We report the protocol of the Enhancing Living Donor Kidney Transplant Education ( ELITE ) Study , a cluster randomized trial of an educational intervention to be implemented during initial transplant evaluation at a large , suburban U.S. transplant center .


Five hundred potential transplant candidates are cluster randomized ( by date of visit ) to receive either : ( 1 ) standard-of-care ( `` usual '' ) transplant education , or ( 2 ) intensive education that is based upon the Explore Transplant series of educational materials .


Intensive transplant education includes viewing an educational video about LDKT , receiving print education , and meeting with a transplant educator .


The primary outcome consists of knowledge of the benefits , risks , and process of LDKT , assessed one week after the transplant evaluation .


As a secondary outcome , knowledge and understanding of LDKT are assessed 3 months after the evaluation .


Additional secondary outcomes , assessed one week and 3 months after the evaluation , include readiness , self-efficacy , and decisional balance regarding transplant and LDKT , with differences assessed by race .


Although the unit of randomization is the date of the transplant evaluation visit , the unit of analysis will be the individual potential transplant candidate .


The ELITE Study will help to determine how education in a transplant center can best be designed to help Black and non-Black patients learn about the option of LDKT .


Clinicaltrials.gov number NCT01261910 .


Controversy exists about whether cutting diathermy for skin incisions leads to a cosmetically inferior scar .


Cosmetic outcomes were compared between skin incisions created with cutting diathermy versus scalpel .


Wound infection rates and postoperative incisional pain were also compared .


This was a randomized double-blind trial comparing cutting diathermy and scalpel in patients undergoing bowel resection .


Scar cosmesis was assessed at 6 months after surgery by a plastic surgeon and a research associate using the Vancouver Scar Scale ( VSS ) and the Patient and Observer Scar Assessment Scale ( POSAS ) .


Patients also used POSAS to self-evaluate their scars .


Wound infections within 30 days were recorded , and incision pain scores were measured on the first 5 days after operation .


A total of 66 patients were randomized to cutting diathermy ( 31 ) or scalpel ( 35 ) .


At 6 months , there was no significant difference between the diathermy and scalpel groups in mean ( s.d. ) VSS scores ( 49 ( 26 ) versus 50 ( 19 ) ; P = 0837 ) , mean POSAS total scores ( 192 ( 80 ) versus 200 ( 74 ) ; P = 0684 ) or subjective POSAS total scores ( 202 ( 121 ) versus 213 ( 104 ) ; P = 0725 ) .


Neither were there significant differences in wound infection rates between the groups ( 5 of 30 versus 5 of 32 ; P = 1000 ) .


Pain scores on day 1 after operation were significantly lower in the diathermy group ( mean 168 versus 313 ; P = 0018 ) , but were not significantly different on days 2-5 .


Cutting diathermy is a cosmetically acceptable technique for abdominal skin incisions .


There is no increased risk of wound infection , and diathermy may convey benefit in terms of early postoperative wound pain .


NCT01496404 ( http://www.clinicaltrials.gov ) .


We evaluated the effect of a weight gain prevention intervention ( Shape Program ) on depression among socioeconomically disadvantaged overweight and obese Black women .


Between 2009 and 2012 , we conducted a randomized trial comparing a 12-month electronic health-based weight gain prevention intervention to usual primary care at 5 central North Carolina community health centers .


We assessed depression with the Patient Health Questionnaire ( PHQ-8 ) .


We analyzed change in depression score from baseline to 12 - and 18-month follow-up across groups with mixed models .


We used generalized estimating equation models to analyze group differences in the proportion above the clinical threshold for depression ( PHQ-8 score 10 ) .


At baseline , 20 % of participants reported depression .


Twelve-month change in depression scores was larger for intervention participants ( mean difference = -1.85 ; 95 % confidence interval = -3.08 , -0.61 ; P = .004 ) .


There was a significant reduction in the proportion of intervention participants with depression at 12 months with no change in the usual-care group ( 11 % vs 19 % ; P = .035 ) .


All effects persisted after we controlled for weight change and medication use .


We saw similar findings at 18 months .


The Shape Program , which includes no mention of mood , improved depression among socioeconomically disadvantaged Black women .


To evaluate whether trait and experimentally manipulated state disgust independently and/or interactively predict immediate and anticipated avoidance in decision scenarios related to colorectal cancer ( CRC ) .


Eighty participants , aged 18 to 66 years , completed questionnaires assessing trait disgust prior to a laboratory session .


Participants were gender block randomized to disgust or control conditions before completing tasks assessing immediate avoidance of a CRC disgust elicitor ( stoma bag ) and anticipated avoidance in hypothetical CRC scenarios .


Manipulation checks confirmed the elicitation of disgust in the experimental condition .


Persons in the experimental condition were more likely to exhibit immediate avoidance behaviors in response to a commonly used bowel disease device ( stoma bag ) , and trait disgust predicted time to touch the device .


Trait disgust also moderated the influence of state disgust on anticipated avoidance , namely delay in help seeking for bowel symptoms and predicted rating disgusting side effects as more deterring to adherence .


The current report suggests the importance of examining disgust in CRC contexts and provides the first empirical demonstration that state and trait aspects of disgust may interactively operate to deter certain types of decisions .


It thus furthers understanding of emotions and avoidance in a health context that has had surprisingly little focus to date .


High rates of sustained virologic response were observed among patients with hepatitis C virus ( HCV ) infection who received 12 weeks of treatment with the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor ledipasvir .


This study examined 8 weeks of treatment with this regimen .


In this phase 3 , open-label study , we randomly assigned 647 previously untreated patients with HCV genotype 1 infection without cirrhosis to receive ledipasvir and sofosbuvir ( ledipasvir-sofosbuvir ) for 8 weeks , ledipasvir-sofosbuvir plus ribavirin for 8 weeks , or ledipasvir-sofosbuvir for 12 weeks .


The primary end point was sustained virologic response at 12 weeks after the end of therapy .


The rate of sustained virologic response was 94 % ( 95 % confidence interval [ CI ] , 90 to 97 ) with 8 weeks of ledipasvir-sofosbuvir , 93 % ( 95 % CI , 89 to 96 ) with 8 weeks of ledipasvir-sofosbuvir plus ribavirin , and 95 % ( 95 % CI , 92 to 98 ) with 12 weeks of ledipasvir-sofosbuvir .


As compared with the rate of sustained virologic response in the group that received 8 weeks of ledipasvir-sofosbuvir , the rate in the 12-week group was 1 percentage point higher ( 97.5 % CI , -4 to 6 ) and the rate in the group that received 8 weeks of ledipasvir-sofosbuvir with ribavirin was 1 percentage point lower ( 95 % CI , -6 to 4 ) ; these results indicated noninferiority of the 8-week ledipasvir-sofosbuvir regimen , on the basis of a noninferiority margin of 12 percentage points .


Adverse events were more common in the group that received ribavirin than in the other two groups .


No patient who received 8 weeks of only ledipasvir-sofosbuvir discontinued treatment owing to adverse events .


Ledipasvir-sofosbuvir for 8 weeks was associated with a high rate of sustained virologic response among previously untreated patients with HCV genotype 1 infection without cirrhosis .


No additional benefit was associated with the inclusion of ribavirin in the regimen or with extension of the duration of treatment to 12 weeks .


( Funded by Gilead Sciences ; ION-3 ClinicalTrials.gov number , NCT01851330 . )


Investigate the efficacy of nabilone capsules ( NAB ) in reducing the frequency and intensity of nightmares in subjects with PTSD .


Canadian male military personnel with PTSD , who despite standard treatment continued to experience trauma-related nightmares , received double-blind treatment with 0.5 mg NAB or placebo ( PBO ) , and then titrated to the effective dose ( nightmare suppression ) or reaching a maximum of 3.0 mg .


Subjects were followed for 7 weeks and then , following a 2-week washout period , were titrated with the other study treatment and followed for an additional 7 weeks .


The modified intent-to-treat ( mITT ) population , which included all treated subjects that met inclusion/exclusion criteria , was analyzed .


Ten subjects were included in the mITT population .


The mean reduction in nightmares as measured by the CAPS Recurring and Distressing Dream scores were -3.6 2.4 and -1.0 2.1 in the NAB and PBO groups , respectively ( p = 0.03 ) .


Mean global improvement as measured by the Clinical Global Impression of Change ( CGI-C ) was 1.9 1.1 ( i.e. much improved ) and 3.2 1.2 ( i.e. minimally improved ) in the NAB and PBO groups , respectively ( p = 0.05 ) Five out of 10 ( 50 % ) were much improved on NAB versus 1 out of 9 ( 11 % ) on PBO .


Results for the General Well Being Questionnaire ( WBQ ) were 20.8 22 and -0.4 20.6 in the NAB and PBO groups , respectively ( p = 0.04 ) .


The proportion of subjects who experienced a treatment-related occurrence of adverse events was 50 % in the NBO group and 60 % in the PBO group .


No event was severe nor resulted in a drop-out .


This study is registered with Health Canada .


In this small sample NAB provided significant relief for military personnel with PTSD , indicating that it shows promise as a clinically-relevant treatment for patients with nightmares and a history of non-response to traditional therapies .


These findings need to be replicated in a larger cohort .


There is a need for further exploration of the effect of nabilone on other symptoms of PTSD such as re-experiencing , hyper vigilance and insomnia .


Patients with bone metastases have a widely varying survival .


A reliable estimation of survival is needed for appropriate treatment strategies .


Our goal was to assess the value of simple prognostic factors , namely , patient and tumor characteristics , Karnofsky performance status ( KPS ) , and patient-reported scores of pain and quality of life , to predict survival in patients with painful bone metastases .


In the Dutch Bone Metastasis Study , 1157 patients were treated with radiation therapy for painful bone metastases .


At randomization , physicians determined the KPS ; patients rated general health on a visual analogue scale ( VAS-gh ) , valuation of life on a verbal rating scale ( VRS-vl ) and pain intensity .


To assess the predictive value of the variables , we used multivariate Cox proportional hazard analyses and C-statistics for discriminative value .


Of the final model , calibration was assessed .


External validation was performed on a dataset of 934 patients who were treated with radiation therapy for vertebral metastases .


Patients had mainly breast ( 39 % ) , prostate ( 23 % ) , or lung cancer ( 25 % ) .


After a maximum of 142 weeks ' follow-up , 74 % of patients had died .


The best predictive model included sex , primary tumor , visceral metastases , KPS , VAS-gh , and VRS-vl ( C-statistic = 0.72 , 95 % CI = 0.70-0 .74 ) .


A reduced model , with only KPS and primary tumor , showed comparable discriminative capacity ( C-statistic = 0.71 , 95 % CI = 0.69-0 .72 ) .


External validation showed a C-statistic of 0.72 ( 95 % CI = 0.70-0 .73 ) .


Calibration of the derivation and the validation dataset showed underestimation of survival .


In predicting survival in patients with painful bone metastases , KPS combined with primary tumor was comparable to a more complex model .


Considering the amount of variables in complex models and the additional burden on patients , the simple model is preferred for daily use .


In addition , a risk table for survival is provided .


Surgical stress may cause immunosuppression especially in patients who have surgery for primary tumor removed .


This study aimed to explore the effects of dexmedetomidine on immune and inflammatory response in patients undergoing radical gastrectomy .


After the institutional review board approval and written informed consent , forty patients undergoing radical gastrectomy were equally randomized to receive dexmedetomidine infusion ( Dex group ; 0.5 g kg ( -1 ) initial dose followed by a maintenance dose of 0.4 g kg ( -1 ) h ( -1 ) ) or normal saline infusion ( NS group ) .


Helper T lymphocytes ( T helper 1 [ Th1 ] and T helper 2 [ Th2 ] ) , tumor necrosis factor - , and interleukin-6 were measured during and after surgeries .


Plasma catecholamine levels were also measured during surgery .


Postoperative pain was measured by a visual analog scale .


The percentage of Th1 increased significantly at the end of surgery , 24 h after surgery ( P = 0.045 and 0.048 , respectively ) , and Th2 decreased notably at the end of surgery in the Dex group ( P = 0.030 ) .


Plasma levels of tumor necrosis factor - ( P = 0.045 and 0.036 , respectively ) and interleukin-6 ( P = 0.049 and 0.042 , respectively ) differed significantly at the end of surgery and 24 h after surgery .


Plasma epinephrine and norepinephrine levels decreased significantly at the beginning of surgery in the Dex group ( P = 0.020 and 0.015 , respectively ) .


At the end of surgery , plasma dopamine levels decreased significantly in the Dex group ( P = 0.048 ) , but increased in the NS group .


The visual analog scale pain score was lower in the Dex group than in the NS group 24 h after surgery ( P = 0.046 ) .


Dexmedetomidine has been shown to reduce surgical stresses and maintain Th1/Th2 balance .


It has been shown to reduce inflammatory responses and exerts immunoprotective effect .


Although parental support is an important component in overweight prevention programs for children , current programs pay remarkably little attention to the role of parenting .


To close this gap , we developed a web-based parenting program for parents entitled `` Making a healthy deal with your child '' .


This e-learning program can be incorporated into existing prevention programs , thereby improving these interventions by reinforcing the role of parenting and providing parents with practical tools for use in everyday situations in order to stimulate a healthy lifestyle .


Here , we report the research design of a study to determine the effectiveness of our e-learning program .


The effectiveness of an e-learning program was studied in a two-armed cluster randomized controlled trial .


Parents of children 9-13 years of age who live in the Nijmegen region , the Netherlands , and who participated in the existing school-based overweight prevention program `` Scoring for Health '' were invited to participate in this study .


Our goal was to recruit 322 parent-child dyads .


At the school grade level , parents were randomly assigned to either the intervention group ( which received e-learning and a brochure ) or the control group ( which received only the brochure ) ; the participants were stratified by ethnicity .


Measurements were taken from both the parents and the children at baseline , and then 5 and 12months after baseline .


Primary outcomes included the child 's dietary and sedentary behavior , and level of physical activity .


Secondary outcomes included general parenting style , specific parenting practices ( e.g. , set of rules , modeling , and monitoring ) , and parental self-efficacy .


We hypothesize that children of parents who follow the e-learning program will have a healthier diet , will be less sedentary , and will have a higher level of physical activity compared to the children in the control group .


If the e-learning program is found to be effective , it can be incorporated into existing overweight prevention programs for children ( e.g. , `` Scoring for Health '' ) , as well as activities regarding Youth Health Care .


Dutch Trial Register : NTR3938 .


Date of registration : April 7 ( th ) , 2013 .


Severe neglect in early life is associated with compromises in brain development and associated behavioral functioning .


Although early intervention has been shown to support more normative trajectories of brain development , specific improvements in the white matter pathways that underlie emotional and cognitive development are unknown .


To examine associations among neglect in early life , early intervention , and the microstructural integrity of white matter pathways in middle childhood .


The Bucharest Early Intervention Project is a randomized clinical trial of high-quality foster care as an intervention for institutionally reared children in Bucharest , Romania , from 2000 through the present .


During infancy , children were randomly selected to remain in an institution or to be placed in foster care .


Those who remained in institutions experienced neglect , including social , emotional , linguistic , and cognitive impoverishment .


Developmental trajectories of these children were compared with a group of sociodemographically matched children reared in biological families at baseline and several points throughout development .


At approximately 8 years of age , 69 of the original 136 children underwent structural magnetic resonance imaging scans .


Four estimates of white matter integrity ( fractional anisotropy [ FA ] and mean [ MD ] , radial [ RD ] , and axial [ AD ] diffusivity ) for 48 white matter tracts throughout the brain were obtained through diffusion tensor imaging .


Significant associations emerged between neglect in early life and microstructural integrity of the body of the corpus callosum ( FA , = 0.01 [ P = .01 ] ; RD , = -0.02 [ P = .005 ] ; MD , = -0.01 [ P = .02 ] ) and tracts involved in limbic circuitry ( fornix crus [ AD , = 0.02 ( P = .046 ) ] and cingulum [ RD , = -0.01 ( P = .02 ) ; MD , = -0.01 ( P = .049 ) ] ) , frontostriatal circuitry ( anterior [ AD , = -0.01 ( P = .02 ) ] and superior [ AD , = -0.02 ( P = .02 ) ; MD , = -0.01 ( P = .03 ) ] corona radiata and external capsule [ right FA , = 0.01 ( P = .03 ) ; left FA , = 0.01 ( P = .03 ) ; RD , = -0.01 ( P = .01 ) ; MD , = -0.01 ( P = .03 ) ] ) , and sensory processing ( medial lemniscus [ AD , = -0.02 ( P = .045 ) ; MD , = -0.01 ( P = .04 ) ] and retrolenticular internal capsule [ FA , = -0.01 ( P = .002 ) ; RD , = 0.01 ( P = .003 ) ; MD , = 0.01 ( P = .04 ) ] ) .


Follow-up analyses revealed that early intervention promoted more normative white matter development among previously neglected children who entered foster care .


Results suggest that removal from conditions of neglect in early life and entry into a high-quality family environment can support more normative trajectories of white matter growth .


Our findings have implications for public health and policy efforts designed to promote normative brain development among vulnerable children .


clinicaltrials.gov Identifier : NCT00747396 .


Famitinib is a novel and potent multitargeting receptor tyrosine kinase inhibitor .


The phase I clinical study showed that famitinib was well tolerated and had a broad anti-tumor spectrum .


The purpose of this study was to examine the efficacy and safety of famitinib for the treatment of metastatic renal cell carcinoma ( mRCC ) .


The data of famitinib in treating patients with mRCC from the single-center phases I and II clinical trials were analyzed .


Famitinib was administered orally at the dose of 13-30 mg once daily until tumor progression , occurrence of intolerable adverse reactions or withdrawal of the informed consent .


A total of 24 patients with mRCC were treated including 17 patients at a dose of 25 mg once daily , 4 patients at a dose of 27 mg and 1 patient each at a dose of 13 mg , 20 mg and 30 mg , respectively .


Twelve ( 50.0 % ) patients achieved partial response ( PR ) and 9 patients achieved stable disease ( SD ) .


Progressive disease was found in 3 ( 12.5 % ) patients .


The disease control rate was 87.5 % .


The median follow-up time was 17.6 months ; the median progression free survival ( PFS ) was 10.7 ( 95 % CI 7.0-14 .4 ) months ; and the estimated median overall survival ( OS ) time was 33.0 ( 95 % CI 8.7-57 .3 ) months .


The adverse drug reactions mainly included hypertension ( 54.1 % ) , hand-foot skin reactions ( 45.8 % ) , diarrhea ( 33.3 % ) , mucositis ( 29.2 % ) , neutropenia ( 45.8 % ) , thrombocytopenia ( 29.2 % ) , hyperlipidemia ( 41.7 % ) and proteinuria ( 41.7 % ) .


The incidence rate of grades 3 and 4 adverse events was low , mainly including hypertension 12.5 % , hand-foot skin reactions 4.2 % , neutropenia 4.2 % , thrombocytopenia 4.2 % , hyperlipidemia 4.2 % and proteinuria 12.5 % .


Famitinib has significant anti-tumor activity in mRCC .


The common adverse reactions are generally manageable .


The aim of this research was to assess the delayed effects of a two-year alcohol prevention program implemented in Polish primary schools .


The program comprised two curricula implemented the school and in family houses : Program Domowych Detektyww and Fantastyczne Mozliwoci .


Both curricula were the Polish versions of two American school-based prevention programs which belonged to Project Northland .


The initial study sample ( N = 802 ) comprised 10 to 11 years old pupils ( fourth and fifth-grade ) from eight primary schools in Warsaw .


Schools were randomly assigned to the intervention ( n = 421 ) and the reference group ( n = 381 ) .


A self-completion questionnaire was administered to students four times : at the baseline , seven , fifteen and twenty seven months after .


The program had an expected influence on the students ' attitudes , knowledge and resistance skills towards alcohol .


The effects on the participants ' initiation of drunkenness and their first experience in alcohol use with their peers have also been reported .


Most of the positive effects remained significant over time .


The effectiveness of the program , as shown by the outcome evaluation , supports an argument for its wide implementation in Polish schools .


Further progress in the field of alcohol and drug prevention in Poland depends on overcoming the existing barriers in this area of public health .


To investigate the efficacy and tolerability of empagliflozin as an add-on to metformin therapy in patients with type 2 diabetes .


Patients with HbA1c levels of 7 % to 10 % ( 53 to 86 mmol/mol ) while receiving metformin ( 1,500 mg/day ) were randomized and treated with once-daily treatment with empagliflozin 10 mg ( n = 217 ) , empagliflozin 25 mg ( n = 213 ) , or placebo ( n = 207 ) for 24 weeks .


The primary end point was the change in HbA1c level from baseline at week 24 .


Key secondary end points were changes from baseline in weight and mean daily glucose ( MDG ) at week 24 .


At week 24 , adjusted mean ( SE ) changes from baseline in HbA1c were -0.13 % ( 0.05 ) % ( -1.4 [ 0.5 ] mmol/mol ) with placebo , -0.70 % ( 0.05 ) % ( -7.7 [ 0.5 ] mmol/mol ) with empagliflozin 10 mg , and -0.77 % ( 0.05 ) % ( -8.4 [ 0.5 ] mmol/mol ) with empagliflozin 25 mg ( both P < 0.001 ) .


Empagliflozin significantly reduced MDG level and systolic and diastolic blood pressure ( BP ) versus placebo .


Adjusted mean ( SE ) changes from baseline in weight were -0.45 kg ( 0.17 kg ) with placebo , -2.08 kg ( 0.17 kg ) with empagliflozin 10 mg , and -2.46 kg ( 0.17 kg ) with empagliflozin 25 mg ( both P < 0.001 ) .


Adverse events ( AEs ) were similar across groups ( placebo 58.7 % ; empagliflozin 49.5-57 .1 % ) .


Confirmed hypoglycemic AEs were reported in 0.5 % , 1.8 % , and 1.4 % of patients receiving placebo , empagliflozin 10 mg , and empagliflozin 25 mg , respectively .


Events consistent with urinary tract infections were reported in 4.9 % , 5.1 % , and 5.6 % of patients , and events consistent with genital infections were reported in 0 % , 3.7 % , and 4.7 % of patients , respectively .


Empagliflozin 10 and 25 mg for 24 weeks as add-on to metformin therapy significantly improved glycemic control , weight , and BP , and were well-tolerated .


Centre-based childcare services represent a promising setting to target the prevention of excessive weight gain in preschool-aged children .


Staff training is a key component of multi-strategy interventions to improve implementation of effective physical activity and nutrition promoting practices for obesity prevention in childcare services .


This randomised controlled trial aimed to examine whether an active telephone-based strategy to invite childcare-service staff to attend a training workshop was effective in increasing the proportion of services with staff attending training , compared with a passive strategy .


Services were randomised to an active telephone-based or a passive-recruitment strategy .


Those in the active arm received an email invitation and one to three follow-up phone calls , whereas services in the passive arm were informed of the availability of training only via newsletters .


The proportion of services with staff attending the training workshop was compared between the two arms .


One hundred and twenty-eight services were included in this study .


A significantly larger proportion ( 52 % ) of services in the active arm compared with those in the passive-strategy arm ( 3.1 % ) attended training ( d.f. = 1 , 2 = 34.3 ; P < 0.001 ) .


An active , telephone-based recruitment strategy significantly increased the proportion of childcare services with staff attending training .


Further strategies to improve staff attendance at training need to be identified and implemented .


SO WHAT ?


: Active-recruitment strategies including follow-up telephone calls should be utilised to invite staff to participate in training , in order to maximise the use of training as an implementation strategy for obesity prevention in childcare services .


An aluminum hydroxide-adsorbed depot allergoid preparation of six-grass pollen allergens has been developed for short-term preseasonal immunotherapy in pollinosis .


However , only limited knowledge exists about its immunological and clinical effects .


The aim of this study was to evaluate the basophil response , which can explain early clinical findings of short-term preseasonal allergoid immunotherapy in allergic rhinitis .


In a double-blind , placebo-controlled study , 31 patients allergic to grass pollens received one course of short-term preseasonal allergoid immunotherapy or placebo .


Immunogenicity was assessed by the levels of specific IgG4 , IgE antibodies and an allergen-induced CD203c basophil activation test .


The primary clinical end point was the combined symptom and medication score/average combined score ( ACS ) .


There was a 52.9 % difference in ACS between the treatment and placebo groups in favor of immunotherapy ( p = 0.01 ) .


Active treatment induced Phleum pratense-specific IgG4 and IgE antibodies ( p < 0.05 ) .


A decrease in allergen-induced basophil activation at submaximal allergen concentrations was demonstrated at the end of immunotherapy and at the peak of the grass pollen season after immunotherapy .


This study shows that grass pollen-allergic patients treated with one course of short-term preseasonal allergoid immunotherapy exhibit a decrease in allergen-induced basophil activation , an increase in allergen-specific IgG4 antibodies and early clinical improvement .


To examine the effects of a whole-body cryotherapy ( WBC ) protocol ( 3 min at -110 C ) on acute recovery and key variables of endurance performance during high-intensity intermittent exercise in a thermoneutral environment .


Eleven endurance athletes were tested twice in a randomized crossover design in which 55 min of high-intensity running ( HIR ) were followed by 1 h of passive rest at ~ 22C , including either 3 min of whole-body exposure to -110 C ( WBC ) or a placebo intervention of 3 min walking ( PBO ) .


A ramp-test protocol was performed before HIR ( R1 ) and after the 1-h recovery period ( R2 ) .


Time to exhaustion ( tlim ) was measured along with alterations in oxygen content of the vastus lateralis ( TSI ) , oxygen consumption ( VO2 ) , capillary blood lactate , heart rate ( HR ) , and rating of perceived exertion ( RPE ) during submaximal and maximal running .


The difference in tlim between R1 and R2 was lower in WBC than in PBO ( P < .05 , effect size d = 1.13 ) .


During R2 , TSI was higher in WBC during submaximal and maximal running ( P < .01 , d = 0.68-1 .01 ) .


In addition , VO2 , HR , and RPE were lower at submaximal level of R2 after WBC than in PBO ( P = .04 to < .01 , d = 0.23-0 .83 ) .


WBC improves acute recovery during high-intensity intermittent exercise in thermoneutral conditions .


The improvements might be induced by enhanced oxygenation of the working muscles , as well as a reduction in cardiovascular strain and increased work economy at submaximal intensities .


Previously , a healthy Nordic diet ( ND ) has been shown to have beneficial health effects close to those of Mediterranean diets .


The objective was to explore whether the ND has an impact on gene expression in abdominal subcutaneous adipose tissue ( SAT ) and whether changes in gene expression are associated with clinical and biochemical effects .


Obese adults with features of the metabolic syndrome underwent an 18 - to 24-wk randomized intervention study comparing the ND with the control diet ( CD ) ( the SYSDIET study , carried out within Nordic Centre of Excellence of the Systems Biology in Controlled Dietary Interventions and Cohort Studies ) .


The present study included participants from 3 Nordic SYSDIET centers [ Kuopio ( n = 20 ) , Lund ( n = 18 ) , and Oulu ( n = 18 ) ] with a maximum weight change of 4 kg , highly sensitive C-reactive protein concentration < 10 mg/L at the beginning and the end of the intervention , and baseline body mass index ( in kg/m ) < 38 .


SAT biopsy specimens were obtained before and after the intervention and subjected to global transcriptome analysis with Gene 1.1 ST Arrays ( Affymetrix ) .


Altogether , 128 genes were differentially expressed in SAT between the ND and CD ( nominal P < 0.01 ; false discovery rate , 25 % ) .


These genes were overrepresented in pathways related to immune response ( adjusted P = 0.0076 ) , resulting mainly from slightly decreased expression in the ND and increased expression in the CD .


Immune-related pathways included leukocyte trafficking and macrophage recruitment ( e.g. , interferon regulatory factor 1 , CD97 ) , adaptive immune response ( interleukin32 , interleukin 6 receptor ) , and reactive oxygen species ( neutrophil cytosolic factor 1 ) .


Interestingly , the regulatory region of the 128 genes was overrepresented for binding sites for the nuclear transcription factor B.


A healthy Nordic diet reduces inflammatory gene expression in SAT compared with a control diet independently of body weight change in individuals with features of the metabolic syndrome .


To investigate the effects of anodal transcranial direct current stimulation ( a-tDCS ) intensity on corticospinal excitability and affected muscle activation in individuals with chronic spinal cord injury ( SCI ) .


Single-blind , randomized , sham-controlled , crossover study .


Medical research institute and rehabilitation hospital .


Volunteers ( N = 9 ) with chronic SCI and motor dysfunction in wrist extensor muscles .


Three single session exposures to 20 minutes of a-tDCS ( anode over the extensor carpi radialis [ ECR ] muscle representation on the left primary motor cortex , cathode over the right supraorbital area ) using 1 mA , 2 mA , or sham stimulation , delivered at rest , with at least 1 week between sessions .


Corticospinal excitability was assessed with motor-evoked potentials ( MEPs ) from the ECR muscle using surface electromyography after transcranial magnetic stimulation .


Changes in spinal excitability , sensory threshold , and muscle strength were also investigated .


Mean MEP amplitude significantly increased by approximately 40 % immediately after 2mA a-tDCS ( pre : 0.36 0.1 mV ; post : 0.47 0.11 mV ; P = .001 ) , but not with 1 mA or sham .


Maximal voluntary contraction measures remained unaltered across all conditions .


Sensory threshold significantly decreased over time after 1mA ( P = .002 ) and 2mA ( P = .039 ) a-tDCS and did not change with sham .


F-wave persistence showed a nonsignificant trend for increase ( pre : 32 % 12 % ; post : 41 % 10 % ; follow-up : 46 % 12 % ) after 2 mA stimulation .


No adverse effects were reported with any of the experimental conditions .


The a-tDCS can transiently raise corticospinal excitability to affected muscles in patients with chronic SCI after 2 mA stimulation .


Sensory perception can improve with both 1 and 2 mA stimulation .


This study gives support to the safe and effective use of a-tDCS using small electrodes in patients with SCI and highlights the importance of stimulation intensity .


The feasibility and safety of D2 surgery following neoadjuvant chemotherapy ( NAC ) has not been fully evaluated in patients with gastric cancer .


Moreover , risk factor for surgical complications after D2 gastrectomy following NAC is also unknown .


The purpose of the present study was to identify risk factors of postoperative complications after D2 surgery following NAC .


This study was conducted as an exploratory analysis of a prospective , randomized Phase II trial of NAC .


The surgical complications were assessed and classified according to the Clavien-Dindo classification .


A uni - and multivariate logistic regression analyses were performed to identify risk factors for morbidity .


Among 83 patients who were registered to the Phase II trial , 69 patients received the NAC and D2 gastrectomy .


Postoperative complications were identified in 18 patients and the overall morbidity rate was 26.1 % .


The results of univariate and multivariate analyses of various factors for overall operative morbidity , creatinine clearance ( CCr ) 60 ml/min ( P = 0.016 ) was identified as sole significant independent risk factor for overall morbidity .


Occurrence of pancreatic fistula was significantly higher in the patients with a low CCr than in those with a high CCr .


Low CCr was a significant risk factor for surgical complications in D2 gastrectomy after NAC .


Careful attention is required for these patients .


In recent years , armed conflicts in the Middle East have resulted in high rates of exposure to traumatic events .


Despite the increasing demand of mental health care provision , ongoing violence limits conventional approaches of mental health care provision .


Internet-based interventions for posttraumatic stress disorder ( PTSD ) have proved feasible and effective in Western countries , but their applicability and efficacy in war and conflict regions remains unknown .


This study investigated the efficacy of a cognitive behavioral Internet-based intervention for war-traumatized Arab patients , with focus on Iraq .


A total of 159 individuals with PTSD participated in a parallel group randomized trial .


Participants were randomly allocated by a computer-generated sequence to a treatment group ( n = 79 ) or a waiting list control group ( n = 80 ) .


The treatment group received 2 weekly 45-minute cognitive behavioral interventions via Internet over a 5-week period ( 10 sessions in total ) .


The primary outcome was recovery from posttraumatic stress symptoms .


Posttraumatic stress symptoms were significantly reduced from baseline to posttreatment ( intention-to-treat analysis ) in the treatment group relative to the control group ( F1 ,157 = 44.29 , P < .001 , d = 0.92 ) .


Treatment effects were sustained at 3-month follow-up .


Completer analysis indicated that 29 of 47 patients ( 62 % ) in the treatment group had recovered from posttraumatic stress symptoms at posttreatment ( reliable change and Posttraumatic Stress Diagnostic Scale score < 20 ) versus 1 patient ( 2 % ) in the control group ( OR 74.19 , 95 % CI 9.93-585 .8 , P < .001 ) indicating that the chance of recovering was 74.19 times higher in the treatment than in the control group .


The results indicate , even in unstable and insecure settings with ongoing exposure to human rights violations through war and dictatorships , people with posttraumatic stress symptoms benefit from a cognitive behavioral treatment provided entirely through the Internet .


This method of delivery could improve patients ' access to humanitarian aid in the form of e-mental health services .


Australian New Zealand Clinical Trial Registry , ACTRN12611001019998 ; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=347505 ( Archived by WebCite at http://www.webcitation.org/6Wto4HCdH ) .


To our knowledge , no randomized study has shown whether zinc replacement therapy is effective for hyperammonemia in liver cirrhosis ; therefore , we performed a double-blind , placebo-controlled trial to examine efficacy and safety of the zinc replacement therapy .


Patients with liver cirrhosis and hyperammonemia ( at or above the institutional reference value ) and hypozincemia ( 65 g/dL ) were enrolled in the outpatient units of the participating institutions and were randomly divided to receive placebo ( P group ) or zinc acetate preparation at a dose of 3 capsules/d for a total zinc content of 150 mg/d ( Z group ) by the envelope method .


Of the 18 enrolled patients , 6 dropped out ; thus , the analyses included 12 patients ( 5 in the P group and 7 in the Z group ) .


Variations in blood concentrations of zinc and ammonia as well as liver function test results were compared .


Blood zinc levels significantly increased in the Z group ( P = 0.0037 ; Friedman test ) but not the P group .


Blood ammonia levels significantly decreased in the Z group ( P = 0.0114 ; Friedman test ) but not the P group .


The percent change in blood ammonia level also revealed significant reduction at the eighth week in the Z group ( P = 0.0188 : Mann-Whitney test ) .


No serious adverse events attributable to the zinc preparation were noted .


Although this study is preliminary and includes a small sample , it is , to our knowledge , the first randomized controlled trial to show that zinc supplementation for 3 mo seems effective and safe for treating hyperammonemia in liver cirrhosis .


Studies with a larger sample size are needed to confirm our findings .


The relative efficiency of different eye exercise regimes is unclear , and in particular the influences of practice , placebo and the amount of effort required are rarely considered .


This study measured conventional clinical measures following different regimes in typical young adults .


A total of 156 asymptomatic young adults were directed to carry out eye exercises three times daily for 2 weeks .


Exercises were directed at improving blur responses ( accommodation ) , disparity responses ( convergence ) , both in a naturalistic relationship , convergence in excess of accommodation , accommodation in excess of convergence , and a placebo regime .


They were compared to two control groups , neither of which were given exercises , but the second of which were asked to make maximum effort during the second testing .


Instruction set and participant effort were more effective than many exercises .


Convergence exercises independent of accommodation were the most effective treatment , followed by accommodation exercises , and both regimes resulted in changes in both vergence and accommodation test responses .


Exercises targeting convergence and accommodation working together were less effective than those where they were separated .


Accommodation measures were prone to large instruction/effort effects and monocular accommodation facility was subject to large practice effects .


Separating convergence and accommodation exercises seemed more effective than exercising both systems concurrently and suggests that stimulation of accommodation and convergence may act in an additive fashion to aid responses .


Instruction/effort effects are large and should be carefully controlled if claims for the efficacy of any exercise regime are to be made .


Pulmonary coagulopathy may play a pathogenetic role in acute respiratory distress syndrome ( ARDS ) , by contributing to alveolocapillary inflammation and increased permeability .


Recombinant human activated protein C ( rh-APC ) may inhibit this process and thereby improve patient outcome .


A prospective randomized , saline-controlled , single-blinded clinical trial was performed in the intensive care units of two university hospitals , and patients with ARDS were included within 24 h after meeting inclusion criteria .


A 4-day course of intravenous rh-APC ( 24 mcg/kg/h ) ( n = 33 ) versus saline ( n = 38 ) .


The primary outcome parameter was the pulmonary leak index ( PLI ) of 67Gallium-transferrin as a measure of alveolocapillary permeability and secondary outcomes were disease severity scores and ventilator-free days , among others .


Baseline characteristics were similar ; in 87 % of patients the PLI was above normal and in 90 % mechanical or non-invasive ventilation was instituted at a median lung injury score of 2.5 .


There was no evidence that Rh-APC treatment affected the PLI or attenuated lung injury and sequential organ failure assessment scores .


Mean ventilator-free days amounted to 14 ( rh-APC ) and 12 days ( saline , P = 0.35 ) .


28-day mortality was 6 % in rh-APC - and 18 % in saline-treated patients ( P = 0.12 ) .


There was no difference in bleeding events .


The study was prematurely discontinued because rh-APC was withdrawn from the market .


There is no evidence that treatment with intravenous rh-APC during 4 days for infectious or inflammatory ARDS ameliorates increased alveolocapillary permeability or the clinical course of ARDS patients .


We can not exclude underpowering .


Nederlands Trial Register ISRCTN 52566874 .


To assess the efficacy and safety of once daily olmesartan medoxomil ( OM ) / amlodipine besylate ( AM ) / hydrochlorothiazide ( HCTZ ) 40/10/25 mg in patients with hypertension not at goal with mono , dual or triple drug therapy .


This was a single-center , prospective , open-label , blinded-endpoint study .


After a 1-week screening visit , 40 patients were enrolled into the study and given once daily treatment with OM/AM/HCTZ after the patients underwent baseline ambulatory blood pressure monitoring ( ABPM ) on their original therapy .


The primary endpoint was changes from baseline in mean 24 h ABPM [ systolic blood pressure ( SBP ) ] after the first day of therapy with OM/AM/HCTZ 40/10/25 mg .


Secondary endpoints were changes from baseline in mean 24 h ABPM [ diastolic blood pressure ( DBP ) ] after the first day of therapy with OM/AM/HCTZ 40/10/25 mg ; mean changes from baseline in trough seated SBP ( SeSBP ) at day 1 and SeSBP at weeks 1 , 2 , 3 and 4 ; mean changes from baseline in trough seated DBP ( SeDBP ) at day 1 and SeDBP at weeks 1 , 2 , 3 and 4 ; and the percentage of subjects achieving mean 24 h , daytime and night-time ABPM BP goals .


The baseline paired t-test systolic ABPM was 134.0 2.77 mmHg and day 1 was 128.6 2.47 mmHg with a treatment difference of -5.55 1.3 mmHg ( p < 0.0001 ) .


At week 1 , paired t-test ABPM SBP reduction was 117.7 2.0 mmHg with a treatment difference of -16.5 1.8 mmHg ( p < 0.0001 ) .


At week 2 , paired t-test ABPM SBP reduction was 115.8 1.8 mmHg with a treatment difference of -18.4 2.0 mmHg ( p < 0.0001 ) .


At week 3 , paired t-test ABPM SBP reduction was 115.5 1.9 mmHg with a treatment difference of -18.6 2.0 mmHg ( p < 0.0001 ) .


At week 4 , paired t-test ABPM SBP reduction was 115.5 1.8 mmHg with a treatment difference of -18.6 2.2 mmHg ( p < 0.0001 ) .


The baseline paired t-test SeSBP was 142 2.43 mmHg and day 1 was 132 2.59 mmHg with a treatment difference of -9.78 1.51 mmHg ( p < 0.0001 ) .


At week 1 , paired t-test SeSBP reduction was 124.0 1.6 mmHg with a treatment difference of -17.9 1.8 mmHg ( p < 0.0001 ) .


At week 2 , paired t-test SeSBP reduction was 120.3 1.7 mmHg with a treatment difference of -21.5 2.1 mmHg ( p < 0.0001 ) .


At week 3 , paired t-test SeSBP reduction was 118.5 1.8 mmHg with a treatment difference of -23.3 1.7 mmHg ( p < 0.0001 ) .


At week 4 , paired t-test SeSBP reduction was 119.6 1.7 mmHg with a treatment difference of -22.2 1.9 mmHg ( p < 0.0001 ) .


Treatment with OM/AM/HCTZ achieved superior ( SBP ) ABPM reductions compared with mono , dual or triple drug therapy , resulting in all patients achieving systolic ABPM goal without ABPM documented hypotension .


To examine whether sleep disturbance is associated with poor physical function in older veterans in an adult day healthcare ( ADHC ) program .


Cross-sectional .


One ADHC program in a Veterans Affairs Ambulatory Care Center .


Older veterans ( N = 50 ) enrolled in a randomized controlled trial of a sleep intervention program who had complete baseline data .


Information on participant characteristics ( e.g. , age , depression , relationship to caregiver , pain , comorbidity ) was collected using appropriate questionnaires .


Physical function was measured using activity of daily living ( ADL ) and instrumental ADL ( IADL ) total scores from the Older Americans Resources and Services Multidimensional Functional Assessment Questionnaire .


Sleep was assessed subjectively ( Pittsburgh Sleep Quality Index , Insomnia Severity Index ) and objectively ( wrist actigraphy ) .


Participants required substantial assistance with ADLs and IADLs .


A regression model showed that participant characteristics ( marital status , use of sleep medication , comorbidity , posttraumatic stress disorder ) and living arrangement ( living with a spouse or others ) were significantly associated with poor physical function .


Poorer objective sleep ( total sleep time , total numbers of awakenings , total wake time ) was significantly associated with poor physical function , accounting for a significant proportion of the variance other than participant characteristics .


Objective measures of nighttime sleep disturbance were associated with poor physical function in older veterans in an ADHC program .


Further research is needed to determine whether interventions to improve sleep will delay functional decline in this vulnerable population .


Shoulder instability is a common problem affecting young adults .


Stabilization surgery followed by physiotherapy rehabilitation has been shown to reduce the chance of further episodes of shoulder dislocation and to improve quality of life in patients who sustain a shoulder dislocation as a result of a high collision trauma , but it is unclear if surgical intervention is beneficial for patients with atraumatic shoulder instability who have structural damage at the shoulder .


The aim of this randomized controlled clinical trial is to determine if the addition of surgical intervention to physiotherapy rehabilitation improves outcomes for patients with atraumatic shoulder instability who have sustained soft tissue damage at their joint .


140 participants will be recruited .


Patients with feelings of insecurity ( apprehension ) at their shoulder joint , which is not the result of a collision injury , with physical signs of shoulder joint instability will be invited to participate .


Consenting participants will undergo arthroscopic investigation of the shoulder joint .


Patients with capsulolabral damage will be randomly allocated using a concealed allocation procedure to either stabilization surgery immediately following the arthroscopic examination or no additional surgical procedure .


All participants will then receive the same postoperative physiotherapy protocol for up to 6 months .


Outcomes ( pain , functional impairment and number of shoulder dislocations sustained ) will be evaluated prior to surgery and , together with participant-reported improvement , again at 6 , 12 and 24 months after randomization .


The primary endpoint will be pain and functional impairment at 2 years .


Participants , clinical staff ( but not surgeons ) and assessors will be blind to whether stabilization surgery was performed .


Data analysis will be conducted on an intention-to-treat basis with the focus on estimation of the effect .


This trial will have a direct and immediate impact on clinical decision making by establishing if patients presenting with soft tissue shoulder damage associated with atraumatic shoulder instability should be referred for stabilization surgery before commencing physiotherapy rehabilitation in order to ensure optimal outcome .


This in turn will ensure effective , efficient use of scarce health resources to manage this common often disabling musculoskeletal condition .


Study was registered with National Institutes of Health Clinical Trials Protocol Registration System in December 2012 .


ClinicalTrials.gov Identifier : NCT01751490 .


This study assessed the effects of two doses of glucose and a caffeine-glucose combination on mood and performance of an ecologically valid , computerised multi-tasking platform .


Following a double-blind , placebo-controlled , randomised , parallel-groups design , 150 healthy adults ( mean age 34.78 years ) consumed drinks containing placebo , 25g glucose , 60g glucose or 60g glucose with 40mg caffeine .


They completed a multi-tasking framework at baseline and then 30min following drink consumption with mood assessments immediately before and after the multi-tasking framework .


Blood glucose and salivary caffeine were co-monitored .


The caffeine-glucose group had significantly better total multi-tasking scores than the placebo or 60g glucose groups and were significantly faster at mental arithmetic tasks than either glucose drink group .


There were no significant treatment effects on mood .


Caffeine and glucose levels confirmed compliance with overnight abstinence/fasting , respectively , and followed the predicted post-drink patterns .


These data suggest that co-administration of glucose and caffeine allows greater allocation of attentional resources than placebo or glucose alone .


At present , we can not rule out the possibility that the effects are due to caffeine alone Future studies should aim at disentangling caffeine and glucose effects .


Breakfast is associated with lower body weight in observational studies .


Public health authorities commonly recommend breakfast consumption to reduce obesity , but the effectiveness of adopting these recommendations for reducing body weight is unknown .


We tested the relative effectiveness of a recommendation to eat or skip breakfast on weight loss in adults trying to lose weight in a free-living setting .


We conducted a multisite , 16-wk , 3-parallel-arm randomized controlled trial in otherwise healthy overweight and obese adults [ body mass index ( in kg/m ) between 25 and 40 ] aged 20-65 y.


Our primary outcome was weight change .


We compared weight change in a control group with weight loss in experimental groups told to eat breakfast or to skip breakfast [ no breakfast ( NB ) ] .


Randomization was stratified by prerandomization breakfast eating habits .


A total of 309 participants were randomly assigned .


A total of 283 of the 309 participants who were randomly assigned completed the intervention .


Treatment assignment did not have a significant effect on weight loss , and there was no interaction between initial breakfast eating status and treatment .


Among skippers , mean ( SD ) baseline weight - , age - , sex - , site - , and race-adjusted weight changes were -0.71 1.16 , -0.76 1.26 , and -0.61 1.18 kg for the control , breakfast , and NB groups , respectively .


Among breakfast consumers , mean ( SD ) baseline weight - , age - , sex - , site - , and race-adjusted weight changes were -0.53 1.16 , -0.59 1.06 , and -0.71 1.17 kg for the control , breakfast , and NB groups , respectively .


Self-reported compliance with the recommendation was 93.6 % for the breakfast group and 92.4 % for the NB group .


A recommendation to eat or skip breakfast for weight loss was effective at changing self-reported breakfast eating habits , but contrary to widely espoused views this had no discernable effect on weight loss in free-living adults who were attempting to lose weight .


Although blood flow-restricted low-intensity resistance training ( BFR-RT ) increases muscle size and strength in older adults , the effect of detraining on muscle adaptation is unclear .


We investigated the effects of 24weeks of detraining on thigh muscle cross-sectional area ( CSA ) and one-repetition maximum strength ( 1-RM ) in older adults who had previously participated in 12weeks of training ( BFR-RT , 20-30 % 1-RM , knee extension and leg press ) or non-BFR training .


Both 1-RM and relative dynamic strengths ( 1-RM divided by quadriceps femoris ( QF ) muscle CSA ) were higher at both post-training and detraining than at pre-training for the BFR-RT group ( p < 0.05 ) .


QF muscle CSA was higher at only post-training than at pre-training for the BFR-RT group ( p < 0.01 ) .


Increased muscle strength following 12weeks of training with BFR-RT was well preserved at 24weeks of detraining , which is due mainly to neural adaptation in older adults .


Acute radicular back pain is a frequent complaint of patients presenting to the Emergency Department .


Determine the efficacy of intravenous lidocaine when compared to ketorolac for the treatment of acute radicular low back pain .


Randomized double-blind study of 41 patients aged 18-55 years presenting with acute radicular low back pain .


Patients were randomized to receive either 100 mg lidocaine or 30 mg ketorolac intravenously over 2 min .


A 100-mm visual analog scale ( VAS ) was used to assess pain at Time 0 ( baseline ) , and 20 , 40 , and 60 minutes .


Changes in [ median ] VAS scores were compared over time ( within groups ) by the signed-rank test and between groups by the rank-sum test .


A 5-point Pain Relief Scale ( PRS ) was administered at the conclusion of the study ( 60 min ) and again at 1 week by telephone follow-up ; [ median ] scores were compared between groups by rank-sum .


Forty-four patients were recruited ; 41 completed the study ( 21 lidocaine , 20 ketorolac ) .


Initial VAS scores were not significantly different between the lidocaine and ketorolac groups ( 83 ; 95 % confidence interval [ CI ] 74-98 vs. 79 ; 95 % CI 64-94 ; p = 0.278 ) .


Median VAS scores from baseline to 60 min significantly declined in both groups ( lidocaine [ 8 ; 95 % CI 0-23 ; p = 0.003 ] ; ketorolac [ 14 ; 95 % CI 0-28 ; p = 0.007 ] ) , with no significant difference in the degree of reduction between groups ( p = 0.835 ) .


Rescue medication was required by 67 % receiving lidocaine , compared to 50 % receiving ketorolac .


No significant change in PRS between groups was found at the conclusion or at the follow-up .


Intravenous lidocaine failed to clinically alleviate the pain associated with acute radicular low back pain .


Hospitalized patients with heart failure who are malnourished present a worse prognosis than those with an adequate nutritional status .


It is unknown whether a nutritional intervention can modify the prognosis of these patients .


The aim of this study is to assess the efficacy of a nutritional intervention on morbidity and mortality in hospitalized patients with heart failure who are malnourished .


PICNIC is a multicentre , randomized , controlled trial in which hospitalized patients with heart failure and malnutrition , as defined by the Mini Nutritional Assessment , are randomly assigned to conventional management of heart failure or conventional management of heart failure and an individualized nutritional intervention consisting of 3 points : optimization of diet , specific recommendations , and prescription , if deemed necessary , of nutritional supplements .


A sample size of 182 patients for a maximum follow-up of 12 months has been estimated .


The primary endpoint is time to death from any cause or rehospitalization because of heart failure .


Analysis is by intention to treat .


PICNIC study will determine the prognostic impact of a nutritional intervention in hospitalized patients with heart failure who are malnourished .


Angioedema induced by treatment with angiotensin-converting-enzyme ( ACE ) inhibitors accounts for one third of angioedema cases in the emergency room ; it is usually manifested in the upper airway and the head and neck region .


There is no approved treatment for this potentially life-threatening condition .


In this multicenter , double-blind , double-dummy , randomized phase 2 study , we assigned patients who had ACE-inhibitor-induced angioedema of the upper aerodigestive tract to treatment with 30 mg of subcutaneous icatibant , a selective bradykinin B2 receptor antagonist , or to the current off-label standard therapy consisting of intravenous prednisolone ( 500 mg ) plus clemastine ( 2 mg ) .


The primary efficacy end point was the median time to complete resolution of edema .


All 27 patients in the per-protocol population had complete resolution of edema .


The median time to complete resolution was 8.0 hours ( interquartile range , 3.0 to 16.0 ) with icatibant as compared with 27.1 hours ( interquartile range , 20.3 to 48.0 ) with standard therapy ( P = 0.002 ) .


Three patients receiving standard therapy required rescue intervention with icatibant and prednisolone ; 1 patient required tracheotomy .


Significantly more patients in the icatibant group than in the standard-therapy group had complete resolution of edema within 4 hours after treatment ( 5 of 13 vs. 0 of 14 , P = 0.02 ) .


The median time to the onset of symptom relief ( according to a composite investigator-assessed symptom score ) was significantly shorter with icatibant than with standard therapy ( 2.0 hours vs. 11.7 hours , P = 0.03 ) .


The results were similar when patient-assessed symptom scores were used .


Among patients with ACE-inhibitor-induced angioedema , the time to complete resolution of edema was significantly shorter with icatibant than with combination therapy with a glucocorticoid and an antihistamine .


( Funded by Shire and the Federal Ministry of Education and Research of Germany ; ClinicalTrials.gov number , NCT01154361 . )


Deep brain stimulation ( DBS ) of the globus pallidus internus is an effective treatment for cervical dystonia ( CD ) .


Interestingly , the onset of initial DBS effects is significantly prolonged compared with that in other diseases , such as Parkinson 's disease .


The return of symptoms after cessation of DBS could be delayed as well , but this has not been studied systematically .


In patients who were treated for CD using DBS and had a good treatment effect , we compared interruption of DBS with sham-OFF in a randomized , double-blind crossover trial .


We observed that dystonic features appeared within a few minutes at almost full intensity in all patients after the cessation of DBS .


The almost immediate onset of dystonic features in our sample seems to exclude mechanisms with long time constants from the pathophysiology of dystonia .


Thus , it is likely that , in these patients , an aberrant pattern of neural activity representing an inappropriate set point value for the position of the head is responsible for dystonia .


Adequate biomarkers for the dietary supply of fatty acids ( FA ) are FA of adipose tissue and blood fractions .


In human studies , invasive sample collection is unpleasant for subjects .


In contrast , cheek cell sampling can be considered as a non-invasive alternative to investigate FA status.The aim of this study was to analyze whether cheek cell FA composition reflect the supplementation of alpha-linolenic acid ( ALA ) using a linseed oil mixture compared to olive oil supplementation .


Additionally , it was investigated if cheek cell FA composition correlates with the FA composition of plasma , red blood cells ( RBC ) and peripheral blood mononuclear cells ( PBMC ) before and during both interventions .


During a 10-week randomized , controlled , double-blind human intervention study , 38 subjects provided cheek cell and blood samples .


After a two-week run-in period , the test group ( n = 23 ) received 17 g/d of an ALA-rich linseed oil mixture , while the control group ( n = 15 ) received 17 g/d of an omega-3 ( n-3 ) polyunsaturated FA ( PUFA ) - free olive oil .


Cheek cells and blood were collected on days 0 , 7 and 56 of the 8-week intervention period .


Compared to olive oil , the linseed oil intervention increased ALA and also the endogenously converted long-chain n-3 metabolites eicosatetraenoic - , eicosapentaenoic - and docosapentaenoic acid in cheek cells ( P0 .05 ) .


Docosahexaenoic acid remained unchanged .


Reflecting the treatment , the n-6 / n-3 ratio decreased in the test group .


In general , cheek cell FA reflected the changes of FA in blood fractions .


Independent of treatment , significant correlations ( P0 .05 ) of n-6 PUFA and n-3 PUFA between cheek cells and plasma , RBC and PBMC were found , except for linoleic acid and ALA. .


The changes in FA composition of cheek cells confirmed that ALA from linseed oil increased endogenously derived n-3 PUFA in cheek cell lipids .


These changes in cheek cells and their correlation to the respective FA in blood fractions indicate the cheek cell FA profile as an adequate non-invasive biomarker for short-term n-3 PUFA intake and metabolism .


Therefore , cheek cell FA can be used in human intervention studies or large-scale epidemiological studies , especially for assessment of the n-3 PUFA status .


ClinicalTrials.gov , IDNCT01317290 .


Iron supplementation for hypoferremic anemia could potentiate bacterial growth in the cystic fibrosis ( CF ) lung , but clinical trials testing this hypothesis are lacking .


Twenty-two adults with CF and hypoferremic anemia participated in a randomized , double-blind , placebo-controlled , crossover trial of ferrous sulfate 325mg daily for 6weeks .


Iron-related hematologic parameters , anthropometric data , sputum iron , Akron Pulmonary Exacerbation Score ( PES ) , and the sputum microbiome were serially assessed .


Fixed-effect models were used to describe how ferrous sulfate affected these variables .


Ferrous sulfate increased serum iron by 22.3 % and transferrin saturation ( TSAT ) by 26.8 % from baseline ( p < 0.05 ) but did not affect hemoglobin , sputum iron , Akron PES , and the sputum microbiome .


Low-dose ferrous sulfate improved hypoferremia without correcting anemia after 6weeks .


We did not observe significant effects on sputum iron , Akron PES , and the sputum microbiome .


Although we did not identify untoward health effects of iron supplementation , a larger blinded randomized controlled trial would be needed to fully demonstrate safety .


Although totally implantable venous access devices ( TIVAD ) are increasingly being used in oncology patients , more robust evidence about the best technique is lacking , especially regarding to ultrasound ( US ) guided puncture .


One hundred ten patients with indication of intravenous chemotherapy were randomly assigned to TIVAD implant through US-guided internal jugular vein ( USG ) puncture ( 39 ) or internal jugular vein blindly ( IJB ) ( 36 ) or subclavian vein blindly ( SCB ) ( 35 ) .


Procedure data and complications were prospectively recorded within 30 days of the procedure .


All patients completed the follow up .


Immediate complication rate was 5.1 % , 13.9 % , and 0 % in the USG , IJB , and SCB groups , respectively ( P = 0.05 ) .


First attempt success rate was 79.5 % in the USG , 52.8 % in the IJB and 47.2 % in the SCB group ( P = 0.012 ) .


Technique failure was observed in 2.6 % , 22.2 % , and 8.6 % of the population in the USG , IJB , and SCB , respectively ( P = 0.021 ) .


Early complication rate was 5.1 % in USG group , 2.8 % in the IJB , and 0 % in the SCB ( P = 0.401 ) .


The findings of our study suggest superiority of the USG approach in terms of first puncture success rate and technique failure , without increasing the procedure duration .


Long-term follow-up results should help to further clarify the current debates .


Many studies have examined laser treatment of scars , but cosmetic results have been variable .


Although no studies have examined the effect of purpura on scar improvement using the pulsed dye laser ( PDL ) , many clinicians believe inducing purpura results in better and quicker improvement .


To determine whether PDL treatment of fresh surgical scars with purpura-inducing settings improves clinical appearance more than non-purpura-inducing settings or no treatment .


Twenty-six subjects with surgical scars enrolled in this prospective study .


Scars were divided into three equal segments ; treatment was randomized : 595-nm PDL with purpuric ( 1.5 ms ) or nonpurpuric ( 10ms ) settings or no treatment .


Fluences were adjusted to Fitzpatrick skin type .


Scars were treated three times , 1month apart , beginning at suture removal .


Outcome measures included Vancouver Scar Scale ( VSS ) and blind clinical ratings .


The nonpurpuric condition showed significant improvement on the VSS total score , vascularity , and pliability ratings .


The purpuric condition demonstrated a trend for improvement on the VSS total .


According to blind observer ratings , all conditions improved , without differences between groups .


Nonpurpuric settings on the PDL resulted in significant improvements in the appearance of fresh surgical scars for vascularity , pliability , and VSS total scores , although all scar segments improved over time .


Persistent weakness is a common problem after anterior cruciate ligament - ( ACL - ) reconstruction .


This study investigated the effects of high-intensity ( HRT ) versus low-intensity ( LRT ) resistance training on leg extensor power and recovery of knee function after ACL-reconstruction .


31 males and 19 females were randomized to HRT ( n = 24 ) or LRT ( n = 26 ) from week 8-20 after ACL-reconstruction .


Leg extensor power , joint laxity , and self-reported knee function were measured before and 7 , 14 , and 20 weeks after surgery .


Hop tests were assessed before and after 20 weeks .


Power in the injured leg was 90 % ( 95 % CI 86-94 % ) of the noninjured leg , decreasing to 64 % ( 95 % CI 60-69 % ) 7 weeks after surgery .


During the resistance training phase there was a significant group by time interaction for power ( P = 0.020 ) .


Power was regained more with HRT compared to LRT at week 14 ( 84 % versus 73 % of noninjured leg , resp. ; P = 0.027 ) and at week 20 ( 98 % versus 83 % of noninjured leg , resp. ; P = 0.006 ) without adverse effects on joint laxity .


No other between-group differences were found .


High-intensity resistance training during rehabilitation after ACL-reconstruction can improve muscle power without adverse effects on joint laxity .


Functional electrical stimulation ( FES ) to patients early after stroke has been proved to improve walking ability .


The effects on abilities in activities of daily living ( ADL ) are not clear .


To investigate the effectiveness of FES in improving lower limb function and ability in ADL of early stroke patients .


Thirty-seven stroke patients were randomly allocated to standard rehabilitation ( SR ) group ( n = 18 ) , and FES group with FES and SR ( n = 19 ) .


SR included 60 minutes each for physiotherapy and occupational therapy .


FES was delivered for 30 min to induce ankle dorsiflexion and eversion .


Treatments were 5 days per week for 3 weeks .


Evaluations including the composite spasticity scale ( CSS ) , lower-extremity subscale of Fugl-Myer Assessment ( FMA ) , postural assessment scale for stroke patients ( PASS ) , Berg Balance Scale ( BBS ) , and modified Barthel Index ( MBI ) assessed before treatment , after 2 and 3 week treatment respectively .


After 2 week treatment , FES group showed a significant reduction of CSS and improvements of FMA , MBI and PASS .


After 3 week treatment , FES group showed a further reduction of CSS and also improvement of FMA , MBI and BBS as well .


FES on the paretic lower limbs early after stroke improved the mobility and ability in ADL .


The role of bleomycin and dacarbazine in the ABVD regimen ( ie , doxorubicin , bleomycin , vinblastine , and dacarbazine ) has been questioned , especially for treatment of early-stage favourable Hodgkin 's lymphoma , because of the drugs ' toxicity .


We aimed to investigate whether omission of either bleomycin or dacarbazine , or both , from ABVD reduced the efficacy of this regimen in treatment of Hodgkin 's lymphoma .


In this open-label , randomised , multicentre trial ( HD13 ) we compared two cycles of ABVD with two cycles of the reduced-intensity regimen variants ABV ( doxorubicin , bleomycin , and vinblastine ) , AVD ( doxorubicin , vinblastine , and dacarbazine ) , and AV ( doxorubicin and vinblastine ) , in patients with newly diagnosed , histologically proven , classic or nodular , lymphocyte predominant Hodgkin 's lymphoma .


In each treatment group , 30 Gy involved-field radiotherapy ( IFRT ) was given after both cycles of chemotherapy were completed .


From Jan 28 , 2003 , patients were centrally randomly assigned ( 1:1:1:1 ) with a minimisation method to the four groups .


Because of high event rates , assignment to the AV and ABV groups stopped early , on Sept 30 , 2005 , and Feb 10 , 2006 ; assignment to ABVD and AVD continued ( 1:1 ) until Sept 30 , 2009 .


Our primary objective was to show non-inferiority of the experimental variants compared with ABVD in terms of freedom from treatment failure ( FFTF ) , by excluding a difference of 6 % after 5 years corresponding to a hazard ratio ( HR ) of 1.72 , via a 95 % CI .


Analyses reported here include qualified patients only , and between-group comparisons include only patients recruited during the same period .


The trial was registered , number ISRCTN63474366 .


Of 1502 qualified patients , 566 , 198 , 571 , and 167 were randomly assigned to receive ABVD , ABV , AVD , or AV , respectively .


5 year FFTF was 93.1 % , 81.4 % , 89.2 % , and 77.1 % with ABVD , ABV , AVD , and AV , respectively .


Compared with ABVD , inferiority of the dacarbazine-deleted variants was detected with 5 year differences of -11.5 % ( 95 % CI -18.3 to -4.7 ; HR 2.06 [ 1.21 to 3.52 ] ) for ABV and -15.2 % ( -23.0 to -7.4 ; HR 2.57 [ 1.51 to 4.40 ] ) for AV .


Non-inferiority of AVD compared with ABVD could also not be detected ( 5 year difference -3.9 % , -7.7 to -01 ; HR 1.50 , 1.00 to 2.26 ) .


178 ( 33 % ) of 544 patients given ABVD had WHO grade III or IV toxicity , compared with 53 ( 28 % ) of 187 given ABV , 142 ( 26 % ) of 539 given AVD , and 40 ( 26 % ) of 151 given AV .


Leucopenia was the most common event , and highest in the groups given bleomycin .


Dacarbazine can not be omitted from ABVD without a substantial loss of efficacy .


With respect to our predefined non-inferiority margin , bleomycin can not be safely omitted either , and the standard of care for patients with early-stage favourable Hodgkin 's lymphoma should remain ABVD followed by IFRT .


Deutsche Krebshilfe and Swiss State Secretariat for Education and Research .


To assess the potential of a stabilised stannous ( Sn ) - containing NaF dentifrice ( Oral B/blend-a-Med ( ) Pro-Expert ) , in addition to a number of other marketed European dentifrices formulated with various fluoride actives and two control dentifrices , to protect enamel against erosive acid damage .


Cores of human enamel ( four per group ) were soaked in pooled human saliva , and then treated with a 1:3 slurry ( dentifrice : saliva ) using a standardised in vitro erosion model ( 5-day cycling ) that includes 10-minute challenges with 1 % citric acid applied 60 minutes after each dentifrice treatment .


Enamel surface loss was measured using transverse microradiography ( TMR ) .


Specimens treated with the Sn-containing NaF dentifrice showed 6.5 m of surface loss 1.2 ( SEM ) , which was not significantly different ( P < 0.05 , Fisher LSD ) from that of a clinically proven , stabilised SnF2 positive control [ Crest ( ) Pro-Health , 1,100 ppm F as SnF2 : 3.0 m of surface loss 1.1 ( SEM ) ] .


The Sn-containing NaF dentifrice and the clinically proven positive control both provided significantly greater protection ( P < 0.05 , Fisher LSD ) compared with all of the other products tested .


Enamel loss ( SEM ) values for other European products and the reference control ( active agents ) were : Meridol ( ) : ( 1,400 ppm F as AmF + SnF2 ) 12.0 m ( 1.47 ) ; Colgate ( ) Cavity Protection : ( 1,450 ppm F as SMFP + NaF ) 12.9 m ( 1.66 ) ; Odol med 3 ( ) ( 1,400 ppm F as NaF ) 14.2 m ( 1.49 ) ; Elmex ( ) ( 1,400 ppm F as AmF ) 14.5 m ( 1.76 ) ; Colgate ( ) Enamel Protect : ( 1,450 ppm F as NaF + KNO3 ) 16.3 m ( 2.02 ) ; Lacalut ( ) aktiv : ( 1,400 ppm F as AlF3 ) 18.5 m ( 1.71 ) ; Sensodyne ( ) ProNamel ( ) : ( 1,450 ppm F as NaF + KNO3 ) 20.5 m ( 1.26 ) ; Crest Cavity Protection ( 1,100 ppm F as NaF , reference control ) 22.00 m ( 2.04 ) ; and Mentadent ( ) : ( 1,450 ppm F as NaF + Zn citrate ) 22.3 m ( 0.63 ) .


These results support the potential for the stabilised , Sn-containing NaF dentifrice to provide erosion protection benefits that are not significantly different from the positive control benchmark for erosion protection ( stabilised SnF2 ) , and are significantly better than a broad range of dentifrice formulations available on the European market .


To verify the efficacy to obtain mydriasis and cardiovascular safety of Mydriasert ( ophthalmic insert containing tropicamide and phenylephrine ) in diabetic and nondiabetic patients undergoing retinal angiography by comparing it with usually administered eyedrops ( tropicamide 1 % and phenylephrine 10 % ) .


This was a prospective randomized study .


A total of 154 eyes of 77 patients were randomly divided into 2 groups : group 1 consisted of 78 eyes , group 2 consisted of 76 eyes , and the patients were monitored for pupillary dilation , blood pressure , heart rate , and possible adverse effects at 0 , 20 , 40 , 60 , and 90 minutes .


No severe adverse effects were observed in either group .


In the entire sample studied , the mean pupillary diameter was greater in the eyedrops group after 20 and 40 minutes , while mydriasis was similar in the 2 groups after 60 minutes .


The diabetic patients treated with Mydriasert had less mydriasis than those treated with eyedrops after 20 and 40 minutes , and diabetic patients showed less mydriasis than the nondiabetic patients after 60 and 90 minutes .


There was no significant between-group difference in mean heart rate or systolic and diastolic blood pressure at any of the time points .


Mydriasert assures an adequate degree of mydriasis for retinal angiography in both diabetic and nondiabetic patients .


There are no differences in efficacy or safety between the insert and the usually administered eyedrops , but the low total drug dose administered with the insert reduces the risk of cardiovascular side effects .


The purpose of this study was to assess the impact of a mental illness self-management intervention , called Wellness Recovery Action Planning ( WRAP ) , on the use of and need for mental health services over time compared with nutrition and wellness education .


Participants were recruited from outpatient community mental health settings in Chicago , Illinois .


Using a single-blind , randomized controlled trial design , 143 individuals were assigned to WRAP or to a nutrition education course and assessed at baseline and at 2-month and 8-month follow-up .


The WRAP intervention was delivered by peers in recovery from serious mental illness who were certified WRAP educators over nine weekly sessions lasting 2.5 hrs .


The nutrition education curriculum was taught by trained non-peer educators using the same schedule .


Mixed-effects random regression analysis tested for differences between the two interventions in ( a ) self-reported use of 19 clinical , rehabilitation , peer , emergent , and ancillary services ; and ( b ) self-reported need for these services .


Results of mixed-effects random regression analysis indicated that , compared with controls , WRAP participants reported significantly greater reduction over time in service utilization ( total , individual , and group ) , and service need ( total and group services ) .


Participants in both interventions improved significantly over time in symptoms and recovery outcomes .


Training in mental illness self-management reduced the self-reported need for and use of formal mental health services over time .


This confirms the importance of WRAP in an era of dwindling behavioral health service availability and access .


Virologic failure following treatment of hepatitis C virus ( HCV ) genotype 1 with direct-acting antiviral agents is often accompanied by the emergence of resistant variants .


MK-5172 is an investigational once-daily protease inhibitor .


We analyzed variants in treatment-naive noncirrhotic patients with virologic failure on MK-5172 ( 100-800 mg/day ) plus pegylated interferon alfa/ribavirin ( peg-IFN/RBV ) during a phase 2 trial .


Population and selective clonal sequencing were performed at baseline and at virologic failure in the 4 MK-5172 dosing arms .


MK-5172 activity was determined using a mutant replicon assay .


Six of 266 ( 2.3 % ) MK-5172 recipients satisfied prespecified criteria for virologic failure , all with genotype 1a infection .


Five patients with virologic failure were in the MK-5172 100-mg arm , including 4 patients with low plasma MK-5172 levels documented during triple therapy .


Variants associated with > 4-fold loss of potency were detected in 3 of the 4 patients with genotype 1a breakthrough while on MK-5172 .


The fifth patient had undetectable HCV-RNA levels at the end of triple therapy but subsequently broke through during the peg-IFN/RBV tail 16 weeks after completion of MK-5172 .


Three patients had D168 variants at virologic failure , including 2 with the D168A variant associated with a 95-fold loss of potency .


The sole apparent relapse was actually a genotype 3a reinfection in the MK-5172 200-mg group .


Virologic failure occurred uncommonly ( 6/266 [ 2.3 % ] ) in MK-5172 / peg-IFN/RBV recipients .


The most prevalent treatment-emergent variants were detected at the D168 locus .


D168A variants conferring approximately 2-log reduction in MK-5172 susceptibility emerged in 2 of the 4 evaluable patients with genotype 1a breakthrough .


Clinical Trials Registration.NCT01353911 .


This study aimed to determine the effect of cumin powder on body composition and lipid profile in overweight and obese women .


In this randomized clinical trial , 88 overweight/obese women were randomly assigned into two groups .


The experimental group was asked to have 3g/d cumin powder with yogurt at two meals for 3 months .


The same amount of yogurt minus cumin powder was prescribed for the control group .


All patients received nutrition counseling for weight loss in a similar manner .


Anthropometric and biochemical parameters were determined before and after the intervention .


Cumin powder reduced serum levels of fasting cholesterol , triglyceride , and LDL and increased HDL .


Weight , BMI , waist circumference , fat mass and its percentage significantly reduced .


It has no effect on FBS and fat-free mass .


Cumin powder in a weight reduction diet showed improvement in anthropometric and biochemical parameters in overweight/obese women .


Premature infants are at risk of developing encephalopathy of prematurity , which is associated with long-term neurodevelopmental delay .


Erythropoietin was shown to be neuroprotective in experimental and retrospective clinical studies .


To determine if there is an association between early high-dose recombinant human erythropoietin treatment in preterm infants and biomarkers of encephalopathy of prematurity on magnetic resonance imaging ( MRI ) at term-equivalent age .


A total of 495 infants were included in a randomized , double-blind , placebo-controlled study conducted in Switzerland between 2005 and 2012 .


In a nonrandomized subset of 165 infants ( n = 77 erythropoietin ; n = 88 placebo ) , brain abnormalities were evaluated on MRI acquired at term-equivalent age .


Participants were randomly assigned to receive recombinant human erythropoietin ( 3000 IU/kg ; n = 256 ) or placebo ( n = 239 ) intravenously before 3 hours , at 12 to 18 hours , and at 36 to 42 hours after birth .


The primary outcome of the trial , neurodevelopment at 24 months , has not yet been assessed .


The secondary outcome , white matter disease of the preterm infant , was semiquantitatively assessed from MRI at term-equivalent age based on an established scoring method .


The resulting white matter injury and gray matter injury scores were categorized as normal or abnormal according to thresholds established in the literature by correlation with neurodevelopmental outcome .


At term-equivalent age , compared with untreated controls , fewer infants treated with recombinant human erythropoietin had abnormal scores for white matter injury ( 22 % [ 17/77 ] vs 36 % [ 32/88 ] ; adjusted risk ratio [ RR ] , 0.58 ; 95 % CI , 0.35-0 .96 ) , white matter signal intensity ( 3 % [ 2/77 ] vs 11 % [ 10/88 ] ; adjusted RR , 0.20 ; 95 % CI , 0.05-0 .90 ) , periventricular white matter loss ( 18 % [ 14/77 ] vs 33 % [ 29/88 ] ; adjusted RR , 0.53 ; 95 % CI , 0.30-0 .92 ) , and gray matter injury ( 7 % [ 5/77 ] vs 19 % [ 17/88 ] ; adjusted RR , 0.34 ; 95 % CI , 0.13-0 .89 ) .


In an analysis of secondary outcomes of a randomized clinical trial of preterm infants , high-dose erythropoietin treatment within 42 hours after birth was associated with a reduced risk of brain injury on MRI .


These findings require assessment in a randomized trial designed primarily to assess this outcome as well as investigation of the association with neurodevelopmental outcomes .


clinicaltrials.gov Identifier : NCT00413946 .


This study compared the effect of superior and inferior joint space injections of hyaluronic acid ( HA ) and evaluated osteoarthritic changes in patients diagnosed with temporomandibular joint ( TMJ ) anterior disc displacement without reduction ( ADDw/oR ) in association with osteoarthritis ( OA ) by cone-beam computed tomography ( CBCT ) .


One hundred forty-one patients with research diagnostic criteria for ADDw/oR in association with TMJ OA were randomly assigned to 1 of 2 study groups that received superior or inferior joint space injection of HA .


CBCT and clinical examination were performed before treatment and at 3 and 9 months after treatment .


One hundred twenty-six patients returned for the 3-month evaluations , and 74 returned for the 9-month evaluations .


Condylar remodeling and TMJ function showed improvement in most patients after treatment .


At 3 months , remodeling scores in the superior and inferior groups were 2.14 3.16 and 4.08 3.82 , respectively , and scores were 4.80 3.36 and 7.47 3.90 at 9 months .


There were significant differences between the superior and inferior groups at 3 and 9 months after treatment ( 3-month , P = .002 ; 9-month , P = .002 ) .


The Helkimo index of the inferior group was significantly lower than that of superior group at 3 and 9 months ( 3-month , P = .008 ; 9-month , P = .028 ) .


There were no significant differences in maximal mouth opening between the 2 groups at 3 and 9 months ( 3-month , P = .82 ; 9-month , P = .20 ) .


Superior and inferior joint space injections of HA are effective methods for the treatment of ADDw/oR in association with TMJ OA .


The injection of HA within the inferior joint space appears to result in better condylar reparative remodeling and improvement in jaw function .


To examine whether an Internet-based learning module and small-group debriefing can improve medical trainees ' attitudes and communication skills toward patients with substance use disorders ( SUDs ) .


In 2011-2012 , 129 internal and family medicine residents and 370 medical students at two medical schools participated in a cluster randomized controlled trial , which assessed the effect of adding a two-part intervention to the SUDs curricula .


The intervention included a self-directed , media-rich Internet-based learning module and a small-group , faculty-led debriefing .


Primary study outcomes were changes in self-assessed attitudes in the intervention group ( I-group ) compared with those in the control group ( C-group ) ( i.e. , a difference of differences ) .


For residents , the authors used real-time , Web-based interviews of standardized patients to assess changes in communication skills .


Statistical analyses , conducted separately for residents and students , included hierarchical linear modeling , adjusted for site , participant type , cluster , and individual scores at baseline .


The authors found no significant differences between the I - and C-groups in attitudes for residents or students at baseline .


Compared with those in the C-group , residents , but not students , in the I-group had more positive attitudes toward treatment efficacy and self-efficacy at follow-up ( P < .006 ) .


Likewise , compared with residents in the C-group , residents in the I-group received higher scores on screening and counseling skills during the standardized patient interview at follow-up ( P = .0009 ) .


This intervention produced improved attitudes and communication skills toward patients with SUDs among residents .


Enhanced attitudes and skills may result in improved care for these patients .


Malaria remains a major public health problem in developing countries .


Then in these countries prompt access to effective antimalarial treatment such as Artemisinin based-Combination Therapies ( ACT ) proves to be an essential tool for controlling the disease .


In Senegal , since 2006 a nationwide scaling up program of ACT is being implemented .


In this context it has become relevant to monitor ACT efficacy and provide recommendations for the Senegalese national malaria control program .


An open randomized trial was conducted during two malaria transmission seasons ( 2011 and 2012 ) to assess the efficacy and safety of three combinations : dihydro-artemisinin-piperaquine ( DHAPQ ) , artemether-lumefantrine ( AL ) and artesunate-amodiaquine ( ASAQ ) .


The primary end point of the study was represented by a PCR adjusted adequate clinical and parasitological response ( ACPR ) at day 28 .


Secondary end points included : ( i ) a ACPR at days 35 and 42 , ( ii ) a parasite and fever clearance time , ( iii ) ACTs safety and tolerability .


The 2003 WHO 's protocol for antimalarial drug evaluation was used to assess each outcome .


Overall , 534 patients were randomized selected to receive , either ASAQ ( n = 180 ) , AL ( n = 178 ) or DHAPQ ( n = 176 ) .


The PCR adjusted ACPR at day 28 was 99.41 % for the group ASAQ , while that was 100 % in the AL and DHAPQ groups ( p = 0.37 ) .


The therapeutic efficacy was evaluated at 99.37 % in the ASAQ arm versus 100 % in AL and DHAPQ arm at day 35 ( p = 0.37 ) .


At day 42 , the ACPR was 99.27 % in the ASAQ group versus 100 % for both AL and DHAPQ groups , ( p = 0.36 ) .


No serious adverse event was noted during the study period .


Also a similar safety profile was noted in the 3 study groups .


In the context of scaling up of ACTs in Senegal , ASAQ , AL and DHAPQ are highly effective and safe antimalarial drugs .


However , it 's remains important to continue to monitor their efficacy .


PACTR 201305000552290 .


To assess the response of soft tissues around two different abutment designs in healed sites in the esthetic zone .


Twenty-six subjects received two endosseous implants in healed , bilateral implant sites in the esthetic zone in the maxilla or the mandible .


After 17 to 19 weeks and left/right randomization , the implants were restored with either a conventional ( control ) or curved ( experimental ) titanium abutment and a provisional crown .


Eight weeks after abutment placement , definitive crowns were cemented ( T0 ) .


Soft tissue development was assessed based on peri-implant bone loss , Pink Esthetic Score ( PES ) , and probing depths immediately after placement of the definitive crown and after 1 year ( T12 ) and compared between sites .


Possible confounding variables ( abutment angle , plaque presence , gingival bleeding , width of attached mucosa ) were also documented at T0 and T12 .


The mean peri-implant marginal bone loss from T0 to T12 was 0.00 0.37 mm in the experimental group and 0.12 0.27 mm in the control group .


Differences were not statistically significant ( P = .25 ) .


At T12 , the curved abutment scored a mean PES of 10 2.3 and the straight abutment scored 9.7 2.3 .


The difference was not significant ( P = .46 ) ) .


Probing depths were also not significantly different between the two groups ( P = .85 ) .


Correlation and regression analysis showed no hints of predictive behavior for the possible confounding variables .


A titanium abutment with a circumferential curved design is of no additional benefit to soft tissue development and preservation of marginal bone compared to a conventional straight abutment design for the restoration of single-tooth implants in the esthetic zone .


To investigate the effect of postoperative early oral feeding on humoral immune function and clinical outcome in colorectal cancer patients .


Seventy patients with colorectal carcinoma requiring elective colorectal resection were prospectively enrolled and randomized into two groups : early oral feeding group ( n = 35 ) and conventional oral feeding group ( n = 35 ) .


The patients in early oral feeding group were started on oral feeding within 12 hours after operation , while patients in conventional group were started on oral feeding after the postoperative first passage of flatus .


Postoperative parameters of clinic and humeral immune function were compared between two groups .


Sixty-two patients eventually completed the study , including 32 cases in early oral feeding group and 30 cases in conventional oral feeding group .


The average time to first passage of flatus [ ( 21 ) d vs. ( 42 ) d , P < 0.01 ] , the first passage of stool [ ( 3.81.6 ) d vs. ( 6.42.5 ) d , P < 0.01 ] , resumption of regular diet [ ( 42 ) d vs. ( 8.22.2 ) d , P < 0.01 ] and the postoperative hospital stay [ ( 61 ) d vs. ( 11.73.8 ) d , P < 0.01 ] were significantly shorter in early oral feeding group as compared to conventional oral feeding group .


Significantly faster recovery of postoperative humoral immunity was found .


Plasma levels of globulin [ ( 24.12.4 ) g/L vs. ( 22.13.3 ) g/L , P < 0.05 ] , immunoglobulin G [ ( 10.82.4 ) g/L vs. ( 8.72.1 ) g/L , P < 0.01 ] and complement 4 [ ( 0.240.09 ) g/L vs. ( 0.170.05 ) g/L , P < 0.05 ] on postoperative day 3 were higher in early oral feeding group as compared to conventional oral feeding group .


Application of postoperative early oral feeding in patients undergoing elective colorectal resection is safe and effective , which can lead to faster recovery of postoperative humoral immune function and bowel function , and shorter postoperative hospital stay .


It is known that static stretching is an appropriate means of increasing the range of motion , but information in the literature about the mechanical adaptation of the muscle-tendon unit is scarce .


Therefore , the purpose of this study was to investigate the influence of a six-week static stretching training program on the structural and functional parameters of the human gastrocnemius medialis muscle and the Achilles tendon .


A total of 49 volunteers were randomly assigned into static stretching and control groups .


Before and following the stretching intervention , we determined the maximum dorsiflexion range of motion with the corresponding fascicle length and pennation angle .


Passive resistive torque and maximum voluntary contraction were measured with a dynamometer .


Muscle-tendon junction displacement allowed us to determine the length changes in tendon and muscle , and hence to calculate stiffness .


Fascicle length , pennation angle , and muscle tendon junction displacement were measured with ultrasound .


Mean range of motion increased significantly from 30.9 ( 5.3 ) to 36.3 ( 6.1 ) in the intervention group , but other functional ( passive resistive torque , maximum voluntary contraction ) and structural ( fascicle length , pennation angle , muscle stiffness , tendon stiffness ) parameters were unaltered .


The increased range of motion could not be explained by the structural changes in the muscle-tendon unit , and was likely due to increased stretch tolerance possibly due to adaptations of nociceptive nerve endings .


Melasma is a dermatosis with significant repercussions on patients ' quality of life , and there is currently no standard treatment .


Hydroquinone is deemed the treatment of choice , but its safety has been questioned in certain cases .


To determine the efficacy and safety of a new combination of retinoids in the improvement of melasma .


Prospective , double-blind , vehicle-controlled , and randomized study in 30 patients with melasma .


The product was applied on one side of the face and the vehicle on the other , twice daily during 3months .


Standardized photographs were taken using RBX technology on the three visits ( basal , at one and a half months and at 3months ) .


The main variable to determine the efficacy was the improvement of the hemifacial Melasma Area Severity Index ( MASI ) .


Other variables were determined such as improvement perceived by the investigator , improvement perceived by the patient , impact on quality of life or side effects .


The MASI improvement at 3months of treatment was significant on the treated side vs. the vehicle side , reaching an improvement of 70 % , which is comparable to the percentage of improvement described with hydroquinone .


No notable side effects were detected , in spite of a significant percentage of patients included in the study citing a history that could be compatible with sensitive skin .


This new combination of retinoids and depigmenting agents proved to be effective and safe in the treatment of melasma .


A common variant rs236918 in the PCSK7 gene has the strongest association with iron homeostasis and is related to insulin resistance .


Dietary carbohydrate ( CHO ) modulates the genetic effect on insulin resistance .


We examined whether 2-year weight-loss diets modify the effect of PCSK7 genetic variants on changes in fasting insulin levels and insulin resistance in a randomized , controlled trial .


Data were analyzed in the Preventing Overweight Using Novel Dietary Strategies ( POUNDS LOST ) trial , which is a randomized , controlled 2-year weight-loss trial using diets that differed in macronutrient proportions .


PCSK7 rs236918 was genotyped in 730 overweight or obese adults ( 80 % whites ) in this trial .


We assessed the progression in fasting insulin and glucose levels , and insulin resistance by genotypes .


During the 6-month weight-loss phase , the PCSK7 rs236918 G allele was significantly associated with greater decreases in fasting insulin levels in the high-dietary CHO group ( P for interaction = 0.04 ) , while the interaction for changes in HOMA-insulin resistance ( HOMA-IR ) ( P for interaction = 0.06 ) did not reach significant levels in white subjects .


The G allele was significantly associated with a greater decrease in fasting insulin levels and HOMA-IR in response to high dietary CHO levels ( P = 0.02 and P = 0.03 , respectively ) .


From 6 months to 2 years ( weight-regain phase ) , the interactions became attenuated due to the regaining of weight ( P for interactions = 0.08 and 0.06 , respectively ) .


In addition , we observed similar and even stronger results in the whole-study samples from the trial .


Our data suggest that PCSK7 genotypes may interact with dietary CHO intake on changes in insulin sensitivity in the white Americans .


To assess the use of a hydrogel ocular bandage ( HOB ) on clear corneal incisions in phacoemulsification cataract surgery and determine whether HOB reduces ocular surface contaminants ingress after routine surgery .


In this prospective randomized controlled study , thirty eyes of patients undergoing uneventful phacoemulsification were recruited consecutively and randomly assigned to have a HOB applied to the corneal incision at the end of the surgery or not .


At the end of the surgery , trypan blue ( TRB ) was instilled on the ocular surface , aqueous fluid was aspirated from the anterior chamber ( AC ) and its optical density was measured using ultraviolet spectrophotometry .


The corneal incisions were examined postoperatively using anterior segment optical coherence tomography .


Main outcome measures were concentration of TRB in the AC , corneal incision architecture , intraocular pressure ( IOP ) and Seidel test .


All incisions were Seidel negative .


The mean IOP in the immediate postoperative period was 18.1 5.48 mmHg for the intervention group and 16.9 5.7 mmHg for the control group ( p > 0.05 ) .


No architectural differences of the incisions between the two groups were noted .


The total mean length of the three-step corneal incisions in the two groups was 2261.2 96.92 m and 2263 119.75 m , respectively ( p > 0.05 ) .


No trace of TRB was detected in any of the samples .


Proper surgical wound construction without the use of a HOB is efficient in preventing the ingress of fluid through the main corneal incision postoperatively .


Concurrent administration of dopamine and serotonin reuptake inhibitors reduces cocaine self-administration in monkeys .


Consonant with this , clinical trials assessing modafinil and selective serotonin reuptake inhibitors alone show some efficacy as potential pharmacotherapies for cocaine dependence .


We hypothesized that combining modafinil with escitalopram would attenuate the euphoric effects of cocaine to a greater degree than modafinil alone .