Sixty term parturients scheduled to have elective cesarean section were randomly allocated into three groups to receive either 20 mL 2 % articaine ( Group A ) , 10 mL 2 % articaine + 10 mL 0.75 % ropivacaine ( Group AR ) or 20 mL 0.75 % ropivacaine ( Group R ) via lumbar epidural catheter .


The onset time of sensory block to T10 , T6 and maximum sensory block level , time to two segments regression from maximum sensory block level , onset time and duration of motor block were all recorded .


Intraoperative and postoperative additional analgesic requirements were also recorded .


Demographic data were similar .


The onset times of sensorial block to T10 and T6 were significantly shorter in Groups A and AR in comparison with Group R ( p < 0.05 ) .


The onset times of motor block were similar in all groups , but a more intense motor block was observed in Group R ( p < 0.05 ) .


Two segments regression time and motor block durations were significantly shorter in Groups A and AR in comparison with Group R ( p < 0.05 ) .


Intraoperative supplementary analgesic requirements were higher in Group A than in the other two groups ( p < 0.05 ) .


A combination of 2 % articaine and 0.75 % ropivacaine for epidural anesthesia in a cesarean section should be preferred over epidural 0.75 % ropivacaine alone .


Few clinical studies involving cigarettes have provided a comprehensive picture of smoke exposure , test article characterization , and insights into sensory properties combined .


The purpose of these pilot studies was to determine whether cigarettes with different levels of nicotine but similar tar levels would affect sensory experience or smoking behavior so as to significantly alter levels of selected biomarkers of exposure ( BOE ) .


In 2 confined , double-blind studies , 120 adult smokers switched from Marlboro Gold cigarettes at baseline to either 1 of 2 lower nicotine cigarettes or 1 of 2 higher nicotine cigarettes and then to the other cigarette after 5 days .


Urinary excretion of exposure biomarkers ( nicotine equivalents [ NE ] , total and free 4 - ( methylnitrosamino ) -1 - ( 3-pyridyl ) -1 - butanol [ NNAL ] , 1-hydroxypyrene , and 3-hydroxypropyl mercapturic acid ) as well as carboxyhemoglobin and plasma cotinine were measured at baseline , Day 5 , and Day 10 .


Daily cigarette consumption was monitored and sensory characteristics were rated for each cigarette .


With higher nicotine yield , urine NE , urine total NNAL , and plasma cotinine increased while nonnicotine BOE decreased without changes in cigarette consumption .


In contrast , with lower nicotine yield , urine NE , urine total NNAL , and plasma cotinine dropped while nonnicotine BOE and cigarettes per day increased .


Higher nicotine cigarettes were rated harsher and stronger than at baseline while lower nicotine cigarettes were less strong .


All 4 test cigarettes were highly disliked .


These studies demonstrate that abrupt increases or decreases in nicotine and the resulting sensory changes impact BOE through changes in intensity or frequency of smoking .


To compare the measurements and growth rates of geographic atrophy ( GA ) secondary to age-related macular degeneration ( AMD ) obtained using different imaging modalities .


Thirty patients with AMD and GA measuring from 1.25 mm to 18 mm based on spectral-domain optical coherence tomography ( SD-OCT ) fundus imaging were enrolled .


Imaging was performed at baseline and at follow-up months 3 , 6 , 9 , and 12 , including autofluorescence ( AF ) imaging with a fundus camera-based flash system ( TRC-50DX ; Topcon Medical Systems , Oakland , NJ ; AF excitation : 535-585 nm ; detection : 605-715 nm ) , AF and fluorescein angiography ( FA ) imaging with a confocal scanning laser ophthalmoscopy ( SLO ) system ( Spectralis ; Heidelberg Engineering , Heidelberg , Germany ; AF excitation : 488 nm ; detection : > 500 nm ) , and SD-OCT en face imaging ( Cirrus ; Carl Zeiss Meditec , Dublin , CA ) .


Average baseline square root measurements and enlargement rates of square root areas appeared similar across all modalities ; 0.2 mm was the largest difference between any pair of measurement means .


The intraclass correlation coefficients ( ICC ) were essentially equal to 1 for all comparisons of area measurements but were lower for growth rates than area measurements .


Comparison of 26-week average enlargement rates showed no significant difference between the SLO AF image and enhanced SD-OCT en face image ( mean difference : 0.01 mm ; SD : 0.10 ; P = .70 ) .


Agreement among all imaging modalities in measuring the areas of GA at baseline diminished when the growth rates of GA were compared over 26 weeks , likely because each imaging technique identifies different anatomic features along the border of GA , which may appear similar but change at different rates .


Red blood cell ( RBC ) transfusion is frequently used to treat women with acute anaemia after postpartum haemorrhage .


We aimed to assess the economic consequences of red blood cell transfusion compared to non-intervention in these women .


A trial-based cost-effectiveness analysis was performed alongside the Well-Being of Obstetric patients on Minimal Blood transfusions ( WOMB ) trial .


Women with acute anaemia [ Hb 48-79g / dl ( 30-49mm ) ] after postpartum haemorrhage , without severe anaemic symptoms , were randomly allocated to RBC transfusion or non-intervention .


Primary outcome of the trial was physical fatigue ( Multidimensional Fatigue Inventory , scale 4-20 ; 20 represents maximal fatigue ) .


Total costs per arm were calculated using a hospital perspective with a 6weeks time horizon .


Per woman , mean costs in the RBC transfusion arm ( n = 258 ) were 1957 compared to 1708 in the non-intervention arm ( n = 261 ; P = 0024 ) .


The 13 % difference in costs between study arms predominantly originated from costs of RBC units , as costs of RBC units were six times higher in the RBC transfusion arm .


RBC transfusion led to a small improvement in physical fatigue of 058 points per day ; thus , the costs to improve the physical fatigue score with one point would be 431 .


In women with acute anaemia after postpartum haemorrhage ( PPH ) , RBC transfusion is on average 249 more expensive per woman than non-intervention , with only a small gain in HRQoL after RBC transfusion .


Taking both clinical and economic consequences into account , implementation of a non-intervention policy seems justified .


Regular endotracheal tube cuff monitoring may prevent silent aspiration .


We hypothesised that active management of the cuff of the tracheal tube during deep hypothermic cardiac arrest would reduce silent subglottic aspiration .


We also determined to study its effect on postoperative mechanical ventilation and the incidence of postoperative positive tracheal cultures .


A randomised clinical trial .


The study was conducted in a University Teaching Hospital from September 2008 to November 2009 .


Twenty-four patients undergoing elective pulmonary endarterectomy were included in the study .


After induction of general anaesthesia and tracheal intubation , the cuff of the tracheal tube was inflated to 25cmH2O .


Following this , 1ml of methylene blue dye diluted in 2ml of physiological saline was injected into the hypopharynx .


Patients were randomly assigned to active cuff management during cooling and warming ( where cuff pressure was monitored and the cuff was reinflated if it dropped below 20cmH2O , or deflated if pressure exceeded 30cmH2O ) or passive monitoring ( where cuff pressure was monitored but volume was not altered ) .


Before weaning from cardiopulmonary bypass , fibreoptic bronchoscopy was performed .


Silent aspiration was then diagnosed if blue dye was seen in the trachea below the cuff of the tube .


The primary aim of this study was to determine the incidence of silent aspiration .


Secondary outcomes included duration of postoperative mechanical ventilation of the lungs and incidence of positive culture of tracheal aspirate .


Active cuff management patients were younger than controls ( 51.211.6 vs. 63.29 years , P = 0.028 ) , but otherwise the two groups were similar .


The primary endpoint was reached because we showed that silent aspiration was significantly less frequent in the study group ( 0/12 vs. 8/12 patients , P = 0.001 ) .


Significantly lower intracuff pressures were measured in the control group patients at several timepoints during cooling , just before hypothermic arrest and at all timepoints during rewarming .


We recommend that the cuff of the tracheal tube should be checked regularly during surgery under deep hypothermia , and the cuff pressure adjusted as required .


Cetuximab is a chimeric monoclonal antibody against the epidermal growth factor receptor ( EGFR ) .


Skin reactions are the most common side effects of cetuximab .


Rhagades of the tips of the fingers and toes , the heels and especially the interphalangeal joints are one of the most frightening and painful dermatological side effects that may develop from EGFR-inhibitor therapy .


Rhagades are characterized by pain , severe tenderness and poor healing response .


They are challenging to treat .


Thus , rhagades often poses the most significant threat to the quality of life ( QoL ) for these patients .


Ethyl-2-cyanoacrylate ( ECA ) , an ethyl ester of the 2-cyano-2-propenoic acid , is often used as adhesive in a variety of different work settings in industry , i.e. as a component in nail-care products such as nail glue .


In addition , ECA is used for various medical indications , such as for liquid bandages and for suture-less surgery .


Wound healing can be accelerated with ECA .


The purpose of the SUPPORT trial is to investigate the efficacy of ECA for the treatment of cetuximab-induced rhagades and to assess the clinical usefulness of the SUPO score , a new classification system for rhagades induced by EGFR-inhibitor therapy .


The SUPPORT trial is an open-label , prospective , randomized , national multicenter intervention study to evaluate the effectiveness of ECA versus the standard treatment of each institution on the pain intensity and QoL in patients with locally advanced head and neck cancer suffering from painful cetuximab-induced rhagades during radioimmunotherapy .


Primary endpoint is the assessment of the pain intensity 24 hours after application of ECA or the standard treatment quantified by the visual analogue scale ( VAS ) .


Secondary endpoints are the evaluation of QoL assessed by the EORTC-QoL-C30 questionnaire and the Dermatological Life Quality Index ( DLQI ) .


During treatment with EGFR inhibitors it is necessary to recognize and manage side effects promptly to assure better patient QoL .


The SUPPORT trial is the first randomized clinical trial evaluating a new treatment option for painful cetuximab-induced rhagades .


Furthermore , the new SUPO score will be prospectively assessed in terms of clinical usefulness for classification of EGFR inhibitor-induced rhagades .


Current Controlled Trials NCT01693159 .


The aim of this study was to characterize cardiac reactivity measures , heart rate ( HR ) , and heart rate variability ( HRV ) , following acute intravenous ( IV ) alcohol administration and their association with subjective responses in social drinkers .


Twenty-four subjects ( 11 females ) received IV alcohol infusions to attain and clamp the breath alcohol concentration ( BrAC ) at 50 mg % or placebo in separate sessions .


Serial 5-minute cardiac recordings at baseline and during the infusion were analyzed to obtain frequency and time domain cardiac measures .


Self-reported subjective perceptions were also obtained at the same time points .


HR showed significant decreases from baseline , while the HRV measure pNN50 showed steady increases during the ascending phase of alcohol infusion .


HR was inversely correlated with pNN50 across time and treatment .


There was a significant association of HR with subjective feelings of high , intoxication , feeling drug effects , and liking drug effects across time during the ascending phase .


Acute IV alcohol resulted in decreases in HR and increases in HRV consistent with autonomic parasympathetic activation .


The association of these changes with subjective responses suggests that cardiac reactivity may serve as a physiological marker of subjective alcohol effects .


This study broadens the understanding of acute cardiovascular effects of alcohol and clinically significant cardiac conditions such as arrhythmia and cardiomyopathy associated with chronic alcohol drinking .


A 5-h phase advance model of insomnia was used to evaluate the efficacy of lorediplon , a new non-benzodiazepine hypnotic .


Thirty-five male , healthy subjects were included in a five-way randomized cross-over study .


During each of the periods , sleep was recorded , and residual effects were measured .


All subjects received lorediplon 1 , 5 , and 10 mg , placebo , and zolpidem 10 mg ( i.e. , active control ) .


Polysomnographic evaluation revealed that lorediplon ( 5 and 10 mg ) significantly decreased wake after sleep onset ( WASO ) and increased total sleep time .


Analysis by quarters of the night showed a progressive increasing effectiveness of lorediplon 10 mg across the first three quarters .


Lorediplon increased non-rapid eye movement slow wave sleep and stage N2 sleep in the second and third quarters .


The magnitude of these effects was dose related , with minimal effects seen with 1 mg .


No residual effects were observed 13 h post dose .


Lorediplon demonstrated a dose-dependent improvement in sleep , whereas zolpidem showed a more sustained WASO effect .


No next-day hangover effects were observed .


These sleep effects are also consistent with the pharmacokinetic profile of lorediplon .


These results warrant clinical trials in patients with insomnia .


Whether adiposity indicators other than body mass index ( BMI ) should be used in studies of childhood asthma is largely unknown .


The role of atopy in `` obese asthma '' is also unclear .


To examine the relationship among adiposity indicators , asthma , and atopy in Puerto Rican children , and to assess whether atopy mediates the obesity-asthma association .


In a study of Puerto Rican children with ( n = 351 ) and without ( n = 327 ) asthma , we measured BMI , percent of body fat , waist circumference , and waist-to-hip ratio .


The outcomes studied included asthma , lung function , measures of atopy , and , among cases , indicators of asthma severity or control .


We performed mediation analysis to assess the contribution of atopy to the relationship between adiposity and asthma .


BMI , percent of body fat , and waist circumference were associated with increased odds of asthma .


Among cases , all 3 measures were generally associated with lung function , asthma severity/control , and atopy ; however , there were differences depending on the adiposity indicator analyzed .


Atopy considerably mediated the adiposity-asthma association in this population : allergic rhinitis accounted for 22 % to 53 % of the association with asthma , and sensitization to cockroach mediated 13 % to 20 % of the association with forced vital capacity and 29 % to 42 % of the association with emergency department visits for asthma .


Adiposity indicators are associated with asthma , asthma severity/control , and atopy in Puerto Rican children .


Atopy significantly mediates the effect of adiposity on asthma outcomes .


Longitudinal studies are needed to further investigate the causal role , if any , of adiposity distribution and atopy on `` obese asthma '' in childhood .


Preconception-initiated low-dose aspirin might positively affect pregnancy outcomes , but this possibility has not been adequately assessed .


Our aim was to investigate whether low-dose aspirin improved livebirth rates in women with one to two previous pregnancy losses .


In this multicentre , block-randomised , double-blind , placebo-controlled trial , women aged 18-40 years who were attempting to become pregnant were recruited from four medical centres in the USA .


Participants were stratified by eligibility criteria -- the original stratum was restricted to women with one loss at less than 20 weeks ' gestation during the previous year , whereas the expanded stratum included women with one to two previous losses , with no restrictions on gestational age or time of loss .


Women were block-randomised by centre and eligibility stratum in a 1:1 ratio .


Preconception-initiated daily low-dose aspirin ( 81 mg per day ) plus folic acid was compared with placebo plus folic acid for up to six menstrual cycles ; for women who conceived , study treatment continued until 36 weeks ' gestation .


Participants , trial staff , and investigators were masked to the assigned treatment .


The primary outcome was livebirth rate , which was analysed by intention to treat .


The trial is registered with ClinicalTrials.gov , number NCT00467363 .


Overall , 1228 women were recruited and randomly assigned between June 15 , 2007 , and July 15 , 2011 , 1078 of whom completed the trial and were included in the analysis ( 535 in the low-dose aspirin group and 543 in the placebo group ) .


309 ( 58 % ) women in the low-dose aspirin group had livebirths , compared with 286 ( 53 % ) in the placebo group ( p = 00984 ; absolute difference in livebirth rate 509 % [ 95 % CI -084 to 1102 ] ) .


Pregnancy loss occurred in 68 ( 13 % ) women in the low-dose aspirin group , compared with 65 ( 12 % ) women in the placebo group ( p = 07812 ) .


In the original stratum , 151 ( 62 % ) of 242 women in the low-dose aspirin group had livebirths , compared with 133 ( 53 % ) of 250 in the placebo group ( p = 00446 ; absolute difference in livebirth rate 920 % [ 051 to 1789 ] ) .


In the expanded stratum , 158 ( 54 % ) of 293 women in the low-dose aspirin group and 153 ( 52 % ) of 293 in the placebo group had livebirths ( p = 07406 ; absolute difference in livebirth rate 171 % [ -637 to 979 ] ) .


Major adverse events were similar between treatment groups .


Low-dose aspirin was associated with increased vaginal bleeding , but this adverse event was not associated with pregnancy loss .


Preconception-initiated low-dose aspirin was not significantly associated with livebirth or pregnancy loss in women with one to two previous losses .


However , higher livebirth rates were seen in women with a single documented loss at less than 20 weeks ' gestation during the previous year .


Low-dose aspirin is not recommended for the prevention of pregnancy loss .


Eunice Kennedy Shriver National Institute of Child Health and Human Development ( US National Institutes of Health ) .


To evaluate intereye corneal asymmetry in Pentacam ( Oculus Optikgerte GmbH , Wetzlar , Germany ) indices as a diagnostic method between normal patients and patients with keratoconus .


A retrospective , observational case series of 177 healthy , 44 indeterminate , and 121 patients with keratoconus classified by Pentacam ectasia detection indices , randomized to analysis and validation datasets .


Intereye asymmetry in 20 Scheimpflug tomography corneal descriptors was calculated and compared to develop diagnostic models .


Intereye asymmetry was not correlated with anisometropia in healthy controls but was correlated with the ectasia grade of the worse eye in patients with keratoconus .


Patients with keratoconus had significantly greater intereye asymmetry in all descriptors except for relational thickness indices .


Intereye asymmetry in front elevation at the thinnest corneal location afforded the single highest diagnostic performance ( 71 % sensitivity and 85 % specificity ) , whereas the best multivariate model combining intereye asymmetry in anterior and posterior keratometry , corneal thickness , and front and back elevation at the thinnest point provided 65 % sensitivity and 97 % specificity .


Multivariate models upheld their performance in the validation dataset .


Most ( more than 90 % ) indeterminate patients , according to conventional Pentacam analysis , showed within-normal-range corneal asymmetry .


Healthy corneas are markedly symmetric irrespective of anisometropia , but corneal asymmetry analysis does not provide sufficient sensitivity to be used alone for detecting keratoconus .


However , its remarkable specificity suggests that it could be used combined with conventional single cornea Pentacam analysis to reduce the false-positive rate or in dubious cases .


To determine effects of Argentine tango on motor and non-motor manifestations of Parkinson 's disease .


Randomized control trial .


Forty patients with idiopathic Parkinson 's disease .


Movement disorder clinic and dance studio .


Two randomized groups : group ( N = 18 ) with 24 partnered tango classes , and control self-directed exercise group ( N = 15 ) .


The primary outcome was overall motor severity .


Secondary outcomes included other motor measures , balance , cognition , fatigue , apathy , depression and quality of life .


On the primary intention-to-treat analysis there was no difference in motor severity between groups MDS-UPDRS-3 ( 1.6 vs.1.2-point reduction , p = 0.85 ) .


Patient-rated clinical global impression of change did not differ ( p = 0.33 ) , however examiner rating improved in favor of tango ( p = 0.02 ) .


Mini-BESTest improved in the tango group compared to controls ( 0.72.2 vs. -2.75.9 , p = 0.032 ) .


Among individual items , tango improved in both simple TUG time ( -1.31.6 s vs. 0.12.3 , p = 0.042 ) and TUG Dual Task score ( 0.40.9 vs. -0.20.4 , p = 0.012 ) , with borderline improvement in walk with pivot turns ( 0.20.5 vs. -0.10.5 , p = 0.066 ) .


MoCa ( 0.41.6 vs. -0.61.5 , p = 0.080 ) and FSS ( -3.610.5 vs. 2.56.2 , p = 0.057 ) showed a non-significant trend toward improvement in the tango group .


Tango participants found the activity more enjoyable ( p < 0.001 ) and felt more `` overall '' treatment satisfaction ( p < 0.001 ) .


We found no significant differences in other outcomes or adverse events .


Argentine tango can improve balance , and functional mobility , and may have modest benefits upon cognition and fatigue in Parkinson 's disease .


These findings must be confirmed in longer-term trials explicitly powered for cognition and fatigue .


The aim of this preliminary clinical report was to evaluate and compare the clinical outcomes of immediate and early loaded mini-implants ( MIs ) supporting mandibular overdentures .


Thirty-six completely edentulous patients ( 20 men and 16 women ) complaining of insufficient retention of their mandibular dentures were randomly assigned to two groups .


Each patient received four MIs in the interforaminal area of the mandible using the nonsubmerged flapless surgical approach .


In group 1 ( G1 ) , MIs were loaded with mandibular overdentures using the immediate loading protocol , while in group 2 ( G2 ) , MIs were loaded with overdentures using the early loading protocol .


The cumulative survival rate was calculated using Kaplan-Meier analysis .


Peri-implant health indices ( Plaque Index/Bleeding Index ) , probing depths , and marginal bone levels were recorded for both groups after MI insertions and 6 , 12 , 24 , and 36 months thereafter .


The cumulative implant survival rates were 91.7 % and 96.7 % for G1 and G2 , respectively .


G1 recorded significantly higher Plaque Index , Bleeding Index , and probing depths than G2 after 12 months , while other observation times demonstrated no significant difference between groups .


Most of the recorded marginal bone loss occurred in the first year , and no significant bone loss was noted in subsequent years .


After 6 months , marginal bone loss was significantly higher in G1 compared to G2 , but no significant differences between groups were noted thereafter .


Within the limitations of this study 's research design and duration of follow-up outcome analyses , immediate and early loading protocols showed good clinical results with favorable peri-implant tissue response 3 years after implant insertion .


Early loading of MIs supporting a mandibular overdenture appears to be preferable to immediate loading .


Gemigliptin is a novel dipeptidyl peptidase-4 ( DPP-4 ) inhibitor used in the treatment of type 2 diabetes mellitus .


This study evaluated possible pharmacodynamic and pharmacokinetic interactions between gemigliptin and metformin and investigated their tolerability .


A randomized , open-label , multiple-dose , three-treatment , three-period , three-sequence crossover study was conducted in healthy male subjects .


Twenty-seven subjects received gemigliptin ( 50mg once daily ) , metformin ( 1,000 mg twice a day ) , or both drugs for 7days per dosing period .


Blood samples were drawn over 24h on the seventh day of each period for pharmacokinetic and pharmacodynamic evaluations , including plasma DPP-4 activity and total/active glucagon-like peptide-1 ( GLP-1 ) levels .


Meal tolerance tests were conducted for pharmacodynamic assessment on the eighth day .


Safety and tolerability were evaluated using adverse events , vital signs , ECGs , and clinical laboratory tests .


Coadministration of gemigliptin and metformin had no significant effect on the pharmacokinetics of gemigliptin or metformin .


The inhibition of DPP-4 by gemigliptin was not affected by coadministration with metformin .


Co-therapy of gemigliptin and metformin showed additional effects by increasing plasma active GLP-1 concentrations and lowering serum glucose levels .


The plasma glucagon level was lower in co-therapy than with metformin monotherapy .


The coadministration of gemigliptin and metformin was well-tolerated without serious adverse events .


Coadministration of gemigliptin and metformin showed beneficial anti-diabetic effects without pharmacokinetic drug-drug interactions .


The purpose of the PROLUCA study is to investigate the efficacy of preoperative and early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer with special focus on exercise .


Using a 2 x 2 factorial design with continuous effect endpoint ( Maximal Oxygen Uptake ( VO2peak ) ) , 380 patients with non-small cell lung cancer ( NSCLC ) stage I-IIIa referred for surgical resection will be randomly assigned to one of four groups : ( 1 ) preoperative and early postoperative rehabilitation ( starting two weeks after surgery ) ; ( 2 ) preoperative and late postoperative rehabilitation ( starting six weeks after surgery ) ; ( 3 ) early postoperative rehabilitation alone ; ( 4 ) today 's standard care which is postoperative rehabilitation initiated six weeks after surgery .


The preoperative rehabilitation program consists of an individually designed , 30-minute home-based exercise program performed daily .


The postoperative rehabilitation program consists of a supervised group exercise program comprising cardiovascular and resistance training two-hour weekly for 12 weeks combined with individual counseling .


The primary study endpoint is VO2peak and secondary endpoints include : Six-minute walk distance ( 6MWD ) , one-repetition-maximum ( 1RM ) , pulmonary function , patient-reported outcomes ( PROs ) on health-related quality of life ( HRQoL ) , symptoms and side effects of the cancer disease and the treatment of the disease , anxiety , depression , wellbeing , lifestyle , hospitalization time , sick leave , work status , postoperative complications ( up to 30 days after surgery ) and survival .


Endpoints will be assessed at baseline , the day before surgery , pre-intervention , post-intervention , six months after surgery and one year after surgery .


The results of the PROLUCA study may potentially contribute to the identification of the optimal perioperative rehabilitation for operable lung cancer patients focusing on exercise initiated immediately after diagnosis and rehabilitation shortly after surgery .


NCT01893580 .


To investigate the safety and feasibility of domestically made endoscopic stapling instrument in laparoscopic assisted rectal cancer resection ( Dixon ) .


Sixty-four patients with rectal cancer were randomly divided into the research group ( 35 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 ( 29 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 > 0.05 ) , but the average cost of endoscopic stapling instrument was significantly lower in the research group ( 6604.31 699.95 vs 7822.28 576.98 RMB Yuan , P < 0.05 ) .


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 1-3 .


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 = 632 ) , stratified by disease extent , were randomly assigned ( 1:1 ) to receive axitinib/gemcitabine or placebo/gemcitabine .


Axitinib was administered at a starting dose of 5 mg orally twice daily and gemcitabine at 1000 mg/m ( 2 ) once weekly for 3 weeks in 4 week cycles .


Primary endpoint was overall survival .


Among Japanese patients , median overall survival was not estimable ( 95 % confidence interval , 7.4 months-not estimable ) with axitinib/gemcitabine ( n = 58 ) and 9.9 months ( 95 % confidence interval , 7.4-10 .5 ) with placebo/gemcitabine ( n = 56 ) ( hazard ratio 1.093 [ 95 % confidence interval , 0.525-2 .274 ] ) .


Median survival follow-up ( range ) was 5.1 months ( 0.02-12 .3 ) with axitinib/gemcitabine vs. 5.4 months ( 1.8-10 .5 ) 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 2 Diabetes ( BARI 2D ) was a study of management strategies for diabetic patients with myocardial ischemia and coronary artery disease .


In a 22 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 2D 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 347 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 2D showed that early CABG in patients with type 2 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 ( 1-week baseline and 4-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 .1500 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 1:1:1 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 .


Australian New Zealand Clinical Trials Registry ACTRN12614000644662 ( registered 18 June 2014 ) .


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 = 32,048 ) 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 .


Registered with Clinical Trials.gov ,


NCT01176383 .


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 , 4-way crossover design , cats received 0.88-1 .26 mg/kg PO q12h fOT , ORP , famotidine , and placebo ( lactose capsules ) .


Intragastric pH monitoring was used to continuously record intragastric pH for 96 hours beginning on day 4 of treatment .


Plasma omeprazole concentrations at steady state ( day 7 ) were determined by high performance liquid chromatography ( HPLC ) with ultraviolet detection .


Mean percentage time that intragastric pH was 3 and 4 were compared among groups using ANOVA with a posthoc Tukey-Kramer test ( = 0.05 ) .


The mean percentage time SD that intragastric pH was 3 was 68.4 35.0 % for fOT , 73.9 23.2 % for ORP , 42.8 18.6 % for famotidine , and 16.0 14.2 % 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 , 12 consecutive patients were treated with SAL alone on 1 side and with SAL plus RFAL on the other side .


Each patient had 4 ( 3 3-cm ) squares-2 per treatment type-tattooed in the lower abdominal region ( 2 on the right and 2 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 6 weeks posttreatment , and at 1 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 10.4 % mean skin surface area contraction at 6 weeks and 8.3 % at 1 year posttreatment .


The mean skin surface area reduction was 25.8 % in regions treated with radiofrequency plus SAL at 6 weeks and at 1 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 66 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 15 days .


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


Of the 66 professionals , 87.9 % were females .


Of a total possible score of ten , the mean score obtained in the pre-test was 5.3 3 , and in the second test , 7.5 2 ( p < 0.000 ) .


There were no significant differences when comparing the two groups ( p = 0.726 ) .


The nurses had the lowest mean scores in the initial test ( 2.3 2 ) ; however , they were the group that learned the most with the intervention , showing similar means to those of other groups in the second test ( 6.1 3 ) .


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 120 patients undergoing laparoscopic cholecystectomy were randomly assigned into three groups : Pregabalin group received 150 mg of pregabalin , gabapentin group received 600 mg of gabapentin and diclofenac group received 100 mg of diclofenac sodium orally 2 h prior to surgery .


Anesthesia was induced with fentanyl 3 g/kg , propofol 2-2 .5 mg/kg and succinylcholine 1.5 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 24 h. Post-operative pain relief was provided with fentanyl based patient-controlled analgesia .


Fentanyl consumption in 24 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 15 , 14 and 13 patients in pregabalin , gabapentin and diclofenac sodium group respectively ( P > 0.85 ) .


Patients in diclofenac group had significantly higher fentanyl consumption ( 674.85 115.58 g ) compared with pregabalin group ( 601.87 129.57 g ) ( 95 % confidence interval [ CI ] = 34.8-120 .7 ) and gabapentin group ( 612.29 105.12 g ) ( 95 % CI = 14.9-170 .5 ) .


However , there was no significant difference in fentanyl consumption between pregabalin and gabapentin groups ( 95 % CI = -34.8 -120.7 ) .


There was a significant difference in visual analog score at time points 12 , 18 and 24 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 306 of the 313 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 ( 74.5 % ) and all were included in the study ; forceps ( n = 115 ) and vacuum extractor ( n = 113 ) .


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 47 % , bowel habit urgency was reported by 44 % ( 98/225 ) , and loss of bowel control ` sometimes ' or ` frequently ' by 20 % of women ( 46/226 ) .


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


Overall , 13 % ( 20/158 ) of children were noted to have visual problems .


There was no significant difference in visual function between the two groups : ventouse 11/86 ( 12.8 % ) , compared with forceps 9/72 ( 12.5 % ) ; odds ratio 0.97 , 95 % CI 0.38-2 .50 .


Of the 20 children with visual problems , a family history was known in 18 , and 17/18 ( 94 % ) 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 25mg/week with initial prednisolone 30mg/day ) compared with the original COBRA therapy ( methotrexate 7.5 mg/week , sulfasalazine 2g/day , with initial prednisolone 60mg/day ) after 26weeks in patients with early active rheumatoid arthritis ( RA ) .


To assess the non-inferiority of COBRA-light versus COBRA after 1year in terms of disease activity ( DAS44 ) , 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 162 patients with active early RA , following a treat-to-target protocol incorporating the addition of etanercept if DAS44 1.6 at weeks 26 or 39 .


Both groups showed major improvements in DAS44 after 52weeks : mean ( SD ) -2.41 ( 1.2 ) in the COBRA and -2.02 ( 1.0 ) 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 96 % of the patients in both groups .


In total , 25 serious adverse events occurred : 9 vs 16 in COBRA and COBRA-light , respectively .


Treatment actually instituted was often less intensive than required by the protocol : of the total population , 108 patients ( 67 % ) required etanercept ( more in the COBRA-light group ) , but only 67 of these ( 62 % ) actually received it .


Intensive COBRA or COBRA-light therapy has major , comparably favourable effects on disease activity , functional ability and radiological outcome after 1year 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 .


ISRCTN55552928 .


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 376 adults enrolled in a randomized controlled trial ( RCT ) of Type 2 diabetes ( T2DM ) 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 : 0.10 ; p = 0.002 ) 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 T2DM .


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 T2DM 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 18-75 years referred for the assessment of suspected angina due to coronary heart disease from 12 cardiology chest pain clinics across Scotland .


We randomly assigned ( 1:1 ) 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 6 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 NCT01149590 .


Between Nov 18 , 2010 , and Sept 24 , 2014 , we randomly assigned 4146 ( 42 % ) of 9849 patients who had been referred for assessment of suspected angina due to coronary heart disease .


47 % of participants had a baseline clinic diagnosis of coronary heart disease and 36 % had angina due to coronary heart disease .


At 6 weeks , CTCA reclassified the diagnosis of coronary heart disease in 558 ( 27 % ) patients and the diagnosis of angina due to coronary heart disease in 481 ( 23 % ) patients ( standard care 22 [ 1 % ] and 23 [ 1 % ] ; p < 00001 ) .


Although both the certainty ( relative risk [ RR ] 256 , 95 % CI 233-279 ; p < 00001 ) and frequency of coronary heart disease increased ( 109 , 102-117 ; p = 00172 ) , the certainty increased ( 179 , 162-196 ; p < 00001 ) and frequency seemed to decrease ( 093 , 085-102 ; p = 01289 ) for the diagnosis of angina due to coronary heart disease .


This changed planned investigations ( 15 % vs 1 % ; p < 00001 ) and treatments ( 23 % vs 5 % ; p < 00001 ) but did not affect 6-week symptom severity or subsequent admittances to hospital for chest pain .


After 17 years , CTCA was associated with a 38 % reduction in fatal and non-fatal myocardial infarction ( 26 vs 42 , HR 062 , 95 % CI 038-101 ; p = 00527 ) , 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 .


The Chief Scientist Office of the Scottish Government Health and Social Care Directorates funded the trial with supplementary awards from Edinburgh and Lothian 's Health Foundation Trust and the Heart Diseases Research Fund .


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 S2-glass fibers ( Dentapreg ) and multidirectional preimpregnated E-glass fibers ( Dentapreg ) ( length : 40 mm ; thickness : 0.5 mm ) were obtained ( N = 144 , n = 12 per group ) and embedded in translucent silicone material with the adhesion surface exposed .


The resulting specimens were randomly divided into 12 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 ( 1 mm/min ) .


On additional specimens from each FRC type , thermogravimetric analysis ( TGA ) was performed to characterize the fiber weight content ( Wf ) ( N = 6 , n = 3 per group ) .


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


The data were statistically analyzed using 3-way ANOVA and Tukey 's tests ( = 0.05 ) .


Significant effects of the FRC type ( S2 or E-glass ) ( p < 0.01 ) , resin type ( PFC or FR ) ( p < 0.01 ) and polymerization protocol ( p < 0.05 ) were observed on the bond strength ( MPa ) .


Interaction terms were also significant ( p < 0.05 ) .


The multidirectional FRC groups ( g to l ) showed significantly lower bond strengths ( 2.3 0.2 to 7.3 0.3 MPa ) than did the unidirectional FRC groups ( a to f ) ( 10.7 0.6 to 24.4 0.8 MPa ) .


Among the unidirectional FRC groups , the highest values were obtained with protocol f ( 24.4 0.8 ) , followed by protocol e ( 18.6 0.4 ) .


PFC adhesion to unidirectional FRC was lower when FRC and PFC were polymerized in one step ( protocol a : 11.3 0.5 ) than individual polymerization ( protocol c : 14.1 0.5 ) .


The opposite situation was true for FR ( protocol b : 17.5 0.4 ; protocol d : 10.7 0.6 ) .


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 55 3 wt % fiber content for multidirectional and 60 3 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 20g of MCT or corn oil ( LCT ) at breakfast .


Blood samples were obtained over 3h .


In Study 1 ( n = 10 ) , an ad lib lunch was served after 3h .


In Study 2 ( n = 7 ) , a preload containing 10g of test oil was given at 3h and lunch was served 1h 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 1 only .


Food intake at the lunch test meal after the MCT preload ( Study 2 ) was ( means.e.m . )


532389kcal vs 804486kcal after LCT ( P < 0.05 ) .


MCT consumption resulted in a lower rise in triglycerides ( P = 0.014 ) and glucose ( P = 0.066 ) and a higher rise in peptide YY ( PYY , P = 0.017 ) and leptin ( P = 0.036 ) compared with LCT ( combined data ) .


Correlations between differences in hormone levels ( glucagon-like peptide ( GLP-1 ) , 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-1 , 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 262 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 : ( 1 ) educational material ( the usual care comparison ) , ( 2 ) feedback of practice rates of high-risk prescribing received by both intervention arms and ( 3 ) 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 ( 2 ) .


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 .


ClinicalTrials.gov : NCT01602705 .


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 90mg 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 24 hours after the procedure ) associated with new or worsened upper abdominal , epigastric , or back pain .


In total , 380 patients were randomized , and 343 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 20/170 patients ( 11.8 % ) in the placebo group and in 22/173 patients ( 12.7 % ) in the diclofenac group ( P = 0.87 ) .


Multivariate regression analysis failed to illustrate that intramuscular diclofenac prevented PEP ( odds ratio 0.79 ; 95 % confidence interval 0.39-1 .25 ; P = 0.51 ) .


Prophylactic intramuscular diclofenac had no beneficial preventive effect on PEP.Clinicaltrials.gov NCT01717599 .


Infusion of PDA-001 , 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-001 in patients with multiple sclerosis .


This was a phase 1b , multicenter , randomized , double-blind , placebo-controlled , 2-dose ranging study including patients with relapsing-remitting multiple sclerosis or secondary progressive multiple sclerosis .


The study was conducted at 6 sites in the United States and 2 sites in Canada .


Patients were randomized 3:1 to receive 2 low-dose infusions of PDA-001 ( 15010 ( 6 ) cells ) or placebo , given 1 week apart .


After completing this cohort , subsequent patients received high-dose PDA-001 ( 60010 ( 6 ) 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 ( 5 new gadolinium lesions on 2 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 6 with secondary progressive multiple sclerosis were randomly assigned to treatment : 6 to low-dose PDA-001 , 6 to high-dose PDA-001 , and 4 to placebo .


No patient met Cutters rule .


One patient receiving high-dose PDA-001 had an increase in T2 and gadolinium lesions and in Expanded Disability Status Scale score during a multiple sclerosis flare 5 months after receiving PDA-001 .


No other patient had an increase in Expanded Disability Status Scale score > 0.5 , and most had stable or decreasing Expanded Disability Status Scale scores .


With high-dose PDA-001 , 1 patient experienced a grade 1 anaphylactoid reaction and 1 had grade 2 superficial thrombophlebitis .


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


PDA-001 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 = 34 ) or a cisplatin ( DDP ) group ( n = 34 ) .


The NDP group received NDP 80-100 mg/m iv on day 1 + leucovorin ( CF ) 100 mg/m iv on days 1-5 + 5-fluorouracil ( 5-FU ) 500 mg/m iv on days 1-5 .


The DDP group received DDP 30 mg/m iv on days 1-3 + CF 100 mg/m on days 1-5 + 5-FU 500 mg/m iv on days 1-5 .


The treatment was repeated every 4 wk in both groups .


Concurrent radiotherapy [ 60-66 Gy / ( 30-33 f ) / ( 6-7 wk ) ] was given during chemotherapy .


There was no significant difference in the short-term response rate between the NDP group and DDP group ( 90.9 % vs 81.3 % , P = 0.528 ) .


Although the 1 - and 2-year survival rates were higher in the NDP group than in the DDP group ( 75.8 % vs 68.8 % , 57.6 % vs 50.0 % ) , the difference in the overall survival rate was not statistically significant between the two groups ( P = 0.540 ) .


The incidences of nausea , vomiting and nephrotoxicity were significantly lower in the NDP group than in the DDP group ( 17.6 % vs 50.0 % , P = 0.031 ; 11.8 % vs 47.1 % , P = 0.016 ; 8.8 % vs 38.2 % , P = 0.039 ) .


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 24I .


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 50 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 60 patients with acute-onset NAION .


Patients in the comparison ( PFX ) group ( n = 30 ) received PFX intravenously and per os for 7 days and then per os for a further 6 months , which is a standard treatment .


Patients in the intervention ( PFX + FC ) group ( n = 30 ) received the standard treatment plus 1 mg/kg FC for 5 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 3 days and 6 months after therapy onset .


Visual field ( VF ) was analyzed using standard automated perimetry at the initial baseline examination and at 6 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 , 0.22 ; after 3 days and 6 months of treatment , 0.33 and 0.43 , respectively ) than PFX patients ( mean BCVA scores : at baseline , 0.33 ; after 3 days and 6 months of treatment , 0.33 and 0.28 , respectively ; p < 0.002 and 0.001 ) .


The beneficial effect was even more marked 6 months after therapy onset .


Remarkably , patients with a baseline BCVA score of > = 0.05 profited significantly by FC treatment ( p < 0.006 and 0.001 ) , whereas those with a baseline BCVA score of < 0.05 did not ( p < 0.4 ) .


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 ( 0.44 g/dl of GOS ) and the subsequent feeding of a GOS-containing follow-on formula ( 0.50 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 365 healthy term infants enrolled before 8 weeks of age and randomly assigned to a formula with or without GOS , until 12 months of age .


The incidence of infections and allergy manifestations , the antibiotics prescribed and faecal characteristics were recorded up to 12 months of age , while faecal samples were collected up to 4 months for the measurement of secretory immunoglobulin A , short-chain fatty acids and microbiota .


A prebiotic effect on the faecal analysis was observed at 4 months of life .


The GOS group showed a lower faecal pH ( P = 0.019 ) , a lower decreasing trend in secretory immunoglobulin A ( P = 0.078 ) , lower butyric acid concentration ( P = 0.040 ) and an increase in Bifidobacterium counts ( P = 0.010 ) .


Changes in faecal characteristics involved greater frequency ( P < 0.001 ) and softer consistency ( P < 0.05 ) .


The incidence of infections or allergic manifestations during the first year of life was similar in both groups , with no statistical differences ( P > 0.05 ) .


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-3 , n-6 and n-9 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 ( 90 cm for males and 84 cm for females ) , and at least one other criterion : triglycerides 1.7 mmol/L , high density lipoprotein cholesterol < 1 mmol/L ( males ) or < 1.3 mmol/L ( females ) , blood pressure 130 mmHg ( systolic ) and/or 85 mmHg ( diastolic ) , and glucose 5.5 mmol/L .


Weight-maintaining diets that included shakes with one of the dietary oil blends were provided during each of the five 30-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 130 completed the study with a dropout rate of 23.5 % .


The mean plasma total DHA concentrations , which were analyzed among all participants as a measure of adherence , increased by more than 100 % 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-3 , n-6 , and n-9 fatty acid-containing oils on CVD risks .


ClinicalTrials.gov NCT01351012 .


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 2005 to 2010 was evaluated for outcome including technical and clinical success , survival , complications and reoperation .


A SEMS was inserted in 334 patients , including 264 ( 79.0 % ) for palliation and 52 ( 15.6 % ) as a bridge to surgery .


Technical success was achieved in 292 ( 87.4 % ) patients , with 46 ( 13.8 % ) experiencing a complication or technical failure .


Reoperation was required in 39 ( 14.8 % ) patients stented for palliation of colorectal cancer of whom 16 ( 6.1 % ) subsequently required a colostomy .


A one-stage primary anastomosis was achieved in 35 ( 67.3 % ) of the 52 patients undergoing stenting as a bridge to resection .


Technical success did not vary by indication or site of obstruction ( P = 0.60 ) but was higher for operators who had performed more than 10 procedures ( OR 3.34 , P = 0.001 ) .


ASA grade 3 predicted a worse clinical outcome ( OR 0.43 , P = 0.04 ) .


The through-the-scope ( TTS ) endoscopy technique was more successful than radiological placement alone ( 90.3 % vs 74.8 % , P < 0.001 ) .


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 , 2-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 < .0001 , presentation global P = .07 ) , which demonstrated a significant improvement in 5 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 174 girls ( aged 8-10 years at baseline ) , a subset from the Cohort Study of Young Girls ' Nutrition , Environment , and Transitions .


Trained observers completed street audits within a 0.25-mile radius around each girl 's residence .


Four scales ( food and service retail , recreation , walkability , and physical disorder ) were created from 40 observed neighborhood features .


BMI was calculated from clinically measured height and weight .


Obesity was defined as BMI-for-age 95 % .


Logistic regression models using generalized estimating equations were used to examine neighborhood influences on obesity risk over 4 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 1-SD increase on the food and service retail scale was associated with a 2.27 ( 95 % confidence interval , 1.42 to 3.61 ; P < .001 ) increased odds of being obese .


A 1-SD increase in physical disorder was associated with a 2.41 ( 95 % confidence interval , 1.31 to 4.44 ; P = .005 ) 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 2-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 330 patients over 24 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 12-item Short-Form Health Survey questionnaires were transformed into utilities values using the SF-6D mapping algorithm .


Costs were calculated by extracting Diagnosis-Related Group codes from institutional billing data and then applying 2012 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 3 % annual discount rate .


Patients included in the original RCT had to be diagnosed as having radiculopathy or myeloradiculopathy at 2 contiguous levels from C3-C7 that was unresponsive to conservative treatment for at least 6 weeks or demonstrated progressive symptoms .


Incremental cost-effectiveness ratio of CTDR compared with ACDF .


A strong correlation ( R2 = 0.6864 ; P < .001 ) was found by projecting a visual analog scale onto the Neck Disability Index .


Cervical total disc replacement had an average of 1.58 QALYs after 24 months compared with 1.50 QALYs for ACDF recipients .


Cervical total disc replacement was associated with $ 2139 greater average cost .


The incremental cost-effectiveness ratio of CTDR compared with ACDF was $ 24,594 per QALY at 2 years .


Despite varying input parameters in the sensitivity analysis , the incremental cost-effectiveness ratio value stays below the threshold of $ 50,000 per QALY in most scenarios ( range , - $ 58,194 to $ 147,862 per QALY ) .


The incremental cost-effectiveness ratio of CTDR compared with traditional ACDF is lower than the commonly accepted threshold of $ 50,000 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-4 ( DPP-4 ) inhibitors are a new class of antihyperglycemic drugs that block degradation ofincretin hormones .


To assess the effects oftreatment with DPP-4 inhibitors on glucoregulation and body weight in obese patients with type 2 diabetes mellitus .


The study included 9 females and 9 males with type 2 diabetes ( n = 18 ) , BMI = 31.24 + / - 2,26 kg/m2 , mean age 58 + / - 6,8 years .


The patients have been thoroughly evaluated before treatment , and 6 months after treatment with DPP-4 inhibitor ( sitagliptin ) in combination with metformin .


After 6 months of treatment with DPP-4 inhibitors in combination with metformin HbAlc ( -1,49 % ) .


, FBG ( -3.75 mmol/L ) and PBG ( -5.79 mmol/L ) significantly reduced ( p = 0.000 ) .


Mean body weight also significantly reduced ( -12.5 % ; p = 0.000 ) .


Reduction of mean fasting insulin was 5.46 mIU/L or 27 % ( p = 0.000 ) .


Mean HOMA-IR change was -1.64 ( p = 0.000 ) .


Also there was significant decreasing of systolic blood pressure ( p = 0.001 ) , cholesterol ( p = 0.004 ) , triglycerides ( p = 0.001 ) , LDL ( p = 0.002 ) and increasing of HDL ( p = 0.002 ) .


Hypoglycaemia was not registered in any of the patients .


These results show that in obese patients with type 2 diabetes , DPP-4 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 3-year period .


This was a randomised trial in 155 patients with non-diabetic CKD comparing aliskiren ( 150 mg/day ) ( n = 52 ) versus losartan ( 100 mg/day ) ( n = 52 ) and the third group aliskiren ( 150 mg/day ) combined with losartan ( 100 mg/day ) ( n = 51 ) .


The trial utilised primary renal end points of eGFR < 15 ml/min or end-stage renal failure .


All three groups had significant reduction of proteinuria ( p < 0.001 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 = 9 ) at rest , before and after a 10-week training program , compared with a non-training control group ( n = 9 ) .


VLDL-TG kinetics were assessed by a primed constant infusion of [ 1-14C ] VLDL-TG , and VLDL-TG oxidation by specific activity ( 14CO2 ) in expired air .


The metabolic study days were placed 60-72h after the last exercise bout .


Palmitate kinetics and oxidation were assessed by a 2h constant infusion of [ 9,10 - ( 3 ) H ] palmitate .


In the training group ( n = 9 ) , maximal oxygen uptake increased significantly by 20 % ( P < 0.05 ) , and the insulin sensitivity ( assessed by the hyperinsulinemic-euglycemic clamp ) improved significantly ( P < 0.05 ) .


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


We conclude that 10 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 = 20 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 < 0.05 ) ; the SFT group had significantly lower scores of problem solving , communication , roles , affective involvement , behavior control , and general functioning than the control group ( P < 0.05 ) .


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 < 0.05 ) , and the SFT group was significantly superior to the control group in terms of these items ( P < 0.05 ) .


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 82 adults with type 1 or type 2 diabetes receiving daily injections of insulin or glucagon-like peptide-1 ( GLP-1 ) agonists .


Participants received 17 subcutaneous injections ( 12 in abdomen , 5 in thigh ) of saline at different injection speeds ( 150 , 300 and 450 l/s ) , with different volumes ( 400 , 800 , 1200 and 1600 l ) , and two needle insertions without any injection .


Pain was evaluated on a 100-mm visual analogue scale ( VAS ) ( 0 mm no pain , 100 mm worst pain ) and on a yes/no scale for pain acceptability .


Injection speed had no impact on injection pain ( p = 0.833 ) .


Injection of larger volumes caused significantly more pain [ VAS least square mean differences 1600 vs. 400 l , 7 2 mm ( 95 % confidence interval - CI ; 4.6-9 .7 ; p < 0.0001 ) ; 1600 vs. 800 l , 7.2 mm ( 4.4-10 .0 ; p < 0.0001 ) ; 1200 vs. 400 l , 3.5 mm ( 0.4-6 .6 ; p = 0.025 ) and 1200 vs. 800 l , 3.6 mm ( 0.4-6 .7 ; p = 0.027 ) ] .


Significantly more pain occurred in the thigh versus the abdomen [ 9.0 mm ( 6.7-11 .3 ; p < 0.0001 ) ] .


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 2011 to 2014 .


One hundred seventy-eight ( 178 ) patients were evaluated at 90 days for surgical site infection .


Infections were categorized as early infections less than 30 days of the index procedure and late after 90 days .


Early vascular surgical site infection occurred in 7 ( 8.24 % ) of patients in the Vancomycin arm , and 11 ( 11.83 % ) in the Daptomycin arm ( P = 0.43 ) .


Gram-positive related infections and MRSA infections occurred in 1 ( 1.18 % ) / 0 ( 0 % ) of Vancomycin patients and 9 ( 9.68 % ) / 1 ( 1.08 % ) of Daptomycin patients , respectively ( P < 0.02 and P = 1.00 ) .


Readmissions related to surgical site infections occurred in 4 ( 4.71 % ) in the Vancomycin group and 11 ( 11.8 % ) in the Daptomycin group ( P = 0.11 ) .


Patients undergoing operative exploration occurred in 5 ( 5.88 % ) in the Vancomycin group and 10 ( 10.75 % ) of the Daptomycin group ( P = 0.17 ) .


Late infections were reported in 3 patients , 2 of which were in the combined Daptomycin group .


Median hospital charges related to readmissions due to a surgical site infection was $ 50,823 in the combination Vancomycin arm and $ 110,920 in the combination Daptomycin group ; however , no statistical significance was appreciated ( P = 0.11 ) .


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 1:1 ) 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 0.80 , and will be conducted with the aim of achieving a post-percutaneous coronary intervention fractional flow reserve target value of 0.90 .


In the optical coherence tomography arm , percutaneous coronary intervention will be performed if percentage of area stenosis ( AS % ) is 75 % or 50 to 75 % with minimal lumen area < 2.5 mm2 , 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 < 90 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 .


Clinicaltrials.gov NCT01824030 .


The aim of this study was to evaluate the prognostic value of MSI-H and p53 overexpression in metastatic colorectal cancer ( mCRC ) treated with oxaliplatin and fluoropyrimidine-based first line chemotherapy .


Tumour samples were retrospectively obtained from 229 patients from a prospective randomised phase III trial of the AIO colorectal study group , comparing CAPOX and FUFOX in mCRC .


Immunohistochemistry of p53 and MMR proteins as well as microsatellite analysis were performed .


The incidence of MSI-H and p53 overexpression was 7.9 % and 65.4 % , respectively .


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


We observed a trend to lower DCR for MSI-H tumours ( 65 % vs. 85 % , p = 0.055 ) .


p53 overexpression was not correlated with DCR , ORR and PFS .


The median OS of patients with tumors with p53 overexpression was significantly longer compared to tumors withhout p53 overexpression ( 19.6 vs. 15.8 months ; p = 0.05 ) .


The post-progression survival ( PPS ) of p53-positive patients undergoing 2nd and/or 3rd line chemotherapy with irinotecan and/or cetuximab was significantly longer compared to p53-negative patients .


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


mCRC patients with p53 overexpression undergoing an irinotecan containing second - or third-line chemotherapy after oxaliplatin failure have a significantly longer post-progression survival compared to patients without p53 overexpression .


To validate the clinical impact of p53 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 2 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 8 weeks of treatment from 39 patients with pulmonary TB from Kampala , Uganda enrolled in a Centers for Disease Control and Prevention ( CDC ) TB Trials Consortium Phase 2B treatment trial .


We identified protein expression differences associated with 8-week culture status , including Coagulation Factor V , SAA , XPNPEP1 , PSME1 , IL-11 R , HSP70 , Galectin-8 , 2-Antiplasmin , ECM1 , YES , IGFBP-1 , CATZ , BGN , LYNB , and IL-7 .


Markers noted to have differential changes between responders and slow-responders included nectin-like protein 2 , EphA1 ( Ephrin type-A receptor 1 ) , gp130 , CNDP1 , TGF-b RIII , MRC2 , ADAM9 , and CDON .


A logistic regression model combining markers associated with 8-week culture status revealed an ROC curve with AUC = 0.96 , sensitivity = 0.95 and specificity = 0.90 .


Additional markers showed differential changes between responders and slow-responders ( nectin-like protein ) , or correlated with time-to-culture-conversion ( KLRK1 ) .


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 8-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 ( 2 ) 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 626 patients , divided between Matrix ( 2 ) and bare metal coil groups .


The primary outcome was target aneurysm recurrence at 12 3 months .


At 455 days , at least 1 target aneurysm recurrence event had occurred in 14.6 % of patients treated with bare metal coils and 13.3 % of Matrix ( 2 ) ( P = .76 , log-rank test ) patients ; 92.8 % of target aneurysm recurrence events were re-interventions for aneurysms that had not bled after treatment , and 5.8 % of target aneurysm recurrence events resulted from hemorrhage or rehemorrhage , with or without retreatment .


Symptomatic re-intervention occurred in only 4 ( 0.6 % ) patients .


At 455 days , 95.8 % of patients with unruptured aneurysms and 90.4 % of those with ruptured aneurysms were independent ( mRS 2 ) .


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


Tested Matrix ( 2 ) 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 2 groups : intervention ( group 1 ) , with 17 subjects ; and control ( group 2 ) , also with 17 subjects .


Data were collected from October 2010 to October 2011 , and the study population comprised 7-20-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 2 weeks .


Thirty-four subjects were included in the study , 20 of whom were boys ( 58.5 % ) .


The groups were similar at baseline .


In group 1 , 6 subjects ( 35.2 % ) reported practicing physical exercises regularly .


The mean age was 13.4 2.8 y , the mean percent-of-predicted FEV1 was 95.5 17.9 % , and the mean peak oxygen uptake ( VO2 ) relative to body mass was 34.9 9.0 mL/kg/min .


In group 2 , 4 subjects ( 23.5 % ) reported practicing physical exercises regularly .


The mean age was 12.7 3.3 y , the mean percent-of-predicted FEV1 was 100.1 21.2 % , and the mean peak VO2 was 33.2 8.2 mL/kg/min .


In group 1 , there was a significant increase in physical exercise practice as reported by subjects after 3 months of intervention compared with group 2 ( P = .01 ) .


No statistically significant differences were found for the other variables .