In the high BNP group , rhBNP was more efficient than dobutamine at improving NYHA classification ( P < 0.05 ) , decreasing plasma BNP levels ( P < 0.05 ) , increasing LVEF ( P < 0.05 ) , and reducing hospital length of stay ( P < 0.05 ) .


However , rhBNP displayed no superior therapeutic efficacy to dobutamine in the extra-high BNP group .


Adverse cardiovascular events in patients treated with rhBNP were similar to adverse events in patients treated with dobutamine in both the high and extra-high BNP groups .


rhBNP was more efficient than dobutamine at improving heart function in patients with ADHF when plasma BNP was 3000 pg/mL .


However , rhBNP treatment showed no advantages over dobutamine when plasma BNP reached extremely high levels ( > 3000 pg/mL ) .


ClinicalTrials.gov Identifier : NCT01837849 .


This double-blind , placebo-controlled , dose-finding phase IIb study evaluated the efficacy and safety of ponesimod , an oral selective S1P1 receptor modulator , for the treatment of patients with relapsing-remitting multiple sclerosis ( RRMS ) .


464 patients were randomised to receive once-daily oral ponesimod 10 , 20 or 40 mg , or placebo for 24 weeks .


The primary endpoint was the cumulative number of new T1 gadolinium-enhanced ( T1 Gd + ) lesions per patient recorded every 4 weeks from weeks 12 to 24 after study drug initiation .


Secondary endpoints were the annualised confirmed relapse rate ( ARR ) and time to first confirmed relapse .


Safety and tolerability were also evaluated .


The mean cumulative number of new T1 Gd + lesions at weeks 12-24 was significantly lower in the ponesimod 10 mg ( 3.5 ; rate ratio ( RR ) 0.57 ; p = 0.0318 ) , 20 mg ( 1.1 ; RR 0.17 ; p < 0.0001 ) and 40 mg ( 1.4 ; RR 0.23 ; p < 0.0001 ) groups compared with placebo ( 6.2 ) .


The mean ARR was lower with 40mg ponesimod versus placebo , with a maximum reduction of 52 % ( 0.25 vs 0.53 ; p = 0.0363 ) .


The time to first confirmed relapse was increased with ponesimod compared with placebo .


The proportion of patients with 1 treatment-emergent adverse events ( AEs ) was similar across ponesimod groups and the placebo group .


Frequently reported AEs with higher incidence in the three ponesimod groups compared with placebo were anxiety , dizziness , dyspnoea , increased alanine aminotransferase , influenza , insomnia and peripheral oedema .


Once-daily treatment with ponesimod 10 , 20 or 40 mg significantly reduced the number of new T1 Gd + lesions and showed a beneficial effect on clinical endpoints .


Ponesimod was generally well tolerated , and further investigation of ponesimod for the treatment of RRMS is under consideration .


NCT01006265 .


Health professionals ' behaviour is a key component in compliance with evidence-based recommendations .


Opinion leaders are an oft-used method of influencing such behaviours in implementation studies , but reliably and cost effectively identifying them is not straightforward .


Survey and questionnaire based data collection methods have potential and carefully chosen items can - in theory - both aid identification of opinion leaders and help in the design of an implementation strategy itself .


This study compares two methods of identifying opinion leaders for behaviour-change interventions .


Healthcare professionals working in a single UK mental health NHS Foundation Trust were randomly allocated to one of two questionnaires .


The first , slightly longer questionnaire , asked for multiple nominations of opinion leaders , with specific information about the nature of the relationship with each nominee .


The second , shorter version , asked simply for a list of named `` champions '' but no more additional information .


We compared , using Chi Square statistics , both the questionnaire response rates and the number of health professionals likely to be influenced by the opinion leaders ( i.e. the `` coverage '' rates ) for both questionnaire conditions .


Both questionnaire versions had low response rates : only 15 % of health professionals named colleagues in the longer questionnaire and 13 % in the shorter version .


The opinion leaders identified by both methods had a low number of contacts ( range of coverage , 2-6 each ) .


There were no significant differences in response rates or coverage between the two identification methods .


The low response and population coverage rates for both questionnaire versions suggest that alternative methods of identifying opinion leaders for implementation studies may be more effective .


Future research should seek to identify and evaluate alternative , non-questionnaire based , methods of identifying opinion leaders in order to maximise their potential in organisational behaviour change interventions .


About 10 to 20 % of children in West European countries have atopic dermatitis ( AD ) , often as part of the atopic syndrome .


The full atopic syndrome also consists of allergic asthma , allergic rhinitis and food allergy .


Treatment approaches for atopic dermatitis and asthma include intermittent anti-inflammatory therapy with corticosteroids , health education and self-management training .


However , symptoms persist in a subgroup of patients .


Several observational studies have shown significant improvement in clinical symptoms in children and adults with atopic dermatitis or asthma after treatment at high altitude , but evidence on the efficacy when compared to treatment at sea level is still lacking .


This study is a pragmatic randomized controlled trial for children with moderate to severe AD within the atopic syndrome .


Patients are eligible for enrolment in the study if they are : diagnosed with moderate to severe AD within the atopic syndrome , aged between 8 and 18years , fluent in the Dutch language , have internet access at home , able to use the digital patient system Digital Eczema Center Utrecht ( DECU ) , willing and able to stay in Davos for a six week treatment period .


All data are collected at the Wilhelmina Children 's Hospital and DECU .


Patients are randomized over two groups .


The first group receives multidisciplinary inpatient treatment during six weeks at the Dutch Asthma Center in Davos , Switzerland .


The second group receives multidisciplinary treatment during six weeks at the outpatient clinic of the Wilhelmina Children 's Hospital , Utrecht , the Netherlands .


The trial is not conducted as a blind trial .


The trial is designed with three components : psychosocial , clinical and translational .


Primary outcomes are coping with itch , quality of life and disease activity .


Secondary outcomes include asthma control , medication use , parental quality of life , social and emotional wellbeing of the child and translational parameters .


The results of this trial will provide evidence for the efficacy of high altitude treatment compared to treatment at sea level for children with moderate to severe AD .


Current Controlled Trials ISRCTN88136485 .


Nasopharyngeal carcinoma ( NPC ) is one of the most common malignant tumors in southern China .


In this study , we compared the clinical efficacy and toxicity of cisplatin with nolatrexed ( LP ) or 5-fluorouracil ( FP ) for NPC .


33 patients with metastatic NPC were randomized to the LP and FP regimens .


The LP regimen consisted of continuous intravenous infusions of 740 mg/m ( 2 ) nolatrexed on days 1-5 and 25 mg/m ( 2 ) intravenous cisplatin on days 2-4 .


The FP regimen consisted of continuous intravenous infusions of 600 mg/m ( 2 ) 5-fluorouracil on days 1-5 and 25 mg/m ( 2 ) intravenous cisplatin on days 2-4 .


Cycles were repeated every 3 weeks until disease progression or completion of a total of 6 courses .


There were no significant differences in the response rates ( RR ) , disease control rates ( DCR ) , times to progression ( TTP ) , and median survival times ( MST ) between the regimens .


The toxicities of the two regimens were mostly grade I/II , but the stomatitis incidence in the patients on the LP regimen was significantly lower than that on the FP regimen .


The efficacy of the LP regimen was similar to that of the FP regimen .


The LP regimen had lower toxicity .


This study was designed to prospectively evaluate the role of nebulized hyaluronic acid ( HA ) given for 10 days/mo over 3 months as adjunct treatment to minimize symptoms and preventing exacerbation of chronic rhinosinusitis ( CRS ) .


Thirty-nine eligible patients were randomized to receive nebulized 9-mg sodium hyaluronate nasal washes plus saline solution ( 21 patients ) or 5 mL of saline alone ( 18 patients ) , according to an open-label , parallel-group design , with blind observer assessment .


A questionnaire about main CRS discomfort and nasal endoscopy for mucous discharge and/or mucosal edema of nasal cavities was used to assess primary outcomes of treatments .


Secondary outcome measures included side effects and satisfaction .


HA significantly improved quality of life in CRS patients according to the CRS questionnaire ( 16 3.72 versus 11.52 4.28 ; p < 0.001 ) , contrary to saline group scores ( 18.92 3.09 versus 18.21 3.21 ; p = 0.55 ) .


The HA group showed significantly reduced osteomeatal edema ( 2.42 versus 1.52 ; p < 0.001 ) and secretions ( 0.95 versus 0.42 ; p < 0.001 ) , whereas there was no statistically significant difference in the saline group .


The compliance to the treatment was similar in both groups and no side effects were recorded .


The results of this study suggested that intermittent treatment with topical 9-mg sodium hyaluronate plays a role in minimizing symptoms and could prevent exacerbations of CRS .


Irritable bowel syndrome ( IBS ) is a common diagnosis in gastroenterology .


Its etiology is unknown and therapeutic options limited .


Trials suggest probiotics may be beneficial .


The aim of this study was to assess the symptomatic efficacy of Lactobacillus plantarum 299 v ( L. plantarum 299 v ) for the relief of abdominal pain in patients with IBS fulfilling Rome II criteria .


This study was conducted in a referral hospital .


Trial participants were randomized to receive either two capsules of L. plantarum 299 v at a dosage of 5 10 ( 9 ) cfu per capsule or placebo daily for 8 wk .


Severity of abdominal pain was assessed using a visual analog scale at each visit and a quality-of-life IBS ( QoL-IBS ) questionnaire was also completed .


There was no significant difference in abdominal pain relief between the study and placebo groups ( P = 0.800 ) .


There was also no difference in QoL - IBS scores between the groups ( P = 0.687 ) .


Both groups had a significant improvement in abdominal pain scores over the study period , from an average of 251.55 to 197.90 ( P < 0.0001 ) indicating a large placebo effect .


An 8-wk treatment with L. plantarum 299 v did not provide symptomatic relief , particularly of abdominal pain and bloating , in patients fulfilling the Rome II criteria .


Elderly polypharmacy patients may be more at risk of not adhering to medication .


If so , the underlying reasons may be more readily disclosed during private discussions with patients .


Hence pharmaceutical care discussions at home might improve treatment adherence .


The aim of this study was to investigate the impact of pharmaceutical care on medication adherence , hospitalisation and mortality in elderly patients prescribed polypharmacy .


Pharmaceutical care discussed at home .


A randomised controlled trial with two arms ; pharmaceutical care ( n = 315 ) and controls ( n = 315 ) was designed .


It involved patients aged 65 + years living in Aarhus , Denmark who used five drugs or more without assistance .


Pharmacists visited the pharmaceuticalcare patients at home , once only , and followed them during the subsequent year with three telephone calls .


Non-adherence was measured by a pill-count .


Patients were categorised as non-adherent if their mean adherence rate for all drugs consumed was < 80 % .


The impact of pharmaceutical care on non-adherence and hospitalisation was analysed by 2 2 tables , and mortality by Cox regression .


Medication adherence , hospitalisation and mortality .


The final analyses included 517 patients ( median age 74 years ; females 52 % ) .


Dropouts were more frequent for the pharmaceutical-care group than for controls .


Pharmacists encountered drug-related problems amongst 72 % of pharmaceutical-care patients .


Pharmaceutical-care patients ( 11 % ) and control patients ( 10 % ) were similarly nonadherent ( Odds ratio 1.14 ; 95 % confidence interval 0.65-2 .00 ) , and similar with respect to hospitalisation frequency ( 30 vs. 28 % ; Odds ratio 1.14 ; 95 % confidence interval 0.78-1 .67 ) and mortality ( 7.5 vs. 5 % ; Hazard ratio 1.41 ; 95 % confidence interval 0.71-2 .82 ) .


Pharmaceutical care given to our elderly polypharmacy patients made no significant impact on medication adherence , hospitalisation or mortality , when compared to comparable control patients .


We aimed to determine the prevalence and risk factors for Strongyloides stercoralis infection in adult patients attending Siriraj Hospital , a tertiary hospital in Thailand .


A case-control study was carried out between July 2008 and April 2010 .


Case and control were identified from 6022 patients for whom results of faecal examination were available .


A case was a patient who had S. stercoralis larva detected from faecal examination .


Control was randomly selected from patients without S. stercoralis larvae detected in three consecutive faecal examinations .


The proportion of control to case was 2 : 1 .


Demographic and clinical data for the day of diagnosis and retrospectively up to 15 days preceding the date of faecal examination were reviewed from their medical records .


Overall , 149 ( 2.47 % ) patients had S. stercoralis larvae positive .


There were 105 males ( 70.5 % ) , with the mean ( SD ) age of 53.9 ( 17.2 ) years .


A total of 300 controls were selected .


Male gender ( odds ratio ( OR ) = 2.79 , 95 % confidence interval ( CI ) 1.78-4 .27 ) ) , human immunodeficiency virus ( HIV ) infection ( OR = 3.23 , 95 % CI 1.43-7 .29 ) , and eosinophilia ( OR = 1.81 , 95 % CI 1.33-2 .47 ) were found to be independent risk factors associated with S. stercoralis infection in this setting .


Corticosteroid or other immunosuppressive treatment , and other concomitant illnesses were not associated with increased risk of S. stercoralis infection .


In this setting , strongyloidiasis was seen more often in male patients with eosinophilia and with HIV infection .


Prevention of fatal complication caused by S. stercoralis by regular faecal examination , or serology for early detection and treatment of undiagnosed S. stercoralis infection , is warranted in these high-risk patients .


We hypothesized that valerian root might prevent cognitive dysfunction in coronary artery bypass graft ( CABG ) surgery patients through stimulating serotonin receptors and anti-inflammatory activity .


The aim of this study was to evaluate the effect of Valeriana officinalis root extract on prevention of early postoperative cognitive dysfunction after on-pump CABG surgery .


In a randomized , double-blind , placebo-controlled trial , 61 patients , aged between 30 and 70years , scheduled for elective CABG surgery using cardiopulmonary bypass ( CPB ) , were recruited into the study .


Patients were randomly divided into two groups who received either one valerian capsule containing 530mg of valerian root extract ( 1,060 mg/daily ) or placebo capsule each 12h for 8weeks , respectively .


For all patients , cognitive brain function was evaluated before the surgery and at 10-day and 2-month follow-up by Mini Mental State Examination ( MMSE ) test .


Mean MMSE score decreased from 27.032.02 in the preoperative period to 26.521.82 at the 10th day and then increased to 27.451.36 at the 60th day in the valerian group .


Conversely , its variation was reduced significantly after 60days in the placebo group , 27.371.87 at the baseline to 241.91 at the 10th day , and consequently slightly increased to 24.831.66 at the 60th day .


Valerian prophylaxis reduced odds of cognitive dysfunction compared to placebo group ( OR = 0.108 , 95 % CI 0.022-0 .545 ) .


We concluded that , based on this study , the cognitive state of patients in the valerian group was better than that in the placebo group after CABG ; therefore , it seems that the use of V. officinalis root extract may prevent early postoperative cognitive dysfunction after on-pump CABG surgery .


To assess lesion detection and diagnostic image quality of filtered back projection ( FBP ) reconstruction technique in ultra low-dose chest CT examinations .


In this IRB-approved ongoing prospective clinical study , 116 CT-image-series at four different radiation-doses were performed for 29 patients ( age , 57-87 years ; F : M - 15:12 ; BMI 16-32 kg/m ( 2 ) ) .


All patients provided written-informed-consent for the acquisitions of additional ultra low-dose ( ULD ) series on a 256-slice MDCT ( iCT , Philips Healthcare ) .


In-addition to their clinical standard-dose chest CT ( SD , 120 kV mean CTDIvol , 6 1 mGy ) , ULD-CT was subsequently performed at three-dose-levels ( 0.9 mGy [ 120 kV ] ; 0.5 mGy [ 100 kV ] and 0.2 mGy [ 80 kV ] ) .


Images were reconstructed with FBP ( 2.5 mm 1.25 mm ) resulting into four-stacks : SD-FBP ( reference-standard ) , FBP0 .9 , FBP0 .5 , and FBP0 .2 .


Four thoracic-radiologists from two-teaching-hospitals independently-evaluated data for lesion-detection and visibility-of-small-structures .


Friedman 's - non-parametric-test with post hoc Dunn 's - test was used for data-analysis .


Interobserver-agreement was substantial between radiologists ( k = 0.6-0 .8 ) .


With pooled analysis , 146-pulmonary ( 27-groundglass-opacities , 64-solid-lung-nodules , 7-consolidations , 27-emphysema ) and 347-mediastinal/soft tissue lesions ( 87-mediastinal , 46-hilar , 62-axillary-lymph-nodes , and 11-mediastinal-masses ) were evaluated .


Compared to the SD-FBP , 100 % pulmonary-lesions were seen with FBP0 .9 , up to 81 % with FBP0 .5 ( missed : 4 ) , and up to 30 % with FBP0 .2 images ( missed :16 ) .


Compared to SD-FBP , all enlarged mediastinal-lymph-nodes were seen with FBP0 .9 images .


All mediastinal-masses ( > 2 cm , 11/11 ) were seen equivalent to SD-FBP images at 0.9 mGy .


Across all sizes of patients , FBP0 .9 images had optimal visualization for lung findings .


They were optimal for mediastinal soft tissues for only non-obese patients .


Filtered-back-projection technique allows optimal lesion detection and acceptable image quality for chest-CT examinations at CDTIvol of 0.9 mGy for lung and mediastinal findings in selected sizes of patients .


We decided to determine the effectiveness of oral bromocriptine in patients with active rheumatoid arthritis ( RA ) who are in methotrexate ( MTX ) therapy .


Patients receiving stable doses of MTX were randomized to one of two groups and received 3 months of double-blind bromocriptine ( 5 mg/day ) or matching placebo .


The moderate and major outcome measures were the proportion of patients with > 0.6 and > 1.2 improvement in RA based on the Disease Activity Score 28 ( DAS28 ) at 3 months .


Safety measures included adverse events and laboratory assessments .


On a background treatment of MTX , the percentage of patients with moderate and major DAS28 responses at 3 months in the bromocriptine group ( 73.8 % / 59.5 % ) was not significantly different from placebo ( 63.1 % / 31.6 % ) .


Side effects were typically mild and included mild nausea and sleep disturbance ; we did not have any adverse events resulting in discontinuation of the study drug .


In patients with active RA receiving stable doses of MTX , bromocriptine showed non-significant improvement in efficiency outcomes compared to placebo .


Growth hormone ( GH ) treatment regimens do not account for the pubertal increase in endogenous GH secretion .


This study assessed whether increasing the GH dose and/or frequency of administration improves pubertal height gain and adult height ( AH ) in children with low GH secretion during stimulation tests , i.e. idiopathic isolated GH deficiency .


A multicenter , randomized , clinical trial ( No. 88-177 ) followed 111 children ( 96 boys ) at study start from onset of puberty to AH who had received GH 33 g/kg/day for 1 year .


They were randomized to receive 67 g/kg/day ( GH ( 67 ) ) given as one ( GH ( 671 ) ; n = 35 ) or two daily injections ( GH ( 332 ) ; n = 36 ) , or to remain on a single 33 g/kg/day dose ( GH ( 331 ) ; n = 40 ) .


Growth was assessed as heightSDSgain for prepubertal , pubertal and total periods , as well as AHSDS versus the population and the midparental height .


Pubertal heightSDSgain was greater for patients receiving a high dose ( GH ( 67 ) , 0.73 ) than a low dose ( GH ( 331 ) , 0.41 , p < 0.05 ) .


AHSDS was greater on GH ( 67 ) ( GH ( 671 ) , -0.84 ; GH ( 332 ) , -0.83 ) than GH ( 33 ) ( -1.25 , p < 0.05 ) , and heightSDSgain was greater on GH ( 67 ) than GH ( 33 ) ( 2.04 and 1.56 , respectively ; p < 0.01 ) .


All groups reached their target heightSDS .


Pubertal heightSDSgain and AHSDS were dose dependent , with greater growth being observed for the GH ( 67 ) than the GH ( 33 ) randomization group ; however , there were no differences between the once - and twice-daily GH ( 67 ) regimens .


2014 S. Karger AG , Basel .


Interventions that improve HbA1c levels do not necessarily improve health-related quality of life ( QoL ) .


This issue may be particularly relevant in asymptomatic diabetes patients detected earlier in the course of the disease .


HbA1c , diabetes-specific QoL ( ADDQoL ) and health status were measured in 510 screen-detected diabetes patients from the ADDITION-Cambridge trial at 1 and 5 years post diagnosis .


Multivariable logistic/linear regression was used to quantify the longitudinal association between change in HbA1c from 1 to 5 years and ADDQoL and health status at 5 years , adjusting for age , sex , education and trial group ; alcohol consumption , smoking , physical activity , plasma vitamin C , HbA1c , ADDQoL or health status at 1 year , and glucose-lowering medication at 5 years .


From 1 to 5 years , median HbA1c interquartile range increased from 6.3 % ( 5.9-6 .8 ) to 6.8 % ( 6.4-7 .4 ) ; the median ADDQoL score and mean health status physical health summary score decreased from -0.4 ( -1 to -0.08 ) to -0.5 ( -1.08 to -0.09 ) ( suggesting an adverse impact of diabetes on QoL ) and by -0.79 ( 8.94 ) points , respectively .


Increases in HbA1c were independently associated with reporting a negative impact of diabetes on QoL ( OR = 1.38 , 95 % CI : 1.03 to 1.85 ) but not with the health status summary scores .


Increases in HbA1c from 1 to 5 years post-diagnosis were independently associated with increased odds of reporting a negative impact of diabetes on QoL .


While our results suggest that efforts to reduce HbA1c do not adversely affect health-related QoL , large numbers of participants still report a negative impact of diabetes on their QoL 5 years post-diagnosis .


The purpose of the study was to determine the efficacy of a 10 % chlorhexidine tooth coating in reducing the incidence of cavitated carious lesions in adults .


The trial was a randomized , double-blind , multi-center , placebo controlled study with 983 participants , receiving the application of either the active or the placebo coatings to the entire dentition .


Four applications were made in the first month and one at the 7th month .


The final examination was performed at 13 months .


Coronal caries showed a statistical reduction ( p = 0.02 ) .


Examination of the results by site showed that the highest risk participants experienced the most significant preventive effect ( p = 0.003 ) .


When two sites ( uninsured and public health ) are pooled the treatment p-value is 0.0009 , interaction term has a p-value of 0.0001 .


10 % Chlorhexidine was highly effective in high risk participants with more than two cavities at the initial examination .


This trial in conjunction with other published trials of this topical medication indicates that chlorhexidine exerts its action by preventing the transition of D1 lesions to cavitated lesions , not on sound to D1 lesions .


The monoclonal anti-CD20 antibody rituximab , combined with chemotherapeutic agents , has been shown to prolong overall survival in physically fit patients with previously untreated chronic lymphocytic leukemia ( CLL ) but not in those with coexisting conditions .


We investigated the benefit of the type 2 , glycoengineered antibody obinutuzumab ( also known as GA101 ) as compared with that of rituximab , each combined with chlorambucil , in patients with previously untreated CLL and coexisting conditions .


We randomly assigned 781 patients with previously untreated CLL and a score higher than 6 on the Cumulative Illness Rating Scale ( CIRS ) ( range , 0 to 56 , with higher scores indicating worse health status ) or an estimated creatinine clearance of 30 to 69 ml per minute to receive chlorambucil , obinutuzumab plus chlorambucil , or rituximab plus chlorambucil .


The primary end point was investigator-assessed progression-free survival .


The patients had a median age of 73 years , creatinine clearance of 62 ml per minute , and CIRS score of 8 at baseline .


Treatment with obinutuzumab-chlorambucil or rituximab-chlorambucil , as compared with chlorambucil monotherapy , increased response rates and prolonged progression-free survival ( median progression-free survival , 26.7 months with obinutuzumab-chlorambucil vs. 11.1 months with chlorambucil alone ; hazard ratio for progression or death , 0.18 ; 95 % confidence interval [ CI ] , 0.13 to 0.24 ; P < 0.001 ; and 16.3 months with rituximab-chlorambucil vs. 11.1 months with chlorambucil alone ; hazard ratio , 0.44 ; 95 % CI , 0.34 to 0.57 ; P < 0.001 ) .


Treatment with obinutuzumab-chlorambucil , as compared with chlorambucil alone , prolonged overall survival ( hazard ratio for death , 0.41 ; 95 % CI , 0.23 to 0.74 ; P = 0.002 ) .


Treatment with obinutuzumab-chlorambucil , as compared with rituximab-chlorambucil , resulted in prolongation of progression-free survival ( hazard ratio , 0.39 ; 95 % CI , 0.31 to 0.49 ; P < 0.001 ) and higher rates of complete response ( 20.7 % vs. 7.0 % ) and molecular response .


Infusion-related reactions and neutropenia were more common with obinutuzumab-chlorambucil than with rituximab-chlorambucil , but the risk of infection was not increased .


Combining an anti-CD20 antibody with chemotherapy improved outcomes in patients with CLL and coexisting conditions .


In this patient population , obinutuzumab was superior to rituximab when each was combined with chlorambucil .


( Funded by F. Hoffmann-La Roche ; ClinicalTrials.gov number , NCT01010061 . )


Enterovirus 71 ( EV71 ) is one of the major causative agents of outbreaks of hand , foot , and mouth disease or herpangina worldwide .


This phase 3 trial was designed to evaluate the efficacy , safety , and immunogenicity of an EV71 vaccine .


We conducted a randomized , double-blind , placebo-controlled , multicenter trial in which 10,007 healthy infants and young children ( 6 to 35 months of age ) were randomly assigned in a 1:1 ratio to receive two intramuscular doses of either EV71 vaccine or placebo , 28 days apart .


The surveillance period was 12 months .


The primary end point was the occurrence of EV71-associated hand , foot , and mouth disease or herpangina .


During the 12-month surveillance period , EV71-associated disease was identified in 0.3 % of vaccine recipients ( 13 of 5041 children ) and 2.1 % of placebo recipients ( 106 of 5028 children ) in the intention-to-treat cohort .


The vaccine efficacy against EV71-associated hand , foot , and mouth disease or herpangina was 94.8 % ( 95 % confidence interval [ CI ] , 87.2 to 97.9 ; P < 0.001 ) in this cohort .


Vaccine efficacies against EV71-associated hospitalization ( 0 cases vs. 24 cases ) and hand , foot , and mouth disease with neurologic complications ( 0 cases vs. 8 cases ) were both 100 % ( 95 % CI , 83.7 to 100 and 42.6 to 100 , respectively ) .


Serious adverse events occurred in 111 of 5044 children in the vaccine group ( 2.2 % ) and 131 of 5033 children in the placebo group ( 2.6 % ) .


In the immunogenicity subgroup ( 1291 children ) , an anti-EV71 immune response was elicited by the two-dose vaccine series in 98.8 % of participants at day 56 .


An anti-EV71 neutralizing antibody titer of 1:16 was associated with protection against EV71-associated hand , foot , and mouth disease or herpangina .


The EV71 vaccine provided protection against EV71-associated hand , foot , and mouth disease or herpangina in infants and young children .


( Funded by Sinovac Biotech ; ClinicalTrials.gov number , NCT01507857 . )


Ischemic or volatile anesthetic preconditioning is defined as tissue protection from impending ischemic cell damage by repetitive short periods of tissue exposure to ischemia or volatile anesthetics .


Objective of this study was to elucidate , if ischemic preconditioning and pharmacological preconditioning with sevoflurane have effects on muscle tissue oxygen saturation in patients undergoing surgical revascularization of the lower limb .


In this prospective randomized pilot study ischemic and pharmacological ( sevoflurane ) preconditioning was performed in 40 patients with lower limb arterial occlusive disease undergoing surgical revascularization .


Sevoflurane preconditioning was performed in one group ( N = 20 ) by repetitive application of sevoflurane for six minutes interspersed by six minutes of washout .


Thereafter , ischemic preconditioning was performed in all patients ( N = 40 ) by repetitive clamping of the femoral artery for six minutes interspersed by six minutes of reperfusion .


The effect of both procedures on leg muscle tissue oxygen saturation ( rSO2 ) was measured by near-infrared spectroscopy during both procedures and during surgery and reperfusion ( INVOS 5100C Oxymeter with Small Adult SomaSensor SAFB-SM , Somanetics , Troy , Michigan , USA ) .


Repetitive clamping and reperfusion of the femoral artery resulted in significant cyclic decrease and increase of muscle rSO2 ( p < 0.0001 ) .


Pharmacological preconditioning with sevoflurane resulted in a faster and higher increase of rSO2 during postoperative reperfusion ( Maximal 111 % baseline20 versus 103 % baseline14 , p = 0.008 ) consistent with an additional effect of pharmacological preconditioning on leg perfusion .


Ischemic preconditioning of lower limb muscle tissue and pharmacological preconditioning with sevoflurane have an effect on tissue oxygenation in patients with lower limb occlusive arterial disease .


The trial has been registrated at http://www.ClinicalTrial.gov ,


NCT02038062 at 14 January 2014 .


To compare stent strut coverage using optical coherence tomography ( OCT ) at three-month follow-up between a PLGA-polymer with electro-grafting base layer sirolimus-eluting stent ( SES ) ( BuMA ) and a PLA-polymer SES ( EXCEL ) .


This prospective , single-centre , non-inferiority randomised BuMA-OCT trial enrolled patients with de novo coronary artery lesions , treated with either the BuMA or the EXCEL stent .


The study primary endpoint was OCT-evaluated stent strut coverage at three months .


Secondary endpoints were neointimal thickness of stent struts , and incomplete stent apposition evaluated with OCT. .


A total of 80 patients were randomly assigned to receive the BuMA ( n = 40 ) or the EXCEL ( n = 40 ) stent .


In OCT follow-up ( achieved in 86.3 % of cases : BuMA , n = 33 ; EXCEL , n = 36 ) , the percentage of stent strut coverage was significantly higher in the BuMA vs. the EXCEL group ( strut level : 94.2 % vs. 90.0 % , p < 0.01 ; p ( non-inferiority ) < 0.0001 ; p ( superiority ) < 0.0001 ) , while the proportion of malapposed struts ( strut level : 1.28 % vs. 1.80 % , p = 0.51 ) and the mean neointimal thickness ( strut level : 0.070.03 mm vs. 0.060.02 mm , p = 0.31 ) were similar .


Rates of myocardial infarction ( periprocedural non-Q-wave , 7.5 % vs. 7.5 % , p = 1.00 ) and target lesion failure ( 7.5 % vs. 7.5 % , p = 1.00 ) were similar between groups , with no cardiac death or stent thrombosis .


In the BuMA-OCT randomised trial , the novel BuMA PLGA-polymer with electro-grafting base layer SES was superior to the EXCEL PLA-polymer SES in the primary endpoint of stent strut coverage at three-month follow-up .


To determine the effect of thermal state and thermal comfort on cycling performance in the heat .


Seven well-trained male triathletes completed 3 performance trials consisting of 60 min cycling at a fixed rating of perceived exertion ( 14 ) followed immediately by a 20-km time trial in hot ( 30C ) and humid ( 80 % relative humidity ) conditions .


In a randomized order , cyclists either drank ambient-temperature ( 30C ) fluid ad libitum during exercise ( CON ) , drank ice slurry ( -1 C ) ad libitum during exercise ( ICE ) , or precooled with iced towels and ice slurry ingestion ( 15 g/kg ) before drinking ice slurry ad libitum during exercise ( PC+ICE ) .


Power output , rectal temperature , and ratings of thermal comfort were measured .


Overall mean power output was possibly higher in ICE ( +1.4 % 1.8 % [ 90 % confidence limit ] ; 0.4 > smallest worthwhile change [ SWC ] ) and likely higher PC+ICE ( +2.5 % 1.9 % ; 1.5 > SWC ) than in CON ; however , no substantial differences were shown between PC+ICE and ICE ( unclear ) .


Time-trial performance was likely enhanced in ICE compared with CON ( +2.4 % 2.7 % ; 1.4 > SWC ) and PC+ICE ( +2.9 % 3.2 % ; 1.9 > SWC ) .


Differences in mean rectal temperature during exercise were unclear between trials .


Ratings of thermal comfort were likely and very likely lower during exercise in ICE and PC+ICE , respectively , than in CON .


While PC+ICE had a stronger effect on mean power output compared with CON than ICE did , the ICE strategy enhanced late-stage time-trial performance the most .


Findings suggest that thermal comfort may be as important as thermal state for maximizing performance in the heat .


Prior studies have reported 2-L polyethylene glycol ( PEG ) plus ascorbic acid ( PEG + Asc ) is an effective alternative to standard 4-L PEG for bowel preparation before colonoscopy , but they are limited because of some confounders .


Therefore , we compared the efficacy , patient compliance , satisfaction , and safety of 2-L PEG + Asc versus 4-L PEG for bowel cleansing in optimal preparation strategies .


In this prospective , randomized , single-blind trial , consenting outpatients were randomly assigned to one of two arms .


All colonoscopies were scheduled in the morning and cleansing solutions were administered as a split-dose regimen .


Bowel-cleansing efficacy in three different segments was measured on a five-point scale with four-point overall grading .


Patients ' opinions of the preparation regimens were obtained by questionnaire .


There was no significant difference between the 2-L PEG + Asc ( 159/163 ; 97.5 % ) and 4-L PEG ( 162/164 ; 98.8 % ) with respect to the overall success of bowel cleansing ( mean difference = -1.3 [ -4.1 - ] ) .


Patient compliance , acceptability , and satisfaction were better in the 2-L PEG + Asc arm than the 4-L PEG arm ( P < 0.05 ) .


Additionally , the incidence of side effects was lower in the 2-L PEG + Asc than the 4-L PEG ( overall , 57.7 % vs 73.2 % , P < 0.05 ) .


However , no significant difference was seen in patients ' rating of taste .


In an optimal preparation setting , 2-L PEG + Asc has equal efficacy as a bowel cleanser prior to colonoscopy as 4-L PEG , with the advantages of better patient compliance , satisfaction , and safety .


The use of bupropion , a smoking cessation aid , has been associated with improved health-related quality of life ( HRQOL ) in the general population of smokers ; but , its effect on HRQOL in post-myocardial infarction ( MI ) patients remains unknown .


To examine the effect of bupropion on HRQOL in post-MI patients who are attempting to quit smoking .


To accomplish this objective , we used data from a randomized , double-blind , placebo-controlled trial in 392 hospitalized post-MI patients .


Treatment duration was 9 weeks , and follow-up was 12 months .


HRQOL was assessed via the EuroQol-5D ( EQ-5D ) questionnaire , which includes 5 dimensions ( mobility , self-care , daily activities , pain/discomfort , and anxiety/depression ) .


Analyses were restricted to patients ( n = 225 ) who completed the EQ-5D at baseline , 6 months , and 12 months .


Patients randomized to bupropion ( n = 109 ) and those randomized to placebo ( n = 116 ) experienced similar improvements in HRQOL during follow-up ( difference in change in EQ-5D index from baseline to 6 months = 0.02 , 95 % confidence interval [ CI ] = -0.04 , 0.08 ; from baseline to 12 months = 0.02 , 95 % CI = -0.04 , 0.08 ) .


No between-group differences were observed in any of the 5 dimensions .


Similar improvements in HRQOL were observed between patients who remained abstinent and those who relapsed .


Lower baseline HRQOL , defined as having a HRQOL that was less than the median value , was associated with decreased smoking abstinence at 12 months follow-up ( odds ratio OR = 0.39 , 95 % CI = 0.22 , 0.68 ) .


Bupropion does not improve HRQOL among patients attempting to quit smoking post-MI .


To evaluate angiographic and clinical outcomes associated with open and closed dissection tunnel endoscopic vein harvesting ( EVH ) devices .


A previous PREVENT-IV ( PRoject of Ex-vivo Vein graft ENgineering via Transfection IV ) analysis reported that EVH for coronary artery bypass graft surgery was associated with worse outcomes than with traditional vein harvesting ; however , outcomes by EVH device type were not available .


Using data from the PREVENT-IV trial , we compared 1549 patients from 75 surgical sites who underwent EVH with open ( n = 390 ) or closed ( n = 1159 ) harvest tunnel devices .


Outcomes included the incidence of vein graft failure at 12 to 18 months and a composite of death , myocardial infarction , and revascularization through 5 years .


Among patients undergoing open and closed tunnel EVH , no difference in the per-patient incidence of vein graft failure ( 43.8 % vs 47.1 % ; adjusted odds ratio , 0.91 ; 95 % confidence interval , 0.53-1 .55 ; P = 0.724 ) or per-graft incidence of vein graft failure ( 25.5 % vs 25.9 % ; adjusted odds ratio , 0.96 ; 95 % confidence interval , 0.59-1 .55 ; P = 0.847 ) was observed .


At 5 years , no difference was observed in the primary composite clinical outcome between patients who underwent open and closed system EVH ( 21.5 % vs 23.9 % ; adjusted hazard ratio , 0.85 ; 95 % confidence interval , 0.66-1 .10 ; P = 0.221 ) .


No differences in angiographic or clinical outcomes were observed among patients who underwent open versus closed tunnel endoscopic harvesting for coronary bypass surgery .


These findings suggest that the risks associated with EVH that were reported in a previous PREVENT-IV analysis are not related to a specific EVH device .


Although dry socket ( DS ) is commonly investigated , many of its risk factors remain highly controversial .


In addition , few studies are available to show the preventive effect of chlorhexidine gel on DS .


Moreover , multivariable analyses of DS risk factors are scarce , and their interactions have not been assessed previously .


Therefore , the simultaneous effect of chlorhexidine gel and 4 DS risk factors and their interactions were analyzed within a multivariable framework .


Using a split-mouth randomized clinical trial design , the investigators enrolled a cohort of patients requiring extraction of 2 mandibular third molars .


The primary predictor variable was extraction socket treatment status , classified as experimental or standard .


Experimental treatment was the insertion of chlorhexidine gel ( 0.2 % ) into the extraction socket .


Each patient had 1 third molar randomly selected as the treatment site .


The contralateral third molar served as the control socket and was treated in the usual manner .


The primary outcome variable was DS status , present or absent , assessed on postoperative day 3 .


Other study variables were categorized as demographic , smoking , and surgical difficulty according to the Pederson scale .


Appropriate bivariate and multiple logistic regression statistics were used to measure the association between risk for DS and chlorhexidine gel use , age , gender , smoking , and surgical difficulty and their interactions ( = 0.05 ) .


The sample consisted of 90 bilateral extraction sockets in 45 patients ( 24 men ; 21 smokers ; mean age , 21.1 2.7 yr ) .


Regression analysis showed that when other factors and their interactions were controlled for , chlorhexidine gel application lowered the risk of DS ( odds ratio [ OR ] = 0.05 ; P = .004 ) .


Increasing age ( OR = 2.9 ; P = .030 ) was associated with an increased risk for DS .


A similar association existed between increased difficulty level of extraction and DS risk ( OR = 3.8 ; P = .051 ) .


The effect of gender was marginally significant ( P = .091 ) , whereas smoking did not have a significant influence ( P = .4 ) .


Intra-alveolar application of chlorhexidine gel and practicing less traumatic surgeries are advocated , particularly in older patients .


Smoking seems unlikely to affect DS frequency .


The role of gender is inconclusive .


To observe the lower gastrointestinal mesenchymal tumors CT virtual endoscopy and pathology , and to explore its possible mechanism .


Select 80 patients suspected colon gastroenterology treat in the hospital gastroenterology department , randomly divided into experimental group and control group , 40 cases in experimental group were given CT virtual endoscopy and pathological check , the control group received conventional colonoscopy and pathological check , and all the results compared with the pathological results .


Compared with the pathological test results , consistent rate with the experimental group reached 94.73 % , the same rate was 92.85 % in control group .


The difference was not statistically significant ( P > 0.05 ) .


CT virtual endoscopy can quickly image and draw detailed information , and can improve the sensitivity and specificity of cancer diagnosis greatly .


Clinically , CT virtual endoscopy have the same function as colonoscopy , can replace colonoscopy , can be important complement of electronic colonoscopy by those who can not tolerate electronic colonoscopy or have contraindications .


Its value is worth taking a step forward in-depth study .


Weight losses in lifestyle interventions are variable , yet prediction of long-term success is difficult .


The utility of using various weight loss thresholds in the first 2 months of treatment for predicting 1-year outcomes was examined .


Participants included 2327 adults with type 2 diabetes ( BMI :35.86.0 ) randomized to the intensive lifestyle intervention ( ILI ) of the Look AHEAD trial .


ILI included weekly behavioral sessions designed to increase physical activity and reduce caloric intake .


1-month , 2-month , and 1-year weight changes were calculated .


Participants failing to achieve a 2 % weight loss at Month 1 were 5.6 ( 95 % CI :4.5 , 7.0 ) times more likely to also not achieve a 10 % weight loss at Year 1 , compared to those losing 2 % initially .


These odds were increased to 11.6 ( 95 % CI :8.6 , 15.6 ) when using a 3 % weight loss threshold at Month 2 .


Only 15.2 % and 8.2 % of individuals failing to achieve the 2 % and 3 % thresholds at Months 1 and 2 , respectively , go on to achieve a 10 % weight loss at Year 1 .


Given the association between initial and 1-year weight loss , the first few months of treatment may be an opportune time to identify those who are unsuccessful and utilize rescue efforts .


clinicaltrials.gov Identifier : NCT00017953 .


The rapid rise in the number of methamphetamine users , relative to cocaine users , has brought the number of each to nearly equal levels , making research on similarities and differences across these groups a needed area of exploration .


Craving is postulated to play a significant role in relapse for both user types , yet group differences on observed scale scores have been reported without first assessing the prerequisite measurement equivalence ( invariance ) of the items , which is essential for meaningful group comparisons .


Baseline data from stimulant users in residential treatment ( N = 301 ; n = 177 cocaine ; n = 124 methamphetamine ) were used to assess the measurement invariance of the 10-item Stimulant Craving Questionnaire ( STCQ ) , which was adapted from a cocaine-specific measure .


The unifactorial STCQ demonstrated measurement invariance across cocaine and methamphetamine users for factor loadings ( metric ) , common residual covariances between item pairs , and item intercepts ( scalar ) , as determined by fit indices ( RMSEA < 0.05 ; CFI & TLI > 0.95 ; SRMR < 0.10 ) .


The latent mean , as well as 5 ( out of 10 ) item means and the overall composite scale score , was significantly greater for methamphetamine users compared to cocaine users .


Results indicate the STCQ is an invariant tool for the assessment of stimulant craving across the two most prevalent user types .


Methamphetamine users had significantly higher levels of observed and latent craving than cocaine users , demonstrating a potentially meaningful difference in craving between users of these two stimulants .


Future research will determine if treatments and statistical models need to account for craving variations across methamphetamine and cocaine users .


The COPD Assessment Test ( CAT ) has been proposed for assessing health status in COPD , but little is known about its longitudinal changes .


The objective of this study was to evaluate 1-year CAT variability in patients with stable COPD and to relate its variations to changes in other disease markers .


We evaluated the following variables in smokers with and without COPD at baseline and after 1 year : CAT score , age , sex , smoking status , pack-year history , BMI , modified Medical Research Council ( mMRC ) scale , 6-min walk distance ( 6MWD ) , lung function , BODE ( BMI , obstruction , dyspnea , exercise capacity ) index , hospital admissions , Hospital and Depression Scale , and the Charlson comorbidity index .


In patients with COPD , we explored the association of CAT scores and 1-year changes in the studied parameters .


A total of 824 smokers with COPD and 126 without COPD were evaluated at baseline and 441 smokers with COPD and 66 without COPD 1 year later .


At 1 year , CAT scores for patients with COPD were similar ( 4 points ) in 56 % , higher in 27 % , and lower in 17 % .


Of note , mMRC scale scores were similar ( 1 point ) in 46 % of patients , worse in 36 % , and better in 18 % at 1 year .


One-year CAT changes were best predicted by changes in mMRC scale scores ( - coefficient , 0.47 ; P < .001 ) .


Similar results were found for CAT and mMRC scale score in smokers without COPD .


One-year longitudinal data show variability in CAT scores among patients with stable COPD similar to mMRC scale score , which is the best predictor of 1-year CAT changes .


Further longitudinal studies should confirm long-term CAT variability and its clinical applicability .


ClinicalTrials.gov ; No. : NCT01122758 ; URL : www.clinicaltrials.gov .


Urethral stricture is one of the oldest diseases Urethral dilatation Internal optical urethrotomy , were the only treatment .


Clean Intermittent Self Catheterisation was introduced by Lapides has greatly decreased the recurrence of stricture .


Objectives were to determine the role of Clean Intermittent Self Catheterisation ( CISC ) in the prevention of recurrence of urethral strictures after Internal Optical Urethrotomy and to study the frequency of any postoperative complications and tolerability for the patients associated with this procedure .


A randomised controlled study conducted in the department of urology and renal transplantation , Institute of Kidney Diseases Hayatabad Medical Complex , Peshawar from June 2007 to June 2010 .


Total of 60 patients with mean age 48 years ( range 20-73 ) were selected and randomly divided into Treatment Group ( 30 patients ) and Control Group ( 30 Patients ) .


Eight `` drop out '' occurred in the treatment group and four `` drop out '' occurred in the controlled group .


All the patients were treated with Internal Optical Urethrotomy using Sachse method followed by indwelling catheter for 5 days .


The treatment group was then taught to perform Clean Intermittent Self Catheterisation by inserting a Classic Neleton Catheter ( No. 16 or 18 ) twice a day for 1 week , then once a day for another 4 weeks and then once weekly continued for one year .


All the patients were followed up regularly at 1 month intervals during the first 6 months and then every 2 months for the next 6 months .


Total of 48 patients completed the study , 22 in the treatment group and 26 in the control group .


Within the first year , 4 patients ( 22 % ) in the treatment group developed urethral stricture .


In the control group , 12 patients ( 46 % ) developed urethral stricture within the first year , showing a significant difference ( p < 0.01 ) .


In the treatment group four patients developed simple UTIs while in the control group three patients developed UTIs , one with concomitant epididymitis .


No other complications were noted up to one year follow up .


Clean Intermittent Self Catheterisation is a simple and effective way of reducing stricture recurrence after Internal Optical Urethrotomy and is associated with less morbidity and is cost effective .


CISC is an important modality for maintaining the normal urethral calibre .


Otitis media ( OM ) starts within weeks of birth in almost all Indigenous infants living in remote areas of the Northern Territory ( NT ) .


OM and associated hearing loss persist from infancy throughout childhood and often into adulthood .


Educational and social opportunities are greatly compromised .


Pneumococcus and non-typeable Haemophilus influenzae ( NTHi ) are major OM pathogens that densely colonise the nasopharynx and infect the middle ear from very early in life .


Our hypothesis is that compared to current single vaccine schedules , a combination of vaccines starting at 1month of age , may provide earlier , broadened protection .


This randomised outcome assessor , blinded controlled trial will recruit 425 infants between 28 and 38days of age and randomly allocate them ( 1:1:1 ) to one of three pneumococcal conjugate vaccine ( PCV ) schedules : Synflorix at 2 , 4 , 6months of age , Prevenar13 at 2 , 4 and 6months of age , or an investigational schedule of Synflorix at 1 , 2 and 4months plus Prevenar13 at 6months of age .


The blinded primary outcomes at 7months of age are immunogenicity of specific vaccine antigens ( geometric mean concentration ( GMC ) and proportion of participants with above threshold GMC of 0.35 g/L ) .


Secondary outcomes at all timepoints are additional immunogenicity measures and proportion of participants with nasopharyngeal carriage of vaccine-type pneumococci and NTHi , and any OM , including any tympanic membrane perforation .


Parental interviews will provide data on common risk factors for OM .


Ethical approval has been obtained from NT Department of Health and Menzies HREC ( EC00153 ) , Central Australian HREC ( EC00155 ) and West Australian Aboriginal Health Ethics Committee ( WAAHEC - 377-12/2011 ) .


Final trial results , data analyses , interpretation and conclusions will be presented in appropriate written and oral formats to parents and guardians , participating communities , local , national and international conferences , and published in peer-reviewed open access journals .


ACTRN12610000544077 and NCT01174849 .


Severe knee contractures that develop soon after muscle imbalance may not improve with stretching exercises and splinting .


An alternative treatment is serial casting , which has been used to promote increased range of motion .


The purpose of this study was to compare the effectiveness of using serial casting and passive stretching approaches to treat knee flexion contracture in children with spina bifida .


In a pre/post randomized controlled study , ten participants were included in the serial casting group , while eight participants were included in the passive stretching intervention group .


The degree of knee extension was measured at baseline , immediately after intervention , and at a one-year follow-up using a standard goniometer .


Both groups showed significant improvements in the degree of flexion contracture at the post-treatment evaluation and the follow-up evaluation .


The serial casting group showed significant improvements in knee flexion contracture at the post-treatment evaluation , t ( 9 ) = 13.4 , p < 0.001 , and the one-year follow-up evaluation , t ( 9 ) = 7.46 , p < 0.001 .


The passive stretching group also showed significant improvements in knee flexion contracture at the post-treatment evaluation , t ( 7 ) = 2.6 , p < 0.05 , and the one-year follow-up evaluation , t ( 7 ) = 3.6 , p < 0.05 .


However , statistically significant improvements in the serial casting group compared with passive stretching group in relation to the degree of flexion contracture were found at the immediate post-treatment evaluation , F ( 1 , 15 ) = 246 , p = 0.0001 , and the one-year follow-up evaluation , F ( 1 , 15 ) = 51.5 , p = 0.0001 .


The outcomes of this study provide the first evidence that serial casting may be a useful intervention in treating knee flexion contracture in children with spina bifida .


However , further investigations into serial casting , as well as investigations into the use of serial casting with other interventions , are warranted .


The authors tested whether clonidine blocks stress-induced seeking of heroin and cocaine .


The study was also intended to confirm translational findings from a rat model of drug relapse by using ecological momentary assessment of patients ' stress to test hypotheses about clonidine 's behavioral mechanism of action .


The authors conducted a randomized double-blind placebo-controlled clinical trial with 208 opioid-dependent patients at an outpatient buprenorphine clinic .


The 118 participants ( 57 % ) who maintained abstinence during weeks 5-6 were continued on buprenorphine and randomly assigned to receive clonidine ( N = 61 ) or placebo ( N = 57 ) for 14 weeks .


Urine was tested thrice weekly .


Lapse was defined as any opioid-positive or missed urine test , and relapse as two or more consecutive lapses .


Time to lapse and relapse were examined with Cox regressions ; longest period of abstinence was examined with a t test , and ecological momentary assessment data were examined with generalized linear mixed models .


In an intent-to-treat analysis , clonidine produced the longest duration ( in consecutive days ) of abstinence from opioids during the intervention phase ( 34.8 days [ SD = 3.7 ] compared with 25.5 days [ SD = 2.7 ] ; Cohen 's d = 0.38 ) .


There was no group difference in time to relapse , but the clonidine group took longer to lapse ( hazard ratio = 0.67 , 95 % CI = 0.45-1 .00 ) .


Ecological momentary assessment showed that daily-life stress was partly decoupled from opioid craving in the clonidine group , supporting the authors ' hypothesized mechanism for clonidine 's benefits .


Clonidine , a readily available medication , is useful in opioid dependence not just for reduction of withdrawal signs , but also as an adjunctive maintenance treatment that increases duration of abstinence .


Even in the absence of physical withdrawal , it decouples stress from craving in everyday life .


Evaluate long-term effects of group interventions on sleep and pain outcomes in a primary care population of older adults with osteoarthritis pain and sleep disturbance .


Double-blind , cluster-randomized controlled trial with 18-mo follow-up .


Group Health and University of Washington , Seattle , WA , from 2009 to 2011 .


Three hundred sixty-seven adults age 60 y and older , with osteoarthritis pain and insomnia symptoms .


Six weekly sessions of group cognitive behavioral therapy for insomnia and pain ( CBT-PI ) , pain alone ( CBT-P ) , and education-only control ( EOC ) delivered in patients ' primary care clinics .


There were no significant differences between treatment groups in sleep outcomes at 18 mo. .


This is a change from published significant 9-mo follow-up results for insomnia severity ( Insomnia Severity Index ) and sleep efficiency .


There were no significant treatment differences in pain at either follow-up .


Post hoc analyses of participants with greater insomnia and pain severity at baseline ( n = 98 ) showed significant ( P = 0.01 ) 18-mo reductions in pain comparing CBT-PI versus CBT-P ( adjusted mean difference [ AMD ] = -1.29 [ 95 % confidence interval ( CI ) : -2.24 , -0.33 ] ) .


Moderate , albeit nonsignificant , CBT-PI versus EOC treatment effects for insomnia severity ( AMD = -1.43 [ 95 % CI : -4.71 , 1.86 ] ) and sleep efficiency ( AMD = 2.50 [ 95 % CI : -5.04 , 10.05 ] ) were also observed .


Possible trial design and methodological considerations that may have affected results are discussed .


Results suggest patients with higher levels of comorbid pain and insomnia may be most likely to experience sustained benefit from cognitive behavioral therapy interventions over time , and inclusion of insomnia treatment may yield more clinically meaningful improvements than cognitive behavioral therapy for pain alone .


clinicaltrials.gov identifier : NCT01142349 .


To compare the efficacy of two standard surgical procedures for post-hysterectomy vaginal vault prolapse in patients with levator ani avulsion .


This was a single-center , randomized interventional trial , of two standard surgical procedures for post-hysterectomy vaginal vault prolapse : Prolift Total vs unilateral vaginal sacrospinous colpopexy with native tissue vaginal repair ( sacrospinous fixation , SSF ) , during the period from 2008 to 2011 .


Entry criteria included at least two-compartment prolapse , as well as complete unilateral or bilateral levator ani avulsion injury .


The primary outcome was anatomical failure based on clinical and ultrasound assessment .


Failure was defined clinically , according to the Pelvic Organ Prolapse Quantification system , as Ba , C or Bp at the hymen or below , and on translabial ultrasound as bladder descent to 10 mm or more below the lower margin of the symphysis pubis on maximum Valsalva maneuver .


Secondary outcomes were evaluation of continence , sexual function and prolapse symptoms based on validated questionnaires .


During the study period , 142 patients who were post-hysterectomy underwent surgery for prolapse in our unit ; 72 of these were diagnosed with an avulsion injury and were offered participation in the study .


Seventy patients were randomized into two groups : 36 in the Prolift group and 34 in the SSF group .


On clinical examination at 1-year follow-up , we observed one ( 3 % ) case of anatomical failure in the Prolift group and 22 ( 65 % ) in the SSF group ( P < 0.001 ) .


Using ultrasound criteria , there was one ( 2.8 % ) failure in the Prolift group compared with 21 ( 61.8 % ) in the SSF group ( P < 0.001 ) .


The postoperative POPDI ( Pelvic Organ Prolapse Distress Inventory ) score for subjective outcome was 15.3 in the Prolift group vs 21.7 in the SSF group ( P = 0.16 ) .


In patients with prolapse after hysterectomy and levator ani avulsion injury , SSF has a higher anatomical failure rate than does the Prolift Total procedure at 1-year follow-up .


The aim of this randomised controlled trial was to assess the clinical performance of single crowns in the posterior maxilla supported by either 6-mm or 11-mm implants combined with maxillary sinus floor elevation .


41 consecutive patients with one missing premolar or molar in the posterior maxilla and with an estimated bone height of 6 to 8 mm in that area were included .


Each patient was randomly allocated to one of the two treatment groups , namely to receive an 11-mm implant ( Osseo Speed 4.0 S , Dentsply Implants , Mlndal , Sweden ) in combination with maxillary sinus floor elevation surgery or to receive a 6-mm implant ( Osseo Speed 4.0 S ) without any grafting .


After a 3-month osseointegration period , all implants were restored with custom-made titanium abutments and cemented zirconia-based porcelain crowns .


Outcome measures were : implant survival ; radiographic bone changes ; plaque accumulation ; bleeding tendency ; peri-implant inflammation ; presence of dental calculus ; biological and technical complications ; and patients ' satisfaction .


Clinical and radiographic examinations were performed at placement of the crown and 12 months thereafter .


Patients ' satisfaction was scored before treatment and after 12 months of functioning of the crown .


One patient of the 11 mm implant group died during the follow-up .


No implant failed and no biological or technical complications occurred .


From loading to the 12 months follow-up , no difference was found in mean marginal bone changes between the groups ( bone resorption in both groups 0.1 0.3 mm ) .


Clinical items revealed very healthy peri-implant soft tissues in both groups .


Patients ' satisfaction scores were high in both groups .


6-mm implants and 11-mm implants combined with sinus floor elevation surgery are equally successful to support a single crown in the resorbed posterior maxilla after 1-year follow-up .


In accordance with the European Association of Urology guidelines , a second transurethral resection of the bladder ( TURB ) is recommended for high-grade or T1-category tumors .


This practice brings into question the benefit of photodynamic diagnosis ( PDD ) in reducing the residual disease after TURB in patients with positive results on urine cytology showing high-grade cancer cells .


A prospective , bicentric , randomized study comparing white light cystoscopy ( WLC ) + PDD with hexaminolevulinate arm with WLC alone ( control arm ) during the first TURB in patients with primary non-muscle-invasive bladder cancer and with positive results on urine cytology showing high-grade cancer cells .


Patients underwent a first TURB with WLC and PDD or WLC alone , and then a second TURB with WLC and PDD , after 4 to 6 weeks .


The number of tumors visualized in WLC and PDD and histology of the TURB specimen was recorded to perform a statistical analysis comparing both the 2 arms .


A total of 151 patients were enrolled ( hexaminolevulinate , n = 72 ; control , n = 79 ) .


The number of visualized tumors did not increase with PDD in the first or second TURB .


During the second TURB , the residual tumor rate was not reduced in patients who had PDD during the first TURB .


No significant difference was observed regarding the pattern of category and grade , the size , and the recurrence and progression risks during either the first or the second TURB .


In the setting of primary non-muscle-invasive bladder cancer with positive results on urine cytology , performing a second TURB allows to diagnose residual tumor in approximately half of the cases .


This rate was not significantly reduced by the use of the PDD during the first TURB .


Recent guidance for the management of acute otorrhea in children with tympanostomy tubes is based on limited evidence from trials comparing oral antibiotic agents with topical antibiotics .


In this open-label , pragmatic trial , we randomly assigned 230 children , 1 to 10 years of age , who had acute tympanostomy-tube otorrhea to receive hydrocortisone-bacitracin-colistin eardrops ( 76 children ) or oral amoxicillin-clavulanate suspension ( 77 ) or to undergo initial observation ( 77 ) .


The primary outcome was the presence of otorrhea , as assessed otoscopically , 2 weeks after study-group assignment .


Secondary outcomes were the duration of the initial otorrhea episode , the total number of days of otorrhea and the number of otorrhea recurrences during 6 months of follow-up , quality of life , complications , and treatment-related adverse events .


Antibiotic-glucocorticoid eardrops were superior to oral antibiotics and initial observation for all outcomes .


At 2 weeks , 5 % of children treated with antibiotic-glucocorticoid eardrops had otorrhea , as compared with 44 % of those treated with oral antibiotics ( risk difference , -39 percentage points ; 95 % confidence interval [ CI ] , -51 to -26 ) and 55 % of those treated with initial observation ( risk difference , -49 percentage points ; 95 % CI , -62 to -37 ) .


The median duration of the initial episode of otorrhea was 4 days for children treated with antibiotic-glucocorticoid eardrops versus 5 days for those treated with oral antibiotics ( P < 0.001 ) and 12 days for those who were assigned to initial observation ( P < 0.001 ) .


Treatment-related adverse events were mild , and no complications of otitis media , including local cellulitis , perichondritis , mastoiditis , and intracranial complications , were reported at 2 weeks .


Antibiotic-glucocorticoid eardrops were more effective than oral antibiotics and initial observation in children with tympanostomy tubes who had uncomplicated acute otorrhea .


( Funded by the Netherlands Organization for Health Research and Development ; Netherlands Trial Register number , NTR1481 . )


We compare efficacy of ondansetron and metoclopramide with placebo for adults with undifferentiated emergency department ( ED ) nausea and vomiting .


A prospective , randomized , double-blind , placebo-controlled trial was conducted in 2 metropolitan EDs in Melbourne , Australia .


Eligible patients with ED nausea and vomiting were randomized to receive 4 mg intravenous ondansetron , 20 mg intravenous metoclopramide , or saline solution placebo .


Primary outcome was mean change in visual analog scale ( VAS ) rating of nausea severity from enrollment to 30 minutes after study drug administration .


Secondary outcomes included patient satisfaction , need for rescue antiemetic treatment , and adverse events .


Of 270 recruited patients , 258 ( 95.6 % ) were available for analysis .


Of these patients , 87 ( 33.7 % ) received ondansetron ; 88 ( 34.1 % ) , metoclopramide ; and 83 ( 32.2 % ) , placebo .


Baseline characteristics between treatment groups and recruitment site were similar .


Mean decrease in VAS score was 27 mm ( 95 % confidence interval [ CI ] 22 to 33 mm ) for ondansetron , 28 mm ( 95 % CI 22 to 34 mm ) for metoclopramide , and 23 mm ( 95 % CI 16 to 30 mm ) for placebo .


Satisfaction with treatment was reported by 54.1 % ( 95 % CI 43.5 % to 64.5 % ) , 61.6 % ( 95 % CI 51.0 % to 71.4 % ) , and 59.5 % ( 95 % CI 48.4 % to 69.9 % ) for ondansetron , metoclopramide , and placebo , respectively ; rescue medication was required by 34.5 % ( 95 % CI 25.0 % to 45.1 % ) , 17.9 % ( 95 % CI 10.8 % to 27.2 % ) , and 36.3 % ( 95 % CI 26.3 % to 47.2 % ) , respectively .


Nine minor adverse events were reported .


Reductions in nausea severity for this adult ED nausea and vomiting population were similar for 4 mg intravenous ondansetron , 20 mg intravenous metoclopramide , and placebo .


There was a trend toward greater reductions in VAS ratings and a lesser requirement for rescue medication in the antiemetic drug groups , but differences from the placebo group did not reach significance .


The majority of patients in all groups were satisfied with treatment .


Telemedicine holds great potential to improve access to care and to reduce barriers to treatment for military populations with posttraumatic stress disorder ( PTSD ) .


This study sought to integrate the use of telemedicine mental health treatment services by a community healthcare provider to military populations residing in a rural location and to compare the equivalency of cognitive behavioral therapy ( CBT ) administered via telemedicine and traditional face-to-face therapy .


Study subjects were men or women 18 years of age or older who had served in Operation Enduring Freedom ( OEF ) and/or Operation Iraqi Freedom ( OIF ) and were diagnosed with PTSD .


The 18 study subjects were randomized and provided 10 weekly therapy sessions of CBT .


Pre - and post-intervention assessments were conducted using the Clinician Administered PTSD Scale ( CAPS ) , Hamilton Anxiety Rating Scale ( HAM-A ) , Montgomery-Asberg Depression Rating Scale ( MADRS ) , Life Events Checklist , and SF-36v2 ( QualityMetric , Lincoln , RI ) Health Survey .


The CAPS , HAM-A , and MADRS each demonstrated lower scores , signifying improvement , and 69 % of subjects experienced a clinically significant change in the CAPS .


Patient satisfaction results indicated greater satisfaction for telemedicine as opposed to traditional face-to-face treatment .


Findings reveal a trend expressing the equivalence of telemedicine and face-to-face therapy when treating OEF/OIF veterans with PTSD among rural populations by a community provider .


It further demonstrates the successful collaboration between a community healthcare provider and the military healthcare system .


To test the effects of a school-based prevention programme on students ' smoking-related behaviour , attitudes and knowledge 6 months after implementation over 2 school-years has ended .


Two-arm prospective cluster randomised controlled trial with a follow-up survey 6 months after end of programme implementation , that is , 26 months after baseline .


45 public secondary schools from four federal states in Germany ( Bremen , Hesse , North Rhine-Westphalia , Schleswig-Holstein ) .


A total of 3444 students from 172 classes with a mean age of 10.37 years ( SD = 0.59 ) and 47.9 % girls at baseline .


Analysis sample with follow-up up data merged to baseline data comprises 2513 datasets ( 73 % ) .


` Eigenstndig werden 5 +6 ' , a school-based prevention programme for grades 5 and 6 to enhance substance-specific and general life skills , consisting of 14 units ( 90 min ) and two workshops ( 4-6 h ) being taught over a time period of 2 school-years by trained teachers .


Lifetime and current smoking , incidence of smoking in baseline never smokers , smoking-related knowledge , attitudes , perceived norms of smoking and self-efficacy to refuse cigarette offers were assessed in students .


6 months after the end of programme implementation , students of intervention classes showed significantly lower rates for lifetime smoking ( adjusted OR = 0.63 ; 95 % CI 0.41 to 0.96 ; p = 0.026 ) and incidence of smoking ( adjusted OR = 0.66 ; 95 % CI 0.43 to 1.00 ; p = 0.047 ) , a higher increase of smoking-related knowledge ( adjusted = 9.38 ; 95 % CI 6.73 to 12.04 ; p < 0.001 ) and a greater change in attitudes towards a more critical perception of risks and disadvantages of smoking ( adjusted = 0.10 ; 95 % CI 0.03 to 0.16 ; p = 0.002 ) .


No group differences were found for current smoking , perceived norms of smoking and self-efficacy to refuse cigarette offers .


Participation in the school-based prevention programme ` Eigenstndig werden 5 +6 ' may have small effects on smoking behaviour and attitudes and a moderate effect on smoking-related knowledge .


Current Controlled Trials ISRCTN99442407 .


Intrathecal morphine for caesarean delivery provides excellent postoperative analgesia but it is commonly associated with nausea and vomiting .


This prospective , randomized , double blind study was carried out to compare the effectiveness of a combination of dexamethasone and ondansetron with dexamethasone alone for prevention of postoperative nausea and vomiting ( PONV ) following intrathecal morphine injection for caesarean section .


A total of 108 parturients aged 18-40 years for elective caesarean section were randomized into 2 groups ( n = 54 ) to receive either intravenous dexamethasone 8 mg ( Group A ) or a combination of intravenous dexamethasone 8 mg and ondansetron 4 mg ( group B ) .


The study drug for each group consisted of 0.5 % hyperbaric bupivacaine and 0.2 mg morphine .


The primary outcome variables were postoperative nausea and vomiting ( PONV ) which were assessed for a period of 24 hours .


The patient 's vital signs were monitored and documented .


The incidence of nausea and vomiting was significantly reduced in patients who received a combination of dexamethasone and ondansetron compared with dexamethasone alone ( 9.3 % Vs 37 % , respectively , P = 0.003 ) .


This study showed that a combination of dexamethasone and ondansetron administered prophylactically significantly reduced the incidence of PONV in pregnant women on intrathecal morphine for caesarean section .


There is increasing evidence of Gleason score ( GS ) drift in prostatic core biopsies during the last two decades .


The ProtecT study is a randomized controlled study and provides an excellent cohort to study the effect of time , prostate-specific antigen ( PSA ) level , perineural invasion , tumour length and age on GS .


The ProtecT study recruited men in the United Kingdom between 1999 and 2010 .


The Gleason scores were grouped into four categories 3 + 3 , 3 + 4 , 4 + 3 and 4 + 4 for analysis .


Data from England between 2000 and 2012 were also available .


A total of 3282 biopsies containing cancer were analysed .


For each year of the ProtecT study , the odds of being diagnosed with a higher GS category increased by 4.9 % .


Higher GS was also associated with perineural invasion , increasing tumour length , age and PSA level .


While biopsy GS from England was incomplete , it also showed a marked decrease in GS five and six tumours during the same period .


There was GS drift from 3 + 3 to 3 + 4 with time in the ProtecT study , but there appeared to be no significant change in percentage of GS 4 + 3 or higher .


This drift was less dramatic when compared to GS in the rest of England .


Sleep problems are common in children with attention-deficit/hyperactivity disorder ( ADHD ) , yet little is known about sleep medication use in this population .


The aim of this study was to describe sleep medication use , as well as associated child and family characteristics in school-aged children with ADHD .


Sleep medication use was ascertained using a prospective parent-completed seven-night sleep and medication log .


Exposure variables included socio-demographic characteristics , total sleep problem severity ( Children 's Sleep Habits Questionnaire ) , ADHD severity and subtype ( ADHD Rating Scale IV ) , ADHD medication use , internalising and externalising co-morbidities ( Anxiety Disorders Interview Schedule for Children/Parent version IV ) and parent mental health ( Depression Anxiety Stress Scale ) .


Two hundred and fifty-seven children with ADHD participated and of these 57 ( 22 % ) were taking sleep medication ( melatonin 14 % and clonidine 9 % ) .


Sleep medication use was associated with combined-type ADHD and ADHD medication use .


The presence of co-occurring internalising and externalising co-morbidities was also associated with sleep medication use in ad hoc analyses .


Sleep medication use is common in children with ADHD and is associated with combined-type ADHD and use of ADHD medication .


Further research is needed on the broad functional benefits and long-term safety of sleep medication in this population .


Despite policy interest , an ethical imperative , and evidence of the benefits of patient decision support tools , the adoption of shared decision making ( SDM ) in day-to-day clinical practice remains slow and is inhibited by barriers that include culture and attitudes ; resources and time pressures .


Patient decision support tools often require high levels of health and computer literacy .


Option Grids are one-page evidence-based summaries of the available condition-specific treatment options , listing patients ' frequently asked questions .


They are designed to be sufficiently brief and accessible enough to support a better dialogue between patients and clinicians during routine consultations .


This paper describes a study to assess whether an Option Grid for osteoarthritis of the knee ( OA of the knee ) facilitates SDM , and explores the use of Option Grids by patients disadvantaged by language or poor health literacy .


This will be a stepped wedge exploratory trial involving 72 patients with OA of the knee referred from primary medical care to a specialist musculoskeletal service in Oldham .


Six physiotherapists will sequentially join the trial and consult with six patients using usual care procedures .


After a period of brief training in using the Option Grid , the same six physiotherapists will consult with six further patients using an Option Grid in the consultation .


The primary outcome will be efficacy of the Option Grid in facilitating SDM as measured by observational scores using the OPTION scale .


Comparisons will be made between patients who have received the Option Grid and those who received usual care .


A Decision Quality Measure ( DQM ) will assess quality of decision making .


The health literacy of patients will be measured using the REALM-R instrument .


Consultations will be observed and audio-recorded .


Interviews will be conducted with the physiotherapists , patients and any interpreters present to explore their views of using the Option Grid .


Option Grids offer a potential solution to the barriers to implementing traditional decision aids into routine clinical practice .


The study will assess whether Option Grids can facilitate SDM in day-to-day clinical practice and explore their use with patients disadvantaged by language or poor health literacy .


Current Controlled Trials ISRCTN94871417 .


The ingestion of carbohydrate ( CHO ) before and during exercise and at halftime is commonly recommended to soccer players for maintaining blood glucose concentrations throughout match play .


However , an exercise-induced rebound glycemic response has been observed in the early stages of the second half of simulated soccer-specific exercise when CHO-electrolyte beverages were consumed regularly .


Therefore , the metabolic effects of CHO beverage consumption throughout soccer match play remain unclear .


To investigate the blood glucose and blood lactate responses to CHOs ingested before and during soccer match play .


Crossover study .


Applied research study .


Ten male outfield academy soccer players ( age = 15.6 0.2 years , height = 1.74 0.02 m , mass = 65.3 1.9 kg , estimated maximal oxygen consumption = 58.4 0.8 mLkg ( -1 ) min ( -1 ) ) .


Players received a 6 % CHO-electrolyte solution or an electrolyte ( placebo ) solution 2 hours before kickoff , before each half ( within 10 minutes ) , and every 15 minutes throughout exercise .


Blood samples were obtained at rest , every 15 minutes during the match ( first half : 0-15 , 15-30 , and 30-45 minutes ; second half : 45-60 , 60-75 , and 75-90 minutes ) and 10 minutes into the halftime break .


Metabolic responses ( blood glucose and blood lactate concentrations ) and markers of exercise intensity ( heart rate ) were recorded .


Supplementation influenced the blood glucose response to exercise ( time treatment interaction effect : P .05 ) , such that glucose concentrations were higher at 30 to 45 minutes in the CHO than in the placebo condition .


However , in the second half , blood glucose concentrations were similar between conditions because of transient reductions from peak values occurring in both trials at halftime .


Blood lactate concentrations were elevated above those at rest in the first 15 minutes of exercise ( time-of-sample effect : P < .001 ) and remained elevated throughout exercise .


Supplementation did not influence the pattern of response ( time treatment interaction effect : P = .49 ) .


Ingestion of a 6 % CHO-electrolyte beverage before and during soccer match play did not benefit blood glucose concentrations throughout the second half of exercise .


The aim of this study was to compare the effectiveness in the medium term between low and high doses of triamcinolone hexacetonide used in intra-articular injection in medium-sized joints of rheumatoid arthritis ( RA ) patients .


A randomized double-blind study was carried out in rheumatoid arthritis patients with wrist painful refractory synovitis .


Sixty wrists were included and randomized to receive low dose ( 20 mg ) or high dose ( 40 mg ) .


The outcomes assessed in T0 , T1 , T4 , T8 , and T12 weeks were visual analog scale for pain and for swelling , chronic disease activity index , goniometry , simplified Stanford Health Assessment Questionnaire , and side effects .


Baseline mean ( standard deviation ) values were pain visual analog scale of 6.1 ( 1.6 ) and 6.3 ( 1.7 ) , P = 0.562 ; swelling visual analog scale of 5.9 and 6.4 , P = 0.466 ; chronic disease activity index of 17.8 and 16.8 , P = 0.366 ; and Health Assessment Questionnaire of 0.8 and 0.7 , P = 0.238 , in the high - and low-dose groups , respectively .


Both groups improved pain and swelling assessed by the visual analog scale , P < 0.001 , in the intragroup analysis .


Chronic disease activity index , goniometry , and Health Assessment Questionnaire also improved equally over time in both groups in the intragroup analysis ( P < 0.001 , 0.001 , and 0.002 , respectively ) .


No serious side effects were detected .


High and low triamcinolone hexacetonide doses had good effectiveness in wrist-blinded intra-articular injection of rheumatoid arthritis patients , without statistical difference between them .


We assessed the impact of a noise-reduction program in a pediatric operating theatre .


Adverse effects from noise pollution in theatres have been demonstrated .


In 156 operations spatially resolved , sound levels were measured before and after a noise-reduction program on the basis of education , rules , and technical devices ( Sound Ear ) .


Surgical complications were recorded .


The surgeon 's biometric ( saliva cortisol , electrodermal activity ) and behavioral stress responses ( questionnaires ) were measured and correlated with mission protocols and individual noise sensitivity .


Median noise levels in the control group versus the interventional group were reduced by -3 3 dB ( A ) ( 63 vs 59 dB ( A ) , P < 0.001 ) with a grossly decreased number of peaks greater than 70 dB ( A ) ( n = -61 / hour , P < 0.01 ) .


The intervention significantly reduced non-operation-related noise .


The incidence of postoperative complications was significantly lower in patients of the intervention group ( n = 10/56 vs 20/58 control ; P < 0.05 ) .


`` Responders , '' surgeons with an above-average noise sensitivity ( correlation r = -0.6 for the work subscale of the NoiseQ questionnaire , P < 0.05 ) , experienced improved intrateam communication , a decrease in disturbing conversations and sudden noise peaks ( P < 0.05 ) .


Biometrically , the intervention decreased both the surgeon 's pre - to postoperative rise in cortisol by approximately 20 % and the surgeon 's electrodermal potentials of greater than 15 S , indicating severe stress by 60 % ( P > 0.05 ) .


Spontaneous noise during pediatric operations attains the magnitude of a lawn mower and peaks resemble a passing truck .


The sound intensity could be reduced by 50 % by specific measures .


This reduction was associated with a significantly lowered number of postoperative complications .


The surgeon 's benefits are idiosyncratic with `` responders '' experiencing marked improvements .


Asthma is a complex disease presenting with variable symptoms which are sometimes hard to control .


The purpose of the study was to describe the prevalence of asthma symptoms , use of asthma medications and allergic sensitization in subjects with asthma .


We also related those indices to the level of asthma control , lung function and in particular , cough .


An extensive questionnaire was sent to randomly selected adults from the West Sweden region .


Clinical examinations and interview were performed in a subset .


Of the participants , 744 were defined as having an ongoing asthma - reported ever having asthma or physician diagnosed asthma and one of the following - use of asthma medications , recurrent wheeze or attacks of shortness of breath with or without wheeze in the last 12months .


A respiratory disease-free control group of 847 subjects was also described .


According to GINA guidelines , 40.6 % of the asthmatics had partly controlled and 17.8 % had uncontrolled asthma .


Asthmatic subjects reported significantly more symptoms in the last 12months than the control group - wheezing ( 79.4 vs 9.2 % ) , shortness of breath ( 36.1 vs 2.5 % ) , wheezing with shortness of breath ( 58.7 vs 1.3 % ) .


Important complaints were morning cough ( 42.5 vs 15.5 % ) , cough with sputum production ( 36.1 vs 6.8 % ) and longstanding cough ( 32.5 vs 11.1 % ) , which bothered two thirds of the uncontrolled and one third of partly controlled subjects .


Asthma medications were used by 87.5 % of the asthmatics , although around 30 % of them who had insufficiently controlled disease used only short-acting beta-agonists .


Asthmatics also had lower lung function , reacted to lower doses of methacholine that the controls and 13.6 % of them had a FEV1/FVC ratio below 0.7 .


Allergic rhinitis was reported by 73.8 % of the asthmatics and they were more frequently sensitized to several common allergens .


Approximately 60 % of asthmatics from this population-based study had insufficiently controlled asthma and persistent complaints , despite a high use of asthma medications .


These self-reported symptoms were supported by clinical examination data .


Increased cough frequency is an indicator of a more severe and difficult to control disease and should be considered when asthma is characterized .


Current heart failure ( HF ) risk prediction models do not consider how individual patient assessments occur in incremental steps ; furthermore , each additional diagnostic evaluation may add cost , complexity , and potential morbidity .


Using a cohort of well-treated ambulatory HF patients with reduced ejection fraction who had complete clinical , laboratory , health-related quality of life , imaging , and exercise testing data , we estimated incremental prognostic information provided by 5 assessment categories , performing an additional analysis on those with available N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) levels .


We compared the incremental value of each additional assessment ( quality of life screen , laboratory testing , echocardiography , and exercise testing ) to baseline clinical assessment for predicting clinical outcomes ( all-cause mortality , all-cause mortality/hospitalization , and cardiovascular death/HF hospitalizations ) , gauging incremental improvements in prognostic ability with more information using area under the curve and reclassification improvement ( net reclassification index ) , with and without NT-proBNP availability .


Of 2331 participants , 1631 patients had complete clinical data ; of these , 1023 had baseline NT-proBNP .


For prediction of all-cause mortality , models with incremental assessments sans NT-proBNP showed improvements in C-indices ( 0.72 [ clinical model alone ] -0.77 [ complete model ] ) .


Compared with baseline clinical assessment alone , net reclassification index improved from 0.035 ( w/laboratory data ) to 0.085 ( complete model ) .


These improvements were significantly attenuated for models in the subset with measured NT-proBNP data ( c-indices : 0.80 [ w/laboratory data ] -0.81 [ full model ] ) ; net reclassification index improvements were similarly marginal ( 0.0910.096 ) ; prediction of other clinical outcomes had similar findings .


In chronic HF patients with reduced ejection fraction , the marginal benefit of complex prognostic evaluations should be weighed against potential patient discomfort and cost escalation .


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


Unique identifier : NCT00047437 .


To evaluate the curative effect and safety of Bushen Qiangji Decoction ( BQD ) and Qingre Qiangji Decoction ( QQD ) in treating ankylosing spondylitis ( AS ) patients , and to verify the clinical utility of AS syndrome differentiation and treatment scheme [ Shen-deficiency induced stasis obstruction syndrome ( SDISOS ) and dampness-heat obstruction syndrome ( DHOS ) being two basic syndrome types , Shen invigorating blood activating method ( SIBAM ) and heat clearing dampness resolving method ( HCDRM ) being two basic treatment methods ] .


Totally 354 AS patients of SDISOS and DHOS were randomly assigned to the treatment group and the control group using a multi-center randomized , positive drug parallel-controlled clinical trail .


Patients in treatment group were treated by BQD or QQD according to syndrome typing , while those in the control group took Sulfasalazine enteric-coated tablet ( SECT ) , 24 weeks as one therapeutic course .


After treatment , the clinical efficacy was evaluated by using ASAS20 standard ( set by Asessment in Ankylosing Spondylitis working group ) , Chinese medical efficacy evaluation standards , and BASDAI , BASFI , BASMI , night-pain index , spinal pain index , PGA , C-reactive protein ( CRP ) , and erythrocyte sedimentation rate ( ESR ) .


After 24 weeks of treatment by BQD or QQD , ASAS20 standard rate was 86.75 % in the treatment group , and the total effective rate of Chinese medical syndrome was 85.47 % .


They could significantly reduce patients ' integrals of Chinese medical syndrome , BASDAI , BASFI , BASMI , night-pain index , spinal pain index , and PGA ( all P < 0.01 ) .


QQD and BQD got confirmable clinical effects in treating AS , providing strong evidence of evidence-based medicine for syndrome differentiation and treatment of AS .


The diagnosis of incurable cancer may evoke physiological arousal in patients .


Physiological arousal can negatively impact patients ' recall of information provided in the medical consultation .


We aim to investigate whether clinicians ' affective communication during a bad news consultation will decrease patients ' physiological arousal and will improve recall .


Healthy women ( N = 50 ) , acting as analogue patients , were randomly assigned to watch one out of the two versions of a scripted video-vignette of a bad news consultation in which clinician 's communication differed : standard vs. affective communication .


Participants ' skin conductance levels were obtained during video-watching , and afterwards their recall was assessed .


While the diagnosis increased skin conductance levels in all analogue patients , skin conductance levels during the remainder of the consultation decreased more in the affective communication condition than in the standard condition .


Analogue patients ' recall was significantly higher in the affective condition .


Breaking bad news evokes physiological arousal .


Affective communication can decrease this evoked physiological arousal and might be partly responsible for analogue patients ' enhanced information recall .


Although our findings need to be translated to clinical patients , they suggest that clinicians need to deal with patients ' emotions before providing additional medical information .


To compare the efficacy of British Thoracic Society and American Thoracic Society guidelines for reintroduction of anti-tuberculous therapy after drug-induced liver injury , and to assess the ease of administration of each guideline on a scale of 1-10 .


The randomised prospective interventional study was conducted at the Department of Medicine and Pulmonology , Dow University of Health Sciences , Karachi , from December 2011 to November 2013 .


Patients with anti-tuberculous therapy drug-induced liver injury were selected .


Hepatotoxic anti-tuberculous therapy was stopped and modified anti-tuberculous therapy was started .


Patients were followed weekly till clinical and biochemical parameters got stabilised .


After stabilisation , the patients were randomised to one of the two groups to receive re-introduction of anti-tuberculous therapy under the guidelines of British Thoracic Society ( Group I ) or those of American Thoracic Society ( Group II ) .


Means of the groups were analysed by Student 's t test and proportions were compared by chi-square test .


Multivariate analysis was done for age , body mass index and serum albumin for recurrence of drug-induced liver injury after the re-introduction .


P value < 0.05 was taken as significant .


Of the total 325 patients , 163 ( 50.15 % ) were in Group I , while 162 ( 49.84 % ) were in Group II .


The frequency of recurrence of drug-induced liver injury in Group I was 16 ( 9.8 % ) and in Group II it was 18 ( 11.1 % ) .


There was no statistically significant difference between the two groups ( p < 0.7 ) .


Age was positively related with drug-induced liver injury , while body mass index and serum albumin were negatively associated .


There was no significant difference between the two major guidelines though the American Thoracic Society guideline was easier to follow .


Although the use of a dynamic hip screw ( DHS ) is considered to be the preferred treatment for intertrochanteric fractures , the external fixation device could produce clinical outcomes comparable to the outcomes obtained with conventional treatment .


Furthermore , because external fixation is minimally invasive , we expected a lower rate of morbidity .


Therefore , we compared the two treatments in a clinical trial of elderly patients with intertrochanteric fracture .


60 elderly high-risk patients with an average age of 78 years were treated for intertrochanteric fracture , resulting from a low energy trauma .


Patients were randomly divided in two groups regarding to treatment .


In Group A the patients were treated with DHS , while in Group B were treated with external fixator .


The fixator was well accepted and no patient had significant difficulties while sitting or lying .


The average intraoperative time was 73 min in Group A and 15 min in Group B ( p < 0.05 ) .


27 patients of Group A need blood transfusion postoperatively and none in Group B ( p < 0.05 ) .


The mean duration of hospitalization in Group A and Group B was 8.4 and 2.2 days , respectively ( p < 0.05 ) .


9 of patients Group B had pin-track infection grade 2 that all were treated by oral antibiotics .


There were no differences in comorbidities , quality of reduction , screw cut out , bed sore and HHS between the two groups .


Treatment with external fixator is an effective treatment for intertrochanteric fractures in elderly highrisk patients .


The advantages include quick and simple application , minimal blood loss , less radiation exposure , adequate fixation , pain reduction , early discharge from hospital , low costs and favourable functional outcomes .


Constipation is often characterized by slow colonic transit , but the relationship between colonic transit time ( CTT ) and symptoms is unclear .


The aims of this study were to investigate the effect of prucalopride , a 5-hydroxytryptamine receptor-4 agonist , on CTT and assess the relationship between CTT and symptoms .


This was an integrated analysis of three randomized , placebo-controlled , phase 2 dose-finding trials of prucalopride in patients with chronic constipation ( ClinicalTrials.gov identifiers : NCT00617513 ; NCT00631813 ; and NCT00596596 ) .


Measurements of CTT were analyzed using radio-opaque markers at the start and end ( 4 or 12 weeks ) of treatment .


At these visits , patients assessed the presence and severity of their symptoms .


In total , 280 patients had CTT measurements before and at the end of treatment and were included in the analysis .


Their mean age was 43 years , 93 % were women , and mean duration of constipation was 19 years .


After a once daily treatment with prucalopride 2 mg ( n = 98 ) and 4 mg ( n = 70 ) , CTT was reduced by 12.0 h ( 95 % confidence interval ( CI ) : -18.9 , -5.1 ) and 13.9 h ( 95 % CI : -20.5 , -7.4 ) , respectively ; CTT increased by 0.5 h ( 95 % CI : -4.5 , 5.5 ) with placebo ( n = 112 ) .


At the end of the trial , symptoms including bloating/flatulence/distension and straining were rated as severe or very severe by a higher proportion of patients with slow or very slow CTT ( > 48 h ) than by those with normal CTT .


There was a clear relationship between increased CTT and increased symptom severity in patients with chronic constipation .


Treatment with prucalopride accelerated CTT in these individuals .


Despite considerable use of make your own ( MYO ) cigarettes worldwide and increasing use in the United States , relatively little is known about how these cigarettes are smoked and the resultant toxicant exposure .


In a laboratory study , we compared two types of MYO cigarettes-roll your own ( RYO ) and personal machine made ( PMM ) - with factory-made ( FM ) cigarettes in three groups of smokers who exclusively used RYO ( n = 34 ) , PMM ( n = 23 ) , or FM ( n = 20 ) .


Within each group , cigarettes were smoked in three conditions : ( i ) after confirmed overnight tobacco abstinence ; ( ii ) in an intense smoking paradigm ; and ( iii ) without restrictions .


All cigarettes were smoked ad lib through a smoking topography unit .


Plasma nicotine significantly increased after cigarettes in all conditions except PMM in the intense smoking paradigm .


Puff volume , puff duration , total puff volume , and puff velocity did not differ between cigarette types but the puffs per cigarette and time to smoke were significantly smaller for RYO compared with PMM and FM .


Regardless of the cigarette , participants consumed the first three puffs more vigorously than the last three puffs .


Despite the belief of many of their consumers , smoking MYO cigarettes is not a safe alternative to FM cigarettes .


Like FM , MYO cigarettes expose their users to harmful constituents of tobacco smoke .


Despite differences in size and design their puffing profiles are remarkably similar .


These data are relevant to health and regulatory considerations on the MYO cigarettes .


Declining cognitive function is relatively common and increasingly prevalent .


Studies have shown that different nutrients ( e.g. , Ginkgo biloba and vitamin E ) appear to be effective at improving memory and concentration , while less is known about their effect on immunity .