In case of superiority of the 10 mg prednisolone group versus the placebo group , the third step will be a non-inferiority test for the 10 mg prednisolone group versus the 60 mg prednisolone group ( = 0.025 ) .


The CORRA trial will yield information concerning the optimal glucocorticoid dosage schedule in the treatment of patients with early rheumatoid arthritis .


This trial was registered on 19 November 2013 at ClinicalTrials.gov .


NCT02000336 .


The aim of the current study was to investigate potential benefits of likelihood alarm systems ( LASs ) over binary alarm systems ( BASs ) in a multitask environment .


Several problems are associated with the use of BASs , because most of them generate high numbers of false alarms .


Operators lose trust in the systems and ignore alarms or cross-check all of them when other information is available .


The first behavior harms safety , whereas the latter one reduces productivity .


LASs represent an alternative , which is supposed to improve operators ' attention allocation .


We investigated LASs and BASs in a dual-task paradigm with and without the possibility to cross-check alerts with raw data information .


Participants ' trust in the system , their behavior , and their performance in the alert and the concurrent task were assessed .


Reported trust , compliance with alarms , and performance in the alert and the concurrent task were higher for the LAS than for the BAS .


The cross-check option led to an increase in alert task performance for both systems and a decrease in concurrent task performance for the BAS , which did not occur in the LAS condition .


LASs improve participants ' attention allocation between two different tasks and therefore lead to an increase in alert task and concurrent task performance .


The performance maximum is achieved when LAS is combined with a cross-check option for validating alerts with additional information .


The use of LASs instead of BASs in safety-related multitask environments has the potential to increase safety and productivity likewise .


Excessive body weight , low physical activity and excessive sedentary time in youth are major public health concerns .


A new generation of video games , the ones that require physical activity to play the games -- i.e. active games -- may be a promising alternative to traditional non-active games to promote physical activity and reduce sedentary behaviors in youth .


The aim of this manuscript is to describe the design of a study evaluating the effects of a family oriented active game intervention , incorporating several motivational elements , on anthropometrics and health behaviors in adolescents .


The study is a randomized controlled trial ( RCT ) , with non-active gaming adolescents aged 12-16 years old randomly allocated to a ten month intervention ( receiving active games , as well as an encouragement to play ) or a waiting-list control group ( receiving active games after the intervention period ) .


Primary outcomes are adolescents ' measured BMI-SDS ( SDS = adjusted for mean standard deviation score ) , waist circumference-SDS , hip circumference and sum of skinfolds .


Secondary outcomes are adolescents ' self-reported time spent playing active and non-active games , other sedentary activities and consumption of sugar-sweetened beverages .


In addition , a process evaluation is conducted , assessing the sustainability of the active games , enjoyment , perceived competence , perceived barriers for active game play , game context , injuries from active game play , activity replacement and intention to continue playing the active games .


This is the first adequately powered RCT including normal weight adolescents , evaluating a reasonably long period of provision of and exposure to active games .


Next , strong elements are the incorporating motivational elements for active game play and a comprehensive process evaluation .


This trial will provide evidence regarding the potential contribution of active games in prevention of excessive weight gain in adolescents .


Dutch Trial register NTR3228 .


Metabolic syndrome ( MetS ) is diagnosed by the detection of at least three criteria ( hypertriglyceridemia , low HDL-C , hypertension , obesity and altered fasting glucose ) .


Visceral fat excess would be the starting point for its development .


Scientific evidence supports hypocaloric diets - mediterranean or low fat diet and rich in complex carbohydrates diet included - as the best treatment to reduce fat mass ( FM ) , maximizing its impact by combining them with physical exercise ( PE ) .


However , the effects of these treatments on basal metabolic rate ( BMR ) of patients with MetS , are unknown .


To study the effect of the hypocaloric diet - mediterranean or low fat diet - with or without PE on the BMR and body composition ( BC ) of adults with MetS .


36 volunteers , MetS , both sexes , > 50 years , meeting the inclusion criteria .


They were randomly assigned to a group of intervention ( 3 months ) of hypocaloric diet : mediterranean diet ( MED ) , low fat and rich in complex carbohydrates diet ( CHO ) and both combined with PE ( MEDE and CHOE respectively ) .


Anthropometric data was taken ( weight , muscle mass ( MM ) and FM ) and BMR was determined by indirect calorimetry , before and after intervention .


The addition of PE to both hypocaloric treatments produced greater FM loss and weight loss than dieting alone , being this loss in CHOE > MEDE ( p < 0.05 ) .


These groups decreased the BMR after treatment being MEDE > CHOE ( p < 0.05 ) .


Mediterranean diet with or without PE lost MM ( p < 0.05 ) being MEDE > MED CONCLUSIONS : CHOE induces less reduction of BMR while supporting a better profile of BC than MEDE .


To determine the relation between thrombus aspiration ( TA ) and/or intra-lesion ( IL ) abciximab with pre-stent Thrombolysis In Myocardial Infarction ( TIMI ) flow grade and infarct size ( IS ) in patients with ST-elevation myocardial infarction ( STEMI ) undergoing primary percutaneous coronary intervention ( PCI ) .


The INFUSE-AMI trial randomised 452 patients with anterior STEMI to IL abciximab vs. no abciximab , and to manual TA vs. no TA .


The primary endpoint was cMRI-determined IS at 30 days .


Patients were classified according to pre-stent TIMI flow .


Complete data were available in 290 patients - 68 ( 25.2 % ) with pre-stent TIMI 0/1 flow , 47 ( 17.4 % ) with TIMI 2 flow and 175 ( 57.4 % ) with TIMI 3 flow .


Patients with pre-stent TIMI 3 flow had significantly lower IS ( 15.5 % [ 4.6 , 21.8 ] vs. 22.6 % [ 14.7 , 28.0 ] for TIMI 2 vs. 19.5 [ 14.4 , 27.8 ] for TIMI 0/1 , p < 0.0001 ) and fewer 30-day clinical events ( p = 0.03 ) .


Patients receiving TA with or without IL abciximab had the highest rate of pre-stent TIMI 3 flow ( p < 0.0001 ) and patients receiving both had the smallest IS ( 14.7 % vs. 17.3 % for the other three groups , p = 0.03 ) .


Optimisation of coronary flow prior to stent implantation may reduce infarct size and clinical events in STEMI patients undergoing primary PCI .


Type 2 diabetes mellitus ( T2DM ) is a metabolic disease with debilitating effects on multiple organs .


The alveolar-capillary network in the lung is a large microvascular unit which may be affected by T2DM-associated microangiopathy .


This retrospective study investigated whether type 2 diabetes mellitus ( T2DM ) affected pulmonary function .


Of the 584 patients enrolled in the study , 292 had T2DM and 292 did not .


Forced expiratory volume in one second ( FEV ) , forced vital capacity ( FVC ) , maximum voluntary ventilation ( MVV ) and total lung capacity ( TLC ) are values as percent of predicted , as well as FEV/FVC ratio which were values measured .


FEV , FVC , FEV/FVC ratio , MVV , and TLC were significantly lower in T2DM than in non-T2DM ( P-values < 0.010 ) .


Multiple linear regression analysis found that for the entire study population fasting plasma glucose levels was negatively associated with FEV , FVC , FEV/FVC ratio and maximum voluntary ventilation ( P-values < 0.030 ) .


Patients with T2DM were negatively associated with total lung capacity ( P-values = 0.025 ) .


Multiple linear regression analysis found for patients with T2DM that fasting plasma glucose was negatively associated with FEV , FVC , FEV/FVC ratio and maximum voluntary ventilation ( P-values < 0.020 ) .


In T2DM patient , height was negatively correlated with FEV and FVC ( all P-values < 0.020 ) , triglycerides were negatively correlated with FEV/FVC ratio ( P-values = 0.048 ) , and creatinine was negatively correlated with total lung capacity ( P-values = 0.017 ) .


In summary , T2DM is associated with impaired pulmonary function consistent with obstructive ventilation pattern and fasting plasma glucose is an independent risk factor of reduced pulmonary function .


The long-term outcome between laparoscopic cholecystectomy ( LC ) and minilaparotomy cholecystectomy ( MC ) with ultrasonic dissection ( UsD ) technique has not been compared in randomized trials .


Therefore , we investigated the outcome after conventional LC and MC with UsD in 78 patients ( ClinicalTrials.gov Identifier : NCT0172340 ) .


Initially 88 patients with non-complicated symptomatic gallstone disease were randomized into MC ( n = 44 ) or LC ( n = 44 ) over a period of 2 years ( 2010-2012 ) and 78 of them ( 89 % ) were reached for a follow-up interview at 12 months after the surgery .


Baseline parameters were similar in the two groups , and 1/44 MCs and 2/44 LCs were converted to open laparotomy .


The prevalence of chronic post-surgical pain ( CPSP ) one year after the procedure was quite similar in the two groups : 3/36 ( 8 % ) in the MC group and 2/42 ( 5 % ) in the LC group ( p = 0.502 ) .


Residual abdominal symptoms were common , but the proportion was similar in both groups ( 28 % in MC and 33 % in LC group , p = 0.665 ) .


Both groups were very satisfied with the cosmetic outcome ( numeric rating scale , p = 0.470 ) .


The Quality of life ( QoL ) improved 34/36 ( 94 % ) in the MC group and 33/42 ( 79 % ) in the LC group ( p = 0.046 ) and all patients in both groups were satisfied with the operation overall .


Day-case MC and LC patients have a quite similar one-year outcome with no significant difference regarding residual abdominal symptoms , cosmetic satisfaction , QoL or CPSP .


To describe the variation in household crowding and social mixing patterns in the African meningitis belt and to assess any association with self-reported recent respiratory symptoms .


In 2010 , the African Meningococcal Carriage Consortium ( MenAfriCar ) conducted cross-sectional surveys in urban and rural areas of seven countries .


The number of household members , rooms per household , attendance at social gatherings and meeting places were recorded .


Associations with self-reported recent respiratory symptoms were analysed by univariate and multivariate regression models .


The geometric mean people per room ranged from 1.9 to 2.8 between Ghana and Ethiopia respectively .


Attendance at different types of social gatherings was variable by country , ranging from 0.5 to 1.5 per week .


Those who attended 3 or more different types of social gatherings a week ( frequent mixers ) were more likely to be older , male ( OR 1.27 , p < 0.001 ) and live in urban areas ( OR 1.45 , p < 0.001 ) .


Frequent mixing and young age , but not increased household crowding , were associated with higher odds of self-reported respiratory symptoms ( aOR 2.2 , p < 0.001 and OR 2.8 , p < 0.001 respectively ) .


A limitation is that we did not measure school and workplace attendance .


There are substantial variations in household crowding and social mixing patterns across the African meningitis belt .


This study finds a clear association between age , increased social mixing and respiratory symptoms .


It lays the foundation for designing and implementing more detailed studies of social contact patterns in this region .


It has been reported that even oneyear after total knee arthroplasty ( TKA ) , a relevant percentage of patients does not attain complete recovery and indicate unfavourable long-term pain outcome .


We compared the clinical outcome of 33 patients undergoing TKA randomly assigned to the control or the pulsed electromagnetic field group ( I-ONE therapy ) .


I-ONE therapy was administered postoperatively four hours per day for 60days .


Patients were assessed before surgery and then at one , two and sixmonths postoperatively using international scores .


One month after TKA , pain , knee swelling and functional score were significantly better in the treated compared with the control group .


Pain was still significantly lower in the treated group at the six month follow-up .


Three years after surgery , severe pain and occasional walking limitations were reported in a significantly lower number of patients in the treated group .


Advantages deriving from early control of joint inflammation may explain the maintenance of results at follow-up .


I-ONE therapy should be considered an effective completion of the TKA procedure .


The objective of this study was to compare the perfusion index ( PI ) variability in premature infants with respiratory distress syndrome ( RDS ) following administration of two different natural surfactant preparations .


This was a prospective study on 92 preterm infants with RDS .


Patients were randomized into two groups .


Group 1 ( n = 46 ) received beractant ; Group 2 ( n = 46 ) received poractant alfa .


Oxygen saturation , PI , and heart rate were measured by Masimo Rainbow SET Radical-7 pulse oximeter ( Masimo Corp. , Irvine , CA ) before and after surfactant .


The effects of the two treatment regimens on PI and oxygenation were compared .


Repeated doses were more needed in beractant group ( p = 0.04 ) .


Median oxygenation index ( OI ) before surfactant were similar , but improvement in OI was more prominent at 6th hour of surfactant in Group 2 ( p = 0.001 ) .


Both groups had similar preductal PI values before surfactant .


PI was higher at 6th hour of surfactant in Group 2 ( p = 0.001 ) .


Pulmonary hemorrhage , intraventricular hemorrhage , patent ductus arteriosus , necrotizing enterocolitis , and mortality were more frequent in infants whose PI values lower than 0.7 within the first 5 days of life ( p = 0.001 ) .


Poractant alfa resulted in more prominent improvement in PI and OI .


Low PI values measured at early postnatal period may predict poor clinical outcome in preterm infants with RDS .


Atopic dermatitis ( atopic eczema ) is a chronic inflammatory skin disease that has reached epidemic proportions in children worldwide and is increasing in prevalence .


Because of the significant socioeconomic effect of atopic dermatitis and its effect on the quality of life of children and families , there have been decades of research focused on disease prevention , with limited success .


Recent advances in cutaneous biology suggest skin barrier defects might be key initiators of atopic dermatitis and possibly allergic sensitization .


Our objective was to test whether skin barrier enhancement from birth represents a feasible strategy for reducing the incidence of atopic dermatitis in high-risk neonates .


We performed a randomized controlled trial in the United States and United Kingdom of 124 neonates at high risk for atopic dermatitis .


Parents in the intervention arm were instructed to apply full-body emollient therapy at least once per day starting within 3 weeks of birth .


Parents in the control arm were asked to use no emollients .


The primary feasibility outcome was the percentage of families willing to be randomized .


The primary clinical outcome was the cumulative incidence of atopic dermatitis at 6 months , as assessed by a trained investigator .


Forty-two percent of eligible families agreed to be randomized into the trial .


All participating families in the intervention arm found the intervention acceptable .


A statistically significant protective effect was found with the use of daily emollient on the cumulative incidence of atopic dermatitis with a relative risk reduction of 50 % ( relative risk , 0.50 ; 95 % CI , 0.28-0 .9 ; P = .017 ) .


There were no emollient-related adverse events and no differences in adverse events between groups .


The results of this trial demonstrate that emollient therapy from birth represents a feasible , safe , and effective approach for atopic dermatitis prevention .


If confirmed in larger trials , emollient therapy from birth would be a simple and low-cost intervention that could reduce the global burden of allergic diseases .


Fluralaner , a new molecular entity of the isoxazoline class , has potent insecticidal and acaricidal activity and can be safely administered orally to dogs .


A randomized , investigator-blinded , multi-centered field study compared the flea - and tick-control efficacy for dogs over a 12-week period with either a single oral dose of Bravecto ( fluralaner ) formulated as a chewable tablet or with three sequential topical Frontline ( fipronil ) treatments .


Individual dogs were the experimental unit for ticks and households were the experimental unit for fleas .


A total of 108 tick-infested dogs were treated with Bravecto ( fluralaner ) and 54 tick-infested dogs were treated with Frontline ( fipronil ) .


Dogs in 115 flea-infested households received Bravecto ( fluralaner ) and dogs in 61 flea-infested households received Frontline ( fipronil ) .


Flea and tick counts were conducted on all dogs at weeks 2 , 4 , 8 , and 12 following initial treatment and efficacy was calculated as the mean percent reduction in tick or flea count at each time point compared with the mean pretreatment initiation count for each treatment group .


Additionally , the percentages of tick-free and flea-free households were determined .


At weeks 2 , 4 , 8 , and 12 , Bravecto ( fluralaner ) flea-control efficacy in treated households was 99.2 % , 99.8 % , 99.8 % , and 99.9 % respectively , while Frontline ( fipronil ) efficacy was 94.1 % , 93.0 % , 96.0 % , and 97.3 % , respectively .


Bravecto ( fluralaner ) tick-control efficacy on treated dogs at weeks 2 , 4 , 8 , and 12 was 99.9 % , 99.9 % , 99.7 % , and 100 % , respectively , and Frontline ( fipronil ) tick efficacy was 97.6 % , 93.8 % , 100 % , and 100 % , respectively .


Of dogs showing clinical flea allergy dermatitis ( FAD ) signs at the study start , 85.7 % in the Bravecto ( fluralaner ) - treated group and 55.6 % in the Frontline ( fipronil ) - treated group were evaluated at each time point as showing no clinical signs of FAD until study completion .


Bravecto ( fluralaner ) administered once orally to dogs in a chewable tablet was highly effective for 12 weeks against fleas and ticks on privately-owned dogs and was significantly non-inferior ( ticks ) and superior ( fleas ) in comparison with topical Frontline ( fipronil ) administered 3 times sequentially .


Cocaine has become one of the drugs of most concern in Switzerland , being associated with a wide range of medical , psychiatric and social problems .


Available treatment options for cocaine dependence are rare .


The study sought to compare combined prize-based contingency management ( prizeCM ) plus cognitive-behavioral therapy ( CBT ) to CBT alone in cocaine-dependent patients .


Sixty cocaine-dependent patients participated in a randomized , controlled trial with two treatment conditions .


The participants were randomly assigned to the experimental group ( EG ; n = 29 ) , who received CBT combined with prizeCM , or to the control group ( CG ; n = 31 ) , who received CBT only during 24 weeks .


The primary outcome measures were retention , at least 3 consecutive weeks of cocaine abstinence , the maximum number of consecutive weeks of abstinence and proportions of cocaine-free urine samples during the entire 24-week and at 6-month follow-up .


Sixty-three percent of the participants completed the study protocol .


Participants in both groups significantly reduced cocaine use over time .


Overall , no difference in cocaine-free urine screens was found across the two treatment groups , except at weeks 8 , 9 , 10 , 17 and 21 in favor of the EG .


The addition of prizeCM to CBT seems to enhance treatment effects , especially in the early treatment period , supporting results from previous studies .


Both the combined intervention and CBT alone , led to significant reductions in cocaine use during treatment and these effects were sustained at 6-month follow-up .


These findings underline the importance in implementing CM and CBT interventions as treatment options for cocaine dependence in the European context .


Integrated vector management strategies depend on local eco-bio-social conditions , community participation , political will and inter-sectorial partnership .


Previously identified risk factors for persistent Triatoma dimidiata infestation include the presence of rodents and chickens , tiled roofs , dirt floors , partial wall plastering and dog density .


A community-based intervention was developed and implemented based on cyclical stakeholder and situational analyses .


Intervention implementation and evaluation combined participatory action research and cluster randomized pre-test post-test experimental designs .


The intervention included modified insecticide application , education regarding Chagas disease and risk factors , and participatory rodent control .


At final evaluation there was no significant difference in post-test triatomine infestation between intervention and control , keeping pre-test rodent and triatomine infestations constant .


Knowledge levels regarding Chagas disease and prevention practices including rodent control , chicken management and health service access increased significantly only in intervention communities .


The odds of nymph infection and rat infestation were 8.3 and 1.9-fold higher in control compared to intervention communities , respectively .


Vector control measures without reservoir control are insufficient to reduce transmission risk in areas with persistent triatomine infestation .


This integrated vector management program can complement house improvement initiatives by prioritizing households with risk factors such as tiled roofs .


Requirement for active participation and multi-sectorial coordination poses implementation challenges .


To examine whether Modic changes influence pain during a 1-year follow-up in patients with lumbar radicular pain .


A total of 243 patients with lumbar radicular pain due to disc herniation were recruited from two hospitals in Norway and followed up at 6 weeks , 6 months , and 12 months .


On baseline lumbar magnetic resonance images , two observers independently evaluated Modic changes ( types I-III ; craniocaudal size 0-3 ) .


Outcomes were sensory pain ( McGill Pain Questionnaire ) , back and leg pain ( visual analogue scale , VAS ) .


Association between Modic type and outcomes was explored with a mixed model and then by two-way analysis of variance ( ANOVA ) at each time point with Modic and treatment groups ( surgical , n = 126 ; nonsurgical , n = 117 ) as fixed factors , adjusted for disc degeneration , age , sex , smoking , and duration of radicular pain .


Modic size was also analyzed using ANOVA .


Pain scores had decreased significantly at 1-year follow-up .


Modic type was significantly related to McGill sensory scores ( mixed model : p = 0.014-0 .026 ; ANOVA : p = 0.007 at 6 weeks ) , but not to VAS back pain or VAS leg pain scores .


At 6 weeks , the mean McGill sensory score was higher in Modic I than in Modic II-III patients ( p = 0.003 ) and in patients without Modic changes ( p = 0.018 ) .


Modic size L1-S1 was not associated with pain outcomes .


Patients with lumbar radicular pain have a substantial pain reduction during 1-year follow-up , but Modic type I changes may imply a slower initial decrease in sensory pain .


This cross-sectional study tested the hypothesis that treatment with the combination of Ezetimibe/Simvastatin ( Vytorin ) leads to broader changes in the expression levels of immunomodulatory genes as compared to Simvastatin monotherapy .


Illumina 's GenomeStudio gene expression module was used to compare gene profiles of Vytorin and Simvastatin in the peripheral blood mononuclear cells of 20 hypercholesterolemic subjects .


The characteristics of the immunomodulatory genes , which were altered by Vytorin , differed from those genes which were altered by Simvastatin .


Vytorin mostly altered the expression levels of genes related to inflammation/oxidative stress ; it downregulated the NF-KappaB and upregulated the expression of anti-inflammatory cytokine , IL-10 , and anti-oxidant enzymes , GPX1 and SOD2 , but also upregulated the expression levels of genes involved in cellular activation , adhesion , and coagulation cascade , including VWF , F7 , PF4 , PF4V1 SELP , ITGB3 , ITGB5 .


Simvastatin mostly altered the expression levels of genes related to cellular apoptosis/proliferation .


It upregulated the expression levels of apoptosis-related genes APAF1 , BAX , IER3 , and CSF1R , and downregulated the expression levels of genes related to cellular proliferation , including PTN and CD69 .


Treatment with Vytorin combination therapy modulated lipid profile and serum levels of the C-reactive protein more effectively , than treatment with Simvastatin monotherapy .


The nature of the pleiotropic effects may play a role in Vytorin 's and Simvastatin 's clinical efficacies .


The presence of hyponatremia has been perceived to increase the risk of adverse events on initiation of treatment with angiotensin-converting enzyme inhibition in heart failure patients .


The aim of this study was to investigate if baseline hyponatremia ( plasma Na ( + ) < 135mmol/L ) predicts development of hypotension and renal impairment in patients with myocardial infarction ( MI ) and left ventricular dysfunction ( LVD ) treated with angiotensin-converting enzyme inhibitors .


A retrospective analysis was performed with data from the Trandolapril Cardiac Evaluation ( TRACE ) a double-blind randomized study .


Plasma sodium levels were available in 1,731 patients , who were considered as the study population .


Patients 3-7days after MI with left LVD ( LVEF 0.35 ) , were randomized to trandolapril ( n = 876 ) or placebo ( n = 873 ) .


Baseline hyponatremia did not predict development of hypotension or worsening renal function after 1month in patients treated with trandolapril compared with placebo ( 12219.1 mm Hg vs 123.220.4 mm Hg [ P = .84 ] ; and creatinine clearance 57.421.4 mL/min vs 55.221.0 mL/min [ P = .8 ] ) .


There was no interaction between hyponatremia and the effect of trandolapril ( P = .68 ) .


Mild hyponatremia was not a contraindication for the initiation of treatment with angiotensin-converting enzyme inhibitors in patients with post-MI heart failure .


Psoriasis is a chronic inflammatory dermatosis leading to the development of systemic inflammatory reaction .


Previous data indicated the coexistence of psoriasis and the occurrence of metabolic disorders , with the common background of both processes determined by a chronic inflammation .


The coexisting disorders , including type 2 diabetes , hypertension , heart ischemic disease , dislipidemia and obesity may have an important impact on intensity of psoriasis activity .


The analysis comprised of 82 randomly matched patients with various clinical forms of psoriasis , aged 17 to 81 years .


In patients PASI and BSA indexes , BMI value and laboratory parameters of metabolic status ( glucose and ureic acid levels , lipid fractions and CRP level in the serum ) were evaluated .


An average age in examined group was 54,3 years , an average time of presence of psoriasis symptoms was approximately 20 years .


An average PASI value was 21,4 ; an average BSA value was 39.7 % .


The coexistence of type 2 diabetes was found in 14.6 % of patients , hypertension in 42.7 % and heart ischemic disease in 17 % .


Particularly large group of examined patients comprised persons with overweight ( 34.1 % ) and obesity ( 30.5 % ) .


Positive correlation between BSA and body weight , BSA and BMI value , BSA and abdominal circumference as well as positive correlation between PASI and body weight , PASI and BMI value , PASI and abdominal circumference were observed .


Abnormal serum glucose levels were observed in 19.5 % persons , ureic acid level in 2.9 % , total cholesterol in 37.8 % LDL cholesterol in 48.8 % , and HDL cholesterol in 46.3 % .


CRP level was elevated in 43.9 % patients .


Positive correlation between BSA and ureic acid level , as well as PASI and ureic acid level was estimated .


No correlation between PASI and the other laboratory parameters was found .


The occurrence of metabolic syndrome is more common in patients with psoriasis in comparison to the general population .


The extent and severity of psoriatic lesions correlate with high body weight , BMI and the level of ureic acid .


Although exhaled breath condensate ( EBC ) pH has been identified as an `` emerging '' biomarker of interest for asthma clinical trials , the clinical determinants of EBC pH remain poorly understood .


Other studies have associated acid reflux-induced respiratory symptoms , for example , cough , with transient acidification of EBC .


We sought to determine the clinical and physiologic correlates of EBC acidification in a highly characterized sample of children with poorly controlled asthma .


We hypothesized that ( 1 ) children with asymptomatic gastroesophageal reflux determined by 24-hour esophageal pH monitoring would have a lower EBC pH than children without gastroesophageal reflux , ( 2 ) treatment with lansoprazole would alter EBC pH in those children , and ( 3 ) EBC acidification would be associated with increased asthma symptoms , poorer asthma control and quality of life , and increased formation of breath nitrogen oxides ( NOx ) .


A total of 110 children , age range 6 to 17 years , with poor asthma control and esophageal pH data enrolled in the Study of Acid Reflux in Children with Asthma ( NCT00442013 ) were included .


Children submitted EBC samples for pH and NOx measurement at randomization and at study weeks 8 , 16 , and 24 .


Serial EBC pH measurements failed to distinguish asymptomatic gastroesophageal reflux and was not associated with breath NOx formation .


EBC pH also did not discriminate asthma characteristics such as medication and health care utilization , pulmonary function , and asthma control and quality of life both at baseline and across the study period .


Despite the relative ease of EBC collection , EBC pH as a biomarker does not provide useful information of children with asthma who were enrolled in asthma clinical trials .


No therapy directed against diabetes has been shown to unequivocally reduce the excess risk of cardiovascular complications .


Aleglitazar is a dual agonist of peroxisome proliferator-activated receptors with insulin-sensitizing and glucose-lowering actions and favorable effects on lipid profiles .


To determine whether the addition of aleglitazar to standard medical therapy reduces cardiovascular morbidity and mortality among patients with type 2 diabetes mellitus and a recent acute coronary syndrome ( ACS ) .


AleCardio was a phase 3 , multicenter , randomized , double-blind , placebo-controlled trial conducted in 720 hospitals in 26 countries throughout North America , Latin America , Europe , and Asia-Pacific regions .


The enrollment of 7226 patients hospitalized for ACS ( myocardial infarction or unstable angina ) with type 2 diabetes occurred between February 2010 and May 2012 ; treatment was planned to continue until patients were followed-up for at least 2.5 years and 950 primary end point events were positively adjudicated .


Randomized in a 1:1 ratio to receive aleglitazar 150 g or placebo daily .


The primary efficacy end point was time to cardiovascular death , nonfatal myocardial infarction , or nonfatal stroke .


Principal safety end points were hospitalization due to heart failure and changes in renal function .


The trial was terminated on July 2 , 2013 , after a median follow-up of 104 weeks , upon recommendation of the data and safety monitoring board due to futility for efficacy at an unplanned interim analysis and increased rates of safety end points .


A total of 3.1 % of patients were lost to follow-up and 3.2 % of patients withdrew consent .


The primary end point occurred in 344 patients ( 9.5 % ) in the aleglitazar group and 360 patients ( 10.0 % ) in the placebo group ( hazard ratio , 0.96 [ 95 % CI , 0.83-1 .11 ] ; P = .57 ) .


Rates of serious adverse events , including heart failure ( 3.4 % for aleglitazar vs 2.8 % for placebo , P = .14 ) , gastrointestinal hemorrhages ( 2.4 % for aleglitazar vs 1.7 % for placebo , P = .03 ) , and renal dysfunction ( 7.4 % for aleglitazar vs 2.7 % for placebo , P < .001 ) were increased .


Among patients with type 2 diabetes and recent ACS , use of aleglitazar did not reduce the risk of cardiovascular outcomes .


These findings do not support the use of aleglitazar in this setting with a goal of reducing cardiovascular risk .


clinicaltrials.gov Identifier : NCT01042769 .


Pressure ulcers ( PrUs ) are ischemic wounds in the skin and underlying tissues caused by long-standing pressure force over an external bone or cartilaginous surface .


PrUs are an important challenge for the overall health system because can prolong patient hospitalization and reduce quality of life .


Moreover , 95 % of PrUs are avoidable , suggesting they are caused by poor quality care assistance .


PrUs are also costly , increasing national costs .


For example , they represent about 5 % of overall annual health expenses in Spain .


Stages I and II PrUs have a combined prevalence of 65 % .


According main clinical guidelines , stage II PrUs ( PrU-IIs ) are usually treated by applying special dressings ( polyurethane or hydrocolloid ) .


However , little scientific evidence regarding their efficacy has been identified in scientific literature .


Our aim is to assess the comparative efficacy of adhesive polyurethane foam and hydrocolloid dressings in the treatment of PrU-IIs in terms of healed ulcer after 8 weeks of follow-up .


This paper describes the development and evaluation protocol of a randomized clinical trial of two parallel treatment arms .


A total of 820 patients with at least 1 PrU-II will be recruited from primary health care and home care centers .


All patients will receive standardized healing procedures and preventive measures ( e.g. positional changes and pressure-relieving support surfaces ) , following standardized procedures .


The main outcome will be the percentage of wounds healed after 8 weeks .


Secondary outcomes will include cost-effectiveness , as evaluated by cost per healed ulcer and cost per treated patient and safety evaluated by adverse events .


This trial will address the hypothesis that hydrocolloid dressings will heal at least 10 % more stage II PrUs and be more cost-effective than polyurethane foam dressings after 8 weeks .


This trial has been registered with controlled-trials number ISCRCTN57842461 and EudraCT 2012-003945-14 .


Despite the widespread use of external ventricular drainage , revision rates , and associated complications are reported between 10 and 40 % .


Current available image-guided techniques using stereotaxy , endoscopy , or ultrasound for catheter placements remain time-consuming techniques .


Recently , a smartphone-assisted guide with high precision has been described .


The development of an easy-to-use , portable , image-guided system could reduce the need for multiple passes and improve the rate of accurate catheter placement .


This study aims to prospectively compare in a randomized controlled manner the accuracy of the freehand pass technique versus an easy-to-use , portable , adjustable guiding device for ventriculostomy catheter placement .


This is a single center , prospective , randomized trial with a blinded endpoint ( ventricular catheter tip location ) assessment .


Adult patients with the indication for ventriculostomy , as proven by computed tomography ( CT ) , will be randomly assigned to the treatment group or the control group .


For patients in the treatment group , ventriculostomy will be performed using an adjustable guiding device and DICOM ( Digital Imaging and Communications in Medicine ) image-reading software assistance ( for example , using a mini-tablet ) based on preoperative CT imaging.Patients in the control group will receive standard freehand ventriculostomy using anatomical landmarks .


The catheter may be placed for external drainage or internal ( ventriculoperitoneal ) shunting in both groups .


The primary outcome measure is the rate of correct placements of the ventricular catheter , defined as a score of 1 to 3 on grading system for catheter tip location on a postoperative CT scan .


Participants will be followed for the duration of hospital stay , an expected average of two weeks .


The primary outcome will be determined by one of the authors blinded to the treatment allocation .


We aim to include 236 patients in three years .


Secondary outcome measures include : frequency of placements required , frequency of completed placements within the ventricle of the perforated part of the catheter tip , frequency of very early and early shunt failures ( revision of the ventricular drainage within 24 hours and within the hospital stay ) , frequency and percentage of complications ( procedure-related and nonsurgical ) at discharge .


This is the study design of a single center , prospective , randomized controlled trial to investigate whether guided ventriculostomy is superior to the standard freehand technique .


One strength of this study is the prospective , randomized , interventional type of study testing a new easy-to-handle guided versus freehand ventricular catheter placement .


A second strength of this study is that the power calculation is based on catheter accuracy using an available grading system for catheter tip location , and is calculated with the use of recent study results of our own population , supported by data from prominent studies .


Clinicaltrials.gov identifier : NCT02048553 ( registered on 28 January 2014 ) .


To compare visual acuity with two visual acuity charts in preschool children .


Visual acuity measurement with Lea symbols and Bailey-Lovie tumbling E chart was performed on children between 3 and 6 years of age .


Visual acuity data from the two charts were analyzed with Bland-Altman plot to determine the limits of agreement .


The Wilcoxon signed test was performed in children aged 3-4 years and in children aged 5-6 years separately to evaluate the influence of age .


The inter-eye difference between the two charts were further analyzed with the paired t-test .


A p value > 0.05 was considered statistically significant .


A total of 47 children were enrolled for the study .


The average logarithm of the Minimum Angle of Resolution ( LogMAR ) monocular visual acuity with Lea symbols ( 0.17 0.13 ) was better than the Bailey-Lovie tumbling E chart ( 0.22 0.14 ) .


The mean difference between Bailey-Lovie tumbling E chart and Lea symbol chart was 0.05 0.12 in logMAR units .


A second analysis eliminating outliers showed the same result but lower differences ( n = 43 , 0.05 0.05 logMAR units ) .


Visual acuity results between the two charts in children aged 3-4 years showed a significant difference ( p = 0.000 ) , but not for children aged 5-6 years ( p = 0.059 ) .


Inter-eye differences between the two charts was not statistically significant ( p = 0.77 ) .


Bailey-Lovie tumbling E chart is comparable to the Lea symbols chart in pre-school children .


But preference should be given to Lea symbols for children aged 3-4 years as the symbols are more familiar than a directional test for this age group .


Local analgesic injections are commonly used for pain relief after shoulder surgery .


The aim of this study was to compare the efficacy of local injections administered in the glenohumeral joint , the subacromial space , or both locations after arthroscopic rotator cuff repair .


Between March 2011 and December 2011 , 121 consecutive patients who had undergone arthroscopic rotator cuff repair surgery were enrolled in the study and all patients were randomly allocated to 3 groups .


In group 1 , 40 patients received a postoperative glenohumeral injection of bupivacaine ( 20mL ) and lidocaine ( 10mL ) .


In group 2 , 42 patients received the same postoperative injection , but it was administered in the subacromial space .


In group 3 , 39 patients received the same amount of local anesthesia but with half injected in the glenohumeral joint and half in the subacromial space .


The visual analog scale was used to assess pain intensity before surgery and at postoperative hours 1 , 2 , 6 , 12 , and 24 .


Demerol was used as a postinjection rescue analgesic , and the total number of administrations was recorded at each time point .


There were no significant differences between groups in patient age , sex , or rotator cuff tear size ( P > .05 ) .


The visual analog scale scores for pain between each group were not significantly different at any time point , including before surgery ( P > .05 ) .


In addition , the amount of supplementary analgesic administered was not significantly different between the groups ( P > .05 ) .


Injection of local analgesics after arthroscopic rotator cuff repair relieves postoperative pain regardless of the injection location .


To assess the efficacy and safety of early , noninvasive inhaled nitric oxide ( iNO ) therapy in premature newborns who do not require mechanical ventilation .


We performed a multicenter randomized trial including 124 premature newborns who required noninvasive supplemental oxygen within the first 72 hours after birth .


Newborns were stratified into 3 different groups by birth weight ( 500-749 , 750-999 , 1000-1250 g ) prior to randomization to iNO ( 10 ppm ) or placebo gas ( controls ) until 30 weeks postmenstrual age .


The primary outcome was a composite of death or bronchopulmonary dysplasia ( BPD ) at 36 weeks postmenstrual age .


Secondary outcomes included the need for and duration of mechanical ventilation , severity of BPD , and safety outcomes .


There was no difference in the incidence of death or BPD in the iNO and placebo groups ( 42 % vs 40 % , P = .86 , relative risk = 1.06 , 0.7-1 .6 ) .


BPD severity was not different between the treatment groups .


There were no differences between the groups in the need for mechanical ventilation ( 22 % vs 23 % ; P = .89 ) , duration of mechanical ventilation ( 9.7 vs 8.4 days ; P = .27 ) , or safety outcomes including severe intracranial hemorrhage ( 3.4 % vs 6.2 % , P = .68 ) .


We found that iNO delivered noninvasively to premature infants who have not progressed to early respiratory failure is a safe treatment , but does not decrease the incidence or severity of BPD , reduce the need for mechanical ventilation , or alter the clinical course .


Foods that are high in dietary fiber can promote satiety , but previous studies report conflicting results .


The objective was to determine differences in satiety response to three conditions ( 10g oat bran , 10g barley bran and a low fiber condition ) consumed at dinner and breakfast .


In addition , we compared energy intake at an ad libitum lunch after consumption of the breakfast bars .


Randomized , double-blind crossover study .


42 normal weight women .


Women consumed a dinner food bar from one of the three conditions the evening before testing .


On test mornings , fasted women consumed the corresponding breakfast food bar with their choice of coffee , tea or water .


An ad libitum pizza lunch was served 4 hours after breakfast .


Visual analogue scales ( VAS ) were used to assess satiety at baseline , 15 , 30 , 45 , 60 , 90 , 120 , 180 and 240 minutes .


Energy intake was assessed by an ad libitum pizza lunch ( 4 hours after breakfast ) and 24-hour energy intake was measured by a food diary .


Treatments were compared using the mixed-effects linear models .


Outcomes are reported as mean SEM .


There were no significant differences among conditions on any of the satiety scales and no significant differences among conditions in energy consumed at lunch or over 24 hours .


The fiber bars were well tolerated and no significant differences were found for gastrointestinal tolerance .


Our results do not support an effect of bran fibers on satiety above a low fiber control .


We acknowledge results of this study may be intricately tied to the choice of a single pizza lunch , as other ad libitum meal options could have resulted in different outcomes .


The -1 receptor ( Sig-1R ) agonist cutamesine ( SA4503 ) enhanced functional recovery after experimental stroke with a treatment initiation window of 48 hours and chronic treatment for 28 days .


We conducted a phase 2 clinical trial exploring the safety , tolerability , dose range , and functional effects of cutamesine in patients with ischemic stroke .


Subjects were randomized between 48 and 72 hours after stroke to receive cutamesine 1 mg/d , 3 mg/d , or placebo for 28 days .


Effects on safety and function were assessed at baseline , at end of treatment ( day 28 ) , and at end of follow-up ( day 56 ) .


In 60 patients , treatment with both cutamesine dosages was safe and well tolerated without significant differences in numbers of treatment emergent or serious adverse events .


No significant effect was observed on the primary efficacy measure ( change in National Institutes of Health Stroke Scale from baseline to day 56 ) or modified Rankin Scale and Barthel Index scores .


Post hoc analysis of moderately and severely affected patients ( baseline National Institutes of Health Stroke Scale , 7 and 10 ) showed greater National Institutes of Health Stroke Scale improvements in the 3 mg/d cutamesine group when compared with placebo ( P = 0.034 and P = 0.038 , respectively ) .


A trend toward a higher proportion being able to complete a 10m timed walk was observed for cutamesine-treated subjects .


Cutamesine was safe and well tolerated at both dosage levels .


Although no significant effects on functional end points were seen in the population as a whole , greater improvement in National Institutes of Health Stroke Scale scores among patients with greater pretreatment deficits seen in post hoc analysis warrants further investigation .


Additional studies should focus on the patient population with moderate-to-severe stroke .


http://www.clinicaltrials.gov/show/NCT00639249 .


Unique identifier : NCT00639249 .


The EudraCT number is 2007-004840-60 ( https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-004840-60/GB ) .


Frailty is a major concern due to its costly and widespread consequences , yet evidence of effective interventions to delay or reduce frailty is lacking .


Our previous study found that a multifactorial intervention was feasible and effective in reducing frailty in older people who were already frail .


Identifying and treating people in the pre-frail state may be an effective means to prevent or delay frailty .


This study describes a randomised controlled trial that aims to evaluate the effectiveness of a multifactorial intervention on development of frailty in older people who are pre-frail .


A single centre randomised controlled trial with concealed allocation , assessor blinding and intention-to-treat analysis .


Two hundred and thirty people aged above 70 who meet the Cardiovascular Health Study frailty criteria for pre-frailty , reside in the community and are without severe cognitive impairment will be recruited .


Participants will be randomised to receive a multifactorial intervention or usual care .


The intervention group will receive a 12-month interdisciplinary intervention targeting identified characteristics of frailty and problems identified during geriatric assessment .


Participants will be followed for a 12-month period .


Primary outcome measures will be degree of frailty measured by the number of Cardiovascular Health Study frailty criteria present , and mobility measured with the Short Physical Performance Battery .


Secondary outcomes will include measures of mobility , mood and use of health and community services .


The study was approved by the Northern Sydney Local Health District Health Research Ethics Committee ( 1207-213M ) .


The findings will be disseminated through scientific and professional conferences , and in peer-reviewed journals .


Australian New Zealand Clinical Trials Registry : ACTRN12613000043730 .


To assess the effect of aerobic exercise training on maternal and neonatal outcome


The case-control study was conducted between January and July , 2011 .


It was approved by the Research Ethics Committee of Toyserkan Azad University , and data was collected at prenatal clinics and delivery centres located in Hamedan , Iran .


It comprised 80 pregnant women between 20-26 weeks of gestation randomly assigned to two equal and matching groups of cases and controls .


The intervention group did exercise continuously on a bicycle ergometre for 15 minutes , three times a week ; the intensity being 50-60 % of maximal heart rate .


The control group did not do any exercise training .


All information was obtained from the clinics , delivery centres , and from the reports of delivery room midwives .


No statistically significant difference was found between the two groups in gestational weight gain , pregnancy length , mode of delivery , first and second stage of labour , perineal tear , and 1st and 5th min Apgar score .


Mean neonatal weight was significantly less in the intervention group than the control group ( p < 0.001 ) .


Exercising on a bicycle ergometer during pregnancy seems to be safe for the mother and the neonate .


To determine patient independency , health-related and disease-specific quality of life ( QOL ) , gait pattern , and muscle strength in patients after salvage arthroplasty for failed internal fixation of a femoral neck fracture .


Secondary cohort study to a randomized controlled trial .


Multicenter trial in the Netherlands , including 14 academic and nonacademic hospitals .


Patients after salvage arthroplasty for failed internal fixation of a femoral neck fracture were studied .


A comparison was made with patients who healed uneventfully after internal fixation .


None ( observatory study ) .


Patient characteristics , SF-12 , and Western Ontario McMaster osteoarthritis index scores were collected .


Gait parameters were measured using plantar pressure measurement .


Maximum isometric forces of the hip muscles were measured using a handheld dynamometer .


Differences between the fractured and contralateral leg were calculated .


Groups were compared using univariate analysis .


Of 248 internal fixation patients ( median age , 72 years ) , salvage arthroplasty was performed in 68 patients ( 27 % ) .


Salvage arthroplasty patients had a significantly lower Western Ontario McMaster osteoarthritis index score ( median , 73 vs. 90 ; P = 0.016 ) than patients who healed uneventfully after internal fixation .


Health-related QOL ( SF-12 ) and patient independency did not differ significantly between the groups .


Gait analysis showed a significantly impaired progression of the center of pressure in the salvage surgery patients ( median ratio , -8.9 vs. 0.4 , P = 0.013 ) and a significant greater loss of abduction strength ( median , -25.4 vs. -20.4 N , P = 0.025 ) .


Despite a similar level of dependency and QOL , salvage arthroplasty patients have inferior functional outcome than patients who heal after internal fixation of a femoral neck fracture .


Therapeutic level III .


Among patients with acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation , less than 40 % regain functional independence when treated with intravenous tissue plasminogen activator ( t-PA ) alone .


Thrombectomy with the use of a stent retriever , in addition to intravenous t-PA , increases reperfusion rates and may improve long-term functional outcome .


We randomly assigned eligible patients with stroke who were receiving or had received intravenous t-PA to continue with t-PA alone ( control group ) or to undergo endovascular thrombectomy with the use of a stent retriever within 6 hours after symptom onset ( intervention group ) .


Patients had confirmed occlusions in the proximal anterior intracranial circulation and an absence of large ischemic-core lesions .


The primary outcome was the severity of global disability at 90 days , as assessed by means of the modified Rankin scale ( with scores ranging from 0 [ no symptoms ] to 6 [ death ] ) .


The study was stopped early because of efficacy .


At 39 centers , 196 patients underwent randomization ( 98 patients in each group ) .


In the intervention group , the median time from qualifying imaging to groin puncture was 57 minutes , and the rate of substantial reperfusion at the end of the procedure was 88 % .


Thrombectomy with the stent retriever plus intravenous t-PA reduced disability at 90 days over the entire range of scores on the modified Rankin scale ( P < 0.001 ) .


The rate of functional independence ( modified Rankin scale score , 0 to 2 ) was higher in the intervention group than in the control group ( 60 % vs. 35 % , P < 0.001 ) .


There were no significant between-group differences in 90-day mortality ( 9 % vs. 12 % , P = 0.50 ) or symptomatic intracranial hemorrhage ( 0 % vs. 3 % , P = 0.12 ) .


In patients receiving intravenous t-PA for acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation , thrombectomy with a stent retriever within 6 hours after onset improved functional outcomes at 90 days .


( Funded by Covidien ; SWIFT PRIME ClinicalTrials.gov number , NCT01657461 . )


Medication nonadherence is a common problem , resulting in significant human and economic cost , which can be a challenge to identify and resolve in practice .


Adherence tools have been developed to assist health care providers with managing medication nonadherence ; however , there is a need to develop a literature base for using adherence tools effectively .


To ( a ) describe the experiences and perspectives of pharmacists and student pharmacists using the Adherence Estimator ( AE ) and Drug Adherence Work-up ( DRAW ) tools and ( b ) describe medication nonadherence issues identified via use of the AE and DRAW tools in community pharmacies and outpatient clinics .


A practice-based study involving 6 primary care clinics and 4 community pharmacies in Iowa and Michigan was conducted .


Each adherence tool was administered approximately 20 times by pharmacists or student pharmacists to patients at each site , using a crossover design with randomization to the initial tool .


Sites determined how to incorporate tools into workflow and how to select patients .


Data from completed tools were analyzed descriptively .


Data from an online survey completed by tool administrators about their experiences and suggestions were analyzed thematically .


Sites submitted 209 AE and 179 DRAW tools .


Half of patients with a completed AE had at least 1 medication of medium or high risk of nonadherence , and 19 % had at least 1 medication of high risk .


For DRAW , 82 % of patients reported at least 1 yes answer for reasons for nonadherence , and 58 % reported 2 .


On average , the AE tool took 6.9 minutes , and the DRAW tool took 9.3 minutes .


Forty-four surveys were submitted ( 20 community and 24 clinic ) .


Two themes emerged from the open-ended responses : tool benefits and translating tools into practice .


While the tools were useful for identifying specific reasons for nonadherence and promoting dialogue , they required additional time and effort from both patients and pharmacists .


Health literacy , patient reluctance to discuss nonadherence , AE scaling , and DRAW length were voiced as concerns .


Both tools were useful for uncovering specific reasons for medication nonadherence in 5-10 minute encounters , but barriers exist to incorporating such tools into busy workflows .


Prior telemonitoring trials of blood pressure and blood glucose have shown improvements in blood pressure and glycemic targets .


However , implementation of telemonitoring in primary care practices may not yield the same results as research trials with extra resources and rigid protocols .


In this study we examined the process of implementing home telemonitoring of blood glucose and blood pressure for patients with diabetes in six primary care practices .


Grounded theory qualitative analysis was conducted in parallel with a randomized controlled effectiveness trial of home telemonitoring .


Data included semistructured interviews with 6 nurse care coordinators and 12 physicians in six participating practices and field notes from exit interviews with 93 of 108 randomized patients .


The three stakeholder groups ( patients , nurse care coordinators , and physicians ) exhibited some shared themes and some unique to the particular stakeholder group .


Major themes were that practices should ( 1 ) understand the capabilities and limitations of the technology and the willingness of patient and physician stakeholders to use it , ( 2 ) understand the workflow , flow of information , and human factors needed to optimize use of the technology , ( 3 ) engage and prepare the physicians , and ( 4 ) involve the patient in the process .


Although there was enthusiasm for a patient-centered medical home model that included between-visit telemonitoring , there was concern about the support and resources needed to provide this service to patients .


As with many technology interventions , careful consideration of workflow and information flow will help enable effective implementations .


Because smoking has a profound impact on socioeconomic disparities in illness and death , it is crucial that vulnerable populations of smokers be targeted with treatment .


The U.S. Public Health Service recommends that all patients be asked about their smoking at every visit and that smokers be given brief advice to quit and referred to treatment .


Initiatives to facilitate these practices include the 5A 's ( ask , advise , assess , assist , arrange ) and Ask-Advise-Refer ( AAR ) .


Unfortunately , primary care referrals are low , and most smokers referred fail to enroll .


This study evaluated the efficacy of the Ask-Advise-Connect ( AAC ) approach to linking smokers with treatment in a large , safety net public healthcare system .


The study design was a pair-matched group-randomized trial with two treatment arms .


Ten safety net clinics in Houston TX .


Clinics were randomized to AAC ( n = 5 ; intervention ) or AAR ( n = 5 ; control ) .


Licensed vocational nurses ( LVNs ) were trained to assess and record the smoking status of all patients at all visits in the electronic health record .


Smokers were given brief advice to quit .


In AAC , the names and phone numbers of smokers who agreed to be connected were sent electronically to the Texas quitline daily , and patients were proactively called by the quitline within 48 hours .


In AAR , smokers were offered a quitline referral card and encouraged to call on their own .


Data were collected between June 2010 and March 2012 and analyzed in 2012 .


The primary outcome was impact , defined here as the proportion of identified smokers that enrolled in treatment .


The impact ( proportion of identified smokers who enrolled in treatment ) of AAC ( 14.7 % ) was significantly greater than the impact of AAR ( 0.5 % ) , t ( 4 ) = 14.61 , p = 0.0001 , OR = 32.10 ( 95 % CI = 16.60 , 62.06 ) .


The AAC approach to aiding smoking cessation has tremendous potential to reduce tobacco-related health disparities .


Nanosomal docetaxel lipid suspension formulation was developed to eliminate ethanol and polysorbate 80 from the currently used docetaxel ( Taxotere ) drug for treatment of cancer patients .


NDLS clinical safety and efficacy was evaluated and compared with Taxotere at 75 mg/m ( 2 ) in metastatic breast cancer patients .


A total of 72 patients were randomized in a ratio of 2:1 ( NDLS : Taxotere ) .


Patients treated with NDLS were not premedicated with corticosteroids as required with solvent-based Taxotere .


Disease status and tumor response was assessed after every 2 cycles of treatment using Response Evaluation Criteria in Solid Tumors 1.1 guidelines through cycle6 .


Overall therapeutic response ( complete + partial ) rate in metastatic breast cancer patients treated with NDLS and Taxotere were 35.5 % and 26.3 % , respectively , indicating better response in patients treated with NDLS .


Patients in the NDLS group were not premedicated but the safety results of NDLS were found to be comparable with Taxotere .


NDLS formulation with no premedication provides an alternative treatment option for breast cancer patients .


Social anxiety disorder ( SAD ) impacts social , occupational and academic functioning .


Although many interventions report change in social distress , improvement in social behavior remains under-addressed .


This investigation examined the additive impact of social skills training ( SST ) for the treatment of SAD .


Using a sample of 106 adults who endorsed SAD across numerous social settings , participants were randomized to exposure therapy ( imaginal and in vivo ) alone , a combination of SST and exposure therapy known as Social Effectiveness Therapy ( SET ) , or a wait list control .


The assessment strategy included self-report measures , blinded clinical ratings and blinded assessment of social behavior .


Both interventions significantly reduced distress in comparison to the wait list control and at post-treatment , 67 % of patients treated with SET and 54 % of patients treated with exposure therapy alone no longer met diagnostic criteria for SAD , a difference that was not statistically significant .


When compared to exposure therapy alone , SET produced superior outcomes ( p < .05 ) on measures of social skill and general clinical status .


In addition to statistical significance , participants treated with SET or exposure reported clinically significant decreases on two measures of self-reported social anxiety and several measures of observed social behavior ( all ps < .05 ) .


Both interventions produced efficacious treatment outcome , although SET may provide additional benefit on measures of social distress and social behavior .


To determine the impact of losing health insurance coverage on perceived need for and access to mental health care in women screened for postpartum depression ( PPD ) in primary care settings .


The study sample included 2343 women enrolled in a 12-month , multisite , randomized trial that compared clinical outcomes of a comprehensive PPD screening and management program with usual care ( March 1 , 2006 , through August 31 , 2010 ) .


Screening for PPD occurred at the first postpartum visit ( 5-12 weeks ) using the Edinburgh Postnatal Depression Scale followed by the 9-item Patient Health Questionnaire .


Insurance status during the prenatal period , at delivery , and during the first postpartum year and perceived need for and access to mental health care during the first postpartum year were assessed via questionnaires completed by individual patients and participating practices .


Rates of uninsured increased from 3.8 % during pregnancy and delivery ( n = 87 of 2317 ) to 10.8 % at the first postpartum visit ( n = 253 of 2343 ) and 13.7 % at any subsequent visit to the practice after 2 months post partum ( n = 226 of 1646 ) ( P < .001 , both comparisons vs baseline ) .


For patients with data on insurance type during follow-up , insurance loss occurred primarily in Medicaid beneficiaries .


Nine-item Patient Health Questionnaire scores and self-reported need for mental health care did not differ significantly between patients who remained insured and those who lost insurance during the first postpartum year .


However , of patients who reported the need for mental health care , 61.1 % of the uninsured ( n = 66 of 108 ) vs 27.1 % of the insured ( n = 49 of 181 ) reported an inability to obtain mental health care ( P < .001 ) .


Loss of insurance during the first postpartum year did not significantly affect depressive symptoms or perceived need for mental health care but did adversely affect self-reported ability to obtain mental health care .


In most treated patients with hypertension , a two or more drug combination is required to achieve adequate blood pressure ( BP ) control .


In our study we assessed whether the combination of zofenopril + hydrochlorothiazide ( HCTZ ) was at least as effective as irbesartan + HCTZ in essential hypertensives with at least one additional cardiovascular risk factor , uncontrolled by a previous monotherapy .


After a 2-week placebo washout , 361 treated hypertensive patients [ office sitting diastolic BP ( DBP ) , 90mmHg ] , aged 18-75years , were randomized double blind to 18-week treatment with zofenopril 30mg plus HCTZ 12.5 mg or irbesartan 150mg plus HCTZ 12.5 mg once daily , in an international , multicenter study .


After the first 6 and 12weeks , zofenopril and irbesartan doses could be doubled in non-normalized subjects .


The primary study end point was the office sitting DBP reduction after 18weeks of treatment .


Secondary end points included office systolic BP ( SBP ) , ambulatory BP and high sensitivity C-reactive protein ( hs-CRP ) .


The between-treatment difference for office DBP averaged to +1.0 ( 95 % CI -0.4 , +0.8 ) mmHg ( P = 0.150 ) , the upper limit of the 95 % confidence interval being inferior to the protocol-defined non-inferiority limit ( 3mmHg ) .


In the subset of patients with valid ambulatory BP , no difference in 24-h average DBP [ n = 181 ; 6.7 ( 8.7 , 4.6 ) zofenopril + HCTZ vs. 6.3 ( 8.8 , 3.7 ) mmHg irbesartan + HCTZ , P = 0.810 ] and SBP reductions [ 11.7 ( 15.4 , 8.0 ) vs. 12.6 ( 17.2 , 8.0 ) mmHg , P = 0.758 ] were observed between the two treatment groups .


hs-CRP was reduced by zofenopril + HCTZ [ -0.52 ( -1.05 , 0.01 ) mg/L ] , while it was increased by irbesartan plus HCTZ [ 0.97 ( 0.29 , 1.65 ) mg/L , P = 0.001 between treatments ] .


In previously monotherapy-treated , uncontrolled patients with hypertension , zofenopril 30-60mg + HCTZ 12.5 mg is as effective as irbesartan 150-300mg plus HCTZ 12.5 mg , with the added value of a potential protective effect against vascular inflammation .


Antithrombotic drugs , such as low-dose aspirin ( LDA ) and clopidogrel , can cause upper gastrointestinal complications .


The goal of the present study was to investigate whether a mucosal-protective agent , rebamipide , could prevent gastric mucosal injuries induced by LDA with or without clopidogrel in healthy subjects .


A randomized , double-blind , placebo-controlled trial was performed with 32 healthy male volunteers .


Subjects were randomly assigned to a 14-day course of one of the following regimens : group A , placebo ( tid ) + LDA ; group B , rebamipide ( 100 mg tid ) + LDA ( 100 mg once-daily ) ; group C , placebo + LDA + clopidogrel ( 75 mg once-daily ) ; or group D , rebamipide + LDA + clopidogrel .


The grade of gastric mucosal injuries was evaluated by esophagogastroduodenoscopy before and after dosing ( on day 0 and day 14 ) , and the grade of gastric mucosal injury was assessed according to the modified Lanza score .


Subjective symptoms were assessed using the Gastrointestinal Symptom Rating Scale ( GSRS ) .


A rapid urease test was performed on day 0 , and blood tests were performed on day 0 and day 14 .


Rebamipide significantly inhibited gastric mucosal injury induced by LDA alone or by LDA plus clopidogrel when compared with placebo in healthy subjects .


GSRS score and hemoglobin level were not significantly different among the four groups .


Rebamipide is useful for the primary prevention of gastric mucosal injury induced by LDA alone or by LDA plus clopidogrel in healthy subjects .


A new twice daily sustained-release ( SR ) paracetamol formulation was developed to improve convenience and enhance patient compliance for treatment of pain from chronic diseases .


This research aimed to evaluate bioavailability and compare pharmacokinetic ( PK ) properties of the new SR paracetamol formulation ( 2x1 ,000 mg ) with those of immediate-release ( IR ) paracetamol ( 2x500 mg ) and existing extended-release ( ER ) paracetamol ( 2x665 mg ) .


Two randomized , single-dose , 4-way crossover studies were conducted .


A total of 28 healthy male and female volunteers participated in each study .


The relative bioavailability , partial extent of absorption , overall elimination , food effect , and safety were evaluated .


The estimates of relative bioavailability of new SR with IR formulation based on dose-adjusted AUC0-inf were 91 % ( 0.86-0 .96 ) for the fasted state and 99 % ( 0.95-1 .02 ) for the fed state , while these estimates comparing new SR with ER formulation were 99 % ( 0.96-1 .03 ) in the fasted state and 98 % ( 0.95-1 .02 ) in the fed state .


The accumulated mean time period at or above the minimal therapeutic plasma paracetamol concentration for the new SR was from 90 % to 112 % longer than that of the IR formulation , in fasted and fed state , respectively .


Food significantly increased Cmax of SR formulation , with ratios fast vs. fed 0.79 ( p < 0.0001 ) and 0.77 ( p < 0.0001 ) in study I and II , respectively .


The new SR formulation was well absorbed , with more than 90 % relative bioavailability as compared to the currently marketed IR and ER products and better sustained-release PK characteristics , which make it suitable for twice-daily paracetamol treatment .


To use a high-quality multicenter trial dataset to determine dose-volume effects for gastrointestinal ( GI ) toxicity following radiation therapy for prostate carcinoma .


Influential dose-volume histogram regions were to be determined as functions of dose , anatomical location , toxicity , and clinical endpoint .


Planning datasets for 754 participants in the TROG 03.04 RADAR trial were available , with Late Effects of Normal Tissues ( LENT ) Subjective , Objective , Management , and Analytic ( SOMA ) toxicity assessment to a median of 72 months .


A rank sum method was used to define dose-volume cut-points as near-continuous functions of dose to 3 GI anatomical regions , together with a comprehensive assessment of significance .


Univariate and multivariate ordinal regression was used to assess the importance of cut-points at each dose .


Dose ranges providing significant cut-points tended to be consistent with those showing significant univariate regression odds-ratios ( representing the probability of a unitary increase in toxicity grade per percent relative volume ) .


Ranges of significant cut-points for rectal bleeding validated previously published results .


Separation of the lower GI anatomy into complete anorectum , rectum , and anal canal showed the impact of mid-low doses to the anal canal on urgency and tenesmus , completeness of evacuation and stool frequency , and mid-high doses to the anorectum on bleeding and stool frequency .


Derived multivariate models emphasized the importance of the high-dose region of the anorectum and rectum for rectal bleeding and mid - to low-dose regions for diarrhea and urgency and tenesmus , and low-to-mid doses to the anal canal for stool frequency , diarrhea , evacuation , and bleeding .


Results confirm anatomical dependence of specific GI toxicities .


They provide an atlas summarizing dose-histogram effects and derived constraints as functions of anatomical region , dose , toxicity , and endpoint for informing future radiation therapy planning .


In the Interventional Management of Stroke ( IMS ) III trial , we sought to demonstrate evidence of a differential treatment effect of endovascular treatment of acute ischemic stroke compared with intravenous tissue-type plasminogen activator , according to baseline collateral status measured using computed tomographic angiography .


Of 656 patients enrolled in Interventional Management of Stroke III trial , 306 had baseline computed tomographic angiography .


Of these , 185 patients had M1 middle cerebral artery intracranial internal carotid artery occlusion , where baseline collateral status could be measured .


Collateral status was assessed by consensus using 3 different ordinal scales and categorized as good , intermediate , and poor .


Multivariable modeling was used to assess the effect of collateral status and treatment type on clinical outcome by modified Rankin Scale ( mRS 0-2 , mRS 0-1 , and the ordinal mRS ) .


Of 185 patients , 126 randomized to endovascular therapy ( 87.6 % recanalized , 41.3 % 90-day mRS 0-2 ) and 59 to intravenous tissue-type plasminogen activator only ( 60.5 % recanalized , 30.5 % 90-day mRS 0-2 ) .


In multivariable modeling , collateral status was a significant predictor of all clinical outcomes ( P < 0.05 ) .


Maximal benefit with endovascular treatment across all clinical outcomes was seen in patients with intermediate collaterals , some benefit in patients with good collaterals , and none in patients with poor collaterals , although small sample size limited the power of the analysis to show a statistically significant interaction between collateral status and treatment type ( P > 0.05 ) .


Using data from a large randomized controlled trial ( IMS III ) , we show that baseline computed tomographic angiography collaterals are a robust determinant of final clinical outcome and could be used to select patients for endovascular therapy .


URL : http://www.clinicaltrials.gov/ct2/show/ .


Unique identifier : 0020NCT00359424 .


The combination of an ultrathin bronchoscope , navigational technology , and endobronchial ultrasound ( EBUS ) seems to combine the best of mutual abilities for evaluating peripheral pulmonary lesions , but ultrathin bronchoscopes that allow the use of EBUS have not been developed so far .


To compare the diagnostic yield of transbronchial biopsy under EBUS , fluoroscopy , and virtual bronchoscopic navigation guidance using a novel ultrathin bronchoscope with that using a thin bronchoscope with a guide sheath for peripheral pulmonary lesions .


In four centers , patients with suspected peripheral pulmonary lesions less than or equal to 30 mm in the longest diameter were included and randomized to undergo transbronchial biopsy with EBUS , fluoroscopy , and virtual bronchoscopic navigation guidance using a 3.0-mm ultrathin bronchoscope ( UTB group ) or a 4.0-mm thin bronchoscope with a guide sheath ( TB-GS group ) .


A total of 310 patients were enrolled and randomized , among whom 305 patients ( 150 , UTB group ; 155 , TB-GS group ) were analyzed .


The ultrathin bronchoscope could reach more distal bronchi than the thin bronchoscope ( median fifth - vs. fourth-generation bronchi ; P < 0.001 ) .


Diagnostic histologic specimens were obtained in 74 % ( 42 % for benign and 81 % for malignant lesions ) of the UTB group and 59 % ( 36 % for benign and 70 % for malignant lesions ) of the TB-GS group ( P = 0.044 , Mantel-Haenszel test ) .


Complications including pneumothorax , bleeding , chest pain , and pneumonia occurred in 3 % and 5 % in the respective groups .


The diagnostic yield of the UTB method is higher than that of the TB-GS method .


Clinical trial registered with www.umin.ac.jp/ctr/ ( UMIN 000003177 ) .


To compare the function of retinal ganglion cells ( RGCs ) using the photopic negative response ( PhNR ) in patients who had undergone indocyaine green ( ICG ) - assisted , brilliant blue G ( BBG ) - assisted , or triamcinolone acetonide ( TA ) - assisted internal limiting membrane ( ILM ) peeling during macular hole ( MH ) surgery .


Forty-eight eyes of 48 patients with a macular hole were randomly divided into those undergoing ICG-assisted , BBG-assisted , or TA-assisted vitrectomy ( n = 16 for each group ) .


Full-field cone ERGs were recorded before and 1 , 3 , 6 , 9 , and 12months postoperatively .


The amplitudes and implicit times of the a-waves and b-waves and the amplitudes of the oscillatory potentials ( OPs ) and PhNRs were measured .


The mean deviations ( MDs ) of standard automated perimetry and the best-corrected visual acuity ( BCVA ) were measured .


The circumferential retinal nerve fiber layer ( RNFL ) thickness was evaluated by SD-OCT .


All macular holes were closed with a significant improvement of the BCVA and MD without differences among the groups .


There was no significant difference between the preoperative and postoperative RNFL thickness .


The implicit times of the a-waves and b-waves were significantly prolonged , and the OPs amplitude was significantly decreased postoperatively in all groups .


These ERG changes were not significantly different among the groups .


The postoperative PhNR amplitudes were significantly lower in the ICG group than in the BBG or TA group .


The results indicate that the PhNR may detect subclinical impairments of RGCs caused by the possible toxic effect of ICG .


This finding adds to the data that BBG and TA may be safer than ICG for use during MH surgery .


Standard therapies for severe dry eye are limited and fail to resolve the problem .


The purpose of this study was to evaluate the safety and efficacy of Thymosin 4 eye drops ( RGN-259 ) as a novel therapy for severe dry eye disease ( including that associated with graft vs. host disease ) .


A small , multicenter , randomized , double-masked , placebo-controlled 56-day phase 2 clinical trial including a 28-day follow-up at 2 US sites .


Nine patients with severe dry eye were treated with either RGN-259 ( 0.1 % ) or vehicle control 6 times daily over a period of 28 days .


Dry eye sign and symptom assessments , such as ocular discomfort ( using the OSDI questionnaire ) and corneal fluorescein staining ( using the NEI workshop grading system ) , were evaluated at various time points .


Statistically significant differences in both symptom and sign assessments , were seen at various time points throughout the study .


Of particular note at day 56 , the RGN-259-treated group ( 12 eyes ) had 35.1 % reduction of ocular discomfort compared with vehicle control ( 6 eyes ) ( P = 0.0141 ) , and 59.1 % reduction of total corneal fluorescein staining compared with vehicle control ( P = 0.0108 ) .


Other improvements seen in the RGN-259-treated patients included tear film breakup time and increased tear volume production .


In this small trial , RGN-259 eye drops were safe and well tolerated and met key efficacy objectives with statistically significant symptom and sign improvements , compared with vehicle control , at various time intervals , including 28-days posttreatment .


CLINICAL TRIAL REGISTRATION -- URL : http://www.clinicaltrials.gov .


Unique identifier : NCT01393132 .


Single-agent gemcitabine ( GEM ) has been considered for many years as the standard first-line treatment for advanced pancreatic cancer .


However , recently , several studies reported encouraging activity and good tolerability for some combination regimens .


Considering the apparently non-overlapping toxicity and the proved individual efficacy of GEM , oxaliplatin ( L-OHP ) , and capecitabine ( CAP ) , this randomized phase II study compared the activity and safety of the combination GEM , L-OHP , and CAP ( GEMOXEL ) versus GEM alone , in patients with metastatic pancreatic cancer .


The treatment in GEMOXEL arm consisted of GEM 1,000 mg/m ( 2 ) as a 30-min intravenous infusion on days 1 , 8 , 15 , 22 , L-OHP 100 mg/m ( 2 ) i.v. on day 2 , and CAP 1,500 mg/m ( 2 ) / day in two divided doses on days 1-14 , every 21 days ( one cycle ) .


In both treatment groups , GEM was administered weekly for seven consecutive weeks followed by 1-week rest for the first 8 weeks , and thereafter , GEM was continued on days 1 , 8 , 15 , every 28 days .


Chemotherapy was administered until disease progression or unacceptable toxicity .


Sixty-seven patients were enrolled in the study .


Thirty-four were randomly assigned to GEMOXEL and 33 to GEM .


At 4 months , disease control rate was 79.4 % with GEMOXEL versus 45.4 % with GEM ( p = 0.004 ) .


The median progression-free survival was 6.8 months ( 95 % CI 5.3-7 .3 months ) in GEMOXEL arm and 3.7 months ( 95 % CI 2.9-4 .7 months ) in GEM arm ( p < 0.001 ) .


The median OS was 11.9 months ( 95 % CI 10.6-12 .9 months ) in GEMOXEL arm and 7.1 months ( 95 % CI 5.5-9 .1 months ) in GEM arm ( p < 0.001 ) .


Hematologic and non-hematologic toxicity was more severe with combination chemotherapy , yet still tolerable .


No grade 4 adverse events were observed with either regimen .


GEMOXEL regimen seemed to be safe and more efficient than the standard therapy with GEM alone in the treatment of metastatic pancreatic cancer .


Long-distance air travel is associated with an increased risk of venous thrombosis .


The most obvious factor that can explain air travel-related thrombosis is prolonged seated immobilization .


In addition , hypobaric hypoxia has been shown to affect coagulation , and the lowered atmospheric pressures present in the cabin during the flight may therefore play an etiologic role .


Because immobilization and hypoxic conditions are usually present simultaneously in airplanes or hypobaric chambers , their separate effects on the coagulation system or on thrombosis risk have not been studied extensively .


To investigate the separate effects of long-term immobilization and profound prolonged hypoxia on blood coagulation .


We performed two studies in collaboration with European Space Agency/European Space Research and Technology Centre .


In the first study , 24 healthy , non-smoking , adult women underwent 60 days of -6 head-down bed rest .


In the second study , we took blood samples from 25 healthy men who participated during their stay in the Concordia station in Antarctica , where , due to the atmospheric conditions , continuous severe hypobaric hypoxia is present .


In both studies , we measured markers of blood coagulation at baseline and at several time points during the exposures .


We observed no increase in coagulation markers during immobilization or in the hypobaric environment , compared with baseline measurements .


Our results indicate that neither immobilization nor hypoxia per se affects blood coagulation .


These results implicate that a combination of risk factors is necessary to induce the coagulation system during air travel .


A proposal has recently been made regarding the potential adjuvant use of platelet-rich plasma ( PRP ) with fractional carbon dioxide laser ( FCL ) for the correction of acne scars .


To compare the efficacy and safety of two administration modes of autologous PRP ( intradermal injection ( ID ) and topical application ) after FCL with that of FCL alone in the treatment of atrophic acne scars .


Thirty patients were randomly divided into two groups .


Both underwent split-face therapy .


Group 1 was administered FCL followed by ID PRP on one side and FCL followed by ID saline on the other .


In group 2 , one cheek was treated with FCL followed by ID PRP , and the other received FCL followed by topical PRP .


Each patient received 3monthly sessions .


The final assessment took place at 6months .


Combined PRP - and FCL-treated areas had a significantly better response ( p = .03 ) , fewer side effects , and shorter downtime ( p = .02 ) than FCL-treated areas , but there were no significant differences in ID - and topical PRP-treated areas in degree of response and downtime ( p = .10 ) ; topically treated areas had significantly lower pain scores .


The current study introduces the combination of topical PRP and FCL as an effective , safe modality in the treatment of atrophic acne scars with shorter downtime than FCL alone and better tolerability than FCL combined with ID PRP .


The need for evidence-based practice in nursing is well established ; however , the efficacy of providing online research resources to nurses delivering care at the bedside has yet to undergo empirical testing .


This study evaluated the impact of minimal educational support by a nurse researcher on nurses ' usage of a hospital-based online nursing reference center .


This randomized , comparison group design feasibility study was conducted at a suburban medical center .


Real-time RN usage of an online nursing reference center was collected over 10 months ( August to May ) , with the comparative intervention occurring for seven of the 10 months ( September to March ) .


Independent samples t tests and analysis of variance demonstrated that nurses receiving weekly or biweekly visits from an educator had significantly higher usage of the reference center .


Nurses who received minimal educational support through weekly and biweekly brief , verbally supportive visits from a nurse researcher were significantly higher users of the online nurse reference center than those receiving in-services only .


The aim of this study was compare the Aldrete score at 5 minutes of two groups of patients undergoing carotid endarterectomy with intravenous anesthesia , receiving either anesthetic superficial cervical plexus block or intravenous morphine as transition analgesia .


After Ethics Committee approval , this randomized , controlled , double-blind , single-center study was performed on patients undergoing carotid endarterectomy , who received total intravenous anesthesia with propofol and remifentanil infusion .


After intubation , each patient was randomly assigned to Block ( superficial cervical block with levobupivacaine before the surgical incision ) , or Morphine group ( standardized dose of morphine 30 minutes before the end of surgery ) .


In the recovery room , an investigator unaware of the patient randomization recorded time to extubation , Aldrete score , pain , nausea/vomiting , and shiver at T0 ( time of extubation ) , and at 5 ( T5 ) , 10 ( T10 ) , and 30 minutes ( T30 ) after extubation .


Sixty-four patients were studied .


Time to extubation was 11 6 min for Block and 20 10 min for Morphine group ( P > 0.001 ) .


Median Aldrete score at T0 was 9 in the Block and 6.5 in the Morphine group ( P < 0.001 ) , at T5 it was 8.5 and 7.0 ( P < 0.001 ) , respectively .


At T5 , 29 ( 90.6 % ) Block and 8 ( 25 % ) Morphine patients had an Aldrete score 8 ( P < 0.001 ) .


Systolic blood pressure was higher in the Block than in Morphine patients at T0 and T5 .


This study demonstrates shorter time to extubation and better emergence from anesthesia when total intravenous anesthesia is associated with superficial cervical block than with morphine as transition analgesia .


The data of MARCH ( Metformin and AcaRbose in Chinese as the initial Hypoglycaemic treatment ) trial demonstrated that acarbose and metformin have similar efficacy as initial therapy for hemoglobin A1c ( HbA1c ) reduction in Chinese patients with newly diagnosed type 2 diabetes .


We investigated whether the therapeutic efficacy was diversified under different body mass index ( BMI ) status .


All 784 subjects were divided into normal-weight group ( BMI < 24 kg/m2 ) , overweight group ( BMI 24-28 kg/m2 ) and obese group ( BMI28 kg/m2 ) .


Patients were assigned to 48 weeks of therapy with acarbose or metformin , respectively .


The clinical trial registry number was ChiCTR-TRC-08000231 .


The reduction of HbA1c levels and the proportion of patients with HbA1c of 6.5 % or less were similar in the three groups after acarbose and metformin treatment .


In overweight group , fasting blood glucose ( FBG ) after metformin treatment showed greater decline compared to acarbose group at 48 weeks [ -1.73 ( -1.99 to -1.46 ) vs. -1.37 ( -1.61 to -1.12 ) , P < 0.05 ) , however the decrease of 2 h post-challenge blood glucose ( PBG ) after acarbose treatment at 48 weeks was bigger compared to metformin group [ -3.34 ( -3.83 to-2 .84 ) vs. -2.35 ( -2.85 to -1.85 ) , P < 0.01 ] .


Both acarbose and metformin treatment resulted in a significant decrease in waist circumference , hip circumference , weight and BMI in the three groups ( all P < 0.05 ) .


Acarbose and metformin decreased HbA1c levels similarly regardless of BMI status of Chinese type 2 diabetic patients .


Acarbose and metformin resulted in a significant and modest improvement of anthropometric parametres in different BMI status .


Thus , acarbose treatment may contribute a similar effect on plasma glucose control compared to metformin , even in obesity patients .


ChiCTR.org ChiCTR-TRC-08000231 .


According to the latest ART report for Europe , about 13 % of pregnancies after frozen embryo transfer are multiple .


Our objective was to analyse the impact on the multiple pregnancy rate of two eSFET ( elective single frozen embryo transfers ) versus a DFET ( double frozen embryo transfer ) in women aged under 38 years , who had not achieved pregnancy in their fresh transfer and who had at least two vitrified embryos of A/B quality .


This study was conducted from January 2010 to June 2013 at a public hospital .


The couples were divided into three groups .


Group DFET : the first cryotransfer of two embryos ( 105 women ) ; cSFET group : the only cryotransfer of a single vitrified embryo ( 60 women ) ; eSFET group , individually vitrified embryos : 20 patients included in a clinical trial of single-embryo fresh and frozen transfer and 21 patients who chose to receive eSFET .


The clinical pregnancy rate was 38.1 % in the DET group and the cumulative clinical pregnancy rate was 43.3 % in the eSFET group .


There were no significant differences between the DFET and eSFET groups ( 30.0 vs 34.1 % ) in cumulative live birth delivery rate .


The rate of multiple pregnancies varied significantly between the DFET and eSFET groups ( 32.5 vs 0 % , p < 0.05 ) .


For good-prognosis women aged under 38 years , taking embryo quality as a criterion for inclusion , an eSFET policy can be applied , achieving acceptable cumulative clinical pregnancy and live birth rates and reducing multiple pregnancy rates .


Relapses of childhood steroid-sensitive nephrotic syndrome ( SSNS ) are treated with a 4 - to 8-week course of high-dose oral prednisolone , which may be associated with significant adverse effects .


There is a clear association between upper respiratory tract infection ( URTI ) and relapse development .


Previous studies in developing nations have suggested that introducing a 5 - to 7-day course of daily prednisolone during an URTI may prevent a relapse developing and the need for a treatment course of high-dose prednisolone .


The aim of PREDNOS 2 is to evaluate the effectiveness of a 6-day course of daily prednisolone therapy during an URTI in reducing the development of a subsequent relapse in a developed nation .


The subjects will be 300 children with relapsing SSNS ( 2 relapses in preceding year ) , who will be randomised to receive either a 6-day course of daily prednisolone or no change to their current therapy ( with the use of placebo to double blind ) each time they develop an URTI over 12months .


A strict definition for URTI will be used .


Subjects will be reviewed at 3 , 6 , 9 and 12months to capture data regarding relapse history , ongoing therapy and adverse effect profile , including behavioural problems and quality of life .


A formal health economic analysis will also be performed .


The primary end point of the study will be the incidence of URTI-related relapse ( 3days of Albustix + + + ) following the first infection during the 12-month follow-up period .


DNA and RNA samples will be collected to identify a potential genetic cause for the disease .


Subjects will be recruited from over 100 UK centres with the assistance of the Medicines for Children Research Network.PREDNOS 2 is funded by the National Institute for Health Research Health Technology Assessment Programme ( 11/129/261 ) .


We propose that PREDNOS 2 will be a pivotal study that will inform the future standard of care for children with SSNS .


If it is possible to reduce the disease relapse rate effectively and safely , this will reduce the morbidity and cost associated with drug treatment , notwithstanding hospital admission and parental absence from employment .


Current Controlled Trials ( ISRCTN10900733 ) .


To determine the difference in outcome between a 1 - day and 5 - day antibiotic regimen in the prevention of infective complications following transrectal prostate biopsy .


This prospective comparative study was done in the urology unit of University of Benin Teaching Hospital over a period of 14 months .


Eighty seven patients were randomly assigned to 2 groups prior to the procedure .


The patients in group I ( N = 42 ) received oral ciprofloxacin ( 500mg , 12 hourly ) and oral metronidazole ( 400mg , 8 hourly ) for 1 day while those in group II ( N = 45 ) received same antibiotic combination for 5 days .


Urine samples for culture were taken an hour before the procedure and then 5 days after in all patients .


Temperature monitoring with an easy-to-use thermometer was done thrice daily by the patients .


Post biopsy fever and positive urine cultures were indicative of infection .


The mean age of the patients was 68.5 8.1 years .


Infective complications occurred in 8 ( 19 % ) in group I and 7 ( 15.6 % ) in group II .


Fever was noted in 5 patients in group I and 4 patients in group II ( p = 0.73 ) while positive urine culture was noted in 4 patients in each group ( p = 1.00 ) .


Complications were minor and transient except in a case of septicaemia in group II that required hospitalisation .


Escherischia coli was the most common organism isolated from positive urine cultures .


A 1-day antibiotic regimen of oral ciprofloxacin and metronidazole is as effective as a 5-day regimenin the prevention of infective complications following transrectalprostate biopsy .


The use of perioperative pharmacologic - blockade in patients at low risk of myocardial ischemic events undergoing noncardiac surgery ( NCS ) is controversial because of the risk of stroke and hypotension .


Published studies have not found a consistent benefit in this cohort .


To determine the effect of perioperative - blockade on patients undergoing NCS , particularly those with no risk factors .


This is a retrospective observational analysis of patients undergoing surgery in Veterans Affairs hospitals from October 1 , 2008 , through September 31 , 2013 .


- Blocker use was determined if a dose was ordered at any time between 8 hours before surgery and 24 hours postoperatively .


Data from the Veterans Affairs electronic database included demographics , diagnosis and procedural codes , medications , perioperative laboratory values , and date of death .


A 4-point cardiac risk score was calculated by assigning 1 point each for renal failure , coronary artery disease , diabetes mellitus , and surgery in a major body cavity .


Previously validated linear regression models for all hospitalized acute care medical or surgical patients were used to calculate predicted mortality and then to calculate odds ratios ( ORs ) .


The end point was 30-day surgical mortality .


There were 326,489 patients in this cohort : 314,114 underwent NCS and 12,375 underwent cardiac surgery .


- Blockade lowered the OR for mortality significantly in patients with 3 to 4 cardiac risk factors undergoing NCS ( OR , 0.63 ; 95 % CI , 0.43-0 .93 ) .


It had no effect on patients with 1 to 2 risk factors .


However , - blockade resulted in a significantly higher chance of death in patients ( OR , 1.19 ; 95 % CI , 1.06-1 .35 ) with no risk factors undergoing NCS .


In this large series , - blockade appears to be beneficial perioperatively in patients with high cardiac risk undergoing NCS .


However , the use of - blockers in patients with no cardiac risk factors undergoing NCS increased risk of death in this patient cohort .


The role of positive end-expiratory pressure in mechanical ventilation during general anaesthesia for surgery remains uncertain .


Levels of pressure higher than 0 cm H2O might protect against postoperative pulmonary complications but could also cause intraoperative circulatory depression and lung injury from overdistension .


We tested the hypothesis that a high level of positive end-expiratory pressure with recruitment manoeuvres protects against postoperative pulmonary complications in patients at risk of complications who are receiving mechanical ventilation with low tidal volumes during general anaesthesia for open abdominal surgery .


In this randomised controlled trial at 30 centres in Europe and North and South America , we recruited 900 patients at risk for postoperative pulmonary complications who were planned for open abdominal surgery under general anaesthesia and ventilation at tidal volumes of 8 mL/kg .


We randomly allocated patients to either a high level of positive end-expiratory pressure ( 12 cm H2O ) with recruitment manoeuvres ( higher PEEP group ) or a low level of pressure ( 2 cm H2O ) without recruitment manoeuvres ( lower PEEP group ) .


We used a centralised computer-generated randomisation system .


Patients and outcome assessors were masked to the intervention .


Primary endpoint was a composite of postoperative pulmonary complications by postoperative day 5 .


Analysis was by intention-to-treat .


The study is registered at Controlled-Trials .


com , number ISRCTN70332574 .


From February , 2011 , to January , 2013 , 447 patients were randomly allocated to the higher PEEP group and 453 to the lower PEEP group .


Six patients were excluded from the analysis , four because they withdrew consent and two for violation of inclusion criteria .


Median levels of positive end-expiratory pressure were 12 cm H2O ( IQR 12-12 ) in the higher PEEP group and 2 cm H2O ( 0-2 ) in the lower PEEP group .


Postoperative pulmonary complications were reported in 174 ( 40 % ) of 445 patients in the higher PEEP group versus 172 ( 39 % ) of 449 patients in the lower PEEP group ( relative risk 101 ; 95 % CI 086-120 ; p = 086 ) .


Compared with patients in the lower PEEP group , those in the higher PEEP group developed intraoperative hypotension and needed more vasoactive drugs .


A strategy with a high level of positive end-expiratory pressure and recruitment manoeuvres during open abdominal surgery does not protect against postoperative pulmonary complications .