The US-RA technique for CEA induces temporary intraoperative hypertension and an increase in stress hormone levels .


Nevertheless , US-RA is a feasible , effective , and safe form of locoregional for CEA that enables targeted placement of low volumes of local anesthesia under direct visualization .


Adults living in the sunny Australian climate are at high risk of skin cancer , but vitamin D deficiency ( defined here as a serum 25-hydroxyvitamin D ( 25 ( OH ) D ) concentration of less than 50 nmol/L ) is also common .


Vitamin D deficiency may be a risk factor for a range of diseases .


However , the optimal strategies to achieve and maintain vitamin D adequacy ( sun exposure , vitamin D supplementation or both ) , and whether sun exposure itself has benefits over and above initiating synthesis of vitamin D , remain unclear .


The Sun Exposure and Vitamin D Supplementation ( SEDS ) Study aims to compare the effectiveness of sun exposure and vitamin D supplementation for the management of vitamin D insufficiency , and to test whether these management strategies differentially affect markers of immune and cardio-metabolic function .


The SEDS Study is a multi-centre , randomised controlled trial of two different daily doses of vitamin D supplementation , and placebo , in conjunction with guidance on two different patterns of sun exposure .


Participants recruited from across Australia are aged 18-64 years and have a recent vitamin D test result showing a serum 25 ( OH ) D level of 40-60 nmol/L .


This paper discusses the rationale behind the study design , and considers the challenges but necessity of data collection within a non-institutionalised adult population , in order to address the study aims .


We also discuss the challenges of participant recruitment and retention , ongoing engagement of referring medical practitioners and address issues of compliance and participant retention .


Australia New Zealand Clinical Trials Registry : ACTRN12613000290796 Registered 14 March 2013 .


Patching of the operative eye is occasionally used in pediatric strabismus surgery .


The primary purpose of this study was to investigate the psychological and physiologic effects of patching after operation by multifactorial methods .


We analyzed the perioperative behaviors of 61 children with strabismus conducted from June 2012 to July 2013 in this prospective longitudinal study .


The children were randomized into 2 groups .


Patients in the patching group underwent postoperative patching and others received no patching .


Main outcome measures included The Faces Pain Scale-Revised score or numerical rating scales score , Children 's Hospital of Eastern Ontario Pain Scale ( CHEOPS ) score , crying time , and preoperative and postoperative physiologic parameters .


Crying time was significantly longer in the patching group than in the no patching group , but self-report scores showed no difference in the groups .


Repeated-measures analysis of variance on ranks revealed that postoperative CHEOPS score was lower in the no patching group than in the patching group , whereas no physiologic parameters were significantly different in the 2 groups .


Patching is not necessary for reducing postoperative pain or the risk of infection in children undergoing strabismus surgery .


To assess the effect of a physical activity ( PA ) intervention on brain and behavioral indices of executive control in preadolescent children .


Two hundred twenty-one children ( 7-9 years ) were randomly assigned to a 9-month afterschool PA program or a wait-list control .


In addition to changes in fitness ( maximal oxygen consumption ) , electrical activity in the brain ( P3-ERP ) and behavioral measures ( accuracy , reaction time ) of executive control were collected by using tasks that modulated attentional inhibition and cognitive flexibility .


Fitness improved more among intervention participants from pretest to posttest compared with the wait-list control ( 1.3 mL/kg per minute , 95 % confidence interval [ CI ] : 0.3 to 2.4 ; d = 0.34 for group difference in pre-to-post change score ) .


Intervention participants exhibited greater improvements from pretest to posttest in inhibition ( 3.2 % , 95 % CI : 0.0 to 6.5 ; d = 0.27 ) and cognitive flexibility ( 4.8 % , 95 % CI : 1.1 to 8.4 ; d = 0.35 for group difference in pre-to-post change score ) compared with control .


Only the intervention group increased attentional resources from pretest to posttest during tasks requiring increased inhibition ( 1.4 V , 95 % CI : 0.3 to 2.6 ; d = 0.34 ) and cognitive flexibility ( 1.5 V , 95 % CI : 0.6 to 2.5 ; d = 0.43 ) .


Finally , improvements in brain function on the inhibition task ( r = 0.22 ) and performance on the flexibility task correlated with intervention attendance ( r = 0.24 ) .


The intervention enhanced cognitive performance and brain function during tasks requiring greater executive control .


These findings demonstrate a causal effect of a PA program on executive control , and provide support for PA for improving childhood cognition and brain health .


Recurrent and/or metastatic squamous cell carcinoma of the head and neck ( R/M-SCCHN ) overexpresses v5 integrin .


Cilengitide selectively inhibits v3 and v5 integrins and is investigated as a treatment strategy .


The phase I/II study ADVANTAGE evaluated cilengitide combined with cisplatin , 5-fluorouracil , and cetuximab ( PFE ) in R/M-SCCHN .


The phase II part reported here was an open-label , randomized , controlled trial investigating progression-free survival ( PFS ) .


Patients received up to six cycles of PFE alone or combined with cilengitide 2000 mg once ( CIL1W ) or twice ( CIL2W ) weekly .


Thereafter , patients received maintenance therapy ( cilengitide arms : cilengitide plus cetuximab ; PFE-alone arm : cetuximab only ) until disease progression or unacceptable toxicity .


One hundred and eighty-two patients were treated .


Median PFS per investigator read was similar for CIL1W + PFE , CIL2W + PFE , and PFE alone ( 6.4 , 5.6 , and 5.7 months , respectively ) .


Accordingly , median overall survival and objective response rates were not improved with cilengitide ( 12.4 months/47 % , 10.6 months/27 % , and 11.6 months/36 % , respectively ) .


No clinically meaningful safety differences were observed between groups .


None of the tested biomarkers ( expression of integrins , CD31 , Ki-67 , vascular endothelial growth factor receptor 2 , vascular endothelial-cadherin , type IV collagen , epidermal growth factor receptor , or p16 for human papillomavirus ) were predictive of outcome .


Neither of the cilengitide-containing regimens demonstrated a PFS benefit over PFE alone in R/M-SCCHN patients .


The purpose of this secondary analysis was to determine changes in physical inactivity from baseline to 5 years and to identify factors associated with and predictive of physical inactivity among individuals with type 2 diabetes enrolled in the Detection of Ischemia in Asymptomatic Diabetics ( DIAD ) study .


DIAD was a prospective randomized screening trial that assessed the prevalence of silent ischemia in asymptomatic patients with type 2 diabetes .


Subjects were recruited from diabetes and primary care practices at 14 centers throughout the United States and Canada .


This is a secondary data analysis of the physical activity data ( type and hours/week ) collected .


No intervention was conducted .


In all subjects , physical inactivity rose from 24 % at baseline to 33 % at 5 years ( S = 28.93 ; P < .0001 ) .


This change was significant in both men ( S = 11.44 ; P < .0001 ) , increasing from 23 % to 31 % , and women ( S = 18.05 ; P < .0001 ) , increasing from 25 % to 36 % .


Gender differences were noted in several factors associated with baseline physical inactivity as well as in factors predictive of physical inactivity at 5 years .


Important factors associated at both time points included lower level of education , current employment , presence of peripheral and autonomic neuropathy , and indicators of overweight/obesity .


Baseline physical inactivity was strongly predictive of physical inactivity at 5 years ( odds ratio , 3.27 ; 95 % confidence interval , 2.36-4 .54 ; P < .0001 ) .


Gender-related differences were noted in factors associated with and predictive of physical inactivity .


We have previously observed that intravaginal prasterone ( dehydroepiandrosterone , DHEA ) improved all domains of female sexual dysfunction ( FSD ) .


Investigate the influence of moderate/severe pain at sexual activity ( dyspareunia ) ( MSD ) at baseline on FSD following prasterone administration .


The effect of daily administration of prasterone ( 0 , 3.25 mg , 6.5 mg or 13mg ) for 12 weeks on FSD in 215 postmenopausal women with or without MSD at baseline was evaluated in a prospective , randomized , double-blind , and placebo-controlled phase III clinical trial .


Differences were examined on desire , arousal and orgasm .


Comparable benefits were observed in women not having MSD ( n = 56 ) vs. those having MSD ( n = 159 ) .


The benefits over placebo in prasterone-treated women for desire , avoiding intimacy and vaginal dryness as well as for the total sexual domain of the MENQOL ( Menopause Specific Quality of Life ) questionnaire , ranged between 18.0 % and 38.2 % with P values of < 0.05 or < 0.01 except in one out of 12 subgroups .


For the arousal/sensation , arousal/lubrication and summary score of the ASF ( Abbreviated Sexual Function ) questionnaire , in the MSD + group , improvements of 64.2 % ( P = 0.01 ) , 118 % ( P = 0.001 ) and 31.1 % ( P = 0.03 ) were observed over placebo , respectively , while similar differences ( 58.0 % , 67.6 % and 32.1 % ) did not reach statistical significance in the MSD - group having up to only 44 prasterone-treated women compared with 119 in the MSD + group .


No MSD at baseline does not apparently affect the effects of intravaginal prasterone on sexual dysfunction .


Knowing the absence of significant effects of estrogens on FSD , the present data suggest that vulvovaginal atrophy ( VVA ) and vulvovaginal sexual dysfunction ( VVSD ) are two different consequences of sex steroid deficiency at menopause which can respond independently .


In addition , the present data seriously question the justification of pain being part of FSD as well as the separation of FSD into separate domains .


Supportive supervision is a form of supervision that promotes quality at all levels of health system by strengthening relationships within the system through prompt identification and resolution of problems among others .


It is an effective intervention in improving health worker performance in low resource settings .


Malaria is responsible for majority of outpatient consultations in Nigeria at all levels of care .


This was a facility-based interventional study with pre and post-intervention phases conducted among two groups.The study subjects were selected through a multistage sampling technique and data collection was done using both semistructured interviewer administered questionnaire and supervisory checklist .


The mean knowledge scores of malaria within the intervention group showed an increase from 10.3 1.4 at preintervention to 11.3 1.5 at post-intervention ( P < 0.0015 ) .


The proportion of respondents who correctly followed malaria management guidelines increased from 32.73 % at first supervisory visit to 70.91 % by the third supervisory visit ( P < 0.001 ) .


An analysis of the supervisory checklist showed improvement in performance of healthcare workers with each supportive supervisory visit in most of the variables examined .


This study has demonstrated that supportive supervision is a feasible and practicable tool in improving knowledge and practice of malaria case management among PHC workers .


Functional neck/shoulder stiffness is one of the most well-known indications for acupuncture treatment in Japan .


There is little evidence for the effectiveness of acupuncture treatment for functional neck/shoulder stiffness .


Research using two different placebos may allow an efficient method to tease apart the components of real acupuncture from various kinds of ` non-specific ' effects such as ritual with touch or ritual alone .


Herein , we describe a protocol of an ongoing , single-centre , randomised , placebo-controlled trial which aims to assess whether , in functional neck/shoulder stiffness , acupuncture treatment with skin piercing has a specific effect over two types of placebo : skin-touching plus ritual or ritual alone .


Six acupuncturists and 400 patients with functional neck/shoulder stiffness are randomly assigned to four treatment groups : genuine acupuncture penetrating the skin , skin-touch placebo or no-touch placebo needles in a double-blind manner ( practitioner-patient blinding ) or no-treatment control group .


Each acupuncturist applies a needle to each of four acupoints ( Bladder10 , Small Intestine14 , Gallbladder21 and Bladder42 ) in the neck/shoulder to 50 patients .


Before , immediately after and 24 hours after the treatment , patients are asked about the intensity of their neck/shoulder stiffness .


After the treatment , practitioners and patients are asked to guess whether the treatment is `` penetrating '' , `` skin-touch '' or `` no-touch '' or to record `` can not identify the treatment '' .


In addition to intention-to-treat analysis , we will conduct subgroup analysis based on practitioners ' or patients ' guesses to discuss the efficacy and effectiveness of treatments with skin piercing and various placebo controls .


The results of practitioner and patient blinding will be discussed .


We believe this study will further distinguish the role of different components of acupuncture .


Current Controlled Trial ISRCTN76896018 .


The aim of this study was to compare the effects of 4 weeks of CT and AT , which training impulse ( total external workload and perceived exertion ) , are similar on power associated at VO2 peak ( pVO2 peak ) and cardiorespiratory responses of patient with CAD .


Eighteen male with CAD ( 62 7 years , 175 2 cm , 84 16 kg , fraction of ejection = 0.49 0.16 ) performed 4 weeks of CT ( n = 9 ) or AT ( n = 9 ) .


pVO2 peak , maximal and first ventilatory threshold values of oxygen uptake ( VO2 peak , VO2-vt ) and heart rate ( HRmax , HR-vt ) were measured before and after training session .


Total training impulse ( exercise rehabilitation and other paramedical actions ) were evaluated and harmonized between AT and CT according to Foster et al. formula ( 1996 ) RESULTS : No significant difference were found in training impulse between AT and CT ( 3650 220 vs 3497 190 U , P = NS ) .


VO2 pic increased after AT ( 16.9 4.4 vs 18.9 4.9 mL O2/min/kg , P < 0.05 ) and remained unchanged after CT ( 17.7 7.8 vs 17.8 7.2 , P = NS ) .


Four weeks of training induced significant increase in pVO2 peak , VO2-vt and FC-vt , expressed in absolute or relative value ( P < 0,05 ) , without any difference between AT and CT modalities ( P = NS ) .


Improving pVO2 pic following an exercise training does not necessarily preclude an improvement in coronary VO2 pic .


pVO2 peak was not improved with the same cardiorespiratory adaptations between AT and CT. .


Thus , there seems important to measure gas exchanges of subject with CAD during the incremental test and identify the respective part of muscular and cardiorespiratory functions in exercise exhaustion .


The UK lags behind many European countries in terms of cancer survival .


Initiatives to address this disparity have focused on barriers to presentation , symptom recognition , and referral for specialist investigation .


Selection of patients for further investigation has come under particular scrutiny , although preferences for referral thresholds in the UK population have not been studied .


We investigated preferences for diagnostic testing for colorectal , lung , and pancreatic cancers in primary-care attendees .


In a vignette-based study , researchers recruited individuals aged at least 40 years attending 26 general practices in three areas of England between Dec 6 , 2011 , and Aug 1 , 2012 .


Participants completed up to three of 12 vignettes ( four for each of lung , pancreatic , and colorectal cancers ) , which were randomly assigned .


The vignettes outlined a set of symptoms , the risk that these symptoms might indicate cancer ( 1 % , 2 % , 5 % , or 10 % ) , the relevant testing process , probable treatment , possible alternative diagnoses , and prognosis if cancer were identified .


Participants were asked whether they would opt for diagnostic testing on the basis of the information in the vignette .


3469 participants completed 6930 vignettes .


3052 individuals ( 88 % ) opted for investigation in their first vignette .


We recorded no strong evidence that participants were more likely to opt for investigation with a 1 % increase in risk of cancer ( odds ratio [ OR ] 102 , 95 % CI 099-106 ; p = 0189 ) , although the association between risk and opting for investigation was strong when colorectal cancer was analysed alone ( 108 , 103-113 ; p = 00001 ) .


In multivariable analysis , age had an effect in all three cancer models : participants aged 60-69 years were significantly more likely to opt for investigation than were those aged 40-59 years , and those aged 70 years or older were less likely .


Other variables associated with increased likelihood of opting for investigation were shorter travel times to testing centre ( colorectal and lung cancers ) , a family history of cancer ( colorectal and lung cancers ) , and higher household income ( colorectal and pancreatic cancers ) .


Participants in our sample expressed a clear preference for diagnostic testing at all risk levels , and individuals want to be tested at risk levels well below those stipulated by UK guidelines .


This willingness should be considered during design of cancer pathways , particularly in primary care .


The public engagement with our study should encourage general practitioners to involve patients in referral decision making .


The National Institute for Health Research Programme Grants for Applied Research programme .


Little is known about the benefit of antiviral therapy for hepatitis B e antigen ( HBeAg ) - positive patients with high viral load and normal levels of alanine aminotransferase .


We evaluated the effects of single and combination therapies in immune-tolerant patients with chronic hepatitis B.


In a double-blind study , nucleos ( t ) ide-nave patients with high levels of hepatitis B virus ( HBV ) DNA who were positive for HBeAg and had normal levels of alanine aminotransferase were randomly assigned to groups given either oral tenofovir disoproxil fumarate ( TDF , 300 mg ) and placebo ( n = 64 ) or a combination of TDF ( 300 mg ) and emtricitabine ( 200 mg , n = 62 ) for 192 weeks .


The primary end point was proportion of patients with serum levels of HBV DNA < 69 IU/mL at week 192 .


The study population ( mean age was 33 years ; 89 % were Asian ) was predominantly infected with HBV genotypes B and C ( 93 % ) , 99 % were HBeAg positive with a mean baseline level of HBV DNA of 8.41 log10 IU/mL .


At week 192 , 55 % of patients ( 35 of 64 ) in the TDF + placebo group and 76 % of patients ( 47 of 62 ) in the TDF + emtricitabine group had levels of HBV DNA < 69 IU/mL ( P = .016 ) .


No patients were found to have viral resistance to therapy .


HBeAg seroconversion occurred in 3 patients ( 5 % ) , all in the TDF + placebo group ; no patient had loss of hepatitis B surface antigen .


In multivariate analysis , female sex ( odds ratio = 7.05 ; P = .002 ) and TDF + emtricitabine treatment ( odds ratio = 3.9 ; P = .01 ) were associated with a favorable response .


Both regimens were well tolerated .


In HBeAg-positive patients with chronic HBV infection , high viral loads , normal levels of alanine aminotransferase , and therapy with the combination of TDF and emtricitabine provided better viral suppression than TDF alone , although rates of HBeAg seroconversion and hepatitis B surface antigen loss were low .


Routine immunization is a key child survival intervention .


Issues related to quality of service delivery pose operational challenges in delivering effective immunization services .


Accumulated evidences suggest that `` supportive supervision '' improves the quality of health care services .


During 2009-10 , Govt .


of Odisha ( GoO ) and UNICEF jointly piloted this strategy in four districts to improve routine immunization .


The present study aims to assess the effect of supportive supervision strategy on improvement of knowledge and practices on routine immunization among service providers .


We adopted a ` post-test only ' study design to compare the knowledge and practices of frontline health workers and their supervisors in four intervention districts with that of two control districts .


Altogether we interviewed 170 supervisors and supervisees ( health workers ) , each , using semi-structured interview schedules .


We also directly observed 25 ice lined refrigerator ( ILR ) points in both groups of districts .


The findings were compared with the baseline information , available only for the intervention districts .


The health workers in the intervention districts displayed a higher knowledge score in selected items than in the control group .


No significant difference in knowledge was observed between control and intervention supervisors .


The management practices at ILR points on key routine immunization components were found to have improved significantly in intervention districts .


The observed improvements in the ILR management practices indicate positive influence of supportive supervision .


Higher level of domain knowledge among intervention health workers on specific items related to routine immunization could be due to successful transfer of knowledge from supervisors .


A ` pre-post ' study design should be undertaken to gain insights into the effectiveness of supportive supervision in improving routine immunization services .


Previous global studies examined etanercept ( ETN ) + methotrexate ( MTX ) for treatment of rheumatoid arthritis ( RA ) , but included few subjects from Latin America .


The objective of this study was to compare the safety and efficacy of ETN + MTX versus a standard-of-care disease-modifying antirheumatic drug ( DMARD ) + MTX in Latin American subjects with moderate to severe active RA despite MTX therapy .


This open-label , active-comparator study ( NCT00848354 ) randomized subjects 2:1 to ETN 50 mg/wk + MTX or investigator-selected DMARD ( sulfasalazine or hydroxychloroquine ) + MTX ( ETN + MTX , n = 281 ; DMARD + MTX , n = 142 ) .


The primary end point was the proportion achieving American College of Rheumatology ( ACR ) 50 at week 24 .


Secondary end points included ACR20/70 , disease activity score ( DAS ) 28 measures , and mean change in modified total Sharp score .


Patient-reported outcomes were the Health Assessment Questionnaire , 36-item Short-Form , Hospital Anxiety and Depression Scale , Work Productivity and Activity Impairment : RA ( WPAI : RA ) , and Caregiver Burden and Resource Utilization .


Statistical analyses were stratified by country ; test and analysis of covariance were used .


Adverse events were monitored .


More subjects achieved ACR50 at week 24 with ETN + MTX versus DMARD + MTX ( 62 % vs 23 % , respectively ) , in addition to secondary end points ( P < 0.0001 for all ) ; mean change in modified total Sharp score was lower for the ETN + MTX group ( 0.4 vs 1.4 , respectively ; P = 0.0270 ) .


Improvements in patient-reported outcomes favored ETN + MTX for Health Assessment Questionnaire , 36-item Short-Form , Hospital Anxiety and Depression Scale for depression , WPAI : RA , and Caregiver Burden and Resource Utilization emergency department visits for RA ( P < 0.01 ) .


Overall , adverse events were similar between the groups ( 69 % vs 68 % , ) ; serious adverse events were also similar ( 4 % vs 1 % ) .


The rate of overall infections was higher with ETN + MTX ( 38 % ) than DMARD + MTX ( 22 % , P 0.001 ) .


Consistent with published global data among RA patients with inadequate response to MTX , adding ETN to MTX demonstrated better efficacy than adding one other conventional DMARD to MTX .


No new safety issues were observed .


ETN + MTX provided favorable benefit-risk profile among RA patients from LA region .


Despite national guidelines recommending bone mineral density screening with dual-energy x-ray absorptiometry ( DXA ) in women aged 65 years and older , many women do not receive initial screening .


To determine the effectiveness of health system and patient-level interventions designed to increase appropriate DXA testing and osteoporosis treatment through ( 1 ) an invitation to self-refer for DXA ( self-referral ) ; ( 2 ) self-referral plus patient educational materials ; and ( 3 ) usual care ( UC , physician referral ) .


Parallel , group-randomized , controlled trials performed at Kaiser Permanente Northwest ( KPNW ) and Kaiser Permanente Georgia ( KPG ) .


Women aged 65 years and older without a DXA in past 5 years .


DXA completion rates 90 days after intervention mailing and osteoporosis medication receipt 180 days after initial intervention mailing .


From > 12,000 eligible women , those randomized to self-referral were significantly more likely to receive a DXA than UC ( 13.0 % -24.1 % self-referral vs. 4.9 % -5.9 % UC , P < 0.05 ) .


DXA rates did not significantly increase with patient educational materials .


Osteoporosis was detected in a greater proportion of self-referral women compared with UC ( P < 0.001 ) .


The number needed to receive an invitation to result in a DXA in KPNW and KPG regions was approximately 5 and 12 , respectively .


New osteoporosis prescription rates were low ( 0.8 % -3.4 % ) but significantly greater among self-referral versus UC in KPNW .


DXA rates significantly improved with a mailed invitation to schedule a scan without physician referral .


Providing women the opportunity to self-refer may be an effective , low-cost strategy to increase access for recommended osteoporosis screening .


Budesonide formoterol ( BF ) Spiromax is a breath-actuated dry-powder inhaler designed to deliver similar combinations of budesonide and formoterol as Symbicort Turbohaler .


We performed two studies to demonstrate pharmacokinetic ( PK ) equivalence of BF Spiromax with BF Turbohaler .


Two single-center , open-label , randomized , 5-period crossover studies were performed .


The first study compared BF Spiromax 160/4 .5 g with BF Turbohaler 200/6 g , while the second study compared BF Spiromax 320/9 g with BF Turbohaler 400/12 g. All treatments were administered with and without charcoal .


PK parameters were calculated by measuring plasma drug concentrations from blood samples taken pre-dose and up to 24 hours post-dose .


In each study , 90 healthy volunteers were randomized .


Bioequivalence of BF Spiromax with BF Turbohaler was demonstrated for budesonide and formoterol ( AUC0-t and Cmax ( 90 % confidence intervals of the geometric mean between-device ratios for both parameters were within the predefined range of 0.80-1 .25 in both studies ) ) .


Equivalence was observed without use of charcoal ( overall absorption post-inhalation ) and with charcoal ( pulmonary absorption ) .


There were no major differences between treatments in tmax for either budesonide or formoterol .


All study treatments were well tolerated ( one treatment-emergent adverse event ( TEAE ) in the medium-dose study and four TEAEs in the high-dose study ) .


These studies indicate that BF Spiromax ( charcoal block ) is bioequivalent to BF Turbohaler with respect to the PK parameters assessed .


Single doses of BF Spiromax were well tolerated ; the overall safety profile of BF Spiromax and BF Turbohaler was similar .


Noncystic fibrosis bronchiectasis ( NCFB ) is characterized by airway expansion and recurrent acute exacerbations .


Macrolide has been shown to exhibit anti-inflammatory effects in some chronic airway diseases .


To assess the efficacy of roxithromycin on airway inflammation and remodeling in patients with NCFB under steady state .


The study involved an open-label design in 52 eligible Chinese patients with NCFB , who were assigned to control ( receiving no treatment ) and roxithromycin ( receiving 150mg/day for 6 months ) groups .


At baseline and 6 months , the inflammatory markers such as interleukin - ( IL - ) 8 , neutrophil elastase ( NE ) , matrix metalloproteinase - ( MMP ) 9 , hyaluronidase ( HA ) , and type IV collagen in sputum were measured , along with the detection of dilated bronchus by throat computed tomography scan , and assessed the exacerbation .


Forty-three patients completed the study .


The neutrophil in the sputum was decreased in roxithromycin group compared with control ( P < 0.05 ) .


IL-8 , NE , MMP-9 , HA , and type IV collagen in sputum were also decreased in roxithromycin group compared with the control group ( all P < 0.01 ) .


Airway thickness of dilated bronchus and exacerbation were reduced in roxithromycin group compared with the control ( all P < 0.05 ) .


Roxithromycin can reduce airway inflammation and airway thickness of dilated bronchus in patients with NCFB .


CAM2028 , a vehicle that forms a bioadhesive lipid barrier when applied to the oral mucosa , was developed as a carrier system for local delivery of benzydamine , an NSAID used for pain relief in oral mucositis .


This trial compared the analgesic effect of CAM2028 plus benzydamine ( CAM2028-benzydamine ) with unmedicated CAM2028 ( CAM2028-control ) for the treatment of oral mucositis in patients with head-and-neck cancer .


Thirty-eight study participants were enrolled during their 3rd to 4th week of radiation therapy .


Participants were required to have symptomatic oral mucositis ( WHO Grade 2 or above ) at screening and pain scores of at least 6 on an 11-point Likert scale at screening and on each day before treatment with study medication .


After undergoing radiation , patients were administered a single dose of CAM2028-control or CAM2028-benzydamine 2 days apart , in a randomized crossover fashion .


Pain was assessed over the following 8 h.


With both treatments , patients experienced a mean 40 % decrease in pain intensity at 6 h ( the primary study endpoint ) .


Both treatments resulted in significant pain relief within 5 min of application that was evident during the entire 8-h assessment period .


There was no difference in pain relief between the two interventions at any time point .


Both treatments were safe and well tolerated .


CAM2028-benzydamine and CAM2028-control were both efficacious in reducing pain in patients with oral mucositis related to radiation therapy for head-and-neck cancer .


Analgesic effects of both medications were immediate , clinically significant , and persistent for up to 8 h.


The aim of this study was to characterize trastuzumab population pharmacokinetics ( PKs ) in patients with human epidermal growth factor receptor 2-positive advanced gastric or gastroesophageal junction cancer and the relationship of trastuzumab PK with patient response .


A nonlinear mixed effects PK model was built using data from the ToGA study .


Patients were randomized to intravenous trastuzumab plus chemotherapy or chemotherapy alone .


The influence of demographic , laboratory , and disease characteristics on PK parameters was assessed .


An exploratory exposure-response analysis compared various PK parameters at steady state with best overall tumor response and overall survival ( OS ) .


Trastuzumab PK was best described by a two-compartment model with parallel linear and nonlinear ( Michaelis-Menten ) elimination from the central compartment .


Total clearance ( and half-life ) of trastuzumab was concentration-dependent .


Body weight , prior gastrectomy , and serum albumin had the greatest influence on trastuzumab PK ; increasing weight and decreasing albumin levels were associated with increased clearance , while prior gastrectomy correlated with decreased clearance .


Median values for AUC , Cmax , and Cmin were lower in patients with progressive disease ( PD ) than other response categories , although the 1.5 interquartile ranges overlapped .


Patients with the lowest Cmin had the highest PD rate and a shorter OS .


In the advanced gastric cancer population , trastuzumab PK was best described by a two-compartment model with parallel linear and nonlinear elimination .


Predicted PK exposure was lower than previously reported for breast cancer .


Patients with the lowest Cmin had a shorter OS and the highest PD rate , but a distinct correlation was not observed for tumor response .


Whilst surgery will face an imminent workforce shortage , an increasing majority of students decide against a surgical career .


This study evaluated the current career expectations of medical students and tested a hands-on virtual reality ( VR ) intervention as a tool to increase their interest in surgery .


Randomly selected medical students of the University of Basel received a short questionnaire to rank their interest in five different postgraduate working environments prior to a lecture .


After the lecture they participated in a hands-on VR demonstration .


Thereafter an online questionnaire regarding workplace expectations , surgery and VR was sent to the students .


The online questionnaire response rate was 87 % ( 225/258 ) .


Before using the VR intervention , a nonsurgical career was preferred by the majority of students , followed by a surgical career , cross-disciplinary specialties , research and , finally , nonclinical work .


Surgery ( n = 99 , 44 % ) and emergency medicine ( n = 111 , 49 % ) were rated as incompatible with a good work-life balance .


Further drawbacks to surgery were apprehension of competitive mentality , unclear career perspectives and longer working hours .


The VR intervention had limited impact on re-ranking the five working sectors and slightly increased the students ' interest in surgery .


Students ' work environment expectations , their declining interest in a surgical career and the increasing need for surgeons represent challenges for surgical societies to address , in order to improve the attractiveness of surgery amongst students .


VR sessions may be integrated as part of the actions required to improve students ' interest in a surgical career and should be further evaluated within controlled study designs .


The comparative efficacy and safety of infliximab and azathioprine therapy alone or in combination for ulcerative colitis ( UC ) have not been evaluated previously .


This randomized , double-blind trial evaluated the efficacy and safety of 16 weeks of treatment with infliximab monotherapy , azathioprine monotherapy , or the 2 drugs combined in tumor necrosis factor-a antagonist-naive adults with moderate to severe UC .


Patients were assigned randomly to receive intravenous infusions of infliximab 5 mg/kg at weeks 0 , 2 , 6 , and 14 plus daily oral placebo capsules ; oral azathioprine 2.5 mg/kg daily plus placebo infusions on the infliximab schedule ; or combination therapy with the 2 drugs .


Corticosteroid-free clinical remission ( primary end point , week 16 ) was evaluated at weeks 8 and 16 .


The study was terminated before the enrollment target was reached .


A total of 239 patients were included in efficacy analyses .


Baseline characteristics were similar between treatment groups .


Corticosteroid-free remission at week 16 was achieved by 39.7 % ( 31 of 78 ) of patients receiving infliximab/azathioprine , compared with 22.1 % ( 17 of 77 ) receiving infliximab alone ( P = .017 ) and 23.7 % ( 18 of 76 ) receiving azathioprine alone ( P = .032 ) .


Mucosal healing at week 16 occurred in 62.8 % ( 49 of 78 ) of patients receiving infliximab/azathioprine , compared with 54.6 % ( 42 of 77 ) receiving infliximab ( P = .295 ) and 36.8 % ( 28 of 76 ) receiving azathioprine ( P = .001 ) .


Serious infections occurred in 2 patients ( 1 patient receiving infliximab , and 1 patient receiving azathioprine ) .


Antitumor necrosis factor-anaive patients with moderate to severe UC treated with infliximab plus azathioprine were more likely to achieve corticosteroid-free remission at 16 weeks than those receiving either monotherapy .


Combination therapy led to significantly better mucosal healing than azathioprine monotherapy .


ClinicalTrials.gov number , NCT00537316 .


Prolonged duration of cardiopulmonary bypass aggravates the degree of inflammation and coagulopathy .


We investigated the influence of 6 % hydroxyethyl starch ( HES ) 130/0 .4 on coagulation and inflammation compared with albumin when used for both cardiopulmonary bypass priming and perioperative fluid therapy in patients undergoing complex valvular heart surgery .


Fifty four patients were randomly allocated into albumin-HES , albumin-nonHES , and HES-HES groups .


The cardiopulmonary bypass circuit was primed with 5 % albumin in the albumin-HES and albumin-nonHES group , and with HES in the HES-HES group .


As perioperative fluid , only plasmalyte was used in the albumin-nonHES group whereas HES was used up to 20 mL/kg in the albumin-HES and albumin-HES group .


Serial assessments of coagulation profiles using the rotational thromboelastometry and inflammatory markers ( tissue necrosis factor - , interleukin-6 , and interleukin-8 ) were performed .


Patients ' characteristics and the duration of cardiopulmonary bypass ( albumin-HES ; 13734 min , HES-HES ; 13647 min , albumin-nonHES ; 13239 min ) were all similar among the groups .


Postoperative coagulation profiles demonstrated sporadic increases in clot formation time and coagulation time , without any differences in the actual amount of perioperative bleeding and transfusion requirements among the groups .


Also , inflammatory markers showed significant activation after cardiopulmonary bypass without any differences among the groups .


Even in the presence of prolonged duration of cardiopulmonary bypass , HES seemed to yield similar influence on the ensuing coagulopathy and inflammatory response when used for priming and perioperative fluid therapy following complex valvular heart surgery compared with conventional fluid regimen including albumin and plasmalyte .


To assess the reproducibility of brain-activation and eye-movement patterns in a saccade paradigm when comparing subjects , tasks , and magnetic resonance ( MR ) systems .


Forty-five healthy adults at two different sites ( n = 45 ) performed saccade tasks with varying levels of target predictability : predictable ( PRED ) , position predictable ( pPRED ) , time predictable ( tPRED ) , and prosaccade ( SAC ) .


Eye-movement pattern was tested with a repeated-measures analysis of variance .


Activation maps reproducibility were estimated with the cluster overlap Jaccard index and signal variance coefficient of determination for within-subjects test-retest data , and for between-subjects data from the same and different sites .


In all groups latencies increased with decreasing target predictability : PRED < pPRED < tPRED < SAC ( P < 0,001 ) .


Activation overlap was good to fair ( > 0.40 ) in all tasks in the within-subjects test-retest comparisons and poor ( < 0.40 ) in the tPRED for different subjects .


The overlap of the different tasks for within-groups data was higher ( 0.40-0 .68 ) than for the between-groups data ( 0.30-0 .50 ) .


Activation consistency was 60-85 % in the same subjects , 50-79 % in different subjects , and 50-80 % in different sites .


In SAC , the activation found in the same and in different subjects was more consistent than in other tasks ( 50-80 % ) .


The predictive saccade tasks produced evidence for brain-activation and eye-movement reproducibility .


The cortisol awakening response ( CAR ) is a natural metabolic response that can be potentiated by negative cognitive-emotional processes , including stress appraisals , negative affect , and rumination .


Psychological distress and the CAR are not consistently related , however .


Individual differences in aspects of dispositional mindfulness which reflect how people relate to negative thoughts and emotions may help explain such inconsistencies .


We tested whether the tendency to ( 1 ) label and describe inner experiences and ( 2 ) accept negative thoughts and feelings without judgment moderated the association between psychological distress and the CAR .


Self-reported dispositional mindfulness , perceived stress , anxiety , negative affect , rumination , and the CAR were assessed among overweight/obese women .


Regression analyses were conducted to examine whether dispositional mindfulness moderated the relationship between indicators of psychological distress and the CAR .


While psychological distress was consistently positively related to the CAR , these associations were qualified by significant interactions with both components of dispositional mindfulness .


Psychological distress was associated with the CAR at lower levels of dispositional mindfulness but not at higher levels .


These findings are consistent with the idea that the tendency to describe and accept experiences may buffer the impact of psychological distress on physiological arousal .


These metacognitive processes may be important moderators in unraveling the complex relationship between psychological distress and physiological stress reactivity .


Further research is recommended to replicate this approach in other populations .


To evaluate intra-articular autologous protein solution ( APS ) for the treatment of osteoarthritis in horses .


Animals-40 client-owned horses with naturally occuring osteoarthritis .


APS was generated from a dual-device system that concentrated plasma and WBC proteins and enriched platelet growth factors .


Horses were randomly assigned to receive an intra-articular injection of 5 mL of saline ( 0.9 % NaCl ) solution ( n = 20 ) or APS ( 20 ) , exercised on a treadmill , and evaluated on the basis of lameness grades , kinetic gait analysis , joint circumference , and range of motion for 14 days .


Horses that received saline solution were administered APS at termination of the study , and clients scored horses for lameness and discomfort before , 12 weeks after , and 52 weeks after the APS injection .


The APS group had significant improvements in lameness grade , asymmetry indices of vertical peak force , and range of joint motion by 14 days , compared with baseline or control group values .


No adverse effects associated with APS treatment were evident .


Clients assessed lameness and comfort as improved at 12 and 52 weeks .


The APS had greater likelihood ( OR , 4.3 to 30.0 ) of a therapeutic response in horses with a lameness score < 4 , < 10 % vertical force asymmetry , or absence of marked osteophyte formation , subchondral sclerosis , or joint space narrowing .


Concentration of interleukin-1 receptor antagonist in APS was 5.8 times that in blood .


Intra-articular administration of APS can be considered an effective treatment option for equine osteoarthritis , with the potential for disease-modifying effects .


Consistent evidence suggests that obstructive sleep apnoea ( OSA ) is associated with increased cardiovascular risk .


However , it is unclear whether OSA is underdiagnosed in the cardiology outpatient setting .


In the present study , we prospectively evaluated the potential underdiagnosis of OSA in several subspecialties from a tertiary cardiology university hospital .


Consecutive outpatients from five subspecialties ( hypertension , coronary , arrhythmia , heart failure ( HF ) , valvular heart disease ) were studied .


We performed anthropometric measurements , assessed the risk of OSA using the Berlin Questionnaire and evaluated the prior diagnosis and treatment for OSA .


In a subset of patients randomly selected , we performed portable sleep monitoring to objectively evaluate the presence of OSA ( defined by an apnoea-hypopnoea index 15 events/h of sleep ) .


We evaluated 500 patients ( 100 from each subspecialty ) .


The mean age and body mass index ( BMI ) were 5913years and 28.25.3 kg/m ( 2 ) , respectively .


We found that 51.6 % ( 258 patients ) had a high risk for OSA ( Berlin Questionnaire ) .


However , only 13 ( 3.1 % ) of these patients had a previous diagnosis of OSA .


Of those , only six patients were receiving specific OSA treatment .


Fifty patients ( 10 from each specialty ) participated in sleep studies .


No differences were found in patients who underwent sleep monitoring and those who did not .


We found a high frequency of OSA ( 66 % ) , varying from 50 % ( hypertension group ) to 80 % ( HF group ) .


Despite significant scientific evidence pointing to OSA as an emerging cardiovascular risk factor , OSA is still underdiagnosed in several cardiology subspecialties .


To compare two concentrations of ropivacaine administered for tumescent local anesthesia ( TLA ) in dogs undergoing mastectomy .


Prospective randomized clinical study .


Seventeen bitches of various breeds , aged 122years and weighing 106.5 kg requiring total unilateral or bilateral mastectomy .


Dogs were premedicated with acepromazine ( 0.04 mgkg ( -1 ) ) and morphine ( 0.4 mgkg ( -1 ) ) intramuscularly .


Anesthesia was induced with propofol ( 2.5 mgkg ( -1 ) ) and midazolam ( 0.2 mgkg ( -1 ) ) intravenously , followed by intubation and maintenance with isoflurane and TLA .


Dogs were randomly allocated to receive TLA either with 0.1 % ropivacaine ( group G1 ) or with 0.05 % ropivacaine ( group G05 ) .


TLA was performed by insertion of a multihole needle under the skin and infusion of ropivacaine and lactated Ringer 's solution at a fixed volume of 15mLkg ( -1 ) .


Ropivacaine concentrations in arterial blood were measured by high-performance liquid chromatography .


Post-operative pain was assessed using two scales ( University of Melbourne pain scale and a modified composite measure pain scale ) and von Frey filaments , 4hours after TLA and at 1hour intervals until sensitivity was regained .


A score above 30 % of the maximum possible score was considered a positive indicator of pain .


Peak plasma concentrations of ropivacaine were measured 240minutes after TLA in G1 .


Low concentrations were measured in G05 for 60minutes , with subsequent increase .


Analgesic rescue and return of sensitivity occurred at 72.3 and 71.9 hours ( mean SD ) after TLA for G1 and G05 , respectively .


Tumescent local anesthesia with ropivacaine provided satisfactory post-operative analgesia that lasted for several hours , with no difference in duration between the concentrations .


No serious side effects were attributed to TLA .


Results indicated that 0.05 % ropivacaine provided adequate analgesia for mastectomy , however , more studies are required to support this conclusion .


ST-segment resolution ( STR ) after reperfusion therapy has been shown to correlate with prognosis in patients with ST-segment elevation myocardial infarction ( STEMI ) .


We investigated whether acute ECG measurements also correlate with ultimate infarct size .


The INFUSE-AMI trial randomized 452 patients with anterior STEMI to intracoronary bolus abciximab vs. no abciximab , and to thrombus aspiration vs. no aspiration .


Infarct size as percentage of total LV mass was calculated by cardiac magnetic resonance imaging ( MRI ) 30 days post intervention .


Five ECG methods were analysed for their ability to predict MRI infarct mass : ( 1 ) summed STR across all infarct-related ECG leads ( STR ) ; ( 2 ) STR in the single lead with maximum baseline ST-segment elevation ( maxSTR ) ; ( 3 ) summed residual ST-segment elevation across all infarct-related leads at 60 min post intervention ( ST residual ) ; ( 4 ) maximum residual ST-segment elevation in the worst single lead at 60 min post intervention ( maxST residual ) ; ( 5 ) number of new significant Q-waves ( Qwave ) at 60 min .


All ECG methods strongly correlated with 30-day MRI infarct mass ( all p < 0.003 ) .


Simpler ECG measurements such as maxSTresidual and Qwave were as predictive as more complex measurements .


A subset analysis of 158 patients who had microvascular obstruction ( MVO ) determined by MRI 5 days post intervention also showed strong correlations of MVO with the ECG measures .


ST-segment and Q-wave changes after primary PCI in anterior STEMI strongly correlated with 30-day infarct size by MRI .


In particular , maxST residual and Qwave at 60 min are simple ECG parameters that offer rapid analysis for prognostication .


The quality of evidence for invasive revascularization in intermittent claudication is low or very low .


This prospective , randomized , controlled study tested the hypothesis that an invasive treatment strategy versus continued noninvasive treatment improves health-related quality of life after 1 year in unselected patients with intermittent claudication .


After clinical and duplex ultrasound assessment , unselected patients with intermittent claudication requesting treatment for claudication were randomly assigned to invasive ( n = 79 ) or noninvasive ( n = 79 ) treatment groups .


Primary end point was health-related quality of life after 1 year , assessed with Medical Outcomes Study Short Form 36 version 1 and Vascular Quality of Life Questionnaire , and secondary end points included walking distances on a graded treadmill .


The Medical Outcomes Study Short Form 36 version 1 physical component summary ( P < 0.001 ) and 2 Medical Outcomes Study Short Form 36 version 1 physical subscales improved significantly more in the invasive versus the noninvasive treatment group .


Overall , Vascular Quality of Life Questionnaire score ( P < 0.01 ) and 3 of 5 domain scores improved significantly more in the invasive versus the noninvasive treatment group .


Intermittent claudication distance improved significantly in the invasive ( +124 m ) versus the noninvasive ( +50 m ) group ( P = 0.003 ) , whereas the change in maximum walking distance was not significantly different between groups .


An invasive treatment strategy improves health-related quality of life and intermittent claudication distance after 1 year in patients with stable lifestyle-limiting claudication receiving current medical management .


Long-term follow-up data and health-economic assessments are warranted to further establish the role for revascularization in intermittent claudication .


Macrosomic fetuses are at increased risk of shoulder dystocia .


We aimed to compare induction of labour with expectant management for large-for-date fetuses for prevention of shoulder dystocia and other neonatal and maternal morbidity associated with macrosomia .


We did this pragmatic , randomised controlled trial between Oct 1 , 2002 , and Jan 1 , 2009 , in 19 tertiary-care centres in France , Switzerland , and Belgium .


Women with singleton fetuses whose estimated weight exceeded the 95th percentile , were randomly assigned ( 1:1 ) , via computer-generated permuted-block randomisation ( block size of four to eight ) to receive induction of labour within 3 days between 37 ( +0 ) weeks and 38 ( +6 ) weeks of gestation , or expectant management .


Randomisation was stratified by centre .


Participants and caregivers were not masked to group assignment .


Our primary outcome was a composite of clinically significant shoulder dystocia , fracture of the clavicle , brachial plexus injury , intracranial haemorrhage , or death .


We did analyses by intention to treat .


This trial is registered with ClinicalTrials.gov , number NCT00190320 .


We randomly assigned 409 women to the induction group and 413 women to the expectant management group , of whom 407 women and 411 women , respectively , were included in the final analysis .


Mean birthweight was 3831 g ( SD 324 ) in the induction group and 4118 g ( 392 ) in the expectant group .


Induction of labour significantly reduced the risk of shoulder dystocia or associated morbidity ( n = 8 ) compared with expectant management ( n = 25 ; relative risk [ RR ] 032 , 95 % CI 015-071 ; p = 0004 ) .


We recorded no brachial plexus injuries , intracranial haemorrhages , or perinatal deaths .


The likelihood of spontaneous vaginal delivery was higher in women in the induction group than in those in the expectant management group ( RR 114 , 95 % CI 101-129 ) .


Caesarean delivery and neonatal morbidity did not differ significantly between the groups .


Induction of labour for suspected large-for-date fetuses is associated with a reduced risk of shoulder dystocia and associated morbidity compared with expectant management .


Induction of labour does not increase the risk of caesarean delivery and improves the likelihood of spontaneous vaginal delivery .


These benefits should be balanced with the effects of early-term induction of labour .


Assistance Publique-Hpitaux de Paris and the University of Geneva .


Elevated concentrations of doxorubicin are found in eccrine sweat glands of the palms and soles .


We therefore evaluated an antiperspirant as preventive treatment for palmar-plantar erythrodysesthesia ( hand-foot syndrome ) in patients with metastatic breast cancer treated with pegylated liposomal doxorubicin .


An antiperspirant containing aluminum chlorohydrate or placebo cream was applied to the left or right hand and foot in a double-blinded manner ( intra-patient randomization ) .


The primary endpoint was the rate of grade 2 or 3 palmar-plantar erythrodysesthesia .


A secondary endpoint was the patient-reported symptom burden ( tingling , numbness , pain , or skin problems ) .


Using McNemar 's matched pairs design , 53 patients were needed to detect a 20 % difference between the treatment and placebo sides with a significance level of 5 % and power of 90 % .


Grade 2 or 3 PPE occurred in 30 ( 58 % ) of 52 evaluable patients ; in six patients adverse effects occurred on the placebo side but not on the treatment side , whereas one patient developed palmar-plantar erythrodysesthesia on the treatment side only ( P = 0.07 ) .


Four patients developed grade 2 or 3 palmar-plantar erythrodysesthesia on their foot on the placebo side but not on the treatment side ( P = 0.05 ) .


In the cohort with grade 2 or 3 palmar-plantar erythrodysesthesia there was a trend towards fewer dermatologic symptomatologies with the active treatment ( P = 0.05 ) , and no difference for other adverse events .


Using topical aluminum chlorohydrate as an antiperspirant appears to reduce the incidence of grade 2 or 3 palmar-plantar erythrodysesthesia following pegylated liposomal doxorubicin chemotherapy for metastatic breast cancer .


Methotrexate is the most frequently used first-line antirheumatic drug .


We report the findings of a phase 3 study of monotherapy with tofacitinib , an oral Janus kinase inhibitor , as compared with methotrexate monotherapy in patients with rheumatoid arthritis who had not previously received methotrexate or therapeutic doses of methotrexate .


We randomly assigned 958 patients to receive 5 mg or 10 mg of tofacitinib twice daily or methotrexate at a dose that was incrementally increased to 20 mg per week over 8 weeks ; 956 patients received a study drug .


The coprimary end points at month 6 were the mean change from baseline in the van der Heijde modified total Sharp score ( which ranges from 0 to 448 , with higher scores indicating greater structural joint damage ) and the proportion of patients with an American College of Rheumatology ( ACR ) 70 response ( 70 % reduction in the number of both tender and swollen joints and 70 % improvement in three of five other criteria : the patient 's assessment of pain , level of disability , C-reactive protein level or erythrocyte sedimentation rate , global assessment of disease by the patient , and global assessment of disease by the physician ) .


Mean changes in the modified total Sharp score from baseline to month 6 were significantly smaller in the tofacitinib groups than in the methotrexate group , but changes were modest in all three groups ( 0.2 points in the 5-mg tofacitinib group and < 0.1 point in the 10-mg tofacitinib group , as compared with 0.8 points in the methotrexate group [ P < 0.001 for both comparisons ] ) .


Among the patients receiving tofacitinib , 25.5 % in the 5-mg group and 37.7 % in the 10-mg group had an ACR 70 response at month 6 , as compared with 12.0 % of patients in the methotrexate group ( P < 0.001 for both comparisons ) .


Herpes zoster developed in 31 of 770 patients who received tofacitinib ( 4.0 % ) and in 2 of 186 patients who received methotrexate ( 1.1 % ) .


Confirmed cases of cancer ( including three cases of lymphoma ) developed in 5 patients who received tofacitinib and in 1 patient who received methotrexate .


Tofacitinib was associated with increases in creatinine levels and in low-density and high-density lipoprotein cholesterol levels .


In patients who had not previously received methotrexate or therapeutic doses of methotrexate , tofacitinib monotherapy was superior to methotrexate in reducing signs and symptoms of rheumatoid arthritis and inhibiting the progression of structural joint damage .


The benefits of tofacitinib need to be considered in the context of the risks of adverse events .


( Funded by Pfizer ; ORAL Start ClinicalTrials.gov number , NCT01039688 . )


Depression is common and the efficacy of antidepressants is suboptimal .


High plasma homocysteine has been consistently associated with depression , and treatment with certain B vitamins demonstrably reduces its concentration .


To determine whether vitamins B6 , B12 and folic acid enhance response to antidepressant treatment over 52 weeks .


Randomised , double-blind , placebo-controlled trial of citalopram ( 20-40 g ) together with 0.5 mg of vitamin B12 , 2 mg of folic acid and 25 mg of vitamin B6 for 52 weeks ( Australian and New Zealand Clinical Trials Registry : 12609000256279 ) .


Participants were community-dwelling adults aged 50 years or over with DSM-IV-TR major depression .


We measured severity of symptoms with the Montgomery-sberg Depression Rating Scale ( MADRS ) .


The primary outcome was remission of the depressive episode after 12 , 26 and 52 weeks .


Secondary outcomes included reduction of MADRS scores over time and relapse of major depression after recovery by week 12 .


Results In total , 153 people were randomised ( 76 placebo , 77 vitamins ) .


Remission of symptoms was achieved by 78.1 and 79.4 % of participants treated with placebo and vitamins by week 12 ( P = 0.840 ) , by 76.5 and 85.3 % at week 26 and 75.8 and 85.5 % at week 52 ( effect of intervention over 52 weeks : odds ratio ( OR ) = 2.49 , 95 % CI 1.12-5 .51 ) .


Group differences in MADRS scores over time were not significant ( P = 0.739 ) .


The risk of subsequent relapse among those who had achieved remission of symptoms at week 12 was lower in the vitamins than placebo group ( OR = 0.33 , 95 % CI 0.12-0 .94 ) .


B vitamins did not increase the 12-week efficacy of antidepressant treatment , but enhanced and sustained antidepressant response over 1 year .


Replication of these findings would mandate that treatment guidelines adopt the adjunctive use of B vitamins as a safe and inexpensive strategy to manage major depression in middle-aged and older adults .


The Veterans Administration Cooperative Studies Program # 468 , a multicenter study that randomized Parkinson 's disease ( PD ) patients to either subthalamic nucleus ( STN ) or globus pallidus internus ( GPi ) deep brain stimulation ( DBS ) , found that stimulation at either target provided similar overall motoric benefits .


We conducted an additional analysis of this data set to evaluate whether PD motor subtypes responded differently to the 2 stimulation targets .


We classified 235 subjects by motor subtype : tremor dominant ( TD ) , intermediate ( I ) , or postural instability gait difficulty ( PIGD ) , based on pre-DBS baseline Unified Parkinson 's Disease Rating Scale ( UPDRS ) scores off-medication .


The primary outcome was change in UPDRS part III ( UPDRS-III ) off-medication scores from baseline to 24 months post-DBS , compared among subjects with particular PD motor subtypes and by DBS target ( STN vs GPi ) .


Changes in tremor , rigidity , akinesia , and gait scores were also assessed using the UPDRS .


TD patients had greater mean overall motor improvement , measured by UPDRS-III , after GPi DBS , compared to STN DBS ( 17.513.0 vs 14.614.9 , p = 0.02 ) , with improvement in gait accounting for this difference .


Regardless of stimulation target , PIGD subjects had lower mean overall improvement in UPDRS-III scores compared with I or TD subjects ( 8.712.2 vs 21.711.2 vs 16.313.8 , p = 0.001 ) .


Our results suggest that responsiveness to both GPi and STN DBS is similar among different PD motor subtypes , although the TD motor subtype may have a greater response to GPi DBS with respect to gait .


PIGD patients obtained less overall benefit from stimulation .


To compare the six-month outcome of three different ultrasound-guided treatments for de Quervain 's disease ( DQD ) .


We prospectively treated 75 consecutive patients ( 51 females , 24 males , mean age standard deviation = 45.39.8 years ) with DQD .


Patients ' features ( hand dominance , intraretinaculum septum , accessory tendons ) were recorded .


Visual analogue scale ( VAS ) , reduced disability ( quickDASH ) score , and retinaculum thickness were evaluated at baseline and after one ( excluding retinaculum thickness ) , three , and six months .


Patients were randomized into three groups of 25 patients each treated under ultrasound guidance : Group A ( 1 ml methylprednisolone acetate ; mean baseline thickness = 1.6 mm ; mean baseline VAS = 6 ; mean baseline quickDASH = 55 ) ; Group B ( 1 ml methylprednisolone acetate +15 - day delayed 2 ml saline 0.9 % ; 1.4 ; 6 ; 56 ) ; Group C ( 1 ml methylprednisolone acetate +15 - day delayed 2 ml low molecular weight hyaluronic acid ; 1.7 ; 6 ; 55 ) .


After one month results were : Group A mean VAS = 2 ; mean quickDASH = 23 ; Group B 2 ; 22 ; Group C 2 ; 21 .


After three months results were : Group A retinaculum thickness = 0.7 mm ; 3 ; 27 ) ; Group B 0.8 mm ; 1 ; 25 ; Group C 0.5 mm ; 1 ; 23 .


After six months results were : Group A 1.5 mm ; 3 ; 51 ; Group B 1 mm ; 2 ; 51 ; Group C 0.7 mm ; 1 ; 26 ( P < 0.001 for all vs. baseline ) .


Patients ' age , sex , hand dominance , presence of subcompartment dividing septum , and supernumerary tendons had no influence on outcome ( P 0.177 ) .


Addition of hyaluronic acid to ultrasound-guided injections of steroids to treat DQD seems to improve the outcome and to reduce the recurrence rate .


Ultrasound guidance allows for safe injection procedures to treat de Quervains ' disease Steroid injections allow prompt recovery in de Quervain 's disease with short-term recurrence Addition of hyaluronic acid allows recurrence rate reduction compared to simple steroid injections .


Older individuals often have a reduced immune response to influenza vaccination , which might be improved by administering a higher vaccine dose .


We compared the immune response to two single doses of the AS03A-adjuvanted H5N1 pandemic vaccine ( 3.75 g hemagglutinin of A/Vietnam/1194 / 2004 ) with that of two double vaccine doses ( 7.5 g hemagglutinin ) in adults aged 61 years .


Here we report the 2-year persistence of the humoral and cellular immune response .


In this phase II , open-label study , healthy participants aged 61 to 88 years ( median 68 years ) were randomised ( 3:1:3:1 ) to receive two single doses of the AS03A-adjuvanted vaccine ( 1xH5N1-AS ) or the non-adjuvanted vaccine ( 1xH5N1 ) , or two double doses of the AS03A-adjuvanted vaccine ( 2xH5N1-AS ) or the non-adjuvanted vaccine ( 2xH5N1 ) , 21 days apart .


Serum haemagglutination inhibition antibodies and cellular immune responses against A/Vietnam/1194 / 2004 were measured in all groups at months 12 and 24 ; neutralising antibodies were assessed in a subset of the adjuvanted groups .


Serious adverse events and adverse events of specific interest were recorded .


At month 24 , haemagglutination inhibition antibody seroprotection rates were 37.2 % ( 95 % CI 27.0 % to 48.3 % ) for 1xH5N1-AS , 30.9 % ( 95 % CI 21.1 % to 42.1 % ) for 2xH5N1-AS , 16.2 % ( 95 % CI 6.2 % to 32.0 % ) for 1xH5N1 , and 8.3 % ( 95 % CI 1.0 % to 27.0 % ) for 2xH5N1 .


Haemagglutination inhibition antibody geometric mean titres were 17.6 ( 95 % CI 13.7 to 22.5 ) for 1xH5N1-AS , 18.4 ( 95 % CI 14.2 to 23.8 ) for 2xH5N1-AS , 12.3 ( 95 % CI 8.9 to 16.9 ) for 1xH5N1 and 9.8 ( 95 % CI 6.7 to 14.4 ) for 2xH5N1 .


The median frequency of antigen-specific CD4 + T cells per 106 T cells ( 25th quartile ; 75th quartile ) was 852 ( 482 ; 1477 ) for 1xH5N1-AS , 1147 ( 662 ; 1698 ) for 2xH5N1-AS , 556 ( 343 ; 749 ) for 1x-H5N1 and 673 ( 465 ; 1497 ) for 2xH5N1 .


Neutralising antibody geometric mean titres were 391.0 ( 95 % CI 295.5 to 517.5 ) in the 1xH5N1-AS group and 382.8 ( 95 % CI 317.4 to 461.6 ) in the 2xH5N1-AS group .


Antibody levels declined substantially in all groups .


Seroprotection rates , geometric mean titres for haemagglutination inhibition antibodies , and CD4 + T-cell responses tended to be higher in the AS03A-adjuvanted groups .


There was no clear benefit , in terms of long-term persistence of the immune response , of doubling the dose of the adjuvanted vaccine .


No safety concern was observed up to 24 months post-primary vaccination .


NCT00397215 ( 7 November 2006 ) .


School-based mass treatment with praziquantel is the cornerstone for schistosomiasis control in school-aged children .


However , uptake of treatment among school-age children in Uganda is low in some areas .


The objective of the study was to examine the effectiveness of a pre-treatment snack on uptake of mass treatment .


In a cluster randomized trial carried out in Jinja district , Uganda , 12 primary schools were randomized into two groups ; one received education messages for schistosomiasis prevention for two months prior to mass treatment , while the other , in addition to the education messages , received a pre-treatment snack shortly before mass treatment .


Four weeks after mass treatment , uptake of praziquantel was assessed among a random sample of 595 children in the snack schools and 689 children in the non-snack schools as the primary outcome .


The occurrence of side effects and the prevalence and mean intensity of Schistosoma mansoni infection were determined as the secondary outcomes .


Uptake of praziquantel was higher in the snack schools , 93.9 % ( 95 % CI 91.7 % -95.7 % ) , compared to that in the non-snack schools , 78.7 % ( 95 % CI 75.4 % -81.7 % ) ( p = 0.002 ) .


The occurrence of side effects was lower in the snack schools , 34.4 % ( 95 % CI 31.5 % -39.8 % ) , compared to that in the non-snack schools , 46.9 % ( 95 % CI 42.2 % -50.7 % ) ( p = 0.041 ) .


Prevalence and mean intensity of S. mansoni infection was lower in the snack schools , 1.3 % ( 95 % CI 0.6 % -2.6 % ) and 38.3 eggs per gram of stool ( epg ) ( 95 % CI 21.8-67 .2 ) , compared to that in the non-snack schools , 14.1 % ( 95 % CI 11.6 % -16.9 % ) ( p = 0.001 ) and 78.4 epg ( 95 % CI 60.6-101 .5 ) ( p = 0.001 ) , respectively .


Our results suggest that provision of a pre-treatment snack combined with education messages achieves a higher uptake compared to the education messages alone .


The use a pre-treatment snack was associated with reduced side effects as well as decreased prevalence and intensity of S. mansoni infection .


www.ClinicalTrials.gov NCT01869465


The tradeoff between stent thrombosis ( ST ) and major bleeding ( MB ) of 12 - versus 6-month dual antiplatelet therapy ( DAPT ) after coronary stent implantation has not been clearly defined .


Definite/probable ST and MB ( TIMI major and Bleeding Academic Research Consortium ( BARC ) 3 ) were compared in 2 subsequent trials with similar inclusion criteria but different DAPT duration , that is , BASKET ( 6 months ; n = 557 ) and BASKET-PROVE ( 12 months ; n = 2,314 ) , between months 0 to 6 ( DAPT in both trials ) , 7 to 12 ( DAPT in BASKET-PROVE only ) , and 13 to 24 ( aspirin in both trials ) using propensity score-adjusted , time-stratified Cox proportional hazard models .


Overall , event rates were low with fewer ST but similar MB in prolonged DAPT .


Analysis of the 3 periods showed a uniform pattern for ST ( interaction DAPT/period ; P = .145 ) but an inconsistent pattern for MB ( interaction DAPT/period ; P < .001 for TIMI major and P = .046 for BARC 3 ) , with more MB occurring during months 7 to 12 with prolonged DAPT .


Considering observed case fatality rates of 31 % with ST and 11 % with MB , the extrapolated prevention of 27 ST deaths and the excess of 5 MB deaths resulted in an expected benefit of 22 survivors/10 ,000 patients treated over 2 years with prolonged DAPT .


Despite overall low event rates , prolonged DAPT was associated with more MB during months 7 to 12 according to the interaction DAPT/period .


Given the higher observed case fatality rates of ST versus MB , 12 - versus 6-month DAPT was associated with an extrapolated reduction in mortality .


Effective treatment periods and case fatality rates seem important in the analysis of different DAPT durations , specifically with regard to ongoing trials .


To identify risk factors for port infections within 30 days of placement .


A retrospective chart review of port placements from 2002-2009 was conducted .


Patients who had port removals secondary to infection within the first 30 days of placement were included .


This group of patients was compared with a control group of patients with ports with no evidence of infection .


For every one patient with a port infection , two control subjects were chosen of the same gender and new port placement during the same month as the corresponding patient with an infected port .


From 2002-2009 , 4,404 ports were placed .


Of the 4,404 patients , 33 ( 0.7 % ) were found to have a port infection within 30 days of placement .


Compared with the control group , the early infection group had a higher prevalence of leukopenia ( 21.2 % vs 6.1 % , P = .039 ) and thrombocytopenia ( 33 % vs 12 % , P = .0158 ) .


There was also a higher prevalence of an inpatient hospital stay during port placement and high international normalized ratio in the early infection group .


Low preoperative white blood cell and platelet counts were risk factors for early infection .


Abnormal coagulation profiles and inpatient access of ports after placement could be additional risk factors .


Quality of life ( QOL ) can be considered as a quality indicator of health care systems and nurses can play an important role to improve QOL in patients with congestive heart failure ( CHF ) .


The aim of this study was to determine the effects of education provided by nurses on the QOL in patients with CHF in home-visit care compared to usual care .


In a single-blind randomized controlled trial conducted from September 2011 to June 2012 , 110 patients with CHF were randomly assigned into two groups .


While patients in group I were received usual education at the time of hospital discharge , patients in Group II , in addition to usual education , were received special education regards to their illness by nurses who visited patients in their homes .


The 36-item short-form ( SF-36 ) questionnaire was used to evaluate the patient 's QOL at the time of discharge and also six months after hospital discharge .


At the time of hospital discharge , mean score of all 8 sub-score of SF-36 questionnaire was 63.47.8 in patients of group II and 61.16.4 in patients of group I , respectively ( P > 0.05 ) .


QOL was decreased in group I and increased in group II compared to the time of hospital discharge .


After six months , mean score of QOL was higher in group II than in group I.


QOL of patients with CHF were decreased after hospital discharge .


Education provided by nurses in home-visit care could improve the QOL in patients with CHF , based on the findings of this study .


Short message service ( SMS ) has been suggested as an effective method to improve adherence to medical therapy in some chronic diseases .


However , data on the effects of SMS interventions to allergic rhinitis ( AR ) treatment is limited at present .


We aimed to assess whether a daily SMS reminder could improve AR patients ' adherence to medication and treatment outcomes .


Fifty outpatients with AR were randomized to either receive ( SMS group ) or not ( control group ) a daily SMS reminder on their cell phone to take intranasal corticosteroid treatment for 30 days .


The primary study outcomes were self-reported adherence to medication , clinic attendance rate , and severity of AR symptoms using a visual analogue scale ( VAS ) .


Secondary outcomes were changes in nasal patency ( minimum cross-sectional area , nasal cavity volume , and nasal airway resistance ) and exhaled nasal nitric oxide levels .


Self-reported adherence to medication in the SMS group ( 15/25 , 60 % ) , was significantly higher than in the control group ( 7/25 , 28 % , p = 0.02 ) .


Similarly , the clinic attendance rate in the SMS group ( 72 % ) was significantly higher than in the control group ( 40 % , p = 0.02 ) .


Although the VAS score improved significantly from baseline in both study groups , the improvement in the SMS group was significantly greater than in the control group ( 4.38 4.38 vs. 8.74 6.54 , p = 0.031 ) .


No significant differences were observed between the two groups for the secondary outcomes .


A daily SMS reminder may be an effective intervention to improve adherence to medication and treatment outcomes in AR patients .


The American Academy of Pediatrics recommends a permissive hypoxaemic target for an oxygen saturation of 90 % for children with bronchiolitis , which is consistent with the WHO recommendations for targets in children with lower respiratory tract infections .


No evidence exists to support this threshold .


We aimed to assess whether the 90 % or higher target for management of oxygen supplementation was equivalent to a normoxic 94 % or higher target for infants admitted to hospital with viral bronchiolitis .


We did a parallel-group , randomised , controlled , equivalence trial of infants aged 6 weeks to 12 months of age with physician-diagnosed bronchiolitis newly admitted into eight paediatric hospital units in the UK ( the Bronchiolitis of Infancy Discharge Study [ BIDS ] ) .


A central computer randomly allocated ( 1:1 ) infants , in varying length blocks of four and six and without stratification , to be clipped to standard oximeters ( patients treated with oxygen if pulse oxygen saturation [ SpO2 ] < 94 % ) or modified oximeters ( displayed a measured value of 90 % as 94 % , therefore oxygen not given until SpO2 < 90 % ) .


All parents , clinical staff , and outcome assessors were masked to allocation .


The primary outcome was time to resolution of cough ( prespecified equivalence limits of plus or minus 2 days ) in the intention-to-treat population .


This trial is registered with ISRCTN , number ISRCTN28405428 .


Between Oct 3 , and March 30 , 2012 , and Oct 1 , and March 29 , 2013 , we randomly assigned 308 infants to standard oximeters and 307 infants to modified oximeters .


Cough resolved by 150 days ( median ) in both groups ( 95 % CI for difference -1 to 2 ) and so oxygen thresholds were equivalent .


We recorded 35 serious adverse events in 32 infants in the standard care group and 25 serious adverse events in 24 infants in the modified care group .


In the standard care group , eight infants transferred to a high-dependency unit , 23 were readmitted , and one had a prolonged hospital stay .


In the modified care group , 12 infants were transferred to a high-dependency unit and 12 were readmitted to hospital .


Recorded adverse events did not differ significantly .


Management of infants with bronchiolitis to an oxygen saturation target of 90 % or higher is as safe and clinically effective as one of 94 % or higher .


Future research should assess the benefits and risks of different oxygen saturation targets in acute respiratory infection in older children , particularly in developing nations where resources are scarce .


National Institute for Health Research , Health Technology Assessment programme .


Chronic periodontitis , a destructive inflammatory disorder of the supporting structures of the teeth , is prevalent in patients with diabetes .


Limited evidence suggests that periodontal therapy may improve glycemic control .


To determine if nonsurgical periodontal treatment reduces levels of glycated hemoglobin ( HbA1c ) in persons with type 2 diabetes and moderate to advanced chronic periodontitis .


The Diabetes and Periodontal Therapy Trial ( DPTT ) , a 6-month , single-masked , multicenter , randomized clinical trial .


Participants had type 2 diabetes , were taking stable doses of medications , had HbA1c levels between 7 % and less than 9 % , and untreated chronic periodontitis .


Five hundred fourteen participants were enrolled between November 2009 and March 2012 from diabetes and dental clinics and communities affiliated with 5 academic medical centers .


The treatment group ( n = 257 ) received scaling and root planing plus chlorhexidine oral rinse at baseline and supportive periodontal therapy at 3 and 6 months .


The control group ( n = 257 ) received no treatment for 6 months .


Difference in change in HbA1c level from baseline between groups at 6 months .


Secondary outcomes included changes in probing pocket depths , clinical attachment loss , bleeding on probing , gingival index , fasting glucose level , and Homeostasis Model Assessment ( HOMA2 ) score .


Enrollment was stopped early because of futility .


At 6 months , mean HbA1c levels in the periodontal therapy group increased 0.17 % ( SD , 1.0 ) , compared with 0.11 % ( SD , 1.0 ) in the control group , with no significant difference between groups based on a linear regression model adjusting for clinical site ( mean difference , -0.05 % [ 95 % CI , -0.23 % to 0.12 % ] ; P = .55 ) .


Periodontal measures improved in the treatment group compared with the control group at 6 months , with adjusted between-group differences of 0.28 mm ( 95 % CI , 0.18 to 0.37 ) for probing depth , 0.25 mm ( 95 % CI , 0.14 to 0.36 ) for clinical attachment loss , 13.1 % ( 95 % CI , 8.1 % to 18.1 % ) for bleeding on probing , and 0.27 ( 95 % CI , 0.17 to 0.37 ) for gingival index ( P < .001 for all ) .


Nonsurgical periodontal therapy did not improve glycemic control in patients with type 2 diabetes and moderate to advanced chronic periodontitis .


These findings do not support the use of nonsurgical periodontal treatment in patients with diabetes for the purpose of lowering levels of HbA1c .


clinicaltrials.gov Identifier : NCT00997178 .


To evaluate the sustaining effects of Tai chi Qigong in improving the physiological health for COPD patients at sixth month .


A randomized controlled trial .


Subjects were in three randomly assigned groups : Tai chi Qigong group , exercise group , and control group .


The 206 subjects were recruited from five general outpatient clinics .


Tai chi Qigong group completed a 3-month Tai chi Qigong program .


Exercise group practiced breathing and walking as an exercise .


Control group received usual care .


Primary outcomes included six-minute walking distance and lung functions .


Secondary outcomes were dyspnea and fatigue levels , number of exacerbations and hospital admissions .


Tai chi Qigong group showed a steady improvement in exercise capacity ( P < .001 ) from baseline to the sixth month .


The mean walking distance increased from 298 to 349 meters ( +17 % ) .


No significant changes were noted in the other two groups .


Tai chi Qigong group also showed improvement in lung functions ( P < .001 ) .


Mean forced expiratory volume in 1s increased from .89 to .99 l ( +11 % ) .


No significant change was noted in the exercise group .


Deterioration was found in the control group , with mean volume decreased from .89 to .84 l ( -5.67 % ) .


Significant decreased in the number of exacerbations was observed in the Tai chi Qigong group .


No changes in dyspnea and fatigue levels were noted among the three groups .


Tai chi Qigong has sustaining effects in improving the physiological health and is a useful and appropriate exercise for COPD patients .


During maneuvering , fighter pilots experience loads of up to 50-70 kg on their necks .


Neck disorders are common and have been linked to impairment in muscle control .


We conducted an intervention study introducing targeted training for 24 wk that reduced neck pain .


The current study reports the results of the secondary objective , which was to increase the understanding of possible mechanisms underlying such neck pain and its intervention-related relief .


In a parallel , single-blinded , randomized controlled study , 55 F-16 pilots were evaluated at baseline and randomized to a control group ( CG ; N = 28 ) or training group ( TG ; N = 27 ) .


Postural control was tested in four different settings : Romberg with open and closed eyes , unilateral stance , and perturbation .


Maximal voluntary contraction and force steadiness was measured for shoulder elevation .


At follow-up , there was a significant between-group difference in the Romberg test with closed eyes only ( 95 % confidence ellipse area ; CG : 761 + / - 311 mm2 ; TG : 650 + / - 405 mm2 ) .


Prior to randomization , there were no significant differences in postural control and steadiness between 30 pilots who experienced neck pain within the previous 3 mo and 25 pilots without such pain .


Impaired postural control and steadiness may only be quantifiable in individuals experiencing acute neck pain of certain intensity , and there may be a ceiling effect in the ability to improve these parameters .


For individuals with highly developed physiological capacity , a battery of tests with more stringent demands should be considered , e.g. , increased number of repetitions , prolonged duration of the tests , or testing with eyes closed .


The aim of this study was to assess the degree of fluctuation of osteitis on MRI during long-term treatment with etanercept ( ETN ) in patients with early axial SpA ( axSpA ) with active inflammation ( osteitis ) on whole-body MRI in the spine and/or the SI joints at baseline .


We analysed MRI data from 328 SI joint quadrants and 943 spine vertebral units ( VUs ) in terms of osteitis in the pooled data set of 41 patients who were treated with ETN for 3 consecutive years .


Scoring was performed by two blinded radiologists at baseline , year 2 and year 3 .


Through years 2 and 3 , osteitis on MRI resolved completely in 56 of 144 ( 38.9 % ) SI joint quadrants and in 20 of 40 ( 50 % ) VUs affected at baseline , while persistent osteitis was found in 24 of 144 ( 16.7 % ) SI joint quadrants and in 8 of 40 ( 20.0 % ) spine VUs .


The development of new osteitis in sites that were free of osteitis at baseline only occurred in 2 of 131 ( 1.5 % ) SI joint quadrants and in 3 of 862 ( 0.4 % ) spine VUs in both year 2 and year 3 .


There was a consistently small amount of osteitis on MRI in patients with early axSpA compared with baseline values , and only a very low rate of new-onset osteitis was found during 3 years of continuous treatment with ETN .


www.clinicaltrials.gov , NCT00844142 .


Current tobacco use treatment approaches require smokers to request treatment or depend on the provider to initiate smoking cessation care and are therefore reactive .


Most smokers do not receive evidence-based treatments for tobacco use that include both behavioral counseling and pharmacotherapy .


To assess the effect of a proactive , population-based tobacco cessation care model on use of evidence-based tobacco cessation treatments and on population-level smoking cessation rates ( ie , abstinence among all smokers including those who use and do not use treatment ) compared with usual care among a diverse population of current smokers .


The Veterans Victory Over Tobacco Study , a pragmatic randomized clinical trial involving a population-based registry of current smokers aged 18 to 80 years .


A total of 6400 current smokers , identified using the Department of Veterans Affairs ( VA ) electronic medical record , were randomized prior to contact to evaluate both the reach and effectiveness of the proactive care intervention .


Current smokers were randomized to usual care or proactive care .


Proactive care combined ( 1 ) proactive outreach and ( 2 ) offer of choice of smoking cessation services ( telephone or in-person ) .


Proactive outreach included mailed invitations followed by telephone outreach to motivate smokers to seek treatment with choice of services .


The primary outcome was 6-month prolonged smoking abstinence at 1 year and was assessed by a follow-up survey among all current smokers regardless of interest in quitting or treatment utilization .


A total of 5123 participants were included in the primary analysis .


The follow-up survey response rate was 66 % .


The population-level , 6-month prolonged smoking abstinence rate at 1 year was 13.5 % for proactive care compared with 10.9 % for usual care ( P = .02 ) .


Logistic regression mixed model analysis showed a significant effect of the proactive care intervention on 6-month prolonged abstinence ( odds ratio [ OR ] , 1.27 [ 95 % CI , 1.03-1 .57 ] ) .


In analyses accounting for nonresponse using likelihood-based not-missing-at-random models , the effect of proactive care on 6-month prolonged abstinence persisted ( OR , 1.33 [ 95 % CI , 1.17-1 .51 ] ) .


Proactive , population-based tobacco cessation care using proactive outreach to connect smokers to evidence-based telephone or in-person smoking cessation services is effective for increasing long-term population-level cessation rates .


clinicaltrials.gov Identifier : NCT00608426 .


To investigate the effects of multimodal supervised exercise on physical functioning , falls , and related injuries in older women .


Two-year randomized controlled trial .


Tampere , Finland .


Women aged 70 to 80 who had fallen in the previous year ( n = 409 ) .


Participants were randomly assigned to an exercise or control group ( ClinicalTrial.gov NCT00986466 ) .


Exercisers participated in group exercise classes twice a week for 12 months and once a week for the subsequent 12 months and home exercises .


Controls maintained their current physical activity .


Physical functioning assessed at baseline and at 6-month intervals during the intervention .


Falls and related injuries monitored with fall diaries .


Intention-to-treat analyses showed that exercise led to significant improvements in physical functioning .


Leg strength differed significantly between the groups ( mean change : 14.1 % , 95 % confidence interval ( CI ) = 8.0 to 20.2 in exercisers ; 1.6 % , 95 % CI = -4.5 to 7.7 in controls ; P < .001 ) .


Chair stand time also differed significantly between groups ( 7.4 % , 95 % CI 3.8 to 10.8 % in exercisers ; 2.4 % , 95 % CI = -1.6 to 6.2 ) in controls ; P = .02 ) .


Between-group differences were significant for fast walking speed ( P = .003 ) and probability of completing the backward walking test ( P < .001 ) , favoring exercisers .


Timed Up-and-Go and grip strength did not differ between groups .


There was no difference in the total falls incidence rate ratio ( IRR = 1.0 , 95 % CI = 0.79 to 1.26 ) , but exercisers were less likely to have medically attended injurious falls ( IRR = 0.45 , 95 % CI = 0.27 to 0.78 ; P = .004 ) .


Twenty-four months of multimodal exercise enhanced physical functioning in women aged 70 to 80 with a history of falls .


Although the total number of falls was not lower than in controls , the rate of medically attended injurious falls was more than 50 % lower .


To test the strength of the association between parental monitoring trajectories throughout early adolescence ( ages 11-14 ) and gambling behaviours by young adulthood ( age 22 ) .


Longitudinal cohort design .


Baltimore , Maryland .


The sample of 514 participants with gambling data between ages 16-22 and parental monitoring data between ages 11-14 were predominantly African American and received subsidized lunches at age 6 .


The South Oaks Gambling Screen and South Oaks Gambling Screen-Revised for Adolescents collected self-reports on annual gambling and gambling problems between ages 16-22 .


The Parental Monitoring Subscale of the Structured Interview of Parent Management Skills and Practices-Youth Version collected self-reports on annual parental monitoring between ages 11-14 .


General growth mixture modelling identified two parental monitoring trajectories : ( i ) ` stable ' class ( 84.9 % ) began with a high level of parental monitoring at age 11 that remained steady to age 14 ; ( ii ) ` declining ' class ( 15.1 % ) began with a significantly lower level of parental monitoring at age 11 and experienced a significant to through age 14 .


The declining class had increased significantly unadjusted ( OR = 1.91 ; 95 % CI = 1.59 , 2.23 ; P0 .001 ) and adjusted ( aOR = 1.57 ; 95 % CI = 1.24 , 1.99 ; P = 0.01 ) odds of problem gambling compared with non-gambling .


Low and/or declining parental monitoring of children between the ages of 11 and 14 is associated significantly with problem gambling when those children reach young adulthood .


Prospective randomized controlled multicenter study .


To compare the effect of X-Stop with minimally invasive decompression ( MID ) in patients with neurogenic intermittent claudication due to lumbar spinal stenosis .


Lumbar spinal stenosis is the most common indication for operative treatment in elderly .


Laminectomy has been the `` gold standard , '' but MID is now widely used .


Another minimally invasive surgery option is X-Stop showing good result compared with nonoperative treatment , but showing higher reoperation rate than laminectomy .


We enrolled 96 patients aged 50 to 85 years , with symptoms of neurogenic intermittent claudication within 250-m walking distance and 1 - or 2-level lumbar spinal stenosis , randomized to either MID or X-Stop .


Primary outcome was Zurich Claudication Questionnaire in this intention-to-treat analysis .


Secondary outcome was Oswestry Disability Index , EuroQol 5-dimensional questionnaire , numerical rating scale 11 for lower back pain and leg pain , and risk for secondary surgery and complications .


No significant differences were found in Zurich Claudication Questionnaire between the groups at any follow-ups .


Both groups had a statistical and clinical significant improvement at 6 weeks and throughout the 2-year observation period .


The number of patients having secondary surgery due to persistent or recurrent symptoms was significantly higher in the X-Stop group , odds ratio ( 95 % confidence interval ) = 6.5 ( 1.3-31 .9 ) .


Complication rate was similar and low , but more severe for MID .


Both MID and X-Stop led to significant symptom improvements .


There were no significant clinical differences in effect between the methods at any of the follow-up time points .


X-Stop had significant higher risk of secondary surgery .


Complication was more severe for MID .


In clinical practice , nonsteroidal anti-inflammatory drugs ( NSAIDs ) are commonly discontinued after response to biologic therapy is achieved in patients with axial spondyloarthritis ( axSpA ) , but the impact of NSAID discontinuation has not been assessed in prospective controlled trials .


The aim of the SPARSE study was to evaluate the effects of the anti-tumor necrosis factor agent etanercept on NSAID intake and conventional clinical outcomes in axSpA patients .


In the double-blind , placebo-controlled period , patients with active ( mini Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) 4 ) axSpA despite optimal NSAID intake were randomized to receive etanercept 50mg or placebo once weekly for 8weeks .


All patients were advised to taper/discontinue their NSAID intake during the treatment period .


NSAID intake was self-reported by diary and Assessment of SpondyloArthritis International Society ( ASAS ) - NSAID scores calculated based on ASAS recommendations .


The primary endpoint was change from baseline to week 8 in ASAS-NSAID score ( analysis of covariance ) .


In 90 randomized patients at baseline , mean age ( standard deviation ) was 38.9 ( 11.8 ) years ; disease duration , 5.7 ( 8.1 ) years ; 59/90 ( 66 % ) were human leukocyte antigen-B27 positive ; 51/90 ( 57 % ) had radiographic sacroiliitis ; and 45/90 ( 50 % ) were magnetic resonance imaging sacroiliitis-positive .


Mean ASAS-NSAID scores were similar between etanercept and placebo groups at baseline ( 98.2 ( 39.0 ) versus 93.0 ( 23.4 ) ) , as were BASDAI ( 6.0 ( 1.7 ) versus 5.9 ( 1.5 ) ) , and Bath Ankylosing Spondylitis Functional Index ( 5.2 ( 2.1 ) versus 5.1 ( 2.2 ) ) .


Mean changes ( SE ) in ASAS-NSAID score from baseline to week 8 were -63.9 ( 6.1 ) and -36.6 ( 5.9 ) in the etanercept and placebo groups ( between-group difference , -27.3 ; P = 0.002 ) .


Significantly higher proportions of patients receiving etanercept versus placebo had an ASAS-NSAID score < 10 ( 46 % versus 17 % ; P = 0.008 ) and ASAS-NSAID score of 0 ( 41 % versus 14 % ; P = 0.013 ) at this time point .


Significantly more patients in the etanercept versus placebo group achieved BASDAI50 ( 39 % versus 18 % ; P = 0.032 ) and ASAS40 ( 44 % versus 21 % ; P = 0.028 ) at week 8 .


In patients with axSpA , etanercept was associated with clinically relevant NSAID-sparing effects in addition to significant improvements in conventional clinical outcomes .


ClinicalTrials.gov NCT01298531 .


Registered 16 February 2011 .


Antimicrobial treatment reduces the symptoms of acute otitis media ( AOM ) .


The effect of antimicrobial treatment on the duration of middle ear effusion ( MEE ) and concomitant hearing impairment is not known .


To determine whether the antimicrobial treatment of AOM reduces the duration of MEE .


This randomized , double-blind , placebo-controlled trial involved a total of 84 children with AOM between 6 months and 15 years of age .


Participants were recruited from September 14 , 1999 , to January 4 , 2000 ; October 10 , 2005 , to December 16 , 2005 ; and September 22 , 2009 , to June 4 , 2012 , from among children attending an AOM prevention trial and children visiting local outpatient clinics in Oulu , Finland .


Children were randomly allocated to receive either 40 mg/kg of amoxicillin-clavulanate or a placebo mixture per day for 7 days .


The primary outcome measure was the time to the disappearance of MEE as defined by a normal tympanogram finding ( A curve ) from both ears on 2 consecutive measurement days .


Parents performed daily tympanometry at home .


The study physician performed tympanometry and otoscopy at study entry , after 3 and 7 days , and then weekly until both ears were healthy .


The main secondary outcome measures were the time to normal otoscopy findings and the proportion of children without persistent MEE at 14 days and 2 months .


Middle ear effusion disappeared 2.0 weeks ( 13.7 days ) earlier ( P = .02 ) in the antimicrobial group ( mean time , 2.7 weeks ; 95 % CI , 1.7-3 .7 ) than in the placebo group ( 4.7 weeks ; 95 % CI , 3.6-5 .7 ) .


Normal otoscopy findings were observed 1.4 weeks sooner in the antimicrobial group than in the placebo group ( P = .02 ) .


On day 14 , 69 % of children in the antimicrobial group and 38 % in the placebo group had normal tympanometry findings ( number needed to treat , 3.2 ; 95 % CI , 2.0-10 .5 ) .


On day 60 , 2 children ( 5 % ) in the antimicrobial group and 10 children ( 24 % ) in the placebo group had persistent MEE ( P = .01 ) .


Antimicrobial treatment effectively reduced the duration of MEE and possible concomitant hearing impairment in children with AOM .


Antimicrobial treatment also reduced the risk for persistent MEE .


clinicaltrials.gov Identifier : NCT01244581 .


Although the analgesic effects of corticosteroids have been well documented , little information is available on periarticular injection ( PI ) containing corticosteroids for early postoperative pain management after total knee arthroplasty ( TKA ) .


We performed a prospective double-blind randomized trial to evaluate the efficacy and safety of an intraoperative corticosteroid PI in patients undergoing TKA .


Seventy-six consecutive female patients undergoing bilateral staged TKA were randomized to receive steroid or non-steroid PI , with 3 months separating the procedures .


The steroid group received PI with a mixture containing triamcinolone acetonide ( 40 mg ) .


The non-steroid group received the same injection mixture without corticosteroid .


During the postoperative period , nighttime pain , functional recovery [ straight leg raising ( SLR ) ability and maximal flexion ] , patient satisfaction , and complications were recorded .


Short-term postoperative clinical scores and patient satisfaction were evaluated at 6 months .


The pain level was significantly lower in the PI steroid than the non-steroid group on the night of the operation ( VAS , 1.2 vs. 2.3 ; p = 0.021 ) .


Rebound pain was observed in both groups at POD1 ( VAS , 3.2 vs. 3.8 ; p = 0.248 ) , but pain remained at a low level thereafter .


No significant differences were seen in maximal flexion , frequency of acute rescuer , clinical scores , and patient satisfaction .


The steroid group was able to perform SLR earlier than the non-steroid group ( p = 0.013 ) .


The incidence of complications was similar between the groups .


PI containing a corticosteroid provided an additional pain-relieving effect on the night of the operation .


In addition , corticosteroid PI did not increase the perioperative complications of TKA .


Our aim was to characterize articulation proficiency and differences between tumor sites before and after chemoradiotherapy for advanced head and neck cancer with the help of acoustic measures .


Our further goal was to improve objective speech measures and gain insight into muscle functioning before and after treatment .


In 34 patients with laryngeal or hypopharyngeal , nasal or nasopharyngeal , or oral or oropharyngeal cancer , we acoustically analyzed nasality , vowel space , precision , and strength of articulation in 12 speech sounds ( / a / , / i / , / u / , / p / , / s / , / z / , / 1 / , / t / , / tj / , / k / , / x / , / r / ) before treatment and 10 weeks and 1 year after treatment .