Patients receiving chemotherapy followed by involved field radiotherapy had a significant benefit on event-free survival ( hazards ratio -LSB- HR -RSB- = @ , @ % confidence interval -LSB- CI -RSB- : @ to @ ; P = @ ) , but not improved overall survival ( HR = @ , @ % CI : @ to @ ; P = @ ) at @ years , in relation to those in the chemotherapy alone arm .


There were great differences in the reporting of cumulative incidences of toxicity .


Chemotherapy followed by involved field radiotherapy , as compared with chemotherapy alone , is associated with better event-free survival , but no survival benefit is observed for patients for limited-stage aggressive non-Hodgkin 's lymphoma .


These results needed to be confirmed by high quality trials and further studies in the East .


Transcranial direct current stimulation ( tDCS ) is a neuromodulatory intervention with recent clinical trials showing promising results in major depression treatment .


Although tDCS has some appealing characteristics ( e.g. , low cost , ease of use , and relatively benign profile of adverse effects ) , one important drawback of the technique is the need to deliver consecutive , repeated sessions for several weekdays .


However , no study investigated whether absences during this acute treatment phase impact on tDCS efficacy , and , if so , whether absences should be considered dropouts , therefore increasing attrition .


To examine this issue , we used data from a randomized , factorial , sham-controlled tDCS study that recruited @ depressed patients .


In this trial , the acute treatment phase consisted of ten consecutive sessions delivered once daily from Monday to Friday ; two nonconsecutive missed visits were allowed , with extra tDCS sessions being performed to complete the original number of sessions .


Our main finding was that the procedure of granting one to two absences during the acute treatment phase did not impact on tDCS antidepressant efficacy .


Moreover , out of @ completers , only @ ( @ % ) patients presented no missing visits and @ ( @ % ) presented two absences .


These patients did not differ in clinical and demographic characteristics ; thus , absences were probably circumstantial ( e.g. , traffic congestion , personal obligations ) .


Absences during the acute tDCS treatment phase are common , which support the use of flexible schedules in future tDCS trials as to minimize attrition .


Also , further studies should access whether higher number of absences can compromise optimal tDCS efficacy .


To evaluate postural changes and the distribution of plantar pressures in patients with cystic fibrosis ( CF ) .


We also sought to evaluate the effects of an educational guideline for physical activity on body posture in children and adolescents with CF.


This was a @-phase study of individuals between age @ and @ years .


Phase I was a cross-sectional study in which healthy subjects were selected for postural evaluation and baropodometry , aiming to perform a later comparison with patients with CF. In phase II , we performed a randomized controlled clinical trial to assess the influence of the exercise guideline on the postural changes .


Patients were assigned to @ groups : control and intervention .


The intervention consisted of a handbook with instructions for aerobic exercise and stretching .


Main outcomes were postural abnormalities , plantar pressure distribution , and lung function .


In phase I , @ patients with CF and @ healthy matched individuals were included .


No significant baseline differences were identified .


Children with CF presented more postural deviations compared with healthy subjects ( P < @ ) , as to alignment of the head , shoulder girdle , and pelvis , increased cervical lordosis , and lateral chest distance .


In phase II ( n = @ ) , there were no baseline differences between groups .


The intervention caused ( P < @ ) a decrease in cervical lordosis , thoracic kyphosis , lumbar lordosis , lateral chest distance , and abdominal protrusion , as well as in the baropodometric mean pressure and contact area .


Children and adolescents with CF present postural changes when compared with healthy individuals .


The educational guideline for exercise practice helped to improve posture , preventing the progression of some postural disorders .


To evaluate the efficacy and safety of adalimumab in patients with active nonpsoriatic peripheral spondyloarthritis ( SpA ) .


ABILITY-@ is an ongoing phase III , multicenter study of adalimumab treatment .


Eligible patients age @ years fulfilled the Assessment of SpondyloArthritis international Society ( ASAS ) classification criteria for peripheral SpA , did not have a prior diagnosis of psoriasis , psoriatic arthritis ( PsA ) , or ankylosing spondylitis ( AS ) , and had an inadequate response or intolerance to nonsteroidal antiinflammatory drugs ( NSAIDs ) .


Patients were randomized @:@ to receive adalimumab @ mg every other week or matching placebo for @ weeks , followed by a @-week open-label period .


The primary end point was the proportion of patients achieving @ % improvement in disease activity according to the Peripheral SpA Response Criteria ( PSpARC@ ) at week @ .


This was defined as @ % improvement from baseline ( @-mm absolute improvement on a visual analog scale ) in patient 's global assessments of disease activity and pain , and @ % improvement in at least one of the following features : swollen joint and tender joint counts , total enthesitis count , or dactylitis count .


Adverse events were recorded throughout the study .


In total , @ patients were randomized to a treatment group , of whom @ were randomized to receive placebo and @ to receive adalimumab .


Baseline demographics and disease characteristics were generally similar between the @ groups .


At week @ , a greater proportion of patients receiving adalimumab achieved a PSpARC@ response compared to patients receiving placebo ( @ % versus @ % ; P = @ ) .


Overall , improvement in other outcomes was greater in the adalimumab group compared to the placebo group .


The rates of adverse events were similar in both treatment groups .


Treatment with adalimumab ameliorated the signs and symptoms of disease and improved physical function in patients with active nonpsoriatic peripheral SpA who exhibited an inadequate response or intolerance to NSAIDs , with a safety profile consistent with that observed in patients with AS , PsA , or other immune-mediated diseases .


To determine whether the probiotic Lactobacillus reuteri DSM @ reduces crying or fussing in a broad community based sample of breastfed infants and formula fed infants with colic aged less than @ months .


Double blind , placebo controlled randomised trial .


Community based sample ( primary and secondary level care centres ) in Melbourne , Australia .


@ breastfed infants or formula fed infants aged less than @ months meeting Wessel 's criteria for crying or fussing : @ were randomised to receive probiotic and @ to receive placebo .


Oral daily L reuteri ( @ @ ( @ ) colony forming units ) versus placebo for one month .


The primary outcome was daily duration of cry or fuss at @ month .


Secondary outcomes were duration of cry or fuss ; number of cry or fuss episodes ; sleep duration of infant at @ , @ , and @ days , and @ and @ months ; maternal mental health ( Edinburgh postnatal depression subscale ) ; family functioning ( paediatric quality of life inventory ) , parent quality adjusted life years ( assessment of quality of life ) at @ and @ months ; infant functioning ( paediatric quality of life inventory ) at @ months ; infant faecal microbiota ( microbial diversity , colonisation with Escherichia coli ) , and calprotectin levels at @ month .


In intention to treat analyses the two groups were compared using regression models adjusted for potential confounders .


Of @ infants randomised from August @ to August @ , @ ( @ % ) were retained to primary outcome ; of these , a subset was analysed for faecal microbial diversity , E coli colonisation , and calprotectin levels .


Adherence was high .


Mean daily cry or fuss time fell steadily in both groups .


At @ month , the probiotic group cried or fussed @ minutes more than the placebo group ( @ % confidence interval @ to @ minutes , P = @ ) ; this mainly reflected more fussing , especially for formula fed infants .


The groups were similar on all secondary outcomes .


No study related adverse events occurred .


L reuteri DSM @ did not benefit a community sample of breastfed infants and formula fed infants with colic .


These findings differ from previous smaller trials of selected populations and do not support a general recommendation for the use of probiotics to treat colic in infants .


The estimated prevalence of lumbar radiculopathy has been described as @ per @,@ cases of low back pain .


There are various surgical and nonsurgical modalities for treating lumbar disc herniation or radicular pain , including epidural injections .


Epidural injection administration routes include transforaminal , interlaminar , and caudal approaches .


The transforaminal approach requires the smallest volume to reach the primary site of pathology .


Systematic reviews have yielded highly variable results , but a recent systematic review showed no significant difference among the @ approaches .


A randomized , controlled , double blind , active control trial .


An interventional pain management practice , a private specialty referral center in the United States .


To assess the effectiveness of transforaminal epidural injections of local anesthetic with or without steroids in managing chronic low back and lower extremity pain in patients with disc herniation and radiculitis .


One hundred twenty patients were randomly assigned to @ groups : Group I received @ mL of @ % preservative-free lidocaine , followed by @ mL of sodium chloride solution .


Group II received @ % lidocaine , followed by @ mg , or @ mL of betamethasone .


The sodium chloride solution and betamethasone were either clear liquids or were provided in opaque-covered syringes .


The primary outcome measure was significant improvement ( at least @ % ) measured by the average Numeric Rating Scale ( NRS ) and the Oswestry Disability Index @ ( ODI ) .


Secondary outcome measures were employment status and opioid intake .


At @ years there was significant improvement in all participants in @ % who received local anesthetic alone and @ % who received local anesthetic and steroid .


When separated into non-responsive and responsive categories based on initial relief of at least @ weeks with @ procedures , significant improvement ( at least @ % improvement in pain and function ) was seen in @ % in the local anesthetic group and @ % in the local anesthetic with steroid group .


Presumed limitations of this evaluation include the lack of a placebo group .


Transforaminal epidural injections of local anesthetic with or without steroids might be an effective therapy for patients with disc herniation or radiculitis .


The present evidence illustrates the lack of superiority of steroids compared with local anesthetic at @-year follow-up .


Attribution theory claims that people who are stigmatized experience more negative emotional and behavioral reactions from others when they are thought to be responsible for their problems .


Accordingly , this study proposed a neurobiology-based psychoeducational intervention , which attempted to reduce people 's blameworthy attitudes toward and social distance from depressed individuals .


One hundred and thirty-two college students were randomly assigned to an experimental and control group .


Participants in the experimental group received a @-min lecture on neurobiology-based psychoeducation for depressive disorders , and were asked to fill out questionnaires before and @ weeks after the intervention .


The control group , with no intervention , also filled out the same questionnaires before and @ weeks after the experiment .


The main contents of the neurobiology-based psychoeducation concerned the neurotransmission processes and biological mechanisms of depression , in order to emphasize the biological attribution of depression .


An ancova indicated that the neurobiology-based psychoeducational intervention significantly elevated the biological attribution of depression and reduced the social distance from depressed individuals .


Psychological blameworthy attitudes toward depression , however , did not significantly change .


Through a brief psychoeducation program about depression , knowledge of neuroscience could lead to positive benefits .


Public awareness that depression can be effectively prevented and treated may be a way in which people can accept depressed individuals .


Further studies are needed to certify the mechanisms of the effect of neurobiology-based psychoeducation .


After injury , eccentric exercise of the injured limb is often contraindicated .


Cross-education training , whereby the uninvolved limb is exercised , is an alternative that may improve quadriceps muscle strength and activation in the unexercised limb .


To determine the effect of eccentric exercise on quadriceps strength and activation gains in the unexercised limb .


Eighteen healthy individuals were randomly assigned to an eccentric training group or a control group .


Quadriceps strength and activation measures were collected at preintervention , midintervention , and postintervention .


Eccentric training participants exercised their dominant limb with a dynamometer in eccentric mode at @/s , @ times per week for @ weeks .


Quadriceps strength was quantified at @ and @/s in concentric and eccentric modes .


Quadriceps activation was assessed using the burst superimposition technique and quantified via the central activation ratio .


A @ @ repeated-measures analysis of variance was used to detect the effects of group and testing session on quadriceps strength and activation .


Where appropriate , post hoc Bonferroni multiple-comparisons procedures were used .


We found greater eccentric strength in the unexercised limbs of eccentric training participants between preintervention and midintervention and between preintervention and postintervention ( preintervention to midintervention : @/s P = @ ; preintervention to postintervention : @/s P = @ , @/s P = @ ) .


No differences were noted in concentric strength ( P > @ ) .


An overall trend toward greater quadriceps activation in the unexercised knee was detected between preintervention and postintervention ( P = @ ) , with the eccentric training group demonstrating a strong effect ( Cohen d = @ ) .


Control strength did not change ( P > @ ) .


Exercising with eccentric actions resulted in mode-specific and velocity-specific gains in quadriceps strength in the unexercised limb .


A trend toward greater quadriceps activation in the unexercised knee was noted , suggesting that strength gains may have occurred because of enhanced neural activity .


This type of therapy may be a useful addition to rehabilitation programs designed to improve quadriceps strength .


The inhaled corticosteroid fluticasone furoate ( FF ) in combination with the long-acting @-agonist vilanterol ( VI ) is under development for the treatment of asthma and chronic obstructive pulmonary disease .


To compare the efficacy and safety of FF-VI and FF in patients ( @ years old ) with persistent asthma .


In a randomized , double-blind , parallel-group study , patients ( n = @ ) ( intent-to-treat population ) received FF-VI @-@ mcg , FF @ mcg , or placebo once daily ( evening ) by using a dry powder inhaler for @ weeks .


Coprimary end points were change from baseline in trough FEV@ and serial ( @-@ hours ) weighted mean FEV@ ( wmFEV ( @ ) ) .


Rescue-free @-hour periods and safety also were assessed .


Placebo increased trough FEV@ ( @ mL ) and wmFEV ( @ ) ( @ mL ) versus baseline .


Compared with placebo , FF-VI and FF significantly improved trough FEV@ ( @ mL -LSB- P < @ -RSB- and @ mL -LSB- P = @ -RSB- ) , respectively , and serial wmFEV ( @ ) ( @ mL -LSB- P < @ -RSB- and @ mL -LSB- P = @ -RSB- ) , respectively .


Treatment differences between FF-VI and FF approached significance for serial wmFEV ( @ ) ( @ mL ; P = @ ) but not for trough FEV@ ( @ mL ; P = @ ) .


The percentage of rescue-free @-hour periods with FF-VI was @ % greater than FF and @ % greater than placebo .


Statistically significant ( P = @ ) urinary cortisol suppression was observed with FF-VI ( ratio , @ ) relative to placebo , but not with FF .


Adverse event and safety profiles were similar across treatment groups .


Significant improvement in lung function was observed with FF-VI and FF versus placebo in patients with persistent asthma .


Improvement of FEV@ when VI was added to FF was not significant .


The high placebo response in evening trough FEV@ may have influenced the assessment of efficacy .


Although vitamin E and memantine have been shown to have beneficial effects in moderately severe Alzheimer disease ( AD ) , evidence is limited in mild to moderate AD .


To determine if vitamin E ( alpha tocopherol ) , memantine , or both slow progression of mild to moderate AD in patients taking an acetylcholinesterase inhibitor .


Double-blind , placebo-controlled , parallel-group , randomized clinical trial involving @ patients with mild to moderate AD initiated in August @ and concluded in September @ at @ Veterans Affairs medical centers .


Participants received either @ IU/d of alpha tocopherol ( n = @ ) , @ mg/d of memantine ( n = @ ) , the combination ( n = @ ) , or placebo ( n = @ ) .


Alzheimer 's Disease Cooperative Study/Activities of Daily Living ( ADCS-ADL ) Inventory score ( range , @-@ ) .


Secondary outcomes included cognitive , neuropsychiatric , functional , and caregiver measures .


Data from @ participants were analyzed ( alpha tocopherol = @ , memantine = @ , combination = @ , placebo = @ ) , with @ excluded because of a lack of any follow-up data .


Over the mean ( SD ) follow-up of @ ( @ ) years , ADCS-ADL Inventory scores declined by @ units ( @ % CI , @ to @ ; adjusted P = @ ) less in the alpha tocopherol group compared with the placebo group .


In the memantine group , these scores declined @ units less ( @ % CI , -@ to @ ; adjusted P = @ ) than the placebo group 's decline .


This change in the alpha tocopherol group translates into a delay in clinical progression of @ % per year compared with placebo or a delay of approximately @ months over the follow-up period .


Caregiver time increased least in the alpha tocopherol group .


All-cause mortality and safety analyses showed a difference only on the serious adverse event of `` infections or infestations , '' with greater frequencies in the memantine ( @ events in @ participants ) and combination groups ( @ events in @ participants ) compared with placebo ( @ events in @ participants ) .


Among patients with mild to moderate AD , @ IU/d of alpha tocopherol compared with placebo resulted in slower functional decline .


There were no significant differences in the groups receiving memantine alone or memantine plus alpha tocopherol .


These findings suggest benefit of alpha tocopherol in mild to moderate AD by slowing functional decline and decreasing caregiver burden .


Cognitive dysfunction after subarachnoid hemorrhage ( SAH ) has been attributable to presence of subarachnoid blood , hydrocephalus ( HCP ) , cerebral edema , vasospasm , and temporary clipping of intracranial aneurysm .


Provision of neuroprotection during temporary clipping may improve postoperative cognition in such patients .


Good-grade aneurysmal SAH patients undergoing temporary clipping during surgery were allocated either to group C ( control ) or group P ( propofol ) .


Patients in group P received propofol in titrated doses to attain a burst suppression ratio of @ @ % on bispectral index ( BIS ) monitor .


The cognitive function as assessed by Hindi-language modification of mini-mental state examination ( HMSE ) score was evaluated preoperatively , @ h after surgery , and at discharge from hospital .


A score of @ was indicative of cognitive dysfunction .


Perioperative complications , duration of intensive care unit ( ICU ) and hospital stay , and outcome at discharge were noted .


A total of @ patients ( @ and @ in group C and P respectively ) were included in the study .


@ % of the patients had anterior circulation aneurysms .


At @ h after surgery , eight and @ patients in group C and P respectively ; and at discharge , five patients in each group had cognitive dysfunction .


In both groups , the trend showed a decline in cognition at @ h followed by improvement at discharge .


Glasgow outcome score in both the groups was comparable ( P > @ ) .


Intraoperative brain bulge , postoperative vasospasm , and cerebral infarction were found to be independent risk factors for cognitive dysfunction .


Pharmacologic neuroprotection with propofol at the time of temporary clipping during surgery for aneurysmal SAH did not offer any advantage as far as preservation of cognition is concerned .


The purpose of this article is to assess the effect of the adaptive statistical iterative reconstruction ( ASIR ) technique on image quality in hip MDCT arthrography and to evaluate its potential for reducing radiation dose .


Thirty-seven patients examined with hip MDCT arthrography were prospectively randomized into three different protocols : one with a regular dose ( volume CT dose index -LSB- CTDIvol -RSB- , @ mGy ) and two with a reduced dose ( CTDIvol , @ or @ mGy ) .


Images were reconstructed using filtered back projection ( FBP ) and four increasing percentages of ASIR ( @ % , @ % , @ % , and @ % ) .


Image noise and contrast-to-noise ratio ( CNR ) were measured .


Two musculoskeletal radiologists independently evaluated several anatomic structures and image quality parameters using a @-point scale .


They also jointly assessed acetabular labrum tears and articular cartilage lesions .


With decreasing radiation dose level , image noise statistically significantly increased ( p = @ ) and CNR statistically significantly decreased ( p = @ ) .


We also found a statistically significant reduction in noise ( p = @ ) and increase in CNR ( p@ @ ) with increasing percentage of ASIR ; in addition , we noted statistically significant increases in image quality scores for the labrum and cartilage , subchondral bone , overall diagnostic quality ( up to @ % ASIR ) , and subjective noise ( p@ @ ) , and statistically significant reductions for the trabecular bone and muscles ( p@ @ ) .


Regardless of the radiation dose level , there were no statistically significant differences in the detection and characterization of labral tears ( n = @ ; p = @ ) and cartilage lesions ( n = @ ; p@ @ ) depending on the ASIR percentage .


The use of up to @ % ASIR in hip MDCT arthrography helps to reduce radiation dose by approximately @-@ % , while maintaining diagnostic image quality comparable to that of a regular-dose protocol using FBP .


The purpose of this study was to investigate the effects of different cold-water immersion ( CWI ) protocols on the inflammatory response to and functional recovery from high-intensity exercise .


Eight healthy recreationally active males completed five trials of a high-intensity intermittent sprint protocol followed by a randomly assigned recovery condition : @ of @ CWI protocols ( CWI-@ min @ C , CWI-@ min @ C , CWI-@ min @ C , or CWI-@ min @ C ) versus passive rest .


Circulating mediators of the inflammatory response were measured from EDTA plasma taken pre-exercise ( baseline ) , immediately post-exercise , and at @ , @ , and @ h post-exercise .


Ratings of perceived soreness and impairment were noted on a @-pt Likert scale , and squat jump and drop jump were performed at these time points .


IL-@ , IL-@ , and MPO increased significantly from baseline immediately post-exercise in all conditions .


IL-@ remained elevated from baseline at @ h in the CWI-@ min @ C , CWI-@ min @ C , and CWI-@ min @ C conditions , while further increases were observed for IL-@ and MPO in the CWI-@ min @ C and CWI-@ min @ C conditions .


Squat jump and drop jump height were significantly lower in all conditions immediately post-exercise and at @ h. Drop jump remained below baseline at @ and @ h in the CON and CWI-@ min @ C conditions only , while squat jump height returned to baseline in all conditions .


Cold-water immersion appears to facilitate restoration of muscle performance in a stretch-shortening cycle , but not concentric power .


These changes do not appear to be related to inflammatory modulation .


CWI protocols of excessive duration may actually exacerbate the concentration of cytokines in circulation post-exercise ; however , the origin of the circulating cytokines is not necessarily skeletal muscle .


The objective of the study was to determine the relative bioavailability of an extended-release multilayer bead formulation of methylphenidate hydrochloride ( MPH-MLR ) @mg vs. methylphenidate immediate-release ( IR ; Ritalin ( ) ) tablets as single and multiple doses in the fed state .


A single-center , multiple-dose , randomized , open-label , two-period crossover study conducted in @ healthy adults assigned to @days of once-daily MPH-MLR @mg or IR methylphenidate @mg three times daily .


MPH-MLR @mg produced reproducible biphasic profiles of plasma methylphenidate concentrations characterized by a rapid initial peak , followed by a moderate decline reaching a plateau ~ @ h post dose , then a gradual increase culminating in an attenuated second peak ~ @h post dose .


Maximum concentration was lower for MPH-MLR @mg than IR methylphenidate @mg three times daily on day @ ( @ vs. @ ng/mL ) ; exposure was similar .


The geometric mean ratios ( MPH-MLR/IR methylphenidate -LSB- @ % CI -RSB- ) of log-transformed area under the plasma drug concentration-time curve to the last measurable observation ( day @ : @ -LSB- @-@ @ -RSB- ; day @ : @ -LSB- @-@ @ -RSB- ) , and area under the plasma drug concentration extrapolated to infinity ( day @ : @ -LSB- @-@ @ -RSB- ; day @ : @ -LSB- @-@ @ -RSB- ) were within the @-@ % bioequivalence range .


The meanSD MPH-MLR @-mg capsule day @ area under the plasma drug concentration vs. time curve from @ to @h ( @ ngh/mL ) was greater than IR methylphenidate @mg three times daily ( @ ngh/mL ) , confirming steady-state levels during the study period .


All treatment regimens were safe and well tolerated .


MPH-MLR @-mg capsule once daily or IR methylphenidate @mg three times daily provides comparable maximum methylphenidate concentrations and systemic exposure in the fed state .


Racial and gender disparities for smoking cessation might be accounted for by differences in expectancies for tobacco interventions , but few studies have investigated such differences or their relationships with motivation to quit and abstinence self-efficacy .


In this cross-sectional study , @ smokers ( African American : n = @ , @ % ; women : n = @ , @ % ) under criminal justice supervision who enrolled in a clinical smoking cessation trial in which all received bupropion and half received counseling .


All participants completed pretreatment measures of expectancies for different tobacco interventions , motivation to quit , and abstinence self-efficacy .


The indirect effects of race and gender on motivation to quit and abstinence self-efficacy through expectancies for different tobacco interventions were evaluated .


African Americans ' stronger expectancies that behavioral interventions would be effective accounted for their greater motivation to quit and abstinence self-efficacy .


Women 's stronger expectancies for the effectiveness of pharmacotherapy accounted for their greater motivation to quit , whereas their stronger expectancies for the effectiveness of behavioral treatments accounted for their greater abstinence self-efficacy .


Findings point to the mediating role of expectancies for treatment effectiveness and suggest the importance of exploring expectancies among African Americans and women as a way to augment motivation and self-efficacy .


GLP-@ receptor ( GLP-@R ) agonists induce natriuresis and reduce blood pressure ( BP ) through incompletely understood mechanisms .


We examined the effects of acute and @-day administration of liraglutide on plasma atrial natriuretic peptide ( ANP ) , urinary sodium excretion , office and @-h BP , and heart rate ( HR ) .


Liraglutide or placebo was administered for @ weeks to hypertensive subjects with type @ diabetes in a double-blinded , randomized , placebo-controlled crossover clinical trial in the ambulatory setting .


End points included within-subject change from baseline in plasma ANP , Nt-proBNP , office BP , and HR at baseline and over @ h following a single dose of liraglutide ( @ mg ) and after @ days of liraglutide ( titrated to @ mg ) versus placebo administration .


Simultaneous @-h ambulatory BP and HR monitoring and @-h urine collections were measured at baseline and following @ days of treatment .


Plasma ANP levels did not change significantly after acute ( +@ pg/mL , P = @ , @ % CI -LSB- -@ , +@ -RSB- at @ h ) or chronic ( -@ pg/mL , @ % CI -LSB- -@ , +@ -RSB- at @ h ) liraglutide administration .


Liraglutide significantly increased @-h and nighttime urinary sodium excretion ; however , @-h systolic BP was not significantly different .


Small but significant increases in @-h and nighttime diastolic BP and HR were observed with liraglutide .


Body weight , HbA@c , and cholesterol were lower , and office-measured HR was transiently increased ( for up to @ h ) with liraglutide administration .


Sustained liraglutide administration for @ weeks increases urinary sodium excretion independent of changes in ANP or BP in overweight and obese hypertensive patients with type @ diabetes .


To determine the ability of sheep to mobilise their body reserves after being deprived of feed prior to transport for slaughter .


A total of @ @ - and @-year-old cull ewes were held off pasture for @ , @ , @ or @ hours ( n = @ per group ) then transported @ hour by road , unloaded and washed , held in lairage for @ hours then slaughtered .


Blood samples were collected from a subsample of @ unfasted ewes @ week earlier , and from all ewes at exsanguination to determine concentrations of serum metabolites indicative of adaptation to fasting .


In addition , several attributes of carcass quality were measured .


At slaughter , increased time off pasture prior to transport resulted in no change in glucose concentrations in serum ( p = @ ) .


There were differences ( p < @ ) between the group fasted for @ compared with @ hours in mean concentrations of free fatty acids ( @ ( SD @ ) vs. @ ( SD @ ) mmol/L ) , - hydroxybutyrate ( @ ( SD @ ) vs. @ ( SD @ ) mmol/L ) , triglycerides ( @ ( min @ , max @ ) vs. @ ( min @ , max @ ) mmol/L ) and urea ( @ ( SD @ ) vs. @ ( SD @ ) mmol/L ) .


Different periods of feed deprivation had no effect ( p > @ ) on carcass weights ( mean @ , min @ , max @ kg ) or dressing out percentages ( mean @ , min @ , max @ % ) .


Meat ultimate pH was unaffected ( p > @ ) by the period of feed deprivation but meat became darker ( p < @ ) and had reduced redness ( p < @ ) with increasing time off feed .


The results suggest that sheep in variable body condition adapted to the periods of feed deprivation by mobilising their energy reserves without any evidence of metabolic depletion ( e.g. depleted blood glucose or high meat pH ) .


However , being deprived of feed they probably experience a degree of hunger .


Spectacle independence is becoming increasingly important in cataract surgery .


Not correcting corneal astigmatism at the time of cataract surgery will fail to achieve spectacle independency in @ % to @ % of patients .


To compare bilateral aspherical toric with bilateral aspherical control intraocular lens ( IOL ) implantation in patients with cataract and corneal astigmatism .


A multicenter , hospital-based , randomized clinical trial was conducted .


The participants included @ individuals with bilateral cataract and bilateral corneal astigmatism of at least @ diopters ( D ) who were randomized to receive either bilateral toric ( n = @ ) or bilateral control ( n = @ ) IOL implantation .


Bilateral implantation of an aspherical toric IOL or an aspherical control IOL .


Spectacle independency for distance vision , uncorrected distance visual acuity , refractive astigmatism , contrast sensitivity , wavefront aberrations , and refractive error-related quality-of-life questionnaire .


Preoperatively , mean ( SD ) corneal astigmatism was @ ( @ ) D and @ ( @ ) D in the toric and control groups , respectively .


Four patients ( @ % ) were lost to follow-up .


At @ months postoperatively , @ ( @ % ) of the patients in the toric group achieved an uncorrected distance visual acuity of @/@ or better compared with @ ( @ % ) in the control group ( P < @ ; odds ratio , @ ; @ % CI , @-@ @ ) .


Spectacle independency for distance vision was achieved in @ patients ( @ % ) in the toric group compared with @ patients ( @ % ) in the control group ( P < @ ; odds ratio , @ ; @ % CI , @ - @ ) .


Mean refractive astigmatism was -@ ( @ ) D and -@ D ( @ ) D , respectively .


Vector analysis of toric IOLs showed a mean magnitude of error of +@ D , indicative of overcorrection .


No significant differences were found in contrast sensitivity , higher-order aberrations , or refractive error-related quality of life .


In patients with cataract and corneal astigmatism , bilateral toric IOL implantation results in a higher spectacle independency for distance vision compared with bilateral control IOL implantation .


No significant differences were identified in contrast sensitivity , higher-order aberrations , or refractive error-related quality of life following both treatments .


This study 's purpose was to evaluate the success of calcium hydroxide ( CH ) and mineral trioxide aggregate ( MTA ) pulpotomies following the use of five percent sodium hypochlorite ( NaOCl ) as an antibacterial agent to clean the chamber prior to application of the pulpotomy agent .


A total of @ teeth were randomly divided into two pulpotomy groups ( CH or MTA ) .


The teeth in each pulpotomy group , CH and MTA , were further randomly divided into subgroups to receive either the NaOCl ( experimental ) or saline ( control ) cleaning agent prior to applying the pulpotomy agent .


The treatments were followed clinically and radiographically for @ months .


The radiographic success rates were @ percent for CH NaOCl , @ percent for CH saline control , @ percent for MTA NaOCl , and @ percent for MTA saline control .


There were no significant differences between the radiographic success rates in the CH and MTA subgroups ( CH NaOCl-CH control and MTA NaOCl-MTA control ) ; no significant differences were observed when comparing the CH NaOCl-MTA NaOCl groups and the CH NaOCl-MTA control groups .


Use of sodium hypochlorite as an antibacterial agent prior to application of the pulpotomy agent improved the success of calcium hydroxide pulpotomies to equal the success of mineral trioxide aggregate pulpotomies for observation up to @ months .


A treatment strategy to inhibit nonsteroidal anti-inflammatory drug ( NSAID ) - induced small intestinal lesions has not yet been established .


To clarify whether monotherapy with a gastromucoprotective drug , geranylgeranylacetone ( GGA ) , inhibits NSAID-induced acute mucosal injury of the upper digestive tract and small intestine .


A prospective , randomized , comparative study .


All procedures were performed at Osaka Medical College .


The subjects , thirty healthy adult volunteers , were randomly divided into two groups .


In the NSAID-GGA group , @ mg/day of diclofenac sodium and @ mg/day of GGA were orally administered for two weeks .


In the NSAID-FAM group , @ mg/day of diclofenac sodium and @ mg/day of famotidine ( FAM ) were orally administered for two weeks .


esophagogastroduodenoscopy ( EGD ) and video capsule endoscopy ( VCE ) were performed before and two weeks after drug administration .


In addition , we measured fecal occult blood reactions and the fecal calprotectin levels .


No significant differences were observed between the groups in the mean increase in esophageal/gastroduodenal lesions .


The mean increases in the scores in the NSAID-FAM group ( NSAID-GGA group ) of small bowel lesions were as follows : erythema : @ @ ( @ @ ) , erosions : @ @ ( @ @ ) , ulcers : @ @ ( @ @ ) and edema : @ @ ( @ @ ) .


The scores for erythema and ulcers were significantly lower in the NSAID-GGA group than in the NSAID-FAM group ( p = @ and @ , respectively ) .


We compared the prophylactic effects of a mucoprotective drug , GGA , and an H@RA , famotidine , on mucosal injury involving the esophagus to the small intestine related to the two-week oral administration of diclofenac sodium in healthy volunteers .


In the upper digestive tract , the prophylactic effects were similar between the two drugs .


However , in the small intestine , GGA more markedly inhibited the development of lesions compared to famotidine .


A small number of studies conducted to date have suggested that transcranial direct current stimulation ( tDCS ) applied to the temporoparietal cortex may reduce auditory hallucinations in patients with schizophrenia .


Prefrontal brain stimulation with other methods , has also been shown to potentially improve the negative symptoms of this disorder .


To investigate the therapeutic potential of daily bimodal tDCS : anodal stimulation to the prefrontal cortex and cathodal stimulation to the temporoparietal junction in patients with persistent hallucinations and negative symptoms of schizophrenia .


We conducted two small randomized double-blind controlled trials comparing bimodal tDCS to sham stimulation .


In one study , stimulation was provided unilaterally , in the second study it was provided bilaterally .


Neither unilateral nor bilateral tDCS resulted in a substantial change in either hallucinations or negative symptoms .


Stimulation was well tolerated without side-effects .


Daily tDCS does not appear to have substantial potential in the treatment of hallucinations or negative symptoms and further research should investigate higher doses of stimulation or more frequently applied treatment schedules .


An emergency department ( ED ) visit may be an effective place to screen and educate families about injury prevention .


The purpose of this study was to determine if a computerized kiosk in a pediatric ED can screen families for injury risk and encourage them to make more safety changes at follow-up survey compared with an injury prevention specialist ( IPS ) .


A prospective , randomized controlled study was performed with families of children younger than @ years in an ED lobby .


Families were screened for injury risk by computerized kiosk based on child 's age category at triage ( birth to @ year , @-@ years , @-@ years , or @-@ years ) .


Families were randomized to receive either injury behavior instructions by kiosk printout or by IPS when answers to specific practices were deemed unsafe .


Three weeks after intervention , families were telephoned to determine change in safety practices .


Three hundred seventeen families completed ED kiosk screen at enrollment ( @ kiosk , @ IPS ) .


On initial screen , kiosk families practiced @ % of behaviors safely versus @ % in the IPS group ( p = @ ) .


A total of @ families ( @ % ) were reached for follow-up ( @ kiosk , @ IPS ) .


On average , IPS families improved their safe behavior responses by @ % versus @ % in the kiosk group ( p < @ ) .


Significantly more families in the IPS group than in the kiosk group ( @ % vs. @ % , p < @ ) used additional safety equipment after the intervention .


A computerized kiosk based in a pediatric ED can help screen families for their injury risk .


However , to elicit significant behavior change , an IPS discussing safety changes may be more effective .


To compare the efficacy of postoperative topical nepafenac ( @ % ) with prednisolone acetate ( @ % ) as anti-inflammatory agents in eyes undergoing Transscleral Sutureless Vitrectomy ( TSV ) .


Prospective , double-blind , randomized , single center clinical study .


Eighty eyes of @ subjects , who underwent small gauge vitrectomy , were included in the study .


The subjects who fulfilled the inclusion criteria were randomized to either topical nepafenac only ( Group @ ) or prednisolone acetate only ( Group @ ) , to be used as postoperative anti-inflammatory agents .


The subjects were reviewed on days @ , @ , and @ .


Ocular and adnexal inflammation was appropriately graded using the standardized classification .


Grading of ocular pain was done on the Visual Analog Scale ( VAS ) .


The Wilcoxon rank-sum test , using two-sided analysis , was used .


During the follow-up , both Group @ and Group @ did not have a significant difference related to the grade of the anterior chamber inflammation ( P > @ ) or adnexal inflammation ( P > @ ) .


Pain perception was less in the subjects in Group @ as compared to subjects in Group @ , but was not statistically significant ( P > @ ) .


Postoperative topical nepafenac was non-inferior to prednisolone acetate in reducing postoperative ocular inflammation in eyes undergoing TSV .


Environmental enteropathy ( EE ) is a subclinical condition among children in the developing world , characterized by T-cell infiltration of the small-bowel mucosa and diffuse villous atrophy .


EE leads to macronutrient and micronutrient malabsorption and stunting , with a resultant increased risk for infection and reduced cognitive development .


We tested the hypothesis that zinc and albendazole treatments would reduce the severity of EE in rural African children .


In a randomized , double-blind , placebo-controlled trial in rural southern Malawi , asymptomatic children , @ to @ years old and at high risk for EE , received either a single dose of albendazole , a @-day course of @ mg zinc sulfate , or a placebo .


Subjects were given the dual-sugar absorption test , and the ratio of lactulose to mannitol ( L : M ) in urine was used to determine the severity of EE at baseline and @ days after completion of the assigned regimen .


The primary outcome was the change in the L : M.


A complete set of urine samples was obtained from @ of @ children enrolled and analyzed .


The mean baseline L : M was @ @ among all children and did not differ among groups ( normal L : M range , < @ ) .


At the end of the study , the L : M ratio had increased more in the placebo group ( @ @ ) than in the zinc group ( @ @ ; P < @ ) or the albendazole group ( @ @ ; P < @ ) .


Treatment with zinc or albendazole protects against a significant increase in the L : M ratio , a biomarker for EE , in asymptomatic rural Malawian children .


These findings could provide insight into the etiology and pathogenesis of EE .


Clinicaltrials.gov Number : NCT@ .


Cancer-related malnutrition is multifactorial and related to a bad prognosis .


The aim of this study was to investigate the effect of intensive , individual dietary counseling of patients in radiotherapy and/or chemotherapy for gynecologic - , gastric - , or esophageal cancer .


@ outpatients were stratified by diagnoses and randomly assigned to one of two groups ( G@ ; n = @ and G@ ; n = @ ) .


The basic regimen , applied to both groups , included measurement of body weight , @-h dietary recall interview , micronutrient status and quality of life .


In addition G@ received intensive , individual dietary counseling one hour per week and , if the patient accepted , a daily oral nutritional supplement containing @ kJ , @ g protein and @ g EPA .


At the end of the treatment period , significantly fewer patients had lost weight in the intervention group ( mean : @ % vs. @ % , p < @ ) , and the fulfillment of estimated energy requirements was better during treatment ( mean : @ % vs. @ % , p < @ ) .


A significant positive effect was observed on the fulfillment of protein requirement , both during the treatment period ( mean : @ % vs. @ % , p < @ ) and at follow-up ( mean : @ % vs. @ % , p < @ ) .


In these cancer patients , intensive , individual dietary counseling was associated with a better weight maintenance and a higher provision of adequate amounts of protein and energy .


The intervention had no significant effects on patients ' quality of life , incidence of treatment-related side effects or appearance of micronutrient deficiencies .


Chronic inflammation is hypothesized to influence prostate cancer development , although a definitive link has not been established .


Prostate cancer cases ( N = @ ) detected on a for-cause ( clinically indicated ) or end-of-study ( protocol directed ) biopsy , and frequency-matched controls ( N = @ ) , defined as negative for cancer on an end-of-study biopsy , were sampled from the placebo arm of the Prostate Cancer Prevention Trial .


Inflammation prevalence and extent in benign areas of biopsy cores were visually assessed using digital images of hematoxylin and eosin-stained sections .


Logistic regression was used to estimate associations .


Of note , @ % of cases and @ % of controls had at least one biopsy core ( of three assessed ) with inflammation in benign areas , most of which was chronic .


Men who had at least one biopsy core with inflammation had @ -LSB- @ % confidence interval ( CI ) , @-@ @ -RSB- times the odds of prostate cancer compared with men who had zero cores with inflammation .


The association was stronger for high-grade disease ( Gleason sum @-@ , N = @ ; OR , @ ; @ % CI , @-@ @ ) .


These patterns were present when restricting to cases and controls in whom intraprostatic inflammation was the least likely to have influenced biopsy recommendation because their prostate-specific antigen ( PSA ) was low ( < @ ng/mL at biopsy ) .


Inflammation , most of which was chronic , was common in benign prostate tissue , and was positively associated with prostate cancer , especially high grade .


The association did not seem to be due to detection bias .


This study supports an etiologic link between inflammation and prostate carcinogenesis , and suggests an avenue for prevention by mitigating intraprostatic inflammation .


The aims of this study were to establish a bioanalytical method and to evaluate the bioequivalence of two drug products ; a generic sildenafil @ mg film-coated vs. the brand drug Viagra @ mg film-coated tablets .


Bioequivalence of tablets was tested by comparisons against the reference brand product in accordance with the requirements of the Declaration of Helsinki , the current Good Clinical Practice ( GCP ) Guidelines and the International Conference Harmonization ( ICH ) .


The relationship between concentration and peak area ratio was found to be linear within the range of @ - @ ng/mL for sildenafil .


The correlation coefficient ( r ) was always greater than @ during the course of the validation Statistical comparison of the main pharmacokinetic parameters showed no significant difference between test and reference .


The @ % CIs of geometric mean ratios ( test to reference ratios ) were @ % , @ % , and @ % for AUC ( @-last ) , AUC ( @ - ) , and C ( max ) , respectively .


These pharmacokinetic parameter values lie within the FDA and European Medicines Agency specified bioequivalence limit ( @ - @ % ) .


Both formulations were well tolerated by all subjects and they were discharged in good health .


The tested drug product was bioequivalent to the reference drug and had the same safety profile .


Functional neuroimaging studies implicate anterior cingulate and limbic dysfunction in major depressive disorder ( MDD ) and responsiveness to antidepressants .


Diffusion tensor imaging ( DTI ) enables characterisation of white matter tracts that relate to these regions .


To examine whether DTI measures of anterior cingulate and limbic white matter are useful prognostic biomarkers for MDD .


Of the @ MDD out-patients from the International Study to Predict Optimized Treatment for Depression ( iSPOT-D ) who provided baseline magnetic resonance imaging ( MRI ) data , @ completed an @-week course of antidepressant medication ( randomised to escitalopram , sertraline or extended-release venlafaxine ) and were included in the present analyses .


Thirty-four matched controls also provided DTI data .


Fractional anisotropy was measured for five anterior cingulate-limbic white matter tracts : cingulum cingulate and hippocampus bundle , fornix , stria terminalis and uncinate fasciculus .


( Trial registered at ClinicalTrials.gov : NCT@ . )


A cross-validated logistic regression model demonstrated that altered connectivity for the cingulum part of the cingulate and stria terminalis tracts significantly predicted remission independent of demographic and clinical measures with @ % accuracy .


Prediction improved to @ % when age was added to this model .


Anterior cingulate-limbic white matter is a useful predictor of antidepressant treatment outcome in MDD .


Type @ diabetes is known to be associated with increasing cardiovascular mortality .


Malondialdehyde-modified LDL ( MDA-LDL ) is an oxidized LDL and is increased in patients with diabetes or hypertriglyceridemia .


Elevated MDA-LDL has been reported to be a risk factor of atherosclerosis or cardiovascular disease .


Sitagliptin is a dipeptidyl peptidase-@ inhibitor and a new class of hypoglycemic agents .


In this study , the effects of increasing the dose of metformin and add-on sitagliptin on MDA-LDL were examined in type @ diabetes patients .


Seventy patients with type @ diabetes , inadequately controlled despite on-going treatment with metformin @ mg/day , were enrolled in this randomized controlled trial .


The patients received additional metformin ( @ mg/day ) or sitagliptin ( @ mg/day ) for @ months , and changes in metabolic parameters including MDA-LDL were evaluated .


After @ months of treatment , add-on sitagliptin ( n = @ ) improved fasting blood glucose ( FBG ) and hemoglobin A@c ( HbA@c ) to significantly greater extent than increasing the dose of metformin ( n = @ ) .


There were no differences in total cholesterol and low-density lipoprotein cholesterol levels between two groups .


MDA-LDL levels ( mean S.E. ) decreased significantly with increasing the dose of metformin ( from @ @ to @ @ U/L , P < @ ) , but remained unchanged with add-on sitagliptin treatment ( from @ @ to @ @ U/L , p > @ ) .


Multiple linear regression analysis identified increasing the dose of metformin treatment as the only independent factor associated with decreased MDA-LDL ( coefficient @ , P < @ ) , and no significant correlation between change in MDA-LDL and fasting blood glucose or HbA@c .


These results suggest that increasing the dose of metformin improves serum MDA-LDL levels in type @ diabetes mellitus .


This study was designed to test the effect of the featured/featureless nature of deviant stimuli on mismatch negativity ( MMN ) , P@ ( P@a and P@b ) and on behavioral discrimination performances .


Ten healthy adults were submitted to stimuli contrasted by the presence or absence of a frequency sweep .


Discrimination performances were collected during the neurophysiological sessions .


MMN , P@a and P@b were much larger for featured deviants than for featureless ones .


Behavioral data ( d' , at ceiling level , and reaction times ) were not affected by the featured/featureless nature of the deviant stimulus .


Behavioral results and MMN amplitudes are in accordance with our previous study , using the same design albeit in an ignore condition and with collection of the behavioral data deferred until after the neurophysiological sessions .


The present study strengthens previous evidence suggesting that two mechanisms contribute to the MMN evoked by featured deviants : the memory comparison process and the adaptation/fresh-afferent phenomenons .


We here demonstrate that the neurophysiological processes underlying P@ generation are also impacted by the featured/featureless nature of the deviant stimulus and that the dissociation from behavioral data , which are not impacted , is also observed when both types of data are recorded simultaneously .


To evaluate the effect of an innovative model integrating telemonitoring of vital parameters and telephone support on @-month survival and hospital admissions of elderly adults with heart failure ( HF ) .


Parallel-arm , randomized trial .


Geriatric acute care ward and outpatient clinic at Policlinico Campus Biomedico ( Rome , Italy ) .


Individuals with HF aged @ and older ( mean age @ ) randomly assigned to intervention ( n = @ ) or control ( n = @ ) .


Participants had an average ejection fraction of @ % .


Telemonitoring system ( receives and communicates oxygen saturation , heart rate , and blood pressure readings ) and office-hours telephonic support provided by a geriatrician .


Combination of all-cause death and hospital admissions .


The two groups were similar with the exception of the prevalence of women and of disability ( both more common in the control group ) .


Three patients for each group were lost to follow-up ( final analyzed sample size : @ ) .


Incidence of the main outcome was @ % in the control group and @ % in the intervention group ( relative risk = @ , @ % confidence interval ( CI ) = @-@ @ ) .


The results were unchanged after taking into account the setting of enrollment , sex , and disability ( hazard ratio = @ , @ % CI = @-@ @ ) .


Telemonitoring of elderly people with HF is feasible and reduces the risk of death and hospitalization .


Further studies are needed to confirm these findings and evaluate the cost-efficacy of the service .


Postoperative delirium in the intensive care unit ( ICU ) is a frequent complication after cardiac or thoracic surgery and is associated with increased morbidity and mortality .


In this single-center substudy of the BAG-RECALL trial ( NCT@ ) , we screened patients after cardiac or thoracic surgery in the ICU twice daily for delirium using the Confusion Assessment Method for the ICU .


The primary outcome was the incidence of delirium in patients who had been randomized to intraoperative Bispectral Index ( BIS ) - guided and end-tidal anesthetic concentration-guided depth of anesthesia protocols .


As a secondary analysis , a Bayesian stochastic search variable selection strategy was used to rank a field of candidate risk factors for delirium , followed by binary logistic regression .


Of @ patients assessed , @ of @ ( @ % ) in the BIS group and @ of @ ( @ % ) in the end-tidal anesthetic concentration group developed postoperative delirium in the ICU ( odds ratio @ , @ % confidence interval , @-@ @ , P = @ ) .


Low average volatile anesthetic dose , intraoperative transfusion , ASA physical status , and European System for Cardiac Operative Risk Evaluation were identified as independent predictors of delirium .


A larger randomized study should determine whether brain monitoring with BIS or an alternative method decreases delirium after cardiac or thoracic surgery .


The association between low anesthetic concentration and delirium is a surprising finding and could reflect that patients with poor health are both more sensitive to the effects of volatile anesthetic drugs and are also more likely to develop postoperative delirium .


Investigation of candidate methods to prevent delirium should be prioritized in view of the established association between postoperative delirium and adverse patient outcomes .


Angiogenesis contributes to the progression of urothelial carcinoma ( UC ) .


In the current study , the authors investigated the role of maintenance sunitinib in patients with advanced UC .


Patients with locally recurrent/metastatic UC and adequate organ function who achieved stable disease or a partial or complete response after @ to @ chemotherapy cycles were randomized to sunitinib at a dose of @ mg/day ( @ days on and @ days off ) or placebo .


The primary endpoint was the @-month progression rate .


Secondary endpoints were safety , survival , change in serum vascular endothelial growth factor ( VEGF ) / soluble VEGF receptor-@ ( sVEGFR@ ) , and the activity of sunitinib in patients who developed disease progression while receiving placebo .


A total of @ eligible patients per treatment arm were required to select better therapy with @ % probability ( = @ ) .


A total of @ eligible patients were randomized to either the sunitinib arm ( @ patients ) or the placebo arm ( @ patients ) .


The median number of cycles received was @ cycles per treatment arm .


The most common grade @ to @ adverse events ( graded according to version @ of the National Cancer Institute Common Terminology Criteria for Adverse Events ) among patients receiving sunitinib were thrombocytopenia , diarrhea , mucositis , fatigue , and hypertension .


There were no grade @ or @ adverse events noted among > @ % of patients receiving placebo .


The @-month progression rate was @ % versus @ % .


The median progression-free survival ( PFS ) was @ months ( range , @ months-@ @ months ) versus @ months ( range , @ months -@ months ) for the sunitinib versus placebo arms , respectively .


Patients receiving placebo were found to have no changes in their serum VEGF/sVEGFR@ levels over time .


Patients treated with sunitinib had no significant change in their VEGF level , but the sVEGFR@ level significantly decreased after cycles @ and @ ( P < @ ) and at the time of disease progression ( P = @ ) .


A baseline VEGF level that was at or greater than the median was found to be correlated with a longer PFS .


Sixteen patients who were receiving placebo received sunitinib at the time of disease progression , with the best responses being @ partial response ( @ % ) , @ cases of stable disease ( @ % ) , and @ cases of progressive disease ( @ % ) ; @ patients were not evaluable for response .


The median PFS was @ months ( range , @ months-@ months ) .


The current multicenter study was limited by premature closure and a small sample size .


Maintenance sunitinib did not appear to improve the @-month progression rate .


Open-label sunitinib was found to have only modest activity .


The sVEGFR@ level decreased among patients receiving sunitinib .


Families with low incomes experience an array of health and social challenges that compromise their resilience and lead to negative family outcomes .


Along with financial constraints , there are barriers associated with mental and physical health , poorer education and language .


In addition , vulnerable populations experience many services as markedly unhelpful .


This combination of family and service barriers results in reduced opportunities for effective , primary-level services and an increased use of more expensive secondary-level services ( e.g. , emergency room visits , child apprehensions , police involvement ) .


A systematic review of effective interventions demonstrated that promotion of physical and mental health using existing service was critically important .


The Families First Edmonton Trial ( FFE ) tests four service integration approaches to increase use of available health and social services for families with low-income .


It is a randomized , two-factor , single-blind , longitudinal effectiveness trial where low-income families ( @ ) were randomly assigned to receive either ( @ ) Family Healthy Lifestyle plus Family Recreation service integration ( Comprehensive ) , ( @ ) Family Healthy Lifestyle service integration , ( @ ) Family Recreation service integration , or ( @ ) existing services .


To be eligible families needed to be receiving one of five government income assistance programs .


The trial was conducted in the City of Edmonton between January @ and August @ .


The families were followed for a total of three years of which interventional services were received for between @ and @ months .


The primary outcome is the number of family linkages to health and social services as measured by a customized survey tool `` Family Services Inventory '' .


Secondary outcomes include type and satisfaction with services , cost of services , family member health , and family functioning .


Where possible , the measures for secondary outcomes were selected because of their standardization , the presence of published norming data , and their utility as comparators to other studies of low-income families .


As an effectiveness trial , community and government partners participated in all committees through a mutually agreed upon governance model and helped manage and problem solve with researchers .


Modifications were made to the FFE trial based on the pragmatics of community-based trials .


To determine the treatment outcome of combined androgen blockade ( CAB ) therapy using the non-steroidal antiandrogen bicalutamide or the steroidal antiandrogen chlormadinone in patients with prostate cancer .


In total , @ patients with prostate cancer enrolled in the present study were randomized to receive CAB therapy using a gonadotropin-releasing hormone ( GnRH ) agonist , combined with bicalutamide or chlormadinone .


The survival of patients was analyzed .


The @-year cancer-specific survival for the bicalutamide - and chlormadinone-treated groups were @ % and @ % , respectively , with no significant difference ( p = @ ) .


Five-year overall survival was significantly ( p = @ ) better in the bicalutamide-treated group .


Moreover , M@ patients in the chlormadinone group had significantly lower cancer-specific and overall survival compared to those in the bicalutamide-treated group .


However , in the case of M@ patients , no significant difference in cancer-specific nor in overall survival was observed .


CAB therapy using chlormadinone led to a significantly poorer survival outcome versus the use of bicalutamide .


However , because this survival trend was not observed in M@ cases , chlormadinone may still be an option for CAB therapy , depending on clinical stage and the severity of adverse effects , such as hot flashes .


Iodine deficiency is one of the most important causes of congenital hypothyroidism .


In addition to thyroid hormone replacement , iodine supplementation is also given to newborns with congenital hypothyroidism due to iodine deficiency .


We aimed to determine whether it is beneficial to administer iodine supplementation in addition to the L-thyroxine ( L-T@ ) treatment of newborns with congenital hypothyroidism due to iodine deficiency .


Of @ newborns , @ who were diagnosed with congenital hypothyroidism due to iodine deficiency were treated with L-T@ .


The remaining @ cases were given L-T@ plus @ g/day of oral iodine .


Free triiodothyronine ( fT@ ) , free thyroxine ( fT@ ) , thyroid-stimulating hormone ( TSH ) , thyroglobulin ( TG ) , thyroid volume , urine iodine and breast milk iodine levels were measured in the first and third months of treatment , and the data were compared between the two groups .


First - and third-month values of fT@ , fT@ , TSH , TG and thyroid volume for both groups were statistically similar .


There was no significant difference between the two groups in respect to falling levels of fT@ and TSH , the rate of increase of fT@ levels or the shrinkage rate of thyroid volume .


In this study , the addition of oral iodine to L-T@ treatment provided no benefit compared to treatment with L-T@ alone .


Cannabis users often claim that cannabis has the potential to enhance their creativity .


Research suggests that aspects of creative performance might be improved when intoxicated with cannabis ; however , the evidence is not conclusive .


The aim of this study was to investigate the acute effects of cannabis on creativity .


We examined the effects of administering a low ( @ mg delta-@-tetrahydrocannabinol -LSB- THC -RSB- ) or high ( @ mg THC ) dose of vaporized cannabis vs. placebo on creativity tasks tapping into divergent ( Alternate Uses Task ) and convergent ( Remote Associates Task ) thinking , in a population of regular cannabis users .


The study used a randomized , double-blind , between-groups design .


Participants in the high-dose group ( n = @ ) displayed significantly worse performance on the divergent thinking task , compared to individuals in both the low-dose ( n = @ ) and placebo ( n = @ ) groups .


The findings suggest that cannabis with low potency does not have any impact on creativity , while highly potent cannabis actually impairs divergent thinking .


Currently , there is a debate whether the laparoscopic gastric imbrication ( LGI ) offers similar weight loss when compared to the laparoscopic sleeve gastrectomy ( LSG ) .


On the surface , they seem to offer similar-sized stomachs after the procedures are performed .


We chose to perform a randomized double-blinded trial to see if similar-sized pouches result in similar types of weight loss .


Our belief was that sleeve gastrectomy would offer at least a @ % better weight loss over a @-year period .


Thirty patients were randomized to one of two arms .


The patients and the third party administrator following the patients were blinded as to which procedure was chosen .


The surgeon had full knowledge of the patients ' surgery throughout the treatment .


The decision of which arm to place them was made by a single employee of the third party administrator and not shared with the employees following the patients .


Patients were then followed for @ years .


There were no differences in weight , age , or BMI preoperatively .


There were no differences between the two groups at any follow-up time point from @ months to @ years .


Follow-up was @ % .


Due to the large standard deviations present in both groups , there was no statistical difference between either of the groups in terms of weight loss .


The objective of the study was to examine post hoc associations between plasma sphingolipids and lipoprotein kinetics in men with the metabolic syndrome after rosuvastatin treatment .


Plasma sphingolipid profiling , determined by tandem mass spectrometry , was performed in a randomized , double-blind , triple-crossover trial ( n = @ ) of @-week treatment periods with placebo or rosuvastatin ( @ or @ mg/d ) with @-week washouts between treatments .


Baseline plasma ceramides were associated with very low-density lipoprotein ( VLDL ) apolipoprotein ( apo ) - B-@ concentration ( r = @ , P < @ ) and inversely with VLDL apoB-@ fractional catabolic rate ( FCR ; r = -@ , P = @ ) .


Posttreatment changes with rosuvastatin ( @ mg/d ) in plasma ceramides were inversely associated with VLDL apoB-@ FCR ( r = -@ , P = @ ) independent of changes in plasma triglycerides , cholesterol , and low-density lipoprotein-cholesterol .


By contrast , baseline and postrosuvastatin treatment plasma sphingomyelin levels were not associated with apoB-@ kinetics .


Plasma ceramides and sphingomyelin were not associated with the kinetics or concentrations of high-density lipoprotein apoA-I , and low-density lipoprotein apoB .


In the metabolic syndrome , the ability of rosuvastatin to increase VLDL apoB-@ FCR may reflect ceramide-specific mechanistic actions and/or sphingolipid exchange .


Laser hair removal has become an increasingly popular method to remove unwanted or excessive hair .


We have assessed the relative efficacy and discomfort associated with competing hair removal techniques , namely a high average power @nm diode laser using an in-motion technique with a market-leading @nm device with a single-pass vacuum-assisted technique .


This study has determined the long-term ( @-@ months ) hair reduction efficacy and the relative pain induction intensities of these devices .


Prospective , randomized , side-by-side comparison of either the legs or axillae was performed comparing the Soprano XL @nm diode in super hair removal ( SHR ) mode ( Alma Lasers , Buffalo Grove , IL ) hereafter known as the in-motion device vs. the LightSheer Duet @nm diode laser ( Lumenis ) hereafter known as the single pass device .


Five laser treatments were performed @ to @ weeks apart with @ , @ , and @ months follow-ups for hair counts .


Pain was assessed in a subjective manner by the patients on a @-point grading scale .


Hair count analysis was performed in a blinded fashion .


There was a @ % ( SD @ % ) and @ % ( SD @ % ) reduction in hair counts at @ months for the single pass and in-motion devices respectively ( P = @ ) .


The average pain rating for the single pass treatment ( mean @ , @ % CI : @ to @ ) was significantly ( P = @ ) greater than the in-motion treatment ( mean @ , @ % CI @ to @ ) .


This data supports the hypothesis that using diode lasers at low fluences and high average power with a multiple pass in-motion technique is an effective method for hair removal , with less pain and discomfort , while maintaining good efficacy .


The @ month results were maintained at @ month for both devices .


Mindfulness-based cancer recovery ( MBCR ) and supportive-expressive therapy ( SET ) are well-validated psycho-oncological interventions , and we have previously reported health benefits of both programs .


However , little is known about patients ' characteristics or program preferences that may influence outcomes .


Therefore , this study examined moderators of the effects of MBCR and SET on psychological well-being among breast cancer survivors .


A multi-site randomized controlled trial was conducted between @ and @ in two Canadian cities ( Calgary and Vancouver ) .


A total of @ distressed stage I-III breast cancer survivors were randomized into MBCR , SET or a @-day stress management seminar ( SMS ) .


Baseline measures of moderator variables included program preference , personality traits , emotional suppression , and repressive coping .


Outcome measures of mood , stress symptoms , quality of life , spiritual well-being , post-traumatic growth , social support , and salivary cortisol were measured pre - and post intervention .


Hierarchical regression analyses were used to assess moderator effects on outcomes .


The most preferred program was MBCR ( @ % ) .


Those who were randomized to their preference improved more over time on quality of life and spiritual well-being post-intervention regardless of the actual intervention type received .


Women with greater psychological morbidity at baseline showed greater improvement in stress symptoms and quality of life if they received their preferred versus nonpreferred program .


Patients ' program preference and baseline psychological functioning , rather than personality , were predictive of program benefits .


These results suggest incorporating program preference can maximize the efficacy of integrative oncology interventions , and emphasize the methodological importance of assessing and accommodating for preferences when conducting mind-body clinical trials .


To examine the effect of an oral prenatal probiotic on group B Streptococcus ( GBS ) colonization and to demonstrate the feasibility of a larger randomized controlled trial .


This pilot study was an open-label , two-group quasi-experiment .


An urban central city nurse-midwifery and wellness center serving a diverse population .


Ten pregnant participants received the oral probiotic ( Florajen@ ) taken once daily , and @ participants served as controls .


A questionnaire on dietary practices , vaginal cleansing , sexual history , and symptoms and GBS colony count samples were taken at @ - , @ - , and @-weeks gestation .


Participants in the probiotic group reported no adverse events or minor side effects ; one half reported improved gastrointestinal symptoms .


Although two women in each group had positive qualitative prenatal GBS cultures at @ weeks , the probiotic group participants had lower quantitative GBS colony counts .


The eight GBS negative averaged @ % probiotic adherence compared with two GBS positive women who averaged @ % .


Yogurt ingestion was inversely related ( p = @ ) to GBS colonization .


Prenatal probiotic therapy has the potential to reduce GBS colonization .


The potential of the probiotic intervention appears to be linked to daily adherence .


A controlled clinical trial with a larger , adequately powered sample is feasible and justified .


Moderate alcohol consumption has been associated with both negative and favorable effects on health .


The mechanisms responsible for reported favorable effects remain unclear .


Higher ( not necessarily elevated ) concentrations of serum bilirubin , an antioxidant , have also been associated with reduced risk of cardiovascular disease and all-cause mortality .


This study tests the hypothesis that single dose alcohol consumption elevates bilirubin providing a potential link between these observations .


@ healthy individuals ( eight cigarette smokers ) were administered alcohol , calibrated to achieve blood concentrations of @ , @ and @ mg/dL , in random order in three laboratory sessions separated by a week .


Each session was preceded by and followed by @-@ days of alcohol abstinence .


Serum bilirubin was measured at @:@ a.m. prior to drinking , at @p .


m. , and at @:@ the next morning .


Mixed effects regression models compared baseline and @h post-drinking bilirubin concentrations .


Total serum bilirubin ( sum of indirect and direct ) concentration increased significantly after drinking from baseline to @h in non-smokers ( from M = @ , SD = @ to M = @ , SD = @ , F ( @,@ ) = @ , p < @ ) but not in smokers ( from M = @ , SD = @ to M = @ , SD = @ , F ( @,@ ) = @ , p = @ ) .


In nonsmokers the indirect bilirubin concentration and the ratio of indirect ( unconjugated ) to direct ( conjugated ) bilirubin also increased significantly .


Alcohol consumption leads to increases in serum bilirubin in nonsmokers .


Considering the antioxidant properties of bilirubin , our findings suggest one possible mechanism for the reported association between alcohol consumption and reduced risk of some disorders that could be tested in future longitudinal studies .


Earlier initiation of antiretroviral therapy ( ART ) in HIV-tuberculosis ( TB ) is associated with increased immune reconstitution inflammatory syndrome ( IRIS ) .


The severity , frequency , and complications of TB IRIS were evaluated in A@ , a randomized trial of earlier ART ( within @ weeks after TB treatment initiation ) vs. later ART ( @-@ weeks after TB treatment ) in HIV-infected patients starting TB treatment .


In @ participants , TB IRIS was defined using published clinical criteria .


Cases were classified as severe ( hospitalization/death ) , moderate ( corticosteroid use/invasive procedure ) , or mild ( no hospitalization/procedures/steroids ) .


Fisher exact , Wilcoxon , and log-rank tests were used for comparisons .


TB IRIS occurred in @ ( @ % ) patients : @ % in earlier vs. @ % in later ART , @ % with CD@ < @ vs. @ % with CD@ @ cells per cubic millimeter .


The CD@/ART arm interaction was significant , P = @ , with @ % of TB IRIS occurring with CD@ < @ and earlier ART .


TB IRIS occurred sooner with earlier vs. later ART initiation , at a median of @ vs. @ days after TB treatment initiation ( P < @ ) .


IRIS manifestations included lymphadenopathy ( @ % ) , constitutional symptoms ( @ % ) , and radiographic changes ( @ % ) ; central nervous system TB IRIS was uncommon ( @ % ) .


TB IRIS was mild in @ % , moderate in @ % , and severe in @ % .


No TB IRIS-associated deaths occurred .


IRIS management required @ invasive procedures in @ % , hospitalization in @ % , and corticosteroids in @ % .


TB IRIS was more frequent with earlier ART initiation and CD@ < @ cells per cubic millimeter .


As ART is implemented earlier in HIV-TB coinfection , programs will require the diagnostic capabilities , clinical resources , and training necessary to manage TB IRIS .


Trelagliptin is a novel once-weekly oral DPP-@ inhibitor .


We assessed the efficacy and safety of trelagliptin versus the daily oral DPP-@ inhibitor alogliptin in Japanese patients with type @ diabetes .


We did a randomised , double-blind , active-controlled , parallel-group , phase @ , non-inferiority study at @ sites in Japan .


We included individuals with type @ diabetes inadequately controlled by diet and exercise .


We randomly assigned patients ( @:@:@ ) to receive trelagliptin ( @ mg ) once per week , alogliptin ( @ mg ) once per day , or placebo for @ weeks .


Randomisation was done electronically and independently from the study with permuted blocks of ten patients .


Patients and clinicians were masked to group assignment .


Patients in the trelagliptin group were given trelagliptin once a week and oral alogliptin placebo every day , whereas patients in the alogliptin group were given oral trelagliptin placebo once a week and oral alogliptin every day ( double-dummy design ) .


Patients in the placebo group were given an oral alogliptin placebo once a day and an oral trelagliptin placebo once a week .


Our primary outcome was between-groups difference in change in HbA@c concentration from baseline to the end of treatment .


The non-inferiority margin was @ % .


Our analysis included all patients who were randomised and received at least one dose of study drug .


The study is registered with ClinicalTrials.gov , number NCT@ .


Between May @ , @ , and Nov @ , @ , we enrolled @ patients .


@ patients were included in the analysis ( @ for trelagliptin , @ for alogliptin , and @ for placebo ) .


In the primary analysis , the least squares mean change in HbA@c concentration was -@ % in the trelagliptin group ( SE @ ) and -@ % in the alogliptin group ( @ ) based on the ANCOVA model .


The least squares mean difference ( trelagliptin minus alogliptin ) of change from baseline in HbA@c concentration was @ % ( @ % CI -@ to @ ) .


Trelagliptin was non-inferior to alogliptin .


Both active groups had significantly reduced mean HbA@c concentrations at end of treatment compared with placebo ( p < @ ) .


The frequency of adverse events was similar between groups .


No hypoglycaemia was reported with trelagliptin and the drug was well tolerated .


The once-weekly DPP-@ inhibitor trelagliptin showed similar efficacy and safety to alogliptin once daily in Japanese patients with type @ diabetes .


Trelagliptin could be a useful new antidiabetes drug that needs to be given once a week .


According to the literature , voice rest following phonosurgery , as recommended in clinical practice , varies between @ and @ days .


However , up until now , no randomized trials have been published comparing voice rest of short versus long duration .


This is an ongoing prospective randomized study , comparing strict voice rest of @ versus @ days on the voice following phonosurgery .


Thirty-one elective patients operated on for benign laryngeal lesions were randomized .


They completed pre - and postoperative assessments , including perceptual voice quality ( Grade , Roughness , Breathiness , Asthenia , Strain , Instability scale ) , Voice Handicap Index total score , and voice analysis with both acoustic and aerodynamic measurements .


Additional factors such as smoking , vocal abuse , reflux , and preoperative speech therapy were also taken into account .


Sixteen patients were randomized to follow @ days ' voice rest and @ patients were randomized to @ days ' voice rest .


Statistical analysis showed no significant differences in pre - or postoperative measurements between the @ groups .


However , multilinear regression analysis for the effect of voice rest duration on postoperative values showed a significant improvement in maximum phonation time ( MPT ) with @ days ' voice rest .


Preliminary results show a benefit of prolonged voice rest ( @ days ' duration ) on MPT .


To explore the efficacy and safety of fondaparinux combined with tirofiban in patients with high risk unstable angina ( UA ) undergoing complex percutaneous coronary intervention ( PCI ) .


A total of @ patients were enrolled and randomized into two groups receiving either fondaparinux with tirofiban or enoxaparin with tirofiban .


Bleeding , thrombosis and main adverse cardiovascular events ( MACE ) were compared between the two groups during hospitalization , at week @ and week @ after discharge .


No severe bleeding was observed during hospitalization in the both groups , while lower rate of mild and minor bleeding was shown in the fondaparinux group ( @ vs @ % and @ % vs @ % , P = @ and P < @ respectively ) .


No difference was found between the two groups in the rate of MACE during hospitalization , at week @ and week @ weeks after discharge .


The rates of death , recurrent myocardial infarction , refractory myocardial ischemia and target vessel revascularization were @ % vs @ % , @ % vs @ % , @ % vs @ % and @ % vs @ % during hospitalization ; @ vs @ , @ % vs @ % , @ % vs @ % , @ % vs @ % at week @ after discharge ; @ % vs @ % , @ % vs @ % , @ % vs @ % , @ vs @ % at week @ after discharge ( all P values > @ ) .


The combination therapy of fondaparinux and tirofiban is of good safety and efficacy in high risk UA patients undergoing complex PCI .


Insulin adjustments to maintain glycemic control in individuals with type @ diabetes often lead to wide glucose fluctuations , hypoglycemia , and increased body weight .


Dapagliflozin , an insulin-independent sodium-glucose cotransporter @ ( SGLT@ ) inhibitor , increases glucosuria and reduces hyperglycemia in individuals with type @ diabetes .


The primary objective of this study was to assess short-term safety of dapagliflozin in combination with insulin ; secondary objectives included pharmacokinetic , pharmacodynamic , and efficacy parameters .


A @-week , dose-ranging , randomized , double-blind , placebo-controlled proof-of-concept study randomly assigned @ adults with type @ diabetes ( HbA@c @-@ % ) , who were receiving treatment with stable doses of insulin , to one of four dapagliflozin doses ( @ , @ , @ , or @ mg ) or placebo .


The insulin dose was not proactively reduced at randomization but could be adjusted for safety reasons .


Sixty-two patients ( @ % ) completed the study .


Any hypoglycemia was common across all treatments ( @-@ @ % ) ; one major event of hypoglycemia occurred with dapagliflozin @ mg .


No diabetic ketoacidosis occurred .


Pharmacokinetic parameters were similar to those observed in patients with type @ diabetes .


Glucosuria increased by @ g/@ h ( @ % CI @ to @ ) with dapagliflozin @ mg and decreased by -@ g/@ h ( @ % CI -@ to @ ) with placebo .


Changes from baseline with dapagliflozin @ mg by day @ were as follows : -@ mmol/L ( @ % CI -@ to -@ -LSB- -@ mg/dL ; @ % CI -@ to -@ -RSB- ) for @-h daily average blood glucose ; -@ mmol/L ( @ % CI -@ to -@ -LSB- -@ mg/dL ; @ % CI -@ to -@ -RSB- ) for mean amplitude of glycemic excursion ; and -@ % ( @ % CI -@ to -@ ) for mean percent change in total daily insulin dose .


Corresponding changes with placebo were as follows : -@ mmol/L ( @ % CI -@ to @ ) , -@ mmol/L ( @ % CI -@ to @ ) , and @ % ( @ % CI -@ to @ ) , respectively .


However , for every efficacy parameter , the @ % CIs for all dapagliflozin doses overlapped those for placebo .


This exploratory study of dapagliflozin in adults with type @ diabetes demonstrated acceptable short-term tolerability and expected pharmacokinetic profiles and increases in urinary glucose excretion .


Within the dapagliflozin groups , dose-related reductions in @-h glucose , glycemic variability , and insulin dose were suggested , which provide hope that SGLT@ inhibition may prove in larger randomized controlled trials to be efficacious in reducing hyperglycemia in type @ diabetes .


To examine gender disparities in cognitive functioning in India and the extent to which education explains this disparity in later life .


This study uses baseline interviews of a prospective cohort study of @,@ community-residing adults @ years of age or older in four geographically diverse states of India ( Karnataka , Kerala , Punjab , Rajasthan ) .


Data collected during home visits includes cognitive performance tests , and rich sociodemographic , health , and psychosocial variables .


The cognitive performance tests include episodic memory , numeracy , and a modified version of the Mini-Mental State Examination .


We find gender disparity in cognitive function in India , and this disparity is greater in the north than the south .


We also find that gender disparities in educational attainment , health , and social and economic activity explain the female cognitive disadvantage in later life .


We report significant gender disparities in cognitive functioning among older Indian adults , which differ from gender disparities in cognition encountered in developed countries .


Our models controlling for education , health status , and social and economic activity explain the disparity in southern India but not the region-specific disparity in the northern India .


North Indian women may face additional sources of stress associated with discrimination against women that contribute to persistent disadvantages in cognitive functioning at older ages .


To evaluate an incentive-based intervention to increase time spent outdoors among children in a @-month cluster randomised controlled trial .


Two hundred and eighty-five children aged @-@years of age were randomised to the intervention ( n = @ ) or control arm ( n = @ ) in the Family incentive trial ( FIT ) .


The FIT intervention comprised of targeted education on myopia and good eye care habits , structured weekend outdoor activities and incentives for children to increase their daily steps via pedometers .


The main outcome measure was outdoor time , measured by the WHO questionnaire and a @-week diary .


Interim analysis at @months showed a significant increase in mean outdoor time per week in the intervention arm ( @ hweek ( -@ ) ) compared to the control arm ( @ hweek ( -@ ) ) as measured by the questionnaire ( p = @ ) .


However , greater outdoor time was not statistically significant at the end of the trial ( @ hweek ( -@ ) vs @ h in the control group ( p = @ ) .


There was an increase in outdoor time for children in the incentive-based physical activity outdoor program after @months but not at the end of the trial .


Further larger school trials with better compliance with the intervention and longer duration could be conducted to evaluate clinical outcomes such as myopic shifts .


Data are lacking on the long-term effect on cardiovascular events of adding sitagliptin , a dipeptidyl peptidase @ inhibitor , to usual care in patients with type @ diabetes and cardiovascular disease .


In this randomized , double-blind study , we assigned @,@ patients to add either sitagliptin or placebo to their existing therapy .


Open-label use of antihyperglycemic therapy was encouraged as required , aimed at reaching individually appropriate glycemic targets in all patients .


To determine whether sitagliptin was noninferior to placebo , we used a relative risk of @ as the marginal upper boundary .


The primary cardiovascular outcome was a composite of cardiovascular death , nonfatal myocardial infarction , nonfatal stroke , or hospitalization for unstable angina .


During a median follow-up of @ years , there was a small difference in glycated hemoglobin levels ( least-squares mean difference for sitagliptin vs. placebo , -@ percentage points ; @ % confidence interval -LSB- CI -RSB- , -@ to -@ ) .


Overall , the primary outcome occurred in @ patients in the sitagliptin group ( @ % ; @ per @ person-years ) and @ patients in the placebo group ( @ % ; @ per @ person-years ) .


Sitagliptin was noninferior to placebo for the primary composite cardiovascular outcome ( hazard ratio , @ ; @ % CI , @ to @ ; P < @ ) .


Rates of hospitalization for heart failure did not differ between the two groups ( hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) .


There were no significant between-group differences in rates of acute pancreatitis ( P = @ ) or pancreatic cancer ( P = @ ) .


Among patients with type @ diabetes and established cardiovascular disease , adding sitagliptin to usual care did not appear to increase the risk of major adverse cardiovascular events , hospitalization for heart failure , or other adverse events .


( Funded by Merck Sharp & Dohme ; TECOS ClinicalTrials.gov number , NCT@ . )


The primary aim of this study was to determine whether mesh pore size influences the rate of chronic pain at @-mo follow-up .


Another aim was to evaluate the rate of foreign body feeling and quality of life after inguinal hernia repair .


The patients were randomized into two study groups : the UM group received Ultrapro mesh ( pore size @-@ mm ) and the OM group received Optilene LP mesh ( pore size @ mm ) .


Pain scores were measured on a visual analog scale .


The feeling of a foreign body was a yes-or-no question .


Quality of life was evaluated using the Medical Outcome Study Short-Form-@ questionnaire .


A total of @ patients in the UM group and @ patients in the OM group were investigated @ mo after operation .


There were no significant differences in the results of the pain questionnaire between the study groups .


Of the patients , @ % in the UM group reported pain during different activities at @-mo follow-up versus @ % in the OM group ( P = @ ) .


The feeling of a foreign body in the inguinal region was experienced by @ % of the patients in the UM group and by @ % of the patients in the OM group at @-mo follow-up ( P = @ ; risk ratio @ , @ % confidence interval : @-@ @ ) .


There were no significant differences in the quality of life according to the Short-Form @ questionnaire between the two study groups at @-mo follow-up .


In both study groups , the quality of life scores improved after operation by most dimensions .


Differences in mesh pore size did not influence the rate of chronic pain .


Although there was a trend for higher rate of foreign body feeling in the study group where a mesh with larger pores was used , we failed to find an explanation for this .


The pore size of meshes investigated in this study did not affect the quality of life after inguinal hernia repair .


Considering the fact that the quality of life improved significantly after operation , elective repair of symptomatic inguinal hernias should be undertaken as promptly as possible .


Surgical site infections are the third most frequent type of nosocomial infections .


Evidence-based recommendations have been given regarding preoperative hospitalization , hygiene and air-conditioning , patient conditions , and wound dressing .


However , no general recommendations concerning wound closure exist .


Systematic reviews and meta-analyses suppose a benefit of intracutaneous suture compared to skin staples in orthopedic and obstetric surgery .


Literature data for skin closure in elective abdominal surgery are still deficient .


Patients scheduled for any elective abdominal surgery requiring midline or horizontal laparotomy are potentially eligible for the trial .


Trial-specific exclusion criteria are date of admission exceeding four days prior to surgery , antibiotic treatment within the past @ days , any previous midline or horizontal laparotomy in case the procedure requires the same skin incision as before , neurophysiological deficits or severe psychiatric or neurologic diseases that do not allow an informed consent or compliance , and participation in any other interventional trial with interference of intervention and outcome .


The trial is created for process innovation within standardized surgical procedures .


It is designed as a prospective randomized controlled single center trial in a parallel design including an active comparator and an intervention group .


The intervention addresses the closure of skin after the main surgical procedure : intracutaneous suture in the intervention group and transcutaneous skin stapling in the control group .


The rate of superficial surgical site infections is defined as the primary endpoint .


Secondary endpoints are time for skin closure , satisfaction with the cosmetic outcome @ days after surgery , prolongation of hospital stay , and duration of sick-leave due to surgical site infections .


The primary efficacy analysis follows the intention-to-treat principle .


A @ test will be applied .


The trial is expected to balance the shortcomings of the current evidence .


It will help to define the gold standard for wound closure in elective abdominal surgery .


Patients ' safety and quality of life are assumed to be enhanced .


Therapy costs are likely to be reduced and health care optimized .


Adjunctive behavioral smoking cessation treatments have the potential to improve outcomes beyond standard care .


The present study had two aims : ( @ ) compare standard care ( SC ) for smoking ( four weeks of brief counseling and monitoring ) to SC plus prize-based contingency management ( CM ) , involving the chance to earn prizes on days with demonstrated smoking abstinence ( carbon monoxide ( CO ) @ ppm ) ; and ( @ ) compare the relative efficacy of two prize reinforcement schedules-one a traditional CM schedule , and the second an early enhanced CM schedule providing greater reinforcement magnitude in the initial week of treatment but equal overall reinforcement .


Participants ( N = @ nicotine-dependent cigarette smokers ) were randomly assigned to one of the three conditions .


Prize CM resulted in significant reductions in cigarette smoking relative to SC .


These reductions were not apparent at follow-up .


We found no meaningful differences between the traditional and enhanced CM conditions .


Our findings reveal that prize CM leads to significant reductions in smoking during treatment relative to a control intervention , but the benefits did not extend long-term .


To study the therapeutic effect Bufei granule , which is a traditional Chinese drug that can enhance the immune function of the lung , on patients with stable chronic obstructive pulmonary disease ( COPD ) .


This is a randomized , double blinded , placebo-controlled , and multicenter clinical study .


Three medical centers in Tianjin , China , participated in the trial .


A total of @ patients with stable COPD were enrolled and randomized into two groups , with @ patients in each .


The treatment group was treated with Bufei granule , while the control group received Bufei placebo .


The pharmacological treatment lasted for @ weeks from the date of enrollment .


Then , the indexes of patients were observed .


Data were analyzed to study the effect of Bufei granule , with the frequency of acute exacerbation as the primary outcome .


Traditional Chinese Medicine syndromes , Modified British Medical Research Council dyspnea scale score , St. George 's respiratory questionnaire scores , pulmonary function , and serum inflammatory marker levels -LSB- including interleukin-@ ( IL-@ ) , interleukin-@ , tumor necrosis factor-alpha , and transformation growth factor-beta@ -RSB- were the secondary outcomes .


During the @-week treatment , treatment and control groups had no adverse reactions .


The analysis of the indexes obtained from all patients showed that the therapeutic effect in the treatment group was significantly better than that in the control group because most of the similar probabilities of primary and secondary outcomes were less than @ , except for the level of IL-@ .


Bufei granule can treat patients with stable COPD by lowering the frequency of acute exacerbation , improving the quality of life , and alleviating the severity of inflammation .


Early risk-stratified chemotherapy is a standard treatment for breast , colorectal , and lung cancers , but not for high-risk localised prostate cancer .


Combined docetaxel and estramustine improves survival in patients with castration-resistant prostate cancer .


We assessed the effects of combined docetaxel and estramustine on relapse in patients with high-risk localised prostate cancer .


We did this randomised phase @ trial at @ hospitals in France .


We enrolled patients with treatment-naive prostate cancer and at least one risk factor ( ie , stage T@-T@ disease , Gleason score of @ , prostate-specific antigen concentration > @ ng/mL , or pathological node-positive ) .


All patients underwent a staging pelvic lymph node dissection .


Patients were randomly assigned ( @:@ ) to either androgen deprivation therapy ( ADT ; goserelin @ mg every @ months for @ years ) plus four cycles of docetaxel on day @ at a dose of @ mg/m ( @ ) and estramustine @ mg/kg per day on days @-@ , every @ weeks , or ADT only .


The randomisation was done centrally by computer , stratified by risk factor .


Local treatment was administered at @ months .


Neither patients nor investigators were masked to treatment allocation .


The primary endpoint was relapse-free survival in the intention-to-treat population .


Follow-up for other endpoints is ongoing .


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


We randomly assigned @ patients to the ADT plus docetaxel and estramustine group and @ to the ADT only group .


Median follow-up was @ years ( IQR @-@ ) .


@ ( @ % ) of @ patients in the ADT plus docetaxel and estramustine group had an event ( relapse or death ) versus @ ( @ % ) of @ in the ADT only group .


@-year relapse-free survival was @ % ( @ % CI @-@ ) in the ADT plus docetaxel and estramustine group versus @ % ( @-@ ) in the ADT only group ( adjusted hazard ratio -LSB- HR -RSB- @ , @ % CI @-@ , p = @ ) .


Of patients who were treated with radiotherapy and had data available , @ ( @ % ) of @ in the ADT plus docetaxel and estramustine group versus @ ( @ % ) of @ in the ADT only group reported a grade @ or higher long-term side-effect ( p = @ ) .


We recorded no excess second cancers ( @ -LSB- @ % -RSB- of @ vs @ -LSB- @ % -RSB- of @ ; p = @ ) , and there were no treatment-related deaths .


Docetaxel-based chemotherapy improves relapse-free survival in patients with high-risk localised prostate cancer .


Longer follow-up is needed to assess whether this benefit translates into improved metastasis-free survival and overall survival .


Septic shock is common and has unacceptably high morbidity , mortality , and associated cost with numerous failed attempts at developing effective therapies .


Endotoxin , one of the most potent mediators of sepsis , is found in high levels in approximately @ % of patients with septic shock .


Polymyxin B ( PMX ) hemoperfusion has been shown in numerous studies to successfully remove endotoxin and potentially improve outcomes .