To compare the performance of three continence management devices and absorbent pads used by men with persistent urinary incontinence ( > 1year ) after treatment for prostate cancer .


Randomised , controlled trial of 56 men with 1-year follow-up .


Three devices were tested for 3weeks each : sheath drainage system , body-worn urinal ( BWU ) and penile clamp .


Device and pad performance were assessed .


Quality of life ( QoL ) was measured at baseline and follow-up with the King 's Health Questionnaire .


Stated ( intended use ) and revealed ( actual use ) preference for products were assessed .


Value-for-money was gathered .


Substantial and significant differences in performance were found .


The sheath was rated as ` good ' for extended use ( e.g. golf and travel ) when pad changing is difficult ; for keeping skin dry , not leaking , not smelling and convenient for storage and travel .


The BWU was generally rated worse than the sheath and was mainly used for similar activities but by men who could not use a sheath ( e.g. retracted penis ) and was not good for seated activities .


The clamp was good for short vigorous activities like swimming/exercise ; it was the most secure , least likely to leak , most discreet but almost all men described it as uncomfortable or painful .


The pads were good for everyday activities and best for night-time use ; most easy to use , comfortable when dry but most likely to leak and most uncomfortable when wet .


There was a preference for having a mixture of products to meet daytime needs ; around two-thirds of men were using a combination of pads and devices after testing compared with baseline .


This is the first trial to systematically compare different continence management devices for men .


Pads and devices have different strengths , which make them particularly suited to certain circumstances and activities .


Most men prefer to use pads at night but would choose a mixture of pads and devices during the day .


Device limitations were important but may be overcome by better design .


Lipid-based nutrient supplements ( LNS ) have been effective in the treatment of acute malnutrition among children .


We evaluated the use of LNS supplementation for improving the micronutrient status of young children .


A 12-month randomised controlled trial was conducted among children aged 6-18 months living in Intibuc , Honduras .


Communities ( n = 18 ) were randomised into clusters matched by poverty indicators ( 9 intervention , n = 160 and 9 controls , n = 140 ) .


Intervention participants received LNS .


All children received food vouchers and nutrition education .


Primary outcomes included measures of micronutrient status : at baseline , 6 and 12 months ' blood were collected for assessment of folate , iron , zinc , riboflavin , and vitamin B12 status ; haemoglobin was measured every 3 months ; and dietary and anthropometry collected monthly .


Longitudinal analyses were based on intent to treat and LNS adherence .


Generalised estimating equations were used in the estimation of generalised linear regression models specified for the data .


At 6-month follow-up , children in the intervention group had a lower proportion classified as deficient for B12 ( 43.6 % ) compared with the control ( 67.7 % ; P = 0.03 ) .


The intervention group had a higher mean concentration for folate at 6 months ( P = 0.06 ) , and improvements continued through 12 months for folate ( P = 0.002 ) and vitamin A deficiency ( P = 0.03 ) .


This pattern of results , with improved significance , remained in subanalysis based on LNS adherence .


These data demonstrate that LNS improved select micronutrient status in young non-malnourished Honduran children .


Diesel exhaust ( DE ) exposures are very common , yet exposure-related symptoms have n't been rigorously examined .


Describe symptomatic responses to freshly generated and diluted DE and filtered air ( FA ) in a controlled human exposure setting ; assess whether such responses are altered by perception of exposure .


43 subjects participated within three double-blind crossover experiments to order-randomized DE exposure levels ( FA and DE calibrated at 100 and/or 200 micrograms/m ( 3 ) particulate matter of diameter less than 2.5 microns ) , and completed questionnaires regarding symptoms and dose perception .


For a given symptom cluster , the majority of those exposed to moderate concentrations of diesel exhaust do not report such symptoms .


The most commonly reported symptom cluster was of the nose ( 29 % ) .


Blinding to exposure is generally effective .


Perceived exposure , rather than true exposure , is the dominant modifier of symptom reporting .


Controlled human exposure to moderate-dose diesel exhaust is associated with a range of mild symptoms , though the majority of individuals will not experience any given symptom .


Blinding to DE exposure is generally effective .


Perceived DE exposure , rather than true DE exposure , is the dominant modifier of symptom reporting .


Electrobrasion , like dermabrasion , is a method of surgical planing that is purported to improve postoperative scarring .


Data regarding its benefits and harms relative to dermabrasion are absent .


To compare the efficacy and potential harms of electrobrasion and dermabrasion .


This was a pragmatic , randomized , double-blind , split-scar intervention in patients with suboptimal surgical outcomes .


Half of the wound was randomized to treatment with dermabrasion and half to electrobrasion .


At 3-month follow-up , both the patient and a blinded investigator evaluated the wound .


Electrobrasion and dermabrasion reduced the mean scores of the Manchester Scar Scale 16 and 13 points from baseline , respectively ( P = 00003 ) .


The difference between treatments was not significant ( P = 008 ) .


Global cosmetic improvement by physician and patient assessment indicated clinical improvement for both procedures but did not demonstrate statistical significance between treatments ( P = 057 , P = 032 for physician and patient , respectively ) .


Both dermabrasion and electrobrasion improved scars , but there was no significant difference between the outcomes of the two procedures on several measures .


Procedure time and bleeding time were significantly lower for electrobrasion .


This study was designed to investigate the effects of omega-3 fatty acids on depression and chronic inflammation in hemodialysis patients .


Fifty-four maintenance hemodialysis patients were randomized to ingest two omega-3 ( each containing 180 mg eicosapentaenoic acid and 120 mg docosahexaenoic acid ) or placebo capsules , three times daily for 4 months .


Beck Depression Inventory ( BDI ) score and serum levels of C-reactive protein ( CRP ) , interleukin ( IL ) -6 , IL-10 , tumor necrosis factor ( TNF ) - , ferritin , intact parathyroid hormone ( iPTH ) , and ratios of IL-10 to IL-6 and IL-10 to TNF - were measured at baseline and at the end of the study .


Omega-3 supplement lowered BDI score significantly after 4 months of intervention .


Among pro- and anti-inflammatory mediators , only serum ferritin level and IL-10 to IL-6 ratio showed significant changes in favor of omega-3 supplement during the study .


In linear regression model adjusted for baseline values , omega-3 treatment was a significant predictor of reduced serum CRP , ferritin , and iPTH levels , and increased IL-10 to IL-6 ratio .


No significant association was found between the anti-inflammatory and anti-depressant effects of omega-3 supplement .


Supplemental use of omega-3 fatty acids decreases depressive symptoms in hemodialysis patients apart from their anti-inflammatory effects .


Skin-to-skin contact ( SSC ) between mother and infant , commonly referred to as Kangaroo Mother Care ( KMC ) , is recommended as an intervention for procedural pain .


Evidence demonstrates its consistent efficacy in reducing pain for a single painful procedure .


The purpose of this study is to examine the sustained efficacy of KMC , provided during all routine painful procedures for the duration of Neonatal Intensive Care Unit ( NICU ) hospitalization , in diminishing behavioral pain response in preterm neonates .


The efficacy of KMC alone will be compared to standard care of 24 % oral sucrose , as well as the combination of KMC and 24 % oral sucrose .


Infants admitted to the NICU who are less than 36 6/7 weeks gestational age ( according to early ultrasound ) , that are stable enough to be held in KMC , will be considered eligible ( N = 258 ) .


Using a single-blinded randomized parallel group design , participants will be assigned to one of three possible interventions : 1 ) KMC , 2 ) combined KMC and sucrose , and 3 ) sucrose alone , when they undergo any routine painful procedure ( heel lance , venipuncture , intravenous , oro/nasogastric insertion ) .


The primary outcome is infant 's pain intensity , which will be assessed using the Premature Infant Pain Profile ( PIPP ) .


The secondary outcome will be maturity of neurobehavioral functioning , as measured by the Neurobehavioral Assessment of the Preterm Infant ( NAPI ) .


Gestational age , cumulative exposure to KMC provided during non-pain contexts , and maternal cortisol levels will be considered in the analysis .


Clinical feasibility will be accounted for from nurse and maternal questionnaires .


This will be the first study to examine the repeated use of KMC for managing procedural pain in preterm neonates .


It is also the first to compare KMC to sucrose , or the interventions in combination , across time .


Based on the theoretical framework of the brain opioid theory of attachment , it is expected that KMC will be a preferred standard of care .


However , current pain management guidelines are based on minimal data on repeated use of either intervention .


Therefore , regardless of the outcomes of this study , results will have important implications for guidelines and practices related to management of procedural pain in preterm infants .


ClinicalTrials.gov Identifier : NCT01561547 .


Schools are considered an attractive setting to promote healthy living behaviors in children , but previous school-based interventions aimed at preventing weight gain in children have yielded mixed results .


Novel school-based approaches are needed to modify healthy living behaviors and attenuate weight gain in children .


To assess the effectiveness of a peer-led healthy living program called Healthy Buddies on weight gain and its determinants when disseminated at the provincial level to elementary school students .


Cluster-randomized effectiveness trial performed during the 2009-2010 school year .


Baseline and follow-up measurements were made in October 2009 and May 2010 , respectively .


The study was performed in 19 elementary schools in Manitoba , Canada , and included 647 elementary school students aged 6 to 12 years ( 48 % girls ) .


Schools were randomized to receive regular curriculum or Healthy Buddies lesson plans .


Lesson plans were delivered by older ( 9 - to 12-year-old ) elementary school students to the younger ( 6 - to 8-year-old ) peers and targeted 3 components of health : physical activity , healthy eating , and self-esteem and body image .


The primary outcome measures were the change in waist circumference and body mass index z score .


Secondary outcomes included physical activity ( steps per day ) , cardiorespiratory fitness , self-efficacy , healthy living knowledge , and self-reported dietary intake .


At baseline , 36 % of children were overweight or obese and 11 % achieved the recommended 13,500 steps per day .


Intention-to-treat analyses showed that waist circumference declined significantly in the intervention group relative to controls : -1.42 cm ( -2.68 to -0.17 ; P = .03 ) .


Reductions in waist circumference were particularly significant for children who were younger , overweight or obese , or attending First Nations schools .


No difference in body mass index z score was observed between groups .


Self-efficacy , healthy living knowledge , and dietary intake significantly improved in younger peers who received the intervention compared with students from control schools .


No differences were observed in daily step counts or cardiorespiratory fitness between the groups .


The implementation of Healthy Buddies lesson plans delivered by older peers within an elementary school setting is an effective method for attenuating increases in central adiposity and improving knowledge of healthy living behaviors among elementary school students .


Improvements were achieved with parallel improvements in diet quality , self-efficacy , and knowledge of healthy living .


clinicaltrials.gov Identifier : NCT01979978 .


Acute kidney injury is common in hospitalized patients , increases morbidity and mortality , and is under-recognized .


To improve provider recognition , we previously developed an electronic alert system for acute kidney injury .


To test the hypothesis that this electronic acute kidney injury alert could improve patient outcome , we designed a randomized controlled trial to test the effectiveness of this alert in hospitalized patients .


The study design presented several methodologic , ethical , and statistical challenges .


To highlight the challenges faced and the solutions employed in the design and implementation of a clinical trial to determine whether the provision of an early electronic alert for acute kidney injury would improve outcomes in hospitalized patients .


Challenges included how to randomize the delivery of the alert system and the ethical framework for waiving informed consent .


Other methodologic challenges included the selection and statistical evaluation of our study outcome , a ranked-composite of a continuous covariate ( creatinine ) and two dichotomous outcomes ( dialysis and death ) , and the use of the medical record as a source of trial data .


We have designed a randomized trial to assess the effectiveness of an electronic alert system for acute kidney injury .


With broad inclusion criteria , and a waiver of informed consent , we enroll and randomize virtually every patient with acute kidney injury in our hospital .


As of 31 March 2014 , we have enrolled 2373 patients of 2400 targeted .


Pre-alert data demonstrated a strong association between severity of acute kidney injury and inpatient mortality with a range of 6.4 % in those with mild , stage 1 acute kidney injury , to 29 % among those with stage 3 acute kidney injury ( p < 0.001 ) .


We judged that informed consent would undermine the scientific validity of the study and present harms that are out of proportion to the very low risk intervention .


Our study demonstrates the feasibility of designing an ethical randomized controlled trial of an early electronic alert for acute kidney injury without obtaining informed consent from individual participants .


Our study outcome may serve as a model for other studies of acute kidney injury , insofar as our paradigm accounts for the effect that early death and dialysis have on assessment of acute kidney injury severity as defined by maximum achieved serum creatinine .


To compare transjugular intrahepatic portosystemic shunt ( TIPS ) placement with or without variceal embolization with endoscopic band ligation ( EBL ) plus propranolol in preventing recurrent esophageal variceal bleeding in patients with advanced cirrhosis and portal vein thrombosis .


The present randomized controlled trial was approved by the ethics committee board of West China Hospital .


Written informed consent was obtained from each patient .


Between January 2010 and December 2012 , 73 patients were randomly allocated to receive TIPS ( n = 37 ) or EBL plus propranolol ( n = 36 ) .


The comparisons of recurrent variceal bleeding , hepatic encephalopathy , and survival rates were based on the Kaplan-Meier method and were compared using the log-rank test .


The mean follow-up time was 22.8 months 7.7 ( standard deviation ) in the TIPS group and 20.9 months 8.9 in the EBL group .


The 2-year probability of remaining free of recurrent variceal bleeding was higher in the TIPS group ( 77.8 % ) than in the EBL group ( 42.9 % ) ( P = .002 ) .


Overall recanalization was achieved in 24 ( 64.9 % ) patients from the TIPS group and seven ( 19.4 % ) patients from the EBL group .


The hepatic encephalopathy rates exhibited no significant differences between the two groups ( P = .53 ) .


The 1 - and 2-year probability of survival was 86.5 % and 72.9 % , respectively , in the TIPS group and 83.3 % and 57.2 % , respectively , in the EBL group , with no significant difference ( P = .23 ) .


TIPS was more effective than EBL plus propranolol in preventing recurrent esophageal variceal bleeding in patients with advanced cirrhosis and portal vein thrombosis and did not increase the incidence of hepatic encephalopathy .


Survival was similar in both groups .


To evaluate the efficacy and safety of two low-dose levonorgestrel intrauterine contraceptive systems .


Nulliparous and parous women aged 18-35 years with regular menstrual cycles ( 21-35 days ) requesting contraception were randomized to 3 years of treatment with one of two levonorgestrel intrauterine contraceptive systems : 13.5 mg total content or 19.5 mg total content .


The primary outcome was the pregnancy rate , calculated as the Pearl Index .


Overall , 1,432 and 1,452 women in the 13.5 mg intrauterine contraceptive system and 19.5 mg intrauterine contraceptive system groups , respectively , had a placement attempted and were included in the full analysis set to evaluate efficacy and safety .


Mean ( standard deviation ) age was 27.1 ( 4.8 ) years ; 39.2 % were nulliparous .


Over the 3-year study period , 0.33 pregnancies per 100 women-years ( 95 % confidence interval [ CI ] 0.16-0 .60 ) were observed with the 13.5 mg intrauterine contraceptive system compared with 0.31 per 100 women-years ( 95 % CI 0.15-0 .57 ) with the 19.5 mg intrauterine contraceptive system .


Kaplan-Meier estimates for that period were 0.009 and 0.010 , respectively .


At least partial expulsions occurred in 4.56 % and 3.58 % and discontinuation rates resulting from a reported adverse event occurred in 21.9 % and 19.1 % , respectively .


Ten of the 20 pregnancies were ectopic .


Serious adverse events included six cases of pelvic inflammatory disease and one partial uterine perforation .


Both lower-dose levonorgestrel intrauterine contraceptive systems were highly effective for 3 years of use and generally well tolerated .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT00528112 .


: I.


Extracorporeal shock wave lithotripsy ( SWL ) is a wide spread option for the treatment of the upper urinary tract urolithiasis .


EAU guideline recommends the treatment with 60-90 shots per minute for the optimal frequency of SWL , but there is no report on the efficiency of SWL with the frequency less than 60 shots per minute .


To determine the optimal shock wave frequency of SWL , we prospectively randomized total 247 patients with ureteral stone to the four different treatment groups : group A ( 76 pts . )


, group B ( 68 pts . )


, group C ( 55 pts . )


and group D ( 48 pts . )


These groups were treated with the frequencies of 80 , 60 , 45 and 30 shots per minute respectively using Dornier Lithotripter D.


One treatment took forty minutes , resulting in the total shock waves per session of 3,200 , 2,400 , 1,800 and 1,200 for group A , B , C and D , respectively .


The total numbers of the SWL sessions were statistically not different among the four groups .


Importantly , there was statistically no difference among the four groups about the stone clearance rates and the stone reduction efficiencies on the next day , after one week and after one month of the treatment .


In addition , only two additional ureteral stenting for pyelonephritis and one renal subcapsular hematoma were observed .


This study suggests that the efficiency of SWL with the frequency of 30 or 45 shots per minute is similar to that of 60 or 80 shots for stone reduction and clearance .


Insulin resistance plays an important role in the pathophysiology in chronic heart failure ( CHF ) .


Diuretics generally have harmful effects on glucose metabolism , however , the effect of mineral corticoid receptor blockers on insulin resistance in CHF is unclear .


This study aimed to evaluate the effects of the aldosterone blocker spironolactone , in comparison with furosemide , on insulin resistance in CHF patients .


The effect of spironolactone ( 25mg/day ) and furosemide ( 20mg/day ) on IR for 16 weeks each was analyzed in 16 CHF patients using a double-blind , placebo-controlled , randomized cross-over study design .


Plasma BNP and left ventricular ejection fraction were improved with both treatments ( furosemide : p = 0.02 and p = 0.009 , respectively , spironolactone : p = 0.03 and p = 0.007 , respectively ) .


Fasting plasma glucose was not changed ; however , plasma insulin levels decreased and insulin sensitivity ( by homeostasis model assessment : HOMA-IR ) improved with spironolactone as compared to furosemide ( p < 0.0005 ) .


TNF - , IL-6 and MCP-1 decreased with spironolactone ( p = 0.002 , p = 0.02 and p = 0.02 vs. baseline , respectively ) , but not with furosemide .


Matrix metalloproteinase ( MMP ) -2 and MMP-9 were decreased with spironolactone ( p = 0.003 and p = 0.04 vs. baseline , respectively ) , but not furosemide .


Changes in TNF - , IL-6 and MCP-1 levels after spironolactone treatment were significantly correlated with changes in HOMA-IR ( r = 0.61 , r = 0.55 and r = 0.65 , respectively ; p = 0.01 , p = 0.03 and p = 0.01 , respectively ) .


Furthermore , changes in MMP-2 and MMP-9 levels were significantly correlated with changes in HOMA-IR ( r = 0.58 and r = 0.58 , respectively ; p = 0.02 and p = 0.02 , respectively ) .


Spironolactone , not furosemide , improved insulin resistance in CHF patients probably by the inhibition of inflammatory cytokines and MMPs .


The FAST ( food allergy-specific immunotherapy ) project aims at developing safe and effective subcutaneous immunotherapy for fish allergy , using recombinant hypoallergenic carp parvalbumin , Cyp c 1 .


Preclinical characterization and good manufacturing practice ( GMP ) production of mutant Cyp ( mCyp ) c 1 .


Escherichia coli-produced mCyp c 1 was purified using standard chromatographic techniques .


Physicochemical properties were investigated by gel electrophoresis , size exclusion chromatography , circular dichroism spectroscopy , reverse-phase high-performance liquid chromatography and mass spectrometry .


Allergenicity was assessed by ImmunoCAP inhibition and basophil histamine release assay , immunogenicity by immunization of laboratory animals and stimulation of patients ' peripheral blood mononuclear cells ( PBMCs ) .


Reference molecules were purified wild-type Cyp c 1 ( natural and/or recombinant ) .


GMP-compliant alum-adsorbed mCyp c 1 was tested for acute toxicity in mice and rabbits and for repeated-dose toxicity in mice .


Accelerated and real-time protocols were used to evaluate stability of mCyp c 1 as drug substance and drug product .


Purified mCyp c 1 behaves as a folded and stable molecule .


Using sera of 26 double-blind placebo-controlled food-challenge-proven fish-allergic patients , reduction in allergenic activity ranged from 10 - to 5,000-fold ( 1,000-fold on average ) , but with retained immunogenicity ( immunization in mice/rabbits ) and potency to stimulate human PBMCs .


Toxicity studies revealed no toxic effects and real-time stability studies on the Al ( OH ) 3-adsorbed drug product demonstrated at least 20 months of stability .


The GMP drug product developed for treatment of fish allergy has the characteristics targeted for in FAST : i.e. hypoallergenicity with retained immunogenicity .


These results have warranted first-in-man immunotherapy studies to evaluate the safety of this innovative vaccine .


We evaluated the effect of alvimopan treatment vs placebo on health care utilization and costs related to gastrointestinal recovery in patients treated with radical cystectomy in a randomized , phase 4 clinical trial .


Resource utilization data were prospectively collected and evaluated by cost consequence analysis .


Hospital costs were estimated from 2012 Medicare reimbursement rates and medication wholesale acquisition costs .


Differences in base case mean costs between the study cohorts for total postoperative ileus related costs ( hospital days , study drug , nasogastric tubes , postoperative ileus related concomitant medication and postoperative ileus related readmissions ) and total combined costs ( postoperative ileus related , laboratory , electrocardiograms , nonpostoperative ileus related concomitant medication and nonpostoperative ileus related readmission ) were evaluated by probabilistic sensitivity analysis using a bootstrap approach .


Mean hospital stay was 2.63 days shorter for alvimopan than placebo ( meanSD 8.443.05 vs 11.078.23 days , p = 0.005 ) .


Use of medications or interventions likely intended to diagnose or manage postoperative ileus was lower for alvimopan than for placebo , eg total parenteral nutrition 10 % vs 25 % ( p = 0.001 ) .


Postoperative ileus related health care costs were $ 2,340 lower for alvimopan and mean total combined costs were decreased by $ 2,640 per patient for alvimopan vs placebo .


Analysis using a 10,000-iteration bootstrap approach showed that the mean difference in postoperative ileus related costs ( p = 0.04 ) but not total combined costs ( p = 0.068 ) was significantly lower for alvimopan than for placebo .


In patients treated with radical cystectomy alvimopan decreased hospitalization cost by reducing the health care services associated with postoperative ileus and decreasing the hospital stay .


The feasibility of applying the Fit fOR The Aged ( FORTA ) list , a drug classification combining positive and negative labeling of drugs , should be studied in geriatric patients and medication quality and clinical endpoints measured .


FORTA labels range from A ( indispensable ) , B ( beneficial ) , C ( questionable ) to D ( avoid ) .


A prospective randomized controlled pilot trial was performed in hospitalized geriatric patients in whom the FORTA instrument or standard care was applied .


Patients were randomly admitted to an intervention and a control ward .


Changes of FORTA label distributions between admission and discharge , over - and under-prescription rates , clinical endpoints including the number of falls during the hospitalization , and Barthel Index ( BI ) at admission and discharge were measured .


Polypharmacy persisted in both groups .


At discharge , a higher rate of A drugs was prescribed in the intervention group ( 58 patients , median age 84 years ) vs. standard care ( 56 patients , median age 83 years , p < 0.02 ) , and both over - and under-prescriptions were significantly lower in the FORTA than in the control group ( p < 0.03 ) .


Two ( 3.4 % ) intervention , but 12 ( 21.4 % ) control , patients fell at least once ( p < 0.001 ) .


The fall rate per 1,000 patient years was 1.58.3 in the intervention and 10.625.4 in the control group ( p < 0.004 ) .


This pilot study shows that the application of the FORTA list is feasible in geriatric patients .


In this small study , the medication quality improved in the intervention group , but polypharmacy persisted in both groups .


The fall rate was significantly lower in the intervention group .


These encouraging results must be interpreted carefully .


The use of highly crosslinked polyethylene ( HXLPE ) is now commonplace for total hip arthroplasty .


Hip simulator studies and short-term in vivo measurements suggest that the wear rate of some types of HXLPE is significantly less than conventional ultrahigh-molecular-weight polyethylene ( UHMWPE ) .


However , there are few long-term data to support its use .


The aim of this study was to measure the long-term steady-state wear of HXLPE compared with UHMWPE liners in a prospective , double-blind , randomized controlled trial using radiostereometric analysis .


Fifty-four patients were randomized to receive hip arthroplasties with either UHMWPE liners or HXLPE liners .


Complete followup was available on 39 of these patients ( 72 % ) .


All patients received the same cemented stem and an uncemented acetabular component .


Three-dimensional penetration of the head into the socket was determined at 10 years using a radiostereometric analysis system , which has an in vivo accuracy of < 0.1 mm .


Oxford Hip Scores were compared between the groups .


At 10 years there was significantly less wear of HXLPE ( 0.003 mm/year ; 95 % confidence interval [ CI ] , 0.010 ; SD 0.023 ; range , -0.057 to 0.074 ) compared with UHMWPE ( 0.030 mm/year ; 95 % CI , 0.012 ; p < 0.001 ; SD 0.0.27 ; range , -0.001 to 0.164 ) .


The volumetric penetration from 1 to 10 years for the UHMWPE group was 98 mm3 ( 95 % CI , 46 mm3 ; SD 102 mm3 ; range , -4 to 430 mm3 ) compared with 14 mm3 ( 95 % CI , 40 mm3 ; SD 91 mm3 ; range , -189 to 242 mm3 ) for the HXLPE group ( p = 0.01 ) .


This study demonstrates that HXLPE has little detectable steady-state in vivo wear .


This may result in fewer reoperations from loosening ; however , careful clinical followup into the second decade still needs to be performed .


Level I , therapeutic study .


See the Guidelines for Authors for a complete description of levels of evidence .


To determine whether some participants in the Diabetes Prevention Program were more or less likely to benefit from metformin or a structured lifestyle modification program .


Post hoc analysis of the Diabetes Prevention Program , a randomized controlled trial .


Ambulatory care patients .


3060 people without diabetes but with evidence of impaired glucose metabolism .


Intervention groups received metformin or a lifestyle modification program with the goals of weight loss and physical activity .


Development of diabetes , stratified by the risk of developing diabetes according to a diabetes risk prediction model .


Of the 3081 participants with impaired glucose metabolism at baseline , 655 ( 21 % ) progressed to diabetes over a median 2.8 years ' follow-up .


The diabetes risk model had good discrimination ( C statistic = 0.73 ) and calibration .


Although the lifestyle intervention provided a sixfold greater absolute risk reduction in the highest risk quarter than in the lowest risk quarter , patients in the lowest risk quarter still received substantial benefit ( three year absolute risk reduction 4.9 % v 28.3 % in highest risk quarter ; numbers needed to treat of 20.4 and 3.5 , respectively ) .


The benefit of metformin , however , was seen almost entirely in patients in the top quarter of risk of diabetes .


No benefit was seen in the lowest risk quarter .


Participants in the highest risk quarter averaged a 21.4 % three year absolute risk reduction ( number needed to treat 4.6 ) .


Patients at high risk of diabetes have substantial variation in their likelihood of receiving benefit from diabetes prevention treatments .


Using this knowledge could decrease overtreatment and make prevention of diabetes far more efficient , effective , and patient centered , provided that decision making is based on an accurate risk prediction tool .


Our objective was to evaluate the efficacy and safety of Batroxobin on blood loss during spinal operations .


After obtaining approval from the ethics committee at the hospital along with informed written consent , we performed a double-blind , randomized , placebo-controlled study with 100 patients who were randomized equally into 2 groups ( Batroxobin and placebo ) .


Patients received either 2 ku IV 15 min before surgery and followed 1 ku IM of Batroxobin following surgery , or an equivalent volume of placebo ( normal saline ) .


Cost of Batroxobin treatment is amounted to 84.75 euros .


The primary outcomes were intraoperative , 24 h postoperative , and total perioperative blood loss .


Secondary outcomes were hemoglobin ( Hb ) , red blood cell count ( RBC ) , the volume of blood/fluid transfusion intraoperatively , and 24 h postoperatively .


Safety evaluation parameters were the incidence of venous thrombosis in the lower extremities , active partial thromboplastin time , prothrombin time , thrombin time , and fibrinogen .


The data were analyzed using the Statistical Package for the Social Science Version 12.0 .


The results were presented as mean SEM .


The Mann-Whitney test and Independent Student t test , when appropriate , were used to compare the 2 groups , and differences were considered significant if the P value was < 0.05 .


88 patients were included in the analysis while 12 patients were withdrawn from the study due to extended surgical duration , change of surgical procedure , or after the patients ' request .


The total perioperative blood loss was approximately 31 % lower in patients given Batroxobin versus placebo ( 700.5 45.81 vs 485.7 30.01 mL , P = 0.001 ) .


The Batroxobin group had significantly less intraoperative blood loss ( 326.1 24.16 ) compared to the placebo group ( 556.0 43.58 ) , but there was no difference in the amount of blood/fluid transfused , postoperatively Hb , or RBC between the two groups .


After the operation , coagulation parameters were not significantly different between the 2 groups at the days 1 or 3 postoperatively .


No adverse events related to the use of Batroxobin were recorded .


There were no cases of superficial wound infection .


None of the subjects died during the study .


In this study , prophylactic use of Batroxobin provided an effective and cheap method for reducing blood loss without coagulopathy during or after operations .


The use of Batroxobin for patients undergoing one-level PLIF surgery safely and effectively reduced the total amount of perioperative blood loss .


Physical activity during chemotherapy has been shown in several studies to reduce fatigue , improve symptoms and impact positively on health-related quality of life ( HRQoL ) .


Challenges associated with intervention studies on physical activity during cancer treatment relate to consistent adherence .


The primary objective was to study feasibility and adherence of physical activity intervention among patients with cancer during adjuvant chemotherapy treatment .


The secondary objective was to investigate the effects of physical activity on health aspects , including HRQoL , symptoms and surrogate markers for cardiovascular disease .


This randomized controlled trial included patients with breast cancer ( BRCA ) and colorectal cancer ( CRC ) during adjuvant chemotherapy .


The intervention continued for 10 weeks and included daily walks of 10 000 steps and a weekly supervised group walk .


Adherence was assessed by a pedometer and the number of participants who reported step counts every week and percentage of participants who achieved the target steps every week .


Adherence average reached 91 % during the intervention period ; in total 74 % completed the exercise intervention .


The majority of the participants achieved an average of 83 % of the target of 10 000 steps per day for 10 weeks .


There was a significant increase in daily physical activity ( p = 0.016 ) in the intervention group .


Significant differences were also found for some breast cancer-specific symptoms [ swelling , mobility and pain ( p = 0.045 ) ] .


The study showed a relatively small weight gain an average of 0.9 kg in the intervention group and 1.3 kg in the control group .


Physical activity in the form of walking is feasible during adjuvant chemotherapy treatment despite increasing symptoms .


The physical activity increased in the intervention group during the study time and had a positive impact on breast symptoms and the weight gain was lower in comparison to previous studies .


The metabolism of alcohol and cognitive functions can vary during the menstrual cycle .


Also , both alcohol ingestion and hormonal variations during menstruation have been associated with characteristic changes in electroencephalographic ( EEG ) activity .


AIM .


To determine whether EEG activity during a working memory task is affected by acute alcohol consumption , and if these EEG patterns vary in relation to different phases of the menstrual cycle .


24 women who drank a moderate dose of alcohol or placebo during the follicular and early luteal phases of the menstrual cycle .


The EEG activity was recorded during performance of viso-spatial working memory task .


Although the alcohol did not deteriorate the performance of working memory task , it caused in the EEG a decrease of relative theta power and lower right fronto-parietal correlation in theta and alpha2 bands .


Only women who drank alcohol in the follicular phase had a higher relative potency of alpha1 , which could indicate a lower level of arousal and attention .


These results contribute to a better understanding of the brain mechanisms underlying cognitive changes with alcohol and its relationship to the menstrual cycle .


A low glycemic index ( GI ) diet is beneficial for glucose control in patients with diabetes mellitus .


This study aimed to investigate the influence of a low-GI diet on postprandial glucose levels in women with gestational diabetes mellitus ( GDM ) .


Pregnant women with GDM were randomized to receive a normal diabetic control diet or a low-GI staple diet for 5 days .


A low-GI staple food was used to replace rice in lunch and dinner for the low-GI staple diet group , whereas the total energy and carbohydrate levels remained equal in both groups .


Fasting and postprandial glucose levels were determined daily .


A total of 140 pregnant women with GDM were included in the study , including 66 in the low-GI staple diet group and 74 in the normal diabetic diet control group .


No differences existed in baseline characteristics between the 2 groups ( all P > 0.05 ) .


After dietary intervention , glucose levels were significantly reduced in the low-GI staple diet group ( all P < 0.01 ) and the control group ( all P < 0.008 ) .


Postintervention glucose values after breakfast , lunch , and dinner were significantly reduced in the treatment group compared with those in the control group ( all P < 0.05 ) .


The percentage changes from baseline of all glucose values were significantly greater in the treatment group than in the control group ( all P < 0.05 ) .


A low-GI staple diet significantly reduces postprandial glucose levels in women with GDM .


The relationship between the risk of celiac disease and both the age at which gluten is introduced to a child 's diet and a child 's early dietary pattern is unclear .


We randomly assigned 832 newborns who had a first-degree relative with celiac disease to the introduction of dietary gluten at 6 months ( group A ) or 12 months ( group B ) .


The HLA genotype was determined at 15 months of age , and serologic screening for celiac disease was evaluated at 15 , 24 , and 36 months and at 5 , 8 , and 10 years .


Patients with positive serologic findings underwent intestinal biopsies .


The primary outcome was the prevalence of celiac disease autoimmunity and of overt celiac disease among the children at 5 years of age .


Of the 707 participants who remained in the trial at 36 months , 553 had a standard-risk or high-risk HLA genotype and completed the study .


At 2 years of age , significantly higher proportions of children in group A than in group B had celiac disease autoimmunity ( 16 % vs. 7 % , P = 0.002 ) and overt celiac disease ( 12 % vs. 5 % , P = 0.01 ) .


At 5 years of age , the between-group differences were no longer significant for autoimmunity ( 21 % in group A and 20 % in group B , P = 0.59 ) or overt disease ( 16 % and 16 % , P = 0.78 by the log-rank test ) .


At 10 years , the risk of celiac disease autoimmunity was far higher among children with high-risk HLA than among those with standard-risk HLA ( 38 % vs. 19 % , P = 0.001 ) , as was the risk of overt celiac disease ( 26 % vs. 16 % , P = 0.05 ) .


Other variables , including breast-feeding , were not associated with the development of celiac disease .


Neither the delayed introduction of gluten nor breast-feeding modified the risk of celiac disease among at-risk infants , although the later introduction of gluten was associated with a delayed onset of disease .


A high-risk HLA genotype was an important predictor of disease .


( Funded by the Fondazione Celiachia of the Italian Society for Celiac Disease ; CELIPREV ClinicalTrials.gov number , NCT00639444 . )


Cardiovascular disease ( CVD ) is the leading cause of early death worldwide , responsible for an estimated 29 % of all global deaths .


Reducing salt intake lowers blood pressure and risk of secondary cardiac events .


However , identifying low salt foods can be challenging .


SaltSwitch is a simple smartphone application ( app ) that enables shoppers to scan the barcode of packaged foods and receive an immediate , interpretive , traffic light nutrition label on the screen , along with suggestions for healthier lower-salt alternatives .


A growing body of evidence suggests mobile technologies can support healthy behaviour change .


However , robust evidence for the impact of smartphone interventions is lacking .


This manuscript outlines the rationale and methods for a randomized controlled trial designed to determine the effectiveness of SaltSwitch in supporting people with CVD to make lower-salt food choices .


A 6-week , two-arm , parallel , randomized controlled trial is being undertaken in New Zealand ( 2weeks baseline and 4weeks intervention ) .


Three hundred adults aged 40years and older with CVD and their main household shoppers are recruited from research lists , cardiac rehabilitation clinics , and communities in Auckland .


Participants are randomized to receive either the SaltSwitch smartphone app or no intervention ( control ) .


Randomisation is stratified by ethnicity and age .


The primary outcome is the salt content of household food purchases .


Secondary outcomes are the saturated fat and energy content of household food purchases , household food expenditure , use and acceptability of the SaltSwitch app by shoppers , and urinary sodium and blood pressure of participants with CVD .


Ambulatory blood pressure and potential longer-term impact ( 12weeks ) of SaltSwitch will be assessed in sub-studies ( n ~ 40 and n ~ 20 , respectively ) .


Household purchases of salt and other nutrients will be assessed using till receipt data electronically linked with branded food composition data .


The results of the SaltSwitch trial will determine the effectiveness , use and acceptability of a smartphone application to support lower salt food choices and secondary prevention of CVD .


ACTRN12614000206628 .


Registered 30 March 2014 .


Prognostic models , such as the Seattle Heart Failure Model ( SHFM ) , have been developed to predict patient survival .


The extent to which they predict medical resource use and costs has not been explored .


In this study , we evaluated relationships between baseline SHFM scores and 1-year resource use and costs using data from a clinical trial .


We applied generalized linear models to examine the relative impact of a 1-unit increase in SHFM scores on counts of medical resource use and direct medical costs at 1 year of follow-up .


Of 2331 randomized patients , 2288 ( 98 % ) had a rounded integer SHFM score between -1 and 2 , consistent with predicted 1-year survival of 98 % and 74 % , respectively .


At baseline , median age was 59 years , 28 % of patients were women , and nearly two-thirds of the cohort had New York Heart Association class II heart failure and one-third had class III heart failure .


Higher SHFM scores were associated with more hospitalizations ( rate ratio per 1-unit increase , 1.86 ; P < .001 ) , more inpatient days ( 2.30 ; P < .001 ) , and higher inpatient costs ( 2.28 ; P < .001 ) , outpatient costs ( 1.54 ; P < .001 ) , and total medical costs ( 2.13 ; P < .001 ) .


Although developed to predict all-cause mortality , SHFM scores also predict medical resource use and costs .


Obesity-attributable medical expenditures remain high , and interventions that are both effective and cost-effective have not been adequately developed .


The Opt-IN study is a theory-guided trial using the Multiphase Optimization Strategy ( MOST ) to develop an optimized , scalable version of a technology-supported weight loss intervention .


Opt-IN aims to identify which of 5 treatment components or component levels contribute most meaningfully and cost-efficiently to the improvement of weight loss over a 6 month period .


Five hundred and sixty obese adults ( BMI 30-40 kg/m ( 2 ) ) between 18 and 60 years old will be randomized to one of 16 conditions in a fractional factorial design involving five intervention components : treatment intensity ( 12 vs. 24 coaching calls ) , reports sent to primary care physician ( No vs. Yes ) , text messaging ( No vs. Yes ) , meal replacement recommendations ( No vs. Yes ) , and training of a participant 's self-selected support buddy ( No vs. Yes ) .


During the 6-month intervention , participants will monitor weight , diet , and physical activity on the Opt-IN smartphone application downloaded to their personal phone .


Weight will be assessed at baseline , 3 , and 6 months .


The Opt-IN trial is the first study to use the MOST framework to develop a weight loss treatment that will be optimized to yield the best weight loss outcome attainable for $ 500 or less .


To compare the morphological ( cell density , coefficient of variation and standard deviation ) and functional ( central corneal thickness ) endothelial changes after phacoemulsification versus manual small-incision cataract surgery ( MSICS ) .


Prospective randomized control study .


In this prospective randomized control study , patients were randomly allocated to undergo phacoemulsification ( Group 1 , n = 100 ) or MSICS ( Group 2 , n = 100 ) using a random number Table .


The patients underwent complete ophthalmic evaluation and specular microscopy preoperatively and at 1and 6 weeks postoperatively .


Functional and morphological endothelial evaluation was Noncon ROBO PACHY SP-9000 specular microscope .


Phacoemulsification was performed , the chop technique and MSICS , by the viscoexpression technique .


The mean difference in central corneal thickness at baseline and 1 week between Group 1 and Group 2 was statistically significant ( P = 0.027 ) .


However , this difference at baseline when compared to 6 week and 1 week , 6 weeks was not statistically significant ( P > 0.05 ) .


The difference in mean endothelial cell density between groups at 1 week and 6 weeks was statistically significant ( P = 0.016 ) .


The mean coefficient of variation and mean standard deviation between groups were not statistically significant ( P > 0.05 , both comparisons ) .


The central corneal thickness , coefficient of variation , and standard deviation were maintained in both groups indicating that the function and morphology of endothelial cells was not affected despite an initial reduction in endothelial cell number in MSICS .


Thus , MSICS remains a safe option in the developing world .


Fatigue affects more than 60 % of multiple sclerosis ( MS ) patients and is one of the most troublesome symptoms of the disease .


Current treatment options for MS fatigue include amantadine , modafinil and acetyl-l-carnitine ( ALCAR ) .


The aim of our study was to compare efficacy of amantadine , modafinil and ALCAR with placebo in patients with MS.


Patients with MS and a disability level 5.5 on the Kurtzke Expanded Disability Status Scale ( EDSS ) and fatigue were included in the study .


Patients were assigned to a one month treatment with either amantadine 200mg , ALCAR 2g , modafinil 200mg or placebo .


Efficacy of the treatment was evaluated by using the modified fatigue impact scale ( MFIS ) .


Sixty patients were included in the study ( 39 females ) .


The mean age of patients was 38 6.7 years and the mean disease duration was 6.6 1.2 years .


Contrast analysis showed significantly lower mean MFIS score after one month in patients on amantadine compared to placebo ( mean difference = 17.3 , p = 0.001 ) .


There was also a trend of a lower MFIS score in ALCAR group in comparison to placebo ( mean difference = 12.4 , p = 0.05 , with Keppel-corrected alpha of 0.046 ) .


The quality of life measured as SF 36 - PCS and SF 36 - MCS proved to be significantly influenced by treatment .


One month treatment with amantadine improved fatigue in patients with relapsing-remitting MS as evaluated by MFIS .


No or only a trend of improvement was seen in patients treated with modafinil or ALCAR , respectively .


To evaluate whether 5-mm short dental implants could be an alternative to augmentation with anorganic bovine bone and placement of at least 10-mm long implants in posterior atrophic jaws .


Fifteen patients with bilateral atrophic mandibles ( 5 mm to 7 mm bone height above the mandibular canal ) and 15 patients with bilateral atrophic maxillae ( 4 mm to 6 mm bone height below the maxillary sinus ) , and bone thickness of at least 8 mm , were randomised according to a split-mouth design to receive one to three 5-mm short implants or at least 10-mm long implants in augmented bone .


Mandibles were vertically augmented with interpositional bone blocks and maxillary sinuses with particulated bone via a lateral window .


Implants were placed after 4 months , submerged and loaded , after another 4 months , with provisional prostheses .


Four months later , definitive provisionally cemented prostheses were delivered .


Outcome measures were : prosthesis and implant failures ; any complication and peri-implant marginal bone level changes .


In five augmented mandibles , the planned 10-mm long implants could not be placed and shorter implants ( 7 mm and 8.5 mm ) had to be used instead .


Three years after loading , two patients , one treated in the mandible and one in the maxilla , dropped out .


Three prostheses ( 1 mandibular and 2 maxillary ) failed in the short implant group versus none in the long implant group .


In mandibles , one long implant failed versus two short implants in 1 patient .


In maxillae , one long implant failed versus three short implants in 2 patients .


There were no statistically significant differences in the failures .


Eight patients had 13 complications at short implants ( 1 patient accounted for 6 complications ) and 11 patients had 13 complications at long implants .


There were no statistically significant differences in complications ( P = 0.63 , difference = 0.10 , 95 % CI from -0.22 to 0.42 ) .


Three years after loading , patients with mandibular implants lost on average 1.44 mm at short implants and 1.63 mm at long implants of peri-implant marginal bone .


This difference was not statistically significant ( difference = 0.24 mm ; 95 % CI -0.01 , 0.49 P = 0.059 ) .


In maxillae , patients lost on average 1.02 mm at short implants and 1.54 mm at long implants .


This difference was statistically significant ( difference = 0.41 mm ; 95 % CI 0.21 , 0.60 , P = 0.001 ) .


Three years after loading , 5-mm short implants achieved similar results as longer implants in augmented bone .


Short implants might be a preferable choice to vertical bone augmentation , especially in mandibles , since the treatment is faster and cheaper , however there are still insufficient data on the long-term prognosis of short implants .


To examine the efficacy and safety of canagliflozin monotherapy , a sodium/glucose co-transporter 2 inhibitor , in Japanese type 2 diabetes patients .


In this double-blind , multi-centre Phase III study , patients aged 20 years with hemoglobin A1c ( HbA1c ) 7.0-10 .0 % on diet/exercise therapy alone received placebo or canagliflozin ( 100 or 200 mg ) once daily for 24 weeks .


The main outcome measure was the change in HbA1c from baseline to Week 24 .


The changes in HbA1c ( -0.74 and -0.76 vs + 0.29 % ) , fasting plasma glucose ( 1 mg/dl = 0.0555 mmol/l ; -31.6 and -31.9 vs + 3.7 mg/dl ) , 2-h plasma glucose after 75-g glucose load ( -84.9 and -79.0 vs -0.5 mg/dl ) , body weight ( percent change : -3.76 and -4.02 vs -0.76 % ) and systolic blood pressure ( -7.88 and -6.24 vs -2.72 mmHg ) were significantly greater with 100 and 200 mg canagliflozin than with placebo ( all , p < 0.05 ) .


Genital infections in females ( 6.5 , 6.3 and 0 % ) and asymptomatic hypoglycemia ( 4.4 , 5.6 and 2.2 % ) , but not symptomatic hypoglycemia ( 2.2 , 1.1 and 1.1 % ) , were more frequent in the 100 - and 200-mg groups than in the placebo group .


Canagliflozin significantly improved glycemic control and was well tolerated .


To evaluate the efficacy of a marketed stabilized stannous fluoride ( SnF2 ) dentifrice in reducing dentinal hypersensitivity as compared to a marketed sodium fluoride ( NaF ) / triclosan dentifrice over an eight-week period .


Adults with confirmed dentinal hypersensitivity were enrolled in this randomized and controlled , parallel group , double blind , eight-week , single-center clinical trial .


Random assignment to one of two dentifrice test groups via age , gender , and thermal sensitivity of enrolled test teeth was performed at baseline , with subjects assigned to twice-daily unsupervised brushing with either the marketed SnF2 dentifrice ( Oral-B Pro-Expert , 0.454 % SnF2 plus 0.077 % NaF ) or the marketed 0.32 % NaF with 0.3 % triclosan/copolymer dentifrice control ( Colgate Total Advanced ) .


Tactile sensitivity ( Yeaple Probe ) and thermal sensitivity ( airblast/Schiff Air Index ) evaluations of the selected test teeth were performed at baseline pre-treatment , and again at Weeks 2 and 8 of product use to compare the dentifrices ' relative hypersensitivity protection effectiveness .


Ninety-seven ( 97 ) of the 100 enrolled subjects completed the trial and were fully evaluable .


At both Week 2 and Week 8 , for both the thermal and tactile evaluation measurements , subjects brushing with the marketed SnF2 dentifrice experienced statistically significantly ( p < 0.0001 ) superior average dentinal hypersensitivity improvement versus subjects assigned to the NaF/triclosan control dentifrice .


Between groups , superior relative mean reduction in thermal Schiff Air Index favored SnF2 by 24 % at Week 2 and 68 % at Week 8 , while greater relative mean tactile Yeaple Probe benefits were observed for SnF2 relative to the control by 114 % after Week 2 and 184 % at Week 8 .


The dentifrices were well-tolerated .


Twice-daily brushing with a marketed SnF2 dentifrice provided superior dentinal hypersensitivity improvement versus a commercially available NaF/triclosan dentifrice , with significantly ( p < 0.0001 ) greater relief after two weeks , and even larger relative benefits at eight weeks .


Pediatric-onset Crohn disease is more aggressive than adult-onset disease , has high rates of resistance to existing drugs , and can lead to permanent impairments .


Few trials have evaluated new drugs for refractory Crohn disease in children .


To determine whether thalidomide is effective in inducing remission in refractory pediatric Crohn disease .


Multicenter , double-blind , placebo-controlled , randomized clinical trial of 56 children with active Crohn disease despite immunosuppressive treatment , conducted August 2008-September 2012 in 6 pediatric tertiary care centers in Italy .


Thalidomide , 1.5 to 2.5 mg/kg per day , or placebo once daily for 8 weeks .


In an open-label extension , nonresponders to placebo received thalidomide for an additional 8 weeks .


All responders continued to receive thalidomide for an additional minimum 52 weeks .


Primary outcomes were clinical remission at week 8 , measured by Pediatric Crohn Disease Activity Index ( PCDAI ) score and reduction in PCDAI by 25 % or 75 % at weeks 4 and 8 .


Primary outcomes during the open-label follow-up were clinical remission and 75 % response .


Twenty-eight children were randomized to thalidomide and 26 to placebo .


Clinical remission was achieved by significantly more children treated with thalidomide ( 13/28 [ 46.4 % ] vs 3/26 [ 11.5 % ] ; risk ratio [ RR ] , 4.0 [ 95 % CI , 1.2-12 .5 ] ; P = .01 ; number needed to treat [ NNT ] , 2.86 ) .


Responses were not different at 4 weeks , but greater improvement was observed at 8 weeks in the thalidomide group ( 75 % response , 13/28 [ 46.4 % ] vs 3/26 [ 11.5 % ] ; RR , 4.0 [ 95 % CI , 1.2-12 .5 ] ; NNT = 2.86 ; P = .01 ; and 25 % response , 18/28 [ 64.2 % ] vs 8/26 [ 30.8 % ] ; RR , 2.1 [ 95 % CI , 1.1-3 .9 ] ; NNT = 2.99 ; P = .01 ) .


Of the nonresponders to placebo who began receiving thalidomide , 11 of 21 ( 52.4 % ) subsequently reached remission at week 8 ( RR , 4.5 [ 95 % CI , 1.4-14 .1 ] ; NNT = 2.45 ; P = .01 ) .


Overall , 31 of 49 children treated with thalidomide ( 63.3 % ) achieved clinical remission , and 32 of 49 ( 65.3 % ) achieved 75 % response .


Mean duration of clinical remission in the thalidomide group was 181.1 weeks ( 95 % CI , 144.53-217 .76 ) vs 6.3 weeks ( 95 % CI , 3.51-9 .15 ) in the placebo group ( P < .001 ) .


Cumulative incidence of severe adverse events was 2.1 per 1000 patient-weeks , with peripheral neuropathy the most frequent severe adverse event .


In children and adolescents with refractory Crohn disease , thalidomide compared with placebo resulted in improved clinical remission at 8 weeks of treatment and longer-term maintenance of remission in an open-label follow-up .


These findings require replication to definitively determine clinical utility of this treatment .


clinicaltrials.gov Identifier : NCT00720538 .


The effects of electronic health records ( EHRs ) on doctor-patient communication are unclear .


To evaluate the effects of EHR use compared with paper chart use , on novice physicians ' communication skills .


Within-subjects randomized controlled trial using observed structured clinical examination methods to assess the impact of use of an EHR on communication .


A large academic internal medicine training program .


First-year internal medicine residents .


Residents interviewed , diagnosed , and initiated treatment of simulated patients using a paper chart or an EHR on a laptop computer .


Video recordings of interviews were rated by three trained observers using the Four Habits scale .


Thirty-two residents completed the study and had data available for review ( 61.5 % of those enrolled in the residency program ) .


In most skill areas in the Four Habits model , residents performed at least as well using the EHR and were statistically better in six of 23 skills areas ( p < 0.05 ) .


The overall average communication score was better when using an EHR : mean difference 0.254 ( 95 % CI 0.05 to 0.45 ) , p = 0.012 , Cohen 's d of 0.47 ( a moderate effect ) .


Residents scoring poorly ( > 3 average score ) with paper methods ( n = 8 ) had clinically important improvement when using the EHR .


This study was conducted in first-year residents in a training environment using simulated patients at a single institution .


Use of an EHR on a laptop computer appears to improve the ability of first-year residents to communicate with patients relative to using a paper chart .


There is abundant research indicating poor physical , psychological , and social functioning of patients with chronic heart failure ( HF ) , a reality that can lead to poor health-related quality of life ( QoL ) .


Little is known about the experience of rural patients with HF .


This study was part of a randomized clinical trial titled Rural Education to Improve Outcomes in Heart Failure ( REMOTE-HF ) designed to test an education and counseling intervention to improve self-care in patients with HF .


We evaluated 612 rural patients .


Multiple validated questionnaires were administered to assess patient perceptions of health and health literacy .


Baseline factors were collected and compared with baseline QoL measures only .


Patients ' health-related QoL was assessed using the Minnesota Living with Heart Failure scale .


The data were analyzed using a general linear model to test the association of various patient characteristics with QoL in rural patients with HF .


Patients were 65.8 ( +12.9 ) years of age .


The majority were men ( 58.7 % ) , married ( 56.4 % ) , and had completed a high-school education ( 80.9 % ) .


Factors associated with reduced QoL among this population include geographic location , younger age , male sex , higher New York Heart Association class , worse HF knowledge , poorer perceived control , and symptoms of depression or anxiety .


The data provided no evidence of an association between left ventricular ejection fraction and QoL .


This study of rural patients with HF confirms previously identified factors associated with perceptions of QoL .


However , further study is warranted with an urban control group .


http://www.clinicaltrials.gov .


Unique identifier : NCT00415545 .


Eprotirome is a liver-selective thyroid hormone receptor agonist that has been shown to lower plasma LDL cholesterol concentrations in previous phase 1 and 2 studies of patients with dyslipidaemia .


We aimed to assess the long-term safety and efficacy of 50 g and 100 g eprotirome in patients with familial hypercholesterolaemia .


For this randomised , double-blind , placebo-controlled , parallel-group , phase 3 clinical trial , we enrolled patients between Oct 3 , 2011 , and Feb 14 , 2012 , at 53 sites in 11 countries in Europe , Africa , and south Asia .


Patients were eligible for enrolment if they were aged 18 years or older , diagnosed with heterozygous familial hypercholesterolaemia , and had not reached target LDL cholesterol concentrations after at least 8 weeks of statin therapy with or without ezetimibe .


We used a computer-generated randomisation sequence to allocate patients to one of three groups : 50 g eprotirome , 100 g eprotirome , or placebo .


This trial was planned for 52-76 weeks , with primary efficacy analysis at 12 weeks , but it was prematurely terminated when another study found that eprotirome causes cartilage damage in dogs .


Although it was impossible to meet the predefined study outcomes , we analysed changes in the concentrations of LDL cholesterol and other lipids , liver parameters , thyroid hormone concentrations , and adverse effects of treatment with eprotirome versus placebo at 6 weeks of treatment .


Analysis was done in all patients who received 6 weeks of treatment .


This study is registered with ClinicalTrials.gov , number NCT01410383 .


We enrolled 236 patients , randomly allocating 80 to receive placebo , 79 to receive 50 g eprotirome , and 77 to receive 100 g eprotirome .


69 patients reached the 6 week timepoint ( 23 given placebo , 24 given 50 g eprotirome , and 22 given 100 g eprotirome ) .


Mean LDL cholesterol concentrations increased by 9 % ( 95 % CI -2 to 20 ) in the placebo group , decreased by 12 % ( -28 to 4 % ; p = 0.0677 vs placebo ) in the 50 g eprotirome group , and decreased by 22 % ( -32 to -13 % ; p = 0.0045 vs placebo ) in the 100 g eprotirome group .


We noted statistically significant increases between both eprotirome groups and placebo in aspartate aminotransferase ( AST ; p < 0.0001 ) , alanine aminotransferase ( ALT ; p < 0.0001 ) , conjugated bilirubin ( p = 0.0006 ) , and gamma-glutamyltranspeptidase ( p < 0.0001 ) .


Four patients had to discontinue or interrupt study treatment before trial termination due to AST increases between the upper limit of normal ( ULN ) and six times ULN , and ALT concentrations between three and seven times ULN .


Although we detected no changes in serum concentrations of thyroid-stimulating hormone or free tri-iodothyronine , free tetra-iodothyronine decreased by 19 % ( 23 to 16 ) in the 50 g eprotirome group and 27 % ( 30 to 23 ) in the 100 g eprotirome group ( p < 0.0001 vs placebo for both groups ) .


Our findings show that eprotirome can lower LDL cholesterol concentrations in patients with familial hypercholesterolaemia when added to conventional statin treatment with or without ezetimibe , but that it has the potential to induce liver injury .


These findings , along with findings of cartilage damage in dogs , raise serious doubts about selective thyroid hormone mimetics as a therapeutic approach to lower LDL cholesterol concentrations .


Karo Bio AB .


The aim of the present study was to compare the pharmacokinetic profiles between a new generic and a branded reference formulation of irbesartan / hydrochlorothiazide FDC tablets , and to assess the bioequivalence of the two products in healthy Chinese male volunteers .


24 male healthy volunteers participated in the open-label , single-dose , randomized-sequence , 2-way crossover study .


Eligible subjects were randomly assigned ( 1:1 ) to receive a single 300/12 .5 - mg dose of either the test or reference formulation followed by a 1-week washout .


Blood samples were obtained before ( 0 hours ) and 0.5 , 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 24 , 36 , 48 , and 72 hours after dosing .


Plasma concentrations of irbesartan and hydrochlorothiazide were analyzed by two separate validated liquid chromatography/tandem mass spectrometric ( LC-MS/MS ) methods .


For irbesartan , the 90 % confidence intervals ( CIs ) of AUC0-t , AUC0 - , and Cmax were 103.27-116 .71 % , 105.01-121 .47 % , and 84.15-96 .88 % , respectively .


For hydrochlorothiazide , the 90 % CIs of AUC0-t , AUC0 - , and Cmax were 96.11-109 .02 % , 95.15-107 .35 % , and 91.66-101 .40 % , respectively .


A total of 3 mild AEs were reported in 3 subjects ( 12.5 % ) .


In this study , a single dose ( 300/12 .5 - mg ) of the test formulation of irbesartan and hydrochlorothiazide FDC tablet in fasting healthy Chinese male volunteers met WHO 's and China 's FDA regulatory criteria for assumption of bioequivalence to the reference formulation based on AUC and Cmax .


Both formulations were well tolerated .


Both HIV infection and antiretroviral therapy ( ART ) may increase cardiovascular disease ( CVD ) risk .


Assessments of vascular function and structure can be used to study the pathogenesis and progression of CVD , including the effects of ART and other interventions .


The objective of this report is to understand methods to assess vascular ( dys ) function and report our experience in the Arterial Elasticity Substudy in the Strategic Timing of AntiRetroviral Treatment ( START ) trial .


We review literature and analyze baseline data from the Arterial Elasticity Substudy , which estimated vascular ( dys ) function through analysis of the diastolic blood pressure ( BP ) waveform .


Linear regression was used to study cross-sectional associations between baseline clinical factors and small or large arterial elasticity .


Arterial elasticity measurement was chosen for its improved measurement reproducibility over other methodologies and the potential of small arterial elasticity to predict clinical risk .


Analysis of baseline data demonstrates that small artery elasticity is impaired ( lower ) with older age and differs by race and between geographical regions .


No HIV-specific factors studied remained significantly associated with arterial elasticity in multivariate models .


Longitudinal analyses in this substudy will provide essential randomized data with which to study the effects of early ART initiation on the progression of vascular disease among a diverse global population .


When combined with future biomarker analyses and clinical outcomes in START , these findings will expand our understanding of the pathogenesis of HIV-related CVD .


To determine whether impaired awareness of hypoglycemia ( IAH ) can be improved and severe hypoglycemia ( SH ) prevented in type 1 diabetes , we compared an insulin pump ( continuous subcutaneous insulin infusion [ CSII ] ) with multiple daily injections ( MDIs ) and adjuvant real-time continuous glucose monitoring ( RT ) with conventional self-monitoring of blood glucose ( SMBG ) .


A 24-week 2 2 factorial randomized controlled trial in adults with type 1 diabetes and IAH was conducted .


All received comparable education , support , and congruent therapeutic targets aimed at rigorous avoidance of biochemical hypoglycemia without relaxing overall control .


Primary end point was between-intervention difference in 24-week hypoglycemia awareness ( Gold score ) .


A total of 96 participants ( mean diabetes duration 29 years ) were randomized .


Overall , biochemical hypoglycemia ( 3.0 mmol/L ) decreased ( 53 63 to 24 56 min/24 h ; P = 0.004 [ t test ] ) without deterioration in HbA1c .


Hypoglycemia awareness improved ( 5.1 1.1 to 4.1 1.6 ; P = 0.0001 [ t test ] ) with decreased SH ( 8.9 13.4 to 0.8 1.8 episodes/patient-year ; P = 0.0001 [ t test ] ) .


At 24 weeks , there was no significant difference in awareness comparing CSII with MDI ( 4.1 1.6 vs. 4.2 1.7 ; difference 0.1 ; 95 % CI -0.6 to 0.8 ) and RT with SMBG ( 4.3 1.6 vs. 4.0 1.7 ; difference -0.3 ; 95 % CI -1.0 to 0.4 ) .


Between-group analyses demonstrated comparable reductions in SH , fear of hypoglycemia , and insulin doses with equivalent HbA1c .


Treatment satisfaction was higher with CSII than MDI ( 32 3 vs. 29 6 ; P = 0.0003 [ t test ] ) , but comparable with SMBG and RT ( 30 5 vs. 30 5 ; P = 0.79 [ t test ] ) .


Hypoglycemia awareness can be improved and recurrent SH prevented in long-standing type 1 diabetes without relaxing HbA1c .


Similar biomedical outcomes can be attained with conventional MDI and SMBG regimens compared with CSII/RT , although satisfaction was higher with CSII .


Cold hands sensation is a common disorder within the Korean population .


Many Korean family physicians believe that it is a mild early manifestation of Raynaud 's phenomenon ( RP ) , or may be related to RP .


RP is characterized by reversible digital vasospasm provoked by cold temperatures and/or emotional stress , and doctors often prescribe medications that are used in treatment of RP for subjects with cold hands .


However , this has not shown a clear benefit , and these medications can cause unwanted side effects .


It is also reported that traditional Korean medicine , including acupuncture , is widely used to treat cold hands , although the current level of evidence for this approach is also poor and to date , there have been no published randomized controlled clinical trials ( RCTs ) evaluating the efficacy and safety of acupuncture for cold hands .


We have therefore designed a pilot RCT to obtain information for the design of a further full-scale trial .


The proposed study is a five-week pilot RCT .


A total of 14 subjects will be recruited and randomly allocated to two groups : an acupuncture plus medication group ( experimental group ) and a medication-only group ( control group ) .


All subjects will take nifedipine ( 5 mg once daily ) and beraprost ( 20 mg three times daily ) for three weeks .


The experimental group will receive additional treatment with three acupuncture sessions per week for three weeks ( nine sessions total ) .


The primary outcome will be measured using a visual analogue scale .


Secondary outcomes will be measured by blood perfusion in laser Doppler perfusion imaging of the hands , frequency and duration of episodes of cold hands , and heart rate variability .


Assessments will be made at baseline and at one , three , and five weeks thereafter .


This study will provide an indication of the feasibility and a clinical foundation for a future large-scale trial .


This study was registered at Korean Clinical Research Information Service ( CRIS ) registry on 5 August 2013 with the registration number #KCT 0000817 .


Elevating the hospital head of bed ( HOB ) to at least 30 is recommended practice to reduce the risk of ventilator-associated pneumonia ( VAP ) in mechanically ventilated patients .


However , this common practice prescribes the position of the bed and not of the patient , which could be significantly different .


The aim of this research was to determine the relationship between patient migration in bed and anatomic torso angle .


Ten healthy participants were positioned in a hospital bed that was raised from flat to 30 and 45 HOB elevations .


Prior to bed movement , participants were aligned to different locations along the length of the bed to represent different amounts of migration .


A motion capture system was used to measure torso angle and migration toward the foot of the bed .


The relationship between torso angle and migration was estimated by linear regression .


Patient migration resulted in lower torso angles for both 30 and 45 HOB articulations .


A migration of 10 cm resulted in a loss of 9.1 and 13.0 of torso angle for HOB articulations of 30 and 45 , respectively ( for 30 articulations : ( Equation is included in full-text article . )


= -0.91 , R = .96 ; for 45 articulations : ( Equation is included in full-text article . )


= -1.30 , R = .98 ) .


Migration toward the foot of the bed flattens the torso .


To maintain a torso angle that is likely to protect against VAP , healthcare providers need to manage both HOB angle and migration .


Protocols and equipment that minimize patient migration will help support effective clinical practice .


Future research on patient migration , as it relates to VAP or other outcomes , should measure patient torso angle to allow accurate translation of the results to care practice .


This two-stage phase IB study investigated the pharmacokinetics and safety of subcutaneous ( SC ) versus intravenous ( IV ) administration of rituximab as maintenance therapy in follicular lymphoma .


In stage 1 ( dose finding ) , 124 patients who responded to rituximab induction were randomly assigned to SC rituximab ( 375 mg/m2 , 625 mg/m2 , or an additional group at 800 mg/m2 ) or IV rituximab ( 375 mg/m2 ) .


The objective was to determine an SC dose that would yield a rituximab serum trough concentration ( Ctrough ) in the same range as that of IV rituximab .


In stage 2 , 154 additional patients were randomly assigned ( 1:1 ) to SC rituximab ( 1,400 mg ) or IV rituximab ( 375 mg/m2 ) given at 2 - or 3-month intervals .


The objective was to demonstrate noninferior rituximab Ctrough of SC rituximab relative to IV rituximab 375 mg/m2 .


Stage 1 data predicted that a fixed dose of 1,400 mg SC rituximab would result in a serum Ctrough in the range of that of IV rituximab .


Noninferiority ( ie , meeting the prespecified 90 % CI lower limit of 0.8 ) was then confirmed in stage 2 , with geometric mean Ctrough SC : Ctrough IV ratios for the 2 - and 3-month regimens of 1.24 ( 90 % CI , 1.02 to 1.51 ) and 1.12 ( 90 % CI , 0.86 to 1.45 ) , respectively .


Overall safety profiles were similar between formulations ( in stage 2 , 79 % of patients experienced one or more adverse events in each group ) .


Local administration-related reactions ( mainly mild to moderate ) occurred more frequently after SC administration .


The fixed dose of 1,400 mg SC rituximab predicted by using stage 1 results was confirmed to have noninferior Ctrough levels relative to IV rituximab 375 mg/m2 dosing during maintenance , with a comparable safety profile .


Additional investigation will be required to determine whether the SC route of administration for rituximab provides equivalent efficacy compared with that of IV administration .


Myopia is a public health problem worldwide and its incidence increases with age .


The use of acupuncture to treat myopia is a common practice in China , however , the use of acupuncture to treat myopia is disputed in other parts of the world .


This study aims to determine the safety of acupuncture to treat myopia and its efficacy over six months .


A randomized , parallel , single-center , assessor - and statistician-blinded , controlled clinical trial will be performed .


A total of 100 teenagers , between seven and 12 years of age , with mild-to-moderate myopia and spherical lenses < -6.00 D and cylindrical lenses < -1.50 D will be selected from the Xinjiang Uygur Autonomous Region Institute of Traditional Chinese Medicine , a grade III level A teaching hospital in Urumqi , Xinjiang , China ( Xinjiang Medical University Affiliated Hospital of Traditional Medicine ) .


The subjects will be randomly assigned to two different groups ( control and acupuncture groups ) , each group containing 50 subjects .


The subjects in both groups wear single-vision corrective lenses .


In the acupuncture group , acupuncture will be performed daily for nine consecutive days on five points ( bilateral Cuanzhu , Tongziliao , Sibai , Muchuang , and Hegu ) , followed by no treatment for one day .


Six cycles of treatment will be undertaken continuously for a total of 60 days .


Following 60 days of treatment , a follow-up period of six months will be included .


The primary outcome will be diopter determination .


The secondary outcomes will include distance visual acuity , axial length , lens thickness , ciliary body thickness , and subjective symptoms of the eyes and entire body .


The main time points for the evaluation of clinical efficacy will be the first , third , and sixth months after treatment .


This study will provide clinical observations of various indices following the use of acupuncture to treat adolescents with mild-to-moderate myopia , as well as information on the safety of acupuncture .


Chinese Clinical Trial Registry ( identifier : ChiCTR-TRC-13003448 ; registration date : 7 August 2013 ) .


Interleukin-20 ( IL-20 ) is implicated in the pathogenesis of rheumatoid arthritis ( RA ) .


The efficacy , safety , and tolerability of NNC0109-0012 , a selective anti-IL-20 recombinant human monoclonal antibody ( mAb ) , were assessed in patients with active RA who had an inadequate response to methotrexate therapy .


Sixty-seven patients with RA were enrolled and randomized ( 2:1 ) to receive NNC0109-0012 ( 3 mg/kg per week , subcutaneously ) or placebo in a phase IIa , double-blind , 12-week trial with a 13-week followup .


The primary end point was change in the Disease Activity Score in 28 joints based on C-reactive protein level ( DAS28-CRP ) from baseline to week 12 .


In patients treated with NNC0109-0012 , the primary end point , improvement in the DAS28-CRP at week 12 , was achieved ( estimated difference -0.88 ; P = 0.02 ) , with significant improvement starting at week 1 .


A greater response was observed in seropositive patients ( estimated difference -1.66 ; P < 0.001 ) , which was sustained through 13 weeks of followup , whereas no improvement was noted in patients with seronegative RA .


A significant proportion of patients with seropositive RA receiving NNC0109-0012 , compared to those receiving placebo , achieved treatment responses according to the American College of Rheumatology 20 % ( ACR20 ) ( 59 % versus 21 % ) , ACR50 ( 48 % versus 14 % ) , and ACR70 ( 35 % versus 0 % ) levels of improvement , and showed greater improvements in the Health Assessment Questionnaire disability index ( P = 0.047 ) .


The most frequent adverse events reported with NNC0109-0012 were injection site reactions and infections ( e.g. , herpes , nasopharyngitis , respiratory , and urinary ) .


No serious infections or discontinuations associated with NNC0109-0012 were observed .


In this phase IIa trial , treatment with NNC0109-0012 ( anti-IL-20 mAb ) was effective in patients with seropositive RA as early as week 1 , with further improvements to week 12 .


No safety or tolerability concerns were identified with weekly NNC0109-0012 administration .


Lanthanum carbonate ( LC ) , an effective non-calcium phosphate binder is widely used to manage hyperphosphatemia in patients with chronic kidney disease ( CKD ) on dialysis .


Recently , the additional indication for control of hyperphosphatemia in CKD patients not on dialysis has been approved .


A multicenter , randomized , double-blind , placebo-controlled trial to confirm the efficacy and safety of LC in Japanese hyperphosphatemic stage 4 - 5 CKD patients not on dialysis .


After a 4-week run-in period , 143 eligible subjects with serum phosphate levels of 5.6 - 11.0 mg/dL were randomized ( 2 : 1 ) to receive LC or placebo ( 88 vs. 55 ) for 8 weeks ; 119 subjects completed the study ( 76 vs. 43 ) .


The starting LC dose was 750 mg/day , which was then up-titrated to 2,250 mg/day as needed while tolerated .


Primary efficacy analysis was performed on the intent-to-treat ( ITT ) population of 141 patients ( 86 vs. 55 ) .


LC produced a significantly greater reduction in serum phosphate level compared with placebo after 8 weeks of treatment ( difference , 0.97 ( 95 % CI : 0.58 , 1.37 ) mg / dL ; p < 0.0001 ) .


The cumulative proportion of subjects with controlled phosphate levels 4.6 mg/dL was higher in the LC group than the placebo group ( 59.56 % vs. 10.46 % ) .


LC caused significantly greater reductions in serum Ca P product and urinary phosphate excretion compared with placebo .


The safety profile of LC was similar to that of placebo .


This study demonstrated the effectiveness of LC to control hyperphosphatemia in pre-dialysis CKD patients .


The objective of this study was to assess the effect of a yoga intervention on psychological health in older adults .


A randomized controlled trial study , conducted at 2 North Florida facilities for older adults .


Subjects were 98 older adults , ages 65 to 92 .


Participants were randomly assigned to chair yoga , chair exercise , and control groups and assessed preintervention , postintervention , and 1-month follow-up on the State Anger Expression Inventory , State Anxiety Inventory , Geriatric Depression Scale , Lawton 's PGC Morale Scale , General Self-Efficacy Scale , Chronic Disease Self-Efficacy Scales , and Self - Control Schedule .


Yoga participants improved more than both exercise and control participants in anger ( Cohen 's d = 0.89 for yoga versus exercise , and 0.90 for yoga versus control , pretest to posttest ; and d = 0.90 and 0.72 , pretest to follow-up ) , anxiety ( d = 0.27 , 0.39 and 0.62 , 0.63 ) , depression ( d = 0.47 , 0.49 and 0.53 , 0.51 ) , well-being ( d = 0.14 , 0.49 and 0.25 , 0.61 ) , general self-efficacy ( d = 0.63 , 1.10 and 0.30 , 0.85 ) , and self-efficacy for daily living ( d = 0.52 , 0.81 and 0.27 , 0.42 ) .


Changes in self-control moderated changes in psychological health .


Over a 6-week period , our findings indicate yoga 's potential for improving psychological health in older adults .


To analyze the incidence of surgical site infection when the preoperative skin preparation was performed with 10 % povidone-iodine and 0.5 % chlorhexidine-alcohol .


We conducted a randomized , longitudinal study based on variables obtained from patients undergoing clean and potentially contaminated operations .


Those involved were divided into two groups .


In group 1 ( G1 ) we included 102 patients with skin prepared with povidone-iodine , and in group 2 ( G2 ) , 103 , whose skin was prepared with chlorhexidine .


In the third , seventh and 30th postoperative days we evaluated the surgical site , searching for signs of infection .


Data related to clinical profile , such as diabetes mellitus , smoking , alcoholism , haematological data ( Hb , VG and leukocytes ) , age and gender , and the related variables , such as number of days of preoperative hospitalization , shaving , topography of incision , antibiotic prophylaxis and resident participation in the operation were not predisposing factors for surgical site infection .


Two patients in G1 and eight in G2 undergoing clean operations had some type of infection ( p = 0.1789 ) , five in G1 and three in G2 undergoing potentially contaminated operations had some type of infection ( p = 0.7205 ) .


The incidence of surgical site infection in operations classified as clean and as potentially contaminated for which skin preparation was done with 10 % povidone-iodine and 0.5 % chlorhexidine-alcohol was similar .


We report the efficacy and safety of levofloxacin versus rifampicin in tuberculous meningitis ( TBM ) .


In this open-label , randomized controlled trial from India , patients with TBM diagnosed on the basis of clinical , MRI and CSF findings were included .


Patients with hepatic or renal dysfunction , organ transplantation , malignancy , pregnancy , lactation , allergy , seizure , age < 15 years and antitubercular treatment 1 month were excluded .


Sixty patients each were randomized to levofloxacin ( 10 mg/kg , maximum 500 mg ) or rifampicin ( 10 mg/kg , maximum 450 mg ) .


They also received isoniazid , pyrazinamide , ethambutol , prednisolone and aspirin .


The primary outcome was death and secondary outcome measures were 6 month disability , repeat MRI changes and serious adverse events ( SAEs ) .


The median age of the patients was 34.5 ( 16-75 ) years .


The baseline clinical and MRI findings were similar between the two groups .


At 6 months , 13 out of 60 ( 21.7 % ) patients in the levofloxacin arm and 23 out of 60 ( 38.3 % ) patients in the rifampicin arm had died ( P = 0.07 ) .


On Cox regression analysis , survival in the levofloxacin group was significantly better than in the rifampicin group ( hazard ratio 2.13 , 95 % CI 1.04-4 .34 , P = 0.04 ) .


The functional outcome ( P = 0.47 ) was , however , not significantly different between the two groups .


On intention-to-treat analysis , 10 out of 47 ( 21.3 % ) in the levofloxacin arm and 5 out of 37 ( 13.5 % ) in the rifampicin arm had poor recovery .


Repeat MRI findings did not differ between the groups .


Levofloxacin was discontinued more frequently than rifampicin due to SAEs ( 16 versus 4 , P = 0.01 ) .


Levofloxacin is superior to rifampicin in reducing 6 month death in TBM but not disability .


Levofloxacin may be used in TBM especially in those patients with hepatotoxicity and without seizure .


Neuromuscular blocking drugs have been implicated in intraoperative bronchoconstrictive episodes .


We examined the effects of clinically relevant doses of cisatracurium and rocuronium on the lung mechanics of pediatric subjects .


We hypothesized that cisatracurium and rocuronium would have bronchoconstrictive effects .


We studied ASA physical status I and II pediatric subjects having elective dental or urological procedures , requiring general anesthesia with endotracheal intubations with either cisatracurium or rocuronium .


Pulmonary function tests were performed before and after neuromuscular blocking drug dosing and again after albuterol administration .


Using forced deflation and passive deflation techniques , forced vital capacity ( FVC ) and maximum expiratory flow rate at 10 % ( MEF10 ) of FVC were obtained .


Fractional changes from the baseline were used to compare subjects .


Changes in MEF10 of > 30 % were considered clinically significant .


A Shapiro-Wilk test , paired t test , and Wilcoxon rank sum test were used to analyze the data .


Twenty-five subjects ( median age = 5.25 years ; range = 9 months-9 .9 years ) were studied ; 12 subjects received cisatracurium and 13 subjects received rocuronium .


Data are shown as mean proportional change SD or , in the case of not normally distributed , median proportional change ( first , third quartile ) with P values .


In the cisatracurium group , there were no differences between baseline and postneuromuscular blocker administration in the fractional change from the baselines of FVC ( 1.00 0.04 , P = 0.5 ) , but there was a significant decrease in MEF10 ( 0.80 0.18 , P = 0.002 ) .


In the rocuronium group , there were small yet significant decreases of FVC ( 0.99 [ first quartile 0.97 , third quartile 1 ] , P = 0.02 ) and significant decreases in MEF10 ( 0.78 0.26 , P = 0.008 ) .


After administration of albuterol in the cisatracurium group , FVC increased slightly but significantly from baseline values ( 1.02 0.02 , P = 0.005 ) .


MEF10 increased significantly beyond baseline values ( 1.24 0.43 , P = 0.04 ) .


In the rocuronium group , there were also significant differences between baseline and postalbuterol administration from the baseline value of FVC ( 1.02 0.02 , P = 0.004 ) and MEF10 ( 1.23 0.29 , P = 0.01 ) .


At clinically relevant doses , both cisatracurium and rocuronium caused changes in lung function , indicating constriction of smaller airways .


In general , these changes were mild and not clinically detectable .


However , in the rocuronium group , 3 of 13 patients showed more noticeable decreases in MEF10 ( 50 % ) , demonstrating the potential for significant broncho-bronchiolar constriction in susceptible patients .


In the PARAMOUNT ( `` A Phase 3 , Double-Blind , Placebo-Controlled Study of Maintenance Pemetrexed plus Best Supportive Care vs. Best Supportive Care Immediately Following Induction Treatment with Pemetrexed Plus Cisplatin for Advanced Non-Squamous Non-Small-Cell Lung Cancer '' ) trial , patients with advanced nonsquamous non-small-cell lung cancer ( NS-NSCLC ) benefited from pemetrexed maintenance therapy after induction therapy with pemetrexed and cisplatin by extending survival , delaying disease progression , and maintaining quality of life ( QoL ) .


However , low-grade 1 or 2 toxicities during long-term maintenance treatment may become burdensome and impact QoL .


Patients in this double-blind study ( n = 539 ) , who had completed 4 induction cycles ( pemetrexed with cisplatin ) without progressive disease ( PD ) and had an ECOG performance status of 0/1 , were randomized 2:1 to pemetrexed maintenance ( 500 mg/m ( 2 ) , day 1 ) plus best supportive care ( BSC ) or placebo plus BSC until PD .


Adverse events ( by maximum Common Terminology Criteria for Adverse Events [ CTCAE ] grade ) and QoL ( EuroQol 5-dimensional [ EQ-5D ] scale ) were assessed .


A median of 4 maintenance cycles was administered ( range , pemetrexed 1-44 ; mean SD 7.9 8.3 ; placebo 1-38 ; mean SD 5.0 5.2 ) , with 28 % of pemetrexed and 12 % of placebo patients receiving 10 maintenance cycles .


The pemetrexed dose intensity was 94 % .


More patients receiving pemetrexed ( 12 % ) than placebo discontinued because of possible drug-related CTCAEs ( 4 % ; P = .005 ) .


Overall , pemetrexed was associated with significantly more ( P < .05 ) low-grade events ( grade 1/2 nausea , grade 2 anemia , edema , and neutropenia ) than placebo .


Overall , the incidence of low-grade fatigue , anemia , and neutropenia decreased with long-term pemetrexed exposure ; however , renal events increased across treatment arms .


EQ-5D analyses demonstrated no treatment-by-time interaction or overall treatment differences between the 2 arms .


PARAMOUNT demonstrated a low incidence of low-grade toxicities with long-term pemetrexed exposure without compromising QoL in patients with NS-NSCLC .


To explore the application of the Dexmedetomidine utend drug induced sleep endoscopy .


Forty-four OSAHS patients diagnosed by PSG randomly were divided into group A ( Dexmedetomidine group ) and group B ( Propofol group ) , each group of 22 cases .


Group A : pump the Dexmedetomidine ( 1 microg/kg ) over 15 minutes .


Once the patient reached a satisfactory level of sedation , the electronic nasopharyngoscope was introduced into the nasal cavity group B : the propofol ( 2 mg/kg ) was intravenous injected , use the same exmination after the object patients falling asleep .


If not , double the injection dose of the two group .


Observe and record the patient vital signs , EEG and sleep time , and handle the complications .


The study was successfully completed both in group A and B. Mean arterial pressure ( MAP ) in group B was lower than group A during the examination significantly ( P < 0.05 ) .


The time falling to sleep in two groups were ( 13.4 + / - 2.5 ) min and ( 6.6 + / - 1.2 ) min , and the time in group A was much longer than that in group B.


The lowest oxygen saturation during the examination in two groups were 0.835 + / - 0.096 and 0.691 + / - 0.095 , and the difference was statistically significant .


There was no incidence of adverse reactions in two groups .


Compared with propofol , Dexmedetomidine is a safer sleep-inducing drug , and it can be used for clinical sleep endoscopy .


Patient engagement in health care is increasingly recognized as essential for promoting the health of individuals and populations .


This study pilot tested the standardized clinician ( SC ) methodology , a novel adaptation of standardized patient methodology , for teaching patient engagement skills for the complex health care situation of transitioning from a hospital back to home .


Sixty-seven participants at heightened risk for hospitalization were randomly assigned to either simulation exposure-only or full-intervention group .


Both groups participated in simulation scenarios with `` standardized clinicians '' around tasks related to hospital discharge and follow-up .


The full-intervention group was also debriefed after scenario sets and learned about tools for actively participating in hospital-to-home transitions .


Measures included changes in observed behaviors at baseline and follow-up and an overall program evaluation .


The full-intervention group showed increases in observed tool possession ( P = 0.014 ) and expression of their preferences and values ( P = 0.043 ) .


The simulation exposure-only group showed improvement in worksheet scores ( P = 0.002 ) and fewer engagement skills ( P = 0.021 ) .


Both groups showed a decrease in telling an SC about their hospital admission ( P < 0.05 ) .


Open-ended comments from the program evaluation were largely positive .


Both groups benefited from exposure to the SC intervention .


Program evaluation data suggest that simulation training is feasible and may provide a useful methodology for teaching patient skills for active engagement in health care .


Future studies are warranted to determine if this methodology can be used to assess overall patient engagement and whether new patient learning transfers to health care encounters .


We investigated the relative pharmacokinetics , pharmacodynamics , and safety of the proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) inhibitor alirocumab following injection at three different sites .


Sixty healthy subjects ( 39 male , 21 female ; age 20-45 years ) were randomized to receive a single subcutaneous injection of alirocumab 75 mg via 1-mL prefilled pen into the abdomen , upper arm , or thigh ( NCT01785329 ) .


Subjects were followed for 85 days 2 days following study drug administration .


Pharmacokinetic ( PK ) parameters for the systemic exposure of alirocumab were calculated , and levels of free PCSK9 were assessed .


Percentage changes from baseline in LDL-C were compared between injection site groups using linear mixed-effects models .


Alirocumab concentration-time profiles were similar , and free PCSK9 levels were reduced to approximately zero between Day 3 and Day 4 postinjection in all groups .


LDL-C levels reached nadir on Day 15 postinjection in all groups with mean percentage reductions of 48.4 % ( abdomen ) , 39.5 % ( upper arm ) , and 45.6 % ( thigh ) at this time point .


A similar effect on LDL-C levels was seen across the entire time course of the study at all three injection sites .


Treatment-emergent adverse events were experienced by 8/20 ( abdomen ) , 11/20 ( upper arm ) , and 13/20 ( thigh ) subjects .


There were 2 mild/transient injection site reactions .


There were no serious adverse events .


A single subcutaneous administration of alirocumab 75 mg via prefilled pen was well tolerated with similar pharmacokinetics and pharmacodynamics when injected into the abdomen , upper arm , or thigh .


These results suggest that alirocumab can be interchangeably injected in the abdomen , upper arm , or thigh .


Diets where carbohydrate has been partially exchanged for protein have shown beneficial changes in persons with type 2 diabetes but no studies have enrolled people with albuminuria .


We aim to determine if a high protein to carbohydrate ratio ( HPD ) in an energy reduced diet has a beneficial effect on metabolic control and cardiovascular risk factors without negatively affecting renal function .


Adult , overweight participants with type 2 diabetes , with albuminuria ( 30-600 mg/24 h or an albumin-to-creatinine ratio of 3.0-60 mg/mmol ) , and estimated GFR of > 40 ml/min/1 .73 m ( 2 ) were enrolled .


Participants were randomized to an HPD or an SPD .


Protein : fat : carbohydrate ratio was 30:30:40 % of energy for the HPD and 20:30:50 % for the SPD .


Main outcomes were renal function , weight loss , blood pressure , serum lipids and glycaemic control .


We recruited 76 volunteers and 45 ( 35 men and 10 women ) finished .


There were no overall changes in renal function at 12 months and no significant differences in weight loss between groups ( 9.7 2.9 kg and 6.6 1.4 kg HPD and SPD group respectively ; p = 0.32 ) .


Fasting blood glucose decreased significantly with no treatment effect .


The decrease in HbA1c differed between treatments at 6 months ( HPD -0.9 vs. SPD -0.3 % ; p = 0.039 ) but not at 12 months .


HDL increased significantly with no treatment effects .


There were no changes in LDL or blood pressure overall but DBP was lower in the HPD group ( p = 0.024 ) at 12 months .


Weight loss improved overall metabolic control in this group of well controlled participants with type 2 diabetes regardless of diet composition .


Orally administered chemical thromboprophylactic agents for total hip replacement ( THR ) have become popular in recent years .


Certain clinical trials suggest that the efficacy and the risk of major bleeding after administration of direct thrombin inhibitor dabigatran etexilate are equivalent to the clinical trial comparator , subcutaneous low-molecular-weight heparin enoxaparin .


Our aim was to compare and evaluate the incidence of minor haemorrhagic and soft-tissue adverse effects of enoxaparin and dabigatran .


122 patients who were treated by elective cemented primary THR were enrolled in our quasi-randomised study .


Two groups were formed according to which perioperative thromboprophylactic agent was used : 61 patients in enoxaparin group versus 61 patients in dabigatran group .


Thigh volume changes , calculated perioperative blood loss , area of haematoma , wound bleeding , duration of wound discharge and intensity of serous wound discharge on postoperative day 3 and day 7 were recorded .


The duration and intensity of serous wound discharge differed significantly between the two groups .