All children achieved satisfactory anxiolysis at 30 min .


Group I fared significantly better than GroupII on mask acceptance ( 100 % in Group I vs. 80 % in Group II ; P = 0.024 ) , drug acceptance ( 93 % vs. 13 % ; P < 0.001 ) and proportion of patients with satisfactory wake up scores ( 100 % vs. 53 % ; P < 0.001 ) .


Group II patients had significantly faster onset of sedation ( median 10 min vs. 15 min ; P < 0.05 ) but not that of anxiolysis compared to Group-I ( median 10 min for both groups ; P > 0.05 ) .


Side effects were significantly more frequent in Group II .


Though intranasal midazolam produced faster sedation , both the drugs produced satisfactory anxiolysis at 30 min .


Few studies have investigated factors influencing participation rates for minority children with a chronic disease in clinical trials .


The Silent Cerebral Infarct Multi-Center Clinical ( SIT ) Trial provides an opportunity to study the impact of demographic and socio-economic factors on randomization in a clinical trial among Black children .


Our primary objective was to characterize the factors associated with successful randomization of children with sickle cell disease ( SCD ) and silent cerebral infarct ( SCI ) in the SIT Trial after initial consent .


Differences in socio-economic and demographic variables , family history and disease-related variables were determined between eligible participants who were successfully randomized and those who were not randomized following initial consent .


Head of household educational level and family income were examined separately for US versus non-US sites .


Of 1,176 children enrolled in the SIT Trial , 1,016 ( 86 % ) completed screening .


Of 208 ( 20 % ) children with qualifying SCI on pre-randomization MRI , 196 ( 94 % ) were successfully randomized .


There were no differences in socio-economic , demographic , or disease-related variables between children who were or were not randomized .


Participants from non-US sites were more likely to be randomized ( 22 % vs. 12 % , P = 0.011 ) ; although , randomization by country was associated with neither head of household education nor family income .


In the SIT Trial , acceptance of random allocation was not associated with socio-economic or demographic factors .


Although these factors may represent barriers for some participants , they should not bias investigators caring for children with SCD in their approach to recruitment for clinical trial participation .


Acute pain is common during the endotracheal extubation period , and is related to complications and adverse outcomes .


Patients with delayed extubation after craniotomy are vulnerable to pain and complications of extubation .


However , pain control during extubation is still inadequate .


Remifentanil , a new opioid with rapid onset and short duration of action , provides adequate analgesia during procedures with minimal effect of respiratory depression .


The study is a prospective , randomised , double-blinded , controlled parallel-group design .


Patients with delayed extubation after intracranial surgery are screened daily .


Adult patients ready for extubation are enrolled and assigned randomly to one of the two treatment study groups , labelled as the ` Remi group ' or ` Saline group ' .


Patients in the Remi group receive an intravenous bolus dose of remifentanil 0.5 g/kg over 60s followed by a continuous infusion 0.05 g/kg/min for 20min .


Patients in the Saline group receive an intravenous infusion of 0.9 % sodium chloride at a volume and rate equal to that of remifentanil .


Pain intensity is measured by the visual analogue scale ( VAS ) pain score .


Adverse events during drug infusion are documented and reported .


Patients will be followed up until hospital discharge , death or 60days after the trial intervention on a first come , first served basis .


Details of the incidence of reintubation and reoperation within 72h after extubation , length of stay in the intensive care unit and hospital and mortality are collected .


The primary end point is the incidence of severe pain ( defined as a VAS pain score more than 5cm ) during the periextubation period ( defined as the period of time from immediately before extubation to 20min after extubation ) .


The study was approved by the Institutional Review Board ( IRB ) of the Beijing Tiantan Hospital , Capital Medical University .


The study findings will be disseminated through peer-reviewed publications and conference presentations .


ClinicalTrials ( NCT ) : ChiCTR-PRC-13003879 .


Virtually no clinical trials for smoking cessation have been undertaken in bipolar disorder .


Varenicline has shown efficacy for smoking cessation , but warnings about neuropsychiatric adverse events have been issued .


We assessed the efficacy and safety of varenicline in euthymic bipolar subjects motivated to quit smoking .


Clinically stable adult patients with DSM-IV bipolar disorder ( n = 60 ) who smoked 10 cigarettes per day were randomized to a 3-month , double-blind , placebo-controlled varenicline trial and a 3-month follow-up .


Study enrollment was completed from February 2010 through March 2013 .


Varenicline was dosed using standard titration , and smoking cessation counseling was provided to all patients .


The primary outcome was defined as a 7-day point prevalence of self-reported no smoking verified by expired carbon monoxide level < 10 ppm at 12 weeks .


Psychopathology and side-effects were assessed at each visit .


At 3 months ( end of treatment ) , significantly more subjects quit smoking with varenicline ( n/n = 15/31 , 48.4 % ) than with placebo ( n/n = 3/29 , 10.3 % ) ( OR = 8.1 ; 95 % CI , 2.03-32 .5 ; P < .002 ) .


At 6 months , 6 of 31 varenicline-treated subjects ( 19.4 % ) remained abstinent compared to 2 of 29 ( 6.90 % ) assigned to placebo ( OR = 3.2 ; 95 % CI , 0.60-17 .6 ; P = .17 ) .


Psychopathology scores remained stable .


Ten serious adverse events occurred ( n = 6 , varenicline ; n = 4 , placebo ) .


Abnormal dreams occurred significantly more often in varenicline-treated subjects ( n/n = 18/31 , 61.3 % ) than in those receiving placebo ( n/n = 9/29 , 31 % ; Fisher exact test , P = .04 ) .


Eight varenicline-treated and 5 placebo-assigned subjects expressed fleeting suicidal ideation , a nonsignificant difference .


Varenicline shows efficacy for initiating smoking cessation in bipolar patients , but medication trials of longer duration are warranted for maintaining abstinence .


Vigilance for neuropsychiatric adverse events is prudent when initiating varenicline for smoking cessation in this patient population .


ClinicalTrials.gov identifier : NCT01010204 .


To examine the stability of severe pediatric obesity relative to moderate obesity and associated changes in cardiometabolic risk from the beginning of 6th to the end of 8th grade .


Participants in HEALTHY , a multi-site , cluster randomized school-based study designed to mitigate risk for type 2 diabetes , completed standardized assessments of height , weight , glucose , insulin , lipids , and blood pressure at the beginning of 6th grade and the end of 8th grade .


Youth were classified as moderately obese ( 100-119 % of the 95th percentile of BMI for age and gender ) or severely obese ( 120 % of the 95th percentile of BMI for age and gender ) .


Generalized linear mixed models ( GLMM ) that controlled for relevant covariables were used to examine the relation between baseline demographic and cardiometabolic risk factors and BMI status , as well as changes in relative weight category and risk factors during middle school .


Severe obesity was more likely to endure over the course of middle school than was moderate obesity , and was associated with significantly higher levels of cardiometabolic risk .


Research with a specific focus on understanding , preventing , and treating severe obesity in children is warranted .


Infections caused by carbapenemase-producing Enterobacteriaceae are increasing worldwide , especially in ICUs , and have been associated with high mortality rates .


However , unequivocally demonstrating causality of such infections to death is difficult in critically ill patients because of potential confounding and competing events .


Here , we quantified the effects of carbapenemase-producing Enterobacteriaceae carriage on patient outcome in two Greek ICUs with carbapenemase-producing Enterobacteriaceae endemicity .


Observational cohort study .


Two ICUs with carbapenemase-producing Enterobacteriaceae endemicity .


Patients admitted to the ICU with an expected length of ICU stay of at least 3 days were included .


None .


Carbapenemase-producing Enterobacteriaceae colonization was established through screening in perineum swabs obtained at admission and twice weekly and inoculated on chromogenic plates .


Detection of carbapenemases was performed phenotypically , with confirmation by polymerase chain reaction .


Risk factors for ICU mortality were evaluated using cause-specific hazard ratios and subdistribution hazard ratios , with carbapenemase-producing Enterobacteriaceae colonization as time-varying covariate .


One thousand seven patients were included , 36 ( 3.6 % ) were colonized at admission , and 96 ( 9.5 % ) acquired carbapenemase-producing Enterobacteriaceae colonization during ICU stay , and 301 ( 29.9 % ) died in ICU .


Of 132 carbapenemase-producing Enterobacteriaceae isolates , 125 ( 94.7 % ) were Klebsiella pneumoniae and 74 harbored K. pneumoniae carbapenemase ( 56.1 % ) , 54 metallo -- lactamase ( 40.9 % ) , and four both ( 3.0 % ) .


Carbapenemase-producing Enterobacteriaceae colonization was associated with a statistically significant increase of the subdistribution hazard ratio for ICU mortality ( subdistribution hazard ratio = 1.79 ; 95 % CI , 1.31-2 .43 ) , not explained by an increased daily hazard of dying ( cause-specific hazard ratio for death = 1.02 ; 95 % CI , 0.74-1 .41 ) , but by an increased length of stay ( cause-specific hazard ratio for discharge alive = 0.73 ; 95 % CI , 0.51-0 .94 ) .


Other risk factors in the subdistribution hazard model were Acute Physiology and Chronic Health Evaluation II score ( subdistribution hazard ratio = 1.13 ; 95 % CI , 1.11-1 .15 ) , female gender ( subdistribution hazard ratio = 1.29 ; 95 % CI , 1.02-1 .62 ) , presence of solid tumor ( subdistribution hazard ratio = 1.54 ; 95 % CI , 1.15-2 .06 ) , hematopoietic malignancy ( subdistribution hazard ratio = 1.61 ; 95 % CI , 1.04-2 .51 ) , and immunodeficiency ( subdistribution hazard ratio = 1.59 ; 95 % CI , 1.11-2 .27 ) .


Patients colonized with carbapenemase-producing Enterobacteriaceae have on average a 1.79 times higher hazard of dying in ICU than noncolonized patients , primarily because of an increased length of stay .


The extubation phase is an extremely critical moment in patients who have undergone orthotopic liver transplantation , who do not always have the advantage of long-lasting positive-pressure ventilation and positive expiratory end pressure ; these factors can lead to splanchnic venous congestion , and this is why a rapid extubation can represent a great benefit for the graft .


The aim of this study was to compare the adaptive support ventilation ( ASV ) mode with the standard mode of weaning in our intensive care unit , synchronized intermittent mandatory ventilation with pressure support ( P-SIMV ) , in patients who received orthotopic liver transplantation .


ASV is a positive-pressure mode , in which pressure level and respiratory rate are automatically adjusted according to measured lung dynamics at each breath .


Eligible patients were assigned to either ASV or P-SIMV group .


The weaning protocol was based on the individual respiratory activity and structured in 4 different phases .


The average length of intubation was significantly shorter in the ASV group than in the P-SIMV group ( 9013 vs 15322 minutes , P = .05 ) .


The total modifications to the ventilator settings were significantly larger in the P-SIMV group ( 1.51 vs 62 ; P = .003 ) .


Our results suggest that although both procedures are safe and easy to apply , ASV is superior in terms of weaning times , and it simplifies respiratory management .


The better patient-machine interaction in ASV has been highlighted by other authors for different clusters of patients .


In the international randomised phase 3 CORRECT trial ( NCT01103323 ) , regorafenib significantly improved overall survival versus placebo in patients with treatment-refractory metastatic colorectal cancer .


Of the 760 patients in CORRECT , 111 were Asian ( mostly Japanese ) .


This phase 3 trial was done to assess regorafenib in a broader population of Asian patients with refractory metastatic colorectal cancer than was studied in CORRECT .


In this randomised , double-blind , placebo-controlled , parallel-group , phase 3 trial done in 25 hospitals in mainland China , Hong Kong , South Korea , Taiwan , and Vietnam , we recruited Asian patients aged 18 years or older with progressive metastatic colorectal cancer who had received at least two previous treatment lines or were unable to tolerate standard treatments .


Patients had to have an Eastern Cooperative Oncology Group performance status of 0 or 1 , life expectancy of at least 3 months , and adequate bone marrow , liver , and renal function , without other uncontrolled medical disorders .


We randomly allocated patients ( 2:1 ; with a computer-generated unicentric randomisation list [ prepared by the study funder ] and interactive voice response system ; block size of six ; stratified by metastatic site [ single vs multiple organs ] and time from diagnosis of metastatic disease [ < 18 months vs 18 months ] ) to receive oral regorafenib 160 mg once daily or placebo on days 1-21 of each 28 day cycle ; patients in both groups were also to receive best supportive care .


Participants , investigators , and the study funder were masked to treatment assignment .


The primary endpoint was overall survival , and we analysed data on an intention-to-treat basis .


This trial is registered with ClinicalTrials.gov , number NCT01584830 .


Between April 29 , 2012 , and Feb 6 , 2013 , we screened 243 patients and randomly assigned 204 patients to receive either regorafenib ( 136 [ 67 % ] ) or placebo ( 68 [ 33 % ] ) .


After a median follow-up of 74 months ( IQR 43-122 ) , overall survival was significantly better with regorafenib than it was with placebo ( hazard ratio 055 , 95 % CI 040-077 , one-sided p = 000016 ; median overall survival 88 months [ 95 % CI 73-98 ] in the regorafenib group vs 63 months [ 48-76 ] in the placebo group ) .


Drug-related adverse events occurred in 132 ( 97 % ) of 136 regorafenib recipients and 31 ( 46 % ) of 68 placebo recipients .


The most frequent grade 3 or higher regorafenib-related adverse events were hand-foot skin reaction ( 22 [ 16 % ] of 136 patients in the regorafenib group vs none in the placebo group ) , hypertension ( 15 [ 11 % ] vs two [ 3 % ] of 68 patients in the placebo group ) , hyperbilirubinaemia ( nine [ 7 % ] vs one [ 1 % ] ) , hypophosphataemia ( nine [ 7 % ] vs none ) , alanine aminotransferase concentration increases ( nine [ 7 % ] vs none ) , aspartate aminotransferase concentration increases ( eight [ 6 % ] vs none ) , lipase concentration increases ( six [ 4 % ] vs one [ 1 % ] ) , and maculopapular rash ( six [ 4 % ] vs none ) .


Drug-related serious adverse events occurred in 12 ( 9 % ) patients in the regorafenib group and three ( 4 % ) in the placebo group .


This phase 3 trial is the second to show an overall survival benefit with regorafenib compared with placebo in patients with treatment-refractory metastatic colorectal cancer , substantiating the role of regorafenib as an important treatment option for patients whose disease has progressed after standard treatments .


In this trial , preceding standard treatments did not necessarily include targeted treatments .


Adverse events were generally consistent with the known safety profile of regorafenib in this setting .


Bayer HealthCare Pharmaceuticals .


Lumbar discectomy and laminectomy in patients with intervertebral disc herniation ( IDH ) is common , with variable reported reoperation rates .


Our study examined which baseline characteristics might be risk factors for reoperation and compared outcomes between patients who underwent reoperation and those who did not .


We performed a retrospective subgroup analysis of patients from the IDH arm of the Spine Patient Outcomes Research Trial ( SPORT ) randomized and observational cohorts .


We analyzed baseline characteristics and outcomes of patients who underwent reoperation and those who did not with use of data collected from enrollment through eight-years of follow-up after surgery .


Follow-up times were measured from the time of surgery , and baseline covariates were updated to the follow-up immediately preceding the time of surgery for outcomes analyses .


At eight years , the reoperation rate was 15 % ( 691 no reoperation ; 119 reoperation ) .


Sixty-two percent of these patients underwent reoperation because of a recurrent disc herniation ; 25 % , because of a complication or other factor ; and 11 % , because of a new condition .


The proportion of reoperations that were performed for a recurrent disc herniation ranged from 58 % to 62 % in the individual years .


Older patients were less likely to have reoperation ( p = 0.015 ) , as were patients presenting with asymmetric motor weakness at baseline ( p = 0.0003 ) .


Smoking , diabetes , obesity , Workers ' Compensation , and clinical depression were not associated with a greater risk of reoperation .


Scores on the Short Form ( SF ) -36 for bodily pain and physical functioning , the Oswestry Disability Index ( ODI ) , and the Sciatica Bothersomeness Index as well as satisfaction with symptoms had improved less at the time of follow-up in the reoperation group ( p < 0.001 ) .


In patients who underwent surgery for IDH , the overall reoperation rate was 15 % at the eight-year follow-up .


Patients of older age and patients presenting with asymmetric motor weakness were less likely to undergo a reoperation .


Less improvement in patient-reported outcomes was noted in the reoperation group .


Asthma is a common disease that affects people of all ages and has significant morbidity and mortality .


Poor outcomes and health disparities related to asthma result in part from the difficulty of disseminating new evidence and care delivery methods such as shared decision making ( SDM ) into clinical practice .


This non-blinded study will randomize 30 primary care clinics in NC stratified by four PBRNs .


We will test dissemination across these practices using a facilitator-led participatory approach to dissemination ( FLOW ) , a novel method of participatory dissemination involving key principles of community-based participatory research , and a more typical `` lunch and learn '' dissemination method .


Specifically , we will use cluster randomization to assign each of the 30 practices to one of three arms : ( 1 ) control , no dissemination ; ( 2 ) traditional dissemination , one didactic session a year and distribution of educational material ; and ( 3 ) FLOW dissemination .


We hypothesize that at the unit of randomization , the clinic , patients in the FLOW dissemination arm will be more likely to share in their treatment decisions compared to patients in the traditional dissemination or control arms .


All outcomes will be measured at the level of the clinic .


Adoption of the SDM approach will be evaluated by 1 ) asthma exacerbations , 2 ) level of patient involvement in the decision making process , and 3 ) qualitative assessments from patients and providers .


The trial was registered on January 27 , 2014 through the United States National Institutes of Health 's ClinicalTrials.gov NCT02047929 and funded by the Patient-Centered Outcomes Research Institute ( PCORI ) .


Adverse events ( AEs ) are health related events , reported by participants in clinical trials .


We describe AEs in the PACE trial of treatments for chronic fatigue syndrome ( CFS ) and baseline characteristics associated with them .


AEs were recorded on three occasions over one year in 641 participants .


We compared the numbers and nature of AEs between treatment arms of specialist medical care ( SMC ) alone , or SMC supplemented by adaptive pacing therapy ( APT ) , cognitive behaviour therapy ( CBT ) or graded exercise therapy ( GET ) .


We examined associations with baseline measures by binary logistic regression analyses , and compared the proportions of participants who deteriorated by clinically important amounts .


Serious adverse events and reactions were infrequent .


Non-serious adverse events were common ; the median ( quartiles ) number was 4 ( 2 , 8 ) per participant , with no significant differences between treatments ( P = .47 ) .


A greater number of NSAEs were associated with recruitment centre , and baseline physical symptom count , body mass index , and depressive disorder .


Physical function deteriorated in 39 ( 25 % ) participants after APT , 15 ( 9 % ) after CBT , 18 ( 11 % ) after GET , and 28 ( 18 % ) after SMC ( P < .001 ) , with no significant differences in worsening fatigue .


The numbers of adverse events did not differ significantly between trial treatments , but physical deterioration occurred most often after APT .


The reporting of non-serious adverse events may reflect the nature of the illness rather than the effect of treatments .


Differences between centres suggest that both standardisation of ascertainment methods and training are important when collecting adverse event data .


The principal objective of the present work was to examine the effects of mind state ( mind-wandering vs. on-task ) on driving performance in a high-fidelity driving simulator .


Mind-wandering is thought to interfere with goal-directed thought .


It is likely , then , that when driving , mind-wandering might lead to impairments in critical aspects of driving performance .


In two experiments , we assess the extent to which mind-wandering interferes with responsiveness to sudden events , mean velocity , and headway distance .


Using a car-following procedure in a high-fidelity driving simulator , participants were probed at random times to indicate whether they were on-task at that moment or mind-wandering .


The dependent measures were analyzed based on the participant 's response to the probe .


Compared to when on-task , when mind-wandering participants showed longer response times to sudden events , drove at a higher velocity , and maintained a shorter headway distance .


Collectively , these findings indicate that mind-wandering affects a broad range of driving responses and may therefore lead to higher crash risk .


The results suggest that situations that are likely associated with mind-wandering ( e.g. , route familiarity ) can impair driving performance .


No study has examined the effects of the combination of respiratory muscle training ( RMT ) and abdominal drawing-in maneuver ( ADIM ) on respiratory muscle activity and function in stroke patients during early pulmonary rehabilitation .


The purpose of this study was to investigate the effects of RMT combined with ADIM on decreased respiratory muscle activity and function in patients with post-stroke hemiplegia .


Thirty-seven subjects with post-stroke hemiplegia were randomly allocated to three groups ; integrated training group ( ITG ) , respiratory muscle training group ( RMTG ) , and control group ( CG ) .


All of the subjects received routine therapy for stroke rehabilitation for 1 hour , five times a week for 6 weeks .


Especially , the ITG received RMT using an incentive respiratory spirometer and ADIM using a Stabilizer , and the RMTG only received RMT using incentive respiratory spirometer for 15 minutes a day , five times a week for 6 weeks .


Pulmonary function was evaluated using spirometry for measuring the forced vital capacity ( FVC ) and force expiratory volume in 1 second ( FEV1 ) .


Additional surface electromyography ( sEMG ) analysis was included by measuring the respiratory muscle activity .


Our results showed that changes between the pre - and post-test values of FVC ( F = 12.50 , P = 0.02 ) and FEV1 ( F = 12.81 , P = 0.01 ) ( P < 0.05 ) in the ITG were significantly ( P < 0.05 ) greater .


Changes in EMG activation of the diaphragm ( F = 13.75 , P = 0.003 ) and external intercostal ( F = 14.33 , P = 0.002 ) ( P < 0.01 ) muscles of patients in the ITG during maximal static inspiratory efforts were significantly ( P < 0.05 ) greater than those in patients of the RMTG and the CG at post-test .


Our findings suggested that RMT combined with ADIM could improve pulmonary function in patients with post-stroke hemiplegia .


To study the effects of transcutaneous electrical nerve stimulation on multimodal analgesia after total knee arthroplasty .


Sixty patients diagnosed as knee osteoarthritis and suffered unilateral total knee arthroplasty in the department of orthopedics , Zhejiang Traditional Chinese Medicine Hospital from March 2009 to May 2012 were randomly divided into control group and test group , 30 cases in each group .


All the patients received celecoxib preoperatively , knee periarticular injection with the drug mixture intraoperatively , and celecoxib and morphine sulfate controlled-release tablets postoperatively .


The patients in the test group were also treated with transcutaneous electrical nerve stimulation each day after operation .


All the patients started doing functional exercises at 24 h after operation .


Postoperative visual analogue scales ( VAS ) , passive and active range of motion of knee joint , and complications were recorded .


The VAS scores of test group during postoperative 24 h to 1 week were 3.39 + / - 0.69 , 2.79 + / - 0.51 , 2.16 + / - 0.52 , and 1.07 + / - 0.57 separately , which were lower than 3.80 + / - 0.86 , 3.22 + / - 0.58 , 2.53 + / - 0.54 and 1.38 + / - 0.52 in the control group .


The passive and active range of knee joint motion in the test group during postoperative 24 h to 2 weeks were ( 30.67 + / - 3.65 ) degrees , ( 39.17 + / - 3.96 ) degrees , ( 47.83 + / - 4.86 ) degrees , ( 93.67 + / - 7.30 ) degrees , ( 107.67 + / - 7.51 ) degrees and ( 29.83 + / - 5.33 ) degrees , ( 78.33 + / - 8.24 ) degrees , ( 95.17 + / - 5.94 ) degrees respectively , which were higher than ( 28.67 + / - 3.92 ) degrees , ( 36.83 + / - 4.25 ) degrees , ( 45.17 + / - 5.17 ) degrees , ( 89.83 + / - 7.25 ) degrees , ( 103.17 + / - 7.37 ) degrees and ( 24.17 + / - 10.26 ) degrees , ( 73.83 + / - 9.07 ) degrees , ( 91.33 + / - 7.42 ) degrees in the control group .


In the test group , 19 patients had ring-shaped haemostasis impression to some extent in the skin of knee joint to different degree , and 5 patients had blister formation .


It is meaningful to apply transcutaneous electrical nerve stimulation for treating multimodal analgesia after total knee arthroplasty , which can not only relieve patients ' postoperative pain , and also promote the rehabilitation of knee function as far as possible .


Current efforts to improve clinical effectiveness and utility of repetitive transcranial magnetic stimulation ( rTMS ) in the treatment of major depression ( MD ) include theta burst stimulation ( TBS ) , a patterned form of rTMS .


Here , we investigated the efficacy of bilateral TBS to the dorsolateral prefrontal cortex ( dlPFC ) in patients with MD in additon to ongoing medication and psychotherapy .


In this randomized-controlled trial , thirty-two patients with MD were treated for six weeks ( thirty sessions ) with either successively intermittent , activity enhancing TBS ( iTBS ) to the left and continuous , inhibiting TBS ( cTBS ) to the right dlPFC or with bilateral sham stimulation .


Primary outcome measure was the proportion of treatment response defined as a Montgomery-sberg Depression Rating Scale ( MADRS ) 50 % compared to baseline .


Secondary outcomes comprised response and remission rates of the Hamilton Depression Rating Scale ( HAMD ) and the Beck Depression Inventory ( BDI ) .


A larger number of responders were found in the cTBS ( n = 9 ) compared to the sham-stimulation ( n = 4 ) group ( odds ratio : 3.86 ; Wald ( 2 ) = 3.9 , p = 0.048 ) .


On secondary endpoint analysis , patient-reported outcome as assessed by the BDI , pointed towards a higher rate of remitters in the cTBS ( n = 6 ) than in the sham ( n = 1 ) group ( odds ratio : 9 ; Wald ( 2 ) = 3.5 , p = 0.061 ) .


With regard to the pilot character of the study and the small sample size , the results have to be considered as preliminary .


These findings provide first evidence that six weeks treatment of MDD with iTBS to the left and cTBS to the right dlPFC for six weeks is safe , feasible and superior to sham stimulation applied add-on to pharmacological and psychotherapeutic treatment .


The time of lung cancer screening may provide the ideal setting to discuss and initiate a smoking cessation plan that includes pharmacologic aids .


No studies to date have fully investigated the potential effectiveness of such combined approach .


We prospectively evaluated the biochemically verified 1-year continuous abstinence rate from smoking of 187 persistent smokers enrolled within the Multicentric Italian Lung Detection Trial ( MILD ) , who received a pharmacologic aid to quit smoking with varenicline along with behavioral counseling .


The propensity of study subjects to succeed in smoking cessation was also monitored .


At 12 months , the continuous abstinence rate from smoking was achieved in 37 out of 187 patients ( 19.8 % ) , with a propensity to succeed in smoking cessation for the assisted attempt equal to 1.43 , as compared to an unassisted MILD patient .


At the end of the third month of therapy , 48.7 % of subjects showed a continuous abstinence rate , while only 33.7 % of patients were abstinent from smoking at 6 months .


At baseline , the subgroup of MILD participants who were originally allocated to lung tomography showed higher smoking intensity than those allocated to no screening .


A combined smoking cessation intervention can be implemented with satisfactory results within a lung cancer screening program ; this preliminary observation needs to be replicated in a prospective investigation .


Clinicians should consider that lung cancer screening may be falsely reassuring for persistent smokers ; therefore it should always be coupled with a smoking cessation program .


To evaluate the new RetroView colonoscope and compare its ability to detect simulated polyps `` hidden '' behind colonic folds with that of a conventional colonoscope , utilizing anatomic colon models .


Three anatomic colon models were prepared , with twelve simulated polyps `` hidden '' behind haustral folds and five placed in easily viewed locations in each model .


Five blinded endoscopists examined two colon models in random order with the conventional or RetroView colonoscope , utilizing standard withdrawal technique .


The third colon model was then examined with the RetroView colonoscope withdrawn initially in retroflexion and then in standard withdrawal .


Polyp detection rates during standard and retroflexed withdrawal of the conventional and RetroView colonoscopes were determined .


Polyp detection rates for combined standard and retroflexed withdrawal ( combination withdrawal ) with the RetroView colonoscope were also determined .


For hidden polyps , retroflexed withdrawal using the RetroView colonoscope detected more polyps than the conventional colonoscope in standard withdrawal ( 85 % vs 12 % , P = 0.0001 ) .


For hidden polyps , combination withdrawal with the RetroView colonoscope detected more polyps than the conventional colonoscope in standard withdrawal ( 93 % vs 12 % , P 0.0001 ) .


The RetroView colonoscope in `` combination withdrawal '' was superior to other methods in detecting all ( hidden + easily visible ) polyps , with successful detection of 80 of 85 polyps ( 94 % ) compared to 28 ( 32 % ) polyps detected by the conventional colonoscope in standard withdrawal ( P < 0.0001 ) and 67 ( 79 % ) polyps detected by the RetroView colonoscope in retroflexed withdrawal alone ( P < 0.01 ) .


Continuous withdrawal of the colonoscope through the colon model while retroflexed was achieved by all endoscopists .


In a post-test survey , four out of five colonoscopists reported that manipulation of the colonoscope was easy or very easy .


In simulated testing , the RetroView colonoscope increased detection of hidden polyps .


Combining standard withdrawal with retroflexed withdrawal may become the new paradigm for `` complete screening colonoscopy '' .


Parents of children and adolescents with diabetes type 1 ( DT1 ) usually experience high stress levels , as they have to cope with multiple demands in their everyday life .


Different complex interventions have been implemented , which sometimes have led to opposite results .


The purpose of this study was to assess stress levels in parents of children and adolescents with DT1 and to evaluate the effectiveness of a stress management program ( progressive muscle relaxation combined with diaphragmatic breathing ) in reducing perceived and parenting stress , increasing internal locus of control , promoting healthy lifestyle , and normalizing cortisol levels .


Randomized controlled trial .


A total of 44 parents were randomly assigned to the intervention group ( performing relaxation for eight weeks , n = 19 ) and control group ( n = 25 ) .


Pre-post measurements included cortisol levels , lifestyle characteristics , perceived stress , perception of health , and parenting stress .


A statistically significant decrease in perceived stress ( from 27.21 to 19.00 , P = .001 ) , as well as in parenting stress ( from 85.79 to 73.68 , P = .003 ) , was observed in the intervention group .


A statistically significant difference was found in perceived stress between the two groups after the intervention ( Dmean = 6.64 , P = .010 ) .


No significant difference was revealed between or within the groups in cortisol levels .


Significant improvement was reported by the subjects of the intervention group in various lifestyle parameters .


Relaxation techniques seem to have a positive impact on stress and on various lifestyle factors in parents of children and adolescents with DT1 .


Future research on long-term benefits of an intervention program comprising of various relaxation schemes is warranted .


Consumption of a cholesterol lowering dietary portfolio including plant sterols ( PS ) , viscous fibre , soy proteins and nuts for 6 months improves blood lipid profile .


Plant sterols reduce blood cholesterol by inhibiting intestinal cholesterol absorption and concerns have been raised whether PS consumption reduces fat soluble vitamin absorption .


The objective was to determine effects of consumption of a cholesterol lowering dietary portfolio on circulating concentrations of PS and fat soluble vitamins .


Using a parallel design study , 351 hyperlipidemic participants from 4 centres across Canada were randomized to 1 of 3 groups .


Participants followed dietary advice with control or portfolio diet .


Participants on routine and intensive portfolio involved 2 and 7 clinic visits , respectively , over 6 months .


No changes in plasma concentrations of and tocopherol , lutein , lycopene and retinol , but decreased - carotene concentrations were observed with intensive ( week 12 : p = 0.045 ; week 24 : p = 0.039 ) and routine ( week 12 : p = 0.031 ; week 24 : p = 0.078 ) portfolio groups compared to control .


However , cholesterol adjusted - carotene and fat soluble compound concentrations were not different compared to control .


Plasma PS concentrations were increased with intensive ( campesterol :p = 0.012 ; - sitosterol :p = 0.035 ) and routine ( campesterol : p = 0.034 ; - sitosterol : p = 0.080 ) portfolio groups compared to control .


Plasma cholesterol-adjusted campesterol and - sitosterol concentrations were negatively correlated ( p < 0.001 ) with total and LDL-C levels .


Results demonstrate that consuming a portfolio diet reduces serum total and LDL-C levels while increasing PS values , without altering fat soluble compounds concentrations .


The extent of increments of PS with the current study are not deleterious and also maintaining optimum levels of fat soluble vitamins are of paramount necessity to maintain overall metabolism and health .


Results indicate portfolio diet as one of the best options for CVD risk reduction .


clinicaltrials.gov Identifier : NCT00438425 .


To better understand the role of the professional oral health care for elderly in improving geriatric oral health , the effects of short-term professional oral health care ( once per week for 1 month ) on oral microbiological parameters were assessed .


Parallel , open-labelled , randomize-controlled trial was undertaken in a nursing home for elderly in Shizuoka , Japan .


Thirty-four dentate elderly over 74 years were randomly assigned from ID number to the intervention ( 17/34 ) and control ( 17/34 ) groups .


The outcomes were changes in oral microbiological parameters ( number of bacteria in unstimulated saliva ; whole bacteria , Streptococcus , Fusobacterium and Prevotella : opportunistic pathogens detection : and index of oral hygiene evaluation [ Dental Plaque Index , DPI ] ) within the intervention period .


Each parameter was evaluated at before and after intervention period .


Four elderly were lost from mortality ( 1 ) , bone fracture ( 1 ) , refused to participate ( 1 ) and multi-antibiotics usage ( 1 ) .


Finally , 30 elderly were analysed ( 14/intervention and 16/control ) .


At baseline , no difference was found between the control and intervention groups .


After the intervention period , the percentage of Streptococcus species increased significantly in the intervention group ( Intervention , 86 % [ 12/14 ] ; Control , 50 % [ 8/16 ] : Fisher 's , right-tailed , P < 0.05 ) .


Moreover , DPI significantly improved in the intervention group ( Intervention , 57 % [ 8/14 ] ; Control , 13 % [ 2/16 ] : Fisher 's , two-tailed , P < 0.05 ) .


The improvement in DPI extended for 3 months after intervention .


None of side effects were reported .


The short-term professional oral health care can improve oral conditions in the elderly .


Physical activity guidelines recommend engaging in moderate - and vigorous-intensity physical activity to elicit health benefits .


Similarly , these higher intensity ranges for activity are typically targeted in healthy living interventions ( ie , exercise prescription ) .


Comparatively less attention has been focused on changing lower intensity physical activity ( ie , sedentary activity ) behaviors .


The purpose of this study was to explore the effects of prescribing changes to physical activity of various intensities ( ie , sedentary through exercise ) through the primary care setting .


Sixty older adults ( aged 55-75 years ; mean age 63 = 5 years ) volunteered to participate , and were randomly assigned to 4 groups : 3 receiving an activity prescription intervention targeting a specific intensity of physical activity ( exercise , sedentary , or both ) , and 1 control group .


During the 12-week intervention period participants followed personalized activity programs at home .


Basic clinical measures ( anthropometrics , blood pressure , aerobic fitness ) and blood panel for assessing cardiometabolic risk ( glucose , lipid profile ) were conducted at baseline ( week 0 ) and follow-up ( week 12 ) in a primary care office .


There were no differences between groups at baseline ( P > 0.05 ) .


The intervention changed clinical ( F , = 20.458 , P = 0.000 , P = 0.672 ) and blood panel measures ( F , = 4.576 , P = 0.002 , P = 0.314 ) of cardiometabolic health .


Post hoc analyses indicted no differences between groups ( P > 0.05 ) .


Physical activity prescription of various intensities through the primary care setting improved cardiometabolic health status .


To our knowledge , this is the first report of sedentary behavior prescription ( alone , or combined with exercise ) in primary care .


The findings support the ongoing practice of fitness assessment and physical activity prescription for chronic disease management and prevention .


`` Practice effects '' ( PE ) , or performance improvements due to prior exposure to testing , are known to confound cognitive test results , particularly when short intervals occur between two test sessions .


We examined two subsamples with short or long re-test intervals from a recent clinical trial .


Thirty-four non-depressed adults with mild Huntington Disease ( HD ) participated .


Three cognitive tests were administered at screening and again at baseline , before active treatment randomization .


Half the sample had a 24-hour retest interval while the other half was > 6-days .


The two groups differed on demographic/clinical factors ( age , Total Motor Score and Total Functional Capacity ) .


After controlling for age and motor score , PE differences were found on three of the five UHDRS cognitive tests : the longer interval group showed larger PE on Symbol-Digit Modalities and Stroop color , while the rapid interval group had larger PE on Stroop interference .


Controlling for screening cognitive performance yielded similar results .


Length of interval between screening and baseline visits and level of disease severity may influence stability of UHDRS cognitive test results in clinical trials in HD .


There is increasing evidence that vaccines have an effect on general mortality which goes beyond specific disease protection .


Oral polio vaccine ( OPV ) is widely used in low-income countries , but in observational studies in Guinea-Bissau we observed that not receiving OPV at birth was associated with reduced overall male infant mortality and enhanced immune response to BCG vaccine .


We therefore initiated a randomized trial to test the overall effect of OPV at birth ( OPV0 ) .


A small thymic gland is a predictor of mortality in high-mortality settings .


Within the trial we aimed to test whether no-OPV0 was associated with increased thymic size .


In 511 normal birth weight infants who were randomized to receive or not receive OPV0 , thymic index and thymus/weight index were measured before randomization and after 2 weeks ( N = 49 ) , 4 weeks ( N = 308 ) or 6 weeks ( N = 27 ) .


The association between OPV0 and the log transformed thymic size indicators were analyzed in ANCOVA models with thymic size at follow-up as the outcome and adjusting for thymic size at enrollment and age at follow-up .


Estimates were reported as geometric mean ratios ( GMR ) with 95 % confidence intervals , comparing no-OPV0 to OPV0 .


No-OPV0 was not associated with thymic index after 2 weeks ( GMR : 1.14 ( 0.99-1 .30 ) ) , after 4 weeks ( GMR : 0.98 ( 0.93-1 .05 ) ) or after 6 weeks ( GMR : 1.00 ( 0.81-1 .23 ) ) .


However , no-OPV0 was associated with increased thymus/weight index after 2 weeks ( GMR : 1.22 ( 1.06-1 .40 ) ) , but the effect was not seen after 4 weeks ( GMR : 0.97 ( 0.92-1 .03 ) ) and 6 weeks ( GMR : 0.99 ( 0.82-1 .19 ) ) .


There were no strong sex-differences .


Overall there was no effect on thymic size of OPV0 when administered with BCG .


The results could indicate that if an effect occurs , it is only within the first weeks after vaccination .


This study investigated the influence of injury cause , contact-sport participation , and prior knowledge of mild traumatic brain injury ( mTBI ) on injury beliefs and chronic symptom expectations of mTBI .


A total of 185 non-contact-sport players ( non-CSPs ) and 59 contact-sport players ( CSPs ) with no history of mTBI were randomly allocated to one of two conditions in which they read either a vignette depicting a sport-related mTBI ( mTBIsport ) or a motor-vehicle-accident-related mTBI ( mTBIMVA ) .


The vignettes were otherwise standardized to convey the same injury parameters ( e.g. , duration of loss of consciousness ) .


After reading a vignette , participants reported their injury beliefs ( i.e. , perceptions of injury undesirability , chronicity , and consequences ) and their expectations of chronic postconcussion syndrome ( PCS ) and posttraumatic stress disorder ( PTSD ) symptoms .


Non-CSPs held significantly more negative beliefs and expected greater PTSD symptomatology and greater PCS affective symptomatology from an mTBIMVA vignette thann mTBIsport vignette , but this difference was not found for CSPs .


Unlike CSPs , non-CSPs who personally knew someone who had sustained an mTBI expected significantly less PCS symptomatology than those who did not .


Despite these different results for non-CSPs and CSPs , overall , contact-sport participation did not significantly affect injury beliefs and symptom expectations from an mTBIsport .


Expectations of persistent problems after an mTBI are influenced by factors such as injury cause even when injury parameters are held constant .


Personal knowledge of mTBI , but not contact sport participation , may account for some variability in mTBI beliefs and expectations .


These factors require consideration when assessing mTBI outcome .


Previous research has demonstrated that current methods of informed consent are relatively ineffective as shown by poor recall and comprehension by adolescent patients and their parents .


The purpose of this study was to determine whether adding a short videotape presentation reiterating the issues related to informed consent to a modified informed consent document that emphasizes a limited number of core and patient-specific custom `` chunks '' at the beginning of an informed consent presentation improved the recall and comprehension of the risks , benefits , and alternatives of orthodontic treatment .


A second objective was to evaluate the current related data for recommendable practices .


Seventy patient-parent pairs were randomly divided into 2 groups .


The intervention group ( group A ) patients and parents together reviewed a customized slide show and a short videotape presentation describing the key risks of orthodontic treatment .


Group B followed the same protocol without viewing the videotape .


All patients and parents were interviewed independently by research assistants using an established measurement tool with open-ended questions .


Interviews were transcribed and scored for the appropriateness of responses using a previously established codebook .


Lastly , the patients and parents were given 2 reading literacy tests , 1 related to health and 1 with general content followed by the self-administered demographic and psychological state questionnaires .


There were no significant differences between the groups for sociodemographic variables .


There were no significant differences between the groups for overall recall and comprehension ; recall and comprehension for the domains of treatment , risk , and responsibility ; and recall and comprehension for core , general , and custom items .


The positional effects were limited in impact .


When compared with previous studies , these data further demonstrate the benefit of improved readability and audiovisual supplementation with the addition of `` chunking . ''


There is no benefit to adding a short video to the previously established improved readability and audiovisual supplementation .


There is a significant benefit of improved readability and audiovisual slide supplementation with the addition of `` chunking '' over traditional informed consent methods in terms of patient improvement in overall comprehension , treatment recall , and treatment comprehension .


The treatment domain is the most affected .


War-related trauma , posttraumatic stress disorder ( PTSD ) , depression and suicide are common in US military members .


Often , those affected do not seek treatment due to stigma and barriers to care .


When care is sought , it often fails to meet quality standards .


A randomized trial is assessing whether collaborative primary care improves quality and outcomes of PTSD and depression care in the US military health system .


The aim of this study is to describe the design and sample for a randomized effectiveness trial of collaborative care for PTSD and depression in military members attending primary care .


The STEPS-UP Trial ( STepped Enhancement of PTSD Services Using Primary Care ) is a 6 installation ( 18 clinic ) randomized effectiveness trial in the US military health system .


Study rationale , design , enrollment and sample characteristics are summarized .


Military members attending primary care with suspected PTSD , depression or both were referred to care management and recruited for the trial ( 2592 ) , and 1041 gave permission to contact for research participation .


Of those , 666 ( 64 % ) met eligibility criteria , completed baseline assessments , and were randomized to 12 months of usual collaborative primary care versus STEPS-UP collaborative care .


Implementation was locally managed for usual collaborative care and centrally managed for STEPS-UP .


Research reassessments occurred at 3 - , 6 - , and 12-months .


Baseline characteristics were similar across the two intervention groups .


STEPS-UP will be the first large scale randomized effectiveness trial completed in the US military health system , assessing how an implementation model affects collaborative care impact on mental health outcomes .


It promises lessons for health system change .


Survival is poorer in elderly patients with head and neck squamous cell carcinomas [ HNSCCs ] than in younger patients .


Possible explanations include a contribution of co-morbidities to mortality , frequent refusal of standard therapy , and the use of suboptimal treatments due to concern about toxicities .


The Comprehensive Geriatric Assessment [ CGA ] is a multidimensional assessment of general health that can help to customise treatment and follow-up plans .


The CGA has been proven effective in several health settings but has not been evaluated in randomised studies of patients with cancer .


Our aim here was to assess the impact of the CGA on overall survival , function , and nutritional status of elderly patients with HNSCC .


EGeSOR is an open-label , multicentre , randomised , controlled , parallel-group trial in patients aged 70 years or older and receiving standard care for HNSCC .


The intervention includes four components : the CGA conducted by a geriatrician before cancer treatment , participation of the same geriatrician in cancer treatment selection , a standardised geriatric therapeutic intervention designed by the same geriatrician ; and geriatric follow-up for 24 months .


The primary endpoint , assessed after 6 months , is a composite criterion including death , functional impairment [ Activities of Daily Living score decrease 2 ] , and weight loss 10 % .


Secondary endpoints include progression-free survival , unscheduled admissions , quality of life , treatment toxicities , costs , and completion of the planned cancer treatment .


A centralised online system is used to perform 1:1 randomisation with a minimisation algorithm for centre , age , T and N stages , and tumour site [ oral , oropharyngeal , hypopharyngeal , or laryngeal ] .


The estimated sample size is 704 patients , who are being recruited by 14 centres in 9 French cities .


EGeSOR is the first randomised trial of the CGA in elderly cancer patients .


We expect the CGA to have direct clinical benefits on the management of elderly patients with HNSCC .


If this expectation is fulfilled , the trial may lead to modifications of the management model for elderly patients with cancer .


Trial registration : NCT02025062 .


Laparoscopic ventral hernia repair ( LVHR ) is associated with considerable postoperative pain .


Transversus abdominis plane ( TAP ) blocks have proven effective in controlling postoperative pain in a variety of laparoscopic abdominal operations .


To date , no studies have focused on TAP blocks in LVHR .


Our goal was to assess whether TAP blocks reduce opioid requirements and pain scores after LVHR .


Patients undergoing LVHR were randomly assigned to receive a TAP block or placebo injection .


The primary end points were cumulative opioid use at 1 , 3 , 6 , 12 , 18 , and 24 hours postoperatively and pain scores recorded at 1 and 24 hours postoperatively .


Patients in the experimental TAP group ( n = 52 ) and control group ( n = 48 ) were comparable with respect to patient demographics and clinical characteristics .


In the postanesthesia care unit , the TAP group had significantly lower pain scores than the control group ( p < 0.05 ) .


Patients in the TAP group used less opioids than the control group at each time point assessed after 6 hours postoperatively ( p < 0.05 ) .


There was no significant difference in pain scores at 24 hours postoperatively ( p > 0.05 ) .


Transversus abdominis plane blocks given during LVHR significantly decrease both short-term postoperative opioid use and pain experienced by patients .


Research conducted with adults suggests that successful weight losers demonstrate greater activation in brain regions associated with executive control in response to viewing high-energy foods .


No previous studies have examined these associations in adolescents .


Functional neuroimaging was used to assess brain response to food images among groups of overweight ( OW ) , normal-weight ( NW ) , and successful weight-losing ( SWL ) adolescents .


Eleven SWL , 12 NW , and 11 OW participants underwent functional magnetic resonance imaging while viewing images of high - and low-energy foods .


When viewing high-energy food images , SWLs demonstrated greater activation in the dorsolateral prefrontal cortex ( DLPFC ) compared with OW and NW controls .


Compared with NW and SWL groups , OW individuals demonstrated greater activation in the ventral striatum and anterior cingulate in response to food images .


Adolescent SWLs demonstrated greater neural activation in the DLPFC compared with OW/NW controls when viewing high-energy food stimuli , which may indicate enhanced executive control .


OW individuals ' brain responses to food stimuli may indicate greater reward incentive processes than either SWL or NW groups .


The integration of simulation into the training of health care professionals provides context for decision making and procedural skills in a high-fidelity environment , without risk to actual patients .


It was hypothesised that a novel approach to simulation-based education - error management training - would produce higher performance ratings compared with traditional step-by-step instruction .


Radiology technology students were randomly assigned to participate in traditional procedural-based instruction ( n = 11 ) or vicarious error management training ( n = 11 ) .


All watched an instructional video and discussed how well each incident was handled ( traditional instruction group ) or identified where the errors were made ( vicarious error management training ) .


Students then participated in a 30-minute case-based simulation .


Simulations were videotaped for performance analysis .


Blinded experts evaluated performance using a predefined evaluation tool created specifically for the scenario .


Blinded experts evaluated performance using a predefined evaluation toolcreated specifically for the scenario


The vicarious error management group scored higher on observer-rated performance ( Mean = 9.49 ) than students in the traditional instruction group ( Mean = 9.02 ; p < 0.01 ) .


These findings suggest that incorporating the discussion of errors and how to handle errors during the learning session will better equip students when performing hands-on procedures and skills .


This pilot study provides preliminary evidence for integrating error management skills into medical curricula and for the design of learning goals in simulation-based education .


Dry eye is a multifactorial disease of the tears and the ocular surface .


This study aimed to investigate the clinical efficacy of a non-steroidal anti-inflammatory drug , pranoprofen , in the treatment of dry eye .


It is a prospective , multi-center , randomized , controlled , parallel group study .


One hundred and fifteen patients with mild to moderate dry eye disease ( 55-60 in each treatment group ) participated in this multi-center study .


Patients were randomly administered with eyedrops containing 0.1 % pranoprofen ( PRA ) plus 0.1 % sodium hyaluronate ( SH ) or SH only , three times daily for 28 days , followed by a 1-week after treatment observation .


Dry eye symptom score ( DESS ) , fluorescein corneal staining ( FLCS ) , tear break-up time ( TBUT ) , and Shirmer 1 tear test ( ST1 , without anesthesia ) were evaluated or conducted before treatment and at each study visit .


Conjunctival impression cytology was taken from the patients treated with PRA plus SH before and after treatment and real-time polymerase chain reaction ( RT-PCR ) was performed to detect the changes of human leukocyte antigen DR ( HLA-DR ) and intercellular adhesion molecule 1 ( ICAM-1 ) .


Patients treated with PRA plus SH showed gradual improvements of DESS , FLCS , and TBUT .


Between-group comparisons of FLCS and TBUT have statistically significant differences from day 14 .


Good tolerance with no severe adverse events was found in both groups .


Patients treated with PRA plus SH had a reduced expression level of HLA-DR and were statistically different after 28 days of therapy .


The application of PRA at a dose of 0.1 % was well tolerated and benefited to the patients with mild to moderate dry eye disease .


The underlying mechanism of its efficacy may be associated with the reduction of inflammatory factors of conjunctival epithelial cells .


We investigated the pattern of rash , diarrhea , and hepatic adverse events ( AEs ) secondary to lapatinib and their association with age and pathologic complete response ( pCR ) in the Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation ( NeoALLTO ) phase III trial .


Patients with HER2-positive early breast cancer were randomly assigned to receive lapatinib ( Arm A ) , trastuzumab ( Arm B ) , or their combination ( Arm C ) for 6 weeks followed by the addition of paclitaxel for 12 weeks before surgery .


We investigated the frequency and time to developing each AE according to age ( 50 v > 50 years ) and their association with pCR in a logistic regression model adjusted for age , hormone receptors , tumor size , nodal status , planned breast surgery , completion of lapatinib administration , and treatment arm .


Only patients randomly assigned to arms A and C were eligible ( n = 306 ) .


Younger patients ( 50 years ) experienced significantly more rash compared with older patients ( 74.4 % v 47.9 % ; P < .0001 ) .


Diarrhea and hepatic AEs were observed in 78.8 % and 41.2 % of patients , respectively , with no differences in rate or severity or time of onset according to age .


Early rash ( ie , before starting paclitaxel ) was independently associated with a higher chance of pCR , mainly in patients older than 50 years ( odds ratio [ OR ] = 3.76 ; 95 % CI , 1.69 to 8.34 ) but not in those 50 years ( OR = 0.92 ; 95 % CI , 0.45 to 1.88 ; P for interaction = .01 ) .


No significant association was observed between pCR and diarrhea or hepatic AEs .


Our results indicate that the frequency and clinical relevance of lapatinib-related rash is largely dependent on patient age .


We examined whether the effects of topiramate and a single nucleotide polymorphism ( rs2832407 ) in GRIK1 , which encodes a kainate receptor subunit , persisted following a 12-week , placebo-controlled trial in 138 heavy drinkers with a treatment goal of reduced drinking .


During treatment , topiramate 200mg/d significantly reduced heavy drinking days and increased the frequency of abstinent days ( Am J Psychiatry , 2014 , 171:445 ) .


In the European-American ( EA ) subsample ( n = 122 ) , rs2832407 moderated the treatment effect on heavy drinking .


Patients were re-interviewed 3 and 6months after the end of treatment .


During treatment , we obtained 92.4 % of drinking data , with 89.1 and 85.5 % complete data at the 3 - and 6-month follow-up visits , respectively .


We examined 4 outcomes over time in the overall sample and the EA subsample : percent heavy drinking days ( PHDD ) , percent days abstinent ( PDA ) , serum - glutamyl transpeptidase ( GGTP ) concentration , and a measure of alcohol-related problems .


In the full sample , the lower PHDD and higher PDA seen with topiramate treatment were no longer significant during follow-up .


Nonetheless , the topiramate-treated patients had lower alcohol-related problem scores during treatment and both follow-up periods .


Further , in the EA subsample , the greater reduction in PHDD seen with topiramate treatment in rs2832407 * C-allele homozygotes persisted throughout follow-up , with no significant effects in A-allele carriers .


A reduction in GGTP concentration was consistent with the reduction in heavy drinking , but did not reach statistical significance .


There are persistent therapeutic effects of topiramate in heavy drinkers , principally in rs2832407 * C-allele homozygotes .


We introduce a new method of peritoneal dialysis ( PD ) catheter placement with cystoscopic assistance .


It has clear advantages compared with conventional open surgery .


Patients with end-stage renal disease ( ESRD ) were randomly divided into two groups .


Group A ( 14 patients ) underwent cystoscopy-assisted surgery , and group B ( 15 patients ) underwent conventional open surgery for the PD catheter placement .


Continuous ambulatory PD training was started 14 days after surgery in both groups .


We evaluated the differences between the two groups prospectively .


Both groups had no difference in demographics including age , male/female ratio , previous abdominal surgery percent , and cause of ESRD ( p > 0.05 ) .


All catheters were placed successfully without mortality .


Group A had better surgery-related data : local anesthesia rate , VAS ( Visual Analogue Score ) , incisional length , and hospital stay were significantly different compared with group B ( p < 0.05 ) .


And the blood loss duration surgery and duration of surgery were not significantly different ( p > 0.05 ) .


In group A , there was no case of catheter obstruction and migration , dialysate leak , exit site infection , or incisional hernia .


There was only one peritonitis case in group A. Compared with group B , the total surgical complications difference was significant ( p < 0.05 ) .


Cystoscopy-assisted PD catheter placement is a direct , visual , safe , precise , easy , inexpensive , and minimally invasive technique that is ideal for patients with ESRD .


The optimum duration of first-line treatment with chemotherapy in combination with bevacizumab in patients with metastatic colorectal cancer is unknown .


The CAIRO3 study was designed to determine the efficacy of maintenance treatment with capecitabine plus bevacizumab versus observation .


In this open-label , phase 3 , randomised controlled trial , we recruited patients in 64 hospitals in the Netherlands .


We included patients older than 18 years with previously untreated metastatic colorectal cancer , with stable disease or better after induction treatment with six 3-weekly cycles of capecitabine , oxaliplatin , and bevacizumab ( CAPOX-B ) , WHO performance status of 0 or 1 , and adequate bone marrow , liver , and renal function .


Patients were randomly assigned ( 1:1 ) to either maintenance treatment with capecitabine and bevacizumab ( maintenance group ) or observation ( observation group ) .


Randomisation was done centrally by minimisation , with stratification according to previous adjuvant chemotherapy , response to induction treatment , WHO performance status , serum lactate dehydrogenase concentration , and treatment centre .


Both patients and investigators were aware of treatment assignment .


We assessed disease status every 9 weeks .


On first progression ( defined as PFS1 ) , patients in both groups were to receive the induction regimen of CAPOX-B until second progression ( PFS2 ) , which was the study 's primary endpoint .


All endpoints were calculated from the time of randomisation .


Analyses were done by intention to treat .


This trial is registered with ClinicalTrials.gov , number NCT00442637 .


Between May 30 , 2007 , and Oct 15 , 2012 , we randomly assigned 558 patients to either the maintenance group ( n = 279 ) or the observation group ( n = 279 ) .


Median follow-up was 48 months ( IQR 36-57 ) .


The primary endpoint of median PFS2 was significantly improved in patients on maintenance treatment , and was 85 months in the observation group and 117 months in the maintenance group ( HR 067 , 95 % CI 056-081 , p < 00001 ) .


This difference remained significant when any treatment after PFS1 was considered .


Maintenance treatment was well tolerated , although the incidence of hand-foot syndrome was increased ( 64 [ 23 % ] patients with hand-foot skin reaction during maintenance ) .


The global quality of life did not deteriorate during maintenance treatment and was clinically not different between treatment groups .


Maintenance treatment with capecitabine plus bevacizumab after six cycles of CAPOX-B in patients with metastatic colorectal cancer is effective and does not compromise quality of life .


Dutch Colorectal Cancer Group ( DCCG ) .


The DCCG received financial support for the study from the Commissie Klinische Studies ( CKS ) of the Dutch Cancer Foundation ( KWF ) , Roche , and Sanofi-Aventis .


Self-guided , Web-based interventions for depression show promising results but suffer from high attrition and low user engagement .


Online peer support networks can be highly engaging , but they show mixed results and lack evidence-based content .


Our aim was to introduce and evaluate a novel Web-based , peer-to-peer cognitive reappraisal platform designed to promote evidence-based techniques , with the hypotheses that ( 1 ) repeated use of the platform increases reappraisal and reduces depression and ( 2 ) that the social , crowdsourced interactions enhance engagement .


Participants aged 18-35 were recruited online and were randomly assigned to the treatment group , `` Panoply '' ( n = 84 ) , or an active control group , online expressive writing ( n = 82 ) .


Both are fully automated Web-based platforms .


Participants were asked to use their assigned platform for a minimum of 25 minutes per week for 3 weeks .


Both platforms involved posting descriptions of stressful thoughts and situations .


Participants on the Panoply platform additionally received crowdsourced reappraisal support immediately after submitting a post ( median response time = 9 minutes ) .


Panoply participants could also practice reappraising stressful situations submitted by other users .


Online questionnaires administered at baseline and 3 weeks assessed depression symptoms , reappraisal , and perseverative thinking .


Engagement was assessed through self-report measures , session data , and activity levels .


The Panoply platform produced significant improvements from pre to post for depression ( P = .001 ) , reappraisal ( P < .001 ) , and perseverative thinking ( P < .001 ) .


The expressive writing platform yielded significant pre to post improvements for depression ( P = .02 ) and perseverative thinking ( P < .001 ) , but not reappraisal ( P = .45 ) .


The two groups did not diverge significantly at post-test on measures of depression or perseverative thinking , though Panoply users had significantly higher reappraisal scores ( P = .02 ) than expressive writing .


We also found significant group by treatment interactions .


Individuals with elevated depression symptoms showed greater comparative benefit from Panoply for depression ( P = .02 ) and perseverative thinking ( P = .008 ) .


Individuals with baseline reappraisal deficits showed greater comparative benefit from Panoply for depression ( P = .002 ) and perseverative thinking ( P = .002 ) .


Changes in reappraisal mediated the effects of Panoply , but not the expressive writing platform , for both outcomes of depression ( ab = -1.04 , SE 0.58 , 95 % CI -2.67 to -.12 ) and perseverative thinking ( ab = -1.02 , SE 0.61 , 95 % CI -2.88 to -.20 ) .


Dropout rates were similar for the two platforms ; however , Panoply yielded significantly more usage activity ( P < .001 ) and significantly greater user experience scores ( P < .001 ) .


Panoply engaged its users and was especially helpful for depressed individuals and for those who might ordinarily underutilize reappraisal techniques .


Further investigation is needed to examine the long-term effects of such a platform and whether the benefits generalize to a more diverse population of users .


ClinicalTrials.gov NCT02302248 ; https://clinicaltrials.gov/ct2/show/NCT02302248 ( Archived by WebCite at http://www.webcitation.org/6Wtkj6CXU ) .


To improve patient health , recent research urges for medical decision aids that are designed to enhance the effectiveness of specific medically related decisions .


Many such decisions involve complex information , and decision aids that independently use deliberative ( analytical and slower ) or intuitive ( more affective and automatic ) cognitive processes for such decisions result in suboptimal decisions .


Unconscious thought can arguably use both intuitive and deliberative ( slow and analytic ) processes , and this combination may further benefit complex patient ( or practitioner ) decisions as medical decision aids .


Indeed , mounting research demonstrates that individuals render better decisions generally if they are distracted from thinking consciously about complex information after it is presented ( but can think unconsciously ) , relative to thinking about that information consciously or not at all .


The current research tested whether the benefits of unconscious thought processes can be replicated using an Internet platform for a patient medical decision involving complex information .


This research also explored the possibility that judgments reported after a period of unconscious thought are actually the result of a short period of conscious deliberation occurring during the decision report phase .


A total of 173 participants in a Web-based experiment received information about four medical treatments , the best ( worst ) associated with mostly positive ( negative ) side-effects/attributes and the others with equal positive-negative ratios .


Next , participants were either distracted for 3 minutes ( unconscious thought ) , instructed to think about the information for 3 minutes ( conscious thought ) , or moved directly to the decision task ( immediate decision ) .


Finally , participants reported their choice of , and attitudes toward , the treatments while experiencing high , low , or no cognitive load , which varied their ability to think consciously while reporting judgments .


Cognitive load was manipulated by having participants memorize semi-random ( high ) , line structured ( low ) , or no dot patterns and recall these intermittently with their decision reports .


Overall then , participants were randomly assigned to the conditions of a 3 ( thought condition ) by 3 ( cognitive-load level ) between-subjects design .


A logistic regression analysis indicated that the odds of participants choosing the best treatment were 2.25 times higher in the unconscious-thought condition compared to the immediate-decision condition ( b = .81 , Wald = 4.32 , P = .04 , 95 % CI 1.048-4 .836 ) , and 2.39 times greater compared to the conscious-thought condition ( b = .87 , Wald = 4.87 , P = .027 , 95 % CI 1.103-5 .186 ) .


No difference was observed between the conscious-thought condition compared to the immediate-decision condition , and cognitive load manipulations did not affect choices or alter the above finding .


This research demonstrates a plausible benefit of unconscious thinking as a decision aid for complex medical decisions , and represents the first use of unconscious thought processes as a patient-centered medical decision aid .


Further , the quality of decisions reached unconsciously does not appear to be affected by the amount of cognitive load participants experienced .


the medications used according to the recommendation of the World Health Organization do not promote pain relief in a number of patients with cancer pain .


The aim of this study was to evaluate the use of morphine as first medication for the treatment of moderate cancer pain in patients with advanced and/or metastatic disease , as an option to the recommendations of the World Health Organization analgesic ladder .


sixty patients without opioid therapy , with 18 years of age , were randomized into two groups .


G1 patients received medication according to the analgesic ladder and started treatment with non-opioids in the first , weak opioids in the second , and strong opioids in the third step ; G2 patients received morphine as first analgesic medication .


The efficacy and tolerability of initial use of morphine were evaluated every two weeks for three months .


the groups were similar with respect to demographic data .


There was no significant difference between the groups regarding pain intensity , quality of life , physical capacity , satisfaction with treatment , need for complementation and dose of morphine .


In G1 there was a higher incidence of nausea ( p = 0.0088 ) , drowsiness ( p = 0.0005 ) , constipation ( p = 0.0071 ) and dizziness ( p = 0.0376 ) in the second visit and drowsiness ( p = 0.05 ) in the third .


the use of morphine as first medication for pain treatment did not promote better analgesic effect than the ladder recommended by World Health Organization , with higher incidence of adverse effects .


Simplification of antiretroviral therapy in patients with suppressed viremia may minimize long-term adverse effects .


The study 's primary objective was to determine whether abacavir/lamivudine + atazanavir ( ABC/3TC + ATV ) was virologically non-inferior to tenofovir/emtricitabine + atazanavir/ritonavir ( TDF/FTC + ATV/r ) over 24 weeks in a population of virologically suppressed , HIV-1 infected patients .


This open-label , multicenter , non-inferiority study enrolled antiretroviral experienced , HIV-infected adults currently receiving a regimen of TDF/FTC + ATV/r for 6 months with no history of virologic failure and whose HIV-1 RNA had been 75 copies/mL on 2 consecutive measurements including screening .


Patients were randomized 1 2 to continue current treatment or simplify to ABC/3TC + ATV .


The primary endpoint was the proportion of patients with HIV-RNA < 50 copies/mL at Week 24 by the Time to Loss of Virologic Response ( TLOVR ) algorithm .


Secondary endpoints included alternative measures of efficacy , adverse events ( AEs ) , and fasting lipids .


Exploratory endpoints included inflammatory , coagulation , bone , and renal biomarkers .


After 24 weeks , ABC/3TC + ATV ( n = 199 ) was non-inferior to TDF/FTC + ATV/r ( n = 97 ) by both the primary analysis ( 87 % in both groups ) and all secondary efficacy analyses .


Rates of grade 2-4 AEs were similar between the two groups ( 40 % vs 37 % , respectively ) , but an excess of hyperbilirubinemia made the rate of grade 3-4 laboratory abnormalities higher in the TDF/FTC + ATV/r group ( 30 % ) compared with the ABC/3TC + ATV group ( 13 % ) .


Lipid levels were stable except for HDL cholesterol , which increased significantly in the ABC/3TC + ATV group .


Bone and renal biomarkers improved significantly between baseline and Week 24 in patients taking ABC/3TC + ATV , and the difference between groups was significant at Week 24 .


No significant changes occurred in any inflammatory or coagulation biomarker within or between treatment groups .


After 24 weeks , simplification to ABC/3TC + ATV from TDF/FTC + ATV/r maintained viral suppression was well-tolerated , and led to improvements in bone and renal biomarkers and HDL cholesterol .


ClinicalTrials.gov NCT01102972 GlaxoSmithKline Clinical Study Register # 113734 .


Increased life expectancy has resulted in a greater provision of informal care within the community for patients with chronic physical health conditions .


Informal carers are at greater risk of poor mental health , with one in three informal carers of stroke survivors experiencing depression .


However , currently no psychological treatments tailored to the unique needs of depressed informal carers of stroke survivors exist .


Furthermore , informal carers of stroke survivors experience a number of barriers to attending traditional face-to-face psychological services , such as lack of time and the demands of the caring role .


The increased flexibility associated with supported cognitive behavioral therapy self-help ( CBTsh ) , such as the ability for support to be provided by telephone , email , or face-to-face , alongside shorter support sessions , may help overcome such barriers to access .


CBTsh , tailored to depressed informal carers of stroke survivors may represent an effective and acceptable solution .


This study is a Phase II ( feasibility ) randomized controlled trial ( RCT ) following guidance in the MRC Complex Interventions Research Methods Framework .


We will randomize a sample of depressed informal carers of stroke survivors to receive CBT self-help supported by mental health paraprofessionals , or treatment-as-usual .


Consistent with the objectives of assessing the feasibility of trial design and procedures for a potential larger scale trial we will measure the following outcomes : a ) feasibility of patient recruitment ( recruitment and refusal rates ) ; ( b ) feasibility and acceptability of data collection procedures ; ( c ) levels of attrition ; ( d ) likely intervention effect size ; ( e ) variability in number , length and frequency of support sessions estimated to bring about recovery ; and ( f ) acceptability of the intervention .


Additionally , we will collect data on the diagnosis of depression , symptoms of depression and anxiety , functional impairment , carer burden , quality of life , and stroke survivor mobility skill , self-care and functional ability , measured at four and six months post-randomization .


This study will provide important information for the feasibility and design of a Phase III ( effectiveness ) trial in the future .


If the intervention is identified to be feasible , effective , and acceptable , a written CBTsh intervention for informal carers of stroke survivors , supported by mental health paraprofessionals , could represent a cost-effective model of care .


Current Controlled Trials ISRCTN63590486 .


The purpose of this study was to investigate the effect of aerosolized fibrin sealant ( FS ) compared with that of polyvinyl acetal sponge packing on hemostasis and wound healing after functional endoscopic sinus surgery ( FESS ) .


We conducted a prospective randomized controlled trial of the use of aerosolized FS in 41 consecutive patients who underwent bilateral FESS between February 2011 and March 2012 .


The patients were randomized to receive FS applied via an aerosol spray in one nasal cavity and polyvinyl acetal sponge packing in the opposite cavity .


The patients were followed up at 1 , 2 , 4 , 8 , and 12 weeks postoperatively .


Crusting , adhesion , bleeding , granulation tissue formation , infection , and frontal sinus ostium stenosis after endoscopic surgery were assessed using a grading scale .


Subjective symptoms related to nasal packing were evaluated using questionnaires quantified by visual analog scales .


The degree of granulation and crusting was significantly reduced in the side treated with FS compared with the polyvinyl acetal sponge side , as were bleeding and pain during nasal packing removal ( p < 0.05 ) .


In addition , general satisfaction and willingness to reuse the material were significantly higher for the FS-treated side than for the polyvinyl acetal sponge-packed side ( p < 0.001 ) .


Compared with polyvinyl acetal sponge , aerosolized FS shows beneficial effects on hemostasis and wound healing after FESS .


The application of FS resulted in a high degree of patient satisfaction without additional morbidity .


People infected with the human immunodeficiency virus are at an increased risk of developing ischemic heart disease ( IHD ) ; however , the effects of an education and home-based pedometer walking program on risk factors of IHD are not known .


We conducted a 12-month randomized study of an education and home-based pedometer walking program in 84 human immunodeficiency virus-infected individuals with risk factors of IHD .


Pedometer step count of the control and intervention groups improved significantly ( P = 0.03 for both groups ) at 6 months but was not significant at 12 months ( P = 0.33 and 0.21 , respectively ) .


Significant between-group effects were observed in 6-minute walk test distance ( P = 0.01 ) , waist to hip ratio ( P = 0.00 ) , glucose ( P = 0.00 ) , and high-density lipoprotein ( P = 0.01 ) over the 12-month period .


The program did not result in change in high-sensitivity C-reactive protein as it was associated with perceived stress ( r = 0.23 ; P = 0.03 ) , weight ( r = 0.28 ; P = 0.01 ) , body mass index ( r = 0.35 ; P < 0.00 ) , waist ( r = 0.28 ; P = 0.01 ) and hip circumference ( r = 0.28 ; P = 0.01 ) .


Multivariate generalized estimation equation analysis demonstrated an inverse association between interaction and perceived stress ( logB = -0.01 ; 95 % confidence interval : -0.02 to -0.01 ; P < 0.00 ) and body mass index ( logB = -0.02 ; 95 % confidence interval : -0.03 to -0.002 ; P = 0.02 ) at group level .


An education and home-based pedometer walking program improves physical activity levels , and beneficial changes in other IHD risk factors were noted .


At the time of the initial analysis of overall survival ( OS ) for the Comparison of Faslodex in Recurrent or Metastatic Breast Cancer ( CONFIRM ) randomized , double-blind , phase III trial , approximately 50 % of patients had died .


A final analysis of OS was subsequently planned for when 75 % of patients had died .


Patients were randomly assigned 1:1 to fulvestrant 500 mg administered as two 5-mL intramuscular injections on days 0 , 14 , and 28 and every 28 ( 3 ) days thereafter or fulvestrant 250 mg administered as two 5-mL intramuscular injections ( one fulvestrant and one placebo [ identical in appearance to study drug ] ) on days 0 , 14 ( two placebo injections only ) , and 28 and every 28 ( 3 ) days thereafter .


OS was analyzed using an unadjusted log-rank test .


No adjustments were made for multiplicity .


Serious adverse events ( SAEs ) and best response to subsequent therapy were also reported .


All statistical tests were two-sided .


In total , 736 women ( median age = 61.0 years ) were randomly assigned to fulvestrant 500 mg ( n = 362 ) or 250 mg ( n = 374 ) .


At the final survival analysis , 554 of 736 ( 75.3 % ) patients had died .


Median OS was 26.4 months for fulvestrant 500 mg and 22.3 months for 250 mg ( hazard ratio = 0.81 ; 95 % confidence interval = 0.69-0 .96 ; nominal P = .02 ) .


There were no clinically important differences in SAE profiles between the treatment groups ; no clustering of SAEs could be detected in either treatment group .


Type of first subsequent therapy and objective responses to first subsequent therapy were well balanced between the two treatment groups .


In patients with locally advanced or metastatic estrogen receptor-positive breast cancer , fulvestrant 500 mg is associated with a 19 % reduction in risk of death and a 4.1-month difference in median OS compared with fulvestrant 250 mg .


Fulvestrant 500 mg was well tolerated , and no new safety concerns were identified .


The purpose of this study was to compare the use of amoxicillin ( 1g ) vs amoxicillin and clavulanate ( 875/125mg ) after extraction of retained third molars for prevention of infectious complications .


The study involved 546 patients attending for removal a retained third molar and divided in to two groups : Group 1 - amoxicillin and clavunate ( 875/125mg ) group ( n = 257 ) and Group 2 - amoxicillin ( 1g ) group ( n = 289 ) .


All patients were recalled for investigating the possibility of infection , presence of diarrhea and further analgesic intake .


From a total of 546 patients , the frequency of infection was 1.4 % , without no statistically differences between the two groups .


Group 1 showed statistically higher presence of patients with gastrointestinal complications ( p > 0.05 ) .


In 546 patients , 2.7 % of patients reported severe pain that would not relieve with medication .


The results of our study show that the use of amoxicillin ( 1g ) and amoxicillin and clavunate ( 875/125mg ) is similar efficacious in preventing infection after retained third molar extraction but amoxicillin and clavunate ( 875/125mg ) produces more gastrointestinal discomfort .


The prevalence and consequences of musculoskeletal pain is considerable among healthcare workers , allegedly due to high physical work demands of healthcare work .


Previous investigations have shown promising results of physical exercise for relieving pain among different occupational groups , but the question remains whether such physical exercise should be performed at the workplace or conducted as home-based exercise .


Performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase adherence .


On the other hand , physical exercise performed during working hours at the workplace may be costly for the employers in terms of time spend .


Thus , it seems relevant to compare the efficacy of workplace - versus home-based training on musculoskeletal pain .


This study is intended to investigate the effect of workplace-based versus home-based physical exercise on musculoskeletal pain among healthcare workers .


This study was designed as a cluster randomized controlled trial performed at 3 hospitals in Copenhagen , Denmark .


Clusters are hospital departments and hospital units .


Cluster randomization was chosen to increase adherence and avoid contamination between interventions .


Two hundred healthcare workers from 18 departments located at three different hospitals is allocated to 10weeks of 1 ) workplace based physical exercise performed during working hours ( using kettlebells , elastic bands and exercise balls ) for 510minutes per week and up to 5 group-based coaching sessions , or 2 ) home based physical exercise performed during leisure time ( using elastic bands and body weight exercises ) for 510minutes per week .


Both intervention groups will also receive ergonomic instructions on patient handling and use of lifting aides etc. .


Inclusion criteria are female healthcare workers working at a hospital .


Average pain intensity ( VAS scale 0-10 ) of the back , neck and shoulder ( primary outcome ) and physical exertion during work , social capital and work ability ( secondary outcomes ) is assessed at baseline and 10-week follow-up .


Further , postural balance and mechanical muscle function is assessed during clinical examination at baseline and follow-up .


This cluster randomized trial will investigate the change in self-rated average pain intensity in the back , neck and shoulder after either 10 weeks of physical exercise at the workplace or at home .


ClinicalTrials.gov ( NCT01921764 ) .


We compared the analgesic effects of caudal and ilioinguinal-iliohypogastric nerve block using bupivacaine-clonidine performed in children undergoing inguinal hernia repair .


The ilioinguinal-iliohypogastric nerve block provides excellent pain relief for operations on the inguinal region , including emergency procedures ( e.g. strangulated inguinal hernia with intestinal obstruction ) .


It should be preferred to caudal block for these procedures .


After local ethics committee approval and written parental consent , 67 ASA class I - II patients aged between 2-7 years old scheduled for elective inguinal hernia repair were allocated randomly into two groups after general anesthesia with same drugs in both groups .


Group C received caudal block with 1 ml/kg bupivacaine 0.25 % combined with 1 g/kg clonidine , and group I received ilioinguinal - iliohypogastric nerve block with 0.3 ml / kg bupivacaine 0.25 % combined with 1 g/kg clonidine .


Blood pressure and heart rate were documented every 5 minutes .


Post-operative analgesia , analgesic use and side-effects were assessed during first 24 hours .


In group C , 7 / 34 and in group I , 12/33 patients required post-operative analgesia ( P = 0.174 ) .


Five patients ( 15.5 % ) in group I and one patient ( 2.94 % ) in group C had severe pain after operation .


Systolic and diastolic blood pressure decreased during operation , but the differences between two groups were not significant ( P = 0.176 , P = 0.111 ) .


Heart rate changes between two groups were insignificant ( P = 0.182 ) .


It seems that in children , caudal epidural block and ilioinguinal - iliohypogastric nerve block using bupivacaine-clonidine have comparable effects on analgesia , severity of pain and hemodynamic changes during and after surgery on inguinal region .


Work and being able to work are important prerequisites for health and well being .


Health problems can have a negative influence on the ability to work and not being able to work can be detrimental for patients ' psychosocial well being .


Although GPs are aware of this importance they do not always structurally pay attention to patients ' work during their daily practice .


To investigate whether GPs can be trained to increase their awareness of work and improve their skills when dealing with work related problems we designed a cluster randomised controlled trial .


The intervention in this trial is a tailored training based on the findings of qualitative research with focus groups of GPs .


Gender aspects received specific attention in these focus groups .


Primary outcome measures are self efficacy of patients concerning return to work , and GPs ' use of ICPC code Z05 ( work problems ) and registration of patients ' occupation .


Secondary outcome measures are work awareness of GPs as perceived by patients , quality of life , health , use of care and illness related costs .


A process evaluation will be part of our study .


We investigate a training to increase work awareness among GPs , improve their skills in managing work related problems and structurally register work related data in the EMR .


We think this study will make a contribution to better health care for workers by motivating GPs to appreciate their specific needs .


It will also add to our knowledge of the complex relationship between gender , work and health .


Diabetes mellitus may be present in patients with cystic fibrosis starting in the second decade of life .


The prevalence increases rapidly with increasing age .


As life-expectancy increases in cystic fibrosis , cystic fibrosis related diabetes will be diagnosed more frequently in the future.Up to date , no data are available to answer the question if cystic fibrosis related diabetes should always initially be treated by insulin therapy .


Missing data regarding oral antidiabetic treatment of newly diagnosed cystic fibrosis related diabetes are an important reason to recommend insulin treatment .


Several centres report the successful management of cystic fibrosis related diabetes using oral anti-diabetic drugs at least for some years .


Oral therapies would be less invasive for a patient group which is highly traumatized by a very demanding therapy .


Based on an initiative of the German Mukoviszidosis-Foundation , the present study tries to answer the question , whether oral therapy with repaglinide is as effective as insulin therapy in cystic fibrosis patients with early diagnosed diabetes mellitus .


In all cystic fibrosis patients with an age of 10 years or older , an oral glucose tolerance test is recommended .


The result of this test is classified according to the WHO cut off values .


It is required to have two diabetes positive oral glucose tolerance tests for the diagnosis of diabetes mellitus.This study is a multi-national , multicentre , open labelled , randomized and prospective controlled parallel group 's trial , with 24 months treatment.The primary objective of this trial is to compare the glycaemic control of oral therapy with Repaglinide with insulin injections in patients with cystic fibrosis related diabetes after 2 years of treatment.The trial should include 74 subjects showing cystic fibrosis related diabetes newly diagnosed by oral glucose tolerance test during annual screening for cystic fibrosis related diabetes.Patients are randomised by central fax randomisation.Primary endpoint is mean HbA1c after 24 months of treatment .


Secondary endpoints are change in FEV1 % predicted and change in BMI-Z-score .


There is only one prospective study comparing oral antidiabetic drugs to insulin in the treatment of CFRD without fasting hyperglycaemia .


The results regarding BMI after 6 months and 12 months showed an improvement for the insulin treated patients and were inconsistent for those treated with repaglinide .


HbA1c and lung function ( FEV1 % pred ) were unchanged for either group .


The authors compared the changes -12 months to baseline and baseline to +12 months separately for each group .


Therefore a direct comparison of the effect of repaglinide versus insulin on BMI , HbA1c and FEV1 % pred was not presented .


According to our protocol , we will directly compare treatment effects ( HbA1c , BMI , FEV1 % pred ) in between both groups .


The actual Cochrane report regarding `` Insulin and oral agents for managing CFRD '' stated that further studies are needed to establish whether there is clear benefit for hypoglycemic agents .


We expect that the results of our study will help to address this clinical need .


ClinicalTrials.gov Identifier : NCT00662714 .


Calcium from different dairy sources might affect blood lipids and fecal fat excretion differently because of differences in the food matrix and nutritional composition .


We investigated whether milk - and cheese-based diets with similar calcium contents affect a saturated fatty acid-induced increase in blood lipids differently .


Fifteen healthy , young men participated in a randomized 3 2-wk crossover study in which the following 3 isocaloric diets that were similar in fat contents and compositions were compared : control diet [ nondairy diet ( ~ 500 mg Ca/d ) ] , milk diet [ semiskimmed milk-based diet ( 1700 mg Ca/d ) ] , and cheese diet [ semihard cow-cheese-based diet ( 1700 mg Ca/d ) ] .


Blood was drawn before and after each period , and feces were collected for 5 d during each period .


Saturated fatty acid-induced increases in total and low-density lipoprotein ( LDL ) cholesterol were lower with the milk diet ( mean SD : 0.57 0.13 and 0.53 0.11 mmol/L , respectively ) ( P < 0.01 ) and cheese diet ( 0.41 0.15 and 0.47 0.12 mmol/L , respectively ) ( P < 0.05 ) than with the control diet ( 0.89 0.12 and 0.84 0.11 mmol/L , respectively ) .


Fecal fat excretion increased more with the consumption of both the milk ( 5.2 0.4 g/d ) and cheese ( 5.7 0.4 g/d ) diets than with the control diet ( 3.9 0.3 g/d ) ( P < 0.001 ) .


Changes in blood pressure , high-density lipoprotein cholesterol , triglycerides , and lipid ratios did not differ .


Compared with the control diet , milk - and cheese-based diets attenuated saturated fatty acid-induced increases in total and LDL cholesterol and resulted in increased fecal fat excretion ; however , effects of milk and cheese did not differ .


Because the diets contained similar amounts of saturated fat , similar increases in total and LDL cholesterol could be expected ; however , both milk and cheese attenuated these responses , which seem to be explained by their calcium contents .


This trial was registered at clinicaltrials.gov as NCT01317251 .


The aim of this study was to evaluate the effectiveness of middle turbinate radiofrequency ( RF ) turbinoplasty for the management of the polypoid middle turbinate compared to middle turbinate resection and middle turbinate medialization .


The study was performed on 90 patients at a tertiary referral hospital with nasal polyposis resistant to maximal medical treatment .


At the time of functional endoscopic sinus surgery ( FESS ) , patients were randomized into 3 groups with respect to the management of the middle turbinate : middle turbinate turbinoplasty by RF ; partial resection of the middle turbinate ; and medialization of the middle turbinate by scarification to the septum .


We evaluated the patients ' symptoms according to the 22-item Sino-Nasal Outcome Test ( SNOT-22 ) preoperatively and 1 year after surgery .


Additionally , polyp recurrence and complications were compared among the 3 groups .


One year after surgery , there was no significant difference in SNOT-22 scores between the groups .


However , the RF group had a significantly lower polyp recurrence rate when compared to other groups ( p < 0.05 ) .


RF middle turbinate turbinoplasty could be considered an alternative to other common approaches , but it needs further long-term studies before widespread usage .


Addition of a MEK inhibitor to a BRAF inhibitor enhances tumour growth inhibition , delays acquired resistance , and abrogates paradoxical activation of the MAPK pathway in preclinical models of BRAF-mutated melanoma .


We assessed the safety and efficacy of combined BRAF inhibition with vemurafenib and MEK inhibition with cobimetinib in patients with advanced BRAF-mutated melanoma .


We undertook a phase 1b study in patients with advanced BRAF ( V600 ) - mutated melanoma .


We included individuals who had either recently progressed on vemurafenib or never received a BRAF inhibitor .


In the dose-escalation phase of our study , patients received vemurafenib 720 mg or 960 mg twice a day continuously and cobimetinib 60 mg , 80 mg , or 100 mg once a day for either 14 days on and 14 days off ( 14/14 ) , 21 days on and 7 days off ( 21/7 ) , or continuously ( 28/0 ) .


The primary endpoint was safety of the drug combination and to identify dose-limiting toxic effects and the maximum tolerated dose .


Efficacy was a key secondary endpoint .


All patients treated with vemurafenib and cobimetinib were included in safety and efficacy analyses ( intention-to-treat ) .