There were no significant changes in the peak trunk flexion angle ( p = @ ) or peak trunk flexion velocity ( p = @ ) over time after the training ended .


The skill retention was present when either the prosthetic or nonprosthetic limb was perturbed .


There were side-to-side differences in the trunk flexion angle ( p = @ ) and trunk flexion velocity ( p = @ ) .


Perturbations of the prosthetic side resulted in larger trunk flexion and higher trunk flexion velocities .


Subjects prospectively reported decreased stumbles , semicontrolled falls , and uncontrolled falls .


These results indicate that task-specific fall prevention training is an effective rehabilitation method to reduce falls in persons with lower extremity transtibial amputations .


To explore the optimal postoperative nutritional support in elderly patients with gastric cancer .


One hundred and twenty elderly patients with gastric cancer undergoing radical gastrectomy were prospectively enrolled from January @ to March @ and randomly divided into total parenteral nutrition group ( TPN , n = @ ) , early total enteral nutrition group ( TEN , n = @ ) and enteral plus parenteral nutrition group ( EN+PN , n = @ ) .


Clinical charasteristics including treatment tolerance , nutritional indexes , immune indexes , time to first flatus , incidence of postoperative infection and anastomotic leakage , were analyzed and compared .


Treatment tolerance in EN+PN group ( @ % , @/@ ) was significantly higher than that in TPN group ( @ % , @/@ ) and TEN group ( @ % , @/@ ) ( both P < @ ) .


The nutritional indices , including prealbumin , albumin , transferrin , body mass index , and the incidence of anastomotic leakage were similar in the @ groups ( P > @ ) .


The immune indices , including CD@ , CD@ , CD@/CD@ , were significantly reduced after operation in each group .


However , they were significantly higher in EN+PN group and TEN group than those in TPN group ( both P < @ ) .


Furthermore , compared to the TPN group , the incidence of postoperative infection ( surgical site infection , pulmonary infection , abdominal infection ) was significantly lower and time to first flatus was significantly shorter in EN+PN group and TEN group .


Early enteral nutrition after gastric cancer surgery is safe , simple and feasible .


EN plus PN is the best way to administer postoperative nutritional support in elderly patients with gastric cancer .


Integrins are involved in tumour progression and metastasis , and differentially expressed on colorectal cancer ( CRC ) cells .


Abituzumab ( EMD @ ) , a humanised monoclonal antibody targeting integrin heterodimers , has demonstrated preclinical activity .


This trial was designed to assess the tolerability of different doses of abituzumab in combination with cetuximab and irinotecan ( phase I ) and explore the efficacy and tolerability of the combination versus that of cetuximab and irinotecan in patients with metastatic CRC ( mCRC ) ( phase II part ) .


Eligible patients had KRAS ( exon @ ) wild-type mCRC and had received prior oxaliplatin-containing therapy .


The trial comprised an initial safety run-in using abituzumab doses up to @ mg combined with a standard of care ( SoC : cetuximab plus irinotecan ) and a phase II part in which patients were randomised @ : @ : @ to receive abituzumab @ mg ( arm A ) or @ mg ( arm B ) every @ weeks combined with SoC , or SoC alone ( arm C ) .


The primary end point was investigator-assessed progression-free survival ( PFS ) .


Secondary end points included overall survival ( OS ) , response rate ( RR ) and tolerability .


Associations between tumour integrin expression and outcomes were also assessed .


Phase I showed that abituzumab doses up to @ mg were well tolerated in combination with SoC .


Seventy-three ( arm A ) , @ ( arm B ) and @ ( arm C ) patients were randomised to the phase II part .


Baseline characteristics were balanced .


PFS was similar in the three arms : arm A versus SoC , hazard ratio ( HR ) @ -LSB- @ % confidence interval ( CI ) @-@ @ -RSB- ; arm B versus SoC , HR @ ( @ % CI @-@ @ ) .


RRs were also similar .


A trend toward improved OS was observed : arm A versus SoC , HR @ ( @ % CI @-@ @ ) ; arm B versus SoC , HR @ ( @ % CI @-@ @ ) .


Grade @ treatment-emergent adverse events were observed in @ % , @ % and @ % of patients .


High tumour integrin v@ expression was associated with longer OS in arms A -LSB- HR @ ( @-@ @ ) -RSB- and B -LSB- HR @ ( @-@ @ ) -RSB- than in arm C.


The primary PFS end point was not met , although predefined exploratory biomarker analyses identified subgroups of patients in whom abituzumab may have benefit .


The tolerability of abituzumab combined with cetuximab and irinotecan was acceptable .


Further study is warranted .


CLINICALTRIALS.GOV IDENTIFIER : NCT@ .


To investigate whether remote ischemic conditioning ( RIC ) can attenuate ischemic reperfusion injury ( IRI ) in recipients after kidney transplantation using donation after cardiac death .


Forty-eight recipients referred for kidney transplantation were recruited .


The paired recipients who received the kidneys from the same donor were randomly assigned ( one received RIC and the other did not ) .


RIC was induced by three @-min cycles of brief repetitive ischemia and reperfusion by clamping the exposed external iliac artery .


Blood samples were withdrawn at hour @ , hour @ , days @-@ , day @ , and day @ to measure serum creatinine level and estimated glomerular filtration rate after transplantation .


Urine samples were collected at hours @ , @ , @ , and @ to measure urine neutrophil gelatinase-associated lipocalin after transplantation .


Renal tissues were obtained at @min for histologic changes after transplantation .


There were no significant differences in clinical characteristics of the recipients and donors between RIC and control groups .


The serum creatinine level was lower in the RIC group compared with that of the control group ( @h , days @-@ , P < @ ; other P > @ ) ; the estimated glomerular filtration rate was higher in the RIC group compared with that of the control group ( @h , days @-@ , P < @ ; other P > @ ) ; urine neutrophil gelatinase-associated lipocalin , an early marker of IRI , was lower in the RIC group at hours @ , @ , @ , and @ ( @ h , @h , P > @ ; @h , @h , P < @ ) compared with that of the control group .


The graft pathology showed no differences between RIC and control groups .


RIC enhanced the early recovery of renal function in recipients after kidneytransplantation .


Our results provide a novel potential approach to attenuate transplantation-associated IRI .


To assess the effect of bilateral ultrasound-guided transversus abdominis plane block with ropivacaine compared with placebo as part of a multimodal analgesic regimen .


A randomized , double-blind , placebo-controlled trial following the CONSORT criteria .


Hvidovre University Hospital .


Forty-six women scheduled for total abdominal hysterectomy .


Women received either ropivacaine @ % , @ mL ( n = @ ) or @ % saline , @ mL ( n = @ ) in the transversus abdominis plane on each side .


Primary outcome was the @-h postoperative morphine consumption .


Secondary outcomes were pain scores at rest and during coughing , postoperative nausea and vomiting at @ , @ , @ , @ , @ , and @ h , and time to first mobilization .


There was no difference in the mean @-h postoperative morphine consumption between the two groups ( p = @ ) .


The ropivacaine group had significantly lower median pain scores at @ h ( p = @ ) and @ h ( p = @ ) postoperatively at rest and at @ h ( p = @ ) during coughing .


There was no significant difference in other secondary outcomes .


There was no reduction in @-h morphine consumption when using an ultrasound-guided transversus abdominis plane block in women undergoing total abdominal hysterectomy .


As part of a multimodal regimen the transversus abdominis plane block showed some effect on pain scores at rest only in the early postoperative period .


To investigate the pharmacokinetics , safety , and analgesic efficacy of a novel topical formulation of lidocaine at insertion of an intrauterine device ( IUD ) .


Randomized controlled trial ; phase-I and phase-II studies .


University and public hospitals .


Women aged @ years who wanted to receive an IUD .


Four women were parous in phase I ; all in phase II were nulliparous .


A single , @-mL dose of lidocaine formulation ( SHACT ) was administered ( to the portio , cervix , and uterus ) with a specially designed applicator .


The phase-I study ( single-arm ) was designed for pharmacokinetic assessment ; the phase-II study ( randomized ) was intended for investigation of efficacy and safety .


From the phase-I study ( @ participants ) , mean pharmacokinetic values were : maximum plasma concentration : @ @ ng/mL ; time taken to reach maximum concentration : @ @ minutes ; and area under the concentration-time curve from @ to @ minutes : @ @ ng * h/mL .


Pain relief was observed with lidocaine vs. placebo in the phase-II study ( @ women , randomized ) .


Mean visual analog scale score for maximum pain during the first @ minutes after IUD insertion was @ % lower with lidocaine than with placebo ( @ @ vs. @ @ ) .


Pain intensity was also significantly lower in the lidocaine group at @ minutes .


On average , @ of @ patients will have less pain with lidocaine than with placebo .


Adverse events were similar in the placebo and lidocaine groups .


No serious adverse events were reported .


Lidocaine provides pain relief lasting for @-@ minutes for women undergoing IUD insertion , without any safety concerns .


Further studies of this lidocaine formulation , for IUD insertion and other clinical applications , are planned .


To compare laser in situ keratomileusis ( LASIK ) outcomes between @ femtosecond lasers for flap creation in the treatment of myopia up to @ year .


University eye clinic .


Prospective randomized eye-to-eye study .


Consecutive myopic patients were treated with wavefront-guided LASIK .


One eye had a flap created by the Intralase FS @ kHz femtosecond laser , and the fellow eye was treated with the Intralase iFS @ kHz femtosecond laser .


Eyes were randomized according to ocular dominance .


Evaluations included measurement of uncorrected distance visual acuity ( UDVA ) , corrected distance visual acuity , contrast sensitivity and wavefront aberrometry .


The study enrolled @ eyes of @ patients .


The mean preoperative spherical equivalent refraction was -@ diopters ( D ) @ ( SD ) and -@ @ D in the @ kHz group and @kHz group , respectively .


Patients preferred the @ kHz laser to the @ kHz laser intraoperatively ( @ % versus @ % ) ( P = @ ) .


One week postoperatively , UDVA was @/@ or better in @ % in the @ kHz group and @ % in the @ kHz group ; the difference was statistically significant ( P < @ ) .


At @ months , there were no significant differences in refractive outcomes or higher-order aberrations between the @ groups .


Flap creation with the @ kHz system and the @ kHz system resulted in excellent LASIK outcomes .


Intraoperatively , patients preferred the @ kHz system , which yielded better UDVA in the early postoperative period .


There were no significant differences at @ year between the @ laser systems .


To observe the clinical analgesic efficacy and the relation between clinical analgesic effect and duration of effect of two acupuncture methods of Longhu Jiaozhan ( fight of dragon and tiger , an acupuncture reinforcing and reducing manipulation characterized with nine counterclockwise and six clockwise rotations ) and even manipulations .


Sixty-two patients with primary dysmenorrhea were randomly divided into an observation group ( @ cases ) and a control group ( @ cases ) .


The observation group was applied with Longhu Jiaozhan manipulation , while the control group was applied with even manipulation .


Acupuncture treatment was given on both of the groups since onset of the pain .


The score of the visual analogue scale ( VAS ) of the @ groups was observed at different times .


And @ VAS values were recorded at the point right before acupuncture , needle remaining of @ min , @ min , @ min and @ min as well as and @ min , @ min , @ min after needle withdrawal .


Comparison was made on differences between the @ groups .


Comparison with the same group before acupuncture showed that the VAS difference of the time from needling remaining of @ min to @ min after acupuncture were all with statistic significance ( all P < @ ) .


The score of VAS of needle remaining for @ min and @ min of the observation group was without significant difference ( P > @ ) .


The score of VAS value of needle remaining for @ min and @ min of the control group was with significant difference ( P < @ ) .


Comparison of the VAS scores before the treatment and the scores of the @nd menstrual cycle were found with significant difference ( P < @ ) .


The VAS score of @nd menstrual cycle was ( @ + / - @ ) in the observation group , which was better than ( @ + / -@ ) in the control group ( P < @ ) .


Comparison of the VAS score of the two groups at @ min r emaining of the needle was without statistic significance between two groups ( P > @ ) .


However , the VAS impairment magnitude difference at that moment was with statistic significance ( P < @ ) .


From the time of needle remaining for @ min , @ min , @ min until @ min after needling , the differences of the VAS scores and impairment range were all with statistic significance ( all P < @ ) .


The effects of the two acupuncture techniques could both be maintained up to @ hours after needling .


Both methods of acupuncture have immediate and long-term analgesic effect in a certain degree on primary dysmenorrhea .


However , compared with the control group , the advantage of analgesic effect in the observation group is significantly superior .


@ min needling remaining can reach the best analgesic effect .


Our randomized controlled trial ( The BETTER Trial ) found that training a clinician to become a Prevention Practitioner ( PP ) in family practices improved chronic disease prevention and screening ( CDPS ) .


PPs were trained on CDPS and provided prevention prescriptions tailored to participating patients .


For this embedded qualitative study , we explored perceptions of this new role to understand the PP intervention .


We used grounded theory methodology and purposefully sampled participants involved in any capacity with the BETTER Trial .


Two physicians and one coordinator in each of two cities ( Toronto , Ontario and Edmonton , Alberta ) conducted eight individual semi-structured interviews and seven focus groups .


We used an interview guide and documented research activities through an audit trail , journals , field notes and memos .


We analyzed the data using the constant comparative method throughout open coding followed by theoretical coding .


A framework and process involving external and internal practice facilitation using the new role of PP was thought to impact CDPS .


The PP facilitated CDPS through on-going relationships with patients and practice team members .


Key components included : @ ) approaching CDPS in a comprehensive manner , @ ) an individualized and personalized approach at multiple levels , @ ) integrated continuity that included linking the patients and practices to CPDS resources , and @ ) adaptability to different practices and settings .


The BETTER framework and key components are described as impacting CDPS through a process that involved a new role , the PP .


The introduction of a novel role of a clinician within the primary care practice with skills in CDPS could appropriately address gaps in prevention and screening .


To observe the therapeutic effect of body acupuncture combined with auricular acupressure for treatment of menstrual headache of hyperactivity of `` liver fire '' .


A total of @ menstrual headache patients with hyperactivity of `` liver-fire '' were randomly divided into control group ( n = @ ) and treatment group ( n = @ ) .


Patients of the control group were treated by oral administration of Flunarizine Hydrochloride Capsules ( Sibelium , @ mg/time , twice daily ) for @ days beginning at the headache attack in the first menstrual cycle , and for two weeks ( except weekends ) in the second and third menstrual cycles .


Patients of the treatment group were treated by manual acupuncture stimulation of body acupoints Baihui ( GV @ ) , Fengchi ( GB @ ) , Sanyinjiao ( SP @ ) , Taichong ( LR @ ) , Xiaxi ( GB @ ) , Taiyang ( EX-HN @ ) , Hanyan ( GB @ ) , Xuanlu ( GB @ ) and Shuaigu ( GB @ ) beginning from the headache attack , and otopoint-pellet pressure of otopoints unilateral Endocrine , Ovaries , Shenmen , Cortex , Liver , Spleen and Kidney ( beginning @ days before menstrual onset ) and bilateral Shenmen , Nie , Liver , Gallbladder , Subcortex and Jiaogan during headache attack .


Clinical symptom scores were assessed according to the `` Guiding Principles for Clinical Research on New Chinese Herbal Drugs '' issued by the Chinese Ministry of Health .


After the treatment , of the @ and @ cases in the control and treatment groups , @ ( @ % ) and @ ( @ % ) were cured , @ ( @ % ) and @ ( @ % ) had a marked improvement , @ ( @ % ) and @ ( @ % ) were effective , @ ( @ % ) and @ ( @ % ) invalid , with the effective rates being @ % and @ % , respectively .


The curative effect of the treatment group was significantly better than that of the control group ( P < @ ) .


The symptom score and VAS score after the treatment and @ months post-treatment in the treatment group were significantly lower than those of the control group ( P < @ ) .


The headache scores and VAS scores were significantly reduced following the treatment and @ months after the treatment in both control and treatment groups ( P < @ ) .


After the treatment for @-@ therapeutic courses , the headache attack duration during menstruation was markedly and gradually shortened in both groups ( P < @ ) , and therapeutic effect of the treatment group was significantly better than that of the control group ( P < @ ) .


Body acupuncture combined with auricular acupressure treatment can effectively relieve menstrual headache in menstrual women with hyperactivity of `` liver fire '' .


Interleukin-@A is considered to be central to the pathogenesis of psoriasis .


We evaluated secukinumab , a fully human anti-interleukin-@A monoclonal antibody , in patients with moderate-to-severe plaque psoriasis .


In two phase @ , double-blind , @-week trials , ERASURE ( Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis ) and FIXTURE ( Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis ) , we randomly assigned @ patients ( in the ERASURE study ) and @ patients ( in the FIXTURE study ) to subcutaneous secukinumab at a dose of @ mg or @ mg ( administered once weekly for @ weeks , then every @ weeks ) , placebo , or ( in the FIXTURE study only ) etanercept at a dose of @ mg ( administered twice weekly for @ weeks , then once weekly ) .


The objective of each study was to show the superiority of secukinumab over placebo at week @ with respect to the proportion of patients who had a reduction of @ % or more from baseline in the psoriasis area-and-severity index score ( PASI @ ) and a score of @ ( clear ) or @ ( almost clear ) on a @-point modified investigator 's global assessment ( coprimary end points ) .


The proportion of patients who met the criterion for PASI @ at week @ was higher with each secukinumab dose than with placebo or etanercept : in the ERASURE study , the rates were @ % with @ mg of secukinumab , @ % with @ mg of secukinumab , and @ % with placebo ; in the FIXTURE study , the rates were @ % with @ mg of secukinumab , @ % with @ mg of secukinumab , @ % with etanercept , and @ % with placebo ( P < @ for each secukinumab dose vs. comparators ) .


The proportion of patients with a response of @ or @ on the modified investigator 's global assessment at week @ was higher with each secukinumab dose than with placebo or etanercept : in the ERASURE study , the rates were @ % with @ mg of secukinumab , @ % with @ mg of secukinumab , and @ % with placebo ; in the FIXTURE study , the rates were @ % with @ mg of secukinumab , @ % with @ mg of secukinumab , @ % with etanercept , and @ % with placebo ( P < @ for each secukinumab dose vs. comparators ) .


The rates of infection were higher with secukinumab than with placebo in both studies and were similar to those with etanercept .


Secukinumab was effective for psoriasis in two randomized trials , validating interleukin-@A as a therapeutic target .


( Funded by Novartis Pharmaceuticals ; ERASURE and FIXTURE ClinicalTrials.gov numbers , NCT@ and NCT@ , respectively . )


To compare the short term efficacy and tolerability of methylphenidate and atomoxetine in children with Attention deficit hyperactivity disorder ( ADHD ) .


Open label randomized parallel group clinical trial .


Child Guidance Clinic of a tertiary care hospital of Northern India from October @ to June @ .


@ patients ( age @-@ y ) with a diagnosis of ADHD receiving methylphenidate or atomoxetine .


Methylphenidate ( @-@ mg/kg/d ) or atomoxetine ( @-@ @ mg/kg/d ) for eight weeks .


Treatment response ( > @ % change in baseline Vanderbilt ADHD Diagnostic Parent Rating Scale ( VADPRS ) ; Vanderbilt ADHD Diagnostic Teacher Rating Scale ( VADTRS ) ; Clinical Global Impression Severity Scale ( CGI-S ) at eight weeks and adverse effects .


Treatment response was observed in @ % patients from methylphenidate group and @ % patients of atomoxetine group at an average dose of @ mg/kg/d and @ mg/kg/d , respectively .


The patients showed comparable improvement on VADPRS ( P = @ ) , VADTRS ( P = @ ) and CGI-S ( P = @ ) .


Weight loss was significantly higher in methylphenidate group ( -@ kg ; P = @ ) , and heart rate increase was observed at higher rate in atomoxetine group ( @ @ bpm ; P = @ ) .


Methylphenidate and atomoxetine are efficacious in Indian children with ADHD at lesser doses than previously used .


Their efficacy and tolerability are comparable .


TRIAL REGISTRATION NO. : CTRI/@/@ / @ .


There is not known if a viraemia post-oral polio vaccine ( OPV ) is detectable by modern molecular techniques .


Such viraemia could affect the performance of the real time-polymerase chain reaction ( PCR ) for non polio enterovirus ( EV ) detection , technique of growing clinical use for the study of febrile infants .


To determine viraemia post-first dose of OPV in healthy infants , by molecular techniques .


@ infants less than three months without previous VPO were randomized in @ groups : a control group with pre-vaccination blood sample ( BS ) , group @ BS at day @ , group @ BS at day @ , group @ , BS at day @ and group @ , BS at day @ post-vaccination .


Conventional and specific PCR for poliovirus and real time PCR for non polio EV were performed in BS and in OPV samples .


No genetic material of poliovirus was detected in any infant , while in @ of them ( @ % ) non polio EV was identified .


Real time PCR for EV did not amplify poliovirus from OPV samples .


Results suggest that no post VPO viraemia detectable by molecular methods exists .


Considering that real time PCR for EV does not allow to identify polio virus , no false positives of the test are expected as a result of a recent VPO vaccination .


We documented presence of non polio EV in blood of healthy asymptomatic infants .


An ageing population increases demand on health and social care .


New approaches are needed to shift care from hospital to community and general practice .


A predictive risk stratification tool ( Prism ) has been developed for general practice that estimates risk of an emergency hospital admission in the following year .


We present a protocol for the evaluation of Prism .


We will undertake a mixed methods progressive cluster-randomised trial .


Practices begin as controls , delivering usual care without Prism .


Practices will receive Prism and training randomly , and thereafter be able to use Prism with clinical and technical support .


We will compare costs , processes of care , satisfaction and patient outcomes at baseline , @ and @ months , using routine data and postal questionnaires .


We will assess technical performance by comparing predicted against actual emergency admissions .


Focus groups and interviews will be undertaken to understand how Prism is perceived and adopted by practitioners and policy makers .


We will model data using generalised linear models and survival analysis techniques to determine whether any differences exist between intervention and control groups .


We will take account of covariates and explanatory factors .


In the economic evaluation we will carry out a cost-effectiveness analysis to examine incremental cost per emergency admission to hospital avoided and will examine costs versus changes in primary and secondary outcomes in a cost-consequence analysis .


We will also examine changes in quality of life of patients across the risk spectrum .


We will record and transcribe focus groups and interviews and analyse them thematically .


We have received full ethical and R and D approvals for the study and Information Governance Review Panel ( IGRP ) permission for the use of routine data .


We will comply with the CONSORT guidelines and will disseminate the findings at national and international conferences and in peer-reviewed journals .


The proposed study will provide information on costs and effects of Prism ; how it is used in practice , barriers and facilitators to its implementation ; and its perceived value in supporting the management of patients with and at risk of developing chronic conditions .


The purpose of this study was to describe the longitudinal trajectories and bidirectional relationships of the physical-social and emotional functioning ( EF ) dimensions of positive aging and to identify their baseline characteristics .


Women age @ and older who enrolled in one or more Women 's Health Initiative clinical trials ( WHI CTs ) and who had positive aging indicators measured at baseline and years @ , @ , @ , and @ were included in these analyses ( N = @ ) .


Analytic strategies included latent class growth modeling to identify longitudinal trajectories and multinomial logistic regression to examine the effects of baseline predictors on these trajectories .


A five-trajectory model was chosen to best represent the data .


For Physical-Social Functioning ( PSF ) , trajectory groups included Low Maintainer ( @ % ) , Mid-Low Improver ( @ % ) , Medium Decliner ( @ % ) , Mid-High Maintainer ( @ % ) , and High Maintainer ( @ % ) ; for EF , trajectories included Low Maintainer ( @ % ) , Mid-Low Improver ( @ % ) , Medium Decliner ( @ % ) , Mid-High Maintainer ( @ % ) , and High Maintainer ( @ % ) .


Cross-classification of the groups of trajectories demonstrated that the impact of a high and stable EF on PSF might be greater than the reverse .


Low depression symptoms , low pain , and high social support were the most consistent predictors of high EF trajectories .


Aging women are heterogeneous in terms of positive aging indicators for up to @ years of follow-up .


Interventions aimed at promoting sustainable EF might have diffused effects on other domains of healthy aging .


To observe the clinical efficacy of warming Shen , enhancing Yang , invigorating qi , and nourishing blood method ( WSEYIQNBM ) combined artificial cycle therapy in treatment of premature ovarian failure ( POF ) patients of Shen yang deficiency syndrome ( SYDS ) .


Totally @ POF patients of SYDS were randomly assigned to the treatment group and the control group , @ in each group .


Patients in the treatment group were treated with WSEYIQNBM combined artificial cycle therapy , while those in the control group were treated with Western medicine artificial cycle therapy .


One month constituted @ course , a total of @ courses .


The menstruation and main symptoms were observed before and after treatment .


Serum levels of follicle stimulating hormone ( FSH ) , luteinizing hormone ( LH ) , and estradiol ( E@ ) were detected before and after treatment .


The total effective rate was @ % in the treatment group , higher than that of the control group ( @ % , P < @ ) .


Besides , better effect in improving Chinese medical symptoms was obtained in the treatment group ( P < @ ) .


POF patients ' serum hormone levels and clinical symptoms could be improved by WSEYIQNBM combined artificial cycle therapy .


Controlled laboratory study .


To determine the time course of dexamethasone sodium phosphate ( Dex-P ) during iontophoresis to underlying tissues using microdialysis .


In human participants , real-time information of Dex-P transdermal delivery during iontophoresis is unknown .


Sixty-four healthy male participants ( mean SD age , @ @ years ; height , @ @ cm ; mass , @ @ kg ; subcutaneous fat thickness , @ @ cm ) were randomly assigned into @ of @ groups : ( @ ) @-mA current , @-mm probe depth ; ( @ ) @-mA current , @-mm probe depth ; ( @ ) @-mA current , @-mm probe depth ; ( @ ) @-mA current , @-mm probe depth ; ( @ ) in vivo retrodialysis ; and ( @ ) skin perfusion flowmetry .


Microdialysis probes were used to assess the combined recovery ( Dex-total ) of Dex-P , dexamethasone , and its metabolite .


There was no difference in Dex-total between current intensities ( P = @ ) , but a greater amount of Dex-total was recovered superficially at @ mm compared to the @-mm depth ( P < @ ) .


Peak concentration mean SD values for the @ - and @-mA currents at @ mm were @ @ and @ @ g/mL , and at @ mm were @ @ and @ @ g/mL , respectively .


Peak skin perfusion was @ % @ % and @ % @ % at baseline for @ - and @-mA intensities , respectively .


Skin perfusion returned to baseline levels earlier during @-mA intensity at a @ mA min dose within the treatment , compared to @ mA at @ minutes posttreatment .


Transdermal delivery of Dex-P during iontophoresis was successfully measured in vivo through human skin .


Measurable concentrations of Dex-total were found regardless of current intensity .


Although current-induced vasodilation occurred , it did not significantly affect the tissue accumulation of Dex-total .


Smartphone technology presents a novel and promising opportunity to extend the reach of psychotherapeutic interventions by moving selected parts of the therapy into the real-life situations causing distress .


This randomised controlled trial will investigate the effects of a transdiagnostic , Internet-administered cognitive behavioural ( iCBT ) self-help program for anxiety , supplemented with a smartphone application .


The effect of added therapist support will also be studied .


One hundred and fifty participants meeting diagnostic criteria for social anxiety disorder and/or panic disorder will be evenly randomised to either one of three study groups : @ , smartphone-supplemented iCBT with therapist support ; @ , smartphone-supplemented iCBT without therapist support ; or @ , an active waiting list control group with delayed treatment .


Primary outcome measure will be the Generalised Anxiety Disorder @-item self-rating scale .


Secondary measures include other anxiety , depression and quality of life measures .


In addition to pre - and post-treatment measurements , the study includes two mid-treatment ( days @ and @ ) and two follow-up assessments ( @ and @ months ) to assess rapid and long-term effects .


To our knowledge , this is the first study to investigate the effectiveness of smartphone-supplemented iCBT for anxiety disorders .


Hence , the findings from this trial will constitute great advancements in the burgeoning and promising field of smartphone-administered psychological interventions .


Limitations are discussed .


Work with families and families at risk within the field of music therapy have been developing for the last decade .


To diminish risk for unhealthy child development , families with emotionally neglected children need help to improve their emotional communication and develop healthy parent-child interactions .


While some researchers have investigated the effect of music therapy on either the parent or the child , no study has investigated the effect of music therapy on the observed interaction between the parent and child within the field of child protection .


The purpose of this study was to investigate the effect of a dyadic music therapy intervention on observed parent-child interaction ( mutual attunement , nonverbal communication , emotional parental response ) , self-reported parenting stress , and self-reported parent-child relationship in families at risk and families with emotionally neglected children , ages @-@ years .


This was a randomized controlled trial study conducted at a family care center in Denmark .


Eighteen parent-child dyads were randomly assigned to receive @ weekly music therapy sessions with a credentialed music therapist ( n = @ ) or treatment as usual ( n = @ ) .


Observational measures for parent-child interaction , self-reported measures for parenting stress and parent-child relationship were completed at baseline and @ months post-baseline assessment .


Results of the study showed that dyads who received music therapy intervention significantly improved their nonverbal communication and mutual attunement .


Similarly , parents who participated in dyadic music therapy reported themselves to be significantly less stressed by the mood of the child and to significantly improve their parent-child relationship in terms of being better at talking to and understanding their children than parents who did not receive music therapy .


Both groups significantly improved in terms of increased positive and decreased negative emotional parental response , parenting stress and stress in general .


There were no significant between group differences in self-perceived autonomy , attachment , and parental competence .


The dyadic music therapy intervention examined in this study improved emotional communication between parent and child and interaction after @ to @ sessions and can be considered as a viable treatment alternative or supplement for families at risk and families with emotionally neglected children .


Symptoms and symptom burden have a central place in diagnosis and management of atrial fibrillation ( AF ) .


The aim of the present study is to investigate whether severity of AF symptoms impacts prognosis in permanent AF .


We studied the relation between AF symptom severity -LSB- quantified with the Toronto AF Severity Scale ( AFSS ) -RSB- and cardiovascular outcome in patients included in the RACE II study .


The primary endpoint was a composite of cardiovascular morbidity and mortality .


Secondary outcome was cardiovascular hospitalizations .


Of @ permanent AF patients in RACE II , AFSS questionnaires were available in @ patients ( @ % ) .


Mean age was @ @ years .


One hundred and seventy-four patients ( @ % ) reported a low score ( score @-@ ; lowest tertile ) , @ patients ( @ % ) reported a moderate score ( score @-@ ; middle tertile ) , and @ ( @ % ) reported a high score ( score @-@ ; highest tertile ) .


Patients with the most severe symptoms were more often women , had higher N-terminal prohormone of brain natriuretic peptide concentrations , and had more previous heart failure hospitalizations .


Median follow-up was @ ( interquartile range @-@ @ ) years .


The primary endpoint occurred most frequently in the highest tertile of the AFSS -LSB- @ ( @ % ) , @ ( @ % ) , @ ( @ % ) , respectively , P = @ -RSB- , being mainly driven by heart failure hospitalizations -LSB- @ ( @ % ) , @ ( @ % ) , @ ( @ % ) , respectively , P < @ -RSB- .


After multivariable adjustment , higher AFSS scores were associated with the primary endpoint -LSB- hazard ratio @ ( @-@ @ ) , P = @ -RSB- , as well as with cardiovascular hospitalizations -LSB- hazard ratio @ ( @-@ @ ) , P < @ -RSB- .


In permanent AF , after multivariable adjustment , symptom severity is associated with cardiovascular outcome .


Combinations of inhaled long-acting bronchodilator therapies such as muscarinic antagonists and @-agonists may be more effective than monotherapy in the treatment of chronic obstructive pulmonary disease ( COPD ) .


This study was a @-week , Phase III , multicenter , randomized , blinded , double-dummy , parallel-group study of the once-daily , inhaled , fixed-dose combination of the long-acting muscarinic antagonist umeclidinium bromide and the long-acting @-agonist vilanterol ( UMEC/VI @ / @ mcg ) versus tiotropium ( TIO , @ mcg ) .


The primary endpoint was trough forced expiratory volume in @ s ( FEV@ ) at Day @ .


The secondary endpoint was weighted mean FEV@ over @ h post-dose at Day @ .


For key endpoints , a step-down closed testing hierarchy was applied to account for multiplicity .


Other efficacy and safety endpoints were assessed .


Statistically significant improvements in trough FEV@ at Day @ ( @ L , @ % confidence interval -LSB- CI -RSB- : @ , @ ; p < @ ) and weighted mean FEV@ over @ h post-dose at Day @ ( @ L , @ % CI : @ , @ ; p < @ ) were observed for UMEC/VI versus TIO .


In addition UMEC/VI improved health-related quality of life , and reduced requirement for the use of rescue medication compared with TIO .


The incidence of adverse events was similar between treatment groups .


UMEC/VI was associated with statistically significant and clinically meaningful improvements in lung function versus TIO .


UMEC/VI was well tolerated .


UMEC/VI @ / @ mcg could provide an effective new treatment option for patients with moderate-to-very severe COPD .


Previous human studies reported inconsistent effects of dietary protein and branched-chain amino acids ( BCAAs ) on insulin action and glucose metabolism .


Similarly , it is unclear whether saturated fat ( SF ) intake influences these metabolic variables .


The objective of this study was to test the effects of high -LSB- @ % of energy ( % E ) -RSB- vs. moderate ( @ % E ) intakes of protein ( primarily whey ) on insulin action and lipid and lipoprotein concentrations in the context of both high ( @ % E ) and low ( @ % E ) SF diets .


The study was conducted as a randomized controlled trial in @ overweight and obese men and women .


After a @-wk baseline diet -LSB- @ % E carbohydrate , @ % E protein , @ % E fat ( @ % E SF ) -RSB- , participants were randomly assigned to @ wk of either the baseline diet or @ of @ test diets containing @ % E carbohydrate and either @ % E or @ % E protein and either @ % E or @ % E SF .


Frequently sampled i.v. glucose tolerance tests were administered after each dietary period .


Other than significantly higher fasting glucose concentrations for high vs. moderate protein intakes with a low-fat diet ( difference SE : @ @ mmol/L ; P = @ ) , there were no significant effects of dietary protein or SF on glucose metabolism , plasma insulin , or concentrations of lipids and lipoproteins .


Changes in plasma BCAAs across all diets were negatively correlated with changes in the metabolic clearance rate of insulin ( = -@ , P = @ ) and positively correlated with changes in the acute insulin response to glucose ( = @ , P = @ ) .


These findings suggest that short-term intake of BCAAs can influence insulin dynamics .


However , in this group of overweight and obese individuals , neither high protein nor SF intake affected insulin sensitivity or plasma concentrations of lipids and lipoproteins .


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


Combination long-acting bronchodilator therapy may be more effective than long-acting bronchodilator monotherapy in chronic obstructive pulmonary disease ( COPD ) .


To compare the efficacy and safety of once-daily umeclidinium/vilanterol ( UMEC/VI ) @/@ mcg with placebo and UMEC or VI monotherapy in COPD .


This was a double-blind , placebo-controlled , parallel-group study .


A total of @ patients were randomized ( @:@:@:@ ) to @ weeks of treatment with UMEC/VI @/@ mcg , UMEC @ mcg , VI @ mcg , or placebo once-daily via dry powder inhaler .


Primary efficacy endpoint was trough forced expiratory volume in one second ( FEV@ ) on Day @ ( @-@ h post-dose ) .


Additional lung-function , symptomatic and health-related quality of life endpoints were also assessed .


Safety evaluations included : adverse events , vital signs , electrocardiography and clinical laboratory measurements .


All active treatments significantly improved trough FEV@ vs placebo ( @-@ @ L , all p < @ ) .


Improvements with UMEC/VI @/@ mcg were significantly greater than for UMEC @ mcg or VI @ mcg ( @ L and @ L ; both p@ @ ) .


Improvements for UMEC/VI @/@ mcg vs placebo were observed for the transition dyspnea index ( @ unit ; p < @ ) , rescue albuterol use at Weeks @-@ ( -@ puffs/day ) and St. George 's Respiratory Questionnaire ( -@ units , p < @ ) .


No safety signals were observed .


Once-daily UMEC/VI @/@ mcg was well tolerated and provided greater improvements in lung function , health status , and dyspnea scores compared with monotherapy components and placebo over @ weeks .


This study supports the use of UMEC/VI @/@ mcg for the maintenance treatment of COPD .


The set-back suture , an absorbable dermal suturing technique , purportedly improves wound eversion and cosmetic outcomes .


We sought to conduct a split-wound , prospective , randomized study to compare the cosmetic outcome and wound eversion achieved with the set-back suture and the buried vertical mattress suture ( BVMS ) .


A total of @ surgical elliptical wounds were randomized to subcuticular closure with the set-back suture on half and the BVMS on the other .


Maximum eversion height and width were measured immediately postoperatively .


At @ months , @ blinded observers evaluated each scar using a @-point Likert physician global scar assessment scale .


Subjects and observers also completed the validated Patient and Observer Scar Assessment Scale , where a score of @ represents normal-appearing skin and @ represents worst imaginable scar .


In all , @ subjects completed the study .


The set-back suture provided statistically significant wound eversion .


On the Likert scale , observers rated the set-back suture side @ point better than the BVMSside .


Both patient and observer total Patient and Observer Scar Assessment Scale scores were significantly lower for the set-back suture side ( subject mean @ @ vs @ @ -LSB- P = @ -RSB- ; observer mean @ @ vs @ @ -LSB- P = @ -RSB- , respectively ) .


Single institution experience and relatively short follow-up are limitations .


The set-back suture provides superior wound eversion and better cosmetic outcomes than the BVMS .


Macitentan is a novel dual endothelin ( ET ) -@ receptor antagonist to be used in patients with pulmonary arterial hypertension .


This study aimed to assess the pharmacokinetics ( PK ) and pharmacodynamics ( PD ) of macitentan after administration of multiple doses to healthy Korean male subjects .


A randomized , double-blind , placebo-controlled , multiple-ascending dose study was performed in @ healthy male subjects receiving oral macitentan ( @ , @ , or @ mg ) or placebo once daily for @ days .


Plasma concentrations of macitentan , its active metabolite ACT-@ , and ET-@ were evaluated .


Safety and tolerability measurements were conducted throughout the study .


The concentration-time profile of macitentan was characterized by slow absorption ( median time to maximum plasma concentration -LSB- t ( max ) -RSB- @-@ h ) and slow elimination ( mean elimination half-life -LSB- t -RSB- @-@ h ) .


After repeated doses of @ , @ , and @ mg of macitentan over the course of @ days , the peak concentration ( C ( max ) ) increased as the dose increased and the area under the plasma concentration-time curve during the dosing interval ( AUC ( ) ) increased in a dose-proportional manner .


Plasma concentrations showed approximately @ - to @-fold accumulation on day @ compared with day @ .


ACT-@ showed higher levels of exposure than macitentan , its mean half-life was @-@ h , and it accumulated @ - to @-fold .


Macitentan increased plasma ET-@ concentrations at all doses tested and was well tolerated and elicited no serious adverse events .


Multiple oral doses of @ , @ , and @ mg of macitentan were well tolerated in healthy Korean subjects , and its pharmacokinetics correlated positively with ET-@ concentrations .


This study investigated the safety and immunogenicity of different formulations and schedules of a candidate subunit herpes zoster vaccine containing varicella-zoster virus glycoprotein E ( gE ) with or without the adjuvant system AS@B .


In this phase II , single-blind , randomized , controlled study , adults aged @years ( N = @ ) received one dose of @ggE/AS@B , two doses , two months apart , of @ , @ , or @ggE/AS@B , or two doses of unadjuvanted @ggE/saline .


Frequencies of CD@ ( + ) T cells expressing @ activation markers following induction with gE were measured by intracellular cytokine staining and serum anti-gE antibody concentrations by ELISA .


Frequencies of gE-specific CD@ ( + ) T cells were > @-fold higher after two doses of all gE/AS@B formulations than after one dose of @ggE/AS@B or two doses of @ggE/saline .


Frequencies were comparable after two doses of @ , @ , or @ggE/AS@B .


Serum anti-gE antibody concentrations were comparable after two doses of @ or @ggE/AS@B and higher than in the other groups .


Immune responses persisted for at least @ months .


Reactogenicities of all gE/AS@B formulations were similar but greater than with gE/saline .


The three formulations of gE/AS@B were immunogenic and well tolerated in adults aged @years .


Two vaccinations with gE/AS@B induced higher immune responses than one and the dose of gE impacted humoral but not cellular immune responses ( NCT@ ) .


In Denmark , guidelines on low back pain management are currently being implemented ; in association with this , a clinical trial is conducted .


A health economic evaluation is carried out alongside the clinical trial to assess the cost-effectiveness of an extended implementation strategy to increase the general practitioners ' adherence to the guidelines .


In addition to usual dissemination , the extended implementation strategy is composed of visits from a guideline facilitator , stratification tools , and feedback on guideline adherence .


The aim of this paper is to provide the considerations on the design of the health economic evaluation .


The economic evaluation is carried out alongside a cluster randomised controlled trial consisting of @ general practices in the North Denmark Region .


An expected @,@ patients between the age of @ and @ years with a low back pain diagnosis will be enrolled .


The economic evaluation comprises both a cost-effectiveness analyses and a cost-utility analysis .


Effectiveness measures include referral to secondary care , health-related quality of life measured by EQ-@D-@L , and disability measured by the Roland Morris disability questionnaire .


Cost measures include all relevant additional costs of the extended implementation strategy compared to usual implementation .


The economic evaluation will be performed from both a societal perspective and a health sector perspective with a @-month time horizon .


It is expected that the extended implementation strategy will reduce the number of patients referred to secondary care .


It is hypothesised that the additional upfront cost of extended implementation will be counterbalanced by improvements in clinical practice and patient-related outcomes , thereby rendering the extended implementation strategy cost-effective .


Many pathogenic processes and diseases are the result of an erroneous activation of the complement cascade and a number of inhibitors of complement have thus been examined for anti-inflammatory actions .


It was recently demonstrated that supraphysiological concentrations of the endogenous complement inhibitor MAp@ ( also denoted MAP@ ) protect against myocardial reperfusion injury .


In the present study , we examined the association between outcome after acute myocardial infarction ( MI ) and the plasma levels of MAp@ and its related proteins MASP-@ and MASP-@ in patients with first-time MI .


In addition , we compared plasma levels of MAp@ , MASP-@ , and MASP-@ in MI patients to levels in a healthy control group .


A total of @ MI patients and @ control persons were included .


Plasma samples were obtained and analysed with time-resolved immunofluorometric assays determining the plasma levels of MAp@ , MASP-@ , and MASP-@ .


The myocardial outcomes ( salvage index and final infarct size ) were measured by gated single-photon emission CT. .


MI patients had @ % higher plasma levels of MAp@ ( IQR @-@ % ) as compared to the healthy control group ( p < @ .


However , neither salvage index ( Spearman rho -@ , p = @ ) nor final infarct size ( Spearman rho @ , p = @ ) correlated with plasma levels of MAp@ .


Likewise , MASP-@ and MASP-@ were elevated in MI patients ( p = @ and p < @ ) , but the levels were not correlated to outcome .


Plasma levels of MAp@ , MASP-@ , and MASP-@ are significantly higher in patients with MI compared to healthy control persons , but are not associated with short-term outcome measured as salvage index and final infarct .


The optimum duration of androgen deprivation combined with high-dose radiotherapy in prostate cancer remains undefined .


We aimed to determine whether long-term androgen deprivation was superior to short-term androgen deprivation when combined with high-dose radiotherapy .


In this open-label , multicentre , phase @ randomised controlled trial , patients were recruited from ten university hospitals throughout Spain .


Eligible patients had clinical stage T@c-T@b N@M@ prostate adenocarcinoma with intermediate-risk and high-risk factors according to @ National Comprehensive Cancer Network criteria .


Patients were randomly assigned ( @:@ ) using a computer-generated randomisation schedule to receive either @ months of androgen deprivation combined with three-dimensional conformal radiotherapy at a minimum dose of @ Gy ( range @-@ Gy ; short-term androgen deprivation group ) or the same treatment followed by @ months of adjuvant androgen deprivation ( long-term androgen deprivation group ) , stratified by prostate cancer risk group ( intermediate risk vs high risk ) and participating centre .


Patients assigned to the short-term androgen deprivation group received @ months of neoadjuvant and concomitant androgen deprivation with subcutaneous goserelin ( @ months before and @ months combined with high-dose radiotherapy ) .


Anti-androgen therapy ( flutamide @ mg per day or bicalutamide @ mg per day ) was added during the first @ months of treatment .


Patients assigned to long-term suppression continued with the same luteinising hormone-releasing hormone analogue every @ months for another @ months .


The primary endpoint was biochemical disease-free survival .


Analysis was by intention to treat .


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


Between Nov @ , @ , and Dec @ , @ , @ patients were randomly assigned to receive short-term androgen deprivation and @ to receive long-term androgen deprivation .


After a median follow-up of @ months ( IQR @-@ ) , @-year biochemical disease-free survival was significantly better among patients receiving long-term androgen deprivation than among those receiving short-term treatment ( @ % -LSB- @ % CI @-@ -RSB- vs @ % -LSB- @-@ -RSB- ; hazard ratio -LSB- HR -RSB- @ -LSB- @ % CI @-@ -RSB- ; p = @ ) .


@-year overall survival ( @ % -LSB- @ % CI @-@ -RSB- vs @ % -LSB- @-@ -RSB- ; HR @ -LSB- @ % CI @-@ -RSB- ; p = @ ) and @-year metastasis-free survival ( @ % -LSB- @ % CI @-@ -RSB- vs @ % -LSB- @-@ -RSB- ; HR @ -LSB- @ % CI @-@ -RSB- ; p = @ ) were also significantly better in the long-term androgen deprivation group than in the short-term androgen deprivation group .


The effect of long-term androgen deprivation on biochemical disease-free survival , metastasis-free survival , and overall survival was more evident in patients with high-risk disease than in those with low-risk disease .


Grade @ late rectal toxicity was noted in three ( @ % ) of @ patients in the long-term androgen deprivation group and two ( @ % ) of @ in the short-term androgen deprivation group ; grade @-@ late urinary toxicity was noted in five ( @ % ) patients in each group .


No deaths related to treatment were reported .


Compared with short-term androgen deprivation , @ years of adjuvant androgen deprivation combined with high-dose radiotherapy improved biochemical control and overall survival in patients with prostate cancer , particularly those with high-risk disease , with no increase in late radiation toxicity .


Longer follow-up is needed to determine whether men with intermediate-risk disease benefit from more than @ months of androgen deprivation .


The main objective of this pilot study was to explore the effect of chiropractic high-velocity , low-amplitude ( HVLA ) manipulation on vertical jump height in young female athletes with talocrural joint dysfunction .


This was a randomized assessor-blind clinical pilot trial .


Twenty-two female handball players with talocrural joint dysfunction were randomized to receive either HVLA manipulation ( n = @ ) or sham treatment ( n = @ ) once a week during a @-week period .


The main outcome was change in vertical jump height from baseline to follow-up within and between groups after @ weeks .


Nineteen athletes completed the study .


After @ weeks , the group receiving HVLA manipulation ( n = @ ) had a statistically significant mean ( SD ) improvement in vertical jump height of @ ( @ ) cm ( P = @ ) .


The sham treatment group ( n = @ ) improved their vertical jump height by @ ( @ ) cm ( P = @ ) .


The between groups ' change was @ cm ( @ % confidence interval , -@ to @ ; P = @ ) in favor of the group receiving HVLA manipulation .


Blinding and sham procedures were feasible , and there were no reported adverse events .


The results of this pilot study show that a larger-scale study is feasible .


Preliminary results suggest that chiropractic HVLA manipulation may increase vertical jump height in young female athletes with talocrural joint dysfunction .


However , the clinical result in favor of HVLA manipulation compared with sham treatment needs statistical confirmation in a larger randomized clinical trial .


To investigate whether a novel ultrasound device may be used with a simplified augmented reality technique , and to compare this device with conventional techniques during vascular access using a vascular phantom .


Prospective , randomized study .


Anesthesiology and Pain Medicine departments of a university-affiliated hospital .


@ physicians with no experience with ultrasound-guided techniques .


All participants performed the vascular access technique on the vascular phantom model using both a conventional device and the new ultrasound device .


Time and the number of redirections of the needle until aspiration of dye into a vessel of the vascular phantom were measured .


The median/interquartile range of time was @ / @ seconds versus @ / @ seconds ( P < @ ) and number of redirections was @/@ @ versus @/@ ( P < @ ) for the conventional and novel ultrasound devices , respectively .


During vascular access in a vascular phantom model , the novel device decreased the time and the number of redirections significantly .


The device successfully improved the efficiency of the ultrasound-guided vascular access technique .


The mechanisms behind heterologous immunity and non-specific effects of vaccines on mortality are not well understood .


We examined associations between cytokine responses and subsequent mortality in low-birth-weight infants in Guinea-Bissau .


A low-birth-weight trial randomized children to Bacille Calmette-Gurin ( BCG ) at birth or later according to local policy .


Blood samples were obtained from a sub-group at age @ weeks .


Interleukin ( IL ) -@ , IL-@ , IL-@ , interferon ( IFN ) - , and tumor necrosis factor ( TNF ) - were measured in whole-blood cell cultures stimulated with lipopolysaccharide ( LPS ) , phytohaemagglutinin ( PHA ) , or purified protein derivative ( PPD ) .


The outcome was mortality between bleeding and @ year of age .


Non-linear associations between cytokine responses and mortality were examined .


Cytokine measurements were available from @ children .


The mortality rate ( MR ) was high ( @ / @ person-years-observation ( PYO ) ) .


Both low and high cytokine responses to LPS and PHA were associated with high mortality ( MR up to @/@ PYO in the lowest @ % and @ / @ PYO in the highest @ % ) .


In BCG-vaccinated children , higher IFN - responses to PPD were associated with better survival ( MR ratio = @ ( @-@ @ ) ) .


Data presented a rare opportunity to explore associations between cytokine responses and mortality .


Both low and high cytokine responses were associated with high mortality ; a balanced response to invading pathogens seems preferable .


Hospitalization is an important outcome in pulmonary arterial hypertension ( PAH ) , shown previously to correlate with survival .


Using the Registry to Evaluate Early and Long-term PAH Disease Management ( REVEAL Registry ) , we sought to characterize first-time hospitalizations and their effect on subsequent hospitalization and survival in patients with newly diagnosed disease .


Patients with newly diagnosed PAH ( n = @ , World Health Organization group @ ) were evaluated for first-time hospitalization .


The hospitalizations were categorized as PAH related or PAH unrelated based on the case report form .


Categories for PAH-related and PAH-unrelated hospitalization were defined before independent review .


Patient demographics and disease characteristics are described as well as freedom from hospitalization and survival .


Of @ patients , @ ( @ % ) had one or more hospitalizations postenrollment : @ ( @ % ) PAH related , @ ( @ % ) PAH unrelated , and @ ( @ % ) of undetermined causes .


The most common causes of PAH-related hospitalization were congestive heart failure and placement/removal of a central venous catheter .


Patients with PAH-related hospitalizations were more likely to receive parenteral therapy , be in functional class III/IV , and have higher risk scores before hospitalization at enrollment .


Following discharge , @ % @ % and @ % @ % of patients with PAH-related and PAH-unrelated first hospitalization , respectively , remained hospitalization-free for @ years ( P = @ ) .


Survival estimates at @ years postdischarge were @ % @ % and @ % @ % ( P = @ ) for patients with PAH-related and PAH-unrelated hospitalization , respectively .


In the REVEAL Registry , PAH-related hospitalization was associated with relatively more rehospitalizations and worse survival at @ years .


Patients treated with oral anticoagulants have increased susceptibility to bleeding , and therefore any surgical medical procedure and especially oral surgery requires a therapeutic approach that minimizes bleeding effects in these patients .


The working hypothesis was based on studies of local application of tranexamic acid after maxillofacial interventions as effective therapeutic alternative for the prevention and control of bleeding .


The aim was to assess the effectiveness of the application of a gel solution tranexamic acid after tooth extraction in anticoagulated patients in terms of healing time and degree of healing .


The results indicate that application of tranexamic acid gel is very effective for consistency and maintenance in the place of action and shows its efficacy as a procoagulant material .


The application of a gel solution of tranexamic acid in oral anticoagulants patients ameliorates healing time and the bleeding time within the first @-@ h.


The impact of food on relapse in ulcerative colitis has not been clearly defined .


The aim of this prospective , randomized-controlled study was to evaluate the impact of comprehensive dietary guidelines on the clinical course of the disease and quality of life in patients with ulcerative colitis .


Patients were allocated randomly to an intervention or a control group .


Participants in the intervention group were provided dietary guidelines in the form of an educational booklet that was recommended for use for @-@ weeks during disease flare , that patients eat little and often ( four to six times a day ) , drink adequate fluids , decrease excess intake of fat , decrease simple carbohydrates and decrease high-fibre foods during flare.Validated and study-designed questionnaires were used to compare patients ' perceived quality of life , colitis activity scores and eating habits before and following the dietary advice provided .


Overall , @ patients completed the study .


Study participants were asked to complete the Inflammatory Bowel Disease Questionnaire and Simple Clinical Colitis Activity Index together with the Food Frequency Questionnaire at @ , @ and @ weeks .


At @ weeks , there was a mean reduction in the Simple Clinical Colitis Activity Index score in the intervention group compared with an increase in the score in the control group -LSB- -@ ( P = @ ) vs. @ ( P = @ ) -RSB- .


There was a mean increase in the Inflammatory Bowel Disease Questionnaire score in the intervention group compared with a reduction in the score in the control group -LSB- @ ( P = @ ) vs. -@ ( P = @ ) -RSB- .


A total of @ % of patients in the intervention group found the dietary advice significantly or moderately helpful .


The study suggests that there is likely to be a link between the dietary advice provided and symptomatic improvement .


The effect of diet may not occur through the addition or the elimination of single nutrients ; rather , each food consumed combines many nutrients that allow for a synergistic or an antagonistic action when present in a certain composition .


Intravitreal injection ( IVT ) is one of the most common vitreoretinal procedures , a large majority are performed with local anesthesia .


The purpose of this study was to investigate the safety to the cornea and anesthetic efficacy of five concentrations of lidocaine gel .


A prospective clinical trial was conducted testing lidocaine gel in five preparations : @ , @ , @ , @ and @ % .


Patients with macular degeneration , diabetic edema or retina vein occlusion were scheduled for intravitreal treatment received topical anesthesia with lidocaine gel @ and @ min before the procedure .


Patients answered the visual analog scale for pain during the procedure .


Corneal and conjunctival was evaluated using the Oxford scale .


In total , @ patients were randomized into five groups .


The mean pain scores ( standard deviation ) were @ ( @ ) in the @ % group , @ ( @ ) in the @ % ; @ ( @ ) in the @ % , @ ( @ ) in the @ % and @ ( @ ) in the @ % group .


Mean pain score among all groups was similar ( p = @ ) .


There was no significant difference between groups in regard to keratitis mean score ( p = @ ) .


Lidocaine gel at concentrations from @ to @ % induced similar anesthetic effect for IVTs , without adverse effects on cornea and conjunctiva .


To evaluate the efficacy and safety of intravitreal bevacizumab ( Avastin ; Genentech , South San Francisco , CA ) in patients with neovascular age-related macular degeneration ( nAMD ) using @ different treatment regimens in which patients were assessed clinically at up to @-week intervals .


Randomized , controlled , noninferiority trial .


A total of @ patients with nAMD .


Patients were treated with @ mg intravitreal bevacizumab and followed up to @ weeks .


They were randomized into @ arms .


All patients received @ loading doses @ weeks apart and thereafter were assessed every @ weeks until the end of the study .


One arm received a routine treatment at each @-week assessment , and the other arm was treated at these assessments on an as-needed basis .


After the loading doses , patients in either arm who showed signs of disease activity had an additional assessment after @ weeks and at that visit had top-up treatments on an as-needed basis .


Mean best-corrected visual acuity ( BCVA ) at @ weeks .


At @ weeks , patients who had treatments every @ weeks had superior BCVA to those treated on an as-needed basis every @ weeks ( P = @ ) , with the regular treatment arm gaining a mean BCVA of @ letters and the as-needed treatment arm gaining @ letters .


The regular treatment arm of the study showed significantly improved outcomes with respect to @ - , @ - , and @-letter changes in BCVA from baseline compared with the as-needed treatment arm , as well as superior reading speed .


In patients who completed the study , up to but not including week @ , the mean number of treatments was @ for the regular treatment arm and @ for the as-needed treatment arm .


A treatment regimen with regular bevacizumab injections every @ weeks after loading doses supplemented with as-needed top-up treatments produced a stable improvement in BCVA from baseline .


The improvement in BCVA was broadly similar to that obtained in other studies using anti-vascular endothelial growth factor drugs with more frequent assessments and treatments .


To report our prospective comparison of clinical efficacy between multimodular flexible ureteroscope , PolyScope , and conventional flexible ureteroscope , both combined with holmium laser lithotripsy in managing renal stones < @cm in diameter .


Between February @ and July @ , a total of @ adult patients with renal stones were randomized in a single tertiary-care center trial .


For @ patients in each arm , flexible ureteroscopy and holmium laser lithotripsy were done with either PolyScope or Olympus URF P-@ as control .


The primary end points were single-session stone fragmentation rate and stone-free rate .


The secondary end points comprised operation time , complication rate , and hospital stay .


Demographic and preoperative parameters were comparable between @ groups .


For stones of different locations and sizes , single-session stone fragmentation rate of PolyScope was similar to that of URF P-@ .


However , for lower calyceal stones , URF P-@ was significantly better than PolyScope ( @ % vs @ % ; P = @ ) .


No statistically significant difference existed in single-session or overall stone-free rate , complication rate , and hospital stay .


Mean operation time of PolyScope group was @ minutes , @minutes ( @ % ) longer than that of URF P-@ group @ minutes ( P < @ ) .


PolyScope demonstrates similar overall stone clearance rate to a conventional flexible ureteroscope in managing renal calculi < @cm in diameter , but for lower pole stones , it is of inferior efficacy and it is more skillfully demanding , taking longer operation time .


The purposes of this study were to use functional magnetic resonance imaging to investigate the immediate changes in functional connectivity ( FC ) between brain regions that process and modulate the pain experience after @ different types of manual therapies ( MT ) and to identify reductions in experimentally induced myalgia and changes in local and remote pressure pain sensitivity .


Twenty-four participants ( @ men ; mean age SD , @ @ years ) who completed an exercise-injury protocol to induce low back pain were randomized into @ groups : chiropractic spinal manipulation ( n = @ ) , spinal mobilization ( n = @ ) , or therapeutic touch ( n = @ ) .


The primary outcome was the immediate change in FC as measured on functional magnetic resonance imaging between the following brain regions : somatosensory cortex , secondary somatosensory cortex , thalamus , anterior and posterior cingulate cortices , anterior and poster insula , and periaqueductal gray .


Secondary outcomes were immediate changes in pain intensity , measured with a @-point numeric rating scale , and pain sensitivity , measured with a handheld dynamometer .


Repeated-measures analysis of variance models and correlation analyses were conducted to examine treatment effects and the relationship between within-person changes across outcome measures .


Changes in FC were found between several brain regions that were common to all @ MT interventions .


Treatment-dependent changes in FC were also observed between several brain regions .


Improvement was seen in pain intensity after all interventions ( P < @ ) with no difference between groups ( P > @ ) .


There were no observed changes in pain sensitivity , or an association between primary and secondary outcome measures .


These results suggest that MTs ( chiropractic spinal manipulation , spinal mobilization , and therapeutic touch ) have an immediate effect on the FC between brain regions involved in processing and modulating the pain experience .


This suggests that neurophysiologic changes after MT may be an underlying mechanism of pain relief .


This study tested the hypothesis that pioglitazone reduces endothelin-@ activity in the forearm vasculature in non-diabetic patients with hypertension or hypercholesterolemia and variable degrees of insulin resistance .


We conducted a single center , randomized , double-blind , placebo controlled , cross-over trial in @ patients with either hypertension or hypercholesterolemia and further classified as insulin-sensitive or insulin-resistant based on a published insulin sensitivity index .


Participants received pioglitazone @ mg daily or matching placebo for eight weeks .


The main endpoint was the change in forearm vascular endothelin-@ activity , as assessed by intra-arterial infusion of the endothelin type A receptor blocker BQ-@ , measured at the end of each @-week treatment period .


Pioglitazone lowered plasma insulin ( P < @ ) , improved insulin sensitivity ( P < @ ) , increased HDL ( P < @ ) , and reduced triglycerides ( P = @ ) , free fatty acids ( P = @ ) , and C-reactive protein ( P = @ ) .


However , pioglitazone did not affect the vasodilator response to BQ-@ in the whole group ( P = @ ) and in the diagnosis or insulin sensitivity subgroups .


Hence , in non-diabetic patients with hypertension or hypercholesterolemia , PPAR activation with pioglitazone does not affect endothelin-@ activity , despite enhancing insulin sensitivity and reducing plasma insulin and C-reactive protein levels .


In non-diabetic patients with hypertension or hypercholesterolemia , pioglitazone improves insulin sensitivity , lipid profile , and inflammation but does not affect endothelin activity .


Our data suggest that the determinants of endothelin-@ vascular activity in vivo may differ and/or be more complex than those suggested by the results of previous in vitro studies .


There is a need for interventions to promote uptake of breast screening throughout Europe .


We performed a single-blind randomised controlled trial to test whether text-message reminders were effective .


Two thousand two hundred and forty women receiving their first breast screening invitation were included in the study and randomly assigned in a @:@ ratio to receive either a normal invitation only ( n = @ ) or a normal invitation plus a text-message reminder @h before their appointment ( n = @ ) .


In the intention-to-treat analysis , uptake of breast screening was @ % among women in the normal invitation group and @ % in the text-message reminder group ( ( @ ) = @ , odds ratio ( OR ) : @ , @ % confidence intervals ( CI ) : @-@ @ , P = @ ) .


Of the @ women assigned to the text-message reminder group , only @ ( @ % ) had a mobile number recorded by their GP and were thereby sent a text .


In the per-protocol analysis , uptake by those in the control group who had a mobile number recorded on the GP system was @ % and by those in the intervention group who were sent a reminder @ % ( ( @ ) = @ , OR = @ , @ % CI = @-@ @ , P < @ ) .


Sending women a text-message reminder before their first routine breast screening appointment significantly increased attendance .


This information can be used to allocate resources efficiently to improve uptake without exacerbating social inequalities .


Although exercise has been addressed as an adjuvant treatment for anxiety , depression and cancer-related symptoms , limited studies have evaluated the effectiveness of exercise in patients with lung cancer .


We recruited @ patients from a medical centre in northern Taiwan , and randomly assigned them to either a walking-exercise group ( n = @ ) or a usual-care group ( n = @ ) .


We conducted a @-week exercise programme that comprised home-based , moderate-intensity walking for @min per day , @ days per week , and weekly exercise counselling .


The outcome measures included the Hospital Anxiety and Depression Scale and the Taiwanese version of the MD Anderson Symptom Inventory .


We analysed the effects of the exercise programme on anxiety , depression and cancer-related symptoms by using a generalised estimating equation method .


The exercise group patients exhibited significant improvements in their anxiety levels over time ( P = @ and @ in the third and sixth months , respectively ) and depression ( P = @ and @ in the third and sixth months , respectively ) than did the usual-care group patients .


The home-based walking exercise programme is a feasible and effective intervention method for managing anxiety and depression in lung cancer survivors and can be considered as an essential component of lung cancer rehabilitation .


To determine whether re-feeding of gastric residual volumes reduces the time needed to achieve full enteral feeding in preterm infants .


Parallel-group randomised controlled trial with a @:@ allocation ratio .


Regional referral neonatal intensive care unit .


@ infants of gestational age @ ( @/@ ) to @ ( @/@ ) weeks receiving minimal enteral nutrition ( < @ mL/kg/day ) during the first week after birth .


Infants were randomised to either be re-fed with gastric residual volumes ( Re-feeding group ) or receive fresh formula/human milk ( Fresh-feeding group ) whenever large gastric residual volumes were noted .


The primary efficacy end point was time to achieve full enteral feeding ( @ mL/kg/day ) after randomisation .


The mean time to full enteral feeding was @ days in the Re-feeding group and @ days in the Fresh-feeding group ( mean difference favouring re-feeding : -@ days ; @ % CI -@ to @ ; p = @ ) .


The composite safety end point of spontaneous intestinal perforation , surgical necrotising enterocolitis , or death occurred in @ of @ infants ( @ % ) in the Re-feeding group versus @ of @ infants ( @ % ) in the Fresh-feeding group ( p = @ ) .


Re-feeding gastric residual volumes in extremely preterm infants does not reduce time to achieve full enteral feeding .


This trial suggests that re-feeding might be as safe as fresh feeding , but further research is needed , due to lack of sufficient statistical power in this study for safety analysis .


Examination of arthroscopic skill requires evaluation tools that are valid and reliable with clear criteria for passing .


The Arthroscopic Surgery Skill Evaluation Tool was developed as a video-based assessment of technical skill with criteria for passing established by a panel of experts .


The purpose of this study was to test the validity and reliability of the Arthroscopic Surgery Skill Evaluation Tool as a pass-fail examination of arthroscopic skill .


Twenty-eight residents and two sports medicine faculty members were recorded performing diagnostic knee arthroscopy on a left and right cadaveric specimen in our arthroscopic skills laboratory .


Procedure videos were evaluated with use of the Arthroscopic Surgery Skill Evaluation Tool by two raters blind to subject identity .


Subjects were considered to pass the Arthroscopic Surgery Skill Evaluation Tool when they attained scores of @ on all eight assessment domains .


The raters agreed on a pass-fail rating for fifty-five of sixty videos rated with an interclass correlation coefficient value of @ .


Ten of thirty participants were assigned passing scores by both raters for both diagnostic arthroscopies performed in the laboratory .


Receiver operating characteristic analysis demonstrated that logging more than eighty arthroscopic cases or performing more than thirty-five arthroscopic knee cases was predictive of attaining a passing Arthroscopic Surgery Skill Evaluation Tool score on both procedures performed in the laboratory .


The Arthroscopic Surgery Skill Evaluation Tool is valid and reliable as a pass-fail examination of diagnostic arthroscopy of the knee in the simulation laboratory .


This study demonstrates that the Arthroscopic Surgery Skill Evaluation Tool may be a useful tool for pass-fail examination of diagnostic arthroscopy of the knee in the simulation laboratory .


Further study is necessary to determine whether the Arthroscopic Surgery Skill Evaluation Tool can be used for the assessment of multiple arthroscopic procedures and whether it can be used to evaluate arthroscopic procedures performed in the operating room .


To determine effect of change in urine excretion of isoflavonoids on cognitive change .


Post hoc analysis of isoflavonoid exposure ( mean @ years ) during the randomized , placebo-controlled , double-blind Women 's Isoflavone Soy Health trial .


General community .


Healthy postmenopausal women ( N = @ ) .


Twenty-five grams of isoflavone-rich soy protein ( @ mg of aglycone weight isoflavones : @ mg genistein , @ mg daidzein , @ mg glycitein ) or milk protein-matched placebo provided daily .


Overnight urine excretion , fasting plasma levels of isoflavonoids , and cognitive function measured at baseline and endpoint .


Three hundred women ( age : mean @ , range @-@ ) completed both cognitive assessments and did not use hormone replacement therapy during the trial .


Mean on-trial change from baseline in urine excretion of isoflavonoids was not significantly associated with change in a composite score of global cognition ( P = @ ) .


Secondary analyses indicated that change in urine excretion of isoflavonoids was inversely associated with change in a factor score representing general intelligence ( P = @ ) but not with factor scores representing verbal or visual episodic memory .


Mean differences in this general intelligence factor score between women in the lowest and highest quartiles of isoflavonoid change were equivalent to an approximate @-year age-associated decline .


Analyses based on plasma isoflavonoid levels yielded similar but attenuated results .


In healthy postmenopausal women , long-term changes in isoflavonoids are not associated with global cognition , supporting clinical trial results , although greater isoflavonoid exposure from dietary supplements is associated with decrements in general intelligence but not memory ; this finding requires confirmation in future studies .


To investigate the therapeutic value of Gastrografin in shortening duration of prolonged postoperative ileus ( PPOI ) after elective colorectal surgery .


Gut wall edema is central to the pathogenesis of PPOI .


Hyperosmotic , orally administered , water-soluble contrast media such as Gastrografin are theoretically capable of mitigating this edema .


A double-blinded , placebo-controlled , randomized trial was conducted .


Participants were allocated to receive @ mL of Gastrografin ( Exposure Group ) or flavored distilled water ( Control Group ) administered enterally .


Other aspects of management were standardized .


Resolution of PPOI was assessed @-hourly .


Eighty patients were randomized equally , with @ in the Exposure Group and @ in the Control Group excluded from analysis .


Participants were evenly matched at baseline .


Mean duration of PPOI did not differ between Exposure and Control Groups ( @ vs @ hours ; P = @ ) .


When considering individual markers of PPOI resolution , Gastrografin did not affect time to resolution of nausea and vomiting ( @ vs @ hours ; P = @ ) or consumption of oral diet ( @ vs @ hours ; P = @ ) .


However , it accelerated time to flatus or stool ( @ vs @ hours ; P = @ ) and time to resolution of abdominal distension ( @ vs @ hours ; P = @ ) .


There were no significant differences between groups in nasogastric output ; analgesia , antiemetic , or fluid requirement ; complications ; or length of stay .


Gastrografin is not clinically useful in shortening an episode of PPOI characterized by upper and lower gastrointestinal symptoms .


It may however be of therapeutic benefit in the subset of PPOI patients who display lower gastrointestinal symptoms exclusively after surgery .


A randomized clinical trial is needed to evaluate what is the best photodynamic therapy ( PDT ) protocol to use for acute central serous chorioretinopathy .


To compare the efficacy and safety of a @ % dose of verteporfin ( a method of PDT ) with the efficacy and safety of a @ % dose for acute central serous chorioretinopathy .


A multicenter , noninferiority , double-masked , randomized , controlled , clinical trial in which @ patients ( @ eyes ) with acute central serous chorioretinopathy for less than @ months were recruited with a follow-up of @ months from university-based ophthalmology practices .


Patients were randomly assigned to either a @ % dose of verteporfin ( the @ % - dose PDT group ) or a @ % dose ( the @ % - dose PDT group ) .


The @ primary outcome measures were the proportion of eyes with complete absorption of subretinal fluid and the proportion of eyes with complete disappearance of fluorescein leakage at @ and @ months .


The secondary outcome measures included the subretinal fluid recurrent rate , the fluorescein leakage recurrent rate at @ months , the mean best-corrected visual acuity , the retinal thickness of the foveal center , and the maximum retinal thickness at each scheduled visit .


The noninferiority of the @ % - dose PDT compared with the @ % - dose PDT for the primary outcomes was not demonstrated .


The optical coherence tomography-based improvement rate in the @ % - dose PDT group was less than that in the @ % - dose PDT group both at @ months ( @ % vs @ % ; = @ , P = @ ) and at @ months ( @ % vs @ % ; = @ , P = @ ) .


The fluorescein angiography-based improvement rate in the @ % - dose PDT group was less than that in the @ % - dose PDT group both at @ months ( @ % vs @ % ; = @ , P = @ ) and at @ months ( @ % vs @ % ; = @ , P = @ ) .


The subretinal fluid recurrence rate in the @ % - dose PDT group was greater than that in the @ % - dose PDT group ( @ % vs @ % at @ months ; P = @ , determined by use of the log-rank test ) .


The fluorescein leakage recurrent rate in the @ % - dose PDT group was significantly higher than that in the @ % - dose PDT group ( @ % vs @ % at @ months ; P = @ , determined by use of the log-rank test ) .


No ocular adverse event was encountered in the study .


A @ % dose of verteporfin may be more effective at resolving subretinal fluid and fluorescein leakage , and with better visual outcomes , than a @ % dose for acute central serous chorioretinopathy .


Conventional Valsalva maneuver ( CV ) is a standardprocedure to exhibit reverse venous flow atsaphenofemoral junction ( SFJ ) by duplex ultrasonography ( DUS ) .


However some patients could not undergo CV during examination .


Compare blowing party balloon assisted Valsalva ( PBAV ) with CV for exhibiting the reverse venous flow at SFJ incompetence .


Forty patients who had symptoms and signs of suspected saphenofemoral junction incompetence were examined for venous reflux by DUS with two techniques of Valsalva maneuver PBAV and CV The design was a @x@ cross-over study .


The patients were randomized to two sequences .


The first sequence performed CV before PBAV The second sequence performed PBAV before CV The timing for the instruction , reflux time , and total timing of examination were compared between the two sequences .


There was neither period effect nor treatment-period interaction .


Both PBAV and CV could equally identify SFJ reflux , but teaching time and total examination time in PBAV was shorter than CV .


PBAV is a new option to exhibit reverse venous flow at SFJ by DUS .


PBAV is easier and spend less time than CV


Obesity has long been associated with psoriasis and it is considered to be an independent risk factor for chronic heart diseases in these patients .


Recently , some of the biologic drugs used for psoriasis have been reported to cause increase in body weight .


It is currently not clear if this increased body weight seen in psoriasis patients on biologics leads to decrease in there efficacy or vice versa .


We carried out this study to see if reduction in body weight leads to increased efficacy of biologics in obese psoriasis patients .


To evaluate the effect of weight reduction by dietary control on treatment efficacy of biologics in obese patients as indicated by the Psoriasis Area and Severity Index ( PASI ) score .


Obese patients with psoriasis receiving biologic therapy , satisfying the inclusion criterion , were randomized in a @:@ ratio to receive low-calorie diet versus normal diet ( control group ) .


We included @ patients with moderate to severe , stable plaque psoriasis with a PASI score @:@ on anti TNF - biologic therapy ( infliximab , etanercept , ustekinumab and adalimumab ) .


The patients in the dietary intervention group were given a low calorie diet ( @ kcal per day ) for @ weeks to induce weight loss .


The treatment outcome was assessed using PASI .


The PASI scores were assessed at baseline and every @ weeks up to week @ .


There were no significant differences in age , sex distribution , body weight , body mass index , waist circumference , psoriasis duration , or PASI score between the two studied groups at base line .


At week @ , the mean ( SD ) weight loss was @ @ kg in the diet intervention group , and -@ @ kg in the control group .


The average improvement in mean PASI score was @ % for the diet group , and @ % for the control group .


PASI @ was achieved by @ % in the diet group , and @ % in the control group ( p < @ ) .


The mean ( SD ) body surface area values at week @ were @ @ % and @ @ % in the diet group and control group .


Body weight reduction in obese patients on biologics may increase the efficacy of the drug .


Antenatal depression and anxiety are associated with adverse obstetric and mental health outcomes , yet practicable nonpharmacological therapies , particularly for the latter , are lacking .


Yoga incorporates relaxation and breathing techniques with postures that can be customized for pregnant women .


This study tested the efficacy of yoga as an intervention for reducing maternal anxiety during pregnancy .


Fifty-nine primiparous , low-risk pregnant women completed questionnaires assessing state ( State Trait Anxiety Inventory ; STAI-State ) , trait ( STAI-Trait ) , and pregnancy-specific anxiety ( Wijma Delivery Expectancy Questionnaire ; WDEQ ) and depression ( Edinburgh Postnatal Depression Scale ; EPDS ) before randomization ( baseline ) to either an @-week course of antenatal yoga or treatment-as-usual ( TAU ) ; both groups repeated the questionnaires at follow-up .


The yoga group also completed pre - and postsession state anxiety and stress hormone assessments at both the first and last session of the @-week course .


A single session of yoga reduced both subjective and physiological measures of state anxiety ( STAI-S and cortisol ) ; and this class-induced reduction in anxiety remained at the final session of the intervention .


Multiple linear regression analyses identified allocation to yoga as predictive of greater reduction in WDEQ scores ( B = -@ ; BCa @ % CI = -@ to -@ ; P = @ ; d = -@ ) , while allocation to TAU was predictive of significantly increased elevation in EPDS scores ( B = -@ ; BCa @ % CI = -@ to -@ ; P = @ ; d = -@ ) .


No significant differences were observed in state or trait anxiety scores between baseline and follow-up .


Antenatal yoga seems to be useful for reducing women 's anxieties toward childbirth and preventing increases in depressive symptomatology .


Vitamin D has wide-ranging effects on the immune system , and studies suggest that low serum vitamin D levels are associated with worse clinical outcomes in HIV .


Recent studies have identified an interaction between antiretrovirals used to treat HIV and reduced serum vitamin D levels , but these studies have been done in North American and European populations .


Using a prospective cohort study design nested in a multinational clinical trial , we examined the effect of three combination antiretroviral ( cART ) regimens on serum vitamin D levels in @ cART-nave , HIV-infected adults in nine diverse countries , ( Brazil , Haiti , Peru , Thailand , India , Malawi , South Africa , Zimbabwe and the United States ) .


We evaluated the change between baseline serum vitamin D levels and vitamin D levels @ and @ weeks after cART initiation .


Serum vitamin D levels decreased significantly from baseline to @ weeks among those randomized to efavirenz/lamivudine/zidovudine ( mean change : -@ -LSB- @ % Confidence Interval ( CI ) -@ , -@ -RSB- ng/ml ) and efavirenz/emtricitabine/tenofovir-DF ( mean change : -@ -LSB- @ % CI -@ , -@ -RSB- ng/ml ) when compared to those randomized to atazanavir/emtricitabine/didanosine-EC ( mean change : -@ -LSB- @ % CI -@ , @ -RSB- ng/ml ) .


Vitamin D levels did not change significantly between week @ and @ .


Other factors that significantly affected serum vitamin D change included country ( p < @ ) , season ( p < @ ) and baseline vitamin D level ( p < @ ) .


Efavirenz-containing cART regimens adversely affected vitamin D levels in patients from economically , geographically and racially diverse resource-limited settings .


This effect was most pronounced early after cART initiation .


Research is needed to define the role of Vitamin D supplementation in HIV care .


A collaborative care programme for depression in primary care has proven clinical effectiveness over a @-months period .


Because depression tends to relapse and to chronic course , our aim was to determine whether the effectiveness observed in the first year persists during @ years of monitoring .


Randomised controlled trial with twenty primary care centres were allocated to intervention group or usual care group .


The intervention consisted of a collaborative care programme with clinical , educational and organisational procedures .


Outcomes were monitored by a blinded interviewer at baseline , @ and @ months .


Clinical outcomes were response to treatment and remission rates , depression severity and health-related quality of life .


ISRCTN@ .


A total of @ adult patients with major depression ( DSM-IV ) were assessed at baseline .


At @ months , @ patients in the intervention group and @ in the control group were assessed ( attrition @ % ) .


The severity of depression ( mean Patient Health Questionnaire-@ score ) was @ points lower in the intervention group -LSB- @ versus @ ; p = @ -RSB- .


The treatment response rate was @ % higher in the intervention group than in the control group -LSB- @ % versus @ % ; p = @ -RSB- and the remission rate was @ % higher -LSB- @ % versus @ % ; p = @ -RSB- .


No difference reached statistical significance .


The number of patients lost ( @ % ) before follow-up may have introduced a bias .


Clinical benefits shown in the first year were not maintained beyond : at @ months the differences between the control group and the intervention group reduced in all the analysed variables .


The Carotid Revascularization Endarterectomy Versus Stenting Trial ( CREST ) is a multicenter randomized trial of stenting versus endarterectomy in patients with symptomatic and asymptomatic carotid disease .


This study assesses management of vascular risk factors .


Management was provided by the patient 's physician , with biannual monitoring results collected by the local site .


Therapeutic targets were low-density lipoprotein , cholesterol < @ mg/dL , systolic blood pressure < @ mm Hg , fasting blood glucose < @ mg/dL , and nonsmoking status .


Optimal control was defined as achieving all @ goals concurrently .


Generalized estimating equations were used to compare risk factors at baseline with those observed in scheduled follow-up visits for up to @ months .


In the analysis cohort of @ , significant improvements in risk-factor control were observed across risk factors for all follow-up visits compared with baseline .


At @ months , achievement of the low-density lipoprotein cholesterol goal improved from @ % to @ % ( P < @ ) , achievement of the systolic blood pressure goal improved from @ % to @ % ( P < @ ) , achievement of the glucose goal improved from @ % to @ % ( P = @ ) , and nonsmoking improved from @ % to @ % ( P < @ ) .


The percentage with optimal risk-factor control also improved significantly , from @ % to @ % ( P < @ ) , but nearly @ of @ study participants did not achieve optimal control during the study .


Site-based risk-factor control improved significantly in the first @ months and over the long term in CREST but was often suboptimal .


Intensive medical management should be considered for future trials of carotid revascularization .


To analyze the efficiency of the ALL-@ protocol ( ClinicalTrials.gov NCT@ @ ) in patients with T-cell leukemias , particularly the role of autologous hematopoietic stem cell transplantation ( auto-HSCT ) after non-myeloablative BEAM conditioning , followed by maintenance therapy .


Since @ , the ALL-@ study has enrolled @ patients with T-cell acute lymphoblastic leukemia ( T-ALL ) , the treatment results were assessed in @ patients : @ and @ patients underwent allogeneic HSCT and auto-HSCT , respectively .


A landmark analysis was used to compare survival rates in patients who had undergone auto-HSCT and in those who had not .


For this , the median time from complete remission to the date of auto-HSCT was determined ( the median was @ months ) .


Then to compare with the auto-HSCT group , only @ patients who had been in complete remission for @ months or more were included in a chemotherapy group .


The achievement of complete remission in patients with thymic T-ALL ( @ % ) was significantly higher than in those with early ( @ % ) or mature ( @ % ) variants .


The patients with early and mature T-ALL as compared to those with thymic T-ALL showed high death rates in the remission induction ( @ and @ % versus @ ) and the patients with mature T-ALL had a.higher proportion of refractory forms ( @ % versus @ ) .


The @-year overall and relapse-free survival rates in all the T-ALL patients were @ and @ % , respectively .


After auto-HSCT , the risk of recurrence was @ % versus @ % after chemotherapy ( p = @ ) .


The relapse-free survival rates significantly differed in the auto-HSCT and non-auto-HSCT groups : @ and @ % , respectively ( p = @ ) .


The long-term survival rates obtained during this multicenter study in the T-ALL patients treated according to the ALL-@ protocol , the basis for which is the principle of continuity of cytostatic effects , are exclusively optimistic .


Late consolidation with auto-HSCT following non-myeloablative BEAM conditioning , followed by maintenance therapy , considerably reduces the risk of recurrence .


Orphans and vulnerable children ( OVC ) are at high risk for experiencing trauma and related psychosocial problems .


Despite this , no randomized clinical trials have studied evidence-based treatments for OVC in low-resource settings .


To evaluate the effectiveness of lay counselor-provided trauma-focused cognitive behavioral therapy ( TF-CBT ) to address trauma and stress-related symptoms among OVC in Lusaka , Zambia .


This randomized clinical trial compared TF-CBT and treatment as usual ( TAU ) ( varying by site ) for children recruited from August @ , @ , through July @ , @ , and treated until December @ , @ , for trauma-related symptoms from @ community sites within Lusaka , Zambia .


Children were aged @ through @ years and had experienced at least one traumatic event and reported significant trauma-related symptoms .


Analysis was with intent to treat .


The intervention group received @ to @ sessions of TF-CBT ( n = @ ) .


The TAU group ( n = @ ) received usual community services offered to OVC .


The primary outcome was mean item change in trauma and stress-related symptoms using a locally validated version of the UCLA Posttraumatic Stress Disorder Reaction Index ( range , @-@ ) and functional impairment using a locally developed measure ( range , @-@ ) .


Outcomes were measured at baseline and within @ month after treatment completion or after a waiting period of approximately @ months after baseline for TAU .


At follow-up , the mean item change in trauma symptom score was -@ ( @ % CI , -@ to -@ ) , a reduction of @ % , for the TF-CBT group and -@ ( @ % CI , -@ to -@ ) , a reduction of @ % , for the TAU group .


The mean item change for functioning was -@ ( @ % CI , -@ to -@ ) , a reduction of @ % , and -@ ( @ % CI , -@ to -@ ) , a reduction of @ % , for the TF-CBT and TAU groups , respectively .


The difference in change between groups was statistically significant for both outcomes ( P < @ ) .


The effect size ( Cohen d ) was @ for trauma symptoms and @ for functioning .


Lay counselors participated in supervision and assessed whether the intervention was provided with fidelity in all @ community settings .


The TF-CBT adapted for Zambia substantially decreased trauma and stress-related symptoms and produced a smaller improvement in functional impairment among OVC having experienced high levels of trauma .


To compare the astigmatism-reducing effect of a toric intraocular lens ( IOL ) and peripheral corneal relaxing incisions ( PCRIs ) .


Moorfields Eye Hospital NHS Foundation Trust , London , United Kingdom .


Prospective masked bilateral randomized study .


Cataract patients with a preoperative corneal astigmatism of @ to @ diopters ( D ) were included .


All patients received a toric IOL in @ eye and a nontoric IOL plus a PCRI in the other eye .


Postoperative follow-up was at @ hour , @ month , and @ months .


The uncorrected distance visual acuity , corrected distance visual acuity , autorefraction ( Topcon RM-@ ) , and subjective refraction were recorded .


The IOL axis was assessed using retroillumination photographs .


The study enrolled @ eyes of @ patients .


The mean astigmatism vector reduction was @ D @ ( SD ) in the toric IOL group and @ @ D in the PCRI group ; the difference was statistically significant ( P = @ ) .


The mean absolute rotation of the toric IOL was @ @ degrees ( maximum @ degrees ) in the first @ postoperative months .