One hundred and six BPH patients were randomly assigned to the treatment group ( 53 cases ) and the control group ( 53 cases ) according to a random number table .


The treatment group was given KQR orally ; the control group was given cernilton orally .


After 24-week treatment , the clinical effect and safety were evaluated using the International Prostatic Symptom Score ( I-PSS ) , quality of life ( QOL ) , maximum flow rate ( Qmax ) , average flow rate ( Qave ) , residual urine volume ( RUV ) , total prostatic volume ( TPV ) , etc. .


After treatment , the score of I-PSS was decreased from 16.95.6 to 12.54.6 in the treatment group , significantly lower compared with the control group ; the levels of Qmax and Qave were from 10.93.5 to 15.64.5 and 5.42.1 to 7.32.5 ( mL/s ) in the treatment group , significantly higher compared with the control group ; the levels of RUV and TPV were from 70.828.2 to 35.221.8 and 37.216.9 to 30.110.8 ( mL ) in the treatment group , significantly lower compared with the control group ( all P < 0.05 ) .


The incidence rate of adverse reaction was similar between the two groups ( P > 0.05 ) .


KQR is effective and safe for the treatment of BPH .


Overweight or obesity is prevalent among college students and many gain weight during this time .


Traditional face-to-face weight loss interventions have not worked well in this population .


Facebook is an attractive tool for delivering weight loss interventions for college students because of its popularity , potential to deliver strategies found in successful weight loss interventions , and ability to support ongoing adaptation of intervention content .


The objective of this study was to describe participant exposure to a Facebook page designed to deliver content to overweight/obese college students in a weight loss randomized controlled trial ( N = 404 ) and examine participant engagement with behavior change campaigns for weight loss delivered via Facebook .


The basis of the intervention campaign model were 5 self-regulatory techniques : intention formation , action planning , feedback , goal review , and self-monitoring .


Participants were encouraged to engage their existing social network to meet their weight loss goals .


A health coach moderated the page and modified content based on usage patterns and user feedback .


Quantitative analyses were conducted at the Facebook post - and participant-level of analysis .


Participant engagement was quantified by Facebook post type ( eg , status update ) and interaction ( eg , like ) and stratified by weight loss campaign ( sequenced vs nonsequenced ) .


A subset of participants were interviewed to evaluate the presence of passive online engagement or `` lurking . ''


The health coach posted 1816 unique messages to the study 's Facebook page over 21 months , averaging 3.45 posts per day ( SD 1.96 , range 1-13 ) .


In all , 72.96 % ( 1325/1816 ) of the posts were interacted with at least once ( eg , liked ) .


Of these , approximately 24.75 % ( 328/1325 ) had 1-2 interactions , 23.39 % ( 310/1325 ) had 3-5 interactions , 25.13 % ( 333/1325 ) had 6-8 interactions , and 41 posts had 20 or more interactions ( 3.09 % , 41/1325 ) .


There was significant variability among quantifiable ( ie , visible ) engagement .


Of 199 participants in the final intervention sample , 32 ( 16.1 % ) were highly active users and 62 ( 31.2 % ) never visibly engaged with the intervention on Facebook .


Polls were the most popular type of post followed by photos , with 97.5 % ( 79/81 ) and 80.3 % ( 386/481 ) interacted with at least once .


Participants visibly engaged less with posts over time ( partial r = -.33 ; P < .001 ) .


Approximately 40 % of the participants interviewed ( 12/29 , 41 % ) reported passively engaging with the Facebook posts by reading but not visibly interacting with them .


Facebook can be used to remotely deliver weight loss intervention content to college students with the help of a health coach who can iteratively tailor content and interact with participants .


However , visible engagement with the study 's Facebook page was highly variable and declined over time .


Whether the level of observed engagement is meaningful in terms of influencing changes in weight behaviors and outcomes will be evaluated at the completion of the overall study .


Recent research suggests that safety behaviors ( SB ) may not preclude treatment gains in exposure-based therapy for obsessive-compulsive disorder .


However , it is relatively unknown what specific types of SBs may be detrimental to the therapeutic process , with some arguing that SBs be classified based on their function .


The current study sought to examine the extent to which different SBs enhanced or weakened symptoms of contamination fear during a single session of exposure .


Sixty-seven non-clinical students were randomly assigned to one of three conditions : ( 1 ) exposure with no SBs ( NSB ) , ( 2 ) exposure with preventive SBs ( PSB ) , or ( 3 ) exposure with restorative SBs ( RSB ) .


Among the primary outcome measures , greater reductions in fear and behavioral avoidance were found for RSB in comparison to PSB , and the gains made by RSB were generalizable to other sources of potential contamination .


Furthermore , RSB resulted in more rapid reductions in fear and disgust across repeated exposure trials .


Limitations include the use of a nonclinical student sample .


Overall , the current study suggests that RSB may be beneficial as an adjunct to therapy whereas PSB are potentially detrimental .


Results of the study are discussed in terms of exposure theories and the treatment of anxiety disorders .


To compare the effects of two 9-month parent-implemented interventions within the Early Social Interaction ( ESI ) Project .


Both individual-ESI , offered 2 or 3 times per week at home or in the community , and group-ESI , offered once per week in a clinic , taught parents how to embed strategies to support social communication throughout everyday activities .


Participants in the randomized controlled trial included 82 children diagnosed with autism spectrum disorder at 16 to 20 months .


Children were matched on pretreatment nonverbal developmental level and pairs were randomly assigned to treatment condition .


Child outcomes included measures of social communication , autism symptoms , adaptive behavior , and developmental level .


Child outcomes are reported from baseline to the end of the 9-month interventions .


Children in individual-ESI showed differential change on a standardized examiner-administered observational measure of social communication , as they improved at a faster rate than children in group-ESI .


Individual-ESI also showed differential efficacy on a parent report measure of communication , daily living , and social skills , as they showed improvement or stability , whereas group-ESI led to worsening or no significant change on these skills .


Finally , individual-ESI showed differential change on examiner-administered measures of receptive language skills , as children in individual-ESI improved significantly , whereas group-ESI showed no change .


These findings support the efficacy of individual-ESI compared with group-ESI on child outcomes , suggesting the importance of individualized parent coaching in natural environments .


The efficacy of a parent-implemented intervention using little professional time has potential for community viability , which is particularly important in light of the lack of main effects on child outcomes of most other parent-implemented interventions .


Japanese cedar ( JC ) pollinosis is the most common seasonal allergic rhinitis in Japan .


Standardized JC pollen extract is available for subcutaneous immunotherapy , but this treatment is limited by potentially serious side effects .


The aim of this double-blind , randomized comparative study was to evaluate the efficacy and safety of standardized JC pollen extract in a new oral formulation ( CEDARTOLEN , Torii Pharmaceutical Co. , Ltd. , Tokyo , Japan ) for sublingual immunotherapy ( SLIT ) for JC pollinosis .


A total of 531 subjects with JC pollinosis were randomized into 2 groups at a ratio of 1:1 to receive daily sublingual administration of standardized JC pollen extract with a maintenance dose of 2,000 Japanese allergy units ( JAU ) or placebo for 2 consecutive pollen seasons .


The efficacy was evaluated using the total nasal symptom and medication score ( TNSMS ) as the primary end point .


Secondary end points included the total ocular symptom and medication score ( TOSMS ) and scores for individual symptoms and medication .


The TNSMS was significantly lower ( p < 0.0001 ) in the SLIT group than in the placebo group in the peak symptom period by 18 and 30 % in the first and second seasons , respectively .


All secondary end points were also significantly lower in the SLIT group in both seasons .


No systemic anaphylaxis occurred .


SLIT with daily administration of standardized JC pollen extract was effective for improving nasal and ocular symptoms of JC pollinosis and reducing the use of relief medication .


The JC pollen extract was well tolerated with only local adverse events .


To investigate the treatment outcome of discontinuing 1 medication from 2-year combination therapy for male benign prostatic hyperplasia/lower urinary tract symptoms .


Patients with International Prostate Symptom Score 8 , total prostatic volume ( TPV ) > 30 mL , and maximum flow rate ( Qmax ) < 15 mL/s were randomly assigned to the 5-reductase inhibitor ( 5ARI ) discontinue ( DC-5ARI ) or - blocker discontinue ( DC -- blocker ) group .


All patients received combination therapy with dutasteride ( 0.5 mg QD ) and doxazosin ( 4 mg QD ) for 2 years and then discontinued either one drug for 12 months .


The primary endpoint was the occurrence of resuming medication .


The secondary endpoints were the net parameters changed or the need of transurethral resection of the prostate ( TURP ) .


A total of 117 patients in DC-5ARI and 113 in DC -- blocker group completed the study .


The baseline TPV and Qmax were similar between groups before combination therapy .


Resumption of combination therapy was significantly more in DC-5ARI than DC -- blocker group ( 51.3 % vs 31.0 % ; P = .005 ) .


The mean duration from discontinuing to resuming medication was 5.0 4.4 months in DC -- blocker and 7.8 3.8 months in DC-5ARI group ( P < .05 ) .


The TPV progression ( 29.1 % vs 8.0 % ; P < .001 ) and the need for TURP ( 14.5 % vs 7.1 % ; P = .043 ) were significantly higher in DC-5ARI than DC -- blocker group .


Patients with larger TPV ( 45.8 18.1 mL ) had significantly greater need for resuming 5ARI than smaller TPV ( 36.3 16.9 mL ; P = .007 ) , and a lower Qmax might predict resuming - blocker .


After a 2-year combination therapy , discontinuation of either one drug induced benign prostatic hyperplasia progression in either group .


Greater risk of resuming medication and needing TURP were noted in patients who discontinued 5ARI .


A combined heart rate ( HR ) and motion sensor ( Actiheart ) has been proposed as an accurate method for assessing total energy expenditure ( TEE ) and physical activity energy expenditure ( PAEE ) .


However , the extent to which factors such as caffeine may affect the accuracy by which the estimated HR-related PAEE contribution will affect TEE and PAEE estimates is unknown .


Therefore , we examined the validity of Actiheart in estimating TEE and PAEE in free-living adults under a caffeine trial compared with doubly labeled water ( DLW ) as reference criterion .


Using a double-blind crossover trial ( Clinicaltrials.gov ID : #NCT 01477294 ) with two conditions ( 4-day each with a 3-day-washout period ) , randomly ordered as caffeine ( 5 mg/kg per day ) and placebo ( malt-dextrine ) intake , TEE was measured by DLW in 17 physically active men ( 20-38 years ) who were non-caffeine users .


In each condition , resting energy expenditure ( REE ) was assessed by indirect calorimetry and PAEE was calculated as ( TEE - ( REE +0.1 TEE ) ) .


Simultaneously , PAEE and TEE were estimated by Actiheart using an individual calibration ( ACC+HR step ) .


Under caffeine , ACC+HR step explained 76 and 64 % of TEE and PAEE from DLW , respectively ; corresponding results for the placebo condition were 82 and 66 % .


No mean bias was found between ACC+HR step and DLW for TEE ( caffeine : -468 kJ per day ; placebo : -407 kJ per day ) , although PAEE was slightly underestimated ( caffeine : -856 kJ per day ; placebo : -1147 kJ per day ) .


Similar limits of agreement were observed in both conditions ranging from -2066 to 3002 and from -3488 to 1776 kJ per day for TEE and PAEE , respectively .


Regardless of caffeine intake , the combined HR and motion sensor is valid for estimating free-living energy expenditure in a group of healthy men but is less accurate for an individual assessment .


The purpose of the study was to assess the impact of dutasteride plus tamsulosin combination therapy , compared with dutasteride or tamsulosin monotherapy , on nocturia in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( LUTS/BPH ) using data from the 4-year CombAT study .


Nocturia was assessed using Question 7 of the International Prostate Symptom Score questionnaire .


Efficacy measures included as follows : mean change in nocturia at 3-month intervals up to 48 months ; proportion of patients with improvement/worsening in nocturia ; nocturnal voiding frequency at baseline and study end , overall and by baseline subgroups ; and nocturnal voiding frequency < 2 at study end in patients with a baseline score 2 .


In total , 4,722 patients with a mean age of 66 years were included .


Mean nocturia improvements were significantly superior ( p 0.01 ) with combination therapy than with either monotherapy ( adjusted mean change from baseline in IPSS Question 7 score at month 48 : combination therapy -0.5 , dutasteride -0.4 , tamsulosin -0.3 ) .


Reduction in nocturia score with combination therapy was significantly ( p 0.01 ) better than tamsulosin monotherapy across all baseline subgroups tested , except for men with previous 5ARI use .


Among those with a baseline IPSS Q7 score 2 , more patients with combination therapy had a score < 2 at month 48 ( 34 % ) compared with dutasteride ( 30 % , p = 0.018 ) or tamsulosin ( 26 % , p < 0.0001 ) .


Combination therapy provided greater improvements and less worsening of nocturia compared with both dutasteride and tamsulosin monotherapies .


These analyses are the first to show greater improvement with a 5ARI / - blocker combination versus either agent alone for the management of nocturia in patients with LUTS/BPH .


Acute stress can increase fatigability and decrease steadiness of sustained low-force contractions that are required for functional tasks in upper limb muscles .


Whether motor performance is more impaired in people with a chronic stress disorder is not known .


This study compared the fatigability and steadiness ( force fluctuations ) of handgrip muscles in veterans with posttraumatic stress disorder ( PTSD ) and civilian controls in the presence and absence of varying levels of cognitive demand .


Eighteen veterans with PTSD and 21 healthy controls ( 33 9 yr ) attended three randomized experimental sessions to perform an isometric fatiguing contraction ( 20 % of maximal strength ) with the handgrip muscles .


Two sessions involved performing a cognitive task during the fatiguing contraction : 1 ) difficult mental math task ( stressor ) and 2 ) a simple mental math task ( mental attentiveness ) .


A third session involved a fatiguing contraction with no mental task ( control ) .


Stress elevated heart rate , blood pressure , and levels of anxiety in veterans with PTSD ( P < 0.05 ) but blunted cortisol levels ( P < 0.05 ) .


Time to failure was briefer ( 7.2 2.5 vs 9.3 5.2 min , P = 0.03 ) , and force fluctuations increased at a greater rate for veterans with PTSD than for controls ( P < 0.05 ) .


Cognitive stress did not influence time to failure or force fluctuations for either group ( P > 0.05 ) .


Veterans with PTSD demonstrated greater fatigability and loss of steadiness ( greater force fluctuations ) of the handgrip muscles compared with healthy controls .


Male veterans with PTSD demonstrated altered neuromuscular function of arm muscles that potentially affects functional tasks during daily , ergonomic , and military activities .


For patients with diabetes and triple-vessel disease , coronary artery bypass grafting ( CABG ) surgery is a well-established procedure , but cardiopulmonary bypass support may also lead to severe complications to these patients .


The aim of this study was to compare myocardial protection and early outcomes in patients with diabetes and triple-vessel disease following different coronary surgical techniques .


Prospective randomized trial of patients treated at the First Affiliated Hospital of China Medical University over a 3-year period ( 2011 - 2013 ) .


In a single-center randomized trial , 668 patients with diabetes and triple-vessel disease were randomly assigned to off-pump ( OPCAB ) ( number [ n ] = 222 ) , on-pump beating heart ( OnP-BH ) ( n = 223 ) , and conventional CABG ( OnP ) ( n = 223 ) between January 2011 and October 2013 .


Myocardial injury was assessed by measuring the serial release of cardiac troponin I ( cTnI ) preoperatively , 1 hour , 12 hours , 24 hours , and 72 hours postoperatively .


The early outcomes were compared among these 3 groups .


Preoperative characteristics of the patients in all 3 groups were similar .


No significant difference was found regarding the number of anastomoses , the use of the internal thoracic artery , postoperative new-onset atrial fibrillation , hemodialysis , stroke , reoperation for bleeding , and infective complications in the 3 groups ( P > .05 ) .


The complete revascularization , postoperative drainage loss , intra-aortic balloon pump support , blood requirements , postoperative myocardial infarction , pulmonary complications , gastrointestinal complications , inotropic requirements > 24 hours , ventilation > 24 hours , intensive care unit stay > 24 hours , and in-hospital stay > 7 days were significantly lower in the OPCAB group than in the other 2 groups ( P < .05 ) .


In-hospital mortality was lower in the OPCAB group than in the other 2 groups , but no statistical difference was observed ( P > .05 ) .


Preoperative cTnI in the 3 groups was similar ( P > .05 ) ; however , the lowest cTnI value was noted in the OPCAB group , followed by the OnP group , and it was highest in the OnP-BH group 1 hour , 12 hours , 24 hours , and 72 hours postoperatively ( P < .05 ) .


OPCAB is superior to the OnP-BH and OnP techniques in terms of postoperative complications and myocardial protection in patients with diabetes and triple-vessel disease .


Myocardial injury in the OnP-BH group was significantly higher than that in the OnP group .


This study aims to investigate and evaluate the efficacy and safety of early enteral nutrition ( EN ) in maintaining and improving the postoperative nutritional status in patients undergoing esophagectomy .


A randomized , controlled clinical trial was conducted in 120 adult patients with esophageal cancer and undergoing esophagectomy .


Patients were randomly divided into two groups receiving either EN ( N. = 64 ) or parenteral nutrition ( PN ) ( N. = 56 ) postoperatively .


The nutritional intake was isonitrogenic and isocalorie for both groups .


Nutritional status was evaluated preoperatively as well as on postoperative day I and day 8 .


Daily nitrogen balance was measured and 7-day cumulative nitrogen balance was calculated .


The levels of serum markers including d-lactate , diamine oxidase ( DAO ) , and endotoxin were determined on 1st , 4th and 8th postoperative day for analyzing intestinal barrier function .


Postoperative infection rate and the incidence of nutrition support-related complications were examined .


The concentrations of serum albumin and prealbumin in patients of EN group were significantly higher than those in PN group and the concentrations of blood glucose , - GT , AKP , TB , and DB were significantly lower compared to those in the PN group ( P < 0.05 ) .


Both daily nitrogen balance and cumulative nitrogen balance of EN group were better than those of PN group since postoperative day III .


The serum levels of d-lactate , DAO , and endotoxin of EN group were significantly lower than those of PN group on postoperative day VIII ( P < 0.01 ) .


The incidence of postoperative infections in blood , lung , and intestinal tract in EN group was lower compared to PN group ( P < 0.05 ) .


No severe complications associated with nutritional support occurred in EN group .


The time to flatus passage in EN group was significantly shorter , and the cost of nutritional support was significantly less compared to PN group ( P < 0.05 ) .


Postoperative early enteral nutrition was safe and feasible for patients undergoing esophagectomy .


Compared to PN , EN more efficiently ameliorated postoperational nutritional status of the patients undergoing esophagectomy , played an important role in restoring intestinal barrier function postoperatively , reduced the incidence of postoperative infection , and decreased the cost of hospital stay .


Intravenous N-methyl-d-aspartate ( NMDA ) antagonists have shown promising results in rapidly ameliorating depression symptoms , but placebo-controlled trials of oral NMDA antagonists as monotherapy have not observed efficacy .


We conducted a randomized , double-blind , placebo-controlled trial of the NMDA antagonist memantine as an augmentation treatment for patients with DSM-IV major depressive disorder .


Adult outpatients with major depressive disorder and partial response or nonresponse to their current antidepressant ( as indicated by a 17-item Hamilton Depression Rating Scale score of 16 at baseline ) were randomized ( from July 2006-December 2011 ) to add memantine ( flexible dose 5-20 mg/d , with all memantine group participants reaching the dose of 20 mg/d ) ( n = 15 ) or placebo ( n = 16 ) to their existing treatment for 8 weeks .


The primary outcome , change in Montgomery-Asberg Depression Rating Score ( MADRS ) , was evaluated with repeated-measures mixed effects models using last-observation-carried-forward methods .


Secondary outcomes included other depression and anxiety rating scales , suicidal and delusional ideation , and other adverse effects .


84 % of participants completed the trial , including 93 % of participants receiving memantine .


Participants receiving memantine did not show a statistically or clinically significant change in MADRS scores compared to placebo , either over the entire study ( = 0.133 , favoring placebo , P = .74 ) or at study completion ( week 8 mean [ SD ] MADRS score change = -7.13 [ 6.61 ] [ memantine ] ; -7.25 [ 11.14 ] [ placebo ] ; P = .97 ) .


A minimal to small effect size ( comparing change to baseline variability ) favoring placebo was observed ( Cohen d = 0.19 ) .


Similarly , no substantial effect sizes favoring memantine nor statistically significant between-group differences were observed on secondary efficacy outcomes .


This trial did not detect significant statistical or effect size differences between memantine and placebo augmentation among nonresponders or poor responders to conventional antidepressants .


While the small number of participants is a limitation , this study suggests memantine lacks substantial efficacy as an augmentation treatment for major depressive disorder .


ClinicalTrials.gov identifier : NCT00344682 .


Evidence supports the role of feedback in reinforcing motivation for behavior change .


Feedback that provides reinforcement has the potential to increase dietary self-monitoring and enhance attainment of recommended dietary intake .


The aim of this study was to examine the impact of daily feedback ( DFB ) messages , delivered remotely , on changes in dietary intake .


This was a secondary analysis of the Self - Monitoring And Recording using Technology ( SMART ) Trial , a single-center , 24-month randomized clinical trial of behavioral treatment for weight loss .


Participants included 210 obese adults ( mean body mass index , 34.0 kg/m ) who were randomized to either a paper diary ( PD ) , personal digital assistant ( PDA ) , or PDA plus daily tailored feedback messages ( PDA + FB ) .


To determine the role of daily tailored feedback in dietary intake , we compared the self-monitoring with DFB group ( DFB group ; n = 70 ) with the self-monitoring without DFB group ( no-DFB group , n = 140 ) .


All participants received a standard behavioral intervention for weight loss .


Self-reported changes in dietary intake were compared between the DFB and no-DFB groups and were measured at baseline and at 6 , 12 , 18 , and 24 months .


Linear mixed modeling was used to examine percentage changes in dietary intake from baseline .


Compared with the no-DFB group , the DFB group achieved a larger reduction in energy ( -22.8 % vs -14.0 % ; P = .02 ) and saturated fat ( -11.3 % vs -0.5 % ; P = .03 ) intake and a trend toward a greater decrease in total fat intake ( -10.4 % vs -4.7 % ; P = .09 ) .


There were significant improvements over time in carbohydrate intake and total fat intake for both groups ( P values < .05 ) .


Daily tailored feedback messages designed to target energy and fat intake and delivered remotely in real time using mobile devices may play an important role in the reduction of energy and fat intake .


To investigate the accelerating effects of low-intensity pulse ultrasound stimulation ( LIPUS ) on the fracture healing of distal radius .


A total of 81 patients with distal radius fracture were randomly divided into two groups : the ultrasound treatment group and the control group .


Patients in the ultrasound treatment group were immobilized in a below-elbow cast and received LIPUS treatment 15 min/day , while the control group were immobilized by a plaster support and cast .


The patients were followed up every week and took X-ray films .


The initial and healed X-ray films and the gray value of fracture site were analyzed by Photoshop software .


The effect of reposition was evaluated based upon Steward recommended by Dienst , combining with Aro 's measuring method .


Clinical fracture healing time in ultrasound group was significantly shorter than that in the control group ( 32.04 2.58 d vs. 40.75 5.12 d , p < 0.01 ) .


In addition , the grey value changes of fracture sites of the ultrasound group were much higher than that of the control group .


The reposition effects of fracture healing had no difference between the two groups ( p > 0.05 ) .


Low-intensity pulse ultrasound stimulation could accelerate fracture healing of the distal radius and promote local bone formation .


To determine whether clinical findings-bleeding on probing , pocket depth , recession , and bacterial sampling-correlate with histologic outcomes in relatively healthy peri-implant soft tissues in people .


In this cross-sectional study , a convenience sample of 20 edentulous subjects received two endosseous mandibular implants each .


The abutments were either zirconia ( ZrO ) or titanium ( Ti ) ( nonsubmerged implant placement , within-subject comparison , leftright randomization ) .


Sulcular bacterial sampling and assessment of probing pocket depth , recession , and bleeding on probing were performed 3 months postsurgery .


Mucosal biopsy specimens were obtained , and the blood vessel density and a score on an inflammation grading scale were determined .


Simple linear and linear regression models revealed that the clinical or microbiologic parameters were not associated with either of the histologic parameters .


The soft tissues impressed as healthy , regardless of the abutment material .


The peri-implant mucosa around ZrOand Ti abutments was considered healthy in most situations when examined histologically after 3 months but showed variation in clinical and microbiologic parameters .


Exercise prescription in cardiac patients is based on heart rate ( HR ) response to exercise .


How to prescribe long-term exercise training outside medically-supervised settings also considering changes in individual physical capacity over time is unknown .


In this study we hypothesized that in patients with chronic heart failure ( CHF ) the session-rate of perceived exertion ( RPE ) , a subjective-based training methodology , provides autonomic and functional capacity changes superimposable to those observed with HR-based Training Impulses ( TRIMPi ) method .


Twenty patients with stable CHF were randomized to either aerobic continuous training ( ACT ) or aerobic interval training ( AIT ) for 12 weeks .


For each TRIMPi-guided exercise session , the session-RPE was recorded .


By this method , internal training load ( TL ) is quantified by multiplying the RPE of the whole training session , using the Borg CR10-scale , by its duration .


Heart rate variability ( HRV ) , and baroreflex sensitivity ( BRS ) were assessed at baseline and at 3 weeks intervals .


Significant correlations were found between TRIMPi and individual session-RPE , for both ACT and AIT ( r = 0.63 to 0.81 ) , ( P < 0.05 ) .


The same occurred when ACT and AIT groups were pooled together ( r = 0.72 ; P < 0.01 ) .


R-R interval , HRV and BRS were significantly and very highly correlated with weekly RPE-session ( r ( 2 ) ranged from 0.77 to 0.97 ; P < 0.001 ) .


A significant relationship between session-RPE and performance at the 6MWT was also found .


Session-RPE is an easy-to-use , inexpensive and valid method for exercise prescription and health maintenance , consistent with objective physiological indices of training , that could be used for long-term physical activity in patients with CHF .


Epidemiologic data suggest inverse associations between citrus flavanone intake and cardiovascular disease ( CVD ) risk .


However , insufficient randomized controlled trial data limit our understanding of the mechanisms by which flavanones and their metabolites potentially reduce cardiovascular risk factors .


We examined the effects of orange juice or a dose-matched hesperidin supplement on plasma concentrations of established and novel flavanone metabolites and their effects on cardiovascular risk biomarkers in men at moderate CVD risk .


In an acute , randomized , placebo-controlled crossover trial , 16 fasted participants ( aged 51-69 y ) received orange juice or a hesperidin supplement ( both providing 320 mg hesperidin ) or control ( all matched for sugar and vitamin C content ) .


At baseline and 5 h postintake , endothelial function ( primary outcome ) , blood pressure , arterial stiffness , cardiac autonomic function , platelet activation , and NADPH oxidase gene expression and plasma flavanone metabolites were assessed .


Before each intervention , a diet low in flavonoids , nitrate/nitrite , alcohol , and caffeine was followed , and a standardized low-flavonoid evening meal was consumed .


Orange juice intake significantly elevated mean SEM plasma concentrations of 8 flavanone ( 1.75 0.35 mol/L , P < 0.0001 ) and 15 phenolic ( 13.27 2.22 mol/L , P < 0.0001 ) metabolites compared with control at 5 h postconsumption .


Despite increased plasma flavanone and phenolic metabolite concentrations , cardiovascular risk biomarkers were unaltered .


After hesperidin supplement intake , flavanone metabolites were not different from the control , suggesting altered absorption/metabolism compared with the orange juice matrix .


After single-dose flavanone intake within orange juice , circulating flavanone and phenolic metabolites collectively reached a concentration of 15.20 2.15 mol/L , but no effects were observed on cardiovascular risk biomarkers .


Longer-duration randomized controlled trials are required to examine previous associations between higher flavanone intakes and improved cardiovascular health and to ascertain the relative importance of food matrix and flavanone-derived phenolic metabolites .


This trial was registered at clinicaltrials.gov as NCT01530893 .


Incomplete revascularization ( ICR ) after percutaneous coronary intervention ( PCI ) is common and is associated with increased rates of rehospitalization , revascularization , and mortality .


Adjunctive pharmacotherapy with ranolazine , an inhibitor of the late sodium current with anti-ischemic properties , may be effective in reducing recurrent events after PCI in patients with ICR .


RIVER-PCI is a phase 3 , randomized , double-blind , placebo-controlled , international event-driven clinical trial evaluating the efficacy of ranolazine in patients with a history of chronic angina and ICR after PCI .


Approximately 2,600 participants with ICR post-PCI will be randomized in a 1:1 ratio to ranolazine or matched placebo within 14 days of an index PCI .


The primary end point of the trial is time to the first occurrence of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization .


Participants will be followed up for a minimum of 1 year and until at least 720 confirmed primary end point events have occurred .


Secondary end points include sudden cardiac death , cardiovascular death , myocardial infarction , and measures of quality of life and cost-effectiveness .


The evaluation of long-term safety will include all-cause mortality , stroke , transient ischemic attack , and hospitalization for heart failure .


Enrollment commenced in November 2011 and was completed in summer 2013 .


RIVER-PCI is a novel , large-scale , international , randomized , double-blind , placebo-controlled clinical trial evaluating the role of ranolazine in the long-term medical management of patients with ICR post-PCI .


postoperative pain increases the activity of the sympathetic system , causes hypermetabolic conditions , retains salt and water , increases glucose , fatty acid lactate and oxygen consumption , weakens the immunity system which delays wound healing .


Our object was comparison of the analgesic effect of morphine and paracetamol in the patients undergoing laparotomy , using PCA method .


Seventy patients who had undergone laparotomy were studied using double blind randomized clinical trial ( 35 patients received morphine and 35 paracetamol ) in the Shahid Rajaee Center and Velayat Hospital ( Qazvin , Iran ) .


People using opioids , painkillers and sedatives regularly and in large doses and patients with a history of lung or liver problems did not participate in this project .


The parameters of the severity of pain and nausea ( VAS ) , hemodynamic changes ( BP and HR ) , pruritus , arterial oxygen desaturation and patient satisfaction ( VAS ) of both groups were measured by a third party ( trained colleague ) .


The data was analyzed using SPSS 16 statistical software then descriptive results were extracted and ultimately the groups were compared using the following statistical tests : student 's T-test , chi 2 and Fisher 's exact test ( P < 0.05 ) .


The mean age of the participants was 4512.5 years .


Women constituted 24.3 % of the patients and men 75.7 % .


The average pain severity for morphine and paracetamol groups ( VAS ) was 5.32.2 and 6.371.7 after2 hours and reached 1.911.3 and 2.491.3 after 8 hours ( after the operation ) respectively .


There was a significant difference between the groups after 2 and 4 hours in terms of pain severity ( after 2 hours P = 0.007 and after 4 hours P = 0.047 ) .


However there was no significant difference between the average pain severity of the studied groups ( after 6 hours P = 0.4 and 8 hours P = 0.08 ) .


After 8 hours , the average nausea severity was the minimum in both groups being 1.711.6 and 1.431.1 in morphine and paracetamol groups respectively .


Nausea severity was higher after 2 hours in paracetamol group .


In morphine group , it was higher after 4 , 6 and 8 hours .


Difference between the groups was not significant .


The average satisfaction level ( VAS ) for morphine and paracetamol groups reached from 5.292.3 and 4.22.4 after 2 hours , to 7.941.8 and 7.692.1 after 8 hours ( after the operation ) , respectively .


The average satisfaction level of patients was higher in morphine group in 2,4,6 and 8 hours and except for , after 4 hours ( P = 0.01 ) , the satisfaction difference between both groups was not significant in other hours ( P = 0.06 after 2 hours , P = 0.6 after 6 hours and P = 0.5 after 8 hours )


Morphine seems to be more effective at 2 and 4 hours , but after 4 hours they have similar effects , the satisfaction difference between both groups was not significant in the patients .


To compare the clinical outcome of platform switching ( PS ) and regular platform ( RP ) implants in bilateral single molar replacements .


This study was designed as a randomised , controlled , split-mouth trial .


Eighteen patients , with bilaterally missing single molars had one site randomly assigned to a PS implant or a RP implant .


A total of 36 implants were bilaterally installed .


Both implants were loaded with screw retained temporary crowns 3 months after implant insertion and with screw retained definitive crowns 3 months later .


Outcome measures were implant/crown failure , complications , radiographic marginal bone-level changes , pocket probing depth ( PPD ) and bleeding on probing ( BOP ) .


Clinical data were collected at baseline 6 and 12 months after implant placement .


No patients dropped out and no implant failed .


No prosthetic or major biological complications were observed .


One year after implant placement , mean marginal bone level was 0.93 0.26 mm ( 95 % CI 0.81 to 1.05 ) in RP group and 0.84 0.23 mm ( 95 % CI 0.73 to 0.95 ) in the PS group and no statistically significant differences between the two groups were observed ( P = 0.18 ) .


Mean PPD and BOP values were , 6 and 12 months after implant placement , 2.74 0.49 mm ( 95 % CI 2.51 to 2.97 ) and 1.28 0.75 ( 95 % CI 0.93 to 1.63 ) in the RP group , and 2.70 0.38 mm ( 95 % CI 2.53 to 2.88 ) and 1.39 0.78 ( 95 % CI 1.03 to 1.75 ) in the PS group respectively , with no statistical differences between groups ( P = 0.81 and P = 0.16 , respectively ) .


No statistically significant difference was observed between platform switched and non-platform switched implants .


The use of structured curricula for minimally invasive surgery training is becoming increasingly popular .


However , many laparoscopic training programs still use basic skills and isolated task training , despite increasing evidence to support the use of training models with higher functional resemblance , such as whole procedural modules .


In contrast to basic skills training , procedural training involves several cognitive skills such as elements of planning , movement integration , and how to avoid adverse events .


The objective of this trial is to investigate the specificity of procedural practice in laparoscopic simulator training .


A randomised single-centre educational superiority trial .


Participants are 96 surgical novices ( medical students ) without prior laparoscopic experience .


Participants start by practicing a series of basic skills tasks to a predefined proficiency level on a virtual reality laparoscopy simulator .


Upon reaching proficiency , the participants are randomised to either the intervention group , which practices two procedures ( an appendectomy followed by a salpingectomy ) or to the control group , practicing only one procedure ( a salpingectomy ) on the simulator .


1:1 central randomisation is used and participants are stratified by sex and time to complete the basic skills .


Data collection is done at a surgical skills centre.The primary outcome is the number of repetitions required to reach a predefined proficiency level on the salpingectomy module .


The secondary outcome is the total training time to proficiency .


The improvement in motor skills and effect on cognitive load are also explored .


The results of this trial might provide new knowledge on how the technical part of surgical training curricula should be comprised in the future .


To examine the specificity of practice in procedural simulator training is of great importance in order to develop more comprehensive surgical curricula .


ClinicalTrials.gov : NCT02069951 .


Although cardiac troponin is associated with outcomes in atrial fibrillation ( AF ) , the complementary prognostic information provided by cardiac troponin I ( cTnI ) and cTnT is unknown .


This study investigated the distribution , determinants , and prognostic value of cTnI and cTnT concentrations in patients with AF .


Samples were collected .


At the time of randomization , we analyzed cTnI and cTnT concentrations of 14806 AF patients in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation ( ARISTOTLE ) trial using high-sensitivity assays .


Correlations ( Spearman ) , determinants ( multivariable linear regression ) , and outcomes ( adjusted Cox models and c-statistics ) were investigated .


Concentrations of cTnI and cTnT were correlated ( r = 0.70 ) and measurable in most participants [ cTnI 98.5 % ( median 5.4 ng/L , 99th percentile in 9.2 % ) and cTnT 93.5 % ( median 10.9 ng/L , 99th percentile in 34.4 % ) ] .


Renal impairment was the most important factor affecting the concentrations of both troponins .


cTnI increase was more associated with heart failure , vascular disease , and persistent/permanent AF , and cTnT with age , male sex , and diabetes .


Over a median 1.9 years of follow-up , patients with both troponins above the median had significantly higher risk for stroke/systemic embolism [ hazard ratio ( HR ) 1.72 ( 95 % CI 1.31-2 .27 ) ] , cardiac death [ 3.14 ( 2.35-4 .20 ) ] , and myocardial infarction [ 2.99 ( 1.78-5 .03 ) ] than those with both troponins below median ( all P < 0.005 ) .


Intermediate risks were observed when only 1 troponin was above the median .


When combined with clinical information , each marker provided similar prognostication and had comparable c-index .


cTnI and cTnT concentrations are moderately correlated and measurable in plasma of most AF patients .


The risk of stroke and cardiovascular events is highest when both troponins are above median concentrations .


Each troponin provides comparable prognostic information when combined with clinical risk factors .


ClinicalTrials.gov / NCT00412984 .


The aim of this study was to evaluate the effects and safety of a sleep aid for postoperative analgesia in patients undergoing arthroscopic rotator cuff repair .


Seventy-eight patients were prospectively assigned to either the zolpidem group ( multimodal analgesia + zolpidem ; 39 patients ) or the control group ( multimodal analgesia ; 39 patients ) .


Self-rated pain levels were assessed twice a day using a visual analog scale ( VAS ) .


The need for additional rescue analgesic , duration of functional recovery , and adverse effects were assessed for the first 5 days after surgery .


The mean number of times that additional rescue analgesic was required during 5 days after surgery was 2.12.0 in the zolpidem group and 3.32.8 in the control group , a significant difference .


There were no significant differences between the two groups in mean VAS pain scores during the first 5 days after surgery , although the zolpidem group had lower VAS pain scores than the control group .


Additionally , there were no significant differences in duration of functional recovery and adverse effects between the two groups .


The use of zolpidem for analgesia after arthroscopic rotator cuff repair provided a significant reduction in the need for rescue analgesic without increasing adverse effects .


Nevertheless , mean VAS pain scores during the first 5 days after surgery did not differ between the zolpidem group and the control group .


Surgical resection plus adjuvant platinum-based chemotherapy is considered standard care for stage II to III non-small-cell lung cancer ( NSCLC ) , but its efficacy is limited , and it involves toxic risks , justifying patient-tailored treatment .


Excision repair cross-complementation group 1 ( ERCC1 ) was shown to predict cisplatin-based chemotherapy response ; EGFR mutations were predictive of epidermal growth factor receptor inhibition response .


This prospective randomized phase II trial enrolled 150 patients with completely resected non-squamous cell stage II or IIIA ( non-N2 ) tumors .


Patients in the control arm ( n = 74 ) were treated with four standard-dose courses of cisplatin plus pemetrexed ( CP ) .


In the customized treatment arm ( n = 76 ) , patients with activated EGFR mutations received erlotinib 150 mg for 1 year ; ERCC1-negative patients received four CP courses , whereas ERCC1-positive patients underwent follow-up .


The trial sought to demonstrate the feasibility of customized adjuvant chemotherapy based on timely biomarker analysis within a 2-month postsurgery delay .


Secondary objectives were tolerability , compliance with adjuvant therapy , and biomarker distribution .


In arm A , all patients received CP ; in arm B , seven received erlotinib , 53 were administered CP , and 16 underwent follow-up .


Median erlotinib exposure was 344 days .


Of the 127 patients allocated to CP , 82 % received four cycles with good tolerability .


The overall success rate of the trial ( ie , percentage of patients with complete biomarker status able to start adjuvant treatment within 2 months of surgery ) was 80 % .


The primary end point of the trial was met , demonstrating the feasibility of a national biology-driven trial in the adjuvant NSCLC setting .


Nevertheless , the phase III part was canceled because of the unreliability of the ERCC1 immunohistochemical readouts .


The phosphodiesterase inhibitors are used in the treatment of ED and there are increasing data of effects of these drugs on bladder and urethral relaxation as well as of prostatic smooth muscles that may relief the symptoms of BPH .


This study was conducted to evaluate the role of Tadalafil ( a PDE-5 inhibitor ) in combination with standard therapy for the treatment of BPH .


In this randomized clinical trial of 165 patients with obstructive and irritative urinary tract symptoms due to BPH , IPSS 8 , Iief 11 , Q-max from 5 mL/s to 15 mL/s and residual urine volume ( RUV ) < 120 mL , there was indication for surgical intervention .


These patients were randomly allocated in three groups .


Each patient received a therapeutic treatment daily for 12 weeks .


Group A received treatment with tamsulosin 0.4 mg and tadalafil 5 mg , Group B received a standard treatment with tamsulosin 0.4 mg for BPH and Group C received only one treatment with tadalafil 5 mg .


There was no significant difference in terms of IPSS score , Qmax and RUV before treatment in the three groups tested .


Analysis of the data shows that in patients treated with tamsulosin and tadalafil IPSS , IIEF and QoL were significantly improved in a different way than in the other two groups , while the Qmax and RUV did not show a significant change in the three groups , remaining almost constant .


The PDE-5 inhibitor improves quality of life and urinary symptoms in patients with LUTS suggestive of BPH , but does n't have any significant effect on Qmax and RUV .


This article presents the results of research based on the feelings and responses of members of a sports club , in relation to a fitness programme offered by Fitness World .


The study consisted of a group of 58 participants chosen at random .


Statistically , the analysed results of the research show that the biggest group attending Fitness World consists of men between 31 and 50 years of age with higher education , and women between 18 and 30 with , mostly , higher education .


In general , men prefer to participate in aerobics group sessions and gym sessions , and women choose to take part in any activities .


The most preferred time was between 5 p.m. and 10 p.m. , usually after work , and with a frequency of twice a week .


It was not possible to determine the main reasons for motivation , although 93 % prefer to practise regularly .


To generate comparative clinical data in Indian patients with acute coronary syndrome ( ACS ) in terms of safety and efficacy of atorvastatin 80 mg vis -- vis atorvastatin 40 mg


A total of 236 patients with diagnosed ACS ( with TIMI Risk score > or = 3 ) within preceding 10 days were randomized to receive either atorvastatin 80 mg or atorvastatin 40 mg once daily for 12 weeks .


Out of 236 patients , data for 173 was analyzed who had both baseline and post-baseline lipid assessment .


The primary end point of the trial was percentage change in LDL-C at the end of treatment from baseline .


Other end points were change in high sensitivity C reactive protein , incidence of increase in liver enzymes > or = 3 times upper limit of normal and incidence of myotoxicity ( with or without elevation of creatinine phosphokinase ) at the end of treatment .


A dose-dependent response was observed with greater reduction of LDL - C in atorvastatin 80 mg ( 27.5 % vs 19.04 % ) than that of atorvastatin 40 mg group .


Both the treatment groups had a significant reduction ( p < 0.001 ) in LDL-C at the end of 6 and 12 weeks in comparison to baseline .


hs-CRP was also significantly reduced ( p < 0.001 ) in both the treatment groups i.e. atorvastatin 80 mg ( 76.15 % ) and atorvastatin 40 mg ( 84.4 % ) from baseline at the end of 12 weeks .


Both doses of atorvastatin were well tolerated .


No patient had elevation of ( > or = 3 times of upper limit of normal ) liver enzymes or creatinine phosphokinase .


One patient on atorvastatin 80 mg complained of myalgia .


There were no dose-related differences in incidence of adverse events between two treatment groups .


The CURE-ACS trial indicated that atorvastatin 80 mg was more effective than atorvastatin 40 mg in terms of reduction in LDL cholesterol and was as safe and well tolerated as 40 mg dose in Indian patients with ACS .


With high-fidelity simulators in a modern blended learning setting , students are able to acquire knowledge and practical skills in acute medicine in realistic scenarios .


However , it has not yet been clarified if the sequence of linking between knowledge and simulator-based training of practical skills plays an important role for increasing knowledge , for the self-concept and learning emotions of trainees .


In a pilot study the influence of the type of knowledge acquisition under two independent conditions was investigated in which the order of presenting the learning material ( firstly theory and then simulation vs. simulation elements before the theory ) was reversed .


In addition the influence of individual attributes of personality on the construction of situated knowledge was correlated with these conditions in two groups .


To investigate the outcome of simulator-based learning 20 students were randomly allocated to one of the two conditions and undertook two scenarios ( anaphylactic shock and myocardial infarction ) , whereby the theoretical lessons were given either before or after the scenarios .


Using standardized questionnaires and problem-centered semi-standardized interviews , the following variables of the participants were assessed : personality traits , current positive and negative feelings , professional self-concept , general self-efficacy and coping strategies for stress .


Theoretical knowledge and practical skills were assessed using a knowledge test and standardized assessment questionnaires which also focused on performance and patient safety .


All together the results showed a slight advantage for the condition of theory before simulation which was not determined by the acquisition of knowledge but by a better performance of trainees as assessed by the trainers .


Regarding knowledge acquisition , no statistically significant differences could be shown .


Significant differences ( p < 0.05 ) were found for negative feelings ( very intense negative emotional state ) and for the professional self-concept ( perception of own professional skills ) in favor of the theory then simulation condition .


More extrovert participants showed poorer results which could not be attributed to one of the conditions .


However , the participants always assessed the allocated learning condition as the best premise for effective learning outcome .


Reaction to stress has been described as `` jumping in at the deep end '' as well as the lasting effect on learning from errors .


In the context of simulation-based teaching , the learning outcome not only depends on knowledge , practical skills and motivational variables but also on the presence of negative feelings , ability self-concepts and various personality traits .


There was a trend which showed that simulation in the field of anesthesiology and emergency medicine should be set up with the theoretical basis first in order to avoid negative feelings .


To evaluate the relative efficacy and safety of extended-release tramadol HCl 75mg/acetaminophen 650mg ( TA-ER ) and immediate-release tramadol HCl 37.5 mg/acetaminophen 325mg ( TA-IR ) for the treatment of moderate to severe acute pain following total knee replacement .


This phase III , double-blind , placebo-controlled , parallel-group study randomized 320 patients with moderate to severe pain ( 4 intensity on an 11 point numeric rating scale ) following total knee replacement arthroplasty to receive oral TA-ER ( every 12 hours ) or TA-IR ( every 6 hours ) over a period of 48 hours .


In the primary analysis , TA-ER was evaluated for efficacy non-inferior to that of TA-IR based on the sum of pain intensity difference ( SPID ) at 48 hours after the first dose of study drug ( SPID48 ) .


Secondary endpoints included SPID at additional time points , total pain relief at all on-therapy time points ( TOTPAR ) , sum of SPID and TOTPAR at all on-therapy time points ( SPID+TOTPAR ) , use of rescue medication , subjective pain assessment ( PGIC , Patient Global Impression of Change ) , and adverse events ( AEs ) .


Analysis of the primary efficacy endpoint ( SPID48 ) could not establish the non-inferiority of TA-ER to TA-IR .


However , a post hoc analysis with a re-defined non-inferiority margin did demonstrate the non-inferiority of TA-ER to TA-IR .


No statistically significant difference in SPID at 6 , 12 , or 24 hours was observed between the TA-ER and TA-IR groups .


Similarly , analysis of TOTPAR showed that there were no significant differences between groups at any on-therapy time point , and SPID+TOTPAR at 6 and 48 hours were similar among groups .


There was no difference in the mean frequency or dosage of rescue medication required by both groups , and the majority of patients in both the TA-ER and TA-IR groups rated their pain improvement as ` much ' or ` somewhat better ' .


The overall incidence of 1 AEs was similar among the TA-ER ( 88.8 % ) and TA-IR ( 89.5 % ) groups .


The most commonly reported AEs by patients treated with TA-ER and TA-IR included nausea ( 49.7 % vs 44.4 % ) , vomiting ( 28.0 % vs 24.2 % ) , and decreased hemoglobin ( 23.6 % vs 26.1 % ) .


This study is limited by the lack of placebo control , and the invalidity of the initial non-inferiority margin .


This study demonstrated that the analgesic effect of TA-ER is non-inferior to TA-IR , and supports TA-ER as an effective and safe treatment for moderate to severe acute pain post total knee replacement .


Clinicaltrials.gov , NCT01814878 .


Methotrexate is a first-line systemic agent for treating of psoriasis , although its onset of effects is slower and overall it is less effective than tumor necrosis factor blockers .


To differentiate the response of psoriatic disease to adalimumab and methotrexate sodium .


Single-center , randomized , assessor-blind , 2-arm clinical trial of 30 patients from the outpatient dermatology center of Tufts Medical Center , enrolled from August 18 , 2009 , to October 11 , 2011 .


Patients aged 18 to 85 years with chronic plaque-type psoriasis , a minimum Physician Global Assessment score of 3 ( higher scores indicate more severe disease ) , and a psoriatic plaque of at least 2 cm were randomized in a 1:1 fashion to receive subcutaneous adalimumab or oral methotrexate .


Skin biopsy specimens obtained at baseline and weeks 1 , 2 , 4 , and 16 were given a histologic grade by blinded assessors to evaluate treatment response .


Analyses were conducted from April 16 , 2013 , to January 5 , 2015 .


A 16-week course of subcutaneous adalimumab ( 40 mg every 2 weeks after a loading dose ) or low-dosage oral methotrexate sodium ( 7.5-25 mg/wk ) .


Changes in genomic , immunohistochemical , and messenger RNA ( mRNA ) profiles .


Methotrexate responders experienced significant downregulation of helper T-cell-related ( T ( H ) 1 , T ( H ) 17 , and T ( H ) 22 ) mRNA expression compared with methotrexate nonresponders .


Comparisons among adalimumab-treated patients were limited by the number of nonresponders ( n = 1 ) .


Between adalimumab and methotrexate responders , we found no significant differences in gene expression at any study point or in the expression of T-cell-related mRNA at week 16 .


Adalimumab responders demonstrated early downregulation of chemokine ( C-C motif ) ligand 20 ( CCL20 ) mRNA ( mean [ SE ] at week 2 , -1.83 [ 0.52 ] , P < .001 ; week 16 , -3.55 [ 0.54 ] , P < .001 ) compared with late downregulation for methotrexate responders ( week 2 , 0.02 [ 0.51 ] , P = .96 ; week 16 , -2.96 [ 0.51 ] , P < .001 ) .


Similar differences were observed with interleukin 22 ( IL22 ) mRNA showing early downregulation for adalimumab responders ( week 2 , -3.17 [ 1.00 ] , P < .001 ; week 16 , -3.58 [ 1.00 ] , P < .001 ) compared with late downregulation for methotrexate responders ( week 2 , -0.44 [ 0.68 ] , P = .64 ; week 16 , -5.14 [ 0.68 ] , P < .001 ) .


Analysis of variance findings for key mRNA and immunohistochemical marker expression over the study course were significant only for CCL20 ( P = .03 ) and IL22 ( P = .006 ) mRNA comparing adalimumab and methotrexate responders .


Methotrexate is an immunomodulator with effects on helper T-cell signaling in psoriasis .


Similar genomic and immunohistochemical response signatures and levels of mRNA downregulation at study completion among adalimumab and methotrexate responders suggest a disease-driven instead of therapeutic-driven pathway regulation .


Adalimumab and methotrexate responses are differentiated by patterns of normalization of CCL20 and IL22 mRNA expression and may explain the varied onset and degree of clinical responses by each treatment .


clinicaltrials.gov Identifier : NCT00932113 .


The need to prevent reflux in the construction of an orthotopic ileal neobladder is controversial .


We designed the USC-STAR trial to determine whether the T-pouch neobladder that included an antireflux mechanism was superior to the Studer pouch in patients with bladder cancer undergoing radical cystectomy .


This single center , randomized , controlled trial recruited patients with clinically nonmetastatic bladder cancer scheduled to undergo radical cystectomy with neobladder .


Eligible patients were randomly assigned to undergo T-pouch or Studer ileal orthotopic neobladder .


Treatment assignment was not masked .


The primary end point was change in renal function from baseline to 3 years .


The CKD-EPI ( Chronic Kidney Disease Epidemiology Collaboration ) equation was used to calculate the estimated glomerular filtration rate .


Between February 2002 and November 2009 , 237 patients were randomly assigned to T-pouch ileal orthotopic neobladder and 247 to Studer ileal orthotopic neobladder .


Baseline characteristics did not differ between the groups .


Between baseline and 3 years the estimated glomerular filtration rate decreased by 6.4 ml/minute/1 .73 m ( 2 ) in the Studer group and 6.6 ml/minute/1 .73 m ( 2 ) in the T-pouch group ( p = 0.35 ) .


Multivariable analysis showed that type of ileal orthotopic neobladder was not independently associated with 3-year renal function ( p = 0.63 ) .


However , baseline estimated glomerular filtration rate , age and urinary tract obstruction were independently associated with 3-year decline in renal function .


Cumulative risk of urinary tract infection and overall late complications were not different between the groups , but the T-pouch was associated with an increased risk of secondary diversion related surgeries .


T-pouch ileal orthotopic neobladder with an antireflux mechanism did not prevent a moderate reduction in renal function observed at 3 years compared to the Studer pouch , but did result in an increase in diversion related secondary surgical procedures .


Facial affect recognition , a basic building block of social cognition , is often impaired in schizophrenia .


Poor facial affect recognition is closely related to poor functional outcome ; however , neither social cognitive impairments nor functional outcome are sufficiently improved by antipsychotic drug treatment alone .


Adjunctive repetitive transcranial magnetic stimulation ( rTMS ) has been shown to enhance cognitive functioning in both healthy individuals and in people with neuropsychiatric disorders and to ameliorate clinical symptoms in psychiatric disorders , but its effects on social cognitive impairments in schizophrenia have not yet been studied .


Therefore , we evaluated the effects of sham-controlled rTMS on facial affect recognition in patients with chronic schizophrenia .


Inpatients ( N = 36 ) on stable antipsychotic treatment were randomly assigned to double-blind high-frequency ( 10 Hz ) rTMS or sham stimulation for a total of ten sessions over two weeks .


In the verum group , each session consisted of 10 000 stimuli ( 20 trains of 5 s ) applied over the left dorsolateral prefrontal cortex at 110 % of motor threshold .


Facial affect recognition was assessed before ( T0 ) and after ( T1 ) the ten sessions .


Facial affect recognition improved significantly more after rTMS ( accuracy change : mean = 8.9 % , SD = 6.0 % ) than after sham stimulation ( mean = 1.6 % , SD = 3.5 ; Cohen 's d = 1.45 ) .


There was no correlation with clinical improvement .


Our results indicate that prefrontal 10 Hz rTMS stimulation may help to ameliorate impaired facial affect recognition in schizophrenia .


Early clinical studies suggested that the anti-interleukin-17 receptor A monoclonal antibody brodalumab has efficacy in the treatment of psoriasis .


In two phase 3 studies ( AMAGINE-2 and AMAGINE-3 ) , patients with moderate-to-severe psoriasis were randomly assigned to receive brodalumab ( 210 mg or 140 mg every 2 weeks ) , ustekinumab ( 45 mg for patients with a body weight 100 kg and 90 mg for patients > 100 kg ) , or placebo .


At week 12 , patients receiving brodalumab were randomly assigned again to receive a brodalumab maintenance dose of 210 mg every 2 weeks or 140 mg every 2 weeks , every 4 weeks , or every 8 weeks ; patients receiving ustekinumab continued to receive ustekinumab every 12 weeks , and patients receiving placebo received 210 mg of brodalumab every 2 weeks .


The primary aims were to evaluate the superiority of brodalumab over placebo at week 12 with respect to at least a 75 % reduction in the psoriasis area-and-severity index score ( PASI 75 ) and a static physician 's global assessment ( sPGA ) score of 0 or 1 ( clear or almost clear skin ) , as well as the superiority of brodalumab over ustekinumab at week 12 with respect to a 100 % reduction in PASI score ( PASI 100 ) .


At week 12 , the PASI 75 response rates were higher with brodalumab at the 210-mg and 140-mg doses than with placebo ( 86 % and 67 % , respectively , vs. 8 % [ AMAGINE-2 ] and 85 % and 69 % , respectively , vs. 6 % [ AMAGINE-3 ] ; P < 0.001 ) ; the rates of sPGA scores of 0 or 1 were also higher with brodalumab ( P < 0.001 ) .


The week 12 PASI 100 response rates were significantly higher with 210 mg of brodalumab than with ustekinumab ( 44 % vs. 22 % [ AMAGINE-2 ] and 37 % vs. 19 % [ AMAGINE-3 ] , P < 0.001 ) .


The PASI 100 response rates with 140 mg of brodalumab were 26 % in AMAGINE-2 ( P = 0.08 for the comparison with ustekinumab ) and 27 % in AMAGINE-3 ( P = 0.007 ) .


Rates of neutropenia were higher with brodalumab and with ustekinumab than with placebo .


Mild or moderate candida infections were more frequent with brodalumab than with ustekinumab or placebo .


Through week 52 , the rates of serious infectious episodes were 1.0 ( AMAGINE-2 ) and 1.3 ( AMAGINE-3 ) per 100 patient-years of exposure to brodalumab .


Brodalumab treatment resulted in significant clinical improvements in patients with moderate-to-severe psoriasis .


( Funded by Amgen ; AMAGINE-2 and AMAGINE-3 ClinicalTrials.gov numbers , NCT01708603 and NCT01708629 . )


The significance of basal renal nitric oxide ( NO ) availability in the regulation of renal perfusion and sodium excretion in human congestive heart failure ( CHF ) has not been described previously .


We studied the effects of acute systemic NO synthesis inhibition with N ( G ) - monomethyl-L-arginine ( L-NMMA ) in 12 patients with CHF and 10 healthy control subjects ( CON ) in a randomized placebo-controlled study .


Effect parameters were renal plasma flow ( RPF ) , renal vascular resistance ( RVR ) , glomerular filtration rate ( GFR ) , urine sodium excretion and plasma levels of vasoactive hormones .


L-NMMA was associated with a significant decrease in RPF ( CON-LNMMA : -13 3 % [ P = .014 ] ; CHF-LNMMA : -17 7 % [ P = .017 ] ) and a profound increase in RVR in both CHF and CON ( CON-LNMMA : +26 6 % [ P = .009 ] ; CHF-LNMMA : +37 70 % [ P = .005 ] ) .


Significant decreases in sodium excretion were found in both CHF-LNMMA and CON-LNMMA .


Relative changes from baseline were not statistically different between CHF-LNMMA and CON-LNMMA .


After L-NMMA , RPF values correlated inversely with plasma aldosterone in CHF-LNMMA ( P = .01 ) .


L-NMMA induced an increase in A-type natriuretic peptide ( ANP ) only in CHF-LNMMA ( +18 8 % ; P = .035 ) , which correlated significantly with basal ANP levels ( P = .034 ) .


There was no difference in the renal response to L-NMMA in CHF vs CON , suggesting that the impact of NO on renal perfusion and sodium excretion is maintained in stable CHF .


We suggest that NO influences the release of ANP during high levels of atrial stretch in CHF .


Adipose-derived regenerative cells ( ADRCs ) can be isolated from liposuction aspirates and prepared as fresh cells for immediate administration in cell therapy .


We performed the first randomized , placebo-controlled , double-blind trial to examine the safety and feasibility of the transendocardial injections of ADRCs in no-option patients with ischemic cardiomyopathy .


Procedural , postoperative , and follow-up safety end points were monitored up to 36 months .


After baseline measurements , efficacy was assessed by echocardiography and single-photon emission computed tomography ( 6 , 12 , and 18 months ) , metabolic equivalents and maximal oxygen consumption ( MVO2 ) ( 6 and 18 months ) , and cardiac magnetic resonance imaging ( 6 months ) .


We enrolled 21 ADRC-treated and 6 control patients .


Liposuction was well tolerated , ADRCs were successfully prepared , and transendocardial injections were feasible in all patients .


No malignant arrhythmias were seen .


Adverse events were similar between groups .


Metabolic equivalents and MVO2 values were preserved over time in ADRC-treated patients but declined significantly in the control group .


The difference in the change in MVO2 from baseline to 6 and 18 months was significantly better in ADRC-treated patients compared with controls .


The ADRC-treated patients showed significant improvements in total left ventricular mass by magnetic resonance imaging and wall motion score index .


Single-photon emission computed tomography results suggested a reduction in inducible ischemia in ADRC-treated patients up to 18 months .


Isolation and transendocardial injection of autologous ADRCs in no-option patients were safe and feasible .


Our results suggest that ADRCs may preserve ventricular function , myocardial perfusion , and exercise capacity in these patients .


The treatment of cancer patients with mistletoe extract is said to prolong their survival and , above all , improve their quality of life .


We studied whether the quality of life of patients with advanced pancreatic cancer could be improved by mistletoe extract .


An open , single-center , group-sequential , randomized phase III trial ( ISRCTN70760582 ) was conducted .


From January 2009 to December 2010 , 220 patients with locally advanced or metastatic pancreatic cancer who were receiving no further treatment for pancreatic cancer other than best supportive care were included in this trial .


They were stratified by prognosis and randomly allocated either to a group that received mistletoe treatment or to one that did not .


Mistletoe extract was given in escalating doses by subcutaneous injection three times a week .


The planned interim evaluation of data from 220 patients indicated that mistletoe treatment was associated with longer overall survival , and the trial was terminated prematurely .


After termination of the study , the results with respect to quality of life ( assessed with the QLO-C30 scales of the European Organisation for Research and Treatment of Cancer ) and trends in body weight were evaluated .


Data on quality of life and body weight were obtained from 96 patients treated with mistletoe and 72 control patients .


Those treated with mistletoe did better on all 6 functional scales and on 7 of 9 symptom scales , including pain ( 95 % confidence interval [ CI ] -29 to -17 ) , fatigue ( 95 % CI -36.1 to -25.0 ) , appetite loss ( 95 % CI -51 to -36.7 ) , and insomnia ( 95 % CI -45.8 to -28.6 ) .


This is reflected by the trend in body weight during the trial .


In patients with locally advanced or metastatic pancreatic carcinoma , mistletoe treatment significantly improves the quality of life in comparison to best supportive care alone .


Mistletoe is an effective second-line treatment for this disease .


Immunohistochemical assessment of liver tissue in chronic delta hepatitis ( CDH ) is underinvestigated .


Aim of the study was ( i ) to assess variables associated with hepatitis D antigen ( HDAg ) , hepatitis B surface antigen ( HBsAg ) and hepatitis B core antigen ( HBcAg ) staining in the liver .


Demographic , biochemical and virologic data collected from the HIDIT 1 study were used .


HBsAg , HBcAg and HDAg immunohistochemical ( IHC ) staining was semiquantitatively assessed .


Hepatitis D antigen immunohistochemical staining displayed positive correlations with age and alanine aminotransferase ( ALT ) and negative correlations with serum HBsAg ( P = 0.01 for all ) .


HBsAg IHC displayed a negative correlation with gamma glutamyl transferase and positive correlations with serum HBV DNA , serum HBsAg levels and HBeAg serology ( P < 0.001 , P = 0.02 and P = 0.007 respectively ) .


HBcAg staining was mainly nuclear and displayed negative correlations with serum HBsAg and histologic activity ( P = 0.002 and P = 0.02 respectively ) .


Pegylated IFN based treatment led to a decline of all IHC markers , however , these markers had no impact on treatment outcome .


These data suggest an association of liver injury with HDAg expression in CDH whereas the negative correlation between HBcAg expression and liver injury and the overall nuclear localization of HBcAg suggest that HBcAg does not contribute to liver injury in CDH .


HDV cases with high level of HBV replication , high serum HBsAg levels , HBeAg positivity , that are probably in the earlier stages of disease ( low gamma-glutamyl transferase ) , had a more intense HBsAg staining profile .


Overall , the data enforce the importance of HDAg and HBsAg in different phases of CDH infection .


The traditional treatment for primary anterior shoulder dislocations has been immobilization in a sling with the arm in a position of adduction and internal rotation .


However , recent basic science and clinical data have suggested recurrent instability may be reduced with immobilization in external rotation after primary shoulder dislocation .


We performed a randomized controlled trial to compare the ( 1 ) frequency of recurrent instability and ( 2 ) disease-specific quality-of-life scores after treatment of first-time shoulder dislocation using either immobilization in external rotation or immobilization in internal rotation in a group of young patients .


Sixty patients younger than 35 years of age with primary , traumatic , anterior shoulder dislocations were randomized ( concealed , computer-generated ) to immobilization with either an internal rotation sling ( n = 29 ) or an external rotation brace ( n = 31 ) at a mean of 4 days after closed reduction ( range , 1-7 days ) .


Patients with large bony lesions or polytrauma were excluded .


The two groups were similar at baseline .


Both groups were immobilized for 4 weeks with identical therapy protocols thereafter .


Blinded assessments were completed by independent observers for a minimum of 12 months ( mean , 25 months ; range , 12-43 months ) .


Recurrent instability was defined as a second documented anterior dislocation or multiple episodes of shoulder subluxation severe enough for the patient to request surgical stabilization .


Validated disease-specific quality-of-life data ( Western Ontario Shoulder Instability index [ WOSI ] , American Shoulder and Elbow Surgeons evaluation [ ASES ] ) were also collected .


Ten patients ( 17 % , five from each group ) were lost to followup .


Reported compliance with immobilization in both groups was excellent ( 80 % ) .


With the numbers available , there was no difference in the rate of recurrent instability between groups : 10 of 27 patients ( 37 % ) with the external rotation brace versus 10 of 25 patients ( 40 % ) with the sling redislocated or developed symptomatic recurrent instability ( p = 0.41 ) .


WOSI scores were not different between groups ( p = 0.74 ) and , although the difference in ASES scores approached statistical significance ( p = 0.05 ) , the magnitude of this difference was small and of uncertain clinical importance .


Despite previous published findings , our results show immobilization in external rotation did not confer a significant benefit versus sling immobilization in the prevention of recurrent instability after primary anterior shoulder dislocation .


Further studies with larger numbers may elucidate whether functional outcomes , compliance , or comfort with immobilization can be improved with this device .


Level I , therapeutic study .


See Instructions for Authors for a complete description of levels of evidence .


We studied the correlation between outer nuclear layer ( ONL ) thickness and cone density in normal eyes and eyes with retinitis pigmentosa ( RP ) .


Spectral-domain optical coherence tomography ( SD-OCT ) scans were acquired using a displaced pupil entry position of the scanning beam to distinguish Henle 's fiber layer from the ONL in 20 normal eyes ( 10 subjects ) and 12 eyes with RP ( 7 patients ) .


Cone photoreceptors were imaged using adaptive optics scanning laser ophthalmoscopy .


The ONL thickness and cone density were measured at 0.5 intervals along the horizontal meridian through the fovea nasally and temporally .


The ONL thickness and cone density were correlated using Spearman 's rank correlation coefficient r.


Cone densities averaged over the central 6 were lower in eyes with RP than normal , but showed high variability in both groups .


The ONL thickness and cone density were significantly correlated when all retinal eccentricities were combined ( r = 0.74 ) ; the correlation for regions within 0.5 to 1.5 eccentricity was stronger ( r = 0.67 ) than between 1.5 and 3.0 eccentricity ( r = 0.23 ) .


Although cone densities were lower between 0.5 and 1.5 in eyes with RP , ONL thickness measures at identical retinal locations were similar in the two groups ( P = 0.31 ) , and interindividual variation was high for ONL and cone density measures .


Although ONL thickness and retinal eccentricity were important predictors of cone density , eccentricity was over 3 times more important .


The ONL thickness and cone density were correlated in normal eyes and eyes with RP , but both were strongly correlated with retinal eccentricity , precluding estimation of cone density from ONL thickness .


( ClinicalTrials.gov number , NCT00254605 . )


The role of procalcitonin ( PCT ) , a widely used sepsis biomarker , in critically ill patients with sepsis is undetermined .


To investigate the effect of a low PCT cut-off on antibiotic prescription and to describe the relationships between PCT plasma concentration and sepsis severity and mortality .


This was a multicenter ( 11 Australian intensive care units [ ICUs ] ) , prospective , single-blind , randomized controlled trial involving 400 patients with suspected bacterial infection/sepsis and expected to receive antibiotics and stay in ICU longer than 24 hours .


The primary outcome was the cumulative number of antibiotics treatment days at Day 28 .


PCT was measured daily while in the ICU .


A PCT algorithm , including 0.1 ng/ml cut-off , determined antibiotic cessation .


Published guidelines and antimicrobial stewardship were used in all patients .


Primary analysis included 196 ( PCT ) versus 198 standard care patients .


Ninety-three patients in each group had septic shock .


The overall median ( interquartile range ) number of antibiotic treatment days were 9 ( 6-21 ) versus 11 ( 6-22 ) , P = 0.58 ; in patients with positive pulmonary culture , 11 ( 7-27 ) versus 15 ( 8-27 ) , P = 0.33 ; and in patients with septic shock , 9 ( 6-22 ) versus 11 ( 6-24 ) , P = 0.64 ; with an overall 90-day all-cause mortality of 35 ( 18 % ) versus 31 ( 16 % ) , P = 0.54 in the PCT versus standard care , respectively .


Using logistic regression , adjusted for age , ventilation status , and positive culture , the decline rate in log ( PCT ) over the first 72 hours independently predicted hospital and 90-day mortality ( odds ratio [ 95 % confidence interval ] , 2.76 [ 1.10-6 .96 ] , P = 0.03 ; 3.20 [ 1.30-7 .89 ] , P = 0.01 , respectively ) .


In critically ill adults with undifferentiated infections , a PCT algorithm including 0.1 ng/ml cut-off did not achieve 25 % reduction in duration of antibiotic treatment .


Clinical trial registered with http://www.anzctr.org.au ( ACTRN12610000809033 ) .


In contrast to drug-sensitive tuberculosis , the guidelines for the treatment of multi-drug-resistant tuberculosis ( MDR-TB ) have a very poor evidence base ; current recommendations , based on expert opinion , are that patients should be treated for a minimum of 20 months .


A series of cohort studies conducted in Bangladesh identified a nine-month regimen with very promising results .


There is a need to evaluate this regimen in comparison with the currently recommended regimen in a randomized controlled trial in a variety of settings , including patients with HIV-coinfection .


STREAM is a multi-centre randomized trial of non-inferiority design comparing a nine-month regimen to the treatment currently recommended by the World Health Organization in patients with MDR pulmonary TB with no evidence on line probe assay of fluoroquinolone or kanamycin resistance .


The nine-month regimen includes clofazimine and high-dose moxifloxacin and can be extended to 11 months in the event of delay in smear conversion .


The primary outcome is based on the bacteriological status of the patients at 27 months post-randomization .


Based on the assumption that the nine-month regimen will be slightly more effective than the control regimen and , given a 10 % margin of non-inferiority , a total of 400 patients are required to be enrolled .


Health economics data are being collected on all patients in selected sites .


The results from the study in Bangladesh and cohorts in progress elsewhere are encouraging , but for this regimen to be recommended more widely than in a research setting , robust evidence is needed from a randomized clinical trial .


Results from the STREAM trial together with data from ongoing cohorts should provide the evidence necessary to revise current recommendations for the treatment for MDR-TB .


This trial was registered with clincaltrials.gov ( registration number : ISRCTN78372190 ) on 14 October 2010 .


To determine the effectiveness of part-time patching for treating intermittent exotropia ( IXT ) in young children .


Multicenter , randomized clinical trial .


Two hundred one children 12 to 35 months of age with untreated IXT meeting the following criteria : ( 1 ) IXT at distance OR constant exotropia at distance and either IXT or exophoria at near , and ( 2 ) 15-prism diopter ( ) or more exodeviation at distance or near by prism and alternate cover test ( PACT ) but at least 10 exodeviation at distance by PACT .


Participants were assigned randomly to either observation ( no treatment for 6 months ) or patching prescribed for 3 hours daily for 5 months , followed by 1 month of no patching .


The primary outcome was deterioration , defined as constant exotropia measuring at least 10 at distance and near or receipt of nonprotocol treatment for IXT .


Of the 177 participants ( 88 % ) completing the 6-month primary outcome examination , deterioration occurred in 4.6 % ( 4 of 87 ) of the participants in the observation group and in 2.2 % ( 2 of 90 ) of the participants in the patching group ( difference , 2.4 % ; P = 0.27 ; 95 % confidence interval , -3.8 % to +9.4 % ) .


Motor deterioration occurred in 2.3 % ( 2 of 87 ) of the observation group and in 2.2 % ( 2 of 90 ) of the patching group ( difference , 0.08 % ; P = 0.55 ; 95 % confidence interval , -5.8 % to +6.1 % ) .


For the observation and patching groups , respectively , 6-month mean PACT measurements were 27.9 versus 24.9 at distance ( P = 0.02 ) and 19.3 versus 17.0 at near ( P = 0.10 ) ; 6-month mean exotropia control scores were 2.8 versus 2.3 points at distance ( P = 0.02 ) and 1.4 versus 1.1 points at near ( P = 0.26 ) .


Among children 12 to 35 months of age with previously untreated IXT , deterioration over 6 months was uncommon , with or without patching treatment .


There was insufficient evidence to recommend part-time patching for the treatment of IXT in children in this age group .


Despite ultrasound guidance for central line placement , complications persist , as exact needle location is often difficult to confirm with standard two-dimension ultrasound .


A novel real-time needle guidance technology has recently become available ( eZono , Germany ) that tracks the needle during insertion .


This randomized , blinded , crossover study examined whether this needle guidance technology improved cannulation of a simulated internal jugular ( IJ ) vein in an ultrasound phantom .


One hundred physicians were randomized to place a standard needle in an ultrasound neck phantom with or without the needle guidance system .


Video cameras were placed externally and within the lumens of the vessels to record needle location in real time .


The primary outcome measured was the rate of posterior wall puncture .


Secondary outcomes included number of carotid artery punctures , number of needle passes , final needle position , time to cannulation , and comfort level with this new technology .


The incidence of posterior vessel wall puncture without and with needle guidance was 49 and 13 % , respectively ( P < 0.001 , odds ratio [ OR ] = 7.33 [ 3.44 to 15.61 ] ) .


The rate of carotid artery puncture was higher without needle navigation technology than with needle navigation 21 versus 2 % , respectively ( P = 0.001 , OR = 12.97 [ 2.89 to 58.18 ] ) .


Final needle tip position being located within the lumen of the IJ was 97 % accurate with the navigation technology and 76 % accurate with standard ultrasound ( P < 0.001 , OR = 10.42 [ 2.76 to 40.0 ] ) .


Average time for successful vessel cannulation was 1.37 times longer without guidance technology .


This real-time needle guidance technology ( eZono ) shows significant improvement in needle accuracy and cannulation time during simulated IJ vein puncture .


To compare the hemodynamics after combined spinal-epidural anesthesia ( CSEA ) between decubitus and sitting positions in aged patients undergoing total hip replacement .


A total of 80 aged patients who underwent CSEA for elective total hip replacement were randomly divided into a decubitus position group ( group D ) and a sitting position group ( group S ; each group with 40 patients ) .


In group D , 10 mg of 0.5 % bupivacaine were given into the subarachnoid space in decubitus position .


In group S , 10 mg of 0.5 % bupivacaine were given into the subarachnoid space in the sitting position , which was maintained for 1 min , after which the patients were in decubitus position .


In both groups , the sensory block levels and changes in hemodynamics were assessed .


The mean arterial blood pressure was significantly higher in group S than in group D at each time point within 30 min after anesthesia .


There were no significant differences in heart rate between the two groups at each time point .


There was also no significant difference in the level of sensory block between the two groups 20 min after the administration of CSEA .


For aged patients undergoing total hip replacement , CSEA is safer and more effective in the sitting position than in decubitus position .


Pathological gambling is associated with elevated proportions of nicotine dependence , and tobacco smoking in pathological gamblers has been associated with increased problem-gambling severity .


This study examined the addition of N-acetylcysteine to imaginal desensitization in adults with co-occurring nicotine dependence and pathological gambling .


Twenty-eight individuals with co-occurring DSM-IV nicotine dependence and pathological gambling who were receiving behavioral therapy were recruited from December 2009 to February 2012 and randomized to augmentation with N-acetylcysteine or placebo in an 12-week , double-blind trial .


Subjects were assessed with measures of nicotine and gambling severity and followed for 3 months after treatment .


The primary outcomes were the Fagerstrm Test for Nicotine Dependence and the pathological gambling adaptation of the Yale-Brown Obsessive-Compulsive Scale .


During the first 6 weeks , there was a significant benefit of N-acetylcysteine treatment versus placebo on Fagerstrm Test for Nicotine Dependence total scores ( t = -2.224 ; P = .031 ) .


After the initial 6 weeks , all subjects significantly ( P < .001 ) benefited from imaginal desensitization .


During the 3-month follow-up , there was a significant additional benefit for N-acetylcysteine versus placebo on measures of problem-gambling severity ( t = 2.069 ; P = .043 ) .


N-acetylcysteine treatment during therapy facilitates long-term application of behavioral therapy techniques once patients are in the community after therapy has been completed .


ClinicalTrials.gov identifier : NCT00967005 .


To compare the effect of 800 vs 400 IU of daily oral vitamin D3 on the prevalence of vitamin D deficiency ( VDD ) at 40 weeks ' postmenstrual age ( PMA ) in preterm infants of 28 to 34 weeks ' gestation .


In this randomized double-blind trial , we allocated eligible infants to receive either 800 or 400 IU of vitamin D3 per day ( n = 48 in both groups ) .


Primary outcome was VDD ( serum 25-hydroxyvitamin D levels < 20 ng/mL ) at 40 weeks ' PMA .


Secondary outcomes were VDD , bone mineral content , and bone mineral density at 3 months ' corrected age ( CA ) .


Prevalence of VDD in the 800-IU group was significantly lower than in the 400-IU group at 40 weeks ( 38.1 % vs. 66.7 % ; relative risk : 0.57 ; 95 % confidence interval : 0.37-0 .88 ) and at 3 months ' CA ( 12.5 % vs. 35 % ; relative risk : 0.36 ; 95 % confidence interval : 0.14-0 .90 ) .


One infant ( 2.4 % ) in the 800-IU group had vitamin D excess ( 100-150 ng/mL ) .


Bone mineral content ( mean SD : 79.6 16.8 vs. 84.7 20.7 g ; P = .27 ) and bone mineral density ( 0.152 0.019 vs. 0.158 0.021 g/cm2 ; P = .26 ) were not different between the 2 groups .


Daily supplementation with 800 IU of vitamin D reduces the prevalence of VDD at 40 weeks ' PMA and at 3 months ' CA in preterm infants without showing any improvement in bone mineralization .


However , there is a possibility that this dose may occasionally result in vitamin D excess .


To explore the effect of early goal-directed therapy ( EGDT ) according to pulse indicated continuous cardiac output ( PiCCO ) on septic shock patients .


Eighty-two septic shock patients in Subei People 's Hospital of Jiangsu Province from January 2009 to December 2012 were enrolled and randomly divided into two groups using a random number table , standard surviving sepsis bundle group ( n = 40 ) and modified surviving sepsis bundles group ( n = 42 ) .


The patients received the standard EGDT bundles in standard surviving sepsis bundle group .


PiCCO catheter was placed in modified surviving sepsis bundles group .


Fluid resuscitation was guided by intrathoracic blood volume index ( ITBVI ) with the aim of 850-1 000 mL/m ( 2 ) .


Dobutamine was used to improve the heart function according to left ventricular contractile index ( dPmax ) and stroke volume index ( SVI ) .


The mean arterial blood pressure ( MAP ) was maintained 65 mmHg ( 1 mmHg = 0.133 kPa ) or above with norepinephrine .


Extra-vascular lung water was monitored for the titration of liquid and diuretics .


The acute physiology and chronic health evaluation II ( APACHEII ) score , sequential organ failure assessment ( SOFA ) score , the number of patients needed vasopressor , serum procalcitonin ( PCT ) , lactic acid and lactate extraction ratio , the amount of fluid resuscitation , duration of mechanical ventilation , duration of intensive care unit ( ICU ) stay , hospital mortality were recorded in both groups .


After treatment , the APACHEII score , SOFA score and the number of patients needed vasopressor were gradually reduced in both groups , and those in modified surviving sepsis bundle group were significantly lower than those of standard sepsis bundle group at 72 hours ( APACHEII score : 13.16.5 vs. 20.97.5 , SOFA score : 8.84.3 vs. 14.64.9 , the number of patients needed vasopressor : 8 vs. 17 , all P < 0.05 ) .


Arterial blood lactate clearance rate was gradually increased after treatment in both groups .


Lactate clearance rate in modified surviving sepsis bundle group was significantly higher than that of standard surviving sepsis bundle group [ 6 hours : ( 18.28.3 ) % vs. ( 10.87.5 ) % , t = -6.036 , P = 0.001 ; 12 hours : ( 22.67.3 ) % vs. ( 12.48.1 ) % , t = -4.536 , P = 0.001 ; 24 hours : ( 27.85.6 ) % vs. ( 16.49.5 ) % , t = -5.882 , P = 0.000 ] .


The amount of fluid resuscitation within 6 hours in modified surviving sepsis bundle group increased significantly compared with standard surviving sepsis bundle group ( 3 608715 mL vs. 2 809795 mL , t = -3.865 , P = 0.033 ) .


The amount of fluid resuscitation within 24 , 48 and 72 hours in modified surviving sepsis bundle group was significantly less than that of standard modified surviving sepsis bundle group with the nadir at 72 hours ( 918351 mL vs. 1 805420 mL , t = 5.907 , P = 0.037 ) .


Duration of mechanical ventilation ( 98.420.3 hours vs. 143.329.6 hours , t = 9.766 , P = 0.001 ) and ICU stay ( 7.13.1 days vs. 9.52.5 days , t = 2.993 , P = 0.004 ) were significantly reduced in modified surviving sepsis bundle group compared with standard surviving sepsis bundle group .


The hospital mortality in modified surviving sepsis bundle group was slightly lower than that in standard surviving sepsis bundle group [ 16.7 % ( 7/42 ) vs. 17.5 % ( 7/40 ) , ( 2 ) = 0.010 , P = 0.920 ] .


Modified surviving sepsis bundle treatment according PiCCO can reduce the severity of disease in patients with septic shock , can make more accurately guide fluid resuscitation , and can reduce lung water and duration of mechanical ventilation and ICU stay .


It has great clinical significance .


Identifying the modality and fidelity of simulation that offers the greatest benefit to the learner is critical to Advanced Cardiac Life Support ( ACLS ) training .


Our hypothesis is that participants who receive ACLS training on high-fidelity mannequins will perform better than those trained on low-fidelity mannequins .


The study was performed in the context of an ACLS Initial Provider course for new postgraduate year 1 residents and involved 3 training arms : ( 1 ) low-fidelity , ( 2 ) mid-fidelity , and ( 3 ) high-fidelity .


Educational outcomes were evaluated by written scores , student evaluations of the course , and expert rater reviews of megacode performance .


A convenience sample of 54 subjects was randomized to 1 of the 3 training arms .


All 3 groups significantly improved based on written posttest scores ( P < 0.0001 ) ; however , pretest to posttest improvement among the 3 training arms was not significantly different : low-fidelity = 42.3 ( 95 % CI , 35.7-48 .9 ) ; mid-fidelity = 41.3 ( 95 % CI , 34.7-47 .9 ) ; high-fidelity = 40.8 ( 95 % CI , 34.3-47 .5 ; P = 0.95 ) .


All participants felt the simulator environment was realistic regardless of level of fidelity .


Participants in the high-fidelity group were less likely to feel comfortable in the simulator environment ( P = 0.0045 ) .


Clinical performance as assessed by expert raters ' megacode scores was better for high-fidelity ( 66.3 ) than mid-fidelity ( 60.1 ) ( P = 0.04 ) .


Overall , there was no difference among the 3 groups in test scores or perceived instructor or course quality ; however , subjects trained on high-fidelity mannequins performed better than those trained on mid-fidelity with respect to megacode performance .


Acetazolamide is commonly used to treat idiopathic intracranial hypertension ( IIH ) , but there is insufficient information to establish an evidence base for its use .


To determine whether acetazolamide is beneficial in improving vision when added to a low-sodium weight reduction diet in patients with IIH and mild visual loss .


Multicenter , randomized , double-masked , placebo-controlled study of acetazolamide in 165 participants with IIH and mild visual loss who received a low-sodium weight-reduction diet .


Participants were enrolled at 38 academic and private practice sites in North America from March 2010 to November 2012 and followed up for 6 months ( last visit in June 2013 ) .


All participants met the modified Dandy criteria for IIH and had a perimetric mean deviation ( PMD ) between -2 dB and -7 dB .


The mean age was 29 years and all but 4 participants were women .


Low-sodium weight-reduction diet plus the maximally tolerated dosage of acetazolamide ( up to 4 g/d ) or matching placebo for 6 months .


The planned primary outcome variable was the change in PMD from baseline to month 6 in the most affected eye , as measured by Humphrey Field Analyzer .


Perimetric mean deviation is a measure of global visual field loss ( mean deviation from age-corrected normal values ) , with a range of 2 to -32 dB ; larger negative values indicate greater vision loss .


Secondary outcome variables included changes in papilledema grade , quality of life ( Visual Function Questionnaire 25 [ VFQ-25 ] and 36-Item Short Form Health Survey ) , headache disability , and weight at month 6 .


The mean improvement in PMD was greater with acetazolamide ( 1.43 dB , from -3.53 dB at baseline to -2.10 dB at month 6 ; n = 86 ) than with placebo ( 0.71 dB , from -3.53 dB to -2.82 dB ; n = 79 ) ; the difference was 0.71 dB ( 95 % CI , 0 to 1.43 dB ; P = .050 ) .


Mean improvements in papilledema grade ( acetazolamide : -1.31 , from 2.76 to 1.45 ; placebo : -0.61 , from 2.76 to 2.15 ; treatment effect , -0.70 ; 95 % CI , -0.99 to -0.41 ; P < .001 ) and vision-related quality of life as measured by the National Eye Institute VFQ-25 ( acetazolamide : 8.33 , from 82.97 to 91.30 ; placebo : 1.98 , from 82.97 to 84.95 ; treatment effect , 6.35 ; 95 % CI , 2.22 to 10.47 ; P = .003 ) and its 10-item neuro-ophthalmic supplement ( acetazolamide : 9.82 , from 75.45 to 85.27 ; placebo : 1.59 , from 75.45 to 77.04 ; treatment effect , 8.23 ; 95 % CI , 3.89 to 12.56 ; P < .001 ) were also observed with acetazolamide .


Participants assigned to acetazolamide also experienced a reduction in weight ( acetazolamide : -7.50 kg , from 107.72 kg to 100.22 kg ; placebo : -3.45 kg , from 107.72 kg to 104.27 kg ; treatment effect , -4.05 kg , 95 % CI , -6.27 to -1.83 kg ; P < .001 ) .


In patients with IIH and mild visual loss , the use of acetazolamide with a low-sodium weight-reduction diet compared with diet alone resulted in modest improvement in visual field function .


The clinical importance of this improvement remains to be determined .


clinicaltrials.gov Identifier : NCT01003639 .


A gel containing diclofenac and hyaluronic acid ( DHA ) and photodynamic therapy with methyl aminolaevulinate ( MAL-PDT ) are widely used treatments for actinic keratoses ( AKs ) .


The aim of this single-centre , open-label , prospective , nonsponsored , randomized controlled clinical trial was to compare the treatment results and cost-effectiveness of MAL-PDT and DHA .


Patients with multiple AKs of the face and scalp were randomized to receive MAL-PDT or DHA .


After 90days , the overall complete remission ( CR ) rate of patients and the CR rate of lesions according to thickness score were assessed , and patients and an investigator scored the cosmetic outcome .


In addition , patients scored their overall satisfaction with the treatment .


Patients with CR of all lesions were followed up for 12months .


Two hundred patients with a total of 1674 AKs were enrolled .


The lesion CR rates at 3months were 859 % with MAL-PDT and 518 % with DHA ( P < 00001 ) .


AKs of all thicknesses were significantly more responsive to MAL-PDT .


The patient CR rates at 3months were 68 % with MAL-PDT and 27 % with DHA .


At the 12-month examination , the number of patients with CR reduced to 37 with MAL-PDT and seven with DHA .


Rating of cosmetic outcome was very good or excellent in the vast majority of patients with both treatments .


The analysis of cost-effectiveness showed that the costs per patient with CR at 3months and at 12months are 5667 and 10262 , respectively , with MAL-PDT and 5952 and 22956 , respectively , with DHA .