The @MR will be based on consensus criteria and the relevant literature and will be performed by the patient 's elderly care physician in collaboration with a pharmacist .


Primary outcomes-the difference in proportion of residents who successfully discontinued inappropriate medication between the intervention and control group at follow-up .


Secondary outcomes-undertreatment , exposure to anticholinergic and sedative medicines , neuropsychiatric symptoms , cognitive function , falls , hospital admission , quality of life and cost-effectiveness .


Long-acting injectable formulations of antipsychotics are treatment alternatives to oral agents .


To assess the efficacy of aripiprazole once-monthly compared with oral aripiprazole for maintenance treatment of schizophrenia .


A @-week , double-blind , active-controlled , non-inferiority study ; randomisation ( @:@:@ ) to aripiprazole once-monthly @ mg , oral aripiprazole ( @-@ mg/day ) or aripiprazole once-monthly @ mg ( a dose below the therapeutic threshold for assay sensitivity ) .


clinicaltrials.gov , NCT@ . )


A total of @ patients were screened , and @ responders to oral aripiprazole were randomised .


Kaplan-Meier estimated impending relapse rates at week @ were @ % for aripiprazole once-monthly @ mg and @ % for oral aripiprazole .


This difference ( -@ % , @ % CI -@ to @ ) excluded the predefined non-inferiority margin of @ % .


Treatments were superior to aripiprazole once-monthly @ mg ( @ % , P < or = @ ) .


Aripiprazole once-monthly @ mg was non-inferior to oral aripiprazole , and the reduction in Kaplan-Meier estimated impending relapse rate at week @ was statistically significant v. aripiprazole once-monthly @ mg .


Persons with serious mental illness ( SMI ) are disproportionately burdened by premature mortality .


This disparity is exacerbated by poor continuity of care with the health system .


The Veterans Health Administration ( VA ) developed Re-Engage , an effective population-based outreach program to identify veterans with SMI lost to care and to reconnect them with VA services .


However , such programs often encounter barriers getting implemented into routine care .


Adaptive designs are needed when the implementation intervention requires augmentation within sites that do not initially respond to an initial implementation intervention .


This protocol describes the methods used in an adaptive implementation design study that aims to compare the effectiveness of a standard implementation strategy ( Replicating Effective Programs , or REP ) with REP enhanced with External Facilitation ( enhanced REP ) to promote the uptake of Re-Engage .


This study employs a four-phase , two-arm , longitudinal , clustered randomized trial design .


VA sites ( n = @ ) across the United States with a designated Re-Engage provider , at least one Veteran with SMI lost to care , and who received standard REP during a six-month run-in phase .


Subsequently , @ sites with inadequate uptake were stratified at the cluster level by geographic region ( n = @ ) and VA regional service network ( n = @ ) and randomized to REP ( n = @ ) vs. enhanced REP ( n = @ ) in phase two .


The primary outcome was the percentage of veterans on each facility outreach list documented on an electronic web registry .


The intervention was at the site and network level and consisted of standard REP versus REP enhanced by external phone facilitation consults .


At @ months , enhanced REP sites returned to standard REP and @ sites with inadequate participation received enhanced REP for six months in phase three .


Secondary implementation outcomes included the percentage of veterans contacted directly by site providers and the percentage re-engaged in VA health services .


Adaptive implementation designs consisting of a sequence of decision rules that are tailored based on a site 's uptake of an effective program may produce more relevant , rapid , and generalizable results by more quickly validating or rejecting new implementation strategies , thus enhancing the efficiency and sustainability of implementation research and potentially leading to the rollout of more cost-efficient implementation strategies .


This study aims to obtain preliminary data on the efficacy of yoga for reducing self-reported menopausal hot flashes in a randomized study including an attention control group .


We randomized @ late perimenopausal women ( @-@ mo of amenorrhea ) and postmenopausal women ( > @ mo of amenorrhea ) -- aged @ to @ years and who experienced at least four hot flashes per day , on average , for at least @ weeks -- to one of three groups : yoga , health and wellness education ( HW ) , and wait list ( WL ) .


Yoga and HW classes consisted of weekly @-minute classes for @ weeks .


All women completed daily hot flash diaries throughout the trial ( @ wk ) to track the frequency and severity of hot flashes .


The mean hot flash index score is based on the number of mild , moderate , severe , and very severe hot flashes .


Hot flash frequency declined significantly across time for all three groups , with the strongest decline occurring during the first week .


There was no overall significant difference in hot flash frequency decrease over time by treatment groups , but the yoga and HW groups followed similar patterns and showed greater decreases than the WL group .


On week @ , women in the yoga group reported an approximately @ % decrease in hot flash frequency , women in the HW group reported a @ % decrease , and women in the WL group reported a @ % decrease .


The hot flash index showed a similar pattern .


Results suggest that yoga can serve as a behavioral option for reducing hot flashes but may not offer any advantage over other types of interventions .


Symptoms of posttraumatic stress disorder are a well-recognized phenomenon in mothers of preterm infants , with implications for maternal health and infant outcomes .


This randomized controlled trial evaluated @-month outcomes from a skills-based intervention developed to reduce symptoms of posttraumatic stress disorder , anxiety , and depression .


One hundred five mothers of preterm infants were randomly assigned to ( @ ) a @ - or @-session intervention based on principles of trauma-focused cognitive behavior therapy with infant redefinition or ( @ ) a @-session active comparison intervention based on education about the NICU and parenting of the premature infant .


Outcome measures included the Davidson Trauma Scale , the Beck Depression Inventory II , and the Beck Anxiety Inventory .


Participants were assessed at baseline , @ to @ weeks after birth , and @ months after the birth of the infant .


At the @-month assessment , the differences between the intervention and comparison condition were all significant and sizable and became more pronounced when compared with the @ - to @-week outcomes : Davidson Trauma Scale ( Cohen 's d = -@ , P < @ ) , Beck Anxiety Inventory ( Cohen 's d = -@ , P = @ ) , Beck Depression Inventory II ( Cohen 's d = -@ , P = @ ) .


However , there were no differences in the effect sizes between the @ - and @-session interventions .


A brief @-session intervention based on principles of trauma-focused cognitive behavior therapy was effective at reducing symptoms of trauma , anxiety , and depression in mothers of preterm infants .


Mothers showed increased benefits at the @-month follow-up , suggesting that they continue to make use of techniques acquired during the intervention phase .


Diabetes mellitus is an independent risk factor for lacunar strokes .


Few data are available regarding patient features , infarct location , and recurrent vascular events for patients with diabetes mellitus with lacunar stroke .


We compared features at study entry and prognosis during @ years of follow-up of patients with diabetes mellitus versus patients without diabetes mellitus with recent lacunar stroke participating in the Secondary Prevention of Small Subcortical Strokes ( SPS@ ) randomized trial .


Among the @ participants , the prevalence of diabetes mellitus was @ % with a mean duration of @ years .


Diabetes mellitus was independently associated with slightly younger age ( @ versus @ years ; P < @ ) , Hispanic ethnicity ( @ % versus @ % ; P < @ ) , ischemic heart disease ( @ % versus @ % ; P = @ ) , and peripheral vascular disease ( @ % versus @ % ; P < @ ) .


Patients with diabetes mellitus more frequently had intracranial stenosis @ % ( P < @ ) , infarcts involving the brain stem or cerebellum ( P < @ ) , and more extensive white matter abnormalities ( P < @ ) .


Patients with diabetes mellitus were almost twice as likely to have a recurrent stroke ( hazard ratio -LSB- HR -RSB- , @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ) , recurrent ischemic stroke ( HR , @ ; @ % CI , @-@ @ ) , disabling/fatal stroke ( HR , @ ; @ % CI , @-@ @ ) , myocardial infarction ( HR , @ ; @ % CI , @-@ @ ) , and death ( HR , @ @ % CI , @-@ @ ) compared with patients without diabetes mellitus .


Patients with diabetes mellitus with lacunar stroke have a distinctive clinical profile that includes double the prevalence of systemic and intracranial atherosclerosis , preferential involvement of the posterior circulation , and a poor prognosis for recurrent stroke and death .


Initial treatment for amblyopia of the fellow eye with patching and atropine sulfate eyedrops improves visual acuity .


Long-term data on the durability of treatment benefit are needed .


To report visual acuity at @ years of age among patients who were younger than @ years when enrolled in a treatment trial for moderate amblyopia .


In a multicenter clinical trial , @ children with amblyopia ( visual acuity , @/@ to @/@ ) were randomly assigned to patching ( minimum of @ h/d ) or atropine sulfate eyedrops , @ % ( @ drop daily ) , for @ months .


Treatment after @ months was at the discretion of the investigator .


Two years after enrollment , an unselected subgroup of @ children were enrolled into long-term follow-up .


Initial treatment with patching or atropine with subsequent treatment at investigator discretion .


Visual acuity at @ years of age with the electronic Early Treatment Diabetic Retinopathy Study test in amblyopic and fellow eyes .


Mean visual acuity in the amblyopic eye measured in @ participants at @ years of age was @ logMAR ( approximately @/@ ) ; @ % of amblyopic eyes had visual acuity of @/@ or better and @ % , @/@ or better .


Mean interocular acuity difference ( IOD ) at @ years of age was @ logMAR ( @ lines ) ; @ % had an IOD of @ or more lines and @ % , @ or more lines .


Treatment ( other than spectacles ) was prescribed for @ participants ( @ % ) aged @ to @ years .


Mean IOD was similar at examinations at @ and @ years of age ( @ and @ logMAR lines , respectively ; P = @ ) .


Better visual acuity at the @-year examination was achieved in those who were younger than @ years at the time of entry into the randomized clinical trial ( mean logMAR , @ ) compared with those aged @ to @ years ( mean logMAR , @ ; P < @ ) .


When we compared subgroups based on original treatment with atropine or patching , no significant differences were observed in visual acuity of amblyopic and fellow eyes at @ years of age ( P = @ and P = @ , respectively ) .


At @ years of age , most children treated for moderate amblyopia when younger than @ years have good visual acuity , although mild residual amblyopia is common .


The outcome is similar regardless of initial treatment with atropine or patching .


The results indicate that improvement occurring with amblyopia treatment is maintained until at least @ years of age .


Total knee replacement ( TKR ) is a cost-effective treatment option for severe osteoarthritis ( OA ) .


While prevalence of OA is higher among blacks than whites , TKR rates are lower among blacks .


Physicians ' implicit preferences might explain racial differences in TKR recommendation .


The objective of this study was to evaluate whether the magnitude of implicit racial bias predicts physician recommendation of TKR for black and white patients with OA and to assess the effectiveness of a web-based instrument as an intervention to decrease the effect of implicit racial bias on physician recommendation of TKR .


In this web-based study , @ family and internal medicine physicians were given a scenario describing either a black or white patient with severe OA refractory to medical treatment .


Questionnaires evaluating the likelihood of recommending TKR , perceived medical cooperativeness , and measures of implicit racial bias were administered .


The main outcome measures included TKR recommendation , implicit racial preference , and medical cooperativeness stereotypes measured with implicit association tests .


Subjects displayed a strong implicit preference for whites over blacks ( P < @ ) and associated `` medically cooperative '' with whites over blacks ( P < @ ) .


Physicians reported significantly greater liking for whites over blacks ( P < @ ) and reported believing whites were more medically cooperative than blacks ( P < @ ) .


Participants reported providing similar care for white and black patients ( P = @ ) but agreed that subconscious biases could influence their treatment decisions ( P < @ ) .


There was no significant difference in the rate of recommendation for TKR when the patient was black ( @ % ) versus white ( @ % ) ( P = @ ) , and neither implicit nor explicit racial biases predicted differential treatment recommendations by race ( all P > @ ) .


Although participants were more likely to recommend TKR when completing the implicit association test before the decision , patient race was not significant in the association ( P = @ ) .


Physicians possessed explicit and implicit racial biases , but those biases did not predict treatment recommendations .


Clinicians ' biases about the medical cooperativeness of blacks versus whites , however , may have influenced treatment decisions .


Antiretroviral pre-exposure prophylaxis ( PrEP ) is a novel HIV prevention strategy for which adherence is a known determinant of efficacy .


Blood concentrations of PrEP medications are one objective marker of adherence .


In a placebo-controlled PrEP efficacy trial of tenofovir disoproxil fumarate ( TDF ) and TDF with emtricitabine ( FTC/TDF ) among @ African women and men with an HIV-infected partner , we measured plasma tenofovir concentrations from participants in the active PrEP arms : @ HIV seroconverters ( cases ) and @ randomly selected controls who remained uninfected .


Among controls , @ % of visits had tenofovir concentrations > @ ng/mL , consistent with steady-state daily dosing , compared with @ % of cases at the visit HIV was first detected .


Pill count data indicated that @ % of controls and @ % of cases had > @ % adherence for these same visits .


The estimated protective effect of PrEP against HIV , based on concentrations > @ ng/mL , was @ % ( @ % confidence interval : @ to @ , P < @ ) for individuals receiving TDF and @ % ( @ % confidence interval : @ to @ , P = @ ) for individuals receiving FTC/TDF .


Controls had consistent patterns of PrEP concentrations during follow-up ; among the @ % with concentrations > @ ng/mL at month @ , @ % maintained this concentration at month @ .


Only @ of @ seroconverters seemed to be consistently adherent to PrEP .


Tenofovir concentrations > @ ng/mL were associated with older age and shorter time on study ; concentrations @ ng/mL occurred more commonly when participants reported no sex with their HIV-infected partner .


Plasma concentrations of tenofovir consistent with daily dosing were highly predictive of protection from HIV acquisition .


Most of those who took PrEP seemed to have high and consistent adherence .


Postoperative vision loss complicates an estimated @ in @,@ prone spine surgical cases .


This complication has been attributed to ischemic optic neuropathy , with one proposed reason being perioperative elevations in intraocular pressure ( IOP ) .


Previous research has studied the effects of table inclination on IOP in awake volunteers ; however , the effects in spine surgery patients have not been investigated for reverse Trendelenburg positioning using a prospective , randomized controlled study design .


To assess the effect of table inclination on IOP in patients undergoing prone spine surgery .


Single-center , prospective randomized controlled study .


Nineteen patients with no history of eye pathology , undergoing prone spine surgery at Dwight D. Eisenhower Army Medical Center , were randomly assigned to a table position : neutral , @ , or @ of reverse Trendelenburg .


Intraocular pressure , mean arterial pressure ( MAP ) , estimated blood loss , fluid resuscitation , and ophthalmologic complication were assessed before and after induction and at incremental times during surgery , beginning at @ minutes , @ minutes , and @-minute increments thereafter .


Multivariate analyses evaluated surgical time , IOP , MAP , estimated blood loss , and fluid resuscitation as a function of table inclination to determine the effect of patient positioning on identified risk factors for postoperative vision loss .


Surgical times ranged from @ to @ minutes .


A rapid increase in IOP was noted after prone positioning , with continued increases as time elapsed .


The neutral group exhibited statistically higher IOP compared with the @ reverse Trendelenburg group after @ minutes and the @ group through @ minutes of surgery .


The trend continued through @ minutes ; however , because of a lack of power , we were unable to determine the statistical significance .


There were no statistically significant differences between the @ and @ reverse Trendelenburg groups .


Reverse Trendelenburg positioning elicits decreased IOP compared with prone positioning for surgery times less than @ minutes .


Ten degrees of reverse Trendelenburg attenuate the rise in IOP during prone spine surgery superiorly in comparison with @ .


No significant complications were associated with reverse Trendelenburg positioning .


We aimed to examine the efficacy of two psycho-oncological interventions in anxiety , depression , and self-perceived as well as physiological stress in inpatients with gynaecological cancer .


Forty-five women were included in the trial .


Thirty-five were categorized as being at high risk of anxiety and depression , and were randomized to either a single psycho-oncological therapy session or a single-session relaxation intervention .


A significant decrease in anxiety -LSB- mean ( t@ ) = @ , mean ( t@ ) = @ , p = @ -RSB- and depression -LSB- mean ( t@ ) = @ , mean ( t@ ) = @ , p < @ -RSB- was observed in the psycho-oncological intervention group .


In the relaxation group , anxiety also significantly decreased -LSB- mean ( t@ ) = @ , mean ( t@ ) = @ , p = @ -RSB- , whereas depression did not .


A comparative analysis of both interventions showed a trend in favour of psycho-oncological therapy for the treatment of depression ( F = @ , p = @ ) .


However , self-reported stress ( p = @ ) and different objective stress parameters only significantly decreased in the relaxation group .


Psycho-oncological interventions should represent an essential part of interdisciplinary care for gynaecological cancer patients .


Both types of intervention may reduce anxiety .


However , the single psycho-oncological therapy session might be slightly more effective in treating depression , whereas the single-session relaxation intervention seems to have a stronger effect on physiological stress parameters .


Cash transfers ( CTs ) are increasingly used as a strategy to alleviate poverty and improve child health outcomes in low - and middle-income countries .


The Child Support Grant ( CSG ) is the largest CT programme in South Africa , and on the continent , targeting poor children from birth until the age of @ with a monthly sum of R@ ( USD@ ) .


Evidence on the CSG shows that early receipt of the grant is associated with improved child health outcomes .


Since its implementation , one of the major concerns about the grant has been take-up rates , particularly for younger children .


This paper reports results on take-up rates for @-week-old infants residing in an urban township in South Africa .


This is a descriptive study utilising data from a community-based , cluster-randomised trial which evaluated a programme providing pregnancy and post-natal home visits by community health workers to @,@ mothers in Umlazi township , South Africa .


At the @-week visit , half ( @ % ) of the mothers who had enrolled in the study had applied for the CSG on behalf of their children , while @ % of the mothers who had not applied were still planning to apply .


Only @ % ( @,@ ) of all children had received the CSG .


In this study , many mothers had not applied for the CSG in the first few months after delivery , and only a third of children had accessed the grant .


Further research is needed to understand what the current barriers are that prevent mothers from applying for this important form of social protection in the early months after delivery .


To observe the therapeutic effect of different schemes of mild moxibustion for treatment of ( yang-deficiency induced cold-accumulation type ) knee osteoarthritis ( KOA ) .


Fifty-nine KOA patients were chosen and randomly divided into control group ( n = @ ) and test group ( n = @ ) .


Patients of the control group were treated by mild moxi - bustion of Neixiyan ( EX-HE@ ) and Waixiyan ( ST @ ) for @ min , once daily for @ days ( two courses ) , and those of the test group were treated by mild moxibustion of EX-HE @ and ST @ for @ mini once daily for @ days ( the same to control group ) , followed by moxibustion of Yaoyangguan ( GV @ ) and Mingmen ( GV @ ) once daily for next @ days more .


In addition , patients of the two groups were also treated by routine acupuncture stimulation of EX-HE @ , ST @ , Yanglingquan ( GB @ ) , Kunlun ( BL @ ) , etc. .


The interval between two therapeutic courses was one day .


The Lysholm Knee Score Scale ( LKSS ) was used to evaluate the therapeutic effect .


Visual analogue scale ( VAS ) was employed to assess the patient 's knee-joint pain severity ( arthralgia ) , and scores of morning stiffness , arthrocele , and walking restraint degree of the knee-joint were also evaluated before and after the treatment .


After the treatment , the scores of VAS , morning stiffness , arthrocele and walking restraint degree of the knee-joint of both groups were significantly decreased ( P < @ ) , and the scores of the test group were obviously lower than those of the con - trol group ( P < @ ) .


The effective rate of the test group was @ % ( @/@ ) which was obviously higher than that ( @ % , @/@ ) of the control group ( P < @ ) .


Mild moxibustion of Neixiyan ( EX-HE @ ) and Waixiyan ( ST @ , local acu - points ) , and Yaoyangguan ( GV @ ) and Mingmen ( GV @ ) has a better therapeutic effect for KOA patients than moxibustion of local acupoints only .


Despite the commonly observed comorbidity of alcohol and tobacco use disorders and years of research , the mechanism underlying concurrent use of alcohol and tobacco is not yet clear .


In this study , we used functional magnetic resonance imaging ( fMRI ) to investigate the relationship between brain responses to alcohol and smoking cues in @ subjects with episodic drinking and regular smoking .


fMRI data were collected from two studies performing an alcohol-craving task and a smoking-craving task .


First , we identified brain voxels significantly activated for both substance cues and then associated the activation of these voxels with various alcohol - and nicotine-dependence measures .


Significant clusters ( cluster-wise p < @ ) correlated with behavioral assessments were extracted , and clusters identified from both cues were compared .


The association tests with various dependence scores showed that the loss of behavioral control subcategory in the Alcohol Dependence Scale was significantly correlated with brain activation of the posterior cingulate cortex ( PCC ) and right posterior insula regardless of cue types .


Our findings suggest that the PCC and right posterior insula , each playing a role in the salience network , are affected significantly by impaired control for alcohol and in turn influence brain responses to not only alcohol but also smoking cues , providing insight to neuronal mechanisms for concurrent use or comorbidity of alcohol and nicotine dependence .


To test the effectiveness of tailored quitline ( telephone ) counselling among smoking parents recruited into cessation support through their children 's primary schools .


Two-arm randomized controlled trial with @ - and @-month follow-up .


Proactive telephone counselling was administered by the Dutch national quitline .


Smoking parents were recruited through their children 's primary schools and received either intensive quitline support in combination with tailored supplementary materials ( n = @ ) or a standard self-help brochure ( n = @ ) .


The primary outcome was @-day point-prevalence abstinence at @-month follow-up .


Also measured were baseline characteristics , use of and adherence to nicotine replacement therapy and pharmacotherapy , smoking characteristics and implementation of a home smoking ban .


Parents who received quitline counselling were more likely to report @-day point-prevalence abstinence at @-month assessment -LSB- @ versus @ % , odds ratio ( OR ) = @ , confidence interval ( CI ) = @-@ @ -RSB- than those who received a standard self-help brochure .


Parents who received quitline counselling were more likely to use nicotine replacement therapy ( P < @ ) than those who received a standard self-help brochure .


Among parents who did not achieve abstinence , those who received quitline counselling smoked fewer cigarettes at @-month ( P < @ ) and @-month assessment ( P < @ ) , were more likely to make a quit attempt ( P < @ ) , to achieve @ hours ' abstinence ( P < @ ) and to implement a complete home smoking ban ( P < @ ) .


Intensive quitline support tailored to smoking parents is an effective method for helping parents quit smoking and promoting parenting practices that protect their children from adverse effects of smoking .


Prescription of generic products is a way to reduce health expense .


Bioequivalence is the most appropriate procedure to evaluate the quality and therapeutic efficacy of a generic product .


Generic prescriptions are a strategic choice in Tunisia .


We expose in this work , a bioequivalence study witch compare a generic ( test ) product : DIABENIL * manufactured by a Tunisian pharmaceutical industry Dar Essaidaly to the innovative ( reference ) product : DAONIL * of Aventis pharma laboratories .


The bioequivalence of two glibenclamide @-mg tablets was determined in healthy human , adult volunteers after a single dose in a randomized cross-over in double blind study .


Test and reference were administered to twenty-four healthy volunteers of both sexes after overnight fasting .


In total , @ Blood samples were collected before and following the administration of the drug .


Serum concentrations of glibenclamide were determined by validated HPLC method .


The pharmacokinetic parameters AUC@t , AUC@ , Cmax and tmax were tested for bioequivalence .


All parameters showed bioequivalence between both formulations as their confidence intervals were within the bioequivalence acceptable range of @-@ @ limits .


We conclude that the two formulations exhibited comparable pharmacokinetic profiles and that the two products can be considered interchangeable in medical practice .


Because lithium exerts neuroprotective effects in preclinical models of polyglutamine disorders , our objective was to assess the safety and efficacy of lithium carbonate ( @-@ @ milliequivalents per liter ) in patients with Machado-Joseph disease ( spinocerebellar ataxia type @ -LSB- MJD/SCA@ -RSB- ) .


For this phase @ , single-center , double-blind , parallel , placebo-controlled trial ( ClinicalTrials.gov identifier NCT@ ) , @ patients who had MJD/SCA@ with a disease duration @ years and an independent gait were randomly assigned ( @:@ ) to receive either lithium or placebo .


After @ weeks , @ adverse events were reported , including @ % in the lithium group ( P = @ ; primary safety outcome ) .


Sixty patients ( @ in the placebo group and @ in the lithium group ) were analyzed for efficacy ( intention-to-treat analysis ) .


Mean progression between groups did not differ according to scores on the Neurological Examination Score for the Assessment of Spinocerebellar Ataxia ( NESSCA ) after @ weeks ( -@ ; @ % confidence interval , -@ to @ ; primary efficacy outcome ) .


The lithium group exhibited minor progression on the PATA speech-rate ( P = @ ) , the nondominant Click Test ( P = @ ) , the Spinocerebellar Ataxia Functional Index ( P = @ ) , and the Composite Cerebellar Functional Score ( P = @ ) .


Lithium was safe and well tolerated , but it had no effect on progression when measured using the NESSCA in patients with MJD/SCA@ .


This slowdown in secondary outcomes deserves further clarification .


Dihydrotestosterone is the main androgen causative of androgenetic alopecia , a psychologically and physically harmful condition warranting medical treatment .


We sought to compare the efficacy and safety of dutasteride ( type @ and @ @-alpha reductase inhibitor ) with finasteride ( type @ @-alpha reductase inhibitor ) and placebo in men with androgenetic alopecia .


Men aged @ to @ years with androgenetic alopecia were randomized to receive dutasteride ( @ , @ , or @ mg/d ) , finasteride ( @ mg/d ) , or placebo for @ weeks .


The primary end point was hair count ( @-cm diameter ) at week @ .


Other assessments included hair count ( @-cm diameter ) and width , photographic assessments ( investigators and panel ) , change in stage , and health outcomes .


In total , @ men were randomized .


Hair count and width increased dose dependently with dutasteride .


Dutasteride @ mg significantly increased hair count and width in a @-cm diameter and improved hair growth ( frontal view ; panel photographic assessment ) at week @ compared with finasteride ( P = @ , P = @ , and P = @ , respectively ) and placebo ( all P < @ ) .


The number and severity of adverse events were similar among treatment groups .


The study was limited to @ weeks .


Dutasteride increased hair growth and restoration in men with androgenetic alopecia and was relatively well tolerated .


We aimed to compare the efficacy of isosorbide mononitrate and doxazosin in the treatment of lower urinary tract symptoms ( LUTS ) .


@ patients with LUTS were included in this randomized clinical study .


All patients were evaluated with uroflowmetry , post-void residual ( PVR ) urine , prostate volume , International Prostate Symptom Score ( IPSS ) , serum PSA , urinalysis and culture .


@ patients were prescribed doxazosin for @ weeks , another @ were prescribed isosorbide mononitrate for @ weeks .


Urologic re-evaluation was done at the end of the study .


@ patients completed the study .


The mean age of patients was @ @ years , the mean PSA value was @ @ ng/ml and the mean prostate volume was @ @ ml .


Doxazosin markedly improved IPSS ( from @ @ to @ @ ) , maximum urinary flow rate ( from @ @ to @ @ ml/s ) and PVR urine ( from @ @ to @ @ ml ) ( p < @ , p < @ , p = @ , respectively ) .


Isosorbide only improved IPSS ( from @ @ to @ @ ) ( p = @ ) .


Daily administration of isosorbide does not seem to be an alternative to - blocker therapy .


Controlled , randomized novel studies are required to establish that whether nitric oxide donors are an effective alternative in LUTS treatment .


Ulinastatin was reported has positive effects on preventing post-ERCP pancreatitis and hyperamylasemia for patients in average risk .


To observe the incidence of post-ERCP pancreatitis and investigate the efficacy and feasibility of using Ulinaststin to prevent post-ERCP pancreatitis .


A total of @ patients were randomized into two arms : an experimental arm using Ulinastatin-containing contrast medium and a control arm using the same contrast medium without Ulinastatin .


Blood amylase and urine amylase-@ were measured at three and twenty-four hours after ERCP procedure .


There were distinct differences in the incidence of post-ERCP pancreatitis and average blood amylase levels in the two arms ( p < @ ) .


Post-ERCP pancreatitis was observed in @ patients ( @ % ) , including @ ( @ % ) patients in the experimental arm , and @ ( @ % ) patients in control arm .


After @ hours of the operation , the average blood amylase levels in control and experimental arm were @ U/L and @ U/L , respectively .


Correspondingly , the levels were @ U/L and @ U/L after @ hours .


But the difference was not statistically significant in urine amylase-@ levels , hemoleukocyte count and operation time .


The exploitation of Ulinastatin in ERCP could decrease the incidence but could not completely prevent the development of post-ERCP pancreatitis .


Malaria due to Plasmodium knowlesi is reported throughout South-East Asia , and is the commonest cause of it in Malaysia .


P. knowlesi replicates every @h and can cause severe disease and death .


Current @ WHO Malaria Treatment Guidelines have no recommendations for the optimal treatment of non-severe knowlesi malaria .


Artemisinin-combination therapies ( ACT ) and chloroquine have each been successfully used to treat knowlesi malaria ; however , the rapidity of parasite clearance has not been prospectively compared .


Malaysia 's national policy for malaria pre-elimination involves mandatory hospital admission for confirmed malaria cases with discharge only after two negative blood films ; use of a more rapidly acting antimalarial agent would have health cost benefits .


P. knowlesi is commonly microscopically misreported as P. malariae , P. falciparum or P. vivax , with a high proportion of the latter two species being chloroquine-resistant in Malaysia .


A unified ACT-treatment protocol would provide effective blood stage malaria treatment for all Plasmodium species .


ACT KNOW , the first randomised controlled trial ever performed in knowlesi malaria , is a two-arm open-label trial with enrolments over a @-year period at three district sites in Sabah , powered to show a difference in proportion of patients negative for malaria by microscopy at @h between treatment arms ( clinicaltrials.gov #NCT @ ) .


Enrolments started in December @ , with completion expected by September @ .


A total sample size of @ is required to give @ % power ( @ ) to determine the primary end point using intention-to-treat analysis .


Secondary end points include parasite clearance time , rates of recurrent infection/treatment failure to day @ , gametocyte carriage throughout follow-up and rates of anaemia at day @ , as determined by survival analysis .


To assess the efficacy/safety of canagliflozin , a sodium-glucose cotransporter @ inhibitor , compared with glimepiride over @ weeks in patients with type @ diabetes inadequately controlled with metformin .


In this randomized , double-blind study , patients ( N = @,@ ) received canagliflozin @ or @ mg or glimepiride ( titrated up to @ or @ mg/day ) during a @-week core period followed by a @-week extension .


At week @ , reductions from baseline in A@C were -@ % , -@ % , and -@ % ( -@ , -@ , and -@ mmol/mol ) with canagliflozin @ and @ mg and glimepiride , respectively .


Durability analyses showed sustained A@C lowering with both canagliflozin doses versus glimepiride .


Reductions in body weight ( -@ % , -@ % , and @ % , respectively ) and systolic blood pressure ( -@ , -@ , and @ mmHg , respectively ) were seen with canagliflozin @ and @ mg compared with glimepiride at week @ .


The overall adverse event ( AE ) incidence was @ % , @ % , and @ % with canagliflozin @ and @ mg and glimepiride ; the incidence of AE-related discontinuations was low across groups ( @ % , @ % , and @ % , respectively ) .


Incidences of genital mycotic infections , urinary tract infections , and osmotic diuresis-related AEs were higher with canagliflozin than glimepiride ; these were generally mild to moderate in intensity and led to few discontinuations .


Fewer patients had hypoglycemia episodes with canagliflozin @ and @ mg than glimepiride ( @ % , @ % , and @ % ) .


Mild decreases in estimated glomerular filtration rate occurred initially with canagliflozin ; these attenuated over @ weeks .


Canagliflozin provided durable glycemic improvements compared with glimepiride and was generally well tolerated in patients with type @ diabetes receiving background treatment with metformin over @ weeks .


Catheter ablation is increasingly used to manage atrial fibrillation , but arrhythmia recurrences are common .


Adenosine might identify pulmonary veins at risk of reconnection by unmasking dormant conduction , and thereby guide additional ablation to improve arrhythmia-free survival .


We assessed whether adenosine-guided pulmonary vein isolation could prevent arrhythmia recurrence in patients undergoing radiofrequency catheter ablation for paroxysmal atrial fibrillation .


We did this randomised trial at @ hospitals in Australia , Europe , and North America .


We enrolled patients aged older than @ years who had had at least three symptomatic atrial fibrillation episodes in the past @ months , and for whom treatment with an antiarrhythmic drug failed .


After pulmonary vein isolation , intravenous adenosine was administered .


If dormant conduction was present , patients were randomly assigned ( @:@ ) to additional adenosine-guided ablation to abolish dormant conduction or to no further ablation .


If no dormant conduction was revealed , randomly selected patients were included in a registry .


Patients were masked to treatment allocation and outcomes were assessed by a masked adjudicating committee .


Patients were followed up for @ year .


The primary outcome was time to symptomatic atrial tachyarrhythmia after a single procedure in the intention-to-treat population .


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


Adenosine unmasked dormant pulmonary vein conduction in @ ( @ % ) of @ patients .


@ ( @ % ) of @ patients with additional adenosine-guided ablation were free from symptomatic atrial tachyarrhythmia compared with @ ( @ % ) of @ patients with no further ablation , corresponding to an absolute risk reduction of @ % ( @ % CI @-@ ; p < @ ) and a hazard ratio of @ ( @ % CI @-@ ; p < @ ) .


Of @ patients without dormant pulmonary vein conduction , @ ( @ % ) remained free from symptomatic atrial tachyarrhythmia ( p = @ vs dormant conduction with no further ablation ) .


Occurrences of serious adverse events were similar in each group .


One death ( massive stroke ) was deemed probably related to ablation in a patient included in the registry .


Adenosine testing to identify and target dormant pulmonary vein conduction during catheter ablation of atrial fibrillation is a safe and highly effective strategy to improve arrhythmia-free survival in patients with paroxysmal atrial fibrillation .


This approach should be considered for incorporation into routine clinical practice .


Chronic Hepatitis C ( CHC ) Virus infection is a serious health issue in the US .


Standard treatment involves peginterferon alpha and ribavirin , often associated with adverse side effects including flu-like symptoms .


These adverse effects are common reasons for the discontinuation of treatment and therefore represent a major obstacle in the effective treatment of CHC .


The Hepatitis Physical Symptom Severity Diary , a newly developed patient-reported outcome measure for assessing physical symptoms in CHC patients , was recently developed .


It contains four questions addressing flu-like symptoms -LSB- the Flu-Like Symptom Index ( FLSI ) -RSB- .


Measurement properties of the FLSI in CHC patients were assessed using data from two randomized clinical trials .


Exploratory factor analysis using data from baseline and the last visit while on treatment supported a single-factor solution for the FLSI .


Internal reliability and test-retest reliability are acceptable ( Cronbach 's alpha range @-@ @ ; intraclass correlation coefficient range @-@ @ ) , and correspondence to several similar constructs was acceptable .


The FLSI score was higher among those with investigator-reported flu-like symptoms ( mean = @ ) versus those without ( @ ) , although not statistically significant ( p = @ ) .


Responsiveness of the FLSI was moderate , as measured by standardized effect sizes and response means , and the minimum important difference ( MID ) was estimated at @-@ @ points .


While additional research should be conducted to evaluate validity with more closely related constructs and to utilize anchor-based methods for estimating the MID , data suggest that the FLSI has acceptable measurement properties and can be an effective tool in assessing flu-like symptoms in CHC patients .


Because of its location in the lower neck and anatomical variability , the C@ medial branch represents a challenging target for local anesthetic blocks .


Although ultrasound ( US ) guidance offers an alternative to fluoroscopy for C@ to C@ cervical medial branch blocks ( CMBBs ) , its use at the C@ level has not been examined .


We hypothesized that US , using a biplanar imaging technique , could provide a shorter performance time than conventional fluoroscopy for C@ CMBB .


Fifty patients undergoing C@ CMBB were randomized to fluoroscopy or US guidance .


A @-mL mixture of local anesthetic and radiographic contrast was injected in both groups .


The primary outcome was performance time .


Secondary outcomes included success rate , pain levels preblock and postblock , and incidences of aberrant spread and procedure-related complications .


Compared to fluoroscopy , US guidance was associated with a shorter performance time ( @ @ vs @ @ seconds ; P < @ ) and fewer needle passes ( @ vs @ ; P < @ ) .


However , both imaging modalities provided similar success rates ( @ % -@ % ) .


Furthermore , no intergroup differences were found in preblock and postblock pain scores .


In the fluoroscopy group , intravascular and intra-articular spreads were seen in @ % and @ % of cases , respectively .


In the US group , a blood vessel was visualized overlying the target area and successfully avoided during needle insertion in @ % of patients .


No procedure-related complications occurred in either group .


Ultrasound guidance using a biplanar approach provides a similar success rate to fluoroscopy for C@ CMBB .


However , US is associated with improved efficiency ( decreased performance time and fewer needle passes ) .


An increase in physical activity for secondary prevention of cardiovascular disease and cardiac rehabilitation has multiple therapeutic benefits , including decreased mortality .


Internet - and mobile-based interventions for physical activity have shown promising results in helping users increase or maintain their level of physical activity in general and specifically in secondary prevention of cardiovascular diseases and cardiac rehabilitation .


One component related to the efficacy of these interventions is tailoring of the content to the individual .


Our trial assessed the effect of a longitudinally tailored Internet - and mobile-based intervention for physical activity as an extension of a face-to-face cardiac rehabilitation stay .


We hypothesized that users of the tailored intervention would maintain their physical activity level better than users of the nontailored version .


The study population included adult participants of a cardiac rehabilitation program in Norway with home Internet access and a mobile phone .


The participants were randomized in monthly clusters to a tailored or nontailored ( control ) intervention group .


All participants had access to a website with information regarding cardiac rehabilitation , an online discussion forum , and an online activity calendar .


Those using the tailored intervention received tailored content based on models of health behavior via the website and mobile fully automated text messages .


The main outcome was self-reported level of physical activity , which was obtained using an online international physical activity questionnaire at baseline , at discharge , and at @ month and @ months after discharge from the cardiac rehabilitation program .


Included in the study were @ participants .


One month after discharge , the tailored intervention group ( n = @ ) had a higher median level of overall physical activity ( median @ , IQR @ ) than the control group ( n = @ , median @ , IQR @ ) , but the difference was not significant ( Kolmogorov-Smirnov Z = @ , P = @ , r = @ ) .


At @ months after discharge , the tailored intervention group ( n = @ ) had a significantly higher median level of overall physical activity ( median @ , IQR @ ) than the control group ( n = @ , median @ , IQR @ ; Kolmogorov-Smirnov Z = @ , P = @ , r = @ ) .


The median adherence was @ ( @ % CI @-@ @ ) days for the tailored group and @ ( @ % CI @-@ @ ) days for the control group ; however , the difference was not significant ( P = @ ) .


There were no statistically significant differences between the @ groups in stage of change , self-efficacy , social support , perceived tailoring , anxiety , or depression .


Because of the small sample size and the high attrition rate at the follow-up visits , we can not make conclusions regarding the efficacy of our approach , but the results indicate that the tailored version of the intervention may have contributed to the long-term higher physical activity maintained after cardiac rehabilitation by participants receiving the tailored intervention compared with those receiving the nontailored intervention .


Prospective cohort studies showed inverse associations between the intake of flavonoid-rich foods ( cocoa and tea ) and cardiovascular disease ( CVD ) .


Intervention studies showed protective effects on intermediate markers of CVD .


This may be due to the protective effects of the flavonoids epicatechin ( in cocoa and tea ) and quercetin ( in tea ) .


We investigated the effects of supplementation of pure epicatechin and quercetin on vascular function and cardiometabolic health .


Thirty-seven apparently healthy men and women aged @-@ y with a systolic blood pressure ( BP ) between @ and @ mm Hg at screening were enrolled in a randomized , double-blind , placebo-controlled , crossover trial .


CVD risk factors were measured before and after @ wk of daily flavonoid supplementation .


Participants received ( - ) - epicatechin ( @ mg/d ) , quercetin-@-glucoside ( @ mg/d ) , or placebo capsules for @ wk in random order .


The primary outcome was the change in flow-mediated dilation from pre - to postintervention .


Secondary outcomes included other markers of CVD risk and vascular function .


Epicatechin supplementation did not change flow-mediated dilation significantly ( @ % absolute ; @ % CI : -@ % , @ % ; P = @ ) .


Epicatechin supplementation improved fasting plasma insulin ( insulin : -@ mU/L ; @ % CI : -@ , -@ mU/L ; P = @ ) and insulin resistance ( homeostasis model assessment of insulin resistance : -@ ; @ % CI : -@ , -@ ; P = @ ) and had no effect on fasting plasma glucose .


Epicatechin did not change BP ( office BP and @-h ambulatory BP ) , arterial stiffness , nitric oxide , endothelin @ , or blood lipid profile .


Quercetin-@-glucoside supplementation had no effect on flow-mediated dilation , insulin resistance , or other CVD risk factors .


Our results suggest that epicatechin may in part contribute to the cardioprotective effects of cocoa and tea by improving insulin resistance .


It is unlikely that quercetin plays an important role in the cardioprotective effects of tea .


This study was registered at clinicaltrials.gov as NCT@ .


Recent evidence shows poor retention of Pediatric Advanced Life Support provider skills .


Frequent refresher training and in situ simulation are promising interventions .


We developed a `` Pediatric Advanced Life Support-reconstructed '' recertification course by deconstructing the training into six @-minute in situ simulation scenario sessions delivered over @ months .


We hypothesized that in situ Pediatric Advanced Life Support-reconstructed implementation is feasible and as effective as standard Pediatric Advanced Life Support recertification .


A prospective randomized , single-blinded trial .


Single-center , large , tertiary PICU in a university-affiliated children 's hospital .


Nurses and respiratory therapists in PICU .


Simulation-based modular Pediatric Advanced Life Support recertification training .


Simulation-based pre - and postassessment sessions were conducted to evaluate participants ' performance .


Video-recorded sessions were rated by trained raters blinded to allocation .


The primary outcome was skill performance measured by a validated Clinical Performance Tool , and secondary outcome was behavioral performance measured by a Behavioral Assessment Tool .


A mixed-effect model was used to account for baseline differences .


Forty participants were prospectively randomized to Pediatric Advanced Life Support reconstructed versus standard Pediatric Advanced Life Support with no significant difference in demographics .


Clinical Performance Tool score was similar at baseline in both groups and improved after Pediatric Advanced Life Support reconstructed ( pre , @ @ vs post , @ @ ; p < @ ) , but not after standard Pediatric Advanced Life Support ( pre , @ @ vs post , @ @ ; p = @ ) .


Improvement of Clinical Performance Tool was significantly higher in Pediatric Advanced Life Support reconstructed compared with standard Pediatric Advanced Life Support ( p = @ ) .


Behavioral Assessment Tool improved in both groups : Pediatric Advanced Life Support reconstructed ( pre , @ @ vs post , @ @ ; p = @ ) and standard Pediatric Advanced Life Support ( pre , @ @ vs post , @ @ ; p = @ ) , with no significant difference of improvement between both groups ( p = @ ) .


For PICU-based nurses and respiratory therapists , simulation-based `` Pediatric Advanced Life Support-reconstructed '' in situ training is feasible and more effective than standard Pediatric Advanced Life Support recertification training for skill performance .


Both Pediatric Advanced Life Support recertification training courses improved behavioral performance .


The safety and efficacy of tenofovir disoproxil fumarate ( TDF ) in HIV-@-infected children have not been evaluated in a randomized controlled trial .


Subjects ( @ to < @ years ) on a stavudine ( d@T ) or zidovudine ( ZDV ) containing regimen with HIV-@ RNA < @ copies/mL were randomized to either switch d@T or ZDV to TDF or continue d@T or ZDV .


The primary endpoint was the proportion of subjects with HIV-@ RNA < @ copies/mL at Week @ with a prespecified noninferiority margin of @ % .


After the @-week randomized phase , eligible subjects were rolled over to an extension phase .


Ninety-seven children ( @ TDF vs. @ d@T or ZDV ) were randomized and treated .


The percent of subjects who maintained virologic suppression in the TDF versus d@T or ZDV group at Week @ were @ % versus @ % ( difference @ % ; @ % confidence interval : : -@ % to @ % ) and at Week @ were @ % versus @ % ( difference : -@ % ; @ % confidence interval : -@ % to @ % ; missing = failure , intent-to-treat analysis ) .


No subjects discontinued study drug because of an adverse event in the @ weeks of randomized phase .


Four subjects discontinued TDF because of proximal renal tubulopathy in the extension phase .


Our study did not demonstrate noninferiority of TDF versus d@T or ZDV at Week @ .


Overall safety and tolerability of TDF in children were consistent with adults .


TDF may be considered as an alternative to d@T or ZDV in HIV-infected children .


A recent study of supermarket bakery workers in South Africa demonstrated that @ % of workers were sensitised to flour allergens and @ % had baker 's asthma .


Evidence on exposure reduction strategies using specifically designed interventions aimed at reducing the risk of baker 's asthma is scarce .


The aim of this study was to evaluate the effectiveness of different control measures to reduce airborne flour dust exposure using a randomised design .


A group-randomised study design was used to assign @ bakeries of a large supermarket chain store to two intervention groups and a control group , of which @ bakeries were studied .


Full-shift environmental personal samples were used to characterise exposure to flour dust and wheat and rye allergens levels pre-intervention ( n = @ ) and post-intervention ( n = @ ) .


The overall intervention effect revealed a @ % decrease in mean flour dust , wheat and rye allergen exposure .


The reduction in exposure was highest for managers ( @ % ) and bakers ( @ % ) , and lowest for counterhands ( @ % ) .


For bakers , the greatest reduction in flour dust was associated with control measures such as the use of the mixer lid ( @ % ) , divider oil ( @ % ) or focused training ( @ % ) .


However , the greatest reduction ( @ % ) was observed when using a combination of all control measures .


A specially designed intervention strategy reduced both flour dust and allergen levels .


Best results were observed when combining both engineering controls and training .


Further studies will investigate the long-term health impact of these interventions on reducing the disease burden among this group of bakers .


Depression is common after acute coronary syndrome ( ACS ) and has adverse effects on prognosis .


There are few evidence-based interventions for treating depression in ACS .


This study investigated the efficacy and safety of escitalopram in treating depressive disorders identified @-@ weeks after a confirmed ACS episode .


A total of @ patients with DSM-IV depressive disorders ( @ major and @ minor ) and ACS were randomly assigned to receive escitalopram in flexible doses of @-@ mg/d ( n = @ ) or placebo ( n = @ ) for @ weeks .


The study was conducted from @ to @ .


The primary outcome measure was the Hamilton Depression Rating Scale ( HDRS ) .


Secondary outcome measures included the Montgomery-Asberg Depression Rating Scale ( MADRS ) , Beck Depression Inventory ( BDI ) , Clinical Global Impressions-Severity of Illness scale ( CGI-S ) , Social and Occupational Functioning Assessment Scale ( SOFAS ) , and World Health Organization Disability Assessment Schedule-@ .


Cardiovascular safety outcomes included echocardiography , electrocardiography , laboratory test , body weight , and blood pressure results .


Escitalopram was superior to placebo in reducing HDRS scores ( mean difference = @ , P = @ , effect size = @ ) .


Escitalopram was also superior to placebo in decreasing depressive symptoms evaluated by the MADRS , BDI , and CGI-S and in improving SOFAS functioning level .


Escitalopram was not associated with any harmful changes in cardiovascular safety measures .


Dizziness was significantly more frequently reported in the escitalopram group ( P = @ ) , but there were no significant differences in any other adverse events .


These results indicate that escitalopram has clinically meaningful antidepressant effects with no evidence of reduced cardiovascular safety in depressive disorder following ACS .


In ablation of atrial fibrillation , the single-ring method aims for isolation of the posterior wall of the left atrium ( LA ) including the pulmonary veins ( PVs ) but avoiding posterior LA lesions .


The aim of this randomized prospective study was to evaluate safety and efficacy of remote magnetic navigation ( RMN ) - guided single-ring ablation strategy as compared to standard RMN-guided circumferential PV ablation ( PVA ) .


Eighty consecutive patients undergoing PVA were enrolled prospectively and randomized equally into two study groups .


RMN using the Stereotaxis system and open-irrigated @-mm ablation catheters were used with a @D mapping system in all procedures .


Forty patients underwent RMN-guided single-ring ablation , and @ patients received RMN-guided circumferential PVA .


In the circumferential group , @ @ PVs were successfully isolated at the end of the procedure as compared to @ @ in the single-ring ( box ) group ( p = @ ) .


All patients in the box group required additional posterior lesions in order to achieve electrical isolation of the PVs .


Single-ring ablation was associated with longer procedure duration ( p = @ ) and ablation time ( p = @ ) .


After a single procedure , the proportion of patients free of any atrial tachycardia ( AT ) / atrial fibrillation ( AF ) episode at @-month follow-up was @ % in the box group and @ % in the circ group .


Using RMN , only minor complications have been observed .


RMN-guided single-ring PVA provides comparable acute and long-term success rates as compared to RMN-guided circumferential PVA but requires additional posterior lesions to achieve PV isolation and increased procedure and ablation time .


Procedural complication rates are low when using RMN .


This study investigated the effects and Numerical Rating Pain Scale ( NRS ) of using absorbable shanching satin rb-bFGF prepreg sheet and expansion hemostatic sponge together nasal packing in the control of epistaxis with blood disease , and compared it with traditional vaseline gauze .


Ninety-six blood disease patient with epistaxis were enrolled between January @ and February @ , they were divided into two groups at random , and differently treated with absorbable shanching satin rb-bFGF prepreg sheet and the vaseline gauze nasal packing for haemostasis .


Then haemostasis efficacy , the hemorrhage rate after nasal packing removed and host response , such as nasal pain and headache , which evaluated pain degrees against NRS , were all observed .


There was no significant difference between the two groups of the haemostatic effect .


But the hemorrhage rate of treatment group was obviously lower than that of the control group after paching , in addition , host responses , such as nasal pain and headache , remarkably better than the control group , the difference had statistical significance .


It is indicate that absorbable shanching satin rb-bFGF prepreg sheet presents reliable hemostasis effect , good biocompatibility and compliance ; the pain and headache caused by packing are superior to vaseline gauze .


Moreover , this method avoids the direct touch of vaseline gauze with nasal mucosal wound , and reduce hemorrhage after packing .


Absorbable shanching satin rb-bFGF prepreg sheet and expansion hemostatic sponge together is better to select the nasal packing material for blood disease patient with epistaxis .


The purpose of this study was to assess long-term improvement in quality of life ( QOL ) in adolescents with attention-deficit/hyperactivity disorder ( ADHD ) treated with lisdexamfetamine dimesylate ( LDX ) .


Adolescents with ADHD treated for @ weeks in a @ week , placebo-controlled study entered a @ year , open-label study .


After the @ week dose optimization ( @ , @ , and @mg/day LDX ) period , treatment was maintained for @ additional weeks .


Change from baseline ( of prior study ) to week @/early termination ( ET ) ( of open-label study ) in ADHD Rating Scale IV ( ADHD-RS-IV ) assessed effectiveness , and the Youth QOL-Research Version ( YQOL-R ) assessed participant-perceived QOL .


Post-hoc analyses described effectiveness and QOL for participants with self-perceived poor QOL at baseline ( @ SD below the mean ) versus all others , and for study completers versus study noncompleters .


These post-hoc analyses included @ participants .


Participants with baseline self-perceived poor QOL ( n = @ ) versus all others ( n = @ ) exhibited robust YQOL-R perceptual score changes ( improvement ) with LDX , emerging by week @ and maintained to week @/ET .


Week @/ET mean change score ranged from +@ to +@ for participants with baseline self-perceived poor QOL and +@ to +@ for all others ; week @/ET improvements in ADHD-RS-IV total scores were similar , regardless of baseline YQOL-R total score .


At week @/ET , study completers had greater YQOL-R improvements than did noncompleters ; ADHD-RS-IV total score changes were also numerically larger at week @/ET for completers than for noncompleters .


Participant-perceived QOL and ADHD symptoms improved from baseline with LDX in adolescents with ADHD ; greatest improvements occurred among participants with baseline self-perceived poor QOL .


Chemotherapy-induced peripheral neuropathy ( CIPN ) , a common side effect of chemotherapy , needs better effective treatments .


Preliminary data support the use of Scrambler therapy , a device which treats pain via noninvasive cutaneous electrostimulation , for the treatment of CIPN .


The current manuscript reports data from a pilot trial , performed to investigate the effect of Scrambler therapy for the treatment of established CIPN .


Eligible patients had CIPN symptoms of @ month duration with tingling and/or pain @/@ during the prior week .


Patients were treated with Scrambler therapy to the affected area ( s ) for up to ten daily @-min sessions .


Symptoms were monitored using a neuropathy questionnaire consisting of numerical analog scales ranging from @ to @ , daily before therapy as well as weekly for @ weeks after therapy .


Descriptive summary statistics formed the basis of data analysis .


Thirty-seven patients were enrolled .


Twenty-five patients were treated primarily on their lower extremities while @ were treated primarily on their upper extremities .


There was a @ % reduction in pain score from baseline to day @ ; a @ % reduction in tingling ; and a @ % reduction in numbness .


Benefit appeared to last throughout @ weeks of follow-up .


There were no substantial adverse events .


Preliminary data support that Scrambler therapy may be effective for the treatment of CIPN : a prospective placebo-controlled clinical trial should be performed .


The treatment of burn patients who undergo mechanical ventilation is complicated by many factors ; patient outcomes and mortality could potentially be improved with predictive biomarkers .


Severe burn provokes a systemic inflammatory response characterized by the release of a host of cytokines .


Recent studies evaluated the prognostic value of temporal changes in cytokine levels in several patient populations , but few have compared differences in the cytokine profiles of survivors and nonsurvivors following severe burn .


We previously compared high-frequency percussive ventilation and low-tidal-volume ventilation and found no difference in mortality or cytokine levels between the two treatments .


Since it is unknown whether cytokine levels are predictive of mortality in these patients , we performed a post hoc analysis comparing cytokine levels in survivors and nonsurvivors .


We evaluated plasma levels of several cytokines ( interleukin @ -LSB- IL-@ -RSB- , IL-@ , IL-@ , granulocyte-macrophage colony-stimulating factor , and tumor necrosis factor ) for their prognostic biomarker potential related to mortality at @ , @ , and @ days in survivors and nonsurvivors of burns .


While the majority of values for IL-@ , granulocyte-macrophage colony-stimulating factor , and tumor necrosis factor fell below the limit of quantification , univariate analysis demonstrated higher plasma levels of IL-@ and IL-@ in nonsurvivors on Day @ .


Logistic regression revealed that elevated plasma IL-@ was independently associated with an increased likelihood of the composite end point of death or ventilator-associated pneumonia with odds ratios of @ , @ , and @ on Days @ , @ , and @ , respectively .


Early increases in plasma IL-@ are associated with a multifold increase in death or ventilator-associated pneumonia in mechanically ventilated burn patients .


Prognostic/epidemiologic study , level IV ; therapeutic study , level IV .


The purpose of this report was to examine the course of smoking among pregnant women with concurrent substance use , and to assess the impact of depression on smoking .


Data were gathered as part of a randomized controlled trial assessing the efficacy of substance abuse treatment in pregnant women .


Women ( n = @ ) were recruited before @ completed weeks of pregnancy , and followed until @months postpartum .


Depression was assessed using the Inventory of Depressive Symptomatology and the MINI Neuropsychiatric Interview .


Our outcome was the average number of cigarettes smoked per day .


Linear mixed effects regression was used to measure differential changes in smoking .


@ % of women smoked in the three months before pregnancy , @ % of pre-pregnancy smokers achieved abstinence before delivery and @ % of the baseline cohort smoked postpartum .


Smoking did not differ significantly between depressed and non-depressed groups .


After delivery both groups increased smoking at similar rates .


Smoking was common among our cohort of pregnant women with a history of substance use .


Women were able to discontinue or decrease smoking during pregnancy , but were likely to resume or increase smoking postpartum .


Having clinically significant depressive symptoms or a diagnosis of depression did not have an obvious effect on smoking behaviors .


To assess effects of tadalafil vs placebo on prostatic blood flow measured by transrectal ultrasonography in men aged@years with moderate-to-severe benign prostatic hyperplasia-lower urinary tract symptoms .


After screening and washout , patients were randomized to placebo ( n = @ ) or tadalafil @mg ( n = @ ) once daily for @weeks .


Transrectal ultrasonography was performed at baseline , @ , and @weeks .


The primary efficacy measure was the prostate transition zone ( TZ ) resistive index ( RI ) .


Secondary efficacy measures were RI in the peripheral zone and bladder neck , color pixel intensity ( CPI ) , and color pixel density ( CPD ) in all @ regions .


Outcomes were assessed using mixed-model repeated-measures analyses .


The overall treatment effect ( tadalafil vs placebo ) for the change from baseline through week @ in prostate TZ RI was not statistically significant ( least squares mean change : placebo,-@ @ ; tadalafil , @ ; P = @ ) , nor was the change from baseline in prostate TZ CPI ( P = @ ) or CPD ( P = @ ) .


Results were similar for all flow measures in prostate peripheral zone and bladder neck .


The adverse event profile was consistent with previous studies with no new safety findings .


Tadalafil for @weeks in men with BPH-LUTS did not result in detectable decreases in arterial RI or increases in CPI or CPD in the prostate or bladder neck .


Detection of changes may not be possible because of already low baseline RI , insufficient sensitivity of techniques used , or may have been confounded by methodologic variability across sites .


Alternatively , other possible mechanisms not assessed in this study may be more prominently involved .


Although the repositioning maneuvers are usually very effective in patients with BPPV , some patients still complain residual dizziness .


Danhong injection ( DHI ) , a traditional Chinese medicine , can effectively dilate blood vessels and improve microcirculation , and has been proven to be effective in improving cervical vertigo and posterior circulation ischemic vertigo .


The aim of this study was to evaluate the effects of DHI on residual dizziness after successful repositioning treatment in patients with BPPV .


Eighty-six patients with BPPV were randomized into two treatment groups , DHI group and non DHI group .


The DHI group received the same repositioning treatment as the non-DHI group , with the addition of DHI therapy .


The durations of residual dizziness of DHI group and non-DHI group were compared .


In addition , the scores of the dizziness handicap inventory of these two groups were calculated .


The durations of residual dizziness of DHI group were shorter than that of non-DHI group .


There were no significant differences in the scores of dizziness handicap inventory in the first week between these two groups , and there were much significant differences in the second , the fourth , the sixth and eighth weeks .


The results demonstrate that DHI can significantly improve the residual dizziness after successful repositioning treatment in patients with BPPV .


Syphilis infection may potentiate transmission of human immunodeficiency virus ( HIV ) .


We sought to determine the extent to which HIV acquisition was associated with syphilis infection within an HIV preexposure prophylaxis ( PrEP ) trial and whether emtricitabine/tenofovir ( FTC/TDF ) modified that association .


The Preexposure Prophylaxis Initiative ( iPrEx ) study randomly assigned @ HIV-seronegative men and transgender women who have sex with men ( MSM ) to receive oral daily FTC/TDF or placebo .


Syphilis prevalence at screening and incidence during follow-up were measured .


Hazard ratios for the effect of incident syphilis on HIV acquisition were calculated .


The effect of FTC/TDF on incident syphilis and HIV acquisition was assessed .


Of @ individuals , @ ( @ % ) had a positive rapid plasma reagin test at screening ; @ ( @ % ) had a positive confirmatory test , which did not differ between the arms ( FTC/TDF vs placebo , P = @ ) .


The overall syphilis incidence during the trial was @ cases per @ person-years .


There was no difference in syphilis incidence between the study arms ( @ cases per @ person-years for FTC/TDF vs @ cases per @ person-years for placebo , P = @ ) .


HIV incidence varied by incident syphilis ( @ cases per @ person-years for no syphilis vs @ cases per @ person-years for incident syphilis ) , reflecting a hazard ratio of @ ( @ % confidence interval , @-@ @ ; P < @ ) .


There was no evidence for interaction between randomization to the FTC/TDF arm and incident syphilis on HIV incidence .


In HIV-seronegative MSM , syphilis infection was associated with HIV acquisition in this PrEP trial ; a syphilis diagnosis should prompt providers to offer PrEP unless otherwise contraindicated .


To test the effectiveness and safety of saxagliptin @ mg/d in patients with type @ diabetes mellitus ( T@DM ) with and without history of cardiovascular disease ( CVD ) or cardiovascular ( CV ) risk factors .


The authors conducted a post hoc analysis of data from @ randomized studies that compared saxagliptin versus placebo as initial combination therapy with metformin for @ weeks ( N = @ ) and versus placebo as an add-on to insulin with and without metformin for @ weeks ( N = @ ) , and assessed noninferiority to glipizide as an add-on to metformin for @ weeks ( N = @ ) .


Efficacy outcomes were the adjusted mean change from baseline in glycated hemoglobin ( HbA@c ) level , fasting plasma glucose concentration , and body weight and the proportion of patients achieving an HbA@c level < @ % .


Pairwise comparisons were performed in subgroups with @ ) history/no history of CVD , @ ) @ versus @ to @ CV risk factors , @ ) hypertension/no hypertension , and @ ) statin use/no statin use .


Adverse events ( AE ) and hypoglycemia were monitored .


In the initial combination therapy study , reductions in HbA@c level from baseline were greater with saxagliptin versus placebo in all subgroups ( difference -LSB- saxagliptin - placebo -RSB- , -@ % to -@ % ) .


In the add-on to insulin metformin study , differences in adjusted mean change in HbA@c level versus placebo ranged from -@ % to -@ % across subgroups .


In the noninferiority to glipizide study , adjusted mean changes in HbA@c level were comparable between saxagliptin and glipizide , across subgroups ( difference , @ % -@ % ) .


No evidence suggested clinically relevant treatment-by-subgroup interactions in pairwise comparison .


Incidences of @ AE were comparable across subgroups .


Incidences of confirmed hypoglycemia with saxagliptin were @ in both metformin add-on studies and @ % to @ % with saxagliptin + insulin metformin .


In patients with T@DM , saxagliptin @ mg/d was similarly effective in improving glycemic control , with an AE profile similar to that of placebo , irrespective of CVD history , number of CV risk factors , hypertension , or statin use .


Cervical incompetence is one of the causes of preterm birth and mid-trimester pregnancy loss .


Cervical cerclage is a surgical procedure to treat cervical incompetence .


Cervical cerclage reduces the incidence of preterm birth in women at risk of recurrent preterm birth , without a statistically significant reduction in perinatal mortality or neonatal morbidity .


Multifilament/braided sutures such as Mersilene tape have been traditionally used for cervical cerclage .


Braided sutures , particularly mesh-like non-absorbable sutures , have been associated with an increased risk of infection and , hence , some obstetricians prefer to use monofilament/non-braided sutures .


However , these claims are not substantiated by any scientific or clinical evidence.We propose a pilot/feasibility study which will provide the necessary information for planning a definitive trial investigating the clinical effectiveness of monofilament non-braided suture materials in reducing pregnancy loss rate following cervical cerclage compared to the traditional multifilament braided sutures .


Women eligible for elective or ultrasound-indicated cerclage at @ to @ + @ weeks of gestation will be randomised to having the procedure using either a monofilament non-braided suture ( Ethilon ) or a Multifilament braided suture ( Mersilene tape ) inserted using a McDonald technique .


Consent for participation in the Cerclage outcome by the type of suture ( COTS ) study will be obtained from each eligible participant .


Our objective was to evaluate effects of levothyroxine ( l-T@ ) supplementation against neurodevelopmental outcomes at @ months of corrected age in very-low-birth-weight ( VLBW ) infants with hypothyroxinemia but without elevated thyroid-stimulating hormone ( TSH ) concentration .


VLBW infants who had plasma TSH concentrations < @ U/mL and free thyroxine ( FT@ ) concentrations < @ ng/dL between @ and @ weeks of age were enrolled .


They were randomly assigned to either the Treated ( n = @ ) or Untreated group ( n = @ ) .


The Treated group received l-T@ at a dose of @ g/kg/day .


We compared growth and neurodevelopmental outcomes at @ months of corrected age in the two groups .


There were no significant differences in growth , the incidences of developmental delay , cerebral palsy , visual impairment , and hearing impairment in the two groups .


In such infants , l-T@ supplementation at a dose of @ g/kg/day did not affect FT@ levels and showed no beneficial effect at @ months of corrected age .


Consultations for forefoot pain are frequent in primary care , but scientific support of treatment options is scarce .


The purpose of this study is to investigate the effect of podiatric treatment vs standardized advice on proper shoe characteristics and fit of shoes by means of an information leaflet for people aged @ years and older with forefoot pain in primary care .


In this randomized controlled trial , @ participants aged @ years and older with hindering nontraumatic forefoot pain have been recruited at their general practitioner 's office .


Exclusion criteria were treatment of forefoot problem of less than @ months ' duration before inclusion , rheumatoid arthritis , and diabetic neuropathy or having pain considered not to be musculoskeletal ( eg , warts ) .


Participants received shoe advice by means of an information leaflet or podiatric care .


Foot pain , foot-related dysfunction , general health , and social participation were assessed by means of questionnaires every @ months for @ year .


Using multilevel analysis , we analyzed results at the level of ( @ ) outcome measures , ( @ ) the individual , and ( @ ) the general practitioner .


No differences were found between the @ treatment groups .


Both intervention groups showed an improvement over time in foot pain and foot-related dysfunction .


This study found that shoe advice provided to patients consulting their general practitioner for forefoot pain and symptom relief resulted in outcomes similar to treatment outcomes in patients consulting a podiatrist .


Based on these results , primary care physicians should be cautious when referring a patient to a podiatrist ; instead , they should start by providing advice on proper characteristics and fit of shoes .


The aim of this randomized controlled trial was to investigate the effects of conventional face-to-face group cognitive behavioral therapy ( GCBT ) and an Internet-delivered guided self-help treatment ( Internet-based CBT , ICBT ) on tinnitus distress .


A total of @ adults with at least mild levels of chronic tinnitus distress were randomly assigned to GCBT ( n = @ ) , ICBT ( n = @ ) , or a web-based discussion forum ( DF ) that served as a control condition ( n = @ ) .


Standardized self-report measures -LSB- the Tinnitus Handicap Inventory ( THI ) , Mini-Tinnitus Questionnaire ( Mini-TQ ) , Hospital Anxiety and Depression Scale , Insomnia Severity Index and Tinnitus Acceptance Questionnaire -RSB- were completed at the pre - and post-assessments and at the @-month follow-up .


Repeated-measures ANOVAs revealed significant time group interaction effects on the primary outcomes ( THI and Mini-TQ scores ) in favor of both CBT interventions compared with the DF at post-assessment ( @ g @ ; all p @ ) .


There were no significant differences between GCBT and ICBT ( all p > @ ) and the treatment effects remained stable at the @-month follow-up .


This study provides evidence that ICBT might be an equally effective alternative to conventional CBT in the management of chronic tinnitus .


Despite encouraging results , further research is necessary to determine the actual potential of ICBT as a viable alternative to CBT , and under which circumstances it is effective .


To investigate the effect of thorascopic administration.of ginseng polysaccharides ( GPS ) plus dendritic cells ( DC ) on T helper cell type @/T helper cell type @ ( Th@/Th@ ) balance in patients with non-small cell lung cancer ( NSCLC ) .


A total of @ NSCLC patients were divided evenly into two groups .


The control group was treated with DCs alone and the treatment group was treated with DCs plus GPS .


After DCs and GPS were administered thoracoscopically , once a week , @ times for @ days , the patients ' quality of life was measured with the Functional Assessment of Cancer Treatment-Lung ( FACT-L ) questionnaire before and after treatment .


Serum interferon - ( INF - ) , interleukin-@ ( IL-@ ) , IL-@ and IL-@ were examined before and after treatments .


The level of Th@ cytokines ( INF - , IL-@ ) and the ratio of Th@/Th@ cytokines ( INF - / IL-@ , IL-@ / IL-@ ) increased in both treatment groups , while Th@ cytokines ( IL-@ , IL-@ ) and FACT-L scores decreased ( P < @ ) .


Furthermore , after treatment Th@ cytokines ( INF - , IL-@ ) and the ratio of Th@/Th@ cytokines ( INF - / IL-@ , IL-@ / IL-@ ) were higher in the DCs + GPS group than in the control group ( P < @ ) .


Conversely , FACT-L scores and Th@ cytokines ( IL-@ , IL-@ ) were higher in the control group than in the DCs + GPS group ( P < @ ) .


The treatment regime of DCs plus GPS had a greater effect on NSCLC patients ' immune function as compared with DCs alone .


This was evident by increased expression of Th@ cytokines ( INF - , IL-@ ) and the ratio of Th@/Th@ ( INF - / IL-@ , IL-@ / IL-@ ) , as well as by decreased FACT-L scores and the expression of Th@ cytokines ( IL-@ , IL-@ ) .


Based on results of the PLATO ( Platelet Inhibition and Patient Outcomes ) trial comparing ticagrelor with clopidogrel therapy , the U.S. Food and Drug Administration approved ticagrelor in @ for reducing thrombotic cardiovascular events in patients with acute coronary syndrome ( ACS ) with the proviso that it be taken with low-dose aspirin .


This study sought to assess the cost and cost effectiveness of ticagrelor therapy relative to clopidogrel in treating ACS patients from the perspective of the U.S. health care system .


We estimated within-trial resource use and costs using U.S. low-dose aspirin patients in PLATO ( n = @ ) .


Quality-adjusted life expectancy was estimated using the total PLATO population ( n = @,@ ) , combined with baseline risk and long-term survival data from an external ACS patient cohort .


Study drugs were valued at current costs .


Cost effectiveness was assessed , as was the sensitivity of results to sampling and methodological uncertainties .


One year of ticagrelor therapy , relative to that of generic clopidogrel , cost $ @,@ / quality-adjusted life-year gained , with @ % of bootstrap estimates falling under a $ @,@ willingness-to-pay threshold .


Results were robust to extensive sensitivity analyses , including variations in clopidogrel cost , exclusion of costs in extended years of life , and a recalibrated estimate of survival reflecting a lower underlying mortality risk in the United States .


For PLATO-eligible ACS patients , a U.S. perspective comparison of the current standard of dual antiplatelet therapy of aspirin with clopidogrel versus aspirin plus ticagrelor showed that the ticagrelor regimen increased life expectancy at an incremental cost well within accepted benchmarks of good value for money .


( A Comparison of Ticagrelor -LSB- AZD@ -RSB- and Clopidogrel in Patients With Acute Coronary Syndrome -LSB- PLATO -RSB- ; NCT@ ) .


Mipomersen , an apolipoprotein B synthesis inhibitor , demonstrated significant reductions in low-density lipoprotein ( LDL ) cholesterol , non-high density lipoprotein cholesterol , and apolipoprotein B in @ phase @ studies at the FDA-approved subcutaneous dose of @ mg once weekly .


A short-term phase @ study in healthy volunteers was conducted to evaluate the relative bioavailability , safety , and tolerability of mipomersen in @ test dose regimens in reference to the @ mg weekly dose regimen .


Eighty-four adults were randomized to @ of @ cohorts ( @ mg once daily , @ mg @ times weekly , or @ mg once weekly ) and then mipomersen or placebo ( @:@ ratio ) for @ weeks of treatment .


Comparable mipomersen post-distribution phase plasma concentrations were observed across the @ dose regimens suggesting similar tissue exposure .


Injection site reactions were reported , but did not lead to treatment discontinuation .


The median incidence of these responses per injection was decreased by lowering the dose .


Signals from a diverse panel of systemic inflammation markers were essentially indistinguishable between dose regimens and placebo treatment .


The one exception was a modest transient post-dose elevation of C-reactive protein ( CRP ) in the mipomersen @ mg weekly group .


This elevation was not associated with an increase in other proinflammatory markers .


This study demonstrated a similar drug exposure and overall safety profile between the @ dosing regimens .


Exploratory assessment of a diverse panel of biomarkers found no indication of a systemic inflammatory response to mipomersen treatment .


These results support assessment of alternative dose regimens in longer-term studies .


There is disagreement regarding the performance of conventional optical microscopy to assess the origin of hematuria .


The aim of this study was to determine the optimal cutoff point for dysmorphic cells in order to detect glomerular hematuria by optical and phase-contrast microscopy .


In total , @ urine samples ( @ from patients with glomerulopathies and @ from nephrolithiasis patients ) were evaluated in a blinded fashion .


The percentages of doughnut cells and acanthocytes were verified by optical and phase-contrast microscopy .


A total of @ patients were randomly allocated to the derivation ( n = @ ) and validation ( n = @ ) groups .


Receiver-operating characteristic ( ROC ) curves were plotted to check the discriminatory power of each group and the best cutoff points were determined by the Youden index in the derivation group and subsequently tested in the validation group .


All areas under the ROC curve ( AUCs ) were statistically significant using both methods ( conventional optical and phase-contrast microscopy ) and both groups ( derivation and validation ) .


AUCs did not differ between different glomerulopathies .


The best cutoff point to determine the glomerular origin of hematuria by total dysmorphic cells was @ % using an optical conventional microscope and @ % by phase-contrast microscopy .


We determined the best cutoff points to interpret erythrocyte dysmorphism and demonstrated that it is possible to discriminate the origin of hematuria by evaluating erythrocyte dysmorphism in urinalysis using either an optical or a phase-contrast microscope .


Many physicians consider platinum-doublet chemotherapy inappropriate for elderly patients , regardless of their medical fitness .


This was a retrospective subgroup analysis of data from a multicenter , randomized , phase III clinical trial evaluating pemetrexed + carboplatin versus docetaxel + carboplatin in elderly chemo-naive patients with advanced , nonsquamous non-small cell lung cancer ( NSCLC ) .


Data from elderly patients ( aged @ years and @ years ) were evaluated using the same statistical methods as those used in patients aged < @ years and qualified intent-to-treat ( Q-ITT ) populations .


The primary objective of the clinical trial was comparison of pemetrexed + carboplatin with docetaxel + carboplatin in terms of survival without grade @ or @ toxicity in chemo-naive NSCLC patients .


The @ - and @-year age groups had @ and @ patients , respectively .


Among patients aged @ years , the adjusted hazard ratio ( HR ) for survival without grade @-@ toxicity ( HR @ , @ % confidence interval -LSB- CI -RSB- @-@ @ ) favored pemetrexed + carboplatin ; this was similar to the HRs in patients aged @ years ( HR @ , @ % CI @-@ @ ) , patients aged < @ years ( HR @ , @ % CI @-@ @ ) , and the Q-ITT population ( HR @ , @ % CI @-@ @ ) .


The median values for overall survival ( OS ) and progression-free survival ( PFS ) were similar across all age-group subsets and the Q-ITT population .


The HRs for OS and PFS were similar for all age-group subsets , except for the @-year age group , which favored pemetrexed + carboplatin to a greater extent .


The toxicity profile was similar across age groups , with the exception of diarrhea , mucosal inflammation , and grade @-@ neutropenia and leukopenia , which were slightly more common in elderly patients in both treatment arms .


Between-arm differences in the toxicity profiles for the @ - , @ - and < @-year age subgroups were similar to those in the Q-ITT population .


There were no on-study deaths or unexpected toxicities .


The benefits of pemetrexed + carboplatin were maintained , and toxicity was manageable in both elderly subgroups .


The favorable risk-benefit profile of pemetrexed + carboplatin makes it an appropriate first-line treatment option for elderly patients with advanced nonsquamous NSCLC .


Fiscal strategies are increasingly considered upstream nutrition promotion measures .


However , few trials have investigated the effectiveness or cost effectiveness of pricing manipulations on diet in real-world settings .


We assessed the effects on fruit , vegetable , and beverage purchasing and consumption of a @ % price-reduction intervention , a tailored skills-based behavior-change intervention , and a combined intervention compared with a control condition .


The Supermarket Healthy Eating for Life trial was a randomized controlled trial conducted over @ mo -LSB- baseline ( time @ ) to postintervention ( time @ ) with a @-mo follow-up ( time @ ) -RSB- .


Female primary household shoppers in Melbourne , Australia , were randomly assigned to a @ ) skill-building ( n = @ ) , @ ) price-reduction ( n = @ ) , @ ) combined skill-building and price-reduction ( n = @ ) , or @ ) control ( n = @ ) group .


Supermarket transaction data and surveys were used to measure the following study outcomes : fruit , vegetable , and beverage purchases and self-reported fruit and vegetable consumption at each time point .


At @ mo ( time @ ) , price reduction-alone participants purchased more total vegetables and frozen vegetables than did controls .


Price reduction-alone and price reduction-plus-skill-building participants purchased more fruit than did controls .


Relative to controls , in the price-reduction group , total vegetable consumption increased by @ g/wk ( @ servings or @ % more than at baseline ) , and fruit purchases increased by @ g/wk ( @ servings ; @ % more than at baseline ) .


Increases were not maintained @ mo postintervention ( time @ ) .


Price reduction-alone participants showed a tendency for a slight increase in fruit consumption at time @ ( P = @ ) that was maintained at time @ ( P = @ ) .


No intervention improved purchases of bottled water or low-calorie beverages .


A @ % price reduction in fruit and vegetables resulted in increased purchasing per household of @ % for fruit and @ % for vegetables over the price-reduction period .


These findings show that price modifications can directly increase produce purchases .


The Supermarket Healthy Eating for Life trial was registered at Current Controlled Trials Registration as ISRCTN@ .


C@q/TNF-Related Protein ( CTRP ) family members are novel adipokines that have anti-inflammatory , immunomodulatory , glucose-regulating and vascular effects .


However , the metabolic effects of CTRP@ remain unclear in humans .


The aims of this study were to investigate whether serum CTRP@ concentrations are associated with glucose tolerance , metabolic parameters and abdominal fat accumulation .


In addition , the authors investigated whether the aforementioned effects of CTRP@ are independent of serum adiponectin levels .


A total of @ subjects ( @ men and @ women ) , @-@ years of age ( mean age @ years ) , were randomly selected from two different study populations .


The normal glucose tolerance group ( n = @ ) was selected from one study population and the prediabetes/type @ diabetes group ( n = @ ) was selected from the other study population .


Serum CTRP@ , total adiponectin concentrations and abdominal fat via computed tomography scan were measured in all subjects .


Subjects in the lower serum CTRP@ tertile were older , had metabolically unhealthy profiles and had lower serum total adiponectin levels when compared with subjects in the middle or upper serum CTRP@ tertiles .


In addition , serum CTRP@ concentration were inversely correlated with age , blood pressure , fasting glucose , homeostasis model assessment for insulin resistance , total cholesterol , triglyceride and low-density lipoprotein cholesterol levels ( all P < @ ) and positively correlated with serum total adiponectin levels ( P = @ ) .


In terms of abdominal fat accumulation , serum CTRP@ concentrations were inversely correlated with visceral fat amount ( P < @ ) , but no correlation was observed with subcutaneous fat amount .


Finally , serum CTRP@ was inversely associated with the presence of metabolic syndrome , independent of age , sex , body mass index , smoking status , total cholesterol , visceral fat and serum total adiponectin concentrations ( odds ratio per @ s.d. @ ; @ % confidence interval @-@ @ ; P < @ ) .


Serum CTRP@ concentrations were positively associated with favorable glucose or metabolic phenotypes and absence of metabolic syndrome , independent of serum total adiponectin concentrations .


Skeletal muscle impairment is a recognized complication of COPD , predicting mortality in severe disease .


Increasing evidence implicates the renin-angiotensin system in control of muscle phenotype .


We hypothesized that angiotensin-converting enzyme ( ACE ) inhibition would improve quadriceps function and exercise performance in COPD .


This double-blind , randomized placebo-controlled trial investigated the effect of the ACE inhibitor , fosinopril , on quadriceps function in patients with COPD with quadriceps weakness .


Primary outcomes were change in quadriceps endurance and atrophy signaling at @ months .


Quadriceps maximum voluntary contraction ( QMVC ) , mid-thigh CT scan of the cross-sectional area ( MTCSA ) , and incremental shuttle walk distance ( ISWD ) were secondary outcomes .


Eighty patients were enrolled ( mean -LSB- SD -RSB- , @ -LSB- @ -RSB- years , FEV@ @ % -LSB- @ % -RSB- predicted , @ % men ) .


Sixty-seven patients ( @ fosinopril , @ placebo ) completed the trial .


The treatment group demonstrated a significant reduction in systolic BP ( -@ mm Hg ; @ % CI , -@ to -@ ; P = @ ) and serum ACE activity ( -@ IU/L ; @ % CI , -@ to -@ ; P < @ ) compared with placebo .


No significant between-group differences were observed in the primary end points of quadriceps endurance half-time ( @ s ; @ % CI , -@ -@ ; P = @ ) or atrogin-@ messenger RNA expression ( -@ arbitrary units ; @ % CI , -@ -@ ; P = @ ) .


QMVC improved in both groups ( fosinopril : @ kg ; @ % CI , @-@ @ ; P = @ vs placebo : @ kg ; @ % CI , @-@ @ ; P < @ ) with a greater increase in the placebo arm ( between-group , P = @ ) .


No change was shown in the MTCSA ( P = @ ) or ISWD ( P = @ ) .


This randomized controlled trial found that ACE inhibition , using fosinopril for @ months , did not improve quadriceps function or exercise performance in patients with COPD with quadriceps weakness .


The LUME-Lung @ trial ( NCT@ ; Study @ ) demonstrated a significant overall survival ( OS ) advantage for nintedanib plus docetaxel compared with placebo plus docetaxel as second-line therapy for patients with advanced non-small cell lung cancer ( NSCLC ) and adenocarcinoma histology .


Patient-reported outcomes ( PROs ) for symptoms and health-related quality of life ( QoL ) are reported here .


PROs were assessed at screening , on Day @ of each @-day treatment cycle , at the end of active treatment , and at the first follow-up visit .


PRO instruments were the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C@ and Lung Cancer-@ supplement , and the EuroQol disease-generic questionnaire ( EQ-@D and EQ-VAS ) .


Analyses of PRO items for lung cancer-specific symptoms of cough , dyspnoea and pain were prespecified .


Rates of questionnaire completion were high .


There was no significant difference in time to deterioration of global health status/QoL , or symptoms of cough , dyspnoea or pain , between the treatment groups for both the overall study population and the adenocarcinoma population .


Time to deterioration of some gastrointestinal events was shorter with nintedanib versus placebo .


Longitudinal analysis for the adenocarcinoma population showed comparable changes between the groups in symptom scores over time , with numerical differences in favour of nintedanib for cough and pain scales , and significant reductions in some pain items with nintedanib versus placebo .


There was no statistically significant difference in EQ-@D or EQ-VAS between the groups .


The significant OS benefit observed with the addition of nintedanib to docetaxel therapy was achieved with no detrimental effect on patient self-reported QoL .


Kakkonto , a Japanese herbal medicine , is frequently used to treat the common cold not only with a physician 's prescription , but also in self-medication situations .


This study aimed to examine whether Kakkonto prevents the aggravation of cold symptoms if taken at an early stage of illness compared with a well-selected Western-style multiple cold medicine .


This study was a multicenter , active drug-controlled , randomized trial .


Adults @ to @ years of age who felt a touch of cold symptoms and visited @ outpatient healthcare facilities within @ hours of symptoms onset were enrolled .


The participants were randomly assigned to two groups : one treated with Kakkonto ( Kakkonto Extract-A , @ g/day ) ( n = @ ) and one treated with a Western-style multiple cold medicine ( Pabron Gold-A , @ g/day ) ( n = @ ) for at most four days .


The primary outcome of this study was the aggravation of cold , nasal , throat or bronchial symptoms , scored as moderate or severe and lasting for at least two days within five days after entry into the study .


Among the @ enrollees , @ ( @ in the Kakkonto group and @ in the Pabron group ) were included in the analyses .


The proportion of participants whose colds were aggravated was @ % in the Kakkonto group and @ % in the Pabron group ( p = @ ) .


The overall severity of the cold symptoms was not significantly different between the groups .


No harmful adverse events occurred in either group .


Kakkonto did not significantly prevent the progression of cold symptoms , even when prescribed at an early stage of the disease .


Compared with healthy individuals , those with upper respiratory tract illnesses ( URTIs ) report reduced alertness and have slower reaction times .


It is important to evaluate medication that can remove this behavioural malaise .


The aim of this study was to compare the effects of a combination of ibuprofen plus caffeine with ibuprofen and caffeine alone , and placebo on malaise associated with URTIs , as measured by psychomotor performance and mood testing .


Volunteers were randomly assigned to one of four medication conditions as follows : @mg ibuprofen and @mg caffeine ; @mg ibuprofen ; @mg caffeine ; placebo .


A single oral dose was given and testing followed for @h .


Efficacy variables were based on the volunteers ' performance , measured by psychomotor performance and mood .


The pre-drug results confirmed that those with an URTI had a more negative mood and impaired performance .


Results from the simple reaction time task , at both @ - and @-min post-dosing , showed that a single-dose of caffeinated products ( I@/C@ and CAF@ ) led to significantly faster reaction times than IBU@ and placebo .


These effects were generally confirmed with the other performance tasks .


Subjective measures showed that the combination of ibuprofen and caffeine was superior to the other conditions .


There were no serious adverse events reported , and study medication was well tolerated .


The results from the post-drug assessments suggest that a combination of ibuprofen and caffeine was the optimum treatment for malaise associated with URTIs in that it had significant effects on objective performance and subjective measures .


Recent studies evaluated the disease-modifying properties of lithium in mild cognitive impairment and dementia .