Mean WAZ and LAZ were below average relative to the general population at birth ( P < 0.001 , P = 0.05 , respectively ) and age 3 years ( P < 0.001 each ) .


The largest decrease in WAZ occurred between birth and Norwood discharge ; the greatest gain occurred between stage II and 14 months .


At age 3 years , WAZ and LAZ were < -2 in 6 % and 18 % , respectively .


Factors associated with change in WAZ differed among time periods .


Shunt type was associated with change in WAZ only in the Norwood discharge to stage II period ; subjects with a Blalock-Taussig shunt had a greater decline in WAZ than those with a right ventricle-pulmonary artery shunt ( P = 0.002 ) .


WAZ changed over time and the predictors of change in WAZ varied among time periods .


By age 3 years , subjects remained small and three times as many children were short as were underweight ( > 2 SD below normal ) .


Failure to find consistent risk factors supports the strategy of tailoring nutritional therapies to patient - and stage-specific targets .


http://clinicaltrials.gov/ .


Unique identifier : NCT00115934 .


Fingolimod , a sphingosine 1-phosphate receptor modulator , is the first oral disease modifying therapy approved for the treatment of relapsing multiple sclerosis .


The aim of this double-blind , placebo-controlled study was to evaluate the effect of fingolimod on cerebral blood flow , platelet function and macular thickness in healthy volunteers .


The study included 88 healthy volunteers who received fingolimod 0.5 mg or 1.25 mg or matched placebo over a period of 4 weeks .


Transcranial colour coded sonography was performed to measure mean blood flow velocities , the platelet function was measured by the PFA-100 assay using a collagen/epinephrine cartridge and macular thickness was measured using optical coherence tomography .


An assessment of non-inferiority of fingolimod vs. placebo was performed against a reference value ( 20 % of the overall baseline value ) .


All 88 randomized participants completed the study .


At day 28 compared with baseline value , for 0.5 mg , 1.25 mg and placebo treatments , the mean middle cerebral artery blood flow velocity decreased by 4 , 1 and 3.7 cms ( -1 ) , respectively .


The platelet function analyzer closure time increase was not significant ( 7.8 , 7.5 and 10.4 s , respectively ) .


The mean percentage change in the central foveal thickness from baseline for both eyes was below 3 % for all groups .


The safety profile of fingolimod in this study was found consistent with the previous reports .


In healthy volunteers , the changes seen with both fingolimod doses were found to be within normal variability , non-inferior and comparable with those observed with placebo for all the pharmacodynamic parameters assessed .


Cancer survivors often experience decreased self-confidence which impacts negatively on their ability to self-manage the practical , social and emotional problems frequently faced as they emerge from end of treatment .


This was a feasibility study of a life-coaching intervention , designed to rebuild confidence of survivors and support transition to life after cancer treatment .


A one group pre-test , post-test design was used , recruiting participants from community organisations .


Eligibility criteria are as follows : < 1 year of completion of primary cancer treatment , aged > 18 , no metastases , and no mental health problems .


Participants received one individualised face-to-face and five telephone coaching sessions over 3 months .


Outcome measures are as follows : New General Self-Efficacy Scale , Hope Scale , Personal Well-being Index , Assessment of Survivorship Concerns , Quality of Life in Adult Cancer Survivors , Hospital Anxiety and Depression Scale , Social Difficulties Index , and a goal attainment score .


Interviews explored feasibility , acceptability and impact of life-coaching and research design .


Nine women and two men were recruited , representing varying cancer diagnoses .


All outcome measures were sensitive to change and indicated positive trends post-intervention .


Participant interviews indicated the intervention was well received and had a positive impact .


Lessons were learnt about study design , recruitment and intervention delivery .


Life-coaching has a potential to enable cancer survivors to manage the transition to life beyond cancer and effect change on a range of outcomes .


The intervention was feasible to deliver and acceptable to survivors at a time when many struggle to make sense of life .


It merits further evaluation through a randomised controlled trial .


of the study was to assess efficacy of the use of fixed combination of nebivolol and amlodipine in patients with moderate and high degree of arterial hypertension ( AH ) .


Patients with diagnosis of primary AH ( n = 124 ) were divided into 2 groups by random sample method .


Patients of group 1 ( n = 62 ) received of fixed combination of nebivolol and amlodipine , while those of group 2 ( n = 62 ) received free combination of nebivolol and amlodipine .


Study drugs were administered both as initial therapy and replacement of preceding treatment .


Duration of observation was 3 months with visits after first 2 weeks and in 1 , 2 , and 3 months after enrollment .


Starting from 2nd week visit of fixed combination of nebivolol and amlodipine treated patients had significantly lower levels of systolic and diastolic AP .


Already after 2 weeks of combined two-component therapy 60 % of group 1 and 52 % of group 2 patients achieved target AP .


Target AP was achieved by the end of month 1 by 86 and 71 % , of month 2 - by 93 and 78 % of patients in groups 1 and 2 , respectively .


In 3 months almost all patients had target AP , but in 1.6 % of group 1 and 2.3 % of group 2 patients this level was achieved after addition of a thiazide diuretic .


Patients receiving of fixed combination of nebivolol and amlodipine achieved noromosyslolia more quickly compared with patients who received free combination of nebivolol and amlodipine .


Combined therapy with fixed combination of nebivolol and amlodipine appears to be one of effective approaches to treatment of patients with moderate and high degree AH .


CG100649 , a novel selective cyclooxygenase-2 inhibitor that also inhibits carbonic anhydrase I/II , is expected to reduce the cardiovascular risk typical of other NSAIDs .


Concurrent medications may influence the activities of the cytochrome P450 ( CYP ) 3A enzyme through which CG100649 is metabolized .


This study was designed to evaluate the influence of ketoconazole , a known strong inhibitor of CYP3A , on the pharmacokinetic properties of CG100649 .


This randomized , open-label , 2 2 crossover study was conducted in healthy Korean male volunteers .


Each subject received the following 2 treatments in a randomly allocated sequence , separated by a washout period of 42 days : single oral dose of CG100649 6 mg , and concurrent dosing of CG100649 6 mg and ketoconazole 400 mg followed by ketoconazole 400 mg/d over 4 days .


Blood samples for pharmacokinetic analysis were collected at 0 ( predose ) , 0.5 , 1 , 1.5 , 2 , 3 , 4 , 6 , 8 , 10 , 12 , 24 , 36 , 48 , 72 , 96 , 120 , 144 , 240 , 384 , and 480 hours after dosing of CG100649 in each sequence .


Tolerability assessments were performed throughout the study .


Thirty subjects participated , and 26 subjects completed the study .


Seventeen adverse events ( AEs ) were reported in 10 subjects , and all AEs were recovered without any sequelae .


No serious AEs were reported .


Six subjects receiving the single dose of CG100649 had 9 AEs , and 7 subjects receiving the combination of ketoconazole and CG100649 had 8 AEs .


The Cmax of CG100649 with CG100649 only and with concurrent administration of CG100649 + ketoconazole were similar ( 10.7 and 11.0 ng/mL , respectively ) .


The CG100649 AUClast with concurrent ketoconazole was 1.29-fold greater than that with CG100649 only ( 2074.0 and 2685.8 ng h/mL ) and demonstrated a statistically significant difference ( P < 0.05 ) .


However , there were no statistically significant differences in vital signs , clinical laboratory test results , ECGs , or AEs between treatments .


Although the AUC of CG100649 increased by 29 % with the concurrent medication of ketoconazole , it is considered that concurrent administration of CG100649 with ketoconazole would not change the safety profile of CG100649 .


Advanced glycation endproducts ( AGEs ) contribute to the development of vascular complications of diabetes and have been recently implicated in the pathogenesis of diabetes .


Since AGEs are generated within foodstuffs upon food processing , it is increasingly recognised that the modern diet is replete with AGEs .


AGEs are thought to stimulate chronic low-grade inflammation and promote oxidative stress and have been linked to the development of insulin resistance .


Simple therapeutic strategies targeted at attenuating the progression of chronic low-grade inflammation and insulin resistance are urgently required to prevent or slow the development of type 2 diabetes in susceptible individuals .


Dietary modulation of the human colonic microbiota has been shown to confer a number of health benefits to the host , but its effect on advanced glycation is unknown .


The aim of this article is to describe the methodology of a double-blind placebo-controlled randomised crossover trial designed to determine the effect of 12week consumption of a prebiotic dietary supplement on the advanced glycation pathway , insulin sensitivity and chronic low-grade inflammation in adults with pre-diabetes .


Thirty adults with pre-diabetes ( Impaired Glucose Tolerance or Impaired Fasting Glucose ) aged between 40-60 years will be randomly assigned to receive either 10 grams of prebiotic ( inulin/oligofructose ) daily or 10 grams placebo ( maltodextrin ) daily for 12weeks .


After a 2-week washout period , study subjects will crossover to receive the alternative dietary treatment for 12weeks .


The primary outcome is the difference in markers of the advanced glycation pathway carboxymethyllysine ( CML ) and methylglyoxal ( MG ) between experimental and control treatments .


Secondary outcomes include HbA1c , insulin sensitivity , lipid levels , blood pressure , serum glutathione , adiponectin , IL-6 , E-selectin , myeloperoxidase , C-reactive protein , Toll-like Receptor 4 ( TLR4 ) , soluble receptor for AGE ( sRAGE ) , urinary 8-isoprostanes , faecal bacterial composition and short chain fatty acid profile .


Anthropometric measures including BMI and waist circumference will be collected in addition to comprehensive dietary and lifestyle data .


Prebiotics which selectively stimulate the growth of beneficial bacteria in the human colon might offer protection against AGE-related pathology in people at risk of developing type 2 diabetes .


Australia and New Zealand Clinical Trials Register ( ANZCTR ) : ACTRN12613000130763 .


The 2013 GOLD classification system for COPD distinguishes four stages : A ( low symptoms , low exacerbation risk ) , B ( high symptoms , low risk ) , C ( low symptoms , high risk ) and D ( high symptoms , high risk ) .


Assessment of risk is based on exacerbation history and airflow obstruction , whatever results in a higher risk grouping .


The previous system was solely based on airflow obstruction .


Earlier studies compared the predictive performance of new and old classification systems with regards to mortality and exacerbations .


The objective of this study was to compare the ability of both classifications to predict the number of future ( total and severe ) exacerbations and mortality in a different patient population , and to add an outcome measure to the comparison : lung function decline .


Patient-level data from the UPLIFT trial were used to analyze 4-year survival in a Weibull model , with GOLD stages at baseline as covariates .


A generalized linear model was used to compare the numbers of exacerbations ( total and severe ) per stage .


Analyses were repeated with stages C and D divided into substages depending on lung function and exacerbation history .


Lung function decline was analysed in a repeated measures model .


Mortality increased from A to D , but there was no difference between B and C. For the previous GOLD stages 2-4 , survival curves were clearly separated .


Yearly exacerbation rates were : 0.53 , 0.72 and 0.80 for stages 2-4 ; and 0.35 , 0.45 , 0.58 and 0.74 for A-D .


Annual rates of lung function decline were : 47 , 38 and 26ml for stages 2-4 and 44 , 48 , 38 and 39 for stages A-D .


With regards to model fit , the new system performed worse at predicting mortality and lung function decline , and better at predicting exacerbations .


Distinguishing between the sub-stages of high-risk led to substantial improvements .


The new classification system is a modest step towards a phenotype approach .


It is probably an improvement for the prediction of exacerbations , but a deterioration for predicting mortality and lung function decline .


ClinicalTrials.gov NCT00144339 ( September 2 , 2005 ) .


To estimate whether continuous combined oral contraceptive pill ( OCP ) use leads to higher continuation and lower pregnancy rates over 12 months than cyclic use in a developing country setting .


We enrolled healthy women aged 18 to 30 years , in Santo Domingo , Dominican Republic .


We randomly assigned women to cyclic or continuous use of OCPs .


Participants made quarterly clinic visits for 12 months .


During follow-up , we reviewed OCP adherence and continuation , side effects , and bleeding , and we tested for pregnancy .


We enrolled 358 women ( mean age , 22.7 years ) and 335 ( 93.6 % ) completed the study .


In intent-to-treat analyses , 77.6 % of the continuous use group and 71.7 % of the cyclic group continued OCPs at 12 months ( P = .21 ) .


The main reason for OCP discontinuation in both groups was running out of OCPs or forgetting .


Across all visits , 26.1 % of women in the continuous use group and 22.3 % of women in the cyclic group ever reported missing three or more OCPs in the past month ( P = .43 ) .


In multivariable analyses , regimen was not associated with discontinuation , but both previous birth and perceived ease of use of OCPs decreased risk of discontinuation , whereas desire for reduced menstruation increased risk of discontinuation .


Although more women reported amenorrhea or infrequent bleeding in the continuous use group , more women in the cyclic group found their bleeding patterns acceptable .


Bleeding was not associated with discontinuation in multivariable analyses .


Pregnancy rates at 12 months were similar ( 16.2 % continuous and 17.4 % cyclic ) .


Continuous and cyclic OCP regimens were associated with similar 12-month continuation and pregnancy rates .


Few factors predicted OCP discontinuation or pregnancy .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT00570440 .


I.


Project Renaissance is a randomized controlled trial of an HIV/hepatitis C virus ( HCV ) / sexually transmitted infection ( STI ) prevention intervention conducted in Almaty , Kazakhstan .


We hypothesized that couples assigned to the intervention of interest will have lower incidence of HIV , HCV , STIs , rates of unprotected sex , and unsafe injection over the 12-month follow-up period compared with those assigned to an attention control arm .


A total of 300 couples ( 600 participants ) where one or both partners reported injecting drugs in the past 90 days were randomized to 1 of 2 arms : ( 1 ) a 5-session HIV/HCV/STI prevention intervention ( risk reduction : RR ) or ( 2 ) a 5-session Wellness Promotion ( WP ) intervention .


Over the 12-month follow-up period , assignment to RR compared with WP significantly lowered the incidence of HCV infection by 69 % [ incidence rate ratios ( IRR ) = 0.31 , 95 % ( CI ) confidence interval : 0.10 to 0.90 , P = 0.031 ] .


Although differences were not statistically significant , RR participants had a lower incidence of HIV infection by 51 % ( IRR = 0.49 , 95 % CI : 0.16 to 1.48 , P = 0.204 ) and any STI by 37 % ( IRR = 0.63 , 95 % CI : 0.21 to 1.93 , P = 0.418 ) than WP participants .


RR participants reported significantly fewer numbers of unprotected vaginal sex acts with their study partners ( IRR = 0.58 , 95 % CI : 0.36 to 0.93 , P = 0.024 ) and more consistent condom use ( odds ratios = 2.30 , 95 % CI : 1.33 to 4.00 , P = 0.003 ) over the entire follow-up period compared with WP participants .


Project Renaissance demonstrated a significant effect for biological and behavioral endpoints .


Findings draw attention to an HIV/HCV/STI prevention intervention strategy that can be scaled up for drug-involved couples in harm reduction programs , drug treatment , and criminal justice settings .


To compare the effectiveness of fluoride vanish , fluoride foam , pit and fissure sealant with fluoride in prevention of dental caries , and investigate appropriate approach to prevent dental caries at schools .


A randomized controlled clinical trial with 4 parallel groups was conducted .


Totally 1016 children from 4 schools and 33 classes with a mean age of 7 to 8 years were included .


They were randomly allocated into 4 groups : ( 1 ) fluoride vanish , semi-annual application ; ( 2 ) fluoride foam , semi-annual application ; ( 3 ) resin sealant , single placement ; and ( 4 ) placebo control with oral hygiene instruction .


Follow-up examinations were conducted after 2 years to monitor dental caries increment of first molars among these children .


Data analysis was performed using SPSS 18.0 software package .


Two years later , 977 children ( 96.2 % ) were examined .


The results of multiple factor ANCOVA showed that fluoride vanish and resin sealant had significantly lower mean dental caries increment on tooth surface compared with control group ( P < 0.05 ) .


No significant difference of mean dental caries increment on tooth surface was found between fluoride foam and control group ( P > 0.05 ) .


The placement of resin sealant with fluoride and annual application of fluoride protector are effective in prevention of dental caries in permanent teeth of children .


Clostridium difficile is the most common cause of health care-associated infection in US hospitals .


Recurrence occurs in 25 % to 30 % of patients .


To determine the safety , fecal colonization , recurrence rate , and optimal dosing schedule of nontoxigenic C. difficile strain M3 ( VP20621 ; NTCD-M3 ) for prevention of recurrent C. difficile infection ( CDI ) .


Phase 2 , randomized , double-blind , placebo-controlled , dose-ranging study conducted from June 2011 to June 2013 among 173 patients aged 18 years or older who were diagnosed as having CDI ( first episode or first recurrence ) and had successfully completed treatment with metronidazole , oral vancomycin , or both at 44 study centers in the United States , Canada , and Europe .


Patients were randomly assigned to receive 1 of 4 treatments : oral liquid formulation of NTCD-M3 , 10 ( 4 ) spores/d for 7 days ( n = 43 ) , 10 ( 7 ) spores/d for 7 days ( n = 44 ) , or 10 ( 7 ) spores/d for 14 days ( n = 42 ) , or placebo for 14 days ( n = 44 ) .


The primary outcome was safety and tolerability of NTCD-M3 within 7 days of treatment .


Exploratory secondary outcomes included fecal colonization with NTCD-M3 from end of study drug through week 6 and CDI recurrence from day 1 through week 6 .


Among 168 patients who started treatment , 157 completed treatment .


One or more treatment-emergent adverse events were reported in 78 % of patients receiving NTCD-M3 and 86 % of patients receiving placebo .


Diarrhea and abdominal pain were reported in 46 % and 17 % of patients receiving NTCD-M3 and 60 % and 33 % of placebo patients , respectively .


Serious treatment-emergent adverse events were reported in 7 % of patients receiving placebo and 3 % of all patients who received NTCD-M3 .


Headache was reported in 10 % of patients receiving NTCD-M3 and 2 % of placebo patients .


Fecal colonization occurred in 69 % of NTCD-M3 patients : 71 % with 10 ( 7 ) spores/d and 63 % with 10 ( 4 ) spores/d .


Recurrence of CDI occurred in 13 ( 30 % ) of 43 placebo patients and 14 ( 11 % ) of 125 NTCD-M3 patients ( odds ratio [ OR ] , 0.28 ; 95 % CI , 0.11-0 .69 ; P = .006 ) ; the lowest recurrence was in 2 ( 5 % ) of 43 patients receiving 10 ( 7 ) spores/d for 7 days ( OR , 0.1 ; 95 % CI , 0.0-0 .6 ; P = .01 vs placebo ] ) .


Recurrence occurred in 2 ( 2 % ) of 86 patients who were colonized vs 12 ( 31 % ) of 39 patients who received NTCD-M3 and were not colonized ( OR , 0.01 ; 95 % CI , 0.00-0 .05 ; P < .001 ) .


Among patients with CDI who clinically recovered following treatment with metronidazole or vancomycin , oral administration of spores of NTCD-M3 was well tolerated and appeared to be safe .


Nontoxigenic C. difficile strain M3 colonized the gastrointestinal tract and significantly reduced CDI recurrence .


clinicaltrials.gov Identifier : NCT01259726 .


Untreated behavioral and mental health problems beginning in early childhood are costly problems affecting the long-term health and wellbeing of children , their families , and society .


Although parent training ( PT ) programs have been demonstrated to be a cost-effective intervention modality for treating childhood behavior problems , they have been less effective for children from low-income and underserved racial and ethnic populations .


The purpose of this randomized trial is to compare the effectiveness , cost , and social validity of two manualized evidence-based PT programs that were developed and tested on different populations and employ different delivery models : ( 1 ) The Chicago Parent Program ( CPP ) , a group-based program developed in collaboration with a community advisory board of African-American and Latino parents ; and ( 2 ) Parent-Child Interaction Therapy ( PCIT ) , an individualized parent-child coaching model considered to be ` the gold standard ' for parents of children with externalizing behavior problems .


This trial uses an experimental design with randomization of parents seeking behavioral treatment for their 2 - to 5-year-old children at a mental health clinic in Baltimore , MD ( 80 % African-American or multi-racial ; 97 % receiving Medicaid ) .


Using block randomization procedures , 262 parents are randomized to CPP or PCIT .


Clinicians ( n = 13 ) employed in the mental health clinic and trained in CPP or PCIT are also recruited to participate .


Primary outcomes of interest are reductions in child behavior problems , improvements in parenting , perceived value of the interventions from the perspective of parents and clinicians , and cost .


Parent distress and family social risk are assessed as modifiers of treatment effectiveness .


We hypothesize that CPP will be at least as effective as PCIT for reducing child behavior problems and improving parenting but the programs will differ on cost and their social validity as perceived by parents and clinicians .


This is the first study to compare the effectiveness of a PT program originally designed with and for parents from underserved racial and ethnic populations ( CPP ) against a well-established program considered to be the ` the gold standard ' ( PCIT ) with a high-risk population of parents .


Challenges related to conducting a randomized trial in a fee-for-service mental health clinic serving urban , low-income families are discussed .


NCT01517867 .


To compare treatment satisfaction between real-time continuous glucose monitoring ( RT-CGM ) and internet-blood glucose monitoring ( IBGM ) in adults with type 2 diabetes treated with insulin .


This study recruited 40 patients who completed a parallel randomized controlled trial comparing a RT-CGM to an IBGM .


Patients in the RT-CGM group monitored their blood-glucose levels bi-weekly and emailed results to their endocrinologist .


Patients in the IBGM group also monitored their blood-glucose levels bi-weekly , but entered their data into an IBGM .


Both groups used a secure website to submit blood-glucose readings and to receive feedback from their endocrinologist .


Feedback included changes in therapy , suggestions on testing frequency , lifestyle modifications and/or encouragement to continue with no changes .


At the end of 6 months , treatment satisfaction was measured using the 8-item Diabetes Treatment Satisfaction Questionnaire .


In this study , `` treatment '' refers to the blood glucose monitoring system to which patients were randomized .


Thirty-two of the 40 patients completed the treatment satisfaction questionnaire ( 80 % ) .


Compared to the RT-CGM group , the IBGM group reported a significantly higher level of overall treatment satisfaction ( 24.80 vs. 33.41 , p < 0.000 ) .


Ratings of individual satisfaction components including convenience , flexibility , likelihood of recommending treatment to others , and willingness to continue with treatment were also found to be significantly higher in the IBGM group .


Patients using IBGM are more satisfied with their blood glucose monitoring system compared to those using RT-CGM .


To compare the efficacy differences between fire needling therapy and oxycycline tablets for the treatment of moderate to severe acne vulgaris .


Sixty cases of moderate to severe acne vulgaris were randomly divided into a fire needling group and a medication group , 30 cases in each one .


The pricking method of fire needling at Ashi points around damaged skin was applied in the fire needling group , once every five days for totally 4 times .


The oral administration of oxycycline tablets , 100 mg , was applied in the medication group , twice daily for 20 days , also external application of adapalene gel before sleep was adopted .


The fading time of skin damage , including papule , pustule , nodule and cyst in the two groups was recorded and clinical efficacy was compared .


After the treatment , two-month follow-up was performed to observe the recurrence rate in the two groups .


The curative rate was 69.0 % ( 20/29 ) in the fire needling group , which was statistically different from 40.0 % ( 12/30 ) in the medication group ( P < 0.05 ) .


The fading time of each type of skin damage in the fire needling group was shorter than that in the medication group [ papule : ( 2.67 + / - 0.66 ) d vs ( 4.36 + / - 0.61 ) d ; pustule : ( 2.47 + / - 0.57 ) d vs ( 4.27 + / - 0.55 ) d ; nodule : ( 7.76 + / - 1.06 ) d vs ( 9.88-1 .30 ) d ; cyst : ( 11.81 + / - 1.54 ) d vs ( 14.79 + / - 0.89 ) d , all P < 0.05 ] .


The recurrence rate was 46.4 % ( 13/28 ) in the fire needling group , which was not significantly different from 44.0 % ( 11/24 ) in the medication group ( P > 0.05 ) .


The acne vulgaris could be fast and effectively treated by fire needling therapy , which has shorter fading time than oxycycline tablets .


However , the preventive effect is not different between the two theraies .


Little research has examined whether alcohol reduction interventions improve antiretroviral therapy ( ART ) adherence and HIV treatment outcomes .


This study assesses the efficacy of an intervention for reducing alcohol use among HIV patients on ART who are hazardous/harmful drinkers .


Specific aims include adapting a blended Motivational Interviewing ( MI ) and Problem Solving Therapy ( PST ) intervention for use with HIV patients ; evaluating the efficacy of the intervention for reducing alcohol consumption ; and assessing counsellors ' and participants ' perceptions of the intervention .


A randomised controlled trial will evaluate the intervention among ART patients in public hospital-based HIV clinics in Tshwane , South Africa .


We will recruit patients who are HIV-positive , on ART for at least 3months , and classified as harmful/hazardous drinkers using the AUDIT-3 .


Eligible patients will be randomly assigned to one of three conditions .


Patients in the experimental group will receive the MI-PST intervention to reduce harmful/hazardous alcohol use .


Patients in the equal-attention wellness intervention group will receive an intervention focused on addressing health risk behaviours .


Patients in the control condition will receive treatment as usual .


Participants will complete an interviewer-administered questionnaire at baseline and 3 , 6 and 12months post-randomisation to assess alcohol consumption , ART adherence , physical and mental health .


We will also collect biological specimens to test for recent alcohol consumption , CD4 counts and HIV RNA viral loads .


The primary outcome will be reduction in the volume of alcohol consumed .


Secondary outcomes include reduction in harmful/hazardous use of alcohol , reduction in biological markers of drinking , increase in adherence rates , reductions in viral loads , and increases in CD4 T-cell counts .


A process evaluation will ascertain counsellors ' and participants ' perceptions of the acceptability and effectiveness of the interventions .


We have obtained ethical approval and approval from the study sites and regional and provincial health departments .


The study has implications for clinicians , researchers and policy makers as it will provide efficacy data on how to reduce harmful/hazardous alcohol consumption among HIV patients and will shed light on whether reducing alcohol consumption impacts on HIV treatment adherence and other outcomes .


Pan African Clinical Trials Register Number : PACTR201405000815100 .


Steroidal mineralocorticoid receptor antagonists , when added to a renin-angiotensin system blocker , further reduce proteinuria in patients with chronic kidney disease but may be underused because of a high risk of adverse events .


To evaluate the safety and efficacy of different oral doses of the nonsteroidal mineralocorticoid receptor antagonist finerenone , given for 90 days to patients with diabetes and high or very high albuminuria who are receiving an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker .


Randomized , double-blind , placebo-controlled , parallel-group study conducted at 148 sites in 23 countries .


Patients were recruited from June 2013 to February 2014 and the study was completed in August 2014 .


Of 1501 screened patients , 823 were randomized and 821 received study drug .


Participants were randomly assigned to receive oral , once-daily finerenone ( 1.25 mg/d , n = 96 ; 2.5 mg/d , n = 92 ; 5 mg/d , n = 100 ; 7.5 mg/d , n = 97 ; 10 mg/d , n = 98 ; 15 mg/d , n = 125 ; and 25 mg/d , n = 119 ) or matching placebo ( n = 94 ) for 90 days .


The primary outcome was the ratio of the urinary albumin-creatinine ratio ( UACR ) at day 90 vs at baseline .


Safety end points were changes from baseline in serum potassium and estimated glomerular filtration rate .


The mean age of the participants was 64.2 years ; 78 % were male .


At baseline , 36.7 % of patients treated had very high albuminuria ( UACR 300 mg/g ) and 40.0 % had an estimated glomerular filtration rate of 60 mL/min/1 .73 m2 or lower .


Finerenone demonstrated a dose-dependent reduction in UACR .


The primary outcome , the placebo-corrected mean ratio of the UACR at day 90 relative to baseline , was reduced in the finerenone 7.5 - , 10 - , 15 - , and 20-mg/d groups ( for 7.5 mg/d , 0.79 [ 90 % CI , 0.68-0 .91 ; P = .004 ] ; for 10 mg/d , 0.76 [ 90 % CI , 0.65-0 .88 ; P = .001 ] ; for 15 mg/d , 0.67 [ 90 % CI , 0.58-0 .77 ; P < .001 ] ; for 20 mg/d , 0.62 [ 90 % CI , 0.54-0 .72 ; P < .001 ] ) .


The prespecified secondary outcome of hyperkalemia leading to discontinuation was not observed in the placebo and finerenone 10-mg/d groups ; incidences in the finerenone 7.5 - , 15 - , and 20-mg/d groups were 2.1 % , 3.2 % , and 1.7 % , respectively .


There were no differences in the incidence of the prespecified secondary outcome of an estimated glomerular filtration rate decrease of 30 % or more or in incidences of adverse events and serious adverse events between the placebo and finerenone groups .


Among patients with diabetic nephropathy , most receiving an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker , the addition of finerenone compared with placebo resulted in improvement in the urinary albumin-creatinine ratio .


Further trials are needed to compare finerenone with other active medications .


clinicaltrials.gov Identifier : NCT1874431 .


Allogeneic red blood cell ( RBC ) transfusion is associated with significant increases in mortality and major morbidity in patients admitted to the intensive care unit , and the blood supplies it requires are an increasingly scarce and costly resource .


Despite high levels of compliance with recommended transfusion thresholds in the ICU , RBC transfusion remains common .


Novel interventions to reduce the incidence of RBC transfusion are required .


To describe the study protocol for a randomised controlled trial , the Intravenous Iron or Placebo for Anaemia in Intensive Care ( IRONMAN ) trial , comparing intravenous ( IV ) iron with placebo in patients who are admitted to an ICU and are anaemic .


A Phase IIb multicentre , randomised , placebo-controlled trial .


Patients admitted to the ICU with a haemoglobin ( Hb ) level < 100 g/L and predicted to require critical care beyond the next calendar day will be randomly assigned in a 1 : 1 ratio to receive IV ferric carboxymaltose ( 500 mg ) or placebo .


The primary end point will be the mean number of RBC units transfused from study enrolment to discharge from hospital .


Secondary end points will include change in Hb level and incidence of nosocomial infection .


The IRONMAN trial is designed to determine whether IV iron administered to patients admitted to an ICU and who are anaemic is associated with a reduction in RBC transfusion , compared with placebo in addition to standard care .


The results of this trial may determine whether a Phase III trial of IV iron in ICUs is feasible .


Australian New Zealand Clinical Trials Registry ( ACTRN12612001249842 ) .


To assess and compare the efficacy of single buccal and palatal infiltration of lidocaine , mepivacaine , or articaine with 1:100000 epinephrine by maxillary anesthetic injection .


A double-blinded , randomized , clinical trial was conducted with 33 patients undergoing upper premolar extraction .


The patients were randomly allocated into one of three groups , according to the local anesthetic agent used : 2 % lidocaine , 2 % mepivacaine , or 4 % articaine , all with 1:100000 epinephrine , and were blinded to the anesthetic used .


The extent of anesthetization , pulpal anesthetization in adjacent teeth , pain on injection , and adverse effects of the anesthetic agents were assessed .


The extent of anesthetization produced by 4 % articaine ( 42mm ) was statistically more significant ( P0 .05 ) than 2 % lidocaine ( 33mm ) and 2 % mepivacaine ( 32.5 mm ) .


The successful anesthetization of adjacent teeth occurred more often in the articaine group than in the lidocaine and mepivacine groups , although not to a statistically-significant extent .


The pain scores for the injections were comparable between the three groups .


Local anesthetization using 4 % articaine with 1:100000 epinephrine covers a wider area of soft tissue and adjacent teeth than 2 % lidocaine or 2 % mepivacaine with 1:100000 epinephrine , which is sufficient for the extraction of one or two teeth .


To investigate the role of 1,25-dihydroxyvitamin D3 in the posterior transforaminal lumbar interbody fusion ( TLIF ) for patients with osteoporosis and lumbar degenerative disease .


Between November 20ll and October 2012 , 44 patients with osteoporosis and lumbar degenerative disease were treated with TLIF and the clinical data were retrospectively analyzed .


The patients were divided into 2 groups based on the administration of 1,25-dihydroxyvitamin D3 .


After TLIF operation , 1,25-dihydroxyvitamin D3 was used in 21 patients ( trial group ) , and was not used in 23 patients ( control group ) .


There was no significant difference in gender , age , etiology , affected segment , and disease duration between 2 groups ( P > 0.05 ) .


Lumbar interbody fusion was observed by X-ray and thin-section CT scan reconstruction of lumbar spine according to Brantigan assessment system at 6 months after operation and last follow-up .


Clinical outcome was evaluated by Oswestry disability index ( ODI ) before and after operation .


The patients of 2 groups were followed up 12-27 months ( mean , 14.5 months ) .


No fixation loosening or breaking occurred during follow-up .


ODI scores in both groups were significantly improved at 6 months after operation and last follow-up ( P < 0.05 ) when compared with preoperative value .


Although at preoperation there was no significant difference in ODI score between 2 groups ( P > 0.05 ) , ODI score of trial group was significantly lower than that of control group at 6 months after operation and last follow-up ( P < 0.05 ) .


At 6 months after operation , the interbody fusion rate was 76.19 % ( 16/21 ) in trial group and 43.48 % ( 10/23 ) in control group , showing significant difference ( 2 = 3.60 , P = 0.03 ) ; at last follow-up , the fusion rate was 95.24 % ( 20/21 ) in trial group and 65.22 % ( 15/23 ) in control group , showing significant difference ( 2 = 4.38 , P = 0.02 ) .


1,25-dihydroxyvitamin D3 can improve the lumbar interbody fusion rate and general conditions in the patients with osteoporosis and lumbar degenerative disease .


The incidence of perioperative myocardial infarction ( PMI ) globally is known to be around 2 to 3 % and can prolong hospitalization , increased morbidity and mortality .


Little is known about the pathophysiology and risk factors for PMI .


We investigate the presence of elevated novel cardiac markers and preoperative coronary artery plaque through contemporary laboratory techniques to determine the correlation with PMI , as well as studying ivabradine and atorvastatin as protective pharmacotherapies against PMI in the context of orthopedic surgery .


We aim to enroll 200 patients aged above 60 years who suffer from neck of femur fracture requiring surgery .


Patients will be randomized to four arms ( no study drugs , atorvastatin only , ivabradine only and ivabradine and atorvastatin ) .


Our primary outcome is incidence of PMI .


All patients will receive an electrocardiogram , cardiac echocardiography , measurement of novel cardiac biomarkers and computed tomography ( CT ) coronary angiography .


A telephone interview post discharge will be conducted at 30 days , 60 days and 1 year .


We postulate that ivabradine and atorvastatin will reduce the rate and magnitude of PMI following surgery by reducing heart rate and attenuating catecholamine-induced tachycardia postoperatively .


Secondly , we postulate that postoperative reduction in heart rate and catecholamine-induced tachycardia with ivabradine will correlate with a reduction in cardiovascular novel biomarkers which will reduce atrial stretch and postoperative incidence of arrhythmia .


We aim to demonstrate that treatment with ivabradine and atorvastatin will cause a reduction in the incidence and magnitude of PMI , the benefit of which is derived primarily in patients with greater atherosclerotic burden as measured by higher CT coronary calcium scores .


This study protocol has been listed in the Australia New Zealand Clinical Trial Registry ( registration number : ACTRN12612000340831 ) on 23 March 2012 .


The aim of the present study was to evaluate the natural course of acute incomplete stent apposition ( ISA ) after second-generation everolimus-eluting stent ( EES ) when compared with first-generation sirolimus-eluting stent ( SES ) by using optical coherence tomography ( OCT ) .


From the OCT substudy of the RESET trial , we identified 77 patients ( EES = 38 and SES = 39 ) who successfully underwent serial OCT examination at post-stenting and 8-12-month follow-up .


The presence of ISA was assessed in the OCT images , and ISA distance was measured from the centre of the strut blooming to the adjacent lumen border .


Incomplete stent apposition was observed in all EES and SES at post-stenting , and it was persistent in 26 % of EES and 38 % of SES at 8-12-month follow-up .


Maximum ISA distance was significantly decreased during the follow-up period in both EES ( 315 94-110 165 m , P < 0.001 ) and SES ( 308 119-143 195 m , P < 0.001 ) .


Receiver-operating curve analysis identified that the best cut-off value of OCT-estimated ISA distance at post-stenting for predicting late-persistent ISA at 8-12-month follow-up in EES and SES was > 355 and > 285 m , respectively .


The second-generation EES showed better healing of acute ISA in comparison with the first-generation SES .


Optical coherence tomography can predict late-persistent ISA after DES implantation and provide useful information to optimize PCI .


Small single-center comparative studies suggest improved outcomes in cardiac resynchronization therapy ( CRT ) patients implanted with a quadripolar left ventricular ( LV ) lead in comparison with non-quadripolar ( bipolar ) leads .


This study represents the first large multicenter prospective registry comparing implant and 6-month postoperative lead performance following CRT-defibrillator ( CRT-D ) implantation with quadripolar vs. bipolar leads .


During a 39-month period , 418 consecutive patients having CRT-D implantation attempts with either a quadripolar ( n = 230 ) or bipolar LV lead ( n = 188 ) were enrolled in the registry .


The primary outcome of the study was LV lead failure defined as any abnormality , excluding infection , resulting in surgical lead revision or CRT termination .


Additionally , operative and follow-up data were analyzed for significant difference between groups .


Baseline characteristics of both groups were similar .


In 72.9 % of quadripolar leads versus 65.0 % of bipolar leads , the LV lead successfully engaged the predefined ideal target side branch ( p = 0.47 ) .


Implant duration and fluoroscopy times were significantly shorter when a quadripolar lead was used ( p = 0.007 and p = 0.001 , respectively ) .


The primary end point occurred in six patients ( 2.7 % ) in the quadripolar group and in 14 patients ( 8.0 % ) in the bipolar group ( p = 0.02 ) .


Clinically significant phrenic nerve stimulation ( PNS ) occurred in 4.6 vs. 14.2 % of quadripolar vs. bipolar patients , respectively ( p = 0.002 ) ; all PNS were resolved noninvasively through programming in the quadripolar group vs. 84 % in bipolar group ( p = 0.75 ) .


The use of a bipolar lead was associated with a higher risk of surgical LV lead revision ( 6.3 vs. 2.3 % ; p = 0.057 ) and a higher incidence of dislodgment ( 5.7 vs. 2.7 % ; p = 0.16 ) .


This multicenter study demonstrates that the use of a quadripolar LV lead results in significantly lower rates of lead-related problems and reduced procedural and fluoroscopic times for biventricular system implantation .


This has important implications for LV pacing lead choice .


Rapid sputum culture conversion at 2 months indicates the sterilizing capacity and potential of regimens to shorten duration of tuberculosis treatment .


We compared results of sputum culture conversion by moxifloxacin and control regimens and identified factors affecting sputum culture positivity after 2 months of treatment .


Human immunodeficiency virus-uninfected adults with newly diagnosed smear-positive pulmonary tuberculosis were randomized to receive a 3 - or 4-month moxifloxacin regimen ( moxifloxacin [ M ] , isoniazid [ H ] , rifampicin [ R ] , pyrazinamide [ Z ] , ethambutol [ E ] ) or the control regimen ( RHZE thrice weekly ) .


Bacteriological assessments were done at 15 , 30 , 45 , and 60 days of treatment .


Because all patients in the moxifloxacin groups received 2 months of daily RHZEM , they were grouped together for analysis .


Statistical methods included ( 2 ) test and logistic regression analysis .


Sputum culture conversion was analyzed in 780 ( 616 in the moxifloxacin group and 164 in the control group ) of 801 enrolled patients .


Ninety-five percent of 590 patients in the moxifloxacin group and 81 % of 151 patients in the control group had negative sputum cultures at month 2 ( P < .001 ) .


The control regimen , age ( 35 years ) , initial sputum culture grade ( 2 + or 3 + ) , and male sex were significantly associated with higher odds of positive sputum cultures at 2 months .


A 5-drug daily regimen with moxifloxacin results in significantly higher sputum culture conversion in the first 2 months compared with a thrice-weekly , 4-drug regimen in patients with newly diagnosed sputum-positive pulmonary tuberculosis .


Randomized clinical trial .


To compare the effectiveness of the Alfredson eccentric heel-drop protocol with a `` do-as-tolerated '' protocol for nonathletic individuals with midportion Achilles tendinopathy .


The Alfredson protocol recommends the completion of 180 eccentric heel drops a day .


However , completing this large number of repetitions is time consuming and potentially uncomfortable .


There is a need to investigate varying exercise dosages that minimize the discomfort yet retain the clinical benefits .


Twenty-eight individuals from outpatient physiotherapy departments were randomized to either the standard ( n = 15 ) or the do-as-tolerated ( n = 13 ) 6-week intervention protocol .


Apart from repetition volume , all other aspects of management were standardized between groups .


Tendinopathy clinical severity was assessed with the Victorian Institute of Sport Assessment-Achilles ( VISA-A ) questionnaire .


Pain intensity was assessed using a visual analog scale ( VAS ) .


Both were assessed at baseline , 3 weeks , and 6 weeks .


Treatment satisfaction was assessed at week 6 .


Adverse effects were also monitored .


There was a statistically significant within-group improvement in VISA-A score for both groups ( standard , P = .03 ; do as tolerated , P < .001 ) and VAS pain for the do-as-tolerated group ( P = .001 ) at week 6 , based on the intention-to-treat analysis .


There was a statistically significant between-group difference in VISA-A scores at week 3 , based on both the intention-to-treat ( P = .004 ) and per-protocol analyses ( P = .007 ) , partly due to a within-group deterioration at week 3 in the standard group .


There were no statistically significant between-group differences for VISA-A and VAS pain scores at week 6 , the completion of the intervention .


There was no significant association between satisfaction and treatment groups at week 6 .


No adverse effects were reported .


Performing a 6-week do-as-tolerated program of eccentric heel-drop exercises , compared to the recommended 180 repetitions per day , did not lead to lesser improvement for individuals with midportion Achilles tendinopathy , based on VISA-A and VAS scores .