Whether listening to background music enhances verbal learning performance is still a matter of dispute .


In this study we investigated the influence of vocal and instrumental background music on verbal learning .


226 subjects were randomly assigned to one of five groups ( one control group and 4 experimental groups ) .


All participants were exposed to a verbal learning task .


One group served as control group while the 4 further groups served as experimental groups .


The control group learned without background music while the 4 experimental groups were exposed to vocal or instrumental musical pieces during learning with different subjective intensity and valence .


Thus , we employed 4 music listening conditions ( vocal music with high intensity : VOC_HIGH , vocal music with low intensity : VOC_LOW , instrumental music with high intensity : INST_HIGH , instrumental music with low intensity : INST_LOW ) and one control condition ( CONT ) during which the subjects learned the word lists .


Since it turned out that the high and low intensity groups did not differ in terms of the rated intensity during the main experiment these groups were lumped together .


Thus , we worked with 3 groups : one control group and two groups , which were exposed to background music ( vocal and instrumental ) during verbal learning .


As dependent variable , the number of learned words was used .


Here we measured immediate recall during five learning sessions ( recall 1 - recall 5 ) and delayed recall for 15 minutes ( recall 6 ) and 14 days ( recall 7 ) after the last learning session .


Verbal learning improved during the first 5 recall sessions without any strong difference between the control and experimental groups .


Also the delayed recalls were similar for the three groups .


There was only a trend for attenuated verbal learning for the group passively listened to vocals .


This learning attenuation diminished during the following learning sessions .


The exposure to vocal or instrumental background music during encoding did not influence verbal learning .


We suggest that the participants are easily able to cope with this background stimulation by ignoring this information channel in order to focus on the verbal learning task .


To determine the relationship between abdominal breathing and tear meniscus volume in healthy women , we investigated the change in tear meniscus volume in two groups : normal breathing and abdominal breathing .


We used a crossover experimental model and examined 20 healthy women aged 20-54 years ( mean SD , 32.7 11.1 years ) .


The participants were randomly assigned to one of two groups .


During the first visit , the normal breathing group was subjected to normal breathing for 3 min , whereas the abdominal breathing group was subjected to abdominal breathing ( 4-second inhalation and 6-second exhalation ) for 3 min .


During the second visit , the protocols were swapped between the two groups .


We estimated the R wave to R wave ( R-R ) interval , tear meniscus volume , salivary amylase activity , pulse , and blood pressure before and immediately after , 15 min after , and 30 min after completion of the breathing activity .


After abdominal breathing , compared to that before breathing , the tear meniscus volume increased significantly 15 min after breathing ( P < .01 ) .


Furthermore , systolic blood pressure showed a significant decrease immediately after abdominal breathing ( P < 0.05 ) .


No significant difference was found in the test parameters in the normal breathing group .


Abdominal breathing for 3 minutes increases the tear meniscus volume in healthy women .


Consequently , abdominal breathing may be considered in the treatment of dry eye disease .


Healing tissue of the rotator cuff does not regenerate the native enthesis ; fibrovascular scar tissue is formed instead and this has less favourable biomechanical properties .


The purpose of this study was to determine if the application of adipose tissue-derived stem cells ( ASCs ) could improve biomechanical and histological properties of the repair .


Fifty Sprague-Dawley rats underwent detachment and repair of the supraspinatus tendon , 32 for the biomechanical study and 18 for the histological examination .


Animals were randomised in two groups to receive either a collagen carrier alone ( untreated group ) or the carrier plus 210 ( 6 ) ASCs ( ASCs group ) .


A control group ( suture only ) was also included for the histological examination .


The animals were sacrificed at 2 and 4 weeks for the biomechanical study and at 24 hours , and 1 and 4 weeks for the histological study .


Maximum load failure energy , elastic energy , mechanical deformation , stiffness and absorbed energy were measured .


Immunofluorescence testing was conducted to show the presence of ASCs in the repair area .


There were no differences between the untreated group and the ASCs group in any of the biomechanical variables at the 2 - and 4-week time points .


The mechanical deformation before failure was higher for the ASCs group compared with the untreated group at 2 weeks and 4 weeks ( p = 0.09 ) , as was the absorbed energy ( p = 0.06 ) .


Differences in maximum load to failure between 2 and 4 weeks were significant for the untreated group ( p = 0.04 ) but not for the ASCs group ( p = 0.17 ) .


Histological examination showed less acute inflammation with diminished presence of oedema and neutrophils in the ASCs group .


There were no differences in the orientation of collagen fibres between groups at either time point .


In the ASCs group , collagen was present only at the last time point .


The application of ASCs in a rat rotator cuff repair model did not improve the biomechanical properties of the tendon-to-bone healing .


However , the ASCs group showed less inflammation , which may lead to a more elastic repair and less scarred healing .


The quality of code status discussions ( CSDs ) is suboptimal as physicians often fail to discuss patients ' goals of care and resuscitation outcomes .


We previously demonstrated that internal medicine residents randomized to a communication skills intervention scored higher than controls on a CSD checklist using a standardized patient .


However , the impact of this training on CSD content is unknown .


Compare CSD content between intervention and control residents .


We conducted qualitative analysis of simulated CSDs .


Augmenting a priori codes with constant comparative analysis , we identified key themes associated with resident determination of code status .


We dichotomized each theme as present or absent .


We used chi-square tests to evaluate the association between training and presence of each theme .


Fifty-six residents rotating on the internal medicine service in July 2010 were randomized to intervention ( n = 25 ) or control ( n = 31 ) .


Intervention residents completed CSD skills training ( lectures , deliberate practice , and self-study ) .


Six months later , all 56 residents completed a simulated CSD .


Comparison of key themes identified in CSDs among intervention and controls .


Fifty-one transcripts were recorded and reviewed .


Themes identified included : exploration of patient values/goals , framing code status as a patient decision , discussion of resuscitation outcomes and quality of life , and making a recommendation regarding code status .


Intervention residents were more likely than controls to explore patient values/goals ( p = 0.002 ) and make a recommendation ( p < 0.001 ) ; and less likely to frame the decision as one solely to be made by the patient ( p = 0.01 ) .


Less than one-third of residents discussed resuscitation outcomes or quality of life .


Training positively influenced CSD content in key domains , including exploration of patient values/goals , making a recommendation regarding code status , and not framing code status as solely a patient decision .


However , despite the intervention , residents infrequently discussed resuscitation outcomes and quality of life .


To determine the relationships among traditional and laparoscopic surgical skills , spatial analysis skills , and video gaming proficiency of third-year veterinary students .


Prospective , randomized , controlled study .


A convenience sample of 29 third-year veterinary students .


The students had completed basic surgical skills training with inanimate objects but had no experience with soft tissue , orthopedic , or laparoscopic surgery ; the spatial analysis test ; or the video games that were used in the study .


Scores for traditional surgical , laparoscopic , spatial analysis , and video gaming skills were determined , and associations among these were analyzed by means of Spearman 's rank order correlation coefficient ( rs ) .


A significant positive association ( rs = 0.40 ) was detected between summary scores for video game performance and laparoscopic skills , but not between video game performance and traditional surgical skills scores .


Spatial analysis scores were positively ( rs = 0.30 ) associated with video game performance scores ; however , that result was not significant .


Spatial analysis scores were not significantly associated with laparoscopic surgical skills scores .


Traditional surgical skills scores were not significantly associated with laparoscopic skills or spatial analysis scores .


Results of this study indicated video game performance of third-year veterinary students was predictive of laparoscopic but not traditional surgical skills , suggesting that laparoscopic performance may be improved with video gaming experience .


Additional studies would be required to identify methods for improvement of traditional surgical skills .


Steroids are used for the treatment of laryngitis in vocal performers and other individuals despite the absence of evidence demonstrating their impact on vocal fold inflammation .


Our objective was to examine laryngeal secretion cytokine inflammatory profile changes associated with corticosteroid treatment in a human phonotrauma model .


Prospective , individual , randomized , double-blinded , controlled trial .


Participants included 10 healthy females who were randomized to either treatment with oral hydrocortisone or placebo , each given in three doses over 20 hours after the experimental induction of acute phonotrauma .


Cytokines associated with inflammation and healing ( interleukin [ IL ] -1 , IL-6 , IL-10 ) were measured in laryngeal secretions before and after vocal loading and at 4 and 20 hours after treatment .


Proinflammatory mediators IL-1 and IL-6 were doubled in the controls versus the steroid treatment group at 21 hours following induction of acute vocal fold inflammation .


Anti-inflammatory cytokine IL-10 showed a 6.3-fold increase in the steroid treatment group versus the controls , indicating anti-inflammatory modulation by steroid treatment .


This study provides biologic evidence supporting the use of steroids for acute vocal fold inflammation associated with phonotrauma .


1b .


Vorapaxar , a novel antiplatelet therapy , reduces thrombotic events in patients with a history of myocardial infarction ( MI ) or peripheral artery disease ( PAD ) ; however , because of an increased risk of intracranial hemorrhage , it is contraindicated in patients with a history of stroke .


The aim of this study was to investigate the incidence of new ischemic stroke and subsequent death or intracerebral hemorrhage in patients with MI or PAD and no cerebrovascular disease ( CVD ) treated with vorapaxar .


The TRA 2 P-TIMI 50 ( Trial to Assess the Effects of Vorapaxar in Preventing Heart Attack and Stroke in Patients With Atherosclerosis-Thrombolysis In Myocardial Infarction 50 ) was a randomized , double-blind , placebo-controlled trial of vorapaxar 2.5 mg daily in 26,449 patients with atherosclerosis , stratified by qualifying disease ( MI , PAD , or CVD ) .


A total of 20,170 patients with MI/PAD , but no CVD , were enrolled .


In patients with MI/PAD and no prior stroke or transient ischemic attack , vorapaxar reduced first ischemic stroke ( hazard ratio [ HR ] : 0.57 , 95 % confidence interval [ CI ] : 0.43 to 0.75 ; p < 0.001 ) .


The risk of hemorrhagic conversion after stroke ( HR : 1.19 , 95 % CI : 0.49 to 2.91 ; p = 0.70 ) or death ( HR : 1.09 , 95 % CI : 0.57 to 2.07 ; p = 0.79 ) during follow-up was not significantly increased with vorapaxar in patients who had a new ischemic stroke ( n = 204 ) .


Although hemorrhagic stroke was increased ( HR : 2.79 , 95 % CI : 1.00 to 7.73 ; p = 0.049 ) , overall stroke was significantly reduced ( HR : 0.67 , 95 % CI : 0.52 to 0.87 ; p = 0.002 ) .


Vorapaxar reduces ischemic stroke in patients with MI or PAD and no known CVD .


There does not appear to be a significant increase in the risk of hemorrhagic conversion or death in patients who experienced a first ischemic stroke on vorapaxar .


Although primary hemorrhagic stroke is increased , vorapaxar reduces the total incidence of stroke .


( Trial to Assess the Effects of Vorapaxar ( SCH 530348 ; MK-5348 ) in Preventing Heart Attack and Stroke in Patients With Atherosclerosis [ TRA 2 P-TIMI 50 ] ; NCT00526474 ) .


We designed a randomized , controlled prospective study aimed at comparing efficacy and tolerability of ezetimibe + fenofibrate treatment versus pravastatin monotherapy in dyslipidemic HIV-positive ( HIV + ) patients treated with protease inhibitors ( PIs ) .


We consecutively enrolled 42 HIV + dyslipidemic patients on stable PIs therapy ( LDL cholesterol > 130 mg/dl or triglycerides 200-500 mg/dl with non-HDL cholesterol > 160 mg/dl ) .


After basal evaluation , patients were randomized to a six-month treatment with ezetimibe 10 mg/day + fenofibrate 200 mg/day or with pravastatin 40 mg/day .


Both at the basal evaluation and after the six-month treatment , the patients underwent blood tests for lipid parameters , and muscle and liver enzymes .


At baseline , the two groups ( 21 patients each ) were similar with regards to gender , age , BMI , blood pressure and virologic and metabolic parameters .


After the six-month therapy , total cholesterol , LDL cholesterol and non-HDL cholesterol decreased significantly ( p < 0.01 ) in both groups .


high-density lipoprotein ( HDL ) cholesterol increased ( 44 10 to 53 12 mg/dl , p < 0.005 ) and triglycerides decreased ( from 265 118 mg/dl to 149 37 mg/dl , p < 0.001 ) in the ezetimibe + fenofibrate group , whereas both parameters remained unchanged in the pravastatin group .


Mean values of creatine kinase ( CK ) , alanine aminotransferase and aspartate aminotransferase were unchanged in both groups ; only one patient in the pravastatin group stopped the treatment after two months , due to increased CK .


In dyslipidemic HIV + patients on PI therapy , the association of ezetimibe + fenofibrate is more effective than pravastatin monotherapy in improving lipid profile and is also well tolerated .


Modified ultrafiltration is used to ameliorate the deleterious effects of cardiopulmonary bypass in pediatric cardiac surgery patients .


The ideal duration of modified ultrafiltration has not been established yet .


We investigated the effects of extended duration of modified ultrafiltration on pulmonary functions and hemodynamics in the early postoperative period in newborns and infants who had transposition of great arteries operations .


Single-center prospective randomized study .


Pediatric cardiac surgery operating room and ICU .


Sixty newborns and infants who had been scheduled to undergo transposition of great arteries operation .


None .


Modified ultrafiltration was applied to all patients following the termination of cardiopulmonary bypass ( for 10 , 15 , and 20 min in groups 1 , 2 , and 3 , respectively ) .


Pulmonary compliance , gas exchange capacity , hemodynamic measurements , inotropic support , blood loss , transfusion requirements , hematocrit level , and duration of ventilatory support were measured after intubation , at termination of cardiopulmonary bypass , at the end of modified ultrafiltration , and in the 1st , 6th , 12th , and 24th hours after admission to ICU .


The amount of fluid removed by modified ultrafiltration in groups 2 and 3 was larger than that of group 1 ( p < 0.01 ) .


Systolic blood pressure was significantly increased at the end of modified ultrafiltration in group 3 compared to groups 1 and 2 ( p < 0.05 ) .


Hematocrit levels were significantly increased at the end of modified ultrafiltration in groups 2 and 3 compared to group 1 ( p < 0.01 ) .


Therefore , RBCs were transfused less after modified ultrafiltration in groups 2 and 3 compared to group 1 ( p < 0.05 ) .


Static and dynamic compliance , oxygen index , and ventilation index had improved similarly in all three groups at the end of modified ultrafiltration ( p > 0.05 ) CONCLUSIONS : : Modified ultrafiltration acutely improved pulmonary compliance and gas exchange in all groups .


Increased hematocrit and blood pressure levels were also observed in the longer modified ultrafiltration group .


However , extended duration of modified ultrafiltration did not have a significant impact on duration of intubation or the stay in ICU .


18F-Sodium fluoride ( 18F-NaF ) and 18F-fluorodeoxyglucose ( 18F-FDG ) are promising novel biomarkers of disease activity in aortic stenosis .


We compared 18F-NaF and 18F-FDG uptake with histological characterization of the aortic valve and assessed whether they predicted disease progression .


Thirty patients with aortic stenosis underwent combined positron emission and computed tomography using 18F-NaF and 18F-FDG radiotracers .


In 12 patients undergoing aortic valve replacement surgery ( 10 for each tracer ) , radiotracer uptake ( mean tissue /


= 0.65 ; P = 0.04 ) and osteocalcin ( r = 0.68 ; P = 0.03 ) immunohistochemistry .


There was no significant correlation between 18F-FDG uptake and CD68 staining ( r = -0.43 ; P = 0.22 ) .


After 1 year , aortic valve calcification increased from 314 ( 193-540 ) to 365 ( 207-934 ) AU ( P < 0.01 ) .


Baseline 18F-NaF uptake correlated closely with the change in calcium score ( r = 0.66 ; P < 0.01 ) , and this improved further ( r = 0.75 ; P < 0.01 ) when 18F-NaF uptake overlying computed tomography-defined macrocalcification was excluded .


No significant correlation was noted between valvular 18F-FDG uptake and change in calcium score ( r = -0.11 ; P = 0.66 ) .


18F-NaF uptake identifies active tissue calcification and predicts disease progression in patients with calcific aortic stenosis .


URL : http://www.clinicaltrials.gov .


Unique identifier : NCT01358513 .


Major depressive disorder is highly prevalent among Latinos with limited English language proficiency in the United States .


Although major depressive disorder is highly treatable , barriers to depression treatment have historically prevented Latinos with limited English language proficiency from accessing effective interventions .


The project seeks to evaluate the efficacy of behavioral activation treatment for depression , an empirically supported treatment for depression , as an intervention that may address some of the disparities surrounding the receipt of efficacious mental health care for this population .


Following a pilot study of behavioral activation treatment for depression with 10 participants which yielded very promising results , the current study is a randomized control trial testing behavioral activation treatment for depression versus a supportive counseling treatment for depression .


We are in the process of recruiting 60 Latinos with limited English language proficiency meeting criteria for major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders 4th and 5th Edition for participation in a single-center efficacy trial .


Participants are randomized to receive 10 sessions of behavioral activation treatment for depression ( n = 30 ) or 10 sessions of supportive counseling ( n = 30 ) .


Assessments occur prior to each session and at 1 month after completing treatment .


Intervention targets include depressive symptomatology and the proposed mechanisms of behavioral activation treatment for depression : activity level and environmental reward .


We will also examine other factors related to treatment outcome such as treatment adherence , treatment satisfaction , and therapeutic alliance .


This randomized controlled trial will allow us to determine the efficacy of behavioral activation treatment for depression in a fast-growing , yet highly underserved population in US mental health services .


The study is also among the first to examine the effect of the proposed mechanisms of change of behavioral activation treatment for depression ( that is , activity level and environmental reward ) on depression over time .


To our knowledge , this is the first randomized controlled trial to compare an empirical-supported treatment to a control supportive counseling condition in a sample of depressed , Spanish-speaking Latinos in the United States .


Clinical Trials Register : NCT01958840 ; registered 8 October 2013 .


Effects on the atrial fibrillatory rate ( AFR ) were studied during infusion with the combined potassium and sodium channel blocker AZD7009 .


Patients with persistent atrial fibrillation ( AF ) were randomized to AZD7009 or placebo .


Thirty-five patients converted to sinus rhythm ( SR ) and were matched to 35 non-converters .


The mean AFR before conversion was 231 fibrillations per minute ( fpm ) , having decreased by 41 % ; in non-converters , it was 296 fpm at the end of infusion , having decreased by 26 % .


The rate of decrease was greater in converters at 5 min , -88 vs. -66 fpm ( p = 0.02 ) , and at 10 min , -133 vs. -111 fpm ( p = 0.048 ) .


The AFR-SD and the exponential decay decreased .


A small left atrial area was the only baseline predictor of conversion to SR. .


AZD7009 produced a significantly more rapid decrease of the AFR in converters than in non-converters , but the AFR at baseline was not predictive of conversion .


We examined the cost-effectiveness of extended smoking cessation treatment in older smokers .


Participants who completed a 12-week smoking cessation program were factorial randomized to extended cognitive behavioral treatment and extended nicotine replacement therapy .


A free-standing smoking cessation clinic .


A total of 402 smokers aged 50 years and older were recruited from the community .


The trial measured biochemically verified abstinence from cigarettes after 2 years and the quantity of smoking cessation services utilized .


Trial findings were combined with literature on changes in smoking status and the age - and gender-adjusted effect of smoking on health-care cost , mortality and quality of life over the long term in a Markov model of cost-effectiveness over a lifetime horizon .


The addition of extended cognitive behavioral therapy added $ 83 in smoking cessation services cost [ P = 0.012 , confidence interval ( CI ) = $ 22-212 ] .


At the end of follow-up , cigarette abstinence rates were 50.0 % with extended cognitive behavioral therapy and 37.2 % without this therapy ( P < 0.05 , odds ratio 1.69 , CI 1.18-2 .54 ) .


The model-based incremental cost-effectiveness ratio was $ 6324 per quality-adjusted life year ( QALY ) .


Probabilistic sensitivity analysis found that the additional $ 947 in lifetime cost of the intervention had a 95 % confidence interval of - $ 331 to 2081 ; the 0.15 additional QALYs had a confidence interval of 0.035-0 .280 , and that the intervention was cost-effective against a $ 50000/QALY acceptance criterion in 99.6 % of the replicates .


Extended nicotine replacement therapy was not cost-effective .


Adding extended cognitive behavior therapy to standard cessation treatment was cost-effective .


Further intensification of treatment may be warranted .


The diagnosis of childhood pulmonary tuberculosis remains a challenge .


The effectiveness of the Keith Edwards scoring system used to diagnose tuberculosis is controversial .


We evaluated this scoring system in the present study .


A prospective randomized study was conducted between March 2008 and December 2011 at the Kimpese General Evangelical Hospital in the Democratic Republic of Congo .


The results of the Keith Edwards score were considered for the 161 children ( 100 pulmonary tuberculosis and 61 case controls ) who were enrolled in the study .


The association between different parameters and the score and between these parameters and pulmonary tuberculosis were statistically analyzed using univariate and multivariate tests .


Eighty-five ( 85 % ) out of the 100 children diagnosed as having pulmonary tuberculosis and 20 ( 32.8 % ) of the case controls had a positive score .


The age of the patient , duration of the disease , nutritional status , tuberculosis contact , positive tuberculin skin test , and lymph node enlargement showed a significant statistical association with the score and pulmonary tuberculosis ( P < 0.05 ) .


The score 's sensitivity and specificity were 85 % and 67.2 % , respectively .


The positive predictive value and negative predictive value were found to be 80.9 % and 73.2 % , respectively .


The positive likelihood ratio was 2.57 , the negative likelihood ratio was 0.22 , and overall agreement was 76.1 % .


The Keith Edwards score could be good tool for public health purposes , but it might be less effective for individual diagnosis of childhood pulmonary tuberculosis because of low specificity .


Further studies are required to evaluate and validate the diagnostic value of clinical and radiological symptoms in childhood pulmonary tuberculosis .


To assess lesion detection and diagnostic confidence of computed tomography ( CT ) of the chest performed at less than 1 mSv with 2 iterative reconstruction ( IR ) techniques .


Ten patients gave written informed consent for the acquisitions of images at submillisievert dose ( 0.9 mSv ) , in addition to clinical standard-dose ( SD ) chest CT ( 2.9 mSv ) .


Submillisievert images were reconstructed with iDose and iterative model reconstruction ( IMR ) .


Two radiologists assessed lesion detection , margins , diagnostic confidence , and visibility of small structures .


Objective noise and noise spectral density were measured .


Lesion detection was identical for standard-dose filtered back projection ( FBP ) , submSv iDose , and submSv IMR .


Lesion margins were better seen for 30 % of detected lung lesions with submSv IMR compared to standard-dose FBP and submSv iDose ( P < 0.05 ) .


Visibility of abdominal structures , and diagnostic confidence with submSv iDose and submSv IMR were similar to standard-dose FBP .


There was 21 % to 64 % noise reduction with submSv IMR and 1 % to 15 % higher noise with iDose compared to standard-dose FBP ( P < 0.0001 ) .


Submillisievert IMR improves delineation of lesion margins compared to standard-dose FBP and submSv iDose .


The effects of glucose-and-fructose ( GF ) coingestion on cycling time trial ( TT ) performance and physiological responses to exercise were examined under postprandial conditions .


Eight trained male cyclists ( age , 25 6 yr ; height , 180 4 cm ; weight , 77 9 kg ; VO2max , 62 6 mLkgmin ) completed the study .


Subjects ingested either an artificially sweetened placebo ( PL ) , a moderate-glucose beverage ( MG , 1.03 gmin ) , a high-glucose beverage ( HG , 1.55 gmin ) , or a GF beverage ( 1.55 gmin , 2:1 ratio ) during approximately 3 h of exercise , including 2 h of constant-load cycling ( 55 % Wmax , 195 17 W ) , immediately followed by a computer-simulated 30-km TT .


Physiological responses ( VE , VO2 , RER , HR , blood glucose level , blood lactate level , and RPE ) and incidences of gastrointestinal distress were assessed during early ( 15-20 min ) , middle ( 55-60 min ) , and late exercise ( 115-120 min ) and during the TT .


Magnitude-based qualitative inferences were used to evaluate differences between treatments .


In comparison with that in PL ( 52.9 3.7 min ) , TT performances were faster with GF ( 50.4 2.2 min , `` very likely '' benefit ) , MG ( 51.1 2.4 min , `` likely '' benefit ) , and HG ( 52.0 3.7 min , `` possible '' benefit ) .


GF resulted in a `` likely '' improvement versus HG ( 3.0 % ) and an `` unclear '' effect relative to MG ( 1.2 % ) .


MG was `` possibly '' beneficial versus HG ( 1.8 % ) .


Few incidences of GI distress were reported in any trials .


GF ingestion seems to enhance performance , relative to PL and HG .


However , it is unclear whether GF improves performance versus moderate doses of glucose .


To observe the impacts of the acupoint catgut implantation on postpartum pain of uterine contraction with qi and blood deficiency .


One hundred and ten primiparas of natural delivery differentiated as qi and blood deficiency pattern in TCM were selected as the subjects .


They were randomized into an acupoint catgut implantation group ( 55 cases ) and a routine nursing group ( 55 cases ) .


In the acupoint catgut implantation group , the catgut was implanted in Zigong ( EX-CA 1 ) , Zusanli ( ST 36 ) , Sanyinjiao ( SP 6 ) , Pishu ( BL 20 ) and Geshu ( BL 17 ) in 6 h after delivery ; additionally , the routine post-delivery nursing was adopted .


In the routine nursing group , the routine post-delivery nursing was applied simply .


Visual analogue scale ( VAS ) and the pain relief time of uterine contraction were compared in 24 h , 48 h , 72 h and 96 h after acupoint catgut implantation between the two groups .


VAS Scores in 24 h , 48 h , 72 h and 96 h after acupoint catgut implantation in the acupoint catgut implantation group were lower apparently than those in the routine nursing group ( 3.31 + / - 0.39 vs 4.31 + / - 0.29 , 1.86 + / - 0.29 vs 2.66 + / - 0.25 , 0.89 + / - 0.21 vs 1.59 + / - 0.24 , 0.35 + / - 0.10 vs 0.69 + / - 0.13 , all P < 0.05 ) .


The pain relief was achieved in ( 72.06 + / - 6.83 ) h in the acupoint catgut implantation group and was ( 123.42 + / - 11.12 ) h in the routine nursing group .


The pain relief in the acupoint catgut implantation group was achieved more quickly ( P < 0.01 ) .


The intervention of acupoint catgut implantation in 6 h after natural delivery in primiparas prevents effectively postpartum pain of uterine contraction .


The cosmetic appearance of a facial scar is a concern for patients undergoing Mohs micrographic surgery ( MMS ) .


Although suturing technique may influence scar cosmesis , few studies have been published comparing suturing methods for MMS repair .


To compare the cosmetic appearance of facial MMS scars sutured with either continuous or interrupted percutaneous nylon sutures .


Patients with facial MMS defects were randomized to have half their scar sutured with interrupted 5-0 nylon stitches , whereas the other half of the scar was closed with running 5-0 nylon stitches .


The appearance of each half of the scar was assessed at 1 week , 8 weeks , and 6 months by the principal investigator .


Blinded photographic evaluation at 1 week and 6 months was completed by a plastic surgeon and general dermatologist .


A total of 105 patients were entered into the trial , and 101 completed all time point assessments .


There was no statistically significant difference in scar outcome using each of the 3 scar assessment scales , at any time point , for any assessor ( blinded and nonblinded ) .


Interrupted and continuous 5-0 nylon sutures result in an equivalent final cosmetic appearance of facial MMS scars .


Given its advantages , running sutures may be the preferred closure technique for facial repair .


The German Society of Radiation Oncology initiated a multicenter trial to evaluate core processes and subprocesses of radiotherapy by prospective evaluation of all important procedures in the most frequent malignancies treated by radiation therapy .


The aim of this analysis was to assess the required resources for interstitial high-dose-rate ( HDR ) and low-dose-rate ( LDR ) prostate brachytherapy ( BRT ) based on actual time measurements regarding allocation of personnel and room occupation needed for specific procedures .


Two radiotherapy centers ( community hospital of Offenbach am Main and community hospital of Eschweiler ) participated in this prospective study .


Working time of the different occupational groups and room occupancies for the workflow of prostate BRT were recorded and methodically assessed during a 3-month period .


For HDR and LDR BRT , a total of 560 and 92 measurements , respectively , were documented .


The time needed for treatment preplanning was median 24min for HDR ( n = 112 measurements ) and 6min for LDR BRT ( n = 21 ) .


Catheter implantation with intraoperative HDR real-time planning ( n = 112 ) , postimplantation HDR treatment planning ( n = 112 ) , and remotely controlled HDR afterloading irradiation ( n = 112 ) required median 25 , 39 , and 50min , respectively .


For LDR real-time planning ( n = 39 ) and LDR treatment postplanning ( n = 32 ) , the assessed median duration was 91 and 11min , respectively .


Room occupancy and overall mean medical staff times were 194 and 910min respectively , for HDR , and 113 and 371min , respectively , for LDR BRT .


In this prospective analysis , the resource requirements for the application of HDR and LDR BRT of prostate cancer were assessed methodically and are presented for first time .


Management of ureteral stones remains controversial .


To determine whether optimizing the extracorporeal shock wave lithotripsy delivery rate would improve the treatment of solitary ureteral stones we compared the outcomes of 2 delivery rates in a prospective randomized trial .


From July 2010 to October 2012 , 254 consecutive patients were randomized to extracorporeal shock wave lithotripsy at a shock wave delivery rate of 60 and 90 pulses per minute in 130 and 124 , respectively .


The primary study end point was the stone-free rate at 3-month followup .


Secondary end points were stone disintegration , treatment time , complications and the rate of secondary treatments .


Descriptive statistics were used to compare end points between the 2 groups .


The adjusted OR and 95 % CI were calculated to assess predictors of success .


The stone-free rate at 3 months was significantly higher in patients who underwent extracorporeal shock wave lithotripsy at a shock wave delivery rate of 90 pulses per minute than in those who received 60 pulses per minute ( 91 % vs 80 % , p = 0.01 ) .


Patients with proximal ( 100 % vs 83 % , p = 0.005 ) and mid ureteral stones ( 96 % vs 73 % , p = 0.03 ) accounted for the observed difference but not those with distal ureteral stones ( 81 % vs 80 % , p = 0.9 , respectively ) .


Treatment time , complications and the rate of secondary treatments were comparable between the 2 groups .


On multivariable analysis the shock wave delivery rate of 90 pulses per minute , proximal stone location , stone density , stone size and an absent indwelling Double-J stent were independent predictors of success .


Optimizing the extracorporeal shock wave lithotripsy delivery rate can achieve excellent results for ureteral stones .


To examine penile vibratory stimulation ( PVS ) in the treatment of post-prostatectomy urinary incontinence ( UI ) .


Patients with post-prostatectomy UI were included in a 12-week trial .


A 24-hr pad test and a 72-hr voiding diary were collected at baseline .


Participants were randomized to receive PVS for the first 6 weeks ( group 1 ) or for the final 6 weeks ( group 2 ) of the study .


The primary outcome was the difference in leakage between groups 1 and 2 at 6 weeks as measured by changes in the pad test .


The trial was registered at www.clinicaltrials.org ( NCT01540656 ) .


Data from 31 men were available for analyses .


The difference in the change on the pad test between the groups did not reach statistical significance at 6 weeks ( P = 0.13 ) while the change in incontinence episodes between groups approached statistical significance ( P = 0.052 ) .


However , there was a median reduction of -33 g ( P = 0.021 ) on the pad test and a median reduction in daily incontinence episodes of -1 ( P = 0.023 ) in group 1 at 6 weeks .


At 12 weeks , group 2 had a median decrease on the pad test of -8 g ( P = 0.10 ) and no change in incontinence episodes .


A pooled analysis showed a decline on the pad test of -13.5 g ( P = 0.004 ) after PVS .


Small improvements were seen in subjective symptom scores and 58 % stated to be satisfied with PVS .


Self-limiting side effects were experienced by 15 % of patients .


PVS is feasible in the treatment of post-prostatectomy UI .


Larger trials are needed to document the clinical efficacy .


No five-year long-term follow-up data is available regarding the prognostic value of GDF-15 .


Our aim is to evaluate the long-term prognostic value of admission growth-differentiation factor 15 ( GDF-15 ) regarding death or myocardial infarction ( MI ) in patients with non-ST-elevation acute coronary syndrome ( NSTE-ACS ) .


This is a subanalysis from the ICTUS ( Invasive versus Conservative Treatment in Unstable coronary Syndromes ) trial , including troponin positive NSTE-ACS patients .


The main outcome for the current analysis was 5-year death or spontaneous MI .


GDF-15 samples were available in 1151 patients .


The prognostic value of GDF-15 , categorized into < 1200 ng/L , 1200-1800 ng/L and > 1800 ng/L , was assessed in unadjusted and adjusted Cox regression models .


Adjustments were made for identified univariable risk factors .


The additional discriminative and reclassification value of GDF-15 beyond the independent risk factors was assessed by the category-free net reclassification improvement ( 1/2 NRI ( > 0 ) ) and the integrated discrimination improvement ( IDI ) RESULTS : Compared to GDF-15 < 1200 ng/L , a GDF-15 > 1800 ng/L was associated with an increased hazard ratio for death or spontaneous MI , mainly driven by mortality .


GDF-15 levels were predictive after adjustments for other identified predictors .


Additional discriminative value was shown with the IDI , not with the NRI .


In patients presenting with NSTE-ACS and elevated troponin T , GDF-15 provides prognostic information in addition to identified predictors for mortality and spontaneous MI and can be used to identify patients at high risk during long-term follow-up .


Dietary patterns that are considered healthy ( eg , the Dietary Approaches to Stop Hypertension diet and Mediterranean diet ) may be more successful in reducing typical cardiovascular disease risks compared to dietary patterns considered unhealthy ( eg , energy-dense diets such as the typical American diet ) .


This study assessed the effects of a Korean diet , the 2010 Dietary Guidelines for Americans ( DGA ) , and a typical American diet on cardiometabolic risk factors , including lipid levels and blood pressure , in overweight , non-Asian individuals in the United States with elevated low-density lipoprotein cholesterol .


The study was a three-period crossover , controlled-feeding study from January 2012 to May 2012 .


Thirty-one subjects were randomly allocated to one of six possible sequential orders for consuming the three diets for 4 weeks , each separated by a 10-day break .


Data analysis included 27 subjects on the Korean diet periods and 29 in the DGA and typical American diet periods .


Subjects remained weight stable .


Lipid profile , blood pressure , insulin , glucose , and 24-hour urinary sodium were determined at baseline and at the end of each diet period .


The additive main effects multiplicative interactions model was used to test for a subject by diet interaction .


Differences among diets were determined using a mixed-models procedure ( PROC MIXED ) with random intercept for each subject .


Total cholesterol and low-density lipoprotein cholesterol significantly decreased on Korean ( P < 0.0001 and P < 0.01 , respectively ) and DGA ( P < 0.01 and P < 0.05 , respectively ) diets , but not on the typical American diet .


Although an unfavorable outcome , high-density lipoprotein cholesterol significantly decreased on all three diets ( Korean : P < 0.0001 ; DGA : P < 0.0001 ; typical American : P < 0.05 ) .


No diet had a significant effect on serum triglycerides , but a slight increase in triglycerides in the Korean and decrease in the DGA resulted in a significant difference between these two diets ( P < 0.01 ) .


All three diets caused modest decreases in systolic and diastolic blood pressure , which reached statistical significance for DGA only ( P < 0.05 and P < 0.01 , respectively ) .


No diet had significant effect on fasting insulin , whereas fasting glucose decreased significantly on the Korean ( P < 0.01 ) and typical American ( P < 0.05 ) diets only .


Urinary sodium output decreased significantly on DGA ( P < 0.0001 ) .


After a 4-week feeding period , Korean and DGA diet patterns resulted in positive changes in cardiovascular disease risk factors .


The primary outcome results for the SPS3 trial suggested that a lower systolic target blood pressure ( < 130 mm Hg ) might be beneficial for reducing the risk of recurrent stroke compared with a higher target ( 130-149 mm Hg ) , but that the addition of clopidogrel to aspirin was not beneficial compared with aspirin plus placebo .


In this prespecified secondary outcome analysis of the SPS3 trial , we aimed to assess whether blood pressure reduction and dual antiplatelet treatment affect changes in cognitive function over time in patients with cerebral small vessel disease .


In the SPS3 trial , patients with recent ( within 6 months ) symptomatic lacunar infarcts from 81 centres in North America , Latin America , and Spain were randomly assigned , in a two-by-two factorial design , to target levels of systolic blood pressure ( 1:1 ; 130-149 mm Hg vs < 130 mm Hg ; open-label ) and to a once-daily antiplatelet treatment ( 1:1 ; aspirin 325 mg plus clopidogrel 75 mg vs aspirin 325 mg plus placebo ; double-blind ) .


For this analysis , the main cognitive outcome was change in Cognitive Abilities Screening Instrument ( CASI ) during follow-up .


Patients were tested annually for up to 5 years , during which time the mean difference in systolic blood pressure was 11 mm Hg ( SD 16 ) between the two targets ( 138 mm Hg vs 127 mm Hg at 1 year ) .


We used linear mixed models to compare changes in CASI Z scores over time .


The SPS3 trial is registered with ClinicalTrials.gov , number NCT00059306 .


The study took place between March 23 , 2003 , and April 30 , 2012.2916 of 3020 SPS3 participants ( mean age 63 years [ SD 11 ] ) with CASI scores at study entry were included in the analysis , with a median follow-up of 30 years ( IQR 10-49 ) .


Mean changes in CASI Z scores from study entry to assessment at years 1 ( n = 2472 ) , 2 ( n = 1968 ) , 3 ( n = 1521 ) , 4 ( n = 1135 ) , and 5 ( n = 803 ) were 012 ( SD 083 ) , 015 ( 084 ) , 016 ( 095 ) , 019 ( 099 ) , and 014 ( 109 ) , respectively .


Changes in CASI Z scores over time did not differ between assigned antiplatelet groups ( p = 0858 ) or between assigned blood pressure target groups ( p = 0520 ) .


There was no interaction between assigned antiplatelet groups and assigned blood pressure target groups and change over time ( p = 0196 ) .


Cognitive function is not affected by short-term dual antiplatelet treatment or blood pressure reduction in fairly young patients with recent lacunar stroke .


Future studies of cognitive function after stroke should be of longer duration or focus on patients with higher rates of cognitive decline .


US National Institute of Neurological Disorders and Stroke .


Vascular endothelial growth factor C ( VEGFC ) and vascular endothelial growth factor receptor 1 ( VEGFR1 ) mRNA overexpression has recently been shown to have strong predictive and prognostic value in patients with high-risk early breast cancer undergoing adjuvant chemotherapy .


The present study evaluated associations of VEGFC and VEGFR1 with human epidermal growth factor receptor 2 ( HER2 ) and their prognostic value dependent on HER2 status .


RNA was isolated from 298 formalin-fixed paraffin-embedded tumor tissue samples from the HeCOG 10/97 ( HE10/97 ) trial , evaluating adjuvant dose-dense sequential chemotherapy with epirubicin followed by cyclophosphamide , methotrexate and 5-fluorouracil therapy with or without paclitaxel ( E-T-CMF vs. E-CMF ) .


A fully-automated method based on magnetic beads was applied for RNA extraction , followed by one-step quantitative reverse transcription-polymerase chain reaction .


At 13.3 years of median follow-up , 116 patients ( 38.9 % ) had experienced relapse and 115 ( 38.6 % ) had died .


There were strong associations between VEGFC/VEGFR1 mRNA expression and HER2 and estrogen receptor/progesterone receptor status .


In multivariate analysis , both VEGFC and VEGFR1 were found to be associated with risk for death or relapse , but such associations depended on HER2 status and treatment group .


High VEGFC was a negative prognostic factor for disease-free survival [ hazard ratio ( HR ) = 1.79 , 95 % confidence interval ( CI ) = 1.05-3 .05 , Wald 's p = 0.032 ] , with a trend for overall survival ( HR = 1.80 , 95 % CI = 0.94-3 .47 , p = 0.078 ) in patients treated with E-CMF adjusted for clinicopathological characteristics , while high VEGFR1 was associated with increased risk for death , yet non significantly in patients with HER2-negative disease ( HR = 1.51 , 95 % CI = 0.82-2 .77 , p = 0.18 ) , regardless of treatment .


VEGFC and VEGFR1 mRNA overexpression is of prognostic value , dependent on HER2 status , in patients with high-risk early breast cancer undergoing adjuvant treatment .


Among HER2-negative cases , these angiogenic markers could identify more aggressive tumors with worse prognosis .


Further studies are warranted to validate VEGFC and VEGFR1 as potential biomarkers in adjuvant therapy and their use in identifying sub-groups that could benefit from anti-VEGF strategies .


Randomized clinical study .


To compare the effects of trigger point ( TrP ) dry needling ( DN ) and TrP manual therapy ( MT ) on pain , function , pressure pain sensitivity , and cervical range of motion in subjects with chronic mechanical neck pain .


Recent evidence suggests that TrP DN could be effective in the treatment of neck pain .


However , no studies have directly compared the outcomes of TrP DN and TrP MT in this population .


Ninety-four patients ( mean SD age , 31 3 years ; 66 % female ) were randomized into a TrP DN group ( n = 47 ) or a TrP MT group ( n = 47 ) .


Neck pain intensity ( 11-point numeric pain rating scale ) , cervical range of motion , and pressure pain thresholds ( PPTs ) over the spinous process of C7 were measured at baseline , postintervention , and at follow-ups of 1 week and 2 weeks after treatment .


The Spanish version of the Northwick Park Neck Pain Questionnaire was used to measure disability/function at baseline and the 2-week follow-up .


Mixed-model , repeated-measures analyses of variance ( ANOVAs ) were used to determine if a time-by-group interaction existed on the effects of the treatment on each outcome variable , with time as the within-subject variable and group as the between-subject variable .


The ANOVA revealed that participants who received TrP DN had outcomes similar to those who received TrP MT in terms of pain , function , and cervical range of motion .


The 4-by-2 mixed-model ANOVA also revealed a significant time-by-group interaction ( P < .001 ) for PPT : patients who received TrP DN experienced a greater increase in PPT ( decreased pressure sensitivity ) than those who received TrP MT at all follow-up periods ( between-group differences : posttreatment , 59.0 kPa ; 95 % confidence interval [ CI ] : 40.0 , 69.2 ; 1-week follow-up , 69.2 kPa ; 95 % CI : 49.5 , 79.1 ; 2-week follow-up , 78.9 kPa ; 95 % CI : 49.5 , 89.0 ) .


The results of this clinical trial suggest that 2 sessions of TrP DN and TrP MT resulted in similar outcomes in terms of pain , disability , and cervical range of motion .


Those in the TrP DN group experienced greater improvements in PPT over the cervical spine .


Future trials are needed to examine the effects of TrP DN and TrP MT over long-term follow-up periods .


Therapy , level 1b .


To investigate the application of lactic acid in early diagnosis and goal-directed therapy of septic shock , and to provide reference for the early clinical diagnosis and treatment of septic shock .


A prospective observational study was conducted , in which patients satisfied with the criteria of septic shock diagnosis were enrolled .


The patients were randomly divided into two groups .


The lactic group was defined using blood lactic acid concentration < 2 mmol/L as treatment guide target .


Control group was defined according to the traditional diagnostic criteria of shock which systolic blood pressure was less than 90 mmHg ( 1 mmHg = 0.133 kPa ) or systolic blood pressure value fell > 40 mmHg baseline or oliguria ( < 0.5 ml .


kg-1 .


h-1 ) et al traditional septic shock diagnosis criteria and bundle treatment was performed .


Organ dysfunction index , the sequential organ failure score ( SOFA ) , acute physiology and chronic health evaluation score II ( APACHE II ) score , the time of mechanical ventilation , the time of stay in the intensive care unit ( ICU ) , and the 7-and 28-day mortality were recorded .


There were 26 and 31 septic shock patients in lactic group and control group respectively .


Organ dysfunction index had been improved in different degrees after treatment compared with that before treatment .


Creatinine ( Cr ) at 48 hours after treatment in lactic group was significantly lower than that in control group ( mol/L : 94.48 6.68 vs. 107.44 10.35 , P < 0.05 ) , and there was no statistical difference in other indexes .


The SOFA score of lactic group at 24 hours and 48 hours after treatment was lower than that of control group ( 9.27 4.62 vs. 9.79 3.80 , t = 2.103 , P = 0.040 ; 8.54 5.53 vs. 9.70 4.30 , t = 2.302 , P = 0.023 ) .


APACHE II score of two group after treatment were lower than that before treatment , and lactic group decreased more obviously compared with control group ( 14.25 5.29 vs. 20.00 9.74 , t = 2.298 , P = 0.026 ; 13.60 6.18 vs 18.15 6.62 , t = 2.653 , P = 0.011 ) .


The time of stay in the ICU and the time of mechanical ventilation of lactic group were shorter that those of control group , but there was no statistical difference [ ICU time ( days ) : 8.95 5.19 vs. 9.45 6.18 , t = 0.605 , P = 0.652 ; mechanical ventilation time ( hours ) : 101.15 11.50 vs. 110.63 13.26 , t = 0.631 , P = 0.564 ] .


There was no statistical difference regarding 7-day mortality of lactic group was lower than that of control group [ 15.38 % ( 4/26 ) vs. 16.13 % ( 5/31 ) , 2 = 0.000 , P = 1.000 ] .


The 28-day mortality of lactic group was lower than that of control group [ 26.92 % ( 7/26 ) vs. 54.84 % ( 17/31 ) .


2 = 4.520 , P = 0.033 ] .


By blood lactic acid monitoring , inadequacy of organization perfusion i.e. septic shock can be found in the early stage , thus early intervention can be performed and improve resuscitation result and reduce the mortality of septic shock patients .


Blood lactic acid 4 mmol/L can be used as one of the criteria for the diagnosis of septic shock , and 6-hour blood lactic acid < 2 mmol/L as a goal to guide shock treatment with obvious prognosis improvement .


The aim of the present trial on ultrasound ( US ) - guided laser ablation therapy ( LAT ) of solid thyroid nodules is to assess long-term clinical efficacy , side effects , and predictability of outcomes in different centers operating with the same procedure .


Two hundred consecutive patients were randomly assigned to a single LAT session ( group 1 , 101 cases ) or to follow-up ( group 2 , 99 cases ) at four thyroid referral centers .


Entry criteria were : solid thyroid nodule with volume of 6-17 mL , repeat benign cytological findings , normal thyroid function , no autoimmunity , and no thyroid gland treatment .


Group 1 : LAT was performed in a single session with two optical fibers , a 1064 nm Nd-YAG laser source , and an output power of 3 W. Volume and local symptom changes were evaluated 1 , 6 , 12 , 24 , and 36 months after LAT .


Side effects and tolerability of treatment were registered .


Group 2 : Follow-up with no treatment .


One patient was lost to follow-up in each group .


Group 1 : Volume decrease after LAT was -49 22 % , -59 22 % , -60 24 % , and -57 25 % at 6 , 12 , 24 , and 36 months , respectively ( P < .001 vs baseline ) .


LAT resulted in a nodule reduction of > 50 % in 67.3 % of cases ( P < .001 ) .


Local symptoms decreased from 38 to 8 % of cases ( P = .002 ) and cosmetic signs from 72 to 16 % of cases ( P = .001 ) .


Baseline size , presence of goiter ( P = .55 ) , or US findings ( fluid component 20 % [ P = .84 ] , halo [ P = .46 ] , vascularization [ P = .98 ] , and calcifications [ P = .06 ] ) were not predictive factors of a volume decrease > 50 % .


The procedure was well tolerated in most ( 92 % ) cases .


No changes in thyroid function or autoimmunity were observed .


In group 2 , nodule volume increased at 36 months ( 25 42 % ; P = .04 ) .


The efficacy and tolerability of the procedure were similar in different centers .


A single LAT treatment of solid nodules results in significant and persistent volume reduction and local symptom improvement , in the absence of thyroid function changes .


Live attenuated influenza vaccines ( LAIVs ) are being developed to protect humans against future epidemics and pandemics .


This study describes the results of a double-blinded randomized placebo-controlled phase I clinical trial of cold-adapted and temperature sensitive H7N3 live attenuated influenza vaccine candidate in healthy seronegative adults .


The goal of the study was to evaluate the safety , tolerability , immunogenicity and potential shedding and transmission of H7N3 LAIV against H7 avian influenza virus of pandemic potential .


Two doses of H7N3 LAIV or placebo were administered to 40 randomly divided subjects ( 30 received vaccine and 10 placebo ) .


The presence of influenza A virus RNA in nasal swabs was detected in 60.0 % and 51.7 % of subjects after the first and second vaccination , respectively .


In addition , vaccine virus was not detected among placebo recipients demonstrating the absence of person-to-person transmission .


The H7N3 live attenuated influenza vaccine demonstrated a good safety profile and was well tolerated .


The two-dose immunization resulted in measurable serum and local antibody production and in generation of antigen-specific CD4 and CD8 memory T cells .


Composite analysis of the immune response which included hemagglutinin inhibition assay , microneutralization tests , and measures of IgG and IgA and virus-specific T cells showed that the majority ( 86.2 % ) of vaccine recipients developed serum and/or local antibodies responses and generated CD4 and CD8 memory T cells .


The H7N3 LAIV was safe and well tolerated , immunogenic in healthy seronegative adults and elicited production of antibodies broadly reactive against the newly emerged H7N9 avian influenza virus .


ClinicalTrials.gov NCT01511419 .


Galectin-3 ( Gal-3 ) is a marker of myocardial fibrosis , and elevated levels are associated with adverse outcomes .


Mineralocorticoid receptor antagonists ( MRAs ) modulate cardiac fibrosis in heart failure ( HF ) patients and have been shown to improve long-term outcomes .


We examined whether treatment effects from MRA use differed by Gal-3 levels in ambulatory heart failure patients enrolled in HF-ACTION .


HF-ACTION was a randomized controlled trial of exercise training versus usual care in patients with HF due to LV systolic dysfunction ( New York Heart Association functional class II-IV , left ventricular ejection fraction 0.35 , median follow-up 2.5 years ) .


Galectin-3 was assessed at baseline in 895 patients .


The end point was all-cause mortality or all-cause hospitalization ( ACM+ACH ) ; all-cause mortality ( ACM ) was a key secondary end point .


A differential association of MRA use by increasing Gal-3 concentration was tested with the use of interaction terms in Cox proportional hazards models , adjusted for covariates previously identified in this cohort as well as age , sex , and race .


Inverse propensity-weighted ( IPW ) methods were also used to assess this association .


Approximately one-half ( n = 401 ) of the patients were on an MRA .


There was no significant interaction for the associations of Gal-3 levels and MRA use for either end point ( adjusted interaction P = .76 for ACM+ACH ; P = .26 for ACM ) .


There was no evidence of improved outcomes for patients on an MRA compared with those not on MRA for either end point ( hazard ratio [ HR ] 1.02 , 95 % confidence interval [ CI ] 0.85-1 .23 , P = .8 ; and HR = 1.15 , 95 % CI [ 0.82-1 .61 ] , P = .4 ; respectively ) .


IPW analysis was consistent with the results of the adjusted analysis .


Our study showed no evidence of interaction between Gal-3 and treatment effect of MRA .


Whether biomarkers may be used to predict which patients may benefit from an mineralocorticoid receptor antagonist in HF requires further investigation .


This study investigated the effects of written emotional disclosure on a model of chronic pain in healthy women with and without trauma history .


Participants were prescreened for their trauma history ( N = 78 ) and randomized to a disclosure or a control writing condition .


Pain testing occurred either 1 day or 1 month after disclosure .


Capsaicin was applied to the forearm to evoke spontaneous burning pain at the application site and mechanical secondary hyperalgesia in the surrounding untreated skin .


As hypothesized , the effect of disclosure on the area and intensity of secondary hyperalgesia depended on trauma history and time of testing ( F ( 1,69 ) 7.37 , p = .008 ) .


Disclosure increased secondary hyperalgesia in participants with trauma history compared with those without trauma when testing occurred 1 day after writing ( F ( 1,69 ) 5.27 , p .025 ) , whereas the opposite pattern was observed 1 month later ( F ( 1,69 ) 4.88 , p .031 ) .


Of the participants with trauma history in the disclosure condition , secondary hyperalgesia was reduced at 1 month compared with 1 day after writing ( p = .001 ) .


Moreover , greater use of positive emotional words predicted reduced secondary hyperalgesia at 1 month ( = -0.71 , p = .022 ) .


In contrast , disclosure had no effect on spontaneous pain .


Disclosure modulates secondary hyperalgesia observed in women with trauma history , producing a short-term enhancement and a long-term reduction .


This suggests that disclosure has a long-term protective effect that reduces sensitization of pain , which may explain the therapeutic effects of disclosure in patients with chronic pain .


With recent progress in health science administration , a huge amount of data has been collected from thousands of subjects .


Statistical and computational techniques are very necessary to understand such data and to make valid scientific conclusions .


The purpose of this paper was to develop a statistical probability model and to predict future survival times for male breast cancer patients who were diagnosed in the USA during 1973-2009 .


A random sample of 500 male patients was selected from the Surveillance Epidemiology and End Results ( SEER ) database .


The survival times for the male patients were used to derive the statistical probability model .


To measure the goodness of fit tests , the model building criterions : Akaike Information Criteria ( AIC ) , Bayesian Information Criteria ( BIC ) , and Deviance Information Criteria ( DIC ) were employed .


A novel Bayesian method was used to derive the posterior density function for the parameters and the predictive inference for future survival times from the exponentiated Weibull model , assuming that the observed breast cancer survival data follow such type of model .


The Markov chain Monte Carlo method was used to determine the inference for the parameters .


The summary results of certain demographic and socio-economic variables are reported .


It was found that the exponentiated Weibull model fits the male survival data .


Statistical inferences of the posterior parameters are presented .


Mean predictive survival times , 95 % predictive intervals , predictive skewness and kurtosis were obtained .


The findings will hopefully be useful in treatment planning , healthcare resource allocation , and may motivate future research on breast cancer related survival issues .


The effect of levosimendan on renal function in patients with low ejection fraction undergoing mitral valve surgery was investigated .


A prospective , double-blinded , randomized clinical trial .


Tertiary teaching and research hospital .


Of a total of 147 patients , 128 patients completed the study .


In the levosimendan group ( n = 64 ) , levosimendan was administered in addition to standard inotropic support ; whereas , in the control group ( n = 64 ) , only standard inotropic support was given .


In the levosimendan group , a loading dose of levosimendan ( 6 g/kg ) was administered after removal of the aortic cross-clamp , followed by an infusion ( 0.1 g/kg/min ) in addition to standard inotropic therapy for 24 hours .


In the control group , only standard inotropic therapy was administered .


Preoperative characteristics , serum creatinine ( sCr ) levels , and estimated glomerular filtration rate ( eGFR ) were determined preoperatively , on postoperative days 1 , 3 , and 10 .


Independent risk factors for renal replacement therapy ( RRT ) requirement were investigated with stepwise multivariate logistic regression analysis .


The primary endpoint was the effect of levosimendan on postoperative renal clearance ( sCr and eGFR ) .


The secondary endpoint was the effect of levosimendan on clinical outcomes ( length of intensive care unit and hospital stays , need for RRT ) .


Preoperative characteristics and eGFR were similar between the groups ( p > 0.05 ) .


On postoperative days 1 and 3 , sCr values were lower and eGFR values were higher in the levosimendan group in comparison with the control group ( p = 0.0001 , p = 0.009 , respectively ) .


Six patients ( 9.4 % ) in the levosimendan group and 10 patients ( 15.6 % ) in the control group required RRT therapy ( p = 0.284 ) .


Independent risk factors for need of RRT include preoperative sCr value between 1.2 to 2.09 mg/dL and2 .1 mg/dL ( p < 0.05 ) .


Perioperative treatment with levosimendan in addition to standard inotropic therapy in patients with a low ejection fraction undergoing mitral valve surgery improved immediate postoperative renal function and reduced need for RRT .


We have previously reported that radiotherapy ( RT ) added to androgen-deprivation therapy ( ADT ) improves survival in men with locally advanced prostate cancer .


Here , we report the prespecified final analysis of this randomized trial .


NCIC Clinical Trials Group PR .3 / Medical Research Council PR07/Intergroup T94-0110 was a randomized controlled trial of patients with locally advanced prostate cancer .


Patients with T3-4 , N0/Nx , M0 prostate cancer or T1-2 disease with either prostate-specific antigen ( PSA ) of more than 40 g/L or PSA of 20 to 40 g/L plus Gleason score of 8 to 10 were randomly assigned to lifelong ADT alone or to ADT+RT .


The RT dose was 64 to 69 Gy in 35 to 39 fractions to the prostate and pelvis or prostate alone .


Overall survival was compared using a log-rank test stratified for prespecified variables .


One thousand two hundred five patients were randomly assigned between 1995 and 2005 , 602 to ADT alone and 603 to ADT+RT .


At a median follow-up time of 8 years , 465 patients had died , including 199 patients from prostate cancer .


Overall survival was significantly improved in the patients allocated to ADT+RT ( hazard ratio [ HR ] , 0.70 ; 95 % CI , 0.57 to 0.85 ; P < .001 ) .


Deaths from prostate cancer were significantly reduced by the addition of RT to ADT ( HR , 0.46 ; 95 % CI , 0.34 to 0.61 ; P < .001 ) .


Patients on ADT+RT reported a higher frequency of adverse events related to bowel toxicity , but only two of 589 patients had grade 3 or greater diarrhea at 24 months after RT. .


This analysis demonstrates that the previously reported benefit in survival is maintained at a median follow-up of 8 years and firmly establishes the role of RT in the treatment of men with locally advanced prostate cancer .


Smoking prevalence rates among Dutch children increase rapidly after they transit to secondary school , in particular among children with a low socioeconomic status ( SES ) .


Web-based , computer-tailored programs supplemented with prompt messages may be able to empower children to prevent them from starting to smoke when they transit to secondary school .


The main aim of this study is to evaluate whether computer-tailored feedback messages , with and without prompt messages , are effective in decreasing children 's smoking intentions and smoking behavior after 12 and 25 months of follow-up .


Data were gathered at baseline ( T0 ) , and after 12 months ( T1 ) and 25 months ( T2 ) of follow-up of a smoking prevention intervention program called Fun without Smokes .


A total of 162 schools were randomly allocated to a no-intervention control group , an intervention prompt group , or an intervention no-prompt group .


A total of 3213 children aged 10 to 12 years old participated in the study and completed a Web-based questionnaire assessing their smoking intention , smoking behavior , and sociocognitive factors , such as attitude , social influence , and self-efficacy , related to smoking .


After completion , children in the intervention groups received computer-tailored feedback messages in their own email inbox and those messages could be accessed on the intervention website .


Children in the prompt group received prompt messages , via email and short message service ( SMS ) text messaging , to stimulate them to reuse the intervention website with nonsmoking content .


Multilevel logistic regression analyses were performed using multiple imputations to assess the program effects on smoking intention and smoking behavior at T1 and T2 .


A total of 3213 children participated in the Fun without Smokes study at T0 .


Between T0 and T1 a total of 1067 children out of the original 3213 ( 33.21 % ) dropped out of the study .


Between T0 and T2 the number of children that did not participate in the final measurement was 1730 out of the original 3213 ( 53.84 % ) .


No significant program effects were observed for any of the intervention groups compared to the control group at T1 for the intention to engage in smoking-prompt , OR 0.67 ( 95 % CI 0.30-1 .50 ) , no-prompt , OR 0.76 ( 95 % CI 0.34-1 .67 ) - or for smoking behavior-prompt , OR 1.13 ( 95 % CI 0.13-9 .98 ) , no-prompt , OR 0.50 ( 95 % CI 0.04-5 .59 ) .


Similar nonsignificant program effects were found at T2 for the intention to start smoking-prompt , OR 0.78 ( 95 % CI 0.26-2 .32 ) , no-prompt , OR 1.31 ( 95 % CI 0.45-3 .82 ) - and smoking behavior-prompt , OR 0.53 ( 95 % CI 0.12-2 .47 ) , no-prompt , OR 1.01 ( 95 % CI 0.24-4 .21 ) .


This study showed that the Web-based , computer-tailored feedback messages with and without prompt messages were not effective in modifying children 's smoking intentions and smoking behavior as compared to no information .


Future smoking prevention interventions are recommended to start closer to the age of actual smoking uptake .


Furthermore , future studies on Web-based , computer-tailored smoking prevention programs should focus on assessing and controlling exposure to the educational content and the response to the prompt messages .


Netherlands Trial Register NTR3116 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3116 ( Archived by WebCite at http://www.webcitation.org/6O0wQYuPI ) .


Routine resection of cavity shave margins ( additional tissue circumferentially around the cavity left by partial mastectomy ) may reduce the rates of positive margins ( margins positive for tumor ) and reexcision among patients undergoing partial mastectomy for breast cancer .


In this randomized , controlled trial , we assigned , in a 1:1 ratio , 235 patients with breast cancer of stage 0 to III who were undergoing partial mastectomy , with or without resection of selective margins , to have further cavity shave margins resected ( shave group ) or not to have further cavity shave margins resected ( no-shave group ) .


Randomization occurred intraoperatively after surgeons had completed standard partial mastectomy .


Positive margins were defined as tumor touching the edge of the specimen that was removed in the case of invasive cancer and tumor that was within 1 mm of the edge of the specimen removed in the case of ductal carcinoma in situ .


The rate of positive margins was the primary outcome measure ; secondary outcome measures included cosmesis and the volume of tissue resected .


The median age of the patients was 61 years ( range , 33 to 94 ) .


On final pathological testing , 54 patients ( 23 % ) had invasive cancer , 45 ( 19 % ) had ductal carcinoma in situ , and 125 ( 53 % ) had both ; 11 patients had no further disease .


The median size of the tumor in the greatest diameter was 1.1 cm ( range , 0 to 6.5 ) in patients with invasive carcinoma and 1.0 cm ( range , 0 to 9.3 ) in patients with ductal carcinoma in situ .


Groups were well matched at baseline with respect to demographic and clinicopathological characteristics .


The rate of positive margins after partial mastectomy ( before randomization ) was similar in the shave group and the no-shave group ( 36 % and 34 % , respectively ; P = 0.69 ) .


After randomization , patients in the shave group had a significantly lower rate of positive margins than did those in the no-shave group ( 19 % vs. 34 % , P = 0.01 ) , as well as a lower rate of second surgery for margin clearance ( 10 % vs. 21 % , P = 0.02 ) .


There was no significant difference in complications between the two groups .


Cavity shaving halved the rates of positive margins and reexcision among patients with partial mastectomy .


( Funded by the Yale Cancer Center ; ClinicalTrials.gov number , NCT01452399 . )


Nuclear and cytoplasmic competence of human oocyte is critical for future competence of the embryo upon which ultimately depends the outcome of an ART ( Assisted Reproductive Technology ) treatment .


Follicular microenvironment in which the oocyte develops is crucial , and this must be taken into account particularly with the use of hormonal ovarian stimulation protocols .


Inositol is an important element of the follicular environment and data support that its higher level in follicular fluid correlates with the development of a good oocyte .


Aim of this study is to understand the effects of treatment with inositol on oocyte quality in a sample of patients undergoing ICSI ( Intracytoplasmic Sperm Injection ) .


Assessment of oocyte/embryo quality and pregnancy rates in 149 patients divided , according to a controlled randomized pattern , into two groups : study group 1 treated with folic acid and inositol and control group 2 treated with folic acid alone .


The number of patients with excellent and good oocyte quality appears to be significantly higher in group 1 ( p = 0.02 ) , as shown , they significantly increased the number of embryos of grade A transferred in the group 1 ( p = 0.02 ) compared to group 2 , despite being completely similar averages of total embryos transferred ( total mean SD = 2.4 0.8 , group 1 mean SD = 2.4 0.8 , group 2 mean SD = 2.4 0.8 ) .


There is not any significant difference between groups 1 and 2 in the number of positivity to - hCG and in the number of biochemical pregnancies detected although it has a tendency to increase in the first and to decrease in the second for group 1 .


The increase in percentage of clinical pregnancies in group 1 was statistically significant ( p = 0.02 ) , whereas there was no apparent significance in the difference between the biochemical and clinical pregnancies in the two groups despite the positive trend in the study group .


Relying on `` inositol help '' to solidify our efforts , seems to be an easy path to help to deepen the effectiveness of its use in all patients still under 40 but with prior failed attempts at ICSI or diagnosed with PCOS or as `` poor responders '' .


Unsedated transnasal upper endoscopy ( TNE ) has been suggested as a more comfortable and safer method than unsedated transoral endoscopy ( TOE ) .


However , the numbers of comparative trials are limited .


The current study aimed to assess the tolerability , safety , and efficacy of TNE in endoscopy nave patients .


The current study was designed as a randomized , prospective , parallel arm trial including all eligible patients referred for upper endoscopy .


Patients were randomized with a 1:1 ratio to undergo either unsedated TOE using a standard endoscope or unsedated TNE using an ultrathin endoscope .


Postprocedure , all patients were asked to complete a questionnaire to assess pain , discomfort , distress and tolerability using a 10 cm visual analog scale ( VAS ) .


Patients ' expectations and future preferences were also determined by multiple choice questions .


Endoscope insertion rate , procedure duration , and side-effects were recorded for each patient .


Each group included 200 patients .


With the exception of nasal pain , mean VAS scores were significantly lower in TNE patients when compared to TOE patients ( p = 0.0001 ) .


85 % and 54.5 % of patients in TNE and TOE groups , respectively , found the procedure better than expected ( p = 0001 ) .


A repeat procedure was significantly more acceptable for TNE than TOE ( 82.4 % and 60.5 % , respectively ) .


Endoscope insertion failed in 3.5 % of TNE patients .


Mild epistaxis was observed in 4 % of TNE patients .


Unsedated TNE was tolerated better in endoscopy naive patients than unsedated TOE in a large parallel arm trial .


Oxycodone is semi-synthetic opioid , oral and parenteral preparations have been widely used for acute and chronic pain .


The aim of this study was to assess the efficacy and side effects of oxycodone and fentanyl in patient controlled analgesia ( PCA ) after laparoscopic cholecystectomy .


A prospective , randomized , double-blind study was conducted .


81 patients were randomly divided into two groups ; fentanyl ( 10 mcg fentanyl and 1.5 mg ketorolac ) and oxycodone group ( 1 mg oxycodone and 1.5 mg ketorolac ) .


After the operation , a blinded observer assessed pain using a numerical rating scale ( NRS ) , infused PCA dose , side effects , sedation levels , and satisfaction .


Cumulative PCA dose of oxycodone group at 48 h ( 31.4 16.0 ml ) was significantly less than that of fentanyl group ( 43.8 23.1 ml , P = 0.009 ) .


Oxycodone group showed more nausea at 6-24 h after the operation ( P = 0.001 ) , but there was no difference in satisfaction score ( P = 0.073 ) .


There were no significant differences in other side effects , sedation and NRS scores between two groups .


Oxycodone showed comparable effects for pain relief compared to fentanyl in spite of less cumulative PCA dose .


Based on these results , we could conclude that oxycodone may be useful as an alternative to fentanyl for PCA after laparoscopic cholecystectomy .


To compare the visual and refractive out-comes of femtosecond laser-assisted LASIK with small-incision lenticule extraction ( SMILE ) in terms of visual acuity , contrast sensitivity , aberrations , and dry eye .


A single-center prospective randomized study in which patients diagnosed as having myopia presenting for refractive correction were allocated to either a LASIK or SMILE group .


The primary outcome measures were refractive efficacy , predictability , and safety , postoperative contrast sensitivity , aberrations , and dry eye status .


Patients were followed up at days 1 and 15 and 3 months ; postoperative uncorrected visual acuity ( UCVA ) , aberrations , dry eye , and contrast sensitivity were recorded and compared to preoperative data .


Two postoperative subjective questionnaires were used to assess pain , pricking sensation , redness , glare , and overall patient satisfaction .


At day 1 postoperatively , 48 ( 96 % ) of 50 eyes in the SMILE group achieved a UCVA of 20/20 compared with 46 ( 92 % ) of 50 eyes in the LASIK group .


At day 15 postoperatively , contrast sensitivity was similar in the two groups ( P = .15 ) , but by 3 months , it was better in the SMILE group than the LASIK group at all spatial frequencies ( P < .0001 ) .


At 3 months postoperatively , 42 ( 84 % ) eyes in each group achieved a UCVA of 20/20 , with 6 ( 12 % ) eyes in the SMILE group and 2 ( 4 % ) eyes in the LASIK group achieving 20/15 .


Higher-order aberrations at 3 months postoperatively were significantly higher in the LASIK group ( 0.437 + 0.103 pm ) than in the SMILE group ( 0.267 + 0.07 pm ; P < .001 ) .


Postoperative dry eye and glare were significantly more common following LASIK ( P < .001 ) .


Three-month results demonstrate that refractive accuracy , dry eye , contrast , and induced aberrations are better following SMILE rather than LASIK .


Therapies for post-traumatic stress disorder ( PTSD ) endorsed by the Department of Defense and Veterans Administration are relatively lengthy , costly , and yield variable success .


We evaluated Accelerated Resolution Therapy ( ART ) for the treatment of combat-related psychological trauma .


A randomized controlled trial of ART versus an Attention Control ( AC ) regimen was conducted among 57 U.S. service members/veterans .


After random assignment , those assigned to AC were offered crossover to ART , with 3-month follow-up on all participants .


Self-report symptoms of PTSD and comorbidities were analyzed among study completers and by the intention-to-treat principle .


Mean age was 41 13 years with 19 % female , 54 % Army , and 68 % with prior PTSD treatment .


The ART was delivered in 3.7 1.1 sessions with a 94 % completion rate .


Mean reductions in symptoms of PTSD , depression , anxiety , and trauma-related guilt were significantly greater ( p < 0.001 ) with ART compared to AC .


Favorable results for those treated with ART persisted at 3 months , including reduction in aggression ( p < 0.0001 ) .


Adverse treatment-related events were rare and not serious .


ART appears to be a safe and effective treatment for symptoms of combat-related PTSD , including refractory PTSD , and is delivered in significantly less time than therapies endorsed by the Department of Defense and Veterans Administration .


Current treatments for low back pain have small effects .


A research priority is to identify patient characteristics associated with larger effects for specific interventions .


The aim of this study was to identify simple clinical characteristics of patients with chronic low back pain who would benefit more from either motor control exercises or graded activity .


This study was a secondary analysis of the results of a randomized controlled trial .


One hundred seventy-two patients with chronic low back pain were enrolled in the trial , which was conducted in Australian physical therapy clinics .


The treatment consisted of 12 initial exercise sessions over an 8-week period and booster sessions at 4 and 10 months following randomization .


The putative effect modifiers ( psychosocial features , physical activity level , walking tolerance , and self-reported signs of clinical instability ) were measured at baseline .


Measures of pain and function ( both measured on a 0-10 scale ) were taken at baseline and at 2 , 6 , and 12 months by a blinded assessor .


Self-reported clinical instability was a statistically significant and clinically important modifier of treatment response for 12-month function ( interaction : 2.72 ; 95 % confidence interval = 1.39 to 4.06 ) .


Participants with high scores on the clinical instability questionnaire ( 9 ) did 0.76 points better with motor control exercises , whereas those who had low scores ( < 9 ) did 1.93 points better with graded activity .


Most other effect modifiers investigated did not appear to be useful in identifying preferential response to exercise type .


The psychometric properties of the instability questionnaire have not been fully tested .


A simple 15-item questionnaire of features considered indicative of clinical instability can identify patients who respond best to either motor control exercises or graded activity .


The multicomponent serogroup B meningococcal ( 4CMenB ) vaccine induces antibodies against indicator strains of serogroup B meningococcus under various schedules .


We investigated the persistence of antibodies in 5-year-old children 18-20 months after their last dose ( at about 3.5 years of age ) .


We assessed 5-year-old children who received the 4CMenB vaccine or a recombinant protein vaccine in a previous randomized trial .


We also recruited 50 vaccine-naive 5-year-olds and administered 2 doses of 4CMenB to each child .


We measured serum bactericidal antibody titres against 4 indicator strains of serogroup B meningococcus matched to each individual vaccine component and against 4 mismatched strains .


Of those who received the 4CMenB vaccine at 2 , 4 , 6 , 12 and 40 months ( n = 16 ) , the percentage with protective antibody titres ( 1:4 ) at 60 months ranged from 44 % to 88 % against matched strains and from 13 % to 81 % against mismatched strains .


Loss of protective titres was also observed for those who received the 4CMenB vaccine at 12 , 40 and 42 months ( n = 5 ) ( 80 % -100 % against matched strains , 60 % -100 % against mismatched strains ) or at 40 and 42 months ( n = 29 ) ( 31 % -100 % against matched strains , 41 % -81 % against mismatched strains ) .


Administering the 4CMenB vaccine to 5-year-old children yielded protective titres against matched strains in 92 % -100 % and against mismatched strains in 59 % -100 % .


The majority of these children reported injection-site pain ( 40/50 [ 80 % ] after dose 1 , 39/46 [ 85 % ] after dose 2 ) and erythema ( 47/50 [ 94 % ] and 40/46 [ 87 % ] , respectively ) ; rates of fever were low ( 5/50 [ 10 % ] and 2/46 [ 4 % ] , respectively ) .


Waning of immunity by 5 years of age occurred after receipt of the 4CMenB vaccine in infancy , even with an additional booster at 40 months .


The 4CMenB vaccine is immunogenic and was fairly well tolerated by 5-year-old children , although injection-site pain was noteworthy .


ClinicalTrials.gov , no .


NCT01027351 .


To evaluate the effect of drainage tube on prognosis after total knee arthroplasty ( TKA ) and explore an effective treatment with favorable prognosis .


In a prospective study , 18 patients with TKA for the first time were included and randomly divided into three groups , group A ( no placement of drainage tube ) , group B ( negative pressure drainage ) , and group C ( 4 h clamping drainage ) .


Intraoperative and postoperative blood loss , operation time , and the drainage volume were recorded and analyzed .


Arthrocele , ecchymosis , and range of motion ( ROM ) were examined postoperatively .


The degree of pain was scored by Visual Analog Scale ( VAS ) after 6 , 12 , and 24 h of operation .


The complications were examined and HSS ( hospital for special surgery ) knee score was taken during the follow-up period .


There was no significant difference in operation time , total blood loss , intraoperative blood loss , and VAS score among three groups .


Meanwhile , the hidden blood loss in group B was significantly decreased compared with group A ( P = 0.0015 ) .


The postoperative drainage volume of group B was significantly increased compared with group C ( P = 0.0002 ) .


No drainage increased the rate of arthrocele and ecchymosis .


Compared with group A , ROM after 3 days of operation in groups B and C was significantly increased ( P = 0.0357 , P = 0.0372 , respectively ) .


During follow-up study , no deep infection or deep venous thrombosis was found .


After TKA , early clamping of the drainage tube reduced the bleeding loss without adverse effect on prognosis , which might be useful for clinical application in future .


The main goal of this study was to achieve a medico-economic comparison between four disposable laryngeal masks ( LM ) ( LMA-Unique , Ambu AuraOnce , I-Gel and LMA-Suprme ) .


A prospective , randomized , monocentre study .


In a center , using routinely LMA-Unique masks , scheduled breast surgery patients were allocated into four groups according to the LM model .


After the induction , the modalities of use were collected , as well as the intraoperative events that required additional anesthetic equipment .


The real cost of each model was calculated ( cost of the mask + extra cost related to complications ) .


Using the LMA-Unique as a reference , we performed a cost-efficacy analysis .


We realized a cost-efficiency analysis putting in parallel the impact on the cost and the incidence of the events .


A total of 178 patients were included .


According to the cost-efficacy analysis , the dominant model was the Ambu AuraOnce ( real cost : -34.2 % , events : -30.6 % ) .


The LMA-Unique was dominated because of a high morbidity rate .


The I-Gel and LMA-Suprme models were more efficient but more expensive ( real cost : +16 % and +22.5 % respectively ) .


To compensate for additional costs , it would be necessary to apply a price reduction of at least 50 % .


Despite their better efficiency and safety , the latest generation laryngeal masks are still expensive in spite of a low rate of complication .


These results do not take into account very rare and severe complications not met in this study in the limited size ; then the economic and medical impact can influence the choice beyond the simple analysis cost-efficiency .


We evaluated the safety and efficacy of a novel disposable male circumcision ( MC ) device developed by Jiangxi-Yuansheng-Langhe Medical Instrument Co. , Ltd. .


Adult male patients ( n = 120 ; mean age , 26.6 years ) with redundant foreskin and/or phimosis were included in a randomized , multicenter pilot clinical trial from October 2011 to February 2012 .


Patients were divided into 2 groups and subjected to MC with a novel disposable device ( Device Group ) ( n = 60 ) or to conventional dissection technique ( CDT ) ( Control Group ) ( n = 60 ) .


Intraoperative bleeding , surgery duration , pain , healing , and satisfaction with penis appearance were assessed .


Adverse events ( AEs ) were noted .


Intraoperative bleeding volume [ 3.5 2.7 ( 15-35 ) ml vs. 13.1 6.1 ( 4-25 ) ml ] and mean surgical time [ 7.6 4.5 ( 2-23 ) min vs. 23.6 4.4 ( 15-35 ) min ] in the Device Group were significantly less than in the Control Group ( P < 0.01 ) .


No AEs were observed in either group .


There were no significant differences in postoperative pain , healing , or satisfaction with penis appearance between groups ( P > 0.05 ) .


This novel disposable circumcision device produced satisfactory preliminary adult MC results compared with CDT treatments .


This device may be broadly used in men , such as those with phimosis , who are ineligible for CDT .


Increased potassium intake is related to reduced blood pressure ( BP ) and reduced stroke rate .


The effect of increased dietary potassium on endothelial function remains unknown .


The aim was to determine the effect of increased dietary potassium from fruit and vegetables on endothelial function .


Thirty five healthy men and women ( age 32 12 y ) successfully completed a randomised cross-over study of 2 6 day diets either high or low in potassium .


Flow mediated dilatation ( FMD ) , BP , pulse wave velocity ( PWV ) , augmentation index ( AI ) and a fasting blood sample for analysis of Intercellular Adhesion Molecule-1 ( ICAM-1 ) , E-selectin , asymmetric dimethylarginine ( ADMA ) and endothelin-1 were taken on completion of each intervention .


Dietary change was achieved by including bananas and potatoes in the high potassium and apples and rice/pasta in the low potassium diet .


Dietary adherence was assessed using 6 day weighed food diaries and a 24 h urine sample .


The difference in potassium excretion between the two diets was 48 32 mmol/d ( P = 0.000 ) .


Fasting FMD was significantly improved by 0.6 % 1.5 % following the high compared to the low potassium diet ( P = 0.03 ) .


There were no significant differences in BP , PWV , AI , ICAM-1 , ADMA or endothelin-1 between the interventions .


There was a significant reduction in E-selectin following the high ( Median = 5.96 ng/ml ) vs the low potassium diet ( Median = 6.24 ng/ml ) , z = -2.49 , P = 0.013 .


Increased dietary potassium from fruit and vegetables improves FMD within 1 week in healthy men and women but the mechanisms for this effect remain unclear .


ACTRN12612000822886 .


Spine Patient Outcomes Research Trial subgroup analysis .


To evaluate the effect of high obesity on management of lumbar spinal stenosis , degenerative spondylolisthesis ( DS ) , and intervertebral disc herniation ( IDH ) .


Prior Spine Patient Outcomes Research Trial analyses compared nonobese and obese patients .


This study compares nonobese patients ( body mass index < 30 kg/m ) with those with class I obesity ( body mass index = 30-35 kg/m ) and class II/III high obesity ( body mass index35 kg/m ) .


For spinal stenosis , 250 of 634 nonobese patients , 104 of 167 obese patients , and 59 of 94 highly obese patients underwent surgery .


For DS , 233 of 376 nonobese patients , 90 of 129 obese patients , and 66 of 96 highly obese patients underwent surgery .


For IDH , 542 of 854 nonobese patients , 151 of 207 obese patients , and 94 of 129 highly obese patients underwent surgery .


Outcomes included Short Form-36 , Oswestry Disability Index , stenosis/sciatica bothersomeness index , low back pain bothersomeness index , operative events , complications , and reoperations .


Operative and nonoperative outcomes were compared by change from baseline at each follow-up interval using a mixed effects longitudinal regression model .


An as-treated analysis was performed because of crossover between surgical and nonoperative groups .


Highly obese patients had increased comorbidities .


Baseline Short Form-36 physical function scores were lowest for highly obese patients .


For spinal stenosis , surgical treatment effect and difference in operative events among groups were not significantly different.For DS , greatest treatment effect for the highly obese group was found in most primary outcome measures , and is attributable to the significantly poorer nonoperative outcomes .


Operative times and wound infection rates were greatest for highly obese patients.For IDH , highly obese patients experienced less improvement postoperatively compared with obese and nonobese patients .


However , nonoperative treatment for highly obese patients was even worse , resulting in greater treatment effect in almost all measures .


Operative time was greatest for highly obese patients .


Blood loss and length of stay was greater for both obese cohorts .


Highly obese patients with DS experienced longer operative times and increased infection .


Operative time was greatest for highly obese patients with IDH .


DS and IDH saw greater surgical treatment effect for highly obese patients due to poor outcomes of nonsurgical management .


3 .


Laparoscopy training courses have been established in many centers worldwide to ensure adequate skill learning before performing operations on patients .


Different training modalities and their combinations have been compared regarding training effects .


Multimodality training combines different approaches for optimal training outcome .


However , no standards currently exist for the number of trainees assigned per workplace .


This is a monocentric , open , three-arm randomized controlled trial .


The participants are laparoscopically-naive medical students from Heidelberg University .


After a standardized introduction to laparoscopic cholecystectomy ( LC ) with online learning modules , the participants perform a baseline test for basic skills and LC performance on a virtual reality ( VR ) trainer .


A total of 100 students will be randomized into three study arms , in a 2:2:1 ratio .


The intervention groups participate individually ( Group 1 ) or in pairs ( Group 2 ) in a standardized and structured multimodality training curriculum .


Basic skills are trained on the box and VR trainers .


Procedural skills and LC modules are trained on the VR trainer .


The control group ( Group C ) does not receive training between tests .


A post-test is performed to reassess basic skills and LC performance on the VR trainer .


The performance of a cadaveric porcine LC is then measured as the primary outcome using standardized and validated ratings by blinded experts with the Objective Structured Assessment of Technical Skills .


The Global Operative Assessment of Laparoscopic Surgical skills score and the time taken for completion are used as secondary outcome measures as well as the improvement of skills and VR LC performance between baseline and post-test .


Cognitive tests and questionnaires are used to identify individual factors that might exert influence on training outcome .


This study aims to assess whether workplaces in laparoscopy training courses for beginners should be used by one trainee or two trainees simultaneously , by measuring the impact on operative performance and learning curves .


Possible factors of influence , such as the role of observing the training partner , exchange of thoughts , active reflection , model learning , motivation , pauses , and sympathy will be explored in the data analysis .


This study will help optimize the efficiency of laparoscopy training courses .


DRKS00004675 .


Limited time and lack of knowledge are barriers to physical activity counseling in primary care .


The objective of this study was to examine the effectiveness of a clinician-targeted intervention that used the 5As ( Ask , Advise , Agree , Assist , Arrange ) approach to physical activity counseling in a medically underserved patient population .


Family medicine clinicians at 2 community health centers were randomized to Group 1 or Group 2 intervention .


Both clinician groups participated in 4 training sessions on the 5As for physical activity counseling ; Group 2 training took place 8 months after Group 1 training .


Both groups were trained to refer patients to a community exercise program .


We used a pre-post analysis to evaluate the effectiveness of the intervention on clinician use of 5As .


Eligible patients ( n = 319 ) rated their clinicians ' counseling skills by using a modified Physical Activity Exit Interview ( PAEI ) survey .


Clinicians ( n = 10 ) self-assessed their use of the 5As through a survey and interviews .


Both patient and clinician groups had similar sociodemographic characteristics .


The PAEI score for both groups combined increased from 6.9 to 8.6 ( on a scale of 0-15 ) from baseline to immediately postintervention ( P = .01 ) and was 8.2 ( P = .09 ) at 6-month follow-up ; most of the improvement in PAEI score was due to increased use of 5As skills by Group 2 clinicians .


Group 1 reported difficulty with problem solving , whereas Group 2 reported ease of referral to the community exercise program .


A clinician training intervention showed mixed results for 5As physical activity counseling .


Antipsychotics , such as aripiprazole and risperidone , are often used to treat individuals with schizophrenia .


The efficacy as well as safety of aripiprazole in Western populations has been described .


The objective of this study is to investigate the efficacy , safety , and tolerability of aripiprazole and risperidone in Chinese Han schizophrenia subjects in mainland China .


The 6-week , double-blind , randomized , parallel study was conducted in 5 medical centers in mainland China from November 2007 to March 2011 .


A total of 279 subjects with a primary DSM-IV diagnosis of schizophrenia were randomly assigned ( with a randomization ratio of 1:1 ) to aripiprazole ( n = 139 ) or risperidone ( n = 140 ) .


Efficacy measurements included the Positive and Negative Syndrome Scale ( PANSS ) total , positive , negative and general psychopathology subscale scores , and Clinical Global Impressions-Severity of Illness ( CGI-S ) , and Improvement scale scores .


Extrapyramidal symptoms ( EPS ) , weight gain , serum prolactin level , QTc interval , and self-reported adverse events were also assessed as measures of safety and tolerability .


Both the aripiprazole and risperidone groups showed statistically significant improvement of PANSS total , positive , negative , general psychopathology subscale scores , and CGI-S scores from baseline to the endpoint ( all p < 0.01 ) .


Significant improvement was noted in the first week for both treatment groups .


There were no significant differences in efficacy measurements between the two treatment groups .


Mean change of PANSS total scores from baseline to the endpoint was -26.818.1 for aripiprazole and -30.017.7 for risperidone , ( p = 0.1475 ) .


The responder rate was 71 % ( n = 99 ) and 76 % ( n = 107 ) for aripiprazole and risperidone , respectively , ( p = 0.323 ) .


The incidences of EPS were similar in the aripiprazole ( 25 % , n = 35 ) and risperidone groups ( 24 % , n = 34 ) , respectively ( p = 0.757 ) .


No clinically meaningful effects on QTc interval , QRS duration , or PR interval were observed in either treatment groups .


However , the incidence of clinically significant weight gain ( p = 0.0118 ) and hyperprolactinemia ( p < 0.001 ) in the aripiprazole group was significantly lower than in the risperidone group .


The study demonstrated that aripiprazole , as well as risperidone , had rapid and persistent efficacy for psychotic symptoms from the first week of therapy .


There may be poor efficacy for aripiprazole compared with risperidone for overall improvement , but there were no significant differences in this study .


Aripiprazole showed good tolerability with less weight gain and hyperprolactinemia compared with risperidone .


The overall efficacy and safety of aripiprazole in Chinese Han schizophrenia subjects were similar to that reported in Western populations .


To observe the effectiveness and safety of Kangquan Recipe ( , KQR ) for benign prostatic hyperplasia ( BPH ) patients .