On multiple linear regression , duration of drains in the harmonic dissection group was 4.5 days less than electrocautery ( r2 = 0.28 , = 11.8 , p < 0.001 ) .


The harmonic scalpel significantly reduces postoperative discomfort and morbidity to the patient without increasing operating time .


We thus recommend preferential use of harmonic dissection in modified radical mastectomy .


( ClinicalTrials.gov NCT01587248 ) .


The prevalence of metabolic syndrome ( MetS ) and obesity has increased worldwide , as well as in Taiwan , particularly in women aged > 40 years .


The purpose of this study was to elucidate the effects of a calorie-restriction diet ( CR ) supplemented with protein and n-3 polyunsaturated fatty acids ( PUFAs ) on women with MetS .


A total of 143 eligible female participants were recruited and assigned to four dietary interventions such as 1500-kcal CR , calorie-restriction meal-replacement diet ( CRMR ) , calorie-restriction diet with fish oil supplementation ( CRF ) and calorie-restriction meal-replacement diet with fish oil supplementation ( CRMRF ) .


The changes in anthropometric measures , metabolic profiles , inflammatory response and the Z-score of severity of MetS were evaluated .


Among 143 female MetS patients enrolled , 136 patients completed the 12-week study .


After the 12-week dietary interventions , we observed reductions in body weight ( BW ) , body mass index ( BMI ) and waist circumference ( WC ) in all groups .


BMI and triglyceride ( TG ) levels decreased significantly in the CRMR , CRF and CRMRF groups , but not in the CR group .


The homeostasis model assessment of insulin resistance ( HOMA-IR ) had significantly improved in all four groups , and the levels of interleukin-6 ( IL-6 ) and C-reactive protein ( CRP ) had significantly decreased in the CRF and CRMRF groups .


Following the interventions , the changes in waist circumference ( WC ) , mean arterial pressure ( MAP ) , fasting blood glucose ( FBG ) , TGs , HOMA-IR , CRP and IL-6 significantly correlated with the reductions in Z-score of MetS severity .


Our study results indicate that a calorie-restriction dietary intervention combined with various macronutrients can reduce the severity of MetS in women and increase recovery from MetS by almost twofold in comparison with a CR alone .


Driving is a complex task and distractions such as using a mobile phone for the purpose of text messaging are known to have a significant impact on driving .


Eating and drinking are common forms of distraction that have received less attention in relation to their impact on driving .


The aim of this study was to further explore and compare the effects of a variety of distraction tasks ( i.e. , text messaging , eating , drinking ) on simulated driving .


Twenty-eight healthy individuals ( 13 female ) participated in a crossover design study involving 3 experimental trials ( separated by 24 h ) .


In each trial , participants completed a baseline driving task ( no distraction ) before completing a second driving task involving one of 3 different distraction tasks ( drinking 400 mL water , drinking 400 mL water and eating a 6-inch Subway sandwich , drinking 400 mL water and composing 3 text messages ) .


Primary outcome measures of driving consisted of standard deviation of lateral position ( SDLP ) and reaction time to auditory and visual critical events .


Subjective ratings of difficulty in performing the driving tasks were also collected at the end of the study to determine perceptions of distraction difficulty on driving .


Driving tasks involving texting and eating were associated with significant impairment in driving performance measures for SDLP compared to baseline driving ( 46.0 0.08 vs. 41.3 0.06 cm and 44.8 0.10 vs. 41.6 0.07 cm , respectively ) , number of lane departures compared to baseline driving ( 10.9 7.8 vs. 7.6 7.1 and 9.4 7.5 vs. 7.1 7.0 , respectively ) , and auditory reaction time compared to baseline driving ( 922 95 vs. 889 104 ms and 933 101 vs. 901 103 ms , respectively ) .


No difference in SDLP ( 42.7 0.08 vs. 42.5 0.07 cm ) , number of lane departures ( 7.6 7.7 vs. 7.0 6.8 ) , or auditory reaction time ( 891 98 and 885 89 ms ) was observed in the drive involving the drink-only condition compared to the corresponding baseline drive .


No difference in reaction time to visual stimuli was observed between baseline and experimental drives for any of the trial conditions .


Participants ' subjective ratings indicated that they perceived the texting while driving condition to be the most difficult despite similar magnitudes of impairment observed with the eating while driving condition .


Distracting behaviors such as eating and texting while driving appear to negatively impact driving measures of lane position control and reaction time .


These findings may have direct implications for motorists that engage in these types of distracting behaviors behind the wheel and for the safety of other road users .


Open abdominal aortic aneurysm ( AAA ) repair is followed by a high rate of incisional herniation .


The purpose of this study was to evaluate whether this postoperative complication could be avoided by a prophylactic implantation of a biological mesh .


In a prospective randomized clinical study , patients electively treated by open AAA repair were allocated equally to routine abdominal suture closure or to prophylactic placement of bovine pericardium mesh above the fascia .


The study end points were postoperative complications and incidence of incisional hernia at a 3-year follow up .


Forty patients with a mean age of 74.3 ( SD 5.8 ) years were studied .


All patients had a successful operation and a quite uneventful postoperative course .


The mean operative time in the mesh group was longer compared to the control group ( p < 0.001 ) .


Two patients in the mesh group developed wound seroma postoperatively .


Six patients ( 30 % ) in the control group developed incisional hernia comparing to none in the mesh group .


Cumulative proportion of freedom from incisional hernia was 100 % for mesh group at 3 years and 74.4 % ( SE 9.9 % ) for control group at 2 years ( p < 0.008 ) .


In five patients ( 83 % ) , the incisional hernia was diagnosed by the second postoperative year .


One patient underwent incisional hernia repair .


The bovine pericardium mesh reinforcement of fascia closure in patients undergoing open AAA repair showed effectiveness and low complication rate in prophylaxis from incisional herniation .


It should be considered as an alternative mesh material in selected patients .


The therapeutic arsenal for MRSA infections is limited .


The aim of this study was to assess the non-inferiority of a combination of trimethoprim/sulfamethoxazole plus rifampicin versus linezolid alone for the treatment of MRSA infection .


We conducted a randomized , open-label , single-centre , non-inferiority trial comparing trimethoprim/sulfamethoxazole ( 160 mg/800 mg three times daily ) plus rifampicin ( 600 mg once a day ) versus linezolid ( 600 mg twice a day ) alone in adult patients with various types of MRSA infection .


Patients were allocated 1:1 to either regimen .


The primary outcome was clinical cure at 6 weeks after the end of treatment ( non-inferiority margin 20 % ) assessed by both ITT and PP analyses .


Secondary outcomes included the microbiologically documented persistence of MRSA in clinical cultures , mortality and adverse events .


The study protocol has been registered with ClinicalTrials.gov ( NCT00711854 ) .


Overall , 150 patients were randomized to one of the two treatment arms between January 2009 and December 2013 and were included in the ITT analysis .


Of these 56/75 ( 74.7 % ) in the linezolid group and 59/75 ( 78.7 % ) in the trimethoprim/sulfamethoxazole and rifampicin group experienced clinical success ( risk difference 4 % , 95 % CI -9.7 % to 17.6 % ) .


The results were confirmed by the PP analysis , with 54/66 ( 81.8 % ) cured patients in the linezolid group versus 52/59 ( 88.1 % ) in the trimethoprim/sulfamethoxazole and rifampicin group ( risk difference 6.3 % , 95 % CI -6.8 % to 19.2 % ) .


There were no statistically significant differences between the two groups in any of the secondary outcomes , including microbiologically documented failure .


Four adverse drug reactions attributed to the study medication occurred in the linezolid group versus nine in the trimethoprim/sulfamethoxazole and rifampicin group .


Compared with linezolid , trimethoprim/sulfamethoxazole and rifampicin seems to be non-inferior in the treatment of MRSA infection .


Antiretroviral therapy initiation for HIV-1 infection is associated with 2 % to 6 % loss of bone mineral density ( BMD ) .


To evaluate the effect of vitamin D3 plus calcium supplementation on bone loss associated with antiretroviral therapy initiation .


48-week prospective , randomized , double-blind , placebo-controlled study .


( ClinicalTrials.gov : NCT01403051 ) .


39 AIDS Clinical Trials Group units .


Adults with antiretroviral therapy-naive HIV .


BMD by dual-energy x-ray absorptiometry , 25-hydroxyvitamin D levels , and other laboratory assessments .


165 eligible patients were randomly assigned ( 79 received vitamin D3 plus calcium and 86 received placebo ) .


The study groups were well-balanced at baseline : 90 % were men , 33 % were non-Hispanic black , and the median CD4 count was 0.341 109 cells/L .


At 48 weeks , the percentage of decline in total hip BMD was smaller in the vitamin D3 plus calcium group than in the placebo group : Medians were -1.36 % ( interquartile range [ IQR ] , -3.43 % to 0.50 % ) and -3.22 % ( IQR , -5.56 % to -0.88 % ) , respectively ( P = 0.004 ) .


Similar results were seen at the lumbar spine .


At 48 weeks , 90 % of patients achieved HIV-1 RNA levels less than 50 copies/mL .


Levels of 25-hydroxyvitamin D3 increased with vitamin D3 plus calcium but not with placebo : Median change was 61.2 nmol/L ( IQR , 36.4 to 94.3 ) versus 1.7 nmol/L ( IQR , -13.2 to 10.7 ) ( P < 0.001 ) .


Overall , 103 patients ( 62 % ) reported 1 or more adverse event , with similar distribution between groups ; no cases of hypercalcemia and 1 case of nephrolithiasis were reported in the placebo group .


No international sites were included , and follow-up was only 48 weeks .


Vitamin D3 plus calcium supplementation mitigates the BMD loss seen with initiation of efavirenz/emtricitabine/tenofovir disoproxil fumarate .


This article describes an experiment that was designed to investigate the effects of sleep deprivation on physiological stress responses in healthy adults .


Twenty-six participants , ages 22-49 , completed a 3-night laboratory experiment with randomization to one night of sleep-deprivation or a normal-sleep control condition .


After a night of baseline sleep , 12 participants were sleep deprived and 14 were not .


After the sleep manipulation , each participant completed the Trier Social Stress Test , a task that requires delivering a speech and performing difficult arithmetic in front of a stern , three-person panel .


The stressor was administered from 5:00 p.m.-5 :30 p.m. and saliva samples were collected 20 and 5 min before ( baseline ) and 5 , 20 , and 40 min after the stressor .


Samples were assayed for cortisol ( a biomarker for the HPA axis ) and alpha-amylase ( a putative biomarker for the sympatho-adrenal medullar system ) .


Sleep deprivation was associated with higher cortisol levels at baseline ( p < .0001 ) and an amplified cortisol response to the stressor relative to control participants ( pinteraction = 0.0039 ) .


Alpha-amylase showed a significant main effect of the stressor ( p = .0026 ) , but there was no effect of sleep loss at baseline or in response to the stressor .


Sleep deprivation is associated with both elevated resting cortisol release and with an exaggerated cortisol response to a stressor indicative of elevated HPA axis responses in healthy adults .


Individual differences in the magnitude of this response may represent a risk factor for psychological and physical health consequences associated with heightened cortisol exposure .


Changes in health care delivery create opportunities to improve systems to better meet the needs of low-income families while achieving quality benchmarks .


Families of healthy newborns receiving primary care at a single large urban safety-net hospital participated .


Intervention families were randomly assigned a family specialist who provided support until the 6-month routine health care visit .


The Developmental Understanding and Legal Collaboration for Everyone ( DULCE ) intervention is based on the Strengthening Families approach and incorporated components of the Healthy Steps and Medical-Legal Partnership models .


Medical record reviews determined use of preventive and emergency care .


Surveys conducted at baseline , postintervention ( 6 months ) , and follow-up ( 12 months ) were used to determine hardship and attainment of concrete supports .


Three hundred thirty families participated in the study .


At baseline , 73 % of families reported economic hardships .


Intervention parents had an average of 14 contacts with the family specialist , and 5 hours of total contact time .


Intervention infants were more likely to have completed their 6-month immunization schedule by age 7 months ( 77 % vs 63 % , P < .005 ) and by 8 months ( 88 % vs 77 % , P < .01 ) .


Intervention infants were more likely to have 5 or more routine preventive care visits by age 1 year ( 78 % vs 67 % , P < .01 ) and were less likely to have visited the emergency department by age 6 months ( 37 % vs 49.7 % , P < .03 ) .


The DULCE intervention accelerated access to concrete resources ( P = .029 ) .


Assignment to the Project DULCE intervention led to improvements in preventive health care delivery and utilization and accelerated access to concrete supports among low-income families .


Foot ulcer is the principal cause of hospitalization for patients with diabetes .


Polydeoxyribonucleotide ( PDRN ) , an adenosine A2A receptor agonist , improves wound healing in diabetic mice .


The aim of this study was to evaluate the effect of PDRN on chronic ulcer healing in patients with diabetes .


This randomized , double-blind , placebo-controlled trial , involved two medical centers in Italy .


Patients with diabetes showing hard-to-heal ulcers ( Wagner grade 1 or 2 ) were randomly assigned to receive placebo ( n = 106 ) or PDRN ( n = 110 ) .


The treatments ( PDRN and placebo ) were performed for 8 weeks by intramuscular and perilesional route [ corrected ] .


The primary outcome was complete ulcer healing .


Secondary outcomes were the days needed to complete wound closure and the reepithelialization of wound surface ( as percentage of the original area ) .


After 8 weeks , 91 placebo and 101 PDRN subjects completed the study .


Complete healing was achieved in 18.9 % [ 95 % confidence interval ( CI ) 11.4-26 .3 ] of placebo and in 37.3 % ( 95 % CI 28.2-46 .3 ) of PDRN-treated patients ( P = .0027 ) .


After 8 weeks , PDRN increased the closure of foot ulcers in diabetic subjects ( hazard ratio 2.20 ; 95 % CI 1.29-3 .75 ; P = .004 ) .


The median time to complete wound healing was 49 days for placebo ( range 28-56 d ) and 30 days for PDRN-treated subjects ( range 14-56 d ; P = .0027 ) .


The median epithelialized area of the ulcers ( expressed as percentage ) was 49.3 % in the placebo and 82.2 % in the PDRN group ( P < .001 ) .


PDRN facilitates the healing of Wagner 1 or 2 diabetic foot ulcers .


Although recent studies have identified the presence of phenotypic clusters in asthmatic patients , the clinical significance and temporal stability of these clusters have not been explored .


Our aim was to examine the clinical relevance and temporal stability of phenotypic clusters in children with asthma .


We applied spectral clustering to clinical data from 1041 children with asthma participating in the Childhood Asthma Management Program .


Posttreatment randomization follow-up data collected over 48 months were used to determine the effect of these clusters on pulmonary function and treatment response to inhaled anti-inflammatory medication .


We found 5 reproducible patient clusters that could be differentiated on the basis of 3 groups of features : atopic burden , degree of airway obstruction , and history of exacerbation .


Cluster grouping predicted long-term asthma control , as measured by the need for oral prednisone ( P < .0001 ) or additional controller medications ( P = .001 ) , as well as longitudinal differences in pulmonary function ( P < .0001 ) .


We also found that the 2 clusters with the highest rates of exacerbation had different responses to inhaled corticosteroids when compared with the other clusters .


One cluster demonstrated a positive response to both budesonide ( P = .02 ) and nedocromil ( P = .01 ) compared with placebo , whereas the other cluster demonstrated minimal responses to both budesonide ( P = .12 ) and nedocromil ( P = .56 ) compared with placebo .


Phenotypic clustering can be used to identify longitudinally consistent and clinically relevant patient subgroups , with implications for targeted therapeutic strategies and clinical trials design .


There is growing interest in clinical screening for pediatric social determinants of health , but little evidence on formats that maximize disclosure rates on a wide range of potentially sensitive topics .


We designed a study to examine disclosure rates and hypothesized that there would be no difference in disclosure rates on face-to-face versus electronic screening formats for items other than highly sensitive items .


We conducted a randomized trial of electronic versus face-to-face social screening formats in a pediatric emergency department .


Consenting English-speaking and Spanish-speaking adult caregivers familiar with the presenting child 's household were randomized to social screening via tablet computer ( with option for audio assist ) versus a face-to-face interview conducted by a fully bilingual/bicultural researcher .


Almost all caregivers ( 96.8 % ) reported at least 1 social need , but rates of reporting on the more sensitive issues ( household violence and substance abuse ) were significantly higher in electronic format , and disclosure was marginally higher in electronic format for financial insecurity and neighborhood and school safety .


There was a significant difference in the proportion of social needs items with higher endorsement in the computer-based group ( 70 % ) than the face-to-face group ( 30 % ) .


Pediatric clinical sites interested in incorporating caregiver-reported socioeconomic , environmental , and behavioral needs screening should consider electronic screening when feasible , particularly when assessing sensitive topics such as child safety and household member substance use .


Cardiovascular disease risk increases when lipoprotein metabolism is dysfunctional .


We have developed a computational model able to derive indicators of lipoprotein production , lipolysis , and uptake processes from a single lipoprotein profile measurement .


This is the first study to investigate whether lipoprotein metabolism indicators can improve cardiovascular risk prediction and therapy management .


We calculated lipoprotein metabolism indicators for 1981 subjects ( 145 cases , 1836 controls ) from the Framingham Heart Study offspring cohort in which NMR lipoprotein profiles were measured .


We applied a statistical learning algorithm using a support vector machine to select conventional risk factors and lipoprotein metabolism indicators that contributed to predicting risk for general cardiovascular disease .


Risk prediction was quantified by the change in the Area-Under-the-ROC-Curve ( AUC ) and by risk reclassification ( Net Reclassification Improvement ( NRI ) and Integrated Discrimination Improvement ( IDI ) ) .


Two VLDL lipoprotein metabolism indicators ( VLDLE and VLDLH ) improved cardiovascular risk prediction .


We added these indicators to a multivariate model with the best performing conventional risk markers .


Our method significantly improved both CVD prediction and risk reclassification .


Two calculated VLDL metabolism indicators significantly improved cardiovascular risk prediction .


These indicators may help to reduce prescription of unnecessary cholesterol-lowering medication , reducing costs and possible side-effects .


For clinical application , further validation is required .


The objective of this study was to determine the feasibility and effectiveness of working memory ( WM ) training in college students with ADHD or learning disabilities ( LD ) .


A total of 62 students ( 21 males , 41 females ) were randomized to a 5-week intensive WM training program or a wait-list control group .


Participants were evaluated before treatment , 3 weeks after completion , and at 2-month follow-up .


The criterion measures were standardized tests of auditory-verbal and visual-spatial WM. Near transfer measures included other cognitive tasks ; far transfer measures included academic tasks and behavioral rating scales .


Intent-to-treat analysis revealed that participants receiving WM training showed significantly greater improvements on the criterion WM measures and self-reported fewer ADHD symptoms and cognitive failures .


The follow-up assessment indicated that gains in WM were maintained , as were improvements in cognitive failures .


Computerized WM training is a feasible and possibly viable approach for enhancing WM in college students with ADHD or LD .


Randomized ovarian cancer trials , including ICON7 , have reported improved progression-free survival ( PFS ) when bevacizumab was added to conventional cytotoxic therapy .


The improvement was modest prompting the search for predictive biomarkers for bevacizumab .


Pretreatment training ( n = 91 ) and validation ( n = 114 ) blood samples were provided by ICON7 patients .


Plasma concentrations of 15 angio-associated factors were determined using validated multiplex ELISAs .


Our statistical approach adopted PFS as the primary outcome measure and involved ( i ) searching for biomarkers with prognostic relevance or which related to between-individual variation in bevacizumab effect ; ( ii ) unbiased determination of cutoffs for putative biomarker values ; ( iii ) investigation of biologically meaningfully predictive combinations of putative biomarkers ; and ( iv ) replicating the analysis on candidate biomarkers in the validation dataset .


The combined values of circulating Ang1 ( angiopoietin 1 ) and Tie2 ( Tunica internal endothelial cell kinase 2 ) concentrations predicted improved PFS in bevacizumab-treated patients in the training set .


Using median concentrations as cutoffs , high Ang1/low Tie2 values were associated with significantly improved PFS for bevacizumab-treated patients in both datasets ( median , 23.0 months vs. 16.2 ; P = 0.003 ) for the interaction of Ang1-Tie2 treatment in Cox regression analysis .


The prognostic indices derived from the training set also distinguished high and low probability for progression in the validation set ( P = 0.008 ) , generating similar values for HR ( 0.21 vs. 0.27 ) between treatment and control arms for patients with high Ang1 and low Tie2 values .


The combined values of Ang1 and Tie2 are predictive biomarkers for improved PFS in bevacizumab-treated patients with ovarian cancer .


These findings need to be validated in larger trials due to the limitation of sample size in this study .


This pilot study investigates the efficacy of a probiotic consortium ( Lab4 ) in combination with vitamin C on the prevention of respiratory tract infections in children attending preschool facilities .


In a double-blind , randomised , placebo-controlled pilot study with children aged 3-6 years , 57 received 1.25 10 ( 10 ) colony-forming units of Lactobacillus acidophilus CUL21 ( NCIMB 30156 ) , Lactobacillus acidophilus CUL60 ( NCIMB 30157 ) , Bifidobacterium bifidum CUL20 ( NCIMB 30153 ) and Bifidobacterium animalis subsp .


lactis CUL34 ( NCIMB 30172 ) plus 50mg vitamin C or a placebo daily for 6 months .


Significant reductions in the incidence rate of upper respiratory tract infection ( URTI ; 33 % , P = 0.002 ) , the number of days with URTI symptoms ( mean difference : -21.0 , 95 % confidence interval ( CI ) : -35.9 , -6.0 , P = 0.006 ) and the incidence rate of absence from preschool ( 30 % , P = 0.007 ) were observed in the active group compared with the placebo .


The number of days of use of antibiotics , painkillers , cough medicine or nasal sprays was lower in the active group and reached significance for use of cough medicine ( mean difference : -6.6 , 95 % CI : -12.9 , -0.3 , P = 0.040 ) .


No significant differences were observed in the incidence rate ratio or duration of lower respiratory tract infection or in the levels of plasma cytokines , salivary immunoglobulin A or urinary metabolites .


Supplementation with a probiotic/vitamin C combination may be beneficial in the prevention and management of URTIs .


Targeting a single pathway in pancreatic adenocarcinoma ( PC ) is unlikely to affect its natural history .


We tested the hypothesis that simulataneous targeting of the epidermal growth factor receptor ( EGFR ) and insulin-like growth factor receptor-1 ( IGF-1R ) pathways would significantly improve progression-free survival ( PFS ) by abrogating reciprocal signaling that promote drug resistance


This was a phase Ib/II study testing cixutumumab , combined with erlotinib and gemcitabine ( G ) in patients with untreated metastatic PC .


The control arm was erlotinib plus G.


The primary end point was PFS .


Eligibility included performance status 0/1 and normal fasting blood glucose .


Polymorphisms in genes involved in G metabolism and in the EGFR pathway were also studied


The phase I results ( n = 10 ) established the safety of cixutumumab 6 mg/kg/week intravenously , erlotinib 100 mg/day orally , and G 1000 mg/m ( 2 ) intravenously on days 1 , 8 , and 15 of a 28-day cycle .


In the RP2 portion ( 116 eligible patients ; median age , 63 ) , the median PFS and overall survival ( OS ) were 3.6 and 7.0 months , respectively , on the cixutumumab arm , and 3.6 and 6.7 months , respecively , on the control arm .


Major grades 3 and 4 toxicities with cixutumumab and control were elevation of transaminases , 12 % and 6 % , respectively ; fatigue , 16 % and 12 % , respectively ; gastrointestinal , 35 % and 28 % , respectively ; neutropenia , 21 % and 10 % , respectively ; and thrombocytopenia , 16 % and 7 % , respecively .


Grade 3/4 hyperglycemia was seen in 16 % of patients on cixutumumab .


Grade 3 or 4 skin toxicity was similar in both arms of the study ( < 5 % ) .


No significant differences in PFS by genotype were seen for any of the polymorphisms .


Adding the IGF-1R inhibitor cixutumumab to erlotinib and G did not lead to longer PFS or OS in metastatic PC .


Conflicting evidence exists regarding the association between saturated fatty acids ( SFAs ) and type 2 diabetes .


In this longitudinal case-cohort study , we aimed to investigate the prospective associations between objectively measured individual plasma phospholipid SFAs and incident type 2 diabetes in EPIC-InterAct participants .


The EPIC-InterAct case-cohort study includes 12,403 people with incident type 2 diabetes and a representative subcohort of 16,154 individuals who were selected from a cohort of 340.234 European participants with 399 million person-years of follow-up ( the EPIC study ) .


Incident type 2 diabetes was ascertained until Dec 31 , 2007 , by a review of several sources of evidence .


Gas chromatography was used to measure the distribution of fatty acids in plasma phospholipids ( mol % ) ; samples from people with type 2 diabetes and subcohort participants were processed in a random order by centre , and laboratory staff were masked to participant characteristics .


We estimated country-specific hazard ratios ( HRs ) for associations per SD of each SFA with incident type 2 diabetes using Prentice-weighted Cox regression , which is weighted for case-cohort sampling , and pooled our findings using random-effects meta-analysis .


SFAs accounted for 46 % of total plasma phospholipid fatty acids .


In adjusted analyses , different individual SFAs were associated with incident type 2 diabetes in opposing directions .


Even-chain SFAs that were measured ( 14:0 [ myristic acid ] , 16:0 [ palmitic acid ] , and 18:0 [ stearic acid ] ) were positively associated with incident type 2 diabetes ( HR [ 95 % CI ] per SD difference : myristic acid 115 [ 95 % CI 109-122 ] , palmitic acid 126 [ 115-137 ] , and stearic acid 106 [ 100-113 ] ) .


By contrast , measured odd-chain SFAs ( 15:0 [ pentadecanoic acid ] and 17:0 [ heptadecanoic acid ] ) were inversely associated with incident type 2 diabetes ( HR [ 95 % CI ] per 1 SD difference : 079 [ 073-085 ] for pentadecanoic acid and 067 [ 063-071 ] for heptadecanoic acid ) , as were measured longer-chain SFAs ( 20:0 [ arachidic acid ] , 22:0 [ behenic acid ] , 23:0 [ tricosanoic acid ] , and 24:0 [ lignoceric acid ] ) , with HRs ranging from 072 to 081 ( 95 % CIs ranging between 061 and 092 ) .


Our findings were robust to a range of sensitivity analyses .


Different individual plasma phospholipid SFAs were associated with incident type 2 diabetes in opposite directions , which suggests that SFAs are not homogeneous in their effects .


Our findings emphasise the importance of the recognition of subtypes of these fatty acids .


An improved understanding of differences in sources of individual SFAs from dietary intake versus endogenous metabolism is needed .


EU FP6 programme , Medical Research Council Epidemiology Unit , Medical Research Council Human Nutrition Research , and Cambridge Lipidomics Biomarker Research Initiative .


Association studies have suggested that lower circulating 25-hydroxyvitamin D [ 25 ( OH ) D ] in African Americans may partially underlie higher rates of cardiovascular disease and cancer in this population .


Nonetheless , the relation between vitamin D supplementation and 25 ( OH ) D concentrations in African Americans remains undefined .


Our primary objective was to determine the dose-response relation between vitamin D and plasma 25 ( OH ) D.


A total of 328 African Americans in Boston , MA , were enrolled over 3 winters from 2007 to 2010 and randomly assigned to receive a placebo or 1000 , 2000 , or 4000 IU vitamin D/d for 3 mo. .


Subjects completed sociodemographic and dietary questionnaires , and plasma samples were drawn at baseline and 3 and 6 mo. .


Median plasma 25 ( OH ) D concentrations at baseline were 15.1 , 16.2 , 13.9 , and 15.7 ng/mL for subjects randomly assigned to receive the placebo or 1000 , 2000 , or 4000 IU/d , respectively ( P = 0.63 ) .


The median plasma 25 ( OH ) D concentration at 3 mo differed significantly between supplementation arms at 13.7 , 29.7 , 34.8 , and 45.9 ng/mL , respectively ( P < 0.001 ) .


An estimated 1640 IU vitamin D/d was needed to raise the plasma 25 ( OH ) D concentration to 20 ng/mL in 97.5 % of participants , whereas a dose of 4000 IU/d was needed to achieve concentrations 33 ng/mL in 80 % of subjects .


No significant hypercalcemia was seen in a subset of participants .


Within African Americans , an estimated 1640 IU vitamin D/d was required to achieve concentrations of plasma 25 ( OH ) D recommended by the Institute of Medicine , whereas 4000 IU/d was needed to reach concentrations predicted to reduce cancer and cardiovascular disease risk in prospective observational studies .


These results may be helpful for informing future trials of disease prevention .


The purpose of this study was to assess the effect of high intensity interval training ( HIIT ) versus continuous aerobic exercise training ( CONT ) or placebo ( PLA ) on body composition by randomized controlled design .


Work capacity and body composition ( dual-energy X-ray absorptiometry ) were measured before and after 12 weeks of intervention in 38 previously inactive overweight adults .


There was a significant group time interaction for change in work capacity ( P < 0.001 ) , which increased significantly in CONT ( 23.8 3.0 % ) and HIIT ( 22.3 3.5 % ) but not PLA ( 3.1 5.0 % ) .


There was a near-significant main effect for percentage trunk fat , with trunk fat reducing in CONT by 3.1 1.6 % and in PLA by 1.1 0.4 % , but not in HIIT ( increase of 0.7 1.0 % ) ( P = 0.07 ) .


There was a significant reduction in android fat percentage in CONT ( 2.7 1.3 % ) and PLA ( 1.4 0.8 % ) but not HIIT ( increase of 0.8 0.7 % ) ( P = 0.04 ) .


These data suggest that HIIT may be advocated as a time-efficient strategy for eliciting comparable fitness benefits to traditional continuous exercise in inactive , overweight adults .


However , in this population HIIT does not confer the same benefit to body fat levels as continuous exercise training .


To evaluate feasibility , acceptability , continuation , and trough serum levels following self-administration of subcutaneous ( sc ) depot medroxyprogesterone acetate ( DMPA ) .


Women presenting to a family planning clinic to initiate , restart or continue DMPA were offered study entry .


Participants were randomized in a 2:1 ratio to self - or clinician administered sc DMPA 104 mg .


Those randomized to self-administration were taught to self-inject and were supervised in performing the initial injection ; they received printed instructions and a supply of contraceptive injections for home use .


Participants randomized to clinician administration received usual care .


Continued DMPA use was assessed by self-report and trough medroxyprogesterone acetate levels at 6 and 12 months .


Two hundred fifty women were invited to participate , and 137 ( 55 % ) enrolled .


Of these , 91 were allocated to self-administration , and 90/91 were able to correctly self-administer sc DMPA .


Eighty-seven percent completed follow-up .


DMPA use at 1 year was 71 % for the self-administration group and 63 % for the clinic group ( p = 0.47 ) .


Uninterrupted DMPA use was 47 % and 48 % for the self and clinic administration groups at 1 year ( p = 0.70 ) , respectively .


Serum analyses confirmed similar mean DMPA levels in both groups and therapeutic trough levels in all participants .


Sixty-three percent of women approached were interested in trying self-administration of DMPA , even in the context of a randomized trial , and nearly all eligible for enrollment were successful at doing so .


Self-administration and clinic administration resulted in similar continuation rates and similar DMPA serum levels .


Self-administration of sc DMPA is feasible and may be an attractive alternative for many women .


Self-administration of sc DMPA is a feasible and attractive option for many women .


Benefits include increased control over contraceptive measures and less time spent on contracepting behaviors .


Globally , self-administration has the potential to revolutionize contraceptive uptake by increasing the number of women with access to DMPA .


Heavy drinking smokers ( HDS ) have more difficulty quitting smoking than lighter drinkers or abstainers .


The opioid antagonist naltrexone may improve smoking quit rates and reduce alcohol use in drinker-smokers , but its relative efficacy in smokers with a range of drinking patterns is unknown .


The current study tested the hypothesis that HDS would show differential benefit of naltrexone versus placebo relative to moderate-to-light or nondrinking smokers in terms of improving smoking outcomes and reducing alcohol consumption .


Adult smokers ( N = 315 ) enrolled in a 12-week , double-blinded , placebo-controlled trial of 50mg naltrexone for smoking cessation were categorized into subgroups based upon past 6-month drinking patterns : HDS ( n = 69 ; i.e. , averaged 2 heavy drinking episodes per month ) , moderate-to-light drinking smokers ( n = 204 , i.e. , consumed 1 drink up to a maximum of < 2 heavy drinking episodes per month on average ) , or nondrinking smokers ( n = 42 , no alcohol consumed in the past 6months ) .


The groups were compared on the main study outcomes of biochemically verified prolonged abstinence quit rates ( i.e. , no smoking weeks 2 to 12 ) , and smoking urge and alcohol use ( drinks/wk ) during treatment .


Naltrexone significantly increased 12-week smoking abstinence rates and decreased smoking urge and alcohol use among HDS , but not moderate-to-light or nondrinking smokers .


Mediation analyses in HDS revealed that naltrexone 's effect on smoking urge during the first 4weeks of treatment mediated its effect on quit rates .


HDS appear to be particularly sensitive to naltrexone effects on smoking and drinking outcomes .


This group may represent an important target for adjunctive treatment with naltrexone to optimize smoking cessation outcomes .


To examine the association between health status , diabetes-specific quality of life ( QoL ) and glycaemic control among individuals with type 2 diabetes .


1876 individuals with screen-detected diabetes and a mean age of 66 years underwent assessment of self-reported health status ( SF-36 ) , diabetes-specific QoL ( the Audit of Diabetes Dependent Quality of Life ( ADDQoL19 ) ) and glycated haemoglobin ( HbA1c ) at five years post-diagnosis in the ADDITION-Europe trial .


Multivariable linear regression was used to quantify the cross-sectional association between health status , diabetes-specific QoL and HbA1c , adjusting for age , sex , education , alcohol consumption , physical activity , BMI , intake of any glucose-lowering drugs , and trial arm .


The mean ( SD ) SF-36 physical and mental health summary scores were 46.2 ( 10.4 ) and 54.6 ( 8.6 ) , respectively .


The median average weighted impact ADDQoL score was -0.32 ( IQR -0.89 to -0.06 ) , indicating an overall negative impact of diabetes on QoL .


Individuals who reported a negative impact of diabetes on their QoL had higher HbA1c levels at five years after diagnosis compared with those who reported a positive or no impact of diabetes ( b-coefficient [ 95 % CI ] : b = 0.2 [ 0.1 , 0.3 ] ) .


Physical and mental health summary SF-36 scores were not significantly associated with HbA1c in multivariable analysis .


Diabetes-specific QoL but not health status was independently associated with HbA1c .


Practitioners should take account of the complex relationship between diabetes-specific QoL and glucose , particularly with regard to dietary behaviour .


Future research should attempt to elucidate via which pathways this association might act .


This study aims to preliminarily evaluate effect on physical properties of shoulder joints and cognitive function after practicing Rue-si-dad-ton , a Thai traditional exercise using the postures of the hermit doing body contortion which still lacks systematically conducted evidence-based regarding its benefits .


Thirty-seven participants who have routinely worked on computer at least 3 hours per day were recruited and randomized into intervention ( n = 19 ) or control group ( n = 18 ) .


Physical effect on shoulder joints was evaluated by measuring shoulder range of motion ( ROM ) and evaluating shoulder function with the American Shoulder & Elbow Surgeons Standardized Shoulder Assessment Form .


Cognitive function was determined by Verbal Fluency Test , Trail Maker B Test , and Digit Span Test .


Both study groups were assessed by all tests at the beginning and at the end of study by blinded assessors .


The intervention group performed 3 postures of Rue-si-dad-ton exercise ( an hour per day for 4 days by a well-trained instructor ) before thefinal measurement .


Only left and right shoulder flexion of the intervention group ( p-value = 0.006 and 0.010 respectively ) showed significant increment compared with the control group using ANCOVA test with baseline adjusted as covariate .


Other variables , including joint and cognitive function , indicated no significant changes between groups .


No complications from exercise were found during the study


Rue-si-dad-ton may safely help improve range of joint motion with potential benefit for joint and cognitive function .


Additional extensive studies with adequate number of participants and longer period of exercise are warranted .


Recruiting participants to multicentre , community-based trials is a challenge .


This case study describes how this challenge was met for the BeWEL trial , which evaluated the impact of a diet and physical activity intervention on body weight in people who had had pre-cancerous bowel polyps .


The BeWEL trial was a community-based trial , involving centres linked to the Scottish National Health Service ( NHS ) colorectal cancer screening programme .


BeWEL had a recruitment target of 316 and its primary recruitment route was the colonoscopy clinics of the Scottish Bowel Screening Programme .


BeWEL exceeded its recruitment target but needed a 6-month no-cost extension from the funder to achieve this .


The major causes of delay were lower consent rates ( 49 % as opposed to 70 % estimated from earlier work ) , the time taken for NHS research and development department approvals and the inclusion of two additional sites to increase recruitment , for which there were substantial bureaucratic delays .


A range of specific interventions to increase recruitment , for example , telephone reminders and a shorter participant information leaflet , helped to increase the proportion of eligible individuals consenting and being randomized .


Recruitment to multicentre trials is a challenge but can be successfully achieved with a committed team .


In a UK context , NHS research and development approval can be a substantial source of delay .


Investigators should be cautious when estimating consent rates .


If consent rates are less than expected , qualitative analysis might be beneficial , to try and identify the reason .


Finally , investigators should select trial sites on the basis of a formal assessment of a site 's past performance and the likelihood of success in the trial being planned .


Current Controlled Trials ISRCTN53033856 .


To evaluate safety and haematological effects of delayed cord clamping ( DCC ) in infants with expected low birthweight born in a resource-poor setting .


Randomised controlled trial involving pregnant women in early labour 18 years with intrapartum symphysal-fundal height 32 cm .


Mothers were randomised for either early cord clamping ( ECC , < 30 s ) or DCC ( 2-3 min after birth ) .


We included 104 vigorous infants born by vaginal delivery , of whom 39 % had a birthweight < 2500 g. Infant haemoglobin ( Hb ) levels 24 h after birth were significantly higher in the DCC group ( 18.0 g/dl vs. 16.8 g/dl , P = 0.006 ) .


Despite successful placental transfusion , hyperbilirubinemia and hyperviscosity were not observed .


Two months after birth , there were no differences in Hb between groups ( 9.9 g/dl vs. 9.8 g/dl , P = 0.60 ) , but the infants in the DCC group had better weight gain from baseline than those with ECC ( 2.2 kg vs. 1.9 kg , P = 0.058 ) .


In this South African cohort of newborns with a subnormal distribution of birthweight delayed cord clamping was a safe procedure .


Two months after birth the effect of DCC on Hb was not detectable anymore .


DCC should be promoted in every singleton delivery in a resource-poor setting irrespective of the birthweight .


Sleep disorders are common among patients hospitalized in coronary care unit ( CCU ) .


This study aimed to investigate the effect of Rosa damascene aromatherapy on sleep quality of patients hospitalized in CCU .


In this randomized controlled trial , 60 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups .


Patients in the control group received routine care .


In the experimental group , patients received routine care and Rosa damascene aromatherapy for three subsequent nights .


In the both groups the sleep quality was assessed using the Pittsburgh Sleep Quality Index .


After the study , the mean scores of five domains of Pittsburg Sleep Quality Index as well as the mean of total score of the index in the experimental group were significantly lower than the control group .


Rosa damascene aromatherapy can significantly improve the sleep quality of patients hospitalized in CCUs .


We evaluated whether self-monitoring of blood glucose ( SMBG ) leads to better glycaemic control ( HbA ( 1c ) ) in patients with type 2 diabetes on conventional insulin regimens .


Patients with type 2 diabetes on a conventional insulin regimen ( basal or premixed insulin with or without additional oral glucose-lowering agents ) were recruited at study centres led by members of the German Diabetes Association .


In a randomised , prospective , open 22 factorial design , the once-weekly performance of four-point glucose profiles ( SMBG + ; n = 151 patients ) was compared with no SMBG ( SMBG - ; n = 149 ) , and the measuring and transmitting of HbA1c results to the study centres ( HbA ( 1c ) + ; n = 158 , of these 82 SMBG - and 76 SMBG + ) was compared with HbA1c measurement without disclosure of results ( HbA ( 1c ) - ; n = 142 , of these 67 SMBG - and 75 SMBG + ) .


Randomised allocation was carried out by a central office , using sequentially numbered , sealed envelopes .


The primary endpoint was the reduction of HbA ( 1c ) compared with baseline after 12 months .


Secondary analyses were of therapy intensification in response to higher blood or urinary glucose or HbA ( 1c ) .


Participants and caregivers were not blinded as to the allocation of interventions , whereas the laboratory determining HbA ( 1c ) remained blinded .


Patient characteristics were balanced across groups .


A total of 56 patients dropped out .


In completers , HbA ( 1c ) was reduced in the SMBG + group from 7.3 % to 7.0 % , i.e. by 0.3 % ( 0.1 % , 0.5 % ) vs SMBG - from 7.3 % to 7.0 % and 0.3 % ( 0.2 % , 0.5 % ) , respectively , the difference being 0.0 % ( -0.2 % , 0.2 % ) ( p = 0.93 ) .


The disclosure of HbA ( 1c ) results had no significant influence , with a difference of 0.1 % ( -0.1 % , 0.4 % ) ( p = 0.28 ) .


Values above are mean ( 95 % CI ) .


The ORs for therapy intensification significantly rose as the following increased : proportions of urine samples testing positive for glucose , HbA1c concentrations , and fasting or postprandial glucose concentrations .


No important adverse events were associated with the interventions .


SMBG profiles once weekly or the disclosure of HbA ( 1c ) results did not improve glycaemic control in patients with type 2 diabetes on conventional insulin treatment , although indicators of hyperglycaemia increased the likelihood of therapy intensification .


Greater intensification may be necessary to impact on glycaemic control .


www.clinicaltrials.gov ( registration code NCT00688363 ) FUNDING : Deutsche Diabetes-Gesellschaft , Deutsche Diabetes-Stiftung , Bayer Vital GmbH .


Three anatomical sites are commonly used to insert central venous catheters , but insertion at each site has the potential for major complications .


In this multicenter trial , we randomly assigned nontunneled central venous catheterization in patients in the adult intensive care unit ( ICU ) to the subclavian , jugular , or femoral vein ( in a 1:1:1 ratio if all three insertion sites were suitable [ three-choice scheme ] and in a 1:1 ratio if two sites were suitable [ two-choice scheme ] ) .


The primary outcome measure was a composite of catheter-related bloodstream infection and symptomatic deep-vein thrombosis .


A total of 3471 catheters were inserted in 3027 patients .


In the three-choice comparison , there were 8 , 20 , and 22 primary outcome events in the subclavian , jugular , and femoral groups , respectively ( 1.5 , 3.6 , and 4.6 per 1000 catheter-days ; P = 0.02 ) .


In pairwise comparisons , the risk of the primary outcome was significantly higher in the femoral group than in the subclavian group ( hazard ratio , 3.5 ; 95 % confidence interval [ CI ] , 1.5 to 7.8 ; P = 0.003 ) and in the jugular group than in the subclavian group ( hazard ratio , 2.1 ; 95 % CI , 1.0 to 4.3 ; P = 0.04 ) , whereas the risk in the femoral group was similar to that in the jugular group ( hazard ratio , 1.3 ; 95 % CI , 0.8 to 2.1 ; P = 0.30 ) .


In the three-choice comparison , pneumothorax requiring chest-tube insertion occurred in association with 13 ( 1.5 % ) of the subclavian-vein insertions and 4 ( 0.5 % ) of the jugular-vein insertions .


In this trial , subclavian-vein catheterization was associated with a lower risk of bloodstream infection and symptomatic thrombosis and a higher risk of pneumothorax than jugular-vein or femoral-vein catheterization .


( Funded by the Hospital Program for Clinical Research , French Ministry of Health ; ClinicalTrials.gov number , NCT01479153 . )


This research used context aware experiential sampling to investigate the effect of contexts on in vivo alcohol-related outcome expectancies .


A time-stratified random sampling strategy was adopted to assess 72 students and young professionals at 5 daily intervals over the course of a week using a specifically designed smartphone application .


This application recorded respondents ' present situational and social contexts , alcohol consumption , and alcohol-related cognitions in real-time .


In vivo social and environmental contexts and current alcohol consumption accounted for a significant proportion of variance in outcome expectancies .


For instance , prompts which occurred while participants were situated in a pub , bar , or club and in a social group of friends were associated with heightened outcome expectancies in comparison with other settings .


Alcohol-related expectancies do not appear to be static but instead demonstrate variation across social and environmental contexts .


Modern technology can be usefully employed to provide a more ecologically valid means of measuring such beliefs .


Intramedullary techniques for stabilization of displaced distal radius fractures are now available .


Purported benefits include limited soft tissue dissection while affording sufficient stability to allow early wrist motion .


The primary null hypothesis of this randomized trial is that there is no significant difference with respect to functional outcome , pain and disability between patients treated with either 2.4-mm volar locking plate fixation or intramedullary nail fixation of unstable dorsally displaced extra-articular fractures of the distal radius .


We conducted a single-centre , parallel-group trial , with unrestricted randomization .


Patients with dorsally displaced extra-articular distal radius fractures were randomized to receive volar locking plate ( n = 72 ) fixation or intramedullary nailing ( n = 80 ) .


The outcome was measured on the basis of the Gartland and Werley and Castaing score ; the pain level ; the range of wrist motion ; the rate of complications ; and radiographic measurements including volar tilt and ulnar variance .


Clinical and radiographic assessment was performed at 8 weeks , 6 months , 1 year and 2 years after the operation .


There were no significant differences between groups in terms of range of motion , grip strength or the level of pain during the entire follow-up period ( p > 0.05 ) .


There was no significant difference between treatment groups with respect to volar tilt or ulnar variance ( p > 0.05 ) .


There was no significant difference in the complication rate between groups ( p > 0.05 ) .


The present study supports the view that intramedullary nail fixation and volar plate fixation for the treatment of displaced extra-articular distal radius fractures have equivalent radiographic and functional outcomes .


Level I therapeutic study .


Emergence hypertension after craniotomy is a well-documented phenomenon for which natural history is poorly understood .


Most clinicians attribute this phenomenon to an acute and transient increase in catecholamine release , but other mechanisms such as neurogenic hypertension or activation of the renin-angiotensin-aldosterone system have also been proposed .


In this open-label study , we compared the monotherapeutic antihypertensive efficacy of the 2 most titratable drugs used to treat postcraniotomy emergence hypertension : nicardipine and esmolol .


We also investigated the effect of preoperative hypertension on postcraniotomy hypertension and the natural history of postcraniotomy hypertension in the early postoperative period .


Fifty-two subjects were prospectively randomized to receive either nicardipine or esmolol as the sole drug for treatment of emergence hypertension at the conclusion of brain tumor resection ( 40 subjects finally analyzed ) .


After a uniform anesthetic , standardized protocols of these antihypertensive medications were administered for the treatment of systolic blood pressure ( SBP ) > 130 , with the goal of maintaining SBP < 140 throughout the first postoperative day .


In the event of study medication `` failure , '' a `` rescue '' antihypertensive ( labetalol or hydralazine ) was used .


The O'Brien-Fleming Spending Function was used to calculate the appropriate value for each interim analysis of the primary outcome ; univariate analysis was performed otherwise , with a 2-sided P < 0.05 considered statistically significant .


The incidence of nicardipine failure ( 5 % , 95 % confidence interval [ CI ] 0.1 % -24.9 % ) was significantly less than that of esmolol ( 55 % , 95 % CI 31.5 % -76.9 % ) as a sole drug in controlling SBP after brain tumor resection ( difference 99 % CI 13.8 % -75.7 % , P = 0.0012 ) .


The presence of preoperative hypertension or the approach to surgery ( open craniotomy versus endonasal transsphenoidal ) had no significant effect on the incidence of failure of the antihypertensive regimen used .


We did not observe a difference in the need for opioid therapy for postcraniotomy pain between drug groups ( 99 % CI difference -39.2 % -30.2 % ) .


Failure of the study drug predicted the need for rescue drug therapy in the initial 12 hours after discharge from the recovery room ( difference success versus failure = -41.7 % , 99 % CI difference -72.3 % to -1.8 % , P = 0.0336 ) but not during the period 12 to 24 hours after discharge from the recovery room ( difference success versus failure = -27.4 % , 99 % CI difference -63.8 % -9.2 % , P = 0.143 ) .


However , in those patients carrying a preoperative diagnosis of hypertension , the need for rescue medication was only different during the period 12 to 24 hours after discharge from the recovery room ( difference normotensive versus hypertensive = -35.4 % , 99 % CI difference -66.9 % to -0.3 % , P = 0.0254 ) .


Nicardipine is superior to esmolol for the treatment of postcraniotomy emergence hypertension .


This type of hypertension is thought to be a transient phenomenon not solely related to sympathetic activation and catecholamine surge but also possibly encompassing other physiologic factors .


For treating postcraniotomy emergence hypertension , nicardipine is a relatively effective sole drug , whereas if esmolol is used , rescue antihypertensive medications should be readily available .


To investigate whether a fixed-dose combination ( FDC ) of 0.5 mg dutasteride and 0.4 mg tamsulosin is more effective than watchful waiting with protocol-defined initiation of tamsulosin therapy if symptoms did not improve ( WW-All ) in treatment-nave men with moderately symptomatic benign prostatic hyperplasia ( BPH ) at risk of progression .


This was a multicentre , randomised , open-label , parallel-group study ( NCT01294592 ) in 742 men with an International Prostate Symptom Score ( IPSS ) of 8-19 , prostate volume 30mL and total serum PSA level of 1.5 ng/mL .


Patients were randomised to FDC ( 369 patients ) or WW-All ( 373 ) and followed for 24 months .


All patients were given lifestyle advice .


The primary endpoint was symptomatic improvement from baseline to 24 months , measured by the IPSS .


Secondary outcomes included BPH clinical progression , impact on quality of life ( QoL ) , and safety .


The change in IPSS at 24 months was significantly greater for FDC than WW-All ( -5.4 vs -3.6 points , P < 0.001 ) .


With FDC , the risk of BPH progression was reduced by 43.1 % ( P < 0.001 ) ; 29 % and 18 % of men in the WW-All and FDC groups had clinical progression , respectively , comprising symptomatic progression in most patients .


Improvements in QoL ( BPH Impact Index and question 8 of the IPSS ) were seen in both groups but were significantly greater with FDC ( P < 0.001 ) .


The safety profile of FDC was consistent with established profiles of dutasteride and tamsulosin .


FDC therapy with dutasteride and tamsulosin , plus lifestyle advice , resulted in rapid and sustained improvements in men with moderate BPH symptoms at risk of progression with significantly greater symptom and QoL improvements and a significantly reduced risk of BPH progression compared with WW plus initiation of tamsulosin as per protocol .


Dynamic hip screw ( DHS ) is recommended for the fixation of stable intertrochanteric fractures .


Its postoperative cut-out rate ranges from 1 % to 6 % .


In osteoporotic bone , normal screws in DHS blade provide less anchorage compared to locking screws .


This study aims to compare DHS with locking side plate and conventional side plate .


Fifty consecutive patients with intertrochanteric fractures were randomly allocated for fixation with a standard DHS ( group A ) and locking DHS ( Combi plate , group B ) .


We compared the clinical and radiological outcomes for the conventional DHS and locking DHS in intertrochanteric fractures .


Functional outcome was evaluated using the Parker mobility score .


Coxa valga was found more frequently in group A than in group B ( 12 % vs. 0 % , P = 0.42 ) .


Coxa vara showed the same trend ( 12 % vs. 8 % , P = 0.81 ) .


Rate of restoration of postoperative neck-shaft angle within 20 of sound side was higher in group B ( 8 % cases ) than in group A ( 4 % cases , P = 0.98 ) .


The rate of anteversion angle restoration within 10 of sound side was also higher in group B ( 100 % vs. 88 % , P = 0.85 ) .


The average lag screw slippage in group A and group B was 3.2 mm and 4.2 mm , the average fracture union duration was 17.1 weeks and 16.4 weeks , and the mean Parker score was 5.6 and 5.8 respectively .


Screw cut-out was seen in one patient in group A. No cut-out was seen in any of the patient in group B. No patient developed deep infection , avascular necrosis , deep vein thrombosis or any other significant complications .


The present study demonstrated that treating intertrochanteric fracture with a locking DHS allows sound bone healing and is not associated with any major complications .


Although this report is promising , it should be interpreted with caution because only a prospective study with a large sample size would allow definitive conclusion .


Studies evaluating the effect of folic acid supplementation , either alone or in combination with iron , on the linear and ponderal growth of children are practically nonexistent .


The aim of this study was to assess the effect of folic acid supplementation with ferrous sulfate on both linear growth and weight gain in anemic and nonanemic children attending Municipal Daycare Centers in Goiania , State of Goias , Brazil .


A double-blind , randomized , controlled trial was conducted on 188 children aged 6-24 months .


The effects of ferrous sulfate and folic acid supplementation were evaluated using the analysis of variance procedure , based on a double factorial model with two factors of fixed effects ( folic acid supplementation and ferrous sulfate supplementation ) , adjusted for initial weight .


The level of significance was 0.05 .


The children who received folic acid supplementation showed greater weight gain than the monthly average weight gain of those not given the supplement ( P = 0.026 ) .


This effect was independent of the dose of ferrous sulfate ( P for interaction = 0.693 ) .


Folic acid supplementation increased the gain of weight-for-age Z-score when compared with the placebo group ( P = 0.018 ) , independent of the dose of ferrous sulfate .


Folic acid had no effect on linear growth .


The use of folic acid supplementation increased the monthly average weight gain and the gain in weight-for-age Z-score compared with the placebo group .


This effect was independent of the dose of ferrous sulfate .


To determine if differing gauge ( G ) needles used for venipuncture altered the automated platelet count and coagulation profile ( prothrombin time ( PT ) and activated partial thromboplastin time ( aPTT ) ) in clinically healthy dogs .


Prospective , observational , randomised , clinical study .


We enrolled 20 clinically healthy dogs .


Blood was collected via direct venipuncture of the jugular veins with 21G , 23G and 25G needles in a random order .


Automated haematology and automated coagulation times were performed on the blood samples .


Values were analysed for differences among the needle gauges and also the order of sample collection .


No difference was found in the automated platelet count or automated coagulation times for the three needle gauges used or the order in which the samples were collected .


Venipuncture can be performed with a 21G , 23G or 25G needle to obtain blood from dogs for automated platelet count and PT/aPTT measurement without affecting the results .


Dried fruits , like their fresh homologues , contain relatively high concentrations of antioxidants .


The aim of this study was to determine the health outcomes of raisin consumption on patients with diabetes .


We examined the effects of dried grapes ( Vitis vinifera ) cultivated in Greece , namely Corinthian Raisins ( CR ) on blood pressure , fasting glucose , glucated hemoglobin ( HbA1c ) , lipid peroxidation , high-sensitivity C-reactive protein , antioxidant status , and cytokines in patients with type 2 diabetes mellitus ( T2DM ) .


Forty-eight well-controlled patients with T2DM from the diabetes outpatient clinic of our hospital were recruited to a two-armed , randomized , controlled , 24-wk prospective intervention trial in order to examine the health outcomes of CR consumption .


All participants were reported to consume less fruits and vegetables than the recommended amount of five servings daily .


Participants in the intervention were instructed to consume CR equal to two fruit servings ( 36 g/d ) , replacing snacks with similar energy density twice during the day .


Anthropometric and blood pressure measurements , assessment of dietary intake , and fasting blood draws were conducted at baseline and at week 24 .


Also , phenolic compounds present in CR were analyzed in plasma of the patients .


t Test for parametric data and Mann-Whitney test or Wilcoxon test for non-parametric data were performed .


Significance was set at P < 0.05 .


Body weight , glycemic control , and lipid profile were not affected in either arm .


Patients in the CR arm reduced their diastolic blood pressure and increased their total antioxidant potential significantly compared with baseline .


The differences between the two groups at week 24 were significant .


No change in high-sensitivity C-reactive protein was observed .


A significant difference in plasma circulating p-hydroxybenzoic acid was observed between groups at the end of the trial .


Our study shows that naturally CR may improve health features in patients with well-controlled T2DM .


The use of low-dose aspirin ( LDA ) has emerged as an important cause of gastrointestinal ulcers .


The aim of this study was to investigate the association between LDA-induced gastric mucosal injury and the expression of vascular endothelial growth factor ( VEGF ) and cell apoptosis in elderly Chinese patients .


A total of 136 patients aged 60 to 80 years with LDA-induced ( 100 mg/d for at least 1 month ) gastric mucosal injury and 48 age-matched healthy subjects were enrolled in this study .


The patients were divided into a low-severity group and a high-severity group based on their modified Lanza scale scores .


Biopsy specimens of gastric mucosa from all participants were subjected to immunohistochemical staining for VEGF expression and terminal deoxynucleotidyl transferase dUTP nick end labeling staining for cell apoptosis .


Staining indices and apoptotic indices were applied to assess VEGF expression level and the extent of cell apoptosis .


VEGF expression decreased significantly in the 2 patient groups , whereas the extent of cell apoptosis significantly increased compared with the control group .


Furthermore , Spearman 's correlation coefficients suggest that VEGF expression levels and the extent of cell apoptosis in gastric mucosae shared a significant correlation with the severity of LDA-induced gastric mucosal injury .


Receiver operating characteristics analysis further confirmed these results .


Our findings provide important clues as to the underlying molecular mechanism behind gastric mucosal injury resulting from exposure to LDA in elderly adults , and also suggest that interventions specifically targeting the pathways associated with angiogenesis and apoptosis may help facilitate the healing process .


Despite the improvement in the care management , women cancer patients who are still in employment find themselves for the most part obliged to stop working while they are having treatment .


Their return-to-work probability is impacted by numerous psychosocial factors .


The objective is to describe the development and the content of an intervention aimed to facilitate the return to work of female breast cancer patients and in particular the women in the most precarious situations through early active individualised psychosocial support ( APAPI ) .


The intervention proposed is made up of 4 interviews with a psychologist at the hospital , distributed over the year according to the diagnosis and conducted on the same day as a conventional follow-up consultation , then a consultation with a specialist job retention physician .


We expect , in the first instance , that this intervention will reduce the social inequalities of the return-to-work rate at 12 months .


The EPICES score will enable the population to be broken down according to the level of social precariousness .


The other expected results are the reduction of the social inequalities in the quality of the return to work at 18 and 24 months and the disparities between the individual and collective resources of the patients .


This intervention is assessed in the context of a controlled and randomised multi-centre study .


The patients eligible are women aged between 18 and 55 years with a unilateral breast cancer with local extension exclusively , having received surgery followed by adjuvant chemotherapy , in employment at the time of the diagnosis and dealt with by one of the 2 investigating centres .


It is essential to assess this type of intervention before envisaging its generalisation .


The study set in place will enable us to measure the impact of this intervention aiming to facilitate the return to work of breast cancer patients , in particular for those who suffer from social fragility , compared with the standard care .


Infant HIV-1 infection is associated with impaired neurologic and motor development .


Antiretroviral therapy ( ART ) has the potential to improve developmental outcomes but the relative contributions of pre-ART disease status , growth , treatment regimen and ART response during infancy are unknown .


Kenyan ART-naive infants < 5-months old initiated ART and had monthly assessment of age of full neck control , unsupported walking and monosyllabic speech during 24 months of follow-up .


Pre-ART and post-ART correlates of age at milestone attainment were evaluated using t tests or multivariate linear regression .


Among 99 infants , pre-ART correlates of later milestone attainment included : underweight and stunted ( neck control , walking and speech , all P values < 0.05 ) , missed prevention of mother-to-child transmission ( P = 0.04 ) ( neck control ) , previous hospitalization , World Health Organization ( WHO ) Stage III/IV , low CD4 count , and wasting ( speech and walking , all P values < 0.05 ) , and low maternal CD4 ( speech , P = 0.04 ) .


Infants initiated ART at a median of 14 days following enrollment .


Infants receiving lopinavir/ritonavir-based versus nevirapine-based ART attained later speech ( 18.1 vs. 15.5 months , P = 0.003 ) .


Adjusting for pre-ART level , lower 6-month gain in CD4 % was associated with later walking ( 0.18 months earlier per unit increase in CD4 % ; P = 0.004 ) and speech ( 0.12 months earlier per unit increase in CD4 % ; P = 0.05 ) , and lower 6-month gains in weight-for-age ( P = 0.009 ) , height-for-age ( P = 0.03 ) and weight-for-height ( P = 0.02 ) were associated with later walking .


In HIV-infected infants , compromised pre-ART immune and growth status , poor post-ART immune and growth responses , and use of lopinavir/ritonavir-based versus nevirapine-based ART were each associated with later milestone attainment .


The long-term consequences of these delays are unknown .


To determine whether symptoms and clinical signs of swallowing dysfunction could be easily identified in community-dwelling elderly adults and to examine the association between self-report and direct observation of symptoms and signs of swallowing dysfunction .


Physiological substudy conducted as a home visit within an observational cohort study .


Baltimore City and County , Maryland .


Community-dwelling elderly women without history of dysphagia or neurological disease aged 85 to 94 enrolled in the Women 's Health and Aging Study II ( N = 47 ) .


Three trials of the 3-ounce water swallowing test , swallowing function questionnaire , and frailty status .


Thirty-four ( 72 % ) subjects demonstrated swallowing dysfunction in at least one swallowing trial and 16 ( 34 % ) in all three trials .


The most common signs of dysfunction were throat clear and wet voice .


Conversely , participants reported few symptoms of dysphagia on a swallowing function questionnaire .


The most common symptom , reported by approximately 15 % of participants , was the sensation of the food going `` down the wrong way , '' 8.5 % or fewer participants reported other symptoms .


Signs of swallowing dysfunction were present in a large majority of community-dwelling old-old women , but they were largely unrecognized and reported .


Formal evaluation of swallowing function in community-dwelling elderly adults is necessary to determine the clinical consequences of these findings .


To assess the ability of various fluoride salts to protect enamel against acid attack via a barrier mechanism .


Extracted human enamel specimens were cleaned and rinsed , then soaked in pooled human saliva for 1 hour to initiate formation of an early pellicle .


Groups of three specimens each were etched for 10 minutes in 1 % citric acid ( pH 2.3 ) , treated in a 1:3 slurry of dentifrice [ 1,100 ppm F as stannous fluoride ( SnF2 ) , 1,100 ppm F as sodium fluoride ( NaF ) , 1,000 ppm F as sodium monofluorophosphate ( SMFP ) , or 1,400 ppm F as amine fluoride ( AmF ) ] and saliva for 2 minutes , exposed to 2 % alizarin red-S ( a calcium-selective dye ) and rinsed again .


The relative ability of each test product to deposit a barrier layer on the enamel surface was measured by its ability to protect against attachment of the calcium-selective dye .


Specimens treated with the SnF2 dentifrice showed the least dye attachment , indicating a high level of surface protection .


On a five-point scale , with 0 being no dye deposition ( 100 % protection ) and four being complete dye coverage ( 0 % protection ) , the SnF2 - treated specimens scored an average of 0.25 , with NaF scoring 3.4 , SMFP scoring 3.4 and AmF scoring 3.7 .


Protection of the enamel surface was significantly higher for the SnF2 product than for the other products ( P < 0.05 ) , with no significant differences among the other three F salts .


These results demonstrate that after an aggressive acid challenge , SnF2 deposits a barrier layer onto the pellicle-coated enamel surface , and the barrier layer which attaches onto acid challenged tooth surfaces is different from any that might be provided by treatment with the other fluoride compounds tested .


To assess the effectiveness , feasibility , and safety of short-term inspiratory and expiratory muscle training ( IEMT ) in subacute stroke patients .


Within 2 weeks of stroke onset , 109 patients with a first ischemic stroke event were randomly assigned to the IEMT ( n = 56 ) or sham IEMT ( n = 53 ) study group .


The IEMT consisted of 5 sets of 10 repetitions , twice a day , 5 days per week for 3 weeks , at a training workload equivalent to 30 % of maximal respiratory pressures .


Patients and researchers assessing outcome variables were blinded to the assigned study group .


The main outcome was respiratory muscle strength assessed by maximal inspiratory and expiratory pressures ( PImax , PEmax ) .


Respiratory complications at 6 months were also recorded .


Both groups improved respiratory muscle strength during the study .


IEMT was associated with significantly improved % PImax and % PEmax : effect size d = 0.74 ( 95 % confidence interval [ CI ] 0.28-1 .20 ) and d = 0.56 ( 95 % CI 0.11-1 .02 ) , respectively .


No significant training effect was observed for peripheral muscle strength .


Respiratory complications at 6 months occurred more frequently in the sham group ( 8 vs 2 , p = 0.042 ) , with an absolute risk reduction of 14 % .


The number needed to treat to prevent one lung infection event over a follow-up of 6 months was 7 .


No major adverse events or side effects were observed .


IEMT induces significant improvement in inspiratory and expiratory muscle strength and could potentially offer an additional therapeutic tool aimed to reduce respiratory complications at 6 months in stroke patients .


This study provides Class II evidence that short-term training may have the potential to improve respiratory muscle strength in patients with subacute stroke .


Unstuck and On Target ( UOT ) is an executive function ( EF ) intervention for children with autism spectrum disorders ( ASD ) targeting insistence on sameness , flexibility , goal-setting , and planning through a cognitive-behavioral program of self-regulatory scripts , guided/faded practice , and visual/verbal cueing .


UOT is contextually-based because it is implemented in school and at home , the contexts in which a child uses EF skills .


To evaluate the effectiveness of UOT compared with a social skills intervention ( SS ) , 3rd-5th graders with ASD ( mean IQ = 108 ; UOT n = 47 ; SS n = 20 ) received interventions delivered by school staff in small group sessions .


Students were matched for gender , age , race , IQ , ASD symptomotolgy , medication status , and parents ' education .


Interventions were matched for ` dose ' of intervention and training .


Measures of pre-post change included classroom observations , parent/teacher report , and direct child measures of problem-solving , EF , and social skills .


Schools were randomized and evaluators , but not parents or teachers , were blinded to intervention type .


Interventions were administered with high fidelity .


Children in both groups improved with intervention , but mean change scores from pre - to postintervention indicated significantly greater improvements for UOT than SS groups in : problem-solving , flexibility , and planning/organizing .


Also , classroom observations revealed that participants in UOT made greater improvements than SS participants in their ability to follow rules , make transitions , and be flexible .


Children in both groups made equivalent improvements in social skills .


These data support the effectiveness of the first contextually-based EF intervention for children with ASD .


UOT improved classroom behavior , flexibility , and problem-solving in children with ASD .


Individuals with variable background/training in ASD successfully implemented UOT in mainstream educational settings .


The use of insulin-sensitizing drugs has been shown to improve both the reproductive and the metabolic aspects of PCOS .


However , the mechanisms by which metformin exerts its effects in PCOS are still not completely understood .


There is growing evidence of a direct effect of metformin on ovarian steroidogenesis , independent of its effects on insulin sensitivity .


We evaluated the short-term effects of metformin compared to placebo on basal and LH - stimulated androgen secretion as well as on hormonal and metabolic parameters in 19 women with PCOS during a four-day randomized , double-blinded placebo-controlled clinical trial .


In a three month follow-up evaluation , we investigated the longer-term therapeutic effects of metformin on ovulation , metabolic and endocrine parameters .


Compared to placebo , 2days of metformin was associated with a borderline significant reduction in the free androgen index ( FAI ) ( p = 0.05 ) and with a reduction in the serum concentration of LH-stimulated testosterone ( T ) ( p = 0.03 ) .


Following three months of use , a decline in serum T was observed , independent of changes in weight , metabolic parameters , or insulin sensitivity .


In women with PCOS , Metformin induces a prompt decrease in LH-stimulated T secretion after only several days of use .


This action precedes the medication 's effects on insulin sensitivity or weight loss .


We examined the association between Helicobacter pylori infection and the immune response following oral immunization of US adults with attenuated Salmonella Typhi vaccine CVD 908-htrA .


Baseline sera from 74 volunteers without a history of typhoid fever who were immunized orally with CVD 908-htrA were tested by enzyme-linked immunosorbent assay for immunoglobin G ( IgG ) antibodies to H. pylori , hepatitis A antibodies ( a marker of low socioeconomic status and exposure to enteric infections ) , and pepsinogen ( PG ) I and II levels ( measures of gastric inflammation ) .


IgG against S. Typhi lipopolysaccharide ( LPS ) O and flagella was measured before and 28 days following immunization ; a 4-fold increase in titer from baseline constituted seroconversion .


Seroconversion of S. Typhi IgG LPS antibodies was significantly higher among vaccinees infected with H. pylori versus uninfected subjects : adjusted odds ratio ( OR ) 3.8 , 95 % confidence interval ( CI ) , 1.1-12 .6 ( P = .03 ) .


A low PG I : PG II ratio ( < 5 ) , indicating more advanced corpus gastritis , increased the odds of seroconversion of IgG S. Typhi flagella antibody ( adjusted OR 6.4 , 95 % CI , 1.3-31 .4 ; P = .02 ) .


Hepatitis A infection did not influence the immune response to CVD 908-htrA .


H. pylori infection and gastric inflammation may enhance humoral immunity to oral attenuated S. Typhi vaccine .


Given minority patients ' unequal access to quality care , patient activation and self-management strategies have been suggested as a promising approach to improving mental health care .


To determine whether the DECIDE ( Decide the problem ; Explore the questions ; Closed or open-ended questions ; Identify the who , why , or how of the problem ; Direct questions to your health care professional ; Enjoy a shared solution ) intervention , an educational strategy that teaches patients to ask questions and make collaborative decisions with their health care professional , improves patient activation and self-management , as well as engagement and retention in behavioral health care .


In this multisite randomized clinical trial performed from February 1 , 2009 , through October 9 , 2011 ( date of last follow-up interview ) , we recruited 647 English - or Spanish-speaking patients 18 to 70 years old from 13 outpatient community mental health clinics across 5 states and 1 US territory .


A total of 722 patients were included in analyses of secondary outcomes .


Three DECIDE training sessions delivered by a care manager vs giving patients a brochure on management of behavioral health .


Primary outcomes were patient assessment of activation ( Patient Activation Scale ) and self-management ( Perceived Efficacy in Patient-Physician Interactions ) .


Secondary outcomes included patient engagement ( proportion of visits attended of those scheduled ) and retention ( attending at least 4 visits in the 6 months after the baseline research assessment ) , collected through medical record review or electronic records .


Patients assigned to DECIDE reported significant increases in activation ( mean = 1.74 , SD = 0.58 ; P = .003 ) and self-management ( mean = 2.42 , SD = 0.90 ; P = .008 ) relative to control patients , but there was no evidence of an effect on engagement or retention in care .


The DECIDE intervention appears to help patients learn to effectively ask questions and participate in decisions about their behavioral health care , but a health care professional component might be needed to augment engagement in care .


DECIDE appears to have promise as a strategy for changing the role of minority patients in behavioral health care .


clinicaltrials.gov Identifier : NCT01226329


The promotion of well-being is an important goal of recovery oriented mental health services .


No structured , evidence-based intervention exists that aims to increase the well-being in people with severe mental illness such as psychosis .


Positive psychotherapy ( PPT ) is a promising intervention for this goal .


Standard PPT was adapted for use with people with psychosis in the UK following the Medical Research Council framework for developing and testing complex interventions , resulting in the WELLFOCUS Model describing the intended impact of WELLFOCUS PPT .


This study aims to test the WELLFOCUS Model , by piloting the intervention , trial processes , and evaluation strategy .


This study is a non-blinded pragmatic pilot RCT comparing WELLFOCUS PPT provided as an 11-session group therapy in addition to treatment as usual to treatment as usual alone .


Inclusion criteria are adults ( aged 18-65 years ) with a main diagnosis of psychosis who use mental health services .


A target sample of 80 service users with psychosis are recruited from mental health services across the South London and Maudsley NHS Foundation Trust .


Participants are randomised in blocks to the intervention and control group .


WELLFOCUS PPT is provided to groups by specifically trained and supervised local therapists and members of the research team .


Assessments are conducted before randomisation and after the group intervention .


The primary outcome measure is well-being assessed by the Warwick-Edinburgh Mental Well-being Scale .


Secondary outcomes include good feelings , symptom relief , connectedness , hope , self-worth , empowerment , and meaning .


Process evaluation using data collected during the group intervention , post-intervention individual interviews and focus groups with participants , and interviews with trial therapists will complement quantitative outcome data .


This study will provide data on the feasibility of the intervention and identify necessary adaptations .


It will allow optimisation of trial processes and inform the evaluation strategy , including sample size calculation , for a future definitive RCT .


Current Controlled Trials ISRCTN04199273 - WELLFOCUS study : an intervention to improve well-being in people with psychosis , Date registered : 27 March 2013 , first participant randomised on 26 April 2013 .


To examine how different response scales , methods of survey administration , and survey format affect responses to the CAHPS ( Consumer Assessment of Healthcare Providers and Systems ) Clinician and Group ( CG-CAHPS ) survey .


A total of 6,500 patients from a university health center were randomly assigned to receive the following : standard 12-page mail surveys using 4-category or 6-category response scales ( on CG-CAHPS composite items ) , telephone surveys using 4-category or 6-category response scales , or four-page mail surveys .


A total of 3,538 patients completed surveys .


Composite score means and provider-level reliabilities did not differ between respondents receiving 4-category or 6-category response scale surveys or between 12-page and four-page mail surveys .


Telephone respondents gave more positive responses than mail respondents .


We recommend using 4-category response scales and the four-page mail CG-CAHPS survey .


Postpartum hemorrhage ( PPH ) is a leading cause of maternal death in sub-Saharan Africa .


Although the World Health Organization recommends use of oxytocin for prevention of PPH , misoprostol use is increasingly common owing to advantages in shelf life and potential for sublingual administration .


There is a lack of data about the comparative efficacy of oxytocin and sublingual misoprostol , particularly at the recommended dose of 600 g , for prevention of PPH during active management of labor .


We performed a double-blind , double-dummy randomized controlled non-inferiority trial between 23 September 2012 and 9 September 2013 at Mbarara Regional Referral Hospital in Uganda .


We randomized 1,140 women to receive 600 g of misoprostol sublingually or 10 IU of oxytocin intramuscularly , along with matching placebos for the treatment they did not receive .


Our primary outcome of interest was PPH , defined as measured blood loss 500 ml within 24 h of delivery .


Secondary outcomes included measured blood loss 1,000 ml ; mean measured blood loss at 1 , 2 , and 24 h after delivery ; death ; requirement for blood transfusion ; hemoglobin changes ; and use of additional uterotonics .


At 24 h postpartum , primary PPH occurred in 163 ( 28.6 % ) participants in the misoprostol group and 99 ( 17.4 % ) participants in the oxytocin group ( relative risk [ RR ] 1.64 , 95 % CI 1.32 to 2.05 , p < 0.001 ; absolute risk difference 11.2 % , 95 % CI 6.44 to 16.1 ) .


Severe PPH occurred in 20 ( 3.6 % ) and 15 ( 2.7 % ) participants in the misoprostol and oxytocin groups , respectively ( RR 1.33 , 95 % CI 0.69 to 2.58 , p = 0.391 ; absolute risk difference 0.9 % , 95 % CI -1.12 to 2.88 ) .


Mean measured blood loss was 341.5 ml ( standard deviation [ SD ] 206.2 ) and 304.2 ml ( SD 190.8 , p = 0.002 ) at 2 h and 484.7 ml ( SD 213.3 ) and 432.8 ml ( SD 203.5 , p < 0.001 ) at 24 h in the misoprostol and oxytocin groups , respectively .


There were no significant differences between the two groups in any other secondary outcomes .


Women in the misoprostol group more commonly experienced shivering ( RR 1.91 , 95 % CI 1.65 to 2.21 , p < 0.001 ) and fevers ( RR 5.20 , 95 % CI 3.15 to 7.21 , p = 0.005 ) .


This study was conducted at a regional referral hospital with capacity for emergency surgery and blood transfusion .


High-risk women were excluded from participation .


Misoprostol 600 g is inferior to oxytocin 10 IU for prevention of primary PPH in active management of labor .


These data support use of oxytocin in settings where it is available .


While not powered to do so , the study found no significant differences in rate of severe PPH , need for blood transfusion , postpartum hemoglobin , change in hemoglobin , or use of additional uterotonics between study groups .


Further research should focus on clarifying whether and in which sub-populations use of oxytocin would be preferred over sublingual misoprostol .


ClinicalTrials.gov NCT01866241 Please see later in the article for the Editors ' Summary .


Despite current standard of care , many patients at high risk of cardiovascular disease ( CVD ) still have elevated low-density lipoprotein cholesterol ( LDL-C ) levels .


Alirocumab is a fully human monoclonal antibody inhibitor of proprotein convertase subtilisin/kexin type 9 .


The objective of the study was to compare the LDL-C-lowering efficacy of adding alirocumab vs other common lipid-lowering strategies .


Patients ( n = 355 ) with very high CVD risk and LDL-C levels of 70 mg/dL or greater or high CVD risk and LDL-C of 100 mg/dL or greater on baseline atorvastatin 20 or 40 mg were randomized to one of the following : 1 ) add-on alirocumab 75 mg every 2 weeks ( Q2W ) sc ; 2 ) add-on ezetimibe 10 mg/d ; 3 ) double atorvastatin dose ; or 4 ) for atorvastatin 40 mg regimen only , switch to rosuvastatin 40 mg .


For patients not achieving protocol-defined LDL-C goals , the alirocumab dose was increased ( blinded ) at week 12 to 150 mg Q2W .


The primary end point was percentage change in calculated LDL-C from baseline to 24 weeks ( intent to treat ) .


Among atorvastatin 20 and 40 mg regimens , respectively , add-on alirocumab reduced LDL-C levels by 44.1 % and 54.0 % ( P < .001 vs all comparators ) ; add-on ezetimibe , 20.5 % and 22.6 % ; doubling of atorvastatin dose , 5.0 % and 4.8 % ; and switching atorvastatin 40 mg to rosuvastatin 40 mg , 21.4 % .


Most alirocumab-treated patients ( 87.2 % and 84.6 % ) achieved their LDL-C goals .


Most alirocumab-treated patients ( 86 % ) maintained their 75-mg Q2W regimen .


Treatment-emergent adverse events occurred in 65.4 % of alirocumab patients vs 64.4 % ezetimibe and 63.8 % double atorvastatin/switch to rosuvastatin ( data were pooled ) .


Adding alirocumab to atorvastatin provided significantly greater LDL-C reductions vs adding ezetimibe , doubling atorvastatin dose , or switching to rosuvastatin and enabled greater LDL-C goal achievement .


Prevention of tick borne diseases in forestry workers is essentially based on the use of appropriate clothing .


The objective of this pragmatic , randomized , controlled trial was to assess the potential benefit of permethrin-treated working trousers for the prevention of tick infestation during forestry work .


N = 164 male forestry workers were equipped for a period of 16 weeks with permethrin-treated ( intervention group-I ) or untreated work trousers ( control group-II ) .


Subgroups , according to the use of trousers with ( I-1 , II-1 ) or without cut protection lining ( I-2 , II-2 ) were constituted .


Tick infestation ( quantity of ticks on the body surface ) was assessed by questionnaire after 16 workdays .


Control and intervention groups were compared by calculating the infestation rate ( percentage of subjects with ticks ) and the average number of ticks per workday .


The infestation rate in the intervention group was significantly lower than in the control group ( 36.6 vs. 63.4 % , p = 0.001 ; Fisher-test ) .


Further analysis revealed a significant reduction of tick infestation by permethrin treatment only for subjects wearing trousers without the cut protection lining ( I-2 : 34.2 vs. II-2 : 80.0 % , p < 0.001 ) , while users of cut protection trousers did not benefit from such treated trousers ( I-1 : 38.6 vs. II-1 : 47.6 % , n.s. ) .


Similar results were found for comparisons based on the average number of ticks per workday .


The use of permethrin-treated trousers does not completely prevent tick infestations .


Improvement of tick protection has been shown only for some applications , but not in general .


Additional prevention measures are therefore still indispensable .


Clinical infection remains a significant problem in implant-based breast reconstruction and is a physical and emotional strain to the breast reconstruction patient .


Bacterial strikethrough of draping and gown material is a likely source of infection .


Strategies to reduce infection in implant-based breast reconstruction are essential to improve patient outcomes .


The aim of this study is to determine if a disposable draping system is superior to reusable draping materials in the prevention of implant-based breast reconstruction infection .


This single-institution , prospective , randomized , single-blinded , IRB-approved study enrolled women with breast cancer who were eligible for implant-based breast reconstruction .


The primary endpoint was clinical infection by postoperative day 30 .


Secondary endpoints included all other complications encountered throughout the follow-up period and culture data .


Demographic data recorded included patient age , body mass index , diabetes , smoking , chemotherapy , radiation , and follow-up .


Procedural data recorded included procedure type , procedure length , estimated blood loss , use of acellular dermal matrix , use of muscle flap , and inpatient versus outpatient setting .


From March 2010 through January 2012 , 107 women were randomized and 102 completed the study .


Five patients were determined not to be candidates for reconstruction after randomization .


There were 43 patients in the Reusable Group and 59 patients in the Disposable Group .


There were no significant differences in patient demographic data , procedural data , or the type of procedure performed between groups .


In the Reusable Group , there were 5 infections ( 12 % ) within 30 days compared to 0 ( 0 % ) infections in the Disposable Group ( P = 0.012 ) .


There was no significant difference in secondary complications .


There was a trend for positive wound cultures ( 11 % vs. 3 % , P = 0.10 ) and positive drape cultures ( 17 % vs. 4 % , P = 0.08 ) in patients with clinical infection .


There were no differences in the number of colony-forming units or positive cultures between groups .


Disposable draping material is superior to a reusable draping system in the prevention of clinical infection within the immediate postoperative period .


This study did not demonstrate a clear link between intraoperative culture data and the development of clinical infection .


A completely disposable gown and draping system is recommended during implant-based breast reconstruction .


Drawbacks exist with the standard treatment ( four-layer compression bandages ) for venous leg ulcers .


We have therefore compared the clinical effectiveness and cost-effectiveness of two-layer compression hosiery with the four-layer bandage for the treatment of such ulcers .


We undertook this pragmatic , open , randomised controlled trial with two parallel groups in 34 centres in England and Northern Ireland .


The centres were community nurse teams or services , family doctor practices , leg ulcer clinics , tissue viability clinics or services , and wound clinics .


Participants were aged 18 years or older with a venous leg ulcer and an ankle brachial pressure index of at least 08 , and were tolerant of high compression .


We randomly allocated participants ( 1:1 ) to receive two-layer compression hosiery or a four-layer bandage , using a remote randomisation service and prevalidated computer randomisation program .


Participants were stratified by ulcer duration and ulcer area with permuted blocks ( block sizes four and six ) .


The primary endpoint was time to ulcer healing , with a maximum follow-up of 12 months .


Although participants and health-care providers were not masked to treatment allocation , the primary endpoint was measured by masked assessment of photographs .


Primary analysis was intention to treat with Cox regression , with adjustment for ulcer area , ulcer duration , physical mobility , and centre .


This trial is registered with the ISRCTN register , number ISRCTN49373072 .


We randomly allocated 457 participants to the two treatment groups : 230 to two-layer hosiery and 227 to the four-layer bandage , of whom 453 ( 230 hosiery and 223 bandage ) contributed data for analysis .


Median time to ulcer healing was 99 days ( 95 % CI 84-126 ) in the hosiery group and 98 days ( 85-112 ) in the bandage group , and the proportion of ulcers healing was much the same in the two groups ( 709 % hosiery and 704 % bandage ) .


More hosiery participants changed their allocated treatment ( 383 % hosiery vs 270 % bandage ; p = 002 ) .


300 participants had 895 adverse events , of which 85 ( 95 % ) were classed as serious but unrelated to trial treatment .


Two-layer compression hosiery is a viable alternative to the four-layer bandage-it is equally as effective at healing venous leg ulcers .


However , a higher rate of treatment changes in participants in the hosiery group than in the bandage group suggests that hosiery might not be suitable for all patients .


NIHR Health Technology Assessment programme ( 07/60/26 ) .


Ranolazine reduces the frequency of angina and use of sublingual nitroglycerin ( SL NTG ) in stable angina patients with type 2 diabetes ( T2DM ) .


Because pre-clinical data suggest that myocardial late sodium current ( INaL ) , the target of ranolazine , is increased by hyperglycemia , we investigated whether the efficacy of ranolazine was influenced by glycemic control .


TERISA was a multinational , randomized , double-blind trial of ranolazine vs. placebo in patients with T2DM and stable angina .


Anginal episodes and SL NTG use were recorded daily in an electronic diary .


Health status was evaluated at baseline and 8weeks post-randomization using the Seattle Angina Questionnaire ( SAQ ) .


The interaction between baseline HbA1c and treatment effect was tested across endpoints using analysis of covariance models , with HbA1c as a continuous variable with restricted cubic splines .


The study included 913 patients , with mean age 63.6 years , 39 % women , mean T2DM duration 7.4 years , and mean HbA1c of 7.3 % .


Heterogeneity of efficacy by HbA1c was observed for the primary endpoint of angina frequency ( Pinteraction = .027 ) , the key secondary endpoint of SL NTG use ( Pinteraction = .030 ) , SAQ angina frequency ( Pinteraction = .001 ) , and SAQ treatment satisfaction ( Pinteraction = .025 ) with greater efficacy of ranolazine in those with higher HbA1c values , increasing continuously from HbA1c levels > 6.5 % .


Among patients with T2DM and stable angina , the therapeutic benefits of ranolazine were greater in those with higher HbA1c values .


These data suggest that ranolazine is particularly beneficial in patients with stable angina who have suboptimally controlled T2DM .


To identify patient baseline characteristics that predict recognition acuity at 4.5 years of age in the Infant Aphakia Treatment Study , a study of patients with monocular infantile cataracts .


We analyzed baseline characteristics of the 114 infants enrolled in the Infant Aphakia Treatment Study to determine which were most predictive of visual outcome at 4.5 years of age .


All infants underwent cataract surgery between 1 and 7 months of age .


Monocular acuity was assessed at 4.5 years of age by a traveling examiner using the Amblyopia Treatment Study HOTV protocol .