Primary outcome was insulin secretory function , which was evaluated in response to graded infusions of glucose and day-long mixed meals .


Liraglutide treatment ( n = @ ) significantly ( p@ @ ) increased the insulin secretion rate ( % mean change -LSB- @ % CI -RSB- ; @ % -LSB- @ , @ -RSB- vs -@ % -LSB- -@ , @ -RSB- ) and pancreatic beta cell sensitivity to intravenous glucose ( @ % -LSB- @ , @ -RSB- vs -@ % ( -@ , @ -RSB- ) , and decreased insulin clearance rate ( -@ % -LSB- -@ , @ -RSB- vs @ -LSB- @ , @ -RSB- ) as compared with placebo ( n = @ ) .


The liraglutide-treated group also had significantly ( p@ @ ) lower day-long glucose ( -@ % -LSB- -@ , -@ -RSB- vs -@ -LSB- -@ , @ -RSB- ) and NEFA concentrations ( -@ -LSB- -@ , -@ -RSB- vs -@ -LSB- -@ , @ -RSB- ) following mixed meals , whereas day-long insulin concentrations did not significantly differ as compared with placebo .


In a multivariate regression analysis , weight loss was associated with a decrease in insulin secretion rate and day-long glucose and insulin concentrations in the placebo group ( p@ @ ) , but there was no association with weight loss in the liraglutide group .


The most common side effect of liraglutide was nausea .


A direct stimulatory effect on beta cell function was the predominant change in liraglutide-augmented weight loss .


These changes appear to be independent of weight loss .


The purpose of this study was to compare the performance of a @-gauge fenestrated catheter with an @-gauge nonfenestrated catheter for i.v. contrast infusion during MDCT .


Two hundred five adult outpatients imaged on a dual-source @-MDCT scanner with arterial phase body CT ( flow rates , @-@ @ mL/s ) were randomized to either an @-gauge nonfenestrated or @-gauge fenestrated catheter .


After randomization , any @-gauge nonfenestrated subjects whose veins were deemed insufficient for that catheter gauge were assigned to a third cohort for placement of a @-gauge fenestrated catheter .


Catheter placement success , infusion rate , contrast volume , maximum pressure , complications , and aortic enhancement levels were recorded .


Catheters were placed on the first attempt in @ % ( @/@ ) for @-gauge nonfenestrated and @ % ( @/@ ) for @-gauge fenestrated placements and in two or fewer attempts in @ % of both groups .


Mean infusion rates ( @ mL/s for @-gauge nonfenestrated and @ mL/s for @-gauge fenestrated placements ) and aortic enhancement levels were not significantly different .


Maximum pressure was higher with @-gauge fenestrated catheters ( mean SD , @ @ pounds per square inch -LSB- psi -RSB- ) than @-gauge nonfenestrated catheters ( mean SD @ @ psi ) ( p = @ ) .


One subject with an @-gauge nonfenestrated catheter had a high-pressure alarm .


In the third cohort , a @-gauge fenestrated catheter was successfully placed in two or fewer attempts in @ % ( @/@ ) , with one minor extravasation attributed to vein insufficiency .


A @-gauge fenestrated catheter performs similarly to an @-gauge nonfenestrated catheter with respect to i.v. contrast infusion rates and aortic enhancement levels and can be placed in most subjects whose veins are deemed insufficient for an @-gauge catheter .


Patient blood management is introduced as a new concept that involves the combined use of transfusion alternatives .


In elective adult total hip - or knee-replacement surgery patients , the authors conducted a large randomized study on the integrated use of erythropoietin , cell saver , and/or postoperative drain reinfusion devices ( DRAIN ) to evaluate allogeneic erythrocyte use , while applying a restrictive transfusion threshold .


Patients with a preoperative hemoglobin level greater than @ g/dl were ineligible for erythropoietin and evaluated for the effect of autologous blood reinfusion .


Patients were randomized between autologous reinfusion by cell saver or DRAIN or no blood salvage device .


Primary outcomes were mean intra - and postoperative erythrocyte use and proportion of transfused patients ( transfusion rate ) .


Secondary outcome was cost-effectiveness .


In @,@ evaluated total hip - and knee-replacement surgery patients , the mean erythrocyte use was @ ( SD , @ ) erythrocyte units/patient in the autologous group ( n = @,@ ) and @ ( @ ) erythrocyte units/patient in the control group ( n = @ ) ( P = @ ) .


The transfusion rate was @ % in the autologous group compared with @ % in the control group ( P = @ ) .


No difference in erythrocyte use was found between cell saver and DRAIN groups .


Costs were increased by @ per patient ( @ % CI , @ to @ ) .


In patients with preoperative hemoglobin levels greater than @ g/dl , autologous intra - and postoperative blood salvage devices were not effective as transfusion alternatives : use of these devices did not reduce erythrocyte use and increased costs .


Patient chart review is the gold standard for detection of potential patient hazards ( i.e. medication errors or failure to follow up actionable results ) in both routine clinical care and patient safety research .


However , advanced medical students ' ability to read patient charts and to identify patient hazards is rather poor .


We therefore investigated whether it is possible to teach advanced medical students how to identify patient hazards independent of context ( i.e. cancer versus cardiac failure ) in patient charts .


All fifth-year medical students in one semester ( n = @ ) were randomized into two groups .


One group ( IC ) received a patient chart review-training first and then a control-intervention and the other group ( CI ) received the control-intervention first and then the patient chart review-training .


Before and after the teaching sessions , students reviewed different scenarios with standardized fictional patient charts containing @ common patient hazards .


Two blinded raters rated the students ' notes for any patient hazard addressed in the notes using a checklist .


The students were blinded to the study question and design .


There was no external funding and no harm for the participating students .


A total of @ data sets had to be excluded because of missing data .


Overall , the students identified @ % ( IQR @-@ % ) of the patient hazards before the training and @ % ( IQR @-@ % ) of the patient hazards after the training .


At the second assessment students identified more patient hazards than at the first .


They identified even more in the third .


The effect was most pronounced after the patient chart review training ( all p < @ ) .


Patient chart review exercises and problem-based patient chart review training improve students ' abilities to recognize patient hazards independent of context during patient chart review .


To investigate homoarginine and asymmetric dimethylarginine ( ADMA ) in controls compared to children with type @ diabetes ( T@D ) and if homoarginine and ADMA are affected by atorvastatin .


Homoarginine and ADMA levels of @ T@D patients were compared to levels of @ controls .


In T@D patients , homoarginine and ADMA were determined at baseline , @ year , and @ years at daily @ mg atorvastatin or placebo within a double-blind study .


At baseline , both homoarginine and ADMA were lower ( p < @ ) in T@D patients compared to controls .


In T@D patients , homoarginine and ADMA were not influenced by atorvastatin .


Inverse correlations between homoarginine and HbA@c ( p < @ ) and between ADMA and systolic blood pressure ( p = @ ) and pulse pressure ( p = @ ) were shown .


Homoarginine and ADMA levels are decreased and associated with cardiovascular risk factors in children with T@D without being affected by atorvastatin .


To evaluate the effect of note-taking skills training on the achievement motivation in learning .


The experimental study comprised graduate students of the @-@ batch at Kerman 's Bahonar University and Kerman 's Medical Sciences University , Iran .


The study sample included @ people ; @ in the test group , and @ in the control group .


They were randomly selected and replaced through the single-stage cluster sampling .


To collect the data , a questionnaire was used .


Pre-test was performed before the training session in two groups .


After training course , a post-test was taken .


For data analysis , the independent t-test , was used .


The average pre-test score of the test group was @ + / - @ , while for the control group it was @ + / - @ ( p < @ ) .


After the training , the post-test showed statistically significant change .


The test group scored @ + / - @ against the controls who scored @ + / - @ ( p < @ ) .


The findings showed that achievement motivation in learning increased significantly after imparting training in note-taking skills .


Authorities in the educational system should invest more for promotion of such skills .


The present clinical trial was designed to investigate the effectiveness of subgingivally delivered satranidazole ( SZ ) gel as an adjunct to scaling and root planing ( SRP ) in the treatment of chronic periodontitis .


Sixty-four subjects with probing depth ( PD ) @ mm and who were diagnosed with type @ diabetes were selected .


Thirty-two subjects each were randomly assigned to SRP + placebo ( Group @ ) and SRP + SZ ( Group @ ) .


The clinical outcomes evaluated were plaque index ( PI ) , gingival index ( GI ) , clinical attachment level ( CAL ) and PD at baseline , @ month , @-months and @ months .


At @ months , Group @ had greater mean reduction ( @ mm ) in PD as compared to Group @ ( @ mm ; p < @ ) and also a greater mean CAL gain ( @ mm versus @ mm ; p < @ ) .


The use of @ % SZ gel , when used as an adjunct to non-surgical periodontal therapy in subjects with periodontitis , achieves significantly better clinical results than initial periodontal treatment alone .


Although highly porous metals have demonstrated excellent bone ingrowth properties and so are an intriguing option for fixation in total knee arthroplasty ( TKA ) , some surgeons are skeptical about the durability of uncemented tibial fixation and the potential for soft tissues to adhere to these porous metals and perhaps cause knee stiffness or pain .


The purpose of this study was to compare , in the context of a randomized clinical trial , a highly porous metal tibia compared with a traditional modular cemented tibia in terms of survivorship , Knee Society scores , range of motion ( ROM ) , and complications .


From @ to @ , @ patients ( age @ years ; @ % female ) were randomized to three groups : ( @ ) traditional modular cemented tibia ; ( @ ) cemented highly porous metal tibia ; and ( @ ) uncemented highly porous metal tibia .


The same posterior-stabilized femoral component and patella component were cemented in every case .


Stratified randomization was done for surgeon , patient 's age , sex , and body mass index .


Survivorship at @years was compared between the groups , as were Knee Society scores , ROM , and complications .


Radiographic assessment included alignment , radiolucency , and implant migration/loosening .


Patients were followed until death , revision , or for a minimum of @years ( mean , @years ; range , @-@years ) .


Four patients were lost to followup before @years .


Highly porous metal tibias ( both uncemented and cemented ) were no different from traditional cemented modular tibial modular components in terms of survivorship at @years using a intention-to-treat analysis ( @ % -LSB- @ -RSB- ; @ % -LSB- @ -RSB- ; @ % -LSB- @ -RSB- ; p = @ ) .


A per-protocol analysis revealed that no highly porous metal tibia was revised for aseptic loosening .


Highly porous metal tibias performed comparably to traditional cemented modular tibias in terms of Knee Society scores , ROM , and the frequency of complications .


At @years this randomized clinical trial demonstrated that highly porous metal tibias provided comparably durable fixation and reliable pain relief and restoration of function when compared with a traditional cemented modular tibia in TKA .


Level I , therapeutic study .


See Guidelines for Authors for a complete description of levels of evidence .


In The Netherlands , screening for chlamydia ( the most prevalent sexually transmitted infection worldwide ) is a relatively simple and free procedure .


Via an invitation letter sent by the public health services ( PHS ) , people are asked to visit a website to request a test kit .


They can then do a chlamydia test at home , send it anonymously to a laboratory , and , within two weeks , they can review their test results online and be treated by their general practitioner or the PHS .


Unfortunately , the participation rates are low and the process is believed to be not ( cost - ) effective .


The objective of this study was to assess whether the low participation rate of screening for chlamydia at home , via an invitation letter asking to visit a website and request a test kit , could be improved by optimizing the invitation letter through systematically applied behavior change theories and evidence .


The original letter and a revised letter were randomly sent out to @,@ citizens , @ to @ years old , in a Dutch municipality .


Using behavior change theories , the revised letter sought to increase motivation to conduct chlamydia screening tests .


The revised letter was tailored to beliefs that were found in earlier studies : risk perception , advantages and disadvantages ( attitude ) , moral norm , social influence , and response - and self-efficacy .


Revisions to the new letter also sought to avoid possible unwanted resistance caused when people feel pressured , and included prompts to trigger the desired behavior .


No significant differences in test package requests were found between the two letters .


There were also no differences between the original and revised letters in the rates of returned tests ( @ % , @/@ vs. @ % , @/@ ) or positive test results ( @ % , @/@ vs. @ % , @/@ ) .


It is evident that the new letter did not improve participation compared to the original letter .


It is clear that the approach of inviting the target population through a letter does not lead to higher participation rates for chlamydia screening .


Other approaches have to be developed and pilot tested .


This study was designed to compare two approaches to negative-pressure wound therapy : @-mmHg pressure with a polyurethane foam dressing and @-mmHg pressure with a silicone-coated dressing .


Forty patients with diabetic foot wounds , after incision and drainage or amputation for infection , were assigned randomly to negative-pressure wound therapy with @-mmHg continuous pressure with a silicone-covered dressing ( @-mmHg group ) or @-mmHg with a polyurethane foam dressing ( @-mmHg group ) for up to @ weeks or until surgical closure .


There was no difference in the proportion of wounds that were closed surgically ( @-mmHg group , @ percent ; @-mmHg group , @ percent ) , wounds that demonstrated @ percent wound area reduction ( @-mmHg group , @ percent ; @-mmHg group , @ percent ) , or wounds that demonstrated @ percent wound volume reduction after @ weeks of therapy ( @-mmHg group , @ percent ; @-mmHg group , @ percent ) .


The authors ' results suggest that there was no difference in outcomes in wounds treated with low pressure ( @ mmHg ) with a silicone-coated interface and high pressure ( @ mmHg ) with a polyurethane foam interface .


Therapeutic , II .


In the AVAGAST study , fluoropyrimidine and cisplatin plus bevacizumab did not significantly improve overall survival ( OS ) versus fluoropyrimidine and cisplatin plus placebo in patients with advanced gastric cancer .


Geographic differences in efficacy were observed in AVAGAST , but the study only included @ Chinese patients .


AVATAR , a study similar in design to AVAGAST , was a randomized , double-blind , phase III study conducted in Chinese patients with advanced gastric cancer .


Patients more than @ years of age with gastric adenocarcinoma were randomized @:@ to capecitabine-cisplatin plus either bevacizumab or placebo .


The primary endpoint was OS ; secondary endpoints included progression-free survival ( PFS ) and safety .


In total , @ patients were included ( placebo n = @ ; bevacizumab n = @ ) .


Baseline characteristics were well balanced .


The primary analysis result did not show a difference in OS for the bevacizumab arm compared to the placebo arm -LSB- hazard ratio , @ ( @ % CI , @-@ @ ) ; P = @ -RSB- .


Median PFS was also similar in both arms .


Bevacizumab plus capecitabine-cisplatin was well tolerated .


Grade @-@ adverse events ( AEs ) occurred in @ % of bevacizumab-treated and @ % of placebo-treated patients , respectively .


Grade @-@ AEs of special interest with bevacizumab occurred in @ % of bevacizumab-treated patients and @ % of placebo-treated patients , mainly grade @-@ hemorrhage ( bevacizumab @ % , placebo @ % ) .


Addition of bevacizumab to capecitabine-cisplatin in Chinese patients with advanced gastric cancer did not improve outcomes in AVATAR .


There was no difference in OS between the two arms and PFS was similar in both arms .


Safety findings were as previously experienced with bevacizumab , including AVAGAST ; no new safety signals were reported .


Excessive recreational screen time ( i.e. , screen use for entertainment ) is a global public health issue associated with adverse mental and physical health outcomes .


Considering the growing popularity of screen-based recreation in adolescents , there is a need to identify effective strategies for reducing screen time among adolescents .


The aim of this paper is to report the rationale and study protocol for the ` Switch-off @ Healthy Minds ' ( S@HM ) study , an intervention designed to reduce recreational screen time among adolescents .


The S@HM intervention will be evaluated using a cluster randomized controlled trial in eight secondary schools ( N = @ students ) in New South Wales , Australia .


The @-month multi-component intervention will encourage adolescents to manage their recreational screen time using a range of evidence-based strategies .


The intervention is grounded in Self-Determination Theory ( SDT ) and includes the following components : an interactive seminar for students , eHealth messaging , behavioral contract and parental newsletters .


All outcomes will be assessed at baseline and at @-months ( i.e. , immediate post-test ) .


The primary outcome is recreational screen time measured by the Adolescent Sedentary Activity Questionnaire ( ASAQ ) .


Secondary outcomes include : self-reported psychological well-being , psychological distress , global physical self-concept , resilience , pathological video gaming and aggression , and objectively measured physical activity ( accelerometry ) and body mass index ( BMI ) .


Hypothesized mediators of behavior change will also be explored .


The S@HM study will involve the evaluation of an innovative , theory-driven , multi-component intervention that targets students and their parents and is designed to reduce recreational screen time in adolescents .


The intervention has been designed for scalability and dissemination across Australian secondary schools .


Estimates show that as many as one in @ patients are harmed while receiving hospital care .


Previous strategies to improve safety have focused on developing incident reporting systems and changing systems of care and professional behaviour , with little involvement of patients .


The need to engage with patients about the quality and safety of their care has never been more evident with recent high profile reviews of poor hospital care all emphasising the need to develop and support better systems for capturing and responding to the patient perspective on their care .


Over the past @ years , our research team have developed , tested and refined the PRASE ( Patient Reporting and Action for a Safe Environment ) intervention , which gains patient feedback about quality and safety on hospital wards .


A multi-centre , cluster , wait list design , randomised controlled trial with an embedded qualitative process evaluation .


The aim is to assess the efficacy of the PRASE intervention , in achieving patient safety improvements over a @-month period.The trial will take place across @ hospital wards in three NHS Hospital Trusts in the North of England .


The PRASE intervention comprises two tools : ( @ ) a @-item questionnaire which asks patients about safety concerns and issues ; and ( @ ) a proforma for patients to report ( a ) any specific patient safety incidents they have been involved in or witnessed and ( b ) any positive experiences .


These two tools then provide data which are fed back to wards in a structured feedback report .


Using this report , ward staff are asked to hold action planning meetings ( APMs ) in order to action plan , then implement their plans in line with the issues raised by patients in order to improve patient safety and the patient experience.The trial will be subjected to a rigorous qualitative process evaluation which will enable interpretation of the trial results .


fieldworker diaries , ethnographic observation of APMs , structured interviews with APM lead and collection of key data about intervention wards .


Intervention fidelity will be assessed primarily by adherence to the intervention via scoring based on an adapted framework .


This study will be one of the largest patient safety trials ever conducted , involving @ hospital wards .


The results will further understanding about how patient feedback on the safety of care can be used to improve safety at a ward level .


Incorporating the ` patient voice ' is critical if patient feedback is to be situated as an integral part of patient safety improvements .


We aim to obtain the intra-subject coefficient of variability of a highly variable antidepressant agomelatine in humans , and propose an adjusted bioequivalence assessment strategy .


A single-dose , randomized crossover design was conducted in four periods ( reference administered thrice , placebo administered once ) separated by seven days .


A validated LC-MS/MS assay was used to measure drug concentrations in serial blood samples .


The intra-subject coefficient of variability was calculated using the residual variance of ANOVA analysis , and the results for Cmax and AUC@-t was @ % and @ % , respectively , in Chinese healthy subjects .


The sample size required for standard BE study were @ ( @ , @ ) if the expected deviation between the reference and generic products was set to @ ( @ % , @ % ) .


Agomelatine meets the criteria for highly variable drug in Chinese healthy male subjects , and the traditional BE criteria for agomelatine needs to be adjusted to alleviate the resource and ethical burden of using a large numbers of subjects in clinical trials .


Our clinical data on the intra-subject variability of agomelatine PK in Chinese healthy population enables to adjust bioequivalence ( BE ) assessment approach for agomelatine based on the RSABE approaches recommended by regulatory agencies .


Impairment of HDL function has been associated with cardiovascular events in patients with kidney failure .


The protein composition of HDLs is altered in these patients , presumably compromising the cardioprotective effects of HDLs .


This post hoc study assessed the relation of distinct HDL-bound proteins with cardiovascular outcomes in a dialysis population .


The concentrations of HDL-associated serum amyloid A ( SAA ) and surfactant protein B ( SP-B ) were measured in @ patients with type @ diabetes mellitus on hemodialysis participating in The German Diabetes Dialysis Study who were randomly assigned to double-blind treatment of @ mg atorvastatin daily or matching placebo .


The association of SAA ( HDL ) and SP-B ( HDL ) with cardiovascular outcomes was assessed in multivariate regression models adjusted for known clinical risk factors .


High concentrations of SAA ( HDL ) were significantly and positively associated with the risk of cardiac events ( hazard ratio per @ SD higher , @ ; @ % confidence interval , @ to @ ) .


High concentrations of SP-B ( HDL ) were significantly associated with all-cause mortality ( hazard ratio per @ SD higher , @ ; @ % confidence interval , @ to @ ) .


Adjustment for HDL cholesterol did not affect these associations .


In patients with diabetes on hemodialysis , SAA ( HDL ) and SP-B ( HDL ) were related to cardiac events and all-cause mortality , respectively , and they were independent of HDL cholesterol .


These findings indicate that a remodeling of the HDL proteome was associated with a higher risk for cardiovascular events and mortality in patients with ESRD .


To assess the effects of different frequencies of thalamic Deep-Brain-Stimulation ( DBS ) on cognitive performance of patients suffering from Essential Tremor ( ET ) .


In @ ET-patients with thalamic-DBS , Tremor-Rating-Scale ( TRS ) , standardized phonemic and semantic verbal fluency ( VF ) , Stroop-Color-Word-Test and Digit-span-test were investigated in three randomized stimulation-settings : i ) high-frequency stimulation ( HFS ) , ii ) low-frequency stimulation ( LFS ) and iii ) OFF-stimulation ( DBS-OFF ) .


Paired-samples t-test for TRS and one-way repeated measures analysis of variance for cognitive performance were calculated .


Tremor was reduced during HFS ( MeanTRS-HFS = @ @ ) compared to DBS-OFF ( MeanTRS-OFF = @ @ , P < @ ) and to LFS ( MeanTRS-@ Hz = @ @ ; P < @ ) .


While performance of Stroop-task and digit-span remained unaffected by stimulation-settings ( P > @ ) , phonemic and semantic VF differed significantly between the three conditions ( FPvf = @ , FSvf = @ , both P < @ ) .


Post-hoc comparisons revealed significant differences for both phonemic and semantic VF between LFS ( MeanPvf-@ Hz = @ @ , MeanSvf-@ Hz = @ @ ) and HFS ( MeanPvf-ON = @ @ , MeanSvf-ON = @ @ , both P < @ ) , while DBS-OFF ( MeanPvf-OFF = @ @ , MeanSvf-OFF = @ @ ) and HFS and DBS-OFF and LFS did not differ significantly ( P > @ ) .


HFS compared to LFS or DBS-OFF significantly reduced tremor but simultaneously worsened VF while working memory and cognitive inhibition remained unaffected .


In contrast , LFS enhanced VF but did not ameliorate tremor .


The data emphasize the relevance of thalamocortical loops for verbal fluency but also suggest that more sophisticated DBS-regimes in ET may improve both motor and cognitive performance .


Previous findings suggest that language disorders may occur in severely brain-injured patients and could interfere with behavioral assessments of consciousness .


However , no study investigated to what extent language impairment could affect patients ' behavioral responses .


Objective .


To estimate the impact of receptive and/or productive language impairments on consciousness assessment .


Twenty-four acute and subacute stroke patients with different types of aphasia ( global , n = @ ; Broca , n = @ ; Wernicke , n = @ ; anomic , n = @ ; mixed , n = @ ) were recruited in neurology and neurosurgery units as well as in rehabilitation centers .


The Coma Recovery Scale-Revised ( CRS-R ) was administered .


We observed that @ % ( @ out of @ ) of stroke patients with a diagnosis of aphasia and @ % ( @ out of @ ) of patients with a diagnosis of global aphasia did not reach the maximal CRS-R total score of @ .


An underestimation of the consciousness level was observed in @ patients with global aphasia who could have been misdiagnosed as being in a minimally conscious state , even in the absence of any documented period of coma .


More precisely , lower subscores were observed on the communication , motor , oromotor , and arousal subscales .


Consciousness assessment may be complicated by the co-occurrence of severe language deficits .


This stresses the importance of developing new tools or identifying items in existing scales , which may allow the detection of language impairment in severely brain-injured patients .


Prenatal consumption of omega-@ fatty acids can act as an adjuvant in the development of the immune system and affect the inflammatory response of neonates .


We conducted a double-blind , randomized , placebo-controlled trial in Cuernavaca , Mexico .


We randomly assigned @,@ pregnant women ( @-@ years of age ) to receive @ mg/d of algal docosahexaenoic acid ( DHA ) or placebo from @ to @ weeks of gestation through delivery .


Birth outcomes and respiratory symptoms information until @ months were available for @ mother-child pairs .


Questionnaires were administered , and maternal blood samples were obtained at baseline .


Maternal atopy was based on specific IgE levels .


During follow-up , information on infants ' respiratory symptoms was collected through questionnaires administered at @ , @ , @ , @ , @ , and @ months of age .


Negative binomial regression models were used to evaluate the effect of supplementation on respiratory symptoms in infants .


Among infants of atopic mothers , a statistically significant protective effect of DHA treatment was observed on phlegm with nasal discharge or nasal congestion ( @ ; @ % CI , @-@ @ ) and fever with phlegm and nasal discharge or nasal congestion ( @ ; @ % CI , @-@ @ ) , adjusting for potential confounders .


Our results support the hypothesis that DHA supplementation during pregnancy may decrease the incidence of respiratory symptoms in children with a history of maternal atopy .


Physical activity ( PA ) predicts cardiovascular mortality in the population at large .


Less is known about its prognostic value in patients with chronic heart failure ( HF ) .


Data from @ patients with implantable cardioverter defibrillator without or with cardiac resynchronization therapy enrolled in the Sensitivity of the InSync Sentry OptiVol feature for the prediction of Heart Failure ( SENSE-HF ) ( @ ) study and the Diagnostic Outcome Trial in Heart Failure ( DOT-HF ) were pooled .


The devices continuously measured and stored total daily active time ( single-axis accelerometer ) .


Early PA ( average daily activity over the earliest @-day study period ) was studied as a predictor of time to death or HF-related hospital admission ( primary end point ) .


Data from @ patients were analyzed ( @ years ; @ % men ; left ventricular ejection fraction , @ % ) .


Older age , shorter height , ischemic cause , peripheral artery disease , atrial fibrillation , diabetes mellitus , rales , peripheral edema , higher New York Heart Association class , lower diastolic blood pressure , and no angiotensin II receptor blocker/angiotensin-converting enzyme inhibitor use were associated with reduced early PA. .


The primary end point occurred in @ patients ( @ months of follow-up ) .


In multivariable analysis including baseline variables , early PA predicted death or HF hospitalization , with a @ % reduction in risk for each @ minutes per day additional activity ( hazard ratio -LSB- HR -RSB- , @ ; confidence interval -LSB- CI -RSB- , @-@ @ ; P = @ compared with a model with the same baseline variables but without PA ) .


PA also predicted death ( HR , @ ; CI , @-@ @ ; P < @ ) and HF hospitalization ( HR , @ ; CI , @-@ @ ; P = @ ) .


Early PA , averaged over a @-day window early after defibrillator implantation or cardiac resynchronization therapy in patients with chronic HF , predicted death or HF hospitalization , as well as mortality and HF hospitalization separately , accounting for baseline HF severity .


Clinical Trial Registration Information - URL : http://www.clinicaltrials.gov .


Unique identifiers : NCT@ , NCT@ .


To comprehensively evaluate the effect of a short-term diabetes self-management education ( DSME ) on metabolic markers and atherosclerotic parameters in patients with type @ diabetes .


@ patients with type @ diabetes were recruited in this study .


They were divided into the intervention group ( n = @ ) and control group ( n = @ ) .


The patients in the intervention group received a @-month intervention , including an @-week education on self-management of diabetes mellitus and subsequent @ weeks of practice of the self-management guidelines .


The patients in the control group received standard advice on medical nutrition therapy .


Metabolic markers , carotid intima-media thickness ( CIMT ) , and carotid arterial stiffness ( CAS ) of the patients in both groups were assessed before and after the @-month intervention .


There was a significant reduction in hemoglobin A@c ( HbA@c , -@ @ % versus @ @ % ; P < @ ) and body weight ( -@ @ kg versus -@ @ kg ; P < @ ) in the intervention group as compared to the control group .


However , no significant improvements were found in other metabolic markers , CIMT and CAS ( P > @ ) .


DSME can improve HbA@c and body weight in patients with type @ diabetes .


To compare anterior chamber paracentesis ( ACP ) with standard medical management of acute primary angle closure ( APAC ) .


Prospective study .


Patients with APAC and intraocular pressure ( IOP ) @ mm Hg were enrolled .


Patients were randomized to receive ACP and medical treatment ( group @ ) or medical management alone ( group @ ) .


There were @ patients ( mean age @ @ years , @ eyes ) in group @ and @ patients ( mean age @ @ years , @ eyes ) in group @ .


The IOP in group @ was significantly lower at @ minutes , @ minutes , and @ hour after treatment ( p < @ ) .


At @ , @ , and @ hours after treatment , visual acuity was significantly better in group @ than in group @ .


At each time point after treatment , the grade of corneal edema was not different between the groups .


Pain score at @ and @ hours after treatment was significantly lower in group @ than in group @ ; however , no difference was noted at @ hours after treatment .


The mean follow-up period in group @ was @ @ months and in group @ was @ @ months ( p = @ ) .


At last follow-up , IOP , pupil size , number of eyes with nonreactive pupils , and centre endothelial cell counts were not different ; however , visual acuity was significantly better in group @ ( @ @ logMAR vs @ @ logMAR , p = @ ) .


Immediate ACP is a safe and effective for rapidly lowering IOP , and is associated with better visual acuity than medical treatment alone .


Bone fracture is a common cause of acute pain in emergency and orthopedics departments .


Targeting the multifaceted mechanisms of pain with combinations of multiple analgesics ( multimodal analgesia ) can increase the pain control efforts efficacy and decrease the adverse effects of each medication .


One hundred and fifty-three patients with acute bone fracture were randomly allocated to two groups receiving intravenous morphine sulfate ( @ patients ) or oral oxycodone plus intravenous acetaminophen ( @ patients ) .


Pain scores and drugs ' adverse effects were assessed @ , @ and @ min after treatment .


Pain scores were similar between groups before , @ and @ min after medication but patients in morphine sulfate group experienced less pain @ min after medication .


Eight ( @ % ) patients in morphine sulfate group and @ ( @ % ) patients in acetaminophen/oxycodone group experienced nausea that was statistically significant higher ( P value = @ ) .


Itching was seen in @ ( @ % ) patients of acetaminophen/oxycodone group and three ( @ % ) patients of patients in morphine sulfate group ( P value = @ ) .


Intravenous acetaminophen plus oral oxycodone is as effective as intravenous morphine sulfate in acute pain control in emergency department but with a less desirable safety profile .


Salacia oblonga , Tinospora cordifolia , Emblica offinalis Gaertn , Curcuma longa and Gymnema sylvestre are Ayurvedic medicinal plants reported to lower plasma glucose levels in animal models .


To our knowledge , however , no clinical validations of those extracts for efficacy have been .


The aim of this study was to evaluate the effect of polyherbal combination in patients with type @ diabetes mellitus .


We screened @ patients enrolled in a diabetes mellitus screening camp held at District Ayurvedic Hospital , Kottayam , Kerala , India .


Of these , @ patients diagnosed with type @ diabetes mellitus and @ healthy volunteers of similar age group were included in the study .


Patients were treated with a polyherbal combination drug namely G-@ ( @ mg/d ) for @ wk with a follow-up of @wk interval .


Fasting and postprandial blood glucose levels measured after @ wk of G-@ treatment in patients were significantly lower .


Indeed diabetic rats showed similar protection with G-@ administration .


Furthermore , glycosylated hemoglobin , serum total cholesterol , both high - and low-density lipoprotein cholesterol , and triglycerides showed a significant improvement in G-@-administered patients .


Toxicologic profile of the drug was assessed by analyzing the enzyme activities of alkaline phosphatase and alanine aminotransferase along with the concentration of blood urea nitrogen and creatinine in blood and found insignificant change compared with control .


Short-term supplementation of G-@ not only attenuates the hyperglycemia , but also acts as hypolipidemic agent in patients with diabetes .


Further study should be done for the long-term effect of the drug in larger populations .


To study therapeutic effects of comprehensive traditional Chinese medicine therapy for preventing postsurgery stiffness after operation for terrible triad of the elbow .


From December @ to December @,@ patients with elbow triad were randomly divided into two groups : therapy group and control group .


There were @ patients in control group including @ males and @ females with a mean age of ( @ @ ) years old .


The patients in control group were received the past procedure therapy .


There were @ patients in therapy group , including @ males and @ females with a mean age of ( @ @ ) years old .


The patients in therapy group were received comprehensive traditional Chinese medicine therapy , including passive exercise training at early stage ( @ to @ weeks after operation ) , transition from passive to active exercise training at middle stage ( @ to @ weeks after operation ) , and active exercise training at late stage ( @ to @ weeks after operation ) .


Other treatment methods , such as orally taking or externally use of Chinese herbal medicine , manipulation and physiotherapy , were used at all stages .


The Mayo Elbow Performance Score , patient satisfaction and complications were evaluated and analyzed .


All the patients were followed up , and the mean duration was @ months .


There were no complications such as internal fixation loosing , obvious displacement fracture and heterotopic ossification occurred .


The Mayo score and patient satisfaction in therapy group were higher than those in control group ( t = @ , P = @ ; @ = @ , P = @ ) .


Seven patients needed reoperation in control group , compared with @ patient in therapy group ( @ = @ , P = @ ) .


The comprehensive traditional Chinese medicine therapy is effective to prevent postoperative stiffness after operation for terrible triad of the elbow by using different methods at different stages , which is worthy of spread and application .


The purpose of this study was to assess the repeatability of water-fat MRI and diffusion-tensor imaging ( DTI ) as quantitative biomarkers of pediatric lower extremity skeletal muscle .


MRI at @ T of a randomly selected thigh and lower leg of seven healthy children was studied using water-fat separation and DTI techniques .


Muscle-fat fraction , apparent diffusion coefficient ( ADC ) , and fractional anisotropy ( FA ) values were calculated .


Test-retest and interrater repeatability were assessed by calculating the Pearson correlation coefficient , intraclass correlation coefficient , and Bland-Altman analysis .


Bland-Altman plots show that the mean difference between test-retest and interrater measurements of muscle-fat fraction , ADC , and FA was near @ .


The correlation coefficients and intraclass correlation coefficients were all between @ and @ ( p < @ ) , suggesting excellent reliability of the measurements .


Muscle-fat fraction measurements from water-fat MRI exhibited the highest intraclass correlation coefficient .


Interrater agreement was consistently better than test-retest comparisons .


Water-fat MRI and DTI measurements in lower extremity skeletal muscles are objective repeatable biomarkers in children .


This knowledge should aid in the understanding of the number of participants needed in clinical trials when using these determinations as an outcome measure to noninvasively monitor neuromuscular disease .


As new techniques emerge to quantify patients ' health status , new opportunities are created to validate patient-reported outcome questionnaires .


The Seattle Angina Questionnaire ( SAQ ) , a widely used coronary artery disease-specific health status tool , has not been validated against daily records of angina frequency and sublingual nitroglycerin ( SL NTG ) use .


Additional evidence supporting the validity of the SAQ could justify its broader use as an outcome for clinical studies designed to evaluate treatments that may improve patients ' symptoms , function , and quality of life .


We used data from @ patients with type @ diabetes mellitus , coronary artery disease , and stable angina from the multinational Type @ Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina ( TERISA ) trial .


The number of angina episodes and SL NTG used were recorded and transmitted daily using an electronic diary .


In cross-sectional analyses , there was a strong relationship between the @ SAQ angina frequency questions ( ie , frequency of angina and SL NTG use ) and the corresponding diary responses , with correlation coefficients of -@ for angina frequency ( @ % confidence interval,-@ @ to -@ ) and -@ for SL NTG use ( @ % confidence interval , -@ to -@ ) .


Longitudinally , changes in SAQ angina frequency scores from day @ to week @ also correlated with changes in angina frequency ( -@ ; @ % confidence interval , -@ to -@ ) and SL NTG use by diary ( -@ ; @ % confidence interval , -@ to -@ ) over the corresponding time period .


Correlations were similar when stratified by age , sex , or geography .


In a multinational cohort of patients with stable angina , the SAQ angina frequency domain was significantly correlated , both cross sectionally and longitudinally , with daily diary entries of angina frequency and SL NTG use .


These data further support the validity of the SAQ angina frequency domain across a broad spectrum of patients with stable angina .


To observe the change of intra-abdominal pressure ( IAP ) in severe acute pancreatitis ( SAP ) patients , and to study the effect of Qingyi Chengqi Decoction ( QCD ) on it .


Eighty-six SAP patients from Department of General Surgery and Department of Digestive Diseases , Qingyang People 's Hospital , Gansu Province , who were in line with diagnosis standard of SAP , were assigned to the treatment group ( @ cases ) and the control group ( @ cases ) from March @ to May @ .


All patients received routine Western medicine .


Those in the treatment group took QCD additionally .


Main clinical symptoms and APACHE II were observed .


The serum levels of amylase ( AMY ) , C-reactive protein ( CRP ) , and IAP were examined .


The incidence of secondary infection rate ( SIR ) , drainage rate ( percutaneous catheter drainage and operation ) , mortality , and mean days in ward were also recorded .


Main clinical symptoms were significantly improved in the treatment group .


APACHE II score , serum levels of AMY , CRP , and IAP obviously decreased in the treatment group .


The incidence of SIR , drainage rate , and the mortality were also significantly lower in the treatment group than in the control group .


The mean days in ward were also markedly shortened ( P < @ ) .


QCD could relieve inflammatory response , lower IAP , SIR , and mortality , increase the curative rate and improve the prognosis of SAP .


The incidence of postoperative pharyngolaryngeal complications after laryngeal mask airway ( LMA ) insertion can be as high as @ % .


Over-inflation of the LMA cuff may be a causal factor .


We conducted a single-centre parallel group randomised trial to determine whether maintaining LMA-ProSeal intra-cuff pressures below @ cm H@O decreases postoperative pharyngolaryngeal complications .


We recruited @ adult patients who were scheduled to undergo elective surgery under general anaesthesia .


Appropriate sized LMA-ProSeal was inserted and the cuff was inflated with air ( to no more than the maximum recommended volume ) until there was no audible leak .


Patients were randomised to either the control group ( n = @ ) , where the intra-cuff pressure was noted and no further action was taken , or to the pressure-monitored group ( n = @ ) , where intra-cuff pressure was maintained below @ cm H@O .


Pharyngolaryngeal complications consisting of sore throat , dysphonia and dysphagia were assessed at @ , @ , and @ h postoperatively .


Patients , anaesthesiologists and assessors were blinded to group allocation .


The primary outcome was a composite endpoint of any pharyngolaryngeal complication at any of the three time points .


Secondary outcomes were the incidence of individual outcomes at each time point .


The incidence of pharyngolaryngeal complications at any time point was @ % in the routine care group and @ % in the pressure-monitored group ( @ % CI for difference +@ to -@ % , p = @ ) .


There was no difference between groups for any of the secondary outcomes .


Our study failed to demonstrate a statistically significant reduction in postoperative pharyngolaryngeal complications by limiting intra-cuff pressures in the LMA-Proseal .


To evaluate canine erythrocyte concentrates ( ECs ) for the presence of procoagulant phospholipid ( PPL ) , determine whether PPL concentration changes during the course of storage of ECs , and ascertain whether prestorage leukoreduction ( removal of leukocytes via gravity filtration ) reduces the development of PPL .


@ whole blood units ( @ g each ) collected from @ random-source , clinically normal dogs ( @ U/dog ) .


The dogs were randomized to @ of @ groups .


Of the @ whole blood units collected , @ were processed through a standard method , and @ underwent leukoreduction .


Whole blood units were processed to generate ECs , from which aliquots were aseptically collected from each unit weekly for @ weeks .


Supernatants from the concentrates were evaluated for procoagulant activity , which was converted to PPL concentration , by use of an automated assay and by measurement of real-time thrombin generation .


Supernatants from stored canine ECs contained procoagulant activity as measured by both assays .


In general , the PPL concentration gradually increased during the storage period , but leukoreduction reduced the development of increased procoagulant activity over time .


The presence of PPL in canine ECs may be associated with procoagulant and proinflammatory effects in vivo , which could have adverse consequences for dogs treated with ECs .


Treatment of tobacco use in mental health settings is rare despite high rates of comorbidity .


With a focus on early intervention , we evaluated a tobacco treatment intervention among adolescents and young adults recruited from outpatient , school-based , and residential mental health settings and tested for gender differences .


Intervention participants received computerized motivational feedback at baseline , @ months , and @ months and were offered @ weeks of cessation counseling and nicotine patches .


Usual care participants received a self-help guide and brief cessation advice .


We examined @-day point prevalence abstinence with biochemical confirmation at @ , @ , and @ months ; smoking reduction ; and @-hr quit attempts .


At baseline , the sample ( N = @ , @ % female , mean age = @ years , @ % non-Hispanic Caucasian ) averaged @ cigarettes/day , @ % smoked daily , @ % smoked @ min of waking , @ % intended to quit in the next month , @ % had a parent who smoked , and @ of @ of participants ' closest friends smoked on average .


During the @-month study , @ % of the sample reduced their smoking , @ % quit for @ hr , and @ % , @ % , and @ % confirmed @-day point prevalence abstinence at @ - , @ - , and @-month follow-up , respectively , with no differences by treatment condition ( ps > @ ) .


Over time , abstinence was greater among girls ( adjusted odds ratio -LSB- AOR -RSB- = @ ) than among boys , and abstinence was greater for lighter smokers than heavier smokers ( AOR = @ ) ( p < @ ) .


No mental health or other measured variables predicted abstinence .


Adolescent and young adult smokers with mental health concerns are a challenging group to engage and to effectively treat for tobacco addiction , particularly heavier smokers and boys .


Innovative approaches are needed .


Limited pharmacological options are available for the management of Alzheimer 's disease ( AD ) in severe stages .


Cognitive-enhancing properties of saffron , the dried stigma of Crocus sativus L. , have been evidenced in different studies .


We aimed to compare the efficacy and safety of saffron extract versus memantine in reducing cognitive deterioration of patients with moderate to severe AD .


In this randomized double-blind parallel-group study , @ patients with moderate to severe AD ( Mini-Mental State Examination score of @-@ ) received memantine ( @mg/day ) or saffron extract ( @mg/day ) capsules for @months .


Participants were evaluated every month by Severe Cognitive Impairment Rating Scale ( SCIRS ) and Functional Assessment Staging ( FAST ) in addition to recording the probable adverse events .


Both treatment groups showed similar outcomes as demonstrated by insignificant effect for timetreatment interaction on SCIRS scores -LSB- F ( @ , @ ) = @ , p = @ -RSB- .


There was no significant difference between the two groups in the scores changes from baseline to the endpoint on SCIRS ( p = @ ) and FAST ( p = @ ) .


The frequency of adverse events was not significantly different between the two groups as well .


In addition to its favorable safety profile , @-year administration of saffron extract capsules showed to be comparable with memantine in reducing cognitive decline in patients with moderate to severe AD .


Confirmatory studies with larger sample sizes and longer follow-up periods are warranted .


NT-pro-BNP level is increased in both systolic and diastolic heart failure ( HF ) and furthermore increases more during exercise .


In diastolic HF , NT-pro-BNP might increase more during isometric exercise than during isotonic exercises because of increased afterload .


We studied NT-pro-BNP values during isometric ( hand-grip ) and isotonic ( cycloergometer ) exercise in HF patients with preserved left ventricular ejection fraction and different degrees of diastolic dysfunction .


We studied @ patients , aged @ @ years , @ % females , with heart failure with LVEF > @ % and diastolic dysfunction .


The patients were randomly distributed in two groups : @ patients ( Group I ) and @ patients ( Group II ) .


Group I underwent ramp exercise testing on a cycloergometer .


Group II performed an isometric handgrip test .


Plasma NT-pro-BNP levels were measured at rest and immediately after exercise .


An abnormal relaxation ( AR ) pattern was recorded in @ patients of Group I and @ patients of Group II .


Pseudonormalisation ( PSN ) and restrictive ( R ) pattern were noted in @ patients of each group .


As concerns Group I , NT-pro-BNP levels were increased in all patients , particularly in those with PSN or R pattern ( p < @ ) .


During exercise NT-pro-BNP decreases significantly in AR ( @ @ to @ @ pg/mL ) but not in PSN or R patients ( @ @ to @ @ pg/mL ) .


For Group II , NT-pro-BNP registered a similar increase as in Group I , with maximal values in PSN or R subgroup as compared to abnormal relaxation ( p < @ ) .


At peak exercise , NT-pro-BNP was practically unchanged as compared to the rest values for the whole group ( -@ % ) and for the two subgroups ( AR -@ % and PSN or R -@ % ) .


We compared rest and exercise NT-pro-BNP with E/E ' ratio > @ in order to identify increased diastolic filling pressure in the LV ; AUC was @ and @ for rest and exercise NT-pro-BNP in case of isotonic testing and @ and @ in case of isometric exercise .


Our data suggest that in HF patients with preserved left ventricular ejection fraction , moderate isotonic and isometric exercises do not determine a significant increase ( isometric exercise ) or even decrease ( isotonic exercise ) in the value of NT-pro-BNP .


Positively reinforcing properties of alcohol are in part mediated by activation of the ventral striatum ( VS ) .


Alcohol-induced release of endogenous opioids is thought to contribute to this response .


Preclinical studies show that the opioid antagonist naltrexone ( NTX ) can block this cascade , but its ability to do so in treatment-seeking alcoholics has not been examined .


Our objective was to study the effects of NTX on alcohol-induced VS activation and on amygdala response to affective stimuli in treatment-seeking alcohol-dependent inpatients .


Sixty-three treatment-seeking alcoholics were randomized to receive NTX ( @mg ) or placebo ( PLC ) daily .


On Day @ , participants underwent an alcohol cue reactivity session , and craving was measured using the Penn Alcohol Craving Scale .


On Day @ , participants received a saline infusion followed by an alcohol infusion and also viewed affective stimuli in a magnetic resonance scanner .


Irrespective of medication treatment condition , the alcohol infusion did not activate the VS in the alcohol-dependent patients .


Unexpectedly , VS activation was greater in NTX treated patients than in the PLC group .


NTX treated patients also reported increased craving in response to alcohol cue exposure , and increased subjective response to alcohol ( `` high '' and `` intoxicated '' ) compared to PLC subjects .


No significant effects of alcohol infusion on brain response to affective stimuli were in the NTX or PLC groups .


Unlike previous findings in social drinkers , a moderate level of intoxication did not activate the VS in treatment-seeking alcoholics .


This is likely to reflect tolerance to the positively reinforcing properties of alcohol in this clinical population .


Our findings may help explain the efficacy of NTX to reduce heavy drinking , but not to maintain abstinence .


Catechol-O-methyltransferase ( COMT ) metabolizes catecholamines in the prefrontal cortex ( PFC ) .


A common polymorphism in the COMT gene ( COMT val@met ) has pleiotropic effects on cognitive and emotional processing .


The met allele has been associated with enhanced cognitive processing but impaired emotional processing relative to the val allele .


We genotyped healthy , white men in relation to the COMT val@met polymorphism .


They were given a single @ mg dose of the selective noradrenaline reuptake inhibitor ( NRI ) reboxetine or placebo in a randomized , double-blind between-subjects model and then completed an emotional memory task @ hours later .


We included @ men in the study ; @ received reboxetine and @ received placebo .


In the placebo group , met/met carriers did not demonstrate the usual memory advantage for emotional stimuli that was observed in val carriers .


Reboxetine restored this emotional enhancement of memory in met/met carriers , but had no significant effect in val carriers .


We studied only men , thus limiting the generalizability of our findings .


We also relied on self-reported responses to screening questions to establish healthy volunteer status , and in spite of the double-blind design , participants were significantly better than chance at identifying their intervention allocation .


Emotional memory is impaired in healthy met homozygotes and selectively improved in this group by reboxetine .


This has potential translational implications for the use of reboxetine , which is currently licensed as an antidepressant in several countries , and edivoxetine , a new selective NRI currently in development .


Topical corticosteroids are used with systemic therapies for treatment of plaque psoriasis , but data from randomized clinical trials to document efficacy of combination therapy are lacking .


To evaluate efficacy and safety of adding topical corticosteroid therapy from the time that etanercept dosage is reduced from initial label dose -LSB- @ mg twice weekly ( BIW ) -RSB- to maintenance dose -LSB- @ mg once weekly ( QW ) -RSB- .


In this phase @b , multicentre , randomized , open-label study , patients with moderate-to-severe plaque psoriasis received etanercept @ mg BIW for @ weeks , and then were randomized to etanercept @ mg BIW or @ mg QW plus topical agent as needed to achieve static physician global assessment ( sPGA ) status of clear for @ weeks .


Endpoints included percentage change in Psoriasis Area and Severity Index ( PASI ) score from week @ to week @ ( primary endpoint ) ; proportion of patients achieving @ % improvement in ( PASI @ ) , PASI @ and PASI @ ; patients achieving sPGA of clear/almost clear ; and change in affected body surface area ( BSA ) .


Mean difference -LSB- @ % confidence interval ( CI ) -RSB- between etanercept arm ( n = @ ) and etanercept plus topical arm ( n = @ ) in change in PASI score from week @ to week @ was @ % ( -@ % , @ % ) .


PASI response rates were similar between groups .


Percentage ( @ % CI ) of patients achieving sPGA status of clear/almost clear was @ % ( @ % , @ % ) and @ % ( @ % , @ % ) at week @ for patients in etanercept and etanercept plus topical arms , respectively , and @ % ( @ % , @ % ) and @ % ( @ % , @ % ) at week @ .


Difference ( @ % CI ) between groups in change in affected BSA from week @ to week @ was @ % ( -@ % , @ % ) .


Patients who received etanercept @ mg QW at week @ plus as-needed topical therapy and those who stayed on etanercept @ mg BIW maintained clinical response through week @ with no notable differences in PASI responses .


Evidence about the efficacy of laparoscopic resection of rectal cancer is incomplete , particularly for patients with more advanced-stage disease .


To determine whether laparoscopic resection is noninferior to open resection , as determined by gross pathologic and histologic evaluation of the resected proctectomy specimen .


A multicenter , balanced , noninferiority , randomized trial enrolled patients between October @ and September @ .


The trial was conducted by credentialed surgeons from @ institutions in the United States and Canada .


A total of @ patients with clinical stage II or III rectal cancer within @ cm of the anal verge were randomized after completion of neoadjuvant therapy to laparoscopic or open resection .


Standard laparoscopic and open approaches were performed by the credentialed surgeons .


The primary outcome assessing efficacy was a composite of circumferential radial margin greater than @ mm , distal margin without tumor , and completeness of total mesorectal excision .


A @ % noninferiority margin was chosen according to clinical relevance estimation .


Two hundred forty patients with laparoscopic resection and @ with open resection were evaluable for analysis of the @ enrolled .


Successful resection occurred in @ % of laparoscopic resection cases ( @ % CI , @ % -@ % ) and @ % of open resection cases ( @ % CI , @ % -@ % ) and did not support noninferiority ( difference , -@ % ; @-sided @ % CI , -@ % to ; P for noninferiority = @ ) .


Patients underwent low anterior resection ( @ % ) or abdominoperineal resection ( @ % ) .


Conversion to open resection occurred in @ % of patients .


Operative time was significantly longer for laparoscopic resection ( mean , @ vs @ minutes ; mean difference , @ minutes ; @ % CI , @-@ @ ; P < @ ) .


Length of stay ( @ vs @ days ; mean difference , @ days ; @ % CI , -@ to @ ) , readmission within @ days ( @ % vs @ % ; difference , -@ % ; @ % CI , -@ % to @ % ) , and severe complications ( @ % vs @ % ; difference , @ % ; @ % CI , -@ % to @ % ) did not differ significantly .


Quality of the total mesorectal excision specimen in @ operated and analyzed surgeries was complete ( @ % ) and nearly complete ( @ % ) in @ % of the cases .


Negative circumferential radial margin was observed in @ % of the overall group ( @ % laparoscopic resection and @ % open resection ; P = @ ) .


Distal margin result was negative in more than @ % of patients irrespective of type of surgery ( P = @ ) .


Among patients with stage II or III rectal cancer , the use of laparoscopic resection compared with open resection failed to meet the criterion for noninferiority for pathologic outcomes .


Pending clinical oncologic outcomes , the findings do not support the use of laparoscopic resection in these patients .


To investigate the effect of intracervical and intravaginal application of seminal plasma on the endometrium , as assessed by endometrial/subendometrial vascularization and endometrial volume between the day of oocyte retrieval and the day of embryo transfer in an in-vitro fertilization/intracytoplasmic sperm injection ( IVF/ICSI ) cycle .


This was a double-blind , placebo-controlled , randomized study including patients undergoing a first or second IVF/ICSI cycle .


Homologous seminal plasma or placebo ( sodium chloride ) was injected into the cervix and posterior vaginal fornix just after follicle aspiration .


Three-dimensional power Doppler examination was performed @min before oocyte retrieval and @min before embryo transfer .


Main outcome measures were changes in vascularization flow index ( VFI ) , flow index ( FI ) and vascularization index ( VI ) of the endometrium/subendometrium using VOCAL ( Virtual Organ Computer-aided AnaLysis ) and endometrial volume .


One hundred patients agreed to participate in the study .


Twenty-three patients were excluded , mainly as a result of canceled embryo transfer .


Data were analyzed from @ patients receiving seminal plasma and @ receiving placebo .


No significant differences between the two groups were seen in VFI , FI or VI of the endometrium or subendometrium or in endometrial volume on the day of oocyte pick-up and on the day of embryo transfer .


Neither endometrial/subendometrial vascularization parameters nor endometrial volume seem to be affected by the application of seminal plasma in patients undergoing their first or second IVF/ICSI cycle .


To assess the efficacy and safety of lifitegrast ophthalmic solution @ % compared with placebo in subjects with dry eye disease .


Prospective , randomized , double-masked , placebo-controlled , parallel arm , multicenter clinical trial .


A total of @ adult subjects with dry eye disease .


Eligible subjects were randomized @:@ to receive topically administered lifitegrast ( @ % ) or placebo ( vehicle ) twice daily for @ days after a @-day open-label placebo run-in period .


After enrollment ( day @ ) , subjects were evaluated at days @ , @ , and @ .


Key objective ( fluorescein and lissamine staining scores -LSB- Ora scales -RSB- ) and subjective ( Ocular Surface Disease Index -LSB- OSDI -RSB- , @-item visual analog scale , and ocular discomfort score -LSB- Ora scale -RSB- ) measures were assessed at all visits .


The primary objective efficacy measure ( sign ) was mean change from baseline inferior corneal staining score ( ICSS ) at day @ .


The co-primary subjective efficacy measure ( symptom ) was the mean change from baseline in the visual-related function subscale score of the Ocular Surface Disease Index ( VR-OSDI ) .


Supportive measures included corneal fluorescein scores ( superior , central , total region ) and conjunctival lissamine scores ( nasal , temporal , total region ) and symptom scores at day @ .


The study met the primary objective efficacy ICSS end point in demonstrating superiority of lifitegrast compared with placebo ( P = @ ) .


Lifitegrast significantly reduced corneal fluorescein staining ( superior , P = @ ; total cornea , P = @ ) and conjunctival lissamine staining ( nasal , P = @ ; total conjunctiva , P = @ ) at day @ versus placebo .


Significant ( P < @ ) improvements in nasal and total lissamine scores were observed at day @ and maintained through day @ .


The study did not meet the co-primary subjective VR-OSDI measure ( P = @ ) .


However , significant improvements were observed at day @ in ocular discomfort ( P = @ ) and eye dryness ( P = @ ) , the most common and severe symptoms reported at baseline in both groups .


There were no unanticipated or serious ocular adverse events ( AEs ) .


The most frequent reported ocular AEs were transient intermittent instillation site symptoms ( irritation , discomfort ) primarily on the initial lifitegrast dose at day @ .


Lifitegrast ophthalmic solution @ % significantly reduced corneal fluorescein and conjunctival lissamine staining and improved symptoms of ocular discomfort and eye dryness compared with placebo when administered twice daily over @ days .


The objectives of this study were to assess whether @ g/d lupin protein , integrated into a mixed diet , might affect cardiovascular risk factors and whether l-arginine was responsible for these effects .


Seventy-two hypercholesterolemic subjects participated in the randomized , controlled , double-blind three-phase crossover study .


They were assigned to three diets with @ g/d lupin protein ( LP ) , milk protein ( MP ) or milk protein plus @ g/d arginine ( MPA ) each for @ d in a random order interrupted by @-week washout periods .


Lupin protein and the comparator milk protein were incorporated into complex food products ( bread , roll , sausage , and vegetarian spread ) .


Arginine was administered via capsules .


Sixty-eight subjects were included in final analyses .


Compared with MP , LDL cholesterol was significantly lower after LP .


Compared with MP and MPA , homocysteine was significantly lower after LP .


Compared with baseline , concentrations of total , LDL , and HDL cholesterol significantly decreased after LP and MPA .


Triacylglycerols and uric acid significantly decreased after LP .


The relative changes in total and LDL cholesterol were significantly greater for subjects with severe hypercholesterolemia ( > @ mmol/L ) than those with moderate hypercholesterolemia ( @-@ @ mmol/L ) .


The present study showed for the first time that incorporation of @ g/d of lupin protein into a variety of complex food products lowers total and LDL cholesterol , triacylglycerols , homocysteine , and uric acid in hypercholesterolemic subjects .


The hypocholesterolemic effect is stronger in subjects with severe hypercholesterolemia .


Arginine might be responsible for some , but not all of the beneficial effects of lupin protein .


This trial was registered at http://clinicaltrials.gov ( study ID number NCT@ ) .


Liquid preserved packed red blood cell ( LPRBC ) transfusions are used to treat anemia and increase end-organ perfusion .


Throughout their storage duration , LPRBCs undergo biochemical and structural changes collectively known as the storage lesion .


These changes adversely affect perfusion and oxygen off-loading .


Cryopreserved RBCs ( CPRBC ) can be stored for up to @ years and potentially minimize the associated storage lesion .


We hypothesized that CPRBCs maintain a superior biochemical profile compared with LPRBCs .


This was a prospective , randomized , double-blinded study .


Adult trauma patients with an Injury Severity Score ( ISS ) greater than @ and an anticipated @-U to @-U transfusion of PRBCs were eligible .


Enrolled patients were randomized to receive either CPRBCs or LPRBCs .


Serum proteins ( haptoglobin , serum amyloid P , and C-reactive protein ) , proinflammatory and anti-inflammatory cytokines , d-dimer , nitric oxide , and @,@-DPG concentrations were analyzed .


Mann-Whitney U-test and Wilcoxon rank sum test were used to assess significance ( p < @ ) .


Fifty-seven patients were enrolled ( CPRBC , n = @ ; LPRBC , n = @ ) .


The LPRBC group 's final interleukin @ , tumor necrosis factor , and d-dimer concentrations were elevated compared with their pretransfusion values ( p < @ ) .


After the second transfused units , @,@-DPG was higher in the patients receiving CPRBCs ( p < @ ) ; this difference persisted throughout the study .


Finally , serum protein concentrations were decreased in the transfused CPRBC units compared with LPRBC ( p < @ ) .


CPRBC transfusions have a superior biochemical profile : an absent inflammatory response , attenuated fibrinolytic state , and increased @,@-DPG .


A blood banking system using both storage techniques will offer the highest-quality products to critically injured patients virtually independent of periodic changes in donor availability and transfusion needs .


Therapeutic study , level II .


To compare the efficacy and cognitive side effects of high-dose unilateral brief pulse electroconvulsive therapy ( ECT ) with those of high-dose unilateral ultrabrief pulse ECT in the treatment of major depression .


From April @ until March @ , we conducted a prospective , double-blind , randomized multicenter trial in @ tertiary psychiatric hospitals .


All patients with a depressive disorder according to DSM-IV criteria were eligible .


Depression severity was assessed with the Montgomery-Asberg Depression Rating Scale ; primary efficacy outcomes were response , defined as a score decrease @ % from baseline , and remission , defined as a score < @ at @ consecutive weekly assessments .


Total scores on the Autobiographical Memory Interview and Amsterdam Media Questionnaire were the primary outcome measures for retrograde amnesia .


Other cognitive domains included category fluency ( semantic memory ) and letter fluency ( lexical memory ) .


Patients received twice-weekly unilateral brief pulse ( @ millisecond ) or ultrabrief pulse ( @-@ @ millisecond ) ECT @ times seizure threshold until remission , for a maximum of @ weeks .


Of the @ patients , @ % ( n = @ ) completed the study .


Among completers , @ % ( @/@ ) of those in the brief pulse group achieved remission versus @ % ( @/@ ) of those in the ultrabrief pulse group ( P = @ ) , and the brief pulse group needed fewer treatment sessions to achieve remission : mean ( SD ) of @ ( @ ) versus @ ( @ ) sessions ( P = @ ) .


No significant group differences were found in the evaluation of the cognitive assessments .


The efficacy and speed of remission seen with high-dose brief pulse right unilateral ECT twice weekly were superior to those seen with high-dose ultrabrief pulse right unilateral ECT , with equal cognitive side effects as defined by retrograde amnesia , semantic memory , and lexical memory .


The effects of ovarian function suppression ( OFS ) on survival and patient-reported outcomes were evaluated in a phase III trial in which premenopausal women were randomly assigned to tamoxifen with or without OFS .


Premenopausal women with axillary node-negative , hormone receptor-positive breast cancer tumors measuring @ cm were randomly assigned to tamoxifen alone versus tamoxifen plus OFS ; adjuvant chemotherapy was not permitted .


Primary end points were disease-free survival ( DFS ) and overall survival ( OS ) .


Secondary end points included toxicity and patient-reported outcomes .


Patient-reported outcome data included health-related quality of life , menopausal symptoms , and sexual function .


These were evaluated at baseline , @ months , @ months , and then annually for up to @ years after registration .


In all , @ premenopausal women were enrolled : @ on tamoxifen alone and @ on tamoxifen plus OFS .


With a median follow-up of @ years , there was no significant difference between arms for DFS ( @-year rate : @ % v @ % ; log-rank P = @ ) or OS ( @-year rate : @ % v @ % ; log-rank P = @ ) .


Grade @ or higher toxicity was more common in the tamoxifen plus OFS arm ( @ % v @ % ; P = @ ) .


Patients treated with tamoxifen plus OFS had more menopausal symptoms , lower sexual activity , and inferior health-related quality of life at @-year follow-up ( P < @ for all ) .


Differences diminished with further follow-up .


When added to tamoxifen , OFS results in more menopausal symptoms and sexual dysfunction , which contributes to inferior self-reported health-related quality of life .


Because of early closure , this study is underpowered for drawing conclusions about the impact on survival when adding OFS to tamoxifen .


The present study examined how gain - and loss-framed informational videos about oral health influence self-reported flossing behavior over a @-month period , as well as the roles of perceived susceptibility to oral health problems and approach/avoidance motivational orientation in moderating these effects .


An age and ethnically diverse sample of @ American adults were randomized to receive no health message , or either a gain-framed or loss-framed video presented on the Internet .


Self-reported flossing was assessed longitudinally at @ and @ months .


Among the entire sample , susceptibility interacted with frame to predict flossing .


Participants who watched a video where the frame ( gain/loss ) matched perceived susceptibility ( low/high ) had significantly greater likelihood of flossing at recommended levels at the @-month follow-up , compared with those who viewed a mismatched video or no video at all .


However , young adults ( @-@ ) showed stronger moderation by motivational orientation than by perceived susceptibility , in line with previous work largely conducted with young adult samples .


Brief informational interventions can influence long-term health behavior , particularly when the gain - or loss-frame of the information matches the recipient 's beliefs about their health outcome risks .


The aim of this study is to compare the efficacy and safety of expectant management with surgical management of first-trimester miscarriage .


This randomised prospective study was conducted in the Gynaecology Department at University of Saarland Hospital , Germany between February @ and April @ .


A total of @ women were recruited following diagnosis of the first-trimester incomplete or missed miscarriage and randomised into two groups : @ women were randomised to expectant management ( group I ) , and @ women to surgical management ( groupII ) .


All women were examined clinically and sonographically during the follow-up appointments at weekly intervals for up to @ weeks as appropriate .


The outcome measures were : efficacy , short-term complications and duration of vaginal bleeding and pain .


Of @ eligible women , @ were lost to follow-up , and the remaining @ women were analysed .


The baseline characteristics were similar in both groups .


The total success rate at @ weeks was lower for expectant than for surgical management ( @ vs @ % ; P = @ ) .


The type of miscarriage was a significant factor affecting the success rate .


For missed miscarriage , the success rates for expectant versus surgical management were @ and @ % , respectively .


For women with incomplete miscarriage , the rates were @ and @ % .


No differences were found in the number of emergency curettages between the two study groups .


The duration of bleeding was significantly more in the expectant than the surgical management ( mean @ vs @ days ; P < @ ) .


The duration of pain was also more in the expectant than the surgical group ( mean @ vs @ days ; P < @ ) .


The total complication rates were similar in both groups ( expectant @ % vs surgical group @ % ; P = @ ) .


However , the pelvic infection was significantly lower in the expectant than the surgical group ( @ vs @ % , respectively ; P = @ ) .


Expectant management of clinically stable women with first-trimester miscarriage is safe and effective and avoids the need for surgery and the subsequent risk of anaesthesia in about @ % of cases , and has lower pelvic infection rate than surgical curettage .


However , surgical management is more successful , and with a shorter duration of bleeding and pain .


Therefore , the patient 's preference should be considered in the counselling process .


To examine the effectiveness of dance on motor functions , cognitive functions , and mental symptoms of Parkinson 's disease ( PD ) .


This study employed a quasi-randomised , between-group design .


Dance , PD exercise , and all assessments were performed in community halls in different regions of Japan .


Forty-six mild-moderate PD patients participated .


Six PD patient associations that agreed to participate in the study were randomly assigned to a dance group , PD exercise group , or non-intervention group .


The dance and PD exercise groups performed one @-min session per week for @ weeks .


Control group patients continued with their normal lives .


All groups were assessed before and after the intervention .


We used the Timed Up-and-Go Test ( TUG ) and Berg Balance Scale ( BBS ) to assess motor function , the Frontal Assessment Battery at bedside ( FAB ) and Mental Rotation Task ( MRT ) to assess cognitive function , and the Apathy Scale ( AS ) and Self-rating Depression Scale ( SDS ) to assess mental symptoms of PD .


The Unified Parkinson 's Disease Rating Scale ( UPDRS ) was used for general assessment of PD .


When comparing results before and after intervention , the dance group showed a large effect in TUG time ( ES = @ , p = @ ) , TUG step number ( ES = @ , p = @ ) , BBS ( ES = @ , p = @ ) , FAB ( ES = @ , p = @ ) , MRT response time ( ES = @ , p < @ ) , AS ( ES = @ , p < @ ) , SDS ( ES = @ , p = @ ) and UPDRS ( ES = @ , p < @ ) .


Dance was effective in improving motor function , cognitive function , and mental symptoms in PD patients .


General symptoms in PD also improved .


Dance is an effective method for rehabilitation in PD patients .


Ischemic mitral regurgitation is associated with a substantial risk of death .


Practice guidelines recommend surgery for patients with a severe form of this condition but acknowledge that the supporting evidence for repair or replacement is limited .


We randomly assigned @ patients with severe ischemic mitral regurgitation to undergo either mitral-valve repair or chordal-sparing replacement in order to evaluate efficacy and safety .


The primary end point was the left ventricular end-systolic volume index ( LVESVI ) at @ months , as assessed with the use of a Wilcoxon rank-sum test in which deaths were categorized below the lowest LVESVI rank .


At @ months , the mean LVESVI among surviving patients was @ ml per square meter of body-surface area in the repair group and @ ml per square meter in the replacement group ( mean change from baseline , -@ and -@ ml per square meter , respectively ) .


The rate of death was @ % in the repair group and @ % in the replacement group ( hazard ratio with repair , @ ; @ % confidence interval , @ to @ ; P = @ by the log-rank test ) .


There was no significant between-group difference in LVESVI after adjustment for death ( z score , @ ; P = @ ) .


The rate of moderate or severe recurrence of mitral regurgitation at @ months was higher in the repair group than in the replacement group ( @ % vs. @ % , P < @ ) .


There were no significant between-group differences in the rate of a composite of major adverse cardiac or cerebrovascular events , in functional status , or in quality of life at @ months .


We observed no significant difference in left ventricular reverse remodeling or survival at @ months between patients who underwent mitral-valve repair and those who underwent mitral-valve replacement .


Replacement provided a more durable correction of mitral regurgitation , but there was no significant between-group difference in clinical outcomes .


( Funded by the National Institutes of Health and the Canadian Institutes of Health ; ClinicalTrials.gov number , NCT@ . )


Efficacy of available therapies for patients with HCV who have previously failed treatment is limited .


Two Phase III , open-label trials in Japan investigated efficacy and safety of simeprevir and peginterferon -- @a/ribavirin ( PR ) combination therapy in treatment-experienced patients with genotype @ HCV infection .


In CONCERTO-@ , prior non-responders to IFN-based therapy ( N = @ ) received simeprevir ( TMC@ ) @ mg QD with PR for @ ( SMV@ , n = @ ) or @ weeks ( SMV@ , n = @ ) followed by response-guided therapy ( RGT ) with PR for @/@ ( SMV@ ) or @/@ ( SMV@ ) weeks .


In CONCERTO-@ , relapsers after IFN-based therapy ( N = @ ) received simeprevir @ mg QD with PR for @ weeks followed by RGT with PR for @/@ weeks .


Primary endpoints were the rates of sustained virologic response @ weeks after treatment end ( SVR@ ) .


SVR@ rates were @ % ( SMV@ ) and @ % ( SMV@ ) for prior non-responders , and @ % for prior relapsers ( SMV@ ; p @ vs null hypothesis , respectively ) .


Most prior non-responders ( SMV@ : @ % ; SMV@ : @ % ) and prior relapsers ( @ % ) met RGT criteria and completed PR to Week @ .


Of these , @ % , @ % , and @ % , respectively , achieved SVR@ .


Viral breakthrough occurred in @ % ( SMV@ ) and @ % ( SMV@ ) of prior non-responders ; no viral breakthrough occurred in prior relapsers .


Viral relapse occurred in @ % ( SMV@ ) and @ % ( SMV@ ) of prior non-responders and @ % of prior relapsers .


Simeprevir with PR was generally well tolerated in both studies .


Re-treatment with @ weeks of simeprevir QD with PR provided high SVR in treatment-experienced patients with chronic HCV genotype @ infection , and allowed most patients to complete treatment in @ weeks .


To compare intraobserver repeatability and interobserver and intersession reproducibility of lower tear meniscus height measurements ( LTMH ) obtained with the new Keratograph @M and a Fourier-domain optical-coherence tomography ( OCT ; Spectralis OCT ) and to assess the agreement between the two devices .


This is a observational cross-sectional study .


Thirty eyes of @ normal subjects were randomly imaged twice with both devices in our setting .


Two examiners randomly made LTMH measurements using the devices .


To assess intraobserver repeatability and interobserver and intersession reproducibility within-subject SD ( Sw ) , test-retest repeatability , coefficient of variation ( CoV ) and intraclass correlation coefficients ( ICCs ) were calculated .


Agreement between both devices was also determined .


Average LMTH for Keratograph was @ m , whereas the mean LTMH measured by OCT was @ m. Intraobserver repeatability and interobserver and intersession reproducibility were moderate with Keratograph ( CoV @ % , @ % , @ % and ICC @ , @ , @ , respectively ) and high for the Spectralis OCT ( CoV @ % , @ % , @ % and ICC @ , @ , @ , respectively ) .


No statistically significant difference was detected in mean LMTH measurements made with both devices , although correlation was low ( CoV @ % , ICC @ ) .


Spectralis OCT LTMH measurements were more reliable than the new Keratograph data .


Agreement between the devices was poor .


The aim of the study was to compare the effect of mefenamic acid and ginger on pain management in primary dysmenorrhea .


One hundred and twenty-two female students with moderate to severe primary dysmenorrhea were randomly allocated to the ginger and mefenamic groups in a randomized clinical trial .


The mefenamic group received @ mg capsules every @ h , and the ginger group received @ mg capsules ( zintoma ) every @ h from the onset of menstruation until pain relief lasted @ cycles .


The intensity of pain was assessed by the visual analog scale .


Data were analyzed by descriptive statistics , t test , Chi-square , Fisher exact test and repeated measurement .


The pain intensity in the mefenamic and ginger group was @ @ and @ @ , respectively , in the first month , and @ @ and @ @ , respectively , in the second month ( p > @ ) .


The severity of dysmenorrhea , pain duration , cycle duration and bleeding volume was not significantly different between groups during the study .


The menstrual days were more in the ginger group in the first ( p = @ ) and second cycle ( p = @ ) .


Repeated measurement showed a significant difference in pain intensity within the groups by time , but not between groups .


Ginger is as effective as mefenamic acid on pain relief in primary dysmenorrhea .


Ginger does not have adverse effects and is an alternative treatment for primary dysmenorrhea .


This prospective , randomized trial compared ultrasound-guided targeted intracluster injection ( TII ) supraclavicular brachial plexus block ( SCB ) and infraclavicular brachial plexus block ( ICB ) .


Sixty-four patients were randomly allocated to receive an ultrasound-guided TII SCB ( n = @ ) or ICB ( n = @ ) .


The local anesthetic agent ( lidocaine @ % with epinephrine @ g/mL ) was identical in all subjects .


In the TII SCB group , half the volume ( @ mL ) was injected inside the largest neural cluster ( confluence of trunks and divisions of the brachial plexus ) .


Subsequently , the remaining half ( @ mL ) was divided into equal aliquots and injected inside every single satellite cluster .


In the ICB group , the entire volume ( @ mL ) was injected dorsal to the axillary artery .


During the performance of the block , the performance time , number of needle passes , procedural pain , and complications ( vascular puncture , paresthesia ) were recorded .


Subsequently , a blinded observer assessed the onset time , incidence of Horner syndrome , and success rate ( surgical anesthesia ) .


The main outcome variable was the total anesthesia-related time ( sum of performance and onset times ) .


Due to a quicker onset -LSB- @ ( @ ) vs @ ( @ ) minutes ; P < @ -RSB- , the total anesthesia-related time was shorter with TII SCB -LSB- @ ( @ ) vs @ ( @ ) minutes ; P < @ -RSB- .


However no differences were observed between the @ groups in terms of success rate ( @ % -@ % ) , block-related pain scores , and adverse events such as vascular puncture and paresthesia .


Expectedly , the ICB group required fewer needle passes ( @ vs @ ; P < @ ) as well as shorter needling -LSB- @ ( @ ) vs @ ( @ ) minutes ; P < @ -RSB- and performance -LSB- @ ( @ ) vs @ ( @ ) minutes ; P < @ -RSB- times .


Moreover , the ICB approach was associated with a decreased incidence of Horner syndrome ( @ % vs @ % ; P < @ ) .


Ultrasound-guided TII SCB and ICB provide comparable success rates .


Due to its quick onset , TII SCB results in a shorter total anesthesia-related time .


To evaluate the therapeutic effects of tamsulosin on recurrent urinary tract infections in women with dysfunctional voiding .


A total of @ women with recurrent urinary tract infections and dysfunctional voiding were included and randomly assigned to the following groups : uroflowmetry biofeedback ( group @ ) , @-adrenoceptor antagonists ( group @ ) , uroflowmetry biofeedback combined with @-adrenoceptor antagonists ( group @ ) and no treatment ( group @ ) .


Patients were evaluated by the American Urological Association Symptom Index at @ , @ and @ months .


Urodynamics was carried out in patients of groups @ , @ , and @ at @ , @ and @ months , whereas urodynamics was only carried out at @ months in group @ .


All patients were followed up for @ year with monthly urine cultures .


The incidence of storage and emptying symptoms decreased significantly at @ , @ and @ months .


Mean flow rate , flow time and voiding volume increased significantly ( with a better outcome in patients of group @ ) , whereas post-void residual urine decreased .


Mean opening detrusor pressure and detrusor pressure at maximum flow decreased significantly ( with a better outcome in patients of group @ ) .


Mean urethral closure pressure and maximum urethral closure pressure decreased significantly with a more significant decrease for patients in group @ .


The prevalence of urinary tract infection decreased significantly in all groups after treatment , and this decrease remained stable during the follow up .


In women with dysfunctional voiding and recurrent urinary tract infection , tamsulosin associated with uroflowmetry biofeedback might be an effective and safe treatment option for improving urinary symptoms and quality of life .


We conducted a prospective single-blind randomized study to assess whether a single @,@ IU dose of human recombinant erythropoietin ( HRE ) , given just @ days before cardiac surgery , could be effective in reducing perioperative allogeneic red blood cell transfusion ( aRBCt ) .


Six-hundred patients presenting with preoperative hemoglobin ( Hb ) level of not more than @ g/dL were randomly assigned to either HRE or control .


The primary endpoint was the incidence of perioperative aRBCt .


The secondary endpoints were mortality and the incidence of adverse events in the first @ days after surgery , Hb level on Postoperative Day @ , and number of units of RBC transfusions in the first @ days after surgery .


A total of @ % ( HRE ) versus @ % ( control ) required transfusion ( relative risk , @ ; p < @ ) .


After baseline Hb was controlled for , there was no difference in the incidence of aRBCt between HRE ( @ % ) and control ( @ % ) among the patients with baseline Hb of @ g/dL or more , which included the nonanemic fraction of the study population .


The mean ( range ) Hb level on Postoperative Day @ was @ ( @-@ @ ) g/dL ( HRE ) versus @ ( @-@ @ ) g/dL ( control ; p < @ ) .


The distribution of number of units transfused was shifted toward fewer units in HRE ( p < @ ) .


The all-cause mortality at @ days was @ % ( HRE ) versus @ % ( control ) .


The @-day adverse event rate was @ % ( HRE ) versus @ % ( control ; both p = NS ) .


In anemic patients ( Hb < @ g/dL ) , a single high dose of HRE administered @ days before cardiac surgery is effective in reducing the incidence of aRBCt without increasing adverse events .


Controversy surrounds the effectiveness of dietary guidelines for cardiovascular disease ( CVD ) prevention in healthy middle-aged and older men and women .


The objective was to compare effects on vascular and lipid CVD risk factors of following the United Kingdom dietary guidelines with a traditional British diet ( control ) .


With the use of a parallel-designed randomized controlled trial in @ healthy nonsmoking men and women ( aged @-@ y ) , we measured ambulatory blood pressure ( BP ) on @ occasions , vascular function , and CVD risk factors at baseline and during @ wk after random assignment to treatment .


The primary outcomes were differences between treatments in daytime ambulatory systolic BP , flow-mediated dilation , and total cholesterol/HDL cholesterol .


Secondary outcomes were differences between treatment in carotid-to-femoral pulse wave velocity , high-sensitivity C-reactive protein , and a measure of insulin sensitivity ( Revised Quantitative Insulin Sensitivity Check Index ) .


Data were available on @ participants , and adherence to the dietary advice was confirmed from dietary records and biomarkers of compliance .


In the dietary guidelines group ( n = @ ) compared with control ( n = @ ) , daytime systolic BP was @ mm Hg ( @ % CI : @ , @ mm Hg ; P < @ ) lower , the treatment effect on flow-mediated dilation -LSB- -@ % ( @ % CI : -@ % , @ % ) -RSB- was not significant , the total cholesterol : HDL cholesterol ratio was @ ( @ % CI : @ , @ ; P = @ ) lower , pulse wave velocity was @ m/s ( @ % CI : @ , @ m/s ; P = @ ) lower , high-sensitivity C-reactive protein was @ % ( @ % CI : @ % , @ % ; P = @ ) lower , the treatment effect on the Revised Quantitative Insulin Sensitivity Check Index -LSB- @ % ( @ % CI : -@ % , @ % ) -RSB- was not significant , and body weight was @ kg ( @ % CI : @ , @ kg ; P < @ ) lower .


Causal mediated effects analysis based on urinary sodium excretion indicated that sodium reduction explained @ mm Hg ( @ % CI : @ , @ mm Hg ) of the fall in blood pressure .


Selecting a diet consistent with current dietary guidelines lowers BP and lipids , which would be expected to reduce the risk of CVD by one-third in healthy middle-aged and older men and women .


This study is registered at www.isrctn.com as @ .


Preventing recurrence of depression forms an important challenge for current treatments .


Cognitive control impairments often remain present during remission of depression , putting remitted depressed patients at heightened risk for new depressive episodes by disrupting emotion regulation processes .


Importantly , research indicates that cognitive control training targeting working memory functioning shows potential in reducing maladaptive emotion regulation and depressive symptomatology in clinically depressed patients and at-risk student samples .


The current study aims to test the effectiveness of cognitive control training as a preventive intervention in a remitted depressed sample , exploring effects of cognitive control training on rumination and depressive symptomatology , along with indicators of adaptive emotion regulation and functioning .


We present a double blind randomized controlled design .


Remitted depressed adults will complete @ online sessions of a cognitive control training targeting working memory functioning or a low cognitive load training ( active control condition ) over a period of @days .


Effects of training on primary outcome measures of rumination and depressive symptomatology will be assessed pre-post training and at three months follow-up , along with secondary outcome measure adaptive emotion regulation .


Long-term effects of cognitive control training on broader indicators of functioning will be assessed at three months follow-up ( secondary outcome measures ) .


This study will provide information about the effectiveness of cognitive control training for remitted depressed adults in reducing vulnerability for depression .


Furthermore , this study will address key questions concerning the mechanisms underlying the effects of cognitive control training , will take into account the subjective experience of the patients ( including a self-report measure for cognitive functioning ) , and explore whether these effects extend to broad measures of functioning such as Quality of Life and disability .


Vitamin D levels are alarmingly low ( < @ nmol/L ) in @-@ % of North American children older than @ year .


An increased risk of viral upper respiratory tract infections ( URTI ) , asthma-related hospitalizations and use of anti-inflammatory medication have all been linked with low vitamin D. No study has determined whether wintertime vitamin D supplementation can reduce the risk of URTI and asthma exacerbations , two of the most common and costly illnesses of early childhood .


The objectives of this study are : @ ) to compare the effect of ` high dose ' ( @ IU/day ) vs. ` standard dose ' ( @ IU/day ) vitamin D supplementation in achieving reductions in laboratory confirmed URTI and asthma exacerbations during the winter in preschool-aged Canadian children ; and @ ) to assess the effect of ` high dose ' vitamin D supplementation on vitamin D serum levels and specific viruses that cause URTI .


This study is a pragmatic randomized controlled trial .


Over @ successive winters we will recruit @ healthy children @-@ years of age .


Participating physicians are part of a primary healthcare research network called TARGet Kids !


Children will be randomized to the ` standard dose ' or ` high dose ' oral supplemental vitamin D for a minimum of @ months ( @ children per group ) .


Parents will obtain a nasal swab from their child with each URTI , report the number of asthma exacerbations and complete symptom checklists .


Unscheduled physician visits for URTIs and asthma exacerbations will be recorded .


By May , a blood sample will be drawn to determine vitamin D serum levels .


The primary analysis will be a comparison of URTI rate between study groups using a Poisson regression model .


Secondary analyses will compare vitamin D serum levels , asthma exacerbations and the frequency of specific viral agents between groups .


Identifying whether vitamin D supplementation of preschoolers can reduce wintertime viral URTIs and asthma exacerbations and what dose is optimal may reduce population wide morbidity and associated health care and societal costs .


This information will assist in determining practice and health policy recommendations related to vitamin D supplementation in healthy Canadian preschoolers .


Macrophage recruitment through C-C motif chemokine receptor-@ ( CCR@ ) into adipose tissue is believed to play a role in the development of insulin resistance and type @ diabetes mellitus ( T@DM ) .


The objective of this Phase @ proof-of-concept study was to evaluate the safety , tolerability , pharmacokinetics and pharmacodynamics of JNJ-@ , an orally bioavailable CCR@ antagonist , in patients with T@DM .


This was a @-week , double-blind , placebo-controlled , randomized , multicenter study .


A total of @ patients were randomized to receive either @ - or @-mg of JNJ-@ twice daily , @-mg of pioglitazone once daily ( reference arm ) , or placebo .


The primary endpoint was change from baseline in @-h weighted mean glucose ( WMG ) ; secondary endpoints included change from baseline in fasting plasma glucose ( FPG ) , insulin resistance ( Homeostatic Model Assessment -LSB- HOMA-IR -RSB- ) , insulin secretion ( HOMA - % B ) and body weight .


Absorption of JNJ-@ into the systemic circulation occurred at a median tmax of @ h , and the mean t was approximately @ h for both doses ; plasma systemic exposures increased slightly more than dose-proportionally .


After @ weeks , reductions in @-h WMG and FPG were observed in all treatment groups compared with placebo and were significantly lower for @-mg JNJ-@ and pioglitazone .


HOMA-IR was lower for all treatment groups , but significantly lower only for pioglitazone .


Conversely , HOMA - % B was increased for all groups , but significantly increased only for @-mg JNJ-@ .


All groups , including placebo , had decreased body weight over time .


There were no clinically significant findings during routine safety assessments and the incidence of treatment-emergent adverse events was similar across all groups .


Administration of JNJ-@ resulted in modest improvement in glycaemic parameters compared with placebo , and was generally well tolerated in patients with T@DM .


Extracurricular programmes could provide a mechanism to increase the physical activity ( PA ) of primary-school-aged children .


The aim of this feasibility study was to examine whether the Action @:@ intervention , which is delivered by teaching assistants , holds promise as a means of increasing the PA of Year @ and @ children .


A cluster randomised feasibility trial was conducted in @ primary schools .


Ten schools received the Action @:@ intervention and @ schools were allocated to the control arm .