To compare the difference in the clinical efficacy on perennial allergic rhinitis between three nasal points acupuncture therapy and the oral administration of loratadine so as to provide the better acupuncture program in clinical treatment .


Sixty cases were randomized into an acupuncture group ( 30 cases ) and a medication group ( 30 cases ) .


In the acupuncture group , acupuncture was applied to three nasal points [ Yingxiang ( LI 20 ) , Yintang ( EX-HN 3 ) , Bitong ( Extra ) ] and acupoints selected by syndrome differentiation .


Acupuncture was given once every two days , three times a week , for 4 weeks totally .


In the medication group , loratadine was prescribed for oral administration , 10 mg every day , for 4 weeks .


The symptom and physical sign scores before and after treatment , as well the short-term and long-term efficacy were compared between the two groups .


The total effective rate was 96.7 % ( 29/30 ) in the acupuncture group and was 93.3 % ( 28/30 ) in the medication group after treatment .


The efficacy was similar between the two groups ( P > 0.05 ) .


In follow-up , the total effective rate was 86.7 % ( 26/30 ) in the acupuncture group , which was better than 56.7 % ( 17/30 , P < 0.05 ) in the medication group .


The scores of symptoms and physical signs after treatment and in follow-up were all reduced apparently as compared with those before treatment in the patients of the two groups ( all P < 0.05 ) .


The scores of symptoms and physical signs were reduced more apparently in the acupuncture group as compared with those in the medication group in follow-up ( all P < 0.05 ) .


The acupuncture at three nasal points and the acupoints selected by syndrome differentiation achieves the similar short-term efficacy on perennial allergic rhinitis as compared with the oral administration of loratadine .


The acupuncture therapy presents the obvious advantages on long-term efficacy .


Comparing the overall and differential effects of psychodynamic psychotherapy ( PDT ) versus cognitive behavior therapy ( CBT ) for social anxiety disorder ( SAD ) .


Patients with a primary SAD ( N = 47 ) were randomly assigned to PDT ( N = 22 ) or CBT ( N = 27 ) .


Both PDT and CBT consisted of up to 36 sessions ( average PDT 31.4 and CBT 19.8 sessions ) .


Assessments took place at waitlist : pretest , after 12 and 24 weeks for those who received longer treatment : posttest , 3-month and 1-year follow-up .


Changes in the main outcome measure self-reported social anxiety composite , as well as in other psychopathology , social skills , negative social beliefs , public self-consciousness , defense mechanisms , personal goals , independent rater 's judgments of SAD and general improvement , and approach behavior during an objective test , were analyzed using multilevel analysis .


No improvement occurred during waitlist .


Treatments were highly efficacious , with large within-subject effect sizes for social anxiety , but no differences between PDT and CBT on general and treatment-specific measures occurred .


Remission rates were over 50 % and similar for PDT and CBT .


Personality disorders did not influence the effects of PDT or CBT .


PDT and CBT are both effective approaches for SAD .


Further research is needed on the cost-effectiveness of PDT versus CBT , on different lengths PDT , and on patient preferences and their relationship to outcome of PDT versus CBT .


To examine how prenatal drug exposure ( PDE ) to heroin/cocaine and behavioral problems relate to adolescent drug experimentation .


The sample included African-American adolescents ( mean age = 14.2 years , SD = 1.2 ) with PDE ( n = 73 ) and a nonexposed community comparison ( n = 61 ) .


PDE status was determined at delivery through toxicology analysis and maternal report .


Internalizing/externalizing problems were assessed during adolescence with the Behavior Assessment System for Children , Second Edition .


Drug experimentation was assessed by adolescent report and urine analysis .


Logistic regression evaluated the likelihood of drug experimentation related to PDE and behavioral problems , adjusting for age , gender , PDE , perceived peer drug use , and caregiver drug use .


Interaction terms examined gender modification .


Sixty-seven subjects ( 50 % ) used drugs : 25 ( 19 % ) used tobacco/alcohol only and 42 ( 31 % ) used marijuana/illegal drugs .


Ninety-four subjects ( 70 % ) perceived peer drug use .


PDE significantly increased the risk of tobacco/alcohol experimentation ( odds ratio = 3.07 , 95 % confidence interval [ CI ] 1.09-8 .66 , p = .034 ) but not after covariate adjustment ( adjusted odds ratio [ aOR ] = 1.16 , 95 % CI .31 -4.33 , p > .05 ) .


PDE was not related to the overall or marijuana/illegal drug experimentation .


The likelihood of overall drug experimentation was doubled per SD increase in externalizing problems ( aOR = 2.28 , 95 % CI 1.33-3 .91 , p = .003 ) and , among girls , 2.82 times greater ( aOR = 2.82 , 95 % CI 1.34-5 .94 , p = .006 ) per SD increase in internalizing problems .


Age and perceived peer drug use were significant covariates .


Drug experimentation was relatively common ( 50 % ) , especially in the context of externalizing problems , internalizing problems ( girls only ) , older age , and perceived peer drug use .


Findings support the Problem Behavior Theory and suggest that adolescent drug prevention addresses behavioral problems and promotes prosocial peer groups .


Intra-articular triamcinolone in combination with DMARDs may be able to achieve faster and tighter control of disease activity in early rheumatoid arthritis that may be the key to preventing or minimizing later deformities .


To compare the efficacy of a combination of Disease Modifying Anti-Rheumatoid Drugs ( DMARDs ) with Intra-articular Glucocorticoids versus only DMARDs in a group of patients with early Rheumatoid Arthritis ( RA ) .


Fifty patients diagnosed as Rheumatoid Arthritis ( RA ) by American Rheumatology Association ( ARA ) criteria ( 1987 ) with disease duration less than two years were randomized into two groups .


The Control group received a combination of Methotrexate 15 mg daily with Sulfasalazine 2 gm daily for 3 months and the Study group received the above combination along with Intra-articular injections of Triamcinolone acetate ( 40 mg per ml ) in each of the swollen joints at the start of the study .


Outcome was assessed in terms of Disease Activity Score ( DAS-28 ) , American College of Rheumatology ( ACR ) 20/50/70 criteria and number of rescue medications used at the end of 3 months .


The study group had significant reductions in DAS 28 scores ( 3.39 versus 4.99 in control group ) and significantly more subjects achieved the ACR 20/50/70 criteria at the end of 3 months ( 100/60/36 % versus 84/20/0 % ) Secondary end-points like tender and swollen joint count , ESR , early morning stiffness , health assessment questionnaire ( HAQ ) scores and general health status were significantly reduced in the study group .


Also , significantly lesser rescue medications were needed in the study group .


Combination of DMARDs with Intra-articular corticosteroids is significantly better than DMARDs alone in early RA .


The Ipswich Touch Test is a novel method to detect subjects with diabetes with loss of foot sensation and is simple , safe , quick , and easy to perform and teach .


This study determines whether it can be used by relatives and/or carers to detect reduced foot sensation in the setting of the patient 's home .


The test involves lightly and briefly ( 1-2 s ) touching the tips of the first , third and fifth toes of both feet with the index finger .


Reduced foot sensation was defined as 2 insensate areas .


Patients due to attend clinic over a 4-week period were invited by post .


The invitation contained detailed instructions and a sheet for recording the results .


The findings were compared with those obtained in clinic using the 10-g monofilament at the same six sites .


Of 331 patients ( 174 males ) , 25.1 % ( n = 83 ) had 2 insensate areas to 10-g monofilament testing .


Compared with this , the Ipswich Touch Test at home had a sensitivity of 78.3 % and a specificity of 93.9 % .


The predictive values of detecting ` at-risk ' feet were positive at 81.2 % and negative at 92.8 % .


The likelihood ratios were positive at 12.9 and negative at 0.23 .


With clearly written instructions , this simple test can be used by non-professionals to accurately assess for loss of protective sensation .


We believe that the Ipswich Touch Test may also be a useful educational adjunct to improve awareness of diabetes foot disease in patients and relatives alike and empower them to seek appropriate care if sensation was found to be abnormal .


The cellular immunity has a profound impact on the status of hepatitis C virus ( HCV ) infection .


However , the response of cellular immunity on the virological response in patients with antiviral treatment remains largely unclear .


We aimed to clarify the response of peripheral T cells and monocytes in chronic hepatitis C patients with antiviral treatment .


Patients with chronic hepatitis C were treated either with interferon alpha-2b plus ribavirin ( n = 37 ) or with pegylated interferon alpha-2a plus ribavirin ( n = 33 ) for up to 24 weeks .


Frequencies of peripheral regulatory T-cells ( Tregs ) , programmed death-1 ( PD-1 ) expressing CD4 + T-cells or CD8 + T-cells and toll-like receptor ( TLR ) 3 expressing CD14 + monocytes were evaluated by flow cytometry in patients at baseline , 12 and 24 weeks following treatment and in 20 healthy controls .


Frequencies of Tregs , PD-1 and TLR3 expressing cells were higher in patients than those in control subjects ( P < 0.05 ) .


Patients with complete early virological response ( cEVR ) showed lower Tregs , PD-1 expressing CD4 + or CD8 + T-cells than those without cEVR at 12 weeks ( P < 0.05 ) .


Patients with low TLR3 expressing CD14 + monocytes at baseline had a high rate of cEVR ( P < 0.05 ) .


Low peripheral TLR3 expressing CD14 + monocytes at baseline could serve as a predictor for cEVR of antiviral therapy in chronic HCV-infected patients .


The cEVR rates were significantly increased in the patients with reduced circulating Tregs , PD-1 expressing CD4 + or CD8 + T-cells .


Chinese Clinical Trial Registry ChiCTR10001090 .


Few randomized trials have compared the results of Doppler-guided transanal hemorrhoid dearterialization with mucopexy and excisional open hemorrhoidectomy .


Few studies have reported long-term results .


The aim of this study is to evaluate the results of Doppler-guided transanal hemorrhoid dearterialization with mucopexy compared with excisional open hemorrhoidectomy in patients with grade III hemorrhoids .


This is a prospective randomized study registered at clinicaltrials.gov ( NCT01263431 ) .


A power analysis assessed the study 's sample size .


Patients were randomly assigned to undergo either hemorrhoidectomy or Doppler-guided hemorrhoid dearterialization plus mucopexy .


The test , Mann-Whitney U test , Student t test , and a regression model were used , as appropriate .


This study was conducted at the Department of Surgery , San Raffaele Scientific Institute , Milan , Italy .


Fifty consecutive patients were treated for grade III hemorrhoids from July to November 2010 .


The primary outcome was postoperative pain .


The secondary outcomes included postoperative morbidity , the resumption of social and/or working activity , patient satisfaction , and the relapse of symptoms at 1 and 24 months .


No major complications occurred in either group .


The median visual analog scale scores for pain in the hemorrhoidectomy and Doppler-guided dearterialization plus mucopexy groups on days 1 , 7 , 14 , and 30 were 7 vs 5.5 , 3 vs 2.5 , 1 vs 0 , and 0 vs 0 ( p > 0.05 ) .


The median work resumption day was the 22nd in the hemorrhoidectomy group and the 10th in the Doppler-guided dearterialization plus mucopexy group ( p = 0.09 ) .


Patient satisfaction at 1 and 24 postoperative months , with the use of a 4-point scale , was 3 vs 4 and 4 vs 4 ( p > 0.05 ) .


During the follow-up , 2 patients in the dearterialization group required ambulatory treatment , and 1 patient in each group required further surgery for symptom relapse .


Nonvalidated questionnaires were used in the follow-up .


Cost analysis was not performed .


Compared with hemorrhoidectomy , dearterialization with mucopexy resulted in similar postoperative pain and morbidity , and a similar long-term cure rate .


Management of antihistamine refractory chronic idiopathic urticaria ( CIU ) has poorly defined therapeutic options .


To evaluate the efficacy of dapsone ( 4,4 ' - diaminodiphenylsulfone ) in antihistamine refractory CIU compared with placebo .


Twenty-two patients with antihistamine refractory CIU were randomly assigned to 100 mg of dapsone daily or placebo for 6 weeks in a 14-week double-blind , placebo-controlled crossover trial .


End points were measured from a daily diary that reflected the weekly hive score , the weekly itch score , and a visual analog scale ( VAS ) score .


Secondary to a carryover effect , the first period results were analyzed as a parallel design that compared placebo with dapsone directly by using repeated-measures analysis .


After 6 weeks , the patients in the dapsone arm showed mean improvement over baseline in VAS ( 2.3 [ 95 % CI , 0.6-4 .1 ] , P = .01 ) , urticaria score ( -3.5 [ 95 % CI , -6.2 to -0.9 ] , P = .01 ) , and itch score ( -4.8 [ 95 % CI , -7.6 to -2.1 ] , P = .001 ) , whereas the placebo arm showed no improvement over baseline for VAS , urticaria , or itch scores .


Dapsone showed greater improvement compared with placebo for itch ( P = .047 ) and VAS ( P = .04 ) .


Of the 22 patients , 3 showed complete resolution of hives and itch with dapsone , whereas 31 % and 41 % had 50 % resolution of hives and itch , respectively .


No serious adverse effects were observed with dapsone .


To our knowledge , this is the first double-blind , placebo controlled study of dapsone in CIU and indicates that dapsone has efficacy in patients with antihistamine refractory CIU .


In alcohol-dependent patients , alcohol cues evoke increased activation in mesolimbic brain areas , such as the nucleus accumbens and the amygdala .


Moreover , patients show an alcohol approach bias , a tendency to more quickly approach than avoid alcohol cues .


Cognitive bias modification training , which aims to retrain approach biases , has been shown to reduce alcohol craving and relapse rates .


The authors investigated effects of this training on cue reactivity in alcohol-dependent patients .


In a double-blind randomized design , 32 abstinent alcohol-dependent patients received either bias modification training or sham training .


Both trainings consisted of six sessions of the joystick approach-avoidance task ; the bias modification training entailed pushing away 90 % of alcohol cues and 10 % of soft drink cues , whereas this ratio was 50/50 in the sham training .


Alcohol cue reactivity was measured with functional MRI before and after training .


Before training , alcohol cue-evoked activation was observed in the amygdala bilaterally , as well as in the right nucleus accumbens , although here it fell short of significance .


Activation in the amygdala correlated with craving and arousal ratings of alcohol stimuli ; correlations in the nucleus accumbens again fell short of significance .


After training , the bias modification group showed greater reductions in cue-evoked activation in the amygdala bilaterally and in behavioral arousal ratings of alcohol pictures , compared with the sham training group .


Decreases in right amygdala activity correlated with decreases in craving in the bias modification but not the sham training group .


These findings provide evidence that cognitive bias modification affects alcohol cue-induced mesolimbic brain activity .


Reductions in neural reactivity may be a key underlying mechanism of the therapeutic effectiveness of this training .


To compare the effectiveness of misoprostol sublingual and oral routes before manual vacuum aspiration ( MVA ) in first trimester termination of pregnancy .


A double-blinded randomized controlled trial was conducted infirst trimester termination ofpregnancy cases .


Eighty cases were recruited and divided into sublingual and oral groups .


Both groups were randomized to receive 400 microg misoprostol two hours prior to MVA .


Main outcomes were cervical dilatation , operative time , complications , side effects , pain scores , and patient satisfactions .


Sublingual group had significantly more cervical dilatation and shorter operative time than oral group ( 7.3 + / - 1.5 vs. 5.9 + / - 1.4 mm , p < 0.001 and 5.2 + / - 3.3 vs. 7.3 + / - 4.6 min , p = 0.02 , respectively ) .


However there were similar side effects , pain scores , and patient satisfactions in two groups .


The present study had no uterine perforation , cervical tear hemorrhage , or re-evacuation .


Sublingual misoprostol route was more effective for cervical priming prior to MVA in first trimester therapeutic abortion than oral route .


To compare the safety and efficacy of laser debulking ( LD ) and drug-eluting balloon ( DEB ) angioplasty to treatment with DEB angioplasty alone in patients affected by critical limb ischemia ( CLI ) and superficial femoral artery ( SFA ) chronic stent occlusion in a prospective , randomized study .


Among 448 CLI patients treated from December 2009 to March 2011 , 48 patients ( 39 men ; mean age 72.77.8 years ) with chronic SFA in-stent occlusion were randomly assigned to treatment using LD+DEB ( n = 24 ) or DEB angioplasty alone ( n = 24 ) .


Patency at 12 months was the primary outcome measure ; secondary outcomes were target lesion revascularization ( TLR ) and clinical success at 12 months .


In the LD+DEB group , the patency rates at 6 and 12 months ( 91.7 % and 66.7 % , respectively ) were significantly higher ( p = 0.01 ) than in the DEB only patients ( 58.3 % and 37.5 % , respectively ) .


TLR at 12 months was 16.7 % in the LD+DEB group and 50 % in the DEB only group ( p = 0.01 ) .


Two ( 8 % ) patients needed major amputations in the LD+DEB group vs. 11 ( 46 % ) in the DEB only group at 12 months ( p = 0.003 ) .


In this small initial experience , combined treatment with LD and DEB angioplasty is correlated with better outcomes in CLI patients with occluded SFA stents .


Hypertension is one of the most common co-existing conditions in patients with chronic pain , and the potential effects of an analgesic on heart rate and blood pressure are of particular concern for patients with hypertension .


The purpose of this analysis was to evaluate changes in blood pressure and heart rate with tapentadol extended release ( ER ) treatment in patients with hypertension .


We performed a post hoc analysis of data pooled from three randomized , placebo - and active-controlled , phase III studies of tapentadol ER for managing chronic osteoarthritis knee ( NCT00421928 , NCT00486811 ) or low back ( NCT00449176 ) pain ( 15-week , double-blind treatment period ) .


Data were independently analyzed for patients with a listed medical history of hypertension at baseline and patients with at least one listed concomitant antihypertensive medication at baseline .


Heart rate , systolic blood pressure ( SBP ) , and diastolic blood pressure ( DBP ) were measured at each visit .


In patients with a listed medical history of hypertension ( n = 1,464 ) , least-squares mean ( LSM [ standard error ( SE ) ] ) changes from baseline to endpoint with placebo , tapentadol ER , and oxycodone HCl controlled release ( CR ) , respectively , were -0.7 ( 0.44 ) , 0.2 ( 0.43 ) , and -0.9 ( 0.45 ) beats per minute ( bpm ) for heart rate ; -2.4 ( 0.64 ) , -2.7 ( 0.64 ) , and -3.7 ( 0.67 ) mmHg for SBP ; and -1.0 ( 0.39 ) , -1.3 ( 0.39 ) , and -2.3 ( 0.41 ) mmHg for DBP ; in patients with at least one listed concomitant antihypertensive medication ( n = 1,376 ) , the LSM ( SE ) changes from baseline to endpoint were -0.6 ( 0.45 ) , 0.1 ( 0.44 ) , and -0.7 ( 0.47 ) bpm for heart rate ; -1.8 ( 0.66 ) , -3.3 ( 0.65 ) , and -3.7 ( 0.69 ) mmHg for SBP ; and -0.7 ( 0.40 ) , -1.4 ( 0.40 ) , and -2.3 ( 0.42 ) mmHg for DBP .


No clinically meaningful mean changes in heart rate or blood pressure were observed for the evaluated cohorts of patients with hypertension who were treated with tapentadol ER ( 100-250 mg twice daily ) .


To assess the relative bioavailability of a new subcutaneous ( SC ) diclofenac hydroxypropyl b-cyclodextrin ( HPbCD ) formulation administered to three body sites : quadriceps , gluteus , and abdomen .


This was a pilot , single-dose , randomized , three-way crossover relative bioavailability study .


A total of 12 healthy subjects received a single SC injection of diclofenac HPbCD 50 mg/1 mL in the quadriceps , gluteus , or abdomen .


The AUC was comparable after SC diclofenac HPbCD in the quadriceps , gluteus , and abdomen .


The Cmax was comparable after SC administration in the quadriceps or abdomen , and ~ 17 % higher in the gluteus .


The absorption was rapid ( 30 minutes ) after administration of the treatment at any site .


The treatment was well tolerated .


The relative bioavailability of SC diclofenac HPbCD was comparable when administered to the quadriceps , gluteus , and abdomen .


The new diclofenac formulation can therefore be administered subcutaneously to any of these sites without clinically significant differences .


A further adequately powered study would be necessary to reveal any differences among injection sites in terms of peak plasma concentration .


To evaluate the correlation between the dosage frequency of sildenafil and its treatment outcomes in men with erectile dysfunction ( ED ) .


Data were from a 4-week , multicenter , observational study of men ( 1699 ) , between 18 and 60 years of age , with a clinical diagnosis of ED defined as the Sexual Health Inventory for Men ( SHIM ) score 21 .


The erectile function and quality of sexual life were evaluated at the baseline and the endpoint of sildenafil treatment ( after 4 weeks ) by using SHIM , Self-Esteem and Relationship Questionnaire , 36-Item Short Form Health Survey , Erection Hardness Score , and the global efficacy question .


Nine hundred thirty-five patients were enrolled in the 1 weekly , 573 in the 2-3 weekly , and 158 in the 4-7 weekly dosage frequency cohorts .


After 4 weeks of treatment , a higher dosage frequency of sildenafil was associated with a better SHIM , Self-Esteem and Relationship Questionnaire , and 36-Item Short Form Health Survey score improvement ( all P < .0001 ) .


Hyperlipidemia is a poor prognostic factor ( odds ratio , 3.59 ; P = .04 ) , whereas hypertension ( odds ratio , 0.25 ; P < .01 ) and coronary heart disease ( odds ratio , 0.56 ; P = .05 ) are sensitive to sildenafil treatment .


Higher dosage frequency of sildenafil is associated with a better improvement of sexual function and quality of life of men with ED , and the concomitant treatment of hyperlipidemia is recommended .


LigaSure , a bipolar electronic vessel sealing system , has become popular in abdominal surgery but few clinical studies have been conducted to evaluate its effectiveness in radical gastrectomy for gastric cancer .


In this multicenter , prospective , randomized controlled trial , patients with curative gastric cancer were randomly assigned to undergo gastrectomy either with LigaSure or a conventional technique .


Of the 160 patients enrolled , 80 were randomized to the LigaSure group and 78 to the conventional group .


Patient characteristics were well balanced in the two groups .


There were no significant differences between the LigaSure and conventional groups in blood loss ( 288 vs. 260ml , respectively ; P = 0.748 ) or operative time ( 223 and 225min , respectively ; P = 0.368 ) ; nor in the incidence of surgical complications or duration of postoperative hospital stay .


In a subgroup analysis of patients who underwent gastrectomy that preserved the distal part of the greater omentum , the use of LigaSure significantly reduced blood loss ( 179 vs. 245ml ; P = 0.033 ) , and the duration of the operation ( 195 vs. 221min ; P = 0.039 ) .


LigaSure did not contribute to reducing intraoperative blood loss , operative time , or other adverse surgical outcomes .


The usefulness of the device may be limited to a specific part of the surgical procedure in open gastrectomy .


Cerebral microbleeds have been observed in normal-appearing brain tissue of patients with glioma years after receiving radiation therapy .


The contrast of these paramagnetic lesions varies with field strength due to differences in the effects of susceptibility .


The purpose of this study was to compare 3T and 7T MRI as platforms for detecting cerebral microbleeds in patients treated with radiotherapy using susceptibility-weighted imaging ( SWI ) .


SWI was performed with both 3T and 7T MR scanners on ten patients with glioma who had received prior radiotherapy .


Imaging sequences were optimized to obtain data within a clinically acceptable scan time .


Both T2 * - weighted magnitude images and SWI data were reconstructed , minimum intensity projection was implemented , and microbleeds were manually identified .


The number of microbleeds was counted and compared among datasets .


Significantly more microbleeds were identified on SWI than magnitude images at both 7T ( p = 0.002 ) and 3T ( p = 0.023 ) .


Seven-tesla SWI detected significantly more microbleeds than 3T SWI for seven out of ten patients who had tumors located remote from deep brain regions ( p = 0.016 ) , but when the additional three patients with more inferior tumors were included , the difference was not significant .


SWI is more sensitive for detecting microbleeds than magnitude images at both 3T and 7T .


For areas without heightened susceptibility artifacts , 7T SWI is more sensitive to detecting radiation therapy-induced microbleeds than 3T SWI .


Tumor location should be considered in conjunction with field strength when selecting the most appropriate strategy for imaging microbleeds .


To assess the microflora of root canals in primary molars following use of rotary NiTi files and conventional hand NiTi and stainless steel files .


This randomized clinical trial consisted of a total of 60 first and second primary molars requiring root canal treatment , who were selected from children aged 5-9 years .


Based on type of root canal instrumentation , the teeth were randomly assigned to three groups of twenty teeth each ; Group A : Rotary NiTi files , Group B : Hand NiTi files and Group C : Hand stainless steel files .


Following administration of local anesthesia , isolation with rubber dam was carried out .


For the purpose of instrumentation and sampling , the palatal canal of maxillary molars and the distal canal of mandibular molars were selected .


Prior to sampling , the orifices of other canals in these teeth were sealed , so as to prevent any contamination .


Instrumentation was carried out in each group using respective instruments along with intermittent saline irrigation .


Root canal samples were obtained both before and after instrumentation , using sterile absorbent paper points and transferred to a sterile vial with transport fluid .


Serial dilutions were prepared and cultured on suitable agar media .


Both aerobic and anaerobic microbial counts were made .


Data obtained was subjected to statistical analysis using Wilcoxon signed rank test and one-way Analysis of variance .


In all three groups , there was a significant reduction in both aerobic and anaerobic mean microbial count following root canal instrumentation .


( p < 0.001 ) .


Rotary NiTi files were as efficient as conventional hand instruments in significantly reducing the root canal microflora .


Disruptive behavior is common in children with autism spectrum disorder .


Behavioral interventions are used to treat disruptive behavior but have not been evaluated in large-scale randomized trials .


To evaluate the efficacy of parent training for children with autism spectrum disorder and disruptive behavior .


This 24-week randomized trial compared parent training ( n = 89 ) to parent education ( n = 91 ) at 6 centers ( Emory University , Indiana University , Ohio State University , University of Pittsburgh , University of Rochester , Yale University ) .


We screened 267 children ; 180 children ( aged 3-7 years ) with autism spectrum disorder and disruptive behaviors were randomly assigned ( 86 % white , 88 % male ) between September 2010 and February 2014 .


Parent training ( 11 core , 2 optional sessions ; 2 telephone boosters ; 2 home visits ) provided specific strategies to manage disruptive behavior .


Parent education ( 12 core sessions , 1 home visit ) provided information about autism but no behavior management strategies .


Parents rated disruptive behavior and noncompliance on co-primary outcomes : the Aberrant Behavior Checklist-Irritability subscale ( range , 0-45 ) and the Home Situations Questionnaire-Autism Spectrum Disorder ( range , 0-9 ) .


On both measures , higher scores indicate greater severity and a 25 % reduction indicates clinical improvement .


A clinician blind to treatment assignment rated the Improvement scale of the Clinical Global Impression ( range , 1-7 ) , a secondary outcome , with a positive response less than 3 .


At week 24 , the Aberrant Behavior Checklist-Irritability subscale declined 47.7 % in parent training ( from 23.7 to 12.4 ) compared with 31.8 % for parent education ( 23.9 to 16.3 ) ( treatment effect , -3.9 ; 95 % CI , -6.2 to -1.7 ; P < .001 , standardized effect size = 0.62 ) .


The Home Situations Questionnaire-Autism Spectrum Disorder declined 55 % ( from 4.0 to 1.8 ) compared with 34.2 % in parent education ( 3.8 to 2.5 ) ( treatment effect , -0.7 ; 95 % CI , -1.1 to -0.3 ; P < .001 , standardized effect size = 0.45 ) .


Neither measure met the prespecified minimal clinically important difference .


The proportions with a positive response on the Clinical Global Impression-Improvement scale were 68.5 % for parent training vs 39.6 % for parent education ( P < .001 ) .


For children with autism spectrum disorder , a 24-week parent training program was superior to parent education for reducing disruptive behavior on parent-reported outcomes , although the clinical significance of the improvement is unclear .


The rate of positive response judged by a blinded clinician was greater for parent training vs parent education .


clinicaltrials.gov Identifier : NCT01233414 .


As relapse after completed cognitive behavior therapy ( CBT ) for obsessive-compulsive disorder ( OCD ) is common , many treatment protocols include booster programs to improve the long-term effects .


However , the effects of booster programs are not well studied .


In this study , we investigated the long-term efficacy of Internet-based CBT ( ICBT ) with therapist support for OCD with or without an Internet-based booster program .


A total of 101 participants were included in the long-term follow-up analysis of ICBT .


Of these , 93 were randomized to a booster program or no booster program .


Outcome assessments were collected at 4 , 7 , 12 and 24 months after receiving ICBT .


The entire sample had sustained long-term effects from pre-treatment to all follow-up assessments , with large within-group effect sizes ( Cohen 's d = 1.58-2 .09 ) .


The booster group had a significant mean reduction in OCD symptoms compared to the control condition from booster baseline ( 4 months ) to 7 months , but not at 12 or 24 months .


Participants in the booster group improved significantly in terms of general functioning at 7 , 12 and 24 months , and had fewer relapses .


Kaplan-Meier analysis also indicated a significantly slower relapse rate in the booster group .


The results suggest that ICBT has sustained long-term effects and that adding an Internet-based booster program can further improve long-term outcome and prevent relapse for some OCD patients .


Data from an open label randomised controlled trial have suggested possible advantages on both motor and non-motor measures in patients with Parkinson 's disease following 12 months exposure to exenatide .


Continued follow up of these same patients was performed to investigate whether these possible advantages persisted in the prolonged absence of this medication .


All participants from an open label , randomised controlled trial of exenatide as a treatment for Parkinson 's disease , were invited for a further follow up assessment at the UCL Institute of Neurology .


This visit included all 20 individuals who had previously completed twelve months exposure to exenatide 10ug bd and the 24 individuals who had acted as randomised controls .


Motor severity of PD was compared after overnight withdrawal of conventional PD medication using blinded video assessment of the MDS-UPDRS , together with several non-motor tests .


This assessment was thus 24 months after their original baseline visit , i.e. 12 months after cessation of exenatide .


Compared to the control group of patients , patients previously exposed to exenatide had an advantage of 5.6 points ( 95 % CI , 2.2-9 .0 ; p = 0.002 ) using blinded video rating of the MDS-UPDRS part 3 motor subscale .


There was also a difference of 5.3 points ; ( 95 % CI , 9.3-1 .4 ; p = 0.006 ) between the 2 groups on the Mattis Dementia Rating scale .


While these data must still not be interpreted as evidence of neuroprotection , they nevertheless provide strong encouragement for the further study of this drug as a potential disease modifying agent in Parkinson 's disease .


The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation ( MANTRA-PAF ) trial assessed the long-term efficacy of an initial strategy of radiofrequency ablation ( RFA ) vs. antiarrhythmic drug therapy ( AAD ) as first-line treatment for patients with PAF .


In this substudy , we evaluated the effect of these treatment modalities on the Health-Related Quality of Life ( HRQoL ) and symptom burden of patients at 12 and 24 months .


During the study period , 294 patients were enrolled in the MANTRA-PAF trial and randomized to receive AAD ( N = 148 ) or RFA ( N = 146 ) .


Two generic questionnaires were used to assess the HRQoL [ Short Form-36 ( SF-36 ) and EuroQol-five dimensions ( EQ-5D ) ] , and the Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia ( ASTA ) was used to evaluate the symptoms appearing during the trial .


All comparisons were made on an intention-to-treat basis .


Both randomization groups showed significant improvements in assessments with both SF-36 and EQ-5D , at 24 months .


Patients randomized to RFA showed significantly greater improvement in four physically related scales of the SF-36 .


The three most frequently reported symptoms were breathlessness during activity , pronounced tiredness , and worry/anxiety .


In both groups , there was a significant reduction in ASTA symptom index and in the severity of seven of the eight symptoms over time .


Both AAD and RFA as first-line treatment resulted in substantial improvement of HRQoL and symptom burden in patients with PAF .


Patients randomized to RFA showed greater improvement in physical scales ( SF-36 ) and the EQ-visual analogue scale .


URL http://www.clinicaltrials.gov .


Unique identifier : NCT00133211 .


To establish the efficiency of bowel ligatures in colon cancer surgery , focusing on the extent to which exfoliated cancer cells are shed in the colonic lumen during sigmoidectomy .


Twenty consecutive patients who underwent sigmoidectomy for sigmoid colon cancer were prospectively randomized into two groups : the `` ligatures group '' , in which bowel ligatures were placed , 3 , 5 , 10 cm from the tumor proximally and distally before dissection ; and the `` no ligatures group '' , in which the corresponding sites were ligated only immediately before taking the specimen out .


Each colonic segment ligated was irrigated with saline and samples were sent for blind cytological examination .


Cancer cells were found in the colonic segment where the tumor was located , in 18 of 20 samples .


The frequency of free cancer cells decreased from 50 to 0 % ( p < 0.04 ) in the distal 3-5 cm colonic segment and from 80 to 20 % ( p < 0.03 ) in the proximal colonic segment after performing bowel ligatures .


Free cancer cells were confirmed in 1 of 10 samples at both colonic segments 5-10 cm from the tumor , even after bowel ligatures .


Intraluminal exfoliated cancer cells could be eliminated by placing bowel ligatures during sigmoidectomy .


Measures should be considered to eliminate exfoliated cancer cells during colectomy , even after placing bowel ligatures .


To compare postoperative visual symptoms and spectacle freedom after bilateral implantation of the AT LISA 809M ( Carl Zeiss Meditec , Jena , Germany ) versus the AcrySof ReSTOR SN6AD1 ( Alcon Laboratories , Irvine , CA ) multifocal intraocular lens ( IOL ) .


Double-masked , prospective , randomized , controlled clinical trial .


A total of 188 patients undergoing bilateral sequential cataract surgery or bilateral refractive lens exchange .


Patients were preoperatively randomized ( allocation ratio 1:1 ) to bilateral implantation with the AT LISA 809M IOL or ReSTOR SN6AD1 IOL .


Postoperative outcomes were assessed 4 to 8 months after second eye surgery .


The primary outcome was visual symptoms evaluated with the Quality of Vision ( QoV ) questionnaire .


Secondary outcomes included other questionnaire data ( CatQuest-9SF , spectacle independence , vision satisfaction , and dysphotopsia ) and visual function measures ( near , intermediate , and distance visual acuity , binocular reading speed [ International Reading Speed Texts ] , contrast sensitivity , and forward light scatter ) .


Adverse events , including intraoperative and postoperative complications , also were evaluated .


There was no significant difference between IOL groups in Rasch-adjusted QoV scores for frequency ( P = 0.95 ) , severity ( P = 0.56 ) , and bothersomeness ( P = 0.34 ) of visual symptoms ; median ( interquartile ) scores for these QoV subscales were 29 ( 15-37 ) , 22 ( 13-27 ) , and 14 ( 0-29 ) for the AT LISA 809M IOL group , respectively , and 32 ( 15-37 ) , 22 ( 13-30 ) , and 14 ( 0-29 ) for the ReSTOR SN6AD1 IOL group , respectively .


Halo was the most prominent dysphotopsia symptom , with 6 % in both IOL groups reporting halo symptoms as very bothersome .


Complete spectacle independence was achieved in 69 of 84 ( 82.1 % ) AT LISA 809M recipients and 66 of 85 ( 77.6 % ) ReSTOR SN6AD1 recipients ( P = 0.57 ) .


Preferred reading distance was slightly nearer for the AT LISA 809M IOL .


There were no statistically significant differences in any of the other secondary outcome measures .


Visual symptoms were similar after bilateral implantation of the AT LISA 809M and ReSTOR SN6AD1 IOLs .


Both these diffractive bifocal IOLs produce high levels of spectacle independence and patient satisfaction .


However , a small but clinically significant minority of patients remained symptomatic and dissatisfied with visual results 4 to 8 months after surgery .


Little is known about how colorectal cancer screening test preferences operate together with test access and navigation to influence screening adherence in primary care .


We analyzed data from a randomized trial of 945 primary care patients to assess the independent effects of screening test preference for fecal immunochemical test ( FIT ) or colonoscopy , mailed access to FIT and colonoscopy , and telephone navigation for FIT and colonoscopy , on screening .


Preference was not associated with overall screening , but individuals who preferred FIT were more likely to complete FIT screening ( P = 0.005 ) , whereas those who preferred colonoscopy were more likely to perform colonoscopy screening ( P = 0.032 ) .


Mailed access to FIT and colonoscopy was associated with increased overall screening ( OR = 2.6 , P = 0.001 ) , due to a 29-fold increase in FIT use .


Telephone navigation was also associated with increased overall screening ( OR = 2.1 , P = 0.005 ) , mainly due to a 3-fold increase in colonoscopy performance .


We estimated that providing access and navigation for both screening tests may substantially increase screening compared with a preference-tailored approach , mainly due to increased performance of nonpreferred tests .


Preference influences the type of screening tests completed .


Test access increases FIT and navigation mainly increases colonoscopy .


Screening strategies providing access and navigation to both tests may be more effective than preference-tailored approaches .


Preference tailoring in colorectal cancer screening strategies should be avoided if the objective is to maximize screening rates , although other factors ( e.g. , costs , necessary follow-up ) should also be considered .


Appropriate sedation benefits patients by reducing the stress response , but it requires an appropriate method of assessment to adjust the dosage of sedatives .


The aim of this study was to compare the difference in the sedation of mechanically ventilated patients undergoing flexible bronchoscopy ( FB ) monitored by auditory-evoked potentials ( AEPs ) or the Ramsay sedation scale ( RSS ) .


In a prospective , randomized , controlled study , all patients who underwent FB with propofol sedation were monitored and their sedation adjusted .


During FB , one group was monitored by AEP and another group was monitored by RSS .


The propofol dosage was adjusted by the nursing staff during examination to maintain the Alaris AEP index ( AAI ) value between 25 and 40 in the AEP group and the RSS at 5 or 6 in the RSS group .


Before FB and during FB , the AAI , heart rate ( HR ) , and mean arterial pressure ( MAP ) were recorded every 5 min .


The percentages of time at the sedation target and the propofol dosages were calculated .


Nineteen patients received AEP monitoring and 18 patients received RSS monitoring .


The percentage of time at the sedation target during FB was significantly higher in the AEP monitoring group ( 51.3 % ; interquartile range [ IQR ] , 47.0-63 .5 % ) than in the RSS group ( 15.4 % ; IQR , 9.5-23 .4 % ) , ( P < 0.001 ) .


During FB , the RSS group had a significantly higher AAI ( P = 0.011 ) , HR ( P < 0.001 ) , and MAP ( P < 0.001 ) than the AEP group .


In mechanically ventilated patients undergoing FB , AEP monitoring resulted in less variation in AAI , HR , and MAP , and a higher percentage of time at the sedation target than RSS monitoring .


Given increasing rates of resistance to existing therapy , new options for treatment and prophylaxis of malaria are needed .


Two randomised , comparative , non-inferiority studies were conducted in Africa , one double-blinded and one open-label .


Adults with fever , a positive peripheral blood smear , and a positive rapid diagnostic test for Plasmodium falciparum were randomised in both studies to either azithromycin ( AZ ) 1,000 mg plus chloroquine ( CQ ) 600-mg base ( AZCQ 1,000 mg ) once daily for three days or mefloquine hydrochloride ( MQ ) 1,250 mg ( split dose ) .


In the first study , an additional regimen of AZ 500 mg plus CQ 600-mg base ( AZCQ 500 mg ) once daily for three days was included .


All study participants were hospitalised until three consecutive daily blood smears were negative for asexual P. falciparum parasitaemia .


Study participants were evaluated weekly for 42 days , with Day 28 polymerase chain reaction ( PCR ) - corrected parasitological clearance rate as primary endpoint .


A total of 467 subjects were randomised in the two studies .


At 28 days ' follow-up , PCR-corrected parasitological clearance rates in the per protocol population in the first study were 101/103 ( 98 % ) with AZCQ 1,000 mg compared with 102/103 ( 99 % ) with MQ ( 95 % confidence interval [ CI ] : -5.2 , 3.3 ) .


The AZCQ 500-mg regimen was stopped during an interim study review ( six [ 86 % ] clearance of seven evaluable ; two lost to follow-up ) .


In the second study , clearance rates were similar : AZCQ 1,000 mg 107/107 ( 100 % ) vs MQ 111/112 ( 99 % ; 95 % CI : -1.8 , 3.6 ) .


Among the participating countries , in vitro CQ resistance based on pfcrt mutation frequency in the baseline isolates across both studies ranged from 20.8 % ( Zambia ) to 96.1 % ( Uganda ) .


Serious adverse events ( AEs ; all causality ) were observed more frequently with MQ compared with AZCQ ( four vs one , respectively ) , though discontinuations for AEs were similar ( four vs three , respectively ) .


Common AEs in the AZ-containing arms included pruritus , vomiting , dizziness , and headache .


Among adults with symptomatic uncomplicated falciparum malaria in Africa , the combination of AZ 1,000 mg and CQ 600-mg base once daily for three days resulted in Day 28 PCR-corrected parasitological clearance rates of 98 % and was non-inferior to treatment with MQ .


AZCQ was well tolerated .


ClinicalTrials.gov identifiers NCT00082576 and NCT00367653 .


The phase 3 LUME-Lung 1 study assessed the efficacy and safety of docetaxel plus nintedanib as second-line therapy for non-small-cell lung cancer ( NSCLC ) .


Patients from 211 centres in 27 countries with stage IIIB/IV recurrent NSCLC progressing after first-line chemotherapy , stratified by ECOG performance status , previous bevacizumab treatment , histology , and presence of brain metastases , were allocated ( by computer-generated sequence through an interactive third-party system , in 1:1 ratio ) , to receive docetaxel 75 mg/m ( 2 ) by intravenous infusion on day 1 plus either nintedanib 200 mg orally twice daily or matching placebo on days 2-21 , every 3 weeks until unacceptable adverse events or disease progression .


Investigators and patients were masked to assignment .


The primary endpoint was progression-free survival ( PFS ) by independent central review , analysed by intention to treat after 714 events in all patients .


The key secondary endpoint was overall survival , analysed by intention to treat after 1121 events had occurred , in a prespecified stepwise order : first in patients with adenocarcinoma who progressed within 9 months after start of first-line therapy , then in all patients with adenocarcinoma , then in all patients .


This trial is registered with ClinicalTrials.gov , number NCT00805194 .


Between Dec 23 , 2008 , and Feb 9 , 2011 , 655 patients were randomly assigned to receive docetaxel plus nintedanib and 659 to receive docetaxel plus placebo .


The primary analysis was done after a median follow-up of 71 months ( IQR 38-110 ) .


PFS was significantly improved in the docetaxel plus nintedanib group compared with the docetaxel plus placebo group ( median 34 months [ 95 % CI 29-39 ] vs 27 months [ 26-28 ] ; hazard ratio [ HR ] 079 [ 95 % CI 068-092 ] , p = 00019 ) .


After a median follow-up of 317 months ( IQR 278-361 ) , overall survival was significantly improved for patients with adenocarcinoma histology who progressed within 9 months after start of first-line treatment in the docetaxel plus nintedanib group ( 206 patients ) compared with those in the docetaxel plus placebo group ( 199 patients ; median 109 months [ 95 % CI 85-126 ] vs 79 months [ 67-91 ] ; HR 075 [ 95 % CI 060-092 ] , p = 00073 ) .


Similar results were noted for all patients with adenocarcinoma histology ( 322 patients in the docetaxel plus nintedanib group and 336 in the docetaxel plus placebo group ; median overall survival 126 months [ 95 % CI 106-151 ] vs 103 months [ 95 % CI 86-122 ] ; HR 083 [ 95 % CI 070-099 ] , p = 00359 ) , but not in the total study population ( median 101 months [ 95 % CI 88-112 ] vs 91 months [ 84-104 ] ; HR 094 , 95 % CI 083-105 , p = 02720 ) .


Grade 3 or worse adverse events that were more common in the docetaxel plus nintedanib group than in the docetaxel plus placebo group were diarrhoea ( 43 [ 66 % ] of 652 vs 17 [ 26 % ] of 655 ) , reversible increases in alanine aminotransferase ( 51 [ 78 % ] vs six [ 09 % ] ) , and reversible increases in aspartate aminotransferase ( 22 [ 34 % ] vs three [ 05 % ] ) .


35 patients in the docetaxel plus nintedanib group and 25 in the docetaxel plus placebo group died of adverse events possibly unrelated to disease progression ; the most common of these events were sepsis ( five with docetaxel plus nintedanib vs one with docetaxel plus placebo ) , pneumonia ( two vs seven ) , respiratory failure ( four vs none ) , and pulmonary embolism ( none vs three ) .


Nintedanib in combination with docetaxel is an effective second-line option for patients with advanced NSCLC previously treated with one line of platinum-based therapy , especially for patients with adenocarcinoma .


Boehringer Ingelheim .


To investigate the effects of cell therapy on myocardial perfusion recovery after treatment of acute myocardial infarction ( MI ) with primary percutaneous coronary intervention ( PCI ) .


In this HEBE trial substudy , which was approved by the institutional review board ( trial registry number ISRCTN95796863 ) , the authors assessed the effects of intracoronary infusion with bone marrow-derived mononuclear cells ( BMMCs ) or peripheral blood-derived mononuclear cells ( PBMCs ) on myocardial perfusion recovery by using cardiac magnetic resonance ( MR ) imaging after revascularization .


In 152 patients with acute MI treated with PCI , cardiac MR imaging was performed after obtaining informed consent-before randomization to BMMC , PBMC , or standard therapy ( control group ) - and repeated at 4-month follow-up .


Cardiac MR imaging consisted of cine , rest first-pass perfusion , and late gadolinium enhancement imaging .


Perfusion was evaluated semiquantitatively with signal intensity-time curves by calculating the relative upslope ( percentage signal intensity change ) .


The relative upslope was calculated for the MI core , adjacent border zone , and remote myocardium .


Perfusion differences among treatment groups or between baseline and follow-up were assessed with the Wilcoxon signed rank or Mann-Whitney U test .


At baseline , myocardial perfusion differed between the MI core ( median , 6.0 % ; interquartile range [ IQR ] , 4.1 % -8.0 % ) , border zone ( median , 8.4 % ; IQR , 6.4 % -10.2 % ) , and remote myocardium ( median , 12.2 % ; IQR , 10.5 % -15.9 % ) ( P < .001 for all ) , with equal distribution among treatment groups .


These interregional differences persisted at follow-up ( P < .001 for all ) .


No difference in perfusion recovery was found between the three treatment groups for any region .


After revascularization of ST-elevation MI , cell therapy does not augment the recovery of resting perfusion in either the MI core or border zone .


The prevalence of Chronic Heart Failure ( CHF ) in Spain is very high .


It is the main cause of many hospital admissions and it is associated with high mortality rates .


Its management in Primary Care is not always adequate .


Our objective was to evaluate whether an educational intervention in general practitioners would improve the health care of their patients with chronic heart failure .


Prospective , randomised , and controlled study .


A structured formative course was given to the intervention group ( IG ) of practitioners .


A year later changes were compared with a control group ( CG ) .


The settings were two Primary Care Centres .


One of them was in a rural setting , and the other one with a mixture of rural and urban populations .


The study included 185 patients diagnosed with CHF , with a mean age of 79.8 years , and they were assigned to 20 practitioners ( Total population : 15 , 921 ) We evaluated the quality of medical history , clinical examination , laboratory tests and treatment .


At the end of the study there were marked differences between both groups .


In the IG , the Medical History improved 1.42 points ( 95 % CI : 0.57 to 2.28 ) , P = .001 .


The Clinical Examination improved 2.37 points ( 95 % CI : 1.10 to 3.65 ) , P > .001 and the Laboratory Tests , 0.75 points ( 95 % CI : -0.15 to 1.66 ) , P = .10 ; The Overall Difference was 5.44 points ( 95 % Cl : 3.25 to 7.62 ) , P > .001 .


There were slight improvements in Treatment .


The intervention promoted from our own work settings achieved a general improvement in the care of patients with heart failure .


To compare the effects of hyperbaric and isobaric bupivacaine spinal anesthesia on hemodynamics and heart rate variability ( HRV ) in nonobstetric surgery .


Sixty patients were randomly allocated to 2 groups .


Group I ( n = 30 ) received 15 mg ( 3 mL ) of hyperbaric bupivacaine and Group II ( n = 30 ) received 15 mg ( 3 mL ) of isobaric bupivacaine for spinal anesthesia .


Hemodynamic parameters were recorded before and after spinal anesthesia over 30 min .


Analyses of HRV were performed on the day of surgery , after volume loading , and 20 min after spinal injection .


Low frequency ( LF ) values , high frequency ( HF ) values , and LF/HF ratios were recorded .


The incidences of hypotension and alterations of HRV parameters in both groups were investigated .


The incidence ofhypotension was 26.6 % and 23.3 % in Groups I and II , respectively .


There were no significant differences in the LF and HF values and LF/HF ratios between groups .


In Group I , LF/HF ratios were significantly lower and HF values were significantly higher at 20 min after spinal anesthesia , in comparison to the baseline value ( P < 0.05 ) .


Hyperbaric bupivacaine caused a significantly greater decrease in LF/HF ratios and a significantly greater increase in HF values .


An association between relatively deep anesthesia , as guided by the bispectral index ( BIS ) , and increased postoperative mortality has been demonstrated in 6 of 8 published observational studies , but association does not necessarily mean causality .


Small clinical trials of anesthetic depth have demonstrated increased delirium and postoperative cognitive dysfunction in patients who were relatively deeply anesthetized , but have been inadequately powered to study mortality .


A large-scale randomized study is required to determine whether causality exists .


The primary hypothesis of our study is that `` light '' anesthesia , defined as a BIS target of 50 , will reduce all-cause mortality within 1 year of surgery in comparison with `` deep '' anesthesia , defined as a BIS target of 35 , in patients aged 60 years presenting for major surgery under general anesthesia .


The trial is an international multicenter , randomized , parallel-group , double-blind ( patients and investigators ) prospective , intention-to-treat , safety and efficacy study .


The relative reduction in mortality in the light anesthesia group is expected to be 20 % , giving an absolute risk reduction from 10 % to 8 % .


Power analysis using a = 0.049 and b = 0.2 indicates that 3250 patients are required in each group .


The study is underway , and 1325 patients have been recruited in 40 centers in 5 countries .


It is anticipated that the study will be completed in 3 years .


This randomized controlled trial should definitively answer the question of whether titrating anesthetic depth makes a difference to patient outcome in a vulnerable patient group .


The benefits of narrow band imaging ( NBI ) on enhancing colorectal adenoma detection remain questionable .


We tested whether the new generation of NBI ( 190-NBI ) , which is twice as bright as the previous version , would improve adenoma detection when compared with high-definition white light ( HD-WL ) colonoscopy .


It was a randomized controlled trial with tandem colonoscopy .


We recruited patients who underwent colonoscopy for symptoms , screening , or surveillance .


Patients were randomized for the use of either 190-NBI or HD-WL on withdrawal .


Tandem colonoscopy was performed by using the same assigned colonoscope and withdrawal method .


Lesions detected on first-pass and second-pass examination were used for adenoma detection and miss rates , respectively .


The primary outcomes were adenoma and polyp detection rates .


A total of 360 patients were randomized to undergo either 190-NBI or HD-WL colonoscopy .


Both the adenoma and polyp detection rates were significantly higher in the 190-NBI group compared with the HD-WL group ( adenoma : 48.3 % vs. 34.4 % , P = 0.01 ; polyps : 61.1 % vs. 48.3 % , P = 0.02 ) .


The mean number of polyps detected per patient was higher in the 190-NBI group ( 1.49 % vs. 1.13 , P = 0.07 ) .


There was no significant difference in the adenoma miss rates between the two groups ( 21.8 % vs. 21.2 % ) .


Multivariate analysis showed that the use of 190-NBI ( odds ratio ( OR ) 1.85 ; 95 % confidence interval ( CI ) 1.10-3 .12 ) , withdrawal time ( OR 1.29 ; CI 1.19-1 .38 ) , patient 's age ( OR 1.04 ; CI 1.01-1 .06 ) , and male gender ( OR 2.38 ; CI 1.42-3 .99 ) were associated with adenoma detection .


190-NBI colonoscopy was superior to the conventional HD-WL in detecting colorectal adenomas or polyps , but there was no significant difference in adenoma miss rates .


To compare the success rates of probing versus bicanalicular silastic intubation as the primary treatment for congenital nasolacrimal duct obstruction ( CNLDO ) in children 1year old .


Prospective , randomised , comparison .


Participants were randomised to undergo probing or bicanalicular silastic intubation .


In bilateral cases , the right eye was used for analysis .


The procedure was considered successful when all preoperative manifestations disappeared with normal dye disappearance test and a positive Jones primary dye test at least 6months postoperatively .


Secondary outcomes were risk factors for failure .


Outcomes were compared between treatments with p < 0.05 indicating statistical significance .


207 eyes of 181 children between 1 and 8years old with CNLDO who had not undergone previous surgical treatment were included in the study .


88 eyes underwent probing with a 84.1 % success rate and 93 eyes that underwent bicanalicular silastic intubation had a 89.2 % success rate ( p = 0.429 ) .


For simple CNLDO , there was a 94.2 % ( 65/69 ) success rate with probing and a 90.9 % ( 60/66 ) success rate with bicanalicular silastic intubation ( p = 0.687 ) .


In complex CNLDO , there was a 47.4 % ( 9/19 ; p = < 0.001 ) success rate with probing and an 85.2 % ( 23/27 ; p = 0.419 ) success rate with silastic intubation ( p = 0.016 ) .


Age was not a risk factor for failure in either procedure .


Probing for simple CNLDO in young children is adequate .


Bicanalicular silastic intubation seems to have a role in achieving successful outcomes in complex CNLDO .


Despite recommendations against systematic screening for prostate cancer , 70 % of patients still request prostate-specific antigen testing .


To assess the impact of a decision aid on patients ' intention to undergo prostate cancer screening .


Randomised controlled trial with two-arm parallel groups in 86 general practices in urban and rural areas in France .


Males aged 50-75 years were randomised to receive either the decision aid ( intervention group ) or usual care ( control group ) .


The primary outcome was the proportion of patients ' intending to undergo prostate cancer screening , assessed immediately after reading the decision aid .


The reasons underlying their choice were elicited and the proportion of patients citing each reason to undergo , or not undergo , prostate cancer screening were compared between the two arms .


A total of 1170 patients were randomised ( 588 in the intervention arm ) from November 2012 to February 2013 .


The proportion of patients who intended to be tested for prostate cancer in the intervention arm ( 123 patients [ 20.9 % ] ) was significantly reduced compared with the control arm ( 57 patients [ 9.8 % ] ) ( difference 11.1 % , 95 % confidence interval [ CI ] = 7.0 to 15.2 , P < 0.0001 ) .


In the intervention group , a lower proportion of individuals expressed that cancer screening would protect them from the disease , compared with the control group ( P < 0.0001 ) , while a greater proportion of individuals stated that prostate cancer screening would not benefit their health ( P < 0.0001 ) and may involve procedures with harmful side effects ( P = 0.0005 ) .


The decision aid improved participants ' informed decision making and reduced their intent to undergo prostate cancer screening .


To examine if supported employment ( SE ) remains more effective than treatment as usual ( TAU ) in returning veterans to competitive employment after spinal cord injury ( SCI ) at 2-year follow-up .


Prospective , randomized , controlled , multisite trial of SE versus TAU with 24 months of follow-up .


SCI centers .


Subjects ( N = 201 ) were enrolled and completed baseline interviews .


At interventional sites , subjects were randomized to SE ( n = 81 ) or TAU ( n = 76 ) .


At observational sites , 44 subjects were enrolled in a nonrandomized TAU condition .


The intervention was a SE program called the SCI Vocational Integration Program , which followed the principles of the individual placement and support model of SE for persons with mental illness .


Competitive employment in the community within 2 years .


For the entire 2-year follow-up period , SE subjects were significantly more likely to achieve employment ( 30.8 % ; 95 % confidence interval [ CI ] , 21.8-41 .6 ) than either the TAU subjects at the intervention sites ( 10.5 % ; 95 % CI , 5.2-19 .7 ; P < .001 ) or the TAU subjects at the observational sites ( 2.3 % ; 95 % CI , 0.0-12 .9 ; P < .002 ) .


Most subjects who obtained competitive employment did so in year 1 , and the average time to first employment was about 17 weeks .


SE was better than usual practices in improving employment outcomes for veterans with SCI across a 2-year follow-up period .


Although SE continued to be superior to traditional practices over the entire study , the first year of participation in SE may represent a critical window for achieving employment after SCI .


Our objective was to evaluate the effectiveness of hands-on training at a bedside ultrasound ( US ) symposium ( `` Ultrafest '' ) to improve both clinical knowledge and image acquisition skills of medical students .


Primary outcome measure was improvement in multiple choice questions on pulmonary or Focused Assessment with Sonography in Trauma ( FAST ) US knowledge .


Secondary outcome was improvement in image acquisition for either pulmonary or FAST .


Prospective cohort study of 48 volunteers at `` Ultrafest , '' a free symposium where students received five contact training hours .


Students were evaluated before and after training for proficiency in either pulmonary US or FAST .


Proficiency was assessed by clinical knowledge through written multiple-choice exam , and clinical skills through accuracy of image acquisition .


We used paired sample t-tests with students as their own controls .


Pulmonary knowledge scores increased by a mean of 10.1 points ( 95 % CI [ 8.9-11 .3 ] , p < 0.00005 ) , from 8.4 to a posttest average of 18.5 / 21 possible points .


The FAST knowledge scores increased by a mean of 7.5 points ( 95 % CI [ 6.3-8 .7 ] p < 0.00005 ) , from 8.1 to a posttest average of 15.6 / 21 .


We analyzed clinical skills data on 32 students .


The mean score was 1.7 pretest and 4.7 posttest of 12 possible points .


Mean improvement was 3.0 points ( p < 0.00005 ) overall , 3.3 ( p = 0.0001 ) for FAST , and 2.6 ( p = 0.003 ) for the pulmonary US exam .


This study suggests that a symposium on US can improve clinical knowledge , but is limited in achieving image acquisition for pulmonary and FAST US assessments .


US training external to official medical school curriculum may augment students ' education .


To evaluate the efficacy and safety of ramucirumab ( IMC-1121B ; LY3009806 ) , a fully human monoclonal antibody targeting the vascular endothelial growth factor receptor-2 , alone and in combination with dacarbazine in chemotherapy-nave patients with metastatic melanoma ( MM ) .


Eligible patients received ramucirumab ( 10mg/kg ) + dacarbazine ( 1000 mg/m ( 2 ) ) ( Arm A ) or ramucirumab only ( 10mg/kg ) ( Arm B ) every 3 weeks .


The primary end-point was progression-free survival ( PFS ) ; secondary end-points included overall survival ( OS ) , overall response and safety .


Of 106 randomised patients , 102 received study treatment ( Arm A , N = 52 ; Arm B , N = 50 ) .


Baseline characteristics were similar in both arms .


Median PFS was 2.6 months ( Arm A ) and 1.7 months ( Arm B ) ; median 6-month PFS rates were 30.7 % and 17.9 % and 12-month PFS rates were 23.7 % and 15.6 % , respectively .


In Arm A , 9 ( 17.3 % ) patients had partial response ( PR ) and 19 ( 36.5 % ) , stable disease ( SD ) ; PR and SD in Arm B were 2 ( 4.0 % ) and 21 ( 42.0 % ) , respectively .


Median OS was 8.7 months in Arm A and 11.1 months in Arm B. Patients in both arms tolerated the treatment with limited Grade 3/4 toxicities .


Ramucirumab alone or in combination with dacarbazine was associated with an acceptable safety profile in patients with MM .


Although the study was not powered for comparison between treatment arms , PFS appeared greater with combination therapy .


Sustained disease control was observed on both study arm .


Many programs emphasize subsequent pregnancy prevention and high school graduation among teenage mothers ; however , less is known about their ability to increase financial earnings from employment opportunities while concurrently enrolled in school .


This study evaluates factors influencing employment status among teenage mothers after enrolling in a community-based randomized intervention .


Project Mothers and Schools ( PMAS ) initiative participants were surveyed at baseline and 12 months after enrollment .


The 56 control group participants received homebound education and family case management , whereas the 59 intervention group participants received these basic-level services as well as group parenting time , life skills , and leadership training .


A generalized estimating equation was used to identify statistically significant changes associated with the intervention .


Participants were significantly more likely to receive money from their jobs at postintervention relative to baseline ( OR = 4.75 , p = .023 ) ; however , this change was not statistically significant when comparing the control group to the intervention group .


At postintervention , those who received money from parents were significantly less likely to receive money from their job ( OR = 0.12 , p = .002 ) .


While PMAS benefited participants in terms of employment , the role of parental support requires additional investigation to determine its influence on teenage mothers ' ability to achieve financial independence .


To evaluate the effect of two postnatal professional support interventions on the duration of any and exclusive breastfeeding .


Multicentre , three-arm , cluster randomised controlled trial .


A cohort of 722 primiparous breastfeeding mothers with uncomplicated , full-term pregnancies .


The three study interventions were : ( 1 ) standard postnatal maternity care ; ( 2 ) standard care plus three in-hospital professional breastfeeding support sessions , of 30-45minutes in duration ; or ( 2 ) standard care plus weekly post-discharge breastfeeding telephone support , of 20-30minutes in duration , for 4weeks .


The interventions were delivered by four trained research nurses , who were either highly experienced registered midwives or certified lactation consultants .


Prevalence of any and exclusive breastfeeding at 1 , 2 , and 3months postpartum .


Rates of any and exclusive breastfeeding were higher among participants in the two intervention groups at all follow-up points , when compared with those who received standard care .


Participants receiving telephone support were significantly more likely to continue any breastfeeding at 1month ( 76.2 versus 67.3 % ; odds ratio , OR1 .63 , 95 % confidence interval , 95 % CI 1.10-2 .41 ) and at 2months ( 58.6 versus 48.9 % ; OR1 .48 , 95 % CI 1.04-2 .10 ) , and to be exclusively breastfeeding at 1month ( 28.4 versus 16.9 % ; OR1 .89 , 95 % CI 1.24-2 .90 ) .


Participants in the in-hospital support group were also more likely to be breastfeeding at all time points , but the effect was not statistically significant .


Professional breastfeeding telephone support provided early in the postnatal period , and continued for the first month postpartum , improves breastfeeding duration among first-time mothers .


It is also possible that it was the continuing nature of the support that increased the effectiveness of the intervention , rather than the delivery of the support by telephone specifically .


Alcohol misuse among youth is a major public health concern and numbers of adolescents admitted to the emergency department for acute alcoholic intoxication in Germany are recently growing .


The emergency setting offers an opportunity to reach at-risk alcohol consuming adolescents and provide brief interventions in a potential `` teachable moment '' .


However , studies on brief interventions targeting adolescents in emergency care are scarce and little is known about their effectiveness when delivered immediately following hospitalization for acute alcohol intoxication .


In this protocol we present the HaLT-Hamburg trial evaluating a brief motivational intervention for adolescents treated in the emergency department after an episode of acute alcoholic intoxication .


The trial design is a parallel two-arm cluster randomized-controlled trial with follow-up assessment after 3 and 6 months .


N = 312 participants aged 17 years and younger will be recruited Fridays to Sundays in 6 pediatric clinics over a period of 30 months .


Intervention condition is a manual-based brief motivational intervention with a telephone booster after 6 weeks and a manual-guided intervention for caregivers which will be compared to treatment as usual .


Primary outcomes are reduction in binge drinking episodes , quantity of alcohol use on a typical drinking day and alcohol-related problems .


Secondary outcome is further treatment seeking .


Linear mixed models adjusted for baseline differences will be conducted according to intention-to-treat ( ITT ) and completers ( per-protocol ) principles to examine intervention effects .


We also examine quantitative and qualitative process data on feasibility , intervention delivery , implementation and receipt from intervention providers , receivers and regular emergency department staff .


The study has a number of strengths .


First , a rigorous evaluation of HaLT-Hamburg is timely because variations of the HaLT project are widely used in Germany .


Second , prior research has not targeted adolescents in the presumed teachable moment following acute alcohol intoxication .


Third , we included a comprehensive process evaluation to raise external validity .


Fourth , the study involved important stakeholders from the start to set up organizational structures for implementation and maintaining project impact .


Current Controlled Trials ISRCTN31234060 ( April 30th 2012 ) .


Paclitaxel drug-eluting balloons ( pDEB ) could be an attractive option to minimise side branch ( SB ) restenosis in bifurcated coronary lesions .


We compared angiographic and clinical outcomes with pDEB plus bare metal stent ( BMS ) versus drug-eluting stents ( DES ) in de novo bifurcated lesions .


This multicentre randomised trial included 108 patients .


Sequential main branch ( MB ) / SB dilatation with pDEB , with provisional T-stenting with BMS in the MB was performed in the pDEB group , and with everolimus DES in the DES group .


The primary endpoint was late lumen loss ( LLL ) at nine months .


The secondary endpoint was the incidence of major adverse cardiac events ( MACE : death , myocardial infarction , or target lesion revascularisation ) .


In-segment MB LLL was 0.310.48 mm in the pDEB group , and 0.160.38 mm in the DES group ( p = 0.15 ) ; mean difference was 0.15 mm ( upper limit one-sided 95 % CI : 0.27 mm ; p = 0.001 ; non-inferiority test ) .


LLL in SB was -0.040.76 mm in the pDEB group and -0.030.51 mm in the DES group ( p = 0.983 ) .


MACE and TLR were higher in the pDEB group ( 17.3 % vs. 7.1 % ; p = 0.105 , and 15.4 % vs. 3.6 % ; p = 0.045 ) , due to higher MB restenosis ( 13.5 % vs. 1.8 % ; p = 0.027 ) .


pDEB bifurcation pretreatment with BMS implantation in MB showed greater LLL ( ns ) and increased incidence of MACE compared to everolimus DES .


Both strategies showed similar results in the SB .


Women who deliver preterm infants are at a much greater risk for repeating a preterm birth ( PTB ) , compared to women without a history of PTB .


However , little is known about the prevalence of the risk factors which account for this markedly increased risk .


Moreover , little or nothing is known about the feasibility of providing treatments and services to these women , outside of the context of prenatal care , during the inter-conception period , which provides the best opportunity for successful risk-reduction interventions .


The Philadelphia Collaborative Preterm Prevention Project ( PCPPP ) , a large randomized control trial designed to identify and reduce six major risk factors for a repeat preterm birth among women immediately following the delivering of a preterm infant .


For the women assigned to the PCPPP treatment group , we calculated the prevalence of the six risk factors in question , the percentages of women who agreed to receive high quality risk-appropriate treatments or services , and the of rates of participation among those who were offered and eligible for these treatments or services .


Urogenital tract infections were identified in 57 % of the women , while 59 % were found to have periodontal disease .


More than 39 % were active smokers , and 17 % were assessed with clinical depression .


Low literacy , and housing instability were identified in , 22 and 83 % of the study sample , respectively .


Among women eligible for intervention , the percentages who accepted and at least minimally participated in treatment ranged from a low of 28 % for smoking , to a high of 85 % for urogenital tract infection .


Most PCPPP enrollees ( 57 % ) had three or more major risk factors .


Participation rates associated with the PCPPP treatments or services varied markedly , and were quite low in some cases , despite considerable efforts to reduce the barriers to receiving care .


The efficacy of individual level risk-reduction efforts designed to prevent preterm/repeat preterm in the pre - or inter-conception period may be limited if participation rates associated with interventions to reduce major risk factors for PTB are low .


Achieving adequate participation may require identifying , better understanding , and eliminating barriers to access , beyond those associated with cost , transportation , childcare , and service location or hours of operation .


ClinicalTrials.gov ( NCT01117922 ) .


Myoelectric prostheses use electromyographic ( EMG ) signals to control movement of prosthetic joints .


Clinically available myoelectric control strategies do not allow simultaneous movement of multiple degrees of freedom ( DOFs ) ; however , the use of implantable devices that record intramuscular EMG signals could overcome this constraint .


The objective of this study was to evaluate the real-time simultaneous control of three DOFs ( wrist rotation , wrist flexion/extension , and hand open/close ) using intramuscular EMG .


We evaluated task performance of five able-bodied subjects in a virtual environment using two control strategies with fine-wire EMG : ( i ) parallel dual-site differential control , which enabled simultaneous control of three DOFs and ( ii ) pattern recognition control , which required sequential control of DOFs .


Over the course of the experiment , subjects using parallel dual-site control demonstrated increased use of simultaneous control and improved performance in a Fitts ' Law test .


By the end of the experiment , performance using parallel dual-site control was significantly better ( up to a 25 % increase in throughput ) than when using sequential pattern recognition control for tasks requiring multiple DOFs .


The learning trends with parallel dual-site control suggested that further improvements in performance metrics were possible .


Subjects occasionally experienced difficulty in performing isolated single-DOF movements with parallel dual-site control but were able to accomplish related Fitts ' Law tasks with high levels of path efficiency .


These results suggest that intramuscular EMG , used in a parallel dual-site configuration , can provide simultaneous control of a multi-DOF prosthetic wrist and hand and may outperform current methods that enforce sequential control .


To simultaneously examine the effects of acute exercise intensity and free-living physical activity and sedentary behavior on cognitive function in young , healthy adults .


Using a counterbalanced , crossover , randomized controlled design , 87 young adults ( mean age , 21.4 years ) completed various cognitive assessments with and without an acute bout of exercise preceding the assessment .


Participants were randomized into 1 of 4 groups to complete a 30-minute bout of acute exercise : control ( no exercise ) , light intensity ( 40 % -50 % of predicted maximum heart rate [ HR ( max ) ] ) , moderate intensity ( 51 % -70 % of predicted HR ( max ) ) , or vigorous intensity ( 71 % -85 % of predicted HR ( max ) ) .


Subjectively and objectively determined ( accelerometry ) physical activity and sedentary behavior were assessed to examine the association between these free-living behaviors and cognitive function .


The study duration was August 26 , 2013 , to September 11 , 2014 .


Concentration-related cognition ( mean SD Feature Match test score ) was significantly higher after a 30-minute acute bout of moderate-intensity exercise ( 145.126.9 ) compared with cognitive assessment without exercise ( 121.319.2 ; P = .004 ) .


Furthermore , questionnaire-determined sedentary behavior was inversely associated with visual attention and task switching ( Trail Making Test A score ) ( = -0.23 ; P = .04 ) .


Last , estimated cardiorespiratory fitness ( volume of maximum oxygen consumption ) was positively associated with reasoning-related cognitive function ( Odd One Out test score ) ( = 0.49 ; P = .05 ) ; when adding metabolic equivalent of task minutes per week to this model , the results were not significant ( = 0.47 ; P = .07 ) .


These findings provide some support for acute moderate-intensity exercise , sedentary behavior , and cardiorespiratory fitness being associated with executive functioning-related cognitive function in young , healthy adults .


The purpose of this study was to assess the efficacy and safety of edivoxetine ( LY2216684 ) , a selective norepinephrine reuptake inhibitor , in pediatric patients with attention-deficit/hyperactivity disorder ( ADHD ) .


A fixed-dose , randomized , double-blind , 8 week study was conducted in patients 6-17 years of age , who were randomized by two strata : 1 ) Patients with prior stimulant use randomized to placebo , edivoxetine 0.1 mg/kg/day , 0.2 mg/kg/day , or 0.3 mg/kg/day arms in a 1:1:1:1 ratio ; 2 ) Stimulant-nave patients randomized to placebo , edivoxetine 0.1 mg/kg/day , 0.2 mg/kg/day , 0.3 mg/kg/day , or osmotic-release oral system methylphenidate ( OROS MPH ) ( 18-54mg / day based on body weight ) arms in a 1:1:1:1:1 ratio .


The primary efficacy measure was baseline-to-week 8 change of ADHD Rating Scale ( ADHD-RS ) total score for edivoxetine 0.2 mg/kg/day and 0.3 mg/kg/day .


A total of 340 patients were randomized to placebo ( n = 78 ) ; edivoxetine 0.1 mg/kg/day ( n = 76 ) , 0.2 mg/kg/day ( n = 75 ) , or 0.3 mg/kg/day ( n = 75 ) ; or OROS MPH ( n = 36 ) .


In the stimulant-nave stratum , the positive control , OROS MPH , was significantly superior to placebo in mean ADHD-RS total score change at end-point ( -19.46 , p = 0.015 ) .


The edivoxetine 0.2 mg/kg/day and 0.3 mg/kg/day arms had statistically significantly greater improvement than the placebo arm in mean ADHD-RS total score change at end-point ( placebo -10.35 ; edivoxetine 0.2 mg/kg/day -16.09 , p < 0.010 ; edivoxetine 0.3 mg/kg/day -16.39 , p < 0.010 ) and Clinical Global Impressions-Improvement score ( placebo 3.05 ; edivoxetine 0.1 mg/kg/day 3.01 , p = 0.860 ; edivoxetine 0.2 mg/kg/day 2.54 , p = 0.013 ; edivoxetine 0.3 mg/kg/day 2.53 , p = 0.013 ) .


In the overall efficacy-analyses data set ( n = 270 ) , the effect size estimates for edivoxetine doses 0.1 mg/kg/day , 0.2 mg/kg/day and 0.3 mg/kg/day at the week 8 time point were 0.17 , 0.51 , and 0.54 , respectively ( for the stimulant-nave stratum , the effect size estimate for OROS MPH was 0.69 ) .


Compared with placebo , edivoxetine treatment was associated with statistically significant increases in blood pressure and pulse ( p < 0.050 ) , and a smaller increase or slight decrease in weight .


Edivoxetine at doses of 0.2 mg/kg/day and 0.3 mg/kg/day demonstrated efficacy in ADHD treatment , despite the presence of a sizeable placebo response .


No unexpected adverse events were identified .


Clinical Trial Registry identifier : NCT00922636 .


To evaluate the relationship between number of metabolic syndrome ( MetS ) - like components and prostate cancer diagnosis in a group of men where nearly all biopsies were taken independent of prostate-specific antigen ( PSA ) level , thus minimising any confounding from how the various MetS-like components may influence PSA levels .


We analysed data from 6426 men in the Reduction by Dutasteride of Prostate Cancer Events ( REDUCE ) study with at least one on-study biopsy .


REDUCE compared dutasteride vs placebo on prostate cancer risk among men with an elevated PSA level and negative pre-study biopsy and included two on-study biopsies regardless of PSA level at 2 and 4 years .


Available data for MetS-like components included data on diabetes , hypertension , hypercholesterolaemia , and body mass index .


The association between number of these MetS-like components and prostate cancer risk and low-grade ( Gleason sum < 7 ) or high-grade ( Gleason sum > 7 ) vs no prostate cancer was evaluated using logistic regression .


In all , 2171 men ( 34 % ) had one MetS-like component , 724 ( 11 % ) had two , and 163 ( 3 % ) had three or four .


Men with more MetS-like components had lower PSA levels ( P = 0.029 ) .


One vs no MetS-like components was protective for overall prostate cancer ( P = 0.041 ) and low-grade prostate cancer ( P = 0.010 ) .


Two ( P = 0.69 ) or three to four ( P = 0.15 ) MetS-like components were not significantly related to prostate cancer .


While one MetS-like component was unrelated to high-grade prostate cancer ( P = 0.97 ) , two ( P = 0.059 ) or three to four MetS-like components ( P = 0.02 ) were associated with increased high-grade prostate cancer risk , although only the latter was significant .


When biopsies are largely PSA level independent , men with an initial elevated PSA level and a previous negative biopsy , and multiple MetS-like components were at an increased risk of high-grade prostate cancer , suggesting the link between MetS-like components and high-grade prostate cancer is unrelated to a lowered PSA level .


Qigong is highly favoured among Asian breast cancer survivors for enhancing health .


This study examined the hypothesis that quality of life ( QoL ) in the Qigong group is better than the placebo ( aerobic ) or usual care group .


A total of 197 participants were randomly assigned to either the 8-week Kuala Lumpur Qigong Trial or control groups in 2010-2011 .


Measurement taken at baseline and post - intervention included QoL , distress and fatigue .


Analysis of covariance ( ANCOVA ) and Kruskal Wallis were used to examine for differences between groups in the measurements .


There were 95 consenting participants in this 8week trial .


The adherence rates were 63 % for Qigong and 65 % for the placebo group .


The Qigong group showed significant marginal improvement in Quality of life scores compared to placebo ( mean difference = 7.3 unit ; p = 0.036 ) , compared to usual care ( mean difference = 6.7 unit ; p = 0.048 ) on Functional Assessment Cancer Therapy-Breast measure .


There were no significant changes between the placebo and usual care groups in fatigue or distress at post intervention ( 8-week ) .


Cancer survivors who participated in the Qigong intervention showed slightly better QOL .


Follow up studies are greatly needed to evaluate which subgroups may best benefit from Qigong .


With a steep rise of cancer survivors , there is an urgent need to explore and engage more cultural means of physical activity to fight side effects of treatment and for cancer control in developing countries .


Our goal was to evaluate the effect of breakfast size and composition on body weight , glycemic control , and metabolic markers in adults with type 2 diabetes mellitus ( T2DM ) .


59 overweight/obese adults with T2DM were randomized to one of two isocaloric diabetic diets for 3 months ; big breakfast ( BB ) , breakfast was rich in fat and protein and provided 33 % of total daily energy or small breakfast ( SB ) , breakfast was rich in carbohydrates and provided 12.5 % of total daily energy .


Although body weight was reduced similarly in both groups , the BB group showed greater HbA1c and systolic blood pressure reductions ( HbA1c : -4.62 % vs. -1.46 % , p = 0.047 ; SBP -9.58 vs. -2.43 mmHg ; p = 0.04 ) .


T2DM medication dose was reduced in a greater proportion of the BB participants ( 31 % vs. 0 % ; p = 0.002 ) while in the SB , a greater proportion of participants had a dose increases ( 16.7 % vs. 3.4 % ; p = 0.002 ) .


Hunger scores were lower in the BB group and greater improvements in fasting glucose were observed in the BB group .


A simple dietary manipulation enriching breakfast with energy as protein and fat appears to confer metabolic benefits and might be a useful alternative for the management of T2DM .


To evaluate the association between baseline comprehensive geriatric assessment ( CGA ) or the Groningen Frailty Indicator ( GFI ) and toxicity in elderly metastatic breast cancer ( MBC ) patients treated with first-line palliative chemotherapy .


MBC patients ( 65 years ) were randomized between pegylated liposomal doxorubicine or capecitabine .


CGA included instrumental activities of daily living ( IADL ) , cognition using the mini-mental state examination ( MMSE ) , mood using the geriatric depression scale ( GDS ) , comorbidity using the Charlson index , polypharmacy and nutritional status using the body mass index .


Frailty on CGA was defined as one or more of the following : IADL13 , MMSE23 , GDS5 , BMI20 , 5 medications or Charlson 2 .


The cut-off for frailty on the GFI was 4 .


Of the randomized 78 patients ( median age 75.5 years , range 65.8-86 .8 years ) , 73 were evaluable for CGA ; 52 ( 71 % ) had one or more geriatric conditions .


Grade 3-4 chemotherapy-related toxicity was experienced by 19 % of patients without geriatric conditions compared to 56 % of patients with two geriatric conditions and 80 % of those with three or more ( p = 0.002 ) .


Polypharmacy was the only individual factor significantly associated with toxicity ( p = 0.001 ) .


GFI had a sensitivity of 69 % and a specificity of 76 % for frailty on CGA , and was not significantly associated with survival or toxicity .


In this study of elderly patients with MBC , the number of geriatric conditions correlated with grade 3-4 chemotherapy-related toxicity .


Therefore , in elderly patients for whom chemotherapy is being considered , a CGA could be a useful addition to the decision-making process .


Hereditary haemochromatosis may result in severe organ damage which can be prevented by therapy .


We studied the possible advantages and disadvantages of erythrocytapheresis as compared with phlebotomy in patients with hereditary haemochromatosis .


In a prospective , randomised , open-label study , patients with hereditary haemochromatosis were randomised to bi-weekly apheresis or weekly whole blood phlebotomy .


Primary end-points were decrease in ferritin levels and transferrin saturation .


Secondary endpoints were decrease in haemoglobin levels , discomfort during the therapeutic procedure , costs and technicians ' working time .


Sixty-two patients were included .


Thirty patients were randomised to apheresis and 32 to whole blood phlebotomy .


Initially , ferritin levels declined more rapidly in the apheresis group , and the difference became statistically highly significant at 11 weeks ; however , time to normalisation of ferritin level was equal in the two groups .


We observed no significant differences in decline of transferrin saturation , haemoglobin levels or discomfort .


The mean cumulative technician time consumption until the ferritin level reached 50 g/L was longer in the apheresis group , but the difference was not statistically significant .


The cumulative costs for materials until achievement of the desired ferritin levels were three-fold higher in the apheresis group .


Treatment of hereditary haemochromatosis with erythrocytapheresis instead of whole blood phlebotomy results in a more rapid initial decline in ferritin levels and a reduced number of procedures per patient , but not in earlier achievement of target ferritin level .


The frequency of discomfort was equally low with the two methods .


The costs and , probably , technician time consumption were higher in the apheresis group .


SMOFlipid 20 % is intravenous lipid emulsion ( ILE ) containing long-chain triglycerides ( LCT ) , medium-chain triglycerides ( MCT ) , olive oil , and fish oil as a mixed emulsion containing - tocopherol .


The aim was to assess the efficacy of this new ILE in gastrointestinal surgery compared with MCT/LCT .


In this prospective study , 40 patients were randomized to SMOFlipid 20 % or MCT/LCT ( Lipovenoes 20 % ) group .


Clinical and biochemistry data were collected .


Inflammatory markers ( CRP , IL-6 , IL-10 , TNF - , TGF-1 ) and oxidative stress ( ROS and superoxide ) were measured .


Thirty-five patients ( 17 males and 18 females ) with a mean age of 57 years completed the study .


The patients ' demographic characteristics ( age , gender , height , body weight , and BMI ) were similar without significant differences between groups .


The increment of triglyceride on day 6 from baseline was significantly lower in SMOFlipid group than in Lipovenoes MCT/LCT group .


Inflammatory markers , as well as superoxide radical and total oxygen radical were not different between groups .


Despite the comparable effect on inflammatory response , because of its well-balanced fatty acid pattern , relatively low n-6 : n-3 ratio , and high vitamin E content , SMOFlipid had a better triglyceride-lowering effect as compared with MCT/LCT in adult patients undergoing gastrointestinal surgery .


To explore therapeutic effect and action mechanism of regulating spleen-stomach needling on diabetic nephropathy ( DN ) .


Using multi-centric , randomized , controlled and blind principles , 144 cases of DN were divided into an observation group and a control group according to random digital tab , 72 cases in each one .


Based on regular treatment of diabetes , the regulating spleen-stomach needling was applied at Zhongwan ( CV 12 ) , Quchi ( LI 11 ) , Hegu ( LI 4 ) and Xuehai ( SP 10 ) , etc. in the observation group while Shenshu ( BL 23 ) , Taixi ( KI 3 ) , Sanyinjiao ( SP 6 ) , Yanglingquan ( GB 34 ) , etc. were selected in the control group by reference of Acupuncture and moxibustion .


The treatment was given twice a day , six days as a treatment session with interval of one day between sessions .


Totally six weeks were required .


Changes of clinical symptoms and signs , fast blood glucose ( FBG ) , urinary albumin excretion rate ( UAER ) , beta2-microglobulin ( beta2-MG ) , monocyte chemotactic protein-1 ( MCP-1 ) , lymphocyte membrane cholesterol , propanediol ( MDA ) , PCO , 8-hydroxydeoxy guanosine ( 8-OHdG ) , superoxide dismutase ( SOD ) , CD3 + , CD4 + , CD8 + , and CD4 + / CD8 + were observed before and after treatment in two groups .


As for improving clinical symptoms and signs , total effective rate was 84.29 % ( 59/70 ) in the observation group and 55.56 % ( 40/72 ) in the control group , which had statistical difference between two groups ( P < 0.01 ) .


As for regulating glycometabolism [ ( 6.25 + / - 0.32 ) mmol/L vs ( 8.09 + / - 0.63 ) mmol/L ] , reducing UAER [ ( 154.43 + / - 55.14 ) mg/24h vs ( 268.91 + / - 77.65 ) mg/24h ] , restraining over-expression of MCP-1 [ ( 137.59 + / - 36.15 ) pg/mL vs ( 166.89 + / - 42.82 ) pg/mL ] , regulating level of oxidative stress , prohibiting oxidation of protein and adjusting quantity and activity of T lymphocyte subgroup , the observation group was superior to the control group ( P < 0.05 , P < 0.01 ) .


The regulating spleen-stomach needling is an effective method for treatment of DN , which cold improve glycometabolism disturbance-induced progressive kidney injury , recover glomerular filtration , reduce urinary albumin excretion rate , restrain overexpression of MCP-1 , adjust level of oxidative stress , prohibit oxidation of protein , increase protectiveness of membrane , adjust quantity and activity abnormity of T lymphocyte subgroup , leading to repairing lymphocyte damage and improving immune expression to delay kidney damage .


We investigated candidate genes associated with thiopurine metabolism and clinical response in childhood acute lymphoblastic leukemia .


We performed genome-wide SNP association studies of 6-thioguanine and 6-mercaptopurine cytotoxicity using lymphoblastoid cell lines .


We then genotyped the top SNPs associated with lymphoblastoid cell line cytotoxicity , together with tagSNPs for genes in the ` thiopurine pathway ' ( 686 total SNPs ) , in DNA from 589 Caucasian UK ALL97 patients .


Functional validation studies were performed by siRNA knockdown in cancer cell lines .


SNPs in the thiopurine pathway genes ABCC4 , ABCC5 , IMPDH1 , ITPA , SLC28A3 and XDH , and SNPs located within or near ATP6AP2 , FRMD4B , GNG2 , KCNMA1 and NME1 , were associated with clinical response and measures of thiopurine metabolism .


Functional validation showed shifts in cytotoxicity for these genes .


The clinical response to thiopurines may be regulated by variation in known thiopurine pathway genes and additional novel genes outside of the thiopurine pathway .


We performed a prospective , randomized , placebo-controlled study aimed to evaluate the efficacy and safety of a sedation protocol based on intranasal Ketamine and Midazolam ( INKM ) administered by a mucosal atomizer device in uncooperative children undergoing gastric aspirates for suspected tuberculosis .


evaluation of Modified Objective Pain Score ( MOPS ) reduction in children undergoing INKM compared to the placebo group .


evaluation of safety of INKM protocol , start time sedation effect , duration of sedation and evaluation of parents and doctors ' satisfaction about the procedure .


In the sedation group , 19 children , mean age 41.5 months , received intranasal Midazolam ( 0.5 mg/kg ) and Ketamine ( 2 mg/kg ) .


In the placebo group , 17 children received normal saline solution twice in each nostril .


The child 's degree of sedation was scored using the MOPS .


A questionnaire was designed to evaluate the parents ' and doctors ' opinions on the procedures of both groups .


Fifty-seven gastric washings were performed in the sedation-group , while in the placebo-group we performed 51 gastric aspirates .


The degree of sedation achieved by INMK enabled all procedures to be completed without additional drugs .


The mean duration of sedation was 71.5 min .


Mean MOPS was 3.5 ( range 1-8 ) in the sedation-group , 7.2 ( range 4-9 ) in the placebo-group ( p < 0.0001 ) .


The questionnaire revealed high levels of satisfaction by both doctors and parents in the sedation-group compared to the placebo-group .


The only side effect registered was post-sedation agitation in 6 procedures in the sedation group ( 10.5 % ) .


Our experience suggests that atomized INKM makes gastric aspirates more acceptable and easy to perform in children .


Unique trial Number : UMIN000010623 ; Receipt Number : R000012422 .


To determine the optimal method for use of the Canine Brief Pain Inventory ( CBPI ) to quantitate responses of dogs with osteoarthritis to treatment with carprofen or placebo .


150 dogs with osteoarthritis .


Data were analyzed from 2 studies with identical protocols in which owner-completed CBPIs were used .


Treatment for each dog was classified as a success or failure by comparing the pain severity score ( PSS ) and pain interference score ( PIS ) on day 0 ( baseline ) with those on day 14 .


Treatment success or failure was defined on the basis of various combinations of reduction in the 2 scores when inclusion criteria were set as a PSS and PIS 1 , 2 , or 3 at baseline .


Statistical analyses were performed to select the definition of treatment success that had the greatest statistical power to detect differences between carprofen and placebo treatments .


Defining treatment success as a reduction of 1 in PSS and 2 in PIS in each dog had consistently robust power .


Power was 62.8 % in the population that included only dogs with baseline scores 2 and 64.7 % in the population that included only dogs with baseline scores 3 .


The CBPI had robust statistical power to evaluate the treatment effect of carprofen in dogs with osteoarthritis when protocol success criteria were predefined as a reduction 1 in PIS and 2 in PSS .


Results indicated the CBPI can be used as an outcome measure in clinical trials to evaluate new pain treatments when it is desirable to evaluate success in individual dogs rather than overall mean or median scores in a test population .


Two once-daily long-acting muscarinic antagonists ( LAMAs ) are currently available for the treatment of chronic obstructive pulmonary disease ( COPD ) - tiotropium and glycopyrronium .


Previous studies have compared glycopyrronium with open-label tiotropium .


In the GLOW5 study , we compare glycopyrronium with blinded tiotropium .