We did this randomised phase 3 trial with a two-by-two factorial design at 230 hospitals in Japan .


We enrolled patients aged 20-80 years with T4a or T4b gastric cancer , who had had D2 dissection and a ECOG performance score of 0-1 .


Patients were randomly assigned to one of four treatment groups with minimisation for tumour size , lymph node metastasis , and study site .


Patients received UFT only ( 267 mg/m ( 2 ) per day ) , S-1 only ( 80 mg/m ( 2 ) per day ) for 14 days , with a 7-day rest period or three courses of intermittent weekly paclitaxel ( 80 mg/m ( 2 ) ) followed by either UFT , or S-1 .


Treatment lasted 48 weeks in monotherapy groups and 49 weeks in the sequential treatment groups .


The primary endpoint was disease-free survival assessed by intention to treat .


We assessed whether UFT was non-inferior to S-1 with a non-inferiority margin of 133 .


This trial was registered at UMIN Clinical Trials Registry , number C000000082 .


We randomly assigned 1495 patients between Aug 3 , 2004 , and Sept 29 , 2009.374 patients were assigned to receive UFT alone , 374 to receive S-1 alone , 374 to received paclitaxel then UFT , and 373 to receive paclitaxel then S-1 .


We included 1433 patients in the primary analysis after at least 3 years of follow-up ( 359 , 364 , 355 , and 355 in each group respectively ) .


Protocol treatment was completed by 215 ( 60 % ) patients in the UFT group , 224 ( 62 % ) in the S-1 group , 242 ( 68 % ) in the paclitaxel then UFT group , and 250 ( 70 % ) in the paclitaxel then S-1 group .


3-year disease-free survival for monotherapy was 540 % ( 95 % CI 502-576 ) and that of sequential treatment was 572 % ( 534-608 ; hazard ratio [ HR ] 092 , 95 % CI 080-107 , p = 0273 ) .


3-year disease-free survival for the UFT group was 530 % ( 95 % CI 492-566 ) and that of the S-1 group was 582 % ( 544-618 ; HR 081 , 95 % CI 070-093 , p = 00048 ; pnon-inferiority = 0151 ) .


The most common grade 3-4 haematological adverse event was neutropenia ( 41 [ 11 % ] of 359 patients in the UFT group , 48 [ 13 % ] of 363 in the S-1 group , 46 [ 13 % ] of 355 in the paclitaxel then UFT group , and 83 [ 23 % ] of 356 in the paclitaxel then S-1 group ) .


The most common grade 3-4 non-haematological adverse event was anorexia ( 21 [ 6 % ] , 24 [ 7 % ] , seven [ 2 % ] , and 18 [ 5 % ] , respectively ) .


Sequential treatment did not improve disease-free survival , and UFT was not non-inferior to S-1 ( and S-1 was superior to UFT ) , therefore S-1 monotherapy should remain the standard treatment for locally advanced gastric cancer in Japan .


Epidemiological and Clinical Research Information Network .


To explore the effect of high positive end-expiratory pressure ( PEEP ) for the treatment of neurological pulmonary edema ( NPE ) in patients undergoing mechanical ventilation , and to look for the best mechanical ventilation strategy to improve the prognosis .


A prospective study was conducted , and 120 patients with NEP admitted to Department of Critical Care Medicine of the First Affiliated Hospital of Guangxi Traditional Chinese Medical University from January 2010 to August 2013 were enrolled and divided into two groups according to random number table ( n = 60 in each group ) .


The patients in two groups were given empiric treatment for the disease , and they underwent mechanical ventilation .


In the normal PEEP group PEEP was 3-10 cmH2O ( 1 cmH2O = 0.098 kPa ) , and in the high PEEP group PEEP was 11-30 cmH2O , and all the rest parameters were the same .


Clinical indices before and 7 days after treatment , and 28-day morality rate were compared between two groups .


The 28-day morality rate in high PEEP group was obviously lower than that in the normal PEEP group [ 25.0 % ( 15/60 ) vs. 65.0 % ( 39/60 ) , ( 2 ) = 6.465 , P = 0.011 ] .


The clinical signs in both groups were improved after treatment .


Compared with the normal PEEP group , the clinical indices in high PEEP group were more significantly improved .


There were significant differences in body temperature ( 37.40.5 centigrade vs. 38.50.6 centigrade ) , respiratory rate ( 18.33.1 times/min vs. 23.33.5 times/min ) , heart rate ( 94.78.5 beats/min vs. 113.58.0 beats/min ) , white blood cell count ( WBC : 12.52.1 10 ( 9 ) / L vs. 17.11.7 10 ( 9 ) / L ) , acute physiology and chronic health evaluation II ( APACHEII ) score ( 15.63.2 vs. 19.83.7 ) , Glasgow coma score ( GCS : 12.52.1 vs. 8.52.9 ) , gastrointestinal dysfunction score ( 3.93.0 vs. 3.62.4 ) , oxygenation index ( PaO2/FiO2 : 196.545.1 mmHg vs. 134.122.3 mmHg ) , serum creatinine ( SCr : 86.535.6 mol/L vs. 98.537.7 mol/L ) , total bilirubin ( TBil : 39.723.5 mol/L vs. 41.516.2 mol/L ) , C-reacting protein ( CRP : 53.721.4 mmol/L vs. 108.426.3 mmol/L ) , prothrombin time ( PT : 15.02.1 s vs. 20.42.2 s ) , activated partial thromboplastin time ( APTT : 37.34.9 s vs. 56.713.6 s ) , international normalized ratio ( INR : 2.520.64 vs. 4.010.77 ) , extra vascular lung water index ( EVLWI : 7.531.21 mL/kg vs. 15.853.41 mL/kg ) , pulmonary vascular permeability index ( PVPI : 6.070.89 vs. 9.471.26 ) , mean arterial pressure ( MAP : 87.310.9 mmHg vs. 98.713.6 mmHg ) , cardiac output ( CO : 7.151.42 L/min vs. 5.651.82 L/min ) , systemic vascular resistance index ( SVRI : 112.49.5 KP vs. 136.511.9 KP ) , and blood lactate ( 2.531.23 mmol/L vs. 5.812.17 mmol/L ) between high PEEP group and normal PEEP group ( P < 0.05 or P < 0.01 ) .


Prognosis can be improved in NPE patients with the use of high PEEP in mechanical ventilation .


To assess the contribution of contrast material in detecting and evaluating enthesitis of pelvic entheses by MRI .


Sixty-seven hip or pelvic 1.5-T MRIs ( 30:37 male : female , mean age : 53 years ) were retrospectively evaluated for the presence of hamstring and gluteus medius ( GM ) enthesitis by two readers ( a resident and an experienced radiologist ) .


Short tau inversion recovery ( STIR ) and T1-weighted pre - and post-contrast ( T1 + Gd ) images were evaluated by each reader at two sessions .


A consensus reading of two senior radiologists was regarded as the gold standard .


Clinical data was retrieved from patients ' referral form and medical files .


Cohen 's kappa was used for intra - and inter-observer agreement calculation .


Diagnostic properties were calculated against the gold standard reading .


A total of 228 entheses were evaluated .


Gold standard analysis diagnosed 83 ( 36 % ) enthesitis lesions .


Intra-reader reliability for the experienced reader was significantly ( p = 0.0001 ) higher in the T1 + Gd images compared to the STIR images ( hamstring : k = 0.84 / 0.45 , GM : k = 0.84 / 0.47 ) .


Sensitivity and specificity increased from 0.74 / 0.8 to 0.87 / 0.9 in the STIR images and T1 + Gd sequences .


Intra-reader reliability for the inexperienced reader was lower ( p > 0.05 ) .


Evidence showing that contrast material improves the reliability , sensitivity , and specificity of detecting enthesitis supports its use in this setting .


Irritable bowel syndrome ( IBS ) is a chronic , disabling condition that greatly compromises patient functioning .


The aim of this study was to assess the impact of a 6-week twice per week Iyengar yoga ( IY ) program on IBS symptoms in adolescents and young adults ( YA ) with IBS compared with a usual-care waitlist control group .


Assessments of symptoms , global improvement , pain , health-related quality of life , psychological distress , functional disability , fatigue , and sleep were collected pre - and posttreatment .


Weekly ratings of pain , IBS symptoms , and global improvement were also recorded until 2-month follow-up .


A total of 51 participants completed the intervention ( yoga = 29 ; usual-care waitlist = 22 ) .


Baseline attrition was 24 % .


On average , the yoga group attended 75 % of classes .


Analyses were divided by age group .


Relative to controls , adolescents ( 14-17 years ) assigned to yoga reported significantly improved physical functioning , whereas YA ( 18-26 years ) assigned to yoga reported significantly improved IBS symptoms , global improvement , disability , psychological distress , sleep quality , and fatigue .


Although abdominal pain intensity was statistically unchanged , 44 % of adolescents and 46 % of YA reported a minimally clinically significant reduction in pain following yoga , and one-third of YA reported clinically significant levels of global symptom improvement .


Analysis of the uncontrolled effects and maintenance of treatment effects for adolescents revealed global improvement immediately post-yoga that was not maintained at follow-up .


For YA , global improvement , worst pain , constipation , and nausea were significantly improved postyoga , but only global improvement , worst pain , and nausea maintained at the 2-month follow-up .


The findings suggest that a brief IY intervention is a feasible and safe adjunctive treatment for young people with IBS , leading to benefits in a number of IBS-specific and general functioning domains for YA .


The age-specific results suggest that yoga interventions may be most fruitful when developmentally tailored .


The objective of this study was to characterize the pharmacokinetics of 25 , 100 , and 150mg equivalents ( eq . )


of paliperidone long-acting injection in Chinese subjects with schizophrenia .


This was an open-label , randomized , parallel group , multicenter study .


A total of 48 patients were randomized in a 1:1:1 ratio to one of three groups .


Sequential blood samples were collected immediately before injection on day1 and up to 210days after the first injection .


The plasma paliperidone concentrations were determined by a validated high-performance liquid chromatography/tandem mass spectrometry method .


A total of 47 patients received at least one injection of the study medication , and 43 completed the study .


The pharmacokinetic ( PK ) parameters , such as time to maximum concentration , t1/2 , and CL/F , were comparable across the three treatment groups ( p = 0.935 , 0.349 , and 0.794 , respectively ) .


The differences in maximum plasma concentration , AUC ( 035days ) , AUC ( 0-210 days ) , and AUC ( 0 - ) were significant ( p < 0.001 ) and dose proportional .


The inter-individual variation of PK parameters was large .


The most frequent treatment-emergent adverse events were prolactin level increasing , injection site pain , tremor , dry mouth , and constipation .


The pharmacokinetics of paliperidone palmitate are linear with respect to time in Chinese subjects with schizophrenia at injections from 25 to 150mg eq .


Prasugrel is an antiplatelet agent that shows more prompt , potent , and consistent platelet inhibition than clopidogrel .


The objective of this study was to confirm the efficacy and safety of prasugrel at loading/maintenance doses of 20/3 .75 mg .


Japanese patients ( n = 1,363 ) with acute coronary syndrome undergoing percutaneous coronary intervention were randomized to either prasugrel ( 20/3 .75 mg ) or clopidogrel ( 300/75 mg ) , both in combination with aspirin ( 81-330 mg for the first dose and 81-100 mg/day thereafter ) , for 24-48 weeks .


The primary efficacy endpoint was the incidence of major adverse cardiovascular events ( MACE ) at 24 weeks , defined as a composite of cardiovascular death , nonfatal myocardial infarction , and nonfatal ischemic stroke .


We compared the incidence of MACE between the 2 groups using point estimates .


Safety outcomes included the incidence of bleeding events until 2 weeks after the last dose .


The incidence of MACE at 24 weeks was 9.4 % in the prasugrel group and 11.8 % in the clopidogrel group ( risk reduction 23 % , hazard ratio 0.77 , 95 % confidence interval 0.56-1 .07 ) .


The incidence of non-coronary artery bypass graft-related major bleeding was similar in both groups ( 1.9 % vs. 2.2 % ) .


Prasugrel 20/3 .75 mg was associated with a low incidence of ischemic events , similar to the results of TRITON-TIMI 38 , and with a low risk of clinically serious bleeding in Japanese ACS patients .


Bivalirudin , with selective use of glycoprotein ( GP ) IIb/IIIa inhibitor agents , is an accepted standard of care in primary percutaneous coronary intervention ( PPCI ) .


We aimed to compare antithrombotic therapy with bivalirudin or unfractionated heparin during this procedure .


In our open-label , randomised controlled trial , we enrolled consecutive adults scheduled for angiography in the context of a PPCI presentation at Liverpool Heart and Chest Hospital ( Liverpool , UK ) with a strategy of delayed consent .


Before angiography , we randomly allocated patients ( 1:1 ; stratified by age [ < 75 years vs 75 years ] and presence of cardiogenic shock [ yes vs no ] ) to heparin ( 70 U/kg ) or bivalirudin ( bolus 075 mg/kg ; infusion 175 mg/kg per h ) .


Patients were followed up for 28 days .


The primary efficacy outcome was a composite of all-cause mortality , cerebrovascular accident , reinfarction , or unplanned target lesion revascularisation .


The primary safety outcome was incidence of major bleeding ( type 3-5 as per Bleeding Academic Research Consortium definitions ) .


This study is registered with ClinicalTrials.gov , number NCT01519518 .


Between Feb 7 , 2012 , and Nov 20 , 2013 , 1829 of 1917 patients undergoing emergency angiography at our centre ( representing 97 % of trial-naive presentations ) were randomly allocated treatment , with 1812 included in the final analyses .


751 ( 83 % ) of 905 patients in the bivalirudin group and 740 ( 82 % ) of 907 patients in the heparin group had a percutaneous coronary intervention .


The rate of GP IIb/IIIa inhibitor use was much the same between groups ( 122 patients [ 13 % ] in the bivalirudin group and 140 patients [ 15 % ] in the heparin group ) .


The primary efficacy outcome occurred in 79 ( 87 % ) of 905 patients in the bivalirudin group and 52 ( 57 % ) of 907 patients in the heparin group ( absolute risk difference 30 % ; relative risk [ RR ] 152 , 95 % CI 109-213 , p = 001 ) .


The primary safety outcome occurred in 32 ( 35 % ) of 905 patients in the bivalirudin group and 28 ( 31 % ) of 907 patients in the heparin group ( 04 % ; 115 , 070-189 , p = 059 ) .


Compared with bivalirudin , heparin reduces the incidence of major adverse ischaemic events in the setting of PPCI , with no increase in bleeding complications .


Systematic use of heparin rather than bivalirudin would reduce drug costs substantially .


Liverpool Heart and Chest Hospital , UK National Institute of Health Research , The Medicines Company , AstraZeneca , The Bentley Drivers Club ( UK ) .


Partial weight supported treadmill gait training ( PWSTT ) is widely used in rehabilitation of gait in patient with Parkinsons Diseases ( PD ) .


However , its effect on blood pressure variability ( BPV ) and baroreflex sensitivity ( BRS ) in PD has not been studied .


To evaluate the effect of conventional and treadmill gait training on BPV components and BRS .


Sixty patients with idiopathic PD were randomized into three groups .


Twenty patients in control group were on only stable medication , 20 patients in conventional gait training ( CGT ) group ( Stable medication with CGT ) and 20 patients in PWSTT group ( Stable medication with 20 % PWSTT ) .


The CGT and PWSTT sessions were given for 30 min per day , 4 days per week , for 4 weeks ( 16 sessions ) .


Groups were evaluated in their best ON states .


The beat-to-beat finger blood pressure ( BP ) was recorded for 10 min using a Finometer instrument ( Finapres Medical Systems , The Netherlands ) .


BPV and BRS results were derived from artifact-free 5-min segments using Nevrocard software .


BRS showed a significant group with time interaction ( F = 6.930 ; p = 0.003 ) .


Post-hoc analysis revealed that PWSTT group showed significant improvement in BRS ( p < 0.001 ) after 4 weeks of training .


No significant differences found in BPV parameters ; systolic BP , diastolic BP , co-variance of systolic BP and low frequency component of systolic BP .


Four weeks of PWSTT significantly improves BRS in patients with PD .


It can be considered as a non-invasive method of influencing BRS for prevention of orthostatic BP fall in patients with PD .


To determine the impact of late radiation-induced toxicity on health-related quality of life ( HRQoL ) among patients with prostate cancer .


The study sample was composed of 227 patients , treated with external beam radiotherapy .


Common Terminology Criteria for Adverse Events version 3.0 were used to grade late genitourinary and gastrointestinal toxicity .


The European Organization for Research and Treatment of Cancer Quality of life Questionnaire C30 ( EORTC QLQ-C30 ) was used to assess HRQoL at baseline , and 6 , 12 and 24 months after completion of radiotherapy .


Statistical analysis was performed using a multivariate analysis of variance ( MANOVA ) .


Urinary incontinence and rectal discomfort significantly affected HRQoL .


The impact of urinary incontinence on HRQoL was most pronounced 6 months after radiotherapy and gradually decreased over time .


The impact of rectal discomfort on HRQoL was predominant at 6 months after radiotherapy , decreased at 12 months and increased again 2 years after radiotherapy .


No significant impact on HRQoL was observed for any of the other toxicity endpoints , or non-toxicity related factors such as hormonal therapy , radiotherapy technique or age .


Urinary incontinence and rectal discomfort have a significant impact on HRQoL .


Prevention of these side effects may likely improve quality of life of prostate cancer patients after completion of treatment .


The purpose of this single-institution pilot study was to evaluate the feasibility and safety of an oil-based skin agent , Ultra Emu Oil , on skin-related toxicity in patients undergoing radiation therapy to the breast or chest wall .


Patients were randomized 2:1 in a double-blind fashion and were instructed to apply processed Ultra Emu Oil or placebo ( cottonseed oil ) twice daily during the course of radiation therapy .


The oils were applied before the third fraction and continued for 6 weeks after completion of treatment .


The primary endpoint was the area under the curve ( AUC ) of Skindex-16 scale scores over time .


Secondary outcomes included maximum grade of radiation dermatitis using the Common Terminology Criteria ( CTC ) for Adverse Events ( CTCAE 3.0 ) , the Skin Toxicity Assessment Tool , quality of life ( QOL ) measured by Linear Analogue Self-Assessment , and a symptom experience diary ( SED ) .


In all , 42 of 45 patients completed the study and were evaluable .


The median times to peak rash , skin redness , peeling , and skin swelling were weeks 6 , 6 , 7 , and 7 , respectively as measured by the SED .


The Skindex AUC scores tended to be lower in emu oil patients than in placebo patients ( mean total AUC 7.2 vs 10.4 , respectively ) .


This trend was also seen in all the Skindex subdomains .


The overall QOL was slightly better in the emu oil group but remained stable throughout the study for both arms .


Peak CTC toxicity occurred at week 6 .


Patients using emu oil appeared slightly worse on maximum CTC grade , but the difference was not significant .


This pilot study confirmed the safety of oil-based skin treatments during radiation therapy and suggests a trend for reduced skin toxicity for patients receiving emu oil .


A larger study is needed to evaluate the efficacy of emu oil in reducing radiation dermatitis in patients receiving breast radiation .


Behavioural lifestyle interventions can be effective at promoting initial weight loss and supporting physical activity and dietary behaviour change , however maintaining improvements in these outcomes is often more difficult to achieve .


Extending intervention contact to reinforce learnt behavioural skills has been shown to improve maintenance of behaviour change and weight loss .


This trial aims to evaluate the feasibility , acceptability and efficacy of a text message-delivered extended contact intervention to enhance or maintain change in physical activity , dietary behaviour and weight loss among participants who have completed a six month Government-funded , population-based telephone coaching lifestyle program : the Get Healthy Information and Coaching Service ( GHS ) .


GHS completers will be randomised to the 6-month extended contact intervention ( Get Healthy , Stay Healthy , GHSH ) or a no contact control group ( standard practice following GHS completion ) .


GHSH participants determine the timing and frequency of the text messages ( 3-13 per fortnight ) and content is tailored to their behavioural and weight goals and support preferences .


Two telephone tailoring calls are made ( baseline , 12-weeks ) to facilitate message tailoring .


Primary outcomes , anthropometric ( body weight and waist circumference via self-report ) and behavioural ( moderate-vigorous physical activity via self-report and accelerometer , fruit and vegetable intake via self-report ) , will be assessed at baseline ( at GHS completion ) , 6-months ( end of extended contact intervention ) and 12-months ( 6-months post intervention contact ) .


Secondary aims include evaluation of : the feasibility of program delivery ; the acceptability for participants ; theoretically-guided , potential mediators and moderators of behaviour change ; dose-responsiveness ; and , costs of program delivery .


Findings from this trial will inform the delivery of the GHS in relation to the maintenance of behaviour change and weight loss , and will contribute to the broader science of text message lifestyle interventions delivered in population health settings .


ACTRN12613000949785 .


Mineralocorticoid receptor antagonists improve outcomes in patients with systolic heart failure but may induce worsening of renal function ( WRF ) and hyperkalemia ( HK ) .


We assessed the risk factors for mineralocorticoid receptor antagonist-related WRF and for HK , as well as the association between HK and WRF with clinical outcomes in the Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure ( EMPHASIS-HF ) .


Serial changes in estimated glomerular filtration rate and in serum potassium were available in 2737 patients during a median 21-month follow-up .


HK variably defined as serum K > 4.5 , 5 , or 5.5 mmol/L occurred in 74.7 % , 32.5 % , and 8.9 % patients enrolled in EMPHASIS-HF , respectively .


WRF defined as a decrease in estimated glomerular filtration rate > 20 % or > 30 % from baseline occurred in 27 % and 14 % of patients , respectively .


Patients assigned eplerenone displayed modest and early but significant and persistent ( 1 ) rise in serum potassium and ( 2 ) reduction in estimated glomerular filtration rate when compared with those assigned placebo .


In multivariate analyses , eplerenone was associated with a higher incidence of WRF and HK , which were interrelated and also associated with baseline patient characteristics ( eg , age75 years , hypertension , diabetes mellitus , nonwhite race , ejection fraction < 30 % , and treatment with an antiarrythmics drug or loop diuretic ) .


Eplerenone retained its survival benefits without any significant interaction with the association between HK > 5.5 mmol/L only and WRF and worse outcomes .


In patients with heart failure receiving optimal therapy , WRF and HK were more frequent when eplerenone was added , but their occurrence did not eliminate the survival benefit of eplerenone .


URL : http://www.clinicaltrials.gov .


Unique identifier : NCT00232180 .


Many primary care patients with raised blood pressure or depression drink potentially hazardous levels of alcohol .


Brief interventions ( BI ) to reduce alcohol consumption may improve comorbid conditions and reduce the risk of future alcohol problems .


However , research has not established their effectiveness in this patient population .


This study aimed to establish the feasibility of definitive trials of BI to reduce excessive drinking in primary care patients with hypertension or mild to moderate depression .


Thirteen general practices in North East England were randomized to the intervention or control arm of one of two parallel pilot trials .


Adult patients drinking excessively and diagnosed with hypertension or mild-to-moderate depression received the Alcohol Use Disorders Identification Test ( AUDIT ) by postal survey .


Consenting respondents scoring more than 7 on AUDIT ( score range 0 to 40 ) received brief alcohol consumption advice plus an information leaflet ( intervention ) or an information leaflet alone ( control ) with follow-up at six months .


Measurements included the numbers of patients eligible , recruited , and retained , and the AUDIT score and systolic/diastolic blood pressure of each patient or the nine-item Patient Health Questionnaire ( PHQ-9 ) score .


Acceptability was assessed via practitioner feedback and patient willingness to be screened , recruited , and retained at follow-up .


In the hypertension trial , 1709 of 33,813 adult patients ( 5.1 % ) were eligible and were surveyed .


Among the eligible patients , 468 ( 27.4 % ) returned questionnaires ; 166 ( 9.6 % of those surveyed ) screened positively on AUDIT and 83 ( 4.8 % of those surveyed ) were recruited ( 50.0 % of positive screens ) .


Sixty-seven cases ( 80.7 % of recruited patients ) completed follow-up at six months .


In the depression trial , 1,044 of 73,146 adult patients ( 1.4 % ) were eligible and surveyed .


Among these eligible patients , 215 ( 20.6 % ) responded ; 104 ( 10.0 % of those surveyed ) screened positively on AUDIT and 29 ( 2.8 % of those surveyed ) were recruited ( 27.9 % of positive screens ) .


Nineteen cases ( 65.5 % of recruited patients ) completed follow-up at six months .


Recruitment and retention rates were higher in the hypertension trial than in the depression trial .


A full brief intervention trial appears feasible for primary care patients with hypertension who drink excessively .


High AUDIT scores in the depression trial suggest the importance of alcohol intervention in this group .


However , future work may require alternative screening and measurement procedures .


Current Controlled Trials ISRCTN89156543 ; registered 21 October 2013 .


Physicians are expected to serve as role models for healthy lifestyles , but long work hours reduce time for healthy behaviors .


A hospital-based physical activity intervention could improve physician health and increase counseling about exercise .


We conducted a two-phase intervention among 104 medical residents at a large hospital in Boston , Massachusetts .


Phase 1 was a 6-week randomized controlled trial comparing daily steps of residents assigned to an activity monitor displaying feedback about steps and energy consumed ( intervention ) or to a blinded monitor ( control ) .


Phase 2 immediately followed and was a 6-week non-randomized team steps competition in which all participants wore monitors with feedback .


Phase 1 outcomes were : 1 ) median steps/day and 2 ) proportion of days activity monitor worn .


The Phase 2 outcome was mean steps/day on days monitor worn ( 500 steps/day ) .


Physiologic measurements were collected at baseline and study end .


Median steps/day were compared using Wilcoxon rank-sum tests .


Mean steps were compared using repeated measures regression analyses .


In Phase 1 , intervention and control groups had similar activity ( 6369 vs. 6063 steps/day , p = 0.16 ) and compliance with wearing the monitor ( 77 % vs. 77 % of days , p = 0.73 ) .


In Phase 2 ( team competition ) , residents recorded more steps/day than during Phase 1 ( CONTROL : 7,971 vs. 7,567 , p = 0.002 ;


7,832 vs. 7,739 , p = 0.13 ) .


Mean compliance with wearing the activity monitor decreased for both groups during Phase 2 compared to Phase 1 ( 60 % vs. 77 % , p < 0.001 ) .


Mean systolic blood pressure decreased ( p = 0.004 ) and HDL cholesterol increased ( p < 0.001 ) among all participants at end of study compared to baseline .


Although the activity monitor intervention did not have a major impact on activity or health , the high participation rates of busy residents and modest changes in steps , blood pressure , and HDL suggest that more intensive hospital-based wellness programs have potential for promoting healthier lifestyles among physicians .


Clinicaltrials.gov NCT01287208 .


Postoperative delirium is common in patients recovering from cardiac surgery .


Tight glucose control has been shown to reduce mortality and morbidity .


Therefore , the authors sought to determine the effect of tight intraoperative glucose control using a hyperinsulinemic-normoglycemic clamp approach on postoperative delirium in patients undergoing cardiac surgery .


The authors enrolled 198 adult patients having cardiac surgery in this randomized , double-blind , single-center trial .


Patients were randomly assigned to either tight intraoperative glucose control with a hyperinsulinemic-normoglycemic clamp ( target blood glucose , 80 to 110 mg/dl ) or standard therapy ( conventional insulin administration with blood glucose target , < 150 mg/dl ) .


Delirium was assessed using a comprehensive delirium battery .


The authors considered patients to have experienced postoperative delirium when Confusion Assessment Method testing was positive at any assessment .


A positive Confusion Assessment Method was defined by the presence of features 1 ( acute onset and fluctuating course ) and 2 ( inattention ) and either 3 ( disorganized thinking ) or 4 ( altered consciousness ) .


Patients randomized to tight glucose control were more likely to be diagnosed as being delirious than those assigned to routine glucose control ( 26 of 93 vs. 15 of 105 ; relative risk , 1.89 ; 95 % CI , 1.06 to 3.37 ; P = 0.03 ) , after adjusting for preoperative usage of calcium channel blocker and American Society of Anesthesiologist physical status .


Delirium severity , among patients with delirium , was comparable with each glucose management strategy .


Intraoperative hyperinsulinemic-normoglycemia augments the risk of delirium after cardiac surgery , but not its severity .


School-aged children suffer high rates of influenza virus infections and associated illnesses each year , and are a major source of transmission in the community .


However , information on the cumulative incidence of infection in specific epidemics is scarce , and there are limited studies with sufficient follow-up to identify the strength and duration of protection against reinfection .


We randomly allocated children 5-17 years of age to receive trivalent inactivated influenza vaccine ( TIV ) or placebo from September 2009 through January 2010 , and then conducted follow-up for 3 years including regular collection of sera , symptom diaries , and collection of nose and throat swabs during illness episodes in participants or their household members .


Of 796 children initially randomized , 484 continued to participate for all 3 years .


In unvaccinated children , cumulative incidence of infection was estimated to be 59 % in the first wave of H1N1pdm09 in 2009-2010 , and 7 % , 14 % , 20 % , and 31 % in subsequent epidemics of H3N2 ( 2010 ) , H1N1pdm09 ( 2011 ) , B ( 2012 ) , and H3N2 ( 2012 ) , respectively .


Infection with H1N1pdm09 in 2009-2010 and H3N2 in 2010 was associated with protection against infection with subsequent epidemics of the same subtype in 2011 and 2012 , respectively , but we found no evidence of heterotypic or heterosubtypic protection against infection .


We identified substantial incidence of influenza virus infections in children in Hong Kong in 5 major epidemics over a 3-year period , and evidence of homosubtypic but not heterosubtypic protection following infection .


NCT00792051 .


To construct and internally validate a risk score , the ' 80 + score ' , for revisits to hospital and mortality for older patients , incorporating aspects of pharmacotherapy .


Our secondary aim was to compare the discriminatory ability of the score with that of three validated tools for measuring inappropriate prescribing : Screening Tool of Older Person 's Prescriptions ( STOPP ) , Screening Tool to Alert doctors to Right Treatment ( START ) and Medication Appropriateness Index ( MAI ) .


Two acute internal medicine wards at Uppsala University hospital .


Patient data were used from a randomised controlled trial investigating the effects of a comprehensive clinical pharmacist intervention .


Data from 368 patients , aged 80years and older , admitted to one of the study wards .


Time to rehospitalisation or death during the year after discharge from hospital .


Candidate variables were selected among a large number of clinical and drug-specific variables .


After a selection process , a score for risk estimation was constructed .


The 80 + score was internally validated , and the discriminatory ability of the score and of STOPP , START and MAI was assessed using C-statistics .


Seven variables were selected .


Impaired renal function , pulmonary disease , malignant disease , living in a nursing home , being prescribed an opioid or being prescribed a drug for peptic ulcer or gastroesophageal reflux disease were associated with an increased risk , while being prescribed an antidepressant drug ( tricyclic antidepressants not included ) was linked to a lower risk of the outcome .


These variables made up the components of the 80 + score .


The C-statistics were 0.71 ( 80 + ) , 0.57 ( STOPP ) , 0.54 ( START ) and 0.63 ( MAI ) .


We developed and internally validated a score for prediction of risk of rehospitalisation and mortality in hospitalised older people .


The score discriminated risk better than available tools for inappropriate prescribing .


Pending external validation , this score can aid in clinical identification of high-risk patients and targeting of interventions .


An antagonist ( MK-7123 ) of the cytokine receptor CXCR2 reduces neutrophil chemotaxis and thus may alleviate airway inflammation in chronic obstructive pulmonary disease ( COPD ) .


To assess the efficacy , safety , and tolerability of three dose levels of MK-7123 , compared with placebo , in patients with moderate to severe COPD .


This 6-month , double-blind study randomized patients with moderate to severe COPD ( already on standard therapy ) to daily MK-7123 at 10 , 30 , or 50 mg or placebo .


The primary endpoint was change from baseline in post-bronchodilator FEV1 .


A total of 616 patients ( 71 % male ; mean age , 63 yr ; 45 % current smokers ; baseline FEV1 [ SD ] , 1.43 L [ 0.45 ] ; mean FEV1 percent predicted , 43.9 % ) were randomized .


Only MK-7123 50 mg led to significant improvement in FEV1 over placebo ( mean difference [ SE ] , 67 ml [ 32 ] ) .


Reduced sputum neutrophil count was observed among the 122 patients examined ; P = 0.003 ( 3 mo ) and P = 0.092 ( 6 mo ) ( MK-7123 50 mg vs. placebo ) .


The stratum of current smokers , but not that of nonsmokers , showed significant improvement versus placebo in FEV1 ( 168 ml ) and time-to-first exacerbation , and showed numerical improvement in St. George 's Respiratory Questionnaire for COPD score .


MK-7123 caused a dose-dependent decrease in absolute neutrophil count ( ANC ) and reduced inflammatory biomarkers matrix metallopeptidase-9 and myeloperoxidase in plasma and sputum ; ANC lower than 1.510 ( 9 ) / L led to discontinuations with higher doses of MK-7123 ( 18 % in the MK-7123 50-mg group vs. 1 % in placebo ) .


Plasma C-reactive protein and fibrinogen increased with MK-7123 treatment .


Rates of infections at 6 months were similar in all groups .


Treatment with MK-7123 50 mg versus placebo led to significant improvement in FEV1 in patients with COPD , suggesting clinically important antiinflammatory effects with CXCR2 antagonism , although dose-related discontinuations were observed because of ANC decreases with MK-7123 .


Greater response was observed in smokers versus ex-smokers .


Clinical trial registered with www.clinicaltrials.gov ( NCT 01006616 ) .


Single-blinded randomized controlled pilot study .


To examine the changes in pectoralis minor length ( PML ) , the supine measurement of rounded shoulder posture ( RSP ) , and the total scapular distance ( TSD ) in seated male workers with RSP , after rounded-shoulder-taping ( RST ) using kinesiology tape with ( experimental taping ) and without stretch ( placebo taping ) .


RSP , a postural impairment , is a known cause of upper quarter pain .


Fourteen men with RSP , who worked for at least 7h/d in a seated position , were selected for RST , with the shoulders randomly assigned to two kinesiology taping methods : ( 1 ) with 35-40 % stretch of its original length ; and ( 2 ) without stretch .


The PML , supine measurements of RSP , and TSD , before and after kinesiology taping , with and without stretch , were assessed .


Kinesiology taping with stretch significantly increased the PML and significantly decreased the supine measurement of RSP and TSD ; kinesiology taping without stretch did not increase the PML significantly and did not decrease the supine measurement of RSP and TSD .


RST using kinesiology tape with stretch produces immediate mechanical correction of RSP in seated male workers .


Transradial intervention ( TRI ) and bivalirudin infusion compared with transfemoral coronary intervention or unfractionated heparin plus glycoprotein IIb/IIIa inhibitors decrease bleeding complications in patients with acute coronary syndromes ( ACS ) .


Although bleeding is thought to be associated with worse outcomes , it remains unclear whether TRI and bivalirudin both independently lower ischemic or combined ischemic and bleeding complications in ACS patients undergoing contemporary invasive management .


The primary objectives of the MATRIX program are to assess whether TRI or bivalirudin as compared , respectively , with transfemoral coronary intervention ( MATRIX access site ) or unfractionated heparin plus provisional glycoprotein IIb/IIIa inhibitors , ( MATRIX antithrombin ) decrease the 30-day incidence of an ischemic ( ie , death , myocardial infarction or stroke ) or an ischemic and bleeding composite end point across the whole spectrum of ACS patients , including clarifying the optimal duration of bivalirudin infusion after percutaneous coronary intervention ( MATRIX treatment duration ) .


The MATRIX ( NCT01433627 ) study , which incorporates 3 randomized comparisons in a nonfactorial manner and primary end points at 30 days and clinical follow-up 1 year , is a large-scale , multicenter study with blind event adjudication conducted at approximately 100 European sites .


With 8,200 patients in the randomized comparison of access sites and 6,800 individuals participating in the randomized comparison of antithrombin regimens , this study will have 85 % power for the primary end points .


The MATRIX program aims at conclusively ascertaining the role of TRI and bivalirudin infusion in the whole spectrum of ACS patients undergoing contemporary invasive management .


A 3-month topical application of clobetasol propionate ( CP ) represents the recommended and accepted first-line treatment for vulvar lichen sclerosus ( VLS ) ; however , to date , no randomized controlled trials have compared the efficacy and safety of CP with other topical corticosteroids .


To compare the effectiveness and tolerability of two different topical corticosteroids , CP 005 % ointment and mometasone furoate ( MMF ) 01 % ointment , in the treatment of VLS .


Fifty-four patients with VLS were enrolled in a 12-week active treatment phase ( ATP ) and randomized to apply either CP or MMF in a tapering regimen .


The main efficacy parameters were the response rate , the rate of patients achieving an improvement from baseline of 75 % in the subjective and objective scores , and the mean reduction in subjective and objective scores throughout the treatment .


By the end of the 12-week ATP , 24 ( 89 % ) patients were considered to be responders among the CP patients and 24 ( 89 % ) among the MMF patients ; 59 % and 37 % of patients in the CP group and 67 % and 48 % in the MMF group achieved an improvement of at least 75 % in subjective and objective scores , respectively .


The decrease in mean symptom and sign scores was significant compared with baseline with both treatments .


No significant differences were found in any of the assessed efficacy endpoints between CP and MMF .


Both treatments were well tolerated .


Clobetasol propionate and MMF appeared similarly efficacious and well tolerated for the treatment of VLS and both may represent the first-line treatment for the disease .


The aim of this study was to analyze the long-term survival of AML patients with CEBPA mutations .


We investigated 88 AML patients with a median age of 61years and ( 1 ) cytogenetically normal AML ( CN-AML ) , ( 2 ) monoallelic ( moCEBPA ) or biallelic ( biCEBPA ) CEBPA mutation , and ( 3 ) intensive induction treatment .


60/88 patients have been described previously with a shorter follow-up .


Median follow-up time was 9.8 years ( 95 % CI : 9.4-10 .1 years ) compared to 3.2 and 5.2 years in our former analyses .


Patients with biCEBPA mutations survived significantly longer compared to those with moCEBPA ( median overall survival ( OS ) 9.6 years vs. 1.7 years , p = 0.008 ) .


Patients60years and biCEBPA mutations showed a favorable prognosis with a 10-year OS rate of 81 % .


In this long-term observation we confirmed the favorable prognostic outcome of patients with biCEBPA mutations compared to moCEBPA-mutated CN-AML .


The high probability of OS ( 81 % ) in younger patients is helpful to guide intensity of postremission therapy .


A simple approach is the predominant strategy for the percutaneous coronary intervention of bifurcation lesions .


Performing side branch ( SB ) predilation in this context is currently a matter of controversy .


In this study , we assess the efficacy of SB predilatation before a provisional T-stent strategy for bifurcation lesions .


Between February 2009 and November 2012 , 372 patients with true bifurcation lesions were randomized to either predilation of the SB ( n = 187 ) or no predilatation ( n = 185 ) before main branch ( MB ) stent implantation and a subsequent SB provisional stent strategy .


There were no significant differences between the patient groups regarding the baseline characteristics .


After MB stent implantation , the TIMI flow of the SB was higher in the patients with SB predilation : TIMI flow 0 to 1 ; 2 ( 1 % ) versus 18 ( 10 % ) , P < .001 ; and TIMI flow III ; 179 ( 96 % ) versus 152 ( 82 % ) , P < .001 .


Side branch stenting rates were 4 % versus 3 % , P = not significant .


In addition , 60 patients ( 32 % ) from the SB predilation group presented SB residual stenosis by visual inspection < 50 % , and TIMI flow III did not require any additional treatment .


The failure rate of SB rewiring , the time of rewiring , the number of wires used , and the incidence of major events were similar in both groups of patients .


Predilation of the SB resulted in improved TIMI flow after MB stenting and less indication to subsequently treat the SB .


If rewiring of the SB is required , predilation did not hinder this maneuver .


This study sought to assess the effectiveness of a secondhand tobacco smoke ( SHS ) prevention program based on an expanded Health Belief Model ( HBM ) incorporating self-efficacy among pregnant women in a hospital setting in Taiwan .


This study utilized a two-group longitudinal randomized controlled trial design .


Participants in the intervention group ( n = 50 ) enrolled in a SHS prevention program based on the HBM , while participants in the comparison group ( n = 50 ) received standard government-mandated counseling care .


Both groups were given questionnaires as a pre-test , two weeks into the intervention , and one month following the conclusion of the intervention .


The questionnaire and intervention were developed based on the understanding gained through a series of in-depth interviews and a focus-group conducted among pregnant women .


Exhaled carbon monoxide was also measured and used as a proxy for SHS exposure .


Intervention group scores were all significantly higher than comparison group scores ( p < 0.001 ) , indicating a significant increase in knowledge , HBM scores , cues to action , self-efficacy , preventative behaviors , and a significant decrease in smoking exposure .


These differences remained significant at the one-month follow-up assessment ( p < 0.001 ) .


These results should encourage health professionals to educate pregnant women regarding the harms of SHS while both empowering and equipping them with the tools to confront their family members and effectively reduce their SHS exposure while promoting smoke-free social norms .


Isoflavones and exercise have been shown to affect C-reactive protein ( CRP ) and body composition and to act synergistically on trunk and total fat mass ( FM ) , glucose metabolism , and lean body mass in postmenopausal women with a body mass index higher than 25 kg/m .


We hypothesized that exercise and isoflavone supplementation ( Ex + ISO ) could reduce inflammation in the same subpopulation of women .


The objective of this study was to investigate if 6 months of mixed exercise combined with isoflavones could have greater effects on specific inflammatory markers than exercise alone in overweight or obese postmenopausal women .


Thirty-four postmenopausal women aged 50 to 70 years were randomly assigned to exercise and placebo ( Ex + PLA ; n = 15 ) or Ex + ISO ( n = 19 ) .


At baseline and after 6 months , waist circumference , hip circumference , total FM , trunk FM , leg FM , and muscle mass index ( MMI ; = total fat free mass [ kg ] / height [ m ] ) were assessed ( dual-energy x-ray absorptiometry ) .


Inflammatory markers ( CRP , tumor necrosis factor - [ TNF - ] , and interleukin-6 ) were obtained by enzyme-linked immunosorbent assay .


T tests were used to compare groups at baseline .


The Ex + PLA group showed significant changes in MMI ( +0.33 kg/m , P 0.009 ) and FM compartments ( waist circumference , -5.13 cm ; % FM , -1.31 % ; P 0.001 ) , whereas inflammation remained unchanged .


However , the Ex + ISO group showed significant changes in total FM ( -1.70 kg , P < 0.0001 ) , FM compartments ( hip circumference [ -2.51 cm , P = 0.019 ] , leg FM [ -1.16 kg , P = 0.037 ] , and trunk FM [ -0.72 kg , P = 0.006 ] ) , MMI ( +0.39 kg , P = 0.011 ) , and inflammation ( CRP , -1.14 mg/L , P = 0.029 ; TNF - , +0.29 pg/mL , P = 0.010 ) .


Despite an increase in TNF - , the use of isoflavones-when body weight remains stable-seems to enhance the beneficial effects of mixed-exercise training on body composition and CRP in overweight or obese postmenopausal women .


Although feedback conversations are an essential component of learning , three challenges make them difficult : the fear that direct task feedback will harm the relationship with the learner , overcoming faculty cognitive biases that interfere with their eliciting the frames that drive trainees ' performances , and time pressure .


Decades of research on developmental conversations suggest solutions to these challenges : hold generous inferences about learners , subject one 's own thinking to test by making it public , and inquire directly about learners ' cognitive frames .


The authors conducted a randomized , controlled trial to determine whether a 1-h educational intervention for anesthesia faculty improved feedback quality in a simulated case .


The primary outcome was an analysis of the feedback conversation between faculty and a simulated resident ( actor ) by using averages of six elements of a Behaviorally Anchored Rating Scale and an objective structured assessment of feedback .


Seventy-one Harvard faculty anesthesiologists from five academic hospitals participated .


The intervention group scored higher when averaging all ratings .


Scores for individual elements showed that the intervention group performed better in maintaining a psychologically safe environment ( 4.3 1.21 vs. 3.8 1.16 ; P = 0.001 ) , identifying and exploring performance gaps ( 4.1 1.38 vs. 3.7 1.34 ; P = 0.048 ) , and they more frequently emphasized the professionalism error of failing to call for help over the clinical topic of anaphylaxis ( 66 vs. 41 % ; P = 0.008 ) .


Quality of faculty feedback to a simulated resident was improved in the interventional group in a number of areas after a 1-h educational intervention , and this short intervention allowed a group of faculty to overcome enough discomfort in addressing a professionalism lapse to discuss it directly .


The effect of ibuprofen on pain tolerance during exercise is controversial , and its effects on endurance performance have been poorly investigated .


To investigate the effect of prophylactic administration of the nonsteroidal anti-inflammatory drug ibuprofen on the time until the self-report of fatigue ( tlim ) in runners with exercise-induced muscle damage .


Randomized controlled clinical trial .


Laboratory .


Twenty healthy male long-distance runners ( age = 18.8 0.4 years , maximal oxygen consumption = 55.5 5.9 mLkg ( -1 ) min ( -1 ) ) .


Participants were assigned to 2 groups ( ibuprofen group = 10 , placebo group = 10 ) to perform tlim trials ( speed corresponded to their previously determined secondventilatory thresholds ) 48 hours before and 48 hours after the induction of a lower limb muscle-damage protocol ( isokinetic dynamometry ) .


One hour before the second tlim trial , the ibuprofen group received 1.2 g ibuprofen , and the placebo group received lactose orally .


Time until self-reported fatigue , heart rate , respiratory quotient , oxygen consumption , and perceived exertion were recorded during each tlim test .


Both groups reported increases in muscle pain in the knee extensors and flexors 48 hours after the muscle-damage protocol .


We observed a reduction in the endurance performance of both groups ( P < .01 ) but no difference between groups ( P = .55 ) .


Ibuprofen did not reduce the effect of muscle damage and pain on performance .


Prophylactic use of nonsteroidal anti-inflammatory drugs did not have an ergogenic effect on running performance after exercise-induced muscle damage in male long-distance runners .


Caregivers of people with chronic conditions are more likely than non-caregivers to have depression and emotional problems .


Few studies have examined the effectiveness of mindfulness-based stress reduction ( MBSR ) in improving their mental well-being .


Caregivers of persons with chronic conditions who scored 7 or above in the Caregiver Strain Index were randomly assigned to the 8-week MBSR group ( n = 70 ) or the self-help control group ( n = 71 ) .


Validated instruments were used to assess the changes in depressive and anxiety symptoms , quality of life , self-efficacy , self-compassion and mindfulness .


Assessments were conducted at baseline , post-intervention and at the 3-month follow-up .


Compared to the participants in the control group , participants in the MBSR group had a significantly greater decrease in depressive symptoms at post-intervention and at 3 months post-intervention ( p < 0.01 ) .


The improvement in state anxiety symptoms was significantly greater among participants in the MBSR group than those of the control group at post-intervention ( p = 0.007 ) , although this difference was not statistically significant at 3 months post-intervention ( p = 0.084 ) .


There was also a statistically significant larger increase in self-efficacy ( controlling negative thoughts ; p = 0.041 ) and mindfulness ( p = 0.001 ) among participants in the MBSR group at the 3-month follow-up compared to the participants in the control group .


No statistically significant group effects ( MBSR vs. control ) were found in perceived stress , quality of life or self-compassion .


MBSR appears to be a feasible and acceptable intervention to improve mental health among family caregivers with significant care burden , although further studies that include an active control group are needed to make the findings more conclusive .


Pilot studies have suggested benefit from intravenous administration of bone marrow mononuclear stem cells ( BMSCs ) in stroke .


We explored the efficacy and safety of autologous BMSCs in subacute ischemic stroke .


This was a phase II , multicenter , parallel group , randomized trial with blinded outcome assessment that included 120 patients .


Patients with subacute ischemic stroke were randomly assigned to the arm that received intravenous infusion of autologous BMSCs or to control arm .


Coprimary clinical efficacy outcomes were Barthel Index score and modified Rankin scale at day 180 .


Secondary outcomes were change in infarct volume , National Institute of Health Stroke Scale ( NIHSS ) at day 90 and 180 .


Main safety outcomes were adverse events , any new area of ( 18 ) fluorodeoxyglucose positron emission tomography uptake in any body part over 365 days .


Fifty-eight patients received a mean of 280.75 million BMSCs at median of 18.5 days after stroke onset .


There was no significant difference between BMSCs arm and control arm in the Barthel Index score ( 63.1 versus 63.6 ; P = 0.92 ) , modified Rankin scale shift analysis ( P = 0.53 ) or score > 3 ( 47.5 % versus 49.2 % ; P = 0.85 ) , NIHSS score ( 6.3 versus 7.0 ; P = 0.53 ) , change in infarct volume ( -11.1 versus -7.36 ; P = 0.63 ) at day 180 .


Adverse events were also similar in the 2 arms , and no patient showed any new area of ( 18 ) fluorodeoxyglucose uptake .


With the methods used , results of this hitherto first randomized controlled trial indicate that intravenous infusion of BMSCs is safe , but there is no beneficial effect of treatment on stroke outcome .


URLs : http://ctri.nic.in/Clinicaltrials and http://www.clinicaltrials.gov .


Unique identifiers : CTRI-ROVCTRI/2008/091 / 0004 and NCT0150177 .


This investigation examined the ergogenic effect of short-term oral N-acetylcysteine ( NAC ) supplementation and the associated changes in redox balance and inflammation during intense training .


A double-blind randomized placebo-controlled crossover design was used to assess 9 d of oral NAC supplementation ( 1200 mgd ) in 10 well-trained triathletes .


For each supplement trial ( NAC and placebo ) , baseline venous blood and urine samples were taken , and a presupplementation cycle ergometer race simulation was performed .


After the loading period , further samples were collected preexercise , postexercise , and 2 and 24 h after the postsupplementation cycle ergometer race simulation .


Changes in total antioxidant capacity , ferric reducing ability of plasma , reduced glutathione , oxidized glutathione , thiobarbituric acid-reactive substances , interleukin 6 , xanthine oxidase , hypoxanthine , monocyte chemotactic protein 1 , nuclear factor B , and urinary 15-isoprostane F2t concentration were assessed .


The experimental procedure was repeated with the remaining supplement after a 3-wk washout .


Eight participants completed both supplementation trials .


NAC improved sprint performance during the cycle ergometer race simulation ( P < 0.001 , p = 0.03 ) .


Supplementation with NAC also augmented postexercise plasma total antioxidant capacity ( P = 0.005 , p = 0.19 ) , reduced exercise-induced oxidative damage ( plasma thiobarbituric acid-reactive substances , P = 0.002 , p = 0.22 ; urinary 15-isoprostane F2t concentration , P = 0.010 , p = 0.431 ) , attenuated inflammation ( plasma interleukin 6 , P = 0.002 , p = 0.22 ; monocyte chemotactic protein 1 , P = 0.012 , p = 0.17 ) , and increased postexercise nuclear factor B activity ( P < 0.001 , p = 0.21 ) .


Oral NAC supplementation improved cycling performance via an improved redox balance and promoted adaptive processes in well-trained athletes undergoing strenuous physical training .


We investigated the prevalence , incidence and predictors of new peripheral neuropathy episodes in previously untreated , symptomatic HIV-infected Ugandan/Zimbabwean adults initiating zidovudine-based antiretroviral therapy ( ART ) .


An open-label , multicentre , randomized trial .


Peripheral neuropathy was self-reported at 12-weekly clinic visits .


Cox regression models ( excluding participants reporting preexisting peripheral neuropathy at ART initiation ) , considered sex ; pre-ART WHO stage , age and CD4 ( + ) cell count ; CD4 ( + ) cell count versus no CD4 ( + ) cell count monitoring ; and time-updated CD4 ( + ) cell count , weight and use of stavudine , isoniazid and didanosine .


Four hundred and twenty-one out of 3316 ( 13 % ) patients reported preexisting peripheral neuropathy at ART initiation .


Median ( interquartile range , IQR ) follow-up in 2895 participants without preexisting peripheral neuropathy was 4.9 ( 4.7-5 .4 ) years .


Three hundred and fifty-four ( 12 % ) took stavudine as first-line substitution and 518 ( 18 % ) took isoniazid during follow-up .


Two hundred and ninety ( 11 % ) participants developed a new peripheral neuropathy episode , an incidence of 2.12 per 100 person-years .


Eighteen ( 0.1 % ) had a grade 3/4 episode .


Independent predictors of peripheral neuropathy were current stavudine use [ adjusted hazard ratio ( a ) HR 4.16 ( 95 % confidence interval , 95 % CI 3.06-5 .66 ] , current isoniazid use [ aHR 1.59 ( 95 % CI 1.02-2 .47 ) ] and current didanosine use [ aHR 1.60 ( 95 % CI 1.19-2 .14 ) ] .


Higher risks were independently associated with higher pre-ART weight [ aHR ( per +5 kg ) 1.07 ( 95 % CI 1.01-1 .13 ) ] and older age aHR ( per 10 years older ) 1.29 ( 95 % CI 1.12-1 .49 ) , but there was no significant effect of sex ( P = 0.13 ) , pre-ART CD4 ( + ) cell count ( P = 0.91 ) or CD4 ( + ) cell count monitoring ( P = 0.73 ) .


Current stavudine , didanosine or isoniazid use continue to increase peripheral neuropathy risks , as does older age and weight at ART initiation ; however , we found no evidence of increased risk in women in contrast to previous studies .


The incidence of peripheral neuropathy may now be lower in ART programmes , as stavudine and didanosine are no longer recommended .


All patients receiving isoniazid , either as part of antituberculosis ( TB ) chemotherapy or TB-preventive therapy , should receive pyridoxine as recommended in national guidelines .


To observe the effects of different maintain doses of Dexmedetomidine on plasma cortisol and glucose during anesthesia recovery period in patients undergoing uvulopalatopharyngoplasty under sevoflurane inhalation anesthesia .


In this prospective , randomized , double-blind study , 120 ASA I and II patients undergoing selective uvulopalatopharyngoplasty under general anesthesia were included .


The patients were randomly allocated to three groups ( n = 40 ) : Dexmedetomidine low maintain dose group ( D1 ) , Dexmedetomidine high maintain dose group ( group D2 ) and control group ( group C ) .


The Dexmedetomidine groups and control group were given Dexmedetomidine 1 microg/kg and normal saline in 20 ml within 15 min just before induction of anesthesia .


Then Dexmedetomidine were maintained at 0.2 microg x kg ( -1 ) x h ( -1 ) and 0.7 microg x kg ( -1 ) x h ( -1 ) in group D1 and group D2 and were withdrawed 5 min before the end of operation , the same maintained speed of normal saline was given in group C. BIS value was maintained at 40-60 by adjusting the inhaled concentration of sevoflurane .


Anesthetic was withdrawed 10 min before the end of operation .


Thus , plasma cortisol concentration and blood glucose was needed to be detected just before anesthesia ( T0 ) , tracheal extubation ( T1 ) , 5 min after extubation ( T2 ) and 15 min after extubation ( T3 ) .


Duration of operation and anesthesia , consumption of sevoflurane , emergence time , extubation time , the occurrence of dysphoria , bucking and hypoxemia ( SpO2 < 90 % ) during extubation were recorded .


Compared with group C , MAP and HR at T1 , plasma cortisol concentration and blood glucose at T1 - T3 were all significantly lower in group D1 and group D2 ( P < 0.05 ) , and so were the consumption of sevoflurane and the occurrence of dysphoria ( P < 0.05 ) .


The emergence time and extubation time were significantly prolonged in group D2 compared with group D1 and group C ( P < 0.05 ) .


There was no significant difference in the occurrence of bucking and hypoxemia in three groups ( P > 0.05 ) .


In the patients undergoing UPPP under sevoflurane inhalation anesthesia , Dexmedetomidine infused at 0.2 microg x kg ( -1 ) x h ( -1 ) maintains a stable hemodynamics without respiratory depression , alleviates stress response during extubation and reduces both the consumption of sevoflurane and the occurrence of dysphoria without prolonging emergence time and extubation time .


We aimed to identify those patients with hepatitis C virus who benefit most from prophylactic treatment with selective serotonin reuptake inhibitors ( SSRIs ) during antiviral therapy .


We performed post hoc analyses on a prospective randomized controlled trial ( n = 79 ) of escitalopram versus placebo during antiviral therapy with pegylated interferon and ribavirin , conducted between August 2005 and June 2008 .


Our primary outcome measure was the association of baseline characteristics with the development of depression and/or depressive symptoms .


Further , we studied effects of prophylactic escitalopram on depressive symptoms .


Presence of a major depression was diagnosed using Mini-International Neuropsychiatric Interview ( MINI ) , a short , structured interview used to diagnose DSM-IV-TR and ICD-10 disorders .


Depressive symptoms were monitored during treatment by using the depression scale of Symptom Checklist-90 ( SCL-90 ) , Montgomery-Asberg Depression Rating Scale ( MADRS ) , and Beck Depression Inventory ( BDI ) at baseline and weeks 4 , 12 , and 24 of antiviral therapy .


Depression occurred in 14 patients receiving placebo and in 5 patients receiving escitalopram ( Pearson , P = .01 ) .


Combination of history of depression and intravenous drug use was associated with depression ( odds ratio = 12.60 ; 95 % CI , 2.47-64 .34 ; P < .01 ) .


Moreover , treatment with selective serotonin reuptake inhibitor compared to placebo was associated with a significant reduction in estimated mean depressive symptoms measured by SCL-90 ( P = .03 ) and BDI ( P = .048 ) , but not with MADRS ( P = .64 ) .


Patients infected by hepatitis C virus with a history of depression and intravenous drug use carry the highest risk to develop interferon-induced depression .


In this subset of patients , prophylaxis with escitalopram results in the most substantial decrease of interferon-induced depressive symptoms on the SCL-90 depression scale and the BDI .


One in 4 men in the United States aged > 50 years will have an osteoporosis-related fracture .


Fewer data are available on osteoporosis treatment in men than in women .


The purpose of this study was to evaluate denosumab therapy in men with low bone mineral density ( BMD ) .


This was a phase 3 study with 2 treatment periods : a previously reported 12-month double-blind , placebo-controlled phase and a 12-month open-label phase .


This was a multicenter study conducted in North America and Europe .


A total of 228 men entered the open-label phase and 219 completed the study .


Men from the original denosumab ( long-term ) and placebo ( crossover ) groups received 60 mg of denosumab sc every 6 months .


BMD , serum collagen type I C-telopeptide , and safety were measured .


During the open-label phase , continued BMD increases occurred with long-term denosumab treatment ( 2.2 % lumbar spine , 0.9 % total hip , 1.3 % femoral neck , 1.3 % trochanter , and 0.2 % 1/3 radius ) , resulting in cumulative 24-month gains from baseline of 8.0 % , 3.4 % , 3.4 % , 4.6 % , and 0.7 % , respectively ( all P < .01 ) .


The crossover group showed BMD gains after 12 months of denosumab treatment similar to those of the long-term denosumab group during the first treatment year .


Significant reductions in serum collagen type I C-teleopeptide were observed after denosumab administration .


Adverse event rates were similar between groups , and no new safety signals were identified .


In men with low BMD , denosumab treatment for a second year continued to increase BMD , maintained reductions in bone resorption , and was well tolerated .


BMD increased in men initiating denosumab during the second year .


These effects were similar to those previously seen in postmenopausal women with osteoporosis and in men with prostate cancer receiving androgen deprivation therapy .


Our recent pilot study demonstrated mindfulness-based cognitive therapy ( MBCT ) is a potentially efficacious headache pain treatment ; however , it was not universally effective for all participants .


This study sought to explore patient characteristics associated with MBCT treatment response and the potential processes of change that allowed treatment responders to improve and that were potentially lacking in the non-responders .


We implemented a mixed-methods analysis of quantitative and qualitative data .


The sample consisted of 21 participants , 14 of whom were classified as treatment responders ( 50 % improvement in pain intensity and/or pain interference ) and seven as non-responders ( < 50 % improvement ) .


The study was conducted at the Kilgo Headache Clinic and the University of Alabama Psychology Clinic .


Participants completed an 8-week MBCT treatment for headache pain management .


Standardized measures of pain , psychosocial outcomes , and non-specific therapy factors were obtained ; all participants completed a post-treatment semi-structured interview .


Quantitative data indicated a large effect size difference between responders and non-responders for pre - to post-treatment change in standardized measures of pain acceptance and catastrophizing , and a small to medium effect size differences on treatment dose indicators .


Both groups showed improved psychosocial outcomes .


Qualitatively , change in cognitive processes was a more salient qualitative theme within treatment responders ; both groups commented on the importance of non-specific therapeutic factors .


Barriers to mindfulness meditation were also commented on by participants across groups .


Results indicated that change in pain related cognitions during an MBCT intervention for headache pain is a key factor underlying treatment response .


Many stroke survivors would benefit from modification of their lifestyle in order to reduce their risk of recurrent stroke .


We investigated if tailored smoking cessation advice would yield a higher smoking cessation rate and a higher rate with sustained abstinence in ex-smokers in the intervention group than among controls .


Patients admitted with an acute stroke or a transient ischaemic attack were included in a randomised controlled trial focusing on control of lifestyle risk factors and hypertension .


Here , we report the intervention focused on smoking cessation .


We used multiple logistic regression analysis to identify patient characteristics associated with smoking cessation .


Analyses were by intention to treat excluding those who died or suffered severe disease .


We included 254 patients with a history of smoking .


Two years after inclusion , 15 of 57 ( 26 % ) baseline smokers in the intervention group had stopped smoking versus eight of 56 ( 14 % ) among controls ( p = 0.112 ) .


Living with a partner ( p = 0.012 ) , having at least ten years of education ( p = 0.012 ) , and not being exposed to smoking at home ( p = 0.036 ) were independent predictors of smoking cessation .


We did not achieve our aim of higher smoking cessation rates in the intervention group .


Future smoking cessation interventions should be more intensive , focus on patients ' social circumstances and , if possible , involve patients ' relatives .


This study was supported by the Ludvig and Sara Elsass Foundation , the Lundbeck Foundation and The Danish Heart Foundation ( Grant 07-4-B703-A1378-22384F ) .


This protocol is registered with Clinical Trials.gov ( NCT 00253097 ) .


To test the hypothesis that promoting breakfast cereal consumption , as part of a web-based programme , results in loss of body mass .


Single centre , single blind , randomised parallel study .


Test group followed a fully interactive website ( B ) with ` prescribed ' breakfast cereals .


Control group followed website ( A ) giving standard advice on weight loss.Study site visits at 0 , 4 , 12 and 24 weeks for measurements of height , weight , skinfolds , body fat , waist and hip circumference .


180 subjects were randomly allocated to two equal groups.Subjects were in good health and aged 1950 years , with a BMI ranging from 2540 kg/m 2 .


At baseline there was no difference in mean age or BMI between the two groups .


The percentage change in body mass loss was greater when following website B than website A ( n = 90 ; ITT repeated measures p = 0.013 ) .


For completers ( website A : n = 62 , website B : n = 64 ) , the percentage change in body mass loss was also greater for website B than website A ( repeated measures p = 0.023 ) .


The advice and motivation offered by an interactive website , including provision and consumption of breakfast cereals , results in significantly greater loss of body mass compared to the use of a standard website .


It is not possible to discern which of the three factors is responsible .


This randomized , double-blind , placebo-controlled parallel-group study assessed the effects of sodium glucose cotransporter 2 inhibition by dapagliflozin on insulin sensitivity and secretion in subjects with type 2 diabetes mellitus ( T2DM ) , who had inadequate glycemic control with metformin ( with or without an insulin secretagogue ) .


Forty-four subjects were randomized to receive dapagliflozin 5 mg or matching placebo once daily for 12 weeks .


Subjects continued stable doses of background antidiabetes medication throughout the study .


Insulin sensitivity was assessed by measuring the glucose disappearance rate ( GDR ) during the last 40 min of a 5-h hyperinsulinemic , euglycemic clamp .


Insulin secretion was determined as the acute insulin response to glucose ( AIRg ) during the first 10 min of a frequently sampled intravenous glucose tolerance test .


Where noted , data were adjusted for baseline values and background antidiabetes medication .


An adjusted mean increase from baseline in GDR ( last observation carried forward ) , at Week 12 , was observed with dapagliflozin ( 7.98 % ) versus a decrease with placebo ( -9.99 % ) .


The 19.97 % ( 95 % confidence interval 5.75-36 .10 ) difference in GDR versus placebo was statistically significant ( P = 0.0059 ) .


A change from baseline in adjusted mean AIRg of 15.39 mU/L min was observed with dapagliflozin at Week 12 , versus -12.73 mU/L min with placebo ( P = 0.0598 ) .


Over 12 weeks , numerical reductions from baseline in glycosylated hemoglobin ( HbA1c ) , fasting plasma glucose , and body weight were observed with dapagliflozin ( -0.38 % , -0.39 mmol/L , and -1.58 % , respectively ) versus slight numerical increases with placebo ( 0.03 % , 0.26 mmol/L , and 0.62 % , respectively ) .


In patients with T2DM and inadequate glycemic control , dapagliflozin treatment improved insulin sensitivity in the setting of reductions in HbA1c and weight .


We examined the causes of hospitalization and death of people who inject drugs participating in the Bangkok Tenofovir Study , an HIV preexposure prophylaxis trial .


The Bangkok Tenofovir Study was a randomized , double-blind , placebo-controlled trial conducted during 2005 to 2012 among 2413 people who inject drugs .


We reviewed medical records to define the causes of hospitalization and death , examined participant characteristics and risk behaviors to determine predictors of death , and compared the participant mortality rate with the rate of the general population of Bangkok , Thailand .


Participants were followed an average of 4 years ; 107 died : 22 ( 20.6 % ) from overdose , 13 ( 12.2 % ) from traffic accidents , and 12 ( 11.2 % ) from sepsis .


In multivariable analysis , older age ( 40-59 years ; P = .001 ) , injecting drugs ( P = .03 ) , and injecting midazolam ( P < .001 ) were associated with death .


The standardized mortality ratio was 2.9 .


People who injected drugs were nearly 3 times as likely to die as were those in the general population of Bangkok and injecting midazolam was independently associated with death .


Drug overdose and traffic accidents were the most common causes of death , and their prevention should be public health priorities .


We aimed to explore the influence of a motivationally-enhanced instructional design on motivation to learn and knowledge , hypothesizing that outcomes would be higher for the enhanced instructional format .


Medicine residents completed four online learning modules on primary care topics .


Using a crossover design , learners were randomized to receive two standard and two motivationally-enhanced learning modules .


Both formats had self-assessment questions , but the enhanced format questions were framed to place learners in a supervisory/teaching role .


Learners received a baseline motivation questionnaire , a short motivation survey before and after each module , and a knowledge posttest .


One hundred twenty seven residents were randomized .


123 residents ( 97 % ) completed at least one knowledge posttest and 119 ( 94 % ) completed all four posttests .


Across all modules , a one-point increase in the pretest short motivation survey was associated with a 2.1-point increase in posttest knowledge .


The change in motivation was significantly higher for the motivationally enhanced format ( standard mean change -0.01 , enhanced mean change +0.09 , difference = 0.10 , CI 0.001 to 0.19 ; p = 0.048 ) .


Mean posttest knowledge score was similar ( standard mean 72.8 , enhanced mean 73.0 , difference = 0.2 , CI -1.9 to 2.1 ; p = 0.90 ) .


The motivationally enhanced instructional format improved motivation more than the standard format , but impact on knowledge scores was small and not statistically significant .


Learners with higher pre-intervention motivation scored better on post-intervention knowledge tests , suggesting that motivation may prove a viable target for future instructional enhancements .


To study the effects of a health check by a nurse alone or combined with an exercise intervention in middle-aged men at increased cardiovascular risk .


A randomized controlled trial .


Primary care in Kirkkonummi municipality with 36 000 inhabitants .


A health check by a nurse alone or combined with an exercise intervention to controls with no intervention was compared .


A total of 168 men aged 35 to 45 years with at least two cardiovascular risk factors and physical activity ( PA ) frequency < 3 times a week .


Metabolic syndrome ( MetS ) as defined by International Diabetes Federation/American Heart Association and self-reported PA frequency .


Overall , focusing on health increased physical activity frequency in middle-aged men .


After one year , 19 % had increased PA to 3 times a week ( 95 % CI 12-26 ) .


All study groups increased PA to 3 times : 26 % of men in the exercise intervention group , 15 % of men in the health check group , and 16 % of controls .


The differences between the groups were not statistically significant .


The intervention did not have any meaningful impact on MetS or other cardiovascular outcomes at one-year follow up .


Physical activity increased in all study groups of middle-aged men in this health-promotion trial .


The interventions had no effect on metabolic syndrome or other cardiovascular outcomes in the participants .


The trial increased awareness and collaboration in physical activity promotion among municipal health care and exercise services .


Vegetable consumption among preschool children is below recommended levels .


New evidence-based approaches to increase preschoolers ' vegetable intake , particularly in the child care setting , are needed .


This study tests the effectiveness of two community-based randomized interventions to increase vegetable consumption and willingness to try vegetables : ( 1 ) the pairing of a vegetable with a familiar , well-liked food and ( 2 ) enhancing the visual appeal of a vegetable .


Fifty-seven preschoolers enrolled in a Child and Adult Care Food Program-participating child care center participated in the study ; complete lunch and snack data were collected from 43 and 42 children , respectively .


A within-subjects , randomized design was used , with order of condition counterbalanced .


For lunch , steamed broccoli was served either on the side of or on top of cheese pizza .


For a snack , raw cucumber was served either as semicircles with chive and an olive garnish or arranged in a visually appealing manner ( in the shape of a caterpillar ) .


Paired t-tests were used to determine differences in consumption of meal components , and McNemar 's test was performed to compare willingness to taste .


Neither visual appeal enhancement nor pairing with a liked food increased vegetable consumption .


Pairing increased willingness to try the vegetable from 79 % to 95 % of children ( p = 0.07 ) .


Greater vegetable intake occurred at snack than at lunch .


Further research should explore the strategy of pairing vegetables with liked foods .


Greater consumption at snack underscores snack time as a critical opportunity for increasing preschool children 's vegetable intake .


To compare the difference in the clinical efficacy on cervical spondylosis of vertebral artery type ( CSA ) treated with thermosensitive moxibustion at different dosages .


Sixty cases of CSA were randomized into a saturated moxa dosage group and a regular moxa dosage group , 30 cases in each one .


The thermosensitive moxibustion was adopted in the two groups .


The mild suspended moxibustion was applied at two acupoints with the strongest thermosensitization .


In the saturated moxa dosage group , the moxibustion time was determined by the disappearance of thermosensitization .


In the regular moxa dosage group , 15 min was required on each acupoint .


The treatment was given twice a day for first 4 days in the two groups .


Since the 5th day , the treatment was given once a day , continuously for 10 times , and totally 14 days were required .


The score of symptoms and function and clinical efficacy were compared between the two groups before and after treatment as well as 6-month follow-up after treatment .


The curative and effective rate was 56.7 % ( 17/30 ) after treatment and 60.0 % ( 18/30 ) in 6-month follow-up after treatment in the saturated moxa dosage group , which were superior to 26.7 % ( 8/30 ) and 30.0 % ( 9/30 ) in the regular moxa dosage group respectively ( P < 0.01 , P < 0.05 ) .


The scores of clinical symptoms and function after treatment and in follow-up were improved apparently as compared with those before treatment in both groups ( all P < 0.01 ) .


The scores of clinical symptoms and function after treatment and in follow-up in the saturated moxa dosage group were increased much more apparently than those in the regular moxa dosage group ( after treatment : 22.32 + / - 4.64 vs 17.43 + / - 3.21 ; in follow-up : 23.01 + / - 4.76 vs 18.32 + / - 2.13 , both P < 0.01 ) .


The thermosensitization moxibustion of saturated dosage achieves the superior short-term and long-term efficacies in the treatment of CSA as compared with the regular moxibustion dosage .


To investigate changes in standard base excess ( SBE ) when administering two different infusion regimens for elective hip replacement within a goal-directed haemodynamic algorithm .


This prospective , double-blind , randomized , controlled study enrolled patients scheduled for primary hip replacement surgery , who were randomized to receive either an unbalanced crystalloid ( chloride : 155.5 mmol/l ) or a 1 : 1 mixture of a balanced crystalloid and a balanced colloid ( 6 % w/v hydroxyethyl starch 130/0 .42 ; chloride : 98 and 112 mmol/l , respectively ) .


Fluid management was goal-directed to optimize stroke volume using oesophageal Doppler .


A total of 40 patients ( 19 female/21 male ) participated in the study .


After surgery , median ( 25-75 % percentiles ) SBE was significantly lower in the unbalanced group compared with the balanced group : -2.0 mmol/l ( -3.1 to -1.1 ) versus -0.4 mmol/l ( -1.2 to 0.7 ) , respectively .


This difference was mainly due to greater plasma chloride concentrations in the unbalanced group .


The amount of study medication required to reach haemodynamic stability ( median 1200 ml ) did not differ between the two groups .


SBE decreased in the unbalanced group without influence on fluid requirements and haemodynamic stability .


Bacterial resistance development is one of the most urgent problems in healthcare worldwide .


In Europe , dentistry accounts for a comparatively high amount of antibiotic prescriptions .


In light of increasing levels of bacterial resistance , this development is alarming .


So far , very few interventional studies have been performed , and further research is urgently needed .


By means of a complex educational intervention , the DREAM trial aims at optimising antibiotic prescribing behaviour of general dentists in Germany .


This is a cluster-randomised controlled trial , where each cluster consists of one dental practice and all of its patients in a defined period .


Participants are general dentists practicing in the German region of Mecklenburg-Western Pomerania .


Randomisation takes place after baseline data collection ( 6months ) and will be stratified by the antibiotic prescribing rates of the participating dental practices .


Dentists randomised into the intervention group will participate in a complex small group educational seminar that aims at : increasing knowledge on bacterial resistance , pharmacology , and prophylaxis of infectious endocarditis ; increasing awareness of dentist-patient communication using video-taped vignettes of dentist-patient communication on antibiotic treatment ; improving collaboration between general dentists , general practitioners , and practice-based cardiologists on the necessity of antibiotic prophylaxis ; enhancing awareness of the dentists ' own prescribing habits by providing antibiotic prescribing feedback ; and increasing patient knowledge on antibiotic treatment by providing patient-centred information material on antibiotic prophylaxis of endocarditis .


The dentists randomised into the control group will not receive any educational programme and provide care as usual .


Primary outcome is the overall antibiotic prescribing rate measured at T1 ( period of six months after intervention ) .


In a subgroup of adult patients affected by odontogenic infections , microbiological analyses for antibiotic resistance of oral streptococci are performed .


Major aim of the study is to improve the process of decision making with regard to antibiotic prescribing .


The approach is simple to implement and might be used rapidly in graduate and post-graduate medical education .


We expect the results of this trial to have a major impact on antibiotic prescription strategies and practices in Germany .


Current Controlled Trials ISRCTN09576376 .


Renal impairment in cancer patients can affect treatment tolerability and outcomes .


This analysis evaluated the safety and efficacy of nab-paclitaxel ( nab-P ) versus solvent-based paclitaxel ( sb-P ) , both in combination with carboplatin ( C ) , in patients with advanced non-small-cell lung cancer ( NSCLC ) and renal impairment .


Untreated patients with stage IIIB/IV disease with NSCLC and a performance status of 0/1 were randomly assigned ( 1:1 ) to receive 100 mg/m ( 2 ) nab-P weekly plus C ( under the curve = 6 , every 3 weeks ) or 200 mg/m ( 2 ) sb-P plus C ( under the curve = 6 ) every 3 weeks .


The primary end point was overall response rate .


Of 1038 treated patients in the phase III trial , 38 % had mild renal impairment ( creatinine clearance > 50 to 80 mL/min ; n = 198 for nab-P/C and n = 206 for sb-P/C ) and 5 % had moderate renal impairment ( creatinine clearance 50 mL/min : n = 26 for nab-P/C and n = 27 for sb-P/C ) .


For nab-P/C versus sb-P/C , the treatment difference in efficacy in patients with either level of renal impairment was comparable to the overall population but did not reach statistical significance , with an overall response rate of 35 % versus 27 % ( response rate ratio , 1.324 ; P = .060 ) in patients with mild renal impairment , and 31 % versus 19 % ( response rate ratio , 1.662 ; P = .300 ) in patients with moderate renal impairment .


Overall survival and progression-free survival were nonsignificantly longer for nab-P/C versus sb-P/C in these subsets .


Patients with renal impairment experienced less grade 3 or higher neutropenia and sensory neuropathy , but more thrombocytopenia and anemia with nab-P/C versus sb-P/C .


nab-P/C proved beneficial and tolerable in patients with advanced NSCLC and mild and moderate renal impairment .


The effect of aspirin upon platelet function is well documented although experimental studies suggest that aspirin may also affect oxidative stress , vascular inflammation , endothelial dysfunction and dysglycaemia .


The optimal dose of aspirin for cardiovascular protection in type 2 diabetes is still debated .


We examined the effects of different doses of aspirin upon these novel markers of cardiovascular risk and any association between aspirin-mediated changes in these markers .


Subjects with type 2 diabetes attended for baseline evaluation including BMI , glycaemic and lipid markers , endothelial function ( photoplethysmography ) , insulin resistance ( HOMA ) , inflammation ( sVCAM-1 and Hs-CRP ) and markers of oxidative stress [ total anti-oxidant status ( TAOS and FRAP ) , whole blood total glutathione ( GSH ) assays ] .


Subjects then received in random , sequential , blinded fashion aspirin 75 mg day ( -1 ) , aspirin 300 mg day ( -1 ) , aspirin 3.6 g day ( -1 ) or placebo for 2 weeks with a 2-week washout .


The above investigations were repeated after each intervention .


Aspirin-related changes compared with placebo were analysed using repeated measures ANOVA .


Subjects = 17 ( M - 12 ; F - 5 ) , mean age - 57.4 9.1 years ( mean 1 SD ) , HbA1c - 63 13 mmol mol ( -1 ) ( 7.9 1.2 % ) , total cholesterol 4.57 1.01 mmol l ( -1 ) .


At baseline TAOS value was 59.3 9.7 M AEAC ( Ascorbate Equivalent Anti-oxidant Concentration ) , glutathione 302.2 183.3 mmol l ( -1 ) and FRAP 0.86 0.23 mM FeII .


None of the aspirin doses had a significant impact upon BMI , blood pressure , lipid parameters , insulin sensitivity ( HOMA ) , FRAP , TAOS , GSH , endothelial function , glycaemic control ( fructosamine ) or inflammation ( sVCAM-1 and HsCRP ) .


Aspirin exhibited no significant dose-dependent effect on markers of vascular inflammation , oxidative stress , insulin resistance and endothelial function ( photoplethysmography ) when used in type 2 diabetes over a 2-week period .


NCT00898950 , EUDRACT :2004 -001418 -14 ) .


Acetazolamide has been used to attenuate Hunter-Cheyne-Stokes breathing with central sleep apnea ( CSA ) associated with heart failure .


However , the mechanisms underlying this improvement remain to be fully elucidated .


We hypothesized that acetazolamide stabilizes CSA by attenuating the ventilatory sensitivity to CO2 , which is increased in patients with heart failure and is thought to be the major mechanism mediating CSA .


Six consecutive male patients with stable systolic heart failure and CSA ( apnea-hypopnea index [ AHI ] 15 episodes/h ) were randomized to a double-blind crossover protocol with acetazolamide or placebo received 1 hour before bedtime for six nights with 2 weeks of wash-out .


Under both conditions , we measured the hypercapnic ventilatory response ( HCVR ) , arterial blood Pco2 , steady-state metabolic CO2 production , overnight attended polysomnography , and also assessed cardiac and pulmonary function .


Compared with placebo , acetazolamide significantly decreased the AHI ( 65 32 vs. 31 19 events/h , mean SD ) .


Acetazolamide increased the HCVR slope by 55 % ( 3.3 1.7 vs. 5.1 2.4 L/min/mm Hg ; P = 0.03 ) , an increase that far exceeded the 12 % fall in arterial Pco2 ( P = 0.02 ) .


The acetazolamide-induced change in the balance of these effects ( HCVR Pco2 ) was inversely associated with the reduction in AHI ( r = 0.8 ; P = 0.045 ) .


This placebo-controlled study indicates that acetazolamide improves CSA in patients with heart failure despite an increase in the slope of the HCVR .


However , because the degree of HCVR elevation inhibits the improvement in unstable breathing , an increased CO2 chemosensitivity may be a key mechanism underlying an incomplete resolution of CSA with acetazolamide .


The Medicare Accountable Care Organization ( ACO ) programs encourage integration of providers into large groups and reward provider groups for improving quality , but not explicitly for reducing health care disparities .


Larger group size and better overall quality may or may not be associated with smaller disparities .


To examine differences in patient characteristics between provider groups sufficiently large to participate in ACO programs and smaller groups ; the association between group size and racial disparities in quality ; and the association between quality and disparities among larger groups .


Using 2009 Medicare claims for 3.1 million beneficiaries with cardiovascular disease or diabetes and linked data on provider groups , we compared racial differences in quality by provider group size , adjusting for patient characteristics .


Among larger groups , we used multilevel models to estimate correlations between group performance on quality measures for white beneficiaries and black-white disparities within groups .


Four process measures of quality , hospitalization for ambulatory care-sensitive conditions ( ACSCs ) related to cardiovascular disease or diabetes , and hospitalization for any ACSC .


Beneficiaries served by larger groups were more likely to be white and live in areas with less poverty and more education .


Larger group size was associated with smaller disparities in low-density lipoprotein ( LDL ) cholesterol testing and retinal exams , but not in other process measures or hospitalization for ACSCs .


Among larger groups , better quality for white beneficiaries in one measure ( hospitalization for ACSCs related to cardiovascular disease or diabetes ) was correlated with smaller racial disparities ( r = 0.28 ; P = 0.02 ) , but quality was not correlated with disparities in other measures .


Larger provider group size and better performance on quality measures were not consistently associated with smaller racial disparities in care for Medicare beneficiaries with cardiovascular disease or diabetes .


ACO incentives rewarding better quality for minority groups and payment arrangements supporting ACO development in disadvantaged communities may be required for ACOs to promote greater equity in care .


Our study aims to evaluate the image quality and feasibility of 128-slice dual-energy CTA ( DE-CTA ) for supra-aortic arteries using reduced amounts of contrast medium ( CM ) .


A prospective study was performed in 54 patients receiving CTA of the head and neck with a 128-slice dual-source CT system .


Patients were randomized into two groups with a volume of either 40 mL of CM ( Group I ) or 50 mL of CM ( Group II ) .


Arterial and venous enhancements were recorded for quantitative assessment .


Qualitative assessments for images without bone removal ( BR ) were based on a ) the visualization of the circle of Willis and b ) streak artifacts due to residual CM in the subclavian or internal jugular veins ipsilateral to injection of CM .


Qualitative assessment of dual-energy images using BR was based on the presence of bone remnants and vessel integrity .


Quantitative data was compared using the Student t test .


The ( 2 ) test was used for the qualitative measurements of streak artifacts in veins while the Mann-Whitney U test was used for the qualitative measurements of images with BR .


Arterial and venous attenuation was significantly higher in Group II ( P = 0.000 ) .


Image quality regarding the circle of Willis was excellent in both groups ( 3.900.30 for Group I and 4.000 for Group II ) .


Imaging of the internal jugular veins was scored higher in Group I ( 1.870.72 ) compared with Group II ( 1.480.51 ) ( P = 0.021 ) .


Within Group I using BR , mean scores for bone remnants did not differ significantly ( P > 0.05 ) but mean scores of vessel integrity ( P < 0.05 ) did .


Contrast-enhanced head and neck CTA is feasible using a scan protocol with low amounts of contrast medium ( 40 mL ) on a 128-slice dual-energy CTA .


The 40-mL protocol provides satisfactory image quality before and after dual-energy bone-removal post-processing .


To evaluate the late cardiotoxicity ( CT ) of high-dose chemotherapy ( CT ) according to the modified NHL-BFM-90 ( mNHL-BFM-90 ) protocol in adult patients with diffuse large B-cell lymphoma ( DLBCL ) .


The results of electrocardiography ( ECG ) and echocardiography ( echoCG ) were analyzed in 40 DLBCL patients treated according to the mNHL-BFM-90 program in the Hematology Research Center ( HRC ) , Russian Academy of Medical Sciences ( RAMS ) , in 2002 to 2009 .


A study group consisted of 20 men and 20 women whose age was 31 to 76 years ; median age was 56.5 years at the time of their examination and the median follow-up time after therapy was 6 years .


The individual cumulative dose of doxorubicin was 150-300 mg/M2 .


A comparison group included 19 patients receiving CHOP/R-CHOP CT in HRC , RAMS , in 2002 to 2009 .


Out of them , there were 8 men and 11 women whose age was 39 to 78 years median age was 70 years at the time of their examination .


The individual cumulative dose of doxorubicin was 200-400 mg/M2 .


ECG and echoCG were carried out before and 5 years or more after CT. .


Out of the 40 patients with DLBCL , the signs of subclinical cardiomyopathy ( CMP ) were detected in 24 ( 60 % ) patients ; no clinical manifestations of congestive heart failure ( CHF ) were found in any patient .


In the comparison group of 19 patients receiving CHOP/R-CHOP CT , 14 ( 74 % ) patients were found to have signs of subclinical CMP and no clinical signs of CHF .


The summary toxicity index significantly depended on age ( p = 0.03 ) and a history of heart disease ( p = 0.3 ) ; it was significantly higher after CHOP/R-CHOP CT ( p = 0.05 ) .


There was a statistically significant relationship of the risk of subclinical CMP to the history of heart diseases ( p = 0.05 ) .


Late cardiotoxicity of the mNHL-BFM-90 program does not exceed the toxicity of standard CHOP/R-CHOP therapy .


Post-CT Echo-CG and ECG findings showed that the patients with the most marked subclinical signs of CMP in both groups had cardiotoxicity risk factors , such as coronary heart disease , hypertensive disease , or diabetes in their history .


No clinically significant CHF was identified in any patient .


Patients with metastatic castration-resistant prostate cancer have few treatment options .


We investigated the safety and efficacy of lenalidomide , an immunomodulatory agent with anti-angiogenic properties , in combination with docetaxel and prednisone in chemotherapy-naive patients with metastatic castration-resistant prostate cancer .


In this randomised , double-blind , placebo-controlled , phase 3 study , we randomly assigned chemotherapy-naive patients with progressive metastatic castration-resistant prostate cancer in a 1:1 ratio to receive docetaxel ( 75 mg/m ( 2 ) ) on day 1 and prednisone ( 5 mg twice daily ) on days 1-21 and either lenalidomide ( 25 mg ) or placebo once daily on days 1-14 of each 21 day treatment cycle .


Permuted block randomisation was done with an interactive voice response system and stratified by Eastern Cooperative Oncology Group performance status , geographic region , and type of disease progression .


Clinicians , patients , and investigators were masked to treatment allocation .


The primary endpoint was overall survival .


Efficacy analysis was by intention to treat .


Patients who received at least one dose of study drug were included in the safety analyses .


This study is registered with ClinicalTrials.gov , number NCT00988208 .


1059 patients were enrolled and randomly assigned between Nov 11 , 2009 , and Nov 23 , 2011 ( 533 to the lenalidomide group and 526 to the control group ) , and 1046 patients received study treatment ( 525 in the lenalidomide group and 521 in the placebo group ) .


At data cutoff ( Jan 13 , 2012 ) after a median follow-up of 8 months ( IQR 5-12 ) , 221 patients had died : 129 in the lenalidomide group and 92 in the placebo group .


Median overall survival was 177 months ( 95 % CI 148-188 ) in the lenalidomide group and not reached in the placebo group ( hazard ratio [ HR ] 153 , 95 % CI 117-200 , p = 00017 ) .


The trial was subsequently closed early due to futility .


The number of deaths that occurred during treatment or less than 28 days since the last dose were similar in both groups ( 18 [ 3 % ] of 525 patients in the lenalidomide group vs 13 [ 2 % ] of 521 patients ) .


109 ( 21 % ) patients in the lenalidomide group and 78 ( 15 % ) in the placebo group died more than 28 days from last dose , mainly due to disease progression .


At least one grade 3 or higher adverse event was reported in 381 ( 73 % ) of 525 patients receiving lenalidomide and 303 ( 58 % ) of 521 patients receiving placebo .


Grade 3-4 neutropenia ( 114 [ 22 % ] for lenalidomide vs 85 [ 16 % ] for placebo ) , febrile neutropenia ( 62 [ 12 % ] vs 23 [ 4 % ] ) , diarrhoea ( 37 [ 7 % ] vs 12 [ 2 % ] ) , pneumonia ( 24 [ 5 % ] vs five [ 1 % ] ) , dyspnoea ( 22 [ 4 % ] vs nine [ 2 % ] ) , asthenia ( 27 [ 5 % ] vs 17 [ 3 % ] ) , and pulmonary embolism ( 32 [ 6 % ] vs seven [ 1 % ] ) occurred more frequently in the lenalidomide group than in the placebo group .


Overall survival with the combination of lenalidomide , docetaxel , and prednisone was significantly worse than with docetaxel and prednisone for chemotherapy-naive men with metastatic , castration-resistant prostate cancer .


Further research with this treatment combination is not warranted .


Celgene Corporation .