We assessed the associations of use of dexamethasone , smoking status and alcohol abuse with the primary outcome , being a composite of SSI , anastomotic leak , wound dehiscence , burst abdomen and 30-day mortality .


The primary outcome occurred in 21 % of patients receiving dexamethasone versus 28 % of patients not receiving dexamethasone , and this was not statistically significant when adjusting for stratification variables originally used in the PROXI trial [ OR 0.90 , 95 % CI ( 0.65-1 .24 ) ] .


In smokers , the primary outcome occurred in 32 % , compared with 23 % of non-smokers ( P = 0.0001 ) .


Smokers also had a higher frequency of SSI ( 25 % vs 17 % , P < 0.0001 ) and burst abdomen ( 3.8 % vs 2.4 % , P = 0.04 ) .


In alcohol abusers , the primary outcome occurred in 48 % , compared with 25 % in patients who did not abuse alcohol ( P = 0.0006 ) .


Burst abdomen occurred more commonly in alcohol abusers ( 15 % vs 2.3 % , P < 0.0001 ) .


Perioperative administration of dexamethasone was not significantly associated with SSI or other wound-related complications .


Conversely , smoking and alcohol abuse were both significant predictors of the primary outcome consisting of wound-related complications and mortality .


While research suggests primary prescription opioid ( PO ) abusers may exhibit less severe demographic and drug use characteristics than primary heroin abusers , less is known about whether a lifetime history of heroin use confers greater severity among PO abusers .


In this secondary analysis , we examined demographic and drug use characteristics as a function of lifetime heroin use among 89 PO-dependent adults screened for a trial evaluating the relative efficacy of buprenorphine taper durations .


Exploratory analyses also examined contribution of lifetime heroin use to treatment response among a subset of participants who received a uniform set of study procedures .


Baseline characteristics were compared between participants reporting lifetime heroin use 5 ( H ( + ) ; n = 41 ) vs. < 5 ( H ( - ) ; n = 48 ) times .


Treatment response ( i.e. , illicit opioid abstinence and treatment retention at end of study ) was examined in the subset of H ( + ) and H ( - ) participants randomized to receive the 4-week taper condition ( N = 22 ) .


H ( + ) participants were significantly older and more likely to be male .


They reported longer durations of illicit opioid use , greater alcohol-related problems , more past-month cocaine use , greater lifetime IV drug use , and greater lifetime use of cigarettes , amphetamines and hallucinogens .


H ( + ) participants also had lower scores on the Positive Symptom Distress and Depression subscales of the Brief Symptom Inventory .


Finally , there was a trend toward poorer treatment outcomes among H ( + ) participants .


A lifetime history of heroin use may be associated with elevated drug severity and unique treatment needs among treatment-seeking PO abusers .


To evaluate the onset and duration of improvement in best-corrected visual acuity ( BCVA ) in eyes treated with dexamethasone intravitreal implant 0.7 mg ( DEX implant ) for macular edema after branch or central retinal vein occlusion .


Post hoc analysis of data from 2 previously reported multicenter , 6-month , randomized sham-controlled clinical trials .


Patients received a single DEX implant ( n = 427 ) or sham procedure ( n = 426 ) in the study eye .


The primary endpoint was the percentage of eyes with 15-letter improvement in BCVA from baseline at postimplant Day 7 .


The baseline mean BCVA was 20/80 .


At Day 7 , 10.3 % of DEX implant-treated eyes versus 4.0 % of sham-treated eyes ( P < 0.001 ) had 15-letter improvement in the BCVA , and 27.2 % of DEX implant-treated eyes versus 10.6 % of sham-treated eyes had 10-letter improvement ( P < 0.001 ) .


The mean improvement at Day 7 was 5.3 letters ( branch retinal vein occlusion , 5.1 ; and central retinal vein occlusion , 5.8 ) with DEX implant and 1.6 letters ( branch retinal vein occlusion , 2.3 ; and central retinal vein occlusion , 0.1 ) with sham ( P < 0.001 ) .


The mean time from initial observation of 15-letter BCVA gain to the last observation of 15-letter BCVA gain was 70 days .


Dexamethasone intravitreal implant treatment led to improvement in BCVA compared with sham procedure as early as postimplant Day 7 .


The duration of 3-line improvement was typically 2 to 3 months .


To investigate the effect of luteal phase support with vaginal progesterone on pregnancy rates of the gonadotropin-stimulated intrauterine insemination ( IUI ) cycles in patients with unexplained infertility with regard tofollicular growth .


A total of 149 patients with unexplained infertility who underwent 166 recombinant follicle stimulated hormone -- stimulated IUI cycles were prospectively randomized into 2 groups for luteal phase support .


The study group ( n = 71 ) received vaginal progesterone gel supplementation , and the control group ( n = 78 ) received no drug for luteal support .


The clinical pregnancy rates and live birth rates per cycle and per patient were compared between the groups .


The differences between the groups with regard to clinical pregnancy rates and live birth rates per patient or per cycle were not different among all patients .


In cycles with > 1 dominant follicle ( multifollicular response ) , the clinical pregnancy rate per patient was significantly higher in the supported cycles as compared with the unsupported cycles ( 28.2 % vs. 11.4 % , respectively , p = 0.04 ) .


Reproductive outcomes in cycles with a single dominant follicle ( monofollicular response ) were not different between supported and unsupported cycles .


Luteal phase support with vaginal progesterone affects the success of gonadotropin-stimulated IUI cycles with multifollicular response but not with monofollicular response .


Linifanib , a potent , selective inhibitor of vascular endothelial growth factor ( VEGF ) and platelet-derived growth factor ( PDGF ) receptors , has single-agent activity in non-small-cell lung cancer ( NSCLC ) .


We evaluated linifanib with carboplatin and paclitaxel as first-line therapy of advanced nonsquamous NSCLC .


Patients with stage IIIB/IV nonsquamous NSCLC were randomly assigned to 3-week cycles of carboplatin ( area under the curve 6 ) and paclitaxel ( 200 mg/m ( 2 ) ) with daily placebo ( arm A ) , linifanib 7.5 mg ( arm B ) , or linifanib 12.5 mg ( arm C ) .


The primary end point was progression-free survival ( PFS ) ; secondary efficacy end points included overall survival ( OS ) and objective response rate .


One hundred thirty-eight patients were randomly assigned ( median age , 61 years ; 57 % men ; 84 % smokers ) .


Median PFS times were 5.4 months ( 95 % CI , 4.2 to 5.7 months ) in arm A ( n = 47 ) , 8.3 months ( 95 % CI , 4.2 to 10.8 months ) in arm B ( n = 44 ) , and 7.3 months ( 95 % CI , 4.6 to 10.8 months ) in arm C ( n = 47 ) .


Hazard ratios ( HRs ) for PFS were 0.51 for arm B versus A ( P = .022 ) and 0.64 for arm C versus A ( P = .118 ) .


Median OS times were 11.3 , 11.4 , and 13.0 months in arms A , B , and C , respectively .


HRs for OS were 1.08 for arm B versus A ( P = .779 ) and 0.88 for arm C versus A ( P = .650 ) .


Both linifanib doses were associated with increased toxicity , including a higher incidence of adverse events known to be associated with VEGF/PDGF inhibition .


Baseline plasma carcinoembryonic antigen/cytokeratin 19 fragments biomarker signature was associated with PFS improvement and a trend toward OS improvement with linifanib 12.5 mg .


Addition of linifanib to chemotherapy significantly improved PFS ( arm B ) , with a modest trend for survival benefit ( arm C ) and increased toxicity reflective of known VEGF/PDGF inhibitory effects .


To compare the effects of two of the most effective lipid-lowering therapies with similar LDL-cholesterol reduction capacity on the innate and adaptive immune responses through the evaluation of autoantibodies anti-oxidized LDL ( anti-oxLDL Abs ) and electronegative LDL [ LDL ( - ) ] levels .


We performed a prospective , randomized , open label study , with parallel arms and blinded endpoints .


One hundred and twelve subjects completed the study protocol and received rosuvastatin 40 mg or ezetimibe/simvastatin 10/40 mg for 12 weeks .


Lipids , apolipoproteins , LDL ( - ) , and anti-oxLDL Abs ( IgG ) were assayed at baseline and end of study .


Main clinical and laboratory characteristics were comparable at baseline .


Lipid modifications were similar in both treatment arms , however , a significant raise in anti-oxLDL Abs levels was observed in subjects treated with rosuvastatin ( p = 0.026 vs. baseline ) , but not in those receiving simvastatin/ezetimibe .


( p = 0.233 vs. baseline ) , thus suggesting modulation of adaptive immunity by a potent statin .


Titers of LDL ( - ) were not modified by the treatments .


Considering atherosclerosis as an immune disease , this study adds new information , showing that under similar LDL-cholesterol reduction , the choice of lipid-lowering therapy can differently modulate adaptive immune responses .


The aim of the study was to compare two techniques of pyramidalis muscle dissection during cesarean section .


A total of 108 patients undergoing a cesarean section were randomly allocated to group I ( N = 57 ) , with the pyramidalis muscle left attached to the rectus muscles , and group II ( N = 51 ) , with preservation of the connection between the pyramidalis muscle and the rectus sheath .


There were no statistically significant differences between the groups regarding surgery duration , blood loss and postoperative pain .


After three months , patients from group II more frequently reported paresthesia in the scar region ( 47.1 vs. 28.1 % ; p = 0.041 ) , but their self-assessment of the abdominal appearance and presence of the bulging below the wound were comparable with group I.


None of the two techniques of pyramidalis muscle dissection appear to be superior to the other .


The technique leaving the pyramidalis muscle attached to the fascia gave more frequent paresthesia during a 3-month follow-up .


The importance of functional properties of high-density lipoproteins ( HDL ) for atheroprotection is increasingly recognized .


We determined the impact of lipid-lowering therapy on 3 key HDL functionalities in Type 2 diabetes mellitus ( T2DM ) .


A placebo-controlled , randomized cross-over study ( three 8-week treatment periods with simvastatin ( 40 mg daily ) , bezafibrate ( 400 mg daily ) , alone and in combination ) was carried out in 14 men with T2DM .


Cholesterol efflux was determined using human THP-1 monocyte-derived macrophages , HDL antioxidative capacity was measured as inhibition of low-density lipoprotein oxidation in vitro , and HDL anti-inflammatory capacity was assessed as suppression of thrombin-induced monocyte chemotactic protein 1 expression in human umbilical vein endothelial cells .


Pre -- HDL was assayed using crossed immunoelectrophoresis .


While cholesterol efflux increased in response to simvastatin , bezafibrate and combination treatment ( +12 to +23 % ; anova , P = 0.001 ) , HDL antioxidative capacity ( P = 0.23 ) and HDL anti-inflammatory capacity ( P = 0.15 ) did not change significantly .


Averaged changes in cellular cholesterol efflux during active treatment were correlated positively with changes in HDL cholesterol , apoA-I and pre -- HDL ( P < 0.05 to P < 0.001 ) .


There were no inter-relationships between changes in the three HDL functionalities during treatment ( P > 0.10 ) .


Changes in HDL antioxidative capacity and anti-inflammatory capacity were also unrelated to changes in HDL cholesterol and apoA-I , while changes in HDL antioxidative capacity were related inversely to pre -- HDL ( P < 0.05 ) .


Simvastatin and bezafibrate increase cholesterol efflux , parallel to HDL cholesterol and apoA-I responses .


The antioxidative and anti-inflammatory properties of HDL are not to an important extent affected by these therapeutic interventions .


Regulatory Foxp3-expressing T cells ( Tregs ) , IL-10-producing B cells ( Bregs ) , and IDO-expressing dendritic cells ( DCregs ) downregulate inflammatory processes and induce peripheral tolerance , while Th17A and Th22 cell subpopulations are of proinflammatory nature .


The aims of the study were to characterize and to enumerate peripheral Tregs , Bregs , and DCregs and Th17A and Th22 cell subpopulations in kidney transplant recipients ( KTRs ) under belatacept or cyclosporine treatment .


Forty-one KRT patients ( 30 under belatacept treatment and 11 under cyclosporine treatment ) and 26 healthy donors ( HDs ) were included in the study .


CD19 ( + ) - expressing peripheral B lymphocytes were purified by positive selection .


IL-10-producing B cells , CD4 ( + ) / CD25 ( high ) Foxp3 ( + ) , and CD8 ( + ) / CD28 ( - ) Foxp3 ( + ) Tregs , CCR6 ( + ) / CD123 ( + ) / IDO ( + ) DCs , as well as Th17A and Th22 cell subpopulations were quantitated by flow cytometry .


Of the IL-10-producing Bregs , CD19 ( + ) / CD24 ( high ) / CD38 ( high ) / CD5 ( + ) , CD19 ( + ) / CD24 ( high ) / CD38 ( high ) / CD10 ( + ) , CD19 ( + ) / CD24 ( high ) / CD38 ( high ) / CD20 ( + ) , and CD19 ( + ) / CD24 ( high ) / CD38 ( high ) / CD27 ( - ) had significant higher frequency in patients under belatacept treatment when compared with those under cyclosporine .


Only CD19 ( + ) / CD24 ( high ) / CD38 ( high ) / CD27 ( + ) and CD19 ( + ) / CD24 ( high ) / CD38 ( high ) / CXCR7 ( + ) cells had significant higher frequency in patients under cycloporine treatment when compared to those under belatacept .


The percentages of IDO-expressing pDC , CD4 ( + ) / CD25 ( high ) Foxp3 ( + ) , and CD8 ( + ) / CD28 ( - ) Foxp3 ( + ) were significantly higher in the belatacept group when compared the cyclosporine one , while Th17A and Th22 cells had significant higher frequency in the latter group .


Belatacept seems to maintain and enhance , at least systemically , a tolerant profile to renal allograft in transplant recipients by means of higher circulatory frequencies of regulatory B , T and pDC subpopulations .


In the United Kingdom , patients with locally advanced rectal cancer routinely receive neoadjuvant chemoradiotherapy .


However , the effects of this on physical fitness are unclear .


This pilot study is aimed to investigate the effect of neoadjuvant chemoradiotherapy on objectively measured in vivo muscle mitochondrial function and whole-body physical fitness .


We prospectively studied 12 patients with rectal cancer who completed standardized neoadjuvant chemoradiotherapy , recruited from a large tertiary cancer centre , between October 2012 and July 2013 .


All patients underwent a cardiopulmonary exercise test and a phosphorus magnetic resonance spectroscopy quadriceps muscle exercise-recovery study before and after neoadjuvant chemoradiotherapy .


Data were analysed and reported blind to patient identity and clinical course .


Primary variables of interest were the two physical fitness measures ; oxygen uptake at estimated anaerobic threshold and oxygen uptake at Peak exercise ( ml.kg-1 .


min-1 ) , and the post-exercise phosphocreatine recovery rate constant ( min-1 ) , a measure of muscle mitochondrial capacity in vivo .


Median age was 67 years ( IQR 64-75 ) .


Differences ( 95 % CI ) in all three primary variables were significantly negative post-NACRT : Oxygen uptake at estimated anaerobic threshold -2.4 ml.kg-1 .


min-1 ( -3.8 , -0.9 ) , p = 0.004 ; Oxygen uptake at Peak -4.0 ml.kg-1 .


min-1 ( -6.8 , -1.1 ) , p = 0.011 ; and post-exercise phosphocreatine recovery rate constant -0.34 min-1 ( -0.51 , -0.17 ) , p < 0.001 .


The significant decrease in both whole-body physical fitness and in vivo muscle mitochondrial function raises the possibility that muscle mitochondrial mechanisms , no doubt multifactorial , may be important in deterioration of physical fitness following neoadjuvant chemoradiotherapy .


This may have implications for targeted interventions to improve physical fitness pre-surgery .


Clinicaltrials.gov registration NCT01859442 .


To evaluate the effect of periodontal treatment on gingival overgrowth in a group of renal transplant patients .


Twenty-five renal transplant recipients receiving immunosuppressive therapy with cyclosporine A ( CsA ) were randomly assigned to 2 groups .


Group 1 ( n = 15 ) included patients who had been specifically referred to a dental clinic to prevent gingival overgrowth and were given full periodontal therapy .


Group 2 ( n = 10 ) was comprised of patients who did not receive any professional periodontal cleaning .


Patients from both groups were examined to determine their periodontal status before and after 3 , 6 and 12 months in terms of their plaque index , gingival index and gingival overgrowth .


During the examination , their overall health was stable .


For group 1 , the scores were 1.89 ( baseline ) , 0.98 ( 6 months ) and 0.56 ( 12 months ) , and hence there were significant reductions ( p = 0.0001 ) .


The gingival indices were 1.71 ( baseline ) , 0.76 ( 6 months ) and 0.35 ( 12 months ) , and the reductions were also significant ( p = 0.0001 ) .


A significant association was observed between poor oral hygiene and the degree of gingival overgrowth .


The 1-year post-treatment follow-up showed that patients in group 1 did not develop gingival overgrowth due to the use of CsA as group 2 did without prior periodontal therapy .


Oral hygiene status was the most important variable related to the development and degree of gingival overgrowth due to the use of CsA .


The use of heat and moisture exchangers ( HME ) during noninvasive ventilation ( NIV ) can increase the work of breathing , decrease alveolar ventilation , and deliver less humidity in comparison with heated humidifiers ( HH ) .


We tested the hypothesis that the use of HH during NIV with ICU ventilators for patients with acute respiratory failure would decrease the rate of intubation ( primary endpoint ) as compared with HME .


We conducted a multicenter randomized controlled study in 15 centers .


After stratification by center and type of respiratory failure ( hypoxemic or hypercapnic ) , eligible patients were randomized to receive NIV with HH or HME .


Of the 247 patients included , 128 patients were allocated to the HME group and 119 to the HH group .


Patients were comparable at baseline .


The intubation rate was not significantly different : 29.7 % in the HME group and 36.9 % in the HH group ( p = 0.28 ) .


PaCO2 did not significantly differ between the two arms , even in the subgroup of hypercapnic patients .


No significant difference was observed for NIV duration , ICU and hospital LOS , or ICU mortality ( HME 14.1 vs. HH 21.5 % , p = 0.18 ) .


In this study , the short-term physiological benefits of HH in comparison with HME during NIV with ICU ventilators were not observed , and no difference in intubation rate was found .


The physiologic effects may have been obscured by leaks or other important factors in the clinical settings .


This study does not support the recent recommendation favoring the use of HH during NIV with ICU ventilators .


Chronic pain can disrupt the cortical representation of a painful body part .


This disruption may play a role in maintaining the individual 's pain .


Tactile acuity training has been used to normalise cortical representation and reduce pain in certain pain conditions .


However , there is little evidence for the effectiveness of this intervention for chronic low back pain ( CLBP ) .


The primary aim of this study was to inform the development of a fully powered randomised controlled trial ( RCT ) by providing preliminary data on the effect of tactile acuity training on pain and function in individuals with CLBP .


The secondary aim was to obtain qualitative feedback about the intervention .


In this mixed-methods pilot RCT 15 individuals were randomised to either an intervention ( tactile acuity training ) or a placebo group ( sham tactile acuity training ) .


All participants received 3 sessions of acuity training ( intervention or sham ) from a physiotherapist and were requested to undertake daily acuity home training facilitated by an informal carer ( friend/relative ) .


All participants also received usual care physiotherapy .


The primary outcome measures were pain ( 0-100visual analogue scale ( VAS ) ) and function ( Roland Morris Disability Questionnaire ( RMDQ ) ) .


Participants and their informal carers were invited to a focus group to provide feedback on the intervention .


The placebo group improved by the greatest magnitude for both outcome measures , but there was no statistically significant difference ( Mean difference ( 95 % CI ) , p-value ) between groups for change in pain ( 25.6 ( -0.7 to 51.9 ) , p = 0.056 ) or function ( 2.2 ( -1.6 to 6.0 ) , p = 0.237 ) .


Comparing the number of individuals achieving a minimally clinically significant improvement , the placebo group had better outcomes for pain with all participants achieving 30 % improvement compared to only a third of the intervention group ( 6/6 vs. 3/9 , p = 0.036 ) .


Qualitatively , participants reported that needing an informal carer was a considerable barrier to the home training component of the study .


This pilot RCT found tactile acuity training to be no more effective than sham tactile acuity training for function and less effective for pain in individuals with CLBP .


That the intervention could not be self-applied was a considerable barrier to its use .


ISRCTN98118082 .


Chronic obstructive pulmonary disease ( COPD ) is a chronic , progressively debilitating condition that is prevalent in the US and worldwide .


Patients suffer from progressive dyspnea and exercise intolerance .


Physical exercise is beneficial , but conventional pulmonary rehabilitation programs are underutilized .


There remains a need for novel interventions that improve symptoms , quality-of-life , and functional capacity .


Tai chi is an increasingly popular mind-body exercise that includes physical exercise , breathing training , mindful awareness , and stress management -- components that are essential to the self-management of COPD .


There are , however , limited data on the effectiveness of tai chi as a therapeutic intervention in this population .


The Primary Aims are to evaluate the efficacy , safety , and feasibility of a 12-week tai chi program for patients with COPD .


We utilize a randomized controlled trial design , with participants assigned in a 2:1 ratio to either a group tai chi program ( N = 63 ) or a time/attention-matched education control ( N = 31 ) .


Our primary outcomes are COPD-specific quality-of-life and exercise capacity .


Secondary outcomes include dyspnea , mood , functional status , self-efficacy , and lung function .


Cardiopulmonary exercise testing is done in a subset of patients ( N = 50 ) .


To explore optimal training duration , a subgroup of patients in tai chi are randomly assigned to complete an additional 12 weeks training ( total 24 weeks ) ( Exploratory Aim 1 ) .


To explore the impact of a simplified seated intervention including only a subset of tai chi 's training components , a third randomly assigned group ( N = 31 ) receives a 12 - week mind-body breathing program ( N = 31 ) ( Exploratory Aim 2 ) .


Results of the BEAM study ( Breathing , Education , Awareness , Movement ) will provide preliminary evidence regarding the value of tai chi for improving quality of life and exercise capacity in patients with COPD , including information regarding optimal duration .


They will also inform the feasibility and potential benefit of an alternative mind-body breathing intervention , and provide insight regarding how isolated mind-body exercise components contribute to the overall effects of tai chi .


Should the results be positive , tai chi and related mind-body practices may offer a novel exercise option that is potentially accessible to a large proportion of patients with COPD .


This trial is registered in Clinical Trials.gov , ID number NCT01551953 .


Date of Registration March 1 2012 .


To determine whether a pharmacist-led medications review in primary care reduces the number of drugs and the number of drug-related problems .


Prospective randomized controlled trial .


Liljeholmen Primary Care Centre , Stockholm , Sweden .


209 patients aged 65 years with five or more different medications .


Intervention .


Patients answered a questionnaire regarding medications .


The pharmacist reviewed all medications ( prescription , non-prescription , and herbal ) regarding recommendations and renal impairment , giving advice to patients and GPs .


Each patient met the pharmacist before seeing their GP .


Control patients received their usual care .


Drug-related problems and number of drugs .


Secondary outcomes included health care utilization and self-rated health during 12 months of follow-up .


No significant difference was seen when comparing change in drug-related problems between the groups .


However , a significant decrease in drug-related problems was observed in the intervention group ( from 1.73 per patient at baseline to 1.31 at follow-up , p < 0.05 ) .


The change in number of drugs was more pronounced in the intervention group ( p < 0.046 ) .


Intervention group patients were not admitted to hospital on fewer occasions or for fewer days , and there was no significant difference between the two groups regarding utilization of primary care during follow-up .


Self-rated health remained unchanged in the intervention group , whereas a drop ( p < 0.02 ) was reported in the control group .


This resulted in a significant difference in change in self-rated health between the groups ( p < 0.047 ) .


The addition of a skilled pharmacist to the primary care team may contribute to reductions in numbers of drugs and maintenance of self-rated health in elderly patients with polypharmacy .


Exercise evokes pulsatile GH release followed by autonegative feedback , whereas glucose suppresses GH release followed by rebound-like GH release ( feedforward escape ) .


Here we test the hypothesis that age , sex steroids , insulin , body composition and physical power jointly determine these dynamic GH responses .


This was a prospectively randomized glucose-blinded study conducted in the Mayo Center for Advancing Translational Sciences in healthy men ages 19-77 years ( N = 23 ) .


Three conditions , fasting/rest/saline , fasting/exercise/saline and fasting/rest/iv glucose infusions , were used to drive GH dynamics during 10-min blood sampling for 6h .


Linear correlation analysis was applied to relate peak/nadir GH dynamics to age , sex steroids , insulin , CT-estimated abdominal fat and physical power ( work per unit time ) .


Compared with the fasting/rest/saline ( control ) day , fasting/exercise/saline infusion evoked peak GH within 1h , followed by negative feedback 3-5h later .


The dynamic GH excursion was strongly ( R ( 2 ) = 0.634 ) influenced by ( i ) insulin negatively ( P = 0.011 ) , ( ii ) power positively ( P = 0.0008 ) , and ( iii ) E2 positively ( P = 0.001 ) .


Dynamic glucose-modulated GH release was determined by insulin negatively ( P = 0.0039 ) and power positively ( P = 0.0034 ) ( R ( 2 ) = 0.454 ) .


Under rest/saline , power ( P = 0.031 ) and total abdominal fat ( P = 0.012 ) ( R ( 2 ) = 0.267 ) were the dominant correlates of GH excursions .


In healthy men , dynamic GH perturbations induced by exercise and glucose are strongly related to physical power , insulin , estradiol , and body composition , thus suggesting a network of regulatory pathways .


Observational evidence from behavioral weight control trials and community studies suggests that greater frequency of weighing oneself , or tracking weight , is associated with better weight outcomes .


Conversely , it has also been suggested that frequent weight tracking may have a negative impact on mental health and outcomes during weight loss , but there are minimal experimental data that address this concern in the context of an active weight loss program .


To achieve the long-term goal of strengthening behavioral weight loss programs , the purpose of this randomized controlled trial ( the Tracking Study ) is to test variations on frequency of self-weighing during a behavioral weight loss program , and to examine psychosocial and mental health correlates of weight tracking and weight loss outcomes .


This paper describes the study design , intervention features , recruitment , and baseline characteristics of participants enrolled in the Tracking Study .


Three hundred thirty-nine overweight and obese adults were recruited and randomized to one of three variations on weight tracking frequency during a 12-month weight loss program with a 12-month follow-up : daily weight tracking , weekly weight tracking , or no weight tracking .


The primary outcome is weight in kilograms at 24 months .


The weight loss program integrates each weight tracking instruction with standard behavioral weight loss techniques ( goal setting , self-monitoring , stimulus control , dietary and physical activity enhancements , lifestyle modifications ) ; participants in weight tracking conditions were provided with wireless Internet technology ( wi-fi-enabled digital scales and touchscreen personal devices ) to facilitate weight tracking during the study .


This study was successful in recruiting adult male and female participants and is positioned to enhance the standard of care with regard to weight tracking recommendations .


This Stage II trial builds on a Stage I trial comparing the single-gender Women 's Recovery Group ( WRG ) to mixed-gender Group Drug Counseling ( GDC ) that demonstrated preliminary support for the WRG in treating women with substance use disorders .


The Stage II trial aims were to ( 1 ) investigate effectiveness of the WRG relative to GDC in a sample of women heterogeneous with respect to substance of abuse and co-occurring psychiatric disorders , and ( 2 ) demonstrate the feasibility of implementing WRG in an open-enrollment group format at two sites .


In this randomized clinical trial , participants were included if they were substance dependent and had used substances within the past 60 days ( n = 158 ) .


Women were randomized to WRG ( n = 52 ) or GDC ( n = 48 ) ; men were assigned to GDC ( n = 58 ) .


Substance use outcomes were assessed at months 1-6 and 9 .


Women in both the WRG and GDC had reductions in mean number of substance use days during treatment ( 12.7 vs 13.7 day reductions for WRG and GDC , respectively ) and 6 months post-treatment ( 10.3 vs 12.7 day reductions ) ; however , there were no significant differences between groups .


The WRG demonstrated comparable effectiveness to standard mixed-gender treatment ( i.e. , GDC ) and is feasibly delivered in an open-group format typical of community treatment .


It provides a manual-based group therapy with women-focused content that can be implemented in a variety of clinical settings for women who are heterogeneous with respect to their substance of abuse , other co-occurring psychiatric disorders , and life-stage .


Recently , attention has been paid to dexmedetomidine , a selective -2 adrenoceptor agonist , as a possible additive for local anesthesia .


However , the effect of locally injected dexmedetomidine on the anesthetic action in humans has not fully been clarified .


Thus , the purpose of the present study was to evaluate the effect of dexmedetomidine injected into the oral mucosa in combination with lidocaine on local anesthetic potency in humans .


Twenty healthy volunteers were included in the present crossover double-blinded study .


Lidocaine solution or lidocaine plus dexmedetomidine solution was submucosally injected into the alveolar mucosa in a crossover and double-blinded manner .


The local anesthetic effect of the solutions was evaluated by measuring the current perception threshold ( CPT ) in the oral mucosa for 120 minutes after injection .


Furthermore , the sedation level , blood pressure , and heart rate of the volunteers were evaluated .


For statistical analysis , the Wilcoxon signed rank test and 2-way repeated measures analysis of variation were used .


The CPT was increased with the 2 solutions and peaked 10 minutes after injection .


CPT values 10 and 20 minutes after injection of lidocaine plus dexmedetomidine solution were considerably higher than those with lidocaine solution .


The duration of an important increase in the CPT after injection with lidocaine plus dexmedetomidine solution was longer than that with lidocaine .


Furthermore , the area under the time curve of CPT was considerably higher with lidocaine plus dexmedetomidine solution than with lidocaine solution .


No volunteer showed a change in sedation level , blood pressure , or heart rate after injection with either test solution throughout the experiment .


The present study showed that a combination of dexmedetomidine plus lidocaine considerably enhances the local anesthetic potency of lidocaine without any major influences on the cardiovascular system when locally injected into the oral mucosa .


The purpose of this study was to determine the efficacy of a clinician referral and exercise program in improving exercise levels and quality of life for men with prostate cancer .


This was a multicenter cluster randomized controlled trial in Melbourne , Australia comprising 15 clinicians : 8 clinicians were randomized to refer eligible participants ( n = 54 ) to a 12-week exercise program comprising 2 supervised gym sessions and 1 home-based session per week , and 7 clinicians were randomized to follow usual care ( n = 93 ) .


The primary outcome was self-reported physical activity ; the secondary outcomes were quality of life , anxiety , and symptoms of depression .


A significant intervention effect was observed for vigorous-intensity exercise ( effect size : Cohen 's d , 0.46 ; 95 % confidence interval [ CI ] , 0.09-0 .82 ; P = .010 ) but not for combined moderate and vigorous exercise levels ( effect size : d , 0.08 ; 95 % CI , -0.28 to 0.45 ; P = .48 ) .


Significant intervention effects were also observed for meeting exercise guidelines ( 150 min/wk ; odds ratio , 3.9 ; 95 % CI , 1.9-7 .8 ; P = .002 ) ; positive intervention effects were observed in the intervention group for cognitive functioning ( effect size : d , 0.34 ; 95 % CI , -0.02 to 0.70 ; P = .06 ) and depression symptoms ( effect size : d , -0.35 ; 95 % CI , -0.71 to 0.02 ; P = .06 ) .


Eighty percent of participants reported that the clinician 's referral influenced their decision to participate in the exercise program .


The clinician referral and 12-week exercise program significantly improved vigorous exercise levels and had a positive impact on mental health outcomes for men living with prostate cancer .


Further research is needed to determine the sustainability of the exercise program and its generalizability to other cancer populations .


To compare the effectiveness and safety of the hemoglobin-based nitric oxide scavenger , pyridoxalated hemoglobin polyoxyethylene , against placebo in patients with vasopressor-dependent distributive shock .


Multicenter , randomized , placebo-controlled , open-label study .


Sixty-one participating ICUs in six European countries ( Austria , Belgium , Germany , the Netherlands , Spain , and United Kingdom ) .


All patients admitted with distributive shock , defined as the presence of at least two systemic inflammatory response syndrome criteria , persisting norepinephrine dependence and evidence of organ dysfunction/hypoperfusion despite adequate fluid resuscitation .


Patients were randomized to receive 0.25 mL/kg/hr pyridoxalated hemoglobin polyoxyethylene ( 20 mg Hb/kg/hr ) or an equal volume of placebo , infused for up to 150 hours , in addition to conventional vasopressor therapy .


The study was stopped after interim analysis showed higher mortality in the pyridoxalated hemoglobin polyoxyethylene group and an increased prevalence of adverse events .


At this time , 377 patients had been randomized to pyridoxalated hemoglobin polyoxyethylene ( n = 183 ) or placebo ( n = 194 ) .


Age , gender , type of patient ( medical/surgical ) , and Acute Physiology and Chronic Health Evaluation II scores were similar between groups .


Twenty-eight-day mortality rate was 44.3 % in the pyridoxalated hemoglobin polyoxyethylene group versus 37.6 % in the placebo group ( OR , 1.29 ; 95 % CI , 0.85-1 .95 ; p = 0.227 ) .


In patients with higher organ dysfunction scores ( Sepsis-related Organ Failure Assessment > 13 ) , mortality rates were significantly higher in the pyridoxalated hemoglobin polyoxyethylene group when compared with those in placebo-treated patients ( 60.9 % vs 39.2 % ; p = 0.014 ) .


Survivors who received pyridoxalated hemoglobin polyoxyethylene had a longer vasopressor-free time ( 21.3 vs 19.7 d ; p = 0.035 ) .


In this randomized , controlled phase III trial in patients with vasopressor-dependent distributive shock , administration of a pyridoxalated hemoglobin solution decreased the need for vasopressors but was associated with a trend to increased mortality .


Few Iranian women take the Papanicolaou test despite its important role in preventing cervical cancer .


This study aimed to determine the effectiveness of an educational intervention based on the protection motivation theory ( PMT ) variables and implementation intentions in the first and second Pap test practice among Iranian women .


In this quasi-randomized controlled trial , 200 women who were referred to 30 primary health care clinics in Tehran were randomly selected .


PMT variables and Pap test practice were measured at baseline and again after 3 and 15 months .


The 4-week educational intervention program was conducted for the intervention group .


Following the intervention , the mean scores of self-efficacy , perceived vulnerability , and behavior intention variables were significantly higher in the intervention group when compared to the control group ( p < 0.05 ) .


No significant differences were found in the perceived severity , response efficacy , response cost , and fear between the two groups following the intervention .


Higher percent of women in the intervention group had obtained first and second Pap test compared to the controls .


The PMT and implementation intentions provide a suitable theory-based framework for developing educational interventions regarding Pap test practice in Iran .


Pelvic floor muscle training ( PFMT ) has level 1 evidence of reducing the size and symptoms associated with pelvic organ prolapse ( POP ) .


There is scant knowledge , however , regarding whether PFMT has an effect on sexual function .


The aim of the trial was to evaluate the effect of PFMT on sexual function in women with POP .


In this randomized controlled trial , 50 women were randomized to an intervention group ( 6 months of PFMT and lifestyle advice ) and 59 women were randomized to a control group ( lifestyle advice only ) .


Participants completed a validated POP-specific questionnaire to describe frequency and bother of prolapse , bladder , bowel , and sexual symptoms and answered a semi-structured interview .


No significant change in number of women being sexually active was reported .


There were no significant differences between groups regarding change in satisfaction with frequency of intercourse .


Interview data revealed that 19 ( 39 % ) of women in the PFMT group experienced improved sexual function vs. two ( 5 % ) in the control group ( P < 0.01 ) .


Specific improvements reported by some of the women were increased control , strength and awareness of the pelvic floor , improved self-confidence , sensation of a `` tighter '' vagina , improved libido and orgasms , resolution of pain with intercourse , and heightened sexual gratification for partners .


Women who described improved sexual function demonstrated the greatest increases in pelvic floor muscle ( PFM ) strength ( mean 16 10 cmH2 0 ) and endurance ( mean 150 140 cmH2 0s ) ( P < 0.01 ) .


PFMT can improve sexual function in some women .


Women reporting improvement in sexual function demonstrated the greatest increase in PFM strength and endurance .


Service user satisfaction with therapy is a key part of the therapeutic process .


The aim of this study was to investigate service user experiences of an 11-week group positive psychology intervention for psychosis ( WELLFOCUS PPT ) in the context of a randomized controlled trial ( ISRCTN04199273 ) .


Participants were 37 individuals ( 51 % male ; mean age 45.6 years ) receiving the intervention as part of the trial .


Semistructured interviews and focus groups were conducted to investigate participants ' views of WELLFOCUS PPT .


Transcripts were analyzed both deductively and inductively to identify common themes .


Feedback about the group experience was positive throughout .


Components found helpful included learning to savor experiences , identifying and developing strengths , forgiveness , gratitude , and therapist self-disclosure .


Findings emphasize the importance of considering service users ' perceptions of therapy and can be used to guide clinicians in deciding whether to include one or more of the components of WELLFOCUS PPT in therapy .


To determine the effectiveness of a single perioperative prophylactic 2g dose of cephalexin in preventing surgical site infection ( SSI ) following excision of skin lesions from the lower limb .


Prospective double-blinded placebo-controlled trial testing for difference in infection rates .


Primary care in regional North Queensland , Australia .


52 patients undergoing lower limb skin lesion excision .


2g dose of cephalexin 30-60min before excision .


Incidence of SSI .


Incidence of SSI was 12.5 % ( 95 % CI 2.7 % to 32.4 % ) in the cephalexin group compared with 35.7 % ( 95 % CI 18.6 % to 55.9 % ) in the placebo group ( p = 0.064 ) .


This represented an absolute reduction of 23.21 % ( 95 % CI -0.39 % to 46.82 % ) , relative reduction of 65.00 % ( 95 % CI -12.70 % to 89.13 % ) and number-needed-to-treat of 4.3 .


Administration of a single 2g dose of cephalexin 30-60min before skin lesion excision from the lower limb may produce a reduction in the incidence of infection ; however , this study was underpowered to statistically determine this .


ACTRN12611000595910 .


Multicentric Castleman 's disease is a rare lymphoproliferative disorder driven by dysregulated production of interleukin 6 .


No randomised trials have been done to establish the best treatment for the disease .


We assessed the safety and efficacy of siltuximab-a chimeric monoclonal antibody against interleukin 6-in HIV-negative patients with multicentric Castleman 's disease .


We did this randomised , double-blind , placebo-controlled study at 38 hospitals in 19 countries worldwide .


We enrolled HIV-negative and human herpesvirus-8-seronegative patients with symptomatic multicentric Castleman 's disease .


Treatment allocation was randomised with a computer-generated list , with block size six , and stratification by baseline corticosteroid use .


Patients and investigators were masked to treatment allocation .


Patients were randomly assigned ( 2:1 ) to siltuximab ( 11 mg/kg intravenous infusion every 3 weeks ) or placebo ; all patients also received best supportive care .


Patients continued treatment until treatment failure .


The primary endpoint was durable tumour and symptomatic response for at least 18 weeks for the intention-to-treat population .


Enrolment has been completed .


The study is registered with ClinicalTrials.gov , number NCT01024036 .


We screened 140 patients , 79 of whom were randomly assigned to siltuximab ( n = 53 ) or placebo ( n = 26 ) .


Durable tumour and symptomatic responses occurred in 18 ( 34 % ) of 53 patients in the siltuximab group and none of 26 in the placebo group ( difference 340 % , 95 % CI 111-548 , p = 00012 ) .


The incidence of grade 3 or more adverse events ( 25 [ 47 % ] vs 14 [ 54 % ] ) and serious adverse events ( 12 [ 23 % ] vs five [ 19 % ] ) was similar in each group despite longer median treatment duration with siltuximab than with placebo ( 375 days [ range 1-1031 ] vs 152 days [ 23-666 ] ) .


The most common grade 3 or higher were fatigue ( five vs one ) , night sweats ( four vs one ) , and anaemia ( one vs three ) .


Three ( 6 % ) of 53 patients had serious adverse events judged reasonably related to siltuximab ( lower respiratory tract infection , anaphylactic reaction , sepsis ) .


Siltuximab plus best supportive care was superior to best supportive care alone for patients with symptomatic multicentric Castleman 's disease and well tolerated with prolonged exposure .


Siltuximab is an important new treatment option for this disease .


Janssen Research & Development .


This article evaluates the effectiveness of two interventions : a self-leveling pallet carousel designed to position the loads vertically and horizontally at origin , and an adjustable cart designed to raise loads vertically at destination to reduce spine loads .


Low back disorders among workers in manual material handling industries are very prevalent and have been linked to manual palletizing operations .


Evidence into the effectiveness of ergonomic interventions is limited , with no research that investigates interventions with adjustable load location .


Thirteen males experienced in manual material handling participated in simulated order selecting tasks where spine loads were quantified for each intervention condition : carousel to traditional cart , pallet to traditional cart , pallet to adjustable cart , and carousel to adjustable cart .


The results showed that combining both devices results in reduction in spine compression ( 61 % ) , anterior-posterior shear ( 72 % ) , and lateral shear ( 63 % ) compared to traditional palletizing conditions .


Individually , the carousel was responsible for the greatest reductions , but the lowest values were typically achieved by combining the adjustable cart and carousel .


The combination of the interventions ( self-leveling carousel and adjustable cart ) was most effective in reducing the spine loads when compared to the traditional pallet-cart condition .


The individual interventions also reduced the loads compared to the traditional condition .


With de-palletizing/palletizing tasks being a major source of low back injuries , the combination of self-leveling carousel and adjustable cart has been found to be effective in reducing the peak spine loading as compared to traditional pallet on floor and nonadjustable flat cart conditions .


To determine the influence of omega-3 supplementation on vitreous vascular endothelial growth factor A ( VEGF-A ) levels in patients with exudative age-related macular degeneration ( wet AMD ) receiving intravitreal anti-VEGF treatment .


Prospective , randomized , open-label , single-center , clinical trial , consecutive interventional case series .


The study included 3 cohorts with wet AMD and a control group with epiretinal membrane or macular hole .


Twenty wet AMD patients being treated with anti-VEGF were randomized to daily supplementation of antioxidants , zinc , and carotenoids with omega-3 fatty acids ( docosahexaenoic acid and eicosapentaenoic acid ; group 1 , n = 10 ) or without omega-3 fatty acids ( group 2 , n = 10 ) .


They were compared with an anti-VEGF treatment-nave wet AMD group ( group 3 , n = 10 ) and an epiretinal membrane or macular hole group ( group 4 , n = 10 ) .


Primary outcome was vitreal VEGF-A levels ( at the time of anti-VEGF injection ) .


Secondary outcomes were plasma VEGF-A and central foveal thickness .


Patients with new submacular hemorrhage or any other treatment within 3 months were excluded .


Final analyses included 9 , 6 , 7 , and 8 patients in groups 1 through 4 , respectively .


Patients receiving omega-3s ( group 1 ) had significantly lower levels of vitreal VEGF-A ( 141.11 61.89 pg/mL ) when compared with group 2 ( 626.09 279.27 pg/mL ; P = .036 ) and group 3 ( 735.48 216.43 pg/mL ; P = .013 ) , but similar levels to group 4 ( 235.81 33.99 pg/mL ; P = .215 ) .


All groups showed similar values for plasma VEGF-A and central foveal thickness measurements .


This study demonstrated that omega-3 supplementation combined with anti-VEGF treatment is associated with decreased vitreal VEGF-A levels in wet AMD patients .


Exercise at 50-60 % of peak oxygen consumption ( VO2 peak ) stimulates maximal fat oxidation rates .


Despite a lower estimated work performed ; high-intensity intermittent exercise ( HIIE ) training produces greater fat mass reductions when compared with workload-matched continuous ( CON ) steady state exercise .


No metabolic basis has been documented nor mechanisms offered to explain this anomaly .


This study investigated the physiological and metabolic responses of two different workload-matched exercise protocols .


On separate occasions and at least 1week apart , eight apparently healthy males cycled for 30min at either 50 % VO2 peak ( CON ) or performed repeated 20s bouts of supramaximal exercise at 150 % VO2 peak separated by 40s rest ( HIIE ) .


The average heart rate , oxygen consumption , plasma glycerol and free fatty acid concentrations were not different during exercise and recovery between the trials .


Plasma lactate and hypoxanthine ( Hx ) concentrations were elevated and urinary excretion rates of Hx and uric acid were greater following HIIE as compared to CON ( P < 0.05 ) .


Exercise-induced plasma Hx accumulation and urinary purine excretion are greater following HIIE and indirectly represents a net loss of adenosine triphosphate ( ATP ) from the muscle .


The subsequent restorative processes required for intramuscular de novo replacement of ATP may contribute to a negative energy balance and in part , account for the potential accelerated fat loss observed with HIIE when compared with CON training programs .


Single blinded , randomized clinical trial for the evaluation of lumbosacral orthoses ( LSOs ) in the management of lower back pain ( LBP ) .


To evaluate the effects of two types of LSOs on self-rated disability in patients with LBP .


LSOs are commonly used for the management of LBP , but their effectiveness may vary because of design .


An inextensible LSO ( iLSO ) reduces trunk motion and increases trunk stiffness , whereas an extensible LSO ( eLSO ) does not .


A total of 98 participants with LBP were randomized to 3 groups : ( 1 ) standard care ( SC ) group , which included medication and physical therapy ( n = 29 ) , ( 2 ) SC with eLSO ( eLSO group ) ( n = 32 ) , and ( 3 ) SC with iLSO ( iLSO group ) ( n = 37 ) .


Outcome measures were evaluated before and after 2 weeks of treatment : modified Oswestry Disability Index ( ODI ) , Patient Specific Activity Scale , pain ratings , and Fear Avoidance Beliefs Questionnaire .


There were no statistically significant differences between groups at baseline .


Compared with the SC alone , iLSO group showed greater improvement on the ODI scores ( P = 0.01 ) but not the eLSO group .


The ODI scores improved by a mean of 2.4 ( 95 % confidence interval [ CI ] , 2.2-7 .1 ) , 8.1 ( 95 % CI , 2.8-13 .4 ) , and 14.0 ( 95 % CI , 8.2-19 .8 ) points for SC , eLSO , and iLSO groups , respectively .


Individuals wearing the iLSO had 4.7 times higher odds of achieving 50 % or greater improvement in the ODI scores than those assigned to SC ( 95 % CI , 1.2-18 .5 , P = 0.03 ) .


Both the eLSO and iLSO groups had a greater improvement in the Patient Specific Activity Scale scores than the SC group ( P = .05 and P = 0.01 , respectively ) , but the change did not meet the minimal clinically important difference .


Pain ratings improved for all 3 groups , with no statistical difference between them .


Finally , no significant differences across groups were found for the Fear Avoidance Beliefs Questionnaire .


An iLSO led to greater improvement in ODI scores than SC and an eLSO .


We surmise that the likely mechanism responsible for this difference in outcome was the added trunk stiffness and motion restriction by the iLSO .


2 .


Ixekizumab is a humanised monoclonal antibody against the proinflammatory cytokine interleukin 17A .


We report two studies of ixekizumab compared with placebo or etanercept to assess the safety and efficacy of specifically targeting interleukin 17A in patients with widespread moderate-to-severe psoriasis .


In two prospective , double-blind , multicentre , phase 3 studies ( UNCOVER-2 and UNCOVER-3 ) , eligible patients were aged 18 years or older , had a confirmed diagnosis of chronic plaque psoriasis at least 6 months before baseline ( randomisation ) , 10 % or greater body-surface area involvement at both screening and baseline visits , at least a moderate clinical severity as measured by a static physician global assessment ( sPGA ) score of 3 or more , and a psoriasis area and severity index ( PASI ) score of 12 .


Participants were randomly assigned ( 1:2:2:2 ) by computer-generated random sequence with an interactive voice response system to receive subcutaneous placebo , etanercept ( 50 mg twice weekly ) , or one injection of 80 mg ixekizumab every 2 weeks , or every 4 weeks after a 160 mg starting dose .


Blinding was maintained with a double-dummy design .


Coprimary efficacy endpoints were proportions of patients achieving sPGA score 0 or 1 and 75 % or greater improvement in PASI at week 12 .


Analysis was by intention to treat .


These trials are registered with ClinicalTrials.gov , numbers NCT01597245 and NCT01646177 .


Between May 30 , 2012 , and Dec 30 , 2013 , 1224 patients in UNCOVER-2 were randomly assigned to receive subcutaneous placebo ( n = 168 ) , etanercept ( n = 358 ) , or ixekizumab every 2 weeks ( n = 351 ) or every 4 weeks ( n = 347 ) ; between Aug 11 , 2012 , and Feb 27 , 2014 , 1346 patients in UNCOVER-3 were randomly assigned to receive placebo ( n = 193 ) , etanercept ( n = 382 ) , ixekizumab every 2 weeks ( n = 385 ) , or ixekizumab every 4 weeks ( n = 386 ) .


At week 12 , both primary endpoints were met in both studies .


For UNCOVER-2 and UNCOVER-3 respectively , in the ixekizumab every 2 weeks group , PASI 75 was achieved by 315 ( response rate 897 % ; [ effect size 874 % ( 975 % CI 829-918 ) vs placebo ; 481 % ( 412-550 ) vs etanercept ] ) and 336 ( 873 % ; [ 800 % ( 744-857 ) vs placebo ; 339 % ( 270-407 ) vs etanercept ] ) patients ; in the ixekizumab every 4 weeks group , by 269 ( 775 % ; [ 751 % ( 695-808 ) vs placebo ; 359 % ( 282-436 ) vs etanercept ] ) and 325 ( 842 % ; [ 769 % ( 710-828 ) vs placebo ; 308 % ( 237-379 ) vs etanercept ] ) patients ; in the placebo group , by four ( 24 % ) and 14 ( 73 % ) patients ; and in the etanercept group by 149 ( 416 % ) and 204 ( 534 % ) patients ( all p < 00001 vs placebo or etanercept ) .


In the ixekizumab every 2 weeks group , sPGA 0/1 was achieved by 292 ( response rate 832 % ; [ effect size 808 % ( 975 % CI 756-860 ) vs placebo ; 472 % ( 399-544 ) vs etanercept ] ) and 310 ( 805 % ; [ 738 % ( 677-799 ) vs placebo ; 389 % ( 317-461 ) vs etanercept ] ) patients ; in the ixekizumab every 4 weeks group by 253 ( 729 % ; [ 705 % ( 646-765 ) vs placebo ; 369 % ( 291-447 ) vs etanercept ] ) and 291 ( 754 % ; [ 687 % ( 623-750 ) vs placebo ; 338 % ( 263-413 ) vs etanercept ] ) patients ; in the placebo group by four ( 24 % ) and 13 ( 67 % ) patients ; and in the etanercept group by 129 ( 360 % ) and 159 ( 416 % ) patients ( all p < 00001 vs placebo or etanercept ) .


In combined studies , serious adverse events were reported in 14 ( 19 % ) of 734 patients given ixekizumab every 2 weeks , 14 ( 19 % ) of 729 given ixekizumab every 4 weeks , seven ( 19 % ) of 360 given placebo , and 14 ( 19 % ) of 739 given etanercept ; no deaths were noted .


Both ixekizumab dose regimens had greater efficacy than placebo and etanercept over 12 weeks in two independent studies .


These studies show that selectively neutralising interleukin 17A with a high affinity antibody potentially gives patients with psoriasis a new and effective biological therapy option .


Eli Lilly and Co. .


Provoked vestibulodynia ( PVD ) , a frequent form of chronic genital pain , is associated with decreased sexual function for afflicted women , as well as impoverished sexual satisfaction for women and their partners .


Pain and sexuality outcomes for couples with PVD are influenced by interpersonal factors , such as pain catastrophizing , partner responses to pain , ambivalence over emotional expression , attachment style and perceived relationship and sexual intimacy .


Despite recommendations in the literature to include the partner in cognitive-behavioral therapy targeted at improving pain and sexuality outcomes , no randomized clinical trial has tested the efficacy of this type of intervention and compared it to a first-line medical intervention .


This bi-center , randomized clinical trial is designed to examine the efficacy of cognitive-behavioral couple therapy compared to topical lidocaine .


It is conducted across two Canadian university-hospital centers .


Eligible women diagnosed with PVD and their partners are randomized to one of the two interventions .


Evaluations are conducted using structured interviews and validated self-report measures at three time points : Pre-treatment ( T1 : prior to randomization ) , post-treatment ( T2 ) , and 6-month follow-up ( T3 ) .


The primary outcome is the change in reported pain during intercourse between T1 and T2 .


Secondary outcomes focus on whether there are significant differences between the two treatments at T2 and T3 on ( a ) the multidimensional aspects of women 's pain and ( b ) women and partners ' sexuality ( sexual function and satisfaction ) , psychological adjustment ( anxiety , depression , catastrophizing , self-efficacy , and quality of life ) , relationship factors ( partner responses and dyadic adjustment ) and self-reported improvement and treatment satisfaction .


In order to detect an effect size as small as 0.32 for secondary outcomes , a sample of 170 couples is being recruited ( 27 % dropout expected ) .


A clinically significant decrease in pain is defined as a 30 % reduction .


The randomized clinical trial design is the most appropriate to examine the efficacy of cognitive-behavioral couple therapy , a recently developed and pilot-tested psychosocial intervention for couples coping with PVD , in comparison to a frequent first-line treatment option , topical lidocaine .


Findings from this study will provide important information about empirically supported treatment options for PVD , and inform future treatment development and research for this patient population .


Clinicaltrials.gov NCT01935063 ; registration date : 27 August 27 2013 .


At 42.5 months of median follow-up , PHARE failed to show that 6 was non-inferior to 12 months of adjuvant trastuzumab .


From the results of PHARE , questions remain regarding whether the magnitude of benefit derived from 1 year is sufficient to justify its systematic use for different patient subgroups .


Treatment effects were evaluated according to various tumour characteristics , and the multivariate Cox proportional hazards regression models were carried out on metastases-free survival ( MFS ) in the 12 months control arm .


A prognostic score was defined providing the identification of patient categories with similar risks .


The 6-month arm was used as a validation set in order to test for heterogeneity .


This study is registered at clinicaltrials.gov , number NCT00381901 .


A total of 261 metastatic events were observed and four prognostic groups were defined : very low , low , intermediate and high risk in the 12-month arm .


The corresponding 3-year MFS rates were 98.3 % , 95.8 % , 90.4 % and 78.4 % in the four prognostic groups , respectively .


In the 6-month arm , the 3-year MFS rates were 98.3 % , 94.2 % , 85.7 % and 74.8 % in the four prognostic groups , respectively .


In the very low-risk group , the potential absolute benefit of standard duration of trastuzumab was small enough to indicate that optimal standard treatment might be clinically questionable .


On the other hand , the 3-year metastasis occurrence rates strongly support the need for a search of a more efficient treatment in the low - , intermediate - and high-risk groups .


To compare the outcomes of shock wave lithotripsy ( SWL ) combined with inclined position and SWL alone in patients with lower pole calyx stones .


Seven hundred forty patients who underwent SWL treatment for lower pole renal stones with a total diameter of 2 cm or less were prospectively randomized into two groups .


They were comparable in terms of age , sex , and stone diameters .


Patients with lower calyceal stones ( 4-20 mm ) were randomized to SWL ( 368 patients ) or SWL with simultaneous inclination ( 372 patients ) with 30o head down Trendelenburg position ) .


Shock wave and session numbers were standardized according to stone size .


Additional standardized shock waves were given to patients with stone fragments determined by kidney urinary bladder film and ultrasound at weeks 1 , 4 , 10 .


The overall stone free rate ( SFR ) was 73 % ( 268/368 ) in patients with SWL alone and 81 % ( 300/372 ) in SWL with inclination at the end of 12th week ( p = 0.015 ) .


No significant adverse events were noted in both treatment groups .


Simultaneous inclination of patients during SWL session increase SFR in lower caliceal stones significantly compared to SWL treatment alone .


To study the effects of zinc and steroid in the treatment of traumatic anosmia .


A prospective , randomized study .


Academic medical center .


Patients with a clear history of loss of smell after head injury and whose thresholds were -1 measured by the phenyl ethyl alcohol threshold test were included in this study from January 2010 to May 2013 .


They were randomly divided into 4 groups .


Patients in group 1 were treated with zinc gluconate for a month and high-dose prednisolone with tapering for 2 weeks .


Those in group 2 took only zinc gluconate , and those in group 3 took only prednisolone .


Patients in group 4 did not take any medicine .


All patients were followed up by phenyl ethyl alcohol threshold testing , and magnetic resonance imaging was performed to measure the volume of olfactory bulbs .


Thirty-nine patients in group 1 , 35 in group 2 , 34 in group 3 , and 37 in group 4 completed the study .


The recovery of olfactory function was observed in 11 patients ( 28.2 % ) in group 1 , in 9 ( 25.7 % ) in group 2 , in 4 ( 11.8 % ) in group 3 , and in 1 ( 2.7 % ) in group 4 .


The recovery rates of olfactory function of groups 1 and 2 were significantly higher than the recovery rate of group 4 .


The volume of olfactory bulbs was not significantly different between those with and without improved olfactory function .


Our results show that zinc gluconate has a promising effect in treating traumatic anosmia .


Diabetes mellitus is an increasingly prevalent metabolic disorder that is associated with substantial disease burden .


Australia has an opportunity to improve ways of caring for the growing number of people with diabetes , but this may require changes to the way care is funded , organised and delivered .


To inform how best to care for people with diabetes , and to identify the extent of change that is required to achieve this , the Diabetes Care Project ( DCP ) will evaluate the impact of two different , evidence-based models of care ( compared to usual care ) on clinical quality , patient and provider experience , and cost .


The DCP uses a pragmatic , cluster randomised controlled trial design .


Accredited general practices that are situated within any of the seven Australian Medicare Locals/Divisions of General Practice that have agreed to take part in the study were invited to participate .


Consenting practices will be randomly assigned to one of three treatment groups for approximately 18 to 22 months : ( a ) control group ( usual care ) ; ( b ) Intervention 1 ( which tests improvements that could be made within the current funding model , facilitated through the use of an online chronic disease management network ) ; or ( c ) Intervention 2 ( which includes the same components as Intervention 1 , as well as altered funding to support voluntary patient registration with their practice , incentive payments and a care facilitator ) .


Adult patients who attend the enrolled practices and have established ( 12 month 's duration ) type 1 diabetes mellitus or newly diagnosed or established type 2 diabetes mellitus are invited to participate .


Multiple outcomes will be studied , including changes in glycosylated haemoglobin ( primary outcome ) , changes in other biochemical and clinical metrics , incidence of diabetes-related complications , quality of life , clinical depression , success of tailored care , patient and practitioner satisfaction , and budget sustainability .


This project responds to a need for robust evidence of the clinical and economic effectiveness of coordinated care for the management of diabetes in the Australian primary care setting .


The outcomes of the study will have implications not only for diabetes management , but also for the management of other chronic diseases , both in Australia and overseas .


Australian New Zealand Clinical Trials Registry ( ACTRN12612000363886 ) ; World Health Organisation ( U1111-1128-0481 ) .


To investigate and compare the effects of superelastic nickel-titanium and multistranded stainless steel archwires on pain during the initial phase of orthodontic treatment .


A double-blind two-arm parallel design stratified randomized clinical trial .


A single centre in India between December 2010 and June 2012 .


A total of 96 participants ( 48 male and 48 females ; 14.12.1 years old ) were randomized ( stratified on age , sex and initial crowding ) to superelastic nickel-titanium or multistranded stainless steel archwire groups using a computer-generated allocation sequence .


We compared 0.016-inch superelastic nickel-titanium and 0.0175-inch multistranded stainless steel wires in 0.022-inch slot ( Roth prescription ) preadjusted edgewise appliances .


The follow-up period was 14 days .


Outcome was assessed with a visual analogue scale at baseline and 32 pre-specified follow-up points .


Data was analyzed using mixed-effects model analysis .


One participant was lost to follow up and 10 were excluded from the analysis due to bond failure or incomplete questionnaire answers .


Ultimately , 85 participants ( 42 males and 43 females ; 14.12.0 years old ) were analysed for the final results .


No statistically significant difference was found for overall pain [ F value = 2.65 , degrees of freedom ( df ) = 92.6 ; P = 0.1071 ] .


However , compared to multistranded stainless steel wires , pain in subjects with superelastic nickel-titanium archwires was significantly greater at 12 h ( t = 2.34 ; P = 0.0193 ) , as well as at day 1 in the morning ( t = 2.21 , P = 0.0273 ) , afternoon ( t = 2.11 , P = 0.0346 ) and at bedtime ( t = 2.03 , P = 0.042 ) .


For overall pain , there was no statistically significant difference between the two wires .


However , subjects with superelastic nickel-titanium archwires had a significantly higher pain at peak level .


Neurodevelopmental theories of psychosis highlight the potential benefits of early intervention , prevention , and/or preemption .


How early intervention should take place has not been established , nor whether interventions based on social learning principles can have preemptive effects .


The objective was to test whether a comprehensive psychosocial intervention can significantly alter psychotic symptom trajectories during adolescence-a period of heightened risk for a wide range of psychopathology .


This study was a randomized controlled trial ( RCT ) of Multidimensional Treatment Foster Care ( MTFC ) for delinquent adolescent girls .


Assessment of psychotic symptoms took place at baseline and then 6 , 12 , 18 , and 24 months post-baseline using a standardized self-report instrument ( Brief Symptom Inventory ) .


A second source of information about psychotic symptoms was obtained at baseline or 12 months , and again at 24 months using a structured diagnostic interview ( the Diagnostic Interview Schedule for Children [ DISC ] ) .


Significant benefits for MTFC over treatment as usual for psychosis symptoms were observed over a 24-month period .


Findings were replicated across both measures .


Effects were independent of substance use and initial symptom severity and persisted beyond the initial intervention period .


Ameliorating nonclinical psychotic symptoms trajectories beginning in mid-adolescence via a multifaceted psychosocial intervention is possible .


Developmental research on nonclinical psychotic symptoms and their prognostic value should be complemented by more psychosocial intervention research aimed at modifying these symptom trajectories early in their natural history .


Clinical trial registration information-Juvenile Justice Girls Randomized Control Trial : Young Adult Follow-up ; http://clinicaltrials.gov; NCT01341626 .


INT131 besylate is a potent , nonthiazolidinedione , selective peroxisome proliferator-activated receptor ( PPAR ) modulator ( SPPARM ) designed to improve glucose metabolism while minimizing the side effects of full PPAR agonists .


This placebo-controlled study compared the efficacy and side effects of INT131 besylate versus 45 mg pioglitazone HCl in subjects with type 2 diabetes ( T2D ) .


This was a 24-week randomized , double-blind , placebo - and active-controlled study of 0.5-3 .0 mg INT131 versus 45 mg pioglitazone or placebo daily in 367 subjects with T2D on sulfonylurea or sulfonylurea plus metformin .


The primary efficacy analysis was the comparison of change from baseline to week 24 in hemoglobin A1c ( HbA1c ) across treatment groups .


Fluid status was assessed with a prospective scoring system for lower-extremity pitting edema .


INT131 had a steep dose response for efficacy as measured by changes in HbA1c .


After 24 weeks ' treatment , the 0.5-mg dose demonstrated minimal efficacy ( HbA1c -0.3 0.12 % ) and the 2-mg dose demonstrated near-maximal efficacy ( HbA1c -1.1 0.12 % ) , which was not statistically different from the efficacy of 45 mg pioglitazone ( HbA1c -0.9 0.12 % ; P < 0.01 for noninferiority ) .


With the 1-mg dose , INT131 provided significant improvements in glycemic control ( HbA1c 0.8 0.12 ; P < 0.001 vs. placebo ) but with less edema , weight gain , and hemodilution than observed with 45 mg pioglitazone .


INT131 demonstrated dose-dependent reductions in HbA1c , equivalent to 45 mg pioglitazone , but with less fluid accumulation and weight gain , consistent with its SPPARM design .


HIV-1 vaccine development has advanced slowly due to viral antigenic diversity , poor immunogenicity and recently , safety concerns associated with human adenovirus serotype-5 vectors .


To tackle HIV-1 variation , we designed a unique T-cell immunogen HIVconsv from functionally conserved regions of the HIV-1 proteome , which were presented to the immune system using a heterologous prime-boost combination of plasmid DNA , a non-replicating simian ( chimpanzee ) adenovirus ChAdV-63 and a non-replicating poxvirus , modified vaccinia virus Ankara .


A block-randomized , single-blind , placebo-controlled phase I trial HIV-CORE 002 administered for the first time candidate HIV-1 - vaccines or placebo to 32 healthy HIV-1 / 2-uninfected adults in Oxford , UK and elicited high frequencies of HIV-1-specific T cells capable of inhibiting HIV-1 replication in vitro .


Here , detail safety and tolerability of these vaccines are reported .


Local and systemic reactogenicity data were collected using structured interviews and study-specific diary cards .


Data on all other adverse events were collected using open questions .


Serum neutralizing antibody titres to ChAdV-63 were determined before and after vaccination .


Two volunteers withdrew for vaccine-unrelated reasons .


No vaccine-related serious adverse events or reactions occurred during 190 person-months of follow-up .


Local and systemic events after vaccination occurred in 27/32 individuals and most were mild ( severity grade 1 ) and predominantly transient ( < 48 hours ) .


Myalgia and flu-like symptoms were more strongly associated with MVA than ChAdV63 or DNA vectors and more common in vaccine recipients than in placebo .


There were no intercurrent HIV-1 infections during follow-up .


2/24 volunteers had low ChAdV-63-neutralizing titres at baseline and 7 increased their titres to over 200 with a median ( range ) of 633 ( 231-1533 ) post-vaccination , which is of no safety concern .


These data demonstrate safety and good tolerability of the pSG2.HIVconsv DNA , ChAdV63.HIVconsv and MVA.HIVconsv vaccines and together with their high immunogenicity support their further development towards efficacy studies .


ClinicalTrials.gov NCT01151319 .


Low levels of health-enhancing physical activity require novel approaches that have the potential to reach broad populations .


Web-based interventions are a popular approach for behaviour change given their wide reach and accessibility .


However , challenges with participant engagement and retention reduce the long-term maintenance of behaviour change .


Web 2.0 features present a new and innovative online environment supporting greater interactivity , with the potential to increase engagement and retention .


In order to understand the applicability of these innovative interventions for the broader population , ` real-world ' interventions implemented under ` everyday conditions ' are required .


The aim of this study is to investigate the difference in physical activity behaviour between individuals using a traditional Web 1.0 website with those using a novel Web 2.0 website .


In this study we will aim to recruit 2894 participants .


Participants will be recruited from individuals who register with a pre-existing health promotion website that currently provides Web 1.0 features ( http://www.10000steps.org.au ) .


Eligible participants who provide informed consent will be randomly assigned to one of the two trial conditions : the pre-existing 10000 Steps website ( with Web 1.0 features ) or the newly developed WALK 2.0 website ( with Web 2.0 features ) .


Primary and secondary outcome measures will be assessed by self-report at baseline , 3months and 12months , and include : physical activity behaviour , height and weight , Internet self-efficacy , website usability , website usage and quality of life .


This study has received ethics approval from the University of Western Sydney Human Research Ethics Committee ( Reference Number H8767 ) and has been funded by the National Health and Medical Research Council ( Reference Number 589903 ) .


Study findings will be disseminated widely through peer-reviewed publications , academic conferences and local community-based presentations .


Australian New Zealand Clinical Trials Registry Number : ACTRN12611000253909 , WHO Universal Trial Number : U111-1119-1755 .


Research suggests that people with bipolar disorder may be highly motivated to attain dominance and may over-estimate their social power ( Johnson and Carver , 2012 ) .


This manic temperament may provide an adaptive advantage in the pursuit of dominance and leadership ( Akiskal and Akiskal , 1992 ) .


It was hypothesized that people at high risk for bipolar disorder , as defined by the Hypomanic Personality Scale ( HPS ) , would fail to assume a submissive role when it was appropriate to do so .


Participants ( 81 undergraduates ) completed an image description task with a confederate .


Participants were randomly assigned to interact with a confederate who assumed one of three nonverbal postures : dominant ( expanded ) , neutral , or submissive ( constricted ) .


Nonverbal dominance behavior was defined as the rate at which participants expanded their body span during the task .


Consistent with hypotheses , an ANOVA indicated an interaction of Mania risk x Dominance condition on body expansion .


Whereas participants with low mania risk ( HPS scores ) adapted complementary behavior in response to the confederate , participants with high mania risk demonstrated a consistently dominant ( expanded ) nonverbal posture .


A major limitation of this study is the use of an analog measure of mania risk in place of clinical diagnoses .


In this experiment , participants at high risk for mania maintained a dominant posture even when submissiveness would have been more appropriate .


It is argued that persistent dominance behavior may play an important role in the interpersonal interactions of individuals at risk for bipolar disorder .


Inadequate designs and conflicting results from previous studies prompted the US Food and Drug Administration to publish guidelines for the design of clinical trials evaluating the effects of orally inhaled and intranasal corticosteroids on the growth of children .


This study conformed to these guidelines to evaluate the effect of triamcinolone acetonide aqueous nasal spray ( TAA-AQ ) on the growth of children with perennial allergic rhinitis ( PAR ) .


This randomized , double-blind , placebo-controlled , parallel-group , multicenter study evaluated the effect of once-daily TAA-AQ ( 110 g ) on the growth velocity ( GV ) of children aged 3-9 years with PAR by using stadiometry at baseline ( 4-6 months ) , during treatment ( 12 months ) , and at follow-up ( 2 months ) .


Hypothalamus-pituitary-adrenal ( HPA ) axis function was assessed by measuring urinary cortisol levels .


Details of adverse events were recorded .


Of 1078 subjects screened , 299 were randomized , and 216 completed the study ( placebo , 107 ; TAA-AQ , 109 ) .


In the primary analysis ( modified intent-to-treat : placebo , 133 ; TAA-AQ , 134 ) , least-squares mean GV during treatment was lower in the TAA-AQ group ( 5.65 cm/year ) versus placebo ( 6.09 cm/year ) .


The difference ( -0.45 cm/year ; 95 % confidence interval : -0.78 to -0.11 ; P = .01 ) , although clinically nonsignificant , was evident within 2 months of treatment and stabilized thereafter .


At follow-up , the GV approached baseline ( 6.70 cm/year ) in the TAA-AQ group ( 6.59 cm/year ) and decreased slightly in the placebo group ( 5.89 cm/year vs 6.06 cm/year at baseline ) .


No HPA axis suppression was observed .


By using rigorous Food and Drug Administration-recommended design elements , this study detected a small , statistically significant effect of TAA-AQ on the GV of children with PAR .


Fasting is characterised by profound changes in energy metabolism including progressive loss of body proteins .


The underlying mechanisms are however unknown and we therefore determined the effects of a 72-hour-fast on human skeletal muscle protein metabolism and activation of mammalian target of rapamycin ( mTOR ) , a key regulator of cell growth .


Eight healthy male volunteers were studied twice : in the postabsorptive state and following 72 hours of fasting .


Regional muscle amino acid kinetics was measured in the forearm using amino acid tracers .


Signaling to protein synthesis and breakdown were assessed in skeletal muscle biopsies obtained during non-insulin and insulin stimulated conditions on both examination days .


Fasting significantly increased forearm net phenylalanine release and tended to decrease phenylalanine rate of disappearance .


mTOR phosphorylation was decreased by 50 % following fasting , together with reduced downstream phosphorylation of 4EBP1 , ULK1 and rpS6 .


In addition , the insulin stimulated increase in mTOR and rpS6 phosphorylation was significantly reduced after fasting indicating insulin resistance in this part of the signaling pathway .


Autophagy initiation is in part regulated by mTOR through ULK1 and fasting increased expression of the autophagic marker LC3B-II by 30 % .


p62 is degraded during autophagy but was increased by 10 % during fasting making interpretation of autophagic flux problematic .


MAFbx and MURF1 ubiquitin ligases remained unaltered after fasting indicating no change in protesomal protein degradation .


Our results show that during fasting increased net phenylalanine release in skeletal muscle is associated to reduced mTOR activation and concomitant decreased downstream signaling to cell growth .


To evaluate the efficacy of IV iron supplementation of anemic , critically ill trauma patients .


Multicenter , randomized , single-blind , placebo-controlled trial .


Four trauma ICUs .


Anemic ( hemoglobin < 12g/dL ) trauma patients enrolled within 72 hours of ICU admission and with an expected ICU length of stay of more than or equal to 5 days .


Randomization to iron sucrose 100mg IV or placebo thrice weekly for up to 2 weeks .


A total of 150 patients were enrolled .


Baseline iron markers were consistent with functional iron deficiency : 134 patients ( 89.3 % ) were hypoferremic , 51 ( 34.0 % ) were hyperferritinemic , and 64 ( 42.7 % ) demonstrated iron-deficient erythropoiesis as evidenced by an elevated erythrocyte zinc protoporphyrin concentration .


The median baseline transferrin saturation was 8 % ( range , 2-58 % ) .


In the subgroup of patients who received all six doses of study drug ( n = 57 ) , the serum ferritin concentration increased significantly for the iron as compared with placebo group on both day 7 ( 808.0 ng/mL vs 457.0 ng/mL , respectively , p < 0.01 ) and day 14 ( 1,046.0 ng/mL vs 551.5 ng/mL , respectively , p < 0.01 ) .


There was no significant difference between groups in transferrin saturation , erythrocyte zinc protoporphyrin concentration , hemoglobin concentration , or packed RBC transfusion requirement .


There was no significant difference between groups in the risk of infection , length of stay , or mortality .


Iron supplementation increased the serum ferritin concentration significantly , but it had no discernible effect on transferrin saturation , iron-deficient erythropoiesis , hemoglobin concentration , or packed RBC transfusion requirement .


Based on these data , routine IV iron supplementation of anemic , critically ill trauma patients can not be recommended ( NCT 01180894 ) .


Allogeneic mesenchymal precursor cells ( MPCs ) injected during left ventricular assist device ( LVAD ) implantation may contribute to myocardial recovery .


This trial explores the safety and efficacy of this strategy .


In this multicenter , double-blind , sham-procedure controlled trial , 30 patients were randomized ( 2:1 ) to intramyocardial injection of 25 million MPCs or medium during LVAD implantation .


The primary safety end point was incidence of infectious myocarditis , myocardial rupture , neoplasm , hypersensitivity reaction , and immune sensitization ( 90 days after randomization ) .


Key efficacy end points were functional status and ventricular function while temporarily weaned from LVAD support ( 90 days after randomization ) .


Patients were followed up until transplant or 12 months after randomization , whichever came first .


Mean age was 57.4 ( 13.6 ) years , mean left ventricular ejection fraction was 18.1 % , and 66.7 % were destination therapy LVADs .


No safety events were observed .


Successful temporary LVAD weaning was achieved in 50 % of MPC and 20 % of control patients at 90 days ( P = 0.24 ) ; the posterior probability that MPCs increased the likelihood of successful weaning was 93 % .


At 90 days , 3 deaths ( 30 % ) occurred in control patients , and none occurred in MPC patients .


Mean left ventricular ejection fraction after successful wean was 24.0 % ( MPC = 10 ) and 22.5 % ( control = 2 ; P = 0.56 ) .


At 12 months , 30 % of MPC patients and 40 % of control patients were successfully temporarily weaned from LVAD support ( P = 0.69 ) , and 6 deaths ( 30 % ) occurred in MPC patients .


Donor-specific HLA sensitization developed in 2 MPC and 3 control patients and resolved by 12 months .


In this preliminary trial , administration of MPCs appeared to be safe , and there was a potential signal of efficacy .


Future studies will evaluate the potential for higher or additional doses to enhance the ability to wean LVAD recipients off support .


http://www.clinicaltrials.gov .


Unique identifier : NCT01442129 .


Efforts to reduce disparities in recurrent stroke among Black and Latino stroke survivors have met with limited success .


We aimed to determine the effect of peer education on secondary stroke prevention among predominantly minority stroke survivors .


Between 2009 and 2012 , we enrolled 600 stroke or transient ischemic attack survivors from diverse , low-income communities in New York City into a 2-arm randomized clinical trial that compared a 6 week ( 1 session/week ) , peer-led , community-based , stroke prevention self-management group workshop ( N = 301 ) to a wait-list control group ( N = 299 ) .


The primary outcome was the proportion with a composite of controlled blood pressure ( < 140/90 mm Hg ) , low-density lipoprotein cholesterol < 100 mg/dL , and use of antithrombotic medications at 6 months .


Secondary outcomes included control of the individual stroke risk factors .


All analyses were by intent-to-treat .


There was no difference in the proportion of intervention and control group participants achieving the composite outcome ( 34 % versus 34 % ; P = 0.98 ) .


The proportion with controlled blood pressure at 6 months was greater in the intervention group than in the control group ( 76 % versus 67 % ; P = 0.02 ) .


This corresponded to a greater change in systolic blood pressure in the intervention versus control group ( -3.63 SD , 19.81 mm Hg versus +0.34 SD , 23.76 mm Hg ; P = 0.04 ) .


There were no group differences in the control of cholesterol or use of antithrombotics .


A low-cost peer education self-management workshop modestly improved blood pressure , but not low-density lipoprotein cholesterol or antithrombotic use , among stroke and transient ischemic attack survivors from vulnerable , predominantly minority urban communities .


http://www.clinicaltrials.gov/show/NCT0102727 .


Unique identifier : NCT01027273 .


Despite 30 years of clinical research , we still do not know the optimal dose of intrathecal morphine ( ITM ) when used alone .


A safety investigation and comparison of the analgesic efficacy of ITM 0.2 mg , 0.5 mg , and 1 mg in patients undergoing major abdominal cancer surgery .


A randomized , double-blind trial .


Academic medical center .


Ninety patients were randomly assigned to receive morphine intrathecally either 0.2 mg ( Group I , ITM 0.2 mg , n = 30 ) , 0.5 mg ( Group II , ITM 0.5 mg , n = 30 ) , or 1 mg ( Group III , ITM 1 mg , n = 30 ) dissolved in 5 mL physiological saline before general anesthesia .


Assessment parameters included hemodynamics , respiratory rate , peripheral arterial oxygenation , sedation score , pain severity , time of first analgesic request , total analgesic consumption , and side effects in the first 72 hours .


The mean time to first request for rescue analgesia was significantly prolonged in Group II ( 22.13 5.21 hours , P < 0.001 ) and Group III ( 30.83 4.89 h , P < 0.001 ) , compared with Group I ( 0.50 0.66 hours ) .


The mean tramadol consumption dose was significantly reduced in Group II ( 383.33 91.28 mg , P < 0.001 ) and Group III ( 300 69.48 mg , P < 0.001 ) compared with Group I ( 770 114.92 mg ) .


Patients received 1 mg ITM showed lower VAS scores in the first 48 h postoperative ( P < 0.04 ) compared with Group I and Group II .


No significant differences were observed in the mean systolic and diastolic blood pressure values , respiratory rate , and peripheral arterial oxygen saturation between groups .


Lower mean heart rate values were observed in Group III patients at 6 hours ( P < 0.01 ) and 12 hours ( P < 0.03 ) postoperative compared with Group I and Group II patients .


Six patients ( 20 % ) in Group II and 8 ( 26.7 % ) in Group III exhibited pruritus compared with 2 patients ( 6.66 % ) in Group I ( P < 0.01 ) .


No intergroup statistical differences were observed for other studied side effects .


This study is limited by its small sample size .


One mg ITM provided superior analgesia for 48 hours postoperative compared with 0.2 mg and 0.5 mg ITM with a nonsignificant difference in the incidence of side effects .


Further studies of larger sample size are recommended to confirm these findings .


To study the efficacy of Huai Qi Huang granules in the treatment of childhood primary nephrotic syndrome .


Between July 2009 and December 2011 , patients who were admitted and diagnosed for the first time as childhood primary nephrotic syndrome were randomized into a treatment group ( Huai Qi Huang granules plus glucocorticoid ; n = 23 ) and a control group ( glucocorticoid alone ; n = 19 ) for a prospective study .


The two groups were compared for regression time of edema , time to urinary protein clearance , relapse rate , incidence of infection , dosage of glucocorticoid , and humoral and cellular immunological indicators .


There were no significant differences in regression time of edema , time to urinary protein clearance , and relapse rate between the treatment and control groups ( P > 0.05 ) .


The treatment group had significantly lower incidence of infection and daily dose of glucocorticoid ( at month 6 ) than the control group ( P < 0.05 ) .


Humoral and cellular immunological indicators showed no significant differences between the two groups ( P > 0.05 ) .


No Huai Qi Huang-related adverse events were observed in this study .


Huai Qi Huang granules treatment can reduce the dose of glucocorticoid and the incidence of infection in children with primary nephrotic syndrome and has a favourable safety .


Bowel cleansing is generally regarded as time-consuming and unpleasant among patients .


Patients commonly state that bowel preparation provokes more discomfort than the actual colonoscopic examination .


The purpose of this study was to compare two regimens of sodium phosphate ( NaP ) tablets versus polyethylene glycol ( PEG ) solution for bowel preparation in healthy Korean adults .


This was a single center , prospective , open-label , investigator-blinded , randomized , controlled-pilot study .


A total of 62 healthy Korean subjects were randomly assigned to two groups ( NaP vs. PEG ) .


Efficacy , safety , and patient-related outcomes , as well as procedural parameters , were evaluated .


Although there were no significant differences in total Ottawa bowel quality score , fluid scores and the rate of adequate bowel preparation were significantly better in the NaP group than the PEG group .


Additionally , the NaP group showed better results regarding patient tolerance , satisfaction , preference , and rate of adverse events than the PEG group .


Significant fluctuations in specific serum electrolytes were common and of a greater magnitude in the NaP group than the PEG group .


However , these abnormalities were transient and did not result in serious complications and side effects .


In this study , NaP tablets were shown to be an effective , well-tolerated , and acceptable regimen for bowel preparation .


Also , our study suggests that NaP tablets may be safe and can be used as a bowel cleansing agent in healthy adults undergoing elective colonoscopy .


Further multicenter , large scale studies are needed to confirm these findings .


Nepal is on track to achieve MDG 5 but there is a huge sub-national disparity with existing high maternal mortality in western and hilly regions .


The national priority is to reduce this disparity to achieve the goal at sub-national level .


Evidences from developing countries show that increasing utilization of skilled attendant at birth is an important indicator for reducing maternal death .


Further , there is a very low utilization during childbirth in western and hilly regions of Nepal which clearly depicts the barriers in utilization of skilled birth attendants .


So , there is a need to overcome the identified barriers to increase the utilization thereby decreasing the maternal mortality .


The hypothesis of this study is that through a package of interventions the utilization of skilled birth attendants will be increased and hence improve maternal health in Nepal .


This study involves a cluster randomized controlled trial involving approximately 5000 pregnant women in 36 clusters .


The 18 intervention clusters will receive the following interventions : i ) mobilization of family support for pregnant women to reach the health facility , ii ) availability of emergency funds for institutional childbirth , iii ) availability of transport options to reach a health facility for childbirth , iv ) training to health workers on communication skills , v ) security provisions for SBAs to reach services 24/24 through community mobilization ; 18 control clusters will not receive the intervention package .


The final evaluation of the intervention is planned to be completed by October 2014 .


Primary study output of this study is utilization of SBA services .


Secondary study outputs measure the uptake of antenatal care , post natal checkup for mother and baby , availability of transportation for childbirth , operation of emergency fund , improved reception of women at health services , and improved physical security of SBAs .


The intervention package is designed to increase the utilization of skilled birth attendants by overcoming the barriers related to awareness , finance , transport , security etc. .


If proven effective , the Ministry of Health has committed to scale up the intervention package throughout the country .


ISRCTN78892490 .


Progressive midlife weight gain is associated with multiple adverse health outcomes and may represent an early manifestation of insulin resistance in a distinct subset of women .


Emerging data implicate hyperinsulinema as a proximate cause of weight gain and support strategies that attenuate insulin secretion .


To assess a previously reported novel hypocaloric carbohydrate modified diet alone ( D ) , and in combination with metformin ( M ) and metformin plus low-dose rosiglitazone ( MR ) , in diverse women with midlife weight gain ( defined as > 20lbs since the twenties ) , normal glucose tolerance , and hyperinsulinemia .


46 women , mean age 46.61.0 , BMI 30.50.04 kg/m2 , 54.5 % white , 22.7 % black , 15.9 % Hispanic , at 2 university medical centers .


A dietary intervention designed to reduce insulin excursions was implemented in 4 weekly nutritional group workshops prior to randomization .


Change in 6-month fasting insulin .


Pre-specified secondary outcomes were changes in body weight , HOMA-IR , metabolic syndrome ( MS ) measures , leptin , and adiponectin .


Six-month fasting insulin declined significantly in the M group : 12.5 to 8.0 U/ml , p = .026 .


Mean 6-month weight decreased significantly and comparably in D , M , and MR groups : 4.7 , 5.4 , and 5.5 % ( p 's .049 , .002 , and .032 ) .


HOMA-IR decreased in M and MR groups ( 2.5 to 1.6 and 1.9 to 1.3 , p 's = .054 , .013 ) .


Additional improvement in MS measures included reduced waist circumference in D and MR groups and increased HDL in the D and M groups .


Notably , mean fasting leptin did not decline in a subset of subjects with weight loss ( 26.152.01 ng/ml to 25.992.61 ng/ml , p = .907 .


Adiponectin increased significantly in the MR group ( 11.11.0 to 18.57.4 , p < .001 ) Study medications were well tolerated .


These findings suggest that EMPOWIR 's easily implemented dietary interventions , alone and in combination with pharmacotherapies that target hyperinsulinemia , merit additional investigation in larger , long-term studies .


ClinicalTrials.gov NCT00618072 .


Virtual reality ( VR ) is not commonly used in clinical rehabilitation , and commercial VR gaming systems may have mixed effects in patients with stroke .


Therefore , we developed RehabMaster , a task-specific interactive game-based VR system for post-stroke rehabilitation of the upper extremities , and assessed its usability and clinical efficacy .


A participatory design and usability tests were carried out for development of RehabMaster with representative user groups .


Two clinical trials were then performed .


The first was an observational study in which seven patients with chronic stroke received 30 minutes of RehabMaster intervention per day for two weeks .


The second was a randomised controlled trial of 16 patients with acute or subacute stroke who received 10 sessions of conventional occupational therapy only ( OT-only group ) or conventional occupational therapy plus 20 minutes of RehabMaster intervention ( RehabMaster + OT group ) .


The Fugl-Meyer Assessment score ( FMA ) , modified Barthel Index ( MBI ) , adverse effects , and drop-out rate were recorded .


The requirements of a VR system for stroke rehabilitation were established and incorporated into RehabMaster .


The reported advantages from the usability tests were improved attention , the immersive flow experience , and individualised intervention .


The first clinical trial showed that the RehabMaster intervention improved the FMA ( P = .03 ) and MBI ( P = .04 ) across evaluation times .


The second trial revealed that the addition of RehabMaster intervention tended to enhance the improvement in the FMA ( P = .07 ) but did not affect the improvement in the MBI .


One patient with chronic stroke left the trial , and no adverse effects were reported .


The RehabMaster is a feasible and safe VR system for enhancing upper extremity function in patients with stroke .


The volume of a fibroid uterus before performing hysterectomy is typically estimated through bimanual examination and confirmed by ultrasonography .


This study compares estimated volumes by bimanual examination and ultrasound examination with MRI and actual volumes obtained from histopathology , as gold standards .


We used data from a previous prospective randomized multi-center trial that compared hysterectomy and uterine artery embolization ( UAE ) for the treatment of symptomatic fibroids .


All patients underwent bimanual vaginal examination and pelvic ultrasonography .


Those women randomized to UAE received a pelvic MRI .


For women randomized to hysterectomy , the exact uterine volume was based on histopathologic examination .