Fifty-one subjects received mavrilimumab ( @-@ mg ) or placebo subcutaneously every other week for @ weeks , followed by a @-week follow-up period .


The primary endpoint was the proportion of subjects achieving a Disease Activity Score using @ joints ( DAS@ ) - C-reactive protein ( CRP ) response ( decrease > @ from baseline ) .


Secondary endpoints included DAS@-CRP remission , Health Assessment Questionnaire Disability Index ( HAQ-DI ) and American College of Rheumatology ( ACR ) response .


By Week @ , more mavrilimumab - versus placebo-treated subjects achieved a DAS@-CRP response ( @ % vs. @ % , p = @ ) ; a significant response was seen in the @ mg and @ mg dose groups ( both @ % vs. @ % , p = @ ) .


The @ mg group also demonstrated statistically significant HAQ-DI and ACR@ responses at Week @ .


Results were generally consistent between Japanese and European populations .


Overall , adverse events ( AEs ) were mild to moderate in intensity with one serious AE of pneumonia , considered possibly treatment-related .


A rapid and clinically meaningful response was seen in subjects treated with GM-CSFR blockade with mavrilimumab , supporting further investigation of mavrilimumab for the treatment of RA in Japanese subjects .


We compared the antiinflammatory and cardioprotective effects of the two most common regimens of corticosteroid administration in pediatric cardiac surgical procedures : a single dose delivered either at anesthesia induction or by cardiopulmonary bypass ( CPB ) prime .


Forty-five children , aged between @ and @ months and undergoing ventricular septal or atrioventricular septal defect correction , were randomized in double-blind fashion into three groups .


The anesthesia induction group received @ mg/kg methylprednisolone intravenously after anesthesia induction , and the CPB-prime group received @ mg/kg methylprednisolone by CPB circuit .


The placebo group received saline solution .


Plasma concentrations of methylprednisolone , interleukin ( IL ) -@ , IL-@ and IL-@ , and troponin were measured at anesthesia induction before the study drug , @ minutes on CPB , after patients were weaned from CPB , and @ hours after cessation of CPB .


Equally high methylprednisolone concentrations were detected in both methylprednisolone groups , but the measured peak concentration occurred earlier in the induction group .


Significantly lower IL-@ concentrations were observed just after patients were weaned from and @ hours after CPB in the anesthesia induction group compared with the placebo ( p = @ , p = @ ) and prime groups ( p = @ , p = @ ) .


Significant reductions of troponin were detected in both methylprednisolone groups compared with placebo ( induction , p = @ ; prime , p = @ ) @ hours after patients were weaned from CPB .


Methylprednisolone administration at anesthesia induction was superior in terms of antiinflammatory action .


Methylprednisolone administration in CPB-prime only a few minutes before aortic cross-clamping and cardioplegia resulted in mean troponin reductions similar to those of administration at anesthesia induction .


Corticosteroids may have direct cardioprotective properties , as reported in experimental studies .


To determine whether the postoperative administration of tryptophan would be beneficial for elderly adults undergoing surgery who are at risk of developing postoperative delirium .


Randomized , double-blind , placebo-controlled trial .


Denver Veterans Affairs Medical Center .


Individuals aged @ and older undergoing major elective operations requiring a postoperative intensive care unit ( ICU ) admission ( n = @ ) .


L-tryptophan , @g orally three times a day or placebo was started after surgery and continued for up to @days postoperatively .


Delirium and its motor subtypes were measured using the Confusion Assessment Method-Intensive Care Unit ( CAM-ICU ) and the Richmond Agitation and Sedation Scale .


The primary outcome for between-group comparison was the incidence of excitatory ( mixed and hyperactive ) postoperative delirium .


The secondary outcomes for comparison were the incidence and duration of overall postoperative delirium .


The overall incidence of postoperative delirium was @ % ( @ % confidence interval = @-@ % ) ( n = @ ) .


Seventeen percent of participants in the tryptophan group and @ % in the placebo group had excitatory delirium ( P = @ ) , and the duration of excitatory delirium was @ days for tryptophan and @ days for placebo ( P = @ ) .


Forty percent of participants in the tryptophan group and @ % in the placebo group had overall delirium ( P = @ ) , and the duration of overall delirium was @ days for tryptophan and @ days for placebo ( P = @ ) .


Postoperative tryptophan supplementation in older adults undergoing major elective operations requiring postoperative ICU admission did not reduce the incidence or duration of postoperative excitatory delirium or overall delirium .


Optimizing vancomycin dosing may help eradicate bacteria while avoiding resistance .


The guidelines recommend loading doses ; however , there are no data to demonstrate that this may result in a more rapid achievement of therapeutic troughs .


To evaluate the percentage of troughs reaching therapeutic levels at @ , @ , and @ hours following an initial vancomycin dose of @ mg/kg compared with @ mg/kg .


This prospective , randomized study was performed in a community academic medical center .


Patients who were to receive vancomycin in the emergency department were randomized to an initial traditional dose of @ mg/kg or a @-mg/kg loading dose followed by @ mg/kg every @ hours for @ doses .


Patients weighing > @ kg or with creatinine clearances < @ mL/min were excluded .


In total , @ patients were enrolled ; @ hours after the initial dose of vancomycin , there was a significantly greater proportion of patients reaching target trough levels of @ mg/L among the patients who received a loading dose as compared with a traditional dose ( @ % vs @ % , P < @ ) .


This trend continued at @ hours but was not statistically significant .


At @ hours , there was no difference in the percentage of patients reaching target levels between the @ groups .


No statistically significant difference in nephrotoxicity or adverse events among the @ groups was demonstrated .


A loading dose of @ mg/kg of vancomycin achieved a higher percentage of therapeutic levels at @ hours when compared with the traditional dose of @ mg/kg , without increased nephrotoxicity or adverse events .


United States pediatric guidelines recommend that childhood obesity counseling be conducted in the primary care setting .


Primary care-based interventions can be effective in improving health behaviors , but also costly .


The purpose of this study was to evaluate the cost of a primary care-based obesity prevention intervention targeting children between the ages of two and six years who are at elevated risk for obesity , measured against usual care .


High Five for Kids was a cluster-randomized controlled clinical trial that aimed to modify children 's nutrition and TV viewing habits through a motivational interviewing intervention .


We assessed visit-related costs from a societal perspective , including provider-incurred direct medical costs , provider-incurred equipment costs , parent time costs and parent out-of-pocket costs , in @ dollars for the intervention ( n = @ ) and usual care ( n = @ ) groups .


We conducted a net cost analysis using both societal and health plan costing perspectives and conducted one-way sensitivity and uncertainty analyses on results .


The total costs for the intervention group and usual care groups in the first year of the intervention were $ @,@ ( @ % CI -LSB- $ @,@ , $ @,@ -RSB- ) and $ @,@ ( @ % CI -LSB- $ @,@ , $ @,@ -RSB- ) .


The mean costs for the intervention and usual care groups were $ @ ( @ % CI -LSB- $ @ , $ @ -RSB- ) and $ @ ( @ % CI -LSB- $ @ , $ @ -RSB- ) per child , respectively , for a incremental difference of $ @ ( @ % CI -LSB- $ @ , $ @ -RSB- ) per child .


Children in the intervention group attended a mean of @ of a possible @ in-person visits and received @ of a possible @ counseling phone calls .


Provider-incurred costs were the primary driver of cost estimates in sensitivity analyses .


High Five for Kids was a resource-intensive intervention .


Further studies are needed to assess the cost-effectiveness of the intervention relative to other pediatric obesity interventions .


To investigate the efficacy of letrozole for delaying bone maturation and increasing predicted adult height in boys with idiopathic central precocious puberty ( ICPP ) who have a bone age above @ years and a short stature , and its adverse effects .


Twenty ICPP boys with a bone age above @ years and a short stature were randomly divided into letrozole treatment ( n = @ ) and control groups ( n = @ ) .


The letrozole treatment group received oral letrozole -LSB- @ mg / ( m ( @ ) d ) , Qd -RSB- for @ months , while the control group received no treatment and was observed periodically .


Bone age , growth rate , height standard deviation ( SD ) score , predicted adult height SD score , sexual maturity , and levels of follicle-stimulating hormone ( FSH ) , luteinizing hormone ( LH ) , dehydroepiandrosterone , testosterone ( T ) , estradiol ( E@ ) , progesterone ( P ) , and androstenedione ( ASD ) were measured .


The letrozole-related adverse reactions were evaluated .


After @ months of treatment , both groups had a significantly increased bone age , but the letrozole group had a significantly slowed increase in bone age compared with the control group ( @ @ years vs @ @ years ; P < @ ) ; compared with the control group , the letrozole group had a significantly increased predicted adult height SD score ( -@ @ vs -@ @ ; P < @ ) and a significantly increased T level ( @ @ nmol/L vs @ @ nmol/L ; P < @ ) .


There was no significant difference in testicular volume between the two groups .


The treatment led to no significant changes in growth rate , Tanner stage , and levels of FSH , LH , P , E@ and ASD in the two groups , and there was no significant difference in these indices between the two groups .


No adverse reactions were observed during letrozole treatment .


Letrozole delays bone maturation and increases predicted adult height in ICPP boys with a bone age above @ years and a short stature , and it causes no obvious adverse reactions .


In percutaneous nephrolithotomy ( PCNL ) , placement of the access tract into the kidney is an important aspect of the procedure and is responsible for the steep learning curve associated with the operation .


The aim of the current prospective randomized trial was to assess the duration of radiation exposure along with the safety and efficacy of PCNL done by a trainee , utilizing either ultrasonography ( US ) or fluoroscopic guidance to obtain access .


Sixty-four patients with @cm renal calculi undergoing single-tract PCNL by trainee urologists ( experience of < @ PCNL 's ) were randomized into US - and fluoroscopic-guided access groups ( @ in each ) .


In Group @ ( US guided ) , puncture was done using a @ / @MHz US probe with a puncture attachment , whereas the triangulation technique with biplanar C-arm fluoroscopy was utilized in group @ ( fluoroscopic guided ) .


Patient demographics , stone parameters , intraoperative characteristics , fluoroscopy durations , and postoperative outcomes were analyzed .


Both groups were comparable as far as patient and stone characteristics were concerned .


The fluoroscopy exposure during the puncture phase ( T@ ) and overall ( T ) was significantly lower in the US group at @ vs @ , ( p < @ ) and @ vs @ , ( p = @ ) .


Six patients in group@ required fluoroscopic adjustment ( p = @ ) .


All other intra - and postoperative parameters were similar in both the groups .


Both ultrasound and fluoroscopic guidance for renal access are equally safe and feasible in the hands of a trainee urologist .


Total fluoroscopy duration and exposure time during puncture were both significantly less in the ultrasound group .


Expertise in fluoroscopic-guided access is essential for a novice to effectively achieve access in all possible situations .


Hangeshashinto ( TJ-@ , a Kampo medicine ) , which reduces the level of prostaglandin E@ and affects the cyclooxygenase activity , alleviates chemotherapy-induced oral mucositis ( COM ) .


We conducted a randomized comparative trial to investigate whether TJ-@ prevents and controls COM in patients with gastric cancer .


We randomly assigned patients with gastric cancer who developed moderate-to-severe oral mucositis ( CTCAE v@ @ grade @ ) during any cycle of chemotherapy to receive either TJ-@ or a placebo as a double-blind trial .


The patients received a placebo or TJ-@ for @-@ weeks according to the chemotherapy regimen from the beginning of the next course of chemotherapy .


The primary end point was the incidence of grade @ oral mucositis in the protocol treatment course , and the secondary end points were the time to disappearance of oral mucositis and the incidence of adverse events .


Following the key opening of the blinding protocol , we analyzed @ eligible patients ( TJ-@ : @ , placebo : @ ) using a `` per protocol set '' analysis .


The incidence of grade @ COM was @ % in the TJ-@ group and @ % in the placebo group ( p = @ ) .


The median duration of grade @ COM was @ days in the TJ-@ group and @ days in the placebo group ( p = @ ) .


Meanwhile , the median duration of any grade of COM was @ days in the TJ-@ group and @ days in the placebo group among the patients who developed grade @ symptoms during the screening cycle -LSB- hazard ratio @ ; @ % CI ( @-@ @ ) , p = @ -RSB- .


Although TJ-@ treatment did not reduce the incidence of @ COM in the patients who developed mucositis during chemotherapy for gastric cancer , a trend was observed in which TJ-@ reduced the risk of COM in the patients who developed grade @ COM during the screening cycle .


Further , phase III studies with a larger sample size are needed to clarify the protective effects of TJ-@ for COM .


Genetic information , typically communicated in-person by genetic counselors , can be challenging to comprehend ; delivery of this information online -- as is becoming more common -- has the potential of increasing these challenges .


To address the impact of the mode of delivery of genomic risk information , @ individuals were recruited from the general public and randomized to receive genomic risk information for type @ diabetes mellitus in-person from a board-certified genetic counselor or online through the testing company 's website .


Participants were asked to indicate their genomic risk and overall lifetime risk as reported on their test report as well as to interpret their genomic risk ( increased , decreased , or same as population ) .


For each question , @ % of participants correctly indicated their risk .


Participants who received their results in-person were more likely than those who reviewed their results on-line to correctly interpret their genomic risk ( @ vs. @ % , p = @ ) and report their actual genomic risk ( @ vs. @ % , p = @ ) .


The delivery of personal genomic risk through a trained health professional resulted in significantly higher comprehension .


Therefore , if the online delivery of genomic test results is to become more widespread , further evaluation of this method of communication may be needed to ensure the effective presentation of results to promote comprehension .


A high prevalence of hyperandrogenism has been reported in women with type @ diabetes ( T@D ) .


Metformin has been used as a therapeutic agent in patients with polycystic ovarian syndrome and in T@D patients without hyperandrogenism .


This study sought to determine the effect of metformin on hyperandrogenism and ovarian function in adolescents with T@D .


We recruited @ girls with T@D .


The participants had hyperandrogenism and displayed suboptimal metabolic control .


The patients were enrolled in a randomized , double-blind , placebo-controlled trial .


One group received metformin ( @ mg bid ) and the other group received a placebo .


Treatment was administered for @ months .


Ovulation , steroids and gonadotropin levels were evaluated .


Metformin treatment was associated with decreases in testosterone , free androgen index , androstenedione , @-OH progesterone and estradiol levels .


The girls who were treated with placebo showed stable steroid , gonadotropin and sex hormone-binding globulin levels during the analysis .


No differences were observed in the Ferriman-Gallwey scores , ovulation rates , HbA@c levels or daily insulin doses of the girls treated with metformin compared with the placebo group .


Treating hyperandrogenic T@D adolescents with metformin significantly decreased the serum androgens compared to the placebo , but metformin therapy did not significantly affect clinical parameters , such as hirsutism , ovulation and metabolic control .


To explore the dynamics of aggregation of platelets and erythrocytes , their deformity and computed morphodensitometric parameters in patients with chronic cerebral ischemia , stages I and II , treated with cerebrolysin .


We examined @ patients , including @ men and @ women , aged from @ to @ years .


Patients were randomized by disease stage and treatment ( standard treatment with or without cerebrolysin ) .


The dynamics of neurological and emotional status as well as cognitive functions and results of laboratory studies were assessed .


Along with the total positive effect of cerebrolysin on the clinical picture , additional mechanisms of its action ( antiaggregant , antihypoxic and membranotropic ) improved the erythrocyte morphodensitometric parameters , hemostatic , hemorheological and blood gas transport characteristics , in particular on the microcirculatory level .


The Secondary Prevention of Small Subcortical Stroke trial ( SPS@ ) recruited participants meeting clinical and radiological criteria for symptomatic lacunes .


Individuals randomized to dual antiplatelet therapy with clopidogrel and aspirin had an unanticipated increase in all-cause mortality compared with those assigned to aspirin .


We investigated the factors associated with mortality in this well-characterized population .


We identified independent predictors of mortality among baseline demographic and clinical factors by Cox regression analysis in participants of the SPS@ trial .


Separately , we examined the effect on mortality of nonfatal bleeding during the trial .


During a mean follow-up of @ years , the mortality rate was @ % per year for the @ participants ( mean age , @ years ) .


Significant independent predictors of mortality at study entry were age , diabetes mellitus , history of hypertension , systolic blood pressure ( hazard ratio -LSB- HR -RSB- , @ per @ mm Hg increase ) , serum hemoglobin < @ g/dL ( HR , @ ) , renal function ( HR , @ per estimated glomerular filtration rate decrease of @ mL/min ) , and body mass index ( HR , @ per @ kg/m@ decrease ) .


Participants with ischemic heart disease ( P = @ for interaction ) and normotensive/prehypertensive participants ( P = @ for interaction ) were at increased risk if assigned to dual antiplatelet therapy .


Nonfatal major hemorrhage increased mortality in both treatment arms ( HR , @ ; @ % confidence interval , @-@ @ ; P < @ ) .


Unexpected interactions between assigned antiplatelet therapy and each of ischemic heart disease and normal/prehypertensive status accounted for increased mortality among patients with recent lacunar stroke given dual antiplatelet therapy .


Despite extensive exploratory analyses , the mechanisms underlying these interactions are uncertain .


To investigate the efficacy and safety of the dipeptidyl peptidase-@ inhibitor linagliptin in patients with Type@ diabetes mellitus inadequately controlled by a combination of metformin and pioglitazone .


This was a multi-centre , phase@ , randomized , double-blind , placebo-controlled study comparing linagliptin @mg once daily ( n = @ ) and placebo ( n = @ ) as add-on to metformin and pioglitazone .


The primary endpoint was the change from baseline in glycated haemoglobin ( HbA@c ) after @weeks .


The placebo-corrected adjusted mean ( se ) change in HbA@c from baseline to @weeks was -@ ( @ ) mmol/mol -LSB- -@ ( @ ) % -RSB- ( P < @ ) .


In patients with baseline HbA@c @mmol/mol ( @ % ) , @ % of patients in the linagliptin group and @ % in the placebo group achieved HbA@c < @mmol/mol ( @ % ) ( odds ratio@ @ ; P = @ ) .


The placebo-corrected adjusted mean ( se ) change from baseline in fasting plasma glucose at week@ was -@ ( @ ) mmol/l -LSB- -@ ( @ ) mg/dl -RSB- ( P = @ ) .


The incidence of serious adverse events was @ % with linagliptin and @ % with placebo .


Investigator-defined hypoglycaemia occurred in @ % of the linagliptin group and @ % of the placebo group .


No meaningful changes in mean body weight were noted for either group .


Linagliptin as add-on therapy to metformin and pioglitazone produced significant and clinically meaningful improvements in glycaemic control , without an additional risk of hypoglycaemia or weight gain ( Clinical Trials Registry No : NCT @ ) .


The study aimed at comparing the effectiveness and maternal satisfaction of oral misoprostol with vaginal misoprostol for induction of labor at term .


A randomized controlled trial of @ term pregnant women at the University of Nigeria Teaching Hospital Enugu , Nigeria , was conducted from April @ to May @ .


The women were equally randomized into two groups ( A and B ) to receive oral and vaginal misoprostol , respectively .


The vaginal route reduced the mean induction-vaginal delivery interval by four-and-half hours ( @ @ vs. @ @ ; mean difference : @ , @ % CI @-@ @ ; p = @ ) .


Furthermore , the mean dose of misoprostol required to achieve induction of labor and the mean duration of oxytocin augmentation when indicated were significantly less in the vaginal group than in the oral group ( @ @ vs. @ @ ; mean difference : @ , @ % CI @-@ @ ; p = @ and @ @ vs. @ @ ; mean difference : @ , @ % CI @-@ @ ; p = @ respectively ) .


However , neonatal complications and maternal satisfaction were similar between the two groups .


Both routes of administration are effective in the induction of labor at term and have comparable maternal satisfaction .


However , the vaginal route has the added advantage of shorter induction-delivery interval among others , and thus should be highly considered when induction of labor is indicated at term .


The incidence of acute kidney injury ( AKI ) is increasing globally and it is much more common than end-stage kidney disease .


AKI is associated with high mortality and cost of hospitalisation .


Studies of treatments to reduce this high mortality have used differing renal replacement therapy ( RRT ) modalities and have not shown improvement in the short term .


The reported long-term outcomes of AKI are variable and the effect of differing RRT modalities upon them is not clear .


We used the prolonged follow-up of a large clinical trial to prospectively examine the long-term outcomes and effect of RRT dosing in patients with AKI .


We extended the follow-up of participants in the Randomised Evaluation of Normal vs. Augmented Levels of RRT ( RENAL ) study from @ days to @ years after randomization .


Primary and secondary outcomes were mortality and requirement for maintenance dialysis , respectively , assessed in @,@ ( @ % ) patients at a median of @ months ( interquartile range -LSB- IQR -RSB- @-@ @ months ) post randomization .


A total of @/@ ( @ % ) and @/@ ( @ % ) patients died in the lower and higher intensity groups , respectively ( risk ratio -LSB- RR -RSB- @ , @ % CI @-@ @ , p = @ ) .


Amongst survivors to day @ , @ of @ ( @ % ) and @ of @ ( @ % ) in the respective groups were treated with maintenance dialysis ( RR @ , @ % CI @-@ @ , p = @ ) .


The prevalence of albuminuria among survivors was @ % and @ % , respectively ( p = @ ) .


Quality of life was not different between the two treatment groups .


The generalizability of these findings to other populations with AKI requires further exploration .


Patients with AKI requiring RRT in intensive care have high long-term mortality but few require maintenance dialysis .


Long-term survivors have a heavy burden of proteinuria .


Increased intensity of RRT does not reduce mortality or subsequent treatment with dialysis .


The incidence of non-alcoholic fatty liver disease ( NAFLD ) is increasing dramatically affecting up to @ % of the population worldwide .


At present , treatment options are limited and pharmacological management of NAFLD has had disappointing results .


Some of the best available evidence to improve NAFLD concerns lifestyle modification .


To detect the degree of weight reduction needed to improve the markers of hepatic function and insulin resistance in type-@ diabetics with NAFLD .


One hundred type-@ diabetic male patients with NAFLD were included into this study and divided into two equal groups .


Group ( A ) received aerobic exercise training in addition to diet regimen .


Group ( B ) received no treatment intervention .


There was a @ % , @ % , @ % , @ % , @ % and @ % reduction in mean values of Alkaline Phosphatase ( ALP ) , Alanine Aminotransferase ( ALT ) , Aspartate Aminotransferase ( AST ) , Gamma - Glutamyltransferase ( GGT ) and Homeostasis Model Assessment-Insulin Resistance-index ( HOMA-IR ) and BMI respectively in group ( A ) at the end of the study .


While there were significant differences between mean levels of the investigated parameters in group ( A ) and group ( B ) after treatment .


About @ % reduction in BMI is effective to improve the liver condition and insulin resistance in type-@ diabetics with NAFLD .


Major depressive disorder ( MDD ) is a prevalent and severe disorder .


Although effective treatments for MDD are available , many patients remain untreated , mainly because of insufficient treatment capacities in the health care system .


Resulting waiting periods are often associated with prolonged suffering and impairment as well as a higher risk of chronification .


Web-based interventions may help to alleviate these problems .


Numerous studies provided evidence for the efficacy of web-based interventions for depression .


The aim of this study is to evaluate a new web-based guided self-help intervention ( GET.ON-Mood Enhancer-WL ) specifically developed for patients waiting to commence inpatient therapy for MDD .


In a two-armed randomised controlled trial ( n = @ ) , the web-based guided intervention GET.ON-Mood Enhancer-WL in addition to treatment as usual ( TAU ) will be compared with TAU alone .


The intervention contains six modules ( psycho education , behavioural activation I & II , problem solving I & II , and preparation for subsequent inpatient depression therapy ) .


The participants will be supported by an e-coach , who will provide written feedback after each module .


Inclusion criteria include a diagnosis of MDD assessed with a structured clinical interview -LSB- SCID -RSB- and a waiting period of at least three weeks before start of inpatient treatment .


The primary outcome is observer-rated depressive symptom severity ( HRSD@ ) .


Further ( explorative ) questions include whether remission will be achieved earlier and by more patients during inpatient therapy because of the web-based preparatory intervention .


If GET.ON-Mood Enhancer-WL is proven to be effective , patients may start inpatient therapy with reduced depressive symptom severity , ideally leading to higher remission rates , shortened inpatient therapy , reduced costs , and decreased waiting times .


Development of obesity after heart transplantation ( HT ) is a common complication , largely attributed to immunosuppressive therapy .


The objective of this study is to compare the incidence of development of obesity after HT , according to the calcineurin inhibitor ( CNI ) used ( cyclosporine -LSB- CsA -RSB- vs tacrolimus -LSB- Tac -RSB- ) .


We studied @ consecutive HT patients from November @ to December @ .


A diagnosis of overweight-obesity was made by a body mass index of @ kg/m ( @ ) , which was assessed before HT and at @ year after HT .


Patients were randomly assigned to the administration of CsA or Tac by a simple randomization method using a computer program ( @ % received CsA and @ % Tac ) .


Of the @ patients , @ % were men , and ischemic heart disease was the most common indication for HT .


At baseline , there were no differences in weight between groups treated with CsA or Tac .


The mean weight for each group was @ @ and @ @ kg , respectively ( P = @ ) .


The weight increase was greater among CsA patients : after HT , the weight gain was @ @ kg in the CsA group , whereas a minimal weight loss of @ @ kg ( P = @ ) was experienced in the group treated with Tac .


The multivariate analysis showed that only CsA treatment was an independent predictor of development of obesity @ year after HT ( odds ratio , @ ; @ % CI , @-@ @ ; P = @ ) .


Weight gain after HT may be related to the CNI used and CsA seems to be the CNI that produces the greatest increase .


To examine whether greater exposure to resin-based composite materials , which may intra-orally release bisphenol A ( BPA ) , is associated with worse renal function outcomes in children .


Prospective multi-centre study .


Community health dental clinics in Boston and Maine from @-@ .


Subjects and methods Five hundred and thirty-four New England Children 's Amalgam Trial participants aged six to ten years were randomised to treatment with amalgam or resin-based composite restorations over five years of follow-up .


Restorations were placed according to treatment arm , and sealants placed per standard of care .


Cumulative composite exposure was calculated using surface-years ( each treated surface weighted by number years present ) .


Urinary excretion of albumin , gamma-glutamyl transpeptidase ( gamma-GT ) , and N-acetyl -- D-glucosaminidase ( NAG ) were available for @ children .


Analysis of covariance showed no association between exposure to dental composites , polyacid-modified compomer , or flowable composite dental sealants and preventative resin restorations with levels of renal function .


There was no association between composite materials and thresholds indicating renal damage in logistic regression models .


This study found no harmful associations between dental composite materials and renal function in children .


Therefore , concerns about renal function need not be a consideration in the choice of dental restoration material or placement of preventative dental sealants .


The Organ Care System is the only clinical platform for ex-vivo perfusion of human donor hearts .


The system preserves the donor heart in a warm beating state during transport from the donor hospital to the recipient hospital .


We aimed to assess the clinical outcomes of the Organ Care System compared with standard cold storage of human donor hearts for transplantation .


We did this prospective , open-label , multicentre , randomised non-inferiority trial at ten heart-transplant centres in the USA and Europe .


Eligible heart-transplant candidates ( aged > @ years ) were randomly assigned ( @:@ ) to receive donor hearts preserved with either the Organ Care System or standard cold storage .


Participants , investigators , and medical staff were not masked to group assignment .


The primary endpoint was @ day patient and graft survival , with a @ % non-inferiority margin .


We did analyses in the intention-to-treat , as-treated , and per-protocol populations .


This trial is registered with ClinicalTrials.gov , number NCT@ .


Between June @ , @ , and Sept @ , @ , we randomly assigned @ patients to the Organ Care System group ( n = @ ) or the standard cold storage group ( n = @ ) .


@ day patient and graft survival rates were @ % ( n = @ ) in the Organ Care System group and @ % ( n = @ ) in the standard cold storage group ( difference @ % , one-sided @ % upper confidence bound @ ; p = @ ) .


Eight ( @ % ) patients in the Organ Care System group and nine ( @ % ) patients in the standard cold storage group had cardiac-related serious adverse events .


Heart transplantation using donor hearts adequately preserved with the Organ Care System or with standard cold storage yield similar short-term clinical outcomes .


The metabolic assessment capability of the Organ Care System needs further study .


Interactions between calcium and vitamin D may have implications for the regulation of serum @-hydroxyvitamin D -LSB- @ ( OH ) D -RSB- and its catabolism and , consequently , the vitamin D dietary requirement .


We investigated whether different calcium intakes influenced serum @ ( OH ) D and indexes of vitamin D activation and catabolism during winter and in the context of both adequate and inadequate vitamin D intakes .


A @-wk winter-based , randomized , placebo-controlled , double-blind vitamin D intervention ( @ g/d ) study was carried out in free-living men and women aged @ y ( n = @ ) who were stratified according to calcium intakes -LSB- moderate-low ( < @ mg/d ) or high ( > @ mg/d ) intake -RSB- .


The serum @ ( OH ) D concentration was the primary outcome , and serum calcium , parathyroid hormone ( PTH ) , @,@-dihydroxyvitamin D -LSB- @,@ ( OH ) D -RSB- , @,@-dihydroxyvitamin D -LSB- @,@ ( OH ) D -RSB- , the ratio of @,@ ( OH ) D to @ ( OH ) D , vitamin D-binding protein , and free @ ( OH ) D were exploratory outcomes .


A repeated-measures ANOVA showed there was no significant ( P = @ ) time vitamin D treatment calcium intake grouping interaction effect on the mean serum @ ( OH ) D concentration over the @-wk intervention period .


Serum @ ( OH ) D concentrations increased ( P @ ) and decreased ( P @ ) in vitamin D and placebo groups , respectively , and were of similar magnitudes in subjects with calcium intakes < @ mg/d ( and even < @ mg/d ) compared with > @ mg/d .


The response of serum PTH , @,@ ( OH ) D , @,@ ( OH ) D , the ratio of @,@ ( OH ) D to @ ( OH ) D , and free @ ( OH ) D significantly differed in vitamin D and placebo groups but not by calcium intake grouping .


We found no evidence of a vitamin D sparing effect of high calcium intake , which has been referred to by some authors as `` vitamin D economy . ''


Thus , recent dietary vitamin D requirement estimates will cover the vitamin D needs of even those individuals who have inadequate calcium intakes .


A recent Cochrane Review showed that early robotic training of the upper limb in stroke survivors can be more effective than other interventions when improving activities of daily living involving the arm function is the aim of therapy .


We tested for efficacy of the study a protocol which involved the use of the NeReBot therapy in partial substitution of standard upper limb rehabilitation in post-acute stroke patients .


In this dose-matched , randomized controlled clinical trial , @ hemiparetic participants with movement against gravity in shoulder , elbow , and wrist muscle groups were enrolled within @ days of the onset of stroke .


All participants received a total daily rehabilitation treatment for @ minutes , @ days per week for @ weeks .


The control group received standard therapy for the upper limb .


The experimental group received standard therapy ( @ % of exercise time ) associated with robotic training ( @ % of exercise time ) .


Muscle tone ( Modified Ashworth Scale ) , strength ( Medical Research Council ) , and synergism ( Fugl-Meyer motor scores ) were measured at impairment level , whereas dexterity ( Box and Block Test and Frenchay Arm Test ) and activities of daily living ( Functional Independence Measure ) were measured at activity level .


All assessments were performed at baseline , at the end of therapy ( time T@ ) , at @ months ( time T@ ) , and at @ months ( time T@ ) after entry .


All between-group analyses were tested using nonparametric test with Bonferroni 's adjustments for multiple testing .


No significant between-group differences were found with respect to demographic characteristics , motor , dexterity , and ADLs at baseline , postintervention ( T@ ) and at follow-up ( T@ and T@ ) .


The robot therapy by NeReBot did not lead to better outcomes compared with conventional inpatient rehabilitation .


Preventing smoking initiation among adolescents is crucial to reducing tobacco-caused death and disease .


This study focuses on the effectiveness of a Web-based computer-tailored smoking prevention intervention aimed at adolescents .


The intent of the study was to describe the intervention characteristics and to show the effectiveness and results of a randomized controlled trial .


We hypothesized that the intervention would prevent smoking initiation among Dutch secondary school students aged @-@ years and would have the largest smoking prevention effect among the age cohort of @-@ years , as smoking uptake in that period is highest .


The intervention consisted of a questionnaire and fully automated computer-tailored feedback on intention to start smoking and motivational determinants .


A total of @ secondary schools were recruited via postal mail and randomized into either the computer-tailored intervention condition or the control condition .


Participants had to complete a Web-based questionnaire at baseline and at @-month follow-up .


Data on smoking initiation were collected from @ students from these schools .


To identify intervention effects , multilevel logistic regression analyses were conducted using multiple imputation .


Smoking initiation among students aged @-@ years was borderline significantly lower in the experimental condition as compared to the control condition @ months after baseline ( OR @ , @ % CI @-@ @ , P = @ ) .


Additional analyses of the data for the @-@ year age group showed a significant effect , with @ % ( @/@ ) of the students in the control condition reporting initiation compared to @ % ( @/@ ) in the experimental condition ( OR @ , @ % CI @-@ @ , P = @ ) .


No moderation effects were found regarding gender and educational level .


The findings of this study suggest that computer-tailored smoking prevention programs are a promising way of preventing smoking initiation among adolescents for at least @ months , in particular among the age cohort of @-@ years .


Further research is needed to focus on long-term effects .


Endoscopic biliary sphincterotomy and stone removal is the standard of care for choledocholithiasis , with a success rate of > @ % .


For stones @ mm diameter , mechanical lithotripsy , extracorporeal shock wave lithotripsy , electrohydraulic lithotripsy , and laser lithotripsy can be used .


In the case of failure , the next step is surgery .


In elderly patients and in patients with an elevated surgical risk , stenting is the only treatment modality .


In these cases the aim is to avoid the onset of acute obstructive cholangitis .


The aim of the current study was to evaluate the best management of plastic stents in patients with biliary duct stones who were unfit for surgery and in whom previous endoscopic therapy had failed .


Patients who were high surgical risks and in whom stone clearance was not possible due to the number and sizes of stones were included .


Between March @ and September @ all patients were treated with endoscopic plastic biliary stenting at four tertiary care referral centers in Italy .


Patients were randomly assigned to two groups : in Group A ( n = @ ) plastic stents were changed every @ months or sooner if symptoms appeared ; in Group B plastic stents were changed on demand at the onset of symptoms , and ultrasonography and blood samples were performed every @ months to check for signs of cholestasis and inflammation .


The primary outcome was the rate of cholangitis .


The secondary outcome was the rate of stone clearance after a period of stenting .


A total of @ patients were included in the study ( @M/@F ; mean age @ years ) .


Acute cholangitis occurred in @ patients from Group A and in @ patients from Group B ( P = @ ) .


Mortality related to cholangitis occurred in one patient from Group A and three patients from Group B ( P = n.s. ) .


The mean follow-up was @ months ( range @-@ ) .


Stone clearance after long term stenting occurred in @ patients from Group A ( @ % ) and in @ patients from group B ( @ % ) ( P = n.s. ) .


In patients with bile duct stones who were treated with biliary plastic stents , the best stent management to avoid cholangitis was stent changing at defined intervals ( every @ months in the current study ) .


The data confirmed that plastic biliary stenting may decrease stone size with a high percentage of subsequent total stone clearance .


Previous analyses from a randomized trial in women aged @-@ have shown the quadrivalent HPV vaccine to be efficacious in the prevention of infection , cervical intraepithelial neoplasia ( CIN ) and external genital lesions ( EGL ) related to HPV @/@/@ / @ through @ years .


In this report we present long term follow-up data on the efficacy , safety and immunogenicity of the quadrivalent HPV vaccine in adult women .


Follow-up data are from a study being conducted in @ sites in Colombia designed to evaluate the long-term immunogenicity , effectiveness , and safety of the qHPV vaccine in women who were vaccinated at @ to @ years of age ( in the original vaccine group during the base study -LSB- n = @ -RSB- ) or @ to @ years of age ( in the original placebo group during the base study -LSB- n = @ -RSB- ) .


This analysis summarizes data collected as of the year @ post-vaccination visit relative to day @ of the base study ( median follow-up of @ years ) from both the original base study and the Colombian follow-up .


There were no cases of HPV @/@/@ / @-related CIN or EGL during the extended follow-up phase in the per-protocol population .


Immunogenicity persists against vaccine-related HPV types , and no evidence of HPV type replacement has been observed .


No new serious adverse experiences have been reported .


Vaccination with qHPV vaccine provides generally safe and effective protection from HPV @ - , @ - , @ - , and @-related genital warts and cervical dysplasia through @ years following administration to @-@ year-old women .


To evaluate whether trabectedin as first-line chemotherapy for advanced/metastatic soft tissue sarcoma prolongs progression-free survival ( PFS ) , compared to doxorubicin and , in the phase IIb part here , to select the most appropriate trabectedin treatment schedule ( @-hour or @-hour infusion ) in terms of safety , convenience and efficacy .


In this randomised multicentre prospective dose-selection phase IIb superiority trial , @ patients were randomised between doxorubicin ( n = @ ) , trabectedin ( @-hour infusion , T@h ) ( n = @ ) and trabectedin ( @-hour infusion , T@h ) ( n = @ ) .


PFS was defined as time from random assignment until objective progression by response evaluation criteria in solid tumours ( RECIST @ ) , a global deterioration of the health status requiring discontinuation of the treatment , or death from any cause .


The study was terminated due to lack of superiority in both trabectedin treatment arms as compared to the doxorubicin control arm .


Median PFS was @ months in the T@h arm , @ months in the T@h arm and @ months in the doxorubicin arm .


No significant improvements in PFS were observed in the trabectedin arms as compared to the doxorubicin arm ( T@h versus doxorubicin : hazard ratio ( HR ) @ , @ % confidence interval ( CI ) @-@ @ , P = @ ; T@h versus doxorubicin : HR @ , @ % CI @-@ @ , P = @ ) .


Only one toxic death occurred in the T@h arm , but treatment had to be stopped due to toxicity in @ ( @ % ) ( T@h ) , @ ( @ % ) ( T@h ) and @ ( @ % ) doxorubicin patients .


Doxorubicin continues to be the standard treatment in eligible patients with advanced/metastatic soft-tissue sarcoma ( STS ) .


Trabectedin @ mg/m ( @ ) / @-hour infusion is the overall proven approach to delivering this agent in the second-line setting for patients with advanced or metastatic STS .


Esophageal cancer is among the most common gastrointestinal cancers for which the main treatment is surgery .


This study was undertaken to analyze the results of Botox injection in preventing gastric stasis in these patients .


@ patients with esophageal cancer in the middle and lower third parts were included in our study between @ and @ , and were randomly divided into two groups .


In group A , @ patients underwent pyloroplasty , and in group B , injection of botulinum toxin into the pyloric sphincter muscle was used in @ patients .


The mean age of these patients was @ years and the male/female ratio was @:@ .


Isotope scans @ weeks after surgery showed that @ patients in group A and @ in group B had delayed gastric emptying ; there was no significant difference between the @ groups , and the success rate of Botox injection was @ % .


Considering the fact that there was no significant difference between pyloroplasty and Botox injection on gastric emptying after surgery , and given the need to use less-aggressive techniques and facilitate greater use of endoscopic methods , botulinum toxin injection may be used instead of pyloroplasty as a simple , effective , and complication-free method to prevent delayed gastric emptying .


Social support is associated with enhanced illness management and recovery in persons with mental illness , making it an important topic addressed through acute inpatient psychoeducational programs .


In addition , trust in the therapist may mediate clinical outcomes in this patient population .


To date , few studies have examined the effect of music-based psychoeducational programs on these variables .


The purpose of this study was to isolate and examine the component parts of a live educational music therapy intervention , and its effect on acute psychiatric inpatients ' perceived social support from significant others , family , and friends and trust in the therapist .


This study also explored whether trust in therapist varied across conditions , but did not examine it as a mediator for social support .


Participants ( N = @ ) were cluster-randomized in a single-session posttest-only design to one of four conditions : live educational music therapy , recorded educational music therapy , education without music , or recreational music therapy without education .


Conditions were designed to isolate the following intervention components : live vs. recorded music , educational vs. non-educational content , and music vs. nonmusic modality .


Dependent measures were assessed post intervention via established self-report instruments evaluating perceived social support and trust in the therapist .


There were no significant between-group differences for social support or trust in therapist total scores .


However , subscale score analyses revealed two significant between-group differences : ( a ) participants in the Live Educational Music Therapy condition reported significantly higher perceived therapist competence compared with the Recorded Educational Music Therapy condition ; ( b ) participants in the Live Educational Music Therapy condition reported significantly higher perceived support from friends compared with the Recreational Music Therapy condition .


Live educational music therapy may be a way to heighten psychiatric inpatients ' perceived social support concerning friends and perceptions of the therapist 's competence .


The current results demonstrated differences between live and recorded music therapy in psychiatric music therapy and provide empirical support for competent musicianship .


Implications for clinical practice , limitations , and suggestions for future research are included .


Hyperventilation has been associated with adverse effects on lung function , symptoms , and well-being in asthma .


We examined whether raising end-tidal CO@ levels ( ie , Pco@ ) compared with slow breathing is associated with improvements in asthma control , including peak flow variability .


One hundred twenty patients with asthma were randomly assigned to capnometry-assisted respiratory training ( CART ) for raising Pco@ or slow breathing and awareness training ( SLOW ) for slowing respiratory rate .


Patients received five weekly sessions and completed bid homework exercises over @ weeks .


Blinded assessments at baseline , posttreatment , @ - and @-month follow-up of asthma control , Pco@ , and diurnal peak flow variability were primary outcome measures .


Additionally , we measured pulmonary function ( spirometry , forced oscillation , exhaled nitric oxide , and methacholine challenge ) , symptoms , quality of life , and bronchodilator use .


Because the control group received active treatment , we expected improvements in asthma control in both groups but more pronounced benefits from CART .


Improvements were seen in @ of @ clinical indexes ( @ % ) in both interventions , including the primary outcome variables asthma control ( d = @ ) , peak flow variability ( d = @ ) , quality of life , bronchodilator use , lung function , and airway hyperreactivity .


Most improvements were sustained across the @-month follow-up .


Compared with slow breathing , CART showed greater increases in Pco@ ( d = @ vs @ for CART vs SLOW , respectively ) and greater reductions in respiratory impedance during treatment , less distress during methacholine challenge , and greater reduction in asthma symptoms at follow-up ( P < @ ) .


Brief interventions aimed at raising Pco@ or slowing respiratory rate provide significant , sustained , and clinically meaningful improvements in asthma control .


Raising Pco@ was associated with greater benefits in aspects of lung function and long-term symptoms .


Selective serotonin reuptake inhibitors ( SSRIs ) are common treatments for patients with major depressive disorder ( MDD ) .


However , adverse effects of SSRIs on sexual function are common in the treatment of patients with MDD .


There is a discrepancy in the reported frequency of SSRI-induced sexual dysfunction .


On the other hand , there is also less evidence about sexual dysfunction with serotonin receptor antagonists and reuptake inhibitors ( SARIs ) .


Therefore , we aimed to assess sexual dysfunction in MDD patients who received fluoxetine , sertraline and trazodone .


In a single-blind , randomized , controlled trial in Kermanshah , Iran , during @-@ , @ patients who met the DSMIV-IR criteria for MDD were enrolled .


The patients completed the Hamilton Depression Rating Scale ( HAM-D ) and the sexual function questionnaire ( SFQ ) .


Eligible patients were allocated in three treatment groups ( receiving fluoxetine , sertraline or trazodone ) for @ weeks randomly .


Measurement of HAMD was repeated in @-week interval .


Analysis for comparing sexual dysfunction among three groups and men and women was performed .


There were @ men and @ women in the three groups receiving fluoxetine ( n = @ ) , sertraline ( n = @ ) and trazodone ( n = @ ) .


There was no significant difference in the sexual dysfunction of the patients in the three groups at baseline ( P > @ ) .


After treatment , both men and women who had received fluoxetine had the most impairment in desire/drive items ( @ % -@ % and @ % -@ % , respectively ) , while patients receiving trazodone had the least impairment in these items ( @ % -@ % and @ % -@ % , respectively ) .


Trazodone was also induced with a lower rate of impairment in arousal/orgasm items in men ( @ % -@ % ) compared with the other two drugs .


Compared with fluoxetine and trazodone , sertraline was associated with intermediate impairment in sexual function ( @ % -@ % in desire/drive items and @ % -@ % in arousal/orgasm items ) that was lower than that with fluoxetine and more than that with trazodone .


There were different rates of sexual dysfunction with different antidepressants drugs in under treated patients .


Compared with fluoxetine , and sertraline , trazodone was associated with the fewest sexual dysfunction .


Fluoxetine was also associated with more sexual dysfunction than sertraline .


Further research to better identify the differences among antidepressant drugs is recommended .


To evaluate the potential efficacy of buspirone as a relapse-prevention treatment for cocaine dependence .


A randomized , double-blind , placebo-controlled , @-week pilot trial was conducted at @ clinical sites between August @ and June @ .


Adult crack cocaine users meeting DSM-IV-TR criteria for current cocaine dependence who were scheduled to be in inpatient/residential substance use disorder ( SUD ) treatment for @-@ days when randomized and planning to enroll in local outpatient treatment through the end of the active treatment phase were randomized to buspirone titrated to @ mg/d ( n = @ ) or placebo ( n = @ ) .


All participants received psychosocial treatment as usually provided by the SUD treatment programs in which they were enrolled .


Outcome measures included maximum days of continuous cocaine abstinence ( primary ) , proportion of cocaine use days , and days to first cocaine use during the outpatient treatment phase ( study weeks @-@ ) as assessed by self-report and urine drug screens .


There were no significant treatment effects on maximum continuous days of cocaine abstinence or days to first cocaine use .


In the female participants ( n = @ ) , there was a significant treatment-by-time interaction effect ( = @ , P < @ ) , reflecting an increase in cocaine use by those receiving buspirone , relative to placebo , early in the outpatient treatment phase .


A similar effect was not detected in the male participants ( n = @ ; = @ , P = @ ) .


The results suggest that buspirone is unlikely to have a beneficial effect on preventing relapse to cocaine use and that buspirone for cocaine-dependent women may worsen their cocaine use outcomes .


People with intellectual disabilities ( ID ) have lower levels of physical activity and quality of life and they have a lot of barriers to face when taking part in physical activity .


Other problems are the poor adherence to physical activity such people have so this study is designed to improve adherence to physical activity for people with intellectual disabilities with the assistance of an application for smartphones .


The aim of the study will be to improve physical activity and physical condition after multimodal intervention and to analyse the promotion of adherence to physical activity through a multimodal intervention and an app intervention ( mHealth ) in people with ID .


A two-stage study will be conducted .


In stage @ a multimodal intervention will take place will be done with physical activity and educational advice over eight weeks , two days a week .


Data will be measured after and before the intervention .


In stage @ a randomized controlled trial will be conducted .


In the intervention group we will install an application to a smartphone ; this application will be a reminder to do a physical activity and they have to select whether they have or have n't done a physical activity every day .


This application will be installed for @ weeks .


Data will be measured after and before the application is installed in two groups .


We will measure results @ weeks later when the two groups do n't have the reminder .


The principal outcome used to measure the adherence to physical activity will be the International Physical Activity Questionnaire ; secondary outcomes will be a fun-fitness test and self-report survey about quality of life , self-efficacy and social support .


Samples will be randomized by sealed envelope in two groups , with approximately @ subjects in each group .


It 's important to know that the therapist will be blinded and wo n't know the subjects of each group .


Offering people with ID a multimodal intervention and tool to increase the adherence to a physical activity may increase the levels of physical activity and quality of life .


Such a scheme , if beneficial , could be implemented successfully within public health sense .


We report updated progression-free survival ( PFS ) and overall survival ( OS ) data from a trial that compared capecitabine plus oxaliplatin ( CapeOX ) versus S-@ plus oxaliplatin ( SOX ) for the first-line treatment of metastatic colorectal cancer .


This trial was a randomized , two-armed , non-inferiority phase @ comparison of CapeOX ( capecitabine @ mg/m@ twice daily on days @-@ and oxaliplatin @ mg/m@ on day @ ) versus SOX ( S-@ @ mg/m@ twice daily on days @-@ and oxaliplatin @ mg/m@ on day @ ) .


The primary end point was to show non-inferiority of SOX relative to CapeOX in terms of PFS .


Thus , a follow-up exploratory analysis of PFS and OS was performed .


The intention to treat ( ITT ) population was comprised of @ patients ( SOX arm : @ and CapeOX arm : @ ) .


The updated median PFS was @ months ( @ % CI @-@ @ ) in the SOX group and @ months ( @ % CI @-@ @ ) in the CapeOX group ( hazard ratio -LSB- HR -RSB- , @ -LSB- @-@ @ -RSB- , p = @ ) .


The median OS was @ months ( @ % CI @-@ @ ) in the SOX group and @ months ( @ % CI @-@ @ ) in the CapeOX group ( HR , @ -LSB- @-@ @ -RSB- , p = @ ) .


Subgroup analyses according to principal demographic factors such as sex , age , ECOG ( Eastern Cooperative Oncology Group ) performance status , primary tumor location , measurability , previous adjuvant therapy , number of metastatic organs , and liver metastases showed no interaction between any of these characteristics and the treatment .


Updated survival analysis shows that SOX is similar to CapeOX , confirming the initial PFS analysis .


Therefore , the SOX regimen could be an alternative first-line doublet chemotherapy strategy for patients with metastatic colorectal cancer .


Report long-term outcomes of the NOURISH randomized controlled trial ( RCT ) , which evaluated a universal intervention commencing in infancy to provide anticipatory guidance to first-time mothers on `` protective '' complementary feeding practices that were hypothesized to reduce childhood obesity risk .


The NOURISH RCT enrolled @ mothers ( mean age @ years , SD = @ ) with healthy term infants ( @ % female ) .


Mothers were randomly allocated to usual care or to attend two @-session , @-week group education modules .


Outcomes were assessed @ times : baseline ( infants @ months ) ; @ months after module @ ( infants @ months ) ; @ months after module @ ( infants @ years ) and at @ and @ years of age .


Maternal feeding practices were self-reported using validated questionnaires .


BMI Z-score was calculated from measured child height and weight .


Linear mixed models evaluated intervention ( group ) effect across time .


Retention at age @ years was @ % .


Across ages @ to @ years , intervention mothers reported less frequent use of nonresponsive feeding practices on @ of @ scales .


At @ years , they also reported more appropriate responses to food refusal on @ of @ items ( Ps @ ) .


No statistically significant group effect was noted for anthropometric outcomes ( BMI Z-score : P = @ ) or the prevalence of overweight/obesity ( control @ % vs intervention @ % , P = @ ) .


Anticipatory guidance on complementary feeding resulted in first-time mothers reporting increased use of protective feeding practices .


These intervention effects were sustained up to @ years of age and were paralleled by a nonsignificant trend for lower child BMI Z-scores at all postintervention assessment points .


Dantrolene is neuroprotective in animal models and may attenuate cerebral vasospasm ( cVSP ) in human aneurysmal subarachnoid haemorrhage ( aSAH ) .


We evaluated safety , feasibility and tolerability of intravenous dantrolene ( IV-D ) in patients with aSAH .


In this single-centre , randomised , double blind , placebo-controlled trial , @ patients with aSAH were randomised to IV-D @ mg every @h for @days ( n = @ ) or equiosmolar free water/@ % mannitol ( placebo ; n = @ ) .


Primary safety end points were incidence of hyponatraemia ( sNa@mmol/L ) and liver toxicity ( proportion of patients alanine transaminase , aspartate aminotransferase and AlkPhos > @ upper-limit-of-normal ) .


Secondary end points included tolerability , systemic hypotension and intracranial hypertension .


Efficacy was explored for clinical/radiological cVSP , delayed cerebral ischaemia ( DCI ) , and @-month functional outcomes .


Quantitative analyses of angiograms and daily transcranial Doppler ( TCD ) were performed .


Between IV-D versus placebo , no differences were observed in the primary outcomes ( hyponatremia @ % vs @ % ( p = @ ) ; liver toxicity @ % vs @ % ( p = @ ) ) .


Three patients in the IV-D versus two in the placebo group had severe adverse events possibly attributable to infusion and reached stop criteria : one IV-D patient developed liver toxicity ; two patients in each group developed brain oedema requiring osmotherapy .


The majority of adverse events were not related to infusion ( @ vs @ ( RR @ ; @ % CI @ to @ ; p = @ ) in IV-D vs placebo ) .


No differences in any categorical cVSP outcomes , DCI , @-month outcomes or quantitative angiogram and TCD analyses were seen in this small safety trial not powered to detect efficacy .


In this small trial , IV-D after aSAH was feasible , tolerable and safe .


Antithyroid drug therapy is one of the main medical treatments for Graves ' disease .


There have been conflicting reports as to whether the addition of exogenous L-thyroxine improves remission rates more than antithyroid drugs alone .


This randomized , controlled and prospective clinical trial was undertaken to investigate the long-term outcome of methimazole treatment with or without exogenous L-thyroxine in Chinese patients .


@ patients with Graves ' disease were randomly divided into @ groups and all patients initially received @mg of methimazole daily for at least @ month and then followed the titration - regimen with or without L-thyroxine : group @ ( @mg@mg@mg@mg@mg ) ; group @ ( @mg@mg@mg@mg + L-thyroxine@mg + L-thyroxine ) ; group @ ( @mg@mg@mg@mg + L-thyroxine@mg + L-thyroxine@ @ mg + L-thyroxine ) .


The drug therapy was discontinued after @ months of the final dose .


@ out of @ patients in group @ ( @ % ) , @ out of @ in group @ ( @ % ) and @ out of @ in group @ ( @ % ) had a recurrence of Graves ' disease within @-year follow-up after drug withdrawal .


Survival Analysis showed no significant differences in the remission rates between any @ groups , despite the remission rates in group @ and @ were slightly higher than that in group @ .


The addition of L-thyroxine to methimazole treatment in patients with Graves ' disease neither improves nor prevents the remission or recurrence of Graves ' disease in China .


Effective treatment for hepatitis C virus ( HCV ) genotype @ infection in patients who have not had a sustained virologic response to prior interferon-based therapy represents an unmet medical need .


We conducted a phase @ , randomized , open-label study involving patients infected with HCV genotype @ who had not had a sustained virologic response after treatment with peginterferon and ribavirin , with or without a protease inhibitor .


Patients were randomly assigned to receive the NS@A inhibitor ledipasvir and the nucleotide polymerase inhibitor sofosbuvir in a once-daily , fixed-dose combination tablet for @ weeks , ledipasvir-sofosbuvir plus ribavirin for @ weeks , ledipasvir-sofosbuvir for @ weeks , or ledipasvir-sofosbuvir plus ribavirin for @ weeks .


The primary end point was a sustained virologic response at @ weeks after the end of therapy .


Among the @ patients who underwent randomization and were treated , @ % had cirrhosis and @ % had HCV genotype @a infection .


The rates of sustained virologic response were high in all treatment groups : @ % ( @ % confidence interval -LSB- CI -RSB- , @ to @ ) in the group that received @ weeks of ledipasvir-sofosbuvir ; @ % ( @ % CI , @ to @ ) in the group that received @ weeks of ledipasvir-sofosbuvir and ribavirin ; @ % ( @ % CI , @ to @ ) in the group that received @ weeks of ledipasvir-sofosbuvir ; and @ % ( @ % CI , @ to @ ) in the group that received @ weeks of ledipasvir-sofosbuvir and ribavirin .


No patient discontinued treatment owing to an adverse event .


The most common adverse events were fatigue , headache , and nausea .


Treatment with a once-daily , single-tablet regimen of ledipasvir and sofosbuvir resulted in high rates of sustained virologic response among patients with HCV genotype @ infection who had not had a sustained virologic response to prior interferon-based treatment .


( Funded by Gilead Sciences ; ION-@ ClinicalTrials.gov number , NCT@ . )


We conducted a qualitative investigation of patients with type @ diabetes to determine their perceived facilitators and barriers to exercise at multiple time points while enrolled in a randomized exercise trial including aerobic , resistance or combined exercise .


We explored differences in these themes over time , between intervention groups and by adherence level after intervention .


Interviews were conducted by telephone at @ weeks ( run-in period ) , and at @ ( midintervention ) , @ ( end of intervention ) and @ months ( maintenance ) after enrollment to assess factors that facilitated and hampered adherence to the exercise program .


Audiotapes were transcribed verbatim and subjected to content analysis .


Participants ( n = @ ) with type @ diabetes engaged in the interviews .


Social support from family and the trainer , future health benefits , a sense of well-being and perceived fitness improvements were exercise facilitators .


Experiencing illness or injury , work commitments and inclement weather were highlighted barriers .


A sense of well-being , fitness improvements and enjoyment frequently were expressed by participants assigned to the combined and resistance exercise conditions .


Participants who maintained prescribed exercise levels tended to be engaged in resistance exercise , and spoke of support from their personal trainers , the importance of strategies and enjoyment more frequently than those who did not maintain their exercise level .


Exercise maintainers also cited more facilitators ; no differences were found for barriers .


Patients with type @ diabetes require social support , including continued contact with exercise specialists .


Patients need assistance with motivational enhancement and strategies to increase facilitators to maintain exercise behaviour .


Incorporating resistance exercise improves well-being and enjoyment-@ important factors linked to exercise maintenance .


Danshen ( Salvia miltiorrhiza ) and Gegen ( Radix puerariae ) ( D&G ) are two herbs frequently used for the treatment of angina and other cardiac symptoms in Chinese materia medica .


Recent studies have demonstrated their cardio-protective and anti-atherosclerosis effects .


Earlier we have conducted two clinical trials in @ and @ which demonstrated such effects in extremely high risk patients .


The aim of the study was to demonstrate the safety and effectiveness of D&G in the prevention of atherosclerosis in postmenopausal women with early hypercholesterolemia .


The study was designed as a randomized , double-blinded , placebo-controlled trial with a @-month treatment period .


A population based sample of @ postmenopausal women aged @-@ were included in the trial .


Only women who experienced menopause for more than @ months were recruited .


The eligible subjects were randomized to take the D&G preparation ( two capsules ) , or image-identical placebo capsules ( two capsules ) daily , in a double-blind and parallel fashion for @ month .


The postmenopausal women with mild hypercholesterolemia ( mean age @ @ of treatment group and @ @ years of placebo group ) were randomized to the D&G group or placebo group for trial treatment .


Carotid intima-media thickness ( IMT ) was used as the surrogate marker and was measured using high resolution ultrasound .


Lipid profile was also tested .


Baseline characteristics were comparable between the two groups .


After @ months , there were no significant changes in the blood pressures and general biochemical profiles in both groups , however , there was a remarkable decrease in serum low density lipoprotein ( LDL ) cholesterol ( -@ % ) and total cholesterol ( TC ) ( -@ % ) in the D&G group compared with the placebo group ( -@ % and -@ % ) when compared with the baseline .


The carotid intima-media thickness ( IMT ) decreased @ % from baseline in the D&G group ( p < @ ) but the decrease was only @ % in the placebo treatment group ( p = @ ) after @ months treatment .


Twelve adverse events were reported ( six in placebo group and six in D&G group ) but none of them was directly relevant to the study herbal preparation .


Postmenopausal women with early hypercholesterolemia tolerated D&G well .


D&G improved the carotid intima thickness , lowered LDL and total cholesterol .


D&G therefore can be recommended for the prevention of atherosclerosis in postmenopausal women with hypercholesterolemia .


To investigate the effect of creatine ( CR ) supplementation on the acute interference induced by aerobic exercise on subsequent maximum dynamic strength ( @RM ) and strength endurance ( SE , total number of repetitions ) performance .


Thirty-two recreationally strength-trained men were submitted to a graded exercise test to determine maximal oxygen consumption ( VO@max : @ @ ml kg ( -@ ) min ( -@ ) ) , anaerobic threshold velocity ( ATv : @ @ km h ( -@ ) ) , and baseline performance ( control ) on the @RM and SE ( @ @ % @RM to failure ) tests .


After the control tests , participants were randomly assigned to either a CR ( @ g day ( -@ ) for @ days followed by @ g day ( -@ ) throughout the study ) or a placebo ( PL-dextrose ) group , and then completed @ experimental sessions , consisting of a @-km run on a treadmill either continuously ( @ % ATv ) or intermittently ( @:@ min at vVO@max ) followed by either a leg - or bench-press SE/@RM test .


CR was able to maintain the leg-press SE performance after the intermittent aerobic exercise when compared with C ( p > @ ) .


On the other hand , the PL group showed a significant decrease in leg-press SE ( p @ ) .


CR supplementation significantly increased bench-press SE after both aerobic exercise modes , while the bench-press SE was not affected by either mode of aerobic exercise in the PL group .


Although small increases in @RM were observed after either continuous ( bench press and leg press ) or intermittent ( bench press ) aerobic exercise in the CR group , they were within the range of variability of the measurement .


The PL group only maintained their @RM .


In conclusion , the acute interference effect on strength performance observed in concurrent exercise may be counteracted by CR supplementation .


Nasogastric rehydration therapy ( NGRT ) is the recommended therapy in moderately dehydrated children with gastroenteritis and refusal to drink , since it is supposed to be as effective if not better than intravenous rehydration therapy ( IVRT ) .


However , in clinical practice IVRT is often favored .


We conducted a clinical trial to determine whether IVRT is not inferior to NGRT .


Children @ months to @ years of age with moderate dehydration and refusal to drink secondary to gastroenteritis were recruited .


After clinical assessment of the degree of dehydration , patients were assigned randomly to receive either IVRT or NGRT over @h on the hospital ward .


Recruitment did not yield the estimated number of patients .


Mainly , non-enrollment was due to failure to obtain parental consent because IVRT was expected .


@ patients were enrolled in the study , @ were randomized to NGRT and @ to IVRT .


There was no difference between IVRT and NGRT groups concerning length of hospital stay ( @ days vs. @ days ) , success of rehydration ( @ vs. @ % ) and adverse events .


Since we had to terminate the study ahead of schedule due to a low recruiting rate , our results are not reliable .


However , data from the literature shows that the widespread described superiority of NGRT over IVRT is seriously influenced by studies from developing countries questioning the applicability of the results to a setting available in high-income countries nowadays .


Our study demonstrates the difficulties performing such a study in a high-income country to come to an objective and clearly evident final conclusion .


The aim of this study was to compare radiological results of total knee arthroplasties ( TKAs ) performed with patient-specific computed tomography ( CT ) - based instrumentation and conventional technique .


The main study hypothesis was that CT-based patient-specific instrumentation ( PSI ) increases the accuracy of TKA .


A prospective , randomized controlled trial was carried out between January and December @ .


A group of @ patients who met the inclusion and exclusion criteria were enrolled in this study and randomly assigned to an experimental or control group .


The experimental group comprised @ patients operated on with the aid of the Signature CT-based implant positioning system .


The control group consisted of @ patients operated on using conventional instrumentation .


The radiographic evaluation of implant positioning and overall coronal alignment was performed @ months after the surgery by using standing anteroposterior radiographs of the entire lower limb and standard lateral radiographs .


Of the @ patients initially enrolled for the study , @ were included in the subsequent analyses .


There were no statistically significant differences between groups in respect to coronal and sagittal component positioning and overall coronal alignment , except for frontal tibial component positioning .


For this parameter , better results were obtained in the control group , with borderline statistical significance .


Our study did not reveal superiority of the CT-based PSI system over conventional instrumentation .


Further high-quality investigations of patient-specific systems are absolutely indispensable to assess their utility for TKA .


In our opinion , the surgeon applying PSI technology is required to have advanced knowledge and considerable experience with the conventional method .


Previous studies on the prognostic value of clinical and MRI parameters for the time to return to play ( TTRTP ) in acute hamstring injuries showed only limited to moderate evidence for the various investigated parameters .


Some studies had multiple methodological limitations , including retrospective designs and the use of univariate analysis only .


The aim of this study was to assess the prognostic value of clinical and MRI parameters for TTRTP using multivariate analysis .


@ clinical and MRI parameters were prospectively investigated for an association with TTRTP in @ non-professional athletes with MRI positive hamstring injuries undergoing a standardised rehabilitation programme .


The association between possible prognostic parameters and TTRTP was assessed with a multivariate linear regression model .


Parameters that had a p value < @ on univariate testing were included in this model .


@ athletes were available for analysis .


A total of nine variables met the criteria for the multivariate analysis : intensity of sports , level of sports , self-predicted TTRTP by the athlete , length of discomfort on palpation , deficit in passive straight leg raise , pain score on isometric knee flexion , isometric knee flexion strength deficit and distance of the proximal pole of the MRI hyperintensity to the tuber ischiadicum .


Of these , only self-predicted TTRTP by the athlete and a passive straight leg raise deficit remained significantly associated with TTRTP after stepwise logistic regression .


The clinical parameters self-predicted TTRTP and passive straight leg raise deficit are independently associated with the TTRTP .


MRI parameters in grade @ and @ hamstring injuries , as described in the literature , are not associated with TTRTP .


For clinical practice , prognosis of the TTRTP in these injuries should better be based on clinical parameters .


Effective O@ delivery and accurate end-tidal CO@ ( ETCO@ ) sampling are essential features of nasal cannulae ( NCs ) in patients with compromised respiratory status .


We studied @ NC designs : bifurcated nasal prongs ( NPs ) with O@ delivery and CO@ sensing in both NPs ( Hudson ) , separate O@/CO@ NPs ( Salter ) , and CO@ sensing in NPs with cloud O@ delivery outside the NPs via multi vents ( Oridion ) and dual vents ( Medline ) .


We hypothesized that design differences between NCs would influence O@ delivery and ETCO@ detection .


Forty-five healthy volunteers , @ to @ years , participated in an unrestricted , randomized block design , each subject serving as their own control in a @-period crossover study design of @ NCs during one session .


Monitoring included electrocardiogram , posterior pharynx O@ sampling from a Hauge Airway ( Sharn Anesthesia Products , Tampa , FL ) , and NC ETCO@ .


In @ volunteers , radial artery blood was sampled from a catheter for partial pressures of O@ and carbon dioxide ( PaO@ and PaCO@ ) determination .


Per randomization , each NC was positioned , and data were collected over @ minutes ( ETCO@ , pharyngeal O@ , PaO@ , and PaCO@ ) during room air and during O@ fresh gas flows ( FGFs ) of @ , @ , and @ Lpm .


Statistical analyses were performed with SAS Analytics Pro , Version @ , and JMP Statistical Software , Version @ ( SAS Institute Inc. , Cary , NC ) , significance at P < @ .


Blood gas analyses indicated PaCO@ during steady state at each experimental time period remained unchanged from physiologic baseline .


PaO@ did not differ between NC devices at baseline or @ Lpm O@ .


The PaO@ at @ Lpm from the separate NPs and bifurcated NCs was significantly higher than the multi-vented NC .


Pharyngeal O@ with the NC with separate NPs was significantly higher than multivented and dual-vented cloud delivery NCs at @ , @ , and @ Lpm FGF .


Pharyngeal O@ with the NC with bifurcated NPs was significantly higher than the multi-vented NC at @ Lpm , and higher than cloud delivery NCs at @ and @ Lpm FGF .


ETCO@ was significantly lower with the NC with bifurcated NPs compared to the other @ NCs , consistent with errant CO@ tracings at higher FGF .


NCs provide supplemental inspired O@ concentrations for patients with impaired pulmonary function .


Accurate measures of ETCO@ are helpful in assessing respiratory rate and determining whether CO@ retention is occurring from hypoventilation .


These findings suggest the NC with separate NPs was the most effective in delivering O@ and the most consistent at providing reliable CO@ waveforms at higher FGFs .


Protein supplementation has been shown to reduce the increases in intrahepatic triglyceride ( IHTG ) content induced by acute hypercaloric high-fat and high-fructose diets in humans .


To assess the effect of a @-wk iso-energetic high protein-low carbohydrate ( HPLC ) diet compared with an iso-energetic high carbohydrate-low protein ( HCLP ) diet on IHTG content in healthy non-obese subjects , at a constant body weight .


Seven men and nine women -LSB- mean SD age : @ @ y ; BMI : @ @ kg/m@ -RSB- were randomly allocated to a HPLC -LSB- @/@/@ % of energy ( En % ) from protein/carbohydrate/fat -RSB- or a HCLP ( @/@/@ En % ) diet by stratification on sex , age and BMI .


Dietary guidelines were prescribed based on individual daily energy requirements .


IHTG content was measured by @H-magnetic resonance spectroscopy before and after the dietary intervention .


IHTG content changed in different directions with the HPLC ( CH@H@O : @ @ to @ @ ; IHTG % : @ @ % to @ @ % ) compared with the HCLP diet ( CH@H@O : @ @ vs. @ @ ; IHTG % : @ @ % vs. @ @ % ) , which resulted in a lower IHTG content in the HPLC compared with the HCLP diet group after @ weeks , which almost reached statistical significance ( P = @ ) .


A HPLC vs. a HCLP diet has the potential to preserve vs. enlarge IHTG content in healthy non-obese subjects at a constant body weight .


We compared the clinical efficacy of barium therapy and conservative therapy in preventing recurrence in patients with diverticular bleeding .


Previous case reports have indicated that barium impaction therapy provides initial hemostasis for diverticular bleeding and prevention against rebleeding .


After spontaneous cessation of bleeding , patients were randomly assigned to conservative treatment ( n = @ ) or high-dose barium impaction therapy ( n = @ ) .


Patients were followed up for @ year after enrollment of the last patient .


The main outcome measure was rebleeding .


Median follow-up period was @ days .


The probability of rebleeding at @-day , @-day , @-year , and @-year follow-up in all patients was @ % , @ % , @ % , and @ % , respectively .


By group , probability at @ year was @ % in the conservative group and @ % in the barium group ( log-rank test , P = @ ) .


After adjustment for a history of hypertension , the hazard ratio of rebleeding in the barium group was @ ( @ % confidence interval , @-@ @ ) .


No complications or laboratory abnormalities due to barium therapy were observed .


Compared with the conservative group , the barium group had significantly ( P < @ ) fewer hospitalizations per patient ( @ vs @ ) , units of blood transfused ( @ vs @ ) , colonoscopies ( @ times vs @ times ) , and hospital stay days ( @ days vs @ days ) during the follow-up period .


No patients died and none required angiographic or surgical procedures in either group .


High-dose barium impaction therapy was effective in the long-term prevention of recurrent bleeding , and reduced the frequency of rehospitalization and need for blood transfusion and colonoscopic examination .


ClinicalTrials.gov Identifier , UMIN @ .


Fiber intakes in developed countries are generally below those recommended by relevant authorities .


Given that many people consume fiber-depleted refined-grain products , adding functional fiber will help to increase fiber intakes .


The objective of the study was to determine metabolic and sensory effects of adding fiber to bread .


A double-blind pair of randomized crossover trials with a two-week washout in which two fiber-containing breads were compared with control bread .


The functional fiber ( fruit fiber and FibreMax ) was added to yield @ g fiber per serve ( two slices ) .


Eighty participants ( n = @ fruit fiber and n = @ FibreMax ) consumed one serve of bread ( fiber or control ) followed three hours later by a pasta meal consumed ad libitum .


Outcome measures included glycemia , satiety , palatability , gastrointestinal wellbeing , visual appeal and subsequent energy intake of the pasta meal .


Multivariate regression was undertaken to test for differences between treatment and control for blood glucose , satiety , and cumulative energy intake .


Satiety responses were also compared by splitting the data into an immediate response after eating ( @-@ min ) and a return to hunger analysis ( @-@ min ) .


A Wilcoxon sign rank test was used for the first component ( @-@ min ) and Wilcoxon matched-pairs signed-rank test for the second component ( @-@ min ) .


Between treatment differences for gastrointestinal wellbeing were tested using Pearson 's chi-square test or Fisher 's exact test .


Consumption of the fruit fiber bread reduced postprandial glycemia by @ % ( @ % CI @ to @ ; P = @ ) and cumulative energy intake by @ kJ ( @ % CI @ to @ ; P = @ ) .


There was little influence on satiety and the bread was rated as having poor taste and smell whilst generating feelings of nausea in some participants .


FibreMax enriched bread reduced glycemia by @ % ( @ % CI @ to @ ; P = @ ) without influence on energy intake or satiety .


Apart from a lower visual appeal , the FibreMax bread was palatable .


Neither bread caused gastrointestinal discomfort related to flatulence or bloating .


Enriching bread with @ g of functional fiber per serve is feasible although reformulation is needed to create not only an acceptable bread , but a desirable product .


To investigate the efficacy and tolerability of albiglutide , a weekly glucagon-like peptide-@ receptor agonist , when added to metformin and glimepiride in a triple therapy regimen in people with type @ diabetes mellitus .


This was a @-week , randomized , double-blind , parallel-group , multicentre study .


In the present paper we describe the primary results , namely those at @weeks .


Adult participants ( n = @ ) were randomly assigned to albiglutide ( @mg/week ) , pioglitazone ( @mg/day ) or placebo .


If needed , blinded uptitration of albiglutide ( to @mg/week ) and pioglitazone ( to @mg/day ) was allowed .


The participant 's current dose of metformin ( > @mg/day ) was maintained throughout .


The glimepiride dose ( @mg/day ) , standardized before randomization , could be decreased if persistent hypoglycaemia occurred .


The week @ model-adjusted difference in change of glycated haemoglobin ( primary endpoint ) for albiglutide versus placebo was -@ -LSB- @ % confidence interval ( CI ) -@ , -@ -RSB- % - units ( p < @ ) , and for albiglutide versus pioglitazone it was @ ( @ % CI @ , @ ) % - units ; therefore , not non-inferior .


In the albiglutide group only , fasting plasma glucose reduced rapidly in the first @weeks .


Confirmed hypoglycaemia occurred in @ % of participants on albiglutide , @ % on pioglitazone and @ % on placebo .


The mean ( standard error ) weight change was -@ ( @ ) kg with albiglutide , +@ ( @ ) kg ( p < @ ) with pioglitazone , and -@ ( @ ) kg with placebo and serious adverse events occurred in @ , @ and @ % of participants in the respective groups .


Injection site reactions occurred in @ % of participants on albiglutide and resulted in treatment discontinuation for four participants ( @ % ) .


Albiglutide , as part of triple therapy , provided effective glucose-lowering and was generally well tolerated .


Irritable bowel syndrome with diarrhoea ( IBS-D ) is particularly debilitating due to urgency and episodic incontinence .


Some @-hydroxytryptamine @ ( @-HT@ ) receptor antagonists ( @-HT@RAs ) have proven effective but have serious side effects .


Ondansetron , also a @-HT@RA , has been widely used as an antiemetic with an excellent safety record for over two decades .


Our aim was to assess its effectiveness in IBS-D .


@ patients meeting Rome III criteria for IBS-D entered a randomised , double-blind , placebo-controlled crossover study of @weeks of ondansetron @mg versus placebo with dose titration allowed , up to two tablets three times daily in the first @weeks .


Patients completed daily diaries documenting stool consistency using the Bristol Stool Form score .


Gut transit was measured in the last week of each treatment .


The primary endpoint was average stool consistency in the last @weeks of treatment .


Ondansetron significantly improved stool consistency ( mean difference in stool form between ondansetron and placebo -@ , @ % CI -@ to -@ , p < @ ) .


Compared with placebo , patients on ondansetron experienced fewer days with urgency ( p < @ ) , lower urgency scores ( p < @ ) , reduced frequency of defaecation ( p = @ ) and less bloating ( p = @ ) , although pain scores did not change significantly .


IBS symptom severity score fell more with ondansetron than placebo ( @ vs @ , p = @ ) .


@ % reported adequate relief with ondansetron but not placebo compared with @ % reporting relief with placebo but not ondansetron , relative risk @ , @ % CI @ to @ , p < @ .


Ondansetron relieves some of the most intrusive symptoms of IBS-D , namely loose stools , frequency and urgency .


Because many sports concussions happen during school-sponsored sports events , most state concussion laws specifically hold schools accountable for coach training and effective concussion management practices .


Brain @ : The Concussion Playbook is a Web-based intervention that includes training in sports concussion for each member of the school community , presents guidelines on creating a concussion management team , and includes strategies for supporting students in the classroom .


The group randomized controlled trial examined the efficacy of Brain @ in managing sports concussion .


Participating high schools ( N = @ ) were randomly assigned to the Brain @ intervention or control .


Fall athletes and their parents completed online training , and Brain @ school administrators were directed to create concussion management policy and procedures .


Student athletes and parents at Brain @ schools significantly outperformed those at control schools on sports concussion knowledge , knowledge application , and behavioral intention to implement effective concussion management practices .


Students who had concussions in Brain @ schools received more varied academic accommodations than students in control schools .


Brain @ can help schools create a comprehensive schoolwide concussion management program .


It requires minimal expenditures and offers engaging and effective education for teachers , coaches , parents , and students .


To evaluate the effects of canagliflozin , a sodium glucose co-transporter @ inhibitor , on body weight in overweight and obese subjects ( body mass index -LSB- BMI -RSB- @ and < @ kg/m ( @ ) ) .


This @-week , Phase @b , randomized , double-blind study enrolled @ subjects without diabetes mellitus who received canagliflozin @ , @ , or @ mg or placebo once daily .


The primary endpoint was the percent change in body weight from baseline through Week @ .


Canagliflozin increased urinary glucose excretion in a dose-dependent manner and produced statistically significant reductions in body weight compared with placebo ( least squares mean percent changes from baseline of -@ % , -@ % , -@ % , and -@ % with canagliflozin @ , @ , and @ mg and placebo ; P < @ for all comparisons ) .


Overall adverse event ( AE ) rates were similar across groups .


Canagliflozin was associated with higher rates of genital mycotic infections in women , which were generally mild and led to few study discontinuations .


Osmotic diuresis-related AE rates were low and similar across groups .


In overweight and obese subjects without diabetes mellitus , canagliflozin significantly reduced body weight compared with placebo and was generally well tolerated .


There have been no data on sublingual immunotherapy ( SLIT ) in Brazilian patients sensitized to house dust mites .


This study aimed to evaluate the mucosal/systemic antibody response changes and clinical efficacy after SLIT using Dermatophagoides pteronyssinus ( Dpt ) allergens with or without bacterial extracts in mite-allergic Brazilian children .


Patients with allergic rhinitis and asthma were selected for a double-blind , placebo-controlled trial randomized to three groups : DPT ( Dpt extract , n = @ ) , DPT+MRB ( Dpt plus mixed respiratory bacterial extracts , n = @ ) , and Placebo ( n = @ ) .


Total symptom and medication scores for rhinitis/asthma , skin prick test ( SPT ) to Dpt , and measurements of Dpt - , Der p @ - , Der p @-specific serum IgE , IgG@ , IgG@ , and specific salivary IgA were evaluated at baseline and after @ and @ months of treatment .


A significant long-term decline in total symptom/medication scores was observed only in active groups ( DTP and DPT+MRB ) .


There was no significant change in SPT results in all groups .


SLIT using Dpt allergen alone induced increased levels of serum IgG@ to Dpt , Der p @ , and Der p @ , serum IgG@ and salivary IgA to Dpt and Der p @ .


SLIT with Dpt plus bacterial extracts was able to decrease IgE levels , particularly to Der p @ , to increase salivary IgA levels to Der p @ , but had no changes on specific IgG@ and IgG@ levels .


All children undergoing SLIT showed clinical improvement , but a long-term reduction in symptom/medication scores with modulation of mucosal/systemic antibody responses were seen only in active groups ( DPT and DPT+MRB ) .


The aim of this study was to test the hypothesis that intensive glycaemic control ( INT ) and higher plasma C-peptide levels in patients with poorly controlled diabetes would be associated with better eye outcomes .


The incidence and progression of diabetic retinopathy ( DR ) was assessed by grading seven-field stereoscopic fundus photographs at baseline and @ years later in @ of @,@ participants in the Veterans Affairs Diabetes Trial ( VADT ) .


After adjustment for all covariates , risk of progression ( but not incidence ) of DR increased by @ % for each @ % increase in baseline HbA@c ( OR @ ; @ % CI @ , @ ; p = @ ) .


Neither assignment to INT nor age was independently associated with DR in the entire cohort .


However , INT showed a biphasic interaction with age .


The incidence of DR was decreased in INT participants @ years of age ( OR @ ; @ % CI @ , @ ) but increased in those @ years old ( OR @ ; @ % CI @ , @ ) ( p = @ ) .


The incidence of DR was reduced by @ % with each @ pmol/ml increment in baseline C-peptide ( OR @ ; @ % CI @ , @ ; p = @ ) .


Baseline C-peptide was also an independent inverse risk factor for the progression of DR , with a reduction of @ % with each @ pmol/ml increase in C-peptide ( OR @ ; @ % CI @ , @ ; p = @ ) .


Poor glucose control at baseline was associated with an increased risk of progression of DR. INT was associated with a decreased incidence of DR in younger patients but with an increased risk of DR in older patients .


Higher C-peptide at baseline was associated with reduced incidence and progression of DR.


The need for long preoperative fasting has been questioned .


Recent data shows that intake of an oral carbohydrate-containing clear fluid prior to anaesthesia is safe and may have a positive impact on recovery and metabolic status and could improve glucose tolerance .


Such solutions are routinely used in adults but not children .


The aim of this study was to evaluate the safety , tolerance and influence of oral carbohydrate on selected metabolic parameters in children .


With ethics committee approval and parental informed consent , @ children , aged @-@ years , ASA status I or II , scheduled for abdominal or thoracic surgery were randomised either to Group @ - receiving a @ % carbohydrate-containing drink ( @ mL kg ( -@ ) the evening before surgery and two hours before anaesthesia ) , or the control Group @ - fasting .


Serum glucose and insulin concentration were measured four times : before and after anaesthesia , in the evening after surgery , and the following morning .


IGF-@ concentration was measured once , before surgery .


Insulin resistance was assessed by the HOMA-IR equation .


Oral carbohydrate solution was well tolerated and no adverse events were noted .


Glucose concentrations were within the normal range in both groups .


Insulin concentration did not show significant differences between groups , however before surgery it tended to be lower in Group @ .


Insulin resistance after surgery was significantly higher in Group @ ( @ vs. @ , P = @ ) , also the increase in insulin resistance after operation was significant only in the control group ( P = @ ) .


Oral carbohydrates are safe , well tolerated and do not cause any perioperative adverse events .


They seem to improve postoperative metabolism by decreasing insulin resistance .


To investigate the effects of magnesium sulphate on succinylcholine-induced fasciculation in patients during the induction of general anaesthesia .


The double-blind randomised clinical trial was conducted in @ at Tohid and Besat Hospitals in Sanandaj , Iran , on patients who were candidates for surgery under general anaesthesia .


Patients were selected and divided into two equal groups of cases and controls using block randomisation .


The cases received magnesium sulphate , while the controls received normal saline .


SPSS @ was used for statistical analysis .


Of the @ subjects in the study , @ ( @ % ) were men and @ ( @ % ) were women ( p < @ ) .


The mean age of the two groups were @ @ years and @ @ years ( p < @ ) .


There was significant difference between the two groups in terms of the degree of fasciculation and muscle fasciculation ( p < @ ) .


The difference between potassium levels in the two groups was not significant before anaesthesia ( p > @ ) , but it was significant after anaesthesia ( p < @ ) .


Magnesium sulphate can prevent and reduce the degree of fasciculation after anaesthesia .


Therefore it can be used to prevent fasciculation .


Schools provide a natural context to promote children 's mental health .


However , there is a need for more evidence-based , high quality school intervention programs combined with an accurate evaluation of their general effectiveness and effectiveness of specific intervention methods .


The aim of this paper is to present a study protocol of a cluster randomized controlled trial evaluating the `` Together at School '' intervention program .


The intervention program is designed to promote social-emotional skills and mental health by utilizing whole-school approach and focuses on classroom curriculum , work environment of school staff , and parent-teacher collaboration methods .


The evaluation study examines the effects of the intervention on children 's socio-emotional skills and mental health in a cluster randomized controlled trial design with @ ) an intervention group and @ ) an active control group .


Altogether @ primary school participated at baseline .


A multi-informant setting involves the children themselves , their parents , and teachers .


The primary outcomes are measured using parent and teacher ratings of children 's socio-emotional skills and psychological problems measured by the Strengths and Difficulties Questionnaire and the Multisource Assessment of Social Competence Scale .


Secondary outcomes for the children include emotional understanding , altruistic behavior , and executive functions ( e.g. working memory , planning , and inhibition ) .


Secondary outcomes for the teachers include ratings of e.g. school environment , teaching style and well-being .


Secondary outcomes for both teachers and parents include e.g. emotional self-efficacy , child rearing practices , and teacher-parent collaboration .


The data was collected at baseline ( autumn @ ) , @ months after baseline , and will be collected also @ months after baseline from the same participants .


This study protocol outlines a trial which aims to add to the current state of intervention programs by presenting and studying a contextually developed and carefully tested intervention program which is tailored to fit a national school system .