Residents in the simulation group obtained significantly higher-quality images with a mean total image quality score of @ ( @ % CI , @ to @ ) versus the control group score of @ ( @ % CI , @ to @ ) ; P = @ .


On average , @ % ( @ % CI , @ to @ ) of images acquired by each resident in the simulator group were acceptable for clinical use compared with @ % ( @ % CI , @ to @ ) in the control ; P = @ .


Additionally , the mean difference in score between training groups was the greatest for the clinical anesthesia-@ residents ( difference @ ; P = @ ; n = @ per group ) and for those with no previous transesophageal echocardiography experience ( difference @ ; P = @ ; simulator n = @ ; control n = @ ) .


Simulation-based transesophageal echocardiography education enhances image acquisition skills in anesthesiology residents .


To describe associations between total and regional body fat mass loss and reduction of systemic levels of inflammation ( C-reactive protein ( CRP ) and interleukin-@ ( IL-@ ) ) in obese , older adults with osteoarthritis ( OA ) , undergoing intentional weight loss .


Data come from a single-blind , @-month , randomized controlled trial in adults ( age : @ @ ; Body mass index ( BMI ) : @ @ ) with knee OA .


Participants were randomized to diet-induced weight loss plus exercise ( D + E ; n = @ ) , diet-induced weight loss-only ( D ; n = @ ) , or exercise-only ( E ; n = @ ) .


Total body and region-specific ( abdomen and thigh ) fat mass were measured at baseline and @ months .


High-sensitivity CRP and IL-@ were measured at baseline , six and @ months .


Intervention effects were assessed using mixed models and associations between inflammation and adiposity were compared using logistic and mixed linear regression models .


Intentional total body fat mass reduction was associated with significant reductions in log-adjusted CRP ( = @ ( @ % CI = @ , @ ) mg/L ) and IL-@ ( = @ ( @ % CI = @ , @ ) pg/mL ) .


Loss of abdominal fat volume was also associated with reduced inflammation , independent of total body fat mass ; although models containing measures of total adiposity yielded the best fit .


The odds of achieving clinically desirable levels of CRP ( < @ mg/L ) and IL-@ ( < @ pg/mL ) were @ ( @ % CI = @ , @ ) and @ ( @ % CI = @ , @ ) , respectively , with @ % total weight and fat mass loss .


Achievement of clinically desirable levels of CRP and IL-@ more than double with intentional @ % loss of total body weight and fat mass .


Global , rather than regional , measures of adiposity are better predictors of change in inflammatory burden .


To explore the effect of cognitive behavioral therapy ( CBT ) in combination with systemic family therapy ( SFT ) on mild to moderate postpartum depression and sleep quality .


@ primiparous women with mild to moderate postpartum depression were recruited and randomly assigned to a control group ( n = @ ) , which received conventional postpartum care , or to a psychological intervention group ( n = @ ) , which received conventional postpartum care combined with psychological intervention .


The Edinburgh Postnatal Depression Scale ( EPDS ) and Pittsburgh Sleep Quality Index ( PSQI ) were employed to evaluate depression and sleep quality , respectively .


@ patients in the intervention group and @ in the control group completed the study .


After intervention , the EPDS score , PSQI score , sleep quality score , sleep latency score , sleep duration score , habitual sleep efficiency score , sleep disturbance score , and daytime dysfunction score were significantly lower in the intervention group than in the control group .


The EPDS and PSQI scores of each group at different time points after intervention were markedly decreased compared with those before intervention , and the reduction in the intervention group was more evident than that in the control group .


CBT in combination with SFT can improve depression and sleep quality in patients with mild to moderate postpartum depression .


Cytomegalovirus ( CMV ) and Epstein-Barr virus ( EBV ) infections are a significant cause of morbidity and mortality in transplant recipients and are often transmitted from the donor organ .


In a pilot prospective , randomized , double-blinded , placebo-controlled trial , we studied whether @ days of pretransplant donor treatment with valganciclovir ( valG ) versus placebo reduced donor-to-recipient transmission , making posttransplant recipient prophylaxis more effective in reducing EBV and CMV disease .


Seventeen D + R - donor-recipient pairs were enrolled : @ and @ donors were randomized to valG and placebo , respectively .


At study initiation , no donor had detectable CMV replication , five had EBV replication ( two in valG , three in placebo group ) : EBV replication was undetectable during valG treatment , but resumed on stopping valG .


Valganciclovir was tolerated without side effects or leukopenia .


All recipients received routine posttransplant viral prophylaxis with valG .


For recipients , viremia-free survival time , incidence , range , peak , and duration of CMV and EBV viremia were not significantly different between groups .


There was no disease in the valG group but two serious viral diseases occurred in the placebo group ( one CMV ; one EBV-related posttransplant lymphoproliferative disorder ) .


In the case of posttransplant lymphoproliferative disorder , the EBV DNA from the donor 's oral wash and the recipient 's lymphoid tissue biopsy had identical latent membrane protein @ ( LMP-@ ) sequence variations from the reference EBV strain , making it highly probable that the recipient 's virus was of donor origin .


Based on this pilot trial , we recommend an adequately powered study to determine if pretransplant donor treatment with valG can reduce posttransplant CMV and EBV disease with merely routine posttransplant recipient viral prophylaxis .


To study the efficacy of traditional Thai massage ( TTM ) versus conventional physical therapy ( PT ) programs in treating muscle spasticity , functional ability , anxiety , depression , and quality of life ( QoL ) in Thai stroke patients .


This randomized controlled trial with a blinded assessor was carried out at the Department of Rehabilitation Medicine , Siriraj Hospital ( Bangkok , Thailand ) .


The study included @ stroke ( onset @ months ) outpatients experiencing spasticity at the elbow or knee muscles at a grade of @ + on the modified Ashworth Scale who were @ years old and able to communicate .


The subjects were randomly allocated to the treatment group receiving TTM ( @ subjects ) or the control group receiving the PT program ( @ subjects ) .


Both groups received treatment ( either TTM or PT ) twice a week for @ weeks .


Spasticity grade , functional ability , anxiety , depression , and QoL were measured at Week @ and Week @ .


At Week @ , the percentage of patients whose modified Ashworth Scale score had decreased by at least one grade was not statistically significant between the two groups .


Both TTM and PT groups experienced a significant increase in functional ability and QoL , but no difference was found between the groups .


Anxiety and depression scores showed a decreasing trend in the TTM group .


This preliminary report showed no evidence that TTM differed from the PT program in decreasing spasticity .


However , both interventions may relieve spasticity , increase functional ability , and improve QoL after @ weeks .


Only TTM can decrease anxiety and depression scores .


Further studies with adequate sample size are necessary .


To investigate the effects of an active and a passive recovery protocol on physiological responses and performance between @ heats in sprint cross-country skiing .


Ten elite male skiers ( @ y , @ cm , @ kg ) undertook @ experimental test sessions that both consisted of @ heats with @ min between start of the first and second heats .


The heats were conducted as an @-m time trial ( @ , > @ m/s , ~ @ s ) and included measurements of oxygen uptake ( VO@ ) and accumulated oxygen deficit .


The active recovery trial involved @ min standing/walking , @ min jogging ( @ % @ % of VO@peak ) , and @ min standing/walking .


The passive recovery trial involved @ min sitting , @ min walk/jog ( ~ @ % of VO@peak ) , and @ min standing/walking .


Blood lactate concentration and heart rate were monitored throughout the recovery periods .


The increased @-m time between heat @ and heat @ was trivial after active recovery ( effect size -LSB- ES -RSB- = @ , P = @ ) and small after passive recovery ( ES = @ , P = @ ) .


The @ % @ % ( mean@ % CL ) difference between protocols was not significant ( ES = @ , P = @ ) .


In heat @ , peak and average VO@ was increased after the active recovery protocol .


Neither passive recovery nor running at ~ @ % of VO@peak between @ heats changed performance significantly .


To examine the role of acupuncture in the treatment of diabetic painful neuropathy ( DPN ) using a single-blind , placebo-controlled RCT and to collect data that would be required in a future definitive study of the efficacy of acupuncture in DPN .


@ patients were allocated to receive a @-week course either of real ( @ % ) or sham ( @ % ) acupuncture .


Five standardised acupuncture points on the lower limb of each leg were used in the study : LR@ , KI@ , SP@ , SP@ and ST@ .


Outcome measures included the Leeds Assessment of Neuropathic Symptoms and Signs ( LANSS ) scale , lower limb pain ( Visual Analogue Scale , VAS ) ; Sleep Problem Scale ( SPS ) ; Measure Yourself Medical Outcome Profile ( MYMOP ) ; @-item Short Form @ Health Survey and resting blood pressure ( BP ) .


Over the @-week treatment period , small improvements were seen in VAS -@ ( -@ to -@ ) , MYMOP -@ ( -@ to -@ ) , SPS -@ ( -@ to -@ ) and resting diastolic BP -@ ( -@ to -@ ) in the true acupuncture group .


In contrast , there was little change in those receiving sham acupuncture .


A moderate treatment effect in favour of active acupuncture was detected in MYMOP scores -@ ( -@ to -@ ) but non-significant effect sizes in LANSS Pain Scale -@ ( -@ to @ ) , resting diastolic BP -@ ( -@ to @ ) and the SPS -@ ( -@ to @ ) .


We have demonstrated the practicality and feasibility of acupuncture as an additional treatment for people with DPN .


The treatment was well tolerated with no appreciable side effects .


Larger randomised trials are needed to confirm the clinical and cost-effectiveness of acupuncture in the treatment of DPN .


Hyaluronic acid ( HA ) fillers and poly-L-lactic acid ( PLA ) fillers are frequently used to correct facial wrinkles .


To compare the efficacy and safety of a novel injectable poly-L-lactic acid ( PLA ) filler and a well-studied biphasic HA filler for the treatment of moderate to severe nasolabial folds .


In this multicentre , randomized , evaluator-blinded , comparative study , subjects were randomized for injections with PLA or HA into both nasolabial folds .


Efficacy was determined by calculating the change in Wrinkle Severity Rating Scale ( WSRS ) relative to baseline .


Local safety was assessed by reported adverse events .


At week @ , mean improvement in WSRS from baseline was @ @ for the PLA side and @ @ for the HA side .


Both injections were well tolerated , and the adverse reactions were mild and transient in most cases .


PLA provides noninferior efficacy compared with HA @ months after being used to treat moderate to severe nasolabial folds .


To explore , using MRI , the disease-modifying effect of strontium ranelate ( SrRan ) treatment on cartilage volume loss ( CVL ) and bone marrow lesions ( BMLs ) in a subset of patients from a Phase III clinical trial in knee osteoarthritis ( OA ) ( SrRan Efficacy in Knee OsteoarthrItis triAl ( SEKOIA ) ) .


Patients with primary symptomatic knee OA were randomised to receive either SrRan @g/day or @g/day or placebo ( SEKOIA study ) .


A subset of these patients had MRIs at baseline , @ , @ and @months to assess the knee cartilage volume and BMLs .


Missing values were imputed and the analyses were adjusted according to Bonferroni .


In this MRI subset , the distribution of patients ( modified intention-to-treat ; n = @ ) was @ , @ and @ for SrRan @g/day , @g/day and placebo , respectively .


The groups were fairly balanced at baseline regarding demographics , clinical symptoms or imaging characteristics .


Treatment with SrRan @g/day significantly decreased CVL on the plateaus at @ ( p = @ ) and @ ( p = @ ) months compared with placebo .


Of note , in the medial femur and plateau , SrRan @g/day , but not SrRan @g/day , had more CVL than placebo .


In patients with BML in the medial compartment at baseline , the BML score at @months was decreased in both treatment groups compared with the placebo group ( SrRan @g/day , p = @ and SrRan @g/day p = @ , respectively ) , and CVL significantly decreased with SrRan @g/day ( p = @ ) in the plateau compared with placebo .


In knee OA patients , treatment with SrRan @g/day was found to have beneficial effects on structural changes by significantly reducing CVL in the plateau and BML progression in the medial compartment .


Relative adrenal insufficiency ( RAI ) has been reported as a predictor of mortality in septic patient ; however , its effects on mortality and outcomes for critically ill patients remain debatable .


The objective of this study was to assess the effect of RAI on prognostic outcomes in patients after out-of-hospital rapid sequence intubation ( RSI ) and factors associated with the onset of RAI .


A prespecified ancillary study of KETASED , a randomized prospective multicenter trial , was conducted .


Three hundred ten patients who underwent RSI in an out-of-hospital setting had baseline cortisol and adrenocorticotropic hormone response test measurements within @ hours of intensive care unit admission and were included .


The mean ( SD ) age was @ ( @ ) years , with a mean ( SD ) Sequential Organ Failure Assessment score of @ ( @ ) .


Two hundred forty-seven ( @ % ) patients presented with RAI .


Baseline characteristics were similar between patients with and without RAI , except for the use of etomidate as a sedative agent ( @ % of patients with RAI vs @ % , P < @ ) , and history of chronic kidney disease .


There was no difference in terms of @-day mortality between the @ groups ( @ % vs @ % , P = @ ) and in terms of other @-day prognosis end points .


In critically ill patients who require RSI , RAI is common and is not associated with worsened outcomes in our cohort .


The aim of the present study was to evaluate the effect of Erythrinamu lungu on the control of dental anxiety in patients who had under gone bilateral extraction of asymptomatic , impacted mandibular third molars .


In a randomized , double-blind , crossover study , @ healthy volunteers ( @ men and @ women , over @ years of age ) , received either @mg of E.mulungu ( MulunguMatusa ) or @ mg of placebo , p.o. , one hour before surgical procedure .


The level ofanxiety was assessed through questionnaire sand physical parameters , such as blood pressure , heart rate andoxygen saturation .


Data were analyzed by Chi-square test , ANOVA ( Tukey test ) and Friedman with significance level of @ % .


A higher preference ( Chi-square , p = @ ) for E. mulungu was observed for both genders .


Volunteers with higher anxiety levels tended to to prefer E. mulungu .


No statistically significant differences were verified in blood pressure ( one-way ANOVA , p = @ ) , heart rate ( Friedman , p > @ ) and oxygen saturation ( Friedman , p = @ ) among periods and types of treatments .


E. mulungu showed an anxiolytic effect without significant changes in physiological parameters .


It could be considered as an alternative to control the anxiety in adult patients undergoing mandibular thirdmolars surgery .


It is well recognized that low-density lipoprotein cholesterol ( LDL-C ) - lowering therapy is effective for primary and secondary prevention of cerebrovascular/cardiovascular disease .


Ezetimibe , an inhibitor of the Niemann-Pick C@-Like @ cholesterol transporter , is a relatively new drug for LDL-C-lowering therapy in addition to statins .


However , comparison between an aggressive LDL-C-lowering therapy with a combination of statin and ezetimibe versus a standard LDL-C-lowering therapy with statin alone is still unclear in terms of their effects on stabilization and volume regression of coronary plaque .


The ZIPANGU ( Ezetimibe clinical investigation for the regression of intracoronary plaque evaluated by angioscopy and ultrasound ) study is aimed at comparing these two types of therapy based on indices of plaque characteristics using non-obstructive coronary angioscopy and intravascular ultrasound .


The study is a multi-center , prospective , randomized , open-label , blinded-endpoint trial .


Through a centralized enrollment method , patients will be allocated to either monotherapy with atorvastatin alone or to combination therapy with atorvastatin ( maximum : @mg/day ) and ezetimibe ( @mg/day ) .


The target LDL-C level will be < @mg/dL for the monotherapy group and < @mg/dL for the combination therapy group .


At the baseline and the follow-up period of @ months , non-obstructive coronary angioscopy and intravascular ultrasound will be performed to compare the changes in plaque color and volume between the two groups .


The ZIPANGU study will clarify whether combination therapy with statins and ezetimibe is better for stabilizing coronary plaque as secondary prevention than monotherapy by statins alone .


The study will give new insights into lipid-lowering guidelines in Japan .


BK virus reactivation in kidney transplant recipients can lead to progressive allograft injury .


Reduction of immunosuppression remains the cornerstone of treatment for active BK infection .


Fluoroquinolone antibiotics are known to have in vitro antiviral properties , but the evidence for their use in patients with BK viremia is inconclusive .


The objective of the study was to determine the efficacy of levofloxacin in the treatment of BK viremia .


Enrollment in this prospective , multicenter , double-blinded , placebo-controlled trial occurred from July @ to March @ .


Thirty-nine kidney transplant recipients with BK viremia were randomly assigned to receive levofloxacin , @ mg daily , or placebo for @ days .


Immunosuppression in all patients was adjusted on the basis of standard clinical practices at each institution .


Plasma BK viral load and serum creatinine were measured monthly for @ months and at @ months .


At the @-month follow-up , the percentage reductions in BK viral load were @ % and @ % in the levofloxacin group and the placebo group , respectively ( P = @ ) .


The percentage reductions in BK viral load were also equivalent at @ month ( @ % versus and @ % ; P = @ ) and @ months ( @ % versus @ % ; P = @ ) .


Linear regression analysis of serum creatinine versus time showed no difference in allograft function between the two study groups during the follow-up period .


A @-day course of levofloxacin does not significantly improve BK viral load reduction or allograft function when used in addition to overall reduction of immunosuppression .


The aim of the study was to determine whether infliximab use and other potential predictors are associated with decreased prevalence and severity of depression in pediatric patients with Crohn disease ( CD ) .


A total of @ ( n = @ ) youth ages @ to @ years with biopsy-confirmed CD were consecutively recruited as part of a multicenter randomized controlled trial .


Out of the @ , @ patients met study criteria and were included in the analysis .


At recruitment , each subject and a parent completed the Children 's Depression Inventory ( CDI ) .


A child or parent CDI score @ was used to denote clinically significant depressive symptoms ( CSDS ) .


Child and parent CDI scores were summed to form total CDI ( CDIT ) .


Infliximab use , demographic information , steroid use , laboratory values , and Pediatric Crohn 's Disease Activity Index ( PCDAI ) were collected as the potential predictors of depression .


Univariate regression models were constructed to determine the relations among predictors , CSDS , and CDIT .


Stepwise multivariate regression models were constructed to predict the relation between infliximab use and depression while controlling for other predictors of depression .


Infliximab use was not associated with a decreased proportion of CSDS and CDIT after adjusting for multiple comparisons .


CSDS and CDIT were positively associated with PCDAI , erythrocyte sedimentation rate , and steroid dose ( P < @ ) and negatively associated with socioeconomic status ( SES ) ( P < @ ) .


In multivariate models , PCDAI and SES were the strongest predictors of depression .


Disease activity and SES are significant predictors of depression in youth with Crohn disease .


To compare curative effect between complete denture with lingualized occlusion and anatomic occlusion on temporomandibular joint disorders ( TMD ) of aged edentulous patients with severe residual alveolar ridge resorption .


Seventy aged edentulous patients with severe residual alveolar ridge resorption were recruited in this study and randomly assigned into two groups , thirty-five each .


In Group A , patients received complete denture with lingualized occlusion , and in Group B , patients received complete denture with anatomic occlusion .


The condition of TMD was examined and recorded by the same TMD specialist at baseline , @ months and @ months following denture delivery .


The recovery effect of TMD was evaluated according to Fricton Index .


Related data were analyzed statistically with t-test and rank sum test .


Three months following denture delivery , the craniomandibular index ( CMI ) decrease value was ( @ @ ) in group A , and was significantly higher than that in group B ( @ @ ) ( P < @ ) .


Six months following denture delivery , the CMI decrease value was ( @ @ ) in group A , and was significantly higher than that in group B ( @ @ ) ( P = @ < @ ) .


Complete denture with lingualized occlusion may be more conducive to the remission of TMD for aged edentulous patients with severe residual alveolar ridge resorption .


To describe the design of the study aiming to examine intensive targeted cognitive rehabilitation of attention in the acute ( < @months ) and subacute rehabilitation phases ( @-@ months ) after acquired brain injury and to evaluate the effects on function , activity and participation ( return to work ) .


Within a prospective , randomised , controlled study @ consecutive patients with stroke or traumatic brain injury were randomised to @ hours of intensive attention training by Attention Process Training or by standard , activity based training .


Progress was evaluated by Statistical Process Control and by pre and post measurement of functional and activity levels .


Return to work was also evaluated in the post-acute phase .


Primary endpoints were the changes in the attention measure , Paced Auditory Serial Addition Test and changes in work ability .


Secondary endpoints included measurement of cognitive functions , activity and work return .


There were @ , @ and @-month follow ups focussing on health economics .


The study will provide information on rehabilitation of attention in the early phases after ABI ; effects on function , activity and return to work .


Further , the application of Statistical Process Control might enable closer investigation of the cognitive changes after acquired brain injury and demonstrate the usefulness of process measures in rehabilitation .


The study was registered at ClinicalTrials.gov Protocol .


Non-dependent alcohol and substance use patterns are prevalent among men who have sex with men ( MSM ) , yet few effective interventions to reduce their substance use are available for these men .


We evaluated whether an adapted brief counseling intervention aimed at reducing HIV risk behavior was associated with secondary benefits of reducing substance use among episodic substance-using MSM ( SUMSM ) .


@ episodic SUMSM were randomized to brief Personalized Cognitive Counseling ( PCC ) intervention with rapid HIV testing or to rapid HIV testing only control .


Both arms followed over @ months .


Trends in substance use were examined using GEE Poisson models with robust standard errors by arm .


Reductions in frequency of use were examined using ordered logistic regression .


In intent-to-treat analyses , compared to men who received rapid HIV testing only , we found men randomized to PCC with rapid HIV testing were more likely to report abstaining from alcohol consumption ( RR = @ ; @ % CI = @-@ @ ) , marijuana use ( RR = @ ; @ % CI = @-@ @ ) , and erectile dysfunction drug use ( EDD ; RR = @ ; @ % CI = @-@ @ ) over the @-month follow-up .


PCC was also significantly associated with reductions in frequency of alcohol intoxication ( OR = @ ; @ % CI = @-@ @ ) over follow-up .


Furthermore , we found PCC was associated with significant reductions in number of unprotected anal intercourse events while under the influence of methamphetamine ( RR = @ ; @ % CI = @-@ @ ) .


The addition of adapted PCC to rapid HIV testing may have benefits in increasing abstinence from certain classes of substances previously associated with HIV risk , including alcohol and EDD ; and reducing alcohol intoxication frequency and high-risk sexual behaviors concurrent with methamphetamine use .


To assess the effect of overnight insulin pump suspension in an automated predictive low glucose suspend system on morning blood glucose and ketone levels in an attempt to determine whether routine measurement of ketone levels is useful when a closed-loop system that suspends insulin delivery overnight is being used .


Data from an in-home randomized trial of @ individuals with type @ diabetes ( age range @-@ years ) were analyzed , evaluating an automated predictive low glucose pump suspension system in which blood glucose , blood ketone , and urine ketone levels were measured on @,@ mornings .


One or more pump suspensions occurred during @ of the @ intervention nights ( @ % ) .


The morning blood ketone level was @ mmol/L after @ of the @ nights ( @ % ) during which a pump suspension occurred and @ of the @ nights ( @ % ) during which there was no suspension compared with @ of @ control nights ( @ % ) .


The morning blood ketone level was @ mmol/L after only @ of @ nights ( @ % ) with a pump suspension exceeding @ h. Morning fasting blood glucose level was not a good predictor of the presence of blood ketones .


Routine measurement of blood or urine ketones during use of an automated pump suspension system using continuous glucose monitoring , whether threshold based or predictive , is not necessary .


Recommendations for checking ketone levels should be no different when a patient is using a system with automated insulin suspension than it is for conventional diabetes self-management .


This randomised double-blind placebo-controlled study evaluated the addition of cediranib , an inhibitor of vascular endothelial growth factor receptors @-@ , to standard carboplatin/paclitaxel chemotherapy in advanced non-small cell lung cancer .


Eligible patients received paclitaxel ( @mg/m ( @ ) ) and carboplatin ( area under the concentration time curve @ ) intravenously every @ weeks .


Daily oral cediranib/placebo @mg was commenced day @ of cycle @ and continued as monotherapy after completion of @-@ cycles of chemotherapy .


The primary end-point of the study was overall survival ( OS ) .


The trial would continue to full accrual if an interim analysis ( IA ) for progression-free survival ( PFS ) , performed after @ events of progression or death in the first @ randomised patients , revealed a hazard ratio ( HR ) for PFS of @ .


The trial was halted for futility at the IA ( HR for PFS @ , @ % confidence interval -LSB- CI -RSB- @-@ @ , p = @ ) .


A final analysis was performed on all @ enrolled patients .


The addition of cediranib increased response rate ( -LSB- RR -RSB- @ % versus @ % , p = @ ) but did not significantly improve PFS ( HR @ , @ % CI @-@ @ , p = @ ) or OS ( HR @ , @ % CI @-@ @ , p = @ ) .


Cediranib patients had more grade @ hypertension , diarrhoea and anorexia .


The addition of cediranib @mg daily to carboplatin/paclitaxel chemotherapy increased RR and toxicity , but not survival .


Physical activity interventions designed for Latinas have shown short-term behavior change , but longer-term change and maintenance is rarely measured .


To assess physical activity change at @ months , following @-month tapered completion of an RCT of a physical activity intervention for Latinas .


Two hundred sixty-six underactive ( < @ minutes/week physical activity ) Latinas were randomized to an individually tailored , culturally and linguistically adapted physical activity intervention , or a wellness contact control .


Participants received the materials through the mail for @ months , then received booster doses at @ , @ , and @ months .


Minutes per week of moderate to vigorous physical activity were measured by the @-Day Physical Activity Recall interview at baseline and @ and @ months .


Data were collected at Brown University between @ and @ , and analyses were conducted in @ .


At @ months , increases in moderate to vigorous physical activity were significantly greater in the intervention than in the wellness group ( mean difference = @ minutes/week , SE = @ , p < @ ) , with both groups showing slight increases in moderate to vigorous physical activity from @ to @ months .


Intervention participants were also more likely to meet national moderate to vigorous physical activity guidelines ( OR = @ , p = @ ) .


The intervention was more effective than the wellness control at @ months , and physical activity increases from baseline to @ months were maintained , suggesting the intervention may lead to sustainable behavior change .


To identify the preoperative characteristics and compare operative variables and postoperative outcomes in adult patients with pectus excavatum undergoing thoracoscopic repair using different bar stabilizers or open surgical repair .


@ patients were randomly divided into @ groups : group A was @ patients who underwent a modified Ravitch repair , group B was @ patients who underwent video-assisted thoracoscopic repair using metal stabilizers , and group C was @ patients who underwent video-assisted thoracoscopic repair using absorbable stabilizers .


Preoperative , intraoperative , and postoperative variables and mortality were compared among groups .


In all groups , preoperative variables were well-matched for age , sex , and Haller index .


Operative time was significantly longer in group A.


The postoperative length of hospital stay was significantly shorter in group A. Postoperative complications occurred in @ ( @ % ) patients , mostly in groups B and C. All patients were satisfied with the cosmetic result .


Repair of pectus excavatum in adult patients can be performed effectively either through an open surgical technique or thoracoscopy , with no intraoperative complications and excellent immediate results , but video-assisted thoracoscopic repair using metallic or absorbable bar stabilizers gives a better cosmetic result ; however , absorbable bar stabilizers are more vulnerable and break more easily than metal stabilizers .


A sildenafil tablet formulation as a PDE-@ inhibitor is widely used for the treatment of erectile dysfunction .


Recently , a fine granular formulation of sildenafil was developed by a domestic Korean pharmaceutical company .


This study was performed to compare the bioavailability of sildenafil fine granules with that of sildenafil tablets for assessing bioequivalence in @ healthy male volunteers .


This was an open-label , randomized sequence , single-dose , two-period , and two-treatment crossover study .


Half of the volunteers received a single dose of sildenafil fine granule @ mg and then sildenafil tablet @ mg after a @-day washout period .


The remaining half of volunteers received the tablet first and the the granule with the same washout period .


@ - mL blood samples were serially sampled to measure the concentrations of sildenafil and the N-desmethyl metabolite .


Tolerability was assessed during the study .


The pharmacokinetic parameters of sildenafil were similar between granular and tablet formulations .


The @ % CI of geometric mean ratios ( sildenafil granule/tablet ) for the pharmacokinetic parameters of sildenafil were within @ @ , as a bioequivalent acceptable range ; @ ( @ % CI , @ - @ ) for maximum plasma concentration ( Cmax ) and @ ( @ - @ ) for area under the concentration - time curve from time zero to time of last measurable concentration ( AUClast ) .


Also , the @ % CI of geometric mean ratios for Cmax and AUClast of the metabolite were within @ - @ .


Both formulations were well tolerated by volunteers .


This study confirmed that sildenafil granules and sildenafil tablet are bioequivalent with regards to pharmacokinetics of sildenafil and N-desmethyl sildenafil .


The epidemics of food insecurity , malnutrition , and human immunodeficiency virus ( HIV ) frequently overlap .


HIV treatment programs increasingly provide nutrient-dense ready-to-use supplementary foods ( RUSFs ) to patients living with HIV and food insecurity , but in the absence of wasting , it is not known if RUSF confers benefit above less costly food commodities .


We performed a randomized trial in rural Haiti comparing an RUSF with less costly corn-soy blend plus ( CSB + ) as a monthly supplement to patients with HIV infection who were on antiretroviral therapy ( ART ) < @ months prior to study start .


We compared @ - and @-month outcomes by ration type in terms of immunologic response , body mass index ( BMI ) , adherence to ART , general health quality of life , household food insecurity , and household wealth .


A cohort of @ patients with HIV receiving ART was randomized and followed over time .


Median CD@ cell count at baseline was @ cells/L ( interquartile range -LSB- IQR -RSB- , @-@ cells/L ) for the CSB + group , and @ cells/L ( IQR , @-@ / L ) for the RUSF group .


Measured outcomes improved from baseline over time , but there were no statistically significant differences in change for BMI , household wealth index , hunger , general health perception score , or adherence to ART by ration type at @ or @ months .


The RUSF group had higher CD@ count at @ months , but this was also not statistically significant .


In @ months of follow-up , there was no statistically significant difference in outcomes between those receiving RUSF-based compared with CSB + - based rations in a cohort of HIV-infected adults on ART in rural Haiti .


To study if low dose Unfractionated heparin ( UFH ) is as effective and safe as Low-molecular weight heparin ( LMWH ) and also economical as a prophylactic agent for venous thromboembolism in medically ill patients .


A prospective double blind randomised controlled trial consisting of @ patients fulfilling the inclusion criteria who were admitted to Bangalore Baptist Hospital , Bengaluru , between March @ and July @ were randomised to receive Unfractionated heparin ( UFH ) or Low-molecular weight heparin ( LMWH ) .


The result based on intention to treat ( ITT ) analysis with best outcome scenario : in the UFH arm there were @ ( @ % ) patients who had not developed DVT/PE as compared to @ ( @ % ) in the LMWH arm .


The difference in proportion of patients who had not developed DVT/PE between UFH and LMWH was @ % ( -@ , @ ) .


The results based on per protocol analysis : In the UFH arm there were @ ( @ % ) patients who had not developed DVT/PE as compared to @ ( @ % ) in the LMWH arm .


The difference in proportion of patients who had not developed DVT/PE between the UFH and LMWH arm was @ % ( -@ , @ ) .


Patients on UFH had higher major bleeding complications @ ( @ % ) as compared to @ in LMWH arm .


But with respect to other complications like thrombocytopenia ( HIT ) and mild or minimal bleeding both arms were comparable .


This study has demonstrated that low dose UFH is as effective as LMWH as a prophylactic agent for venous thromboembolism in medically ill patients and economical also .


Previous studies have shown that treatment with ergocalciferol in patients with CKD stage @ + @ is not effective with less than @ % of patients achieving a @-OH vitamin D target of > @ ng/ml .


The aim of this study was to test the response to cholecalciferol in CKD .


We attempted to replete @-OH vitamin D to a target level of @-@ ng/ml using the response to treatment and PTH suppression as an outcome measure .


This retrospective cohort study identified patients ( Stages @-@ and Transplant ) from @-@ who registered at the Chronic Kidney Disease Clinic .


Patients received cholecalciferol @,@ IU capsules weekly as initial therapy .


When levels above @ ng/ml were not achieved , doses were titrated up to a maximum of @,@ IU weekly .


Active vitamin D analogs were also used in some Stage @-@ CKD patients per practice guidelines .


Patients reaching at least one level of @ ng/mL were designated RESPONDER , and if no level above @ ng/mL they were designated NON-RESPONDER .


Patients were followed for at least @ months and up to @ years .


@ patients were included with a mean follow up of @ years .


Of the CKD patients , the initial @-OH vitamin D in the NON-RESPONDER group was lower than the RESPONDER group ( @ vs. @ ng/ml ) ( p = @ ) .


Among all patients , the initial eGFR in the RESPONDER group was significantly higher than the NON-RESPONDER group ( @ vs. @ ml/min/@ @ m@ ) ( p < @ ) .


Over time , the eGFR of the RESPONDER group stabilized or increased ( p < @ ) .


Over time , the eGFR in the NON-RESPONDER group decreased toward a trajectory of ESRD .


Proteinuria did not impact the response to @-OH vitamin D replacement therapy .


There were no identifiable variables associated with the response or lack of response to cholecalciferol treatment .


CKD patients treated with cholecalciferol experience treatment resistance in raising vitamin D levels to a pre-selected target level .


The mechanism of vitamin D resistance remains unknown and is associated with progressive loss of eGFR .


Proteinuria modifies but does not account for the vitamin D resistance .


The clinical outcomes for patients with worsening chronic heart failure ( WCHF ) remain exceedingly poor despite contemporary evidence-based therapies , and effective therapies are urgently needed .


Accumulating evidence supports augmentation of cyclic guanosine monophosphate ( cGMP ) signalling as a potential therapeutic strategy for HF with reduced or preserved ejection fraction ( HFrEF and HFpEF , respectively ) .


Direct soluble guanylate cyclase ( sGC ) stimulators target reduced cGMP generation due to insufficient sGC stimulation and represent a promising method for cGMP enhancement .


The phase II SOluble guanylate Cyclase stimulatoR in heArT failurE Study ( SOCRATES ) programme consists of two randomized , parallel-group , placebo-controlled , double-blind , multicentre studies , SOCRATES-REDUCED ( in patients with LVEF < @ % ) and SOCRATES-PRESERVED ( in those with LVEF @ % ) , that will explore the pharmacodynamic effects , safety and tolerability , and pharmacokinetics of four dose regimens of the once-daily oral sGC stimulator vericiguat ( BAY @ ) over @ weeks compared with placebo .


These studies will enrol patients stabilized during hospitalization for HF at the time of discharge or within @ weeks thereafter .


The primary endpoint in SOCRATES-REDUCED is change in NT-proBNP at @ weeks .


The primary endpoints in SOCRATES-PRESERVED are change in NT-proBNP and left atrial volume at @ weeks .


SOCRATES will be the first programme to enrol specifically both inpatients and outpatients with WCHF and patients with reduced or preserved ejection fraction .


Results will inform the benefits of pursuing subsequent event-driven clinical outcome trials with sGC stimulators in this patient population .


Tranversus-abdominis plane ( TAP ) block is a novel technique alternative to central neural blockade in providing analgesia to the anterior abdominal wall .


As such , we compared the analgesic efficacy of TAP block with low thoracic-epidural analgesia ( TEA ) in ischemic heart disease patients after abdominal laparotomy .


Forty-four American Society of Anesthesiologists physical status ( ASA ) III patients , @-@ years of age and undergoing elective upper abdominal surgery under general anesthesia , were assigned randomly to receive either continuous low TEA or intermittent administration of local anesthetic in TAP block .


Supplemental analgesia was provided with intravenous morphine with patient-controlled-analgesia .


Morphine consumption and pain intensity using verbal rating scale ( VRS ) at rest and coughing over the first @ h were recorded .


Whereas all patients in the TAP group required morphine , @ ( @ % ) patients in TEA group received morphine postoperatively ( p = @ ) .


Morphine consumed on day @ and day @ was @ mg ( @-@ @ mg ) and @ mg ( @-@ mg ) for the TEA group , while in the TAP group , it was @ mg ( @-@ mg ) and @ mg ( @-@ mg ) , respectively ( p < @ ) .


Time for first request of morphine was @ @ min in the TEA group versus @ @ min in the TAP group ( p < @ ) .


VRS at rest and cough were lower in the TEA group compared with the TAP group at @ , @ , @ , @ , @ , @ and @ h ( p < @ ) .


Incidence of hypotension and ephedrine administration were significantly higher in the TEA group than in the TAP group ( p = @ ) .


Low TEA reduced morphine consumption and provided a higher analgesic efficacy compared with TAP block after laparotomy in ischemic heart disease patients .


Bronchiolitis is one of the most common and costly respiratory diseases in infants and young children .


Previous studies have shown a potential benefit of nebulized hypertonic saline ; however , its effect in the emergency department ( ED ) setting is unclear .


To compare the effect of nebulized @ % hypertonic saline vs @ % normal saline on admission rate and length of stay in infants with bronchiolitis .


We conducted a double-blind , randomized clinical trial during @ consecutive bronchiolitis seasons from March @ , @ , through April @ , @ .


We recruited a convenience sample of patients younger than @ months with a primary diagnosis of viral bronchiolitis presenting to the ED of @ urban free-standing tertiary children 's hospitals .


We excluded patients who were premature ( gestational age , < @ weeks ) or who had chronic pulmonary disease , immune deficiency , cardiac disease , or previous episodes of wheezing or inhaled bronchodilator use .


Of eligible patients who were approached , @ ( @ % ) declined to participate .


Patients received @ mL of @ % sodium chloride ( hypertonic saline -LSB- HS group -RSB- ) or @ % sodium chloride ( normal saline -LSB- NS group -RSB- ) inhaled as many as @ times in the ED .


Those admitted received the assigned medication every @ hours until discharge .


All treatment solutions were premedicated with albuterol sulfate .


Hospital admission rate , length of stay for admitted patients , and Respiratory Distress Assessment Instrument score .


A total of @ patients were enrolled in the NS group and @ in the HS group .


Admission rate in the @ % HS group was @ % compared with @ % in the NS group ( adjusted odds ratio from logistic regression , @ -LSB- @ % CI , @-@ @ -RSB- ) .


Mean ( SD ) length of stay for hospitalized patients was @ ( @ ) days for the NS group and @ ( @ ) days for the HS group ( P = @ ) .


The Respiratory Distress Assessment Instrument score decreased after treatment in both groups ; however , we found no significant difference between groups ( P = @ ) .


Hypertonic saline given to children with bronchiolitis in the ED decreases hospital admissions .


We can detect no significant difference in Respiratory Distress Assessment Instrument score or length of stay between the HS and NS groups .


This study aimed to examine diabetes self-care ( DSC ) patterns in low-income African American and Latino patients with Type @ diabetes , and identify patient-related , biomedical/disease-related , and psychosocial correlates of DSC .


We performed cross-sectional analysis of survey data from African Americans and Latinos aged @ years with Type @ diabetes ( n = @ ) participating in a diabetes self-management intervention at @ primary care clinics .


The Summary of Diabetes Self-Care Activities captured the subcomponents of healthy eating , physical activity , blood sugar testing , foot care , and smoking .


Correlates included patient-related attributes , biomedical/disease-related factors , and psychosocial constructs , with their multivariable influence assessed with a @-step model building procedure using regression techniques .


Baseline characteristics were as follows : mean age of @ years ( SD = @ ) ; @ % female ; @ % African American ; @ % with incomes below $ @,@ ; and @ % with less than a high school education .


DSC performance levels were highest for foot care ( @ / @ days ) and lowest for physical activity ( @ / @ days ) .


Across racial/ethnic subgroups , diabetes-related distress was the strongest correlate for DSC when measured as a composite score .


Psychosocial factors accounted for @ % to @ % of variance in self-care areas for both racial/ethnic groups .


Patient characteristics were more salient correlates in Hispanic/Latinos when examining the self-care subscales , particularly those requiring monetary resources .


Important information is provided on specific DSC patterns in a sample of ethnic/racial minorities with Type @ diabetes .


Significant correlates found may help with identification and intervention of patients who may benefit from strategies to increase self-care adherence .


Indications for home treatment for specific diagnoses in child and adolescent psychiatry have not yet been evaluated .


In a recent intervention study ( primary outcome : length of stay ) , @ patients aged @ to @ years were randomized into an intervention group ( early discharge followed by home treatment in combination with inpatient treatment , where needed ) and a control group ( regular length inpatient treatment ) .


The aim of this explorative analysis was to retrieve additional information on what works for whom .


Outcome parameters were as follows : Childrens Global Assessment Scale ( CGAS ) , Health of the Nation Outcome Scales for Children and Adolescents ( HoNOSCA ) , Strengths and Difficulties Questionnaire ( SDQ ) and Columbia Impairment Scale ( CIS ) at T@ ( within @ days after intake ) , T@ ( end of treatment ) and T@ ( @-month follow-up ) .


Multiple regression was used to investigate the association between diagnoses , treatment setting , age , sex , and improvement in both groups .


In children externalizing disorders were predominant , whereas in adolescents internalizing disorders were prominent .


Patients improved equally under both types of treatment .


Home treatment , however , was rated by the patients to be significantly more effective in adolescents ( SDQ p = @ ) , boys ( CIS p = @ , SDQ p < @ ) , and with externalizing disorders ( SDQ p = @ ) .


Home treatment may be considered an alternative to inpatient treatment , especially in boys with externalizing disorders .


To evaluate the efficacy of Fuzhenghuayu capsule for the prevention of oesophageal variceal bleeding in patients with liver cirrhosis .


A multicentre randomized placebo-controlled trial was conducted .


A total of @ liver cirrhosis patients were enrolled in the study and randomly assigned to different groups according to the level of oesophageal variceal bleeding .


Patients with light oesophageal varices received Fuzhenghuayu capsule or a placebo .


Patients with medium to heavy oesophageal varices received either Fuzhenghuayu capsule alone , Fuzhenghuayu capsule plus propranolol , or propranolol plus a placebo .


Patients with a history of oesophageal variceal bleeding received either Fuzhenghuayu capsule plus propranolol , propranolol alone , or a placebo .


For all patients , the treatment lasted @ years .


The primary end point of the study was oesophageal variceal bleeding .


The secondary end points were liver cancer , death by any cause , and liver transplantation .


Risk of bleeding and survival were statistically assessed .


The median follow-up time was @ months .


The patients with small oesophageal varices who were treated with Fuzhenghuayu capsule showed a significantly higher cumulative probability of bleeding than their counterparts treated with the placebo ( @ % vs. @ % , x = @ , P = @ ) .


The patients with medium to heavy oesophageal varices and no history of oesophageal variceal bleeding who were treated with Fuzhenghuayu capsule plus propranolol showed a remarkably higher cumulative probability of bleeding than their counterparts treated with propranolol alone ( @ % vs. @ % , x = @ , P = @ ) .


There were no significant differences between the patients treated with Fuzhenghuayu capsule alone and those treated with propranolol alone ( P = @ ) or the patients treated with Fuzhenghuayu capsule plus propranolol and those treated with Fuzhenghuayu capsule alone ( P = @ ) .


The patients with history of oesophageal variceal bleeding who were treated with Fuzhenghuayu capsule showed significantly higher cumulative probability of bleeding and median time of bleeding than their counterparts treated with propranolol alone ( @ % vs. @ % and @ @ months vs. @ @ months ; x = @ , P = @ ) .


There were no significant differences in the cumulative probability of liver cancer and survival among all of the groups .


Fuzhenghuayu capsule can decrease the cumulative probability of bleeding in cirrhotic patients with light oesophageal varices .


For cirrhosis patients with a history of oesophageal variceal bleeding , the combination of Fuzhenghuayu capsule plus propranolol can decrease the cumulative probability of bleeding with median or heavy varices .


The periodic health check-up has been a fundamental part of routine medical practice for decades , despite a lack of consensus regarding its value in health promotion and disease prevention .


A large-scale Danish population-based preventive programme ` Check your health ' was developed based on available evidence of screening and successive accepted treatment , prevention for diseases and health promotion , and is closely aligned with the current health care system.The objective of the ` Check your health ' -LSB- CORE -RSB- trial is to investigate effectiveness on health outcomes of a preventive health check offered at a population-level to all individuals aged @-@ years , and to establish the cost-effectiveness .


The trial will be conducted as a pragmatic household-cluster randomised controlled trial involving @,@ individuals .


All individuals within a well-defined geographical area in the Central Denmark Region , Denmark ( DK ) were randomised to be offered a preventive health check ( Intervention group , n = @ ) or to maintain routine access to healthcare until a delayed intervention ( Comparison group , n = @ ) .


The programme consists of a health examination which yields an individual risk profile , and according to this participants are assigned to one of the following interventions : ( a ) referral to a health promoting consultation in general practice , ( b ) behavioural programmes at the local Health Centre , or ( c ) no need for follow-up .


The primary outcomes at @ years follow-up are : ten-year-risk of fatal cardiovascular event ( Heart-SCORE model ) , physical activity level ( self-report and cardiorespiratory fitness ) , quality of life ( SF@ ) , sick leave and labour market attachment .


Cost-effectiveness will be evaluated according to life years gained , direct costs and total health costs .


Intention to treat analysis will be performed .


Results from the largest Danish health check programme conducted within the current healthcare system , spanning the sectors which share responsibility for the individual , will provide a scientific basis to be used in the development of systems to optimise population health in the @st century .


The randomized , double-blind Third International Study on Syncope of Uncertain Etiology ( ISSUE-@ ) showed that dual-chamber permanent pacing was effective in reducing the recurrence of syncope in patients @ years with severe asystolic , probably neurally mediated syncope ( NMS ) , documented by implantable loop recorder ( ILR ) .


Analysis in ISSUE-@ was performed according to the intention-to-treat principle .


In the present study , we performed an on-treatment analysis , which included additionally those non-randomized patients followed up in the ISSUE registry to evaluate in a better manner the effectiveness of cardiac pacing therapy .


Initially , @ patients received an ILR , @ ( @ % ) patients had a diagnosis consistent with NMS within a mean observation period of @ @ months : @ ( @ % ) patients had documentation of syncope with @ s asystole or @ s asystole without syncope .


Sixty patients affected by asystolic NMS received cardiac pacing therapy and @ ( @ asystolic and @ non-asystolic NMS ) were untreated ; @ patients were lost to follow-up .


Paced and unpaced groups had similar clinical characteristics .


During subsequent follow-up , syncope recurred in @ paced ( @ % ) and in @ non-paced ( @ % ) patients .


At @ months , the estimated product-limit syncope recurrence rates were @ % -LSB- @ % confidence interval ( CI ) @-@ -RSB- and @ % ( @ % CI @-@ ) , respectively ( P = @ ) .


With cardiac pacing , the risk of recurrence was reduced by @ % ( hazard ratio = @ , @ % CI = @-@ @ ) .


Complications of pacemaker therapy were haemothorax at implantation in one patient and lead dislodgement that required correction in two patients .


Permanent cardiac pacing is effective in reducing recurrence of syncope in patients @ years with severe asystolic possible NMS with a few complications .


The study shows that @ % of patients with a diagnosis of NMS made by ILR received a pacemaker but @ ILRs had to be implanted to find one patient who finally had a pacemaker implanted .


In the literature , data concerning the relationship between breast cancer and HLA class II gene polymorphisms are limited , so the aim of this study was to determine if HLA-DQB@ and HLA-DRB@ MHC class-II alleles may confer susceptibility or resistance to the disease among Jordanian females .


This case control study enrolled @ Royal Hospital breast cancer patients and @ age matched healthy controls , all of whom provided blood samples ( @-@ ) .


A questionnaire was filled after signing a consent form and DNA was extracted , nucleic acids being amplified for assessment of HLA-DQB@ and HLA-DRB@ alleles by muliplex INNO-LiPA and allele typing carried out by reverse hybridization .


Comparison of HLA-DQB@ and HLA-DRB@ allele distributions was carried out with paired t-test and chi-square statistics .


Risk factors were assessed by odd ratios with @ % confidence intervals .


A significant negative correlation was observed between HLADQB@ * @ alleles and breast cancers ( p = @ ) .


No significant associations were observed among HLADQB@ * @ , @ , @ and @ or among HLA-DRB@ * @ , @ , @ , @ , @ , @ , @ , @ , @ and @ .


HLADQB@ * @ alleles may provide positive protection against breast tumor risk among Jordanians , but not HLADQB@ * @ , @ , @ and @ or HLA-DRB@ * @ , @ , @ , @ , @ , @ , @ , @ , @ and @ alleles .


Intuitive eating is an eating approach that emphasizes increased focus on internal hunger and fullness cues to regulate eating behavior ; thus , successful intuitive eating should curb the influence of environmental factors such as plate and portion size on consumption .


The current study examined whether self-reported levels of intuitive eating moderated the influence of portion size on college students ' food consumption during an afternoon meal of pasta and tomato sauce .


Participants ( N = @ , @ % female ) were randomly assigned to either a large plate ( @-inch ) or small plate ( @-inch ) external cue condition .


All participants fasted for four daytime hours , completed the Intuitive Eating Scale , and then were asked to rate a meal of pasta and tomato sauce on different dimensions of taste .


Participants were told that they could eat as much pasta as they would like .


Higher levels of intuitive eating were associated with greater food consumption .


At the mean level of intuitive eating , participants ate more pasta in the large plate condition .


Furthermore , the influence of plate size on food consumption increased as levels of intuitive eating increased .


Individuals who report high levels of intuitive eating may be more likely to eat an objectively larger amount of food in a permissive food environment , and may have implications for eating approaches that promote eating in response to internal hunger and fullness cues .


Lactate measurement has been used to identify critical medical illness and initiate early treatment strategies .


The prehospital environment offers an opportunity for very early identification of critical illness and commencement of care .


The investigators hypothesized that point-of-care lactate measurement in the prehospital aeromedical environment would : ( @ ) identify medical patients with high mortality ; ( @ ) influence fluid , transfusion , and intubation ; and ( @ ) increase early central venous catheter ( CVC ) placement .


Critically ill , medical , nontrauma patients who were transported from September @ through February @ by University of Massachusetts ( UMass ) Memorial LifeFlight , a university-based emergency medical helicopter service , were eligible for enrollment .


Patients were prospectively randomized to receive a fingerstick whole-blood lactate measurement on an alternate-day schedule .


Flight crews were not blinded to results .


Flight crews were asked to inform the receiving attending physician of the results .


The primary endpoint was the ability of a high , prehospital lactate value -LSB- > @ millimoles per liter ( mmol/L ) -RSB- to identify mortality .


Secondary endpoints included differences in post-transport fluid , transfusion , and intubation , and decrease in time to central venous catheter ( CVC ) placement .


Categorical variables were compared between groups by Fisher 's Exact Test , and continuous variables were compared by t-test .


Patients ( N = @ ) were well matched for age , gender , and acuity .


In the lactate cohort ( n = @ ) , mean lactate was @ mmol/L -LSB- Standard error of the mean , SEM = @ -RSB- .


Initial analysis revealed that prehospital lactate levels of @ mmol/L did show a trend toward higher mortality with an odds ratio of @ ( @ % CI , @-@ @ ) .


Secondary endpoints did not show a statistically significant change in management between the lactate and non lactate groups .


There was a trend toward decreased time to post-transport CVC in the non lactate faction .


Prehospital aeromedical point-of-care lactate measurement levels @ mmol/L may help stratify mortality .


Further investigation is needed , as this is a small , limited study .


The initial analysis did not find a significant change in post-transport management .


Online interventions have emerged as a popular strategy to promote healthy behaviors .


Currently , there is little agreement about how to capture online intervention engagement .


It is also uncertain who engages with weight-related online interventions and how engagement differs by demographic and weight characteristics .


The objectives of this study were to ( @ ) characterize how pregnant women engaged with features of an online intervention to prevent excessive gestational weight gain , ( @ ) identify demographic and weight status subgroups of women within the sample , and ( @ ) examine differences in use of intervention features across the demographic and weight status subgroups .


A sample of racially and socioeconomically diverse pregnant women from a northeastern US city was assigned to the intervention group in a randomized controlled trial to prevent excessive gestational weight gain ( n = @ ) .


The intervention website included these features : weight-gain tracker , health-related articles , blogs , physical activity and diet goal-setting tools , and local resources .


Engagement variables were created to capture the amount , consistency , and patterns of feature use across pregnancy using latent class analysis .


Demographic/weight status subgroups were also created using latent class analysis .


Differences in engagement across the demographic/weight status subgroups were examined using chi-square analysis .


Six engagement patterns emerged : `` super-users '' ( @ % , @/@ ) , `` medium-users '' ( @ % , @/@ ) , `` consistent weight-tracker users '' ( @ % , @/@ ) ; `` almost consistent weight-tracker users '' ( @ % , @/@ ) , `` inconsistent weight-tracker users '' ( @ % , @/@ ) , and `` non-users '' ( @ % , @/@ ) .


Four demographic/weight status subgroups emerged : three minority and one white .


There were different engagement patterns by demographic/weight status subgroups .


Super-users were more likely to be in the white subgroup , while non-users were more likely to be in the minority subgroups .


However , around a third of women in minority subgroups were consistently or almost consistently engaging with the weight-tracker ( black , young women , @ % , @/@ ; black , heavier women , @ % , @/@ ; Hispanic women , @ % , @/@ ) .


While white and higher income women had higher engagement in general , depending on the measure , there was still considerable engagement by the minority and low-income women .


To test whether supervised pelvic floor exercises antenatally will reduce the incidence of postpartum stress incontinence in at-risk primigravidae with bladder neck mobility , ultrasonically proven .


Single blind , randomised controlled trial .


Antenatal clinic in a UK NHS Trust Hospital .


Two hundred and sixty-eight primigravidae attending an antenatal clinic at approximately @ weeks of gestation with bladder neck mobility , on standardised valsalva , of @ mm or more linear movement .


The median age was @ , ranging from @ to @ years .


Patients randomised to supervised pelvic floor exercises ( n = @ ) attended a physiotherapist at monthly intervals from @ weeks until delivery .


The exercises comprised three repetitions of eight contractions each held for six seconds , with two minutes rest between repetitions .


These were repeated twice daily .


At @ weeks of gestation the number of contractions per repetition was increased to @ .


Both the untreated control group and the study group received verbal advice on pelvic floor exercises from their midwives antenatally .


Subjective reporting of stress incontinence at three months postpartum .


Pelvic floor strength , using perineometry , and bladder neck mobility measured by perineal ultrasound .


Of the @ women enrolled , information on the main outcome variable was available for @ in the control group and @ in the study group .


Fewer women in the supervised pelvic floor exercise group reported postpartum stress incontinence , @ % compared with @ % in the control group ( RR @ -LSB- @-@ @ -RSB- ) .


There was no change in bladder neck mobility and no difference in pelvic floor strength between groups after exercise , although all those developing postpartum stress incontinence had significantly poorer perineometry scores than those who were continent .


The findings suggest that antenatal supervised pelvic floor exercises are effective in reducing the risk of postpartum stress incontinence in primigravidae with bladder neck mobility .


The aim of the present study was to evaluate the procedural feasibility , the safety and the @-year outcome following left atrial appendage ( LAA ) closure using the Amplatzer cardiac plug ( ACP ) in Belgium .


Data were prospectively collected among @ consecutive patients , undergoing LAA closure with an ACP in @ Belgian centres between June @ and September @ .


The patients ( @ males , @ + / - @ years ) were at high risk for stroke ( CHA@DS@-VASc = @ + / - @ ) and bleeding ( HAS-BLED = @ + / - @ ) .


Technical success was obtained in all but one patient and procedural success was @ % .


Procedural major adverse events ( MAE ) were @ tamponades resulting in death in one case .


Minor complications were @ insignificant pericardial effusions , @ transient myocardial ischaemia due to air embolism and @ femoral pseudoaneurysm .


At @-y follow-up , there were @ deaths , @ minor strokes , @ tamponade and @ myocardial infarction .


Overall survival was @ % and freedom from MAE was @ % .


In our population , the expected annual stroke risk according to the CHA@DS@-VASc score was @ % , while the observed stroke rate was @ % / year .


The Belgian registry shows that LAA closure using the ACP device is feasible and safe .


At @-y follow-up , the observed stroke rate was @ % / year , less than predicted by the CHA@DS@-VASc score .


Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke .


Self-monitoring by mobile phone applications offers new opportunities to engage patients in self-management .


Self-monitoring has not been examined thoroughly as a self-directed intervention strategy for self-management of multiple behaviors and states by people living with HIV ( PLH ) .


PLH ( n = @ ) , primarily African American and Latino , were recruited from @ AIDS services organizations and randomly assigned to daily smartphone ( n = @ ) or biweekly Web-survey only ( n = @ ) self-monitoring for @ weeks .


Smartphone self-monitoring included responding to brief surveys on medication adherence , mental health , substance use , and sexual risk behaviors , and brief text diaries on stressful events .


Qualitative analyses examine biweekly open-ended user-experience interviews regarding perceived benefits and barriers of self-monitoring , and to elaborate a theoretical model for potential efficacy of self-monitoring to support self-management for multiple domains .


Self-monitoring functions include reflection for self-awareness , cues to action ( reminders ) , reinforcements from self-tracking , and their potential effects on risk perceptions , motivations , skills , and behavioral activation states .


Participants also reported therapeutic benefits related to self-expression for catharsis , nonjudgmental disclosure , and in-the-moment support .


About one-third of participants reported that surveys were too long , frequent , or tedious .


Some smartphone group participants suggested that daily self-monitoring was more beneficial than biweekly due to frequency and in-the-moment availability .


About twice as many daily self-monitoring group participants reported increased awareness and behavior change support from self-monitoring compared with biweekly Web-survey only participants .


Self-monitoring is a potentially efficacious disruptive innovation for supporting self-management by PLH and for complementing other interventions , but more research is needed to confirm efficacy , adoption , and sustainability .


The purpose of this study was to compare the clinical efficacy of an anorganic bovine bone graft particulate to that of a calcium phosphosilicate putty alloplast for socket preservation .


Thirty teeth were extracted from @ patients .


The sockets were debrided and received anorganic bovine bone mineral ( BOV , n = @ ) , calcium phosphosilicate putty ( PUT , n = @ ) , or no graft ( CTRL , n = @ ) .


The sockets were assessed clinically and radiographically @ months later .


Eight sockets in the BOV group and nine in the PUT group received implants @ to @ months postgrafting .


The maximum implant insertion torque ( MIT ) was measured as an index of primary implant stability .


The data were analyzed with the Mann-Whitney test .


Both test groups had statistically significantly less reduction in mean ridge width ( BOV : @ mm ; PUT : @ mm ) in comparison to the control group ( @ mm ) .


No statistically significant difference was identified between the test groups .


MIT for PUT was @ N/cm ( MIT grade @ ) for seven of the nine implants .


MIT values in the BOV group ranged from grade @ ( @ to @ N/cm ) to grade @ , which was statistically significantly lower than for the PUT group .


The overall implant success rate was @ % ( @ of @ implants were successful ) .


No implants were lost in the PUT group ; one implant failed in the BOV group .


Both tested bone substitutes can be recommended for preservation of alveolar ridge width following extraction .


PUT might be more suitable for achieving primary stability for implants placed at @ to @ months postextraction .


There is convincing evidence that unsaturated fatty acids exert favourable effects on plasma cholesterol levels .


However , it is not clear which type of oil has the most pronounced effect , especially not in paediatric patients .


The aim was to compare two low-fat diet regimes enriched with either monounsaturated fatty acids by rapeseed oil ( RO ) or polyunsaturated fatty acids by sunflower oil ( SO ) in children affected with familial hypercholesterolaemia ( FH ) .


Twenty-one children aged @-@ years affected with FH were enrolled in this randomized and double-blind pilot trial .


The subjects and their families were trained to adhere to a low-fat/low-cholesterol diet .


All visible fats were to be replaced by either RO or SO ( @-@g / day ) for @ weeks .


Dietary adherence was controlled by repeated @-day dietary records ; plasma lipids , lipoproteins and risk markers were assessed at baseline and post-intervention .


Out of @ subjects , @ could be followed-up after @ months .


Both fat-modified diets resulted in significant reduction in total cholesterol concentrations of @ % ( RO P < @ vs SO P < @ ) and low-density lipoprotein ( LDL ) cholesterol concentrations of @ % ( P < @ ) for RO and @ % ( P < @ ) for SO .


The reduction of the LDL/high-density lipoprotein ( HDL ) cholesterol ratio ( RO @ % vs SO @ % ) and high-sensitivity C-reactive protein ( RO @ % vs SO @ % ) were not statistically significant , respectively .


In most participating families , a change in eating habits could be observed .


A fat-modified diet enriched with RO seems to have very similar effects on cholesterol levels as with SO .


However , our study suggests that RO has possibly more favourable effects concerning cardiovascular risk profile .


Both diets appear to be feasible and were well accepted among our subjects .


Although these results are promising , larger trials will be required to validate our findings .


The present analysis describes the longitudinal change in buprenorphine treatment outcome .


It also examines several participant characteristics to predict response to buprenorphine .


Participants ( n = @ , age > @ years ) received buprenorphine/naloxone treatment for @ weeks , and then were randomly assigned to undergo dose tapering over either @ days or @ days .


An empirical model was developed to describe the longitudinal changes in treatment outcome .


Several patient characteristics were also examined as possible factors influencing treatment outcome .


We have developed a model that captures the general behavior of the longitudinal change in the probability of having an opioid-negative urine sample following buprenorphine treatment .


The model captures both the initial increase ( i.e. , initial response ) and the subsequent decrease ( i.e. , relapse to opioid ) in the likelihood of providing an opioid-negative urine sample .


Characteristics associated with successful buprenorphine treatment outcome include : having a negative urine test for drugs , having alcohol problems -LSB- assessed using alcohol domain of addiction severity index ( ASI-alcohol ) -RSB- at screening , being older , and receiving low cumulative buprenorphine dose .


However , ASI-alcohol values were generally low which make the application of the proposed alcohol effect for patients with more severe alcohol problems questionable .


A novel approach for analyzing buprenorphine treatment outcome is presented in this manuscript .


This approach describes the longitudinal change in the probability of providing an opioid-free urine sample instead of considering opioid use outcome at a single time point .


Additionally , this model successfully describes relapse to opioid .


Finally , several patient characteristics are identified as predictors of treatment outcome .


We compared the quantitative clinical performances of the streamlined liner of the pharynx airway ( SLIPA ) and the ProSeal laryngeal mask airway ( LMA ProSeal ) regarding intensity of gastric distension in patients undergoing laparoscopic cholecystectomy .


A total of @ anesthetized , paralyzed patients ( ASA @ to @ ; aged , @ to @ y ) were randomly allocated for airway management with the SLIPA or LMA ProSeal .


After induction of general anesthesia using total intravenous anesthesia and rocuronium , the intensity of gastric distension was accessed twice by @ raters , respectively .


We also compared the fiberoptic bronchoscopic view of the glottis , the severity of blood stain , and postoperative sore throat .


There were no statistically significant differences between groups for each gastric size .


The change of gastric size within the SLIPA group was not statistically significant for both raters .


Change within the LMA ProSeal group was significant in rater @ ( P = @ ) and marginally significant for rater @ ( P = @ ) .


Anatomic fit , complications during emergence , and the severity of blood stain and postoperative sore throat were similar in both groups .


SLIPA is as efficacious as LMA ProSeal for use in patients without severe complications who are undergoing laparoscopic cholecystectomy .


To investigate the effectiveness of brief intervention ( BI ) conducted in the workplace for heavy drinkers .


A randomized controlled trial was conducted at six companies in Japan .


Participants were heavy drinkers who met the inclusion criteria and were randomized into three groups : the BI group , BI with diary group and a control group .


Outcomes ( total drinks , binge drinking episodes and alcohol-free days ) were evaluated at @ and @ months .


The @ participants recruited were allocated to the three groups and @ participated in all follow-up evaluations .


Dropout rates in the respective groups were @ , @ and @ % .


Some improvements were observed in all the groups .


In particular , alcohol-free days in the BI group were significantly increased by @ % at @ months .


Total drinks at @ months were reduced by @ g per week in the BI group compared with the control group , although the intergroup difference was not significant .


BI in the workplace is effective for increasing the number of alcohol-free days .


However , the effectiveness on decreasing alcohol consumption was unclear , which could be explained by alcohol screening itself causing a reduction in drinking .


Several observational studies were conducted with vildagliptin in patients with type @ diabetes mellitus ( T@DM ) fasting during Ramadan , showing significantly lower incidences of hypoglycemia with vildagliptin versus sulfonylureas , including gliclazide .


It was of interest to complement the existing real-life evidence with data from a randomized , double-blind , clinical trial .


NCT@ .


This multiregional , double-blind study randomized @ patients with T@DM ( mean glycated hemoglobin -LSB- HbA@c -RSB- , @ % ) , previously treated with metformin and any sulfonylurea to receive either vildagliptin ( @ mg twice daily ) or gliclazide plus metformin .


The study included four office visits ( three pre-Ramadan ) and multiple telephone contacts , as well as Ramadan-focused advice .


Hypoglycemic events were assessed during Ramadan ; HbA ( @c ) and weight were analyzed before and after Ramadan .


The proportion of patients reporting confirmed ( < @ mmol/L and/or severe ) hypoglycemic events during Ramadan was @ % with vildagliptin and @ % with gliclazide ( P = @ ; one-sided test ) , and this was @ % and @ % , respectively , for any hypoglycemic events ( P = @ ) .


The adjusted mean change pre - to post-Ramadan in HbA ( @c ) was @ % @ % with vildagliptin and -@ % @ % with gliclazide , from baselines of @ % and @ % , respectively ( P = @ ) .


In both groups , the adjusted mean decrease in weight was -@ kg ( P = @ ) .


Overall safety was similar between the treatments .


In line with the results from previous observational studies , vildagliptin was shown in this interventional study to be an effective , safe , and well-tolerated treatment in patients with T@DM fasting during Ramadan , with a consistently low incidence of hypoglycemia across studies , accompanied by good glycemic and weight control .


In contrast , gliclazide showed a lower incidence of hypoglycemia in the present interventional than the previous observational studies .


This is suggested to be linked to the specific circumstances of this study , including frequent patient-physician contacts , Ramadan-focused advice , a recent switch in treatment , and very well-controlled patients , which is different from what is often seen in real life .


AMG @ pharmacokinetics/pharmacodynamics ( PK/PD ) , safety , tolerability and effects after single subcutaneous ( s.c. ) or intravenous ( i.v. ) administration were evaluated in a randomized , double-blind , placebo-controlled study .


Healthy male subjects ( n = @ ) received a single dose of AMG @ or placebo at @ , @ , @ , @ , @mg s.c. ( or i.v. ) , @mg s.c. ( or i.v. ) , @mg i.v. or placebo .


Four ulcerative colitis ( UC ) subjects ( n = @ , male : female @:@ ) received @mg AMG @ or placebo s.c. ( @:@ ) .


AMG @ concentration , anti-AMG @-antibody ( ADA ) , @ @ receptor occupancy ( RO ) , target cell counts , serum C-reactive protein , fecal biomarkers and Mayo score were measured .


Subjects were followed @-@ months after dose .


Following s.c. dosing , AMG @ was absorbed with a median tmax ranging between @-@ days and a bioavailability between @ % and @ % .


Cmax and AUC increased dose-proportionally and approximately dose-proportionally , respectively , within the @-@mg s.c. and @-@mg i.v. ranges .


The linear - phase t@/@ was @ ( range @-@ ) days .


Target-mediated disposition occurred at serum AMG @ concentrations of less than @gml ( -@ ) .


The PD effect on @ @ RO showed an EC@ of @ gml ( -@ ) .


Lymphocytes , eosinophils , CD@ + T cells and subset counts were unchanged .


AMG @-treated UC subjects were in remission with mucosal healing at weeks @ , @ and/or @ .


The placebo-treated UC subject experienced colitis flare at week @ .


No ADA or AMG @ treatment-related serious adverse events were observed .


AMG @ has PK/PD , safety , and effect profiles suitable for further testing in subjects with inflammatory bowel diseases .


Behavioral migraine approaches are effective in reducing headache attacks .


Availability of treatment might be increased by using migraine patients as trainers .


Therefore , Mrelle and colleagues developed and evaluated a home-based behavioral management training ( BMT ) by lay trainers ( @ ) .


The maintenance of effects at long-term follow-up is studied in the present study .


Measurements were taken pre-BMT ( T@ ) , post-BMT ( T@ ) , at six-month follow-up ( T@ ) , and at long-term follow-up , i.e. two to four years after BMT ( T@ ) .


Data of @ participants were analyzed with longitudinal multi-level analyses .


Short-term improvements in attack frequency and self-efficacy post-BMT were maintained at long-term follow-up ( DT@T@ = -@ and DT@T@ = @ , respectively ) .


The level of internal control that increased during BMT decreased from post-BMT to long-term follow-up ( DT@T@ = @ ) .


Quality of life and migraine-related disability improved gradually over time ( DT@T@ = @ and DT@T@ = -@ , respectively ) .


Although the results should be interpreted with caution because of the lack of a follow-up control group and the inability to gather information about additional treatments patients may have received during the follow-up period , the findings suggest that lay BMT for migraine may be beneficial over the long term .


If so , this could make migraine treatments more widely available .


: Although numerous animal studies suggest that probiotic therapy has beneficial effects in various liver diseases , the evidence for beneficial effects in human liver disease is controversial .


This study was carried out to investigate the efficacy of probiotic therapy in alleviating small intestinal bacterial overgrowth ( SIBO ) and permeability in chronic liver disease .


Fifty-three patients with chronic liver disease were randomized to either probiotic therapy or placebo .


Six bacterial species were used : Bifidobacterium bifidum , Bifidobacterium lactis , Bifidobacterium longum , Lactobacillus acidophilus , Lactobacillus rhamnosus , and Streptococcus thermophilus .


After @ weeks , changes in the composition of fecal bacteria , SIBO , intestinal permeability , and clinical symptoms were examined .


Three of the six probiotic species , B. lactis , L. rhamnosus , and L. acidophilus , increased in the feces of the probiotic therapy group ( P < @ ) , whereas there was no change in fecal microbiota in the placebo group .


SIBO disappeared in many individuals of the probiotic therapy group , but none in the placebo ( @ vs. @ % , P < @ ) .


General gastrointestinal symptoms also improved more in the probiotic group and improvement in intestinal permeability was slightly but not significantly more frequent in the probiotic arm than the placebo arm ( @ vs. @ % , P = @ ) .


Numbers of lactobacilli in stool were correlated negatively with intestinal permeability ( P for trend < @ ) .


Liver chemistry did not improve significantly in either group .


We conclude that short-term probiotic administration in chronic liver disease is effective in alleviating SIBO and clinical symptoms , but ineffective in improving intestinal permeability and liver function .


Hydration to prevent contrast-induced acute kidney injury ( CI-AKI ) induces a diagnostic delay when performing computed tomography-pulmonary angiography ( CTPA ) in patients suspected of having acute pulmonary embolism .


To analyze whether withholding hydration is non-inferior to sodium bicarbonate hydration before CTPA in patients with chronic kidney disease ( CKD ) .


We performed an open-label multicenter randomized trial between @ and @ .


One hundred thirty-nine CKD patients were randomized , of whom @ were included in the intention-to-treat population : @ were randomized to withholding hydration and @ were randomized to @-h @mL @ % sodium bicarbonate hydration before CTPA .


Primary outcome was the increase in serum creatinine @-@h after CTPA .


Secondary outcomes were the incidence of CI-AKI ( creatinine increase > @ % / > @ mgdL ( -@ ) ) , recovery of renal function , and the need for dialysis within @months after CTPA .


Withholding hydration was considered non-inferior if the mean relative creatinine increase was @ % compared with sodium bicarbonate .


Mean relative creatinine increase was -@ % ( interquartile range -@ % to @ % ) for withholding hydration and -@ % ( interquartile range -@ % to @ % ) for sodium bicarbonate ( mean difference @ % , @ % confidence interval -@ % to @ % , P-value non-inferiority < @ ) .


CI-AKI occurred in @ patients ( @ % ) : @ ( @ % ) were randomized to withholding hydration and @ ( @ % ) to sodium bicarbonate ( relative risk @ , @ % confidence interval @-@ @ ) .


Renal function recovered in @ % of CI-AKI patients within each group ( relative risk @ , @ % confidence interval @-@ @ ) .


None of the CI-AKI patients developed a need for dialysis .


Our results suggest that preventive hydration could be safely withheld in CKD patients undergoing CTPA for suspected acute pulmonary embolism .


This will facilitate management of these patients and prevents delay in diagnosis as well as unnecessary start of anticoagulant treatment while receiving volume expansion .


To evaluate the impact of sending an email to responsible parties of completed trials that do not comply with the Food and Drug Administration Amendments Act @ legislation , to remind them of the legal requirement to post results .


Cohort embedded pragmatic randomized controlled trial .


Trials registered on ClinicalTrials.gov .


@ out of @ trials randomly selected by computer generated randomization list to receive the intervention ( personalized emails structured as a survey and sent by one of us to responsible parties of the trials , indirectly reminding them of the legal requirement and potential penalties for non-compliance ) .


The primary outcome was the proportion of results posted on ClinicalTrials.gov at three months .


The secondary outcome was the proportion posted at six months .


In a second step , two assessors blinded to the intervention group collected the date of the first results being received on ClinicalTrials.gov .


A post hoc sensitivity analysis excluding trials wrongly included was performed .


Among @ trials included , @ were randomized to receive the email intervention .


The rate of posting of results did not differ at three months between trials with or without the intervention : @/@ ( @ % ) v @/@ ( @ % ) , respectively ( relative risk @ , @ % confidence interval @ to @ , P = @ ) but did at six months : @/@ ( @ % ) v @/@ ( @ % ) , @ , @ to @ , P = @ .


In the sensitivity analysis , which excluded @/@ trials ( @ % ) , @/@ ( @ % ) and @/@ ( @ % ) , respectively , results were significant at three months ( relative risk @ , @ to @ , P = @ ) and at six months ( @ , @ to @ , P = @ ) .


Sending email reminders about the FDA 's legal requirement to post results at ClinicalTrials.gov improved significantly the posting rate at six months but not at three months.Trial registration ClinicalTrials.gov NCT@ .


Restless leg syndrome ( RLS ) is one of the prevalent complaints of patients with end stage renal diseases suffering chronic hemodialysis .


Although there are some known pharmacological managements for this syndrome , the adverse effect of drugs causes a limitation for using them .


In this randomized clinical trial we aimed to find a nonpharmacological way to improve signs of restless leg syndrome and patients ' quality of life .


Twenty-six patients were included in the study and divided into @ groups of control and exercise .


The exercise group used aerobic exercise during their hemodialysis for @ weeks .


The quality of life and severity of restless leg syndrome were assessed at the first week of study and final week .


Data were analyzed using SPSS software .


The difference of means of RLS signs at the first week of study and final week was -@ @ in exercise group and -@ @ in control group .


There was not any statistical difference between control group and exercise group in quality of life at the first week of study and final week .


We suggest using aerobic exercise for improving signs of restless leg syndrome , but no evidence was found for its efficacy on patient 's quality of life .


Randomized controlled trials in developed countries have reported benefits of Lactobacillus GG ( LGG ) in the treatment of acute watery diarrhoea , but there is paucity of such data from India .


The study was aimed to evaluate the efficacy and safety of Lactobacillus GG in the treatment of acute diarrhoea in children from a semi-urban city in north India .


In this open labelled , randomized controlled trial @ children with acute watery diarrhoea , aged between @ months to @ years visiting outpatient department and emergency room of a teaching hospital in north India were enrolled .


The children were randomized into receiving either Lactobacillus GG in dose of @ billion cfu/day for five days or no probiotic medication in addition to standard WHO management of diarrhoea .


Primary outcomes were duration of diarrhoea and time to change in consistency of stools .


Median ( inter quartile range ) duration of diarrhoea was significantly shorter in children in LGG group -LSB- @ ( @-@ ) h vs. @ ( @-@ ) h ; P < @ -RSB- .


Also , there was faster improvement in stool consistency in children receiving Lactobacillus GG than control group -LSB- @ ( @-@ ) h vs. @ ( @-@ ) h ; P < @ -RSB- .


There was significant reduction in average number of stools per day in LGG group ( P < @ ) compared to the control group .


These benefits were seen irrespective of rotavirus positivity in stool tests .


Our results showed that the use of Lactobacillus GG in children with acute diarrhoea resulted in shorter duration and faster improvement in stool consistency as compared to the control group .


In persons @ years and above in South Africa the prevalence of pre-diabetes and diabetes has been estimated at @ % and @ % , respectively , and the prevalence of systolic prehypertension and hypertension , @ % and @ % , respectively .


Elevated blood glucose and elevated blood pressure are prototype of preventable chronic cardiovascular disease risk factors.Lifestyle interventions have been shown to control high normal blood pressure and/or high normal blood glucose .


This study proposes to evaluate the efficacy of a community ( church ) - based lifestyle intervention programme to control high normal blood pressure and/or high normal blood glucose in church members in a randomized controlled trial in Gauteng , South Africa .


The objectives are to : ( @ ) measure non-communicable diseases profile , including hypertension and diabetes , health behaviours , weight management and psychological distress of church members ; ( @ ) measure the reduction of blood glucose and blood pressure levels after the intervention ; ( @ ) prevent the development of impaired glucose tolerance ; ( @ ) compare health behaviours , weight management and psychological distress , blood glucose and blood pressure levels between intervention and control groups , and within group during @ , @ , @ and @ months during and post intervention .


The study will use a group-randomized design , recruiting @ church members from @ churches .


Churches will be randomly assigned to experimental and control conditions .


Lifestyle interventions may prevent from the development of high blood pressure and/or diabetes .


The findings will impact public health and will enable the health ministry to formulate policy related to lifestyle interventions to control blood pressure and glucose .


The aim of the present study was to analyze the efficacy of Papacarie ( ) gel compared with the traditional method ( low-speed bur ) in reducing the counts of total bacteria , Lactobacillus , total Streptococcus and Streptococcus mutans group .


A randomized , controlled clinical trial with a split-mouth design was performed .


The sample comprised @ deciduous teeth in @ children ( @ males and @ females ) aged four to seven years .


The teeth were randomly allocated to two groups : G@ , or chemomechanical caries removal with Papacarie Duo ( ) , and G@ , or the removal of carious dentin tissue with a low-speed bur .


Infected dentin was collected prior to the procedure , and the remaining dentin was collected immediately following the removal of the carious tissue .


Initial and final counts of bacterial colonies were performed to determine whether there was a reduction in the number of colony-forming units ( CFUs ) of each microorganism studied .


ClinicalTrials.gov : NCT@ .


Reductions were found in the numbers of total bacteria , total Streptococcus and Streptococcus mutans group following either of the caries removal methods ( p < @ ) .


A reduction was also noted in the number of Lactobacillus CFUs ; however , this difference did not achieve statistical significance ( p > @ ) .


Papacarie ( ) is an excellent option for the minimally invasive removal of carious tissue , achieving significant reductions in total bacteria , total Streptococcus and S. mutans with the same effectiveness as the traditional caries removal method .


Studies in animals and in vitro and phase @ studies in humans suggest that statins may be beneficial in the treatment of the acute respiratory distress syndrome ( ARDS ) .


This study tested the hypothesis that treatment with simvastatin would improve clinical outcomes in patients with ARDS .


In this multicenter , double-blind clinical trial , we randomly assigned ( in a @:@ ratio ) patients with an onset of ARDS within the previous @ hours to receive enteral simvastatin at a dose of @ mg or placebo once daily for a maximum of @ days .


The primary outcome was the number of ventilator-free days to day @ .


Secondary outcomes included the number of days free of nonpulmonary organ failure to day @ , mortality at @ days , and safety .


The study recruited @ patients , with @ patients assigned to simvastatin and @ to placebo .


The groups were well matched with respect to demographic and baseline physiological variables .


There was no significant difference between the study groups in the mean ( SD ) number of ventilator-free days ( @ with simvastatin and @ with placebo , P = @ ) or days free of nonpulmonary organ failure ( @ and @ , respectively ; P = @ ) or in mortality at @ days ( @ % and @ % , respectively ; P = @ ) .


There was no significant difference between the two groups in the incidence of serious adverse events related to the study drug .


Simvastatin therapy , although safe and associated with minimal adverse effects , did not improve clinical outcomes in patients with ARDS .


( Funded by the U.K. National Institute for Health Research Efficacy and Mechanism Evaluation Programme and others ; HARP-@ Current Controlled Trials number , ISRCTN@ . )


Despite improvements in endovascular therapy for lower extremity arterial disease , open surgical revascularization is still required when the disease is extensive .


Although autogenous vein is the conduit of choice for open femoropopliteal bypass , prosthetic grafts can be an acceptable alternative when adequate vein is not available .


The FUSION BIOLINE heparin-coated vascular graft ( Maquet Endovascular , Wayne , NJ ) was developed to improve the patency rate associated with standard prosthetic grafts .


The current study , the FINEST Trial ( Comparison of Safety and Primary Patency Between the FUSION BIOLINE Heparin-Coated Vascular Graft and EXXCEL Soft ePTFE ) , was designed to assess the clinical outcome of heparin-coated and standard vascular grafts in a prospective , randomized , controlled , multicenter trial .


During a @-month period ending in June @ , @ eligible patients scheduled to undergo elective prosthetic femoral to above-knee or below-knee popliteal bypass were randomized to receive a standard expanded polytetrafluoroethylene ( ePTFE ) graft or the heparin-coated FUSION BIOLINE vascular graft .


Among @ patients in the efficacy analysis , claudication was the presenting symptom in @ ( @ % ) , and the site of the distal anastomosis was at the above-knee level in @ ( @ % ) .


Grafts were assessed by duplex ultrasound imaging and ankle-brachial indices performed postoperatively at discharge and at @ days , @ months , and @ months .


The primary efficacy end point was primary patency of the study graft .


The primary safety end point was the composite of major adverse events and periprocedural death .


Secondary end points included the time to hemostasis of bleeding at the anastomotic suture hole and primary assisted and secondary patency .


The primary patency rates at @ months were @ % for the FUSION BIOLINE heparin-coated vascular graft group compared with @ % for the standard ePTFE group , a difference of @ % ( @ % confidence interval , @ % -@ % ; P = @ ) , and the respective rates at @ months were @ % and @ % ( @ % confidence interval , -@ % to @ % ; P = @ ) .


The mean time to hemostasis of bleeding at the suture hole was @ minutes in the FUSION BIOLINE group and @ minutes in the standard ePTFE group ( P < @ ) .


Major adverse events were significantly lower in the FUSION BIOLINE group , occurring in @ % , compared with @ % in the standard ePTFE group ( P = @ ) , principally a result of a lower rate of major graft reinterventions through @ months in the FUSION BIOLINE group ( @ % vs @ % ) .


Data from this randomized multicenter study demonstrated improved midterm patency , less bleeding at the suture hole , and lower major adverse events with the FUSION BIOLINE heparin-coated vascular graft compared with standard ePTFE grafts .


Although the ultimate long-term benefit of the graft can not be ascertained with the data currently available , the utility of the FUSION BIOLINE vascular graft appears promising .


To describe the spectrum of cognitive outcomes of children with and without cerebral palsy ( CP ) after neonatal encephalopathy , evaluate the prognostic value of early developmental testing and report on school services and additional therapies .


The participants of this study are the school-aged survivors of the National Institute of Child Health and Human Development Neonatal Research Network randomized controlled trial of whole-body hypothermia .


Children underwent neurologic examinations and neurodevelopmental and cognitive testing with the Bayley Scales of Infant Development-II at @ to @ months and the Wechsler intelligence scales and the Neuropsychological Assessment-Developmental Neuropsychological Assessment at @ to @ years .


Parents were interviewed about functional status and receipt of school and support services .


We explored predictors of cognitive outcome by using multiple regression models .


Subnormal IQ scores were identified in more than a quarter of the children : @ % of survivors with CP had an IQ < @ , @ % of children without CP had an IQ < @ , and @ % had an IQ of @ to @ .


Children with a mental developmental index < @ at @ months had , on average , an adjusted IQ at @ to @ years that was @ points lower than that of those with a mental developmental index > @ ( @ % confidence interval , -@ to -@ ; P < @ ) .


Twenty percent of children with normal IQ and @ % of those with IQ scores of @ to @ received special educational support services or were held back @ grade level .


Cognitive impairment remains an important concern for all children with neonatal encephalopathy .


A fiberglass short arm cast can be used to treat a distal radial fracture , but posttraumatic edema may lead to excessive cast tightness and resultant soft-tissue injury .