The occupational physician condition consisted of screening , feedback and referral to the occupational physician for screen-positive nurses .


The third condition included screening , feedback , and referral to e-mental health .


The study was designed as an economic evaluation alongside a pragmatic cluster randomised controlled trial with randomisation at hospital-ward level .


The study included 617 nurses in one academic medical centre in the Netherlands .


Treatment response was defined as an improvement on the Nurses Work Functioning Questionnaire of at least 40 % between baseline and follow-up .


Total per-participant costs encompassed intervention costs , direct medical and non-medical costs , and indirect costs stemming from lost productivity due to absenteeism and presenteeism .


All costs were indexed for the year 2011 .


At 6 months follow-up , significant improvement in work functioning occurred in 20 % , 24 % and 16 % of the participating nurses in the control condition , the occupational physician condition and the e-mental health condition , respectively .


In these conditions the total average annualised costs were 1752 , 1266 and 1375 per nurse .


The median incremental cost-effectiveness ratio for the occupational physician condition versus the control condition was dominant , suggesting cost savings of 5049 per treatment responder .


The incremental cost-effectiveness ratio for the e-mental health condition versus the control condition was estimated at 4054 ( added costs ) per treatment responder .


Sensitivity analyses attested to the robustness of these findings .


The occupational physician condition resulted in greater treatment responses for less costs relative to the control condition and can therefore be recommended .


The e-mental health condition produced less treatment response than the control condition and can not be recommended as an intervention to improve work functioning among nurses .


We have developed a new oral vaccine against enterotoxigenic Escherichia coli ( ETEC ) , which is the most common cause of bacterial diarrhea in children in developing countries and in travelers .


The vaccine was tested for safety and immunogenicity alone and together with double-mutant heat-labile toxin ( dmLT ) adjuvant in a double-blind , placebo-controlled Phase I study in 129 Swedish adults .


The vaccine consists of four inactivated recombinant E. coli strains overexpressing the major ETEC colonization factors ( CFs ) CFA/I , CS3 , CS5 , and CS6 mixed with an LT B-subunit related toxoid , LCTBA .


Volunteers received two oral doses of vaccine alone , vaccine plus 10 g or 25 g dmLT or placebo .


Secretory IgA antibody responses in fecal samples and IgA responses in secretions from circulating intestine-derived antibody secreting cells were assessed as primary measures of vaccine immunogenicity .


The vaccine was safe and well tolerated ; adverse events were few and generally mild with no significant differences between subjects receiving placebo or vaccine with or without adjuvant .


As many as 74 % of subjects receiving vaccine alone and 83 % receiving vaccine plus 10 g dmLT showed significant mucosal IgA responses to all five primary vaccine antigens and about 90 % of all vaccinees responded to at least four of the antigens .


Subjects receiving vaccine plus 10 g dmLT responded with significantly increased intestine-derived anti-CS6 responses compared to subjects receiving vaccine alone .


The vaccine was safe and broadly immunogenic .


dmLT further enhanced mucosal immune responses to CF antigens present in low amounts in the vaccine .


Based on these encouraging results , the vaccine will be tested for safety and immunogenicity in different age groups including infants in Bangladesh and for protective efficacy in travelers .


In the Action in Diabetes and Vascular Disease : Preterax and Diamicron Modified Release Controlled Evaluation ( ADVANCE ) factorial trial , the combination of perindopril and indapamide reduced mortality among patients with type 2 diabetes , but intensive glucose control , targeting a glycated hemoglobin level of less than 6.5 % , did not .


We now report results of the 6-year post-trial follow-up .


We invited surviving participants , who had previously been assigned to perindopril-indapamide or placebo and to intensive or standard glucose control ( with the glucose-control comparison extending for an additional 6 months ) , to participate in a post-trial follow-up evaluation .


The primary end points were death from any cause and major macrovascular events .


The baseline characteristics were similar among the 11,140 patients who originally underwent randomization and the 8494 patients who participated in the post-trial follow-up for a median of 5.9 years ( blood-pressure-lowering comparison ) or 5.4 years ( glucose-control comparison ) .


Between-group differences in blood pressure and glycated hemoglobin levels during the trial were no longer evident by the first post-trial visit .


The reductions in the risk of death from any cause and of death from cardiovascular causes that had been observed in the group receiving active blood-pressure-lowering treatment during the trial were attenuated but significant at the end of the post-trial follow-up ; the hazard ratios were 0.91 ( 95 % confidence interval [ CI ] , 0.84 to 0.99 ; P = 0.03 ) and 0.88 ( 95 % CI , 0.77 to 0.99 ; P = 0.04 ) , respectively .


No differences were observed during follow-up in the risk of death from any cause or major macrovascular events between the intensive-glucose-control group and the standard-glucose-control group ; the hazard ratios were 1.00 ( 95 % CI , 0.92 to 1.08 ) and 1.00 ( 95 % CI , 0.92 to 1.08 ) , respectively .


The benefits with respect to mortality that had been observed among patients originally assigned to blood-pressure-lowering therapy were attenuated but still evident at the end of follow-up .


There was no evidence that intensive glucose control during the trial led to long-term benefits with respect to mortality or macrovascular events .


( Funded by the National Health and Medical Research Council of Australia and others ; ADVANCE-ON ClinicalTrials.gov number , NCT00949286 . )


To evaluate , posthoc , the relationship between serum total testosterone and response to therapy in a study of tadalafil once daily for erectile dysfunction ( ED ) .


Men were aged 18 years , with 3-month history of ED and partial prior response to on-demand ( PRN ) phosphodiesterase type 5 inhibitor ( PDE5I ) therapy .


A 4-week maximum-dose PRN PDE5I run-in was followed by a 4-week nondrug washout period , then randomization to tadalafil 2.5 mg titrated to 5 mg or tadalafil 5 mg ( pooled for analyses ) or placebo once daily for 12 weeks .


Analyses compared endpoint efficacy results between low - ( < 300 ng/dL ) vs normal-testosterone ( 300 ng/dL ) level subgroups .


Improvements for tadalafil vs placebo were significant for the International Index of Erectile Function ( IIEF ) Erectile Function domain , Intercourse Satisfaction domain , Overall Satisfaction domain , and Question 15 ( confidence in the ability to get and keep an erection ; all P < .001 ) , and for the Sexual Encounter Profile Questions 1-5 ( all P. 011 ) .


Analysis of covariance modeling identified significant treatment-by-subgroup interactions for the IIEF-Overall Satisfaction domain and erection confidence question and Sexual Encounter Profile Question 3 .


Comparing between tadalafil-treated testosterone subgroups , the IIEF-Erectile Function domain scores improved significantly more in men with normal vs low testosterone ( P = .022 ) ; no other significant differences were identified for either placebo or tadalafil .


No significant differences in pre-existing conditions were observed between tadalafil and placebo within the normal - and low-testosterone subgroups .


In men with partial response to a PRN PDE5I , tadalafil 5 mg once daily significantly improved ED and sexual function vs placebo irrespective of testosterone levels .


Meaning-focused coping may be at the core of adequate adjustment to life after cancer .


Cancer survivors who experience their life as meaningful are better adjusted , have better quality of life and psychological functioning .


Meaning-Centered Group Psychotherapy for Cancer Survivors ( MCGP-CS ) was designed to help patients to sustain or enhance a sense of meaning and purpose in their lives .


The aim of the proposed study is to evaluate the effectiveness and cost-effectiveness of MCGP-CS .


Survivors diagnosed with cancer in the last 5 years and treated with curative intent , are recruited via several hospitals in the Netherlands .


After screening , 168 survivors are randomly assigned to one of the three study arms : 1 .


Meaning-Centered Group Psychotherapy ( MCGP-CS ) 2 .


Supportive group psychotherapy ( SGP ) 3 .


Care as usual ( CAU ) .


Baseline assessment takes place before randomisation , with follow up assessments post-intervention and at 3 , 6 and 12 months follow-up .


Primary outcome is meaning making ( PMP , PTGI , SPWB ) .


Secondary outcome measures address quality of life ( EORTC-30 ) , anxiety and depression ( HADS ) , hopelessness ( BHS ) , optimism ( LOT-R ) , adjustment to cancer ( MAC ) , and costs ( TIC-P , EQ-5D , PRODISQ ) .


Meaning-focused coping is key to adjustment to life after cancer , however , there is a lack of evidence based psychological interventions in this area .


Many cancer survivors experience feelings of loneliness and alienation , and have a need for peer support , therefore a group method in particular , can be beneficial for sustaining or enhancing a sense of meaning .


If this MCGP-CS is effective for cancer survivors , it can be implemented in the practice of psycho-oncology care .


Netherlands Trial Register , NTR3571 .


The current standard treatment for IgA nephropathy relies on steroid and/or immunosuppressive therapy and angiotensin converting enzyme inhibitors ( ACEI ) or angiotensin receptor blocker ( ARB ) .


This study examines the benefits and safety of combining valsartan with clopidogrel and leflunomide as a treatment for progressive IgA nephropathy .


Patients with primary IgA nephropathy , confirmed by renal biopsy , were recruited for this study .


Patients were separated into four groups ( n = 42 each ) after 2 months of run-in period of valsartan treatment .


All patients were treated with valsartan alone ( Group 1 ) or valsartan and either clopidogrel ( Group 2 ) or leflunomide ( Group 3 ) or both clopidogrel and leflunomide ( Group 4 ) .


Each group was followed up for their next 24 months for 24h urinary protein excretion , serum creatinine and estimated glomerular filtration rate ( eGFR ) to assess the effect of the treatment .


Adverse effects were recorded concurrently to evaluate the safety of the treatment .


Of all 168 patients , 107 were males and 61 were females , with an average age of 33.88.79 years .


Baseline characteristics were comparable among the four groups ( P > 0.05 ) prior to the experimental treatment .


There was a significant ( P < 0.05 ) decrease in 24h urinary protein excretion after 4 months of experimental treatment .


At the end of the 24 months , groups 3 and 4 showed a respective 62.35 % and 69.47 % reduction in proteinuria .


The serum creatinine was significantly higher ( P < 0.05 ) in group 1 and 2 at the end of the follow-up , and their respective eGFR was significantly lower .


The incidence of cardiovascular complication was 11.9 % and 9.5 % for group 1 and 3 , respectively .


The treatment with Valsartan combined with Clopidogrel and Leflunomide can reduce the urinary proteins loss and renal function deterioration for IgA nephropathy patients and cause minimal adverse reactions .


Our study suggests a new clinical treatment option for IgA nephropathy .


This study sought to examine the relationship between left ventricular mass ( LVM ) regression and clinical outcomes after transcatheter aortic valve replacement ( TAVR ) .


LVM regression after valve replacement for aortic stenosis is assumed to be a favorable effect of LV unloading , but its relationship to improved clinical outcomes is unclear .


Of 2,115 patients with symptomatic aortic stenosis at high surgical risk receiving TAVR in the PARTNER ( Placement of Aortic Transcatheter Valves ) randomized trial or continued access registry , 690 had both severe LV hypertrophy ( left ventricular mass index [ LVMi ] 149 g/m ( 2 ) men , 122 g/m ( 2 ) women ) at baseline and an LVMi measurement at 30-day post-TAVR follow-up .


Clinical outcomes were compared for patients with greater than versus lesser than median percentage change in LVMi between baseline and 30 days using Cox proportional hazard models to evaluate event rates from 30 to 365 days .


Compared with patients with lesser regression , patients with greater LVMi regression had a similar rate of all-cause mortality ( 14.1 % vs. 14.3 % , p = 0.99 ) , but a lower rate of rehospitalization ( 9.5 % vs. 18.5 % , hazard ratio [ HR ] : 0.50 , 95 % confidence interval [ CI ] : 0.32 to 0.78 ; p = 0.002 ) and a lower rate of rehospitalization specifically for heart failure ( 7.3 % vs. 13.6 % , p = 0.01 ) .


The association with a lower rate of rehospitalization was consistent across subgroups and remained significant after multivariable adjustment ( HR : 0.53 , 95 % CI : 0.34 to 0.84 ; p = 0.007 ) .


Patients with greater LVMi regression had lower B-type natriuretic peptide ( p = 0.002 ) and a trend toward better quality of life ( p = 0.06 ) at 1-year follow-up than did those with lesser regression .


In high-risk patients with severe aortic stenosis and severe LV hypertrophy undergoing TAVR , those with greater early LVM regression had one-half the rate of rehospitalization over the subsequent year compared to those with lesser regression .


Percutaneous coronary interventions in patients with chronic kidney disease have shown suboptimal results .


Drug-eluting stents ( DES ) might reduce the rate of target vessel revascularization in comparison with bare-metal stents ( BMS ) in patients with chronic kidney disease .


However , given the multiple concomitant individual variables present in such patients , the comparison of neointimal growth after percutaneous coronary intervention is complex and difficult to assess .


Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient with Chronic Kidney Disease ( RENAL-DES ) was a prospective , randomized , multicenter study to directly compare the efficacy in the prevention of clinical restenosis of everolimus-eluting stent ( Xience V ) and BMS with an identical design ( Multi-Link Vision ) , both implanted in the same patient with multivessel coronary artery disease and chronic kidney disease ( estimated glomerular filtration rate < 60 mL/min ) .


The primary end point of the study was the ischemia-driven target vessel revascularization as detected with myocardial scintigraphy at 12 months .


In 215 patients , 512 coronary vessels were successfully treated with the randomly assigned DES ( n = 257 ) or BMS ( n = 255 ) .


At 1 year , the rate of ischemia-driven target vessel revascularization for DES and BMS groups was 2.7 % ( 95 % confidence interval , 1.1 % -5.6 % ) and 11.4 % ( 95 % confidence interval , 7.8 % to 16 % ) , respectively , P < 0.001 .


For the multivariate analysis , independent predictors of the ischemia-driven target vessel revascularization were BMS implantation ( odds ratio , 4.95 ; 95 % confidence interval , 2.1-11 .6 ; P < 0.001 ) and vessel size ( odds ratio , 0.32 ; 95 % confidence interval , 0.1-0 .7 ; P = 0.006 ) .


This is the first randomized trial showing a reduction of clinical restenosis with a new-generation DES in comparison with a BMS of equal design , in patients who have chronic kidney disease with multivessel coronary artery disease .


http://clinicaltrials.gov .


Unique identifier : NCT00818792 .


Emergence agitation ( EA ) is frequently observed in children undergoing general anaesthesia .


This study tested whether the addition of an intra-operative low-dose infusion of dexmedetomidine to fentanyl treatment reduced the incidence of emergence delirium following desflurane anesthesia in children undergoing strabismus surgery .


A total of 96 children ( 1-5 years old ) undergoing strabismus surgery were enrolled .


Anaesthesia was induced with propofol and maintained with desflurane .


After induction , fentanyl ( 1 g/kg ) was administered to all children .


During surgery , patients were infused with 0.2 g / ( kgh ) dexmedetomidine ( Group FD , n = 47 ) or normal saline ( Group F , n = 47 ) .


Postoperative objective pain score ( OPS ) , Paediatric Agitation and Emergence Delirium ( PAED ) score , and EA score were documented every 10 minutes in the post-anaesthesia care unit .


There were no significant differences between the two groups in demographic characteristics and haemodynamic changes .


The mean values of maximum EA , maximum PAED , and maximum OPS score were significantly lower in Group FD than in Group F at 0 , 10 , and 20 minutes after arrival at the post-anaesthesia care unit ( p < 0.001 ) .


The frequency of fentanyl rescue was lower in Group FD than in Group F ( p < 0.001 ) .


The incidence of severe EA was significantly lower in Group FD than in Group F ( 12.8 % vs. 74.5 % , p < 0.001 ) .


Intra-operative low-dose infusion of dexmedetomidine in addition to fentanyl reduces EA following desflurane anaesthesia in children undergoing strabismus surgeries .


To determine the effect of enclomiphene citrate in men with secondary hypogonadism .


Phase II clinical trial .


Community dwelling men making visits to physician offices .


Men with secondary hypogonadism .


Oral administration of enclomiphene citrate or 1 % topical T gel .


Luteinizing hormone , FSH , T , and semen analysis .


Treatment with enclomiphene citrate resulted in increased morning serum T , E2 , and LH levels similar to those obtained with a topical T gel in men with secondary hypogonadism .


Follicle-stimulating hormone and LH were increased with enclomiphene , and sperm counts were conserved .


Enclomiphene citrate reverses the two hallmarks of secondary hypogonadism , namely , low serum total T and low or inappropriately normal LH while preserving sperm production .


NCT01270841 ( ClinicalTrials.gov Identifier NCT01270841 ) .


Randomized prevention trial .


To compare the long-term effect of strengthening versus flexibility exercises and to evaluate the additional effect of abdominal bracing in recurrent low back pain ( LBP ) .


No conclusions could be made regarding appropriate exercise types or parameters in recurrent LBP .


Abdominal bracing increases trunk stiffness ; however , its long-term effect has not been evaluated in recurrent LBP yet .


Six hundred patients with recurrent LBP participated .


They were randomized into 4 groups-150 patients ( age : 42.5 12.7 ) performed strengthening exercises ; 150 patients ( age : 41.3 11.5 ) performed flexibility exercises ; 150 patients ( age : 41.0 13.2 ) performed strengthening exercises and used abdominal bracing in daily activities/exercises ; and 150 patients ( age : 40.6 12.3 ) performed flexibility exercises and used abdominal bracing in daily activities/exercises .


At the beginning of the study and at the end of 10 consecutive years were recorded 6 outcomes-frequency , intensity , and duration of pain , as well as frequency , intensity , and duration of exercises .


Regarding the first 4 outcomes-all groups showed improvement from the beginning to the second year , but worsening from the second to the 10th year ; there was no difference between strengthening and flexibility groups ; bracing groups showed better results versus nonbracing groups .


Intensity , frequency , and duration of the pain correlated with each other and with frequency of the exercises , but not with exercise duration or intensity .


The exercise frequency is more important than the type , duration , or intensity of the exercise .


Abdominal bracing adds to the exercise effect .


It could be considered as a `` preliminary muscle back belt on demand '' increasing the trunk stiffness and the frequency of the trunk muscle contractions/cocontractions without interruption of daily activities , which may remind/convince the patients to exercise more frequently .


Frequent exercising and bracing seems effective long-term prevention advices in recurrent LBP .


2 .


Methotrexate and infliximab are effective therapies for Crohn 's disease ( CD ) .


In the combination of maintenance methotrexate-infliximab trial , we evaluated the potential superiority of combination therapy over infliximab alone .


In a 50-week , double-blind , placebo-controlled trial , we compared methotrexate and infliximab with infliximab alone in 126 patients with CD who had initiated prednisone induction therapy ( 15-40 mg/day ) within the preceding 6 weeks .


Patients were assigned randomly to groups given methotrexate at an initial weekly dose of 10 mg , escalating to 25 mg/week ( n = 63 ) , or placebo ( n = 63 ) .


Both groups received infliximab ( 5 mg/kg of body weight ) at weeks 1 , 3 , 7 , and 14 , and every 8 weeks thereafter .


Prednisone was tapered , beginning at week 1 , and discontinued no later than week 14 .


The primary outcome was time to treatment failure , defined as a lack of prednisone-free remission ( CD Activity Index , < 150 ) at week 14 or failure to maintain remission through week 50 .


Patients ' baseline characteristics were similar between groups .


By week 50 , the actuarial rate of treatment failure was 30.6 % in the combination therapy group compared with 29.8 % in the infliximab monotherapy group ( P = .63 ; hazard ratio , 1.16 ; 95 % confidence interval , 0.62-2 .17 ) .


Prespecified subgroup analyses failed to show a benefit in patients with short disease duration or an increased level of C-reactive protein .


No clinically meaningful differences were observed in secondary outcomes .


Combination therapy was well tolerated .


The combination of infliximab and methotrexate , although safe , was no more effective than infliximab alone in patients with CD receiving treatment with prednisone .


ClincialTrials.gov number , NCT00132899 .


Knee osteoarthritis ( OA ) is a mechanically driven disease , and it is suggested that medial tibiofemoral knee-joint load increases with pharmacologic pain relief , indicating that pharmacologic pain relief may be positively associated with disease progression .


Treatment modalities that can both relieve pain and reduce knee-joint load would be preferable .


The knee-joint load is influenced by functional alignment of the trunk , pelvis , and lower-limb segments with respect to the knee , as well as the ground-reaction force generated during movement .


Neuromuscular exercise can influence knee load and decrease knee pain .


It includes exercises to improve balance , muscle activation , functional alignment , and functional knee stability .


The primary objective of this randomized controlled trial ( RCT ) is to investigate the efficacy of a NEuroMuscular EXercise ( NEMEX ) therapy program , compared with optimized analgesics and antiinflammatory drug use , on the measures of knee-joint load in people with mild to moderate medial tibiofemoral knee osteoarthritis .


One hundred men and women with mild to moderate medial knee osteoarthritis will be recruited from general medical practices and randomly allocated ( 1:1 ) to one of two 8-week treatments , either ( a ) NEMEX therapy twice a week or ( b ) information on the recommended use of analgesics and antiinflammatory drugs ( acetaminophen and oral NSAIDs ) via a pamphlet and video materials .


The primary outcome is change in knee load during walking ( the Knee Index , a composite score of the first external peak total reaction moment on the knee joint from all three planes based on 3D movement analysis ) after 8 weeks of intervention .


Secondary outcomes include changes in the external peak knee-adduction moment and impulse and functional performance measures , in addition to changes in self-reported pain , function , health status , and quality of life .


These findings will help determine whether 8 weeks of neuromuscular exercise is superior to optimized use of analgesics and antiinflammatory drugs regarding knee-joint load , pain and physical function in people with mild to moderate knee osteoarthritis .


ClinicalTrials.gov Identifier : NCT01638962 ( July 3 , 2012 ) .


This study evaluated the long-term effectiveness of multiple physical activity counseling strategies on subjective health among older adults .


Sedentary older adults ( n = 442 ) were randomized to 3 programs : ( 1 ) a one-contact referral to locally organized physical activities , ( 2 ) a one-contact provision of a walking program , ( 3 ) a 10-week multiple-contact physical activity coaching based on the Self-Determination Theory .


Self-reports on well-being , trait anxiety and physical activity were completed at baseline ( pretest ) , and 10 weeks after ( 10-week follow-up ) , 1 year after ( 1-year follow-up ) and 2 years after ( 2-year follow-up ) pretests .


All 3 programs yielded improvements in well-being and trait anxiety from pretest to 10-week follow-up and to 1-year follow-up .


From pretest to 2-year follow-up , no changes emerged in well-being whereas trait anxiety increased significantly .


Changes over time in well-being and anxiety were not significantly different between the programs .


Changes in physical activity contributed significantly to the prediction of changes in well-being and trait anxiety .


The findings demonstrate the year-round effectiveness of physical activity counseling on subjective health among older adults , irrespective of counseling strategy .


However , a relapse to baseline level occurred 2 years after the intervention .


Physical activity appears to be an important determinant of older adults ' well-being .


Azathioprine ( AZA ) , a pro-drug metabolised to the active metabolites 6-tioguanine nucleotides ( 6TGN ) , is a steroid-sparing therapy for Crohn 's disease ( CD ) .


To investigate whether AZA therapy is optimised by individualised dosing based on thiopurine methyltransferase ( TPMT ) activity and 6TGN concentrations .


This multicentre , double-blind , randomised controlled trial compared the efficacy and safety of weight-based vs. individualised AZA dosing in inducing and maintaining remission in adults and children with steroid-treated CD .


The primary outcome was clinical remission ( CR ) at 16 weeks .


In the weight-based arm , subjects received 2.5 mg/kg/day .


In the individualised dosing arm , the initial AZA dose was 1.0 mg/kg/day ( if intermediate TPMT ) or 2.5 mg/kg/day ( if normal TPMT ) .


Starting at week 5 , the dose was adjusted to target 6TGN concentrations of 250-400 pmol/8 10 ( 8 ) red blood cells ( RBC ) , or to a maximal dose of 4 mg/kg/day .


After randomising 50 subjects , the trial was stopped prematurely due to insufficient enrolment .


In intention-to-treat analysis , CR rates at week 16 were 40 % in the individualised arm vs. 16 % in the weight-based arm ( P = 0.11 ) .


In per-protocol ( PP ) analysis , week 16 CR rates were 60 % in the individualised arm and 25 % in the weight-based arm ( P = 0.12 ) .


At week 16 , median 6TGN concentrations in PP remitters and nonremitters were 216 and 149 pmol/8 10 ( 8 ) RBC respectively ( P = 0.07 ) .


Despite trends favouring individualised over weight-based AZA dosing , there were no statistically significant differences in efficacy , likely due to low statistical power and inability to achieve the target 6TGN concentrations in the individualised arm .


[ Clinicaltrials.Gov Identifier Nct00113503 ] .


To evaluate the efficacy and feasibility of actions intended to implement or improve patients ' social network within the Italian National Health Service community mental health services .


We conducted a randomized clinical trial through a network of 47 community mental health services on patients with a diagnosis in the schizophrenia spectrum ( F20 in the International Classification of Diseases , 10th Revision ) , who were young ( aged younger than 45 years ) , and with a poor social network ( less than 5 relationships ) .


In addition to routine treatments , for the experimental group , the staff identified possible areas of interest for individual patients and proposed social activities taking place outside the services ' resources and with members of the community .


The main outcome was an improvement in the patients ' social network ; secondary end points were clinical outcome , abilities of daily living , and work .


One - and 2-year outcomes of 345 and 327 , respectively , of the 357 patients randomized were analyzed by intention-to-treat .


A social network improvement was observed at year 1 in 25 % of the patients allocated to routine treatment and in 39.9 % of those allocated to the experimental arm ( OR 2.0 , 95 % CI 1.3 to 3.1 ; adjusted OR 2.4 , 95 % CI 1.4 to 3.9 ) .


The difference remained statistically significant at year 2 .


No significant differences emerged for any of the other end points .


However , patients with 1 or more other areas of improvement at year 1 and 2 showed a statistically significant social network improvement .


The activation of social networks as an activity integrated with standard psychiatric care is practicable , without added economic and organizational costs , and appears to produce an effect persisting well beyond its implementation .


Serotonin reuptake inhibitors ( SSRIs ) are commonly prescribed off-label for children with autism .


To date , clinical trials examining the use of SSRIs in autism have been limited by small sample sizes and inconclusive results .


The efficacy and safety of SSRIs for moderating autistic behaviors is yet to be adequately examined to provide evidence to support current clinical practice .


The aim of the Fluoxetine for Autistic Behaviors ( FAB ) study is to determine the efficacy and safety of low dose fluoxetine compared with placebo , for reducing the frequency and severity of repetitive stereotypic behaviors in children and adolescents with an autism spectrum disorder ( ASD ) .


The relationship between the effectiveness of fluoxetine treatment and serotonin transporter genotype will also be explored .


The FAB study is a multicenter , double-blinded , randomized controlled trial , funded by the Australian Government 's National Health and Medical Research Council ( NHMRC ) grant .


Participants will be aged between 7.5 and 17 years with a confirmed diagnosis of ASD .


Eligible participants will be randomized to either placebo or fluoxetine for a 16-week period .


Medication will be titrated over the first four weeks .


Reponses to medication will be monitored fortnightly using the Clinical Global Impressions Scale ( CGI ) .


The primary outcome measure is the Children 's Yale-Brown Obsessive Compulsive Scale-Modified for Pervasive Developmental Disorders ( CYBOCS-PDD ) , administered at baseline and 16 weeks .


Secondary outcome measures include the Aberrant Behaviour Scale ( ABC ) , the Spence Children 's Anxiety Scale Parent Report ( SCAS-P ) , and the Repetitive Behaviors Scale ( RBS-R ) , measured at baseline and 16 weeks .


Participants will be invited to undergo genetic testing for SLC6A4 allele variants using a cheek swab .


Continuous outcomes , including the primary outcome will be compared between the active and placebo groups using unadjusted linear regression .


Binary outcomes will be compared using unadjusted logistic regression .


The FAB study is a large clinical trial to specifically investigate the efficacy of low dose fluoxetine for restricted , repetitive , and stereotyped behaviors in ASD .


The outcomes of this study will contribute to evidence-based interventions used in clinical practice to assist children with ASD .


Australian and New Zealand Clinical Trials Registry ACTRN12608000173392 ; registered on 9 April , 2008 .


Our study examined whether mindfulness-based stress reduction ( MBSR ) is noninferior to cognitive behavioral therapy for insomnia ( CBT-I ) for the treatment of insomnia in patients with cancer .


This was a randomized , partially blinded , noninferiority trial involving patients with cancer with insomnia recruited from a tertiary cancer center in Calgary , Alberta , Canada , from September 2008 to March 2011 .


Assessments were conducted at baseline , after the program , and after 3 months of follow-up .


The noninferiority margin was 4 points measured by the Insomnia Severity Index .


Sleep diaries and actigraphy measured sleep onset latency ( SOL ) , wake after sleep onset ( WASO ) , total sleep time ( TST ) , and sleep efficiency .


Secondary outcomes included sleep quality , sleep beliefs , mood , and stress .


Of 327 patients screened , 111 were randomly assigned ( CBT-I , n = 47 ; MBSR , n = 64 ) .


MBSR was inferior to CBT-I for improving insomnia severity immediately after the program ( P = .35 ) , but MBSR demonstrated noninferiority at follow-up ( P = .02 ) .


Sleep diary-measured SOL was reduced by 22 minutes in the CBT-I group and by 14 minutes in the MBSR group at follow-up .


Similar reductions in WASO were observed for both groups .


TST increased by 0.60 hours for CBT-I and 0.75 hours for MBSR .


CBT-I improved sleep quality ( P < .001 ) and dysfunctional sleep beliefs ( P < .001 ) , whereas both groups experienced reduced stress ( P < .001 ) and mood disturbance ( P < .001 ) .


Although MBSR produced a clinically significant change in sleep and psychological outcomes , CBT-I was associated with rapid and durable improvement and remains the best choice for the nonpharmacologic treatment of insomnia .


To observe the different concentrations of mycophenolic acid ( MPA ) during the early post-transplant phase for various combinations of cyclosporine A ( CsA ) and tacrolimus ( Tac ) with enteric-coated mycophenolate sodium ( EC-MPS ) .


A total of 42 Chinese adults receiving live related donor kidney transplants were studied .


All received a triple immunosuppressive regimen of EC-MPS , CsA/Tac and corticosteroids and were divided randomly into CsA ( n = 21 ) and Tac ( n = 21 ) combination groups .


The dosage of EC-MPS was the same ( 1440mg/day ) in the two groups .


The MPA concentration was evaluated with an enzyme-multiplied immunoassay technique ( EMIT ) and the pharmacokinetic characteristics were investigated in both groups .


The mean maximum plasma concentrations ( Cmax ) of MPA in the CsA and Tac groups were 11.3659.522 and 9.7487.523 g/ml , respectively ( p = 0.137 ) .


The maximum times to Cmax ( Tmax ) were 2.541.53 and 2.671.08 h , respectively ( p = 0.341 ) .


The mean MPA 12-h areas under the curve ( MPA-AUC0-12h ) were 59.46316.252 and 77.53533.615 gh/ml ( p = 0.003 ) and the mean residence times ( MRT ) were 3.710.829 and 3.9280.923 h ( p = 0.038 ) .


Combined with the same EC-MPS dosage ( 1440mg/day ) , the MPA-AUC0-12 of the Tac group was higher than that of the CsA group , and the Tac group had a longer MRT after kidney transplantation .


Our data indicate that the concentration of MPA should be monitored in clinical therapy when EC-MPS is combined with different calcineurin inhibitors to reduce acute allograft rejection and avoid adverse events .


Functional dyspepsia ( FD ) is a complex disease with a variety of dyspeptic symptoms .


Little is known about the clinical efficacy of cinitapride , a 5-HT agonist and D antagonist , in treating FD .


This randomized , double-blind , double-dummy , positive-controlled study compared the efficacy and safety of cinitapride ( 1 mg ) and domperidone ( 10 mg ) tid for 4 weeks in 383 consecutive patients with mild to moderate , postprandial distress syndrome-predominant dyspeptic symptoms according to Rome III criteria .


The primary endpoint was the noninferiority of cinitapride compared with domperidone in relief of symptoms .


The overall patient evaluation of treatment and open gastric emptying effects of both drugs were treated as the secondary endpoints .


The rates of symptom relief by cinitapride and domperidone after 4 weeks did not differ significantly on intension-to-treat analysis ( 85.8 % vs. 81.8 % , P = 0.332 ) .


Cinitapride significantly reduced the overall severity of postprandial fullness , early satiation , and bloating ( 4.33.9 vs. 17.86.6 , P < 0.001 ) ; and it was superior to the effects of domperidone ( 5.44.9 vs. 18.46.9 , P < 0.001 ; P = 0.021 between groups ) .


Cinitapride also decreased the mean half-gastric emptying time from 131.1119.4 to 86.518.7 minutes ( P = 0.0002 ) .


There was a positive relationship between symptoms and gastric emptying time ( r = 0.332 , P = 0.041 ) .


Cinitapride-related adverse events were observed in 9.1 % of patients , including 1 patient with extrapyramidal symptoms .


No patient experienced QT interval prolongation .


This phase III trial has confirmed a noninferior efficacy of cinitapride over domperidone for patients with mild to moderate , postprandial distress syndrome-predominant FD .


Cinitapride usage is well tolerated , but its cardiovascular events need further evaluation .


To conduct a randomized controlled trial of Students for Nutrition and eXercise , a 5-week middle school-based obesity-prevention intervention combining school-wide environmental changes , multimedia , encouragement to eat healthy school cafeteria foods , and peer-led education .


We randomly selected schools ( five intervention , five waitlist control ) from the Los Angeles Unified School District .


School records were obtained for number of fruits and vegetables served , students served lunch , and snacks sold per attending student , representing an average of 1,515 students ( SD = 323 ) per intervention school and 1,524 students ( SD = 266 ) per control school .


A total of 2,997 seventh-graders ( 75 % of seventh-graders across schools ) completed pre - and postintervention surveys assessing psychosocial variables .


Consistent with community-based participatory research principles , the school district was an equal partner , and a community advisory board provided critical input .


Relative to control schools , intervention schools showed significant increases in the proportion of students served fruit and lunch and a significant decrease in the proportion of students buying snacks at school .


Specifically , the intervention was associated with relative increases of 15.3 % more fruits served ( p = .006 ) , 10.4 % more lunches served ( p < .001 ) , and 11.9 % fewer snacks sold ( p < .001 ) than would have been expected in its absence .


Pre-to-post intervention , intervention school students reported more positive attitudes about cafeteria food ( p = .02 ) and tap water ( p = .03 ) , greater obesity-prevention knowledge ( p = .006 ) , increased intentions to drink water from the tap ( p = .04 ) or a refillable bottle ( p = .02 ) , and greater tap water consumption ( p = .04 ) compared with control school students .


Multilevel school-based interventions may promote healthy adolescent dietary behaviors .


Abnormal acid gastro-oesophageal reflux is common in patients with idiopathic pulmonary fibrosis ( IPF ) and is considered a risk factor for development of IPF .


Retrospective studies have shown improved outcomes in patients given anti-acid treatment .


The aim of this study was to investigate the association between anti-acid treatment and disease progression in IPF .


In an analysis of data from three randomised controlled trials , we identified patients with IPF assigned to receive placebo .


Case report forms had been designed to prospectively obtain data about diagnosis and treatment of abnormal acid gastro-oesophageal reflux in each trial .


The primary outcome was estimated change in forced vital capacity ( FVC ) at 30 weeks ( mean follow-up ) in patients who were and were not using a proton-pump inhibitor or histamine-receptor-2 ( H2 ) blocker .


Of the 242 patients randomly assigned to the placebo groups of the three trials , 124 ( 51 % ) were taking a proton-pump inhibitor or H2 blocker at enrolment .


After adjustment for sex , baseline FVC as a percentage of predicted , and baseline diffusing capacity of the lung for carbon monoxide as a percentage of predicted , patients taking anti-acid treatment at baseline had a smaller decrease in FVC at 30 weeks ( -006 L , 95 % CI -011 to -001 ) than did those not taking anti-acid treatment ( -012 L , -017 to -008 ; difference 007 L , 95 % CI 0-014 ; p = 005 ) .


Anti-acid treatment could be beneficial in patients with IPF , and abnormal acid gastro-oesophageal reflux seems to contribute to disease progression .


Controlled clinical trials of anti-acid treatments are now needed .


National Institutes of Health .


The purpose of this study was to test for moderating effects of patient characteristics on self-management interventions developed to address symptoms during cancer treatment .


Patient 's age , education , and depressive symptomatology were considered as potential moderators .


A secondary analysis of data of 782 patients from two randomized clinical trials was performed .


Both trials enrolled patients with solid tumors undergoing chemotherapy .


After completing baseline interviews , patients were randomized to a nurse-delivered intervention versus intervention delivered by a ` coach ' in trial I and to a nurse-delivered intervention versus an intervention delivered by an automated voice response system in trial II .


In each of the two trials , following a six-contact 8-week intervention , patients were interviewed at week 10 to assess the primary outcome of symptom severity .


Although nurse-delivered intervention proved no better than the coach or automated system in lowering symptom severity , important differences in the intervention by age were found in both trials .


Patients aged 45 years responded better to the coach or automated system , whereas those aged 75 years favored the nurse .


Education and depressive symptomatology did not modify the intervention effects in either of the two trials .


Depressive symptomatology had a significant main effect on symptom severity at week 10 in both trials ( p = 0.03 and p < 0.01 , respectively ) .


Education was not associated with symptom severity over and above age and depressive symptomatology .


Clinicians need to carefully consider the age of the population when using or testing interventions to manage symptoms among cancer patients .


The Integrated Infectious Diseases Capacity Building Evaluation ( IDCAP ) designed two interventions : Integrated Management of Infectious Disease ( IMID ) training program and On-Site Support ( OSS ) .


We evaluated their effects on 23 facility performance indicators , including malaria case management .


IMID , a three-week training with two follow-up booster courses , was for two mid - level practitioners , primarily clinical officers and registered nurses , from 36 primary care facilities .


OSS was two days of training and continuous quality improvement activities for nine months at 18 facilities , to which all health workers were invited to participate .


Facilities were randomized as clusters 11 to parallel OSS `` arm A '' or control `` arm B '' .


Outpatient data on four malaria case management indicators were collected for 14 months .


Analysis compared changes before and during the interventions within arms ( relative risk = RR ) .


The effect of OSS was measured with the difference in changes across arms ( ratio of RR = RRR ) .


The proportion of patients with suspected malaria for whom a diagnostic test result for malaria was recorded decreased in arm B ( adjusted RR ( aRR ) = 0.97 ; 99 % CI : 0.82,1.14 ) during IMID , but increased 25 % in arm A ( aRR = 1.25 ; 99 % CI :0.94 , 1.65 ) during IMID and OSS relative to baseline ; ( aRRR = 1.28 ; 99 % CI :0.93 , 1.78 ) .


The estimated proportion of patients that received an appropriate antimalarial among those prescribed any antimalarial increased in arm B ( aRR = 1.09 ; 99 % CI : 0.87 , 1.36 ) and arm A ( aRR = 1.50 ; 99 % CI : 1.04 , 2.17 ) ; ( aRRR = 1.38 ; 99 % CI : 0.89 , 2.13 ) .


The proportion of patients with a negative diagnostic test result for malaria prescribed an antimalarial decreased in arm B ( aRR = 0.96 ; 99 % CI : 0.84 , 1.10 ) and arm A ( aRR = 0.67 ; 99 % CI : 0.46 , 0.97 ) ; ( aRRR = 0.70 ; 99 % CI : 0.48 , 1.00 ) .


The proportion of patients with a positive diagnostic test result for malaria prescribed an antibiotic did not change significantly in either arm .


The combination of IMID and OSS was associated with statistically significant improvements in malaria case management .


Controlling alloimmune humoral response is a challenge in transplantation .


Few studies have evaluated the impact of maintenance immunosuppression on blood humoral parameters .


We performed a post-hoc analysis on 307 kidney transplant recipients included in a prospective randomized trial comparing tacrolimus/mycophenolate mofetil ( Tac/MMF ) vs. cyclosporine/azathioprine ( CsA/AZA ) , both used with antithymocyte globulin induction and steroids .


Humoral parameters were analyzed at D0 , D15 , and M12 .


IgG , IgA , and IgM levels decreased significantly as soon as D15 in both groups ( 35 % , 26 % , and 35 % respectively , vs. D0 ) .


At M12 , although peripheral B-cell counts did not differ between the groups , Tac/MMF regimen was associated with lower IgG , IgA , and IgM levels than CsA/AZA ( 5.9 % , 14.6 % , and 34 % , respectively ) .


Hypogammaglobulinemia at D15 was not associated with an increased risk of infections during the first year .


The proportion of HLA-sensitized patients decreased in the Tac/MMF group ( 15.9 % at D0 and 6.7 % at M12 , p = 0.02 ) and remained stable in the CsA/AZA group ( 10.3 % at D0 and 8.9 % at M12 , p = 0.5 ) .


More patients sensitized at baseline became non-sensitized at M12 with Tac/MMF than with CsA/AZA .


Our results suggest humoral immunosuppression is better with Tac/MMF than with CsA/AZA during the first year of kidney transplantation .


Venous leg ulcers ( VLUs ) are a health problem in clinical care .


Several options can be employed as adjuvant to standard treatment .


We have aimed to analyze the effect of standard ulcer care alone with high-frequency ultrasound ( HFU ) and MIST ultrasound therapy on VLUs .


Ninety patients with VLUs were assigned into the standard treatment , HFU and MIST ultrasound groups .


All groups received the standard wound care .


In the ultrasound groups , HFU and MIST ultrasound therapy was administered to wounds 3 times per week until the wound healed .


Time of complete wound healing was recorded .


Wound size , pain , and edema were assessed at baseline and after 2 and 4 months .


Also , patients were instructed to contact our clinic monthly , and recurrence of VLUs was recorded for 6 months after complete wound healing .


The data was analyzed using a Student 's t-test , ANOVA , c2 , or Fisher 's exact test .


P < 0.05 was considered significant .


Mean time duration of complete wound healing in the first , second and third groups was 8.13 ( SD 1.40 ) , 6.10 ( SD 1.47 ) and 5.70 ( SD 1.57 ) months , respectively ( p < 0.0001 ) .


Size of ulcer , mean degree of pain and edema in ultrasound therapy was decreased after the 4-month visit in comparison to the standard-treatment group ( p = 0.01 , p < 0.0001 and p < 0.0001 , respectively ) .


Also , our results do n't show any significant differences between groups in the recurrence of VLUs during a 6-month follow up after complete wound healing ( p = 0.37 ) .


Our results in the present study show the significant effectiveness of ultrasound therapy in wound healing .


Differences between the two ultrasound therapy groups were not statistically significant .


To evaluate the efficacy and safety of intraarticular sprifermin ( recombinant human fibroblast growth factor 18 ) in the treatment of symptomatic knee osteoarthritis ( OA ) .


The study was a randomized , double-blind , placebo-controlled , proof-of-concept trial .


Intraarticular sprifermin was evaluated at doses of 10 g , 30 g , and 100 g.


The primary efficacy end point was change in central medial femorotibial compartment cartilage thickness at 6 months and 12 months as determined using quantitative magnetic resonance imaging ( qMRI ) .


The primary safety end points were nature , incidence , and severity of local and systemic treatment-emergent adverse events ( AEs ) and acute inflammatory reactions , as well as results of laboratory assessments .


Secondary end points included changes in total and compartment femorotibial cartilage thickness and volume as assessed by qMRI , changes in joint space width ( JSW ) seen on radiographs , and pain scores on the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) .


One hundred ninety-two patients were randomized and evaluated for safety , 180 completed the trial , and 168 were evaluated for the primary efficacy end point .


We found no statistically significant dose response in change in central medial femorotibial compartment cartilage thickness .


Sprifermin was associated with statistically significant , dose-dependent reductions in loss of total and lateral femorotibial cartilage thickness and volume and in JSW narrowing in the lateral femorotibial compartment .


All groups had improved WOMAC pain scores , with statistically significantly less improvement at 12 months in patients receiving the 100-g dose of sprifermin as compared with those receiving placebo .


There was no significant difference in serious AEs , treatment-emergent AEs , or acute inflammatory reactions between sprifermin and placebo groups .


No statistically significant relationship between treatment group and reduction in central medial femorotibial compartment cartilage thickness was observed ; however , prespecified structural secondary end points showed statistically significant dose-dependent reductions after sprifermin treatment .


Sprifermin was not associated with any local or systemic safety concerns .


The 2-adrenergic agonist dexmedetomidine is a sedative and can be used as an adjunct to anesthetics .


Our primary goal was thus to determine the extent to which dexmedetomidine reduces the requirement for propofol and remifentanil .


This double-blinded , randomized study ( NCT00921284 ) used an automated dual closed-loop administration to maintain the Bispectral Index between 40 and 60 .


Sixty-6 ASA physical status I and II patients were given either dexmedetomidine ( 1 g/kg over 10 minutes followed by a continuous infusion of 0.5 g/kg/h throughout surgery ) or comparable volumes of saline as a placebo .


Propofol and remifentanil requirements were compared using nonparametric tests and expressed as medians ( interquartile ranges ) .


Twenty-eight patients in each group completed the study .


Patients given dexmedetomidine required less propofol ( 1.0 [ 0.7-1 .3 ] vs 1.3 [ 1.0-1 .7 ] mg/kg , P = 0.002 ) and remifentanil ( 1.2 [ 1.0-1 .4 ] vs 1.6 [ 1.1-2 .8 ] g/kg , P = 0.02 ) for anesthetic induction .


The propofol dosage required for anesthetic maintenance was 29 % ( with a 95 % confidence interval , 18-40 ) lower in patients given dexmedetomidine ( 2.2 [ 1.5-3 .0 ] vs 3.1 [ 2.4-4 .5 ] mg/kg/h , P = 0.005 ) , whereas the remifentanil dosage was not significantly different ( 0.16 [ 0.09-0 .17 ] vs 0.14 [ 0.13-0 .21 ] g/kg/h with P = 0.3 ) .


The incidence of adverse events , including hemodynamic instability and delayed recovery , was comparable with and without dexmedetomidine .


The first postoperative request for morphine analgesia was delayed in patients given dexmedetomidine ( median fourth hour vs first hour , P = 0.008 ) .


Dexmedetomidine administration significantly reduced the requirement for both propofol and remifentanil during anesthetic induction and reduced propofol use during maintenance of anesthesia .


Dexmedetomidine also delayed postoperative analgesic use .


Dexmedetomidine is a useful adjuvant that reduces anesthetic requirement and provides postoperative analgesia .


Few randomised controlled trials ( RCTs ) of interventions for the treatment of adolescent obesity have taken place outside the western world .


This RCT tested whether a simple ` good practice ' intervention for the treatment of adolescent obesity would have a greater impact on weight status and other outcomes than a referral to primary care ( control ) in adolescents in Kuwait City .


We report on an assessor-blinded RCT of a treatment intervention in 82 obese 10 - to 14-year-olds ( mean age 12.4 , SD 1.2 years ) , randomised to a good practice treatment or primary care control group over 6 months .


The good practice intervention was intended as relatively low intensity ( 6 hours contact over 24 weeks , group-based ) , aiming to change sedentary behaviour , physical activity , and diet .


The primary outcome was a change in body mass index ( BMI ) Z score ; other outcomes were changes in waist circumference and blood pressure .


The retention of subjects to follow up was acceptable ( n = 31 from the intervention group , and n = 32 from the control group ) , but engagement with both the intervention and control treatment was poor .


Treatment had no significant effect on BMI Z score relative to control , and no other significant benefits to intervention were observed .


The trial was feasible , but highlights the need to engage obese adolescents and their families in the interventions being trialled .


The trial should inform the development of future adolescent obesity treatment trials in the Gulf States with the incorporation of qualitative assessment in future intervention trials .


RCT Registered as National Adolescent Treatment Trial for Obesity in Kuwait ( NATTO ) : http://www.controlled-trials.com/ISRCTN37457227 , 1 December 2009 .


Reflex cough is a defensive response generated in the brainstem in response to chemical and mechanical stimulation of the airways .


However , converging evidence shows that reflex cough is also influenced by central neural control processes .


In this study , we investigate whether reflex cough can be modulated by attentional focus on either external stimuli or internal cough-related stimuli .


Healthy volunteers ( N = 24 ; seven men ; age range , 18-25 years ) completed four blocks of citric acid-induced cough challenges while , simultaneously , auditory stimuli were presented .


Within each block , four concentrations were administered ( 30 , 100 , 300 and 1,000 mM , randomized ) .


During two subsequent blocks , participants focused their attention externally ( counting tones ) .


During the other two blocks , participants focused their attention internally ( counting coughs ) .


The order of attentional focus was counterbalanced across participants .


Ratings of the urge to cough were collected after each challenge .


Cough frequency was determined by audio recording .


Cough frequency was higher when participants focused their attention internally vs externally ( P < .05 ) .


Also urge to cough was greater during internal vs external focus ( P < .05 ) , but the effect was smaller in later blocks of trials .


Reflex cough can be modulated by attentional focus .


Internally focused attention may be a mechanism involved in excessive ( idiopathic ) cough , while an external focus may be introduced as part of treatments targeting excessive cough .


Subcutaneous APF530 provides controlled sustained release of granisetron to prevent acute ( 0-24 h ) and delayed ( 24-120 h ) chemotherapy-induced nausea and vomiting ( CINV ) .


This randomized , double-blind phase 3 trial compared APF530 and palonosetron in preventing acute and delayed CINV after moderately ( MEC ) or highly emetogenic chemotherapy ( HEC ) .


Patients receiving single-day MEC or HEC received single-dose APF530 250 or 500 mg subcutaneously ( SC ) ( granisetron 5 or 10 mg ) or intravenous palonosetron 0.25 mg .


Primary objectives were to establish APF530 noninferiority to palonosetron for preventing acute CINV following MEC or HEC and delayed CINV following MEC and to determine APF530 superiority to palonosetron for preventing delayed CINV following HEC .


The primary efficacy end point was complete response ( CR [ using CI difference for APF530-palonosetron ] ) .


A lower confidence bound greater than -15 % indicated noninferiority .


In the modified intent-to-treat population ( MEC = 634 ; HEC = 707 ) , both APF530 doses were noninferior to palonosetron in preventing acute CINV after MEC ( CRs 74.8 % [ -9.8 , 9.3 ] and 76.9 % [ -7.5 , 11.4 ] , respectively , vs. 75.0 % palonosetron ) and after HEC ( CRs 77.7 % [ -11.5 , 5.5 ] and 81.3 % [ -7.7 , 8.7 ] , respectively , vs. 80.7 % palonosetron ) .


APF530 500 mg was noninferior to palonosetron in preventing delayed CINV after MEC ( CR 58.5 % [ -9.5 , 12.1 ] vs. 57.2 % palonosetron ) but not superior in preventing delayed CINV after HEC .


Adverse events were generally mild and unrelated to treatment , the most common ( excluding injection-site reactions ) being constipation .


A single subcutaneous APF530 injection offers a convenient alternative to palonosetron for preventing acute and delayed CINV after MEC or HEC .


Patients with psychiatric illness have increased somatic morbidity and increased mortality .


Knowledge of how to integrate the prevention and care of somatic illness into the treatment of psychiatric patients is required .


The aims of this study were to investigate whether an intervention programme to improve physical health is effective .


An extension of the European Network for Promoting the Health of Residents in Psychiatric and Social Care Institutions ( HELPS ) project further developed as a 12-month controlled cluster-randomized intervention study in the Danish centre .


Waist circumference was a proxy of unhealthy body fat in view of the increased risk of cardiovascular diseases and type 2 diabetes .


Waist circumference was 108 cm for men and 108 cm for women .


Controlled for cluster randomization , sex , age , and body fat , the intervention group showed a small , but not significant , reduction in waist circumference , while participants in the control group showed a significant increase in waist circumference .


The intervention had a positive effect on the physical health of the patients measured by a reduction in the increase of waist circumference .


In resource-constrained settings of developing countries , promotion of community-based health interventions through community health workers ( CHWs ) is an important strategy to improve child health .


However , there are concerns about the sustainability of such programmes owing to the high rate of CHW attrition .


This study examined factors influencing retention of volunteer CHWs in a cluster randomised trial on community management of under-5 fever in a rural Ghanaian district .


Data were obtained from structured interviews ( n = 520 ) and focus group discussions ( n = 5 ) with CHWs .


Factors influencing CHWs ' decisions to remain or leave the programme were analysed using a probit model , and focus group discussion results were used to elucidate the findings .


The attrition rate among CHWs was 21.2 % .


Attrition was comparatively higher in younger age groups ( 25.9 % in 15-25 years group , 18.2 % in 26-45 years group and 16.5 % in 46 years group ) .


Approval of a CHW by the community ( p < 0.001 ) and the CHW 's immediate family ( p < 0.05 ) were significant in influencing the probability of remaining in the programme .


Motivation for retention was related to the desire to serve their communities as well as humanitarian and religious reasons .


The relatively moderate rate of attrition could be attributed to the high level of community involvement in the selection process as well as other aspects of the intervention leading to high community approval and support .


Attention for these aspects could help improve CHW retention in community-based health interventions in Ghana , and the lessons could be applied to countries within similar settings .


Short-term studies have suggested beneficial effects of a Palaeolithic-type diet ( PD ) on body weight and metabolic balance .


We now report the long-term effects of a PD on anthropometric measurements and metabolic balance in obese postmenopausal women , in comparison with a diet according to the Nordic Nutrition Recommendations ( NNR ) .


Seventy obese postmenopausal women ( mean age 60 years , body mass index 33 kg/m ( 2 ) ) were assigned to an ad libitum PD or NNR diet in a 2-year randomized controlled trial .


The primary outcome was change in fat mass as measured by dual-energy X-ray absorptiometry .


Both groups significantly decreased total fat mass at 6 months ( -6.5 and-2 .6 kg ) and 24 months ( -4.6 and-2 .9 kg ) , with a more pronounced fat loss in the PD group at 6 months ( P < 0.001 ) but not at 24 months ( P = 0.095 ) .


Waist circumference and sagittal diameter also decreased in both the groups , with a more pronounced decrease in the PD group at 6 months ( -11.1 vs-5 .8 cm , P = 0.001 and-3 .7 vs-2 .0 cm , P < 0.001 , respectively ) .


Triglyceride levels decreased significantly more at 6 and 24 months in the PD group than in the NNR group ( P < 0.001 and P = 0.004 ) .


Nitrogen excretion did not differ between the groups .


A PD has greater beneficial effects vs an NNR diet regarding fat mass , abdominal obesity and triglyceride levels in obese postmenopausal women ; effects not sustained for anthropometric measurements at 24 months .


Adherence to protein intake was poor in the PD group .


The long-term consequences of these changes remain to be studied .


To investigate whether an infancy-onset , low saturated fat-oriented dietary intervention influences serum adiponectin concentration in adolescents , and to study the association of adiponectin with subclinical markers of vascular health , and cardio-metabolic risk factors .


The longitudinal , randomized Special Turku Coronary Risk Factor Intervention Project aimed to modify child 's dietary fat quality replacing saturated fat with unsaturated fat .


Serum adiponectin ( n = 521 ) along with weight , height , high-density lipoprotein cholesterol , C-reactive protein ( CRP ) , triglycerides , and insulin were measured at age 15 years .


Adiposity was assessed using body mass index , waist circumference , and abdominal fat thickness measured with ultrasound .


Metabolic syndrome was defined according to International Diabetes Foundation criteria .


Vascular ultrasound measures including carotid intima-media thickness ( IMT ) were assessed .


Adiponectin concentrations were similar in the intervention and control groups ( P = .16 ) .


Adiponectin associated with carotid IMT ( r = -0.13 , P = .005 ) , high-density lipoprotein cholesterol ( r = 0.18 , P < .0001 ) , triglycerides ( r = -0.16 , P = .0004 ) , CRP ( r = -0.10 , P = .02 ) , insulin ( r = -0.14 , P = .002 ) , and adiposity ( r = -0.18 -0.24 , P .0001 ) .


When adjusted for adiposity indices , the association with carotid IMT was only marginally diluted ( P = .03 -.06 ) , but the associations with insulin and CRP became nonsignificant .


Adolescents with adiponectin median had 4-fold risk of metabolic syndrome than peers with adiponectin > median ( CI 1.8-10 .2 , P = .0001 ) .


In healthy adolescents , low serum adiponectin is related with carotid IMT and metabolic syndrome .


We found no evidence that repeated low saturated fat-oriented dietary counseling would influence serum adiponectin in adolescence .


Registered with ClinicalTrials.gov : NCT00223600 .


Alcohol dependence is common in bipolar disorder ( BPD ) and associated with treatment nonadherence , violence , and hospitalization .


Quetiapine is a standard treatment for BPD .


We previously reported improvement in depressive symptoms , but not alcohol use , with quetiapine in BPD and alcohol dependence .


However , mean alcohol use was low and a larger effect size on alcohol-related measures was observed in those with higher levels of alcohol consumption .


In this study , efficacy of quetiapine in patients with BPD and alcohol dependence was examined in patients with higher mean baseline alcohol use than in the prior study .


Ninety outpatients with bipolar I or II disorders , depressed or mixed mood state , and current alcohol dependence were randomized to 12 weeks of sustained release quetiapine ( to 600 mg/d ) add-on therapy or placebo .


Drinking was quantified using the Timeline Follow Back method .


Additional assessment tools included the Hamilton Rating Scale for Depression , Inventory of Depressive Symptomatology-Self-Report , Young Mania Rating Scale , Penn Alcohol Craving Scale , liver enzymes , and side effects .


Alcohol use and mood were analyzed using a declining-effects random-regression model .


Baseline and demographic characteristics in the 2 groups were similar .


No significant between-group differences were observed on the primary outcome measure of drinks per day or other alcohol-related or mood measures ( p > 0.05 ) .


Overall side effect burden , glucose , and cholesterol were similar in the 2 groups .


However , a significant weight increase was observed with quetiapine at week 6 ( +2.9 lbs [ SE 1.4 ] quetiapine vs. -2.0 lbs [ SE 1.4 ] , p = 0.03 ) , but not at week 12 .


Scores on the Barnes Akathisia Scale increased significantly more ( p = 0.04 ) with quetiapine ( +0.40 [ SE 0.3 ] ) than placebo ( -0.52 [ SE 0.3 ] ) at week 6 but not week 12 .


Retention ( survival ) in the study was similar in the groups .


Findings suggest that quetiapine does not reduce alcohol consumption in patients with BPD and alcohol dependence .


To assess the longitudinal curative effect and improvement of subjective symptoms by using intratympanic injection of Budesonide ( BUD ) for otitis media with effusion ( OME ) patients older than 12 years and adults .


A single-blind , randomized , parallel-controlled prospective study .


Hospital , outpatient .


Ninety patients ( 112 ears ) who were diagnosed as having OME were recruited and then randomized to BUD , dexamethasone ( DEX ) , and sodium chloride ( NS ) groups , the latter two served as controls .


The randomly allocated patients received intratympanic injection of BUD ( 0.5 mg/1 ml ) , DEX ( 2 mg/1 ml ) , or 0.9 % NS solution ( 1 ml ) once a week .


Survival analysis was applied to compare the longitudinal curative effects among the 3 groups .


Meanwhile , the 6 main subjective symptoms were scored by 10-point visual scale , and physician 's evaluations were preformed during treatment and follow-up .


After adjustment for course of disease , volume , and characters of effusion , the relative risk ( RR ) of BUD is 0.139 ( 95 % CI , 0.054-0 .358 ) when compared with NS .


Survival curve demonstrated that the rank of longitudinal therapeutic efficacy was BUD , DEX , and NS ( p < 0.05 ) .


Both BUD and DEX showed improvements in subjective symptoms and quality of life compared with NS ( p < 0.05 ) .


In the aspect of improving the symptom of stuffy ear , BUD showed advantage over both DEX and NS .


During and after treatment , no serious complications or sequelae were observed .


Intratympanic injection with BUD for OME patients showed advantages in improving long-term therapeutic efficacy , it was a safe and effective intervention for adolescents and adults with OME .


To determine the nutrition risk status and factors associated with nutrition risk among older adults enrolled in the Brief Risk Identification Geriatric Health Tool ( BRIGHT Trial ) .


A cluster randomised controlled trial .


Three main centres in New Zealand .


A total of 3,893 older adults were recruited from 60 general practices in three of the District Health Board ( DHB ) regions aged 75 years and older ( or 65 years and older if Mori ) .


Nutrition risk was assessed using the Australian Nutrition Screening Initiative ( ANSI ) .


Validated questionnaires were used to establish quality of life ( WHOQOL-BREF ) , physical function ( the Nottingham Extended Activities of Daily Living ) and depressive symptoms ( 15 item Geriatric Depression Scale ) .


Demographic , standard of living and health data were established .


Sixty two percent of participants were identified to be at moderate or high nutrition risk .


The mean ANSI score was 4.9 ( range 0-21 , maximum 29 ) .


Factors which independently predicted moderate or high nutrition risk were female gender , being Mori and other ethnicities versus European , not being married , taking multiple medications , having more depressive symptoms , cardiovascular disease and diabetes .


Protective factors independently related to low nutrition risk were living with others , higher physical and social health related QOL and higher functional status .


WHOQOL environmental and psychological factors were not associated with nutrition risk when other predictive factors were taken into account .


Nearly two thirds of participants were identified to be at higher nutrition risk .


Women , living alone , taking multiple medications , with depressive symptoms , cardiovascular disease and ndiabetes were factors associated with higher nutrition risk .


Those at low nutrition risk had a better functional status and physical and social health related QOL .


Computer-tailored physical activity ( PA ) interventions delivered through the Internet represent a promising and appealing method to promote PA at a population level .


However , personalized advice is mostly provided based on subjectively measured PA , which is not very accurate and might result in the delivery of advice that is not credible or effective .


Therefore , an innovative computer-tailored PA advice was developed , based on objectively pedometer-measured PA. .


The study aim was to evaluate the effectiveness of a computer-tailored , pedometer-based PA intervention in working adults .


Participants ( 18 years ) were recruited between May and December 2012 from eight Flemish workplaces .


These workplaces were allocated randomly to an intervention or control group .


Intervention group participants ( n = 137 ) received ( 1 ) a booklet with information on how to increase their steps , ( 2 ) a non-blinded pedometer , and ( 3 ) an Internet link to request computer-tailored step advice .


Control group participants ( n = 137 ) did not receive any of the intervention components .


Self-reported and pedometer-based PA were assessed at baseline ( T0 ) , and 1 month ( T1 ) and 3 months ( T2 ) months post baseline .


Repeated measures analyses of covariance were used to examine intervention effects for both the total sample and the at-risk sample ( ie , adults not reaching 10,000 steps a day at baseline ) .


The recruitment process resulted in 274 respondents ( response rate of 15.1 % ) who agreed to participate , of whom 190 ( 69.3 % ) belonged to the at-risk sample .


Between T0 and T1 ( 1-month post baseline ) , significant intervention effects were found for participants ' daily step counts in both the total sample ( P = .004 ) and the at-risk sample ( P = .001 ) .


In the at-risk sample , the intervention effects showed a daily step count increase of 1056 steps in the intervention group , compared to a decrease of 258 steps in the control group .


Comparison of participants ' self-reported PA revealed a significant intervention effect for time spent walking in the at-risk sample ( P = .02 ) .


Intervention effects were still significant 3 months post baseline for participants ' daily step counts in both the total sample ( P = .03 ) and the at-risk sample ( P = .02 ) ; however , self-reported PA differences were no longer significant .


A computer-tailored , pedometer-based PA intervention was effective in increasing both pedometer-based and self-reported PA levels , mainly in the at-risk participants .


However , more effort should be devoted to recruit and retain participants in order to improve the public health impact of the intervention .


ClinicalTrials.gov : NCT02080585 ; https://clinicaltrials.gov/ct2/show/NCT02080585 ( Archived by WebCite at http://www.webcitation.org/6VvQnRQSy ) .


In a multicenter , randomized , open-label phase III study , patients 65 years with newly diagnosed AML received decitabine 20 mg/m ( 2 ) once daily for 5 days every 4 weeks ( n = 242 ) or treatment choice ( supportive care or cytarabine 20 mg/m ( 2 ) once daily for 10 days every 4 weeks ; n = 243 ) .


Decitabine use demonstrated greater response rates ( P = .001 ) and OS data favored decitabine .


In a post hoc sensitivity analysis of mature data of patients in the intent-to-treat population ( N = 485 ) , OS at 3 , 6 , 12 , 18 , and 24 months after randomization was estimated for each arm using Kaplan-Meier methods .


Age , cytogenetic risk , and Eastern Cooperative Oncology Group performance status were used as stratification factors in the Cox regression model to estimate the hazard ratio .


A survival advantage was seen with decitabine at each cutoff time point ; hazard ratios for OS for decitabine vs. treatment choice were 0.83 , 0.71 , 0.83 , 0.80 , and 0.79 at 3 , 6 , 12 , 18 , and 24 months , respectively .


A trend toward improved OS with decitabine was observed at fixed time points over 2 years .


Decitabine should be considered as a treatment option for older patients with AML and poor prognostic risk factors .


The aim of this study was to compare the time to initial alignment and extraction space closure using conventional brackets and active and passive self-ligating brackets .


One hundred adolescent patients 11 to 18 years of age undergoing maxillary and mandibular fixed appliance therapy after the extraction of 4 premolars were randomized with stratification of 2 age ranges ( 11-14 and 15-18 years ) and 3 maxillomandibular plane angles ( high , medium , and low ) with an allocation ratio of 1:2:2 .


Restrictions were applied using a block size of 10 .


Allocation was to 1 of 3 treatment groups : conventional brackets , active self-ligating , or passive self-ligating brackets .


All subjects were treated with the same archwire sequence and space-closing mechanics in a district general hospital setting .


The trial was a 3-arm parallel design .


Labial-segment alignment and space closure were measured on study models taken every 12 weeks throughout treatment .


All measurements were made by 1 operator who was blinded to bracket type .


The patients and other operators were not blinded to bracket type during treatment .


Ninety-eight patients were followed to completion of treatment ( conventional , n = 20 ; active self-ligating brackets , n = 37 ; passive self-ligating brackets , n = 41 ) .


The data were analyzed using linear mixed models and demonstrated a significant effect of bracket type on the time to initial alignment ( P = 0.001 ) , which was shorter with the conventional brackets than either of the self-ligating brackets .


Sidak 's adjustment showed no significant difference in effect size ( the difference in average response in millimeters ) between the active and passive self-ligating brackets ( the results are presented as effect size , 95 % confidence intervals , probabilities , and intraclass correlation coefficients ) ( -0.42 [ -1.32 , 0.48 ] , 0.600 , 0.15 ) , but the conventional bracket was significantly different from both of these ( -1.98 [ -3.19 , -0.76 ] , 0.001 , 0.15 ; and -1.56 [ -2.79 , -0.32 ] , 0.001 , 0.15 ) .


There was no statistically significant difference between any of the 3 bracket types with respect to space closure .


Space-closure times were shorter in the mandible , except for the Damon 3MX bracket ( Ormco , Orange , Calif ) , where active and total space-closure times were shorter in the maxilla .


No adverse events were recorded in the trial .


Time to initial alignment was significantly shorter for the conventional bracket than for either the active or passive self-ligating brackets .


There was no statistically significant difference in passive , active , or total space-closure times among the 3 brackets under investigation .


To date there has been no research investigating moderators of response to micronutrient treatment of mental illness , specifically baseline nutrient levels .


We conducted analyses of data from a randomized placebo-controlled trial ( RCT ) of 80 adults ( 16years ) with Attention-Deficit/Hyperactivity Disorder ( ADHD ) , whereby participants were treated acutely ( 8weeks ) with micronutrients or placebo followed by an open-label ( OL ) phase of 8weeks whereby all participants received micronutrients .


To ensure that all participants had been exposed to the micronutrients for 8weeks , only those 64 who had adhered to the treatment protocol and completed 8weeks on nutrients were included in the data analysis : 34 from the group that had been randomized to the micronutrient arm , and 30 from the group that had been randomized to the placebo group and hence had only received nutrients in the OL phase .


Six outcomes were examined : change in ADHD symptoms ( self/clinician ) , ADHD responder , Clinical Global Impression-Improvement ( CGI-I ) , change in mood , and change in Global Assessment of Functioning ( GAF ) .


Demographic , developmental and psychiatric history , current clinical characteristics , and baseline nutrient levels were all considered as putative predictors .


There were significant changes in all outcome variables after 8weeks exposure to the micronutrients .


Among the nutrients recorded at baseline , substantial deficiencies ( 27 % ) were only observed for vitamin D. However , other than an association showing that higher iron at baseline was correlated with higher baseline depression scores , baseline nutrient levels were not correlated with baseline psychiatric variables/current clinical characteristics .


Regression analyses revealed that higher baseline ferritin and lower baseline copper and vitamin D levels were associated with a better response to treatment for some but not all outcomes .


None of the other nutrient levels was found to be associated with outcome , including zinc , vitamin B12 , iron , and folate .


There were no childhood risk factors , demographic variables or clinical correlates that contraindicated micronutrient treatment ; more severe symptoms at baseline and greater number of developmental risk factors predicted greater treatment response .


Further research looking at nutrients more broadly is required to confirm these initial observations about ferritin , vitamin D and copper ; however , the results suggest that serum nutrient levels have limited value for identifying who will respond to treatment .


To explore the feasibility and safety of enteral nutrition in preoperative bowel preparation for rectal cancer patients undergoing radical operation .


Sixty rectal cancer patients undergoing selective low anterior resection were randomized into the trial group ( n = 30 ) and the control group ( n = 30 ) .


Patients in the trial group received clean liquid integral protein diet for 3 days before operation without mechanical bowel preparation .


Patients in the control group received traditional diet and mechanical bowel preparation .


The intraoperative and postoperative clinical data , the quality of bowel preparation , postoperative complications , and nutritional parameters were compared between the two groups .


There were no significant differences in clinicopathological characteristics between the two groups before operation .


The operative time , blood loss , quality of bowel preparation as well as postoperative hospital stay were not significantly different ( all P > 0.05 ) .


While the time to first flatus [ ( 2.530.91 ) d vs. ( 3.030.68 ) d ] and semi-liquid diet intake [ ( 3.950.83 ) d vs. ( 4.521.14 ) d ] were significantly shorter in the trial group as compared with the control group ( all P < 0.05 ) .


There were no death and no significant difference in postoperative complications [ 16.7 % ( 5/30 ) vs. 20.0 % ( 6/30 ) , P > 0.05 ] .


The levels of postoperative total protein , albumin , and prealbumin decreased significantly .


Meanwhile , the levels of postoperative albumin [ ( 36.22.5 ) g/L vs. ( 33.52.6 ) g/L , P < 0.01 ] and prealbumin [ ( 325.428.2 ) mg/L vs. ( 302.534.2 ) mg/L , P < 0.01 ] in the trial group were significantly higher than those in the control group .


Preoperative enteral nutrition can replace the mechanical bowel preparation with better efficacy , and improve the postoperative nutritional status without increasing surgical risk in rectal cancer patients undergoing radical operation .


In resource-poor areas of China and India , the cardiovascular disease burden is high , but availability of and access to quality healthcare is limited .


Establishing a management scheme that utilizes the local infrastructure and builds healthcare capacity is essential for cardiovascular disease prevention and management .


The study aims to develop , implement , and evaluate the feasibility and effectiveness of a simplified , evidence-based cardiovascular management program delivered by community healthcare workers in resource-constrained areas in Tibet , China and Haryana , India .


This yearlong cluster-randomized controlled trial will be conducted in 20 villages in Tibet and 20 villages in Haryana .


Randomization of villages to usual care or intervention will be stratified by country .


High cardiovascular disease risk individuals ( aged 40 years or older , history of heart disease , stroke , diabetes , or measured systolic blood pressure of 160 mmHg or higher ) will be screened at baseline .


Community health workers in the intervention villages will be trained to manage and follow up high-risk patients on a monthly basis following a simplified ' 2 +2 ' intervention model involving two lifestyle recommendations and the appropriate prescription of two medications .


A customized electronic decision support system based on the intervention strategy will be developed to assist the community health workers with patient management .


Baseline and follow-up surveys will be conducted in a standardized fashion in all villages .


The primary outcome will be the net difference between-group in the proportion of high-risk patients taking antihypertensive medication pre - and post-intervention .


Secondary outcomes will include the proportion of patients taking aspirin and changes in blood pressure .


Process and economic evaluations will also be conducted .


To our knowledge , this will be the first study to evaluate the effect of a simplified management program delivered by community health workers with the help of electronic decision support system on improving the health of high cardiovascular disease risk patients .


If effective , this intervention strategy can serve as a model that can be implemented , where applicable , in rural China , India , and other resource-constrained areas .


The trial was registered in the clinicaltrials.gov database on 30 December , 2011 and the registration number is NCT01503814 .


The purpose of this study was to evaluate the effectiveness of the academic asthma education and counseling Staying Healthy-Asthma Responsible and Prepared ( SHARP ) program on fostering psychosocial acceptance of asthma .


This was a phase III , two-group , cluster-randomized , single-blinded , longitudinal study .


Students from grades 4 and 5 ( N = 205 ) with asthma and their caregivers completed surveys at pre-intervention and at 1 - , 12 - , and 24-months post-intervention .


Analysis involved multilevel modeling .


All students demonstrated significant improvement in aspects of acceptance ; students in SHARP demonstrated significant improvement in openness to sharing and connectedness with teachers over students in the control condition .


The SHARP program offers a well-tested , effective program for psychosocial acceptance of asthma , which is welcomed by schools .


Posterior sagittal anorectoplasty ( PSARP ) has become the standard surgical treatment for males rectourethral fistula ( RUF ) at most surgical centers worldwide .


We aimed to define the long-term bowel functional outcomes following PSARP for RUF at our institution between 1983 and 2006 , with comparison to age - and gender-matched controls .


Patients were invited to answer a detailed , previously validated Bowel Function Score ( BFS ) questionnaire by post .


Respondents were matched by age and gender to three controls from the general population who had answered identical questionnaires .


Case records were reviewed retrospectively for operative details .


Ethical approval was obtained .


Social continence was defined as soiling or fecal accidents < 1/week and no requirement for changes of underwear or protective aids .


Of 34 ( 79 % ) respondents ( median age 19 ( range , 4-29 ) years ) , 74 % had voluntary bowel movements ( VBMs ) , 24 % were reliant on anterograde continence enema ( ACE ) washouts , and 1 patient had a colostomy .


Impairment of bowel function was significantly higher in all aspects of fecal control among patients than controls ( p < 0.001 ) .


A statistically significant decline in fecal accidents and soiling was observed with age ( p 0.03 ) .


Thirty-one percent of patients with VBMs had constipation managed with diet or laxatives ( vs 2 % of controls , p = 0.0002 ) .


Of patients with VBMs followed up for > 12 years ( n = 20 ) , 50 % were completely continent ( vs 73 % of controls ; p = NS ) .


Overall , 76 % of respondents were socially continent with or without artificial means in the form of ACE washouts .


By BFS score , 39 % had a good functional outcome , 27 % had a moderate outcome , 9 % had a clearly poor score and 24 % were living with an ACE .


Our results suggest that in the long-term , functional symptoms remain highly prevalent among patients treated for RUF with PSARP .


However , the majority can be expected to achieve social continence , although for some this will require intervention with ACE bowel management .


Approximately one third may report VBMs and complete continence .


To test the feasibility , acceptability and initial effectiveness of a text message-based aftercare treatment programme among alcohol outpatients .


Clients treated for alcohol use disorders from three Swiss outpatient alcohol treatment centres were invited by their counsellors to participate in a study testing an interactive aftercare programme employing the use of text messages and personal phone calls .


Fifty study participants were randomly assigned to either the 6-month aftercare programme ( n = 25 ) or treatment as usual ( n = 25 ) .


The intervention consisted of ( a ) monitoring of self-selected drinking goals at regular intervals , ( b ) motivational text messages to stick to self-selected drinking goals and ( c ) proactive telephone calls from counsellors when participants neglected to stick to their drinking goals or expressed a need for support .


Follow-up interviews were conducted 6 months after randomization .


Throughout the programme , participants received a total of 421 text message prompts .


Out of these , participants provided valid replies to 371 ( 88.1 % ) within 48 h. Out of the 25 participants in the intervention group , 11 ( 44.0 % ) sent at least one call-for-help reply .


Based on complete case data , at risk alcohol use at follow-up was 41.7 % in the control group and 28.6 % in the intervention group ( OR = 0.56 , 95 % CI = 0.16-1 .95 , P = 0.36 ) .


The interactive low-intensive aftercare programme was well accepted by the participants .


Testing its efficacy within an adequately powered randomized controlled trial might be reasonable .


Weaning is typically regarded as a process of discontinuing mechanical ventilation in the daily practice of an intensive care unit ( ICU ) .


Among the ICU patients , 39 % -40 % need mechanical ventilator for sustaining their lives .


The predictive rate of successful weaning achieved only 35-60 % for decisions made by physicians .


Clinical decision support systems ( CDSSs ) are promising in enhancing diagnostic performance and improve healthcare quality in clinical setting .


To our knowledge , a prospective study has never been conducted to verify the effectiveness of the CDSS in ventilator weaning before .


In this study , the CDSS capable of predicting weaning outcome and reducing duration of ventilator support for patients has been verified .


A total of 380 patients admitted to the respiratory care center of the hospital were randomly assigned to either control or study group .


In the control group , patients were weaned with traditional weaning method , while in the study group , patients were weaned with CDSS monitored by physicians .


After excluding the patients who transferred to other hospitals , refused further treatments , or expired the admission period , data of 168 and 144 patients in the study and control groups , respectively , were used for analysis .


The results show that a sensitivity of 87.7 % has been achieved , which is significantly higher ( p < 0.01 ) than the weaning determined by physicians ( sensitivity : 61.4 % ) .


Furthermore , the days using mechanical ventilator for the study group ( 38.41 3.35 ) is significantly ( p < 0.001 ) shorter than the control group ( 43.69 14.89 ) , with a decrease of 5.2 days in average , resulting in a saving of healthcare cost of NT$ 45,000 ( US$ 1,500 ) per patient in the current Taiwanese National Health Insurance setting .


The CDSS is demonstrated to be effective in identifying the earliest time of ventilator weaning for patients to resume and sustain spontaneous breathing , thereby avoiding unnecessary prolonged ventilator use and decreasing healthcare cost .


Subjective tinnitus is the perception of sound in the absence of a corresponding external sound for which there is no known medical etiology .


For a minority of individuals with tinnitus , the condition impacts their ability to lead a normal lifestyle and is severely debilitating .


There is no known cure for tinnitus , so current therapy focuses on reducing the effect of tinnitus on the patient 's quality of life .


Tinnitus retraining therapy ( TRT ) uses nonpsychiatric tinnitus-specific educational counseling and sound therapy in a habituation-based protocol to reduce the patient 's tinnitus-evoked negative reaction to , and awareness of , the tinnitus , with the ultimate goal of reducing the tinnitus impact on the patient 's quality of life .


Some studies support the efficacy of TRT , but no trial to date has compared TRT with the current standard of care or evaluated the separate contributions of TRT counseling and sound therapy .


The Tinnitus Retraining Therapy Trial ( TRTT ) is a randomized , double-blind , placebo-controlled , multicenter trial for individuals with intolerable tinnitus .


The TRTT is enrolling active-duty and retired military personnel and their dependents with functionally adequate hearing sensitivity and severe tinnitus at US Air Force , Navy , and Army medical centers .


Eligible study participants are randomized to TRT , partial TRT , or standard care to determine the efficacy of TRT and its components ( TRT counseling and sound therapy ) .


The primary outcome is change in score on the Tinnitus Questionnaire assessed longitudinally between baseline and follow-up ( 3 , 6 , 12 , and 18 months following treatment ) .


Secondary outcomes include subscale score changes in the Tinnitus Questionnaire , overall and subscale score changes in the Tinnitus Functional Index and Tinnitus Handicap Inventory , and change in the visual analog scale of the TRT Interview Form .


Audiological outcomes include tinnitus pitch and loudness match and measures of loudness discomfort levels .


The incidence of depression as a safety measure is assessed at each visit using the Beck Depression Inventory Fast Screen .


Clinicaltrials.gov NCT01177137 .


Treadmill training with partial body weight support has been suggested as a useful strategy for gait rehabilitation after stroke .


This prospective , randomized , controlled study of gait training tested the feasibility and potential efficacy of using a robotic-assisted gait device , Lokomat , for treadmill training with partial body weight support in subjects with chronic hemiplegia ; the device was also compared with conventional home exercise .


Twenty-two male ambulatory ischemic or hemorrhagic induced stroke patients with chronic hemiplegia lasting at least 12 months were enrolled in this prospective study .


The patients were assigned to either the Lokomat group or the conventional exercise group .


The Lokomat group underwent active robotic training for ten sessions ( five sessions per week for two weeks ) .


Each session lasted 30 minutes .


If a patient missed three consecutive training sessions , he was removed from the study .


The Timed Up and Go Test is used to assess mobility and requires both static and dynamic balance .


The 10-m Timed Walking Speed Test is designed to determine the patient 's overground walking speed .


The Mini-Mental State Examination and Hospital Anxiety and Depression Scale were used for mental and psychological evaluation ; the Functional Ambulation Categories was used to assess ambulatory status .


Within each eight-week interval , the patients undergoing the Lokomat training demonstrated significantly greater improvement on the Timed Up and Go Test and 10-m Timed Walking Speed Test than those undergoing conventional training .


Despite the small number of patients in the study , the present data suggests that the robotic-assisted device , Lokomat , provides innovative possibilities for gait training in chronic hemiplegia rehabilitation by training at higher intensity levels for longer durations than traditional home exercise .


Patients with cardiac arrhythmias are generally instructed to avoid caffeine intake .


A comprehensive evaluation of the electrophysiological effects of caffeine on atrial and ventricular tissues in humans has not previously been performed .


Eighty patients ( 31men , mean age 4914years ) with symptomatic supraventricular tachycardia ( SVT ) undergoing an electrophysiologic study ( EPS ) prior to catheter ablation were randomized to receive oral caffeine or placebo .


Caffeine at a dosage of 5mg/kg ( moderate intake ) or placebo tablets were administered orally at a mean time of 5713 minutes prior to the EPS .


The median ( IQR ) caffeine level in patients receiving caffeine was 7.4 g/mL ( 4.7-8 .7 ) , as compared with 0.15 ( 0.00-0 .61 ) in patients receiving placebo , P < 0.0001 .


Caffeine was associated with a significant increase in resting systolic and diastolic blood pressures as compared with placebo , while the resting heart rate was not significantly different between both groups .


Caffeine was not associated with significant effects on the effective refractory period of the atrium or ventricle , as well as on AV node conduction .


SVT was induced in all but 3 patients ; there was no significant difference between groups receiving placebo or caffeine on SVT inducibility or the cycle length of induced tachycardias .


Caffeine , at moderate intake , was associated with significant increases in systolic and diastolic blood pressures , but had no evidence of a significant effect on cardiac conduction and refractoriness .


Furthermore , no effect of caffeine on SVT induction or more rapid rates of induced tachycardias was found .


Bipolar disorder often co-occurs with anxiety disorders .


Evidence suggests that second-generation antipsychotics ( SGAs ) may be useful in treating both conditions .


This study examined the efficacy of ziprasidone in the treatment of these disorders .


This 3-site , randomized , double-blind , placebo-controlled , parallel group , 8-week trial of ziprasidone monotherapy examined 49 subjects with bipolar disorder and lifetime panic disorder ( with or without agoraphobia ) or generalized anxiety disorder ( GAD ) experiencing moderately severe anxiety symptoms at entrance into the study .


Both bipolar disorder and anxiety diagnoses were based on DSM-IV-TR criteria .


Patients were screened and randomized from June 25 , 2010 , through August 23 , 2011 .


Primary outcome measures were the Clinical Global Impressions-21 Anxiety Scale ( CGI-21 Anxiety ) and the Sheehan Disability Scale ( SDS ) , with secondary measures monitoring anxiety and mood symptoms .


Last-observation-carried-forward analyses demonstrated that patients in the ziprasidone group did not improve significantly more than those in the placebo group on the CGI-21 Anxiety ( F1 = 0.34 ; P = .564 ) or SDS ( F1 = 0.26 ; P = .611 ) .


Secondary analysis using hierarchical linear modeling found similar results ( CGI-21 Anxiety : F1 = 1.82 ; P = .178 ; and SDS : F1 = 0.70 ; P = .408 ) .


Regardless of group , time in the study was associated with significant decrease in anxiety ( F1 = 11.08 ; P = .001 ) and total disability ( F1 = 26.16 ; P < .001 ) .


Patients in the ziprasidone group showed a greater increase in abnormal involuntary movement , and 81.8 % ( n = 9 ) of the subjects who withdrew from the study due to adverse events , serious adverse events , or side effects were in the ziprasidone group .


Results suggest that ziprasidone monotherapy was not associated with a clinically significant improvement in anxiety symptoms or improved function for patients with bipolar disorder , lifetime panic disorder or GAD , and concurrent moderately severe anxiety symptoms , and it was associated with a more negative side-effect profile relative to placebo .


ClinicalTrials.gov identifier : NCT01172652 .


Epinastine hydrochloride is a selective histamine H1 receptor antagonist that also inhibits IgE receptor-mediated histamine release from mast cells .


To show the superiority of epinastine 0.05 % ophthalmic solution ( epinastine ) to placebo ophthalmic solution ( placebo ) and noninferiority to olopatadine 0.1 % ophthalmic solution ( olopatadine ) for cedar pollen antigen-induced ocular itching and conjunctival hyperemia .


The study was conducted in ophthalmologically asymptomatic adult volunteers with seasonal allergic conjunctivitis using a conjunctival allergen challenge test .


Subjects were randomized into 3 groups ( n = 87 ) to evaluate superiority to placebo ( visits 4 to 6 ) and 2 groups ( n = 86 ) to evaluate noninferiority to olopatadine ( visit 7 ) .


At each visit , a single administration of the study medication was instilled at 15 minutes ( visit 4 ) , 4 hours ( visit 5 ) , 8 hours ( visit 6 ) , and 4 hours ( visit 7 ) before the conjunctival allergen challenge test .