Analyses substituting 5 % of energy from fat by protein showed that weight gain would decrease by 72 g/month ( 95 % CI , 6 to 140 ; p = .03 ) ; substituting 5 % of energy from carbohydrate by protein decreased gain by 70 g/month ( 95 % CI , 15 to 124 ; p = .01 ) .


Baseline BMI did not modify these associations .


Further research on the effects of macronutrient composition on gestational weight gain is needed to inform the design of supplementation programs for women in developing countries .


Implementation of self-management support in traditional primary care settings has proved difficult , encouraging the development of alternative models which actively link to community resources .


Chronic kidney disease ( CKD ) is a common condition usually diagnosed in the presence of other co-morbidities .


This trial aimed to determine the effectiveness of an intervention to provide information and telephone-guided access to community support versus usual care for patients with stage 3 CKD .


In a pragmatic , two-arm , patient level randomised controlled trial 436 patients with a diagnosis of stage 3 CKD were recruited from 24 general practices in Greater Manchester .


Patients were randomised to intervention ( 215 ) or usual care ( 221 ) .


Primary outcome measures were health related quality of life ( EQ-5D health questionnaire ) , blood pressure control , and positive and active engagement in life ( heiQ ) at 6 months .


At 6 months , mean health related quality of life was significantly higher for the intervention group ( adjusted mean difference = 0.05 ; 95 % CI = 0.01 , 0.08 ) and blood pressure was controlled for a significantly greater proportion of patients in the intervention group ( adjusted odds-ratio = 1.85 ; 95 % CI = 1.25 , 2.72 ) .


Patients did not differ significantly in positive and active engagement in life .


The intervention group reported a reduction in costs compared with control .


An intervention to provide tailored information and telephone-guided access to community resources was associated with modest but significant improvements in health related quality of life and better maintenance of blood pressure control for patients with stage 3 CKD compared with usual care .


However , further research is required to identify the mechanisms of action of the intervention .


Controlled-Trials .


com ISRCTN45433299 .


To evaluate the efficacy and tolerability of a furazolidone-based quadruple rescue regimen in patients with previously failed Helicobacter pylori ( H.pylori ) eradication treatment .


A total of 156 patients were recruited from July 2011 to June 2013 at Beijing Hospital and randomized into one of the following 10-day treatment regimens : ( 1 ) Esomeprazole 20 mg twice daily , furazolidone 100 mg twice daily , amoxicillin 1000 mg twice daily , bismuth salts 150 mg thrice daily for 10 days .


( 2 ) Esomeprazole 20 mg twice daily , levofloxacin 500 mg daily , amoxicillin 1000 mg twice daily , bismuth salts 150 mg thrice daily for 10 days .


H.pylori status was re-assessed with the ( 13 ) C-urea breath test at 4 weeks after the end of therapy .


The intention-to-treat ( ITT ) and per-protocol ( PP ) H.pylori eradication rates were 83.8 % ( 67/80 ) and 88.2 % ( 67/76 ) in the furazolidone-based quadruple group , and 69.7 % ( 53/76 ) and 73.6 % ( 53/72 ) in the levofloxacin-based quadruple group respectively ( ( 2 ) = 4.311 , 5.100 ; P = 0.038 , 0.024 ) .


The 10-day furazolidone-based quadruple therapy is an efficacious rescue strategy in patients with previously failed eradication therapy .


TETRA ( terrestrial trunked radio ) is a digital radio communication standard , which has been implemented in several European countries and is used by public executives , transportation services , and by private companies .


Studies on possible impacts on the users ' health considering different exposure conditions are missing .


To investigate possible acute effects of electromagnetic fields ( EMF ) of two different levels of TETRA hand-held transmitter signals on cognitive function and well-being in healthy young males .


In the present double-blind cross-over study possible effects of short-term ( 2.5 h ) EMF exposure of handset-like signals of TETRA ( 385 MHz ) were studied in 30 healthy male participants ( meanSD : 25.42.6 years ) .


Individuals were tested on nine study days , on which they were exposed to three different exposure conditions ( Sham , TETRA 1.5 W/kg and TETRA 6.0 W/kg ) in a randomly assigned and balanced order .


Participants were tested in the afternoon at a fixed timeframe .


Attention remained unchanged in two out of three tasks .


In the working memory significant changes were observed in two out of four subtasks .


Significant results were found in 5 out of 35 tested parameters , four of them led to an improvement in performance .


Mood , well-being and subjective somatic complaints were not affected by TETRA exposure .


The results of the present study do not indicate a negative impact of a short-term EMF-effect of TETRA on cognitive function and well-being in healthy young men .


Theory suggests the uptake of a medical innovation is influenced by how potential adopters perceive innovation characteristics and by characteristics of potential adopters .


Innovation adoption is slow among the first 20 % of individuals in a target group and then accelerates .


The Quality Initiative in Rectal Cancer ( QIRC ) trial assessed if rectal cancer surgery outcomes could be improved through surgeon participation in the QIRC strategy .


We tested if traditional uptake of innovation concepts applied to surgeons in the experimental arm of the trial .


The QIRC strategy included workshops , access to opinion leaders , intraoperative demonstrations , postoperative questionnaires , and audit and feedback .


For intraoperative demonstrations , a participating surgeon invited an outside surgeon to demonstrate optimal rectal surgery techniques .


We used surgeon timing in a demonstration to differentiate early and late adopters of the QIRC strategy .


Surgeons completed surveys on perceptions of the strategy and personal characteristics .


Nineteen of 56 surgeons ( 34 % ) requested an operative demonstration on their first case of rectal surgery .


Early and late adopters had similar perceptions of the QIRC strategy and similar characteristics .


Late adopters were less likely than early adopters to perceive an advantage for the surgical techniques promoted by the trial ( p = 0.023 ) .


Most traditional diffusion of innovation concepts did not apply to surgeons in the QIRC trial , with the exception of the importance of perceptions of comparative advantage .


Target temperature management is recommended as a neuroprotective strategy after out-of-hospital cardiac arrest .


Potential effects of different target temperatures on cognitive impairment commonly described in survivors have not been investigated sufficiently .


The primary aim of this study was to evaluate whether a target temperature of 33C compared with 36C was favorable for cognitive function ; the secondary aim was to describe cognitive impairment in cardiac arrest survivors in general .


Study sites included 652 cardiac arrest survivors originally randomized and stratified for site to temperature control at 33C or 36C within the Target Temperature Management trial .


Survival until 180 days after the arrest was 52 % ( 33C , n = 178/328 ; 36C , n = 164/324 ) .


Survivors were invited to a face-to-face follow-up , and 287 cardiac arrest survivors ( 33C , n = 148/36C , n = 139 ) were assessed with tests for memory ( Rivermead Behavioural Memory Test ) , executive functions ( Frontal Assessment Battery ) , and attention/mental speed ( Symbol Digit Modalities Test ) .


A control group of 119 matched patients hospitalized for acute ST-segment-elevation myocardial infarction without cardiac arrest performed the same assessments .


Half of the cardiac arrest survivors had cognitive impairment , which was mostly mild .


Cognitive outcome did not differ ( P > 0.30 ) between the 2 temperature groups ( 33C/36C ) .


Compared with control subjects with ST-segment-elevation myocardial infarction , attention/mental speed was more affected among cardiac arrest patients , but results for memory and executive functioning were similar .


Cognitive function was comparable in survivors of out-of-hospital cardiac arrest when a temperature of 33C and 36C was targeted .


Cognitive impairment detected in cardiac arrest survivors was also common in matched control subjects with ST-segment-elevation myocardial infarction not having had a cardiac arrest .


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


Unique identifier : NCT01946932 .


Genital warts are caused by human papillomavirus infection and represent one of the most common sexually transmitted diseases .


Many infections are transient but the virus may recur , persist , or become latent .


To date , there is no effective antiviral treatment to eliminate HPV infection and most therapies are aimed at the destruction of visible lesions .


Potassium hydroxide is a strong alkali that has been shown to be safe and effective for the treatment of genital warts and molluscum contagiosum .


Cryotherapy is considered one of the most established treatments for genital warts .


No comparative trials have been reported to date on the use of potassium hydroxide for genital warts .


A prospective , open-label , randomized clinical trial was conducted to compare topical potassium hydroxide versus cryotherapy in the treatment of genital warts affecting immunocompetent , sexually active men .


Over a period of 10 months , 48 patients were enrolled .


They were randomly divided into two groups and selected on an alternative basis for either potassium hydroxide therapy or cryotherapy .


While response to therapy did not differ substantially between both treatment modalities , side effects such as local pain and post-treatment hypopigmentation were considerably more prevalent in the groups treated using cryotherapy .


In our study , potassium hydroxide therapy proved to be at least as effective as cryotherapy and offered the benefit of a better safety profile .


Topical 5 % potassium hydroxide presents an effective , safe , and low-cost treatment modality for genital warts in men and should be included in the spectrum of therapies for genital warts .


Hallux valgus with an increased intermetatarsal angle is usually treated with a proximal metatarsal osteotomy .


The proximal chevron osteotomy is commonly used but is technically difficult .


This study compares the proximal opening wedge osteotomy of the first metatarsal with the proximal chevron osteotomy for the treatment of hallux valgus with an increased intermetatarsal angle .


This prospective , randomized multicenter ( three-center ) study was based on the clinical outcome scores of the Short Form-36 , the American Orthopaedic Foot & Ankle Society forefoot questionnaire , and the visual analog scale for pain , activity , and patient satisfaction .


Subjects were assessed prior to surgery and at three , six , and twelve months postoperatively .


Surgeon preference was evaluated based on questionnaires and the operative times required for each procedure .


No significant differences were found for any of the patients ' clinical outcome measurements between the two procedures .


The proximal opening wedge osteotomy was found to lengthen , and the proximal chevron osteotomy was found to shorten , the first metatarsal .


The intermetatarsal angles improved ( decreased ) significantly , from 14.8 3.2 to 9.1 2.9 ( mean and standard deviation ) after a proximal opening wedge osteotomy and from 14.6 3.9 to 11.3 4.0 after a proximal chevron osteotomy ( p < 0.05 for both ) .


Operative time required for performing a proximal opening wedge osteotomy is similar to that required for performing a proximal chevron osteotomy ( mean and standard deviation , 67.1 16.5 minutes compared with 69.9 18.6 minutes ; p = 0.510 ) .


Opening wedge and proximal chevron osteotomies have comparable radiographic outcomes and comparable clinical outcomes for pain , satisfaction , and function .


The proximal opening wedge osteotomy lengthens , and the proximal chevron osteotomy shortens , the first metatarsal .


The proximal opening wedge osteotomy was subjectively less technically demanding and was preferred by the orthopaedic surgeons in this study .


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .


The recent SHARP trial clearly demonstrated that a reduction in low-density lipoprotein ( LDL ) cholesterol with a daily regimen of simvastatin plus ezetimibe safely reduced the incidence of major atherosclerotic events in patients with chronic kidney disease ( CKD ) .


We aimed to compare the efficacy of and adverse effects from statin uptitration versus statin in combination with ezetimibe since only a few studies have addressed this question .


This was a randomized , open-label , multicenter trial that included 286 patients with CKD whose LDL cholesterol levels were not reduced below 120 mg/dl despite a minimum dose of statin therapy .


Patients received double doses of statin or usual statin dose with the addition of ezetimibe 10 mg daily .


The observation period was 1 year during which time patients were checked regularly in clinic for adverse effects as well as for usual laboratory examinations .


The key prespecified outcome was the incidence of adverse effects , which included skeletal muscle complaints , myalgia , muscle weakness , and muscle cramps with and without elevated CK levels .


Increases in alanine transaminase ( ALT ) or aspartate transaminase ( AST ) levels > 2 times the upper limit of normal ( ULN ) were considered clinically significant adverse effects .


Adverse events occurred in 9/145 in the combination group and in 24/141 in the statin uptitration group ( p < 0.01 ) .


Moreover , in patients with CKD of stages 3-5 , rates were 6/58 in the combination group versus 20/52 in the statin uptitration group ( p < 0.01 ) .


No serious adverse effects such as rhabdomyolysis were noted in either group .


Serum creatinine levels remained essentially unchanged in both groups except in CKD stages 4 and 5 .


Reductions in LDL cholesterol were similar between the two groups at the start of and at the end of the study .


During the study , no atherosclerotic events were reported in either group .


When statin uptitration produces adverse effects such as myopathy , combination therapy with ezetimibe is recommended instead of statin alone .


Family-based treatment models that have shown effectiveness with juvenile offenders may also lead to reduced criminality in siblings of those offenders .


However , the lasting effects of such treatments on siblings have not been evaluated .


In the present study , the authors examined criminal outcomes for siblings of serious and violent juvenile offenders who had participated on average 25.0 years earlier in a clinical trial of multisystemic therapy ( MST ; Borduin et al. , 1995 ) .


Participants were 129 closest-in-age siblings of individuals who were originally randomized to MST or individual therapy ( IT ) during adolescence .


Arrest and incarceration data were obtained in middle adulthood when siblings were on average 38.4 years old .


Intent-to-treat analyses showed that arrest rates were significantly lower for siblings in the MST condition than in the IT condition ( 43.3 % vs. 72.0 % , respectively ) .


In addition , siblings in the IT condition were about 3 times as likely to be convicted of a felony and more than twice as likely to be sentenced to incarceration and probation .


The present study represents the longest follow-up to date of sibling participants in an MST clinical trial and demonstrates that the positive impact of an evidence-based treatment for serious and violent juvenile offenders can extend to other family members .


Implications of the authors ' findings for policymakers and service providers are discussed .


Community-acquired bacterial meningitis ( CABM ) is a life-threatening condition that is common among immunocompromised individuals .


Intravenous ceftriaxone , of which Rocephin ( ROC ) is the originator brand , is recommended as first-line therapy in South Africa .


Despite concerns regarding therapeutic equivalence with generic agents , this is the first study that has been conducted comparing clinical pharmacokinetics ( PK ) of a generic ceftriaxone formulation with the originator .


To compare the PK and safety of Aspen Ceftriaxone ( AC ) and ROC in the treatment of adult CABM.Methods .


A total of 63 eligible patients were randomised 1:1 to receive 2 g of either medication twice daily for a duration based on the identity of the causative organism and their physician 's clinical judgment .


The primary endpoint of this study was the comparison of clinical PK , specifically the concentrations of each drug in the cerebrospinal fluid with corresponding paired plasma samples .


While this study was underpowered to assess efficacy , safety could be evaluated on the basis of reported adverse events .


The two patient groups were epidemiologically similar .


There were no statistically significant differences in PK between either agent , nor any difference with regard to safety .


AC can be considered as equivalent to ROC with regard to PK and safety in patients with CABM .


Although self-efficacy ( SE ) and outcome expectancy ( OE ) have been well researched as predictors of outcome , few studies have investigated changes in these variables across treatments .


We evaluated changes in OE and SE throughout treatment as predictors of outcomes in a large sample with panic disorder , generalized anxiety disorder , social anxiety disorder , or posttraumatic stress disorder .


We hypothesized that increases in SE and OE would predict reductions in anxiety and depression as well as improvement in functioning .


Participants ( mean age = 43.3 years , SD = 13.2 , 71.1 % female , 55.5 % white ) were recruited from primary care centers throughout the United States and were randomized to receive either Coordinated Anxiety Learning and Management ( CALM ) treatment - composed of cognitive behavioral therapy , psychotropic medication , or both - or usual care .


SE and OE ratings were collected at each session for participants in the CALM treatment ( n = 482 ) and were entered into a structural equation model as predictors of changes in Brief Symptom Inventory , Anxiety Sensitivity Index , Patient Health Questionnaire ( PHQ ) , and Sheehan Disability Scale outcomes at 6 , 12 , and 18 months after baseline .


The best-fitting models predict symptom levels from OE and SE and not vice versa .


The slopes and intercept of OE significantly predicted change in each outcome variable except PHQ-8 .


The slope and intercept of SE significantly predicted change in each outcome variable .


Over and above absolute level , increases in SE and OE were significant predictors of decreases in symptoms and increases in functioning .


Implications for treatment are discussed , as well as future directions of research .


To compare the efficacy of pelvic floor muscle exercise with the concentration therapy versus pelvic floor muscle exercise alone after radical prostatectomy .


One hundred thirty five patients were randomized into the intervention group that concentration therapy was added to Kegel exercise , and control group that was Kegel exercise only , using the stratified randomization ( stratified by taking the catheter off before and after discharge ) and type of surgery .


Incontinence was defined as a loss of urine equal or more than to 2 grams in one-hour pad test , before and after the test in each sample group .


Follow-up results were obtained by phone visit at 3 , 4 , 5 , 6 , 8 , 10 , and 12 weeks after surgery


In the intervention group , 65 of 68 cases ( 95.6 % ) had continence in three months , compared to 48 of 67 ( 71.6 % ) in the control group , with significant statistical difference ( p-value < 0.001 ) .


The secondary result was the regularity in practicing .


It was 80 % in total .


In the intervention group , 66 of 68 cases ( 97.06 % ) practiced compared to 34 of 67 ( 50.75 % ) in the control group , which was significant difference between the two groups .


Combined concentration therapy with Kegel exercise had significantly improved continence after radical prostatectomy


The purpose of this study was to determine the influence of self-tapping and self-drilling placement techniques on the stability of miniscrews .


We included 70 orthodontic patients who received miniscrews ( 140 screws ) .


Miniscrews measuring 1.6 mm in diameter and 8 mm in length were placed using the self-tapping ( 35 patients , 70 screws ) and self-drilling ( 35 patients , 70 screws ) methods .


We examined the success rates , placement torque values , Periotest ( Medizintechnik Gulden , Bensheim , Germany ) values , rates of root contact , and influence of root contact on mobility .


Cone-beam computed tomography was used to evaluate root contact .


Miniscrews that endured an orthodontic force for 6 months or more were considered successful .


The success rates of the miniscrews were approximately 96 % with either placement technique .


The placement torques were 7 and 7.5 N cm in the self-tapping and self-drilling miniscrews , respectively ( P > 0.05 ) .


The Periotest values of the self-drilling method were significantly greater than those of the self-tapping method .


The Periotest values of the self-drilling miniscrews with root contact were significantly greater than those with no root contact .


Both placement techniques showed high stability in the maxillary bone , although the self-drilling miniscrews with root contact had greater mobility .


Special attention to root contact further improves the stability of the self-drilling miniscrews .


Treatment options for wild-type BRAF melanoma patients remain limited .


Selumetinib , a MEK 1/2 inhibitor , suppresses pERK levels independent of BRAF and NRAS mutation status , and combination with docetaxel has demonstrated synergy in xenograft models .


The aim of this study was to assess the efficacy and safety of selumetinib plus docetaxel as first-line treatment in patients with wild-type BRAF advanced melanoma .


In this double-blind multicentre phase II trial patients with wild-type BRAF melanoma were randomized ( 1:1 ) to docetaxel with selumetinib or placebo .


Docetaxel 75 mg/m ( 2 ) was administered intravenously every 3 weeks up to six cycles .


Selumetinib 75 mg or placebo was given orally twice daily until disease progression or unacceptable toxicity .


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


Tumour NRAS mutation status was analysed retrospectively and correlated with treatment outcomes .


Eighty-three patients were randomized to docetaxel plus selumetinib ( n = 41 ) or docetaxel plus placebo ( n = 42 ) .


The PFS hazard ratio ( HR ) ( selumetinib : placebo ) was 0.75 [ 90 % confidence interval ( CI ) 0.50-1 .14 ; P = 0.130 ] , with a median PFS of 4.23 months ( 90 % CI 3.63-6 .90 ) for docetaxel plus selumetinib and 3.93 months ( 90 % CI 2.07-4 .16 ) for docetaxel alone .


There was no significant difference in overall survival .


The objective response rate was 32 % with selumetinib versus 14 % with placebo ( P = 0.059 ) .


In a retrospective subset analysis , NRAS mutation status did not affect significantly upon clinical outcomes in either arm .


The combination of docetaxel and selumetinib could be administered effectively to patients with metastatic melanoma , although the combination was less well tolerated than docetaxel alone .


The combination of docetaxel with selumetinib showed no significant improvement in PFS compared with docetaxel alone , although more patients showed a response to combination therapy .


We found no evidence to support using tumour NRAS mutation as a basis for selecting patients for combined MEK inhibitor and chemotherapy .


DOC-MEK ( EudraCT no : 2009-018153-23 ) .


Cesarean delivery may reduce placental-fetal transfusion and thus increase the risk of early childhood anemia compared with vaginal delivery , but this notion has not been carefully studied in longitudinal cohorts .


The aim was to assess the association of cesarean delivery with anemia in infants and children in 2 longitudinal Chinese birth cohorts from different socioeconomic settings .


Cohort 1 was recruited from 5 counties in northeastern China and cohort 2 from 21 counties or cities in southeastern China .


Cohort 1 involved 17,423 infants born during 2006-2009 to mothers with early pregnancy baseline hemoglobin concentrations ranging from 100 to 177 g/L , whereas cohort 2 involved 122,777 children born during 1993-1996 to mothers with baseline hemoglobin concentrations ranging from 60 to 190 g/L .


The main outcomes were anemia at 6 and 12 mo in cohort 1 and at 58 mo in cohort 2 .


Multiple logistic regressions were used to estimate adjusted ORs of anemia for cesarean compared with vaginal delivery .


Stratified analyses were performed by pre - and postlabor cesarean delivery and according to maternal baseline hemoglobin concentration ( 109 , 110-119 , 120-129 , and 130 g/L ) .


Cesarean delivery was not associated with anemia at 6 mo in cohort 1 ( adjusted OR : 1.05 ; 95 % CI : 0.93 , 1.19 ) ; however , cesarean delivery was associated with increased anemia at 12 mo in cohort 1 ( adjusted OR : 1.19 ; 95 % CI : 1.04 , 1.37 ) and at 58 mo in cohort 2 ( adjusted OR : 1.11 ; 95 % CI : 1.08 , 1.15 ) .


The positive associations for anemia at 12 and 58 mo were consistent across maternal hemoglobin subgroups and persisted for cesarean delivery subtypes .


Cesarean delivery is likely associated with anemia in children , which suggests a possible need for exploring changes in obstetric care that might prevent anemia in cesarean-delivered children .


Nivolumab ( a programmed death 1 [ PD-1 ] checkpoint inhibitor ) and ipilimumab ( a cytotoxic T-lymphocyte-associated antigen 4 [ CTLA-4 ] checkpoint inhibitor ) have been shown to have complementary activity in metastatic melanoma .


In this randomized , double-blind , phase 3 study , nivolumab alone or nivolumab plus ipilimumab was compared with ipilimumab alone in patients with metastatic melanoma .


We assigned , in a 1:1:1 ratio , 945 previously untreated patients with unresectable stage III or IV melanoma to nivolumab alone , nivolumab plus ipilimumab , or ipilimumab alone .


Progression-free survival and overall survival were coprimary end points .


Results regarding progression-free survival are presented here .


The median progression-free survival was 11.5 months ( 95 % confidence interval [ CI ] , 8.9 to 16.7 ) with nivolumab plus ipilimumab , as compared with 2.9 months ( 95 % CI , 2.8 to 3.4 ) with ipilimumab ( hazard ratio for death or disease progression , 0.42 ; 99.5 % CI , 0.31 to 0.57 ; P < 0.001 ) , and 6.9 months ( 95 % CI , 4.3 to 9.5 ) with nivolumab ( hazard ratio for the comparison with ipilimumab , 0.57 ; 99.5 % CI , 0.43 to 0.76 ; P < 0.001 ) .


In patients with tumors positive for the PD-1 ligand ( PD-L1 ) , the median progression-free survival was 14.0 months in the nivolumab-plus-ipilimumab group and in the nivolumab group , but in patients with PD-L1-negative tumors , progression-free survival was longer with the combination therapy than with nivolumab alone ( 11.2 months [ 95 % CI , 8.0 to not reached ] vs. 5.3 months [ 95 % CI , 2.8 to 7.1 ] ) .


Treatment-related adverse events of grade 3 or 4 occurred in 16.3 % of the patients in the nivolumab group , 55.0 % of those in the nivolumab-plus-ipilimumab group , and 27.3 % of those in the ipilimumab group .


Among previously untreated patients with metastatic melanoma , nivolumab alone or combined with ipilimumab resulted in significantly longer progression-free survival than ipilimumab alone .


In patients with PD-L1-negative tumors , the combination of PD-1 and CTLA-4 blockade was more effective than either agent alone .


( Funded by Bristol-Myers Squibb ; CheckMate 067 ClinicalTrials.gov number , NCT01844505 . )


Transcatheter aortic valve replacement ( TAVR ) is an option in certain high-risk surgical patients with severe aortic valve stenosis .


It is unknown whether TAVR can be safely introduced to lower-risk patients .


The NOTION ( Nordic Aortic Valve Intervention Trial ) randomized clinical trial compared TAVR with surgical aortic valve replacement ( SAVR ) in an all-comers patient cohort .


Patients 70 years old with severe aortic valve stenosis and no significant coronary artery disease were randomized 1:1 to TAVR using a self-expanding bioprosthesis versus SAVR .


The primary outcome was the composite rate of death from any cause , stroke , or myocardial infarction ( MI ) at 1 year .


A total of 280 patients were randomized at 3 Nordic centers .


Mean age was 79.1 years , and 81.8 % were considered low-risk patients .


In the intention-to-treat population , no significant difference in the primary endpoint was found ( 13.1 % vs. 16.3 % ; p = 0.43 for superiority ) .


The result did not change in the as-treated population .


No difference in the rate of cardiovascular death or prosthesis reintervention was found .


Compared with SAVR-treated patients , TAVR-treated patients had more conduction abnormalities requiring pacemaker implantation , larger improvement in effective orifice area , more total aortic valve regurgitation , and higher New York Heart Association functional class at 1 year .


SAVR-treated patients had more major or life-threatening bleeding , cardiogenic shock , acute kidney injury ( stage II or III ) , and new-onset or worsening atrial fibrillation at 30 days than did TAVR-treated patients .


In the NOTION trial , no significant difference between TAVR and SAVR was found for the composite rate of death from any cause , stroke , or MI after 1 year .


( Nordic Aortic Valve Intervention Trial [ NOTION ] ; NCT01057173 ) .


Current guidelines suggest a fasting time of 2 h for clear fluids , which is often exceeded in clinical practice , leading to discomfort , dehydration and stressful anaesthesia induction to patients , especially in the paediatric population .


Shorter fluid fasting might be a strategy to improve patient comfort but has not been investigated yet .


This prospective clinical trial compares gastric pH and residual volume after 1 vs 2 h of preoperative clear fluid fasting .


Children ( 1-16 yr , ASA I or II ) undergoing elective procedures in general anaesthesia requiring tracheal intubation were randomized into group A with 60 min or B with 120 min preoperative clear fluid fasting .


To determine gastric pH and residual volume , the gastric content was sampled in supine , left and right lateral patient position using an oro-gastric tube after intubation .


Data are median ( interquartile range ) for group A or B ( P < 0.05 ) .


In total , 131 children aged 1.01-16 .23 yr were included ; gastric pH was determined in 120 cases .


Patient characteristic data were similar between the two groups , except for gender ( 46/33 males in group A/B ; P = 0.02 ) .


Despite significantly shorter fasting times for clear fluids in group A compared with group B ( 76/136 min ; P < 0.001 ) , no significant difference was observed regarding gastric pH [ 1.43 ( 1.30-1 .56 ) / 1.44 ( 1.29-1 .68 ) , P = 0.66 ] or residual volume [ 0.43 ( 0.21-0 .84 ) / 0.46 ( 0.19-0 .78 ) ml kg ( -1 ) , P = 0.47 ] .


One hour clear fluid fasting does not alter gastric pH or residual volume significantly compared with 2 h fasting .


The study was approved by the local ethics committee ( KEK-ZH-Nr .


2011-0034 ) and registered with ClinicalTrials.gov ( NCT01516775 ) .


The objective of this study was to explore the significance of assessing irreversible airway obstruction ( IAO ) in asthma patients by high-resolution computed tomography ( HRCT ) , biological markers in induced sputum , and exhaled nitric oxide ( FENO ) .


The study was conducted in 34 patients with IAO , 46 patients with reversible airway obstruction ( RAO ) , 40 patients who did not have airway obstruction ( NAO ) , and 40 healthy subjects serving as controls .


These patients received a step therapy for at least 3 months based on the guidelines for the prevention and treatment of asthma .


After achieving complete or partial control of asthma , HRCT , lung function , FENO , and chemokine levels in induced sputum were measured .


The airway wall area ( WA ; % ) correlated with forced expiratory volume-1 ( FEV-1 ( L ) ; r = -0.67 , p < 0.0001 ) , and significant differences in bronchial wall thickening ( BWT ) of the LEVEL E generation airways were observed between the asthma and control groups ( p < 0.01 ) .


FENO levels correlated with FEV-1 ( % ) in the IAO group ( r = 0.49 , p = 0.01 ) .


The levels of matrix metalloproteases-9 ( MMP-9 ) and tissue inhibitor of matrix metalloproteinase-1 ( TIMP-1 ) in asthma patients with IAO , RAO , and NAO were significantly higher than those in the controls ( p < 0.05 ) .


The level of neutrophilia in the sputum from the IAO group was higher than that from the RAO , NAO and control groups .


Asthma patients with IAO have an increased BWT .


Airway measurements with HRCT scans appear to be valuable in the evaluation of airway remodeling in asthma patients with IAO .


To observe the difference in the therapeutic effects on knee osteoarthritis ( KOA ) among auricular electroacupuncture therapy plus isolated moxibustion with Lingxian herbal paste ( combined therapy ) , electroacupuncture ( EA ) and TDP irradiation .


Eighty-nine cases were randomized into three groups .


In the combined therapy group ( 30 cases ) , the auricular electroacupuncture therapy was adopted together with the isolated moxibustion with Lingxian herbal paste .


The auricular points were xi ( AH4 ) , pizhixia ( AT4 ) , shenmen ( TF4 ) , etc. .


The Lingxian herbal paste was applied at Yanglingquan ( GB 34 ) , Dubi ( ST 35 ) , Zusanli ( ST 36 ) , Neixiyan ( EX-LE 4 ) , Heding ( EX-LE 2 ) and Ashi points .


In EA group ( 29 cases ) , EA was applied at the acupoints that were same as those in the isolated moxibustion with Lingxian herbal paste .


In TDP group ( 30 cases ) , TDP irradiation was given at the affected knee .


The treatment was given once every day , 10 treatments made one session and there was 1 week at the interval among sessions .


Totally , 3 sessions of treatment were required .


KOA clinical symptom and physical sign score and the single item pain symptom score of Lequesne index were observed before treatment and 1 week after treatment in the patients of each group separately .


The efficacies were compared among the three groups .


One week after treatment , the total score of symptoms and physical signs of the patients in each group was reduced significantly as compared with that before treatment ( all P < 0.05 ) .


The improvements in the symptoms and physical signs in the combined therapy group were better than those in the other two groups ( 1.50 + / - 1.57 vs 2.52 + / - 1.82 , 2.63 + / - 1.97 , both P < 0.05 ) .


The improvement in pain in the combined therapy group was also better than that in the other two groups ( 2.37 + / - 0.81 vs 2.83 + / - 0.92 , P < 0.05 ; 2.37 + / - 0.81 vs 3.03 + / - 0.77 , P < 0.01 ) .


The curative rate in the combined therapy group was 40.0 % ( 12/30 ) , which was higher than 17.2 % ( 5/29 ) in EA group and 20.0 % ( 6/30 ) in TDP group separately ( both P < 0.01 ) .


The overall efficacy in the combined therapy group was superior to the other two groups ( P < 0.05 ) .


The auricular electroacupuncture therapy plus isolated moxibustion with Lingxian herbal paste is advantageous at the total score of the symptoms and physical signs and the overall efficacy in the patients of KOA as compared with EA at the local acupoints and local TDP irradiation .


The successful recruitment and retention of participants is integral to the translation of research findings .


We examined the recruitment and retention rates of racial/ethnic minority adolescents at a center involved in the National Institutes of Health Obesity Research for Behavioral Intervention Trials ( ORBIT ) initiative by the 3 recruitment strategies used : clinic , informatics , and community .


During the 9-month study , 186 family dyads , each composed of an obese African American adolescent and a caregiver , enrolled in a 6-month weight-loss intervention , a sequential multiple assignment randomized trial .


We compared recruitment and retention rates by recruitment strategy and examined whether recruitment strategy was related to dyad baseline characteristics .


Of the 186 enrolled families , 110 ( 59.1 % ) were recruited through clinics , 53 ( 28.5 % ) through informatics , and 23 ( 12.4 % ) through community .


Of those recruited through community , 40.4 % enrolled in the study , compared with 32.7 % through clinics and 8.2 % through informatics .


Active refusal rate was 3 % .


Of the 1,036 families identified for the study , 402 passively refused to participate : 290 ( 45.1 % ) identified through informatics , 17 ( 29.8 % ) through community , and 95 ( 28.3 % ) through clinics .


Recruitment strategy was not related to the age of the adolescent , adolescent comorbidities , body mass index of the adolescent or caregiver , income or education of the caregiver , or retention rates at 3 months , 7 months , or 9 months .


Study retention rate was 87.8 % .


Using multiple recruitment strategies is beneficial when working with racial/ethnic minority adolescents , and each strategy can yield good retention .


Research affiliated with health care systems would benefit from the continued specification , refinement , and dissemination of these strategies .


To determine whether any tumor biomarkers could account for the survival advantage observed in the LNH 03-2B trial among patients with diffuse large B-cell lymphoma ( DLBCL ) and low-intermediate risk according to the International Prognostic Index when treated with dose-intensive rituximab , doxorubicin , cyclophosphamide , vindesine , bleomycin , and prednisone ( R-ACVBP ) compared with standard rituximab , doxorubicin , cyclophosphamide , vincristine , and prednisone ( R-CHOP ) .


Using immunohistochemistry , expression of CD10 , BCL6 , MUM1 , MYC , and BCL2 and coexpression of MYC/BCL2 were examined .


The interaction effects between each biomarker and treatment arm on survival were studied in a restricted model and a full model incorporating clinical parameters .


Among the 379 patients analyzed in the trial , 229 tumors were evaluable for germinal center B-cell-like ( GCB ) / non-GCB subclassification according to the Hans algorithm .


Among all the biomarkers , only the interaction between the Hans algorithm and the treatment arm was significant for progression-free survival ( PFS ) and overall survival ( OS ) in univariable ( PFS , P = .04 ; OS , P = .01 ) and multivariable ( PFS , P = .03 ; OS , P = .01 ) analyses .


Non-GCB tumors predicted worse PFS ( hazard ratio [ HR ] , 3.21 ; 95 % CI , 1.29 to 8.00 ; P = .01 ) and OS ( HR , 6.09 ; 95 % CI , 1.37 to 27.03 ; P = .02 ) among patients treated with R-CHOP compared with patients who received R-ACVBP , whereas there were no significant survival differences between these regimens among patients with GCB tumors .


The survival benefit related to R-ACVBP over R-CHOP is at least partly linked to improved survival among patients with non-GCB DLBCL .


Therefore , the Hans algorithm could be considered a theragnostic biomarker for selecting young patients with DLBCL who can benefit from an intensified R-ACVBP immunochemotherapy regimen .


Glucose , the conventional osmotic agent in peritoneal dialysis ( PD ) solutions , may contribute to atherogenic dyslipoproteinemia and increased cardiovascular risk .


To determine whether a low-glucose PD regimen may improve the serum lipid and lipoprotein profile in patients with diabetes .


A prospective , open-label , parallel group , multinational , randomized , controlled trial with a 6-month follow-up , comprising 251 patients with diabetes receiving PD .


Patients were randomized to a low-glucose PD regimen ( dextrose-based PD solution plus icodextrin , a starch polymer , and amino acids ) or a conventional PD regimen ( dextrose PD solutions ) .


Serum lipid and apolipoprotein profiles were determined at baseline and 3 and 6 months .


Serum triglycerides , very low-density-lipoprotein cholesterol , and apolipoprotein B ( apoB ) decreased significantly in the intervention group at both 3 and 6 months compared with baseline ( serum triglycerides : median change at 3 months -0.5 mmol/L , P < .001 , at 6 months -0.3 mmol/L , P < .001 ; very low-density-lipoprotein cholesterol : -0.3 mg/dL , P < .001 ; -0.3 mg/dL , P < .001 ; and apoB : -8.5 mg/dL , P < .001 ; -3.6 mg/dL , P = .043 , respectively ) and also compared with the control group .


In contrast , apoB levels increased significantly in the control group at 3 and 6 months compared with baseline ( 5.3 mg/dL , P = .041 ; 5.2 mg/dL , P = .007 , respectively ) .


Percentage of patients on lipid-lowering medications at baseline and intensity of therapy was equivalent in each group .


The apoB decrease was not affected by lipid-lowering medications in the intervention group .


A low glucose-PD regimen significantly improved the atherogenic lipoprotein phenotype compared with PD patients treated with a conventional glucose regimen .


Epidemiological studies have shown that low levels of dehydroepiandrosterone might increase the risk of developing metabolic syndrome .


The aim of this study was to evaluate whether dehydroepiandrosterone supplementation in schizophrenic patients treated with olanzapine would influence the anthropometric and biochemical parameters of metabolic syndrome .


Male schizophrenic patients ( no = 55 ) participated in a twelve-week , randomized , double blind , placebo controlled study .


They received 100 mg dehydroepiandrosterone ( DHEA ) or placebo as an augmentation of olanzapine treatment ( an average dosage 15 mg/day ) .


Main outcomes of the study were changes in lipid profile , fasting glucose levels , body mass index and waist circumference values .


Forty five patients completed the study .


There were no major changes in the overall cholesterol value , HDL cholesterol , LDL cholesterol or triglycerides in either group .


The results of the repeated measures analysis of the system : fasting glucose level 2x , ( at the beginning and end of the study ) , 2x ( the study group and the control group ) , showed a significant interaction ( F = 5.7 , df = 1.000 p = 0.021 ) .


The blood glucose level was decreased in the DHEA group .


Furthermore , increases in waist circumference ( delta = -1.11 , t = -2.87 ; df = 20 ; p = 0.01 ) and BMI value ( delta = -0.48 , t = -2.38 ; df = 19 ; p = 0.028 ) were observed in the placebo group .


Dehydroepiandrosterone supplementation results in stabilization of BMI , waist circumference and fasting glycaemia values in schizophrenic patients treated with olanzapine .


To confirm the insulin-like effect of dehydroepiandrosterone , long-term research concentrating on the evaluation of glucose metabolism has to be performed .


To assess the relief of migraine pain , especially in the acute phase , by comparing active treatment , ie , kinetic oscillation stimulation ( KOS ) in the nasal cavity , with placebo .


Exploratory trials testing the efficacy of KOS on migraine patients indicated that this treatment could be a fast-acting remedy for acute migraine pain .


Thirty-six patients were randomized 1:1 using a placebo module to active or placebo treatment in this double-blinded parallel design study .


Treatment was administered with a minimally invasive inflatable tip oscillating catheter .


Symptom scores ( 0-10 visual analog scale ) were obtained before treatment , every 5 minutes during treatment , at 15 minutes , 2 , and 24 hours post-treatment , as well as daily ( 0-3 migraine pain scale ) from 30 days pretreatment until Day 60 post .


Thirty-five patients were evaluated ( active n = 18 , placebo n = 17 ) .


The primary end-point was the change in average pain score from before treatment to 15 minutes after treatment .


Patients who received active treatment reported reduced pain , eg , average visual analog scale pain scores fell from 5.5 before treatment to 1.2 15 minutes after , while the corresponding scores for recipients of placebo fell from 4.9 to 3.9 .


The changes in pain scores differed between the 2 treatments by 3.3 points ( 95 % confidence interval : 2.3 , 4.4 ) , P < .001 .


Already 5 minutes into the treatment , the difference ( 1.9 points ) was significant ( P = .007 ) .


The difference was likewise significant at 2 hours post-treatment ( 3.7 points , P < .001 ) .


One patient experienced an adverse event ( a vasovagal reaction with full spontaneous recovery ) during placebo treatment .


KOS is an effective and safe treatment for acute migraine pain .


Melasma is a common disorder of facial hyperpigmentation that is often resistant to treatment .


To evaluate the efficacy of trichloroacetic acid ( TCA ) peeling in comparison with double frequency Q-switched neodymium-doped : yttrium aluminum garnet ( QS-Nd : YAG ) laser in the treatment of melasma .


Sixty-five adult Egyptian female patients with melasma were enrolled in this study .


Wood light was used for determination of the histological type of melasma .


The patients were divided into 4 groups according to treatment modalities : peeling with different concentrations of TCA and double frequency QS-Nd : YAG laser .


Trichloroacetic acid peeling was performed every 2 weeks up to 8 sessions , whereas laser treatment was performed every month up to 6 sessions .


Melasma area and severity index ( MASI ) score was used before and after treatment for evaluation .


Improvement percentage of MASI score was significantly higher among patients treated with TCA 25 % ( p < .001 ) .


Epidermal type of melasma was significantly improved compared with the dermal type ( p = .0029 ) .


Q-switched neodymium-doped : yttrium aluminum garnet laser showed the highest incidence of postinflammatory hyperpigmentation ( 53.3 % ) .


Trichloroacetic acid peeling is effective in the treatment of melasma , TCA 25 % was the most effective concentration .


Q-switched neodymium-doped : yttrium aluminum garnet laser is not recommended in the treatment of melasma because it was associated with the highest incidence of complications .


We investigated whether 18 months of androgen suppression plus radiotherapy , with or without 18 months of zoledronic acid , is more effective than 6 months of neoadjuvant androgen suppression plus radiotherapy with or without zoledronic acid .


We did an open-label , randomised , 22 factorial trial in men with locally advanced prostate cancer ( either T2a N0 M0 prostatic adenocarcinomas with prostate-specific antigen [ PSA ] 10 g/L and a Gleason score of 7 , or T2b-4 N0 M0 tumours regardless of PSA and Gleason score ) .


We randomly allocated patients by computer-generated minimisation -- stratified by centre , baseline PSA , tumour stage , Gleason score , and use of a brachytherapy boost -- to one of four groups in a 1:1:1:1 ratio .


Patients in the control group were treated with neoadjuvant androgen suppression with leuprorelin ( 225 mg every 3 months , intramuscularly ) for 6 months ( short-term ) and radiotherapy alone ( designated STAS ) ; this procedure was either followed by another 12 months of androgen suppression with leuprorelin ( intermediate-term ; ITAS ) or accompanied by 18 months of zoledronic acid ( 4 mg every 3 months for 18 months , intravenously ; STAS plus zoledronic acid ) or by both ( ITAS plus zoledronic acid ) .


The primary endpoint was prostate cancer-specific mortality .


This analysis represents the first , preplanned assessment of oncological endpoints , 5 years after treatment .


Analysis was by intention-to-treat .


This trial is registered with ClinicalTrials.gov , number NCT00193856 .


Between Oct 20 , 2003 , and Aug 15 , 2007 , 1071 men were randomly assigned to STAS ( n = 268 ) , STAS plus zoledronic acid ( n = 268 ) , ITAS ( n = 268 ) , and ITAS plus zoledronic acid ( n = 267 ) .


Median follow-up was 74 years ( IQR 65-84 ) .


Cumulative incidences of prostate cancer-specific mortality were 41 % ( 95 % CI 22-70 ) in the STAS group , 78 % ( 49-115 ) in the STAS plus zoledronic acid group , 74 % ( 46-110 ) in the ITAS group , and 43 % ( 23-73 ) in the ITAS plus zoledronic acid group .


Cumulative incidence of all-cause mortality was 170 % ( 130-221 ) , 189 % ( 146-242 ) , 194 % ( 150-247 ) , and 139 % ( 103-188 ) , respectively .


Neither prostate cancer-specific mortality nor all-cause mortality differed between control and experimental groups .


Cumulative incidence of PSA progression was 342 % ( 286-399 ) in the STAS group , 396 % ( 336-455 ) in the STAS plus zoledronic acid group , 292 % ( 238-348 ) in the ITAS group , and 260 % ( 208-314 ) in the ITAS plus zoledronic acid group .


Compared with STAS , no difference was noted in PSA progression with ITAS or STAS plus zoledronic acid ; however , ITAS plus zoledronic acid reduced PSA progression ( sub-hazard ratio [ SHR ] 071 , 95 % CI 053-095 ; p = 0021 ) .


Cumulative incidence of local progression was 41 % ( 22-70 ) in the STAS group , 61 % ( 37-95 ) in the STAS plus zoledronic acid group , 15 % ( 05-37 ) in the ITAS group , and 34 % ( 17-61 ) in the ITAS plus zoledronic acid group ; no differences were noted between groups .


Cumulative incidences of bone progression were 75 % ( 48-111 ) , 146 % ( 106-192 ) , 84 % ( 55-122 ) , and 76 % ( 48-112 ) , respectively .


Compared with STAS , STAS plus zoledronic acid increased the risk of bone progression ( SHR 190 , 95 % CI 114-317 ; p = 0012 ) , but no differences were noted with the other two groups .


Cumulative incidence of distant progression was 147 % ( 107-192 ) in the STAS group , 173 % ( 130-221 ) in the STAS plus zoledronic acid group , 142 % ( 103-187 ) in the ITAS group , and 111 % ( 76-152 ) in the ITAS plus zoledronic acid group ; no differences were recorded between groups .


Cumulative incidence of secondary therapeutic intervention was 256 % ( 205-309 ) , 289 % ( 235-345 ) , 207 % ( 161-259 ) , and 153 % ( 113-200 ) , respectively .


Compared with STAS , ITAS plus zoledronic acid reduced the need for secondary therapeutic intervention ( SHR 067 , 95 % CI 048-095 ; p = 0024 ) ; no differences were noted with the other two groups .


An interaction between trial factors was recorded for Gleason score ; therefore , we did pairwise comparisons between all groups .


Post-hoc analyses suggested that the reductions in PSA progression and decreased need for secondary therapeutic intervention with ITAS plus zoledronic acid were restricted to tumours with a Gleason score of 8-10 , and that ITAS was better than STAS in tumours with a Gleason score of 7 or lower .


Long-term morbidity and quality-of-life scores were not affected adversely by 18 months of androgen suppression or zoledronic acid .


Compared with STAS , ITAS plus zoledronic acid was more effective for treatment of prostate cancers with a Gleason score of 8-10 , and ITAS alone was effective for tumours with a Gleason score of 7 or lower .


Nevertheless , these findings are based on secondary endpoint data and post-hoc analyses and must be regarded cautiously .


Long - term follow-up is necessary , as is external validation of the interaction between zoledronic acid and Gleason score .


STAS plus zoledronic acid can be ruled out as a potential therapeutic option .


National Health and Medical Research Council of Australia , Novartis Pharmaceuticals Australia , Abbott Pharmaceuticals Australia , New Zealand Health Research Council , New Zealand Cancer Society , University of Newcastle ( Australia ) , Calvary Health Care ( Calvary Mater Newcastle Radiation Oncology Fund ) , Hunter Medical Research Institute , Maitland Cancer Appeal , Cancer Standards Institute New Zealand .


Gender dysphoria is characterized by a strong discomfort with the gender assigned at birth and the urge to live as a member of the opposite gender .


The acquisition of phenotypic features of the desired gender requires the use of cross-sex hormones .


Female-to-male ( FtM ) transsexual persons are treated with testosterone to induce virilization .


The aim of the study was to assess the effects of three different testosterone formulations on body weight and composition and metabolic and bone parameters .


Forty-five FtM transsexuals were randomly assigned to receive testoviron depot ( i.m. : 100mg/10 days ; n = 15 ) , testosterone gel ( 50mg/die ; n = 15 ) , and testosterone undecanoate ( i.m. : 1,000 mg every 6 weeks for the first 6 weeks and then every 12 weeks , n = 15 ) .


FtM individuals were studied before , at week 30 , and at week 54 of testosterone treatment .


Anthropometric , metabolic , bone , hematological , and biochemical parameters were evaluated at baseline and after 12 months of treatment .


Lean body mass significantly increased and fat mass decreased in all groups .


No modifications were reported in fasting insulin and insulin sensitivity index .


High-density plasma lipoprotein levels declined significantly and low-density lipoprotein concentrations increased significantly in the three groups .


The activated partial thromboplastin time and factor I did not change while prothrombin time significantly increased in all groups .


At week 54 , all subjects were amenorrheic and time to amenorrhea did not differ between the three groups .


Current general life satisfaction was increased in all subjects after 1 year of treatment .


One-year testosterone administration in FtM transsexuals appears to be very safe with no differences among the testosterone formulations used .


Our study is preliminary , and the detection of subtle or long-term differences in the effects of the three formulations may require further larger and longer term studies in this and other populations .


Migraine shows gender-specific incidence and has a higher prevalence in females .


Gender plays an important role in the prevalence of migraine , but few studies have investigated the effect of gender on the cognitive functions of migraine patients .


This study investigated gender differences in the cognitive function of migraine patients without aura .


We recruited 29 migraine patients ( 15 females ; mean age 25.4 y ) during the interictal period and 28 healthy age-matched participants ( 14 females ; mean age 24.8 y ) .


We used an auditory oddball paradigm to analyze target processing using event-related potentials .


We investigated the N2 and P3 components .


The P3 amplitude was decreased in patients compared with the control , and this reduction was not modulated by gender .


These results of the P3 provided a new evidence for the dysfunction of cognitive function in migraine patients .


The N2 amplitude was larger for male than female migraine patients , and this gender effect was not found in the control group .


And those of N2 may explain that male patients have the super-sensitivity of cerebral function relevant to the early target-selection and response preparation .


Our findings emphasize the importance of considering gender when researching the cognitive function of migraine patients .


Data about the influence of the type of sedation on yield , complications , and tolerance of endobronchial ultrasound-guided transbronchial needle aspiration ( EBUS-TBNA ) are based mostly on retrospective studies and are largely inconsistent .


To determine whether the type of sedation influences the diagnostic yield of EBUS-TBNA , its complication rates , and patient tolerance .


Patients referred for EBUS-TBNA were randomized ( 1:1 ) to undergo this procedure under general anesthesia ( GA ) or moderate sedation ( MS ) .


Pathologists were blinded to group allocation .


The main outcome was `` diagnostic yield , '' defined as the percentage of patients for whom EBUS-TBNA rendered a specific diagnosis .


One hundred and forty-nine patients underwent EBUS-TBNA , 75 under GA and 74 under MS. Demographic and baseline clinical characteristics were well balanced .


Two hundred and thirty-six lymph nodes ( LNs ) and six masses were sampled in the GA group ( average , 3.2 1.9 sites/patient ) , and 200 LNs and six masses in the MS group ( average , 2.8 1.5 sites/patient ) ( P = 0.199 ) .


The diagnostic yield was 70.7 % ( 53 of 75 ) and 68.9 % ( 51 of 74 ) for the GA group and MS group , respectively ( P = 0.816 ) .


The sensitivity was 98.2 % in the GA group ( confidence interval , 97-100 % ) and 98.1 % in the MS group ( confidence interval , 97-100 % ) ( P = 0.979 ) .


EBUS was completed in all patients in the GA group , and in 69 patients ( 93.3 % ) in the MS group ( P = 0.028 ) .


There were no major complications or escalation of care in either group .


Minor complications were more common in the MS group ( 29.6 vs. 5.3 % ) ( P < 0.001 ) .


Most patients stated they `` definitely would '' undergo this procedure again in both groups ( P = 0.355 ) .


EBUS-TBNA performed under MS results in comparable diagnostic yield , rate of major complications , and patient tolerance as under GA. .


Future prospective multicenter studies are required to corroborate our findings .


Clinical trial registered with www.clinicaltrials.gov ( NCT 01430962 ) .


To describe the interindividual variability in physical function responses to supervised resistance and aerobic exercise training interventions in older adults .


Data analysis of two randomized , controlled exercise trials .


Community-based research centers .


Overweight and obese ( body mass index ( BMI ) 27.0 kg/m2 ) sedentary men and women aged 65 to 79 ( N = 95 ) .


Five months of 4 d/wk of aerobic training ( AT , n = 40 ) or 3 d/wk of resistance training ( RT , n = 55 ) .


Physical function assessments : global measure of lower extremity function ( Short Physical Performance Battery ( SPPB ) ) , 400-m walk , peak aerobic capacity ( VO2 peak ) , and knee extensor strength .


On average , both exercise interventions significantly improved physical function .


For AT , there was a 7.9 % increase in VO2 peak ; individual absolute increases varied from 0.4 to 4.3 mL/kg per minute , and four participants ( 13 % ) showed no change or a decrease in VO2 peak .


For RT , knee extensor strength improved an average of 8.1 % ; individual increases varied from 1.2 to 63.7 Nm , and 16 participants ( 30 % ) showed no change or a decrease in strength .


Usual gait speed , 400-m walk time , chair rise time , and SPPB improved for the majority of AT participants and usual gait speed , chair rise time , and SPPB improved for the majority of RT participants , but there was wide variation in the magnitude of improvement .


Only change in 400-m walk time with RT was related to exercise adherence ( correlation coefficient = -0.31 , P = .004 ) .


Despite sufficient levels of adherence to both exercise interventions , some participants did not improve function , and the magnitude of improvement varied widely .


Additional research is needed to identify factors that optimize responsiveness to exercise to maximize its functional benefits in older adults .


People with multi-drug resistant tuberculosis ( MDR-TB ) in low-income countries face many problems during treatment , and cure rates are low .


The purpose of the study was ( a ) to identify and document the problems experienced by people receiving care for MDR-TB , and how they cope when support is not provided , to inform development of strategies ; ( b ) to estimate the effectiveness of two resultant strategies , counselling alone , and joint counselling and financial support , of increasing DOTS-plus treatment success under routine programme conditions .


A mixed-method study comprising a formative qualitative study , pilot intervention study and explanatory qualitative study to better understand barriers to completion of treatment for MDR-TB .


Participants were all people starting MDR-TB treatment in seven DOTS-plus centres in the Kathmandu Valley , Nepal during January to December 2008 .


The primary outcome measure was cure , as internationally defined .


MDR-TB treatment caused extreme social , financial and employment hardship .


Most patients had to move house and leave their job , and reported major stigmatisation .


They were concerned about the long-term effects of their disease , and feared infecting others .


In the resultant pilot intervention study , the two strategies appeared to improve treatment outcomes : cure rates for those receiving counselling , combined support and no support were 85 % , 76 % and 67 % respectively .


Compared with no support , the ( adjusted ) risk ratios of cure for those receiving counselling and receiving combined support were 1.2 ( 95 % CI 1.0 to 1.6 ) and 1.2 ( 95 % CI 0.9 to 1.6 ) respectively .


The explanatory study demonstrated that patients valued both forms of support .


MDR-TB patients are extremely vulnerable to stigma and extreme financial hardship .


Provision of counselling and financial support may not only reduce their vulnerability , but also increase cure rates .


National Tuberculosis Programmes should consider incorporating financial support and counselling into MDR-TB care : costs are low , and benefits high , especially since costs to society of incomplete treatment and potential for incurable TB are extremely high .


Acute kidney injury often goes unrecognised in its early stages when effective treatment options might be available .


We aimed to determine whether an automated electronic alert for acute kidney injury would reduce the severity of such injury and improve clinical outcomes in patients in hospital .


In this investigator-masked , parallel-group , randomised controlled trial , patients were recruited from the hospital of the University of Pennsylvania in Philadelphia , PA , USA .


Eligible participants were adults aged 18 years or older who were in hospital with stage 1 or greater acute kidney injury as defined by Kidney Disease Improving Global Outcomes creatinine-based criteria .


Exclusion criteria were initial hospital creatinine 40 mg/dL ( to convert to mol/L , multiply by 884 ) or greater , fewer than two creatinine values measured , inability to determine the covering provider , admission to hospice or the observation unit , previous randomisation , or end-stage renal disease .


Patients were randomly assigned ( 1:1 ) via a computer-generated sequence to receive an acute kidney injury alert ( a text-based alert sent to the covering provider and unit pharmacist indicating new acute kidney injury ) or usual care , stratified by medical versus surgical admission and intensive care unit versus non-intensive care unit location in blocks of 4-8 participants .


The primary outcome was a composite of relative maximum change in creatinine , dialysis , and death at 7 days after randomisation .


All analyses were by intention to treat .


This study is registered with ClinicalTrials.gov , number NCT01862419 .


Between Sept 17 , 2013 , and April 14 , 2014 , 23,664 patients were screened .


1201 eligible participants were assigned to the acute kidney injury alert group and 1192 were assigned to the usual care group .


Composite relative maximum change in creatinine , dialysis , and death at 7 days did not differ between the alert group and the usual care group ( p = 088 ) , or within any of the four randomisation strata ( all p > 005 ) .


At 7 days after randomisation , median maximum relative change in creatinine concentrations was 00 % ( IQR 00-184 ) in the alert group and 06 % ( 00-175 ) in the usual care group ( p = 081 ) ; 87 ( 72 % ) patients in the alert group and 70 ( 59 % ) patients in usual care group had received dialysis ( odds ratio 125 [ 95 % CI 090-174 ] ; p = 018 ) ; and 71 ( 59 % ) patients in the alert group and 61 ( 51 % ) patients in the usual care group had died ( 116 [ 081-168 ] ; p = 040 ) .


An electronic alert system for acute kidney injury did not improve clinical outcomes among patients in hospital .


Penn Center for Healthcare Improvement and Patient Safety .


To compare planning and patient rehabilitation using a 3D dental planning software and dedicated surgical guides with conventional rehabilitation of partially or fully edentulous patients using flapless or mini-flap procedures and immediate loading .


Fifty-one fully or partially edentulous patients requiring at least 2 implants to be restored with a single prosthesis , having at least 7 mm of bone height and 4 mm in bone width , had their implant rehabilitation planned on three-dimensional ( 3D ) cone beam computed tomography ( CBCT ) scans using a dedicated software .


Afterwards they were randomised according to a parallel group study design into two arms : computer-guided implant placement aided with templates ( computer-guided group ) versus conventional implant placement without templates ( conventional group ) in three different centres .


Implants were to be placed flapless and loaded immediately ; if inserted with a torque over 35 Ncm with reinforced provisional prostheses , then replaced , after 4 months , by definitive prostheses .


Outcome measures , assessed by masked assessors were : prosthesis and implant failures , complications , peri-implant bone level changes , number of treatment sessions , duration of treatment , post-surgical pain and swelling , consumption of pain killers , treatment time , time required to solve complications , additional treatment cost , patient satisfaction .


Patients were followed up to 1 year after loading .


Twenty-six patients were randomised to the conventional treatment and 25 to computerguided rehabilitation .


No patient dropped out .


One provisional prosthesis failed , since one of the two supporting implants failed 11 days after implantation in the conventional group ( P = 1.0 ) .


Four patients of the conventionally loaded groups experienced one complication each , versus five patients ( 6 complications ) in the computer-guided group ( P = 0.726 ) .


There were no statistically significant differences between the two groups for any of the tested outcomes with the exception of more postoperative surgical pain ( P = 0.002 ) and swelling ( P = 0.024 ) at conventionally treated patients .


When treatment planning was made on 3D CBTC scan using a dedicated software , no statistically significant differences were observed between computer-guided and a free-hand rehabilitations , with the exception of more postoperative pain and swelling at sites treated freehand because more frequently flaps were elevated .


This study is aimed to identify the expression of Notch family proteins in placentas from patients with early-onset severe preeclampsia .


The expression of Notch family proteins in placentas was investigated by immunohistochemistry , Western blotting , and real-time reverse transcription-polymerase chain reaction ( RT-PCR ) .


The profile of distribution of all Notch family proteins in placentas from patients with early-onset severe preeclampsia is similar to that in normal placentas .


All Notch family proteins are expressed in placental trophoblasts .


Moreover , Notch1 and Jagged1 ( Jag1 ) are detected in placental endothelial cells .


Real-time RT-PCR showed that messenger RNA levels of Notch2 and Delta-like4 ( Dll4 ) in placentas from patients with early-onset severe preeclampsia are lower than that of normal placentas .


Western blotting showed a significant increase in Notch3 expression and a significant decrease in Notch2 expression in placentas from patients with early-onset severe preeclampsia relative to those in normal placentas .


The results suggest that Notch2 and Notch3 may play some roles in the pathogenesis of preeclampsia .


To compare the difference in the efficacy between acupuncture and oral administration of trazodone and the expressions of neurotransmitters in patients of insomnia differentiated as liver stagnation transforming into fire .


Seventy patients of insomnia differentiated as liver stagnation transforming into fire were randomized into an observation group and a control group , 35 cases in each one .


In the observation group , acupuncture therapy was adopted at Shenmen ( HT 7 ) , Baihui ( GV 20 ) , Yintang ( GV 29 ) , Hegu ( LI 4 ) , Taichong ( LR 3 ) , etc. .


The needles were retained for 20 min each time .


The treatment was given once a day , the treatment of 2 weeks made one session .


In the control group , trazodone , 100 mg , oral administration , once a day , the treatment of 2 weeks made one session .


Two sessions were required in the two groups .


The scores in Pittsburgh sleep quality index ( PSQI ) and Asberg rating scale for side effects ( SERS ) , the levels of neurotransmitters such as 5-hydroxy tryptamine ( 5-HT ) and norepinephrine ( NE ) and the expressions of protein kinase C ( PKC ) and brain-derived neurotrophic factor ( BDNF ) in peripheral blood were observed before and after treatment in the two groups .


PSQI score and SERS score after treatment were all decreased compared with those in both groups before treatment ( both P < 0.05 ) .


After treatment , PSQI score and SERS score in the observation group were lower apparently than those in the control group ( both P < 0.05 ) .


After treatment NE content and PKC level were decreased ; 5-HT content and BDNF mRNA were increased compared with those in both groups before treatment ( all P < 0.05 ) .


NE content and PKC level in the observation group were lower apparently than those in the control group ( both P < 0.05 ) .


The serum 5-HT content and BDNF mRNA expression in the observation group were higher than those in the control group separately ( both P < 0.05 ) .


Acupuncture therapy improves the sleeping quality of patients of insomnia differentiated as liver stagnation transforming into fire , and reduces serum NE level and increases 5-HT content and BDNF expression , which achieves the better efficacy as compared with the oral administration of trazodone .


It is one of the effective approaches to the treatment of insomnia differentiated as liver stagnation transforming into fire .


With the increase in the aging population , there is a pressing need to provide effective treatment options for individuals with Alzheimer 's disease ( AD ) .


Memantine is an N-methyl-D-aspartate receptor antagonist used to treat AD in > 80 countries worldwide , and studies in the USA and Europe have shown it to be effective in improving language deficits ; however , there are currently no data on language improvements in Japanese patients treated with memantine .


To clarify the efficacy and safety of memantine in Japanese outpatients with moderate to severe AD , using a pooled analysis of two multicenter randomized placebo-controlled trials , a phase 2 dose-finding study and a phase 3 study .


The final analysis comprised 633 patients ( 318 receiving memantine and 315 placebo ) .


Memantine produced better outcomes in terms of Severe Impairment Battery-Japanese version , Clinician 's Interview-Based Impression of Change plus-Japanese version , Behavioral Pathology in AD Rating Scale , and language scores , versus placebo .


The overall incidence of adverse events and adverse reactions was similar between groups .


In this pooled analysis of Japanese patients , memantine achieved better outcomes than placebo in terms of cognition , including attention , praxis , visuospatial ability and language , and behavioral and psychological symptoms , including activity disturbances and aggressiveness .


To improve effectiveness of future screen behaviour interventions , one needs to know whether an intervention works via the proposed mediating mechanisms and whether the intervention is equally effective among subgroups .


Parental regulation is identified as a consistent correlate of screen behaviours , but prospective evidence as well as the mediation role of parental regulation is largely lacking .


This study investigated post-intervention main effects on screen behaviours in the HEIA-intervention -- a Norwegian school-based multiple-behaviour study , as well as mediation effects of parental regulation by adolescents ' and parents ' report .


In addition , moderating effects of gender and weight status on the intervention and mediating effects were explored .


Participating schools were randomized to control ( n = 25 ) or intervention ( n = 12 ) condition .


Adolescents ( n = 908 Control ; 510 Intervention ) self-reported their weekday and weekend TV-viewing and computer/game-use .


Change in adolescents ' behaviours was targeted through school and parents .


Adolescents , mothers ( n = 591 Control ; 244 Interventions ) and fathers ( n = 469 Control ; 199 Intervention ) reported parental regulation of the screen behaviours post-intervention ( at 20 month ) .


The product-of-coefficient test using linear regression analysis was conducted to examine main and mediating effects .


There was no intervention effect on the screen behaviours in the total sample .


Gender moderated effect on weekend computer/game-use , while weight status moderated the effect on weekday TV-viewing and computer/game-use .


Stratified analyses showed a small favourable intervention effect on weekday TV-viewing among the normal weight .


Parental regulation did not mediate change in the screen behaviours .


However , stronger parental regulation was associated with less TV-viewing and computer/game-use with effects being conditional on adolescents ' versus parental reports .


Parental regulation of the screen behaviours , primarily by the parental report , was associated with change in the respective behaviours .


Multiple behaviour intervention may not affect all equally well , and the effect may differ by weight status and gender .


In future interventions parents should be encouraged to regulate their adolescents ' TV-viewing and computer/game-use on both weekdays and weekends as parental regulation was identified as a determinant of these screen behaviours .


However , future intervention studies may need to search for more effective intervention strategies targeting parental regulation .


Current Controlled Trials ISRCTN98552879 .


The paper describes recruitment results and characteristics of the UP-TECH clinical trial sample , including level of care services use , informal caregiver burden and its determinants .


UP-TECH is designed to test innovative care solutions for community-dwelling patients with moderate stage Alzheimer 's disease and their caregivers in Italy .


Four hundred and fifty patient-caregiver dyads were randomized into three arms receiving different combinations of services , composed of case management interventions , nurse visits , assistive technology and educational brochures .


The research nurses administered a questionnaire comprising an in-depth socio-demographic assessment and several clinical scales , such as Novak 's Caregiver Burden Inventory .


Analyses of baseline data were conducted using uni - and bi-variate statistics .


Linear regressions were computed to identify de-confounded correlates of caregiver burden .


Four hundred and thirty-eight patient-caregiver dyads were recruited and randomized .


In our sample , patients are predominantly women ( 71.5 % ) , with an average age of 81.5 years and a mean Mini-Mental State Examination score of 16.2 .


Caregivers are mostly women ( 66.2 % ) and offspring ( 55.7 % ) , with a mean caregiver burden score of 27.6 .


They provide more than 50 hours of care per week , while receiving an almost negligible support from public services .


Factors associated with caregiver burden are female gender , kinship and the patient 's behavioral disturbances .


The most important factor associated with lower burden is the employment of a live-in care worker .


The paper provides a comprehensive description of moderate stage Alzheimer 's disease patients and their caregivers , suggesting useful markers of caregiver burden .


The well-balanced randomization assures the reliability of the study data-set for prospective evaluation of care strategies .


Right hemisphere stroke patients frequently experience spatial neglect , a severe lack of awareness for contralesional hemispace .


Although neglect counts among the strongest predictors for poor functional outcome after stroke , there is no established therapy , particularly not for the acute stage .


In a randomized controlled trial , we compared the combined treatment of hemifield eye patching and repetitive optokinetic stimulation in acute stroke patients with neglect to the spontaneous course .


Outcome measures were a neuropsychological test battery for neglect as well as scales of functional independence and clinical impairment .


Outcomes were assessed at baseline ( day 1 ) , post treatment ( day 8 ) , and at 1-month follow-up ( day 30 ) .


Final analysis included 21 acute right hemisphere stroke patients with neglect ( 23 enrolled , 2 lost to follow-up ) allocated either to the treatment ( 1 week hemifield eye patching and daily sessions of optokinetic stimulation , n = 11 ) or the control group ( no neglect-specific treatment , n = 10 ) .


At baseline , both groups did not differ in neuropsychological test performance , clinical impairment , or functional disability .


At the post treatment session , both groups had improved in all these measures , and results were stable or further improved at follow-up .


However , there was no significant difference in this change between the treatment and the control group .


An early intervention of combined hemifield eye patching and optokinetic stimulation in acute stroke patients with spatial neglect has no additive effect to the spontaneous remitting course of the disorder .


http://www.clinicaltrials.gov .


Unique identifier : NCT01617343 .


Hereditary hemorrhagic telangiectasia ( HHT ) is a dominantly inherited genetic vascular disorder in which epistaxis is the most frequent manifestation , responsible for high morbidity .


Management of this symptom has no standard , and local treatments are often aggressive .


Their efficacy is variable and has not been proven .


Anti-angiogenic drugs , such as bevacizumab , are a new treatment strategy .


Its systemic administration in patients with HHT improves liver damage-related symptoms and epistaxis .


To limit the systemic adverse effects of bevacizumab and to ease administration , a local administration seems suitable .


To evaluate the tolerance of increasing doses of bevacizumab administered as a nasal spray in patients with HHT-related epistaxis .


Secondary objectives were to study the bioavailability and efficacy of bevacizumab against epistaxis when given as a nasal spray .


Phase 1 , randomized , double-blind , placebo-controlled , monocentric study performed sequentially ( dose escalation ) on 5 groups of 8 patients .


Each group was made up of 6 verum and 2 placebos .


Five increasing doses of bevacizumab nasal spray ( 25 mg/mL ) were evaluated : 12.5 , 25 , 50 , 75 and 100 mg .


A total of 40 patients were included between October 2011 and October 2012 .


Bevacizumab nasal spray was well tolerated in all patients and the drug was not detected in their serum .


No dose limiting toxicity was observed .


No efficacy was observed at any dose in this study .


Based on these results , bevacizumab nasal spray is a safe treatment of epistaxis in HHT .


However , a randomized Phase 2 study is needed to determine its efficacy .


ClinicalTrials.gov Identifier #NCT 01507480 .


Bipolar depression is one of the most serious psychiatric conditions .


In addition , sleep disturbance in bipolar disorder is common , and therapeutic agents restoring sleep disturbances in bipolar disorder patients will be clinically beneficial .


In the current study , we compared the effect of quetiapine XR with lithium on depressive symptoms and sleep in bipolar depression patients during 8 weeks of trial .


An open-label , randomized comparison of sleep-activity and depressive symptoms between 8-week quetiapine XR monotherapy and lithium monotherapy for bipolar depression was conducted .


Each assessment consisted of HDRS-17 , Clinical Global Impression-severity ( CGI-S ) , and self-reported Pittsburgh Sleep Quality Index ( PSQI ) .


Actigraphy-measured sleep parameters were assessed .


A total of 42 patients ( 35.710.9 years ; gender : male 15 , female 27 ) with bipolar depression were screened out .


Out of 42 patients , six patients were excluded before randomization .


After randomization , seven patients were withdrawn .


Twenty-nine patients with more than two visits after randomization ( lithium group : 17 , quetiapine XR group : 12 , mean age : 36.110.4 , gender : male 13 , female 16 ) were included in the final analysis .


In both groups , Hamilton Depression Rating Scale ( HDRS ) scores were significantly decreased at weeks 1 , 2 , 4 , 6 , and 8 compared with baseline .


Remission rate ( HDRS7 ) in the quetiapine XR was significantly higher than that of the lithium group .


In the quetiapine XR group , PSQI scores at weeks 1 , 2 , 4 , 6 , and 8 was significantly decreased compared with baseline .


Sleep efficiency at weeks 6 and 8 was significantly increased .


WASO at week 8 was significantly decreased .


First , the present study was conducted with the relatively small number of study subjects .


Second , bias could have affected the study results due to its open-label design .


Third , study subjects were made up of high proportion of bipolar II disorder patients .


Quetiapine XR monotherapy was more effective in treating bipolar depression than lithium .


In particular , quetiapine XR treatment improved both subjective and objective sleep quality in patients with bipolar depression .


However , relationship between favorable sleep quality and depressive symptom improvement were limited .


To analyse the clinical significance and related factors of thirst and xerostomia and to find methods to alleviate thirst and xerostomia in maintenance hemodialysis ( MHD ) patients .


Forty-two MHD patients were included for observational study and eleven patients were enrolled for crossover trial .


Thirst was assessed by 100-mm visual analog scales ( VAS ) and dialysis thirst inventory ( DTI ) .


Meanwhile , xerostomia was assessed by VAS and xerostomia inventory ( XI ) .


Depression , kidney disease quality of life ( KDQOL ) , salivary flow rates and inter dialytic weight gain ( IDWG ) were measured .


Data were analyzed by ANOVA and correlation coefficient was used to assess the correlations between continuous variables .


The results of crossover trial were investigated by two-sample T-tests .


Strong positive correlations among DTI , VAS thirst score , XI and VAS xerostomia score were found ( P = 0.000 ) .


Daily IDWG was positively correlated with VAS thirst score ( r = 0.315 , P = 0.042 ) and DTI ( r = 0.391 , P = 0.010 ) .


UWS ( unstimulated whole saliva ) was negatively correlated with VAS xerostomia score ( r = -0.308 , P = 0.048 ) .


Residual urine output was negatively correlated with DTI ( r = -0.402 , P = 0.008 ) , VAS xerostomia score ( r = -0.461 , P = 0.002 ) and XI ( r = -0.403 , P = 0.008 ) .


In the crossover trial , DTI , XI , IDWG2d , IDWG3d , VAS thirst and xerostomia score were significantly reduced by the use of chewing gum ( P = 0.000 , 0.001 , 0.009 , 0.017 , 0.038 , 0.001 ) .


The VAS thirst score , DTI and IDWG3d were significantly reduced by receiveing straw ( P = 0.016 , 0.003 , 0.049 ) .


Thirst and xerostomia might affect the quality of life in MHD patients .


Both chewing gum and straw could decrease thirst and IDWG .


Cytarabine plays a pivotal role in the treatment of patients with acute myeloid leukemia ( AML ) .


Most centers use 7 to 10 days of cytarabine at a daily dose of 100 to 200 mg/m ( 2 ) for remission induction .


Consensus has not been reached on the benefit of higher dosages of cytarabine .


The European Organisation for Research and Treatment of Cancer ( EORTC ) and Gruppo Italiano Malattie Ematologiche dell ' Adulto ( GIMEMA ) Leukemia Groups conducted a randomized trial ( AML-12 ; Combination Chemotherapy , Stem Cell Transplant and Interleukin-2 in Treating Patients With Acute Myeloid Leukemia ) in 1,942 newly diagnosed patients with AML , age 15 to 60 years , comparing remission induction treatment containing daunorubicin , etoposide , and either standard-dose ( SD ) cytarabine ( 100 mg/m ( 2 ) per day by continuous infusion for 10 days ) or high-dose ( HD ) cytarabine ( 3,000 mg/m ( 2 ) every 12 hours by 3-hour infusion on days 1 , 3 , 5 , and 7 ) .


Patients in complete remission ( CR ) received a single consolidation cycle containing daunorubicin and intermediate-dose cytarabine ( 500 mg/m ( 2 ) every 12 hours for 6 days ) .


Subsequently , a stem-cell transplantation was planned .


The primary end point was survival .


At a median follow-up of 6 years , overall survival was 38.7 % for patients randomly assigned to SD cytarabine and 42.5 % for those randomly assigned to HD cytarabine ( log-rank test P = .06 ; multivariable analysis P = .009 ) .


For patients younger than age 46 years , survival was 43.3 % and 51.9 % , respectively ( P = .009 ; multivariable analysis P = .003 ) , and for patients age 46 to 60 years , survival was 33.9 % and 32.9 % , respectively ( P = .91 ) .


CR rates were 72.0 % and 78.7 % , respectively ( P < .001 ) and were 75.6 % and 82.4 % for patients younger than age 46 years ( P = .01 ) and 68.3 % and 74.8 % for patients age 46 years and older ( P = .03 ) .


Patients of all ages with very-bad-risk cytogenetic abnormalities and/or FLT3-ITD ( internal tandem duplication ) mutation , or with secondary AML benefitted from HD cytarabine .


HD cytarabine produces higher remission and survival rates than SD cytarabine , especially in patients younger than age 46 years .


Laparoscopic sphincter preservation for low rectal cancer is challenging because of the high risk of positive circumferential resection margin .


We hypothesized that perineal dissection of the distal rectum may improve quality of surgery , compared with the conventional abdominal dissection .


Between 2008 and 2012 , 100 patients with low rectal cancer ( < 6 cm from the anal verge ) suitable for sphincter preservation were randomized between perineal and abdominal low rectal dissection .


Surgery included laparoscopic mobilization of the left colon with high rectal dissection .


Distal rectal dissection was performed laparoscopically in the abdominal group and transanally in the perineal group .


The primary endpoint was quality of surgery ( circumferential resection margin , mesorectum grade , and lymph nodes ) .


Secondary end points were morbidity and conversion .


The rate of positive circumferential resection margin decreased significantly after perineal compared with abdominal low rectal dissection , 4 % versus 18 % ( P = 0.025 ) .


The mesorectum grade and the number of lymph nodes analyzed did not differ between the 2 groups .


There was no difference in surgical morbidity ( 12 % vs 14 % ; P = 0.766 ) and conversion ( 4 % vs 10 % ; P = 0.436 ) between perineal and abdominal rectal dissection .


Multivariate analysis showed that abdominal rectal dissection was the only independent factor of positive circumferential resection margin ( odds ratio = 5.25 ; 95 % confidence interval : 1.03-26 .70 ; P = 0.046 ) .


Perineal rectal dissection reduces the risk of positive circumferential resection margin , as compared with the conventional abdominal dissection in low rectal cancer .


This suggests the perineal rectal dissection as a new standard in laparoscopic sphincter-saving resection for low rectal cancer .


The objective of this prospective , multicenter study was to assess 1-year changes in sinonasal symptoms and health care use after office-based multisinus balloon dilation .


Adults diagnosed with chronic or recurrent acute rhinosinusitis per the 2007 adult sinusitis guidelines were enrolled in this Institutional Review Board-approved study .


Balloon dilation of the maxillary sinuses/ethmoid infundibula with or without frontal or sphenoid ostial dilation was performed in the physician 's office under local anesthesia .


Intraoperative procedure technical success and subject procedure tolerance were recorded .


Efficacy was assessed using the patient-reported 20-item Sino-Nasal Outcome Test ( SNOT-20 ) and Rhinosinusitis Symptom Inventory ( RSI ) .


Complications and revision surgeries were also recorded .


A total of 313 ostial dilations were attempted and 307 were successfully completed ( 98.1 % ) in 81 subjects .


Mean procedure tolerance was 2.8 2.2 ( 0 = no pain ; 10 = severe pain ) .


Clinically meaningful and statistically significant ( p < 0.0001 ) mean SNOT-20 symptom improvement was observed at 1 and 6 months and sustained through 1 year .


The RSI treatment effect for all major rhinosinusitis symptoms was `` large '' and improvement in each was significant ( p < 0.0001 ) .


Compared with the previous 1-year period , patients reported an average of 2.3 fewer acute sinus infections ( p < 0.0001 ) , 2.4 fewer antibiotic courses taken ( p < 0.0001 ) , and 3.0 fewer sinus-related physician visits ( p < 0.0001 ) after balloon dilation .


No serious device or procedure-related adverse events occurred .


One subject ( 1.3 % ) underwent revision surgery .


In-office , multisinus balloon dilation is safe , effective , and well tolerated .


Patients reported significant reductions in both sinonasal symptoms and health care use after balloon dilation .


Efficacy observed at 1 and 6 month follow-up was sustained through 1 year with a very low rate of revision surgery .


This study was a part of the clinical trial NCT01612780 registered at www.clinicaltrials.gov .


The present study tested whether taking into account both the reflective and the impulsive processes of physical activity ( PA ) is helpful in understanding how , and for whom , PA-promoting messages will be ( in ) effective in changing behavior .


Participants ( N = 101 ) were presented with a persuasive message promoting either PA ( experimental condition ) or healthy eating ( control condition ) .


Reflective intentions to be physically active were assessed both at baseline and after exposure to the message .


Impulsive approach tendencies toward PA ( IAPA ) and sedentary behaviors ( IASB ) were assessed using a manikin task .


The main outcome variable was accelerometer-assessed free time spent in moderate to vigorous physical activity ( MVPA ) over 1 week after exposure to the message .


Although the PA-promoting message had no direct effect on MVPA , the results showed that ( a ) this message increased intentions to practice PA , notably among participants with low or moderate ( but not high ) baseline intentions ; ( b ) objective MVPA was positively predicted by postmessage PA intentions and IAPA , and negatively predicted by IASB ; and ( c ) postmessage PA intentions predicted MVPA for individuals with low or moderate ( but not high ) IASB .


A follow-up moderated mediation analysis corroborated these earlier results , showing that PA-promoting messages positively predicted MVPA through postmessage intentions only among individuals with low or moderate baseline intentions and low or moderate IASB .


By identifying 2 boundary conditions , this study revealed important insights in explaining when PA-promoting messages will be effective to predict objective MVPA and when they will not .


Improving the use ( eg , initial visit and revisits ) of Internet-delivered interventions to promote healthy lifestyles such as non-smoking is one of the largest challenges in the field of eHealth .


Prompts have shown to be effective in stimulating reuse of Internet-delivered interventions among adults and adolescents .


However , evidence concerning effectiveness of prompts to promote reuse of a website among children is still scarce .


The aim of this study is to investigate ( 1 ) whether prompts are effective in promoting reuse of an intervention website containing information on smoking prevention for children , ( 2 ) whether the content of the prompt is associated with its effect in terms of reuse , and ( 3 ) whether there are differences between children who do or do not respond to prompts .


The sample of this cluster-randomized study consisted of 1124 children ( aged 10-11 years ) from 108 Dutch primary schools , who were assigned to the experimental group of an Internet-delivered smoking prevention intervention study .


All participants completed a Web-based questionnaire on factors related to ( non - ) smoking .


Schools were randomized to a no-prompt group ( n = 50 ) or a prompt group ( n = 58 ) .


All children could revisit the intervention website , but only the children in the prompt group received email and SMS prompts to revisit the website .


Those prompt messages functioned as a teaser to stimulate reuse of the intervention website .


Reuse of the website was objectively tracked by means of a server registration system .


Repeated measures analysis of variance and linear regression analysis were performed to assess the effects of prompts on website reuse and to identify individual characteristics of participants who reuse the intervention website .


Children in the prompt group reused the intervention website significantly more often compared to children in the no-prompt group ( B = 1.56 , P < .001 ) .


Prompts announcing new animated videos ( F1 ,1122 = 9.33 , P = .002 ) and games about ( non - ) smoking on the website ( F1 ,1122 = 8.28 , P = .004 ) resulted in most reuse of the website .


Within the prompt group , children with a low socioeconomic status ( SES ) reused the intervention website more often ( B = 2.19 , P < .001 ) than children of high SES ( B = 0.93 , P = .005 ) .


Prompts can stimulate children to reuse an intervention website aimed at smoking prevention .


Prompts showed , furthermore , to stimulate children of a low SES slightly more to reuse an intervention website , which is often a difficult target group in terms of stimulating participation .


However , the number of revisits was quite low , which requires further study into how prompts can be optimized in terms of content and frequency to improve the number of revisits .


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


Radial artery catheterization is gaining popularity for diagnostic and interventional procedures .


Palpation technique is widely used for the procedure , but ultrasonography has been shown to increase catheterization success .


A recently described ultrasonography technique is termed ` dynamic needle tip positioning ' .


We aimed to compare the traditional palpation technique and dynamic needle tip positioning technique in regard to clinically relevant end points .


The study was conducted as a randomized , patient-blinded , crossover study .


Patients underwent bilateral radial artery catheterization using both techniques .


The primary end point of the study was needle manipulation time .


Additional end points were ( 1 ) the number of skin perforations , ( 2 ) the number of attempts targeting the vessel , ( 3 ) the number of catheters placed in first attempt and ( 4 ) the number of catheters used .


Forty patients were analyzed .


There was no significant difference in median needle manipulation time [ 32 s ( range 11-96 s ) vs. 39 s ( range 9-575 s ) , P = 0.525 ] , although the variance was lower in the dynamic needle tip positioning group ( P < 0.001 ) .


In the traditional palpation technique group , a higher number of skin perforations ( 57 vs. 40 , P = 0.003 ) , catheters ( 46 vs. 40 , P = 0.025 ) and attempts targeting the vessel ( 104 vs. 43 , P < 0.001 ) were necessary compared with the ultrasonography dynamic needle tip positioning group .


First attempt success rate was significantly higher in the ultrasonography dynamic needle tip positioning group ( 23/40 vs. 38/40 , P < 0.001 ) .


Ultrasonography guidance using the dynamic needle tip positioning technique for radial artery catheterization significantly improves clinically relevant aspects of the procedure .


Postoperative pain control after total knee arthroplasty ( TKA ) remains a great challenge .


The management of pain in the immediate postoperative period is one of the most critical aspects to allow speedier rehabilitation and reduce the risk of postoperative complications .


Recently , periarticular infiltration anesthesia has become popular , but the outcome is controversial .


Some studies have shown transient effects , `` rebound pain '' , or no effectiveness in pain control .


Continuous intra-articular infusion technique has been introduced to improve these transient effects , but more clinical studies are needed .


Furthermore , the potential risk of early periprosthetic joint infection is causing concerning .


We plan to compare continuous intra-articular infusion anesthesia with epidural infusion anesthesia after TKA to assess the effectiveness of this technique in reducing pain , in improving postoperative function , and to look at the evidence for risk of early infection .


This trial is a randomized , controlled study .


Patients ( n = 214 ) will be randomized into two groups : to receive continuous intra-articular infusion anesthesia ( group C ) ; and epidural infusion anesthesia ( group E ) .


For the first 3 postoperative days , pain at rest , active range of motion ( A-ROM ) , rescue analgesia and side effects will be recorded .


At 3-month and 6-month follow-up , A-ROM , C-reactive protein , erythrocyte sedimentation rate , and synovial fluid cell count and culture will be analyzed .


The results from this study will provide clinical evidence on the efficacy of a continuous intra-articular infusion technique in reducing pain , postoperative functional improvement and safety .


It will be the first randomized controlled trial to investigate infection risk with local anesthesia after TKA .


ClinicalTrials.gov identifier : ChiCTR-TRC-13003999 .


Observational studies have shown that attentional bias for smoking-related cues is associated with increased craving and relapse .


Laboratory experiments have shown that manipulating attentional bias may change craving .


Interventions to reduce attentional bias could reduce relapse in smokers seeking to quit .