Men who undergo surgery for prostate cancer frequently experience significant side-effects including urinary and sexual dysfunction .


These difficulties can lead to anxiety , depression and reduced quality of life .


Many partners also experience psychological distress .


An additional impact can be on the couple relationship , with changes to intimacy , and unmet psychosexual supportive needs in relation to sexual recovery and rehabilitation .


The aim of this exploratory randomised controlled trial pilot study is to determine the feasibility and acceptability of a novel family-relational-psychosexual intervention to support intimacy and reduce distress among couples following prostate cancer surgery and to estimate the efficacy of this intervention .


The intervention will comprise six sessions of psychosexual and relationship support delivered by experienced couple-support practitioners .


Specialist training in delivering the intervention will be provided to practitioners and they will be guided by a detailed treatment manual based on systemic principles .


Sixty-eight couples will be randomised to receive either the intervention or standard care ( comprising usual follow-up hospital appointments ) .


A pre-test , post-test design will be used to test the feasibility of the intervention ( baseline , end of intervention and six-month follow-up ) and its acceptability to couples and healthcare professionals ( qualitative interviews ) .


Both individual and relational outcome measures will assess sexual functioning , anxiety and depression , couple relationship , use of health services and erectile dysfunction medication/technologies .


An economic analysis will estimate population costs of the intervention , compared to usual care , using simple modelling to evaluate the affordability of the intervention .


Given the increasing incidence and survival of post-operative men with prostate cancer , it is timely and appropriate to determine the feasibility of a definitive trial through a pilot randomised controlled trial of a family-relational-psychosexual intervention for couples .


The study will provide evidence about the components of a couple-based intervention , its acceptability to patients and healthcare professionals , and its influence on sexual and relational functioning .


Data from this study will be used to calculate sample sizes required for any definitive trial .


ClinicalTrials.gov Identifier : NCT01842438.Registration date : 24 April 2013 ; Randomisation of first patient : 13 May 2013 .


The possibility of living well with a long-term condition has been identified as centrally relevant to the needs of people living with dementia .


Growing numbers of people with early-stage dementia are contributing accounts that emphasise the benefits of actively engaging in managing the condition .


Self-management interventions share the common objectives of educating about the condition , optimising well-being , enhancing control over the situation and enabling people to take more responsibility for managing the condition .


Benefits of such an approach can include improved knowledge , self-efficacy , health status , and better performance of self-management behaviours .


However , there is only preliminary evidence that people with early-stage dementia can benefit from such interventions .


This feasibility study involves the development of a self-management group intervention for people with early-stage Alzheimer 's disease , vascular dementia or mixed Alzheimer 's and vascular dementia .


This study is a single-site pilot randomised-controlled trial .


Forty-two people with early stage dementia , each with a caregiver ( family member/friend ) , will be randomised to either the self-management group intervention or to treatment as usual.The self-management group intervention will involve eight weekly sessions , each lasting 90 minutes , held at a memory clinic in North Wales .


All participants will be re-assessed three and six months post-randomisation .


This study is intended to supply an early evaluation of the self-management intervention so that a full scale trial may be powered from the best available evidence .


It will assess the feasibility of the intervention , the study design and the recruitment strategies .


It will estimate the parameters and confidence intervals for the research questions of interest .


The primary outcome of interest is the self-efficacy score of the person with dementia at three months post-randomisation .


Secondary outcomes for the person with dementia are self-efficacy at six months post-randomisation and cognitive ability , mood and well-being at three and six months post-randomisation .


Secondary outcomes for caregivers are their distress and stress at three and six months post-randomisation .


The cost-effectiveness of the intervention will also be examined .


This study will provide preliminary information about the feasibility , efficacy and cost-effectiveness of a self-management group intervention for people in the early stages of dementia .


Current Controlled Trials , ISRCTN02023181 .


Inflammation may contribute to the high cardiovascular risk in diabetes mellitus ( DM ) and chronic kidney disease ( CKD ) .


Monocyte chemoattractant protein-1 ( MCP-1 ) facilitates the recruitment of monocytes into atherosclerotic lesions and is involved in diabetic nephropathy .


Interferon gamma ( IFN ) is important in atherosclerosis and increases the synthesis of chemokines including MCP-1 .


Lipid-lowering treatment ( LLT ) with statins may have anti-inflammatory effects , and ezetimibe cotreatment provides additional cholesterol lowering .


After a placebo run-in period , the effects of simvastatin alone ( S ) or simvastatin + ezetimibe ( S+E ) were compared in a randomized , double-blind , cross-over study on inflammatory parameters .


Eighteen DM patients with estimated glomerular filtration rate ( eGFR ) 15-59mL / min173m ( 2 ) ( CKD stages 3-4 ) ( DM-CKD ) and 21 DM patients with eGFR > 75mL/min ( DM only ) were included .


At baseline , monocyte chemoattractant protein 1 ( MCP-1 ) ( P = 003 ) , IFN ( P = 002 ) , tumour necrosis factor - ( TNF ) ( P < 001 ) and soluble vascular adhesion molecule ( sVCAM ) ( P = 0001 ) levels were elevated in DM-CKD compared with DM-only patients .


LLT with S and S+E reduced MCP-1 levels ( P < 001 by anova ) and IFN levels ( P < 001 ) in DM-CKD patients but not in DM-only patients .


Reductions were most pronounced with the combination treatment .


DM patients with CKD stages 3-4 had increased inflammatory activity compared with DM patients with normal GFR .


Lipid-lowering treatment decreased the levels of MCP-1 and IFN in DM patients with concomitant CKD , which may be beneficial with regard to the progression of both atherosclerosis and diabetic nephropathy .


Social connections at all stages of life are essential for physical and mental well-being .


Of particular importance are social relationships during adolescence that shape adult health behaviors and health outcomes .


The aim of this study was to estimate the association between adolescent peer status in school and later-life quality-adjusted life-years ( QALYs ) and healthcare costs .


This study used social network and health outcomes data from Wave I ( ages 12-18years ) and Wave III ( ages 18-24years ) of the US National Longitudinal Study of Adolescent Health ( n = 10,578 ) to compare QALYs and healthcare costs ( in 2012 US$ ) by adolescent peer status in US schools .


Generalized linear models controlled for school fixed effects , individual and family characteristics , and US census block neighborhood effects .


Non-parametric bootstrapping accounted for residual skewness in QALYs and healthcare costs .


Net monetary benefit ( NMB ) was calculated by converting adjusted 5-year QALYs into US$ values and subtracting 5-year healthcare costs .


NMB was then compared across quintiles of adolescent peer status in school at Wave I.


Results obtained from non-parametric bootstrapping indicate that adolescents with higher peer status in school experience significantly better health and lower healthcare costs over the next 5years .


At US$ 50,000 per QALY , adolescents with 8 or more friends achieved NMB of US$ 214,300 ( 95 % CI 212,800-215 ,800 ) over a 5-year span , in comparison to adolescents with 0-1 friends , who attained US$ 209,900 ( 95 % CI 207,900-211 ,700 ) NMB .


This difference translates into approximately US$ 4,440 ( 95 % CI 2,036-6 ,825 ) per socially disengaged adolescent in additional health costs and/or reduced QALYs over 5years .


The study calls for randomized controlled trials targeting adolescent peer group structures in schools as a means to promote better health and lower healthcare costs in adulthood .


Prediction of long-term outcomes in patients with community-acquired pneumonia ( CAP ) is incompletely understood .


We investigated the value of clinical risk scores [ pneumonia severity index ( PSI ) and CURB-65 ] ( Confusion , Urea , Respiratory rate , Blood Pressure , Age > 65years ) and blood biomarkers of different physiopathological pathways in predicting long-term survival in a well-characterized cohort of patients with CAP enrolled in an antibiotic stewardship trial .


Patients admitted with CAP to six medical centres in Switzerland were prospectively followed for 6years .


Cox regression models and area under the receiver operating characteristics curve ( AUC ) were used to investigate associations between initial risk assessment and all-cause mortality .


All-cause mortality during a 6-year follow-up period .


Six-year mortality in the present cohort ( median age 73years ) was 45.1 % [ 95 % confidence interval ( CI ) 41.8-48 .3 % ] .


Initial PSI and CURB-65 scores both had excellent long-term prognostic accuracy , with a stepwise increase in mortality per risk class .


The hazard ratios ( 95 % CI ) of the highest PSI and CURB-65 classes ( reference : lowest class ) were 38.0 ( 14.0-103 .0 ) and 7.8 ( 2.2-14 .5 ) , respectively , after 6years .


The addition of inflammatory ( pro-adrenomedullin ) and cardiac ( pro-atrial natriuretic peptide ) blood biomarkers measured upon hospital admission further improved the prognostic capabilities of the PSI ( AUC increase from 0.79 to 0.83 ; P < 0.0001 ) and the CURB-65 score ( AUC increase from 0.73 to 0.80 ; P < 0.001 ) .


Risk assessment using clinical scores allowed accurate long-term prognostication , which was further improved by the addition of two inflammatory ( pro-adrenomedullin ) and cardiac ( pro-atrial natriuretic peptide ) blood biomarkers .


These data provide a rationale for a more risk-adapted , ` personalized ' strategy for long-term management of patients with CAP .


Because of limited impact on infant morbidity , mortality , and vitamin A status , the new guideline of the World Health Organization ( WHO ) does not recommend postpartum vitamin A supplementation ( VAS ) as a public health intervention in developing countries .


However , breast milk contains numerous immune-protective components that are important for infant immune development , and several of these components are regulated by vitamin A.


Postpartum women are being enrolled within 3days ( d ) of delivery at a maternity clinic located in a slum area of Dhaka city and randomized to one of four postpartum VAS regimens ( 32/group , total 128 ) .


The regimens are as follows : Group 1 : 200,000 IU VAS at < 3 d and placebo at 6weeks postpartum ; Group 2 : placebo at < 3 d and 200,000 IU VAS at 6weeks postpartum ; Group 3 : 200,000 IU VAS , both at < 3 d and 6weeks postpartum ; Group 4 : placebo , both at < 3 d and 6weeks postpartum .


Breast milk samples at < 3 d ( before supplementation ) and 4months postpartum will be used to measure vitamin A and bioactive compounds .


Infant blood samples at 2 and 4months of age will be used to measure vitamin A , as well as innate and vaccine-specific immune responses .


Dietary , anthropometric , and morbidity data are also being collected .


This is the first placebo-controlled randomized clinical trial of postnatal vitamin A supplementation to investigate the key bioactive compounds in breast milk , important for infant immunity , in relation to dose and time point of postpartum supplementation and whether such maternal supplementation improves infant immune status during the critical period of early infancy .


ClinicalTrials.gov : NCT02043223 , 5 December 2013 .


To compare the therapeutic effects and adverse reactions of pemetrexed and docetaxel as salvage chemotherapy in patients with nonsmall-cell lung cancer ( NSCLC ) after the failure of epidermal growth factor receptor-tyrosine kinase inhibitors ( EGFR-TKI ) .


In this randomized Phase 2 trial , patients with NSCLC who had previously failed EGFR-TKI therapy were randomized to receive intravenous pemetrexed ( 500mg/m ( 2 ) for 21 days [ one cycle ] ) or docetaxel ( 75mg/m ( 2 ) for 21 days [ one cycle ] ) .


Therapeutic effects were evaluated according to Response Evaluation Criteria in Solid Tumours standards and adverse effects were evaluated according to the US National Cancer Institute Common Terminology Criteria for Adverse Events .


There was no statistically significant difference in disease control rate , response rate , median survival and 1-year survival between treatment groups .


Rates of nausea , myelosuppression , renal damage and hair loss were significantly higher in the docetaxel group than the pemetrexed group .


Pemetrexed is effective and well tolerated as salvage chemotherapy in patients with NSCLC after EGFR-TKI failure and may be a suitable therapeutic option in these patients .


Long-term physical activity is reported to improve chronic systemic inflammation , which provides protection against the ensuing development of chronic disease .


Accordingly , the present study assessed changes in pro- and anti-inflammatory cytokines , aerobic capacity and body composition following 8 weeks of either small-sided games ( SSG ) or cycling ( CYC ) training compared to a sedentary control ( CON ) condition .


Thirty-three middle-aged , sedentary men were randomized into CYC ( n = 11 ) , SSG ( n = 11 ) , or CON ( n = 11 ) conditions .


The CYC and SSG conditions trained 3 days/week for 8 weeks , whilst CON maintained habitual activity and dietary patterns .


Pre - and post-intervention testing included a dual-energy X-ray absorptiometry scan , sub-maximal ( 80 % maximal heart rate ) aerobic capacity ( VO ) and fasting venous blood .


Venous blood measures for pro-inflammatory markers included C-reactive protein ( CRP ) , interleukin ( IL ) -6 , IL-1 , tumor necrosis factor - , and leptin ; anti-inflammatory markers included IL-10 , IL-1 receptor agonist , and adiponectin .


Both CYC and SSG increased submaximal power output and VO ( P < 0.05 ) , decreased total body fat-mass ( TB-FM ; P < 0.05 ) , and CRP ( SSG , -0.45 0.42 mg L ( -1 ) ; P = 0.008 ; CYC , -0.44 0.59 mg L ( -1 ) ; P = 0.02 ) .


Only SSG increased total body fat-free mass ( TB-FFM ; +1.1 1.2 kg ; P = 0.001 ) and decreased concentration of plasma IL-6 ( -0.69 0.62 pg mL ( -1 ) ; P = 0.002 ) and leptin ( -2,212 2,531 ng mL ( -1 ) ; P = 0.014 ) .


Cycling and SSG training were both effective at improving CRP , VO and TB-FM .


Furthermore , SSG training has also shown to be an effective training approach in reducing IL-6 and leptin and increasing muscle mass within sedentary , middle-aged men .


To determine whether a cyromazine-resistant strain of Lucilia cuprina was able to establish strikes sooner than a susceptible strain on cyromazine - or dicyclanil-treated sheep .


Groups of 7 sheep were treated with cyromazine or dicyclanil in accordance with label directions .


Beginning 5 weeks after treatment , 5 sheep from each group were challenged by implantation of neonate larvae belonging to the cyromazine-resistant strain ` Nimmitabel-selected ' and the susceptible blowfly strain ` Field 2011 ' according to standard larval implant technique .


The implant sites were alternated between the shoulder , mid-back and rump within the treatment zone .


Similarly , implants of the resistant and susceptible strain larvae were alternated at each challenge such that the strain implanted on the left side of the sheep at one challenge was implanted on the right side at the next .


Challenges were conducted at 3-weekly intervals until the susceptible larvae formed strikes on at least 2 of the 5 sheep in a treatment group or until 29 weeks after treatment .


Sheep treated with cyromazine or dicyclanil were protected from flystrike by the cyromazine-susceptible strain for periods consistent with , or longer than , the registered product label claims .


The cyromazine-resistant strain created strikes several weeks sooner after treatment than did the susceptible strain .


Accordingly , the protection periods provided by cyromazine and dicyclanil against the resistant strain were reduced from 14 and 18-24 weeks to < 8 weeks and < 11 weeks , respectively .


Resistance , even in the pure-breeding resistant strain , was not so severe as to cause treatment failure with cyromazine or dicyclanil , but was sufficient to reduce the protection period provided .


It is recommended that producers adopt management practices that minimise the development of resistance to these and other compounds .


Cardiopulmonary bypass ( CPB ) , utilized in on-pump coronary artery bypass graft procedures ( CABG ) induces generalized immune suppression , release of heat shock proteins ( HSP ) , inflammatory markers and apoptosis-specific proteins .


We hypothesized that continued mechanical ventilation during cardiopulmonary bypass attenuates immune response and HSP liberation .


Thirty patients undergoing conventional coronary artery bypass graft ( CABG ) operation were randomized into a ventilated on CPB ( VG ; N. = 15 ) and a non-ventilated CPB group ( NVG ; N. = 15 ) .


Blood samples were drawn at the beginning and end of surgery , as well as on the five consecutive postoperative days ( POD ) .


Molecular markers were measured by ELISA .


Data are given as mean ( SD ) .


Mann-Whitney-U-test was used for statistical analysis .


Serum concentrations of HSP70 were significantly lower in VG compared to NVG on POD-1 ( VG : 1629608 vs. NVG : 52032128.6 pg/mL , P < 0.001 ) .


HSP27 and HSP60 depicted a minor increase in both study groups at the end of surgery without any intergroup differences ( HSP27 : VG 6207.91252.5 vs. NVG 7424.12632.5 ; HSP60 : VG 1046.2478.8 vs. NVG 1223.5510.1 ) .


IL-8 and CK-18 M30 evidenced the highest serum concentrations at the end of surgery ( IL-8 : VG 119.577.9 vs. NVG 148.0184.55 ; CK-18 M30 : VG 62.139.2 vs. NVG 67.533.9 ) with no differences between groups .


Decreased ICAM-1 serum concentrations were detected postoperatively , however ICAM-1 concentrations on POD-1 to POD-5 showed slightly elevated concentrations in both study groups with no intergroup differences .


Significantly less HSP70 was detectable in patients receiving uninterrupted mechanical lung ventilation on CPB , indicating either different inflammatory response , cellular stress or cell damage between the ventilated and non-ventilated group .


These data suggest that continued mechanical ventilation has a modulatory effect on the immune response in patients after CABG surgery .


Time in therapeutic range ( TTR ) is a standard quality measure of the use of warfarin .


We assessed the relative effects of rivaroxaban versus warfarin at the level of trial center TTR ( cTTR ) since such analysis preserves randomized comparisons .


TTR was calculated using the Rosendaal method , without exclusion of international normalized ratio ( INR ) values performed during warfarin initiation .


Measurements during warfarin interruptions > 7 days were excluded .


INRs were performed via standardized finger-stick point-of-care devices at least every 4 weeks .


The primary efficacy endpoint ( stroke or non-central nervous system embolism ) was examined by quartiles of cTTR and by cTTR as a continuous function .


Centers with the highest cTTRs by quartile had lower-risk patients as reflected by lower CHADS2 scores ( P < 0.0001 ) and a lower prevalence of prior stroke or transient ischemic attack ( P < 0.0001 ) .


Sites with higher cTTR were predominantly from North America and Western Europe .


The treatment effect of rivaroxaban versus warfarin on the primary endpoint was consistent across a wide range of cTTRs ( P value for interaction = 0.71 ) .


The hazard of major and non-major clinically relevant bleeding increased with cTTR ( P for interaction = 0.001 ) , however , the estimated reduction by rivaroxaban compared with warfarin in the hazard of intracranial hemorrhage was preserved across a wide range of threshold cTTR values .


The treatment effect of rivaroxaban compared with warfarin for the prevention of stroke and systemic embolism is consistent regardless of cTTR .


The prognostic utility of vascular endothelial growth factor A ( VEGF-A ) splice variants in patients with advanced breast cancer treated with bevacizumab has not been studied .


A total of 111 patients with metastatic breast cancer treated with weekly docetaxel or ixabepilone without bevacizumab ( cohort A ) and 100 treated with weekly paclitaxel and bevacizumab ( cohort B ) were studied .


Formalin-fixed tumors were macrodissected for reverse transcription quantitative polymerase chain reaction relative quantification of VEGF-A165 , -189 , and -206 isoforms spliced at exon 8 proximal splice site ( VEGF-Axxxa ) and at exon 8 distal splice site ( VEGF-Axxxb ) .


For high VEGF-Axxxa , the hazard ratios ( HRs ) for progression were 1.08 ( P = .71 ) in non-bevacizumab-treated patients ( cohort A ) and 0.66 ( P = .22 ) in bevacizumab-treated patients ( cohort B ) , and the HRs for death were 1.45 ( P = .13 ) and 0.50 ( P = .049 ) , respectively .


The interaction of VEGF-Axxxa with bevacizumab administration was significant ( P = .011 ) for overall survival ( OS ) .


High tissue VEGF-Axxxb was not prognostic in cohort A but was predictive for bevacizumab benefit in cohort B ( HR for progression , 0.57 [ P = .04 ] ; HR for death , 0.51 [ P = .02 ] ) .


Exploratory analyses done only in cohort B suggested that abundance of VEGFR1 messenger RNA ( mRNA ) in peripheral blood and low VEGFR2 mRNA in tissue correlated with poor outcome .


In multivariate analysis , high tissue mRNA of angiogenic VEGF-Axxxa in the presence of bevacizumab therapy predicted for favorable progression-free survival ( HR for progression , 0.39 ; P = .0227 ) and OS ( HR for death , 0.32 ; P = .0140 ) .


Tissue mRNA expression of angiogenic VEGF-Axxxa isoforms was retrospectively associated with adverse prognosis in the absence of bevacizumab and with favorable outcome when bevacizumab was administered in patients with advanced breast cancer .


Although anxiety is common in children with attention-deficit/hyperactivity disorder ( ADHD ) , it is unclear how anxiety influences the lives of these children .


This study examined the association between anxiety comorbidities and functioning by comparing children with ADHD and no , 1 , or 2 anxiety comorbidities .


Differential associations were examined by current ADHD presentation ( subtype ) .


Children with diagnostically confirmed ADHD ( N = 392 ; 5-13 years ) were recruited via 21 pediatrician practices across Victoria , Australia .


Anxiety was assessed by using the Anxiety Disorders Interview Schedule for Children-IV .


Functional measures included parent-reported : quality of life ( QoL ; Pediatric Quality of Life Inventory 4.0 ) , behavior and peer problems ( Strengths and Difficulties Questionnaire ) , daily functioning ( Daily Parent Rating of Evening and Morning Behavior ) , and school attendance .


Teacher-reported behavior and peer problems ( Strengths and Difficulties Questionnaire ) were also examined .


Linear and logistic regression controlled for ADHD severity , medication use , comorbidities , and demographic factors .


Children with 2 anxiety comorbidities ( n = 143 ; 39 % ) had poorer QoL ( effect size : -0.8 ) and more difficulties with behavior ( effect size : 0.4 ) and daily functioning ( effect size : 0.3 ) than children without anxiety ( n = 132 ; 36 % ) .


Poorer functioning was not observed for children with 1 anxiety comorbidity ( n = 95 ; 26 % ) .


Two or more anxiety comorbidities were associated with poorer functioning for children with both ADHD-Inattentive and ADHD-Combined presentation .


Children with ADHD demonstrate poorer QoL , daily functioning and behavior when 2 anxiety comorbidities are present .


Future research should examine whether treating anxiety in children with ADHD improves functional outcomes .


The role of human equilibrative nucleoside transporter 1 ( hENT1 ) as a predictive biomarker for gemcitabine efficacy in advanced pancreatic cancer remains unclear to date .


AIO-PK0104 was a German multicenter phase III trial comparing gemcitabine/erlotinib followed by capecitabine ( GEC ) with capecitabine/erlotinib followed by gemcitabine ( CEG ) in advanced pancreatic cancer .


Archival tumour tissue from 169 of the 274 eligible study patients was available for a central and standardised immunohistochemistry staining for hENT1 expression using the SP120 rabbit monoclonal anti-hENT1 antibody .


Within a retrospective translational subgroup analysis , biomarker data were correlated with efficacy end-points .


Thirty-nine out of 130 fresh-cut slides were scored as hENT1 ( high ) ( 30 % ) , whereas 91 samples were classified as hENT1 ( low ) ( 70 % ) .


For the 62 patients randomised to CEG median overall survival was estimated with 6.4 months in the hENT1 ( low ) compared to 6.9 months in the hENT1 ( high ) subgroup ( Hazard Ratio ( HR ) 0.88 , 95 % confidence interval ( CI ) 0.48-1 .61 , p = 0.67 ) .


For the 68 patients randomised to GEC survival was 5.7 months in the hENT1 ( low ) compared to 4.4 months in the hENT1 ( high ) subgroup ( HR 1.16 , 95 % CI 0.69-1 .96 , p = 0.57 ) .


In 101 patients receiving gemcitabine at any time during study treatment ( either within the 1st - or 2nd-line setting ) hENT1 ( low ) cases had a median overall survival of 7.5 months and hENT1 ( high ) patients an overall survival of 4.4 months ( HR 1.30 , 95 % CI 0.84-2 .03 , p = 0.24 ) , respectively .


Within this subgroup analysis from Arbeitsgemeinschaft Internistische Onkologie-pancreatic cancer ( AIO-PK0104 ) , no evidence supporting the use of hENT1 as a predictive biomarker for gemcitabine efficacy in patients with advanced pancreatic cancer was found .


This study aimed to compare the efficacy and safety of bismuth-included standard regimen and modified sequential treatments in Turkey , where the success rate of standard triple therapy is very low .


One-hundred and sixty patients with dyspeptic complaints and nave Helicobacter pylori infection were randomized into four groups : 41 patients received standard 14-day quadruple treatment ( STD ) ( Rabeprazole 20mg-bid , bismuth subcitrate ( 120 mg-qid ) , Tetracycline 500 mg-qid , Metronidazole 500 mg-tid ) for 2 weeks .


The modified sequential therapy groups received 20 mg rabeprazole and 1g amoxicillin , twice daily for the first 5 days , followed by Rabeprazole 20mg-bid , bismuth subcitrate ( 120 mg-qid ) , Tetracycline 500 mg-qid , Metronidazole 500 mg-tid for the remaining 5 ( 10 day sequential therapy group-10S ) ( 42 patients ) , 7 ( 12 day sequential therapy group-12S ) ( 42 patients ) and 9 ( 14 day sequential therapy group-14S ) ( 41 patients ) days .


The overall compliance and H. pylori eradication rate among the 160 patients who completed the H. pylori eradication regimens were 86.9 % ( 139/160 ) and 78.1 % ( 125/160 ) , respectively .


The results were not statistically different between groups in the eradication rates .


Per-protocol eradication rates were 76.5 % in STD , 71.4 % in 10S , 82.4 % in 12S and 83.3 % in 14S groups ( p = 0.7 ) .


Intention-to-treatment rates were 77.5 % in STD , 72.5 % in 10S , 82.5 % in 12S and 80.0 % in 14S groups ( p = 0.5 ) .


The eradication rates of standard 14-day and different sequential quadruple treatment regimens are comparable and much more higher than with standard 14-day triple H. pylori eradication treatment that has been reported previously in Turkey .


Restrictive , very low-energy diets focused on rapid weight loss have proven to be effective in improving asthma outcome in obese patients , but their use in children and pubescents is controversial due its potential consequences in growth .


More conservative , normocaloric schemes are suggested as a more suitable dietary approach for these patients .


A randomized clinical trial was run of 51 pubertal adolescents with asthma and obesity , who were allocated to either an interventional 28-week program of normocaloric diet based on normal requirements for height and meal planning ( n = 26 ) or a non-interventional ( free diet ) control group ( n = 25 ) .


Asthma-related quality of life ( AR-QOL , assessed by the Standardized Pediatric Asthma Quality of Life Questionnaire , PAQLQ [ S ] ) and clinical indicators of asthma control were measured before and after the intervention period .


Diet intervention was associated with a significant improvement in AR-QOL in relation to baseline ( PAQLQ [ S ] scores ) compared with controls , both in overall score ( p < 0.001 ) and its subdomains ( activity limitation , p < 0.001 ; symptoms , p < 0.002 ; emotional function , p < 0.001 ) .


The group with normocaloric diet observed a significant decrease in body mass index z-score , which correlated positively with the improvement in AR-QOL ( Spearman 's r = 0.51 , p < 0.01 ) , in addition to have significantly fewer events of acute attacks of asthma and nighttime awakenings , plus a non-significant reduction in the use of inhaled corticosteroids .


No significant changes were observed in the pulmonary function tests .


The normocaloric dietary intervention was associated with improvement of AR-QOL and some aspects of asthma control .


Such structured dietary programs could probably have a role as a complementary non-pharmacological therapeutic strategy in obese pubertal adolescents with asthma .


Because of symptoms , people with lumbar spinal stenosis ( LSS ) are often inactive , and this sedentary behaviour implies risk for diseases including obesity .


Research has identified body mass index as the most powerful predictor of function in LSS .


This suggests that function may be improved by targeting weight as a modifiable factor .


An e-health lifestyle intervention was developed aimed at reducing fat mass and increasing physical activity in people with LSS .


The main components of this intervention include pedometer-based physical activity promotion and nutrition education .


The Spinal Stenosis Pedometer and Nutrition Lifestyle INTERVENTION ( SSPANLI ) was developed and piloted with 10 individuals .


The protocol for a randomized controlled trail comparing the SSPANLI intervention to usual non-surgical care follows .


One hundred six ( 106 ) overweight or obese individuals with LSS will be recruited .


Baseline and follow-up testing includes dual energy x-ray absorptiometry , blood draw , 3-day food record , 7-day accelerometry , questionnaire , maximal oxygen consumption , neurological exam , balance testing and a Self-Paced Walking Test .


During Week 1 , the intervention group will receive a pedometer , and a personalized consultation with both a Dietitian and an exercise specialist .


For 12 weeks participants will log on to the e-health website to access personal step goals , walking maps , nutrition videos , and motivational quotes .


Participants will also have access to in-person Coffee Talk meetings every 3 weeks , and meet with the Dietitian and exercise specialist at week 6 .


The control group will proceed with usual care for the 12-week period .


Follow-up testing will occur at Weeks 13 and 24 .


This lifestyle intervention has the potential to provide a unique , non-surgical management option for people with LSS .


Through decreased fat mass and increased function , we may reduce risk for obesity , chronic diseases of inactivity , and pain .


The use of e-health interventions provides an opportunity for patients to become more involved in managing their own health .


Behaviour changes including increased physical activity , and improved dietary habits promote overall health and quality of life , and may decrease future health care needs in this population .


Clinicaltrials.gov , NCT01902979 .


In this study we hypothesized that signs of atypical atrial activation would be associated with cardiac resynchronization therapy ( CRT ) response in patients with mildly symptomatic heart failure ( CHF ) , left ventricular dysfunction , and wide QRS complex .


Patients included in the CRT-D arm in MADIT-CRT were studied ( n = 892 ) .


Unfiltered signal-averaged P waves were analyzed to determine orthogonal P-wave morphology ( typical morphologies were predefined as having positive signals in Leads X and Y and a negative or negative-positive signal in Lead Z. All other patterns were classified as atypical ) .


The association between P-wave morphology and data on echocardiographic response at 1 year was analyzed .


Atypical P-wave morphology was found in 21 % ( n = 186 ) of the patients at baseline .


Patients with atypical P-wave morphology were more often female ( 31 % vs. 24 % , P = 0.025 ) , had lower BMI ( 28 5 kg/m ( 2 ) vs. 29 5 kg/m ( 2 ) , P = 0.008 ) , had more ischemic CHF ( 60 % vs. 52 % , P = 0.026 ) and had smaller left atrial volumes ( 90 20 mL vs. 94 22 mL , P = 0.034 ) .


Atypical P-wave morphology at baseline was associated with superior response to CRT at 1 year with a larger reduction in left ventricular end-diastolic volume ( -23 12 % vs. -20 11 % , P = 0.009 ) , left ventricular end-systolic volume ( -36 16 % vs. -31 16 % , P = 0.006 ) , and left atrial volume ( -31 12 % vs. -27 12 % , P = 0.005 ) , with a slightly larger absolute increase in left ventricular ejection fraction ( LVEF ) ( 12 5 % vs. 11 5 % , P = 0.009 ) .


These associations were found to be independent of traditional predictors .


The presence of atypical P-wave morphology recorded is independently associated with a favorable echocardiographic cardiac remodeling response to CRT .


Classical laparoscopic cholecystectomy involves four ports while most novel ` single port ' technique only requires one incision on the abdominal wall .


This technique is thought to decrease surgical trauma and improve cosmesis although there are reports pointing out that classical laparoscopic cholecystectomy is also feasible in terms of cosmesis .


In this study we tried to determine if there are certain advantages in quality of life after single port surgery which would justify its utilization instead of classical laparoscopic cholecystectomy .


This is aprospective randomized study which enrolled 30 patients randomized either into classical laparoscopic cholecystectomy or single port surgery .


The primary endpoint was patient satisfaction after surgery .


This was assessed with short form 36 and gastrointestinal quality of life index ( first preoperatively and then 3months postoperatively ) and avisual analogue scale on the first and seventh days .


There was not astatistically significant difference between groups in the emotional role , social functions , mental health , vitality and general health subscales of short form 36 .


At the end of 12 weeks , both groups demonstrated increases in the gastrointestinal and social subscales of the gastrointestinal quality of life index .


There was not astatistically significant difference between groups when the visual analogue scale scores on first and seventh days were compared .


The equal length of hospitalization , patient quality of life and pain perception and the longer operative times , high likelihood of incisional hernia and surgical site infection call into question the utilization of single port surgery , as it does not seem to confer an advantage over classical laparoscopic cholecystectomy .


Iron deficiency anemia and serum phosphate levels > 4.0 mg/dL are relatively common in chronic kidney disease stages 3 to 5 and are associated with higher risks of progressive loss of kidney function , cardiovascular events , and mortality .


Double-blind , placebo-controlled , randomized trial .


149 patients with estimated glomerular filtration rates < 60 mL/min/1 .73 m ( 2 ) , iron deficiency anemia ( hemoglobin , 9.0-12 .0 g/dL ; transferrin saturation [ TSAT ] 30 % , serum ferritin 300 ng/mL ) , and serum phosphate levels 4.0 to 6.0 mg/dL .


Use of intravenous iron or erythropoiesis-stimulating agents was prohibited .


Randomization to treatment for 12 weeks with ferric citrate coordination complex ( ferric citrate ) or placebo .


Coprimary end points were change in TSAT and serum phosphate level from baseline to end of study .


Secondary outcomes included change from baseline to end of treatment in values for ferritin , hemoglobin , intact fibroblast growth factor 23 ( FGF-23 ) , urinary phosphate excretion , and estimated glomerular filtration rate .


Ferric citrate treatment increased mean TSAT from 22 % 7 % ( SD ) to 32 % 14 % and reduced serum phosphate levels from 4.5 0.6 to 3.9 0.6 mg/dL , while placebo exerted no effect on TSAT ( 21 % 8 % to 20 % 8 % ) and less effect on serum phosphate level ( 4.7 0.6 to 4.4 0.8 mg/dL ; between-group P < 0.001 for each ) .


Ferric citrate increased hemoglobin levels ( from 10.5 0.8 to 11.0 1.0 g/dL ; P < 0.001 vs placebo ) , reduced urinary phosphate excretion 39 % ( P < 0.001 vs placebo ) , and reduced serum intact FGF-23 levels from a median of 159 ( IQR , 102-289 ) to 105 ( IQR , 65-187 ) pg/mL ( P = 0.02 vs placebo ) .


The incidence and severity of adverse effects were similar between treatment arms .


The study is limited by relatively small sample size and short duration and by having biochemical rather than clinical outcomes .


Short-term use of ferric citrate repletes iron stores , increases hemoglobin levels , and reduces levels of serum phosphate , urinary phosphate excretion , and FGF-23 in patients with chronic kidney disease stages 3 to 5 .


The aim of this analysis was to assess the 7-year long-term safety and effectiveness of a randomized comparison of percutaneous coronary intervention ( PCI ) with sirolimus-eluting stents ( SES ) versus minimally invasive direct coronary artery bypass ( MIDCAB ) surgery for the treatment of isolated proximal left anterior descending lesions .


Long-term follow-up data comparing PCI by SES and MIDCAB surgery for isolated proximal left anterior descending lesions are sparse .


Patients were randomized either to PCI with SES ( n = 65 ) or MIDCAB ( n = 65 ) .


Follow-up data were obtained after 7 years with respect to the primary composite endpoint of death , myocardial infarction , and target vessel revascularization .


Angina was assessed by the Canadian Cardiovascular Society classification and quality of life with Short Form 36 and MacNew quality of life questionnaires .


Follow-up was conducted in 129 patients at a median time of 7.3 years ( interquartile range : 5.7 , 8.3 ) .


There were no significant differences in the incidence of the primary composite endpoint between groups ( 22 % PCI vs. 12 % MIDCAB ; p = 0.17 ) or the endpoints death ( 14 % vs. 17 % ; p = 0.81 ) and myocardial infarction ( 6 % vs. 9 % , p = 0.74 ) .


However , the target vessel revascularization rate was higher in the PCI group ( 20 % vs. 1.5 % ; p < 0.001 ) .


Clinical symptoms and quality of life improved significantly from baseline with both interventions and were similar in magnitude between groups .


At 7-year follow-up , PCI by SES and MIDCAB in isolated proximal left anterior descending lesions yielded similar long-term outcomes regarding the primary composite clinical endpoint and quality of life .


Target vessel revascularization was more frequent in the PCI group .


( MIDCAB Versus DES in Proximal LAD Lesions ; NCT00299429 ) .


This 2-arm , phase 1 , crossover study compared the relative bioavailability of two dovitinib ( TKI258 ) capsule formulations [ anhydrate clinical service form ( CSF ) and monohydrate final market image ( FMI ) ; Arm 1 ] and determined the effect of food on dovitinib exposure ( Arm 2 ) .


Patients with advanced solid tumors were enrolled in one of the 2 arms .


Arm 1 randomized patients to a single 500-mg dose of either CSF or FMI followed by 7 days of rest and 500 mg of the other formulation .


Arm 2 patients received 300 mg of FMI once daily and were randomized to follow one of six meal sequences , each with three prandial conditions : low fat ( LF ) , high fat ( HF ) , or no meal ( NM ) .


Twenty-three and 37 patients were enrolled and 19 and 21 were evaluable in Arms 1 and 2 , respectively .


In Arm 1 , the adjusted geometric means for FMI had small reductions relative to CSF [ area under the plasma concentration-time curve ( AUClast ) decreased by 12 % , maximum concentration ( C max ) decreased by 3 % ] .


In Arm 2 , the HF meal versus NM showed a 2 % increase in the adjusted geometric mean for AUClast and a 5 % decrease for C max .


The LF meal versus NM comparison showed 9 and 6 % increases for AUClast and C max , respectively .


Overall , common adverse events included nausea , vomiting , diarrhea , and fatigue .


Systemic exposure to dovitinib was similar for the FMI and CSF capsule formulations .


Additionally , since prandial conditions did not affect the systemic exposure , dovitinib can be taken with or without food .


To determine whether 17 alpha-hydroxyprogesterone caproate ( 17OHPC ) prolongs gestation beyond 37 weeks of gestation ( primary outcome ) and reduces neonatal morbidity ( secondary outcome ) in twin pregnancy .


Randomised controlled double-blind clinical trial .


Tertiary-care university medical centre .


Unselected women with twin pregnancies .


Participants received weekly injections of 250 mg 17OHPC ( n = 194 ) or placebo ( n = 94 ) , from 16-20 to 36 weeks of gestation .


Randomisation was performed using the permuted-block randomisation method .


Data were analysed on an intention-to-treat basis .


Preterm birth ( PTB ) rate before 37 weeks of gestation .


There were no significant differences in the average gestational age at delivery , or in the rates of PTB before 37 , 32 , and 28 weeks of gestation , between the two groups .


The proportion of very-low-birthweight neonates ( < 1500 g ) was significantly lower in the 17OHPC group ( 7.6 % ) compared with placebo ( 14.3 % ) ( relative risk , RR 0.5 ; 95 % confidence interval , 95 % CI 0.3-0 .9 ; P = 0.01 ) .


Progestogen-treated neonates had a significantly lower composite neonatal morbidity ( 19.1 % ) compared with placebo ( 30.9 % ) ( odds ratio , OR 0.53 ; 95 % CI 0.31-0 .90 ; P = 0.02 ) , with significantly lower odds for respiratory distress syndrome ( 14.4 versus 23.4 % ; OR 0.55 ; 95 % CI 0.31-0 .98 ; P = 0.04 ) , retinopathy of prematurity ( 1.1 versus 4.6 % ; OR 0.21 ; 95 % CI 0.05-0 .96 ; P = 0.04 ) , and culture-confirmed sepsis ( 3.4 versus 12.8 % ; OR 0.24 ; 95 % CI 0.10-0 .57 ; P = 0.00 ) .


Intramuscular 17OHPC therapy did not reduce PTB before 37 weeks of gestation in unselected twin pregnancies .


Nonetheless , 17OHPC significantly reduced neonatal morbidity parameters and increased birthweight .


To assess treatment satisfaction with tadalafil or tamsulosin vs placebo in a 12-week , randomised , double-blind study of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( LUTS/BPH ) .


After a 4-week placebo lead-in period , men aged 45 years with an International Prostate Symptom Score ( IPSS ) of 13 and a maximum urinary flow rate of 4 to 15mL/s received placebo ( 172 men ) , tadalafil 5mg ( 171 ) , or tamsulosin 0.4 mg ( 168 ) once daily for 12 weeks .


Treatment Satisfaction Scale-BPH ( TSS-BPH ) responses were assessed based on median treatment differences using the van Elteren test .


Overall treatment satisfaction was greater for tadalafil vs placebo ( P = 0.005 ) , based on greater satisfaction with efficacy ( P = 0.003 ) ; neither overall treatment satisfaction nor satisfaction with efficacy was greater for tamsulosin vs placebo ( P 0.409 ) .


For individual questions , 66.5 % of men rated tadalafil treatment as ` effective/very effective ' ( Question 1 , Q1 ) vs placebo ( P = 0.011 ) , 72.6 % would ` definitely/probably recommend their treatment ' ( Q3 ; P = 0.043 ) , 71.8 % were generally ` very satisfied/satisfied with their medication ' ( Q8 ; P < 0.003 ) , and 65.0 % would ` definitely/probably continue therapy ' ( Q10 ; P = 0.035 ) .


With tamsulosin , differences vs placebo were not statistically significant .


Subgroup analyses of overall TSS-BPH by baseline age ( 65 / > 65 years ) , history of erectile dysfunction ( yes/no ) , LUTS/BPH severity ( IPSS < / 20 ) , total testosterone level ( < 300/300ng/dL ) , and age-specific predicted prostate volume ( < 40/40mL ) showed no statistically significant treatment-subgroup interactions .


Men with recent prior - blocker therapy reported greater treatment satisfaction with tadalafil vs placebo , with only borderline difference for men without prior therapy .


Treatment satisfaction was greater with tadalafil vs placebo , with no significant difference between tamsulosin and placebo .


The potential negative influence of angiogenic gene therapy on the development or progression of retinal pathologies such as diabetic retinopathy ( DR ) or age-related macular degeneration ( AMD ) has led to the systematic exclusion of affected patients from trials .


We investigated the role of nonviral fibroblast factor 1 ( NV1FGF ) in two phase II , multinational , double-blind , randomized , placebo-controlled , gene therapy trials ( TALISMAN 201 and 211 ) .


One hundred and fifty-two subjects with critical limb ischemia or claudication were randomized to receive eight intramuscular injections of 2.5 ml of NV1FGF at 0.2 mg/ml or 0.4 mg/dl or placebo .


One hundred and fifty-two patients received a plasmid dose of NV1FGF of up to 32 mg or placebo .


All patients underwent a systematic ophthalmologic examination at baseline and at 3 , 6 or 12 months following gene therapy .


Twenty-six of these patients ( Mnster subgroup ) received a retinal fluorescence angiography at baseline and at final examination .


Among those 26 patients , four of nine patients with diabetes suffered from nonproliferative DR. Three patients showed non-exsudative AMD .


No change of retinal morphology or function was observed in Mnster subgroup of both TALISMAN trials independent of the intramuscular NV1FGF dosage applied .


Angiogenic gene therapy using NV1FGF is safe even in diabetics .


We used the Western Denmark Heart Registry to assess one-year and long-term all-cause mortality and stent failure following Percutaneous Coronary Intervention ( PCI ) with drug-eluting stents ( DES ) or bare-metal stents ( BMS ) .


The use of DES compared with BMS during PCI has reduced the risk of restenosis in native coronary artery lesions .


In saphenous vein grafts ( SVG ) the outcome after DES compared with BMS is insufficiently described .


From January 1 , 2002 to December 31 , 2010 all patients with PCI of SVG lesions were identified among 3.0 million inhabitants .


Stent failure was defined as clinically driven target lesion revascularization , graft occlusion without intervention , or stent thrombosis .


The study cohort consisted of 529 patients with 755 SVG lesions ( 348 DES patients with 510 lesions and 181 BMS patients with 245 lesions ) .


Mean age did not differ between patients with DES-treated lesions compared to patients with BMS-treated lesions ( 67.5 9.1 years vs. 67.6 9.3 years ; P = 0.85 ) .


The median follow-up time was 3.0 years ( 25th-75th percentile : 1.4-5 .1 years ) .


One-year ( n = 27 ( 8.2 % ) vs. n = 12 ( 6.7 % ) , log rank P = 0.60 ) and 3-year cumulative mortality ( n = 31 ( 18.8 % ) vs. n = 59 ( 21.8 % ) , log rank P = 0.64 ) did not differ significantly between DES - and BMS-treated patients .


One-year cumulative stent failure was seen in 39 ( 6.6 % ) DES-treated lesions vs. 24 ( 10.8 % ) BMS-treated lesions ( P = 0.088 ) , and 3-year cumulative stent failure in 48 ( 15.4 % ) vs. 34 ( 18.8 % ) lesions ( P = 0.25 ) , respectively .


In SVG lesions , DES showed no long-term benefit compared to BMS in rates of all-cause mortality or stent failure .


Implementing optimal lung cancer screening programs requires knowledge of the natural history and detectability of lung cancer .


This information can be derived from the results of clinical trials with the aid of microsimulation models .


Data from the Surveillance , Epidemiology , and End Results ( SEER ) program and individual-level data from the National Lung Screening Trial ( NLST ) and the Prostate , Lung , Colon , and Ovarian Cancer Screening trial ( PLCO ) were used to investigate the sensitivity ( by histology and stage ) of CT and chest radiography ( CXR ) and the mean preclinical sojourn time ( MPST ) of lung cancer ( by gender , histology , and stage ) .


The MISCAN-Lung model was used to reproduce the lung cancer incidence by method of detection ( clinically or screen-detected ) , gender , histology , and stage in both trials and SEER , by calibrating CT and CXR sensitivity and natural history parameters .


CT sensitivity ranges from 8.83 % to 99.35 % and CXR sensitivity from 2.51 % to 97.31 % , depending on histology and stage .


CT sensitivity for stage IA is more than 3-fold higher compared with CXR , for all histologies .


The total MPST estimates for lung cancer progressing through preclinical stages IA to IV range from 3.09 to 5.32 years for men and 3.35 to 6.01 years for women .


The largest difference in total MPST between genders was estimated for adenocarcinoma .


We estimate longer MPSTs for lung cancer compared with previous research , suggesting a greater window of opportunity for lung cancer screening .


This study provides detailed insights into the natural history of lung cancer and CT screening effectiveness .


Ruxolitinib , a Janus kinase ( JAK ) 1 and 2 inhibitor , was shown to have a clinical benefit in patients with polycythemia vera in a phase 2 study .


We conducted a phase 3 open-label study to evaluate the efficacy and safety of ruxolitinib versus standard therapy in patients with polycythemia vera who had an inadequate response to or had unacceptable side effects from hydroxyurea .


We randomly assigned phlebotomy-dependent patients with splenomegaly , in a 1:1 ratio , to receive ruxolitinib ( 110 patients ) or standard therapy ( 112 patients ) .


The primary end point was both hematocrit control through week 32 and at least a 35 % reduction in spleen volume at week 32 , as assessed by means of imaging .


The primary end point was achieved in 21 % of the patients in the ruxolitinib group versus 1 % of those in the standard-therapy group ( P < 0.001 ) .


Hematocrit control was achieved in 60 % of patients receiving ruxolitinib and 20 % of those receiving standard therapy ; 38 % and 1 % of patients in the two groups , respectively , had at least a 35 % reduction in spleen volume .


A complete hematologic remission was achieved in 24 % of patients in the ruxolitinib group and 9 % of those in the standard-therapy group ( P = 0.003 ) ; 49 % versus 5 % had at least a 50 % reduction in the total symptom score at week 32 .


In the ruxolitinib group , grade 3 or 4 anemia occurred in 2 % of patients , and grade 3 or 4 thrombocytopenia occurred in 5 % ; the corresponding percentages in the standard-therapy group were 0 % and 4 % .


Herpes zoster infection was reported in 6 % of patients in the ruxolitinib group and 0 % of those in the standard-therapy group ( grade 1 or 2 in all cases ) .


Thromboembolic events occurred in one patient receiving ruxolitinib and in six patients receiving standard therapy .


In patients who had an inadequate response to or had unacceptable side effects from hydroxyurea , ruxolitinib was superior to standard therapy in controlling the hematocrit , reducing the spleen volume , and improving symptoms associated with polycythemia vera .


( Funded by Incyte and others ; RESPONSE ClinicalTrials.gov number , NCT01243944 . )


This pilot study investigated the efficacy of a novel virtual reality-cognitive rehabilitation ( VR-CR ) intervention to improve contextual processing of objects in children with autism .


Previous research supports that children with autism show deficits in contextual processing , as well as deficits in its elementary components : abstraction and cognitive flexibility .


Four children with autism participated in a multiple-baseline , single-subject study .


The children were taught how to see objects in context by reinforcing attention to pivotal contextual information .


All children demonstrated statistically significant improvements in contextual processing and cognitive flexibility .


Mixed results were found on the control test and changes in context-related behaviours .


Larger-scale studies are warranted to determine the effectiveness and usability in comprehensive educational programs .


During the ACCORD 12 randomized trial , an evaluation of the clinical tumor response was prospectively performed after neoadjuvant chemoradiotherapy .


The correlations between clinical complete response and patient characteristics and treatment outcomes are reported .


Between 2005 and 2008 the Accord 12 trial accrued 598 patients with locally advanced rectal cancer and compared two different neoadjuvant chemoradiotherapies ( Capox 50 : capecitabine + oxaliplatin +50 Gy vs Cap 45 : capecitabine +45 Gy ) .


An evaluation of the clinical tumor response with rectoscopy and digital rectal examination was planned before surgery .


A score to classify tumor response was used adapted from the RECIST definition : complete response : no visible or palpable tumor ; partial response , stable and progressive disease .


The clinical tumor response was evaluable in 201 patients .


Score was : complete response : 8 % ( 16 patients ) ; partial response : 68 % ( 137 patients ) ; stable : 21 % ; progression : 3 % .


There was a trend toward more complete response in the Capox 50 group ( 9.3 % vs 6.7 % with Cap 45 ) .


In the whole cohort of 201 pts complete response was significantly more frequent in T2 tumors ( 28 % ; p = 0.025 ) ; tumors < 4cm in diameter ( 14 % ; p = 0.017 ) , less than half rectal circumference and with a normal CEA level .


Clinical complete response observed in 16 patients was associated with more conservative treatment ( p = 0.008 ) : 2 patients required an abdomino-perineal resection , 11 an anterior resection and 3 patients benefited from organ preservation ( 2 local excision , 1 `` watch and wait '' .


A complete response was associated with more ypT0 ( 73 % ; p < 0.001 ) ; ypNO ( 92 % ) ; R0 circumferential margin ( 100 % ) .


These data support the hypothesis that a clinical complete response assessed using rectoscopy and digital rectal examination after neoadjuvant therapy may increase the chance of a sphincter or organ preservation in selected rectal cancers .


New direct-acting antiviral agents are currently being developed to treat chronic HCV .


The efficacy and safety of daclatasvir combined with peginterferon alfa-2a ( alfa-2a ) and ribavirin were assessed in a randomized , double-blind Phase IIa study of Japanese patients with chronic HCV genotype-1 infection .


Japanese patients who were treatment-naive ( n = 25 ) or prior null ( n = 12 ) or partial ( n = 5 ) responders received once-daily daclatasvir 10 mg or 60 mg or placebo in combination with alfa-2a and ribavirin .


Daclatasvir recipients with a protocol-defined response ( HCV RNA < 15 IU/ml at week 4 and undetectable at week 12 ) were treated for 24 weeks ; placebo recipients and patients without a protocol-defined response were treated for 48 weeks .


Sustained virological response at 24 weeks post-treatment ( SVR24 ) was achieved by 89 % and 100 % of treatment-naive patients receiving daclatasvir 10 mg and 60 mg , respectively , versus 75 % in placebo recipients .


Virological failure was more frequent in prior non-responder patients , with 50 % and 78 % achieving SVR24 in daclatasvir 10 mg and 60 mg groups , respectively .


Adverse events occurred with similar frequency among treatment groups and were consistent with the adverse event profile of alfa-2a / ribavirin alone .


The most commonly reported adverse events included pyrexia , alopecia , anaemia , lymphopenia , neutropenia , pruritus and diarrhoea .


Three patients discontinued treatment due to anaemia .


Daclatasvir combined with alfa-2a / ribavirin in treatment-naive patients showed greater efficacy than alfa-2a / ribavirin alone and was generally well tolerated .


The 60-mg dose of daclatasvir achieved the highest rates of SVR24 in both treatment-naive and non-responder populations and will be evaluated in a Phase III clinical trial .


To investigate the effect of abstention from breastfeeding , for an hour before and after each vaccination , on the immune responses of infants to two doses of rotavirus vaccine .


In Soweto , South Africa , mother-infant pairs who were uninfected with human immunodeficiency virus ( HIV ) were enrolled as they presented for the `` 6-week '' immunizations of the infants .


Each infant was randomly assigned to Group 1 - in which breastfeeding was deferred for at least 1 h before and after each dose of rotavirus vaccine - or Group 2 - in which unrestricted breastfeeding was encouraged .


Enzyme-linked immunosorbent assays were used to evaluate the titres of rotavirus-specific IgA in samples of serum collected from each infant immediately before each vaccine dose and 1 month after the second dose .


Among the infants , a fourfold or greater increase in titres of rotavirus-specific IgA following vaccination was considered indicative of seroconversion .


The evaluable infants in Group 1 ( n = 98 ) were similar to those in Group 2 ( n = 106 ) in their baseline demographic characteristics and their pre-vaccination titres of anti-rotavirus IgA .


After the second vaccine doses , geometric mean titres of anti-rotavirus IgA in the sera of Group-1 infants were similar to those in the sera of Group-2 infants ( P = 0.685 ) and the frequency of seroconversion in the Group-1 infants was similar to that in the Group-2 infants ( P = 0.485 ) .


Among HIV-uninfected South African infants , abstention from breastfeeding for at least 1 h before and after each vaccination dose had no significant effect on the infants ' immune response to a rotavirus vaccine .


To determine long-term outcomes in a clinical trial evaluating the role of taxane type and schedule in operable breast cancer and evaluate the impact of obesity and black race on outcome .


A total of 4,954 eligible women with stage II to III breast cancer treated with four cycles of doxorubicin plus cyclophosphamide were randomly assigned to receive paclitaxel or docetaxel every 3 weeks for four doses or weekly for 12 doses using a 2 2 factorial design .


The primary end point was disease-free survival ( DFS ) .


Results are expressed as hazard ratios ( HRs ) from Cox proportional hazards models .


All P values are two sided .


When compared with the standard every-3-week paclitaxel arm , after a median follow-up of 12.1 years , DFS significantly improved and overall survival ( OS ) marginally improved only for the weekly paclitaxel ( HR , 0.84 ; P = .011 and HR , 0.87 ; P = .09 , respectively ) and every-3-week docetaxel arms ( HR , 0.79 ; P = .001 and HR , 0.86 ; P = .054 , respectively ) .


Weekly paclitaxel improved DFS and OS ( HR , 0.69 ; P = .010 and HR , 0.69 ; P = .019 , respectively ) in triple-negative breast cancer .


For hormone receptor-positive , human epidermal growth factor receptor 2-nonoverexpressing disease , no experimental arm improved OS , and black race and obesity were associated with increased risk of breast cancer recurrence and death .


Improved outcomes initially observed for weekly paclitaxel were qualitatively similar but quantitatively less pronounced with longer follow-up , although exploratory analysis suggested substantial benefit in triple-negative disease .


Further research is required to understand why obesity and race influence clinical outcome in hormone receptor-positive disease .


Immune intervention trials in recent-onset type 1 diabetes would benefit from biomarkers associated with good therapeutic response .


In the previously reported randomized placebo-controlled anti-CD3 study ( otelixizumab ; GlaxoSmithKline ) , we tested the hypothesis that specific diabetes autoantibodies might serve this purpose .


In the included patients ( n = 40 otelixizumab , n = 40 placebo ) , - cell function was assessed as area under the curve ( AUC ) C-peptide release during a hyperglycemic glucose clamp at baseline ( median duration of insulin treatment : 6 days ) and every 6 months until 18 months after randomization .


( Auto ) antibodies against insulin ( I [ A ] A ) , GAD ( GADA ) , IA-2 ( IA-2A ) , and ZnT8 ( ZnT8A ) were determined on stored sera by liquid-phase radiobinding assay .


At baseline , only better preserved AUC C-peptide release and higher levels of IAA were associated with better preservation of - cell function and lower insulin needs under anti-CD3 treatment .


In multivariate analysis , IAA ( P = 0.022 ) or the interaction of IAA and C-peptide ( P = 0.013 ) independently predicted outcome together with treatment .


During follow-up , good responders to anti-CD3 treatment ( i.e. , IAA ( + ) participants with relatively preserved - cell function [ 25 % of healthy control subjects ] ) experienced a less pronounced insulin-induced rise in I ( A ) A and lower insulin needs .


GADA , IA-2A , and ZnT8A levels were not influenced by anti-CD3 treatment , and their changes showed no relation to functional outcome .


There is important specificity of IAA among other diabetes autoantibodies to predict good therapeutic response of recent-onset type 1 diabetic patients to anti-CD3 treatment .


If confirmed , future immune intervention trials in type 1 diabetes should consider both relatively preserved functional - cell mass and presence of IAA as inclusion criteria .


The aim of this study was to evaluate the efficacy of a 9-day accommodation protocol on reducing perceived discomfort while sitting on a stability ball ( SB ) ; trunk muscle activity levels and lumbar spinal postures were also considered .


Previous studies have compared SB sitting with office chair sitting with few observed differences in muscle activity or posture ; however , greater discomfort during SB sitting has been reported .


These findings may indicate an accommodation period is necessary to acclimate to SB sitting .


For this study , 6 males and 6 females completed two separate , 2-hr sitting sessions on an SB .


Half the participants completed a 9-day accommodation period between the visits , whereas the other half did not use an SB during the time .


On both occasions , self-reported perceived discomfort ratings were collected along with erector spinae and abdominal muscle activity and lumbar spinal postures .


Discomfort ratings were reduced in female participants following the accommodation ; no effects on muscle activation or lumbar spine postures were observed .


Accommodation training may reduce perceived low-back discomfort in females.Trunk muscle activity and lumbar spine postures during seated office work on an SB did not differ between groups ; however , greater sample power was required to conclusively address these variables .


Regarding whether to use an SB in place of a standard office chair , this study indicates that females electing to use an SB can decrease discomfort by following an accommodation protocol ; no evidence was found to indicate that SB chair use will improve trunk strength or posture , even following an accommodation period .


Dietary fiber ( DF ) intake in American children is suboptimal , increasing the risk of GI distress and contributing to poor diet quality .


The objective of this study was to determine the effect of introducing two high-fiber snacks per day on gastrointestinal function as well as nutrient and food group intake in healthy children ages 7-11years old .


This study was a randomized controlled prospective intervention study of children 7-11years of age ( n = 81 ) attending a rural Midwestern elementary school .


Children were randomized by classroom to consume two high-fiber snacks per day ( total of 10-12g DF ) or their usual snacks for 8weeks .


Participants completed two 24-hour dietary recalls and a questionnaire about their GI health at baseline , mid-intervention ( week 4 ) , and post-intervention .


Dietary data was entered into NDSR 2011 and t-tests utilized to assess changes .


Analyses were completed in SAS 9.2 .


Children consumed at least half their snack 94 % of the time when a snack was chosen ( 89 % of time ) .


Participants in both the intervention and control group had healthy scores on the GI health questionnaire at all time points .


The intervention group increased DF ( P = 0.0138 ) and whole grain ( WG ) intake ( P = 0.0010 ) at mid-intervention but after the intervention returned to their baseline DF intake ( P = 0.2205 ) and decreased their WG intake ( P = 0.0420 ) compared to baseline .


Eating high-fiber snacks increased DF intake by 2.5 g per day ( 21 % increase ) , suggesting displacement of other fiber-rich foods .


Study results indicate that children accept high-fiber foods , thus making these high-fiber foods and snacks consistently available will increase DF intake .


With the safety of laparoscopic cholecystectomy ( LC ) having been established , the current stress is on reducing the postoperative morbidity associated with this procedure .


Hence , this study was undertaken to compare the effect of low-pressure ( 8 mm Hg ) ( LPLC ) versus standard-pressure ( 12 mm Hg ) ( SPLC ) pneumoperitoneum on postoperative pain , respiratory and liver functions , the stress response , and the intraoperative surgeon comfort in patients undergoing LC .


Patients undergoing LC ( n = 43 ) were randomized into the LPLC ( 8 mm Hg ) group ( n = 22 ) and the SPLC ( 12 mm Hg ) group ( n = 21 ) .


Postoperative pain , changes in liver function , peak expiration flow rate , C-reactive protein level , and intraoperative surgeon comfort were assessed .


The postoperative pain scores ( P = 0.003 , 0.000 , 0.001 , and 0.002 at 0 , 4 , 8 , and 24 h ) , total analgesic requirement ( P = 0.001 ) , and the number ( total and good ) of demands for analgesic in the first 24 hours ( P = 0.002 and 0.001 ) were lower in the LPLC group .


The surgeon comfort in the LPLC group was significantly lesser ( P = 0.000 ) .


The liver function and peak expiration flow rate did not show any significant changes .


C-reactive protein levels varied significantly only at 24 hours postoperatively ( P = 0.001 ) .


The use of low-pressure pneumoperitoneum ( 8 mm Hg ) for LC is associated with a significantly lower postoperative pain .


However , the use of this low-pressure pneumoperitoneum can jeopardize the surgeon 's comfort .


The 2009 KDIGO ( Kidney Disease : Improving Global Outcomes ) chronic kidney disease-mineral and bone disorder clinical practice guideline suggests correcting 25-hydroxyvitamin D3 ( 25 [ OH ] D ) levels < 30ng/mL in patients treated with maintenance hemodialysis , but does not provide a specific treatment protocol .


2-center , double-blind , randomized , 13-week , controlled trial followed by a 26-week open-label study .


55 adult maintenance hemodialysis patients with 25 ( OH ) D levels < 30ng/mL were recruited from June 2008 through October2009 .


Cholecalciferol , 25,000 IU , per week orally versus placebo for 13 weeks , then 26 weeks of individualized cholecalciferol prescription based on NKF-KDOQI ( National Kidney Foundation-Kidney Disease Outcomes Quality Initiative ) guidelines .


Primary end point was the percentage of patients with 25 ( OH ) D levels30ng/mL at 13 weeks .


Secondary outcomes included the percentage of patients with normal calcium , phosphorus , and intact parathyroidhormone ( iPTH ) blood levels .


Safety measures included incidence of hypercalcemia and hypervitaminosis D.


Blood calcium and phosphate were measured weekly ; iPTH , 25 ( OH ) D , 1,25-dihydroxyvitamin D3 ( 1,25 [ OH ] 2D ) , and bone turnover markers , trimonthly ; fetuin A and fibroblast growth factor 23 ( FGF-23 ) serum levels and aortic calcification scores were determined at weeks 0 and39 .


The primary end point significantly increased in the treatment group compared with the placebo group ( 61.5 % vs 7.4 % ; P < 0.001 ) , as well as 1,25 ( OH ) 2D levels ( 22.5 [ IQR , 15-26 ] vs 11 [ IQR , 10-15 ] pg/mL ; P < 0.001 ) and the proportion of patients achieving the target calcium level ( 76.9 % vs 48.2 % ; P = 0.03 ) .


Incidence of hypercalcemia and phosphate and iPTH levels were similar between groups .


The second 26-week study phase did not significantly modify the prevalence of 25 ( OH ) D level30ng/mL in patients issued from the placebo group .


Small size of the study population .


Oral weekly administration of 25,000 IU of cholecalciferol for 13 weeks is an effective , safe , inexpensive , and manageable way to increase 25 ( OH ) D and 1,25 ( OH ) 2D levels in hemodialysis patients .


Further evaluation of clinical end points is suggested .


Physical activity affords a wide range of physiological and psychological benefits for children and adolescents , yet many children with physical disabilities are insufficiently active to achieve these benefits .


The StepUp program is a newly developed 6-week pedometer-based self-management program for children and adolescents with physical disability .


Participants use a pedometer to undertake a 6-week physical activity challenge , with personalised daily step count goals set in consultation with a physiotherapist .


The study aims to evaluate the effectiveness of the StepUp program , using a randomised control trial design .


A target sample of 70 young people with physical disabilities ( aged 8-17 years , ambulant with or without aid , residing in Adelaide ) will be recruited .


Participants will be randomly allocated to either intervention or control following completion of baseline assessments .


Assessments are repeated at 8 weeks ( immediately post intervention ) and 20 weeks ( 12 weeks post intervention ) .


The primary outcome is objective physical activity determined from 7 day accelerometry , and the secondary outcomes are exercise intention , physical self-worth , quality of life and fatigue .


Analyses will be undertaken on an intention-to-treat basis using random effects mixed modelling .


This study will provide information about the potential of a low-touch and low-cost physical activity intervention for children and adolescents with cerebral palsy .


Australian New Zealand Clinical Trials Registry ( ANZCTR ) : ACTRN12613000023752 .


To assess the effect of virtual reality distraction on pain among patients with a hand injury undergoing a dressing change .


Virtual reality distraction can effectively alleviate pain among patients undergoing a dressing change .


Clinical research has not addressed pain control during a dressing change .


A randomised controlled trial was performed .


In the first dressing change sequence , 98 patients were randomly divided into an experimental group and a control group , with 49 cases in each group .


Pain levels were compared between the two groups before and after the dressing change using a visual analog scale .


The sense of involvement in virtual environments was measured using the Pearson correlation coefficient analysis , which determined the relationship between the sense of involvement and pain level .


The difference in visual analog scale scores between the two groups before the dressing change was not statistically significant ( t = 0196 , p > 005 ) , but the scores became statistically significant after the dressing change ( t = -30792 , p < 001 ) .


The correlation between the sense of involvement in a virtual environment and pain level during the dressing was statistically significant ( R ( 2 ) = 05538 , p < 005 ) .


Virtual reality distraction can effectively alleviate pain among patients with a hand injury undergoing a dressing change .


Better results can be obtained by increasing the sense of involvement in a virtual environment .


Virtual reality distraction can effectively relieve pain without side effects and is not reliant on a doctor 's prescription .


This tool is convenient for nurses to use , especially when analgesics are unavailable .


To compare the safety , efficacy , and impact on stent graft positioning between rapid artificial cardiac pacing ( RACP ) , induced hypotension and sodium nitroprusside ( SNP ) induced hypotension during thoracic endovascular aortic repair ( TEVAR ) for Stanford B aortic dissection .


One hundred and sixty-eight patients , who were diagnosed with Stanford B aortic dissection and who underwent selective TEVAR in Guangdong General Hospital and the People 's Hospital of Baoan District , Shenzhen , People 's Republic of China , were enrolled in this study .


Patients were randomly divided into a RACP group ( n = 77 ) and a SNP group ( n = 91 ) .


During localization and deployment of the stent graft , hypotension was induced by RACP or intravenous SNP , according to randomization .


Hemodynamics , landing precision ( deviation from planned placement site ) , duration of procedure , renal function , neurocognitive function , and incidence of endoleaks and paraplegia/hemiplegia were compared .


Except for methods of inducing hypotension , TEVAR was performed according to the same protocol in each group .


RACP was successfully performed in all patients assigned to the RACP group .


Compared with the SNP group , blood pressure was significantly lower ( 435 versus 816 mmHg , P = 0.003 ) and the restoration time of blood pressure and the operation duration were significantly shorter ( 72 versus 45187 seconds , P < 0.001 ; 8715 versus 10618 minutes , P < 0.001 , respectively ) in the RACP group .


Stent graft localization/deployment was more precise in the RACP group ( 21 versus 52 mm , P < 0.001 ) .


Compared to baseline , there was no significant change after TEVAR in either group in regard to renal function , neurocognitive function , and incidence of endoleaks and paraplegia/hemiplegia .


RACP can be safely applied to patients undergoing TEVAR for Stanford B dissection .


RACP can shorten the operation duration and facilitate precise graft localization/deployment .


Elevated intraocular pressure ( IOP ) is a well-known adverse event associated with the fluocinolone acetonide implant ( FAI ) , but no data are available regarding factors associated with increased risk of IOP elevation in patients treated with the FAI .


To report risk factors that may predispose patients to elevated IOP after treatment with the FAI .


Data from 3 multicenter , 3-year , prospective , randomized , phase 2b/3 clinical trials evaluating the safety and efficacy of the FAI were pooled and analyzed .


Patients had no underlying glaucoma and at least one eye with a history of recurrent noninfectious uveitis affecting the posterior segment .


Patients were treated with 1 or more of the following : systemic therapy ( corticosteroids or other immunosuppressive drugs ) for at least 3 months before enrollment , 2 or more sub-Tenon capsule corticosteroid injections for uveitis management during the 6 months before enrollment , or systemic corticosteroid or sub-Tenon capsule corticosteroid injection therapy required for at least 2 separate recurrences within 6 months before enrollment .


Factors evaluated as risk factors for IOP elevation included age , sex , lens status , uveitis severity at enrollment , and location of uveitis .


Data analyses were based on 641 eyes .


A total of 351 eyes did not receive the FAI , whereas 290 eyes had the 0.59-mg FAI placed .


An increase in IOP of 10 mm Hg or elevation to 30 mm Hg was seen in 60 untreated eyes ( 17.1 % ) and 188 treated eyes ( 65.1 % ) ( hazard ratio , 5.80 ; 95 % CI , 4.28-7 .70 ; P < .001 ) .


A total of 8 untreated eyes ( 2.3 % ) required surgical intervention for elevated IOP compared with 93 treated eyes ( 32.1 % ) ( hazard ratio , 16.48 ; 95 % CI , 8.24-32 .96 ; P < .001 ) .


In patients with the FAI , younger age , male sex , and phakic lens status were associated with higher risk of IOP elevation and the need for glaucoma surgery ( P = .003 , P < .001 , and P < .001 , respectively ) .


Patients receiving the FAI are at higher risk of developing an IOP increase of 10 mm Hg or an absolute IOP of 30 mm Hg when compared with patients without the FAI .


Patients who are male , younger , and phakic are at an even higher risk for elevated IOP and possibly glaucoma surgery .


Liver abscess is a rare but potentially fatal complication of transarterial chemoembolization .


Other than for biliary abnormalities , risk factors for liver abscess formation after transarterial chemoembolization have rarely been discussed .


To identify other risk factors of liver abscess after transarterial chemoembolization in patients with hepatocellular carcinoma .


Data for 5299 patients with hepatocellular carcinoma who underwent transarterial chemoembolization from July 1999 to December 2009 were retrospectively reviewed .


72 patients who experienced liver abscess after transarterial chemoembolization were enrolled as a case group , which was compared with a randomly selected control group ( n = 1009 ) of patients who did not develop liver abscess after transarterial chemoembolization .


Pneumobilia , type 2 biliary abnormality , type 1 biliary abnormality , diabetes mellitus , tumour number ( 3 ) , tumour size ( 3cm ) , and tumour necrosis on the pre-transarterial chemoembolization computed tomography , and gelfoam embolization and vessel injury during transarterial chemoembolization were all significant predisposing factors for liver abscess after transarterial chemoembolization .


A prediction model for postembolization liver abscess was developed from these risk factors .


The group of patients with risk scores greater than 71 showed a significantly increased risk of liver abscess after transarterial chemoembolization .


These high-risk patients should be monitored carefully after transarterial chemoembolization .


Vascular disease is included in a risk scoring system to predict stroke in patients with non-valvular atrial fibrillation ( AF ) .


This post hoc analysis of ROCKET AF aimed to determine the absolute rates of stroke and bleeding , and the relative effectiveness and safety of rivaroxaban vs. warfarin in patients with and without peripheral artery disease ( PAD ) .


Peripheral artery disease was defined on the case-report form as the presences of intermittent claudication , amputation for arterial insufficiency , vascular reconstruction , bypass surgery , or percutaneous intervention to the extremities , or previously documented abdominal aortic aneurysm .


ROCKET AF was a double-blind , double-dummy , randomized-controlled trial comparing rivaroxaban and warfarin for the prevention of stroke or systemic embolism .


A total of 839 ( 5.9 % ) patients in ROCKET AF had PAD .


Patients with and without PAD had similar rates of stroke or systemic embolism [ HR : 1.04 , 95 % CI ( 0.72 , 1.50 ) , P = 0.84 ] and major or non-major clinically relevant ( NMCR ) bleeding [ HR : 1.11 , 95 % CI ( 0.96 , 1.28 ) , P = 0.17 ] , respectively .


The efficacy of rivaroxaban when compared with warfarin for the prevention of stroke or systemic embolism was similar in patients with PAD ( HR : 1.19 , 95 % CI : 0.63-2 .22 ) and without PAD ( HR : 0.86 , 95 % CI : 0.73-1 .02 ; interaction P = 0.34 ) .


There was a significant interaction for major or NMCR bleeding in patients with PAD treated with rivaroxaban compared with warfarin ( HR : 1.40 , 95 % CI : 1.06-1 .86 ) compared with those without PAD ( HR : 1.03 , 95 % CI : 0.95-1 .11 ; interaction P = 0.037 ) .


Patients with PAD in ROCKET AF did not have a statistically significant higher risk of stroke or systemic embolism than patients without PAD , and there were similar efficacy outcomes in patients treated with rivaroxaban and warfarin .


In PAD patients , there was a higher risk of major bleeding or NMCR bleeding with rivaroxaban when compared with warfarin ( interaction P = 0.037 ) .


Further investigation is warranted to validate this subgroup analysis and determine the optimal treatment in this high-risk cohort of AF patients with PAD .


Family members of patients with coronary artery disease ( CAD ) have higher risk of vascular events .


We conducted a trial to determine if a family heart-health intervention could reduce their risk of CAD .


We assessed coronary risk factors and randomized 426 family members of patients with CAD to a family heart-health intervention ( n = 211 ) or control ( n = 215 ) .


The intervention included feedback about risk factors , assistance with goal setting and counselling from health educators for 12 months .


Reports were sent to the primary care physicians of patients whose lipid levels and blood pressure exceeded threshold values .


All participants received printed materials about smoking cessation , healthy eating , weight management and physical activity ; the control group received only these materials .


The main outcomes ( ratio of total cholesterol to high-density lipoprotein [ HDL ] cholesterol ; physical activity ; fruit and vegetable consumption ) were assessed at 3 and 12 months .


We examined group and time effects using mixed models analyses with the baseline values as covariates .


The secondary outcomes were plasma lipid levels ( total cholesterol , low-density lipoprotein cholesterol , HDL cholesterol and triglycerides ) ; glucose level ; blood pressure ; smoking status ; waist circumference ; body mass index ; and the use of blood pressure , lipid-lowering and smoking cessation medications .


We found no effect of the intervention on the ratio of total cholesterol to HDL cholesterol .


However , participants in the intervention group reported consuming more fruit and vegetables ( 1.2 servings per day more after 3 mo and 0.8 servings at 12 mo ; p < 0.001 ) .


There was a significant group by time interaction for physical activity ( p = 0.03 ) .


At 3 months , those in the intervention group reported 65.8 more minutes of physical activity per week ( 95 % confidence interval [ CI ] 47.0-84 .7 min ) .


At 12 months , participants in the intervention group reported 23.9 more minutes each week ( 95 % CI 3.9-44 .0 min ) .


A health educator-led heart-health intervention did not improve the ratio of total cholesterol to HDL cholesterol but did increase reported physical activity and fruit and vegetable consumption among family members of patients with CAD .


Hospitalization of a spouse , sibling or parent is an opportunity to improve cardiovascular health among other family members .


clinicaltrials.gov , no NCT00552591 .


To evaluate karyotype-specific ear and hearing problems in young-adult patients with Turner syndrome ( TS ) and assess the effects of previous treatment with oxandrolone ( Ox ) .


Double-blind follow-up study .


University hospital .


Sixty-five TS patients ( mean age , 24.3 yr ) previously treated with growth hormone combined with placebo , Ox 0.03 mg/kg per day , or Ox 0.06 mg/kg per day from the age of 8 years and estrogen from the age of 12 years .


Ear examination was performed according to standard clinical practice .


Air - and bone conduction thresholds were measured in decibel hearing level .


We compared patients with total monosomy of the short arm of the X chromosome ( Xp ) , monosomy 45 , X and isochromosome 46 , X , i ( Xq ) , with patients with a partial monosomy Xp , mosaicism or other structural X chromosomal anomalies .


We assessed the effect of previous Ox treatment .


Sixty-six percent of the patients had a history of recurrent otitis media .


We found hearing loss in 66 % of the ears , including pure sensorineural hearing loss in 32 % .


Hearing thresholds in patients with a complete monosomy Xp were about 10 dB worse compared with those in patients with a partial monosomy Xp .


Air - and bone conduction thresholds were not different between the placebo and Ox treatment groups .


Young-adult TS individuals frequently have structural ear pathology , and many suffer from hearing loss .


This indicates that careful follow-up to detect ear and hearing problems is necessary , especially for those with a monosomy 45 , X or isochromosome 46 , X , i ( Xq ) .


Ox does not seem to have an effect on hearing .


The aim was to investigate whether the fascia suture technique ( FST ) can reduce access closure time and procedural costs compared with the Prostar technique ( Prostar ) in patients undergoing endovascular aortic repair and to evaluate the short - and mid-term outcomes of both techniques .


In this two center trial , 100 patients were randomized to access closure by either FST or Prostar between June 2006 and December 2009 .


The primary endpoint was access closure time .


Secondary outcome measures included access related costs and evaluation of the short - and mid-term complications .


Evaluation was performed peri - and post-operatively , at discharge , at 30 days and at 6 months follow up .


The median access closure time was 12.4 minutes for FST and 19.9 minutes for Prostar ( p < .001 ) .


Prostar required a 54 % greater procedure time than FST , mean ratio 1.54 ( 95 % CI 1.25-1 .90 , p < .001 ) according to regression analysis .


Adjusted for operator experience the mean ratio was 1.30 ( 95 % CI 1.09-1 .55 , p = .005 ) and for patient body mass index 1.59 ( 95 % CI 1.28-1 .96 , p < .001 ) .


The technical failure rate for operators at proficiency level was 5 % ( 2/40 ) compared with 28 % ( 17/59 ) for those at the basic level ( p = .003 ) .


The proficiency level group had a technical failure rate of 4 % ( 1/26 ) for FST and 7 % ( 1/14 ) for Prostar , p = 1.00 , while corresponding rates for the basic level group were 27 % ( 6/22 ) for FST and 30 % ( 11/37 ) for Prostar ( p = .84 ) .


There was a significant difference in cost in favor of FST , with a median difference of 800 ( 95 % CI 710-927 , p < .001 ) .


In aortic endovascular repair FST is a faster and cheaper technique than the Prostar technique .


Correct use of intranasal corticosteroid ( INCS ) and compliance with treatment is very important for the treatment of allergic rhinitis ( AR ) .


An animated cartoon-aided teaching method for INCS administration was created to decrease the workload of health care professionals .


The aim of this study was to compare the performance of children with AR in using INCS between a group who were instructed using animated cartoon-aided teaching and those receiving only an oral presentation without demonstration .


The study was a prospective randomized controlled trial in children aged 5-16 years with moderate to severe intermittent or persistent AR who had never used INCS .


The patients were randomly divided into 2 groups ; 1 ) those receiving teaching about how to use INCS by an oral presentation without demonstration and 2 ) by animated cartoon-aided teaching .


The performance of the children was recorded after the initial training using a five-point checklist .


If they were unable to use the INCS correctly after the first teaching session , the same instructions were repeated and a second assessment was performed .


A total of 80 patients , 40 each group , underwent randomization .


The rate of achieving competency for the patients after the first instruction using the animated cartoon-aided teaching group was significantly higher than that for the oral presentation group ( 57.5 % VS 27.5 % ; P = 0.007 ) .


The cumulative success rate for the second assessment of the animated cartoon-aided group was also significantly higher than for those receiving only an oral presentation ( 95 % VS 60 % , P = 0.004 ) .


With regard to mastering the correct method for INCS usage , instruction using animated cartoon-aided teaching is better than oral presentation without demonstration .


However , the best method for teaching patients how to use INCS is a combination of oral explanation and demonstration by cartoon-aided teaching .


The teaching should be repeated periodically to remind patients of the correct method for INCS usage .


In rheumatoid arthritis ( RA ) and osteoarthritis ( OA ) forefoot involvement causes disability and metatarsalgia .


Our objective was to evaluate , in RA and OA patients , the efficacy of two protocols combining insoles in polypropylene terephtalate ( PPT ) and custom silicone orthoses for toes on disability and metatarsalgia .


Twenty-four women ( 13 with OA , 11 with RA ) with metatarsalgia were treated with two protocols : group A ( protocol A ) wore PPT insoles ( T1 ) for 30 days and for another 30 days silicone orthosis for toes were added ( T2 ) .


Group B ( protocol B ) wore PPT insoles and silicone orthosis ( T1 ) for 30 days and in the following 30 days only insoles ( T2 ) .


At T0 , T1 and T2 , pain , disability and function ( Foot Function Index - FFI ) , pressure ( KPA ) and plantar contact areas ( cm2 ) ( baropodometer ) , and gait spatial-temporal parameters ( GAITRite ) were assessed .


At T0 versus T2 , both protocols reduced FFI-pain , - disability and - functional limitation ( p < 0.05 ) , with better results of protocol A than protocol B ( p < 0.05 ) for FFI-pain and - disability .


Both protocols reduced baropodometer foot plantar pressures ( p < 0.001 ) , with better results for protocol A for right foot pressures ( p < 0.05 ) and increased foot contact areas ( p < 0.05 ) , with no difference between them ( p = NS ) .


Gait parameters were not significantly changed by both protocols ( p = NS ) .


In patients with RA and OA with metatarsalgia , the synergic action of silicone toe orthosis and PPT insoles improves FFI , reduces foot plantar pressures and increases foot plantar contact areas .


Protocol A , using firstly insoles and then adding silicone toe orthoses , is the more efficacious .


Persistent behavioural difficulties are common following paediatric acquired brain injury ( ABI ) .


Parents and families also experience heightened stress , psychological symptoms and burden , and there is evidence of a reciprocal relationship between parent and child functioning , which may be mediated by the adoption of maladaptive parenting practices .


Despite this , there is currently a paucity of research in family interventions in this population .


The aim of this study was to determine the efficacy of Stepping Stones Triple P : Positive Parenting Program ( SSTP ) , with an Acceptance and Commitment Therapy ( ACT ) workshop , in improving child outcomes and parenting practices following paediatric ABI .


Fifty-nine parents of children ( mean age 7 years , SD 3 years , 1 month ; 35 males , 24 females ) with ABI ( Traumatic injuries 58 % , Tumour 17 % , Encephalitis or meningitis 15 % , Cardiovascular accident 7 % , Hypoxia 3 % ) who were evidencing at least mild behaviour problems were randomly assigned to treatment or care-as-usual conditions over 10 weeks .


Mixed-model repeated-measures linear regression analyses were conducted to compare conditions from pre - to postintervention on child behavioural and emotional functioning ( Eyberg Child Behavior Inventory , Strengths and Difficulties Questionnaire ) and dysfunctional parenting style ( Parenting Scale ) .


Assessment of maintenance of change was conducted at a 6-month follow-up .


The trial was registered on Australian New Zealand Clinical Trials Registry ( ID : ACTRN12610001051033 , www.anzctr.org.au ) .


Significant time-by-condition interactions were identified on number and intensity of child behaviour problems , child emotional symptoms and parenting laxness and overreactivity , indicating significant improvements in the treatment condition , with medium-to-large effect sizes .


Most improvements were maintained at 6 months .


Group parenting interventions incorporating Triple P and ACT may be efficacious in improving child and parenting outcomes following paediatric ABI .


The purpose of this study is the comparison of the effect of vitamin B1 and fish oil with together on severity and duration of dysmenorrhea , and if it is effective , we can administrative both of them with less complication to compare with other chemical drugs which has many disadvantages .


High school of Urmia city , between March 2008 and June 2008 .


This study has a double-blind clinical trial design .240 high school female students with dysmenorrhea by a randomized Method were followed up in a double-blind , randomized , placebo-controlled study by dividing into four groups with 60 members .


The daily supplement was vit B1 ( 100 mg/day and fish oil pearl 500 mg/day ) , taken as a single dose starting at the beginning of the menstrual cycle and continued for 2 consecutive months .


Intensity of pain in three experimental groups ( Vit B1 , fish oil and both of them ) had significant difference comparing placebo group and intensity of pain had reduced .


( p < 0.001 ) , ( p = 0.018 ) , ( p < 0.001 ) VS in placebo group ( p = 0.79 ) .


Duration of pain had significantly reduced in all three experimental groups compared with placebo group .


( p = 0.004 ) , ( p = 0.008 ) , ( p < 0.001 ) VS in placebo group ( p = 0.32 ) .


In all of drugs , results ( mean ) was better at the end of the second month than the first month .


Fish oil and vit B1 effects on treatment of primary dysmenorrhea were similar , but vit B1 has less complications and it was more acceptable .


We mixed them and compared its results with vit B1 , fish oil and placebo separately .


Pain duration is the least in Vitamin B1 tablets compare with the others , but its duration was minimum in complex of Vitamin B1 tablets and fish oil capsules .


Due to good effects of vitamin B1 and fish oil on symptoms of dysmenorrhea , using of them is suggested .


Exercise using virtual reality ( VR ) has improved balance in adults with traumatic brain injury and community-dwelling older adults .


Rigorous randomized studies regarding its efficacy , safety , and applicability with individuals after stroke are lacking .


The purpose of this study was to determine whether an adjunct VR therapy improves balance , mobility , and gait in stroke rehabilitation inpatients .


A blinded randomized controlled trial studying 59 stroke survivors on an inpatient stroke rehabilitation unit was performed .


The treatment group ( n = 30 ) received standard stroke rehabilitation therapy plus a program of VR exercises that challenged balance ( eg , soccer goaltending , snowboarding ) performed while standing .


The control group ( n = 29 ) received standard stroke rehabilitation therapy plus exposure to identical VR environments but whose games did not challenge balance ( performed in sitting ) .


VR training consisted of 10 to 12 thirty-minute daily sessions for a 3-week period .


Objective outcome measures of balance and mobility were assessed before , immediately after , and 1 month after training .


Confidence intervals and effect sizes favored the treatment group on the Timed Up and Go and the Two-Minute Walk Test , with both groups meeting minimal clinical important differences after training .


More individuals in the treatment group than in the control group showed reduced impairment in the lower extremity as measured by the Chedoke McMaster Leg domain ( P = 0.04 ) immediately after training .


This VR exercise intervention for inpatient stroke rehabilitation improved mobility-related outcomes .


Future studies could include nonambulatory participants as well as the implementation strategies for the clinical use of VR .


http://www.ANZCTR.org.au/ .


Unique identifier : ACTRN12613000710729 .


Amino-acid-based formulas ( AAFs ) are recommended for children with cow 's milk protein allergy ( CMPA ) failing to respond to extensively hydrolyzed formulas ( eHFs ) .


This study aimed to assess the tolerance/hypoallergenicity and efficacy of a thickened AAF ( TAAF ) in these infants .


This multicenter , double-blind , randomized controlled trial ( NCT01940068 ) compared 3-month feeding with a pectin-based TAAF ( Novalac ( ) , United Pharmaceuticals , Paris , France ) and a commercially available `` reference '' AAF ( RAAF ; Neocate ( ) , Nutricia , Germany ) in infants aged < 18 months with CMPA and persistent allergy symptoms with eHF feeding .


Reported here are the results of an interim analysis after 1 month of feeding .


Of the 86 infants randomized , CMPA with eHF intolerance was confirmed in 75 infants ; all of them tolerated the allocated AAFs .


The major allergic symptom disappeared within 1 month in 61.9 and 51.5 % and regurgitations disappeared in 66.7 and 42.3 % of infants who received TAAF and RAAF , respectively .


Infants had significantly more normal stools ( soft or formed consistency ) with the TAAF ( 90.5 vs. 66.7 % ; p = 0.011 ) .


From baseline , daily family life significantly improved with both AAFs : crying time decreased by 97.3 ( p < 0.001 ) and 28.6 min ( p = 0.014 ) and sleeping time increased by 64.6 ( p = 0.009 ) and 29.0 min with TAAF and RAAF , respectively .


At day 30 , weight and body mass index z-score gains were 0.1 and 0.2 with TAAF and 0.2 and 0.0 with RAAF .


Both AAFs were well tolerated by infants with CMPA and eHF intolerance and ensured appropriate growth , with the TAAF providing additional comfort .


The aim of this study was to investigate the influence of perioperative N-acetylcysteine ( NAC ) administration , a known antioxidant , on the incidence of acute kidney injury ( AKI ) after off-pump coronary bypass surgery ( OPCAB ) in patients with known risk factors of AKI .


One hundred and seventeen patients with 1 of the following risk factors of AKI were randomized into either the control ( n = 57 ) or the NAC ( n = 60 ) group ; ( i ) preoperative serum creatinine > 1.4 mg/dL ; ( ii ) left ventricular ejection fraction < 35 % or congestive heart failure ( iii ) age > 70 years ( iv ) diabetes or ( v ) re-operation .


Patients in the NAC group received 150mg/kg of NAC IV bolus at anaesthetic induction followed by a continuous infusion at 150mg/kg per day for 24h .


AKI was diagnosed based on Acute Kidney Injury Network criteria during 48h postoperatively .