In the SCD-HeFT ( Sudden Cardiac Death in Heart Failure Trial ) , a pre-specified subgroup analysis showed that patients with New York Heart Association functional class III symptoms did not benefit from implantable cardioverter-defibrillator ( ICD ) therapy and appeared to be harmed by amiodarone , whereas New York Heart Association functional class II patients obtained significant survival benefit from ICD .


We postulated that a more objective measure of functional capacity , such as 6-min walk ( 6MW ) distance , might provide a better tool for selecting these preventive therapies .


A 6MW test was performed before randomization in 2,397 patients .


Median follow-up was 45.5 months .


All-causemortality was the primary endpoint , with cause-specific mortality ( heart failure , arrhythmic ) examined insecondary analyses .


The hazard ratios ( HRs ) for ICD therapy compared to placebo were estimated within tertiles of baseline 6MW distance : HR : 0.42 ( 95 % confidence interval [ CI ] : 0.26 to 0.66 ) for 6MW distance > 386 m ( top tertile ) ; HR : 0.57 ( 95 % CI : 0.39 to 0.83 ) for 6MW distance 288 to 386 m ( middle tertile ) ; and HR : 1.02 ( 95 % CI : 0.75 to 1.39 ) for 6MW distance < 288 m ( bottom tertile ) .


The corresponding HRs for amiodarone compared to placebo were 0.68 ( 95 % CI : 0.46 to 1.02 ) for the top , 0.86 ( 95 % CI : 0.61 to 1.21 ) for the middle , and 1.56 ( 95 % CI : 1.17 to 2.09 ) for the bottom tertile .


The 6MW distance was inversely related to heart failure-related mortality but not to arrhythmic mortality .


ICD therapy reduced arrhythmic mortality in the top 2 tertiles of 6MW , but had no effect on heart failure mortality .


A baseline 6MW distance < 288 m identified a subgroup of SCD-HeFT patients who were harmed by amiodarone therapy and did not benefit from ICD .


( Sudden Cardiac Death in Heart Failure Trial [ SCD-HeFT ] ; NCT00000609 ) .


Pre-diabetes and non-alcoholic fatty liver disease ( NAFLD ) are associated with an unhealthy lifestyle and pose extremely high costs to the healthcare system .


In this study , we aim to explore whether individualized aerobic exercise ( AEx ) and low carbohydrate diet ( LCh ) intervention affect hepatic fat content ( HFC ) in pre-diabetes via modification of gut microbiota composition and other post-interventional effects .


A 6-month randomized intervention with 6-month follow-up is conducted from January 2013 to December 2015 .


The target sample size for intervention is 200 postmenopausal women and middle-aged men aged 50-65year-old with pre-diabetes and NAFLD .


The qualified subjects are randomized into 4 groups with 50 subjects in each group : 1 = AEx , 2 = LCh , 3 = AEx + LCh , and 4 = control .


In addition , two age-matched reference groups ( 5 = pre-diabetes without NAFLD ( n = 50 ) and 6 = Healthy without pre-diabetes or NAFLD ( n = 50 ) ) are included .


The exercise program consists of progressive and variable aerobic exercise ( intensity of 60 to 75 % of initial fitness level , 3-5 times/week and 30-60min / time ) .


The diet program includes dietary consultation plus supplementation with a special lunch meal ( 40 % of total energy intake/day ) which aims to reduce the amount of carbohydrate consumption ( 30 % ) .


The control and reference groups are advised to maintain their habitual habits during the intervention .


The primary outcome measures are HFC , serum metabolomics and gut microbiota composition .


The secondary outcome measures include body composition and cytokines .


In addition , socio-psychological aspects , social support , physical activity and diet will be performed by means of questionnaire and interview .


Specific individualized exercise and diet intervention in this study offers a more efficient approach for liver fat reduction and diabetes prevention via modification of gut microbiota composition .


Besides , the study explores the importance of incorporating fitness assessment and exercise in the management of patients with pre-diabetes and fatty liver disorders .


If our program is shown to be effective , it will open new strategies to combat these chronic diseases .


Current Controlled Trials : ISRCTN42622771 .


Obesity and weight-loss are associated with methylation patterns in specific genes , but their effect on Long Interspersed Nuclear Elements ( LINE-1 ) methylation , a measure of global methylation is largely unknown .


Three hundred overweight/obese post-menopausal women ( 50-75 years ) were part of a completed , 1-year randomized controlled trial , comparing independent and combined effects of a reduced-calorie weight-loss diet , and exercise program , versus control .


DNA was extracted from peripheral blood leukocytes collected at baseline and 12-months , and LINE-1 methylation analyzed by pyrosequencing .


Mean changes between groups using generalized estimating equations and examined effects of weight-loss on LINE-1 methylation using stratified analyses ( gained weight/no weight-loss [ N = 84 ] ; < 5 % [ N = 45 ] ; 5 % -10 % [ N = 45 ] ; > 10 % of baseline weight-loss [ N = 126 ] ) within each arm , adjusted by blood cell counts were compared .


Associations between LINE-1 methylation and previously measured biomarkers , and anthropometrics were also examined .


No significant difference in LINE-1 methylation levels was detected in any intervention group versus controls .


The magnitude of weight-loss was not associated with LINE-1 methylation at 12-months .


There were no associations between baseline characteristics of participants , or previously measured biomarkers , and LINE-1 methylation .


Our results suggest that lifestyle changes sufficient to significantly reduce weight over 12-months may not change LINE-1 DNA methylation levels .


To compare contrast doses and acquisition times for late gadolinium enhancement ( LGE ) imaging at 3.0 T using gadobenate dimeglumine ( Gd-BOPTA ) in patients with chronic myocardial infarction .


Thirty-four patients with chronic myocardial infarction were randomised to 0.10 , 0.15 and 0.20 mmol/kg of Gd-BOPTA .


T1-weighted inversion recovery gradient echo sequences were performed at 5 , 10 , 15 and 20 min post-administration of contrast in a 3.0-T scanner .


Scar-to-myocardium contrast-to-noise ratio ( CNR ) , scar-to-blood CNR , scar size and image quality were assessed .


Imaging at 5 min was associated with a lower scar-to-blood CNR in comparison to 10 , 15 and 20 min at 0.10 mmol/kg , and in comparison to 15 and 20 min at 0.20 mmol/kg .


At 0.10-mmol / kg , imaging at 5 min yielded smaller infarct sizes in comparison to 15 and 20 min .


Finally , at 0.20-mmol / kg , imaging at 5 min was associated with poorer image quality in comparison to later times .


In LGE imaging at 3.0 T , low doses of Gd-BOPTA perform equally well as higher doses .


Early acquisition ( 5 min ) is associated with lower infarct sizes and image quality .


Studies with sufficient diagnostic quality can be obtained after 10 min using 0.10 mmol/kg Gd-BOPTA .


Good performance of low Gd-BOPTA doses for LGE imaging at 3.0 T. Imaging at 5 min yields lower contrast , infarct sizes and image quality .


Diagnostic quality can be obtained after 10 min using 0.10-mmol / kg Gd-BOPTA .


Plant stanol esters lower serum low-density lipoprotein ( LDL ) - cholesterol ( LDL-C ) , but responses between individuals vary widely .


As the ability of subjects to respond to acute dietary challenges may reflect the flexibility to adapt to changes on the longer term , we related subjects ' acute postprandial metabolic changes to changes in serum lipoproteins after chronic intake of plant stanol esters .


In a double-blind crossover design , 20 healthy subjects received in random order a high-fat shake enriched with or without plant stanol esters ( 4 g ) .


Blood samples were taken during 4 h to examine lipid , glucose and lipoprotein profiles .


Two subjects dropped out .


For the 3 weeks after this postprandial test , the subjects who received the shake with plant stanol esters continued the consumption of plant stanol-enriched ( 3g/day ) margarine and subjects receiving the control shake in the postprandial test consumed for the next 3 weeks a control margarine .


After the washout period , subjects received the other shake and margarines .


The margarine enriched with plant stanol esters lowered concentrations of total cholesterol by 7.3 % ( P < 0.01 ) , LDL-C by 9.5 % ( P < 0.01 ) and apoB100 by 8.6 % ( P < 0.01 ) .


Furthermore , particle concentrations of total very low-density lipoprotein ( VLDL ) , small VLDL and large LDL were reduced by 26.6 % ( P = 0.02 ) , 27.6 % ( P = 0.02 ) and 12.3 % ( P = 0.04 ) , respectively .


Plant stanol esters did not affect parameters related to lipid and glucose metabolism during the postprandial phase .


However , the incremental area under the curve ( iAUC ) of the postprandial glucose concentration after consuming the control shake correlated positively with changes in fasting concentrations of total cholesterol , LDL-C , apoB100 , total VLDL , small VLDL and intermediate-density lipoprotein after 3 weeks .


A single dose of plant stanol esters does not change postprandial lipid and lipoprotein profiles .


However , postprandial glucose responses may predict the effects of chronic plant stanol ester consumption .


This study sought to evaluate the diagnostic performance of multiparametric cardiovascular magnetic resonance ( CMR ) for detecting cardiac allograft vasculopathy ( CAV ) using contemporary invasive epicardial artery and microvascular assessment techniques as reference standards , and to compare the performance of CMR with that of angiography .


CAV continues to limit the long-term survival of heart transplant recipients .


Coronary angiography has a Class I recommendation for CAV surveillance and annual or biannual surveillance angiography is performed routinely inmost centers .


All transplant recipients referred for surveillance angiography at a single UK center over a 2-year period were prospectively screened for study eligibility .


Patients prospectively underwent coronary angiography followed by coronary intravascular ultrasound , fractional flow reserve , and index of microcirculatory resistance .


Within 1 month , patients underwent multiparametric CMR , including assessment of regional and global ventricular function , absolute myocardial blood flow quantification , and myocardial tissue characterization .


In addition , 10 healthy volunteers underwent CMR .


Forty-eight patients were recruited , median 7.1 years ( interquartile range : 4.6 to 10.3 years ) since transplantation .


The CMR myocardial perfusion reserve was the only independent predictor of both epicardial ( = -0.57 , p < 0.001 ) and microvascular disease ( = -0.60 , p < 0.001 ) on stepwise multivariable regression .


The CMRmyocardial perfusion reserve significantly outperformed angiography for detecting moderate CAV ( area underthe curve , 0.89 [ 95 % confidence interval ( CI ) : 0.79 to 1.00 ] vs. 0.59 [ 95 % CI : 0.42 to 0.77 ] , p = 0.01 ) and severe CAV ( area under the curve , 0.88 [ 95 % CI : 0.78 to 0.98 ] vs. 0.67 [ 95 % CI : 0.52 to 0.82 ] , p = 0.05 ) .


CAV , including epicardial and microvascular components , can be detected more accurately using noninvasive CMR-based absolute myocardial blood flow assessment than with invasive coronary angiography , the current clinical surveillance technique .


Acute lower respiratory infections ( ALRI ) are a leading cause of death among children .


Low birthweight is prevalent in South Asia and associated with increased risks of mortality , and morbidity , high levels of indoor household air pollution caused by open burning of biomass fuels are common and associated with high rates of ALRI and low birthweight .


Alternative stove designs that burn biomass fuel more efficiently have been proposed as one method for reducing these high exposures and lowering rates of these disorders .


We designed two randomized trials to test this hypothesis .


We conducted a pair of community-based , randomized trials of alternative cookstove installation in a rural district in southern Nepal .


Phase one was a cluster randomized , modified step-wedge design using an alternative biomass stove with a chimney .


A pre-installation period of morbidity assessment and household environmental assessment was conducted for six months in all households .


This was followed by a one year step-wedge phase with 12 monthly steps for clusters of households to receive the alternative stove .


The timing of alternative stove introduction was randomized .


This step-wedge phase was followed in all households by another six month follow-up phase .


Eligibility criteria for phase one included household informed consent , the presence of a married woman of reproductive age ( 15-30 yrs ) or a child < 36 months .


Children were followed until 36 months of age or the end of the trial .


Pregnancies were identified and followed until completion or end of the trial .


Phase two was an individually randomized trial of the same alternative biomass stove versus liquid propane gas stove in a subset of households that participated in phase one .


Follow-up for phase two was 12 months following stove installation .


Eligibility criteria included the same components as phase one except children were only enrolled for morbidity follow-up if they were less than 24 months.The primary outcomes included : incidence of ALRI in children and birthweight .


We presented the design and methods of two randomized trials of alternative cookstoves on rates of ALRI and birthweight .


Clinicaltrials.gov ( NCT00786877 , Nov. 5 , 2008 ) .


Patients with atrial fibrillation ( AF ) are at significantly increased risk of stroke .


Oral anticoagulants ( OACs ) substantially reduce this risk , with gains seen across the spectrum of baseline risk .


Despite the benefit to patients , OAC prescribing remains suboptimal in the United Kingdom ( UK ) .


We will investigate whether an automated software system , operating within primary care electronic medical records , can improve the management of AF by identifying patients eligible for OAC therapy and increasing uptake of this treatment .


We will conduct a cluster randomised controlled trial , involving general practices using the Egton Medical Information Systems ( EMIS ) Web clinical system .


We will randomise practices to use an electronic software tool or to continue with usual care .


The tool will a ) produce ( and continually refresh ) a list of patients with AF who are eligible for OAC therapy -- practices will invite these patients to discuss therapy at the start of the trial -- and b ) generate electronic screen reminders in the medical records of those eligible , appearing throughout the trial .


The software will run for 6 months in 23 intervention practices .


A total of 23 control practices will manage their AF register in line with the usual care offered .


The primary outcome is change in proportion of eligible patients with AF who have been prescribed OAC therapy after six months .


Secondary outcomes are incidence of stroke , transient ischaemic attack , other major thromboembolism , major haemorrhage and reports of inappropriate OAC prescribing in the data collection sample -- those deemed eligible for OACs .


We will conduct a process evaluation in parallel with the randomised trial .


We will use qualitative methods to examine patient and practitioner views of the intervention and its impact on primary care practice , including its time implications .


AURAS-AF will investigate whether a simple intervention , using electronic primary care records , can improve OAC uptake in a high risk group for stroke .


Given previous concerns about safety , especially surrounding inappropriate prescribing , we will also examine whether electronic reminders safely impact care in this clinical area .


http://ISRCTN 55722437 .


The novel isoxazoline molecule fluralaner provides 12weeks activity against fleas and 8 to 12weeks against tick infestations according to label claims .


This blinded , multi-center study in client-owned dogs evaluated the flea control provided by a single oral fluralaner treatment ( 25-56mg / kg ; Bravecto , Merck Animal Health ) compared to a control group administered three oral spinosad ( 30 - 60mg/kg ; Comfortis , Elanco ) treatments at 4-week intervals together with an amitraz collar ( 9 % , Preventic , Virbac ) .


Households were randomized ( 3:1 ratio ) to either fluralaner ( 224 dogs , 118 households ) or control ( 70 dogs , 39 households ) .


Within households , one primary dog with at least 10 live fleas at enrollment was randomly selected for whole body flea counts every 4weeks through Week 12 ; all dogs were followed for safety until Week 12 .


Fluralaner dogs received two additional doses at Weeks 12 and 24 for further safety and palatability observations through Week 26 .


Geometric mean flea count reductions from baseline for the fluralaner group at Weeks 4 , 8 , and 12 were 99.7 % , 99.8 % , and 99.8 % , respectively ; and 96.1 % , 99.5 % , and 99.6 % for the spinosad controls .


Percentages of flea-free primary dogs at Weeks 4 , 8 , and 12 were 91.1 % , 95.4 % , and 95.3 % for the fluralaner group ; and 44.7 % , 88.2 % , and 84.4 % for the controls ; the differences were significant at Weeks 4 ( P < 0.0001 ) and 12 ( P = 0.0370 ) .


Improvements in veterinarian assessed flea allergy dermatitis ( FAD ) were observed in both groups .


Fluralaner tablets were accepted free choice in over 90 % of doses .


The most common adverse event was vomiting , occurring in 7.1 % of the fluralaner group and 14.3 % of the controls .


No treatment related serious adverse events were reported .


A single treatment of dogs with the palatable fluralaner flavored chewable tablet provides a safe and effective option for 12weeks of flea control at least equivalent to that of 3 sequential treatments with spinosad tablets .


Linked to the high level of flea control was a substantial alleviation of associated signs of FAD .


Asparaginase and steroids can cause hypertriglyceridaemia in children with acute lymphoblastic leukaemia ( ALL ) .


There are no guidelines for screening or management of patients with severe hypertriglyceridaemia ( > 1000mg/dL ) during ALL therapy .


Fasting lipid profiles were obtained prospectively at four time-points for 257 children consecutively enrolled on a frontline ALL study .


Risk factors were evaluated by the exact chi-square test .


Details of adverse events and management of hypertriglyceridaemia were extracted retrospectively .


Eighteen of 257 ( 7 % ) patients developed severe hypertriglyceridaemia .


Older age and treatment with higher doses of asparaginase and steroids on the standard/high-risk arm were significant risk factors .


Severe hypertriglyceridaemia was not associated with pancreatitis after adjustment for age and treatment arm or with osteonecrosis after adjustment for age .


However , patients with severe hypertriglyceridaemia had a 2.5-3 times higher risk of thrombosis compared to patients without , albeit the difference was not statistically significant .


Of the 30 episodes of severe hypertriglyceridaemia in 18 patients , seven were managed conservatively while the others with pharmacotherapy .


Seventeen of 18 patients continued to receive asparaginase and steroids .


Triglyceride levels normalised after completion of ALL therapy in all 12 patients with available measurements .


Asparaginase - and steroid-induced transient hypertriglyceridaemia can be adequately managed with dietary modifications and close monitoring without altering chemotherapy .


Patients with severe hypertriglyceridaemia were not at increased risk of adverse events , with a possible exception of thrombosis .


The benefit of pharmacotherapy in decreasing symptoms and potential complications requires further investigation .


We examined electronic cigarette ( EC ) use , correlates of use , and associated changes in smoking behavior among smokers with serious mental illness in a clinical trial .


Adult smokers were recruited during acute psychiatric hospitalization ( N = 956 , 73 % enrollment among approached smokers ) in the San Francisco Bay Area between 2009-2013 .


At baseline , participants averaged 17 ( SD = 10 ) cigarettes per day for 19 ( SD = 14 ) years ; 24 % intended to quit smoking in the next month .


Analyses examined frequency and correlates of EC use reported over the 18-month trial and changes in smoking behavior by EC use status .


EC use was 11 % overall , and by year of enrollment , increased from 0 % in 2009 to 25 % in 2013 .


In multiple logistic regression , the likelihood of EC use was significantly greater with each additional year of recruitment , for those aged 18-26 , and for those in the preparation versus precontemplation stage of change , and unlikely among Hispanic participants .


EC use was unrelated to gender , psychiatric diagnosis , and measures of tobacco dependence at baseline .


Further , over the 18-month trial , EC use was not associated with changes in smoking status or , among continued smokers , with reductions in cigarettes per day .


Within a clinical trial with smokers with serious mental illness , EC use increased over time , particularly among younger adults and those intending to quit tobacco .


EC use was unrelated to changes in smoking .


The findings are of clinical interest and warrant further study .


We hypothesized that showing native Spanish speaking parents , a Spanish video explaining the risks and benefits of anesthesia within two weeks prior to surgery would reduce parental anxiety .


Subjects were randomly assigned to video-group or non-video-group .


Both groups completed PPUS , STAIT and APAIS tests before and after viewing the videos .


Parents repeated the same three tests before the operation on the day of the surgery .


The results revealed a decrease in 3 points on the APAIS assessment in the non-video-group compared to 5.8 points decrease in the video-group .


PPUS assessment revealed an average 1.25 points increase in the non-video-group compared to 11 points decrease in video-group .


Due to the extremely low sample size , the statistical significance of the findings can not be verified by statistical methods .


Hispanic parents who viewed the preanesthesia Spanish-video had lower levels of anxiety compared to those who did not watch the video .


The aim of this study was to examine the influence of aftercare sessions in a psychosomatic rehabilitation on the sociomedical development .


The after care group was compared with treatment as usual .


In a prospective , controlled and randomized longitudinal study data about the state of health and job status were assessed at 4 measured time points .


As an indicator of the sociomedical development the current employment status was used .


Aftercare treatment ( n = 139 ) included 2-4 interview contacts ( via telephone or face-to-face ) within the first 3 months after discharge from inpatient psychosomatic rehabilitation .


A control group ( n = 62 ) received treatment as usual .


3 and 9 months after the end of rehabilitation participants in the aftercare showed a better sociomedical development than the participants in the control condition .


To determine the effectiveness of helmet therapy for positional skull deformation compared with the natural course of the condition in infants aged 5-6 months .


Pragmatic , single blinded , randomised controlled trial ( HEADS , HElmet therapy Assessment in Deformed Skulls ) nested in a prospective cohort study .


29 paediatric physiotherapy practices ; helmet therapy was administered at four specialised centres .


84 infants aged 5 to 6 months with moderate to severe skull deformation , who were born after 36 weeks of gestation and had no muscular torticollis , craniosynostosis , or dysmorphic features .


Participants were randomly assigned to helmet therapy ( n = 42 ) or to natural course of the condition ( n = 42 ) according to a randomisation plan with blocks of eight .


Six months of helmet therapy compared with the natural course of skull deformation .


In both trial arms parents were asked to avoid any ( additional ) treatment for the skull deformation .


The primary outcome was change in skull shape from baseline to 24 months of age assessed using plagiocephalometry ( anthropometric measurement instrument ) .


Change scores for plagiocephaly ( oblique diameter difference index ) and brachycephaly ( cranioproportional index ) were each included in an analysis of covariance , using baseline values as the covariate .


Secondary outcomes were ear deviation , facial asymmetry , occipital lift , and motor development in the infant , quality of life ( infant and parent measures ) , and parental satisfaction and anxiety .


Baseline measurements were performed in infants aged between 5 and 6 months , with follow-up measurements at 8 , 12 , and 24 months .


Primary outcome assessment at 24 months was blinded .


The change score for both plagiocephaly and brachycephaly was equal between the helmet therapy and natural course groups , with a mean difference of -0.2 ( 95 % confidence interval -1.6 to 1.2 , P = 0.80 ) and 0.2 ( -1.7 to 2.2 , P = 0.81 ) , respectively .


Full recovery was achieved in 10 of 39 ( 26 % ) participants in the helmet therapy group and 9 of 40 ( 23 % ) participants in the natural course group ( odds ratio 1.2 , 95 % confidence interval 0.4 to 3.3 , P = 0.74 ) .


All parents reported one or more side effects .


Based on the equal effectiveness of helmet therapy and skull deformation following its natural course , high prevalence of side effects , and high costs associated with helmet therapy , we discourage the use of a helmet as a standard treatment for healthy infants with moderate to severe skull deformation .


Current Controlled Trials ISRCTN18473161 .


PAD is a disabling , chronic condition of the lower extremities that affects approximately 8 million people in the United States .


The purpose of this study was to determine whether an innovative home-based walking exercise program for patients with peripheral artery disease ( PAD ) improves self-efficacy for walking , desire for physical competence , satisfaction for physical functioning , social functioning , and acceptance of PAD related pain and discomfort .


The design was a 6-month randomized controlled clinical trial of 194 patients with PAD .


Participants were randomized to 1 of 2 parallel groups : a home-based group-mediated cognitive behavioral walking intervention or an attention control condition .


Of the 194 participants randomized , 178 completed the baseline and 6-month follow-up visit .


The mean age was 70.66 ( 9.44 ) and was equally represented by men and women .


Close to half of the cohort was African American .


Following 6-months of treatment , the intervention group experienced greater improvement on self-efficacy ( p = .0008 ) , satisfaction with functioning ( p = .0003 ) , pain acceptance ( p = .0002 ) , and social functioning ( p = .0008 ) than the control group ; the effects were consistent across a number of potential moderating variables .


Change in these outcomes was essentially independent of change in 6-minute walk performance .


[ ClinicalTrials.gov Identifier : NCT00693940 ] .


To test whether altered radiation fractionation schemes ( hyperfractionation [ HFX ] , accelerated fractionation , continuous [ AFX-C ] , and accelerated fractionation with split [ AFX-S ] ) improved local-regional control ( LRC ) rates for patients with squamous cell cancers ( SCC ) of the head and neck when compared with standard fractionation ( SFX ) of 70 Gy .


Patients with stage III or IV ( or stage II base of tongue ) SCC ( n = 1076 ) were randomized to 4 treatment arms : ( 1 ) SFX , 70 Gy/35 daily fractions/7 weeks ; ( 2 ) HFX , 81.6 Gy/68 twice-daily fractions/7 weeks ; ( 3 ) AFX-S , 67.2 Gy/42 fractions/6 weeks with a 2-week rest after 38.4 Gy ; and ( 4 ) AFX-C , 72 Gy/42 fractions/6 weeks .


The 3 experimental arms were to be compared with SFX .


With patients censored for LRC at 5 years , only the comparison of HFX with SFX was significantly different : HFX , hazard ratio ( HR ) 0.79 ( 95 % confidence interval 0.62-1 .00 ) , P = .05 ; AFX-C , 0.82 ( 95 % confidence interval 0.65-1 .05 ) , P = .11 .


With patients censored at 5 years , HFX improved overall survival ( HR 0.81 , P = .05 ) .


Prevalence of any grade 3 , 4 , or 5 toxicity at 5 years ; any feeding tube use after 180 days ; or feeding tube use at 1 year did not differ significantly when the experimental arms were compared with SFX .


When 7-week treatments were compared with 6-week treatments , accelerated fractionation appeared to increase grade 3 , 4 or 5 toxicity at 5 years ( P = .06 ) .


When the worst toxicity per patient was considered by treatment only , the AFX-C arm seemed to trend worse than the SFX arm when grade 0-2 was compared with grade 3-5 toxicity ( P = .09 ) .


At 5 years , only HFX improved LRC and overall survival for patients with locally advanced SCC without increasing late toxicity .


To identify the metabolic determinants of type 2 diabetes non-remission status after bariatric surgery at 12 and 24 months .


A total of 40 adults [ mean sd body mass index 36 3 kg/m ( 2 ) , age 48 9 years , glycated haemoglobin ( HbA1c ) 9.7 2 % ) undergoing bariatric surgery [ Roux-en-Y gastric bypass ( RYGB ) or sleeve gastrectomy ( SG ) ] were enrolled in the present study , the Surgical Treatment and Medication Potentially Eradicate Diabetes Efficiently ( STAMPEDE ) trial .


Type 2 diabetes remission was defined as HbA1c < 6.5 % and fasting glucose < 126 mg/dl ( i.e. < 7 mmol/l ) without antidiabetic medication .


Indices of insulin secretion and sensitivity were calculated from plasma glucose , insulin and C-peptide values during a 120-min mixed-meal tolerance test .


Body fat , incretins ( glucagon-like polypeptide-1 , gastric inhibitory peptide , ghrelin ) and adipokines [ adiponectin , leptin , tumour necrosis factor - , high-sensitivity C-reactive protein ( hs-CRP ) ] were also assessed .


At 24 months , 37 patients had available follow-up data ( RYGB , n = 18 ; SG , n = 19 ) .


Bariatric surgery induced type 2 diabetes remission rates of 40 and 27 % at 12 and 24 months , respectively .


Total fat/abdominal fat loss , insulin secretion , insulin sensitivity and - cell function ( C-peptide0-120 / glucose0-120 Matsuda index ) improved more in those with remission at 12 and 24 months than in those without remission .


Incretin levels were unrelated to type 2 diabetes remission , but , compared with those without remission , hs-CRP decreased and adiponectin increased more in those with remission .


Only baseline adiponectin level predicted lower HbA1c levels at 12 and 24 months , and elevated adiponectin correlated with enhanced - cell function , lower triglyceride levels and fat loss .


Smaller rises in adiponectin level , a mediator of insulin action and adipose mass , characterize type 2 diabetes non-remission up to 2 years after bariatric surgery .


Adjunctive strategies promoting greater fat loss and/or raising adiponectin may be key to achieving higher type 2 diabetes remission rates after bariatric surgery .


To evaluate and compare novel robotic guidance and manual approaches based on procedural accuracy , procedural time , procedural performance , image quality as well as patient dose during image-guided microwave thermoablation .


The study was prospectively performed between June 2013 and December 2013 using 70 patients .


Forty randomly selected patients ( group1 ) were treated with manual guidance and 30 patients ( group2 ) were treated using a novel robotic guidance .


Parameters evaluated were procedural accuracy , total procedural time , procedural performance , quantitative/qualitative image quality and patient dose .


Two-sided Student 's t test and Wilcoxon rank-sum test were used to test the significance of the data and p values less than 0.05 were considered statistically significant .


Accuracy parameters were significantly higher in group2 ( all p < 0.05 ) .


Total procedural time showed a mean time difference of 3min ( group2 > group1 ; p = 0.0008 ) .


Volume CT dose index and dose-length product were significantly lower for group2 compared to group1 ( all p < 0.05 ) for CT fluoroscopy imaging .


Total procedural performance score was higher for group2 compared to group1 ( p = 0.0001 ) .


Image quality parameters were insignificant between examined groups .


The novel robotic guided approach improved the accuracy of targeting the target tumour , reduced patient dose and increased procedural performance ( which influences the procedural safety ) during ablation .


Few reports are available in the literature regarding robotic-assisted liver microwave ablation .


The robotic guided approach improved accuracy of localizing the target tumour .


Radiation dose on patients was reduced with the robotic guidance .


Numbers of insertions and readjustments were reduced , lowering chances of complications .


The relationships between pain , stress and anxiety , and their effect on burn wound re-epithelialization have not been well explored to-date .


The aim of this study was to investigate the effect of the Ditto ( a hand-held electronic medical device providing procedural preparation and distraction ) intervention on re-epithelialization rates in acute pediatric burns .


From August 2011 to August 2012 , children ( 4-12 years ) with an acute burn presenting to the Royal Children 's Hospital , Brisbane , Australia fulfilled the study requirements and were randomized to [ 1 ] Ditto intervention or [ 2 ] standard practice .


Burn re-epithelialization , pain intensity , anxiety and stress measures were obtained at every dressing change until complete wound re-epithelialization .


One hundred and seventeen children were randomized and 75 children were analyzed ( n = 40 standard group ; n = 35 Ditto group ) .


Inability to predict wound management resulted in 42 participants no longer meeting the eligibility criteria .


Wounds in the Ditto intervention group re-epithelialized faster than the standard practice group ( -2.14 days ( CI : -4.38 to 0.10 ) , p-value = 0.061 ) , and significantly faster when analyses were adjusted for mean burn depth ( -2.26 days ( CI : -4.48 to -0.04 ) , p-value = 0.046 ) .


Following procedural preparation at the first change of dressing , the Ditto group reported lower pain intensity scores ( -0.64 ( CI : -1.28 , 0.01 ) p = 0.052 ) and lower anxiety ratings ( -1.79 ( CI : -3.59 , 0.01 ) p = 0.051 ) .


At the second and third dressing removals average pain ( FPS-R and FLACC ) and anxiety scores ( VAS-A ) were at least one point lower when Ditto intervention was received .


The Ditto procedural preparation and distraction device is a useful tool alongside pharmacological intervention to improve the rate of burn re-epithelialization and manage pain and anxiety during burn wound care procedures .


Rapid heart rate lowering may be attractive in acute ST-segment elevation myocardial infarction ( STEMI ) .


Accordingly we studied the effect of intravenous ivabradine on heart rate in this setting .


This was a multicenter randomized double-blind placebo-controlled trial : patients aged 40-80 years were randomized after successful primary percutaneous coronary intervention ( PCI ) performed within 6 h of STEMI symptom onset .


Patients were in sinus rhythm and with heart rate > 80 bpm and systolic blood pressure > 90 mm Hg .


They were randomly assigned ( 2:1 ratio ) to intravenous ivabradine ( n = 82 ) ( 5 mg bolus over 30 s , followed by 5 mg infusion over 8 h ) or matching placebo ( n = 42 ) .


The primary outcome measure was heart rate and blood pressure .


In both groups , heart rate was reduced over 8 h , with a faster and more marked decrease on ivabradine than placebo ( 22.2 1.3 vs 8.9 1.8 bpm , p < 0.0001 ) .


After treatment discontinuation , heart rate was similar in both groups .


Throughout the study , there was no difference in blood pressure between groups .


There was no difference in cardiac biomarkers ( creatine kinase ( CK-MB ) , troponin T and troponin I ) .


On echocardiography performed at baseline and post treatment ( median 1.16 days ) , final left ventricular volumes were lower in the ivabradine group both for left ventricular end-diastolic volume ( LVEDV ) ( 87.1 28.2 vs 117.8 21.4 ml , p = 0.01 ) and left ventricular end-systolic volume ( LVESV ) ( 42.5 19.0 versus 59.1 11.3 ml , p = 0.03 ) without differences in volume change or left ventricular ejection fraction .


This pilot study shows that intravenous ivabradine may be used safely to slow the heart rate in STEMI .


Further studies are needed to characterize its effect on infarct size , left ventricular function and clinical outcomes in this population .


The Affordable Care Act provides funding for home-visiting programs to reduce health care disparities , despite limited evidence that existing programs can overcome implementation and evaluation challenges with at-risk populations .


The authors report 36-month outcomes of the paraprofessional-delivered Family Spirit home-visiting intervention for American Indian teen mothers and children .


Expectant American Indian teens ( N = 322 , mean age = 18.1 years ) from four southwestern reservation communities were randomly assigned to the Family Spirit intervention plus optimized standard care or optimized standard care alone .


Maternal and child outcomes were evaluated at 28 and 36 weeks gestation and 2 , 6 , 12 , 18 , 24 , 30 , and 36 months postpartum .


At baseline the mothers had high rates of substance use ( > 84 % ) , depressive symptoms ( > 32 % ) , dropping out of school ( > 57 % ) , and residential instability ( 51 % ) .


Study retention was 83 % .


From pregnancy to 36 months postpartum , mothers in the intervention group had significantly greater parenting knowledge ( effect size = 0.42 ) and parental locus of control ( effect size = 0.17 ) , fewer depressive symptoms ( effect size = 0.16 ) and externalizing problems ( effect size = 0.14 ) , and lower past month use of marijuana ( odds ratio = 0.65 ) and illegal drugs ( odds ratio = 0.67 ) .


Children in the intervention group had fewer externalizing ( effect size = 0.23 ) , internalizing ( effect size = 0.23 ) , and dysregulation ( effect size = 0.27 ) problems .


The paraprofessional home-visiting intervention promoted effective parenting , reduced maternal risks , and improved child developmental outcomes in the U.S. population subgroup with the fewest resources and highest behavioral health disparities .


The methods and results can inform federal efforts to disseminate and sustain evidence-based home-visiting interventions in at-risk populations .


In nonrandomized trials , neoadjuvant treatment was reported to prolong survival in patients with pancreatic cancer .


As neoadjuvant chemoradiation is established for the treatment of rectal cancer we examined the value of neoadjuvant chemoradiotherapy in pancreatic cancer in a randomized phase II trial .


Radiological staging defining resectability was basic information prior to randomization in contrast to adjuvant therapy trials resting on pathological staging .


Patients with resectable adenocarcinoma of the pancreatic head were randomized to primary surgery ( Arm A ) or neoadjuvant chemoradiotherapy followed by surgery ( Arm B ) , which was followed by adjuvant chemotherapy in both arms .


A total of 254 patients were required to detect a 4.33-month improvement in median overall survival ( mOS ) .


The trial was stopped after 73 patients ; 66 patients were eligible for analysis .


Twenty nine of 33 allocated patients received chemoradiotherapy .


Radiotherapy was completed in all patients .


Chemotherapy was changed in 3 patients due to toxicity .


Tumor resection was performed in 23 vs. 19 patients ( A vs. B ) .


The R0 resection rate was 48 % ( A ) and 52 % ( B , P = 0.81 ) and ( y ) pN0 was 30 % ( A ) vs. 39 % ( B , P = 0.44 ) , respectively .


Postoperative complications were comparable in both groups .


mOS was 14.4 vs. 17.4 months ( A vs. B ; intention-to-treat analysis ; P = 0.96 ) .


After tumor resection , mOS was 18.9 vs. 25.0 months ( A vs. B ; P = 0.79 ) .


This worldwide first randomized trial for neoadjuvant chemoradiotherapy in pancreatic cancer showed that neoadjuvant chemoradiation is safe with respect to toxicity , perioperative morbidity , and mortality .


Nevertheless , the trial was terminated early due to slow recruiting and the results were not significant .


ISRCTN78805636 ; NCT00335543 .


Balance and functional abilities are controlled by both sides of the body .


The role of nonparetic side has never been explored for such skills .


The objective of the present study was to examine the effect of a motor therapy program primarily involving the nonparetic side on balance and function in chronic stroke .


A randomized controlled , double blinded trial was conducted on 39 poststroke hemiparetic subjects ( 21 , men ; mean age , 42 years ; mean poststroke duration , 13 months ) .


They were randomly divided into the experimental group ( n = 20 ) and control group ( n = 19 ) .


The participants received either motor therapy focusing on the nonparetic side along with the conventional program or conventional program alone for 8 weeks ( 3 session/week , 60 minutes each ) .


The balance ability was assessed using Berg Balance Scale ( BBS ) and Functional Reach Test ( FRT ) while the functional performance was measured by Barthel Index ( BI ) .


After intervention , the experimental group exhibited significant ( P < 0.05 ) change on BBS ( 5.65 versus 2.52 ) and BI ( 12.75 versus 2.16 ) scores in comparison to the control group .


The motor therapy program incorporating the nonparetic side along with the affected side was found to be effective in enhancing balance and function in stroke .


To compare the efficacy differences between needle-knife therapy and acupuncture-cupping for treatment of cervical spondylosis ( CS ) of cervical type .


Sixty cases of CS were randomly divided into a needle-knife group ( 30 cases ) and an acupuncture-cupping group ( 30 cases ) .


The needle-knife therapy was applied at points among superior nuchal line of occipital bone , bilateral neck muscle , neck centerline , trapezius and medial border scapula for only once .


In the acupuncture-cupping group , acupuncture was applied at Fengchi ( GB 20 ) , Fengfu ( GV 16 ) , Tianzhu ( BL 10 ) , Dazhui ( GV 14 ) , Jianjing ( GB 21 ) , Jiaji ( Ex-B2 , from C4 to C6 ) , Houxi ( SI 3 ) and Ashi point , followed by cupping on local skin , once every other day for totally six times .


The score of neck stiffness and visual analogue scale ( VAS ) were observed before and after treatment , in follow-up of 1 , 3 and 6 months after treatment in the two groups , and the efficacy was compared .


In the needle-knife group , 9 cases were cured , 12 cases were markedly effective , 8 cases were effective and 1 case was failed ; the total effective rate was 96.7 % ( 29/30 ) and the cured and markedly effective rate was 70.0 % ( 21/30 ) .


In the acupuncture-cupping group , 8 cases were cured , 9 cases were markedly effective , 11 cases were effective and 2 cases were failed ; the total effective rate was 93.3 % ( 28/30 ) and the cured and markedly effective rate was 56.7 % ( 17/30 ) .


The difference of total effective rate in the two groups was not statistically significant ( P > 0.05 ) , but the cured and markedly effective rate of needle-knife group was significantly superior to that of acupuncture-cupping group ( P < 0.05 ) .


The needle-knife therapy was significantly superior to acupuncture-cupping on improvement of neck stiffness in the follow-up of 1 , 3 , 6 months after treatment ( P < 0.05 , P < 0.001 ) ; both treatments were effective on relief of neck pain , but the needle-knife group had better effects in the follow-up of 3 and 6 months after treatment compared with acupuncture-cupping group ( both P < 0.01 ) .


The needle-knife therapy has better effects on neck stiffness and pain relief than acupuncture-cupping , and it is more treatment time saving .


We devised a randomised controlled trial to evaluate the effectiveness and efficiency of an intervention based on case management care for frequent emergency department users .


The aim of the intervention is to reduce such patients ' emergency department use , to improve their quality of life , and to reduce costs consequent on frequent use .


The intervention consists of a combination of comprehensive case management care and standard emergency care .


It uses a clinical case management model that is patient-identified , patient-directed , and developed to provide high intensity services .


It provides a continuum of hospital - and community-based patient services , which include clinical assessment , outreach referral , and coordination and communication with other service providers .


We aim to recruit , during the first year of the study , 250 patients who visit the emergency department of the University Hospital of Lausanne , Switzerland .


Eligible patients will have visited the emergency department 5 or more times during the previous 12 months .


Randomisation of the participants to the intervention or control groups will be computer generated and concealed .


The statistician and each patient will be blinded to the patient 's allocation .


Participants in the intervention group ( N = 125 ) , additionally to standard emergency care , will receive case management from a team , 1 ( ambulatory care ) to 3 ( hospitalization ) times during their stay and after 1 , 3 , and 5 months , at their residence , in the hospital or in the ambulatory care setting .


In between the consultations provided , the patients will have the opportunity to contact , at any moment , the case management team .


Participants in the control group ( N = 125 ) will receive standard emergency care only .


Data will be collected at baseline and 2 , 5.5 , 9 , and 12 months later , including : number of emergency department visits , quality of life ( EuroQOL and WHOQOL ) , health services use , and relevant costs .


Data on feelings of discrimination and patient 's satisfaction will also be collected at the baseline and 12 months later .


Our study will help to clarify knowledge gaps regarding the positive outcomes ( emergency department visits , quality of life , efficiency , and cost-utility ) of an intervention based on case management care .


ClinicalTrials.gov Identifier : NCT01934322 .


Different diffusion of different botulinum toxin type A ( BoNTA ) preparations may account for differences in outcomes in cosmetic clinical practice .


A double-blind , randomized , self-controlled study was performed to evaluate the diffusion characteristics of onabotulinumtoxinA and a Chinese type A botulinum toxin ( CBTX-A ) .


Healthy volunteers ( N = 20 ) were recruited to receive a 0.05-mL ( 2U ) injection of BoTNA at four forehead sites ( medial forehead ( subcutaneous ( SC ) ) and temporal forehead ( intradermal ( ID ) ) ) .


On day 14 , the Minor 's iodine starch test was performed and photographs were taken for calculating the area and dimensions of anhydrotic area .


When BoNTAs were different , the anhidrosis ID area was significantly greater with CBTX-A than onabotulinumtoxinA , the vertical dimension was significantly longer with CBTX-A ID than onabotulinumtoxinA ID and the horizontal dimension was significantly greater with CBTX-A ID than onabotulinumtoxinA ID .


The area of anhidrosis SC was significantly greater with CBTX-A than onabotulinumtoxinA .


When injection depths were different , the mean horizontal dimension was significantly greater with onabotulinumtoxinA SC than ID .


Comparing the dimension of the same BoNTA and injection method , the vertical dimension was significantly greater than the horizontal dimension .


OnabotulinumtoxinA diffuses less than CBTX-A .


ID injection technique may result in less diffusion than SC .


Balance and strength training can reduce seniors ' fall risk up to 50 % .


Available evidence suggests that acute bouts of neuromuscular and endurance exercise deteriorate postural control .


High-intensity endurance training has been successfully applied in different populations .


Thus , it seemed valuable to examine the acute effects of high-intensity interval training ( HIIT ) on neuromuscular performance in seniors and young adults .


The acute impact of a HIIT session on balance performance and muscle activity after exercise cessation and during post-exercise recovery was examined in young and old adults .


We intended to investigate whether a transient exercise-induced fall-risk may occur in both groups .


20 healthy seniors ( age 70 ( SD 4 ) years ) and young adults ( age 27 ( SD 3 ) years ) were examined on 3 days .


After exhaustive ramp-like treadmill testing in order to determine maximal heart rate ( HRmax ) on the first day , either a 4 4 min HIIT at 90 % of HRmax or a control condition ( CON ) was randomly performed on the second and third day , respectively .


Balance performance ( postural sway ) was assessed during single limb stance with open eyes ( SLEO ) and double limb stance with closed eyes ( DLEC ) .


EMG was recorded for the soleus ( SOL ) , anterior tibialis ( TIB ) , gastrocnemius ( GM ) and peroneus longus ( PL ) muscles at the dominant leg .


All measures were collected before , immediately as well as 10 , 30 and 45 min after HIIT and CON , respectively .


Compared to CON , HIIT induced significant increases of postural sway immediately after exercise cessation during SLEO in both groups ( adults : p < 0.001 , = +25 % sway ; seniors : p = 0.007 , = +15 % sway ) .


Increased sway during DLEC was only found for seniors immediately and 10 min after HIIT ( post : p = 0.003 , = +14 % sway , 10 min post : p = 0.004 , = +18 % sway ) .


Muscle activity was increased during SLEO for TIB until 10 min post in seniors ( 0.008 < p < 0.03 ) and immediately after HIIT in adults ( p < 0.001 ) .


HIIT training may cause an acute ` open-fall-window ' with a transient impairment of balance performance for at least 10 min after exercise cessation in both groups .


Occluded vision in seniors seems to prolong this period up to 30 min .


Thus , the advantage of HIIT with regard to time efficiency seems debatable when considering transient HIIT-induced impairments of neuromuscular function .


Cognitive Behaviour Therapy ( CBT ) based self-help has been found to be effective for treating depression and anxiety .


There is some evidence to suggest that CBT needs to be culturally adapted for it to be effective in non-Western cultures .


CBT is not widely used in low and middle income countries and there is a need to test its effectiveness in different settings and formats , including self-help .


We describe a RCT of a Culturally adapted CBT ( CaCBT ) based self-help manual in Pakistan .


The trial was conducted in psychiatry departments in three cities .


Assessments were carried out at baseline and at 12 weeks , using Hospital Anxiety and Depression Scale , Bradford somatic Inventory and brief disability Questionnaire .


At the end of the trial CaCBT based self-help was found to be effective against care as usual in reducing the symptoms of depression and anxiety , as well as somatic symptoms and disability .


This study was conducted only in secondary care and required either patient or a carer to be able to read and write .


This is the first study outside West of a CBT based self-help intervention for depression .


This study highlights the importance of using cost effective interventions in developing world in low intensity formats .


Future studies should focus on trying these resources in different settings , like primary care , and with the use of audio/video or multimedia resources to improve compliance in patients with lower literacy .


To evaluate whether provision of fixed dose combination treatment improves adherence and risk factor control compared with usual care of patients at high risk of cardiovascular disease in primary care .


Open label randomised control trial : IMPACT ( IMProving Adherence using Combination Therapy ) .


54 general practices in the Auckland and Waikato regions of New Zealand , July 2010 to August 2013 .


513 adults ( including 257 indigenous Mori ) at high risk of cardiovascular disease ( established cardiovascular disease or five year risk 15 % ) who were recommended for treatment with antiplatelet , statin , and two or more blood pressure lowering drugs .


497 ( 97 % ) completed 12 months ' follow-up .


Participants were randomised to continued usual care or to fixed dose combination treatment ( with two versions available : aspirin 75 mg , simvastatin 40 mg , and lisinopril 10 mg with either atenolol 50 mg or hydrochlorothiazide 12.5 mg ) .


All drugs in both treatment arms were prescribed by their usual general practitioners and dispensed by local community pharmacists .


Primary outcomes were self reported adherence to recommended drugs ( antiplatelet , statin , and two or more blood pressure lowering agents ) and mean change in blood pressure and low density lipoprotein cholesterol at 12 months .


Adherence to all four recommended drugs was greater among fixed dose combination than usual care participants at 12 months ( 81 % v 46 % ; relative risk 1.75 , 95 % confidence interval 1.52 to 2.03 , P < 0.001 ; number needed to treat 2.9 , 95 % confidence interval 2.3 to 3.7 ) .


Adherence for each drug type at 12 months was high in both groups but especially in the fixed dose combination group : for antiplatelet treatment it was 93 % fixed dose combination v 83 % usual care ( P < 0.001 ) , for statin 94 % v 89 % ( P = 0.06 ) , for combination blood pressure lowering 89 % v 59 % ( P < 0.001 ) , and for any blood pressure lowering 96 % v 91 % ( P = 0.02 ) .


Self reported adherence was highly concordant with dispensing data ( dispensing of all four recommended drugs 79 % fixed dose combination v 47 % usual care , relative risk 1.67 , 95 % confidence interval 1.44 to 1.93 , P < 0.001 ) .


There was no statistically significant improvement in risk factor control between the fixed dose combination and usual care groups over 12 months : the difference in systolic blood pressure was -2.2 mm Hg ( -4.5 v -2.3 , 95 % confidence interval -5.6 to 1.2 , P = 0.21 ) , in diastolic blood pressure -1.2 mm Hg ( -2.1 v -0.9 , -3.2 to 0.8 , P = 0.22 ) and in low density lipoprotein cholesterol -0.05 mmol/L ( -0.20 v -0.15 , -0.17 to 0.08 , P = 0.46 ) .


The number of participants with cardiovascular events or serious adverse events was similar in both treatment groups ( fixed dose combination 16 v usual care 18 ( P = 0.73 ) , 99 v 93 ( P = 0.56 ) , respectively ) .


Fixed dose combination treatment was discontinued in 94 participants ( 37 % ) .


The most commonly reported reason for discontinuation was a side effect ( 54/75 , 72 % ) .


Overall , 89 % ( 227/256 ) of fixed dose combination participants ' general practitioners completed a post-trial survey , and the fixed dose combination strategy was rated as satisfactory or very satisfactory for starting treatment ( 206/227 , 91 % ) , blood pressure control ( 180/220 , 82 % ) , cholesterol control ( 170/218 , 78 % ) , tolerability ( 181/223 , 81 % ) , and prescribing according to local guidelines ( 185/219 , 84 % ) .


When participants were asked at 12 months how easy they found taking their prescribed drugs , most responded very easy or easy ( 224/246 , 91 % fixed dose combination v 212/246 , 86 % usual care , P = 0.09 ) .


At 12 months the change in other lipid fractions , difference in EuroQol-5D , and difference in barriers to adherence did not differ significantly between the treatment groups .


Among this well treated primary care population , fixed dose combination treatment improved adherence to the combination of all recommended drugs but improvements in clinical risk factors were small and did not reach statistical significance .


Acceptability was high for both general practitioners and patients , although the discontinuation rate was high .


Australian New Zealand Clinical Trial Registry ACTRN12606000067572 .


We investigated the effect of resistance exercise intensity and exercise-induced metabolic stress on the activation of anabolic signaling and expression of myogenic genes in skeletal muscle .


Ten strength-trained athletes performed high-intensity [ HI , 74 % of 1-repetition maximum ( RM ) ] , middle-intensity ( MI , 54 % 1RM ) , or middle-intensity ( 54 % 1RM ) no-relaxation exercise ( MIR ) .


Kinase phosphorylation level and myogenic gene expression in muscle samples were evaluated before , 45 min , 5 h , and 20 h after exercise .


The lactate concentration in MI was approximately 2-fold lower than in the 2 other sessions , and was highest in MIR .


The phosphorylation level of extracellular kinase 1/2Thr202/Tyr204 after exercise was related to metabolic stress .


Metabolic stress induced a decrease in myostatin mRNA expression , whereas mechano-growth factor mRNA level depended on exercise intensity .


This study demonstrates that both intensity and exercise-induced metabolic stress can be manipulated to affect muscle anabolic signaling .


Acne vulgaris is common in Asian populations .


We compared three methods of phototherapy for the treatment of moderate to severe facial acne vulgaris in Chinese patients .


Patients were randomly assigned to receive photodynamic therapy ( PDT ) , intense pulsed light ( IPL ) or blue-red light-emitting diode ( LED ) phototherapy to the right side of the face until the inflammatory lesion count reduced by 90 % .


Patients were examined at 1 and 3 months after the final treatment .


We enrolled 150 patients ( 92 males ; mean age , 28 years ) .


At 1 month , 90 % clearance or moderate improvement occurred in 46/50 ( 92 % ) , 29/50 ( 58 % ) and 22/50 ( 44 % ) patients in the PDT , IPL and LED groups , respectively ( mean number of sessions required , PDT : 31.52 ; IPL : 62.15 ; LED : 93.34 ) .


Forty-six ( 92 % ) patients experienced mild to moderate pain , erythema and edema after PDT , which resolved within 5-7 days .


Slight erythema and stinging were reported immediately after IPL and LED , resolving within 2h .


After 3 months , minimal papules and pustules were observed in 4 patients in the PDT group , 7 in the IPL group and 12 in the LED group , but no nodular pustules recurred .


Phototherapy is efficacious for moderate to severe facial acne vulgaris .


To explore the associations of green tea and rock tea consumption with risk of impaired fasting glucose ( IFG ) and impaired glucose tolerance ( IGT ) .


A multistage , stratified , cluster , random-sampling method was used to select a representative sample from Fujian Province in China .


In total , 4808 subjects without cardiovascular disease , hypertension , cancer , or pancreatic , liver , kidney , or gastrointestinal diseases were enrolled in the study .


A standard questionnaire was used to gather data on tea ( green , rock , and black ) consumption and other relevant factors .


The assessment of impaired glucose regulation ( IGR ) was using 75-g oral glucose tolerance test ( OGTT ) , the diagnostic criteria of normal glucose tolerance was according to American Diabetes Association .


Green tea consumption was associated with a lower risk of IFG , while rock tea consumption was associated with a lower risk of IGT .


The adjusted odds ratios for IFG for green tea consumption of < 1 , 1-15 , 16-30 , and > 30 cups per week were 1.0 ( reference ) , 0.42 ( 95 % confidence intervals ( CI ) 0.27-0 .65 ) , 0.23 ( 95 % CI , 0.12-0 .46 ) , and 0.41 ( 95 % CI , 0.17-0 .93 ) , respectively .


The adjusted odds ratios for IGT for rock tea consumption of < 1 , 1-15 , 16-30 , and > 30 cups per week were 1.0 ( reference ) , 0.69 ( 95 % CI , 0.48-0 .98 ) , 0.59 ( 95 % CI , 0.39-0 .90 ) , and 0.64 ( 95 % CI , 0.43-0 .97 ) , respectively .


A U-shaped association was observed , subjects who consumed 16-30 cups of green or rock tea per week having the lowest odds ratios for IFG or IGT .


Consumption of green or rock tea may protect against the development of type 2 diabetes mellitus in Chinese men and women , particularly in those who drink 16-30 cups per week .


Convenient dosing , potency , and low toxicity support use of tenofovir disoproxil fumarate ( TDF ) as preferred nucleotide reverse transcriptase inhibitor ( NRTI ) for HIV-1 treatment .


However , renal and metabolic safety of TDF compared to other NRTIs has not been well described in resource-limited settings .


This was a secondary analysis examining the occurrence of renal abnormalities ( RAs ) and renal and metabolic serious non-AIDS-defining events ( SNADEs ) through study follow-up between participants randomized to zidovudine ( ZDV ) / lamivudine / efavirenz and TDF/emtricitabine/efavirenz treatment arms within A5175/PEARLS trial .


Exact logistic regression explored associations between baseline covariates and RAs .


Response profile longitudinal analysis compared creatinine clearance ( CrCl ) over time between NRTI groups .


Twenty-one of 1,045 participants developed RAs through 192 weeks follow-up ; there were 15 out of 21 in the TDF arm ( P = .08 ) .


Age 41 years or older ( odds ratio [ OR ] , 3.35 ; 95 % CI , 1.1-13 .1 ) , his - tory of diabetes ( OR , 10.7 ; 95 % CI , 2.1-55 ) , and lower baseline CrCl ( OR , 3.1 per 25 mL/min decline ; 95 % CI , 1.7-5 .8 ) were associated with development of RAs .


Renal SNADEs occurred in 42 participants ; 33 were urinary tract infections and 4 were renal failure/insufficiency ; one event was attributed to TDF .


Significantly lower CrCl values were maintained among patients receiving TDF compared to ZDV ( repeated measures analysis , P = .05 ) , however worsening CrCl from baseline was not observed with TDF exposure over time .


Metabolic SNADEs were rare , but were higher in the ZDV arm ( 20 vs 3 ; P < .001 ) .


TDF is associated with lower serious metabolic toxicities but not higher risk of RAs , serious renal events , or worsening CrCl over time compared to ZDV in this randomized multinational study .


To observe clinical curative effect of cake-separated moxibustion on impaired glucose regulation ( IGR ) and explore its action mechanism .


Sixty cases were randomly divided into a simple lifestyle intervention group ( control group ) and a cake-separated moxibustion combined with lifestyle intervention group ( observation group ) , 30 cases in each one .


The control group was treated with lifestyle intervention .


Based on lifestyle intervention , cake-separated moxibustion at Pishu ( BL 20 ) , Weishu ( BL 21 ) and Yishu ( EX-B 3 ) was applied to the observation group .


Fast plasma glucose ( FPG ) , two hours plasma glucose after oral glucose tolerance test ( OGTT2hPG ) , fasting insulin ( FINS ) , homa insulin resistance index ( HOMA-IR ) , blood lipid , body mass index ( BMI ) and waist circumference ( WC ) were observed in the two groups before and after treatment .


After treatment , the OGTT2hPG and FPG were both decreased significantly ( both P < 0.05 ) in the two groups , compared between the two groups , the differences of FPG [ ( 0.41 + / - 0.42 ) mmol/L vs ( 0.05 + / - 0.08 ) mmol/L ] and OGTT2hPG [ ( 0.85 + / - 0.53 ) mmol/L vs ( 0.17 + / - 0.19 ) mmol/L ] were both statistically significant .


There were no significant changes in FINS , HOMA-IR , blood lipid , BMI and WC in the control group before and after treatment ( all P > 0.05 ) , but FINS , HOMA-IR levels , triglycerides ( TG ) , total cholest-erol ( TC ) , low density lipoprotein ( LDL-C ) , BMI and WC in the observation group were decreased obviously after treatment ( all P < 0.05 ) , which had statistical differences between the two groups ( all P < 0.05 ) .


The cake-separated moxibustion combined with lifestyle intervention can obviously control blood glucose levels , improve insulin resistance and blood lipid levels , decrease BMI and WC .


Previous research shows that the internet can be used in the rehabilitation of hearing-aid users .


By further developing the online program , it might be possible to foster behavioral changes that will positively affect hearing-aid users .


A randomized controlled study with two groups of participants .


The intervention group underwent a five-week online intervention while the control group was referred to a waiting list .


Questionnaires were used as outcome measures .


Seventy-six experienced hearing-aid users participated in the study , ranging in age from 26 to 81 years ( mean 69.3 years ) .


The findings showed significant improvements in the intervention group after the intervention , measured by the hearing handicap inventory for the elderly .


The effects were maintained and improved at the follow-up .


Furthermore , the results indicated that the participants in the intervention group improved at two items of the international outcome inventory for hearing aids , and the effects were partly maintained at the follow-up .


Finally , significant improvements in the domain of psychosocial wellbeing were found at the follow-up .


This study provides further evidence that the internet can be used to deliver intervention of rehabilitation to hearing-aid users .


A train-of-four ratio ( TOFR ) 0.9 measured by quantitative neuromuscular monitoring is accepted as an indication of sufficient neuromuscular recovery for extubation , even though many postsynaptic acetylcholine receptors may still be inhibited .


We investigated whether antagonism with sugammadex after spontaneous recovery to TOFR0 .9 further improves muscle function or subjective well-being .


Following recovery to TOFR0 .9 and emergence from anaesthesia , 300 patients randomly received either sugammadex 1.0 mg kg ( -1 ) or placebo .


Fine motor function ( Purdue Pegboard Test ) and maximal voluntary grip strength were measured before and after surgery ( before and after test drug administration ) .


At discharge from the postanaesthesia care unit , well-being was assessed with numerical analogue scales and the Quality-of-Recovery Score 40 ( QoR-40 ) .


Patients ' fine motor function [ 6 ( sd 4 ) vs 15 ( 3 ) pegs ( 30 s ) ( -1 ) , P < 0.05 ] and maximal voluntary grip strength ( 284 ( 126 ) vs 386 ( 125 ) N , P < 0.05 ) were significantly lower after anaesthesia compared with the pre-anaesthesia baseline .


After sugammadex or placebo , motor function was significantly improved in both groups but did not reach the preoperative level .


There was no difference between groups at any time .


Global well-being was unaffected ( QoR-40 : placebo , 174 vs 185 ; sugammadex , 175 vs 186 , P > 0.05 ) .


Antagonizing rocuronium at TOF0 .9 with sugammadex 1.0 mg kg ( - ) ( 1 ) did not improve patients ' motor function or well-being when compared with placebo .


Our data support the view that TOFR0 .9 measured by electromyography signifies sufficient recovery of neuromuscular function .


The trial is registered at ClinicalTrials.gov ( NCT01101139 ) .


We aimed to compare the incidence of contrast-induced nephropathy ( CIN ) between atorvastatin versus rosuvastatin in patients with ST-segment elevation myocardial infarction ( STEMI ) undergoing primary coronary angioplasty .


One hundred ninety-two consecutive patients , who underwent primary percutaneous intervention ( p-PCI ) with the diagnosis of STEMI , were included in the study .


The patients were randomized to take atorvastatin 80 mg ( n = 98 ) or rosuvastatin 40 mg ( n = 94 ) before the procedure .


Biochemical and complete blood count measurements were done at baseline and at 48 hours following admission .


The incidence of CIN was 8.9 % ( n = 17 ) in the entire groups .


The analysis performed between the statin groups revealed no statistical difference in any of the renal dysfunction indicators [ baseline creatinine , baseline estimated glomerular filtration rate ( eGFR ) , creatinine at 48 h , eGFR at 48 h , difference between baseline and 48 h creatinine , the per cent increase in the creatinine at 48 hours relative to basal creatinine ] .


In STEMI patients undergoing primary PCI , only the amount of the contrast agent administered was determined to be an independent predictor for CIN ( OR and 95 % CI : 1.08 ( 1.03 - 1.13 ) , P < or = 0.001 ) .


Left ventricular ejection fraction exhibited borderline statistical significance ( OR and 95 % CI : 0.88 ( 0.77-1 .01 ) , P = 0.07 ) .


Atorvastatin and rosuvastatin had similar efficacy in preventing CIN in patients with STEMI undergoing P-PCI .


The primary aim of this study was to examine the impact of physical activity ( PA ) in the natural environment ( eg , `` green exercise '' ) on resting autonomic function in the Walks4Work intervention .


A secondary aim was to assess the feasibility of Walks4Work in terms of adherence , change in PA levels , and cardiovascular health parameters .


In an 8-week randomized control trial , 94 office workers in an international company were allocated to one of three groups : control , nature ( NW ) , or built ( BW ) lunchtime walking route .


Both walking groups were required to undertake two lunchtime walks each week .


The NW route centered around trees , maintained grass , and public footpaths .


In contrast , the BW consisted of pavement routes through housing estates and industrial areas .


Data were collected at baseline and following the intervention .


To investigate the impact of the intervention , mixed-design analysis of variance ( ANOVA ) were performed .


A total of 73 participants completed the intervention ( drop-out rate of 22 % ) .


No difference was observed in resting autonomic function between the groups .


Self-reported mental health improved for the NW group only .


PA levels increased at the intervention mid-point for all groups combined but adherence to the intervention was low with rates of 42 % and 43 % within the BW and NW groups , respectively .


Accompanying a guideline of two active lunchtimes per week with low facilitator input appears inadequate for increasing the number of active lunchtimes and modifying cardiovascular health parameters in an office population .


However , this population fell within normal ranges for cardiovascular measures and future research should consider investigating at-risk populations , particularly hypertensive individuals .


Piriformis syndrome ( PS ) , which is characterized by pain radiating to the gluteal region and posterior leg , is accepted as one of the causes of sciatalgia .


Although the importance of local piriformis muscle injections whenever PS is clinically suspected has been shown in many studies , there are not enough studies considering the clinical efficacy of these injections .


To investigate the differences between local anesthetic ( LA ) and LA + corticosteroid ( CS ) injections in the treatment of PS .


A prospective , double-blinded , randomized controlled trial .


Physical medicine and rehabilitation department of a university hospital .


Fifty-seven patients having unilateral hip and/or leg pain with positive FAIR test and tenderness and/or trigger point at the piriformis muscle were evaluated .


Out of 50 patients randomly assigned to 2 groups , 47 patients whose pain resolved at least 50 % from the baseline after the injection were diagnosed as having PS .


The first group ( n = 22 ) received 5 mL of lidocaine 2 % while the second group ( n = 25 ) received 4 mL of lidocaine 2 % + 1 mL of betametazone under the guidance of ultrasound .


Numeric Rating Scale ( NRS ) and Likert Analogue Scale ( LAS ) .


No statistically significant difference ( P > 0.05 ) was detected between the groups in NRS score values at resting ( P = 0.814 ) , night ( P = 0.830 ) , and in motion ( P = 0.145 ) , and LAS values with long duration of sitting ( P = 0.547 ) , standing ( P = 0.898 ) , and lying ( P = 0.326 ) with evaluations at baseline , first week , and first and third months after the injection .


A statistically highly significant ( P < 0.005 ) reduction of pain was evaluated through NRS scores at resting ( P = 0.001 ) , in motion ( P = 0.001 ) , and at night ( P = 0.001 ) and LAS values with long duration of sitting ( P = 0.001 ) , standing ( P = 0.001 ) , and lying ( P = 0.001 ) in both of the groups .


Presumed limitations of this study include having a relatively small sample .


LA injections for the PS were found to be clinically effective .


However , addition of CS to LA did not give an additional benefit .


This gives us the idea that PS is mostly muscular in origin and responds well to both LA and LA+CS injections .


Patient information in cancer clinical trial is challenging .


The value of audio-recording interventions for patients considering participating in clinical trials is unclear .


The primary aim of this randomized study was to investigate effects of audio-recorded information on knowledge and understanding in patients considering participation in a clinical trial .


Patients scheduled for information about a phases 2 or 3 trial by one of the 13 participating oncologists at the Department of Oncology during the study period ( 2008-2013 ) were eligible .


The intervention consisted of an audio-recording on compact disc ( CD ) of the information at the medical consultation in which the patients were informed about a trial .


Knowledge and understanding was measured by the questionnaire , Quality of Informed Consent .


A total of 130 patients were randomized , 70 % of the calculated sample size ( n = 186 ) .


Sixty-seven patients were randomized to the intervention .


In total , 101 patients ( 78 % ) completed questionnaires .


No statistical significant differences were found between the groups with respect to knowledge and understanding .


The level of knowledge was relatively high , with the exceptions of the risks associated with , and the unproven nature of , the trial .


Overall , patients who declined participation scored statistically significant lower on knowledge .


The present study was underpowered and the results should therefore be interpreted with caution .


Still , 130 patients were included with a response rate of 78 % .


A CD including the oral information about a clinical trial did not show any effects on knowledge or understanding .


However , the levels of knowledge were high , possible due to the high levels of education in the study group .


Information on risks associated with the trial is still an area for improvement .


To evaluate the long-term durability of the efficacy of alogliptin compared with glipizide in combination with metformin in people with type 2 diabetes inadequately controlled on stable-dose metformin .


This multicentre , double-blind , active-controlled study randomized 2639 patients aged 18-80 years to 104 weeks of treatment with metformin in addition to alogliptin 12.5 mg once daily ( n = 880 ) , alogliptin 25 mg once daily ( n = 885 ) or glipizide 5 mg once daily , titrated to a maximum of 20 mg ( n = 874 ) .


The primary endpoint was least square mean change from baseline in HbA1c level at 104 weeks .


The mean patient age was 55.4 years , the mean diabetes duration was 5.5 years and the mean baseline HbA1c was 7.6 % .


HbA1c reductions at week 104 were -0.68 % , -0.72 % and -0.59 % for alogliptin 12.5 and 25 mg and glipizide , respectively [ both doses met the criteria for non-inferiority to glipizide ( p < 0.001 ) ; alogliptin 25 mg met superiority criteria ( p = 0.010 ) ] .


Fasting plasma glucose concentration decreased by 0.05 and 0.18 mmol/l for alogliptin 12.5 and 25 mg , respectively , and increased by 0.30 mmol/l for glipizide ( p < 0.001 for both comparisons with glipizide ) .


Mean weight changes were -0.68 , -0.89 and 0.95 kg for alogliptin 12.5 and 25 mg and glipizide , respectively ( p < 0.001 for both comparisons with glipizide ) .


Hypoglycaemia occurred in 23.2 % of patients in the glipizide group vs. 2.5 and 1.4 % of patients in the alogliptin 12.5 and 25 mg groups , respectively .


Pancreatitis occurred in one patient in the alogliptin 25 mg group and three in the glipizide group .


Alogliptin efficacy was sustained over 2 years in patients with inadequate glycaemic control on metformin alone .


To study differences in outcomes of medication reconciliation ( MR ) when performed by clinical pharmacists compared to nurses .


201 patients ( 21-92 years ) admitted to the Department of Cardiology at the University Hospital of North Norway , autumn 2012 , were randomized into a pharmacist group ( PG ) and a nurse group ( NG ) .


The nurses and the pharmacists were trained for performing the MR process by an independent clinical pharmacist .


Medication discrepancies ( MDs ) were discussed with the physicians .


Time spent during the MR was recorded .


An independent expert group rated clinical relevance of the MDs retrospectively .


At least one MD was identified in 78 % and 84 % of patients in PG and NG , respectively ( P = 0.269 ) with a mean number of MDs per patient 3.1 ( SD 2.1 ) and 2.8 ( SD 2.2 ) , respectively ( P = 0.528 ) .


Mean time spent/patient on the MR process was 22.9 min ( SD 11.6 ) in the PG and 32.2 min ( SD 20.3 ) in the NG ( P < 0,001 ) .


Physicians agreed significantly more often to act upon the MDs presented by pharmacists compared to nurses ( P = 0.001 ) .


The expert group finally assessed 48 % and 49 % of the MDs to be of the clinical relevance in the PG and the NG , respectively .


By applying a structured method for MR , a small however not statistically significant difference in identified MDs between nurses and clinical pharmacists was revealed .


The pharmacists spent significantly less time than the nurses , and physicians agreed significantly more often with the pharmacist that action should be taken on the MDs .


This is important in the discussion of who to perform MR.


The premotor cortex plays a major role in motor planning and control , exhibiting hierarchical importance comparable to that of the primary motor cortex ( M1 ) .


In this study , we compared the effects of cPMd modulation , which was achieved using inhibitory repetitive transcranial magnetic stimulation ( rTMS ) , with those of contralesional M1 ( cM1 ) modulation , to elucidate the roles of both regions on longitudinal motor recovery following a stroke .


Forty-four patients who had sustained hemiplegia for 3 to 12 months were randomly allocated to a cPMd group , cM1 group , or sham group and received 10 sessions of 1-Hz rTMS .


The Medical Research Council ( MRC ) Scale , Fugl-Meyer Assessment ( FMA ) , Wolf Motor Function Test ( WMFT ) , and a cortical excitability test were administered pre - and post - rTMS intervention .


cPMd modulation yielded significant improvements in MRC , FMA , and WMFT scores compared with sham stimulation and a significant effect on cortical excitability suppression equivalent to that of cM1 modulation , but engendered effects on motor improvement inferior to those of cM1 modulation .


In patients with chronic stroke , the cPMd can fulfill a role similar to that of the cM1 in interhemispheric imbalance , which can be ameliorated by applying inhibitory rTMS to achieve substantial motor restoration .


The aim of the present clinical study was to compare early and late outcomes after inguinal hernia repair with the heavyweight mesh ( HW ) and lightweight mesh ( LW ) during a 3 year follow-up period .


226 patients were randomized into LW and HW mesh groups , both of which underwent unilateral primary inguinal hernia repair via the Lichtenstein technique .


Wound complications ( infection , hematoma , seroma ) , hernia recurrence , pain and feeling of foreign body in inguinal area were determined in patients .


Pain was measured by visual analogue scale .


No statistical difference has been found between LW and HW groups by wound complication ( P = 0.80 ) .


One case of hernia recurrence has been mentioned in both groups one year after hernioplasty .


But there was no detectable difference between the two groups .


No significant difference has been found between LW and HW groups by frequency of chronic pain 7 days , 1 and 3 months , 1 , 2 , and 3 years after surgery .


As for the feeling of foreign body in groin it is similar in both groups after 1 and 3 months .


Level of feeling of foreign body was significantly lower in LW group 1 , 2 , and 3 years after surgery , than in HW group ( P = 0.03 , P = 0.02 , P = 0.02 , respectively ) .


Our research shows no significant difference in wound complications , hernia recurrence and chronic pain after Lichtenstein hernioplasty , by using of LW and HW meshes .


The usage of the LW mesh was associated with less feeling of foreign body than that of the HW mesh , what can be considered as prevalence of LW mesh hernioplasty .


The present pharmacoeconomic study compared the direct and indirect costs of using frovatriptan versus rizatriptan in the acute treatment of migraine .


Data on the cost-efficacy of the two triptans were derived from a recently published Italian , multicenter , randomized , double-blind , cross-over patient preference study , comparing frovatriptan versus rizatriptan .


The direct costs were obtained by calculating the drug consumption , both of triptans and rescue medications .


Prices of currently marketed drugs were obtained from Italian Drug Agency price list .


The indirect costs were those related to absenteeism from the workplace due to migraine .


129 of the 148 patients with a current history of migraine randomized to the two study drugs and completing the study were analyzed .


The number of attacks treated with only 1 dose of study drug was higher with frovatriptan ( 157 vs. 147 ) , whereas the number of attacks treated with 2 doses of study medication was higher with rizatriptan ( 122 vs. 110 and 74 vs. 67 , respectively ) .


However , more patients treated with frovatriptan took a rescue medication ( 71 vs. 59 ) .


The total direct cost per attack ( including study drug rescue medication ) was 9.12 for frovatriptan and 13.54 for rizatriptan ( p < 0.05 between-treatments ) .


As for indirect costs , in the group of patients treated with frovatriptan the mean number of lost working hours was significantly ( p < 0.05 ) lower ( 1.5 h ) compared to the subjects who used rizatriptan ( 2.8 h ) .


Based on the earned income per unit of work , indirect costs per attack resulted to be 24.55 for frovatriptan and 45.84 for rizatriptan .


Overall , the total costs , including direct and indirect costs , were evaluated to be 33.67 for frovatriptan and 59.38 for rizatriptan , respectively .


Within the limitations of this model analysis , frovatriptan was found to be significantly more cost-effective than rizatriptan .


This outcome can be explained by the lower acquisition cost of frovatriptan , the need for fewer doses , and the loss of fewer working hours .


This finding could drive selection of the most appropriate oral treatment for acute migraine attacks based on both individual patient 's needs and the cost-effectiveness of the available drugs .


2006-002572-17 ( EudraCT ) .


To assess an intervention to limit community-associated methicillin-resistant Staphylococcus aureus ( MRSA ) dissemination .


Randomized , controlled trial .


County Jail , Dallas , Texas .


A total of 4,196 detainees in 68 detention tanks .


Tanks were randomly assigned to 1 of 3 groups : in group 1 , detainees received cloths that contained chlorhexidine gluconate ( CHG ) to clean their entire skin surface 3 times per week for 6 months ; group 2 received identical cloths containing only water ; and group 3 received no skin treatment .


During the study , all newly arrived detainees were invited to enroll .


Nares and hand cultures were obtained at baseline and from all current enrollees at 2 and 6 months .


At baseline , S. aureus was isolated from 41.2 % and MRSA from 8.0 % ( nares and/or hand ) of 947 enrollees .


The average participation rate was 47 % .


At 6 months , MRSA carriage was 10.0 % in group 3 and 8.7 % in group 1 tanks ( estimated absolute risk reduction [ 95 % confidence interval ( CI ) ] , 1.4 % [ -4.8 % to 7.1 % ] ; P = .655 ) .


At 6 months , carriage of any S. aureus was 51.1 % in group 3 , 40.7 % in group 1 ( absolute risk reduction [ 95 % CI ] , 10.4 % [ 0.01 % -20.1 % ] ; P = .047 ) , and 42.8 % ( absolute risk reduction [ 95 % CI ] , 8.3 % [ -1.4 % to 18.0 % ] ; P = .099 ) in group 2 .


Skin cleaning with CHG for 6 months in detainees , compared with no intervention , significantly decreased carriage of S. aureus , and use of water cloths produced a nonsignificant but similar decrease .


A nonsignificant decrease in MRSA carriage was found with CHG cloth use .


ClinicalTrials.gov identifier NCT00785200 .


Health and social care professionals are well positioned to identify and intervene in cases of elder financial abuse .


An evidence-based educational intervention was developed to advance practitioners ' decision-making in this domain .


The objective was to test the effectiveness of a decision-training educational intervention on novices ' ability to detect elder financial abuse .


The research was funded by an E.S.R.C. grant reference RES-189-25-0334 .


A parallel-group , randomised controlled trial was conducted using a judgement analysis approach .


Each participant used the World Wide Web to judge case sets at pre-test and post-test .


The intervention group was provided with training after pre-test testing , whereas the control group were purely given instructions to continue with the task .


154 pre-registration health and social care practitioners were randomly allocated to intervention ( n78 ) or control ( n76 ) .


The intervention comprised of written and graphical descriptions of an expert consensus standard explaining how case information should be used to identify elder financial abuse .


Participants ' ratings of certainty of abuse occurring ( detection ) were correlated with the experts ' ratings of the same cases at both stages of testing .


At pre-test , no differences were found between control and intervention on rating capacity .


Comparison of mean scores for the control and intervention group at pre-test compared to immediate post-test , showed a statistically significant result .


The intervention was shown to have had a positive moderate effect ; at immediate post-test , the intervention group 's ratings had become more similar to those of the experts , whereas the control 's capacity did not improve .


The results of this study indicate that the decision-training intervention had a positive effect on detection ability .


This freely available , web-based decision-training aid is an effective evidence-based educational resource .


Health and social care professionals can use the resource to enhance their ability to detect elder financial abuse .


It has been embedded in a web resource at http://www.elderfinancialabuse.co.uk .


Imiquimod , a synthetic Toll-like receptor 7 agonist enhanced immunogenicity of influenza vaccine in a mouse model .


We hypothesized that topical imiquimod before intradermal influenza vaccination ( TIV ) would produce similar effect in human .


We performed a prospective 1-year follow-up , double-blind , randomized , controlled trial with adults with comorbidities .


Participants were randomized to 1 of the following 3 vaccinations : topical 5 % 250 mg imiquimod ointment followed by intradermal TIV , topical aqueous-cream followed by intradermal TIV , or topical aqueous-cream followed by intramuscular TIV .


Patients and investigators were blinded to the type of topical treatment applied .


Hemagglutination inhibition ( HI ) and microneutralization antibody titers were measured .


The primary outcome was the day 7 seroconversion rate .


Ninety-one recruited participants completed the study .


The median age was 73 years .


On day 7 , 27/30 ( 90 % ) patients who received imiquimod and intradermal TIV achieved seroconversion against the H1N1 strain by HI , compared with 4/30 ( 13.3 % ) who received aqueous-cream and intramuscular TIV ( P < .001 ) , and 12/31 ( 38.7 % ) who received aqueous-cream and intradermal TIV ( P < .001 ) .


The seroconversion , seroprotection , and geometric mean titer-fold increase were met in all 3 strains in the imiquimod and intradermal TIV group 2 weeks earlier , and the better seroconversion rate was sustained from day 7 to year 1 ( P .001 ) .


The better immunogenicity was associated with fewer hospitalizations for influenza or pneumonia ( P < .05 ) .


All adverse reactions were self-limited .


Pretreatment with topical imiquimod significantly expedited , augmented , and prolonged the immunogenicity of influenza vaccination .


This strategy for influenza immunization should be considered for the elderly population .


Midurethral slings have become the most preferred surgical treatment for female urinary incontinence .


To compare the efficacy and safety of two midurethral sling procedures with a different technique of sling insertion 5 yr after intervention .


Multicenter randomized clinical trial conducted in seven public hospitals in Finland including primary cases of stress urinary incontinence .


Surgical treatment with the retropubic tension-free vaginal tape ( TVT ) procedure or the transobturator tension-free vaginal tape ( TVT-O ) procedure .


Objective treatment success criteria were a negative stress test , a negative 24-h pad test , and no retreatment for stress incontinence .


Patient satisfaction was assessed by condition-specific quality-of-life questionnaires .


A total of 95 % of the included women could be assessed according to the protocol 5 yr after surgery .


The objective cure rate was 84.7 % in the TVT group and 86.2 % in the TVT-O group , with no statistical difference between the groups .


Subjective treatment satisfaction was 94.2 % in the TVT group and 91.7 % in the TVT-O group , with no difference between groups .


Complication rates were low , with no difference between groups .


Both objective and subjective cure rates were > 80 % in both groups even when women lost to follow-up were included as failures .


The complication rates were low , with no difference between the groups .


No late-onset adverse effects of the tape material were seen .


Female urinary stress incontinence can be treated surgically with minimally invasive midurethral sling procedures .


Two main approaches of sling placement have been developed : the retropubic and the transobturatory .


We compared both approaches and followed the patients for 5 yr .


We found no difference in cure rate between the procedures , and patient satisfaction was high .


ClinicalTrials.gov identifier NCT00379314 .


Telmisartan and atenolol are widely used in the management of essential hypertension .


This study was conducted to compare the efficacy of these two drugs in management of patients of essential hypertension .


Diagnosed patients of essential hypertension were selected .


Therapeutic option ( telmisartan/atenolol ) was allocated to the patients by lottery method and they were divided into two groups .


The patients were followed on subsequent visits ( 4 in total ) and their sitting systolic and diastolic blood pressures were recorded .


Total number of 180 patients were divided into two treatment groups ( i.e. , telmisaran and atenolol ) .


Forty percent were male and 60 % were female .


Majority of the patients were of age group 56-75 years .


Telmisartan reduced systolic and diastolic blood pressure significantly compared to atenolol at the end of 8 weeks of treatment ( p = 0.000 and 0.016 respectively ) .


Telmisartan 80 mg once daily is more effective than atenolol 50 mg once daily in lowering systolic and diastolic blood pressure at the end of 8 weeks of treatment .


To evaluate the effect of early enteral nutrition ( EEN ) on immune response and clinical outcomes after esophageal cancer operation .


Sixty patients with esophageal cancer undergoing radical operation between March 2010 and July 2011 were randomly divided into two groups using envelope method : EEN group ( n = 30 , administration of water and enteral nutrition early after operation ) and TPN group ( n = 30 , administration of total parenteral nutrition ) .


Two groups both received 7-day nutrition support .


Immune indexes ( CD3 ( + ) , CD4 ( + ) , CD8 ( + ) , CD4 ( + ) / CD8 ( + ) ) and serum nutritional indexes ( albumin , pre-albumin , transferrin ) were measured before operation and 1 - , 3 - , and 7-day after operation .


The time to first flatus , length of postoperative hospital stay , total hospitalization cost , and postoperative complication were recorded .


As compared to TPN group , the time to first flatus was significantly shorter in EEN group [ ( 66.57.3 ) h vs. ( 75.16.8 ) h , P < 0.01 ] , as was hospital stay [ ( 7.81.1 ) d vs. ( 9.31.3 ) d , P < 0.01 ] .


Total hospitalization cost [ ( 36 2103810 ) yuan vs. ( 39 7314013 ) yuan , P < 0.01 ] was lower in EEN group as compared to TPN group .


There was no significant difference in postoperative complication rate between the two groups [ 13.3 % ( 3/30 ) vs. 20.0 % ( 6/30 ) , P > 0.05 ] .


The levels of CD3 ( + ) , CD4 ( + ) , CD4 ( + ) / CD8 ( + ) , albumin , prealbumin and transferrin were significantly higher in EEN group as compared to TPN group on postoperative day 3 and 7 ( all P < 0.05 ) , while CD8 ( + ) was significantly lower in EEN group ( P < 0.05 ) .


EEN can promote early recovery of gastrointestinal function , improve nutritional and immune function , and therefore lead to fast postoperative recovery in esophageal cancer patients .


Dietary intake assessment with diet records ( DR ) is a standard research and practice tool in nutrition .


Manual entry and analysis of DR is time-consuming and expensive .


New electronic tools for diet entry by clients and research participants may reduce the cost and effort of nutrient intake estimation .


To determine the validity of electronic diet recording , we compared responses to 3-day DR kept by Tap & Track software for the Apple iPod Touch and records kept on the Nutrihand website to DR coded and analyzed by a research dietitian into a customized US Department of Agriculture ( USDA ) nutrient analysis program , entitled GRAND ( Grand Forks Research Analysis of Nutrient Data ) .


Adult participants ( n = 19 ) enrolled in a crossover-designed clinical trial .


During each of two washout periods , participants kept a written 3-day DR. In addition , they were randomly assigned to enter their DR in a Web-based dietary analysis program ( Nutrihand ) or a handheld electronic device ( Tap & Track ) .


They completed an additional 3-day DR and the alternate electronic diet recording methods during the second washout .


Entries resulted in 228 daily diet records or 12 for each of 19 participants .


Means of nutrient intake were calculated for each method .


Concordance of the intake estimates were determined by Bland-Altman plots .


Coefficients of determination ( R ( 2 ) ) were calculated for each comparison to assess the strength of the linear relationship between methods .


No significant differences were observed between the mean nutrient values for energy , carbohydrate , protein , fat , saturated fatty acids , total fiber , or sodium between the recorded DR analyzed in GRAND and either Nutrihand or Tap & Track , or for total sugars comparing GRAND and Tap & Track .


Reported values for total sugars were significantly reduced ( P < .05 ) comparing Nutrihand to GRAND .


Coefficients of determination ( R ( 2 ) ) for Nutrihand and Tap & Track compared to DR entries into GRAND , respectively , were energy .56 , .01 ; carbohydrate .58 , .08 ; total fiber .65 , .37 ; sugar .78 , .41 ; protein .44 , .03 ; fat .36 , .03 ; saturated fatty acids .23 , .03 ; sodium .20 , .00 ; and for Nutrihand only for cholesterol .88 ; vitamin A .02 ; vitamin C .37 ; calcium .05 ; and iron .77 .


Bland-Altman analysis demonstrates high variability in individual responses for both electronic capture programs with higher 95 % limits of agreement for dietary intake recorded on Tap & Track .


In comparison to dietitian-entered 3-day DR , electronic methods resulted in no significant difference in mean nutrient estimates but exhibited larger variability , particularly the Tap & Track program .


However , electronic DR provided mean estimates of energy , macronutrients , and some micronutrients , which approximated those of the dietitian-analyzed DR and may be appropriate for dietary monitoring of groups .


Electronic diet assessment methods have the potential to reduce the cost and burden of DR analysis for nutrition research and clinical practice .


Clinicaltrials.gov NCT01183520 ; http://clinicaltrials.gov/ct2/show/NCT01183520 ( Archived by WebCite at http://www.webcitation.org/6VSdYznKX ) .


To test in the primary care setting the short - and long-term efficacy of a behavioral intervention that simultaneously targeted an overweight child and parent versus an information control ( IC ) targeting weight control only in the child .


Two - to 5-year-old children who had BMI 85th percentile and an overweight parent ( BMI > 25 kg/m2 ) were randomized to Intervention or IC , both receiving diet and activity education over 12 months ( 13 sessions ) followed by 12-month follow-up ( 3 sessions ) .


Parents in the Intervention group were also targeted for weight control and received behavioral intervention .


Pediatricians in 4 practices enrolled their patients with the assistance of embedded recruiters ( Practice Enhancement Assistants ) who assisted with treatment too .


A total of 96 of the 105 children randomized ( Intervention n = 46 ; IC n = 50 ) started the program and had data at baseline .


Children in the Intervention experienced greater reductions in percent over BMI ( group months ; P = .002 ) and z-BMI ( group months ; P < 0.001 ) compared with IC throughout treatment and follow-up .


Greater BMI reduction was observed over time for parents in the Intervention compared with IC ( P < .001 ) throughout treatment and follow-up .


Child weight changes were correlated with parent weight changes at 12 and 24 months ( r = 0.38 and 0.26 ; P < .001 and P = .03 ) .


Concurrently targeting preschool-aged overweight and obese youth and their parents in primary care with behavioral intervention results in greater decreases in child percent over BMI , z-BMI , and parent BMI compared with IC .


The difference between Intervention and IC persists after 12 months of follow-up .