Fluid distribution was determined by Bioelectrical Impedance Analyzer ( BIA ) and the difference between two groups was compared regarding complications and the relationship between complications and fluid distribution changes .


The restricted intravenous fluid regimen significantly reduced perioperative intravenous fluid volume .


Weight gained in S group and was not significantly changed in R group after surgery , especially in POD2 ( media ; R vs. S ; 61.17 vs. 65.40 kg , p = 0.017 ) .


The number of patients with postoperative complications was reduced in R group compared with in S group ( 34.5 % vs. 47.8 % , p = 0.076 ) .


Systemic complications were significantly reduced in R group ( t = -5.895 , p = 0.000 ) .


Patients with complications had an average of 1.6 complications in R group vs. 2.0 in S group ( t = -1.345 , p = 0.183 ) .


The multivariate analysis suggested that perioperative fluid distribution changes were associated with the development of postoperative complications .


Perioperative fluid restriction could effect on fluid distribution and reduce tissue and cellular edema , and further , could reduce postoperative complication rates .


Vitamin D deficiency is associated with obesity ; whether repletion supports weight loss and changes obesity-related biomarkers is unknown .


We compared 12 mo of vitamin D3 supplementation with placebo on weight , body composition , insulin , and C-reactive protein ( CRP ) in postmenopausal women in a weight-loss intervention .


A total of 218 overweight/obese women ( 50-75 y of age ) with serum 25-hydroxyvitamin D [ 25 ( OH ) D ] 10 ng/mL but < 32 ng/mL were randomly assigned to weight loss + 2000 IU oral vitamin D3/d or weight loss + daily placebo .


The weight-loss intervention included a reduced-calorie diet ( 10 % weight loss goal ) and 225 min/wk of moderate-to-vigorous aerobic activity .


Mean 12-mo changes in weight , body composition , serum insulin , CRP , and 25 ( OH ) D were compared between groups ( intent-to-treat ) by using generalized estimating equations .


A total of 86 % of participants completed the 12-mo measurements .


The mean ( 95 % CI ) change in 25 ( OH ) D was 13.6 ( 11.6 , 15.4 ) ng/mL in the vitamin D3 arm compared with -1.3 ( -2.6 , -0.3 ) ng/mL in the placebo arm ( P < 0.0001 ) .


Changes in weight [ -7.1 ( -8.7 , -5.7 ) compared with -7.4 ( -8.1 , -5.4 ) kg ] , body mass index ( in kg/m ( 2 ) : both -2.8 ) , waist circumference [ -4.9 ( -6.7 , -2.9 ) compared with -4.5 ( -5.6 , -2.6 ) cm ] , percentage body fat [ -4.1 ( -4.9 , -2.9 ) compared with -3.5 ( -4.5 , -2.5 ) ] , trunk fat [ -4.1 ( -4.7 , -3.0 ) compared with -3.7 ( -4.3 , -2.9 ) kg ] , insulin [ -2.5 ( -3.4 , -1.7 ) compared with -2.4 ( -3.3 , -1.4 ) U/mL ] , and CRP [ -0.9 ( -1.2 , -0.6 ) compared with -0.79 ( -0.9 , -0.4 ) mg/L ] [ corrected ] were similar between groups ( all P > 0.05 ) .


Compared with women who achieved 25 ( OH ) D < 32 ng/mL , women randomly assigned to vitamin D who became replete ( ie , 25 ( OH ) D 32 ng/mL ) lost more weight [ -8.8 ( -11.1 , -6.9 ) compared with -5.6 ( -7.2 , -5.0 ) kg ; P = 0.05 ] , waist circumference [ -6.6 ( -9.3 , -4.3 ) compared with -2.5 ( -4.6 , -2.0 ) cm ; P = 0.02 ] , and percentage body fat [ -4.7 ( -6.1 , -3.5 ) compared with -2.6 ( -3.9 , -2.2 ) ; P = 0.04 ] .


Among women with complete pill counts ( 97 % adherence ) , the mean decrease in CRP was 1.18 mg/mL ( 46 % ) in the vitamin D arm compared with 0.46 mg/mL ( 25 % ) in the placebo arm ( P = 0.03 ) .


Vitamin D3 supplementation during weight loss did not increase weight loss or associated factors compared with placebo ; however , women who became replete experienced greater improvements .


This trial was registered at clinicaltrials.gov as NCT01240213 .


To determine the initial efficacy of a mailed screening and brief intervention to reduce at-risk drinking in persons aged 50 and older .


Pilot randomized controlled trial .


University of California at Los Angeles Department of Medicine Community Offices and Primary Care Network .


Individuals aged 50 and older who were identified as at-risk drinkers according to the Comorbidity Alcohol Risk Evaluation Tool ( CARET ) ( N = 86 ) .


Participants were assigned randomly to receive personalized mailed feedback outlining their specific risks associated with alcohol use , an educational booklet on alcohol and aging , and the National Institutes of Health Rethinking Drinking : Alcohol and Your Health booklet ( intervention group ) or nothing ( control group ) .


Alcohol-related assessments at baseline and 3 months ; CARET-assessed at-risk drinking , number of risks , and types of risks .


At 3 months , fewer intervention group participants than controls were at-risk drinkers ( 66 % vs 88 % ) , binge drinking ( 45 % vs 68 % ) , using alcohol with a medical or psychiatric condition ( 3 % vs 17 % ) , or having symptoms of such a condition ( 29 % vs 49 % ) .


A brief mailed intervention may be an effective approach to intervening with at-risk drinkers aged 50 and older .


Tobacco cessation medication adherence is one of the few factors shown to improve smoking cessation rates among methadone-maintained smokers , but interventions to improve adherence to smoking cessation medications have not yet been tested among methadone treatment patients .


Methadone clinic-based , directly observed therapy ( DOT ) programs for HIV and tuberculosis improve adherence and clinical outcomes , but have not been evaluated for smoking cessation .


We describe a randomized controlled trial to evaluate whether a methadone clinic-based , directly observed varenicline therapy program increases adherence and tobacco abstinence among opioid-dependent drug users receiving methadone treatment .


We plan to enroll 100 methadone-maintained smokers and randomize them to directly observed varenicline dispensed with daily methadone doses or treatment as usual ( self-administered varenicline ) for 12weeks .


Our outcome measures are : 1 ) pill count adherence and 2 ) carbon monoxide-verified tobacco abstinence .


We will assess differences in adherence and abstinence between the two treatment arms using repeated measures models .


This trial will allow for rigorous evaluation of the efficacy of methadone clinic-based , directly observed varenicline for improving adherence and smoking cessation outcomes .


This detailed description of trial methodology can serve as a template for the development of future DOT programs and can guide protocols for studies among opioid-dependent smokers receiving methadone treatment .


clinicaltrials.gov NCT01378858 .


Preoperative patient education is an important part of the informed consent process , and a perceived lack of information can lower patient satisfaction .


We sought to evaluate the effect of a web-based multimedia patient education tool on the perioperative experience of patients undergoing first-time knee arthroscopy for a meniscal tear .


Adult patients undergoing knee arthroscopy for the first time for a primary diagnosis of a meniscal tear were consecutively enrolled into the study from January 2014 through June 2014 .


Patients were equally randomized to a control group , who received standard preoperative counseling , or the intervention group , who completed a twenty-minute web-based multimedia tutorial in addition to standard counseling .


The web-based tutorial covered relevant anatomy , pathology , and general perioperative instructions , and it was completed prior to the preoperative visit .


Patients completed surveys that evaluated their preparedness for surgery and knowledge recall at the preoperative visit , on the day of surgery , and after the first postoperative visit .


Sixty-four patients were enrolled , and fifty-five patients ( 86 % ; twenty-nine in the control group and twenty-six in the intervention group ) with complete data sets were included in the analysis .


Preoperatively , the intervention group felt significantly more informed about the surgery and more clearly understood the risks and benefits of , and alternatives to , the surgery ( all p < 0.001 ) .


Postoperatively , the intervention group reported being significantly more satisfied with the perioperative education that they had received and felt more informed about their surgery and rehabilitation ( p 0.05 ) .


Patients in the intervention group were significantly more likely to correctly answer questions regarding their surgical details at the first postoperative visit ( p 0.03 ) .


Patients who completed the web-based tutorial had improved preoperative knowledge and preparedness as well as enhanced postoperative knowledge recall regarding their surgical procedure .


The tutorial received high user satisfaction scores with low user burden scores and was an effective tool for enhancing the patients ' perioperative experience .


Postmenopausal women have substantial concerns about weight gain when quitting smoking , which may contribute smoking relapse .


There is a need for smoking cessation and weight gain prevention programs effective in this population .


Two formats of a smoking cessation/weight gain prevention follow-up intervention in postmenopausal weight concerned women were compared : a minimally-tailored group format and a highly tailored , multidisciplinary individual format .


Effects on sustained abstinence and postcessation weight gain were assessed .


Postmenopausal smokers received 6 sessions of behavioral counseling over a 2-week period , 8weeks of the nicotine transdermal patch , and subsequent random assignment to receive follow-up relapse prevention sessions at 1 , 3 , 8 , and 16weeks postcessation in either group or individual format .


The sample ( N = 98 ) was 67 % Caucasian and 33 % African-American .


Age : m = 52.3 ( 7.8 ) years , follicle stimulating hormone : m = 42.6 ( 25.7 ) , body mass index ( BMI ) : m = 27.4 ( 6.2 ) , daily smoking rate : m = 20.3 ( 11.5 ) , for m = 29.4 ( 10.7 ) years , Fagerstrm Test for Nicotine Dependence ( FTND ) : m = 6.4 ( 2.1 ) , and carbon monoxide : m = 23.8 ( 13.0 ) ppm .


Abstinence rates in the group condition were significantly higher at 8weeks posttreatment .


Group format significantly predicted abstinence rates at 8 and 16weeks posttreatment , even while controlling for age , race , BMI , CPD , years smoking , FTND , and weight concern .


Weight concern predicted postcessation weight gain at 8 and 16weeks posttreatment .


Results indicate that smoking cessation programs for postmenopausal women may best be delivered in a group format and that postcessation weight concerns be dealt with prior to a quit date .


Prevailing recommendations call for restricting intake of dietary cholesterol and eggs for those at risk of heart disease , despite accumulating evidence challenging this association .


Our prior studies showed no short-term adverse effects of daily egg intake on cardiac risk factors in at-risk adults .


We conducted this study to determine effects of daily egg consumption in adults with established coronary artery disease ( CAD ) .


Randomized , controlled , single-blind , crossover trial of 32 adults ( mean age , 67 years ; 6 women , 26 men ) with CAD assigned to 1 of 6 possible sequence permutations of 3 different treatments ( breakfast with 2 eggs , breakfast with cup Egg Beaters , ConAgra Foods , St. Louis , MO , or a high-carbohydrate breakfast part of an ad libitum diet ) for 6 weeks , with 4-week washout periods .


The primary outcome measure was endothelial function measured as flow-mediated dilatation .


Compared with the control breakfast ( ie , high-carbohydrate breakfast ) , daily consumption of eggs showed no adverse effects on flow-mediated dilatation ( 7.2 % 2.9 % vs 7.5 % 2.9 % , P = .33 ) , lipids ( total cholesterol : 158.3 28.6 mg/dL vs 156.2 27.4 mg/dL , P = .49 ) , blood pressure ( systolic blood pressure : 132.8 14.1 mm Hg or vs 135.5 14.9 mm Hg , P = .52 ; diastolic blood pressure : 77.2 6.1 mm Hg vs 76.7 6.9 mm Hg , P = .86 ) , or body weight ( 90.8 17.5 kg vs 91.8 17.1 kg , P = .92 ) .


No outcomes differed ( P > .05 ) between eggs and Egg Beaters .


We found no evidence of adverse effects of daily egg ingestion on any cardiac risk factors in adults with CAD over a span of 6 weeks .


To evaluate the effectiveness of a professional one-to-one antenatal breastfeeding support and education intervention on the exclusivity and duration of breastfeeding .


A total of 469 primiparous women who attended the antenatal clinics of two geographically distributed public hospitals in Hong Kong were randomized to receive either standard antenatal care or a one-to-one antenatal breastfeeding support and education session .


The primary outcome was the prevalence of exclusive breastfeeding at 6 weeks postpartum .


Secondary outcomes were the prevalence of exclusive breastfeeding at 3 and 6 months postpartum as well as the overall duration of any and exclusive breastfeeding across the first 6 months postpartum .


The exclusive breastfeeding rate in the intervention group was 37.8 % at 6 weeks postpartum compared with 36.4 % in the standard care group ( P = .77 ; 95 % confidence interval [ CI ] -0.08 to 0.11 ) .


There were no significant differences between the two treatment groups in exclusive breastfeeding rates at 3 and 6 months or in the overall duration of any ( hazard ratio [ HR ] 1.11 , 95 % CI 0.88-1 .40 ] or exclusive breastfeeding ( HR 0.96 , 95 % CI 0.79-1 .17 ) .


The study had a least 80 % power to detect a 50 % increase in the rate of exclusive breastfeeding at 6 weeks postpartum .


In a setting with a high breastfeeding initiation rate , one-to-one antenatal breastfeeding support and education did not increase the exclusivity or duration of breastfeeding .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT01648114 .


Individuals on hemodialysis have low physical function and activity levels .


Clinical trials have shown improvements in these parameters with exercise programming .


Pedometers have not been extensively evaluated in individuals on hemodialysis .


This randomized clinical trial compared the effects of intradialytic cycling versus a pedometer program on physical function , physical activity and quality of life .


Sixty patients were randomly assigned to two study groups .


The ergometer group cycled during each hemodialysis session for 24 weeks .


Pedometer participants followed a home-based walking program for 24 weeks .


The primary outcome was aerobic capacity [ VO2peak and 6-minute walk ( 6MW ) test ] .


Secondary outcomes included lower extremity strength [ sit-to-stand ( SS ) test ] , flexibility [ sit-and-reach ( SR ) test ] , physical activity ( accelerometer ) and health-related quality of life .


Measurements were collected at baseline and at 12 and 24 weeks .


At 12 and 24 weeks , there was no significant change in the VO2peak or 6MW test between or within study groups .


SS testing in the ergometer group improved from 10.2 ( SD 3.4 ) to 11.4 ( SD 2.5 ) cycles from baseline to 24 weeks ( P < 0.005 ) .


Similarly , in the pedometer group , SS cycles improved from 10.1 ( SD 3.3 ) to 12.2 ( SD 3.5 ) ( P < 0.005 ) .


The SR test also significantly improved over time in both the study groups .


No significant changes were noted for other secondary outcomes .


Both intradialytic cycling and pedometer programming improved aspects of physical function .


Neither intervention had a significant effect on aerobic capacity .


No significant differences in any outcomes were identified between interventions groups .


Spondylolisthesis is the major cause of refractory low back pain .


There are many studies of the surgical treatment of spondylolisthesis , but few of conservative treatments .


There is also no optimal conservative treatment protocol , however , low back pain caused by low-grade spondylolisthesis is controlled with non-surgical pain management .


Acupuncture has become a useful method for treating low back pain , but there has not been any study of its efficacy in relation to spondylolisthesis .


This study was designed to establish the feasibility of a randomized controlled trial and the safety of acupuncture for low back pain due to low-grade spondylolisthesis .


The study is a randomized controlled pilot clinical trial of five weeks duration .


Fourteen patients will be recruited and randomly allocated to two groups : an acupuncture plus interlaminar epidural steroid injection group ( experimental group ) , and an interlaminar epidural steroid injection group ( control group ) .


All patients will be administered an interlaminar epidural steroid injection once a week for three weeks ( three injections in total ) , but only the experimental group will receive additional treatment with three acupuncture sessions a week for three weeks ( nine acupuncture sessions in total ) .


The primary outcome will be measured by the visual analogue scale ( VAS ) .


Our primary end point is three-week VAS .


The secondary outcome will be measured using the PainVision system , the short-form McGill Pain Questionnaire , and the Oswestry Disability Index .


Assessments will be made at baseline and at one , three and five weeks thereafter ( that is , the five-week assessment will be made two weeks after treatment cessation ) .


This randomized controlled pilot trial will inform the design of a further full-scale trial .


The outcomes will provide some resources for incorporating acupuncture into existing pain management methods such as interlaminar epidural steroid injection in low-grade spondylolisthesis .


This trial is registered with the US National Institutes of Health Clinical Trials registry : NCT01909284 .


Opioid-induced respiratory depression is potentially lethal .


GAL021 is a calcium-activated potassium ( BKCa ) channel blocker that causes reversal of opioid-induced respiratory depression in animals due to a stimulatory effect on ventilation at the carotid bodies .


To assess in humans whether GAL021 stimulates breathing in established opioid-induced respiratory depression and to evaluate its safety , a proof-of-concept double-blind randomized controlled crossover study on isohypercapnic ventilation ( study 1 ) and subsequent double-blind exploratory study on poikilocapnic ventilation and nonrespiratory end points ( study 2 ) was performed .


In study 1 , intravenous low - and high-dose GAL021 and placebo were administrated on top of low - and high-dose alfentanil-induced respiratory depression in 12 healthy male volunteers on two separate occasions .


In study 2 , the effect of GAL021/placebo on poikilocapnic ventilation , analgesia , and sedation were explored in eight male volunteers .


Data are mean difference between GAL021 and placebo ( 95 % CI ) .


Study 1 : Under isohypercapnic conditions , a separation between GAL021 and placebo on minute ventilation was observed by 6.1 ( 3.6 to 8.6 ) l/min ( P < 0.01 ) and 3.6 ( 1.5 to 5.7 ) l/min ( P < 0.01 ) at low-dose alfentanil plus high-dose GAL021 and high-dose-alfentanil plus high-dose GAL021 , respectively .


Study 2 : Similar observations were made on poikilocapnic ventilation and arterial pCO2 .


GAL021 had no effect on alfentanil-induced sedation , antinociception and no safety issues or hemodynamic effects became apparent .


GAL021 produces respiratory stimulatory effects during opioid-induced respiratory depression with containment of opioid-analgesia and without any further increase of sedation .


Further studies are needed to confirm these preliminary data .


To compare the clinical outcomes and the rate of complications of 27-gauge transconjunctival nonvitrectomizing vitreous surgery ( NVS ) and of 25-gauge transconjunctival sutureless vitrectomy surgery for idiopathic epiretinal membrane removal .


In this prospective randomized study , 83 phakic eyes of 83 consecutive patients with an idiopathic epiretinal membrane were randomized to receive 27-gauge NVS ( NVS-group ) or 25-gauge vitrectomy ( Standard-group ) .


Main outcome measures were best-corrected visual acuity , central retinal thickness , nuclear density units ' changes , and rate of complications .


Thirty-nine eyes of the Standard-group and 40 of the NVS-group were considered in final analysis .


Mean best-corrected visual acuity improved significantly in both groups , with a significant better result at 12 months in NVS-group ( P = 0.039 ; t-test ) .


Central retinal thickness decreased significantly in both groups ( P < 0.001 , Tukey test ) , without significant difference between the two groups at any time point .


At 12 months , nuclear density increased significantly in the Standard-group ( analysis of variance , P < 0.001 ) , and it did not change in the NVS-group ( analysis of variance , P = 0.537 ) .


Epiretinal membrane recurred in 5.1 % of eyes in the Standard-group and in 7.5 % of eyes in the NVS-group ( Fisher 's exact test , P = 1.000 ) .


The 27-gauge NVS is an effective surgical procedure in eyes with epiretinal membrane and it induces less progression of nuclear sclerosis than 25-gauge vitrectomy .


National data suggest a higher prevalence of obesity among boys .


One possible cause could be the food choices made by parents on behalf of their children .


This study sought to determine whether and how mothers ' food choices for their children differ by child gender and to understand the drivers of these differences .


Data were analyzed from a randomized controlled trial conducted using a virtual reality-based buffet restaurant .


Overweight mothers filled out questionnaires and received an information module .


They were then immersed in a virtual buffet restaurant to select a lunch for their 4 - to 5-year-old child .


Of the 221 overweight mothers recruited , 55 % identified their daughters as the child for whom they would be choosing the food .


The caloric content of boys ' meals was 43 calories higher than girls ' ( p = .015 ) .


This difference was due to extra calories from the less healthy food category ( p = .04 ) .


Multivariate analyses identified more predictors of calorie choices for daughters ' than sons ' meals .


Predictors of calories chosen for girls included : having both biological parents overweight ( = 0.26 ; p = .003 ) , mother 's weight ( = 0.17 ; p = .05 ) , mother 's education ( = -0.28 ; p = .001 ) , her restriction of her child 's food intake ( = -0.20 ; p = .02 ) , and her beliefs about the importance of genetics in causing obesity ( = 0.19 ; p = .03 ) .


Mother 's weight was the sole predictor of boys ' meal calories ( = 0.20 ; p = .04 ) .


Differences in dietary choices made for young girls and boys may contribute to lifelong gender differences in eating patterns .


A better understanding of differences in feeding choices made for girls versus boys could improve the design of childhood obesity prevention interventions .


We evaluated the ability of 23 genetic variants to provide prognostic information in patients enrolled in the Genetic Substudy of the Surgical Treatment for Ischemic Heart Failure ( STICH ) trials .


Patients assigned to STICH Hypothesis 1 were randomized to medical therapy with or without coronary artery bypass grafting ( CABG ) .


Those assigned to STICH Hypothesis 2 were randomized to CABG or CABG with left ventricular reconstruction .


In patients assigned to STICH Hypothesis 2 ( n = 714 ) , no genetic variant met the prespecified Bonferroni-adjusted threshold for statistical significance ( p < 0.002 ) ; however , several variants met nominal prognostic significance : variants in the 2-adrenergic receptor gene ( 2-AR Gln27Glu ) and in the A1-adenosine receptor gene ( A1-717 T/G ) were associated with an increased risk of a subject dying or being hospitalized for a cardiac problem ( p = 0.027 and 0.031 , respectively ) .


These relationships remained nominally significant even after multivariable adjustment for prognostic clinical variables .


However , none of the 23 genetic variants influenced all-cause mortality or the combination of death or cardiovascular hospitalization in the STICH Hypothesis 1 population ( n = 532 ) by either univariate or multivariable analysis .


We were unable to identify the predictive genotypes in optimally treated patients in these two ischemic heart failure populations .


In rodent models of diabetes , treatment with sodium glucose co-transporter 2 ( SGLT2 ) inhibitors improves beta cell function .


This analysis assessed the effects of the SGLT2 inhibitor , canagliflozin , on model-based measures of beta cell function in patients with type 2 diabetes .


Data from three Phase 3 studies were analysed , in which : ( Study 1 ) canagliflozin 100 and 300 mg were compared with placebo as monotherapy for 26 weeks ; ( Study 2 ) canagliflozin 100 and 300 mg were compared with placebo as add-on to metformin + sulfonylurea for 26 weeks ; or ( Study 3 ) canagliflozin 300 mg was compared with sitagliptin 100 mg as add-on to metformin + sulfonylurea for 52 weeks .


In each study , a subset of patients was given mixed-meal tolerance tests at baseline and study endpoint , and model-based beta cell function parameters were calculated from plasma glucose and C-peptide .


In Studies 1 and 2 , both canagliflozin doses increased beta cell glucose sensitivity compared with placebo .


Placebo-subtracted least squares mean ( LSM ) ( SEM ) changes were 23 ( 9 ) and 18 ( 9 ) pmol min ( -1 ) m ( -2 ) ( mmol/l ) ( -1 ) with canagliflozin 100 and 300 mg , respectively ( p < 0.002 , Study 1 ) , and 16 ( 8 ) and 10 ( 9 ) pmol min ( -1 ) m ( -2 ) ( mmol/l ) ( -1 ) ( p < 0.02 , Study 2 ) .


In Study 3 , beta cell glucose sensitivity was minimally affected , but the insulin secretion rate at 9 mmol/l glucose increased to similar degrees from baseline with canagliflozin and sitagliptin [ LSM ( SEM ) changes 38 ( 8 ) and 28 ( 9 ) pmol min ( -1 ) m ( -2 ) , respectively ; p < 0.05 for both ] .


Treatment with canagliflozin for 6 to 12 months improved model-based measures of beta cell function in three separate Phase 3 studies .


Clinicaltrials.gov NCT01081834 ( Study 1 ) ; NCT01106625 ( Study 2 ) ; NCT01137812 ( Study 3 ) .


To examine whether a Web-based cardiovascular health promotion program was associated with changes in self-reported behaviors , attitudes , and biometric indicators in a population of working adults .


Employees ( n = 210 ) were recruited and randomized into either an Internet-based or control condition .


Participants completed pre - and postintervention self-report assessments on diet , exercise , smoking , and mental health .


Pre - and postintervention biometric screenings were also obtained on blood pressure , heart rate , weight , and hip/waist circumference .


The intervention was associated with significant improvements in dietary attitudes ( P = 0.003 ; F = 8.83 ) , dietary intentions ( P = 0.031 ; F = 4.72 ) , dietary self-efficacy ( P = 0.015 ; F = 5.97 ) , exercise self-efficacy ( P = 0.002 ; F = 9.51 ) , exercise habits ( P = 0.016 ; F = 5.94 ) , and coping with stress ( P = 0.003 ; F = 8.85 ) and depression ( P = 0.036 ; F = 4.46 ) .


The program showed promise for promoting cardiovascular risk reduction behaviors .


These results are consistent with similar Web-based interventions .


Minimal hepatic encephalopathy ( MHE ) implies subtle impairment of cognitive functions in the absence of features of overt encephalopathy .


We aimed to determine the prevalence of MHE in patients with liver cirrhosis and to find out the effect of rifaximin , probiotics , and l-ornithine l-aspartate ( LOLA ) individually in reversal of MHE by comparing it with placebo group .


This study was carried out in two phases .


Phase I included the recruitment of 250 apparently healthy controls and extraction of normative data utilizing three neuropsychometric tests ( NPTs ) and critical flicker frequency ( CFF ) test .


Phase II consisted of screening and recruitment of patients of MHE followed by drugs trial .


A total of 317 cirrhotics were screened ; 111 were excluded and the remaining 206 cirrhotics were screened for MHE using NPTs and/or CFF test .


Of these , 124 patients with MHE were randomized to receive LOLA ( n = 31 ) , rifaximin ( n = 31 ) , probiotics ( n = 32 ) , for 2 months and were compared with patients who were given placebo ( n = 30 ) .


Out of 206 cirrhotics , 124 ( 60.19 % ) had MHE .


Among these 124 MHE patients , 87 ( 70.16 % ) patients had CFF < 39Hz , 112 ( 90.32 % ) patients with MHE had two or more abnormal NPTs , and 75 ( 60.48 % ) patients had abnormality on both the CFF values and more than two abnormal NPTs .


Intention-to-treat analysis showed the number of patients who improved after giving treatment were 67.7 % ( 21/31 ) , 70.9 % ( 22/31 ) , 50 % ( 16/32 ) , and 30 % ( 9/30 ) for LOLA , rifaximin , probiotics , and placebo , respectively .


CFF scores and improvement in psychometric tests after treatment were significantly higher ( P < 0.05 ) for LOLA , rifaximin , and probiotics as compared with placebo group .


Prevalence of MHE is high in patients with cirrhosis of liver .


Rifaximin , LOLA , and probiotics are better than giving placebo in patients with MHE .


Endotoxaemia is widely used as an experimental model to study sepsis under controlled conditions .


Nighttime endotoxaemia induces a more pronounced inflammatory stress response compared to daytime .


Previously , we have shown that melatonin has antioxidative and anti-inflammatory effects in inflammatory response to daytime endotoxaemia .


Herein , we examined the effect of melatonin in response to human nighttime endotoxaemia .


Twelve healthy male volunteers were enrolled in a randomized , placebo-controlled , double-blinded cross-over trial .


Subjects were induced by lipopolysaccharide ( LPS ) endotoxin 0.3 ng/kg body weight intravenously at 24:00 .


One hour prior to induction of endotoxaemia , an 8-h infusion of melatonin 100 mg or placebo was initiated .


Blood samples were drawn before and 2 , 4 , 6 and 8 h after induction of endotoxaemia and plasma was tested for pro-inflammatory markers ( tumor necrosis factor alpha , TNF - , interleukin-1 , IL-1 , interleukin-1 , IL-6 , and YKL-40 ) , anti-inflammatory markers ( interleukin-1 receptor antagonist , IL-1Ra , interleukin-10 , IL-10 , soluble tumor necrosis factor receptors I and II , sTNF-RI and sTNF-RII ) , marker for oxidative damage ( malondialdehyde ( MDA ) ) and antioxidative enzyme ( ascorbic acid ( AA ) and dehydroascorbic acid ( DHA ) ) .


Compared to placebo , melatonin did not reduce plasma levels of any of pro- and anti-inflammatory markers and it also failed to influence levels of AA , DHA and MDA .


Melatonin has no beneficial effect on inflammation and oxidative damage induced by nighttime endotoxaemia in contrast to daytime endotoxaemia .


Patients with cirrhosis resulting from chronic hepatitis C virus ( HCV ) infection are at risk of life-threatening complications , but consistently achieve lower sustained virological response ( SVR ) than patients without cirrhosis , especially if treatment has previously failed .


We assessed the efficacy and safety of the NS5A inhibitor ledipasvir and the nucleotide polymerase inhibitor sofosbuvir , with and without ribavirin .


In this multicentre , double-blind trial , between Oct 21 , 2013 , and Oct 30 , 2014 , we enrolled patients with HCV genotype 1 and compensated cirrhosis who had not achieved SVR after successive treatments with pegylated interferon and protease-inhibitor regimens at 20 sites in France .


With a computer-generated randomisation sequence , patients were assigned in a 1:1 ratio to receive placebo matched in appearance to study drugs for 12 weeks followed by once daily combination fixed-dose tablets of 90 mg ledipasvir and 400 mg sofosbuvir plus weight-based ribavirin for 12 weeks , or ledipasvir-sofosbuvir plus placebo once daily for 24 weeks .


The primary endpoint was SVR 12 weeks after the end of treatment ( SVR12 ) , for which 95 % CIs were calculated with the Clopper-Pearson method .


This study is registered with ClinicalTrials.gov , number NCT01965535 .


Of 172 patients screened , 155 entered randomisation , 77 were assigned to receive ledipasvir-sofosbuvir plus ribavirin and 78 ledipasvir-sofosbuvir .


114 ( 74 % ) were men , 151 ( 97 % ) , were white , 98 ( 63 % ) had HCV genotype 1a , and 145 ( 94 % ) had non-CC IL28B alleles .


SVR12 rates were 96 % ( 95 % CI 89-99 ) for patients in the ledipasvir-sofosbuvir plus ribavirin group and 97 % ( 91-100 ) in the ledipasvir-sofosbuvir group .


One patient discontinued treatment because of adverse events while receiving only placebo .


The most frequent adverse events were asthenia and headache , pruritus , and fatigue .


Ledipasvir-sofosbuvir plus ribavirin for 12 weeks and ledipasvir-sofosbuvir for 24 weeks provided similarly high SVR12 rates in previous non-responders with HCV genotype 1 and compensated cirrhosis .


The shorter regimen , when given with ribavirin , might , therefore , be useful to treat treatment-experienced patients with cirrhosis if longer-term treatment is not possible .


Gilead Sciences .


Psychostimulants and cannabis are two of the three most commonly used illicit drugs by young Australians .


As such , it is important to deliver prevention for these substances to prevent their misuse and to reduce associated harms .


The present study aims to evaluate the feasibility and effectiveness of the universal computer-based Climate Schools : Psychostimulant and Cannabis Module .


A cluster randomised controlled trial was conducted with 1734 Year 10 students ( mean age = 15.44 years ; SD = 0.41 ) from 21 secondary schools in Australia .


Schools were randomised to receive either the six lesson computer-based Climate Schools program or their usual health classes , including drug education , over the year .


The Climate Schools program was shown to increase knowledge of cannabis and psychostimulants and decrease pro-drug attitudes .


In the short-term the program was effective in subduing the uptake and plateauing the frequency of ecstasy use , however there were no changes in meth/amphetamine use .


In addition , females who received the program used cannabis significantly less frequently than students who received drug education as usual .


Finally , the Climate Schools program was related to decreasing students ' intentions to use meth/amphetamine and ecstasy in the future , however these effects did not last over time .


These findings provide support for the use of a harm-minimisation approach and computer technology as an innovative platform for the delivery of prevention education for illicit drugs in schools .


The current study indicated that teachers and students enjoyed the program and that it is feasible to extend the successful Climate Schools model to the prevention of other drugs , namely cannabis and psychostimulants .


Australian and New Zealand Clinical Trials Registry ACTRN12613000492752 .


Patients with both major depression and personality disorders have a high risk of suicidal behavior .


Lithium is meant to have anti-suicidal properties in patients with affective disorders .


The anti-suicidal effect of lithium in patients with affective disorders and comorbid personality disorders has not been investigated yet .


A post-hoc analysis of a subsample of patients with depression and comorbid personality disorder ( PD ) and a recent suicide attempt ( n = 19 ) from the prospective , placebo-controlled lithium intervention study ( N = 167 ) , was conducted .


Three patients in the lithium group ( n = 8 ) and two patients in the placebo group ( n = 11 ) presented a suicide attempt throughout the course of the study .


No differences related to suicidal behavior could be detected between the placebo group and the group with lithium intervention .


On the basis of the small sample size , among patients with comorbid PD , lithium does not seem to have an effect on suicidal behavior in contrast to patients with affective disorders without comorbid PD .


Rural Australian adults are continually shown to be insufficiently active with higher prevalence of lifestyle-related diseases associated with physical inactivity compared to urban adults .


This may , partly , be attributable to the challenges associated with implementing community-based physical activity programs in rural communities .


There is a need for broadly accessible physical activity programs specifically tailored to the unique attributes of rural communities .


The aim of the Rural Environments And Community Health ( REACH ) study is to evaluate the effectiveness of an online-delivered physical activity intervention for increasing regular walking among adults living in rural areas of South Australia .


This is a randomised controlled trial .


The intervention is 12-weeks with a 12-month follow-up .


Participants will be insufficiently active , aged 18 to 70years and randomly assigned to either Control or Intervention group .


Participants receive a pedometer , but only the Intervention group will receive access to the purpose built REACH website where they will report steps taken , affect and ratings of perceived exertion during daily walking .


These variables will be used to establish individualised step goals for increasing walking .


Control participants will receive a paper diary to record their variables and generic incremental step goals.The primary outcome measures are time spent in sedentary , light and moderate-to-vigorous intensity physical activity , measured by accelerometry .


Secondary outcomes include 1 ) health measures ( anthropometric and physiological ) , 2 ) psychological well-being , 3 ) diet quality , and 4 ) correlates of physical activity ( exercise self-efficacy and physical activity environments ) .


Measures will be collected at baseline , post-intervention , 6-month and 12-month follow-up .


This protocol describes the implementation of a trial testing the effectiveness of an online resource designed to assist rural Australians to become more physically active .


The outcomes of this study will guide the efforts of health promotion professionals by providing evidence for a relatively inexpensive , widely accessible and effective method for increasing physical activity that can be utilized by anyone with access to the internet .


Findings may indicate future directions for the implementation of physical activity and other health related interventions in rural communities .


Australian New Zealand Clinical Trials Registry : ACTR12614000927628 ( registered 28 August 2014 ) .


To observe the effectiveness of chlortetracycline ( aureomycin ) treatment on vulval white lesions and to explore its possible pathogenesis .


From January 2001 to April 2011 , 194 patients with vulvar non-neoplastic epithelial disorders were divided into three groups according to therapy regimens received , ie , chlortetracycline treatment group ( 72 cases ) , chlortetracycline + beclomethasone treatment group ( 66 cases ) , and beclomethasone treatment group ( 56 cases ) ; their local changes of vulvar lesions were observed and efficacy of these treatment profiles was evaluated after one year .


Effective rates of chlortetracycline group , chlortetracycline + clobetasol group and clobetasol groups were 86.1 % ( 62/72 ) , 87.9 % ( 58/66 ) , and 62.5 % ( 35/56 ) , respectively .


There was a significant difference among these three groups ( Hc = 10.7766 , p = 0.0046 ) , the curative rate of clobetasol group was markedly lower than that of the former two groups ( p = 0.0072 and p = 0.0019 ) , but was not statistical significant ( p = 0.6077 ) when compared between the former groups .


The occurrence of vulvar non-neoplastic epithelial disorders may be associated with chlamydia and mycoplasma infection , the chlortetracycline is an effective drug for this illness , the mechanism of which might be related to killing pathogens directly and inhibiting inflammatory mediators .


Drug-related emergency department ( ED ) visits have steadily increased , with substance users relying heavily on the ED for medical care .


The present study aims to identify clinical correlates of problematic drug use that would facilitate identification of ED patients in need of substance use treatment .


Using previously validated tests , 15,224 adult ED patients across 6 academic institutions were prescreened for drug use as part of a large randomized prospective trial .


Data for 3,240 participants who reported drug use in the past 30 days were included .


Self-reported variables related to demographics , substance use , and ED visit were examined to determine their correlative value for problematic drug use .


Of the 3,240 patients , 2,084 ( 64.3 % ) met criteria for problematic drug use ( Drug Abuse Screening Test score 3 ) .


Age greater than or equal to 30 years , tobacco smoking , daily or binge alcohol drinking , daily drug use , primary noncannabis drug use , resource-intense ED triage level , and perceived drug-relatedness of ED visit were highly correlated with problematic drug use .


Among primary cannabis users , correlates of problematic drug use were age younger than 30 years , tobacco smoking , binge drinking , daily drug use , and perceived relatedness of the ED visit to drug use .


Clinical correlates of drug use problems may assist the identification of ED patients who would benefit from comprehensive screening , intervention , and referral to treatment .


A clinical decision rule is proposed .


The correlation between problematic drug use and resource-intense ED triage levels suggests that ED-based efforts to reduce the unmet need for substance use treatment may help decrease overall health care costs .


Little is known regarding patient characteristics that influence the speed of reflux oesophagitis ( RO ) healing .


To investigate patient characteristics that may influence RO healing rates .


A post hoc analysis of clinical trial data for potent acid suppression treatment of RO ( esomeprazole or AZD0865 ) was conducted .


Group A underwent endoscopy at baseline , week 2 and 4 , and group B at baseline , week 4 and 8 .


Group A patients were sub-grouped as ` rapid ' ( healed at 2 weeks ) or unhealed at 2 weeks .


Group B patients were sub-grouped as ` slow ' ( healed at 8 weeks , not at 4 weeks ) or ` refractory ' ( not healed at 8 weeks ) .


Logistic regression analysis was performed only for comparisons within group A.


At 2 , 4 and 8 weeks , RO had healed in 68 % , 65 % and 61 % of patients unhealed at previous endoscopy , respectively .


Low-grade [ vs. high-grade ( C or D ) ] RO was the only independent predictor of rapid healing in group A after logistic regression analysis .


Significantly more rapid healers had low grade RO ( A or B ) at baseline than patients with refractory RO ( 84 % vs. 49 % ; P < 0.001 ) , and significantly more refractory patients had frequent regurgitation at baseline than slow healers ( 80 % vs. 63 % ; P = 0.039 ) .


Low - ( vs. high - ) grade RO determines the most rapid benefit from acid suppression .


Roughly two-thirds of patients healed with each time increment of potent acid suppression therapy .


This suggests that some unhealed patients may still heal with continued therapy and that truly refractory RO is rare .


( ClinicalTrials.gov : NCT00206245 ) .


To evaluate the effects of levosimendan on hemodynamics and cardiac function in patients with septic shock .


A prospective single-center randomized controlled trial was conducted .


The patients with septic shock admitted to the Department of Critical Care Medicine of the Third Hospital of Hebei Medical University from June 2011 to October 2013 were enrolled .


The patients with septic shock received the conventional treatment according to international guidelines for management of severe sepsis and septic shock .


Thirty-six patients received the examination of echocardiography and left ventricular ejection fraction ( LVEF ) 0.45 after fluid resuscitation were enrolled the study , who were divided into two groups according to random number table , with 18 cases in each group .


After the conventional treatment , the patients in dobutamine group received intravenous injection of 5 g kg min dobutamine for 48 hours immediately after fluid resuscitation , and those in levosimendan group received a 24-hour infusion of 5 g kg min dobutamine followed by a 24-hour infusion of 0.2 g kg min levosimendan .


The hemodynamics and cardiac function were evaluated by pulse indicator continuous cardiac output ( PiCCO ) and ultrasound during treatment .


Compared with dobutamine group , after the treatment in the levosimendan group , stroke volume index ( SVI ) , cardiac index ( CI ) and left ventricular stroke work index ( LVSWI ) were significantly increased [ SVI ( mL/m ) : 39.8 5.4 vs. 37.5 4.5 , t = -2.762 , P = 0.020 ; CI ( L min m ) : 4.6 0.7 vs. 3.6 0.7 , t = -9.829 , P = 0.000 ; LVSWI ( kg min m ) : 33.7 2.4 vs. 28.2 1.2 , t = -6.307 , P = 0.000 ] , and central venous pressure ( CVP ) , intrathoracic blood volume index ( ITBVI ) and extravascular lung water index ( EVLWI ) were significantly decreased [ CVP ( mmHg , 1 mmHg = 0.133 kPa ) : 8.2 0.9 vs. 12.1 0.8 , t = 3.928 , P = 0.002 ; ITBVI ( mL/m ) : 820 42 vs. 978 69 , t = 9.472 , P = 0.000 ; EVLWI ( mL/kg ) : 6.1 1.6 vs. 8.9 1.7 , t = 4.467 , P = 0.001 ] .


Cardiac ultrasound showed that compared with dobutamine group , in the levosimendan group , left ventricular end-systolic volume ( LVESI ) and end-diastolic volume ( LVEDI ) were significantly lowered [ LVESI ( mL/m ) : 32.7 9.2 vs. 48.2 13.4 , t = 0.882 , P = 0.000 ; LVEDI ( mL/m ) : 61.7 11.4 vs. 78.6 13.6 , t = 2.453 , P = 0.032 ] , and the LVEF was significantly increased ( 0.463 0.068 vs. 0.383 .085 , t = -2.439 , P = 0.035 ) .


Levosimendan also could decrease the lactic acid ( mmol/L : 3.4 1.1 vs. 5.2 1.2 , t = 3.346 , P = 0.007 ) , and increase the lactate clearance rate ( mL/min : 73.2 13.5 vs. 47.6 11.8 , t = -4.079 , P = 0.002 ) , 24-hour urinary output ( mL : 2 213.4 354.0 vs. 1 533.8 402.0 , t = 6.342 , P = 0.000 ) and 24-hour cumulative intake ( mL : 5 746.6 420.0 vs. 4 156.7 215.0 , t = 7.126 , P = 0.000 ) .


There were no significant differences in total volume of norepinephrine , mortality in intensive care unit ( ICU ) and 28-day mortality between two groups .


Levosimendan can increase cardiac ejection function , reduce the heart blood and vascular preload , intrathoracic lung water , improve heart function and systemic hemodynamic indexes of patients with septic shock .


Secreted protein acidic and rich in cysteine ( SPARC ) has been suggested as a new biomarker and therapeutic target in breast cancer , as well as other tumor types .


We evaluated the frequency of SPARC expression among different molecular breast cancer subtypes and its role for therapy response after neoadjuvant chemotherapy .


In this study , pretherapeutic core biopsies of 667 patients from the neoadjuvant GeparTrio trial were evaluated for SPARC expression by immunohistochemistry using a standardized immunoreactive score ( IRS ) .


An increased SPARC expression ( IRS 6 ) was observed in 26 % of all tumors .


In triple-negative tumors , SPARC expression was increased in 37 % of tumors , compared with other molecular subtypes ( 23 % HR + / HER2 - , 29 % HR + / HER2 + and 22 % HR - / HER2 + ; P = 0.038 ) .


Increased SPARC expression was associated with an increased pathological complete response ( pCR ) rate of 27 % , compared with 15 % in tumors with low SPARC expression ( P < 0.001 ) .


In the triple-negative subgroup , pCR rates were 47 % in tumors with high SPARC expression , compared with 26 % in tumors with low SPARC expression ( P = 0.032 ) .


In multivariable analysis , SPARC was independently predictive in the overall population ( P = 0.010 ) as well as the triple-negative subgroup ( P = 0.036 ) .


SPARC is frequently expressed in breast cancer with triple-negative breast cancer revealing the highest expression rate .


High SPARC expression of the primary tumor is associated with a higher chance of achieving a pathological complete remission after TAC or TAC-NX chemotherapy .


As SPARC is an albumin-binding protein and might mediate intratumoral accumulation of albumin bound drugs , SPARC should be further evaluated as a predictive marker especially for response to albumin-bound drugs like nab-paclitaxel .


NCT00544765 .


To evaluate health-related quality of life ( HRQOL ) and corticosteroid use in patients with moderate to severely active SLE enrolled in two international , multicentre , randomized controlled trials of epratuzumab ( ALLEVIATE-1 and -2 ) and a long-term extension study ( SL0006 ) .


Ninety ALLEVIATE patients ( 43 % BILAG A , mean BILAG score 13.2 ) were randomized to receive 360 mg/m ( 2 ) ( n = 42 ) or 720 mg/m ( 2 ) ( n = 11 ) epratuzumab or placebo ( n = 37 ) , plus standard of care , in 12-week cycles .


Corticosteroid use , patient and physician global assessments of disease activity ( PtGA and PGA ) and 36-item Medical Outcomes Survey Short Form ( SF-36 ) results were recorded at baseline and every 4 weeks .


Both trials were prematurely discontinued due to a drug supply interruption ; patients followed for 6 months were analysed .


Twenty-nine patients continued in SL0006 , with interim analysis at a median exposure of 120 ( range 13-184 ) weeks .


At week 12 , proportions of patients with a PGA 20 % above baseline or with a PtGA improvement greater than or equal to the minimum clinically important difference were higher in the epratuzumab arms than the placebo arm .


PGA and PtGA improvements were sustained but did not reach statistical significance .


At week 24 , mean cumulative corticosteroid doses with epratuzumab 360 and 720 mg/m ( 2 ) were 1051 and 1973 mg less than placebo ( P = 0.034 and 0.081 , respectively ) .


At week 48 , SF-36 scores approached or exceeded US age - and gender-matched norms in five domains with the 360 mg/m ( 2 ) treatment .


Improvements were maintained in SL0006 over 2 years .


Epratuzumab treatment produced clinically meaningful and sustained improvements in PGA , PtGA and HRQOL and reductions in corticosteroid doses .


In industrialized countries , low back pain ( LBP ) is one of the leading causes for prolonged sick leave , early retirement , and high health care costs .


Providing the same treatments to all patients is neither effective nor feasible , and may impede patients ' recovery .


Recent studies have outlined the need for subgroup-specific treatment allocation .


This is a cross-sectional study that used baseline data from consecutively recruited patients participating in a guideline implementation trial regarding LBP in primary care .


Classification variables were employment status , age , pain intensity , functional capacity ( HFAQ ) , depression ( CES-D ) , belief that activity causes pain ( FABQ subscale ) , 2 scales of the SF-36 ( general health , vitality ) , and days in pain per year .


We performed k-means cluster analyses and split-half cross-validation .


Subsequently , we investigated whether the resulting groups incurred different direct and indirect costs during a 6-month period before the index consultation .


A 4-cluster solution showed good statistical quality criteria , even after split-half cross-validation .


`` Elderly patients adapted to pain '' ( cluster 1 ) and `` younger patients with acute pain '' ( cluster 4 ) accounted for 55 % of all patients .


Cluster validation showed the lowest direct and indirect costs in these groups .


About 72 % of total costs per patient referred to clusters 2 and 3 ( `` patients with chronic severe pain with comorbid depression '' and `` younger patients with subacute pain and emotional distress '' ) .


Our study adds substantially to the knowledge of LBP-related case-mix in primary care .


Information on differential health care needs may be inferred from our study , enabling decision makers to allocate resources more appropriately and to reduce costs .


Erectile dysfunction ( ED ) has been shown to be associated with a number of physical conditions and affects not only physical but also psychosocial health .


Currently oral , on-demand phosphodiesterase type 5 inhibitors ( PDE5i ) are preferred first line treatment .


Though effective , these drugs have limitations and are associated with significant non-compliance , side effects and do not reverse the underlying pathology .


Non-invasive low intensity shockwave therapy ( LISWT ) has been shown to significantly improve erectile function in men previously PDE5i dependent .


We describe our experience and results with this therapy in an Indian population of men with ED .


This study assessed the efficacy of low intensity extracorporeal shockwave therapy ( LI-ESWT ) on Indian men with organic ED who had previously responded to PDE5i .


All the patients underwent a 1 month PDE5i washout period .


Men were randomized to receive either 12 sessions of LI-ESWT ( n = 95 ) or placebo/sham therapy ( n = 40 ) .


Before the first treatment , erectile function and penile hemodynamics were assessed to substantiate a vascular etiology for the ED .


Outcomes were assessed using Erection Hardness Score ( EHS ) , International Index of Erectile Function-Erectile Function Domain ( IIEF-EF domain ) and Clinical Global Impression of Change ( CGIC ) scores at 1 , 3 , 6 , 9 and 12 months post-treatment .


We found a significant increase in the EHS and IIEF-EF Domain scores from visit 1 to follow up 5 ( 12 months ) in the treated group compared to the placebo group .


By 1 month after treatment there were highly significant differences between the LI-ESWT and placebo groups ( p < 0.0001 ) .


Out of 60 men in the LI-ESWT group who completed the study , 47 ( 78 % ) men at FU1 and 43 ( 71 % ) at FU5 who were initially unable to achieve spontaneous erections hard enough for penetration ( EHS 2 ) were able to do so ( EHS 3 ) compared to none in the placebo group .


The treatment was well tolerated and none of the men experienced treatment related discomfort or reported any adverse effects from the treatment .


In this double-blind , placebo-controlled study , LI-ESWT demonstrated a positive long term clinical effect with improvement in erectile function of Indian men with vasculogenic ED who were prior responders to PDE5i therapy .


The efficacy and tolerability of this treatment , coupled with its long term benefits and rehabilitative characteristics , make it an attractive new therapeutic option for men with vasculogenic erectile dysfunction .


The purpose of this article is to prospectively and directly compare the capabilities of non-contrast-enhanced MR angiography ( MRA ) , 4D contrast-enhanced MRA , and contrast-enhanced MDCT for assessing pulmonary vasculature in patients with non-small cell lung cancer ( NSCLC ) before surgical treatment .


A total of 77 consecutive patients ( 41 men and 36 women ; mean age , 71 years ) with pathologically proven and clinically assessed stage I NSCLC underwent thin-section contrast-enhanced MDCT , non-contrast-enhanced and contrast-enhanced MRA , and surgical treatment .


The capability for anomaly assessment of the three methods was independently evaluated by two reviewers using a 5-point visual scoring system , and final assessment for each patient was made by consensus of the two readers .


Interobserver agreement for pulmonary arterial and venous assessment was evaluated with the kappa statistic .


Then , sensitivity , specificity , and accuracy for the detection of anomalies were directly compared among the three methods by use of the McNemar test .


Interobserver agreement for pulmonary artery and vein assessment was substantial or almost perfect ( = 0.72-0 .86 ) .


For pulmonary arterial and venous variation assessment , there were no significant differences in sensitivity , specificity , and accuracy among non-contrast-enhanced MRA ( pulmonary arteries : sensitivity , 77.1 % ; specificity , 97.4 % ; accuracy , 87.7 % ; pulmonary veins : sensitivity , 50 % ; specificity , 98.5 % ; accuracy , 93.2 % ) , 4D contrast-enhanced MRA ( pulmonary arteries : sensitivity , 77.1 % ; specificity , 97.4 % ; accuracy , 87.7 % ; pulmonary veins : sensitivity , 62.5 % ; specificity , 100.0 % ; accuracy , 95.9 % ) , and thin-section contrast-enhanced MDCT ( pulmonary arteries : sensitivity , 91.4 % ; specificity , 89.5 % ; accuracy , 90.4 % ; pulmonary veins : sensitivity , 50 % ; specificity , 100.0 % ; accuracy , 95.9 % ) ( p > 0.05 ) .


Pulmonary vascular assessment of patients with NSCLC before surgical resection by non-contrast-enhanced MRA can be considered equivalent to that by 4D contrast-enhanced MRA and contrast-enhanced MDCT .


Effective targeted treatment is unavailable for most sarcomas and doxorubicin and ifosfamide-which have been used to treat soft-tissue sarcoma for more than 30 years-still have an important role .


Whether doxorubicin alone or the combination of doxorubicin and ifosfamide should be used routinely is still controversial .


We assessed whether dose intensification of doxorubicin with ifosfamide improves survival of patients with advanced soft-tissue sarcoma compared with doxorubicin alone .


We did this phase 3 randomised controlled trial ( EORTC 62012 ) at 38 hospitals in ten countries .


We included patients with locally advanced , unresectable , or metastatic high-grade soft-tissue sarcoma , age 18-60 years with a WHO performance status of 0 or 1 .


They were randomly assigned ( 1:1 ) by the minimisation method to either doxorubicin ( 75 mg/m ( 2 ) by intravenous bolus on day 1 or 72 h continuous intravenous infusion ) or intensified doxorubicin ( 75 mg/m ( 2 ) ; 25 mg/m ( 2 ) per day , days 1-3 ) plus ifosfamide ( 10 g/m ( 2 ) over 4 days with mesna and pegfilgrastim ) as first-line treatment .


Randomisation was stratified by centre , performance status ( 0 vs 1 ) , age ( < 50 vs 50 years ) , presence of liver metastases , and histopathological grade ( 2 vs 3 ) .


Patients were treated every 3 weeks till progression or unacceptable toxic effects for up to six cycles .


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


The trial is registered with ClinicalTrials.gov , number NCT00061984 .


Between April 30 , 2003 , and May 25 , 2010 , 228 patients were randomly assigned to receive doxorubicin and 227 to receive doxorubicin and ifosfamide .


Median follow-up was 56 months ( IQR 31-77 ) in the doxorubicin only group and 59 months ( 36-72 ) in the combination group .


There was no significant difference in overall survival between groups ( median overall survival 128 months [ 955 % CI 105-143 ] in the doxorubicin group vs 143 months [ 125-165 ] in the doxorubicin and ifosfamide group ; hazard ratio [ HR ] 083 [ 955 % CI 067-103 ] ; stratified log-rank test p = 0076 ) .


Median progression-free survival was significantly higher for the doxorubicin and ifosfamide group ( 74 months [ 95 % CI 66-83 ] ) than for the doxorubicin group ( 46 months [ 29-56 ] ; HR 074 [ 95 % CI 060-090 ] , stratified log-rank test p = 0003 ) .


More patients in the doxorubicin and ifosfamide group than in the doxorubicin group had an overall response ( 60 [ 26 % ] of 227 patients vs 31 [ 14 % ] of 228 ; p < 00006 ) .


The most common grade 3 and 4 toxic effects-which were all more common with doxorubicin and ifosfamide than with doxorubicin alone-were leucopenia ( 97 [ 43 % ] of 224 patients vs 40 [ 18 % ] of 223 patients ) , neutropenia ( 93 [ 42 % ] vs 83 [ 37 % ] ) , febrile neutropenia ( 103 ( 46 % ) vs 30 [ 13 % ] ) , anaemia ( 78 [ 35 % ] vs 10 [ 5 % ] ) , and thrombocytopenia ( 75 [ 33 % ] ) vs one [ < 1 % ] ) .


Our results do not support the use of intensified doxorubicin and ifosfamide for palliation of advanced soft-tissue sarcoma unless the specific goal is tumour shrinkage .


These findings should help individualise the care of patients with this disease .


Cancer Research UK , EORTC Charitable Trust , UK NHS , Canadian Cancer Society Research Institute , Amgen .


To evaluate the relative bioavailability of single pill combination ( SPC ) tablets of linagliptin and metformin compared with separate tablets co-administered in healthy Chinese subjects .


This was an open-label , single-dose , randomized , two-period , crossover study in healthy Chinese subjects with two dose groups : linagliptin 2.5 mg/metformin 850 mg and linagliptin 2.5 mg/metformin 500 mg .


Within each group ( n = 24 ) , subjects received one dose of the SPC tablet in one period and one dose of the separate tablets in the other .


Primary endpoints were area under the plasma concentration-time curve from 0 to 72 hours ( AUC0-72 ) and maximum plasma concentration ( Cmax ) for linagliptin , and AUC from 0 to the last quantifiable concentration ( AUC0-tz ) and Cmax for metformin .


With the linagliptin 2.5 mg/metformin 850 mg dose , the adjusted geometric mean ratio of the SPC to the separate tablets for linagliptin was 99.53 % ( 90 % confidence interval ( CI ) : 94.75-104 .55 ) for AUC0-72 and 101.93 % ( 90 % CI : 95.36-108 .95 ) for Cmax ; for metformin the ratio was 96.99 % ( 90 % CI : 90.62-103 .81 ) for AUC0-tz and 94.64 % ( 90 % CI : 85.43-104 .84 ) for Cmax .


With the linagliptin 2.5 mg/metformin 500 mg dose , the ratio with linagliptin for AUC0-72 and Cmax was 100.81 % ( 90 % CI : 95.14-106 .82 ) and 111.37 % ( 90 % CI : 100.40-123 .54 ) , respectively ; the same statistical parameters with metformin for AUC0-tz and Cmax were 102.95 % ( 90 % CI : 96.24-110 .12 ) and 102.46 % ( 90 % CI : 92.20-113 .87 ) , respectively .


SPC tablets of linagliptin and metformin were bioequivalent to separate tablets co-administered in healthy Chinese subjects .


To examine the effect of intensive glycemic control on cardiovascular disease events ( CVD ) among the major race/ethnic groups in a post-hoc analysis of the VADT .


Participants included 1111 non-Hispanic Whites , 307 Hispanics and 306 non-Hispanic Blacks randomized to intensive or standard glucose treatment in VADT .


Multivariable Cox proportional hazards models were constructed to assess the effect of intensive glucose treatment on CVD events among race/ethnic groups .


Mean age was 60.4 years and median follow-up was 5.6 years .


By design , modifiable risk factors were managed equally well in both treatment arms and only differed modestly between race/ethnic groups .


HbA ( 1c ) decreased significantly from baseline with intensive glucose treatment in each race/ethnic group , with a trend for a greater response in Hispanics ( P = 0.02 for overall comparison between groups ) .


Intensive glucose treatment was associated with reduced risk of CVD events for Hispanics but not for others ( hazard ratios ranged from 0.54 to 0.75 for Hispanics whereas they were consistently close to 1 for others ) .


Sensitivity analyses with different definitions of race/ethnicity or limited to individuals free of previous known CVD yielded similar results .


The results of these analyses support the hypothesis that race/ethnicity is worthy of consideration when tailoring intensive treatment for individuals with long-standing type 2 diabetes .


However , additional studies are needed to confirm the findings of this post-hoc analysis .


Audit and feedback to physicians is a commonly used quality improvement strategy , but its optimal design is unknown .


This trial tested the effects of a theory-informed worksheet to facilitate goal setting and action planning , appended to feedback reports on chronic disease management , compared to feedback reports provided without these worksheets .


A two-arm pragmatic cluster randomized trial was conducted , with allocation at the level of primary care clinics .


Participants were family physicians who contributed data from their electronic medical records .


The ` usual feedback ' arm received feedback every six months for two years regarding the proportion of their patients meeting quality targets for diabetes and/or ischemic heart disease .


The intervention arm received these same reports plus a worksheet designed to facilitate goal setting and action plan development in response to the feedback reports .


Blood pressure ( BP ) and low-density lipoprotein cholesterol ( LDL ) values were compared after two years as the primary outcomes .


Process outcomes measured the proportion of guideline-recommended actions ( e.g. , testing and prescribing ) conducted within the appropriate timeframe .


Intention-to-treat analysis was performed .


Outcomes were similar across groups at baseline .


Final analysis included 20 physicians from seven clinics and 1,832 patients in the intervention arm ( 15 % loss to follow up ) and 29 physicians from seven clinics and 2,223 patients in the usual feedback arm ( 10 % loss to follow up ) .


Ten of 20 physicians completed the worksheet at least once during the study .


Mean BP was 128/72 in the feedback plus worksheet arm and 128/73 in the feedback alone arm , while LDL was 2.1 and 2.0 , respectively .


Thus , no significant differences were observed across groups in the primary outcomes , but mean haemoglobin A1c was lower in the feedback plus worksheet arm ( 7.2 % versus 7.4 % , p < 0.001 ) .


Improvements in both arms were noted over time for one-half of the process outcomes .


Appending a theory-informed goal setting and action planning worksheet to an externally produced audit and feedback intervention did not lead to improvements in patient outcomes .


The results may be explained in part by passive dissemination of the worksheet leading to inadequate engagement with the intervention .


ClinicalTrials.gov NCT00996645 .


The objective of this study was to compare the image quality of a dual-energy nonlinear image blending technique at reduced load of contrast medium with a simulated 120-kVp linear blending technique at a full dose during portal venous phase MDCT of the abdomen .


Forty-five patients ( 25 men , 20 women ; mean age , 65.6 9.7 [ SD ] years ; mean body weight , 74.9 12.4 kg ) underwent contrast-enhanced single-phase dual-energy CT of the abdomen by a random assignment to one of three different contrast medium ( iomeprol 400 ) dose injection protocols : 1.3 , 1.0 , or 0.65 mL/kg of body weight .


The contrast-to-noise ratio ( CNR ) and noise at the portal vein , liver , aorta , and kidney were compared among the different datasets using the ANOVA .


Three readers qualitatively assessed all datasets in a blinded and independent fashion .


Nonlinear blended images at a 25 % reduced dose allowed a significant improvement in CNR ( p < 0.05 for all comparisons ) , compared with simulated 120-kVp linear blended images at a full dose .


No statistically significant difference existed in CNR and noise between the nonlinear blended images at a 50 % reduced dose and the simulated 120-kVp linear blended images at a full dose .


Nonlinear blended images at a 50 % reduced dose were considered in all cases to have acceptable image quality .


The dual-energy nonlinear image blending technique allows reducing the dose of contrast medium up to 50 % during portal venous phase imaging of the abdomen while preserving image quality .


Major liver resection is associated with haemodynamic , hepatic and renal changes as a result of the procedure .


To compare Desflurane ( D ) versus Sevoflurane ( S ) on hepatic , renal functions , haemodynamics and perioperative course for cirrhotic patients undergoing major liver resection .


A prospective randomized control study with 50 patients ( Child A ) ( D , n = 25 and S , n = 25 ) .


End tidal D or S adjusted with Entropy ( 40-60 ) .


Haemodynamics monitored with invasive blood pressure and trans-oesophageal Doppler ( TED ) .


Liver and kidney function tests , blood Glutathione-S-transferase ( GST ) , urinary microalbuminuria ( Microalb ) were assayed .


Extubation time and anaesthetic consumption were recorded .


Systemic vascular resistance ( SVR ) post-resection and stroke volume of D vs S were 835.04 12.02 vs 778.16 11.97 dyn.sec.cm ( -5 ) , P < 0.01 , and 85.72 2.95 vs 76.16 6.52 ml , P < 0.01 respectively .


Doppler corrected flow time ( FTc ) between groups were comparable ( P > 0.05 ) .


No difference post-operatively regarding hepatic and renal functions , and urine Microalb ( 14.76 3.95 vs l4 .24 8.65 g/ml , P = 0.78 ) , but a statistically difference was found with GST ( 0.046 [ symbols : see text ] , vs 0.043 [ symbols : see text ] IU/ml , P < 0.01 ) .


Despite a higher D consumption ( 73 17 vs 64 22 ml , P = 0.102 ) , cost in Egyptian pounds ( LE ) was lower with D ( 141.14 32.90 vs 320.60 114.01 , LE , P < 0.01 ) .


Extubation time and ICU stay with D vS ( 4.52 2 vs 7.72 2 min , P < 0.01 ) and ( 1.40 0.50 vs 1.64 0.48 , days P = 0.09 ) respectively .


Neither D nor S were clinically superior to the other with respect to liver and kidneys functions , but D was found to preserve better the haemodynamic parameters and enhance recovery at a lower cost .


Acute kidney injury ( AKI ) after cardiopulmonary bypass surgery to correct congenital heart disease is common .


We prevent fluid overload and further cardiac compromise in oliguric infants with continuous peritoneal dialysis ( CPD ) .


The effect of CPD on kidney recovery is unknown , thus indications to discontinue CPD are unclear .


We aimed to determine if CPD affects kidney recovery , measured by urine output and novel urinary AKI biomarker concentrations .


Twenty infants < 90 days old with congenital heart disease who underwent bypass surgery and were post-operatively treated with CPD were randomized at the time of clinical readiness for CPD discontinuation to 1 ) discontinue CPD ( control ) or 2 ) continue 24 h more CPD ( experimental ) .


Urine output ( ml/kg per h ) , total output ( ml/kg per h ) and urinary neutrophil gelatinase-associated lipocalin , interleukin-18 , liver-type fatty acid binding protein , and kidney injury molecule-1 were assessed post-surgery until CPD catheter removal .


24 hours preceding randomization , there were no differences in mean urine output or total output ; 24 hours post-randomization , the control group had higher mean urine output ( 4.2 2.6 ml/kg per h vs. 2.8 2.0 ml/kg per h , p = 0.02 ) but lower total output ( 6.3 2.1 ml/kg per h vs. 4.7 2.7 ml/kg per h , p = 0.01 ) .


Median biomarker concentrations did not differ significantly between groups at any time point .


Our results suggest renal replacement therapy does not change the time course of kidney function recovery .


To evaluate the long-term effects of dietary intervention on gastrointestinal symptoms after highly dose-escalated radiotherapy for localized prostate cancer , using boost with protons or high-dose-rate brachytherapy .


Patients were randomized to an intervention group ( n = 64 ) advised to reduce insoluble dietary fiber and lactose intake , or to a standard care group ( n = 66 ) advised to continue their usual diet .


Gastrointestinal symptoms , other domains of health-related quality of life ( HRQOL ) , and dietary intake were evaluated for 24months post-radiotherapy with the European Organization for Research and Treatment of Cancer quality-of-life questionnaires QLQ-C30 and QLQ-PR25 , Gastrointestinal Side Effects Questionnaire , and Food Frequency Questionnaire .


The effect of the intervention on gastrointestinal symptoms was evaluated using generalized estimating equations .


Dietary intervention had no obvious effect on long-term gastrointestinal symptoms or HRQOL .


The intervention group markedly reduced their dietary fiber and lactose intake during radiotherapy , but adherence tended to decline over time .


The vast majority of long-term gastrointestinal symptoms were reported as ' a little ' , with a noticeable difference from pre-treatment only for unintentional stool leakage , limitations on daily activities , and mucus discharge .


Long-term gastrointestinal symptoms were predominantly mild , and dietary intervention was not superior to a usual diet in preventing these symptoms .


Longstanding complex regional pain syndrome ( CRPS ) is refractory to treatment with established analgesic drugs in most cases , and for many patients , alternative pain treatment approaches , such as with neuromodulation devices or rehabilitation methods , also do not work .


The development of novel , effective treatment technologies is , therefore , important .


There are preliminary data suggesting that low-dose immunoglobulin treatment may significantly reduce pain from longstanding CRPS .


LIPS is a multicentre ( United Kingdom ) , double-blind , randomised parallel group , placebo-controlled trial , designed to evaluate the efficacy , safety , and tolerability of intravenous immunoglobulin ( IVIg ) 0.5 g/kg plus standard treatment , versus matched placebo plus standard treatment in 108 patients with longstanding complex regional pain syndrome .


Participants with moderate or severe CRPS of between 1 and 5 years duration will be randomly allocated to receive IVIg 0.5 g/kg ( IntratectTM 50 g/l solution for infusion ) or matching placebo administered day 1 and day 22 after randomisation , followed by two optional doses of open-label medication on day 43 after randomisation and on day 64 after randomisation .


The primary outcome is the patients ' pain intensity in the IVIG group compared with the placebo group , between 6 and 42 days after randomisation .


The primary trial objective is to confirm the efficacy and confidently determine the effect size of the IVIG treatment technology in this group of patients .


ISRCTN42179756 ( Registered 28 June 13 ) .


In vitro fertilisation ( IVF ) treatment provides an opportunity to study early developmental responses to periconceptional dietary interventions .


Retrospective studies have suggested links between preconception diet and fertility , and more recently , a `` Mediterranean '' diet has been reported to increase pregnancy rates by up to 40 % .


In addition , a prospective study examining increased intake of omega-3 polyunsaturated fats demonstrated a quickened rate of embryo development after IVF .


However , up to now , few prospective randomised controlled trials have investigated the impact of periconceptional dietary interventions on fertility outcomes .


The study is a randomised controlled trial of a dietary intervention consisting of olive oil for cooking , an olive oil based spread , and a daily supplement drink enriched with Vitamin D ( 10 microgram daily ) and marine omega-3 fatty acids ( 2g daily ) for 6weeks preconception versus a control diet of sunflower seed oil for cooking , a sunflower oil based spread , and a daily supplement drink without added Vitamin D or marine omega-3 fatty acids .


Couples undergoing IVF will be randomised to either the intervention or control group ( 55 in each arm ) .


The primary endpoint is embryo developmental competency in vitro , measured by validated morphokinetic markers .


Secondary outcomes will include the effect of the dietary intervention on the nutritional content of the intrauterine environment .


This approach will enable rigorous examination of the impact of the dietary intervention on early embryo development , together with the influence of the peri-implantation intra-uterine nutritional environment .


ISRCTN50956936 .


Traditional Chinese acupuncture ( TCA ) is an effective alternative treatment in migraine headache .


The aim of this study was to compare the therapeutic effect of Yamamoto new scalp acupuncture ( YNSA ) , a recently developed microcupuncture system , with TCA for the prophylaxis and treatment of migraine headache .


In a randomized clinical trial , 80 patients with migraine headache were assigned to receive YNSA or TCA .


A pain visual analogue scale ( VAS ) and migraine therapy assessment questionnaire ( MTAQ ) were completed before treatment , after 6 and 18 sections of treatment , and 1 month after completion of therapy .


All the recruited patients completed the study .


Baseline characteristics were similar between the two groups .


Frequency and severity of migraine attacks , nausea , the need for rescue treatment , and work absence rate decreased similarly in both groups .


Recovery from headache and ability to continue daily activities 2 hours after medical treatment showed similar improvement in both groups ( p > 0.05 ) .


Classic acupuncture and YNSA are similarly effective in the prophylaxis and treatment of migraine headache and may be considered as alternatives to pharmacotherapy .


The latest meta-analysis demonstrated that acupuncture improves pregnancy rates among women undergoing in vitro fertilization-embryo transfer ( IVF-ET ) , and surface acupoint stimulation , such as transcutaneous electrical acupoint stimulation ( TEAS ) , may have the same or better potential .


To explore the effect of TEAS on the clinical pregnancy rate ( CPR ) and live birth rate ( LBR ) compared with real acupuncture and controls in women undergoing IVF , a multicenter , randomized controlled trial will be conducted .


The inclusion criteria are the following : infertile women < 40years of age undergoing a fresh IVF or intracytoplasmic sperm injection cycle , and the study will be restricted to women with the potential for a lower success rate as defined by two or more previous unsuccessful ETs ( fresh or frozen ) .


Those who have severe illnesses possibly precluding IVF or pregnancy , have FSH levels greater than 20IU/L , received donor eggs , had been previously randomized for this study or had undergone acupuncture ( in any modality ) as infertility treatment will be excluded .


The subjects will be randomly assigned to the TEAS group ( IVF+TEAS ) , the electro-acupuncture ( EA ) group ( IVF+EA ) , or the control group ( only IVF ) .


A total sample size of 2,220 women is required to detect differences in CPR among the three groups .


TEAS or EA treatments will start once every two or three days from day 3 of menstruation in the ovarian stimulation cycle until the day of ET .


The parameters of TEAS or EA will be the following : a frequency of 2/100Hz , a moderate electrical current of 3 to 5mA for TEAS and 0.8 to 1.0 mA for EA .


The primary outcome is CPR .


Secondary outcomes are LBR , the number of oocytes aspirated and the total gonadotropin dose used in the stimulation cycle .


This study will provide significant evidence for using a new method ( TEAS ) in IVF .


ClinicalTrials.govID : NCT01608048 ( 05/24/2012 ) .


To assess the efficacy of Korean Immigrants and Mammography-Culture-Specific Health Intervention ( KIM-CHI ) , an educational program for Korean American ( KA ) couples designed to improve mammography uptake among KA women .


A two-group cluster randomized , longitudinal , controlled design .


50 KA religious organizations in the Chicago area .


428 married KA women 40 years of age or older who had not had a mammogram in the past year .


The women and their husbands were recruited from 50 KA religious organizations .


Couples were randomly assigned to intervention or attention control groups .


Those in the KIM-CHI program ( n = 211 couples ) were compared to an attention control group ( n = 217 couples ) at baseline , as well as at 6 and 15 months postintervention on mammogram uptake .


Sociodemographic variables and mammography uptake were measured .


Level of acculturation was measured using the Suinn-Lew Asian Self-Identity Acculturation Scale .


Researchers asked questions about healthcare resources and use , health insurance status , usual source of care , physical examinations in the past two years , family history of breast cancer , and history of mammography .


The KIM-CHI group showed statistically significant increases in mammography uptake compared to the attention control group at 6 months and 15 months postintervention .


The culturally targeted KIM-CHI program was effective in increasing mammogram uptake among nonadherent KA women .


Nurses and healthcare providers should consider specific health beliefs as well as inclusion of husbands or significant others .


They also should target education to be culturally relevant for KA women to effectively improve frequency of breast cancer screening .


The authors analyzed headache relief after anterior cervical discectomy .


Headache may be relieved after anterior cervical discectomy , but the mechanism is unknown .


If headaches were directly referred from upper cervical pathology , more headache relief would be expected from surgery performed at higher cervical levels .


If spinal kinesthetics were the mechanism , then headache relief may differ between arthroplasty and fusion .


Headache relief after anterior cervical discectomy was quantified by the operated disc level and by the method of operation ( arthroplasty vs arthrodesis ) .


The authors performed a post hoc analysis of an artificial disc trial .


Data on headache pain were extracted from the Neck Disability Index ( NDI ) questionnaire .


A total of 260 patients underwent single-level arthroplasty or arthodesis .


Preoperatively , 52 % reported NDI headache scores of 3 or greater , compared with only 13 % -17 % postoperatively .


The model-based mean NDI headache score at baseline was 2.5 ( 95 % CI 2.3-2 .7 ) and was reduced by 1.3 points after surgery ( 95 % CI 1.2-1 .4 , p < 0.001 ) .


Higher cervical levels were associated with a greater degree of preoperative headache , but there was no association with headache relief .


There was no significant difference in headache relief between arthroplasty and arthrodesis .


Most patients with symptomatic cervical spondylosis have headache as a preoperative symptom ( 88 % ) .


Anterior cervical discectomy with both arthroplasty and arthrodesis is associated with a durable decrease in headache .


Headache relief is not related to the level of operation .


The mechanism for headache reduction remains unclear .


Mild dysphonia in childhood is surprisingly common , yet moderate to severe dysphonia is rare .


The latter has been associated with complex medical conditions and congenital abnormalities .


Intubation injury has also been documented as a cause of childhood dysphonia .


Children born very preterm may be intubated as part of the intensive care administered in the perinatal and neonatal periods , yet there are few studies investigating dysphonia in this population .


This study will be the first to : use an objective acoustic voice assessment in a paediatric study , document the incidence of dysphonia in very preterm children at school age , and conduct a controlled trial of behavioural voice therapy in this population .


This study will consist of three phases : assessment of voice quality and its impact on quality of life in up to 200 children born at less than 32 weeks ' gestation : assessment of the nature and extent of laryngeal pathology in children with moderate to severe dysphonia ; and a non-blinded , randomised controlled trial of behavioural voice therapy in children with moderate to severe dysphonia .


This study will be the first to use clinical assessment to examine the voice quality of very preterm children , and to use fibre optic endoscopic evaluation of laryngeal function to determine the nature and extent of any laryngeal pathology in such children .


Those participants with significant voice difficulties will be randomised to receive treatment immediately or after the eight week assessment .


This study is registered on the Australian New Zealand Clinical Trials Registry ( ACTRN12613001015730/ACTRN12613001012763 ) .


Male and female condom ( FC ) functional performance failure declines with user experience .


With the recent availability of a wider range of FCs , it is important to know if women with experience in using one type of FC are more proficient in using another type , even if the FC design is quite different .


A randomized , noninferiority crossover clinical trial assessed the function of four FCs ( FC2 , Woman 's Condom , Cupid and VA w.o.w ) among 300 women in Durban , South Africa .


FC functional failure ( breakage , slippage , invagination and misdirection ) by condom type and use period was investigated in women using five FCs of each type ( 20 FC uses in total ) .


Of the 5364 condoms used during intercourse by 272 women , 200 clinical failures occurred in 195 condoms ( 190 condoms had one failure , and 5 had two failures ) .


Total clinical failure was comparable across FC types .


Of the 195 condoms in which failures occurred , the number of failures in the first condom use period was 103 ( 7.7 % ) , decreasing to 43 events ( 3.2 % ) in the second , 33 ( 2.5 % ) in the third and 16 ( 1.2 % ) in the fourth .


Only 2 failures were reported in the 20th use of an FC compared to 29 in the first use , irrespective of condom type .


FC failure rates decreased markedly after use of the first five condoms regardless of FC type and continued to fall across the next three use periods .


FC failure rates decrease over 20 uses , regardless of FC condom type used .


The decrease is higher at the beginning of use , indicating that improvement is greatest after the first five uses .


Etrolizumab is a humanised monoclonal antibody that selectively binds the 7 subunit of the heterodimeric integrins 47 and E7 .


We aimed to assess etrolizumab in patients with moderately-to-severely active ulcerative colitis .


In this double-blind , placebo-controlled , randomised , phase 2 study , patients with moderately-to-severely active ulcerative colitis who had not responded to conventional therapy were recruited from 40 referral centres in 11 countries .


Eligible patients ( aged 18-75 years ; Mayo Clinic Score [ MCS ] of 5 of higher [ or 6 in USA ] ; and disease extending 25 cm or more from anal verge ) were randomised ( 1:1:1 ) to one of two dose levels of subcutaneous etrolizumab ( 100 mg at weeks 0 , 4 , and 8 , with placebo at week 2 ; or 420 mg loading dose [ LD ] at week 0 followed by 300 mg at weeks 2 , 4 , and 8 ) , or matching placebo .


The primary endpoint was clinical remission at week 10 , defined as MCS of 2 or less ( with no individual subscore of > 1 ) , analysed in the modified intention-to-treat population ( mITT ; all randomly assigned patients who had received at least one dose of study drug , had at least one post-baseline disease-activity assessment , and had a centrally read screening endoscopic subscore of 2 ) .


This study is registered with ClinicalTrials.gov , number NCT01336465 .


Between Sept 2 , 2011 , and July 11 , 2012 , 124 patients were randomly assigned , of whom five had a endoscopic subscore of 0 or 1 and were excluded from the mITT population , leaving 39 patients in the etrolizumab 100 mg group , 39 in the etrolizumab 300 mg plus LD group , and 41 in the placebo group for the primary analyses .


No patients in the placebo group had clinical remission at week 10 , compared with eight ( 21 % [ 95 % CI 7-36 ] ) patients in the etrolizumab 100 mg group ( p = 00040 ) and four ( 10 % [ 02-24 ] ) patients in the 300 mg plus LD group ( p = 0048 ) .


Adverse events occurred in 25 ( 61 % ) of 41 patients in the etrolizumab 100 mg group ( five [ 12 % ] of which were regarded as serious ) , 19 ( 48 % ) of 40 patients in the etrolizumab 300 mg plus LD group ( two [ 5 % ] serious ) , and 31 ( 72 % ) of 43 patients in the placebo group ( five [ 12 % ] serious ) .


Etrolizumab was more likely to lead to clinical remission at week 10 than was placebo .


Therefore , blockade of both 47 and E7 might provide a unique therapeutic approach for the treatment of ulcerative colitis , and phase 3 studies have been planned .


Genentech .


Sildenafil ( Viagra , Pfizer ) is being used to treat pulmonary hypertension ( PH ) .


However , there are limited data on the effects of sildenafil on patients with PH after left-sided valvular surgery .


The purpose of this study was to determine the optimal dosage and the effects of sildenafil on prognosis of patients with PH after left-sided valvular surgery .


This randomised controlled trial , double-blind study enrolled patients with PH undergoing left-sided valvular surgery in our hospital from January to December , 2010 .


Ninety patients were enrolled .


And 0.5 mg/kg sildenafil citrate or placebo was administered through nasogastric tubes , the haemodynamics changes in the 0.5 / 1/2/4 hours were assessed .


The sildenafil citrate/placebo was continued to the discharges and the early prognoses of these patients were compared .


Compared with placebo , a 0.5 mg/kg dose of sildenafil significantly reduced the time of mechanical ventilation , stay-in-ICU and hospitalisation duration .


Sildenafil might be beneficial to the early prognosis of patients with PH after left-sided valvular surgery .


Studies suggest that obesity is associated with lower risk of prostate cancer but more aggressive cancers .


As obesity lowers PSA levels , these observations may be influenced by detection bias .


We examined the association between obesity and risk of low - and high-grade prostate cancer in REDUCE , in which biopsies were largely independent of PSA .


The REDUCE study tested dutasteride for prostate cancer risk reduction in men with a PSA of 2.5 to 10.0 ng/mL and a negative biopsy .


Study participants included 6,729 men who underwent at least one on-study biopsy .


The association between baseline body mass index ( BMI < 25 kg/m ( 2 ) normal weight ; 25-29 .9 kg/m ( 2 ) overweight ; and 30 kg/m ( 2 ) obese ) and risk of high-grade ( Gleason 7 ) or low-grade prostate cancer ( Gleason < 7 ) versus no prostate cancer was examined using multinomial logistic regression .


Overall , 1,739 men ( 27 % ) were normal weight , 3,384 ( 53 % ) overweight , and 1,304 ( 20 % ) were obese .


Obesity was associated with lower risk of low-grade prostate cancer in both univariable ( OR , 0.74 ; P = 0.001 ) and multivariable analyses ( OR , 0.79 ; P = 0.01 ) .


In univariable analysis , obesity was not associated with high-grade prostate cancer ( OR , 1.08 ; P = 0.50 ) .


However , in multivariable analysis , obesity was associated with increased risk of high-grade prostate cancer ( OR , 1.28 ; P = 0.042 ) .


This analysis was not able to address how obesity may influence prostate cancer progression .


Obesity is associated with decreased risk of low-grade and increased risk of high-grade prostate cancer .


These data provide further support to the hypothesis that obesity is associated with aggressive prostate cancer .


Obesity is linked with aggressive prostate cancer .


Avoiding obesity may prevent the risk of developing high-grade prostate cancer .


To evaluate the effect of a topical , nonsteroidal antiinflammatory drug , nepafenac 0.1 % , in eyes with noncentral diabetic macular edema .


Multicenter , double-masked randomized trial .


Individuals with good visual acuity and noncentral-involved diabetic macular edema were randomly assigned to nepafenac 0.1 % ( N = 61 ) or placebo ( nepafenac vehicle , N = 64 ) 3 times a day for 12 months .


The primary outcome was mean change in optical coherence tomography retinal volume at 12 months .


Mean baseline retinal volume was 7.8 mm .


At 12 months , in the nepafenac and placebo groups respectively , mean change in retinal volume was -0.03 mm and -0.02 mm ( treatment group difference : -0.02 , 95 % confidence interval : -0.27 to 0.23 , P = 0.89 ) .


Central-involved diabetic macular edema was present in 7 eyes ( 11 % ) and 9 eyes ( 14 % ) at the 12-month visit ( P = 0.79 ) , respectively .


No differences in visual acuity outcomes were identified .


One study participant developed a corneal melt after using nepafenac in the nonstudy eye , which had a history of severe dry eye .


No additional safety concerns were evident .


In eyes with noncentral diabetic macular edema and good visual acuity , topical nepafenac 0.1 % 3 times daily for 1 year likely does not have a meaningful effect on optical coherence tomography-measured retinal thickness .


Menopause predisposes women to sleep-disordered breathing ( SDB ) and sleep disturbances .


Progestin has a potential to stimulate breathing and to induce sleep .


Our goal was to test these effects objectively and to compare them with the effects of nasal continuous positive airway pressure ( CPAP ) , which is the standard treatment of SDB .


In a placebo-controlled , double-blind , parallel-group trial , we investigated 34 postmenopausal women ( 17 in the placebo group and 17 in the medroxyprogesterone acetate [ MPA ] group ) whose SDB had been treated with nasal CPAP for 6 months to 8 years prior to study entry .


The 6-week trial included measurements with CPAP at baseline , after 14 days of placebo or MPA ( 60 mg daily ) , and after a 3-week washout .


The participants discontinued their nasal CPAP therapy 1 week after baseline measurements and went on with study medication .


Two weeks after discontinuation of CPAP therapy , nightly oxygen saturation was sustained higher ( P = 0.004 ) and arterial carbon dioxide tension was lower ( P < 0.001 ) with MPA than with placebo .


Carbon dioxide was also lower than during CPAP ( P < 0.001 ) , and this effect was sustained beyond 3 weeks after the cessation of MPA ( P < 0.001 ) .


However , the apnea-hypopnea index of CPAP increased and sleep deteriorated similarly on MPA and placebo after withdrawal of CPAP therapy .


In postmenopausal women with SDB , MPA induces a long-lasting stimulatory effect on breathing without improving sleep quality or the apnea-hypopnea index .


To evaluate the thermal antinociceptive and sedative effects and duration of action of tramadol hydrochloride after oral administration to American kestrels ( Falco sparverius ) .


12 healthy 3-year-old American kestrels .


Tramadol ( 5 , 15 , and 30 mg/kg ) and a control suspension were administered orally in a masked randomized crossover experimental design .


Foot withdrawal response to a thermal stimulus was determined 1 hour before ( baseline ) and 0.5 , 1.5 , 3 , 6 , and 9 hours after treatment .


Agitation-sedation scores were determined 3 to 5 minutes before each thermal stimulus test .


The lowest dose of tramadol evaluated ( 5 mg/kg ) significantly increased the thermal foot withdrawal thresholds for up to 1.5 hours after administration , compared with control treatment values , and for up to 9 hours after administration , compared with baseline values .


Tramadol at doses of 15 and 30 mg/kg significantly increased thermal thresholds at 0.5 hours after administration , compared with control treatment values , and up to 3 hours after administration , compared with baseline values .


No significant differences in agitation-sedation scores were detected between tramadol and control treatments .


Results indicated oral administration of 5 mg of tramadol/kg significantly increased thermal nociception thresholds for kestrels for 1.5 hours , compared with a control treatment , and 9 hours , compared with baseline values ; higher doses resulted in less pronounced antinociceptive effects .


Additional studies with other types of stimulation , formulations , dosages , routes of administration , and testing times would be needed to fully evaluate the analgesic and adverse effects of tramadol in kestrels and other avian species .


Quantifying lifetime physical activity using self-reported measures is challenging due to reliance on recall , especially in older populations .


The purpose of this study was to determine the 1-year reproducibility of the Veterans Physical Activity Questionnaire ( VAPAQ ) in a cohort of patients with documented abdominal aortic aneurysm disease ( AAA ) .


Subjects included men ( n = 52 ) and women ( n = 3 ) enrolled in AAA STOP , a randomized trial designed to test the ability of supervised exercise training to modify AAA biology and early disease progression .


The overall correlation coefficient for lifetime recreational energy expenditure between the 2 examinations was 0.93 ( P < .001 ) , with an overall difference of 26 kcal/week , a typical error ( standard deviation of the differences ) of 171 kcals/week , and a coefficient of variation ( CV ) of 15.5 % .


The VAPAQ is a reproducible tool to quantify lifetime energy expenditure in older adults with documented vascular disease .


Depression and diabetes cause significant burden for patients and the healthcare system and , when co-occurring , result in poorer self-care behaviors and worse glycemic control than for either condition alone .


However , the clinical management of these comorbid conditions is complicated by a host of patient , provider , and system-level barriers that are especially problematic for patients in rural locations .


Patient-centered medical homes provide an opportunity to integrate mental and physical health care to address the multifaceted needs of complex comorbid conditions .


Presently , there is a need to not only develop robust clinical interventions for complex medically ill patients but also to find feasible ways to embed these interventions into the frontlines of existing primary care practices .


This randomized controlled trial uses a hybrid effectiveness-implementation design to evaluate the Healthy Outcomes through Patient Empowerment ( HOPE ) intervention , which seeks to simultaneously address diabetes and depression for rural veterans in Southeast Texas .


A total of 242 Veterans with uncontrolled diabetes and comorbid symptoms of depression will be recruited and randomized to either the HOPE intervention or to a usual-care arm .


Participants will be evaluated on a host of diabetes and depression-related measures at baseline and 6 - and 12-month follow-up .


The trial has two primary goals : 1 ) to examine the effectiveness of the intervention on both physical ( diabetes ) and emotional health ( depression ) outcomes and 2 ) to simultaneously pilot test a multifaceted implementation strategy designed to increase fidelity and utilization of the intervention by coaches interfacing within the primary care setting .


This ongoing blended effectiveness-implementation design holds the potential to advance the science and practice of caring for complex medically ill patients within the constraints of a busy patient-centered medical home .


Behavioral Activation Therapy for Rural Veterans with Diabetes and Depression : NCT01572389 .


To investigate the efficacy of medical honey as topical treatment of chronically discharging open mastoid cavities in comparison with conventional eardrops .


Single-center , prospective , randomized controlled , double-dose trial of 12 weeks .


Twenty-eight patients diagnosed as having a chronically discharging open mastoid cavity underwent medical honey gel ( intervention ) or conventional eardrops ( control ) treatment .


Treatment interventions were repeated after 4 weeks .


Visual analogue scale of ear complaints , cavity inflammation , and bacterial infection .