Although the randomized controlled study did not show that the virtual patient simulation was superior to mannequin-based simulation , both simulations have demonstrated to be effective refresher learning strategies for improving nursing students ' clinical performance .


Given the greater resource requirements of mannequin-based simulation , the virtual patient simulation provides a more promising alternative learning strategy to mitigate the decay of clinical performance over time .


Caloric restriction ( CR ) , energy intake reduced below ad libitum ( AL ) intake , increases life span in many species .


The implications for humans can be clarified by randomized controlled trials of CR .


To determine CR 's feasibility , safety , and effects on predictors of longevity , disease risk factors , and quality of life in nonobese humans aged 21-51 years , 218 persons were randomized to a 2-year intervention designed to achieve 25 % CR or to AL diet .


Outcomes were change from baseline resting metabolic rate adjusted for weight change ( `` RMR residual '' ) and core temperature ( primary ) ; plasma triiodothyronine ( T3 ) and tumor necrosis factor - ( secondary ) ; and exploratory physiological and psychological measures .


Body mass index averaged 25.1 ( range : 21.9-28 .0 kg/m ( 2 ) ) .


Eighty-two percent of CR and 95 % of AL participants completed the protocol .


The CR group achieved 11.70.7 % CR ( mean standard error ) and maintained 10.40.4 % weight loss .


Weight change in AL was negligible .


RMR residual decreased significantly more in CR than AL at 12 months ( p = .04 ) but not 24 months ( M24 ) .


Core temperature change differed little between groups .


T3 decreased more in CR at M12 and M24 ( p < .001 ) , while tumor necrosis factor - decreased significantly more only at M24 ( p = .02 ) .


CR had larger decreases in cardiometabolic risk factors and in daily energy expenditure adjusted for weight change , without adverse effects on quality of life .


Sustained CR is feasible in nonobese humans .


The effects of the achieved CR on correlates of human survival and disease risk factors suggest potential benefits for aging-related outcomes that could be elucidated by further human studies .


Although scientific knowledge about the benefits of probiotic use in cystis fibrosis ( CF ) is scarce , their expectative is promising .


The aim of this work was to analyze the effect of a Lactobacillus reuteri probiotic preparation versus placebo in CF patients .


A prospective , double blind , crossover and with placebo study was carried out in 30 CF patients from two Spanish hospitals .


Patients were randomized in Group A ( 6 months of probiotic followed by 6 months of placebo ) and Group B ( 6 months of placebo followed by 6 months of probiotic ) .


GIQLI ( gastrointestinal ) and SF-12 ( general ) health tests were performed after probiotic and placebo intakes .


Fat absorption coefficient , calprotectin , and inflammatory interleukin quantification were determined in fecal samples .


Total fecal DNA was obtained and metagenomic 454-pyrosequencing was applied to analyze the microbiome composition .


STATA v12 MP software was used for statistical analyses .


Statistically significant improvement in the gastrointestinal health and decrease of the calprotectin levels were demonstrated in patients after probiotic exposure , in comparison with placebo .


All CF subjects reported good tolerance to L. reuteri without secondary effects .


Metagenomic analysis showed an important dysbiosis in CF gut microbiota associated with a high concentration of Proteobacteria .


Probiotic intake was followed by a reduction in the total bacterial density , mostly due to a considerable reduction in the - Proteobacteria phylum ; and an important increase of the microbial diversity with a higher representation of Firmicutes .


Probiotics might ameliorate the dysbiosis of CF gut microbiota , characterized by a high density of Proteobacterial organisms .


L. reuteri significantly decrease intestinal inflammation and increase digestive comfort .


The magnitude of effect of sublingual immunotherapy for house dust mite ( HDM ) - induced allergic rhinitis with or without conjunctivitis is uncertain , partly because there are few well-controlled trials with well-defined doses .


We sought to determine the dose-related efficacy and onset of action of the HDM sublingual immunotherapy tablet MK-8237 ( Merck/ALK-Abell ) using the Vienna Challenge Chamber .


In this randomized , double-blind , single-site trial , adults with HDM-induced allergic rhinitis with or without conjunctivitis and with or without asthma ( n = 124 ) received 12 developmental units ( DU ) of MK-8237 , 6 DU of MK-8237 , or placebo daily for 24 weeks .


Subjects underwent 6-hour exposure challenges at screening and weeks 8 , 16 , and 24 .


The total nasal symptom score ( TNSS ) during chamber challenge at week 24 was the primary end point .


The TNSS was the sum of 4 nasal symptom scores ( maximum = 12 ) .


Total ocular symptom scores ( TOSSs ; 2 symptoms ; maximum = 6 ) and total symptom scores ( TSSs ; TSS = TNSS plus TOSS ; maximum = 18 ) were secondary end points .


Dose - and time-dependent improvements with MK-8237 versus placebo were observed .


At week 24 , TNSS improvement relative to placebo was 48.6 % ( 95 % CI , 35.3 % to 60.2 % ) with 12 DU of MK-8237 and 26.6 % ( 95 % CI , 11.2 % to 39.6 % ) with 6 DU of MK-8237 .


Statistically significant improvements for TNSSs were also observed at weeks 8 ( 12 DU of MK-8237 ) and 16 ( 6 and 12 DU of MK-8237 ) and for TOSSs and TSSs by both doses at week 24 .


MK-8237 was well tolerated .


No investigator-assessed anaphylactic allergic reactions or reactions requiring epinephrine were observed .


MK-8237 , 12 DU , reduced nasal and ocular symptoms and exceeded World Allergy Organization-established clinical efficacy criteria ( 20 % improvement vs placebo ) .


The onset of action for 12 DU of MK-8237 was week8.MK-8237 , 12 DU , is appropriate for further evaluation to determine the magnitude of effect in an uncontrolled allergenexposure environment .


Oesophageal cancer presents high incidence rates in the so-called Brazilian-Uruguayan belt .


The present study included 1,170 participants ( 234 cases and 936 controls ) which were analyzed by unconditional multiple logistic regression in order to examine risk of oesophageal squamous cell carcinoma ( OESCC ) associated with several food groups .


Boiled red meat ( OR 2.59 , 95 % CI 1.69-3 .97 ) , lamb meat ( OR 1.64 , 95 % CI 1.07-2 .51 ) , processed meat ( OR 1.49 , 95 % CI 1.01-2 .21 ) , whole milk ( OR 1.78 , 1.19-1 .68 ) , fresh vegetables and fruits ( OR 0.42 , 95 % CI 0.27-0 .63 ) , mate consumption ( OR 2.04 , 95 % CI 1.32 - 3.16 ) , and black tea ( OR 0.10 , 95 % CI 0.04-0 .28 ) were significantly associated with risk of OESCC .


Hot beverages ( mate ) and hot foods ( boiled meat ) appear to be important determinants in the risk of OESCC , allowing the penetration of carcinogens in tobacco and alcohol into the oesophageal mucosa .


Despite the growing interest in the early-origins-of-later-disease hypothesis , little is known about the metabolic underpinnings linking infant weight gain and childhood obesity .


To discover biomarkers reflective of weight change in the first 6 months and overweight/obesity at age 6 years via a targeted metabolomics approach .


This analysis comprised 726 infants from a European multicenter randomized trial ( Childhood Obesity Programme , CHOP ) for whom plasma blood samples at age 6 months and anthropometric data up to the age of 6 years were available .


` Rapid growth ' was defined as a positive difference in weight within the first 6 months of life standardized to WHO growth standards .


Weight change was regressed on each of 168 metabolites ( acylcarnitines , lysophosphatidylcholines , sphingomyelins , and amino acids ) .


Metabolites significant after Bonferroni 's correction were tested as predictors of later overweight/obesity .


Among the overall 19 significant metabolites , 4 were associated with rapid growth and 15 were associated with a less-than-ideal weight change .


After adjusting for feeding group , only the lysophosphatidylcholine LPCaC14 :0 remained significantly associated with rapid weight gain ( = 0.18 ) .


Only LPCaC14 :0 at age 6 months was predictive of overweight/obesity at age 6 years ( OR 1.33 ; 95 % CI 1.04-1 .69 ) .


LPCa14 :0 is strongly related to rapid growth in infancy and childhood overweight/obesity .


This suggests that LPCaC14 :0 levels may represent a metabolically programmed effect of infant weight gain on the later obesity risk .


However , these results require confirmation by independent cohorts .


To study the clinical effectiveness of biofeedback treatment in reducing tics in patients with Tourette syndrome .


Despite advances in the pharmacologic treatment of patients with Tourette syndrome , many remain troubled by their tics , which may be resistant to multiple medications at tolerable doses .


Electrodermal biofeedback is a noninvasive biobehavioral intervention that can be useful in managing neuropsychiatric and neurologic conditions .


We conducted a randomized controlled trial of electrodermal biofeedback training in 21 patients with Tourette syndrome .


After training the patients for 3 sessions a week over 4 weeks , we observed a significant reduction in tic frequency and improved indices of subjective well-being in both the active-biofeedback and sham-feedback ( control ) groups , but there was no difference between the groups in these measurements .


Furthermore , the active-treatment group did not demonstrably learn to reduce their sympathetic electrodermal tone using biofeedback .


Our findings indicate that this form of biofeedback training was unable to produce a clinical effect greater than placebo .


The main confounding factor appeared to be the 30-minute duration of the training sessions , which made it difficult for patients to sustain a reduction in sympathetic tone when their tics themselves were generating competing phasic electrodermal arousal responses .


Despite a negative finding in this study , electrodermal biofeedback training may have a role in managing tics if optimal training schedules can be identified .


To measure the pH , titratable acidity , fluoride concentration and erosive potential of brewed teas .


Bag teas were purchased to represent black , green , citrus , fruity , and floral tea flavors from Tulsi , Bigelow , HyVee , Tazo , and Yogi brands and brewed ( 1 bag/240 ml ) in boiling water for 3 minutes .


The pH , titratable acidity , and fluoride concentrations were measured .


Following these measurements , a representative tea from each flavor was selected for investigation of erosion potential .


Six extracted human molars were randomly assigned to each tea .


Teeth were painted with fingernail polish to expose a 1 x 4 mm window and then soaked in tea for a total of 25 hours with teas refreshed every 5 hours .


Teeth were then sectioned using a microtome and photographed using a polarized light microscope .


Lesion depths ( i.e. , eroded surfaces ) were measured using Image Pro Plus software .


Differences in physiochemical properties and lesion depths between beverages were investigated using one-way ANOVA with post-hoc Tukey 's HSD test .


Relationships among lesion depths and physiochemical properties were evaluated using the Pearson correlation test .


pH , titratable acidity and fluoride concentrations differed between tea flavors ( P < 0.05 ) and between brands ( P < 0.05 ) .


Lesion depths produced by the citrus tea ( 83.1 + / - 10.3 microm ) were greater than those produced by the fruity tea ( 56.5 + / - 6.1 microm ) ; both teas produced greater depths than black ( 30.1 + / - 7.4 microm ) , floral ( 25.0 + / - 3.2 microm ) or green ( 22.3 + / - 6.3 microm ) teas ( P < 0.05 ) .


pH ( r = -0.96 ; P = 0.009 ) was inversely and titratable acidity ( r = 0.97 ; P = 0.006 ) was positively associated with lesion depths .


Anti-HER2 / neu therapy is well-established in breast and gastric carcinoma .


The increased understanding of this pathway led to the identification of new promising drugs in addition to trastuzumab , offering further perspectives .


The role of HER2/neu in colorectal carcinoma is controversially discussed , as discrepant data has been reported .


Here , we retrospectively assessed the prevalence of HER2/neu positivity in a large series of colorectal carcinoma , testing HER2/neu status according to current recommendations .


We correlated the results to clinico-pathological data and patient survival .


Overall , in 1645 primary colorectal carcinoma cases , 1.6 % of the cases were HER2/neu positive .


HER2/neu positivity significantly correlated with higher UICC stages ( P = 0.017 ) and lymph node metastases ( P = 0.029 ) .


In the subgroup of sigmoideal and rectal carcinomas , positive HER2/neu status was associated with T-category ( P = 0.041 ) and higher UICC stages ( P = 0.022 ) .


Although statistically not significant , HER2/neu-positive colorectal carcinomas displayed a tendency to poorer overall survival .


These results illustrate the importance of testing HER2/neu by approved diagnostic techniques and scoring systems .


We assume that although the prevalence of HER2/neu positivity in colorectal carcinoma is low , HER2/neu testing in advanced , nodal-positive colorectal carcinoma is reasonable , offering a potential target in high risk colorectal carcinoma .


After stroke , does treadmill training provide greater benefit to the subgroup of community-dwelling people who walk faster than 0.4 m/s than those who walk more slowly ?


Subgroup analysis of a randomised trial : the AMBULATE trial .


68 people with stroke living in the community .


The experimental group received 30 minutes of treadmill and overground walking , three times a week for four months ; the control group received no intervention .


The primary outcome was walking distance covered during the six-minute walk test .


Other outcomes were comfortable and fast walking speed and health status .


At four months , in the subgroup of participants with a baseline comfortable walking speed of > 0.4 m/s , treadmill training produced an extra distance of 72m ( 95 % CI 23 to 121 ) and an increased comfortable speed of 0.16 m/s ( 95 % CI 0.00 to 0.32 ) , compared with the subgroup with a speed of 0.4 m/s .


There was also a trend towards an extra fast speed of 0.17 m/s ( 95 % CI -0.04 to 0.36 ) .


There was no extra effect of treadmill training in the faster walkers in terms of EuroQol 5Q-5D .


There were no differences between the experimental and control groups between subgroups in the long term .


Treadmill training is more likely to benefit people who walk at a speed of > 0.4 m/s .


Clinicians should use comfortable walking speed to predict the potential for improvement and to guide intervention .


ACTRN12607000227493 .


No study has investigated whether pioglitazone ( an agonist of peroxisome proliferator-activated receptor gamma ) protects against ischemia and reperfusion ( IR ) - induced endothelial dysfunction in humans .


In the first crossover study , 20 volunteers were randomized to 1 week of pioglitazone ( 30 mg/d , postoperatively ) or control ( no treatment ) .


In the second single-arm study , 15 volunteers received pioglitazone and the cyclooxygenase-2 inhibitor meloxicam for 1 week .


On day 7 , endothelium-dependent flow-mediated dilation ( FMD ) of the distal brachial artery was measured before and after IR ( 15 minutes of ischemia followed by 15 minutes of reperfusion in the proximal upper arm ) .


Pre-IR brachial-artery diameter and FMD were similar across the 2 sessions ( control , pioglitazone ) in protocol 1 and between the 2 protocols .


IR significantly blunted FMD after no treatment ( pre-IR FMD : 10.2 % 2.6 % ; post-IR FMD : 3.5 % 1.9 % , P < 0.01 ) but not after pioglitazone administration ( pre-IR FMD : 9.7 % 2.5 % ; post-IR FMD : 8.8 % 2.9 % , P = 0.11 ) .


This protective effect was accompanied by an increase in serum levels of the antioxidant enzyme extracellular superoxide dismutase and was not affected by concomitant administration of the cyclooxygenase-2 inhibitor meloxicam ( P = 0.10 ) .


In humans , pioglitazone provides potent protection against IR-induced endothelial dysfunction .


Vascular cognitive impairment , no dementia ( VCIND ) is a condition at risk for future dementia and should be the target of preventive strategies .


Preliminary evidence suggests that acupuncture may be a clinically effective intervention for people with early-stage vascular cognitive impairment .


We will do a multicenter , 6-month , drug-controlled , nonblinded , randomized , parallel-group trial to determine whether acupuncture is effective for improving cognitive function and quality of life for patients with VCIND .


A total of 216 eligible patients will be recruited and randomly assigned acupuncture for two sessions/week ( n = 108 ) or citicoline 300 mg/day ( n = 108 ) in a multicenter , 6-month trial .


The primary endpoint is cognition ( Alzheimer 's Disease Assessment Scale , Cognitive Subscale ( ADAS-cog ) ) .


Secondary endpoints include assessments of activities of daily living and behavioral symptoms ( Clock Drawing Test ( CDT ) , Activities of Daily Living ( ADL ) and Instrumental Activities of Daily Living scale ( IADL ) ) .


This will be the first large-scale trial specifically evaluating acupuncture therapy in VCIND .


If the study confirms the effectiveness and safety of acupuncture treatment , it will be important to examine how the acupuncture approach could most effectively be integrated into the provision of routine healthcare .


This study is registered as an International Standard Randomised Controlled Trial on 17 January 2014 , number ISRCTN 82980206 .


Death rates due to hypertension in low and middle income countries are higher compared to high income countries .


The present study is designed to combine life style modification and home blood pressure monitoring for control of hypertension in the context of low and middle income countries .


The study is a two armed , parallel group , un-blinded , cluster randomized controlled trial undertaken within lower income areas in Kuala Lumpur .


Two housing complexes will be assigned to the intervention group and the other two housing complexes will be allocated in the control group .


Based on power analysis , 320 participants will be recruited .


The participants in the intervention group ( n = 160 ) will undergo three main components in the intervention which are the peer support for home blood pressure monitoring , face to face health coaching on healthy diet and demonstration and training for indoor home based exercise activities while the control group will receive a pamphlet containing information on hypertension .


The primary outcomes are systolic and diastolic blood pressure .


Secondary outcome measures include practice of self-blood pressure monitoring , dietary intake , level of physical activity and physical fitness .


The present study will evaluate the effect of lifestyle modification and peer support home blood pressure monitoring on blood pressure control , during a 6 month intervention period .


Moreover , the study aims to assess whether these effects can be sustainable more than six months after the intervention has ended .


Time to thrombolysis is crucial for outcome in acute ischemic stroke .


To determine if starting thrombolysis in a specialized ambulance reduces delays .


In the Prehospital Acute Neurological Treatment and Optimization of Medical care in Stroke Study ( PHANTOM-S ) , conducted in Berlin , Germany , we randomly assigned weeks with and without availability of the Stroke Emergency Mobile ( STEMO ) from May 1 , 2011 , to January 31 , 2013 .


Berlin has an established stroke care infrastructure with 14 stroke units .


We included 6182 adult patients ( STEMO weeks : 44.3 % male , mean [ SD ] age , 73.9 [ 15.0 ] y ; control weeks : 45.2 % male , mean [ SD ] age , 74.3 [ 14.9 ] y ) for whom a stroke dispatch was activated .


The intervention comprised an ambulance ( STEMO ) equipped with a CT scanner , point-of-care laboratory , and telemedicine connection ; a stroke identification algorithm at dispatcher level ; and a prehospital stroke team .


Thrombolysis was started before transport to hospital if ischemic stroke was confirmed and contraindications excluded .


Primary outcome was alarm-to-thrombolysis time .


Secondary outcomes included thrombolysis rate , secondary intracerebral hemorrhage after thrombolysis , and 7-day mortality .


Time reduction was assessed in all patients with a stroke dispatch from the entire catchment area in STEMO weeks ( 3213 patients ) vs control weeks ( 2969 patients ) and in patients in whom STEMO was available and deployed ( 1804 patients ) vs control weeks ( 2969 patients ) .


Compared with thrombolysis during control weeks , there was a reduction of 15 minutes ( 95 % CI , 11-19 ) in alarm-to-treatment times in the catchment area during STEMO weeks ( 76.3 min ; 95 % CI , 73.2-79 .3 vs 61.4 min ; 95 % CI , 58.7-64 .0 ; P < .001 ) .


Among patients for whom STEMO was deployed , mean alarm-to-treatment time ( 51.8 min ; 95 % CI , 49.0-54 .6 ) was shorter by 25 minutes ( 95 % CI , 20-29 ; P < .001 ) than during control weeks .


Thrombolysis rates in ischemic stroke were 29 % ( 310/1070 ) during STEMO weeks and 33 % ( 200/614 ) after STEMO deployment vs 21 % ( 220/1041 ) during control weeks ( differences , 8 % ; 95 % CI , 4 % -12 % ; P < .001 , and 12 % , 95 % CI , 7 % -16 % ; P < .001 , respectively ) .


STEMO deployment incurred no increased risk for intracerebral hemorrhage ( STEMO deployment : 7/200 ; conventional care : 22/323 ; adjusted odds ratio [ OR ] , 0.42 , 95 % CI , 0.18-1 .03 ; P = .06 ) or 7-day mortality ( 9/199 vs 15/323 ; adjusted OR , 0.76 ; 95 % CI , 0.31-1 .82 ; P = .53 ) .


Compared with usual care , the use of ambulance-based thrombolysis resulted in decreased time to treatment without an increase in adverse events .


Further studies are needed to assess the effects on clinical outcomes .


clinicaltrials.gov Identifier : NCT01382862 .


To evaluate and compare the 3-year clinical performance of a silorane-based composite with that of a methacrylate-based composite in Class II restorations .


Seventy-eight patients , each with two class II restorations under occlusion , were enrolled in this study .


One hundred fifty-six restorations were placed , 50 % for each material : a silorane-based composite , Filtek P90 / P90 System Adhesive and a methacrylate-based resin composite , Quixfil / Prime & Bond NT .


A single operator placed all restorations according to the manufacturers ' instructions .


Immediately after placement , the restorations were finished/polished .


Clinical evaluation was performed at baseline and at yearly intervals after placement by two other independent examiners using slightly modified USPHS criteria .


The changes in the USPHS parameters during the three-year period were analyzed with the Friedman test .


The baseline scores were compared with those at the recall visits using the Wilcoxon signed rank test .


The level of significance was set at p < 0.05 .


All restorations were evaluated at 3 years .


Post-operative sensitivity was observed in 6 patients ( 2 Filtek P90 , 4 Quixfil ) between 1 and 3 weeks .


Seven failed restorations ( 4.5 % ) were observed during the follow up : 4 in the Filtek P90 ( 5.1 % ) and 3 in the Quixfil group ( 3.8 % ) .


This resulted in non-significantly different annual failure rates of 1.7 % and 1.2 % , respectively .


Fracture of restoration was the main reason for failure .


After 3 years , no significant difference was seen in overall clinical effectiveness between the silorane - based and methacrylate-based composite restorative systems .


Prosthetic reconstruction of the breast , as a 2-staged procedure using tissue expanders followed by placement of permanent implants , offers favorable aesthetic results with minimal additional surgical intervention .


However , the current outpatient process to fill saline expanders can be lengthy and onerous , involving months of office visits and discomfort from the bolus saline expansions .


We present a new technology ( AeroForm Tissue Expansion System ) , which has the potential to improve the process of breast tissue expansion by providing a method for low-volume incremental filling , eliminating the need for injections and directly involving the patient by allowing her some control over the expansion process .


The described study is a 2:1 randomized controlled trial of the investigational CO2 expansion system and saline expanders .


Of the 82 women receiving expanders , 58 ( 39 bilateral and 19 unilateral ; bilateral rate , 67 % ) were implanted with CO2 tissue expanders and 24 subjects ( 15 bilateral and 9 unilateral ; bilateral rate , 63 % ) were implanted with saline expanders .


Preliminary validated expansion results were available for 55 women .


Available mean time for active expansion in the CO2 group was 18.2 ( 9.2 ) days ( median , 14.0 ; range , 5-39 ; number of expanders , 53 ) , which was less than the mean time for active expansion in the saline group : 57.4 ( 33.6 ) days ( median , 55 ; range , 5-137 ; number of expanders , 33 ) .


Available mean time from implant placement to exchange for a permanent prosthesis in the CO2 group was shorter [ 106.3 ( 42.9 ) days ; median , 99 ; range , 42-237 ; number of expanders , 53 ] than for the women in the control group [ 151.7 ( 62.6 ) days ; median , 140 ; range , 69-433 ; number of expanders , 33 ] .


After 2 events -- underexpansion ( n = 1 ) and erosion ( n = 1 ) -- in the CO2 group , the internal membrane was redesigned and the expander bulk was decreased to minimize the risk of underexpansion and erosion in subsequent patients .


Preliminary evidence indicates that the CO2-based tissue expansion system performs the same function as saline expansion devices without significantly altering the risk to the patient and that the device has the potential to make the expansion process faster and more convenient for both the patient and the physician .


Cognitive bias modification ( CBM ) interventions have demonstrated efficacy in augmenting core biases implicated in psychopathology .


The current randomized controlled trial ( RCT ) will evaluate the efficacy of an internet-delivered positive imagery cognitive bias modification intervention for obsessive compulsive disorder ( OCD ) when compared to a control condition .


Patients meeting diagnostic criteria for a current or lifetime diagnosis of OCD will be recruited via the research arm of a not-for-profit clinical and research unit in Australia .


The minimum sample size for each group ( alpha set at 0.05 , power at .80 ) was identified as 29 , but increased to 35 to allow for 20 % attrition .


We will measure the impact of CBM on interpretations bias using the OC Bias Measure ( The Ambiguous Scenarios Test for OCD ; AST-OCD ) and OC-beliefs ( The Obsessive Beliefs Questionnaire-TRIP ; OBQ-TRIP ) .


Secondary outcome measures include the Dimensional Obsessive-Compulsive Scale ( DOCS ) , the Patient Health Questionnaire ( PHQ-9 ) , The Kessler Psychological Distress Scale ( K10 ) , and the Word Sentence Association Test for OCD ( WSAO ) .


Change in diagnostic status will be indexed using the OCD Mini International Neuropsychiatric Interview ( M.I.N.I ) Module at baseline and follow-up .


Intent-to-treat ( ITT ) marginal and mixed-effect models using restricted maximum likelihood ( REML ) estimation will be used to evaluate the primary hypotheses .


Stability of bias change will be assessed at 1-month follow-up .


A limitation of the online nature of the study is the inability to include a behavioral outcome measure .


The trial was registered on 10 October 2013 with the Australian New Zealand Clinical Trials Registry ( ACTRN12613001130752 ) .


Perennial allergic rhinitis ( PAR ) has a high and increasing prevalence worldwide .


Ear acupressure ( EAP ) is a noninvasive semi-self-administered form of acupuncture .


Previous studies indicated that EAP could be effective and safe for AR symptom management .


However , there was insufficient evidence to confirm this .


This study investigated whether EAP , a noninvasive clinical alternative to acupuncture , is effective and safe for PAR .


This is an international , multicenter , randomized , single-blind , sham-controlled trial .


The trial was conducted at two centers : Royal Melbourne Institute of Technology University ( Melbourne , Australia ) Clinical Trial Clinic and Guangdong Provincial Hospital of Chinese Medicine , Guangzhou , China .


PAR participants were randomized to receive real or sham EAP treatment once a week for 8 weeks and then were followed-up for 12 weeks .


Participants were instructed to administer EAP stimulation three times daily .


Symptom severity and quality of life ( QoL ) were evaluated .


Adverse events ( AEs ) were also monitored .


Intention-to-treat analysis on change of symptom scores and QoL was applied .


Two hundred forty-five participants were randomly assigned to real ( n = 124 ) and sham EAP ( n = 121 ) groups .


Twenty-five participants discontinued during treatment and 15 participants dropped out during follow-up .


At the end of treatment and follow-up periods , changes of global QoL score were significantly greater in the real EAP group compared with the sham group .


At the end of follow-up , scores for total nasal symptom , runny nose , and eye symptoms in the real EAP group had a greater reduction compared with the sham group .


Overall , both real and sham EAP were well tolerated .


Two severe AEs were reported but were not considered related to the EAP procedures .


In conclusion , EAP showed short-term and extended benefit for improving PAR symptoms and QoL for PAR patients .


Few studies to date have directly compared outcomes of retropubic ( RRP ) and laparoscopic ( LRP ) radical prostatectomy .


We investigated a single institution experience with RRP and LRP with respect to functional and pathological outcomes .


168 patients who underwent RRP were compared to 171 patients who underwent LRP at our institution .


Pathological and functional outcomes including postoperative urinary incontinence and erectile dysfunction ( ED ) of the two cohorts were examined .


Patients had bilateral , unilateral and no nerve sparing technique performed in 83.3 % , 1.8 % and 14.9 % of cases for RRP and 23.4 % , 22.8 % and 53.8 % of cases for LRP , respectively ( p < 0.001 ) .


Overall positive surgical margin rates were 22.2 % among patients who underwent RRP compared to 26.5 % of patients who underwent LRP ( p = 0.435 ) .


Based upon pads/day , urinary continence postoperatively was achieved in 83.2 % and 82.8 % for RRP and LRP , respectively ( p = 0.872 ) .


Analysis on postoperative ED was limited due to lack of information on the preoperative erectile status .


However , postoperatively there were no differences with respect to ED between the two cohorts ( p = 0.151 ) .


Based on ICIQ-scores , surgeons with more experience had lower rates of postoperative incontinence irrespective of surgical technique ( p = 0.001 and p < 0.001 for continuous and stratified data , respectively ) .


RRP and LRP represent effective surgical approaches for the treatment of clinically localized prostate cancer .


Pathological outcomes are excellent for both surgical techniques .


Functional outcomes including postoperative urinary incontinence and ED are comparable between the cohorts .


Surgeon experience is more relevant than surgical technique applied .


Up to 87 % of professional musicians develop work-related complaints of the musculoskeletal system during their careers .


Music school students are at specific risk for developing musculoskeletal complaints and disabilities .


This study aims to evaluate the effectiveness of a biopsychosocial prevention program to prevent or reduce disabilities from playing-related musculoskeletal disorders .


Secondary objectives are evaluation of cost-effectiveness and feasibility .


Healthy , first or second year students ( n = 150 ) will be asked to participate in a multicentre , single-blinded , parallel-group randomised controlled trial .


Students randomised to the intervention group ( n = 75 ) will participate in a biopsychosocial prevention program that addresses playing-related health problems and provides postural training according to the Mensendieck or Cesar methods of postural exercise therapy , while incorporating aspects from behavioural change theories .


A control group ( n = 75 ) will participate in a program that stimulates a healthy physical activity level using a pedometer , which conforms to international recommendations .


No long-term effects are expected from this control intervention .


Total follow-up duration is two years .


The primary outcome measure is disability ( Disabilities of Arm , Shoulder and Hand questionnaire ) .


The secondary outcome measures are pain , quality of life and changes in health behaviour .


Multilevel mixed-effect logistic or linear regression analyses will be performed to analyse the effects of the program on the aforementioned outcome measurements .


Furthermore , cost-effectiveness , cost-utility and feasibility will be analysed .


It is believed that this is the first comprehensive randomised controlled trial on the effect and rationale of a biopsychosocial prevention program for music students .


A post-approval ( PA ) study for destination therapy ( DT ) was required by the Food and Drug Administration ( FDA ) to determine whether results with the HeartMate ( HM ) II ( Thoratec , Pleasanton , California ) left ventricular assist device ( LVAD ) in a commercial setting were comparable to results during the DT multicenter pivotal clinical trial .


New device technology developed in the clinical research setting requires validation in a real-world setting .


The PA study was a prospective evaluation of the first 247 HM II patients identified pre-operatively as eligible for DT in the national INTERMACS ( Interagency Registry for Mechanically Assisted Circulatory Support ) registry .


Patients were enrolled from January to September 2010 at 61 U.S. centers and followed for 2 years .


A historical comparison group included patients ( n = 133 at 34 centers ) enrolled in the primary data cohort in the DT pivotal trial ( TR ) .


Survival rates and adverse events for the PA group were obtained from the INTERMACS registry .


Baseline characteristics were similar for PA versus TR .


Forty-five percent of PA patients were in INTERMACS profiles 1 to 2 and 28 % were in profile 3 .


Adverse events in the PA group were similar or lower than those in the TR group , including improvements in device-related infection ( 0.22 vs. 0.47 ) and post-operative bleeding requiring surgery ( 0.09 vs. 0.23 ) events per patient-year .


Kaplan-Meier survival at 2 years was 62 % ( PA group ) versus 58 % ( TR group ) .


PA group survival at 1 and 2 years was 82 5 % and 69 6 % for INTERMACS profiles 4 to 7 ( n = 63 ) versus 72 3 % and 60 4 % for profiles 1 to 3 ( n = 184 ) .


The median length of stay after surgery was reduced by 6 days in the PA group versus the TR group .


Results in a commercial patient care setting for the DT population supported the original pivotal clinical trial findings regarding the efficacy and risk profile of the HM II LVAD .


Survival was best in patients who were not inotrope-dependent ( INTERMACS profiles 4 to 7 ) .


To investigate how group-based exercise affects the levels of physical activity , physical fitness and health - related quality of life ( HRQoL ) in patients with chronic heart failure and comorbidities .


Randomized controlled trial .


A total of 48 patients ( 10 women , 38 men ) , mean age 71 years ( standard deviation 8 years ) , ejection fraction 27 % ( standard deviation 10 % ) , and New York Heart Association functional class II-III .


A bicycle test , 6-min walk test ( 6MWT ) and muscle endurance tests were performed .


Physical activity was assessed with a pedometer and the International Physical Activity Questionnaire ( IPAQ ) , HRQoL was evaluated with the Short Form-36 ( SF-36 ) .


Patients were randomized to control or intervention groups .


Intervention consisted of an individually designed group-based exercise programme twice a week , for a period of 3 months .


Subjects in the control group were asked to continue with their usual lives .


A total of 42 patients completed the study , and 6 dropped-out .


Steps/day did not increase significantly after intervention ( p = 0.351 ) , but IPAQ score did ( p = 0.008 ) .


Exercise tolerance ( p = 0.001 ) , 6MWT ( p = 0.014 ) , shoulder abduction ( p = 0.028 ) , heel lift ( p < 0.0001 ) and HRQoL ( p = 0.018 ) improved significantly in the intervention group compared with the control group .


Group-based exercise did not improve the level of physical activity in patients with chronic heart failure and comorbidity ; however , physical fitness and HRQoL were significantly improved .


Phase 1 evaluation of the VRC HIV DNA and rAd5 vaccines delivered intramuscularly ( i.m. ) supported proceeding to a Phase 2 b efficacy study .


Here we report comparison of the i.m. , subcutaneous ( s.c. ) and intradermal ( i.d. ) routes of administration .


Sixty subjects were randomized to 6 schedules to evaluate the i.m. , s.c. or i.d. route for prime injections .


Three schedules included DNA primes ( Wks 0,4,8 ) and 3 schedules included rAd5 prime ( Wk0 ) ; all included rAd5 i.m. boost ( Wk24 ) .


DNA vaccine dosage was 4 mg i.m. or s.c. , but 0.4 mg i.d. , while all rAd5 vaccinations were 1010 PU .


All injections were administered by needle and syringe .


Overall , 27/30 subjects completed 3 DNA primes ; 30/30 subjects completed rAd5 primes .


Mild local pruritus ( itchiness ) , superficial skin lesions and injection site nodules were associated with i.d. and s.c. , but not i.m. injections .


All routes induced T-cell and antibody immune responses after rAd5 boosting .


Overall , > 95 % had Env antibody and > 80 % had Env T-cell responses .


The pattern of local reactogenicity following i.d. and s.c. injections differed from i.m. injections but all routes were well-tolerated .


There was no evidence of an immunogenicity advantage following s.c. or i.d. delivery , supporting i.m. delivery as the preferred route of administration .


Clinicaltrials.gov NCT00321061 .


Existing studies of mental health interventions in low-resource settings have employed highly structured interventions delivered by non-professionals that typically do not vary by client .


Given high comorbidity among mental health problems and implementation challenges with scaling up multiple structured evidence-based treatments ( EBTs ) , a transdiagnostic treatment could provide an additional option for approaching community-based treatment of mental health problems .


Our objective was to test such an approach specifically designed for flexible treatments of varying and comorbid disorders among trauma survivors in a low-resource setting .


We conducted a single-blinded , wait-list randomized controlled trial of a newly developed transdiagnostic psychotherapy , Common Elements Treatment Approach ( CETA ) , for low-resource settings , compared with wait-list control ( WLC ) .


CETA was delivered by lay workers to Burmese survivors of imprisonment , torture , and related traumas , with flexibility based on client presentation .


Eligible participants reported trauma exposure and met severity criteria for depression and/or posttraumatic stress ( PTS ) .


Participants were randomly assigned to CETA ( n = 182 ) or WLC ( n = 165 ) .


Outcomes were assessed by interviewers blinded to participant allocation using locally adapted standard measures of depression and PTS ( primary outcomes ) and functional impairment , anxiety symptoms , aggression , and alcohol use ( secondary outcomes ) .


Primary analysis was intent-to-treat ( n = 347 ) , including 73 participants lost to follow-up .


CETA participants experienced significantly greater reductions of baseline symptoms across all outcomes with the exception of alcohol use ( alcohol use analysis was confined to problem drinkers ) .


The difference in mean change from pre-intervention to post-intervention between intervention and control groups was -0.49 ( 95 % CI : -0.59 , -0.40 ) for depression , -0.43 ( 95 % CI : -0.51 , -0.35 ) for PTS , -0.42 ( 95 % CI : -0.58 , -0.27 ) for functional impairment , -0.48 ( 95 % CI : -0.61 , -0.34 ) for anxiety , -0.24 ( 95 % CI : -0.34 , -0.15 ) for aggression , and -0.03 ( 95 % CI : -0.44 , 0.50 ) for alcohol use .


This corresponds to a 77 % reduction in mean baseline depression score among CETA participants compared to a 40 % reduction among controls , with respective values for the other outcomes of 76 % and 41 % for anxiety , 75 % and 37 % for PTS , 67 % and 22 % for functional impairment , and 71 % and 32 % for aggression .


Effect sizes ( Cohen 's d ) were large for depression ( d = 1.16 ) and PTS ( d = 1.19 ) ; moderate for impaired function ( d = 0.63 ) , anxiety ( d = 0.79 ) , and aggression ( d = 0.58 ) ; and none for alcohol use .


There were no adverse events .


Limitations of the study include the lack of long-term follow-up , non-blinding of service providers and participants , and no placebo or active comparison intervention .


CETA provided by lay counselors was highly effective across disorders among trauma survivors compared to WLCs .


These results support the further development and testing of transdiagnostic approaches as possible treatment options alongside existing EBTs .


ClinicalTrials.gov NCT01459068 Please see later in the article for the Editors ' Summary .


The wide use of computed tomography ( CT ) for diverticulitis has initiated new classifications , but their reliability has not been studied .


The aim of the study was to assess the inter-observer agreement of radiologists on the classifications of diverticulitis .


A set of 100 CT examinations of patients with an episode of diverticulitis was used to assess inter-observer agreement .


Cases were derived from two prospective trials and a retrospective cohort to comprise an evenly distributed case mix of patients .


The reference standard was the modified Hinchey classification based on all available information .


Three blinded radiologists independently read all CT examinations .


We calculated the proportion of agreement and kappa values for the Hinchey and Ambrosetti classifications .


For the Dharmarajan classification only inter-observer agreement was calculated .


The agreement with the reference standard was substantial for both the modified Hinchey and the Ambrosetti classifications ( P = 0.68 and P = 0.76 ) .


Overall inter-observer agreement for the modified Hinchey classification was substantial ( median kappa 0.72 ) , for the Ambrosetti classification almost perfect ( median kappa 0.83 ) and for the Dharmarajan classification substantial ( median kappa 0.76 ) .


The Ambrosetti classification is more reproducible than the modified Hinchey and Dharmarajan classifications .


The Ambrosetti and modified Hinchey classifications have a substantial agreement with the reference standard and therefore produce a reliable classification .


The Dhamarajan is applicable only in complicated diverticulitis and is an important complementary classification to the other more general classifications of diverticulitis .


Exercise is beneficial to learning .


The purpose of this research was to determine whether an episode of aerobic exercise prior to practice improves the acquisition and retention of laparoscopic skills in the fundamentals of laparoscopic surgery ( FLS ) simulator .


Baseline maximal physical fitness ( VO2 max ) , performance on peg transfer ( PT ) , pattern cut ( PC ) , and intracorporeal suture ( ICS ) were measured for FLS nave undergraduates .


2 Weeks later , participants were randomized into exercise ( E ) and control ( C ) groups .


C did unrelated work for 40 min and then practiced PT and PC for 10 min , and ICS for 15 min .


Final scores were recorded .


In E , participants ran on a treadmill for 20 min at 60 % of their VO2 max .


After a 15 min cool down , they engaged in identical FLS simulator training as group C. Both groups completed the NASA task load index ( TLX ) to assess workload .


Retention was recorded 2 months after the training session .


Groups were compared using t tests , ( 2 ) and Wilcoxon rank tests .


p < 0.05 was considered significant .


There were 52 participants ( 22 in C ; 30 in E ) with high physical fitness at baseline .


Demographics between the groups were similar at baseline .


There were no differences in VO2 max and scores on the three tasks at baseline ( all p values NS ) .


There was no statistical significance between the scores of the C and E groups at the training session and retention , except for higher PT scores in the E group after the training session .


In physically fit , surgically nave students , one bout of aerobic exercise enhanced immediate learning of simple FLS skills but did not have an impact on more complex skills or on retention .


The use of exercise in the surgical curriculum , or as a learning tool , warrants further investigation regarding how best to apply it .


No studies have compared robot-assisted transaxillary thyroidectomy ( RATT ) and minimally invasive video-assisted thyroidectomy ( MIVAT ) regarding cosmetic outcome and satisfaction


Patients matching the inclusion criteria ( benign nodule less than 4 cm and thyroid volume less than 30 mL ) were randomly allotted to undergo MIVAT ( group A ) or RATT ( group B ) .


Cosmetic result , overall satisfaction , operative time , and complications were evaluated .


A total of 62 patients underwent hemithyroidectomy ( 30 in group A and 32 in group B ) .


All patients were women , with the exception of one man in each group .


The mean patient age was 36.9 years ( group A ) and 32.5 years ( group B ) .


Total operative time ( intubation-extubation ) was shorter in group A ( 71.6 min ) than in group B ( 120.4 min ) .


Complications included one transient laryngeal nerve injury in each group and one subcutaneous hematoma in group B. Postoperative hospital stay was longer in group B ( 1.85 days ) than in group A ( 1.15 days ) .


On the PASQ questionnaire , `` scar appearance '' and `` satisfaction with appearance '' scores were better in group A than in group B.


In the Short Form ( SF-36 ) 36-Item Health Survey Questionnaire , domains of `` social activity '' and `` general health '' were better in group B than in group A , whereas `` bodily pain '' scored higher in group B than in group A.


RATT seems not to supersede MIVAT in terms of satisfaction when comparing two groups of patients undergoing thyroidectomy for benign disease .


Osteoporosis is a growing problem facing modern society and currently poses one of the most serious health challenges .


It is a progressive skeletal disease characterised by low bone mineral density whose development depends on multiple factors .


These principally include increasing age , nutrition , physical activity , endocrine changes , lifestyles , general health condition and taken drugs .


To assess how much subjects ( aged > 50 years ) are aware of the dangers in contracting osteoporosis along with the effects that lifestyle and dairy product consumption can have on this condition developing .


A questionnaire , designed in-house , was used to survey a group of 150 randomly selected individuals aged above 50 years .


This was performed in June 2012 .


Questions were on socio-demographics , milk and dairy product consumption , physical activity as well as assessing knowledge about osteoporosis that included issues such as its incidence , prevention and morbidity .


Osteoporosis was established in 60.7 % subjects of whom 69.2 % were women .


Only 9.3 % never consumed any dairy products .


Physical activity of some kind was undertaken by 77.3 % subjects .


Within the last year , 38.0 % reported having fractures of whom 46.0 % had osteoporosis and 25 % were healthy .


Respondents were aware that consuming dairy products is beneficial to bone health and this awareness was higher among those with osteoporosis .


Physical activity was also recognised to be important in preventing this condition .


Subjects suffering from osteoporosis had twice as many more fractures than healthy subjects .


Younger patients with unicompartmental degenerative knee joint diseases present a therapeutic dilemma .


The purpose of this study is to evaluate the long-term results of the Oxford phase III unicompartmental knee replacement through a minimally invasive approach in the young patient .


We have studied a total of 51 patients ( 59 interventions ) who underwent the Oxford Phase III Unicompartmental Knee Replacement .


A clinical , radiographical and functional evaluation was performed twelve years after intervention .


According to the American Knee Society Score using Insall 's criteria overall results of unicompartmental knee arthroplasty showed an excellent or good outcome for 53 knees ( 96.36 % ) , fair for 1 ( 1.81 % ) and poor for 1 ( 1.81 % ) in the postoperative long term .


The survival rate of the implants was close to 95 % at follow-up .


Twelve years follow-up results of UKA through a minimally invasive exposure in young patients demonstrate predictably good outcomes .


The HealthValues Healthy Eating Programme is a standalone Internet-based intervention that employs a novel strategy for promoting behavior change ( analyzing one 's reasons for endorsing health values ) alongside other psychological principles that have been shown to influence behavior .


The program consists of phases targeting motivation ( dietary feedback and advice , analyzing reasons for health values , thinking about health-related desires , and concerns ) , volition ( implementation intentions with mental contrasting ) , and maintenance ( reviewing tasks , weekly tips ) .


The aim was to examine the effects of the program on consumption of fruit and vegetables , saturated fat , and added sugar over a 6-month period .


A total of 82 females and 18 males were recruited using both online and print advertisements in the local community .


They were allocated to an intervention or control group using a stratified block randomization protocol .


The program was designed such that participants logged onto a website every week for 24 weeks and completed health-related measures .


Those allocated to the intervention group also completed the intervention tasks at these sessions .


Additionally , all participants attended laboratory sessions at baseline , 3 months , and 6 months .


During these sessions , participants completed a food frequency questionnaire ( FFQ , the Block Fat/Sugar/Fruit / Vegetable Screener , adapted for the UK ) , and researchers ( blind to group allocation ) measured their body mass index ( BMI ) , waist-to-hip ratio ( WHR ) , and heart rate variability ( HRV ) .


Data were analyzed using a series of ANOVA models .


Per protocol analysis ( n = 92 ) showed a significant interaction for fruit and vegetable consumption ( P = .048 ) ; the intervention group increased their intake between baseline and 6 months ( 3.7 to 4.1 cups ) relative to the control group ( 3.6 to 3.4 cups ) .


Results also showed overall reductions in saturated fat intake ( 20.2 to 15.6 g , P < .001 ) and added sugar intake ( 44.6 to 33.9 g , P < .001 ) during this period , but there were no interactions with group .


Similarly , there were overall reductions in BMI ( 27.7 to 27.3 kg/m ( 2 ) , P = .001 ) and WHR ( 0.82 to 0.81 , P = .009 ) , but no interactions with group .


The intervention did not affect alcohol consumption , physical activity , smoking , or HRV .


Data collected during the online sessions suggested that the changes in fruit and vegetable consumption were driven by the motivational and maintenance phases of the program .


Results suggest that the program helped individuals to increase their consumption of fruit and vegetables and to sustain this over a 6-month period .


The observed reduction in fat and sugar intake suggests that monitoring behaviors over time is effective , although further research is needed to confirm this conclusion .


The Web-based nature of the program makes it a potentially cost-effective way of promoting healthy eating .


Laparoscopic cholecystectomy ( LC ) is increasingly being performed as a day-care surgery .


Intraperitoneal ( IP ) instillation of lignocaine has been proved to provide pain relief following LC .


Of late , there is an increased interest in using intravenous ( IV ) lignocaine to provide pain relief following LC .


There are no studies in the existing literature as to which form of administration is more effective for pain relief .


Hence , this study has been undertaken .


Patients ( n = 50 ) undergoing LC for symptomatic cholelithiasis were randomized into two groups ( n = 25 each ) to receive IV 2 % lignocaine from induction until 1 h after surgery or IP instillation of 0.2 % lignocaine in the gallbladder fossa after removal of gallbladder .


Postoperative analgesic requirement , pain scores , time to return of bowel activity , and stress response were assessed .


The mean total morphine requirement ( p = 0.001 ) , median VAS , first analgesic requirement time ( p < 0.001 ) , and total PCA demands ( p < 0.001 ) during the 24-h period were statistically significantly less in the IV group compared with the IP group .


Return of bowel activity was earlier in the IV group , and it was statistically significant ( p < 0.001 ) .


However , stress response , respiratory function , and postoperative nausea and vomiting were not significant statistically among the two groups .


IV lignocaine is superior to IP lignocaine in providing pain relief following LC .


IV lignocaine has an added advantage of bringing about the early return of bowel activity , which will further facilitate surgeons to perform LC as a day-care procedure .


Evaluation of microbiological effectiveness of longidaze preparation use during therapy of active non-specific endometritis in women with uterus myoma .


2 groups of women were formed by a method of random selection .


The first was composed of patients with active chronic endometritis , that had received standard etiotropic antibacterial therapy .


The second included patients , that had received longidaze in addition to the standard therapy .


Therapy effectiveness evaluation was carried out based on the analysis of microbial landscape of cervical canal and uterine cavity 2 months after the therapy during phase I of the menstrual cycle .


Non-plasma-coagulating staphylococci , enterococci and anaerobes were established to be present predominately in the examined women of both the first and the second group .


The application of longidaze in combination with antibacterial therapy results in the most significant improvement of microbial landscape of cervical canal and uterine cavity .


Overexpression of COX-2 correlates with advanced stage and worse outcomes in non-small-cell lung cancer ( NSCLC ) , possibly as a result of elevated levels of COX-2-dependent prostaglandin E2 ( PGE2 ) .


Exploratory analyses of studies that used COX-2 inhibitors have demonstrated potentially superior outcome in patients in whom the urinary metabolite of PGE2 ( PGE-M ) is suppressed .


We hypothesized that patients with disease defined by PGE-M suppression would benefit from the addition of apricoxib to second-line docetaxel or pemetrexed .


Patients with NSCLC who had disease progression after one line of platinum-based therapy , performance status of 0 to 2 , and normal organ function were potentially eligible .


Only patients with a 50 % decrease in urinary PGE-M after 5 days of treatment with apricoxib could enroll .


Docetaxel 75 mg/m ( 2 ) or pemetrexed 500 mg/m ( 2 ) once every 21 days per the investigator was administered with apricoxib or placebo 400 mg once per day .


The primary end point was progression-free survival ( PFS ) .


Exploratory analysis was performed regarding baseline urinary PGE-M and outcomes .


In all , 101 patients completed screening , and 72 of the 80 who demonstrated 50 % suppression were randomly assigned to apricoxib or placebo .


Toxicity was similar between the arms .


No improvement in PFS was seen with apricoxib versus placebo .


The median PFS for the control arm was 97 days ( 95 % CI , 52 to 193 days ) versus 85 days ( 95 % CI , 67 to 142 days ) for the experimental arm ( P = .91 ) .


Apricoxib did not improve PFS , despite biomarker-driven patient selection .


To determine the efficacy and safety benefits of performing intraoperative cholangiography ( IOC ) during laparoscopic cholecystectomy ( LC ) to treat symptomatic cholelithiasis .


Patients admitted to the Minimally Invasive Surgery Center of Tianjin Nankai Hospital between January 2012 and January 2014 for management of symptomatic cholelithiasis were recruited for this prospective randomized trial .


Study enrollment was offered to patients with clinical presentation of biliary colic symptoms , radiological findings suggestive of gallstones , and normal serum biochemistry results .


Study participants were randomized to receive either routine LC treatment or LC+IOC treatment .


The routine LC procedure was carried out using the standard four-port technique ; the LC+IOC procedure was carried out with the addition of meglumine diatrizoate ( 1:1 dilution with normal saline ) injection via a catheter introduced through a small incision in the cystic duct made by laparoscopic scissors .


Operative data and postoperative outcomes , including operative time , retained common bile duct ( CBD ) stones , CBD injury , other complications and length of hospital stay , were recorded for comparative analysis .


Inter-group differences were statistically assessed by the 2 test ( categorical variables ) and Fisher 's exact test ( binary variables ) , with the threshold for statistical significance set at P < 0.05 .


A total of 371 patients were enrolled in the trial ( late-adolescent to adult , age range : 16-70 years ) , with 185 assigned to the routine LC group and 186 to the LC+IOC group .


The two treatment groups were similar in age , sex , body mass index , duration of symptomology , number and size of gallstones , and clinical symptoms .


The two treatment groups also showed no significant differences in the rates of successful LC ( 98.38 % vs 97.85 % ) , CBD stone retainment ( 0.54 % vs 0.00 % ) , CBD injury ( 0.54 % vs 0.53 % ) and other complications ( 2.16 % vs 2.15 % ) , as well as in duration of hospital stay ( 5.101.41 d vs 4.991.53 d ) .


However , the LC+IOC treatment group showed significantly longer mean operative time ( routine LC group : 43.004.15 min vs 52.864.47 min , P < 0.01 ) .


There were no cases of fatal complications in either group .


At the one-year follow-up assessment , one patient in the routine LC group reported experiencing diarrhea for three months after the LC and one patient in the LC+IOC group reported on-going intermittent epigastric discomfort , but radiological examination provided no abnormal findings .


IOC addition to the routine LC treatment of symptomatic cholelithiasis does not improve rates of CBD stone retainment or bile duct injury but lengthens operative time .


The purpose of this study was to assess the effectiveness of global postural reeducation ( GPR ) relative to segmental exercises ( SE ) in the treatment of scapular dyskinesis ( SD ) associated with neck pain .


Participants with SD and neck pain ( n = 30 ) aged 18 to 65 years were randomly assigned to one of two groups : GPR and SE ( stretching exercises ) .


The upper extremity was assessed using the Disabilities of the Arm , Shoulder , and Hand questionnaire ; function of the neck was estimated using the Neck Disability Index ; pain severity was measured using a visual analogical scale ; and health-related quality of life was assessed using the Short Form-12 .


Assessments were conducted at baseline and after 10 weekly sessions ( 60 minutes each ) .


The significance level adopted was < .05 .


For pre-post treatment comparisons , GPR was significantly associated with improvements in function of neck and upper extremities , pain , and physical and mental domains of quality of life ( P < .05 ) .


Segmental exercises improved function of upper extremities and of the neck and severity of pain ( P < .05 ) .


When contrasting groups , GPR was significantly superior to SE in improving pain and physical domains of the quality of life .


This study showed that GPR and SE had similar effects on function of the neck and upper extremity in patients with SD associated with neck pain .


When comparing groups , GPR was superior to SE in improving pain and quality of life .


It is widely believed that in patients with allergic rhinitis and asthma , avoidance of specific triggers can help improve symptom control and reduce need for medication .


Whilst most patients with asthma or rhinitis are sensitized to airborne allergens , primary care diagnostic and management decisions are often made without either obtaining a detailed history of the patient 's allergic triggers or performing skin prick tests .


Thus , management decisions are empirical and allergen avoidance advice is either not given or , if given , not tailored to the patient 's sensitivities .


To ascertain whether allergy assessment and tailored advice in general practice for patients with asthma and rhinitis enhance well-being , we conducted a pragmatic , open , randomized controlled trial of allergy intervention ( structured allergy history and skin prick testing and appropriate advice on allergy avoidance ) versus usual care in adult patients with a working diagnosis of asthma and/or rhino-conjunctivitis .


Outcomes were assessed after 12months by an observer who was blinded to allocation .


The main outcome measures were asthma and rhinitis symptoms , disease-specific health-related quality of life , generic quality of life and lung function .


There were no significant differences in baseline demographics or disease characteristics between patients assigned to immediate or delayed skin prick testing .


No significant differences were observed between groups for any measures of symptoms , quality of life or lung function at 12months ( all P > 0.05 ) .


Amongst adults with known asthma and/or rhinitis in primary care , taking a structured allergy history with skin prick tests and giving tailored advice on allergy avoidance made no difference to their symptoms , quality of life or lung function as measured twelve months later .


The purpose of this study was to evaluate the clinical performance of posterior preveneered stainless steel crowns after three years .


NuSmile crowns and Kinder Krowns were randomly allocated on paired molars using a split-mouth design .


Variables such as fracture , wear , gingival health , and esthetics were recorded .


( P < .05 ) .


Statistical analysis was completed on 34 paired crowns in 14 children .


After three years , 53 percent of crowns were fracture free compared to 81 percent at one year .


There was minimal esthetic impact for most fractures due to the location of the veneer fracture , but five crowns had extensive fracture .


No difference was reported in the clinical performance between the two crown types .


Fracture was more likely to occur where the adjacent tooth was missing .


Parents reported a satisfaction rating of 8.3 out of 10 .


Clinical performance of both crown types was similar and successful for three years .


Facing fracture occurred in 47 percent of crowns but had minimal impact on the esthetic value or parental satisfaction in the majority of cases .


These crowns offer an esthetic alternative to the traditional stainless steel crown , but parents should be alerted to the possibility of veneer loss over time .


Treatment options for recurrent glioblastoma are scarce , with second-line chemotherapy showing only modest activity against the tumour .


Despite the absence of well controlled trials , bevacizumab is widely used in the treatment of recurrent glioblastoma .


Nonetheless , whether the high response rates reported after treatment with this drug translate into an overall survival benefit remains unclear .


We report the results of the first randomised controlled phase 2 trial of bevacizumab in recurrent glioblastoma .


The BELOB trial was an open-label , three-group , multicentre phase 2 study undertaken in 14 hospitals in the Netherlands .


Adult patients ( 18 years of age ) with a first recurrence of a glioblastoma after temozolomide chemoradiotherapy were randomly allocated by a web-based program to treatment with oral lomustine 110 mg/m ( 2 ) once every 6 weeks , intravenous bevacizumab 10 mg/kg once every 2 weeks , or combination treatment with lomustine 110 mg/m ( 2 ) every 6 weeks and bevacizumab 10 mg/kg every 2 weeks .


Randomisation of patients was stratified with a minimisation procedure , in which the stratification factors were centre , Eastern Cooperative Oncology Group performance status , and age .


The primary outcome was overall survival at 9 months , analysed by intention to treat .


A safety analysis was planned after the first ten patients completed two cycles of 6 weeks in the combination treatment group .


This trial is registered with the Nederlands Trial Register ( www.trialregister.nl , number NTR1929 ) .


Between Dec 11 , 2009 , and Nov 10 , 2011 , 153 patients were enrolled .


The preplanned safety analysis was done after eight patients had been treated , because of haematological adverse events ( three patients had grade 3 thrombocytopenia and two had grade 4 thrombocytopenia ) which reduced bevacizumab dose intensity ; the lomustine dose in the combination treatment group was thereafter reduced to 90 mg/m ( 2 ) .


Thus , in addition to the eight patients who were randomly assigned to receive bevacizumab plus lomustine 110 mg/m ( 2 ) , 51 patients were assigned to receive bevacizumab alone , 47 to receive lomustine alone , and 47 to receive bevacizumab plus lomustine 90 mg/m ( 2 ) .


Of these patients , 50 in the bevacizumab alone group , 46 in the lomustine alone group , and 44 in the bevacizumab and lomustine 90 mg/m ( 2 ) group were eligible for analyses .


9-month overall survival was 43 % ( 95 % CI 29-57 ) in the lomustine group , 38 % ( 25-51 ) in the bevacizumab group , 59 % ( 43-72 ) in the bevacizumab and lomustine 90 mg/m ( 2 ) group , 87 % ( 39-98 ) in the bevacizumab and lomustine 110 mg/m ( 2 ) group , and 63 % ( 49-75 ) for the combined bevacizumab and lomustine groups .


After the reduction in lomustine dose in the combination group , the combined treatment was well tolerated .


The most frequent grade 3 or worse toxicities were hypertension ( 13 [ 26 % ] of 50 patients in the bevacizumab group , three [ 7 % ] of 46 in the lomustine group , and 11 [ 25 % ] of 44 in the bevacizumab and lomustine 90 mg/m ( 2 ) group ) , fatigue ( two [ 4 % ] , four [ 9 % ] , and eight [ 18 % ] ) , and infections ( three [ 6 % ] , two [ 4 % ] , and five [ 11 % ] ) .


At the time of this analysis , 144/148 ( 97 % ) of patients had died and three ( 2 % ) were still on treatment .


The combination of bevacizumab and lomustine met prespecified criteria for assessment of this treatment in further phase 3 studies .


However , the results in the bevacizumab alone group do not justify further studies of this treatment .


Roche Nederland and KWF Kankerbestrijding .


A study designed to examine the importance of the sensory attributes of oral nutritional supplements on preference and likelihood of compliance .


Independent individuals 50 years not currently receiving oral nutritional supplements were recruited to a two-stage , single-blind , randomised , preference study , conducted in four European countries .


Stage 1 consisted of a 5-day trial period during which two units of commonly prescribed oral nutritional supplements were administered , with a different oral nutritional supplements being consumed each day .


In Stage 2 , all participants consumed two units daily of one oral nutritional supplements for five days and two units daily of a second oral nutritional supplements for a further five days .


Using standardised hedonic scales , participants reported their perceptions of each oral nutritional supplements for a range of sensory attributes , and estimated how many units of each oral nutritional supplements they could consume .


One thousand seven hundred seventy one individuals completed the study .


The overall opinion of each oral nutritional supplements was strongly correlated with taste ( r = 0.91 ; p < 0,0001 ) , while unit volume demonstrated a weak relationship ( r = 0,29 ; p < 0,0001 ) .


One oral nutritional supplements ( Reformulated Ensure Plus ) was preferred overall , scoring significantly higher for taste ( p < 0,05 ) and oral sensation ( p < 0,05 ) than other oral nutritional supplements .


This study contributes to the understanding of how sensory attributes , particularly taste and oral sensation , influence preference and compliance to oral nutritional supplements .


We are aimed to investigate whether right ventricular mid-septal pacing ( RVMSP ) is superior to conventional right ventricular apical pacing ( RVAP ) in improving clinical functional capacity and left ventricular ejection fraction ( LVEF ) for patients with high-degree atrio-ventricular block and moderately depressed left ventricle ( LV ) function .


Ninety-two patients with high-degree atrio-ventricular block and moderately reduced LVEF ( ranging from 35 % to 50 % ) were randomly allocated to RVMSP ( n = 45 ) and RVAP ( n = 47 ) .


New York Heart Association ( NYHA ) functional class , echocardiographic LVEF , and distance during a 6-min walk test ( 6MWT ) were determined at 18 months after pacemaker implantation .


Serum levels of N-terminal pro-brain natriuretic peptide ( NT-proBNP ) were measured using an enzyme-linked immunosorbent assay ( ELISA ) kit .


Compared with baseline , NYHA functional class remained unchanged at 18 months , distance during 6MWT ( 485 m vs. 517 m ) and LVEF ( 36.7 % vs. 41.8 % ) were increased , but BNP levels were reduced ( 2352 pg/ml vs. 710 pg/ml ) in the RVMSP group compared with those in the RVAP group , especially in patients with LVEF 35 % -40 % ( for all comparisons , P < 0.05 ) .


However , clinical function capacity and LV function measurements were not significantly changed in patients with RVAP , despite the pacing measurements being similar in both groups , such as R-wave amplitude and capture threshold .


RVMSP provides a better clinical utility , compared with RVAP , in patients with high-degree atrioventricular block and moderately depressed LV function whose LVEF levels ranged from 35 % to 40 % .


To examine the effects of a supervised aerobic exercise programme on heart rate variability ( HRV ) parameters and symptom severity in women with fibromyalgia ( FM ) .


Thirty-two women with FM were randomly allocated to one of two groups : aerobic exercise ( AE ) or usual care control for 24 weeks .


Women allocated to AE performed two aerobic exercise sessions per week of 45-60 min duration including 15-20 min of steady-state aerobic exercise at 60-65 % of predicted maximum heart rate ( HRmax ) and 15 min of interval training at 75-80 % HRmax ( six repetitions of 1.5 min , with 1 min interpolated rest intervals ) .


Cardiac autonomic modulation was assessed using power spectral analysis of HRV .


Symptom severity was assessed by a 10 cm visual analogue scale ( VAS ) for pain , sleep disturbances , stiffness , anxiety and depression .


After 24 weeks , the women in the exercise group showed an increase ( 4.8 0.2 to 5.2 0.2 ) in total power ( LnTP , p < 0.001 ) , low frequency power ( LnLF , p < 0.01 ) , high frequency power ( LnHF , p < 0.001 ) , and the root-mean-square of successive R-R intervals ( rMSSD , p < 0.001 ) .


In addition , significant group-by-time interaction effects were observed for LnHF ( p = 0.036 ) and LnLF/HF ( p = 0.014 ) .


Improvements in anxiety and depression were also observed in AE versus control patients .


These results show that a programme of aerobic exercise training induced changes in cardiac autonomic nervous system modulation in FM and that these changes in HRV parameters were accompanied by changes in anxiety and depression .


This study investigated relevant pharmacodynamic and pharmacokinetic parameters during the transition from warfarin to rivaroxaban in healthy male subjects .


Ninety-six healthy men were randomized into the following three groups : warfarin [ international normalized ratio ( INR ) 2.0-3 .0 ] transitioned to rivaroxaban 20mg once daily ( od ; group A ) ; warfarin ( INR 2.0-3 .0 ) followed by placebo od ( group B ) ; and rivaroxaban alone 20mg od ( group C ) for 4 days .


Anti-factor Xa activity , inhibition of factor Xa activity , prothrombin time ( PT ) , activated partial thromboplastin time , HepTest , prothrombinase-induced clotting time , factor VIIa activity , factor IIa activity , endogenous thrombin potential and pharmacokinetics were measured .


An additive effect was observed on the PT and PT/INR during the initial transition period .


The mean maximal prolongation of PT was 4.39-fold [ coefficient of variation ( CV ) 18.03 % ; range 3.39-6 .50 ] of the baseline value in groupA , compared with 1.88-fold ( CV 10.35 % ; range 1.53-2 .21 ) in groupB and 1.57-fold ( CV 9.98 % ; range 1.37-2 .09 ) in groupC .


Rivaroxaban had minimal influence on the PT/INR at trough levels .


Inhibition of factor Xa activity , activated partial thromboplastin time and endogenous thrombin potential were also enhanced , but to a lesser extent .


In contrast , the effects of rivaroxaban on anti-factor Xa activity , HepTest and prothrombinase-induced clotting time were not affected by pretreatment with warfarin .


Changes in pharmacodynamics during the transition from warfarin to rivaroxaban vary depending on the test used .


A supra-additive effect on PT/INR is expected during the initial period of transition , but pretreatment with warfarin does not influence the effect of rivaroxaban on anti-factor Xa activity .


Hope is an essential dimension of successful coping in the context of illnesses such as HIV/AIDS , because positive expectations for the future alleviate emotional distress , enhance quality of life and have been linked to the capacity for behavioural change .


The social environment ( e.g. family , peers ) is a regulator of hope for people living with HIV/AIDS ( PLWHA ) .


In this regard , the dual aim of this article is ( 1 ) to analyze the influence of a peer adherence support ( PAS ) intervention and the family environment on the state of hope in PLWHA and ( 2 ) to investigate the interrelationship between the two determinants .


The Effective AIDS Treatment and Support in the Free State study is a prospective randomized controlled trial .


Participants were recruited from 12 public antiretroviral treatment ( ART ) clinics across five districts in the Free State Province of South Africa .


Each of these patients was assigned to one of the following groups : a control group receiving standard care , a group receiving additional biweekly PAS or a group receiving PAS and nutritional support .


Latent cross-lagged modelling ( Mplus ) was used to analyse the impact of PAS and the family environment on the level of hope in PLWHA .


The results of the study indicate that neither PAS nor the family environment has a direct effect on the level of hope in PLWHA .


Subsequent analysis reveals a positive significant interaction between family functioning and PAS at the second follow-up , indicating that better family functioning increases the positive effect of PAS on the state of hope in PLWHA .


The interplay between well-functioning families and external PAS generates higher levels of hope , which is an essential dimension in the success of lifelong treatment .


This study provides additional insight into the important role played by family dynamics in HIV/AIDS care , and it underscores the need for PAS interventions that are sensitive to the contexts in which they are implemented .


To assess how acute consumption of fructose affects flow-mediated dilatation in brachial artery .


The randomised cross-over study was conducted at the University of Nottingham 's Medical School , Nottingham , United Kingdom in July 2009 .


Ten healthy , white European males visited the laboratory twice , on separate mornings .


On each visit , the volunteers consumed water ( 3 ml/kg bodyweight ) and rested semi-supine on the bed .


After 30 minutes , baseline diastolic brachial artery diameter and blood velocity was measured .


At 60 minutes , blood velocity and five scans of brachial artery diameter were recorded before a blood pressure cuff was inflated on the forearm for 5 minutes and at 50-60-70-80 and 90 sec after cuff deflation .


Fifteen minutes later , the volunteers consumed 500 ml of test-drink containing either fructose ( 0.75 g/kg bodyweight ) or sucralose ( sweetness-matched with fructose drink ) ; 45 minutes later , baseline and flow-mediated dilatation was re-measured .


Pre-drink and post-drink baseline values were similar on two occasions ( p > 0.05 ) .


Brachial artery diameter increased ( p < 0.05 ) by 7 + / - 3 % pre-fructose and by 6.9 + / - 3 % above baseline values post-fructose with no significant difference in these responses ( p < 0.15 ) .


It increased ( p < 0.05 ) by 5.9 + / - 3 % above baseline before and by 6.7 + / - 2 % ( p < 0.01 ) after sucralose ; a significant difference was noted in these flow-mediated dilatation responses ( p < 0.02 ) .


Responses before and after sucralose were not different from those before and after fructose ( p < 0.294 ) .


Acute ingestion of fructose or sucralose had no effect on flow-mediated dilatation measured at brachial artery .


Sublingual immunotherapy with liquid extracts provides an appealing alternative to subcutaneous immunotherapy for the treatment of allergic rhinoconjunctivitis ( ARC ) , but a lack of robust evidence has deterred its use in North America .


To determine the efficacy and tolerability of standardized glycerinated short ragweed sublingual allergen immunotherapy liquid ( RW-SAIL ) extract in subjects with ragweed-related ARC .


This phase 3 , randomized , placebo-controlled trial was conducted in North America .


Subjects ( age range , 18-55 years ) with or without asthma were selected based on ARC symptom severity and erythema skin prick reaction to short ragweed .


Subjects self-administered the maximum tolerated dose of RW-SAIL ( n = 218 ) or placebo ( n = 211 ) daily beginning approximately 8 to 16 weeks before and through the end of the ragweed pollen season .


The primary end point was subject-assessed total combined daily rhinoconjunctivitis symptom and medication scores ( TCS ) .


During the entire season , there was a 43 % decrease in TCS in subjects treated with RW-SAIL compared with placebo .


Similar decreases were observed in TCS between the 2 groups during peak season ( 42 % ) and in daily symptom scores during the entire ( 42 % ) and peak ( 41 % ) seasons .


The occurrence of adverse events was similar between the treatment groups ; most were mild in severity .


Treatment-related oromucosal local application site reactions occurred early and were transient and self-limited .


No anaphylaxis occurred .


This is the first successful North American confirmatory phase 3 clinical trial to demonstrate the safety and efficacy of a sublingual standardized ragweed allergen immunotherapy liquid extract for the treatment of ARC .


This study determined the correlation between the levels of reactive oxygen species ( ROS ) in prepared culture media and the early development of human embryos .


This was an autocontrolled comparison study .


A total of 159 patients undergoing invitro fertilization/intracytoplasmic sperm injection treatment were recruited in this study .


The pH values , osmolarity pressures , and ROS levels of 15 batches of two culture media were measured .


Sibling oocytes or embryos from individual patients were randomly assigned to two culture groups with Quinn 's Advantage Cleavage and Blastocyst media ( QAC/QAB ) or GIII series cleavage and blastocyst media ( G1 .3 / G2 .3 ) .


The difference between the two culture groups was analyzed using one-sample t test .


The QAC/QAB and G1 .3 / G2 .3 media exhibited similar pH values and osmolarity pressures .


However , the prepared QAC/QAB media were characterized to contain lower amounts of ROS than the G1 .3 / G2 .3 media .


Furthermore , the blastocysts that developed under the QAC/QAB media were morphologically superior to those that developed under the G1 .3 / G2 .3 media .


The elevated ROS levels in culture media were associated with poor development of blastocyst-stage embryos .


Measurement of ROS levels may be a valuable process for medium selection or modification .


Necitumumab is a second-generation , recombinant , human immunoglobulin G1 EGFR antibody .


In this study , we aimed to compare treatment with necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone in patients with previously untreated stage IV squamous non-small-cell lung cancer .


We did this open-label , randomised phase 3 study at 184 investigative sites in 26 countries .


Patients aged 18 years or older with histologically or cytologically confirmed stage IV squamous non-small-cell lung cancer , with an Eastern Cooperative Oncology Group ( ECOG ) performance status of 0-2 and adequate organ function and who had not received previous chemotherapy for their disease were eligible for inclusion .


Enrolled patients were randomly assigned centrally 1:1 to a maximum of six 3-week cycles of gemcitabine and cisplastin chemotherapy with or without necitumumab according to a block randomisation scheme ( block size of four ) by a telephone-based interactive voice response system or interactive web response system .


Chemotherapy was gemcitabine 1250 mg/m ( 2 ) administered intravenously over 30 min on days 1 and 8 of a 3-week cycle and cisplatin 75 mg/m ( 2 ) administered intravenously over 120 min on day 1 of a 3-week cycle .


Necitumumab 800 mg , administered intravenously over a minimum of 50 min on days 1 and 8 , was continued after the end of chemotherapy until disease progression or intolerable toxic side-effects occurred .


Randomisation was stratified by ECOG performance status and geographical region .


Neither physicians nor patients were masked to group assignment because of the expected occurrence of acne-like rash -- a class effect of EGFR antibodies -- that would have unmasked most patients and investigators to treatment .


The primary endpoint was overall survival , analysed by intention to treat .


We report the final clinical analysis .


This study is registered with ClinicalTrials.gov , number NCT00981058 .


Between Jan 7 , 2010 , and Feb 22 , 2012 , we enrolled 1093 patients and randomly assigned them to receive necitumumab plus gemcitabine and cisplatin ( n = 545 ) or gemcitabine and cisplatin ( n = 548 ) .


Overall survival was significantly longer in the necitumumab plus gemcitabine and cisplatin group than in the gemcitabine and cisplatin alone group ( median 115 months [ 95 % CI 104-126 ] ) vs 99 months [ 89-111 ] ; stratified hazard ratio 084 [ 95 % CI 074-096 ; p = 001 ] ) .


In the necitumumab plus gemcitabine and cisplatin group , the number of patients with at least one grade 3 or worse adverse event was higher ( 388 [ 72 % ] of 538 patients ) than in the gemcitabine and cisplatin group ( 333 [ 62 % ] of 541 ) , as was the incidence of serious adverse events ( 257 [ 48 % ] of 538 patients vs 203 [ 38 % ] of 541 ) .


More patients in the necitumumab plus gemcitabine and cisplatin group had grade 3-4 hypomagnesaemia ( 47 [ 9 % ] of 538 patients in the necitumumab plus gemcitabine and cisplatin group vs six [ 1 % ] of 541 in the gemcitabine and cisplatin group ) and grade 3 rash ( 20 [ 4 % ] vs one [ < 1 % ] ) .


Including events related to disease progression , adverse events with an outcome of death were reported for 66 ( 12 % ) of 538 patients in the necitumumab plus gemcitabine and cisplatin group and 57 ( 11 % ) of 541 patients in the gemcitabine and cisplatin group ; these were deemed to be related to study drugs in 15 ( 3 % ) and ten ( 2 % ) patients , respectively .


Overall , we found that the safety profile of necitumumab plus gemcitabine and cisplatin was acceptable and in line with expectations .


Our findings show that the addition of necitumumab to gemcitabine and cisplatin chemotherapy improves overall survival in patients with advanced squamous non-small-cell lung cancer and represents a new first-line treatment option for this disease .


Eli Lilly and Company .


Motor imagery ( MI ) has been used as a complementary therapeutic tool for motor recovery after central nervous system disease and peripheral injuries .


However , it has never been used as a preventive tool .


We investigated the use of MI in the rehabilitation of stage II shoulder impingement syndrome .


For the first time , MI is used before surgery .


Sixteen participants were randomly assigned to either a MI or control group .


Shoulder functional assessment ( Constant score ) , range of motion and pain were measured before and after intervention .


Higher Constant score was observed in the MI than in the control group ( p = 0.04 ) .


Participants in the MI group further displayed greater movement amplitude ( extension ( p < 0.001 ) ; flexion ( p = 0.025 ) ; lateral rotation ( p < 0.001 ) .


Finally , the MI group showed greater pain decrease ( p = 0.01 ) .


MI intervention seems to alleviate pain and enhance mobility , this is probably due to changes in muscle control and consequently in joint amplitude .


MI might contribute to postpone or even protect from passing to stage III that may require surgery .


Implications for Rehabilitation Adding motor imagery training to classical physical therapy in a stage II impingement syndrome : Helps in alleviating pain Enhances shoulder mobility Motor imagery is a valuable technique that can be used as a preventive tool before the stage III of the impingement syndrome .


Insulin sensitivity often decreases after surgery in spite of normal insulin secretion , and may worsen the outcome .


This post-operative insulin resistance increases according to the magnitude of surgical invasion .


However , supplementation of carbohydrates before surgery attenuates the post-operative insulin resistance .


This study aimed to investigate the effect of intra-operative administration of low-dose glucose on the post-operative insulin resistance .


Patients undergoing maxillofacial surgery were randomly assigned to two groups throughout the surgical procedure : The glucose group receiving acetated Ringer solution with 1.5 % glucose and the control group receiving acetated Ringer solution without glucose .


Insulin resistance quantified by the mean glucose infusion rate ( the glucose infusion rate ) was evaluated by glucose clamp using the STG-22TM instrument on the previous day and on the next day of surgery .


Blood glucose level was monitored continuously during surgery .


In addition , serum insulin , ketone bodies and 3-methylhistidine were measured during perioperative period .


Patients in the glucose group ( n = 11 ) received 0.15 0.06 g/kg/h of glucose during surgery , while patients in the control group ( n = 11 ) received no glucose .


In both groups , however , the mean blood glucose levels were maintained stable at less than 150 mg/dL during and after surgery .


The serum ketone bodies significantly increased after surgery in the control group ( p = 0.0035 ) , while it decreased significantly in the glucose group ( p = 0.043 ) .


The reduction rate in the glucose infusion rate was significantly lower in the glucose group , 43.3 20.7 % , than that in the control group , 57.7 9.3 % ( p = 0.041 ) .


Intra-operative small-dose of glucose administration may suppress ketogenesis and attenuate the post-operative insulin resistance without causing hyperglycemia .


To evaluate the efficacy of transcervical intralesional vasopressin injection to submucous myoma in hysteroscopic myomectomy from 2011 to 2014 .


This was a prospective , randomized , double-blind study in a single center .


Forty premenopausal women with symptomatic submucous myoma requiring hysteroscopic myomectomy were randomized to transcervical intralesional vasopressin injection or placebo in a 4:4 ratio .


The primary outcome was operative time .


Secondary outcomes including fluid volumes , blood loss , and visual clarity were compared between the two groups .


The median duration for myomectomy was 19.9 minutes ( range 3.1-54 .2 minutes ) in the vasopressin group compared with 29.0 minutes ( range 8.0-60 .9 minutes ) in the placebo group , a nonsignificant difference ( P = .14 ) .


There were significant reductions in the median volume of fluid used ( 4,200 mL [ range 1,300-21 ,000 mL ] compared with 9,800 mL ( range 1,500-23 ,000 mL ; P = .004 ) and fluid intravasation ( 0 mL [ range 0-3 ,100 ] compared with 300 mL [ range -150 -3,150 mL ; P = .029 ) in the vasopressin group .


The median intraoperative blood loss was reduced ( 5 mL [ range 1-50 mL ] compared with 20 mL [ range 1-150 mL ; P = .002 ) .


The operative surgeon rated that 95 % of the vasopressin group had `` minimal '' bleeding compared with 36.8 % in the placebo group .


The surgical field ( visual analog scale [ VAS ] 9 [ range 2-10 ] compared with 6 [ range 2-10 ; P < .001 ] ; 0 = worst visual clarity , 10 = best visual clarity ) and the effluent fluid ( VAS 1 [ range 0-7 ] compared with 4 [ range 0-8 ; P < .001 ] ; 0 = clear , 10 = unclear ) were statistically significantly clearer in the vasopressin group .


Transcervical intralesional vasopressin injection in hysteroscopic myomectomy did not reduce operative time but did reduce volume of inflow fluid , fluid intravasation , intraoperative blood loss , and improving visual clarity .


Centre for Clinical Research and Biostatistics , http://www.cct.cuhk.edu.hk/Registry/publictriallist.aspx , CUHK_CCT00291 .


Postoperative nausea and vomiting ( PONV ) are frequent but unwanted complications for patients following anaesthesia and cardiac surgery , affecting at least a third of patients , despite pharmacological treatment .


The primary aim of the proposed research is to test the efficacy of PC6 acupoint stimulation versus placebo for reducing PONV in cardiac surgery patients .


In conjunction with this we aim to develop an understanding of intervention fidelity and factors that support , or impede , the use of PC6 acupoint stimulation , a knowledge translation approach .


712 postcardiac surgery participants will be recruited to take part in a two-group , parallel , superiority , randomised controlled trial .


Participants will be randomised to receive a wrist band on each wrist providing acupressure to PC six using acupoint stimulation or a placebo .


Randomisation will be computer generated , use randomly varied block sizes , and be concealed prior to the enrolment of each patient .


The wristbands will remain in place for 36h .


PONV will be evaluated by the assessment of both nausea and vomiting , use of rescue antiemetics , quality of recovery and cost .


Patient satisfaction with PONV care will be measured and clinical staff interviewed about the clinical use , feasibility , acceptability and challenges of using acupressure wristbands for PONV .


Ethics approval will be sought from appropriate Human Research Ethics Committee/s before start of the study .


A systematic review of the use of wrist acupressure for PC6 acupoint stimulation reported minor side effects only .


Study progress will be reviewed by a Data Safety Monitoring Committee ( DSMC ) for nausea and vomiting outcomes at n = 350 .


Dissemination of results will include conference presentations at national and international scientific meetings and publications in peer-reviewed journals .


Study participants will receive a one-page lay-summary of results .


Australian New Zealand Clinical Trials Registry -- ACTRN12614000589684 .


To compare the effects of occlusal appliance therapy ( OA ) and therapist-guided relaxation training ( RT ) on temporomandibular disorder ( TMD ) pain in adolescents , thereby replicating a previous randomized controlled trial , and to explore whether additional therapy administered in a crossover sequential design improves treatment outcomes .


The study involved 64 adolescents , aged 12 to 19 years , experiencing TMD pain at least once a week and diagnosed with myofascial pain in accordance with the Research Diagnostic Criteria for TMD .


For phase 1 of the study , subjects were randomly assigned to OA or RT ; nonresponders were offered the other treatment in phase 2 .


Self-reports of TMD pain and clinical assessments were performed before and after treatment in each phase and 6 months after the last treatment phase .


Differences in outcomes between treatment groups across the different phases were analyzed by analysis of covariance ( ANCOVA ) , and for differences in proportions , the chi-square test was used .


After phase 1 , a significantly higher proportion of adolescents treated with OA ( 62.1 % ) than those treated with RT ( 17.9 % ) responded to treatment , defined as a subjective report of `` Completely well/Very much improved '' or `` Much improved . ''


Similar differences in self - report of treatment effect occurred after phase 2 .


About two-thirds of all adolescents in both phases reported such an improvement level at the 6-month follow-up , including a somewhat higher proportion of phase 1 responders ( 79.2 % ) than phase 1 nonresponders ( 60 % ) .


The findings suggest that , for adolescents with TMD pain , use of standardized clinical treatment with OA is more effective than RT on self-evaluation of treatment improvement .


For nonresponders , subsequent crossover treatment might be useful to improve subjective TMD pain .


The objective of this study is to determine the effect of intravenous ( i.v. ) or oral N-acetylcysteine ( NAC ) in preventing contrast-induced nephropathy ( CIN ) in patients with moderate-to-severe renal insufficiency undergoing intra-arterial interventions .


We studied 307 patients with estimated glomerular filtration rate of less than 60 ml/min/1 .73 m undergoing an elective intra-arterial procedure .


Patients were assigned randomly to three groups according to the prophylactic regimen used .


In group 1 , patients were administered an i.v. infusion of 0.9 % saline ( n = 103 ) ; in group 2 , patients were administered oral NAC in addition to an i.v. saline infusion ( n = 102 ) ; and in group 3 , patients were administered i.v. NAC in addition to an i.v. saline infusion ( n = 102 ) .


Serum creatinine ( SCr ) and cystatin C levels were measured at baseline and 4 , 24 , and 48 h after the application of contrast media .


The primary endpoint was defined as an increase in the SCr or cystatin C concentration of at least 0.5 mg/dl and/or of at least 25 % from the baseline value at 48 h after administration of the contrast dye .


The overall incidence of SCr-based CIN was 11.1 % : 6.8 % in the saline group , 13.7 % in the oral NAC group , and 12.7 % in the i.v. NAC group ( P = 0.231 ) .


That of cystatin C-based CIN was 8.1 % : 6.8 % in the saline group , 6.9 % in the oral NAC group , and 10.8 % in the i.v. NAC group ( P = 0.491 ) .


In this study , there was no detectable benefit of either high-dose oral or i.v. NAC over an aggressive hydration protocol in patients with moderate-to-severe renal insufficiency .


Neuromodulation techniques , i.e. repetitive transcranial magnetic stimulation ( rTMS ) and transcranial direct current stimulation ( tDCS ) , can modify cerebral hemodynamics .


High frequency rTMS appeared to decrease cerebral vasomotor reactivity ( VMR ) , while there is still poor evidence about the effect of low frequency ( LF ) rTMS on cerebral blood flow ( CBF ) and VMR .


The present study aimed to test if LF rTMS decreases CBF and increases cerebral VMR .


Monolateral or bilateral hemispheric involvement and duration of the effect were considered .


A possible role of autonomic nervous system in CBF and VMR modulation was also investigated .


Twenty-four right-handed healthy subjects underwent randomly real ( 12 ) or sham ( 12 ) 20-min 1-Hz rTMS on left primary motor cortex .


Mean flow velocity and VMR of middle cerebral arteries were evaluated by means of transcranial Doppler before ( T0 ) , after 10 min ( T1 ) and after 2 ( T2 ) , 5 ( T3 ) and 24 h ( T4 ) from rTMS .


Heart rate variability ( HRV ) was studied within the same timing interval , assessing low frequency/high frequency ( LF/HF ) ratio as index of autonomic balance .


After real rTMS compared with sham stimulation , MFV decreased bilaterally at T1 ( F = 3.240 , P = .030 ) while VMR increased bilaterally ( F = 5.116 , P = .002 ) for at least 5 h ( T3 ) .


LF/HF ratio decreased early after real rTMS ( F = 2.881 , P = .040 ) .


1-Hz rTMS may induce a bilateral long-lasting increase of VMR , while its effect on MFV is short-lasting .


Moreover , HRV changes induced by rTMS suggest a possible autonomic nervous system modulation .


Heme oxygenase 1 ( HO-1 ) degrades heme and protects against oxidative stress .


In vitro and animal models suggest that HO-1 is beneficial in several diseases ( e.g. , postoperative ileus , gastroparesis , acute pancreatitis , and colitis ) .


However , the only drugs ( i.e. , hemin and heme arginate ) which pharmacologically upregulate HO-1 in humans are expensive and can only be administered intravenously .


Our aims were to compare the effects of placebo , aspirin , and simvastatin alone , and with - lipoic acid , on HO-1 protein concentration and activity in humans .