Mahjong led to a gradual improvement in global functioning and a slightly slower rate of dementia progression over time .


The effect was generalized and was not specific to cognition or daily functioning .


There are limited treatment options for tissue restoration and the prevention of degenerative changes in the knee .


Stem cells have been a focus of intense preclinical research into tissue regeneration but limited clinical investigation .


In a randomized , double-blind , controlled study , the safety of the intra-articular injection of human mesenchymal stem cells into the knee , the ability of mesenchymal stem cells to promote meniscus regeneration following partial meniscectomy , and the effects of mesenchymal stem cells on osteoarthritic changes in the knee were investigated .


A total of fifty-five patients at seven institutions underwent a partial medial meniscectomy .


A single superolateral knee injection was given within seven to ten days after the meniscectomy .


Patients were randomized to one of three treatment groups : Group A , in which patients received an injection of @ @ allogeneic mesenchymal stem cells ; Group B , @ @ allogeneic mesenchymal stem cells ; and the control group , a sodium hyaluronate ( hyaluronic acid/hyaluronan ) vehicle control .


Patients were followed to evaluate safety , meniscus regeneration , the overall condition of the knee joint , and clinical outcomes at intervals through two years .


Evaluations included sequential magnetic resonance imaging ( MRI ) .


No ectopic tissue formation or clinically important safety issues were identified .


There was significantly increased meniscal volume ( defined a priori as a @ % threshold ) determined by quantitative MRI in @ % of patients in Group A and @ % in Group B at twelve months post meniscectomy ( p = @ ) .


No patients in the control group met the @ % threshold for increased meniscal volume .


Patients with osteoarthritic changes who received mesenchymal stem cells experienced a significant reduction in pain compared with those who received the control , on the basis of visual analog scale assessments .


There was evidence of meniscus regeneration and improvement in knee pain following treatment with allogeneic human mesenchymal stem cells .


These results support the study of human mesenchymal stem cells for the apparent knee-tissue regeneration and protective effects .


Amyotrophic lateral sclerosis patients have significant respiratory abnormalities with incomplete understanding of respiratory control .


This study analyzes electromyography ( EMG ) of the diaphragm ( dEMG ) using implanted diaphragm pacing ( DP ) electrodes .


Retrospective analysis of dEMG data were obtained during Institutional Review Board and US Food and Drug Administration approved trials .


The electrodes were used to analyze epochs of dEMG during multiple respiratory cycles .


Fifty-three patients were implanted .


Thirty-six had bilateral dEMG assessments , @ had continuous overnight readings with pulse oximetry , and @ had serial analysis .


Several findings revealed an alteration in the central respiratory drive including central apnea , hypoventilation , and hypercarbia .


The electrodes showed unilateral dysfunction and demonstrated noninvasive ventilation suppression of diaphragm activity .


DP can be used for serial monitoring , to decrease hypercarbia , improve sleep , and decrease atrophy .


Multiple abnormalities of respiratory control can be seen in amyotrophic lateral sclerosis patients using dEMG through therapeutic DP electrodes .


DP is used to overcome instability of respiratory control when there are intact diaphragm motor units leading to improved survival .


Atherosclerotic cardiovascular disease ( CVD ) is the most common cause of morbidity and mortality among hemodialysis ( HD ) patients .


It has been attributed , among other causes , to hypertension and dyslipidemia .


The aim of the present study was to investigate the effect of a year-long consumption of Pomegranate juice ( PJ ) , on two traditional cardiovascular ( CV ) risk factors : hypertension and lipid profile , as well as on cardiovascular events .


@ HD patients were randomized to receive @cc of PJ ( @ mM polyphenols ) or matching placebo juice , three times a week for one year .


The primary endpoints were traditional CV risk factors ; blood pressure and lipid profile .


Systolic , diastolic and pulse pressure , plasma levels of triglycerides ( TG ) , high density lipoprotein ( HDL ) , low density lipoprotein ( LDL ) and total cholesterol were monitored quarterly during the study year .


Secondary endpoint was incidence of cardiovascular events .


PJ consumption yielded a significant time response improvement in systolic blood pressure , pulse pressure , triglycerides and HDL level ; an improvement that was not observed in the placebo intake group .


These beneficial outcomes were more pronounced among patients with hypertension , high level of triglycerides and low levels of HDL .


Regular PJ consumption by HD patients reduced systolic blood pressure and improved lipid profile .


These favorable changes may reduce the accelerated atherosclerosis and high incidence of CVD among HD patients .


Statins and calcium channel blockers have been proven beneficial toward improvement of endothelial function .


The aim of this study was to compare the effect of combination therapy of statin and calcium channel blocker with solo treatment in patients with cardiac syndrome X.


Sixty-eight patients with cardiac syndrome X were divided randomly into three groups : fluvastatin ( @ mg/day , n = @ ) , diltiazem ( @ mg/day , n = @ ) , and combination of fluvastatin ( @ mg/day ) and diltiazem ( @ mg/day , n = @ ) .


At the end of @ days , the coronary flow reserve was improved in the three groups ( fluvastatin-treated group : @ % ; diltiazem-treated group : @ % ; fluvastatin + diltiazem-treated group : @ % , all P < @ ) .


The time to @ mm ST segment depression increased significantly in the fluvastatin-treated group ( from @ to @ s , P < @ ) , the diltiazem-treated group ( from @ to @ s , P < @ ) , and the fluvastatin + diltiazem-treated group ( from @ to @ s , P < @ ) .


The improvement in coronary flow reserve and prolonged time to @ mm ST segment depression in the combination treatment group were more remarkable than in those who received monotherapy .


Combination therapy also induced a significant increase ( @ % , P < @ ) in nitric oxide and an apparent reduction ( @ % , P < @ ) in endothelin-@ .


Combination treatment with fluvastatin and diltiazem is more effective on endothelial function and exercise tolerance than solo treatment in patients with cardiac syndrome X.


The benefits of these drugs may be related to the elevation of nitric oxide and reduction of endothelin-@ .


Pulmonary embolism ( PE ) is the third most common cause of death from cardiovascular disease .


Computed-tomographic pulmonary angiography ( CTPA ) is an accurate and safe test for diagnosing PE .


The aim of this retrospective analysis was to evaluate the effects on image quality ( IQ ) of electrocardiogram ( ECG ) gating during CTPA .


Fifty consecutive patients presenting for CTPA were included in the study .


A single acquisition was performed , resulting in two reconstructions : one at @ % of the R-R interval and the other without ECG influence .


IQ evaluation was undertaken by two radiologists , focusing on respiratory and cardiac motion , image noise , low-contrast resolution , vessel and lung clarity , contrast media opacification and artefacts .


Various regions of the lungs and vasculature were evaluated , and IQ scores were statistically compared .


For the ECG-tagged reconstructions , IQ was noted to be better overall with regard to vessel clarity ( P < @ ) and cardiac motion ( P < @ ) , while lung clarity was better only in the left lower zone ( P < @ ) .


IQ was better with regard to image noise ( P < @ ) and low-contrast resolution ( P < @ ) in the non-ECG-tagged reconstructions .


No statistical IQ difference between the two types of reconstruction was noted with regard to respiratory motion , contrast media opacification or presence of artefacts .


The two types of reconstruction provide complementary information for evaluating CTPA results .


Adaptive support ventilation ( ASV ) is a closed loop mode of mechanical ventilation ( MV ) that provides a target minute ventilation by automatically adapting inspiratory pressure and respiratory rate with the minimum work of breathing on the part of the patient .


The aim of this study was to determine the effect of ASV on total MV duration when compared with pressure assist/control ventilation .


Adult medical patients intubated and mechanically ventilated for > @ h in a medical ICU were randomized to either ASV or pressure assist/control ventilation .


Sedation and medical treatment were standardized for each group .


Primary outcome was the total MV duration .


Secondary outcomes were the weaning duration , number of manual settings of the ventilator , and weaning success rates .


Two hundred twenty-nine patients were included .


Median MV duration until weaning , weaning duration , and total MV duration were significantly shorter in the ASV group ( @ -LSB- @-@ -RSB- h vs @ -LSB- @-@ -RSB- h , P = @ ; @ -LSB- @-@ -RSB- h vs @ -LSB- @-@ -RSB- h , P = @ ; and @ -LSB- @-@ -RSB- days vs @ -LSB- @-@ -RSB- days , P = @ , respectively ) .


Patients in the ASV group required fewer total number of manual settings on the ventilator to reach the desired pH and Paco@ levels ( @ -LSB- @-@ -RSB- vs @ -LSB- @-@ -RSB- , P < @ ) .


The number of patients extubated successfully on the first attempt was significantly higher in the ASV group ( P = @ ) .


Weaning success and mortality at day @ were comparable between the two groups .


In medical patients in the ICU , ASV may shorten the duration of weaning and total MV duration with a fewer number of manual ventilator settings .


We aim to test the hypothesis that high plasma YKL-@ is associated with short progression-free survival ( PFS ) and overall survival ( OS ) in patients with metastatic colorectal cancer ( mCRC ) treated with first-line oxaliplatin and @-flourouracil with or without cetuximab .


A total of @ patients in the NORDIC VII Study were randomized @ to arm A ( Nordic FLOX ) , arm B ( Nordic FLOX + cetuximab ) , or arm C ( Nordic FLOX + cetuximab for @ weeks followed by cetuximab alone as maintenance therapy ) .


Pretreatment plasma samples were available from @ patients .


Plasma YKL-@ was determined by ELISA and dichotomized according to the age-corrected @ % YKL-@ level in @ healthy subjects .


Pretreatment plasma YKL-@ was elevated in @ patients ( @ % ) , and median YKL-@ was higher in patients with mCRC than in healthy subjects ( age adjusted , P < @ ) .


Patients with elevated YKL-@ had shorter PFS than patients with normal YKL-@ ( @ vs. @ months ; hazard ratio ( HR ) = @ @ % confidence interval ( CI ) @-@ @ P = @ ) and shorter OS ( @ vs. @ months ; HR = @ , @-@ @ , P = @ ) .


Multivariate Cox analysis demonstrated that elevated pretreatment YKL-@ was an independent biomarker of short OS ( HR = @ , @-@ @ , P = @ ) .


The ratio of the updated plasma YKL-@ ( i.e. level after @ , @ , @ weeks of treatment , and at end of treatment compared to the baseline level ) was associated with OS ( HR = @ , @-@ @ , P = @ ) .


Plasma YKL-@ is an independent prognostic biomarker in patients with mCRC treated with first-line oxaliplatin-based therapy alone or combined with cetuximab .


Intra-myocardial transplantation of CD@ ( + ) bone marrow stem cells ( BMC ) yielded promising results in clinical pilot trials .


We now performed the double-blinded , randomized , placebo-controlled CARDIO@ trial to determine its impact on left ventricular ( LV ) function and clinical symptoms .


Sixty patients with chronic ischaemic heart disease and impaired LV function ( left ventricular ejection fraction , LVEF < @ % ) were randomized to undergo either coronary artery bypass grafting ( CABG ) and injection of CD@ ( + ) BMC in the non-transmural , hypokinetic infarct border zone ( CD@ ) , or CABG and placebo injection ( placebo ) .


Pre-operative LVEF was @ @ % in CD@ patients and @ @ % in placebo patients .


Outcome was assessed after @ months , and the primary endpoint was LVEF measured by cardiac magnetic resonance imaging ( MRI ) at rest .


The incidence of adverse events was similar in both groups .


There was no difference in @-min walking distance , Minnesota Living with Heart Failure score , or Canadian Cardiovascular Society ( CCS ) class between groups at follow-up , and New York Heart Association class improved more in the placebo group ( P = @ ) .


By cardiac MRI , LVEF at @ months was @ @ % in the placebo group and @ @ % in verum patients ( P = @ ) , with an average inter-group difference of -@ % ( @ % CI -@ to @ ) .


Systolic or diastolic LV dimensions at @ months were not different , either .


In the CD@ group , myocardial perfusion at rest recovered in more LV segments than in the placebo group ( @ vs. @ % , P < @ ) .


Scar mass decreased by @ @ g in CD@ ( + ) patients ( P = @ ) , but was unchanged in the placebo group ( @ @ g , P = @ ; inter-group difference in change = @ g ( @ % CI -@ to @ ) ) .


By speckle-tracking echocardiography , cell-treated patients showed a better recovery of regional wall motion when the target area was posterior .


Although there may be some improvements in scar size and regional perfusion , intra-myocardial injection of CD@ ( + ) BMC has no effect on global LV function and clinical symptoms .


Improvements in regional myocardial function are only detectable in patients with posterior infarction , probably because the interventricular septum after anterior infarction is not accessible by trans-epicardial injection .


Although adolescent girls are the main population for prophylactic human papillomavirus ( HPV ) vaccines , adult women who remain at risk of cervical cancer can also be vaccinated .


We report data from the interim analysis of the ongoing VIVIANE study , the aim of which is to assess the efficacy , safety , and immunogenicity of the HPV @/@ AS@-adjuvanted vaccine in adult women .


In this phase @ , multinational , double-blind , randomised controlled trial , we randomly assigned healthy women older than @ years to the HPV @/@ vaccine or control ( @:@ ) , via an internet-based system with an algorithm process that accounted for region , age stratum , baseline HPV DNA status , HPV @/@ serostatus , and cytology .


Enrolment was age-stratified , with about @ % of participants in each of the @-@ and @-@ years age strata and @ % in the @ years and older stratum .


Up to @ % of women in each age stratum could have a history of HPV infection or disease .


The primary endpoint was vaccine efficacy against @-month persistent infection or cervical intraepithelial neoplasia grade @ or higher ( CIN@ + ) associated with HPV @/@ .


The primary analysis was done in the according-to-protocol cohort for efficacy , which consists of women who received all three vaccine or control doses , had negative or low-grade cytology at baseline , and had no history of HPV disease .


Secondary analyses included vaccine efficacy against non-vaccine oncogenic HPV types .


Mean follow-up time was @ months .


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


The first participant was enrolled on Feb @ , @ , and the last study visit for the present analysis took place on Dec @ , @ ; @ women were included in the total vaccinated cohort ( n = @ vaccine , n = @ control ) , and @ in the according-to-protocol cohort for efficacy ( n = @ vaccine , n = @ control ) .


Vaccine efficacy against HPV @/@-related @-month persistent infection or CIN@ + was significant in all age groups combined ( @ % , @ % CI @-@ ) , in the @-@ years age group ( @ % , @-@ ) , and in the @-@ years age group ( @ % , @-@ ) ; no cases were seen in women aged @ years and older .


Vaccine efficacy against atypical squamous cells of undetermined significance or greater associated with HPV @/@ was also significant .


We also noted significant cross-protective vaccine efficacy against @-month persistent infection with HPV @ ( @ % , @ % CI @-@ ) and HPV @ ( @ % , @-@ -RSB- ) Serious adverse events occurred in @ ( @ % ) of @ women in the vaccine group and @ ( @ % ) of @ in the control group ; five ( < @ % ) and eight ( < @ % ) of these events , respectively , were believed to be related to vaccination .


In women older than @ years , the HPV @/@ vaccine is efficacious against infections and cervical abnormalities associated with the vaccine types , as well as infections with the non-vaccine HPV types @ and @ .


To describe the predictors of nurse actions in response to a mobile health decision-support system ( mHealth DSS ) for guideline-based screening and management of tobacco use .


Observational design focused on an experimental arm of a randomized , controlled trial .


Acute and ambulatory care settings in the New York City metropolitan area .


@,@ patient encounters in which @ RNs enrolled in advanced practice nurse ( APN ) training were prompted by an mHealth DSS to screen for tobacco use and select guideline-based treatment recommendations .


Data were entered and stored during nurse documentation in the mHealth DSS and subsequently stored in the study database where they were retrieved for analysis using descriptive statistics and logistic regressions .


Predictor variables included patient gender , patient race or ethnicity , patient payer source , APN specialty , and predominant payer source in clinical site .


Dependent variables included the number of patient encounters in which the nurse screened for tobacco use , provided smoking cessation teaching and counseling , or referred patients for smoking cessation for patients who indicated a willingness to quit .


Screening was more likely to occur in encounters where patients were female , African American , and received care from a nurse in the adult nurse practitioner specialty or in a clinical site in which the predominant payer source was Medicare , Medicaid , or State Children 's Health Insurance Program .


In encounters where the patient payer source was other , nurses were less likely to provide tobacco cessation teaching and counseling .


mHealth DSS has the potential to affect nurse provision of guideline-based care .


However , patient , nurse , and setting factors influence nurse actions in response to an mHealth DSS for tobacco cessation .


The combination of a reminder to screen and integration of guideline-based recommendations into the mHealth DSS may reduce racial or ethnic disparities to screening , as well as clinician barriers related to time , training , and familiarity with resources .


Although iron supplementation in malaria-free areas mostly reduces infectious morbidity , it can sometimes increase morbidity from infections as a result of the dependence of pathogenic microorganisms on iron .


Supplementation with n-@ ( -@ ) long-chain polyunsaturated fatty acids ( LCPUFAs ) improved morbidity in several human studies .


However , information on the combined effect of iron and n-@ LCPUFA supplementation on infectious morbidity is limited .


We determined whether n-@ LCPUFAs and iron supplementation , alone or in combination , affected absenteeism and illness in iron-deficient schoolchildren with low fish intake .


A total of @ South African children ( aged @-@ y ) with iron deficiency ( ID ) were randomly divided into @ groups to receive @ ) iron plus placebo , @ ) a mixture of docosahexaenoic acid and eicosapentaenoic acid ( DHA/EPA ) plus placebo , @ ) iron plus DHA/EPA , or @ ) placebo plus placebo as oral supplements @ times/wk for @ mo. .


Morbidity was recorded , and iron-status indexes were measured .


The total phospholipid fatty acid composition of peripheral blood mononuclear cell membranes was analyzed in a subsample ( n = @ ) .


Iron supplementation increased the number of days with illness when all symptoms were considered ( B : @ ; @ % CI : @ , @ ) as well as illness that was specifically caused by respiratory symptoms ( B : @ ; @ % CI : @ , @ ) , whereas DHA/EPA reduced the number of days with illness at school ( B : -@ ; @ % CI : -@ , -@ ) .


The increases caused by iron were reduced to the levels seen in the placebo plus placebo group when iron was provided in combination with DHA/EPA as indicated by significant iron DHA/EPA interactions ( both P < @ ) .


Iron supplementation increased morbidity ( mostly respiratory ) in iron-deficient South African schoolchildren with low DHA/EPA intake , but when iron was given in combination with DHA/EPA , this effect was prevented .


Anorexia nervosa ( AN ) is a serious disorder with high rates of morbidity and mortality .


Family-based treatment ( FBT ) is an evidence-based therapy for adolescent AN , but less than half of those who receive this approach recover .


Hence , it is important to identify other approaches to prevent the development of the chronic form of AN for which there is no known evidence-based treatment .


To compare FBT with systemic family therapy ( SyFT ) for the treatment of adolescent-onset AN .


Research in Anorexia Nervosa ( RIAN ) is a @-group ( FBT and SyFT ) randomized trial conducted between September @ and April @ .


Interviewers were blinded to the treatment condition .


A total of @ adolescents receiving care at @ outpatient clinics experienced in the treatment of AN were screened .


Of these , @ adolescents did not meet the inclusion criteria and @ declined to participate ; hence , @ adolescents ( aged @-@ years ) of both sexes meeting the criteria for Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , AN ( except for amenorrhea ) were enrolled .


Three participants were withdrawn from FBT and @ were withdrawn from SyFT after serious adverse events occurred .


Two manualized family therapies with @ one-hour sessions during @ months .


Family-based therapy focuses on the facilitation of weight gain , whereas SyFT addresses general family processes .


The primary outcomes were percentage of ideal body weight ( IBW ) and remission ( @ % of IBW ) .


The a priori hypothesis was that FBT would result in faster weight gain early in treatment and at the end of treatment ( EOT ) .


There were no statistically significant differences between treatment groups for the primary outcome , for eating disorder symptoms or comorbid psychiatric disorders at the EOT or follow-up .


Remission rates included FBT , @ % at the EOT and @ % at follow-up and SyFT , @ % and @ % , respectively .


Family-based therapy led to significantly faster weight gain early in treatment , significantly fewer days in the hospital , and lower treatment costs per patient in remission at the EOT ( FBT , $ @ ; SyFT , $ @ ) .


An exploratory moderator analysis found that SyFT led to greater weight gain than did FBT for participants with more severe obsessive-compulsive symptoms .


The findings of this study suggest that FBT is the preferred treatment for adolescent AN because it is not significantly different from SyFT and leads to similar outcomes at a lower cost than SyFT .


Adolescents with more severe obsessive-compulsive symptoms may receive more benefits with SyFT .


The aim of the present study was to assess the efficacy of structured education in insulin-treated type @ diabetes mellitus ( T@DM ) patients .


In a @-week open-label randomized controlled study , @ T@DM patients with inadequate responses to two or more oral antidiabetic drugs ( OADs ) for > @ months ( HbA@c > @ % ) were randomized ( @:@ ) to either an education group ( structured diabetes education plus insulin therapy ) or a control group ( usual care plus insulin therapy ) .


Both groups discontinued previous OADs ( except biguanides and - glucosidase inhibitors ) and started twice daily injections of @ % soluble-@ % isophane recombinant insulin .


The primary endpoint was the change in HbA@c from baseline .


Efficacy and safety data were analyzed for within - and between-group differences .


Of the initial @ patients , @ completed the study ( @ in the control group ; @ in the education group ) .


At the end of the study , significant reductions in HbA@c versus baseline were evident in both groups , but the reduction was greater in the education group ( @ % vs. @ % ; P < @ ) .


A higher proportion of patients in the education group achieved target HbA@c levels < @ % ( @ % vs. @ % ; P < @ ) and @ % ( @ % vs. @ % ; P < @ ) .


In addition , patients in the education group showed greater increments in scores and improvement in the Morisky Medication Adherence Scale ( P < @ ) .


The overall incidence of hypoglycemic events was similar in the two groups .


Structured education can promote the ability of patients to self-manage and their compliance with medications , thereby achieving better outcomes .


The present study is a comparison of two point-of-care ( POC ) tests as endpoints of protamine titration after CPB .


The authors hypothesized that using the heparinase-kaolin thromboelastography ( TEG-HK ) R-time difference would more readily identify residual heparin necessitating additional protamine than when using activated coagulation time ( ACT ) .


The primary endpoint was the between-group difference in protamine dose .


Whether this approach would lessen postoperative bleeding and sequelae also was investigated .


Single center , blinded , prospective , randomized study .


University teaching hospital .


Eighty-two adult patients for on-pump coronary artery bypass and/or valve surgery .


Patients were randomized .


In the ACT group , protamine was titrated until ACT did not exceed baseline by more than @ % .


In the TEG group , a TEG-HK R-time difference less than @ % was targeted .


Protamine was repeated to achieve the endpoints .


Clinicians in the ACT group were blinded to TEG data and vice versa .


There was no between-group difference in total protamine dose ( @ @ and @ @ ; @ % CI of the difference between means : -@ to @ mg/kg ; p = @ ) or protamine : heparin ratios ( @:@ and @:@ ; @ % CI of the difference between means : -@ to @ mg/mg ; p = @ ) .


In the ACT group , @ % of patients required a second protamine dose , and in the TEG group , @ % of patients required a second protamine dose .


No between-group differences in the postoperative transfusion requirements or intensive care unit length of stay were demonstrated .


No difference was identified in protamine dosing using either ACT or TEG-HK R-time difference as endpoints .


Heparinase TEG may be useful for monitoring heparin reversal .


Clinical practice guidelines are considered important instruments to improve quality of care .


However , success is dependent on adherence , which may be improved using peer assessment , a strategy in which professionals assess performance of their peers in a simulated setting .


The aim of this study was to determine whether peer assessment is more effective than case-based discussions to improve knowledge and guideline-consistent clinical reasoning in the Dutch physical therapy guideline for low back pain ( LBP ) .


A cluster randomized controlled trial was conducted .


Ten communities of practice ( CoPs ) of physical therapists were cluster randomized ( N = @ ) : @ CoPs in the peer-assessment group ( n = @ ) and @ CoPs in the case-based discussion group ( control group ) ( n = @ ) .


Both groups participated in @ educational sessions and used clinical patient cases .


The peer-assessment group reflected on performed LBP management in different roles .


The control group used structured discussions .


Outcomes were assessed at baseline and at @ months .


The primary outcome measure was knowledge and guideline-consistent reasoning , measured with @ performance indicators using @ vignettes with specific guideline-related patient profiles .


For each participant , the total score was calculated by adding up the percentage scores ( @-@ ) per vignette , divided by @ .


The secondary outcome measure was reflective practice , as measured by the Self-Reflection and Insight Scale ( @-@ ) .


Vignettes were completed by @ participants ( @ % ) .


Multilevel analysis showed an increase in guideline-consistent clinical reasoning of @ % in the peer-assessment group , whereas the control group showed a decline of @ % ( estimated group difference = @ % , @ % confidence interval = @ to @ ) .


No group differences were found on self-reflection .


The small sample size , a short-term follow-up , and the use of vignettes as a proxy for behavior were limitations of the study .


Peer assessment leads to an increase in knowledge and guideline-consistent clinical reasoning .


Eczema is one of the most common chronic inflammatory skin diseases , affecting about @ % of children .


The pathogenic mechanisms of eczema are still not fully understood , and current treatment of moderate-severe eczema is often difficult .


Recently , it has been suggested that Vitamin D plays a key role in this disease , even if mechanisms are only partially known .


The purpose of our study was to assess the @-Hydroxyvitamin D serum levels in a pediatric population suffering from chronic eczema ( IgE-mediated and non-IgE-mediated ) , and to correlate these phenotypes with the SCORAD severity and selected clinical and biological parameters .


Moreover , we aimed to evaluate whether a supplementation of Vitamin D@ could affect the same clinical and laboratory parameters .


@ children with chronic eczema were enrolled in the study .


Severity of eczema was assessed with the SCORAD index .


Past and present history was taken , and patients were divided into two groups according to the state of sensitization .


According to a randomization schedule , the enrolled children were assigned to the following groups : supplementation group , which received a daily oral Vitamin D@ supplementation ( @ IUs ) for @ months ; control group which received no supplementation .


Vitamin D concentrations in patients with moderate and severe eczema were not statistically different from Vitamin D concentration detected in the serum of patients with mild eczema .


Furthermore , we did not find any correlation between Vitamin D levels , total IgEs and SCORAD index , both in the Sensitized and in the Not-Sensitized group .


The Vitamin D@ supplementation did not influence the SCORAD severity or the total IgEs concentration .


To our knowledge , our study is the first one that shows no correlation between serum levels of Vitamin D , eczema severity and IgE sensitization in a pediatric population suffering from chronic eczema .


Up to @ % of severely injured patients develop trauma-induced coagulopathy .


To study interventions for this vulnerable population for whom consent can not be obtained easily , the Food and Drug Administration issued regulations for emergency research with an exception from informed consent ( ER-EIC ) .


We describe the community consultation and public disclosure ( CC/PD ) process in preparation for an ER-EIC study , namely the Control Of Major Bleeding After Trauma ( COMBAT ) study .


The CC/PD was guided by the four bioethical principles .


We used a multimedia approach , including one-way communications ( newspaper ads , brochures , television , radio , and web ) and two-way communications ( interactive in-person presentations at community meetings , printed and online feedback forms ) to reach the trials catchment area ( Denver County 's population : @,@ and the Denver larger metro area where commuters reside : @ million ) .


Particular attention was given to special-interests groups ( eg , Jehovah Witnesses , homeless ) and to Spanish-speaking communities ( brochures and presentations in Spanish ) .


Opt-out materials were available during on-site presentations or via the COMBAT study website .


A total of @ community organizations were contacted .


Brochures were distributed to @ medical clinics and @ homeless shelters .


The multimedia campaign had the potential to reach an estimated audience of @ million individuals in large metro Denver area , the majority via one-way communication and @ in two-way communications .


This resource intensive process cost more than $ @,@ .


The CC/PD process is resource-intensive , costly , and complex .


Although the multimedia CC/PD reached a large audience , the effectiveness of this process remains elusive .


The templates can be helpful to similar ER-EIC studies .


To assess the clinical curative effect of fuzi-cake-separated moxibustion at Zhongji ( CV @ ) and Guanyuan ( CV @ ) for preventing dysuria after internal fixation of lower limb fractures .


Sixty patients conforming to the inclusion standards were randomly divided into a treatment group ( n = @ ) and a control group ( n = @ ) .


Fuzi-cake-separated moxibustion was performed at Guanyuan ( CV @ ) and Zhongji ( CV @ ) , @ min at a time , twice a day , for @ days before operation in the treatment group .


No fuzi-cake-separated moxibustion was performed in the control group .


After treatment , the score for symptoms of first urination , urinary time , urinary volume , @ h remaining urinary volume , incidence of uroschesis , and rate of controlling dysuria were compared to evaluate the curative effect of preventing post-operative dysuria .


The score for symptoms of first urination , @ h remaining urinary volume ( maximum @ mL vs @ ml , and less than @ ml in @ cases vs @ cases ) , and the rate of controlling dysuria ( @ % vs @ % ) were significantly better ( P < @ , P < @ , and P < @ , respectively ) in the treatment compared with the control group .


There was no statistical difference ( P > @ ) between the two groups in first post-operative urinary time , urinary volume , or incidence of @ h uroschesis .


Fuzi-cake-separated moxibustion at Zhongji ( CV @ ) and Guanyuan ( CV @ ) can better prevent post-operative dysuria , effectively promote the functional restoration of the urinary bladder , and control the incidence of post-operative dysuria .


Chronic angina is a profoundly symptomatic disease .


We evaluated the relationship between angina frequency and health utility .


We used data from stable angina patients reporting @ attacks/week enrolled in the Efficacy of Ranolazine in Chronic Angina ( ERICA ) trial .


Angina frequency was classified using the Seattle Angina Questionnaire angina frequency ( SAQAF ) domain into no ( @ ) ; monthly ( @-@ ) ; weekly ( @-@ ) ; and daily ( @-@ ) angina .


EuroQol ( EQ ) -@ D health utility scores were derived from SAQ data using two mapping equations .


Median EQ-@D utility scores for each SAQAF classification after the @-week trial period were calculated ( reported as : Equation @/Equation @ ) .


Changes in EQ-@D utility scores from baseline to end-of-trial for patients achieving and not achieving a @-point improvement in SAQAF score and improving and not improving @ SAQAF classification were compared .


Median EQ-@D utility scores ( n = @ ) were @ / @ .


Compared to patients reporting no angina symptoms ( n = @ ; @ / @ ) patients reporting monthly ( n = @ ; @ / @ ) , weekly ( n = @ ; @ / @ ) and daily ( n = @ ; @ / @ ) symptoms had poorer health utility ( p < @ for both equations ) .


Patients improving @SAQAF classification ( n = @/@ , @ % ) experienced a median @ / @ greater improvement in EQ-@D health utility compared to those not improving @ classification ( p < @ for both equations ) .


Patients improving @-points on the SAQAF ( n = @/@ , @ % ) experienced a median @ / @ greater improvement in health utility compared to those not achieving a @-point improvement ( p < @ for both ) .


Chronic angina patient health utility decreases as angina frequency increases .


Patients reporting clinically important improvement in angina frequency experience a tangible improvement in health utility .


Patients with bipolar disorder often show decreased adherence with mood stabilizers and frequently interventions on prodromal depressive and manic symptoms are delayed .


Recently , the MONARCA I randomized controlled trial investigated the effect of electronic self-monitoring using smartphones on depressive and manic symptoms .


The findings suggested that patients using the MONARCA system had more sustained depressive symptoms than patients using a smartphone for normal communicative purposes , but had fewer manic symptoms during the trial .


It is likely that the ability of these self-monitored measures to detect prodromal symptoms of depression and mania may be insufficient compared to automatically generated objective data on measures of illness activity such as phone usage , social activity , physical activity , and mobility .


The Monsenso system , for smartphones integrating subjective and objective measures of illness activity was developed and will be tested in the present trial .


The MONARCA II trial uses a randomized controlled single-blind parallel-group design .


Patients with bipolar disorder according to ICD-@ who previously have been treated at the Copenhagen Clinic for Affective Disorder , Denmark are included and randomized to either daily use of the Monsenso system including an feedback loop between patients and clinicians ( the intervention group ) or to the use of a smartphone for normal communicative purposes ( the control group ) for a @-month trial period .


The trial was started in September @ and recruitment is ongoing .


The outcomes are : differences in depressive and manic symptoms ; rate of depressive and manic episodes ( primary ) ; automatically generated objective data on measures of illness activity ; number of days hospitalized ; psychosocial functioning ( secondary ) ; perceived stress ; quality of life ; self-rated depressive symptoms ; self-rated manic symptoms ; recovery ; empowerment and adherence to medication ( tertiary ) between the intervention group and the control group during the trial .


Ethical permission has been obtained .


Positive , neutral and negative findings will be published .


If the system is effective in reducing depressive and/or manic symptoms ( and other symptoms of bipolar disorder ) and the rate of episodes , there will be basis for extending the use to the treatment of bipolar disorder in general and in larger scale .


There are scarce data regarding the impact of sphincterotome design on cannulation success .


We aimed to compare two different @ Fr standard sphincterotomes to determine initial cannulation success .


Adult patients with naive papillae were enrolled in a prospective , randomized , crossover study .


Two different @ Fr sphincterotomes preloaded with guidewire ( GW ) were used in two groups with @ patients included per group .


A total of five papillary attempts and two pancreatic channel entries were allowed as maximum targets .


In a case of more than two pancreatic entries , a double GW technique was attempted before crossover .


If choledochal cannulation was not achieved within ten papillary attempts or more than four pancreatic entries despite crossover , access papillotomy was performed .


Successful biliary cannulation was the primary outcome .


Secondary outcomes were incidence of early complications and overall cannulation success .


Higher initial cannulation success was achieved in group I compared with group II ( @ vs. @ % , p = @ ) .


The crossover and double GW techniques reduced the need for precut from @ to @ % .


The overall cannulation success including precut for failed cases was @ % ( group I ) and @ % ( group II ) .


Sphincterotome type , presence of crossover , and number of cannulation attempts were predictors of successful cannulation in multivariate analysis .


There was a significant difference in cannulation success between two different @ Fr sphincterotomes .


The cannulation success was mainly governed by sphincterotome design which serves a proper spatial orientation during the procedure .


The combined use of crossover and double GW techniques may substantially decrease precut necessity .


Providing written medicine information to consumers enables them to make informed decisions about their medicines , playing an important role in educating and improving health literacy .


In Australia , standardized written medicine information called Consumer Medicine Information ( CMI ) is available for medicines as package inserts , computer prints , or leaflets .


Consumers want and read CMI , but may not always ask for it .


General practitioners ( GPs ) and pharmacists are an important source of written medicine information , yet may not always provide CMI in their practice .


To examine and compare the awareness , use and provision of CMI by consumers , pharmacists and general practitioners ( GPs ) .


Based on previous studies , structured questionnaires were developed and administered to a national sample of consumers ( phone survey ) ; community pharmacists and GPs ( postal surveys ) about utilization of CMI .


Descriptive , comparative and logistic regression analyses were conducted .


The respondents comprised of @ pharmacists , @ GPs and @ consumers .


Two-thirds of consumers , nearly all ( @ % ) pharmacists and @ % of GPs were aware of CMI .


About @ % of consumers reported receiving CMI as a package insert , however most pharmacists ( @ % ) and GPs ( @ % ) reported providing computer-generated CMI .


GPs ' and pharmacists ' main reason for providing CMI was on patient request .


Reasons for not providing were predominantly because consumers were already taking the medicine , concerns regarding difficulty understanding the information , or potential non-adherence .


Of the @ consumers reportedly reading CMI , @ % indicated concerns after reading .


Factors associated with reading included gender , type of CMI received and frequency of provision .


Consumers want and read information about their medicines , especially when received from their GP or pharmacist .


Healthcare professionals report usually discussing CMI when providing it to patients , although continued improvements in dissemination rates are desirable .


Regular use of CMI remains a challenge , and ongoing strategies to promote CMI use are necessary to improve uptake of CMI in Australia .


The aim of this study was to compare the contrast-to-noise ratio ( CNR ) values of infarct and remote myocardium as well as infarct and blood after application of @ mmol/kg gadobutrol and @ mmol/kg gadobenate dimeglumine on late gadolinium enhancement magnetic resonance ( MR ) images .


The study was a prospective randomized controlled clinical study .


After informed consent was obtained , @ patients ( @ men , @ women ; mean age , @ @ years ) with known chronic myocardial infarction were included for an intraindividual comparison of a single-dose gadobutrol and a single-dose gadobenate dimeglumine .


Two MR imaging examinations were performed within a period of @ days in a crossover design .


Late gadolinium enhancement imaging was performed @ minutes after gadolinium administration using a @-dimensional phase-sensitive inversion recovery gradient echo sequence at @ T. Infarct size , signal intensities ( SIs ) , signal-to-noise ratio , and CNR were determined on phase-sensitive MR images .


Values for CNR were calculated as CNRinfarct/myocardium = ( SIinfarct - SImyocardium ) / SDnoise and CNRinfarct/blood = ( SIinfarct - SIblood ) / SDnoise .


In addition , the areas of myocardial infarction were determined on single slices .


The entire infarct volumes were calculated by adding the areas with hyperenhancement multiplied by the slice thickness .


Late gadolinium enhancement was present in all patients .


Median values of the infarct area , infarct volume , and transmurality for gadobutrol and gadobenate dimeglumine showed good to excellent concordance ( rc = @ , rc = @ , and rc = @ , respectively ) .


The mean signal-to-noise ratio values for infarct , remote myocardium , and ventricular blood were @ @ , @ @ , and @ @ , respectively , for gadobutrol and @ @ , @ @ , and @ @ , respectively , for gadobenate dimeglumine ( P = @ , P = @ , and P = @ , respectively ) .


The mean values of CNRinfarct/myocardium and CNRinfarct/blood were @ @ and @ @ , respectively , for gadobutrol and @ @ and @ @ , respectively , for gadobenate dimeglumine ( P = @ and P = @ , respectively ) .


Both gadobutrol and gadobenate dimeglumine allow for successful late gadolinium enhancement imaging of chronic myocardial infarction after a single-dose application ( @ mmol/kg ) at @ T. Gadobutrol provides a higher CNR between infarct and blood .


The CNRs between infarct and normal myocardium , infarct size , and transmural extent were similar for both contrast agents .


Patients undergoing breast cancer surgery frequently experience chronic postoperative pain .


The primary objective of this randomized study was to determine if thoracic paravertebral block ( TPVB ) reduced the incidence of chronic pain after a modified radical mastectomy ( MRM ) when compared with general anesthesia ( GA ) .


One hundred eighty women undergoing MRM were randomized to @ of @ study groups : group @ : standardized GA , group @ : GA with a single-injection TPVB and placebo paravertebral infusion , and group @ : GA with a continuous TPVB .


Outcomes assessed postoperatively included acute postoperative pain and analgesic consumption and , at @ and @ months , the incidence and severity of chronic pain and physical and mental health-related quality of life ( HRQOL ) .


There was no significant difference in the incidence of chronic pain at @ months ( P = @ ) and @ months ( P = @ ) after the MRM between the study groups .


The relative risk of developing chronic pain ( P = @ ) was also similar between the groups .


There was no difference in acute pain ( P = @ ) or postoperative analgesic consumption ( P = @ ) between the groups .


Nevertheless , differences were observed in chronic pain-related secondary outcome variables .


The TPVB groups reported lower chronic pain scores ( P < @ ) , exhibited fewer symptoms and signs of chronic pain ( P @ ) , and also experienced better physical and mental HRQOL than did the GA group .


Chronic pain scores also decreased with time in all study groups ( P < @ ) .


There is no significant difference in the incidence or relative risk of chronic pain at @ and @ months after an MRM when TPVB is used in conjunction with GA. .


Nevertheless , patients who receive a TPVB report less severe chronic pain , exhibit fewer symptoms and signs of chronic pain , and also experience better physical and mental HRQOL .


Narrative exposure therapy ( NET ) is a brief , manualised treatment for Posttraumatic Stress Disorder ( PTSD ) .


It has been shown to have therapeutic benefits for a wide range of individuals and settings .


This study , following our previous work applying the original NET in earthquake survivors , aimed to revise NET to be adaptable for treating PTSD after a natural disaster .


A randomised waiting-list controlled study was conducted with @ adult participants with PTSD who were randomly allocated to NET ( n = @ ) , revised NET ( NET-R ; n = @ ) or a waiting list condition ( WL ; n = @ ) .


Participants in NET and NET-R received treatment immediately ; those in the WL condition received NET-R treatment after a waiting period .


All groups were assessed on PTSD , general distress , anxiety , depression , social support , coping and posttraumatic change before and after treatment and three-month follow-up .


Compared with WL , both NET and NET-R groups showed significant reductions in PTSD and related symptoms .


Significant increases were found in posttraumatic growth , active coping and perceived social support .


The WL group showed similar improvements after treatment .


Further reductions on PTSD symptoms were found at three months , showing that NET-R is as effective as the original NET in treating post-earthquake traumatic symptoms in adult Chinese earthquake survivors .


NET-R is a feasible and cost-effective intervention for Chinese earthquake survivors .


Further studies are needed to replicate these findings in other survivor populations , and with larger samples and over longer periods .


This study highlighted the value of oral narrative approach , which is well-accepted and useful in the context of single natural disaster and lower - income area .


The objective of the study was to test the diagnostic performance of low-dose computed tomography pulmonary angiography ( CTPA ) at peak tube voltage of @ kVp with both reduced radiation and reduced contrast material ( CM ) dose .


In this single-center , single-blinded prospective randomized trial , @ patients with body weights of less than @ kg with suspected acute pulmonary embolism ( PE ) were assigned to normal-dose CTPA ( @-kVp tube energy and @-mL CM , @ patients ) and low-dose CTPA ( @-kVp tube energy and @-mL CM , @ patients ) .


Primary end points were evidence of PE in CTPA and accuracy of CTPA on a composite reference standard .


Results were compared by calculating the odds ratio with the @ % confidence interval .


The reference diagnosis was equivocal in @ of the @ patients .


Diagnosis of CTPA was correct in @ patients and incorrect in @ in the normal-dose group .


Computed tomography pulmonary angiography was correct in @ patients and incorrect in @ in the low-dose group ( odds ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


Sensitivity was @ % and @ % and specificity was @ % and @ % in the normal-dose and low-dose groups , respectively .


No PE or PE-related death occurred during the @-day follow-up .


The size-specific dose estimates were @ % lower at @ kVp ( @ @ mGy ) compared with that at @ kVp ( @ @ mGy ; P < @ ) .


The accuracy of low-dose CTPA at @ kVp with a @ % reduced radiation dose and a @ % lower CM volume is not significantly different from that of normal-dose CTPA at @ kVp in detecting acute PE in patients weighing less than @ kg .


To evaluate the association of subretinal hyperreflective material ( SHRM ) with visual acuity ( VA ) , geographic atrophy ( GA ) , and scar in the Comparison of Age-Related Macular Degeneration Treatments Trials ( CATT ) .


Prospective cohort study within a randomized clinical trial .


The @ CATT participants .


Masked readers graded scar and GA on fundus photography and fluorescein angiography and graded SHRM on time-domain and spectral-domain ( SD ) optical coherence tomography ( OCT ) throughout @ weeks .


Measurements of SHRM height and width in the fovea , within the center @ mm ( @ ) , or outside the center @mm ( @ ) were obtained on SD OCT images at @ ( n = @ ) and @ ( n = @ ) weeks .


Presence of SHRM , as well as location and size , and associations with VA , scar , and GA. .


Among CATT participants , the percentage with SHRM at enrollment was @ % , decreasing to @ % at @ weeks after treatment and to @ % at @ weeks .


At @ weeks , scar was present more often in eyes with persistent SHRM than in eyes with SHRM that resolved ( @ % vs. @ % ; P < @ ) .


Among eyes with detailed evaluation of SHRM at weeks @ ( n = @ ) and @ ( n = @ ) , mean VA letter score was @ ( standard error -LSB- SE -RSB- , @ ) , @ ( SE , @ ) , @ ( SE , @ ) , and @ ( SE , @ ) when SHRM was absent , present outside the central @ mm ( @ ) , present within the central @ mm ( @ ) but not the foveal center , or present at the foveal center ( P = @ ) , respectively .


When SHRM was present , the median maximum height under the fovea , within the central @ mm ( @ ) including the fovea and anywhere within the scan , was @ m , @ m , and @ m , respectively .


Visual acuity was decreased with greater SHRM height and width ( P < @ ) .


In eyes with neovascular age-related macular degeneration ( AMD ) , SHRM is common and often persists after anti-vascular endothelial growth factor treatment .


At @ years , eyes with scar were more likely to have SHRM than other eyes .


Greater SHRM dimensions were associated with worse VA. .


In eyes with neovascular AMD , SHRM is an important morphologic biomarker .


A phase @ randomized clinical trial was designed to test whether bardoxolone methyl , a nuclear factor erythroid-@-related factor @ ( Nrf@ ) activator , slows progression to end-stage renal disease in patients with stage @ chronic kidney disease and type @ diabetes mellitus .


The trial was terminated because of an increase in heart failure in the bardoxolone methyl group ; many of the events were clinically associated with fluid retention .


We randomized @,@ patients with type @ diabetes mellitus ( T@DM ) and stage @ chronic kidney disease ( CKD ) ( estimated glomerular filtration rate @ to < @ mL min ( -@ ) @ m ( -@ ) ) to once-daily bardoxolone methyl ( @ mg ) or placebo .


We used classification and regression tree analysis to identify baseline factors predictive of heart failure or fluid overload events .


Elevated baseline B-type natriuretic peptide and previous hospitalization for heart failure were identified as predictors of heart failure events ; bardoxolone methyl increased the risk of heart failure by @ % in patients with these risk factors .


For patients without these baseline characteristics , the risk for heart failure events among bardoxolone methyl - and placebo-treated patients was similar ( @ % ) .


The same risk factors were also identified as predictors of fluid overload and appeared to be related to other serious adverse events .


Bardoxolone methyl contributed to events related to heart failure and/or fluid overload in a subpopulation of susceptible patients with an increased risk for heart failure at baseline .


Careful selection of participants and vigilant monitoring of the study drug will be required in any future trials of bardoxolone methyl to mitigate the risk of heart failure and other serious adverse events .


Small studies suggest that low-dose dopamine or low-dose nesiritide may enhance decongestion and preserve renal function in patients with acute heart failure and renal dysfunction ; however , neither strategy has been rigorously tested .


To test the @ independent hypotheses that , compared with placebo , addition of low-dose dopamine ( @ g/kg/min ) or low-dose nesiritide ( @ g/kg/min without bolus ) to diuretic therapy will enhance decongestion and preserve renal function in patients with acute heart failure and renal dysfunction .


Multicenter , double-blind , placebo-controlled clinical trial ( Renal Optimization Strategies Evaluation -LSB- ROSE -RSB- ) of @ hospitalized patients with acute heart failure and renal dysfunction ( estimated glomerular filtration rate of @-@ mL/min/@ @ m@ ) , randomized within @ hours of admission .


Enrollment occurred from September @ to March @ across @ sites in North America .


Participants were randomized in an open , @:@ allocation ratio to the dopamine or nesiritide strategy .


Within each strategy , participants were randomized in a double-blind , @:@ ratio to active treatment or placebo .


The dopamine ( n = @ ) and nesiritide ( n = @ ) groups were independently compared with the pooled placebo group ( n = @ ) .


Coprimary end points included @-hour cumulative urine volume ( decongestion end point ) and the change in serum cystatin C from enrollment to @ hours ( renal function end point ) .


Compared with placebo , low-dose dopamine had no significant effect on @-hour cumulative urine volume ( dopamine , @ mL ; @ % CI , @-@ vs placebo , @ mL ; @ % CI , @-@ ; difference , @ mL ; @ % CI , -@ to @ mL ; P = @ ) or on the change in cystatin C level ( dopamine , @ mg/L ; @ % CI , @-@ @ vs placebo , @ mg/L ; @ % CI , @-@ @ ; difference , @ ; @ % CI , -@ to @ ; P = @ ) .


Similarly , low-dose nesiritide had no significant effect on @-hour cumulative urine volume ( nesiritide , @ mL ; @ % CI , @-@ vs placebo , @ mL ; @ % CI , @-@ ; difference , @ mL ; @ % CI , -@ to @ mL ; P = @ ) or on the change in cystatin C level ( nesiritide , @ mg/L ; @ % CI , @-@ @ vs placebo , @ mg/L ; @ % CI , @-@ @ ; difference , -@ ; @ % CI , -@ to @ ; P = @ ) .


Compared with placebo , there was no effect of low-dose dopamine or nesiritide on secondary end points reflective of decongestion , renal function , or clinical outcomes .


In participants with acute heart failure and renal dysfunction , neither low-dose dopamine nor low-dose nesiritide enhanced decongestion or improved renal function when added to diuretic therapy .


The administration of statins seems to be a promising new avenue in the treatment of patients suffering from major depressive disorder ( MDD ) , though patients suffering from severe MDD remain unstudied in this respect .


The aim of the present study was therefore to investigate , in a randomized double-blind clinical trial , the influence of adjuvant atorvastatin on symptoms of depression in patients with MDD .


A total of @ patients suffering from MDD ( mean age : @ years ; @ % males ) received a standard medication of @ mg/d citalopram .


Next , patients were randomly assigned either to the atorvastatin group ( @ mg/d ) or to the placebo group .


Blood lipid values were assessed at baseline and on completion of the study @ weeks later .


Experts rated depressive symptoms via Hamilton Depression Rating Scales ( HDRS ) at baseline and @ , @ and @ weeks later .


HDRS scores decreased over time ; the significant Time by Group interaction showed that symptoms of depression decreased more in the atorvastatin than in the placebo group .


Compared to the placebo group , in the atorvastatin group cholesterol , triglyceride , and Low Density Lipids ( LDL ) significantly decreased , and High Density Lipids ( HDL ) significantly increased over time .


HDRS scores and blood lipid values were generally not associated .


The pattern of results suggests that adjuvant atorvastatin favorably influences symptoms of depression among patients with severe MDD .


Given that after @ weeks of monotherapy and adjuvant atorvastatin patients were still moderately to severely depressed , more powerful treatment algorithms such as augmentation and change of medication are highly recommended .


To compare measurement properties of the P@ pain scale , Western Ontario and McMaster Universities Arthritis Index pain subscale ( WOMAC-pain ) , and Intermittent and Constant Osteoarthritis Pain ( ICOAP ) measure in patients with knee osteoarthritis ( OA ) .


A secondary analysis from a randomized controlled trial included participants ( n = @ ) with knee OA that were consulting with a surgeon regarding knee arthroplasty .


They completed pain measures ( P@ , WOMAC-pain , ICOAP ) and WOMAC-function subscale ( WOMAC-function ) at baseline and @ weeks .


Measurement properties assessed in various subgroups included floor/ceiling effects , test-retest reliability using intraclass correlation coefficients ( ICC@ ,@ ) , internal consistency using Cronbach 's , factorial structure of each pain measure combined with WOMAC-function using principal component analysis , and responsiveness using standardized response mean ( SRM ) .


P@ had low floor and ceiling effects ( < @ % ) .


P@ test-retest reliability ( ICC@ ,@ = @ ) , internal consistency ( Chronbach 's = @ ) , and responsiveness ( SRM = @ ) were similar to the values for WOMAC-pain and ICOAP .


Factorial structure of P@ and ICOAP were separate from WOMAC-function items .


WOMAC-pain and WOMAC-function items loaded on similar factors .


ICOAP-constant subscale had a large floor effect ( @ % ) .


P@ should be used to measure pain in patients with knee OA .


It had acceptable measurement properties which is comparable to more widely used pain measures .


WOMAC-pain shared a factorial structure with WOMAC-function indicating these measures might be capturing the same construct , questioning its validity to measure pain separately from function .


ICOAP had acceptable properties .


More work should compare pain measures in less severely affected OA populations .


Individuals with a history of recurrent depression have a high risk of repeated depressive relapse or recurrence .


Maintenance antidepressants for at least @ years is the current recommended treatment , but many individuals are interested in alternatives to medication .


Mindfulness-based cognitive therapy ( MBCT ) has been shown to reduce risk of relapse or recurrence compared with usual care , but has not yet been compared with maintenance antidepressant treatment in a definitive trial .


We aimed to see whether MBCT with support to taper or discontinue antidepressant treatment ( MBCT-TS ) was superior to maintenance antidepressants for prevention of depressive relapse or recurrence over @ months .


In this single-blind , parallel , group randomised controlled trial ( PREVENT ) , we recruited adult patients with three or more previous major depressive episodes and on a therapeutic dose of maintenance antidepressants , from primary care general practices in urban and rural settings in the UK .


Participants were randomly assigned to either MBCT-TS or maintenance antidepressants ( in a @:@ ratio ) with a computer-generated random number sequence with stratification by centre and symptomatic status .


Participants were aware of treatment allocation and research assessors were masked to treatment allocation .


The primary outcome was time to relapse or recurrence of depression , with patients followed up at five separate intervals during the @-month study period .


The primary analysis was based on the principle of intention to treat .


The trial is registered with Current Controlled Trials , ISRCTN@ .


Between March @ , @ , and Oct @ , @ , we assessed @ participants for eligibility and recruited @ patients from @ general practices .


@ patients were randomly assigned to MBCT-TS and @ to maintenance antidepressants .


The time to relapse or recurrence of depression did not differ between MBCT-TS and maintenance antidepressants over @ months ( hazard ratio @ , @ % CI @-@ ; p = @ ) , nor did the number of serious adverse events .


Five adverse events were reported , including two deaths , in each of the MBCT-TS and maintenance antidepressants groups .


No adverse events were attributable to the interventions or the trial .


We found no evidence that MBCT-TS is superior to maintenance antidepressant treatment for the prevention of depressive relapse in individuals at risk for depressive relapse or recurrence .


Both treatments were associated with enduring positive outcomes in terms of relapse or recurrence , residual depressive symptoms , and quality of life .


To compare the effects of exergaming with conventional weight-shift training on balance function in patients with chronic stroke .


Single-blind randomized controlled trial .


Medical center .


Patients ( N = @ ) with chronic stroke and balance deficits .


Twelve weeks of Wii Fit training or conventional weight-shift training .


Static balance was assessed using posturography .


We recorded the stability index and percentage of weight bearing on the affected leg in @ positions .


We also used the timed Up and Go and forward reach tests for dynamic balance evaluation , Falls Efficacy Scale-International for fear of falling assessment , and Physical Activity Enjoyment Scale for estimating the enjoyment of training .


The exergaming group showed more improvement in stability index than the control group in head straight with eyes open while standing on a foam surface , eyes closed while standing on a solid surface with head turned @ to the left , and eyes closed while standing on a solid surface with head turned up positions ( time-group interaction P = @ , @ , and @ , respectively ) ; however , the effects were not maintained .


At @-month follow-up , the control group showed more improvement in weight-bearing symmetry in the head straight with eyes open while standing on a solid surface position than the exergaming group ( time-group interaction P = @ ) .


Both groups showed improvement in the timed Up and Go test , forward reach test , and fear of falling .


The improvement in fear of falling was not maintained .


The exergaming group enjoyed training more than the control group ( P = @ ) .


Exergaming is enjoyable and effective for patients with chronic stroke .


The aim of this study was to compare the recurrence rates for primary pterygia after fibrin glue-assisted conjunctival autograft ( CAG ) versus conjunctivolimbal autograft ( CLAG ) transplantation , using a technique of limited conjunctival resection and Tenon extended removal .


In this comparative case series , @ eyes of @ patients with primary nasal pterygium were included .


Patients were randomized into @ groups to undergo fibrin glue-assisted CAG ( group @ , @ eyes ) or fibrin glue-assisted CLAG ( group @ , @ eyes ) following excision of pterygium .


The surgical technique used in all patients involved limited conjunctival resection combined with extensive removal of the Tenon capsule up to the caruncle medially and also @ mm beyond the inferior and superior free edges of the conjunctiva .


The main outcome measure studied was the absence or presence of recurrence .


There was @ % recurrence rate in both groups after a mean follow-up of @ weeks ( range , @-@ weeks ) with all eyes completing at least @-year of follow-up .


Fibrin glue-assisted CAG and CLAG using the technique of conjunctival resection and Tenon extended removal were equally efficacious in terms of preventing recurrences in patients with primary pterygia in our series .


Acellular pertussis vaccines do not control pertussis .


A new approach to offer protection to infants is necessary .


BPZE@ , a genetically modified Bordetella pertussis strain , was developed as a live attenuated nasal pertussis vaccine by genetically eliminating or detoxifying @ toxins .


We performed a double-blind , placebo-controlled , dose-escalating study of BPZE@ given intranasally for the first time to human volunteers , the first trial of a live attenuated bacterial vaccine specifically designed for the respiratory tract .


@ subjects per dose group received @ , @ or @ colony-forming units as droplets with half of the dose in each nostril .


@ controls received the diluent .


Local and systemic safety and immune responses were assessed during @ months , and nasopharyngeal colonization with BPZE@ was determined with repeated cultures during the first @ weeks after vaccination .


Colonization was seen in one subject in the low dose , one in the medium dose and five in the high dose group .


Significant increases in immune responses against pertussis antigens were seen in all colonized subjects .


There was one serious adverse event not related to the vaccine .


Other adverse events were trivial and occurred with similar frequency in the placebo and vaccine groups .


BPZE@ is safe in healthy adults and able to transiently colonize the nasopharynx .


It induces immune responses in all colonized individuals .


BPZE@ can thus undergo further clinical development , including dose optimization and trials in younger age groups .


This study aimed to evaluate the internal consistency reliability and construct validity of the Fitzpatrick Skin Type Scale during radiation therapy in a cohort of women receiving treatment for breast cancer .


The assessment of the scale was performed as a nested study within a randomised controlled trial of two creams used for radiation therapy skin care for breast cancer patients .


The sample consisted of @ female patients undergoing radiation therapy for breast cancer .


Participants completed a modified version of the Fitzpatrick Skin Type Scale .


Internal consistency as measured by Cronbach 's alpha was @ , @ and @ for the Genetic Disposition , Sun Exposure and Tanning Habits subscales respectively .


Only the Sun Exposure subscale surpassed the @ cut-off , indicating good internal consistency .


Maximum likelihood factor analysis with promax rotation method confirmed the a priori factor structure for the Sun Exposure subscale as well as providing evidence of construct validity for this subscale .


Analysis for the other two subscales highlighted issues with internal reliability and construct validity suggesting that not all items on each subscale truly measure the intended trait .


The study findings support reliability and validity of the Sun Exposure subscale of the Fitzpatrick Skin Type Scale in a convenience sample of women receiving radiation therapy for cancer .


Despite limitations with two of the three subscales , this tool continues to be used in clinical practice .


Treatment impact on quality of life ( QoL ) informs treatment management decisions in advanced nonsquamous non-small-cell lung cancer ( NS NSCLC ) .


QoL outcomes from the phase III PointBreak trial are reported .


Chemonaive patients ( n = @ ) with stage IIIB/IV nonsquamous non-small-cell lung cancer and Eastern Cooperative Oncology Group performance status @ to @ were randomized ( @:@ ) to pemetrexed-carboplatin-bevacizumab ( pemetrexed arm ) or paclitaxel-carboplatin-bevacizumab ( paclitaxel arm ) .


Patients without progressive disease received maintenance pemetrexed-bevacizumab ( pemetrexed arm ) or bevacizumab ( paclitaxel arm ) .


QoL was assessed using Functional Assessment of Cancer Therapy ( FACT ) - General ( FACT-G ) , FACT-Lung ( FACT-L ) , and FACT/Gynecologic Oncology Group-Neurotoxicity ( FACT-Ntx ) instruments .


Subscale scores , total scores , and trial outcome indices were analyzed using linear mixed-effects models .


Post hoc analyses examined the association between baseline FACT scores and overall survival ( OS ) .


Mean score differences in change from baseline significantly favored the pemetrexed arm for the neurotoxicity subscale score , FACT-Ntx total scores , and FACT-Ntx trial outcome index .


They occurred at cycle @ ( p < @ ) and persisted through induction cycles @ to @ and six maintenance cycles .


Investigator-assessed , qualitative , drug-related differences in grade @ ( @ % versus @ % ) and grade @ ( @ % versus @ % ) sensory neuropathy and grade @/@ fatigue ( @ % versus @ % , p = @ ) were observed between the pemetrexed and paclitaxel arms .


Baseline FACT-G , FACT-L , and FACT-Ntx scores were significant prognostic factors for OS ( p < @ ) .


Randomized patients reported similar changes in QoL , except for less change from baseline in neurotoxicity on the pemetrexed arm ; investigators reported greater neurotoxicity on the paclitaxel arm and greater fatigue on the pemetrexed arm .


Higher baseline FACT scores were favorable prognostic factors for OS .


Initiation of epidural anesthesia with long-lasting local anesthetics consumes a significant amount of time , which could be problematic in busy obstetric anesthesia suites .


We have hypothesized that a combination of articaine and ropivacaine provides faster onset and even an early recovery of sensory-motor block characteristics .


Sixty term parturients scheduled to have elective cesarean section were randomly allocated into three groups to receive either @ mL @ % articaine ( Group A ) , @ mL @ % articaine + @ mL @ % ropivacaine ( Group AR ) or @ mL @ % ropivacaine ( Group R ) via lumbar epidural catheter .


The onset time of sensory block to T@ , T@ and maximum sensory block level , time to two segments regression from maximum sensory block level , onset time and duration of motor block were all recorded .


Intraoperative and postoperative additional analgesic requirements were also recorded .


Demographic data were similar .


The onset times of sensorial block to T@ and T@ were significantly shorter in Groups A and AR in comparison with Group R ( p < @ ) .


The onset times of motor block were similar in all groups , but a more intense motor block was observed in Group R ( p < @ ) .


Two segments regression time and motor block durations were significantly shorter in Groups A and AR in comparison with Group R ( p < @ ) .


Intraoperative supplementary analgesic requirements were higher in Group A than in the other two groups ( p < @ ) .


A combination of @ % articaine and @ % ropivacaine for epidural anesthesia in a cesarean section should be preferred over epidural @ % ropivacaine alone .


Few clinical studies involving cigarettes have provided a comprehensive picture of smoke exposure , test article characterization , and insights into sensory properties combined .


The purpose of these pilot studies was to determine whether cigarettes with different levels of nicotine but similar tar levels would affect sensory experience or smoking behavior so as to significantly alter levels of selected biomarkers of exposure ( BOE ) .


In @ confined , double-blind studies , @ adult smokers switched from Marlboro Gold cigarettes at baseline to either @ of @ lower nicotine cigarettes or @ of @ higher nicotine cigarettes and then to the other cigarette after @ days .


Urinary excretion of exposure biomarkers ( nicotine equivalents -LSB- NE -RSB- , total and free @ - ( methylnitrosamino ) -@ - ( @-pyridyl ) -@ - butanol -LSB- NNAL -RSB- , @-hydroxypyrene , and @-hydroxypropyl mercapturic acid ) as well as carboxyhemoglobin and plasma cotinine were measured at baseline , Day @ , and Day @ .


Daily cigarette consumption was monitored and sensory characteristics were rated for each cigarette .


With higher nicotine yield , urine NE , urine total NNAL , and plasma cotinine increased while nonnicotine BOE decreased without changes in cigarette consumption .


In contrast , with lower nicotine yield , urine NE , urine total NNAL , and plasma cotinine dropped while nonnicotine BOE and cigarettes per day increased .


Higher nicotine cigarettes were rated harsher and stronger than at baseline while lower nicotine cigarettes were less strong .


All @ test cigarettes were highly disliked .


These studies demonstrate that abrupt increases or decreases in nicotine and the resulting sensory changes impact BOE through changes in intensity or frequency of smoking .


To compare the measurements and growth rates of geographic atrophy ( GA ) secondary to age-related macular degeneration ( AMD ) obtained using different imaging modalities .


Thirty patients with AMD and GA measuring from @ mm to @ mm based on spectral-domain optical coherence tomography ( SD-OCT ) fundus imaging were enrolled .


Imaging was performed at baseline and at follow-up months @ , @ , @ , and @ , including autofluorescence ( AF ) imaging with a fundus camera-based flash system ( TRC-@DX ; Topcon Medical Systems , Oakland , NJ ; AF excitation : @-@ nm ; detection : @-@ nm ) , AF and fluorescein angiography ( FA ) imaging with a confocal scanning laser ophthalmoscopy ( SLO ) system ( Spectralis ; Heidelberg Engineering , Heidelberg , Germany ; AF excitation : @ nm ; detection : > @ nm ) , and SD-OCT en face imaging ( Cirrus ; Carl Zeiss Meditec , Dublin , CA ) .


Average baseline square root measurements and enlargement rates of square root areas appeared similar across all modalities ; @ mm was the largest difference between any pair of measurement means .


The intraclass correlation coefficients ( ICC ) were essentially equal to @ for all comparisons of area measurements but were lower for growth rates than area measurements .


Comparison of @-week average enlargement rates showed no significant difference between the SLO AF image and enhanced SD-OCT en face image ( mean difference : @ mm ; SD : @ ; P = @ ) .


Agreement among all imaging modalities in measuring the areas of GA at baseline diminished when the growth rates of GA were compared over @ weeks , likely because each imaging technique identifies different anatomic features along the border of GA , which may appear similar but change at different rates .


Red blood cell ( RBC ) transfusion is frequently used to treat women with acute anaemia after postpartum haemorrhage .


We aimed to assess the economic consequences of red blood cell transfusion compared to non-intervention in these women .


A trial-based cost-effectiveness analysis was performed alongside the Well-Being of Obstetric patients on Minimal Blood transfusions ( WOMB ) trial .


Women with acute anaemia -LSB- Hb @-@g / dl ( @-@mm ) -RSB- after postpartum haemorrhage , without severe anaemic symptoms , were randomly allocated to RBC transfusion or non-intervention .


Primary outcome of the trial was physical fatigue ( Multidimensional Fatigue Inventory , scale @-@ ; @ represents maximal fatigue ) .


Total costs per arm were calculated using a hospital perspective with a @weeks time horizon .


Per woman , mean costs in the RBC transfusion arm ( n = @ ) were @ compared to @ in the non-intervention arm ( n = @ ; P = @ ) .


The @ % difference in costs between study arms predominantly originated from costs of RBC units , as costs of RBC units were six times higher in the RBC transfusion arm .


RBC transfusion led to a small improvement in physical fatigue of @ points per day ; thus , the costs to improve the physical fatigue score with one point would be @ .


In women with acute anaemia after postpartum haemorrhage ( PPH ) , RBC transfusion is on average @ more expensive per woman than non-intervention , with only a small gain in HRQoL after RBC transfusion .


Taking both clinical and economic consequences into account , implementation of a non-intervention policy seems justified .


Regular endotracheal tube cuff monitoring may prevent silent aspiration .


We hypothesised that active management of the cuff of the tracheal tube during deep hypothermic cardiac arrest would reduce silent subglottic aspiration .


We also determined to study its effect on postoperative mechanical ventilation and the incidence of postoperative positive tracheal cultures .


A randomised clinical trial .


The study was conducted in a University Teaching Hospital from September @ to November @ .


Twenty-four patients undergoing elective pulmonary endarterectomy were included in the study .


After induction of general anaesthesia and tracheal intubation , the cuff of the tracheal tube was inflated to @cmH@O .


Following this , @ml of methylene blue dye diluted in @ml of physiological saline was injected into the hypopharynx .


Patients were randomly assigned to active cuff management during cooling and warming ( where cuff pressure was monitored and the cuff was reinflated if it dropped below @cmH@O , or deflated if pressure exceeded @cmH@O ) or passive monitoring ( where cuff pressure was monitored but volume was not altered ) .


Before weaning from cardiopulmonary bypass , fibreoptic bronchoscopy was performed .


Silent aspiration was then diagnosed if blue dye was seen in the trachea below the cuff of the tube .


The primary aim of this study was to determine the incidence of silent aspiration .


Secondary outcomes included duration of postoperative mechanical ventilation of the lungs and incidence of positive culture of tracheal aspirate .


Active cuff management patients were younger than controls ( @ vs. @ years , P = @ ) , but otherwise the two groups were similar .


The primary endpoint was reached because we showed that silent aspiration was significantly less frequent in the study group ( @/@ vs. @/@ patients , P = @ ) .


Significantly lower intracuff pressures were measured in the control group patients at several timepoints during cooling , just before hypothermic arrest and at all timepoints during rewarming .


We recommend that the cuff of the tracheal tube should be checked regularly during surgery under deep hypothermia , and the cuff pressure adjusted as required .


Cetuximab is a chimeric monoclonal antibody against the epidermal growth factor receptor ( EGFR ) .


Skin reactions are the most common side effects of cetuximab .


Rhagades of the tips of the fingers and toes , the heels and especially the interphalangeal joints are one of the most frightening and painful dermatological side effects that may develop from EGFR-inhibitor therapy .


Rhagades are characterized by pain , severe tenderness and poor healing response .


They are challenging to treat .


Thus , rhagades often poses the most significant threat to the quality of life ( QoL ) for these patients .


Ethyl-@-cyanoacrylate ( ECA ) , an ethyl ester of the @-cyano-@-propenoic acid , is often used as adhesive in a variety of different work settings in industry , i.e. as a component in nail-care products such as nail glue .


In addition , ECA is used for various medical indications , such as for liquid bandages and for suture-less surgery .


Wound healing can be accelerated with ECA .


The purpose of the SUPPORT trial is to investigate the efficacy of ECA for the treatment of cetuximab-induced rhagades and to assess the clinical usefulness of the SUPO score , a new classification system for rhagades induced by EGFR-inhibitor therapy .


The SUPPORT trial is an open-label , prospective , randomized , national multicenter intervention study to evaluate the effectiveness of ECA versus the standard treatment of each institution on the pain intensity and QoL in patients with locally advanced head and neck cancer suffering from painful cetuximab-induced rhagades during radioimmunotherapy .


Primary endpoint is the assessment of the pain intensity @ hours after application of ECA or the standard treatment quantified by the visual analogue scale ( VAS ) .


Secondary endpoints are the evaluation of QoL assessed by the EORTC-QoL-C@ questionnaire and the Dermatological Life Quality Index ( DLQI ) .


During treatment with EGFR inhibitors it is necessary to recognize and manage side effects promptly to assure better patient QoL .


The SUPPORT trial is the first randomized clinical trial evaluating a new treatment option for painful cetuximab-induced rhagades .


Furthermore , the new SUPO score will be prospectively assessed in terms of clinical usefulness for classification of EGFR inhibitor-induced rhagades .


The aim of this study was to characterize cardiac reactivity measures , heart rate ( HR ) , and heart rate variability ( HRV ) , following acute intravenous ( IV ) alcohol administration and their association with subjective responses in social drinkers .


Twenty-four subjects ( @ females ) received IV alcohol infusions to attain and clamp the breath alcohol concentration ( BrAC ) at @ mg % or placebo in separate sessions .


Serial @-minute cardiac recordings at baseline and during the infusion were analyzed to obtain frequency and time domain cardiac measures .


Self-reported subjective perceptions were also obtained at the same time points .


HR showed significant decreases from baseline , while the HRV measure pNN@ showed steady increases during the ascending phase of alcohol infusion .


HR was inversely correlated with pNN@ across time and treatment .


There was a significant association of HR with subjective feelings of high , intoxication , feeling drug effects , and liking drug effects across time during the ascending phase .


Acute IV alcohol resulted in decreases in HR and increases in HRV consistent with autonomic parasympathetic activation .


The association of these changes with subjective responses suggests that cardiac reactivity may serve as a physiological marker of subjective alcohol effects .


This study broadens the understanding of acute cardiovascular effects of alcohol and clinically significant cardiac conditions such as arrhythmia and cardiomyopathy associated with chronic alcohol drinking .


A @-h phase advance model of insomnia was used to evaluate the efficacy of lorediplon , a new non-benzodiazepine hypnotic .


Thirty-five male , healthy subjects were included in a five-way randomized cross-over study .


During each of the periods , sleep was recorded , and residual effects were measured .


All subjects received lorediplon @ , @ , and @ mg , placebo , and zolpidem @ mg ( i.e. , active control ) .


Polysomnographic evaluation revealed that lorediplon ( @ and @ mg ) significantly decreased wake after sleep onset ( WASO ) and increased total sleep time .


Analysis by quarters of the night showed a progressive increasing effectiveness of lorediplon @ mg across the first three quarters .


Lorediplon increased non-rapid eye movement slow wave sleep and stage N@ sleep in the second and third quarters .


The magnitude of these effects was dose related , with minimal effects seen with @ mg .


No residual effects were observed @ h post dose .


Lorediplon demonstrated a dose-dependent improvement in sleep , whereas zolpidem showed a more sustained WASO effect .


No next-day hangover effects were observed .


These sleep effects are also consistent with the pharmacokinetic profile of lorediplon .


These results warrant clinical trials in patients with insomnia .


Whether adiposity indicators other than body mass index ( BMI ) should be used in studies of childhood asthma is largely unknown .


The role of atopy in `` obese asthma '' is also unclear .


To examine the relationship among adiposity indicators , asthma , and atopy in Puerto Rican children , and to assess whether atopy mediates the obesity-asthma association .


In a study of Puerto Rican children with ( n = @ ) and without ( n = @ ) asthma , we measured BMI , percent of body fat , waist circumference , and waist-to-hip ratio .


The outcomes studied included asthma , lung function , measures of atopy , and , among cases , indicators of asthma severity or control .


We performed mediation analysis to assess the contribution of atopy to the relationship between adiposity and asthma .


BMI , percent of body fat , and waist circumference were associated with increased odds of asthma .


Among cases , all @ measures were generally associated with lung function , asthma severity/control , and atopy ; however , there were differences depending on the adiposity indicator analyzed .


Atopy considerably mediated the adiposity-asthma association in this population : allergic rhinitis accounted for @ % to @ % of the association with asthma , and sensitization to cockroach mediated @ % to @ % of the association with forced vital capacity and @ % to @ % of the association with emergency department visits for asthma .


Adiposity indicators are associated with asthma , asthma severity/control , and atopy in Puerto Rican children .


Atopy significantly mediates the effect of adiposity on asthma outcomes .


Longitudinal studies are needed to further investigate the causal role , if any , of adiposity distribution and atopy on `` obese asthma '' in childhood .


Preconception-initiated low-dose aspirin might positively affect pregnancy outcomes , but this possibility has not been adequately assessed .


Our aim was to investigate whether low-dose aspirin improved livebirth rates in women with one to two previous pregnancy losses .


In this multicentre , block-randomised , double-blind , placebo-controlled trial , women aged @-@ years who were attempting to become pregnant were recruited from four medical centres in the USA .


Participants were stratified by eligibility criteria -- the original stratum was restricted to women with one loss at less than @ weeks ' gestation during the previous year , whereas the expanded stratum included women with one to two previous losses , with no restrictions on gestational age or time of loss .


Women were block-randomised by centre and eligibility stratum in a @:@ ratio .


Preconception-initiated daily low-dose aspirin ( @ mg per day ) plus folic acid was compared with placebo plus folic acid for up to six menstrual cycles ; for women who conceived , study treatment continued until @ weeks ' gestation .


Participants , trial staff , and investigators were masked to the assigned treatment .


The primary outcome was livebirth rate , which was analysed by intention to treat .


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


Overall , @ women were recruited and randomly assigned between June @ , @ , and July @ , @ , @ of whom completed the trial and were included in the analysis ( @ in the low-dose aspirin group and @ in the placebo group ) .


@ ( @ % ) women in the low-dose aspirin group had livebirths , compared with @ ( @ % ) in the placebo group ( p = @ ; absolute difference in livebirth rate @ % -LSB- @ % CI -@ to @ -RSB- ) .


Pregnancy loss occurred in @ ( @ % ) women in the low-dose aspirin group , compared with @ ( @ % ) women in the placebo group ( p = @ ) .


In the original stratum , @ ( @ % ) of @ women in the low-dose aspirin group had livebirths , compared with @ ( @ % ) of @ in the placebo group ( p = @ ; absolute difference in livebirth rate @ % -LSB- @ to @ -RSB- ) .


In the expanded stratum , @ ( @ % ) of @ women in the low-dose aspirin group and @ ( @ % ) of @ in the placebo group had livebirths ( p = @ ; absolute difference in livebirth rate @ % -LSB- -@ to @ -RSB- ) .


Major adverse events were similar between treatment groups .


Low-dose aspirin was associated with increased vaginal bleeding , but this adverse event was not associated with pregnancy loss .


Preconception-initiated low-dose aspirin was not significantly associated with livebirth or pregnancy loss in women with one to two previous losses .


However , higher livebirth rates were seen in women with a single documented loss at less than @ weeks ' gestation during the previous year .


Low-dose aspirin is not recommended for the prevention of pregnancy loss .


To evaluate intereye corneal asymmetry in Pentacam ( Oculus Optikgerte GmbH , Wetzlar , Germany ) indices as a diagnostic method between normal patients and patients with keratoconus .


A retrospective , observational case series of @ healthy , @ indeterminate , and @ patients with keratoconus classified by Pentacam ectasia detection indices , randomized to analysis and validation datasets .


Intereye asymmetry in @ Scheimpflug tomography corneal descriptors was calculated and compared to develop diagnostic models .


Intereye asymmetry was not correlated with anisometropia in healthy controls but was correlated with the ectasia grade of the worse eye in patients with keratoconus .


Patients with keratoconus had significantly greater intereye asymmetry in all descriptors except for relational thickness indices .


Intereye asymmetry in front elevation at the thinnest corneal location afforded the single highest diagnostic performance ( @ % sensitivity and @ % specificity ) , whereas the best multivariate model combining intereye asymmetry in anterior and posterior keratometry , corneal thickness , and front and back elevation at the thinnest point provided @ % sensitivity and @ % specificity .


Multivariate models upheld their performance in the validation dataset .


Most ( more than @ % ) indeterminate patients , according to conventional Pentacam analysis , showed within-normal-range corneal asymmetry .


Healthy corneas are markedly symmetric irrespective of anisometropia , but corneal asymmetry analysis does not provide sufficient sensitivity to be used alone for detecting keratoconus .


However , its remarkable specificity suggests that it could be used combined with conventional single cornea Pentacam analysis to reduce the false-positive rate or in dubious cases .


To determine effects of Argentine tango on motor and non-motor manifestations of Parkinson 's disease .


Randomized control trial .


Forty patients with idiopathic Parkinson 's disease .


Movement disorder clinic and dance studio .


Two randomized groups : group ( N = @ ) with @ partnered tango classes , and control self-directed exercise group ( N = @ ) .


The primary outcome was overall motor severity .


Secondary outcomes included other motor measures , balance , cognition , fatigue , apathy , depression and quality of life .


On the primary intention-to-treat analysis there was no difference in motor severity between groups MDS-UPDRS-@ ( @ vs@-point reduction , p = @ ) .


Patient-rated clinical global impression of change did not differ ( p = @ ) , however examiner rating improved in favor of tango ( p = @ ) .


Mini-BESTest improved in the tango group compared to controls ( @ vs. -@ , p = @ ) .


Among individual items , tango improved in both simple TUG time ( -@ s vs. @ , p = @ ) and TUG Dual Task score ( @ vs. -@ , p = @ ) , with borderline improvement in walk with pivot turns ( @ vs. -@ , p = @ ) .


MoCa ( @ vs. -@ , p = @ ) and FSS ( -@ vs. @ , p = @ ) showed a non-significant trend toward improvement in the tango group .


Tango participants found the activity more enjoyable ( p < @ ) and felt more `` overall '' treatment satisfaction ( p < @ ) .


We found no significant differences in other outcomes or adverse events .


Argentine tango can improve balance , and functional mobility , and may have modest benefits upon cognition and fatigue in Parkinson 's disease .


These findings must be confirmed in longer-term trials explicitly powered for cognition and fatigue .


The aim of this preliminary clinical report was to evaluate and compare the clinical outcomes of immediate and early loaded mini-implants ( MIs ) supporting mandibular overdentures .


Thirty-six completely edentulous patients ( @ men and @ women ) complaining of insufficient retention of their mandibular dentures were randomly assigned to two groups .


Each patient received four MIs in the interforaminal area of the mandible using the nonsubmerged flapless surgical approach .


In group @ ( G@ ) , MIs were loaded with mandibular overdentures using the immediate loading protocol , while in group @ ( G@ ) , MIs were loaded with overdentures using the early loading protocol .


The cumulative survival rate was calculated using Kaplan-Meier analysis .


Peri-implant health indices ( Plaque Index/Bleeding Index ) , probing depths , and marginal bone levels were recorded for both groups after MI insertions and @ , @ , @ , and @ months thereafter .


The cumulative implant survival rates were @ % and @ % for G@ and G@ , respectively .


G@ recorded significantly higher Plaque Index , Bleeding Index , and probing depths than G@ after @ months , while other observation times demonstrated no significant difference between groups .


Most of the recorded marginal bone loss occurred in the first year , and no significant bone loss was noted in subsequent years .


After @ months , marginal bone loss was significantly higher in G@ compared to G@ , but no significant differences between groups were noted thereafter .


Within the limitations of this study 's research design and duration of follow-up outcome analyses , immediate and early loading protocols showed good clinical results with favorable peri-implant tissue response @ years after implant insertion .


Early loading of MIs supporting a mandibular overdenture appears to be preferable to immediate loading .


Gemigliptin is a novel dipeptidyl peptidase-@ ( DPP-@ ) inhibitor used in the treatment of type @ diabetes mellitus .


This study evaluated possible pharmacodynamic and pharmacokinetic interactions between gemigliptin and metformin and investigated their tolerability .


A randomized , open-label , multiple-dose , three-treatment , three-period , three-sequence crossover study was conducted in healthy male subjects .


Twenty-seven subjects received gemigliptin ( @mg once daily ) , metformin ( @,@ mg twice a day ) , or both drugs for @days per dosing period .


Blood samples were drawn over @h on the seventh day of each period for pharmacokinetic and pharmacodynamic evaluations , including plasma DPP-@ activity and total/active glucagon-like peptide-@ ( GLP-@ ) levels .


Meal tolerance tests were conducted for pharmacodynamic assessment on the eighth day .


Safety and tolerability were evaluated using adverse events , vital signs , ECGs , and clinical laboratory tests .


Coadministration of gemigliptin and metformin had no significant effect on the pharmacokinetics of gemigliptin or metformin .


The inhibition of DPP-@ by gemigliptin was not affected by coadministration with metformin .


Co-therapy of gemigliptin and metformin showed additional effects by increasing plasma active GLP-@ concentrations and lowering serum glucose levels .


The plasma glucagon level was lower in co-therapy than with metformin monotherapy .


The coadministration of gemigliptin and metformin was well-tolerated without serious adverse events .


Coadministration of gemigliptin and metformin showed beneficial anti-diabetic effects without pharmacokinetic drug-drug interactions .


The purpose of the PROLUCA study is to investigate the efficacy of preoperative and early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer with special focus on exercise .


Using a @ x @ factorial design with continuous effect endpoint ( Maximal Oxygen Uptake ( VO@peak ) ) , @ patients with non-small cell lung cancer ( NSCLC ) stage I-IIIa referred for surgical resection will be randomly assigned to one of four groups : ( @ ) preoperative and early postoperative rehabilitation ( starting two weeks after surgery ) ; ( @ ) preoperative and late postoperative rehabilitation ( starting six weeks after surgery ) ; ( @ ) early postoperative rehabilitation alone ; ( @ ) today 's standard care which is postoperative rehabilitation initiated six weeks after surgery .


The preoperative rehabilitation program consists of an individually designed , @-minute home-based exercise program performed daily .


The postoperative rehabilitation program consists of a supervised group exercise program comprising cardiovascular and resistance training two-hour weekly for @ weeks combined with individual counseling .


The primary study endpoint is VO@peak and secondary endpoints include : Six-minute walk distance ( @MWD ) , one-repetition-maximum ( @RM ) , pulmonary function , patient-reported outcomes ( PROs ) on health-related quality of life ( HRQoL ) , symptoms and side effects of the cancer disease and the treatment of the disease , anxiety , depression , wellbeing , lifestyle , hospitalization time , sick leave , work status , postoperative complications ( up to @ days after surgery ) and survival .


Endpoints will be assessed at baseline , the day before surgery , pre-intervention , post-intervention , six months after surgery and one year after surgery .


The results of the PROLUCA study may potentially contribute to the identification of the optimal perioperative rehabilitation for operable lung cancer patients focusing on exercise initiated immediately after diagnosis and rehabilitation shortly after surgery .


To investigate the safety and feasibility of domestically made endoscopic stapling instrument in laparoscopic assisted rectal cancer resection ( Dixon ) .