In this mechanistic randomized , double-blind , placebo-controlled , cross-over study of patients ( n = 20 ) receiving sustained-release and immediate-release opioid medication as part of their palliative care , we examine memory effects of an additional dose of participants ' immediate-release medication ( oxycodone or morphine ) or placebo .


Immediate prose recall and recall of related and unrelated word pairs was assessed pre-and post-drug ( placebo or immediate-release opioid ) .


Memory for these stimuli was also tested after a delay on each testing occasion .


Finally , performance on an ` interference ' word pair task was assessed on the two testing occasions since proactive interference has been posited as a mechanism for acute opioid-induced memory impairment .


Unlike previous work , we found no evidence of memory impairment for material presented before or after individually tailored , ` breakthrough ' doses of immediate-release opioid .


Furthermore , immediate-release opioid did not result in increased memory interference .


On the other hand , we found enhanced performance on the interference word pair task after immediate-release opioid , possibly indicating lower levels of interference .


These results suggest that carefully titrated immediate-release doses of opioid drugs may not cause extensive memory impairment as previously reported , and in fact , may improve memory in certain circumstances .


Importantly , our findings contrast strikingly with those of a study using the same robust design that showed significant memory impairment .


We propose that factors , such as depressive symptoms , education level and sustained-release opioid levels may influence whether impairment is observed following immediate-release opioid treatment .


Emergency abdominal surgery carries a considerable risk of death and postoperative complications .


Early detection and timely management of complications may reduce mortality .


The aim was to evaluate the effect and feasibility of intermediate care compared with standard ward care in patients who had emergency abdominal surgery .


This was a randomized clinical trial carried out in seven Danish hospitals .


Eligible for inclusion were patients with an Acute Physiology And Chronic Health Evaluation ( APACHE ) II score of at least 10 who were ready to be transferred to the surgical ward within 24h of emergency abdominal surgery .


Participants were randomized to either intermediate care or standard surgical ward care after surgery .


The primary outcome was 30-day mortality .


In total , 286 patients were included in the modified intention-to-treat analysis .


The trial was terminated after the interim analysis owing to slow recruitment and a lower than expected mortality rate .


Eleven ( 76 per cent ) of 144 patients assigned to intermediate care and 12 ( 85 per cent ) of 142 patients assigned to ward care died within 30 days of surgery ( odds ratio 091 , 95 per cent c.i. 038 to 216 ; P = 0828 ) .


Thirty ( 208 per cent ) of 144 patients assigned to intermediate care and 37 ( 261 per cent ) of 142 assigned to ward care died within the total observation period ( hazard ratio 078 , 95 per cent c.i. 048 to 126 ; P = 0310 ) .


Postoperative intermediate care had no statistically significant effect on 30-day mortality after emergency abdominal surgery , nor any effect on secondary outcomes .


The trial was stopped prematurely owing to slow recruitment and a much lower than expected mortality rate among the enrolled patients .


NCT01209663 ( http://www.clinicaltrials.gov ) .


To examine the effects of a group music therapy on psychiatric symptoms and depression for patient with schizophrenia in a psychiatric nursing home .


Eighty patients with schizophrenia were randomly assigned to a music intervention group ( MIG ) or usual care group ( UCG ) .


Both groups received similar medical and routine care .


The MIG received a 60-min group music therapy twice a week , a total of ten sessions .


The UAG only received the usual care with no music therapy .


Psychiatric symptoms and depression assessments were conducted using the positive and negative syndrome scale and the depression scale for schizophrenia at baseline , the posttest , and at a 3-month follow-up .


Thirty-eight patients in the MIG and 42 in the UCG completed the study .


After 10 sessions of group music therapy , the groups showed statistically significant differences in psychiatric symptoms ( p < .05 ) and depression status ( p < .05 ) .


Group music therapy is an economical and easily implemented method of improving depression and psychiatric symptoms in patients with schizophrenia .


The Stroke Oxygen Study ( SOS ) is a multi-center randomized controlled trial of oxygen supplementation in patients with acute stroke .


The main hypothesis for the trial is that fixed-dose oxygen treatment during the first 3 days after an acute stroke improves outcome .


The secondary hypothesis is that restricting oxygen supplementation to night time only is more effective than continuous supplementation .


This paper describes the statistical analysis plan for the study .


Patients ( n = 8000 ) are randomized to three groups : ( 1 ) continuous oxygen supplementation for 72 hours ; ( 2 ) nocturnal oxygen supplementation for three nights ; and ( 3 ) no routine oxygen supplementation .


Outcomes are recorded at 7 days , 90 days , 6 months , and 12 months .


The primary outcome measure is the modified Rankin scale at 90 days .


Data will be analyzed according to the intention-to-treat principle .


Methods of statistical analysis are described , including the handling of missing data , the covariates used in adjusted analyses , planned subgroups analyses , and planned sensitivity analyses .


This trial is registered with the ISRCTN register , number ISRCTN52416964 ( 30 September 2005 ) .


There has been no nationwide epidemiological investigation of allergic rhinitis ( AR ) that was diagnosed by both questionnaires and laboratory tests in Korea .


This study investigated the prevalence , risk factors , and comorbidities of AR in South Korea .


The Korean National Health and Nutritional Examination Survey examined a representative sample of the Korean population .


A total of 2305 participants underwent immunoradiometric assay for specific IgE antibodies against common indoor allergens .


Healthy , atopy only , and AR groups were defined according to the results of allergen test .


The weighted prevalence for each group was calculated .


Risk factors including food and comorbidities were identified using univariate or multivariate analyses .


The patients were also categorized into four subgroups according to the Allergic Rhinitis and Its Impact on Asthma ( ARIA ) classification and associated comorbidities were analyzed .


The prevalence of atopy only and AR was 30.0 1.2 % and 16.2 1.0 % , respectively .


The multivariate analysis showed that the prevalence was influenced by sex ( p < 0.01 ) for atopy only and sex ( p = 0.09 ) , age ( p = 0.02 ) , marital status ( p = 0.24 ) , and stress level ( p = 0.30 ) for AR .


Compared with the healthy group , asthma ( odds ratio [ OR ] = 4.77 ) , nasal polyp ( NP ; OR = 3.44 ) , chronic rhinosinusitis ( OR = 13.93 ) , and olfactory dysfunction ( OR = 4.88 ) were more prevalent in the AR group .


Based on the ARIA guideline , intermittent mild rhinitis was most common ( 58.1 % ) .


Asthma was correlated to severity and atopic dermatitis and NPs was associated with persistency .


Daily intake of less mackerel and more carrots , bread , and bean curd were associated with the increased risk of AR .


Prevalence , risk factors , and comorbidities of AR were evaluated in the general Korean population , which will contribute to prevention and treatment of AR and its comorbidities in Koreans .


Exercise training is recommended for non-cystic fibrosis ( CF ) bronchiectasis , but the long-term effects are unclear .


This randomised controlled trial aimed to determine the effects of exercise training and review of airway clearance therapy ( ACT ) on exercise capacity , health related quality of life ( HRQOL ) and the incidence of acute exacerbations in people with non-CF bronchiectasis .


Participants were randomly allocated to 8weeks of supervised exercise training and review of ACT , or control .


Primary outcomes of exercise capacity and HRQOL ( Chronic respiratory disease questionnaire ) and secondary outcomes of cough-related QOL ( Leicester cough questionnaire ) and psychological symptoms ( Hospital anxiety and depression scale ) were measured at baseline , following completion of the intervention period and at 6 and 12months follow up .


Secondary outcomes of the exacerbation rate and time to first exacerbation were analysed over 12months .


Eighty-five participants ( mean FEV1 74 % predicted ; median Modified Medical Research Council Dyspnoea grade of 1 ( IQR [ 1-3 ] ) were included .


Exercise training increased the incremental shuttle walk distance ( mean difference to control 62m , 95 % CI 24 to 101m ) and the 6-minute walking distance ( mean difference to control 41m , 95 % CI 19 to 63m ) , but these improvements were not sustained at 6 or 12months .


Exercise training reduced dyspnoea ( p = 0.009 ) and fatigue ( p = 0.01 ) but did not impact on cough-related QOL or mood .


Exercise training reduced the frequency of acute exacerbations ( median 1 [ IQR 1-3 ] ) compared to the control group ( 2 [ 1-3 ] ) over 12months follow up ( p = 0.012 ) , with a longer time to first exacerbation with exercise training of 8months ( 95 % CI 7 to 9months ) compared to the control group ( 6months [ 95 % CI 5 to 7months ] , p = 0.047 ) .


Exercise training in bronchiectasis is associated with short term improvement in exercise capacity , dyspnoea and fatigue and fewer exacerbations over 12months .


ClinicalTrials.gov ( NCT00885521 ) .


Failure to return to pregnancy weight by 6 months postpartum is associated with long-term obesity , as well as adverse health outcomes .


This research evaluated a postpartum weight management programme for women with a body mass index ( BMI ) > 25 kg m ( -2 ) that combined behaviour change principles and a low-intensity delivery format with postpartum nutrition information .


Women were randomised at 24-28 weeks to control ( supported care ; SC ) or intervention ( enhanced care ; EC ) groups , stratified by BMI cohort .


At 36 weeks of gestation , SC women received a ` nutrition for breastfeeding ' resource and EC women received a nutrition assessment and goal-setting session about post-natal nutrition , plus a 6-month correspondence intervention requiring return of self-monitoring sheets .


Weight change , anthropometry , diet , physical activity , breastfeeding , fasting glucose and insulin measures were assessed at 6 weeks and 6 months postpartum .


Seventy-seven percent ( 40 EC and 41 SC ) of the 105 women approached were recruited ; 36 EC and 35 SC women received a programme and 66.7 % and 48.6 % completed the study , respectively .


No significant differences were observed between any outcomes .


Median [ interquartile range ( IQR ) ] weight change was EC : -1.1 ( 9.5 ) kg versus SC : -1.1 ( 7.5 ) kg ( 6 weeks to 6 months ) and EC : +1.0 ( 8.7 ) kg versus SC : +2.3 ( 9 ) kg ( prepregnancy to 6 months ) .


Intervention women breastfed for half a month longer than control women ( 180 versus 164 days ; P = 0.10 ) .


An average of 2.3 out of six activity sheets per participant was returned .


Despite low intervention engagement , the high retention rate suggests this remains an area of interest to women .


Future strategies must facilitate women 's engagement , be individually tailored , and include features that support behaviour change to decrease women 's risk of chronic health issues .


The aim of the present study was to compare two novel fine structure strategies `` FS4 '' and `` FS4-p '' with the established fine structure processing ( FSP ) strategy .


FS4 provides fine structure information on the apical four-electrode channels .


With FS4-p , these electrodes may be stimulated in a parallel manner .


The authors evaluated speech perception , sound quality , and subjective preference .


A longitudinal crossover study was done on postlingually deafened adults ( N = 33 ) who were using FSP as their default strategy .


Each participant was fitted with FS4 , FS4-p , and FSP , for 4 months in a randomized and blinded order .


After each run , an Adaptive Sentence test in noise ( Oldenburger Sentence Test [ OLSA ] ) and a Monosyllable test in quiet ( Freiburger Monosyllables ) were performed , and subjective sound quality was determined with a Visual Analogue Scale .


At the end of the study the preferred strategy was noted .


Scores of the OLSA did not reveal any significant differences among the three strategies , but the Freiburger test showed a statistically significant effect ( p = 0.03 ) with slightly worse scores for FS4 ( 49.7 % ) compared with FSP ( 54.3 % ) .


Performance of FS4-p ( 51.8 % ) was comparable with the other strategies .


Both audiometric tests depicted a high variability among subjects .


The number of best-performing strategies for each participant individually was as follows : ( a ) for the OLSA : FSP , N = 10.5 ; FS4 , N = 10.5 ; and FS4-p , N = 12 ; and ( b ) for the Freiburger test : FSP , N = 14 ; FS4 , N = 9 ; and FS4-p , N = 10 .


A moderate agreement was found in the best-performing strategies of the Speech tests within the participants .


For sound quality , speech in quiet , classical , and pop music were assessed .


No significant effects of strategy were found for speech in quiet and classical music , but auditory impression of pop music was rated as more natural in FSP compared with FS4 ( p = 0.04 ) .


It is interesting that at the end of the study , a majority of the participants favored the new coding strategies over their previous default FSP ( FSP , N = 13 ; FS4 , N = 13 ; FS4-p , N = 7 ) .


In summary , FS4 and FS4-p offer new and further options in audio processor fitting , with similar levels of speech understanding in noise as FSP .


This is an interesting result , given that the strategies ' presentation of temporal fine structure differs from FSP .


At the end of the study , 20 of 33 subjects chose either FS4 or FS4-p over their previous default strategy FSP .


While alcohol intoxication is known to increase disinhibited behavior , the degree to which disinhibition occurs appears to depend on a number of factors including executive functioning ability .


However , the neural mechanisms by which individual differences in executive functioning lead to variable degrees of disinhibition remain unclear .


The aim of the current study was to examine the neural mechanisms by which individual differences in working memory ( WM ) capacity moderate alcohol-induced disinhibition .


Seventeen heavy-drinking males participated in a within-subjects design in which two sessions were completed : an alcohol session ( .82 g/kg ) and a control session .


Participants completed a go/no-go task while undergoing functional magnetic resonance imaging ( fMRI ) after ingestion of the control or alcohol beverage .


WM capacity was measured using an operation span task .


Significant interactions of session and WM capacity emerged in contrasts examining successful response inhibition within superior temporal gyrus and unsuccessful inhibition in regions within the default mode network .


In all cases , individuals with low WM capacity demonstrated a relative decrease in blood oxygen level-dependent ( BOLD ) response during the alcohol compared to control session , whereas the high-WM-capacity group demonstrated relative increases in BOLD response in the alcohol compared to control session .


Low WM capacity appears to be associated with decreased neural response to signals indicating a need for behavioral control , an effect that may lead to increased difficulty with inhibiting responses and increased negative consequences from alcohol intoxication .


Individuals with substance use disorders ( SUDs ) experience increased smoking-related morbidity and mortality but severely compromised smoking treatment benefits .


Residential SUD treatment settings may be particularly positioned to target smoking , with ever-increasing smoking bans and culture shifts , but most smokers continue smoking .


This study examined the effects of contingency management ( CM ) for increasing smoking abstinence in residential patients .


Smokers interested in quitting were recruited from a residential SUD program for men and were randomized to frequent smoking monitoring with behavioral support ( monitoring ; n = 21 ) or that plus smoking abstinence-contingent ( expired carbon monoxide [ CO ] 6 ppm ; urinary cotinine 30ng/ml ) incentives ( CM , n = 24 ) for 4 weeks .


After setting a quit date , procedures included daily behavioral support and smoking self-reports , 2 CO samples ( a.m. / p.m. ) Monday through Friday , and cotinine tests on Mondays .


CM participants received escalating draws for prizes ( $ 1 , $ 20 , and $ 100 values ) for negative tests ; positive and missed samples reset draws .


Follow-ups involved samples , self-reported smoking , and self-efficacy ( weeks 4 , 8 , 12 , and 24 ) .


Percent days CO-negative was higher with CM ( median [ interquartile range ] 51.7 % [ 62.8 % ] ) compared to monitoring ( 0 % [ 32.1 % ] ) ( p = .002 ) .


Cigarettes per day declined and point-prevalence abstinence increased through follow-up ( p < .01 ) , without significant group by time effects ( p > .05 ) .


Abstinence self-efficacy increased overall during the intervention and more with CM compared to monitoring and was associated with abstinence across conditions through follow-up .


CM improved some measures of response to smoking treatment in residential SUD patients .


To observe the efficacy of Jianbu Tongluo Xunzheng Liquid ( JTXL ) in treating knee osteoarthritis ( KOA ) , and to explore the correlation between changes of infrapatellar fat pad scanned by CT and the efficacy .


Totally 105 KOA outpatients were randomly assigned to three groups , i.e. , the treatment group , the control group , and the combination group , 35 in each group .


Patients in the treatment group were fumigated by JTXL , 30 min each time , once daily , 10 times as a course of treatment , 3 courses in total .


Those in the control group received intra-articular injection of Sodium Hyaluronate Injection ( SHI ) , 3 mL each time , once per 6 days , 5 times in total .


Those in the combination group were treated by fumigation of JTXL + intra-articular injection of SHI in the same way as the aforesaid two groups .


All patients were treated for 30 days .


Their clinical efficacy and changes of infrapatellar fat pad scanned by CT were observed , and their correlation was analyzed .


The total effective rate was 88.57 % in the combination group , better than that of the control group ( 74.29 % ) and the treatment group ( 80.00 % ; both P < 0.05 ) .


Besides , the score for knee joint functions at Hospital for Special Surgery ( HSS ) was better in the combination group than the other two groups ( P < 0.05 ) .


The anteroposterior diameter , exterior-interior diameter , the superior-inferior diameter were shortened , and the density decreased in the treatment group and the combination group ( P < 0.05 ) .


Besides , they were superior to those of the control group ( P < 0.05 ) .


Changes of infrapatellar fat pad scanned by CT only existed in the combination group and the treatment group , indicating changes of CT scanning was only correlated with effect on changing physicochemical properties of infrapatellar fat pad .


Treatment by Chinese medicine could omnipotently and balanced regulate functions and structures of every tissue .


Therefore , CT could be taken as a better method for clinical efficacy observation by Chinese medicine .


To evaluate therapeutic efficacy upon augmenting the initial communication to patients regarding the diagnosis of psychogenic nonepileptic seizures ( PNES ) with a novel , brief group psychoeducation administered by the same team that provided the video-electroencephalography ( VEEG ) confirmed diagnosis and within 4 weeks of the diagnosis .


Prior to discharge from the epilepsy monitoring unit ( EMU ) , a standardized communication strategy was utilized to explain the diagnosis of PNES to all patients prior to enrollment .


Enrolled patients were then randomized to either participation in three successive and monthly group psychoeducational sessions ( intervention group ) , or routine seizure clinic follow-up visits ( control group ) .


Both groups completed questionnaires at time of enrollment , and then at approximately 3 months ( follow-up 1 ) and 6 months ( follow-up 2 ) after discharge , assessing for : ( 1 ) primary outcomes that include a measure of psychosocial functioning , as well as interval difference in seizure frequency/intensity ; and ( 2 ) secondary outcomes that include interval seizure-related emergency room visits or hospitalizations , development of new and medically unexplained symptoms , and results of an internal measure of knowledge and perception outcomes .


The majority ( 73 % ) of patients from the intervention group commenced on therapy sessions within 4 weeks after learning of the diagnosis .


Although we did not observe significant group difference in seizure frequency/intensity , patients from the intervention group showed significant improvement on the Work and Social Adjustment Scale ( WSAS ) scores at both follow-up 1 ( p = 0.013 ) and follow-up 2 ( p = 0.038 ) after discharge from the EMU .


In addition , we observed a trend toward lesser likelihood for seizure-related emergency room visits or hospitalizations for the intervention group ( p = 0.184 ) , as well as meaningful insights from an internal measure of intervention outcomes .


These findings suggest that our cost/resource effective , brief group psychoeducational program , when administered early and by the same team who confirmed and communicated the diagnosis of PNES , may contribute to significant functional improvement among participating patients .


Few studies have considered the retention of the individuals ( alters ) comprising the social networks of people in recovery .


The purpose of this study was to describe factors predicting whether alters were retained 6 months after participants completed treatment .


The Important Person Inventory was given to 270 ex-offenders ( 224 men , 46 women ) transitioning from treatment to Oxford House residences , Safe Haven therapeutic communities , or to usual aftercare .


A 6-month follow-up was completed by 176 participants ( 137 men , 39 women ) .


We found that alters who were related to the participant , did not use drugs , were embedded in smaller networks , and had more frequent contact with the participant were significantly more likely to be retained as important people over 6 months .


The alters ' drinking and criminal history were not significantly predictive of retention in the network .


Certain characteristics of important people are related to their retention in a social network .


Understanding these relationships and the extent to which the network change that occurs is aligned with abstinence-supporting networks is essential for creating effective social interventions for persons in recovery .


A clinical randomized controlled trial .


This study sought to compare the clinical effectiveness of CT-guided nucleoplasty , CT-guided nucleoplasty combined with nerve root injection , and CT-guided transforaminal lumbar epidural injections in treating patients with contained lumbar disk herniation and leg pain , which are caused by radicular encroachment .


Lumbar disk herniation is the most common cause of nerve root pain .


The conservative treatment is proved to be effective for the majority of these patients , and the remaining patients are not ideal surgical candidates .


Studies have found that minimally invasive percutaneous disk procedures may be preferable to open surgery in certain clinical situations .


However , nucleoplasty in treating contained lumbar disk herniation and leg pain caused by radicular encroachment is still a controversy .


A total of 97 patients with leg pain and MRI evidence of small-sized or medium-sized herniated disks correlating with the symptoms participated in the study .


The patients were randomly allocated into 3 groups : the CT-guided nucleoplasty group ( N = 33 ) , the CT-guided nucleoplasty with nerve root injection group ( N = 35 ) , and CT-guided transforaminal lumbar epidural injections group ( N = 29 ) .


Numeric Rating Scale ( NRS ) pain score and Oswestry Disability Index ( ODI ) values were applied at pretreatment and 1 week , 1 month , 3 months , and 12 months at posttreatment .


There were statistically significant decreases ( P = 0.000 ) in the NRS and ODI scores for all posttreatment time points when compared with the pretreatment values in all the 3 groups .


The average NRS and ODI results for the transforaminal lumbar epidural injections group were significantly higher than those for the other 2 groups at 3 and 12 months posttreatment ( P < 0.05 ) .


The combination of nucleoplasty with nerve root injection produced a significantly greater reduction in the NRS and ODI scores when compared with nucleoplasty at 1 week ( P = 0.000 for NRS and P = 0.004 for ODI ) and 1 month ( P = 0.000 for NRS and P = 0.007 for ODI ) after the treatment .


The results of this study suggest that CT-guided nucleoplasty with radiofrequency energy is a relative effective and safe technique for treating leg pain caused by radicular encroachment .


Furthermore , nucleoplasty combined with nerve root injection had achieved a significant greater improvement in pain management and functional level in short term ( within 1 mo ) after treatment than nucleoplasty alone .


Endovascular or intra-arterial treatment ( IAT ) increases the likelihood of recanalization in patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion .


However , a beneficial effect of IAT on functional recovery in patients with acute ischemic stroke remains unproven .


The aim of this study is to assess the effect of IAT on functional outcome in patients with acute ischemic stroke .


Additionally , we aim to assess the safety of IAT , and the effect on recanalization of different mechanical treatment modalities .


A multicenter randomized clinical trial with blinded outcome assessment .


The active comparison is IAT versus no IAT .


IAT may consist of intra-arterial thrombolysis with alteplase or urokinase , mechanical treatment or both .


Mechanical treatment refers to retraction , aspiration , sonolysis , or use of a retrievable stent ( stent-retriever ) .


Patients with a relevant intracranial proximal arterial occlusion of the anterior circulation , who can be treated within 6hours after stroke onset , are eligible .


Treatment effect will be estimated with ordinal logistic regression ( shift analysis ) ; 500 patients will be included in the trial for a power of 80 % to detect a shift leading to a decrease in dependency in 10 % of treated patients .


The primary outcome is the score on the modified Rankin scale at 90days .


Secondary outcomes are the National Institutes of Health stroke scale score at 24hours , vessel patency at 24hours , infarct size on day 5 , and the occurrence of major bleeding during the first 5days .


If IAT leads to a 10 % absolute reduction in poor outcome after stroke , careful implementation of the intervention could save approximately 1 % of all new stroke cases from death or disability annually .


NTR1804 ( 7 May 2009 ) / ISRCTN10888758 ( 24 July 2012 ) .


Listening to music is a low-cost intervention that has demonstrated ability to reduce pain and anxiety levels in various medical procedures .


Subjects undergoing electrophysiological examinations were randomized into a music-listening group and a control group .


Visual analog scales were used to measure anxiety and pain levels during the procedure .


Thirty subjects were randomized to each group .


No statistically significant difference was found in anxiety or pain levels during the procedure between groups .


However , most subjects in the music-listening group reported anxiety and pain reduction and would prefer to hear music in a future examination .


Although listening to music during electrophysiological examinations did not reduce anxiety or pain significantly , most subjects felt a positive effect and would prefer to hear music ; therefore , we suggest that music may be offered optionally in the electromyography laboratory setting .


The incidence and prognostic impact of late bleeding complications after transcatheter aortic valve replacement ( TAVR ) are unknown .


The aim of this study was to identify the incidence , predictors , and prognostic impact of major late bleeding complications ( MLBCs ) ( 30 days ) after TAVR .


Clinical and echocardiographic outcomes of patients who underwent TAVR within the randomized cohorts and continued access registries in the PARTNER ( Placement of Aortic Transcatheter Valves ) trial were analyzed after stratifying by the occurrence of MLBCs .


Predictors of MLBCs and their association with 30-day to 1-year mortality were assessed .


Among 2,401 patients who underwent TAVR and survived to 30 days , MLBCs occurred in 142 ( 5.9 % ) at a median time of 132 days ( interquartile range : 71 to 230 days ) after the index procedure .


Gastrointestinal complications ( n = 58 [ 40.8 % ] ) , neurological complications ( n = 22 [ 15.5 % ] ) , and traumatic falls ( n = 11 [ 7.8 % ] ) were identified as the most frequent types of MLBCs .


Independent predictors of MLBCs were the presence of low hemoglobin at baseline , atrial fibrillation or flutter at baseline or 30 days , the presence of moderate or severe paravalvular leak at 30 days , and greater left ventricular mass at 30 days .


MLBCs were identified as a strong independent predictor of mortality between 30 days and 1 year ( adjusted hazard ratio : 3.91 ; 95 % confidence interval : 2.67 to 5.71 ; p < 0.001 ) .


MLBCs after TAVR were frequent and associated with increased mortality .


Better individualized and risk-adjusted antithrombotic therapy after TAVR is urgently needed in this high-risk population .


( THE PARTNER TRIAL : Placement of AoRTic TraNscathetER Valve Trial ; NCT00530894 ) .


Phonemic verbal fluency ( PVF ) is a cognitive function that involves serial processes termed clustering and switching and which is impacted in both normal aging and dementia .


The cognitive reserve hypothesis suggests that appropriate cognitive stimulation could maintain or improve cognitive performance .


This study examines the effect on PVF performance of a brief crossword-based intervention in a cognitively normal , community-based sample .


Thirty-seven members of active retirement groups volunteered to participate and were randomly assigned to a crossword group and a control group .


The former attempted a crossword daily for 4weeks while the latter kept a daily gratitude diary for the same period .


22 mixed analyses of variance revealed that the crossword group performed significantly better over time than the control group in both total PVF score and in the cluster size component .


Daily crosswords may be a simple and effective means of bolstering PVF performance in older people .


Metabolic syndrome and depression seem to share some common underlying mechanisms , although less is known about the impact of metabolic syndrome dietary treatments on depression .


This study examined the association between a hypocaloric treatment designed to reduce metabolic syndrome features in self-perceived depression and the potential involvement of dietary components and oxidative stress changes .


Analyses were based on volunteers ( n = 55 ) with metabolic syndrome ( age 50 1 y.o. ; 38M/17F ) , where depressive symptoms were assessed using the Beck Depression Inventory .


Participants followed two hypocaloric diets ( control diet and RESMENA diet ) with the same energy restriction ( -30 % TCV ) for six months .


Depressive symptoms , dietary records , anthropometrical measurements , biochemical parameters and oxidative stress levels were analysed .


Both diets improved self-perceived depression similarly ( p = 0.528 ) .


Participants with lower depressive symptoms at baseline reported a significantly higher intake of omega-3 polyunsaturated fatty acids ( p trend = 0.002 ) .


Interestingly , after adjusting for potential confounders , the increase in folate consumption ( p = 0.011 ) and the decrease in plasma malondialdehyde levels ( p = 0.012 ) throughout the intervention , were associated with the improvement in depressive symptoms .


A higher intake of folate and a decline in malondialdehyde plasma levels during a weight loss intervention , were related to improvements in manifestations of depression ( www.clinicaltrials.gov ; NCT01087086 ) .


To investigate the effect of somatostatin and dexamethasone on early postoperative small bowel obstruction with obliterative peritonitis ( EPSBO-OP ) .


This prospective randomized study included 70 patients diagnosed with EPSBO-OP from June 2002 to January 2009 .


Patients were randomized into two groups : a control group received total parenteral nutrition and nasogastric ( NG ) tube feeding ; and an intervention group received , in addition , somatostatin and dexamethasone treatment .


The primary endpoints were time to resolution of bowel obstruction and length of hospital stay , and the secondary endpoints were daily NG output and NG feeding duration , treatment-related complications , postoperative obstruction relapse , and patient satisfaction .


Thirty-six patients were allocated to the intervention group and 34 to the control group .


No patient needed to undergo surgery .


Patients in the intervention group had an earlier resolution of bowel obstruction ( 22.4 9.1 vs 29.9 10.1 d , P = 0.002 ) .


Lower daily NG output ( 583 208 vs 922 399 mL/d , P < 0.001 ) , shorter duration of NG tube use ( 16.7 8.8 vs 27.7 9.9 d , P < 0.001 ) , and shorter length of hospital stay ( 25.8 vs 34.9 d , P = 0.001 ) were observed in the intervention group .


The rate of treatment-related complications ( P = 0.770 ) and relapse of obstruction ( P = 0.357 ) were comparable between the two groups .


There were no significant differences in postoperative satisfaction at 1 , 2 and 3 years between the two groups .


Somatostatin and dexamethasone for EPSBO-OP promote resolution of obstruction and shorten hospital stay , and are safe for symptom control without increasing obstruction relapse .


Despite the health risks , physical inactivity is common .


Identifying the correlates of physical activity to inform the design of interventions to reduce the disease burden associated with physical inactivity is a public health imperative .


Rural adults have a unique set of characteristics influencing their activity behaviour , and are typically understudied , especially in England .


The aim of this study was to identify the personal , social , and environmental correlates of physical activity in adults living in rural villages .


The study used baseline data from 2415 adults ( response rate : 37.7 % ) participating in the first time period of a stepped-wedge cluster randomised trial , conducted in 128 rural villages from south-west England .


Data collected included demographic characteristics , social factors , perception of the local environment , village level factors ( percentage male , mean age , population density , Index of Multiple Deprivation , and sport market segmentation ) , and physical activity behaviour .


Random effects ( `` multilevel '' ) logistic regression models were fitted to the binary outcome whether individuals met physical activity guidelines , and random effects linear regression models were fitted to the continuous outcome MET-minutes per week leisure time physical activity , using the personal , social , environmental , and village-level factors as predictors .


The following factors both increased the odds of meeting the recommended activity guidelines and were associated with more leisure-time physical activity : being male ( p = 0.002 ) , in good health ( p < 0.001 ) , greater commitment to being more active ( p = 0.002 ) , favourable activity social norms ( p = 0.004 ) , greater physical activity habit ( p < 0.001 ) , and recent use of recreational facilities ( p = 0.01 ) .


In addition , there was evidence ( p < 0.05 ) that younger age , lower body mass index , having a physical occupation , dog ownership , inconvenience of public transport , and using recreational facilities outside the local village were associated with greater reported leisure-time physical activity .


None of the village-level factors were associated with physical activity .


This study adds to the current literature on the correlates of physical activity behaviour by focusing on a population exposed to unique environmental conditions .


It highlights potentially important correlates of physical activity that could be the focus of interventions targeting rural populations , and demonstrates the need to examine rural adults separately from their urban counterparts .


Living in a prediabetes state significantly increases a patient 's risk for both diabetes and cardiovascular disease .


Tianqi capsule , containing 10 Chinese herbal medicines , is used in China for the treatment of type 2 diabetes mellitus ( T2DM ) .


The purpose of this study was to assess whether Tianqi prevented T2DM in subjects with impaired glucose tolerance ( IGT ) over the course of a 12-month treatment .


Individuals with IGT were randomly allocated in a double-blind manner to receive Tianqi ( n = 210 ) or a placebo ( n = 210 ) for 12 months .


Oral glucose tolerance tests were conducted every 3 months to assess the development of diabetes or restoration to normal glucose tolerance .


All subjects received the same lifestyle education .


The primary endpoint was the conversion of IGT to T2DM .


Body weight and body mass index were observed .


Adverse effects were monitored .


Of the 420 enrolled subjects with IGT , 389 completed the trial ( 198 in the Tianqi group and 191 in the placebo group ) .


At the end of the 12-month trial , 36 subjects in the Tianqi group ( 18.18 % ) and 56 in the placebo group ( 29.32 % ) had developed diabetes ( P = .01 ) .


There was a significant difference in the number of subjects who had normal glucose tolerance at the end of the study between the Tianqi and placebo groups ( n = 125 , 63.13 % , and n = 89 , 46.60 % , respectively ; P = .001 ) .


Cox 's proportional hazards model analysis showed that Tianqi reduced the risk of diabetes by 32.1 % compared with the placebo .


No severe adverse events occurred in the trial .


There were no statistical differences in body weight and body mass index changes between the Tianqi group and the placebo group during the 12-month trial .


Treatment with a Tianqi capsule for 12 months significantly decreased the incidence of T2DM in subjects with IGT , and this herbal drug was safe to use .


Orthostatic hypotension commonly accompanies supine hypertension , and is associated with low 25-hydroxyvitamin D levels .


We tested whether high-dose intermittent oral vitamin D therapy could ameliorate orthostatic hypotension in older patients with isolated systolic hypertension .


We conducted a subgroup analysis of data from a parallel-group , double-blind , randomized , placebo-controlled trial .


Patients aged over 70 years with supine office SBP above 140mmHg and DBP below 90mmHg received 100000 units oral vitamin D3 or matching placebo every 3 months for 1 year .


Office supine and standing blood pressure were measured at baseline , and 3 , 6 , 9 and 12 months , along with arterial stiffness and flow-mediated dilatation of the brachial artery .


Of 159 patients randomized to the main trial , 75 patients with orthostatic hypotension at baseline were included in this analysis .


The mean age was 78 ( SD 5 ) years , baseline blood pressure was 162/76mmHg and the mean baseline orthostatic fall in blood pressure on standing was 32/5mmHg .


After adjustment for baseline age , 25-hydroxyvitamin D , SBP and orthostatic fall , the fall in SBP was less in the vitamin D group at 3 months [ treatment effect 6mmHg , 95 % confidence interval ( CI ) 0 to 12 ] , but repeated-measures analysis showed no significant treatment effect ( 3mmHg for systolic fall , 95 % CI -1 to 8 ; 1mmHg for diastolic fall , 95 % CI -1 to 3 ) .


Twelve months of intermittent , high-dose oral vitamin D3 did not significantly improve orthostatic hypotension in older patients with isolated systolic hypertension .


Early prediction of the expected benefit of treatment in recurrent ovarian cancer ( ROC ) patients may help in drug development decisions .


The actual value of 50 % CA-125 decrease is being reconsidered .


The main objective of the present study was to quantify the links between longitudinal assessments of CA-125 kinetics and progression-free survival ( PFS ) in treated recurrent ovarian cancer ( ROC ) patients .


The CALYPSO randomized phase III trial database comparing two platinum-based regimens in ROC patients was randomly split into a `` learning dataset '' and a `` validation dataset '' .


A parametric survival model was developed to associate longitudinal modeled CA-125 changes ( CA125 ) , predictive factors , and PFS .


The predictive performance of the model was evaluated with simulations .


The PFS of 534 ROC patients were properly characterized by a parametric mathematical model .


The modeled CA125 from baseline to week 6 was a better predictor of PFS than the modeled fractional change in tumor size .


Simulations confirmed the model 's predictive performance .


We present the first parametric survival model quantifying the relationship between PFS and longitudinal CA-125 kinetics in treated ROC patients .


The model enabled calculation of the increase in CA125 required to observe a predetermined benefit in PFS to compare therapeutic strategies in populations .


Therefore , CA125 may be a predictive marker of the expected gain in PFS and an early predictive tool in drug development decisions .


Drug-eluting balloons ( DEB ) may reduce infrapopliteal restenosis and reintervention rates versus percutaneous transluminal angioplasty ( PTA ) and improve wound healing/limb preservation .


The goal of this clinical trial was to assess the efficacy and safety of IN.PACT Amphirion drug-eluting balloons ( IA-DEB ) compared to PTA for infrapopliteal arterial revascularization in patients with critical limb ischemia ( CLI ) .


Within a prospective , multicenter , randomized , controlled trial with independent clinical event adjudication and angiographic and wound core laboratories 358 CLI patients were randomized 2:1 to IA-DEB or PTA .


The 2 coprimary efficacy endpoints through 12 months were clinically driven target lesion revascularization ( CD-TLR ) and late lumen loss ( LLL ) .


The primary safety endpoint through 6 months was a composite of all-cause mortality , major amputation , and CD-TLR .


Clinical characteristics were similar between the 2 groups .


Significant baseline differences between the IA-DEB and PTA arms included mean lesion length ( 10.2 cm vs. 12.9 cm ; p = 0.002 ) , impaired inflow ( 40.7 % vs. 28.8 % ; p = 0.035 ) , and previous target limb revascularization ( 32.2 % vs. 21.8 % ; p = 0.047 ) .


Primary efficacy results of IA-DEB versus PTA were CD-TLR of 9.2 % versus 13.1 % ( p = 0.291 ) and LLL of 0.61 0.78 mm versus 0.62 0.78 mm ( p = 0.950 ) .


Primary safety endpoints were 17.7 % versus 15.8 % ( p = 0.021 ) and met the noninferiority hypothesis .


A safety signal driven by major amputations through 12 months was observed in the IA-DEB arm versus the PTA arm ( 8.8 % vs. 3.6 % ; p = 0.080 ) .


In patients with CLI , IA-DEB had comparable efficacy to PTA .


While primary safety was met , there was a trend towards an increased major amputation rate through 12 months compared to PTA .


( Study of IN.PACT Amphirion Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia [ INPACT-DEEP ] ; NCT00941733 ) .


We tested the efficacy of a minimal intervention to create smoke-free homes in low-income households recruited through the United Way of Greater Atlanta 2-1-1 , an information and referral system that connects callers to local social services .


We conducted a randomized controlled trial ( n = 498 ) from June 2012 through June 2013 , with follow-up at 3 and 6 months .


The intervention consisted of 3 mailings and 1 coaching call .


Participants were mostly smokers ( 79.7 % ) , women ( 82.7 % ) , African American ( 83.3 % ) , and not employed ( 76.5 % ) , with an annual household income of $ 10,000 or less ( 55.6 % ) .


At 6-months postbaseline , significantly more intervention participants reported a full ban on smoking in the home than did control participants ( 40.0 % vs 25.4 % ; P = .002 ) .


The intervention worked for smokers and nonsmokers , as well as those with or without children .


Minimal intervention was effective in promoting smoke-free homes in low income households and offers a potentially scalable model for protecting children and adult nonsmokers from secondhand smoke exposure in their homes .


This clinical trial evaluated the influence of denture adhesive ( DA ) use on masticatory function in denture wearers according to their denture-bearing ridge status .


Thirty edentulous subjects , wearing new well-fitting dentures , were classified as having either a normal or resorbed ridge .


Mastication was evaluated in patients who completed chewing tests with and without two DA substances ( cream or strips ) , which were randomly assigned .


A chewing test with a sieve method analyzed masticatory performance .


A kinesiographic device evaluated chewing cycle , and a visual analog scale measured masticatory ability .


Data were submitted to Mauchly 's sphericity test , and PROC MIXED procedures were conducted on repeated measures .


Tukey-Kramer tests performed appropriate statistical comparisons ( P .05 ) .


DA use increased masticatory performance and ability in patients with both ridge types ( P < .05 ) .


Subjects with resorbed ridges showed the best masticatory performance ( P < .001 ) and lowest chewing cycle time ( P < .001 ) with DA cream , followed by DA strips and the nonadhesive trial .


For normal ridge subjects , decreases in 50 values were only significant with DA use ( P < .05 ) , regardless of DA type .


The denture-bearing ridge status alone did not alter masticatory function in any of the parameters evaluated .


DAs improve mastication by shortening the chewing cycle and by enhancing chewing ability and performance .


We aimed to investigate the effect of 21 % and 40 % oxygen supplementation on maternal and neonatal oxidative stress in elective cesarean section ( CS ) under spinal anesthesia .


Eighty term parturients undergoing elective CS under spinal anesthesia were enrolled in the study .


We allocated patients randomly to breathe 21 % ( air group ) or 40 % ( oxygen group ) oxygen from the time of skin incision until the end of the operation .


We collected maternal pre - and post-operative and umbilical artery ( UA ) blood samples .


Total antioxidant capacity ( TAC ) , total oxidant status ( TOS ) and the oxidative stress index ( OSI ) were measured .


Age , weight , height , parity , gestation week , spinal-skin incision time , skin incision-delivery time , delivery time , operation time , 1st and 5th minutes Apgar scores , and birth weight were similar between the groups ( p > 0.05 for all comparisons ) .


There were no differences in preoperative TAC , TOS , or OSI levels between the groups ( p > 0.05 for all comparisons ) .


Postoperative maternal TAC , TOS and OSI levels significantly increased in the oxygen group ( p = 0.047 , < 0.001 and 0.038 , respectively ) ; umbilical artery TAC levels significantly increased in the oxygen group ( p = 0.003 ) ; and umbilical artery TOS and OSI levels significantly increased in the air group ( p = 0.02 and < 0.001 , respectively ) .


The difference in impact on maternal and fetal oxidative stress of supplemental 40 % compared to 21 % oxygen mandates further large-scale studies that investigate the role of oxygen supplementation during elective CS under spinal anesthesia .


It is important to distinguish children with different levels of severity of obstructive sleep apnea syndrome ( OSAS ) preoperatively using clinical parameters .


This can identify children who most need polysomnography ( PSG ) prior to adenotonsillectomy ( AT ) .


To assess whether a combination of factors , including demographics , physical examination findings , and caregiver reports from questionnaires , can predict different levels of OSAS severity in children .


Baseline data from 453 children from the Childhood Adenotonsillectomy ( CHAT ) study were analyzed .


Children 5.0 to 9.9 years of age with PSG-diagnosed OSAS , who were considered candidates for AT , were included .


Polysomnography for diagnosis of OSAS .


Linear or logistic regression models were fitted to identify which demographic , clinical , and caregiver reports were significantly associated with the apnea hypopnea index ( AHI ) and oxygen desaturation index ( ODI ) .


Race ( African American ) , obesity ( body mass index z score > 2 ) , and the Pediatric Sleep Questionnaire ( PSQ ) total score were associated with higher levels of AHI and ODI ( P = .05 ) .


A multivariable model that included the most significant variables explained less than 3 % of the variance in OSAS severity as measured by PSG outcomes .


Tonsillar size and Friedman palate position were not associated with increased AHI or ODI .


Models that tested for potential effect modification by race or obesity showed no evidence of interactions with any clinical measure , AHI , or ODI ( P > .20 for all comparisons ) .


This study of more than 450 children with OSAS identifies a number of clinical parameters that are associated with OSAS severity .


However , information on demographics , physical findings , and questionnaire responses does not robustly discriminate different levels of OSAS severity .


clinicaltrials.gov Identifier : NCT00560859 .


In a phase III , open-label , comparative , noninferiority study , 638 subjects receiving de novo kidney transplants were randomized to one of three treatment arms : tacrolimus extended-release ( Astagraf XL ) qd , tacrolimus ( Prograf ) bid , or cyclosporine ( CsA ) bid .


All subjects received basiliximab induction , mycophenolate mofetil , and corticosteroids .


Safety and efficacy follow-up data through 4 years are reported .


Evaluations included patient and graft survival , study drug discontinuations , laboratory values including renal function and development of new-onset diabetes after transplantation , concomitant medications , and adverse events .


At study termination , 129 Astagraf XL , 113 Prograf , and 79 CsA patients had continued follow-up .


Demographic and baseline characteristics were similar in all arms .


Four-year Kaplan-Meier estimates of patient survival in the Astagraf XL , Prograf , and CsA groups were 93.2 , 91.2 , and 91.7 % , respectively , while graft survival was 84.7 , 82.7 , and 83.9 % , respectively .


At least one serious adverse event was reported in the majority of patients in each group during the study ( 65.9 % Astagraf XL , 69.8 % Prograf , and 65.6 % CsA ) .


Renal function was not significantly different between Astagraf XL and Prograf .


HgbA1c levels were collected every 6 months ; the 4-year Kaplan-Meier estimate for incidence of HgbA1c levels 6.5 % was significantly higher for both tacrolimus formulations compared to CsA ; 41.1 % ( Astagraf XL ) , 33.6 % ( Prograf ) , and 21.3 % ( CsA ) .


In this 4-year follow-up report , patients receiving Astagraf XL and Prograf showed comparable efficacy and safety profiles , with a higher incidence of new-onset diabetes after transplantation but superior renal function compared to patients receiving CsA .


The objective was to identify whether it was possible to change driver behavior by economic incentives and thereby reduce crash risk .


Furthermore , the objective was to evaluate the participants ' attitudes toward the pay-as-you-speed ( PAYS ) concept .


A one-year PAYS trial with economic incentives for keeping speed limits using intelligent speed assistance ( ISA ) was conducted in Sweden during 2011-2012 .


The full incentive was a 30 percent discount off the insurance premium .


The participants were private insurance customers and were randomized into a test group ( initial n = 152 , final n = 128 ) and a control group ( initial n = 98 , final n = 68 ) .


When driving , the drivers in the test group were informed and warned visually when the speed limit was exceeded .


They could also follow their driving results on a personal website .


The control group was not given any feedback at all .


To reflect the impact of the PAYS concept the proportion of distance driven above the speed limit was compared between the 2 groups .


The introduction of a PAYS concept shows that the test group significantly reduced the proportion of distance driven above the speed limit .


The proportion of driving at a speed exceeding 5 km/h over the speed limit was 6 percent for the test group and 14 percent for the control group .


It also showed that the effect was higher the higher the violation of speed .


The result remained constant over time .


It was shown that a PAYS concept is an effective way to reduce speed violations .


Hence , it has the possibility to reduce crash severity and thereby to save lives .


This could be an important step toward a safer road transport system .


The majority of the participants were in favor of the concept , which indicates the potential of a new insurance product in the future .


This study aimed to evaluate the effects of vitamin D intake on COPD exacerbation and FEV1 in the patients with severe and very severe COPD .


This double blind placebo control randomized clinical trial study was done in the Ashayer university hospital in Khorramabad in 2012 .


Eighty eight patients with severe and very severe COPD were randomly selected from those who recoursed to the internal medicine clinic of Ashayer hospital .


They were randomly allocated to case and placebo group .


The patients received routine treatment for COPD .


Along with the routine treatment , placebo group received 100,000 IU of oral vitamin D per month , for 6 months .


Data was analyzed using SPSS computer software , paired t-test , independent t-test , non parametric t-test and Pearson correlation coefficients .


In each group , there were 44 patients .


After the intervention , there were significant differences in FEV1 and the number of COPD exacerbation between the case and control group patients .


Also , after the study , in the case group , FEV1 was increased and the number of COPD exacerbation was decreased significantly .


Vitamin D intake decreased COPD exacerbation and improved FEV1 in the patients with severe and very severe COPD .


It is suggested that baseline serum vitamin D levels will recorded in similar studies and the effect of vitamin D intake will evaluated regarding the baseline serum vitamin D levels .


Our research utilized two popular theoretical conceptualizations of implicit self-esteem : 1 ) implicit self-esteem as a global automatic reaction to the self ; and 2 ) implicit self-esteem as a context/domain specific construct .


Under this framework , we present an extensive search for implicit self-esteem measure validity among different cultural groups ( Study 1 ) and under several experimental manipulations ( Study 2 ) .


In Study 1 , Euro-Canadians ( N = 107 ) , Asian-Canadians ( N = 187 ) , and Japanese ( N = 112 ) completed a battery of implicit self-esteem , explicit self-esteem , and criterion measures .


Included implicit self-esteem measures were either popular or provided methodological improvements upon older methods .


Criterion measures were sampled from previous research on implicit self-esteem and included self-report and independent ratings .


In Study 2 , Americans ( N = 582 ) completed a shorter battery of these same types of measures under either a control condition , an explicit prime meant to activate the self-concept in a particular context , or prime meant to activate self-competence related implicit attitudes .


Across both studies , explicit self-esteem measures far outperformed implicit self-esteem measures in all cultural groups and under all experimental manipulations .


Implicit self-esteem measures are not valid for individual or cross-cultural comparisons .


We speculate that individuals may not form implicit associations with the self as an attitudinal object .


To find a threshold body weight ( BW ) below 100 kg above which computed tomography pulmonary angiography ( CTPA ) using reduced radiation and a reduced contrast material ( CM ) dose provides significantly impaired quality and diagnostic confidence compared with standard-dose CTPA .


In this prospectively randomised study of 501 patients with suspected pulmonary embolism and BW < 100 kg , 246 were allocated into the low-dose group ( 80 kVp , 75 ml CM ) and 255 into the normal-dose group ( 100 kVp , 100 ml CM ) .


Contrast-to-noise ratio ( CNR ) in the pulmonary trunk was calculated .


Two blinded chest radiologists independently evaluated subjective image quality and diagnostic confidence .


Data were compared between the normal-dose and low-dose groups in five BW subgroups .


Vessel attenuation did not differ between the normal-dose and low-dose groups within each BW subgroup ( P = 1.0 ) .


The CNR was higher with the normal-dose compared with the low-dose protocol ( P < 0.006 ) in all BW subgroups except for the 90-99 kg subgroup ( P = 0.812 ) .


Subjective image quality and diagnostic confidence did not differ between CT protocols in all subgroups ( P between 0.960 and 1.0 ) .


Subjective image quality and diagnostic confidence with 80 kVp CTPA is not different from normal-dose protocol in any BW group up to 100 kg .


80 kVp CTPA is safe in patients weighing < 100 kg Reduced radiation and iodine dose still provide high vessel attenuation Image quality and diagnostic confidence with low-dose CTPA is good Diagnostic confidence does not deteriorate in obese patients weighing < 100 kg .


To investigate the efficacy of a two-week programme of repetitive exercise with cueing and movement strategies upon freezing of gait in people with Parkinson 's disease .


Randomized cross-over trial .


Specialist clinic for Parkinson 's disease .


A total of 22 patients with Parkinson 's disease and freezing while other symptoms had favorably responded to dopaminergic treatment .


Patients were randomized into a four-week cross-over trial , and received either treatment ( Group 1 ) or no treatment ( Group 2 ) during Period 1 , and switched during Period 2 .


Treatment consisted of a two-week programme during which the patients exercised cueing , and movement strategies together with a physiotherapist .


The primary outcome measure was a freezing score assessed from blinded and random ratings of video recordings .


The secondary outcome measure was a patient-reported freezing questionnaire .


Mean differences between the treatment periods ( treatment arms ) were evaluated for treatment ( period ) effects .


Sums of treatment periods were evaluated for carry-over effects .


The programme led to a significant treatment effect in the freezing score of 3.0 improvement ( 95 % confidence interval 0.9-5 .0 ; p < 0.01 ) .


No carry-over or period effects were detected .


The questionnaire revealed a period effect , so groups were compared after Period 1 , where a significant difference was found ( 15.0 vs. 11.7 ; p < 0.05 ) .


The two-week physiotherapy programme reduced the severity of freezing in patients with Parkinson 's disease .


Internet-delivered interventions have proven efficacious in changing people 's behaviours and related determinants , but the actual use of these interventions by the target group is often very low .


This article investigates whether arousing interest and enjoyment results in increased intervention use in an online context .


Invitations to visit a website about Hepatitis A , B and C virus infections ( Studies 1 and 3 ) and the website itself ( Studies 2 and 3 ) were manipulated to arouse interest and enjoyment .


Intention to visit the website ( Study 1 ) , clicking on the link to visit the website ( Studies 2 and 3 ) and the number of pages visited on the website ( Study 3 ) .


Arousing interest through an invitation resulted in a higher intention to visit the website ( Study 1 ) and a higher likelihood of clicking on the link to visit the website in comparison with arousing enjoyment ( Study 2 ) .


The number of pages visited increased when interest was aroused on the website itself ( Study 3 ) .


Arousing interest is a promising strategy to increase use of Internet-delivered interventions and potentially increase the public health impact of these interventions .


Pharmacokinetic changes have been found in critically ill patients , including ventilator-associated pneumonia ( VAP ) when compared with healthy volunteers leading to fluctuation of plasma concentrations .


To compare the probability of target attainment ( PTA ) and cumulative fraction of response ( CFR ) for meropenem between administration by a bolus injection and a 3-hour infusion .


The study was a randomized three-way crossover in nine patients with VAP .


Each patient received meropenem in three regimens consecutively : ( i ) a bolus injection of 1 g every eight hours ( q8h ) for 24 hours ; ( ii ) a 3-hour infusion of 1 g q8h for 24 hours ; and ( iii ) a 3-hour infusion of 2 g q8h for 24 hours .


The pharmacodynamic analysis of meropenem was performed to determine the PTA by using the Monte Carlo simulation and the study used susceptibility patterns obtained from EUCAST and MYSTIC for assessment of CFR .


For an MIC of 4 microg/ml , the PTAs achieving 40 % T > MIC following a bolus injection of 1 g q8h , a 3-hour infusion of 1 g q8h , and a 3-hour infusion of 2 g q8h were 87.71 % , 98.80 % , and 99.90 % , respectively .


Only the 3-hour infusion regimens were predicted to achieve a CFR > or = 90 % against E. coli , Klebsiella spp. , P. aeruginosa , and Acinetobacter spp .


A 3-hour infusion of 2 g of meropenem regimen was predicted to have the highest PTA rates .


Only the prolonged infusion regimens achieved a high CFR against E. coli , Klebsiella spp. , P. aeruginosa , and Acinetobacter spp .


Eccentric training has been popularized for physical conditioning and prevention/rehabilitation of musculoskeletal disorders , especially due to the expressive responses in terms of muscular strength gain .


In view of evidence that low-level laser therapy ( LLLT ) is able to increase exercise performance and accelerate post-exercise recovery , the aim of this study was to verify the effect of LLLT on hypertrophy and strengthening of knee extensor muscles submitted to eccentric training .


Thirty healthy male subjects were randomized into three groups : Control Group ( CG ) , Training Group ( TG ) and Training + LLLT Group ( TLG ) .


CG received no intervention , while TG and TLG were engaged on an 8-week knee extensor isokinetic eccentric training program .


Only subjects from TLG were treated with LLLT ( wavelength = 810 nm ; power output = 200 mW ; total dosage = 240 J ) before each training session .


Knee extensor muscle thickness and peak torque were assessed through ultrasonography and isokinetic dynamometry , respectively .


CG presented no changes in any variable throughout the study , while eccentric training led to significant increases in muscle thickness and peak torque in TG and TLG .


Subjects from TLG reached significantly higher percent changes compared to subjects from TG for sum of muscles ' thicknesses ( 15.4 vs. 9.4 % ) , isometric peak torque ( 20.5 vs. 13.7 % ) , and eccentric peak torque ( 32.2 vs. 20.0 % ) .


LLLT applied before eccentric training sessions seems to improve the hypertrophic response and muscular strength gain in healthy subjects .


The Chuanhu anti-gout mixture has been used for many years in the treatment of gout in Chinese Traditional Medicine , and current methods for treatments for acute gouty arthritis have been either less effective or have had serious side effects .


In this 12-week , double-blind , double-dummy , non-inferiority study , outpatient individuals with newly diagnosed acute gouty arthritis were randomly assigned to receive Chuanhu anti-gout mixture or colchicine .


Both the study investigators and the participants were masked to the treatment assignments .


The primary outcome was the recurrence rate of acute gouty arthritis , and the secondary outcomes were changes in white blood cells ( WHC ) and C-reactive protein ( CRP ) .


This trial is registered at ISRCTN.org as trial ISRCTN65219941 .


A total of 176 patients were randomly assigned to receive either the Chuanhu anti-gout mixture or Colchicine .


The overall recurrence rates in the Chuanhu anti-gout mixture group ( CH group ) and the Colchicine group ( Col group ) were 12.50 % vs 14.77 % ( difference -2.22 % , 95 % confidence interval ( 95 % CI ) : -10.78 % ~ 6.23 % ) , meeting the predefined non-inferiority criterion of 15 % , as did the data for WHC and CRP .


The incidence of adverse events ( mainly diarrhea ) was less in the Col group than in the CH group ( 2.27 % vs 28.41 % , 95 % CI 0.01 ~ 0.26 ) .


In addition , changes in blood uric acid , alanine aminotransferase , aspartate aminotransferase and creatinine in the CH group were significantly larger compared to those in the Col group ( P < 0.05 ) .


The Chuanhu anti-gout mixture was non-inferior to colchicine for the treatment of acute gouty arthritis .


The study suggested that the Chuanhu anti-gout mixture can be considered an alternative choice for the treatment of acute gouty arthritis because of its lower incidence of adverse events and its protection of kidney and renal function .


Atherosclerotic peripheral artery disease ( PAD ) is common and results in limitations in quality of life and potential progression to limb loss .


Options for therapy include medical therapy , supervised exercise , surgical revascularization , and , more recently , endovascular therapies to restore arterial perfusion to the limb .


Endovascular revascularization has evolved over the past 2 decades , from percutaneous transluminal angioplasty ( PTA ) to self-expanding stents , atherectomy , laser angioplasty , and drug-eluting stents .


Despite impressive technologic advances , PTA remains the standard of care at many institutions and is the recommended primary treatment modality for femoral-popliteal PAD according to current American College of Cardiology Foundation/American Heart Association guidelines .


However , restenosis after PTA is common .


Therefore , a significant clinical need remains for a device that is able to achieve more durable patency than PTA but does not require a permanent implant .


Drug-coated balloons ( DCBs ) have the potential to address this need .


Several randomized controlled clinical trials of PTA balloons coated with different formulations of paclitaxel have been conducted in Europe ( N Engl J Med 2008 ; 358:689 -699 ) ( Circulation 2008 ; 118:1358 -1365 ) ( Circ Cardiovasc Interv 2012 ; 5:831 -840 ) ( JACC Cardiovas Interv 2014 ; 7:10 -19 ) and demonstrated more durable efficacy than PTA with comparable safety .


These studies were limited by small sample sizes and powered solely for an angiographic primary end point .


The pivotal LEVANT 2 trial was designed in collaboration with the US Food and Drug Administration to demonstrate safety and efficacy in a large population and to obtain US Food and Drug Administration approval .


A prospective , multicenter , single-blind trial comparing the Lutonix DCB ( Bard Lutonix ; New Hope , MN ) versus PTA for treatment of femoropopliteal PAD ( LEVANT 2 ) is the first US-based 2:1 randomized controlled trial of 476 patients with femoral-popliteal PAD designed to demonstrate superior efficacy and noninferior safety of a novel paclitaxel DCB compared with PTA .


The primary efficacy end point is primary patency at 12 months .


The primary safety end point is composite freedom at 12 months from perioperative death , index limb amputation , reintervention , and limb-related mortality .


A series of important secondary end points include physical functioning , quality of life , revascularizations , and alternative measures of patency .


To minimize bias potential for confounding variables , LEVANT 2 ( 1 ) excluded patients stented after predilation before randomization , ( 2 ) incorporated very stringent criteria for bailout stenting , ( 3 ) did not count bailout stenting as a target lesion revascularization or failure of any end point , ( 4 ) required a blinded clinician to perform clinical evaluations at follow-up , and ( 5 ) required clinical assessment before review of duplex ultrasound results .


LEVANT 2 represents the first US-inclusive multicenter , randomized controlled trial to assess the safety and efficacy of a novel DCB compared with PTA as primary therapy for symptomatic PAD on the background of standard medical therapy .


To evaluate the efficacy of endoscopy with a transparent cap on biopsy positioning in Barrett 's esophagus ( BE ) .


One hundred and sixty-eight patients with suspected BE at endoscopy were enrolled in our study from November 2007 to December 2009 and divided into two groups : transparent cap group ( n = 60 ) and control group ( n = 108 ) .


Endoscopy with or without a transparent cap and subsequent biopsy of suspected lesions were performed by five experienced endoscopists in our hospital .


In both groups , two biopsy specimens were taken from each patient , and the columnar epithelium or goblet cells in histological assessment were used as the diagnostic standard for BE .


In the transparent cap group , 41 cases were tongue type , while 17 and two cases were identified as island type and circumferential type , respectively .


In the control group , 65 tongue-type cases were confirmed , with 38 island-type and five circumferential-type cases .


Moreover , there was no significant difference with regard to the composition of endoscopic BE types in the two groups ( P > 0.05 ) .


In the biopsy specimens , BE was detected in 50 cases in the transparent cap group ( 83.3 % , 50/60 ) , whereas the detection rate in the control group ( 69.4 % , 75/108 ) was lower compared to that in the transparent cap group ( P < 0.05 ) .


In addition , goblet cells were recognized in only eight cases ( all with columnar epithelium ) ( 8/60 , 13.3 % ) in the transparent cap group , with 11 cases in the control group .


Transparent cap-fitted endoscopy can guide biopsy positioning in BE without other accompanying complications , thus increasing the detection rate of BE .


To determine the efficacy and safety of a single-incision mini-sling compared with a transobturator midurethral sling for stress urinary incontinence ( SUI ) treatment .


This prospective single-center randomized controlled trial involved 130 women with a diagnosis of SUI .


Primary outcomes were the objective and subjective cure rates , defined as negative cough stress and pad tests , and satisfaction rates .


Quality of life assessed by the Incontinence Quality of Life Questionnaire and the Urogenital Distress Inventory Short Form , operation time , complications , and reoperation rates were also recorded .


The efficacy was analyzed using a noninferiority test with a margin of 15 % .


For the noninferiority test , a P value > .05 rejects the noninferiority hypothesis of the mini-sling .


Sixty-four patients in the mini-sling group and 56 in the transobturator group completed the 12-month follow-up .


The objective cure rates for the mini-sling and the transobturator sling were 68.1 % and 81.9 % ( absolute difference 13.8 ; 90 % confidence interval [ CI ] 1.5-26 .1 ; P = .439 ) and the subjective cure rates were 81.1 % and 88.5 % ( absolute difference 7.4 % ; 90 % CI 2.8-17 .6 ; P = .110 ) , respectively .


There was a significant improvement in quality of life in both groups .


Thigh pain was greater after the transobturator sling , four patients ( 7.1 % ) compared with zero ( P = .045 ) .


The mean operation time was 5 minutes shorter for the mini-sling procedure ( P = .000 ) .


Five patients ( 7.8 % ) in the mini-sling group and one patient ( 1.8 % ) in the transobturator group underwent surgical reintervention for persistent SUI ( P = .213 ) .


The noninferiority of the mini-sling could not be demonstrated in this study at the 12-month follow-up .


The mini-sling was associated with shorter operative time and less postoperative thigh pain .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT01094353 .


Various cytochrome P450 isoforms modulate sibutramine activity and influence sibutramine plasma levels and pharmacokinetics .


However , there are no available data to demonstrate the association of these polymorphisms with the clinical outcomes of sibutramine administration .


This study was a sub-investigation of a 12-week , double-blind , placebo-controlled trial examining the additive effect of orlistat on sibutramine .


The final analysis was restricted to 101 women who had fulfilled the protocol .


We evaluated the effects of genetic polymorphisms of CYP3A5 , CYP2C19 and CYP2B6 on the % weight loss and the occurrence of adverse events .


The change of pulse rate from baseline value was affected by both CYP2B6 and CYP3A5 genetic polymorphisms ( P < .01 for CYP3A5 and P = .01 for CYP2B6 ) .


Both CYP2B6 and CYP3A5 showed gene-gene interactions ( P < .01 ) .


After adjusting for significant variables in the backward stepwise regression model , the change of pulse rate and time-dependent weight reduction were significant only among the CYP2B6 genotypes ( P = .027 and P < .01 , respectively ) .


The CYP2B6 * 6 allele influences the extent of weight reduction and pulse rate changes in patients undergoing sibutramine treatment .


Enterotoxigenic Escherichia coli ( ETEC ) is a major cause of travellers ' diarrhoea .


We investigated the efficacy and safety of a skin-patch vaccine containing the pathogen 's heat-labile toxin ( LT ) in a population of travellers to Mexico and Guatemala .


In this phase 3 , randomised , double-blind , placebo-controlled field trial , healthy adults ( aged 18-64 years ) travelling from Germany or the UK to Mexico or Guatemala were assigned in a 1:1 ratio by a dynamic electronic randomisation system to receive transcutaneous immunisation with a patch containing 37.5 g of ETEC LT or a placebo patch .


Participants , site staff , and the investigators who did the analyses were masked to group assignment .


Participants were vaccinated before travel , with two patches given 14 days apart .


In the destination country , participants tracked stool output in a diary and provided stool samples for pathogen identification if diarrhoea occurred .


The primary endpoint was the proportion of participants with at least one episode of moderate-to-severe diarrhoea ( defined as four or more unformed stools in a 24 h period ) in which either or both ETEC enterotoxins ( LT and heat-stable toxin [ ST ] ) were detected .


The study is registered at ClinicalTrials.gov , number NCT00993681 .


2036 participants were recruited and randomly assigned between Oct 14 , 2009 , and Aug 13 , 2010 , with 1016 allocated to receive the LT patch and 1020 the placebo patch .


821 participants in the LT-patch group and 823 in the placebo group received both vaccinations and were analysed in the per-protocol population .


30 ( 3.7 % , 95 % CI 2.5-5 .2 ) participants in the LT-patch group and 46 ( 5.6 % , 4.1-7 .4 ) in the placebo group had moderate or severe ETEC diarrhoea ( vaccine efficacy 34.6 % , -2.2 to 58.9 ; p = 0.0621 ) .


9333 local ( ie , patch-site ) adverse events ( including erythema , rash , pruritus , hyperpigmentation , pain , hypopigmentation , and oedema ) occurred in 943 ( 93 % ) of 1015 participants in the LT-patch group , compared with 1444 local adverse events in 574 ( 56 % ) of 1019 participants in the placebo group ( p < 0.0001 ) .


Serious adverse events occurred in 25 participants ( 14 in the LT-patch group and 11 in the placebo group ) , with all regarded as either unrelated or possibly related to treatment .


Vaccine-induced hyperpigmentation persisted for at least 180 days after vaccination in 150 ( 18 % ) of the 849 participants who received both vaccinations and returned for final assessment in the LT-patch group , compared with none of the 842 participants in the placebo group .


The vaccine was immunogenic , with a post-vaccination geometric mean titre of LT-specific serum immunoglobulin G of 3400.29 , compared with 315.41 in the placebo group .


Although the LT antigen was delivered effectively by the skin patch , the vaccine did not protect travellers against diarrhoea caused by ETEC or other organisms .


Future vaccines against travellers ' diarrhoea might need to include several antigens against various diarrhoeal pathogens , and might need to be able to generate mucosal and higher systemic immunity .


There are several methods for postoperative analgesia for knee surgery .


The commonly utilized method is multimodal analgesia based on continuous femoral nerve block .


The aim of this study was to investigate the application of continuous adductor canal block for analgesia after total knee replacement and compare this method with continuous femoral nerve block .


Sixty patients scheduled for total knee replacement from June 2013 to March 2014 were randomly divided into a femoral group and an adductor group .


Catheters were placed under the guidance of nerve stimulation in the femoral group and under the guidance of ultrasound in the adductor group .


Operations were performed under combined spinal and epidural anesthesia .


After the operations , 0.2 % ropivacaine was given at a speed of 5 ml/h through catheters in all patients .


Visual analogue scale ( VAS ) pain scores at rest and while moving were noted at 4 , 24 , and 48 hours after the operation , and quadriceps strength was also assessed at these time-points .


Secondary parameters such as doses of complementary analgesics and side effects were also recorded .


There were no significant differences between the groups in VAS pain scores at rest or while moving , at 4 , 24 , or 48 hours after the operation ( P > 0.05 ) .


At these time-points , mean quadriceps strengths in the adductor group were 3.0 ( 2.75-3 .0 ) , 3.0 ( 3.0-4 .0 ) , and 4.0 ( 3.0-4 .0 ) , respectively , all of which were significantly stronger than the corresponding means in the femoral group , which were 2.0 ( 2.0-3 .0 ) , 2.0 ( 2.0-3 .0 ) , and 3.0 ( 2.0-4 .0 ) , respectively ( P < 0.05 ) .


There were no significant differences between the groups in doses of complementary analgesics or side effects ( P > 0.05 ) .


X-ray images of some patients showed that local anesthetic administered into the adductor canal could diffuse upward and reach the femoral triangle .


Continuous adductor canal block with 0.2 % ropivacaine could be used effectively for analgesia after total knee replacement .


Compared with continuous femoral nerve block , this analgesic method has similar analgesic effects and is associated with less weakness of quadriceps muscle .


Comparative effectiveness research ( CER ) has become a major focus of cardiovascular disease investigation to optimize diagnosis and treatment paradigms and decrease healthcare expenditures .


Acute chest pain is a highly prevalent reason for evaluation in the Emergency Department ( ED ) that results in hospital admission for many patients and excess expense .


Improvement in noninvasive diagnostic algorithms can potentially reduce unnecessary admissions .


To compare the performance of treadmill stress echocardiography ( SE ) and coronary computed tomography angiography ( CTA ) in ED chest pain patients with low-to-intermediate risk of significant coronary artery disease .


This is a single-center , randomized controlled trial ( RCT ) comparing SE and CTA head-to-head as the initial noninvasive imaging modality .


The primary outcome measured is the incidence of hospitalization .


The study is powered to detect a reduction in admissions from 28 % to 15 % with a sample size of 400 .


Secondary outcomes include length of stay in the ED/hospital and estimated cost of care .


Safety outcomes include subsequent visits to the ED and hospitalizations , as well as major adverse cardiovascular events at 30days and 1year .


Patients who do not meet study criteria or do not consent for randomization are offered entry into an observational registry .


This RCT will add to our understanding of the roles of different imaging modalities in triaging patients with suspected angina .


It will increase the CER evidence base comparing SE and CTA and provide insight into potential benefits and limitations of appropriate use of treadmill SE in the ED .


Overactive bladder ( OAB ) is highly prevalent and is associated with considerable morbidity and reduced health-related quality of life .


3-adrenergic receptor ( 3-AR ) stimulation is a novel alternative to antimuscarinic therapy for OAB .


The objective of this analysis was to assess the cost effectiveness of the 3-AR agonist mirabegron relative to tolterodine extended release ( ER ) in patients with OAB from a UK National Health Service ( NHS ) perspective .


A Markov model was developed to simulate the management , course of disease , and effect of complications in OAB patients over a period of 5years .


Transition probabilities for symptom severity levels and probabilities of adverse events were estimated from the results of the randomised , double-blind SCORPIO trial in 1,987 patients with OAB .


Other model inputs were derived from the literature and on assumptions based on clinical experience .


Total 5-year costs per patient were 1,645.62 for mirabegron 50mg/day and 1,607.75 for tolterodine ER 4mg/day .


Mirabegron was associated with a gain of 0.009 quality-adjusted life-years ( QALYs ) with an additional cost of 37.88 .


The resulting incremental cost-effectiveness ratio ( ICER ) was 4,386 / QALY gained .


In deterministic sensitivity analyses in the general OAB population and several subgroups , ICERs remained below the generally accepted willingness-to-pay ( WTP ) threshold of 20,000 / QALY gained .


The probability of mirabegron 50mg being cost effective relative to tolterodine ER 4mg was 89.4 % at the same WTP threshold .


Mirabegron 50mg/day is likely to be cost effective compared with tolterodine ER 4mg/day for adult patients with OAB from a UK NHS perspective .


To compare the efficacy of mifepristone and ethacridine lactate with ethacridine lactate alone for second trimester pregnancy termination .


Two hundred and seventy-six healthy women between 16 and 27 weeks of gestation , desiring a termination , were assigned at random into two groups .


The study group consisted of 140 women who received an intra-amniotic injection of 100mg ethacridine lactate , followed by oral administration of 50mg mifepristone at 0 , 12 and 24h ( total dose of mifepristone 150mg ) .


The control group consisted of 136 women who received an intra-amniotic injection of 100mg ethacridine lactate alone .


The primary outcome measure was the induction-to-abortion interval .


Secondary outcomes included blood loss in 24h , successful abortion rate , retained placental tissue rate , rate of uterine evacuation and cervical laceration .


Induction-to-abortion interval , blood loss in 24h , rate of retained placental tissue and uterine evacuation were significantly less in the study group compared with the control group ( p < 0.001 ) .


Termination was successful in 140 of 140 women ( 100 % ) in the study group and 133 of 136 women ( 97.8 % ) in the control group .


All women in the study group delivered within 72h , and three nulliparous women in the control group did not deliver within 72h .


The cervical laceration rate was 0 and 1.47 % ( 2/136 ) in the study group and the control group , respectively .


No significant difference in the successful abortion rate ( p = 0.235 ) or the cervical laceration rate ( p = 0.242 ) was found between the two groups .


Mifepristone in combination with ethacridine lactate may significantly improve the outcomes of second trimester pregnancy termination compared with ethacridine lactate alone , without increasing complications and side effects apart from nausea .


Ticagrelor reduces thrombotic events compared with clopidogrel in patients with acute coronary syndrome , but may also increase bleeding complications .


Coronary artery bypass grafting ( CABG ) - related bleeding complications have not previously been compared in clopidogrel and ticagrelor-treated patients outside the controlled environment of clinical trials .


Four hundred and five consecutive CABG patients with acute coronary syndrome were included in a prospective observational study .


The patients were treated with aspirin and ticagrelor ( n = 173 ) or aspirin and clopidogrel ( n = 232 ) .


Ticagrelor/clopidogrel was discontinued 5 days before surgery whenever deemed possible .


Major bleeding complications according to modified blood conservation using antifibrinolytics in a randomized trial criteria ( postoperative blood loss > 1500 ml/12 h , re-exploration , red blood cell transfusion > 10 units or death because of bleeding ) were compared in all patients and when ticagrelor/clopidogrel was discontinued 5 days ( n = 280 ) , 2-4 days ( n = 40 ) or 0-1 day before surgery ( n = 85 ) .


Major bleeding complications did not differ significantly between ticagrelor - and clopidogrel-treated patients when all patients were compared ( 14.5 vs 13.8 % , P = 0.89 ) .


Likewise , there were no significant differences between ticagrelor and clopidogrel when either drug was discontinued 5 days before surgery ( 6.8 vs 9.9 % , P = 0.40 ) or 2-4 days before surgery ( 6.3 vs 25.0 % , P = 0.21 ) .


When ticagrelor/clopidogrel was discontinued 0-1 day before surgery , there was a strong trend towards higher incidence of major bleeding in ticagrelor-treated patients ( 41.0 vs 21.7 % , P = 0.063 ) .


There was no difference in major bleeding complications overall or when ticagrelor or clopidogrel was used in accordance with guidelines .


In patients on dual antiplatelet medication up to 1 day before surgery , there tended to be more bleeding complications in ticagrelor-treated patients .


Ventilator-associated pneumonia diagnosis remains a debatable topic .


New definitions of ventilator-associated conditions involving worsening oxygenation have been recently proposed to make surveillance of events possibly linked to ventilator-associated pneumonia as objective as possible .


The objective of the study was to confirm the effect of subglottic secretion suctioning on ventilator-associated pneumonia prevalence and to assess its concomitant impact on ventilator-associated conditions and antibiotic use .


Randomized controlled clinical trial conducted in five ICUs of the same hospital .


Three hundred fifty-two adult patients intubated with a tracheal tube allowing subglottic secretion suctioning were randomly assigned to undergo suctioning ( n = 170 , group 1 ) or not ( n = 182 , group 2 ) .


During ventilation , microbiologically confirmed ventilator-associated pneumonia occurred in 15 patients ( 8.8 % ) of group 1 and 32 patients ( 17.6 % ) of group 2 ( p = 0.018 ) .


In terms of ventilatory days , ventilator-associated pneumonia rates were 9.6 of 1,000 ventilatory days and 19.8 of 1,000 ventilatory days , respectively ( p = 0.0076 ) .


Ventilator-associated condition prevalence was 21.8 % in group 1 and 22.5 % in group 2 ( p = 0.84 ) .


Among the 47 patients with ventilator-associated pneumonia , 25 ( 58.2 % ) experienced a ventilator-associated condition .


Neither length of ICU stay nor mortality differed between groups ; only ventilator-associated condition was associated with increased mortality .


The total number of antibiotic days was 1,696 in group 1 , representing 61.6 % of the 2,754 ICU days , and 1,965 in group 2 , representing 68.5 % of the 2,868 ICU days ( p < 0.0001 ) .


Subglottic secretion suctioning resulted in a significant reduction of ventilator-associated pneumonia prevalence associated with a significant decrease in antibiotic use .


By contrast , ventilator-associated condition occurrence did not differ between groups and appeared more related to other medical features than ventilator-associated pneumonia .


Recurrent respiratory infections ( RRI ) constitute a social problem for both the pharmaco-economic impact and the burden for the family .


Pidotimod is a synthetic immunostimulant .


The aim of this study was to evaluate the effects of pidotimod on RRI prevention in children .


Globally , 100 children ( 49 males , mean age 4.7 1.2 years ) with RRI were enrolled in the study .


At baseline , children were randomly assigned to the treatment with pidotimod 400 mg/die or not for two months .


Children were visited at baseline , after 30 ( T1 ) and 60 ( T2 ) days , and at follow-up ( 120 days ; T3 ) .


Number of children with upper and lower airways symptoms , medications use , school attendance , and paediatric visits for RRI were evaluated .


Pidotimod treatment was able of significantly reducing the number of children with upper and lower airways symptoms , and medications use , increasing school attendance , and reducing pediatric visits for RRI .


This study provided the evidence that pidotimod may be able of preventing RRI in children .


Under Food and Drug Administration investigational device exemption , the Prospective Randomized On-X Anticoagulation Clinical Trial ( PROACT ) has been testing the safety of less aggressive anticoagulation than recommended by the American College of Cardiology/American Heart Association guidelines after implantation of an approved bileaflet mechanical valve .


In this first limb of the PROACT , patients with elevated risk factors for thromboembolism were randomized at 33 US centers to receive lower dose warfarin ( test international normalized ratio [ INR ] , 1.5-2 .0 ) or continue standard warfarin ( control INR , 2.0-3 .0 ) , 3 months after mechanical aortic valve replacement .


The INR was adjusted by home monitoring ; all patients received 81 mg aspirin daily .


Adverse events were independently adjudicated .


A total of 375 aortic valve replacement patients were randomized into control ( n = 190 ) and test ( n = 185 ) groups from September 2006 to December 2009 .


The mean age standard deviation was 55.2 12.5 years ; 79 % were men ; and 93 % were in sinus rhythm preoperatively .


Calcific degeneration was present in 67 % ; active endocarditis was excluded .


Concomitant procedures included coronary artery bypass grafting ( 27 % ) , aortic aneurysm repair ( 14 % ) , and other ( 25 % ) .


The follow-up duration averaged 3.82 years ( 755.7 patient-years [ pt-yrs ] for control ; 675.2 pt-yrs for test ) .


The mean INR was 2.50 0.63 for the control and 1.89 0.49 for the test groups ( P < .0001 ) .


The test group experienced significantly lower major ( 1.48 % vs 3.26 % / pt-yr ; P = .047 ) and minor ( 1.32 % vs 3.41 % / pt-yr ; P = .021 ) bleeding rates .


The incidence of stroke , transient ischemic attack , total neurologic events , and all-cause mortality were similar between the 2 groups .


INR can be safely maintained between 1.5 and 2.0 after aortic valve replacement with this approved bileaflet mechanical prosthesis .


With low-dose aspirin , this resulted in a significantly lower risk of bleeding , without a significant increase in thromboembolism .


Addressing the two most important considerations in designing clinical trials , i.e. maximizing study power and minimizing patient exposure to ineffective treatment , is particularly challenging for trials of rare diseases .


The familial Mediterranean fever ( FMF ) rilonacept trial ( Hashkes et al. , Ann Intern Med 2012 ; 157:533 -41 ) demonstrates a novel crossover design by enabling patient choice to early escape for rare disease .


To investigate the effect on study power , exposure to the ineffective treatment arm and dropout rate by implementing early escape to crossover design , and to propose a Bayesian modeling approach .


Based on the FMF trial data , simulation studies compared study power and dropout rate among three types of designs for crossover trial : traditional without early escape , early escape per-patient-choice , and early escape per-protocol .


The early escape per patient choice or per protocol design achieved 0.89 0.12 and 0.78 0.20 of the study efficiency when compared to the traditional crossover design assuming no dropout .


Early escape per patient choice compared to early escape per protocol improved power by 1.29 0.26 , and reduced the dropout rate by 8-29 % , but with greater patient exposure to the less effective treatment arm .


The results of the FMF trial and simulation studies suggest that allowing early escape in crossover trial enhanced the design by minimizing patient 's exposure to the ineffective treatment arm while maintaining a reasonable study power , which is particularly important for rare disease trials .


Choice between the two types of early escape presents tradeoff between study power and exposure to ineffective treatment .


Epidemiological studies suggest that exercise has a tremendous preventative effect on morbidity and premature death , but these findings need to be confirmed by randomised trials .


Generation 100 is a randomised , controlled study where the primary aim is to evaluate the effects of 5years of exercise training on mortality in an elderly population .


All men and women born in the years 1936-1942 ( n = 6966 ) , who were residents of Trondheim , Norway , were invited to participate .


Between August 2012 and June 2013 , a total of 1567 individuals ( 790 women ) were included and randomised to either 5years of two weekly sessions of high-intensity training ( 10min warm-up followed by 44min intervals at 90 % of peak heart rate ) or , moderate-intensity training ( 50min of continuous work at 70 % of peak heart rate ) , or to a control group that followed physical activity advice according to national recommendations .


Clinical examinations , physical tests and questionnaires will be administered to all participants at baseline , and after 1 , 3 and 5years .


Participants will also be followed up by linking to health registries until year 2035 .


The study has been conducted according to the SPIRIT statement .


All participants signed a written consent form , and the study has been approved by the Regional Committee for Medical Research Ethics , Norway .


Projects such as this are warranted in the literature , and we expect that data from this study will result in numerous papers published in world-leading clinical journals ; we will also present the results at international and national conferences .


Clinical trial gov NCT01666340 .


Opioid-induced constipation ( OIC ) is a common adverse effect associated with opioid use .


Naloxegol is a PEGylated derivative of naloxone in clinical development as a once-daily oral treatment of OIC .


A thorough QT/QTc study was conducted , according to International Conference on Harmonisation E14 guidelines , to characterize the effect of naloxegol on cardiac repolarization .


In this randomized , positive - and placebo-controlled crossover study , healthy men received a single dose of naloxegol 25 mg ( therapeutic dose ) , naloxegol 150 mg ( supratherapeutic dose ) , moxifloxacin 400 mg ( positive control ) , or placebo in 1 of 4 sequences ( Williams Latin square design ) .


The washout time between treatment periods was at least 5 days .


Digital 12-lead ECGs were recorded at baseline and at 10 time points over 24 hours after dosing in each treatment period .


QT intervals were corrected for heart rate using the Fridericia formula ( QTcF ) and the Bazett formula ( QTcB ) .


A total of 52 subjects were enrolled ( mean age , 28 years ) , and 45 received all 4 treatments .


The placebo-corrected , baseline-adjusted , mean increases in QTcF with naloxegol 25 and 150 mg were both < 5 msec at each time point , and all upper limits of the 2-sided 90 % CI were < 10 msec .


Similar findings were observed using QTcB ; the upper limits of the 2-sided 90 % CI were < 10 msec at all time points after dosing with naloxegol 25 or 150 mg .


With moxifloxacin 400 mg , mean QTcF was increased by a maximum of 11.1 msec ( 90 % CI , 9.3-12 .9 msec ) , supporting assay sensitivity .


Naloxegol at 25 and 150 mg was not associated with QT/QTc interval prolongation in these healthy men , and at the proposed therapeutic dose of 25 mg/d , naloxegol is not expected to have a clinically relevant effect on cardiac repolarization in patients with OIC .


ClinicalTrials.gov identifier : NCT01325415 .


Assess the effect of counter-advertisements on parents ' appraisals of unhealthy foods featuring front-of-package promotions ( FOPPs ) .


A 2 2 5 between-subjects Web-based experiment .


Parents were randomly shown an advertisement ( counter-advertisement challenging FOPP/control advertisement ) and then a pair of food products from the same category : an unhealthy product featuring an FOPP ( nutrient content claim/sports celebrity endorsement ) and a healthier control product with no FOPP .


Australia .


A total of 1,269 Australian-based parents of children aged 5-12 years recruited from an online panel .


Parents nominated which product they would prefer to buy and which they thought was healthier , then rated the unhealthy product and FOPP on various characteristics .


Differences between advertisement conditions were assessed using logistic regression ( product choice tasks ) and analysis of variance tests ( ratings of unhealthy product and FOPP ) .


Compared with parents who saw a control advertisement , parents who saw a counter-advertisement perceived unhealthy products featuring FOPPs as less healthy , expressed weaker intentions for buying such products , and were more likely to read the nutrition facts panel before nominating choices ( all P < .001 ) .