Efficacy , cosmetic outcome and patients ' overall satisfaction with MAL-PDT are superior in comparison with DHA .


MAL-PDT is more expensive but it is more cost-effective .


Iron deficiency anaemia ( IDA ) is a common nutritional problem .


To determine the effect of nutritional education and supplemental iron administration on the prevalence of IDA in Arab infants .


Three hundred and ten infants were randomized alternately into two groups .


Mothers ( n = 143 ) in the control group received standard information on prevention of IDA and mothers in the intervention group ( n = 144 ) received extensive information on the importance of an iron-rich diet .


Data was scored regarding diet contents .


Mothers in the intervention group were encouraged to give their children an iron polymaltose complex ( IPC ) preparation starting from age 4 months to 1 year .


Compliance of receiving the medication was evaluated .


The groups were compared for outcome by chi-square test .


Main outcome measures were haemoglobin ( Hb ) , mean corpuscular volume ( MCV ) , and serum ferritin levels .


Anaemia ( Hb < 11 g/dL ) was recorded in 28 % and 34 % of the intervention and control groups , respectively ( p = NS ) .


There was no effect of infant or parental background factors on rate of anaemia .


Frequency of anaemia was lower in infants who received 6 months of iron medication according to mothers ' reports , and in infants breastfed for 6 months ( p = 0.002 ) .


Questions were raised regarding the strategies of preventing IDA in infancy .


Few studies have measured the ability of interventions to affect declining - cell function in screen-detected type 2 diabetes .


The Early Diabetes Intervention Programme ( ClinicalTrials.gov NCT01470937 ) was a randomized study based on the hypothesis that improving postprandial glucose excursions with acarbose would slow the progression of fasting hyperglycaemia in screen-detected type 2 diabetes .


In the Early Diabetes Intervention Programme , the effect of acarbose plus lifestyle advice on progression of fasting hyperglycaemia over a 5-year period was not greater than that of placebo .


However , there was an early glucose-lowering effect of the trial .


The objective of the current secondary analysis was to describe - cell function changes in response to glucose lowering .


Participants were overweight adult subjects with screen-detected type 2 diabetes .


- cell function was measured using hyperglycaemic clamps and oral glucose tolerance testing .


The primary outcome was the change in - cell function from baseline to year 1 , the time point where the maximal glucose-lowering effect was seen .


At baseline , participants exhibited markedly impaired first-phase insulin response .


Despite significant reductions in weight , fasting plasma glucose ( PG ) and 2-h PG , there was no clinically significant improvement in the first-phase insulin response .


Late-phase insulin responses declined despite beneficial glycaemic effects of interventions .


Insulin secretion is already severely impaired in early , screen-detected type 2 diabetes .


Effective glucose-lowering intervention with acarbose was not sufficient to improve insulin secretion or halt the decline of - cell function .


Uncomplicated acute type B aortic dissection ( AD ) treated conservatively has a 10 % 30-day mortality and up to 25 % need intervention within 4 years .


In complicated AD , stent grafts have been encouraging .


The aim of the present prospective randomised trial was to compare best medical treatment ( BMT ) with BMT and Gore TAG stent graft in patients with uncomplicated AD .


The primary endpoint was a combination of incomplete/no false lumen thrombosis , aortic dilatation , or aortic rupture at 1 year .


The AD history had to be less than 14 days , and exclusion criteria were rupture , impending rupture , malperfusion .


Of the 61 patients randomised , 80 % were DeBakey type IIIB .


Thirty-one patients were randomised to the BMT group and 30 to the BMT+TAG group .


Mean age was 63 years for both groups .


The left subclavian artery was completely covered in 47 % and in part in 17 % of the cases .


During the first 30 days , no deaths occurred in either group , but there were three crossovers from the BMT to the BMT+TAG group , all due to progression of disease within 1 week .


There were two withdrawals from the BMT+TAG group .


At the 1-year follow up there had been another two failures in the BMT group : one malperfusion and one aneurysm formation ( p = .056 for all ) .


One death occurred in the BMT+TAG group .


For the overall endpoint BMT+TAG was significantly different from BMT only ( p < .001 ) .


Incomplete false lumen thrombosis , was found in 13 ( 43 % ) of the TAG+BMT group and 30 ( 97 % ) of the BMT group ( p < .001 ) .


The false lumen reduced in size in the BMT+TAG group ( p < .001 ) whereas in the BMT group it increased .


The true lumen increased in the BMT+TAG ( p < .001 ) whereas in the BMT group it remained unchanged .


The overall transverse diameter was the same at the beginning and after 1 year in the BMT group ( 42.1 mm ) , but in the BMT+TAG it decreased ( 38.8 mm ; p = .062 ) .


Uncomplicated AD can be safely treated with the Gore TAG device .


Remodelling with thrombosis of the false lumen and reduction of its diameter is induced by the stent graft , but long term results are needed .


Despite the established benefits of exercise for adults with arthritis , participation is low .


Safe , evidence-based , self-directed programs , which have the potential for high reach at a low cost , are needed .


To test a 12-week , self-directed , multicomponent exercise program for adults with arthritis .


Randomized controlled trial .


Data were collected from 2010 to 2012 .


Data were analyzed in 2013 and 2014 .


Adults with arthritis ( N = 401 , aged 56.3 [ 10.7 ] years , 85.8 % women , 63.8 % white , 35.2 % African American , BMI of 33.0 [ 8.2 ] ) completed measures at a university research center and participated in a self-directed exercise intervention ( First Step to Active Health ( ) ) or nutrition control program ( Steps to Healthy Eating ) .


Intervention participants received a self-directed multicomponent exercise program and returned self-monitoring logs for 12 weeks .


Self-reported physical activity , functional performance measures , and disease-specific outcomes ( arthritis symptoms and self-efficacy ) assessed at baseline , 12 weeks , and 9 months .


Participants in the exercise condition showed greater increases in physical activity than those in the nutrition control group ( p = 0.01 ) .


Significant improvements , irrespective of condition , were seen in lower body strength , functional exercise capacity , lower body flexibility , pain , fatigue , stiffness , and arthritis management self-efficacy ( p values < 0.0001 ) .


More adverse events occurred in the exercise than nutrition control condition , but only one was severe and most were expected with increased physical activity .


The exercise program improves physical activity , and both programs improve functional and psychosocial outcomes .


Potential reasons for improvements in the nutrition control condition are discussed .


These interventions have the potential for large-scale dissemination .


This study is registered at Clinicaltrials.gov NCT01172327 .


We have recently demonstrated short-term ( 6-month ) efficacy and safety of leuprolide acetate 3-month depot 11.25 and 30 mg in children with central precocious puberty ( CPP ) .


To assess long-term ( 36-month ) hypothalamic-pituitary-gonadal axis suppression and safety of leuprolide acetate 3-month depot 11.25 and 30 mg in children with CPP .


Open-label , 36-month extension .


Twenty pediatric endocrine centers .


Seventy-two children ( mean age , 8.5 1.6 y ; 65 females ) with CPP completed and showed maintenance of LH suppression after a 6-month lead-in study .


Leuprolide acetate depot ( 11.25 or 30 mg ) administered im every 3 months .


Peak-stimulated LH , estradiol , T , growth rate , pubertal progression , and adverse events ( AEs ) .


Twenty-nine of 34 subjects in the 11.25-mg group and 36 of 38 subjects in the 30-mg group had LH values < 4 mIU/mL after day 1 at all time points .


All seven subjects who escaped LH suppression at any time still maintained sex steroid concentrations at prepubertal levels and showed no signs of pubertal progression .


AEs were comparable between groups , with injection site pain being the most common ( 26.4 % overall ) .


No AE led to discontinuation of study drug .


The safety profile over 36 months was comparable to that observed during the 6-month pivotal study .


The two doses of leuprolide acetate 3-month depot were associated with an acceptable safety profile and provided maintenance of LH suppression in the majority of children with CPP during the 36 months of the study or until readiness for puberty .


Patients with renal insufficiency are hyporesponsive to vaccination , including to hepatitis B vaccines .


A manufacturing process modification for a hepatitis B vaccine ( mpHBV ) was studied in renal pre-dialysis and dialysis patients .


This randomized , open-label , multicenter , estimation study enrolled previously unvaccinated , HBV-seronegative adult dialysis and pre-dialysis patients ( N = 276 , median age 72.0 years ) .


At 0 , 1 , 6 , and 8 months , group 1 received a 1 mL intramuscular dose of mpHBV ( containing 40 g HBsAg ) as a single injection , while group 2 received a 1 mL intramuscular dose of a licensed hepatitis B vaccine as two injections ( each containing 20 g HBsAg ; 40 g HBsAg total ) .


Serum antibody to HBsAg ( anti-HBs ) was measured predose 1 , and 1 month postdose 3 and 4 .


Anti-HBs geometric mean concentration ( GMC ) and seroprotection rate ( SPR , % of subjects with anti-HBs titer 10 mIU/mL ) were estimated at months 7 and 9 .


For group 1 , month 7 SPR was 48.5 % ( 49/101 , 95 % CI : 38.4 % , 58.7 % ) ; with an additional dose , month 9 SPR increased to 66.7 % ( 66/99 , 95 % CI : 56.5 % , 75.8 % ) .


For group 2 , month 7 SPR was 57.7 % ( 64/111 , 95 % CI : 47.9 % , 67.0 % ) ; with an additional dose , month 9 SPR increased to 69.2 % ( 72/104 , 95 % CI : 59.4 % , 77.9 % ) .


group 1 GMCs at months 7 and 9 were 27.5 mIU/mL ( 95 % CI : 15.7 , 48.0 ) and 61.7 mIU/mL ( 95 % CI : 34.2 , 111.5 ) , respectively .


group 2 GMCs at months 7 and 9 were 48.7 mIU/mL ( 95 % CI : 28.7 , 82.7 ) and 115.8 mIU/mL ( 95 % CI : 65.2 , 205.5 ) , respectively .


There were 22 serious adverse events ; none were considered related to study vaccine .


Both formulations were immunogenic in this population but required more vaccinations to reach seroprotective levels than comparable regimens in healthy individuals , as expected .


The relatively reduced SPRs seen in this population support the need for routine screening and re-dosing in this population .


Inflammation plays a key role in the development of benign prostatic hyperplasia .


Prostaglandin E2 ( PGE2 ) is an important inflammation factor found in enlarged prostatic tissue that can be the main cause of inflammatory pain .


The aim of this study was to investigate whether epidural anesthesia can block the negative effects of prostaglandin mediators during prostate surgery .


The study included 60 patients who underwent open prostatectomy .


All patients were randomly allocated to one of two study groups .


The first group received general anesthesia and the second group a combination of general and epidural anesthesia .


Main outcome measures were plasma concentration of PGE2 , adrenaline , noradrenaline , and dopamine , before induction of anesthesia and at the time of enucleation .


Preoperative serum concentrations of PGE2 were high in both groups .


During enucleation , serum concentrations of adrenaline , noradrenaline , and dopamine increased , followed by a rise of systolic and diastolic blood pressure in the group of patients that received only general anesthesia .


Serum concentration of PGE2 was at the same level as before induction of anesthesia in both groups .


Epidural anesthesia blocks transmission of painful stimulus through the spinal cord caused by prostaglandin release and prevents the rise of catecholamines and blood pressure .


Open prostatectomy can become a safer procedure performed under a combination of general and epidural anesthesia .


Negative intraoperative effects of inflammatory prostate mediators during other techniques for prostate surgery could also be blocked with epidural anesthesia .


Population pharmacokinetics ( PK ) of azithromycin ( AZ ) and chloroquine ( CQ ) following administration of fixed-dose combination tablet formulations of AZ and CQ ( AZCQ ) was evaluated using data from two studies : 1 ) in children with symptomatic uncomplicated falciparum malaria in sub-Saharan Africa ; and 2 ) in healthy adults in the United States .


Study 1 included paediatric subjects randomized to either AZCQ or artemether-lumefantrine treatment in Cohort 1 ( age 5-12years ) and Cohort 2 ( age 6-59months ) .


Dosing of AZCQ was approximately 30mg/kg AZ and 10mg/kg CQ once daily for 3 days ( for 20kg weight : AZ/CQ 300/100mg per tablet ; 5 to < 20kg weight : AZ/CQ 150/50mg per tablet ) .


Study 2 included adults randomized to receive either two AZCQ tablets ( AZ/CQ 250/155mg per tablet ) or individual commercial tablets of AZ 500mg and CQ 300mg .


Serum AZ and plasma CQ concentrations from both studies were pooled .


Population PK models were constructed using standard approaches to evaluate the concentration-time data for AZ and CQ and to identify any covariates predictive of PK behaviour .


A three-compartment PK model with linear clearance and absorption adequately described AZ data , while a two-compartment model with linear clearance and absorption and an absorption lag adequately described CQ data .


No overall bias or substantial model misspecification was evident using diagnostic plots and visual predictive checks .


Body weight as an allometric function was the only covariate in the final AZ and CQ PK models .


There were significantly lower AZ ( 0.488 vs 0.745 [ mgh/L ] / [ mg/kg ] , p < 0.00001 ) and CQ ( 0.836 vs 1.27 [ mgh/L ] / [ mg/kg ] , p < 0.00001 ) exposures ( AUCinf ) normalized by dose ( mg/kg ) in children compared with the adults .


The PK of AZ and CQ following administration of AZCQ was well described using a three - and two-compartment model , respectively .


AZ and CQ exhibited linear absorption and clearance ; the model for CQ included an absorption lag .


Weight was predictive of exposure for both AZ and CQ .


Assuming equivalent dosing ( mg/kg ) , AZ and CQ exposure in children would be expected to be lower than that in adults , suggesting that children may require a higher dose ( mg/kg ) than adults to achieve the same AZ and CQ exposure .


In the SAVE-trial we evaluated the safety , reliability and improvements of patient management using the BIOTRONIK Home Monitoring-System ( HM ) in pacemaker ( PM ) and implanted cardioverter defibrillator ( ICD ) patients .


115 PM ( Module A ) and 36 ICD-patients ( Module B ) were recruited 3 months after implantation .


65 patients in Module A were randomised to HM-OFF and had one scheduled outpatient clinic follow-up ( FU ) per year , whereas patients randomised to HM-ON were equipped with the mobile transmitter and discharged without any further scheduled in-office FU .


In Module B 18 patients were randomised to HM-OFF and followed by standard outpatient clinic controls every 6 months ; 18 patients were randomised to HM-ON receiving remote monitoring plus one outpatient clinic visit per year ; unscheduled follow-ups were performed when necessary .


The average follow-up period was 17.1 9.2 months in Module A and 26.3 8.6 months in Module B.


In both modules , the number of FUs per year was significantly reduced ( Module A HM-ON 0.29 0.6 FUs/year vs HM-OFF 0.53 0.5 FUs/year ; p b 0.001 ; Module B HM-ON 0.87 0.25 vs HM-OFF 1.73 0.53 FU/year , p b 0.001 ) .


Cost analysis was significantly lower in the HM-ON group compared to the HM-OFF group ( 18.0 41.3 and 22.4 26.9 respectively ; p b 0.003 ) .


93 % of the unscheduled visits in Module B were clinically indicated , whereas 55 % of the routine FUs were classified as clinically unnecessary .


Remote home monitoring of pacemaker and ICD devices was safe , reduced overall hospital visits , and detected events that mandated unscheduled visits .


This study is designed to address the need for evidence-based HIV/STI prevention approaches for drug-involved women under criminal justice community supervision .


We tested the efficacy of a group-based traditional and multimedia HIV/STI prevention intervention ( Project WORTH : Women on the Road to Health ) among drug-involved women under community supervision .


We randomized 306 women recruited from community supervision settings to receive either : ( 1 ) a four-session traditional group-based HIV/STI prevention intervention ( traditional WORTH ) ; ( 2 ) a four-session multimedia group-based HIV/STI prevention intervention that covered the same content as traditional WORTH but was delivered in a computerized format ; or ( 3 ) a four-session group-based Wellness Promotion intervention that served as an attention control condition .


The study examined whether the traditional or multimedia WORTH intervention was more efficacious in reducing risks when compared to Wellness Promotion ; and whether multimedia WORTH was more efficacious in reducing risks when compared to traditional WORTH .


Primary outcomes were assessed over the 12-month post-intervention period and included the number of unprotected sex acts , the proportion of protected sex acts , and consistent condom use .


At baseline , 77 % of participants reported unprotected vaginal or anal sex ( n = 237 ) and 63 % ( n = 194 ) had multiple sex partners .


Women assigned to traditional or multimedia WORTH were significantly more likely than women assigned to the control condition to report an increase in the proportion of protected sex acts ( = 0.10 ; 95 % CI = 0.02-0 .18 ) and a decrease in the number of unprotected sex acts ( IRR = 0.72 ; 95 % CI = 0.57-0 .90 ) .


The promising effects of traditional and multimedia WORTH on increasing condom use and high participation rates suggest that WORTH may be scaled up to redress the concentrated epidemics of HIV/STIs among drug-involved women in the criminal justice system .


ClinicalTrials.gov NCT01784809 .


Ligand-mediated activation of the androgen receptor ( AR ) is critical for prostate cancer ( PCa ) survival and proliferation .


The failure to completely ablate tissue androgens may limit suppression of PCa growth .


We evaluated combinations of CYP17A and 5 -- reductase inhibitors for reducing prostate androgen levels , AR signaling , and PCa volumes .


Thirty-five men with intermediate/high-risk clinically localized PCa were randomly assigned to goserelin combined with dutasteride ( ZD ) , bicalutamide and dutasteride ( ZBD ) , or bicalutamide , dutasteride , and ketoconazole ( ZBDK ) for 3 months before prostatectomy .


Controls included patients receiving combined androgen blockade with luteinizing hormone-releasing hormone agonist and bicalutamide .


The primary outcome measure was tissue dihydrotestosterone ( DHT ) concentration .


Prostate DHT levels were substantially lower in all experimental arms ( 0.02 to 0.04 ng/g v 0.92 ng/g in controls ; P < .001 ) .


The ZBDK group demonstrated the greatest percentage decline in serum testosterone , androsterone , and dehydroepiandrosterone sulfate ( P < .05 for all ) .


Staining for AR and the androgen-regulated genes prostate-specific antigen and TMPRSS2 was strongly suppressed in benign glands and moderately in malignant glands ( P < .05 for all ) .


Two patients had pathologic complete response , and nine had 0.2 cm ( 3 ) of residual tumor ( defined as a near-complete response ) , with the largest numbers of complete and near-complete responses in the ZBDK group .


Addition of androgen synthesis inhibitors lowers prostate androgens below that achieved with standard therapy , but significant AR signaling remains .


Tissue-based analysis of steroids and AR signaling is critical to informing the search for optimal local and systemic control of high-risk prostate cancer .


This prospective registry assessed the safety and efficacy of paclitaxel coated balloon ( PCB ) angioplasty for small vessel coronary artery disease in Europe and Asia with the intention to treat lesions without additional stenting .


The use of PCBs in small vessels seems to be associated with favourable outcomes ; however , prospective data for the use of PCBs without stenting are limited .


The SeQuent Please Small Vessel ` PCB only ' Registry was an international , prospective , multicentre registry enrolling patients with de novo lesions of small reference diameters ( 2.0 mm , 2.75 mm ) .


The primary end point was clinically driven target lesion revascularisation ( TLR ) at 9 months .


Secondary end points were acute technical success , in-hospital outcomes , 9-month major adverse cardiac events ( MACE ) ( death , myocardial infarction , or TLR ) , and the occurrence of definite lesion and vessel thrombosis .


A total of 479 patients ( 66.1 10.9 years , 36.7 % diabetics ) were enrolled , 105 ( 23.5 % ) with an acute coronary syndrome , 41 ( 9.2 % ) with ST elevation myocardial infarction ( STEMI ) , and 60 ( 14.8 % ) with non-STEMI .


The initial procedural success rate was 99.0 % ; 27 patients ( 6 % ) needed additional bare metal stent implantation .


TLR at 9.41.7 months occurred in 14 patients ( 3.6 % ) , while three patients ( 0.6 % ) had vessel thrombosis in non-target lesions .


There was no cardiac death or coronary artery bypass graft surgery .


To date , this is the largest prospective study with PCBs in small vessel de novo lesions in unselected patients .


Rates of TLR and MACE were low , suggesting the use of PCBs may be an attractive alternative treatment option to drug eluting stents in small vessels .


This study aimed to determine the safety and efficacy of intraoperative intensive glycaemic treatment with modified glucose-insulin-potassium solution by hyperinsulinemic normoglycaemic clamp in cardiopulmonary bypass surgery patients .


We hypothesised that the treatment would reduce infection rates in this group of patients .


A prospective , randomised , double-blind trial was conducted in cardiopulmonary bypass surgery patients .


A total of 199 adult patients ( out of a planned 400 ) were randomly allocated to intensive or conventional treatment with target glucose levels of 4.4-8 .3 mmol/l and < 13.8 mmol/l , respectively .


The primary outcomes were clinical infection and cytokine levels , including interleukin ( IL ) -6 and IL-10 .


The secondary outcomes were morbidity and mortality .


The study was terminated early because of safety concerns ( hypoglycaemia ) .


The clinical post-operative infection rate was 17 % in the intensive group and 13 % in the conventional group ( P = 0.53 ) .


The proportion of patients with hypoglycaemia was significantly higher in the intensive group ( 23 % ) compared with the conventional group ( 3 % ) ( P < 0.001 ) .


Morbidity and mortality rates were similar for both groups .


Anaesthetic duration > 2 h ( vs. 2 h ) , pre-operative IL-6 level > 15 pg/ml ( vs. 15 pg/ml ) and post-operative IL-6 level 56-110 pg/ml ( vs. 55 pg/ml ) were independent predictors for post-operative infection .


Intraoperative intensive glycaemic treatment significantly increased the risk of hypoglycaemia , but its effect on post-operative infection by clinical assessment could not be determined .


Anaesthetic duration , pre-operative and post-operative IL-6 levels can independently predict post-operative infection .


Preclinical and clinical trials suggest that yohimbine may augment extinction learning without significant side effects .


However , previous clinical trials have only examined adults with specific phobias .


Yohimbine has not yet been investigated in the augmentation of exposure therapy for other anxiety disorders .


Adults ( n = 40 ) with a DSM-IV diagnosis of social anxiety disorder were randomized to placebo or yohimbine HCl ( 10.8 mg ) 1 hour before each of four exposure sessions .


Outcome measures were collected at baseline , each treatment session , posttreatment , and 1-month follow-up .


Yohimbine was well tolerated .


Yohimbine augmentation , relative to placebo augmentation , resulted in faster improvement and better outcomes on self-report measures of social anxiety disorder severity ( Liebowitz Social Anxiety Scale , d = .53 ) and depressed mood severity ( Beck Depression Inventory , d = .37 ) but not on the clinician-rated measures ( Clinical Global Impressions-Severity Scale , d = .09 ; Clinical Global Impressions-Improvement Scale , d = .25 ) .


Between-group differences on the Liebowitz Social Anxiety Scale were moderated by the level of fear reported at the end of an exposure exercise ( end fear ) , such that the advantage of yohimbine over placebo was only evident among patients who reported low end fear .


The results provide moderate support for yohimbine as a therapeutic augmentation strategy for exposure therapy in social anxiety disorder , one that may be especially effective when coupled with successful exposure experiences .


Beneficial effects for yohimbine were readily evident for self-report measures but not for clinician-rated outcomes of social anxiety severity and improvement .


The aim of this study was to evaluate the effect of long-term administration of liquid nutritional supplement with increased amounts of whey protein and reduced amounts of lactose , produced in accordance with a new recipe `` Nutrisen '' on the elderly living in institutionalized care .


The study was carried out from May to July , 2013 , on 47 retirement home residents , living in Prague , all of which were 65 years or older .


Supplemented group ( n = 23 ) consumed ( 200 ml ) milk drinks with three different flavours on a daily basis for eight weeks .


The reference group was on a normal diet .


There was no significant difference in baseline characteristics between participants in both groups .


Anthropometric and biochemical indicators of nutritional status and tolerance of the nutritional supplement during long-term use were evaluated .


Both compliance ( daily intake program ) and tolerance of the nutritionally defined supplement were very good .


For the supplemented group , there was an average weight increased of 700 grams after the 8 week nutritional supplement test period .


Average levels of albumin and prealbumin increased significantly ( from the beginning to the end of the program ) , 35.5 4.52 g/l vs 36.19 4.1 g/l and 0.160 0.05 vs 0.174 0.04 g/l ( p < 0.05 ) , vitamin D levels increased from 31.2 16.4 nmol/l to 36.8 17.7 nmol/l ( p < 0.001 ) and HDL-cholesterol levels increased from 1.29 0.33 mmol/l to 1.35 0.35 mmol/l ( p < 0.001 ) .


The specific nutritionally defined milk drink ( Nutrisen ) , used in this study , was well tolerated by the elderly study participants , over the eight-week clinical study .


We observed a positive effect on the participants weight , serum albumin , prealbumin , vitamin D and HDL-cholesterol .


Insight into delusional beliefs varies in patients with major depressive disorder ( MDD ) with psychotic features ( `` psychotic depression '' ) .


The relationship between impaired insight and illness severity and its impact on treatment outcomes has not been studied in psychotic depression .


As such , the aim of this analysis was to explore the relationship among impaired insight , patient characteristics ( ie , illness severity , cognition , suicidality , and social functioning ) , and treatment outcome ( ie , remission ) during acute treatment of psychotic depression .


This secondary analysis is based on the data from the Study of Pharmacotherapy for Psychotic Depression ( STOP-PD ) in which 259 participants meeting DSM-IV criteria for MDD with psychotic features enrolled between December 2002 and June 2007 ( including 142 aged 60 years ) in a 4-center , 12 - week , double-blind , randomized controlled trial funded by the US National Institutes of Health .


Insight into delusions was assessed using the Delusion Assessment Scale ( DAS ) .


The primary outcomes were the predictive utility of insight into illness ( ie , Hamilton Depression Rating Scale [ HDRS ] insight item ) and insight into delusions ( conviction factor derived from the DAS ) on final treatment outcome at 12 weeks of treatment ( ie , full remission , partial remission , and nonremission ) .


At baseline , impaired insight into delusions was positively associated with illness severity ( HDRS-16 which excluded the insight item , r = 0.15 , P = .016 ) and negatively correlated with measures of cognition ( P < .05 ) .


Improvement in insight was not associated with changes in cognition , suicidality , or social functioning after adjusting for covariates .


Independent of the severity of depression or psychosis , impaired insight into delusions at baseline ( = 11.65 , P = .020 ) and after 3 ( = 9.62 , P = .047 ) , 6 ( = 6.97 , P = .031 ) , and 8 ( = 9.08 , P = .011 ) weeks of treatment predicted remission at the end of the trial .


Impaired insight into delusions appears to be an independent predictor of remission in MDD with psychotic features during acute treatment , suggesting that more attention should be paid to this symptom .


Longitudinal studies are required to determine the impact of impaired insight into delusions on long-term outcomes , including relapse .


ClinicalTrials.gov identifier : NCT00056472 .


Therapy-induced mucositis and dysphagia puts head and neck ( H&N ) cancer patients at increased risk for developing cachexia .


Omega-3 fatty acids ( n-3 FA ) have been suggested to protect against cachexia .


We aimed to examine if echium oil , a plant source of n-3 FA , could reduce weight loss in H&N cancer patients undergoing radio ( chemo ) therapy with curative intent .


In a double-blind trial , patients were randomly assigned to echium oil ( intervention ( I ) group ; 7.5 ml bis in die ( b.i.d. ) , 235 mg/ml - linolenic acid ( ALA ) + 95 mg/ml stearidonic acid ( SDA ) + 79 mg/ml - linolenic acid ( GLA ) ) or n-3 FA deficient sunflower oil high oleic ( control ( C ) group ; 7.5 ml b.i.d. ) additional to standard nutritional support during treatment .


Differences in percentage weight loss between both groups were analysed according to the intention-to-treat principle .


Erythrocyte FA profile , body composition , nutritional status and quality of life were collected .


Ninety-one eligible patients were randomised , of whom 83 were evaluable .


Dietary supplement adherence was comparable in both groups ( median , I : 87 % , C : 81 % ) .


At week 4 , the I group showed significantly increased values of erythrocyte n-3 eicosapentanoic acid ( EPA , 14 % vs -5 % ) and n-6 GLA ( 42 % vs -20 % ) compared to the C group , without a significant change in n-6 arachidonic acid ( AA , 2 % vs -1 % ) .


Intention-to-treat analysis could not reveal a significant reduction in weight loss related to echium oil consumption ( median weight loss , I : 8.9 % , C : 7.6 % ) .


Also , no significant improvement was observed in the other evaluated anthropometric parameters .


Echium oil effectively increased erythrocyte EPA and GLA FAs in H&N cancer patients .


It failed however to protect against weight loss , or improve nutritional parameters .


ClinicalTrials.gov Identifier NCT01596933 .


To evaluate the expression of matrix metalloproteinase 9 ( MMP9 ) and transglutaminase 2 ( TG2 ) in different forms of dry eye .


Case control study .


Seventy-five female subjects divided into 3 groups : group 1 , 15 healthy controls ; group 2 , 30 subjects with Sjgren syndrome ( SS ) ; and group 3 , 30 subjects with Meibomian gland dysfunction ( MGD ) .


A clinical assessment was carried out and impression cytologic specimens were processed for immunoperoxidase staining for MMP9 and TG2 and real-time polymerase chain reaction analyses were carried out for MMP9 , TG2 , interleukin-6 , interferon - , B-cell lymphoma 2 , and caspase 3 .


To study MMP9 and TG2 expression after anti-inflammatory treatment , patients were divided into 2 subgroups , one treated with saline and the other treated with saline plus topical corticosteroid eye drops ( 0.5 % loteprednol etabonate ) 4 times daily for 15 days .


For statistical analysis , Student t test , Mann-Whitney U test , and Spearman 's correlation coefficient were used as appropriate .


Conjunctival expression of MMP9 and TG2 .


MMP9 and TG2 expression were higher in both patient groups than in controls ( P < 0.0001 ) .


Group 2 patients showed higher expression than group 3 ( P < 0.0001 ) .


The Spearman 's correlation coefficient showed in group 2 a positive correlation between MMP9 and TG2 expression ( = 0.437 ; P = 0.01 ) , but no correlation in group 3 ( = 0.143 ; P = 0.45 ) .


Corticosteroid treatment significantly reduced MMP9 and TG2 expression in both groups , ameliorating symptoms and signs .


A much higher percentage reduction was observed in SS .


The pathogenic mechanisms of the 2 forms of dry eye give an account for the different MMP9 and TG2 expressions in the 2 groups of patients .


The higher expression in SS is determined by the direct autoimmune insult to the ocular surface epithelia , whereas in MGD patients , with an epithelial damage due to an unbalanced tear secretion , the molecules expression is significantly lower , although higher than in controls .


The corticosteroid treatment induced a reduction of both molecules , although higher in SS than in MGD , because of its direct inhibitory effect on inflammation .


Few studies have examined the differential effects of weight management by exercise mode on subclinical atherosclerosis .


We hypothesized that 3 modes of aerobic , resistance , and combination exercises have differential effects on the flow-mediated dilation ( FMD ) , carotid-femoral pulse wave velocity ( PWV ) , and carotid intima-media thickness ( IMT ) as well as cardiometabolic profile in weight management .


A randomized , single-blind trial ( ISRCTN46069848 ) was conducted in Seoul , South Korea between November 2011 and December 2012 .


Randomized participants were 110 women with abdominal obesity ( aerobic group n = 50 ; resistance group n = 30 ; combination exercise group n = 30 ) .


The treatment period was 12 months with 3-month follow up : A diet-alone intervention for the first 3 months and a diet-plus-exercise intervention for the next 9 months according to exercise modes .


The exercise training was designed with an intensity of 50-70 % heart rate reserve for 3 days a week in 60-minute-long sessions for 9 months , consisting of 30-minute treadmill and 30-minute bike exercises for aerobic group ; upper and lower body exercises with an intensity target of 2 sets and 8-12 repetitions for resistance group ; 30-minute resistance and consecutive 30-minute aerobic exercises for combination group .


Ninety-two and 49 participants were analyzed for modified intention-to-treat analysis and per-protocol ( PP ) analysis , respectively .


The 3 exercise modes had no significant differential effects on FMD , PWV , and IMT over time ; however , the combination group was found to have significantly lower levels of fasting glucose than the aerobic group ( p = .034 ) in the PP analysis .


Nevertheless , we observed significant time effects such as reductions in PWV ( p = .048 ) and IMT ( p = .018 ) in cubic and quadratic trends , respectively , and improvements in body weight , waist circumference , low-density and high-density lipoprotein cholesterol levels , fasting glucose levels , and cardiorespiratory fitness in linear , quadratic , or cubic trends .


For women with abdominal obesity , a combination of aerobic and resistance exercises may be preferable to a single exercise mode for effective glucose control .


Regardless of exercise mode , exercise interventions combined with dietary interventions in weight management may be beneficial in reducing the risk of subclinical atherosclerosis and cardiometabolic risk .


We recently completed a randomized controlled trial of an endoscopic quality improvement program ( EQUIP ) that demonstrated an improved adenoma detection rate ( ADR ) through simple educational interventions .


The aim of this study ( phase III ) is to examine whether the improvement in ADR in the trained endoscopists remained stable with further follow-up .


We prospectively followed up 15 staff endoscopists who had previously been randomized to a quality improvement intervention .


In the current study , we examined an additional 1,200 colonoscopy procedures conducted over a 5-month time period following the original study , referred to as phase III .


During this time , all physicians received quarterly ADR and other quality metric feedback , and the previous control group was offered the educational intervention voluntarily .


ADRs and adenoma per patient ( APP ) rates were estimated in the endoscopists who were and were not randomized to EQUIP training and compared with those obtained in phases I and II of the original study .


The study was conducted in a tertiary care Academic Medical Center .


The study sample comprised 1200 patients undergoing routine colonoscopy .


The main outcome measurement was adenoma detection rate .


The previously observed increase in ADR in the trained group from 36 % in phase I to 47 % in phase II was maintained into phase III ( 46 % ) .


The ADR of the untrained group remained unchanged from phase I ( 36 % ) to phase II ( 35 % ) ; it was increased only marginally in phase III to 39 % , which was still lower than the 46 % ADR in the trained group .


The trained group had an increase in APP , from 0.72 in Phase I to 0.87 in Phase II and 0.98 in Phase III .


For the previously untrained group , there was no change in APP from phase I ( 0.68 ) to phase II ( 0.68 ) , but there was possibly a small increase ( to 0.74 ) in Phase III .


This study provides evidence that improvements in ADR obtained through the endoscopic quality-training program can persist for at least 5 months after completion of the program .


It further suggests that a focus on ADR does not lead to a `` one and done '' phenomenon .


The limitations of this study were as follows : single-center setting , and lack of sessile polyp information/standardization .


To evaluate the condition of cancer-related fatigue ( CRF ) in breast cancer patients with chemotherapy and to explore the effect of Yoga on it .


After the completion of Yoga , 100 breast cancer patients with CRF ( CFS > 0 ) were selected and were randomly divided into the Yoga group and the control group ( n = 50 ) .


Patients in the control group only received routine cure and care while patients in the Yoga group received extra Yoga exercise , lasting for 4 months .


Cancer fatigue scale ( CFS ) was evaluated in the 2nd , 4th and 6th round of chemotherapy .


At the end , 82 cases qualified for the study , 42 cases for the control group and 40 for the Yoga group .


The mean score of body fatigue was 12.673.46 .


There was no significant difference in CRF between the Yago group and the control group before the Yoga intervention ( P > 0.05 ) .


After the 4th round of chemotherapy , the mean scores of CFS and body fatigue in the Yoga group were significantly lower than that in the control group ( P < 0.05 ) .


After the 6th round of chemotherapy , the mean scores of CFS , body fatigue and cognitive fatigue in the Yoga group were lower than that in the control group ( P < 0.05 ) .


Repeated analysis of variance showed that the difference in the overall fatigue , body fatigue and cognitive fatigue between the Yoga group and the control group was significant ( P < 0.05 ) ; the time influence on the overall fatigue , body fatigue and emotional fatigue was significant difference between the 2 groups ( P < 0.05 ) ; there were interactions between the effect of Yago and time on the overall fatigue , body fatigue and cognitive fatigue ( P < 0.05 ) .


The body fatigue was more serious in breast cancer patients with chemotherapy .


Yoga intervention could significantly reduce body fatigue , cognitive fatigue , thus reduce the overall fatigue in breast cancer patients with chemotherapy .


To assess the efficacy and safety of LY500307 , a selective estrogen receptor beta agonist , on lower urinary tract symptoms ( LUTS ) in patients with enlarged prostate secondary to BPH .


In a randomized , double-blind , placebo-controlled , parallel phase 2 , efficacy and safety study , eligible patients with moderate to severe LUTS and prostatic enlargement ( 30ml ) were randomized to placebo or LY500307 at 1 , 3 , 10 and 25mg once daily for 24 weeks .


Primary efficacy end point was change in total International Prostate Symptoms Score ( IPSS ) after 24 weeks .


Secondary end points included changes in total prostate volume ( TPV ) that served as a proof of concept end point , as well as IPSS quality of life , maximum peak urine flow rate ( Qmax ) and PSA and safety ( adverse events , laboratory test ) .


A total of 414 patients were randomized when the study was terminated because of insufficient TPV reduction , based on a priori defined interim analysis .


The IPSS mean change from baseline to end point was -3.46.8 in the placebo group and -1.36.6 , -2.67.0 , -3.76.7 and -4.45.7 in the 1 , 3 , 10 and 25mg LY500307-treated groups , respectively ( P > 0.05 ) .


Similarly , no treatment effect was observed for any of the secondary efficacy measures .


Incidence of adverse events was comparable between treatment groups , and no clinically meaningful changes in laboratory tests were observed .


LY500307 was well tolerated in BPH patients with LUTS at doses up to 25mg once daily for 24 weeks .


The study was terminated early because of inadequate efficacy .


Phosphodiesterase-5 ( PDE5 ) inhibitors improve exercise capacity and quality of life in patients with idiopathic pulmonary arterial hypertension .


However , whether such beneficial effects take place in selected populations with chronic obstructive pulmonary disease ( COPD ) remains uncertain .


We aimed to assess the effects of tadalafil -- a PDE5 inhibitor -- on exercise capacity and quality of life in patients with COPD and mild pulmonary hypertension .


We did a randomised , double-blind , parallel-group , placebo-controlled trial at three centres in Scotland , UK , between Sept 1 , 2010 , and Sept 1 , 2012 .


Patients with moderate to severe COPD were randomly assigned ( 1:1 ) , via centralised randomisation with a computer-generated sequence and block sizes of four , to receive daily tadalafil 10 mg or placebo for 12 weeks .


Patients , study investigators , outcome assessors , and those administering drugs were masked to group allocation .


The primary endpoint was the mean placebo-corrected difference between the baseline and final 6 min walk distance after 12 weeks .


We measured change in quality of life at baseline , 8 weeks , and 12 weeks , with standardised questionnaires .


Analysis was per protocol and by intention to treat .


This trial is registered with ClinicalTrials.gov , number NCT01197469 .


120 patients were randomly assigned to receive tadalafil ( n = 60 ) or placebo ( n = 60 ) , of whom 56 ( 93 % ) versus 57 ( 95 % ) completed the study .


At 12 weeks the difference in 6 min walking distance between the tadalafil and placebo groups was 05 m ( 95 % CI -116 to 125 ; p = 0937 ) .


We recorded no statistically significant changes in quality of life ( between-group difference on the St George 's Respiratory Questionnaire -264 [ 95 % CI -643 to 115 ] ; Research and Development version 1 short-form-36 408 [ -135 to 952 ] ; Minnesota Living with Heart Failure questionnaire -231 [ -706 to 245 ] ) .


19 ( 32 % ) of 60 patients in the treatment group had dyspepsia ; the severity of dyspepsia ranged from mild to severe , with four ( 21 % ) of 19 patients needing a proton-pump inhibitor .


Five ( 8 % ) of 60 participants had dyspepsia in the placebo group .


Headache was noted in 17 ( 28 % ) patients in the treatment group versus 5 ( 8 % ) in the placebo group , but was mild in all patients .


Two ( 3 % ) patients in the treatment group had facial flushing , which resulted in one withdrawal .


Other withdrawals within the tadalafil group happened after a transient ischaemic attack and two deaths ( ruptured abdominal aortic aneurysm and pneumonia ) .


Tadalafil does not improve exercise capacity or quality of life despite exerting pulmonary vasodilation .


Chief Scientist Office for Scotland .


Dysregulated immune responses may contribute to the clinical complications that occur in some patients with dengue .


In Vietnamese pediatric dengue cases randomized to early prednisolone therapy , 81 gene-transcripts ( 0.2 % of the 47,231 evaluated ) were differentially abundant in whole-blood between high-dose ( 2 mg/kg ) prednisolone and placebo-treated patients two days after commencing therapy .


Prominent among the 81 transcripts were those associated with T and NK cell cytolytic functions .


Additionally , prednisolone therapy was not associated with changes in plasma cytokine levels .


The inability of prednisolone treatment to markedly attenuate the host immune response is instructive for planning future therapeutic strategies for dengue .


Recent clinical trials suggested that abdominal drainage is not needed in all cases and should be restricted in patients with chronic liver disease or patients who underwent minor liver resection .


In this study we conducted a randomized study to determine whether abdominal drainage is beneficial or rather hazardous after hepatic resection .


Two hundred consecutive patients undergoing elective hepatectomy were entered for this prospective , randomized , case-controlled study .


Liver resection was performed under intermittent Pringle maneuver .


Clinical data such as postoperative complications and mortality rates were evaluated as well as intraoperative parameters .


There were no significant differences in postoperative morbidity between with and without abdominal drainage groups 16 vs. 12 % ) .


However , complications directly related no drainage such as drain site bleeding and infection , abdominal abscess , bile fistula , and ascites ( CDRD ) tended to be higher in the drainage group than the no-drainage group ( 9 vs. 3 % , p = 0.067 ) .


Particularly , there was high incidence of CDRD in the drainage group compared with the no drainage group in patients with chronic liver diseases ( 13.2 vs. 1.8 % , p = 0.027 ) .


We do not recommend systematic drainage after elective hepatectomy , irrespective of the extent of resection and of the underlying liver diseases when the surgical procedure has been satisfactory .


Adding nitroglycerin to the combination of vinorelbine plus cisplatin has been reported to improve the overall survival ( OS ) of Asian patients with stage IIIB/IV non-small cell lung cancer ( NSCLC ) probably due to better drug delivery based on changed vascular tonus .


The main objective of our study was to evaluate the effect of adding nitroglycerin to vinorelbine and cisplatin in a Caucasian population .


66 chemonave patients with stage IIIB/IV NSCLC received oral vinorelbine ( first cycle 60 mg/m ( 2 ) , subsequent cycles : 80 mg/m ( 2 ) in the absence of any hematological toxicity grade 3 in cycle 1 ) once daily on days 1 and 8 of each cycle and cisplatin ( 80 mg/m ( 2 ) i.v. ) on day 1 of each cycle ( q3w ) .


Nitroglycerin ( arm A , n = 34 ) or placebo patches ( arm B , n = 32 ) were administered once daily from day -3 to day 2 of each cycle and were removed about 12h after administration .


One nitroglycerin patch contained 25mg nitroglycerin .


Median age was 62.5 ( 33-82 ) years .


In the overall population ( n = 66 ) , the objective response rate ( ORR ) was 27.3 % ( all PR ; 95 % CI : 17.0-39 .6 ) , with a disease control rate ( DCR ) of 57.6 % ( 95 % CI : 44.8-69 .7 ) , a median time to progression ( TTP ) of 4.8 months ( n = 58 ; 95 % CI : 3.4-5 .9 ) and a median overall survival ( OS ) of 11.5 months ( 95 % CI : 7.9-13 .6 ) .


ORR and DCR were numerically higher in arm A than in arm B ( 35.3 % vs. 18.8 % and 61.8 % vs. 53.1 % , respectively ) , whereas TTP and OS were comparable .


The main hematological and non-hematological toxicities grade 3 were moderate with no significant differences between the two treatment arms .


Overall , oral vinorelbine plus cisplatin showed a high level of efficacy and adequate tolerability in first line treatment of NSCLC .


Despite the low sample size per group the results seem to confirm the previous results reported in Asian patients .


An inability to show consistent relationships between gene variants and blood pressure ( BP ) may be confounded by the use of office BP measurement .


Whether the difference between office BP and day BP ( office-day ) is genetically predetermined is unknown .


We therefore aimed to determine the intrafamilial aggregation and heritability of office-day BP .


Nurse-derived office BP ( mean of 5 measurements according to guidelines ) and 24-h ambulatory BP were determined for 592 participants from 198 families ( 67 spouse pairs , 361 parent-child pairs , and 169 sibling-sibling pairs ) , with 12 families having three generations , from an urban developing community of black Africans .


Heritability estimates were determined using SAGE software .


With adjustments for confounders , office systolic BP ( SBP ) ( h = 0.350.09 , P < 0.0001 ) showed comparable heritability estimates to 24-h SBP ( h = 0.330.09 , P < 0.0001 ) .


Similarly , with adjustments for confounders , office diastolic BP ( DBP ) ( h = 0.370.09 , P < 0.0001 ) showed comparable heritability estimates as 24-h DBP ( h = 0.350.09 , P < 0.0001 ) .


However , multivariate adjusted heritability estimates of day SBP ( h = 0.290.09 , P < 0.0001 ) and DBP ( h = 0.330.09 , P < 0.0001 ) were not diminished by further adjustments for office SBP ( h = 0.420.09 , P < 0.0001 ) or DBP ( h = 0.340.09 , P < 0.0001 ) .


Further , independent of confounders , office-day BP showed significant intrafamilial aggregation and heritability ( SBP : h = 0.510.10 , P < 0.0001 ; DBP : h = 0.370.09 , P < 0.0001 ) , effects that persisted with further adjustments for office , day , or day-night BP ( P < 0.0005 for SBP and DBP ) .


Although office and ambulatory BP may show similar heritability estimates , genetic associations with carefully determined office BP measurements may be confounded by the heritability of office-day BP differences .


To establish if women obtain any measurable short term psychological benefit or perceived benefit from having a test to determine the probability of their pregnancy being on-going when this is uncertain on ultrasound examination .


This was a prospective randomised controlled study conducted January 2012-June 2012 at the EPU of King 's College Hospital .


The study population was women who conceived spontaneously and had a single intrauterine gestational sac of < 20mm mean diameter , with no visible embryo on their first ultrasound scan .


Eligible women were randomised to have a test to calculate the probability of viability ( cases ) or not ( controls ) .


Depression and anxiety levels were calculated using the Hospital Anxiety and Depression Score ( HADS ) and were performed prior to randomisation and seven days later .


A repeat scan for pregnancy outcome was performed after one to two weeks as clinically indicated .


A sample size of 69 in each group was calculated to have 80 % power to detect a probability of 0.362 that an observation in the cases was less than an observation in controls using a Wilcoxon Mann-Whitney rank-sum test with a 0.05 two-sided significance .


At recruitment there was no significant difference in anxiety levels between cases and controls .


After seven days anxiety levels were significantly lower in cases than controls ( p = 0.04 ) .


Of those who received the probability score , 55/70 ( 78.6 % 95 % CI 67.5-86 .7 % ) found it useful and 58/70 ( 82.9 % 95 % CI 72.2-90 .1 ) would choose to have the test in a future pregnancy if indicated .


This study has demonstrated that there is evidence of psychological benefit from a simple blood test that gives women the likelihood that their pregnancy will be on-going at the next scan .


The addition of a DDP4-inhibitor to existing insulin therapy reduces HbA1c .


However , no data exist about the addition of these agents at the beginning of insulin treatment in type 2 diabetes while this could especially be interesting because it is during this period that considerable residual beta cell function is still present .


The benefit of such a strategy could be a lower insulin dose required for glycemic control .


The hypothesis of our study was that adding a DPP4-inhibitor at the beginning of insulin treatment could lead to less exogenous insulin requirement , a reduction of hyperinsulinemia and side effects ( hypoglycemia and weight gain ) , less glucose variability and improvement of insulin and glucagon dynamics during a mixed meal test .


In this small clinical trial ( trial registration NTR2022 ) 9 patients were randomized to receive vildagliptin and 6 to receive placebo in addition to start of once daily insulin treatment .


Unfortunately , due to a difficult inclusion , the preset sample size of 40 patients could not be met .


Median units of insulin at the end of the study was 47 U in the placebo group and 34 U in the vildagliptin group .


Median glycemic variability ( SD ) at the end of study was 2.1 in the placebo group and 1.5 in the vildagliptin group .


Median weight gain at the end of study was 3 kg in the placebo and 0.5 kg in the vildagliptin group .


Occurrence of hypoglycemia was low in both groups .


Insulin , C-peptide , glucose and glucagon levels were comparable during mixed meal tests .


This small randomized study did not have sufficient power to detect effects of the addition of vildagliptin to the start of once daily long-acting insulin .


However in our opinion adding a DPP4-inhibitor , especially in this group remains a very interesting approach .


This study could be used as a guidance for larger studies that are required to investigate the effects of this intervention on insulin requirements , glycemic variability , hypoglycemia and weight gain .


It has been reported that adequate calcium intake decreases body fat and appropriate intakes of magnesium suppress the development of the metabolic syndrome .


Furthermore , lactulose increases the absorption of calcium and magnesium .


An optimal combination of calcium , magnesium and lactulose may therefore reduce body fat mass .


An open-label randomized controlled trial was conducted to investigate the body fat-reducing effects of a test food containing 300 mg calcium , 150 mg magnesium , and 4.0 g lactulose .


Body composition parameters and blood hormone and urine mineral concentrations were measured at baseline and at 6 and 12 months thereafter .


Whole-body fat mass was measured with dual-energy x-ray absorptiometry .


Seventy-six middle-aged Japanese women ( 47.54.7 years ) were randomized to the intake group ( n = 48 ) or the non-intake control group ( n = 28 ) .


At 12 months the difference in body fat mass change between the two groups ( intake group - control group ) was -0.8 kg ( 95 % CI : -1.5 - 0.0 kg , p = 0.046 ) , although there were no differences in anthropometric data between the two groups .


Body fat percentage at 12 months tended to be lower in the intake group , but the difference was not significant ( p = 0.09 ) .


These findings may suggest that calcium in combination with magnesium and lactulose can reduce body fat mass in middle-aged Japanese women .


However , the contribution of magnesium and lactulose are unclear in this study .


Further studies are needed to clarify these contributions .


The present study investigated the effects of severe-intensity interval training at a frequency of once a week on cardiorespiratory function at rest and during exercise .


Fourteen young healthy males were randomly assigned to either an interval training group or control group .


Cardiorespiratory function was investigated by incremental maximal exercise test and constant work rate submaximal exercise test before and after the intervention period in all subjects .


Submaximal exercise test was conducted at two work rates ( 80 % ventilatory threshold ( VT ) level and 100 % VT level plus 50 % of the difference between VT and peak oxygen consumption ( VO2 ) ) for 8 min ; the same work rates and duration were used before and after training .


Left ventricular adaptations were assessed by echocardiography under supine resting conditions before and after training .


In the interval training group , seven subjects performed cycle ergometer training once per week for 3 months .


The training consisted of three bouts of exercises to volitional fatigue at 80 % maximum work rate .


Increased VO2max ( +13 % , P = 0.015 ) , VT ( +21 % , P = 0.001 ) , and left ventricular posterior wall thickness ( +18 % , P = 0.002 ) and reduced minute ventilation ( -12 % , P = 0.032 ) and blood lactate concentration ( -16 % , P = 0.025 ) during high-intensity exercise were observed after the training program compared with baseline .


Although not significant , VO2 and cycling economy ( VO2 per work rate ) during high-intensity exercise decreased slightly after training .


The present results indicate that severe-intensity interval training , even when performed at a low frequency , markedly improves cardiorespiratory function as well as induces cardiac morphological adaptations involving left ventricular hypertrophy and cardiorespiratory metabolic response during submaximal exercise .


The present findings may provide new insights for low-frequency , severe-intensity interval training in the field of sports science .


Communication , impulse control and motivation can all be affected by Bipolar Disorder ( BD ) making consistent parenting more difficult than for parents without mental health problems .


Children of parents with BD ( CPB ) are at significantly increased risk of a range of mental health issues including Attention Deficit Hyperactivity Disorder ( ADHD ) , anxiety , depression , substance use , and sleep disorders .


Furthermore , CPB are also at elevated risk for BD compared to the general population .


This paper describes the rationale and protocol for a pilot randomised controlled trial ( RCT ) designed to assess the feasibility and acceptability of a new online intervention providing interactive psychoeducational information and parenting support for parents with BD .


This article describes a single-blind randomised controlled trial comparing an Integrated Bipolar Parenting Intervention ( IBPI ) in addition to treatment as usual ( TAU ) with TAU alone .


Participants will be recruited from across the UK from mental health services and through self-referral .


The primary outcome of the study is the feasibility and acceptability of IBPI as indicated by recruitment to target , use of the intervention site , and retention to follow-up .


Parents with BD allocated to the IBPI condition will have access to the intervention for 16 weeks .


Effect size estimates will be obtained with respect to child behaviour , parenting skills and measures of parental mental health using measures taken at baseline ( 0 ) , and at 16 , 24 , 36 , and 48 weeks post randomization .


This is the first randomised controlled trial of an integrated bipolar disorder parenting intervention .


The benefits and challenges of delivering this online intervention , and evaluation using online RCT methodology are discussed .


Current Controlled Trials ISRCTN75279027 Registered 12 August 2013 .


To ( 1 ) investigate effects of aerobic walking on motor function , cognition , and quality of life in Parkinson disease ( PD ) , and ( 2 ) compare safety , tolerability , and fitness benefits of different forms of exercise intervention : continuous/moderate intensity vs interval/alternating between low and vigorous intensity , and individual/neighborhood vs group/facility setting .


Initial design was a 6-month , 2 2 randomized trial of different exercise regimens in independently ambulatory patients with PD .


All arms were required to exercise 3 times per week , 45 minutes per session .


Randomization to group/facility setting was not feasible because of logistical factors .


Over the first 2 years , we randomized 43 participants to continuous or interval training .


Because preliminary analyses suggested higher musculoskeletal adverse events in the interval group and lack of difference between training methods in improving fitness , the next 17 participants were allocated only to continuous training .


Eighty-one percent of 60 participants completed the study with a mean attendance of 83.3 % ( 95 % confidence interval : 77.5 % -89.0 % ) , exercising at 46.8 % ( 44.0 % -49.7 % ) of their heart rate reserve .


There were no serious adverse events .


Across all completers , we observed improvements in maximum oxygen consumption , gait speed , Unified Parkinson 's Disease Rating Scale sections I and III scores ( particularly axial functions and rigidity ) , fatigue , depression , quality of life ( e.g. , psychological outlook ) , and flanker task scores ( p < 0.05 to p < 0.001 ) .


Increase in maximum oxygen consumption correlated with improvements on the flanker task and quality of life ( p < 0.05 ) .


Our preliminary study suggests that aerobic walking in a community setting is safe , well tolerated , and improves aerobic fitness , motor function , fatigue , mood , executive control , and quality of life in mild to moderate PD .


This study provides Class IV evidence that in patients with PD , an aerobic exercise program improves aerobic fitness , motor function , fatigue , mood , and cognition .


Irritable bowel syndrome ( IBS ) is characterized by heterogeneous pathophysiology and low response to treatment .


Up to 60 % of IBS patients suffers from visceral hypersensitivity , which is associated with symptom severity and underlying pathophysiological mechanisms .


Recently , positive effects of probiotics in IBS have been reported , but overall the response was modest .


We performed a study in IBS patients , characterized by visceral hypersensitivity measured with the rectal barostat , aiming to assess the effect of 6weeks of multispecies probiotic mix on visceral pain perception .


We conducted a randomized , placebo-controlled , double-blind trial in forty Rome III IBS patients with visceral hypersensitivity .


Prior to intake , patients kept a 2-week symptom diary and underwent a rectal barostat measurement .


When hypersensitivity was confirmed , participation was allowed and patients received a multispecies probiotic with in vitro proven potential beneficial effects on mechanisms contributing to visceral hypersensitivity ( six different probiotic strains ; 10 ( 9 ) cfu/g ) , or a placebo product of one sachet ( 5g ) per day for 6weeks .


At the end of the intervention period , visceroperception and symptoms were reassessed .


Thirty-five patients completed the trial .


The percentage of patients with visceral hypersensitivity decreased significantly in the probiotic and placebo group ( 76.5 % and 71.4 % , respectively ; N.S. between groups ) .


Improvement in pain scores and mean symptom score did not differ between the probiotic and placebo group .


In this placebo-controlled trial in IBS patients with visceral hypersensitivity , no significant effect of a multispecies probiotic on viscerperception was observed .


The study has been registered in the US National Library of Medicine ( http://www.clinicaltrials.gov , NCT00702026 ) .


The aim of this study was to determine the efficacy of real-time continuous glucose monitoring in T1D patients treated with insulin pump therapy or multiple daily insulin therapy .


Twenty adult patients ( ten insulin pump therapy and ten multiple daily insulin ) with poor glycaemic control ( HbA1c > 8.0 % ) were randomized into two groups for 6 months : the continuous glucose monitoring arm ( using real-time continuous glucose monitoring ) and the SMBG arm .


After 2 months of wash-out , the participants crossed over .


The primary outcome was HbA1c reduction .


The secondary outcomes were hypoglycaemia and hyperglycaemia risk assessment ( area under the curve < 70 mg/dL/day and AUC > 200 mg/dL/day , respectively ) and glucose variability .


Fourteen patients ( eight multiple daily insulin , six insulin pump therapy ) used continuous glucose monitoring appropriately ( at least 40 % of the time ) .


In these patients , the improvement in glycaemic control was more evident during the real-time continuous glucose monitoring period ( 7.76 % 0.4 vs 8.54 % 0.4 , p < 0.05 ) than during the self-monitoring of blood glucose period ( 8.42 % 0.4 vs 8.56 % 0.5 , p = 0.2 ) .


Better results with continuous glucose monitoring were observed in patients using multiple daily insulin with greater improvement in both glycaemic control ( 7.71 % 0.2 vs 8.58 % 0.2 , p < 0.05 ) and glucose variability and with a marked reduction in the risk of both hypoglycaemia and hyperglycaemia .


Appropriate use of real-time continuous glucose monitoring improved glycometabolic control in T1D patients .


The effects of continuous glucose monitoring were more evident in patients under multiple daily insulin treatment , compared with insulin pump therapy .


Glucose variability , in addition to glycaemic control , was improved in compliant diabetic patients .


Acute heart failure is a common reason for admission , and outcome is often poor .


Improved prognostic risk stratification may assist in the design of future trials and in patient management .


Using data from a large randomized trial , we explored the prognostic value of clinical variables , measured at hospital admission for acute heart failure , to determine whether a few selected variables were inferior to an extended data set .


The prognostic model included 37 clinical characteristics collected at baseline in PROTECT , a study comparing rolofylline and placebo in 2033 patients admitted with acute heart failure .


Prespecified outcomes at 30 days were death or rehospitalization for any reason ; death or rehospitalization for cardiovascular or renal reasons ; and , at both 30 and 180 days , all-cause mortality .


No variable had a c-index > 0.70 , and few had values > 0.60 ; c-indices were lower for composite outcomes than for mortality .


Blood urea was generally the strongest single predictor .


Eighteen variables contributed independent prognostic information , but a reduced model using only 8 items ( age , previous heart failure hospitalization , peripheral edema , systolic blood pressure , serum sodium , urea , creatinine , and albumin ) performed similarly .


For prediction of all-cause mortality at 180 days , the model c-index using all variables was 0.72 and for the simplified model , also 0.72 .


A few simple clinical variables measured on admission in patients with acute heart failure predict a variety of adverse outcomes with accuracy similar to more complex models .


However , predictive models were of only moderate accuracy , especially for outcomes that included nonfatal events .


Better methods of risk stratification are required .


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


Unique identifiers : NCT00328692 and NCT00354458 .


Exogenous glucagon-like peptide-1 ( GLP-1 ) inhibits eating in healthy , overweight , and diabetic subjects .


The GLP-1 receptor antagonist exendin ( 9-39 ) NH2 ( ex9-39 ) was used to further explore the role of GLP-1 as an endogenous satiation signal .


Two double-blind , 4-way crossover studies were performed , each of which included 10 healthy men .


In study A , subjects received an intravenous infusion of ex9-39 or saline plus an oral glucose preload and an intraduodenal infusion of saline or glucose for 60 min .


In study B , intravenous infusions were identical , but an oral mixed-liquid meal preload and a 60-min intraduodenal infusion of saline or oleic acid were administered .


Thirty minutes after oral preloads , subjects ate and drank ad libitum , and amounts ingested and the time to meal completion were quantified .


In addition , appetite and plasma GLP-1 , peptide YY ( PYY ) , insulin , glucagon , and blood glucose concentrations were measured .


In both studies , GLP-1 , PYY , and glucagon were substantially higher with intravenous ex9-39 than with intravenous saline ( P 0.001 ) .


Insulin was lower with intravenous ex9-39 during intraduodenal glucose ( P 0.05 ) .


The decrease in prospective food consumption and desire to eat during ad libitum eating after glucose ingestion was slightly attenuated ( P 0.05 and P 0.01 , respectively ) with ex9-39 .


However , with intravenous ex9-39 , food and fluid intakes and eating duration were not changed in either study .


GLP-1 receptor antagonism slightly modulates appetite during ad libitum eating , but food and fluid intakes and meal duration remain unchanged , suggesting that endogenous GLP-1 is a weak satiation signal .


However , concomitant substantial increases in plasma PYY and glucagon may counteract a desatiating effect of ex9-39 .


The effect of ex9-39 on PYY secretion supports an autoinhibitory feedback mechanism that controls L cell secretion ; the effect on insulin and glucagon confirms the role of GLP-1 in glycemic control through its action on pancreatic and cells .


Drug dependence is a major problem in our country and in international level .


Reality therapy is an internal control system that determines why and how to choose the options that are set for our lives .


This study aimed to investigate the effect of reality therapy on metacognition , stress and decline in hope in drug addicts .


This study is quasi-experimental study .


Samples were chosen convenient among 60 drug addicts in Jahrom in 2012 .


Samples were randomly divided into two groups ( each group = 30 ) of intervention and control groups .


Control group received usual care and experimental group received reality therapy .


Results revealed that there was significant difference between the mean scores of metacognition and hope before and after the intervention of experimental group ( p < 0.05 ) .


Also , there was statistically significant difference between the two groups from these two variables ( p < 0.05 ) .


but , Stress level was n't statistically different in two groups .


Reality therapy is a method that emphasizes the accountability and the current behavior of individuals .


Setting negative emotions , reality therapy promotes metacognition and , through increasing accountability to self-behavior improves hope .


We sought to test the efficacy of a sexual risk intervention for male clients of female sex workers ( FSWs ) and examine whether efficacy was moderated by syndemic risk .


From 2010 to 2014 , we conducted a 2-arm randomized controlled trial ( 60-minute , theory-based , safer sex intervention versus a didactic time-equivalent attention control ) that included 400 male clients of FSWs on the US-Mexico border with follow-up at 4 , 8 , and 12 months .


We measured 5 syndemic risk factors , including substance use and depression .


Primary outcomes were sexually transmitted infections incidence and total unprotected sex with FSWs .


Although participants in both groups became safer , there was no significant difference in behavior change between groups .


However , baseline syndemic risk moderated intervention efficacy .


At baseline , there was a positive association between syndemic risk and unprotected sex .


Then at 12 months , longitudinal analyses showed the association depended on intervention participation ( B = -0.71 ; 95 % confidence interval [ CI ] = -1.22 , -0.20 ; P = .007 ) .


Among control participants there still existed this modest association ( B = 0.36 ; 95 % CI = -0.49 , 1.22 ; P = .09 ) ; among intervention participants there was a significant negative association ( B = -0.35 ; 95 % CI = -0.63 , -0.06 ; P = .02 ) .


A brief intervention might attenuate syndemic risks among clients of FSWs .


Other populations experiencing syndemic problems may also benefit from such programs .


Despite preoperative anaemia treatment , a risk of postoperative anaemia remains .


This randomized , controlled study evaluated the efficacy of i.v. ferric carboxymaltose ( FCM ) as postoperative anaemia treatment after total knee arthroplasty ( TKA ) .


TKA patients with postoperative anaemia [ haemoglobin ( Hb ) 8.5-12 .0 g dl ( -1 ) ] without prior transfusions were randomly assigned to FCM [ 700-1000 mg iron ( according to calculate iron deficit on postoperative day 2 ) ] or ferrous glycine sulphate ( FS ; 100 mg iron daily from day 7 onwards ) and followed for Hb , iron status , quality-of-life ( EQ-5D ) , and performance ( 6 min walk test ) until day 30 .


Of 161 preoperatively non-anaemic patients , 122 ( 75.8 % ) developed anaemia after operation ( within 24 h ) and were enrolled in this study ( 60 FCM , 62 FS ) .


Hb substantially decreased until day 4 in both groups , and partly recovered by day 30 .


FCM-treated patients achieved Hb 12.0 g dl ( -1 ) more frequently ( 42.3 % vs 23.5 % ; P = 0.04 ) and showed a trend towards higher Hb increase from day 4 to day 30 [ +1.7 ( 1.2 ) vs +1.3 ( 1.0 ) ; P = 0.075 ] compared with FS-treated patients .


Patients with postoperative Hb < 10 g dl ( -1 ) experienced better Hb increase with FCM [ +2.4 ( 0.3 ) g dl ( -1 ) ] than FS [ +1.1 ( 0.4 ) g dl ( -1 ) ; P = 0.018 ] .


Patients being iron-deficient at enrolment ( 56.7 % ) had a higher Hb increase with FCM [ +1.9 ( 0.3 ) g dl ( -1 ) ] than FS [ +1.2 ( 0.2 ) g dl ( -1 ) ; P = 0.03 ] .


Total EQ-5D and performance outcomes were comparable between the groups , but FCM was associated with better scores for ` usual activities ' .


No i.v. iron-related adverse events were reported .


Preoperatively non-anaemic TKA patients are at high risk of postoperative anaemia .


Postoperative i.v. FCM provided significant benefit over oral FS , particularly in patients with preoperative iron deficiency , severe postoperative anaemia , or both .


EudraCT 2010-023038-22 ; ClinicalTrials.gov NCT01913808 .


To compare the efficacy of gradient and swim-up semen preparation techniques on pregnancy rates in couples undergoing intrauterine insemination ( IUI ) cycles with low dose gonadotropin stimulation with the diagnosis of unexplained or mild male subfertility .


Two hundred and twenty three couples were randomized into swim up or gradient technique groups for sperm preperation .


The clinical and on going pregnancy rates per cycle and per patient were evaluated .


Both clinical and ongoing pregnancy rates per cycle were significantly higher in the `` gradient '' group ( 19 % and 16.9 % ) in comparision with the `` swim up '' group ( 9.7 % and 6.9 % ) ( p < 0.05 ) .


Clinical pregnancy and on-going pregnancy rates per patient were higher in the `` gradient '' group ( 26.1 % and 23.4 % ) when compared to the `` swim up '' group ( 15.2 % and 10.7 % ) , ( p < 0.05 ) .


In the subgroup of 191 unexplained subfertile couples with 290 cycles ; the `` gradient '' group also revealed significantly higher clinical and ongoing pregnancy rates per cycle ( 21.6 % and 17.9 % ) when compared with the `` swim up '' group ( 10.3 % and 7.1 % ) ( p < 0.05 ) .


In total of 48 treatment cycles upon 32 couples with mild male factor subfertility no significant difference were found between the two sperm preparation techniques in terms of clinical ( % 5.3 vs % 6.9 , p > 0.05 ) and ongoing ( % 5.3 vs % 6.9 , p > 0.05 ) pregnancy rates per cycle .


The gradient technique significantly improves clinical outcome in IUI cycles of unexplained subfertile couples when compared to swim up technique .


In male subfertile patients , both techniques yield similar clinical outcomes .


The factors influencing the decision making of operative treatment for fractures of the proximal humerus are debated .


We hypothesized that there is no difference in treatment recommendations between surgeons shown radiographs alone and those shown radiographs and patient information .


Secondarily , we addressed ( 1 ) factors associated with a recommendation for operative treatment , ( 2 ) factors associated with recommendation for arthroplasty , ( 3 ) concordance with the recommendations of the treating surgeons , and ( 4 ) factors affecting the inter-rater reliability of treatment recommendations .


A total of 238 surgeons of the Science of Variation Group rated 40 radiographs of patients with proximal humerus fractures .


Participants were randomized to receive information about the patient and mechanism of injury .


The response variables included the choice of treatment ( operative vs nonoperative ) and the percentage of matches with the actual treatment .


Participants who received patient information recommended operative treatment less than those who received no information .


The patient information that had the greatest influence on treatment recommendations included age ( 55 % ) and fracture mechanism ( 32 % ) .


The only other factor associated with a recommendation for operative treatment was region of practice .


There was no significant difference between participants who were and were not provided with information regarding agreement with the actual treatment ( operative vs nonoperative ) provided by the treating surgeon .


Patient information-older age in particular-is associated with a higher likelihood of recommending nonoperative treatment than radiographs alone .


Clinical information did not improve agreement of the Science of Variation Group with the actual treatment or the generally poor interobserver agreement on treatment recommendations .


Cobicistat ( COBI ) is a pharmacoenhancer with no antiretroviral activity .


International , randomized double-blind active-controlled trial to evaluate the efficacy and safety of COBI vs ritonavir ( RTV ) as a pharmacoenhancer of atazanavir in combination with emtricitabine/tenofovir disoproxil fumarate in HIV treatment-naive patients followed through week 144 .


At Week 144 , virologic suppression was achieved in 72 % ( COBI ) and 74 % ( RTV ) of patients .


Adverse events leading to study drug discontinuation occurred in 11 % of patients in each group .


Median changes in serum creatinine ( mg/dL ) were +0.13 ( COBI ) and +0.07 ( RTV ) and were unchanged from week 48 .


Once-daily COBI is a safe and effective pharmacoenhancer of the protease inhibitor atazanavir .


To evaluate the efficacy of intermittent percutaneous needle sacral nerve stimulation ( IPN-SNS ) in women with idiopathic overactive bladder ( IOAB ) treated with tolterodine .


A total of 240 female patients diagnosed with IOAB were randomized to receive tolterodine only treatment ( group 1 , n = 120 ) or tolterodine combined with IPN-SNS ( group 2 , n = 120 ) .


Each group included 120 participants , who were divided into subgroups depending on whether they had dry OAB ( urinary frequency and urgency ) or wet OAB ( urinary frequency and urgency with urgency incontinence ) .


In the treatment group , patients received percutaneous IPN-SNS plus tolterodine ( 2 mg once daily ) , while in the control group , only tolterodine ( 2 mg once daily ) was administered for 3 months .


The voiding diary and urodynamic parameters were monitored , and patients ' psychological depression and anxiety scores were recorded before and after treatment .


There were significantly greater improvements in the conditions of first desire to void ( FDV ) , maximum cystometric capacity ( MCC ) , and daily average volumes , as well as the daily single maximum voided volumes in group 2 ( P = .001 ) than in group 1 .


In addition , there were significantly greater decreases in self-rating depression scale ( SDS ) and self-rating anxiety scale ( SAS ) scores in group 2 compared with group 1 ( P < .001 ) .


Combined treatment with tolterodine plus IPN-SNS can not only improve the symptoms of voiding dysfunction but can also reduce the concomitant depression and anxiety in women with IOAB , thereby improving patients ' quality of life .


To determine if high-intensity , task-oriented , visual feedback training with a video game balance board ( Nintendo Wii ) induces significant changes in diffusion-tensor imaging ( DTI diffusion-tensor imaging ) parameters of cerebellar connections and other supratentorial associative bundles and if these changes are related to clinical improvement in patients with multiple sclerosis .


The protocol was approved by local ethical committee ; each participant provided written informed consent .


In this 24-week , randomized , two-period crossover pilot study , 27 patients underwent static posturography and brain magnetic resonance ( MR ) imaging at study entry , after the first 12-week period , and at study termination .


Thirteen patients started a 12-week training program followed by a 12-week period without any intervention , while 14 patients received the intervention in reverse order .


Fifteen healthy subjects also underwent MR imaging once and underwent static posturography .


Virtual dissection of white matter tracts was performed with streamline tractography ; values of DTI diffusion-tensor imaging parameters were then obtained for each dissected tract .


Repeated measures analyses of variance were performed to evaluate whether DTI diffusion-tensor imaging parameters significantly changed after intervention , with false discovery rate correction for multiple hypothesis testing .


There were relevant differences between patients and healthy control subjects in postural sway and DTI diffusion-tensor imaging parameters ( P < .05 ) .


Significant main effects of time by group interaction for fractional anisotropy and radial diffusivity of the left and right superior cerebellar peduncles were found ( F2 ,23 range , 5.555-3 .450 ; P = .036 -.088 after false discovery rate correction ) .


These changes correlated with objective measures of balance improvement detected at static posturography ( r = -0.381 to 0.401 , P < .05 ) .


However , both clinical and DTI diffusion-tensor imaging changes did not persist beyond 12 weeks after training .


Despite the low statistical power ( 35 % ) due to the small sample size , the results showed that training with the balance board system modified the microstructure of superior cerebellar peduncles .


The clinical improvement observed after training might be mediated by enhanced myelination-related processes , suggesting that high-intensity , task-oriented exercises could induce favorable microstructural changes in the brains of patients with multiple sclerosis .


To explore the effectiveness of the color Doppler ultrasound-guided botulinum toxin type A ( BTX-A ) injection combined with an ankle foot brace ( AFO ) for treating lower limb spasticity after a stroke .


A total of 103 post-stroke patients with lower limb spasticity were divided into three groups : the control group treated with conventional therapy and rehabilitation training , the observation group treated with conventional therapy , rehabilitation training and botulinum toxin type A injection , the treatment group treated with AFO plus the same treatment received by the observation group .


The muscle spasms were evaluated using the Clinic Spasticity Influx ( CSI ) , movement with the Fugl-Meyer Assessment ( FMA ) , dynamic and static balance with the Berg Balance Scale ( BBS ) , and daily life activities with the Functional Independence Measure ( FIM ) , respectively .


Compared the first month after treatment with the prior treatment , there were significant differences in CSI , FMA and FIM scores in both control group and the observation group ( p < 0.05 ) .


However , no differences were noticed in the control group ( p > 0.05 ) .


Compared the third and sixth month after treatment with prior treatment , there were significant differences in these three groups ( p < 0.05 ) .


In terms of treatment time , the BBS scores were always higher in all three groups after one month , three months and six months treatment than prior treatment ( p < 0.05 ) , and there were significant differences in third month and sixth month after treatment compared with the first month treatment ( p < 0.05 ) .


Compared the third month after treatment with the sixth month , there were significant differences in all three groups ( p < 0.05 ) .


The color Doppler ultrasound-guided BTX-A injection combined with AFO can effectively promote patients with post-stroke lower limb spasticity in lower limb muscle spasm , movement , balance and daily life activities .


Previous efforts to preserve cell function in individuals with type 1 diabetes ( T1D ) have focused largely on the use of single immunomodulatory agents administered within 100 days of diagnosis .


Based on human and preclinical studies , we hypothesized that a combination of low-dose anti-thymocyte globulin ( ATG ) and pegylated granulocyte CSF ( G-CSF ) would preserve cell function in patients with established T1D ( duration of T1D > 4 months and < 2 years ) .


A randomized , single-blinded , placebo-controlled trial was performed on 25 subjects : 17 subjects received ATG ( 2.5 mg/kg intravenously ) followed by pegylated G-CSF ( 6 mg subcutaneously every 2 weeks for 6 doses ) and 8 subjects received placebo .


The primary outcome was the 1-year change in AUC C-peptide following a 2-hour mixed-meal tolerance test ( MMTT ) .


At baseline , the age ( mean SD ) was 24.6 10 years ; mean BMI was 25.4 5.2 kg/m ; mean A1c was 6.5 % 1.1 % ; insulin use was 0.31 0.22 units/kg/d ; and length of diagnosis was 1 0.5 years .


Combination ATG/G-CSF treatment tended to preserve cell function in patients with established T1D .


The mean difference in MMTT-stimulated AUC C-peptide between treated and placebo subjects was 0.28 nmol/l/min ( 95 % CI 0.001-0 .552 , P = 0.050 ) .


A1c was lower in ATG/G-CSF-treated subjects at the 6-month study visit .


ATG/G-CSF therapy was associated with relative preservation of Tregs .


Patients with established T1D may benefit from combination immunotherapy approaches to preserve cell function .


Further studies are needed to determine whether such approaches may prevent or delay the onset of the disease .


Clinicaltrials.gov NCT01106157 .


The Leona M. and Harry B. Helmsley Charitable Trust and Sanofi .


To test the hypothesis that colchicine use during early disease decreases immunosuppressive use in Behet syndrome ( BS ) in the long term .


Patients with BS who participated in a double-blind , placebo-controlled trial of colchicine 16.61.1 years ago were evaluated for immunosuppressive use during the posttrial period .


We could contact 90/116 patients ; 28 ( 31 % ) received immunosuppressives during the posttrial period , 14 being from the colchicine arm .


Posttrial colchicine use and cumulative duration were similar between patients who received immunosuppressives and those who did not .


Continuous use of colchicine , even when initiated at an early disease stage , does not seem to decrease the use of immunosuppressives in the long term .


Feeding polyphenol-rich plant products has been shown to increase the gain : feed ratio in growing pigs .


The reason for this finding has not yet been elucidated .


In order to find the reasons for an increase of the gain : feed ratio , this study investigated the effect of two polyphenol-rich dietary supplements , grape seed and grape marc meal extract ( GSGME ) or spent hops ( SH ) , on gut morphology , apparent digestibility of nutrients , microbial composition in faeces and the expression of pro-inflammatory genes in the intestine of pigs .


Pigs fed GSGME or SH showed an improved gain : feed ratio in comparison to the control group ( P < 0.10 for GSGME , P < 0.05 for SH ) .


Villus height : crypt depth ratio in duodenum and jejunum as well as apparent total tract digestibility of nutrients were unchanged in the groups receiving GSGME or SH in comparison to the control group .


However , the groups receiving GSGME or SH revealed an increased faecal pH value , lower levels of volatile fatty acids and lower counts of Streptococcus spp .


and Clostridium Cluster XIVa in the faecal microbiota ( P < 0.05 ) .


Moreover , both treatment groups had a lower expression of various pro-inflammatory genes in duodenum , ileum and colon than the control group ( P < 0.05 ) .


The present study suggests that dietary plant products rich in polyphenols are able to improve the gain : feed ratio in growing pigs .


It is assumed that an alteration in the microbial composition and anti-inflammatory effects of the polyphenol-rich plant products in the intestine might contribute to this effect .


Accuracy of the radiologic diagnosis of gastric cancer staging after neoadjuvant chemotherapy remains unclear .


Patients enrolled in the COMPASS trial , a randomized phase II study comparing two and four courses of S-1 plus cisplatin and paclitaxel and cisplatin followed by gastrectomy , were examined .


The radiologic stage was determined by using thin-slice computed tomography ( CT ) or multidetector low CT by following Habermann 's method .


A total of 75 patients registered in the COMPASS study who underwent surgical resection were examined in this study .


The radiologic T and pathologic T stages were not significantly correlated ( p = 0.221 ) .


The radiologic accuracy and rates of underdiagnosis and overdiagnosis were 42.7 , 10.7 , and 46.7 % , respectively .


When patients were stratified according to the pathologic response of the primary tumor , the correlation was not significant in either the responders ( n = 32 , p = 0.410 ) or the nonresponders ( n = 43 , p = 0.742 ) .


The radiologic accuracy was 37.5 % in the responders and 42.7 % in the nonresponders .


The radiologic N and pathologic N stages were significantly correlated ( p = 0.000 ) .


The radiologic accuracy and rates of underdiagnosis and overdiagnosis were 44 , 29.3 , and 26.7 % , respectively .


When stratifying the patients with measurable lymph nodes according only to the radiologic response , the correlation was significant in the nonresponders ( n = 23 , p = 0.035 ) but not in the responders ( n = 28 , p = 0.634 ) .


The radiologic accuracy was 39.3 % in the responders and 52.1 % in the nonresponders .


Restaging using CT after neoadjuvant chemotherapy for gastric cancer is considered to be inaccurate and unreliable .


In particular , the radiologic T-staging determined after neoadjuvant chemotherapy should not be considered in clinical decision-making .


Most randomized trials have shown similar results with endoscopic carpal tunnel release ( ECTR ) and open carpal tunnel release ( OCTR ) ; however , there are studies suggesting less postoperative pain , faster improvement in grip and pinch strength , and earlier return to work with the endoscopic technique .


The goal of this study was to prospectively examine subjective and functional outcomes , satisfaction , and complications after both ECTR and OCTR in the opposite hands of the same patient , serving as their own control .


This was a prospective , randomized study in which patients underwent surgery for bilateral carpal tunnel syndrome .


The first carpal tunnel release was performed on the most symptomatic hand-determined by the patient .


Operative approach was randomly assigned and , approximately 1 month later , the alternative technique was performed on the contralateral side .


Demographic data were obtained , and functional outcomes were recorded preoperatively and postoperatively , including pain score , 2-point discrimination , Semmes-Weinstein monofilament testing , thenar strength , and overall grip strength .


The carpal tunnel syndrome-functional status score and carpal tunnel syndrome-symptom severity score were recorded before surgery and at 2 , 4 , 8 , 12 , and 24 weeks postoperatively .


Overall satisfaction with each technique was recorded at the conclusion of the study .


Currently , 25 subjects have completed final visit testing .


There were no differences in pain score , 2-point discrimination , Semmes-Weinstein monofilament testing , thenar strength , or overall grip strength at any of the postoperative time points .


Carpal tunnel syndrome-symptom severity score and carpal tunnel syndrome-functional status score were not significantly different between groups at any of the evaluations .


Overall satisfaction , where patients recorded a number from 0 to 100 , was significantly greater in the ECTR group ( 95.95 vs 91.60 , P = 0.04 ) .


There were no complications with either technique .


This interim analysis , using the same patient as an internal control , suggests that both OCTR and ECTR are well tolerated with no differences in functional outcomes , symptom severity and functional status questionnaires , or complications .


Although there were no differences between groups using our study metrics , patients still preferred the ECTR , demonstrated by significantly higher overall satisfaction scores at the conclusion of the study .


To evaluate the 24-month efficacy and safety of intravitreal ranibizumab 0.5 mg and 2.0 mg administered monthly or as needed ( pro re nata [ PRN ] ) in patients with neovascular age-related macular degeneration ( wet AMD ) .


Twenty-four-month , multicenter , randomized , double-masked , active treatment-controlled phase 3 trial .


Patients ( n = 1098 ) 50 years of age with treatment-nave subfoveal wet AMD .


Patients were randomized to receive intravitreal injections of ranibizumab 0.5 mg or 2.0 mg monthly or PRN after 3 monthly loading doses .


The primary efficacy end point was the mean change in best-corrected visual acuity ( BCVA ) from baseline at month 12 .


Key secondary end points included mean change in BCVA from baseline at month 24 , proportion of patients who gained 15 letters in BCVA , mean number of ranibizumab injections , and mean change in central foveal thickness from baseline over time by spectral-domain optical coherence tomography .


Ocular and systemic safety events also were evaluated through month 24 .


At month 24 , the mean change from baseline in BCVA was ( letters ) +9.1 ( 0.5 mg monthly ) , +7.9 ( 0.5 mg PRN ) , +8.0 ( 2.0 mg monthly ) , and +7.6 ( 2.0 mg PRN ) .


The change in mean BCVA from month 12 to 24 was ( letters ) -1.0 , -0.3 , -1.2 , and -1.0 , respectively .


The proportion of patients who gained 15 letters from baseline in BCVA at month 24 was 34.5 % , 33.1 % , 37.6 % , and 34.8 % , respectively .


The mean number of ranibizumab injections through month 24 was 21.4 , 13.3 , 21.6 , and 11.2 , respectively ; 5.6 and 4.3 mean injections were required in year 2 in the 0.5 mg and 2.0 mg PRN groups , respectively .


The average treatment interval in the 0.5 mg PRN group was 9.9 weeks after 3 monthly loading doses , and 93 % of these patients did not require monthly dosing .


Ocular and systemic safety profiles over 2 years were similar among all 4 treatment groups and were consistent with previous ranibizumab trials in AMD .


At month 24 , mean BCVA improvements were clinically meaningful and similar among all 4 ranibizumab treatment groups .


The 0.5 mg PRN group achieved a mean gain of 7.9 letters at month 24 with an average of 13.3 injections ( 5.6 injections in year 2 ) .


No new safety events were identified over 24 months .


Lifestyle modification is recommended for management of prehypertension , yet finding effective interventions to reach rural women is a public health challenge .


This community-based clinical trial compared the effectiveness of standard advice to two multi-component theory-based tailored interventions , using web-based or print-mailed delivery , in reducing blood pressure among rural women , ages 40-69 , with prehypertension .


289 women with prehypertension enrolled in the Wellness for Women : DASHing towards Health trial , a 12-month intervention with 12-month follow-up .


Women were randomly assigned to groups using a 1:2:2 ratio , comparing standard advice ( 30-minute counseling session ) to two interventions ( two 2-hour counseling sessions , 5 phone goal-setting sessions , strength-training video , and 16 tailored newsletters , web-based or print-mailed ) .


Linear mixed model methods were used to test planned pairwise comparisons of marginal mean change in blood pressure , healthy eating and activity , adjusted for age and baseline level .


General estimating equations were used to examine the proportion of women achieving normotensive status and meeting health outcome criteria for eating and activity .


Mean blood pressure reduction ranged from 3.8 ( SD = 9.8 ) mm Hg to 8.1 ( SD = 10.4 ) mm Hg .


The 24-month estimated marginal proportions of women achieving normotensive status were 47 % for web-based , and 39 % for both print-mailed and standard advice groups , with no group differences ( p = .11 and p = .09 , respectively ) .


Web-based and print-mailed groups improved more than standard advice group for waist circumference ( p = .017 and p = .016 , respectively ) ; % daily calories from fat ( p = .018 and p = .030 ) and saturated fat ( p = .049 and p = .013 ) ; daily servings of fruit and vegetables ( p = .008 and p < .005 ) ; and low fat dairy ( p < .001 and p = .002 ) .


Greater improvements were observed in web-based versus standard advice groups in systolic blood pressure ( p = .048 ) and estimated VO2max ( p = .037 ) .


Dropout rates were 6 % by 6-months , 11.4 % by 24 months , with no differences across groups .


Rural women with prehypertension receiving distance-delivery theory-based lifestyle modifications can achieve a reduction of blood pressure and attainment of normotensive status .


ClinicalTrials.gov NCT00580528 .


To investigate the safety and efficacy of trastuzumab administered concurrently with anthracycline-containing adjuvant regimen for breast cancer .


It is a prospective , randomized and controlled trial .


Participants were randomized to receive trastuzumab administered concurrently or sequentially with anthracycline-containing adjuvant regimen .


The primary endpoint was cardiac safety .


The second endpoints were disease-free survival ( DFS ) and overall survival ( OS ) .


One hundred and nine breast cancer patients were enrolled and randomized in this trial .