The blood from internal jugular vein was drawn respectively before induction ( T@ ) , and @ min ( T@ ) , @ min ( T@ ) and @ min ( T@ ) after one-lung ventilation ( OLV ) , and @ min ( T@ ) after two-lung ventilation .


The contents of plasma endothelin ( ET ) , nitric oxide ( NO ) and calcitonin gene-related peptide ( CGRP ) were detected with enzyme linked immunosorbent assay ( ELISA ) .


Meanwhile , arterial and mixed venous blood samples were collected for determination of blood gas and calculation of intrapulmonary shunt fraction ( Qs/Qt ) .


During OLV , ET contents were increased significantly in two groups ( P < @ ) , and no significant difference was presented ( P > @ ) .


NO content in group S was obviously higher than in group N at T@ ( P < @ ) , whereas CGRP content in group N was markedly lower than in group S at each time point ( P < @ ) .


Qs/Qt was significantly increased in both groups after OLV , but there was no statistical significant regarding the Qs/Qt at each time point between two groups .


Total intravenous anesthesia combined with SGB is conducive to regulation of perioperative vasomotor cytokines in thoracotomy , and has little effect on intrapulmonary shunt at the time of OLV .


Lenalidomide plus dexamethasone is a reference treatment for relapsed multiple myeloma .


The combination of the proteasome inhibitor carfilzomib with lenalidomide and dexamethasone has shown efficacy in a phase @ and @ study in relapsed multiple myeloma .


We randomly assigned @ patients with relapsed multiple myeloma to carfilzomib with lenalidomide and dexamethasone ( carfilzomib group ) or lenalidomide and dexamethasone alone ( control group ) .


The primary end point was progression-free survival .


Progression-free survival was significantly improved with carfilzomib ( median , @ months , vs. @ months in the control group ; hazard ratio for progression or death , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ) .


The median overall survival was not reached in either group at the interim analysis .


The Kaplan-Meier @-month overall survival rates were @ % and @ % in the carfilzomib and control groups , respectively ( hazard ratio for death , @ ; @ % CI , @ to @ ; P = @ ) .


The rates of overall response ( partial response or better ) were @ % and @ % in the carfilzomib and control groups , respectively ( P < @ ; @ % and @ % of patients in the respective groups had a complete response or better ; @ % and @ % had a stringent complete response ) .


Adverse events of grade @ or higher were reported in @ % and @ % of patients in the carfilzomib and control groups , respectively ; @ % and @ % of patients discontinued treatment owing to adverse events .


Patients in the carfilzomib group reported superior health-related quality of life .


In patients with relapsed multiple myeloma , the addition of carfilzomib to lenalidomide and dexamethasone resulted in significantly improved progression-free survival at the interim analysis and had a favorable risk-benefit profile .


( Funded by Onyx Pharmaceuticals ; ClinicalTrials.gov number , NCT@ . )


One of the most important challenges in public health is to improve the quality of life in elders .


Aging may cause various disorders such as disabilities , high risk conditions and some chronic disease .


In this study the effect of educational intervention based on precede-proceed on quality of life in elders was examined .


This semi experimental study was carried out on @ elders over @ years in Zahedan that were randomly selected by multi-stage sampling method and divided in to control and intervention groups .


Data collection tool was a triploid questionnaire that included demographic data , questions of precede-proceed constructs and SF-@ questionnaire .


The validity and reliability of questionnaire confirmed by experts and Cranach 's Alpha coefficient ( @ % ) .


After primary data collecting , educational intervention was performed and after nine months data was collected again and analyzed in spss @ soft-ware using descriptive and analytical statistics .


The results showed that mean score of quality of life in participants was low and more than @ % of them had a mean score less than @ % .


After intervention the mean score of quality of life only in experimental group significantly increased from @ to @ .


Behavior and self-rated health were the strongest predictors for quality of life in this study .


Implementation educational intervention based on precedes-proceed model can improve quality of life in elders .


Elderly women and older elderly individuals compared with elderly men and younger elderly should be considering as an important risk factor for reducing HRQOL .


Yes-associated protein ( YAP@ ) is frequently reported to function as an oncogene in many types of cancer , but in breast cancer results remain controversial .


We set out to clarify the role of YAP@ in breast cancer by examining gene and protein expression in subgroups of patient material and by downregulating YAP@ in vitro and studying its role in response to the widely used anti-estrogen tamoxifen .


YAP@ protein intensity was scored as absent , weak , intermediate or strong in two primary breast cancer cohorts ( n = @ and n = @ ) and mRNA expression of YAP@ was evaluated in a gene expression dataset ( n = @ ) .


Recurrence-free survival was analysed using the log-rank test and Cox multivariate analysis was used to test for independence .


WST-@ assay was employed to measure cell viability and a luciferase ERE ( estrogen responsive element ) construct was used to study the effect of tamoxifen , following downregulation of YAP@ using siRNAs .


In the ER + ( Estrogen Receptor positive ) subgroup of the randomised cohort , YAP@ expression was inversely correlated to histological grade and proliferation ( p = @ and p = @ , respectively ) whereas in the ER - ( Estrogen Receptor negative ) subgroup YAP@ expression correlated positively to proliferation ( p = @ ) .


Notably , low YAP@ mRNA was independently associated with decreased recurrence-free survival in the gene expression dataset , specifically for the luminal A subgroup ( p < @ ) which includes low proliferating tumours of lower grade , usually associated with a good prognosis .


This subgroup specificity led us to hypothesize that YAP@ may be important for response to endocrine therapies , such as tamoxifen , extensively used for luminal A breast cancers .


In a tamoxifen randomised patient material , absent YAP@ protein expression was associated with impaired tamoxifen response which was significant upon interaction analysis ( p = @ ) .


YAP@ downregulation resulted in increased progesterone receptor ( PgR ) expression and a delayed and weaker tamoxifen in support of the clinical data .


Decreased YAP@ expression is an independent prognostic factor for recurrence in the less aggressive luminal A breast cancer subgroup , likely due to the decreased tamoxifen sensitivity conferred by YAP@ downregulation .


Clinical validation of laboratory toothbrushing tests has important advantages .


It was , therefore , the aim to demonstrate correlation of tooth cleaning efficiency of a new robot brushing simulation technique with clinical plaque removal .


Clinical programme : @ subjects received dental cleaning prior to @-day-plaque-regrowth-interval .


Plaque was stained , photographically documented and scored using planimetrical index .


Subjects brushed teeth @-@ with three techniques ( horizontal , rotating , vertical ) , each for @s buccally and for @s orally in @ consecutive intervals .


The force was calibrated , the brushing technique was video supported .


Two different brushes were randomly assigned to the subject .


Robot programme : Clinical brushing programmes were transfered to a @-axis-robot .


Artificial teeth @-@ were covered with plaque-simulating substrate .


All brushing techniques were repeated @ times , results were scored according to clinical planimetry .


All data underwent statistical analysis by t-test , U-test and multivariate analysis .


The individual clinical cleaning patterns are well reproduced by the robot programmes .


Differences in plaque removal are statistically significant for the two brushes , reproduced in clinical and robot data .


Multivariate analysis confirms the higher cleaning efficiency for anterior teeth and for the buccal sites .


The robot tooth brushing simulation programme showed good correlation with clinically standardized tooth brushing.This new robot brushing simulation programme can be used for rapid , reproducible laboratory testing of tooth cleaning .


Patients surviving stroke but who have significant impairment of function in the affected arm are at more risk of developing pain , stiffness and contractures .


The abnormal muscle activity , associated with post-stroke spasticity , is thought to be causally associated with the development of these complications .


Treatment of spasticity is currently delayed until a patient develops signs of these complications .


This protocol is for a phase II study that aims to identify whether using OnabotulinumtoxinA ( BoNT-A ) in combination with physiotherapy early post stroke when initial abnormal muscle activity is neurophysiologically identified can prevent loss of range at joints and improve functional outcomes.The trial uses a screening phase to identify which people are appropriate to be included in a double blind randomised placebo-controlled trial .


All patients admitted to Sandwell and West Birmingham NHS Trust Hospitals with a diagnosis of stroke will be screened to identify functional activity in the arm .


Those who have no function will be appropriate for further screening .


Patients who are screened and have abnormal muscle activity identified on EMG will be given electrical stimulation to forearm extensors for @ months and randomised to have either injections of BoNT-A or normal saline .


The primary outcome measure is the action research arm test - a measure of arm function .


Further measures include spasticity , stiffness , muscle strength and fatigue as well as measures of quality of life , participation and caregiver strain .


To observe the efficacy and safety of Qizhi Jiangtang Capsule ( QJC ) in treating stage @b diabetic kidney disease ( DKD ) patients with macroalbuminuria .


Patients who conformed to the diagnostic criteria of stage @b DKD were randomly assigned to two groups according to random digital table , the experiment group and the control group , @ in each group .


All patients received a two-week elution period , and then were treated with basic Western therapy .


Patients in the experiment group took QJC , @ pills per time , @ times a day , while those in the control group took Valsartan Capsule @ mg each time , once daily .


The observation period of follow-ups was limited within @ months , and the time points were set as the baseline , @st month , @rd month , and @th month .


Systolic blood pressure ( SBP ) , diastolic blood pressure ( DBS ) , @ h urine protein quantitative ( @ h UPQ ) , plasma albumin ( ALB ) , and serum creatinine ( SCr ) were detected and recorded , and estimated glomerular filtration rate ( eGFR ) was calculated .


The occurrence of hypoglycemic reaction , coagulation disorder , gastrointestinal tract reaction , allergy , hyperkalemia , doubling of creatinine , and overall adverse events were observed and recorded at same time .


Finally @ patients in the experiment group and @ patients in the control group were effectively included .


Compared with the baseline level , SBP and DBS obviously decreased in the control group at month @ of treatment ( P < @ ) , and more significantly decreased at month @ of treatment ( P < @ ) .


SBP at month @ , @ , and @ of follow-ups ; DBS at month @ of follow-ups was lower in the control group than in the experiment group ( P < @ ) .


At month @ , @ , and @ of follow-ups , @ h UPQ of the experiment group was significantly lower than the baseline level ( P < @ ) .


It was also significantly lower than the level of the control group at the same time point ( P < @ ) .


There was no significant difference in @ h UPQ at month @ , @ , and @ of follow-ups between the control group and the baseline level ( P > @ ) .


ALB of the experiment group showed an increasing trend .


It was significantly higher than the baseline level at month @ ( P < @ ) , which was also higher than that of the control group at same period ( P < @ ) .


There was no significant difference in the ALB level in the control group ( P > @ ) .


SCr of two groups showed an increasing trend .


SCr of the experiment group was significantly higher at month @ , @ , and @ follow-ups than the baseline level ( P < @ ) .


But the increment of SCr was higher in the control group than in the experimental group , and obviously higher than the baseline levels ( P < @ ) .


eGFR of both groups showed a decreasing trend .


The decrement was higher in the control group than in the experimental group ( P < @ ) .


The proportion of progression of renal functions at month @ , @ , and @ of follow-ups in the experimental group was @ % ( @ case ) , @ % ( @ cases ) , and @ % ( @ cases ) , while they were @ % ( @ cases ) , @ % ( @ cases ) , and @ % ( @ cases ) in the control group .


There was no statistical difference in the proportion of progression of renal functions between the two groups at month @ and @ of follow-ups ( P < @ ) .


There was no statistical difference in the incidence of adverse reactions between two groups ( P > @ ) .


QJC could effectively reduce urinary protein of patients with stage @b DKD , and delay the progression of renal functions .


To investigate and compare several quantification methods of myocardial perfusion measurements , paying special attention to the relation between the techniques and the required measurement duration .


Seven patients underwent contrast-enhanced rest and stress cardiac perfusion measurements at @T .


Three slices were acquired in each patient and were divided into @ segments , leading to @ rest and stress data curves , which were analyzed using various tracer kinetic models as well as a model-free deconvolution .


Plasma flow , plasma volume , and myocardial perfusion reserve were analyzed for the complete acquisition as well as for the first pass data only .


Deconvolution analysis yielded stable results for both rest and stress analysis , while Fermi and one compartment models agree well for first pass data ( rest measurements only ) and prolonged data acquisition ( stress measurements only ) .


More complex models do not yield satisfactory results for the short measurement times investigated in this study .


When performing MRI-based quantification of myocardial perfusion , care must be taken that the method used is appropriate for the time frame under investigation .


When a numerical deconvolution is used instead of tracer kinetic models , more stable results are obtained .


Combining pharmacotherapies for tobacco-dependence treatment may increase smoking abstinence .


To determine efficacy and safety of varenicline and bupropion sustained-release ( SR ; combination therapy ) compared with varenicline ( monotherapy ) in cigarette smokers .


Randomized , blinded , placebo-controlled multicenter clinical trial with a @-week treatment period and follow-up through week @ conducted between October @ and April @ at @ midwestern clinical research sites .


Five hundred six adult ( @ years ) cigarette smokers were randomly assigned and @ ( @ % ) completed the study .


Twelve weeks of varenicline and bupropion SR or varenicline and placebo .


Primary outcome was abstinence rates at week @ , defined as prolonged ( no smoking from @ weeks after the target quit date ) abstinence and @-day point-prevalence ( no smoking past @ days ) abstinence .


Secondary outcomes were prolonged and point-prevalence smoking abstinence rates at weeks @ and @ .


Outcomes were biochemically confirmed .


At @ weeks , @ % of the combination therapy group achieved prolonged smoking abstinence and @ % achieved @-day point-prevalence smoking abstinence compared with @ % and @ % in varenicline monotherapy ( odds ratio -LSB- OR -RSB- , @ ; @ % CI , @-@ @ ; P = @ and OR , @ ; @ % CI , @-@ @ ; P = @ , respectively ) .


At @ weeks , @ % of the combination therapy group achieved prolonged and @ % achieved @-day point-prevalence smoking abstinence compared with @ % and @ % in varenicline monotherapy ( OR , @ ; @ % CI , @-@ @ ; P = @ and OR , @ ; @ % CI , @-@ @ ; P = @ , respectively ) .


Participants receiving combination therapy reported more anxiety ( @ % vs @ % ; P = @ ) and depressive symptoms ( @ % vs @ % ; P = @ ) .


Among cigarette smokers , combined use of varenicline and bupropion , compared with varenicline alone , increased prolonged abstinence but not @-day point prevalence at @ and @ weeks .


Neither outcome was significantly different at @ weeks .


Further research is required to determine the role of combination therapy in smoking cessation .


To study the efficacy of transdermal clonidine in the treatment of severe refractory hyperemesis gravidarum ( HG ) , the most severe illness of pregnancy .


The study had a randomised , double - blind , placebo-controlled , cross-over design ( RCT ) .


Single tertiary referral hospital after admission of patients .


Twelve women of gestational age @-@ weeks and a major grade of HG clinical severity who were unresponsive to standard antiemetic treatment .


The patients were randomly treated with and without the active drug ( @ mg patch ) for two consecutive periods of @ days .


The patients were allocated to a random list to receive first placebo and then active drug or the other way round .


Other antiemetic drugs were administered on a scheduled or as-needed basis .


All patients received intravenous hydration and thiamine supplementation .


Pregnancy Unique Quantification of Emesis ( PUQE ) and visual analog scale ( VAS ) clinical scores , positive morning urine ketonuria , number of doses of standard antiemetic drugs required , and number of days off intravenous therapy were compared in the two periods .


Transdermal clonidine led to a significantly greater improvement compared with placebo of the primary ( PUQE score P = @ CI @-@ @ ; VAS score P = @ CI @-@ @ ) and secondary outcome measures .


A reduction of blood pressure was reported for systolic @ mmHg P = @ and diastolic @ mmHg P = @ .


This preliminary RCT demonstrates the efficacy of transdermal clonidine in the treatment of severe HG , leading to a significant reduction of symptoms and reducing the need for other supportive measures and medications .


Maternal obesity and gestational diabetes mellitus ( GDM ) may independently influence offspring fat mass and metabolic disease susceptibility .


In this pilot study , body composition and fat distribution in offspring from obese women with and without GDM and lean women were assessed within the @st year of life , and maternal and newborn plasma factors were related to offspring adipose tissue distribution .


Serum and plasma samples from pregnant obese women with ( n = @ ) or without ( n = @ ) GDM and normoglycemic lean women ( n = @ ) at @rd trimester and offspring cord plasma were used for analyzing lipid profiles , insulin and adipokine levels .


At week-@ and @ , month-@ and year-@ , offspring anthropometrics and skinfold thickness ( SFT ) were measured and abdominal subcutaneous ( SCA ) and preperitoneal adipose tissue ( PPA ) were determined by ultrasonography .


Cord insulin was significantly increased in the GDM group , whereas levels of cord leptin , total and high molecular weight ( HMW ) adiponectin were similar between the groups .


Neonates of the GDM group showed significantly higher SFT and fat mass until week-@ and significantly increased SCA at week-@ compared to the lean group that persisted as strong trend at week-@ .


Interestingly , PPA in neonates of the GDM group was significantly elevated at week-@ compared to both the lean and obese group .


At month-@ and year-@ , significant differences in adipose tissue growth between the groups were not observed .


Multiple linear regression analyses revealed that cord insulin levels are independently related to neonatal PPA that showed significant relation to PPA development at year-@ .


Maternal fasted C-peptide and HMW adiponectin levels at @rd trimester emerged to be determinants for PPA at week-@ .


Maternal pregravid obesity combined with GDM leads to newborn hyperinsulinemia and increased offspring fat mass until week-@ , whereas pregravid obesity without GDM does not .


This strongly suggests the pivotal role of GDM in the adverse offspring outcome .


Maternal C-peptide and HMW adiponectin levels in pregnancy emerge to be predictive for elevated PPA in newborns and might be indicative for the obesity risk at later life .


Altogether , the findings from our pilot study warrant evaluation in long-term studies .


While effective in preventing stroke in patients with atrial fibrillation ( AF ) , warfarin is limited by a narrow therapeutic profile , a need for lifelong coagulation monitoring , and multiple drug and diet interactions .


To determine whether a local strategy of mechanical left atrial appendage ( LAA ) closure was noninferior to warfarin .


PROTECT AF was a multicenter , randomized ( @:@ ) , unblinded , Bayesian-designed study conducted at @ hospitals of @ patients with nonvalvular AF and at least @ additional stroke risk factor ( CHADS@ score @ ) .


Enrollment occurred between February @ and June @ and included @-year follow-up through October @ .


Noninferiority required a posterior probability greater than @ % and superiority a probability of @ % or greater ; the noninferiority margin was a rate ratio of @ comparing event rates between treatment groups .


Left atrial appendage closure with the device ( n = @ ) or warfarin ( n = @ ; target international normalized ratio , @-@ ) .


A composite efficacy end point including stroke , systemic embolism , and cardiovascular/unexplained death , analyzed by intention-to-treat .


At a mean ( SD ) follow-up of @ ( @ ) years ( @ patient-years ) , there were @ events among @ patients ( @ % ) in the device group for a primary event rate of @ events per @ patient-years , compared with @ events among @ patients ( @ % ) for a primary event rate of @ events per @ patient-years with warfarin ( rate ratio , @ ; @ % credible interval , @-@ @ ) , meeting prespecified criteria for both noninferiority ( posterior probability , > @ % ) and superiority ( posterior probability , @ % ) .


Patients in the device group demonstrated lower rates of both cardiovascular mortality ( @ events per @ patient-years for the device group -LSB- @/@ patients , @ % -RSB- vs @ events per @ patient-years with warfarin -LSB- @/@ patients , @ % -RSB- ; hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @-@ @ ; P = @ ) and all-cause mortality ( @ events per @ patient-years for the device group -LSB- @/@ patients , @ % -RSB- vs @ events per @ patient-years with warfarin -LSB- @/@ patients , @ % -RSB- ; HR , @ ; @ % CI , @-@ @ ; P = @ ) .


After @ years of follow-up among patients with nonvalvular AF at elevated risk for stroke , percutaneous LAA closure met criteria for both noninferiority and superiority , compared with warfarin , for preventing the combined outcome of stroke , systemic embolism , and cardiovascular death , as well as superiority for cardiovascular and all-cause mortality .


Despite great reduction of in-stent restenosis , first-generation drug-eluting stents ( DESs ) have increased the risk of late stent thrombosis due to delayed endothelialization .


Arsenic trioxide , a natural substance that could inhibit cell proliferation and induce cell apoptosis , seems to be a promising surrogate of sirolimus to improve DES performance .


This randomized controlled trial was to evaluate the efficacy and safety of a novel arsenic trioxide-eluting stent ( AES ) , compared with traditional sirolimus-eluting stent ( SES ) .


Patients with symptoms of angina pectoris were enrolled and randomized to AES or SES group .


The primary endpoint was target vessel failure ( TVF ) , and the second endpoint includes rates of all-cause death , cardiac death or myocardial infarction , target lesion revascularization ( TLR ) by telephone visit and late luminal loss ( LLL ) at @-month by angiographic follow-up .


From July @ to @ , @ patients were enrolled and randomized @:@ to receive either AES or SES .


At @ years of follow-up , TVF rate was similar between AES and SES group ( @ % vs. @ % , P = @ ) .


Frequency of all-cause death was significantly lower in AES group ( @ vs. @ % , P = @ ) .


There was no significant difference between AES and SES in frequency of TLR and in-stent restenosis , but greater in-stent LLL was observed for AES group ( @ @ mm vs. @ @ mm , P = @ ) .


After @ years of follow-up , AES demonstrated comparable efficacy and safety to SES for the treatment of de novo coronary artery lesions .


Raltegravir is an HIV-@ integrase inhibitor approved for use in adults , children and infants @ weeks of age .


As alternatives to the original film-coated tablet , a chewable ethylcellulose ( EC ) tablet and oral granules for suspension ( GFS ) have been developed for use in children .


The purpose of this study was to evaluate these formulations in adults prior to use in paediatric studies .


This open-label , @-period , randomized , crossover study investigated the safety , tolerability and pharmacokinetics of raltegravir paediatric formulations and the effect of a high-fat meal on EC tablet pharmacokinetics in healthy adults .


In a balanced , crossover design ( with a @-day washout between treatments ) , @ subjects received one @ mg film-coated tablet ( fasted ) , four @ mg EC tablets ( fasted ) , one @ mg GFS dose ( fasted ) and four @ mg EC tablets ( after a high-fat meal ) .


AUC@ - and Cmax were @-fold and @-fold higher for GFS and @-fold and @-fold higher for EC versus film-coated tablets .


The geometric mean C@h values for the GFS formulation ( @ nM ) and the EC tablet ( @ nM ) were similar to that of the film-coated tablet ( @ nM ) .


Administration with a high-fat meal increased C@h , decreased Cmax and delayed Tmax for the EC tablet , but did not affect AUC@ - .


There were no serious adverse events ( AEs ) and no discontinuations due to drug-related clinical or laboratory AEs .


Both paediatric formulations demonstrate moderately higher AUC@ - and Cmax , and similar C@h compared with the film-coated tablet .


These data support the use of raltegravir GFS and EC formulations in paediatric studies .


To determine the effect of neonatal caffeine treatment on rates of developmental coordination disorder ( DCD ) .


Children in the Caffeine for Apnea of Prematurity trial were assessed for motor performance ( Movement Assessment Battery for Children -LSB- MABC -RSB- ) , clinical signs of cerebral palsy , and Full-Scale IQ at @ years of age by staff who were unaware of the children 's treatment group .


DCD was defined as MABC < @th percentile in children with a Full-Scale IQ > @ who did not have a diagnosis of cerebral palsy .


There were @ children with known MABC corrected-age percentile as well as known Full-Scale IQ at @ years and cerebral palsy status , of whom @ had been randomly assigned to caffeine and @ to placebo therapy .


The rate of DCD was lower in those treated with caffeine ( @ % ) than in the placebo group ( @ % ) ( OR adjusted for center and baseline covariates , @ , @ % CI , @-@ @ ; P = @ ) .


Neonatal caffeine therapy for apnea of prematurity reduces the rate of DCD at @ years of age .


As more children have DCD than have cerebral palsy , this is an important additional benefit from neonatal caffeine treatment .


To determine whether exercise training might exert anti-inflammatory effect by reducing HMGB@ levels in women with breast cancer ( BC ) .


We analyzed monocentric data from the DIANA ( DIET AND ANDROGENS ) -@ PROJECT .


Study population consisted of @ patients randomized into two groups : @ patients ( @ + / - @ yrs , training group ) were assigned to a structured exercise training intervention ( @ times/week for the first @ months , and once / week for the following @ months ) ; whereas @ patients ( @ + / - @ yrs , control group ) followed only the general indications to adhere to the life-style intervention suggestions of the DIANA protocol .


At study entry and after @ months , all patients underwent cardiopulmonary exercise testing , biochemical as - sessment -LSB- HMGB@ , high-sensitivity C-reactive protein ( hs-CRP ) , interleukin-@ ( IL-@ ) -RSB- ; and lipid and glycemic profile .


There were no significant differences between groups in baseline clinical and inflammatory profile .


Among the training group , only @/@ patients had high adherence to the exercise intervention .


After stratifying the study population according to the level of adhesion to the exer - cise intervention , @-year HMGB@ levels were lower among patients more adherent to exercise ( p for trend = @ ) .


Further adjusting for age , body mass index and baseline values , @-year HMGB@ levels remained significantly and inversely associated to the level of adhesion to the exercise intervention ( B = -@ , SE = @ , p = @ ) .


Moderate intensity exercise training in BC survivors is associated with reduced HMGB@ levels that are proportional to the level of adhesion to the exercise intervention , independently from other classical inflammatory molecules , suggesting an exercise-induced anti-inflammatory effect mediated by HMGB@ .


According to the literature , @ % of injuries affecting school-age children are sports related .


The role of physical education students , as future teachers , seems to be of high importance in terms of protecting children 's safety during sports classes .


The aim is to evaluate the level of basic life support ( BLS ) knowledge and skills in physical education students instructed with the use of different methods .


Second-year physical education students ( n = @ , M age = @ years ) were randomly assigned to three groups : experimental @ ( E@ ) , experimental @ ( E@ ) , and control ( C ) .


Group E@ students participated in a @-hour BLS course based on computer-assisted presentations .


Group E@ trainees practiced BLS algorithm in pairs during a @-hour course .


No manikins were used in both intervention groups .


Students of Group C were asked to learn BLS algorithm on their own .


All groups fulfilled a @-question multiple-choice test on BLS at the beginning and the end of the experiment .


After completing the course participants performed BLS on a manikin .


The results of knowledge test were not significant before an experiment but differed essentially among the groups afterward ( analysis of variance contrast analysis , p < @ ) .


Regardless of teaching method used , no significant differences were found among the students in preparatory BLS actions and cardiopulmonary resuscitation ( CPR ) performance on a manikin .


The level of CPR performance was very low in all groups .


Students of both intervention groups improved their BLS knowledge after the training .


Teaching methods used in the current study seemed to be ineffective in terms of practical CPR skills .


Access to greater number of modern manikins should improve the BLS training in physical education students .


Moreover , permanent consultation on instructional methods with emergency medicine experts is recommended for university teachers .


This study evaluated the efficacy and safety of levosimendan , a positive inotropic drug with vasodilator effects , given intravenously to patients with acutely decompensated heart failure ( ADHF ) .


We performed @ sequential trials , the first to develop a new measure of efficacy in @ patients , and the second to use this measure to evaluate levosimendan in an additional @ patients .


Patients admitted with ADHF received placebo or intravenous levosimendan for @ h in addition to standard treatment .


The primary endpoint was a composite that evaluated changes in clinical status during the first @ days after randomization .


In the @-patient trial , more levosimendan than placebo patients ( @ vs. @ ) were improved at all @ pre-specified time points ( @ h , @ h , and @ days ) , whereas fewer levosimendan patients ( @ vs. @ ) experienced clinical worsening ( p = @ for the difference between the groups ) .


These differences were apparent , despite more frequent intensification of adjunctive therapy in the placebo group ( @ vs. @ patients ) .


Improvements in patient self-assessment and declines in B-type natriuretic peptide levels with levosimendan persisted for @ days and were associated with reduced length of stay ( p = @ ) .


Similar findings were present in the @-patient pilot trial .


Levosimendan was associated with more frequent hypotension and cardiac arrhythmias during the infusion period and a numerically higher risk of death across the @ trials ( @ of @ on a regimen of levosimendan vs. @ of @ on a regimen of placebo at @ days , p = @ ) .


In patients with ADHF , intravenous levosimendan provided rapid and durable symptomatic relief .


As dosed in this trial , levosimendan was associated with an increased risk of adverse cardiovascular events .


( Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure ; NCT@ ) .


To compare the treatment outcome of tamsulosin @ mg ( TAM ) with or without solifenacin @ mg ( SOL ) for the most bothersome symptom in male lower urinary tract symptoms ( LUTS ) with overactive bladder ( OAB ) .


Male LUTS/OAB ( @ years ) patients who had a total International Prostate Symptom Score ( I-PSS ) of @ , I-PSS urgency-related question of @ , and quality of life ( QoL ) of @ points were enrolled .


Patients who complained of storage symptoms as the most bothersome were included in the ` storage ' group .


Patients who complained of voiding symptoms as the most bothersome were included in the ` voiding ' group .


The change in the I-PSS was compared between the two groups @ weeks after commencing treatment .


In the storage group , @ were able to finish this study ( TAM : @ , TAM + SOL : @ ) .


The improvement of I-PSS and QoL with TAM + SOL was significantly greater than with TAM alone ( p < @ ) .


In the voiding group , @ were able to finish the study ( TAM : @ , TAM + SOL : @ ) .


The improvement of I-PSS and QoL with TAM alone was significantly greater than with TAM + SOL ( p < @ ) .


The most bothersome symptom in male LUTS/OAB should be considered when choosing the appropriate medical treatment .


Multiple phase-@ trials in men with biochemically-recurrent prostate cancer ( BRPC ) have assessed the impact of nonhormonal agents on PSA kinetics .


We have previously demonstrated that changes in PSA kinetics correlate with metastasis-free survival ; however , it is unknown whether these changes also correlate with overall survival ( OS ) .


We performed a combined retrospective analysis of @ men with BRPC treated on phase-@ trials using one of four investigational drugs : lenalidomide ( n = @ ) , marimastat ( n = @ ) , ATN-@ ( n = @ ) and imatinib ( n = @ ) .


We examined factors influencing OS , including within-subject changes in PSA kinetics ( PSA slope , PSA doubling time and PSA velocity ) , before and @ months after treatment initiation .


After a median follow-up of @ months , @ of @ men had died .


In univariate Cox regression analysis , two factors were associated with OS : baseline PSA velocity and change in PSA velocity on therapy .


In a landmark multivariable model , stratified by study ( which controlled for age , Gleason score , type of local therapy and use of androgen-deprivation therapy prior to metastases ) , baseline PSA velocity and increase in PSA velocity on therapy remained independent predictors of OS .


Median OS for men with an increase in PSA velocity on treatment was @ months and was not reached for men with a decrease in PSA velocity ( hazard ratio = @ , @ % confidence interval @-@ @ ; P = @ ) .


This hypothesis-generating study suggests that within-subject changes in PSA velocity after initiation of nonhormonal therapy may correlate with OS in men with BRPC .


If validated in prospective trials , change in PSA velocity may represent a reasonable intermediate end point for screening new agents in these patients .


The aims of the present study were to evaluate the efficacy of and compliance with a new device for autoinflation in the treatment of persistent otitis media with effusion ( OME ) in young children .


Forty-five children with persistent OME with a bilateral type B or C@ tympanogram for at least three months and history of subjective hearing loss , waiting for grommet surgery , were randomised to a treatment and a control group .


Twenty-three children aged between three and eight years started as the treatment group with the new device for autoinflation .


Another @ children , aged between two and eight years were included as controls .


After a period of four weeks , a cross-over was performed .


Both groups underwent otomicroscopy , tympanometry and audiometry at inclusion and after one and two months for the evaluation of treatment efficiency .


The primary outcome measurements were improvement in middle-ear pressure and hearing thresholds at eight weeks .


Both groups were then followed up for another @ months .


In the treatment group , the mean middle-ear pressure for both ears and the mean hearing thresholds for the best ear improved by @ daPa ( p < @ ) and @ dB ( p < @ ) , respectively after four weeks , while in the control group , non-significant alterations were observed .


After the cross-over of the control group to treatment , equivalent improvements in the mean middle-ear pressure and the mean hearing thresholds of @ daPa ( p < @ ) and @ dB ( p < @ ) , respectively were achieved also in this group .


After treatment in both groups at eight weeks , four of @ children were submitted to grommet surgery .


During the long-term follow-up another five children were submitted to surgery due to recurrence of disease .


All the children managed to perform the manoeuvre and no side-effects were detected .


The device demonstrated efficiency in improving both middle-ear pressure and hearing thresholds in most children after four weeks of treatment .


It might therefore be possible to consider this method of autoinflation in children with persistent OME during the watchful waiting period .


The negative consequences of unhealthy weight gain and the high likelihood of pediatric obesity tracking into adulthood highlight the importance of targeting youth who are ` at risk ' of obesity .


The aim of this paper is to report the rationale and study protocol for the ` Active Teen Leaders Avoiding Screen-time ' ( ATLAS ) obesity prevention intervention for adolescent boys living in low-income communities .


The ATLAS intervention will be evaluated using a cluster randomized controlled trial in @ secondary schools in the state of New South Wales ( NSW ) , Australia ( @ to @ ) .


ATLAS is an @-month multi-component , school-based program informed by self-determination theory and social cognitive theory .


The intervention consists of teacher professional development , enhanced school-sport sessions , researcher-led seminars , lunch-time physical activity mentoring sessions , pedometers for self-monitoring , provision of equipment to schools , parental newsletters , and a smartphone application and website .


Assessments were conducted at baseline and will be completed again at @ - and @-months from baseline .


Primary outcomes are body mass index ( BMI ) and waist circumference .


Secondary outcomes include BMI z-scores , body fat ( bioelectrical impedance analysis ) , physical activity ( accelerometers ) , muscular fitness ( grip strength and push-ups ) , screen-time , sugar-sweetened beverage consumption , resistance training skill competency , daytime sleepiness , subjective well-being , physical self-perception , pathological video gaming , and aggression .


Hypothesized mediators of behavior change will also be explored .


ATLAS is an innovative school-based intervention designed to improve the health behaviors and related outcomes of adolescent males in low-income communities .


Our recent work indicates that endogenous opioid activity influences analgesic responses to opioid medications .


This secondary analysis evaluated whether endogenous opioid activity is associated with degree of opioid analgesic adverse effects , and whether chronic pain status and sex affect these adverse effects .


Using a double-blind , randomized , placebo-controlled , crossover design , @ subjects with chronic low back pain and @ healthy controls participated in @ separate sessions , undergoing @ laboratory-evoked pain tasks ( ischemic and thermal ) after receiving placebo , naloxone , or morphine .


Endogenous opioid system function was indexed by the difference in pain responses between the placebo and naloxone conditions .


These measures were examined for associations with morphine-related adverse effects .


Chronic pain subjects reported significantly greater itching and unpleasant bodily sensations with morphine than controls ( P < @ ) .


Across groups , only @ of @ possible associations between adverse effects and blockade effects were significant .


For the ischemic task , higher endogenous opioid function was associated with greater itching ( visual analog scale -LSB- VAS -RSB- ; P < @ ) , numbness ( tolerance ; P < @ ) , dry mouth ( tolerance ; P < @ ) , and unpleasant bodily sensations ( VAS ; P < @ ) .


For the thermal task , higher endogenous opioid function was associated with greater numbness ( VAS ; P < @ ) and feeling carefree ( VAS ; P < @ ) .


There were no significant main or interaction effects of chronic pain status or sex on these findings .


No consistent relationships were observed between endogenous opioid function and morphine-related adverse effects .


This is in stark contrast to our previous observation of strong relationships between elevated endogenous opioid function and smaller morphine analgesic effects .


A new core biopsy needle for endoscopic ultrasound ( EUS ) - guided sampling has recently been developed .


The aim of this prospective multicenter study was to compare this needle with a standard needle in patients with solid pancreatic masses .


Consecutive patients with solid pancreatic masses referred to @ centers for EUS-guided sampling were included .


Each patient had two passes with a standard @G needle and a single pass with a @G core needle performed in a randomized order .


Samples from both needles were separately processed for liquid-based cytology and cell-block preparation and were assessed independently by two blinded expert pathologists .


The primary endpoint was the accuracy of the detection of malignancy .


The reference standard was based on further cytohistological analysis obtained under ultrasound or computed tomography scanning , endoscopic or surgical guidance , and/or by clinical follow-up with repeated imaging examinations for at least @ months .


The secondary endpoints were the rate of technical failure and the quality of the cytohistological samples obtained .


Of the @ patients included ( @ men ; mean age @ ) , @ % had final malignant diagnoses ( adenocarcinoma n = @ , @ % ) .


There was no difference between the needles in diagnostic accuracy ( standard needle @ % vs. core needle @ % ; P = @ ) or technical failure .


Both pathologists found the overall sample quality significantly better for the standard needle ( expert @ , P = @ ; expert @ , P = @ ) .


The diagnostic accuracy of EUS sampling for solid pancreatic masses using standard and core needles seems comparable but with a better overall histological sample quality for the former .


ClinicalTrial.gov identifier : NCT@ .


The purpose of this study was to evaluate the safety and efficacy of three different intravenous ( IV ) doses of palonosetron compared with placebo for the prevention of postoperative nausea and vomiting ( PONV ) in children undergoing dental rehabilitation under general anesthesia ( DRGA ) in the first @ hours after discharge .


A total of @ children who were classified with an American Society of Anesthesiologists physical status of I and II , between three and @ years old ( mean = @ years old ) , and undergoing DRGA were enrolled in this study .


The children were randomized to receive one of the three doses of palonosetron ( @ mg , @ mg , or @ mg ) or placebo immediately before induction of anesthesia .


Compared with placebo , the incidence of PONV was significantly lower in the palonosetron groups ( P < @ ) .


However , there were no statistically significant differences among the palonosetron groups regarding the number of children with PONV during all time periods after anesthesia ( P < @ ) .


A single @ mg intravenous dose of palonosetron is recommended for further evaluation , as it appears to be an effective dose for prevention of postoperative nausea and vomiting in children undergoing dental rehabilitation under general anesthesia .


To assess bacillus Calmette-Gurin maintenance treatment schedule for non-muscle invasive bladder cancer at @ years , using one-third of the full dose and fewer instillations every @ months or @ months .


This was a prospective , randomized , multicenter study .


All patients had an intermediate - or high-risk non-muscle invasive bladder cancer .


They received three weekly instillations of one-third dose bacillus Calmette-Gurin every @ months ( group I ) and two weekly instillations every @ months ( group II ) during @ years .


In the two schedules we assessed efficacy , tolerance , leukocyturia and prostate-specific antigen .


No significant difference was observed between the two groups for recurrence at @ , @ or @ months .


At @ years , tumor recurrence was observed in @ % and muscle invasion in @ % of cases .


Bacillus Calmette-Gurin tolerance was comparable - the adverse events score was @ in group I and @ in group II ( P = @ ) .


No statistical correlation was observed between the adverse events score over @ years , either for leukocyturia ( P = @ ) or prostate-specific antigen level ( P = @ ) .


Leukocyturia level was not significantly associated with tumor recurrence or progression .


One-third dose maintenance bacillus Calmette-Gurin is effective with no impact on tumor recurrence or muscle invasion .


Furthermore , there seems to be no difference in tumor response or side-effects between patients receiving two or three maintenance instillations every @ months or @ months .


In clinical practice , the use of leukocyturia or total prostate-specific antigen levels do not appear to be useful in predicting bacillus Calmette-Gurin toxicity .


To evaluate the usefulness of velocity ratio ( VR ) in patients with low gradient severe aortic stenosis ( LGSAS ) and preserved EF .


LGSAS despite preserved EF represents a clinically challenging entity .


Reliance on mean pressure gradient ( MPG ) may underestimate stenosis severity as has been reported in the context of paradoxical low flow , LGSAS .


On the other hand , grading of stenosis severity by aortic valve area ( AVA ) may overrate stenosis severity due to erroneous underestimation of LV outflow tract ( LVOT ) diameter , small body size or inconsistencies in cut-off values for severe stenosis .


We hypothesised that VR may have conceptual advantages over MPG and AVA , predict clinical outcomes and thereby be useful in the management of patients with LGSAS .


Patients from the prospective Simvastatin and Ezetimibe in Aortic Stenosis ( SEAS ) study with an AVA < @ cm ( @ ) , MPG@mmHg and EF@ % and asymptomatic at baseline were stratified according to VR with a cut-off value of @ .


Outcomes were evaluated according to aortic valve-related events and cardiovascular death .


Of @ patients with LGSAS , @ ( @ % ) had VR < @ suggesting severe and @ ( @ % ) had VR@ @ suggesting non-severe stenosis .


Aortic valve-related events ( mean follow-up @months ) were more frequent in patients with VR < @ ( @ % vs @ % ; p < @ ) as was cardiovascular death within the first @months ( p < @ ) .


In multivariable Cox regression analysis , MPG was the strongest independent predictor of aortic valve events ( p < @ ) followed by VR ( p < @ ) .


Adjusting AVA by VR increased predictive accuracy for aortic valve events ( area under the receiver operating curve @ ( @ % CI @ to @ ) vs @ ( @ % CI @ to @ ) for AVA , p = @ ) with net reclassification improvement calculated at @ ( @ % CI @ to @ , p < @ ) .


VR did not improve the prediction of clinical events by MPG .


In the difficult setting of LGSAS , VR shows a strong association with valve-related events and-although not outperforming MPG-may be particularly useful in guiding clinical management .


The objective was to assess the long-term safety profile of dual-release hydrocortisone ( DR-HC ) in patients with adrenal insufficiency ( AI ) .


Randomised , open-label , crossover trial of DR-HC or thrice-daily hydrocortisone for @ months each ( stage @ ) followed by two consecutive , prospective , open-label studies of DR-HC for @ months ( stage @ ) and @ months ( stage @ ) at five university clinics in Sweden .


Sixty-four adults with primary AI started stage @ , and an additional @ entered stage @ .


Patients received DR-HC @-@mg once daily and hydrocortisone @-@mg divided into three daily doses ( stage @ only ) .


Main outcome measures were adverse events ( AEs ) and intercurrent illness ( self-reported hydrocortisone use during illness ) .


In stage @ , patients had a median @ ( range , @-@ ) intercurrent illness events with DR-HC and @ ( @-@ ) with thrice-daily hydrocortisone .


AEs during stage @ were not related to the cortisol exposure-time profile .


The percentage of patients with one or more AEs during stage @ ( @ % with DR-HC ; @ % with thrice-daily hydrocortisone ) decreased during stage @ , when all patients received DR-HC ( @ % in the first @ months ; @ % in the second @ months ) .


In stages @-@ combined , @ patients experienced @ serious AEs , equating to @ serious AEs/@ patient-years of DR-HC exposure .


This long-term prospective trial is the first to document the safety of DR-HC in patients with primary AI and demonstrates that such treatment is well tolerated during @ consecutive months of therapy .


Low-fat and low-carbohydrate weight-loss diets can have a beneficial effect on longitudinal measures of blood pressure and blood lipids .


We aimed to assess longitudinal changes in blood pressure and blood lipids in a population of premenopausal women .


We hypothesized that results may differ by level of adherence to the respective diet protocol and baseline presence of hypertension or hyperlipidemia .


Overweight or obese premenopausal women were randomized to a low-fat ( n = @ ) or low-carbohydrate ( n = @ ) diet .


As part of the @-week Lifestyle Eating and Fitness ( LEAF ) intervention trial , we fit linear mixed models to determine whether a change in outcome differed by treatment arm .


Within-group trends in blood pressure and blood lipids did not differ ( p > @ ) .


Across study arms , there was a significant decrease in systolic blood pressure ( SBP , @mm Hg , p = @ ) over time , but diastolic blood pressure ( DBP ) did not change significantly over the course of the study .


Blood lipids ( total cholesterol -LSB- TC -RSB- , low-density lipoproteins -LSB- LDL -RSB- , and high-density lipoproteins -LSB- HDL -RSB- ) all exhibited nonlinear trends over time ( p < @ ) ; each decreased initially but returned to levels comparable to baseline by study conclusion ( p > @ ) .


We observed a decline in SBP among women who were hypertensive at baseline ( p < @ ) , but hypercholesterolemia at baseline did not affect trends in blood lipids ( p > @ ) .


Our results support that dietary interventions may be efficacious for lowering blood pressure and blood lipids among overweight or obese premenopausal women .


However , a decrease in SBP was the only favorable change that was sustained in this study population .


These changes can be maintained over the course of a @-year intervention , yet changes in blood lipids may be less sustainable .


Intrafraction tumour motion in helical tomotherapy was investigated by comparing pre - and mid-fraction CT scans in patients with early non-small cell lung carcinoma ( NSCLC ) to assess the efficacy of a @-mm margin around gross tumour volumes ( GTVs ) in stereotactic body radiation therapy ( SBRT ) .


Thirty patients with early-stage NSCLC received SBRT in four or five fractions for a total of @ treatments .


A slow positron emission tomography/CT scan was fused with the simulation CT to determine the GTV .


A planning target volume was created by placing an isotropic margin of @mm around the GTV .


Data were retrospectively analyzed to assess translational tumour positional changes along the x , y and z axes and vector changes in millimeters from the pretreatment megavoltage ( MV ) - CT to the mid-fraction MV-CT .


Average movements for all @ treatment days along the x , y and z axes were @ , -@ and @ mm , respectively .


Average movements for each patient along the x , y and z axes were @ , -@ and @ mm , respectively .


Average vector displacement was @ mm for all treatment days and @ mm for each patient .


Of @ treatments , @ ( @ % ) fell within @ mm in all axes .


The addition of a @-mm margin to the GTV for patients receiving SBRT for NSCLC using tomotherapy is adequate to account for tumour movement .


Mid-fraction CT scans proved to be valuable in assessing intrafraction tumour motion .


Standard varenicline tartrate dosing was formulated to avoid adverse effects ( primarily nausea ) , but some patients may be underdosed .


To our knowledge , no evidence-based guidance exists for physicians considering increasing varenicline dose if there is no response to the standard dosage .


To determine whether increasing varenicline dose in patients showing no response to the standard dosage improves treatment efficacy .


In a double-blind randomized placebo-controlled trial , @ smokers attending a stop smoking clinic commenced varenicline use @ weeks before their target quit date ( TQD ) .


Two hundred participants reporting no strong nausea , no clear reduction in smoking enjoyment , and less than @ % reduction in their baseline smoking on day @ received additional tablets of varenicline or placebo .


All participants began standard varenicline tartrate dosing , gradually increasing to @ mg/d .


Dose increases of twice-daily varenicline ( @ mg ) or placebo took place on days @ , @ , and @ ( up to a maximum of @ mg/d ) .


Participants rated their smoking enjoyment during the prequit period and withdrawal symptoms weekly for the first @ weeks after the TQD .


Continuous validated abstinence rates were assessed at @ , @ , and @ weeks after the TQD .


The dose increase reduced smoking enjoyment during the prequit period , with mean ( SD ) ratings of @ ( @ ) for varenicline vs @ ( @ ) for placebo ( P = @ ) .


It had no effect on the mean ( SD ) frequency of urges to smoke at @ week after the TQD , their strength , or the severity of withdrawal symptoms : these ratings for varenicline vs placebo were @ ( @ ) vs @ ( @ ) ( P = @ ) , @ ( @ ) vs @ ( @ ) ( P = @ ) , and @ ( @ ) vs @ ( @ ) ( P = @ ) , respectively .


The dose increase also had no effect on smoking cessation rates for varenicline vs placebo at @ week ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- , P = @ ) , @ weeks ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- , P = @ ) , and @ weeks ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- , P = @ ) after the TQD .


There was significantly more nausea ( P < @ ) and vomiting ( P < @ ) reported in the varenicline arm than in the placebo arm .


Increasing varenicline dose in smokers with low response to the drug had no significant effect on tobacco withdrawal symptoms or smoking cessation .


Physicians often consider increasing the medication dose if there is no response to the standard dosage .


This approach may not work with varenicline .


To assess the efficacy of the cytoprotective neuropeptide cortexin in the complex treatment in acute and early rehabilitation stages of ischemic stroke ( II ) .


A multicenter prospective double-blind placebo-controlled trial has been carried out .


Two hundreds and seventy-two patients with II have been enrolled in the trial .


Cortexin was administered in low doses ( @ mg three times a day intramuscular , using the following schemes : group @ : @ courses of cortexin ; group @ : @ course of cortexin with the following course of placebo ; group @ : two courses of placebo .


The duration of treatment was @ days .


Patients were examined during @ visits using clinical tests and instrumental methods .


High efficacy and safety of cortexin in the complex treatment of patients with II has been shown .


The best therapeutic effect was seen in group @ ( two @-day courses of cortexin ) .


The results were confirmed by the pharmacoeconomic analysis of treatment tactics based on the estimation of `` net monetary benefit '' .


Cortexin is recommended for treatment and rehabilitation of patients with II .


To compare postoperative blood loss under different negative pressures of drainage after total hip arthroplasty for the treatment of femoral neck fractures .


From January @st to December @th @ , @ patients with femoral neck fractures treated with total hip arthroplasty were randomly divided into two groups : high negative pressure drainage group and low negative pressure drainage group .


In high negative pressure drainage group , there were @ cases including @ males and @ females , with a mean age of ( @ @ ) years old , and the patients were treated with @ kPa negative pressure of drainage .


In the low negative pressure drainage group , there were @ cases including @ males and @ females , with an average age of ( @ @ ) years old , and the patients were treated with @ kPa negative pressure of drainage .


The amount of total drainage , total blood loss , and hemoglobin change were compared between these two groups .


All the patients got primary healing without infections .


In high negative pressure drainage group , the change of hemoglobin was ( @ @ ) g/L , total blood loss was ( @,@ @ ) ml and the drainage volume was ( @ @ ) ml ; while in low negative pressure drainage group , the results were ( @ @ ) g/L , ( @ @ ) ml and ( @ @ ) ml separately .


All the results in high negative pressure drainage group were higher than those in the other group .


Three days after operation , the change of hemoglobin was ( @ @ ) g/L and total blood loss was ( @,@ @ ) ml ; while in low negative pressure drainage group , the changes of hemoglobin was ( @ @ ) g/L and total blood loss was ( @,@ @ ) ml ; there were no statistically significant differences between two groups .


When placing drainage devices after total hip arthroplasty for the treatment of femoral neck fractures , the level of negative pressure should be chosen according to preoperative level of hemoglobin and HCT in patients .


For old patients with femoral neck fracture , low negative pressure is more suitable .


One objective of this study was to assess the effects of laughter on the psychological , immunological and physiological systems of the body .


Another objective was to introduce the Laughing Qigong Program ( LQP ) , as a method of standardization for simulated laughter interventions .


A randomized , prospective , experimental study of the LQP was conducted in a group of adolescents ( n = @ ) in Taiwan .


During study-hall sessions , experimental subjects ( n = @ ) attended the LQP for eight-weeks .


Simultaneously , control subjects ( n = @ ) read or did their homework .


All subjects were tested before and after the intervention on the following : Rosenberg Self-Esteem scale ( RSE ) , Chinese Humor Scale ( CHS ) and Face Scale ( FS ) as psychological markers ; saliva cortisol ( CS ) as an immunological marker ; blood pressure ( BP ) , heart rate ( HR ) , and heart rate variability ( HRV ) as physiological markers of the body 's response to stress .


Mood states ( FS ) were measured before/after each LQP session .


Mood states ( p = @ ) and humor ( p = @ ; p = @ ) improved in the experimental group ; no significant changes were found in the controls ( p = @ ; p = @ ) .


The immunological marker of stress , cortisol levels , decreased significantly for those who participated in the LQP ( p = @ ) , suggesting lower levels of stress after completion of the program .


The LQP is a non-pharmacological and cost-effective means to help adolescents mitigate stresses in their everyday life .


Neisseria meningitidis serogroup B ( MnB ) is a major cause of invasive meningococcal disease in infants .


A conserved , surface-exposed lipoprotein , LP@ ( a factor H-binding protein -LSB- fHBP -RSB- ) , is a promising MnB vaccine target .


A bivalent , recombinant vaccine targeting the fHBP ( rLP@ ) of MnB was developed .


This phase @/@ clinical study was designed to assess the immunogenicity , safety , and tolerability of a @-dose series of the rLP@ vaccine at @ - , @ - , @ - , or @-g dose levels in vaccine-naive infants when given with routine childhood vaccines .


The study was to consist of two phases : a single-blind sentinel phase and an open-label full enrollment phase .


During the sentinel phase , randomization of subjects to the next higher dose was delayed pending a @-day safety review of dose @ of the preceding dose cohort .


The full enrollment phase was to occur after completion of the sentinel phase .


Local reactions were generally mild and adverse events infrequent ; however , after only @ infants were randomized into the study , fever rates were @ % and @ % in subjects receiving one @ - or @-g rLP@ dose , respectively .


Most fevers were < @ C. Only @ subjects in the @-g group and @ subject in the @-g group experienced fevers > @ C ; no fevers were > @ C. Due to these high fever rates , the study was terminated early .


No immunogenicity data were collected .


This report discusses the safety and acceptability of rLP@ in infants after one @ - or @-g dose .


Due to the high fever rate experienced in the @ - and @-g groups , rLP@ in the current formulation may not be acceptable for infants .


To compare effects of integrated treatment traditional Chinese medicine and Western medicine ( TCM-WM ) and simple western medicine on TCM clincal symptoms in the patient of AIDS with pulmonary inflammation .


A multicenter randomized controlled trials of @ subjects evaluated the effects of clinical symptoms of AIDS with pulmonary inflammation of TWO regimens : the TCM-WM group ( n = @ ) and western medicine treatment group ( n = @ ) , while incidence of TCM symptoms in different time points in two groups were analyzed .


Twenty eight days after treatment , the cured and markedly effective rate of TCM symptoms in the TCM-WM group significantly exceeding that in the western medicine treatment group ( cured and markedly effective rate significant efficiency @ % vs @ % ) , while the incidence rate for the TCM symptoms of fever and headache in the TCM-WM group was significantly lower than that in western medicine group .


The integrated treatment of traditional Chinese medicine and Western medicine helps to alleviate the TCM clinical symptoms of AIDS with pulmonary inflammation .


We evaluated the effects of cognitive speed of processing training ( SOPT ) on the development of additional Instrumental Activities of Daily Living ( IADL ) difficulties and the reduction of depressive symptoms in the Iowa Healthy and Active Minds Study ( IHAMS ) .


Six hundred eighty-one patients were randomized to @ groups : @ hr of on-site SOPT , @ hr of on-site SOPT plus @ hr of boosters , @ hr of at-home SOPT , or @ hr of on-site attention-control ( crossword puzzles ) .


Developing additional difficulties with IADLs and reductions in depressive symptoms @ year later were evaluated using multiple logistic regression .


The on-site SOPT with boosters group had reduced odds of developing additional difficulties with IADLs ( adjusted odds ratio -LSB- AOR -RSB- = @ , p = @ ) compared with attention-controls .


The on-site SOPT with boosters group also had increased odds of reduced depressive symptom levels ( AOR = @ , p = @ ) compared with attention-controls .


These findings provide evidence that SOPT transfers beyond the cognitive skills trained to meaningful downstream improvements in the lives of middle-aged and older adults .


The success of damage-control surgery ( DCS ) for the treatment of trauma has led to its use in other surgical problems such as abdominal sepsis .


Previous studies using direct peritoneal resuscitation ( DPR ) for the treatment of trauma have yielded promising results .


We present the results of the application of this technique to patients experiencing abdominal sepsis .


We enrolled @ DCS patients during a @ year-period ( January @ to December @ ) into a propensity-matched study to evaluate the utility of using DPR in addition to standard resuscitation .


DPR consisted of peritoneal lavage with @ % DELFLEX , and abdominal closure was standardized across both groups .


Patients were matched using Acute Physiology and Chronic Health Evaluation II ( APACHE II ) variables .


Univariate and multivariate analyses were performed .


There were no differences between the control and experimental groups with regard to age , sex , ethnicity , or APACHE II at @ hours .


Indications for damage control included pancreatitis , perforated hollow viscous , bowel obstruction , and ischemic enterocolitis .


Patients undergoing DPR had both a higher rate of ( @ % vs. @ % , p < @ ) and a shorter time to definitive fascial closure ( @ -LSB- @ -RSB- days vs. @ -LSB- @ -RSB- days , p < @ ) .


DPR patients had a decreased APACHE II and Sequential Organ Failure Assessment ( SOFA ) score compared with the controls at @ hours .


In addition , DPR patients had fewer abdominal complications compared with the controls ( RR , @ ; @ % confidence interval , @-@ @ ; p = @ ) .


Ventilator days and intensive care unit length of stay were both significantly reduced in the DPR group .


The DPR group showed a lower overall mortality at @ days ( @ % vs. @ % , p = @ ) .


DPR reduces time to definitive abdominal closure , increases primary fascial closure , and reduces intra-abdominal complications following DCS .


DPR may also attenuate progressive physiologic injury as demonstrated by a reduction in @-hour intensive care unit severity scores .


As a result , DPR following DCS may afford better outcomes to patients experiencing shock .


Therapeutic study , level III .


The importance of vitamin D on bone health and osteoporosis was studied by many researchers .


The main role of the Vitamin D is to absorb calcium and phosphate and increase bone mineralization .


Older people are at an increased risk of the inadequate vitamin D production in the skin because of lower sun exposure and reduced ability of the skin to synthesize vitamin D.


The aim of this clinical trial was to evaluate the efficacy and tolerability of short-term ( @ weeks ) low energy UVB irradiation in postmenopausal women with osteoporosis using bone mineral density and bone turnover markers .


A three-month , single-blinded , randomized , placebo-controlled clinical trial was conducted at the University hospital in Daegu , Republic of Korea .


Fifty-two postmenopausal Korean women ( older than @ years ) with osteoporosis were randomly allocated to have either low energy UVB or placebo for @ minutes a day for two weeks of treatment during winter .


Laboratory analysis and physical examination before and @ , @ and @ weeks after treatment were carried out and BMD was measured before and @ and @ weeks after treatment .


The effects of time and treatment interaction between these two groups were evaluated by repeated-measure two-factor analysis , and subgroup analysis was performed to examine UVB effect on the vitamin D insufficient group -LSB- serum @ ( OH ) D@ concentration < @ ng/mL -RSB- .


In vitamin D insufficient group , the effect of UVB irradiation on vitamin D and bone ALP as well as additional benefit on bone formation was confirmed .


The vitamin D insufficient group showed statistically significant increment in serum @ ( OH ) D@ compared with the normal group ( p < @ ) .


However , there was no significant difference between two groups in the other bone turnover markers , such as serum calcium , PTH-C , serum osteocalcin , serum CTX and BMD .


Low-energy-short-term UVB radiation for postmenopausal women may be of use in vitamin D synthesis .


There was a modest benefit in change of bone ALP especially in women with the insufficient vitamin D.


This phase II study evaluated the synthetic DNA-based immunomodulator and Toll-like receptor @ agonist MGN@ as maintenance treatment in metastatic colorectal carcinoma ( mCRC ) .


Fifty-nine patients with mCRC and disease control after standard first-line chemotherapy were randomised to MGN@ @mg ( N = @ ) or placebo ( N = @ ) .


The hazard ratio ( HR ) for the primary endpoint -LSB- progression-free survival ( PFS ) from the start of maintenance -RSB- was @ ( @ % CI @-@ @ ; P = @ ) and @ ( @ % CI @-@ @ ; P = @ ) by independent and investigator review , respectively .


MGN@ significantly improved PFS measured from the start of induction therapy versus placebo on independent ( HR @ ; @ % CI @-@ @ ; P = @ ) and investigator review ( HR @ ; @ % CI @-@ @ ; P = @ ) .


Overall survival ( OS ) data remain immature ( HR @ % ; @ % CI @-@ @ ; P = @ ) with @/@ patients alive after a medium follow-up of > @months .


Retrospective subgroup analysis showed a significant effect of MGN@ on PFS versus placebo in patients with greater than median tumour size reduction and normalised carcinoembryonic antigen concentrations following induction therapy , and in patients with elevated activated NKT cells@ @ % .


Adverse events were mild to moderate and limited to injection-site reactions or linked to general immune system activation .


MGN@ maintenance treatment was well tolerated and appears to induce durable and prolonged PFS and disease control in a subgroup of patients with mCRC following induction therapy .


Activated NKT cells may be a predictive biomarker for selecting patients likely to benefit more from MGN@ .


Rheumatoid Arthritis ( RA ) is one of the most common autoimmune diseases , affecting approximately @ % of the UK adult population .


Patients suffer considerable pain , stiffness and swelling and can sustain various degrees of joint destruction , deformity , and significant functional decline .


In addition , the economic burden due to hospitalisation and loss of employment is considerable , with over @ % of patients being work-disabled within @years of diagnosis .


Despite several biologic disease modifying anti-rheumatic drugs ( bDMARD ) now available , there is a lack of data to guide biologic sequencing .


In the UK , second-line biologic treatment is restricted to a single option , rituximab .


The aim of the SWITCH trial is to establish whether an alternative-mechanism-TNF-inhibitor ( TNFi ) or abatacept are as effective as rituximab in patients with RA who have failed an initial TNFi drug .


SWITCH is a pragmatic , phase IV , multi-centre , parallel-group design , open-label , randomised , controlled trial ( RCT ) comparing alternative-mechanism-TNFi and abatacept with rituximab in patients with RA who have failed an initial TNFi drug .


Participants are randomised in a @:@:@ ratio to receive alternative mechanism TNFi , ( monoclonal antibodies : infliximab , adalimumab , certolizumab or golimumab or the receptor fusion protein , etanercept ) , abatacept or rituximab during the interventional phase ( from randomisation up to week @ ) .


Participants are subsequently followed up to a maximum of @weeks , which constitutes the observational phase .


The primary objective is to establish whether an alternative-mechanism-TNFi or abatacept are non-inferior to rituximab in terms of disease response at @weeks post randomisation .


The secondary objectives include the comparison of alternative-mechanism-TNFi and abatacept to rituximab in terms of disease response , quality of life , toxicity , safety and structural and bone density outcomes over a @-month period ( @weeks ) and to evaluate the cost-effectiveness of switching patients to alternative active therapies compared to current practice .


SWITCH is a well-designed trial in this therapeutic area that aims to develop a rational treatment algorithm to potentially inform personalised treatment regimens ( as opposed to switching all patients to only one available ( and possibly unsuccessful ) therapy ) , which may lead to long-term improved patient outcomes and gains in population health .


There is a need for evidence of the clinical effectiveness of minimally invasive surgery for the treatment of esophageal cancer , but randomized controlled trials in surgery are often difficult to conduct .


The ROMIO ( Randomized Open or Minimally Invasive Oesophagectomy ) study will establish the feasibility of a main trial which will examine the clinical and cost-effectiveness of minimally invasive and open surgical procedures for the treatment of esophageal cancer .


A pilot randomized controlled trial ( RCT ) , in two centers ( University Hospitals Bristol NHS Foundation Trust and Plymouth Hospitals NHS Trust ) will examine numbers of incident and eligible patients who consent to participate in the ROMIO study .


Interventions will include esophagectomy by : ( @ ) open gastric mobilization and right thoracotomy , ( @ ) laparoscopic gastric mobilization and right thoracotomy , and ( @ ) totally minimally invasive surgery ( in the Bristol center only ) .


The primary outcomes of the feasibility study will be measures of recruitment , successful development of methods to monitor quality of surgery and fidelity to a surgical protocol , and development of a core outcome set to evaluate esophageal cancer surgery .


The study will test patient-reported outcomes measures to assess recovery , methods to blind participants , assessments of surgical morbidity , and methods to capture cost and resource use .


ROMIO will integrate methods to monitor and improve recruitment using audio recordings of consultations between recruiting surgeons , nurses , and patients to provide feedback for recruiting staff .


The ROMIO study aims to establish efficient methods to undertake a main trial of minimally invasive surgery versus open surgery for esophageal cancer .


Posttransplant anemia is associated with an increased risk of congestive heart failure , left ventricular hypertrophy , and death .


The purpose of this study was to evaluate the effect of long-acting erythropoietin-stimulating agents on anemia after kidney transplant .


In @ kidney transplant recipients , @ anemic patients ( @ % ) with stable graft function were followed at the Hamed Al-Essa Organ Transplant Centre ( Kuwait ) and were assessed for anemia .


We enrolled @ patients into this open-label study in @ groups : group @ had treatment with darbepoetin alfa ( @ patients ) and group @ had continuous erythropoietin receptor activator ( @ patients ) .


Patient age correlated negatively with serum iron level .


Serum ferritin correlated negatively with hemoglobin level @ months after transplant but not at time of transplant .


Most patients were women who received their grafts from male donors .


The @ groups were comparable in frequency of rejection and mean hemoglobin and serum albumin levels at @ , @ , @ , and @ months after transplant .


There was no difference between the @ groups in renal function ( estimated glomerular filtration rate ) ; posttransplant complications such as new-onset diabetes after transplant , hypertension , serious bacterial infections , or patient and graft outcomes .


Anemia is an important problem after kidney transplant , and iron use is suboptimal in kidney transplant recipients .


Darbepoetin alfa and continuous erythropoietin receptor activator had comparable positive results .


This study evaluates persistence and severity of docetaxel-induced neuropathy ( peripheral neuropathy ( PN ) ) and impact on health related quality of life in survivors from early-stage breast cancer .


One thousand and thirty-one patients with early-stage breast cancer , who received at least one cycle of docetaxel and provided information on PN during treatment , completed questionnaires on PN as an outcome ( Common Toxicity Criteria ( CTC ) scores , European Organisation for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy @ ( EORTC CIPN@ ) and EORTC Quality of Life Questionnaire ( QLQ ) - C@ ) after @-@years .


Upon completion of docetaxel treatment , @ patients ( @ % ) reported PN , grades @-@ .


PN persisted for @-@years among @ ( @ % ) while PN regressed to grades @-@ among @ ( @ % ) .


Among @ patients ( @ % ) without PN , @ ( @ % ) developed PN @-@years later while @ ( @ % ) stayed free from PN .


Significant risk factors for persistent PN were age @ ( p = @ ) , maximum grade of PN during docetaxel treatment ( p < @ ) , persistent muscle and joint pain ( p < @ ) , stomatitis ( p = @ ) and fatigue ( p = @ ) .


Persistent PN had a significant negative correlation with health-related quality of life ( HRQOL ) , functional scales and symptom scales .


Overall , @ % of breast cancer survivors treated with docetaxel report PN @-@years after treatment with a significant negative impact on HRQOL .


A multivariable training has a positive impact on balance skills and risk of injury .


To date the effect of this training using the Nintendo Wii balance board in sportive people has not yet been investigated .


The aim of this study was to investigate whether training with the Nintendo Wii balance board can improve balance skills .


@ people were randomized into a control and an intervention group each with @ people who performed a unilateral stance test with eyes open and closed as well as the star excursion balance test before and after the intervention .


The control group completed their usual sports and the intervention group an adjunct training with the Nintendo Wii balance board for @ weeks .


Adjunct Training using the Nintendo Wii Balance Board did not improve sportive people 's balance skills significantly .


The intervention group , however , attained better results in the star excursion balance test , whereas the control group did not show any changes .


The unilateral stance tests did not provide significant differences before and after training within both groups .


The use of the Nintendo Wii balance board should be further investigated by employing individual difficulty levels .


Although some studies suggest that art therapy may be useful in the treatment of negative symptoms of schizophrenia , a recent large trial of group art therapy found no clinical advantage over standard care , but the study population was heterogeneous and uptake of the intervention was poor .


This study aimed to investigate whether art therapy was more effective for specific subgroups of patients .


Secondary analysis of data from a randomised controlled trial of group art therapy as an adjunctive treatment for schizophrenia ( n = @ ) versus standard care alone ( n = @ ) .


Positive and Negative Syndrome Scale scores at @ months were compared between trial arms .


Interaction between intervention effect and different subgroups , including those with more severe negative symptoms of schizophrenia , and those who expressed a preference for art therapy prior to randomisation , was tested using a linear mixed model .


The clinical effectiveness of group art therapy did not significantly differ between participants with more or less severe negative symptoms -LSB- interaction for difference in PANSS = @ , @ % CI ( -@ to @ ) , P = @ -RSB- , or between those who did and did not express a preference for art therapy -LSB- interaction = @ , @ % CI ( -@ to @ ) , P = @ -RSB- .


None of the other exploratory subgroups suggested differences in intervention effect .


There was no evidence of greater improvement in clinical symptoms of schizophrenia for those with more severe negative symptoms or those with a preference for art therapy .


Identification of patients with schizophrenia who may benefit most from group art therapy remains elusive .


To investigate the feasibility and potential efficacy of the Nintendo Wii for balance rehabilitation after stroke .


Phase II , single-blind , randomized controlled trial .


Inpatient rehabilitation facility .


Thirty adults ( mean age @ ( @ ) years ) undergoing inpatient rehabilitation who were less than three months post-stroke and able to stand unsupported .


Participants were allocated to a Balance Group , using the ` Wii Fit Plus ' in standing , or Upper Limb Group , using the ` Wii Sports/Sports Resort ' in sitting .


Both groups undertook three @ minute sessions per week over two to four weeks in addition to standard care .


The primary focus was feasibility , addressed by recruitment , retention , adherence , acceptability and safety .


Efficacy was evaluated by balance , mobility and upper limb outcomes .


Twenty-one percent of individuals screened were recruited and @ % ( n = @ ) of eligible people agreed to participate .


Study retention and session adherence was @ % and > @ % , respectively , at two weeks ; dropping to @ % and @ % at four weeks due to early discharge .


All participants reported enjoying the sessions and most felt they were beneficial .


No major adverse events occurred .


Wii use by the Balance Group was associated with trends for improved balance , with significantly greater improvement in outcomes including the Step Test and Wii Balance Board-derived centre of pressure scores .


The Upper Limb Group had larger , non-significant changes in arm function .


A Wii-based approach appears feasible and promising for post-stroke balance rehabilitation .


A larger randomized controlled trial is recommended to further investigate efficacy .


Poor prognosis patients with bulky stage III locally advanced non-small-cell lung cancer may not be offered concurrent chemoradiotherapy ( CRT ) .


Following a phase III trial concerning the effect of palliative CRT in inoperable poor prognosis patients , this analysis was performed to explore how tumor size influenced survival and health-related quality of life ( HRQOL ) .


A total of @ poor prognosis patients recruited in a randomized clinical trial received four courses intravenous carboplatin day @ and oral vinorelbine day @ and @ , at @-week intervals .


The experimental arm ( N = @ ) received radiotherapy with fractionation @ Gy/@ , starting at the second chemotherapy course .


This subset study compares outcomes in patients with tumors larger than @ cm ( N = @ ) versus tumors @ cm or smaller ( N = @ ) .


Among those with tumors larger than @ cm , the median overall survival in the chemotherapy versus CRT arm was @ and @ months , respectively ( p = @ ) .


The @-year survival was @ % and @ % , respectively ( p = @ ) .


Except for a temporary decline during treatment , HRQOL was maintained in the CRT arm , regardless of tumor size .


Among those who did not receive CRT , patients with tumors larger than @ cm experienced a gradual decline in the HRQOL .


The CRT group had significantly more esophagitis and hospitalizations because of side effects regardless of tumor size .


In patients with poor prognosis and inoperable locally advanced non-small-cell lung cancer , large tumor size should not be considered a negative predictive factor .


Except for performance status @ , patients with tumors larger than @ cm apparently benefit from CRT .


To evaluate the role of intravitreal aflibercept injection as a treatment for eyes with chronic central serous chorioretinopathy ( CSCR ) .


This prospective pilot study enrolled @ patients with chronic CSCR who received a @-month treatment regimen of intravitreal aflibercept .


Patients were followed with monthly Early Treatment of Diabetic Retinopathy Study ( ETDRS ) best-corrected visual acuity ( BCVA ) and spectral domain optical coherence tomography ( SD-OCT ) with enhanced depth imaging .


All patients were men between @ and @years ( median @ ) .


Subfoveal fluid was present on OCT for a median duration of @months ( range @-@months ) prior to treatment .


Baseline BCVA ranged from @/@ to @/@ ( median @/@ ) with a mean of @ ( SD = @ ) ETDRS letters .


No patients experienced serious ocular or systemic adverse events over the course of the study .


Post-treatment BCVA ranged from @/@ to @/@ ( median @/@ ) , with a mean of @ ( SD = @ ) ETDRS letters ( p = @ ) .


At baseline , three patients ( @ % ) had BCVA of @/@ versus seven patients ( @ % ) at the conclusion of the study .


Two patients gained at least @ ETDRS letters and no patients lost more than @ ETDRS letters .


Six of @ patients ( @ % ) had complete resolution of subfoveal fluid .


Mean central macular thickness decreased from @m ( SD = @m ) to @m ( SD = @m ) ( p = @ ) , and mean subfoveal fluid decreased from @m ( SD = @m ) to @m ( SD = @m ) ( p = @ ) .


Mean choroidal thickness decreased from @m ( SD = @m ) to @m ( SD = @m ) ( p = @ ) .


Intravitreal aflibercept was well tolerated over a @-month treatment course for chronic CSCR .


No change was observed in visual acuity metrics .


Anatomic trends may suggest some morphological activity , but larger controlled trials are needed .


Serum infliximab trough levels correlate with efficacy ; dose escalation is often beneficial in patients with Crohn 's disease who stop responding to infliximab treatment .


To carry out a post hoc analysis of A Crohn 's Disease Clinical Trial Evaluating Infliximab in a New Long-term Treatment Regimen I ( ACCENT I ) to evaluate the association between serum infliximab trough levels and C-reactive protein ( CRP ) after @weeks of induction treatment with durable sustained long-term response ( Crohn 's Disease Activity Index decrease @ points and reduction @ % from baseline ) .


ACCENT I was a multicentre , randomised , placebo-controlled study .


Week @ trough levels and CRP percentage decrease from baseline to week @ were compared between patients with and without durable sustained response through week @ .


Sensitivity and specificity were determined to predict durable sustained response .


Receiver operating characteristic ( ROC ) curves identified optimal cut-off points ; logistic regression determined ORs .


After induction with @mg/kg infliximab , @ % ( @/@ ) and @ % ( @/@ ) of patients sustained week @ response to infliximab @ or @mg/kg , respectively , administered every @weeks without dose escalation , through week @ .


Median week @ trough levels of patients with and without durable sustained response to infliximab @mg/kg were @ and @ g/mL , respectively ( p = @ ) .


Optimal predictors of durable sustained response to maintenance infliximab @mg/kg were week @ trough level @ g/mL and @ % CRP decrease ( ORs ( @ % CI ) , @ ( @ to @ ) and @ ( @ to @ ) ) , respectively , in patients with raised baseline CRP ( > @ mg/L ) ; area under the ROC curve was @ for both predictors .


A @ g/mL week @ infliximab serum level did not predict durable sustained response to @mg/kg maintenance infliximab .


Patients with durable sustained response to maintenance infliximab @mg/kg had higher postinduction trough levels than patients without durable sustained response .


Serum infliximab trough levels @ g/mL and @ % CRP decrease were significantly associated with durable sustained response .


Intimate partner violence ( IPV ) and HIV are important and interconnected public health concerns .


While it is recognized that they share common social drivers , there is limited evidence surrounding the potential of community interventions to reduce violence and HIV risk at the community level .


The SASA !


study assessed the community-level impact of SASA !


, a community mobilization intervention to prevent violence and reduce HIV-risk behaviors .


From @ to @ a pair-matched cluster randomized controlled trial ( CRT ) was conducted in eight communities ( four intervention and four control ) in Kampala , Uganda .


Cross-sectional surveys of a random sample of community members , @ - to @-years old , were undertaken at baseline ( n = @,@ ) and four years post intervention implementation ( n = @,@ ) .


Six violence and HIV-related primary outcomes were defined a priori .


An adjusted cluster-level intention-to-treat analysis compared outcomes in intervention and control communities at follow-up .


The intervention was associated with significantly lower social acceptance of IPV among women ( adjusted risk ratio @ , @ % confidence interval ( CI ) @ to @ ) and lower acceptance among men ( @ , @ % CI @ to @ ) ; significantly greater acceptance that a woman can refuse sex among women ( @ , @ % CI @ to @ ) and men ( @ , @ % CI @ to @ ) ; @ % lower past year experience of physical IPV among women ( @ , @ % CI @ to @ ) ; and lower levels of past year experience of sexual IPV ( @ , @ % CI @ to @ ) .


Women experiencing violence in intervention communities were more likely to receive supportive community responses .


Reported past year sexual concurrency by men was significantly lower in intervention compared to control communities ( @ , @ % CI @ to @ ) .


This is the first CRT in sub-Saharan Africa to assess the community impact of a mobilization program on the social acceptability of IPV , the past year prevalence of IPV and levels of sexual concurrency .


SASA !


achieved important community impacts , and is now being delivered in control communities and replicated in @ countries .


It is uncertain whether bridging anticoagulation is necessary for patients with atrial fibrillation who need an interruption in warfarin treatment for an elective operation or other elective invasive procedure .


We hypothesized that forgoing bridging anticoagulation would be noninferior to bridging with low-molecular-weight heparin for the prevention of perioperative arterial thromboembolism and would be superior to bridging with respect to major bleeding .


We performed a randomized , double-blind , placebo-controlled trial in which , after perioperative interruption of warfarin therapy , patients were randomly assigned to receive bridging anticoagulation therapy with low-molecular-weight heparin ( @ IU of dalteparin per kilogram of body weight ) or matching placebo administered subcutaneously twice daily , from @ days before the procedure until @ hours before the procedure and then for @ to @ days after the procedure .


Warfarin treatment was stopped @ days before the procedure and was resumed within @ hours after the procedure .


Follow-up of patients continued for @ days after the procedure .


The primary outcomes were arterial thromboembolism ( stroke , systemic embolism , or transient ischemic attack ) and major bleeding .


In total , @ patients were enrolled , with @ assigned to receive no bridging therapy and @ assigned to receive bridging therapy .


The incidence of arterial thromboembolism was @ % in the no-bridging group and @ % in the bridging group ( risk difference , @ percentage points ; @ % confidence interval -LSB- CI -RSB- , -@ to @ ; P = @ for noninferiority ) .


The incidence of major bleeding was @ % in the no-bridging group and @ % in the bridging group ( relative risk , @ ; @ % CI , @ to @ ; P = @ for superiority ) .


In patients with atrial fibrillation who had warfarin treatment interrupted for an elective operation or other elective invasive procedure , forgoing bridging anticoagulation was noninferior to perioperative bridging with low-molecular-weight heparin for the prevention of arterial thromboembolism and decreased the risk of major bleeding .


( Funded by the National Heart , Lung , and Blood Institute of the National Institutes of Health ; BRIDGE ClinicalTrials.gov number , NCT@ . )


The Strategic Timing of AntiRetroviral Treatment ( START ) trial has recruited antiretroviral-nave individuals with high CD@ cell counts from all regions of the world .


We describe the distribution of cardiovascular disease ( CVD ) risk factors , overall and by geographical region , at study baseline .


The distribution of CVD risk factors was assessed and compared by geographical region among START participants who had a baseline electrocardiogram ( n = @ ; North America , @ % ; Europe/Australia/Israel , @ % ; South America , @ % ; Asia , @ % ; Africa , @ % ; median age @ years ; @ % female ) .


About @ % ( n = @ ) of the participants had at least one CVD risk factor and @ % ( n = @ ) had two or more .


The most common CVD risk factors were current smoking ( @ % ) , hypertension ( @ % ) and obesity ( @ % ) .


There were significant differences in the prevalence of CVD risk factors among geographical regions .


The prevalence of at least one risk factor across regions was as follows : North America , @ % ; Europe/Australia/Israel , @ % ; South America , @ % ; Asia , @ % ; Africa , @ % ( P-value < @ ) .


Significant regional differences were also observed when risk factors were used as part of the Framingham and Data Collection on Adverse events of Anti-HIV Drugs ( D : A :D ) risk scores or used to define a favourable risk profile .


CVD risk factors are common among START participants , and their distribution varies by geographical region .


Better understanding of how and why CVD risk factors develop in people with HIV infection and their geographical distributions could shed light on appropriate strategies for CVD prevention and may inform the interpretation of the results of START , as CVD is expected to be a major fraction of the primary endpoints observed .


This randomized controlled trial aimed to evaluate whether the serum procalcitonin ( PCT ) level can be utilized to guide the use of antibiotics in the treatment of acute exacerbations of asthma .


A total of @ consecutive patients with suspected asthma attacks from February @ to July @ participated in this study .


@ patients completed the study .


Serum PCT levels , and other inflammatory biomarkers of all patients were measured .


In addition to the standard treatment , the control group received antibiotics according to the attending physicians ' discretions , while the patients in the PCT group were treated with antibiotics according to serum PCT concentrations .


Antibiotics usage was strongly discouraged when the PCT concentration was below @ g/L ; discouraged when the PCT concentration was between @ g/L and @ g/L ; or encouraged when the PCT concentration was above @ g/L .


The primary endpoint was the determination of antibiotics usage .


The second endpoints included the diagnostic accuracy of PCT and other laboratory biomarkers the effectiveness of asthma control , secondary ED visits , hospital re-admissions , repeated needs for steroids or dosage increase , needs for antibiotics , WBC count , PCT levels and FEV@ % .


At baseline , two groups were identical regarding clinical , laboratory and symptom score .


Probability of the antibiotics usage in the PCT group ( @ % ) was lower than that in the control group ( @ % ) ( @ = @ , p < @ .


RR = @ , @ % CI @-@ @ ) .


PCT and IL-@ showed good diagnostic significance for bacterial asthma ( r = @ , p = @ ) .


The degrees of asthma control in patients were categorized to three levels and were comparable between the two groups at the six weeks follow-up period ( @ = @ , p = @ ) .


There were no significant difference regarding other secondary outcomes ( p > @ ) .


The serum PCT concentration can be used to effectively determine whether the acute asthma patients have bacterial infections in the respiratory tract , and to guide the use of antibiotics in the treatment of acute asthma exacerbations , which may substantially reduce unnecessary antibiotic use without compromising the therapeutic outcomes .


The SYMPLICITY HTN-@ randomized , blinded , sham-controlled trial confirmed the safety of renal denervation ( RDN ) , but did not meet its primary efficacy endpoint .


Prior RDN studies have demonstrated significant and durable reductions in blood pressure .


This analysis investigated factors that may help explain these disparate results .


Patients with resistant hypertension were randomized @ : @ to RDN ( n = @ ) or sham ( n = @ ) .


The primary endpoint was the difference in office systolic blood pressure ( SBP ) change at @ months .


A multivariable analysis identified predictors of SBP change .


Additional analyses examined the influence of medication changes , results in selected subgroups and procedural factors .


Between randomization and the @-month endpoint , @ % of patients underwent medication changes .


Predictors of office SBP reduction at @ months were baseline office SBP @ mmHg , aldosterone antagonist use , and non-use of vasodilators ; number of ablations was a predictor in the RDN group .


Non-African-American patients receiving RDN had a significantly greater change in office SBP than those receiving sham ; -@ @ vs. -@ @ mmHg , respectively ( P = @ ) .


Greater reductions in office and ambulatory SBP , and heart rate were observed with a higher number of ablations and energy delivery in a four-quadrant pattern .


Post hoc analyses , although derived from limited patient cohorts , reveal several potential confounding factors that may partially explain the unexpected blood pressure responses in both the sham control and RDN groups .


These hypothesis-generating data further inform the design of subsequent research to evaluate the potential role of RDN in the treatment of resistant hypertension .


CLINICALTRIALS.GOV IDENTIFIER : NCT@ .


To test the hypothesis that patients with soft tissue changes related to superficial venous insufficiency ( SVI ) have greater benefits from treatment than those with only symptomatic varicose veins .


A commonly held view is that SVI is only a minor ailment , yet randomized clinical trials ( RCTs ) show that treatment improves quality of life ( QoL ) and is cost-effective .


In an effort to curb the treatment costs of this common disorder , rationing is applied in many health care systems , often limiting the reimbursement of treatment to those with soft tissue changes .


This cohort study draws its data from an interventional RCT .


After informed consent , consecutive patients with symptomatic unilateral SVI were randomized to receive surgical ligation and stripping or endovenous laser ablation .