It remains to be tested in a long-term study if a beneficial effect on the glucose response of the isolated arabinoxylan will be related to the SCFA production .


Fibre-rich rye products have been shown to have superior effects on self-reported appetite compared to white wheat bread and some studies have shown lower energy intake after subsequent meal .


The aim of the present study was to evaluate the effects of whole grain rye crisp bread ( RB ) versus refined wheat bread ( WB ) on appetite in two studies using different portion sizes and total energy intakes .


Two randomised cross-over pre-load studies were conducted in 20 and 21 subjects , respectively .


Appetite was rated by visual analogue scale ( VAS ) for 4 h.


In both studies , participants were 39 14 years old and had BMI 23 3 .


The studies differed in terms of energy content of the breakfasts and proportion of energy from the treatment product as well as amount of test products .


Differences between treatments within the two studies were evaluated using mixed models with repeated measures appropriate for cross-over designs .


In Study one , hunger and desire to eat were significantly lower ( P < 0.05 ) after RB compared with WB , but there were no difference for fullness or difference in energy intake at lunch served ad libitum .


In Study two , the portion size was lower than in Study one and the test product constituted a larger proportion of the breakfast .


Fullness was significantly higher after RB compared with WB ( P < 0.05 ) and hunger , desire to eat as well as energy intake at lunch were significantly lower ( P < 0.05 ) .


Whole grain rye crisp bread caused lower self-reported hunger , higher fullness and less desire to eat compared to refined wheat bread .


It also led to a lower energy intake after an ad libitum lunch .


Results were stronger and/or more consistent when the test meal portion was smaller and accounted for a larger proportion of the total energy intake of the breakfast .


To determine the occurrence of extremely low HDL cholesterol ( HDL-C ) among participants in the Action to Control Cardiovascular Risk in Diabetes ( ACCORD ) Lipid Trial and to examine the relationship of this finding with treatment with fenofibrate and thiazolidinedione ( TZD ) .


The ACCORD Lipid Trial was a randomized , double-blind , placebo-controlled study conducted in patients with type 2 diabetes at 77 clinical centers across the U.S. and Canada in a 5,518-patient subset of the larger 10,251 ACCORD Glycemia Trial .


Patients were enrolled from 11 January 2001 to 29 October 2005 and followed until the end of study visits between 1 March and 30 June 2009 .


Follow-up in the ACCORD Lipid Trial was 4-8 years ( mean 4.7 years ) .


Patients were treated with blinded fenofibrate or placebo on a background of simvastatin therapy .


The main outcome measures for these descriptive , post hoc analyses was the occurrence of extremely low HDL-C ( defined as < 25 mg/dL [ 0.647 mmol/L ] ) during the trial .


Among ACCORD Lipid Trial participants , the occurrence of extremely low HDL-C ever during study follow-up was 106 % higher among those randomized to fenofibrate ( 10.1 % fenofibrate vs. 4.9 % placebo , P < 0.001 ) .


The occurrence of low HDL-C was associated with concurrent treatment with fenofibrate and TZD ( 7.0 % for both vs. 2.2 % for neither at 48 months postrandomization ) .


Idiosyncratic and marked reduction in HDL-C can occur in some patients treated with both fenofibrate and TZD .


Practitioners should recognize this important potential idiosyncratic reaction and take appropriate corrective action .


Osteoarthritis affecting the first metatarsophalangeal joint of the foot is a common condition which results in pain , stiffness and impaired ambulation .


Footwear modifications and foot orthoses are widely used in clinical practice to treat this condition , but their effectiveness has not been rigorously evaluated .


This article describes the design of a randomised trial comparing the effectiveness of rocker-sole footwear and individualised prefabricated foot orthoses in reducing pain associated with first metatarsophalangeal joint osteoarthritis .


Eighty people with first metatarsophalangeal joint osteoarthritis will be randomly allocated to receive either a pair of rocker-sole shoes ( MBT Matwa , Masai Barefoot Technology , Switzerland ) or a pair of individualised , prefabricated foot orthoses ( Vasyli Customs , Vasyli Medical , Queensland , Australia ) .


At baseline , the biomechanical effects of the interventions will be examined using a wireless wearable sensor motion analysis system ( LEGSys , BioSensics , Boston , MA , USA ) and an in-shoe plantar pressure system ( Pedar , Novel GmbH , Munich , Germany ) .


The primary outcome measure will be the pain subscale of the Foot Health Status Questionnaire ( FHSQ ) , measured at baseline and 4 , 8 and 12 weeks .


Secondary outcome measures will include the function , footwear and general foot health subscales of the FHSQ , severity of pain and stiffness at the first metatarsophalangeal joint ( measured using 100 mm visual analog scales ) , global change in symptoms ( using a 15-point Likert scale ) , health status ( using the Short-Form-12 Version 2.0 questionnaire ) , use of rescue medication and co-interventions to relieve pain , the frequency and type of self-reported adverse events and physical activity levels ( using the Incidental and Planned Activity Questionnaire ) .


Data will be analysed using the intention to treat principle .


This study is the first randomised trial to compare the effectiveness of rocker-sole footwear and individualised prefabricated foot orthoses in reducing pain associated with osteoarthritis of the first metatarsophalangeal joint , and only the third randomised trial ever conducted for this condition .


The study has been pragmatically designed to ensure that the findings can be implemented into clinical practice if the interventions are found to be effective , and the baseline biomechanical analysis will provide useful insights into their mechanism of action .


Australian New Zealand Clinical Trials Registry : ACTRN12613001245785 .


To analyze the impact of a home exercise training ( ET ) program on quality of life , motor activity ( MA ) , dietary habit , functional and biochemical parameters , and clinical course of the disease in patients who have experienced acute coronary syndrome ( ACS ) and/or endovascular coronary intervention ( ECI ) .


The trial included 100 patients after ECL who were randomized into 2 groups : those who had gone through Patient School ( PS ) and received a 6-week course of controlled ET ( a study group ( Group S ) ) and those who had gone through PS only ( a control group ( Group C ) .


The patients of both groups were recommended a home ET program and , according to its implementation , they formed 2 subgroups : Subgroup A ( home ET + ) comprising 51 patients who had trained themselves at home ) and Subgroup B ( home ET - ) consisting of 46 patients who had not .


The follow-up lasted 1 year .


Quality of life , risk factors , lifestyle and clinical parameters were assessed .


As time elapsed , the patients ' motivation to perform home ET ; and , accordingly , the proportion of those who had trained themselves decreased in Group S to 67 and 61 % and in Group C to 39 and 40 % after 6 and 12 months , respectively .


Among the reasons for refusal to perform home ET , disease was reported by only 5.6 % of the patients ( by all from Group C ) .


The comprehensive physical rehabilitation program ( RP ) ( controlled ET in combination with home ET ) produced the best effect in raising the level of daily MA , exercise performance with a 21.3-fold increase in cardiac performance ( p < 0.05 ) and a 14.3-fold decrease in heart rate increment in response to exercises .


Group C patients who had refused the home ET program , as compared to those in the same group who had trained themselves at home , showed the worst daily MA levels , none body mass index reduction , and a rise in the low-density lipoprotein cholesterol ( by 20.3 % ; p < 0.05 ) and in the number of angina attacks ( by 1.9 times ; p < 0.05 ) .


RP in the early-stage , which encompasses an educational program ( PS ) , a short-term course of controlled ET and home ET used in patients with ACS , including in those after ECI , has clear clinical benefits .


The participation of patients with coronary heart disease ( CHD ) in the home ET programs increases their motivation and , hence , the proportion of those who participate in therapeutic and rehabilitation measures .


Home patient physical rehabilitation is one of the important components of different rehabilitation and prevention programs in patients with CHD after ACS and ECI .


Budesonide is a high-potency , second-generation corticosteroid designed to minimize systemic adverse consequences of conventional corticosteroids .


We performed 2 randomized , phase 3 trials to evaluate the ability of budesonide rectal foam , formulated to optimize retention and provide uniform delivery of budesonide to the rectum and distal colon , to induce remission in patients with ulcerative proctitis or ulcerative proctosigmoiditis .


Two identically designed , randomized , double-blind , placebo-controlled trials evaluated the efficacy of budesonide foam for induction of remission in 546 patients with mild to moderate ulcerative proctitis or ulcerative proctosigmoiditis who received budesonide foam 2 mg/25 mL twice daily for 2 weeks , then once daily for 4 weeks , or placebo .


Remission at week 6 occurred significantly more frequently among patients receiving budesonide foam than placebo ( Study 1 : 38.3 % vs 25.8 % ; P = .0324 ; Study 2 : 44.0 % vs 22.4 % ; P < .0001 ) .


A significantly greater percentage of patients receiving budesonide foam vs placebo achieved rectal bleeding resolution ( Study 1 : 46.6 % vs 28.0 % ; P = .0022 ; Study 2 : 50.0 % vs 28.6 % ; P = .0002 ) and endoscopic improvement ( Study 1 : 55.6 % vs 43.2 % ; P = .0486 ; Study 2 : 56.0 % vs 36.7 % ; P = .0013 ) at week 6 .


Most adverse events occurred at similar frequencies between groups , although events related to changes in cortisol values were reported more frequently with budesonide foam .


There were no cases of clinically symptomatic adrenal insufficiency .


Budesonide rectal foam was well tolerated and more efficacious than placebo in inducing remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis .


ClinicalTrials.gov ID : NCT01008410 and NCT01008423 .


Flexible cystoscopy is a common practice in urology .


We wanted to determine whether a retention time of 5 minutes between the administration of a local anesthetic lubricant and flexible cystoscope insertion decreased the degree of discomfort or pain in the patient .


Males who underwent flexible cystoscopy during 5 months were randomized in a prospective study .


They were divided into two groups .


In the first one , the Cathejell lubricant with lidocaine 12.5 g was administered and cystoscopy was performed immediately .


In the second one , the same lubricant was maintained in the urethra for 5 minutes before the performance of cystoscopy .


After scanning , all the patients were requested to indicate the degree of perceived pain on a visual pain scale from 0 to 10 , with 0 being no discomfort and 10 being the maximum degree of pain bearable .


As a secondary objective , the relationship of pain to age and to the type of cystoscopist ( urologist/resident doctor ) was studied .


For statistical analysis , a Student 's t-test for independent samples and correlation analysis were used .


A total of 242 patients were studied , 110 in the immediate group and 132 in the 5-minute delay group , with samples being homogeneous for the age and type of cystoscopist .


The mean in the pain scale in the immediate group was 2.41 , and in the 5-minute delay group was 2.04 , with no significant differences between them ( p = 0.175 ) .


There was no relationship with age ( r = -0.061 , p = 0.348 ) or with the type of cystoscopist ( 2.06 of average pain in the associate group , 2.35 in the resident , p = 0.28 ) .


There is no benefit in waiting a short time after the administration of intraurethral lubrication with a local anesthetic in flexible cystoscopy in men .


There is also no relationship between the patient age or the type of cystoscopist ( urologist/resident doctor ) and perceived pain .


Bariatric patients seeking information meet very different recommendations on postoperative diet and eating behaviour .


A reason for variability may be lack of hard evidence .


A national survey on current dietary advice was conducted to serve as background for the present study on how drinking during a meal influenced caloric consumption .


A standardised questionnaire was sent to all units in the Scandinavian Obesity surgery registry ( SOReg ) in order to obtain information regarding current diet advice after gastric bypass .


Twenty-eight patients , 14 in each group , were studied either 2 months or 1 year after a standard gastric bypass ( GBP ) .


A standardised lunch was served on two separate days with or without water in randomised order .


Meal and water weights were measured before and after .


Hunger/satiety scores were obtained using visual analogue scales .


Response rate for surgeons was low , for dieticians 75 % .


No clear consensus for liquid intake during meals was found ; few surgeons advised patients whether or not to drink with meals .


All patients ate to full satiety .


Two months post-GBP , 7/14 patients consumed more solid food when allowed drinking water ; the increase in caloric consumption was not significant .


One year post-GBP , 5/14 patients consumed more solid food when allowed drinking water , the difference not reaching statistical significance .


Our study does not indicate that patients should refrain from drinking during meals the first year after a GBP , at least not from a caloric intake point of view .


Ultrasound-guided nerve blocks ( UGNB ) are increasingly used in emergency care .


The hand-on-syringe ( HS ) needle technique is ideally suited to the emergency department setting because it allows a single operator to perform the block without assistance .


The HS technique is assumed to provide less exact needle control than the alternative two-operator hand-on-needle ( HN ) technique ; however this assumption has never been directly tested .


The primary objective of this study was to compare accuracy of needle targeting under ultrasound guidance by emergency medicine ( EM ) residents using HN and HS techniques on a standardized gelatinous simulation model .


This prospective , randomized study evaluated task performance .


We compared needle targeting accuracy using the HN and HS techniques .


Each participant performed a set of structured needling maneuvers ( both simple and difficult ) on a standardized partial-task simulator .


We evaluated time to task completion , needle visualization during advancement , and accuracy of needle tip at targeting .


Resident technique preference was assessed using a post-task survey .


We evaluated 60 tasks performed by 10 EM residents .


There was no significant difference in time to complete the simple model ( HN vs. HS , 18 seconds vs. 18 seconds , p = 0.93 ) , time to complete the difficult model ( HN vs. HS , 56 seconds vs. 50 seconds , p = 0.63 ) , needle visualization , or needle tip targeting accuracy .


Most residents ( 60 % ) preferred the HS technique .


For EM residents learning UGNBs , the HN technique was not associated with superior needle control .


Our results suggest that the single-operator HS technique provides equivalent needle control when compared to the two-operator HN technique .


For women at risk of HIV-1 , effective contraception and effective HIV-1 prevention are global priorities .


In a clinical trial of pre-exposure prophylaxis ( PrEP ) for HIV-1 prevention in HIV-1-serodiscordant couples , we estimated the effectiveness of hormonal contraceptives ( oral contraceptive pills , injectable depot medroxyprogesterone acetate , and hormonal implants ) for pregnancy prevention relative to no contraception among 1785 HIV-1-uninfected women followed up to 36 months .


We compared the effectiveness of each method among women assigned PrEP versus placebo .


Contraception was not required for participation , but was offered on-site and was recorded monthly ; incident pregnancy was determined by monthly urine testing .


For women using no contraception , overall pregnancy incidence was 15.4 % per year .


Women reporting oral contraceptive use had comparable pregnancy incidence to women using no contraception , and this lack of contraceptive effectiveness was similar for those assigned PrEP and placebo ( 17.7 and 10.0 % incidence per year , respectively ; P-value for difference in effect by PrEP use = 0.24 ) .


Women reporting injectable contraception had reduced pregnancy incidence compared to those reporting no contraception , which did not differ by arm ( PrEP 5.1 % , placebo 5.3 % per year ; P-value for difference = 0.47 ) .


Contraceptive effectiveness was highest among women using implants ( pregnancy incidence < 1 % per year in both arms ) .


PrEP had no adverse impact on hormonal contraceptive effectiveness for pregnancy prevention .


As seen previously in similar populations , women reporting contraceptive pill use had little protection from pregnancy , possibly due to poor adherence .


Injectable or implantable hormonal contraception and PrEP provide effective prevention for pregnancy and HIV-1 .


To investigate acute hypervolemic hemodilution effect on oxygen metabolism and blood pharmacokinetics in patients undergoing acute laparotomy during Induction of general anesthesia .


Forty ASA I-II patients undergoing acute laparotomy were randomly divided into 2 groups ( n = 20 each ) : Patients of group A received Voluven 7 ml/kg in 20 mins before induction and 8 ml/kg after induction .


Patients of group B received 6 ml/kg/h Plasmalyte A. Hemodynamic parameters MAP , HR and CVP were collected at 6 set points during the surgery : T1 : before AHH ; T2 : before anesthesia induction ; T3 : right intubation ; T4 : 10 min after intubation ; T5 : 20 min after intubation ; T6 : skin incision .


Arterial and venous blood samples were taken for blood gas analysis and determination of lactic acid , Hb and Hct : T1 : before AHH , T2 : right after AHH , T3 : 0.5 h after AHH , T4 : l h after AHH .


Arterial Oxygen Content ( Ca02 ) , Central Venous Oxygen Content ( Ccv02 ) and Oxygen Extraction Ratio ( ER02 ) were calculated .


The hemodynamic parameters were maintained within normal limits during operation in group A ( P < 0.05 ) .


CaO2 , CcvO2 , ERO2 and Lac between the two groups were no significant difference ( P > 0.05 ) .


Compared with T1 , CaO2/CcvO2 atT 2 ~ 4 reduced in both groups ( P < 0.05 ) .


Compared with group A , Hb and Hct in group B increased at T2 ~ 4 ( P < 0.05 ) .


Acute hypervolemic hemodilution in patients undergoing acute laparotomy during Induction of general anesthesia have some preventive hypotension effect , more conducive to the smooth blood pharmacokinetics ; Voluven induced expansion of applications is safe and effective , and has no effect on the body 's metabolic rate of oxygen .


To compare in a randomized controlled clinical trial ( RCT ) the application of the TheraBite ( TB ) Jaw Motion Rehabilitation System with a standard physical therapy ( PT ) exercise regimen for the treatment of myogenic temporomandibular disorder ( TMD ) .


Myogenic TMD patients were randomized for the use of the TB device or for standard PT .


Mandibular function was assessed with the mandibular function impairment questionnaire ( MFIQ ) .


Pain was evaluated using a visual analog scale , and maximum inter-incisor ( mouth ) opening ( MIO ) was measured using the disposable TB range of motion scale .


Of the 96 patients randomized ( 46 TB , 50 standard PT exercises ) , 38 actually started with the TB device and 41 with the standard PT exercises .


After six-week follow-up , patients using the TB device reported a significantly greater functional improvement ( MFIQ score ) than the patients receiving regular PT exercises ( P = 0.0050 ) .


At 6 weeks , no significant differences in pain , and active or passive MIO were found between the two groups .


At 3 months , patients in both treatment groups did equally well , and showed a significant improvement in all parameters assessed .


This RCT on myogenic TMD treatment , comparing standard PT with passive jaw mobilization using the TheraBite Jaw Motion Rehabilitation System , shows that both treatment modalities are equally effective in relieving myogenic TMD symptoms , but that the use of the TB device has the benefit of achieving a significantly greater functional improvement within the first week of treatment .


Efforts are needed to improve informed consent of participants in research .


The Strategic Timing of AntiRetroviral Therapy ( START ) study provides a unique opportunity to study the effect of length and complexity of informed consent documents on understanding and satisfaction among geographically diverse participants .


Interested START sites were randomized to use either the standard consent form or the concise consent form for all of the site 's participants .


A total of 4473 HIV-positive participants at 154 sites world-wide took part in the Informed Consent Substudy , with consent given in 11 primary languages .


Most sites sent written information to potential participants in advance of clinic visits , usually including the consent form .


At about half the sites , staff reported spending less than an hour per participant in the consent process .


The vast majority of sites assessed participant understanding using informal nonspecific questions or clinical judgment .


These data reflect the interest of START research staff in evaluating the consent process and improving informed consent .


The START Informed Consent Substudy is by far the largest study of informed consent intervention ever conducted .


Its results have the potential to impact how consent forms are written around the world .


To evaluate the effect of different methods to convert magnetic resonance ( MR ) signal intensity ( SI ) to gadolinium concentration ( [ Gd ] ) on estimation and reproducibility of model-free and modeled hepatic perfusion parameters measured with dynamic contrast-enhanced ( DCE ) - MRI .


In this Institutional Review Board ( IRB ) - approved prospective study , 23 DCE-MRI examinations of the liver were performed on 17 patients .


SI was converted to [ Gd ] using linearity vs. nonlinearity assumptions ( using spoiled gradient recalled echo [ SPGR ] signal equations ) .


The [ Gd ] vs. time curves were analyzed using model-free parameters and a dual-input single compartment model .


Perfusion parameters obtained with the two conversion methods were compared using paired Wilcoxon test .


Test-retest and interobserver reproducibility of perfusion parameters were assessed in six patients .


There were significant differences between the two conversion methods for the following parameters : AUC60 ( area under the curve at 60 s , P < 0.001 ) , peak gadolinium concentration ( Cpeak , P < 0.001 ) , upslope ( P < 0.001 ) , Fp ( portal flow , P = 0.04 ) , total hepatic flow ( Ft , P = 0.007 ) , and MTT ( mean transit time , P < 0.001 ) .


Our preliminary results showed acceptable to good reproducibility for all model-free parameters for both methods ( mean coefficient of variation [ CV ] range , 11.87-23 .7 % ) , except for upslope ( CV = 37 % ) .


Among modeled parameters , DV ( distribution volume ) had CV < 22 % with both methods , PV and MTT showed CV < 21 % and < 29 % using SPGR equations , respectively .


Other modeled parameters had CV > 30 % with both methods .


Linearity assumption is acceptable for quantification of model-free hepatic perfusion parameters while the use of SPGR equations and T1 mapping may be recommended for the quantification of modeled hepatic perfusion parameters .


The effectiveness of two treatment approaches ( phonological therapy and articulation therapy ) for treatment of 14 children , aged 4 ; 0-6 ; 7 years , with phonologically based speech-sound disorder ( SSD ) has been previously analysed with severity outcome measures ( percentage of consonants correct score , percentage occurrence of phonological processes and phonetic inventory ) .


Considering that the ultimate goal of intervention for children with phonologically based SSD is to improve intelligibility , it is curious that intervention studies focusing on children 's phonology do not routinely use intelligibility as an outcome measure .


It is therefore important that the impact of interventions on speech intelligibility is explored .


This paper investigates the effectiveness of the two treatment approaches ( phonological therapy and articulation therapy ) using intelligibility measures , both in single words and in continuous speech , as the primary outcome .


Fourteen children with phonologically based SSD participated in the intervention .


The children were randomly assigned to phonological therapy or articulation therapy ( seven children in each group ) .


Two assessment methods were used for measuring intelligibility : a word identification task ( for single words ) and a rating scale ( for continuous speech ) .


Twenty-one unfamiliar adults listened and judged the children 's intelligibility .


Reliability analyses showed overall high agreement between listeners across both methods .


Significant improvements were noted in intelligibility in both single words ( paired t ( 6 ) = 4.409 , p = 0.005 ) and continuous speech ( asymptotic Z = 2.371 , p = 0.018 ) for the group receiving phonology therapy pre - to post-treatment , but no differences in intelligibility were found for those receiving the articulation therapy pre - to post-treatment , either for single words ( paired t ( 6 ) = 1.763 , p = 0.128 ) or continuous speech ( asymptotic Z = 1.442 , p = 0.149 ) .


Intelligibility measures were sensitive enough to show changes in the phonological therapy group but not in the articulation therapy group .


These findings emphasize the importance of using intelligibility as an outcome measure to complement the results obtained with other severity measures when exploring the effectiveness of speech interventions .


This study presents new evidence for the effectiveness of phonological therapy in improving intelligibility with children with SSD .


Staphylococcus aureus bacteremia is a common infection associated with significant morbidity and mortality .


Telavancin is a bactericidal lipoglycopeptide active against Gram-positive pathogens , including methicillin-resistant S. aureus ( MRSA ) .


We conducted a randomized , double-blind , Phase 2 trial in patients with uncomplicated S. aureus bacteremia .


Patients were randomized to either telavancin or standard therapy ( vancomycin or anti-staphylococcal penicillin ) for 14days .


Continuation criteria were set to avoid complicated S. aureus bacteremia .


The primary end point was clinical cure at 84days .


In total , 60 patients were randomized and 58 received 1 study medication dose ( all-treated ) , 31 patients fulfilled inclusion/exclusion and continuation criteria ( all-treated target [ ATT ] ) ( telavancin 15 , standard therapy 16 ) , and 17 patients were clinically evaluable ( CE ) ( telavancin 8 , standard therapy 9 ) .


Mean age ( ATT ) was 60years .


Intravenous catheters were the most common source of S. aureus bacteremia and ~ 50 % of patients had MRSA .


A similar proportion of CE patients were cured in the telavancin ( 88 % ) and standard therapy ( 89 % ) groups .


All patients with MRSA bacteremia were cured and one patient with MSSA bacteremia failed study treatment in each group .


Although adverse events ( AEs ) were more common in the telavancin ATT group ( 90 % vs. 72 % ) , AEs leading to drug discontinuation were similar ( 7 % ) in both treatment arms .


Potentially clinically significant increases in serum creatinine ( 1.5 mg/dl and at least 50 % greater than baseline ) were more common in the telavancin group ( 20 % vs. 7 % ) .


This study suggests that telavancin may have utility for treatment of uncomplicated S. aureus bacteremia ; additional studies are warranted .


( Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia ( ASSURE ) ; NCT00062647 ) .


To evaluate the effectiveness of sulodexide for the treatment of hard exudates ( HE ) in non-proliferative diabetic retinopathy ( NPDR ) .


This was a randomized , placebo-controlled , multicenter trial involving 130 patients ( 65 for each group ) who had mild-to-moderate NPDR with macular HE .


Participants were given a daily dose of either 50 mg sulodexide or a matching dose of placebo orally for 12 months .


Main outcome measure was an improvement in HE defined as a decrease in severity by at least two grades on a 10-grade severity scale .


This was evaluated by fundus photography over 12-month period .


The sulodexide group showed significantly greater improvement in HE severity than that shown by the placebo group ( 39.0 % vs. 19.3 % ; chi square , P = 0.005 ) .


Logistic regression analysis yielded an odds ratio of 2.790 ( 95 % confidence interval , 1.155-6 .743 ; P = 0.023 ) for the effect of treatment once adjustments were made for demographic , prognostic and disease confounders .


Intention to treat and per-protocol analysis yielded similar results .


Sulodexide 's safety was comparable to that of the placebo .


Oral sulodexide therapy over 12 months improved macular HE in patients with mild-to-moderate NPDR , without leading to detectable adverse events .


The study protocol was registered on clinicaltrial.gov under identifier NCT01295775 .


Mineralocorticoid-receptor antagonists improve the prognosis for patients with heart failure and a reduced left ventricular ejection fraction .


We evaluated the effects of spironolactone in patients with heart failure and a preserved left ventricular ejection fraction .


In this randomized , double-blind trial , we assigned 3445 patients with symptomatic heart failure and a left ventricular ejection fraction of 45 % or more to receive either spironolactone ( 15 to 45 mg daily ) or placebo .


The primary outcome was a composite of death from cardiovascular causes , aborted cardiac arrest , or hospitalization for the management of heart failure .


With a mean follow-up of 3.3 years , the primary outcome occurred in 320 of 1722 patients in the spironolactone group ( 18.6 % ) and 351 of 1723 patients in the placebo group ( 20.4 % ) ( hazard ratio , 0.89 ; 95 % confidence interval [ CI ] , 0.77 to 1.04 ; P = 0.14 ) .


Of the components of the primary outcome , only hospitalization for heart failure had a significantly lower incidence in the spironolactone group than in the placebo group ( 206 patients [ 12.0 % ] vs. 245 patients [ 14.2 % ] ; hazard ratio , 0.83 ; 95 % CI , 0.69 to 0.99 , P = 0.04 ) .


Neither total deaths nor hospitalizations for any reason were significantly reduced by spironolactone .


Treatment with spironolactone was associated with increased serum creatinine levels and a doubling of the rate of hyperkalemia ( 18.7 % , vs. 9.1 % in the placebo group ) but reduced hypokalemia .


With frequent monitoring , there were no significant differences in the incidence of serious adverse events , a serum creatinine level of 3.0 mg per deciliter ( 265 mol per liter ) or higher , or dialysis .


In patients with heart failure and a preserved ejection fraction , treatment with spironolactone did not significantly reduce the incidence of the primary composite outcome of death from cardiovascular causes , aborted cardiac arrest , or hospitalization for the management of heart failure .


( Funded by the National Heart , Lung , and Blood Institute ; TOPCAT ClinicalTrials.gov number , NCT00094302 . )


To compare the effectiveness and safety of fentanyl with placebo as pre-emptive treatment for pain associated with turning in patients in intensive care units .


Turning is frequently a painful procedure in this setting .


Pre-emptive administration of supplementary analgesia may help decrease this pain .


However , medical literature on pre-emptive analgesia in these patients is scarce .


A randomized , double-blind , controlled clinical trial .


This study will assess the benefits and risks of pre-emptive analgesia with fentanyl compared with placebo on turning-associated pain .


Eighty patients will be recruited from among those older than 18 years and needing mechanical ventilation for at least 24 hours .


Pain intensity will be assessed using the Behavioral Pain Scale .


Primary outcome will be pain intensity between the baseline and 30 minutes after turning , measured by the area under the curve of the pain scale scores .


Secondary outcomes will be the usefulness of physiological parameters and the Bispectral Index to measure pain and the safety of pre-emptive fentanyl in turning .


The study protocol was approved in February 2011 .


If pre-emptive fentanyl is more effective than placebo and reasonably safe , the results of the current study may change nursing attitude in managing turning in critically ill patients .


As a consequence , pain may be decreased during this nursing procedure .


To study the associations of baseline gamma-glutamyltransferase ( GGT ) and alanine transaminase ( ALT ) with incident diabetes among Asian Indian men with impaired glucose tolerance ( IGT ) .


In a 2 year prospective , randomised , controlled primary prevention study of diabetes , among 537 IGT men aged 35-55 years , 123 incident diabetes ( DM ) cases occurred .


Anthropometric { body mass index ( BMI ) , waist circumference ( WC ) } , and laboratory measurements ( fasting , 30 min and 2 hr plasma glucose ( 2 hr PG ) , HbA1c and plasma insulin , lipid profile , ALT , GGT ) were estimated at baseline ( Clinical Trial Identification No : NCT00819455 ) .


Predictive associations of baseline GGT and ALT values during the study were assessed using appropriate statistical methods .


Baseline GGT but not ALT was significantly higher in incident diabetes cases .


Mean ( 95 % CI ) GGT decreased in subjects who reverted to normal glucose tolerance ( NGT ) , whereas it increased in subjects who deteriorated to diabetes ( NGT : -3.5 ( -6.4 to -0.6 ) ; IGT :0.3 ( -3.0 to 2.4 ) ; DM :8.3 ( 3.6 to 13.0 ) UL ( -1 ) ; P < 0.0001 ) .


The risk of DM significantly increased with increasing baseline GGT after adjusting for confounders such as BMI , alcohol drinking , 2 hr PG and insulin resistance ( 2.02 [ 1.35-3 .02 ] ; P = 0.001 ) .


Receiver operating characteristic curve showed that the model comprising of baseline fasting plasma glucose ( FPG ) and GGT ( area-under-curve ( AUC ) [ 95 % CI ] : 0.668 [ 0.613-0 .722 ] ; P < 0.0001 ) was equally sensitive in identifying subjects with risk of diabetes as compared to 2 hr PG ( AUC [ 95 % CI ] : 0.670 [ 0.614-0 .725 ] ; P < 0.0001 ) and HbA1c ( AUC [ 95 % CI ] : 0.677 [ 0.619-0 .734 ] ; P < 0.0001 ) alone .


GGT was an independent predictor of incident diabetes .


Combination of GGT and FPG offers a simple and sensitive tool to identify subjects at high risk of developing diabetes .


To compare posterior capsule opacification ( PCO ) with 3 intraocular lenses ( IOLs ) 12 years postoperatively .


St. Erik Eye Hospital , Stockholm , Sweden .


Randomized clinical trial .


Patients having unilateral standard phacoemulsification were randomized to implantation of a round-edged heparin-surface-modified ( HSM ) poly ( methyl methacrylate ) ( PMMA ) IOL , a round-edged silicone IOL , or a sharp-edged hydrophobic acrylic IOL .


The neodymium : YAG ( Nd : YAG ) capsulotomy rates and timing from surgery were recorded .


Survival analysis was used to compare Nd : YAG rates .


Retroillumination images were taken to evaluate PCO .


After 12 years , there was no significant difference in the fraction or severity of PCO between the silicone IOL and acrylic IOL .


The HSM PMMA IOL had a significantly higher PCO fraction than the silicone IOL ( P < .05 ) , but not more than the acrylic IOL .


There was no difference in PCO severity between the HSM PMMA IOL and the other 2 IOLs .


The silicone IOL had higher median capsulotomy-free survival ( > 150 months ) than the acrylic IOL ( 108 months ) and the HSM PMMA IOL ( 53 months ) .


Overall survival without Nd : YAG capsulotomy did not differ between the acrylic and silicone IOLs or between the silicone and HSM PMMA IOLs ; however , overall survival was significantly better with the acrylic IOL than with the HSM PMMA IOL ( P < .001 ) .


After 12 years , there was no difference in PCO or overall survival without capsulotomy between the acrylic IOL and the silicone IOL .


The HSM PMMA IOL had a significantly higher PCO fraction than the silicone IOL and lower overall survival than the acrylic IOL .


To identify an appropriate therapeutic regimen for using aconite cake-separated moxibustion to treat diarrhea-predominant irritable bowel syndrome ( D-IBS ) .


A factorial design was employed to examine the two factors of moxibustion frequency and number of cones .


The two tested frequencies were three or six moxibustion sessions per week , and the two tested doses were one or two cones per treatment .


A total of 166 D-IBS patients were randomly divided into four treatment groups , which included each combination of the examined frequencies and doses .


The bilateral Tianshu acupoints ( ST25 ) and the Qihai acupoint ( RN6 ) were selected for aconite cake-separated moxibustion .


Each patient received two courses of treatment , and each course had a duration of 2 wk .


For each group , the scores on the Birmingham irritable bowel syndrome ( IBS ) symptom questionnaire , the IBS Quality of Life scale , the Self-Rating Depression Scale ( SDS ) , the Self-Rating Anxiety Scale ( SAS ) , the Hamilton Depression ( HAMD ) scale , and the Hamilton Anxiety ( HAMA ) scale were determined before treatment , after the first course of treatment , and after the second course of treatment .


The symptom , quality of life , SDS , SAS , HAMD , and HAMA scores of the patients in all 4 aconite cake-separated moxibustion groups were significantly lower after the first and second courses of treatment than before treatment ( P < 0.001 for all ) .


The symptom , quality of life , SDS , SAS , HAMD , and HAMA scores of the patients in all four aconite cake-separated moxibustion groups were significantly lower after the second course of treatment than after the first course of treatment ( P < 0.001 for all ) .


Between-group comparisons after the second course of treatment revealed that the symptom scores for group 1 ( 1 cone , 3 treatments/wk ) and group 3 ( 2 cones , 3 treatments/wk ) were significantly lower than that for group 2 ( 1 cone , 6 treatments/wk ) ( 5.55 5.05 vs 10.45 6.61 , P < 0.001 ; 5.65 4.00 vs 10.45 6.61 , P < 0.001 ) .


Regarding the two levels of the two examined factors for aconite cake-separated moxibustion , after the first course of treatment , the changes in HAMA scores were significantly different for the two tested moxibustion frequencies ( P = 0.011 ) , with greater changes for the `` 6 treatments/wk '' groups than for the `` 3 treatments/wk '' groups ; in addition , there were interaction effects between the number of cones and moxibustion frequency ( P = 0.028 ) .


After the second course of treatment , changes in symptom scores for the 2 tested moxibustion frequencies were significantly different ( P = 0.002 ) , with greater changes for the `` 3 treatments/wk '' groups than for the `` 6 treatments/wk '' groups .


An aconite cake-separated moxibustion treatment regimen of 3 treatments/wk and 1 cone/treatment appears to produce better therapeutic effects for D-IBS compared with the other tested regimens .


We sought to examine predictors and moderators of treatment outcomes among 488 youths ages 7-17 years ( 50 % female ; 74 % 12 years ) meeting Diagnostic and Statistical Manual of Mental Disorders ( 4th ed. , text rev. ; American Psychiatric Association , 2000 ) criteria for diagnoses of separation anxiety disorder , social phobia , or generalized anxiety disorder who were randomly assigned to receive either cognitive behavioral therapy ( CBT ) , sertraline ( SRT ) , their combination ( COMB ) , or medication management with pill placebo ( PBO ) in the Child/Adolescent Anxiety Multimodal Study ( CAMS ) .


Six classes of predictor and moderator variables ( 22 variables ) were identified from the literature and examined using continuous ( Pediatric Anxiety Ratings Scale ; PARS ) and categorical ( Clinical Global Impression Scale-Improvement ; CGI-I ) outcome measures .


Three baseline variables predicted better outcomes ( independent of treatment condition ) on the PARS , including low anxiety severity ( as measured by parents and independent evaluators ) and caregiver strain .


No baseline variables were found to predict Week 12 responder status ( CGI-I ) .


Participants ' principal diagnosis moderated treatment outcomes but only on the PARS .


No baseline variables were found to moderate treatment outcomes on Week 12 responder status ( CGI-I ) .


Overall , anxious children responded favorably to CAMS treatments .


However , having more severe and impairing anxiety , greater caregiver strain , and a principal diagnosis of social phobia were associated with less favorable outcomes .


Clinical implications of these findings are discussed .


Emerging evidence has shown that epidural anesthesia could reduce the excessive stress response after surgery , and may help to preserve the body 's defenses against tumor progression in comparison with general anesthesia in malignant patients receiving operation .


This study aims to evaluate the effect of epidural anesthesia on postoperative immune suppression in gastric cancer patients undergoing radical resection .


Seventy one gastric cancer patients receiving radical resection were randomized to combined general/epidural anesthesia ( study group ) or general anesthesia alone ( control group ) .


Natural killer cell activity and serum concentrations of protumorigenic cytokines IL-1 and IL-6 , and antitumorigenic cytokines IL-2 and IL-10 were measured before anesthesia ( T1 ) , 4h after skin incision ( T2 ) , and 24h after skin incision ( T3 ) in both groups .


In both groups , the concentrations of IL-10 , IL-6 , and IL-10 increased at T2 and T3 when compared with T1 , whereas IL-2 concentration and NK cell activity decreased at T2 and T3 .


Furthermore , the study group exhibited less suppression of NK cell activity , higher levels of IL-2 and IL-10 , and lower levels of IL-1 and IL-6 in the early stage after operation , compared with the control group .


CONCLUSIOns : Combined general/epidural anesthesia seems to helpful to maintain the body 's perioperative immune function compared to general anesthesia alone in patients with gastric cancer operation .


The aim of this study was to evaluate the effects of a telephone-based self-care intervention among urban living individuals 75 + years of age by comparing self-reported perceived health , mental health , sense of coherence , self-care ability , and self-care agency before and after the intervention .


In a randomized controlled study , 15 persons answered a questionnaire about perceived health , mental health , sense of coherence , self-care ability , and self-care agency .


In a sex - and age-matched control group ( n = 15 ) , the same questions were answered .


Data were collected before and after intervention .


An open-ended question about experiences of the intervention was included in the last questionnaire .


The intervention consisted of a first meeting with health professionals and additional five self-care telephone calls .


The control group did not receive any intervention or attention except for the questionnaires .


Descriptive statistics were used to describe the study group .


To compare the intervention group and control group on nominal and ordinal levels , the McNemar test and the Wilcoxon signed-rank test , respectively , were chosen .


Thirty individuals ( 14 females and 16 males ) participated in the study , ranging in age between 75 and 93 years .


A significant difference was obtained in the intervention group regarding mental health .


Mental health improved significantly in the intervention group ( P = 0.037 ) .


In the control group , mental health , sense of coherence , self-care ability , and self-care agency showed worse outcome results after the intervention ( 19 weeks ) .


Self-care telephone talks improved mental health significantly in our sample , and mental health focus could be understood as a possible condition for health promotion to take place .


Structured self-care telephone talks have proved to be successful and a relevant method to use in practice .


To explore and detail clinical experiences of dabigatran , a novel anticoagulant , after it became available in New Zealand in July 2011 .


A cohort of patients was recruited from Hutt Hospital and the two largest primary care practices in the Hutt Valley region .


They were included if they took at least one dose of dabigatran between July 2011 and April 2012 .


Participants undertook a questionnaire 3-12 months after starting dabigatran assessing adherence , perceived side-effects and complications .


Those presenting due to an adverse event were analysed separately .


Of 102 patients identified , 92 were recruited to this study .


At a median of 8 months , 70 % of participants were still taking dabigatran , significantly lower than in the RE-LY trial at 12 months ( P = 0.0002 ) .


The commonest reason given for discontinuation was gastrointestinal ( GI ) side-effects .


Rates of serious adverse outcomes on dabigatran therapy were relatively low .


Patients expressed polarised comments , both positive and negative , regarding their experiences of dabigatran .


A high rate of discontinuation of dabigatran , mainly due to GI symptoms , was observed .


There does not appear to be any specific predictor of dabigatran tolerance .


When prescribed according to guidelines , rates of serious adverse events associated with dabigatran appear to be low .


Peak creatine kinase ( CK ) - MB concentration is related to reperfusion success and clinical outcomes after fibrinolytic therapy for acute myocardial infarction .


However , prognostic implications of CK-MB measurements after primary percutaneous coronary intervention ( PCI ) , which provides more predictable and consistent reperfusion , are unknown .


We pooled 2,042 primary PCI-treated ST-segment elevation myocardial infarction ( STEMI ) patients from 3 trials with serial core laboratory-determined CK-MB measurements ; 1,799 patients ( 88.1 % ) who survived to 36 hours and had 4 CK-MB measurements were studied .


Cox regression modeling was performed to quantify the association between peak CK-MB concentration ( and area under the time-concentration curve [ AUC ] ) and mortality at 6 months , and death or congestive heart failure at 90 days .


The median ( 25th-75th percentiles ) peak CK-MB concentration and AUC measurement through 36 hours were 239 ( 109-429 ) ng/mL and 4,263 ( 2,081-7 ,124 ) ng / ( mL h ) , respectively .


By multivariable analysis , peak CK-MB concentration and AUC measurement were independently associated with 6-month mortality ( adjusted hazard ratio [ HR ] 1.15 , 95 % CI 1.05-1 .25 , per 100-ng/mL increase , P = .002 ; and adjusted HR 1.09 , 95 % CI 1.03-1 .14 , per 1,000-ng / [ mL h ] increase , P < .001 , respectively ) and 90-day death or congestive heart failure ( adjusted HR 1.26 , 95 % CI 1.18-1 .34 , P < .001 ; and adjusted HR 1.15 , 95 % CI 1.11-1 .19 , P < .001 , respectively ) .


Peak CK-MB concentration and AUC measurement are independent predictors of 3 - to 6-month cardiovascular outcomes in primary PCI-treated STEMI patients .


Our findings guide application of these measurements as efficacy end points in early-phase studies evaluating new therapies for STEMI .


We conducted a pilot randomized trial of telephone-delivered acceptance and commitment therapy ( ACT ) versus cognitive behavioral therapy ( CBT ) for smoking cessation .


Participants were 121 uninsured South Carolina State Quitline callers who were adult smokers ( at least 10 cigarettes/day ) and who wanted to quit within the next 30 days .


Participants were randomized to 5 sessions of either ACT or CBT telephone counseling and were offered 2 weeks of nicotine replacement therapy ( NRT ) .


ACT participants completed more calls than CBT participants ( M = 3.25 in ACT vs. 2.23 in CBT ; p = .001 ) .


Regarding satisfaction , 100 % of ACT participants reported their treatment was useful for quitting smoking ( vs. 87 % for CBT ; p = .03 ) , and 97 % of ACT participants would recommend their treatment to a friend ( vs. 83 % for CBT ; p = .06 ) .


On the primary outcome of intent-to-treat 30-day point prevalence abstinence at 6 months postrandomization , the quit rates were 31 % in ACT versus 22 % in CBT ( odds ratio [ OR ] = 1.5 , 95 % confidence interval [ CI ] = 0.7-3 .4 ) .


Among participants depressed at baseline ( n = 47 ) , the quit rates were 33 % in ACT versus 13 % in CBT ( OR = 1.2 , 95 % CI = 1.0-1 .6 ) .


Consistent with ACT 's theory , among participants scoring low on acceptance of cravings at baseline ( n = 57 ) , the quit rates were 37 % in ACT versus 10 % in CBT ( OR = 5.3 , 95 % CI = 1.3-22 .0 ) .


ACT is feasible to deliver by phone , is highly acceptable to quitline callers , and shows highly promising quit rates compared with standard CBT quitline counseling .


As results were limited by the pilot design ( e.g. , small sample ) , a full-scale efficacy trial is now needed .


In patients with severe aortic stenosis , transcatheter aortic valve replacement ( TAVR ) improves survival when compared with nonsurgical therapy but with higher in-hospital and lifetime costs .


Complications associated with TAVR may decrease with greater experience and improved devices , thereby reducing the overall cost of the procedure .


Therefore , we sought to estimate the effect of periprocedural complications on in-hospital costs and length of stay of TAVR .


Using detailed cost data from 406 TAVR patients enrolled in the Placement of Aortic Transcatheter Valve ( PARTNER ) I trial , we developed multivariable models to estimate the incremental cost and length of stay associated with specific periprocedural complications .


Attributable costs and length of stay for each complication were calculated by multiplying the independent cost of each event by its frequency in the treatment group .


Mean cost for the initial hospitalization was $ 79 61940 570 ( $ 50 891 excluding the valve ) ; 49 % of patients had 1 complication .


Seven complications were independently associated with increased hospital costs , with major bleeding , arrhythmia , and death accounting for the largest attributable cost per patient .


Renal failure and the need for repeat TAVR , although less frequent , were also associated with substantial incremental and attributable costs .


Overall , complications accounted for $ 12 475 per patient in initial hospital costs and 2.4 days of hospitalization .


In the PARTNER trial , periprocedural complications were frequent , costly , and accounted for 25 % of non-implant-related hospital costs .


Avoidance of complications should improve the cost-effectiveness of TAVR for inoperable and high-risk patients , but reductions in the cost of uncomplicated TAVR will also be necessary for optimal efficiency .


http://www.clinicaltrials.gov .


Unique identifier : NCT00530894 .


In a recent study one third of Lao patients presenting with uncomplicated Plasmodium falciparum malaria had biochemical evidence of thiamin deficiency , which was associated with a higher incidence of adverse events .


Thiamin supplementation might , therefore , reduce adverse events in this population .


An exploratory , double-blind , parallel group , placebo-controlled , superiority trial of thiamin supplementation in patients of all ages with uncomplicated and severe falciparum malaria was conducted in Xepon District , Savannakhet Province , southern Laos .


Patients were randomly assigned to either oral thiamin 10 mg/day for 7 days immediately after standard anti-malarial treatment then 5 mg daily until day 42 , or identical oral placebo .


After interim analyses when 630 patients ( 314 in thiamin and 316 in placebo groups ) had been recruited , the trial was discontinued on the grounds of futility .


On admission biochemical thiamin deficiency ( alpha25 % ) was present in 27 % of patients and 9 % had severe deficiency ( alpha > 31 % ) .


After 42 days of treatment , the frequency of thiamin deficiency was lower in the thiamin ( 2 % , 1 % severe ) compared to the placebo ( 11 % , 3 % severe ) groups ( p < 0.001 and p = 0.05 ) , respectively .


Except for diarrhoea , 7 % in the placebo compared to 3 % in the thiamin group ( p = 0.04 ) , and dizziness on day 1 ( 33 % vs 25 % , p = 0.045 ) , all adverse events were not significantly different between the groups ( p > 0.05 ) .


Clinical , haematological , and parasitological responses to treatment did not differ significantly between the two groups .


Thiamin supplementation reduced biochemical thiamin deficiency among Lao malaria patients following anti-malarial drug treatment , but it did not reduce the frequency of adverse events after anti-malarial therapy or have any detected clinical or parasitological impact .


ISRCTN 85411059 .


Chronic rhinosinusitis significantly impairs CF patients ' quality of life and overall health .


The Pari-Sinus device delivers vibrating aerosol effectively to paranasal sinuses .


After a small pilot study to assess sinonasal inhalation of dornase alfa and placebo ( isotonic saline ) on potential sinonasal outcome measures , we present the subsequent prospective double-blind placebo-controlled crossover-trial .


23 CF patients were randomised to inhale either dornase alfa or isotonic saline for 28 days with the Pari-Sinus and after 28 days ( wash-out ) crossed over to the alternative treatment .


The primary outcome parameter was primary nasal symptom score in the disease-specific quality of life Sino-Nasal Outcome-Test-20 ( SNOT-20 : nasal obstruction/sneezing/runny nose/thick nasal discharge/reduced smelling ) .


Primary nasal symptoms improved significantly with dornase alfa compared with no treatment , while small improvements with isotonic saline did not reach significance .


SNOT-20 overall scores improved significantly after dornase alfa compared with isotonic saline ( p = 0.017 ) .


Additionally , sinonasal dornase alfa but not isotonic saline significantly improved pulmonary function ( FEF75-25 : p = 0.021 ) .


Vibrating sinonasal inhalation of dornase alfa reduces rhinosinusitis symptoms in CF.


To determine the feasibility of conducting a randomized controlled trial comparing a low-sodium to a moderate-sodium diet in heart failure ( HF ) patients .


Patients with HF ( New York Heart Association classes II-III ) were randomized to low ( 1500 mg/d ) or moderate-sodium ( 2300 mg/d ) diet .


Dietary intake was evaluated using 3-day food records .


The end points were changes in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire ( KCCQ ) scores and B-type natriuretic peptide ( BNP ) levels from baseline to 6 months of follow-up presented as medians [ 25th , 75th percentiles ] .


Thirty-eight patients were enrolled ( 19/group ) .


After 6 months , median sodium intake declined from 2137 to 1398 mg/d in the low-sodium and from 2678 to 1461 mg/d in the moderate-sodium diet group .


Median BNP levels in the low-sodium diet group declined ( 216-71 pg/mL , P = .006 ) , whereas in the moderate-sodium diet group , there was no change in BNP ( 171-188 pg/mL , P = .7 ; P = .17 between groups ) .


For 6 months , median KCCQ clinical score increased in both groups ( 63-75 [ P = .006 ] in the low-sodium diet group and 66-73 [ P = .07 ] in the moderate-sodium group ; P = .4 between groups ) .


At 6 months , a post hoc analysis based on the dietary sodium intake achieved ( > or 1,500 mg/d ) in all patients showed an association between a sodium intake 1,500 mg/d and improvement in BNP levels and KCCQ scores .


A dietary intervention restricting sodium intake was feasible , and achievement of this sodium goal was associated with lower BNP levels and improved quality of life in patients with HF .


The aim of this article was to define risk factors for incidence of peripheral arterial disease ( PAD ) in a large cohort of patients with type 2 diabetes mellitus ( T2DM ) , overall and within the context of differing glycemic control strategies .


The Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes ( BARI 2D ) randomized controlled trial assigned participants to insulin-sensitizing ( IS ) therapy versus insulin-providing ( IP ) therapy .


A total of 1,479 participants with normal ankle-brachial index ( ABI ) at study entry were eligible for analysis .


PAD outcomes included new ABI 0.9 with decrease at least 0.1 from baseline , lower extremity revascularization , or lower extremity amputation .


Baseline risk factors within the overall cohort and time-varying risk factors within each assigned glycemic control arm were assessed using Cox proportional hazards models .


During an average 4.6 years of follow-up , 303 participants ( 20.5 % ) experienced an incident case of PAD .


Age , sex , race , and baseline smoking status were all significantly associated with incident PAD in the BARI 2D cohort .


Additional baseline risk factors included pulse pressure , HbA1c , and albumin-to-creatinine ratio ( P < 0.05 for each ) .


In stratified analyses of time-varying covariates , changes in BMI , LDL , HDL , systolic blood pressure , and pulse pressure were most predictive among IS patients , while change in HbA1c was most predictive among IP patients .


Among patients with T2DM , traditional cardiovascular risk factors were the main predictors of incident PAD cases .


Stratified analyses showed different risk factors were predictive for patients treated with IS medications versus those treated with IP medications .


To investigate the effects on plaque index ( PI ) scores of manual or electric toothbrush with or without repeated oral hygiene instructions ( OHI ) and motivation on patients wearing fixed orthodontic appliances .


One month after the orthodontic fixed appliance bonding on both arches , 60 patients were randomly assigned to four groups ; groups E1 ( n = 15 ) and E2 ( n = 15 ) received a powered rotating-oscillating toothbrush , and groups M1 ( n = 15 ) and M2 ( n = 15 ) received a manual toothbrush .


Groups E1 and M1 received OHI and motivation at baseline ( T0 ) and after 4 , 8 , 12 , 16 , and 20 weeks ( T4 , T8 , T12 , T16 , and T20 , respectively ) by a Registered Dental Hygienist ; groups E2 and M2 received OHI and motivation only at baseline .


At each time point a blinded examiner scored plaque of all teeth using the modified Quigley-Hein PI .


In all groups the PI score decreased significantly over time , and there were differences among groups at T8 , T12 , T16 , and T20 .


At T8 , PI scores of group E1 were lower than those of group E2 , and at T12 , T16 , and T20 , PI scores of groups M1 and E1 were lower compared to those of groups M2 and E2 .


A linear mixed model showed that the effect of repeated OHI and motivation during time was statistically significant , independently from the use of manual or electric toothbrush .


The present results showed that repeated OHI and motivation are crucial in reducing PI score in orthodontic patients , independent of the type of toothbrush used .


Anastomotic complications , including leaks , strictures/stenoses , and bleeding , cause considerable mortality and morbidity after colorectal surgery .


The aim of this study was to assess whether the use of a synthetic , bioabsorbable staple line reinforcement material with circular staplers would reduce postoperative anastomotic leakage in patients with a colorectal , coloanal , or ileoanal anastomosis .


This was a randomized study that compared outcomes in patients in whom the reinforcement material was used with those in patients who were not given the material .


This study was conducted at several centers in the United States .


The 258 patients ( 123 in the reinforcement group and 135 control subjects ) underwent surgery for a variety of conditions , but most ( n = 200 ) were treated for rectal cancer .


The main outcome measures were occurrence of anastomotic leaks and other complications according to the study protocol .


There were no significant differences in the 2 study groups with respect to age , BMI , ASA physical status , operating time , diagnosis , previous chemoradiotherapy , surgical technique , or 30-day complications , except for a higher rate of small-bowel obstruction ( p = 0.03 ) and anastomotic stricture ( p = 0.006 ) in the control group .


The overall anastomotic leak rate was 12 % ( bioabsorbable staple line reinforcement , 11.4 % ; no bioabsorbable staple line reinforcement , 12.6 % ) .


The study was nonblinded and was terminated at the first planned interim analysis because of insufficient power to detect an intergroup difference in anastomotic leak rate in the time allotted for the investigation .


Reinforcing the circular staple line in colorectal anastomoses with bioabsorbable material did not significantly affect the anastomotic leak rate but may have reduced anastomotic strictures .


Most strictures did not require an anastomotic revision or delay in stoma closure .


The bioabsorbable material may positively affect some aspects of the healing of circular stapled colorectal anastomoses ; however , additional research on factors associated with anastomotic leakage is needed .


To develop a genomic signature that predicts benefit from trastuzumab in human epidermal growth factor receptor 2-positive breast cancer .


DASL technology was used to quantify mRNA in samples from 1,282 patients enrolled onto the Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer ( North Central Cancer Treatment Group N9831 [ NCCTG-N9831 ] ) adjuvant trastuzumab trial .


Cox proportional hazard ratios ( HRs ) , adjusted for significant clinicopathologic risk factors , were used to determine the association of each gene with relapse-free survival ( RFS ) for 433 patients who received chemotherapy alone ( arm A ) and 849 patients who received chemotherapy plus trastuzumab ( arms B and C ) .


Network and pathway analyses were used to identify key biologic processes linked to RFS .


The signature was built by using a voting scheme .


Network and functional ontology analyses suggested that increased RFS was linked to a subset of immune function genes .


A voting scheme model was used to define immune gene enrichment based on the expression of any nine or more of 14 immune function genes at or above the 0.40 quantile for the population .


This model was used to identify immune gene-enriched tumors in arm A and arms B and C. Immune gene enrichment was linked to increased RFS in arms B and C ( HR , 0.35 ; 95 % CI , 0.22 to 0.55 ; P < .001 ) , whereas arm B and C patients who did not exhibit immune gene enrichment did not benefit from trastuzumab ( HR , 0.89 ; 95 % CI , 0.62 to 1.28 ; P = .53 ) .


Enriched immune function gene expression as defined by our predictive signature was not associated with increased RFS in arm A ( HR , 0.90 ; 95 % CI , 0.60 to 1.37 ; P = .64 ) .


Increased expression of a subset of immune function genes may provide a means of predicting benefit from adjuvant trastuzumab .


Finding current best evidence for clinical decisions remains challenging .


With 3,000 new studies published every day , no single evidence-based resource provides all answers or is sufficiently updated .


McMaster Premium LiteratUre Service -- Federated Search ( MacPLUS FS ) addresses this issue by looking in multiple high quality resources simultaneously and displaying results in a one-page pyramid with the most clinically useful at the top .


Yet , additional logistical and educational barriers need to be addressed to enhance point-of-care evidence retrieval .


This trial seeks to test three innovative interventions , among clinicians registered to MacPLUS FS , to increase the quantity and quality of searching for current best evidence to answer clinical questions .


In a user-centered approach , we designed three interventions embedded in MacPLUS FS : ( A ) a web-based Clinical Question Recorder ; ( B ) an Evidence Retrieval Coach composed of eight short educational videos ; ( C ) an Audit , Feedback and Gamification approach to evidence retrieval , based on the allocation of ` badges ' and ` reputation scores . '


We will conduct a randomized factorial controlled trial among all the 904 eligible medical doctors currently registered to MacPLUS FS at the hospitals affiliated with McMaster University , Canada .


Postgraduate trainees ( n = 429 ) and clinical faculty/staff ( n = 475 ) will be randomized to each of the three following interventions in a factorial design ( AxBxC ) .


Utilization will be continuously recorded through clinicians accounts that track logins and usage , down to the level of individual keystrokes .


The primary outcome is the rate of searches per month per user during the six months of follow-up .


Secondary outcomes , measured through the validated Impact Assessment Method questionnaire , include : utility of answers found ( meeting clinicians information needs ) , use ( application in practice ) , and perceived usefulness on patient outcomes .


Built on effective models for the point-of-care teaching , these interventions approach evidence retrieval as a clinical skill .


If effective , they may offer the opportunity to enhance it for a large audience , at low cost , providing better access to relevant evidence across many top EBM resources in parallel .


ClinicalTrials.Gov NCT02038439 .


To determine effects of probiotic consumption on clinical and immunological parameters of seasonal allergic rhinitis ( SAR ) in an out-of-season single nasal allergen challenge .


In a study registered at ClinicalTrials.Gov ( NCT01123252 ) , a 16-week dietary intervention was undertaken in 60 patients with allergic rhinitis ( > 16 years old ) .


Using a double-blinded , placebo-controlled anonymised design , the patients were divided equally into two groups .


One group was given a dairy drink containing Lactobacillus casei Shirota to ingest daily while the other consumed a similar drink without bacteria .


Participants attended the clinic on two consecutive days before the intervention and then again at the end of the study period .


On the first day of each 2-day visit , following clinical examination , assessments were made of total nasal symptoms scores and peak nasal inspiratory flow .


Nasal scrapings , nasal lavage and blood were collected for laboratory analyses of cellular phenotypes , soluble mediator release and in vitro responses to pollen allergen .


These procedures were repeated 24 hours following nasal allergen challenge .


Prior to and following intervention there were no detectable differences between study groups in measured clinical outcome .


After intervention , there were differences between groups in their percentages of CD86 + epithelial cells ( p = 0.0148 ) , CD86 + CD252 + non-epithelial cells ( p = 0.0347 ) , sIL-1RII release ( p = 0.0289 ) and IL-1 ( p = 0.0224 ) levels at the nasal mucosa .


Delivery of probiotic also suppressed production of sCD23 ( p = 0.0081 ) , TGF - ( p = 0.0283 ) and induced increased production of IFN - ( p = 0.0351 ) in supernatants of cultured peripheral blood .


This study did not show significant probiotic-associated changes with respect to the primary clinical endpoint .


An absence of overt clinical benefit may be due to an inability of single nasal challenges to accurately represent natural allergen exposure .


Nevertheless , oral delivery of probiotics produced changes of the immunological microenvironment at the nasal mucosa in individuals affected by SAR .


ClinicalTrials.Gov NCT01123252 .


To assess the effects of patient-controlled abdominal compression on postural changes in systolic blood pressure ( SBP ) associated with orthostatic hypotension ( OH ) .


Secondary variables included subject assessments of their preferences and the ease-of-use .


Randomized crossover trial .


Clinical research laboratory .


Adults with neurogenic OH ( N = 13 ) .


Four maneuvers were performed : moving from supine to standing without abdominal compression ; moving from supine to standing with either a conventional or an adjustable abdominal binder in place ; application of subject-determined maximal tolerable abdominal compression while standing ; and while still erect , subsequent reduction of abdominal compression to a level the subject believed would be tolerable for a prolonged period .


The primary outcome variable included postural changes in SBP .


Secondary outcome variables included subject assessments of their preferences and ease of use .


Baseline median SBP in the supine position was not affected by mild ( 10mmHg ) abdominal compression prior to rising ( without abdominal compression : 146mmHg ; interquartile range , 124-164mmHg ; with the conventional binder : 145mmHg ; interquartile range , 129-167mmHg ; with the adjustable binder : 153mmHg , interquartile range , 129-160mmHg ; P = .85 ) .


Standing without a binder was associated with an -57 mmHg ( interquartile range , -40 to -76 mmHg ) SBP decrease .


Levels of compression of 10mmHg applied prior to rising with the conventional and adjustable binders blunted these drops to -50 mmHg ( interquartile range , -33 to -70 mmHg ; P = .03 ) and -46 mmHg ( interquartile range , -34 to -75 mmHg ; P = .01 ) , respectively .


Increasing compression to subject-selected maximal tolerance while standing did not provide additional benefit and was associated with drops of -53 mmHg ( interquartile range , -26 to -71 mmHg ; P = .64 ) and -59 mmHg ( interquartile range , -49 to -76 mmHg ; P = .52 ) for the conventional and adjustable binders , respectively .


Subsequent reduction of compression to more tolerable levels tended to worsen OH with both the conventional ( -61 mmHg ; interquartile range , -33 to -80 mmHg ; P = .64 ) and adjustable ( -67 mmHg ; interquartile range , -61 to -84 mmHg ; P = .79 ) binders .


Subjects reported no differences in preferences between the binders in terms of preference or ease of use .


These results suggest that mild ( 10mmHg ) abdominal compression prior to rising can ameliorate OH , but further compression once standing does not result in additional benefit .


To compare the diagnostic accuracy of three-dimensional sonohysterography ( 3D-SIS ) and office hysteroscopy in uterine cavity assessment after hysteroscopic metroplasty ( HM ) and determine the interrater/intrarater agreement for 3D-SIS .


Prospective observational study .


University hospital , private hospital , and clinic .


One hundred forty-one women undergoing HM for septate uterus with a history of miscarriage and/or infertility .


3D-SIS and office hysteroscopy at 6-8 weeks after HM .


Shape of the uterine cavity , length of the fundal notch ( 1 or < 1 cm ) , and the presence of intrauterine adhesions were assessed , and the interrater/intrarater agreement of 3D-SIS was evaluated in 30 randomly selected patients .


Uterine abnormalities were detected with the use of hysteroscopy in 18 ( 12.8 % ) of 141 women .


3D-SIS was highly accurate ( 97.2 % ) , sensitive ( 97 % ) , and specific ( 100 % ) , with a positive predictive value of 100 % and a negative predictive value of 85 % .


The diagnostic values of hysteroscopy and 3D-SIS were not significantly different ( McNemar test ) .


3D-SIS showed substantial interrater/intrarater agreement regarding overall uterine cavity evaluation ( = 0.79 and 0.78 , respectively ) .


3D-SIS demonstrated substantial interrater/intrarater agreement for the postoperative evaluation of the uterine cavity , being as diagnostically accurate as hysteroscopy .


The use of second-look hysteroscopy may be limited to cases that require reoperation .


Obesity is associated with a higher risk of aggressive prostate cancer and alters circulating levels of insulin and adiponectin , two hormones that influence biologic processes implicated in carcinogenesis .


Results of some studies showed associations of circulating levels of adiponectin , insulin , and c-peptide ( a marker of insulin secretion ) with aggressive prostate cancer , but the size of these studies was limited .


A nested case-control study of 272 aggressive prostate cancer cases [ Gleason score 7 ( 4 +3 ) or T3-T4 ] and 272 age - and race-matched controls from the Cancer Prevention Study II Nutrition Cohort was conducted to determine the associations of prediagnostic plasma levels of c-peptide and adiponectin with risk of aggressive prostate cancer .


Neither circulating adiponectin nor c-peptide was associated with risk of aggressive prostate cancer .


In analyses of the highest-risk aggressive prostate cancer ( Gleason score 8 or T3-T4 ) , the highest quartile of c-peptide , compared with the lowest , was associated with an OR of 1.41 [ 95 % confidence interval ( CI ) , 0.72-2 .78 ] .


Our findings provide no support for the hypothesis that adiponectin is associated with risk of aggressive prostate cancer but a possible association of high levels of c-peptide with particularly high-risk prostate cancer can not be ruled out .


These results indicate that changes in circulating levels of adiponectin and c-peptide do not play an important role in risk of aggressive prostate cancer .


Recent studies have thrown doubt on the true effectiveness of anti-depressants in light and moderate depression .


The aim of this study is to evaluate the impact of physical training and music therapy on a sample group of subjects affected by light to moderate depression versus subjects treated with pharmacological therapy only .


Randomized controlled study .


Patients were randomized into two groups .


Subjects in the pharmacotherapy group received a therapy with antidepressant drugs ; the exercise/music therapy group was assigned to receive physical exercise training combined with listening to music .


The effects of interventions were assessed by differences in changes in mood state between the two groups .


Medically eligible patients were screened with the Hamilton Anxiety Scale and with the Geriatric Depression Scale .


We used plasmatic cytokine dosage as a stress marker .


We recruited 24 subjects ( mean age : 75.5 7.4 , 11 M/13 F ) .


In the pharmacotherapy group there was a significant improvement in anxiety only ( p < 0.05 ) at 6-months .


In the exercise/music therapy was a reduction in anxiety and in depression at 3-months and at 6-months ( p < 0.05 ) .


We noted an average reduction of the level of TNF-a from 57.67 ( 39.37 ) pg/ml to 35.80 ( 26.18 ) pg/ml .


Our training may potentially play a role in the treatment of subjects with mild to moderate depression .


Further research should be carried out to obtain more evidence on effects of physical training and music therapy in depressed subjects .


Although retrievable inferior vena cava filters are frequently used in addition to anticoagulation in patients with acute venous thromboembolism , their benefit-risk ratio is unclear .


To evaluate the efficacy and safety of retrievable vena cava filters plus anticoagulation vs anticoagulation alone for preventing pulmonary embolism recurrence in patients presenting with acute pulmonary embolism and a high risk of recurrence .


Randomized , open-label , blinded end point trial ( PREPIC2 ) with 6-month follow-up conducted from August 2006 to January 2013 .


Hospitalized patients with acute , symptomatic pulmonary embolism associated with lower-limb vein thrombosis and at least 1 criterion for severity were assigned to retrievable inferior vena cava filter implantation plus anticoagulation ( filter group ; n = 200 ) or anticoagulation alone with no filter implantation ( control group ; n = 199 ) .


Initial hospitalization with ambulatory follow-up occurred in 17 French centers .


Full-dose anticoagulation for at least 6 months in all patients .


Insertion of a retrievable inferior vena cava filter in patients randomized to the filter group .


Filter retrieval was planned at 3 months from placement .


Primary efficacy outcome was symptomatic recurrent pulmonary embolism at 3 months .


Secondary outcomes were recurrent pulmonary embolism at 6 months , symptomatic deep vein thrombosis , major bleeding , death at 3 and 6 months , and filter complications .


In the filter group , the filter was successfully inserted in 193 patients and was retrieved as planned in 153 of the 164 patients in whom retrieval was attempted .


By 3 months , recurrent pulmonary embolism had occurred in 6 patients ( 3.0 % ; all fatal ) in the filter group and in 3 patients ( 1.5 % ; 2 fatal ) in the control group ( relative risk with filter , 2.00 [ 95 % CI , 0.51-7 .89 ] ; P = .50 ) .


Results were similar at 6 months .


No difference was observed between the 2 groups regarding the other outcomes .


Filter thrombosis occurred in 3 patients .


Among hospitalized patients with severe acute pulmonary embolism , the use of a retrievable inferior vena cava filter plus anticoagulation compared with anticoagulation alone did not reduce the risk of symptomatic recurrent pulmonary embolism at 3 months .


These findings do not support the use of this type of filter in patients who can be treated with anticoagulation .


clinicaltrials.gov Identifier : NCT00457158 .


To evaluate the efficacy of a surgical no-touch isolation technique in primary hepatocellular carcinoma patients compared with traditional hepatectomy .


Eighty hepatocellular carcinoma patients were randomly divided into traditional hepatectomy ( n = 40 ) and no-touch isolation technique groups ( n = 40 ) .


We compared peripheral blood variations in alpha-fetoprotein mRNA , miRNA-221 , miRNA-224 , and miRNA-122 expression levels in both groups pre - and postoperatively using real-time fluorescent quantitative polymerase chain reaction .


The patients in the no-touch isolation technique group had better clinical curative effect .


In the traditional hepatectomy group , variations in alpha-fetoprotein mRNA copy number pre - and postoperatively indirectly indicated a significant increase in the number of exfoliated carcinoma cells induced by manipulating the liver , increasing the risk of postoperative recurrence and metastasis ( P < 0.05 ) .


Traditional hepatectomy patients showed higher increases in miRNA-221 and miRNA-224 expression than those in the no-touch isolation technique group ( P < 0.05 ) .


Tumor resection resulted in preoperative expression and high postoperative expression of miRNA-122 .


No-touch isolation technique patients showed a slight and significant increase ( P < 0.01 ) in miRNA-122 , which was positively correlated with postoperative liver function index .


Conclusion : The no-touch isolation technique is more effective than traditional hepa - tectomy in tumor resection for primary hepatocellular carcinoma .


To report the effect of nepafenac ( 0.1 % ) eye drops on intraocular pressure in eyes with cataract .


Prospective randomized clinical trial .


Three hundred and twenty-seven patients with bilateral cataracts in an institutional setting were included .


All patients had a baseline intraocular pressure ( IOP ) 21 mm Hg without a history of intraocular surgery in the past 3 months .


One eye of each individual was randomized to the treatment group , with the other eye acting as a control .


Nepafenac ( 0.1 % ) eye drops were instilled 3 times a day in the eye that received treatment .


Intraocular pressure ( IOP ) with Goldmann applanation tonometer ( GAT ) was measured at baseline and at 4 and 8 weeks .


Proportion of eyes with an IOP elevation of > 4 mm Hg was the main outcome measure .


The mean age of the participants was 45.7 4.4 years .


Participants included 192 female and 135 male patients .


The mean IOP at baseline in the treated and control eyes was , respectively , 13.8 2.5 mm Hg and 13.4 3.0 mm Hg , which reduced to 12.0 2.0 mm Hg and 12.1 1.5 mm Hg , respectively , at the end of 8 weeks .


This reduction in IOP in both groups was significant ( P < .01 ) .


The difference between the IOP in the treated and control eyes at 8 weeks was not statistically significant ( P = .34 ) .


One eye in the treated group and 2 eyes in the control group had an IOP elevation of > 4 mm Hg .


Nepafenac eye drops do not increase the IOP .


They can possibly be used as an alternative to steroid medications where steroid responsiveness is a concern .


Partitioning exercise by 1-legged cycling is more effective than conventional training in patients with chronic obstructive pulmonary disease .


Similarly , inhaling helium-hyperoxia can extend conventional exercise tolerance .


This study aimed to determine whether breathing helium-hyperoxia could increase the tolerance of a high-intensity exercise session achieved by 1-legged cycling .


Participants completed 2 high-intensity , constant power , 1-legged cycle tests to intolerance ( tlimit ) .


In a randomized order , they inspired 40 % oxygen with the balance helium via mask and 1-way valve , 1-legged helium-hyperoxia ( 1L-HH ) , or room air with supplemental oxygen via a nasal cannula , 1-legged nitrogen-hyperoxia ( 1L-NH ) .


We assessed quadriceps fatigue from the change in maximal voluntary contraction ( FMVC ) and transcutaneously stimulated twitch force ( Ftwitch ) .


Fifteen participants ( forced expiratory volume in 1 second [ SD ] = 36 [ 18 ] % predicted ; forced expiratory volume in 1 second/forced vital capacity = 34 [ 14 ] % ; peak oxygen uptake = 12.8 [ 2.9 ] mL kg min ) completed the study .


Self-reported `` leg fatigue '' was a reason for stopping 25 of 30 tests .


There was no significant difference in tlimit ( 0.2 [ -1.4 to 1.8 ] min ) between 1L-HH ( 12.2 [ 5.2 ] min ) and 1L-NH ( 12.0 [ 4.1 ] min ) , or in FMVC measured shortly after HH and NH tests ( P = .09 ) .


The Ftwitch was less after exercise ( P < .05 ) in both conditions , without a difference between conditions ( P = .46 ) .


Inspiring a helium-hyperoxia mixture does not increase the endurance of what would be a typical training session , breathing supplemental oxygen , of high-intensity 1-legged constant power exercise .


Leg muscle fatigue was similar after 1-legged exercise with and without breathing the helium mixture .


Approaches to training biomedical scientists have created a talented research community .


However , they have failed to create a professional workforce that includes many racial and ethnic minorities and women in proportion to their representation in the population or in PhD training .


This is particularly true at the faculty level .


Explanations for the absence of diversity in faculty ranks can be found in social science theories that reveal processes by which individuals develop identities , experiences , and skills required to be seen as legitimate within the profession .


Using the social science theories of Communities of Practice , Social Cognitive Career Theory , identity formation , and cultural capital , we have developed and are testing a novel coaching-based model to address some of the limitations of previous diversity approaches .


This coaching intervention ( The Academy for Future Science Faculty ) includes annual in-person meetings of students and trained faculty Career Coaches , along with ongoing virtual coaching , group meetings and communication .


The model is being tested as a randomized controlled trial with two cohorts of biomedical PhD students from across the U.S. , one recruited at the start of their PhDs and one nearing completion .


Stratification into the experimental and control groups , and to coaching groups within the experimental arms , achieved equal numbers of students by race , ethnicity and gender to the extent possible .


A fundamental design element of the Academy is to teach and make visible the social science principles which highly influence scientific advancement , as well as acknowledging the extra challenges faced by underrepresented groups working to be seen as legitimate within the scientific communities .


The strategy being tested is based upon a novel application of the well-established principles of deploying highly skilled coaches , selected and trained for their ability to develop talents of others .


This coaching model is intended to be a complement , rather than a substitute , for traditional mentoring in biomedical research training , and is being tested as such .


To determine if 8 weeks of periodized strength resistance training ( RT ) utilizing relatively short rest interval lengths ( RI ) in between sets ( SS ) would induce greater improvements in body composition and muscular performance , compared to the same RT program utilizing extended RI ( SL ) .


22 male volunteers ( SS : n = 11 , 65.6 3.4 years ; SL : n = 11 , 70.3 4.9 years ) were assigned to one of two strength RT groups , following 4 weeks of periodized hypertrophic RT ( PHRT ) : strength RT with 60-s RI ( SS ) or strength RT with 4-min RI ( SL ) .


Prior to randomization , all 22 study participants trained 3 days/week , for 4 weeks , targeting hypertrophy ; from week 4 to week 12 , SS and SL followed the same periodized strength RT program for 8 weeks , with RI the only difference in their RT prescription .


Following PHRT , all study participants experienced increases in lean body mass ( LBM ) ( p < 0.01 ) , upper and lower body strength ( p < 0.001 ) , and dynamic power ( p < 0.001 ) , as well as decreases in percentage body fat ( p < 0.05 ) .


Across the 8-week strength RT phase , SS experienced significantly greater increases in LBM ( p = 0.001 ) , flat machine bench press 1-RM ( p < 0.001 ) , bilateral leg press 1-RM ( p < 0.001 ) , narrow/neutral grip lat pulldown ( p < 0.01 ) , and Margaria stair-climbing power ( p < 0.001 ) , compared to SL .


This study suggests 8 weeks of periodized high-intensity strength RT with shortened RI induces significantly greater enhancements in body composition , muscular performance , and functional performance , compared to the same RT prescription with extended RI , in older men .


Applied professionals may optimize certain RT-induced adaptations , by incorporating shortened RI .


Coagulopathy associates with poor outcome in sepsis .


Mild induced hypothermia has been proposed as treatment in sepsis but it is not known whether this intervention worsens functional coagulopathy .


Interim analysis data from an ongoing randomized controlled trial ; The Cooling And Surviving Septic shock ( CASS ) study .


Patients suffering severe sepsis/septic shock are allocated to either mild induced hypothermia ( cooling to 32-34C for 24hours ) or control ( uncontrolled temperature ) .


NCT01455116 .


Thrombelastography ( TEG ) is performed three times during the first day after study enrollment in all patients .


Reaction time ( R ) , maximum amplitude ( MA ) and patients ' characteristics are here reported .


One hundred patients ( control n = 50 and intervention n = 50 ; male n = 59 ; median age 68years ) with complete TEG during follow-up were included .


At enrollment , 3 % , 38 % , and 59 % had a hypocoagulable , normocoagulable , and hypercoagulable TEG clot strength ( MA ) , respectively .


In the hypothermia group , functional coagulopathy improved during the hypothermia phase , measured by R and MA , in patients with hypercoagulation as well as in patients with hypocoagulation ( correlation between R and initial R : rho = -0.60 , p < 0.0001 and correlation between MA and initial MA : rho = -0.50 , p = 0.0002 ) .


Similar results were not observed in the control group neither for R ( rho = -0.03 , p = 0.8247 ) nor MA ( rho = -0.15 , p = 0.3115 ) .


Mild induced hypothermia did seem to improve functional coagulopathy in septic patients .


This improvement of functional coagulopathy parameters during the hypothermia intervention persisted after rewarming .


Randomized trials are warranted to determine whether the positive effect on sepsis-related coagulopathy can be transformed to improved survival .


To assess the efficacy of anti-xerostomic topical medication ( urea 10 % ) in patients with burning mouth syndrome ( BMS ) .


Thirty-eight subjects diagnosed with BMS according to the International Association for the Study of Pain guidelines were randomized to either placebo ( 5 % sodium carboxymethylcellulose , 0.15 % methyl paraben , and 10 % glycerol in distilled water qsp 100 g ) or treatment ( urea 10 % ) to be applied to the oral cavity 3-4 times per day for 3 months .


The patients were evaluated before and after treatment with the following instruments : the EDOF-HC protocol ( Orofacial Pain Clinic - Hospital das Clnicas ) , a xerostomia questionnaire , and quantitative sensory testing .


There were no differences in salivary flow or gustative , olfactory , or sensory thresholds ( P > 0.05 ) .


Fifteen ( 60 % ) patients reported improvement with the treatments ( P = 0.336 ) .


In conclusion , there were no differences between groups , and both exhibited an association between reported improvement and salivation .


To determine the level of agreement and potential impact on disease-modifying antirheumatic drug ( DMARD ) escalation decisions and of adding musculoskeletal ultrasound ( MSUS ) assessment of disease activity to the Disease Activity Score in 28 joints ( DAS28 ) in early rheumatoid arthritis ( RA ) .


Data were gathered from 53 early RA patients randomized to the MSUS assessment group of the Targeting Synovitis in Early Rheumatoid Arthritis study .


DAS28 scores were calculated every month .


MSUS was performed on patients with low disease activity ( DAS28 < 3.2 ) and on those with moderate disease activity ( 3.2 DAS28 < 5.1 ) without clinically swollen joints ( swollen joint count [ SJC ] 1 ) .


Fourteen joints ( bilateral proximal interphalangeal joints 2 and 3 , metacarpophalangeal [ MCP ] joints 2 and 3 , the radiocarpal , and metatarsophalangeal joints 2 and 5 ) were examined .


Active disease was defined as 2 joints demonstrating any power Doppler ( PD ) signal .


Data from 414 paired DAS28 and MSUS assessments were pooled to determine the level of agreement between each method .


A total of 369 MSUS assessments were conducted on patients with DAS28 < 3.2 ; 92 ( 25 % ) of these assessments identified active disease .


A total of 271 MSUS assessments were performed on those with DAS28 < 2.6 ; 66 ( 24 % ) of these identified active disease .


Forty-five MSUS assessments were conducted on patients with 3.2 DAS28 < 5.1 and SJC 1 ; 15 ( 33 % ) of these assessments confirmed active disease .


On 120 occasions ( 29 % ) , MSUS findings contradicted the DAS28 and led to modified treatment decisions .


The joints that most frequently exhibited PD signal were radiocarpal and index and middle MCP joints .


Compared to the DAS28 , global RA disease activity assessment using a limited MSUS joint set provided additional disease activity information and led to altered treatment decisions in a significant minority of occasions .


This may allow further tailoring of DMARD therapy by supporting DMARD escalation in patients with continuing subclinical synovitis and preventing escalation in symptomatic patients with minimal clinical and/or ultrasonographic synovitis .


Breast density is an established predictor of breast cancer risk , and there is considerable interest in associations of modifiable lifestyle factors , such as diet , with breast density .


To determine whether dietary energy density ( ED ) is associated with percent dense breast volume ( % DBV ) and absolute dense breast volume ( ADBV ) in young women .


A cross-sectional analysis was conducted with women who participated in the Dietary Intervention Study in Children Follow-Up Study .


% DBV and ADBV were measured by magnetic resonance imaging .


Diet was assessed by three 24-hour recalls .


Dietary ED ( kilocalories/gram ) was calculated using three methods : food only , food and caloric beverages , and food and all beverages .


One hundred seventy-two women ( aged 25 to 29 years ) who were enrolled in the Dietary Intervention Study in Children Follow-Up Study .


Participants who reported breast augmentation or reduction surgery or were pregnant or lactating within 3 months before breast density assessment were excluded .


ADBV and % DBV .


Multivariable linear mixed effects models were used .


Final models were adjusted for race , smoking status , education , parity , duration of sex hormone use , whole body percent fat , childhood body mass index z score , and energy from beverages .


After adjustment , each 1 kcal/g unit increase in food-only ED was associated with a 25.9 % ( 95 % CI 6.2 % to 56.8 % ) increase in % DBV ( P = 0.01 ) .


Childhood body mass index z score modified the association between food-only ED and % DBV such that a significant positive association was observed only in women who were heavier as children .


Food-only ED was not associated with ADBV in all women , but a borderline significant positive association was observed in women who had higher childhood body mass index z scores .


This is the first report to suggest a potential role for dietary ED in breast density ; the effects of long-term exposure to high-ED diets on breast cancer risk remain unknown .


To our knowledge , there is no level 1 evidence comparing open bypass with angioplasty and stenting in TransAtlantic Inter-Society Consensus ( TASC II ) B and C superficial femoral artery lesions .


The Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial ( ROBUST ) is the first prospective randomized clinical trial comparing both treatments .


To report the design of the ROBUST trial .


The primary aim of the trial is to compare ( 1 ) the patency rate ( primary , primary assisted , and secondary patency at 6 and 12 months ) , ( 2 ) improvement of quality of life , ( 3 ) clinical improvement ( at least 1 Rutherford category ) , and ( 4 ) wound healing and limb salvage in patients presenting with critical limb ischemia ; secondary aims include ( 1 ) cost-effectiveness by factoring procedure and hospital admission costs including rehabilitation , readmission , and reintervention costs , ( 2 ) amputation-free survival , ( 3 ) reintervention rate , and ( 4 ) 30-day operative mortality , morbidity , and wound and access complications .


ROBUST is a prospective randomized clinical trial with the aim to enroll 320 patients with intermittent claudication that does not respond to medical management and patients with critical limb ischemia .


The maximum level of medical therapy will be administered using antiplatelet agents and statins , as well as measures to control hypertension and diabetes mellitus .


Patients with TASC II B or C lesions are prospectively randomized to receive either femoropopliteal bypass or percutaneous transluminal angioplasty and stenting ; patients with TASC II A and D lesions are not randomized and receive percutaneous transluminal angioplasty and stenting or femoropopliteal bypass , respectively .


All patients will be evaluated at 1 , 6 , and 12 months postoperatively with physical examination , ankle brachial index , duplex , and a quality-of-life questionnaire .


The trial is actively enrolling participants .


At the time of writing , 29 patients have been enrolled ; most are male ( 60 % ) and white ( 65 % ) .


Providing level 1 evidence , ROBUST may help to establish guidelines for the treatment of superficial femoral artery lesions , eliminate unnecessary procedures , and reduce health care costs .


clinicaltrials.gov Identifier : NCT01602159 .


We evaluated the safety , tolerability , and pharmacokinetics ( PK ) of EMD 525797 ( DI17E6 ) , a humanized monoclonal antibody targeting v-integrins , in healthy subjects .


In this first-in-human , double-blind , placebo-controlled , randomized Phase 1 study , healthy male volunteers were consecutively assigned to 6 ascending single-dose cohorts of 35 , 100 , 250 , 500 , 1000 , or 1500 mg .


Per dose cohort , EMD 525797 or placebo was administered over 1 h as an intravenous 250-mL infusion to 6 and 3 volunteers , respectively .


Escalation to the next dose level was based on evaluation of safety , tolerability , and PK data .


Fifty-five subjects ( aged 18-45 years ) were randomized .


Twenty-seven of 37 ( 73 % ) subjects receiving EMD 525797 reported a total of 61 adverse events ( AEs ) , including 38 events ( in 17 subjects ) considered by the investigator to be treatment related .


A total of 35 AEs were reported by 14 of 18 ( 78 % ) placebo-treated subjects .


The most commonly occurring AEs were gastrointestinal disorders , abnormal laboratory values , and increased or decreased biochemistry and/or hematology values , as well as headaches , which occurred at a slightly higher frequency in the EMD 525797 group compared with placebo .


There were no serious AEs or deaths .


EMD 525797 PK appeared to be dose dependent , especially at lower doses .


Ascending single doses of EMD 525797 were shown to be safe and well tolerated .


No safety concerns were identified .


This study supports the ongoing investigation of EMD 525797 .


Erythromycin is a macrolide antibiotic , which is frequently used as a topical formulation for the treatment of acne .


It is also known as an inhibitor of the cytochrome P450 ( CYP ) isoenzyme 3A4 .


In this study , the systemic availability of topical erythromycin , hence the influence on the activity of CYP3A , is evaluated in comparison to orally administered erythromycin .


Sixteen healthy volunteers received consecutively topical ( two applications of 800mg ) and oral erythromycin ( two dose groups , 250 and 1000mg , with n = 8 ) to assess erythromycin pharmacokinetics .


A microdose of midazolam ( 3g orally ) was used to determine the effect on CYP3A activity .


After topical administration , erythromycin was detected in the plasma of every participant without causing a statistically significant alteration of CYP3A activity .