Improved therapeutic adherence ( observed in both groups combined ) was positively associated with positive change in beliefs about risks of epilepsy ( relative risk [ RR ] 2.00 , 95 % CI 1.03-3 .95 ) and having nontraditional religious beliefs ( RR 2.01 , 95 % CI 1.01-3 .99 ) .


Reduced seizure frequency was associated with improved adherence ( RR 1.72 , 95 % CI 1.19-2 .47 ) .


Positive changes in KEBAS were associated with having tertiary education as compared to none ( RR 1.09 , 95 % CI 1.05-1 .14 ) .


Health education improves knowledge about epilepsy , but once only contact does not improve adherence .


However , sustained education may improve adherence in future studies .


Vaccine effectiveness is usually determined in randomized controlled trials ( RCT ) and if effective , additional information , e.g. on cost-effectiveness , is required to allow evidence-based decision making .


A prerequisite for proper health economic modelling is the availability of good quality data on health care resources use , health outcomes and quality-of-life ( QoL ) data .


The `` Collecting health outcomes and economic data on hospitalized Community Acquired Pneumonia ( CHO-CAP ) -- a prospective cohort study '' is executed alongside the Community Acquired Pneumonia Immunization Trial with Adults ( CAPiTA trial ) to capture health outcomes and economic data of elderly hospitalized with CAP and matched controls without CAP .


CAPiTA is a placebo-controlled double-blind RCT evaluating the effectiveness of a 13-valent conjugated pneumococcal vaccine in preventing vaccine-type pneumococcal CAP in 84,496 elderly in the Netherlands .


Participants of CAPiTA , who consented and provided information on health status ( EQ-5D ) and socio-demographic background at the time of vaccination , constitute the source population of CHO-CAP and are eligible for the nested matched cohort study .


CHO-CAP patients hospitalized with CAP form the `` diseased '' cohort and the `` non-diseased '' cohort consists of unaffected persons ( i.e. no CAP ) .


Observations in the diseased cohort and in matched controls from the non-diseased cohort are used to determine excess costs and QoL changes attributable to CAP.Based on an estimated 2,000 CAPiTA participants being hospitalized with CAP and an assumed CHO-CAP participation rate of 30 % of all CAPiTA participants ( 25,000 ) , 600 CAP episodes are expected among CHO-CAP participants ( the `` diseased '' cohort ) .


For each patient with CAP , two non-diseased CHO-CAP subjects will be selected from the CHO-CAP cohort , with matching for age , gender and EQ-5D baseline-score .


Data on healthcare and non-healthcare resources use , quality-of-life ( using EQ-5D and SF-36 questionnaires ) and selected health outcomes will be collected at 0 , 1 , 6 and 12 months after hospitalization for CAP.The CHO-CAP study was approved by the Central Committee on Research involving Human Subjects in the Netherlands .


With an expected 600 CAP episodes this study will be one of the biggest prospectively studied cohorts of hospitalized elderly with CAP with regard to resources use and Qol data .


Strengths of this study further include collection of out-of-pocket costs of patients and productivity losses of both patients and their caregivers and the follow-up period of up to one year post-discharge .


This study is therefore expected to add more in-depth knowledge on the short and longer term outcomes of pneumonia in elderly .


ClinicalTrials.gov , NCT00812084 .


The role of vascular closure devices ( VCD ) for the achievement of hemostasis in patients undergoing transfemoral coronary angiography remains controversial .


To compare outcomes with the use of 2 hemostasis strategies after diagnostic coronary angiography performed via transfemoral access-a VCD-based strategy with 2 types of devices , an intravascular device and an extravascular device , vs standard manual compression .


The primary hypothesis to be tested was that femoral hemostasis achieved through VCD is noninferior to manual compression in terms of vascular access-site complications .


A secondary objective was the comparison of the 2 types of VCD .


Randomized , large-scale , multicenter , open-label clinical trial .


We enrolled 4524 patients undergoing coronary angiography with a 6 French sheath via the common femoral artery from April 2011 through May 2014 in 4 centers in Germany .


Last 30-day follow-up was performed in July 2014 .


After angiography of the access site , patients were randomized to hemostasis with an intravascular VCD , extravascular VCD , or manual compression in a 1:1:1 ratio .


Primary end point : the composite of access site-related vascular complications at 30 days after randomization with a 2 % noninferiority margin .


Secondary end points : time to hemostasis , repeat manual compression , and VCD failure .


An - level of .025 was chosen for primary and secondary comparisons .


Of the 4524 enrolled patients , 3015 were randomly assigned to a VCD group ( 1509 received intravascular VCD and 1506 received extravascular VCD ) and 1509 patients were randomly assigned to the manual compression group .


Before hospital discharge , duplex sonography of the access site was performed in 4231 ( 94 % ) patients .


The primary end point was observed in 208 patients ( 6.9 % ) assigned to receive a VCD and 119 patients ( 7.9 % ) assigned to manual compression ( difference , -1.0 % [ 1-sided 97.5 % CI , 0.7 % ] ; P for noninferiority < .001 ) .


Time to hemostasis was significantly shorter in patients with VCD ( 1 minute [ interquartile range { IQR } , 0.5-2 .0 ] ) , vs manual compression ( 10 minutes [ IQR , 10-15 ] ; P < .001 ) .


Time to hemostasis was significantly shorter among patients with intravascular VCD ( 0.5 minute [ IQR , 0.2-1 .0 ] ) , vs extravascular VCD ( 2.0 minutes [ IQR , 1.0-2 .0 ] ; P < .001 ) and closure device failure was also significantly lower among those with intravascular vs extravascular VCD ( 80 patients [ 5.3 % ] , vs 184 patients [ 12.2 % ] ; P < .001 ) .


In patients undergoing transfemoral coronary angiography , VCDs were noninferior to manual compression in terms of vascular access-site complications and reduced time to hemostasis .


clinicaltrials.gov Identifier : NCT01389375 .


Maximizing ART efficiency is of growing interest .


This study assessed the efficacy , safety , pharmacokinetics and economics of a darunavir dose-reduction strategy .


This was a multicentre , randomized , open-label clinical trial in HIV-infected patients with plasma HIV-1 RNA < 50 copies/mL while receiving triple ART including 800 mg of darunavir once daily .


Participants were randomized to continue 800 mg of darunavir ( DRV800 ) or to 600 mg of darunavir ( DRV600 ) , both once daily .


Treatment failure was defined as two consecutive HIV-1 RNA determinations > 50 copies/mL or discontinuation of study treatment by week 48 .


The study was registered at https://www.clinicaltrialsregister.eu ( trial number 2011-006272-39 ) .


Fifty participants were allocated to each arm .


The mean ( SD ) CD4 + T cell count at baseline was 562 ( 303 ) cells/mm ( 3 ) and HIV-1 RNA had been < 50 copies/mL for a median ( IQR ) of 106.9 ( 43.4-227 .9 ) weeks before enrolment .


At week 48 no treatment failure had occurred in 45/50 ( 90 % ) DRV600 patients and in 47/50 ( 94 % ) DRV800 patients ( difference -4 % ; 95 % CI lower limit , -12.9 % ) .


When only patients with virological data were considered , that endpoint was met by 45/48 ( 94 % ) in the DRV600 arm and 47/49 ( 96 % ) in the DRV800 arm ( difference -2.2 % ; 95 % CI lower limit , -9.6 % ) .


Darunavir exposure was similar in the two arms .


The average reduction in annual cost per successfully treated DRV600-arm patient was US$ 7273 .


The efficacy of a darunavir daily dose of 600 mg seemed to be similar to the efficacy of the standard 800 mg dose in virologically suppressed HIV-infected patients on triple ART .


This strategy can potentially translate to substantial savings in the cost of care of HIV-infected patients .


The postpartum period can be a challenging time particularly for first-time mothers .


This study aimed to assess two different interventions designed to reduce stress in the postpartum among first-time mothers .


Healthy first-time mothers with healthy newborns were recruited from hospitals in Beirut , Lebanon after delivery .


The two interventions were a 20-minute film addressing common stressors in the postpartum period and a 24-hour telephone support hotline .


Participants were randomized to one of four study arms to receive either the postpartum support film , the hotline service , both interventions , or a music CD ( control ) .


Participants were interviewed at eight to twelve weeks postpartum for assessment of levels of stress as measured by the Cohen Perceived Stress Scale ( PSS-10 ) .


Of the 632 eligible women , 552 ( 88 % ) agreed to participate in the study .


Of those , 452 ( 82 % ) completed the study .


Mean PSS-10 scores of mothers who received the film alone ( 15.76 ) or the film with the hotline service ( 15.86 ) were significantly lower than that of the control group ( 18.93 ) ( p-value < 0.01 ) .


Among mothers who received the hotline service alone mean PSS-10 score ( 16.98 ) was also significantly lower than that of the control group ( p-value < 0.05 ) .


Both our postpartum support film and the 24-hour telephone hotline service reduced stress in the postpartum period in first-time mothers .


These simple interventions can be easily implemented and could have an important impact on the mental wellbeing of new mothers .


The trial was registered with clinicaltrials.gov ( identifier # NCT00857051 ) on March 5 , 2009 .


To examine whether dexmedetomidine reduces the injection pain of propofol and rocuronium and to investigate whether the decrease in injection pain is associated with the known sedative action of dexmedetomidine .


Randomized , double-blind , placebo-controlled clinical comparison study .


Patients undergoing general anesthesia with intubation received 40 mg of 1 % lidocaine ( lidocaine group ; n = 28 ) , 0.25 g/kg of dexmedetomidine ( low-dose group ; n = 27 ) , 0.5 g/kg of dexmedetomidine ( subclinical dose group ; n = 28 ) , 1.0 g/kg of dexmedetomidine ( clinical dose group , n = 27 ) , or normal saline ( saline group ; n = 28 ) before anesthetic induction .


Pain associated with propofol and rocuronium injection was assessed using a 10-point verbal analog scale ( VAS ) and a 4-point withdrawal movement scale , respectively .


The BIS value was measured 60 seconds after administration of the study drug , and at the time of rocuronium injection and intubation .


The overall incidence of withdrawal movements due to rocuronium decreased significantly as the dose of dexmedetomidine increased ( 92.8 % , 85.2 % , 78.6 % , and 51.9 % in the saline , low-dose , subclinical dose , and clinical dose groups , respectively ; P = 0.001 ) .


There was no significant difference in BIS values among the groups 60 seconds after study drug administration or at the time of rocuronium injection .


Dexmedetomidine reduced pain associated with rocuronium injection in a dose-dependent manner .


This effect was not associated with the decrease in BIS value .


Eosinophilic esophagitis ( EoE ) is a chronic antigen-driven allergic inflammatory disease , likely involving the interplay of genetic and environmental factors , yet their respective contributions to heritability are unknown .


To quantify the risk associated with genes and environment on familial clustering of EoE .


Family history was obtained from a hospital-based cohort of 914 EoE probands ( n = 2192 first-degree `` Nuclear-Family '' relatives ) and an international registry of monozygotic and dizygotic twins/triplets ( n = 63 EoE `` Twins '' probands ) .


Frequencies , recurrence risk ratios ( RRRs ) , heritability , and twin concordance were estimated .


Environmental exposures were preliminarily examined .


Analysis of the Nuclear-Family-based cohort revealed that the rate of EoE , in first-degree relatives of a proband , was 1.8 % ( unadjusted ) and 2.3 % ( sex-adjusted ) .


RRRs ranged from 10 to 64 , depending on the family relationship , and were higher in brothers ( 64.0 ; P = .04 ) , fathers ( 42.9 ; P = .004 ) , and males ( 50.7 ; P < .001 ) than in sisters , mothers , and females , respectively .


The risk of EoE for other siblings was 2.4 % .


In the Nuclear-Family cohort , combined gene and common environment heritability was 72.0 % 2.7 % ( P < .001 ) .


In the Twins cohort , genetic heritability was 14.5 % 4.0 % ( P < .001 ) , and common family environment contributed 81.0 % 4 % ( P < .001 ) to phenotypic variance .


Probandwise concordance in monozygotic co-twins was 57.9 % 9.5 % compared with 36.4 % 9.3 % in dizygotic co-twins ( P = .11 ) .


Greater birth weight difference between twins ( P = .01 ) , breast-feeding ( P = .15 ) , and fall birth season ( P = .02 ) were associated with twin discordance in disease status .


EoE RRRs are increased 10 - to 64-fold compared with the general population .


EoE in relatives is 1.8 % to 2.4 % , depending on relationship and sex .


Nuclear-Family heritability appeared to be high ( 72.0 % ) .


However , the Twins cohort analysis revealed a powerful role for common environment ( 81.0 % ) compared with additive genetic heritability ( 14.5 % ) .


Serious case reviews and research studies have indicated weaknesses in risk assessments conducted by child protection social workers .


Social workers are adept at gathering information but struggle with analysis and assessment of risk .


The Department for Education wants to know if the use of a structured decision-making tool can improve child protection assessments of risk .


This multi-site , cluster-randomised trial will assess the effectiveness of the Safeguarding Children Assessment and Analysis Framework ( SAAF ) .


This structured decision-making tool aims to improve social workers ' assessments of harm , of future risk and parents ' capacity to change .


The comparison is management as usual .


Children 's Services Departments ( CSDs ) in England willing to make relevant teams available to be randomised , and willing to meet the trial 's training and data collection requirements .


CSDs where there were concerns about performance ; where a major organisational restructuring was planned or under way ; or where other risk assessment tools were in use.Six CSDs are participating in this study .


Social workers in the experimental arm will receive 2 days training in SAAF together with a range of support materials , and access to limited telephone consultation post-training .


The primary outcome is child maltreatment .


This will be assessed using data collected nationally on two key performance indicators : the first is the number of children in a year who have been subject to a second Child Protection Plan ( CPP ) ; the second is the number of re-referrals of children because of related concerns about maltreatment .


Secondary outcomes are : i ) the quality of assessments judged against a schedule of quality criteria and ii ) the relationship between the three assessments required by the structured decision-making tool ( level of harm , risk of ( re ) abuse and prospects for successful intervention ) .


This is the first study to examine the effectiveness of SAAF .


It will contribute to a very limited literature on the contribution that structured decision-making tools can make to improving risk assessment and case planning in child protection and on what is involved in their effective implementation .


ISRCTN 45137562 15 July 2014 .


This study evaluated the effectiveness of a stress management intervention combining individual cognitive behavioral therapy ( CBT ) with a brief workplace intervention on self-reported measures of sleep and cognitive functioning among patients on sick leave due to work-related stress complaints .


Participants were patients referred to the regional Department of Occupational Medicine .


Inclusion criteria were ( i ) sick leave due to work-related stress complaints and ( ii ) a diagnosis of adjustment disorder/reactions to stress or mild depression .


Participants ( N = 137 ) were randomized to either an intervention ( N = 57 ) or control ( N = 80 ) group .


The intervention comprised six sessions with a psychologist and the offer of a small workplace intervention .


Questionnaires were answered at baseline and after 4 , and 10 months .


Symptoms were significantly reduced over time in both groups but there was no significant treatment effect on sleep or cognitive outcomes at any time point .


From 0-4 months , there was a tendency for larger improvements in the intervention group with regards to sleep and cognitive failures in distraction .


Although neither was significant , the results came close to significance depicting a small effect size ( Cohen 's d ) on sleep complaints and distractions ( but not memory ) .


The specific intervention was not superior to the control condition in reducing symptoms of sleep problems and cognitive difficulties at any time point during the 10-month follow-up period .


Substantial improvements in symptoms over time were seen in both groups .


To determine the efficacy of tranilast as an adjunctive therapy in conjunctival autograft .


Twenty-nine patients were randomly allocated to the Tranilast Group ( n = 15 ) or the Control Group ( n = 14 ) .


The Tranilast Group received a subconjunctival injection of 0.5 % tranilast 30 days prior to surgery .


Conjunctival autograft was performed in both groups using fibrin sealant and 0.02 % subconjunctival mitomycin C at the end of the surgery .


After the resection of the pterygium , immunohistochemistry was performed with 100 cells to identify epithelial cells positive for transforming growth factor - ( TGF - ) .


Subjective symptoms were evaluated using a 5-point scale , and the recurrence rate was assessed .


Both groups showed improvements in their symptoms and similar clinical results .


Compared with the Control Group , the Tranilast Group failed to show a decreased recurrence rate ( p = 0.59 ) .


However , the number of epithelial cells expressing TGF - was lower in the Tranilast Group ( 5 cells ; 95 % CI : 2.56-13 .15 ; Control Group , 16 cells , 95 % CI : 11.53-24 .76 ; p = 0.01 ) .


Minimal but reversible complications , including glaucoma secondary to corticosteroids and granuloma , occurred during the study .


Tranilast was effective in decreasing the number of pterygium epithelial cells expressing TGF - .


Violence and injury risk behaviors , alcohol and drug use problems , and posttraumatic stress disorder ( PTSD ) and depressive symptoms occur frequently among adolescents presenting to acute care medical settings after traumatic physical injury .


To test the effectiveness of a stepped collaborative care intervention targeting this constellation of risk behaviors and symptoms in randomly sampled hospitalized adolescents with and without traumatic brain injury .


A pragmatic randomized clinical trial was conducted at a single US level I trauma center .


Participants included 120 adolescents aged 12 to 18 years randomized to intervention ( n = 59 ) and control ( n = 61 ) conditions .


Stepped collaborative care intervention included motivational interviewing elements targeting risk behaviors and substance use as well as medication and cognitive behavioral therapy elements targeting PTSD and depressive symptoms .


Adolescents were assessed at baseline before randomization and 2 , 5 , and 12 months after injury hospitalization .


Standardized instruments were used to assess violence risk behaviors , alcohol and drug use , and PTSD and depressive symptoms .


The investigation attained more than 95 % adolescent follow-up at each assessment point .


At baseline , approximately one-third of the participants endorsed the violence risk behavior of carrying a weapon .


Regression analyses demonstrated that intervention patients experienced significant reductions in weapon carrying compared with controls during the year after injury ( grouptime effect , F3 ,344 = 3.0 ; P = .03 ) .


At 12 months after the injury , 4 ( 7.3 % ) intervention patients vs 13 ( 21.3 % ) control patients reported currently carrying a weapon ( relative risk ,0.31 ; 95 % CI , 0.11-0 .90 ) .


The intervention was equally effective in reducing the risk of weapon carrying among injured adolescents with and without traumatic brain injury .


Other treatment targets , including alcohol and drug use problems and high levels of PTSD and depressive symptoms , occurred less frequently in the cohort relative to weapon carrying and were not significantly affected by the intervention .


Collaborative care intervention reduced the risk of adolescent weapon carrying during the year after the injury hospitalization .


Future investigation should replicate this preliminary observation .


If the finding is replicated , orchestrated investigative and policy efforts could systematically implement and evaluate screening and intervention procedures targeting youth violence prevention at US trauma centers .


clinicaltrials.gov identifier : NCT00619255 .


Formula-fed ( FF ) infants often have harder stools and higher stool concentrations of fatty acid soaps compared to breastfed infants .


Feeding high sn-2 palmitate or the prebiotic oligofructose ( OF ) may soften stools , reduce stool soaps , and decrease fecal calcium loss .


We investigated the effect of high sn-2 palmitate alone and in combination with OF on stool palmitate soap , total soap and calcium concentrations , stool consistency , gastrointestinal ( GI ) tolerance , anthropometrics , and hydration in FF infants .


This double-blind trial randomized 165 healthy term infants 25-45 days old to receive Control formula ( n = 54 ) , formula containing high sn-2 palmitate ( sn-2 ; n = 56 ) , or formula containing high sn-2 palmitate plus 3 g/L OF ( sn-2 + OF ; n = 55 ) .


A non-randomized human milk ( HM ) - fed group was also included ( n = 55 ) .


The primary endpoint , stool composition , was determined after 28 days of feeding , and was assessed using ANOVA accompanied by pairwise comparisons .


Stool consistency , GI tolerance and hydration were assessed at baseline , day 14 ( GI tolerance only ) and day 28 .


Infants fed sn-2 had lower stool palmitate soaps compared to Control ( P = 0.0028 ) ; while those fed sn-2 + OF had reduced stool palmitate soaps compared to both Control and sn-2 ( both P < 0.0001 ) .


Stool total soaps and calcium were lower in the sn-2 + OF group than either Control ( P < 0.0001 ) or sn-2 ( P < 0.0001 ) .


The HM-fed group had lower stool palmitate soaps , total soaps and calcium ( P < 0.0001 for each comparison ) than all FF groups .


The stool consistency score of the sn-2 + OF group was lower than Control and sn-2 ( P < 0.0001 ) , but higher than the HM-fed group ( P < 0.0001 ) .


GI tolerance was similar and anthropometric z-scores were < 0.2 SD from the WHO growth standards in all groups , while urinary hydration markers were within normal range for all FF infants .


Increasing sn-2 palmitate in infant formula reduces stool palmitate soaps .


A combination of high sn-2 palmitate and OF reduces stool palmitate soaps , total soaps and calcium , while promoting softer stools .


This study was registered on http://www.clinicaltrials.gov: number NCT02031003 .


A number of studies have evaluated the effects of subcutaneous drainage during digestive surgery .


All of the previous studies assessed the usefulness of active-suctioning drain , including two randomized controlled studies which found no benefit for the placement of active-suctioning drains in digestive surgery .


The utility of passive drainage has not been evaluated previously .


The purpose of this study was to evaluate the efficacy of subcutaneous passive drainage system for preventing surgical site infections during major colorectal surgery .


A total of 263 patients who underwent major colorectal surgery were enrolled in this study .


Patients were randomly assigned to receive subcutaneous passive drainage or no drainage .


The primary outcome measured was the incidence of superficial surgical site infections .


The secondary outcomes measured were the development of hematomas , seromas , and wound dehiscence .


Finally , a total of 246 patients ( 124 underwent passive drainage , and 122 underwent no drainage ) were included in the analysis after randomization .


There was a significant difference in the incidence of superficial surgical site infections between patients assigned to the passive drainage and no drainage groups ( 3.2 % vs 9.8 % , respectively , P = 0.041 ) .


There were no cases that developed a hematoma , seroma , or wound dehiscence in either group .


A subgroup analysis revealed that male gender , age 75 years , diabetes mellitus , American Society of Anesthesiologists ( ASA ) status 2 , blood loss 100 ml , and open access were factors that were associated with a beneficial effect of subcutaneous passive drainage .


Subcutaneous passive drainage provides benefits over no drainage in patients undergoing major colorectal surgery .


The aim of this study was to elucidate the physiological adjustment effect of forest therapy based on the Law of Initial Value .


The experiments were conducted in nine forest and urban areas in Japan during the period from 2011 to 2012 .


There were 12 male Japanese university students participating in each of the nine experiments ( total , 108 participants ) .


Of these , 98 subjects ( mean age standard deviation , 21.4 1.6 years ) were analyzed .


The subjects were instructed to view a real forest landscape or urban area for 15 min .


The systolic blood pressure , diastolic blood pressure , and pulse rate of each subject were measured .


We analyzed the correlation between the initial values ( after city viewing ) and the differences in values between the two environments ( after forest viewing-after city viewing ) .


There was a negative correlation between the initial values and the differences in values between the two environments .


The subjects whose initial systolic blood pressure , diastolic blood pressure , and pulse rate were high showed marked decreases in these parameters as their response after viewing the forest environment , whereas those whose initial systolic blood pressure , diastolic blood pressure , and pulse rate were low showed increases in these parameters as their response .


These results support the premise that the physiological effect of a forest environment can differ depending on a subject 's initial response values .


Moreover , it was clear that forest therapy caused physiological adjustment , normalizing blood pressure and pulse rate .


The most important action in the resuscitation of a newborn in the delivery room is to establish effective assisted ventilation .


The face mask and endotracheal tube are the devices used to achieve this goal .


Laryngeal mask airways that fit over the laryngeal inlet have been shown to be effective for ventilating newborns at birth and should be considered as an alternative to facemask ventilation or endotracheal intubation among newborns weighing > 2,000 g or delivered 34weeks ' gestation .


A recent systematic review and meta-analysis of supraglottic airways in neonatal resuscitation reported the results of four randomized controlled trials ( RCTs ) stating that fewer infants in the group using laryngeal mask airways required endotracheal intubation ( 1.5 % ) compared to the group using face masks ( 12.0 % ) .


However , there were methodological concerns over all the RCTs including the fact that the majority of the operators in the trials were anesthesiologists.Our hypothesis is based on the assumption that ventilating newborns needing positive pressure ventilation with a laryngeal mask airway will be more effective than ventilating with a face mask in a setting where neonatal resuscitation is performed by midwives , nurses , and pediatricians .


The primary aim of this study will be to assess the effectiveness of the laryngeal mask airway over the face mask in preventing the need for endotracheal intubation .


This will be an open , prospective , randomized , single center , clinical trial .


In this study , 142 newborns weighing > 1,500 g or delivered 34weeks gestation needing positive pressure ventilation at birth will be randomized to be ventilated with a laryngeal mask airway ( LMA SupremeTM , LMA Company , UK - intervention group ) or with a face mask ( control group ) .


Proportion of newborns needing endotracheal intubation .


Apgar score at 5minutes , time to first breath , onset of the first cry , duration of resuscitation , death or moderate to severe hypoxic-ischemic encephalopathy within 7days of life .


ClinicalTrials.gov identifier : NCT01963936 ( October 11 , 2013 ) .


Hypertonic citrate adenine ( HC-A ) solution , containing citrate and adenine , has become the most widely used preservation solution in isolated kidney preservation in China .


More than 30 years of clinical application has demonstrated that HC-A is safe and effective .


With higher requirement for kidney preservation and less tolerance of preservation-related graft dysfunction , a new solution , HC-A II , for kidney preservation was developed by Shanghai Changzheng Hospital .


Upon approval from the State Food and Drug Administration of China ( SFDA ) , a multi-center randomized controlled trial was performed to study the efficacy and safety of HC-A II in kidney preservation from 2008 to 2012 , using histidine-tryptophan-ketoglutarate solution ( HTK ) as control ( HC-A , n = 137 , and HTK , n = 140 ) .


There were no differences with regard to donor and recipient demographics or cold ischemia .


The trial results showed no significant difference in DGF rate , or patient or graft survival between the 2 groups .


No significant difference between the 2 groups was found in the percentage of patients whose serum creatinine ( SCr ) test results returned to normal within 28 days ( P > 0.05 ) , nor were there a significant difference in safety evaluation ( P > 0.05 ) .


HC-A II and HTK appear to have similar efficacy in isolated kidney preservation .


Prevention research has to elucidate how families with overweight children can be convinced to participate in obesity intervention trials .


Here we describe the detailed recruitment process for a telephone-based obesity prevention programme for families with overweight children and present participation rates , the study design and a socio-demographic description of participating families .


Overweight ( BMI > 90th percentile ) children and adolescents 4-17 years of age were screened via the German paediatrician network CrescNet .


The prevention programme ( multiple computer aided telephone counselling interviews ) was suggested to eligible families via local paediatricians .


Participating families were compared anthropometrically and socio-demographically to the entire screening population and to micro-census data , a representative national survey .


The screening process assessed 4005 candidates for eligibility .


Paediatricians reported having suggested programme participation to 3387 candidates ( referred to as 100 % ) .


427 candidates ( 12.6 % ) returned a written consent for programme participation .


303 candidates ( 9.0 % ) started the intervention .


The study population ( n = 303 ) included more obese ( 45.6 % vs. 33.2 % ; p < 0.001 ) and fewer overweight participants ( 40.4 % vs. 55.2 % ; p < 0.001 ) than the entire screening population .


Compared to the micro-census , families with adolescents ( 8.2 % vs. 16.9 % ; p < 0.001 ) and single parents ( 16.0 % vs. 23.3 % ; p < 0.005 ) were underrepresented in the study population , whereas families living in rural areas were overrepresented ( 58.7 % vs. 50.2 % ; p < 0.005 ) .


Although 84.6 % of the paediatricians forwarded the suggestion for programme participation to eligible families , participation rates for this low-threshold ; telephone-based obesity intervention remained very low .


`` Hard-to-engage groups '' for effective obesity prevention seem to include single parents , as well as parents of adolescents .


To examine the cardiopulmonary effects of infusions of remifentanil or morphine , and their influence on recovery of horses anesthetized with isoflurane and dexmedetomidine .


Randomized crossover study with 7-day rest periods .


Six adult horses ( 507 61 kg ) .


After the horses were sedated with xylazine , anaesthesia was induced with ketamine and diazepam , and maintained with isoflurane .


After approximately 60 minutes , a dexmedetomidine infusion was started ( 0.25 g kg ( -1 ) then 1.0 g ( -1 ) kg ( -1 ) hour ( -1 ) ) in combination with either saline ( group S ) , morphine ( 0.15 mg kg ( -1 ) then 0.1 mg kg ( -1 ) hour ( -1 ) ; group M ) , or remifentanil ( 6.0 g kg ( -1 ) hour ( -1 ) ; group R ) for 60 minutes .


Mean arterial pressure , heart rate , end-tidal carbon dioxide tension , and end-tidal isoflurane concentration were recorded every 5 minutes .


Core body temperature , cardiac output , right ventricular and arterial blood-gas values were measured every 15 minutes .


Cardiac index , systemic vascular resistance ( SVR ) , intrapulmonary shunt fraction , alveolar dead space , oxygen delivery and extraction ratio were calculated .


Recoveries were videotaped and scored by two observers blinded to the treatment .


Data were analyzed using repeated measures anova followed by Dunnett 's or Bonferroni 's significant difference test .


Recovery scores were analyzed using a Kruskal-Wallis test .


No significant differences were found among groups .


Compared to baseline , heart rate decreased and SVR increased significantly in all groups , and cardiac index significantly decreased in groups S and M. Hemoglobin concentration , oxygen content and oxygen delivery significantly decreased in all groups .


The oxygen extraction ratio significantly increased in groups M and R. Lactate concentration significantly increased in group S. Recovery scores were similar among groups .


Dexmedetomidine alone or in combination with remifentanil or morphine infusions was infused for 60 minutes without adverse effects in the 6 healthy isoflurane-anesthetized horses in this study .


It is well established through randomized trials that oral antibiotics given with or without a mechanical bowel preparation ( MBP ) prior to colorectal procedures reduce complications , while MBP given alone provides no benefit .


We aimed to characterize trends surrounding bowel preparation in children and determine whether contemporary practice is evidence-based .


Retrospective analysis of patients undergoing colorectal procedures at 42 children 's hospitals ( 1/2/2007 -12 / 31/2011 ) was performed .


Patients were analyzed for diagnosis , pre-admission status , and inpatient bowel preparation .


Bowel preparation was considered evidence-based if oral antibiotics were utilized with or without a MBP .


49 % of all patients were pre-admitted ( n = 5,473 ) , and the most common diagnoses were anorectal malformations ( 55 % ) , inflammatory bowel disease ( 26 % ) , and Hirschsprung 's Disease ( 19 % ) .


The most common preparation approaches were MBP alone ( 54.3 % ) , MBP + oral antibiotics ( 18.8 % ) , and oral antibiotics alone ( 4.2 % ) , although significant variation was found in hospital-specific rates for each approach ( MBP alone : 0-96 .1 % , MBP + oral antibiotics : 0-83 .6 % , orals alone : 0-91 .6 % , p < 0.0001 ) .


Only 22.9 % of all patients received an evidence-based preparation ( range by hospital : 0-92 .3 % , p < 0.0001 ) , and this rate decreased significantly during the five-year study period ( 27.6 % in 2007 vs. 17.3 % in 2011 , p < 0.0001 ) .


According to the best available clinical evidence , less than a quarter of all children pre-admitted for elective colorectal procedures receive a bowel preparation proven to reduce infectious complications .


To assess the effects of short-term resistance training and pulsed electromagnetic fields on bone metabolism and joint function in patients with haemophilia with osteoporosis .


A randomized , controlled , patient and blood sample assessor-blinded , six-week trial , three times weekly .


Hospital outpatients with severe haemophilia A and osteoporosis .


Forty-eight patients were randomly assigned to resistance training ( RT , n = 13 ) , combined resistance training with pulsed electromagnetic fields ( RTPEMF , n = 12 ) , pulsed electromagnetic fields ( PEMF , n = 11 ) and control ( n = 12 ) groups .


The RT group received 30-40 minutes of resistance exercises and placebo pulsed electromagnetic fields .


The RTPEMF group received the same exercises with lower repetition and 30 minutes of pulsed electromagnetic fields .


The PEMF group was exposed to 60 minutes of pulsed electromagnetic fields ( 30 Hz and 40 Gauss ) .


Bone-specific alkaline phosphatase , N-terminal telopeptide of type 1 collagen , and joint function , using the modified Colorado Questionnaire , were measured before and after the programme .


The absolute change of bone-specific alkaline phosphatase was significant in the RT and RTPEMF groups compared with the control group ( 25.41 14.40 , 15.09 5.51 , and -4.73 2.93 U/L , respectively ) .


The absolute changes in the total score for joint function were significant for knees , ankles , and elbows in the RT group ( 9.2 1.38 , 5.1 0.5 , and 3.2 0.8 , respectively ) and the RTPEMF group ( 7.7 1.0 , 3.3 0.6 , and 2.5 0.7 , respectively ) compared to the PEMF and control groups .


This value was significant for knee joints in the PEMF group compared to the control group ( 3.4 0.5 and 0.66 0.4 , respectively ) .


Resistance training is effective for improving bone formation and joint function in severe haemophilia A patients with osteoporosis .


This study compares the long-term results of pneumatic dilatations versus laparoscopic myotomy using treatment failure as the primary outcome .


The frequency and degree of dysphagia , the effects on quality of life ( QoL ) , and health economy were also examined .


Fifty-three patients with achalasia were randomized to laparoscopic myotomy with a posterior partial fundoplication [ laparoscopic myotomy ( LM ) n = 25 ] or repetitive pneumatic dilatation [ pneumatic dilatation ( PD ) n = 28 ] .


The median observation period was 81.5 months ( range 12-131 ) .


At the minimal follow-up of 5 years , ten patients ( 36 % ) in the dilatation group and two patients ( 8 % ) in the myotomy group , including two patients lost to follow-up ( one in each arm ) , were classified as failures ( p = 0.016 ) .


The cumulative incidence of treatment failures was analyzed by survival statistics .


Taking the entire follow-up period into account , a significant difference was observed in favor of the LM strategy ( p = 0.02 ) .


Although both treatments resulted in significant improvements in dysphagia scores , LM was significantly favored over PD after 1 and 3 years , but not after 5 years .


Health-related QoL assessed by the personal general well being score was higher in the LM group after 3 years , but the difference was not fully statistically significant at 5 years .


Direct medical costs during the entire follow-up period were in median $ 13,421 for LM as compared to $ 5,558 for PD ( p = 0.001 ) .


This long-term follow-up of a randomized clinical study shows that LM is superior to repetitive PD treatment of newly diagnosed achalasia , albeit that this surgical strategy is burdened by high initial direct medical costs .


www.ClinicalTrials.gov NCT 02086669 .


Individual barriers to weight loss and physical activity goals in the Diabetes Prevention Program , a randomized trial with 3.2 years average treatment duration , have not been previously reported .


Evaluating barriers and the lifestyle coaching approaches used to improve adherence in a large , diverse participant cohort can inform dissemination efforts .


Lifestyle coaches documented barriers and approaches after each session ( mean session attendance = 50.321.8 ) .


Subjects were 1076 intensive lifestyle participants ( mean age = 50.6 years ; mean BMI = 33.9 kg/m ; 68 % female , 48 % non-Caucasian ) .


Barriers and approaches used to improve adherence were ranked by the percentage of the cohort for whom they applied .


Barrier groupings were also analyzed in relation to baseline demographic characteristics .


Top weight loss barriers reported were problems with self-monitoring ( 58 % ) ; social cues ( 58 % ) ; holidays ( 54 % ) ; low activity ( 48 % ) ; and internal cues ( thought/mood ) ( 44 % ) .


Top activity barriers were holidays ( 51 % ) ; time management ( 50 % ) ; internal cues ( 30 % ) ; illness ( 29 % ) , and motivation ( 26 % ) .


The percentage of the cohort having any type of barrier increased over the long-term intervention period .


A majority of the weight loss barriers were significantly associated with younger age , greater obesity , and non-Caucasian race/ethnicity ( p-values vary ) .


Physical activity barriers , particularly thought and mood cues , social cues and time management , physical injury or illness and access/weather , were most significantly associated with being female and obese ( p < 0.001 for all ) .


Lifestyle coaches used problem-solving with most participants ( 75 % short-term ; > 90 % long term ) and regularly reviewed self-monitoring skills .


More costly approaches were used infrequently during the first 16 sessions ( 10 % ) but increased over 3.2 years .


Behavioral problem solving approaches have short and long term dissemination potential for many kinds of participant barriers .


Given minimal resources , increased attention to training lifestyle coaches in the consistent use of these approaches appears warranted .


Lack of universal , annual testing for human immunodeficiency virus ( HIV ) in health facilities suggests that expansion of HIV testing and counselling ( HTC ) to non-clinical settings is critical to the achievement of national goals for prevention , care and treatment .


Consideration should be given to the ability of lay counsellors to perform home-based HTC in community settings .


We implemented a community cluster randomized controlled trial of home-based HTC in Sisonke District , South Africa .


Trained lay counsellors conducted door-to-door HIV testing using the same rapid tests used by the local health department at the time of the study ( SD Bioline and Sensa ) .


To monitor testing quality and counsellor skill , additional dry blood spots were taken and sent for laboratory-based enzyme-linked immunosorbent assay ( ELISA ) testing .


Sensitivity and specificity were calculated using the laboratory result as the gold standard .


From 3986 samples , the counsellor and laboratory results matched in all but 23 cases .


In 18 cases , the counsellor judged the result as indeterminate , whereas the laboratory judged 10 positive , eight negative and three indeterminate , indicating that the counsellor may have erred on the side of caution .


Sensitivity was 98.0 % ( 95 % CI : 96.3-98 .9 % ) , and specificity 99.6 % ( 95 % CI : 99.4-99 .7 % ) , for the lay counsellor field-based rapid tests .


Both measures are high , and the lower confidence bound for specificity meets the international standard for assessing HIV rapid tests .


These findings indicate that adequately trained lay counsellors are capable of safely conducting high-quality rapid HIV tests and interpreting the results as per the kit guidelines .


These findings are important given the likely expansion of community and home-based testing models and the shortage of clinically trained professional staff .


Comparison of a multimodal intervention WE CALL ( study initiated phone support/information provision ) versus a passive intervention YOU CALL ( participant can contact a resource person ) in individuals with first mild stroke .


This study is a single-blinded randomized clinical trial .


Primary outcome includes unplanned use of health services ( participant diaries ) for adverse events and quality of life ( Euroquol-5D , Quality of Life Index ) .


Secondary outcomes include planned use of health services ( diaries ) , mood ( Beck Depression Inventory II ) , and participation ( Assessment of Life Habits [ LIFE-H ] ) .


Blind assessments were done at baseline , 6 , and 12 months .


A mixed model approach for statistical analysis on an intention-to-treat basis was used where the group factor was intervention type and occasion factor time , with a significance level of 0.01 .


We enrolled 186 patients ( WE = 92 ; YOU = 94 ) with a mean age of 62.5 12.5 years , and 42.5 % were women .


No significant differences were seen between groups at 6 months for any outcomes with both groups improving from baseline on all measures ( effect sizes ranged from 0.25 to 0.7 ) .


The only significant change for both groups from 6 months to 1 year ( n = 139 ) was in the social domains of the LIFE-H ( increment in score , 0.4 / 9 1.3 [ 95 % confidence interval , 0.1-0 .7 ] ; effect size , 0.3 ) .


Qualitatively , the WE CALL intervention was perceived as reassuring , increased insight , and problem solving while decreasing anxiety .


Only 6 of 94 ( 6.4 % ) YOU CALL participants availed themselves of the intervention .


Although the 2 groups improved equally over time , WE CALL intervention was perceived as helpful , whereas YOU CALL intervention was not used .


URL : http://www.controlled-trials.com .


Unique identifier : ISRCTN95662526 .


The consumption of citrus fruits is associated with health benefits .


However , clinical data regarding the effects of grapefruit flavanone consumption on vascular function are lacking .


The objective of the present study was to address the role of flavanones in the long-term effects induced by grapefruit juice ( GFJ ) consumption on vascular function in healthy postmenopausal women .


Forty-eight healthy postmenopausal women aged 50-65 y within 3-10 y since menopause , a body mass index ( in kg/m ( 2 ) ) of 19-30 , and a waist size > 88 cm completed this double-blind , randomized , controlled , crossover trial .


These volunteers were randomly assigned to consume 340 mL GFJ/d , providing 210 mg naringenin glycosides , or a matched control drink without flavanones for 6 mo each , with a 2-mo washout between beverages .


The primary endpoint was the assessment of endothelial function in the brachial artery by using flow-mediated dilation .


Blood pressure , arterial stiffness , and endothelial function in the peripheral arterial bed were also evaluated as indicators of vascular function .


These measurements and blood collection for clinical biochemical markers were performed in overnight-fasted subjects before and after the 6-mo treatment periods .


The mean SD carotid-femoral pulse wave velocity , which reflects central aortic stiffness , was statistically significantly lower after consumption of GFJ ( 7.36 1.15 m/s ) than after consumption of the matched control drink without flavanones ( 7.70 1.36 m/s ) , with a P value of 0.019 for the treatment effect .


Endothelial function in macro - and microcirculation , blood pressure , anthropometric measures , glucose metabolism , and biomarkers of inflammation and oxidative stress were not affected by the intervention .


Regular GFJ consumption by middle-aged , healthy postmenopausal women is beneficial for arterial stiffness .


This effect may be related to flavanones present in grapefruit .


This trial was registered at clinicaltrials.gov as NCT01272167 .


Compare public perceptions and intentions to undergo colorectal cancer screening tests following detailed information regarding CT colonography ( CTC ; after non-laxative preparation or full-laxative preparation ) , optical colonoscopy ( OC ) or flexible sigmoidoscopy ( FS ) .


A total of 3,100 invitees approaching screening age ( 45-54 years ) were randomly allocated to receive detailed information on a single test and asked to return a questionnaire .


Outcomes included perceptions of preparation and test tolerability , health benefits , sensitivity and specificity , and intention to undergo the test .


Six hundred three invitees responded with valid questionnaire data .


Non-laxative preparation was rated more positively than enema or full-laxative preparations [ effect size ( r ) = 0.13 to 0.54 ; p < 0.0005 to 0.036 ] ; both forms of CTC and FS were rated more positively than OC in terms of test experience ( r = 0.26 to 0.28 ; all p-values < 0.0005 ) .


Perceptions of health benefits , sensitivity and specificity ( p = 0.250 to 0.901 ) , and intention to undergo the test ( p = 0.213 ) did not differ between tests ( n = 144-155 for each test ) .


Despite non-laxative CTC being rated more favourably , this study did not find evidence that offering it would lead to substantially higher uptake than full-laxative CTC or other methods .


However , this study was limited by a lower than anticipated response rate .


Improving uptake of colorectal cancer screening tests could improve health benefits Potential invitees rate CTC and flexible sigmoidoscopy more positively than colonoscopy Non-laxative bowel preparation is rated better than enema or full-laxative preparations These positive perceptions alone may not be sufficient to improve uptake Health benefits and accuracy are rated similarly for preventative screening tests .


To describe the incidence and outcomes of reoperations for glaucoma in the Tube Versus Trabeculectomy ( TVT ) Study .


Cohort study of patients in a multicenter randomized clinical trial .


The TVT Study enrolled 212 patients with medically uncontrolled glaucoma who had previous cataract and/or glaucoma surgery .


Randomization assigned 107 patients to surgery with a tube shunt ( 350 mm ( 2 ) Baerveldt glaucoma implant ) and 105 patients to trabeculectomy with mitomycin C ( 0.4 mg/mL for 4 minutes ) .


Data were analyzed from patients who failed their assigned treatment and had additional glaucoma surgery .


Outcome measures included intraocular pressure ( IOP ) , use of glaucoma medications , visual acuity , surgical complications , and failure ( IOP > 21 mm Hg or not reduced by 20 % , IOP 5 mm Hg , additional glaucoma surgery , or loss of light perception vision ) .


Additional glaucoma surgery was performed in 8 patients in the tube group and 18 patients in the trabeculectomy group in the TVT Study , and the 5-year cumulative reoperation rate was 9 % in the tube group and 29 % in the trabeculectomy group ( P = .025 ) .


Follow-up ( mean SD ) after additional glaucoma surgery was 28.0 16.0 months in the tube group and 30.5 20.4 months in the trabeculectomy group ( P = .76 ) .


At 2 years after a glaucoma reoperation , IOP ( mean SD ) was 15.0 5.5 mm Hg in the tube group and 14.4 6.6 mm Hg in the trabeculectomy group ( P = .84 ) .


The number of glaucoma medications ( mean SD ) after 2 years of follow-up was 1.1 1.3 in the tube group and 1.4 1.4 in the trabeculectomy group ( P = .71 ) .


The cumulative probability of failure at 1 , 2 , 3 , and 4 years after additional glaucoma surgery was 0 % , 43 % , 43 % , and 43 % , respectively , in the tube group , and 0 % , 9 % , 20 % , and 47 % in the trabeculectomy group ( P = .28 ) .


Reoperations to manage complications were required in 1 patient in the tube group and 5 patients in the trabeculectomy group ( P = .63 ) .


The rate of reoperation for glaucoma was higher following trabeculectomy with mitomycin C than tube shunt surgery in the TVT Study .


Similar surgical outcomes were observed after additional glaucoma surgery , irrespective of initial randomized treatment in the study .


Blockade of platelet activation and aggregation can inhibit metastasis in preclinical models and is associated with cancer prevention .


To test whether disruption of platelet function with clopidogrel and aspirin would decrease the number of circulating tumor cells ( CTCs ) in patients with metastatic breast cancer , a randomized phase II study was performed .


Patients with metastatic breast cancer who were not currently receiving cytotoxic chemotherapy were eligible .


Patients were randomized to receive either clopidogrel and aspirin or to a control group receiving no treatment .


Phlebotomy was performed at baseline , at 2 and 4 weeks , and monthly thereafter to obtain specimens to assess CTC , platelet aggregation , and thrombin activity .


The primary end point was the proportion of patients with detectable CTCs at 1 month .


Forty-eight patients were enrolled and 42 were evaluable at 1month .


Baseline CTC numbers were 5 in 13 % and 1 in 65 % of patients .


Despite adequate platelet function inhibition in the treatment group , the proportion of patients with detectable CTCs was similar between the clopidogrel/aspirin and control groups at baseline ( P = .21 ) and 4 weeks ( P = .75 ) , showing no treatment effect .


Measured endogenous thrombin potential did not correlate with CTC number .


No bleeding-related serious adverse events ( SAEs ) occurred .


The baseline CTC numbers were lower than expected , decreasing the ability to detect an impact of platelet inhibition on CTCs .


Clopidogrel and aspirin were well tolerated .


Future studies evaluating the potential therapeutic role of antiplatelet therapy in breast cancer remain of interest , and they may be informed by theseresults .


The Carotid Revascularization Endarterectomy Versus Stenting Trial was completed with a low stroke and death rate .


A lead-in series of patients receiving carotid artery stenting was used to select the physician-operators for the study , where performance was evaluated by complication rates and by peer review of cases .


Herein , we assess the potential contribution of statistical evaluation of complication rates .


The ability to discriminate between stent operators who can successfully meet the published guideline of < 3 % combined rate of stroke and death is calculated under the binomial distribution , based on a small consecutive case series ( n = 24 patients ) .


A criterion of 2 stroke or death events among the 24 patients ( < 8 % event rate ) was required of operators .


Setting such a high criterion , however , ensures an inability to exclude operators who can not meet the criteria .


In fact , if a good operator is defined as having a 2 % event rate and a poor operator as a 6 % event rate , even a series of 240 patients would ( on average ) still exclude 5.4 % of the good operators and include 4.6 % of the poor operators .


The low periprocedural event rates in the trial suggest success in separating skillful operators from less skillful .


However , it seems unlikely that statistical assessment of event rates in the lead-in contributed to successful selection , but rather successful selection was more likely because of peer review of subjective and other factors including patient volume and technical approaches .


http://www.clinicaltrials.gov .


Unique identifier : NCT00004732 .


The objective of the study was to compare long-term results of subtotal vs total abdominal hysterectomy for benign uterine diseases 14 years after hysterectomy , with urinary incontinence as the primary outcome measure .


This was a long-term follow-up of a multicenter , randomized clinical trial without blinding .


Eleven gynecological departments in Denmark contributed participants to the trial .


Women referred for benign uterine diseases who did not have contraindications to subtotal abdominal hysterectomy were randomized to subtotal ( n = 161 ) vs total ( n = 158 ) abdominal hysterectomy .


All women enrolled in the trial from 1996 to 2000 who were still alive and living in Denmark ( n = 304 ) were invited to answer the validated questionnaire used in prior 1 and 5 year follow-ups .


Hospital contacts possibly related to hysterectomy from 5 to 14 years postoperatively were registered from discharge summaries from all public hospitals in Denmark .


The results were analyzed as intention to treat and per protocol .


Possible bias caused by missing data was handled by multiple imputation .


The primary outcome was urinary incontinence ; the secondary outcomes were pelvic organ prolapse , constipation , pain , sexuality , quality of life ( Short Form-36 questionnaire ) , hospital contacts , and vaginal bleeding .


The questionnaire was answered by 197 of 304 women ( 64.8 % ) ( subtotal hysterectomy [ n = 97 ] [ 63.4 % ] ; total hysterectomy [ n = 100 ] [ 66.2 % ] ) .


Mean follow-up time was 14 years and mean age at follow-up was 60.1 years .


After subtotal abdominal hysterectomy , 32 of 97 women ( 33 % ) complained of urinary incontinence compared with 20 of 100 women ( 20 % ) after total abdominal hysterectomy 14 years after hysterectomy ( relative risk , 1.67 ; 95 % confidence interval , 1.02-2 .70 ; P = .035 ) .


After a multiple imputation analysis , this difference disappeared ( relative risk , 1.36 ; 95 % confidence interval , 0.86-2 .13 ; P = .19 ) .


No differences were seen in any of the secondary outcomes .


Subtotal abdominal hysterectomy was not superior to total abdominal hysterectomy on any outcomes .


More women seem to have subjective urinary incontinence 14 years after subtotal abdominal hysterectomy .


This result was not confirmed by multiple imputation analysis and should be interpreted cautiously .


Enterococci , the second leading cause of health care-associated infections , have evolved from commensal and harmless organisms to multidrug-resistant bacteria associated with a significant increase in patient morbidity and mortality .


Prevention of ongoing spread of this organism within and between hospitals is important .


In this study , we characterized Enterococcus transmission dynamics for bacterial reservoirs commonly encountered by anesthesia providers during the routine administration of general anesthesia .


Enterococcus isolates previously obtained from bacterial reservoirs frequently encountered by anesthesiologists ( patient nasopharynx and axilla , anesthesia provider hands , and the adjustable pressure-limiting valve and agent dial of the anesthesia machine ) at 3 major academic medical centers were identified as possible intraoperative bacterial transmission events by class of pathogen , temporal association , and phenotypic analysis ( analytical profile indexing ) .


They were then subjected to antibiotic disk diffusion sensitivity for transmission event confirmation .


Isolates involved in confirmed transmission events were further analyzed to characterize the frequency , mode , origin , location of transmission events , and antibiotic susceptibility of transmitted pathogens .


Three hundred eighty-nine anesthesia reservoir isolates were previously identified by gross morphology and simple rapid tests as Enterococcus .


The combination of further analytical profile indexing analysis and temporal association implicated 43 % ( 166/389 ) of those isolates in possible intraoperative bacterial transmission events .


Approximately , 30 % ( 49/166 ) of possible transmission events were confirmed by additional antibiotic disk diffusion analysis .


Two phenotypes , E5 and E7 , explained 80 % ( 39/49 ) of confirmed transmission events .


For both phenotypes , provider hands were a common reservoir of origin proximal to the transmission event ( 96 % [ 72/75 ] hand origin for E7 and 89 % [ 50/56 ] hand origin for E5 ) and site of transmission ( 94 % [ 16/17 ] hand transmission location for E7 and 86 % [ 19/22 ] hand transmission location for E5 ) .


Anesthesia provider hand contamination is a common proximal source and transmission location for Enterococcus transmission events in the anesthesia work area .


Future work should evaluate the impact of intraoperative hand hygiene improvement strategies on the dynamics of intraoperative Enterococcus transmission .


To describe quantitative and qualitative features of eyes with advanced bullous keratopathy assessed using ultrasound biomicroscopy , before and after anterior stromal puncture ( ASP ) or amniotic membrane transplantation ( AMT ) procedures to relieve chronic pain .


The present descriptive comparative study included 40 eyes of 40 patients with chronic intermittent pain due to bullous keratopathy who were randomly assigned to one of the two treatments ( AMT or ASP ) .


Ultrasound biomicroscopy ( Humphrey , UBM 840 , 50 MHz transducer , immersion technique ) was used , and a questionnaire about pain intensity was completed preoperatively and postoperatively at days 90 and 180 , respectively .


Exclusion criteria were age < 18 years , presence of concurrent infection , ocular hypertension , and absence of pain .


In a 180-day follow-up , the AMT group exhibited mean central corneal thickness ( CCT ) , 899.4 m preoperatively and 1122.5 m postoperatively ( p < 0.001 ) ; mean epithelial thickness ( ET ) , 156.4 m preoperatively and 247.8 m postoperatively ( p < 0.001 ) ; and mean stromal thickness ( ST ) , 742.9 m preoperatively and 826.3 m postoperatively ( p = 0.005 ) .


The ASP group exhibited mean CCT , 756.7 m preoperatively and 914.8 m postoperatively ( p < 0.001 ) ; mean ET , 102.1 m preoperatively and 245.2 m postoperatively ( p < 0.001 ) ; and mean ST , 654.6 m preoperatively and 681.5 m postoperatively ( p < 0.999 ) .


Correlations between CCT and pain intensity in the AMT group ( p = 0.209 pre - and postoperatively ) and the ASP group ( p = 0.157 preoperatively and p = 0.426 at the 180-day follow-up ) were not statistically significant .


Epithelial and stromal edema , Descemet 's membrane folds , epithelial bullae , and the presence of interface fluid were frequently observed qualitative features .


CCT increased over time in both groups .


The magnitude of CCT did not correlate with pain intensity in the sample studied .


The presence of interface fluid was a qualitative feature specifically found in some patients who underwent AMT .


The association between low birthweight ( LBW ) and risk of developing type 2 diabetes may involve epigenetic mechanisms , with skeletal muscle being a prime target tissue .


Differential DNA methylation patterns have been observed in single genes in muscle tissue from type 2 diabetic and LBW individuals , and we recently showed multiple DNA methylation changes during short-term high-fat overfeeding in muscle of healthy people .


In a randomised crossover study , we analysed genome-wide DNA promoter methylation in skeletal muscle of 17 young LBW men and 23 matched normal birthweight ( NBW ) men after a control and a 5 day high-fat overfeeding diet .


DNA methylation was measured using Illumina 's Infinium BeadArray covering 27,578 CpG sites representing 14,475 different genes .


After correction for multiple comparisons , DNA methylation levels were found to be similar in the LBW and NBW groups during the control diet .


Whereas widespread DNA methylation changes were observed in the NBW group in response to high-fat overfeeding , only a few methylation changes were seen in the LBW group ( ( 2 ) , p < 0.001 ) .


Our results indicate lower DNA methylation plasticity in skeletal muscle from LBW vs NBW men , potentially contributing to understanding the link between LBW and increased risk of type 2 diabetes .


To investigate the efficacy and safety of ulipristal acetate ( UPA ) for long-term treatment of symptomatic uterine fibroids .


Repeated intermittent open-label UPA courses , each followed by randomized double-blind norethisterone acetate ( NETA ) or placebo .


European clinical gynecology centers .


Two hundred and nine women with symptomatic fibroids including heavy menstrual bleeding .


Patients received up to four 3-month courses of UPA 10 mg daily , immediately followed by 10-day double-blind treatment with NETA ( 10 mg daily ) or placebo .


Amenorrhea , fibroid volume , endometrial histology .


After the first UPA course , amenorrhea occurred in 79 % of women , with median onset ( from treatment start ) of 4 days ( interquartile range , 2-6 days ) .


Median fibroid volume change was -45 % ( interquartile range , -66 % ; -25 % ) .


Amenorrhea rates were 89 % , 88 % , and 90 % for the 131 , 119 , and 107 women who received treatment courses 2 , 3 , and 4 , respectively .


Median times to amenorrhea were 2 , 3 , and 3 days for treatment courses 2 , 3 , and 4 , respectively .


Median fibroid volume changes from baseline were -63 % , -67 % , and -72 % after treatment courses 2 , 3 , and 4 , respectively .


All endometrial biopsies showed benign histology without hyperplasia ; NETA did not affect fibroid volume or endometrial histology .


Repeated 3-month UPA courses effectively control bleeding and shrink fibroids in patients with symptomatic fibroids .


ClinicalTrials.gov ( www.clinicaltrials.gov ) registration numbers NCT01156857 ( PEARL III ) and NCT01252069 ( PEARL III extension ) .


To evaluate the prevalence of metabolic syndrome ( MetS ) and its association with physical capacity , disability , and self-rated health in older adults at high risk of mobility disability , including those with and without diabetes mellitus .


Cross-sectional analysis .


Lifestyle Interventions and Independence for Elders ( LIFE ) Study .


Community-dwelling sedentary adults aged 70 to 89 at high risk of mobility disability ( Short Physical Performance Battery ( SPPB ) score 9 ; mean 7.4 1.6 ) ( N = 1,535 ) .


Metabolic syndrome was defined according to the 2009 multiagency harmonized criteria ; outcomes were physical capacity ( 400-m walk time , grip strength , SPPB score ) , disability ( composite 19-item score ) , and self-rated health ( 5-point scale ranging from excellent to poor ) .


The prevalence of MetS was 49.8 % in the overall sample ( 83.2 % of those with diabetes mellitus , 38.1 % of those without ) .


MetS was associated with stronger grip strength ( mean difference ( ) = 1.2 kg , P = .01 ) in the overall sample and in participants without diabetes mellitus and with poorer self-rated health ( = 0.1 kg , P < .001 ) in the overall sample only .


No significant differences were found in 400-m walk time , SPPB score , or disability score between participants with and without MetS , in the overall sample or diabetes mellitus subgroups .


Metabolic dysfunction is highly prevalent in older adults at risk of mobility disability , yet consistent associations were not observed between MetS and walking speed , lower extremity function , or self-reported disability after adjusting for known and potential confounders .


Longitudinal studies are needed to investigate whether MetS accelerates declines in functional status in high-risk older adults and to inform clinical and public health interventions aimed at preventing or delaying disability in this group .


To verify the clinical efficacy on chronic fatigue syndrome of qi deficiency syndrome treated with acupuncture at selective time and explore the effect mechanism .


Eighty patients were randomized into a selective-time-acupuncture group and an acupuncture group , 40 cases in each one .


Qihai ( CV 6 ) , Guanyuan ( CV 4 ) , Hegu ( LI 4 ) , Taichong ( LR 3 ) , Sanyinjiao ( SP 6 ) and Zusanli ( ST 36 ) were selected in the two groups .


In the selective-time-acupuncture group , acupuncture was used at 9:00 am to 11:00 am .


In the acupuncture group , acupuncture was used at any time except in the range from 9:00 am to 11:00 am .


No any manipulation was applied after the arrival of needling sensation .


The treatment was given once every day , 10 day treatment made one session and two sessions of treatment were required .


The fatigue scale was adopted to evaluate the efficacy before and after treatment in the patients of the two groups .


The ratios among CD3 + , CD4 + and CD8 + T cells in the peripheral blood were detected before ad b a after treatment .


In the acupuncture group , the total score of fatigue and the score of physical fatigue were reduced after treatment as compared with those before treatment ( all P < 0.05 ) .


In the selective-time - acupuncture group , the total score of fatigue , the s core of physical fatigue and the score of mental fatigue after treatment were reduced obviously as compared with those hefore treatment ( all P < 0.01 ) .


The improvements in the scores of the selective-time-acupuncture group were superior to the acupuncture group ( all P < 0.05 ) .


The ratio of CD3 + and CD8 + T cells was increased obviously after treatment in the two groups ( all P < 0.05 ) and the ratio of CD4 + and CD8 + T cells was reduced obviously in the selective-time-acupuncture group ( P < 0.05 ) , which was better than that in the acupuncture group ( all P < 0.05 ) .


The total effective rate was 95.0 % ( 38/40 ) in the selective-time-acupuncture group , which was better than 80.0 % ( 32/40 ) in the acupuncture group ( P < 0.05 ) .


The acupuncture therapy at selective time is effective in the treatment of chronic fatigue syndrome of qi deficiency syndrome , which is especially better at relieving mental fatigue .


The effect of this therapy is achieved probably by improving the immune function via the regulation of the ratios among CD3 + , CD4 + and CD8 + T cells .


To understand whether using oral contraceptive pills ( OCPs ) results in temporary interruption of bleeding for etonogestrel contraceptive implant users during a 14-day course .


In this double-blind trial , we randomly assigned etonogestrel implant users reporting 7 consecutive days or more of bothersome bleeding to receive 14 pills of study drug ( 150 microgram levonorgestrel and 30 microgram ethinyl estradiol combined OCPs ) or an identical-appearing placebo .


The primary outcome was the proportion of women in each group who stopped bleeding during therapy and continued to report no bleeding at the end of therapy .


Prespecified secondary outcomes were number of days until temporary interruption of bleeding occurred , number of days without bleeding during therapy , and number of days to recurrence of bleeding after discontinuation of therapy .


We hypothesized that temporary interruption of bleeding would occur in 80 % of the treatment group compared with 20 % in the control group ; using 80 % power , we needed a sample size of 26 women .


We performed intent-to-treat analysis .


From November 2013 through December 2014 , 66 women were screened and 32 were randomized : OCPs ( n = 16 ) or placebo ( n = 16 ) .


The majority was young , Caucasian women with reported bleeding as extremely or very annoying ; groups had similar baseline characteristics .


Participants randomized OCPs were more likely ( 14 of 16 [ 87.5 % 16.2 % ] compared with six of 16 [ 37.5 % 23.7 % ] ) to have a temporary interruption of bleeding during the study drug period ( odds ratio 11.7 , 95 % confidence interval 1.9-70 .2 ) .


Of women in the OCP arm who had a temporary interruption , 85.7 % had bleeding recurrence within 10 days after treatment .


Bothersome bleeding in etonogestrel contraceptive implant users will usually stop with 14-day OCP treatment , but bleeding most often resumes within days of treatment cessation .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT01968135 .


I.


Examine longitudinal associations between sources of social support and social undermining for healthy eating and physical activity and weight change .


Data are from 633 employed adults participating in a cluster-randomized multilevel weight gain prevention intervention .


Primary predictors included social support and social undermining for two types of behaviors ( healthy eating and physical activity ) from three sources ( family , friends , and coworkers ) obtained via self-administered surveys .


The primary outcome ( weight in kg ) was measured by trained staff .


Data were collected at baseline , 12 months , and 24 months .


Linear multivariable models examined the association of support and social undermining with weight over time , adjusting for intervention status , time , gender , age , education , and clustering of individuals within schools .


Adjusting for all primary predictors and covariates , friend support for healthy eating ( = -0.15 ) , coworker support for healthy eating ( = -0.11 ) , and family support for physical activity ( = -0.032 ) were associated with weight reduction at 24 months ( P-values < 0.05 ) .


Family social undermining for healthy eating was associated with weight gain at 24 months ( = 0.12 ; P = 0.0019 ) .


Among adult employees , friend and coworker support for healthy eating and family support for physical activity predicted improved weight management .


Interventions that help adults navigate family social undermining of healthy eating are warranted .


We assessed the impact of hot flashes and various forms of hormone therapy on health-related quality of life and sexual well-being in recently postmenopausal women .


We prospectively interviewed 150 healthy women about hot flashes and health-related quality of life ( using the Women 's Health Questionnaire and the McCoy Female Sexuality Questionnaire ) , menopause-related symptoms , and general health .


The women were classified into those with ( n = 72 ) and without ( n = 78 ) hot flashes and treated for 6 months with transdermal estradiol ( 1 mg/d ) , oral estradiol ( 2 mg/d ) with or without medroxyprogesterone acetate ( 5 mg/d ) , or placebo .


At baseline , hot flashes contributed most strongly to poor sleep ( correlation coefficient r = -0.525 , P < 0.0001 ) , somatic symptoms such as muscle pains ( r = -0.348 , P < 0.0001 ) , menstrual cycle-resembling complaints ( r = -0.304 , P < 0.0001 ) , anxiety and fears ( r = -0.283 , P < 0.0001 ) , decreased memory and concentration ( r = -0.279 , P = 0.001 ) , and sexual behavior ( r = -0.174 , P = 0.035 ) .


The different hormone therapy regimens alleviated hot flashes equally effectively and were therefore combined into a single group for further analysis .


In women with baseline flashes , hormone therapy use significantly improved the scores for sleep ( 0.787 [ 0.243 ] vs 0.557 [ 0.249 ] , hormone therapy vs placebo , P = 0.001 , at 6 mo ) , memory and concentration capacity ( 0.849 [ 0.228 ] vs 0.454 [ 0.301 ] , P < 0.0001 , at 6 mo ) , and anxiety and fears ( 0.942 [ 0.133 ] vs 0.826 [ 0.193 ] , P = 0.005 , at 6 mo ) .


Hormone therapy use showed no significant impact on these variables in women without baseline flashes .


Hot flashes contribute differently to various variables affecting health-related quality of life shortly after menopause .


Estradiol or an estradiol-medroxyprogesterone acetate combination similarly alleviates hot flashes and improves health-related quality of life in relation to elimination of hot flashes .


Hormone therapy use does not confer any detectable quality-of-life benefit over placebo in women without disturbing baseline flashes .


A restricted sympathetic block during spinal anesthesia may minimize hemodynamic changes .


This prospective randomized study compared unilateral and bilateral spinal anesthesia with respect to the intra - and postoperative advantages and complications of each technique .


Spinal anesthesia was induced with 0.5 % hyperbaric bupivacaine and a 25-G Quincke needle ( Dr. J ) in two groups of patients with physical status ASA I-II who had been admitted for orthopedic surgeries .


In group A , dural puncture was performed with the patient in a seated position using 2.5 cm ( 3 ) of hyperbaric bupivacaine .


Each patient was then placed in the supine position .


In group B , dural puncture was performed with the patient in the lateral decubitus position with 1.5 cm ( 3 ) of hyperbaric bupivacaine .


The lower limb was the target limb .


The speed of injection was 1 mL/30s , and the duration of time spent in the lateral decubitus position was 20 min .


The demographic data were similar in both groups .


The time to the onset of the sensory and motor block was significantly shorter in group A ( p = 0.00 ) .


The duration of motor and sensory block was shorter in group B ( p < 0.05 ) .


The success rate for unilateral spinal anesthesia in group B was 94.45 % .


In two patients , the spinal block spread to the non-dependent side .


The incidence of complications ( nausea , headache , and hypotension ) was lower in group B ( p = 0.02 ) .


When unilateral spinal anesthesia was performed using a low-dose , low-volume and low-flow injection technique , it provides adequate sensory-motor block and helps to achieve stable hemodynamic parameters during orthopedic surgery on a lower limb .


Patients were more satisfied with this technique as opposed to the conventional approach .


Furthermore , this technique avoids unnecessary paralysis on the non-operated side .


This study aimed to establish the noninferiority of a single-freeze application with CO2 or N2O compared with the standard double freeze with N2O for cryotherapy treatment .


Sixty women undergoing hysterectomy for reasons other than cervical cancer or precancer were randomized to 1 of 3 techniques as follows : ( 1 ) double freeze with N2O , ( 2 ) single freeze with N2O , or ( 3 ) single freeze with CO2 .


The cervix was separated and cut into anterior and posterior segments , and the deepest area of necrosis was recorded .


Comparisons were made using regression analysis .


The margin of noninferiority was defined as 0.8 mm .


On the anterior lip , a single freeze with N2O was noninferior to a double freeze of the same gas , but on the posterior lip , the single freeze was not .


The single freeze of CO2 did not provide sufficient depth of necrosis in either lip to infer noninferiority versus the double freeze with N2O .


A single freeze with N2O is noninferior to a double-freeze technique in the anterior but not the posterior lip .


However , the result for posterior lips was close to reaching statistical significance .


In addition , CO2 had approximately 1 mm shallower depth of necrosis compared with N2O techniques ; however , the clinical implications are unknown .


Given the extensive use of CO2 globally , further clinical evaluation is needed .


Vitamin D repletion with high doses of vitamin D is often recommended to patients and healthy subjects .


The safety , especially concerning changes in urinary calcium excretion is of great importance .


In a double-blinded , placebo-controlled study in 40 healthy volunteers , we examined the changes in mineral metabolism during supplementation with 3000 IU of oral cholecalciferol daily during 4 months .


Both 25 ( OH ) vitamin D and 1,25 ( OH ) 2vitamin D increased significantly in the active treated group as compared to the placebo group ( 186 % versus 14 % ( P < 0.001 ) and 28 % versus -8 % ( P < 0.001 ) ) .


No change was observed in urinary calcium excretion in the active group compared to the placebo group ( P = 0.891 ) .


Fibroblast growth factor 23 increased significantly by 10 % ( P < 0.018 ) in the active group .


However , there was no difference in changes in FGF23 between treatment groups ( P = 0.457 ) .


High dose cholecalciferol significantly increases 25 ( OH ) vitamin D and 1,25 ( OH ) 2vitamin D levels compared to placebo .


No changes in urinary calcium excretion or other measured components of the mineral metabolism were found between groups .


ClinicalTrials.gov NCT00952562 .


The present study analyses the relation between smoking status and the parameters used to assess vascular structure and function .


This cross-sectional , multi-centre study involved a random sample of 1553 participants from the EVIDENT study .


The smoking status , peripheral augmentation index and ankle-brachial index were measured in all participants .


In a small subset of the main population ( 265 participants ) , the carotid intima-media thickness and pulse wave velocity were also measured .


After controlling for the effect of age , sex and other risk factors , present smokers have higher values of carotid intima-media thickness ( p = 0.011 ) .


Along the same lines , current smokers have higher values of pulse wave velocity and lower mean values of ankle-brachial index but without statistical significance in both cases .


Among the parameters of vascular structure and function analysed , only the IMT shows association with the smoking status , after adjusting for confounders .


Children in Sub-Saharan Africa ( SSA ) are burdened by significant unmet mental health needs , but this region has limited access to mental health workers and resources to address these needs .


Despite the successes of numerous school-based interventions for promoting child mental health , most evidence-based interventions are not available in SSA .


This study will investigate the transportability of an evidence-based program from a developed country ( United States ) to a SSA country ( Uganda ) .


The approach includes task-shifting to early childhood teachers and consists of professional development ( five days ) to introduce strategies for effective behavior management and positive teacher-student interactions , and group-based consultation ( 14 sessions ) to support adoption of effective practices and tailoring to meet the needs of individual students .


The design of this study is guided by two implementation frameworks , the Consolidated Framework for Implementation Research and the Teacher Training Implementation Model , that consider multidimensional aspects of intervention fidelity and contextual predictors that may influence implementation and teacher outcomes .


Using a cluster randomized design , 10 schools in Uganda will be randomized to either the intervention group ( five schools ) or the waitlist control group ( five schools ) .


A total of 80 to 100 early childhood teachers will be enrolled in the study .


Teacher utilization of evidence-based strategies and practices will be assessed at baseline , immediate post-intervention ( six months after baseline ) , and at seven months post-intervention ( during a new academic year ) .


Fidelity measures will be assessed throughout the program implementation period ( during professional development and consultation sessions ) .


Individual teacher and contextual factors will be assessed at baseline .


Data will be collected from multiple sources .


Linear mixed-effect modeling , adjusting for school nesting , will be applied to address study questions .


The study will produce important information regarding the value of an evidence-based early intervention , and a theory-guided implementation process and tools designed for use in implementing early childhood evidence-based programs in SSA countries or resource-constrained community settings .


This trial was registered with ClinicalTrials.gov ( registration number : NCT097115 ) on 15 May 2013 .


Soft-tissue augmentation with fillers is an aesthetic procedure for restoring age-related volume loss .


To compare neocollagenesis and elastin production stimulated by Radiesse ( calcium hydroxylapatite ; CaHA , Merz Pharmaceuticals GmbH ) and a hyaluronic acid-based filler ( HA ; Juvderm VOLUMA ) .


Twenty-four women , aged 35-45 , participated in this split-face , comparative study .


Punch biopsies were taken 4 and 9 months after supraperiostal injection of each filler into the ipsilateral or contralateral postauricular area .


Samples were analyzed for collagens type I and III , elastin , Ki-67 , and inflammatory and angiogenic markers .


At month 4 , collagen type III was greater with CaHA vs HA ( P = 0.0052 ) .


By month 9 , type I staining was higher with CaHA vs HA ( P = 0.0135 ) , whereas type III was lower with CaHA than HA ( P = 0.0019 ) .


Staining for elastin , Ki-67 and angiogenesis was greatest with CaHA at both timepoints .


Inflammatory markers increased most with HA treatment .


CaHA resulted in more active , physiologic remodeling of the extracellular matrix than HA by stimulating a two-step process whereby collagen type I gradually replaced type III .


Increased elastin stimulated by CaHA also indicates active remodeling .


The results of this study suggest that , in the first 9 months after treatment , by reconstituting tissue homeostasis without inducing inflammation suggests CaHA has more desirable characteristics for a dermal filler than HA .


Experimental evidence suggests that the inhalational anesthetic sevoflurane has a cardioprotective effect .


Our objective was to determine if sedation with sevoflurane will reduce infarct size in patients with acute myocardial infarction ( MI ) who are treated with primary percutaneous coronary intervention ( PCI ) .


We randomized 50 patients presenting with a first acute ST-elevation MI treated by primary PCI within 6 hours from symptom onset to sedation with sevoflurane inhalation or standard sedation ( control ) .


Coronary flow at the end of PCI was assessed by corrected Thrombolysis In Myocardial Infarction frame count .


Myocardial reperfusion was assessed by ST-segment resolution 60 minutes post-PCI .


Infarct size was assessed by release of creatinine kinase ( CK ) and troponin T.


There was no difference in the primary end point : troponin T or CK release adjusted to the area at risk , between groups .


However , among patients with anterior MI , there was a trend toward lower CK ( P = .05 ) and nonsignificant decrease in troponin ( P = .11 ) levels in the sevoflurane group .


Corrected Thrombolysis In Myocardial Infarction frame count was 12.3 1.5 in the sevoflurane group and 15.6 9.1 in the control group ( P = .16 ) .


There was more ST resolution in patients treated by sevoflurane 80.7 % 25.8 % versus 56.6 % 35.7 % ( P = .01 ) .


Sevoflurane had no significant adverse effect during administration .


Sevoflurane administration during primary PCI did not reduce infarct size .


There was a trend toward a reduction in infarct size among patients with anterior MI .


Sevoflurane administration was associated with improvement in ST-segment resolution .


To compare a motivational intervention ( MI ) focused on increasing involvement in 12-Step groups ( TSGs ; e.g. Alcoholics Anonymous ) versus brief advice ( BA ) to attend TSGs .


Patients were assigned randomly to either the MI or BA condition , and followed-up at 6 months after discharge .


One hundred and forty substance use disorder ( SUD ) patients undergoing in-patient detoxification ( detox ) in Norway .


The primary outcome was TSG affiliation measured with the Alcoholics Anonymous Affiliation Scale ( AAAS ) , which combines meeting attendance and TSG involvement .


Substance use and problem severity were also measured .


At 6 months after treatment , compared with the BA group , the MI group had higher TSG affiliation [ 0.91 point higher AAAS score ; 95 % confidence interval ( CI ) = 0.04 to 1.78 ; P = 0.041 ] .


The MI group reported 3.5 fewer days of alcohol use ( 2.1 versus 5.6 days ; 95 % CI = -6.5 to -0.6 ; P = 0.020 ) and 4.0 fewer days of drug use ( 3.8 versus 7.8 days ; 95 % CI = -7.5 to -0.4 ; P = 0.028 ) ; however , abstinence rates and severity scores did not differ between conditions .


Analyses controlling for duration of in-patient treatment did not alter the results .


A motivational intervention in an in-patient detox ward was more successful than brief advice in terms of patient engagement in 12-Step groups and reduced substance use at 6 months after discharge .


There is a potential benefit of adding a maintenance-focused element to standard detox .


To compare epithelial connective tissue graft vs porcine collagen matrix for sealing postextraction sockets grafted with deproteinised bovine bone .


A total of 30 patients , who needed a maxillary tooth to be extracted between their premolars and required a delayed , fixed , single implant-supported restoration , had their teeth atraumatically extracted and their sockets grafted with deproteinised bovine bone .


Patients were randomised according to a parallel group design into two arms : socket sealing with epithelial connective tissue graft ( group A ) vs porcine collagen matrix ( group B ) .


Outcome measures were : implant success and survival rate , complications , horizontal and vertical alveolar bone dimensional changes measured on Cone Beam computed tomography ( CBCT ) scans at three levels localised 1 , 3 , and 5 mm below the most coronal aspect of the bone crest ( levels A , B , and C ) ; and between the palatal and buccal wall peaks ( level D ) ; and peri-implant marginal bone level changes measured on periapical radiographs .


15 patients were randomised to group A and 15 to group B. No patients dropped out .


No failed implants or complications were reported 1 year after implant placement .


Five months after tooth extraction there were no statistically significant differences between the 2 groups for both horizontal and vertical alveolar bone dimensional changes .


At level A the difference was 0.13 0.18 ; 95 % CI 0.04 to 0.26 mm ( P = 0.34 ) , at level B it was 0.08 0.23 ; 95 % CI -0.14 to 0.14 ( P = 0.61 ) , at level C it was 0.05 0.25 ; 95 % CI -0.01 to 0.31 mm ( P = 0.55 ) and at level D it was 0.13 0.27 ; 95 % CI -0.02 to 0.32 mm ( P = 0.67 ) .


One year after implant placement there were no statistically significant differences between the 2 groups for peri-implant marginal bone level changes ( difference : 0.07 0.11 mm ; 95 % CI -0.02 to 0.16 ; P = 0.41 ) .


When teeth extractions were performed atraumatically and sockets were filled with deproteinised bovine bone , sealing the socket with a porcine collagen matrix or a epithelial connective tissue graft showed similar outcomes .


The use of porcine collagen matrix allowed simplification of treatment because no palatal donor site was involved .


Standard treatment for patients with chronic hepatitis C genotype 1 ( CHC G-1 ) infection includes pegylated interferon plus ribavirin ( PEG-RBV ) for 48 weeks .


Shorter treatment regimen would be more acceptable due to lower cost and fewer side-effects .


We aimed to compare the efficacy of 36 week PEG-RBV therapy with standard 48 week therapy in CHC G-1 patients who achieve complete early virological response ( cEVR ) .


Consecutive treatment-nave patients with CHC G-1 were treated with pegylated interferon a2b ( 1.5 g/kg/week ) or 2a ( 180 g/week ) and weight based ribavirin .


Patients who achieved cEVR at 12 weeks [ undetectable HCV RNA irrespective of RVR ( rapid virological response ) ] were randomized into - group A ( 48 weeks therapy ) and group B ( 36 weeks therapy ) .


Primary end-point was achievement of sustained virological response ( SVR ) at 24 weeks of follow up .


Out of the total 166 patients started on treatment , 112 ( 69.3 % ) achieved cEVR , and were randomized into group A ( n = 59 ) and group B ( n = 53 ) .


Fifty-five ( 93.2 % ) patients in group A and 50 ( 94.3 % ) in group B completed therapy .


The overall SVR rate in group A was 79.6 % ( 47/59 ) and group B was 84.9 % ( 45/53 ) ( p = 0.622 ) .


SVR rates in the two groups were comparable in all patient sub-groups according to factors like viral load ( or > 400,000 IU/mL ) , RVR ( achieved/not achieved ) , age ( or > 40 years ) , body mass index ( or > 27 ) and cirrhosis ( present/absent ) .


In CHC G-1 patients who achieve cEVR , 36 weeks PEG-RBV therapy is as effective as standard 48 weeks therapy , irrespective of other host or virological factors .


To compare the analgesic efficacy of 2 types of anesthetic techniques-topical and topical associated with cryoanalgesia-during cataract surgery .


Department of Ophthalmology , University of So Paulo , Ribeiro Preto , Brazil .


Prospective randomized study .


Patients with symmetrical bilateral cataract had phacoemulsification with the use of an intraocular irrigation solution at room temperature in 1 eye and a cold ( 4C ) solution in the contralateral eye ( Group 2 ) .


The pain related to the procedure was assessed using a visual analog scale ranging from 0 to 100 , with 0 representing no pain and 100 the worst pain .


In addition , endothelial cell loss , the change in corneal thickness , and visual acuity were evaluated 30 days 2 ( SD ) after each surgery .


The surgery duration , total irrigation volume , phacoemulsification time , and ultrasound power used were analyzed .


The study enrolled 25 patients ( 50 eyes ) .


There was no statistically significant difference in the mean pain score between Group 1 ( 26.0 3.7 ) and Group 2 ( 21.3 3.6 ) ( P = .2016 , paired t test ) .


No significant difference was found in the mean corneal endothelial cell loss ( Group 1 : 10.0 % 0.4 % ; Group 2 : 9.9 % 0.3 % ; P = .7576 ) , corneal thickness increase ( Group 1 : 1.5 1.0 m ; Group 2 : 1.4 0.9 m ; P = .9340 ) , or visual acuity gain ( Group 1 : 0.54 0.06 logMAR ; Group 2 : 0.55 0.09 logMAR ; P = .8208 ) .


There is no difference in the intensity of pain during phacoemulsification with the use of topical anesthesia or topical anesthesia associated with cryoanalgesia .


No author has a financial or proprietary interest in any material or method mentioned .


To assess the effectiveness of acupuncture combined with selective serotonin reuptake inhibitors ( SSRIs ) for patients with depression in hospital using a pragmatic randomised controlled trial .


76 patients with depression were randomly divided into two groups ( randomisation ratio 2:1 for treatment and control groups ( CGs ) , respectively ) and 71 patients completed the study .


The 45 patients in the treatment group ( TG ) underwent acupuncture and received an SSRI and the 26 patients in the CG received an SSRI only .


The 17-item Hamilton Depression Rating Scale ( HDRS-17 ) was used to quantitatively assess patients after 1 , 2 , 4 and 6weeks of treatment .


The mean ( SD ) baseline total HDRS scores were 22.2 ( 0.60 ) and 22.1 ( 0.33 ) in the TG and CG , respectively .


After the first week of treatment the HDRS score for the TG was reduced to 15.6 ( 0.81 ) , significantly different from the score of 18.3 ( 0.55 ) for the CG , p < 0.05 .


This significant difference was maintained to the end of the 6-week treatment period , when HDRS scores had fallen to 6.3 ( 0.49 ) and 8.2 ( 0.35 ) for the TG and CG , respectively .


Acupuncture combined with an SSRI showed a statistically significant benefit for patients with depression in hospital over the 6-week period compared with SSRIs alone .


This reduction in symptoms started in the first week and continued throughout the 6weeks of treatment .


The aim of this study was to evaluate the population pharmacokinetics ( PK ) and exposure-response relationship of edoxaban in patients with non-valvular atrial fibrillation ( AF ) .


Concentration data from 1,134 subjects in 11 clinical studies ( eight phase I , one phase II , and two phase III ) were used to perform a population PK analysis , including estimation of the bioavailability and quantification of the effects of P-glycoprotein ( P-gp ) inhibitors as well as renal impairment on edoxaban PK .


The potential relationship between edoxaban PK exposure and incidence of bleeding events was explored based on data from 893 AF patients .


Absolute bioavailability of edoxaban was estimated as 58.3 % .


With oral dosing of edoxaban , co-administration of various P-gp inhibitors significantly increased edoxaban bioavailability and decreased volume of distribution ( V 2 ) , resulting in a predicted increase of 33-77 % in area under the curve ( AUC ) and 65-104 % in C max .


A much smaller increase was seen in edoxaban concentration at 24 h post-dose ( C 24 , -24 to 38 % ) , due to decreased V 2 and shortened elimination half-life .


With IV dosing of edoxaban , co-administration of the P-gp inhibitor quinidine decreased both edoxaban clearance ( CL ) and V 2 , resulting in an increase of 32 % in AUC and 66 % in C 24 .


Creatinine clearance was a significant covariate on renal clearance , whereas age and body weight significantly affected nonrenal clearance .


Model-predicted steady state C min was slightly higher , but AUC was comparable for patients who had severe renal impairment and received edoxaban 15 mg once daily ( QD ) versus patients who had normal renal function or mild renal impairment and received edoxaban 30 mg QD .


Exposure-response analysis suggested that edoxaban C min and country/region are significantly associated with the incidence of bleeds .


The model provided reasonable estimation with regard to the absolute bioavailability of edoxaban , the magnitude of change in edoxaban exposure upon co-administration of P-gp inhibitors , and the impact of renal impairment on edoxaban clearance .


Analysis results supported a 50 % dose reduction scheme for subjects with severe renal impairment .


Further confirmation will be sought by incorporating clinical safety and efficacy information from larger phase III trials .


We sought to determine if outcomes with exercise training in heart failure ( HF ) vary according to ventricular pacing type .


Heart Failure : A Controlled Trial Investigating Outcomes of Exercise Training ( HF-ACTION ) randomized 2,331 outpatients with HF and left ventricular ejection fraction 35 % to usual care plus exercise training or usual care alone .


We examined the relationship between outcomes and randomized treatment according to ventricular pacing status with the use of Cox proportional hazards modeling .


In HF-ACTION 1,118 patients ( 48 % ) had an implanted cardiac rhythm device : 683 with right ventricular ( RV ) and 435 with biventricular ( BiV ) pacemakers .


Patients with pacing devices were older , more frequently white , and had lower peak VO2 ( P < .001 for all ) .


Peak VO2 improved similarly with training in groups with and without pacing devices .


The primary composite end point-all-cause death or hospitalization-was reduced only in patients randomized to exercise training without a device ( hazard ratio [ HR ] 0.79 , 95 % confidence interval [ CI ] 0.67-0 .93 [ P = .004 ] ; RV lead : HR 1.04 , 95 % CI 0.84-1 .28 [ P = .74 ] ; BiV pacing : HR 1.05 , 95 % CI 0.82-1 .34 [ P = .72 ] ; interaction P = .058 ) .


Exercise training may improve exercise capacity in patients with implanted cardiac devices .


However , the apparent beneficial effects of exercise on hospitalization or death may be attenuated in patients with implanted cardiac devices and requires further study .


Inhibition of dipeptidyl peptidase 4 ( DPP4 ) is thought to intensify the physiological effects of the incretin hormones .


We investigated the effects of DPP4 inhibition on plasma levels of glucose-dependent insulinotropic polypeptide ( GIP ) , glucagon-like peptide 1 ( GLP1 ) , incretin effect , glucose tolerance , gastrointestinal-mediated glucose disposal ( GIGD ) and gastric emptying in healthy subjects .


A randomised , controlled and open-labelled study .


Ten healthy subjects ( six women ; age , 405 years ( means.e.m . )