More importantly , treatment failure rate was significantly lower in the Jinzhen group ( @ % ) compared with that in the placebo group ( @ % ) ( P = @ ) .


The incidence of serious adverse events did not differ significantly between the two groups ( @ in Jinzhen group vs. @ in placebo , P = @ ) .


Children with HFMD may benefit from Jinzhen oral liquid treatment as compared with placebo .


This study examined overall changes in nicotine concentrations when using a popular e-cigarette and @ mg/mL nicotine e-Juice , and it further explored effects of sex and flavorings on these concentrations .


We recruited nontreatment-seeking smokers who were willing to try e-cigarettes for @ weeks and abstain from cigarette smoking .


Subjects were randomized to either menthol tobacco or non-menthol tobacco-flavored e-cigarette use for @-@ days , and the next week they were crossed over to the other condition .


On the last day of e-cigarette use of each flavor , subjects completed a laboratory session in which they used the e-cigarette for @ min ad libitum .


Nicotine concentrations were obtained @ min before and @ , @ , @ , @ , and @ min after the onset of e-cigarette use .


Twenty subjects completed at least @ monitoring session .


Nicotine concentrations significantly increased from baseline to @ min by @ ng/mL at the first laboratory session ( p < @ ) and by @ ng/mL at the second laboratory session ( p < @ ) .


Combining sessions , there were no main effects of sex or preferred flavor ( based on smoking history ) on changes in nicotine concentrations .


After adding preferred flavor , sex , and visit order to the model , there was a significant preferred flavor by sex interaction ( p < @ ) , such that women who received nonpreferred flavors had lower nicotine concentrations and rated their e-cigarette as less likeable ( p < @ ) .


We found nicotine concentrations significantly increase after e-cigarette use for @ min , and flavor may impact nicotine concentrations with e-cigarette use in women .


Depression is a common and disabling condition .


In Chile , assistance is guaranteed by law through a national program for depression in primary care services , and there is evidence of effective treatment for depressed women .


However , there is a shortage of evidence-based treatments for depression in adolescents .


The incorporation of technology to expand therapeutic options is becoming more common .


This proposal aims to compare the efficacy of therapy that enhances traditional face-to-face cognitive-behavioral therapy ( CBT ) with a computer-based program versus usual care to treat depression in adolescents in primary care clinics in Santiago , Chile .


This is a two-arm , single-blind , randomized controlled trial with a target enrollment of @ depressed adolescents between @ and @years of age , attending four primary care clinics in Santiago , Chile .


In the active arm , depressed adolescents will receive eight sessions of computer-assisted CBT , led by trained psychologists on a weekly basis .


In the control arm , depressed adolescents will receive treatment as usual from the primary care centers .


Mean depression scores and indicators of dysfunctional thoughts , problem-solving strategies , and health-related quality of life will be measured at baseline and four and six months after randomization .


As far as we know , this is the first randomized controlled trial of a computer-assisted CBT intervention for depressed adolescents in a Latin American country .


Fibromyalgia ( FM ) is a disease that causes widespread pain and increased sensitivity to pain because of a dysfunction in the central nervous system .


This study investigated the effect of music combined with vibration on acupuncture points for the treatment of FM .


A total of @ patients with FM were allocated randomly to four groups ( @ patients each ) .


One group listened to a sequence of Bach 's compositions .


The second group was subjected to vibratory stimuli on a combination of acupuncture points on the skin .


The third group ( complete ) underwent both procedures in a simultaneous and synchronized manner , with inclusion of binaural beats .


The fourth group ( control ) received no stimulation .


The participants underwent the experimental procedure during five sessions performed on alternate days .


They were assessed by the Fibromyalgia Impact Questionnaire ( FIQ ) and the Health Assessment Questionnaire ( HAQ ) before the first session and after the last session ( @ days ) .


All groups showed a significant improvement in FIQ and HAQ scores at the evaluation after the intervention .


The complete group exhibited the best result on both the FIQ and HAQ ( p < @ ) , and the improvement in HAQ score was significant ( p < @ ) .


The results suggest that the placebo effect in FM may be substantial .


However , comparison between groups revealed that the complete group had the greatest reduction in both FIQ and HAQ , with a significant improvement in HAQ , suggesting that the combined use of music and vibration exerts a greater effect on FM symptoms .


To determine whether the extruded irrigation solution bag during passage of rigid cystoscope will reduce the patient 's discomfort .


In the study , @ male patients undergoing rigid cystoscopies were randomized into `` Institute of Urology Peking University ( IUPU ) '' technique group ( n = @ ) and routine manipulation group ( n = @ ) .


All the patients had received @ mL oxybuprocaine gel before manipulation .


In the IUPU technique group , irrigation solution bag was connected with cystoscope sheath and obturator .


As the scope passed through the bulbar urethra , a nurse was instructed to extrude the irrigating fluid bag .


A @-point visual analog pain scale assessment was completed by the patient after the procedure .


The visual analog pain score was @ ( @-@ ) in the IUPU technique group and @ ( @-@ ) in the routine manipulation group ( P < @ , Mann-Whitney U test ) .


All the procedure indications had no effect on the findings .


This study has shown that a simple IUPU technique can significantly reduce the patient 's discomfort during outpatient rigid cystoscopy .


We strongly recommend this technique for all male patients undergoing rigid cystoscopy .


Contingency management ( CM ) treatment is effective for treating cocaine dependence but further mechanistic studies of its efficacy are warranted .


This study aimed to determine whether : ( a ) higher vs. lower predictable money amounts ( $ @ vs. $ @ ; analogs of standard voucher-based CM ) increase cocaine demand elasticity ; and ( b ) probabilistic amounts matched for expected value with the $ @-predictable amount ( @ % chance of $ @ ; @ % chance of $ @ ; and @ % chance of $ @ ; analogs of prize CM ) similarly affect cocaine choice .


Each of @ cocaine-dependent participants first completed a qualifying session to ensure that intranasal cocaine functioned as a reinforcer , then completed a @-session , within-subject , randomized crossover study .


During each of the @ sessions , the participant responded on a progressive ratio schedule to earn units of cocaine ( @-mg or @-mg ) and/or money ( five monetary conditions above ) .


During the reinforcement qualifying session ( @-mg vs. @-mg units ; no money alternative ) , cocaine choice was high .


The $ @-predictable amount significantly decreased cocaine choice relative to both the $ @-predictable amount and the qualifying session .


Cocaine-choices in the probabilistic conditions were similar to the $ @ predictable condition .


These findings indicate that CM interventions targeted at reducing cocaine self-administration are more likely to succeed with higher value non-drug reinforcement .


The purpose of this study was to evaluate associations between prescription drug misuse ( PDM ) and sexual risk behaviors ( SRBs ) among adolescents and emerging adults .


In a hospital emergency department , @,@ sexually active @ - to @-year-olds ( @ % female ) reported on past-year alcohol use severity ( using the Alcohol Use Disorders Identification Test-consumption -LSB- AUDIT-C -RSB- ) , cannabis use , PDM ( n = @ ) , and SRBs ( inconsistent condom use , multiple partners , intercourse following alcohol/other drug use ) .


Bivariately , AUDIT-C score , cannabis use , and PDM of stimulants , opioids , and sedatives were positively associated with each SRB .


Because many participants reported PDM for multiple drug classes ( i.e. , sedatives , stimulants , opioids ) , participants were categorized as ( a ) no PDM ( n = @,@ ) , ( b ) PDM of one class ( n = @ ) , ( c ) PDM of two classes ( n = @ ) , or ( d ) PDM of three classes ( n = @ ) .


Three hierarchical logistic regression models evaluated the associations of number of classes of PDM with SRBs separately , after accounting for demographics ( age , gender , race ) , AUDIT-C score , and cannabis use .


Adding PDM statistically improved each model beyond what was accounted for by demographics , alcohol , and cannabis use .


For inconsistent condom use and substance use before sex , PDM of one , two , or three classes was significantly associated with increased odds of these SRBs .


PDM of two or three classes was associated with increased odds of reporting multiple partners .


Findings suggest that PDM , especially poly-PDM , may be a pertinent risk factor for SRBs among youth .


Event-based research could further evaluate how PDM , as well as other substance use , is related to SRBs at the event level in order to inform interventions .


Synthetic colloids are often used during fluid resuscitation and affect coagulation .


To compare the effects of an isotonic crystalloid and synthetic colloid on coagulation in healthy dogs and dogs with systemic inflammation .


Sixteen adult purpose-bred Beagles .


Randomized , placebo-controlled , blinded study .


Dogs were randomized into one of two groups receiving fluid resuscitation with either @ mL/kg IV @ % NaCl or tetrastarch after administration of lipopolysaccharide or an equal volume of placebo .


After a @-day washout period , the study was repeated such that dogs received the opposite treatment ( LPS or placebo ) but the same resuscitation fluid .


Blood samples were collected at @ , @ , @ , @ , and @ hours for measurement of coagulation variables .


Administration of either fluid to healthy dogs and dogs with systemic inflammation resulted in similar increases in prothrombin time and activated clotting time .


In comparison to saline administration , tetrastarch administration resulted in significantly decreased R ( P = @ ) in healthy dogs , as well as significantly increased activated partial thromboplastin time ( P @ ) , CL@ % ( P @ ) , and K ( P < @ ) and significantly decreased platelet count ( P = @ ) , ( P @ ) , MA ( P < @ ) , and von Willebrand factor antigen ( P < @ ) and collagen binding activity ( P @ ) in both healthy dogs and dogs with systemic inflammation .


Tetrastarch bolus administration to dogs with systemic inflammation resulted in a transient hypocoagulability characterized by a prolonged activated partial thromboplastin time , decreased clot formation speed and clot strength , and acquired type @ von Willebrand disease .


To evaluate the reduction in phantom pain and sensation with combined training of progressive muscle relaxation , mental imagery , and phantom exercises .


Randomized controlled prospective trial with @ parallel groups .


Amputee unit of a rehabilitation hospital .


Subjects with unilateral lower limb amputation ( N = @ ) with phantom limb pain ( PLP ) and/or phantom limb sensation ( PLS ) .


The experimental group performed combined training of progressive muscle relaxation , mental imagery , and phantom exercises @ times/wk for @ weeks , whereas the control group had the same amount of physical therapy dedicated to the residual limb .


No pharmacological intervention was initiated during the trial period .


The Prosthesis Evaluation Questionnaire and the Brief Pain Inventory were used to evaluate changes over time in different aspects ( intensity , rate , duration , and bother ) of PLS and PLP .


Blind evaluations were performed before and after treatment and after @-month follow-up .


The experimental group showed a significant decrease over time in all the Prosthesis Evaluation Questionnaire domains ( in terms of both PLS and PLP ; P < @ for both ) and the Brief Pain Inventory ( P < @ ) .


No statistically significant changes were observed in the control group .


Between-group analyses showed a significant reduction in intensity ( average and worst pain ) and bother of PLP and rate and bother of PLS at follow-up evaluation , @ month after the end of the treatment .


Combined training of progressive muscle relaxation , mental imagery , and modified phantom exercises should be taken into account as a valuable technique to reduce phantom limb pain and sensation .


Anxiety among patients in a pediatric emergency department ( PED ) can be significant , but often goes unaddressed .


Our aim was to determine whether exposure to Child Life ( CL ) or hospital clowning ( HC ) can reduce anxiety in children presenting to a PED .


Patients were randomized to CL , HC , or control and assessed upon entry to examination room ( T@ ) , before physician arrival ( T@ ) , and during physician examination ( T@ ) , using the modified Yale Preoperative Anxiety Scale ( m-YPAS ) .


CL and HC interventions occurred for @ to @ min before physician entry .


Effects were analyzed using mixed analysis of variance .


m-YPAS scores ranged from @ to @ , with a higher score indicating increased anxiety .


Mixed analysis of variance on the study sample ( n = @ ) showed a significant interaction between groups ( CL , HC , control ) and time ( p = @ ) .


Additional analyses indicated effect of group only at T@ ( CL : mean = @ ; @ % confidence interval -LSB- CI -RSB- @-@ @ ; HC : mean @ ; @ % CI @-@ @ ; control : mean = @ ; @ % CI @-@ @ ; p = @ ) .


Subanalysis of patients with T@ m-YPAS score @ ( n = @ ) showed a significant interaction between group and time ( p = @ ) .


Additional analysis showed effect of group only at T@ ( CL : mean @ ; @ % CI @-@ @ ; HC : mean @ ; @ % CI @-@ @ ; control : mean @ ; @ % CI @-@ @ ; p = @ ) .


CL services can reduce state anxiety for patients presenting to a PED with heightened anxiety at baseline .


This reduction occurred immediately after CL intervention , but was not observed in patients exposed to HC or during physician examination .


Minimizing hemodynamic changes during the peri-intubation period is a concern for anesthesiologists .


We investigated the effect of lidocaine sprayed on the laryngoscope blade and trachea on hemodynamics during direct laryngoscopic intubation .


Seventy-two patients were randomly allocated to one of four groups : @ % lidocaine was sprayed either on the laryngoscope blade ( group L ) , on the trachea ( group V ) , or on the laryngoscope blade and the trachea ( group LV ) .


No lidocaine was used in group C. Anesthesia was induced in all patients with remifentanil ( effect site concentration : @ ng/ml ) and propofol ( effect site concentration @ g/ml ) continuous infusion using a target control infusion ( TCI ) device .


Mean arterial pressure ( MAP ) and heart rate ( HR ) were recorded during the peri-intubation period .


Changes in MAP and HR over time were markedly different among the four groups ( P < @ ) .


MAP at @ min post-intubation was significantly lower in groups L , V , and LV than in group C ( @ @ , @ @ , and @ @ vs. @ @ mmHg , P < @ ) .


Maximum MAP values were lower in groups L and LV than in group C ( P < @ ) .


HRs at @ , @ , and @ min post-intubation were lower in group LV than in group C ( @ @ vs. @ @ ; @ @ vs. @ @ ; @ @ vs. @ @ beats/min , P < @ , respectively ) .


Lidocaine sprayed on the laryngoscope blade and/or trachea reduced the hemodynamic response to laryngoscopic intubation during the post-intubation period following anesthetic induction with remifentanil and propofol using a TCI device .


To examine basic and everyday cognitive predictors of older adults ' self-reported instrumental activities of daily living ( IADL ) .


Basic and everyday cognitive predictors of self-reported IADL were examined in a sample of healthy , community-dwelling older adults ( n = @ ) assessed over @ years of measurement .


Multilevel longitudinal analyses revealed linear and quadratic change trends for self-reported IADL function , with steeper declines at higher ages .


Within-person , when participants exhibited lower cognitive performance , they also reported more IADL impairment .


Everyday cognition remained a significant unique predictor of self-reported IADL after controlling for attrition , resampling effects , temporal gradients , and baseline levels and changes in demographic , sensory , functional , and basic cognitive measures .


By itself , everyday cognition appears to be an important predictor of self-reported IADL , and maintains a unique predictive contribution after many covariates are controlled .


Future research should consider the inclusion of everyday cognitive measures in functional assessment batteries .


Post-operative nasogastric intubation after emergency laparotomy is a common practice in many centers , with the intent of hastening the return of bowel function , relieving gastrointestinal discomfort , reducing various post-operative complications and reducing hospital stay .


However , bowel rest and gastric decompression have been re-examined in the light of more recent data .


Many studies and meta-analyses over the last @ years have challenged the routine use of nasogastric tubes after laparotomy .


The objective of this study is to evaluate the need for routine nasogastric decompression after emergency laparotomy .


A prospective , randomized controlled trial was conducted for @ months ( May @ , @ to Apr @ , @ ) in the Department of Surgery , Tribhuvan University Teaching Hospital , after ethical approval .


Patients were enrolled as per criteria ( Box @ ) , and subsequently allocated by simple randomization into two groups : Group @ and Group @ .


Patients undergoing emergency laparotomy for perforation peritonitis , intestinal obstruction and abdominal trauma were randomized to two groups - with or without nasogastric tube after surgery .


Gastric upset , return of bowel function and postoperative complications were compared .


Total of @ patients met the inclusion criteria .


There was no statistically significant difference in the occurrence of gastric upset ( P : @ ) , wound complications ( P : @ ) , respiratory complications ( P : @ ) and anastomotic leak ( P : @ ) between two groups .


Bowel function returned in comparable times in both groups ( correlation coefficient : @ ; P : @ ) .


Nasogastric tube had to be reinserted in three patients in the group with nasogastric decompression postoperatively , and four in the group without ( P : @ ) .


Thus , routine nasogastric decompression neither prevented the development of gastrointestinal discomfort nor precluded the need for tube replacement once it was discontinued .


For every patient who required post-operative nasogastric decompression , at least @ patients were spared one .


Mean hospital stay was significantly more in the decompressed group ( @ days ; correlation coefficient : @ ; P < @ ) .


This study has shown that the prophylactic nasogastric decompression following emergency laparotomy is ineffective in achieving any of the intended goals .


Childhood obesity rates in the U.S. have reached epidemic proportions , and an urgent need remains to identify evidence-based strategies for prevention and treatment .


Multi-level , multi-component interventions are needed due to the multi-factorial nature of obesity , and its proven links to both the social and built environment .


However , there are huge gaps in the literature related to doing these kinds of interventions among low-income , urban , minority groups .


The B'More Healthy Communities for Kids ( BHCK ) intervention is a multi-level , multi-component intervention , targeting low-income African American youth ages @-@ and their families in Baltimore , Maryland .


This intervention prevents childhood obesity by working at multiple levels of the food and social environments to increase access to , demand for , and consumption of healthier foods .


BHCK works to create systems-level change by partnering with city policy-makers , multiple levels of the food environment ( wholesalers , corner stores , carryout restaurants ) , and the social environment ( peers and families ) .


In addition , extensive evaluation will be conducted at each level of the intervention to assess intervention effectiveness via both process and impact measures .


This project is novel in multiple ways , including : the inclusion of stakeholders at multiple levels ( policy , institutional , and at multiple levels of the food system ) ; that it uses novel computational modeling methodologies to engage policy makers and guide informed decisions of intervention effectiveness ; it emphasizes both the built environment ( intervening with food sources ) and the social environment ( intervening with families and peers ) .


The design of the intervention and the evaluation plan of the BHCK project are documented here .


The open Burch colposuspension , first described in @ had been widely employed for the surgical treatment of women with stress urinary incontinence ( SUI ) caused by urethral hypermobility .


We evaluated the long-term efficacy of laparoscopic Burch colposuspension ( LBC ) for SUI in women .


A randomized prospective trial was conducted from September @ to January @ .


The extraperitoneal laparoscopic Burch colposuspension was performed by an operator on @ women , mean age was @,@ @,@ years all of whom suffered from SUI or mixed urinary incontinence .


Patients completed a self-administered the Short Form-@ ( SF-@ ) , the Physical Component Summary ( PCS ) and Mental Component Summary ( MCS ) , the Short Urinary Distress Inventory ( SUDI ) and Short Incontinence Impact Questionnaire ( SIIQ ) .


at both baseline and follow up ( @ weeks , @ months , @ months postoperatively ) .


The Genito-Urinary Treatment Satisfaction Scale ( GUTSS ) was used to assess satisfaction with surgery .


After follow up was recorded an improvement of questionnaries scores .


The general health score is improved after surgery ( @,@ @ versus @,@ @ ) with p = @ .


The PCS baseline score is @ @ versus @ @ after treatment with p = @ , so there was a significant baseline to follow up improvement .


The MCS improved also , infact baseline score is @ @ versus @ @ with p = @ .


The SUDI baseline score is @ @ versus @ @ , while SIIQ score is @ @ versus @ @ with p < @ .


In both questionnaires there is an improvement .


Satisfaction with treatment outcomes from the GUTSS at @-month follow up is @ @ with p = @ .


The LBC has significant advantages , without any apparent compromise in short-term and long term outcomes .


The purpose of this study was to compare the effects of thoracic thrust manipulation vs thoracic non-thrust mobilization in patients with bilateral chronic mechanical neck pain on pressure pain sensitivity and neck pain intensity .


Fifty-two patients ( @ % were female ) were randomly assigned to a thoracic spine thrust manipulation group or of thoracic non-thrust mobilization group .


Pressure pain thresholds ( PPTs ) over C@-C@ zygapophyseal joint , second metacarpal , and tibialis anterior muscle and neck pain intensity ( @-point Numerical Pain Rate Scale ) were collected at baseline and @ minutes after the intervention by an assessor blinded to group allocation .


Mixed-model analyses of variance ( ANOVAs ) were used to examine the effects of the treatment on each outcome .


The primary analysis was the group * time interaction .


No significant interactions were found with the mixed-model ANOVAs for any PPT ( C@-C@ : P > @ ; second metacarpal : P > @ ; tibialis anterior : P > @ ) : both groups exhibited similar increases in PPT ( all , P < @ ) , but within-group and between-group effect sizes were small ( standardized mean score difference -LSB- SMD -RSB- < @ ) .


The ANOVA found that patients receiving thoracic spine thrust manipulation experienced a greater decrease in neck pain ( between-group mean difference : @ ; @ % confidence interval , @-@ @ ) than did those receiving thoracic spine non-thrust mobilization ( P < @ ) .


Within-group effect sizes were large for both groups ( SMD > @ ) , and between-group effect size was also large ( SMD = @ ) in favor of the manipulative group .


The results of this randomized clinical trial suggest that thoracic thrust manipulation and non-thrust mobilization induce similar changes in widespread PPT in individuals with mechanical neck pain ; however , the changes were clinically small .


We also found that thoracic thrust manipulation was more effective than thoracic non-thrust mobilization for decreasing intensity of neck pain for patients with bilateral chronic mechanical neck pain .


To determine whether a single session of motivational interviewing ( MI ) for feedback of a child 's overweight status promotes engagement in treatment following screening .


One thousand ninety-three children aged @-@ years were recruited through primary and secondary care to attend health screening , including assessment of parenting practices and motivation ( questionnaire ) .


Families with normal-weight children were informed about their child 's weight but had no further involvement .


Parents of overweight ( body mass index @th percentile ) children ( n = @ ) were randomised to receive weight feedback via MI or best practice care ( BPC ) using a traffic light concept to indicate degree of health risk .


Follow-up interviews were held @ weeks later to examine intervention uptake , changes to motivation and behaviour , and parental response to feedback .


Recruitment into the intervention was high ( @ % ) and not altered by feedback condition ( percentage difference @ ( @ % confidence interval -@ , @ ) .


High scores on the Health Care Climate Questionnaire ( rating of the interviewer ) indicated satisfaction with how the information was provided to parents .


No differences were observed in multiple indicators of harm .


However , self-determined motivation for healthy life-styles was significantly higher in the MI condition at follow-up ( @ : @ , @ ) , after only a single session of MI .


MI and BPC were both successful in encouraging parents to participate in a family-based intervention , with MI offering little significant benefit over BPC .


A traffic light approach to weight feedback is a suitable way of providing sensitive information to parents not expecting such news .


The most common form of maturity-onset diabetes of the young ( MODY ) , hepatocyte nuclear factor @ ( HNF@A diabetes : MODY@ ) is often treated with sulfonylureas that confer a high risk of hypoglycemia .


We evaluated treatment with GLP-@ receptor agonists ( GLP-@RAs ) in patients with HNF@A diabetes .


Sixteen patients with HNF@A diabetes ( @ women ; mean age @ years -LSB- range @-@ years -RSB- ; BMI @ @ kg/m ( @ ) -LSB- mean SEM -RSB- ; fasting plasma glucose -LSB- FPG -RSB- @ @ mmol/L ; HbA@c @ @ % -LSB- @ @ mmol/mol -RSB- ) received @ weeks of treatment with a GLP-@RA ( liraglutide ) and placebo ( tablets ) , as well as a sulfonylurea ( glimepiride ) and placebo ( injections ) , in randomized order , in a double-blind , crossover trial .


Glimepiride was up-titrated once weekly in a treat-to-target manner ; liraglutide was up-titrated once weekly to @ mg once daily .


At baseline and at the end of each treatment period a standardized liquid meal test was performed , including a @-min light bicycle test .


FPG decreased during the treatment periods ( -@ @ mmol/L liraglutide -LSB- P = @ -RSB- and -@ @ mmol/L glimepiride -LSB- P = @ -RSB- ) , with no difference between treatments ( P = @ ) .


Postprandial plasma glucose ( PG ) responses ( total area under the curve ) were lower with both glimepiride ( @,@ @ min mmol/L ) and liraglutide ( @,@ @ min mmol/L ) compared with baseline ( @,@ @ min mmol/L ; P < @ , glimepiride ; P = @ , liraglutide ) , with no difference between treatments ( P = @ ) .


Eighteen episodes of hypoglycemia ( PG @ mmol/L ) occurred during glimepiride treatment and one during liraglutide treatment .


Six weeks of treatment with glimepiride or liraglutide lowered FPG and postprandial glucose excursions in patients with HNF@A diabetes .


The glucose-lowering effect was greater with glimepiride at the expense of a higher risk of exclusively mild hypoglycemia .


Our aim was to assess the effects of the cholesteryl ester transfer protein ( CETP ) inhibitor anacetrapib and atorvastatin , both as monotherapy and in combination , on particle concentrations of low-density lipoproteins ( LDL ) , very low-density lipoproteins ( VLDL ) , and intermediate-density lipoproteins in dyslipidemic patients .


Although increases in high-density lipoproteins with CETP inhibition are well-documented , effects on atherogenic lipoprotein particle subclasses in dyslipidemic patients have not been extensively characterized .


Ion mobility was performed on stored plasma samples collected from patients before and after treatment with anacetrapib alone ( @ and @ mg/d ) or in combination with atorvastatin ( @ mg/d ) in a previously conducted @-week phase IIb study .


Anacetrapib produced significant placebo-adjusted reductions of total LDL particles and all subfractions except for increases in very small LDL @a and @b .


Atorvastatin reduced all LDL subfractions except LDL @b .


Results were generally additive for anacetrapib + atorvastatin .


For patients treated with anacetrapib , the placebo-adjusted reduction in LDL @a was attenuated and there was an increase in LDL @b and @a for those with low vs high triglyceride ( TG ) levels .


For the atorvastatin alone vs placebo treatment comparison , there were small reductions in LDL @a , @b , and @a for those with low vs high TG levels .


Anacetrapib and atorvastatin produced similar reductions from baseline in total LDL particles , but did not have comparable effects on all LDL particle subfractions , and neither drug reduced the smallest LDL @b particles .


The clinical significance of these changes and the differential effects on very small LDL @a in patients with higher vs lower TG remain to be determined ( clinicaltrials.gov , NCT@ ) .


Rituximab could be an effective treatment for childhood-onset , complicated , frequently relapsing nephrotic syndrome ( FRNS ) and steroid-dependent nephrotic syndrome ( SDNS ) .


We investigated the efficacy and safety of rituximab in patients with high disease activity .


We did a multicentre , double-blind , randomised , placebo-controlled trial at nine centres in Japan .


We screened patients aged @ years or older experiencing a relapse of FRNS or SDNS , which had originally been diagnosed as nephrotic syndrome when aged @-@ years .


Patients with complicated FRNS or SDNS who met all other criteria were eligible for inclusion after remission of the relapse at screening .


We used a computer-generated sequence to randomly assign patients ( @:@ ) to receive rituximab ( @ mg/m ( @ ) ) or placebo once weekly for @ weeks , with age , institution , treatment history , and the intervals between the previous three relapses as adjustment factors .


Patients , guardians , caregivers , physicians , and individuals assessing outcomes were masked to assignments .


All patients received standard steroid treatment for the relapse at screening and stopped taking immunosuppressive agents by @ days after randomisation .


Patients were followed up for @ year .


The primary endpoint was the relapse-free period .


Safety endpoints were frequency and severity of adverse events .


Patients who received their assigned intervention were included in analyses .


This trial is registered with the University Hospital Medical Information Network clinical trials registry , number UMIN@ .


Patients were centrally registered between Nov @ , @ , and May @ , @ .


Of @ patients who underwent randomisation , @ received the assigned intervention ( @ were given rituximab and @ placebo ) .


The median relapse-free period was significantly longer in the rituximab group ( @ days , @ % CI @-@ ) than in the placebo group ( @ days , @-@ ; hazard ratio : @ , @-@ ; p < @ ) .


Ten patients ( @ % ) in the rituximab group and six ( @ % ) in the placebo group had at least one serious adverse event ( p = @ ) .


Rituximab is an effective and safe treatment for childhood-onset , complicated FRNS and SDNS .


Increased physical activity is associated with decreased risk of several types of cancer , but underlying mechanisms are poorly understood .


Angiogenesis , in which new blood vessels are formed , is common to adipose tissue formation/remodeling and tumor vascularization .


We examined effects of a @-month @ minutes/day , @ days/week moderate-intensity aerobic exercise intervention on four serum markers of angiogenesis in @ sedentary , overweight , postmenopausal women , @ to @ years , randomized to intervention versus stretching control .


Circulating levels of positive regulators of angiogenesis -LSB- VEGF , osteopontin ( OPN ) , plasminogen activator inhibitor-@ ( PAI-@ ) -RSB- , and the negative regulator pigment epithelium-derived factor ( PEDF ) , were measured by immunoassay at baseline and @ months .


Changes were compared using generalized estimating equations , adjusting for baseline levels of analytes and body mass index ( BMI ) .


VEGF , OPN , or PAI-@ levels did not differ by intervention arm .


Participants randomized to exercise significantly reduced PEDF ( -@ % ) versus controls ( +@ % ; P = @ ) .


Reductions in fat mass were significantly associated with reductions in PAI-@ ( Ptrend = @ ; Ptrend = @ ) and PEDF ( Ptrend = @ ; Ptrend = @ ) compared with controls , or to those who gained any fat mass respectively .


There was a significant association between decreases in VO@max , and increased reductions in PEDF ( Ptrend = @ ) , compared with participants who increased their level of fitness .


Fat loss reduces circulating PAI-@ and PEDF .


Changes in VO@max are associated with alterations in PEDF , but these associations are complex .


Unexpected reductions in PEDF with decreasing fat mass , and with decreasing VO@max , warrant further study , including examining the effects of different types and intensities of exercise ; and role of dietary weight-loss with and without exercise .


Growth differentiation factor @ ( GDF-@ ) , high-sensitivity troponin , and N-terminal pro-brain natriuretic peptide levels are predictive of death and cardiovascular events in healthy elderly subjects , patients with acute coronary syndrome , and patients with heart failure .


High-sensitivity troponin I and N-terminal pro-brain natriuretic peptide are also prognostic in patients with atrial fibrillation .


We evaluated the prognostic value of GDF-@ alone and in addition to clinical characteristics and other biomarkers in patients with atrial fibrillation .


The Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation ( ARISTOTLE ) trial randomized @ patients with atrial fibrillation to apixaban or warfarin .


Biomarkers were measured at randomization in @ patients .


Efficacy and safety outcomes during @ years of follow-up were compared across quartiles of GDF-@ by use of Cox analyses adjusted for clinical characteristics , randomized treatment , and other biomarkers .


The GDF-@ level showed a median of @ ng/L ( interquartile range , @-@ ng/L ) .


Annual rates of stroke or systemic embolism ranged from @ % to @ % ( P < @ ) ; of major bleeding , from @ % to @ % ( P < @ ) ; and of mortality , from @ % to @ % ( P < @ ) in the lowest compared with the highest GDF-@ quartile .


The prognostic information provided by GDF-@ was independent of clinical characteristics and clinical risk scores .


Adjustment for the other cardiac biomarkers attenuated the prognostic value for stroke , whereas the prognostic value for mortality and major bleeding remained .


Apixaban consistently reduced stroke , mortality , and bleeding , regardless of GDF-@ levels .


GDF-@ is a risk factor for major bleeding , mortality , and stroke in atrial fibrillation .


The prognostic value for major bleeding and death remained even in the presence of N-terminal pro-brain natriuretic peptide and high-sensitivity troponin I.


To assess the effectiveness of behavioural management in the treatment of migraine among adult patients .


The randomised control trial was conducted from August @ to August @ at the Aga Khan University Hospital , Karachi , in which adult patients aged @-@ years were recruited with diagnosis of migraine from five outpatient sites .


The patients were randomised into @ equal groups .


The controls were given pharmacological treatment , while the cases were given a structured behavioural management and pharmacological treatment .


Primary outcome was the change in frequency of migraine attacks .


Secondary outcome included change in severity of migraine and effect on the quality of life .


SPSS @ was used for statistical analysis .


Of the @ subjects in the study , @ ( @ % ) were female .


A significant reduction in the average frequency of migraine attacks was observed from baseline up to @ weeks ( p < @ ) but no difference in the mean migraine attacks was observed in the two groups ( p < @ ) .


In the average score of severity of pain , significant reduction was observed for time ( p < @ ) as well as for the intervention status ( p < @ ) .


There was no significant difference ( p < @ ) between treatment type and duration of migraine , but a significantly better quality of life ( p < @ ) was observed in the trial group compared to the controls .


There was significant decrease in frequency , severity and duration of migraine attacks in the trial group compared to the control group .


The quality of life also showed improvement in the trial group .


Physical activity is one of the core components in cardiac rehabilitation and secondary prevention programs .


This study investigated the effect of an intervention based on the health action process approach ( HAPA ) together with family support in the maintenance of physical activity and exercise capacity in coronary heart disease after discharge from rehabilitation .


In this randomized controlled trial , @ patients with coronary heart disease were randomly assigned to control and intervention groups at the end of a rehabilitation program at Afshar Hospital , Yazd , Iran .


HAPA Constructs and family support using a self-reported questionnaire and maximal oxygen uptake through a treadmill exercise test were measured prior to and @ months after the intervention .


HAPA-based intervention together with family support increased scores of HAPA constructs and family support in the intervention group compared with the control group .


The results showed that physical activity and exercise capacity in the intervention group was significantly higher than the control group after the intervention .


HAPA-based intervention together with family support can be a useful tool for maintenance of physical activity and exercise capacity in coronary heart disease .


To observe the physiological and psychological effects of Chinese traditional healthcare exercises ( CTHE ) on the adolescents .


A total of @ healthy students of junior school were recruited and randomly divided into the test group ( @ cases ) and the control group ( @ cases ) .


The subjects in the test group practiced CTHE , while those in the control group did `` the @th radio calisthenics '' , an official recommended calisthenics for promoting healthcare in China , @ times a week , and @ weeks practicing overall .


The general body function examination and the meridian energy detection system were used to determine the effects of the two groups .


( @ ) After exercise , the chest circumference and heart rate were increased significantly ( P < @ ) , and both the systolic pressure ( SP ) and diastolic pressure ( DP ) were decreased significantly ( P < @ ) , while the weight had no significant change ( P > @ ) in the test group .


In the control group , the chest circumference , the SP and DP had no significant improvement ( P > @ ) , while the heart rate was significantly increased and the weight was significantly decreased ( P < @ ) .


( @ ) The test group achieved significant positive changes in the performance status , state of mind and fatigue index ( P < @ or P < @ ) , while the control group only achieved a significant positive change in performance status ( P < @ ) , and a negative significant decrease in the autonomic nerve function ( P < @ ) .


Junior school students would get physiological and psychological benefit from practicing CTHE , and which is suitable for them to practice .


The relationships between cerebrovascular lesions visible on imaging and cognition are complex .


We explored the possibility that the cerebral cortical volume mediated these relationships .


Total of @ nondemented participants ( @ % women ; @ % African-American ; mean age , @ years ) in the Atherosclerosis Risk in Communities ( ARIC ) study underwent cognitive assessments , risk factor assessments , and quantitative MRI for white matter hyperintensities ( WMH ) and infarcts .


The Freesurfer imaging analysis pipeline was used to determine regional cerebral volumes .


We examined the associations of cognitive domain outcomes with cerebral volumes ( hippocampus and separate groups of posterior and frontal cortical regions of interest ) and cerebrovascular imaging features ( presence of large or small cortical/subcortical infarcts and WMH volume ) .


We performed mediation pathway analyses to assess the hypothesis that hippocampal and cortical volumes mediated the associations between cerebrovascular imaging features and cognition .


In unmediated analyses , WMH and infarcts were both associated with worse psychomotor speed/executive function .


In mediation analyses , WMH and infarct associations on psychomotor speed/executive function were significantly attenuated , but not abolished , by the inclusion of the posterior cortical regions of interest volume in the models , and the infarcts on psychomotor speed/executive function association were attenuated , but not abolished , by inclusion of the frontal cortical regions of interest volume .


Both WMH and infarcts were associated with cortical volume , and both lesions were also associated with cognitive performance , implying shared pathophysiological mechanisms .


Although cross-sectional , our findings suggest that WMH and infarcts could be proxies for clinically covert processes that directly damage cortical regions .


Microinfarcts are @ candidate for such a clinically covert process .


Although white matter hyperintensities ( WMHs ) are associated with the risk for Alzheimer disease , it is unknown whether they represent an independent source of impairment or interact with known markers of disease .


To examine the degree to which WMHs predict aggressive cognitive decline among individuals with mild cognitive impairment , either independently or by modifying the effects of entorhinal cortex volume ( ECV ) , a marker of Alzheimer disease-related neurodegeneration .


The Alzheimer 's Disease Neuroimaging Initiative is a longitudinal study with @-month follow-up visits .


Three hundred thirty-two participants ( mean -LSB- SD -RSB- age , @ -LSB- @ -RSB- years ; @ women ) of a total of @ participants diagnosed as having mild cognitive impairment were included .


Participants were excluded if they did not have longitudinal data , apolipoprotein E genotype data , or had evidence of supratentorial infarct .


A decline in Mini-Mental State Examination score of @ points over @ months or @ points over @ year between consecutive visits was defined as aggressive decline .


White matter hyperintensity volume and ECV were entered as predictors in Cox proportional hazards models and Wilcoxon-Breslow tests to examine their impact on this outcome , adjusting for sex , age , education , and apolipoprotein E status .


Greater WMH volume at baseline , apolipoprotein E @ status , and smaller ECV at baseline were associated with an increased risk for aggressive decline ( hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @-@ @ ; P = @ for WMH volume ; HR , @ ; @ % CI , @-@ @ ; P = @ for apolipoprotein E @ status ; HR , @ ; @ % CI , @-@ @ ; P < @ for ECV ) .


White matter hyperintensity volume modified the effect of ECV on aggressive decline risk : individuals with high ECV and low WMH were at particularly low likelihood of decline ( @ = @ , P = @ ) .


Participants with Mini-Mental State Examination scores that declined by @ or more points over @ months or @ or more points over @ months were more likely to have converted to Alzheimer disease by the end of the follow-up period ( @ = @ , P < @ ) .


White matter hyperintensity burden and ECV predict rapid cognitive decline among individuals with mild cognitive impairment both additively and multiplicatively .


There is a need for an adjuvant agent of caudal block that prolongs its duration and improves the analgesic efficacy to fasten functional recovery .


Magnesium is an N-methyl-D-aspartate receptor antagonist that functions as an analgesic .


This study was aimed to evaluate whether magnesium as an adjuvant for caudal block in children can improve postoperative analgesia and functional recovery .


Eighty children , @-@ years of age , undergoing inguinal herniorrhaphy , were included in this prospective , randomized , double-blinded study .


For caudal block , Group R received ropivacaine @ mgml ( -@ ) , @ mlkg ( -@ ) and Group RM received the same dose of ropivacaine mixed with @ mg of magnesium .


The Parents ' Postoperative Pain Measure ( PPPM ) score , analgesic consumption , functional recovery , and adverse effects were evaluated at @ , @ , @ , and @ h after surgery , as well as daily thereafter until the child showed full functional recovery .


The PPPM score after hospital discharge was significantly lower for Group RM than for Group R at all times ( P < @ ) .


Children in Group RM required less fentanyl for rescue analgesia in the recovery area ( @ % vs @ % , P = @ ) and less oral analgesics after discharge ( @ % vs @ % , P = @ ) .


The time to return of normal functional activity was shorter in Group RM ( P < @ ) .


The incidence of adverse effects did not differ between groups .


As an adjuvant for caudal analgesia , @ mg magnesium provided superior quality of analgesia and faster return of normal functional activity than local anesthetic alone in children .


Cytology is a widely used method of triaging women who test positive for human papillomavirus ( HPV ) .


However , self-sampled specimens , which can substantially increase participation in screening programmes , are not suitable for accurate cytological assessment .


We investigated whether direct DNA methylation-based molecular triage on self-sampled cervicovaginal specimens was non-inferior to cytology triage on additional physician-collected cervical samples in the detection of cervical intraepithelial neoplasia grade @ ( CIN@ ) or worse in women who did not attend cervical screening programmes .


In this randomised controlled non-inferiority trial , we invited women ( aged @-@ years ) registered as non-attendees of cervical screening in the Netherlands in @ to submit a self-collected cervicovaginal sample for HPV testing .


Using a computer-generated sequence , we randomly allocated women who tested positive for high-risk hrHPV on a self-sample to either triage by cytology on an additional physician-taken smear or direct triage on the self-sample by methylation analysis of MAL and miR-@-@ genes ( @:@ ; stratified by age and region , with block sizes by age group ) .


Triage-positive women in either group were referred for colposcopy .


The primary endpoint was detection of CIN@ or worse , analysed by intention to treat .


The non-inferiority margin was @ .


This study is registered in the Primary Trial Register of the Netherlands , number NTR@ .


We invited @,@ women to participate , @,@ of whom returned self-sampled material ; @ samples tested positive for high-risk HPV .


Between Nov @ , @ , and Dec @ , @ , after exclusion of women who were ineligible , we enrolled and randomly allocated @ women to methylation triage and @ to cytology triage .


The detection of CIN@ or worse with methylation triage was non-inferior to that with cytology triage ( @ -LSB- @ % -RSB- of @ women vs @ -LSB- @ % -RSB- of @ women ; relative risk @ , @ % CI @-@ ) .


Referral for colposcopy was more common in the molecular group ( @ -LSB- @ % -RSB- women ) than in the cytology group ( @ -LSB- @ % -RSB- women ; p < @ ) .


Mean time to CIN@ or worse diagnosis was shorter in the molecular triage group ( @ days , range @-@ ) than in the cytology triage group ( @ days , @-@ ; p = @ ) .


DNA methylation analysis of MAL and miR-@-@ genes on HPV-test-positive self-samples is non-inferior to cytology triage in the detection of CIN@ or worse , opening the way to full molecular screening .


To evaluate the effect of artificial demineralization upon color change of dentin in contact with dental amalgam .


Sound human molars ( n = @ ) were embedded in resin and coronal enamel was removed .


Dentin was exposed to artificial caries gel ( pH @ ) at @ degrees C for @ weeks ( n = @ ) .


Non-demineralized teeth served as controls ( n = the @ ) .


A dispersive high-Cu amalgam or conventional low-Cu amalgam was condensed onto dentin surfaces of all groups .


After @ weeks storage in saline , amalgam was removed and teeth were cut into three slices .


Surfaces were inspected under optical microscopy and photographed .


Penetration of black pigments was observed in dentin underneath both high-Cu and low-Cu amalgams in demineralized specimens .


Black deposits were unevenly distributed and observed predominantly in dentin near to pulp horns .


Discoloration was not limited to outer demineralized dentin but extended beyond this zone .


Evenly distributed bluish-green discoloration was observed underneath all high-Cu amalgam specimens independent of demineralization .


Evaluation of analgesia and antinociception during anaesthesia is still a challenging issue and routinely based on indirect and non-specific signs such as movement , tachycardia , or lacrimation .


Recently , the surgical pleth index ( SPI ) derived by finger plethysmography was introduced to detect nociceptive stimulation during anaesthesia .


While SPI guidance reduced the number of unwanted events during total i.v. anaesthesia ( TIVA ) , the impact of SPI during volatile-based anaesthesia with intermittent opioid administration has not yet been elucidated .


Ninety-four patients were randomized into either SPI-guided analgesia or standard practice ( Control ) .


In both groups , anaesthesia was maintained with sevoflurane to keep bispectral index values between @ and @ .


In the SPI group , patients received a sufentanil bolus ( @ g ) whenever SPI value increased above @ , whereas in the control group , sufentanil was administered according to standard clinical practice .


The number of unwanted somatic events , haemodynamics , sufentanil consumption , and recovery times were recorded .


The incidence of intraoperative unwanted somatic events was comparable between the groups ( P = @ ) .


No significant differences with respect to hypotensive or hypertensive events were found .


The mean ( @ % confidence interval ) sufentanil consumption was non-significantly ( P = @ ) reduced in the SPI group , @ ( @-@ @ ) vs @ ( @-@ @ ) g min ( -@ ) .


Recovery times were comparable between the groups .


Sufentanil administration guided by SPI during sevoflurane anaesthesia is clinically feasible .


In contrast to TIVA , it did not improve anaesthesia conduct with respect to unwanted somatic events , haemodynamic stability , sufentanil consumption , emergence time , or post-anaesthesia care unit care .


Therefore , we conclude that anaesthesia regimen has an impact on beneficial effects by SPI guidance .


Clinical trial registration NCT@ .


( Registered at Clinicaltrials.gov . )


Equol is produced by the intestinal bacteria from isoflavone daidzein .


Studies have reported the health benefits of soy can only present or more pronounced in equol producers .


This @-month randomized controlled trial examined the effect of whole soy ( soy flour ) and purified daidzein on cardiovascular biomarkers and carotid intima-media thickness ( CIMT ) in prehypertensive postmenopausal women who were equol producers .


Two hundred seventy eligible women were randomized to either one of the three treatments : @ g soy flour ( whole soy group ) , @ g low-fat milk powder + @mg daidzein ( daidzein group ) , or @ g low-fat milk powder ( placebo group ) daily each for @ months .


Fasting venous samples were obtained at baseline and end of trial for testing glucose , lipids , high sensitivity C-reactive protein ( hs-CRP ) , and free fatty acid .


Changes in common CIMT were also assessed .


Serum LDL-C decreased by @ % ( @ % CI : -@ -@ % ) and @ % ( @ % CI : -@ % ) , and serum hs-CRP decreased by @ ( @ % CI : -@ -@ ) and @ ( @ % CI : -@ ) in the whole soy group compared with daidzein and milk placebo groups , respectively .


No significant change in CIMT was found .


Whole soy , but not purified daidzein , had a beneficial effect on reduction of LDL-C and hs-CRP among prehypertensive equol-producing postmenopausal women .


To investigate the effectiveness of an intensive nursing care electronic followup system for cardiovascular risk management after percutaneous coronary intervention ( PCI ) .


In total , @ subjects who underwent PCI in a single hospital in Beijing between January @ and January @ were enrolled .


All subjects were randomized into the control and intensive nursing care groups ( n = @ each group ) .


Both groups received standard secondary prevention according to guidelines .


The control group received regular followup while the intensive nursing care group was closely monitored and followed by specific nursing staff with the electronic followup system .


In total , @ subjects were followed up for @ year .


Compared with subjects in the control group , those in the intensive group had decreased levels of total cholesterol ( @ @ vs @ @ ; P < @ ) , systolic blood pressure ( @ @ vs @ @ mm Hg ; P < @ ) , low-density lipoprotein cholesterol ( LDL-C ) ( @ @ vs @ @ ; P < @ ) , and body mass index ( @ @ vs @ @ ; P < @ ) ; a higher percentage with target LDL-C < @ mmol/L ( @ % vs @ % ; P < @ ) ; increased use of medication including aspirin ( @ % vs @ % ; P < @ ) , clopidogrel ( @ % vs @ % ; P < @ ) , statins ( @ % vs @ % ; P < @ ) , - blockers ( @ % vs @ % ; P < @ ) , and angiotensin-converting enzyme inhibitors ( @ % vs @ % ; P < @ ) ; and better dietary control and physical exercise ( @ % vs @ % , P < @ ; @ % vs @ % , P < @ ) .


Intensive nursing care by the electronic followup system may lead to an improvement in quality of secondary prevention after PCI , including risk factor control , the use of medication , and self-management abilities .


This study evaluates the efficacy of integrating PTSD treatment into Dialectical Behavior Therapy ( DBT ) for women with borderline personality disorder , PTSD , and intentional self-injury .


Participants were randomized to DBT ( n = @ ) or DBT with the DBT Prolonged Exposure ( DBT PE ) protocol ( n = @ ) and assessed at @-month intervals during the treatment year and @-months post-treatment .


Treatment expectancies , satisfaction , and completion did not differ by condition .


In DBT+DBT PE , the DBT PE protocol was feasible to implement for a majority of treatment completers .


Compared to DBT , DBT+DBT PE led to larger and more stable improvements in PTSD and doubled the remission rate among treatment completers ( @ % vs. @ % ) .


Patients who completed the DBT PE protocol were @ times less likely to attempt suicide and @ times less likely to self-injure than those in DBT .


Among treatment completers , moderate to large effect sizes favored DBT+DBT PE for dissociation , trauma-related guilt cognitions , shame , anxiety , depression , and global functioning .


DBT with the DBT PE protocol is feasible , acceptable , and safe to administer , and may lead to larger improvements in PTSD , intentional self-injury , and other outcomes than DBT alone .


The findings require replication in a larger sample .


Recent studies of inhaled tobramycin in subjects with cystic fibrosis ( CF ) find less clinical improvement than previously observed .


Nonhuman data suggest that in some strains of Pseudomonas aeruginosa , azithromycin can antagonize tobramycin .


We tested the hypothesis that concomitant azithromycin use correlates with less improvement in key outcome measures in subjects receiving inhaled tobramycin while not affecting those receiving a comparative , nonaminoglycoside inhaled antibiotic .


We studied a cohort of @ subjects with CF enrolled in a recent clinical trial comparing inhaled tobramycin with aztreonam lysine .


We performed a secondary analysis to examine key clinical and microbiologic outcomes based on concomitant , chronic azithromycin use at enrollment .


The cohort randomized to inhaled tobramycin and reporting azithromycin use showed a significant decrease in the percent predicted FEV@ after one and three courses of inhaled tobramycin when compared with those not reporting azithromycin use ( @ d : -@ vs. @ % , P < @ ; @ d : -@ vs. @ % , P < @ ) .


Combined azithromycin and inhaled tobramycin use was also associated with earlier need for additional antibiotics , lesser improvement in disease-related quality of life , and a trend toward less reduction in sputum P. aeruginosa density .


Subjects randomized to inhaled aztreonam lysine had significantly greater improvement in these outcome measures , which were unaffected by concomitant azithromycin use .


Outcomes in those not using azithromycin who received inhaled tobramycin were not significantly different from subjects receiving aztreonam lysine .


Azithromycin also antagonized tobramycin but not aztreonam lysine in @ % of P. aeruginosa clinical isolates tested in vitro .


Oral azithromycin may antagonize the therapeutic benefits of inhaled tobramycin in subjects with CF with P. aeruginosa airway infection .


To evaluate the efficacy and safety of the @-adrenoceptor agonist mirabegron , in a Japanese population with overactive bladder ( OAB ) .


This randomised , double-blind , placebo-controlled phase III study enrolled adult patients experiencing OAB symptoms for @ weeks .


Patients with @ micturitions/@h and @ urgency episode/@h or @ urgency incontinence episode/@h were randomised to once-daily placebo , mirabegron @mg or tolterodine @mg ( as an active comparator , without testing for non-inferiority of efficacy and safety ) for @ weeks .


The primary endpoint was the change in the mean number of micturitions/@h from baseline to final assessment .


Secondary endpoints included micturition variables related to urgency and/or incontinence and quality-of-life domain scores on the King 's Health Questionnaire .


Safety assessments included adverse events ( AEs ) , post-void residual urine volume , laboratory variables , vital signs and @-lead electrocardiogram .


A total of @ patients were randomised to receive placebo ( n = @ ) , mirabegron @mg ( n = @ ) or tolterodine @mg ( n = @ ) .


Demographic and baseline characteristics were similar among the treatment groups .


At final assessment , mirabegron was significantly superior to placebo in terms of mean -LSB- sd -RSB- change from baseline in number of micturitions/@h ( -@ -LSB- @ -RSB- vs -@ -LSB- @ -RSB- ; P < @ ) and mean -LSB- sd -RSB- change from baseline in number of urgency episodes/@h ( -@ -LSB- @ -RSB- vs -@ -LSB- @ -RSB- ; P = @ ) , incontinence episodes/@h ( -@ -LSB- @ -RSB- vs -@ -LSB- @ -RSB- ; P = @ ) , urgency incontinence episodes/@h ( -@ -LSB- @ -RSB- vs -@ -LSB- @ -RSB- ; P = @ ) , and volume voided/micturition ( @ -LSB- @ -RSB- vs @ -LSB- @ -RSB- mL ; P < @ ) .


The incidence of AEs in the mirabegron group was similar to that in the placebo group .


Most AEs were mild and none were severe .


Mirabegron @mg once daily is an effective treatment for OAB symptoms , with a low occurrence of side effects in a Japanese population .


Acute hemorheological responses to different types of aerobic exercises have never been compared in a single study in healthy people .


We aimed to compare acute effects of high intensity intermittent exercise ( HIIE ) and moderate intensity continuous exercise ( MICE ) on hemorheological parameters , in healthy young subjects .


A total of @ sedentary young adults ( @ males , @ females ) with a mean age of @ @ years were randomly assigned to HIIE , MICE or non-exercise groups .


MICE exercised at the power corresponding to @ % of heart rate reserve ( HRR ) continuously for @ min .


HIIE exercised at the power corresponding to @ % of HRR for @ s followed by @ s rest for @ min .


The non-exercise group rested .


Blood samples were collected before and after exercise and studied for blood count , whole blood viscosity ( WBV ) , plasma viscosity ( PV ) and red blood cell ( RBC ) elongation at nine different shear stresses .


WBV , PV , RBC elongation of MICE and HIIE groups were not found to be statistically different from each other or from the non-exercise group .


Compared to the non-exercise group , there was a significant increase in white blood cell ( WBC ) and RBC counts in the MICE group .


Different types of aerobic exercises , namely MICE , HIIE are not different from each other in terms of hemorheological parameters immediately after exercise .


To determine the effectiveness of a peer-led self-management programme for people with schizophrenia in reducing psychotic symptom severity , hospital readmission and psychiatric consultation and in enhancing cognition , empowerment , functioning level , medication adherence , perceived recovery , quality of life and social support .


Several self-management programmes have been developed to empower patients with severe mental illness in achieving recovery .


Research suggests that peer-led self-management programmes have positive effects on patient recovery .


However , the existing evidence is inconclusive , due to a lack of credible evidence and long-term follow-up evaluations .


A stratified randomized controlled trial will be conducted at six community mental health rehabilitation centres


A sample of @ adults with schizophrenia will be recruited .


A peer-led self-management programme , comprising six @-hour sessions , will be implemented in the intervention group and a standard rehabilitation programme in the control group .


Outcomes will be measured at baseline , postintervention and at the @ - and @-month follow-ups .


The measures will include cognition , empowerment , functioning level , medication adherence , perceived recovery , quality of life , social support , symptom severity , hospital readmission and psychiatric consultation .


A mixed effects model will be used to analyse the results .


Semi-structured interviews will be conducted to explore the peer-trainers ' and participants ' perspectives on the programme .


Research Ethics Committee approval was obtained in December @ and funding was obtained in January @ .


This study will provide evidence on the effectiveness of a peer-led self-management programme for patient recovery .


It will identify a clinically useful and potentially effective intervention that incorporates empowerment concept .


The optimum dose of key antiretroviral drugs is often overlooked during product development .


The ENCORE@ study compared the efficacy and safety of reduced dose efavirenz with standard dose efavirenz in combination with tenofovir and emtricitabine as first-line treatment for HIV infection .


An effective and safe reduced dose could yield meaningful cost savings .


ENCORE@ is a continuing non-inferiority trial in HIV-@-infected antiretroviral-naive adults in @ clinical sites in @ countries .


Participants ( plasma HIV-RNA > @ log@ copies per mL , CD@ T-cell count @-@ cells per L ) were randomly assigned by a computer-generated sequence with a blocking factor of four ( stratified by clinical site and by screening viral load ) to receive tenofovir plus emtricitabine with either a reduced daily dose ( @ mg ) or a standard dose ( @ mg ) of efavirenz .


Participants , physicians , and all other trial staff were masked to treatment group .


The primary endpoint was the difference in proportions of participants with plasma HIV-RNA of less than @ copies per mL at @ weeks .


Treatment groups were regarded as non-inferior if the lower limit of the @ % CI for the difference in viral load was less than -@ % by modified intention-to-treat analysis .


Adverse events were summarised by treatment .


This trial is registered with ClinicalTrials.gov , number NCT@ .


The modified intention-to-treat analysis consisted of @ patients ( efavirenz @ = @ ; efavirenz @ = @ ) .


@ % were women ; @ % were African , @ % were Asian , and @ % were white .


The mean baseline CD@ cell count was @ cells per L ( SD @ ) and median plasma HIV-RNA was @ log@ copies per mL ( IQR @ ) .


The proportion of participants with a viral load below @ copies per mL at week @ was @ % for efavirenz @ mg and @ % for @ mg ( difference @ % , @ % CI -@ to @ ) .


CD@ T-cell counts at week @ were significantly higher for the @ mg group than for the @ mg group ( mean difference @ cells per L , @ % CI @-@ ; p = @ ) .


We recorded no difference in grade or number of patients reporting adverse events ( efavirenz @ = @ % , efavirenz @ = @ % ; difference @ % , @ % CI -@ to @ ; p = @ ) .


Study drug-related adverse events were significantly more frequent in the @ mg group than in the @ mg group ( @ % -LSB- @ -RSB- vs @ -LSB- @ -RSB- ) , difference -@ % , @ % CI -@ to -@ ; p = @ ) and significantly fewer patients with these events stopped treatment ( @ mg = @ -LSB- @ % -RSB- , @ mg = @ -LSB- @ % -RSB- , difference -@ % , @ % CI -@ to -@ ; p = @ ) .


Our findings suggest that a reduced dose of @ mg efavirenz is non-inferior to the standard dose of @ mg , when combined with tenofovir and emtricitabine during @ weeks in ART-naive adults with HIV-@ infection .


Adverse events related to the study drug were more frequent with @ mg efavirenz than with @ mg .


Lower dose efavirenz should be recommended as part of routine care .


The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy ( ELA ) with adjunctive percutaneous transluminal angioplasty ( PTA ) versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis ( ISR ) .


Femoropopliteal stenting has shown superiority to PTA for lifestyle-limiting claudication and critical limb ischemia , although treating post-stenting artery reobstruction , or ISR , remains challenging .


The multicenter , prospective , randomized , controlled EXCITE ISR ( EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis ) trial was conducted across @ U.S. centers .


Patients with Rutherford Class @ to @ and lesions of target lesion length @ cm , vessel diameter @ to @ mm were enrolled and randomly divided into ELA + PTA and PTA groups by a @:@ ratio .


The primary efficacy endpoint was target lesion revascularization ( TLR ) at @-month follow up .


The primary safety endpoint was major adverse event ( death , amputation , or TLR ) at @ days post-procedure .


Study enrollment was stopped at @ patients due to early efficacy demonstrated at a prospectively-specified interim analysis .


A total of @ ELA + PTA subjects ( @ % male ; mean age @ @ years ) and @ PTA patients ( @ % male ; mean age @ @ years ) were enrolled .


Mean lesion length was @ @ cm versus @ @ cm , and @ % versus @ % of patients exhibited total occlusion .


ELA + PTA subjects demonstrated superior procedural success ( @ % vs. @ % ; p = @ ) with significantly fewer procedural complications .


ELA + PTA and PTA subject @-month freedom from TLR was @ % versus @ % ( p < @ ) , and @-day major adverse event rates were @ % versus @ % ( p < @ ) , respectively .


ELA + PTA was associated with a @ % reduction in TLR ( hazard ratio : @ ; @ % confidence interval : @ to @ ) .


The EXCITE ISR trial is the first large , prospective , randomized study to demonstrate superiority of ELA + PTA versus PTA alone for treating femoropopliteal ISR .


( Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis -LSB- EXCITE ISR -RSB- ; NCT@ ) .


In patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion , intraarterial treatment is highly effective for emergency revascularization .


However , proof of a beneficial effect on functional outcome is lacking .


We randomly assigned eligible patients to either intraarterial treatment plus usual care or usual care alone .


Eligible patients had a proximal arterial occlusion in the anterior cerebral circulation that was confirmed on vessel imaging and that could be treated intraarterially within @ hours after symptom onset .


The primary outcome was the modified Rankin scale score at @ days ; this categorical scale measures functional outcome , with scores ranging from @ ( no symptoms ) to @ ( death ) .


The treatment effect was estimated with ordinal logistic regression as a common odds ratio , adjusted for prespecified prognostic factors .


The adjusted common odds ratio measured the likelihood that intraarterial treatment would lead to lower modified Rankin scores , as compared with usual care alone ( shift analysis ) .


We enrolled @ patients at @ medical centers in The Netherlands ( @ assigned to intraarterial treatment and @ to usual care alone ) .


The mean age was @ years ( range , @ to @ ) , and @ patients ( @ % ) were treated with intravenous alteplase before randomization .


Retrievable stents were used in @ of the @ patients ( @ % ) assigned to intraarterial treatment .


The adjusted common odds ratio was @ ( @ % confidence interval -LSB- CI -RSB- , @ to @ ) .


There was an absolute difference of @ percentage points ( @ % CI , @ to @ ) in the rate of functional independence ( modified Rankin score , @ to @ ) in favor of the intervention ( @ % vs. @ % ) .


There were no significant differences in mortality or the occurrence of symptomatic intracerebral hemorrhage .


In patients with acute ischemic stroke caused by a proximal intracranial occlusion of the anterior circulation , intraarterial treatment administered within @ hours after stroke onset was effective and safe .


( Funded by the Dutch Heart Foundation and others ; MR CLEAN Netherlands Trial Registry number , NTR@ , and Current Controlled Trials number , ISRCTN@ . )


To test the efficacy of self-regulation ( SR ) for promoting task performance and motor and cognitive functions .


Pilot randomized controlled trial .


Rehabilitation unit .


Inpatients with acute poststroke ( N = @ ) after a cerebral infarction aged @ years .


Patients were randomly assigned to the SR ( n = @ ) or functional rehabilitation ( control ; n = @ ) intervention .


The SR intervention consisted of @ week of therapist-supervised practices of daily tasks using SR of one 's own performance ( five @-h sessions ) .


Patients in the control intervention practiced the same daily tasks with a therapist 's demonstration and guidance .


Performance of tasks , including household and monetary transaction tasks ; FIM ; Fugl-Meyer Assessment ( FMA ) ; and Color Trails Test ( CTT ) .


The SR group showed significant improvement in all tasks ( median difference , @-@ ; effect size -LSB- r -RSB- = @ -@ ) versus none ( median difference , @-@ @ ) in the control group .


Results of the FIM ( P < @ , r = @ in the motor subscale ; P < @ , r = @ in the cognitive subscale ) , FMA ( P < @ , r = @ for upper extremity motor function and r = @ for lower extremity motor function ) , and CTT ( P = @ , r = @ ) of the SR group improved .


The SR group outperformed their control counterparts in @ of the @ tasks ( median difference , @ ; r = @ -@ ) and in the FIM motor subscale ( P = @ , r = @ ) , but not in the cognitive subscale and motor and cognitive functions .


SR appears useful for improving task performance that demands both motor and cognitive abilities by promoting information processing and active learning .


Tofacitinib is a novel , oral Janus kinase inhibitor currently under investigation for plaque psoriasis .


This exploratory analysis of a Phase IIb , @-week , dose-ranging study ( clinicaltrials.gov identifier : NCT@ ) evaluated tofacitinib efficacy in four body regions of patients with moderate-to-severe chronic plaque psoriasis .


Patients ( n = @ ) were randomized to tofacitinib @ , @ , or @ mg , or placebo , twice daily ( BID ) .


Psoriasis Area and Severity Index ( PASI ) score , body surface area values and change from baseline to week @ were measured according to body region ( head/neck , upper limbs , trunk and lower limbs ) .


Change in Target Plaque Severity Score ( TPSS ) from baseline to week @ was measured according to typically responsive as well as non-responsive treatment areas .


At week @ , mean improvements in PASI and body surface area values were significantly greater with tofacitinib doses vs placebo across all four body regions measured ( P < @ ) .


TPSS in responsive areas decreased ( improved ) with tofacitinib @ , @ , and @ mg BID vs placebo : -@ , -@ and -@ , vs -@ , respectively ( P < @ ) .


In non-responsive areas , TPSS decreased with tofacitinib @ , @ , and @ mg BID vs placebo : -@ , -@ and -@ , vs -@ , respectively ( P < @ ) .


Short-term ( @-week ) treatment with oral tofacitinib produced clinical improvement across all body regions assessed in patients with moderate-to-severe plaque psoriasis , including areas typically non-responsive to treatment .


Exercise training improves physical fitness , insulin resistance , and endothelial function in type @ diabetes .


Hypoxia may further optimize these beneficial effects .


The aim of this study was to compare the effects of hypoxic versus normoxic exercise training on physical fitness , endothelial function , and insulin resistance in type @ diabetes .


Peak oxygen consumption , flow mediated dilation ( endothelial function ) , and glucose homeostasis were assessed in @ patients ( @ years ) before and after an @-week intervention .


Subjects were randomly allocated to normoxic ( @ % O@ , n = @ ) or hypoxic ( @ % O@ , n = @ ) exercise training .


Endothelium-independent dilation was examined using sublingual administration of glyceryl trinitrate , and used to calculate the ratio between endothelium-dependent and - independent dilation .


Exercise training improved physical fitness and brachial artery ratio between endothelium-dependent and - independent dilation ( both p < @ ) , whilst these exercise training-induced changes were similar in both groups ( interaction-effects p > @ ) .


Exercise training did not significantly change brachial artery flow-mediated dilation or glyceryl trinitrate-response , superficial femoral artery flow-mediated dilation , or glucose homeostasis , whilst hypoxia did not alter the impact of exercise training .


Contrary to our hypothesis , hypoxia does not potentiate the effect of exercise training on physical fitness , vascular function , or glucose homeostasis in type @ diabetes .


The effect of neighborhood and healthcare access factors on cancer outcomes among patients enrolled in navigator programs is not clearly understood .


This study assessed associations between : ( i ) neighborhood factors and diagnostic time to resolution ( TTR ) and ( ii ) geographic access and TTR following an abnormal breast or cervical cancer screening test among women participating in the Ohio Patient Navigator Research Program ( OPNRP ) .


Patient ( demographic , socioeconomic status , home-to-clinic distance ) and neighborhood ( deprivation , racial segregation ) characteristics of @ women living in one of @ census tracts ( CT ) in greater Columbus , Ohio were examined .


Randomization to receive navigation occurred at the clinic level .


Multilevel Cox regression and spatial analysis were used to estimate effects of various factors on TTR and assess model assumptions , respectively .


TTR increased as neighborhood deprivation increased .


After adjustment for age , friend social support , education , and healthcare status , the TTR among women living in a neighborhood with a moderate median household income ( between $ @,@ and $ @,@ ) was shorter compared with women living in low median household income neighborhoods ( < $ @,@ ; P < @ ) .


There is little evidence that unmeasured confounders are geographically patterned .


Increased neighborhood socioeconomic deprivation was associated with longer TTR following an abnormal breast or cervical cancer screening test .


These results highlight the need for addressing patient - and neighborhood-level factors to reduce cancer disparities among underserved populations .


Hypoxemia is a surrogate marker for periprocedural endoscopic complications .


There are no data comparing the safety of propofol sedation with another sedative regimen in medical thoracoscopy .


To evaluate whether sedation with propofol is as safe and effective as sedation with midazolam .


Ninety consecutive patients undergoing medical thoracoscopy were randomly allocated to receive either intravenous propofol or midazolam .


Predefined periprocedural complications included hypoxemia , hypotension , bleeding , need for airway insertion , mechanical ventilation , intensive care unit transfer and death .


The primary endpoint was the mean lowest oxygen saturation during the procedure .


Randomized groups had similar demographics ( @ @ years , @ % male , @ % American Society of Anesthesiologists class III-IV ) and a balanced distribution of procedures .


The mean lowest oxygen saturation during the procedure was significantly lower in the propofol group as compared to the midazolam group ( @ @ vs. @ @ % , p = @ ) .


Patients randomized to propofol showed more episodes of hypoxemia ( @ vs. @ % , p = @ ) and hypotension ( @ vs. @ % , p < @ ) .


No procedure had to be aborted .


None of the patients required an artificial airway , mechanical ventilation or intensive care unit care , and none died .


As assessed by the surrogate marker hypoxemia , propofol should not be considered the first choice for sedation in medical thoracoscopy .


Given that the observed prevalence and time course of critical illness-related corticosteroid insufficiency ( CIRCI ) remain inconsistent in trauma patients , the present study was designed to investigate the prevalence , time course , and effect of CIRCI on the outcome of critically ill patients with multiple injuries .


In this multicenter , prospective cohort study , patients with multiple injuries in seven intensive care units in China were enrolled .


Adrenocorticotropic hormone ( ACTH ) stimulation tests were performed by administering intravenously @ g of synthetic ACTH on Days @ , @ , @ , @ , and @ after traumatic injury .


CIRCI was defined as baseline cortisol level of less than @ g/dL or a cortisol ( difference baseline and highest cortisol level at @ or @ minutes after ACTH stimulation ) less than @ g/dL .


The incidence and time course of CIRCI and @-day mortality were recorded .


CIRCI occurred in @ % ( @ of @ ) of the patients with multiple injuries , including @ patients with total cortisol level of less than @ g/dL and @ patients with cortisol of less than @ g/dL .


Most ( @ % ) diagnosis of CIRCI was made in the first @ hours after traumatic injury .


The CIRCI patients had significantly more severe illness on the day of admission .


At each time point , the baseline cortisol level was comparable between the CIRCI and non-CIRCI patients , while cortisol in the CIRCI group was significantly lower compared with the non-CIRCI group .


The CIRCI patients with a cortisol of less than @ g/dL had a significantly higher @-day mortality ( @ % ) compared with those with a baseline cortisol level of less than @ g/dL ( @ % ) and non-CIRCI patients ( @ % ) .


Only cortisol of less than @ g/dL but not baseline cortisol level of less than @ g/dL seemed to be an independent risk factor for death ( odds ratio , @ ; p = @ ) .


CIRCI is common in critically ill trauma population and usually occurs in the early stages .


Only the results of the ACTH stimulation test but not baseline cortisol level was associated with poor prognosis .


Prognostic study , level II .


To test a pathway through which a tailored , pain management education-coaching intervention could contribute to better cancer pain control through the effects of patients ' communication about pain on physician prescribing of pain medication .


Secondary analysis of data from a randomized controlled trial that tested the effects of a tailored education-coaching intervention on pain control for patients with advanced cancer .


The current analysis focused on a subset of the patients ( n = @ ) who agreed to have their consultations audio-recorded .


Patients ' active communication about pain ( e.g. , expressing questions , concerns , and preferences about pain-related issues ) was coded from audio-recordings .


Change in pain medication was measured by patient self-report .


Improvement in pain control was scored as the difference between baseline pain score and pain reported at @ weeks .


Patients ' pain-related communication was a significant predictor of patient-reported changes in physician prescribing of pain medication ( p < @ ) and mediated the effect of baseline pain on medication change .


Other predictors of change in pain medication were age ( younger ) and having participated in the intervention ( as opposed to usual care ) .


Of the patients reporting adjustment in pain medications , @ % experienced better pain control compared with only @ % of patients reporting no change in pain management ( p < @ ) .


Cancer patients who ask questions , express concerns , and state preferences about pain-related matters can prompt physicians to change their pain management regimen , which in turn may lead to better pain control .


Future research should model pathways through which clinician-patient communication can lead to better cancer outcomes .


Daily life movements require balance ability .


Good balance control is closely related to body stability and its development .


Therefore , balance training is necessary for any age group .


This study proposes the combination of Kinect and virtual reality to build an information platform of interactive scenarios , for practice and evaluation of balance ability .


Real-time monitoring of SpO <formula> _ @ </formula> , pulse rate , velocity and reaction time during the training process is presented for the training activities of elderly physical function .


Based on the indicators of balance ability , this information platform sets out various training activities to improve balance ability , making the supposedly tedious process fun and vivid and leading to much better training results .


The data ( SpO <formula> _ @ </formula> , pulse rate , velocity , reaction time ) collected from this platform can be sorted and analysed , and the results used to evaluate the performance of balance training , and referenced for follow-up planning in the future .


The real-time pulse rate and SpO <formula> _ @ </formula> measurement information indicating the training activities for the elderly to maintain physical function has a positive significance .


A noninvasive and unconstrained real-time method to detect the pulse rate and SpO <formula> _ @ </formula> during exercises is presented .


The results of balance assessment scale testing of BBS and TUG for the experimental group show that effective balance really improved .


The difference between the experimental group and the control group was achieved by using paired t-test .


The data were analysed by the descriptive statistics on significant level of P < @ .


From the training results of the participants , we know that the information platform developed for enhancing balance ability is in line with practical needs .


Furthermore , the fun and interesting game-like exercises it introduces are very helpful in improving balance ability , and certainly in preventing falls .


The primary purpose of the study was to determine whether Multisystemic Therapy adapted for health care settings ( MST-HC ) improved asthma management and health outcomes in high-risk African American adolescents with asthma .


Eligibility included self-reported African American ethnicity , ages @ to @ , moderate to severe asthma , and an inpatient hospitalization or at least @ emergency department visits for asthma in the last @ months .


Adolescents and their families ( N = @ ) were randomized to MST-HC or in-home family support .


Data were collected at baseline and posttreatment ( @ months ) based on an asthma management interview , medication adherence phone diary , and lung function biomarker ( forced expiratory volume in @ s -LSB- FEV@ -RSB- ) .


Analyses were conducted using linear mixed modeling for continuous outcomes and generalized linear mixed modeling for binary outcomes .


In intent-to-treat analyses , adolescents randomized to MST-HC were more likely to improve on @ of the measures of medication adherence and FEV@ .


Per-protocol analysis demonstrated that MST-HC had a medium effect on adherence measures and had a small to medium effect on lung function and the adolescent 's response to asthma exacerbations .


There are few interventions that have been shown to successfully improve asthma management in minority youth at highest risk for poor morbidity and mortality .


MST , a home-based psychotherapy originally developed to target behavior problems in youth , improved asthma management and lung function compared to a strong comparison condition .


Further follow-up is necessary to determine whether MST-HC reduces health care utilization accounting for seasonal variability .


A limitation to the study is that a greater number of participants in the control group came from single-parent families than in the MST group .


Icosapent ethyl ( IPE ) is a high-purity prescription form of eicosapentaenoic acid ( EPA ) ethyl ester approved to reduce triglyceride levels in patients with severe ( @ mmol/L ) hypertriglyceridemia .


EPA , the active metabolite of IPE , is mainly metabolized via - oxidation , and studies suggest that omega-@ fatty acids such as EPA may have antithrombotic effects .


The objective of this study was to evaluate the effect of IPE on the pharmacokinetic and anticoagulation pharmacodynamics of warfarin , a substrate of cytochrome P@ @C@-mediated metabolism .


Healthy adults received oral warfarin ( @ mg ) on day @ , oral IPE ( @ g/day ) on days @-@ , and co-administration on Day @ .


Primary pharmacokinetic end points were area under the concentration-versus-time curve from zero to infinity ( AUC ( @ - ) ) and maximum plasma concentration ( C ( max ) ) for R - and S-warfarin ; pharmacodynamic end points were area under the international normalized ratio ( INR ) effect-time curve after the warfarin dose ( AUC ( INR ) ) and maximum INR ( INR ( max ) ) .


Twenty-five subjects completed the study .


AUC ( @ - ) and C max ratios of geometric means for both R - and S-warfarin following co-administration of warfarin with versus without IPE were within the @ % confidence intervals of @-@ @ .


AUC ( INR ) , INR ( max ) , and ratios were also similar .


IPE @ g/day did not significantly change the single-dose AUC ( @ - ) or C ( max ) of R - and S-warfarin or the anticoagulation pharmacodynamics of warfarin when co-administered as racemic warfarin at @ mg .


Co-administration of these drugs was safe and well tolerated in this study of healthy adult subjects .


The publication of protocols by medical journals is increasingly becoming an accepted means for promoting good quality research and maximising transparency .


Recently , Finfer and Bellomo have suggested the publication of statistical analysis plans ( SAPs ) .


The aim of this paper is to make public and to report in detail the planned analyses that were approved by the Trial Steering Committee in May @ for the principal papers of the PACE ( Pacing , graded Activity , and Cognitive behaviour therapy : a randomised Evaluation ) trial , a treatment trial for chronic fatigue syndrome .


It illustrates planned analyses of a complex intervention trial that allows for the impact of clustering by care providers , where multiple care-providers are present for each patient in some but not all arms of the trial .


The trial design , objectives and data collection are reported .


Considerations relating to blinding , samples , adherence to the protocol , stratification , centre and other clustering effects , missing data , multiplicity and compliance are described .


Descriptive , interim and final analyses of the primary and secondary outcomes are then outlined .


This SAP maximises transparency , providing a record of all planned analyses , and it may be a resource for those who are developing SAPs , acting as an illustrative example for teaching and methodological research .


It is not the sum of the statistical analysis sections of the principal papers , being completed well before individual papers were drafted .


The purpose of this study was to evaluate the efficacy of a self-guided CD-ROM program ( `` Headstrong '' ) containing cognitive-behavioral self-management strategies versus an educational CD-ROM program for treating headaches , headache-related disability , and quality of life .


Participants were @ children ages @-@years with migraine recruited from one university medical center and two children 's hospital headache clinics .


Participants were randomly assigned to complete the Headstrong or educational control CD-ROM program over a @-week period .


Data on headache frequency , duration , and severity , migraine-related disability , and quality of life ( QOL ) were obtained at baseline , post-intervention , and @-months post-intervention .


At post-intervention , Headstrong resulted in lower severity ( on a @-point scale ) than the control group by child report ( @ SD vs. @ SD , p = @ , ES = @ ) .


At @-months post-intervention , parents reported less migraine-related disability ( on the PedMIDAS ) in the Headstrong group compared to the control group ( @ SD vs. @ SD ; p = @ , ES = @ ) .


There were no other group differences at post treatment or at @-months post-intervention .


When compared to an educational control , Headstrong resulted in lower pain severity at post-treatment and less migraine-related disability at @-months post-intervention , by child and parent report respectively .


Headache frequency and quality of life did not change more for Headstrong versus control .


Additional research is needed on the Headstrong Program to increase its efficacy and to test it with a larger sample recruited from multiple centers simultaneously .


Vaccines may have non-specific effects .


An observational study from Guinea-Bissau suggested that oral polio vaccine at birth ( OPV@ ) provided with Bacillus Calmette-Gurin ( BCG ) vaccine was associated with down-regulation of the immune response to BCG vaccine @ weeks later .


Based on the previous finding , we wanted to test our a priori hypothesis that OPV would dampen the immune response to BCG , and secondarily to test immune responses to other antigens .


The study was conducted at the Bandim Health Project in Guinea-Bissau in @-@ .


Infants were randomised to OPV@ + BCG versus BCG alone at birth , and subsequently randomised to have a blood sample taken at @ , @ or @ weeks post-randomisation .


Excreted levels of cytokines ( IL-@ , IL-@ , IL-@ , TNF - and IFN - ) were measured from whole blood in vitro stimulations with a panel of recall vaccine antigens ( BCG , PPD , OPV ) , mitogen ( PHA ) or innate agonists ( LPS , Pam@cys , PolyI : C ) .


Additionally , we measured the local reaction to BCG , white blood cell distribution , C-reactive protein ( CRP ) and retinol-binding protein ( RBP ) .


Cytokine production was analysed as the prevalence ratios of responders above the median .


Blood samples from @ infants ( @ OPV@ + BCG ; @ BCG alone ) were analysed .


There were no strong differences in effects @ , @ and @ weeks post-randomisation and subsequent analyses were performed on the pooled data .


As hypothesised , receiving OPV@ + BCG versus BCG alone was associated with significantly lower prevalence of IFN - responses to PPD ( prevalence ratio ( PR ) : @ ( @-@ @ ) ) and reduced IL-@ to PPD ( PR : @ ( @-@ @ ) ) .


No effects were observed for CPR , RBP , white blood cell distribution , or BCG scar prevalence .


The results corroborate that OPV attenuates the immune response to co-administered BCG at birth .


To investigate the effects of a low fermentable , oligosaccharides , disaccharides , monosaccharides and polyols diet ( LFD ) and the probiotic Lactobacillus rhamnosus GG ( LGG ) in irritable bowel syndrome ( IBS ) .


Randomised , unblinded controlled trial on the effect of @-wk treatment with LFD , LGG or a normal Danish/Western diet ( ND ) in patients with IBS fulfilling Rome III diagnostic criteria , recruited between November @ and April @ .


Patients were required to complete on a weekly basis the IBS severity score system ( IBS-SSS ) and IBS quality of life ( IBS-QOL ) questionnaires in a specially developed IBS web self-monitoring application .


We investigated whether LFD or LGG could reduce IBS-SSS and improve QOL in IBS patients .


One hundred twenty-three patients ( median age @ years , range : @-@ years ) , @ ( @ % ) females were randomised : @ to LFD , @ to LGG and @ to ND .


A significant reduction in mean SD of IBS-SSS from baseline to week @ between LFD vs LGG vs ND was revealed : @ @ vs @ @ , @ @ vs @ @ , P < @ .


Adjusted changes of IBS-SSS for baseline covariates showed statistically significant reduction of IBS-SSS in LFD group compared to ND ( IBS-SSS score @ ; @ % CI : @-@ , P < @ ) , but not in LGG compared to ND ( IBS-SSS score @ ; @ % CI : @-@ , P = @ ) .


IBS-QOL was not altered significantly in any of the three groups : mean SD in LFD @ @ vs LGG @ @ , LFD @ @ vs ND @ @ , P = @ .


Both LFD and LGG are efficatious in patients with IBS .


To determine the efficacy of the Airtraq versus the McCoy laryngoscope as intubation devices with the neck stabilized by a rigid cervical collar .


Prospective , randomized , double-blinded study .


Jawaharlal Nehru Medical College .


@ ASA physical status @ , @ , and @ patients , aged @-@ years , scheduled for various surgical procedures requiring tracheal intubation for surgical anesthesia .


Patients were randomly allocated to undergo intubation with the McCoy ( n = @ ) or Airtraq ( n = @ ) laryngoscope .


Differences in intubation times between the Airtraq and the McCoy laryngoscope , modified Cormack-Lehane score , percentage of glottic opening ( POGO ) score , and airway trauma were compared .


Overall intubation success rates were @ % with both devices and a similar number of intubation attempts were required .


However , the mean ( SD ) time required for successful intubation was shorter with the Airtraq ( @ @ sec ) than the McCoy laryngoscope ( @ @ sec ; P < @ ) .


The frequencies of intubation complications were similar .


Esophageal intubation occurred in @ cases but only with the McCoy laryngoscope .


Intubation time was shorter with the Airtraq than the McCoy laryngoscope , even though the overall success rates between the two devices were similar .


Physicians may be important sources of sexuality information and preventive services , and one-on-one confidential time during health maintenance visits is recommended to allow discussions of sexual development , behavior , and risk reduction .


However , little is known about the occurrence and characteristics of physician-adolescent discussions about sexuality .


To examine predictors of time spent discussing sexuality , level of adolescent participation , and physician and patient characteristics associated with sexuality discussions during health maintenance visits by early and middle adolescents .


Observational study of audio-recorded conversations between @ adolescents ( mean age , @ years ; @ % female ; @ % white ; @ % African American ) and @ physicians ( @ % pediatricians ; @ % white ; @ % female ; mean age , @ years ; mean -LSB- SD -RSB- duration in practice , @ -LSB- @ -RSB- years ) coded for sexuality content at @ clinics ( @ academic and @ community-based practices ) located throughout the Raleigh/Durham , North Carolina , area .


Total time per visit during which sexuality issues were discussed .


RESULTS One hundred sixty-five ( @ % ) of all visits had some sexual content within it .


The average time of sexuality talk was @ seconds ( @ % @ seconds ; @ % @-@ seconds ; and @ % @ seconds ) .


Ordinal logistic regression ( outcome of duration : @ , @-@ , or @ seconds ) , adjusted for clustering of patients within physicians , found that female patients ( odds ratio -LSB- OR -RSB- = @ ; @ % CI , @-@ @ ) , older patients ( OR = @ ; @ % CI , @-@ @ ) , conversations with explicit confidentiality discussions ( OR = @ ; @ % CI , @-@ @ ) , African American adolescents ( OR = @ ; @ % CI , @-@ @ ) , and longer overall visit ( OR = @ ; @ % CI , @-@ @ ) were associated with more sexuality talk , and Asian physicians were associated with less sexuality talk ( OR = @ ; @ % CI , @-@ @ ) .


In addition , the same significant associations between adolescent , physician , and visit characteristics were significantly associated with greater adolescent participation .


Our study may be the first to directly observe sexuality talk between physicians and adolescents .


We found that one-third of all adolescents had annual visits without any mention of sexuality issues ; when sexuality talk occurred , it was brief .


Research is needed to identify successful strategies physicians can use to engage adolescents in discussions about sexuality to help promote healthy sexual development and decision making .