 , 16 , 24 weeks treatments ) were measured .


361 patients were included in the final program participants comply analysis ( PPS ) .


Patients in the treatment group showed gradual decreased 24-hour urinary protein excretion , whereas the controls remained unchanged .


Significant differences in 24-hour urinary protein excretion appeared between the experimental and control group at week 20 and 24 ( P < 0.05 ) .


eGFR decreased in all of the patients after treatments ( P = 0.0014 ) .


At three follow-up points , patients in the treatment group had higher eGFR than the controls , but without statistical significance ( P > 0.05 ) .


Significant differences in clinical remission rate , marked effect rate and total effective rate were observed between the treatment and control groups at week 24 ( P < 0.001 ) .


Syndrome differentiated TCM therapy can reduce the level of proteinuria in CKD 1-2 nephritis patients , promoting clinical effectiveness and protecting renal functions .


To evaluate the effects of oral delayed-release dimethyl fumarate ( DMF ; also known as gastro-resistant DMF ) on MRI lesion activity and load , atrophy , and magnetization transfer ratio ( MTR ) measures from the Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis ( CONFIRM ) study .


CONFIRM was a 2-year , placebo-controlled study of the efficacy and safety of DMF 240 mg twice ( BID ) or 3 times daily ( TID ) in 1,417 patients with relapsing-remitting multiple sclerosis ( RRMS ) ; subcutaneous glatiramer acetate 20 mg once daily was included as an active reference comparator .


The number and volume of T2-hyperintense , T1-hypointense , and gadolinium-enhancing ( Gd + ) lesions , as well as whole brain volume and MTR , were assessed in 681 patients ( MRI cohort ) .


DMF BID and TID produced significant and consistent reductions vs placebo in the number of new or enlarging T2-hyperintense lesions and new nonenhancing T1-hypointense lesions after 1 and 2 years of treatment and in the number of Gd + lesions at week 24 , year 1 , and year 2 .


Lesion volumes were also significantly reduced .


Reductions in brain atrophy and MTR changes with DMF relative to placebo did not reach statistical significance .


The robust effects on MRI active lesion counts and total lesion volume in patients with RRMS demonstrate the ability of DMF to exert beneficial effects on inflammatory lesion activity in multiple sclerosis , and support DMF therapy as a valuable new treatment option in RRMS .


This study provides Class I evidence of reduction in brain lesion number and volume , as assessed by MRI , over 2 years of delayed-release DMF treatment .


Percutaneous vertebroplasty is a widely used vertebral augmentation procedure for treating osteoporotic vertebral compression fractures ( OVCFs ) .


But high cement leakage rate caused by a low-viscosity cement and high injection pressure has limited its general use .


Balloon kyphoplasty ( BKP ) and high-viscosity cement vertebroplasty ( HVCV ) are 2 modifications of vertebroplasty designed to decrease cement leakage .


To assess the safety and efficacy of HVCV compared with BKP .


A prospective cohort study .


Department of Spine Surgery , an affiliated hospital of a medical university .


One hundred seven patients suffering from painful OVCFs were randomly assigned into HVCV or BKP groups .


Visual Analog Scale ( VAS ) , Oswestry Disability Index ( ODI ) , cement leakage , and vertebral height restoration were evaluated .


All occurring complications and injected cement volumes were recorded .


The follow-up time was one year .


VAS and ODI scores improved in both groups , and did not differ significantly between the 2 groups .


More cement was used in the BKP group than in HVCV group ( 4.22 vs. 3.31 mL , P < 0.0001 ) .


The incidence of cement leakage in the HVCV group was lower than that of the BKP group ( 13.24 % vs 30.56 % , P < 0.05 ) .


No symptomatic cement leakages occurred in the HVCV group .


In the BKP group , one patient experienced discogenic back pain related to a disc leak , and another patient had asymptomatic cement emboli in the lung related to venous leakage .


The mean compression rate before the procedure was 29.98 % in the HVCV group and 28.67 % in the BKP group ( P = 0.94 ) .


The vertebral height was improved significantly and maintained at one-year follow-up in both groups .


BKP was more effective in vertebral height restoration than HVCV ( 44.87 % vs. 23.93 % , P < 0.0001 ) .


There was one case of a new adjacent vertebral fracture in the HVCV group ( 2 % ) , and 4 cases of new nonadjacent vertebral fractures in the BKP group ( 7.84 % ) ( P = 0.18 ) .


A single-center and relatively small-sample size study .


HVCV and BKP are safe and effective in improving quality of life and relieving pain .


HVCV has a lower cement leakage rate , whereas BKP is more effective in vertebral height restoration .


Subsequent fractures are not different between the 2 groups .


This study aims to compare and evaluate the effect of adding ketamine as an adjunct to lidocaine for intravenous regional anesthesia ( IVRA ) on intraoperative and postoperative analgesia , the onset and recovery times of sensory and motor block , and tourniquet pain .


Forty patients undergoing surgery of the hand or forearm under IVRA were randomly assigned to receive lidocaine 3 mg/kg ( group 1 ) or lidocaine 3 mg/kg plus ketamine 50 mg ( group 2 ) diluted to 40 mL with normal saline .


Assessment parameters included the onset and recovery times of sensory and motor block , tourniquet pain , intraoperative hemodynamics , surgeon and patient satisfaction , postoperative pain , time of first analgesic request , total analgesic consumption , and adverse effects in the first 24 hours postoperatively .


Groups 1 and 2 were comparable in demographic and surgical parameters .


There were no differences between groups in intraoperative hemodynamics , onset and recovery times of sensory and motor block , or surgeon satisfaction index .


Compared with group 1 , group 2 patients showed less tourniquet pain , prolonged time to first request for postoperative rescue analgesia ( 5.5 1.3 vs 20.4 3.7 hours , P < 0.001 ) , lower postoperative diclofenac consumption ( 120.00 45.23 vs 55.1 0.00 mg , P < 0.001 ) , lower scores for postoperative pain as measured by the Verbal Rating Scale , higher patient satisfaction index , and a nonsignificant difference in the incidence of postoperative adverse effects between groups .


The addition of ketamine to lidocaine in patients receiving IVRA significantly reduced intraoperative and postoperative analgesic requirements and improved patient satisfaction without causing significant adverse effects .


Antiretroviral pre-exposure prophylaxis ( PrEP ) , with daily oral tenofovir disoproxil fumarate or tenofovir disoproxil fumarate in combination with emtricitabine , has been shown to be efficacious for HIV-1 prevention .


Although the use of more than one antiretroviral agent is essential for effective HIV-1 treatment , more than one agent might not be required for effective prophylaxis .


We assessed the efficacy of single-agent tenofovir disoproxil fumarate relative to combination emtricitabine plus tenofovir disoproxil fumarate as PrEP .


We did a randomised , double-blind , placebo-controlled three-group phase 3 trial of daily oral tenofovir disoproxil fumarate and emtricitabine plus tenofovir disoproxil fumarate PrEP in HIV-1 uninfected individuals in heterosexual HIV-1 serodiscordant couples from Kenya and Uganda .


After an interim review , the trial 's placebo group was discontinued and thereafter the active groups were continued , and participants initially randomly assigned to placebo were offered rerandomisation in a 1:1 ratio to tenofovir disoproxil fumarate or emtricitabine plus tenofovir disoproxil fumarate as PrEP .


The primary endpoints were HIV-1 seroconversion and safety .


This trial is registered with ClinicalTrials.gov , number NCT00557245 .


4410 ( 996 % ) of 4427 couples received tenofovir disoproxil fumarate or emtricitabine plus tenofovir disoproxil fumarate and were followed up for HIV-1 acquisition .


Of 52 incident HIV-1 infections , 31 occurred in individuals assigned tenofovir disoproxil fumarate ( incidence 071 cases per 100 person-years ) and 21 were in those assigned emtricitabine plus tenofovir disoproxil fumarate ( 048 cases per 100 person-years ) ; HIV-1 incidence in the placebo group until discontinuation was two cases per 100 person-years .


HIV-1 prevention efficacy with emtricitabine plus tenofovir disoproxil fumarate was not significantly different from that of tenofovir disoproxil fumarate alone ( hazard ratio [ HR ] 067 , 95 % CI 039-117 ; p = 016 ) .


Detection of tenofovir in plasma samples , compared with no detection and as measured in seroconverters and a subset of non-seroconverters , was associated with an 85 % relative risk reduction in HIV-1 acquisition for the tenofovir disoproxil fumarate group ( HR 015 , 95 % CI 006-037 ; p < 00001 ) and 93 % for the emtricitabine plus tenofovir disoproxil fumarate group ( 007 , 002-023 ; p < 00001 ) .


No significant differences were noted in the frequency of deaths , serious adverse events , or serum creatinine and phosphorus abnormalities between the two groups .


These results do not rule out the potential for a slight difference in HIV-1 protection with tenofovir disoproxil fumarate compared with emtricitabine plus tenofovir disoproxil fumarate , but show that once-daily oral tenofovir disoproxil fumarate or emtricitabine plus tenofovir disoproxil fumarate regimens both provide high protection against HIV-1 acquisition in heterosexual men and women .


Bill & Melinda Gates Foundation and US National Institutes of Health .


The safety of healthy volunteer donors is one of the most important issues in living-donor liver transplantation .


Use of the Pringle maneuver during donor hepatectomy can result in liver ischemia-reperfusion ( IR ) injury .


The objective of this study was to examine the effects of isoflurane and propofol on IR injury caused by the Pringle maneuver during donor hepatectomy .


A total of 70 American Society of Anesthesiology I-II donors aged 18-65 years who underwent hepatectomy were included in the study .


The patients were randomly divided into 2 groups : propofol and isoflurane .


Plasma superoxide dismutase ( SOD ) , malondialdehyde ( MDA ) , total oxidative status ( TOS ) , total antioxidant capacity ( TAC ) , and oxidative stress index ( OSI ) were measured before surgery ( t0 ) and after surgery ( t1 ) .


There were no statistically significant differences in demographic features , anesthesia , and times of surgery between the groups ( P > .05 ) .


Plasma TAC levels at t0 and t1 were significantly lower in the propofol group than in the isoflurane group ( P < .05 ) .


OSI at t1 was significantly higher in the propofol group than in the isoflurane group ( P < .05 ) .


MDA levels were significantly higher in the propofol group than in the isoflurane group at t0 ( P < .05 ) .


MDA levels level were significantly higher in the isoflurane group than in the propofol group at t1 ( P < .05 ) .


Propofol may have protective effects against IR injury caused by the Pringle maneuver during donor hepatectomy in living-donor transplantations .


However , the effectiveness of propofol for clinical use needs to be investigated further .


The aim of this study was to determine whether maternal vitamin supplementation affects long-term mortality and morbidity of children born to HIV-infected mothers .


In total , 1078 HIV-infected pregnant woman were enrolled in a double-blind , 22 factorial , randomised , placebo-controlled trial in Tanzania .


Data were collected for 874 children at monthly clinic visits through a median age of 51 months .


Maternal receipt of multivitamins ( HR = 0.93 ; 95 % CI : 0.70-1 .22 ) or vitamin A ( HR = 1.00 ; 95 % CI : 0.76-1 .32 ) did not affect all-cause child mortality through age 5 years .


Among HIV-negative children , maternal multivitamin supplementation was associated with a lower mortality rate up to 5 years ( HR = 0.60 ; 95 % CI : 0.38-0 .95 ) , primarily in children < 2 years of age .


Maternal vitamin A supplementation did not significantly affect child mortality up to 5 years ( HR = 0.76 ; 95 % CI : 0.48-1 .20 ) .


Children born to mothers who received multivitamins had a lower risk of all types of diarrhoea ( RR = 0.86 ; 95 % CI : 0.75-0 .98 ) through 5 years of age .


The reduced risk of watery diarrhoea persisted in children from 2-5 years of age ( RR = 0.71 ; 95 % CI : 0.54-0 .95 ) .


Maternal vitamin supplementation during pregnancy and lactation may be associated with long-lasting affects in HIV-exposed children [ ClinicalTrials.gov Identifier : NCT00197743 ] .


To investigate staff and trainer perspectives on the barriers and facilitators to implementing a complex intervention to help staff support the recovery of service users with a primary diagnosis of psychosis in community mental health teams .


Process evaluation nested within a cluster randomised controlled trial ( RCT ) .


28 interviews with mental health care staff , 3 interviews with trainers , 4 focus groups with intervention teams and 28 written trainer reports .


14 community-based mental health teams in two UK sites ( one urban , one semi-rural ) who received the intervention .


The factors influencing the implementation of the intervention can be organised under two over-arching themes : Organisational readiness for change and Training effectiveness .


Organisational readiness for change comprised three sub-themes : NHS Trust readiness ; Team readiness ; and Practitioner readiness .


Training effectiveness comprised three sub-themes : Engagement strategies ; Delivery style and Modelling recovery principles .


Three findings can inform future implementation and evaluation of complex interventions .


First , the underlying intervention model predicted that three areas would be important for changing practice : staff skill development ; intention to implement ; and actual implementation behaviour .


This study highlighted the importance of targeting the transition from practitioners ' intent to implement to actual implementation behaviour , using experiential learning and target setting .


Second , practitioners make inferences about organisational commitment by observing the allocation of resources , Knowledge Performance Indicators and service evaluation outcome measures .


These need to be aligned with recovery values , principles and practice .


Finally , we recommend the use of organisational readiness tools as an inclusion criteria for selecting both organisations and teams in cluster RCTs .


We believe this would maximise the likelihood of adequate implementation and hence reduce waste in research expenditure .


Controlled-Trials .


com ISRCTN02507940 .


This study aimed to compare emergence agitation following sevoflurane and desflurane anaesthesia in adults undergoing orthognathic surgery .


The hypothesis was that there might be a difference in the incidence of emergence agitation following sevoflurane and desflurane anaesthesia considering the difference in blood solubility and speed of recovery between the two .


In this prospective randomised double-blind study , 144 adults undergoing orthognathic surgery were randomly allocated to either sevoflurane or desflurane anaesthesia .


The incidence of emergence agitation and possible causative factors were then compared between the groups .


The incidence of emergence agitation was lower in the desflurane group than in the sevoflurane group ( 24 % vs. 71 % , P < 0.001 ) .


In addition , the time intervals between the discontinuation of anaesthetics and the first response , extubation , and discharge from post-anaesthesia care unit were significantly shorter in the desflurane group ( P = 0.002 , P < 0.001 and P = 0.003 , respectively ) .


The other variables were similar in the two groups .


In adults undergoing orthognathic surgery , desflurane anaesthesia was associated with less emergence agitation than was sevoflurane anaesthesia .


The aim of this study was to investigate the hypothesis that a novel biodegradable polymer-coated , cobalt-chromium ( CoCr ) , sirolimus-eluting stent ( BP-SES ) is noninferior in safety and efficacy outcomes compared with a durable polymer ( DP ) - SES .


No randomized trials have the compared safety and efficacy of BP-SES versus DP-SES on similar CoCr platforms , thereby isolating the effect of the polymer type .


In this prospective , single-blind , randomized trial conducted at 32 Chinese sites , 2,737 patients eligible for coronary stenting were treated with BP - or DP-SES in a 2:1 ratio .


The primary endpoint was 12-month target lesion failure ( TLF ) , a composite of cardiac death , target vessel myocardial infarction , or clinically indicated target lesion revascularization .


Secondary endpoints included TLF components , and definite/probable stent thrombosis .


At 12 months , the difference in the primary endpoint of TLF between BP-SES ( 6.3 % ) and DP-SES ( 6.1 % ) groups was 0.25 % ( 95 % confidence interval : -1.67 % to 2.17 % , p for noninferiority = 0.0002 ) , demonstrating noninferiority of BP-SES to DP-SES .


Individual TLF components of cardiac death ( 0.7 % vs. 0.6 % , p = 0.62 ) , target vessel myocardial infarction ( 3.6 % vs. 4.3 % , p = 0.39 ) , and clinically indicated target lesion revascularization ( 2.6 % vs. 2.2 % , p = 0.50 ) were similar , as were low definite/probable stent thrombosis rates ( 0.4 % vs. 0.6 % , p = 0.55 ) .


In this large-scale real-world trial , BP-SES was noninferior to DP-SES for 1-year TLF .


( Evaluate Safety and Effectiveness of the Tivoli DES and the Firebird DES for Treatment of Coronary Revascularization ; NCT01681381 ) .


Tinnitus , a subjective auditory perception of sounds or noise not triggered by external auditory stimuli , carries considerable morbidity .


To date , pharmacological , physical or behavioral therapy is the mainstay of management .


We compared repetitive transcranial magnetic stimulation ( rTMS ) of 1000 or 2000 stimulations/day at 1 Hz and 110 % of the motor threshold for 5 consecutive days over the left auditory cortex .


Ratings based on the Tinnitus Handicap Inventory ( THI ) rating scale were completed weekly for 4 weeks .


None of the patients had significant hearing impairment .


All 28 patients ( age range 21-72 ; 18 men ) tolerated rTMS well and no adverse effects were observed .


Analysis of variance ( ANOVA ) showed significant decrease in THI scores over the entire time period ( F ( 1,26 ) = 11.33 , p = 0.002 ) .


At every weekly time point of evaluation , ANOVA with repeated measures demonstrated significantly lower THI score compared to baseline ( p < 0.02 for all ) .


RTMS treatment had resulted in tinnitus reduction in the range of 15-25 % over the 4 week period .


Separately , ANOVA also demonstrated significantly reducing THI for both the 1000 pulse ( F ( 1,14 ) = 4.8 , p = 0.04 ) and 2000 pulse ( F ( 1,14 ) = 6.56 , p = 0.02 ) rTMS treatment arms .


Comparison of THI ratings between the 2 treatment arms did not result in significant difference ( F ( 1,26 ) = 1.48 , p = 0.24 ) .


The present study has revalidated the efficacy and safety of rTMS for improving tinnitus up to 4 weeks post-treatment in Asians .


However , there was no significant difference with THI evaluation between the 1000 pulse and 2000 pulse treatment arms .


To evaluate the impact of remote ischemic preconditioning ( RIPC ) on clinical outcome , biological markers of myocardial injury , and its safety in patients undergoing on-pump coronary artery bypass grafting ( CABG ) .


This study was conducted at Ch .


Pervaiz Elahi Institute of Cardiology ( CPEIC ) in Multan .


The study took place from March 2012 to June 2013 .


Patients were randomly placed into two groups .


Group A ( N = 32 ) did not undergo RIPC ; Group B ( N = 35 ) received RIPC after induction of anesthesia .


Similar standard general anesthesia , cardiopulmonary technique , myocardial protection strategies , and surgical techniques were used in both groups except the protocol for RIPC .


Following postoperative outcome , i.e. cardiac defibrillation after removal of aortic cross clamp during the period of rewarming , demand for intra-aortic balloon pump ( IABP ) , demand for antiarrhythmic before leaving the operation room , postoperative creatine kinase-myocardial band ( CK-MB ) level ( at 1h , 12h , 24h , and 48h after surgery ) , postoperative serum creatinine level on first postoperative day , postoperative ejection fraction ( EF ) on third postoperative day , in-hospital mortality , and one-year mortality were noted , prospectively .


Safety of protocol of RIPC was estimated by limb ischemia monitored by pulse oximetry during and after procedure of RIPC and postoperative neurapraxia by nerve examination of right upper limb .


Post aortic cross clamp release cardiac defibrillation , demand for IABP , demand for high inotropes , and use of antiarrhythmic in the operation room were statistically insignificant in the non-RIPC and RIPC group with P values of .54 , .78 , .16 , and .16 , respectively .


Mean postoperative CK-MB level ( IU/L ) showed the following results : At 1h ( Group A 20.94 + 1.66 , Group B 20.57 + 1.54 , P = .35 ) , at 12h ( Group A 27.13 + 1.85 , Group B 28.05 + 3.04 , P = .135 ) , at 24h ( Group A 27.63 + 1.7 , Group B 27.85 + 2.2 , P = .63 ) , and at 48h ( Group A 22.95 + 2.76 , Group B 23.27 + 3.6 , P = .69 ) .


First postoperative day serum creatinine ( Group A 1.29 + 0.395 , Group B 1.33 + 0.57 , P = .77 ) and postoperative ejection fraction percentage on the third postoperative day ( Group A 50.78 + 8.72 , Group B 50.57 + 8.38 , P = .92 ) showed no statistical difference between two groups .


Postoperative low cardiac output state , in-hospital mortality , and one-year mortality also were statistically insignificant between the groups with P values of .93 , .29 , and .33 , respectively .


None of the patients in either group showed evidence of limb ischemia and neurapraxia of the right upper limb .


RIPC is a safe technique , but it does not have additional clinical benefit after on-pump CABG surgery in the presence of a standard myocardial protective strategy .


Topical tretinoin is commonly prescribed , but its frequent adverse effects are barriers to use .


Predictors of resistance or susceptibility to retinoid irritation are not known .


To identify baseline patient characteristics associated with adverse effects of topical tretinoin .


This cohort study used data collected from 324 participants in the Veterans Affairs Topical Tretinoin Chemoprevention trial who were randomized to apply tretinoin cream on the face and ears .


Univariate and multivariate logistic regression models were used to examine the associations between baseline characteristics and local adverse effects .


One hundred and ninety-seven patients ( 61 % of those randomized to tretinoin ) reported local adverse effects within 6 months .


Clinical signs of severe photodamage at baseline [ odds ratio ( OR ) 015 , 95 % confidence interval ( CI ) 004-054 ] and history of acne ( OR 046 , 95 % CI 027-077 ) were associated with a decreased risk of adverse effects to tretinoin .


The use of other topical medications at enrolment ( OR 188 , 95 % CI 115-308 ) predicted an increase in adverse effects .


In this study population , the common indications of topical tretinoin treatment were associated with lower risks of adverse effects .


The concurrent use of other topical medications may worsen irritation caused by tretinoin .


Between 75000 and 125000 U.S. infants are hospitalized for respiratory syncytial virus ( RSV ) bronchiolitis every year .


Up to half will be diagnosed with asthma in later childhood .


Vitamin D deficiency has been associated with susceptibility to asthma and respiratory infections .


Measured vitamin D is largely bound to vitamin D-binding protein ( VDBP ) ; VDBP levels are influenced by its gene ( GC ) haplotype .


We assessed the relationship between polymorphisms rs7041 and rs4588 , which define haplotypes GC1s , GC1f , and GC2 , and RSV bronchiolitis susceptibility and subsequent asthma .


We retrospectively recruited 198 otherwise healthy children ( 93 % White ) hospitalized for severe RSV bronchiolitis in Boston and 333 parents into a follow-up study to assess asthma diagnosis .


Data were analysed using family-based genetic association tests .


We independently validated our results in 465 White children hospitalized with RSV bronchiolitis and 930 White population controls from the Netherlands .


The rs7041_C allele ( denoting haplotype GC1s ) was overtransmitted ( P = 0.02 , additive model ) in the entire Boston cohort , in Whites ( P = 0.03 ) , and especially in children subsequently diagnosed with asthma ( P = 0.006 ) .


The GC1f haplotype was undertransmitted in the asthma subgroups ( all races and White , both P < 0.05 ) .


The rs7041_C allele was also more frequent in the RSV bronchiolitis group compared with controls ( OR 1.12 , 95 % CI 1.02 , 1.4 , P = 0.03 ) in the Netherlands , especially in mechanically ventilated patients ( P = 0.009 ) .


GC1s haplotype carriage may increase the risk of RSV bronchiolitis in infancy and subsequent asthma development .


The GC1s haplotype is associated with higher VDBP levels , resulting in less freely available vitamin D.


Vitamin D-binding protein ( VDBP ) haplotypes influence free vitamin D levels .


We report an association between a VDBP haplotype and hospitalization for RSV bronchiolitis in infancy in two independent cohorts .


Psycho-educational interventions for people diagnosed with schizophrenia ( PDwS ) and their primary caregivers appear promising , however , the majority of trials have significant methodological shortcomings .


There is little known about the effects of these interventions delivered in a booklet format in resource-poor countries .


A randomized controlled trial was conducted from September , 2012 to July , 2013 with 121 dyads of PDwS and their primary caregivers .


Participants aged 18 years or older with DSM-IV schizophrenia or schizoaffective disorder , and their primary caregivers , from four outpatient mental health clinics in Jordan , were randomly assigned to receive 12 weeks of a booklet form of psycho-education , with follow-up phone calls , and treatment as usual [ TAU ] ( intervention , n = 58 ) , or TAU ( control , n = 63 ) .


Participants were assessed at baseline , immediately post-intervention ( post-treatment1 ) and at three months follow-up .


The primary outcome measure was change in knowledge of schizophrenia .


Secondary outcomes for PDwS were psychiatric symptoms and relapse rate , with hospitalization or medication ( number of episodes of increasing antipsychotic dosage ) , and for primary caregivers were burden of care and quality of life .


PDwS in the intervention group experienced greater improvement in knowledge scores ( 4.9 vs -0.5 ; p < 0.001 ) at post-treatment and ( 6.5 vs -0.7 ; p < 0.001 ) at three month-follow-up , greater reduction in symptom severity ( -26.1 vs 2.5 ; p < 0.001 : -36.2 vs -4.9 ; p < 0.001 , at follow-up times respectively .


Relapse rate with hospitalization was reduced significantly at both follow-up times in the intervention group ( p < 0.001 ) , and relapse with medication increased in the intervention group at both follow-up times ( p < 0.001 ) .


Similarly there was a significant improvement in the primary caregivers knowledge score at post-treatment ( 6.3 vs -0.4 ; P < 0.001 ) and three month-follow-up ( 7.3 vs -0.7 ; p < 0.001 ) .


Primary caregivers burden of care was significantly reduced in the intervention group ( -6.4 vs 1.5 ; p < 0.001 ; -9.4 vs 0.8 ; p < 0.001 ) , and their quality of life improved ( 9.2 vs -1.6 ; p = 0.01 ; 17.1 vs -5.3 ; p < 0.001 ) at post-treatment and three month-follow-up .


Psycho-education and TAU was more effective than TAU alone at improving participants ' knowledge and psychological outcomes .


Current Controlled Trials ISRCTN78084871 .


The purpose of this study was to evaluate the efficacy of osteopathic manipulative treatment ( OMT ) to reduce low back pain and improve functioning during the third trimester in pregnancy and to improve selected outcomes of labor and delivery .


Pregnancy research on osteopathic manipulation optimizing treatment effects was a randomized , placebo-controlled trial of 400 women in their third trimester .


Women were assigned randomly to usual care only ( UCO ) , usual care plus OMT ( OMT ) , or usual care plus placebo ultrasound treatment ( PUT ) .


The study included 7 treatments over 9 weeks .


The OMT protocol included specific techniques that were administered by board-certified OMT specialists .


Outcomes were assessed with the use of self-report measures for pain and back-related functioning and medical records for delivery outcomes .


There were 136 women in the OMT group : 131 women in the PUT group and 133 women in the UCO group .


Characteristics at baseline were similar across groups .


Findings indicate significant treatment effects for pain and back-related functioning ( P < .001 for both groups ) , with outcomes for the OMT group similar to that of the PUT group ; however , both groups were significantly improved compared with the UCO group .


For secondary outcome of meconium-stained amniotic fluid , there were no differences among the groups .


OMT was effective for mitigating pain and functional deterioration compared with UCO ; however , OMT did not differ significantly from PUT .


This may be attributed to PUT being a more active treatment than intended .


There was no higher likelihood of conversion to high-risk status based on treatment group .


Therefore , OMT is a safe , effective adjunctive modality to improve pain and functioning during the third trimester .


Atrial fibrillation ( AF ) is the most common sustained cardiac arrhythmia imposing substantial morbidity and mortality .


Catheter-based pulmonary vein isolation ( PVI ) using radiofrequency current ( RFC ) has become a standard treatment for drug-resistant and symptomatic paroxysmal AF ( PAF ) .


In recent years , the cryoballoon-based technique is increasingly used as a promising alternative with a short learning curve .


The FIRE AND ICE trial is a prospective , randomized , controlled , open , blinded outcome assessment , noninferiority trial comparing cryoballoon - , and RFC-based PVI .


Patients with drug-resistant PAF will be randomized in a 1:1 matrix in multiple European centers .


The primary hypothesis is that cryoballoon ablation is not inferior to RFC ablation using 3-dimensional mapping with respect to clinical efficacy .


The primary endpoint is defined as the time to first documented clinical failure , including : ( 1 ) recurrence of AF ; ( 2 ) atrial flutter or atrial tachycardia ; ( 3 ) prescription of class I or III antiarrhythmic drugs ; or ( 4 ) re-ablation , whichever comes first , following a blanking period of 3 months after the index ablation procedure .


The primary safety endpoint is a composite of death , stroke/transient ischemic attack , cardiac arrhythmias ( apart from AF recurrence ) causally related to the therapeutic intervention , and procedure-related serious adverse events .


The FIRE AND ICE trial compares 2 different technologies to perform catheter ablation of PAF with respect to efficacy and safety .


It aims at providing objective data to guide selection and usage of ablation catheters in the treatment of AF .


As pulmonary arterial hypertension ( PAH ) is associated with significant morbidity and mortality , particularly among patients with right ventricular ( RV ) dysfunction , we aimed to determine the impact of therapy to reduce pulmonary vascular resistance ( PVR ) on RV and LV deformation in PAH .


Right ventricular free wall longitudinal strain ( FWLS ) and LV global circumferential strain ( CS ) were measured at baseline , 12 weeks , and 24 weeks in 68 patients with advanced PAH randomized to imatinib or placebo in the Imatinib in Pulmonary arterial hypertension , a Randomized Efficacy Study ( IMPRES ) trial , and compared with 30 healthy controls .


Compared with controls , PAH was associated with impaired RV FWLS ( -15.95.4 vs. -30.84.3 , respectively ; P < 0.0001 ) and LV septal CS ( -24.28.2 vs. -31.45.3 , respectively , P < 0.0001 ) , but not LV global CS .


Improvement in PVR and mean pulmonary artery pressure ( MPAP ) over a 24-week period was significantly associated with improvement in RV FWLS ( r = 0.39 , P = 0.02 ; 0.33 , P = 0.04 respectively ) , LV global CS ( r = 0.61 , P = 0.0001 ; r = 0.60 , P = 0.0001 , respectively ) , and LV septal CS ( r = 0.50 , P = 0.005 ; r = 0.56 , P = 0.002 , respectively ) .


These associations were most robust with LV global and septal CS .


Imatinib therapy was associated with improvement in RV FWLS compared with placebo .


PAH is associated with impaired biventricular deformation .


Reduction in PVR is associated with improvements in both RV and LV deformation , coupled to improvements in MPAP and stroke volume index , with LV global and septal CS the strongest correlates of these changes .


RV FWLS is sensitive to treatment effect , demonstrating greater improvement with imatinib compared with placebo .


NCT00902174 .


The aim of the study was to test the antiviral efficacy of a triple nucleoside reverse transcriptase inhibitor ( NRTI ) regimen , with potential beneficial metabolic effects , as maintenance therapy after induction with dual NRTIs and a boosted protease inhibitor ( PI ) .


An open-label , noninferiority study was carried out .


Antiretroviral therapy ( ART ) - nave patients with CD4 count 350 cells/L and HIV-1 RNA > 30000 copies/mL ( n = 207 ) were treated with zidovudine/lamivudine and lopinavir/ritonavir .


After achieving HIV-1 RNA < 50 copies/mL on two consecutive occasions between weeks 12 and 24 after baseline , 120 patients ( baseline : median HIV-1 RNA 5.19 log10 copies/mL ; median CD4 count 180 cells/L ) were randomized to receive abacavir/lamivudine/zidovudine ( ABC/3TC/ZDV ) ( n = 61 ) or to continue the PI-based ART ( n = 59 ) .


For the proportions of patients ( intention-to-treat ; missing = failure ) with HIV-1 RNA < 400 copies/mL ( PI group , 66 % ; ABC/3TC/ZDV group , 71 % ) and < 50 copies/mL ( PI group , 63 % ; ABC/3TC/ZDV group , 62 % ) at 96 weeks , switching to ABC/3TC/ZDV was noninferior compared with continuing the PI regimen ; the difference in failure rate ( ABC/3TC/ZDV minus PI ) was -4.4 percentage points [ 95 % confidence interval ( CI ) -21.0 to +12.3 percentage points ] and +0.4 percentage points ( 95 % CI -16.9 to +17.7 percentage points ) , respectively .


In the per protocol analysis , the difference in virological failure for HIV-1 RNA > 400 copies/mL ( 0 of 39 patients in the PI group and two of 45 patients in the NRTI group ) and for HIV-1 RNA > 50 copies/mL ( two of 39 and three of 45 patients , respectively ) was +4.4 percentage points ( 95 % CI -2.1 to +11.0 percentage points ) and +1.5 percentage points ( 95 % CI -8.6 to +11.7 percentage points ) , respectively , also showing noninferiority .


Serum lipids significantly improved in the NRTI group , but not in the PI arm .


A single-class NRTI regimen after successful induction with standard ART had similar antiviral efficacy compared to continuation of a PI-based regimen at 96 weeks after baseline , with improved serum lipids .


Multi drug resistant-tuberculosis ( MDR-TB ) [ resistant to Isoniazid and Rifampicin ] is a major global public health problem .


In India the incidence is rising in spite of implementation of Revised National Tuberculosis Control Program .


Standard MDR-TB drugs are second generation antibiotics taken for 24-27 months .


The present study was undertaken to evaluate the efficacy of add on homeopathic intervention to the standard MDR-TB regimen ( SR ) .


A randomized , double blind , placebo controlled study was conducted from 2003 to 2008.120 diagnosed MDR-TB patients ( both culture positive and negative ) were enrolled and randomized to receive Standard Regimen + individualized homeopathic medicine ( SR+H ) or Standard Regimen + identical placebo ( SR+P ) .


The medicines have been used in infrequent doses .


The outcome measures were sputum conversion , changes in chest X-ray ( CXR ) , hemoglobin , erythrocyte sedimentation rate ( ESR ) , weight gain , and clinical improvement .


There was an improvement in all the outcome measures as per intention to treat ( ITT ) and per protocol ( PP ) analyses .


ITT analyses revealed sputum culture conversion from positive to negative in 23 ( 38.3 % ) in SR+H ; 23 ( 38.3 % ) patients in SR+P group ; ( p = 0.269 ) and 27 ( 55.1 ) ; 21 ( 42.8 % ) , p = 0.225 as PP analyses .


The mean weight gain in SR+H group was 2.44.9 and in SR+P was 0.84.4 ; [ p = 0.071 ] , reduction in ESR in SR+H was -8.713.2 ; SR+P was 3.915.4 [ p = 0.068 ] .


The mean increase in hemoglobin was by 0.61.7 in SR+H & 0.32.3 [ p = 0.440 ] in SR+P group at 95 % confidence interval .


Statistically significant improvement was seen in CXR in 37 ( 61.7 % ) in SR+H and 20 ( 33.3 % ) patients in SR+P group ( p = 0.002 ) .


Subgroup analyses of culture positive patients showed statistically significant improvement in CXR ( p = 0.0005 ) , weight gain ( p = 0.026 ) , increase in hemoglobin ( p = 0.017 ) and reduction in ESR ( p = 0.025 ) with add on homeopathy .


The cure rate was 11.4 % more in SR+H group as compared to placebo group .


Change in sputum culture conversion , was not statistically significant .


Add on homeopathy in addition to standard therapy appears to improve outcome in MDR-TB .


Larger scale studies using a standardized homeopathic treatment regime should be conducted .


In youth , both waterpipe tobacco smoking ( WTS ) and nonmedical use of prescription drugs ( NMUPD ) are globally growing concerns .


This study assesses for the first time the lifetime and past-year associations between WTS and four classes of psychoactive prescription drugs .


Cross-sectional data ( 2011 ) on 986 high school students attending public and private high schools in Beirut ( Lebanon ) was analyzed .


Schools were selected using proportionate random cluster sampling from a comprehensive list of schools provided by the Ministry of Education .


Almost half ( 46 % ) had tried WTS compared to 25 % who had ever tried cigarettes .


Lifetime prevalence estimates of NMUPD were : pain relievers ( 8.2 % ) , sedatives/tranquilizers ( 5.6 % ) , stimulants ( 3.5 % ) , antidepressants ( 2.5 % ) , and sleeping pills ( 2.3 % ) .


WTS was associated with increased odds of sedatives/tranquilizer use ( OR = 3.22 , 95 % CI : 1.25 , 8.25 ) , pain reliever use ( OR = 4.31 , 95 % CI : 2.02 , 9.17 ) , and sleeping medication use ( OR = 8.31 , 95 % CI : 2.37 , 29.20 ) , controlling for sex , age , school type , and other substance use .


For cigarettes , the associations were consistently either weaker or non-existent , except with stimulant use ( OR = 5.29 , 95 % CI : 1.55 , 18.05 ) .


While public health professionals have watched with caution the global prevalence of youth cigarette use-worldwide , an insidious alternative form of tobacco use has grown .


Further research is needed to understand the unique risk factors and motives associated with WTS and how these relate to NMUPD in order to inform the development of effective intervention programs and policies that support youth positive health decisions .


Vaccine effectiveness of pneumococcal conjugate vaccines against culture-confirmed invasive pneumococcal disease has been well documented .


In the Finnish Invasive Pneumococcal disease ( FinIP ) trial , we reported vaccine effectiveness and absolute rate reduction against laboratory-confirmed invasive pneumococcal disease ( confirmation by culture or antigen or DNA detection irrespective of serotype ) .


Here , we assessed vaccine effectiveness of PHiD-CV10 against clinically suspected invasive pneumococcal disease in children by use of diagnoses coded in hospital discharge registers .


For this phase 3/4 cluster-randomised , double-blind trial , undertaken between Feb 18 , 2009 , and Dec 31 , 2011 , in municipal health-care centres and the Tampere University Vaccine Research Centre ( Finland ) , we randomly assigned ( 2:2:1:1 ) 78 clusters into PHiD-CV10 three plus one , PHiD-CV10 two plus one , control three plus one , control two plus one groups ( 26:26:13:13 clusters ) to give PHiD-CV10 in either three plus one or two plus one schedule ( if enrolled before 7 months of age ; infant schedules ) , two plus one ( if enrolled between 7 and 11 months ; catch-up schedules ) , and two doses at least 6 months apart ( if enrolled between 12 and 18 months ; catch-up schedules ) .


Children were eligible if they had not received and were not anticipated to receive any of the study vaccines and had no general contraindications to vaccinations .


We collected all inpatient and outpatient discharge notifications from the national hospital discharge register with International Classification of Diseases ( ICD ) 10 diagnoses compatible with invasive pneumococcal disease or unspecified sepsis , and verified data with patient files .


We excluded invasive pneumococcal disease cases confirmed by positive culture or DNA/RNA detection from normally sterile body fluid .


The primary objective was to estimate vaccine effectiveness against all register-based non-laboratory-confirmed invasive pneumococcal disease or unspecified sepsis and patient-file verified non-laboratory-confirmed invasive pneumococcal disease in infants younger than 7 months at enrolment .


Masked follow-up lasted from the date of the first vaccination to Dec 31 , 2011 .


Vaccine effectiveness was calculated against all episodes .


This trial is registered with ClinicalTrials.gov , numbers NCT00861380 and NCT00839254 .


We enrolled 47,366 children .


On the basis of ICD-10 diagnoses , we recorded 264 episodes of register-based non-laboratory-confirmed invasive pneumococcal disease or unspecified sepsis , of which 102 were patient-file verified non-laboratory-confirmed invasive pneumococcal disease .


The vaccine effectiveness was 50 % ( 95 % CI 32-63 ) in the 30,527 infants with three plus one and two plus one schedules combined and the absolute incidence rate reduction was 207 episodes per 100,000 person-years ( 95 % CI 127-286 ) .


The vaccine effectiveness against the patient-file verified non-laboratory-confirmed invasive pneumococcal disease was 71 % ( 95 % CI 52-83 ) in infant three plus one and two plus one schedules combined .


The absolute rate reduction was 142 episodes per 100,000 person-years ( 95 % CI 91-191 ) in infant cohorts .


This vaccine-probe analysis is the first report showing the effect of pneumococcal conjugate vaccines on clinically suspected invasive pneumococcal disease .


The absolute rate reduction was markedly higher compared with laboratory-confirmed invasive pneumococcal disease , which implies low sensitivity of the laboratory-based case definitions and subsequently higher public health effect of pneumococcal conjugate vaccines against invasive pneumococcal disease than previously estimated .


GlaxoSmithKline Biologicals SA and National Institute for Health and Welfare ( THL ) , Finland .


Communication problems impede effective symptom management during chemotherapy .


The primary aim of this pilot randomized controlled trial was to test the effects of a personal digital assistant-delivered communication intervention on pain , depression , and fatigue symptoms among breast cancer patients undergoing chemotherapy .


Secondary aims included assessment of 1 ) study feasibility , 2 ) patient and clinician responses to study participation , and 3 ) intervention effects on health-related quality of life ( HRQoL ) and communication self-efficacy .


Intervention group participants ( n = 27 ) completed symptom inventories at baseline , once per week during treatment , and at posttreatment .


Depending on symptom severity , they viewed race-concordant videos on how to communicate about pain , depression and/or fatigue , using the personal digital assistant .


Symptom records were tracked and shared with clinicians .


Control group participants ( n = 23 ) received usual care .


Longitudinal random effects modeling assessed the changes in average symptom scores over time .


Descriptive statistics assessed study feasibility and intervention effects on HRQoL and communication self-efficacy .


Postintervention focus groups , interviews , and surveys assessed responses to study participation .


Mean age of the participants was 51.0 years ; 42 participants ( 84 % ) were white .


In comparison with control , intervention group participants reported lower average pain severity over time ( P = .015 ) .


Mean pain interference scores over time were marginally different between groups ( P = .07 ) ; mean depression and fatigue scores over time were statistically nonsignificant .


Feasibility outcomes and perspectives about study participation were positive .


Mean pre-post decreases in HRQoL were generally higher among intervention group participants ; pre-post changes in communication self-efficacy were equivalent .


Mixed findings of the study indicate the need for future research .


The resynchronization-defibrillation for ambulatory heart failure trial ( RAFT ) study demonstrated that adding cardiac resynchronization therapy ( CRT ) in selected patients requiring de novo implantable cardiac defibrillators ( ICD ) reduced mortality as compared with ICD therapy alone , despite an increase in procedure-related adverse events .


Data are lacking regarding the management of patients with ICD therapy who develop an indication for CRT upgrade .


Participating RAFT centers provided data regarding de novo CRT-D ( CRT with ICD ) implant , upgrade to CRT-D during RAFT ( study upgrade ) , and upgrade within 6 months after presentation of study results ( substudy ) .


Substudy centers enrolled 1346 ( 74.9 % ) patients in RAFT , including 644 de novo , 80 study upgrade , and 60 substudy CRT attempts .


The success rate ( initial plus repeat attempts ) was 95.2 % for de novo versus 96.3 % for study upgrade and 90.0 % for substudy CRT attempts ( P = 0.402 ) .


Acute complications occurred among 26.2 % of de novo versus 18.8 % of study upgrade and 3.4 % of substudy CRT implantation attempts ( P < 0.001 ) .


The most common complication was left ventricular lead dislodgement .


The principal reasons for not yet attempting upgrade in the substudy were patient preference ( 31.9 % ) , New York Heart Association Class I ( 17.0 % ) , and a QRS < 150 ms ( 13.1 % ) .


Among a broad group of implant physicians , CRT upgrades were performed in patients with an ICD in situ with no difference in implant success rate and a reduced acute complication rate as compared with a de novo CRT implant .


Decisions to upgrade were influenced by predictors of benefit in subgroup analyses of the RAFT study and other trials .


Military deployment can have profound effects on physical and mental health .


Few studies have examined whether interventions prior to deployment can improve mechanisms underlying resilience .


Mindfulness-based techniques have been shown to aid recovery from stress and may affect brain-behavior relationships prior to deployment .


The authors examined the effect of mindfulness training on resilience mechanisms in active-duty Marines preparing for deployment .


Eight Marine infantry platoons ( N = 281 ) were randomly selected .


Four platoons were assigned to receive mindfulness training ( N = 147 ) and four were assigned to a training-as-usual control condition ( N = 134 ) .


Platoons were assessed at baseline , 8 weeks after baseline , and during and after a stressful combat training session approximately 9 weeks after baseline .


The mindfulness training condition was delivered in the form of 8 weeks of Mindfulness-Based Mind Fitness Training ( MMFT ) , a program comprising 20 hours of classroom instruction plus daily homework exercises .


MMFT emphasizes interoceptive awareness , attentional control , and tolerance of present-moment experiences .


The main outcome measures were heart rate , breathing rate , plasma neuropeptide Y concentration , score on the Response to Stressful Experiences Scale , and brain activation as measured by functional MRI .


Marines who received MMFT showed greater reactivity ( heart rate [ d = 0.43 ] ) and enhanced recovery ( heart rate [ d = 0.67 ] , breathing rate [ d = 0.93 ] ) after stressful training ; lower plasma neuropeptide Y concentration after stressful training ( d = 0.38 ) ; and attenuated blood-oxygen-level-dependent signal in the right insula and anterior cingulate .


The results show that mechanisms related to stress recovery can be modified in healthy individuals prior to stress exposure , with important implications for evidence-based mental health research and treatment .


Malignant pleural effusion can complicate most cancers .


It causes breathlessness and requires hospitalisation for invasive pleural drainages .


Malignant effusions often herald advanced cancers and limited prognosis .


Minimising time spent in hospital is of high priority to patients and their families .


Various treatment strategies exist for the management of malignant effusions , though there is no consensus governing the best choice .


Talc pleurodesis is the conventional management but requires hospitalisation ( and substantial healthcare resources ) , can cause significant side effects , and has a suboptimal success rate .


Indwelling pleural catheters ( IPCs ) allow ambulatory fluid drainage without hospitalisation , and are increasingly employed for management of malignant effusions .


Previous studies have only investigated the length of hospital care immediately related to IPC insertion .


Whether IPC management reduces time spent in hospital in the patients ' remaining lifespan is unknown .


A strategy of malignant effusion management that reduces hospital admission days will allow patients to spend more time outside hospital , reduce costs and save healthcare resources .


The Australasian Malignant Pleural Effusion ( AMPLE ) trial is a multicentred , randomised trial designed to compare IPC with talc pleurodesis for the management of malignant pleural effusion .


This study will randomise 146 adults with malignant pleural effusions ( 1:1 ) to IPC management or talc slurry pleurodesis .


The primary end point is the total number of days spent in hospital ( for any admissions ) from treatment procedure to death or end of study follow-up .


Secondary end points include hospital days specific to pleural effusion management , adverse events , self-reported symptom and quality-of-life scores .


The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study as have the ethics boards of all the participating hospitals .


The trial results will be published in peer-reviewed journals and presented at scientific conferences .


Australia New Zealand Clinical Trials Registry-ACTRN12611000567921 ; National Institutes of Health-NCT02045121 .


The pulsatile secretion pattern of growth hormone ( GH ) is an important parameter of GH action at peripheral tissues , and more information is needed on how exercise impacts GH secretion .


This study hypothesized that both aerobic and resistance exercise would exhibit dose-response relationships with respect to exercise duration and 20-h postexercise GH secretion .


Eight healthy men randomly completed five separate conditions : 1 ) control ( no exercise ; CON ) , 2 ) a moderate-duration ( 1-h ) aerobic exercise session ( MA ) , 3 ) a long-duration ( 2-h ) aerobic exercise session ( LA ) , 4 ) a moderate-duration ( 1-h ) resistance exercise session ( MR ) , and 5 ) a long-duration ( 2-h ) resistance exercise session ( LR ) .


Exercise intensity , diet , sleep , and physical activity were strictly controlled during each condition , and blood was sampled postexercise every 20 min for 20 h , and GH secretion parameters were analyzed via cluster and deconvolution analyses .


Only the 2-h aerobic exercise bout resulted in a significant amplification of GH secretion as evidenced by increases in GH burst peak amplitude ( 100 % ) , basal GH secretion rate ( 127 % ) , total GH basal secretion ( 120 % ) , total pulsatile secretion ( 88 % ) , and total GH secretion ( 89 % ) over the control ( i.e. , no exercise ) condition .


GH secretions for the resistance exercise conditions were not different from control .


The fact that the 2-h aerobic exercise condition resulted in higher energy expenditure than the other exercise conditions could offer a partial explanation for the greater GH amplification because of the metabolic effects that GH exerts in stimulating postexercise lipolysis .


We conclude that extending the duration of aerobic exercise , but not resistance exercise , from 1 - to 2-h significantly amplifies GH secretion during a 20-h period .


To compare the effective of short-segment pedicle instrumentation with bone grafting and pedicle screw implanting in injured vertebra and cross segment pedicle instrumentation with bone grafting in injured vertebra for treating thoracolumbar fractures .


A prospective randomized controlled study was performed in 40 patients with thoracolumbar fracture who were in accordance with the inclusive criteria between June 2010 and June 2012 .


Of 40 patients , 20 received treatment with short-segment pedicle screw instrumentation with bone grafting and pedicle screw implanting in injured vertebra in group A , and 20 received treatment with cross segment pedicle instrumentation with bone grafting in injured vertebra in group B.


There was no significant difference in gender , age , affected segment , disease duration , Frankel grade , Cobb angle , compression rate of anterior verterbral height , visual analogue scale ( VAS ) score , and Japanese Orthopaedic Association ( JOA ) score between 2 groups before operation ( P > 0.05 ) .


The operation time , blood loss , Cobb angle , compression rate of anterior vertebral height , loss of disc space height , Frankel grade , VAS and JOA scores were compared between 2 groups .


There was no significant difference in the operation time and blood loss between 2 groups ( P > 0.05 ) .


Primary healing of incision was obtained in all patients , and no early complication of infection or lower limb vein thrombus occurred .


Forty patients were followed up 12-16 months ( mean , 14.8 months ) .


No breaking or displacement of internal fixation was observed .


The improvement of Frankel grading score was 0.52 + / - 0.72 in group A and 0.47 + / - 0.63 in group B , showing no significant difference ( t = 0.188 , P = 0.853 ) at 12 months after operation .


The Cobb angle , compression rate of anterior verterbral height , and VAS score at 1 week and 12 months , and JOA score at 12 months were significantly improved when compared with preoperative ones in 2 groups ( P < 0.05 ) .


No significant difference was found in Cobb angle , disc space height , VAS score , and JOA score between 2 groups at each time point ( P > 0.05 ) , but the compression rate of anterior verterbral height in group A was significantly lower than that in group B ( P < 0.05 ) .


The loss of disc space height next to the internal fixation or the injured vertebra was observed in 2 groups at 12 months , but showing no significant difference ( P > 0.05 ) .


Compared with cross segment pedicle instrumentation , short-segment pedicle screw instrumentation with bone grafting and pedicle screw implanting in injured vertebra can recover and maintain the affected vertebra height in treating thoracolumbar fractures , but it could not effectively prevent degeneration of adjacent segments and the loss of kyphosis correction degree .


To evaluate the effect of a novel divided attention task-walking under auditory constraints-on gait performance in older adults and to determine whether this effect was moderated by cognitive status .


Validation cohort .


General community .


Ambulatory older adults without dementia ( N = 104 ) .


Not applicable .


In this pilot study , we evaluated walking under auditory constraints in 104 older adults who completed 3 pairs of walking trials on a gait mat under 1 of 3 randomly assigned conditions : 1 pair without auditory stimulation and 2 pairs with emotionally charged auditory stimulation with happy or sad sounds .


The mean age of subjects was 80.64.9 years , and 63 % ( n = 66 ) were women .


The mean velocity during normal walking was 97.920.6 cm/s , and the mean cadence was 105.19.9 steps/min .


The effect of walking under auditory constraints on gait characteristics was analyzed using a 2-factorial analysis of variance with a 1-between factor ( cognitively intact and minimal cognitive impairment groups ) and a 1-within factor ( type of auditory stimuli ) .


In both happy and sad auditory stimulation trials , cognitively intact older adults ( n = 96 ) showed an average increase of 2.68 cm/s in gait velocity ( F1 .86,191.71 = 3.99 ; P = .02 ) and an average increase of 2.41 steps/min in cadence ( F1 .75,180.42 = 10.12 ; P < .001 ) as compared with trials without auditory stimulation .


In contrast , older adults with minimal cognitive impairment ( Blessed test score , 5-10 ; n = 8 ) showed an average reduction of 5.45 cm/s in gait velocity ( F1 .87,190.83 = 5.62 ; P = .005 ) and an average reduction of 3.88 steps/min in cadence ( F1 .79,183.10 = 8.21 ; P = .001 ) under both auditory stimulation conditions .


Neither baseline fall history nor performance of activities of daily living accounted for these differences .


Our results provide preliminary evidence of the differentiating effect of emotionally charged auditory stimuli on gait performance in older individuals with minimal cognitive impairment compared with those without minimal cognitive impairment .


A divided attention task using emotionally charged auditory stimuli might be able to elicit compensatory improvement in gait performance in cognitively intact older individuals , but lead to decompensation in those with minimal cognitive impairment .


Further investigation is needed to compare gait performance under this task to gait on other dual-task paradigms and to separately examine the effect of physiological aging versus cognitive impairment on gait during walking under auditory constraints .


To investigate the better method of digestive tract reconstruction in proximal gastrectomy for early gastroesophageal junction adenocarcinoma .


A total of 153 cases of early gastroesophageal junction adenocarcinoma who were planned to receive radical proximal gastrectomy from January 2003 to December 2011 were prospectively enrolled and randomly divided into two groups by table of random number according to methods of digestive tract reconstruction , including 3S anastomosis group ( 80 cases , 3S jejunal interposition ) and traditional anastomosis group ( 73 cases , esophageal remnant gastric posterior wall anastomosis ) .


Postoperative complications , operative time , mortality , nutritional parameters and postoperative quality of life were compared between these two groups .


There were no significant differences between two groups in postoperative complications , operative time and mortality ( all P > 0.05 ) .


3S anastomosis group was better in nutritional parameters than traditional group six months after operation ( P < 0.05 ) .


As compared to traditional group , incidence of reflux esophagitis decreased [ 20.0 % ( 16/80 ) vs. 46.6 % ( 34/73 ) , P < 0.01 ] and gastric emptying time prolonged obviously [ ( 160.88.1 ) min vs. ( 61.110.8 ) min , P < 0.01 ] in 3S anastomosis group 18 months after operation .


Postoperative QLQ-C30 rating scale revealed quality of life was significantly higher in 3S anastomosis group as compared to traditional group .


Jejunal interposition is a better method of digestive tract reconstruction in proximal gastrectomy for early gastroesophageal junction carcinoma .


A brief psychodynamic interpersonal therapy ( PIT ) in patients with multisomatoform disorder has been recently shown to improve health-related quality of life .


To assess cost-effectiveness of PIT compared to enhanced medical care in patients with multisomatoform disorder .


An economic evaluation alongside a randomised controlled trial ( International Standard Randomised Controlled Trial Number ISRCTN23215121 ) conducted in 6 German academic outpatient centres was performed .


Incremental cost-effectiveness ratio ( ICER ) was calculated from the statutory health insurance perspective on the basis of quality adjusted life years ( QALYs ) gained at 12 months .


Uncertainty surrounding the cost-effectiveness of PIT was presented by means of a cost-effectiveness acceptability curve .


Based on the complete-case analysis ICER was 41840 Euro per QALY .


The results did not change greatly with the use of multiple imputation ( ICER = 44222 ) and last observation carried forward ( LOCF ) approach to missing data ( ICER = 46663 ) .


The probability of PIT being cost-effective exceeded 50 % for thresholds of willingness to pay over 35 thousand Euros per QALY .


Cost-effectiveness of PIT is highly uncertain for thresholds of willingness to pay under 35 thousand Euros per QALY .


To analyze the effect of biological maturation on training-induced strength and endurance adaptations in the prepubertal growth spurt .


One hundred and twenty-five healthy children ( 58 boys , 67 girls ) , aged 10-11 years old ( 10.8 0.4 years ) , who were self-assessed as belonging to Tanner stages I and II , were randomly divided into two experimental groups , a strength training group ( 19 boys , 22 girls ) and an endurance training group ( 21 boys , 24 girls ) that would train twice a week for 8 weeks , as well as a control group ( 18 boys , 21 girls ; no training program ) .


After 8 weeks of training , there were improvements in all strength and endurance measures ( P < 0.01 ) for both groups of Tanner stage I and II children .


No significant differences in training response were observed relative to biological maturity or gender ( P > 0.05 ) .


These data suggest that more biologically mature prepubescent children seem to have no advantage in training-induced strength and endurance adaptations compared with their less mature peers .


Additionally , gender did not affect the training-induced changes in strength or aerobic fitness .


These results are meaningful for the development of optimized well-rounded training programs in prepubertal children .


Am .


J. Hum .


Biol .


26:469 -475 , 2014.2014 Wiley Periodicals , Inc. .


24,25-Dihydroxyvitamin D [ 24,25 ( OH ) 2D ] in serum may be both a nuisance and nutritionally valuable .


We investigated the impact of 24,25 ( OH ) 2D3 on the performance of commercially available immunoassays for serum total 25-hydroxyvitamin D [ 25 ( OH ) D ] using ( a ) serum from a nationally representative sample of adults , ( b ) serum from a spiking experiment , and ( c ) data from the UK Vitamin D External Quality Assurance Scheme ( DEQAS ) .


We also investigated the utility of the serum ratio of 24,25 ( OH ) 2D3 to 25 ( OH ) D as an index of inactivation and of response to vitamin D supplementation using randomized controlled trial ( RCT ) data .


Measurement of 24,25 ( OH ) 2D in sera by a LC-MS/MS method allowed for an investigation of its impact on immunoassay-derived serum 25 ( OH ) D values as well as its clinical utility .


We report data from a nationally representative sample of adults , a recent vitamin D RCT in older adults , and DEQAS .


24,25 ( OH ) 2D3 contributed to the positive bias observed in some immunoassays relative to LC-MS/MS-derived estimates for total 25 ( OH ) D.


A spiking experiment showed that the degree of cross-reactivity with 24,25 ( OH ) 2D was high and may underpin this positive bias .


Adjustment for 24,25 ( OH ) 2D3 concentration brought estimates closer to true values .


Data from the vitamin D RCT showed that the ratio of 24,25 ( OH ) 2D3 to 25 ( OH ) D was associated with serum 25 ( OH ) D3 and with response of serum 25 ( OH ) D to vitamin D supplementation .


Our findings highlight that the effect of 24,25 ( OH ) 2D3 in serum is a double-edged sword-an interferent for some immunoassays , yet potentially informative of nutritional status .


The progressive nature of heart failure ( HF ) coupled with high mortality and poor quality of life mandates greater attention to palliative care as a routine component of advanced HF management .


Limited evidence exists from randomized , controlled trials supporting the use of interdisciplinary palliative care in HF .


PAL-HF is a prospective , controlled , unblinded , single-center study of an interdisciplinary palliative care intervention in 200 patients with advanced HF estimated to have a high likelihood of mortality or rehospitalization in the ensuing 6 months .


The 6-month PAL-HF intervention focuses on physical and psychosocial symptom relief , attention to spiritual concerns , and advanced care planning .


The primary end point is health-related quality of life measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale score at 6 months .


Secondary end points include changes in anxiety/depression , spiritual well-being , caregiver satisfaction , cost and resource utilization , and a composite of death , HF hospitalization , and quality of life .


PAL-HF is a randomized , controlled clinical trial that will help evaluate the efficacy and cost effectiveness of palliative care in advanced HF using a patient-centered outcome as well as clinical and economic end points .


There is a need to find simple cost effective weight loss interventions that can be used in primary care .


There is evidence that self-monitoring is an effective intervention for problem drinking and self-weighing might be an effective intervention for weight loss .


To examine the efficacy of daily self-weighing as an intervention for weight loss .


A randomised controlled trial of 183 obese adults , follow-up three months .


The intervention group were given a set of weighing scales and instructed to weigh themselves daily and record their weight .


Both groups received two weight loss consultations which were known to be ineffective .


92 participants were randomised to the intervention group and 91 to the control group .


The intervention group lost 0.5 kg ( 95 % CI 0.3 to 1.3 kg ) more than the control group , but this was not significant .


There was no evidence that self-weighing frequency was associated with more weight loss .


As an intervention for weight loss , instruction to weigh daily is ineffective .


Unlike other studies , there was no evidence that greater frequency of self-weighing is associated with greater weight loss .


ISRCTN05815264 .


Cardiac surgery can be complicated by postoperative cognitive decline ( POCD ) , which is characterized by impaired memory function and intellectual ability .


The systemic inflammatory response that is induced by major surgery and cardiopulmonary bypass may play an important role in the etiology of POCD .


Prophylactic corticosteroids to attenuate the inflammatory response may therefore reduce the risk of POCD .


The authors investigated the effect of intraoperative high-dose dexamethasone on the incidence of POCD at 1 month and 12 months after cardiac surgery .


This multicenter , randomized , double-blind , placebo-controlled trial is a preplanned substudy of the DExamethasone for Cardiac Surgery trial .


A total of 291 adult patients undergoing cardiac surgery with cardiopulmonary bypass were recruited in three hospitals and randomized to receive dexamethasone 1 mg/kg ( n = 145 ) or placebo ( n = 146 ) .


The main outcome measures were incidence of POCD at 1 - and 12-month follow-up , defined as a decline in neuropsychological test performance beyond natural variability , as measured in a control group .


At 1-month follow-up , 19 of 140 patients in the dexamethasone group ( 13.6 % ) and 10 of 138 patients in the placebo group ( 7.2 % ) fulfilled the diagnostic criteria for POCD ( relative risk , 1.87 ; 95 % CI , 0.90 to 3.88 ; P = 0.09 ) .


At 12-month follow-up , 8 of 115 patients in the dexamethasone group ( 7.0 % ) and 4 of 114 patients ( 3.5 % ) in the placebo group had POCD ( relative risk , 1.98 ; 95 % CI , 0.61 to 6.40 ; P = 0.24 ) .


Intraoperative high-dose dexamethasone did not reduce the risk of POCD after cardiac surgery .


As glycaemia and the incidence of microvascular diabetes complications follow a log-linear relationship , it becomes increasingly difficult to demonstrate a microvascular benefit of glucose-lowering when the HbA1c level is close to normal .


The Outcome Reduction with an Initial Glargine Intervention ( ORIGIN ) trial randomised 12,537 people with diabetes , impaired glucose tolerance or impaired fasting glucose to receive standard glycaemic care or standard care with the addition of basal insulin glargine ( A21Gly , B31Arg , B32Arg human insulin ) , targeting a fasting plasma glucose level 5.3 mmol/l .


Microvascular outcomes during a median follow-up of 6.2 years were examined in participants whose baseline HbA1c was above or below the median of 6.4 % ( 46.4 mmol/mol ) .


Allocation to the insulin glargine group reduced the incidence of the primary microvascular composite outcome of kidney and eye disease in participants whose baseline HbA1c level was 6.4 % ( 46.4 mmol/mol ; HR 0.90 [ 95 % CI 0.81 , 0.99 ] ) but not in participants with a lower baseline HbA1c ( HR 1.07 [ 95 % CI 0.95 , 1.20 ] ; p value for interaction 0.031 ) .


In people whose baseline HbA1c level was 6.4 % ( 46.4 mmol/mol ) , the median post-randomisation change in HbA1c was -0.65 % ( interquartile range -0.16 , -0.91 % ) after allocation to insulin glargine and -0.33 % ( -0.83 , 0.13 % ) after allocation to standard care ( median HbA1c difference 0.33 % ; p < 0.0001 ) .


A smaller median difference of 0.22 % was noted in people whose baseline HbA1c was < 6.4 % ( p < 0.0001 ) .


In patients with dysglycaemia , intervention targeting normal fasting glucose levels reduced HbA1c and attenuated the risk of microvascular outcomes in participants with a baseline HbA1c level 6.4 % ( 46.4 mmol/mol ) .


A neutral effect was seen in those with a lower baseline HbA1c level .


ClinicalTrials.gov NCT00069784 .


Effective reduction of albuminuria and blood pressure in patients with type 2 diabetes who have nephropathy is seldom achieved with available treatments .


We tested the effects of treatment of such patients with daglutril , a combined endothelin-converting enzyme and neutral endopeptidase inhibitor .


We did this randomised , crossover trial in two hospitals in Italy .


Eligibility criteria were : age 18 years or older , urinary albumin excretion 20-999 g/min , systolic blood pressure ( BP ) less than 140 mm Hg , and diastolic BP less than 90 mm Hg .


Patients were randomly assigned ( 1:1 ) with a computer-generated randomised sequence to receive either daglutril ( 300 mg/day ) then placebo for 8 weeks each or vice versa , with a 4-week washout period .


Patients also took losartan throughout .


Participants and investigators were masked to treatment allocation .


The primary endpoint was 24-h urinary albumin excretion in the intention-to-treat population .


Secondary endpoints were median office and ambulatory ( 24 h , daytime , and night-time ) BP , renal haemodynamics and sieving function , and metabolic and laboratory test results .


This study is registered with ClinicalTrials.gov , number NCT00160225 .


We screened 58 patients , of whom 45 were enrolled ( 22 assigned to daglutril then placebo , 23 to placebo then daglutril ; enrolment from May , 2005 , to December , 2006 ) and 42 ( 20 vs 22 ) were included in the primary analysis .


Daglutril did not significantly affect 24-h urinary albumin excretion compared with placebo ( difference in change -76 g/min , IQR -787 to 190 ; p = 0559 ) .


34 patients had complete 24-h BP readings ; compared with placebo , daglutril significantly reduced 24-h systolic ( difference -52 mm Hg , SD 94 ; p = 00013 ) , diastolic ( -25 , 62 ; p = 0015 ) , pulse ( -30 , 63 ; p = 0019 ) , and mean ( -31 , 62 ; p = 0003 ) BP , as well as all night-time BP readings and daytime systolic , pulse , and mean BP , but not diastolic BP .


Compared with placebo , daglutril also significantly reduced office systolic BP ( -54 , 154 ; p = 0028 ) , but not diastolic ( -18 , 99 ; p = 0245 ) , pulse ( -31 , 106 ; p = 0210 ) , or mean ( -21 , 104 ; p = 0205 ) BP , and increased big endothelin serum concentration .


Other secondary outcomes did not differ significantly between treatment periods .


Three patients taking placebo and six patients taking daglutril had mild treatment-related adverse events -- the most common was facial or peripheral oedema ( in four patients taking daglutril ) .


Daglutril improved control of BP in hypertensive patients with type 2 diabetes and nephropathy and had an acceptable safety profile .


Combined endothelin-converting enzyme and neutral endopeptidase inhibition could provide a new approach to hypertension in this high-risk population .


Solvay Pharmaceuticals .


To compare the effects of body weight-supported treadmill training and overground walking training when matched for task and dose ( duration/frequency/intensity ) on improving walking function , activity , and participation after stroke .


Single-blind , pilot randomized controlled trial with three-month follow-up .


University and community settings .


A convenience sample of participants ( N = 20 ) at least six months post-stroke and able to walk independently were recruited .


Thirty-minute walking interventions ( body weight-supported treadmill training or overground walking training ) were administered five times a week for two weeks .


Intensity was monitored with the Borg Rating of Perceived Exertion Scale at five-minute increments to maintain a moderate training intensity .


Walking speed ( comfortable/fast 10-meter walk ) , walking endurance ( 6-minute walk ) , spatiotemporal symmetry , and the ICF Measure of Participation and ACTivity were assessed before , immediately after , and three months following the intervention .


The overground walking training group demonstrated significantly greater improvements in comfortable walking speed compared with the body weight-supported treadmill training group immediately ( change of 0.11 m/s vs. 0.06 m/s , respectively ; p = 0.047 ) and three months ( change of 0.14 m/s vs. 0.08 m/s , respectively ; p = 0.029 ) after training .


Only the overground walking training group significantly improved comfortable walking speed ( p = 0.001 ) , aspects of gait symmetry ( p = 0.032 ) , and activity ( p = 0.003 ) immediately after training .


Gains were maintained at the three-month follow-up ( p < 0.05 ) for all measures except activity .


Improvements in participation were not demonstrated .


Overgound walking training was more beneficial than body weight-supported treadmill training at improving self-selected walking speed for the participants in this study .


To assess the influence of simulated oral erosive/abrasive challenges on the bond strength of an etch-and-rinse two-step bonding system to enamel using an in situ/ex vivo protocol .


Bovine enamel blocks were prepared and randomly assigned to four groups : CONT - control ( no challenge ) , ABR - 3x/day -1 minute toothbrushing ; ERO - 3x/day - 5 minutes extraoral immersion into regular Coca Cola ; and ERO+ABR - erosive protocol followed by a 1-minute toothbrushing .


Eight blocks were placed into an acrylic palatal appliance for each volunteer ( n = 13 ) , who wore the appliance for 5 days .


Two blocks were subjected to each of the four challenges .


Subsequently , all the blocks were washed with tap water and Adper Single Bond 2/Filtek Z350 were placed .


After 24 hours , 1 mm2 beams were obtained from each block to be tested with the microtensile bond strength test ( 50 N load at 0.5 mm/minute ) .


The data were statistically analyzed by one-way RM-ANOVA and Tukey 's tests ( alpha = 0.05 ) .


No difference was detected among the ABR , ERO , and CONT groups ( P > 0.05 ) .


ERO+ABR group yielded lower bond strengths than either the ABR and ERO groups ( P < 0.0113 ) .


To investigate the effect of enhanced nutritional therapy on wound healing after endoscopic therapy in patients with liver cirrhosis and esophageal varices .


Fifty patients with liver cirrhosis and esophageal varices were randomly divided into an enhanced nutritional therapy group ( n = 25 ) and a control group ( n = 25 ) .


The enhanced nutritional therapy group received one week of enhanced nutritional supplementation , including liver nutritional elements , prior to routine endoscopic therapy .


The routine without any change to their diet .


The rate of transformation and status of wound healing of esophageal varices were compared between the two groups .


The ratio of ulcers occurring at the injection site was lower in the enhanced nutrition group than in the control group ( 16/25 vs. 23/25 ; x2 = 5.711 , P = 0.017 ) .


The enhanced nutrition group had only one case of minimal bleeding occurring during endoscopy as compared to the seven cases of bleeding in the control group ( x2 = 5.357 , P = 0.021 ) .


On average , the enhanced nutrition group required less sessions of endoscopic treatment to achieve eradication of esophageal varices than the control group ( 3.8 vs. 4.1 ; t = 2.069 , P = 0.044 ) .


Pre-endoscopic enhanced nutritional therapy may benefit patients with liver cirrhosis and esophageal varices by promoting recovery of procedure-related local tissue injury and occlusion of varices .


Most adolescents relapse within 90 days of discharge from residential substance use treatment .


We hypothesized that contingency management ( CM ) , assertive continuing care ( ACC ) , and their combination ( CM + ACC ) would each be more effective than usual continuing care ( UCC ) .


Following residential treatment , 337 adolescents were randomized to 4 continuing care conditions : UCC alone , CM , ACC , or CM + ACC .


UCC was available across all conditions .


Outcome measures over 12 months included percentage of days abstinent from alcohol , heavy alcohol , marijuana , and any alcohol or other drugs ( AOD ) using self-reports and toxicology testing and remission status at 12 months .


CM had significantly higher rates of abstinence than UCC for heavy alcohol use , t ( 297 ) = 2.50 , p < .01 , d = 0.34 ; any alcohol use , t ( 297 ) = 2.58 , p < .01 , d = 0.36 ; or any AOD use , t ( 297 ) = 2.12 , p = .01 , d = 0.41 ; and had a higher rate in remission , odds ratio ( OR ) = 2.45 , 90 % confidence interval ( CI ) [ 1.18 , 5.08 ] , p = .02 .


ACC had significantly higher rates of abstinence than UCC from heavy alcohol use , t ( 297 ) = 2.66 , p < .01 , d = 0.31 ; any alcohol use , t ( 297 ) = 2.63 , p < .01 , d = 0.30 ; any marijuana use , t ( 297 ) = 1.95 , p = .02 , d = 0.28 ; or any AOD use , t ( 297 ) = 1.88 , p = .02 , d = 0.30 ; and had higher rates in remission , OR = 2.31 , 90 % CI [ 1.10 , 4.85 ] , p = .03 .


The ACC + CM condition was not significantly different from UCC on any outcomes .


CM and ACC are promising continuing care approaches after residential treatment .


Future research should seek to further improve their effectiveness .


A randomized controlled trial ( RCT ) and an extension trial of qigong ( Chaoyi Fanhuan qigong [ CFQ ] ) in patients with fibromyalgia were recently completed .


In the present study , a qualitative analysis of comments from the RCT was undertaken using motivation and amount of practice to determine whether initial experiences provided information relevant to outcomes .


Participants in the RCT received instruction in qigong ( level 1 CFQ ) , practiced 45min/day for 8 weeks and continued practice to 6 months ; open-ended qualitative comments on experiences were invited at 8 weeks and 4 and 6 months .


Extension trial participants received further instruction ( level 2 CFQ ) and practiced regularly for 8 weeks-6 months .


Comments from the original RCT were considered as narratives for the extension trial subgroup ( n = 20 ) and thematically , according to amount of practice , for all participants who completed the RCT ( n = 73 ) .


Narrative comments from the RCT for those who completed the extension trial ( n = 13 ) and those who withdrew from that trial ( n = 7 ) were considered separately .


Participants reporting benefits within the first 8 weeks were more likely to maintain practice and report continued benefits at 4-6 months than those who withdrew from the trial .


Thematic comments for all who completed the RCT ( n = 73 ) were considered in relation to amount of practice ( per protocol , intermediate , minimal ) .


Participants who practiced per protocol during the initial 8 weeks ( 5 hours/wk ) were more likely to maintain practice over 4-6 months and to report beneficial health effects from qigong .


This retrospective qualitative analysis of information collected in an RCT of qigong for fibromyalgia indicates that favorable initial experiences with the practice over 8 weeks predispose to continued practice and more health effects .


Future individual trials and meta-analyses of qigong will need to attend to the amount , and potentially quality , of practice undertaken in considering trial outcomes .


The aim of the present study was to evaluate the efficacy and tolerability of vandetanib plus gemcitabine ( V/G ) compared with gemcitabine alone in elderly patients with untreated advanced non-small-cell lung cancer .


This was a phase II , randomized , double-blind study .


A total of 124 elderly patients ( mean age , 75 yr ; age range , 70-84 yr ; 73 % men ) received V/G ( n = 61 ) or placebo plus gemcitabine ( n = 63 ) .


Progression-free survival ( PFS ) was the primary endpoint .


Secondary endpoints were overall survival , objective response rate , duration of response , disease control rate , time to deterioration of performance status , and safety outcomes .


PFS was significantly prolonged with V/G ( median , 183 days ; 95 % confidence interval , 116-214 ) compared with placebo plus gemcitabine ( median , 169 days ; 95 % confidence interval , 95-194 ; p = 0.047 ) .


No statistically significant differences between arms were observed in all secondary endpoints , including overall survival .


The addition of vandetanib to gemcitabine was well tolerated .


The rate of patients with 1 treatment-related adverse event was comparable in the two arms , pyrexia , dyspnea , and neutropenia being the most common adverse events .


V/G combination was associated with a statistically significant prolongation of PFS compared with gemcitabine alone in untreated elderly patients with advanced non-small-cell lung cancer , with an acceptable safety profile .


Research has shown that obese individuals have cognitive deficiencies in executive function , leading to poor planning and impulse control , and decision-making difficulties .


An intervention that could help reduce these deficits and in turn help weight loss maintenance is Cognitive Remediation Therapy for Obesity ( CRT-O ) .


We aim to examine the efficacy of manualised CRT-O , which is intended to improve executive function , enhance reflective practice and help weight loss maintenance .


A randomised controlled trial ( registered with the Australian New Zealand Clinical Trials Registry ) will be conducted .


First , 90 obese adults ( body mass index > 30 kg/m2 ) in the community will receive three weekly sessions of a group Behaviour Weight Loss Treatment ( BWLT ) , and then will be randomised either to receive CRT-O or to enter a no-treatment control group .


CRT-O training will comprise twice-weekly sessions of 45 minutes over a 4 to 6 week period , for a total of eight sessions .


Measurement points will be at baseline , post CRT-O ( or 4 to 6 weeks after BWLT for the no-treatment control ) , 3 months post treatment and 1 year post treatment .


The primary outcome will be executive function and secondary outcome measures will include participants ' body mass index , hip to waist ratio , eating behaviours and quality of life .


This is the first study of its kind to examine the efficacy of Cognitive Remediation Therapy for obese adults through a randomised controlled trial .


Australian New Zealand Clinical Trials Registry number : 12613000537752 .


Date of registration : 14 May 2013 .


The systematic pro-inflammatory responses after percutaneous coronary intervention with drug-eluting stents ( DES ) remain poorly defined .


Therefore , we compared the systematic pro-inflammatory state of circulating mononuclear cells ( MNCs ) between DES and bare metal stent ( BMS ) implantation .


Patients with indications for treatment with stents were randomized in a 1:1 ratio to placement of DES or BMS .


The primary endpoint was a change of pro-inflammatory state at 12 weeks post-procedure .


Thirty-six consecutive patients received DES or BMS .


At 12 weeks after stent implantation , the lipid profile and high-sensitivity C-reactive protein ( hs-CRP ) improved significantly in both groups .


The mRNA levels and plasma concentrations of interleukin-6 , tumor necrosis factor - and matrix metalloproteinase-9 were significantly elevated in the DES group , which was not observed in the BMS group .


An increase in NF-B binding activity and a decrease in PPAR - expression in MNCs were observed in the DES group , along with increases in IB phosphorylation and p50 expression .


However , similar changes were not observed in the BMS group .


Systematic inflammatory responses were accentuated after the patients were treated percutaneously with DES , despite their improved lipid profile and hs-CRP .


These data may provide fundamental information for optimizing therapeutic strategy in the era of DES .