The intent-to-treat analysis included @,@ patients ( @,@ catheters , @,@ catheter-days , and @,@ study locks ) .


Median DC duration was @ days ( interquartile range , @-@ ) and was similar in both groups .


Major CRI incidence did not differ between the ethanol and control groups ( @ vs. @ per @,@ catheter-days , respectively ; hazard ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


No significant differences occurred for catheter colonization ( P = @ ) or catheter-related bloodstream infection ( P = @ ) .


A @-minute ethanol lock does not decrease the frequency of infection of DCs in ICU patients .


Clinical trial registered with www.clinicaltrials.gov ( NCT @ ) .


Comparison of efficacy and safety of two different regimens of vitamin D-@ @ IU as a single intramuscular dose , and @ @IU orally once a week for @ weeks-in treatment of nutritional rickets .


Children with nutritional rickets ( age : @-@ years , n = @ ) were randomized to receive either @ @IU vitamin D orally once a week for @ weeks or @ @IU single intramuscular injection .


Serum calcium , phosphate , alkaline phosphatase , urinary calcium/creatinine ratio , serum @ hydroxy vitamin D and radiological score were compared at @-week follow-up .


No difference was found in efficacy of the two regimens on comparing biochemical and radiological parameters .


Serum @ hydroxy vitamin D > @ ng/ml was found in two children in the oral group and one child in the intramuscular group .


No child developed hypercalcemia or hypercalciuria after starting treatment .


Staggered oral and one-time intramuscular administrations of @ @IU vitamin D are equally effective and safe in treatment of nutritional rickets .


Psychiatric disorders are common among patients with irritable bowel syndrome ( IBS ) which may make a psychiatric evaluation appropriate .


The Hospital Anxiety and Depression Scale ( HADS ) has been recommended internationally for screening .


The Common Mental Disorder Questionnaire ( CMDQ ) is a novel Danish instrument recommended for use in general practice , but it lacks validation .


The objective of this study was to test the reliability and the convergent validity of the anxiety and depression subscales of the CMDQ and the HADS in patients with IBS .


A total of @ patients with IBS completed the CMDQ and the HADS twice in a year .


Data were analysed with respect to internal consistency ( Cronbach 's alpha ) , agreement on case identification ( ) and correlation between scores ( Spearman 's rank correlation coefficient ) .


All subscales showed satisfactory internal consistency .


Cases identified by the CMDQ 's anxiety and depressions subscales differed considerably from those identified with the HADS with only fair-moderate agreement , while the correlation between the scores on the CMDQ and the HADS was only moderate for both anxiety and depressions .


The subscales for anxiety disorder and depression on the CMDQ showed internal consistency , but only fair to moderate agreement and correlation , which yielded an unsatisfying convergent validity compared to the HADS .


More studies in different populations and research on the cut-off values for possible cases could make the CMDQ more useful .


Delayed ischemic neurological deficits ( DINDs ) are a major contributing factor for poor outcome in patients with subarachnoid hemorrhage .


In this trial , we investigated the therapeutic potential of prostacyclin , an endogen substance with known effect on vascular tone and blood flow regulation , on factors related to DIND .


This trial is a single-center , randomized , blinded , clinical , pilot trial with @ arms .


Ninety patients were randomized to continuous infusion of prostacyclin @ ng/kg per minute , prostacyclin @ ng/kg per minute , or placebo .


The intervention was initiated day @ after subarachnoid hemorrhage and discontinued day @ .


Primary outcome was the difference in change from baseline in global cerebral blood flow .


Secondary outcome measures were occurrence of DIND , angiographic vasospasm , and clinical outcome at @ months .


No statistically significant difference in change of global cerebral blood flow was found between the intervention groups .


The observed incidence of DIND and angiographic vasospasm was markedly higher in the placebo group , although this difference was not statistically significant .


No statistically significant differences in safety parameters or clinical outcome were found between the @ groups .


Administration of prostacyclin to patients with subarachnoid hemorrhage may be safe and feasible .


Global cerebral blood flow after subarachnoid hemorrhage is not markedly affected by administration of prostacyclin in the tested dose range .


It may be possible that the observed reduction in the point estimates of DIND and vasospasm in the prostacyclin groups represents an effect of prostacyclin as this trial was not powered to investigate the effect of prostacyclin on these outcomes .


Although the use of drug-eluting stents ( DESs ) in patients with coronary artery disease has contributed to a significant reduction in in-stent restenosis and repeat revascularization , treating diffuse long lesions using DESs remains challenging due to the high rates of in-stent restenosis and stent thrombosis .


Intravascular ultrasound ( IVUS ) provides tomographic images of coronary vascular structure and is useful for evaluating lesion morphology and stent optimization during percutaneous coronary intervention .


However , it remains controversial whether IVUS guidance in DES implantation for long coronary lesions could reduce adverse clinical outcomes .


We hypothesize that the long-term clinical outcomes of IVUS-guided DES implantation would be superior to those of angiography-guided DES implantation in a subset of patients with long coronary lesions .


This study is a randomized , prospective , multi-center trial comparing the long-term clinical outcomes of IVUS-guided and angiography-guided everolimus-eluting stent implantation in patients with long coronary lesions ( implanted stent @ mm in length ) .


The primary end point is a composite of major adverse cardiac events , including cardiac death , target lesion-related myocardial infarction , or target lesion revascularization at @ year following intervention .


A total of @,@ patients will be required to be enrolled according to sample size calculations .


This study will test the hypothesis that IVUS guidance improves long-term clinical outcomes in patients treated with everolimus-eluting stents for long coronary lesions compared with angiographic guidance .


Constipation has been identified as a worldwide health problem among elderly people .


Currently , it is not effectively relieved by the use of laxatives and lifestyle modification .


Previous studies reported promising results in managing constipation with auricular acupressure ( AA ) , although its effectiveness was not affirmed .


This study is to evaluate the complementary effects of AA in relieving constipation symptoms and in promoting disease-specific health-related quality of life ( HRQOL ) among elderly residential care home ( RCH ) residents in Hong Kong .


Randomized placebo-controlled trial .


Elderly RCH .


Ninety-nine participants were randomly assigned to either experimental group ( AA using auricular plasters with magnetic pellets ) , placebo-controlled group ( AA using auricular plasters with Semen Vaccariae ) , or usual care group ( AA using auricular plasters only ) .


AA was applied onto seven auricular acupoints for @ days .


Constipation symptoms and disease-specific HRQOL were measured before AA , at the completion of AA ( D@ ) , and at the @th-day follow-up time ( D@ ) .


Significant grouptime interaction effect was found in the change of satisfaction subscale between the experimental group and placebo-controlled group at D@ ( p = @ ) and D@ ( p = @ ) relative to the baselines .


For both constipation symptoms and disease-specific HRQOL , the experimental group demonstrated the greatest improvement after receiving AA at both D@ and D@ compared with the other two groups .


The current findings indicated positive clinical value of AA with magnetic pellets in managing constipation in elderly RCH residents .


AA was also found to be a safe and acceptable intervention .


The myeloid-related proteins @ and @ ( MRP-@ / MRP-@ ) and neutrophil-derived S@A@ are biomarkers of inflammation .


They can be used to determine the relapse risk in patients with juvenile idiopathic arthritis ( JIA ) after stopping antiinflammatory treatment .


In this study , we tested the performance of different enzyme-linked immunosorbent assays ( ELISAs ) in order to validate systems available for routine use .


MRP-@ / MRP-@ and S@A@ serum concentrations of @ JIA patients in remission were analyzed .


Commercially available test systems were compared to experimental ELISAs established in house .


The ability of the assays to identify JIA patients at risk for relapse was analyzed .


For MRP-@ / MRP-@ , the PhiCal Calprotectin and Buhlmann MRP@/@ Calprotectin ELISAs revealed hazard ratios of @ and @ , respectively .


For S@A@ , the CircuLex S@A@/EN-RAGE ELISA revealed a hazard ratio of @ .


The commercial assays allowed a JIA relapse prediction that was at least comparable to the experimental ELISAs .


For the prediction of JIA relapse after stopping medication , the biomarkers MRP-@ / MRP-@ and S@A@ can be determined by using assays that are available for routine use .


The tested commercial MRP-@ / MRP-@ and S@A@ ELISAs showed a performance comparable to well-established experimental ELISA protocols when assay-specific cutoffs for the indication of relapse prediction are thoroughly applied .


The efficacy and safety of long-acting - agonists ( LABAs ) have been questioned .


Black populations may be disproportionately affected by LABA risks .


To compare the effectiveness and safety of tiotropium vs LABAs , when used with inhaled corticosteroids ( ICS ) in black adults with asthma and to determine whether allelic variation at the Arg@Gly locus of the @-adrenergic receptor ( ADRB@ ) geneis associated with treatment response .


A multisite ( n = @ ) , open-label , parallel-group , pragmatic randomized clinical trial conducted from March @ through July @ , enrolling black adults with moderate to severe asthma in the United States .


Patients eligible for , or receiving , step @ or step @ combination therapy per National Heart , Lung , and Blood Institute guidelines , received ICS plus either once-daily tiotropium ( n = @ ) or twice-daily LABAs ( n = @ , ) and were followed up for up to @ months .


Patients underwent genotyping , attended study visits at baseline , @ , @ , @ , and @ months , and completed monthly questionnaires .


The primary outcome was time to asthma exacerbation , defined as a worsening asthma event requiring oral or parenteral corticosteroids .


Secondary outcomes included patient-reported outcomes ( Asthma Quality of Life Questionnaire , Asthma Control Questionnaire -LSB- ACQ -RSB- , Asthma Symptom Utility Index , and Asthma Symptom-Free Days questionnaire ) , spirometry ( FEV@ ) , rescue medication use , asthma deteriorations , and adverse events .


There was no difference between LABA+ICS vs tiotropium + ICS in time to first exacerbation ( mean No .


of exacerbations/person-year , @ vs @ ( rate ratio , @ -LSB- @ % CI , @ to @ -RSB- , log-rank P = @ ) .


There was no difference in change in FEV@ at @ months ( @ L for LABA+ICS vs -@ L for tiotropium + ICS ; between-group difference , @ -LSB- @ % CI , -@ to @ -RSB- , P = @ ) and at @ months ( -@ L vs -@ L ; between-group difference , @ -LSB- @ % CI , -@ to @ -RSB- , P = @ ) .


There were no differences in ACQ score at @ months ( change in score from baseline , -@ for LABA+ICS vs -@ for tiotropium + ICS ; between-group difference , @ -LSB- @ % CI , -@ to @ -RSB- , P = @ ) .


There were no differences in other patient-reported outcomes .


Arg@Gly ADRB@ alleles were not associated with differences in the effects of tiotropium + ICS vs LABA+ICS ( hazard ratio for time to first exacerbation , @ -LSB- @ % CI , @ to @ -RSB- for Arg/Arg vs @ -LSB- @ % CI , @ to @ -RSB- for Arg/Gly or Gly/Gly , P = @ ) .


Among black adults with asthma treated with ICS , adding a LABA did not improve time to asthma exacerbation compared with adding tiotropium .


These findings were not affected by polymorphisms at the Arg@Gly locus of ADRB@ .


These findings do not support the superiority of LABA+ICS compared with tiotropium + ICS for black patients with asthma .


Endoscopic and clinical recurrence of Crohn 's disease ( CD ) appears in up to @ and @ % of patients , respectively , @ year after surgery .


Both infliximab ( IFX ) and adalimumab ( ADA ) have been demonstrated to be effective in reducing the possibility of recurrence after surgery , but head-to-head studies have not been performed so far .


The aim of this open-label prospective study was to compare endoscopic , histological and clinical recurrence after @ year of treatment with IFX or ADA as postoperative prophylaxis in CD patients with a high risk of recurrence .


Consecutive CD patients who underwent curative ileocolonic resection were randomized to receive IFX or ADA for @ year .


Co-primary endpoints were endoscopic , histological and clinical recurrence after @ months of therapy .


Twenty consecutive CD patients ( @ males and @ females ; median age @ years , range @-@ years ) were enrolled after undergoing curative ileocolonic resection .


Among the @ patients treated with IFX , @ ( @ % ) had endoscopic recurrence compared to @ ( @ % ) in the group of @ ADA patients ( p = @ ) .


Three out of @ ( @ % ) IFX patients and @ out of @ ( @ % ) ADA patients had histological recurrence ( p = @ ) .


No significant clinical differences were found between the two groups .


IFX and ADA were similar in preventing histological , endoscopic and clinical recurrence after curative ileocolonic resection in high risk CD patients .


Growth impairment is a known complication of sickle cell disease .


Effects of hydroxyurea ( HU ) on growth in very young children are not known .


Height , weight , BMI , and head circumference ( HC ) were compared with World Health Organization ( WHO ) standards in BABY HUG , a multicenter , randomized , double-blinded , placebo-controlled @-year clinical trial of HU in @ children @ to @ months of age .


Anthropometric data were closely monitored and converted to z scores by using WHO standardized algorithms for descriptive analyses .


The treatment and placebo groups were compared longitudinally by using a mixed model analysis .


At entry , the z scores of BABY HUG children were higher than WHO norms .


After @ years of HU or placebo treatment , there were no significant differences between the groups , except for the mean HC z scores at study exit ( HU : +@ versus placebo : +@ , P = @ ) .


Baseline z scores were the best predictors of z scores at study exit .


The absolute neutrophil count , absolute reticulocyte count , and total white blood cell count had significant negative correlations with growth measures .


Both groups had normal or near normal anthropometric measures during the study .


The HC z scores at study entry and exit were slightly greater than WHO norms .


Higher baseline white blood cell count , absolute reticulocyte count , and absolute neutrophil count were associated with poorer growth .


The significance of the slightly lower HC in the treatment group at study exit is not clear .


Trends toward normalization of weight and height and effects on HC will be monitored in ongoing BABY HUG follow-up studies .


Intraoperative recruitment manoeuvres ( RMs ) combined with PEEP reverse the decrease in functional residual capacity ( FRC ) associated with anaesthesia and improve intraoperative oxygenation .


Whether these benefits persist after operation remains unknown .


We tested the hypothesis that intraoperative RMs associated with PEEP improve postoperative spirometry including FRC and reduce the incidence of postoperative hypoxaemia in morbidly obese ( MO ) patients undergoing laparoscopic gastric bypass .


After IRB approval and informed consent , @ MO patients undergoing laparoscopic gastric bypass under volume-controlled ventilation ( tidal volume @ ml kg ( -@ ) of IBW ) were randomly ventilated with either @ cm HO PEEP or with @ cm HO PEEP and one RM carried out after induction of pneumoperitoneum , and another after exsufflation .


Anaesthesia and analgesia were standardized .


Spirometry was assessed before operation and @ h after surgery .


Postoperative oxygenation and the apnoea-hypopnoea index ( AHI ) were recorded during the first postoperative night .


Age , BMI , and STOP BANG score were similar in both groups .


FRC decrease after surgery was minimal -LSB- @ ( @ ) litre in control and @ ( @ ) litre in the RM group -RSB- and similar between the groups ( P = @ ) .


FVC , FEV@ , mean -LSB- Formula : see text -RSB- , percentage of time spent with -LSB- Formula : see text -RSB- below @ % , and AHI did not differ significantly between the groups .


This study demonstrates that when added to a protective mechanical ventilation combining low tidal volume and high PEEP , two RMs do not improve postoperative lung function including FRC , arterial oxygenation , and the incidence of obstructive apnoea in MO patients after laparoscopic upper abdominal surgery .


Colorectal stents have been available as a management option in obstruction for @ years , yet there is little randomized evidence of their effectiveness .


This study investigated current surgeon-related barriers to conducting a randomized , controlled trial ( RCT ) of colorectal stent insertion for obstruction in patients with colorectal cancer .


A binational survey of current members of the Colorectal Surgical Society of Australia and New Zealand was conducted by a mailed questionnaire assessing perceived barriers to adoption of colonic stents and willingness to participate in future multicentre randomized controlled trials , and surgeons ' treatment preferences in @ hypothetical clinical scenarios .


Of @ eligible surgeons , @ ( @ % ) responded .


Colonic stenting was available to @ % of respondents .


In the clinical setting of colorectal obstruction , only @ % ( @ % CI , @-@ % ) of surgeons expressed a willingness to participate in a RCT involving colonic stents in the curative setting .


More than @ % of surgeons preferred the use of stents in unfit patients for palliation , and preferred surgery in fit patients with curable disease .


In the curative setting , most respondents considered colonic stents not cost effective ( @ % ; @ % CI , @-@ % ) and believed that their patients would not prefer stents over surgery ( @ % ; @ % CI , @-@ % ) .


This study highlights the limitation to conducting a future randomized controlled trial to assess the efficacy of colonic stenting , especially in the curative setting , based on surgeon preference , despite the lack of level I evidence .


The aim of this multicenter , prospective , randomized , crossover trial is to compare , in critical care patients receiving insulin infusion therapy ( IIT ) , the pharmacodynamic of Humulin insulin ( Hlin ) , currently used as `` standard of care , '' and Humalog insulin ( Hlog ) , a shorter acting insulin formulation .


This was measured as extent and duration of the carryover effect of insulin treatment , with the latter calculated as ratio between blood glucose concentration ( BGC ) reduction during and after IIT .


Twenty-eight patients treated in an intensive care unit and receiving full nutritional support were randomly assigned to Hlin or Hlog as first treatment .


Insulin was infused at a constant rate in patients presenting with BGC greater than or equal to @ mg/dL ( @ U/kg per hour ) and was discontinued when BGC was less than or equal to @ mg/dL ( therapeutic BGC drop ) .


Further reductions in BGC after discontinuation of insulin infusion were recorded ( postinfusional BGC drop ) .


During the study period , whole blood BGC was measured every @ minutes .


A minimal @-hour washout interval was maintained between treatments with the @ types of insulin .


The primary end point was the extent ( calculated as ratio between the therapeutic BGC drop and the postinfusional BGC drop ) and duration of the carryover effect .


Treatment with Hlog , as compared with Hlin , was associated with a less profound carryover effect as well as a briefer duration of carryover ( median , @ vs @ ; P < @ ; median , @ vs @ hours ; P < @ ) .


The use of constant Hlog infusion for IIT , when compared with Hlin at the same dose , is associated with a less profound carryover effect on BGC after discontinuation of IIT , a briefer duration of carryover , a faster BGC drop during infusion , and a quicker BGC rise after discontinuation .


These characteristics suggest that Hlog IIT may be preferable for use in critically ill patients .


Understanding peer effect is potentially important for finding ways to combat the obesity epidemic .


Nevertheless , it is not clear whether a peer effect exists because of the composition of the peer group , because the group members have similar , unobserved individual characteristics , or because of an endogenous effect .


This issue is addressed here by using a unique longitudinal data set of @ schoolchildren attending state schools in the Municipality of Aalborg , Denmark , during @-@ .


To identify the spillover effect of a targeted intervention on peers , we use a difference-in-differences approach .


A targeted health intervention reduced body mass index ( BMI ) among overweight , inactive individuals and , more interestingly , that BMI among the nontreated peers was reduced by @ % .


The analysis suggests that individually targeted health intervention has a health benefit beyond the treated individual , which needs to be included when evaluating targeted policies aiming to combat childhood overweight and inactivity .


To determine the effect of Parkinson 's disease-weight bearing exercise for better balance ( PD-WEBB ) exercise on balance impairment and falls in people with Parkinson 's disease ( PD ) .


A single-blind , randomized controlled clinical trial was conducted .


The falls efficacy scale score , unified Parkinson disease rating scale ( UPDRS ) score and Mini-BESTest score were measured and compared between a PD-WEBB group and a control group .


The falls efficacy scale score , UPDRS-@ score , UPDRS-@ score and Mini-BESTest score were improved in the PD-WEBB group compared with the control group ( P < @ ) , with no significant change in UPDRS-@ score between the two groups .


PD-WEBB training can significantly improve the balance impairment and quality of life to prevent falls .


PD-WEBB training is suitable for PD patients in China , and is a reasonable , effective and sustainable training of family and community assessment model .


Hypertension is a major , modifiable risk factor for cardiovascular and kidney disease and premature mortality that is improved by the DASH ( Dietary Approaches to Stop Hypertension ) diet .


The DASH diet emphasizes increased consumption of fruit and vegetables , whole grains , low-fat dairy , nuts , and poultry and fish and reduced intakes of fats , red meats ( including pork ) , sodium , and added sugars .


We sought to evaluate whether the consumption of lean pork compared with the consumption of chicken and fish as the predominant protein source in a DASH-style diet affected blood pressure ( BP ) control in men and women with elevated BP .


In a randomized crossover study , @ women and @ men -LSB- mean SEM age : @ @ y ; BMI ( in kg/m ) : @ @ -RSB- with elevated BP -LSB- systolic blood pressure ( SBP ) / diastolic blood pressure ( DBP ) : @ @/@ @ mm Hg -RSB- consumed a DASH-style diet for two @-wk controlled dietary interventions ( with a @-wk diet washout between interventions ) with either lean pork -LSB- DASH diet with pork ( DASH-P ) -RSB- or chicken and fish -LSB- DASH diet with chicken and fish ( DASH-CF ) , the control diet -RSB- as the major protein source ( @ % of total protein intake ) .


SBP and DBP were measured manually and with a @-h BP monitoring system on @ d before and @ d at the end of each diet intervention .


Preintervention manual BP ( DASH-P : @/@ @/@ mm Hg ; DASH-CF : @/@ @/@ mg Hg ) and postintervention manual BP ( DASH-P : @/@ @/@ mm Hg ; DASH-CF : @/@ @/@ ) were not different between the DASH-P and DASH-CF .


Consumption of these DASH-style diets for @ wk reduced all measures of BP ( P < @ ) with no differences in responses between the DASH-CF and DASH-P .


The results indicate that adults with elevated BP may effectively incorporate lean pork into a DASH-style diet for BP reduction .


Percutaneous pins used in the surgical fixation of fractures in children are often removed in the outpatient clinic without the administration of analgesia .


Pin removal can be a cause of anxiety for children , parents , and caregivers .


Relatively little is known about the requirement of analgesia for this procedure .


In a randomized controlled trial , we evaluated whether oral acetaminophen or ibuprofen reduced the pain experienced during pin removal .


Participating in the study were @ children between the ages of five and twelve years who had two or three percutaneous pins in the elbow following treatment of a supracondylar humeral fracture or a lateral humeral condyle fracture with closed reduction and percutaneous pinning .


The patients were randomized into one of three groups ( n = @ ) allocated to receive acetaminophen , ibuprofen , or vitamin C ( placebo ) an hour before pin removal .


A pain score was obtained and heart rate measured before pin removal , immediately following the procedure , and ten minutes after pin removal .


No significant differences were found among the study groups in terms of the demographic data of sex , age , side of injury , or number of pins .


Pain score and heart rate did not exhibit differences that were either statistically significant or clinically relevant .


The change from baseline did not differ significantly among the groups for either measure at either of the follow-up times post pin removal .


Immediately after pin removal , the mean difference in pain score ( and @ % confidence interval -LSB- CI -RSB- ) between the acetaminophen group and the ibuprofen group was @ ( -@ to @ ) ; between the acetaminophen group and the placebo group , @ ( -@ to @ ) ; and between the ibuprofen group and the placebo group , @ ( -@ to @ ) .


The CIs excluded a clinically relevant difference .


Pain scores and heart rates returned to preprocedural baseline levels within ten minutes following pin removal .


Neither acetaminophen nor ibuprofen significantly reduced the pain score or heart rate associated with percutaneous pin removal in children as compared with the placebo .


The oral analgesics administered were clinically equivalent to the placebo .


These results suggest that non-narcotic analgesia use does not significantly reduce pain or heart rate associated with percutaneous pin removal in children .


Several studies have suggested that proton-pump inhibitors ( PPIs ) , mostly omeprazole , interact with clopidogrel efficacy by inhibiting the formation of its active metabolite via CYP@C@ inhibition .


Whether this occurs with all PPIs is a matter of debate .


As rabeprazole is a less potent CYP@C@ inhibitor than other PPIs , we studied the interaction between rabeprazole and the antiplatelet actions and pharmacokinetics of clopidogrel .


To demonstrate the non-inferiority of rabeprazole over placebo using change in platelet reactivity index ( PRI ; vasodilator-stimulated phosphoprotein -LSB- VASP -RSB- assay ) in a predefined population of good clopidogrel responders .


Omeprazole was used as the positive control .


In this randomized three-period crossover study in healthy volunteers , @ healthy men received clopidogrel ( @ mg/day for @ days ) with placebo , omeprazole ( @mg/day ) or rabeprazole ( @mg/day ) .


Clopidogrel antiplatelet effects and disposition kinetics were assessed on day @ of combination therapy .


Non-inferiority threshold was predefined as an upper limit of the @ % confidence interval for the difference in change in PRI between placebo and rabeprazole of < @ % in good clopidogrel responders .


In good clopidogrel responders ( inhibition of VASP index > @ % ) , the clopidogrel antiplatelet effect remained non-inferior to placebo during rabeprazole ( difference @ % -LSB- -@ ; @ -RSB- ) but not omeprazole ( difference @ % -LSB- @ ; @ -RSB- ) co-administration .


The AUC@-@ and Cmax of active clopidogrel metabolite decreased with both omeprazole and rabeprazole , and conditions of bioequivalence were not met , except for AUC@-@ with rabeprazole .


Rabeprazole does not interact with clopidogrel to the same extent as omeprazole .


However , under our experimental conditions and proton-pump inhibitor doses , there was no significant pharmacodynamic interaction between rabeprazole or omeprazole and clopidogrel , despite a significant decrease in the formation of clopidogrel active metabolite .


Well-being encompasses physical , psychological , and social aspects of health and predicts healthcare utilization and expenditures .


Despite their potential clinical impact , interventions that leverage social network effects to target well-being are uncommon .


Using a pragmatic design , to evaluate the effectiveness of an online well-being intervention as part of ongoing program development .


Randomized , placebo-controlled , parallel-group trial with longitudinal outcome measurements at baseline , @ days , and @ days .


A total of @ U.S.-based adults were enrolled .


Recruitment , eligibility verification , and baseline data collection were conducted entirely online ; follow-up took place online or by phone .


The study was conducted in @ .


A multimodal e-mail - , web - , and mobile-based intervention ( Daily Challenge ) , in which participants receive daily suggestions of small health actions that they complete in a social environment .


A traditional weekly health newsletter served as control .


Overall well-being as measured by the Individual-level Well-Being Assessment and Scoring Method ( scale : @ to @ ) .


Follow-up rates reached @ % ( n = @ ) at @ days and @ % ( n = @ ) at @ days .


Overall , @ % of treatment group participants visited the website , and @ % opened program e-mails ( vs @ % in the control group ) .


Daily Challenge improved well-being significantly more than control at @ days ( @ points , p = @ ) and at @ days ( @ points , p = @ ) .


A dose response for intensity of use was observed at @ days ( p = @ ) and @ days ( p = @ ) .


Well-being improvement was greater in participants with than without social ties in the program ( at @ days : p = @ ; at @ days : p = @ ) .


A multimodal online intervention leveraging social network effects significantly improved well-being over control .


Higher levels of participation as well as increasing levels of social integration were associated with greater improvement in well-being .


Alcohol is a major global threat to public health .


Although the main burden of chronic alcohol-related disease is in adults , its foundations often lie in adolescence .


Alcohol consumption and related harm increase steeply from the age of @ until @ years .


Several trials focusing upon young people have reported significant positive effects of brief interventions on a range of alcohol consumption outcomes .


A recent review of reviews also suggests that electronic brief interventions ( eBIs ) using internet and smartphone technologies may markedly reduce alcohol consumption compared with minimal or no intervention controls .


Interventions that target non-drinking youth are known to delay the onset of drinking behaviours .


Web based alcohol interventions for adolescents also demonstrate significantly greater reductions in consumption and harm among ` high-risk ' drinkers ; however changes in risk status at follow-up for non-drinkers or low-risk drinkers have not been assessed in controlled trials of brief alcohol interventions .


The study design comprises two linked randomised controlled trials to evaluate the effectiveness and cost-effectiveness of two intervention strategies compared with screening alone .


One trial will focus on high-risk adolescent drinkers attending Emergency Departments ( Eds ) and the other will focus on those identified as low-risk drinkers or abstinent from alcohol but attending the same ED .


Our primary ( null ) hypothesis is similar for both trials : Personalised Feedback and Brief Advice ( PFBA ) and Personalised Feedback plus electronic Brief Intervention ( eBI ) are no more effective than screening alone in alcohol consumed at @ months after randomisation as measured by the Time-Line Follow-Back @-day version .


Our secondary ( null ) hypothesis relating to economics states that PFBA and eBI are no more cost-effective than screening alone .


In total @,@ participants will be recruited into the trials , @ high-risk drinkers and @ low-risk drinkers or abstainers .


Participants will be randomised with equal probability , stratified by centre , to either a screening only control group or one of the two interventions : single session of PFBA or eBI .


All participants will be eligible to receive treatment as usual in addition to any trial intervention .


Individual participants will be followed up at @ and @ months after randomisation .


The protocol represents an ambitious innovative programme of work addressing alcohol use in the adolescent population .


Inflammation is associated with progression of chronic heart failure ( HF ) .


Few data exist on high-sensitivity C-reactive protein ( hsCRP ) levels and their importance in acute HF .


In this biomarker substudy of the ASCEND-HF trial , we measured hsCRP levels at admission ( n = @ ) , @-@ hours ( n = @ ) , and @ days ( n = @ ) and evaluated their association with outcomes .


Levels of hsCRP were considerably elevated at admission ( median @ mg/L , interquartile range -LSB- IQR -RSB- @-@ @ ) and @-@ hours ( median @ mg/L , IQR @-@ @ ) and declined only at @ days ( median @ mg/L , IQR @-@ @ ) .


Admission hsCRP was not associated with dyspnea improvement at @ hours ( @ % ) and @ hours ( @ % ) , in-hospital death or worsening HF ( n = @ ; @ % ) , @-day mortality or HF readmission ( death : n = @ -LSB- @ % -RSB- ; combined death and HF readmission : n = @ -LSB- @ % -RSB- ) , or @-day mortality ( n = @ ; @ % ) .


Hospital stay ( median @ days , IQR @-@ ) was longer among patients with higher admission hsCRP levels ( @ days per log@-hsCRP in adjusted models ; @ % confidence interval -LSB- CI -RSB- @-@ @ ; P < @ ) .


Levels of hsCRP at @-@ hours did not predict @-day mortality or HF readmission and were only marginally associated with @-day mortality .


However , higher hsCRP at @ days among survivors was associated with higher @-day mortality in models including admission hsCRP ( adjusted hazard ratio -LSB- HR -RSB- per log@-hsCRP : @ ; @ % CI @-@ @ ; P = @ ) .


Patients with an hsCRP increase at day @ , defined as > @ % increase over baseline value , had higher @-day mortality risk compared with those with unchanged or decreased @-day hsCRP ( HR @ , @ % CI @-@ @ ; P = @ ) .


Levels of hsCRP are elevated among patients with acute HF .


Increasing levels at @ days after discharge are associated with higher @-day mortality .


To evaluate the clinical effect on plaque metabolism of a dentifrice containing @ % arginine , an insoluble calcium compound and @,@ ppm fluoride compared to a commercially available dentifrice containing @,@ ppm fluoride in a silica base .


A @-week , parallel , randomized , double-blind study using @ subjects was conducted at the Colgate-Palmolive Technology Center ( Piscataway , NJ , USA ) .


One group used a test dentifrice containing @ % arginine , an insoluble calcium compound and @,@ ppm fluoride as sodium monofluorophosphate ( MFP ) , and the other group used a commercial silica dentifrice with @,@ ppm fluoride as sodium fluoride ( NaF ) as a control .


Plaque metabolism analyses were conducted at baseline and after @ , @ , @ , @ , and @ weeks of assigned product use .


The plaque analyses included pH measurements before and after a sucrose rinse , ammonia production and lactic acid production .


Subjects using the test dentifrice had significantly higher plaque pH values before ( P < or = @ ) and after ( P < or = @ ) a sucrose challenge than those using the commercially available control dentifrice .


Subjects using the test dentifrice also produced higher levels of ammonia and lower levels of lactic acid compared to subjects using the control dentifrice .


Current guidelines recommend the use of low molecular weight heparin ( LMWH ) for most haemodynamically stable patients with pulmonary thromboembolism ( PTE ) , however , it is not clear whether LMWH is preferable to unfractionated heparin ( UFH ) for the treatment of massive PTE .


We aimed to compare the use of LMWH versus UFH after thrombolytic treatment in the management of acute massive PTE for hemorrhage and hospital mortality .


The study , a randomized , single center , parallel design trial , included the patients who had confirmed the diagnosis of massive PTE according to clinical findings and computerized thorax angiography and no contraindication to the treatment between January @ and October @ .


After thrombolytic treatment , the patients assigned to therapy with LMWH or UFH .


Any hemorrhage , major hemorrhage , and hospital mortality were assessed .


A total of @ patients , @ female ( @ % ) and @ male ( @ % ) , who had massive PTE with an average age @ @ ( ranges @-@ ) were included for analyses in the study .


They were allocated to either LMWH ( n = @ ) or UFH ( n = @ ) group .


Although the occurrence of any adverse event ( @ vs @ % ) and each individual type of adverse event were all lower in the LMWH group compared to UFH group ( @ vs @ % , @ vs @ % , and @ vs @ % for death , major hemorrhage , and any hemorrhage , respectively ) , the differences were not statistically significant .


Our findings suggest that LMWH might be a better option in the management of the patients with massive PTE .


Multi-center larger randomized controlled trials are required to confirm our results .


The CALORIES trial is a pragmatic , open , multicentre , randomised controlled trial ( RCT ) of the clinical effectiveness and cost-effectiveness of early nutritional support via the parenteral route compared with early nutritional support via the enteral route in unplanned admissions to adult general critical care units ( CCUs ) in the United Kingdom .


The trial derives from the need for a large , pragmatic RCT to determine the optimal route of delivery for early nutritional support in the critically ill .


To describe the proposed statistical analyses for the evaluation of the clinical effectiveness in the CALORIES trial .


With the primary and secondary outcomes defined precisely and the approach to safety monitoring and data collection summarised , the planned statistical analyses , including prespecified subgroups and secondary analyses , were developed and are described .


The primary outcome is all-cause mortality at @ days .


The primary analysis will be reported as a relative risk and absolute risk reduction and tested with the Fisher exact test .


Prespecified subgroup analyses will be based on age , degree of malnutrition , acute severity of illness , mechanical ventilation at admission to the CCU , presence of cancer and time from CCU admission to commencement of early nutritional support .


Secondary analyses include adjustment for baseline covariates .


In keeping with best trial practice , we have developed , described and published a statistical analysis plan for the CALORIES trial and are placing it in the public domain before inspecting data from the trial .


To compare different techniques of minimally invasive surgery ( laparoscopy and robotics ) to abdominal surgery in order to identify the optimal surgical technique in the treatment of endometrial cancer .


A single-institutional , matched , retrospective , cohort study was performed .


All patients with clinical stage I or occult stage II endometrial cancer who underwent robotic hysterectomy , bilateral salpingo-oophorectomy lymphadenectomy from August @ and December @ were identified .


Surgical and oncological outcomes were compared with patients matched by age , body mass index , tumor histology , and grade , who underwent abdominal or laparoscopic surgery between January @ and December @ .


Three groups were identified : @ laparotomies ( group A ) , @ laparoscopies ( group B ) and @ robotics ( group C ) .


There were no statistically significant differences between the three groups in terms of age , BMI and FIGO stage .


The operative time was shortest in group B ( p = @ ) .


Blood loss and transfusions were equivalent in group B and C , while they were greater in group A ( p = @ ) .


The intra-operative , early and late postoperative complications , rate of conversion , the re-intervention and median hospital stay were lower in group C.


The rate of recurrence and death from disease was similar in all three groups .


Minimally invasive surgery was superior to abdominal surgery in terms of surgical outcomes .


Robotic surgery was superior to laparoscopy in terms of intra - and post-operative complications , conversion rates , length of hospital stay and re-interventions .


In terms of oncological outcomes the three groups were equivalent .


Tacrolimus is an effective ( but relatively expensive ) immunosuppressant that is used widely in patients with membranous nephropathy .


To reduce the tacrolimus dose while maintaining an equivalent therapeutic effect , we studied the clinical efficacy and pharmacoeconomic impact of co-administration of Wuzhi capsules ( WZC that protects against damage to liver cells ) and tacrolimus .


Sixty patients with membranous nephropathy were divided randomly into two groups : experimental ( tacrolimus + WZC + corticosteroids ) and control ( tacrolimus + corticosteroids ) .


Each group received treatments continuously for > @ months .


Liver function ; renal function ; and whole-blood concentrations of tacrolimus , sugars , lipids , as well as @-h urinary protein levels were used in the clinical evaluation .


The cost of drugs was calculated , and the pharmacoeconomic cost-effectiveness analyses were carried out to compare indices between the two groups .


Doses and costs of tacrolimus differed significantly between experimental and control groups ( p < @ or p < @ ) .


Costs in the experimental group were @,@ @,@ CNY ( @,@ @ USD ) and those in the control group were @,@ @,@ CNY ( @,@ @ USD ) , with clinical efficacy of @ and @ % , respectively .


The cost-effectiveness ratios were @ @ and @ @ , respectively .


Compared with the experimental group , the control group showed an incremental cost-effectiveness ratio of @,@ @ CNY ( @ @ USD ) , whereas remission between the two groups was similar .


Co-administration of WZCs and tacrolimus can reduce the dose of tacrolimus and decrease the costs incurred by patients within the same therapeutic window to that seen for treatment with tacrolimus alone .


This phase III trial aimed to confirm the superiority of weekly docetaxel and cisplatin over docetaxel monotherapy in elderly patients with advanced non-small-cell lung cancer ( NSCLC ) .


Chemotherapy-nave patients with stage III , stage IV , or recurrent NSCLC age @ years with a performance status of @ or @ who were considered unsuitable for bolus cisplatin administration were randomly assigned to receive docetaxel @ mg/m ( @ ) on day @ , every @ weeks , or docetaxel @ mg/m ( @ ) plus cisplatin @ mg/m ( @ ) on days @ , @ , and @ , every @ weeks .


The primary end point was overall survival ( OS ) .


In the first interim analysis , OS of the doublet arm was inferior to that of the monotherapy arm ( hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @ to @ ) , and the predictive probability that the doublet arm would be statistically superior to the monotherapy arm on final analysis was @ % , which led to early study termination .


In total , @ patients with a median age of @ years ( range , @ to @ years ) were enrolled .


At the updated analysis , the median survival time was @ months for the monotherapy arm and @ months for the doublet arm ( HR , @ ; @ % CI , @ to @ ) .


The rates of grade @ neutropenia and febrile neutropenia were higher in the monotherapy arm , and those of anorexia and hyponatremia were higher in the doublet arm .


This study failed to demonstrate any survival advantage of weekly docetaxel plus cisplatin over docetaxel monotherapy as first-line chemotherapy for advanced NSCLC in elderly patients .


Active video games ( AVGs ) have been shown to acutely increase energy expenditure when compared with seated video games ; however , the influence of AVGs on compensatory adjustments in energy intake and expenditure is largely unknown .


The aim was to examine the acute effects of AVGs on energy intake and expenditure .


With the use of a randomized crossover design , @ male adolescents ( mean SD age : @ @ y ) completed three @-h experimental conditions : resting control , seated video game play ( Xbox @ ; Microsoft ) , and AVG play ( Kinect Adventures on Xbox @ ) followed by an ad libitum lunch .


A validated food menu was used to assess food intake immediately after the conditions and for the remainder of the day , and a dietary record was used for the subsequent @-d period .


Energy expenditure was measured by using portable indirect calorimetry throughout each experimental condition , and an accelerometer was used to assess the subsequent @-d period .


Appetite sensations were assessed by using visual analog scales at different time points during the testing day .


The primary outcomes were acute ( immediately after the conditions and @-h ) and short-term ( @-d ) energy intake and expenditure .


Energy expenditure was significantly higher ( ~ @ % ; P < @ ) during the AVG condition than during the resting control and seated video game conditions ; however , no significant differences in energy expenditure were observed @ h ( ~ @ % ; P > @ ) and @ d after the experimental conditions ( ~ @ % ; P > @ ) .


No significant differences were observed in absolute energy intake immediately after the conditions ( ~ @ % ; P > @ ) or in absolute energy intake @ h ( ~ @ % ; P > @ ) and @ d ( ~ @ % ; P > @ ) after the experimental conditions .


Finally , appetite sensations were similar between conditions at all time points ( P > @ ) .


The increase in energy expenditure promoted by a single session of Kinect AVG play is not associated with increased food intake but is compensated for after the intervention , resulting in no measurable change in energy balance after @ h.


These results suggest that the potential of Kinect to reduce the energy gap underlying weight gain is offset within @ h in male adolescents .


This trial was registered at clinicaltrials.gov as NCT@ .


Ipilimumab is a fully human monoclonal antibody that binds cytotoxic T-lymphocyte antigen @ to enhance antitumour immunity .


Our aim was to assess the use of ipilimumab after radiotherapy in patients with metastatic castration-resistant prostate cancer that progressed after docetaxel chemotherapy .


We did a multicentre , randomised , double-blind , phase @ trial in which men with at least one bone metastasis from castration-resistant prostate cancer that had progressed after docetaxel treatment were randomly assigned in a @:@ ratio to receive bone-directed radiotherapy ( @ Gy in one fraction ) followed by either ipilimumab @ mg/kg or placebo every @ weeks for up to four doses .


Non-progressing patients could continue to receive ipilimumab at @ mg/kg or placebo as maintenance therapy every @ months until disease progression , unacceptable toxic effect , or death .


Patients were randomly assigned to either treatment group via a minimisation algorithm , and stratified by Eastern Cooperative Oncology Group performance status , alkaline phosphatase concentration , haemoglobin concentration , and investigator site .


Patients and investigators were masked to treatment allocation .


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


This trial is registered with ClinicalTrials.gov , number NCT@ .


From May @ , @ , to Feb @ , @ , @ patients were randomly assigned ( @ to ipilimumab and @ to placebo ) , all of whom were included in the intention-to-treat analysis .


Median overall survival was @ months ( @ % CI @-@ ) with ipilimumab and @ months ( @-@ ) with placebo ( hazard ratio -LSB- HR -RSB- @ , @-@ ; p = @ ) .


However , the assessment of the proportional hazards assumption showed that it was violated ( p = @ ) .


A piecewise hazard model showed that the HR changed over time : the HR for @-@ months was @ ( @ % CI @-@ ) , for @-@ months was @ ( @-@ ) , and beyond @ months was @ ( @-@ ) .


The most common grade @-@ adverse events were immune-related , occurring in @ ( @ % ) patients in the ipilimumab group and @ ( @ % ) of patients in the placebo group .


The most frequent grade @-@ adverse events included diarrhoea ( @ -LSB- @ % -RSB- of @ patients in the ipilimumab group vs seven -LSB- @ % -RSB- of @ in the placebo group ) , fatigue ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , anaemia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , and colitis ( @ -LSB- @ % -RSB- vs @ ) .


Four ( @ % ) deaths occurred because of toxic effects of the study drug , all in the ipilimumab group .


Although there was no significant difference between the ipilimumab group and the placebo group in terms of overall survival in the primary analysis , there were signs of activity with the drug that warrant further investigation .


Dersalazine sodium is an inhibitor of platelet activator factor with potential efficacy in patients with ulcerative colitis through an alternative mechanism of action .


The study was a first proof of clinical safety and activity of dersalazine sodium in patients with ulcerative colitis .


A double-blind study of randomized patients with ulcerative colitis ( Mayo score @ and @ , including a sigmoidoscopy subscore @ ) to dersalazine sodium @ mg/@ h , mesalazine @ mg/@ h , or placebo for @ weeks .


Mayo scores were calculated on week @ ( partial Mayo ) and week @ ( full Mayo ) .


All patients received open-label mesalazine for @ additional weeks , and a final visit was done at week @ .


The study included @ patients ( @ dersalazine sodium , @ mesalazine , and @ placebo ) .


Clinical remission was observed in @ % patients treated with dersalazine sodium versus @ % in mesalazine and @ % in placebo after @ weeks of treatment .


Colon biopsies showed significantly decreased expression of inflammatory genes in dersalazine sodium patients .


Adverse events at least possibly related to treatment were observed in @ % , @ % , and @ % of patients receiving dersalazine sodium , mesalazine , and placebo , respectively ; no serious adverse reactions were reported .


Increased liver enzymes were reported in @/@ patients receiving dersalazine sodium , with normal bilirubin levels ; both returned to normal values on treatment interruption .


Studies in wider populations are needed to confirm the clinical activity of dersalazine sodium .


Weekly measurements of liver function tests may be necessary for early detection of adverse events .


This study tested the hypothesis that the antidepressant venlafaxine would be an effective treatment for cocaine abusers with concurrent depressive disorders .


This was a randomized , @-week , double-blind , placebo-controlled trial of outpatients ( N = @ ) meeting DSM-IIIR criteria for cocaine dependence and major depression or dysthymia ( by SCID interview ) .


Participants were treated with venlafaxine , up to @mg/day versus placebo .


All patients received weekly individual manual-guided relapse prevention therapy .


Weekly outcome measures included Clinical Global Impression Scale ( CGI ) , self-reported cocaine use , urine toxicology and the Hamilton Depression Scale ( Ham-D ) .


Mood response , defined as a @ % reduction in the Ham-D between randomization and end of study , was @ % ( @/@ ) on venlafaxine , and @ % ( @/@ ) on placebo ( p = @ ) .


Measures of depression ( Ham-D and CGI ) improved more rapidly on venlafaxine than placebo , but these differences disappeared by weeks @-@ .


Cocaine outcomes did not differ between treatment groups , and the proportion of patients achieving three or more consecutive weeks of urine-confirmed abstinence was low ( venlafaxine : @ % ; placebo : @ % ) .


Reduction in cocaine use was associated with mood response .


Overall , venlafaxine was not superior to placebo on either mood or cocaine use outcomes .


Mood improvement was associated with improvement in cocaine use .


However , placebo mood response was only moderate , and the proportion of patients achieving sustained abstinence was low .


This suggests that the subgroup of cocaine-dependent patients with depressive disorders is relatively treatment resistant , and that further research is needed to improve outcomes for these patients .


To investigate the feasibility and preliminary outcomes of a home progressive resistance training ( PRT ) program augmented by neuromuscular electrical stimulation ( NMES ) .


Randomized controlled pilot trial .


Participant homes .


People with multiple sclerosis ( MS ) ( N = @ ) who use a walking aid .


A @-week home PRT program or the same program augmented by NMES .


Strength using hand-held dynamometry ; repeated sit to stand test ; Berg Balance Scale ; timed Up & Go test ; @-Item Multiple Sclerosis Walking Scale ; Multiple Sclerosis Impact Scale-@ , version @ ; and Modified Fatigue Impact Scale ( MFIS ) .


The NMES group also completed a device usability questionnaire .


Only change in MFIS score was significantly greater in the NMES group than the PRT group ( P = @ ) .


The NMES group improved significantly in quadriceps endurance ( median of change , @ ; P = @ ) , balance ( median of change , @ ; P = @ ) , physical impact of MS ( median of change , -@ ; P = @ ) , and impact of fatigue ( median of change , -@ ; P = @ ) .


Participants rated the device as highly usable .


This pilot study suggests that a home PRT program with NMES is feasible , and the neuromuscular electrical stimulation device is usable by this population .


Only reduction in impact of fatigue was greater in the NMES than the PRT group .


Plantarflexion results from the combined action of the soleus and gastrocnemius muscles in the calf .


The heel rise test is commonly used to test calf muscle endurance , function , and performance by a wide variety of professionals ; however , no uniform description of the test is available .


This paper aims to document the construction and reliability of a novel heel rise test device and measurement protocol that is suitable for the needs of most individuals .


This device was constructed from compact and lightweight materials and is fully adjustable , enabling the testing of a wide variety of individuals .


It is easy to assemble and disassemble , ensuring that it is portable for use in different settings .


We tested reliability on @ participants , finding excellent interrater reliability ( ICC@ ,@ @ , @ % CI : @ to @ ) .


Limits of agreement were less than two repetitions in @ % of cases and the Bland-Altman plot showed no bias .


We have designed a novel , standardized , simple , and reliable device and measurement protocol for the heel rise test which can be used by researchers and clinicians in a variety of settings .


Because antileukotrienes may inhibit inflammation , it is plausible that montelukast administered for a long time could suppress skin wheal and flare reaction , and thus , it should be discarded prior to the tests .


This study assessed the effect of long-lasting treatment with montelukast alone or in combination with antihistamines on wheal and flare in skin pricks tests ( SPT ) in patients sensitized to perennial allergens .


We conducted a @-week , double-blind , placebo-controlled , cross-over and randomized trial that implicated two arms : arm A , @ patients received levocetirizine , montelukast with or without levocetirizine or placebo ; arm B , @ patients received desloratadine , montelukast with or without desloratadine or placebo .


All treatment periods lasted @weeks and were separated by @-week washouts .


At baseline and on the last day of each treatment period , SPT were performed in all participants .


Both levocetirizine and desloratadine in monotherapy , or in combination with montelukast , were effective in reducing wheal and flare in SPT .


Monotherapy with montelukast did not change the size of the wheal for either histamine or for house dust mites , in either arm of the study , but significantly reduced the size of flare for histamine in arm A. Addition of montelukast to antihistamine did not exceed efficacy of monotherapy with antihistamine in both arms of the study .


Since the size of wheal determines the results of SPT , montelukast , even taken for a long time , does not have to be discarded prior to the tests .


The objective of this study was to compare image quality ( objective and subjective parameters ) and confidence in lesion detection between @ image reconstruction algorithms in computed tomographic ( CT ) examinations of the abdomen/pelvis .


This prospective institutional review board-approved study included @ patients ( mean -LSB- SD -RSB- age , @ @ years ; mean -LSB- SD -RSB- body mass index , @ -LSB- @ -RSB- kg ) who underwent routine CT examinations of the abdomen/pelvis followed immediately by @ low-dose scans .


Raw data sets were reconstructed by using filtered back projection ( FBP ) , adaptive statistical iterative reconstruction ( ASIR ) , and a model-based iterative reconstruction ( MBIR ) .


Measurements of objective noise and CT numbers were compared using repeated-measures analysis of variance .


Six subjective image quality parameters were scored .


Diagnostic confidence and accuracy in detection of various elementary lesions were performed .


Objectively , mean image noise for MBIR was significantly superior at all dose levels ( P < @ ) .


Subjectively , standard-dose ASIR and low-dose MBIR scans were better than standard-dose FBP scan in all parameters assessed ( P < @ ) .


Low-dose MBIR scans were comparable with standard-dose ASIR scans in all parameters except at noise index of @ ( approximately @ % dose reduction ) , where , in this case , the detection of liver lesions less than @ mm were rated inferior ( P < @ ) with diagnostic accuracy reducing to @ % .


Low-dose MBIR scan shows superior objective noise reduction compared with standard-dose FBP and ASIR .


Subjectively , low-dose MBIR scans at @ % dose reduction were also superior compared with standard-dose FBP and ASIR .


However , at dose reductions of @ % , small liver lesions may be missed .


Ultrasound-guided radiofrequency ablation ( RFA ) of solid thyroid nodules ( TNs ) is a minimally invasive procedure that may induce a volume reduction of symptomatic solid benign TNs .


The aim of the study was to evaluate the effectiveness and safety of RFA in debulking benign TNs .


Eighty-four consecutive patients with symptomatic and cytologically benign solid nodules were randomly assigned to either a single RFA session ( group A ; n = @ ) or follow-up ( group B ; n = @ ) at our center .


Entry criteria were a solid thyroid nodule or predominantly solid ( with a fluid component @ % of the volume ) , normal thyroid function , no autoimmunity , and no previous thyroid gland treatment .


Three subgroups were formed according to the baseline volume of nodules : small ( @ mL ) , medium ( from @ to @ mL ) , or large ( > @ mL ) .


In group A RFA was performed in a single session with the moving-shot technique .


Volume and local symptom changes were evaluated @ and @ months after RFA .


In group A , the volume decreased from @ @ to @ @ @ months after RFA ( P = @ ) .


The greatest volume reduction was in small nodules .


The pressure symptom score improved only in medium and large nodules ( P < @ ) , whereas the cosmetic score improved in all treated patients ( P < @ ) .


The rate of thyroid volumetric reduction was not statistically different between solid and predominantly solid nodules .


Only one patient experienced permanent right paramedian vocal cord palsy with inspiratory stridor without dysphonia .


In group B , nodule volume remained unchanged , whereas the symptom score was worse at the @-month evaluation ( P = @ ) .


RFA is effective in reducing thyroid nodule volume .


The best reduction rate was observed in small TNs .


The thyroid volumetric reduction does not change according to the sonographic features .


The mean treatment duration was longer in larger TNs .


Prospective randomized controlled trial .


The aim of this study was to monitor the quality control of robot-assisted pedicle screw fixation accuracy by using a cumulative summation ( CUSUM ) test at the initial stage of its application .


Although robot-assisted pedicle screw fixation reduces screw misplacement rates and provides critical support for minimally invasive surgical procedures , there have been no reports relating to the monitoring of quality control of the accuracy of this robot-assisted pedicle screw fixation procedure .


Patients with lumbar spinal stenosis scheduled to undergo surgery were randomly and equally assigned through @:@ allocation to a robot-assisted minimally invasive posterior lumbar interbody fusion ( Rom-PLIF ) group or a conventional open posterior PLIF using freehand technique group .


The accuracy of pedicle screw placement was evaluated using postoperative computed tomography .


The primary outcome was the CUSUM analysis for monitoring the quality control of the accuracy of pedicle screw insertion between the Rom-PLIF and conventional open posterior PLIF using freehand technique groups .


Of the @ pedicle screws inserted in each group , @ screws in the Rom-PLIF group , and @ in the conventional open PLIF group , breached the pedicle .


Of these @ offending screws , @ cases were categorized as grade B in the Rom-PLIF group , whereas @ were grade B and @ case was grade C in the Com-PLIF group , using the Gertzbein and Robbins classification .


Throughout the monitoring period , there was no CUSUM test-derived indication that the quality of performance of the pedicle screw fixation procedure was inadequate in either group .


First , this study demonstrates the adequacy of quality control of robot-assisted pedicle screw fixation even early in the application period based on the CUSUM analysis .


Second , the CUSUM test can be a useful tool for monitoring of the quality of procedures related with spine surgery .


Gait retraining , comprising biofeedback and/or an exercise intervention , might reduce the risk of musculoskeletal conditions .


The purpose was to examine the effect of a gait-retraining program on medial tibial stress syndrome incidence during a @-wk basic military training regimen .


A total of @ British Army recruits volunteered .


On the basis of a baseline plantar pressure variable ( mean foot balance during the first @ % of stance ) , participants classified as at risk of developing medial tibial stress syndrome ( n = @ ) were randomly allocated to an intervention ( n = @ ) or control ( n = @ ) group .


The intervention involved supervised gait retraining , including exercises to increase neuromuscular control and flexibility ( three sessions per week ) and biofeedback enabling internalization of the foot balance variable ( one session per week ) .


Both groups continued with the usual military training regimen .


Diagnoses of medial tibial stress syndrome over the @-wk regimen were made by physicians blinded to the group assignment .


Data were modeled in a survival analysis using Cox regression , adjusting for baseline foot balance and time to peak heel rotation .


The intervention was associated with a substantially reduced instantaneous relative risk of medial tibial stress syndrome versus control , with an adjusted HR of @ ( @ % confidence interval , @-@ @ ) .


The number needed to treat to observe one additional injury-free recruit in intervention versus control at @ wk was @ ( @ to @ ) participants .


Baseline foot balance was a nonspecific predictor of injury , with an HR per @ SD increment of @ ( @ to @ ) .


The intervention was effective in reducing incidence of medial tibial stress syndrome in an at-risk military sample .


The aim of this study was to determine the efficacy of electrical stimulation when added to conventional physical therapy with regard to clinical and neurophysiologic changes in patients with Bell palsy .


This was a randomized controlled trial .


Sixty patients diagnosed with Bell palsy ( @ right sided , @ left sided ) were included in the study .


Patients were randomly divided into two therapy groups .


Group @ received physical therapy applying hot pack , facial expression exercises , and massage to the facial muscles , whereas group @ received electrical stimulation treatment in addition to the physical therapy , @ days per week for a period of @ wks .


Patients were evaluated clinically and electrophysiologically before treatment ( at the fourth week of the palsy ) and again @ mos later .


Outcome measures included the House-Brackmann scale and Facial Disability Index scores , as well as facial nerve latencies and amplitudes of compound muscle action potentials derived from the frontalis and orbicularis oris muscles .


Twenty-nine men ( @ % ) and @ women ( @ % ) with Bell palsy were included in the study .


In group @ , @ ( @ % ) patients had no axonal degeneration and @ ( @ % ) had axonal degeneration , compared with @ ( @ % ) and @ ( @ % ) patients in group @ , respectively .


The baseline House-Brackmann and Facial Disability Index scores were similar between the groups .


At @ mos after onset , the Facial Disability Index scores were improved similarly in both groups .


The classification of patients according to House-Brackmann scale revealed greater improvement in group @ than in group @ .


The mean motor nerve latencies and compound muscle action potential amplitudes of both facial muscles were statistically shorter in group @ , whereas only the mean motor latency of the frontalis muscle decreased in group @ .


The addition of @ wks of daily electrical stimulation shortly after facial palsy onset ( @ wks ) , improved functional facial movements and electrophysiologic outcome measures at the @-mo follow-up in patients with Bell palsy .


Further research focused on determining the most effective dosage and length of intervention with electrical stimulation is warranted .


To evaluate the efficacy and safety of tirofiban use immediately after successful percutaneous coronary intervention ( PCI ) in patients with moderate to high risk non-ST segment elevation acute coronary syndromes ( NSTE-ACS ) .


NSTE-ACS patients undergoing successful PCI ( n = @ ) were randomized by the envelope method to tirofiban group ( n = @ , @ g/kg bolus within @ min followed by @-@ @ gkg ( -@ ) min ( -@ ) for @ h i.v. ) or control group ( n = @ , saline i.v. for @ h ) .


The primary efficacy composite end point was death , myocardial infarction , target vascular revascularization or ischemic stroke at @ days .


The second end point was the occurrence of composite end point at @ days or @ months .


Key safety end points were bleeding and thrombocytopenia @ days after PCI .


Baseline characteristics were well-balanced between the two groups ( P > @ ) .


The primary end point occurred in @ % ( @/@ ) patients in the tirofiban group and @ % ( @/@ ) patients of those in the control group ( P = @ ) .


There was no significant difference in the composite end point at @ days -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) , P = @ -RSB- between the groups , however , there was a trend towards lower composite efficacy end points at @ months in tirofiban group compared to control group -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) , P = @ -RSB- .


The probability of survival free of composite end point was significantly higher in the tirofiban group than that in the control group ( @ % vs. @ % , log-rank test , P = @ ) .


There was no GUSTO severe or moderate bleeding or severe thrombocytopenia within @ days post-PCI .


There was no significant difference in mild bleeding -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) , P = @ -RSB- or mild thrombocytopenia -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) , P = @ -RSB- between the groups .


Tirofiban use after successful PCI can improve @-month event-free survival without increasing the risk of bleeding for patients with moderate to high risk NSTE-ACS .


There are no data regarding the effect of weight loss on clinical outcomes in patients undergoing cardiac resynchronization therapy .


This study was designed to evaluate the effect of weight loss on clinical outcomes in patients implanted with a cardiac resynchronization therapy with defibrillator ( CRT-D ) .


The risk of heart failure ( HF ) or death , and of death alone , was compared between patients with and without weight loss of @ kg or more at @ year in the CRT-D arm of the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy ( MADIT-CRT ) .


Weight loss was observed in @ of @ patients ( @ % ) implanted with a CRT-D .


Multivariate analysis showed a significant increase in the risk of HF or death among patients with weight loss compared with those without weight loss ( hazard ratio -LSB- HR -RSB- @ , @ % confidence interval -LSB- CI -RSB- @-@ @ ; P = @ ) .


Weight loss was associated with a @ % increase in the risk of all-cause mortality ( HR @ , @ % CI @-@ @ ; P = @ ) .


When analyzed in a continuous fashion , each kg of weight loss was associated with a @ % increase in the risk of HF or death ( P = @ ) .


In left bundle branch block ( LBBB ) patients with a CRT-D , weight loss was associated with an especially high risk of HF or death ( HR @ , @ % CI @-@ @ ; P = @ ) and of death alone ( HR @ , @ % CI @-@ @ ; P = @ ; interaction P = @ ) .


In patients with mild symptoms of HF receiving CRT-D , weight loss observed at @ year is associated with adverse clinical outcomes , especially in those with a LBBB electrocardiographic pattern .


Progesterone has been associated with robust positive effects in animal models of traumatic brain injury ( TBI ) and with clinical benefits in two phase @ randomized , controlled trials .


We investigated the efficacy and safety of progesterone in a large , prospective , phase @ randomized clinical trial .


We conducted a multinational placebo-controlled trial , in which @ patients , @ to @ years of age , with severe TBI ( Glasgow Coma Scale score , @ -LSB- on a scale of @ to @ , with lower scores indicating a reduced level of consciousness -RSB- and at least one reactive pupil ) were randomly assigned to receive progesterone or placebo .


Dosing began within @ hours after injury and continued for @ hours .


The primary efficacy end point was the Glasgow Outcome Scale score at @ months after the injury .


Proportional-odds analysis with covariate adjustment showed no treatment effect of progesterone as compared with placebo ( odds ratio , @ ; confidence interval , @ to @ ) .


The proportion of patients with a favorable outcome on the Glasgow Outcome Scale ( good recovery or moderate disability ) was @ % with progesterone , as compared with @ % with placebo .


Mortality was similar in the two groups .


No relevant safety differences were noted between progesterone and placebo .


Primary and secondary efficacy analyses showed no clinical benefit of progesterone in patients with severe TBI .


These data stand in contrast to the robust preclinical data and results of early single-center trials that provided the impetus to initiate phase @ trials .


( Funded by BHR Pharma ; SYNAPSE ClinicalTrials.gov number , NCT@ . )


To observe the effect of Kuntai Capsule ( KC ) , a Chinese patent medicine , in add-back therapy for gonadotropin-releasing hormone agonist ( GnRH-a ) treatment for moderate-severe endometriosis ( EM ) .


Totally @ patients suffering from stage III/IV EM , who were confirmed by laparoscopic surgery were randomly assigned to the GnRH-a group ( A ) and the KC combined GnRH-a group ( B ) , @ in each group .


Patients in Group A were hypodermically injected with goserelin ( @ mg ) , once per @ weeks .


Those in Group B additionally took KC , @ pills each time , three times per day .


The therapeutic course for all was @ weeks .


Serum levels of estradiol ( E@ ) , follicle stimulating hormone ( FSH ) , bone gamma-carboxyglutamic-acid-containing proteins ( BGP ) were measured respectively .


Kupperman Menopausal Index ( KMI ) and bone mineral density ( BMD ) of the lumbar vertebra were also compared between the two groups .


Serum levels of E@ and FSH both significantly decreased in the two groups at week @ of the treatment ( P < @ ) , when compared with pre-treatment .


Compared with before treatment in the same group , KMI increased in the two groups ( P < @ ) .


Compared with before treatment in the same group , BMI decreased in the two groups with no statistical difference ( P > @ ) .


Serum BGP increased after @-week treatment ( P < @ ) .


Compared with Group A after treatment , serum levels of E@ and FSH both significantly increased in Group B ( P < @ ) .


There was no statistical difference in KMI between the two groups ( P > @ ) .


As for the incidence of menopausal symptoms , better effects in improving symptoms such as hot flashes , sleep disorders , and vaginal dryness were obtained in Group B than in Group A ( P < @ ) .


There was no significant difference in the post-pre-treatment difference of BMI between the two groups , but with statistical post-pre-treatment difference in the BGP level ( P < @ ) .


HKC combined GnRH-a could effectively reduce GnRH-a treatment induced partial low estrogen symptoms , improve increased serum BGP levels after GnRH-a therapy .


To compare the frequency of achieving a therapeutic serum digoxin concentration ( SDC ) , defined as @-@ @ ng/ml , by using a simplified nomogram to individualize digoxin dosing with standard dosing practices in patients with heart failure , and to characterize the relationship between genetic polymorphisms of the ABCB@ gene and SDC .


Prospective study with a historical control group .


Outpatient care center of an urban academic medical center .


A total of @ adults with heart failure due to left ventricular dysfunction who were treated with digoxin .


Digoxin doses were determined either by the dosing nomogram ( @ patients ) or standard care ( SC ; @ patients ) by using historical controls who were randomly selected from a list of SDCs obtained from laboratory records and who had their digoxin doses determined by standard dosing practices .


The primary end point was the proportion of patients achieving a steady-state SDC of @-@ @ ng/ml ; secondary end points were mean SDC and proportion of patients achieving a steady-state SDC lower than @ ng/ml .


Postdistributive steady-state SDCs were measured @-@ weeks after digoxin dosage adjustment or initiation .


Therapeutic SDCs were achieved with similar frequency in both groups ( @ % in the nomogram group vs @ % in the SC group , p = @ ) ; however , more patients in the nomogram group had SDCs lower than @ ng/ml than in the SC group ( @ % vs @ % , p < @ ) .


Mean daily digoxin doses were lower in the nomogram group ( @ @ g vs @ @ g , p = @ ) , resulting in lower mean SDCs compared with those in the SC group ( @ @ ng/ml vs @ @ ng/ml , p < @ ) .


Patients in the pharmacogenetic substudy provided blood samples for genotyping of three common ABCB@ single nucleotide polymorphisms : C@T ( rs@ ) , G@T/A ( rs@ ) , and C@T ( rs@ ) .


SDCs were not significantly associated with ABCB@ genotypes .


Our simplified digoxin dosing nomogram resulted in lower SDCs compared with standard dosing practices but achieved therapeutic SDCs with similar frequency .


A greater proportion of patients dosed according to our nomogram had SDCs lower than @ ng/ml , consistent with consensus guidelines .


Genetic polymorphisms of the ABCB@ gene were not associated with SDC .


Randomized controlled trial .


Objective To determine if force magnitude during posterior-to-anterior mobilization affects immediate and short-term outcomes in patients with chronic , nonspecific neck pain .


The optimal dose of mobilization to effectively treat patients with neck pain is not known .


Patients with neck pain of at least @ months in duration ( n = @ ) were randomized to receive a single treatment of posterior-to-anterior mobilization applied with @ N or @ N of mean peak force ( @ sets of @ seconds ) or a placebo ( detuned laser ) on the spinous process at the painful spinal level .


Pressure pain threshold , pain measured with a visual analog scale ( range , @-@ mm ) , cervical range of motion , and spinal stiffness at the painful spinal level ( measured with a custom device and normalized as a percentage of C@ stiffness ) were assessed before , immediately after , and at a mean SD follow-up of @ @ days following treatment .


Repeated-measures analysis of covariance and Bonferroni-adjusted post hoc tests determined group differences for each outcome measure after treatment and at follow-up .


At follow-up , the @-N group had less pain than the @-N group ( mean difference , @ mm ; @ % confidence interval : @ , @ mm ; P = @ ) and lower stiffness than the placebo group ( mean difference , @ % ; @ % confidence interval : @ % , @ % ; P = @ ) .


These differences were not present immediately after treatment .


There were no significant between-group differences in pressure pain threshold or range of motion after treatment or at follow-up .


A specific dose of mobilization , in terms of applied force , appears necessary for reducing stiffness and potentially pain in patients with chronic neck pain .


Changes were not observed immediately after mobilization , suggesting that its effects are not directly mechanical .


Australian and New Zealand Clinical Trials Registry ( http://www.anzctr.org.au/ ) : ACTRN@ .


Therapy , level @b - .


To measure the value of augmented reality technology usage to teach the medical students performing binocular indirect ophthalmoscopy .


Thirty-seven medical students were randomly assigned to the training of binocular indirect ophthalmoscopy either in the conventional way or with augmented reality ophthalmoscopy ( ARO ) .


For testing student 's skills , they had to examine a real person using a conventional ophthalmoscopy system and draw the optic disk .


They also had to fill out a questionnaire .


Subjective and objective evaluations were performed .


Thirty-seven students were randomly assigned to two groups .


Eighteen students were trained with conventional ophthalmoscopy and @ students with ARO .


The questionnaires showed no differences .


Performing an objective analysis , the median ophthalmoscopy training score for the conventional ophthalmoscopy group was @ ( range , @-@ ) and showed a significant difference ( P < @ ) to the ARO group ( median @ ; range , @-@ ) .


The study provides evidence that a single ARO training is efficient to improve ophthalmoscopy skills .


As the objective analysis showed , the ARO group had a significantly superior performance .


Our study also indicates that subjective evaluation of the fundus drawings without systematic analysis is prone to errors .


Neck circumference ( NC ) has been previously related to cardiometabolic risk factors .


In this study we examined the association between NC and early stage atherosclerosis in Chinese adults .


The study samples were from a community-based health examination survey in central China .


In total @,@ men and women ( @-@ y ) were included in the final analyses .


Carotid radial pulse wave velocity ( crPWV ) , carotid femoral PWV ( cfPWV ) , carotid artery dorsalis pedis PWV ( cdPWV ) and NC were measured .


After adjustment for age , sex , lipids , glucose , blood pressure , heart rate , body mass index ( BMI ) , high NC was significantly associated with an increasing trend of cfPWV , cdPWV and crPWV ( P = @ , @ , and @ ; respectively ) .


In addition , we found significant interaction between hypertension status and NC level in relation to cfPWV , adjusted for age , sex , BMI , fasting glucose , lipids and heart rate ( P for interaction = @ ) .


The associations between NC and cfPWV were significant ( P = @ ) among those with hypertension , but not significant among those without hypertension .


Our data showed that high NC was associated with an increased risk of early stage atherosclerosis in Chinese adults , independent of other metabolic risk factors .


Hypertension might modify the association between NC and cfPWV .


Platinum-based chemotherapy is the cornerstone of treatment of advanced non-small-cell lung cancer ( NSCLC ) patients , but the efficacy of adding cisplatin to single-agent chemotherapy remains to be demonstrated in prospective phase III trials dedicated to elderly patients .


Furthermore , the superiority of cisplatin/pemetrexed over cisplatin/gemcitabine in non-squamous NSCLC has not been confirmed prospectively .


We present the rationale and design of two open-label , multicenter , randomized phase III trials for elderly patients with advanced NSCLC Multicenter Italian Lung cancer in the Elderly Study ( MILES ) -@ and MILES-@ .


The aim is to evaluate the efficacy of adding cisplatin to single-agent chemotherapy ( both trials ) and the efficacy of pemetrexed versus gemcitabine in non-squamous tumors ( MILES-@ ) .


Both trials are dedicated to first-line therapy of patients older than @ years with advanced NSCLC , ECOG performance status @-@ .


In the MILES-@ trial , patients are randomized in a @ ratio to gemcitabine or cisplatin/gemcitabine .


In the MILES-@ study patients with non-squamous histology are randomized , in a factorial design with @ ratio , to four arms : gemcitabine ( A ) , cisplatin/gemcitabine ( B ) , pemetrexed ( C ) , cisplatin/pemetrexed ( D ) .


Two comparisons are planned A+C vs B+D to test the role of cisplatin ; A+B vs C+D to test the role of pemetrexed .


Primary endpoint of both trials is overall survival .


Secondary and exploratory endpoints include progression-free survival , response rate , toxicity , and quality of life .


MILES-@ and MILES-@ results will add important evidence about the role of cisplatin-based doublets and pemetrexed in the first-line therapy of elderly patients with advanced NSCLC .


Birth and immediate postpartum period pose many challenges for the newborn .


The neonatal mortality rates are high in India , whereas the breastfeeding rates are still low .


Hence , need exists for a simple and easily applicable intervention , which may counter these challenges .


The present study was undertaken to evaluate the effects of very early skin-to-skin contact ( SSC ) , in term babies with their mothers , on success of breastfeeding and neonatal well-being .


Randomized control trial conducted over @ years ' period in a tertiary care hospital .


Healthy babies delivered normally were included .


Very early SSC between mothers and their newborns was initiated in the study group .


We studied effective suckling ( using modified infant breastfeeding assessment tool -LSB- IBFAT -RSB- ) , breastfeeding status at @ weeks , maternal satisfaction , thermal regulation , baby 's weight and morbidity .


T-test , Pearson Chi-square test and non-parametric Mann-Whitney test were used through relevant Windows SPSS software version @ .


We observed that SSC contributed to better suckling competence as measured by IBFAT score ( P < @ ) .


More babies in the SSC group were exclusively breastfed at first follow-up visit ( P = @ ) and at @ weeks ( P < @ ) .


SSC led to higher maternal satisfaction rates , better temperature gain in immediate post-partum period , lesser weight loss was at discharge and at first follow-up ( all P < @ ) and lesser morbidity than the study group ( P = @ ) .


Very early SSC is an effective intervention that improves baby 's suckling competence , maternal satisfaction , breastfeeding rates and temperature control and weight patterns .


Hypnotic drugs tend to be the dominant form of treatment of insomnia , but these come with a number of reported side effects .


Acupuncture has been studied as an alternative , resulting in a rising need for methodological research towards verifying its efficacy as insomnia treatment .


We describe a proposal for a single-center , patient-assessor-blinded , randomized controlled trial with two parallel arms .


A total of @ patients complete screening tests at the first visit , are registered into the clinical trial , and then randomly assigned to the experimental or sham control groups ( @ patients for each group ) .


All subjects are clinical insomnia patients who score a @ or above on the Pittsburgh Sleep Quality Index ( PSQI ) and meet all inclusion criteria .


All subjects are treated with acupuncture and intradermal acupuncture ( IDA ) three times during the first week .


Five sham acupoints are used in the control group .


In the experimental group , five real acupoints ( PC@ , SP@ , HT@ , KI@ , and BL@ ) are used unilaterally in turn .


Sham acupoints are over @ cm away from each real acupoint.The primary outcomes are the scores on the Insomnia Severity Index ( ISI ) and PSQI .


Secondary outcomes are the sleep log , the Beck Depression Inventory ( BDI ) , the State-Trait Anxiety Inventory ( STAI ) , the World Health Organization Quality of Life Abbreviated Version ( WHOQOL-BREF ) , the Korean-Auditory Verbal Learning Test ( K-AVLT ) , the Digit Span Test ( DS ) , Event Related Potentials ( ERPs ) and heart rate variability ( HRV ) to assess emotional states , sleep quality , cognitive functioning , and electro-physiological changes.Subjects are assessed at three time points : baseline , post-treatment and follow-up .


The duration of the clinical trial is @ days .


To study the enhancement of the effectiveness of acupuncture for insomnia , we test the intradermal acupuncture method , which is performed continuously on the subject 's skin and stimulated at home by the subject every night .


In the trial , objective measurements including ERPs and HRV are used to evaluate states of cognition and autonomic nervous system functioning and subjective self-report questionnaires assess insomnia symptoms .


` Sham ' acupuncture points provided by STRICTA are used for the control group .


To examine the effects of exercise intensity on acute changes in endothelial function in lean and obese adults .


Sixteen lean ( BMI < @ , age @ @ yr ) and @ obese ( BMI > @ , age @ @ yr ) physically inactive adults were studied during @ randomized admissions -LSB- control ( C , no exercise ) , moderate-intensity exercise ( M , @ lactate threshold ( LT ) ) and high-intensity exercise ( H , midway between LT and VO@peak ) ( @ min ) -RSB- .


Endothelial function was assessed by flow-mediated dilation ( FMD ) at baseline and @ , @ , and @ h post-exercise .


RM ANCOVA revealed significant main effects for group , time , and group x condition interaction ( p < @ ) .


A diurnal increase in FMD was observed in lean but not obese subjects .


Lean subjects exhibited greater increases in FMD than obese subjects ( p = @ ) .


In the obese group a trend was observed for increases in FMD at @ - and @-hr after M ( p = @ ) .


For lean subjects , FMD was significantly elevated at all time points after H.


The increase in FMD after H in lean subjects ( @ @ % ) was greater than after both C ( @ @ % , p = @ ) and M ( @ @ % , p = @ ) .


FMD responses of lean and obese subjects significantly differed after C and H , but not after M.


In lean young adults , high-intensity exercise acutely enhances endothelial function , while moderate-intensity exercise has no significant effect above that seen in the absence of exercise .


The FMD response of obese adults is blunted compared to lean adults .


Diurnal variation should be considered when examining the effects of acute exercise on FMD .


Novel therapies are needed for difficult-to-treat populations of patients with psoriasis .


We sought to assess the efficacy and safety of the interleukin-@ Receptor A inhibitor brodalumab in patients with psoriasis with or without a self-reported history of psoriatic arthritis ( PsA ) and with or without a history of biologic use .


Subset analyses of a phase II , randomized , double-blind , placebo-controlled study of brodalumab in patients with moderate-to-severe plaque psoriasis were performed .


Improvement from baseline in Psoriasis Area and Severity Index score of @ % , @ % , and @ % at week @ ; static Physician Global Assessment ( @/@ ) score ; Dermatology Life Quality Index response ; and Psoriasis Symptom Inventory response were evaluated within subgroups .


Efficacy and quality-of-life measures were generally similar between subgroups of patients with or without a history of PsA and with or without a history of biologic use across brodalumab doses and were significantly higher among patients who received brodalumab @ mg every @ weeks or @ mg every @ weeks versus placebo .


Differences between subgroups were not compared statistically , PsA was self-reported , only skin involvement/symptoms were reported , and reasons for discontinuation of prior biologic were not captured .


Brodalumab is efficacious in patients with psoriasis with or without a history of PsA or biologic use .


The effect of exercise training during the course of pregnancy on the newborn 's birth weight is unclear .


This study examines the effect of aerobic and strength conditioning exercise performed during the second and the third trimester of pregnancy in nulliparous , previously inactive women on the newborn 's outcome .


Sixty-three nulliparous , previously sedentary , were randomly assigned to either an exercise ( N. = @ ) or a control ( N. = @ ) group .


The subjects participated in the exercise group ( EG ) focused on aerobic and strength-conditioning exercise in three sessions for about @ weeks .


We registered the birth weight , birth length , gestational age at time of delivery , Apgar score and head circumference of the newborn .


There were no statistically significant differences between the two groups in mean birth weight , length , head circumference , and length of gestation .


There was a significant difference between two groups in Apgar scores at @ min ( P = @ ) and @ min ( P = @ ) with newborns of the EG scoring higher than the CG .


Supervised , aerobic and strength conditioning exercise performed over the second and third trimester of pregnancy does not have a negative impact on the newborn 's body size and health .


Stenting has been used as a rescue therapy in patients with intracranial arterial stenosis and a transient ischemic attack or stroke when on antithrombotic therapy ( AT ) .


We determined whether the stenting versus aggressive medical therapy for intracranial arterial stenosis ( SAMMPRIS ) trial supported this approach by comparing the treatments within subgroups of patients whose qualifying event ( QE ) occurred on versus off of AT .


The primary outcome , @-day stroke and death and later strokes in the territory of the qualifying artery , was compared between ( @ ) percutaneous transluminal angioplasty and stenting plus aggressive medical therapy ( PTAS ) versus aggressive medical management therapy alone ( AMM ) for patients whose QE occurred on versus off AT and between ( @ ) patients whose QE occurred on versus off AT separately for the treatment groups .


Among the @/@ ( @ % ) patients who had their QE on AT , the @-year primary end point rates were @ % for those randomized to AMM ( n = @ ) and @ % for PTAS ( n = @ ; P = @ , log-rank test ) .


In the @ patients not on AT , the @-year primary end point rates were @ % for AMM ( n = @ ) and @ % for PTAS ( n = @ ; P = @ , log-rank test ) .


Within both treatment groups , there was no difference in the time to the primary end point between patients who were on or off AT ( AMM , P = @ ; PTAS , P = @ ; log-rank test ) .


SAMMPRIS results indicate that the benefit of AMM over PTAS is similar in patients on versus off AT at the QE and that failure of AT is not a predictor of increased risk of a primary end point .


Research has demonstrated that after exposure treatment , re-exposure to a previously feared stimulus outside of the treatment context can result in renewal of fear .


The current study investigated whether conducting exposure treatment in multiple real-life contexts can attenuate renewal of fear .


Forty-six moderate to high spider fearful individuals were randomly allocated to groups that received exposure treatment in either one context or three contexts .


Follow-up testing was conducted one week and four weeks after exposure in the treatment context or a novel context .


Renewal of fear was found for the single extinction context group when exposed to the feared object in a novel context with self-report of fear , heart rate , and behavioural avoidance .


However , renewal of fear was attenuated for the multiple extinction context group .


The sample included moderate to high spider fearful participants rather than clients with spider phobia , potentially limiting the generalisability of the findings to clinical populations .


Using multiple extinction contexts in combination with other methods of attenuating renewal ( e.g. , context similarity ) may provide a means to reduce the risk of renewal of fear .


To explore the effects of different antihypertensive strategies on blood pressure and urinary albumin excretion in patients with hypertension and microalbuminuria .


For this multi-center , randomized , positively controlled clinical trial , a total of @ patients with mild-to-moderate essential hypertension and microalbuminuria were enrolled .


They were divided randomly into calcium channel blocker ( CCB ) , angiotensin II receptor antagonist ( ARB ) and CCB+ARB groups .


The whole treatment period was @ months .


According to ANOVA analysis , the post-therapeutic urinary albumin level decreased @ , @ and @ mg/L in CCB , ARB and CCB+ARB groups respectively ( P = @ ) .


And the extents of urinary albumin reduction were @ and @ mg/L in patients with controlled and uncontrolled blood pressure respectively ( P < @ ) .


Effective antihypertensive therapy is a key for decreasing urinary albumin excretion in hypertensive patients .


As compared with calcium antagonists , ARB-containing regimens appear to be better in reducing urinary albumin .


The study was designed to investigate the success rate and time of insertion intraosseous access during simulated resuscitation .


This was a randomized crossover study involving @ paramedics .


They were timed from start of insertion attempt to successful insertion and asked to score perceived difficulty of intraosseus access devices .


Bone injection gun ( BIG ) ( WaisMed Company , Houston , TX ) , EZ-IO ( Vidacare , Shavano Park , TX ) and Jamshidi ( Carefusion , San Diego , CA ) were used in this study .


Success rates for first intraosseus iniecition attempt were higher for the BIG ( @ % ) than EX-IO ( @ % ) or Jamshidi ( @ % ) .


Mean procedure time was @ vs @ minutes for EZ-IO vs @ minutes for Jamshidi .


The use of BIG is associated with excellent success rates for insertion and appears easier to use than EZ-IO or Jamshidi Intraosseus Needle .


Further work to evaluate the use of the intraosseus access device in the emergency medical services is required .


Chronic hepatitis C infection is the leading cause of hepatocellular carcinoma ( HCC ) , a highly lethal malignancy with rapidly increasing prevalence in the United States .


Little is known about genetic variations and HCC risk .


This study aimed to determine if genetic variation in Wnt signaling pathway genes are associated with advanced hepatic fibrosis and inflammation risk in a hepatitis C virus ( HCV ) infected population .


We performed a genetic association cross-sectional study evaluating single nucleotide polymorphisms ( SNPs ) in @ candidate genes and risk of FibroSURE-Acti Test determined advanced fibrosis ( F@/F@-F @ advanced cases vs. F@-F@ mild controls ) and inflammation ( A@/A@-A @ advanced cases vs. A@-A@ mild controls ) .


We calculated odds ratios ( ORs ) and @ % confidence intervals ( CIs ) employing multivariate logistic regression .


Haplotypes were inferred by the HAPLO.STAT program , interactions were evaluated using multifactor dimensionality reduction ( MDR ) analysis .


Among @ chronically HCV-infected male veterans , @ ( @ % ) had advanced fibrosis and @ ( @ % ) had advanced inflammation .


Of @ SNPs evaluated , eight were significantly associated with fibrosis risk ( e.g. , SFRP@ rs@ : OR = @ , @ % CI @-@ @ , P = @ ) , and seven were significantly associated with inflammation risk ( e.g. , SFRP@ rs@ : OR = @ , @ % CI @-@ @ , P = @ ) .


MDR analysis identified overweight/obese , SOST rs@ , SFRP@ rs@ , and FZD@ rs@ as the best interaction model for predicting risk of fibrosis ; whereas race/ethnicity , FZD@ rs@ , and TBX@ rs@ as the best interaction model for predicting risk of inflammation .


Polymorphisms in several genes involved in the Wnt signaling pathway were associated with hepatic fibrosis or inflammation risk in HCV-infected males .


Additional studies in other multi-ethnic HCV cohorts are needed to validate our findings in males and to assess if similar associations exist in chronically HCV-infected females .


During the @ influenza pandemic both seasonal and @ pandemic vaccines were recommended .


We conducted a randomized trial of monovalent @-H@N@ vaccine and seasonal trivalent inactivated influenza vaccine ( IIV@ ) given sequentially or concurrently to adults .


Adults randomized to @ study groups and stratified by age ( @-@ and @ years ) received @ dose of seasonal IIV@ or placebo and @ doses of @-H@N@ vaccine or placebo in one of @ combinations , i.e. , H@N@ + Placebo/H@N@ + Placebo/IIV@ ( HP/HP/V@ ) , H@N@ + IIV@/H@N@ + Placebo/Placebo ( HV@/HP/P ) , H@N@ + Placebo/H@N@ + IIV@/Placebo ( HP/HV@/P ) , and IIV@ + Placebo/H@N@ + Placebo/H@N@ ( V@P/HP/H ) .


Intramuscular injections were given three times at @ day intervals .


Sera for antibody assays were obtained prior to and @ days after each vaccination .


Reactogenicity and adverse events were monitored .