A total of 142 parents were recruited , with 72 parents randomly assigned to the experimental group and 70 to the control group .


Harsh parenting practices , parent-child relationships and parental stress were assessed .


In comparison to parents in the control group , those in the experimental group engaged in less harsh parenting practices and reported better parent-child relationships .


However , parental stress scores did not differ significantly between the two groups .


This study addressed a gap in the literature by examining the effectiveness of the training programme for enhancing parent-child relationship and decreasing parental stress at the time of a child 's transition to primary school .


The findings from this study provide empirical evidence of the effectiveness of the parental training programme and highlight the significance of parenting in promoting a smooth transition for children from kindergarten to primary 1 .


ClinicalTrials.gov : NCT01845948 .


Postpartum depression ( PPD ) and poor childbirth outcomes are associated with poverty ; these variables should be addressed by an adapted approach .


The aim of this research was to evaluate the impact of an antenatal programme based on a novel psychosomatic approach to pregnancy and delivery , regarding the risk of PPD and childbirth outcomes in disadvantaged women .


A multi-centre , randomized , controlled trial comparing a novel to standard antenatal programme .


Primary outcome was depressive symptoms ( using EPDS ) and secondary outcome was preterm childbirth ( fewer 37 weeks ) .


The sample comprised 184 couples in which the women were identified to be at PPD risk by validated interview .


The study was conducted in three public hospitals with comparable standards of perinatal care .


Women were randomly distributed in to an experimental group ( EG ) or a control group ( CG ) , and evaluated twice : during pregnancy ( T1 ) and four weeks post-partum ( T2 ) .


At T2 , the variables were compared using the chi square test .


Data analysis was based on intention to treat .


The novel programme used the Tourn psychosomatic approach focusing on body awareness sensations , construction of an individualized childbirth model , and attachment .


The 10 group antenatal sessions each lasted two hours , with one telephone conversation between sessions .


In the control group , the participants choose the standard model of antenatal education , i.e. , 8 to 10 two-hour sessions focused on childbirth by obstetrical prophylaxis .


A difference of 11.2 % was noted in postpartum percentages of PPD risk ( EPDS 12 ) : 34.3 % ( 24 ) in EG and 45.5 % ( 27 ) in CG ( p = 0.26 ) .


The number of depressive symptoms among EG women decreased at T2 ( intragroup p = 0.01 ) .


Premature childbirth was four times less in EG women : three ( 4.4 % ) compared to 13 ( 22.4 % ) among CG women ( p = 0.003 ) .


Birth weight was higher in EG women ( p = 0.01 ) .


The decrease of depressive symptoms in women was not conclusive .


However , because birth weight was higher and the rate of preterm childbirth was lower in the EG , our results suggest that the psychosomatic approach may be more helpful to the target population than the standard antenatal programs .


To evaluate the effects of canrenone compared to placebo on blood pressure control , some non-conventional biomarkers in cardiovascular stratification , and on metalloproteinases in patients affected by metabolic syndrome .


A total of 156 Caucasian patients were treated with placebo or canrenone , 50 mg once a day , for 3 months and then 50 mg twice a day , till the end of the study .


We evaluated : systolic ( SBP ) and diastolic blood pressure ( DBP ) , body weight , body mass index ( BMI ) , fasting plasma glucose ( FPG ) , lipid profile , plasma aldosterone , creatinine , potassium , brain natriuretic peptide ( BNP ) , metalloproteinases 2 and 9 ( MMP-2 and -9 ) , lipoprotein ( a ) ( Lp ( a ) ) , and serum myeloperoxidase ( MPO ) .


We observed a significant decrease of SBP and DBP in the canrenone group compared to baseline .


Canrenone gave a significant decrease of MMP-2 and -9 , Lp ( a ) , and MPO compared to baseline , not observed with placebo .


Plasma aldosterone , but not BNP , decreased with canrenone , both compared to baseline and to placebo .


Canrenone seems to be effective in reducing blood pressure in patients with metabolic syndrome .


Moreover , canrenone seems also to improve MPO , Lp ( a ) , and metalloproteinases in these patients .


Health promotion at the work site in terms of physical activity has proven positive effects but optimization of relevant exercise training protocols and implementation for high adherence are still scanty .


The aim of this paper is to present a study protocol with a conceptual model for planning the optimal individually tailored physical exercise training for each worker based on individual health check , existing guidelines and state of the art sports science training recommendations in the broad categories of cardiorespiratory fitness , muscle strength in specific body parts , and functional training including balance training .


The hypotheses of this research are that individually tailored worksite-based intelligent physical exercise training , IPET , among workers with inactive job categories will : 1 ) Improve cardiorespiratory fitness and/or individual health risk indicators , 2 ) Improve muscle strength and decrease musculoskeletal disorders , 3 ) Succeed in regular adherence to worksite and leisure physical activity training , and 3 ) Reduce sickness absence and productivity losses ( presenteeism ) in office workers .


The present RCT study enrolled almost 400 employees with sedentary jobs in the private as well as public sectors .


The training interventions last 2 years with measures at baseline as well as one and two years follow-up .


If proven effective , the intelligent physical exercise training scheduled as well as the information for its practical implementation can provide meaningful scientifically based information for public health policy .


ClinicalTrials.gov , number : NCT01366950 .


This phase I study assessed the pharmacokinetic ( PK ) , tolerability , safety and preliminary clinical activity of tamoxifen ( T ) and lapatinib ( L ) in patients with metastatic breast cancer ( MBC ) .


Patients ( pts ) with hormone receptor positive MBC , irrespective of HER-2 status , were randomly assigned to T T + L group , tamoxifen in cycle 1 for 28 days then adding lapatinib on day 1 of cycle 2 ; or L T + L group , lapatinib in cycle 1 for 14 days , then adding tamoxifen on day 1 of cycle 2 to evaluate the potential drug-drug PK interaction at steady-state .


The dose of tamoxifen was 20 mg/day and lapatinib 1500 mg/day .


Twenty-five pts were enrolled of which 23 started treatment , five ( 22 % ) of them were HER-2 positive .


Median age was 59 years and 96 % had PS 1 .


Eleven ( 91.7 % ) pts in the T T + L group and 10 ( 76.9 % ) in L T + L group received at least 2 cycles of treatment .


The most frequently reported drug-related adverse events ( > 25 % of patients ) were diarrhoea ( 62 % ) , anaemia ( 56 % ) , rash ( 52 % ) , fatigue ( 52 % ) , dermatology other ( 34 % ) and leukopenia ( 28 % ) .


Grade 3-4 drug-related toxicities were infrequent ( < 10 % ) .


No cardiotoxicity was observed .


T plasma concentrations did not appeared to be affected by the presence of lapatinib .


L steady-state plasma concentrations were 20 % lower after 28 days of co-administration with T. Eight ( 36.4 % ) patients experienced stable disease and median progression free survival was 2.7 months .


The combination of L and T was safe and clinically active .


T affected L plasma concentrations , which remained within the therapeutic index .


Repeated-measures , crossover , double-blinded randomized controlled trial .


To compare the immediate effectiveness of 2 types of counterforce braces in improving pain-free grip strength , pressure pain threshold , and wrist angle during a gripping task in individuals with lateral epicondylalgia .


Sports medicine management of lateral epicondylalgia often includes application of a counterforce brace , but the comparative effectiveness of different braces is unclear .


The most common brace design consists of a single strap wrapped around the proximal forearm .


A variation of this brace is the use of an additional strap that wraps above the elbow , which aims to provide further unloading to the injured tissue .


Pain-free grip strength , pressure pain threshold , and wrist angle during a gripping task were measured on 34 participants with a clinical diagnosis of lateral epicondylalgia ( mean SD age , 47.8 8.5 years ) .


Measurements were made without a brace , as well as immediately before and after the application of 2 types of counterforce braces .


Each condition was tested during a separate session , with a minimum of 48 hours between sessions .


Analysis-of-variance models were used to test the differences within and between conditions .


Pain-free grip strength ( 17.2 N ; 95 % confidence interval : 7.5 , 26.8 ) and pressure pain threshold ( 42.2 kPa ; 95 % confidence interval : 16.5 , 68.0 ) significantly improved on the affected side immediately following the intervention conditions as well as the control condition .


There was no significant difference between braces or the control condition for any outcome .


Both types of counterforce braces had an immediate positive effect in participants with lateral epicondylalgia , without differences between interventions and similar to a no-brace control condition .


Therefore , while the use of a brace may be helpful in managing immediate symptoms related to lateral epicondylalgia , the choice of which brace to use may be more a function of patient preference , comfort , and cost .


Further research is required to investigate the comparative longer-term and clinical effects of the 2 braces .


ACTRN12609000354280 ( www.anzctr.org.au ) .


The issue of osteoporosis-induced fractures has attracted the world 's attention .


Postmenopausal women are particularly at risk for this type of fracture .


The nonmedicinal intervention for postmenopausal women is mainly exercise .


Whole body vibration ( WBV ) is a simple and convenient exercise .


There have been some studies investigating the effect of WBV on osteoporosis ; however , the intervention models and results are different .


This study mainly investigated the effect of high-frequency and high-magnitude WBV on the bone mineral density ( BMD ) of the lumbar spine in postmenopausal women .


This study randomized 28 postmenopausal women into either the WBV group or the control group for a 6-month trial .


The WBV group received an intervention of high-frequency ( 30 Hz ) and high-magnitude ( 3.2 g ) WBV in a natural full-standing posture for 5 minutes , three times per week , at a sports center .


Dual-energy X-ray absorptiometry was used to measure the lumbar BMD of the two groups before and after the intervention .


Six months later , the BMD of the WBV group had significantly increased by 2.032 % ( P = 0.047 ) , while that of the control group had decreased by 0.046 % ( P = 0.188 ) .


The comparison between the two groups showed that the BMD of the WBV group had increased significantly ( P = 0.016 ) .


This study found that 6 months of high-frequency and high-magnitude WBV yielded significant benefits to the BMD of the lumbar spine in postmenopausal women , and could therefore be provided as an alternative exercise .


To explore correlation between lung and large intestine and the two meridians under pathological condition in the view of meridian theory .


Ninety-six cases of bronchial asthma were applied palpation at the running course of 12 regular meridians under the elbow and knees and back-shu points .


And abnormal reactions were recorded , the affected meridians and back-shu points were discovered .


The abnormal reactions most frequently appeared on the Lung Meridian , followed by the Large Intestine Meridian , the Spleen Meridian , the Liver Meridian , the Stomach Meridian and the Triple Energizer Meridian .


And the unusual reaction of the back-shu points most frequently appeared on Feishu ( BL 13 ) , and Dachangshu ( BL 25 ) and Pishu ( BL 21 ) followed as the next two .


The existence of correlation between the Lung Meridian and the Large Intestine Meridians under pathological condition can be proved through meridian and acupoint palpation on bronchial asthma patients .


Catheter ablation of atrial fibrillation ( AF ) is a physically demanding procedure for the operator , involving radiation exposure , and has limited success rates .


Remote robotic navigation ( RRN ) may offer benefit to the procedure , though only 1 previous small randomized trial has assessed this .


This study aimed to investigate the impact of RRN on 1-year single-procedure success rates .


RRN was compared to manual ablation in a randomized control trial setting by using an intention-to-treat analysis .


A total of 157 patients underwent ablation ( 116/157 ( 74 % ) persistent AF ; 67/116 ( 58 % ) of these long-standing persistent AF ) .


There were no significant differences between the RRN and manual groups with respect to 1-year single-procedure success rates ( 19/78 ( 24 % ) and 26/78 ( 33 % ) , respectively ; P = .29 ) , acute wide area circumferential ablation reconnection rates , complication rates , or procedure times .


On multivariable analysis , fluoroscopy times were significantly shorter in the RRN group .


The number of catheter displacements during ablation was lower in the RRN group , as was subjectively assessed operator fatigue .


The crossover rate from RRN to manual ablation was 11/78 ( 14 % ) , mainly secondary to technical problems with the RRN system .


A learning curve was evident for RRN ablation : the fluoroscopy and procedure times were significantly lower after the first 10 cases in an operator 's experience .


This randomized trial showed no difference in the success rate for catheter ablation of AF between a RRN and manual approach .


The results highlight the learning curve for RRN ablation and suggest that the use of this technology leads to an improvement in fluoroscopy times , catheter stability , and operator fatigue .


We aimed to examine the association between daily protein intake ( DPI ) and outcomes in patients from the Randomized Evaluation of Normal versus Augmented Level ( RENAL ) trial .


We analyzed the association between DPI and clinical outcomes using multivariable logistic regression , Cox proportional hazards models and time-adjusted analysis .


During ICU stay , mean DPI was 37.6 g/day among survivors and 37.7 g/day among nonsurvivors ( p = 0.96 ; DPI of 0.5 g/kg/day ) .


Only 159 ( 10.9 % ) of the patients received a mean DPI of > 1 g/kg .


Patients with a DPI above the median had a 43.1 % mortality compared with 46.1 % for a DPI below the median ( p = 0.25 ) .


On multivariate analysis , a lower DPI was not associated with increased odds ratios for 90-day mortality or any secondary outcomes .


Cox proportional hazards models and time-adjusted analysis confirmed these findings .


In the RENAL study , mean DPI was low .


Within the confines of such low DPI , greater amounts of DPI were not independently associated with improved clinical outcomes .


Video Journal Club `` Cappuccino with Claudio Ronco '' at www.karger.com/?doi=363175 .


The implantable cardioverter defibrillator ( ICD ) is better than antiarrhythmic drug therapy for the primary and secondary prevention of all-cause mortality and sudden cardiac death in patients with either coronary artery disease or idiopathic dilated cardiomyopathy .


This study aims to assess whether the ICD also has this effect for primary prevention in chronic Chagas cardiomyopathy ( CCC ) .


In this randomized ( concealed allocation ) open-label trial , we aim to enroll up to 1,100 patients with CCC , a Rassi risk score for death prediction of 10 points , and at least 1 episode of nonsustained ventricular tachycardia on a 24-hour Holter monitoring .


Patients from 28 centers in Brazil will be randomly assigned in a 1:1 ratio to receive an ICD or amiodarone ( 600 mg/d for 10 days , then 200-400 mg/d until the end of the study ) .


The randomization sequence will be generated by computer , and the members of the committees responsible for end point validation and data analysis will be blinded to study assignment .


The primary end point is all-cause death , and enrolment will continue until 256 patients have reached this end point .


Key secondary end points include cardiovascular death , sudden cardiac death , hospitalization for heart failure , and quality of life .


We expect follow-up to last 3 to 6 years , and data analysis will be done on an intention-to-treat basis .


This trial is registered with ClinicalTrials.gov number NCT01722942 .


CHAGASICS is the first large-scale trial to assess the benefit of ICD therapy for the primary prevention of death in patients with CCC and nonsustained ventricular tachycardia , who have a moderate to high risk of death .


The efficacy , acceptability and tolerability of the new oral phosphate binder Lenziaren ( SBR759 ) were evaluated in a randomized parallel-group design study in 36 healthy cats ( n = 6 per group ) .


Five groups were fed once daily with a commercial diet containing 0.2 % phosphorus ( `` standard diet '' ) into which was mixed Lenziaren at 0.25 , 0.5 , 1.0 or 2.0 g/day or no treatment ( control group ) daily for 30 days .


A sixth group was fed a commercial diet containing lower amounts ( 0.12 % ) of phosphorus ( `` renal diet '' ) and no treatment .


When compared to the control group , Lenziaren produced significant dose-related reductions in urine phosphate concentrations , urine phosphate excretion and fractional urinary phosphate excretion .


Significant effects versus the control group were observed at the 0.5 , 1.0 and 2.0 g/day dosages .


Lenziaren was well tolerated and was associated with higher food consumption and serum iron concentrations versus the control .


When compared to the control group , the renal diet was associated with significantly lower urine phosphate concentrations and loss of body weight .


Lenziaren had similar effects on urine phosphate concentrations compared to the renal diet , but was not associated with loss of body weight .


Lenziaren was effective as an oral phosphate binder in cats fed with a standard diet containing 0.2 % phosphorus .


The acceptability and tolerability were good .


Dosages of 0.5-1 .0 g/cat per day are recommended for clinical testing in cats fed with a standard diet .


The present study evaluated three technology-based methods of training mental health providers in exposure therapy ( ET ) for anxiety disorders .


Training methods were designed to address common barriers to the dissemination of ET , including limited access to training , negative clinician attitudes toward ET , and lack of support during and following training .


Clinicians nave to ET ( N = 181 , Mage = 37.4 , 71.3 % female , 72.1 % Caucasian ) were randomly assigned to ( a ) an interactive , multimedia online training ( OLT ) , ( b ) OLT plus a brief , computerized motivational enhancement intervention ( OLT+ME ) , or ( c ) OLT+ME plus a Web-based learning community ( OLT+ME+LC ) .


Assessments were completed at baseline , posttraining , and 6 and 12weeks following training .


Outcomes include satisfaction , knowledge , self-efficacy , attitudes , self-reported clinical use , and observer-rated clinical proficiency .


All three training methods led to large and comparable improvements in self-efficacy and clinical use of ET , indicating that OLT alone was sufficient for improving these outcomes .


The addition of the ME intervention did not significantly improve outcomes in comparison to OLT alone .


Supplementing the OLT with both the ME intervention and the LC significantly improved attitudes and clinical proficiency in comparison to OLT alone .


The OLT+ME+LC condition was superior to both other conditions in increasing knowledge of ET .


Multicomponent trainings that address multiple potential barriers to dissemination appear to be most effective in improving clinician outcomes .


Technology-based training methods offer a satisfactory , effective , and scalable way to train mental health providers in evidence-based treatments such as ET .


We compared intestinal , hepatic , and other organ function after hepatic portal occlusion with or without dexmedetomidine administration under general anaesthesia .


In this prospective , randomized double-blind investigation , 44 patients undergoing elective hepatectomy with inflow occlusion were randomized into a dexmedetomidine group or a control group .


The dexmedetomidine group received an initial dexmedetomidine loading dose of 1 g kg ( -1 ) over 10 min followed by a maintenance dose of 0.3 g kg ( -1 ) h ( -1 ) .


In the control group , 0.9 % sodium chloride was administered .


The primary outcome was serum diamine oxidase ( DAO ) activity reflecting intestinal injury .


The secondary outcomes included variables reflecting intestinal , hepatic , kidney , and cardiopulmonary function , and biomarkers of oxidative stress and systemic inflammatory response .


DAO activity was lower in the dexmedetomidine group than in the control group at 6 and 24 h after liver reperfusion [ 9.77 ( 1.07 ) vs14 .29 ( 1.43 ) units ml ( -1 ) , P = 0.021 ; 9.67 ( 0.98 ) vs 13.97 ( 1.31 ) units ml ( -1 ) , P = 0.017 ] .


d-lactate acid levels were lower during 1-72 h after liver reperfusion compared with the control group ( all P < 0.05 ) .


Also , the intestinal injury severity grade was decreased by dexmedetomidine ( P = 0.038 ) .


The biomarkers reflecting liver injury increased over time , but were lower in the dexmedetomidine group ( all P < 0.05 ) , while the variables reflecting cardiopulmonary and renal function showed no differences between the groups ( all P > 0.05 ) .


Dexmedetomidine administered perioperatively attenuates intestinal and hepatic injury in patients undergoing elective liver resection with inflow occlusion without any potential risk .


ChiCTR-TRC-11001530 , September 2011 .


Nonsteroidal anti-inflammatory drugs are efficacious for the treatment of acute and chronic pain ; however , they have the potential for serious adverse events ( AEs ) .


The objective of this study was to evaluate the efficacy and safety of investigational , lower-dose , indomethacin submicron particle capsules compared with placebo in a study of patients with postsurgical pain .


This phase 2 , multicenter , randomized , double-blind , single-dose , and placebo-controlled study enrolled 203 patients ( 18 to 50 y old ) following extraction of 2 third molars who experienced moderate-to-severe pain intensity 6 hours after surgery .


Patients received indomethacin submicron particle capsules ( 20 or 40 mg ) , celecoxib 400 mg , or placebo .


The primary efficacy endpoint was the sum of total pain relief over 0 to 8 hours ( TOTPAR-8 ) determined from the area under the curve for pain relief over 0 to 8 hours following administration of the study drug , where pain relief was measured on a 0 to 4 scale .


Safety and tolerability were also assessed .


Mean SE TOTPAR-8 scores were 10.8 1.4 ( indomethacin submicron particle capsules 20 mg ) , 12.6 1.3 ( indomethacin submicron particle capsules 40 mg ) , 14.8 1.3 ( celecoxib ) , and 3.0 1.3 ( placebo ; P < 0.001 for active treatments vs. placebo ) .


Indomethacin submicron particle capsules treatment groups demonstrated better mean TOTPAR over 4 hours than placebo ( P < 0.001 ) .


Similar rates and profiles of treatment-emergent AEs were reported by patients across treatment groups .


Lower-dose , indomethacin submicron particle capsules provide good overall pain relief in patients with postsurgical pain and are generally well tolerated .


Indomethacin submicron particle capsules are a potentially promising option for treatment of acute pain and warrant further study .


National Surgical Adjuvant Breast and Bowel Project ( NSABP ) trial B-31 suggested the efficacy of adjuvant trastuzumab , even in HER2-negative breast cancer .


This finding prompted us to develop a predictive model for degree of benefit from trastuzumab using archived tumor blocks from B-31 .


Case subjects with tumor blocks were randomly divided into discovery ( n = 588 ) and confirmation cohorts ( n = 991 ) .


A predictive model was built from the discovery cohort through gene expression profiling of 462 genes with nCounter assay .


A predefined cut point for the predictive model was tested in the confirmation cohort .


Gene-by-treatment interaction was tested with Cox models , and correlations between variables were assessed with Spearman correlation .


Principal component analysis was performed on the final set of selected genes .


All statistical tests were two-sided .


Eight predictive genes associated with HER2 ( ERBB2 , c17orf37 , GRB7 ) or ER ( ESR1 , NAT1 , GATA3 , CA12 , IGF1R ) were selected for model building .


Three-dimensional subset treatment effect pattern plot using two principal components of these genes was used to identify a subset with no benefit from trastuzumab , characterized by intermediate-level ERBB2 and high-level ESR1 mRNA expression .


In the confirmation set , the predefined cut points for this model classified patients into three subsets with differential benefit from trastuzumab with hazard ratios of 1.58 ( 95 % confidence interval [ CI ] = 0.67 to 3.69 ; P = .29 ; n = 100 ) , 0.60 ( 95 % CI = 0.41 to 0.89 ; P = .01 ; n = 449 ) , and 0.28 ( 95 % CI = 0.20 to 0.41 ; P < .001 ; n = 442 ; P ( interaction ) between the model and trastuzumab < .001 ) .


We developed a gene expression-based predictive model for degree of benefit from trastuzumab and demonstrated that HER2-negative tumors belong to the moderate benefit group , thus providing justification for testing trastuzumab in HER2-negative patients ( NSABP B-47 ) .


To assess the neuropsychological outcome 12 months after bilateral deep brain stimulation ( DBS ) of the globus pallidus pars interna ( GPi ) or subthalamic nucleus ( STN ) for advanced Parkinson disease .


We randomly assigned patients to receive either GPi DBS or STN DBS .


Standardized neuropsychological tests were performed at baseline and after 12 months .


Patients and study assessors were masked to treatment allocation .


Univariate analysis of change scores indicated group differences on Stroop word reading and Stroop color naming ( confidence interval [ CI ] 1.9-10 .0 and 2.1-8 .8 ) , on Trail Making Test B ( CI 0.5-10 .3 ) , and on Wechsler Adult Intelligence Scale similarities ( CI -0.01 to 1.5 ) , with STN DBS showing greater negative change than GPi DBS .


No differences were found between GPi DBS and STN DBS on the other neuropsychological tests .


Older age and better semantic fluency at baseline predicted cognitive decline after DBS .


We found no clinically significant differences in neuropsychological outcome between GPi DBS and STN DBS .


No satisfactory explanation is available for the predictive value of baseline semantic fluency for cognitive decline .


This study provides Class I evidence that there is no large difference in neuropsychological outcome between GPi DBS and STN DBS after 12 months .


The study lacks the precision to exclude a moderate difference in outcomes .


There are relatively few studies in the literature that specifically evaluate accelerated rehabilitation protocols for distal radial fractures treated with open reduction and internal fixation ( ORIF ) .


The purpose of this study was to compare the early postoperative outcomes ( at zero to twelve weeks postoperatively ) of patients enrolled in an accelerated rehabilitation protocol with those of patients enrolled in a standard rehabilitation protocol following ORIF for a distal radial fracture .


We hypothesized that patients with accelerated rehabilitation after volar ORIF for a distal radial fracture would have an earlier return to function compared with patients who followed a standard protocol .


From November 2007 to November 2010 , eighty-one patients with an unstable distal radial fracture were prospectively randomized to follow either an accelerated or a standard rehabilitation protocol after undergoing ORIF with a volar plate for a distal radial fracture .


Both groups began with gentle active range of motion at three to five days postoperatively .


At two weeks , the accelerated group initiated wrist/forearm passive range of motion and strengthening exercises , whereas the standard group initiated passive range of motion and strengthening at six weeks postoperatively .


Patients were assessed at three to five days , two weeks , three weeks , four weeks , six weeks , eight weeks , twelve weeks , and six months postoperatively .


Outcomes included Disabilities of the Arm , Shoulder and Hand ( DASH ) scores ( primary outcome ) and measurements of wrist flexion/extension , supination , pronation , grip strength , and palmar pinch .


The patients in the accelerated group had better mobility , strength , and DASH scores at the early postoperative time points ( zero to eight weeks postoperatively ) compared with the patients in the standard rehabilitation group .


The difference between the groups was both clinically relevant and statistically significant .


Patients who follow an accelerated rehabilitation protocol that emphasizes motion immediately postoperatively and initiates strengthening at two weeks after volar ORIF of a distal radial fracture have an earlier return to function than patients who follow a more standard rehabilitation protocol .


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .


To compare the effects of administering equal volumes of isotonic crystalloids and synthetic colloids on hemodynamic and laboratory variables in healthy dogs and dogs with systemic inflammation .


Randomized , placebo-controlled , blinded study .


Comparative clinical research facility .


Sixteen adult purpose-bred Beagles .


Dogs were first randomized to receive either lipopolysaccharide ( LPS ; 5 g/kg , IV ) or an equal volume of placebo ( 0.9 % NaCl , IV ) .


Dogs were then randomized into 1 of 2 groups receiving fluid resuscitation with either 40 mL/kg IV isotonic crystalloid ( 0.9 % NaCl ) or synthetic colloid ( tetrastarch ) .


After a 14-day washout , the study was repeated such that dogs received the opposite treatment ( LPS or placebo ) and the same resuscitation fluid regimen .


Vital signs ( heart rate ( HR ) , oscillometric blood pressure ) were measured and blood samples were collected for PCV , total plasma protein ( TPP ) , serum lactate concentration , and colloid osmotic pressure ( COP ) measurements .


Healthy ( placebo ) dogs had similar decreases in PCV and TPP after administration of either fluid .


Tetrastarch administration was associated with a larger increase in HR , systolic blood pressure , and mean blood pressure .


Dogs with systemic inflammation had similar increases in systolic blood pressure and decreases in PCV , TPP , and lactate after administration of either fluid .


Tetrastarch administration caused greater immediate increase in HR and mean blood pressure compared to 0.9 % NaCl .


In all dogs , 0.9 % NaCl administration decreased COP and tetrastarch administration increased COP .


Resuscitation with equal volumes of 0.9 % NaCl and tetrastarch caused similar changes in hemodynamic and laboratory variables in dogs with LPS-induced systemic inflammation ; however , larger increases in HR and blood pressure were seen within the first 2 hours following tetrastarch administration compared to 0.9 % NaCl .


Tetrastarch administration increased COP in all dogs , despite a decrease in TPP .


Aortic valve replacement ( AVR ) in patients with a small aortic root is often associated with some degree of obstruction and residual gradients .


Stentless valves display better hemodynamic performance than stented valves , and might be ideal in patients with a small aortic annulus .


A new stented bioprosthesis , the Trifecta valve , has recently become available and has yielded interesting early results .


The study aim was to compare the hemodynamic performance of the Trifecta valve with that of the Freestyle valve in patients with an aortic annulus 2.3 cm .


Between September 2011 and September 2013 , a total of 40 patients with pure aortic stenosis and native aortic annulus diameter 2.3 cm was randomized to receive either a St. Jude Medical Trifecta stented prosthesis ( n = 20 ) or a Medtronic Freestyle stentless prosthesis ( n = 20 ) .


Hemodynamics results were compared between the two groups on discharge from hospital .


The Trifecta valve showed slightly better hemodynamics , with peak gradients of 11 5 mmHg and 17 9 mmHg ( p = 0.009 ) , and mean gradients of 5.5 3 mmHg and 7.5 4 mmHg ( p = 0.06 ) for the Trifecta and Freestyle valves , respectively .


The average indexed effective orifice area ( EOAi ) was 1.14 0.23 cm2/m2 and 1.09 0.20 cm2/m2 ( p = 0.520 ) for the Trifecta and Freestyle , respectively .


Patient-prosthesis mismatch ( PPM ) occurred in two patients of the Freestyle group , and in three patients of the Trifecta group .


In the present study , the stentless and stented prostheses each yielded comparable and excellent early hemodynamics results .


The data obtained suggest that Trifecta valve implantation is a valid means of avoiding PPM after AVR in patients with a small native aortic annulus .


To evaluate the efficacy and safety of once-daily oxybutynin patch therapy for overactive bladder .


A randomized double-blind trial was carried out in patients with overactive bladder syndrome , who received an oxybutynin patch , propiverine ( 20 mg ) or placebo once daily for 12 weeks .


The primary efficacy end-point was the change of the mean daily number of micturitions in week 12 .


A total of 1530 patients were randomized to receive the oxybutynin patch ( 573 ) , propiverine ( 576 ) or placebo ( 381 ) .


The change of the mean daily frequency of micturition from baseline in the full analysis set was -1.89 2.04 with the oxybutynin patch , which was significantly higher than with placebo ( -1.44 2.23 ) ( P = 0.0015 ) .


The difference of the mean change in the mean daily number of micturitions between the oxybutynin patch and propiverine groups showed a 95 % confidence interval of -0.28 to 0.21 , and the upper limit of this interval was below the predefined non-inferiority margin of 0.37 , showing non-inferiority of the oxybutynin patch to propiverine .


The incidence of dry mouth and constipation was higher with propiverine than with the oxybutynin patch or placebo .


Application site dermatitis was more frequent with the oxybutynin patch ( 31.8 % ) than with propiverine ( 5.9 % ) or placebo ( 5.2 % ) , but the dermatitis was generally mild .


This trial shows the efficacy of the new once-daily oxybutynin patch for overactive bladder .


Despite a higher rate of dermatitis with the oxybutynin patch , dry mouth and constipation occurs less often than during treatment with propiverine .


This study evaluated the effect of different types of activities during rest-break interventions on neck and shoulder muscle activity , muscle discomfort and productivity among symptomatic video display unit ( VDU ) operators performing prolonged computer terminal work .


Randomized controlled trial was used .


Thirty symptomatic VDU operators were randomly assigned to 2 active break groups ( stretching and dynamic movement ) and a reference group .


The subjects performed the same typing task for 60 min and received 3-min breaks after each 20 min of work .


Root mean square and median frequency were calculated for neck and shoulder muscle activity .


Muscle discomfort was measured with Borg 's CR-10 scale .


Productivity was measured by counting words .


There were no significant differences between the types of activities during breaks on neck and shoulder muscle activity , muscle discomfort or productivity .


However , there was a significant difference in the level of muscle discomfort over time .


Three types of activity during breaks showed a favourable effect on neck and shoulder muscle activity and productivity , and a positive effect on muscle discomfort in symptomatic VDU operators .


Physician-delivered tobacco treatment using the 5As is clinically recommended , yet its use has been limited .


Lack of adequate training and confidence to provide tobacco treatment is cited as leading reasons for limited 5A use .


Tobacco dependence treatment training while in medical school is recommended , but is minimally provided .


The MSQuit trial ( Medical Students helping patients Quit tobacco ) aims to determine if a multi-modal and theoretically-guided tobacco educational intervention will improve tobacco dependence treatment skills ( i.e. 5As ) among medical students .


10 U.S. medical schools were pair-matched and randomized in a group-randomized controlled trial to evaluate whether a multi-modal educational ( MME ) intervention compared to traditional education ( TE ) will improve observed tobacco treatment skills .


MME is primarily composed of TE approaches ( i.e. didactics ) plus a 1st year web-based course and preceptor-facilitated training during a 3rd year clerkship rotation .


The primary outcome measure is an objective score on an Objective Structured Clinical Examination ( OSCE ) tobacco-counseling smoking case among 3rd year medical students from schools who implemented the MME or TE .


MSQuit is the first randomized to evaluate whether a tobacco treatment educational intervention implemented during medical school will improve medical students ' tobacco treatment skills .


We hypothesize that the MME intervention will better prepare students in tobacco dependence treatment as measured by the OSCE .


If a comprehensive tobacco treatment educational learning approach is effective , while also feasible and acceptable to implement , then medical schools may substantially influence skill development and use of the 5As among future physicians .


PAD medical therapy has a number of limitations .


RLX showed promises in experimental model mainly through NO release .


Our study is the first to evaluate the efficacy and safety of RLX in PAD .


Eligible PAD La fontaine IIa-IIb patients were randomized in 2 groups .


Group A was treated with physical therapy plus oral pRLX , 20 ug b.i.d for 12 weeks , group B received physical therapy alone .


Pain Free Walking Distance ( PFWD ) and Maximum Walking Distance ( MWD ) at 3 and 12 wks and at follow up 3 months after treatment interruption were performed .


The percentage increases of PFWD in group B were 23 + / - 9 , 65 + / - 17 , and 35 + / - 4 respectively at 3 and at 12 weeks , and 3 months after termination .


In Group A showed significantly higher percentage increases : 74 + / - 16 p < 0.01 , 168 + / - 28 p < 0.001 , and 122 + / - 15 p < 0.001 at the corresponding time points .


The percentage increases of MWD in the B group were 29 + / - 7 , 55 + / - 10 and 54 + / - 8 at the above time points , while in the A group were 55 + / - 10 p < 0.001 , and 99 + / - 12 p < 0.001 .


The RLX patients referred a better physical and mental status .


No adverse events during or after the treatment were recorded .


RLX resulted very effective in PAD .


Our results may suggest that the observed functional benefits should come not only from hemodynamic improvement but also from positive vascular remodeling .


To determine whether baseline Heidelberg Retina Tomograph ( HRT ) measurements of the optic disc are associated with the development of open-angle glaucoma ( OAG ) in individuals with ocular hypertension in the European Glaucoma Prevention Study ( EGPS ) .


Retrospective analysis of a prospective , randomized , multicenter , double-masked , controlled clinical trial .


There were 489 participants in the HRT Ancillary Study to the EGPS .


Each baseline HRT parameter was assessed in univariate and multivariate proportional hazards models to determine its association with the development of OAG .


Proportional hazards models were used to identify HRT variables that predicted which participants in the EGPS had developed OAG .


Development of OAG was based on visual field and/or optic disc changes .


At a median follow-up time of about 5 years , 61 participants developed OAG .


In multivariate analyses , adjusting for randomization arm , age , baseline IOP , central corneal thickness , pattern standard deviation , and HRT disc area , the following HRT parameters were associated with the development of OAG : the `` outside normal limits '' classification of the Frederick Mikelberg ( FSM ) discriminant function ( hazard ratio [ HR ] 2.51 , 95 % confidence interval [ CI ] : 1.45-4 .35 ) , larger mean cup depth ( HR 1.64 , 95 % CI : 1.21-2 .23 ) , cup-to-disc area ratio ( HR 1.43 , 95 % CI : 1.14-1 .80 ) , linear cup-to-disc ratio ( HR 1.43 , 95 % CI : 1.13-1 .80 ) , cup area ( HR 1.33 , 95 % CI : 1.08-1 .64 ) , smaller rim area ( HR 1.33 , 95 % CI : 1.07-1 .64 ) , larger cup volume ( HR 1.30 , 95 % CI : 1.05-1 .61 ) , smaller rim volume ( HR 1.25 , 95 % CI : 1.01-1 .54 ) , larger maximum cup depth ( HR 1.18 , 95 % CI : 1.01-1 .36 ) , and cup shape measure ( HR 1.18 , 95 % CI : 1.01-1 .36 ) .


Several baseline HRT parameters , alone or in combination with baseline clinical and demographic factors , were significantly associated with the development of OAG among the EGPS participants .


The integrated diagnostics ( ID ) algorithm is an implantable device-based tool that collates data pertaining to heart rhythm , heart rate , intrathoracic fluid status , and activity , producing a risk score that correlates with 30-day risk of heart failure ( HF ) hospitalization .


We sought to validate the ID algorithm using the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial .


Diagnostic measures of the algorithm include OptiVol fluid index , nighttime heart rate , minutes of patient activity , heart rate variability , and combined measure of cardiac rhythm and biventricular pacing .


Monthly evaluations of ID parameters were assessed for the development of HF symptoms and hospitalization for HF .


A total of 1224 patients were included : 741 ( 61 % ) with cardiac resynchronization therapy with defibrillator devices and 483 ( 39 % ) with implanted cardioverter-defibrillator only .


The mean age was 66 9 years , and 1013 ( 83 % ) were men .


A total of 37,861 months of follow-up data were available , with 258 HF hospitalizations ( event rate 0.68 % per month ) .


There were 33 HF hospitalizations during low-risk months ( 0.21 % per month ) , 123 during medium-risk months ( 0.66 % per month ) , and 102 during high-risk months ( 2.61 % per month ) .


Compared with low-risk months , and 95 % confidence intervals ) of HF hospitalizations during medium-risk months was 2.9 ( 2.0-4 .4 ) and during high-risk months was 10.7 ( 6.9-16 .6 ) .


Multivariable analysis demonstrated that each ID variable had independent association with HF hospitalization .


The risk of HF as determined by the ID algorithm correlated with HF hospitalization and several HF signs and symptoms among patients in the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial .


This may present a useful adjunct to detect early signs of HF and adjust therapy to reduce morbidity and costs involved with hospital admission .


To compare effects of combinations of standard and intensive treatment of glycemia and either blood pressure ( BP ) or lipids in the Action to Control Cardiovascular Risk in Diabetes ( ACCORD ) trial .


ACCORD enrolled 10,251 type 2 diabetes patients aged 40-79 years at high risk for cardiovascular disease ( CVD ) events .


Participants were randomly assigned to hemoglobin A1c goals of < 6.0 % ( < 42 mmol/mol ; intensive glycemia ) or 7.0-7 .9 % ( 53-63 mmol/mol ; standard glycemia ) and then randomized a second time to either 1 ) systolic BP goals of < 120 mmHg ( intensive BP ) or < 140 mmHg ( standard BP ) or 2 ) simvastatin plus fenofibrate ( intensive lipid ) or simvastatin plus placebo ( standard lipid ) .


Proportional hazards models were used to assess combinations of treatment assignments on the composite primary ( deaths due to CVD , nonfatal myocardial infarction [ MI ] , and nonfatal stroke ) and secondary outcomes .


In the BP trial , risk of the primary outcome was lower in the groups intensively treated for glycemia ( hazard ratio [ HR ] 0.67 ; 95 % CI 0.50-0 .91 ) , BP ( HR 0.74 ; 95 % CI 0.55-1 .00 ) , or both ( HR 0.71 ; 95 % CI 0.52-0 .96 ) compared with combined standard BP and glycemia treatment .


For secondary outcomes , MI was significantly reduced by intensive glycemia treatment and stroke by intensive BP treatment ; most other HRs were neutral or favored intensive treatment groups .


In the lipid trial , the general pattern of results showed no evidence of benefit of intensive regimens ( whether single or combined ) compared with combined standard lipid and glycemia treatment .


The mortality HR was 1.33 ( 95 % CI 1.02-1 .74 ) in the standard lipid/intensive glycemia group compared with the standard lipid/standard glycemia group .


In the ACCORD BP trial , compared with combined standard treatment , intensive BP or intensive glycemia treatment alone improved major CVD outcomes , without additional benefit from combining the two .


In the ACCORD lipid trial , neither intensive lipid nor glycemia treatment produced an overall benefit , but intensive glycemia treatment increased mortality .


Nitric oxide ( NO ) is essential for the optimal perfusion of the heart and its vasculature .


NO may be insufficient in surgical patients because its precursor arginine is decreased , and the inhibitor of NO synthesis asymmetric dimethylarginine ( ADMA ) is increased .


Besides arginine , the presence of other amino acids essential for the proper metabolism of cardiac cells may be decreased too .


Supplementation of these amino acids with enteral and parenteral nutrition before , during , and after surgery may augment the myocardial and plasma arginine : ADMA ratio and availability of amino acids .


Myocardial glucose metabolism and nutritional conditioning may result in a reduction of cardiac injury and support rapid recovery after major surgery .


We investigated the effect of nutrition before , during , and after surgery on amino acids and the myocardial arginine : ADMA ratio and its relation to myocardial glucose metabolism .


In this trial , 33 patients who were undergoing off-pump coronary artery bypass grafting ( CABG ) were randomly assigned between enteral , parenteral , or no nutrition ( control ) from 2 d before , during , and until 2 d after surgery .


Both enteral and parenteral solutions were prepared with commercially available products and included proteins or amino acids , glucose , vitamins , and minerals .


Concentrations of amino acids including ADMA were analyzed in myocardial tissue and plasma samples .


F-fluorodeoxyglucose positron emission tomography was performed before and after surgery to assess myocardial glucose metabolism .


The myocardial arginine : ADMA ratio increased during surgery and was significantly higher in the enteral and parenteral groups than in the control group [ median ( IQR ) : 115.0 ( 98.0-142 .2 ) ( P = 0.012 ) , 116.9 ( 100.3-135 .3 ) ( P = 0.004 ) , and 93.3 ( 82.7-101 .1 ) , respectively ] .


Furthermore , the change in the preoperative to postoperative plasma arginine : ADMA ratio correlated with the change in myocardial glucose metabolism in positron emission tomography ( r = 0.427 , P = 0.033 ) .


Enteral or parenteral nutrition before , during , and after CABG may positively influence myocardial glucose metabolism by increasing the plasma and myocardial arginine : ADMA ratio .


Benefits of art participation after stroke are becoming increasingly recognized .


Qualitative studies suggest that participation in visual arts creative engagement interventions ( CEIs ) during rehabilitation after stroke may improve mood , self-esteem , hope and some aspects of physical recovery .


This study examines the feasibility of undertaking a randomized controlled trial of a CEI delivered by artists within in-patient stroke rehabilitation to test effectiveness .


This trial is a two arm , single-blind , randomized controlled feasibility trial within in-patient stroke rehabilitation .


We will recruit 80 patients receiving stroke rehabilitation in two stroke units in a health board area of Scotland ( 40 patients in each arm ) .


Intervention arm participants will receive a visual-arts based CEI facilitated by experienced artists .


Artists will follow an intervention protocol with specific components that enable participants to set , achieve and review artistic goals .


Participants will receive up to eight intervention sessions , four within a group and four one-to-one with the artist .


Control group participants will receive usual care only.Data collection will occur at baseline , post-intervention and three-month follow-up .


Stroke-related health status is the primary outcome ; mood , self-esteem , self-efficacy , perceived recovery control and hope are secondary outcomes .


Semi-structured interviews will be conducted with purposively selected patients , artists and healthcare staff to elicit views and experiences of the intervention and feasibility and acceptability of trial processes .


Recruitment rates , retention rates and patient preference for art participation will also be collected .


Data will indicate , with confidence intervals , the proportion of patients choosing or refusing participation in the CEI and will allow calculation of recruitment rates for a future definitive trial .


Summary data will indicate potential variability , magnitude and direction of difference between groups .


Findings will inform sample size calculations for a definitive trial .


Thematic analysis of qualitative data will be managed using the Framework Approach .


Framework is an analytical approach for qualitative data , commonly used in policy and medical research .


If shown to demonstrate effects , this intervention has the potential to address aspects of stroke recovery previously .


Not routinely addressed in rehabilitation .


Registered with Clinical Trials.Gov : NCT02085226 on 6th March 2014 .


The aim of this study was to evaluate the impact of two different therapeutic strategies in patients with partial seizures who were intractable to the first prescribed antiepileptic drug ( AED ) ; alternative monotherapy vs early add-on treatment .


We conducted an open , cluster-randomised , prospective , controlled trial in patients with persistent partial seizures , despite treatment with one AED , who were never administered any other AEDs .


Neurologists were randomised to two strategies : in group A , an alternative monotherapy with a second AED was employed ; in group B , add-on treatment with a second AED was employed .


The primary outcome was the percentage of seizure-free patients during a two-month period after six months of treatment .


The secondary outcomes were : ( i ) the percentage of patients achieving a 50 % reduction in the number of seizures at six months ; ( ii ) the quality of life based on the Quality Of Life In Epilepsy scale ; and ( iii ) tolerability .


A total of 143 neurologists were included and randomised , and 264 patients were evaluated .


At six months , the primary outcome was 51 % in group A and 45 % in group B ( p = 0.34 ) .


The percentage of patients achieving a 50 % reduction in the number of seizures at six months was 76 % in group A and 84 % in group B ( p = 0.53 ) .


The quality of life and the tolerability did not significantly differ between the two groups .


Alternative monotherapy or early treatment initiation with another AED drug resulted in similar efficacy , and the side effects associated with monotherapy and combined therapies were similar , which suggests that individual susceptibility is more important than the number and burden of AEDs used .


This study was designed to evaluate the effects of perioperative administration of an isotonic electrolyte solution with 1 % glucose ( IT ) on blood sodium ( Na + ) and blood glucose ( BG ) concentrations in pediatric patients < 1-year-old undergoing plastic surgery in comparison with a conventional hypotonic electrolyte solution with 2.6 % glucose ( HT ) .


Fifty Patients were randomly allocated to HT group and IT group .


Na + and BG were measured at induction of anesthesia ( Tind ) , the end of surgery ( Tend ) , and 4 hours after surgery ( T4h ) .


Patient characteristics were similar for the 2 groups .


In the HT group , Na + at Tend insignificantly dropped compared with that at Tind , whereas in the IT group Na + was significantly elevated .


Na + at T4h significantly increased compared with that at Tend in each group .


No cases developed new dysnatremia or dysglycemia in IT group .


The incidence of hyponatremia at Tend was significantly lower in the IT group .


A positive correlation between intraoperative Na + concentration changes and the infusion duration was observed in the IT group .


Isotonic solution with 1 % glucose is suggested to be safe in infants during and after surgery .


Evaluate changes in active and passive function with onabotulinumtoxinA + standard of care within goal-oriented rehabilitation programmes in adults with focal post-stroke spasticity .


Prospective , 24-week double-blind study with an open-label extension .


Subjects were randomized to onabotulinumtoxinA + standard of care or placebo + standard of care , at baseline and at 12 weeks , if judged appropriate , with follow-up to 52 weeks .


The primary endpoint was the number of patients achieving their principal active functional goal at 24 weeks ( or 10 weeks after an optional second injection ) .


Secondary endpoints included achievement of a different active or a passive goal at this timepoint .


The intent-to-treat population comprised 273 patients .


The proportion of patients achieving their principal active functional goal and secondary active functional goal with onabotulinumtoxinA + standard of care was not statistically different from placebo + standard of care .


Significantly more patients achieved their secondary passive goal with onabotulinumtoxinA + standard of care ( 60.0 % ) vs. placebo + standard of care ( 38.6 % ) ( odds ratio , 2.46 ; 95 % confidence interval , 1.18-5 .14 ) as well as higher Goal Attainment Scaling levels for upper limb and ankle flexor subgroups .


Addition of onabotulinumtoxinA to standard of care as part of goal-oriented rehabilitation in post-stroke spasticity patients significantly increased passive goal achievement and was associated with higher levels of active function .


Despite targeted antiemetics , data support an unmet need related to the management of delayed nausea and vomiting ( NV ) .


Promising pilot data informed this phase III trial evaluating gabapentin for delayed NV from highly emetogenic chemotherapy ( HEC ) .


Participants were randomized to receive prophylactic treatment with 20 mg of dexamethasone and a 5HT3 receptor antagonist ( RA ) on the day of chemotherapy , followed by gabapentin 300 mg twice a day and dexamethasone ( dex ) or placebo and dex after HEC .


Gabapentin/placebo was started the day of chemotherapy and continued through day 5 for the first chemotherapy cycle , whereas dex was titrated down on days 2-4 .


The primary end point was complete response ( CR ) , defined as no emesis and no use of rescue medications on days 2-6 , using an NV diary .


The percentages of those in each group with a CR were compared by Fisher 's exact test .


Four hundred thirty patients were enrolled in this study .


Forty-seven percent of patients in the gabapentin arm and 41 % in the placebo arm had a CR ( P = .23 ) .


Mean number of emesis episodes was < 0.5 daily , and mean nausea severity was < 2 ( mild ) .


In both arms , patient satisfaction with NV control was greater than 8 ( with 10 being perfectly satisfied ) .


There were no significant differences in unwanted side effects .


In this study , gabapentin did not significantly improve delayed NV .


Patients were satisfied with the control of their nausea and vomiting irrespective of arm .


The use of a 5HT3 RA and dexamethasone provided good control of nausea and vomiting for most patients .


Previous studies suggested intravenous or nebulised magnesium sulphate ( MgSO ( 4 ) ) might improve respiratory function in patients with acute asthma .


We aimed to determine whether intravenous or nebulised MgSO ( 4 ) improve symptoms of breathlessness and reduce the need for hospital admission in adults with severe acute asthma .


In our double-blind , placebo-controlled trial , we enrolled adults ( aged 16 years ) with severe acute asthma at emergency departments of 34 hospitals in the UK .


We excluded patients with life-threatening features or contraindication to study drugs .


We used a central randomisation system to allocate participants to intravenous MgSO ( 4 ) ( 2 g in 20 min ) or nebulised MgSO ( 4 ) ( three 500 mg doses in 1 h ) alongside standard therapy including salbutamol , or placebo control plus standard therapy alone .


We assessed two primary outcome measures in all eligible participants who started treatment , according to assigned treatment group : the proportion of patients admitted to hospital within 7 days and breathlessness measured on a 100 mm visual analogue scale ( VAS ) in the 2 h after initiation of treatment .


We adjusted for multiple testing using Simes 's method .


The trial stopped before recruitment was completed because funding expired .


This study is registered , number ISRCTN04417063 .


Between July 30 , 2008 , and June 30 , 2012 , we recruited 1109 ( 92 % ) of 1200 patients proposed by the power calculation .


261 ( 79 % ) of 332 patients allocated nebulised MgSO ( 4 ) were admitted to hospital before 7 days , as were 285 ( 72 % ) of 394 patients allocated intravenous MgSO ( 4 ) and 281 ( 78 % ) of 358 controls .


Breathlessness was assessed in 296 ( 89 % ) patients allocated nebulised MgSO ( 4 ) , 357 ( 91 % ) patients allocated intravenous MgSO ( 4 ) , and 323 ( 90 % ) controls .


Rates of hospital admission did not differ between patients treated with either form of MgSO ( 4 ) compared with controls or between those treated with nebulised MgSO ( 4 ) and intravenous MgSO ( 4 ) .


Change in VAS breathlessness did not differ between active treatments and control , but change in VAS was greater for patients in the intravenous MgSO ( 4 ) group than it was in the nebulised MgSO ( 4 ) group ( 51 mm , 08 to 94 ; p = 0019 ) .


Intravenous or nebulised MgSO ( 4 ) did not significantly decrease rates of hospital admission and breathlessness compared with placebo : intravenous MgSO ( 4 ) was associated with an odds ratio of 073 ( 95 % CI 051 to 104 ; p = 0083 ) for hospital admission and a change in VAS breathlessness of 26 mm ( -16 to 68 ; p = 0231 ) compared with placebo ; nebulised MgSO ( 4 ) was associated with an odds ratio of 096 ( 065 to 140 ; p = 0819 ) for hospital admission and a change in VAS breathlessness of -26 mm ( -70 to 18 ; p = 0253 ) compared with placebo .


Our findings suggest nebulised MgSO ( 4 ) has no role in the management of severe acute asthma in adults and at best suggest only a limited role for intravenous MgSO ( 4 ) in this setting .


UK National Institute for Health Research Health Technology Assessment Programme .


To test the effect of 8 weeks of lower body resistance training on hyperglycemia and dyslipidemia , which may be prevalent among nonelderly , nondiabetic , chronically disabled stroke patients .


Randomized controlled study .


Outpatient clinics of rehabilitation centers .


Nonelderly , nondiabetic , chronically disabled stroke subjects ( N = 56 ) were enrolled and randomly assigned to an experimental group ( n = 28 ) and a control group ( n = 28 ) .


Lower body resistance training was performed by subjects in the experimental group 3 times a week for 8 weeks .


The control group was given duration-matched stretch exercises .


Fasting glucose level , fasting insulin level , 2-hour blood glucose level during oral glucose tolerance test , homeostasis model assessment of insulin resistance ( HOMA-IR ) , glycosylated hemoglobin ( Hb A1c ) , total triglyceride level , total cholesterol level , high-density lipoprotein ( HDL ) cholesterol level , low-density lipoprotein ( LDL ) cholesterol level , body mass index , lower limb muscle strength , and Fugl-Meyer motor score .


Before the intervention , 34 subjects ( 60.7 % ) had hyperglycemia and 38 ( 67.9 % ) had dyslipidemia .


Fifty-one subjects finished the study .


Subjects in the experimental group ( n = 26 ) showed significant improvements in fasting insulin and 2-hour blood glucose levels ; HOMA-IR ; total cholesterol , HDL cholesterol , and LDL cholesterol levels ; and muscle strength compared with control subjects ( n = 25 ) after the intervention ( P < .05 ) .


Resistance training may play a significant role in improving hyperglycemia and dyslipidemia , which are frequently present among nonelderly , nondiabetic , chronically disabled stroke patients .


There is little evidence for the optimal form of nonoperative treatment in the management of frozen shoulder .


This study assesses the efficacy of current physiotherapy strategies .


All primary care referrals of frozen shoulder to our physiotherapy department were included during a 12-month period .


Of these referrals , 17 % met the inclusion criteria for primary idiopathic frozen shoulder .


The 75 patients were randomly assigned to 1 of 3 groups : group exercise class , individual physiotherapy , and home exercises alone .


A single independent physiotherapist , who was blinded to the treatment groups , made all assessments .


Range of motion , Constant score , Oxford Shoulder Score , Short Form 36 , and Hospital Anxiety and Disability Scale ( HADS ) outcome measures were performed at baseline , 6 weeks , 6 months , and 1 year .


The exercise class group improved from a mean Constant score of 39.8 at baseline to 71.4 at 6 weeks and 88.1 at 1 year .


There was a significant improvement in shoulder symptoms on Oxford and Constant scores ( P < .001 ) .


This improvement was greater than with individual physiotherapy or home exercises alone ( P < .001 ) .


The improvement in range of motion was significantly greater in both physiotherapy groups over home exercises ( P < .001 ) .


HADS scores significantly improved during the course of treatment ( P < .001 ) .


The improvement in HADS anxiety score was significantly greater in both physiotherapy intervention groups than in home exercises alone .


A hospital-based exercise class can produce a rapid recovery from a frozen shoulder with a minimum number of visits to the hospital and is more effective than individual physiotherapy or a home exercise program .


Primary aim of this study was to evaluate if patient morbidity was improved by diminishing graft thickness and height ; secondary objective was to evaluate if such graft modifications influence root coverage and aesthetic outcomes .


60 Miller class I and II gingival recessions ( GR ) ( 3 mm in depth ) were treated with the coronally advanced flap plus extraoral de-epithelialized free gingival graft ( FGG ) .


In 30 randomly selected control GRs ( `` big graft group '' ) , the FGG thickness was 2 mm and the height was equal to bone dehiscence ( BD ) ; in the other 30 test defects ( `` small graft group '' ) , the thickness of the FGG was < 2 mm and the height was 4 mm .


The post-operative patient morbidity was assessed 1 week after the surgery .


The clinical and aesthetic evaluations were performed 1 year after the surgery .


Lower analgesic assumption , better post-operative course evaluations , better patient colour match scores and better periodontist aesthetic assessments were reported in the `` small graft '' group .


No statistically significant differences were demonstrated between the two groups in terms of recession reduction , CRC and increase in KTH .


Greater GT increase was obtained in the control-treated sites .


Coronally advanced flap plus CTG of reduced thickness and height was associated with less patient morbidity , better aesthetic evaluations with no difference in RC outcomes .


The purpose of this study was to assess the effect of 8-weeks ingestion of a commercialized joint pain dietary supplement ( Instaflex Joint Support , Direct Digital , Charlotte , NC ) compared to placebo on joint pain , stiffness , and function in adults with self-reported joint pain .


Instaflex is a joint pain supplement containing glucosamine sulfate , methylsufonlylmethane ( MSM ) , white willow bark extract ( 15 % salicin ) , ginger root concentrate , boswella serrata extract ( 65 % boswellic acid ) , turmeric root extract , cayenne , and hyaluronic acid .


Subjects included 100 men and women , ages 50-75 years , with a history ( > 3 months ) of joint pain , and were randomized to Instaflex or placebo ( 3 colored gel capsules per day for 8 weeks , double-blind administration ) .


Subjects agreed to avoid the use of non-steroidal anti-inflammatory drugs ( NSAID ) and all other medications and supplements targeted for joint pain .


Primary outcome measures were obtained pre - and post-study and included joint pain severity , stiffness , and function ( Western Ontario and McMaster Universities [ WOMAC ] ) , and secondary outcome measures included health-related quality of life ( Short Form 36 or SF-36 ) , systemic inflammation ( serum C-reactive protein and 9 plasma cytokines ) , and physical function ( 6-minute walk test ) .


Joint pain symptom severity was assessed bi-weekly using a 12-point Likert visual scale ( 12-VS ) .


Joint pain severity was significantly reduced in Instaflex compared to placebo ( 8-week WOMAC , 37 % versus 16 % , respectively , interaction effect P = 0.025 ) , with group differences using the 12-VS emerging by week 4 of the study ( interaction effect , P = 0.0125 ) .


Improvements in ability to perform daily activities and stiffness scores in Instaflex compared to placebo were most evident for the 74 % of subjects reporting knee pain ( 8-week WOMAC function score , 39 % versus 14 % , respectively , interaction effect P = 0.027 ; stiffness score , 30 % versus 12 % , respectively , interaction effect P = 0.081 ) .


Patterns of change in SF-36 , systemic inflammation biomarkers , and the 6-minute walk test did not differ significantly between groups during the 8-week study


Results from this randomized , double blind , placebo-controlled community trial support the use of the Instaflex dietary supplement in alleviating joint pain severity in middle-aged and older adults , with mitigation of difficulty performing daily activities most apparent in subjects with knee pain .


The aim of this study was to investigate the effects of two different treatment regimes in patients with IgA nephropathy ( IgAN ) : steroids alone and in combination with a medium dose of cyclosporine A ( CsA ) .


Forty-eight IgAN patients 18-69 years of age with proteinuria > 1.0 g/24 hours and an estimated glomerular filtration rate ( eGFR ) of > 30 mL/min/1 .73 m ( 2 ) were randomly given either steroids alone ( methylprednisolone ( MP ) group ; n = 25 ) or steroids plus CsA treatment ( combination group ; n = 23 ) .


The primary endpoint was the reduction of proteinuria by 50 % or more of the baseline value .


The secondary endpoint was an increase in the baseline serum creatinine level of 50 % or a decrease in the baseline eGFR of 25 % .


After 12 months of treatment , all patients in the combination group and 87.50 % of the patients in the MP group reached the primary endpoint .


The complete remission rates in the combination group and MP group were 50.0 % and 45.83 % , respectively .


The level of urinary protein excretion declined from 3.17 3.25 g/24 hours to 0.36 0.23 g/24 hours ( p < 0.001 ) in the combination group and from 2.60 2.03 g/24 hours to 0.53 0.71 g/24 hours ( p < 0.001 ) in the MP group .


Two patients in the combination group reached the secondary endpoint , with a decrease in the eGFR of 25 % from the baseline value , while no patients in the MP group achieved this goal .


The patients in the combination group exhibited significant improvements in the eGFR after nine months ( 90.16 28.78 vs. 80.46 22.73 mL/min .1.73 m ( 2 ) , p = 0.011 ) , while the patients in the MP group showed significant increases in the eGFR after six months of treatment ( 92.18 22.71 to 81.63 18.36 mL/min/1 .73 m ( 2 ) , p = 0.019 ) .


Four patients ( 8.33 % ) developed severe pneumonia during treatment .


Both the full dose of steroids alone and combined treatment with steroids and a medium dose of CsA remarkably reduced the levels of proteinuria and ameliorated the renal function in the IgAN patients .


Infection was the most serious complication during the treatment .


To assess the effect of aging on stretch reflex modulation during walking , soleus H-reflexes obtained in 15 middle-aged ( mean age 56.46.9 years ) and 15 young ( mean age 23.73.9 years ) subjects were compared .


The H-reflex amplitude , muscle activity ( EMG ) of the soleus and tibialis anterior muscles , and EMG/H-reflex gain were measured during 4-km/h treadmill walking .


The normalized H-reflex amplitude was lower in the swing phase for the middle-aged group , and there was no difference in muscle activity .


EMG/H-reflex gain did not differ between groups .


H-reflex amplitude during walking was affected by aging , and changes during the swing phase could be seen in the middle-aged subjects .


Subdividing the 2 age groups into groups of facilitated or suppressed swing-phase H-reflex revealed that the H-reflex amplitude modulation pattern in the group with facilitated swing-phase H-reflex may be influenced by aging .


The aim of this randomized , prospective and double blinded study is to investigate effects of different esmolol use on hemodynamic response of laryngoscopy , endotracheal intubation and sternotomy in coronary artery bypass graft surgery .


After approval of local ethics committee and patients ' written informed consent , 45 patients were randomized into three groups equally .


In Infusion Group ; from 10 min before intubation up to 5th minute after sternotomy , 0.5 mg/kg/min esmolol infusion , in Bolus Group ; 2 min before intubation and sternotomy 1.5 mg/kg esmolol IV bolus and in Control Group ; % 0.9 NaCl was administered .


All demographic parameters were recorded .


Heart rate and blood pressure were recorded before infusion up to anesthesia induction in every minute , during endotracheal intubation , every minute for 10 minutes after endotracheal intubation and before , during and after sternotomy at first and fifth minutes .


While area under curve ( AUC ) ( SAPtime ) was being found more in Group B and C than Group I , AUC ( SAPTint and Tst ) and AUC ( SAPT2 ) was found more in Group B and C than Group I ( p < 0.05 ) .


Moreover AUC ( HRTst ) was found less in Group B than Group C but no significant difference was found between Group B and Group I.


This study highlights that esmolol infusion is more effective than esmolol bolus administration on controlling systolic arterial pressure during endotracheal intubation and sternotomy in CABG surgery .


The aim of this study was to determine whether intermittent ambulatory treatment with levosimendan would improve functional capacity , quality of life , and event-free survival in patients with advanced heart failure .


This was a prospective , randomized , double-blind , placebo-controlled , multicentre , parallel-group trial of pulsed infusions of levosimendan in 120 outpatients with advanced heart failure ( EF 35 % , NYHA class III or IV ) .


The study was conducted at 11 centres in Austria , Greece , and Germany .


Levosimendan ( 0.2 g/kg/min ) or placebo was administered for 6 h at 2-week intervals over 6 weeks , in addition to standard care therapy .


The primary outcome was the proportion of patients with a 20 % improvement in the 6 min walk test and a 15 % score increase on the Kansas City Cardiomyopathy Questionnaire at the end of the 24-week study period .


Secondary outcomes included event-free survival after 24 weeks .


Analyses were performed on an intention-to-treat basis .


The primary endpoint was reached in 19 % of patients receiving levosimendan and 15.8 % of patients receiving placebo ( odds ratio 1.25 ; 95 % confidence interval 0.44-3 .59 ; P = 0.810 ) .


Cardiac death ( four vs. one ) , heart transplants ( two vs. one ) , and acute heart failure ( 14 vs. nine ) were more frequent with placebo as compared with levosimendan .


The incidence of side effects was comparable between groups .


Intermittent ambulatory treatment with levosimendan in patients with advanced heart failure did not improve significantly functional capacity or quality of life as compared with placebo .


An adequately powered , event-driven trial is warranted to enlarge on our findings .


NCT01065194 .


This mixed methods study explored the characteristics of and experiences with perceived discrimination in an ethnically diverse urban sample of adults experiencing homelessness and mental illness .


Data were collected in Toronto , Ontario , as part of a 4-year national randomized field trial of the Housing First treatment model .


Rates of perceived discrimination were captured from survey questions regarding perceived discrimination among 231 ethnoracially diverse participants with moderate mental health needs .


The qualitative component included thirty six in-depth interviews which explored how individuals who bear these multiple identities of oppression navigate stigma and discrimination , and what affects their capacity to do so .


Quantitative analysis revealed very high rates of perceived discrimination related to : homelessness/poverty ( 61.5 % ) , race/ethnicity/skin colour ( 50.6 % ) and mental illness/substance use ( 43.7 % ) .


Immigrants and those who had been homeless three or more years reported higher perceived discrimination on all three domains .


Analysis of qualitative interviews revealed three common themes related to navigating these experiences of discrimination among participants : 1 ) social distancing ; 2 ) old and new labels/identities ; and , 3 ) ` homeland ' cultures .


These study findings underscore poverty and homelessness as major sources of perceived discrimination , and expose underlying complexities in the navigation of multiple identities in responding to stigma and discrimination .


Current Controlled Trials ISRCTN42520374 .


Registered 18 August 2009 .


To evaluate the impact of complement factor H ( CFH ) and age-related maculopathy susceptibility 2 ( ARMS2 ) risk alleles on the observed response to components of the Age-Related Eye Disease Study ( AREDS ) formulation .


Genetic and statistical subgroup analysis of a randomized , prospective clinical trial .


White patients from the AREDS with category 3 or 4 age-related macular degeneration ( AMD ) with available DNA ( n = 989 ) .


Four genotype groups based on CFH and ARMS2 risk allele number were defined .


Progression to advanced AMD was analyzed by genotype and treatment using Cox proportionate hazards estimates and 7-year events .


The effect of predefined genotype group on treatment-specific progression to advanced AMD .


Patients with 2 CFH risk alleles and no ARMS2 risk alleles progressed more with zinc-containing treatment compared with placebo , with a hazard ratio ( HR ) of 3.07 ( P = 0.0196 ) for zinc and 2.73 ( P = 0.0418 ) for AREDS formulation ( AF ) .


Seven-year treatment-specific progression rates were : placebo , 17.0 % ; zinc , 43.2 % ( P = 0.023 ) ; and AF , 40.2 % ( P = 0.039 ) .


Patients with 0 or 1 CFH risk alleles and 1 or 2 ARMS2 risk alleles benefited from zinc-containing treatment compared with placebo , with an HR of 0.514 for zinc ( P = 0.012 ) and 0.569 for AF ( P = 0.0254 ) .


Seven-year treatment-specific AMD progression rates were as follows : placebo , 43.3 % ; zinc , 25.2 % ( P = 0.020 ) ; and AF , 27.3 % ( P = 0.011 ) .


Zinc and AF treatment each interacted statistically with these 2 genotype groups under a Cox model , with P values of 0.000999 and 0.00366 , respectively .


For patients with 0 or 1 CFH risk alleles and no ARMS2 risk alleles , neither zinc-containing treatment altered progression compared with placebo , but treatment with antioxidants decreased progression ( HR , 0.380 ; P = 0.034 ) .


Seven-year progression with placebo was 22.6 % and with antioxidants was 9.17 % ( P = 0.033 ) .


For patients with 2 CFH risk alleles and 1 or 2 ARMS2 risk alleles , no treatment was better than placebo ( 48.4 % ) .


The benefit of the AREDS formulation seems the result of a favorable response by patients in only 1 genotype group , balanced by neutral or unfavorable responses in 3 genotype groups .


To evaluate the effect of ocular draping on rates of bacterial contamination of the ocular surface immediately after intravitreal injection using a plate-type eyelid speculum .


Twelve institutions participated in this prospective randomized study .


Patients from each institution undergoing intravitreal injections were randomly assigned to 2 groups , with and without ocular draping .


Following each institution 's standard protocol for aseptic preparation , intravitreal injection was performed using a plate-type eyelid speculum designed for intravitreal injections with or without draping .


Immediately after the intravitreal injection , a cotton swab was used to obtain a sample at the injection site and sent for bacterial culture .


Of 262 eyes involved in the study , cultures were positive in five eyes ( 1.9 % ) using standard methods and positive in an additional 25 eyes ( 9.5 % ) using methods to increase culture sensitivity .


There was no significant difference in the combined rate of bacterial contamination between the 2 groups ( p = 0.561 , Fisher 's exact test ) .


Ocular draping did not decrease the rate of bacterial contamination immediately after intravitreal injection performed using a plate-type eyelid speculum .


To examine the effect of donor age and other perioperative factors on long-term endothelial cell loss after penetrating keratoplasty ( PKP ) .


Multicenter , prospective , double-masked clinical trial .


We included 176 participants from the Cornea Donor Study cohort who had not experienced graft failure 10 years after PKP for a moderate risk condition ( principally Fuchs ' dystrophy or pseudophakic/aphakic corneal edema ) .


Corneas from donors 12 to 75 years old were assigned to participants using a randomized approach , without respect to recipient factors .


Surgery and postoperative care were performed according to the surgeons ' usual routines .


Images of the central endothelium were obtained preoperatively and at intervals for 10 years postoperatively .


Images were analyzed by a central image analysis reading center to determine endothelial cell density ( ECD ) .


Endothelial cell density at 10 years .


Among study participants with a clear graft at 10 years , the 125 who received a cornea from a donor 12 to 65 years old experienced a median cell loss of 76 % , resulting in a 10-year median ECD of 628 cells/mm ( 2 ) ( interquartile range [ IQR ] , 522-850 cells/mm ( 2 ) ) , whereas the 51 who received a cornea from a donor 66 to 75 years old experienced a cell loss of 79 % , resulting in a median 10-year ECD of 550 cells/mm ( 2 ) ( IQR , 483-694 cells/mm ( 2 ) ; P adjusted for baseline ECD = 0.03 ) .


In addition to younger donor age , higher ECD values were significantly associated with higher baseline ECD ( P < 0.001 ) and larger donor tissue size ( P < 0.001 ) .


Forty-two of the 176 participants ( 24 % ) had an ECD of < 500 cells/mm ( 2 ) at 10 years and only 24 ( 14 % ) had an ECD of > 1000 cells/mm ( 2 ) .


Substantial cell loss occurs in eyes with a clear graft 10 years after PKP , with the rate of cell loss being slightly greater with older donor age .


Greater preoperative ECD and larger donor tissue size are associated with higher ECD at 10 years .


Nesfatin-1 is an anorexigenic hormone suggested to regulate obesity .


To investigate the relationship between nesfatin-1 level and anthropometric and metabolic parameters in obese patients , and examine the change in plasma nesfatin-1 level after acupuncture treatment .


64 obese adult patients without diabetes and 58 normal weight control subjects were enrolled in this study .


The obese patients were randomly divided into an acupuncture plus diet group ( n = 32 ) and a diet only group ( n = 32 ) .


Measurements were repeated after 45days .


Body mass index ( BMI ) , waist and hip circumferences , serum insulin , lipoprotein and insulin resistance measures were significantly higher , and plasma nesfatin-1 level was significantly lower , in obese patients than in normal weight controls .


In addition , negative correlations were found between plasma nesfatin-1 level and BMI , waist and hip circumferences .


Weight reduction in participants after acupuncture and diet restriction was 7.0 % and 4.3 % , respectively .


Plasma nesfatin-1 level increased from 2.751.16 to 3.441.28 ng/mL and from 2.861.07 to 3.231.06 ng/mL in acupuncture and diet groups , respectively ; the difference was significant , p < 0.05 .


Plasma nesfatin-1 level is reduced in obese adults , and is increased after acupuncture .


The beneficial effect of acupuncture on obesity is associated with increased plasma nesfatin-1 level .


Fibromyalgia and major depressive disorder ( MDD ) frequently co-occur .


Quetiapine fumarate extended-release ( quetiapine XR ) has demonstrated efficacy in the treatment of MDD and has been shown to have analgesic properties in patients with depression .


The primary objectives of this study were to evaluate the effects of quetiapine XR on depressive and pain symptoms in patients with MDD and comorbid fibromyalgia , and to assess its safety and tolerability .


This was an 8-week , single-center , double-blind , randomized , controlled trial .


A total of 120 nonpsychotic adult outpatients who fulfilled the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition diagnostic criteria for MDD and whose diagnosis of fibromyalgia was confirmed according to the American College of Rheumatology criteria were enrolled .


The primary end point was the mean change from baseline to week 8 on the 17-item Hamilton Depression Rating ( HAM-D ) scale .


Secondary end points included other depression-rating scores , pain scores , fibromyalgia scores , measures of quality of life and global functioning , and adverse events .


The mean change in the HAM-D score from baseline to week 8 was significantly greater in the quetiapine XR group compared with the placebo group ( -10.0 versus -5.8 ; P = 0.001 ) .


Improvements in most secondary outcomes were also significantly greater in the quetiapine XR group .


Quetiapine XR was generally well tolerated .


This study is the first to demonstrate that measures of depression , pain , and quality of life are significantly improved with quetiapine XR compared with placebo in patients with a dual diagnosis of MDD and fibromyalgia .


This article reports the effects of three evidence-based interventions of varying intensity , each designed to improve outcomes of hospitalized cognitively impaired older adults .


In this comparative effectiveness study , 202 older adults with cognitive impairment ( assessed within 24 h of index hospitalization ) were enrolled at one of three hospitals within an academic health system .


Each hospital was randomly assigned one of the following interventions : Augmented Standard Care ( ASC ; lower dose : n = 65 ) , Resource Nurse Care ( RNC ; medium dose : n = 71 ) or the Transitional Care Model ( TCM ; higher dose : n = 66 ) .


Since randomization at the patient level was not feasible due to potential contamination , generalized boosted modeling that estimated multigroup propensity score weights was used to balance baseline patient characteristics between groups .


Analyses compared the three groups on time with first rehospitalization or death , the number and days of all-cause rehospitalizations per patient and functional status through 6-month postindex hospitalization .


In total , 25 % of the ASC group were rehospitalized or died by day 33 compared with day 58 for the RNC group versus day 83 for the TCM group .


The largest differences between the three groups on time to rehospitalization or death were observed early in the Kaplan-Meier curve ( at 30 days : ASC = 22 % vs RNC = 19 % vs TCM = 9 % ) .


The TCM group also demonstrated lower mean rehospitalization rates per patient compared with the RNC ( p < 0.001 ) and ASC groups ( p = 0.06 ) at 30 days .


At 90-day postindex hospitalization , the TCM group continued to demonstrate lower mean rehospitalization rates per patient only when compared with the ASC group ( p = 0.02 ) .


No significant group differences in functional status were observed .


Findings suggest that the TCM intervention , compared with interventions of lower intensity , has the potential to decrease costly resource use outcomes in the immediate postindex hospitalization period among cognitively impaired older adults .


Although electroconvulsive therapy ( ECT ) is the most effective acute antidepressant intervention , sustained response rates are low .


It has never been systematically assessed whether psychotherapy , continuation ECT , or antidepressant medication is the most efficacious intervention to maintain initial treatment response .


In a prospective , randomized clinical trial , 90 inpatients with major depressive disorder ( MDD ) were treated with right unilateral ultra-brief acute ECT .


Electroconvulsive therapy responders received 6 months guideline-based antidepressant medication ( MED ) and were randomly assigned to add-on therapy with cognitive-behavioral group therapy ( CBT-arm ) , add-on therapy with ultra-brief pulse continuation electroconvulsive therapy ( ECT-arm ) , or no add-on therapy ( MED-arm ) .


After the 6 months of continuation treatment , patients were followed-up for another 6 months .


The primary outcome parameter was the proportion of patients who remained well after 12 months .


Of 90 MDD patients starting the acute phase , 70 % responded and 47 % remitted to acute ECT .


After 6 months of continuation treatment , significant differences were observed in the three treatment arms with sustained response rates of 77 % in the CBT-arm , 40 % in the ECT-arm , and 44 % in the MED-arm .


After 12 months , these differences remained stable with sustained response rates of 65 % in the CBT-arm , 28 % in the ECT-arm , and 33 % in the MED-arm .


These results suggest that ultra-brief pulse ECT as a continuation treatment correlates with low sustained response rates .


However , the main finding implicates cognitive-behavioral group therapy in combination with antidepressants might be an effective continuation treatment to sustain response after successful ECT in MDD patients .


Spinal anesthesia ( SA ) is usually associated with hypotension in pregnant women .


We sought to assess the influence of various maternal positions on SA-induced hypotension


The study population comprised 99 women at full-term gestation scheduled for elective cesarean section .


They were randomized into 3 equal groups : the LL group , in which the patient was placed in the full left-lateral position until the start of surgery with the Whitacre needle bevel oriented laterally ; the LS group , in which the patient was placed in the full left-lateral position initially and then shifted to the left-tilt supine position with the needle bevel oriented laterally ; and the CS group , in which the patient was initially placed in the full left-lateral position and then shifted to the left-tilt supine position with the needle oriented in the cephalad direction .


The incidences of hypotension in the LL , LS , and CS groups were 9.7 % , 54.8 % , and 56.3 % , respectively .


Ephedrine requirements were lower in the LL group than in the LS group ( P < 0.01 ) .


The maternal position during the induction of anesthesia played an important role in the development of hypotension during cesarean delivery .


Adolescent smoking is still highly prevalent in Denmark .


One in four 13-year olds indicates that they have tried to smoke , and one in four 15-year olds answer that they smoke regularly .


Smoking is more prevalent in socioeconomically disadvantaged populations in Denmark as well as in most Western countries .


Previous school-based programs to prevent smoking have shown contrasting results internationally .


In Denmark , previous programs have shown limited or no effect .


This indicates a need for developing a well-designed , comprehensive , and multi-component intervention aimed at Danish schools with careful implementation and thorough evaluation.This paper describes X : IT , a study including 1 ) the development of a 3-year school-based multi-component intervention and 2 ) the randomized trial investigating the effect of the intervention .


The study aims at reducing the prevalence of smoking among 13 to 15-year olds by 25 % .


The X : IT study is based on the Theory of Triadic Influences .


The theory organizes factors influencing adolescent smoking into three streams : cultural environment , social situation , and personal factors .


We added a fourth stream , the community aspects .


The X : IT program comprises three main components : 1 ) smoke-free school premises , 2 ) parental involvement including smoke-free dialogues and smoke-free contracts between students and parents , and 3 ) a curricular component .


The study encompasses process - and effect-evaluations as well as health economic analyses .


Ninety-four schools in 17 municipalities were randomly allocated to the intervention ( 51 schools ) or control ( 43 schools ) group .


At baseline in September 2010 , 4,468 year 7 students were eligible of which 4,167 answered the baseline questionnaire ( response rate = 93.3 % ) .


The X : IT study is a large , randomized controlled trial evaluating the effect of an intervention , based on components proven to be efficient in other Nordic settings .


The X : IT study directs students , their parents , and smoking prevention policies at the schools .


These elements have proven to be effective tools in preventing smoking among adolescents .


Program implementation is thoroughly evaluated to be able to add to the current knowledge of the importance of implementation .


X : IT creates the basis for thorough effect and process evaluation , focusing on various social groups .


Current Controlled Trials ISRCTN77415416 .


Advanced oxidation protein products ( AOPP ) are newly identified efficient oxidative stress biomarkers .


In a longitudinal birth cohort the effects were investigated of genetic polymorphisms in five oxidative pathway genes on AOPP levels .


This study is part of a three-arm randomized , double-blind , placebo-controlled trial .


Three hundred and twelve children were included in the present study with AOPP levels measured at 2.5 , 5.5 , 10.5 , 15 and 24 months of age .


Twelve polymorphisms were genotyped in five oxidative stress pathway genes : glutathione reductase ( GSR ) , glutamylcysteine synthetase ( GCLC ) , glutathione S-transferase ( GST ) P1 , haem oxygenase 1 ( HMOX1 ) and superoxide dismutase 2 ( SOD2 ) in 298 children .


There were 284 children assessed for anaemia and clinical malaria infection at the age of 24 months .


Two principal components ( PCA1 and PCA2 ) were derived from the AOPP levels measured at the five time points .


PCA1 was significantly associated with anaemia ( p = 0.0002 ) , and PCA2 with clinical malaria infection ( p = 0.047 ) .


In the K-Means Cluster Analysis based on levels of AOPP , children were clustered into two groups : Group A ( lower AOPP levels ) and Group B ( higher AOPP levels ) .


The cluster membership was significantly associated with anaemia ( p = 0.003 ) as well as with the GSR RS3594 polymorphism ( p = 0.037 ) .


Mixed linear regression analyses found that the single nucleotide polymorphisms GCLC RS10948751 and HMOX1 RS17885925 were significantly associated with AOPP levels ( p = 0.030 and p = 0.027 , respectively ) .


Plasma AOPP levels were predictive for anaemia and oxidative stress markers for clinical malaria infection in two year old children .


Several polymorphisms in GCLC , GSR and HMOX1 genes were associated with oxidative stress status of these children .


Whole-grain ( WG ) foods have been suggested to reduce the risk of cardiovascular disease , but studies are inconsistent and effects on cardiovascular risk markers are not clear .


The objective of this study was to assess the impact of increasing WG consumption to at least 80 g/d on overall dietary intake , body composition , blood pressure ( BP ) , blood lipids , blood glucose , gastrointestinal microbiology , and gastrointestinal symptoms in healthy , middle-aged adults with habitual WG intake < 24 g/d .


Eligible subjects [ 12 men , 21 women , aged 40-65 y , body mass index ( BMI ) : 20-35 kg/m ( 2 ) ] were identified through use of food frequency questionnaires and subsequently completed 3-day food diaries ( 3DFDs ) to confirm habitual WG consumption .


Subjects consumed diets high in WG ( > 80 g/d ) or low in WG [ < 16 g/d , refined-grain ( RG ) diet ] in a crossover study with 6-wk intervention periods separated by a 4-wk washout .


Adherence was achieved by specific dietary advice and provision of a range of cereal food products .


The 3DFDs , diet compliance diaries , and plasma alkylresorcinols were used to verify compliance .


During the WG intervention , consumption increased from 28 g/d to 168 g/d ( P < 0.001 ) , accompanied by an increase in plasma alkylresorcinols ( P < 0.001 ) and total fiber intake ( P < 0.001 ) , without any effect on energy or other macronutrients .


Although there were no effects on studied variables , there were trends toward increased 24-h fecal weight ( P = 0.08 ) and reduction in body weight ( P = 0.10 ) and BMI ( P = 0.08 ) during the WG intervention compared with the RG period .


A combination of dietary advice and provision of commercially available food items enabled subjects with a low-moderate habitual consumption of WG to substantially increase their WG intake , but there was little effect on blood biochemical markers , body composition , BP , fecal measurements , or gut microbiology .


This trial was registered at www.controlled-trials.com as ISRCTN36521837 .


Biochemical control reduces morbidity and increases life expectancy in patients with acromegaly .


With current medical therapies , including the gold standard octreotide long-acting-release ( LAR ) , many patients do not achieve biochemical control .


Our objective was to demonstrate the superiority of pasireotide LAR over octreotide LAR in medically naive patients with acromegaly .


We conducted a prospective , randomized , double-blind study at 84 sites in 27 countries .


A total of 358 patients with medically naive acromegaly ( GH > 5 g/L or GH nadir 1 g/L after an oral glucose tolerance test ( OGTT ) and IGF-1 above the upper limit of normal ) were enrolled .


Patients either had previous pituitary surgery but no medical treatment or were de novo with a visible pituitary adenoma on magnetic resonance imaging .


Patients received pasireotide LAR 40 mg/28 days ( n = 176 ) or octreotide LAR 20 mg/28 days ( n = 182 ) for 12 months .


At months 3 and 7 , titration to pasireotide LAR 60 mg or octreotide LAR 30 mg was permitted , but not mandatory , if GH 2.5 g/L and/or IGF-1 was above the upper limit of normal .


The main outcome measure was the proportion of patients in each treatment arm with biochemical control ( GH < 2.5 g/L and normal IGF-1 ) at month 12 .


Biochemical control was achieved by significantly more pasireotide LAR patients than octreotide LAR patients ( 31.3 % vs 19.2 % ; P = .007 ; 35.8 % vs 20.9 % when including patients with IGF-1 below the lower normal limit ) .


In pasireotide LAR and octreotide LAR patients , respectively , 38.6 % and 23.6 % ( P = .002 ) achieved normal IGF-1 , and 48.3 % and 51.6 % achieved GH < 2.5 g/L .


31.0 % of pasireotide LAR and 22.2 % of octreotide LAR patients who did not achieve biochemical control did not receive the recommended dose increase .


Hyperglycemia-related adverse events were more common with pasireotide LAR ( 57.3 % vs 21.7 % ) .


Pasireotide LAR demonstrated superior efficacy over octreotide LAR and is a viable new treatment option for acromegaly .


We examined whether IV administration of cyclosporine in combination with thrombolysis might reduce cerebral infarct size .


Patients aged 18 to 85 years , presenting with an anterior-circulation stroke and eligible for thrombolytic therapy , were enrolled in this multicenter , single-blinded , controlled trial .


Fifteen minutes after randomization , patients received either an IV bolus injection of 2.0 mg/kg cyclosporine ( Sandimmune , Novartis ) or placebo .


The primary endpoint was infarct volume on MRI at 30 days .


Secondary endpoints included infarct volume according to the site ( proximal/distal ) of arterial occlusion and recanalization after thrombolysis .


From October 2009 to July 2013 , 127 patients were enrolled .


The primary endpoint was assessed in 110 of 127 patients .


The reduction of infarct volume in the cyclosporine compared with the control group was overall not significant ( 21.8 mL [ interquartile range , IQR 5.1 , 69.2 mL ] vs 28.8 mL [ IQR 7.7 , 95.0 mL ] , respectively ; p = 0.18 ) .


However , in patients with proximal occlusion and effective recanalization , infarct volume was significantly reduced in the cyclosporine compared with the control group ( 14.9 mL [ IQR 1.3 , 23.2 mL ] vs 48.3 mL [ IQR 34.5 , 118.2 mL ] , respectively ; p = 0.009 ) .


Cyclosporine was generally not effective in reducing infarct size .


However , a smaller infarct size was observed in patients with proximal cerebral artery occlusion and efficient recanalization .


This study provides Class I evidence that in patients with an acute anterior-circulation stroke , thrombolysis plus IV cyclosporine does not significantly decrease 30-day MRI infarct volume compared with thrombolysis alone .