6g milk protein ; n = 10 ) , immediately after unilateral resistance exercise .


Postprandial mixed muscle protein fractional synthesis rate ( FSR ) was measured over 4h using a tracer infusion protocol with L - [ ring-C ] - phenylalanine and regular blood and muscle sampling .


FSR was significantly higher overall after EXP ( 0.07800.0070 % / h ) vs CONTROL ( 0.05740.0066 % / h ( EMMSE ) ) ( p = 0.049 ) .


No interaction between treatment and exercise was observed ( p = 0.519 ) .


Higher postprandial concentrations of EAA and leucine are possible mediating factors for the FSR response , while plasma insulin increase did not dictate the FSR response .


Moreover , when the protein intake from the supplements was expressed per kg leg lean mass ( LLM ) , a significant correlation was observed with resting postprandial FSR ( r = 0.48 , P = 0.038 ) .


Ingestion of a high whey protein , leucine-enriched supplement resulted in a larger overall postprandial muscle protein synthesis rate in healthy older subjects compared with a conventional dairy product .


This acute effect is promising for long-term effects on parameters of muscle mass , strength and function in sarcopenic older people , which requires further study .


This trial is registered in the Dutch Trial Register under number NTR1823 .


To determine the effectiveness of a pedometer-based telephone lifestyle coaching intervention on weight and physical activity .


A randomized controlled trial was conducted with 313 patients referred to cardiac rehabilitation in rural and urban Australia .


Participants were allocated to a healthy weight ( HW ) ( 4 telephone coaching sessions on weight and physical activity ) or a physical activity ( PA ) intervention ( 2 telephone coaching sessions on physical activity ) .


Weight and physical activity were assessed by self-report at baseline , short-term ( 6-8 weeks ) , and medium-term ( 6-8 months ) .


More than 90 % of participants completed the trial .


Over the medium-term , participants in the HW group decreased their weight compared with participants in the PA group ( P = .005 ) .


Participants in the HW group with a body mass index of 25 kg/m had a mean weight loss of 1.6 kg compared with participants in the PA-only group who lost a mean of 0.4 kg ( P = .015 ) .


Short-term , both groups increased their physical activity time , and the PA group maintained this increase at the medium-term .


Participants in the HW group achieved modest improvements in weight , and those in the PA group demonstrated increased physical activity .


Low-contact , telephone-based interventions are a feasible means of delivering lifestyle interventions for underserved rural communities , for those not attending cardiac rehabilitation , or as an adjunct to cardiac rehabilitation .


To compare the kinematics of lower limb joints between individuals with and without chronic ankle instability ( CAI ) during cross-turn and - cutting movements .


Cross-sectional study .


Motion analysis laboratory .


Twelve subjects with CAI and twelve healthy controls .


Hip flexion , adduction , and internal rotation , knee flexion , and ankle dorsiflexion and inversion angles were calculated in the 200ms before initial ground contact and from initial ground contact to toe-off ( stance phase ) in a cross-turn movement during gait and a cross-cutting movement from a forward jump , and compared across the two groups .


In the cross-cutting movement , the CAI group exhibited greater hip and knee flexion than the control group during the stance phase , and more hip abduction during the period before initial contact and the stance phase .


In the cross-turn movement the joint kinematics were similar in the two groups .


CAI subjects exhibited an altered pattern of the proximal joint kinematics during a cross-cutting movement .


It is important for clinicians to assess the function of the hip and knee as well as the ankle , and to incorporate coordination training for the entire lower limb into rehabilitation after lateral ankle sprains .


It is thought that therapy should be functional , be highly repetitive , and promote afferent input to best stimulate hand motor recovery after stroke , yet patients struggle to access such therapy .


We developed the MusicGlove , an instrumented glove that requires the user to practice gripping-like movements and thumb-finger opposition to play a highly engaging , music-based , video game .


The purpose of this study was to 1 ) compare the effect of training with MusicGlove to conventional hand therapy 2 ) determine if MusicGlove training was more effective than a matched form of isometric hand movement training ; and 3 ) determine if MusicGlove game scores predict clinical outcomes .


12 chronic stroke survivors with moderate hemiparesis were randomly assigned to receive MusicGlove , isometric , and conventional hand therapy in a within-subjects design .


Each subject participated in six one-hour treatment sessions three times per week for two weeks , for each training type , for a total of 18 treatment sessions .


A blinded rater assessed hand impairment before and after each training type and at one-month follow-up including the Box and Blocks ( B & B ) test as the primary outcome measure .


Subjects also completed the Intrinsic Motivation Inventory ( IMI ) .


Subjects improved hand function related to grasping small objects more after MusicGlove compared to conventional training , as measured by the B & B score ( improvement of 3.213.82 vs. -0.292.27 blocks ; P = 0.010 ) and the 9 Hole Peg test ( improvement of 2.142.98 vs. -0.851.29 pegs/minute ; P = 0.005 ) .


There was no significant difference between training types in the broader assessment batteries of hand function .


Subjects benefited less from isometric therapy than MusicGlove training , but the difference was not significant ( P > 0.09 ) .


Subjects sustained improvements in hand function at a one month follow-up , and found the MusicGlove more motivating than the other two therapies , as measured by the IMI .


MusicGlove games scores correlated strongly with the B & B score .


These results support the hypothesis that hand therapy that is engaging , incorporates high numbers of repetitions of gripping and thumb-finger opposition movements , and promotes afferent input is a promising approach to improving an individual 's ability to manipulate small objects .


The MusicGlove provides a simple way to access such therapy .


Current US healthcare delivery systems do not adequately address healthcare demands .


Physicians are integral but rarely emphasize prevention as a primary tool to change health outcomes .


Home visitation is an effective method for changing health outcomes in some populations .


The Florida International University Herbert Wertheim College of Medicine Green Family Foundation NeighborhoodHELP service-learning program assigns medical students to be members of interprofessional teams that conduct household visits to determine their healthcare needs .


We performed a prospective evaluation of 330 households randomly assigned to one of two groups : visitation from a student team ( intervention group ) or limited intervention ( control group ) .


The program design allowed randomly selected control households to replace intervention-group households that left the program of their own volition .


All of the households were surveyed at baseline and after 1 year of participation in the study .


After 1 year in the program and after adjustment for confounders , intervention group households proved more likely ( P 0.05 ) than control households to have undergone physical examinations , blood pressure monitoring , and cervical cytology screenings .


Cholesterol screenings and mammograms were borderline significant ( P = 0.05 and P = 0.06 , respectively ) .


This study supports the value of home visitation by interprofessional student teams as an effective way to increase the use of preventive health measures .


The study underscores the important role interprofessional student teams may play in improving the health of US communities , while students concurrently learn about primary prevention and primary care .


To observe the effect of detoxifying and blood circulation activating Chinese herb extraction of polygonum cuspidatum and hawthorn on carotid intima-media thickness ( IMT ) , plaque integral and plaque stability related serum indexes of patients with carotid atherosclerosis .


Sixty and four cases of carotid artery atherosclerosis patients were assigned randomly to 2 groups : detoxifying and blood circulation activating treatment group ( treatment group , 32 cases ) and control group ( 32 cases ) .


Patients in treatment group were treated with capsules of extraction of polygonum cuspidatum and hawthorn , 1 pill po , bid ( dosage of administration : polygonum cuspidatum extraction 5.33 mg x kg ( -1 ) x d ( -1 ) , hawthorn extraction 5.0 mg x kg ( -1 ) x d ( -1 ) ) ; patients in control group were treated with lovastatin 20 mg po , qd ( dosage of administration : 0.33 mg x kg ( -1 ) x d ( -1 ) ) .


The course of treatment was six months .


To observe changes of IMT , plaque integral , and detect the level of plaque stability related serum indexes such as Hs-CRP , MMP-1 and TIMP-1 .


After 6 months of treatment , in control group one patient quit the clinical trial because of liver dysfunction and one patient was rejected because of having not followed the therapeutic regimen .


32 cases in treatment group and 30 cases in control group were analyzed .


The results showed that IMT and plaque integral of treatment group decreased significantly after the treatment ( P < 0.05 , P < 0.01 ) , and there was no significant difference compared with control grope .


Serum Hs-CRP , MMP-1 and MMP-1 / TIMP-1 decreased after the treatment ( P < 0.05 , P < 0.01 ) , and the treatment group was superior to control group in decreasing serum Hs-CRP ( P < 0.05 ) .


Detoxifying and blood circulation activating Chinese herb extraction of polygonum cuspidatum and hawthorn has good effect of anti-atherosclerosis and promoting plaque stability .


Its mechanism might be related with anti-inflammation and inhibiting degradation of extracellular matrix , and deserves further studies .


Hip fractures are a leading cause of mortality and disability worldwide , and the number of hip fractures is expected to rise to over 6 million per year by 2050 .


The optimal approach for the surgical management of displaced femoral neck fractures remains unknown .


Current evidence suggests the use of arthroplasty ; however , there is lack of evidence regarding whether patients with displaced femoral neck fractures experience better outcomes with total hip arthroplasty ( THA ) or hemiarthroplasty ( HA ) .


The HEALTH trial compares outcomes following THA versus HA in patients 50years of age or older with displaced femoral neck fractures .


HEALTH is a multicentre , randomised controlled trial where 1434 patients , 50years of age or older , with displaced femoral neck fractures from international sites are randomised to receive either THA or HA .


Exclusion criteria include associated major injuries of the lower extremity , hip infection ( s ) and a history of frank dementia .


The primary outcome is unplanned secondary procedures and the secondary outcomes include functional outcomes , patient quality of life , mortality and hip-related complications-both within 2years of the initial surgery .


We are using minimisation to ensure balance between intervention groups for the following factors : age , prefracture living , prefracture functional status , American Society for Anesthesiologists ( ASA ) Class and centre number .


Data analysts and the HEALTH Steering Committee are blinded to the surgical allocation throughout the trial .


Outcome analysis will be performed using a ( 2 ) test ( or Fisher 's exact test ) and Cox proportional hazards modelling estimate .


All results will be presented with 95 % CIs .


The HEALTH trial has received local and McMaster University Research Ethics Board ( REB ) approval ( REB # : 06-151 ) .


Outcomes from the primary manuscript will be disseminated through publications in academic journals and presentations at relevant orthopaedic conferences .


We will communicate trial results to all participating sites .


Participating sites will communicate results with patients who have indicated an interest in knowing the results .


The HEALTH trial is registered with clinicaltrials.gov ( NCT00556842 ) .


To observe the difference in the analgesic effect on primary dysmenorrheal between acupuncture and sham acupuncture at Sanyinjiao ( SP 6 ) during menstrual pain and evaluate the impact of psychological effect on acupuncture analgesia .


Sixty subjects were randomized into an acupuncture group and a sham acupuncture group , 30 cases in each one .


The conventional acupuncture and sham acupuncture were applied to Sanyinjiao ( SP 6 ) on bilateral sides when menstrual pain began to attack and needles were retained for 30 min each time .


Three menstrual cycles were required .


The visual analogue scale ( VAS ) was adopted to determine the scores before and 0.5 h , 1 h , 3 h , 6 h and 12 h after acupuncture during menstrual pain in each cycle separately .


In the acupuncture group , VAS score at each time point after acupuncture was reduced as compared with that at the previous one during menstrual pain in each menstrual cycle , indicating the significant difference ( all P < 0.05 ) .


In the sham acupuncture group , the scores in 6 h and 12 h of acupuncture were reduced as compared with the previous one , indicating the significant difference ( all P < 0.05 ) .


After acupuncture , VAS score at each time point in the acupuncture group was lower than that in the sham acupuncture group ( all P < 0.05 ) .


The conventional acupuncture at Sanyinjiao ( SP 6 ) achieves the significant analgesic effect on primary dysmenorrheal .


The psychological placebo effect of sham acupuncture has no obvious impact on acupuncture analgesia .


The first multicenter randomized controlled trial was designed and conducted to assess the safety and effectiveness of totally percutaneous endovascular aortic aneurysm repair ( PEVAR ) with use of a 21F endovascular stent graft system and either an 8 F or 10 F suture-mediated closure system ( the PEVAR trial , NCT01070069 ) .


A noninferiority trial design was chosen to compare percutaneous access with standard open femoral exposure .


Between 2010 and 2012 , 20 U.S. institutions participated in a prospective , Food and Drug Administration-approved randomized trial to evaluate percutaneous femoral artery access and closure by a `` preclose '' technique in conjunction with endovascular abdominal aortic aneurysm repair .


A total of 151 patients were allocated by a 2:1 design to percutaneous access/closure ( n = 101 ) or open femoral exposure ( n = 50 [ FE ] ) .


PEVAR procedures were performed with either the 8 F Perclose ProGlide ( n = 50 [ PG ] ) or the 10 F Prostar XL ( n = 51 [ PS ] ) closure devices .


All endovascular abdominal aortic aneurysm repair procedures were performed with the Endologix 21 F profile ( outer diameter ) sheath-based system .


Patients were screened by computed tomography with three-dimensional reconstruction and independent physician review for anatomic suitability and adequate femoral artery anatomy for percutaneous access .


The primary trial end point ( treatment success ) was defined as procedural technical success and absence of major adverse events and vascular complications at 30 days .


An independent access closure substudy evaluated major access-related complications .


Clinical utility and procedural outcomes , ankle-brachial index , blood laboratory analyses , and quality of life were also evaluated with continuing follow-up to 6 months .


Baseline characteristics were similar among groups .


Procedural technical success was 94 % ( PG ) , 88 % ( PS ) , and 98 % ( FE ) .


One-month primary treatment success was 88 % ( PG ) , 78 % ( PS ) , and 78 % ( FE ) , demonstrating noninferiority vs FE for PG ( P = .004 ) but not for PS ( P = .102 ) .


Failure rates in the access closure substudy analyses demonstrated noninferiority of PG ( 6 % ; P = .005 ) , but not of PS ( 12 % ; P = .100 ) , vs FE ( 10 % ) .


Compared with FE , PG and PS yielded significantly shorter times to hemostasis and procedure completion and favorable trends in blood loss , groin pain , and overall quality of life .


Initial noninferiority test results persist to 6 months , and no aneurysm rupture , conversion to open repair , device migration , or stent graft occlusion occurred .


Among trained operators , PEVAR with an adjunctive preclose technique using the ProGlide closure device is safe and effective , with minimal access-related complications , and it is noninferior to standard open femoral exposure .


Training , experience , and careful application of the preclose technique are of paramount importance in ensuring successful , sustainable outcomes .


The aim of this study was to investigate the efficacy of bladder training before removing the indwelling urinary catheter in patients with acute urinary retention ( AUR ) associated with benign prostatic hyperplasia ( BPH ) .


In total , 845 consecutive patients with their first episode of spontaneous AUR associated with BPH were enrolled in this prospective randomized controlled trial .


They were randomly assigned to be given either pharmacological treatment combined with bladder training or pharmacological treatment ( tamsulosin 0.2 mg and finasteride 5 mg once daily ) with free drainage of urinary catheter for 7 days , and a trial without catheter ( TWOC ) was performed .


Data on patients ' baseline demographics , history of BPH , International Prostate Symptom Score , prostate size , serum prostate-specific antigen , intravesical prostatic protrusion , TWOC success rates and related complications were collected and statistically analysed .


The two groups of spontaneous AUR patients with BPH were given pharmacological treatment combined with bladder training before catheter removal ( n = 440 ) or pharmacological treatment alone ( n = 405 ) for 7 days .


All 845 patients underwent a first TWOC with an overall success rate of 66.9 % after first 7 days ' catheterization ; TWOC was successful in 65.2 % of cases in the intervention group and 68.6 % in the control group .


There was no statistically significant difference in TWOC success rate between the two groups ( p > 0.05 ) .


This randomized controlled trial showed that bladder training before urinary catheter removal did not increase the chance of TWOC success significantly in spontaneous AUR patients with BPH .


Abstinence from chronic cocaine use is associated with abnormal sleep architecture .


As sleep abnormalities are associated with clinical outcome in alcohol dependence , we hypothesized a similar relationship in cocaine dependence .


We report data from a cocaine self-administration study ( N = 12 ) and the placebo arm of a randomized clinical trial ( N = 20 ) .


Self-administration participants underwent three cocaine self-administration sessions during a three-week inpatient stay .


Treatment participants underwent two weeks of inpatient followed by six weeks of outpatient treatment including once-weekly cognitive behavioral therapy .


Measurements included polysomnography from early and late in abstinence during the inpatient stays .


Clinical outcomes included amount of cocaine self-administered , urine tests , and self-reported use and withdrawal symptoms .


Change in slow-wave sleep from early to late abstinence ( SWS ; p = 0.05 ) , late abstinence rapid eye movement sleep ( REM ; p = 0.002 ) , and late abstinence total sleep time ( p = 0.02 ) were negatively correlated with the amount of cocaine self-administered .


Early abstinence REM was positively correlated with withdrawal symptoms ( p = 0.02 ) .


Late abstinence REM was positively correlated with percent negative urines and maximum consecutive number of days abstinent ( both p < 0.001 ) .


SWS was positively correlated with percent negative urines ( p = 0.03 ) and participants with increased SWS had greater percent negative urines ( p = 0.008 ) and maximum consecutive number of days abstinent ( p = 0.009 ) .


Correlations between sleep deficits and amount of cocaine self-administered , clinical outcomes , and severity of withdrawal symptoms underscore the relevance of sleep in clinical outcomes in the treatment of cocaine dependence .


Randomized trial with a concurrent observational cohort study .


To compare 8-year outcomes of surgery with nonoperative care for symptomatic lumbar spinal stenosis .


Surgery for spinal stenosis has been shown to be more effective than nonoperative treatment during 4 years , but longer-term data are less clear .


Surgical candidates from 13 centers in 11 US states with at least 12 weeks of symptoms and confirmatory imaging were enrolled in a randomized cohort or observational cohort .


Treatment was standard , decompressive laminectomy versus standard nonoperative care .


Primary outcomes were SF-36 ( MOS 36-Item Short-Form Health Survey ) Bodily Pain and Physical Function scales and the modified Oswestry Disability Index assessed at 6 weeks , 3 months , 6 months , and yearly up to 8 years .


Data were obtained for 55 % of participants in the randomized group and 52 % of participants in the observational group at the 8-year follow-up .


Intent-to-treat analyses showed no differences between randomized cohorts ; however , 70 % of those randomized to surgery and 52 % of those randomized to nonoperative had undergone surgery by 8 years .


As-treated analyses in the randomized group showed that the early benefit for surgery out to 4 years converged over time , with no significant treatment effect of surgery seen in years 6 to 8 for any of the primary outcomes .


In contrast , the observational group showed a stable advantage for surgery in all outcomes between years 5 and 8 .


Patients who were lost to follow-up were older , less well-educated , sicker , and had worse outcomes during the first 2 years in both surgical and nonoperative arms .


Patients with symptomatic spinal stenosis show diminishing benefits of surgery in as-treated analyses of the randomized group between 4 and 8 years , whereas outcomes in the observational group remained stable .


Loss to follow-up of patients with worse early outcomes in both treatment groups could lead to overestimates of long-term outcomes but likely not bias treatment effect estimates .


Controlled , repeated-measures , single-blind randomized study .


To determine the effect of cervical or thoracic manipulation on neurotensin , oxytocin , orexin A , and cortisol levels .


Previous studies have researched the effect of spinal manipulation on pain modulation and/or range of movement .


However , there is little knowledge of the biochemical process that supports the antinociceptive effect of spinal manipulation .


Thirty asymptomatic subjects were randomly divided into 3 groups : cervical manipulation ( n = 10 ) , thoracic manipulation ( n = 10 ) , and nonmanipulation ( control ) ( n = 10 ) .


Blood samples were extracted before , immediately after , and 2 hours after each intervention .


Neurotensin , oxytocin , and orexin A were determined in plasma using enzyme-linked immuno assay .


Cortisol was measured by microparticulate enzyme immuno assay in serum samples .


Immediately after the intervention , significantly higher values of neurotensin ( P < .05 ) and oxytocin ( P < .001 ) levels were observed with both cervical and thoracic manipulation , whereas cortisol concentration was increased only in the cervical manipulation group ( P < .05 ) .


No changes were detected for orexin A levels .


Two hours after the intervention , no significant differences were observed in between-group analysis .


The mechanical stimulus provided by spinal manipulation triggers an increase in neurotensin , oxytocin , and cortisol blood levels .


Data suggest that the initial capability of the tissues to tolerate mechanical deformation affects the capacity of these tissues to produce an induction of neuropeptide expression .


To identify the risk-predictive baseline profile patterns of demographic , genetic , immunologic , and metabolic markers and synthesize these patterns for risk prediction .


RuleFit is used to identify the risk-predictive baseline profile patterns of demographic , immunologic , and metabolic markers , using 356 subjects who were randomized into the control arm of the prospective Diabetes Prevention Trial-Type 1 ( DPT-1 ) study .


A novel latent trait model is developed to synthesize these baseline profile patterns for disease risk prediction .


The primary outcome was Type 1 Diabetes ( T1D ) onset .


We identified ten baseline profile patterns that were significantly predictive to the disease onset .


Using these ten baseline profile patterns , a risk prediction model was built based on the latent trait model , which produced superior prediction performance over existing risk score models for T1D .


Our results demonstrated that the underlying disease progression process of T1D can be detected through some risk-predictive patterns of demographic , immunologic , and metabolic markers .


A synthesis of these patterns provided accurate prediction of disease onset , leading to more cost-effective design of prevention trials of T1D in the future .


Vitamin D is a potent immunomodulator , but its impact on morbidity and mortality among infants remains unclear .


The objective of the study was to prospectively assess the association of vitamin D status with mortality , morbidity , and growth during the first 2 y of life .


A prospective cohort of 253 HIV-infected and 948 HIV-exposed Tanzanian infants enrolled in a randomized trial of multivitamins ( not including vitamin D ) was studied .


Serum 25-hydroxyvitamin D [ 25 ( OH ) D ] concentrations were measured at 5-7 wk of age and infants were followed at monthly clinic visits until 24 mo. .


Physicians performed a clinical exam every 3 mo or when an illness was noted .


Serum 25 ( OH ) D concentrations were ( means SDs ) 18.6 10.3 ng/mL and 18.1 9.2 ng/mL for HIV-infected and HIV-exposed infants , respectively .


Unexpectedly , serum 25 ( OH ) D concentrations 30 ng/mL were significantly associated with higher mortality as compared to the 20-29 .9 ng/mL reference for HIV-infected ( HR : 2.47 ; 95 % CI : 1.13 , 5.44 ; P = 0.02 ) and HIV-exposed ( HR : 4.00 ; 95 % CI : 1.67 , 9.58 ; P < 0.01 ) infants after multivariate adjustment .


We found no statistically significant association between 25 ( OH ) D concentrations < 10 ng/mL and mortality for HIV-infected ( HR : 1.43 ; 95 % CI : 0.74 , 2.78 ; P = 0.29 ) and HIV-exposed ( HR : 1.56 ; 95 % CI : 0.60 , 4.03 ; P = 0.36 ) infants .


Among HIV-exposed infants , 25 ( OH ) D concentrations 30 ng/mL were significantly associated with clinical [ incidence ratio rate ( IRR ) : 1.34 ; 95 % CI : 1.06,1.70 ; P = 0.02 ] and confirmed ( IRR : 1.71 ; 95 % CI : 1.71 ; 1.15 , 2.54 ; P < 0.01 ) malaria diagnoses , whereas concentrations of < 10 ng/mL were associated with oral candidiasis ( IRR : 1.47 ; 95 % CI : 1.00-2 .15 ; P = 0.046 ) and wasting ( HR : 1.71 ; 95 % CI : 1.20 , 2.43 ; P < 0.01 ) .


The observational design of this study does not allow for causal interpretation ; however , the results indicate a strong need for additional studies of vitamin D among HIV-infected and - exposed children , particularly in malaria-endemic settings .


The parent trial was registered at clinicaltrials.gov as NCT00197730 .


Benzodiazepines , other anxiolytics , or sedative hypnotics are prescribed for 30 % -50 % of posttraumatic stress disorder ( PTSD ) patients .


Prior data and theory suggest that these medications may inhibit response to exposure therapy , one of the most effective PTSD treatments .


The present post hoc study reanalyzed results from a psychotherapy trial to assess whether benzodiazepine use was associated with reduced response to exposure therapy .


Between August 2002 and October 2005 , 283 female veterans and soldiers meeting DSM-IV criteria for PTSD were randomly assigned to 10 weekly 90-minute sessions of either prolonged exposure ( n = 140 ) or present-centered psychotherapy ( n = 143 ) .


Benzodiazepine use ( n = 57 ) or non-use ( n = 226 ) at intake was not randomly assigned .


Multilevel modeling was used to assess the effects of benzodiazepine status , psychotherapy condition , and their interaction on changes on the Clinician-Administered PTSD Scale and the PTSD Checklist during the treatment and 6-month follow-up periods .


Consistent with prior reports from these data , prolonged exposure psychotherapy produced greater reductions per week in PTSD symptoms than did present-centered psychotherapy ( b = -0.48 , P = .02 ) .


Patients prescribed benzodiazepines did not have weaker response to prolonged exposure , but demonstrated poorer posttreatment maintenance of gains from present-centered psychotherapy ( b = -0.78 , P < .001 ) .


Prolonged exposure is a sufficiently robust treatment that patients who are taking benzodiazepines can benefit from it .


It is unclear whether benzodiazepine use or other patient factors accounted for benzodiazepine recipients ' poorer maintenance of gains in present-centered psychotherapy .


ClinicalTrials.gov identifier : NCT00032617 .


The effects of hypoxic training on exercise performance remain controversial .


Here , we tested the hypotheses that i ) hypoxic training possesses ergogenic effects at sea level and altitude and ii ) the benefits are primarily mediated by improved mitochondrial function of the skeletal muscle .


We determined aerobic performance ( incremental test to exhaustion and time trial for a set amount of work ) in moderately trained subjects undergoing 6 wk of endurance training ( 3-4 times per week , 60 min per session ) in normoxia ( placebo , n = 8 ) or normobaric hypoxia ( FIO2 = 0.15 , n = 9 ) using a double-blind and randomized design .


Exercise tests were performed in normoxia and acute hypoxia ( FIO2 = 0.15 ) .


Skeletal muscle mitochondrial respiratory capacities and electron coupling efficiencies were measured via high-resolution respirometry .


Total hemoglobin mass was assessed by carbon monoxide rebreathing .


Skeletal muscle respiratory capacity was not altered by training or hypoxia ; however , electron coupling control respective to fat oxidation slightly diminished with hypoxic training .


Hypoxic training did increase total hemoglobin mass more than the placebo ( 8.4 % vs 3.3 % , P = 0.02 ) .


In normoxia , hypoxic training had no additive effect on maximal measures of oxygen uptake or time trial performance .


In acute hypoxia , hypoxic training conferred no advantage on maximal oxygen uptake but tended to enhance time trial performance more than normoxic training ( 52 % vs 32 % , P = 0.09 ) .


Our data suggest that , in moderately trained subjects , 6 wk of hypoxic training possesses no ergogenic effect at sea level .


It is not excluded that hypoxic training might facilitate endurance capacity at moderate altitude ; however , this issue is still open and needs to be further examined .


In this randomized trial , Project CARE , we examined whether participation in a cognitive-behavioral stress management and breast cancer wellness and education program improved psychological outcomes among a sample of underserved black breast cancer survivors .


Both complementary medicine interventions were 10-sessions , manualized , group-based , and were culturally adapted for black women in the community from evidence-based interventions .


Participants were 114 black women ( mean age = 51.1 , 27-77 years ) who had completed breast cancer treatment 0-12 months before enrollment ( stages 0-IV , mean time since cancer diagnosis = 14.1 months ) .


Women were enrolled upon completion of curative treatment ( ie , surgical , chemotherapy , radiation oncology ) and randomized to receive cognitive-behavioral stress management or cancer wellness and education program .


There was a remarkable 95 % retention rate from baseline to 6-month follow-up .


Participants in both conditions showed statistically significant improvement on indices of psychological well-being , including overall quality of life ( Functional Assessment of Cancer Therapy-Breast ) , intrusive thoughts ( Impact of Event Scale-Revised ) , depressive symptoms ( Center for Epidemiologic Studies-Depression ) , and stress levels ( Perceived Stress Scale ) over the 6-month postintervention follow-up ( all repeated measures analysis of variance within-subjects time effects : P < .05 , except for overall mood ; Profile of Mood States-Short Version ) .


Contrary to hypotheses , however , condition time effects were not statistically significant .


Findings suggest that improvements in multiple measures over time may have been due to intensive training in stress management , extensive provision of breast cancer information , or participation in an ongoing supportive group of individuals from a similar racial background .


Implications bear on decisions about appropriate control groups , the timing of intervention delivery during the treatment trajectory , and perceived support from the research team .


The treatment of acne can be difficult , with suboptimal adherence resulting in poor treatment outcomes .


To determine whether demonstrating to patients how to properly apply a topical acne medication through the use of a sample product will improve adherence .


Subjects with mild to moderate acne were instructed to use adapalene/benzoyl peroxide gel once daily for six weeks .


Subjects were randomized into sample or no sample group .


Sample group received a demonstration on how to apply the medication using a product sample .


The primary outcome was median adherence , recorded using electronic monitoring , and secondary outcomes were efficacy measures including the Acne Global Assessment ( AGA ) and lesion counts and the Perceived Medical Condition Self-Management Scale ( PMCSMS ) .


Data from 17 patients was collected and analyzed .


Median adherence rates were 50 % in the sample group and 35 % in the no sample group ( p = 0.67 ) .


The median percent improvement in non-inflammatory lesions were 46 % for the sample group and 33 % for the no-sample group ( p = 0.10 ) .


The small size of this pilot study limited the extent of subgroup analyses .


Objective electronic monitoring expanded our previous observations of poor adherence in the treatment of acne .


There is a considerable potential effect size on adherence for the use of samples , supporting the need for future , well powered studies to assess the value of using samples in the treatment of acne and other dermatologic skin diseases .


High blood pressure ( BP ) is commonly not diagnosed , and patients do not achieve target values when treated .


Among 20,000 patients encompassing most races-ethnicities , we evaluated BP measurements and treatment response in a stroke prevention trial .


Our goal was to identify BP measurement differences between clinical trial and patient determinations and among the racial-ethnic groups .


A total of 20,332 patients with ischemic stroke were randomized to receive antiplatelet treatment and 80 mg of telmisartan versus placebo .


BP measurements were obtained at the first clinic visit and then 1 and 3 months later and every 6 months thereafter .


One week after the first clinic visit , patients were requested to report a BP measurement obtained elsewhere .


Measurements at the trial clinics were obtained with the same electronic device .


Statistical analysis was used to detect significant differences .


The mean patient age was 66 years ; 36 % were women , and race-ethnicity comprised 58 % Whites , 33 % Asian , 4.9 % Hispanic , and 4 % Black .


Overall , 74 % of patients were hypertensive .


BP varied between the race-ethnicity groups , being highest in Hispanics ( 145/85 ) and lowest in Blacks ( 144/82 ) .


BP at visits clinic 1 , nonclinic 1A , and clinic 2 were , respectively , 144/84 , 137/80 , and 139/81 mmHg , with the difference between visits 1-2 and visit 1A being significant .


BPs were normal in 42 % of the cases at visit 1A , and of these , only 44 % were normal at visit 1 and 57.6 % were normal on visit 2 .


Similar findings were noted for all race-ethnicity groups .


BP values varied among race-ethnicities and showed differences between clinic and patient measurements .


This finding questions the reliability of self-reported BP and has implications for BP management in daily clinical practice .


To assess the incremental cost and cost-effectiveness of continuous and discontinuous regimens of bevacizumab ( Avastin ) and ranibizumab ( Lucentis ) for neovascular age-related macular degeneration ( nAMD ) from a UK National Health Service ( NHS ) perspective .


A within-trial cost-utility analysis with a 2-year time horizon , based on a multicentre factorial , non-inferiority randomised controlled trial .


23 hospital ophthalmology clinics .


610 patients aged 50years with untreated nAMD in the study eye .


0.5 mg ranibizumab or 1.25 mg bevacizumab given continuously ( monthly ) or discontinuously ( as-needed ) for 2years .


Quality-adjusted life-years ( QALYs ) .


Total 2-year costs ranged from 3002/patient ( $ 4700 ; 95 % CI 2601 to 3403 ) for discontinuous bevacizumab to 18590/patient ( $ 29106 ; 95 % CI 18258 to 18922 ) for continuous ranibizumab .


Ranibizumab was significantly more costly than bevacizumab for both continuous ( +14989 / patient ( $ 23468 ) ; 95 % CI 14522 to 15456 ; p < 0.001 ) and discontinuous treatment ( +8498 ( $ 13305 ) ; 95 % CI 7700 to 9295 ; p < 0.001 ) , with negligible difference in QALYs .


Continuous ranibizumab would only be cost-effective compared with continuous bevacizumab if the NHS were willing to pay 3.5 million ( $ 5.5 million ) per additional QALY gained .


Patients receiving continuous bevacizumab accrued higher total costs ( +599 ( $ 938 ) ; 95 % CI 91 to 1107 ; p = 0.021 ) than those receiving discontinuous bevacizumab , but also accrued non-significantly more QALYs ( +0.020 ; 95 % CI -0.032 to 0.071 ; p = 0.452 ) .


Continuous bevacizumab therefore cost 30220 ( $ 47316 ) per QALY gained versus discontinuous bevacizumab .


However , bootstrapping demonstrated that if the NHS is willing to pay 20000/QALY gained , there is a 37 % chance that continuous bevacizumab is cost-effective versus discontinuous bevacizumab .


Ranibizumab is not cost-effective compared with bevacizumab , being substantially more costly and producing little or no QALY gain .


Discontinuous bevacizumab is likely to be the most cost-effective of the four treatment strategies evaluated in this UK trial , although there is a 37 % chance that continuous bevacizumab is cost-effective .


ISRCTN92166560 .


To evaluate two low-dose volumes ( 20 mL or 30 mL ) of 1.5 % mepivacaine solution used for ultrasound-guided axillary blockade for outpatients undergoing distal upper limb surgery .


Prospective , double-blinded randomized study .


Outpatient surgical setting of a university-affiliated hospital .


64 adult , ASA physical status 1 , 2 , and 3 patients , aged 28-46 years , scheduled for upper limb surgery .


Patients were randomized to two groups to receive either 20 mL of 1.5 % mepivacaine solution ( n = 31 ) or 30 mL of 1.5 % mepivacaine solution ( n = 33 ) for ultrasound-guided axillary plexus blockade .


Block duration , proportion of surgical and functional successful blocks , onset of sensory and motor blockade measured from 0 to 30 minutes following final needle extraction , total amount of preoperative sedative ( midazolam ) , and intraoperative propofol administered were recorded .


Following axillary plexus blockade , neither patient group showed any statistically significant difference in the percentage of functionally successful blockade ( 30 mL , 100 % : 20 mL , 97 % ; P = 0.48 ) , surgically successful blockade ( 30 mL , 100 % ; 20 mL , 94 % ; P = 0.23 ) , cumulative sensory or motor blockade surgical time , block performance time , preoperative midazolam use , or intraoperative propofol use .


Low volumes ( 30 mL or 20 mL ) of 1.5 % mepivacaine provides satisfactory anesthesia for ambulatory distal upper limb surgery with no significant difference in clinical outcomes .


To assess the effect of dimeticone and pepsin on the bioavailability of metoclopramide ( CAS 7232-21-5 ) in healthy volunteers .


The study was conducted using a randomized , open , 2-period crossover design .


The volunteers received single administration of 7-mg conventional metoclopramide capsule and a formulation containing metoclopramide ( 7mg ) plus dimeticone ( 40mg ) and pepsin ( 50mg ) , with a 7-day interval between treatments .


Serial blood samples were collected before dosing and during 24h post-treatment .


Plasma metoclopramide concentrations were analyzed by liquid chromatography coupled with tandem mass spectrometry ( LC-MS/MS ) .


The pharmacokinetics parameters AUC ( last ) and C ( max ) were obtained from the metoclopramide plasma concentration vs. time curves .


Metoclopramide 's association was bioequivalent to conventional capsule ; 90 % CIs for geometric mean treatment ratios of C ( max ) [ 108.0 % ( 90 % CI , 100.4-116 .3 % ) ] , AUC ( last ) [ 103.3 % ( 90 % CI , 99.5-107 .4 % ) ] were within the predefined range .


The metoclopramide formulations were well tolerated at the administered doses and no significant adverse reactions were observed .


Thus , these results confirm the good bioavailability of metoclopramide in the new formulation and rule out any impaired absorption when the drugs are formulated in combination .


Esophageal variceal bleed is a major problem in patients with cirrhosis .


Endoscopic variceal ligation ( EVL ) has been shown to be equal to or better than propranolol in preventing first bleed .


Carvedilol is a non-selective blocker with alpha-1 adrenergic blocker activity .


Hemodynamic studies have shown carvedilol to be more effective than propranolol at reducing portal pressure .


We compared efficacy of carvedilol with EVL for primary prophylaxis of esophageal variceal bleed .


Cirrhotic patients with esophageal varices were randomized to carvedilol 12.5 mg daily or EVL at three university hospitals of Pakistan .


End points were esophageal variceal bleeding , death or liver transplant .


Two hundred and nine patients were evaluated .


Eighty two and eighty six patients were randomized in carvedilol and EVL arms respectively .


Mean age was 48 12.2 years ; 122 ( 72.7 % ) were males ; 89.9 % had viral cirrhosis ; mean Child-Pugh score was 7.3 1.6 and mean follow up was 13.3 12.1 months ( range 1-50 months ) .


Both EVL and carvedilol groups had comparable variceal bleeding rates ( 8.5 % vs. 6.9 % ) , bleed related mortality ( 4.6 % vs. 4.9 % ) and overall mortality ( 12.8 % vs. 19.5 % ) respectively .


Adverse events in carvedilol group were hypotension ( n = 2 ) , requiring cessation of therapy , while transient nausea ( n = 18 ) and dyspnea ( n = 30 ) resolved spontaneously .


In the EVL arm , post banding ulcer bleed ( n = 1 ) and chest pain ( n = 17 ) , were termed as serious adverse events while transient dysphagia ( n = 58 ) resolved without treatment .


Although our study is underpowered , the findings suggest that carvedilol is probably not superior to EVL in preventing first variceal bleed in patients with viral cirrhosis .


The aim of this study is to systematically investigate under standardized experimental conditions the effects of instrument contamination and wear on the quality of bipolar vessel sealing ( BVS ) achieved using a reusable instrument .


The study was designed as a prospective , randomized , and controlled in vitro study and conducted in an academic research environment .


Reusable bipolar coagulation forceps ( BiClamp 200 C , ERBE Elektromedizin ) were used to apply sealing pressures of 300-1 ,100 mN/mm ( 2 ) to 239 renal arteries from commercially slaughtered female pigs ( Swabian-Hall Swine ) .


Forceps jaws were coated with porcine blood , blood and collagen , or blood , collagen , and fat to simulate instrument contamination with biological material during surgery .


Clinical wear was mimicked by sandpaper abrasion .


The main outcome measures were seal success ( resistance to 250 mmHg intraluminal pressure for 2 min ) and seal stability ( burst pressure ) .


Sealing pressure had a significant impact , with 800 mN/mm ( 2 ) producing the best sealing results .


Seal success increased with total energy applied to the tissue , a higher maximum temperature , and longer coagulation as indicated by desiccation time .


Experimental contamination had no significant impact on seal success and only a limited effect on seal stability .


Similarly , abrasive wear also had no significant effect on either seal quality or seal strength .


The impact of bipolar forceps contamination and wear on seal success and quality was negligible in our in vitro model .


To achieve high-quality seals , it is essential to use adequate sealing pressures .


Our findings could have direct implications for the design and clinical handling of BVS instruments .


Antispasmodic agents have been used in the management of irritable bowel syndrome .


However , systematic reviews have come to different conclusions about the efficacy in irritable bowel syndrome .


Fenoverine acts as a synchronizer of smooth muscle in modulating the intracellular influx of calcium .


We compared fenoverine with trimebutine for the treatment of patients with IBS .


A multicenter , randomized , double-blind , non-inferiority clinical study was conducted to compared fenoverine with trimebutine .


Subjects were randomized to receive either fenoverine ( 100 mg three times a day ) or trimebutine ( 150 mg three times a day ) for 8 weeks .


A total of 197 patients were analyzed by the intention-to-treat approach .


The primary endpoint was the proportion of patients who had 30 % reduction in abdominal pain or discomfort measured by bowel symptom scale ( BSS ) score at week 8 compared to the baseline .


The secondary endpoints were changes of abdominal bloating , diarrhea , constipation , overall and total scores of BSS , and overall satisfaction .


At week 8 , fenoverine was shown to be non-inferior to trimebutine ( treatment difference , 1.76 % ; 90 % CI , -10.30 -13.82 ; p = 0.81 ) ; 69.23 % ( 54 of 78 patients ) of patients taking fenoverine and 67.47 % ( 56 of 83 patients ) of patients taking trimebutine showed 30 % reduction in abdominal pain or discomfort compared to the baseline .


There results of the secondary endpoints were also comparable between the fenoverine group and the trimebutine group .


Fenoverine is non-inferior to trimebutine for treating IBS in terms of both efficacy and tolerability .


To evaluate , by means of a prospective randomized study , the efficacy of cinacalcet in the forms of nephrolithiasis associated with primary hyperparathyroidism in both the hypercalcemic and normocalcemic variant .


Ten patients suffering from active nephrolithiasis associated with primary hyperparathyroidism ( 4 hypercalcemics and 6 normocalcemics ) , equally divided between males and females , were randomly but not blindly addressed to treatment with potassium citrate and allopurinol , or to the same therapeutic regimen in combination with cinacalcet .


The dosage of cinacalcet was optimized for each patient in order to obtain a reduction of parathyroid hormone ( PTH ) within normal limits while enabling the maintenance of adequate calcemic values .


All study participants were given the same diet based on a reduction in sodium intake , oxalate-rich foods and animal protein with standardized intake of calcium and an increase in hydration .


After a follow up period of 10 months , cinacalcet was associated to standard therapy and diet in patients who were not taken it , conversely cinacalcet was withdrawn in the remaining patients who remained on standard therapeutic regimen and diet .


Follow up was continued for a second period of observation of the same duration of the first .


At the end of the period of treatment with cinacalcet , for both variants of hyperparathyroidism , a statistically significant reduction in the overall number and in the diameter of renal stones was found .


This prospective randomized study shows the effectiveness of cinacalcet used in combination with a diet with normalized calcium intake , in reducing the number and size of urinary stones in hypercalemic and normocalcemic forms of primary hyperparathyroidism .


Levomilnacipran extended-release ( ER ) is an FDA-approved serotonin norepinephrine reuptake inhibitor ( SNRI ) for treating major depressive disorder ( MDD ) .


SF-36v2 Health Survey outcomes from a Phase III , randomized , double-blind , placebo-controlled study ( NCT00969709 ) were evaluated .


Prospective and post hoc analyses of SF-36 Mental and Physical Component Summaries ( MCS , PCS ) , and individual domains compared pooled levomilnacipran ER doses ( 40 , 80 , 120 mg/day ) with placebo .


Patients ( 18-65 years ) had MDD , depressive episode 8 weeks , and Montgomery-sberg Depression Rating Scale total score 30 .


SF-36 score changes from baseline to Week 8 were analyzed using ANCOVA and the observed cases approach ( Intent-to-Treat [ ITT ] Population ) .


Minimally important differences ( MID ) evaluated clinical relevance .


Baseline MCS scores reflected marked mental deficits in the ITT Population ( levomilnacipran ER = 529 ; placebo = 175 ) .


MCS change at Week 8 was significantly greater for levomilnacipran ER than placebo ( LSMD [ SE ] = 4.8 [ 1.5 ] ; P = 0.0011 ) ; MID exceeded the 3-point threshold .


Baseline PCS scores suggested minimal physical deficits ; no between-group difference at Week 8 was noted .


LSMD was nominally statistically significant ( P < 0.05 ) for levomilnacipran ER versus placebo in 5 domains ( General Health [ 2.44 ; P = 0.0010 ] , Vitality [ 2.48 ; P = 0.0307 ] , Social Functioning [ 3.25 ; P = 0.0097 ] , Role-Emotional [ 3.38 ; P = 0.0078 ] , Mental Health [ 4.34 ; P = 0.0005 ] ) ; changes in Vitality , Social Functioning , and Mental Health exceeded MID .


The trial was limited by short duration ; analyses were post hoc and adjustments were not made for multiplicity .


Statistically significant and clinically meaningful improvement on the MCS and several individual domains suggest overall and dimensional improvement in health-related functioning for patients with MDD treated with levomilnacipran ER versus placebo .


To compare best-corrected visual acuity ( BCVA ) and central macular thickness ( CMT ) after 532-nm subthreshold laser grid photocoagulation and threshold laser grid photocoagulation for the treatment of diabetic macular oedema ( DME ) .


Twenty-three patients ( 46 eyes ) with binocular DME were enroled in this study .


The two eyes of each patient were divided into a subthreshold photocoagulation group and a threshold photocoagulation group .


The eyes of the subthreshold group underwent 532-nm patter scan laser system ( PASCAL ) 50 % end point subthreshold laser grid photocoagulation therapy , whereas the threshold photocoagulation group underwent short-pulse grid photocoagulation with a 532-nm PASCAL system .


BCVA and CMT were assessed in all patients before treatment , 7 days after treatment , and 1 , 3 , and 6 months after treatment .


After grid photocoagulation , the mean BCVA improved in both the subthreshold group , and the threshold group , and the two groups did not differ statistically significantly from each other .


Similarly , the macular oedema diminished in both groups after treatment , and the two groups did not differ statistically significantly from each other with regard to CMT .


Both 532-nm subthreshold laser grid photocoagulation and threshold laser grid photocoagulation can improve the visual acuity and reduce CMT in DME patients .


The purpose of this study was to investigate the effects of massage therapy compared with occlusal splint therapy on mandibular range of motion ( ROM ) in individuals with temporomandibular disorder ( TMD ) and compare the results with ROM obtained in a group of individuals without this disorder .


A blinded randomized clinical trial was conducted .


Twenty-eight volunteers with TMD were randomly distributed into either a massage therapy group or an occlusal splint group .


Both treatments were provided for 4 weeks .


Fourteen individuals without TMD were consecutively allocated to a comparison group .


Fonseca anamnestic index was used to characterize TMD and allocate the volunteers to either of the intervention groups or asymptomatic comparison group .


Mandibular ROM was evaluated before and after treatment using a digital caliper .


Two-way repeated-measures analysis of variance with a post hoc Bonferroni testing was used for intergroup and intragroup comparisons ( level of significance was set to 5 % ) .


Cohen d was used to calculate the effect size .


In the intragroup analysis , significant increases in ROM were found for all measures in both the massage and occlusal splint groups ( P < .05 ) .


A small to moderate clinical effect of treatment with the occlusal splint was found regarding right and left lateral excursion in comparison with the massage therapy and asymptomatic comparison groups ( 0.2 < d < 0.5 ) .


Massage therapy on the masticatory muscles and the use of an occlusal splint lead to an increase in mandibular ROM similar to that of the asymptomatic comparison group with regard to maximum active mouth opening and both right and left excursion in individuals with TMD .


Evidence exists for the effectiveness of cognitive behaviour therapy for psychosis with moderate effect sizes , but the evidence for cognitive behaviour therapy specifically for distressing voices is less convincing .


An alternative symptom-based approach may be warranted and a body of literature has explored distressing voices from an interpersonal perspective .


This literature has informed the development of relating therapy and findings from a case series suggested that this intervention was acceptable to hearers and therapists .


An external pilot randomized controlled trial ( RCT ) comparing outcomes for 15 patients receiving 16hours ( weekly sessions of one hour ) of relating therapy and their usual treatment with 15 patients receiving only their usual treatment .


Participants will be assessed using questionnaires at baseline , 16weeks ( post-intervention ) , and 36weeks ( follow-up ) .


Expected outcomes will include a refined study protocol and an estimate of the effect size to inform the sample size of a definitive RCT .


If evidence from a fully powered RCT suggests that relating therapy is effective , the therapy will extend the range of evidence-based psychological therapies available to people who hear distressing voices .


Current Controlled Trials ISRCTN registration number 44114663 .


Registered on 13 June 2013 .


To identify genetic markers capable of predicting the pharmacokinetics , pharmacodynamics , and adverse effects of risperidone .


Genotyping was performed in 70 healthy volunteers receiving a single 1mg oral dose of risperidone .


Risperidone and hydroxyrisperidone plasma levels were measured using high-performance liquid chromatography combined with tandem mass spectrometry.Prolactin concentration was quantified by direct chemiluminescence .


Poor CYP2D6 metabolizers showed higher risperidone Cmax , area under the curve ( AUC ) , and t1/2 , as well as lower clearance .


They also showed lower Cmax and AUC and higher t1/2 for hydroxyrisperidone .


Furthermore , individuals with a mutant VKORC1 genotype had a lower risperidone AUC and t1/2 and higher clearance .


The hydroxyrisperidone AUC was lower in individuals with the COMT mutant genotype .


Risperidone increased prolactin levels ( iAUC and iCmax ) , which were higher in women than in men .


The most frequent reactions were somnolence ( 47.1 % ) , headache ( 21.4 % ) , and dizziness ( 17.1 % ) .


Women had neurological effects and headache more frequently than men .


The incidence of headache was associated with polymorphisms in the AGTR1 and NAT2 ; neurological effects were associated with CYP2C19 .


Differences in the pharmacokinetics of risperidone are due to polymorphisms in CYP2D6 , COMT , and VKORC1 .


Differences in adverse reactions can be explained by gender and polymorphisms in CYP2C19 , AGTR1 , and NAT2 .


To investigate the clinical efficacy of X-ray imaging combined with skin stimulation potential-guided percutaneous radiofrequency thermocoagulation of the Gasserian ganglion for treatment of primary trigeminal neuralgia .


This is a prospective , randomized study .


Sixty patients with primary trigeminal neuralgia were randomly assigned to a study group or control group .


In the study group , the patients underwent X-ray imaging combined with skin stimulation potential-guided percutaneous radiofrequency thermocoagulation of the Gasserian ganglion .


The patients in the control group underwent C-arm X-ray-guided puncture through the foramen ovale , and then the puncture needle was microscopically adjusted according to the intensity of the masticatory muscle response and the patients ' reactions .


Puncture success , postoperative adverse reactions , and short - and middle-term analgesic efficacies were statistically compared between the two surgical approaches .


The incidence of postoperative side effects was significantly reduced , and immediate and mid-term analgesic efficacy was better in patients in the study group comparing with those in the control group ( P < 0.01 ) .


Using skin stimulation potential-guided puncture may enable more accurate microscopic adjustment of the targets localization damaged by radiofrequency and significantly enhanced clinical efficacy in this study .


To assess pregabalin monotherapy for partial-onset seizures using a historical-controlled conversion-to-monotherapy design .


Adults with inadequately controlled partial-onset seizures while receiving 1 or 2 antiepileptic drugs during an 8-week prospective baseline were randomized to double-blind monotherapy with pregabalin 600 or 150 mg/d ( 4:1 ) for 20 weeks ( 8-week conversion and 12-week monotherapy period ) .


The primary endpoint was the seizure-related exit rate for pregabalin 600 mg/d , based on discontinuations due to predefined criteria .


Efficacy was declared if the upper limit of the 95 % confidence interval for the exit rate was below a historical-control threshold of 74 % , with stepwise evaluation using a threshold of 68 % .


The trial was stopped early for positive efficacy after an interim analysis in 125 patients .


The full study population included 161 patients , with 148 evaluable for efficacy .


The mean time since epilepsy diagnosis was 14 years .


Overall , 54.3 % ( 600 mg/d ) and 46.9 % ( 150 mg/d ) of patients completed 20 weeks of double-blind treatment .


Seizure-related exit rate in the 600 mg/d group ( 27.5 % ; 95 % confidence interval , 17.8 % -37.2 % ) was significantly below the 74 % and 68 % thresholds ( p < 0.001 for both ) .


Eight patients on 600 mg/d and 2 on 150 mg/d were seizure-free throughout pregabalin monotherapy .


Pregabalin 's overall safety profile was consistent with prior trials .


Pregabalin monotherapy was safe and efficacious for patients with inadequately controlled partial-onset seizures .


This study provides Class III evidence that patients with inadequately controlled partial-onset seizures switched to pregabalin monotherapy have fewer seizure-related exit events compared with historical controls switched to pseudo-placebo monotherapy .


We investigated the method of switching EPO to CERA that does not cause a decrease in the Hb level .


Fifty EPO-treated patients were randomly divided into two groups in which CERA was administered every two weeks ( Q2W ) or every four weeks ( Q4W ) .


After 8 weeks of treatment , the frequency of administration was changed to Q4W in the former .


Follow-up was performed for 24 weeks .


There was no difference in the Hb level between the two groups until 6 weeks .


In the Q2W group , the Hb maintained a stable level throughout a study period .


However , in the Q4W group , the Hb level was significantly lower than in the Q2W group at weeks 9 , 11 , and 13 .


EPO switching to CERA without a decrease in the Hb level could be achieved by administering CERA every two weeks , but not every four weeks , for a specific period after switching .


Cardiovascular disease ( CVD ) and the underlying atherosclerosis begin in childhood , and their presence and intensity are related to known cardiovascular disease risk factors .


Attention to risk factor control in childhood has the potential to reduce subsequent risk of CVD .


The Young Hearts Strong Starts Study was designed to test strategies facilitating adoption of the National , Heart , Lung and Blood Institute supported Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents .


This study compares guideline-based quality measures for body mass index , blood pressure , and tobacco using two strategies : a multifaceted , practice-directed intervention versus standard dissemination .


Two primary care research networks recruited practices and provided support for the intervention and outcome evaluations .


Individual practices were randomly assigned to the intervention or control groups using a cluster randomized design based on network affiliation , number of clinicians per practice , urban versus nonurban location , and practice type .


The units of observation are individual children because measure adherence is abstracted from individual patient 's medical records .


The units of randomization are physician practices .


This results in a multilevel design in which patients are nested within practices .


The intervention practices received toolkits and supported guideline implementation including academic detailing , an ongoing e-learning group .


This project is aligned with the American Board of Pediatrics Maintenance of Certification requirements including monthly physician self-abstraction , webinars , and other elements of the trial .


This trial will provide an opportunity to demonstrate tools and strategies to enhance CV prevention in children by guideline-based interventions .


Checklists may help reduce discharge errors ; however , current paper checklists have limited functionality .


In 2013 a best-practice discharge checklist using the electronic health record ( EHR ) was developed and evaluated at Stanford University Medical Center ( Stanford , California ) in a cluster randomized trial to evaluate its usage , user satisfaction , and impact on physicians ' work flow .


The study was divided into four phases .


In Phase I , on the survey ( N = 76 ) , most of the participants ( 54.0 % ) reported using memory to remember discharge tasks .


On a 0-100 scale , perception of checklists as being useful was strong ( mean , 66.4 ; standard deviation [ SD ] , 21.2 ) , as was interest in EHR checklists ( 64.5 , 26.6 ) .


In Phase II , the checklist consisted of 15 tasks categorized by admission , hospitalization , and discharge-planning .


In Phase III , the checklist was implemented as an EHR `` smart-phrase '' allowing for automatic insertion .


In Phase IV , in a trial with 60 participating physicians , 23 EHR checklist users reported higher usage than 12 paper users ( 28.5 versus 7.67 , p = .019 ) , as well as higher checklist integration with work flow ( 22.6 versus 1.67 , p = .014 ) , usefulness of checklist ( 33.7 versus .


8.92 , p = .041 ) , discharge confidence ( 30.8 versus 5.00 , p = .029 ) , and discharge efficiency ( 25.5 versus 6.67 , p = .056 ) .


Increasing EHR checklist use was correlated with usefulness ( r = .85 , p < .001 ) , confidence ( r = .81 , p < .001 ) , and efficiency ( r = .87 , p < .001 ) .


The EHR checklist reminded physicians to complete discharge tasks , improved confidence , and increased process efficiency .


This is the first study to show that medicine residents use `` memory '' as the most common method for remembering discharge tasks .


These data reinforce the need for a formalized tool , such as a checklist , that residents can rely on to complete important discharge tasks .


Coordination of the tasks of performing chest compressions and defibrillation can lead to communication challenges that may prolong time spent off the chest .


The purpose of this study was to determine whether defibrillation provided by the provider performing chest compressions led to a decrease in peri-shock pauses as compared to defibrillation administered by a second provider , in a simulated cardiac arrest scenario .


This was a randomized , controlled study measuring pauses in chest compressions for defibrillation in a simulated cardiac arrest model .


We approached hospital providers with current CPR certification for participation between July , 2011 and October , 2011 .


Volunteers were randomized to control ( facilitator-administered defibrillation ) or experimental ( compressor-administered defibrillation ) groups .


All participants completed one minute of chest compressions on a mannequin in a shockable rhythm prior to administration of defibrillation .


We measured and compared pauses for defibrillation in both groups .


Out of 200 total participants , we analyzed data from 197 defibrillations .


Compressor-initiated defibrillation resulted in a significantly lower pre-shock hands-off time ( 0.57 s ; 95 % CI : 0.47-0 .67 ) compared to facilitator-initiated defibrillation ( 1.49 s ; 95 % CI : 1.35-1 .64 ) .


Furthermore , compressor-initiated defibrillation resulted in a significantly lower peri-shock hands-off time ( 2.77 s ; 95 % CI : 2.58-2 .95 ) compared to facilitator-initiated defibrillation ( 4.25 s ; 95 % CI : 4.08-4 .43 ) .


Assigning the responsibility for shock delivery to the provider performing compressions encourages continuous compressions throughout the charging period and decreases total time spent off the chest .


However , as this was a simulation-based study , clinical implementation is necessary to further evaluate these potential benefits .


The successful treatment of intraabdominal infection requires a combination of anatomical source control and antibiotics .


The appropriate duration of antimicrobial therapy remains unclear .


We randomly assigned 518 patients with complicated intraabdominal infection and adequate source control to receive antibiotics until 2 days after the resolution of fever , leukocytosis , and ileus , with a maximum of 10 days of therapy ( control group ) , or to receive a fixed course of antibiotics ( experimental group ) for 41 calendar days .


The primary outcome was a composite of surgical-site infection , recurrent intraabdominal infection , or death within 30 days after the index source-control procedure , according to treatment group .


Secondary outcomes included the duration of therapy and rates of subsequent infections .


Surgical-site infection , recurrent intraabdominal infection , or death occurred in 56 of 257 patients in the experimental group ( 21.8 % ) , as compared with 58 of 260 patients in the control group ( 22.3 % ) ( absolute difference , -0.5 percentage point ; 95 % confidence interval [ CI ] , -7.0 to 8.0 ; P = 0.92 ) .


The median duration of antibiotic therapy was 4.0 days ( interquartile range , 4.0 to 5.0 ) in the experimental group , as compared with 8.0 days ( interquartile range , 5.0 to 10.0 ) in the control group ( absolute difference , -4.0 days ; 95 % CI , -4.7 to -3.3 ; P < 0.001 ) .


No significant between-group differences were found in the individual rates of the components of the primary outcome or in other secondary outcomes .


In patients with intraabdominal infections who had undergone an adequate source-control procedure , the outcomes after fixed-duration antibiotic therapy ( approximately 4 days ) were similar to those after a longer course of antibiotics ( approximately 8 days ) that extended until after the resolution of physiological abnormalities .


( Funded by the National Institutes of Health ; STOP-IT ClinicalTrials.gov number , NCT00657566 . )


The genetic polymorphism concerning the 3-subunit of platelet integrin receptor glycoprotein IIIa is held responsible for enhanced binding of adhesive proteins resulting in increased thrombogenic potential .


Whether it is associated with mortality , HbA1c or platelet volume is tested prospectively in an epidemiological cohort .


Population-based Cooperative Health Research in the Region of Augsburg ( KORA ) S4-Survey ( N = 4,028 ) was investigated for prognostic value of PLA1A2-polymorphism regarding all-cause mortality , correlation with HbA1c , and mean platelet volume .


Multivariate analysis was performed to investigate association between genotype and key variables .


Prevalence of thrombogenic allele variant PLA2 was 15.0 % .


Multivariate analysis revealed no association between PLA1A2 polymorphism and mortality in the KORA-cohort .


HbA1c was a prognostic marker of mortality in non-diabetic persons resulting in J-shaped risk curve with dip at HbA1c = 5.5 % ( 37 mmol/mol ) , confirming previous findings regarding aged KORA-S4 participants ( 55-75 years ) .


PLA1A2 was significantly associated with elevated HbA1c levels in diabetic patients ( N = 209 ) and reduced mean platelet volume in general population .


In non-diabetic participants ( N = 3,819 ) , carriers of PLA2 allele variant presenting with HbA1c > 5.5 % ( 37 mmol/mol ) showed higher relative risk of mortality with increasing HbA1c .


PLA1A2 polymorphism is associated with mortality in participants with HbA1c ranging from 5.5 % ( 37 mmol/mol ) to 6.5 % ( 48 mmol/mol ) .


Maintenance of euglycemic control and antiplatelet therapy are therefore regarded as effective primary prevention in this group .


The large placebo effect observed in prior acupuncture trials presents a substantial challenge for interpretation of the efficacy of acupuncture .


We sought to evaluate the relationship between response expectancy , a key component of the placebo effect over time , and treatment outcome in real and sham electroacupuncture ( EA ) .


We analyzed data from a randomized controlled trial of EA and sham acupuncture ( SA ) for joint pain attributable to aromatase inhibitors among women with breast cancer .


Responders were identified using the Patient Global Impression of Change instrument at Week 8 ( end of intervention ) .


The Acupuncture Expectancy Scale ( AES ) was used to measure expectancy four times during the trial .


Linear mixed-effects models were used to evaluate the association between expectancy and treatment response .


In the wait list control group , AES remained unchanged over treatment .


In the SA group , Baseline AES was significantly higher in responders than nonresponders ( 15.5 vs 12.1 , P = .005 ) and AES did not change over time .


In the EA group , Baseline AES scores did not differ between responders and nonresponders ( 14.8 vs 15.3 , P = .64 ) ; however , AES increased in responders compared with nonresponders over time ( P = .004 for responder and time interaction term ) with significant difference at the end of trial for responders versus nonresponders ( 16.2 vs 11.7 , P = .004 ) .


Baseline higher response expectancy predicts treatment response in SA , but not in EA .


Divergent mechanisms may exist for how SA and EA influence pain outcomes , and patients with low expectancy may do better with EA than SA .


We aimed to evaluate the effects of raw red onion consumption on metabolic features in overweight and obese women with polycystic ovary syndrome .


In this randomized controlled clinical trial , the patients ( n = 54 ) were randomly allocated to the intervention group as ` high-onion ' ( raw red onions : 2 40-50 g/day if overweight and 2 50-60 g/day if obese ) or to the control group as ` low-onion ' ( raw red onions : 2 10-15 g/day ) along with limited liliaceous vegetables for 8 weeks .


Body mass index , dietary record , and metabolic parameters ( fasting blood sugar , triglycerides , total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , and lipoprotein ( a ) ) were evaluated in the follicular phase of the menstrual cycle at baseline and after 8 weeks .


Hormonal variables ( progesterone , prolactin , and 17-OH progesterone ) were also measured at baseline .


Onion significantly decreased the levels of total cholesterol within each group ; however , these changes were stronger in the high-onion group ( weighted mean differences [ WMD ] : -5.60 [ 95 % confidence interval [ CI ] : -9.16 , -2.03 ] ; P = 0.003 ) than in the low-onion group ( WMD : -6.42 [ 95 % CI : -11.97 , -0.87 ] ; P = 0.025 ) .


Similarly , low-density lipoprotein cholesterol decreased significantly ( WMD : -5.13 [ 95 % CI : -9.46 , -0.81 ) ; P = 0.022 ) in the high-onion group , and ( WMD : -2.90 [ 95 % CI -5.57 , -0.21 ] ; P = 0.035 ) in the low-onion group after treatment .


The levels of fasting blood sugar , triglycerides , high-density lipoprotein cholesterol and lipoprotein ( a ) did not differ significantly after 8-week onion treatment .


Adjustment for confounders did not make any significant changes in any of the parameters in post-treatment levels .


Raw red onion consumption appears to be effective as a cholesterol-lowering food agent in women with polycystic ovary syndrome .


However , further investigation is warranted .


Elderly patients are at high risk for both ischemic and bleeding events .


Platelet monitoring offers the opportunity to individualized antiplatelet therapy to optimize the therapeutic risk/benefit ratio .


The ANTARCTIC study is designed to demonstrate the superiority of a strategy of platelet function monitoring with dose and drug adjustment in patients initially on prasugrel 5 mg as compared with a more conventional strategy using prasugrel 5 mg without monitoring and without adjustment ( Conventional Treatment Arm ) to reduce the primary end point evaluated 1 year after stent percutaneous coronary intervention in elderly patients presenting with an acute coronary syndrome ( ACS ) .


ANTARCTIC is a multicenter , prospective , open-label study with 2 parallel arms .


A total of 852 elderly patients ( 75 years ) undergoing stent percutaneous coronary intervention for ACS are to be enrolled .


The primary end point is the time to first occurrence of cardiovascular death , myocardial infarction , stroke , definite stent thrombosis , urgent revascularization , and bleeding complications ( Bleeding Academic Research Consortium definition 2 , 3 , or 5 ) .


Platelet function analyses will be performed 14 days after randomization and repeated 14 days later in patients who require a change in treatment .


ANTARCTIC is a nationwide , prospective , open-label study testing a strategy of platelet function monitoring with dose and drug adjustment to reduce ischemic and bleeding complications in elderly ACS patients undergoing coronary stenting .


Vaniprevir ( MK-7009 ) is a hepatitis C virus ( HCV ) non-structural 3/4a protease inhibitor which significantly increases virologic response rates in HCV genotype ( GT ) 1-infected patients when added to peginterferon and ribavirin ( PR ) .


This was a phase II , multicenter , double-blind , randomized , dose-ranging study in Japanese patients with HCV GT1 infection and previous relapse .


Patients received twice daily vaniprevir 100 , 300 , or 600 mg , or placebo plus PR for 4 weeks then PR alone for 2 weeks .


Further treatment with PR was continued up to a maximum of 72 weeks .


The primary endpoint was rapid virologic response ( RVR ; undetectable HCV RNA at treatment week 4 ) .


Ninety patients completed 4 weeks of vaniprevir/placebo plus PR .


Rates of RVR were significantly higher with vaniprevir compared with placebo ( 86 , 95 , and 76 % in the vaniprevir 100 - , 300 - , and 600-mg arms versus 20 % with control ; p < 0.001 for all comparisons ) .


Rates of SVR , an exploratory analysis , in the vaniprevir 100 - , 300 - , 600-mg , and control arms were 95 , 100 , 100 , and 72 % , respectively .


No patient had virologic breakthrough or non-response while receiving vaniprevir .


There were no serious adverse events ( AEs ) or discontinuations due to an AE during vaniprevir treatment .


Diarrhea and nausea were more common with vaniprevir 600 mg than control or lower vaniprevir doses .


The addition of vaniprevir to PR was associated with an increase in RVR and SVR .


Combined with a generally safe and well-tolerated profile , these data supported the further evaluation of vaniprevir in Japanese patients with HCV GT1 infection ( #NCT 00880763 ) .


The aim of this study was to gain further understanding of placebo response in binge eating disorder .


We pooled participant-level data from 10 double-blind , placebo-controlled , randomized trials of medications for binge eating disorder .


The primary outcomes were response ( 75 % reduction in binge eating episodes ) , cessation of binge eating episodes , change in mean weekly binge eating episodes and binge eating episodes per week .


Of 234 participants receiving placebo , 89 ( 38 % ) were responders and 59 ( 26 % ) attained cessation .


Placebo-treated participants significantly reduced their binge eating .


The mean ( SD ) binge eating episodes per week at baseline was 5.2 ( 3.2 ) and at endpoint was 2.2 ( 2.6 ) .


Lower baseline binge eating episode frequency and longer study participation were significantly associated with response and cessation .


Less severe eating pathology at baseline was associated with higher placebo response and cessation rates .


Future clinical trials may want to stipulate that participants exceed a threshold of illness severity , which may lead to better placebo and drug separation .


Although BiPAP has been used as an adjunct to exercise , little is know about its effect on exercise in COPD .


We aimed to evaluate the acute effect of BiPAP delivered with a standard valve ( Vision , Respironics ) , compared to no assist , on exercise capacity in individuals with COPD .


Peak exercise workload ( WLpeak ) , dyspnea ( Borg ) , end-expiratory lung volume ( EELV ) , tidal volume ( VT ) , minute ventilation ( VE ) , O2 uptake ( VO2 ) , and CO2 production ( VCO2 ) were assessed in 10 COPD patients ( FEV1 53 22 % pred ) during three symptom-limited bicycle exercise tests while breathing i ) without a ventilator ( noPS ) , ii ) with a pressure support ( PS ) of 0 cm H2O ( PS0 ; IPAP & EPAP 4 cm H2O ) and iii ) PS of 10 cm H2O ( PS10 ; IPAP 14 & EPAP 4 cm H2O ) on separate days using a randomized crossover design .


WLpeak was significantly lower with PS10 ( 33 16 ) and PS0 ( 30.5 13 ) than noPS ( 43 19 ) ( p < 0.001 ) .


Dyspnea at peak exercise was similar with noPS , PS0 and PS10 ; at isoload it was lower with noPS compared to PS10 and PS0 ( p < 0.01 ) .


VT and VE were highest with PS10 and lowest with noPS both at peak exercise and isoload ( p < 0.001 ) .


EELV was similar at peak exercise with all three conditions .


VO2 and VCO2 were greater with PS10 and PS0 than noPS ( p < 0.001 ) , both at peak exercise and isoload .


Use of BiPAP with a standard exhalation valve during exercise increases VT and VE at the expense of augmenting VCO2 and dyspnea , which in turns reduces WLpeak in COPD patients .


Heart rate characteristics monitoring for early detection of late-onset neonatal sepsis was first described in 2003 .


This technique , which uses mathematical methods to report the fold-increase in the risk of imminent neonatal sepsis , adds independent information to laboratory tests and clinical findings , and , in a large randomized trial , reduced NICU mortality of very low birth weight infants .


Through re-analysis and new secondary analyses of published studies , we have systematically evaluated the utility of this new risk marker for screening the growing population of premature infants .


We followed the guidelines proposed by Hlatky et al. ( Circulation , 119:2408 -2416 , 2009 ) , reviewed past works , and re-analyzed data from 1,489 patients receiving conventional monitoring alone , 348 of whom had 488 episodes of proven sepsis , in the large randomized trial .


Heart rate characteristics monitoring passed all phases of risk marker development from proof of concept to improvement of clinical outcomes .


The predictiveness curve affirmed good calibration , and addition of the heart rate characteristics index to predictive models using standard risk factors favorably impacted the receiver operating characteristic curve area ( increase of 0.030 ) , continuous net reclassification index ( 0.389 ) and the integrated discrimination index ( 0.008 ) , and compares well to other modern risk factors .


Heart rate characteristics monitoring is a validated risk marker for sepsis in the NICU .


Combining a long-acting muscarinic antagonist with a long-acting - agonist has been shown to be pharmacologically useful in patients with chronic obstructive pulmonary disease ( COPD ) .


The aim of the present study was to evaluate the effectiveness of the dual bronchodilator therapy on airway dimensions in COPD .


Patients ( n = 54 ) were randomly assigned to receive tiotropium ( 18g once daily ) , indacaterol ( 150g once daily ) or tiotropium plus indacaterol for 16 weeks .


Quantitative computed tomography ( CT ) , pulmonary function and health status ( St. George 's Respiratory Questionnaire ) were measured .


Compared with tiotropium or indacaterol alone , combination therapy resulted in a significant decrease in percentage wall area ( WA % ) and wall thickness , corrected for body surface area , and an increase in luminal area ( Ai/BSA ) .


Concurrent treatment was superior to monotherapy in physiological indices , including forced vital capacity , forced expiratory volume in 1s ( FEV ) and inspiratory capacity .


The changes in WA % and Ai/BSA were significantly correlated with changes in FEV ( r = -0.44 , P < 0.01 and r = 0.37 , P < 0.01 ) .


There were more significant improvements in SGRQ scores after treatment with combined therapy than with either treatment alone .


Concurrent therapy with tiotropium and indacaterol is effective for COPD patients to promote reduction in airway wall thickness , bronchodilation , and improvements in lung function compared with a single inhaler .


To determine the subjective and objective outcomes of retroperitoneoscopic vs open pyeloplasty with minimal incision in a prospective randomized comparison study .


In this study between August 2011 to July 2013 , 30 patients underwent retroperitoneal laparoscopic pyeloplasty and 30 open pyeloplasty with minimal incision ( incision length < 10 cm ) after randomization .


The 2 groups were compared for the visual pain score on the first and second postoperative days as the primary end point of the study .


Complications were recorded and graded using Dindo-modified Clavien classification of surgical complications .


Success rates were evaluated by improvement in pain score and objectively by diethylene triamine penta-acetic acid renal scan and other parameters .


Statistical analysis was performed with SPSS version 16.0 ( IBM ) with P < .05 considered statistically significant .


The difference in the visual pain score ( 5.6 vs 3.2 on day 1 ; 3.8 vs 1.5 on day 2 ) and the diclofenac requirements ( 333.3 vs 178.75 mg ) were statistically significant and more in the open pyeloplasty .


The hospital stay and convalescence were significantly lower in retroperitoneoscopic group .


Success rate was found to be 96.67 % with 1 failure in each group .


Two patients in retroperitoneoscopic group required conversion .


Both groups showed significant improvement in pain score and drainage pattern on diethylene triamine penta-acetic acid scan with decrease in hydronephrosis on ultrasound evaluation .


Although subjective and objective outcomes are equivalent in both the groups , the retroperitoneoscopic approach is associated with significantly less pain , less analgesic requirement , shorter hospital stay and short convalescence in comparison with open pyeloplasty .


The stimulant prodrug lisdexamfetamine dimesylate ( LDX ) is an effective and generally well tolerated treatment for the symptoms of attention-deficit/hyperactivity disorder ( ADHD ) .


Positive impacts of LDX on health-related quality of life and functional impairment have previously been demonstrated in a 7-week , randomized , double-blind , placebo-controlled , phase III study in children and adolescents in Europe .


Maintenance of these broad benefits , as well as symptomatic control , is a key goal of long-term management of ADHD .


Secondary objectives of this multinational study in children and adolescents with ADHD were to assess the long-term maintenance of effectiveness of LDX in improving health-related quality of life and reducing functional impairment , as gauged using the Child Health and Illness Profile-Child Edition : Parent Report Form ( CHIP-CE : PRF ) and the Weiss Functional Impairment Rating Scale-Parent Report ( WFIRS-P ) , respectively .


Patients aged 6-17 years with diagnosed ADHD and a baseline ADHD Rating Scale IV total score of at least 28 were enrolled from the previous European study and from US sites .


Patients who completed an open-label LDX treatment period of at least 26 weeks were randomized ( 1:1 ) to continue on their optimized dose of LDX or to switch to placebo for a 6-week , double-blind , withdrawal period .


Parents completed CHIP-CE : PRF and WFIRS-P questionnaires at weeks 0 , 8 and 26 of the open-label period and at weeks 0 and 6 of the randomized-withdrawal period , or at early termination .


The endpoint of each period was defined as the last visit with valid data .


Effect sizes were the difference ( LDX minus placebo ) in least-squares ( LS ) - mean change from baseline to endpoint divided by root-mean-square error .


P values were nominal and not adjusted for multiple comparisons .


The open-label and randomized full analysis sets comprised 262 and 153 ( LDX n = 76 ; placebo n = 77 ) patients , respectively .


Mean pretreatment CHIP-CE : PRF T-scores were more than one standard deviation below the normative mean in four of the five domains , and there was significant improvement across all domains from baseline to endpoint of the open-label period .


In the randomized-withdrawal period , LS-mean CHIP-CE : PRF T-scores deteriorated in all domains in the placebo group , but not in the LDX group .


Compared with placebo , the effect of LDX was significant in the Risk Avoidance ( effect size 0.829 ; p < 0.001 ) , Achievement ( 0.696 ; p < 0.001 ) and Satisfaction ( 0.636 ; p < 0.001 ) domains .


Mean pretreatment WFIRS-P scores were lowest in the Family domain and the Learning and School domain .


WFIRS-P total score and scores in all domains improved significantly from baseline to endpoint of the open-label period .


In the randomized-withdrawal period , LS-mean scores deteriorated in the placebo group but not in the LDX group .


Compared with placebo , the effect of LDX was significant in the Family , Learning and School , and Risky Activities domains and in total ( effect size 0.908 ; p < 0.001 ) .


Using parent-rated instruments , long-term maintenance of the beneficial effect of LDX in multiple domains of health-related quality of life and functional impairment was demonstrated by comparison of treatment continuation and withdrawal under randomized , double-blind , placebo-controlled conditions .


The effects of dietary fatty acid supplementation on lipoprotein fatty acid composition have rarely been described .


Sixty-one overweight and obese adults with dyslipidemia and insulin resistance were randomized to placebo , 2g/day extended-release nicotinic acid ( ERN ) , 4g/day prescription omega-3 fatty acid ethyl ester ( P-OM3 ) , or combination therapy for 16 weeks .


Lipoprotein fatty acid composition was analyzed by gas chromatography pre - and post-treatment .


Treatment with P-OM3 or combination , but not ERN , increased proportions of eicosapentaenoic acid , docosahexaenoic acid , and docosapentaenoic acid , and reduced those for arachidonic acid in all lipoprotein fractions , with greatest impact in the high-density lipoprotein fraction .


P-OM3-induced changes in eicosapentaenoic acid within low-density lipoproteins and very low-density lipoproteins were associated with beneficial effects on mean arterial pressure and pulse pressure .


P-OM3 supplementation , with or without ERN , was associated with differentially altered lipoprotein fatty acid composition and improved blood pressure parameters .


To evaluate the pharmacokinetics of oral canagliflozin and its O-glucuronide metabolites ( M7 and M5 ) after single and multiple doses in healthy adult participants .


The pharmacodynamics , safety , and tolerability of canagliflozin were also evaluated .


In this open-label , single - ( day 1 ) and multiple-dose ( days 4-9 ) , parallel-group , phase 1 study , 27 healthy participants were randomized into three groups ( 1:1:1 ) to receive 50 , 100 , or 300 mg canagliflozin .


Pharmacokinetics and pharmacodynamics were assessed at pre-pecified timepoints on days 1 , 9 , and 10 .


Mean area under the plasma concentration-time curve , and the maximum observed plasma concentration of canagliflozin , M7 , and M5 increased in a dose-dependent manner , across all the 3 doses , following single - and multiple-dose administration .


The mean apparent elimination half-lives of canagliflozin , M7 , and M5 were independent of the dose .


Canagliflozin decreased the renal threshold for glucose ( RTG ) and increased the urinary glucose excretion ( UGE ) in a concentration - and dose-dependent manner .


The relationship between drug concentrations and RTG was described by a sigmoidal relationship with RTGmin ( minimum value of RTG ) of 37.5 ng/mL ( 95 % confidence interval ( CI ) : 34.3 , 40.8 ) and half-maximal effective concentration ( EC50 ) of 21 ng/mL ( 95 % CI : 18.3 , 23.8 ) .


No deaths , serious adverse events , hypoglycemic events , or discontinuations due to adverse events were observed .


Pharmacokinetics of canagliflozin and its metabolites ( M7 and M5 ) were linear , and no time-dependent changes were observed after single - and multiple-dose administration .


Similarly , pharmacodynamic effects of canagliflozin on RTG and UGE were found to be dose - and concentration-dependent .


Overall , canagliflozin was well-tolerated in healthy participants .


Neuroendocrine and immune stresses imposed by chronic sleep restriction are known to be involved in the harmful cardiovascular effects associated with poor sleep .


Despite a well-known beneficial effect of napping on alertness , its effects on neuroendocrine stress and immune responses after sleep restriction are largely unknown .


This study was a strictly controlled ( sleep-wake status , light environment , caloric intake ) , crossover , randomized design in continuously polysomnography-monitored subjects .


The study was conducted in a laboratory-based study .


The subjects were 11 healthy young men .


We investigated the effects on neuroendocrine and immune biomarkers of a night of sleep restricted to 2 h followed by a day without naps or with 30 minute morning and afternoon naps , both conditions followed by an ad libitum recovery night starting at 20:00 .


Salivary interleukin-6 and urinary catecholamines were assessed throughout the daytime study periods .


The increase in norepinephrine values seen at the end of the afternoon after the sleep-restricted night was not present when the subjects had the opportunity to take naps .


Interleukin-6 changes observed after sleep deprivation were also normalized after napping .


During the recovery day in the no-nap condition , there were increased levels of afternoon epinephrine and dopamine , which was not the case in the nap condition .


A recovery night after napping was associated with a reduced amount of slow-wave sleep compared to after the no-nap condition .


Our data suggest that napping has stress-releasing and immune effects .


Napping could be easily applied in real settings as a countermeasure to the detrimental health consequences of sleep debt .


Prior research has indicated that the loss of skeletal muscle mass and bone mineral density observed with aging is related to the prominent age-related decline in the concentration of serum growth hormone ( GH ) .


However , there is limited data on the effects of aging on GH responses to acute bouts of heavy resistance exercise ( HRE ) and aerobic exercise ( AE ) .


The present investigation examined the effects of a HRE protocol and an AE protocol on immunoreactive GH ( IGH ) and bioactive GH ( BGH ) in active young and old women .


Older women had a diminished serum IGH response to both the HRE and AE protocols compared to the younger women , however a similar response was not observed in serum BGH .


Additionally , the HRE protocol elicited a greater BGH response than the AE protocol exclusively in the younger group .


Regardless of exercise mode , aging induces an increase in growth hormone polymerization that specifically results in a loss of serum growth hormone immunoreactivity without a concurrent loss of serum growth hormone bioactivity .


The greater BGH response to the HRE protocol found in the younger group can be attributed to an unknown serum factor of molecular weight between 30 and 55kD that either potentiated growth hormone bioactivity in response to HRE or inhibited growth hormone bioactivity in response to AE .


Behavioral measures are often used to distinguish subgroups of patients with stroke ( eg , to predict treatment gains , stratify clinical trial enrollees , or select rehabilitation therapy ) .


In studies of the upper extremity , measures of brain function using functional magnetic resonance imaging ( fMRI ) have also been found useful , but this approach has not been examined for the lower extremity .


The current study hypothesized that an fMRI-based measure of cortical function would significantly improve prediction of treatment-induced lower extremity behavioral gains .


Biomarkers of treatment gains were also explored .


Patients with hemiparesis 1 to 12 months after stroke were enrolled in a double-blind , placebo-controlled , randomized clinical trial of ropinirole + physical therapy versus placebo + physical therapy , results of which have previously been reported ( NCT00221390 ) .


( 15 ) Primary end point was change in gait velocity .


Enrollees underwent baseline multimodal assessment that included 19 measures spanning 5 assessment categories ( medical history , impairment , disability , brain injury , and brain function ) , and also underwent reassessment 3 weeks after end of therapy .


In bivariate analysis , 8 baseline measures belonging to 4 categories ( medical history , impairment , disability , and brain function ) significantly predicted change in gait velocity .


Prediction was strongest , however , using a multivariate model containing 2 measures ( leg Fugl-Meyer score and fMRI activation volume within ipsilesional foot sensorimotor cortex ) .


Increased activation volume within bilateral foot primary sensorimotor cortex correlated positively with treatment-induced leg motor gains .


A multimodal model incorporating behavioral and fMRI measures best predicted treatment-induced changes in gait velocity in a clinical trial setting .


Results also suggest potential use of fMRI measures as biomarkers of treatment gains .


To investigate the effect of overnight orthokeratology ( OK ) contact lens wear on axial length growth in East Asian children with progressive myopia .


A prospective , randomized , contralateral-eye crossover study conducted over a 1-year period .


We enrolled 26 myopic children ( age range , 10.8-17 .0 years ) of East Asian ethnicity .


Subjects were fitted with overnight OK in 1 eye , chosen at random , and conventional rigid gas-permeable ( GP ) lenses for daytime wear in the contralateral eye .


Lenses were worn for 6 months .


After a 2-week recovery period without lens wear , lens-eye combinations were reversed and lens wear was continued for a further 6 months , followed by another 2-week recovery period without lens wear .


Axial eye length was monitored at baseline and every 3 months using an IOLMaster biometer .


Corneal topography ( Medmont E300 ) and objective refraction ( Shin-Nippon NVision-K 5001 autorefractor ) were also measured to confirm that OK lens wear was efficacious in correcting myopia .


Axial length elongation and myopia progression with OK were compared with conventional daytime rigid contact lens wear .


After 6 months of lens wear , axial length had increased by 0.040.06 mm ( meanstandard deviation ) in the GP eye ( P = 0.011 ) but showed no change ( -0.020.05 mm ) in the OK eye ( P = 0.888 ) .


During the second 6-month phase of lens wear , in the OK eye there was no change from baseline in axial length at 12 months ( -0.040.08 mm ; P = 0.218 ) .


However , in the GP eye , the 12-month increase in axial length was significant ( 0.090.09 mm ; P < 0.001 ) .


The GP lens-wearing eye showed progressive axial length growth throughout the study .


These results provide evidence that , at least in the initial months of lens wear , overnight OK inhibits axial eye growth and myopia progression compared with conventional GP lenses .


Apparent shortening of axial length early in OK lens wear may reflect the contribution of OK-induced central corneal thinning , combined with choroidal thickening or recovery due to a reduction or neutralization of the myopiogenic stimulus to eye growth in these myopic children .


Obsessive-compulsive disorder ( OCD ) is a very disabling condition with a chronic course , if left untreated .


Though cognitive behavioral treatment ( CBT ) with or without selective serotonin reuptake inhibitors ( SSRI ) is the method of choice , up to one third of individuals with obsessive-compulsive disorder ( OCD ) do not respond to treatment in terms of at least 35 % improvement of symptoms .


Mindfulness based cognitive therapy ( MBCT ) is an 8-week group program that could help OCD patients with no or only partial response to CBT to reduce OC symptoms and develop a helpful attitude towards obsessions and compulsive urges .


This study is a prospective , bicentric , assessor-blinded , randomized , actively-controlled clinical trial .