Sixty-four patients with rectal cancer were randomly divided into the research group ( @ cases ) to receive laparoscopic assisted rectal cancer resection using ENDO RLC general endoscopic linear cutter and single-use loading unit and circular staplers with staples ( from REACH medical equipment co.LTD ) and the control group ( @ cases ) to receive surgery with the corresponding products widely used ( fom Johnson and Johnson Medical Euipment C.Ltd ) .


The clinical data of the two groups were compared .


Satisfactory therapeutic effects were obtained in all the cases .


The two groups showed no significant differences in the operative time , intraoperative anastomosis success rate , or postoperative complications ( anastomotic bleeding , leakage , or stricture ) between the two groups ( P > @ ) , but the average cost of endoscopic stapling instrument was significantly lower in the research group ( @ @ vs @ @ RMB Yuan , P < @ ) .


The domestic endoscopic stapling instrument is safe , effective and less costly for laparoscopic assisted rectal cancer resection .


Axitinib is a potent and selective inhibitor of vascular endothelial growth factor receptors @-@ .


This analysis compared efficacy and safety of axitinib plus gemcitabine in patients with advanced pancreatic cancer from Japan , North America and the European Union , enrolled in a randomized Phase III study .


Patients ( n = @ ) , stratified by disease extent , were randomly assigned ( @:@ ) to receive axitinib/gemcitabine or placebo/gemcitabine .


Axitinib was administered at a starting dose of @ mg orally twice daily and gemcitabine at @ mg/m ( @ ) once weekly for @ weeks in @ week cycles .


Primary endpoint was overall survival .


Among Japanese patients , median overall survival was not estimable ( @ % confidence interval , @ months-not estimable ) with axitinib/gemcitabine ( n = @ ) and @ months ( @ % confidence interval , @-@ @ ) with placebo/gemcitabine ( n = @ ) ( hazard ratio @ -LSB- @ % confidence interval , @-@ @ -RSB- ) .


Median survival follow-up ( range ) was @ months ( @-@ @ ) with axitinib/gemcitabine vs. @ months ( @-@ @ ) with placebo/gemcitabine .


Similarly , no difference was detected in overall survival between axitinib/gemcitabine and placebo/gemcitabine in patients from North America or the European Union .


Common adverse events with axitinib/gemcitabine in Japanese patients were fatigue , anorexia , dysphonia , nausea and decreased platelet count .


Axitinib safety profile was generally similar in patients from the three regions , although there were differences in incidence of some adverse events .


An exploratory analysis did not show any correlation between axitinib/gemcitabine-related hypertension and overall survival .


Axitinib/gemcitabine , while tolerated , did not provide survival benefit over gemcitabine alone in patients with advanced pancreatic cancer from Japan or other regions .


Bypass Angioplasty Revascularization Investigation @ Diabetes ( BARI @D ) was a study of management strategies for diabetic patients with myocardial ischemia and coronary artery disease .


In a @ design , early revascularization versus medical management with or without late revascularization and insulin sensitization versus insulin provision were examined .


No advantage for either strategy was seen , except in the group undergoing early coronary artery bypass grafting ( CABG ) .


In that group , a reduction in subsequent myocardial infarction was noted .


The purpose of our report was to characterize the conduct and short-term outcomes for CABG that led to this result .


Data from the BARI @D CABG stratum were collected , including the baseline demographic and cardiovascular characteristics , technical details of the operation , and perioperative morbidity and mortality , and analyzed .


A total of @ patients were studied .


The average cardiac function was normal , and most had multivessel disease .


Almost all had undergone CABG by way of a median sternotomy using an internal mammary artery , and one third were off pump .


The perioperative morbidity and mortality were low and compared well with larger outcomes databases .


BARI @D showed that early CABG in patients with type @ diabetes and myocardial ischemia and multivessel disease reduced the subsequent myocardial infarction rates .


The present results have demonstrated that this was achieved using off-pump surgery in certain cases , standard myocardial protection , and routine use of the internal mammary artery or other arterial grafts .


Interpretive front-of-pack nutrition labels are better understood than non-interpretive labels .


However , robust evidence on the effects of such labels on consumer food purchases in the real-world is lacking .


Our aim is to assess the effects of two interpretive front-of-pack nutrition labels , compared with a non-interpretive label , on the healthiness of consumer food purchases .


A five-week ( @-week baseline and @-week intervention ) three-arm parallel randomised controlled trial will be conducted using a bespoke smartphone application , which will administer study questionnaires and deliver intervention ( Multiple Traffic Light and Health Star Rating ) and control ( Nutrition Information Panel ) labels .


To view their allocated nutrition label , participants scan the barcode of packaged food products using their smartphone camera .


The assigned label is displayed instantly on the smartphone screen @ eligible participants ( New Zealand adult smartphone owners who shop in a supermarket at least once a week and are main household shoppers ) will be randomised in a @:@:@ ratio to one of the three nutrition label formats , using computer-generated randomisation sequences .


Randomisation will be stratified by ethnicity and interest in healthy eating .


Food and beverage purchase data will be collected continuously throughout the study via hard copy till receipts and electronic grocery purchase lists recorded and transmitted using the smartphone application .


The primary outcome will be healthiness of food purchases in each trial arm , assessed as mean Food Standards Australia New Zealand nutrient profiling score criterion score for all food and beverages purchased over the intervention period .


Secondary outcomes will include saturated fat , sugar , sodium and energy content of food purchases ; food expenditure ; labelling profile of food purchases ( i.e. mean number of Health Star Rating stars and proportion of red , green and amber traffic lights ) ; nutrient profiling score over time and by food categories ; purchases of unpackaged foods ; self-reported nutrition knowledge and recorded use of assigned labelling system .


The Starlight randomised , controlled trial will determine the effects of interpretive front-of-pack nutrition labels on the healthiness of consumer food purchases in the real world .


A gene-based estimate of lung cancer risk in smokers has been shown to act as a smoking cessation motivator in hospital recruited subjects .


The objective of this trial is to determine if this motivator is as effective in subjects recruited from an NHS primary care unit .


Subjects will be recruited by mailings using smoking entries on the GP electronic data-base ( total practice population = @,@ ) to identify smokers who may want to quit .


Smoking cessation clinics based on medical centre premises will run for eight weeks .


Clinics will be randomised to have the gene-based test for estimation of lung cancer risk or to act as controls groups .


The primary endpoint will be smoking cessation at eight weeks and six months .


Secondary outcomes will include ranking of the gene-based test with other smoking cessation motivators .


The results will inform as to whether the gene-based test is both effective as motivator and acceptable to subjects recruited from primary care .


Acid suppressant drugs are a mainstay of treatment for cats with gastrointestinal erosion and ulceration .


However , clinical studies have not been performed to compare the efficacy of commonly PO administered acid suppressants in cats .


To compare the effect of PO administered famotidine , fractionated omeprazole tablet ( fOT ) , and omeprazole reformulated paste ( ORP ) on intragastric pH in cats .


We hypothesized that both omeprazole formulations would be superior to famotidine and placebo .


Six healthy adult DSH colony cats .


Utilizing a randomized , @-way crossover design , cats received @-@ @ mg/kg PO q@h fOT , ORP , famotidine , and placebo ( lactose capsules ) .


Intragastric pH monitoring was used to continuously record intragastric pH for @ hours beginning on day @ of treatment .


Plasma omeprazole concentrations at steady state ( day @ ) were determined by high performance liquid chromatography ( HPLC ) with ultraviolet detection .


Mean percentage time that intragastric pH was @ and @ were compared among groups using ANOVA with a posthoc Tukey-Kramer test ( = @ ) .


The mean percentage time SD that intragastric pH was @ was @ @ % for fOT , @ @ % for ORP , @ @ % for famotidine , and @ @ % for placebo .


Mean SD plasma omeprazole concentrations were similar in cats receiving fOT compared to those receiving ORP and in a range associated with acid suppression reported in other studies .


These results suggest that both omeprazole formulations provide superior acid suppression in cats compared to famotidine or placebo .


Fractionated enteric-coated OT is an effective acid suppressant despite disruption of the enteric coating .


Recent publications show that heat-mediated tissue tightening is a promising treatment for the lax abdomen and may provide better long-term outcomes than traditional suction-assisted liposuction ( SAL ) .


The author evaluates the degree and duration of skin surface area contraction , as well as the influence of anatomic location of the treatment region on the degree of tissue tightening , in a study comparing SAL alone vs SAL plus radiofrequency-assisted liposuction ( RFAL ) .


In this prospective , randomized , split abdominal study , @ consecutive patients were treated with SAL alone on @ side and with SAL plus RFAL on the other side .


Each patient had @ ( @ @-cm ) squares-@ per treatment type-tattooed in the lower abdominal region ( @ on the right and @ on the left ) .


The surface area of these squares was measured with the Vectra computerized measurement system ( Canfield , Inc , Fairfield , New Jersey ) at pretreatment , at @ weeks posttreatment , and at @ year posttreatment .


All measurements were subjected to statistical analysis using predictive analytic software and were evaluated for statistical significance .


In regions treated with SAL alone , there was a @ % mean skin surface area contraction at @ weeks and @ % at @ year posttreatment .


The mean skin surface area reduction was @ % in regions treated with radiofrequency plus SAL at @ weeks and at @ year .


The anatomic location of each square ( medial vs lateral ) did not statistically correlate with more or less tissue tightening .


Radiofrequency-assisted tissue tightening , when applied in conjunction with SAL , is effective in achieving greater skin surface area reduction .


Inhalation therapy is the main treatment for asthma and its adequate use has been a factor responsible for disease control ; therefore , the aim of the study was to determine whether a digital media tool , which features portability on mobile phones , modifies the assimilation of the inhalation technique .


A total of @ professionals working in the health care area with the pediatric population were selected .


They were submitted to a pre-test on their knowledge of inhalation therapy .


The professionals were randomized into two groups ( A and B ) .


Group A received a media application on their mobile phones showing the steps of inhalation therapy , while group B received the same information in written form only .


A post-test was applied after @ days .


The results ( pre - and post - ) were analyzed by two pediatric pulmonologists .


Of the @ professionals , @ % were females .


Of a total possible score of ten , the mean score obtained in the pre-test was @ @ , and in the second test , @ @ ( p < @ ) .


There were no significant differences when comparing the two groups ( p = @ ) .


The nurses had the lowest mean scores in the initial test ( @ @ ) ; however , they were the group that learned the most with the intervention , showing similar means to those of other groups in the second test ( @ @ ) .


There was significant improvement in knowledge about inhalation therapy in all professional categories using both methods , demonstrating that education , when available to professionals , positively modifies medical practice .


Succinylcholine a depolarizing muscle relaxant with rapid onset , predictable course and short duration of action is associated with myalgia .


The aim of this study is to evaluate the efficacy of pregabalin , gabapentin and diclofenac on the incidence and severity of succinylcholine-induced myalgia .


Tertiary Care Teaching Hospital .


A total of @ patients undergoing laparoscopic cholecystectomy were randomly assigned into three groups : Pregabalin group received @ mg of pregabalin , gabapentin group received @ mg of gabapentin and diclofenac group received @ mg of diclofenac sodium orally @ h prior to surgery .


Anesthesia was induced with fentanyl @ g/kg , propofol @-@ @ mg/kg and succinylcholine @ mg/kg and was maintained with oxygen with sevoflurane in the air and intermittent vecuronium bromide .


A blinded observer recorded post-operative pain scores on visual analog scale at different time intervals and myalgia at @ h. Post-operative pain relief was provided with fentanyl based patient-controlled analgesia .


Fentanyl consumption in @ h was recorded as a primary outcome .


Patients ' characteristics and total fentanyl consumption were compared using one-way ANOVA followed by post-hoc test .


Pain score was compared amongst the groups using Kruskal Wallis test .


The myalgia occurred in @ , @ and @ patients in pregabalin , gabapentin and diclofenac sodium group respectively ( P > @ ) .


Patients in diclofenac group had significantly higher fentanyl consumption ( @ @ g ) compared with pregabalin group ( @ @ g ) ( @ % confidence interval -LSB- CI -RSB- = @-@ @ ) and gabapentin group ( @ @ g ) ( @ % CI = @-@ @ ) .


However , there was no significant difference in fentanyl consumption between pregabalin and gabapentin groups ( @ % CI = -@ -@ ) .


There was a significant difference in visual analog score at time points @ , @ and @ h among the study groups .


Pre-treatment with pregabalin , gabapentin and diclofenac had equal efficacy in reducing the incidence and severity of succinylcholine-induced myalgia .


However , pre-treatment with pregabalin and gabapentin decreased post-operative pain scores and fentanyl consumption .


To undertake a five year follow up of a cohort of women and children delivered by forceps or vacuum extractor in a randomised controlled study .


Follow up of a randomised controlled trial .


District general hospital in the West Midlands .


Follow up questionnaires were sent to @ of the @ women originally recruited at the North Staffordshire Hospital to a randomised controlled study comparing forceps and vacuum extractor for assisted delivery .


Two hundred and twenty-eight women responded ( @ % ) and all were included in the study ; forceps ( n = @ ) and vacuum extractor ( n = @ ) .


Bowel and urinary dysfunction , child vision assessment , and child development .


Maternal adverse symptoms at long term follow up were relatively common .


Urinary incontinence of various severity was reported by @ % , bowel habit urgency was reported by @ % ( @/@ ) , and loss of bowel control ` sometimes ' or ` frequently ' by @ % of women ( @/@ ) .


No significant differences between instruments were found in terms of either bowel or urinary dysfunction .


Overall , @ % ( @/@ ) of children were noted to have visual problems .


There was no significant difference in visual function between the two groups : ventouse @/@ ( @ % ) , compared with forceps @/@ ( @ % ) ; odds ratio @ , @ % CI @-@ @ .


Of the @ children with visual problems , a family history was known in @ , and @/@ ( @ % ) had a positive family history for visual problems .


No significant differences in child development were found between the two groups .


There is no evidence to suggest that at five years after delivery use of the ventouse or forceps has specific maternal or child benefits or side effects .


Recently , we documented the likely non-inferiority of Combinatietherapie Bij Reumatode Artritis ( COBRA ) - light therapy ( methotrexate increased to @mg/week with initial prednisolone @mg/day ) compared with the original COBRA therapy ( methotrexate @ mg/week , sulfasalazine @g/day , with initial prednisolone @mg/day ) after @weeks in patients with early active rheumatoid arthritis ( RA ) .


To assess the non-inferiority of COBRA-light versus COBRA after @year in terms of disease activity ( DAS@ ) , functional outcome ( Health Assessment Questionnaire ( HAQ ) ) and radiographic progression ( Sharp/van der Heijde score ( SHS ) ) , and to assess the effect of adding etanercept .


An open-label , randomised controlled , non-inferiority trial of @ patients with active early RA , following a treat-to-target protocol incorporating the addition of etanercept if DAS@ @ at weeks @ or @ .


Both groups showed major improvements in DAS@ after @weeks : mean ( SD ) -@ ( @ ) in the COBRA and -@ ( @ ) in the COBRA-light group ( p = ns ) .


In both groups , functional ability improved and radiological progression of joints was minimal .


At least one adverse event was reported in @ % of the patients in both groups .


In total , @ serious adverse events occurred : @ vs @ in COBRA and COBRA-light , respectively .


Treatment actually instituted was often less intensive than required by the protocol : of the total population , @ patients ( @ % ) required etanercept ( more in the COBRA-light group ) , but only @ of these ( @ % ) actually received it .


Intensive COBRA or COBRA-light therapy has major , comparably favourable effects on disease activity , functional ability and radiological outcome after @year in patients with early RA .


Protocolised addition of etanercept was often not implemented by treating rheumatologists , and patients receiving it appeared to have limited added benefit , probably because of low disease activity levels at its initiation .


This study compared time-to-hospitalization among subjects enrolled in different diabetes self-management programs ( DSMP ) .


We sought to determine whether the interventions delayed the occurrence of any acute event necessitating hospitalization .


Electronic medical records ( EMR ) were obtained for @ adults enrolled in a randomized controlled trial ( RCT ) of Type @ diabetes ( T@DM ) self-management programs .


All study participants had uncontrolled diabetes and were randomized into either : personal digital assistant ( PDA ) , Chronic Disease Self-Management Program ( CDSMP ) , combined PDA and CDSMP ( COM ) , or usual care ( UC ) groups .


Subjects were followed for a maximum of two years .


Time-to-hospitalization was measured as the interval between study enrollment and the occurrence of a diabetes-related hospitalization .


Subjects enrolled in the CDSMP-only arm had significantly prolonged time-to-hospitalization ( Hazard ratio : @ ; p = @ ) when compared to subjects in the control arm .


Subjects in the PDA-only and combined PDA and CDSMP arms showed no improvements in comparison to the control arm .


CDSMP can be effective in delaying time-to-hospitalization among patients with T@DM .


Reducing unnecessary healthcare utilization , particularly inpatient hospitalization is a key strategy to improving the quality of health care and lowering associated health care costs .


The CDSMP offers the potential to reduce time-to-hospitalization among T@DM patients .


The benefit of CT coronary angiography ( CTCA ) in patients presenting with stable chest pain has not been systematically studied .


We aimed to assess the effect of CTCA on the diagnosis , management , and outcome of patients referred to the cardiology clinic with suspected angina due to coronary heart disease .


In this prospective open-label , parallel-group , multicentre trial , we recruited patients aged @-@ years referred for the assessment of suspected angina due to coronary heart disease from @ cardiology chest pain clinics across Scotland .


We randomly assigned ( @:@ ) participants to standard care plus CTCA or standard care alone .


Randomisation was done with a web-based service to ensure allocation concealment .


The primary endpoint was certainty of the diagnosis of angina secondary to coronary heart disease at @ weeks .


All analyses were intention to treat , and patients were analysed in the group they were allocated to , irrespective of compliance with scanning .


This study is registered with ClinicalTrials.gov , number NCT@ .


Between Nov @ , @ , and Sept @ , @ , we randomly assigned @ ( @ % ) of @ patients who had been referred for assessment of suspected angina due to coronary heart disease .


@ % of participants had a baseline clinic diagnosis of coronary heart disease and @ % had angina due to coronary heart disease .


At @ weeks , CTCA reclassified the diagnosis of coronary heart disease in @ ( @ % ) patients and the diagnosis of angina due to coronary heart disease in @ ( @ % ) patients ( standard care @ -LSB- @ % -RSB- and @ -LSB- @ % -RSB- ; p < @ ) .


Although both the certainty ( relative risk -LSB- RR -RSB- @ , @ % CI @-@ ; p < @ ) and frequency of coronary heart disease increased ( @ , @-@ ; p = @ ) , the certainty increased ( @ , @-@ ; p < @ ) and frequency seemed to decrease ( @ , @-@ ; p = @ ) for the diagnosis of angina due to coronary heart disease .


This changed planned investigations ( @ % vs @ % ; p < @ ) and treatments ( @ % vs @ % ; p < @ ) but did not affect @-week symptom severity or subsequent admittances to hospital for chest pain .


After @ years , CTCA was associated with a @ % reduction in fatal and non-fatal myocardial infarction ( @ vs @ , HR @ , @ % CI @-@ ; p = @ ) , but this was not significant .


In patients with suspected angina due to coronary heart disease , CTCA clarifies the diagnosis , enables targeting of interventions , and might reduce the future risk of myocardial infarction .


To evaluate the effect of different polymerization sequences employed during application of bis-GMAbased particulate filler composites ( PFC ) or a flowable resin ( FR ) on fiber-reinforced composite ( FRC ) .


Unidirectional , pre-impregnated S@-glass fibers ( Dentapreg ) and multidirectional preimpregnated E-glass fibers ( Dentapreg ) ( length : @ mm ; thickness : @ mm ) were obtained ( N = @ , n = @ per group ) and embedded in translucent silicone material with the adhesion surface exposed .


The resulting specimens were randomly divided into @ groups for the following application sequences : a ) FRC+PFC ( photopolymerized in one step ) , b ) FRC+FR ( photopolymerized in one step ) , c ) FRC+PFC ( photopolymerized individually ) , d ) FRC+FR ( photopolymerized individually ) , e ) FRC ( photopolymerized ) + intermediate adhesive resin and PFC ( photopolymerized in one step ) , f ) FRC ( photopolymerized ) + intermediate adhesive resin and FR ( photopolymerized in one step ) .


The sequences of unidirectional ( groups a to f ) were repeated for multidirectional ( groups g to l ) FRCs .


PFCs were debonded from the FRC surfaces using the shear bond test in a universal testing machine ( @ mm/min ) .


On additional specimens from each FRC type , thermogravimetric analysis ( TGA ) was performed to characterize the fiber weight content ( Wf ) ( N = @ , n = @ per group ) .


After debonding , all specimens were analyzed using SEM to categorize the failure modes .


The data were statistically analyzed using @-way ANOVA and Tukey 's tests ( = @ ) .


Significant effects of the FRC type ( S@ or E-glass ) ( p < @ ) , resin type ( PFC or FR ) ( p < @ ) and polymerization protocol ( p < @ ) were observed on the bond strength ( MPa ) .


Interaction terms were also significant ( p < @ ) .


The multidirectional FRC groups ( g to l ) showed significantly lower bond strengths ( @ @ to @ @ MPa ) than did the unidirectional FRC groups ( a to f ) ( @ @ to @ @ MPa ) .


Among the unidirectional FRC groups , the highest values were obtained with protocol f ( @ @ ) , followed by protocol e ( @ @ ) .


PFC adhesion to unidirectional FRC was lower when FRC and PFC were polymerized in one step ( protocol a : @ @ ) than individual polymerization ( protocol c : @ @ ) .


The opposite situation was true for FR ( protocol b : @ @ ; protocol d : @ @ ) .


Groups a to f presented exclusively mixed failures ( a combination of partial cohesive failure in the PFC and adhesive failure between the FRC and PFC ) and groups g to l demonstrated only adhesive failure ( intact FRC no cohesive failure of PFC ) .


TGA revealed @ @ wt % fiber content for multidirectional and @ @ wt % for unidirectional FRCs tested .


Multidirectional pre-impregnated E-glass fibers can not be recommended in combination with the PFC and FR materials tested in this study .


Application of an intermediate adhesive resin layer increases the adhesion of both PFC and FR to unidirectional FRC .


FRC and FR can be polymerized in one step , but FRC and PFC combinations should be polymerized individually .


Medium chain triglycerides ( MCT ) enhance thermogenesis and may reduce food intake relative to long chain triglycerides ( LCT ) .


The goal of this study was to establish the effects of MCT on appetite and food intake and determine whether differences were due to differences in hormone concentrations .


Two randomized , crossover studies were conducted in which overweight men consumed @g of MCT or corn oil ( LCT ) at breakfast .


Blood samples were obtained over @h .


In Study @ ( n = @ ) , an ad lib lunch was served after @h .


In Study @ ( n = @ ) , a preload containing @g of test oil was given at @h and lunch was served @h later .


Linear mixed model analyses were performed to determine the effects of MCT and LCT oil on change in hormones and metabolites from fasting , adjusting for body weight .


Correlations were computed between differences in hormones just before the test meals and differences in intakes after the two oils for Study @ only .


Food intake at the lunch test meal after the MCT preload ( Study @ ) was ( means.e.m . )


@kcal vs @kcal after LCT ( P < @ ) .


MCT consumption resulted in a lower rise in triglycerides ( P = @ ) and glucose ( P = @ ) and a higher rise in peptide YY ( PYY , P = @ ) and leptin ( P = @ ) compared with LCT ( combined data ) .


Correlations between differences in hormone levels ( glucagon-like peptide ( GLP-@ ) , PYY ) and differences in food intake were in the opposite direction to expectations .


MCT consumption reduced food intake acutely but this does not seem to be mediated by changes in GLP-@ , PYY and insulin .


High-risk prescribing in primary care is common and causes considerable harm .


Feedback interventions have small/moderate effects on clinical practice , but few trials explicitly compare different forms of feedback .


There is growing recognition that intervention development should be theory-informed , and that comprehensive reporting of intervention design is required by potential users of trial findings .


The paper describes intervention development for the Effective Feedback to Improve Primary Care Prescribing Safety ( EFIPPS ) study , a pragmatic three-arm cluster randomised trial in @ Scottish general practices .


The NHS chose to implement a feedback intervention to utilise a new resource , new Prescribing Information System ( newPIS ) .


The development phase required selection of high-risk prescribing outcome measures and design of intervention components : ( @ ) educational material ( the usual care comparison ) , ( @ ) feedback of practice rates of high-risk prescribing received by both intervention arms and ( @ ) a theory-informed behaviour change component to be received by one intervention arm .


Outcome measures , educational material and feedback design , were developed with a National Health Service Advisory Group .


The behaviour change component was informed by the Theory of Planned Behaviour and the Health Action Process Approach .


A focus group elicitation study and an email Delphi study with general practitioners ( GPs ) identified key attitudes and barriers of responding to the prescribing feedback .


Behaviour change techniques were mapped to the psychological constructs , and the content was informed by the results of the elicitation and Delphi study .


Six high-risk prescribing measures were selected in a consensus process based on importance and feasibility .


Educational material and feedback design were based on current NHS Scotland practice and Advisory Group recommendations .


The behaviour change component was resource constrained in development , mirroring what is feasible in an NHS context .


Four behaviour change interventions were developed and embedded in five quarterly rounds of feedback targeting attitudes , subjective norms , perceived behavioural control and action planning ( @ ) .


The paper describes a process which is feasible to use in the resource-constrained environment of NHS-led intervention development and documents the intervention to make its design and implementation explicit to potential users of the trial findings .


Rectal nonsteroidal anti-inflammatory drugs have been shown to reduce the incidence of postendoscopic retrograde cholangiopancreatography ( ERCP ) pancreatitis ( PEP ) .


The aim of this study was to determine whether intramuscular diclofenac reduces the risk of PEP .


Patients who underwent ERCP were randomized to receive either @mg of diclofenac or placebo by intramuscular injection immediately after the procedure .


PEP was defined as elevated serum amylase levels ( at least three times the upper limit of normal @ hours after the procedure ) associated with new or worsened upper abdominal , epigastric , or back pain .


In total , @ patients were randomized , and @ were eligible for analysis .


The two groups were similar regarding clinical and demographic factors , as well as patient - and procedure-related risk factors for PEP .


PEP developed in @/@ patients ( @ % ) in the placebo group and in @/@ patients ( @ % ) in the diclofenac group ( P = @ ) .


Multivariate regression analysis failed to illustrate that intramuscular diclofenac prevented PEP ( odds ratio @ ; @ % confidence interval @-@ @ ; P = @ ) .


Prophylactic intramuscular diclofenac had no beneficial preventive effect on PEP.Clinicaltrials.gov NCT@ .


Infusion of PDA-@ , a preparation of mesenchymal-like cells derived from full-term human placenta , is a new approach in the treatment of patients with multiple sclerosis .


This safety study aimed to rule out the possibility of paradoxical exacerbation of disease activity by PDA-@ in patients with multiple sclerosis .


This was a phase @b , multicenter , randomized , double-blind , placebo-controlled , @-dose ranging study including patients with relapsing-remitting multiple sclerosis or secondary progressive multiple sclerosis .


The study was conducted at @ sites in the United States and @ sites in Canada .


Patients were randomized @:@ to receive @ low-dose infusions of PDA-@ ( @ ( @ ) cells ) or placebo , given @ week apart .


After completing this cohort , subsequent patients received high-dose PDA-@ ( @ ( @ ) cells ) or placebo .


Monthly brain magnetic resonance imaging scans were performed .


The primary end point was ruling out the possibility of paradoxical worsening of MS disease activity .


This was monitored using Cutters rule ( @ new gadolinium lesions on @ consecutive scans ) by brain magnetic resonance imaging on a monthly basis for six months and also the frequency of multiple sclerosis relapse .


Ten patients with relapsing-remitting multiple sclerosis and @ with secondary progressive multiple sclerosis were randomly assigned to treatment : @ to low-dose PDA-@ , @ to high-dose PDA-@ , and @ to placebo .


No patient met Cutters rule .


One patient receiving high-dose PDA-@ had an increase in T@ and gadolinium lesions and in Expanded Disability Status Scale score during a multiple sclerosis flare @ months after receiving PDA-@ .


No other patient had an increase in Expanded Disability Status Scale score > @ , and most had stable or decreasing Expanded Disability Status Scale scores .


With high-dose PDA-@ , @ patient experienced a grade @ anaphylactoid reaction and @ had grade @ superficial thrombophlebitis .


Other adverse events were mild to moderate and included headache , fatigue , infusion site reactions , and urinary tract infection .


PDA-@ infusions were safe and well tolerated in relapsing-remitting multiple sclerosis and secondary progressive multiple sclerosis patients .


No paradoxical worsening of lesion counts was noted with either dose .


To evaluate the efficacy and toxicity of nedaplatin ( NDP ) concurrent with radiotherapy in the treatment of locally advanced esophageal carcinoma .


Sixty-eight patients with locally advanced esophageal carcinoma were randomized into either a NDP group ( n = @ ) or a cisplatin ( DDP ) group ( n = @ ) .


The NDP group received NDP @-@ mg/m iv on day @ + leucovorin ( CF ) @ mg/m iv on days @-@ + @-fluorouracil ( @-FU ) @ mg/m iv on days @-@ .


The DDP group received DDP @ mg/m iv on days @-@ + CF @ mg/m on days @-@ + @-FU @ mg/m iv on days @-@ .


The treatment was repeated every @ wk in both groups .


Concurrent radiotherapy -LSB- @-@ Gy / ( @-@ f ) / ( @-@ wk ) -RSB- was given during chemotherapy .


There was no significant difference in the short-term response rate between the NDP group and DDP group ( @ % vs @ % , P = @ ) .


Although the @ - and @-year survival rates were higher in the NDP group than in the DDP group ( @ % vs @ % , @ % vs @ % ) , the difference in the overall survival rate was not statistically significant between the two groups ( P = @ ) .


The incidences of nausea , vomiting and nephrotoxicity were significantly lower in the NDP group than in the DDP group ( @ % vs @ % , P = @ ; @ % vs @ % , P = @ ; @ % vs @ % , P = @ ) .


There was no significant difference in the incidence of myelosuppression , radiation-induced esophagitis or radiation-induced pneumonia between the two groups .


NDP-based concurrent chemoradiotherapy is effective and well-tolerated in patients with locally advanced esophageal carcinoma .


NDP-based regimen has comparable efficacy to DDP-based regimen but is associated with lower incidences of gastrointestinal and renal toxicity .


A growing body of studies consistently demonstrates that social responsiveness toward others is influenced by the neurohormone oxytocin .


However , the potential role of oxytocin for self-perception remains relatively unexplored .


Thus , we investigated whether oxytocin administration influences the self-attribution of positive and negative adjectives at the early , effortful stage of self-related information processing .


Sixty healthy male participants received either @I .


U. oxytocin or a placebo in a randomized double-blind study before completing a sorting task , in which they were instructed to co-classify , as fast as possible , positive and negative adjectives into either self or non-self categories .


Oxytocin-treated participants reported stronger positive attitudes toward themselves compared to placebo .


The present findings demonstrate that oxytocin administration influences the early stage of self-related information processing and suggests that the oxytocinergic system might be involved in psychopathological conditions characterized by a negative representation of self .


Nonarteriitic anterior ischemic optic neuropathy ( NAION ) is a leading cause of sudden loss of vision , which particularly affects individuals older than @ years .


Up to now there is no treatment that is effective at reversing or limiting the course of this disease .


To study the short - and long-term effects of fluocortolone ( FC ) on the visual outcome of patients with acute NAION compared to standard treatment with pentoxifylline ( PFX ) .


A prospective , quasirandomized intervention trial was conducted involving @ patients with acute-onset NAION .


Patients in the comparison ( PFX ) group ( n = @ ) received PFX intravenously and per os for @ days and then per os for a further @ months , which is a standard treatment .


Patients in the intervention ( PFX + FC ) group ( n = @ ) received the standard treatment plus @ mg/kg FC for @ days , with a subsequent stepwise dose reduction over time .


As a primary outcome measure , the best corrected visual acuity ( BCVA ) was determined at the initial baseline consultation ( i.e. , before treatment ) , and at @ days and @ months after therapy onset .


Visual field ( VF ) was analyzed using standard automated perimetry at the initial baseline examination and at @ month after therapy onset .


Changes in BCVA and visual field in the PFX and PFX + FC groups were compared and analyzed statistically .


Treatment with FC resulted in a significant improvement in BCVA .


Patients receiving FC in acute NAION were more likely to experience improvement and less likely to have worsened visual acuity ( mean BCVA scores : at baseline , @ ; after @ days and @ months of treatment , @ and @ , respectively ) than PFX patients ( mean BCVA scores : at baseline , @ ; after @ days and @ months of treatment , @ and @ , respectively ; p < @ and @ ) .


The beneficial effect was even more marked @ months after therapy onset .


Remarkably , patients with a baseline BCVA score of > = @ profited significantly by FC treatment ( p < @ and @ ) , whereas those with a baseline BCVA score of < @ did not ( p < @ ) .


PFX did not improve BCVA .


However , VF did not show any significant improvement due to FC therapy .


This is the first prospective randomized intervention trial that demonstrates the distinctive beneficial effects of FC in terms of the visual outcome of patients with NAION compared to standard treatment with only PFX .


FC significantly improves both short - and long-term visual acuity in patients with moderate BCVA impairment due to recent onset of NAION , while VF did not show any significant improvement ; however , PFX did neither enhance BCVA nor VF .


Administration of FC should be seriously considered for the treatment of NAION whenever there are no contraindications .


Currently , there is no consensus concerning the possible beneficial colonic and systemic effects of prebiotic-containing infant formula .


This study assesses whether the feeding of a galactooligosaccharides ( GOS ) - containing infant formula ( @ g/dl of GOS ) and the subsequent feeding of a GOS-containing follow-on formula ( @ g/dl of GOS ) have a prebiotic effect on intestinal microbiota that helps to decrease infections and allergy manifestations in healthy infants during the first year of life .


A multicentre , randomised , double-blind and placebo-controlled trial was carried out on @ healthy term infants enrolled before @ weeks of age and randomly assigned to a formula with or without GOS , until @ months of age .


The incidence of infections and allergy manifestations , the antibiotics prescribed and faecal characteristics were recorded up to @ months of age , while faecal samples were collected up to @ months for the measurement of secretory immunoglobulin A , short-chain fatty acids and microbiota .


A prebiotic effect on the faecal analysis was observed at @ months of life .


The GOS group showed a lower faecal pH ( P = @ ) , a lower decreasing trend in secretory immunoglobulin A ( P = @ ) , lower butyric acid concentration ( P = @ ) and an increase in Bifidobacterium counts ( P = @ ) .


Changes in faecal characteristics involved greater frequency ( P < @ ) and softer consistency ( P < @ ) .


The incidence of infections or allergic manifestations during the first year of life was similar in both groups , with no statistical differences ( P > @ ) .


The feeding of GOS-containing infant formula produced a definite prebiotic effect consisting of changes in faecal composition and microbiota , and in faecal consistency and the frequency of defaecation .


No changes in the incidence of infection or allergic manifestation during the first year of life were observed .


The Canola Oil Multicenter Intervention Trial ( COMIT ) was a randomized controlled crossover study designed to evaluate the effects of five diets that provided different oils and/or oil blends on cardiovascular disease ( CVD ) risk factors in individuals with abdominal obesity .


The present objective is to report preliminary findings on plasma fatty acid profiles in volunteers with abdominal obesity , following the consumption of diets enriched with n-@ , n-@ and n-@ fatty acids .


COMIT was conducted at three clinical sites , Winnipeg , Manitoba , Canada , Qubec City , Qubec , Canada and University Park , Pennsylvania , United States .


Inclusion criteria were at least one of the followings : waist circumference ( @ cm for males and @ cm for females ) , and at least one other criterion : triglycerides @ mmol/L , high density lipoprotein cholesterol < @ mmol/L ( males ) or < @ mmol/L ( females ) , blood pressure @ mmHg ( systolic ) and/or @ mmHg ( diastolic ) , and glucose @ mmol/L .


Weight-maintaining diets that included shakes with one of the dietary oil blends were provided during each of the five @-day dietary phases .


Dietary phases were separated by four-week washout periods .


Treatment oils were canola oil , high oleic canola oil , high oleic canola oil enriched with docosahexaenoic acid ( DHA ) , flax oil and safflower oil blend , and corn oil and safflower oil blend .


A per protocol approach with a mixed model analysis was decided to be appropriate for data analysis .


One hundred and seventy volunteers were randomized and @ completed the study with a dropout rate of @ % .


The mean plasma total DHA concentrations , which were analyzed among all participants as a measure of adherence , increased by more than @ % in the DHA-enriched phase , compared to other phases , demonstrating excellent dietary adherence .


Recruitment and retention strategies were effective in achieving a sufficient number of participants who completed the study protocol to enable sufficient statistical power to resolve small differences in outcome measures .


It is expected that the study will generate important data thereby enhancing our understanding of the effects of n-@ , n-@ , and n-@ fatty acid-containing oils on CVD risks .


UK cancer guidelines recommend patients with colonic obstruction due to suspected malignancy be considered for stenting with a self-expanding metal stent ( SEMS ) .


Considerable variation in practice exists due to a lack of expertise , technical difficulties and other , as yet ill-defined features .


This retrospective multi-centre study aims to determine the outcome following colonic stenting for large bowel obstruction and identify factors associated with successful intervention .


A regional programme of colonic stenting for large bowel obstruction , in five UK centres from @ to @ was evaluated for outcome including technical and clinical success , survival , complications and reoperation .


A SEMS was inserted in @ patients , including @ ( @ % ) for palliation and @ ( @ % ) as a bridge to surgery .


Technical success was achieved in @ ( @ % ) patients , with @ ( @ % ) experiencing a complication or technical failure .


Reoperation was required in @ ( @ % ) patients stented for palliation of colorectal cancer of whom @ ( @ % ) subsequently required a colostomy .


A one-stage primary anastomosis was achieved in @ ( @ % ) of the @ patients undergoing stenting as a bridge to resection .


Technical success did not vary by indication or site of obstruction ( P = @ ) but was higher for operators who had performed more than @ procedures ( OR @ , P = @ ) .


ASA grade @ predicted a worse clinical outcome ( OR @ , P = @ ) .


The through-the-scope ( TTS ) endoscopy technique was more successful than radiological placement alone ( @ % vs @ % , P < @ ) .


Experienced operators using a TTS technique achieved a better outcome for the emergency management of large bowel obstruction .


Older , sicker patients and those with extracolonic and benign strictures fared less well .


The guided outcomes in learned efficiency ( GOLE ) model emphasizes the use of evidence-based resources to understand the diagnosis , treatment , follow-up , and prevention of disease .


We seek to determine whether presentations created using the GOLE model are superior to an unstructured approach in achieving Accreditation Council for Graduate Medical Education ( ACGME ) Core Competencies .


Consenting medical students were randomized to GOLE or control groups to individually research a self-selected clinical topic .


A validated survey instrument was used prepresentation and postpresentation to assess perceived improvement in knowledge .


Subjects completed self-evaluations at enrollment and after presentation of their chosen clinical topic .


Other students , residents , and a faculty member also completed evaluations after each student presentation .


Standard statistical methods ( analysis of variance , @-tailed t test ) were used to determine if a statistically significant difference existed between intervention and control groups .


Self-assessments were similar in the GOLE and control groups .


Externally perceived presentation scores were greater in the GOLE group ( ACGME global P < @ , presentation global P = @ ) , which demonstrated a significant improvement in @ core competencies .


Time spent preparing the presentation and resources utilized did not differ between groups .


The presentations prepared using the GOLE model were rated higher by observers than those prepared using traditional techniques .


The neighborhoods in which children live , play , and eat provide an environmental context that may influence obesity risk and ameliorate or exacerbate health disparities .


The current study examines whether neighborhood characteristics predict obesity in a prospective cohort of girls .


Participants were @ girls ( aged @-@ years at baseline ) , a subset from the Cohort Study of Young Girls ' Nutrition , Environment , and Transitions .


Trained observers completed street audits within a @-mile radius around each girl 's residence .


Four scales ( food and service retail , recreation , walkability , and physical disorder ) were created from @ observed neighborhood features .


BMI was calculated from clinically measured height and weight .


Obesity was defined as BMI-for-age @ % .


Logistic regression models using generalized estimating equations were used to examine neighborhood influences on obesity risk over @ years of follow-up , controlling for race/ethnicity , pubertal status , and baseline BMI .


Fully adjusted models also controlled for household income , parent education , and a census tract measure of neighborhood socioeconomic status .


A @-SD increase on the food and service retail scale was associated with a @ ( @ % confidence interval , @ to @ ; P < @ ) increased odds of being obese .


A @-SD increase in physical disorder was associated with a @ ( @ % confidence interval , @ to @ ; P = @ ) increased odds of being obese .


Other neighborhood scales were not associated with risk for obesity .


Neighborhood food and retail environment and physical disorder around a girl 's home predict risk for obesity across the transition from late childhood to adolescence .


Cervical total disc replacement ( CTDR ) was developed to treat cervical spondylosis , while preserving motion .


While anterior cervical discectomy and fusion ( ACDF ) has been the standard of care for @-level disease , a randomized clinical trial ( RCT ) suggested similar outcomes .


Cost-effectiveness of this intervention has never been elucidated .


To determine the cost-effectiveness of CTDR compared with ACDF .


Data were derived from an RCT that followed up @ patients over @ months .


The original RCT consisted of multi-institutional data including private and academic institutions .


Using linear regression for the current study , health states were constructed based on the stratification of the Neck Disability Index and a visual analog scale .


Data from the @-item Short-Form Health Survey questionnaires were transformed into utilities values using the SF-@D mapping algorithm .


Costs were calculated by extracting Diagnosis-Related Group codes from institutional billing data and then applying @ Medicare reimbursement rates .


The costs of complications and return-to-work data were also calculated .


A Markov model was built to evaluate quality-adjusted life-years ( QALYs ) for both treatment groups .


The model adopted a third-party payer perspective and applied a @ % annual discount rate .


Patients included in the original RCT had to be diagnosed as having radiculopathy or myeloradiculopathy at @ contiguous levels from C@-C@ that was unresponsive to conservative treatment for at least @ weeks or demonstrated progressive symptoms .


Incremental cost-effectiveness ratio of CTDR compared with ACDF .


A strong correlation ( R@ = @ ; P < @ ) was found by projecting a visual analog scale onto the Neck Disability Index .


Cervical total disc replacement had an average of @ QALYs after @ months compared with @ QALYs for ACDF recipients .


Cervical total disc replacement was associated with $ @ greater average cost .


The incremental cost-effectiveness ratio of CTDR compared with ACDF was $ @,@ per QALY at @ years .


Despite varying input parameters in the sensitivity analysis , the incremental cost-effectiveness ratio value stays below the threshold of $ @,@ per QALY in most scenarios ( range , - $ @,@ to $ @,@ per QALY ) .


The incremental cost-effectiveness ratio of CTDR compared with traditional ACDF is lower than the commonly accepted threshold of $ @,@ per QALY .


This remains true with varying input parameters in a robust sensitivity analysis , reaffirming the stability of the model and the sustainability of this intervention .


Dipeptidyl peptidase-@ ( DPP-@ ) inhibitors are a new class of antihyperglycemic drugs that block degradation ofincretin hormones .


To assess the effects oftreatment with DPP-@ inhibitors on glucoregulation and body weight in obese patients with type @ diabetes mellitus .


The study included @ females and @ males with type @ diabetes ( n = @ ) , BMI = @ + / - @,@ kg/m@ , mean age @ + / - @,@ years .


The patients have been thoroughly evaluated before treatment , and @ months after treatment with DPP-@ inhibitor ( sitagliptin ) in combination with metformin .


After @ months of treatment with DPP-@ inhibitors in combination with metformin HbAlc ( -@,@ % ) .


, FBG ( -@ mmol/L ) and PBG ( -@ mmol/L ) significantly reduced ( p = @ ) .


Mean body weight also significantly reduced ( -@ % ; p = @ ) .


Reduction of mean fasting insulin was @ mIU/L or @ % ( p = @ ) .


Mean HOMA-IR change was -@ ( p = @ ) .


Also there was significant decreasing of systolic blood pressure ( p = @ ) , cholesterol ( p = @ ) , triglycerides ( p = @ ) , LDL ( p = @ ) and increasing of HDL ( p = @ ) .


Hypoglycaemia was not registered in any of the patients .


These results show that in obese patients with type @ diabetes , DPP-@ inhibitors treatment in combination with metformin was associated with improvements in glycaemic control , and a reduction in body weight .


This is a report of a clinical trial on the therapeutic efficacy and safety of combined aliskiren and losartan ( an angiotensin II receptor blocker ( ARB ) ) versus aliskiren alone and ARB alone in non-diabetic chronic kidney disease ( CKD ) over a @-year period .


This was a randomised trial in @ patients with non-diabetic CKD comparing aliskiren ( @ mg/day ) ( n = @ ) versus losartan ( @ mg/day ) ( n = @ ) and the third group aliskiren ( @ mg/day ) combined with losartan ( @ mg/day ) ( n = @ ) .


The trial utilised primary renal end points of eGFR < @ ml/min or end-stage renal failure .


All three groups had significant reduction of proteinuria ( p < @ for all ) .


The changes in eGFR , total urinary protein from baseline to each year were not significantly different between the three therapeutic groups .


This study in non-diabetic CKD patients showed that combination therapy with aliskiren and ARB was as efficacious as aliskiren alone and ARB alone .


There was one patient who developed a non-fatal stroke in the combined aliskiren and ARB group while the other two groups had none .


Very low density lipoprotein triglyceride ( VLDL-TG ) and free fatty acids ( FFA ) constitute a substantial proportion of human energy supply both at rest and during exercise .


Exercise acutely decreases VLDL-TG concentration , and VLDL-TG clearance is increased after an exercise bout .


However , the effects of long-term training are not clear .


The aim was to investigate long-term effects of training by direct assessments of VLDL-TG and palmitate kinetics and oxidation in healthy lean men ( n = @ ) at rest , before and after a @-week training program , compared with a non-training control group ( n = @ ) .


VLDL-TG kinetics were assessed by a primed constant infusion of -LSB- @-@C -RSB- VLDL-TG , and VLDL-TG oxidation by specific activity ( @CO@ ) in expired air .


The metabolic study days were placed @-@h after the last exercise bout .


Palmitate kinetics and oxidation were assessed by a @h constant infusion of -LSB- @,@ - ( @ ) H -RSB- palmitate .


In the training group ( n = @ ) , maximal oxygen uptake increased significantly by @ % ( P < @ ) , and the insulin sensitivity ( assessed by the hyperinsulinemic-euglycemic clamp ) improved significantly ( P < @ ) .


Despite these metabolic improvements , no changes were observed in VLDL-TG secretion , clearance , or oxidation or in palmitate kinetics .


We conclude that @ weeks of exercise training did not induce changes in VLDL-TG and palmitate kinetics in healthy lean men .


To explore the effect of structural family therapy ( SFT ) , which refers to the application of the theory and technology of SFT for improving the internal family environment of pediatric patients through reorganization of the family roles , tasks , and boundaries , on the family structure and function in children with hematological tumors .


Forty children with hematological tumors were randomly divided into SFT and control groups ( n = @ each ) .


The control group received conventional chemotherapy .


The SFT group received SFT by a trained therapist in addition to conventional chemotherapy ; the family of each patient received SFT four times ( once every two weeks ) .


Both groups were assessed by the Family Assessment Device ( FAD ) and Family Environment Scale-Chinese Version ( FES-CV ) on admission and one month after the end of SFT .


After treatment , the SFT group showed significant decreases in all factor scores of FAD ( P < @ ) ; the SFT group had significantly lower scores of problem solving , communication , roles , affective involvement , behavior control , and general functioning than the control group ( P < @ ) .


In addition , the SFT group had significantly increased FES-CV scores of cohesion , emotional expression , intellectual-cultural orientation , and active-recreational orientation and a significantly decreased score of conflict after treatment ( P < @ ) , and the SFT group was significantly superior to the control group in terms of these items ( P < @ ) .


SFT could promote beneficial family changes in children with hematological tumors by improving the family function and internal environment , which would increase the long-term chemotherapy compliance of these children and their parents .


The aim of this study was to assess pain associated with subcutaneous injection into the abdomen and thigh of different combinations of injection speeds and volumes .


The study was a single-centre , one-visit , double-blinded , randomized controlled trial in @ adults with type @ or type @ diabetes receiving daily injections of insulin or glucagon-like peptide-@ ( GLP-@ ) agonists .


Participants received @ subcutaneous injections ( @ in abdomen , @ in thigh ) of saline at different injection speeds ( @ , @ and @ l/s ) , with different volumes ( @ , @ , @ and @ l ) , and two needle insertions without any injection .


Pain was evaluated on a @-mm visual analogue scale ( VAS ) ( @ mm no pain , @ mm worst pain ) and on a yes/no scale for pain acceptability .


Injection speed had no impact on injection pain ( p = @ ) .


Injection of larger volumes caused significantly more pain -LSB- VAS least square mean differences @ vs. @ l , @ @ mm ( @ % confidence interval - CI ; @-@ @ ; p < @ ) ; @ vs. @ l , @ mm ( @-@ @ ; p < @ ) ; @ vs. @ l , @ mm ( @-@ @ ; p = @ ) and @ vs. @ l , @ mm ( @-@ @ ; p = @ ) -RSB- .


Significantly more pain occurred in the thigh versus the abdomen -LSB- @ mm ( @-@ @ ; p < @ ) -RSB- .


Injection speed had no effect on injection pain , whereas higher injection volumes caused more pain .


The results of this study may be of value for guiding patients to use the appropriate injection site and technique to reduce their injection pain .


Furthermore , these findings may have important implications for the development of new injection devices and drug formulations for clinical practice .


To compare with antibiotics with methicillin-resistant microbial coverage in a prospective fashion .


Current antibiotic prophylaxis for vascular procedures includes a first generation cephalosporin .


No changes in recommendations have occurred despite changes in reports of incidence of MRSA related surgical site infections .


Does supplemental anti-MRSA prophylactic coverage provide a significant reduction in Gram-positive or MRSA infections ?


Single center prospective double blinded randomized study of patients undergoing lower extremity vascular procedures from @ to @ .


One hundred seventy-eight ( @ ) patients were evaluated at @ days for surgical site infection .


Infections were categorized as early infections less than @ days of the index procedure and late after @ days .


Early vascular surgical site infection occurred in @ ( @ % ) of patients in the Vancomycin arm , and @ ( @ % ) in the Daptomycin arm ( P = @ ) .


Gram-positive related infections and MRSA infections occurred in @ ( @ % ) / @ ( @ % ) of Vancomycin patients and @ ( @ % ) / @ ( @ % ) of Daptomycin patients , respectively ( P < @ and P = @ ) .


Readmissions related to surgical site infections occurred in @ ( @ % ) in the Vancomycin group and @ ( @ % ) in the Daptomycin group ( P = @ ) .


Patients undergoing operative exploration occurred in @ ( @ % ) in the Vancomycin group and @ ( @ % ) of the Daptomycin group ( P = @ ) .


Late infections were reported in @ patients , @ of which were in the combined Daptomycin group .


Median hospital charges related to readmissions due to a surgical site infection was $ @,@ in the combination Vancomycin arm and $ @,@ in the combination Daptomycin group ; however , no statistical significance was appreciated ( P = @ ) .


Vancomycin supplemental prophylaxis seems to reduce the incidence of Gram-positive infection compared with adding supplemental Daptomycin prophylaxis .


The Incidence of MRSA-related surgical site infections is low with the addition of either anti-MRSA agents compared with historical incidence of MRSA-related infection .


The management of patients with angiographically intermediate coronary lesions is a major clinical issue .


Fractional flow reserve provides validated functional insights while optical coherence tomography provides high resolution anatomic imaging .


Both techniques may be applied to guide management in case of angiographically intermediate coronary lesions .


Moreover , these techniques may be used to optimize the result of percutaneous coronary intervention .


We aim to compare the clinical and economic impact of fractional flow reserve versus optical coherence tomography guidance in patients with angiographically intermediate coronary lesions .


Patients with at least one angiographically intermediate coronary lesion will be randomized ( ratio @:@ ) to fractional flow reserve or optical coherence tomography guidance .


In the fractional flow reserve arm , percutaneous coronary intervention will be performed if fractional flow reserve value is @ , and will be conducted with the aim of achieving a post-percutaneous coronary intervention fractional flow reserve target value of @ .


In the optical coherence tomography arm , percutaneous coronary intervention will be performed if percentage of area stenosis ( AS % ) is @ % or @ to @ % with minimal lumen area < @ mm@ , or if a major plaque ulceration is detected .


In case of percutaneous coronary intervention , optical coherence tomography will guide the procedure in order to minimize under-expansion , malapposition , and edge dissections.Cost load and clinical outcome will be prospectively assessed at one and thirteen months .


The assessed clinical outcome measures will be : major cardiovascular events and occurrence of significant angina defined as a Seattle Angina Questionnaire score < @ in the angina frequency scale .


The FORZA trial will provide useful guidance for the management of patients with coronary artery disease by prospectively assessing the use of two techniques representing the gold standard for functional and anatomical definition of coronary plaques .


The aim of this study was to evaluate the prognostic value of MSI-H and p@ overexpression in metastatic colorectal cancer ( mCRC ) treated with oxaliplatin and fluoropyrimidine-based first line chemotherapy .


Tumour samples were retrospectively obtained from @ patients from a prospective randomised phase III trial of the AIO colorectal study group , comparing CAPOX and FUFOX in mCRC .


Immunohistochemistry of p@ and MMR proteins as well as microsatellite analysis were performed .


The incidence of MSI-H and p@ overexpression was @ % and @ % , respectively .


MSI-H status was not correlated with ORR , PFS and OS .


We observed a trend to lower DCR for MSI-H tumours ( @ % vs. @ % , p = @ ) .


p@ overexpression was not correlated with DCR , ORR and PFS .


The median OS of patients with tumors with p@ overexpression was significantly longer compared to tumors withhout p@ overexpression ( @ vs. @ months ; p = @ ) .


The post-progression survival ( PPS ) of p@-positive patients undergoing @nd and/or @rd line chemotherapy with irinotecan and/or cetuximab was significantly longer compared to p@-negative patients .


MSI-H tumours tend to have lower disease control rates when treated with an oxaliplatin/fluoropyrmidin combination .


mCRC patients with p@ overexpression undergoing an irinotecan containing second - or third-line chemotherapy after oxaliplatin failure have a significantly longer post-progression survival compared to patients without p@ overexpression .


To validate the clinical impact of p@ in patients with mCRC treated with irinotecan - and/or cetuximab further studies are needed .


New drug regimens of greater efficacy and shorter duration are needed for tuberculosis ( TB ) treatment .


The identification of accurate , quantitative , non-culture based markers of treatment response would improve the efficiency of Phase @ TB drug testing .


In an unbiased biomarker discovery approach , we applied a highly multiplexed , aptamer-based , proteomic technology to analyze serum samples collected at baseline and after @ weeks of treatment from @ patients with pulmonary TB from Kampala , Uganda enrolled in a Centers for Disease Control and Prevention ( CDC ) TB Trials Consortium Phase @B treatment trial .


We identified protein expression differences associated with @-week culture status , including Coagulation Factor V , SAA , XPNPEP@ , PSME@ , IL-@ R , HSP@ , Galectin-@ , @-Antiplasmin , ECM@ , YES , IGFBP-@ , CATZ , BGN , LYNB , and IL-@ .


Markers noted to have differential changes between responders and slow-responders included nectin-like protein @ , EphA@ ( Ephrin type-A receptor @ ) , gp@ , CNDP@ , TGF-b RIII , MRC@ , ADAM@ , and CDON .


A logistic regression model combining markers associated with @-week culture status revealed an ROC curve with AUC = @ , sensitivity = @ and specificity = @ .


Additional markers showed differential changes between responders and slow-responders ( nectin-like protein ) , or correlated with time-to-culture-conversion ( KLRK@ ) .


Serum proteins involved in the coagulation cascade , neutrophil activity , immunity , inflammation , and tissue remodeling were found to be associated with TB treatment response .


A quantitative , non-culture based , five-marker signature predictive of @-week culture status was identified in this pilot study .


The ability of polymer-modified coils to promote stable aneurysm occlusion after endovascular treatment is not well-documented .


Angiographic aneurysm recurrence is widely used as a surrogate for treatment failure , but studies documenting the correlation of angiographic recurrence with clinical failure are limited .


This trial compares the effectiveness of Matrix ( @ ) polyglycolic/polylactic acid biopolymer-modified coils with bare metal coils and correlates the angiographic findings with clinical failure ( ie , target aneurysm recurrence ) , a composite end point that includes any incident of posttreatment aneurysm rupture , retreatment , or unexplained death .


This was a multicenter randomized noninferiority trial with blinded end point adjudication .


We enrolled @ patients , divided between Matrix ( @ ) and bare metal coil groups .


The primary outcome was target aneurysm recurrence at @ @ months .


At @ days , at least @ target aneurysm recurrence event had occurred in @ % of patients treated with bare metal coils and @ % of Matrix ( @ ) ( P = @ , log-rank test ) patients ; @ % of target aneurysm recurrence events were re-interventions for aneurysms that had not bled after treatment , and @ % of target aneurysm recurrence events resulted from hemorrhage or rehemorrhage , with or without retreatment .


Symptomatic re-intervention occurred in only @ ( @ % ) patients .


At @ days , @ % of patients with unruptured aneurysms and @ % of those with ruptured aneurysms were independent ( mRS @ ) .


Target aneurysm recurrence was associated with incomplete initial angiographic aneurysm obliteration , presentation with rupture , and a larger aneurysmal dome and neck size .


Tested Matrix ( @ ) coils were not inferior to bare metal coils .


Endovascular coiling of intracranial aneurysms was safe , and the rate of technical success was high .


Target aneurysm recurrence is a promising clinical outcome measure that correlates well with established angiographic measurements .


Regular aerobic exercise in patients with cystic fibrosis ( CF ) improves aerobic conditioning and delays disease progression , resulting in better quality of life .


The purpose of this study was to evaluate the effect of an aerobic exercise program based on verbal and written guidelines on maximum exercise capacity using a cardiopulmonary exercise test , quality of life , and the self-reported aerobic exercise practice of children and adolescents with CF.


This randomized controlled trial followed guidelines for physical exercise in a CF center .


Subjects were assigned to @ groups : intervention ( group @ ) , with @ subjects ; and control ( group @ ) , also with @ subjects .


Data were collected from October @ to October @ , and the study population comprised @-@-y-old children and adolescents with CF. The intervention consisted of handing out a manual with guidelines for aerobic physical exercises and reinforcing recommendations in telephone calls every @ weeks .


Thirty-four subjects were included in the study , @ of whom were boys ( @ % ) .


The groups were similar at baseline .


In group @ , @ subjects ( @ % ) reported practicing physical exercises regularly .


The mean age was @ @ y , the mean percent-of-predicted FEV@ was @ @ % , and the mean peak oxygen uptake ( VO@ ) relative to body mass was @ @ mL/kg/min .


The mean age was @ @ y , the mean percent-of-predicted FEV@ was @ @ % , and the mean peak VO@ was @ @ mL/kg/min .


In group @ , there was a significant increase in physical exercise practice as reported by subjects after @ months of intervention compared with group @ ( P = @ ) .


No statistically significant differences were found for the other variables .


Verbal and written guidelines for aerobic exercise , together with supervision over the telephone , had a positive impact on the self-reported regular physical exercise practice of children and adolescents .


However , no improvement was found in lung function and maximum exercise capacity or domains of the quality of life questionnaire .


The stepped care program Bridging Intervention in Anesthesiology ( BRIA ) aims at motivating and supporting surgical patients with comorbid mental disorders to engage in psychosocial mental healthcare options .


This study examined the efficacy of BRIA .


This randomized , parallel-group , open-label , controlled trial was conducted in the preoperative anesthesiological assessment clinics and surgical wards of a large university hospital in Germany .


A total of @ surgical patients with comorbid mental disorders were randomized by using the computer-generated lists to one of two intervention groups : BRIA psychotherapy sessions up to @ months postoperatively ( BRIA ) versus no psychotherapy/computerized brief written advice ( BWA ) only .


Primary outcome was participation in psychosocial mental healthcare options at month @ .


Secondary outcome was change of self-reported general psychological distress ( Global Severity Index of the Brief Symptom Inventory ) between baseline and month @ .


At @-month follow-up , the rate of patients who engaged in psychosocial mental healthcare options was @ % ( @ of @ ) in BRIA compared with @ % ( @ of @ ) in BWA ( P = @ ) .


Number needed to treat and relative risk reduction were @ ( @ % CI , @ to @ ) and @ ( @ to @ ) , respectively .


In BRIA , Global Severity Index decreased between baseline and month @ ( P < @ ) , whereas it did not change significantly in BWA ( P = @ ) .


Among surgical patients with comorbid mental disorders , BRIA results in an increased engagement in subsequent therapy options and a decrease of general psychological distress .


These data suggest that it is reasonable to integrate innovative psychotherapy programs into the context of interdisciplinary surgical care .


This study investigated the effects of fatty fish on sleep , daily functioning and biomarkers such as heart rate variability ( HRV ) , vitamin D status ( serum @-hydroxyvitamin D ( @OHD ) , and eicosapentaenoic acid ( EPA , @:@ n-@ ) + docosahexaenoic acid ( DHA , @:@ n-@ ) in red blood cells .


Moreover the relationship among sleep , daily functioning , HRV , vitamin D status , and levels of EPA+DHA was investigated .


Ninety-five male forensic patients from a secure forensic inpatient facility in the USA were randomly assigned into a Fish or a Control group .


The Fish group received Atlantic salmon three times per week from September to February , and the Control group was provided an alternative meal ( e.g. , chicken , pork , beef ) , but with the same nutritional value as their habitual diet , three times per week during the same period .


Sleep ( sleep latency , sleep efficiency , actual sleep time , and actual wake time ) , self-perceived sleep quality and daily functioning , as well as vitamin D status , EPA+DHA , and HRV , were assessed pre - and post-intervention period .


There was a significant increase in sleep latency from pre - to post-test in the Control group .


The Fish group reported better daily functioning than the Control group during post-test .


Fish consumption throughout the wintertime had also an effect on resting HRV and EPA+DHA , but not on vitamin D status .


However , at post-test , the vitamin D status in the Fish group was still closer to the level regarded as optimal compared to the Control group .


Vitamin D status correlated negatively with actual wake time and positively with sleep efficiency during pre-test , as well as positively with daily functioning and sleep quality during post-test .


Finally , HRV correlated negatively with sleep latency and positively with daily functioning .


Fish consumption seemed to have a positive impact on sleep in general and also on daily functioning , which may be related to vitamin D status and HRV .


Neurocysticercosis ( NCC ) is a major cause of seizures and epilepsy in endemic countries .


Antiparasitic treatment of brain cysts leads to seizures due to the host 's inflammatory reaction , requiring concomitant steroids .


We hypothesized that increased steroid dosing will reduce treatment-associated seizures .


Open-label randomized trial comparing @ mg/day dexamethasone for @ days ( conventional ) with @ mg/day for @ days followed by a @-week taper ( enhanced ) in patients with NCC receiving albendazole .


Follow-up included active seizure surveillance and brain imaging .


Study outcomes were seizure days and patients with seizures , both measured in days @-@ .


Additional analyses compared days @-@ , @-@ , @-@ , @-@ , @-@ , and @-@ .


Thirty-two individuals were randomized into each study arm ; two did not complete follow-up .


From days @ to @ , @ partial and @ generalized seizure days occurred in @ individuals , nonsignificantly fewer in the enhanced arm ( @ vs. @ , p = @ ) .


The numbers of patients with seizures in this period showed similar nonsignificant differences .


In the enhanced steroid arm there were significantly fewer days and individuals with seizures during antiparasitic treatment ( days @-@ : @ vs. @ , p = @ , and @ vs. @ , p = @ , number needed to treat -LSB- NNT -RSB- @ , relative risk -LSB- RR -RSB- @ , @ % confidence interval -LSB- CI -RSB- @-@ @ ) and early after dexamethasone cessation ( days @-@ : @ vs. @ , p = @ , and @ vs. @ , p = @ , NNT @ , RR @ , @ % CI @-@ @ ) but not after day @ .


There were no significant differences in antiparasitic efficacy or relevant adverse events .


Increased dexamethasone dosing results in fewer seizures for the first @ days during and early after antiparasitic treatment for viable parenchymal NCC but not during the first @-@ days , which was the primary predetermined time of analysis .


A strategy using mechanical chest compressions might improve the poor outcome in out-of-hospital cardiac arrest , but such a strategy has not been tested in large clinical trials .


To determine whether administering mechanical chest compressions with defibrillation during ongoing compressions ( mechanical CPR ) , compared with manual cardiopulmonary resuscitation ( manual CPR ) , according to guidelines , would improve @-hour survival .


Multicenter randomized clinical trial of @ patients with out-of-hospital cardiac arrest conducted between January @ and February @ in @ Swedish , @ British , and @ Dutch ambulance services and their referring hospitals .


Duration of follow-up was @ months .


Patients were randomized to receive either mechanical chest compressions ( LUCAS Chest Compression System , Physio-Control/Jolife AB ) combined with defibrillation during ongoing compressions ( n = @ ) or to manual CPR according to guidelines ( n = @ ) .


Four-hour survival , with secondary end points of survival up to @ months with good neurological outcome using the Cerebral Performance Category ( CPC ) score .


A CPC score of @ or @ was classified as a good outcome .


Four-hour survival was achieved in @ patients ( @ % ) with mechanical CPR and @ ( @ % ) with manual CPR ( risk difference , -@ % ; @ % CI , -@ % to @ % ; P > @ ) .


Survival with a CPC score of @ or @ occurred in @ ( @ % ) vs @ ( @ % ) ( risk difference , @ % ; @ % CI , -@ % to @ % ) at intensive care unit discharge , in @ ( @ % ) vs @ ( @ % ) ( risk difference , @ % ; @ % CI , -@ % to @ % ) at hospital discharge , in @ ( @ % ) vs @ ( @ % ) ( risk difference , @ % ; @ % CI , -@ % to @ % ) at @ month , and in @ ( @ % ) vs @ ( @ % ) ( risk difference , @ % ; @ % CI , -@ % to @ % ) at @ months with mechanical CPR and manual CPR , respectively .


Among patients surviving at @ months , @ % in the mechanical CPR group and @ % in the manual CPR group had CPC scores of @ or @ .


Among adults with out-of-hospital cardiac arrest , there was no significant difference in @-hour survival between patients treated with the mechanical CPR algorithm or those treated with guideline-adherent manual CPR .


The vast majority of survivors in both groups had good neurological outcomes by @ months .


In clinical practice , mechanical CPR using the presented algorithm did not result in improved effectiveness compared with manual CPR .


Parkinson 's disease ( PD ) has a progressive course and is characterized by the degeneration of dopaminergic neurons .


Although no neuroprotective treatments for PD have been found to date , the endocannabinoid system has emerged as a promising target .


From a sample of @ patients consecutively evaluated in a specialized movement disorders outpatient clinic , we selected @ PD patients without dementia or comorbid psychiatric conditions .


Participants were assigned to three groups of seven subjects each who were treated with placebo , cannabidiol ( CBD ) @ mg/day or CBD @ mg/day .


One week before the trial and in the last week of treatment participants were assessed in respect to ( i ) motor and general symptoms score ( UPDRS ) ; ( ii ) well-being and quality of life ( PDQ-@ ) ; and ( iii ) possible neuroprotective effects ( BDNF and H ( @ ) - MRS ) .


We found no statistically significant differences in UPDRS scores , plasma BDNF levels or H ( @ ) - MRS measures .


However , the groups treated with placebo and CBD @ mg/day had significantly different mean total scores in the PDQ-@ ( p = @ ) .


Our findings point to a possible effect of CBD in improving quality of life measures in PD patients with no psychiatric comorbidities ; however , studies with larger samples and specific objectives are required before definitive conclusions can be drawn .


Gait training for patients with hemiparesis is carried out independently overground or on a treadmill .


Several studies have shown differences in hemiparetic gait parameters during overground versus treadmill walking .


However , few studies have compared the effects of these @ gait training conditions on gait parameters , and no study has compared the short-term effects of these techniques on all biomechanical gait parameters .


To determine whether a gait training session performed overground or on a treadmill induces specific short-term effects on biomechanical gait parameters in patients with hemiparesis .


Twenty-six subjects with hemiparesis were randomly assigned to a single session of either overground or treadmill gait training .


The short-term effects on spatiotemporal , kinematic , and kinetic gait parameters were assessed using gait analysis before and immediately after the training and after a @-minute rest .


Speed , cadence , percentage of single support phase , peak knee extension , peak propulsion , and braking on the paretic side were significantly increased after the gait training session .


However , there were no specific changes dependent on the type of gait training performed ( overground or on a treadmill ) .


A gait training session performed by subjects with hemiparesis overground or on a treadmill did not induce specific short-term effects on biomechanical gait parameters .


The increase in gait velocity that followed a gait training session seemed to reflect specific modifications of the paretic lower limb and adaptation of the nonparetic lower limb .


Virtual visits through web-based video conferencing can increase access to specialty care for individuals with Huntington disease ( HD ) and facilitate research participation .


To determine the feasibility of conducting virtual visits directly into the homes of individuals with HD , to assess the reliability of conducting remote versus in-person motor assessments , and to determine the test-retest reliability of conducting motor assessments remotely .


Individuals with mild to moderate HD underwent baseline in-person clinic assessments and completed a HD care survey .


Participants were randomized to receive three virtual visits from one of two physicians over four months that included a modified Unified Huntington 's Disease Rating Scale motor examination ( excluding rigidity and balance assessments ) via web-based video conferencing .


Intraclass coefficients ( ICC ) were calculated to determine the level of agreement between remote and in-person assessments .


Participants also completed a survey on their interest in telemedicine .


Thirteen individuals underwent baseline assessments , eleven ( @ % ) participants completed at least one virtual visit , and @ ( @ % ) of @ total virtual visits were completed .


Remote motor scores demonstrated good reliability ( ICC = @ ; n = @ ) compared to in-person motor scores .


Test-retest reliability of motor scores conducted remotely was excellent ( ICC = @ ; n = @ ) .


Participants expressed moderate future interest in using virtual visits to participate in research and to receive care .


In this pilot study , virtual visits into the home were feasible and reliable for conducting motor assessments in HD .


Larger scale studies need to confirm and generalize these findings to a broader population of participants .


To improve adolescent notification of positive sexually transmitted infection ( STI ) tests using mobile phone technology and STI information cards .


A randomized intervention among @ - to @-year olds in a pediatric emergency department ( PED ) .


A @ @ factorial design with replication was used to evaluate the effectiveness of six combinations of two factors on the proportion of STI-positive adolescents notified within @days of testing .


Independent factors included method of notification ( call , text message , or call + text message ) and provision of an STI information card with or without a phone number to obtain results .


Covariates for logistic regression included age , empiric STI treatment , days until first attempted notification , and documentation of confidential phone number .


Approximately half of the @ females and @ males enrolled were @years of age .


Texting only or type of card was not significantly associated with patient notification rates , and there was no significant interaction between card and notification method .


For females , successful notification was significantly greater for call + text message ( odds ratio , @ ; @ % confidence interval , @-@ @ ) , and documenting a confidential phone number was independently associated with successful notification ( odds ratio , @ ; @ % confidence interval , @-@ @ ) .


We found no significant predictors of successful notification for males .


Of patients with a documented confidential phone number who received a call + text message , @ % of females and @ % of males were successfully notified .


Obtaining a confidential phone number and using call + text message improved STI notification rates among female but not male adolescents in a pediatric emergency department .


To investigate biochemically whether total intravenous anesthesia ( TIVA ) using propofol creates a risk for Propofol Infusion Syndrome ( PRIS ) .


Forty patients scheduled for thyroid gland surgery were randomly assigned into Group T or C and premedicated @ min before operation .


Group T received remifentanyl hydrochloride , propofol infusion following anesthesia induction with propofol , vecuronium bromide and intubation .


Group C received remifentanyl hydrochloride infusion , @-@ @ MAC desflurane inhalation following anesthesia induction with thiopental , vecuronium bromide and intubation .


Patients were respired @ % O@-air mixture .


Blood gas , potassium , lactic acid , CK-MB , myoglobin , troponin I , total carnitine , triglyceride , creatinine concentrations were determined before operation , at intraoperative hour-@ , postoperative hour-@ .


There were no significant differences between groups in potassium , lactic acid CK-MB , myoglobin , total carnitine or creatinine levels .


Triglyceride level at intraoperative hour-@ increased in Group T , decreased at postoperative hour-@ .


Troponin I was higher in Group C than Group T at intraoperative hour-@ ( p < @ ) .


No asystole , bradycardia , arrhythmia , hypotension or change in urine color was detected .


The present biochemical findings suggest that TIVA using propofol is safe .


Traditional rotation-based models of placebo nausea are limited because they do not have vehicle settings and are tied to their context .


The present study introduces a new model for examining placebo-induced nausea in the laboratory that overcomes these limitations , namely , Galvanic Vestibular Stimulation ( GVS ) .


GVS stimulates the vestibular system to cause nausea through sensory mismatch with visual cues and importantly has a non-nauseating placebo setting .


Using this , we tested whether conditioning could elicit placebo nausea when participants were later exposed to placebo stimulation as well as whether this placebo nausea was generalised across contexts -- something that is extremely difficult to test with rotation-based models of placebo nausea .


Thirty healthy undergraduate students were randomised to receive either placebo GVS ( controls ) or active GVS during training ( Context-Consistent and Context-Change ) .


On test , all groups received placebo GVS .


The controls and Context-Consistent groups were tested in the same context as training , whereas the Context-Change group was tested in a new context .


Participants conditioned with nausea during training had significantly higher nausea symptom ratings after placebo stimulation on test than those given no conditioning .


This placebo-induced nausea also generalised to a novel test context with no differences observed between the Context-Change and Context-Consistent groups .


GVS provides a new model of placebo-induced nausea that overcomes limitations to traditional rotation-based paradigms .


Future studies should use this device to explore the effect of instructions and conditioning on the development of placebo nausea and to assess the efficacy of conditioning-based interventions for clinical use .


Contrasting results have been reported regarding the influence of the use of adhesive on biofilm formation .


The purpose of this study was to evaluate the influence of the use of adhesive on the formation of biofilm on the internal surface of complete dentures and the palatal mucosa of denture wearers .


Thirty participants with well-fitting complete dentures were randomly divided according to the experimental design : protocol @ , adhesive use during the first @ days , followed by no use of adhesive over the next @ days ; protocol @ , no use of adhesives during the first @ days , followed by adhesive use over the next @ days .


After each period , material from the mucosa and intaglio of the maxillary dentures was collected .


Replicate aliquots were plated onto Petri dishes containing selective media for Candida spp , Streptococcus mutans , and a nonselective culture medium .


Colony-forming units were expressed as log ( CFU +@ ) / mL .


In addition , the internal surfaces of the maxillary and mandibular complete dentures were stained and photographed .


From the photographs , the total internal surface and the surface stained with biofilm were quantified ( software ImageTool @ ) , and the percentage of the biofilm-covered area ( % ) on the maxillary and mandibular dentures was calculated and compared with @-way ANOVA .


For the nonselective culture medium , data were compared with the paired-sample t test , and the Wilcoxon signed rank test was performed to compare the colony counts of Candida spp and Streptococcus mutans ( = @ ) .


Similar colony counts were found with or without the use of adhesive for the mucosa and internal surfaces of maxillary dentures , irrespective of the culture medium ( P > @ ) .


The area of dentures covered with biofilm was influenced by the use of adhesive ( P = @ ) , regardless of the type of denture ( P = @ ) .


The use of adhesive did not alter the colony counts of microorganisms from the palatal mucosa and maxillary dentures of complete denture wearers during the @-day period , but it did influence the area covered with biofilm on the internal surfaces of the complete dentures .


To compare the efficacy and tolerability of a low-volume ( @-L ) polyethylene glycol ( PEG ) regimen for colonoscopy compared to single ( @-L ) or split-dose ( @-L +@ - L ) regimens .


In-hospital patients who were candidates for colonoscopy were randomly assigned to : group @ single-dose ( PEG @L the day before the study , n = @ ) ; group @ : split-dose ( @L the day before and @L on the day of the procedure , n = @ ) ; and group @ : low-volume @-L PEG solution ( the day of the procedure , n = @ ) .


A blinded evaluation of the quality of colonic preparation was assessed by the Boston bowel preparation scale .


Satisfactory bowel preparation of the right colon was more frequently reported for group @ than for group @ ( @ % vs @ % , P = @ ) , in the transverse colon it was @ % versus @ % ( P = @ ) , and on the left side of the colon it was @ % versus @ % ( P = @ ) .


Compared to group @ , satisfactory bowel preparation in group @ was similar in the transverse colon and left colon .


Nausea , vomiting , and abdominal discomfort were less frequent in patients of group @ .


Patients in group @ had fewer sleep disorders and fewer hours of sleep loss compared to patients in the other groups .


Preparation with @L caused less abdominal discomfort and fewer sleep disorders .


The split dose had a better quality of preparation in the right colon .


Both preparations were clearly better than the @-L preparation .


Traditional Chinese medicine ( TCM ) is considered an important complementary therapy with beneficial effects for cancer patients .


Elderly patients with non-small-cell lung cancer ( NSCLC ) are a complex patient group with increasing co-morbidity and shrinking physiological reserve , and may derive substantial benefit from the supportive aspects of TCM .


Researchers from Shanghai Longhua Hospital found that qi and yin deficiency is a common syndrome in patients with stage III or IV lung cancer .


This project was designed to study the combination of single-agent chemotherapy with TCM methods of benefiting qi and yin in elderly patients with advanced NSCLC .


This is a double-blind controlled , multi-center , and prospective study with randomly selected participants from elderly NSCLC patients in China .


Seventy-six patients who meet the inclusion criteria will be allocated into two groups , which will receive treatments of @-week single-agent chemotherapy with TCM or placebo for four cycles .


Progression-free survival ( PFS ) is the primary end point , and the secondary end points are overall survival , objective response rate , time-to-progression , and quality of life ( EORTC QLQ-LC@ , and TCM syndrome score ) .


Meanwhile , other end points such as toxicity , side effects and safety of the treatments will be assessed .


Results from this study may provide evidence on the effectiveness , and parameters for the usage of single-agent chemotherapy combined with or without TCM on PFS of elderly patients with NSCLC .


Coadministration of a bacterial adjuvant with oral immunotherapy ( OIT ) has been suggested as a potential treatment for food allergy .


To evaluate a combined therapy comprising a probiotic together with peanut OIT .


We performed a double-blind , placebo-controlled randomized trial of the probiotic Lactobacillus rhamnosus CGMCC @ and peanut OIT ( probiotic and peanut oral immunotherapy -LSB- PPOIT -RSB- ) in children ( @-@ years ) with peanut allergy .


The primary outcome was induction of sustained unresponsiveness @ to @ weeks after discontinuation of treatment ( referred to as possible sustained unresponsiveness ) .


Secondary outcomes were desensitization , peanut skin prick test , and specific IgE and specific IgG@ measurements .


Sixty-two children were randomized and stratified by age ( @ and > @ years ) and peanut skin test wheal size ( @ and > @ mm ) ; @ reached the trial 's end .


Baseline demographics were similar across groups .


Possible sustained unresponsiveness was achieved in @ % receiving PPOIT and @ % receiving placebo ( P < @ ) .


Nine children need to be treated for @ to achieve sustained unresponsiveness ( number needed to treat , @ ; @ % CI , @-@ @ ) .


Of the subjects , @ % receiving PPOIT and @ % receiving placebo were desensitized ( P < @ ) .


PPOIT was associated with reduced peanut skin prick test responses and peanut-specific IgE levels and increased peanut-specific IgG@ levels ( all P < @ ) .


PPOIT-treated participants reported a greater number of adverse events , mostly with maintenance home dosing .


This is the first randomized placebo-controlled trial evaluating the novel coadministration of a probiotic and peanut OIT and assessing sustained unresponsiveness in children with peanut allergy .


PPOIT was effective in inducing possible sustained unresponsiveness and immune changes that suggest modulation of the peanut-specific immune response .


Further work is required to confirm sustained unresponsiveness after a longer period of secondary peanut elimination and to clarify the relative contributions of probiotics versus OIT .


Atopic dermatitis ( AD ) is a common inflammatory skin disease with a global prevalence ranging from @ % to @ % .


Patients with AD have an increased risk for complications after viral infection ( eg , herpes simplex virus ) , and vaccination of patients with AD with live vaccinia virus is contraindicated because of a heightened risk of eczema vaccinatum , a rare but potentially lethal complication associated with smallpox vaccination .


We sought to develop a better understanding of immunity to cutaneous viral infection in patients with AD .


In a double-blind randomized study we investigated the safety and immunogenicity of live attenuated yellow fever virus ( YFV ) vaccination of nonatopic subjects and patients with AD after standard subcutaneous inoculation or transcutaneous vaccination administered with a bifurcated needle .


Viremia , neutralizing antibody , and antiviral T-cell responses were analyzed for up to @ days after vaccination .


YFV vaccination administered through either route was well tolerated .


Subcutaneous vaccination resulted in higher seroconversion rates than transcutaneous vaccination but elicited similar antiviral antibody levels and T-cell responses in both the nonatopic and AD groups .


After transcutaneous vaccination , both groups mounted similar neutralizing antibody responses , but patients with AD demonstrated lower antiviral T-cell responses by @ days after vaccination .


Among transcutaneously vaccinated subjects , a significant inverse correlation between baseline IgE levels and the magnitude of antiviral antibody and CD@ ( + ) T-cell responses was observed .


YFV vaccination of patients with AD through the transcutaneous route revealed that high baseline IgE levels provide a potential biomarker for predicting reduced virus-specific immune memory after transcutaneous infection with a live virus .


Optimal resuscitation of hypotensive trauma patients has not been defined .


This trial was performed to assess the feasibility and safety of controlled resuscitation ( CR ) versus standard resuscitation ( SR ) in hypotensive trauma patients .


Patients were enrolled and randomized in the out-of-hospital setting .


Nineteen emergency medical services ( EMS ) systems in the Resuscitation Outcome Consortium participated .


Eligible patients had an out-of-hospital systolic blood pressure ( SBP ) of @ mm Hg or lower .


CR patients received @ mL of fluid if they had no radial pulse or an SBP lower than @ mm Hg and additional @-mL boluses to maintain a radial pulse or an SBP of @ mm Hg or greater .


The SR group patients received @ L initially and additional fluid as needed to maintain an SBP of @ mm Hg or greater .


The crystalloid protocol was maintained until hemorrhage control or @ hours after hospital arrival .


A total of @ patients were randomized ( @ CR and @ SR ) .


The CR and SR groups were similar at baseline .


The mean ( SD ) crystalloid volume administered during the study period was @ L ( @ ) in the CR group and @ L ( @ ) in the SR group , a difference of @ L ( @ % confidence interval -LSB- CI -RSB- , @-@ @ ) .


Intensive care unit-free days , ventilator-free days , renal injury , and renal failure did not differ between the groups .


At @ hours after admission , there were @ deaths ( @ % ) in the CR group and @ ( @ % ) in the SR group ( adjusted odds ratio , @ ; @ % CI , @-@ @ ) .


Among patients with blunt trauma , @-hour mortality was @ % ( CR ) and @ % ( SR ) with an adjusted odds ratio of @ ( @-@ @ ) .


There was no difference among patients with penetrating trauma ( @ % vs. @ % ; adjusted odds ratio , @ ; @ % CI , @-@ @ ) .


CR is achievable in out-of-hospital and hospital settings and may offer an early survival advantage in blunt trauma .


A large-scale , Phase III trial to examine its effects on survival and other clinical outcomes is warranted .


Therapeutic study , level I.


Early and intensive blood pressure-lowering treatment seems to be beneficial in patients with acute hemorrhagic stroke and high blood pressure .


We wanted to see if similar benefits can be shown from a later and more gradual blood pressure lowering , using data from the Scandinavian Candesartan Acute Stroke Trial ( SCAST ) .


SCAST was a randomized - and placebo-controlled , double-masked trial of candesartan given for @ days , in @ patients with acute stroke and systolic blood pressure @ mm Hg .


We assessed the effects of candesartan in the @ patients with hemorrhagic stroke , using the trial 's @ coprimary effect variables : the composite vascular end point of vascular death , stroke or myocardial infarction , and functional outcome at @ months , according to the modified Rankin Scale .


We used Cox proportional hazards models and ordinal regression for analysis and adjusted for key , predefined prognostic variables .