Prednisone was stopped abruptly , irrespective of the test results .


Patients discharged with pathological test results received instructions about emergency hydrocortisone treatment .


A total of @ patients were included in the analysis .


Mean basal and stimulated serum total cortisol levels were highest on admission ( @ and @nmol/l respectively ) and lowest on day @ ( @ and @nmol/l respectively ) .


Pathological stimulation tests were found in @ , @ , @ , @ , and @ % of patients on day @ , at discharge , and on days @ , @ , and @ respectively , without significant difference between treatment groups .


Clinical indicators of hypocortisolism did not correlate with stimulation test results , but cortisol levels were inversely associated with re-exacerbation risk .


There were no hospitalizations or deaths as a result of adrenal crisis .


Dynamic changes in the HPA axis occur during and after the treatment of acute exacerbations of COPD .


In hypocortisolemic patients who were provided with instructions about stress prophylaxis , the abrupt termination of prednisone appeared safe .


To compare the clinical efficacy of Black seeds and Turmeric alone and its co-administration in lower doses among patients with metabolic syndrome ( MetS ) .


Double-blind-randomized-controlled trial .


Hijrat colony , Karachi , Pakistan .


Apparently healthy males ( n = @ ) , who screened positive for MetS , were randomized to either Black seeds ( @ g/day ) , Turmeric ( @ g/day ) , its combination ( @mg Black seeds and @ g Turmeric/day ) or placebo for @ weeks .


body-mass-index ( BMI ) , body-fat-percent ( BF % ) , waist-circumference ( WC ) , hip-circumference ( HC ) , blood pressure ( BP ) , lipid-profile ( cholesterol , HDL-cholesterol , LDL-cholesterol and TG ) , fasting blood glucose ( FBG ) and c-reactive protein ( CRP ) .


At @ weeks , compared to baseline , Black seed and Turmeric alone showed improvement in BMI , WC and BF % .


Combination improved all parameters except HDL-cholesterol with lower FBG and LDL-cholesterol as compared to placebo .


At @ weeks , compared to placebo , Black seeds reduced lipids and FBG , while Turmeric reduced LDL-cholesterol and CRP .


Interestingly , combination group with @ % dose of the individual herbs showed an improvement in all parameters from baseline .


When compared to placebo , it reduced BF % , FBG , cholesterol , TG , LDL-cholesterol , CRP and raised HDL-cholesterol .


Turmeric and Black seeds showed improvement in all parameters of metabolic syndrome , when co-administered at @ % of doses of individual herbs with enhanced efficacy and negligible adverse-effects .


The combination of Black seeds and Turmeric can therefore , be recommended with lifestyle modification as a starting point for patients with MetS to halt its future complications and progression .


The aim of this study was to assess the effect of an active and novel distraction technique WITAUL ( Writing In The Air Using Leg ) on the pain behavior observed and reported by children receiving local anesthesia injections prior to dental treatment .


The study was conducted on @ children ( @ in control and @ in intervention group ) between the ages of @ - @ years .


During the administration of anesthesia the children in the control group were made to relax by means of deep breathing and those in the intervention group were taught to use the WITAUL distraction technique .


the behavior of the children aged @ - @ years was noted using the Modified Toddler - Preschooler Post operative Pain Scale ( TPPPS ) and that of children aged above @ years was measured using the FACES Pain Scale-Revised ( FPS-R ) .


The use of WITAUL was found to be statistically significant ( p value < @ ) compared to the control method in serving as a distraction and hence in managing pain during local anesthesia administration .


The mean Modified TPPPS scores ( @ - @ year olds ) for the WITAL group was @ + / - @ and that of the control was @ + / - @ .


The mean FPS-R scores ( @ - @ year olds ) for the WITAUL group was @ + / - @ and that of the control group was @ + / - @ .


The WITAUL technique therefore appears to be a simple and effective method of distraction during local anesthesia administration in pediatric patients .


Both antidepressant medications and psychological therapy are common treatments for depression in postpartum women .


Antidepressant treatment may have a number of practical disadvantages , including a preference by women to avoid medication while breastfeeding .


Consequently , more information about the relative benefits of the two modalities in the perinatal period is helpful .


In the treatment of depressive disorders there is some evidence that combination therapies ( pharmacological plus psychological treatment ) may be more efficacious than either form of mono-therapy in isolation .


However , in the treatment of postnatal depression , such evidence is limited .


Forty five postpartum women with a DSM-IV diagnosis of depression were randomised to receive either : @ ) cognitive behavioural therapy ( CBT ) ; @ ) sertraline , or @ ) a combination of both treatment modalities .


Psychometric measures were collected weekly for @ weeks , with a follow-up at @ weeks .


Symptoms of depression and anxiety were reduced to a significant degree following all three treatments .


CBT mono-therapy was found to be superior to both sertraline mono-therapy and combination therapy after @ weeks .


The CBT mono-therapy group appeared to display the most rapid initial gains after treatment commencement .


In this sample , a specialised CBT program for postnatal depression was found to be superior as a mono-therapy compared to sertraline , a commonly prescribed SSRI antidepressant .


This is in contrast to previous studies which have found no detectable difference in the efficacies of drug and psychological treatment for postnatal depression .


Unlike some previous work , this study allowed a statistically independent evaluation of CBT mono-therapy for postnatal depression compared to both antidepressant and combination therapy .


In line with previous studies in postpartum women , there was no detectable advantage of combining pharmacological and psychological treatments in the short term .


Determine changes in cognition and post-traumatic stress disorder ( PTSD ) symptoms in subjects with traumatic brain injury ( TBI ) exposed to @ atmospheres absolute ( atm abs ) breathing @ % oxygen vs. sham ( @ atm-abs air ) .


Fifty randomized subjects completed a total of @ exposures .


A concussion history was taken , then baseline , post-series , and six-week follow-up immediate post-concussion assessment and cognitive testing , Brain-checkers and PTSD Checklist for Military ( PCL-M ) tests were administered .


No statistically significant differences between groups were noted , but both groups improved .


Subgroups analyses , based on concussion history and individual test components , showed improvement in the treatment group vs. the sham .


These subgroups included the number of concussive events , time from event to consent , loss of consciousness , visual memory , processing , go -- no go , and simple reaction time .


There was no statistically significant difference between a sham and @ atm abs hyperbaric oxygen ( HBO@ ) in cognitive scores from ImPACT and Brain-checkers or composite scores in the PCL-M ; however both groups showed improvement .


Subgroups with favorable response to treatment are identified .


Future studies evaluating HBO@ should consider concussion histories or focus on validating subgroup response to determine HBO@ as a potential adjunctive treatment for persistent symptoms following TBI .


We conducted a prospective randomized controlled noninferiority trial to compare objective and subjective outcomes of retropubic tension-free vaginal tape ( TVT ) with those of transobturator tape ( TVT-O ) as primary treatment for stress urinary incontinence ( SUI ) in women .


The study was conducted at @ gynecology units in Austria and Germany ; regional and academic hospitals participated .


A total of @ patients were randomly assigned to undergo TVT or TVT-O .


A total of @ patients ( @ % ) were examined at @ months .


A negative cough stress test with stable cystometry to @ ml was seen in @ % of patients after TVT and in @ % after TVT-O ; @ % and @ % of patients , respectively , reported no pad use , and @ % of patients in both groups considered themselves much or very much better on the Patient Global Impression of Improvement ( PGI-I ) scale .


Quality of life ( QoL ) as assessed with the SF-@ Health Survey , Kings ' Health Questionnaire , ( KHQ ) , and EuroQol-@D ( EQ-@D ) was significantly improved in both arms , with no differences between arms .


There were no significant differences in postoperative pain or complications .


Results of this trial demonstrate noninferiority between TVT and TVT-O with regard to postoperative continence and QoL and suggest little difference in perioperative problems ( ClinicalTrials.gov NCT @ ) .


Hip fractures incur the greatest medical costs of any fracture .


Valid epidemiological data are important to monitor for time-dependent changes .


In Norway , hip fractures are registered in the Norwegian Patient Registry ( NPR ) , but no published national validation exists .


The aim of the present study was a national validation of NPR as a register for hip fractures using diagnostic codes ( ICD-@ S @-@ ) and/or procedure codes ( NOMESCO version @ NFBxy ( x = @-@ , y = @-@ ) or NFJxy ( x = @-@ , y = @-@ ) .


A nationwide , population-based cohort comprising a random sub-sample of @,@ hip fracture-related entries for the years @-@ was drawn from the NPR .


@ entries were defined by a combination of diagnostic and procedure codes ( subsample @ ) , @ entries were defined by diagnostic codes only ( subsample @ ) and @ entries were defined by procedure codes only ( subsample @ ) .


Accuracy was ascertained through comparison with discharge summaries , procedure notes and X-ray reports requested from @ health institutions .


Comparisons between groups were done by chi@ for categorical and t-test for continuous variables .


@ health records from @ institutions were reviewed .


High accuracy ( @ % , @ % C.I. @-@ @ % ) was found for subsample @ , a combination of diagnostic and procedure codes .


Coding errors were prominent in other subsamples .


Defining fractures by a combination of diagnostic and procedure codes , annual average hip fracture incidence in Norway was @,@ ( @ % C.I. @,@ -@,@ ) , excluding only @ % of all hip fractures defined by wider definitions .


Based on current coding practice in Norway , a reliable national estimate of hip fracture incidences is found by a combination of relevant ICD-@ and NOMESCO codes in the NPR .


This method may be used for monitoring epidemiological changes .


This study was undertaken to identify a preferred dosing strategy for patients undergoing coronary artery bypass grafting or valve replacement procedures with cardiopulmonary bypass .


Patients undergoing coronary artery bypass grafting , valve replacement surgery , or both were randomly assigned to receive either standard @-g dosing with vancomycin before and after cardiopulmonary bypass or a single weight-based @-mg/kg dose before surgery .


The primary outcome was the percentage of time plasma concentrations were greater than @ g/mL during cardiopulmonary bypass and at surgical closure .


Secondary outcomes included concentration of vancomycin in endothoracic tissue after vancomycin infusion , average time patients had vancomycin concentrations greater than @ g/mL , and vancomycin plasma and tissue pharmacokinetic parameters .


Baseline characteristics were similar between the study dosing group ( n = @ ) and the standard dosing group ( n = @ ) .


From postinfusion to end of bypass , the median percentage of time vancomycin concentrations remained greater than @ g/mL was @ % ( interquartile range -LSB- IQR -RSB- , @ % -@ % ) for weight-based dosing versus @ % ( IQR , @ % -@ % ) for standard dosing ( P = @ ) .


From postinfusion to surgical closure , the percentage of time vancomycin concentrations remained greater than @ g/mL was significantly higher in the weight-based group ( @ % -LSB- IQR , @ % -@ % -RSB- vs @ % -LSB- IQR , @ % -@ % -RSB- ; P = @ ) .


Weight-based dosing increased calculated time with vancomycin concentrations greater than @ g/mL and resulted in higher endothoracic tissue vancomycin concentrations .


Weight-based vancomycin dosing before coronary artery bypass grafting or valve replacement results in vancomycin concentrations greater than @ g/mL consistently more than does standard @-g dosing .


Numerous open trials have demonstrated the beneficial clinical effects of aspirin desensitization ( AD ) in patients with aspirin-induced asthma ( AIA ) .


These beneficial effects might be attributable to aspirin 's potent anti-inflammatory properties , but that supposition requires further corroboration .


We sought to compare the clinical and biochemical responses to chronic oral AD in @ patients with AIA and @ patients with aspirin-tolerant asthma ( ATA ) .


All of the patients had chronic rhinosinusitis and nasal polyposis , and these responses were investigated in a pilot , double-blind , placebo-controlled study .


Twelve patients with AIA and @ patients with ATA were randomly assigned to receive @ mg of aspirin , and @ patients with AIA and @ patients with ATA received placebo .


Both aspirin and placebo were administered once daily for @ months .


Nasal symptoms , Sino-Nasal Outcome Test ( SNOT@ ) scores , peak nasal inspiratory flows , Asthma Control Questionnaire scores , spirometric parameters , peak expiratory flows , blood eosinophilia , and corticosteroid doses were assessed on a monthly basis .


Levels of urinary leukotriene E@ and the stable plasma prostaglandin ( PG ) D@ metabolite @,@-PGF@ were evaluated at baseline and after @ , @ , @ , and @ months .


Only the patients with AIA subjected to AD reported improvements in smell and reductions in sneezing and nasal blockade .


The SNOT@ and Asthma Control Questionnaire scores of these patients decreased , and their peak nasal inspiratory flows increased .


The dosages of inhaled corticosteroids were reduced .


There were no changes in leukotriene E ( @ ) or @,@-PGF ( @ ) levels after AD .


The clinically beneficial effects of AD on nasal and bronchial symptoms occurred only in the patients with AIA .


To evaluate repeated subgingival air-polishing in residual pockets with a new erythritol powder containing @ % chlorhexidine .


Single-centre , examiner masked , randomized clinical trial of @months with a two-arm , within-subject parallel design .


Fifty patients in periodontal maintenance were monitored in @-month intervals .


At months @ , @ , @ and @ , all sites presenting with a probing depth ( PD ) > @mm were subject to subgingival air-polishing ( test side ) or ultrasonic debridement ( control side ) .


The primary endpoint was presence/absence of PD > @mm after @months .


Totally @ sites were monitored at baseline , @ of them had a PD > @mm ( range @-@mm ) .


The number of pockets > @mm per subject , PD and bleeding on probing were significantly lower at month @ .


Differences between test and control were not significant .


There was a significant difference in favour of air-polishing for the perception of pain/discomfort .


Differences of frequencies at > @ and > @,@ cells/ml of six microorganisms between baseline and month @ were not significant .


At month @ , test sites were less frequently positive for Aggregatibacter actinomycetemcomitans at > @cells/ml than controls , and counts never exceeded @,@ cells/ml .


Repeated subgingival air-polishing reduced the number of pockets > @mm similar to ultrasonic debridement .


It was safe and induced less pain .


Lumbar puncture ( LP ) is one of the most common procedures performed in medicine .


The aim of this prospective study is to determine the success rate of LP in lateral decubitus with @-degree head-up tilt position , and compare it with traditional positions like sitting and lateral decubitus .


Three hundred and thirty patients between @ and @ years of age who had undergone abdominal , urologic , and lower limb extremities surgeries were enrolled and @ patients were divided into three different groups .


The LP was performed with a @-G atraumatic needle , either in the standard sitting position ( group S , n = @ ) , lateral decubitus , knee-chest position ( group L , n = @ ) or lateral decubitus , knee-chest position with a @-degree head-up tilt ( group M , n = @ ) .


The free flow of clear cerebrospinal fluid ( CSF ) upon first attempt was considered to be evidence of a successful LP .


Total LP success rate was significantly higher in group M ( @ % ) than in groups S and L ( @ and @ % , respectively ) ( p = @ ) .


When the significance between the groups was evaluated according to age , the increase in the LP success rate was not significant for @ and > @ age groups .


There were no differences among the three groups in terms of bloody CSF ( p = @ ) and the number of attempts before dural puncture ( p = @ ) .


The lateral decubitus in knee-chest position with a @-degree head-up tilt may be the preferred position for spinal anesthesia in young and elderly patients , due to the high success rate .


Classification of chronic heart failure ( HF ) is on the basis of criteria that may not adequately capture disease heterogeneity .


Improved phenotyping may help inform research and therapeutic strategies .


This study used cluster analysis to explore clinical phenotypes in chronic HF patients .


A cluster analysis was performed on @ baseline clinical variables from @,@ participants in the HF-ACTION ( Heart Failure : A Controlled Trial Investigating Outcomes of Exercise Training ) study , which evaluated exercise training versus usual care in chronic systolic HF .


An association between identified clusters and clinical outcomes was assessed using Cox proportional hazards modeling .


Differential associations between clinical outcomes and exercise testing were examined using interaction testing .


Four clusters were identified ( ranging from @ to @ patients in each ) , in which patients varied considerably among measures of age , sex , race , symptoms , comorbidities , HF etiology , socioeconomic status , quality of life , cardiopulmonary exercise testing parameters , and biomarker levels .


Differential associations were observed for hospitalization and mortality risks between and within clusters .


Compared with cluster @ , risk of all-cause mortality and/or all-cause hospitalization ranged from @ ( @ % confidence interval -LSB- @ % CI -RSB- : @ to @ ) for cluster @ to @ ( @ % CI : @ to@ @ ) for cluster @ .


However , for all-cause mortality , cluster @ had a disproportionately lower risk of @ ( @ % CI : @ to @ ) .


Evidence suggested differential effects of exercise treatment on changes in peak oxygen consumption and clinical outcomes between clusters ( p for interaction < @ ) .


Cluster analysis of clinical variables identified @ distinct phenotypes of chronic HF .


Our findings underscore the high degree of disease heterogeneity that exists within chronic HF patients and the need for improved phenotyping of the syndrome .


( Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure ; NCT@ ) .


Despite the considerable injury burden attributable to falls at home among the general population , few effective safety interventions have been identified .


We tested the safety benefits of home modifications , including handrails for outside steps and internal stairs , grab rails for bathrooms , outside lighting , edging for outside steps , and slip-resistant surfacing for outside areas such as decks and porches .


We did a single-blind , cluster-randomised controlled trial of households from the Taranaki region of New Zealand .


To be eligible , participants had to live in an owner-occupied dwelling constructed before @ and at least one member of every household had to be in receipt of state benefits or subsidies .


We randomly assigned households by electronic coin toss to either immediate home modifications ( treatment group ) or a @-year wait before modifications ( control group ) .


Household members in the treatment group could not be masked to their assigned status because modifications were made to their homes .


The primary outcome was the rate of falls at home per person per year that needed medical treatment , which we derived from administrative data for insurance claims .


Coders who were unaware of the random allocation analysed text descriptions of injuries and coded injuries as all falls and injuries most likely to be affected by the home modifications tested .


To account for clustering at the household level , we analysed all injuries from falls at home per person-year with a negative binomial generalised linear model with generalised estimating equations .


Analysis was by intention to treat .


This trial is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN@ .


Of @ households recruited , @ ( n = @ individual occupants ) were randomly assigned to the treatment group and @ ( n = @ occupants ) were allocated to the control group .


After a median observation period of @ days ( IQR @-@ ) , the crude rate of fall injuries per person per year was @ in the treatment group and @ in the control group ( relative rate @ , @ % CI @-@ @ ) .


The crude rate of injuries specific to the intervention per person per year was @ in the treatment group and @ in the control group ( @ , @-@ @ ) .


A @ % reduction in the rate of injuries caused by falls at home per year exposed to the intervention was estimated in people allocated to the treatment group compared with those assigned to the control group , after adjustment for age , previous falls , sex , and ethnic origin ( relative rate @ , @ % CI @-@ @ ) .


Injuries specific to the home-modification intervention were cut by @ % per year exposed ( @ , @-@ @ ) .


Our findings suggest that low-cost home modifications and repairs can be a means to reduce injury in the general population .


Further research is needed to identify the effectiveness of particular modifications from the package tested .


Enterovirus @ ( EV@ ) has caused several epidemics of hand , foot and mouth diseases ( HFMD ) in Asia .


No effective EV@ vaccine is available .


A randomized and open-label phase I clinical study registered with ClinicalTrials.gov #NCT @ , aims to evaluate the safety , reactogenicity and immunogenicity of a formalin-inactivated EV@ vaccine candidate ( EV@vac ) at @ - and @-g doses .


In this study we report the cross-neutralizing antibody responses from each volunteer against different subgenotypes of EV@ and CVA@ .


Sixty eligible healthy adults were recruited and vaccinated .


Blood samples were obtained on day @ , @ and @ and tested against B@ , B@ , B@ , C@ , C@A , C@B and CVA@ for cross-neutralizing antibody responses .


The immunogenicity of both @ - and @ - g doses were found to be very similar .


Approximately @ % of the participants had < @ pre-vaccination neutralization titers ( Nt ) against the B@ vaccine strain .


After the first EV@vac immunization , @ % of vaccinees have > @-fold increase in Nt , but there was no further increase in Nt after the second dose .


EV@vac induced very strong cross-neutralizing antibody responses in > @ % of volunteers without pre-existing Nt against subgenotype B@ , B@ and C@A .


EV@vac elicited weak cross-neutralizing antibody responses ( @ % of participants ) against a C@B and Coxsackie virus A@ .


Over @ % of vaccinated volunteers did not develop cross-neutralizing antibody responses ( Nt < @ ) against a C@ strain .


EV@vac can boost and significantly enhance the neutralizing antibody responses in volunteers who already had pre-vaccination antibodies against EV@ and/or CVA@ .


EV@vac is efficient in eliciting cross-neutralizing antibody responses against EV@ subgenotypes B@ , B@ , B@ , and C@A , and provides the rationale for its evaluation in phase II clinical trials .


Microemboli are frequently detected entering the middle cerebral arteries during coronary angiography ( CA ) .


Recent studies have reported that cerebral microemboli , especially particulate cerebral microemboli , may cause silent ischemic cerebral lesions .


To investigate whether the occurrence of particulate cerebral microemboli during diagnostic CA is influenced by which guidewire technique is used .


Patients with stable angina pectoris or non-ST elevation acute coronary syndrome , referred for CA , were randomized to initial advancement of catheters with a leading guidewire over the aortic arch or to initial guidewire withdrawal in the descending aorta with advancement of catheters alone .


After completed CA ( part @ ) , new catheters and guidewires were advanced with guidewire technique contrary to the one first used ( part @ ) .


Patients were continuously monitored with transcranial Doppler ( TCD ) , and cerebral microemboli were automatically counted and differentiated .


Statistical analysis was performed on @ patients .


The results in part @ were confirmed in part @ .


The median number ( interquartile range ) of particulate cerebral microemboli was significantly higher when catheters were advanced with , compared to without , a guidewire over the aortic arch ; overall , @ ( IQR , @-@ ) vs @ ( IQR , @-@ ) ; P = @ .


Advancement of catheters with a leading guidewire over the aortic arch with subsequent flushing in the ascending aorta consistently generated more particulate cerebral microemboli , implying that the choice of guidewire technique has an impact on the risk for cerebral lesions during CA .


Bortezomib-melphalan-prednisone ( VMP ) has improved overall survival in multiple myeloma .


This randomized trial compared VMP plus thalidomide ( VMPT ) induction followed by bortezomib-thalidomide maintenance ( VMPT-VT ) with VMP in patients with newly diagnosed multiple myeloma .


We randomly assigned @ patients who were not eligible for transplantation to receive VMPT-VT ( nine @-week cycles of VMPT followed by @ years of VT maintenance ) or VMP ( nine @-week cycles without maintenance ) .


In the initial analysis with a median follow-up of @ months , VMPT-VT improved complete response rate from @ % to @ % and @-year progression-free-survival ( PFS ) from @ % to @ % compared with VMP .


In this analysis , median follow-up was @ months .


The median PFS was significantly longer with VMPT-VT ( @ months ) than with VMP ( @ months ; hazard ratio -LSB- HR -RSB- , @ ; P < @ ) .


The time to next therapy was @ months in the VMPT-VT group and @ months in the VMP group ( HR , @ ; P < @ ) .


The @-year overall survival ( OS ) was greater with VMPT-VT ( @ % ) than with VMP ( @ % ; HR , @ ; P = @ ) .


Survival from relapse was identical in both groups ( HR , @ ; P = @ ) .


In the VMPT-VT group , the most frequent grade @ to @ adverse events included neutropenia ( @ % ) , thrombocytopenia ( @ % ) , peripheral neuropathy ( @ % ) , and cardiologic events ( @ % ) .


All of these , except for thrombocytopenia , were significantly more frequent in the VMPT-VT patients .


Bortezomib and thalidomide significantly improved OS in multiple myeloma patients not eligible for transplantation .


Binge-eating disorder ( BED ) , a public health problem associated with psychopathological symptoms and obesity and possibly with metabolic syndrome , lacks approved pharmacotherapies .


To examine the efficacy and safety of lisdexamfetamine dimesylate , a dextroamphetamine prodrug , to treat moderate to severe BED .


We performed a randomized , double-blind , parallel-group , forced dose titration , placebo-controlled clinical trial at @ sites from May @ , @ , through January @ , @ .


Safety and intention-to-treat analyses included @ and @ adults with BED , respectively .


Lisdexamfetamine dimesylate at dosages of @ , @ , or @ mg/d or placebo were provided to study participants ( @:@:@:@ ) .


Dosages were titrated across @ weeks and maintained for @ weeks .


We followed up participants for a mean ( SD ) of @ ( @ ) days after the last dose .


We assessed the change in binge-eating ( BE ) behaviors measured as days per week ( baseline to week @ ) with a mixed-effects model using transformed log ( BE days per week ) +@ .


Secondary measures included BE cessation for @ weeks .


Safety assessments included treatment-emergent adverse events , vital signs , and change in weight .


At week @ , log-transformed BE days per week decreased with the @-mg/d ( least squares -LSB- LS -RSB- mean -LSB- SE -RSB- change , -@ -LSB- @ -RSB- ; P = @ ) and @-mg/d ( LS mean -LSB- SE -RSB- change , -@ -LSB- @ -RSB- ; P < @ ) treatment groups but not the @-mg/d treatment group ( LS mean -LSB- SE -RSB- change , -@ -LSB- @ -RSB- ; P = @ ) compared with the placebo group .


Nontransformed mean ( SD ) days per week decreased for placebo and the @ - , @ - , and @-mg/d treatment groups by -@ ( @ ) , -@ ( @ ) , -@ ( @ ) , and -@ ( @ ) , respectively .


The percentage of participants achieving @-week BE cessation was lower with the placebo group ( @ % ) compared with the @-mg/d ( @ % -LSB- P = @ -RSB- ) and @-mg/d ( @ % -LSB- P < @ -RSB- ) treatment groups .


The incidence of any treatment-emergent adverse events was @ % for the placebo group and @ % for the combined treatment group .


In the treatment groups , @ % of participants had serious treatment-emergent adverse effects .


Events with a frequency of at least @ % and changes in heart rate were generally consistent with the known safety profile .


The mean ( SD ) change in body weight was -@ ( @ ) , -@ ( @ ) , -@ ( @ ) , -@ ( @ ) , and -@ ( @ ) kg for the placebo group , the @ - , @ - , and @-mg/d treatment groups , and the combined treatment groups , respectively ( P < @ for each dose vs placebo group comparison in post hoc analysis ) .


The @ - and @-mg/d treatment groups demonstrated efficacy compared with the placebo group in decreased BE days , BE cessation , and global improvement .


The safety profile was generally consistent with previous findings in adults with attention-deficit/hyperactivity disorder .


Further investigation of lisdexamfetamine in BED is ongoing .


To investigate the safety and satisfaction of patients treated @ days after unilateral bunionectomy with extended-release oxycodone/acetaminophen ( ER OC/APAP ) , a biphasic ( ER and immediate release ) fixed-dose combination analgesic being developed for moderate to severe acute pain .


This was an open-label extension ( OLE ) of a randomized , double-blind , placebo-controlled trial ( DBRCT ) of patients undergoing bunionectomy .


Patients who consented to the OLE before entering the @ hour DBRCT entered the OLE upon completing the DBRCT and during the OLE received two tablets of ER OC/APAP ( @/@mg total dose ) every @ hours for @ days .


ClinicalTrials identifier : NCT@ .


Treatment-emergent adverse events , physical examinations , vital sign measurements , and clinical laboratory testing were assessed throughout the study .


Global assessments of treatment satisfaction were made at the end of the DBRCT and at each clinic visit during the OLE .


A total of @ patients consented to the OLE before entering the DBRCT and @ completed the OLE .


Tolerability of ER OC/APAP during the OLE was consistent with that of an opioid product .


Adverse events occurred during the OLE in @ patients ( @ % ) ; the most common were gastrointestinal events including nausea ( @ % ) , vomiting ( @ % ) , and constipation ( @ % ) .


No changes in vital signs or clinical laboratory tests were considered by the investigator to be clinically significant .


At all visits during the OLE , the majority of patients were satisfied or very satisfied with their medication .


Limitations include a @ day postprocedure study duration that may be confounded with natural healing time , and lack of a placebo arm .


These results show that ER OC/APAP demonstrated an expected safety and tolerability profile and good patient satisfaction in a postsurgical model of acute pain .


To assess whether the addition of heated humidified gas ( HHG ) at delivery and until neonatal unit arrival improved admission temperatures of preterm infants .


This multicenter , randomized controlled trial was performed in New Zealand and The Netherlands .


Infants < @ weeks ' gestation who required respiratory support after delivery were randomized to either cold , dry gas or HHG from birth .


Standard measures to prevent hypothermia included heated delivery rooms , the use of radiant warmers , body wrap , and head covering .


The primary outcome was axillary temperature in the normothermic ( @-@ @ C ) range on admission to a neonatal intensive care unit .


Secondary outcomes were measures of respiratory support and neonatal morbidities .


The effect of humidification was analyzed by the use of logistic regression .


Of @ randomized infants , @ received HHG ( humidifier set to @C ) and @ received cold , dry gas .


In the HHG group , @ ( @ % ) were normothermic compared with @ ( @ % ) in the cold , dry gas group ( unadjusted OR @ , @ % CI @-@ @ ) .


A greater number of infants < @ weeks were normothermic on admission in the HHG group ( @/@ ; ie , @ % ) compared with the cold , dry gas group ( @/@ ; ie , @ % ; P = @ ) .


In addition , @ ( @ % ) infants in the HHG group had admission temperatures < @ C compared with @ ( @ % ) in the cold , dry gas group ( P = @ ) .


Respiratory and short-term outcomes were not different .


Adding HHG during respiratory support in preterm infants from birth increased the incidence of normothermia at admission .


On-call duty ( OCD ) is frequently associated with health and safety risks for both physicians and patients .


The lack of studies conducted in clinical care environments and the ongoing public dialogue concerning OCD led to a detailed investigation of a working schedule including sleep fragmentation and extended work hours .


Within-person randomized cross-over trial .


Comparison of a @h on-call shift ( OCD ) compared to a routine working-day ( non on call , NOC ) in hospital .


@ residents and senior physicians of the Department of Internal Medicine , Neurology and Otorhinolaryngology at the University Hospital Innsbruck .


Sleep variables , cognitive performance ( Concentration-Endurance d@ test ) , emotional status ( Eigenschaftswoerterliste @S ) , serum-cortisol , urinary cortisol and noradrenaline , heart-rate variability , and saccadic eye movements were determined before and after OCD and NOC respectively .


Concentration-endurance performance was significantly reduced after OCD as compared to NOC by @ % ( p < @ ) .


Changes in emotional status consisted in a reduction of subjective concentration and performance related activation after OCD by @ % ( p < @ ) and @ % ( p < @ ) respectively together with a @ % increase of general deactivation ( p < @ ) and a @ % rise of fatigue ( p < @ ) .


On the contrary , subjective activation and raised mood showed an @ % and @ % increase after OCD ( p < @ ) .


Urinary noradrenaline excretion ( @ g/@ h , @-@ ) was greater during OCD when compared to NOC ( @ g/@ h , @-@ , p < @ ) .


Sympathetic activity measured by heart rate variability was significantly higher during OCD in contrast to NOC ( p < @ ) .


Serum-cortisol was lower in the morning after ( @ ng/l , @-@ ) than the morning before OCD ( p < @ ) .


Finally , the number of short saccadic latencies was reduced after OCD ( p < @ ) compared to NOC .


@ h OCD alters both , the sympathetic-adrenomedullary system as well as the hypothalamic pituitary-adrenocortical axis .


Moreover , physicians ' emotional state , cognitive and oculomotor performance seems to be influenced independently from sleep interruptions .


The discrepancy between subjective feeling and objective cognitive impairments pose a risk for performing complex manual and cognitive tasks .


Hence , our findings argue against an oversimplified interpretation of alterations in the physicians ' psychoneuroendocrine structure in terms of impaired mood and neurocognitive deterioration combined with up - / dysregulated stress axes associated with OCD as a consequence of sleep deprivation .


Tooth loss affects oral health-related life quality .


More than a third of edentulous patients are not fully satisfied with their complete dentures and mainly complain of insufficient stability , retention , and pain during mastication .


Solving the problem may include relining by materials that are based on silicone or acrylic .


The aim of this study was to determine the level of patients ' satisfaction before and after relining upper dentures with soft and rigid liners .


The patients ( n = @ ) were divided into two study groups .


Maxillary denture relining of the first group of patients was performed with hard acrylic based resins while in the second group of patients complete denture was relined with a silicone-based soft liner .


They were asked the questions from the specifically adapted the Oral Health Impact Profile Questionnaire for edentulous patients before and three months after relining dentures .


After relining the patients showed a higher degree of satisfaction with their dentures in all the tested domains ( masticatory function , psychological discomfort , social disability and retention and hygiene ) .


The padents with soft denture relines were more satisfied .


Refining of maxillary complete dentures significantly positively impacts the quality of life of patients in all the tested domains ( masticatory function , psychological discomfort , social disability , pain and oral hygiene ) .


Better results were achieved using a silicone-based soft liner , which recommends it as the material of choice for relining dentures .


Evidence that rider training reduces motorcycle-related injuries or crashes is currently lacking .


However , significant community demand for training persists , which in turn can influence policy .


The present study aims to contribute to the understanding of this demand via two objectives : to ( @ ) offer a method , namely , contingent valuation , to measure the value motorcyclists place on training and ( @ ) examine determinants of such value .


Value was elicited through a willingness to question , using a bidding format , novice motorcyclists who were randomly assigned to groups either offered the training or not .


The group that was offered and subsequently received training provided a lower mean perceived value of the training than the group that was not .


Perceived value increased with rider age and decreased with training participation and near-crash experiences , controlling for bidding order , income , education , and experience of other training .


This study demonstrates the utility of contingent valuation in quantifying the perceived value of training , as well as the modifiability of perceived value , with age , training participation , and near-crash experiences as key determinants .


This indicates that research to determine ways to align the perceived value with evidence on training effectiveness is worthwhile in order to facilitate more appropriate and justified allocation of road safety resources .


Potential options to explore and evaluate may include community education on evidence of training effectiveness as well as alternative measures with demonstrated effectiveness in reducing crash risks .


Earlier antiretroviral therapy ( ART ) initiation in cryptococcal meningitis resulted in higher mortality compared with deferred ART initiation ( @-@ weeks vs @ weeks postmeningitis diagnosis ) .


We hypothesized this was due to ART-associated immune pathology , without clinically recognized immune reconstitution inflammatory syndrome .


Three macrophage activation markers and @ cytokines/chemokines were measured from cryopreserved cerebrospinal fluid ( CSF ) and serum during the Cryptococcal Optimal ART Timing ( COAT ) trial .


Comparisons were made between trial arms ( early vs deferred ) at @ , @ , @ , and @ days following meningitis diagnosis .


More participants with early ART initiation had CSF white cell count ( WCC ) @/L at day @ ( @ % vs @ % ; P = @ ) , after a median of @-days ART .


Differences were mainly driven by participants with CSF WCC < @/L at meningitis diagnosis : @ % ( @/@ ) of such persons in the early ART group had CSF WCC @/L by day @ , compared with @ % ( @/@ ) in the deferred arm ( P = @ ) .


Furthermore , Kampala participants ( the largest site ) receiving early ART had higher day-@ CSF levels of interleukin-@ ( P = @ ) , sCD@ ( P = @ ) , sCD@ ( P = @ ) , and CCL@/MIP -@ ( P = @ ) , suggesting increased macrophage/microglial activation .


Early ART initiation in cryptococcal meningitis increased CSF cellular infiltrate , macrophage/microglial activation , and T helper @ responses within the central nervous system .


This suggests that increased mortality from early ART in the COAT trial was immunologically mediated .


Bronchiectasis is characterised by chronic cough , sputum production , and recurrent chest infections .


Pathogenesis is poorly understood , but excess neutrophilic airway inflammation is seen .


Accumulating evidence suggests that statins have pleiotropic effects ; therefore , these drugs could be a potential anti-inflammatory treatment for patients with bronchiectasis .


We did a proof-of-concept randomised controlled trial to establish if atorvastatin could reduce cough in patients with bronchiectasis .


Patients aged @-@ years were recruited from a secondary-care clinic in Edinburgh , UK .


Participants had clinically significant bronchiectasis ( ie , cough and sputum production when clinically stable ) confirmed by chest CT and two or more chest infections in the preceding year .


Individuals were randomly allocated to receive either high-dose atorvastatin ( @ mg ) or a placebo , given orally once a day for @ months .


Sequence generation was done with a block randomisation of four .


Random allocation was masked to study investigators and patients .


The primary endpoint was reduction in cough from baseline to @ months , measured by the Leicester Cough Questionnaire ( LCQ ) score , with a lower score indicating a more severe cough ( minimum clinically important difference , @ units ) .


Analysis was done by intention-to-treat .


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


Between June @ , @ , and Jan @ , @ , @ patients were screened for inclusion in the study and @ were excluded before randomisation .


@ individuals were assigned atorvastatin and @ were allocated placebo .


The change from baseline to @ months in LCQ score differed between groups , with a mean change of @ units in patients allocated atorvastatin versus -@ units in those assigned placebo ( mean difference @ , @ % CI @-@ ; p = @ ) .


@ ( @ % ) of @ patients in the atorvastatin group improved by @ units or more on the LCQ compared with five ( @ % ) of @ in the placebo group ( difference @ % , @ % CI @-@ ; p = @ ) .


Ten ( @ % ) patients assigned atorvastatin had an adverse event versus three ( @ % ) allocated placebo ( difference @ % , @ % CI @-@ ; p = @ ) .


No serious adverse events were recorded .


@ months of atorvastatin improved cough on a quality-of-life scale in patients with bronchiectasis .


Multicentre studies are now needed to assess whether long-term statin treatment can reduce exacerbations .


An association between GB virus C ( GBV-C ) and improved outcomes of human immunodeficiency virus ( HIV ) infection has been reported in HIV-positive individuals with active GBV-C coinfection .


This study provides insights into the immune mechanisms underlying the protective role of GBV-C in HIV-infected patients .


The concentrations of @ cytokines and chemokines were measured in plasma samples obtained from the Viral Activation Transfusion Study cohort before transfusion and longitudinally from @ patients positive for both HIV and GBV-C ( hereafter , `` cases '' ) and @ patients positive for HIV and negative for GBV-C ( hereafter , `` controls '' ) .


Cases had lower HIV viral loads and higher CD@ T-cell counts than controls after acquisition of GBV-C infection .


Most of the modulated cytokines and chemokines were reduced after GBV-C detection , including many proinflammatory cytokines , suggesting an overall antiinflammatory effect of GBV-C in HIV-positive subjects .


Most pathways and functions of the measured cytokines were downregulated in cases , except cell death pathways , which were upregulated in various cell subsets in the @ months after GBV-C detection .


GBV-C has a protective effect , in part through a competition mechanism leading to decreased inflammation and improved HIV disease outcome in cases .


Further studies are necessary to establish whether GBV-C may have deleterious effects on the host at the cellular level , including depleting the cells that are the targets of HIV .


Atrial fibrillation and heart failure with reduced left ventricular ejection fraction have interrelated pathophysiologies .


New-onset atrial fibrillation in heart failure patients has been associated with increased mortality , but has not been definitively related to clinical heart failure progression .


To test the hypothesis that new-onset atrial fibrillation is related to clinical heart failure progression , in @ patients without atrial fibrillation at randomization in the Beta-blocker Evaluation of Survival Trial we measured clinical endpoints in patients who did ( Group @ , n = @ ) or did not ( Group @ , n = @ ) develop new-onset atrial fibrillation .


Results were also compared with the @ patients who entered the trial in atrial fibrillation ( Baseline/chronic group ) , and in Group @/@ patients we conducted a multivariate analysis of covariates potentially related to time to first heart failure hospitalization .


Compared with Group @ , Group @ patients post atrial fibrillation onset had a @-fold increase in mortality ( P < @ ) and a @-fold increase in all-cause or heart failure hospitalization days/patient ( hospitalization burden , both P < @ ) .


In Group @ , both types of hospitalization burden were @-fold greater than in the Baseline/chronic group ( P < @ ) , and hospitalization burden increased @-fold ( P < @ ) compared with the pre-event period .


On multivariate analysis , new-onset atrial fibrillation was a highly significant ( P < @ ) predictor of heart failure hospitalization .


In addition to being a discrete electrophysiologic event , in heart failure patients , new-onset atrial fibrillation is a predictor of and trigger for clinical heart failure progression .


Neoadjuvant endocrine therapy with an aromatase inhibitor has shown efficacy comparable to that of neoadjuvant chemotherapy in patients with postmenopausal breast cancer .


Preclinical and clinical studies have shown that the antidiabetic drug metformin has anti-tumor activity .


This prospective , multicenter , phase II randomized , placebo controlled trial was designed to evaluate the direct anti-tumor effect of metformin in non-diabetic postmenopausal women with estrogen-receptor ( ER ) positive breast cancer .


Patients meeting the inclusion criteria and providing written informed consent will be randomized to @ weeks of neoadjuvant treatment with letrozole ( @ mg/day ) and either metformin ( @ mg/day ) or placebo .


Target accrual number is @ patients per arm .


The primary endpoint will be clinical response rate , as measured by calipers .


Secondary endpoints include pathologic complete response rate , breast conserving rate , change in Ki@ expression , breast density change , and toxicity profile .


Molecular assays will be performed using samples obtained before treatment , at week @ , and postoperatively .


This study will provide direct evidence of the anti-tumor effect of metformin in non-diabetic , postmenopausal patients with ER-positive breast cancer .


Investigate the effect of inhaling @ g salbutamol for @ weeks on endurance , strength , and power performances .


Randomized double-blind , mixed-model repeated measures .


Sixteen male athletes ( mean SD : age , @ @ years ; height , @ @ cm ; weight , @ @ kg ) .


Participants were assigned to either a placebo inhaler ( PLA ) or inhaled @ g salbutamol group ( SAL ) .


Over @ weeks , participants inhaled PLA or SAL and completed @ training sessions per week that focused on endurance , strength , and power .


Participants completed the assessments of peak oxygen consumption ( V -LSB- Combining Dot Above -RSB- O@peak ) , @-km time trial , vertical jump height , @ repetition maximum ( @RM ) bench and leg press , and peak torque knee flexion and extension .


Assessments were undertaken at baseline , week @ , and week @ .


Over the @ weeks , PLA and SAL groups improved V -LSB- Combining Dot Above -RSB- O@peak ( @ @ vs @ @ mLminkg ; @ @ vs @ @ mLminkg ) ; @-km running time trial ( @ @ vs @ @ seconds ; @ @ vs @ @ seconds ) ; @RM bench press ( @ @ vs @ @ kg ; @ @ vs @ @ kg ) ; and leg press ( @ @ vs @ @ kg ; @ @ vs @ @ kg ) .


The SAL group did not improve significantly greater in any endurance or strength and power measure when compared with the PLA group .


Inhaling @ g salbutamol daily over @ weeks does not result in significant improvements in endurance , or strength and power performances .


Athletes using inhaled salbutamol to treat bronchoconstriction during exercise on a daily basis will not gain an advantage over nonasthmatic athletes not using inhaled salbutamol .


Neurology is complex , abstract , and difficult for students to learn .


However , a good learning method for neurology clerkship training is required to help students quickly develop strong clinical thinking as well as problem-solving skills .


Both the traditional lecture-based learning ( LBL ) and the relatively new team-based learning ( TBL ) methods have inherent strengths and weaknesses when applied to neurology clerkship education .


However , the strengths of each method may complement the weaknesses of the other .


Combining TBL with LBL may produce better learning outcomes than TBL or LBL alone .


We propose a hybrid method ( TBL+LBL ) and designed an experiment to compare the learning outcomes with those of pure LBL and pure TBL .


One hundred twenty-seven fourth-year medical students attended a two-week neurology clerkship program organized by the Department of Neurology , Sun Yat-Sen Memorial Hospital .


All of the students were from Grade @ , Department of Clinical Medicine , Zhongshan School of Medicine , Sun Yat-Sen University .


These students were assigned to one of three groups randomly : Group A ( TBL+LBL , with @ students ) , Group B ( LBL , with @ students ) , and Group C ( TBL , with @ students ) .


The learning outcomes were evaluated by a questionnaire and two tests covering basic knowledge of neurology and clinical practice .


The practice test scores of Group A were similar to those of Group B , but significantly higher than those of Group C.


The theoretical test scores and the total scores of Group A were significantly higher than those of Groups B and C.


In addition , @ % of the students in Group A were satisfied with the combination of TBL+LBL .


Our results support our proposal that the combination of TBL+LBL is acceptable to students and produces better learning outcomes than either method alone in neurology clerkships .


In addition , the proposed hybrid method may also be suited for other medical clerkships that require students to absorb a large amount of abstract and complex course materials in a short period , such as pediatrics and internal medicine clerkships .


To study the short-term response and tolerance of different doses of amino acids in parenteral nutrition among preterm infants .


This study included @ preterm infants who had a birth weight between @ to @g and were admitted to the hospital within @ hours of birth between March @ and June @ .


According to the early application of different doses of amino acids , they were randomized into low-dose group ( n = @ , @ g/kg per day with an increase of @ g/kg daily and a maximum of @ g/kg per day ) , medium-dose group ( n = @ , @ g/kg per day with an increase of @ g/kg daily and a maximum of @ g/kg per day ) , and high-dose group ( n = @ , @ g/kg per day with an increase of @-@ @ g/kg daily and a maximum of @ g/kg per day ) .


Other routine parenteral nutrition and enteral nutrition support were also applied .


The maximum weight loss was lower and the growth rate of head circumference was greater in the high-dose group than in the low-dose group ( P < @ ) .


The infants in the medium - and high-dose groups had faster recovery of birth weight , earlier attainment of @ kcal / ( kgd ) of enteral nutrition , shorter duration of hospital stay , and less hospital cost than those in the low-dose group ( P < @ ) .


Blood urea nitrogen ( BUN ) levels in the high-dose group increased compared with the other two groups @ days after birth ( P < @ ) .


The levels of creatinine , pH , bicarbonate , bilirubin , and transaminase and the incidence of complications showed no significant differences between groups ( P > @ ) .


Parenteral administration of high-dose amino acids in preterm infants within @ hours after birth can improve the short-term nutritional status of preterm infants , but there is a transient increase in BUN level .


Prospective randomized studies comparing internal fixation and a cemented hip replacement in the treatment of displaced femoral neck fractures have shown favorable short-term results for prosthetic replacement .


The present report compares the results after a minimum of fifteen years .


From @ to @ , @ patients ( @ hips ) were randomized to closed reduction and internal fixation with two screws ( n = @ ) or a cemented total hip replacement ( n = @ ) .


The average age of the patients was eighty-four years ( range , seventy-five to @ years ) , and @ % were classified as mentally impaired .


Failure after internal fixation was defined as early redisplacement , nonunion , symptomatic segmental collapse , or deep infection .


In the arthroplasty group , failure was defined as two dislocations or more , implant loosening , deep infection , or a periprosthetic fracture .


For the lucid patients , the failure rate was @ % after internal fixation compared with @ % after total hip replacement .


For patients with mental impairment , it was @ % in both groups .


Total hip replacement is superior to internal fixation in the treatment of a displaced femoral neck fracture .


Ultrasound-guided needle placement is a widely used technical skill that can be challenging to learn .


The SonixGPS is a novel ultrasound needle-tracking system that has the potential to improve performance over traditional ultrasound systems .


The objective of our study was to determine if the use of the SonixGPS ultrasound system improves performance of novice practitioners in ultrasound-guided needle placement compared with conventional ultrasound in the out-of-plane approach on a simulation model .


Twenty-six medical students without previous ultrasound experience were randomized into @ groups .


Each group performed @ simulated ultrasound nerve blocks on a porcine meat tissue simulation ( phantom ) model .


Both groups used the SonixGPS ultrasound ; however , the study group had the needle-tracking system activated , whereas the control group did not .


The participants were assessed for success rate , technical aspects of block performance , and certain behaviors that could compromise the quality of the block .


Learning curves were developed to assess competence .


The needle guidance group reached competence more often .


This group had fewer attempts and quality-compromising behaviors than did those using conventional ultrasound .


Use of the SonixGPS ultrasound needle guidance system improves the performance of technical needling skills of novice trainees in an ex vivo model .


The place of this technology in the wider education of ultrasound-guided regional anesthesia remains to be established .


To compare a comprehensive lifestyle intervention for overweight children performed in groups of families with a conventional single-family treatment .


Two-year follow-up data on anthropometric and psychological outcome are presented .


Overweight and obese children aged @-@years with body mass index ( BMI ) corresponding to @ kg/m ( @ ) in adults were randomised to multiple-family ( n = @ ) or single-family intervention ( n = @ ) in a parallel design .


Multiple-family intervention comprised an inpatient programme with other families and a multidisciplinary team , follow-up visits in their hometown , weekly physical activity and a family camp .


Single-family intervention included counselling by paediatric nurse , paediatric consultant and nutritionist at the hospital and follow-up by a community public health nurse .


Primary outcome measures were change in BMI kg/m ( @ ) and BMI SD score after @years .


BMI increased by @ kg/m ( @ ) in the multiple-family intervention compared with @ kg/m ( @ ) in the single-family intervention ( p = @ ) .


BMI SD score decreased by @ units in the multiple-family group and @ units in the single-family intervention group ( p = @ ) .


A between-group difference of @ cm in waist circumference ( p = @ ) was detected .


Pooled data from both treatment groups showed a significant decrease in BMI SD score of @ units and a significant decrease in parent-reported and self-reported Strength and Difficulty Questionnaire total score of @ units .


Two-year outcome showed no between-group difference in BMI .


A small between-group effect in BMI SD score and waist circumference favouring multiple-family intervention was detected .


Pooled data showed an overall improvement in psychological outcome measures and BMI SD score .


Patients can potentially monitor disease activity of RA through self-assessed swollen joints ( clinical synovitis ) , but reliability is poor .


The objective is to evaluate the use of education by US feedback on the ability of patients to assess for clinical synovitis in RA .


We performed a @ month , single-centre , randomized controlled trial on patients with established RA to study the effect of education on self-assessment of joints that included initial brief patient training on tender ( TJC ) and swollen ( SJC ) joint counts followed by US feedback every @ months vs standard care without education .


Patient and physician independently performed @-joint counts at each visit .


Outcome variables included the percentage of patients with good agreement with physician-derived swollen joints -LSB- prevalence-adjusted bias-adjusted kappa ( PABAK ) > @ -RSB- as well as agreement in the SJC ( Bland and Altman @ % limits of agreement ) , feasibility/patient satisfaction survey and disease activity at @ months .


Of the @ randomized patients , @ were included ( @ in the education arm and @ in the standard care arm ) .


At @ months there was a significant difference in the proportion of patients with swollen joint PABAK > @ in the education arm compared with standard care ( @ vs @ % , P = @ ) .


Limits of agreement for the SJC difference between physician and patients were reduced only in the education arm .


The training method is considered feasible , with @ % of patients reporting it as useful .


A trend of higher rates of disease remission ( @-joint DAS < @ ) in the education arm vs standard care ( @ % vs @ % , P = @ ) was seen .


A short course of education with US feedback may be helpful in educating patients to assess for clinical synovitis .


Transient lower esophageal sphincter relaxation ( TLESR ) is the major mechanism of gastroesophageal reflux ( GER ) but the regulation of TLESR by stimuli in the esophagus is incompletely understood .


If stimuli in the esophagus can influence TLESR , then such regulation may perpetuate or limit GER .


We addressed the hypothesis that acid in the esophagus enhances TLESRs .


We evaluated the effect of acid infusion into the distal esophagus on TLESRs evoked by a standard meal in a paired randomized study in healthy subjects .


TLESRs were evaluated by using high resolution manometry ( HRM ) .


We found that acid in the esophagus enhanced meal-induced TLESRs .


Compared to control infusion the number of TLESRs ( median -LSB- interquartile range -RSB- ) was increased during @h following the acid infusion ( @ -LSB- @-@ -RSB- vs @ -LSB- @-@ -RSB- , p < @ ) .


The average duration of individual TLESRs was not affected .


The time-course analysis revealed that a robust increase in TLESRs occurred already in the first hour when the number of TLESRs nearly doubled ( @ -LSB- @-@ @ -RSB- vs @ -LSB- @-@ @ -RSB- , p < @ ) .


In contrast to the enhancement of TLESRs , the number of swallows was not changed .


The acid infusion into the esophagus increases the number of meal-induced TLESRs in healthy subjects .


Our results provide evidence for the concept that the stimuli in the esophagus can influence TLESRs .


The regulation of TLESR by stimuli in the esophagus may contribute to pathogenesis of GER in some patients .


Previously we conducted a double-blind controlled , randomized efficacy field trial of gD-@ HSV vaccine adjuvanted with ASO@ in @ women .


Subjects had been previously selected to be seronegative for HSV-@ and HSV-@ .


We found that vaccine was @ % protective against HSV-@ genital disease , but offered no significant protection against HSV-@ genital disease .


To better understand the results of the efficacy study , post-vaccination anti-gD-@ antibody concentrations from all HSV infected subjects and matched uninfected controls were measured .


Three models were used to determine whether thes responses correlated with protection against HSV infection or disease .


Similarly , cellular immune responses from a subset of subjects and matched controls were evaluated for a correlation with HSV protection .


Antibodies to gD-@ correlated with protection against HSV-@ infection with higher antibody concentration associated with higher efficacy .


Cellular immune responses to gD-@ did not correlate with protection .


The protection against HSV-@ infection observed in the Herpevac Trial for Women was associated with antibodies directed against the vaccine .


Clinical Trials RegistrationNCT@ .


People with substance use disorders who present with suicidal behavior are at high risk of subsequent suicide .


There are few effective treatments specifically tailored for this population that diminish this risk .


We aimed to assess the impact of an opportunistic cognitive behavioral intervention package ( OCB ) among adult outpatients with a substance use and comorbid suicide risk .


A randomized controlled trial was conducted across @ sites in which @ patients presenting with suicide risk and concurrent substance use received either OCB ( @ sessions plus group therapy ) or treatment as usual ( TAU ) over a @-month period .


Primary outcomes were suicidal behavior ( suicide attempts , suicidal intent and presence of suicide ideation ) and level of drug and alcohol consumption .


Secondary outcomes were changes in psychological measures of suicide ideation , depression , anxiety , and self-efficacy .


There were no completed suicides , and only @ participants reported suicide attempts at follow-up .


Suicide ideation , alcohol consumption , and cannabis use fell over time but no significant Treatment Time differences were found .


There were also no differences between OCB and TAU over time on psychological measures of depression , anxiety , or self-efficacy .


Suicide ideation at @-month follow-up was predicted by cannabis use and higher scores on the Brief Psychiatric Rating Scale at baseline .


The opportunistic cognitive behavioral intervention package did not appear to be beneficial in reducing suicide ideation , drug and alcohol consumption , or depression relative to treatment as usual .


To compare bariatric surgery versus intensive medical weight management ( MWM ) in patients with type @ diabetes mellitus ( T@DM ) who do not meet current National Institutes of Health criteria for bariatric surgery and to assess whether the soluble form of receptor for advanced glycation end products ( sRAGE ) is a biomarker to identify patients most likely to benefit from surgery .


There are few studies comparing surgery to MWM for patients with T@DM and BMI less than @ .


Fifty-seven patients with T@DM and BMI @ to @ , who otherwise met the criteria for bariatric surgery were randomized to MWM versus surgery ( bypass , sleeve or band , based on patient preference ) .


The primary outcomes assessed at @ months were change in homeostatic model of insulin resistance ( HOMA-IR ) and diabetes remission .


Secondary outcomes included changes in HbA@c , weight , and sRAGE .


The surgery group had improved HOMA-IR ( -@ vs +@ ; P = @ ) and higher diabetes remission ( @ % vs @ % , P < @ ) than the MWM group at @ months .


Compared to MWM , the surgery group had lower HbA@c ( @ vs @ , P = @ ) , lower fasting glucose ( @ vs @ ; P = @ ) , and fewer T@DM medication requirements ( @ % vs @ % ; P < @ ) at @ months .


The surgery group lost more weight ( @ .


vs @ BMI decrease , P < @ ) .


Higher baseline sRAGE was associated with better weight loss outcomes ( r = -@ ; P = @ ) .


There were no mortalities .


Surgery was very effective short-term in patients with T@DM and BMI @ to @ .


Baseline sRAGE may predict patients most likely to benefit from surgery .


These findings need to be confirmed with larger studies.ClinicalTrials.gov ID : NCT@ .


Susceptibility to encapsulated bacteria is well known in sickle cell disease ( SCD ) .


Hydroxyurea use is common in adults and children with SCD , but little is known about hydroxyurea 's effects on immune function in SCD .


Because hydroxyurea inhibits ribonucleotide reductase , causing cell cycle arrest at the G@-S interface , we postulated that hydroxyurea might delay transition from naive to memory T cells , with inhibition of immunologic maturation and vaccine responses .


T-cell subsets , naive and memory T cells , and antibody responses to pneumococcal and measles , mumps , and rubella vaccines were measured among participants in a multicenter , randomized , double-blind , placebo-controlled trial of hydroxyurea in infants and young children with SCD ( BABY HUG ) .


Compared with placebo , hydroxyurea treatment resulted in significantly lower total lymphocyte , CD@ , and memory T-cell counts ; however , these numbers were still within the range of historical healthy controls .


Antibody responses to pneumococcal vaccination were not affected , but a delay in achieving protective measles antibody levels occurred in the hydroxyurea group .


Antibody levels to measles , mumps , and rubella showed no differences between groups at exit , indicating that effective immunization can be achieved despite hydroxyurea use .


Hydroxyurea does not appear to have significant deleterious effects on the immune function of infants and children with SCD .


Additional assessments of lymphocyte parameters of hydroxyurea-treated children may be warranted .


No changes in current immunization schedules are recommended ; however , for endemic disease or epidemics , adherence to accelerated immunization schedules for the measles , mumps , and rubella vaccine should be reinforced .


To evaluate acupuncture as treatment for glaucoma .


Prospective double-masked randomized crossover study .


setting : Clinical practice .


One eye per patient with primary open-angle glaucoma and stable intraocular pressure ( IOP ) .


Patients were randomized to receive @ acupuncture series ( @ sessions with either eye-related -LSB- eye-points -RSB- or non-eye-related -LSB- non-eye-points -RSB- acupoints ) and then crossed over to receive the other series .


IOP , blood pressure ( BP ) , heart rate ( HR ) , best-corrected visual acuity ( BCVA ) , visual field ( VF ) , optic disc and peripapillary retinal nerve fiber layer ( RNFL ) measurements , compliance , and adverse reactions .


Probability to detect @ mm Hg IOP difference between series was @ % .


Twenty-two patients volunteered and @ ( @ % ) completed the study ; @ ( @ % ) did not complete treatment owing to changes of health , moving away , lack of transportation , or family crisis ; and @ ( @ % ) were withdrawn owing to needle sensitivity or IOP elevation ( @ mm Hg ) in the contralateral eye .


After an acupuncture session , mean IOP increased slightly with both eye-points ( from @ @ mm Hg to @ @ mm Hg , P = @ ) and non-eye-points ( from @ @ mm Hg to @ @ mm Hg , P = @ ) series .


HR , diurnal IOP , and BCVA showed no statistically significant changes after @ sessions of either series .


Systolic and diastolic BP were reduced after @ sessions of non-eye-points series ( P = @ , P = @ , respectively ) .


Optic disc , RNFL , and VF showed no statistically significant changes .


Acupuncture has no overall effect on diurnal IOP or BCVA but may temporally increase the IOP immediately after a treatment session .


BP is lowered by acupuncture with non-eye-points , but not with eye-points .


Compliance and adverse event rates were low .


Scarce data are available on the effect of the traditional Mediterranean diet ( TMD ) on heart failure biomarkers .


We assessed the effect of TMD on biomarkers related to heart failure in a high cardiovascular disease risk population .


A total of @ subjects at high cardiovascular risk ( @ men and @ women ) were recruited in the framework of a multicentre , randomized , controlled , parallel-group clinical trial directed at testing the efficacy of the TMD on the primary prevention of cardiovascular disease ( The PREDIMED Study ) .


Participants were assigned to a low-fat diet ( control , n = @ ) or one of two TMDs -LSB- TMD + virgin olive oil ( VOO ) or TMD + nuts -RSB- .


Depending on group assignment , participants received free provision of extra-virgin olive oil , mixed nuts , or small non-food gifts .


After @year of intervention , both TMDs decreased plasma N-terminal pro-brain natriuretic peptide , with changes reaching significance vs. control group ( P < @ ) .


Oxidized low-density lipoprotein decreased in both TMD groups ( P < @ ) , the decrease in TMD+VOO group reaching significance vs. changes in control group ( P = @ ) .


Changes in lipoprotein ( a ) after TMD+VOO were less than those in the control group ( P = @ ) in which an increase ( P = @ ) was observed .


No changes were observed in urinary albumin or albumin/creatinine ratio .


Individuals at high risk of cardiovascular disease ( CVD ) who improved their diet toward a TMD pattern reduced their N-terminal pro-brain natriuretic peptide compared with those assigned to a low-fat diet .


The same was found for in vivo oxidized low-density lipoprotein and lipoprotein ( a ) plasma concentrations after the TMD+VOO diet .


From our results TMD could be a useful tool to mitigate against risk factors for heart failure .


From our results TMD could modify markers of heart failure towards a more protective mode .


Previous qualitative research among adults and parents of children with phenylketonuria ( PKU ) has identified inattention as an important psychiatric aspect of this condition .


The parent-reported ADHD Rating Scale-IV ( ADHD RS-IV ) and the Adult ADHD Self-Report Scale ( ASRS ) have been validated for measuring inattention symptoms in persons with attention-deficit/hyperactivity disorder ( ADHD ) ; however , their psychometric attributes for measuring PKU-related inattention have not been established .


The primary objective of this investigation was to demonstrate the reliability , validity , and responsiveness of the ADHD RS-IV and ASRS inattention symptoms subscales in a randomized controlled trial of patients with PKU aged @ years or older .


A post hoc analysis investigated the psychometric properties ( Rasch model fit , reliability , construct validity , and responsiveness ) of the ADHD RS-IV and ASRS inattention subscales using data from a phase @b , double-blind , placebo-controlled clinical trial in those with PKU aged @ years or older .


The Rasch results revealed good model fit , and reliability analyses revealed strong internal consistency reliability ( @ ) and reproducibility ( intraclass correlation coefficient @ ) for both measures .


Both inattention measures demonstrated the ability to discriminate between known groups ( P < @ ) created by the Clinical Global Impression-Severity scale .


Correlations between the ADHD RS-IV and the ASRS with the Clinical Global Impression-Severity scale and the age-appropriate Behavior Rating Inventory of Executive Function Working Memory subscale were consistently moderate to strong ( r @ ) .


Similarly , results of the change score correlations were of moderate magnitude ( r @ ) for both measures when compared with changes over time in Behavior Rating Inventory of Executive Function Working Memory subscales .


These findings of reliability , validity , and responsiveness of both the ADHD RS-IV and the ASRS inattention scales , in addition to content validation results , support their use for the assessment of inattention symptoms among persons with PKU aged @ years or older in both clinical and research settings .


To evaluate the relationship between lipid content and plaque morphometry as well as the process of lesion progression and regression in patients with significant coronary artery disease .


The present study , using data from the YELLOW trial , was conducted in patients having significant coronary lesions ( fractional flow reserve < @ ) who underwent serial intravascular ultrasound ( IVUS ) and near-infrared spectroscopy ( NIRS ) at baseline and after @ weeks .


For each coronary plaque ( @ % plaque burden that was @ mm in length ) , we evaluated plaque characteristics and the extent of lipid-rich plaque -LSB- LRP , defined as the @ mm long segment with the maximum lipid-core burden index ( maxLCBI@ mm ) -RSB- on NIRS .


Among @ patients ( age @ @ years ; @ % statin use at baseline ) , @ plaques were identified .


The extent of LRP at baseline was positively correlated with IVUS plaque burden ( r = @ , P = @ ) .


A large LRP ( maxLCBI@ mm @ ) was present only in plaques with a large plaque burden ( @ % ) .


Multivariate analysis demonstrated that plaque burden was the best predictor of the extent of LRP ( P < @ ) .


In lesions with a large plaque burden and a large amount of LRP at baseline , a reduction in LRP was seen in all lesions in patients receiving intensive statin therapy ( P = @ ) without a significant change in plaque burden .


Coronary lesions containing a large amount of LRP also had a large plaque burden .


Short-term regression of LRP ( without a change in plaque burden ) was observed mainly in plaques with a large plaque burden and a large amount of LRP at baseline .


High blood pressure is common in acute stroke and associated with a worse functional outcome .


Many patients who present with acute stroke are taking prescribed antihypertensive therapy before their stroke .


ENOS tested whether lowering blood pressure and continuing pre-stroke antihypertensive therapy are each safe and effective .


This study is an international multi-centre prospective randomized single-blind blinded-endpoint parallel-group partial-factorial controlled trial of transdermal glyceryl trinitrate ( a nitric oxide donor , given for seven-days ) vs. no glyceryl trinitrate , and of continuing vs. stopping ( temporarily for seven-days ) pre-stroke antihypertensive drugs if relevant , inpatients with acute ischaemic stroke or intracerebral haemorrhage and high systolic blood pressure ( @ mmHg ) .


Recruitment ran from July @ to October @ .


Four thousand eleven patients -LSB- @ ( @ % ) in the continue/stop arm -RSB- were recruited from @ sites across @ countries in @ continents ( Asia @ % , Continental Europe @ % , UK @ % ) .


Baseline characteristics include : mean age @ ( standard deviation @ ) years ; male @ % ; mean time from stroke to recruitment @ ( @ ) h ; mean severity ( Scandinavian Stroke Scale ) @ ( @ ) of @ ; mean blood pressure @ ( @ ) / @ ( @ ) mmHg ; ischaemic stroke @ % ; and intracerebral haemorrhage @ % .


The main trial results will be presented in May @ .


The results will also be presented in updated Cochrane systematic reviews and included in individual patient data meta-analyses of all relevant randomized controlled trials .


ENOS is a large completed international trial of blood pressure management in acute stroke and includes patients representative of many stroke services worldwide .


To assess the role of pelvic plexus block ( PPB ) in reducing pain during transrectal ultrasonography ( TRUS ) - guided prostate biopsy , compared with the conventional periprostatic nerve block ( PNB ) .


A prospective , double-blind observational study was conducted with patients being randomised into three groups .


Group-@ ( @ patients ) received intrarectal local anaesthesia ( IRLA ) with @ mL @ % lignocaine jelly along with pelvic plexus block ( PPB ) with @ mL @ % lignocaine injection bilaterally .


Group-@ ( @ patients ) received IRLA with periprostatic nerve block ( PNB ) .


Group-@ ( @ patients ) received only IRLA without any type of nerve block .


The patients were requested to rate the level of pain from @ to @ on a visual analogue scale ( VAS ) at two time points : VAS-@ : during biopsy procedure and VAS-@ : @ min after the procedure .


The mean age of the patients , mean volume of the prostates and mean serum PSA values were comparable among the three groups .


The mean pain score during biopsy was significantly less in the PPB group -LSB- mean ( range ) sore of @ ( @-@ ) -RSB- compared with the PNB group -LSB- mean ( range ) score of @ ( @-@ ) -RSB- , and both these groups were superior to the no nerve block group -LSB- mean score of @ ( @-@ ) -RSB- .


There was no significant difference between the mean pain scores , @ min after the procedure among the three groups with the mean ( range ) scores being @ ( @-@ ) , @ ( @-@ ) and @ ( @-@ ) , respectively .


PPB is superior to conventional periprostatic nerve block ( PNB ) for pain control during TRUS-guided biopsy and both are in turn superior to no nerve block .


To study the effects of four different rigid alignment approaches on both time-concentration curves ( TCCs ) and perfusion maps in computed tomography perfusion ( CTp ) studies of liver and lung tumors .


Eleven data sets in patients who were subjected to axial CTp after contrast agent administration were assessed .


Each data set consists of four different sequences , according to the different rigid alignment configurations considered to compute blood flow perfusion maps : no alignment , translational , craniocaudal , and three dimensional ( @D ) .


The color maps were built on TCCs according to the maximum slope method .


The effects of motion correction procedures on the reliability of TCCs and perfusion maps were assessed both quantitatively and visually .


TCCs built after @D alignments show the best indices as well as producing the most reliable maps .


We show examinations in which the translational alignment only yields more accurate TCCs , but less reliable perfusion maps , than those achieved with no alignment .


Furthermore , we show color maps with two different perfusion patterns , both considered reliable by radiologists , achieved with different motion correction approaches .


The quantitative index we conceived allows relating quality of @D alignment and reliability of perfusion maps .


A better alignment does not necessarily yield more reliable perfusion values : color maps resulting from either alignment procedure must be critically assessed by radiologists .


This achievement will hopefully represent a step forward for the clinical use of CTp studies for staging , prognosis , and monitoring values of therapeutic regimens .


The purpose of this study was to explore the effectiveness and safety of three-dimensional ( @D ) digitalized planning for the sural neurovascular island flap in repair of soft tissue defects in the ankle and foot .


This study included @ patients with soft tissue defects of the ankle and foot who underwent soft tissue reconstruction between October @ and June @ .


The patients were randomly assigned into two groups : @D-reconstruction group ( Group A , n = @ ) and control group ( Group B , n = @ ) .


Three-dimensional , digitalized virtual planning was performed in the patients in Group A , who underwent computed topographic angiography .


The survival rate , operation time , and surgical accuracy were compared between the two groups .


All flaps in Group A survived and the recipient site primarily healed , but @ flaps in Group B had marginal necrosis after the operation .


During the @-@ month follow-up period , all flaps in Group A had good skin quality .


In Group B , hard scarring and mild contracture occurred in @ cases , and the patients experienced pain when walking .


The survival rate of the flap in Group A ( @ % ) was significantly higher than in Group B ( @ % ) .


The operation time in Group A was significantly less than in Group B.


The surgical accuracy in Group A was significantly better than in Group B.


The preoperative use of @D digitalized virtual planning for the sural neurovascular island flap improves the surgical accuracy , decreases the operation time , and increases the survival rate of the flap .


Therapeutic III .


To evaluate clinical remission with subcutaneous abatacept plus methotrexate ( MTX ) and abatacept monotherapy at @months in patients with early rheumatoid arthritis ( RA ) , and maintenance of remission following the rapid withdrawal of all RA treatment .


In the Assessing Very Early Rheumatoid arthritis Treatment phase @b trial , patients with early active RA were randomised to double-blind , weekly , subcutaneous abatacept @mg plus MTX , abatacept @mg monotherapy , or MTX for @months .


Patients with low disease activity ( Disease Activity Score ( DAS ) @ ( C reactive protein ( CRP ) ) < @ ) at month @ entered a @-month period of withdrawal of all RA therapy .


The coprimary endpoints were the proportion of patients with DAS@ ( CRP ) < @ at month @ and both months @ and @ , for abatacept plus MTX versus MTX .


Patients had < @years of RA symptoms , DAS@ ( CRP ) @ , anticitrullinated peptide-@ antibody positivity and @ % were rheumatoid factor positive .


For abatacept plus MTX versus MTX , DAS@ ( CRP ) < @ was achieved in @ % versus @ % ( p = @ ) at @months , and following treatment withdrawal , in @ % versus @ % ( p = @ ) at both @ and @months .


DAS@ ( CRP ) < @ was achieved for abatacept monotherapy in @ % ( month @ ) and @ % ( both months @ and @ ) .


Both abatacept arms had a safety profile comparable with MTX alone .


Abatacept plus MTX demonstrated robust efficacy compared with MTX alone in early RA , with a good safety profile .


The achievement of sustained remission following withdrawal of all RA therapy suggests an effect of abatacept 's mechanism on autoimmune processes .


Sealing of the femoral canal , usually with autologous bone , is a surgical procedure that is often performed during TKA surgery to decrease blood loss in the postoperative period .


However , evidence as to the effectiveness of this surgical procedure is not conclusive .


The objective of this study was to assess the effectiveness of this surgical action in reducing postoperative blood loss and the blood transfusion rate .


A randomized prospective study that included @ TKAs divided into three groups ( @ in each one ) was carried out .


The three groups were ; A ) bone graft sealing , B ) cement sealing and C ) unsealed canal .


All groups were comparable with regard to pre and intra-operative data .


The haemoglobin decrease at @ , @ and @ h was compared to the preoperative haemoglobin value .


Subsequently , blood drainage at @ and @h and the rate of blood transfusion were also assessed .


The different complications that arose were reported .


No statistical differences were obtained with regard to blood drainage at @h ( p = @ ) and @h ( p = @ ) , the haemoglobin value decrease at @ h ( p = @ ) and the number of blood transfusions ( p = @ ) in the three groups studied .


There was no significant difference , whether sealing the femoral canal with a bone graft , cement or when it was left unsealed , in decreasing blood loss or blood transfusion requirements in the postoperative period .


Therapeutic type I.


To observe the clinical efficacy and safety of electroacupuncture ( EA ) combined with herbal acupoint sticking in the treatment of Bell 's palsy and provide optimizations for the clinic .


One hundred and two cases of Bell 's palsy were randomized into an EA combined with herbal acupoint sticking group ( group A , @ cases ) and an EA group ( group B , @ cases ) , EA at Cuanzhu ( BL @ ) , Yangbai ( GB @ ) , Taiyang ( EX-HN @ ) , Quanliao ( SI @ ) , Xiaguan ( ST @ ) , Yingxiang ( LI @ ) , etc. were applied in both groups and `` facial paralys No.I '' was applied at Yifeng ( TE @ ) in group A , once daily and @ times totally were needed .


The score of facial nerve function , clinical efficacy were compared before and after treatment .


At @ and @ month follow up visit , the quality of life scale ( WHOQOL-BREF ) and the occurrence of complication were observed .


The scores of facial nerve function in group A and group B were all significantly improved compared with those before treatment ( @ + / - @ vs @ + / - @ , @ + / - @ vs @ + / - @ , both P < O. @ ) , the cured rate in group A -LSB- @ % ( @/@ ) -RSB- were significantly superior to that in group B -LSB- @ % ( @/@ ) -RSB- ( P < @ ) ; the difference of WHOQOL-BREF in both groups at @ and @ month follow up visit was not significant ( all P > @ ) .


The occurrence of complication in group A ( @ case ) was significantly less than that in group B ( @ cases , P @ ) .


Compared with EA , the combination of EA and acupoint sticking therapy for Bell 's palsy can not only improve the clinical efficacy and reduce the occurrence of complication but also reliable without any side effect .


The combination of dutasteride and tamsulosin may be more effective for the treatment of symptomatic benign prostatic hyperplasia than either treatment alone .


We report the results of three pharmacokinetics and tolerability studies , which used a dutasteride/tamsulosin HCl ( @ mg/@ @ mg ) fixed-dose combination ( FDC ) capsules containing a small dutasteride soft gelatin capsule ( smaller than commercial Avodart ) and modified-release tamsulosin pellets that have different amounts of enteric coating .


These studies compared the test products to commercial Avodart ( dutasteride @ mg ) and two different commercial tamsulosin HCl @ mg products , Harnal Capsules or Harnal-D Tablets , which are reportedly bioequivalent to each other .


All three studies were randomized single-dose studies in healthy male adults .


Study @ -LSB- N = @ ( NCT@ ) -RSB- was a two-period crossover study of a dutasteride/tamsulosin HCl FDC versus coadministered Avodart and Harnal-D Tablets .


The pharmacokinetics of both dutasteride and tamsulosin were studied .


Study @ -LSB- N = @ ( NCT@ ) -RSB- was a four-period crossover study of dutasteride/tamsulosin HCl FDC formulations versus Avodart and Harnal Capsules or Harnal-D Tablets .


Only the pharmacokinetics of tamsulosin were studied .


Study @ -LSB- N = @ ( NCT@ ) -RSB- was a two-period study of dutasteride/tamsulosin HCl FDC formulations versus coadministered Avodart and Harnal-D Tablets .


In this study , only the pharmacokinetics of tamsulosin were studied .


Study @ assessed fed-state pharmacokinetics .


Studies @ and @ assessed fed - and fasted-state pharmacokinetics .


All dutasteride/tamsulosin HCl FDC formulations and coadministered treatments were well-tolerated .


In Study@ , the FDC dutasteride was bioequivalent to Avodart coadministered with tamsulosin under fed and fasted conditions .


In Study@ , the FDC tamsulosin had a slower release than commercial Harnal-D Tablets coadministered with dutasteride ( fed and fasted state ) .


In Study@ , the FDC tamsulosin containing @ % by weight enteric-coated tamsulosin pellets was bioequivalent to Harnal Capsules coadministered with dutasteride in the fed state .


In Study@ , the FDC containing @ % by weight enteric-coated tamsulosin pellets combined with uncoated tamsulosin pellets ( coated : uncoated = @:@ ) were bioequivalent to Harnal-D Tablets coadministered with dutasteride in the fasted state but not the fed state .


The FDC formulations were well-tolerated and some FDC formulations were comparable with concomitant administration of commercially available dutasteride and tamsulosin .


GastroGard , an omeprazole powder paste formulation , is considered the standard treatment for gastric ulcers in horses and is highly effective .


Gastrozol , an enteric-coated omeprazole formulation for horses , has recently become available , but efficacy data are controversial and sparse .


To investigate the efficacy of GastroGard and Gastrozol at labeled doses ( @ and @ mg of omeprazole per kg bwt , respectively , PO q@h ) in healing of gastric ulcers .


@ horses ; @ @ years ; @ @ kg .


Prospective , randomized , blinded study .


Horses with an ulcer score @ ( Equine Gastric Ulcer Council ) were randomly divided into @ groups and treated for @ weeks each with GastroGard followed by Gastrozol ( A ) or vice versa ( B ) .


After @ and @ weeks , scoring was repeated and compared with baseline .


Plasma omeprazole concentrations were measured on the first day of treatment after administration of GastroGard ( n = @ ) or Gastrozol ( n = @ ) .


Compared with baseline ( squamous score ( A ) @ @ , ( B ) @ @ ) , ulcer scores at @ weeks ( ( A ) @ @ , ( B ) @ @ ) and @ weeks ( ( A ) @ @ , ( B ) @ @ ) had significantly decreased in both groups ( P < @ ) , independent of treatment ( P = @ ) .


Plasma omeprazole concentrations were significantly higher after GastroGard compared with Gastrozol administration ( AUCGG = @ ( @-@ ) ng/mL h , AUCGZ = @ ( @-@ ) ng/mL h ; P = @ ) .


The bioavailability for Gastrozol was @ ( @ % CI @-@ @ ) times higher than for GastroGard .


Both Gastrozol and GastroGard , combined with appropriate environmental changes , promote healing of gastric ulcers in horses .


However , despite enteric coating of Gastrozol , plasma omeprazole concentrations after single labeled doses were significantly higher with GastroGard .


There is a need for the accurate assessment of circadian phase outside of the clinic/laboratory , particularly with the gold standard dim light melatonin onset ( DLMO ) .


We tested a novel kit designed to assist in saliva sampling at home for later determination of the DLMO .


The home kit includes objective measures of compliance to the requirements for dim light and half-hourly saliva sampling .


Participants were randomized to one of two @-day protocols .


Each protocol consisted of two back-to-back home and laboratory phase assessments in counterbalanced order , separated by a @-day break .


Laboratory or participants ' homes .


Thirty-five healthy adults , age @-@ y.


N/A .


Most participants received at least one @-sec epoch of light > @ lux during the home phase assessments ( average light intensity @ lux ) , but on average for < @ min of the required @ h. Most participants collected every saliva sample within @ min of the scheduled time .


Ninety-two percent of home DLMOs were not affected by light > @ lux or sampling errors .


There was no significant difference between the home and laboratory DLMOs ( P > @ ) ; on average the home DLMOs occurred @ min before the laboratory DLMOs .


The home DLMOs were highly correlated with the laboratory DLMOs ( r = @ , P < @ ) .


Participants were reasonably compliant to the home phase assessment procedures .


The good agreement between the home and laboratory dim light melatonin onsets ( DLMOs ) demonstrates that including objective measures of light exposure and sample timing during home saliva sampling can lead to accurate home DLMOs .


Both short wavelength ( blue ) light and caffeine have been studied for their mood enhancing effects on humans .


The ability of blue light to increase alertness , mood and cognitive function via non-image forming neuropathways has been suggested as a non-pharmacological countermeasure for depression across a range of occupational settings .


This experimental study compared blue light and caffeine and aimed to test the effects of blue light/placebo ( BLU ) , white light/@-mg caffeine ( CAF ) , blue light/@-mg caffeine ( BCAF ) and white light/placebo ( PLA ) , on mood .


A randomised , controlled , crossover design study was used , in a convenience population of @ healthy volunteers .


The participants rated their mood on the Swedish Core Affect Scales ( SCAS ) prior to and after each experimental condition to assess the dimensions of valence and activation .


There was a significant main effect of light ( p = @ ) , and the combination of blue light and caffeine had clear positive effects on core effects ( ES , ranging from @ to @ ) and global mood ( ES , @ ) .


The benefits of the combination of blue light and caffeine should be further investigated across a range of applications due to the observed effects on the dimensions of arousal , valence and pleasant activation .


To evaluate the efficacy of the five ear acupuncture points ( Shen-men , Spleen , Stomach , Hunger , Endocrine ) , generally used in Korean clinics for treating obesity , and compare them with the Hunger acupuncture point .


A randomised controlled clinical trial was conducted in @ Koreans ( @ male and @ female , body mass index ( BMI ) @ ) , who had not received any other weight control treatment within the past @ months .


Subjects were divided randomly into treatment I , treatment II or sham control groups and received unilateral auricular acupuncture with indwelling needles replaced weekly for @ weeks .


Treatment I group received acupuncture at the five ear acupuncture points , treatment II group at the Hunger acupuncture point only and the sham control group received acupuncture at the five ear acupuncture points used in treatment I , but the needles were removed immediately after insertion .


BMI , waist circumference , weight , body fat mass ( BFM ) , percentage body fat and blood pressure were measured at baseline and at @ and @ weeks after treatment .


For the @ participants who provided data at @ weeks , significant differences in BMI , weight and BFM were found between the treatment and control groups .


Treatment groups I and II showed @ % and @ % reduction in BMI , respectively ( p < @ ) .


There were no significant differences between the two treatment groups .


This finding suggests that the five ear acupuncture points , generally used in Korean clinics , and the Hunger point alone treatment are both effective for treating overweight people .


There are limited data regarding factors associated with spontaneous left ventricular reverse remodeling ( S-LVRR ) among mildly symptomatic heart failure ( HF ) patients and its prognostic implications on clinical outcomes .


Best subsets logistic regression analysis was used to identify factors associated with S-LVRR ( defined as @ % reduction in left ventricular end-systolic volume at @-year of follow-up ) among @ patients treated with internal cardioverter defibrillator-only therapy in Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy ( MADIT-CRT ) and to create a score for the prediction of S-LVRR .


Cox proportional hazards regression modeling was used to assess the clinical outcome of all internal cardioverter defibrillator-only patients ( n = @ ) with a high S-LVRR score .


S-LVRR occurred in @ % of internal cardioverter defibrillator-only patients .


Predictors of S-LVRR included systolic blood pressure@ mm Hg , serum creatinine < @ mg/dL , QRS @ to @ ms , and nonischemic cardiomyopathy .


Multivariate analysis showed that each @-point increment in S-LVRR score ( range , @-@ ) was associated with an @ % ( P = @ ) reduction in the risk of HF or death .


Treatment with cardiac resynchronization therapy was associated with a significant reduction in the risk of HF or death only among internal cardioverter defibrillator-treated patients with a low ( Q@-@ ) S-LVRR score ( hazard ratio = @ ; P < @ ) , but not among those with a higher ( Q@ ) score ( hazard ratio = @ ; P = @ ) .


Our data suggest that approximately one quarter of mild HF patients eligible for biventricular pacing experience S-LVRR .


Combined assessment of clinical factors associated with S-LVRR can be used to identify mild HF patients with a low risk for clinical events without cardiac resynchronization therapy intervention .


Early injection of atropine during dobutamine stress echocardiography ( DSE ) has been demonstrated in retrospective analyses to reduce the duration and dose of dobutamine infusion , while preserving a similar diagnostic accuracy with a lower incidence of adverse effects .


This study explores the safety of using atropine as a start drug before dobutamine infusion ( ADSE protocol ) in comparison with the conventional protocol ( DASE protocol ) in older patients undergoing DSE for ischemia evaluation .


One hundred consecutive older patients were prospectively enrolled .


When eligible , they were randomly assigned to undergo either the DASE protocol ( group A , @ patients ) or the ADSE protocol ( group B , @ patients ) when atropine ( @ mg ) was first administered @ min before dobutamine infusion followed by @ mg increments ( maximum @ mg ) thereafter .


Patients were monitored for adverse drug effects .


Test duration was calculated .


The mean age of the whole study cohort was @ years and @ ( @ % ) were men .


Patients in group A had longer test duration ( @ versus @ min , p < @ ) and higher mean dobutamine infusion rate ( @ versus @ g/kg/min , p < @ ) .


The two groups received a similar total dose of atropine .


Group A patients showed significantly higher incidence of extrasystoles , nonsustained ventricular tachycardia and severe hypotension ( p < @ ) .


In older patients undergoing DSE , using atropine as a start drug , that is , adopting the ADSE protocol , is associated with shorter test duration , lower mean dobutamine infusion rate and consequently fewer adverse effects .


Headaches are a common medical problem , yet few studies , particularly trials , have evaluated therapies that might prevent or control headaches .