The aim of the research was to test the hypothesis that newly proposed biomarkers of hepatotoxicity would not significantly rise in serum during elevations in serum ALT associated with cholestyramine treatment , which has never been associated with clinically relevant liver injury .


In a double-blind placebo-controlled trial , cholestyramine ( @g ) was administered for @ days to healthy adult volunteers .


Serum from subjects with elevations in alanine aminotransferase ( ALT ) exceeding three-fold the upper limit of normal ( ULN ) were utilized for biomarker quantification .


In @ of @ subjects , cholestyramine treatment resulted in ALT elevation by > @x ULN ( mean @ fold ; range @-@ fold ) .


In these @ subjects , there was a @-fold mean increase in serum levels of miR-@ relative to baseline , supporting a liver origin of the serum ALT .


Significant elevations were noted in mean levels of necrosis biomarkers sorbitol dehydrogenase ( @ fold ) , cytokeratin @ ( @ fold ) and HMGB@ ( @ fold ) .


Caspase-cleaved cytokeratin @ , a biomarker of apoptosis was also significantly elevated ( @ fold ) .


A rise in glutamate dehydrogenase ( @ fold ) may support mitochondrial dysfunction .


All toxicity biomarkers measured in this study were elevated along with ALT , confirming the liver origin and reflecting both hepatocyte necrosis and apoptosis .


Since cholestyramine treatment has no clinical liver safety concerns , we conclude that interpretation of the biomarkers studied may not be straightforward in the context of assessing liver safety of new drugs .


Type @ diabetes can often be prevented by lifestyle modification ; however , successful lifestyle intervention programmes are labour intensive .


Mobile phone messaging is an inexpensive alternative way to deliver educational and motivational advice about lifestyle modification .


We aimed to assess whether mobile phone messaging that encouraged lifestyle change could reduce incident type @ diabetes in Indian Asian men with impaired glucose tolerance .


We did a prospective , parallel-group , randomised controlled trial between Aug @ , @ , and Nov @ , @ , at ten sites in southeast India .


Working Indian men ( aged @-@ years ) with impaired glucose tolerance were randomly assigned ( @:@ ) with a computer-generated randomisation sequence to a mobile phone messaging intervention or standard care ( control group ) .


Participants in the intervention group received frequent mobile phone messages compared with controls who received standard lifestyle modification advice at baseline only .


Field staff and participants were , by necessity , not masked to study group assignment , but allocation was concealed from laboratory personnel as well as principal and co-investigators .


The primary outcome was incidence of type @ diabetes , analysed by intention to treat .


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


We assessed @ participants for eligibility .


@ patients were randomly assigned to either the mobile phone messaging intervention ( n = @ ) or standard care ( n = @ ) .


The cumulative incidence of type @ diabetes was lower in those who received mobile phone messages than in controls : @ ( @ % ) participants in the intervention group developed type @ diabetes compared with @ ( @ % ) in the control group ( hazard ratio @ , @ % CI @-@ ; p = @ ) .


The number needed to treat to prevent one case of type @ diabetes was @ ( @ % CI @-@ ) .


One patient in the control group died suddenly at the end of the first year .


We recorded no other serious adverse events .


Mobile phone messaging is an effective and acceptable method to deliver advice and support towards lifestyle modification to prevent type @ diabetes in men at high risk .


We studied the unclear question whether blood pressure ( BP ) lowering reduces cardiovascular disease ( CVD ) in elderly individuals with systolic BP < @ mm Hg .


We initiated a randomized placebo-controlled stratified @ @ factorial clinical trial evaluating the effects of BP lowering in @ @ elderly individuals with systolic blood pressure ( SBP ) between @ and @ mm Hg , for @ years .


Following @-week active run-in , participants were randomized to aliskiren ( @ mg ) or placebo , and to an additional antihypertensive -LSB- hydrochlorothiazide ( @ mg ) or amlodipine ( @ mg ) -RSB- , or their respective placeboes .


Study was terminated by sponsor after @ subjects ( age @ @ years , @ % receiving at least one antihypertensive ) were randomized and followed for @ year .


Study drugs were well tolerated with few serious adverse events during run-in and after randomization , with no significant differences between treatment groups .


By design , three levels of BP reductions were achieved , adjusted mean BP reductions of @ / @ mm Hg ( P < @ ) by aliskiren , @ / @ mm Hg ( P < @ ) by hydrochlorothiazide or amlodipine , and @ / @ mm Hg ( P < @ ) by double therapy compared with placebo .


Twenty-five major CVD events occurred .


Non-significant trends towards fewer CVD events with greater BP reductions are evident : hazard ratios ( HR ) @ -LSB- @ % confidence interval ( CI ) : @-@ @ -RSB- for @ mm Hg SBP reduction ; HR @ ( @ % CI : @-@ @ ) for @ mm Hg ; and HR @ ( @-@ @ ) for @ mm Hg reduction for primary composite of CV death , MI , stroke , or significant heart failure .


Sizeable reductions in BP , with potential for substantial CVD reduction , can be safely achieved using combinations of BP drugs in the elderly with normal high and Stage @ hypertension .


As a result of research suggesting increased health risk with low serum @-hydroxycholecalciferol ( @ ( OH ) D ) , health care providers are measuring it frequently .


Providers and patients are faced with treatment choices when low status is identified .


To compare the safety and efficacy of three vitamin D@ dietary supplements with different delivery matrices .


A @-week , parallel group , single-masked , clinical trial was conducted in Seattle , Washington and Kailua Kona , Hawaii .


Sixty-six healthy adults with ( @ ( OH ) D ) < @ ng/mL were randomly assigned to take one of three D@ supplements , ie , a chewable tablet ( TAB ) , an oil-emulsified drop ( DROP ) , or an encapsulated powder ( CAP ) at a label-claimed dose of @,@ IU/day .


Actual D@ content was assessed by a third party and the results adjusted based on the actual D@ content administered .


Mean change in @ ( OH ) D/mcg D@ administered ; difference in the proportion of D@ insufficient participants ( ie , @ ( OH ) D @ ng/mL ) reaching sufficiency ( ie , @ ( OH ) D @ ng/mL ) ; and mean change in serum @ , @-dihydroxycholecalciferol were measured .


In two of the three products tested , the measured vitamin D@ content varied considerably from the label-claimed dose .


Differences in @ ( OH ) D/mcg D@ administered were significantly different between groups ( P = @ ; n = @ ) .


Pairwise comparisons demonstrated DROP resulted in a greater increase than TAB ( P < @ ) but not than CAP .


TAB was not different from CAP .


The proportions reaching sufficiency were : @ % ( TAB and CAP ) and @ % ( DROP ) ( P = @ between groups ; n = @ ) .


@ , @-Dihydroxycholecalciferol did not change significantly in any group .


Oil-emulsified vitamin D@ supplements resulted in a greater mean change in serum @ ( OH ) D concentration , but fewer patients reaching vitamin D sufficiency , than chewable or encapsulated supplements .


In the REPAIR-AMI trial , intracoronary infusion of bone marrow-derived cells ( BMCs ) was associated with a significantly greater recovery of contractile function in patients with acute myocardial infarction ( AMI ) at @-month follow-up than placebo infusion .


The current analysis investigates clinical outcome and predictors of event-free survival at @ years .


In the multicentre , placebo-controlled , double-blind REPAIR-AMI trial , @ patients received intracoronary infusion of BMCs ( n = @ ) or placebo ( n = @ ) into the infarct vessel @-@ days following successful percutaneous coronary intervention .


Fifteen patients died in the placebo group compared with seven patients in the BMC group ( P = @ ) .


Nine placebo-treated patients and five BMC-treated patients required rehospitalization for chronic heart failure ( P = @ ) .


The combined endpoint cardiac/cardiovascular/unknown death or rehospitalisation for heart failure was more frequent in the placebo compared with the BMC group ( @ vs. @ events ; P = @ ) .


Univariate predictors of adverse outcomes were age , the CADILLAC risk score , aldosterone antagonist and diuretic treatment , changes in left ventricular ejection fraction , left ventricular end-systolic volume , and N-terminal pro-Brain Natriuretic Peptide ( all P < @ ) at @ months in the entire cohort and in the placebo group .


In contrast , in the BMC group , only the basal ( P = @ ) and the stromal cell-derived factor-@-induced ( P = @ ) migratory capacity of the administered BMC were associated with improved clinical outcome .


In patients of the REPAIR-AMI trial , established clinical parameters are associated with adverse outcome at @ years exclusively in the placebo group , whereas the migratory capacity of the administered BMC determines event-free survival in the BMC-treated patients .


These data disclose a potency-effect relationship between cell therapy and long-term outcome in patients with AMI .


Xpert MTB/RIF is approved for use in tuberculosis ( TB ) and rifampicin-resistance diagnosis .


However , data are limited on the impact of Xpert under routine conditions in settings with high TB burden .


A pragmatic prospective cluster-randomised trial of Xpert for all individuals with presumptive ( symptomatic ) TB compared to the routine diagnostic algorithm of sputum microscopy and limited use of culture was conducted in a large TB/HIV primary care clinic .


The primary outcome was the proportion of bacteriologically confirmed TB cases not initiating TB treatment by @ mo after presentation .


Secondary outcomes included time to TB treatment and mortality .


Unblinded randomisation occurred on a weekly basis .


Xpert and smear microscopy were performed on site .


Analysis was both by intention to treat ( ITT ) and per protocol .


Between @ September @ and @ October @ , @,@ participants were assigned to the Xpert ( n = @ ) and routine ( n = @,@ ) diagnostic algorithms ( ITT analysis ) ; @ received Xpert and @,@ routine ( per protocol analysis ) .


@ % ( @/@ ) of individuals with bacteriologically confirmed TB ( smear , culture , or Xpert ) did not initiate treatment by @ mo after presentation in the Xpert arm , compared to @ % ( @/@ ) in the routine arm ( ITT analysis , risk ratio @ , @ % CI @-@ @ , p = @ ) .


The yield of bacteriologically confirmed TB cases among patients with presumptive TB was @ % ( @/@ ,@ ) with routine diagnosis and @ % ( @/@ ) with Xpert diagnosis ( ITT analysis , risk ratio @ , @ % CI @-@ @ , p < @ ) .


This difference in diagnosis rates resulted in a higher rate of treatment initiation in the Xpert arm : @ % ( @/@ ,@ ) and @ % ( @/@ ) in the routine and Xpert arms , respectively ( ITT analysis , risk ratio @ , @ % CI @-@ @ , p = @ ) .


Time to treatment initiation was improved overall ( ITT analysis , hazard ratio @ , @ % CI @-@ @ , p = @ ) and among HIV-infected participants ( ITT analysis , hazard ratio @ , @ % CI @-@ @ , p = @ ) .


There was no difference in @-mo mortality with Xpert versus routine diagnosis .


Study limitations included incorrect intervention allocation for a high proportion of participants and that the study was conducted in a single clinic .


These data suggest that in this routine primary care setting , use of Xpert to diagnose TB increased the number of individuals with bacteriologically confirmed TB who were treated by @ mo and reduced time to treatment initiation , particularly among HIV-infected participants .


Circumsporozoite protein ( CS ) is the antigenic target for RTS , S , the most advanced malaria vaccine to date .


Heterologous prime-boost with the viral vectors simian adenovirus @ ( ChAd@ ) - modified vaccinia virus Ankara ( MVA ) is the most potent inducer of T-cells in humans , demonstrating significant efficacy when expressing the preerythrocytic antigen insert multiple epitope-thrombospondin-related adhesion protein ( ME-TRAP ) .


We hypothesized that ChAd@-MVA containing CS may result in a significant clinical protective efficacy .


We conducted an open-label , @-site , partially randomized Plasmodium falciparum sporozoite controlled human malaria infection ( CHMI ) study to compare the clinical efficacy of ChAd@-MVA CS with ChAd@-MVA ME-TRAP .


One of @ vaccinees ( @ % ) receiving ChAd@-MVA CS and @ of @ ( @ % ) receiving ChAd@-MVA ME-TRAP achieved sterile protection after CHMI .


Three of @ vaccinees ( @ % ) receiving ChAd@-MVA CS and @ of @ ( @ % ) receiving ChAd@-MVA ME-TRAP demonstrated a delay in time to treatment , compared with unvaccinated controls .


In quantitative polymerase chain reaction analyses , ChAd@-MVA CS was estimated to reduce the liver parasite burden by @ % -@ % , compared with @ % -@ % for ChAd@-MVA ME-TRAP .


ChAd@-MVA CS does reduce the liver parasite burden , but ChAd@-MVA ME-TRAP remains the most promising antigenic insert for a vectored liver-stage vaccine .


Detailed analyses of parasite kinetics may allow detection of smaller but biologically important differences in vaccine efficacy that can influence future vaccine development .


The purpose of the study was to compare behavioral outcomes ( physical activity , sedentary behavior , smoking cessation , diet ) between the intervention and usual care conditions from the TEAMcare trial .


TEAMcare was a randomized trial among @ adults with depression and poorly controlled diabetes and/or coronary heart disease that promoted health behavior change and pharmacotherapy to improve health .


Behavioral outcomes were measured with the International Physical Activity Questionnaire ( physical activity , sitting time ) and the Summary of Diabetes Self-Care Activities Measure ( smoking , diet , exercise ) .


Poisson regression models among completers ( N = @ ) were conducted adjusting for age , education , smoking status and depression .


Intervention participants had more days/week following a healthy eating plan -LSB- relative rate = @ , @ % confidence interval ( CI ) = @-@ @ -RSB- and more days of participation in @ min of physical activity ( relative rate = @ , @ % CI = @-@ @ ) compared to usual care .


Intervention participants were more likely to meet physical activity guidelines ( @ % increase ) compared to usual care ( @ % decrease ; P = @ ) .


Diet and activity generally improved for those receiving the intervention , while there were no differences in some aspects of diet ( fruit and vegetable and high-fat food intake ) , smoking status and sitting time between conditions in the TEAMcare trial .


The @ American Heart Association guidelines suggested an increase in cardiopulmonary resuscitation compression depth with a target > @ mm and no upper limit .


This target is based on limited evidence , and we sought to determine the optimal compression depth range .


We studied emergency medical services-treated out-of-hospital cardiac arrest patients from the Resuscitation Outcomes Consortium Prehospital Resuscitation Impedance Valve and Early Versus Delayed Analysis clinical trial and the Epistry-Cardiac Arrest database .


We calculated adjusted odds ratios for survival to hospital discharge , @-day survival , and any return of circulation .


We included @ adult patients from @ US and Canadian cities with a mean age of @ years , mean compression depth of @ mm , and a return of circulation of @ % , @-day survival of @ % , and survival to hospital discharge of @ % .


For survival to discharge , the adjusted odds ratios were @ ( @ % CI , @-@ @ ) for each @-mm increment in compression depth , @ ( @ % CI , @-@ @ ) for cases within @ depth range ( > @ mm ) , and @ ( @ % CI , @-@ @ ) for percentage of minutes in depth range ( @ % change ) .


Covariate-adjusted spline curves revealed that the maximum survival is at a depth of @ mm ( @-mm interval with highest survival between @ and @ mm ) with no differences between men and women .


This large study of out-of-hospital cardiac arrest patients demonstrated that increased cardiopulmonary resuscitation compression depth is strongly associated with better survival .


Our adjusted analyses , however , found that maximum survival was in the depth interval of @ to @ mm ( peak , @ mm ) , suggesting that the @ American Heart Association cardiopulmonary resuscitation guideline target may be too high .


To compare the efficacy differences between acupuncture combined with auricular point sticking therapy and clomiphene oral administration in the treatment of polycystic ovary syndrome ( PCOS ) .


One hundred cases of PCOS were randomized into two groups , @ cases in each one .


Acupuncture com bined with auricular point sticking group ( group A ) : acupuncture was applied at Guanyuan ( CV @ ) , Zhongji ( CV @ ) and Zigong ( EX-CA @ ) , once daily ; auricular point sticking was applied at Spleen ( pi , CO@ ) , Endocrine ( neifenmi , CO@ ) , Unterus and Kidney ( shen , CO@ ) , t he plaster was changed once a week .


Clomiphene grou p ( group B ) : oral clomiphene was prescribed at the @th day of the menstrual , for @ consecutive days , totally @ menstrual cycles was needed .


The ovulation induction , pregnancy and menstruation resuming of patients in the two ' , The totally effective rate was @ % ( @/@ ) in group A , which was group were observed and compared .


The totally effective rate was @ % ( @/@ ) in group A , which was superior to @ % ( @/@ ) in group B ( P < @ ) ; the ovulation rate and pregnancy rate were @ % ( @/@ ) and @ % ( @/@ ) in group A , whiche were superior to that of group B ( all P < @ ) ; the menstruation resuming rate was @ ( @/@ ) in group A , which was superior to @ ( @/@ ) in group B ( P < @ ) .


No adverse effect was observed in group A , while in group B , varying degrees of nausea , vomiting , headache and dermatitis were observed in @ cases , ovarian hyperstimulation syndrome ( OHSS ) like polycystic ovary was observed in @ cases under the B ultrasound .


Acupuncture combined with auricular point sticking therapy has a better effect than clomiphene in the treatment of PCOS without any adverse effect .


Former sleep studies among non-treatment seeking chronic cocaine users had captured polysomnographic changes for as long as three weeks of abstinence .


@ cocaine dependent participants , randomized to placebo in an ongoing clinical trial , received @ days of inpatient substance abuse treatment followed by @ weeks of outpatient cognitive behavioral therapy .


Polysomnographic recording was performed on consecutive nights during the @st and @nd inpatient and @rd and @th outpatient weeks .


Number of days abstinent was determined from thrice weekly urine toxicology and self-report .


Polysomnographic sleep was compared between study week @ and @ , using paired t-tests .


Trajectory of total sleep time ( TST ) was modeled both as a linear and a quadratic function of days abstinent .


Despite reporting an improvement in overall sleep quality , polysomnographic sleep worsened from week @ to @ .


Among all participants , TST and stage @ sleep time decreased , while REM sleep latency increased .


Among participants who began the study with a positive urine test , there was also a decrease in REM and a trend for decreased slow wave sleep .


TST compared to number of days abstinent ( up to @ days ) was best fit with a quadratic model ( p = @ ) , suggesting the possibility of an improvement in total sleep time with extended abstinence .


This is the first polysomnographic characterization of sleep in a large sample of cocaine users in treatment .


Present findings confirm earlier results of poor and deteriorating sleep early in abstinence , and raise the possibility of improvement after an extended abstinence .


Assessment of differences in soft tissue healing and long-term issues between two techniques for bone-anchored hearing implant ( BAHI ) surgery .


Single-center , randomized , nonblinded study using balanced randomization ( @:@ ) .


Tertiary referral center in the Central Denmark Region .


Forty-seven adults with normal skin quality .


Operation with a BAHI system with randomization to @ ) dermatome technique with soft tissue removal and @ ) linear incision with no soft tissue reduction .


Holgers ' score , pain , and sensibility loss assessed at @ , @ , @ , @ , @ , and @ days and @ , @ , @ , and @ months postoperatively .


Implant loss .


Forty-nine patients were randomized ( linear incision , n = @ ; dermatome , n = @ ) .


Forty-seven patients were analyzed ( linear incision , n = @ ; dermatome , n = @ ) .


Differences in proportions for grouped data ( outcome @ and outcome > @ ) for the total of all visits were Holgers ' Index : @ ( p = @ ; @ % confidence interval -LSB- @ % CI -RSB- , @-@ @ ) ; sensibility loss : @ ( p = @ @ ; @ % CI , @-@ @ ) ; pain : @ ( p = @ ; @ % CI , @-@ @ ) .


Soft tissue reactions and pain were most prominent in the early postoperative period , whereas issues with sensibility loss subsided throughout the @-year follow-up period .


No implants were lost .


In a randomized trial for BAHI surgery , the linear incision with no subcutaneous reduction had a faster healing time and inflicted less pain and sensibility loss than the dermatome technique .


The long-term soft tissue problems were similar in the two groups , thus favoring the linear incision , which is less invasive .


The combined IVGTT-hyperinsulinaemic-euglycaemic clamp ( Botnia clamp ) allows the assessment of insulin secretion and sensitivity in one experiment .


It remains unclear whether this clamp yields results comparable with those of the standard hyperinsulinaemic-euglycaemic clamp ( SHEC ) in diabetes patients .


We hypothesised that the IVGTT induces responses affecting insulin sensitivity assessment .


Of @ randomised diet - or metformin-treated patients with well-controlled type @ diabetes , @ randomly underwent a Botnia clamp and an SHEC , spaced by @ weeks , in one clinical research centre in a crossover study .


The main outcomes were whole-body and hepatic insulin sensitivity as measured by the clamp and -LSB- @,@ - ( @ ) H@ -RSB- glucose .


Substrate utilisation was assessed from indirect calorimetry and beta cell function from insulin dynamics during IVGTT .


The values of whole-body insulin sensitivity obtained from Botnia clamp and SHEC were correlated ( r = @ , p < @ ) , but also revealed intra-individual variations .


Hepatic insulin sensitivity did not differ between experiments during the clamp , but differed after IVGTT .


The contribution of glucose oxidation to glucose disposal increased by @ @ and @ @ mg kg fat-free mass ( FFM ) ( -@ ) min ( -@ ) ( Botnia and SHEC , p < @ ) , whereas lipid oxidation decreased by @ @ and @ @ mg kg FFM ( -@ ) min ( -@ ) ( p < @ ) from baseline .


Differences in NEFA ( r = -@ , p < @ ) , but not C-peptide ( r = -@ , p = @ ) or hepatic insulin sensitivity between IVGTT and placebo before the clamps correlated with individual variations of insulin sensitivity .


The Botnia clamp provides similar estimates of insulin sensitivity as SHEC in patients with type @ diabetes , but changes in NEFA during IVGTT may affect insulin sensitivity and thereby the discrimination between insulin-sensitive and insulin-resistant individuals .


Clinical studies of recent years have shown that hyperuricemia is associated with poor outcomes such as cardiovascular mortality and dialysis inadequacy in patients undergoing hemodialysis .


Our study investigated the effect of vitamin C supplementation on serum uric acid levels in hemodialysis patients .


This randomized placebo-controlled trial was conducted on @ hemodialysis patients .


They were randomly divided into the intervention group , to receive @ mg of vitamin C , three times per week , for @ weeks , and control groups @ and @ , to receive placebo injection ( saline ) and no intervention , respectively .


Serum levels of uric acid and creatinine were measured at the start of the study and also after @ weeks .


The mean of serum levels of uric acid was @ @ mg/dL ( reference range , @ mg/dL to @ mg/dL ) .


Nearly , half of the patients ( @ % ) had a serum level of uric acid greater than @ mg/dL .


The median baseline serum levels of uric acid were @ mg/dL , @ mg/dL , and @ mg/dL in the intervention , control @ , and control @ groups , respectively ( P = @ ) .


After @ months , median levels reduced significantly in the vitamin C group to @ mg/dL as compared to @ mg/dL and @ mg/dL in control groups ( P = @ ) .


The mean serum creatinine level had no significant changes during the study .


Our results demonstrated the existence of a significant negative relationship between vitamin C and serum uric acid levels .


Detailed investigations with larger sample sizes and longer-term use of vitamin C are recommended .


This prospective long-term follow-up study evaluated the effects of half-dose etanercept ( @ mg weekly ) on clinical remission and radiographic progression in a large cohort of patients with rheumatoid arthritis ( RA ) in clinical remission after etanercept @ mg bi-weekly .


@ biologic-nave RA patients were treated with etanercept @ mg bi-weekly after failure of conventional drugs .


Patients achieving remission ( DAS@ < @ ) for @ months were randomised to receive etanercept @ mg weekly or @ mg bi-weekly .


Patients were assessed at baseline and every @ weeks .


Remission rates , radiographic progression , incidence of infections and costs of the regimens were compared .


After a mean follow-up of @ months , @ patients ( @ % ) achieved DAS@ remission ; @ were randomised to one of two dose regimens : etanercept @ weekly ( group A , @ patients ) and etanercept @ mg bi-weekly ( group B , @ patients ) .


At the end of follow-up , @ % patients of group A maintained remission for a mean of @ years .


Radiographic progression occurred in a small number of patients of group A and the rate of radiographic progression ( TSS > @ ) was not significantly different in the two groups ( @ % vs. @ % after the first year and @ % vs. @ % after the second year , respectively ) .


The incidence ratio of severe infections was @ / @ patient-years in group A. Etanercept half-dose regimen resulted in a saving of @ with a cost saving up to @ per year .


Clinical remission and arrest of radiographic progression persisted in a substantial percentage of patients with RA even after reduction of standard-dose etanercept .


Acute appendicitis is the most common reason for abdominal surgery in young adults and children .


Open appendectomy is still the treatment often chosen because it is simple , safe , and effective .


Our aim was to study whether cosmetic results of appendectomy wounds are better after using continuous absorbable intradermal ( A ) sutures compared with wound closure with interrupted nonabsorbable ( NA ) sutures .


A total of @ adult patients with clinically suspected appendicitis were allocated to the study and prospectively randomized into two wound-closure groups : the interrupted NA suture group and the A suture group .


Of these , @ patients with sufficient data were invited to the outpatient clinic for cosmetic analysis .


Cosmetic results were evaluated after a median of @ months .


For subjective scar assessment , the Vancouver scar scale , the patient and observer scar assessment scale ( POSAS ) , and a visual analog scale ( VAS ) were used .


Objective evaluation was carried out by measuring surface area , average width , and estimated concentration change ( ECC ) of hemoglobin and melanin in the scar using spectrocutometry .


For statistical analyses we used the Mann-Whitney test and Student 's t test .


Both objective and subjective analyses showed better cosmetic results for absorbable intradermal suturing .


The difference between the two groups was statistically significant as regards POSAS in both patient ( p = @ ) and observer scales ( p = @ ) , and VAS ( p = @ ) .


Scar surface area was significantly smaller in group A than in group NA ( p = @ ) .


ECC measurements showed higher values for melanin in group NA than in group A ( p = @ ) .


Continuous intradermal absorbable suturing yields a better cosmetic result than interrupted nonabsorbable suturing in lower abdominal transverse appendectomy .


We investigated @ approaches for implementing the Chronic Care Model to improve diabetes care : ( @ ) practice facilitation over @ months using a reflective adaptive process ( RAP ) approach ; ( @ ) practice facilitation for up to @ months using a continuous quality improvement ( CQI ) approach ; and ( @ ) providing self-directed ( SD ) practices with model information and resources , without facilitation .


We conducted a cluster-randomized trial , called Enhancing Practice , Improving Care ( EPIC ) , that compared these approaches among @ small to midsized primary care practices .


At baseline and @ months and @ months after enrollment , we assessed practice diabetes quality measures from chart audits and Practice Culture Assessment scores from clinician and staff surveys .


Although measures of the quality of diabetes care improved in all @ groups ( all P < @ ) , improvement was greater in CQI practices compared with both SD practices ( P < @ ) and RAP practices ( P < @ ) ; additionally , improvement was greater in SD practices compared with RAP practices ( P < @ ) .


In RAP practices , Change Culture scores showed a trend toward improvement at @ months ( P = @ ) but decreased below baseline at @ months ( P < @ ) , while Work Culture scores decreased from @ to @ months ( P < @ ) .


Both scores were stable over time in SD and CQI practices .


Traditional CQI interventions are effective at improving measures of the quality of diabetes care , but may not improve practice change and work culture .


Short-term practice facilitation based on RAP principles produced less improvement in quality measures than CQI or SD interventions and also did not produce sustained improvements in practice culture .


Intracoronary thrombus is disrupted by stent deployment and confounded by the development of intrastent plaque prolapse .


This study aims at investigating the feasibility and repeatability of thrombus quantification prior to stent implantation using optical coherence tomography ( OCT ) in ST-segment elevation myocardial infarction ( STEMI ) patients .


Patients were enrolled in an OCT substudy of the TOTAL trial ( a randomized trial of routine aspiration ThrOmbecTomy with PCI vs. PCI ALone in patients with STEMI undergoing primary PCI ) of aspiration thrombectomy or percutaneous coronary intervention ( PCI ) alone in primary PCI ( PPCI ) of STEMI .


Using OCT , thrombus burden ( TB ) and other measures of pre - and post-stent atherothrombus were analysed over the arterial segment defined by the final stent length .


Feasibility was @ % ( @/@ patients ) for both pre - and post-stent OCT imaging .


Altogether , @ OCT cross-sections were analysed .


In Bland-Altman analyses of inter-observer variation ( n = @ ) , the mean pre-stent TB was @ % for Observer @ and @ % for Observer @ ( limits of agreement -@ to @ % ) .


In Bland-Altman analyses of intra-observer variation ( n = @ ) , the mean pre-stent TB was @ % for the first and @ % for the second round of analysis by Observer @ ( limits of agreement -@ to @ % ) .


There was a good correlation between pre-stent TB and pre-stent quadrants with thrombus/mm ( r = @ ) , but only modest correlation between pre-stent TB and post-stent atherothrombotic burden ( ATB ; r = @ ) .


Measurement of pre-stent TB by OCT during the PPCI of STEMI is feasible and highly repeatable .


Pre-stent TB is only modestly correlated with post-stent ATB , which indicates that pre-stent measurements might be of additional value when assessing the TB in STEMI .


The aim of this study was to investigate the degree of correlation between the Pelvic Organ Quantification system ( POP-Q ) measurements and symptom questionnaire scores before and after surgery .


This was a part of a randomized controlled study comparing conventional colporrhaphy with mesh repair surgery .


The correlation between POP-Q measurements and Pelvic Floor Impact Questionnaire ( PFIQ-@ ) and Pelvic Floor Distress Inventory ( PFDI-@ ) scores was investigated in @ women @ years or older scheduled for primary anterior vaginal wall prolapse surgery at baseline and the correlation between the change in point Ba and scores following surgery .


Statistical analyses used McNemar 's and Wilcoxon signed-rank tests , Spearman 's rank-order correlation , and multiple linear regression .


Surgery significantly improved POP-Q , PFIQ-@ , and PFDI-@ scores , including subscales .


We observed weak correlations between POP-Q and PFIQ-@ , including subscales ( r @-@ @ , p < @ ) , and PFDI-@ , including the Pelvic Organ Prolapse Distress Inventory ( POPDI ) subscale ( r @-@ @ , p < @ ) .


Regression analysis demonstrated a significant relationship between point Ba and PFIQ-@ ( p = @ ) and PFDI-@ ( p = @ ) , respectively .


Furthermore , we observed a significant relationship between the change in point Ba ( following surgery ) and change in scores ; point Ba following surgery was significantly correlated with symptoms of bulging ( r = @ , p < @ ) and bladder-emptying problems ( r = @ , p < @ ) .


The weak correlation between POP-Q and urogenital symptoms based on questionnaire scores suggests that neither scoring system is optimal .


Pressure ulcers are one of the most common health complaints , which often take months or years to heal , and affect patients ' morbidity and quality of life .


Medical options for pressure ulcers are limited .


Electroacupuncture ( EA ) has been employed to relieve the symptoms for patients with pressure ulcers , but there is limited clinical evidence for its effectiveness .


This study consists of a randomized controlled trial ( RCT ) with two parallel arms : a control group and an EA group .


Both groups will receive standard wound care ( including changing position , using mattresses and cushions , and a good diet ) of five sessions per week for a total of @ sessions during the @-week treatment period .


In addition , the EA group will receive the EA intervention .


The following outcome measurements will be used in examination of participants : wound surface area ( WSA ) , visual analogue scale ( VAS ) , and the proportion of ulcers healed within trial period ( PUHTP ) .


All the outcomes will be evaluated at the start of the study , at the end of the fourth week , at @ weeks after randomization , and @ month after treatment cessation .


The aim of this study is to evaluate the effectiveness of EA for the treatment of patients with pressure ulcers .


Although statins can induce coronary atheroma regression , this benefit has yet to be demonstrated in diabetic individuals .


We tested the hypothesis that high-intensity statin therapy may promote coronary atheroma regression in patients with diabetes .


The Study of Coronary Atheroma by Intravascular Ultrasound : Effect of Rosuvastatin Versus Atorvastatin ( SATURN ) used serial intravascular ultrasound measures of coronary atheroma volume in patients treated with rosuvastatin @ mg or atorvastatin @ mg for @ months .


This analysis compared changes in biochemistry and coronary percent atheroma volume ( PAV ) in patients with ( n = @ ) and without ( n = @ ) diabetes .


At baseline , patients with diabetes had lower LDL cholesterol ( LDL-C ) and HDL cholesterol ( HDL-C ) levels but higher triglyceride and CRP levels compared with patients without diabetes .


At follow-up , diabetic patients had lower levels of LDL-C ( @ @ vs. @ @ mg/dL , P = @ ) and HDL-C ( @ @ vs. @ @ mg/dL , P < @ ) but higher levels of triglycerides ( @ -LSB- @ , @ -RSB- vs. @ mg/dL -LSB- @ , @ -RSB- , P = @ ) and CRP ( @ -LSB- @ , @ -RSB- vs. @ -LSB- @ , @ -RSB- mg/L , P = @ ) .


Both patients with and without diabetes demonstrated regression of coronary atheroma as measured by change in PAV ( -@ @ vs. -@ @ % , P = @ ) .


PAV regression was less in diabetic compared with nondiabetic patients when on-treatment LDL-C levels were > @ mg/dL ( -@ @ vs. -@ @ % , P = @ ) but similar when LDL-C levels were @ mg/dL ( -@ @ vs. -@ @ % , P = @ ) .


High-intensity statin therapy alters the progressive nature of diabetic coronary atherosclerosis , yielding regression of disease in diabetic and nondiabetic patients .


To evaluate the effects of different intracorporeal ligation techniques with titanium clips , Plasma Trisector ( Gyrus , USA ) ( PTG ) , and surgical silk on bilateral laparoscopic varicocelectomy ( LPVx ) .


Between May @ and August @ , @ patients who underwent bilateral LPVx were evaluated .


The demographic parameters of patients , preoperative radiological findings , semen analysis , operative data , and follow-up were recorded .


All of the patients were divided into @ groups , randomized prospectively .


The patients whose veins were ligated by @-mm titanium clips were included in group I , those whose veins were ligated by PTG were included in group II , and those whose veins were ligated by surgical silk were included in group III .


The recorded data of the groups were analyzed .


Mean follow-up time was @ + @ months .


According to the demographics of age , body mass index , spermiogram , and diameter of veins before surgery , there were no statistical differences between any of the groups ( P > @ ) .


However , operation time was longer in group III ( P < @ ) , while total numbers ofligated veins did not differ among the groups ( P > @ ) .


Additionally , hospital stay , oral intake , and complications were not different among the groups ( P > @ ) .


In follow-up the sperm count analysis was higher than the preoperative count analysis for all of the groups ( P < @ ) .


PTG may provide a shorter operation time than using titanium clips and/or surgical silk in LPVx .


Additionally , PTG may increase sperm count with fewer complications than the other ligation techniques in LPVx .


Therefore , PTG may be the new candidate electrosurgical standard device for LPVx in the nearby future .


To compare the level of anxiety and performance of nursing students when performing a clinical simulation through the traditional method of assessment with the presence of an evaluator and through a filmed assessment without the presence of an evaluator .


Controlled trial with the participation of Brazilian public university @ students who were randomly assigned to one of two groups : a ) assessment through the traditional method with the presence of an evaluator ; or b ) filmed assessment .


The level of anxiety was assessed using the Zung test and performance was measured based on the number of correct answers .


Averages of @ and @ were obtained on the anxiety scale by the group assessed through the traditional method before and after the simulation , respectively , while the filmed group obtained averages of @ and @ ; the final scores correspond to mild anxiety .


Even though there was a statistically significant reduction in the intra-groups scores before and after the simulation , there was no difference between the groups .


As for the performance assessments in the clinical simulation , the groups obtained similar percentages of correct answers ( @ % in the traditional assessment and @ % in the filmed assessment ) without statistically significant differences .


Filming can be used and encouraged as a strategy to assess nursing undergraduate students .


We aimed to evaluate whether oral anticoagulants ( OACs ) alter faecal immunochemical test ( FIT ) performance in average-risk colorectal cancer ( CRC ) screening .


Individuals aged @-@ years were invited to receive one FIT sample ( cutoff @ ng ml ( -@ ) ) between November @ and June @ .


Faecal immunochemical test was positive in @ % ( @ out of @ ) of users of OAC and @ % ( @ out of @ ) of non-users ( P-trend = @ ) .


The positive predictive value ( PPV ) for advanced neoplasia ( AN ) in non-users was @ % vs @ % in users ( odds ratio , @ ; @ % CI , @-@ @ ; P = @ ) .


The PPV for AN in OAC more antiplatelets ( aspirin or clopidogrel ) was @ % ( odds ratio , @ ; @ % CI , @-@ @ ; P = @ ) .


Oral anticoagulant did not significantly modify the PPV for AN in this population-based colorectal screening program .


The detection rate of advanced adenoma was higher in the combination OAC more antiplatelets .


Virtual patients ( VPs ) offer valuable alternative encounters when live patients with rare conditions , such as cranial nerve ( CN ) palsies , are unavailable ; however , little is known regarding simulation and optimal social learning context .


Compare learning outcomes and perspectives between students interacting with VPs in individual and team contexts .


Seventy-eight medical students were randomly assigned to interview and examine four VPs with possible CN damage either as individuals or in three-person teams , using Neurological Examination Rehearsal Virtual Environment ( NERVE ) .


Learning was measured through diagnosis accuracy and pre - / post-simulation knowledge scores .


Perspectives of learning context were collected post-simulation .


Students in teams submitted correct diagnoses significantly more often than students as individuals for CN-IV ( p = @ ; team = @ % ; individual = @ % ) and CN-VI ( p = @ ; team = @ % ; individual = @ % ) .


Knowledge scores increased significantly in both contexts ( p < @ ) ; however , a significant aptitude-treatment interaction effect was observed ( p = @ ) .


At pre-test scores @ % , students in teams scored significantly higher ( @ % ) than students as individuals ( @ % ) at post-test ( p = @ ) .


Students recommended implementing future NERVE exercises in teams over five other modality-timing combinations .


Results allow us to define best practices for integrating VP simulators into medical education .


Implementing NERVE experiences in team environments with medical students in the future may be preferable .


Exercise-induced cough ( EIC ) is frequently reported by winter athletes , but this symptom is not always associated with exercise-induced bronchoconstriction ( EIB ) .


The aims of this study were to determine if EIC can be inhibited or reduced with the inhalation of ipratropium , and if EIC in winter athletes is associated with EIB .


On @ visits , @ cross-country skiers ( @ males and @ females , mean age @ @ years ) performed an outdoor exercise in the winter ( @-minute warm-up , followed by a @-minute sprint ) , randomly preceded by the inhalation of ipratropium or a placebo .


A spirometry was done at baseline and @ minutes after inhalation of ipratropium or placebo .


Exercise was then performed , followed by the measurement of forced expiratory volume in @ second and the recording of the number of coughs until @ minutes after exercise .


Before and after exercise , the perception of cough intensity was evaluated using a modified Borg scale .


Twelve of @ athletes who completed the study ( @ % ) were symptomatic following exercise with placebo ( number of coughs @ ) , but none developed EIB .


For these athletes , the number of coughs after exercise ( mean number of coughs standard deviation : placebo , @ @ ; ipratropium , @ @ ; P value , nonsignificant ) and the maximal perception score for cough intensity ( mean Borg score standard deviation : placebo , @ @ ; ipratropium , @ @ ; P value , nonsignificant ) were not significantly different between ipratropium and placebo .


A decrease in the number of coughs was observed in @ of the symptomatic athletes and an increase was observed in the other @ , resulting in a nonsignificant mean effect .


Ipratropium does not appear to significantly influence the number and the perception of cough following exercise .


Moreover , these results suggest that EIC is not mainly associated with EIB .


However , a subgroup of athletes seems to show a beneficial response to ipratropium , suggesting different cough responses in this population .


The Avosentan on Time to Doubling of Serum Creatinine , End Stage Renal Disease or Death ( ASCEND ) trial tested the renoprotective effect of the endothelin receptor antagonist avosentan in patients with diabetes and nephropathy , but the study was terminated due to an excess of congestive heart failure ( CHF ) events in the avosentan arms , likely due to fluid retention .


The aim of this study was to identify risk markers of CHF after treatment with avosentan .


In a post hoc analysis of the ASCEND trial ( N = @ participants ) , we assessed which baseline characteristics predicted CHF risk during avosentan treatment .


Furthermore , postrandomization changes between baseline and the first available measurement of body weight and hemoglobin were examined as potential clinical indicators of fluid retention for their relationship with CHF development .


Relative to placebo , avosentan increased CHF risk ( hazard ratio , @ ; @ % confidence interval , @ to @ ) .


The avosentan-related CHF risk was higher with lower baseline cholesterol levels ( P interaction = @ ) and concomitant statin use ( P interaction = @ ) , whereas it was lower with a lower estimated GFR ( P interaction = @ ) .


Patients allocated to avosentan had a median body weight increase of @ kg ( interquartile range , @ to @ kg ) and a median hemoglobin decrease of @ g/dl ( interquartile range , -@ to -@ g/dl ) at the first postrandomization measurement .


The body weight increase induced by avosentan was associated with CHF development ( P interaction = @ ) , whereas hemoglobin decrease was not ( P interaction = @ ) .


The increase in body weight was particularly pronounced in patients with a cardiovascular disease history and in patients using statins .


In avosentan-treated patients , body weight increase , but not hemoglobin decrease , was associated with CHF development , indicating that close body weight monitoring could provide an early signal of CHF development in future trials with endothelin receptor antagonists .


The aim of this study was to measure round window ( RW ) diameters in patients with congenital aural atresia ( CAA ) or sensorineural hearing loss ( SNHL ) and a normal control group and to analyze whether differences exist between these groups .


Temporal bone computed tomographic scans of @ patients with CAA ( @ males , @ females ) aged @ to @ years ( median age , @ years ) , @ patients with SNHL ( @ males , @ females ) aged @ to @ years ( median age , @ years ) , and @ patients ( @ males , @ females ) aged @ months to @ years ( median age , @ years ) randomly selected from a pool of patients with unilateral chronic otitis media or cholesteatoma were reviewed .


We measured RW diameter on oblique reconstruction planes .


To prevent possible individual differences , skull width was measured .


There were no statistically significant differences between all groups for skull width .


Both RW diameter and RW membrane width were found smaller in the CAA group than both SNHL group and control group with statistical significance , whereas there were no statistically significant differences between the SNHL group and the control group .


We found that both the RW diameter and RW membrane width in CAA were smaller than those in the control group .


If this finding is supported in future studies , the production of floating mass transducer with different sizes may be useful .


We suggest that RW diameter should be measured in each patient before operation and thus a floating mass transducer with the appropriate caliber should be chosen .


New topical treatments studied in adults have been published to be potentially effective in the treatment of hypertrophic scar and keloids .


There is still no study in Thai children .


To study the efficacy of @ % onion extract in silicone derivative gel for the prevention of hypertrophic scar and keloid in median sternotomy wound from open heart surgery in pediatric patients .


Thirty-nine pediatric patients who had median sternotomy were recruited in this prospective randomized , double-blinded , placebo-controlled split-scar experimental study .


The wound in each patient was divided into upper and lower parts , and the treatment with , either onion extract gel or placebo was randomly applied by block randomization onto each part of the wound twice daily after the seventh day postoperatively for six months .


The incidence of scars , serial photographs of the wound , Vancouver Scar Scale ( VSS ) , and adverse effect were assessed at each visit .


Thirty patients with the mean age of @ years completed the @-month study period .


Six patients ( @ % ) in onion extract gel group had no scar compared to one patient ( @ % ) in placebo group ( p = @ ) .


Of the @ patients with hypertrophic scar nine were from onion extract gel group and @ from the placebo group ( p = @ ) .


Keloid was not statistically significant diferent in both groups ( p = @ ) .


VSS was not statistically significant different in all visits .


One case had a pustule on the part of the onion extract in silicone derivative application at the sixth month .


Onion extract in silicone derivative gel can significantly decreased the incidence of hypertrophic scar from median sternotomy wound in pediatric patients .


Keloid did not show statistically significant differences in both groups .


To investigate the characteristics of residual symptoms and to evaluate the effects of adjuvant vestibular suppressants on residual symptoms after successful canalith repositioning procedures ( CRPs ) .


Individual randomized controlled trial .


One hundred fifty patients with idiopathic benign paroxysmal positional vertigo who achieved successful CRPs on initial visit participated in this study .


Dizziness Handicap Inventory ( DHI ) questionnaires were completed before CRPs .


All study populations were divided into three groups after successful CRPs on the initial visit day : the medication ( V ) group ( treated with a vestibular suppressant -LSB- dimenhydrinate @ mg per day -RSB- ) , the placebo ( P ) group , and the no medication ( N ) group .


One week after successful CRPs , residual symptoms were checked and repeated DHI questionnaires were completed to compare residual symptoms .


Among the @ patients who did not show positional nystagmus at follow-up , @ ( @ % ) complained of residual symptoms .


The presence of residual symptoms was more prevalent in the P and N group compared with the V group ( P = @ , P = @ , respectively ) .


The most frequent residual symptom was lightheadedness ( n = @ ) .


Moreover , in the V group , lightheadedness was significantly reduced compared with the P group ( P = @ ) .


However , in the analysis of DHI , total and subscale scores did not differ across the three groups before or after successful CRP .


Vestibular suppressants significantly reduced residual symptoms compared to both placebo and no medication after CRP .


However , there was no significant reduction in DHI score compared with the control group , suggesting that the residual symptoms could not be evaluated by DHI score alone .


To study the effect of perioperative immunomodulatory therapy on postoperative recurrence of rectal cancer .


This prospective study was conducted among @ rectal/anal cancer patients undergoing intersphincteric resection at our center between January , @ and January , @ , among whom @ were eligible to be included and completed the study .


The @ patients were randomized in a double-blinded fashion into @ equal groups to receive immunomodulatory therapy with @ mg/kg celecoxib ( group A ) , @ mg/kg Sou-Medrol ( group B ) , or placebo ( group C ) , given daily from @ days before surgery to @ days after surgery , and the postoperative cancer recurrence were compared .


At @ days after the operation , the @ groups showed significantly different C-reactive protein ( CRP ) levels , which decreased obviously in all the @ groups compared with those at @ day following the operation ( P = @ ) , especially in group B.


The levels of interleukin-@ ( IL-@ ) at @ days after the operation also differed significantly between the @ groups but were lower in all the @ groups than those at @ day after the operation ( P = @ ) , and this reduction was the most obvious in group A. COX-@ expression differed significantly between the @ groups ( P = @ ) , among which group A showed the most obvious suppression of COX-@ expression .


During the follow-up for a mean of @ months , no significant difference in the recurrence rate was found between the @ groups ( P = @ ) .


With a lower efficacy than Sou-Medrol in decreasing postoperative inflammation , celecoxib produces a better effect in inhibiting COX-@ expression , but it does not lower postoperative recurrence rate of rectal cancer .


In trials of behavioural interventions , the individuals who deliver the intervention are in a position of key influence on the success of the trial .


Their fidelity to the intervention is crucial .


Yet little is understood about the experiences of this group of trial personnel .


This study aimed to investigate the views and experiences of educators who delivered a structured education intervention to people with type @ diabetes , which incorporated training in self-monitoring of either blood glucose ( SMBG ) or urine glucose ( SMUG ) as part of a randomized controlled trial ( RCT ) .


Educators ' views were explored through focus groups before and after training ( N = @ ) and approximately @ year into the trial ( N = @ ) , and semi-structured telephone interviews at approximately @ years ( N = @ ) .


Analysis was based on the constant comparative method .


Educators held preferences regarding the intervention variants ; thus , they were not in individual equipoise .


Training raised awareness of preferences and their potential to impact on delivery .


Educators were confident in their unbiased delivery , but acknowledged the challenges involved .


Concealing their preferences was helped by a sense of professionalism , the patient-centred nature of the intervention , and concessions in the trial protocol ( enabling participants to swap monitoring methods if needed ) .


Commitment to unbiased delivery was explained through a desire for evidence-based knowledge in the contentious area of SMBG .


The findings provide insight into a previously unexplored group of trial personnel -- intervention deliverers in trials of behavioural interventions -- which will be useful to those designing and running similar trials .


Rather than individual equipoise , it is intervention deliverers ' awareness of personal preferences and their potential impact on the trial outcome that facilitates unbiased delivery .


Further , awareness of community equipoise , the need for evidence , and relevance to the individual enhance commitment to the RCT .


The purpose of this study is to determine whether varying the format used to present prognostic data alters the perception of risk among surrogate decision makers in the intensive care unit ( ICU ) .


This was a prospective randomized comparative trial conducted in a @-bed adult tertiary ICU .


Enrolled surrogate decision makers were randomized to @ of @ questionnaires , which presented hypothetical ICU scenarios , identical other than the format in which prognostic data were presented ( eg , frequencies vs percentages ) .


Participants were asked to rate the risk associated with each prognostic statement .


We enrolled @ surrogate decision makers .


The perception of risk varied significantly dependent on the presentation format .


For `` quantitative data , '' risks were consistently perceived as higher , when presented as frequencies ( eg , @ in @ ) compared with equivalent percentages ( eg , @ % ) .


Framing `` qualitative data '' in terms of chance of `` death '' rather than `` survival '' led to a statistically significant increase in perceived risks .


Framing `` quantitative '' data in this way did not significantly affect risk perception .


Data format had a significant effect on how surrogate decision makers interpreted risk .


Qualitative statements are interpreted widely and affected by framing .


Where possible , multiple quantitative formats should be used for presenting prognostic information .


The training response of an intensified period of high-intensity exercise is not clear .


Therefore , we compared the cardiovascular adaptations of completing @ high-intensity aerobic interval training sessions carried out for either three or eight weeks , respectively .


Twenty-one healthy subjects ( @ years , @ females ) completed @ high-intensity training sessions throughout a time-period of either eight weeks ( moderate frequency , MF ) or three weeks ( high frequency , HF ) followed by a detraining period of nine weeks without any training .


In both groups , maximal oxygen uptake ( VO@max ) was evaluated before training , at the @ ( th ) and @ ( th ) session and four days after the final @ ( th ) training session .


In the detraining phase VO@max was evaluated after @ days and thereafter every second week for eight weeks .


Left ventricular echocardiography , carbon monoxide lung diffusion transfer factor , brachial artery flow mediated dilatation and vastus lateralis citrate maximal synthase activity was tested before and after training .


The cardiovascular adaptation after HF training was delayed compared to training with MF .


Four days after ending training the HF group showed no improvement ( +@ % , p = @ ) , whereas the MF group reached their highest VO@max with a @ % improvement ( p < @ : group difference p = @ ) .


The HF group reached their highest VO@max ( @ % increase , p = @ ) twelve days into the detraining period , compared to a concomitant reduction to @ % of VO@max ( p < @ ) above baseline in the MF group ( group difference p = @ ) .


Both HF and MF training of high-intensity aerobic exercise improves VO@max .


The cardiovascular adaptation following a HF programme of high-intensity exercise is however delayed compared to MF training .


Impaired arterial function has been implicated in diabetes-related atherosclerosis , but its determinants in high-risk adults have not been well characterised .


We investigated factors associated with impaired arterial function in adults with type @ diabetes .


Flow-mediated dilatation ( a marker of endothelial function ) and dilator response to glyceryl trinitrate ( to assess smooth muscle function ) of the brachial artery were assessed at baseline in @ patients with type @ diabetes from the Fenofibrate Intervention and Event Lowering in Diabetes ( FIELD ) study .


Traditional risk factors were assessed and a multivariable model was constructed to identify factors independently associated with impaired arterial function .


Median age was @ years ( interquartile range , @-@ ; @ % male ) and duration of diabetes was @ years ( interquartile range , @-@ ) .


Flow-mediated dilatation ( @ @ % , mean SEM ) was severely impaired but not significantly associated with other risk factors .


Dilator responses to glyceryl trinitrate ( @ @ % ) were significantly and independently impaired in past and present cigarette smokers ( P = @ ) and in subjects with increased urinary albumin/creatinine ratio ( P = @ ) .


In adults with type @ diabetes and known or suspected atherosclerosis , arterial smooth muscle-dependent dilatation was shown to be significantly impaired in cigarette smokers and those with elevated urinary albumin levels .


To determine whether a home-based care coordination program focused on medication self-management would affect the cost of care to the Medicare program and whether the addition of technology , a medication-dispensing machine , would further reduce cost .


Randomized , controlled , three-arm longitudinal study .


Participant homes in a large Midwestern urban area .


Older adults identified as having difficulty managing their medications at discharge from Medicare Home Health Care ( N = @ ) .


A team consisting of advanced practice nurses ( APNs ) and registered nurses ( RNs ) coordinated care for two groups : home-based nurse care coordination ( NCC ) plus a pill organizer group and NCC plus a medication-dispensing machine group .


To measure cost , participant claims data from @ to @ were retrieved from Medicare Part A and B Standard Analytical Files .


Ordinary least squares regression with covariate adjustment was used to estimate monthly dollar savings .


Total Medicare costs were $ @ per month lower in the NCC plus pill organizer group ( P = @ ) than in a control group that received usual care .


For participants in the study at least @ months , total Medicare costs were $ @ lower per month in the NCC plus pill organizer group ( P = @ ) than in the control group .


The cost of the NCC plus pill organizer intervention was $ @ per month , yielding a net savings of $ @ per month or $ @,@ per year .


The cost of the NCC plus medication-dispensing machine intervention was $ @ per month , and total Medicare costs were $ @ higher per month than in the NCC plus pill organizer group .


Nurse care coordination plus a pill organizer is a cost-effective intervention for frail elderly Medicare beneficiaries .


The addition of the medication machine did not enhance the cost effectiveness of the intervention .


Numerous animal studies and clinical trials have demonstrated that erythropoietin ( EPO ) has therapeutic effects in ischemic and degenerative diseases .


However , few clinical trials have investigated the effect of EPO in Parkinson 's disease ( PD ) patients .


This study was an exploratory pilot study to investigate the effects of recombinant human EPO ( rhEPO ) on motor and non-motor symptoms ( NMS ) in PD patients .


A total of @ PD patients at the Hanyang University Hospital were enrolled in the study .


The participants were randomly assigned to rhEPO and placebo groups .


The rhEPO group was infused intravenously ( @,@ IU each ) twice a week for @ weeks .


Clinical improvement was estimated using the Unified Parkinson 's Disease Rating Scale-III ( UPDRS-III ) , the NMS Scale ( NMSS ) and the @-Item Parkinson 's Disease Questionnaire ( PDQ-@ ) .


-LSB- ( @ ) F -RSB- N - ( @-fluoropropyl ) -@ - carbon ethoxy-@ - ( @-iodophenyl ) nortropane ( FP-CIT ) photon emission tomography ( PET ) scanning was performed on each participant at baseline and again after @ months .


The rhEPO administration significantly improved the NMSS and PDQ-@ scores at @ months .


The UPDRS-III , which reflects motor function , did not change significantly after the rhEPO treatment .


With the NMSS , the domains of cardiovascular autonomic function , sleep/fatigue , mood/cognition and attention/memory showed significant changes .


None of the participants experienced any serious adverse effects .


We found that rhEPO had beneficial effects on NMS but not on motor function .


Dopaminergic refractory NMS , such as cardiovascular autonomic dysfunction and cognition , showed improvement after the administration of rhEPO .


Our results suggest that rhEPO might be a good candidate for the treatment of NMS in PD patients .


In the present study , the potential benefits of oral carnitine in preventing antituberculosis drug-induced hepatotoxicity ( ATDH ) were evaluated .


Fifty-four patients in the carnitine and @ patients in the placebo group completed the study .


The carnitine group received @mg oral carnitine solution twice daily for @ weeks .


The placebo group received @mL of oral placebo solution twice daily for @ weeks .


ATDH was defined as an increase in the serum level of aspartate aminotransferase or alanine aminotransferase greater than three or five times of the upper limit of normal with or without clinical symptoms of hepatotoxicity , respectively .


During the study period , @ ( @ % ) patients experienced ATDH .


Among these patients , nine ( @ % ) and @ ( @ % ) were in the carnitine and placebo groups , respectively ( P = @ ) .


Based on multivariate logistic regression model , age over @ years old ( odds ratio -LSB- OR -RSB- = @ , P = @ ) , human immunodeficiency virus infection ( OR = @ , P < @ ) , diabetes mellitus ( OR = @ , P = @ ) , and placebo treatment ( OR = @ , P = @ ) were identified as predisposing factors for ATDH .


Results of our preliminary clinical trial suggested that cotreatment with @mg oral L-carnitine solution daily for @ weeks significantly decreased the rate of ATDH .


Girdles and abdominal binders may reduce pain and stabilize the abdominal wall after laparotomy , but a risk for increased intra-abdominal pressure and decreased lung function is also hypothesized .


The aim of this study was to investigate the effect of an abdominal girdle after midline laparotomy in a randomized controlled trial .


Twenty-three patients undergoing laparotomy were randomized to wear an elastic girdle postoperatively and @ were randomized to no girdle .


Pulmonary function was evaluated with ; forced vital capacity ( FVC ) , forced expiratory volume during one second ( FEV@ ) , peak expiratory flow ( PEF ) , and cough PEF .


Pain was recorded using a visual analog scale ( VAS ) .


All patients completed the ventral hernia pain questionnaire ( VHPQ ) before surgery and at the end of the study .


Intra-abdominal pressure was measured via an indwelling urinary catheter .


Wound healing was assessed from photographs .


FVC , FEV@ , PEF , and cough PEF were reduced by about @ % after surgery , but there were no differences between patients with or without a girdle ( ANOVA ) .


Intra-abdominal pressure and wound healing were the same in both groups .


Pain was significantly lower on day @ in the girdle group ( p = @ ) .


An individually fitted elastic girdle used after midline laparotomy was found to be safe , as this did not affect lung function , coughing , intra-abdominal pressure , or wound healing .


The immediate decline in lung function after surgery is restrictive and due to anesthesia and the surgical procedure .


Pain was significantly decreased in the girdle group .


The study is registered at ClinicalTrials.gov , number NCT@ .


Sexual dimorphism in plasma triglyceride ( TG ) metabolism is well established but it is unclear to what extent it is driven by differences in the sex hormone milieu .


RESULTS from previous studies evaluating the effects of sex steroids on plasma TG homeostasis are inconclusive because they relied on orally administered synthetic hormone preparations or evaluated only plasma lipid concentrations but not kinetics .


The purpose of this study was to evaluate the effects of systemically delivered @-estradiol , progesterone , and T on very low density lipoprotein-triglyceride ( VLDL-TG ) concentration and kinetics in postmenopausal women .


VLDL-TG concentration and kinetics were evaluated by using stable isotope-labeled tracer techniques in four groups of postmenopausal women ( n = @ total ) who were studied before and after treatment with either @-estradiol ( @ mg/d via continuous delivery skin patch ) , progesterone ( @ mg/d via vaginal insert ) and T ( @ mg/d via skin gel ) , or no intervention ( control group ) .


VLDL-TG concentration and kinetics were unchanged in the control group and not altered by T and progesterone administration .


Estradiol treatment , in contrast , reduced VLDL-TG concentration by approximately @ % due to accelerated VLDL-TG plasma clearance ( @ @ vs. @ @ mL/min ; P < @ ) .


Estradiol , but not progesterone or T , is a major regulator of VLDL-TG metabolism .


Ombrabulin ( AVE@ ) disrupts the vasculature of established tumours and has shown preclinical synergistic anti-tumour activity when combined with cisplatin .


In this phase @ trial , we aimed to assess the efficacy and safety of ombrabulin plus cisplatin compared with placebo plus cisplatin in patients with advanced soft-tissue sarcomas .


We did this multinational , randomised , double-blind , placebo-controlled phase @ study at @ centres in ten countries .


Patients aged @ years and older with metastatic soft-tissue sarcomas , an Eastern Cooperative Oncology Group performance status of @-@ , and who had previously received treatment with anthracycline and ifosfamide were randomly assigned ( @:@ ) to intravenous infusion of ombrabulin @ mg/m ( @ ) plus cisplatin @ mg/m ( @ ) or intravenous infusion of placebo plus cisplatin @ mg/m ( @ ) every @ weeks .


Patients were allocated to treatment using a permuted blocks randomisation scheme ( block size of four ) via an interactive voice-response system , and stratified by histological subtype .


Patients , medical staff , study investigators , and individuals who handled and analysed the data were masked to treatment assignment .


Our primary endpoint was median progression-free survival in the intention-to-treat population .


Safety analyses were done on all randomised patients who received at least one dose of study drug .


This trial is now closed , and is registered with ClinicalTrials.gov , number NCT@ .


Between June @ , @ , and April @ , @ , we randomly assigned @ patients to ombrabulin plus cisplatin ( n = @ ) or placebo plus cisplatin ( n = @ ) .


Median duration of follow-up was @ ( IQR @-@ ) in the placebo group and @ months ( @-@ ) in the ombrabulin group .


Progression-free survival was slightly , but significantly , improved in the ombrabulin group compared with the placebo group ( median @ months -LSB- @ % CI @-@ -RSB- vs @ -LSB- @-@ -RSB- months ; hazard ratio @ -LSB- @ % CI @-@ -RSB- ; p = @ ) .


Grade @ or @ adverse events occurred more frequently in individuals in the ombrabulin group than in those in the placebo group and included neutropenia ( @ -LSB- @ % -RSB- in the ombrabulin group vs @ -LSB- @ % -RSB- in the placebo group ) and thrombocytopenia ( @ -LSB- @ % -RSB- vs six -LSB- @ % -RSB- for placebo ) .


Adverse events leading to death occurred in @ patients in the ombrabulin group and @ patients in the placebo group .


The combination of ombrabulin and cisplatin significantly improved progression-free survival ; however , it did not show a sufficient clinical benefit in patients with advanced soft-tissue sarcomas to support its use as a therapeutic option .


Predictive biomarkers are needed for the rational clinical development of tumour vascular-disrupting drugs for soft-tissue sarcomas .


To compare the curative effects of heat-sensitive moxibustion with conventional drugs on chronic persistent asthma and seek a valuable therapy to replace Western Medicine .


The participants in this multi-center , randomized , and controlled study were randomly divided into two groups : group A ( n = @ ) , treated with heat-sensitive moxibustion ( @ sessions ) and group B ( n = @ ) , treated with Seretide ( salmeterol @ plg/fluticasone @ pg , twice a day ) .


The scores of asthma control test ( ACT ) , forced expiratory volume in @ second ( FEV@ ) , peak expiratory flow ( PEF ) , and attack frequency were measured after @ , @ , @ , and @ days of treatment .


Patients followed up @ and @ months after treatment .


There was a significant difference ( P = @ ) in the ACT score and lung function between the two groups after @ months of treatment and ( P = @ @ ) during the follow-up visits .


In addition , heat-sensitive moxibustion reduced attack frequency in the period from inclusion to the @-month follow-up visit .


This study shows that heat-sensitive moxibustion may have a comparable curative effect to Seretide ( salmetero/fluticasone ) on asthma .


To determine the efficacy of a custom-made wheelchair simulation in training children to use a powered wheelchair ( PWC ) .


Randomized controlled trial employing the @C/ID-model of learning .


Twenty-eight typically developing children ( @M , @F ; mean age @ years , SD @ months ) were assessed on their operation of a PWC using a functional evaluation rating scale .


Participants were randomly assigned to intervention ( @ @-minute training sessions using a joystick operated wheelchair simulation ) or control conditions ( no task ) , and were reassessed on their PWC use after the intervention phase .


Additional data from the simulation on completion times , errors , and total scores were recorded for the intervention group .


Analysis of variance showed a main effect of time , with planned comparisons revealing a statistically significant change in PWC use for the intervention ( p = @ ) but not the control condition .


Although the intervention group showed greater improvement than the controls , this did not reach statistical significance .


Multiple regression analyses showed that gender was predictive of pretest ( p = @ ) functional ability .


A simulated wheelchair task appears to be effective in helping children learn to operate a PWC .


Greater attention should be given to female learners who underperformed when compared with their male counterparts .


This low-cost intervention could be easily used at home to reduce PWC training times in children with motor disorders .


Aim of the study was to compare the chosen position of polyaxial locking screws with the position of monoaxial screws in the humeral head of proximal humeral fractures treated by locked plating .


In a prospective randomized observational study , @ consecutive patients ( mean age @ years ) sustaining a displaced proximal humeral fracture were treated with either monoaxial or polyaxial screw-inserted locking plate fixation .


The chosen positions of locking screws were identified from standardized postoperative radiographs in anteroposterior and outlet-view , with regard to a regional mapping of the humeral head .


In monoaxial locking technique , a mean of @ screws purchased the humeral head ( @ % CI @-@ @ ) , and in polyaxial locking technique , a mean of @ screws ( @ % CI @-@ @ ) , respectively .


Screws were placed in the regions superolateral : monoaxial @ % , polyaxial @ % ( p = @ ) ; superomedial : monoaxial @ % , polyaxial @ % ( p = @ ) ; inferolateral : monoaxial @ % , polyaxial @ % ( p = @ ) ; inferomedial : monoaxial @ % , polyaxial @ % ( p = @ ) , superoposterior : monoaxial @ % , polyaxial @ % ( p = @ ) ; superoanterior : monoaxial @ % , polyaxial @ % ( p = @ ) ; inferoposterior : monoaxial @ % , polyaxial @ % ( p = @ ) and inferoanterior : monoaxial @ % , polyaxial : @ % ( p = @ ) .


The chosen screws ' position in monoaxial and polyaxial locking plate fixation of displaced proximal humeral fractures do not differ significantly .


However , loss of fixation is observed more frequently if the fixation did not include at least one screw within the superoposterior region of the humeral head , suggesting that a screw purchasing the superoposterior region is beneficial in locked plating of proximal humeral fractures .


Treatment Study , Level II .


To evaluate the efficacy of a marketed oscillating-rotating ( O-R ) power toothbrush ( Oral-B Triumph with SmartGuide and FlossAction brush head , D@/EB@ ) to a new sonic toothbrush ( Sonicare FlexCare Platinum ) in the reduction of gingivitis and plaque over a @-week test period .


This was a single center , randomized , open label , examiner-blind , two-treatment , parallel group study .


Subjects who met the entrance criteria were enrolled in the study and randomly assigned to either the O-R or sonic treatment group .


Subjects brushed with their assigned toothbrush and a marketed fluoride dentifrice for two minutes twice daily at home for @ weeks .


Gingivitis and plaque were evaluated at Baseline , Week @ , and Week @ .


Gingivitis was assessed using the Modified Gingival Index ( MGI ) and Gingival Bleeding Index ( GBI ) , and plaque was assessed using the Rustogi Modified Navy Plaque Index ( RMNPI ) .


Data were analyzed using an Analysis of Covariance ( ANCOVA ) with Baseline as the covariate .


In total , @ subjects ( @ per group ) were randomized to treatment and @ subjects completed the study .


Both brushes produced statistically significant ( p < @ ) reductions in gingivitis and plaque measures relative to Baseline .


At Week @ , the O-R brush demonstrated significantly greater reductions than the sonic brush in whole mouth gingivitis measures ( p = @ ) .


Additionally , the O-R brush presented significantly fewer bleeding sites ( p < @ ) and significantly greater reductions in whole mouth plaque measures ( p < or = @ ) at Weeks @ and @ versus the sonic brush .


The benefit for the O-R brush versus the sonic brush at Week @ was @ % for gingivitis , @ % for number of bleeding sites , and @ % for whole mouth plaque .


There were no adverse events reported or observed for either brush .


The oscillating-rotating toothbrush demonstrated statistically significantly greater reductions in whole mouth plaque at Weeks @ and @ , as well as significantly greater gingivitis reductions over the long-term ( @ weeks ) , compared to the new sonic toothbrush .


The echocardiographic substudy of the OASIS-@ trial evaluated the prognostic implications of left ventricle ( LV ) systolic and diastolic dysfunction early postacute ST-segment elevation myocardial infarction ( STEMI ) in patients treated with fondaparinux versus usual care .


Comprehensive echocardiograms were performed a median of @ days after the index STEMI in @ patients , @ randomized to fondaparinux and @ to usual care ( unfractionated heparin or placebo ) , to assess LV systolic and diastolic function , LV mass , and LV end-systolic and end-diastolic volumes .


A total of @ ( @ % ) patients were followed up for @ months and @ ( @ % ) for @ months .


Major cardiac events ( MACE ) were defined as the composite of death , reinfarction , heart failure , or cardiogenic shock and resuscitated cardiac arrest .


Patients with LV ejection fraction ( LVEF ) @ % and restrictive diastolic function ( RDF ) were at greatly increased risk of MACE ( hazard ratio -LSB- HR -RSB- = @ , @ % CI , @ ) compared to patients with LVEF @ % and without RDF .


RDF remained a strong predictor for MACE in patients with LVEF @ % ( HR = @ , @ % CI , @ ) and in multivariate models adjusted for LVEF , LV end-systolic volume , and clinical variables .


In this large international trial , LV systolic and diastolic function , as determined by echocardiography early following STEMI , are incremental predictors of MACE .


In addition , RDF is a strong independent predictor of MACE after STEMI across a broad range of LVEF .


The self-reported health and functional status of persons with back pain in the United States have declined in recent years , despite greatly increased medical expenditures due to this problem .


Although patient psychosocial factors such as pain-related beliefs , thoughts and coping behaviors have been demonstrated to affect how well patients respond to treatments for back pain , few patients receive treatments that address these factors .


Cognitive-behavioral therapy ( CBT ) , which addresses psychosocial factors , has been found to be effective for back pain , but access to qualified therapists is limited .


Another treatment option with potential for addressing psychosocial issues , mindfulness-based stress reduction ( MBSR ) , is increasingly available .


MBSR has been found to be helpful for various mental and physical conditions , but it has not been well-studied for application with chronic back pain patients .


In this trial , we will seek to determine whether MBSR is an effective and cost-effective treatment option for persons with chronic back pain , compare its effectiveness and cost-effectiveness compared with CBT and explore the psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes .


In this trial , we will randomize @ adults with nonspecific chronic back pain to CBT , MBSR or usual care arms ( @ per group ) .


Both interventions will consist of eight weekly @-hour group sessions supplemented by home practice .


The MBSR protocol also includes an optional @-hour retreat .


Interviewers masked to treatment assignments will assess outcomes @ , @ , @ and @weeks postrandomization .


The primary outcomes will be pain-related functional limitations ( based on the Roland Disability Questionnaire ) and symptom bothersomeness ( rated on a @ to @ numerical rating scale ) at @weeks .


If MBSR is found to be an effective and cost-effective treatment option for patients with chronic back pain , it will become a valuable addition to the limited treatment options available to patients with significant psychosocial contributors to their pain .


Endoplasmic reticulum stress and unfolded protein response have been recently associated with the development of inflammatory bowel diseases in adults .


We aimed at assessing the involvement of these pathways also in paediatric inflammatory bowel disease by analysing the expression of the main genes involved in endoplasmic reticulum stress and correlating them with the degree of intestinal inflammation .


Real-time PCR and Western blot analysis of the expression of the endoplasmic reticulum stress marker HSPA@ and of selected genes representing the three pathways of unfolded protein response ( IRE-XBP@ , PERK-ATF@ , ATF@p@-p@ ) in inflamed and uninflamed biopsies from @ inflammatory bowel disease paediatric patients and @ controls .


HSPA@ , PDIA@ , as well as unspliced and spliced XBP@ mRNAs were significantly increased in patients ' inflamed colonic mucosa compared to uninflamed mucosa and controls .


HSPA@ , PDIA@ , ATF@ , and phospho-IRE proteins were also upregulated , indicating the activation of the IRE-XBP@ and ATF@p@-p@ branches of unfolded protein response .


A positive significant correlation between interleukin-@ levels , as a marker of inflammation , and upregulated genes was found in the inflamed colonic mucosa .


A deregulation of the genes involved in the endoplasmic reticulum stress and unfolded protein response pathways may be a key component of the inflammatory response in paediatric patients with inflammatory bowel disease .


The aims of the present study were to define the prevalence of untreated atrial fibrillation ( AF ) in a systematic screening program using intermittent ECG recordings among @ - to @-year-old individuals and to study the feasibility of initiating protective oral anticoagulant ( OAC ) treatment .


Half of the @ - to @-year-old population in @ Swedish regions were invited to a screening program for AF .


Participants without a previous diagnosis of AF underwent intermittent ECG recordings over @ weeks .


If AF was detected , participants were offered OAC .


During the @-month inclusion period , @ inhabitants were invited .


Of these , @ ( @ % ) participated .


Of the participants , @ ( @ % ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ) were found to have previously unknown AF , and of these , AF was found in @ ( @ % of the screened population ) on their first ECG .


The use of intermittent ECGs increased new AF detection @-fold .


A previous diagnosis of AF was known in @ % ( n = @ ; @ % CI , @-@ @ ) .


Total AF prevalence in the screened population was @ % .


Of participants with known AF , @ ( @ % ; @ % CI , @-@ @ ) had no OAC treatment .


In total , @ % ( @ % CI , @-@ @ ) of the screened population had untreated AF ; screening resulted in initiation of OAC treatment in @ % ( @ % CI , @-@ @ ) of the screened population .


More than @ % of the participants with previously undiagnosed AF accepted initiation of OAC treatment .


Mass screening for AF in a @ - to @-year-old population identifies a significant proportion of participants with untreated AF .


Initiation of stroke prophylactic treatment was highly successful in individuals with newly diagnosed AF .


CEREBEL compared the incidence of CNS metastases as first site of relapse in patients with human epidermal growth factor receptor @-positive metastatic breast cancer receiving lapatinib-capecitabine or trastuzumab-capecitabine .


Patients without baseline CNS metastases were randomly assigned ( @:@ ) to receive lapatinib-capecitabine ( lapatinib @,@ mg per day ; capecitabine @,@ mg/m ( @ ) per day on days @ to @ every @ days ) or trastuzumab-capecitabine ( trastuzumab loading dose of @ mg/kg followed by an infusion of @ mg/kg every @ weeks ; capecitabine @,@ mg/m ( @ ) per day on days @ to @ every @ days ) .


The primary end point was incidence of CNS metastases as first site of relapse .


Secondary end points included progression-free survival ( PFS ) and overall survival ( OS ) .


The study was terminated early with @ enrolled patients ( @ received lapatinib-capecitabine , and @ received trastuzumab-capecitabine ) .


Incidence of CNS metastases as first site of relapse was @ % ( eight of @ patients ) for lapatinib-capecitabine and @ % ( @ of @ patients ) for trastuzumab-capecitabine ( treatment differences , -@ % ; @ % CI , -@ % to @ % ; P = @ ) .


PFS and OS were longer with trastuzumab-capecitabine versus lapatinib-capecitabine ( hazard ratio -LSB- HR -RSB- for PFS , @ ; @ % CI , @ to @ ; HR for OS , @ ; @ % CI , @ to @ ) .


Serious adverse events were reported in @ % ( @ of @ patients ) and @ % ( @ of @ patients ) of patients in the lapatinib-capecitabine and trastuzumab-capecitabine arms , respectively .


CEREBEL is inconclusive for the primary end point , and no difference was detected between lapatinb-capecitabine and trastuzumab-capecitabine for the incidence of CNS metastases .


A better outcome was observed with trastuzumab-capecitabine in the overall population .


However , lapatinib-capecitabine efficacy may have been affected by previous exposure to a trastuzumab regimen and/or when treatment was given as first - or second-line therapy in the metastatic setting .


Factors underlying differential responsiveness to opioid analgesic medications used in chronic pain management are poorly understood .


We tested whether individual differences in endogenous opioid inhibition of chronic low-back pain were associated with the magnitude of acute reductions in back pain ratings after morphine administration .


In randomized counterbalanced order over three sessions , @ chronic low-back pain patients received intravenous naloxone ( @ mg ) , morphine ( @ mg/kg ) , or placebo .


Back pain intensity was rated predrug and again after peak drug activity was achieved using the McGill Pain Questionnaire-Short Form ( Sensory and Affective subscales , VAS Intensity measure ) .


Opioid blockade effect measures to index degree of endogenous opioid inhibition of back pain intensity were derived as the difference between predrug to postdrug changes in pain intensity across placebo and naloxone conditions , with similar morphine responsiveness measures derived across placebo and morphine conditions .


Morphine significantly reduced back pain compared with placebo ( McGill Pain Questionnaire-Short Form Sensory , VAS ; P < @ ) .


There were no overall effects of opioid blockade on back pain intensity .


However , individual differences in opioid blockade effects were significantly associated with the degree of acute morphine-related reductions in back pain on all measures , even after controlling for effects of age , sex , and chronic pain duration ( P < @ ) .


Individuals exhibiting greater endogenous opioid inhibition of chronic back pain intensity reported less acute relief of back pain with morphine .


Morphine appears to provide better acute relief of chronic back pain in individuals with lower natural opioidergic inhibition of chronic pain intensity .


Possible implications for personalized medicine are discussed .


The purpose of this study was to examine a dynamic assessment with graduated prompts to assess morphological awareness and determine whether such a task was related to third-grade literacy success .


A dynamic assessment of morphological awareness was adapted and administered to @ third-grade students in addition to a norm-referenced language and literacy battery .


A dynamic assessment of morphological awareness measured a range of performance including that of emerging morphological awareness abilities and provided rich linguistic insights for how best to scaffold and prompt for such a skill .


In addition , the dynamic morphological awareness measure was found to be significantly related to , and to contribute unique variance to , reading comprehension abilities .


These results suggest that morphological awareness is an important factor to consider when addressing students ' literacy performance in early elementary school and that dynamic assessment appears to be a clinically valuable tool when examining early morphological awareness abilities .


Esophagogastrostomy for oesophageal cancer is the standard surgical treatment .


However , traditional techniques have been associated with high frequency of anastomotic complications .


The purpose of this study is to clarify the superiority of the oesophageal flap valvuloplasty and wrapping suturing technique in preventing postoperative complications after oesophagectomy for oesophageal cancer .


A prospective , randomised study was performed on @ patients treated for esophageal cancer between January @ and December @ .


The trial registry number is ChiCTR-TRC-@ in the Chinese Clinical Trial Registry .


Anastomotic leaks occurred in four patients in group A ( @ % ) and in twelve patients in group B ( @ % ) with statistically significant ( P = @ ) .


During the evaluation of benign stricture seven patients were excluded for hospital mortality .


Thirty three patients in group A ( @ % ) and @ patients in group B ( @ % ) occurred anastomotic stricture respectively ( P = @ ) .


Furthermore , reflux oesophagitis and Barrett 's epithelium were found in @ patients ( @ % ) of group B , and @ ( @ % ) patients in group A ( P < @ ) .


The oesophageal flap valvuloplasty and wrapping suturing technique decreased anastomotic leakage incidence and stricture rate thereby decreasing the morbidity and mortality .


This procedure also prevented the occurrence of gastroesophageal reflux after esophagectomy .


Ultrasound-guided long-axis in-plane sciatic perineural catheter insertion has been described but not validated .


For the popliteal-sciatic nerve , we hypothesized that a long-axis in-plane technique , placing the catheter parallel and posterior to the nerve , results in faster onset of sensory anesthesia compared to a short-axis in-plane technique .


Preoperatively , patients receiving a popliteal-sciatic perineural catheter were randomly assigned to either the long-axis or short-axis technique .


Mepivacaine @ % was administered via the catheter following insertion .


The primary outcome was time to achieve complete sensory anesthesia .


Secondary outcomes included procedural time , onset time of motor block , and pain on postoperative day @ .


Fifty patients were enrolled .


In the long-axis group ( n = @ ) , all patients except @ ( @ % ) had successful catheter placement per protocol .


Two patients ( @ % ) in the long-axis group and @ patient ( @ % ) in the short-axis group ( n = @ ) did not achieve sensory anesthesia by @ min and were withdrawn .


Seventeen of @ ( @ % ) and @ of @ ( @ % ) patients in the short-axis and long-axis groups , respectively , achieved the primary outcome of complete sensory anesthesia ( p = @ ) .


The short-axis group ( n = @ ) required a median ( @th-@th ) of @ ( @-@ @ ) min compared to @ ( @-@ @ ) min for the long-axis group ( n = @ , p = @ ) to achieve complete sensory anesthesia .


Procedural time was @ ( @-@ @ ) min for the short-axis and @ ( @-@ @ ) min for the long-axis ( p < @ ) group .


There were no statistically significant differences in other secondary outcomes .


Long-axis in-plane popliteal-sciatic perineural catheter insertion requires more time to perform compared to a short-axis in-plane technique without demonstrating any advantages .


Although the analgesic effect of periarticular injection after total knee arthroplasty ( TKA ) has been well documented , the gold standard for drug combination has not yet been established .


In this study , the analgesic effects of six different drug combinations were compared .


A total of @ patients undergoing TKA for primary osteoarthritis were randomized into one of six groups : a control group ( saline solution , epinephrine , and cefazolin , n = @ ) , Group @ ( ropivacaine , n = @ ) , Group @ ( ropivacaine + morphine , n = @ ) , Group @ ( ropivacaine + ketorolac , n = @ ) , Group @ ( ropivacaine + morphine + ketorolac , n = @ ) , and Group @ ( ropivacaine + morphine + ketorolac + methylprednisolone , n = @ ) .


Pain level assessed by visual analogue scale ( VAS ) and opioid consumption were primary outcomes .


The incidence of complications , range of motion ( ROM ) , C-reactive protein ( CRP ) value , and the amount of post-operative blood drainage were also compared .


Patients in Groups @ and @ complained less pain than the control group for the first @ h after surgery , and the patients in the other groups showed less pain only during the initial @ h after surgery .


Groups @ and @ also showed less opioid consumption than the control group during the @ h period after surgery .


Patients in Group @ showed no significant difference in VAS score and opioid consumption compared with Group @ , but they had lower CRP value and greater ROM than any other groups at post-operative day @ and day @ .


The combination of ropivacaine , morphine , and ketorolac showed a significantly stronger and sufficiently synergistic analgesic effect without adding methylprednisolone in periarticular injection after TKA .


The clinical relevance of the study is that the combination of ropivacaine , morphine , and ketorolac can be a good option for periarticular injection following TKA in terms of synergistic analgesic effect and efficiency of drug combination .


Secukinumab has demonstrated high , sustained efficacy in psoriasis to @ weeks on a fixed-interval regimen .


We sought to compare a retreatment-as-needed versus a fixed-interval regimen .


In this double-blind study , adults with moderate to severe plaque psoriasis were randomized @:@ to subcutaneous secukinumab at @ mg ( n = @ ) or @ mg ( n = @ ) weekly from baseline until week @ , and at week @ .


At week @ , patients achieving @ % or more improvement from baseline Psoriasis Area and Severity Index score ( PASI @ ) were rerandomized to @ dose levels of secukinumab retreatment as needed ( n = @ , @ mg ; n = @ , @ mg ) or fixed interval ( n = @ ; n = @ ) .


Primary end point was noninferiority of retreatment as needed versus fixed interval for maintaining PASI @ to week @ .


Secukinumab induced high responses by week @ ( @ % -@ % PASI @ responders ) .


From week @ to week @ , more patients on fixed interval ( @ % , @ mg ; @ % , @ mg ) maintained PASI @ versus retreatment as needed ( @ % ; @ % ) ; statistical noninferiority of retreatment as needed was not established .


Overall safety , including very low incidences of treatment-emergent anti-drug antibodies ( < @ % ) , was similar between regimens .


The primary end point was developed without any known precedent .


Secukinumab fixed interval showed clear benefit versus the study-specified retreatment-as-needed regimen for maintaining efficacy .


Both regimens exhibited safety consistent with previous trials .


The potential of retreatment as needed with secukinumab warrants further investigation .


The purpose of this study was to quantify the frequency and clinical severity of quality deficiencies in intensity modulated radiation therapy ( IMRT ) planning in the Radiation Therapy Oncology Group @ protocol .


A total of @ IMRT patients from the high-dose arm ( @ Gy ) of RTOG @ were analyzed .


To quantify plan quality , we used established knowledge-based methods for patient-specific dose-volume histogram ( DVH ) prediction of organs at risk and a Lyman-Kutcher-Burman ( LKB ) model for grade @ rectal complications to convert DVHs into normal tissue complication probabilities ( NTCPs ) .


The LKB model was validated by fitting dose-response parameters relative to observed toxicities .


The @th percentile ( @ of @ ) of plans with the lowest excess risk ( difference between clinical and model-predicted NTCP ) were used to create a model for the presumed best practices in the protocol ( pDVH@ , top@ % ) .


Applying the resultant model to the entire sample enabled comparisons between DVHs that patients could have received to DVHs they actually received .


Excess risk quantified the clinical impact of suboptimal planning .


Accuracy of pDVH predictions was validated by replanning @ of @ patients ( @ % ) , including equal numbers of presumed `` high-quality , '' `` low-quality , '' and randomly sampled plans .


NTCP-predicted toxicities were compared to adverse events on protocol .


Existing models showed that bladder-sparing variations were less prevalent than rectum quality variations and that increased rectal sparing was not correlated with target metrics ( dose received by @ % and @ % of the PTV , respectively ) .


Observed toxicities were consistent with current LKB parameters .


Converting DVH and pDVH@ , top@ % to rectal NTCPs , we observed @ of @ patients ( @ % ) with @ % excess risk , @ of @ patients ( @ % ) with @ % excess risk , and @ of @ patients ( @ % ) with @ % excess risk .


Replanning demonstrated the predicted NTCP reductions while maintaining the volume of the PTV receiving prescription dose .


An equivalent sample of high-quality plans showed fewer toxicities than low-quality plans , @ of @ versus @ of @ respectively , although these differences were not significant ( P = @ ) due to insufficient statistical power in this retrospective study .


Plan quality deficiencies in RTOG @ exposed patients to substantial excess risk for rectal complications .


Transfer patterns , procedure rates , and outcomes of patients with non-ST-segment elevation myocardial infarction ( NSTEMI ) presenting to Canadian community hospitals are not well understood .


We documented all patients admitted to British Columbia ( BC ) hospitals with a primary diagnosis of NSTEMI between @ and @ .


Patients were divided by admitting hospital type into tertiary care hospitals , nonremote community hospitals , and remote community hospitals .


The aims were to compare transfer rates and time to transfer to a tertiary hospital as well as procedure rates and outcomes at index admission , at @ days , and at @ year .


The mean transfer rates to a tertiary hospital were @ % for nonremote and @ % for remote community hospitals ( P < @ ) .


Times to and rates of cardiac procedures differed significantly among these @ hospital types .