WorldWideScience

Sample records for infarction-2 danami-2 substudy

  1. System delay and timing of intervention in acute myocardial infarction (from the Danish Acute Myocardial Infarction-2 [DANAMI-2] trial)

    Nielsen, Peter Haubjerg; Terkelsen, Christian Juhl; Nielsen, Torsten Toftegård

    2011-01-01

    The interval from the first alert of the healthcare system to the initiation of reperfusion therapy (system delay) is associated with mortality in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention (pPCI). The importance of system delay...... in patients treated with fibrinolysis versus pPCI has not been assessed. We obtained data on system delay from the Danish Acute Myocardial Infarction-2 study, which randomized 1,572 patients to fibrinolysis or pPCI. The study end points were 30-day and 8-year mortality. The short system delays were associated...... with reduced absolute mortality in both the fibrinolysis group (3 hours, 11.5%; test for trend, p = 0.08) and pPCI group (3 hours, 7.7%; test for trend, p = 0.02). The lowest 30-day mortality was obtained with pPCI and a system delay of 1 to 2 hours (vs fibrinolysis within 3 hours was associated with a similar...

  2. Pre-discharge exercise test for evaluation of patients with complete or incomplete revascularization following primary percutaneous coronary intervention: a DANAMI-2 sub-study

    Valeur, N.; Clemmensen, P.; Grande, P.

    2008-01-01

    revascularization had lower exercise capacity [6.5 (95% CI: 1.9-12.8) vs. 7.0 (95% CI: 2.1-14.0) METs, p = 0.004] and more frequently ST depression [43 (20%) vs. 39 (13%), p = 0.02] compared to patients with complete revascularization. ST depression was not predictive of outcome in either groups, while...... with complete revascularization. CONCLUSIONS: Exercise capacity was prognostic of reinfarction and/or death in patients with incomplete revascularization, but not in completely revascularized patients. ST segment depression alone did not predict residual coronary stenosis or dismal prognosis Udgivelsesdato......OBJECTIVES: It is unclear whether the completeness of revascularization impacts on the prognostic value of an exercise test after primary percutaneous coronary intervention (PCI). METHODS: The DANAMI-2 trial included patients with ST elevation acute myocardial infarction randomized to primary PCI...

  3. Long-term outcome of primary angioplasty compared with fibrinolysis across age groups: a Danish Multicenter Randomized Study on Fibrinolytic Therapy Versus Acute Coronary Angioplasty in Acute Myocardial Infarction (DANAMI-2) substudy

    Fosbøl, Emil Loldrup; Thune, Jens Jakob; Kelbaek, Henning

    2008-01-01

    of angioplasty versus fibrinolysis was investigated in 1,572 patients from the DANAMI-2 study across age groups. End points were total mortality and a composite end point of death, reinfarction, or disabling stroke. Follow-up was 3 years. RESULTS: Increasing age was associated with mortality (adjusted hazard...... ratio [HR] 2.45 per 10 year increment, 95% confidence interval [CI] 1.78-3.37, P age: patients aged ... 0.73, CI 0.41-1.31); 56 to 65 years (HR 0.83, CI 0.52-1.33); 66 to 75 years (HR 0.71, CI 0.48-1.04); and >75 years (HR 0.83, CI 0.59-1.17) (P = .006 for overall treatment effect and P = .5 for interaction between age and treatment). There was no long-term effect of angioplasty versus fibrinolysis...

  4. Timing of ischemic onset estimated from the electrocardiogram is better than historical timing for predicting outcome after reperfusion therapy for acute anterior myocardial infarction: a DANish trial in Acute Myocardial Infarction 2 (DANAMI-2) substudy

    Sejersten, Maria; Ripa, Rasmus S; Grande, Peer

    2007-01-01

    BACKGROUND: Acute treatment strategy and subsequently prognosis are influenced by the duration of ischemia in patients with ST-elevation acute myocardial infarction (AMI). However, timing of ischemia may be difficult to access by patient history (historical timing) alone. We hypothesized that an ......BACKGROUND: Acute treatment strategy and subsequently prognosis are influenced by the duration of ischemia in patients with ST-elevation acute myocardial infarction (AMI). However, timing of ischemia may be difficult to access by patient history (historical timing) alone. We hypothesized...

  5. Incidence, predictors, and procedural results of upgrade to resynchronization therapy: the RAFT upgrade substudy.

    Essebag, Vidal; Joza, Jacqueline; Birnie, David H; Sapp, John L; Sterns, Laurence D; Philippon, Francois; Yee, Raymond; Crystal, Eugene; Kus, Teresa; Rinne, Claus; Healey, Jeffrey S; Sami, Magdi; Thibault, Bernard; Exner, Derek V; Coutu, Benoit; Simpson, Chris S; Wulffhart, Zaev; Yetisir, Elizabeth; Wells, George; Tang, Anthony S L

    2015-02-01

    The resynchronization-defibrillation for ambulatory heart failure trial (RAFT) study demonstrated that adding cardiac resynchronization therapy (CRT) in selected patients requiring de novo implantable cardiac defibrillators (ICD) reduced mortality as compared with ICD therapy alone, despite an increase in procedure-related adverse events. Data are lacking regarding the management of patients with ICD therapy who develop an indication for CRT upgrade. Participating RAFT centers provided data regarding de novo CRT-D (CRT with ICD) implant, upgrade to CRT-D during RAFT (study upgrade), and upgrade within 6 months after presentation of study results (substudy). Substudy centers enrolled 1346 (74.9%) patients in RAFT, including 644 de novo, 80 study upgrade, and 60 substudy CRT attempts. The success rate (initial plus repeat attempts) was 95.2% for de novo versus 96.3% for study upgrade and 90.0% for substudy CRT attempts (P=0.402). Acute complications occurred among 26.2% of de novo versus 18.8% of study upgrade and 3.4% of substudy CRT implantation attempts (PRAFT study and other trials. © 2014 American Heart Association, Inc.

  6. Ectopic fat accumulation in patients with COPD: an ECLIPSE substudy

    Martin M

    2017-01-01

    Full Text Available Mickaël Martin,1 Natalie Almeras,1 Jean-Pierre Després,1 Harvey O Coxson,2 George R Washko,3 Isabelle Vivodtzev,4 Emiel FM Wouters,5 Erica Rutten,6 Michelle C Williams,7 John T Murchison,8 William MacNee,7 Don D Sin,2 François Maltais1 On behalf of the Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE Study Group 1Research Centre, Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval, Québec, QC, 2Department of Radiology, University of British Columbia, Vancouver, BC, Canada; 3Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA; 4Hypoxia Pathophysiology Laboratory, Grenoble University Hospital, Grenoble, France; 5Department of Respiratory Medicine, Maastricht University Medical Center, Maastricht, 6Research and Development, CIRO, Horn, the Netherlands; 7Department of Respiratory Medicine, University of Edinburgh, 8Department of Radiology, Royal Infirmary of Edinburgh, Edinburgh, UK Background: Obesity is increasingly associated with COPD, but little is known about the prevalence of ectopic fat accumulation in COPD and whether this can possibly be associated with poor clinical outcomes and comorbidities. The Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE substudy tested the hypothesis that COPD is associated with increased ectopic fat accumulation and that this would be associated with COPD-related outcomes and comorbidities.Methods: Computed tomography (CT images of the thorax obtained in ECLIPSE were used to quantify ectopic fat accumulation at L2–L3 (eg, cross-sectional area [CSA] of visceral adipose tissue [VAT] and muscle tissue [MT] attenuation, a reflection of muscle fat infiltration and CSA of MT. A dose–response relationship between CSA of VAT, MT attenuation and CSA of MT and COPD-related outcomes (6-minute walking distance [6MWD], exacerbation rate, quality of life, and forced

  7. Endocrine and haemodynamic changes in resistant hypertension, and blood pressure responses to spironolactone or amiloride: the PATHWAY-2 mechanisms substudies.

    Williams, Bryan; MacDonald, Thomas M; Morant, Steve V; Webb, David J; Sever, Peter; McInnes, Gordon T; Ford, Ian; Cruickshank, J Kennedy; Caulfield, Mark J; Padmanabhan, Sandosh; Mackenzie, Isla S; Salsbury, Jackie; Brown, Morris J

    2018-04-11

    In the PATHWAY-2 study of resistant hypertension, spironolactone reduced blood pressure substantially more than conventional antihypertensive drugs. We did three substudies to assess the mechanisms underlying this superiority and the pathogenesis of resistant hypertension. PATHWAY-2 was a randomised, double-blind crossover trial done at 14 UK primary and secondary care sites in 314 patients with resistant hypertension. Patients were given 12 weeks of once daily treatment with each of placebo, spironolactone 25-50 mg, bisoprolol 5-10 mg, and doxazosin 4-8 mg and the change in home systolic blood pressure was assessed as the primary outcome. In our three substudies, we assessed plasma aldosterone, renin, and aldosterone-to-renin ratio (ARR) as predictors of home systolic blood pressure, and estimated prevalence of primary aldosteronism (substudy 1); assessed the effects of each drug in terms of thoracic fluid index, cardiac index, stroke index, and systemic vascular resistance at seven sites with haemodynamic monitoring facilities (substudy 2); and assessed the effect of amiloride 10-20 mg once daily on clinic systolic blood pressure during an optional 6-12 week open-label runout phase (substudy 3). The PATHWAY-2 trial is registered with EudraCT, number 2008-007149-30, and ClinicalTrials.gov, number NCT02369081. Of the 314 patients in PATHWAY-2, 269 participated in one or more of the three substudies: 126 in substudy 1, 226 in substudy 2, and 146 in substudy 3. Home systolic blood pressure reduction by spironolactone was predicted by ARR (r 2 =0·13, p<0·0001) and plasma renin (r 2 =0·11, p=0·00024). 42 patients had low renin concentrations (predefined as the lowest tertile of plasma renin), of which 31 had a plasma aldosterone concentration greater than the mean value for all 126 patients (250 pmol/L). Thus, 31 (25% [95% CI 17-33]) of 126 patients were deemed to have inappropriately high aldosterone concentrations. Thoracic fluid content was reduced by 6·8% from

  8. Personality and Total Health Through Life Project Eye Substudy: Methodology and Baseline Retinal Features.

    Wijngaarden, Peter Van; Keel, Stuart; Hodgson, Lauren A B; Kumar, Dinesh K; Aliahmad, Behzad; Paim, Cistiane C; Kiely, Kim M; Cherbuin, Nicolas; Anstey, Kaarin J; Dirani, Mohamed

    2017-01-01

    To describe the methodology and present the retinal grading findings of an older sample of australians with well-defined indices of neurocognitive function in the Personality and total Health (PATH) through life project. A cross-sectional study. Three hundred twenty-six individuals from the PatH through life project were invited to participate. Participants completed a general questionnaire and 2-field, 45-degree nonmydriatic color digital retinal photography. Photographs were graded for retinal pathology according to established protocols. Two hundred fifty-four (77.9%) subjects, aged 72 to 78 years, agreed to participate in the eye substudy. gradable images of at least 1 eye were acquired in 211 of 254 subjects (83.1%). retinal photographic screening identified 1 or more signs of pathology in 130 of the 174 subjects (74.7%) with gradable images of both eyes. a total of 45 participants (17.7%) had self-reported diabetes and diabetic retinopathy was observed in 22 (48.9%) of these participants. This well-defined sample of older australians provides a unique opportunity to interrogate associations between retinal findings, including retinal vascular geometric parameters, and indices of neurocognitive function. Copyright 2017 Asia-Pacific Academy of Ophthalmology.

  9. Ambulatory blood pressure monitoring after 1 year on valsartan or amlodipine-based treatment: a VALUE substudy

    Pedersen, Ole Lederballe; Mancia, Giuseppe; Pickering, Thomas

    2007-01-01

    OBJECTIVE: The ambulatory blood pressure (ABP) monitoring substudy of the Valsartan Antihypertensive Long-term Use Evaluation (VALUE) trial was carried out in a subset of patients from USA, Italy and Denmark. ABP was measured after 1 year in the trial, with the aim of evaluating comparability...... of ABP levels on valsartan (VAL) and amlodipine (AML)-based regimens. METHODS: ABP was measured every 20 min during a 25-h period after morning administration of medicine; 659 patients were available for intention-to-treat analysis. RESULTS: Office blood pressure (BP) differences were smaller than...

  10. Clinical trials update from the Heart Failure Society of America Meeting 2009: FAST, IMPROVE-HF, COACH galectin-3 substudy, HF-ACTION nuclear substudy, DAD-HF, and MARVEL-1.

    Lainscak, Mitja; Coletta, Alison P; Sherwi, Nasser; Cleland, John G F

    2010-02-01

    This article presents findings and a commentary on late-breaking trials presented during the meeting of the Heart Failure Society of America in September 2009. Unpublished reports should be considered as preliminary, since analyses may change in the final publication. The FAST trial showed somewhat better performance of intrathoracic impedance for prediction of deterioration in patients with heart failure (HF) when compared with daily weighing. The IMPROVE-HF study reported the benefits of education on the management of patients with systolic HF. Galectin-3 appeared a useful method for improving risk stratification of patients with chronic HF in a substudy of the COACH trial. A nuclear substudy of the HF-ACTION trial failed to demonstrate that resting myocardial perfusion imaging, a measure of myocardial scar and viability, was clinically useful. A small randomized controlled trial (DAD-HF) suggested that the use of low-dose dopamine in patients with acutely decompensated HF was associated with less deterioration in renal function and less hypokalaemia. The MARVEL-1 trial raises further concerns about the safety of myoblast transplantation in ischaemic HF.

  11. European multicentre double-blind placebo-controlled trial of Nilvadipine in mild-to-moderate Alzheimer's disease-the substudy protocols: NILVAD frailty; NILVAD blood and genetic biomarkers; NILVAD cerebrospinal fluid biomarkers; NILVAD cerebral blood flow.

    Meulenbroek, Olga; O'Dwyer, Sarah; de Jong, Daan; van Spijker, Gerrita; Kennelly, Sean; Cregg, Fiona; Olde Rikkert, Marcel; Abdullah, Laila; Wallin, Anders; Walsh, Cathal; Coen, Robert; Kenny, Rose Anne; Daly, Leslie; Segurado, Ricardo; Borjesson-Hanson, Anne; Crawford, Fiona; Mullan, Michael; Lucca, Ugo; Banzi, Rita; Pasquier, Florence; Breuilh, Laetitia; Riepe, Matthias; Kalman, Janos; Molloy, William; Tsolaki, Magda; Howard, Robert; Adams, Jessica; Gaynor, Siobhan; Lawlor, Brian

    2016-07-19

    In conjunction with the NILVAD trial, a European Multicentre Double-Blind Placebo Controlled trial of Nilvadipine in Mild-to-Moderate Alzheimer's disease (AD), there are four NILVAD substudies in which eligible NILVAD patients are also invited to participate. The main NILVAD protocol was previously published in BMJ Open (2014). The objectives of the NILVAD substudies are to determine whether frailty, cerebrospinal fluid (CSF), blood biomarker profile and Apolipoprotein E (APOE) status predict response to Nilvadipine, and to investigate the effect of Nilvadipine on cerebral blood flow and blood biomarkers. All participants who fulfil criteria for the main NILVAD study are eligible for participation in the NILVAD substudies. Participation is subject to informed consent and whether the substudy is available at a particular NILVAD study site. Each substudy entails extra measurements during the course of the main NILVAD study. For example, in the blood and genetic biomarkers substudy, extra blood (30 mL) will be collected at week 0, week 13, week 52 and week 78, while in the cerebral blood flow substudy, participants will receive an MRI and transcranial Doppler measurements at week 0, week 26 and week 78. In the CSF substudy, 10 mL CSF is collected at week 0 and week 78. All NILVAD substudies and all subsequent amendments have received ethical approval within each participating country, according to national regulations. Each participant provides written consent to participate. All participants remain anonymised throughout and the results of each substudy will be published in an international peer reviewed journal. EUDRACT 2012-002764-27; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  12. Pressure ulcers in critically ill patients - Preventable by non-sedation? A substudy of the NONSEDA-trial.

    Nedergaard, Helene K; Haberlandt, Trine; Toft, Palle; Jensen, Hanne Irene

    2018-02-01

    Pressure ulcers still pose a significant clinical challenge to critically ill patients. This study is a substudy of the multicenter NONSEDA-trial, where critically ill patients were randomised to sedation or non-sedation during mechanical ventilation. The objective of this substudy was to assess if non-sedation affected the occurrence of pressure ulcers. Retrospective assessment of data from a single NONSEDA-trial site. Mixed intensive care unit. The occurrence of pressure ulcers, described by grade and location. 205 patients were included. Patients with pressure ulcers in the two groups were comparable with regards to baseline data. There were 44 ulcers in 32 patients in the sedated group and 31 ulcers in 25 patients in the non-sedated group (p=0.08). 64% of the ulcers in sedated patients were located on sacrum and heels, whereas 68% of the ulcers in non-sedated patients were related to equipment (p=0.03). Non-sedation did not significantly reduce the number of pressure ulcers. Non-sedation significantly affected the location of ulcers: non-sedated patients mainly had ulcers related to equipment, whereas sedated patients mainly had ulcers on the sacrum and heels. Copyright © 2017 Elsevier Ltd. All rights reserved.

  13. Hip dysplasia and osteoarthrosis: a survey of 4151 subjects from the Osteoarthrosis Substudy of the Copenhagen City Heart Study

    Jacobsen, Steffen; Sonne-Holm, Stig; Søballe, K

    2005-01-01

    Acta Orthop. 2005 Apr;76(2):149-58. Related Articles, Links Hip dysplasia and osteoarthrosis: a survey of 4151 subjects from the Osteoarthrosis Substudy of the Copenhagen City Heart Study. Jacobsen S, Sonne-Holm S, Soballe K, Gebuhr P, Lund B. Department of Orthopaedic Surgery, Copenhagen...... University Hospital, Rigshospitalet, Denmark. sjac@dadlnet.dk INTRODUCTION: Hip dysplasia (HD) is assumed to be an etiological factor in the development of premature hip osteoarthrosis (OA). We established the prevalences of HD and OA in adults according to qualified radiographic discriminators.......6 degrees). Applying a CE cut-off value of 20 degrees for designation of definite hip dysplasia, we found a prevalence of hip dysplasia of 3.4%. Approximately 2% of cases were unilateral and 1.4% of cases were bilateral. We found significant relationships between radiographic OA discriminators and the CE...

  14. The FLASSH study: protocol for a randomised controlled trial evaluating falls prevention after stroke and two sub-studies

    Mackintosh Shylie F

    2009-03-01

    Full Text Available Abstract Background Falls are common in stroke survivors returning home after rehabilitation, however there is currently a lack of evidence about preventing falls in this population. This paper describes the study protocol for the FLASSH (FaLls prevention After Stroke Survivors return Home project. Methods and design This randomised controlled trial aims to evaluate the effectiveness of a multi-factorial falls prevention program for stroke survivors who are at high risk of falling when they return home after rehabilitation. Intervention will consist of a home exercise program as well as individualised falls prevention and injury minimisation strategies based on identified risk factors for falls. Additionally, two sub-studies will be implemented in order to explore other key areas related to falls in this population. The first of these is a longitudinal study evaluating the relationship between fear of falling, falls and function over twelve months, and the second evaluates residual impairment in gait stability and obstacle crossing twelve months after discharge from rehabilitation. Discussion The results of the FLASSH project will inform falls prevention practice for stroke survivors. If the falls prevention program is shown to be effective, low cost strategies to prevent falls can be implemented for those at risk around the time of discharge from rehabilitation, thus improving safety and quality of life for stroke survivors. The two sub-studies will contribute to the overall understanding and management of falls risk in stroke survivors. Trial registration This trial is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN012607000398404.

  15. Use of magnetic resonance imaging in short stature: data from National Cooperative Growth Study (NCGS) Substudy 8.

    Kemp, Stephen F; Alter, Craig A; Dana, Ken; Baptista, Joyce; Blethen, Sandra L

    2002-05-01

    The primary use of magnetic resonance imaging (MRI) in the evaluation of children with short stature (SS) is to discover lesions in the central nervous system (CNS), particularly tumors that may require intervention. MRI has a secondary role in identifying structural abnormalities responsible for growth hormone deficiency (GHD). We examined data from the National Cooperative Growth Study (NCGS) Substudy 8 to determine how American physicians are using MRI in evaluating children with SS. Of the 21,738 short children enrolled in NCGS, 5% underwent MRI during their follow-up. Children who had GH stimulation testing were more likely to have had an MRI than those in whom no GH stimulation test was performed (19% vs 2%, p 10 ng/ml), respectively. Abnormalities unrelated to the hypothalamus or pituitary represented 30% of these findings, while disorders in pituitary anatomy, including pituitary hypoplasia, pituitary stalk interruption, and ectopic posterior pituitary, represented an additional 30% of abnormal MRI examinations. CNS tumors comprised 23% of abnormal findings in these patients. We conclude that MRI provides significant value in the evaluation of children with SS, by identifying CNS tumors associated with growth failure as well as anatomical abnormalities of the pituitary. These findings are useful in confirming the diagnosis of GHD in children and identifying potential candidates for continued GH replacement in adulthood.

  16. Adherence to antiretroviral prophylaxis for HIV prevention: a substudy cohort within a clinical trial of serodiscordant couples in East Africa.

    Jessica E Haberer

    Full Text Available Randomized clinical trials of oral antiretroviral pre-exposure prophylaxis (PrEP for HIV prevention have widely divergent efficacy estimates, ranging from 0% to 75%. These discrepancies are likely due to differences in adherence. To our knowledge, no studies to date have examined the impact of improving adherence through monitoring and/or intervention, which may increase PrEP efficacy, or reported on objective behavioral measures of adherence, which can inform PrEP effectiveness and implementation.Within the Partners PrEP Study (a randomized placebo-controlled trial of oral tenofovir and emtricitabine/tenofovir among HIV-uninfected members of serodiscordant couples in Kenya and Uganda, we collected objective measures of PrEP adherence using unannounced home-based pill counts and electronic pill bottle monitoring. Participants received individual and couples-based adherence counseling at PrEP initiation and throughout the study; counseling was intensified if unannounced pill count adherence fell to 80% adherence. Study limitations include potential shortcomings of the adherence measures and use of a convenience sample within the substudy cohort.The high PrEP adherence achieved in the setting of active adherence monitoring and counseling support was associated with a high degree of protection from HIV acquisition by the HIV-uninfected partner in heterosexual serodiscordant couples. Low PrEP adherence was associated with sexual behavior, alcohol use, younger age, and length of PrEP use. Please see later in the article for the Editors' Summary.

  17. Critical factors for optimising skill-grade-mix based on principles of Lean Management - a qualitative substudy

    Inauen, Alice; Rettke, Horst; Fridrich, Annemarie; Spirig, Rebecca; Bauer, Georg F

    2017-01-01

    Background: Due to scarce resources in health care, staff deployment has to meet the demands. To optimise skill-grade-mix, a Swiss University Hospital initiated a project based on principles of Lean Management. The project team accompanied each participating nursing department and scientifically evaluated the results of the project. Aim: The aim of this qualitative sub-study was to identify critical success factors of this project. Method: In four focus groups, participants discussed their experience of the project. Recruitment was performed from departments assessing the impact of the project retrospectively either positive or critical. In addition, the degree of direct involvement in the project served as a distinguishing criterion. Results: While the degree of direct involvement in the project was not decisive, conflicting opinions and experiences appeared in the groups with more positive or critical project evaluation. Transparency, context and attitude proved critical for the project’s success. Conclusions: Project managers should ensure transparency of the project’s progress and matching of the project structure with local conditions in order to support participants in their critical or positive attitude towards the project.

  18. Bioabsorbable polymer-coated sirolimus-eluting stent implantation preserves coronary vasomotion: A DESSOLVE II trial sub-study.

    Rusinaru, Dan; Vrolix, Mathias; Verheye, Stefan; Chowdhary, Saqib; Schoors, Danny; Di Mario, Carlo; Desmet, Walter; Donohoe, Dennis J; Ormiston, John A; Knape, Charlene; Bezerra, Hiram; Lansky, Alexandra; Wijns, William

    2015-12-01

    We studied coronary vasomotion in patients treated with the Mistent(®) absorbable polymer sirolimus-eluting stent (APSES) and in patients implanted with the Endeavor(®) zotarolimus-eluting stent (ZES). First generation (1st-gen) drug-eluting stents (DES) induce persistent vasomotor dysfunction in the treated coronary artery. It is unknown whether and to what extent the implantation of an absorbable polymer DES impairs coronary vasomotion. This sub-study of the DESSOLVE II trial included 19 APSES Mistent(®) and 10 ZES Endeavor(®) patients. Incremental atrial pacing and quantitative coronary angiography were used to assess vasomotion proximal and distal to the stent and in a reference segment at 9 months after implantation. Percent changes in vessel diameter with pacing versus baseline were calculated and compared. Vasomotor response of the APSES group was also compared with changes observed in a historical group of 17 patients implanted with a 1st-gen sirolimus-eluting stent (SES). Normal vasomotion (vasodilatation) was preserved and of comparable magnitude in the APSES and in the ZES group both proximally (P = 0.34) and distally (P = 0.38) to the stent. This finding was not observed in the 1st-gen SES group showing marked pacing-induced vasoconstriction at both stent edges (P absorbable polymer sirolimus-eluting stent is associated with preserved coronary vasomotion, comparable to that observed after implantation of the Endeavor(®) ZES, and distinct from 1st-gen SES which induce coronary vasomotor dysfunction. © 2015 Wiley Periodicals, Inc.

  19. Adherence to antiretroviral prophylaxis for HIV prevention: a substudy cohort within a clinical trial of serodiscordant couples in East Africa.

    Haberer, Jessica E; Baeten, Jared M; Campbell, James; Wangisi, Jonathan; Katabira, Elly; Ronald, Allan; Tumwesigye, Elioda; Psaros, Christina; Safren, Steven A; Ware, Norma C; Thomas, Katherine K; Donnell, Deborah; Krows, Meighan; Kidoguchi, Lara; Celum, Connie; Bangsberg, David R

    2013-01-01

    Randomized clinical trials of oral antiretroviral pre-exposure prophylaxis (PrEP) for HIV prevention have widely divergent efficacy estimates, ranging from 0% to 75%. These discrepancies are likely due to differences in adherence. To our knowledge, no studies to date have examined the impact of improving adherence through monitoring and/or intervention, which may increase PrEP efficacy, or reported on objective behavioral measures of adherence, which can inform PrEP effectiveness and implementation. Within the Partners PrEP Study (a randomized placebo-controlled trial of oral tenofovir and emtricitabine/tenofovir among HIV-uninfected members of serodiscordant couples in Kenya and Uganda), we collected objective measures of PrEP adherence using unannounced home-based pill counts and electronic pill bottle monitoring. Participants received individual and couples-based adherence counseling at PrEP initiation and throughout the study; counseling was intensified if unannounced pill count adherence fell to counseling, and HIV testing. A total of 1,147 HIV-uninfected participants were enrolled: 53% were male, median age was 34 years, and median partnership duration was 8.5 years. Fourteen HIV infections occurred among adherence study participants--all of whom were assigned to placebo (PrEP efficacy = 100%, 95% confidence interval 83.7%-100%, pmarriage were associated with >80% adherence. Study limitations include potential shortcomings of the adherence measures and use of a convenience sample within the substudy cohort. The high PrEP adherence achieved in the setting of active adherence monitoring and counseling support was associated with a high degree of protection from HIV acquisition by the HIV-uninfected partner in heterosexual serodiscordant couples. Low PrEP adherence was associated with sexual behavior, alcohol use, younger age, and length of PrEP use. Please see later in the article for the Editors' Summary.

  20. The relationship of hip joint space to self reported hip pain. A survey of 4.151 subjects of the Copenhagen City Heart Study: the Osteoarthritis Substudy

    Jacobsen, Steffen; Sonne-Holm, Stig; Søballe, Kjeld

    2004-01-01

    OBJECTIVES: (1) To evaluate the effect of pelvic orientation on measurements of hip joint space widths (JSW) in cadaver pelvic radiographs, thereby validating the pelvic radiographs of the Copenhagen City Heart Study: The Osteoarthritis Substudy (CCHS III) cohort of 4.152 subjects, and (2...... was significantly associated to self reported pain in or around the hip joint in both sexes. CONCLUSION: Measurements of minimum hip JSW did not seem to be significantly influenced by varying spatial orientation of the pelvis during X-ray recordings. An inclusion criteria of minimum JSW

  1. European multicentre double-blind placebo-controlled trial of Nilvadipine in mild-to-moderate Alzheimer's disease-the substudy protocols: NILVAD frailty; NILVAD blood and genetic biomarkers; NILVAD cerebrospinal fluid biomarkers; NILVAD cerebral blood flow

    Meulenbroek, O.V.; O'Dwyer, S.; Jong, D. de; Spijker, G.J. van; Kennelly, S.; Cregg, F.; Olde Rikkert, M.G.M.; Abdullah, L.; Wallin, A.; Walsh, C.; Coen, R.; Kenny, R.A.; Daly, L.; Segurado, R.; Borjesson-Hanson, A.; Crawford, F.; Mullan, M.; Lucca, U.; Banzi, R.; Pasquier, F.; Breuilh, L.; Riepe, M.; Kalman, J.; Molloy, W.; Tsolaki, M.; Howard, R.; Adams, J.; Gaynor, S.; Lawlor, B.

    2016-01-01

    INTRODUCTION: In conjunction with the NILVAD trial, a European Multicentre Double-Blind Placebo Controlled trial of Nilvadipine in Mild-to-Moderate Alzheimer's disease (AD), there are four NILVAD substudies in which eligible NILVAD patients are also invited to participate. The main NILVAD protocol

  2. Adaptive servo-ventilation for central sleep apnoea in systolic heart failure: results of the major substudy of SERVE-HF.

    Cowie, Martin R; Woehrle, Holger; Wegscheider, Karl; Vettorazzi, Eik; Lezius, Susanne; Koenig, Wolfgang; Weidemann, Frank; Smith, Gillian; Angermann, Christiane; d'Ortho, Marie-Pia; Erdmann, Erland; Levy, Patrick; Simonds, Anita K; Somers, Virend K; Zannad, Faiez; Teschler, Helmut

    2018-03-01

    The SERVE-HF trial investigated the impact of treating central sleep apnoea (CSA) with adaptive servo-ventilation (ASV) in patients with systolic heart failure. A preplanned substudy was conducted to provide insight into mechanistic changes underlying the observed effects of ASV, including assessment of changes in left ventricular function, ventricular remodelling, and cardiac, renal and inflammatory biomarkers. In a subset of the 1325 randomised patients, echocardiography, cardiac magnetic resonance imaging (cMRI) and biomarker analysis were performed at baseline, and 3 and 12 months. In secondary analyses, data for patients with baseline and 12-month values were evaluated; 312 patients participated in the substudy. The primary endpoint, change in echocardiographically determined left ventricular ejection fraction from baseline to 12 months, did not differ significantly between the ASV and the control groups. There were also no significant between-group differences for changes in left ventricular dimensions, wall thickness, diastolic function or right ventricular dimensions and ejection fraction (echocardiography), and on cMRI (in small patient numbers). Plasma N-terminal pro B-type natriuretic peptide concentration decreased in both groups, and values were similar at 12 months. There were no significant between-group differences in changes in cardiac, renal and systemic inflammation biomarkers. In patients with systolic heart failure and CSA, addition of ASV to guideline-based medical management had no statistically significant effect on cardiac structure and function, or on cardiac biomarkers, renal function and systemic inflammation over 12 months. The increased cardiovascular mortality reported in SERVE-HF may not be related to adverse remodelling or worsening heart failure. © 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.

  3. A nested mechanistic sub-study into the effect of tranexamic acid versus placebo on intracranial haemorrhage and cerebral ischaemia in isolated traumatic brain injury: study protocol for a randomised controlled trial (CRASH-3 Trial Intracranial Bleeding Mechanistic Sub-Study [CRASH-3 IBMS]).

    Mahmood, Abda; Roberts, Ian; Shakur, Haleema

    2017-07-17

    Tranexamic acid prevents blood clots from breaking down and reduces bleeding. However, it is uncertain whether tranexamic acid is effective in traumatic brain injury. The CRASH-3 trial is a randomised controlled trial that will examine the effect of tranexamic acid (versus placebo) on death and disability in 13,000 patients with traumatic brain injury. The CRASH-3 trial hypothesizes that tranexamic acid will reduce intracranial haemorrhage, which will reduce the risk of death. Although it is possible that tranexamic acid will reduce intracranial bleeding, there is also a potential for harm. In particular, tranexamic acid may increase the risk of cerebral thrombosis and ischaemia. The protocol detailed here is for a mechanistic sub-study nested within the CRASH-3 trial. This mechanistic sub-study aims to examine the effect of tranexamic acid (versus placebo) on intracranial bleeding and cerebral ischaemia. The CRASH-3 Intracranial Bleeding Mechanistic Sub-Study (CRASH-3 IBMS) is nested within a prospective, double-blind, multi-centre, parallel-arm randomised trial called the CRASH-3 trial. The CRASH-3 IBMS will be conducted in a cohort of approximately 1000 isolated traumatic brain injury patients enrolled in the CRASH-3 trial. In the CRASH-3 IBMS, brain scans acquired before and after randomisation are examined, using validated methods, for evidence of intracranial bleeding and cerebral ischaemia. The primary outcome is the total volume of intracranial bleeding measured on computed tomography after randomisation, adjusting for baseline bleeding volume. Secondary outcomes include progression of intracranial haemorrhage (from pre- to post-randomisation scans), new intracranial haemorrhage (seen on post- but not pre-randomisation scans), intracranial haemorrhage following neurosurgery, and new focal ischaemic lesions (seen on post-but not pre-randomisation scans). A linear regression model will examine whether receipt of the trial treatment can predict haemorrhage

  4. Risk of Acute Kidney Injury in Patients Randomized to a Restrictive Versus Liberal Approach to Red Blood Cell Transfusion in Cardiac Surgery: A Substudy Protocol of the Transfusion Requirements in Cardiac Surgery III Noninferiority Trial

    Amit X. Garg

    2018-01-01

    Full Text Available Background: When safe to do so, avoiding blood transfusions in cardiac surgery can avoid the risk of transfusion-related infections and other complications while protecting a scarce resource and reducing costs. This protocol describes a kidney substudy of the Transfusion Requirements in Cardiac Surgery III (TRICS-III trial, a multinational noninferiority randomized controlled trial to determine whether the risk of major clinical outcomes in patients undergoing planned cardiac surgery with cardiopulmonary bypass is no greater with a restrictive versus liberal approach to red blood cell transfusion. Objective: The objective of this substudy is to determine whether the risk of acute kidney injury is no greater with a restrictive versus liberal approach to red blood cell transfusion, and whether this holds true in patients with and without preexisting chronic kidney disease. Design and Setting: Multinational noninferiority randomized controlled trial conducted in 73 centers in 19 countries (2014-2017. Patients: Patients (~4800 undergoing planned cardiac surgery with cardiopulmonary bypass. Measurements: The primary outcome of this substudy is perioperative acute kidney injury, defined as an acute rise in serum creatinine from the preoperative value (obtained in the 30-day period before surgery, where an acute rise is defined as ≥26.5 μmol/L in the first 48 hours after surgery or ≥50% in the first 7 days after surgery. Methods: We will report the absolute risk difference in acute kidney injury and the 95% confidence interval. We will repeat the primary analysis using alternative definitions of acute kidney injury, including staging definitions, and will examine effect modification by preexisting chronic kidney disease (defined as a preoperative estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m 2 . Limitations: It is not possible to blind patients or providers to the intervention; however, objective measures will be used to assess

  5. Higher Protein Intake Is Not Associated with Decreased Kidney Function in Pre-Diabetic Older Adults Following a One-Year Intervention—A Preview Sub-Study

    Grith Møller

    2018-01-01

    Full Text Available Concerns about detrimental renal effects of a high-protein intake have been raised due to an induced glomerular hyperfiltration, since this may accelerate the progression of kidney disease. The aim of this sub-study was to assess the effect of a higher intake of protein on kidney function in pre-diabetic men and women, aged 55 years and older. Analyses were based on baseline and one-year data in a sub-group of 310 participants included in the PREVIEW project (PREVention of diabetes through lifestyle Intervention and population studies in Europe and around the World. Protein intake was estimated from four-day dietary records and 24-hour urinary urea excretion. We used linear regression to assess the association between protein intake after one year of intervention and kidney function markers: creatinine clearance, estimated glomerular filtration rate (eGFR, urinary albumin/creatinine ratio (ACR, urinary urea/creatinine ratio (UCR, serum creatinine, and serum urea before and after adjustments for potential confounders. A higher protein intake was associated with a significant increase in UCR (p = 0.03 and serum urea (p = 0.05 after one year. There were no associations between increased protein intake and creatinine clearance, eGFR, ACR, or serum creatinine. We found no indication of impaired kidney function after one year with a higher protein intake in pre-diabetic older adults.

  6. High density lipoprotein structural changes and drug response in lipidomic profiles following the long-term fenofibrate therapy in the FIELD substudy.

    Laxman Yetukuri

    Full Text Available In a recent FIELD study the fenofibrate therapy surprisingly failed to achieve significant benefit over placebo in the primary endpoint of coronary heart disease events. Increased levels of atherogenic homocysteine were observed in some patients assigned to fenofibrate therapy but the molecular mechanisms behind this are poorly understood. Herein we investigated HDL lipidomic profiles associated with fenofibrate treatment and the drug-induced Hcy levels in the FIELD substudy. We found that fenofibrate leads to complex HDL compositional changes including increased apoA-II, diminishment of lysophosphatidylcholines and increase of sphingomyelins. Ethanolamine plasmalogens were diminished only in a subgroup of fenofibrate-treated patients with elevated homocysteine levels. Finally we performed molecular dynamics simulations to qualitatively reconstitute HDL particles in silico. We found that increased number of apoA-II excludes neutral lipids from HDL surface and apoA-II is more deeply buried in the lipid matrix than apoA-I. In conclusion, a detailed molecular characterization of HDL may provide surrogates for predictors of drug response and thus help identify the patients who might benefit from fenofibrate treatment.

  7. Prospective validation of immunological infiltrate for prediction of response to neoadjuvant chemotherapy in HER2-negative breast cancer--a substudy of the neoadjuvant GeparQuinto trial.

    Issa-Nummer, Yasmin; Darb-Esfahani, Silvia; Loibl, Sibylle; Kunz, Georg; Nekljudova, Valentina; Schrader, Iris; Sinn, Bruno Valentin; Ulmer, Hans-Ullrich; Kronenwett, Ralf; Just, Marianne; Kühn, Thorsten; Diebold, Kurt; Untch, Michael; Holms, Frank; Blohmer, Jens-Uwe; Habeck, Jörg-Olaf; Dietel, Manfred; Overkamp, Friedrich; Krabisch, Petra; von Minckwitz, Gunter; Denkert, Carsten

    2013-01-01

    We have recently described an increased lymphocytic infiltration rate in breast carcinoma tissue is a significant response predictor for anthracycline/taxane-based neoadjuvant chemotherapy (NACT). The aim of this study was to prospectively validate the tumor-associated lymphocyte infiltrate as predictive marker for response to anthracycline/taxane-based NACT. The immunological infiltrate was prospectively evaluated in a total of 313 core biopsies from HER2 negative patients of the multicenter PREDICT study, a substudy of the neoadjuvant GeparQuinto study. Intratumoral lymphocytes (iTuLy), stromal lymphocytes (strLy) as well as lymphocyte-predominant breast cancer (LPBC) were evaluated by histopathological assessment. Pathological complete response (pCR) rates were analyzed and compared between the defined subgroups using the exact test of Fisher. Patients with lymphocyte-predominant breast cancer (LPBC) had a significantly increased pCR rate of 36.6%, compared to non-LPBC patients (14.3%, pimmunological infiltrate in breast tumor tissue is predictive for response to anthracycline/taxane-based NACT. Patients with LPBC and increased stromal lymphocyte infiltration have significantly increased pCR rates. The lymphocytic infiltrate is a promising additional parameter for histopathological evaluation of breast cancer core biopsies.

  8. Ibrutinib for patients with rituximab-refractory Waldenström's macroglobulinaemia (iNNOVATE): an open-label substudy of an international, multicentre, phase 3 trial.

    Dimopoulos, Meletios A; Trotman, Judith; Tedeschi, Alessandra; Matous, Jeffrey V; Macdonald, David; Tam, Constantine; Tournilhac, Olivier; Ma, Shuo; Oriol, Albert; Heffner, Leonard T; Shustik, Chaim; García-Sanz, Ramón; Cornell, Robert F; de Larrea, Carlos Fernández; Castillo, Jorge J; Granell, Miquel; Kyrtsonis, Marie-Christine; Leblond, Veronique; Symeonidis, Argiris; Kastritis, Efstathios; Singh, Priyanka; Li, Jianling; Graef, Thorsten; Bilotti, Elizabeth; Treon, Steven; Buske, Christian

    2017-02-01

    In the era of widespread rituximab use for Waldenström's macroglobulinaemia, new treatment options for patients with rituximab-refractory disease are an important clinical need. Ibrutinib has induced durable responses in previously treated patients with Waldenström's macroglobulinaemia. We assessed the efficacy and safety of ibrutinib in a population with rituximab-refractory disease. This multicentre, open-label substudy was done at 19 sites in seven countries in adults aged 18 years and older with confirmed Waldenström's macroglobulinaemia, refractory to rituximab and requiring treatment. Disease refractory to the last rituximab-containing therapy was defined as either relapse less than 12 months since last dose of rituximab or failure to achieve at least a minor response. Key exclusion criteria included: CNS involvement, a stroke or intracranial haemorrhage less than 12 months before enrolment, clinically significant cardiovascular disease, hepatitis B or hepatitis C viral infection, and a known bleeding disorder. Patients received oral ibrutinib 420 mg once daily until progression or unacceptable toxicity. The substudy was not prospectively powered for statistical comparisons, and as such, all the analyses are descriptive in nature. This study objectives were the proportion of patients with an overall response, progression-free survival, overall survival, haematological improvement measured by haemoglobin, time to next treatment, and patient-reported outcomes according to the Functional Assessment of Cancer Therapy-Anemia (FACT-An) and the Euro Qol 5 Dimension Questionnaire (EQ-5D-5L). All analyses were per protocol. The study is registered at ClinicalTrials.gov, number NCT02165397, and follow-up is ongoing but enrolment is complete. Between Aug 18, 2014, and Feb 18, 2015, 31 patients were enrolled. Median age was 67 years (IQR 58-74); 13 (42%) of 31 patients had high-risk disease per the International Prognostic Scoring System Waldenstr

  9. Motivation to physical activity among adults with high risk of type 2 diabetes who participated in the Oulu substudy of the Finnish Diabetes Prevention Study.

    Korkiakangas, Eveliina; Taanila, Anja M; Keinänen-Kiukaanniemi, Sirkka

    2011-01-01

    Type 2 diabetes can be prevented by lifestyle changes such as sufficient level of physical activity. The number of persons at high risk of or diagnosed with type 2 diabetes is increasing all over the world. In order to prevent type 2 diabetes and develop exercise counselling, more studies on motivators and barriers to physical activity are needed. Thus, the aim of this qualitative study was to describe the motivators and barriers to physical activity among individuals with high risk of type 2 diabetes who participated in a substudy of the Finnish Diabetes Prevention Study in Oulu and to consider whether the motivators or barriers changed during the follow-up from 2003 to 2008. Questionnaires with open-ended questions were conducted twice: in the first follow-up in 2003 altogether 63 participants answered the questionnaire (n = 93), and in the second follow-up in 2008 altogether 71 participants answered the questionnaire (n = 82). Thus, response rate was 68% in 2003 and 87% in 2008. The study was conducted in the city of Oulu in Finland. Qualitative data were analysed by inductive content analysis using the QSR NVivo 8 software. The results of this study showed that motivators to physical activity included weight management, feelings of physical and mental well being. In addition, social relationships associated with exercise were also motivators. In conclusion, we present that regular counselling is important in order to promote exercise among older people, and that motivators to exercise are strengthened by positive experiences of exercise as one grows older. © 2010 Blackwell Publishing Ltd.

  10. Help seeking behavior and onset-to-alarm time in patients with acute stroke: sub-study of the preventive antibiotics in stroke study.

    Zock, E; Kerkhoff, H; Kleyweg, R P; van Bavel-Ta, T B V; Scott, S; Kruyt, N D; Nederkoorn, P J; van de Beek, D

    2016-11-25

    Patients with acute stroke often do not seek immediate medical help, which is assumed to be driven by lack of knowledge of stroke symptoms. We explored the process of help seeking behavior in patients with acute stroke, evaluating knowledge about stroke symptoms, socio-demographic and clinical characteristics, and onset-to-alarm time (OAT). In a sub-study of the Preventive Antibiotics in Stroke Study (PASS), 161 acute stroke patients were prospectively included in 3 Dutch hospitals. A semi-structured questionnaire was used to assess knowledge, recognition and interpretation of stroke symptoms. With in-depth interviews, response actions and reasons were explored. OAT was recorded and associations with socio-demographic, clinical parameters were assessed. Knowledge about stroke symptoms does not always result in correct recognition of own stroke symptoms, neither into correct interpretation of the situation and subsequent action. In our study population of 161 patients with acute stroke, median OAT was 30 min (interquartile range [IQR] 10-150 min). Recognition of one-sided weakness and/or sensory loss (p = 0.046) and adequate interpretation of the stroke situation (p = 0.003), stroke at daytime (p = 0.002), severe stroke (p = 0.003), calling the emergency telephone number (p = 0.004), and transport by ambulance (p = 0.040) were associated with shorter OAT. Help seeking behavior after acute stroke is a complex process. A shorter OAT after stroke is associated with correct recognition of one-sided weakness and/or sensory loss, adequate interpretation of the stroke situation by the patient and stroke characteristics and logistics of stroke care, but not by knowledge of stroke symptoms.

  11. Optical Coherence Tomography Substudy of A Prospective Multicenter Randomized Post-Market Trial to Assess the Safety and Effectiveness of the Firehawk™ Rapamycin Target Eluting Cobalt Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesions: TARGET All Comers.

    Baumbach, Andreas; Lansky, Alexandra J; Onuma, Yoshi; Asano, Taku; Johnson, Thomas; Anderson, Richard; Kiemeneij, Ferdinand; Zheng, Ming; Van Royen, Niels; Slagboom, Ton; Vlachojannis, Georg; Xu, Bo; Serruys, Patrick; Wijns, William

    2018-06-12

    Durable polymer drug-eluting stents (DP DES) may contribute to persistent inflammation, delayed endothelial healing and subsequent late DES thrombosis. The aim of this Optical Coherence Tomography (OCT) sub-study was to compare healing and neointimal coverage of a novel bioabsorbable polymer sirolimus-eluting stent (FIREHAWK®) (BP DES) versus the DP DES (XIENCE) at 90 days in an all comers patient population. The TARGET All Comers study is a prospective multicenter randomised post-market trial of 1656 patients randomised 1:1 to FIREHAWK or XIENCE at 21 centers in 10 European countries. The TARGET OCT sub-study enrolled 36 consecutive patients with 52 lesions at 6 centers proficient in OCT. Follow-up OCT was performed at 3 months or prior to revascularisation when occurring before the 3-month window. The substudy was designed for non-inferiority of the primary endpoint of neointimal thickness. At follow-up, the mean neointimal thickness by OCT (52 lesions, Firehawk, n=24; Xience, n=28), was not significantly different between groups (Firehawk 75.5μm vs Xience V 82.3 μm) meeting the primary endpoint of non-inferiority (Pnoninferiority<0.001). The percentage of stent strut coverage was high in both groups (strut level: 99.9% ± 0.3 vs 100% ± 0.1, p=0.26), and the proportion of malapposed struts (1.0±1.6% vs. 1.2±2.0%, p=0.51) was low in both groups. Based on OCT, the FIREHAWK BP DES has a similar healing response 3 months after implantation compared to the DP DES, with near complete strut coverage, moderate neointima formation and minimal strut malapposition.

  12. Risk of Acute Kidney Injury in Patients Randomized to a Restrictive Versus Liberal Approach to Red Blood Cell Transfusion in Cardiac Surgery: A Substudy Protocol of the Transfusion Requirements in Cardiac Surgery III Noninferiority Trial.

    Garg, Amit X; Shehata, Nadine; McGuinness, Shay; Whitlock, Richard; Fergusson, Dean; Wald, Ron; Parikh, Chirag; Bagshaw, Sean M; Khanykin, Boris; Gregory, Alex; Syed, Summer; Hare, Gregory M T; Cuerden, Meaghan S; Thorpe, Kevin E; Hall, Judith; Verma, Subodh; Roshanov, Pavel S; Sontrop, Jessica M; Mazer, C David

    2018-01-01

    When safe to do so, avoiding blood transfusions in cardiac surgery can avoid the risk of transfusion-related infections and other complications while protecting a scarce resource and reducing costs. This protocol describes a kidney substudy of the Transfusion Requirements in Cardiac Surgery III (TRICS-III) trial, a multinational noninferiority randomized controlled trial to determine whether the risk of major clinical outcomes in patients undergoing planned cardiac surgery with cardiopulmonary bypass is no greater with a restrictive versus liberal approach to red blood cell transfusion. The objective of this substudy is to determine whether the risk of acute kidney injury is no greater with a restrictive versus liberal approach to red blood cell transfusion, and whether this holds true in patients with and without preexisting chronic kidney disease. Multinational noninferiority randomized controlled trial conducted in 73 centers in 19 countries (2014-2017). Patients (~4800) undergoing planned cardiac surgery with cardiopulmonary bypass. The primary outcome of this substudy is perioperative acute kidney injury, defined as an acute rise in serum creatinine from the preoperative value (obtained in the 30-day period before surgery), where an acute rise is defined as ≥26.5 μmol/L in the first 48 hours after surgery or ≥50% in the first 7 days after surgery. We will report the absolute risk difference in acute kidney injury and the 95% confidence interval. We will repeat the primary analysis using alternative definitions of acute kidney injury, including staging definitions, and will examine effect modification by preexisting chronic kidney disease (defined as a preoperative estimated glomerular filtration rate [eGFR] blood cell transfusion in the presence of anemia during cardiac surgery done with cardiopulmonary bypass. www.clinicaltrials.gov; clinical trial registration number NCT 02042898.

  13. Comparison of cardiac troponins I and T measured with high-sensitivity methods for evaluation of prognosis in atrial fibrillation: an ARISTOTLE substudy.

    Hijazi, Ziad; Siegbahn, Agneta; Andersson, Ulrika; Lindahl, Bertil; Granger, Christopher B; Alexander, John H; Atar, Dan; Gersh, Bernard J; Hanna, Michael; Harjola, Veli-Pekka; Horowitz, John; Husted, Steen; Hylek, Elaine M; Lopes, Renato D; McMurray, John J V; Wallentin, Lars

    2015-02-01

    Although cardiac troponin is associated with outcomes in atrial fibrillation (AF), the complementary prognostic information provided by cardiac troponin I (cTnI) and cTnT is unknown. This study investigated the distribution, determinants, and prognostic value of cTnI and cTnT concentrations in patients with AF. Samples were collected. At the time of randomization, we analyzed cTnI and cTnT concentrations of 14806 AF patients in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial using high-sensitivity assays. Correlations (Spearman), determinants (multivariable linear regression), and outcomes (adjusted Cox models and c-statistics) were investigated. Concentrations of cTnI and cTnT were correlated (r = 0.70) and measurable in most participants [cTnI 98.5% (median 5.4 ng/L, ≥99th percentile in 9.2%) and cTnT 93.5% (median 10.9 ng/L, ≥99th percentile in 34.4%)]. Renal impairment was the most important factor affecting the concentrations of both troponins. cTnI increase was more associated with heart failure, vascular disease, and persistent/permanent AF, and cTnT with age, male sex, and diabetes. Over a median 1.9 years of follow-up, patients with both troponins above the median had significantly higher risk for stroke/systemic embolism [hazard ratio (HR) 1.72 (95% CI 1.31-2.27)], cardiac death [3.14 (2.35-4.20)], and myocardial infarction [2.99 (1.78-5.03)] than those with both troponins below median (all P Chemistry.

  14. Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan: a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial.

    Ovesen, Christian; Jakobsen, Janus Christian; Gluud, Christian; Steiner, Thorsten; Law, Zhe; Flaherty, Katie; Dineen, Rob A; Bath, Philip M; Sprigg, Nikola; Christensen, Hanne

    2018-06-13

    We present the statistical analysis plan of a prespecified Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 sub-study aiming to investigate, if tranexamic acid has a different effect in intracerebral haemorrhage patients with the spot sign on admission compared to spot sign negative patients. The TICH-2 trial recruited above 2000 participants with intracerebral haemorrhage arriving in hospital within 8 h after symptom onset. They were included irrespective of radiological signs of on-going haematoma expansion. Participants were randomised to tranexamic acid versus matching placebo. In this subgroup analysis, we will include all participants in TICH-2 with a computed tomography angiography on admission allowing adjudication of the participants' spot sign status. Primary outcome will be the ability of tranexamic acid to limit absolute haematoma volume on computed tomography at 24 h (± 12 h) after randomisation among spot sign positive and spot sign negative participants, respectively. Within all outcome measures, the effect of tranexamic acid in spot sign positive/negative participants will be compared using tests of interaction. This sub-study will investigate the important clinical hypothesis that spot sign positive patients might benefit more from administration of tranexamic acid compared to spot sign negative patients. Trial registration ISRCTN93732214 ( http://www.isrctn.com ).

  15. Design and Rationale of the Intima-Medial Thickness Sub-Study of the PreventIon of CArdiovascular Events in iSchemic Stroke Patients with High Risk of Cerebral hemOrrhage (PICASSO-IMT) Study.

    Seo, Woo-Keun; Kim, Yong Jae; Lee, Juneyoung; Kwon, Sun U

    2017-09-01

    Atherosclerosis is one of the main mechanisms of stroke and cardiovascular diseases and is associated with increased risk of recurrent stroke and cardiovascular events. Intima-medial thickness (IMT) is a well-known surrogate marker of atherosclerosis and has been used to predict stroke and cardiovascular events. However, the clinical significance of IMT and IMT change in stroke has not been investigated in well-designed studies. The PreventIon of CArdiovascular events in iSchemic Stroke patients with high risk of cerebral hemOrrhage-Intima-Media Thickness (PICASSO-IMT) sub-study is designed to investigate the effects of cilostazol, probucol, or both on IMT in patients with stroke. PICASSO-IMT is a prospective sub-study of the PICASSO study designed to measure IMT and plaque score at 1, 13, 25, 37, and 49 months after randomization. The primary outcome is the change in mean carotid IMT, which is defined as the mean of the far-wall IMTs of the right and left common carotid arteries, between baseline and 13 months after randomization. PICASSO-IMT will provide the largest IMT data set in a stroke population and will provide valuable information about the clinical significance of IMT in patients with ischemic stroke. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  16. Practice of mechanical ventilation in cardiac arrest patients and effects of targeted temperature management: A substudy of the targeted temperature management trial.

    Harmon, Matthew B A; van Meenen, David M P; van der Veen, Annelou L I P; Binnekade, Jan M; Dankiewicz, Josef; Ebner, Florian; Nielsen, Niklas; Pelosi, Paolo; Schultz, Marcus J; Horn, Janneke; Friberg, Hans; Juffermans, Nicole P

    2018-05-12

    Mechanical ventilation practices in patients with cardiac arrest are not well described. Also, the effect of temperature on mechanical ventilation settings is not known. The aims of this study were 1) to describe practice of mechanical ventilation and its relation with outcome 2) to determine effects of different target temperatures strategies (33 °C versus 36 °C) on mechanical ventilation settings. This is a substudy of the TTM-trial in which unconscious survivors of a cardiac arrest due to a cardiac cause were randomized to two TTM strategies, 33 °C (TTM33) and 36 °C (TTM36). Mechanical ventilation data were obtained at three time points: 1) before TTM; 2) at the end of TTM (before rewarming) and 3) after rewarming. Logistic regression was used to determine an association between mechanical ventilation variables and outcome. Repeated-measures mixed modelling was performed to determine the effect of TTM on ventilation settings. Mechanical ventilation data was available for 567 of the 950 TTM patients. Of these, 81% was male with a mean (SD) age of 64 (12) years. At the end of TTM median tidal volume was 7.7 ml/kg predicted body weight (PBW)(6.4-8.7) and 60% of patients were ventilated with a tidal volume ≤ 8 ml/kg PBW. Median PEEP was 7.7cmH 2 O (6.4-8.7) and mean driving pressure was 14.6 cmH 2 O (±4.3). The median FiO 2 fraction was 0.35 (0.30-0.45). Multivariate analysis showed an independent relationship between increased respiratory rate and 28-day mortality. TTM33 resulted in lower end-tidal CO 2 (Pgroup = 0.0003) and higher alveolar dead space fraction (Pgroup = 0.003) compared to TTM36, while PCO 2 levels and respiratory minute volume were similar between groups. In the majority of the cardiac arrest patients, protective ventilation settings are applied, including low tidal volumes and driving pressures. High respiratory rate was associated with mortality. TTM33 results in lower end-tidal CO 2 levels and a higher alveolar dead

  17. Effectiveness of compression stockings to prevent the post-thrombotic syndrome (The SOX Trial and Bio-SOX biomarker substudy: a randomized controlled trial

    Rodger Marc A

    2007-07-01

    Full Text Available Abstract Background Post thrombotic syndrome (PTS is a burdensome and costly complication of deep venous thrombosis (DVT that develops in 20–40% of patients within 1–2 years after symptomatic DVT. Affected patients have chronic leg pain and swelling and may develop ulcers. Venous valve disruption from the thrombus itself or thrombus-associated mediators of inflammation is considered to be a key initiating event for the development of venous hypertension that often underlies PTS. As existing treatments for PTS are extremely limited, strategies that focus on preventing the development of PTS in patients with DVT are more likely to be effective and cost-effective in reducing its burden. Elastic compression stockings (ECS could be helpful in preventing PTS; however, data on their effectiveness are scarce and conflicting. Methods/Design The SOX Trial is a randomized, allocation concealed, double-blind multicenter clinical trial. The objective of the study is to evaluate ECS to prevent PTS. A total of 800 patients with proximal DVT will be randomized to one of 2 treatment groups: ECS or placebo (inactive stockings worn on the DVT-affected leg daily for 2 years. The primary outcome is the incidence of PTS during follow-up. Secondary outcomes are severity of PTS, venous thromboembolism (VTE recurrence, death from VTE, quality of life and cost-effectiveness. Outcomes will be evaluated during 6 clinic visits and 2 telephone follow ups. At baseline, 1 and 6 months, blood samples will be obtained to evaluate the role of inflammatory mediators and genetic markers of thrombophilia in the development of PTS (Bio-SOX substudy. Discussion The SOX Trial will be the largest study and the first with a placebo control to evaluate the effectiveness of ECS to prevent PTS. It is designed to provide definitive data on the effects of ECS on the occurrence and severity of PTS, as well as DVT recurrence, cost-effectiveness and quality of life. This study will also

  18. Value of the 12-lead electrocardiogram to define the level of obstruction in acute anterior wall myocardial infarction: correlation to coronary angiography and clinical outcome in the DANAMI-2 trial

    Eskola, Markku J; Nikus, Kjell C; Holmvang, Lene

    2008-01-01

    was studied. RESULTS: In 146 patients without confounding factors on the ECG, either ST-elevation>or=0.5 mm in lead aVL or any ST-elevation in lead aVR in association with precordial ST-segment elevation in at least two contiguous leads (including V2, V3 or V4) had a sensitivity of 94%, specificity of 49...

  19. Ferritin levels, inflammatory biomarkers, and mortality in peripheral arterial disease: a substudy of the Iron (Fe) and Atherosclerosis Study (FeAST) Trial.

    Depalma, Ralph G; Hayes, Virginia W; Chow, Bruce K; Shamayeva, Galina; May, Patricia E; Zacharski, Leo R

    2010-06-01

    This study delineated correlations between ferritin, inflammatory biomarkers, and mortality in a cohort of 100 cancer-free patients with peripheral arterial disease (PAD) participating in the Veterans Affairs (VA) Cooperative Study #410, the Iron (Fe) and Atherosclerosis Study (FeAST). FeAST, a prospective, randomized, single-blind clinical trial, tested the hypothesis that reduction of iron stores using phlebotomy would influence clinical outcomes in 1227 PAD patients randomized to iron reduction or control groups. The effects of statin administration were also examined in the Sierra Nevada Health Care (SNHC) cohort by measuring serum ferritin levels at entry and during the 6-year study period. No difference was documented between treatment groups in all-cause mortality and secondary outcomes of death plus nonfatal myocardial infarction and stroke. Iron reduction in the main study caused a significant age-related improvement in cardiovascular disease outcomes, new cancer diagnoses, and cancer-specific death. Tumor necrosis factor (TNF)-alpha, TNF-alpha receptors 1 and 2, interleukin (IL)-2, IL-6, IL-10, and high-sensitivity C reactive protein (hs-CRP) were measured at entry and at 6-month intervals for 6 years. Average levels of ferritin and lipids at entry and at the end of the study were compared. The clinical course and ferritin levels of 23 participants who died during the study were reviewed. At entry, mean age of entry was 67 +/- 9 years for the SNHCS cohort, comparable to FeAST and clinical and laboratory parameters were equivalent in substudy participants randomized to iron reduction (n = 51) or control (n = 49). At baseline, 53 participants on statins had slightly lower mean entry-level ferritin values (114.06 ng/mL; 95% confidence interval [CI] 93.43-134.69) vs the 47 off statins (127.62 ng/mL; 95% CI, 103.21-152.02). Longitudinal analysis of follow-up data, after adjusting for the phlebotomy treatment effect, showed that statin use was associated with

  20. MR-proADM as a Prognostic Marker in Patients With ST-Segment-Elevation Myocardial Infarction-DANAMI-3 (a Danish Study of Optimal Acute Treatment of Patients With STEMI) Substudy

    Falkentoft, Alexander C; Rørth, Rasmus; Iversen, Kasper

    2018-01-01

    BACKGROUND: Midregional proadrenomedullin (MR-proADM) has demonstrated prognostic potential after myocardial infarction (MI). Yet, the prognostic value of MR-proADM at admission has not been examined in patients with ST-segment-elevation MI (STEMI). METHODS AND RESULTS: The aim of this substudy......, DANAMI-3 (The Danish Study of Optimal Acute Treatment of Patients with ST-segment-elevation myocardial infarction), was to examine the associations of admission concentrations of MR-proADM with short- and long-term mortality and hospital admission for heart failure in patients with ST......-segment-elevation myocardial infarction. Outcomes were assessed using Cox proportional hazard models and area under the curve using receiver operating characteristics. In total, 1122 patients were included. The median concentration of MR-proADM was 0.64 nmol/L (25th-75th percentiles, 0.53-0.79). Within 30 days 23 patients (2...

  1. Effect of ADRB2 polymorphisms on the efficacy of salmeterol and tiotropium in preventing COPD exacerbations: a prespecified substudy of the POET-COPD trial.

    Rabe, Klaus F; Fabbri, Leonardo M; Israel, Elliot; Kögler, Harald; Riemann, Kathrin; Schmidt, Hendrik; Glaab, Thomas; Vogelmeier, Claus F

    2014-01-01

    The effect of β2-adrenergic receptor (ADRB2) polymorphisms on the treatment response to longacting bronchodilators in chronic obstructive pulmonary disease (COPD) is unclear. We aimed to establish whether ADRB2 polymorphisms differentially affected COPD exacerbation outcomes in response to tiotropium versus salmeterol. We did a prespecified analysis of the ADRB2 polymorphisms Arg16Gly and Gln27Glu within the 1 year randomised, double-blind, double-dummy, parallel-group Prevention Of Exacerbations with Tiotropium in COPD (POET-COPD) trial, comparing the effects of treatment with tiotropium or salmeterol on exacerbations in 7376 patients with COPD. One blood sample was collected for pharmacogenetic testing from each patient who elected to participate in the substudy. Random assignment of patients to treatment groups was not stratified according to genotypes. Genomic DNA was extracted from whole-blood specimens and samples were genotyped for the two SNPs, rs1042713 (Arg16Gly) and rs1042714 (Gln27Glu). All assays were done in technical duplicates and 10% of samples that were randomly chosen were repeated as technical duplicates in a second independent genotyping process. Our primary endpoint was the risk of a first exacerbation of COPD based on time to first exacerbation data. An exacerbation of COPD was defined as the increase or new onset of more than one symptom of COPD (cough, sputum, wheezing, dyspnoea, or chest tightness), with at least one of the symptoms lasting for 3 days or more and needing treatment with antibiotics or systemic glucocorticoids (moderate exacerbations), or admission to hospital (severe exacerbations). POET-COPD is registered with ClinicalTrials.gov, number NCT00563381. 5125 patients gave informed consent for genotyping. The distributions of ADRB2 genotypes were well matched among groups. Polymorphisms at aminoacid 27 did not affect exacerbation outcomes. In the salmeterol group, patients with Arg16Arg genotype had a significantly reduced

  2. DNA-thioguanine nucleotide concentration and relapse-free survival during maintenance therapy of childhood acute lymphoblastic leukaemia (NOPHO ALL2008): a prospective substudy of a phase 3 trial.

    Nielsen, Stine Nygaard; Grell, Kathrine; Nersting, Jacob; Abrahamsson, Jonas; Lund, Bendik; Kanerva, Jukka; Jónsson, Ólafur Gísli; Vaitkeviciene, Goda; Pruunsild, Kaie; Hjalgrim, Lisa Lyngsie; Schmiegelow, Kjeld

    2017-04-01

    Adjustment of mercaptopurine and methotrexate maintenance therapy of acute lymphoblastic leukaemia by leucocyte count is confounded by natural variations. Cytotoxicity is primarily mediated by DNA-incorporated thioguanine nucleotides (DNA-TGN). The aim of this study was to establish whether DNA-TGN concentrations in blood leucocytes during maintenance therapy are associated with relapse-free survival. In this substudy of the NOPHO ALL2008 phase 3 trial done in 23 hospitals in seven European countries (Denmark, Estonia, Finland, Iceland, Lithuania, Norway, and Sweden), we analysed data from centralised and blinded analyses of 6-mercaptopurine and methotrexate metabolites in blood samples from patients with non-high-risk childhood acute lymphoblastic leukaemia. Eligible patients were aged 1·0-17·9 years; had been diagnosed with non-high-risk precursor B-cell or T-cell leukaemia; had been treated according to the Nordic Society of Pediatric Hematology and Oncology ALL2008 protocol; and had reached maintenance therapy in first remission. Maintenance therapy was (mercaptopurine 75 mg/m 2 once per day and methotrexate 20 mg/m 2 once per week, targeted to a leucocyte count of 1·5-3·0 × 10 9 cells per L). We measured DNA-TGN and erythrocyte concentrations of TGN nucleotides, methylated mercaptopurine metabolites, and methotrexate polyglutamates. The primary objective was the association of DNA-TGN concentrations and 6-mercaptopurine and methotrexate metabolites with relapse-free survival. The secondary endpoint was the assessment of DNA-TGN concentration and 6-mercaptopurine and methotrexate metabolites during maintenance therapy phase 2. Between Nov 26, 2008 and June 14, 2016, 1509 patients from the NOPHO ALL2008 study were assessed for eligibility in the DNA-TGN substudy, of which 918 (89%) of 1026 eligible patients had at least one DNA-TGN measurement and were included in the analyses. Median follow-up was 4·6 years (IQR 3·1-6·1). Relapse-free survival was

  3. ST-segment resolution with bivalirudin versus heparin and routine glycoprotein IIb/IIIa inhibitors started in the ambulance in ST-segment elevation myocardial infarction patients transported for primary percutaneous coronary intervention: The EUROMAX ST-segment resolution substudy.

    Van't Hof, Arnoud; Giannini, Francesco; Ten Berg, Jurrien; Tolsma, Rudolf; Clemmensen, Peter; Bernstein, Debra; Coste, Pierre; Goldstein, Patrick; Zeymer, Uwe; Hamm, Christian; Deliargyris, Efthymios; Steg, Philippe G

    2017-08-01

    Myocardial reperfusion after primary percutaneous coronary intervention (PCI) can be assessed by the extent of post-procedural ST-segment resolution. The European Ambulance Acute Coronary Syndrome Angiography (EUROMAX) trial compared pre-hospital bivalirudin and pre-hospital heparin or enoxaparin with or without GPIIb/IIIa inhibitors (GPIs) in primary PCI. This nested substudy was performed in centres routinely using pre-hospital GPI in order to compare the impact of randomized treatments on ST-resolution after primary PCI. Residual cumulative ST-segment deviation on the single one hour post-procedure electrocardiogram (ECG) was assessed by an independent core laboratory and was the primary endpoint. It was calculated that 762 evaluable patients were needed to show non-inferiority (85% power, alpha 2.5%) between randomized treatments. A total of 871 participated with electrocardiographic data available in 824 patients (95%). Residual ST-segment deviation one hour after PCI was 3.8±4.9 mm versus 3.9±5.2 mm for bivalirudin and heparin+GPI, respectively ( p=0.0019 for non-inferiority). Overall, there were no differences between randomized treatments in any measures of ST-segment resolution either before or after the index procedure. Pre-hospital treatment with bivalirudin is non-inferior to pre-hospital heparin + GPI with regard to residual ST-segment deviation or ST-segment resolution, reflecting comparable myocardial reperfusion with the two strategies.

  4. Bone mineral density and inflammatory and bone biomarkers after darunavir-ritonavir combined with either raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults with HIV-1: a substudy of the NEAT001/ANRS143 randomised trial.

    Bernardino, Jose I; Mocroft, Amanda; Mallon, Patrick W; Wallet, Cedrick; Gerstoft, Jan; Russell, Charlotte; Reiss, Peter; Katlama, Christine; De Wit, Stephane; Richert, Laura; Babiker, Abdel; Buño, Antonio; Castagna, Antonella; Girard, Pierre-Marie; Chene, Genevieve; Raffi, Francois; Arribas, Jose R

    2015-11-01

    Osteopenia, osteoporosis, and low bone mineral density are frequent in patients with HIV. We assessed the 96 week loss of bone mineral density associated with a nucleoside or nucleotide reverse transcriptase inhibitor (NtRTI)-sparing regimen. Antiretroviral-naive adults with HIV were enrolled in 78 clinical sites in 15 European countries into a randomised (1:1), open-label, non-inferiority trial (NEAT001/ANRS143) assessing the efficacy and safety of darunavir (800 mg once per day) and ritonavir (100 mg once per day) plus either raltegravir (400 mg twice per day; NtRTI-sparing regimen) or tenofovir (245 mg once per day) and emtricitabine (200 mg once per day; standard regimen). For this bone-health substudy, 20 of the original sites in six countries participated, and any patient enrolled at one of these sites who met the following criteria was eligible: plasma viral loads greater than 1000 HIV RNA copies per mL and CD4 cell counts of fewer than 500 cells per μL, except in those with symptomatic HIV infection. Exclusion criteria included treatment for malignant disease, testing positive for hepatitis B virus surface antigen, pregnancy, creatinine clearance less than 60 mL per min, treatment for osteoporosis, systemic steroids, or oestrogen-replacement therapy. The two primary endpoints were the mean percentage changes in lumbar spine and total hip bone mineral density at week 48, assessed by dual energy x-ray absorptiometry (DXA) scans. We did the analysis with an intention-to-treat-exposed approach with antiretroviral modifications ignored. The parent trial is registered with ClinicalTrials.gov, number NCT01066962, and is closed to new participants. Between Aug 2, 2010, and April 18, 2011, we recruited 146 patients to the substudy, 70 assigned to the NtRTI-sparing regimen and 76 to the standard regimen. DXA data were available for 129, 121 and 107 patients at baseline, 48 and 96 weeks respectively. At week 48, the mean percentage loss in bone mineral density in the

  5. B vitamins and magnetic resonance imaging-detected ischemic brain lesions in patients with recent transient ischemic attack or stroke: the VITAmins TO Prevent Stroke (VITATOPS) MRI-substudy.

    Cavalieri, Margherita; Schmidt, Reinhold; Chen, Christopher; Mok, Vincent; de Freitas, Gabriel R; Song, Swithin; Yi, Qilong; Ropele, Stefan; Grazer, Anja; Homayoon, Nina; Enzinger, Christian; Loh, Katherine; Wong, Ka Sing Lawrence; Wong, Adrian; Xiong, Yunyun; Chang, Hui Meng; Wong, Meng Cheong; Fazekas, Franz; Eikelboom, John W; Hankey, Graeme J

    2012-12-01

    Elevated concentrations of homocysteine are associated with cerebral small vessel disease (CSVD). B-vitamin supplementation with folate and vitamins B12 and B6 reduces homocysteine concentrations. In a substudy of the VITAmins TO Prevent Stroke (VITATOPS) trial, we assessed the hypothesis that the addition of once-daily supplements of B vitamins would reduce the progression of CSVD-related brain lesions. A total of 359 patients with recent stroke or transient ischemic attack, who were randomly allocated to double-blind treatment with placebo or b vitamins, underwent brain MRI at randomization and after 2 years of B-vitamin supplementation. MR images were analyzed blinded to treatment allocation. Outcomes related to the prespecified hypothesis were progression of white matter hyperintensities and incident lacunes. We also explored the effect of B-vitamin supplementation on the incidence of other ischemic abnormalities. After 2 years of treatment with b vitamins or placebo, there was no significant difference in white matter hyperintensities volume change (0.08 vs 0.13 cm3; P=0.419) and incidence of lacunes (8.0% vs 5.9%, P=0.434; odds ratio=1.38). In a subanalysis of patients with MRI evidence of severe CSVD at baseline, b-vitamin supplementation was associated with a significant reduction in white matter hyperintensities volume change (0.3 vs 1.7 cm3; P=0.039). Daily B-vitamin supplementation for 2 years did not significantly reduce the progression of brain lesions resulting from presumed CSVD in all patients with recent stroke or transient ischemic attack but may do so in the subgroup of patients with recent stroke or transient ischemic attack and severe CSVD. http://vitatops.highway1.com.au/. Unique identifier: NCT00097669 and ISRCTN74743444.

  6. Efficacy and Safety of the Absorb Everolimus-Eluting Bioresorbable Scaffold for Treatment of Patients With Diabetes Mellitus: Results of the Absorb Diabetic Substudy.

    Kereiakes, Dean J; Ellis, Stephen G; Kimura, Takeshi; Abizaid, Alexandre; Zhao, Weiying; Veldhof, Susan; Vu, Minh-Thien; Zhang, Zhen; Onuma, Yoshinobu; Chevalier, Bernard; Serruys, Patrick W; Stone, Gregg W

    2017-01-09

    The study sought to evaluate the efficacy and safety of the Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) (Abbott Vascular, Abbott Park, Illinois) in patients with diabetes mellitus. Randomized, controlled trials have demonstrated comparable clinical outcomes following percutaneous coronary intervention with either Absorb BVS or metallic Xience everolimus-eluting stent. However, these trials lack power required to provide reliable treatment effect estimates in this high-risk population. In a pre-specified, powered analysis, patients with diabetes who received ≥1 Absorb were pooled from the ABSORB II, III, and JAPAN randomized trials and from the single arm ABSORB EXTEND registry. The study composite primary endpoint was target lesion failure (TLF) at 1 year following Absorb BVS compared with a performance goal of 12.7%. Among 754 diabetic patients included in analysis (27.3% insulin treated), the 1-year TLF rate was 8.3% (upper 1-sided 95% confidence limit: 10.1%; p = 0.0001 vs. performance goal). Scaffold thrombosis (definite or probable) was observed in 2.3% of patients. Multivariable regression identified older age, insulin treatment, and smaller pre-procedure reference vessel diameter as significant independent predictors of 1-year TLF. The Absorb diabetic substudy suggests efficacy and safety of the Absorb BVS for treatment of patients with diabetes mellitus. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  7. Quality of Life With Ivabradine in Patients With Angina Pectoris: The Study Assessing the Morbidity-Mortality Benefits of the If Inhibitor Ivabradine in Patients With Coronary Artery Disease Quality of Life Substudy.

    Tendera, Michal; Chassany, Olivier; Ferrari, Roberto; Ford, Ian; Steg, Philippe Gabriel; Tardif, Jean-Claude; Fox, Kim

    2016-01-01

    To explore the effect of ivabradine on angina-related quality of life (QoL) in patients participating in the Study Assessing the Morbidity-Mortality Benefits of the If Inhibitor Ivabradine in Patients with Coronary Artery Disease (SIGNIFY) QoL substudy. QoL was evaluated in a prespecified subgroup of SIGNIFY patients with angina (Canadian Cardiovascular Society class score, ≥ 2 at baseline) using the Seattle Angina Questionnaire and a generic visual analogue scale on health status. Data were available for 4187 patients (2084 ivabradine and 2103 placebo). There were improvements in QoL in both treatment groups. The primary outcome of change in physical limitation score at 12 months was 4.56 points for ivabradine versus 3.40 points for placebo (E, 0.96; 95% confidence interval, -0.14 to 2.05; P=0.085). The ivabradine-placebo difference in physical limitation score was significant at 6 months (P=0.048). At 12 months, the visual analogue scale and the other Seattle Angina Questionnaire dimensions were higher among ivabradine-treated patients, notably angina frequency (Pangina frequency (P=0.034). The effect on QoL was maintained over the study duration, and ivabradine patients had better scores on angina frequency at every visit to 36 months. Treatment with ivabradine did not affect the primary outcome of change in physical limitation score at 12 months. It did produce consistent improvements in other self-reported QoL parameters related to angina pectoris, notably in terms of angina frequency and disease perception. URL: http://www.isrctn.com. Unique identifier: ISRCTN61576291. © 2015 American Heart Association, Inc.

  8. An eHealth Diary and Symptom-Tracking Tool Combined With Person-Centered Care for Improving Self-Efficacy After a Diagnosis of Acute Coronary Syndrome: A Substudy of a Randomized Controlled Trial.

    Wolf, Axel; Fors, Andreas; Ulin, Kerstin; Thorn, Jörgen; Swedberg, Karl; Ekman, Inger

    2016-02-23

    Patients with cardiovascular diseases managed by a person-centered care (PCC) approach have been observed to have better treatment outcomes and satisfaction than with traditional care. eHealth may facilitate the often slow transition to more person-centered health care by increasing patients' beliefs in their own capacities (self-efficacy) to manage their care trajectory. eHealth is being increasingly used, but most studies continue to focus on health care professionals' logic of care. Knowledge is lacking regarding the effects of an eHealth tool on self-efficacy when combined with PCC for patients with chronic heart diseases. The objective of our study was to investigate the effect of an eHealth diary and symptom-tracking tool in combination with PCC for patients with acute coronary syndrome (ACS). This was a substudy of a randomized controlled trial investigating the effects of PCC in patients hospitalized with ACS. In total, 199 patients with ACS aged eHealth tool, or both, for at least 2 months after hospital discharge. The primary end point was a composite score of changes in general self-efficacy, return to work or prior activity level, and rehospitalization or death 6 months after discharge. Of the 94 patients in the intervention arm, 37 (39%) used the eHealth tool at least once after the index hospitalization. Most of these (24/37, 65%) used the mobile app and not the Web-based app as the primary source of daily self-rating input. Patients used the eHealth tool a mean of 38 times during the first 8 weeks (range 1-118, SD 33) and 64 times over a 6-month period (range 1-597, SD 104). Patients who used the eHealth tool in combination with the PCC intervention had a 4-fold improvement in the primary end point compared with the control group (odds ratio 4.0, 95% CI 1.5-10.5; P=.005). This improvement was driven by a significant increase in general self-efficacy compared with the control group (P=.011). Patients in the PCC group who did not use the eHealth tool

  9. A randomized comparison of novel bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent in patients with acute coronary syndromes: The CENTURY II high risk ACS substudy

    Jiménez, Victor A.; Iñiguez, Andrés; Baz, José A.; Valdés, Mariano; Ortiz, Alberto; Vuilliomenet, André; Mainar, Vicente; Dudek, Dariusz; Banai, Shmuel; Tüller, David; Bonnet, Jean-Louis; De Miguel, Antonio; Bastos, Guillermo; Wijns, William; Saito, Shigeru

    2016-01-01

    Background: To investigate clinical outcomes of percutaneous coronary intervention using a sirolimus-eluting stent with bioresorbable polymer, Ultimaster (BP-SES) compared with a permanent polymer everolimus-eluting stent, Xience (PP-EES) in patients with high risk (ST-segment elevation and non-ST-segment elevation myocardial infarction) acute coronary syndromes (ACS) enrolled in the CENTURY II trial. Methods: CENTURY II is a prospective, multicenter, randomized, single blind, controlled trial comparing BP-SES and PP-EES, with primary endpoint of target lesion failure (TLF) at 9 month post-stent implantation. Out of 1123 patients enrolled in CENTURY II trial, 264 high risk ACS patients were included in this subgroup analysis, and the clinical outcomes including target lesion failure (TLF), target vessel failure (TVF), cardiac death, myocardial infarction, and stent thrombosis were evaluated at 24 months. Results: The baseline clinical, angiographic and procedural characteristics were similar between two groups. At 24 months, TLF occurred in 6.3% of patients receiving a BP-SES and 6.5% of patients receiving a PP-EES (P = 0.95); TVF was 6.3% in patients receiving a BP-SES and 9.4% in patients receiving a PP-EES (P = 0.36). There were no significant differences in cardiac death, myocardial infarction and stent thrombosis rate. Conclusions: BP-SES achieved similar safety and efficacy outcomes as PP-EES in this ACS subgroup of CENTURY II study, at 24-month follow-up. This finding is hypothesis-generating and needs to be confirmed in larger trials with longer follow-up. - Highlights: • This study reported the 24-month clinical outcomes of new-generation BP-SES compared with PP-EES in ACS subgroup from CENTURY II study. • This is a pre-specified subgroup analysis of a large randomized, prospective, multicenter clinical trial. • The BP-SES showed good and comparable clinical performance as PP-EES at 24 months. • This substudy has a relatively small sample size and

  10. Retrospective quality control review of FDG scans in the imaging sub-study of PALETTE EORTC 62072/VEG110727: a randomized, double-blind, placebo-controlled phase III trial

    Hristova, Ivalina [European Organization for Research and Treatment of Cancer Headquarters, Brussels (Belgium); Radboud University Medical Centre, Department of Nuclear Medicine, Nijmegen (Netherlands); Boellaard, Ronald [VU University Medical Centre, Department of Radiology and Nuclear Medicine, Amsterdam (Netherlands); Vogel, Wouter [The Netherlands Cancer Institute - Antoni van Leeuwenhoek, Department of Nuclear Medicine, Amsterdam (Netherlands); Mottaghy, Felix [Maastricht University, Department of Nuclear Medicine, Maastricht (Netherlands); Marreaud, Sandrine; Collette, Sandra [European Organization for Research and Treatment of Cancer Headquarters, Brussels (Belgium); Schoeffski, Patrick [University Hospitals Leuven, Department of General Medical Oncology, Leuven Cancer Institute, Department of Oncology, KU Leuven (Belgium); Sanfilippo, Roberta [Istituto Nazionale Tumori, Milano (Italy); Dewji, Raz [GlaxoSmithKline, Oncology R and D, Uxbridge (United Kingdom); Graaf, Winette van der [Radboud University Medical Centre, Department of Medical Oncology, Nijmegen (Netherlands); Oyen, Wim J.G. [Radboud University Medical Centre, Department of Nuclear Medicine, Nijmegen (Netherlands)

    2015-05-01

    {sup 18}F-Labelled fluorodeoxyglucose (FDG) can detect early changes in tumour metabolism and may be a useful quantitative imaging biomarker (QIB) for prediction of disease stabilization, response and duration of progression-free survival (PFS). Standardization of imaging procedures is a prerequisite, especially in multicentre clinical trials. In this study we reviewed the quality of FDG scans and compliance with the imaging guideline (IG) in a phase III clinical trial. Forty-four cancer patients were enrolled in an imaging sub-study of a randomized international multicentre trial. FDG scan had to be performed at baseline and 10-14 days after treatment start. The image transmittal forms (ITFs) and Digital Imaging and Communications in Medicine (DICOM) [1] standard headers were analysed for compliance with the IG. Mean liver standardized uptake values (LSUV{sub mean}) were measured as recommended by positron emission tomography (PET) Response Criteria in Solid Tumors 1.0 (PERCIST) [2]. Of 88 scans, 81 were received (44 patients); 36 were properly anonymized; 77/81 serum glucose values submitted, all but one within the IG. In 35/44 patients both scans were of sufficient visual quality. In 22/70 ITFs the reported UT differed by >1 min from the DICOM headers (max. difference 1 h 4 min). Based on the DICOM, UT compliance for both scans was 31.4 %. LSUV{sub mean} was fairly constant for the 11 patients with UT compliance: 2.30 ± 0.33 at baseline and 2.27 ± 0.48 at follow-up (FU). Variability substantially increased for the subjects with unacceptable UT (11 patients): 2.27 ± 1.04 at baseline and 2.18 ± 0.83 at FU. The high attrition number of patients due to low compliance with the IG compromised the quantitative assessment of the predictive value for early response monitoring. This emphasizes the need for better regulated procedures in imaging departments, which may be achieved by education of involved personnel or efforts towards regulations. LSUV{sub mean} could be

  11. A randomized comparison of novel bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent in patients with acute coronary syndromes: The CENTURY II high risk ACS substudy

    Jiménez, Victor A., E-mail: victor.alfonso.jimenez.diaz@sergas.es [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Iñiguez, Andrés; Baz, José A. [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Valdés, Mariano [Hospital Universitario V. Arrixaca, Murcia (Spain); Ortiz, Alberto [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Vuilliomenet, André [Kantonsspital Aarau, Aarau (Switzerland); Mainar, Vicente [Department of Cardiology, University General Hospital of Alicante, Alicante (Spain); Dudek, Dariusz [Department of Interventional Cardiology, Jagiellonian University Medical College, Krakow (Poland); Banai, Shmuel [Tel Aviv Sourasky Medical Centre, Tel Aviv (Israel); Tüller, David [Department of Cardiology, Stadtspital Triemli, Zürich (Switzerland); Bonnet, Jean-Louis [Department of Cardiology, Hospital La Timone, Marseille (France); De Miguel, Antonio; Bastos, Guillermo [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Wijns, William [Cardiovascular Center Aalst, OLV Hospital, Aalst (Belgium); Saito, Shigeru [Department of Cardiology and Catheterization Laboratory, Shonan Kamakura General Hospital, Kamakura (Japan)

    2016-09-15

    Background: To investigate clinical outcomes of percutaneous coronary intervention using a sirolimus-eluting stent with bioresorbable polymer, Ultimaster (BP-SES) compared with a permanent polymer everolimus-eluting stent, Xience (PP-EES) in patients with high risk (ST-segment elevation and non-ST-segment elevation myocardial infarction) acute coronary syndromes (ACS) enrolled in the CENTURY II trial. Methods: CENTURY II is a prospective, multicenter, randomized, single blind, controlled trial comparing BP-SES and PP-EES, with primary endpoint of target lesion failure (TLF) at 9 month post-stent implantation. Out of 1123 patients enrolled in CENTURY II trial, 264 high risk ACS patients were included in this subgroup analysis, and the clinical outcomes including target lesion failure (TLF), target vessel failure (TVF), cardiac death, myocardial infarction, and stent thrombosis were evaluated at 24 months. Results: The baseline clinical, angiographic and procedural characteristics were similar between two groups. At 24 months, TLF occurred in 6.3% of patients receiving a BP-SES and 6.5% of patients receiving a PP-EES (P = 0.95); TVF was 6.3% in patients receiving a BP-SES and 9.4% in patients receiving a PP-EES (P = 0.36). There were no significant differences in cardiac death, myocardial infarction and stent thrombosis rate. Conclusions: BP-SES achieved similar safety and efficacy outcomes as PP-EES in this ACS subgroup of CENTURY II study, at 24-month follow-up. This finding is hypothesis-generating and needs to be confirmed in larger trials with longer follow-up. - Highlights: • This study reported the 24-month clinical outcomes of new-generation BP-SES compared with PP-EES in ACS subgroup from CENTURY II study. • This is a pre-specified subgroup analysis of a large randomized, prospective, multicenter clinical trial. • The BP-SES showed good and comparable clinical performance as PP-EES at 24 months. • This substudy has a relatively small sample size and

  12. Exercise capacity and N-terminal pro-brain natriuretic peptide levels with biventricular vs. right ventricular pacing for atrioventricular block: results from the PREVENT-HF German Substudy.

    Stockburger, Martin; de Teresa, Eduardo; Lamas, Gervasio; Desaga, Martin; Koenig, Carsten; Habedank, Dirk; Cobo, Erik; Navarro, Xavier; Wiegand, Uwe

    2014-01-01

    Previous studies showed unfavourable effects of right ventricular (RV) pacing. Ventricular pacing (VP), however, is required in many patients with atrioventricular (AV) block. The PREVENT-HF study explored left ventricular (LV) remodelling during RV vs. biventricular (BIV) pacing in AV block without advanced heart failure. The pre-specified PREVENT-HF German Substudy examined exercise capacity and N-terminal pro-brain natriuretic peptide (NT-proBNP). Patients with expected VP ≥80% were randomized to RV or BIV pacing. Endpoints were peak oxygen uptake (pVO2), oxygen uptake at the anaerobic threshold (VO2AT), ventilatory efficiency (VE/VCO2), and logNT-proBNP. Considering crossover, intention to treat (ITT), and on-treatment (OT) analyses of covariance (ANCOVA) were performed. For exercise testing 44 (RV: 25, BIV: 19), and for NT-proBNP 53 patients (RV: 29, BIV: 24) were included. The ITT analysis revealed significant differences in pVO2 [ANCOVA effect 2.83 mL/kg/min, confidence interval (CI) 0.83-4.91, P = 0.007], VO2AT (ANCOVA effect 2.14 mL/min/k, CI 0.14-4.15, P = 0.03), and VE/VCO2 (ANCOVA effect -5.46, CI -10.79 to -0.13, P = 0.04) favouring BIV randomization. The significant advantage in pVO2 persisted in OT analysis, while VO2AT and VE/VCO2 showed trends favouring BIV pacing. LogNT-proBNP did not differ between groups. (ITT: ANCOVA effect 0.008, CI -0.40 to +0.41, P = 0.97; OT: ANCOVA effect -0.03, CI -0.44 to 0.30, P = 0.90). Our study suggests that BIV pacing produces better exercise capacity over 1 year compared with RV pacing in patients without advanced heart failure and AV block. In contrast, we observed no significant changes of NT-proBNP. Larger trials will allow appraising the clinical usefulness of BIV pacing in AV block. ClinicalTrials.gov Identifier: NCT00170326.

  13. Body composition and metabolic outcomes after 96 weeks of treatment with ritonavir-boosted lopinavir plus either nucleoside or nucleotide reverse transcriptase inhibitors or raltegravir in patients with HIV with virological failure of a standard first-line antiretroviral therapy regimen: a substudy of the randomised, open-label, non-inferiority SECOND-LINE study.

    Boyd, Mark A; Amin, Janaki; Mallon, Patrick W G; Kumarasamy, Nagalingeswaran; Lombaard, Johan; Wood, Robin; Chetchotisakd, Ploenchan; Phanuphak, Praphan; Mohapi, Lerato; Azwa, Iskandar; Belloso, Waldo H; Molina, Jean-Michel; Hoy, Jennifer; Moore, Cecilia L; Emery, Sean; Cooper, David A

    2017-01-01

    Lipoatrophy is one of the most feared complications associated with the use of nucleoside or nucleotide reverse transcriptase inhibitors (N[t]RTIs). We aimed to assess soft-tissue changes in participants with HIV who had virological failure of a first-line antiretroviral (ART) regimen containing a non-nucleoside reverse transcriptase inhibitor plus two N(t)RTIs and were randomly assigned to receive a second-line regimen containing a boosted protease inhibitor given with either N(t)RTIs or raltegravir. Of the 37 sites that participated in the randomised, open-label, non-inferiority SECOND-LINE study, eight sites from five countries (Argentina, India, Malaysia, South Africa, and Thailand) participated in the body composition substudy. All sites had a dual energy x-ray absorptiometry (DXA) scanner and all participants enrolled in SECOND-LINE were eligible for inclusion in the substudy. Participants were randomly assigned (1:1), via a computer-generated allocation schedule, to receive either ritonavir-boosted lopinavir plus raltegravir (raltegravir group) or ritonavir-boosted lopinavir plus two or three N(t)RTIs (N[t]RTI group). Randomisation was stratified by site and screening HIV-1 RNA. Participants and investigators were not masked to group assignment, but allocation was concealed until after interventions were assigned. DXA scans were done at weeks 0, 48, and 96. The primary endpoint was mean percentage and absolute change in peripheral limb fat from baseline to week 96. We did intention-to-treat analyses of available data. This substudy is registered with ClinicalTrials.gov, number NCT01513122. Between Aug 1, 2010, and July 10, 2011, we recruited 211 participants into the substudy. The intention-to-treat population comprised 102 participants in the N(t)RTI group and 108 participants in the raltegravir group, of whom 91 and 105 participants, respectively, reached 96 weeks. Mean percentage change in limb fat from baseline to week 96 was 16·8% (SD 32·6) in the N

  14. Inhibition of platelet aggregation by AZD6140, a reversible oral P2Y12 receptor antagonist, compared with clopidogrel in patients with acute coronary syndromes

    Storey, Robert F; Husted, Steen; Harrington, Robert A

    2007-01-01

    OBJECTIVES: In a substudy of DISPERSE (Dose confIrmation Study assessing anti-Platelet Effects of AZD6140 vs. clopidogRel in non-ST-segment Elevation myocardial infarction)-2, we compared the antiplatelet effects of AZD6140 and clopidogrel and assessed the effects of AZD6140 in clopidogrel...

  15. [Scope of the latest RE-LY substudies: clinical implications].

    Ruiz-Giménez Arrieta, N

    2012-03-01

    The approval of the use of dabiatran in stroke prevention in patients with nonvalvular atrial fibrilation (NVAF) is based on the results of the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial, one of the largest studies to date in this entity. In this trial, dabigatran showed similar safety and efficacy to warfarin in primary and secondary prevention of stroke in patients with AF. At a dose of 150 mg twice daily, dabigatran was superior to warfarin in the prevention of stroke or systemic embolism and the 110 mg dose twice daily showed similar efficacy and greater safety, given the lower incidence of hemorrhage. These results were consistently found in the various subanalyses, with some slight differences of interest for clinical practice. The ideal candidates for dabiatran are patients with NVAF suitable for cardioversion, who require short periods of anticoagulation, patients in remote geographical areas with difficulty in achieving good anticoagulation control or good control with anti-vitamin K treatment due to IRN fluctuations, and patients with a low risk of hemorrhage and a CHADS score ≥ 3 and/or with prior stroke, whenever there are no contraindications. The choice of dabigatran dose should be evaluated according to the patient's individual characteristics (caution must be exercised when prescribing this drug in the elderly and in renal insufficiency) and embolic and/or hemorrhagic risk. Studies of the long-term safety of this drug, pharmacoeconomic analyses in Spain and post-commercialization pharmacovigilance data are required before the definitive uses of this drug can be established. Copyright © 2012 Elsevier España, S.L. All rights reserved.

  16. Aortic root geometry in aortic stenosis patients (a SEAS substudy)

    Bahlmann, Edda; Nienaber, Christoph A; Cramariuc, Dana

    2011-01-01

    -specified requirements for the aortic root geometry for current available prostheses, CoreValve and Edwards-Sapien. The ratio of sinus of Valsalva height to sinus width was 1:2. In multivariate linear regression analysis, larger sinus of Valsalva height was associated with older age, larger sinus of Valsalva diameter......, lower ejection fraction and smaller supracoronary diameter (multiple R(2) = 0.19, PSapien prosthesis in 66.9%. Overall, annular dimension feasible for TAVI using any available prosthesis was found...

  17. [Thrombocytopenia induced by type II heparin and myocardial infarct: 2 case reports].

    Antonijević, Nabojsa; Stanojević, Milica; Perunicić, Jovan; Djokić, Milan; Miković, Danijla; Kovac, Mirjana; Miljić, Predrag; Milosević, Rajko; Terzić, Branka; Vasiljević, Zorana

    2004-01-01

    Heparin-induced thrombocytopenia (HIT) type II is an acquired thrombophylic state and life-threatening immune complication of a heparin treatment mainly clinically manifested by marked thrombocytopenia, frequently by arterial and venous thrombosis, and sometimes by skin changes. Functional assay as heparin aggregation test and 14C-serotonin release assays are used in diagnostics as well as antigen assays of which detection tests for heparin-platelet factor 4 antibodies are most frequently used. Considering the fact that there is no single reliable assays for HIT II detection available, sometimes it is necessary to combine both of the above-mentioned types of assays. We present the case of a 57-year-old patient with an acute anterior myocardial infarction with cardiac insufficiency of III and IV degree according to Killip, recurrent ventricular fibrillation and diabetes mellitus type II developing thrombocytopenia to 37 x 10(9)/l accompanied with typical skin changes. The diagnosis was confirmed by the heparin aggregation test. The second patient aged 70 undergoing the treatment for anteroseptal myocardial infarction and reinfarction of the inferior wall complicated by a cardiogenic shock and acute right bundle branch block developed thrombocytopenia 59 x 10(9)/l on the third day of the heparin therapy, with the remark that he had received a heparin therapy during the first infarction as well. Antibodies against heparin-platelet factor 4 were detected by particle gel ID-HPF4 immuno-assay. In both patients, the disease had a lethal outcome despite all then available therapeutic measures applied. Further on we discuss advantages of certain types of tests, a therapy doctrine, need for urgent therapeutic measures, inclusive of the administration of antithrombins, avoidance of harmful procedures like low-molecular-weight heparins administration and prophylactic platelet transfusion as well as preventive measures.

  18. Optimal duration of eptifibatide infusion in percutaneous coronary intervention (an ESPRIT substudy).

    Rebeiz, Abdallah G; Dery, Jean-Pierre; Tsiatis, Anastasios A; O'shea, J Conor; Johnson, Brent A; Hellkamp, Anne S; Pieper, Karen S; Gilchrist, Ian C; Slater, James; Muhlestein, J Brent; Joseph, Diane; Kitt, Michael M; Tcheng, James E

    2004-10-01

    Although randomized trials have clearly demonstrated the clinical efficacy with regimens of platelet glycoprotein IIb/IIIa antagonists that result in >80% inhibition of baseline platelet aggregation in percutaneous coronary intervention (PCI), there are no data available concerning the optimal duration of infusion of these agents. In an era when the length of hospitalization has a major impact on health care costs, the determination of the optimal duration of the infusion of these drugs after PCI is of great relevance. The investigators therefore sought to determine the optimal length of the infusion of eptifibatide after PCI by analyzing the outcomes of patients enrolled in the Enhanced Suppression of the Platelet IIb/IIIa Receptor With Integrilin Therapy trial who were randomized to treatment with eptifibatide.

  19. Maintenance Categories - A Substudy of the Maintenance Support Structure for Contingency Forces Study (ACN 21012).

    1977-06-23

    as economy , tactical situation and personnel avcilability. Define the levels by commodity as appropriate. (3) Determine the impact of expanded direct...r 0-50 eq. ni i ~~04II! 0 C CCA INSPECT _ _ _ _ _ _ _ _ __ TEST I ~SERVICEg ADJUST j _ __ _ __ _ _ __ _ _ ALIGN CALIBRATE INSTALL It"" WACE REPAIR...and considerations of economy of logistic support r~es ources."’ REASON: See the reason for item 1 above. The &=t-’on of references to TM 38-715-1 in

  20. Heart failure severity, inappropriate ICD therapy, and novel ICD programming: a MADIT-RIT substudy.

    Daimee, Usama A; Vermilye, Katherine; Rosero, Spencer; Schuger, Claudio D; Daubert, James P; Zareba, Wojciech; McNitt, Scott; Polonsky, Bronislava; Moss, Arthur J; Kutyifa, Valentina

    2017-12-01

    The effects of heart failure (HF) severity on risk of inappropriate implantable cardioverter-defibrillator (ICD) therapy have not been thoroughly investigated. We aimed to study the association between HF severity and inappropriate ICD therapy in MADIT-RIT. MADIT-RIT randomized 1,500 patients to three ICD programming arms: conventional (Arm A), high-rate cut-off (Arm B: ≥200 beats/min), and delayed therapy (Arm C: 60-second delay for ≥170 beats/min). We evaluated the association between New York Heart Association (NYHA) class III (n = 256) versus class I-II (n = 251) and inappropriate ICD therapy in Arm A patients with ICD-only and cardiac resynchronization therapy with defibrillator (CRT-D). We additionally assessed benefit of novel ICD programming in Arms B and C versus Arm A by NYHA classification. In Arm A, the risk of inappropriate therapy was significantly higher in those with NYHA III versus NYHA I-II for both ICD (hazard ratio [HR] = 2.55, confidence interval [CI]: 1.51-4.30, P programming significantly reduced inappropriate therapy in patients with both NYHA III (Arm B vs Arm A: HR = 0.08, P programming with high-rate cut-off or delayed detection reduces inappropriate ICD therapies in both mild and moderate HF. © 2017 Wiley Periodicals, Inc.

  1. 77 FR 38840 - Submission for OMB Review; Comment Request: Child Health Disparities Substudy for the National...

    2012-06-29

    ...) Incorporate behavioral, emotional, educational, and contextual consequences to enable a complete assessment of... during the Vanguard phase will inform the implementation and analysis plan for the Main Study. In this... been associated with negative emotional states, cognitive deficits, problem behavior, and a variety of...

  2. Intramyocellular triacylglycerol accumulation across weight loss strategies; Sub-study of the CENTRAL trial.

    Yftach Gepner

    Full Text Available Intramyocellular triacylglycerol (IMTG is utilized as metabolic fuel during exercise and is linked to insulin resistance, but the long-term effect of weight loss strategies on IMTG among participants with abdominal fat, remain unclear.In an 18-month trial, sedentary participants with abdominal fat/dyslipidemia were randomized to either a low-fat (LF or Mediterranean/low-carbohydrate (MED/LC diet (including 28g·day-1 of walnuts. After 6-months, the participants were re-randomized to moderate intense physical activity (PA+ or non-physical activity (PA-. Magnetic resonance imaging (MRI was used to quantify changes of IMTG, abdominal sub-depots, hepatic and intermuscular fats.Across the 277 participants [86% men, age = 48 years, body-mass-index (BMI = 31kg/m2, visceral fat = 33%] 86% completed the 18-m trial. At baseline, women had higher IMTG than men (3.4% vs. 2.3%, p<0.001 and increased IMTG was associated with aging and higher BMI, visceral and intermuscular fats, HbA1c%, HDL-c and leptin(p<0.05, but not with intra-hepatic fat. After 18 month of intervention and a -3 kg mean weight loss, participants significantly increased IMTG by 25%, with a distinct effect in the MED/LCPA+ group as compared to the other intervention groups (57% vs. 9.5-18.5%, p<0.05. Changes in IMTG were associated with visceral and intermuscular fat, metabolic syndrome, insulin and leptin (p<0.05 for all, however, these associations did not remain after adjustment for visceral fat changes.Lifestyle strategies differentially affect IMTG accumulation; combination of exercise with decreased carbohydrate/increased unsaturated fat proportion intake greatly increase IMTG. Our findings suggest that increased IMTG during diet-induced moderate weight loss may not be directly related to cardiometabolic risk.ClinicalTrials.gov NCT01530724.

  3. Intramyocellular triacylglycerol accumulation across weight loss strategies; Sub-study of the CENTRAL trial.

    Gepner, Yftach; Shelef, Ilan; Schwarzfuchs, Dan; Cohen, Noa; Bril, Nitzan; Rein, Michal; Tsaban, Gal; Zelicha, Hila; Yaskolka Meir, Anat; Tene, Lilac; Sarusy, Benjamin; Rosen, Philip; Hoffman, Jay R; Stout, Jeffrey R; Thiery, Joachim; Ceglarek, Uta; Stumvoll, Michael; Blüher, Matthias; Stampfer, Meir J; Shai, Iris

    2017-01-01

    Intramyocellular triacylglycerol (IMTG) is utilized as metabolic fuel during exercise and is linked to insulin resistance, but the long-term effect of weight loss strategies on IMTG among participants with abdominal fat, remain unclear. In an 18-month trial, sedentary participants with abdominal fat/dyslipidemia were randomized to either a low-fat (LF) or Mediterranean/low-carbohydrate (MED/LC) diet (including 28g·day-1 of walnuts). After 6-months, the participants were re-randomized to moderate intense physical activity (PA+) or non-physical activity (PA-). Magnetic resonance imaging (MRI) was used to quantify changes of IMTG, abdominal sub-depots, hepatic and intermuscular fats. Across the 277 participants [86% men, age = 48 years, body-mass-index (BMI) = 31kg/m2, visceral fat = 33%] 86% completed the 18-m trial. At baseline, women had higher IMTG than men (3.4% vs. 2.3%, pvs. 9.5-18.5%, p<0.05). Changes in IMTG were associated with visceral and intermuscular fat, metabolic syndrome, insulin and leptin (p<0.05 for all), however, these associations did not remain after adjustment for visceral fat changes. Lifestyle strategies differentially affect IMTG accumulation; combination of exercise with decreased carbohydrate/increased unsaturated fat proportion intake greatly increase IMTG. Our findings suggest that increased IMTG during diet-induced moderate weight loss may not be directly related to cardiometabolic risk. ClinicalTrials.gov NCT01530724.

  4. Optimizing Radiation Therapy Quality Assurance in Clinical Trials: A TROG 08.03 RAVES Substudy

    Trada, Yuvnik, E-mail: yuvnik@gmail.com [Calvary Mater Newcastle, Waratah, New South Wales (Australia); Kneebone, Andrew [Royal North Shore Hospital, St Lenoards, New South Wales (Australia); Paneghel, Andrea [Peter MacCallum Cancer Centre, Melbourne, Victoria (Australia); Pearse, Maria [Auckland Hospital, Auckland (New Zealand); Sidhom, Mark [Liverpool Hospital, Liverpool, New South Wales (Australia); Tang, Colin [Sir Charles Gairdner Hospital, Nedlands, Western Australia (Australia); Wiltshire, Kirsty; Haworth, Annette [Peter MacCallum Cancer Centre, Melbourne, Victoria (Australia); Fraser-Browne, Carol [Auckland Hospital, Auckland (New Zealand); Martin, Jarad [Calvary Mater Newcastle, Waratah, New South Wales (Australia)

    2015-12-01

    Purpose: To explore site- and clinician-level factors associated with protocol violations requiring real-time-review (RTR) resubmission in a multicenter clinical trial to help tailor future quality assurance (QA) protocols. Methods and Materials: RAVES (Radiation Therapy–Adjuvant vs Early Salvage) (Trans-Tasman Radiation Oncology Group 08.03) is a randomized trial comparing adjuvant with early salvage radiation therapy in men with positive surgical margins or pT3 disease after prostatectomy. Quality assurance in RAVES required each clinician and site to submit a credentialing dummy run (DR) and for each patient's radiation therapy plan to undergo external RTR before treatment. Prospectively defined major violations from trial protocol required remedy and resubmission. Site and clinician factors associated with RTR resubmission were examined using hierarchical modeling. Results: Data were collected from 171 consecutive patients, treated by 46 clinicians at 32 hospitals. There were 47 RTR resubmissions (27%) due to 65 major violations. The relative rate of resubmission decreased by 29% per year as the study progressed (odds ratio OR. 0.71, P=.02). The majority of resubmissions were due to contouring violations (39 of 65) and dosimetric violations (22 of 65). For each additional patient accrued, significant decreases in RTR resubmission were seen at both clinician level (OR 0.75, P=.02) and site level (OR 0.72, P=.01). The rate of resubmission due to dosimetric violations was only 1.6% after the first 5 patients. Use of IMRT was associated with lower rates of resubmission compared with 3-dimensional conformal radiation therapy (OR 0.38, P=.05). Conclusion: Several low- and high-risk factors that may assist with tailoring future clinical trial QA were identified. Because the real-time resubmission rate was largely independent of the credentialing exercise, some form of RTR QA is recommended. The greatest benefit from QA was derived early in trial activation and clinician experience.

  5. Quantitative Myocardial Perfusion Imaging Versus Visual Analysis in Diagnosing Myocardial Ischemia: A CE-MARC Substudy.

    Biglands, John D; Ibraheem, Montasir; Magee, Derek R; Radjenovic, Aleksandra; Plein, Sven; Greenwood, John P

    2018-05-01

    This study sought to compare the diagnostic accuracy of visual and quantitative analyses of myocardial perfusion cardiovascular magnetic resonance against a reference standard of quantitative coronary angiography. Visual analysis of perfusion cardiovascular magnetic resonance studies for assessing myocardial perfusion has been shown to have high diagnostic accuracy for coronary artery disease. However, only a few small studies have assessed the diagnostic accuracy of quantitative myocardial perfusion. This retrospective study included 128 patients randomly selected from the CE-MARC (Clinical Evaluation of Magnetic Resonance Imaging in Coronary Heart Disease) study population such that the distribution of risk factors and disease status was proportionate to the full population. Visual analysis results of cardiovascular magnetic resonance perfusion images, by consensus of 2 expert readers, were taken from the original study reports. Quantitative myocardial blood flow estimates were obtained using Fermi-constrained deconvolution. The reference standard for myocardial ischemia was a quantitative coronary x-ray angiogram stenosis severity of ≥70% diameter in any coronary artery of >2 mm diameter, or ≥50% in the left main stem. Diagnostic performance was calculated using receiver-operating characteristic curve analysis. The area under the curve for visual analysis was 0.88 (95% confidence interval: 0.81 to 0.95) with a sensitivity of 81.0% (95% confidence interval: 69.1% to 92.8%) and specificity of 86.0% (95% confidence interval: 78.7% to 93.4%). For quantitative stress myocardial blood flow the area under the curve was 0.89 (95% confidence interval: 0.83 to 0.96) with a sensitivity of 87.5% (95% confidence interval: 77.3% to 97.7%) and specificity of 84.5% (95% confidence interval: 76.8% to 92.3%). There was no statistically significant difference between the diagnostic performance of quantitative and visual analyses (p = 0.72). Incorporating rest myocardial blood flow values to generate a myocardial perfusion reserve did not significantly increase the quantitative analysis area under the curve (p = 0.79). Quantitative perfusion has a high diagnostic accuracy for detecting coronary artery disease but is not superior to visual analysis. The incorporation of rest perfusion imaging does not improve diagnostic accuracy in quantitative perfusion analysis. Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  6. Atrial antitachycardia pacing and atrial remodeling: A substudy of the international, randomized MINERVA trial.

    Boriani, Giuseppe; Tukkie, Raymond; Biffi, Mauro; Mont, Lluis; Ricci, Renato; Pürerfellner, Helmut; Botto, Giovanni Luca; Manolis, Antonis S; Landolina, Maurizio; Gulizia, Michele; Hudnall, J Harrison; Mangoni, Lorenza; Grammatico, Andrea; Padeletti, Luigi

    2017-10-01

    Atrial tachycardia (AT) and atrial fibrillation (AF) are common in pacemaker patients and are associated with bad prognoses. The purpose of this study was to evaluate atrial antitachycardia pacing impact on AT/AF-induced atrial remodeling, measured by early recurrence of AT/AF (ERAF) and by change in left atrial diameter (LAD), and to evaluate the impact of AT/AF duration on ERAF incidence. Pacemaker patients were randomized to dual-chamber pacing (Control DDDR: 385 patients), managed ventricular pacing (MVP: 398 patients), or atrial antitachycardia pacing plus MVP (DDDRP+MVP: 383 patients). LAD change, estimated by echocardiography, was considered significant if the relative difference between baseline and 24-month measurements was >10%. At median follow-up of 34 months, ERAF incidence was significantly lower in the DDDRP+MVP arm for all AT/AF durations, in particular, ERAF followed AT/AF longer than 3 hours in 53% cases in Control DDDR, in 51% cases in MVP, and in 39% cases in DDDRP+MVP (P MVP, and 70% in DDDRP+MVP (P MVP, DDDRP+MVP reduces ERAF and favors LAD reduction, suggesting that atrial antitachycardia pacing may reverse electrical and mechanical remodeling. Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  7. Influence of non-steady state during isoglycemic hyperinsulinemic clamp in hypertension. A LIFE substudy

    Olsen, M H; Andersen, U B; Wachtell, K

    1999-01-01

    We wanted to investigate whether time to steady state was reached within 2 h of insulin infusion during isoglycemic hyperinsulinemic clamp, comparing the glucose uptake index (M/IG) with Bergman's insulin sensitivity index (Sip). We performed a 2-h oral glucose tolerance test and a 3-h isoglycemic....... Because the 2-h M/IG correlated strongly with the 3-h Sip with relatively narrow limits of agreement, it is a good measure of insulin sensitivity. However, a 2-h clamp results in lower insulin sensitivity values in elderly, hypertensive patients due to the fact that steady state is not reached...

  8. Informed cytology for triaging HPV-positive women: substudy nested in the NTCC randomized controlled trial.

    Bergeron, Christine; Giorgi-Rossi, Paolo; Cas, Frederic; Schiboni, Maria Luisa; Ghiringhello, Bruno; Dalla Palma, Paolo; Minucci, Daria; Rosso, Stefano; Zorzi, Manuel; Naldoni, Carlo; Segnan, Nereo; Confortini, Massimo; Ronco, Guglielmo

    2015-02-01

    Human papillomavirus (HPV)-based screening needs triage. In most randomized controlled trials (RCTs) on HPV testing with cytological triage, cytology interpretation has been blind to HPV status. Women age 25 to 60 years enrolled in the New Technology in Cervical Cancer (NTCC) RCT comparing HPV testing with cytology were referred to colposcopy if HPV positive and, if no cervical intraepithelial neoplasia (CIN) was detected, followed up until HPV negativity. Cytological slides taken at the first colposcopy were retrieved and independently interpreted by an external laboratory, which was only aware of patients' HPV positivity. Sensitivity, specificity, and positive (PPV) and negative (NPV) predictive values were computed for histologically proven CIN2+ with HPV status-informed cytology for women with a determination of atypical squamous cells of undetermined significance (ASCUS) or more severe. All statistical tests were two-sided. Among HPV-positive women, informed cytology had cross-sectional sensitivity, specificity, PPV and 1-NPV for CIN2+ of 85.6% (95% confidence interval [CI] = 76.6 to 92.1), 65.9% (95% CI = 63.1 to 68.6), 16.2% (95% CI = 13.0 to 19.8), and 1.7 (95% CI = 0.9 to 2.8), respectively. Cytology was also associated with subsequent risk of newly diagnosed CIN2+ and CIN3+. The cross-sectional relative sensitivity for CIN2+ vs blind cytology obtained by referring to colposcopy and following up only HPV positive women who had HPV status-informed cytology greater than or equal to ASCUS was 1.58 (95% CI = 1.22 to 2.01), while the corresponding relative referral to colposcopy was 0.95 (95% CI = 0.86 to 1.04). Cytology informed of HPV positivity is more sensitive than blind cytology and could allow longer intervals before retesting HPV-positive, cytology-negative women. © The Author 2015. Published by Oxford University Press.

  9. Myocardium at risk assessed by electrocardiographic scores and cardiovascular magnetic resonance - a MITOCARE substudy

    Sejersten, Maria; Fakhri, Yama; Pape, Marianne

    2017-01-01

    Introduction The myocardium at risk (MaR) represents the quantitative ischemic area destined to myocardial infarction (MI) if no reperfusion therapy is initiated. Different ECG scores for MaR have been developed, but there is no consensus as to which should be preferred. Objective Comparisons...... of ECG scores and Cardiac Magnetic Resonance (CMR) for determining MaR. Methods MaR was determined by 3 different ECG scores, and by CMR in ST-segment elevation MI (STEMI) patients from the MITOCARE cardioprotection trial. The Aldrich score (AL) is based on the number of leads with ST-elevation...... for anterior MI and the sum of ST-segment elevation for inferior MI on the admission ECG. The van Hellemond score (VH) considers both the ischemic and infarcted component of the MaR by adding the AL and the QRS score, which is an estimate of final infarct size. The Hasche score is based on the maximal possible...

  10. Dexamethasone for the prevention of postpericardiotomy syndrome: A DExamethasone for Cardiac Surgery substudy

    Bunge, Jeroen J. H.; van Osch, Dirk; Dieleman, Jan M.; Jacob, Kirolos A.; Kluin, Jolanda; van Dijk, Diederik; Nathoe, Hendrik M.; Bredée, Jaap J.; Buhre, Wolfgang F.; van Herwerden, Lex A.; Kalkman, Cor J.; van Klarenbosch, Jan; Moons, Karel G.; Numan, Sandra C.; Ottens, Thomas H.; Roes, Kit C.; Sauer, Anne-Mette C.; Slooter, Arjen J.; Nierich, Arno P.; Ennema, Jacob J.; Rosseel, Peter M.; van der Meer, Nardo J.; van der Maaten, Joost M.; Cernak, Vlado; Hofland, Jan; van Thiel, Robert J.; Diephuis, Jan C.; Schepp, Ronald M.; Haenen, Jo; de Lange, Fellery; Boer, Christa; de Jong, Jan R.; Tijssen, Jan G.

    2014-01-01

    The postpericardiotomy syndrome (PPS) is a common complication following cardiac surgery. The pathophysiology remains unclear, although evidence exists that surgical trauma and the use of cardiopulmonary bypass provoke an immune response leading to PPS. We hypothesized that an intraoperative dose of

  11. Impact of statins in microalbuminuric subjects with the metabolic syndrome : a substudy of the PREVEND Intervention Trial

    Geluk, CA; Asselbergs, FW; Hillege, HL; Bakker, SJL; de Jong, PE; Zijlstra, F; van Gilst, WH

    Aims Microalbuminuria frequently clusters with the metabolic syndrome and may identify subjects at increased coronary risk. Statin treatment may reduce the incidence of major adverse cardiac events in subjects with the metabolic syndrome, but evidence is limited. We evaluated the impact of

  12. Report of the substudy assessing the impact of neurocognitive function on quality of life 5 years after cardiac surgery.

    Newman, M F; Grocott, H P; Mathew, J P; White, W D; Landolfo, K; Reves, J G; Laskowitz, D T; Mark, D B; Blumenthal, J A

    2001-12-01

    The importance of perioperative cognitive decline has long been debated. We recently demonstrated a significant correlation between perioperative cognitive decline and long-term cognitive dysfunction. Despite this association, some still question the importance of these changes in cognitive function to the quality of life of patients and their families. The purpose of our investigation was to determine the association between cognitive dysfunction and long-term quality of life after cardiac surgery. After institutional review board approval and patient informed consent, 261 patients undergoing cardiac surgery with cardiopulmonary bypass were enrolled and followed for 5 years. Cognitive function was measured with a battery of tests at baseline, discharge, and 6 weeks and 5 years postoperatively. Quality of life was assessed with well-validated, standardized assessments at the 5-year end point. Our results demonstrate significant correlations between cognitive function and quality of life in patients after cardiac surgery. Lower 5-year overall cognitive function scores were associated with lower general health and a less productive working status. Multivariable logistic and linear regression controlling for age, sex, education, and diabetes confirmed this strong association in the majority of areas of quality of life. Five years after cardiac surgery, there is a strong relationship between neurocognitive functioning and quality of life. This has important social and financial implications for preoperative evaluation and postoperative care of patients undergoing cardiac surgery.

  13. Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study.

    Williams, Barbara F; French, John K; White, Harvey D

    2003-03-15

    Anxiety, fear, pain, and treatment with morphine might compromise the ability of patients to comprehend information about, and give informed consent for, participation in clinical trials. We aimed to assess whether patients with acute myocardial infarction could understand written and verbal information and whether they were competent to give autonomous informed consent to participate in a clinical trial. We prospectively studied 399 patients with acute myocardial infarction in 16 hospitals in New Zealand and Australia who were eligible for participation in the Hirulog and Early Reperfusion or Occlusion (HERO)-2 trial. We assessed readability of patient information sheets, patients' educational status, their views of the consent process, comprehension of verbal and written information, and competence to give consent. The patient information sheet needed a year 13 (age 18) educational level for comprehension, although only 75 of 345 patients (22%) had been educated beyond secondary school. Only 63 of 346 (18%) read the patient information sheet before giving or refusing consent to participate. Patients who gave consent were more likely to report good or partial comprehension of the information provided than were those who refused consent (272 [89%] vs 14 [70%], respectively; p=0.009). In an assessment of competence to make an autonomous decision, 75 of 145 (52%) were ranked at the lowest grade and 26 (18%) were not competent to consent. Although the consent process for HERO-2 met regulatory requirements for clinical trials, it was inappropriate for the needs of most patients. The patients' comprehension of the information provided and their competence to autonomously give consent was less than optimum.

  14. Pressure ulcers in critically ill patients - Preventable by non-sedation? A substudy of the NONSEDA-trial

    Nedergaard, Helene K.; Haberlandt, Trine; Toft, Palle

    2018-01-01

    . Patients with pressure ulcers in the two groups were comparable with regards to baseline data. There were 44 ulcers in 32 patients in the sedated group and 31 ulcers in 25 patients in the non-sedated group (p = 0.08). 64% of the ulcers in sedated patients were located on sacrum and heels, whereas 68...... mainly had ulcers on the sacrum and heels....

  15. Cardiac Resynchronization in Different Age Groups: A MADIT-CRT Long-Term Follow-Up Substudy.

    Thomas, Sabu; Moss, Arthur J; Zareba, Wojciech; McNitt, Scott; Barsheshet, Alon; Klein, Helmut; Goldenberg, Ilan; Huang, David T; Biton, Yitschak; Kutyifa, Valentina

    2016-02-01

    Cardiac resynchronization with defibrillators (CRT-D) reduces heart failure and mortality compared with defibrillators alone. Whether this applies to all ages is unclear. We assessed the association of age on heart failure and death as a post hoc analysis of the MADIT-CRT follow-up study, in which 1,281 patients with class I/II heart failure (HF) were randomized to CRT-D or implantable cardioverter-defibrillators alone. Different age groups (age groups, there were 399, 651, and 231 patients, respectively. We compared events with the use of a multivariate regression model. CRT-D compared with defibrillators alone significantly reduced the composite of HF or death across all age groups: age groups: age group: RRR = 59%. CRT-D reduced HF events and the composite of mortality or HF events during long-term follow-up in all age groups. CRT-D reduced mortality only in the 60-74 year age group. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. Effects of an isocaloric healthy Nordic diet on ambulatory blood pressure in metabolic syndrome: a randomized SYSDIET sub-study.

    Brader, L; Uusitupa, M; Dragsted, L O; Hermansen, K

    2014-01-01

    Dietary pattern is central in the prevention of hypertension and blood pressure (BP)-related diseases. A diet based on healthy Nordic foods may have a favourable impact on BP. The objective was to clarify whether a Nordic alternative for a healthy food pattern would have beneficial effects on ambulatory BP in subjects with metabolic syndrome (MetS). In total, 37 subjects were randomized to either a healthy Nordic diet or a control diet. A healthy Nordic diet embraced whole grains, rapeseed oil, berries, fruits, vegetables, fish, nuts and low-fat dairy products of Nordic origin. The mean nutrient intake in the Nordic countries formed the control diet, embracing wheat products, dairy fat-based spread and a lower intake of fruits, vegetables and fish. Diets were isoenergetic. Ambulatory BP was monitored and 24-h urine was collected before and after 12 weeks of intervention. After 12 weeks, ambulatory diastolic BP (-4.4 mm Hg; P=0.001) and mean arterial pressure (-4.2 mm Hg; P=0.006) were lowered by the healthy Nordic diet compared with the control diet, whereas changes in ambulatory systolic BP did not differ significantly between diets (-3.5 mm Hg; P=0.122). Heart rate tended to be lower in those on the healthy Nordic diet (P=0.057). Urinary sodium and potassium excretions were unaffected by diets and consequently not associated with the healthy Nordic diet-induced lowering of BP. Consumption of Nordic varieties of health-enhancing foods for 12 weeks decreased diastolic ambulatory BP and mean arterial pressure in subjects with features of MetS during weight-stable condition, suggesting beneficial effects of a healthy Nordic dietary pattern on ambulatory BP.

  17. Prolonged Adaptation to a Low or High Protein Diet Does Not Modulate Basal Muscle Protein Synthesis Rates - A Substudy.

    Hursel, Rick; Martens, Eveline A P; Gonnissen, Hanne K J; Hamer, Henrike M; Senden, Joan M G; van Loon, Luc J C; Westerterp-Plantenga, Margriet S

    2015-01-01

    Based on controlled 36 h experiments a higher dietary protein intake causes a positive protein balance and a negative fat balance. A positive net protein balance may support fat free mass accrual. However, few data are available on the impact of more prolonged changes in habitual protein intake on whole-body protein metabolism and basal muscle protein synthesis rates. To assess changes in whole-body protein turnover and basal muscle protein synthesis rates following 12 weeks of adaptation to a low versus high dietary protein intake. A randomized parallel study was performed in 40 subjects who followed either a high protein (2.4 g protein/kg/d) or low protein (0.4 g protein/kg/d) energy-balanced diet (30/35/35% or 5/60/35% energy from protein/carbohydrate/fat) for a period of 12 weeks. A subgroup of 7 men and 8 women (body mass index: 22.8±2.3 kg/m2, age: 24.3±4.9 y) were selected to evaluate the impact of prolonged adaptation to either a high or low protein intake on whole body protein metabolism and basal muscle protein synthesis rates. After the diet, subjects received continuous infusions with L-[ring-2H5]phenylalanine and L-[ring-2H2]tyrosine in an overnight fasted state, with blood samples and muscle biopsies being collected to assess post-absorptive whole-body protein turnover and muscle protein synthesis rates in vivo in humans. After 12 weeks of intervention, whole-body protein balance in the fasted state was more negative in the high protein treatment when compared with the low protein treatment (-4.1±0.5 vs -2.7±0.6 μmol phenylalanine/kg/h;Pprotein breakdown (43.0±4.4 vs 37.8±3.8 μmol phenylalanine/kg/h;Psynthesis (38.9±4.2 vs 35.1±3.6 μmol phenylalanine/kg/h;Pprotein group. Basal muscle protein synthesis rates were maintained on a low vs high protein diet (0.042±0.01 vs 0.045±0.01%/h;P = 0.620). In the overnight fasted state, adaptation to a low-protein intake (0.4 g/kg/d) does not result in a more negative whole-body protein balance and does not lower basal muscle protein synthesis rates when compared to a high-protein intake. Clinicaltrials.gov NCT01551238.

  18. Long-term treatment with losartan versus atenolol improves insulin sensitivity in hypertension: ICARUS, a LIFE substudy

    Olsen, Michael H; Fossum, Eigil; Høieggen, Aud

    2005-01-01

    Hypertension and insulin resistance might be associated through peripheral vascular hypertrophy/rarefaction which compromises skeletal muscle blood flow and decreases glucose uptake, inducing insulin resistance. We hypothesized that treatment with losartan as compared to atenolol would improve...... insulin sensitivity through regression of peripheral vascular hypertrophy/rarefaction....

  19. Patients' and Health Professionals' Experiences of Using Virtual Reality Technology for Upper Limb Training after Stroke: A Qualitative Substudy.

    Pallesen, Hanne; Andersen, Mette Brændstrup; Hansen, Gunhild Mo; Lundquist, Camilla Biering; Brunner, Iris

    2018-01-01

    In recent years, virtual reality (VR) therapy systems for upper limb training after stroke have been increasingly used in clinical practice. Therapy systems employing VR technology can enhance the intensity of training and can also boost patients' motivation by adding a playful element to therapy. However, reports on user experiences are still scarce. A qualitative investigation of patients' and therapists' perspectives on VR upper limb training. Semistructured face-to-face interviews were conducted with six patients in the final week of the VR intervention. Therapists participated in two focus group interviews after the completion of the intervention. The interviews were analyzed from a phenomenological perspective emphasizing the participants' perceptions and interpretations. Five key themes were identified from the patients' perspectives: (i) motivational factors, (ii) engagement, (iii) perceived improvements, (iv) individualization, and (v) device malfunction. The health professionals described the same themes as the patients but less positively, emphasizing negative technical challenges. Patients and therapists mainly valued the intensive and motivational character of VR training. The playful nature of the training appeared to have a significant influence on the patients' moods and engagement and seemed to promote a "gung-ho" spirit, so they felt that they could perform more repetitions.

  20. Addressing ethical challenges in the Genetics Substudy of the National Eye Survey of Trinidad and Tobago (GSNESTT

    Allana N. Roach

    2016-06-01

    Conclusion: This paper outlines an ethical framework for the conduct of population-based genetics and genomics research in Trinidad and Tobago; highlights common issues arising in the field and strategies to address these.

  1. Prolonged Adaptation to a Low or High Protein Diet Does Not Modulate Basal Muscle Protein Synthesis Rates - A Substudy.

    Rick Hursel

    Full Text Available Based on controlled 36 h experiments a higher dietary protein intake causes a positive protein balance and a negative fat balance. A positive net protein balance may support fat free mass accrual. However, few data are available on the impact of more prolonged changes in habitual protein intake on whole-body protein metabolism and basal muscle protein synthesis rates.To assess changes in whole-body protein turnover and basal muscle protein synthesis rates following 12 weeks of adaptation to a low versus high dietary protein intake.A randomized parallel study was performed in 40 subjects who followed either a high protein (2.4 g protein/kg/d or low protein (0.4 g protein/kg/d energy-balanced diet (30/35/35% or 5/60/35% energy from protein/carbohydrate/fat for a period of 12 weeks. A subgroup of 7 men and 8 women (body mass index: 22.8±2.3 kg/m2, age: 24.3±4.9 y were selected to evaluate the impact of prolonged adaptation to either a high or low protein intake on whole body protein metabolism and basal muscle protein synthesis rates. After the diet, subjects received continuous infusions with L-[ring-2H5]phenylalanine and L-[ring-2H2]tyrosine in an overnight fasted state, with blood samples and muscle biopsies being collected to assess post-absorptive whole-body protein turnover and muscle protein synthesis rates in vivo in humans.After 12 weeks of intervention, whole-body protein balance in the fasted state was more negative in the high protein treatment when compared with the low protein treatment (-4.1±0.5 vs -2.7±0.6 μmol phenylalanine/kg/h;P<0.001. Whole-body protein breakdown (43.0±4.4 vs 37.8±3.8 μmol phenylalanine/kg/h;P<0.03, synthesis (38.9±4.2 vs 35.1±3.6 μmol phenylalanine/kg/h;P<0.01 and phenylalanine hydroxylation rates (4.1±0.6 vs 2.7±0.6 μmol phenylalanine/kg/h;P<0.001 were significantly higher in the high vs low protein group. Basal muscle protein synthesis rates were maintained on a low vs high protein diet (0.042±0.01 vs 0.045±0.01%/h;P = 0.620.In the overnight fasted state, adaptation to a low-protein intake (0.4 g/kg/d does not result in a more negative whole-body protein balance and does not lower basal muscle protein synthesis rates when compared to a high-protein intake.Clinicaltrials.gov NCT01551238.

  2. Impact of diagnostic ECG to wire delay in STEMI patients treated with primary PCI - a DANAMI-3 substudy

    Nepper-Christensen, Lars; Lønborg, Jacob; Høfsten, Dan Eik

    2018-01-01

    AIMS: We evaluated the impact of delay from diagnostic pre-hospital electrocardiogram (ECG) to wiring of the infarct related vessel (ECG-to-wire) >120 minutes on cardiovascular magnetic resonance (CMR) markers of reperfusion success and clinical outcome in patients with ST-segment elevation...... myocardial infarction (STEMI). METHODS AND RESULTS: We included 1492 patients in the analyses of clinical outcome. CMR was performed in 748 patients to evaluate infarct size and myocardial salvage. In total, 304 patients (20%) had ECG-to-wire >120 minutes, which was associated with larger acute infarct size...... (18% [interquartile range (IQR), 10-28] vs. 15% [8-24]; p=0.022) and smaller myocardial salvage (0.42 [IQR 0.28-0.57] vs. 0.50 [IQR 0.34-0.70]; p=0.002). However, 33% of the patients with ECG-to-wire >120 minutes still had a substantial myocardial salvage of more than 0.50. In a multivariable analysis...

  3. Impact of hypertension on left ventricular structure in patients with asymptomatic aortic valve stenosis (a SEAS substudy)

    Rieck, Ashild E; Cramariuc, Dana; Staal, Eva M

    2010-01-01

    Both hypertension and aortic valve stenosis induce left ventricular hypertrophy. However, less is known about the influence of concomitant hypertension on left ventricular structure in patients with aortic valve stenosis.......Both hypertension and aortic valve stenosis induce left ventricular hypertrophy. However, less is known about the influence of concomitant hypertension on left ventricular structure in patients with aortic valve stenosis....

  4. Patients’ and Health Professionals’ Experiences of Using Virtual Reality Technology for Upper Limb Training after Stroke: A Qualitative Substudy

    Hanne Pallesen

    2018-01-01

    Full Text Available Background. In recent years, virtual reality (VR therapy systems for upper limb training after stroke have been increasingly used in clinical practice. Therapy systems employing VR technology can enhance the intensity of training and can also boost patients’ motivation by adding a playful element to therapy. However, reports on user experiences are still scarce. Methods. A qualitative investigation of patients’ and therapists’ perspectives on VR upper limb training. Semistructured face-to-face interviews were conducted with six patients in the final week of the VR intervention. Therapists participated in two focus group interviews after the completion of the intervention. The interviews were analyzed from a phenomenological perspective emphasizing the participants’ perceptions and interpretations. Results. Five key themes were identified from the patients’ perspectives: (i motivational factors, (ii engagement, (iii perceived improvements, (iv individualization, and (v device malfunction. The health professionals described the same themes as the patients but less positively, emphasizing negative technical challenges. Conclusion. Patients and therapists mainly valued the intensive and motivational character of VR training. The playful nature of the training appeared to have a significant influence on the patients’ moods and engagement and seemed to promote a “gung-ho” spirit, so they felt that they could perform more repetitions.

  5. Accelerated collagen turnover in women with angina pectoris without obstructive coronary artery disease: An iPOWER substudy.

    Nielsen, Signe H; Mygind, Naja D; Michelsen, Marie M; Bechsgaard, Daria F; Suhrs, Hannah E; Genovese, Federica; Nielsen, Henning B; Brix, Susanne; Karsdal, Morten; Prescott, Eva; Kastrup, Jens

    2018-05-01

    Aim Collagens are major cardiac extracellular matrix components, known to be actively remodelled and accumulated during diffuse myocardial fibrosis. We evaluated whether accelerated collagen turnover described by neo-epitope biomarkers reflecting collagen formation and degradation separates patients with diffuse myocardial fibrosis from asymptomatic controls. Methods and results Seventy-one women with angina pectoris without significant coronary artery disease assessed by invasive coronary angiogram were included. Competitive enzyme-linked immunosorbent assays (ELISAs) measuring circulating protein fragments in serum assessed the formation and degradation of collagen type III (Pro-C3, C3M and C3C), IV (P4NP7S and C4M), V (Pro-C5 and C5M) and VI (Pro-C6 and C6M), and degradation of collagen type I (C1M). Serum samples from 32 age-matched asymptomatic women were included as controls. Symptomatic women presented significantly elevated levels of Pro-C6, C3C, C3M, C4M and C8-C ( p angina pectoris, but without significant obstructive coronary artery disease, showed an imbalanced collagen turnover compared to asymptomatic controls. The examined biomarkers are tools to monitor active collagen remodelling in patients with angina pectoris, in risk of developing myocardial fibrosis.

  6. Accelerated collagen turnover in women with angina pectoris without obstructive coronary artery disease: An iPOWER substudy

    Nielsen, Signe H; Mygind, Naja D; Michelsen, Marie M

    2018-01-01

    patients with diffuse myocardial fibrosis from asymptomatic controls. Methods and results: Seventy-one women with angina pectoris without significant coronary artery disease assessed by invasive coronary angiogram were included. Competitive enzyme-linked immunosorbent assays (ELISAs) measuring circulating....... Cardiac magnetic resonance T1 mapping was performed to determine extracellular volume fraction and thus diffuse myocardial fibrosis. A significant association was identified between C5M and extracellular volume fraction by cardiac magnetic resonance (p = 0.01). Conclusion: Women with angina pectoris......, but without significant obstructive coronary artery disease, showed an imbalanced collagen turnover compared to asymptomatic controls. The examined biomarkers are tools to monitor active collagen remodelling in patients with angina pectoris, in risk of developing myocardial fibrosis....

  7. Importance of Active Participation in Obesity Management Through Mobile Health Care Programs: Substudy of a Randomized Controlled Trial.

    Oh, Bumjo; Yi, Ga-Hye; Han, Min Kyu; Kim, Jong Seung; Lee, Chang Hee; Cho, Belong; Kang, Hee Cheol

    2018-01-03

    Due to the prevalence of the westernized dietary pattern and lack of physical activity, the numbers of overweight or obese individuals are increasing, resulting in a growing health burden because of various related diseases. A lifestyle modification approach has additional advantages compared with pharmacological therapies or bariatric surgery. In our randomized controlled trial conducted in 2015, we successfully used a ubiquitous health care (SmartCare) service for patients with metabolic syndrome to achieve a significant weight loss effect. Various useful apps have been developed for the SmartCare Service, which involves using a mobile phone to manage chronic diseases, minimizing time and space restrictions. Many studies have demonstrated weight loss effects using a SmartCare service, but limited data are available regarding the effect of active participation in relation to weight loss. We aimed to assess the weight loss effect achieved after using the SmartCare service in terms of adherence and participation. We divided the intervention group of the previous study according to participation level, and analyzed whether there was a significant difference in the outcome. We classified participants into 3 groups according to their adherence. Within the intervention group using the SmartCare service, the active group comprised those transmitting anthropometric measurement data using a mobile phone 3 or more times per week or who had a health consultation 5 or more times during a 24-week period. The passive group comprised those who did not adhere to these levels of engagement. The control group comprised those who did not use the SmartCare service. We compared changes in body weight, body mass index (BMI), body fat percentage, waist circumference, and lipid profile among the 3 groups. We identified 422 participants and analyzed 405, excluding 17 who were missing necessary data for analysis. The active group consisted of 116 participants, compared with 80 in the passive group and 209 in the control group (without SmartCare service). There was a statistically significant difference in improvements to body weight, BMI, body fat percentage, and waist circumference among active participants compared with less active participants and the control group (Pservice, encouraging active participation is important. Clinicaltrials.gov NCT01344811; https://clinicaltrials.gov/ct2/show/NCT01344811 (Archived by WebCite at http://www.webcitation.org/6alT2MmIB). ©Bumjo Oh, Ga-Hye Yi, Min Kyu Han, Jong Seung Kim, Chang Hee Lee, Belong Cho, Hee Cheol Kang. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 03.01.2018.

  8. Reproductive factors, lifestyle and dietary habits among pregnant women in Greenland: The ACCEPT sub-study 2013-2015.

    Terkelsen, Anne Seneca; Long, Manhai; Hounsgaard, Lise; Bonefeld-Jørgensen, Eva Cecilie

    2018-03-01

    During past decades the formerly active lifestyle in Greenland has become sedentary, and the intake of traditional food has gradually been replaced with imported food. These lifestyle and dietary habits may affect pregnant women. To describe age and regional differences in reproductive factors, lifestyle and diet among Greenlandic pregnant women in their first trimester. A cross-sectional study during 2013-2015 including 373 pregnant women was conducted in five Greenlandic regions (West, Disko Bay, South, North and East). Interview-based questionnaires on reproductive factors, lifestyle and dietary habits were compared in relation to two age groups (median age ≤28 years and >28 years). In total, 72.4% were Inuit, 46.6% had BMI >25.0 kg/m 2 , 29.0% were smoking during pregnancy and 54.6% had used hashish. BMI, educational level, personal income, previous pregnancies and planned breastfeeding period were significantly higher in the age group >28 years of age compared to the age group ≤28 years of age. In region Disko Bay, 90.9% were Inuit, in region South more had a university degree (37.9%) and region East had the highest number of previous pregnancies, the highest number of smokers during pregnancy and the most frequent intake of sauce with hot meals and fast-food. Overall a high BMI and a high smoking frequency were found. Age differences were found for BMI and planned breastfeeding period, while regional differences were found for smoking and intake of sauce with hot meals and fast-food. Future recommendations aimed at pregnant women in Greenland should focus on these health issues.

  9. Value of exercise echocardiography in heart failure with preserved ejection fraction: a substudy from the KaRen study.

    Donal, Erwan; Lund, Lars H; Oger, Emmanuel; Reynaud, Amélie; Schnell, Frédéric; Persson, Hans; Drouet, Elodie; Linde, Cecilia; Daubert, Claude

    2016-01-01

    KaRen is a multicentre study designed to characterize and follow patients with heart failure and preserved ejection fraction (HFpEF). In a subgroup of patients with clinical signs of congestion but left ventricular ejection fraction (LVEF) >45%, we sought to describe and analyse the potential prognostic value of echocardiographic parameters recorded not only at rest but also during a submaximal exercise stress echocardiography. Exercise-induced changes in echo parameters might improve our ability to characterize HFpEF patients. Patients were prospectively recruited in a single tertiary centre following an acute HF episode with NT-pro-BNP >300 pg/mL (BNP > 100 pg/mL) and LVEF > 45% and reassessed by exercise echo-Doppler after 4-8 weeks of dedicated treatment. Image acquisitions were standardized, and analysis made at end of follow-up blinded to patients' clinical status and outcome. In total, 60 patients having standardized echocardiographic acquisitions were included in the analysis. Twenty-six patients (43%) died or were hospitalized for HF (primary outcome). The mean ± SD workload was 45 ± 14 watts (W). Mean ± SD resting LVEF and LV global longitudinal strain was 57.6 ± 9.5% and -14.5 ± 4.2%, respectively. Mean ± SD resting E/e' was 11.3 ± 4.7 and 13.1 ± 5.3 in those patients who did not and those who did experience the primary outcome, respectively (P = 0.03). Tricuspid regurgitation (TR) peak velocity during exercise were 3.3 ± 0.5 and 3.7 ± 0.5 m/s (P = 0.01). Exercise TR was independently associated with HF-hospitalization or death after adjustment on baseline clinical and biological characteristics. Exercise echocardiography may contribute to identify HFpEF patients and especially high-risk ones. Our study suggested a prognostic value of TR recorded during an exercise. That was demonstrated independently of the value of resting E/e'. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  10. TDF and quantitative ultrasound bone quality in African patients on second line ART, ANRS 12169 2LADY sub-study.

    Kabore, Firmin Nongodo; Eymard-Duvernay, Sabrina; Zoungrana, Jacques; Badiou, Stéphanie; Bado, Guillaume; Héma, Arsène; Diouf, Assane; Delaporte, Eric; Koulla-Shiro, Sinata; Ciaffi, Laura; Cournil, Amandine

    2017-01-01

    Bone demineralization, which leads to osteoporosis and increased fracture risk, is a common metabolic disorder in HIV-infected individuals. In this study, we aimed to assess the change in bone quality using quantitative ultrasound (QUS) over 96 weeks of follow-up after initiation of second-line treatment, and to identify factors associated with change in bone quality. In a randomized trial (ANRS 12169), TDF and PI-naïve participants failing standard first-line treatment, from Burkina Faso, Cameroon, and Senegal were randomized to receive either TDF/FTC/LPVr, ABC/ddI/LPVr or TDF/FTC/DRVr. Their bone quality was assessed using calcaneal QUS at baseline and every 24 weeks until week 96. Stiffness index (SI) was used to measure bone quality. Out of 228 participants, 168 (74%) were women. At baseline, median age was 37 years (IQR: 33-46 years) and median T-CD4 count was 199 cells/μl (IQR: 113-319 cells/μl). The median duration of first-line antiretroviral treatment (ART) was 52 months (IQR: 36-72 months) and the median baseline SI was 101 (IQR: 87-116). In multivariable analysis, factors associated with baseline SI were sex (β = -10.8 [-18.1,-3.5] for women), age (β = -8.7 [-12.4,-5.1] per 10 years), body mass index (BMI) (β = +0.8 [0.1,1.5] per unit of BMI), and study site (β = +12.8 [6.5,19.1] for Cameroon). After 96 weeks of second-line therapy, a reduction of 7.1% in mean SI was observed, as compared with baseline. Factors associated with SI during the follow-up were similar to those found at baseline. Exposure to TDF was not associated with a greater loss of bone quality over time. Bone quality decreased after second-line ART initiation in African patients independently of TDF exposure. Factors associated with bone quality include age, sex, baseline BMI, study site, and duration of follow-up.

  11. Effects of golden hour thrombolysis: a Prehospital Acute Neurological Treatment and Optimization of Medical Care in Stroke (PHANTOM-S) substudy.

    Ebinger, Martin; Kunz, Alexander; Wendt, Matthias; Rozanski, Michal; Winter, Benjamin; Waldschmidt, Carolin; Weber, Joachim; Villringer, Kersten; Fiebach, Jochen B; Audebert, Heinrich J

    2015-01-01

    The effectiveness of intravenous thrombolysis in acute ischemic stroke is time dependent. The effects are likely to be highest if the time from symptom onset to treatment is within 60 minutes, termed the golden hour. To determine the achievable rate of golden hour thrombolysis in prehospital care and its effect on outcome. The prospective controlled Prehospital Acute Neurological Treatment and Optimization of Medical Care in Stroke study was conducted in Berlin, Germany, within an established infrastructure for stroke care. Weeks were randomized according to the availability of a specialized ambulance (stroke emergency mobile unit (STEMO) from May 1, 2011, through January 31, 2013. We included 6182 consecutive adult patients for whom a stroke dispatch (44.1% male; mean [SD] age, 73.9 [15.0] years) or regular care (45.0% male; mean [SD] age, 74.2 [14.9] years) were included. The STEMO was deployed when the dispatchers suspected an acute stroke during emergency calls. If STEMO was not available (during control weeks, when the unit was already in operation, or during maintenance), patients received conventional care. The STEMO is equipped with a computed tomographic scanner plus a point-of-care laboratory and telemedicine connection. The unit is staffed with a neurologist trained in emergency medicine, a paramedic, and a technician. Thrombolysis was started in STEMO if a stroke was confirmed and no contraindication was found. Rates of golden hour thrombolysis, 7- and 90-day mortality, secondary intracerebral hemorrhage, and discharge home. Thrombolysis rates in ischemic stroke were 200 of 614 patients (32.6%) when STEMO was deployed and 330 of 1497 patients (22.0%) when conventional care was administered (P golden hour thrombolysis was 6-fold higher after STEMO deployment (62 of 200 patients [31.0%] vs 16 of 330 [4.9%]; P golden hour thrombolysis had no higher risks for 7- or 90-day mortality (adjusted odds ratios, 0.38 [95% CI, 0.09-1.70]; P = .21 and 0.69 [95% CI, 0.32-1.53]; P = .36) and were more likely to be discharged home (adjusted odds ratio, 1.93 [95% CI, 1.09-3.41]; P = .02). The use of STEMO increases the percentage of patients receiving thrombolysis within the golden hour. Golden hour thrombolysis entails no risk to the patients' safety and is associated with better short-term outcomes. clinicaltrials.gov Identifier: NCT01382862.

  12. Diphtheria, tetanus, poliomyelitis, yellow fever and hepatitis B seroprevalence among HIV1-infected migrants. Results from the ANRS VIHVO vaccine sub-study.

    Mullaert, Jimmy; Abgrall, Sophie; Lele, Nathalie; Batteux, Frederic; Slama, Lilia Ben; Meritet, Jean-Francois; Lebon, Pierre; Bouchaud, Olivier; Grabar, Sophie; Launay, Odile

    2015-09-11

    Few data are available on the seroprotection status of HIV1-infected patients with respect to vaccine-preventable diseases. To describe, in a population of HIV1-infected migrants on stable, effective ART therapy, the seroprevalence of diphtheria, poliomyelitis, tetanus, yellow fever antibodies and serostatus for hepatitis B, and to identify factors associated with seroprotection. Vaccine responses against diphtheria, tetanus, poliomyelitis and yellow fever were also studied. Sub-Saharan African patients participating in the ANRS-VIHVO cohort were enrolled prior to travel to their countries of origin. Serologic analyses were performed in a central laboratory before and after the trip. Univariate and multivariate logistic regression was used to identify factors associated with initial seroprotection. 250 patients (99 men and 151 women) were included in the seroprevalence study. Median age was 45 years (IQR 39-52), median CD4 cell count was 440/μL (IQR 336-571), and 237 patients (95%) had undetectable HIV1 viral load. The initial seroprevalence rates were 69.0% (95%CI 63.2-74.7) for diphtheria, 70.7% (95%CI 65.0-76.3) for tetanus, and 85.9% (95%CI 81.6-90.2) for yellow fever. Only 64.4% (95%CI 58.5-70.3) of patients had protective antibody titers against all three poliomyelitis vaccine strains before travel. No serological markers of hepatitis B were found in 18.6% of patients (95%CI 13.7-23.3). Patient declaration of prior vaccination was the only factor consistently associated with initial seroprotection. We found a low prevalence of seroprotection against diphtheria, poliomyelitis, tetanus and hepatitis B. HIV infected migrants living in France and traveling to their native countries need to have their vaccine schedule completed. Copyright © 2015 Elsevier Ltd. All rights reserved.

  13. Outcome of Sirolimus-Eluting Versus Zotarolimus-Eluting Coronary Stent Implantation in Patients With and Without Diabetes Mellitus (a SORT OUT III Substudy)

    Maeng, Michael; Jensen, Lisette O; Tilsted, Hans-Henrik

    2011-01-01

    Diabetes is associated with an increased risk of major adverse cardiac events after percutaneous coronary intervention. We compared clinical outcomes in patients with and without diabetes mellitus treated with the second-generation Endeavor zotarolimus-eluting stent (ZES) or the first...... cardiac events defined as a composite of cardiac death, myocardial infarction, or target vessel revascularization. Secondary end points included these individual end points plus all-cause mortality and target lesion revascularization. In diabetic patients, use of ZES compared to SES was associated.......90 to 13.1), and target lesion revascularization (12.4% vs 1.2%, hazard ratio 11.0, 95% confidence interval 2.59 to 47.1). In patients without diabetes differences in absolute risk decrease were smaller but similarly favored SES. In conclusion, implantation of ZESs compared to SESs is associated...

  14. Diastolic dysfunction predicts new-onset atrial fibrillation and cardiovascular events in patients with acute myocardial infarction and depressed left ventricular systolic function: a CARISMA substudy

    Jons, Christian; Joergensen, Rikke Moerch; Hassager, Christian

    2010-01-01

    The aim of this study was to investigate the association between diastolic dysfunction and long-term occurrence of new-onset atrial fibrillation (AF) and cardiac events in patients with acute myocardial infarction (AMI) and left ventricular (LV) systolic dysfunction.......The aim of this study was to investigate the association between diastolic dysfunction and long-term occurrence of new-onset atrial fibrillation (AF) and cardiac events in patients with acute myocardial infarction (AMI) and left ventricular (LV) systolic dysfunction....

  15. The incidence and prognostic significance of new-onset atrial fibrillation in patients with acute myocardial infarction and left ventricular systolic dysfunction: a CARISMA substudy

    Jons, Christian; Jacobsen, Uffe G; Joergensen, Rikke Moerch

    2011-01-01

    The incidence and risk associated with new-onset atrial fibrillation (AF) occurring after discharge in patients with acute myocardial infarction (MI) remains unknown.......The incidence and risk associated with new-onset atrial fibrillation (AF) occurring after discharge in patients with acute myocardial infarction (MI) remains unknown....

  16. Autonomic dysfunction and new-onset atrial fibrillation in patients with left ventricular systolic dysfunction after acute myocardial infarction: a CARISMA substudy

    Jøns, Christian; Raatikainen, Pekka; Gang, Uffe J

    2010-01-01

    Atrial fibrillation (AF) increases morbidity and mortality in patients with previous myocardial infarction and left ventricular systolic dysfunction. The purpose of this study was to identify patients with a high risk for new-onset AF in this population using invasive and noninvasive...

  17. Brazilian multicenter study on efficacy and tolerability of trandolapril in mild-to-moderate essential arterial hypertension. EMBATHE substudy with ambulatory blood pressure monitoring

    Osvaldo Kohlmann Jr

    1999-05-01

    Full Text Available OBJECTIVE: A double-blind, placebo-controlled multicenter study involving 34 centers from different Brazilian regions was performed to evaluate the antihypertensive efficacy and tolerability of trandolapril, an angiotensin I converting enzyme inhibitor, in the treatment of mild-to-moderate systemic arterial hypertension. METHODS: Of 262 patients enrolled in this study, 127 were treated with trandolapril 2 mg/day for 8 consecutive weeks, and the remaining 135 patients received placebo for the same period of time. Reduction in blood pressure (BP and the occurrence of adverse events during this period were evaluated in both groups. RESULTS: Significant reductions in both systolic and diastolic pressures were observed in patients treated with trandolapril when compared with those on placebo. Antihypertensive efficacy was achieved in 57.5% of the patients on trandolapril and in 42% of these normal values of BP were obtained. The efficacy of trandolapril was similar in all centers, regardless of the area of the country. In a subset of 30 patients who underwent ABPM, responders showed a significant hypotensive effect to trandolapril throughout the 24 hour day. The adverse event profile was similar in both trandolapril and placebo groups. CONCLUSION: Our results demonstrate, for the first time in a large group of hypertensive patients from different regions in Brazil, good efficacy and tolerability of trandolapril during treatment of mild-to-moderate essential systemic hypertension.

  18. High Density Lipoprotein Structural Changes and Drug Response in Lipidomic Profiles following the Long-Term Fenofibrate Therapy in the FIELD Substudy

    Yetukuri, L.; Huopaniemi, I.; Koivuniemi, A.

    2011-01-01

    In a recent FIELD study the fenofibrate therapy surprisingly failed to achieve significant benefit over placebo in the primary endpoint of coronary heart disease events. Increased levels of atherogenic homocysteine were observed in some patients assigned to fenofibrate therapy but the molecular...... of lysophosphatidylcholines and increase of sphingomyelins. Ethanolamine plasmalogens were diminished only in a subgroup of fenofibrate-treated patients with elevated homocysteine levels. Finally we performed molecular dynamics simulations to qualitatively reconstitute HDL particles in silico. We found that increased number...

  19. Cardiopulmonary bypass and intra-aortic balloon pump use is associated with higher short and long term mortality after transcatheter aortic valve replacement: a PARTNER trial substudy.

    Shreenivas, Satya S; Lilly, Scott M; Szeto, Wilson Y; Desai, Nimesh; Anwaruddin, Saif; Bavaria, Joseph E; Hudock, Kristin M; Thourani, Vinod H; Makkar, Raj; Pichard, Augusto; Webb, John; Dewey, Todd; Kapadia, Samir; Suri, Rakesh M; Xu, Ke; Leon, Martin B; Herrmann, Howard C

    2015-08-01

    Transcatheter aortic valve replacement (TAVR) with the balloon-expandable Sapien transcatheter heart valve improves survival compared to standard therapy in patients with severe aortic stenosis (AS) and is noninferior to surgical aortic valve replacement (AVR) in patients at high operative risk. Nonetheless, a significant proportion of patients may require pre-emptive or emergent support with cardiopulmonary bypass (CPB) and/or intra-aortic balloon pump (IABP) during TAVR due to pre-existing comorbid conditions or as a result of procedural complications. We hypothesized that patients who required CPB or IABP would have increased periprocedural complications and reduced long-term survival. In addition, we sought to determine whether preprocedural variables could predict the need for CPB and IABP. The study population included 2,525 patients in the PARTNER Trial (Cohort A and B) and the continuing access registry (CAR). Patients that received CPB or IABP were compared to patients that did not receive either, and then further divided into those that received support pre-TAVR and those that were placed on support emergently. One-hundred sixty-three patients (6.5%) were placed on CPB and/or IABP. The use of CPB or IABP was associated with higher 1 year mortality (49.1% vs. 21.6%, P non-CPB/IABP cases (53.3% and 40.3% vs. 21.6%, P < 0.001). These findings indicate that CPB and IABP use in TAVR portends a poor prognosis and its utilization, particularly in the setting of pre-emptive use, needs reconsideration. © 2015 Wiley Periodicals, Inc.

  20. Maximal exercise capacity is related to cardiovascular structure in patients with longstanding hypertension. A LIFE substudy. Losartan Intervention For Endpoint-Reduction in Hypertension

    Olsen, M H; Wachtell, K; Hermann, K L

    2001-01-01

    BACKGROUND: Cardiovascular hypertrophy and remodeling in patients with never-treated hypertension has been associated with impaired exercise capacity, but whether this relationship remains in patients with longstanding hypertension and target organ damage is less elucidated. METHODS: In 43...... unmedicated patients with essential hypertension and electrocardiographic left ventricular (LV) hypertrophy, we measured maximal workload and oxygen reserve by bicycle test, 24-h ambulatory blood pressure (BP), LV mass index by magnetic resonance imaging (LVMI(MRI), n = 31), LVMI(echo) and systemic vascular...... compliance by echocardiography, minimal forearm vascular resistance (MFVR) by plethysmography, and intima media thickness and distensibility in the common carotid arteries by ultrasound. RESULTS: The patients did not achieve the maximal workload as predicted by age, gender and body composition (146...

  1. Cosmesis and Breast-Related Quality of Life Outcomes After Intraoperative Radiation Therapy for Early Breast Cancer: A Substudy of the TARGIT-A Trial

    Corica, Tammy, E-mail: Tammy.Corica@health.wa.gov.au [Radiation Oncology Clinical Trials and Research Unit, Comprehensive Cancer Centre, Sir Charles Gairdner Hospital, Nedlands, Western Australia (Australia); School of Medicine and Pharmacology, University of Western Australia, Crawley, Western Australia (Australia); Nowak, Anna K. [School of Medicine and Pharmacology, University of Western Australia, Crawley, Western Australia (Australia); Department of Medical Oncology, Sir Charles Gairdner Hospital, Nedlands, Western Australia (Australia); Saunders, Christobel M. [School of Surgery, University of Western Australia, Crawley, Western Australia (Australia); Department of Surgery Fiona Stanley Hospital, Western Australia (Australia); Bulsara, Max [Institute for Health Research, University of Notre Dame, Fremantle, Western Australia (Australia); Taylor, Mandy [Radiation Oncology, Comprehensive Cancer Centre, Sir Charles Gairdner Hospital Nedlands, Western Australia (Australia); Vaidya, Jayant S. [Department of Surgery, Royal Free Hospital, London (United Kingdom); Clinical Trials Group, Division of Surgery and Interventional Science, University College, London, London (United Kingdom); Department of Surgery, Whittington Health, London (United Kingdom); Baum, Michael [Clinical Trials Group, Division of Surgery and Interventional Science, University College London, London (United Kingdom); Joseph, David J. [School of Surgery, University of Western Australia, Western Australia (Australia); Genesis Cancer Care, Western Australia (Australia); Radiation Oncology, Comprehensive Cancer Centre, Sir Charles Gairdner Hospital, Western Australia (Australia)

    2016-09-01

    Purpose: To report the first comprehensive investigation of patient-reported cosmesis and breast-related quality of life (QOL) outcomes comparing patients randomized to risk-adapted single-dose intraoperative radiation therapy (TARGIT-IORT) versus external beam radiation therapy (EBRT) on the TARGIT-A trial. Methods and Materials: Longitudinal cosmesis and QOL data were collected from a subset of TARGIT-A participants who received TARGIT-IORT as a separate procedure (postpathology). Patients completed a cosmetic assessment before radiation therapy and annually thereafter for at least 5 years. Patients also completed the combined European Organization for Research and Treatment of Cancer (EORTC) core questionnaire and Breast-Specific Module in addition to the Body Image after Breast Cancer Questionnaire at baseline and annually thereafter. The combined EORTC questionnaires were also collected 3, 6, and 9 months after wide local excision. Results: An Excellent–Good cosmetic result was scored more often than a Fair–Poor result for both treatment groups across all time points. The TARGIT-IORT patients reported better breast-related QOL than EBRT patients. Statistically and clinically significant differences were seen at month 6 and year 1, with EBRT patients having moderately worse breast symptoms (a statistically significant difference of more than 10 in a 100-point scale) than TARGIT-IORT patients at these time points. Conclusion: Patients treated with TARGIT-IORT on the TARGIT-A trial have similar self-reported cosmetic outcome but better breast-related QOL outcomes than patients treated with EBRT. This important evidence can facilitate the treatment decision-making process for patients who have early breast cancer suitable for breast-conserving surgery and inform their clinicians.

  2. Novel ICD Programming and Inappropriate ICD Therapy in CRT-D Versus ICD Patients: A MADIT-RIT Sub-Study.

    Kutyifa, Valentina; Daubert, James P; Schuger, Claudio; Goldenberg, Ilan; Klein, Helmut; Aktas, Mehmet K; McNitt, Scott; Stockburger, Martin; Merkely, Bela; Zareba, Wojciech; Moss, Arthur J

    2016-01-01

    The Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate therapy (MADIT-RIT) trial showed a significant reduction in inappropriate implantable cardioverter defibrillator (ICD) therapy in patients programmed to high-rate cut-off (Arm B) or delayed ventricular tachycardia therapy (Arm C), compared with conventional programming (Arm A). There is limited data on the effect of cardiac resynchronization therapy with a cardioverter defibrillator (CRT-D) on the effect of ICD programming. We aimed to elucidate the effect of CRT-D on ICD programming to reduce inappropriate ICD therapy in patients implanted with CRT-D or an ICD, enrolled in MADIT-RIT. The primary end point of this study was the first inappropriate ICD therapy. Secondary end points were inappropriate anti-tachycardia pacing and inappropriate ICD shock. The study enrolled 742 (49%) patients with an ICD and 757 (51%) patients with a CRT-D. Patients implanted with a CRT-D had 62% lower risk of inappropriate ICD therapy than those with an ICD only (hazard ratio [HR] =0.38, 95% confidence interval: 0.25-0.57; Pprogramming significantly reduced the risk of inappropriate ICD therapy compared with conventional ICD programming in ICD (HR=0.14 [B versus A]; HR=0.21 [C versus A]) and CRT-D patients (HR=0.15 [B versus A]; HR=0.23 [C versus A]; Pprogramming significantly reduces the risk of inappropriate ICD therapy in both ICD and CRT-D patients. http://clinicaltrials.gov; Unique identifier: NCT00947310. © 2016 American Heart Association, Inc.

  3. Microalbuminuria and sRAGE in High-Risk Hypertensive Patients Treated with Nifedipine/Telmisartan Combination Treatment: A Substudy of TALENT

    Colomba Falcone

    2012-01-01

    Full Text Available Some antihypertensive drugs have also renoprotective and anti-inflammatory properties that go beyond their effect on blood pressure. It has been suggested that microalbuminuria and glomerular filtration rate (GFR are associated with circulating levels of the soluble form of the receptor, sRAGE (soluble receptor for advanced glycation ends-products. In the present analysis, we used data from the TALENT study to evaluate soluble receptor for advanced glycation end-products (sRAGE plasma levels in patients with hypertension and high-cardiovascular risk-treated nifedipine and telmisartan in combination. Treatment with nifedipine-telmisartan significantly decreased mean systolic and diastolic ambulatory blood pressure and resulted in a significant increase in sRAGE plasma concentrations after 24 weeks of therapy. We concluded that in hypertensive patients with early-stage renal disease, sRAGE concentrations are not influenced by either microalbuminuria or GFR. Long-term treatment with a combination of nifedipine-telmisartan may have a beneficial effect increasing sRAGE plasma levels, thus exerting an atheroprotective and anti-inflammatory activity.

  4. Urinary proteomics predict onset of microalbuminuria in normoalbuminuric type 2 diabetic patients, a sub-study of the DIRECT-Protect 2 study

    Lindhardt, Morten; Persson, Frederik; Zürbig, Petra

    2016-01-01

    BACKGROUND: Early prevention of diabetic nephropathy is not successful as early interventions have shown conflicting results, partly because of a lack of early and precise indicators of disease development. Urinary proteomics has shown promise in this regard and could identify those at high risk...... who might benefit from treatment. In this study we investigate its utility in a large type 2 diabetic cohort with normoalbuminuria. METHODS: We performed a post hoc analysis in the Diabetic Retinopathy Candesartan Trials (DIRECT-Protect 2 study), a multi centric randomized clinical controlled trial...... = 0.002; cNRI 0.10, P = 0.043). CONCLUSIONS: In this cohort of patients with type 2 diabetes and normoalbuminuria from a large intervention study, the CKD273-classifier was an independent predictor of microalbuminuria. This may help identify high-risk normoalbuminuric patients for preventive...

  5. Coronary microvascular dysfunction is not associated with a history of reproductive risk factors in women with angina pectoris-An iPOWER substudy

    Suhrs, Hannah Elena; Kristensen, Anna Meta; Rask, Anna Bay

    2018-01-01

    factors was associated with CMD in women with angina pectoris and no obstructive coronary artery disease (CAD). METHODS: Participants from the iPOWER study, including women with angina pectoris and no obstructive CAD (

  6. Respiratory System Mechanics During Low Versus High Positive End-Expiratory Pressure in Open Abdominal Surgery: A Substudy of PROVHILO Randomized Controlled Trial

    D'Antini, Davide; Huhle, Robert; Herrmann, Jacob; Sulemanji, Demet S.; Oto, Jun; Raimondo, Pasquale; Mirabella, Lucia; Hemmes, Sabrine N. T.; Schultz, Marcus J.; Pelosi, Paolo; Kaczka, David W.; Vidal Melo, Marcos Francisco; Gama de Abreu, Marcelo; Cinnella, Gilda

    2018-01-01

    In the 2014 PROtective Ventilation using HIgh versus LOw positive end-expiratory pressure (PROVHILO) trial, intraoperative low tidal volume ventilation with high positive end-expiratory pressure (PEEP = 12 cm H2O) and lung recruitment maneuvers did not decrease postoperative pulmonary complications

  7. Respiratory System Mechanics During Low Versus High Positive End-Expiratory Pressure in Open Abdominal Surgery: A Substudy of PROVHILO Randomized Controlled Trial.

    D'Antini, Davide; Huhle, Robert; Herrmann, Jacob; Sulemanji, Demet S; Oto, Jun; Raimondo, Pasquale; Mirabella, Lucia; Hemmes, Sabrine N T; Schultz, Marcus J; Pelosi, Paolo; Kaczka, David W; Vidal Melo, Marcos Francisco; Gama de Abreu, Marcelo; Cinnella, Gilda

    2018-01-01

    In the 2014 PROtective Ventilation using HIgh versus LOw positive end-expiratory pressure (PROVHILO) trial, intraoperative low tidal volume ventilation with high positive end-expiratory pressure (PEEP = 12 cm H2O) and lung recruitment maneuvers did not decrease postoperative pulmonary complications when compared to low PEEP (0-2 cm H2O) approach without recruitment breaths. However, effects of intraoperative PEEP on lung compliance remain poorly understood. We hypothesized that higher PEEP leads to a dominance of intratidal overdistension, whereas lower PEEP results in intratidal recruitment/derecruitment (R/D). To test our hypothesis, we used the volume-dependent elastance index %E2, a respiratory parameter that allows for noninvasive and radiation-free assessment of dominant overdistension and intratidal R/D. We compared the incidence of intratidal R/D, linear expansion, and overdistension by means of %E2 in a subset of the PROVHILO cohort. In 36 patients from 2 participating centers of the PROVHILO trial, we calculated respiratory system elastance (E), resistance (R), and %E2, a surrogate parameter for intratidal overdistension (%E2 > 30%) and R/D (%E2 mechanical ventilation with protective tidal volumes in patients undergoing open abdominal surgery, lung recruitment followed by PEEP of 12 cm H2O decreased the incidence of intratidal R/D and did not worsen overdistension, when compared to PEEP ≤2 cm H2O.

  8. Usage of a generic web-based self-management intervention for breast cancer survivors: substudy analysis of the BREATH trial

    Berg, S.W. van den; Peters, E.J.; Kraaijeveld, J.F.; Gielissen, M.F.M.; Prins, J.B.

    2013-01-01

    BACKGROUND: Generic fully automated Web-based self-management interventions are upcoming, for example, for the growing number of breast cancer survivors. It is hypothesized that the use of these interventions is more individualized and that users apply a large amount of self-tailoring. However,

  9. Usage of a generic web-based self-management intervention for breast cancer survivors: substudy analysis of the BREATH trial.

    van den Berg, Sanne W; Peters, Esmee J; Kraaijeveld, J Frank; Gielissen, Marieke F M; Prins, Judith B

    2013-08-19

    Generic fully automated Web-based self-management interventions are upcoming, for example, for the growing number of breast cancer survivors. It is hypothesized that the use of these interventions is more individualized and that users apply a large amount of self-tailoring. However, technical usage evaluations of these types of interventions are scarce and practical guidelines are lacking. To gain insight into meaningful usage parameters to evaluate the use of generic fully automated Web-based interventions by assessing how breast cancer survivors use a generic self-management website. Final aim is to propose practical recommendations for researchers and information and communication technology (ICT) professionals who aim to design and evaluate the use of similar Web-based interventions. The BREAst cancer ehealTH (BREATH) intervention is a generic unguided fully automated website with stepwise weekly access and a fixed 4-month structure containing 104 intervention ingredients (ie, texts, tasks, tests, videos). By monitoring https-server requests, technical usage statistics were recorded for the intervention group of the randomized controlled trial. Observed usage was analyzed by measures of frequency, duration, and activity. Intervention adherence was defined as continuous usage, or the proportion of participants who started using the intervention and continued to log in during all four phases. By comparing observed to minimal intended usage (frequency and activity), different user groups were defined. Usage statistics for 4 months were collected from 70 breast cancer survivors (mean age 50.9 years). Frequency of logins/person ranged from 0 to 45, total duration/person from 0 to 2324 minutes (38.7 hours), and activity from opening none to all intervention ingredients. 31 participants continued logging in to all four phases resulting in an intervention adherence rate of 44.3% (95% CI 33.2-55.9). Nine nonusers (13%), 30 low users (43%), and 31 high users (44%) were defined. Low and high users differed significantly on frequency (PWeb-based interventions. It is recommended to (1) incorporate usage statistics that reflect the amount of self-tailoring applied by users, (2) combine technical usage statistics with self-reported usefulness, and (3) use qualitative measures. Also, (4) a pilot usage evaluation should be a fixed step in the development process of novel Web-based interventions, and (5) it is essential for researchers to gain insight into the rationale of recorded and nonrecorded usage statistics. Netherlands Trial Register (NTR): 2935; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2935 (Archived by WebCite at http://www.webcitation.org/6IkX1ADEV).

  10. Identification of patients at risk of non-adherence to oral antirheumatic drugs in rheumatoid arthritis using the Compliance Questionnaire in Rheumatology: an ARCO sub-study.

    Marras, Carlos; Monteagudo, Indalecio; Salvador, Georgina; de Toro, Francisco J; Escudero, Alejandro; Alegre-Sancho, Juan J; Raya, Enrique; Ortiz, Ana; Carmona, Loreto; Mestre, Yvonne; Cea-Calvo, Luis; Calvo-Alén, Jaime

    2017-07-01

    The ARCO study (Study on Adherence of Rheumatoid Arthritis patients to SubCutaneous and Oral Drugs), a multicenter, non-interventional retrospective study, was primarily designed to assess the percentage of patients [aged ≥18 years with an established rheumatoid arthritis (RA) diagnosis] with non-adherence to prescribed subcutaneous biologicals. This paper reports data for the secondary objective from a subset of patients, namely to evaluate non-adherence to prescribed oral antirheumatic drugs in RA patients in Spain using the validated Compliance Questionnaire Rheumatology (CQR). Patients also completed the Morisky-Green Medication Adherence Questionnaire, Beliefs about Medicines Questionnaire, and a questionnaire (developed and validated in Spain) on patient satisfaction with RA treatment and preferences. A total of 271 patients (76.7% females; mean age 55.6 years) were being treated with oral drugs for RA, of which 234 completed the CQR questionnaire. Non-adherence was reported in 49/234 (20.9%) patients. The proportion of non-adherence in younger patients (aged ≤48 years; 37.5%) was double that recorded in patients aged >48 years (p = 0.006). Patients with a perception of lower efficacy also had a higher risk of non-adherence (p = 0.012). Multivariable analysis showed that younger age and male gender were independently associated with risk of non-adherence. There was only slight agreement between the CQR and Morisky-Green assessment tools (kappa coefficient = 0.186), possibly reflecting the fact that both questionnaires measure slightly different aspects of medication adherence. In conclusion, one out of five RA patients was identified as at risk for non-adherence with the CQR, and this was more frequent in younger patients and in males.

  11. Mitral E wave deceleration time to peak E velocity ratio and cardiovascular outcome in hypertensive patients during antihypertensive treatment (from the LIFE echo-substudy)

    Chinali, Marcello; Aurigemma, Gerard P; de Simone, Giovanni

    2009-01-01

    for mitral peak E-velocity (mitral deceleration index [MDI]) might better predict incident cardiovascular (CV) events in hypertensive patients during treatment compared to DTE alone or other traditional indexes of diastolic function, such as the mitral E/A ratio. We evaluated 770 hypertensive patients.......01). Unadjusted Cox regression analysis showed a positive association between the baseline MDI and CV events (hazard ratio 1.21, 95% confidence interval 1.07 to 1.37, p = 0.002). In the time-varied Cox models, a greater in-treatment MDI was associated with a greater rate of CV events (hazard ratio 1.43, 95...... findings of left ventricular hypertrophy, the MDI independently predicted future CV events. Normalization of DTE for E velocity might be preferred to other traditional diastolic function indexes in evaluating diastolic function during antihypertensive treatment....

  12. Additive effects of LPL, APOA5 and APOE variant combinations on triglyceride levels and hypertriglyceridemia: results of the ICARIA genetic sub-study

    2010-01-01

    Background Hypertriglyceridemia (HTG) is a well-established independent risk factor for cardiovascular disease and the influence of several genetic variants in genes related with triglyceride (TG) metabolism has been described, including LPL, APOA5 and APOE. The combined analysis of these polymorphisms could produce clinically meaningful complementary information. Methods A subgroup of the ICARIA study comprising 1825 Spanish subjects (80% men, mean age 36 years) was genotyped for the LPL-HindIII (rs320), S447X (rs328), D9N (rs1801177) and N291S (rs268) polymorphisms, the APOA5-S19W (rs3135506) and -1131T/C (rs662799) variants, and the APOE polymorphism (rs429358; rs7412) using PCR and restriction analysis and TaqMan assays. We used regression analyses to examine their combined effects on TG levels (with the log-transformed variable) and the association of variant combinations with TG levels and hypertriglyceridemia (TG ≥ 1.69 mmol/L), including the covariates: gender, age, waist circumference, blood glucose, blood pressure, smoking and alcohol consumption. Results We found a significant lowering effect of the LPL-HindIII and S447X polymorphisms (p hypertriglyceridemia. PMID:20429872

  13. Reproductive hormone analyses and effects of adjuvant zoledronic acid in early breast cancer – An AZURE (BIG 01/04 sub-study

    Caroline Wilson

    2017-11-01

    Full Text Available Purpose: Adjuvant bisphosphonates have been shown to improve disease outcomes in early breast cancer in women who are postmenopausal at the start of treatment. We explored the influence of pretreatment serum levels of reproductive hormones in the hypothalamic-pituitary-gonadal (HPG axis from a subset of patients included in the AZURE trial to investigate their impact on disease recurrence and whether reproductive hormone measurements are of value in selecting patients for treatment with adjuvant zoledronic acid.Patients and methods; The AZURE trial is an academic, multi-centre, international phase III trial that randomised patients to standard adjuvant therapy (chemotherapy and/or endocrine therapy±intravenous zoledronic acid, 4 mg for 5 years. Serum from 865 patients taken at randomisation was stored at −80 °C prior to central batch analysis for inhibin A, oestradiol and follicle stimulating hormone (FSH. We assessed the clinical value of pretreatment hormone levels for predicting invasive disease free survival (IDFS, skeletal recurrence and distant recurrence and response to treatment with zoledronic acid. Results: Oestradiol in the postmenopausal range (26 IU/l was associated with a longer time to bone as first recurrence (HR 0.66 95%CI: 0.41–1.04 p=0.072 compared to an FSH ≤26 IU/l. When all 3 hormone levels were within the assay specified postmenopausal range, a trend to improved IDFS was seen with addition of zoledronic acid in biochemically postmenopausal women only (postmenopausal HR=0.81; 95%CI: 0.54–1.22, non-postmenopausal HR=0.99; 95%CI: 0.69–1.39 with risk reductions that mirrored the results of the main AZURE study, although the interaction between menopausal status and treatment effect was not statistically significant (p=0.47. Conclusion: Oestradiol and FSH may influence the pattern of disease recurrence with postmenopausal levels possibly creating a less conducive environment for the formation of bone metastases, therefore disseminated tumour cells could seek alternative niches outside of bone. Biochemical evaluation of a panel of reproductive hormones may be helpful to assist selection of patients for adjuvant zoledronic acid when menopausal status is unknown. Keywords: Adjuvant, Bisphosphonate, Breast, Reproductive hormones, Recurrence

  14. Cosmesis and Breast-Related Quality of Life Outcomes After Intraoperative Radiation Therapy for Early Breast Cancer: A Substudy of the TARGIT-A Trial

    Corica, Tammy; Nowak, Anna K.; Saunders, Christobel M.; Bulsara, Max; Taylor, Mandy; Vaidya, Jayant S.; Baum, Michael; Joseph, David J.

    2016-01-01

    Purpose: To report the first comprehensive investigation of patient-reported cosmesis and breast-related quality of life (QOL) outcomes comparing patients randomized to risk-adapted single-dose intraoperative radiation therapy (TARGIT-IORT) versus external beam radiation therapy (EBRT) on the TARGIT-A trial. Methods and Materials: Longitudinal cosmesis and QOL data were collected from a subset of TARGIT-A participants who received TARGIT-IORT as a separate procedure (postpathology). Patients completed a cosmetic assessment before radiation therapy and annually thereafter for at least 5 years. Patients also completed the combined European Organization for Research and Treatment of Cancer (EORTC) core questionnaire and Breast-Specific Module in addition to the Body Image after Breast Cancer Questionnaire at baseline and annually thereafter. The combined EORTC questionnaires were also collected 3, 6, and 9 months after wide local excision. Results: An Excellent–Good cosmetic result was scored more often than a Fair–Poor result for both treatment groups across all time points. The TARGIT-IORT patients reported better breast-related QOL than EBRT patients. Statistically and clinically significant differences were seen at month 6 and year 1, with EBRT patients having moderately worse breast symptoms (a statistically significant difference of more than 10 in a 100-point scale) than TARGIT-IORT patients at these time points. Conclusion: Patients treated with TARGIT-IORT on the TARGIT-A trial have similar self-reported cosmetic outcome but better breast-related QOL outcomes than patients treated with EBRT. This important evidence can facilitate the treatment decision-making process for patients who have early breast cancer suitable for breast-conserving surgery and inform their clinicians.

  15. A possible link between endothelial dysfunction and insulin resistance in hypertension. A LIFE substudy. Losartan Intervention For Endpoint-Reduction in Hypertension

    Olsen, M H; Andersen, U B; Wachtell, K

    2000-01-01

    We wanted to investigate whether insulin resistance and time to steady state during isoglycemic clamp were associated with endothelial dysfunction, peripheral vascular remodeling and forearm blood flow (FBF) in patients with longstanding hypertension....

  16. Maximal exercise capacity is related to cardiovascular structure in patients with longstanding hypertension. A LIFE substudy. Losartan Intervention For Endpoint-Reduction in Hypertension

    Olsen, M H; Wachtell, K; Hermann, K L

    2001-01-01

    unmedicated patients with essential hypertension and electrocardiographic left ventricular (LV) hypertrophy, we measured maximal workload and oxygen reserve by bicycle test, 24-h ambulatory blood pressure (BP), LV mass index by magnetic resonance imaging (LVMI(MRI), n = 31), LVMI(echo) and systemic vascular...

  17. Help seeking behavior and onset-to-alarm time in patients with acute stroke: sub-study of the preventive antibiotics in stroke study

    Zock, E.; Kerkhoff, H.; Kleyweg, R. P.; van Bavel-Ta, T. B. V.; Scott, S.; Kruyt, N. D.; Nederkoorn, P. J.; van de Beek, D.

    2016-01-01

    Patients with acute stroke often do not seek immediate medical help, which is assumed to be driven by lack of knowledge of stroke symptoms. We explored the process of help seeking behavior in patients with acute stroke, evaluating knowledge about stroke symptoms, socio-demographic and clinical

  18. Patient Experience of Symptoms and Side Effects when Treated with Osimertinib for Advanced Non-Small-Cell Lung Cancer: A Qualitative Interview Substudy.

    Rydén, Anna; Blackhall, Fiona; Kim, Hye Ryun; Pillai, Rathi N; Braam, Lauren; Martin, Mona L; Walding, Andrew

    2017-10-01

    Capturing the patient experience during treatment is important to both regulatory authorities and to patients starting treatment. We identified the symptoms and side effects experienced by patients with advanced non-small-cell lung cancer during osimertinib treatment, to understand treatment expectations, satisfaction, and the level of difficulty coping with the side effects experienced during treatment. Qualitative interviews (approximately 4-6 weeks after treatment initiation and again after approximately 4 months of treatment) were conducted during the phase I/II AURA clinical trial of osimertinib, a tyrosine kinase inhibitor of epidermal growth factor receptor-sensitizing and T790M resistance mutations. During the first interview (23 patients), the most commonly reported symptoms/side effects were coughing, itching, tiredness (each reported by 56.5% of patients), and rash (43.5%). During the second interview (21 patients), compared with the first interview, shortness of breath and diarrhea were reported by more patients (57.1 and 38.1%, respectively; both increased from 34.8%); tiredness remained predominant (42.9%); and itching (38.1%), coughing (38.1%), and rash (14.3%) were reported by fewer patients. At both interviews, the most frequently reported symptoms/side effects were also those most often rated by patients for bothersomeness and severity, and generally received mean scores in the low-to-moderate range. However, several rarely expressed symptoms/side effects (e.g., abdominal pain, frequent day time urination) received high bothersomeness ratings. At the second interview, patients were highly satisfied with osimertinib and had a low level of difficulty in coping with side effects during treatment. These data enhance our understanding of patients' experiences of symptoms/side effects, which could increase the accuracy of the osimertinib benefit-risk assessment, guide management of adverse events, and improve the information given to patients receiving the drug.

  19. Radiographic case definitions and prevalence of osteoarthrosis of the hip: a survey of 4 151 subjects in the Osteoarthritis Substudy of the Copenhagen City Heart Study

    Jacobsen, Steffen; Sonne-Holm, Stig; Søballe, Kjeld

    2004-01-01

    : Formation of cysts, osteophytes and subchondral sclerosis was significantly more frequent in men. Average minimum JSW was narrower in women than in men (p ... composite OA scores emphasizing the relatively inconsequential formation of cysts, osteophytes and subchondral sclerosis runs the risk of over-inflating the prevalence of hip OA in men and of underestimating hip OA prevalence in women....

  20. The distribution and inter-relationships of radiologic features of osteoarthrosis of the hip. A survey of 4151 subjects of the Copenhagen City Heart Study: the Osteoarthrosis Substudy

    Jacobsen, Steffen; Sonne-Holm, Stig; Søballe, Kjeld

    2004-01-01

    -relationships and correlations to age, sex, body mass index (BMI) and occupational exposure to repeated lifting. RESULTS: Overall, subchondral sclerosis, cysts and osteophytes were more frequently recorded in male hip joints compared to female hip joints, while a decrease in minimum JSW by age was more pronounced...... and progressive in women after the fifth decade compared to men. Applying logistic regression analyses, only age was found to be significantly associated to pathologically reduced minimum JSW (cut off value set at osteophytes and subchondral cysts in both sexes (P ranging from 0.......00 to 0.03). Minimum JSW subchondral cysts, osteophytes and sclerosis were found to be significantly inter-related to minimum JSW

  1. Are left ventricular mass, geometry and function related to vascular changes and/or insulin resistance in long-standing hypertension? ICARUS: a LIFE substudy

    Olsen, M H; Hjerkinn, E; Wachtell, K

    2003-01-01

    Vascular hypertrophy and insulin resistance have been associated with abnormal left ventricular (LV) geometry in population studies. We wanted to investigate the influence of vascular hypertrophy and insulin resistance on LV hypertrophy and its function in patients with hypertension. In 89 patients...

  2. Differential effects of tissue plasminogen activator and streptokinase on infarct size and on rate of enzyme release: influence of early infarct related artery patency : The GUSTO Enzyme Substudy

    T. Baardman (Taco); W.T. Hermens (Wim); G.P. Molhoek; G. Grollier (Gilles); M.E. Pfisterer (Matthias); M.L. Simoons (Maarten); T. Lenderink (Timo)

    1996-01-01

    textabstractBACKGROUND: The recent international GUSTO trial of 41,021 patients with acute myocardial infarction demonstrated improved 90-min infarct related artery patency as well as reduced mortality in patients treated with an accelerated regimen of tissue plasminogen activator, compared to

  3. Additive effects of LPL, APOA5 and APOE variant combinations on triglyceride levels and hypertriglyceridemia: results of the ICARIA genetic sub-study

    Valdivielso Pedro

    2010-04-01

    Full Text Available Abstract Background Hypertriglyceridemia (HTG is a well-established independent risk factor for cardiovascular disease and the influence of several genetic variants in genes related with triglyceride (TG metabolism has been described, including LPL, APOA5 and APOE. The combined analysis of these polymorphisms could produce clinically meaningful complementary information. Methods A subgroup of the ICARIA study comprising 1825 Spanish subjects (80% men, mean age 36 years was genotyped for the LPL-HindIII (rs320, S447X (rs328, D9N (rs1801177 and N291S (rs268 polymorphisms, the APOA5-S19W (rs3135506 and -1131T/C (rs662799 variants, and the APOE polymorphism (rs429358; rs7412 using PCR and restriction analysis and TaqMan assays. We used regression analyses to examine their combined effects on TG levels (with the log-transformed variable and the association of variant combinations with TG levels and hypertriglyceridemia (TG ≥ 1.69 mmol/L, including the covariates: gender, age, waist circumference, blood glucose, blood pressure, smoking and alcohol consumption. Results We found a significant lowering effect of the LPL-HindIII and S447X polymorphisms (p APOE-ε4 allele were significantly associated with an independent additive TG-raising effect (p p p p p p p = 0.042 and having one single raising polymorphism (OR = 1.20; 95% CI, 1.39-2.87; p p Conclusion Our results showed a significant independent additive effect on TG levels of the LPL polymorphisms HindIII, S447X, D9N and N291S; the S19W and -1131T/C variants of APOA5, and the ε4 allele of APOE in our study population. Moreover, some of the variant combinations studied were significantly associated with the absence or the presence of hypertriglyceridemia.

  4. Red Flags for Maltese Adults with Congenital Heart Disease: Poorer Dental Care and Less Sports Participation Compared to Other European Patients-An APPROACH-IS Substudy.

    Caruana, Maryanne; Apers, Silke; Kovacs, Adrienne H; Luyckx, Koen; Thomet, Corina; Budts, Werner; Sluman, Maayke; Eriksen, Katrine; Dellborg, Mikael; Berghammer, Malin; Johansson, Bengt; Soufi, Alexandra; Callus, Edward; Moons, Philip; Grech, Victor

    2017-06-01

    Studies in recent years have explored lifestyle habits and health-risk behaviours in adult congenital heart disease (ACHD) patients when compared to controls. The aim of this study was to investigate differences in lifestyle habits between Maltese and other European ACHD patients. Data on alcohol consumption, cigarette smoking, substance misuse, dental care and physical activity collected in 2013-2015 during "Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease-International Study" (APPROACH-IS) were analysed. Responses from 119 Maltese participants were compared to those of 1616 participants from Belgium, France, Italy, Norway, Sweden, Switzerland and the Netherlands. Significantly fewer Maltese patients with simple (Maltese 84.1% vs. European 97.5%, p < 0.001) and moderately complex CHD (Maltese 83.6% vs. European 97.4%, p < 0.001) brushed their teeth daily. Only 67.2% of Maltese with moderately complex disease had dental reviews in the previous year compared to 80.3% of Europeans (p = 0.02). Maltese patients with simple (Maltese 31.8% vs. European 56.1%, p = 0.002) and moderately complex lesions (Maltese 30.0% vs. European 59.2%, p < 0.001) performed less regular sport activities. Comparison by country showed Maltese patients to have significantly poorer tooth brushing and sports participation than patients from any other participating country. Alcohol consumption, cigarette smoking and substance misuse were not significantly different. This study highlights lifestyle aspects that Maltese ACHD patients need to improve on, which might not be evident upon comparing patients to non-CHD controls. These findings should also caution researchers against considering behaviours among patients in one country as necessarily representative of patients on the larger scale.

  5. Validation of CARE-Q in residential aged-care: rating of importance of caring behaviours from an e-cohort sub-study.

    Tuckett, Anthony G; Hughes, Karen; Schluter, Philip J; Turner, Cathy

    2009-05-01

    To validate the Caring Assessment Report Evaluation Q-sort questionnaire in the residential aged-care setting. Based on this determination, to conclude with what degree of confidence the questionnaire can be used to determine the ranking of the importance of caring behaviours amongst aged-care nurses and residents in residential aged-care. Perceptions of caring may be context specific. Caring in residential aged-care may stand in contrast to the sense of caring understood and practiced in other settings. Self-administered survey. Residents from three not-for-profit aged-care facilities, across both high-care (nursing-home) and low-care (hostel care) were surveyed relying on the Caring Assessment Report Evaluation Q-sort questionnaire. A sub-sample of registered and enrolled nurses working in residential aged-care and registered with the Nurses & Midwives e-cohort study completed the same survey. Although the Caring Assessment Report Evaluation Q-sort questionnaire showed good internal consistency for the sample of nurses, the results for the residents were more erratic. Both groups displayed large ranges for the inter-item correlations. The results of the Mann-Whitney U-test indicated that the nurses rated the Comforts, Anticipates and Trusting relationship as significantly more important than the residents. Both groups rated the Explains and facilitates subscale as least important. All subscales, however, received median scores greater than, or equal to, six (seven-point, Likert scale) indicating that all were considered important overall. Based on poor Cronbach's alpha coefficients, negative inter-item correlations and qualitative observations, without further development within the residential aged-care facility the free response format version of the Caring Assessment Report Evaluation Q-sort may not be an appropriate measure to use with residential aged-care residents. More research needs to be conducted into how residents and nurses are interpreting the items in the Caring Assessment Report Evaluation Q-sort. There will always remain a need for nurses to enact behaviours that are meaningful to residents (and patients generally).

  6. High-sensitivity troponin-T as a prognostic marker after out-of-hospital cardiac arrest - A targeted temperature management (TTM) trial substudy

    Gilje, Patrik; Koul, Sasha; Thomsen, Jakob Hartvig

    2016-01-01

    -TnT) is a prognostic marker among survivors of OHCA with both ischemic and non-ischemic aetiologies remains to be determined. We sought to evaluate the ability of hs-TnT to prognosticate all-cause mortality, death due to cardiovascular causes or multi-organ failure and death due to cerebral causes after OHCA...... circulation (ROSC). The endpoints were 180 day all-cause mortality, death due to cardiovascular causes or multi-organ failure and death due to cerebral causes. Subgroups based on the initial ECG after ROSC (STEMI vs all other ECG presentations) were analyzed. RESULTS: Hs-TnT was independently associated.......05). In patients with STEMI, hs-TnT was independently associated with death due to cardiovascular causes or multi-organ failure (at 48h: OR 1.47, CI 1.10-1.95, pnon...

  7. Changes in subclinical organ damage vs. in Framingham risk score for assessing cardiovascular risk reduction during continued antihypertensive treatment: a LIFE substudy

    Olsen, Michael H; Wachtell, Kristian; Ibsen, Hans

    2011-01-01

    To investigate whether in-treatment measurements of subclinical organ damage (SOD) assessed by elevated urine albumin/creatinine ratio (UACR) or electrocardiographic left ventricular hypertrophy improved the prediction of the composite cardiovascular endpoint of cardiovascular death, nonfatal...

  8. Effects of combination treatment with losartan and trandolapril on office and ambulatory blood pressures in non-diabetic renal disease: a COOPERATE-ABP substudy.

    Nakao, Naoyuki; Seno, Hachiro; Kasuga, Hirotake; Toriyama, Takanobu; Kawahara, Hirohisa; Fukagawa, Masafumi

    2004-01-01

    In the COOPERATE trial, the combination treatment of the angiotensin-II receptor blocker losartan and the angiotensin-converting-enzyme inhibitor trandolapril significantly retarded progression of non-diabetic kidney disease compared with each monotherapy. The benefit could be greatly attributable to the potent reduction of proteinuria, because the three treatment groups showed the same reductions of office blood pressure (OBP). Ambulatory blood pressure (ABP) is reported to be better than OBP in predicting progression of kidney disease. Ninety-two patients enrolled in the COOPERATE trial underwent 24-hour ABP monitoring at randomization and at month 6, year 1, year 2 and year 3 on randomized treatment. Both OBP and ABP were similarly reduced among the three groups at all measurement points (p = NS) and throughout the whole study period (p = NS). No significant correlation between the change in 24-hour ABP and the change in proteinuria was seen (p = NS). A Cox-multivariable analysis showed that covariates affecting the renal outcomes (a doubling serum-Cr level and/or end-stage renal failure) were the change in proteinuria (hazard ratio 0.49, 95% CI 0.34-0.78, p = 0.01) and treatments (0.58, 0.45-0.99, 0.03), but not 24-hour ABP (0.98, 0.89-2.01, 0.17). The better renoprotective effect of the combination treatment is attributed to BP-independent mechanisms by more complete renin-angiotensin system blockade. 2004 S. Karger AG, Basel

  9. Effects of intensive glucose lowering on brain structure and function in people with type 2 diabetes (ACCORD MIND): a randomised open-label substudy.

    Launer, Lenore J; Miller, Michael E; Williamson, Jeff D; Lazar, Ron M; Gerstein, Hertzel C; Murray, Anne M; Sullivan, Mark; Horowitz, Karen R; Ding, Jingzhong; Marcovina, Santica; Lovato, Laura C; Lovato, James; Margolis, Karen L; O'Connor, Patrick; Lipkin, Edward W; Hirsch, Joy; Coker, Laura; Maldjian, Joseph; Sunshine, Jeffrey L; Truwit, Charles; Davatzikos, Christos; Bryan, R Nick

    2011-11-01

    People with type 2 diabetes are at risk of cognitive impairment and brain atrophy. We aimed to compare the effects on cognitive function and brain volume of intensive versus standard glycaemic control. The Memory in Diabetes (MIND) study was done in 52 clinical sites in North America as part of Action to Control Cardiovascular Risk in Diabetes (ACCORD), a double two-by-two factorial parallel group randomised trial. Participants (aged 55-80 years) with type 2 diabetes, high glycated haemoglobin A(1c) (HbA(1c)) concentrations (>7·5%; >58 mmol/mol), and a high risk of cardiovascular events were randomly assigned to receive intensive glycaemic control targeting HbA(1c) to less than 6·0% (42 mmol/mol) or a standard strategy targeting HbA(1c) to 7·0-7·9% (53-63 mmol/mol). Randomisation was via a centralised web-based system and treatment allocation was not masked from clinic staff or participants. We assessed our cognitive primary outcome, the Digit Symbol Substitution Test (DSST) score, at baseline and at 20 and 40 months. We assessed total brain volume (TBV), our primary brain structure outcome, with MRI at baseline and 40 months in a subset of participants. We included all participants with follow-up data in our primary analyses. In February, 2008, raised mortality risk led to the end of the intensive treatment and transition of those participants to standard treatment. We tested our cognitive function hypotheses with a mixed-effects model that incorporated information from both the 20 and 40 month outcome measures. We tested our MRI hypotheses with an ANCOVA model that included intracranial volume and factors used to stratify randomisation. This study is registered with ClinicalTrials.gov, number NCT00182910. We consecutively enrolled 2977 patients (mean age 62·5 years; SD 5·8) who had been randomly assigned to treatment groups in the ACCORD study. Our primary cognitive analysis was of patients with a 20-month or 40-month DSST score: 1378 assigned to receive intensive treatment and 1416 assigned to receive standard treatment. Of the 614 patients with a baseline MRI, we included 230 assigned to receive intensive treatment and 273 assigned to receive standard treatment in our primary MRI analysis at 40 months. There was no significant treatment difference in mean 40-month DSST score (difference in mean 0·32, 95% CI -0·28 to 0·91; p=0·2997). The intensive-treatment group had a greater mean TBV than the standard-treatment group (4·62, 2·0 to 7·3; p=0·0007). Although significant differences in TBV favoured the intensive treatment, cognitive outcomes were not different. Combined with the non-significant effects on other ACCORD outcomes, and increased mortality in participants in the intensive treatment group, our findings do not support the use of intensive therapy to reduce the adverse effects of diabetes on the brain in patients with similar characteristics to those of our participants. US National Institute on Aging and US National Heart, Lung, and Blood Institute. Copyright © 2011 Elsevier Ltd. All rights reserved.

  10. Self-efficacy and embodiment associated with Alexander Technique lessons or with acupuncture sessions: A longitudinal qualitative sub-study within the ATLAS trial.

    Wenham, Aniela; Atkin, Karl; Woodman, Julia; Ballard, Kathleen; MacPherson, Hugh

    2018-05-01

    A large randomised controlled trial found that the provision of either Alexander Technique lessons or acupuncture, for those with chronic neck pain, resulted in significantly increased self-efficacy when compared with usual care alone. In turn, enhanced self-efficacy was associated with significant reductions in neck pain at 6 and 12 months. In this analysis we explore the perspectives of participants within the trial, with the aim of gaining a better understanding of how these interventions had an impact. We used a longitudinal qualitative approach; in-depth interviews, informed by a topic guide, were conducted with a sample of the trial population. Participants were interviewed twice: at around six months (n = 30) and twelve months (n = 26) after trial entry. Analysis was guided by the principles of grounded theory, and key themes were developed. Five key themes emerged: pre-trial experiences of biomedical treatment against which subsequent interventions were compared; emergence of tangible benefits from the interventions; factors that contributed to the observed benefits, notably growing self-care and self-efficacy; a developing sense of embodiment as an integral part of the transformative process; and contribution of these factors to sustaining benefits over the longer term. In-depth interviews revealed a rich array of experiences. They gave insight into the positive impact of the interventions on development of self-care, self-efficacy and embodiment. These findings complement the quantitative trial data, providing a more nuanced understanding of the factors that underpin the previously quantified improvement in self-efficacy and its association with longer-term reductions in pain. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  11. New ischaemic brain lesions on MRI after stenting or endarterectomy for symptomatic carotid stenosis: a substudy of the International Carotid Stenting Study (ICSS)

    Bonati, Leo H.; Jongen, Lisa M.; Haller, Sven; Flach, H. Zwenneke; Dobson, Joanna; Nederkoorn, Paul J.; Macdonald, Sumaira; Gaines, Peter A.; Waaijer, Annet; Waajier, Annet; Stierli, Peter; Jäger, H. Rolf; Lyrer, Philippe A.; Kappelle, L. Jaap; Wetzel, Stephan G.; van der Lugt, Aad; Mali, Willem P.; Brown, Martin M.; van der Worp, H. Bart; Engelter, Stefan T.; Koelemaij, M. J. W.; Majoie, C. B. L. M.; Reekers, J. A. A.; Roos, Y. B. W. E. M.; Flach, H. Z.; Hendriks, J. M.; Koudstaal, P. J.; Pattynama, P. M. T.; van Dijk, L. C.; van Sambeek, M. R. H. M.; van der Lugt, A.; van Urk, H.; Verhagen, H. J. M.; de Borst, G. J.; de Kort, G. A. P.; Jongen, L. M.; Kappelle, L. J.; Lo, T. H.; Mali, W. P. Th M.; Moll, F. L.; van der Worp, H. B.; Bonati, L. H.; Engelter, S. T.; Fluri, F.; Haller, S.; Jacob, A. L.; Kirsch, E.; Lyrer, P. A.; Radue, E.-W.; Stierli, P.

    2010-01-01

    BACKGROUND: The International Carotid Stenting Study (ICSS) of stenting and endarterectomy for symptomatic carotid stenosis found a higher incidence of stroke within 30 days of stenting compared with endarterectomy. We aimed to compare the rate of ischaemic brain injury detectable on MRI between the

  12. Impact of gender on infarct size, ST-segment resolution, myocardial blush and clinical outcomes after primary stenting for acute myocardial infarction: Substudy from the EMERALD trial.

    Ng, Vivian G; Mori, Ken; Costa, Ricardo A; Kish, Mitra; Mehran, Roxana; Urata, Hidenori; Saku, Keijiro; Stone, Gregg W; Lansky, Alexandra J

    2016-03-15

    Women with AMI may have worse outcomes than men. However, it is unclear if this is related to differences in treatment, treatment effect or gender specific factors. We sought to determine whether primary percutaneous intervention (PCI) has a differential impact on infarct size, myocardial perfusion and ST segment resolution in men and women with acute myocardial infarction (AMI). A total of 501 AMI patients were prospectively enrolled in the EMERALD study and underwent PCI with or without distal protection. Post hoc gender subset analysis was performed. 501 patients (108 women, 393 men) with ST-segment elevation AMI presenting within 6h underwent primary (or rescue) PCI with stenting and a distal protection device. Women were older, had more hypertension, less prior AMI, smaller BSA, and smaller vessel size, but had similar rates of diabetes (30% versus 20.2%, p=0.87), LAD infarct, and time-to-reperfusion compared to men. Women more frequently had complete ST-resolution (>70%) at 30days (72.8% versus 59.8%, p=0.02), and smaller infarct size compared to males (12.2±19.6% versus 18.4±18.5%, p=0.006). At 6months, TLR (6.9% versus 5.2%) and MACE (11.4% versus 10.3%) were similar for women and men. Despite worse comorbidities, women with AMI treated with primary PCI with stenting showed similar early and midterm outcomes compared to men. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  13. Rationale and design of the CAROLINA® - cognition substudy: A randomised controlled trial on cognitive outcomes of linagliptin versus glimepiride in patients with type 2 diabetes mellitus

    G.J. Biessels (Geert Jan); Janssen, J. (Jolien); E. van den Berg (Esther); Zinman, B. (Bernard); Espeland, M.A. (Mark A.); Mattheus, M. (Michaela); Johansen, O.E. (Odd Erik)

    2018-01-01

    textabstractBackground: Type 2 diabetes mellitus is associated with cognitive dysfunction and an increased risk of dementia. Linagliptin is a glucose-lowering agent of the dipeptidyl peptidase-IV (DPP-IV) inhibitor class that is of particular interest for the prevention of accelerated cognitive

  14. Humidification mitigates acute mucosal toxicity during radiotherapy when factoring volumetric parameters. Trans Tasman Radiation Oncology Group (TROG) RadioHUM 07.03 substudy.

    Macann, A; Fauzi, F; Simpson, J; Sasso, G; Krawitz, H; Fraser-Browne, C; Manitz, J; Raith, A

    2017-12-01

    To model in a subset of patients from TROG 07.03 managed at a single site the association between domiciliary based humidification use and mucositis symptom burden during radiotherapy (RT) for head and neck cancer (HNC) when factoring in volumetric radiotherapy parameters derived from tumour and normal tissue regions of interest. From June 2008 through June 2011, 210 patients with HNC receiving RT were randomised to either a control arm or humidification using the Fisher & Paykel Healthcare MR880 humidifier. This subset analysis involves patients recruited from Auckland City Hospital treated with a prescribed dose of ≥70 Gy. Regression models included control variables for Planning Target Volume 70 GY (PTV70Gy); Equivalent Uniform Dose (EUD) MOIST and TSV (surrogates of total mucosal and total swallowing volumes respectively). The analysis included 39 patients (humidification 20, control 19). There was a significant odds reduction in CTCAE v3.0 functional mucositis score of 0.29 associated with the use of humidification (pfactor of 11.11 for humidification patients (p=.013). The results support the hypothesis that humidification can help mitigate mucositis symptom burden. Radiotherapy dosimetric parameters assist in the evaluation of toxicity interventions. Copyright © 2017 Elsevier Ltd. All rights reserved.

  15. Provisional versus elective two-stent strategy for unprotected true left main bifurcation lesions: Insights from a FAILS-2 sub-study.

    Kawamoto, Hiroyoshi; Chieffo, Alaide; D'Ascenzo, Fabrizio; Jabbour, Richard J; Naganuma, Toru; Cerrato, Enrico; Ugo, Fabrizio; Pavani, Marco; Varbella, Ferdinando; Boccuzzi, Giacomo; Pennone, Mauro; Garbo, Roberto; Conrotto, Federico; Biondi-Zoccai, Giuseppe; D'Amico, Maurizio; Moretti, Claudio; Escaned, Javier; Gaita, Fiorenzo; Nakamura, Sunao; Colombo, Antonio

    2018-01-01

    This study sought to investigate the optimal percutaneous coronary intervention (PCI) strategy for true unprotected left main coronary artery (ULMCA) bifurcations. The FAILS-2 was a retrospective multi-center study including patients with ULMCA disease treated with second-generation drug-eluting stents. Of these, we compared clinical outcomes of a provisional strategy (PS; n=216) versus an elective two-stent strategy (E2S; n=161) for true ULMCA bifurcations. The primary endpoint was the incidence of major adverse cardiac events (MACEs) at 3-years. We further performed propensity-score adjustment for clinical outcomes. There were no significant differences between the groups in terms of patient and lesion characteristics. 9.7% of patients in the PS group crossed over to a provisional two-stent strategy. MACEs were not significantly different between groups (MACE at 3-year; PS 28.1% vs. E2S 28.9%, adjusted p=0.99). The rates of target lesion revascularization (TLR) on the circumflex artery (LCX) were numerically high in the E2S group (LCX-TLR at 3-years; PS 11.8% vs. E2S 16.6%, adjusted p=0.51). E2S was associated with a comparable MACE rate to PS for true ULMCA bifurcations. The rates of LCX-TLR tended to be higher in the E2S group although there was no statistical significance. This study sought to compare the clinical outcomes of a provisional strategy (PS) with an elective two-stent strategy (E2S) for the treatment of true unprotected left main coronary artery bifurcations. 377 Patients (PS 216 vs. E2S 161 patients) were evaluated, and 9.7% in the PS group crossed over to a two-stent strategy. E2S was associated with a similar major adverse cardiac event rate at 3-years when compared to the PS strategy (PS 28.1% vs. E2S 28.9%, p=0.99). However, the left circumflex artery TLR rate at 3-year tended to be higher in the E2S group (PS 11.8% vs. E2S 16.6%, p=0.51). Copyright © 2017 Elsevier B.V. All rights reserved.

  16. In-hospital outcome in patients with ST elevation myocardial infarction and right bundle branch block. A sub-study from RENASICA II, a national multicenter registry.

    Juárez-Herrera, Ursulo; Jerjes Sánchez, Carlos; González-Pacheco, Héctor; Martínez-Sánchez, Carlos

    2010-01-01

    Compare in-hospital outcome in patients with ST-elevation myocardial infarction with right versus left bundle branch block. RENASICA II, a national Mexican registry enrolled 8098 patients with final diagnosis of acute coronary syndrome secondary to ischemic heart disease. In 4555 STEMI patients, 545 had bundle branch block, 318 (58.3%) with right and 225 patients with left (41.6%). Both groups were compared in terms of in-hospital outcome through major cardiovascular adverse events; (cardiovascular death, recurrent ischemia and reinfarction). Multivariable analysis was performed to identify in-hospital mortality risk among right and left bundle branch block patients. There were not statistical differences in both groups regarding baseline characteristics, time of ischemia, myocardial infarction location, ventricular dysfunction and reperfusion strategies. In-hospital outcome in bundle branch block group was characterized by a high incidence of major cardiovascular adverse events with a trend to higher mortality in patients with right bundle branch block (OR 1.70, CI 1.19 - 2.42, p right bundle branch block accompanying ST-elevation myocardial infarction of any location at emergency room presentation was an independent predictor of high in-hospital mortality.

  17. The predictive value of CHADS₂ risk score in post myocardial infarction arrhythmias - a Cardiac Arrhythmias and RIsk Stratification after Myocardial infArction (CARISMA) substudy

    Ruwald, Anne-Christine Huth; Gang, Uffe; Thomsen, Poul Erik Bloch

    2014-01-01

    BACKGROUND: Previous studies have shown substantially increased risk of cardiac arrhythmias and sudden cardiac death in post-myocardial infarction (MI) patients. However it remains difficult to identify the patients who are at highest risk of arrhythmias in the post-MI setting. The purpose...... of this study was to investigate if CHADS₂ score (congestive heart failure, hypertension, age ≥75 years, diabetes and previous stroke/TCI [doubled]) can be used as a risk tool for predicting cardiac arrhythmias after MI. METHODS: The study included 297 post-MI patients from the CARISMA study with left....... Patients were stratified according to CHADS₂ score at enrollment. Congestive heart failure was defined as LVEF ≤40% and NYHA class II, III or IV. RESULTS: We found significantly increased risk of an arrhythmic event with increasing CHADS₂ score (CHADS₂ score=1-2: HR=2.1 [1.1-3.9], p=0.021, CHADS₂ score ≥ 3...

  18. A predictive model to identify patients with suspected acute coronary syndromes at high risk of cardiac arrest or in-hospital mortality: An IMMEDIATE Trial sub-study

    Madhab Ray

    2015-12-01

    Conclusions: The multivariable predictive model developed identified patients with very early ACS at high risk of cardiac arrest or death. Using this model could assist treating those with greatest potential benefit from GIK.

  19. The Impact of Preradiation Residual Disease Volume on Time to Locoregional Failure in Cutaneous Merkel Cell Carcinoma—A TROG Substudy

    Finnigan, Renee [Division of Cancer Services, Princess Alexandra Hospital, University of Queensland, Brisbane (Australia); Hruby, George [Department of Radiation Oncology, Sydney Cancer Centre, University of Sydney, Sydney (Australia); Wratten, Chris [Calvary Mater Newcastle Hospital, Newcastle (Australia); Keller, Jacqui; Tripcony, Lee; Dickie, Graeme [Cancer Care Services, Royal Brisbane and Women' s Hospital, Brisbane (Australia); Rischin, Danny [Department of Medical Oncology, Peter MacCallum Cancer Centre, University of Melbourne, Melbourne (Australia); Poulsen, Michael, E-mail: michael_poulsen@health.qld.gov.au [Division of Cancer Services, Princess Alexandra Hospital, University of Queensland, Brisbane (Australia)

    2013-05-01

    Purpose: This study evaluated the impact of margin status and gross residual disease in patients treated with chemoradiation therapy for high-risk stage I and II Merkel cell cancer (MCC). Methods and Materials: Data were pooled from 3 prospective trials in which patients were treated with 50 Gy in 25 fractions to the primary lesion and draining lymph nodes and 2 schedules of carboplatin based chemotherapy. Time to locoregional failure was analyzed according to the burden of disease at the time of radiation therapy, comparing patients with negative margins, involved margins, or macroscopic disease. Results: Analysis was performed on 88 patients, of whom 9 had microscopically positive resection margins and 26 had macroscopic residual disease. The majority of gross disease was confined to nodal regions. The 5-year time to locoregional failure, time to distant failure, time to progression, and disease-specific survival rates for the whole group were 73%, 69%, 62%, and 66% respectively. The hazard ratio for macroscopic disease at the primary site or the nodes was 1.25 (95% confidence interval 0.57-2.77), P=.58. Conclusions: No statistically significant differences in time to locoregional failure were identified between patients with negative margins and those with microscopic or gross residual disease. These results must, however, be interpreted with caution because of the limited sample size.

  20. The prognostic utility of the SYNTAX score on 1-year outcomes after revascularization with zotarolimus- and everolimus-eluting stents: a substudy of the RESOLUTE All Comers Trial

    Garg, Scot; Serruys, Patrick W; Silber, Sigmund

    2011-01-01

    This study assessed the ability of the SYNTAX score (SXscore) to stratify risk in patients treated with percutaneous coronary intervention (PCI) using zotarolimus-eluting or everolimus-eluting stents.......This study assessed the ability of the SYNTAX score (SXscore) to stratify risk in patients treated with percutaneous coronary intervention (PCI) using zotarolimus-eluting or everolimus-eluting stents....

  1. Long-termserial non-invasive multislice computed tomography angiography with functional evaluation after coronary implantation of a bioresorbable everolimus-eluting scaffold: the ABSORB cohort BMSCT substudy

    Onuma, Yoshinobu; Collet, Carlos; van Geuns, Robert-Jan; de Bruyne, Bernard; Christiansen, Evald; Koolen, Jacques; Smits, Pieter; Chevalier, Bernard; McClean, Dougal; Dudek, Dariusz; Windecker, Stephan; Meredith, Ian; Nieman, Koen; Veldhof, Susan; Ormiston, John; Serruys, Patrick W.

    2017-01-01

    Aims Multimodality invasive imaging of the first-in-man cohort demonstrated at 5 years stable lumen dimensions and a low rate of major adverse cardiac events (MACE). However, the long-term non-invasive assessment of this device remains to be documented. The objective was to describe the 72-month

  2. Cytokine profiling in Chagas disease: towards understanding the association with infecting Trypanosoma cruzi discrete typing units (a BENEFIT TRIAL sub-study.

    Cristina Poveda

    Full Text Available Chagas disease caused by the protozoan Trypanosoma cruzi is an important public health problem in Latin America. The immunological mechanisms involved in Chagas disease pathogenesis remain incompletely elucidated. The aim of this study was to explore cytokine profiles and their possible association to the infecting DTU and the pathogenesis of Chagas disease.109 sero-positive T. cruzi patients and 21 negative controls from Bolivia and Colombia, were included. Flow cytometry assays for 13 cytokines were conducted on human sera. Patients were divided into two groups: in one we compared the quantification of cytokines between patients with and without chronic cardiomyopathy; in second group we compared the levels of cytokines and the genetic variability of T. cruzi.Significant difference in anti-inflammatory and pro-inflammatory cytokines profiles was observed between the two groups cardiac and non-cardiac. Moreover, serum levels of IFN-γ, IL-12, IL-22 and IL-10 presented an association with the genetic variability of T.cruzi, with significant differences in TcI and mixed infections TcI/TcII.Expression of anti-inflammatory and pro-inflammatory cytokines may play a relevant role in determining the clinical presentation of chronic patients with Chagas disease and suggests the occurrence of specific immune responses, probably associated to different T. cruzi DTUs.

  3. Cytokine profiling in Chagas disease: towards understanding the association with infecting Trypanosoma cruzi discrete typing units (a BENEFIT TRIAL sub-study).

    Poveda, Cristina; Fresno, Manuel; Gironès, Núria; Martins-Filho, Olindo A; Ramírez, Juan David; Santi-Rocca, Julien; Marin-Neto, José A; Morillo, Carlos A; Rosas, Fernando; Guhl, Felipe

    2014-01-01

    Chagas disease caused by the protozoan Trypanosoma cruzi is an important public health problem in Latin America. The immunological mechanisms involved in Chagas disease pathogenesis remain incompletely elucidated. The aim of this study was to explore cytokine profiles and their possible association to the infecting DTU and the pathogenesis of Chagas disease. 109 sero-positive T. cruzi patients and 21 negative controls from Bolivia and Colombia, were included. Flow cytometry assays for 13 cytokines were conducted on human sera. Patients were divided into two groups: in one we compared the quantification of cytokines between patients with and without chronic cardiomyopathy; in second group we compared the levels of cytokines and the genetic variability of T. cruzi. Significant difference in anti-inflammatory and pro-inflammatory cytokines profiles was observed between the two groups cardiac and non-cardiac. Moreover, serum levels of IFN-γ, IL-12, IL-22 and IL-10 presented an association with the genetic variability of T.cruzi, with significant differences in TcI and mixed infections TcI/TcII. Expression of anti-inflammatory and pro-inflammatory cytokines may play a relevant role in determining the clinical presentation of chronic patients with Chagas disease and suggests the occurrence of specific immune responses, probably associated to different T. cruzi DTUs.

  4. Single versus Serial Measurements of Neuron-Specific Enolase and Prediction of Poor Neurological Outcome in Persistently Unconscious Patients after Out-Of-Hospital Cardiac Arrest - A TTM-Trial Substudy

    Wiberg, Sebastian; Hassager, Christian; Stammet, Pascal

    2017-01-01

    were included from sites participating in the TTM-trial biobank sub study. NSE was measured at 24, 48 and 72 hours after ROSC and follow-up was concluded after 180 days. The primary end point was poor neurological function or death defined by a cerebral performance category score (CPC-score) of 3 to 5...... of the biomarker neuron-specific enolase (NSE) in combination with other predictors of outcome in patients admitted after out-of-hospital cardiac arrest (OHCA). This study sought to investigate the ability of NSE to predict poor outcome in patients remaining unconscious at day three after OHCA. In addition....... RESULTS: A total of 685 (73%) patients participated in the study. At day three after OHCA 63 (9%) patients had died and 473 (69%) patients were not awake. In these patients, a single NSE measurement at 48 hours predicted poor outcome with an area under the receiver operating characteristics curve (AUC...

  5. The Impact of Tai Chi Exercise on Self-Efficacy, Social Support, and Empowerment in Heart Failure: Insights from a Qualitative Sub-Study from a Randomized Controlled Trial.

    Yeh, Gloria Y; Chan, Caroline W; Wayne, Peter M; Conboy, Lisa

    2016-01-01

    To qualitatively explore perceived physical and psychosocial effects and overall patient experience associated with a 12-week tai chi (TC) intervention and an education group in a clinical trial of patients with chronic heart failure (HF). We randomized 100 patients with chronic systolic HF (NYHA Class 1-3, ejection fraction≤40%) to a 12-week group TC program or an education control. At 12-weeks, semi-structured interviews were conducted on a random subset (n = 32; n = 17 in TC, n = 15 in control), audiorecorded and transcribed verbatim. Two independent reviewers extracted information using grounded-theory methods for emergent themes. We explored similarities and differences in themes/sub-themes between the groups, and examined qualitative association with changes from baseline to post-intervention in previously reported quantitative measures (e.g., Minnesota Living with HF, Cardiac Exercise Self Efficacy and Profile of Mood States). The mean age (±SD) of participants was 68±9 years, baseline ejection fraction 29±7%, and median New York Heart Association class 2 HF. We idenitifed themes related to the patient's experience of illness, perceptions of self, and relationship to others. Specific psychosocial and physical benefits were described. Common themes emerged from both groups including: social support and self-efficacy related to activity/exercise and diet. The tai chi group, however, also exhibited a more global empowerment and perceived control. Additional themes in TC included mindfulness/self-awareness, decreased stress reactivity, and renewed social role. These themes mirrored improvements in previously reported quantitative measures (quality-of-life, self-efficacy, and mood) in TC compared to control. Patients in TC also reported physical benefits (e.g., decreased pain, improved energy, endurance, flexibility). Positive themes emerged from both groups, although there were qualitative differences in concepts of self-efficacy and perceived control between groups. Those in tai chi reported not only self efficacy and social support, but overall empowerment with additional gains such as internal locus of control, self-awareness and stress management. Future studies of mind-body exercise might further examine perceived control, self-efficacy, and locus-of-control as potential mediators of effect.

  6. Altered knee joint neuromuscular control during landing from a jump in 10-15 year old children with generalised joint hypermobility. A substudy of the CHAMPS-study Denmark

    Junge, Tina; Juul-Kristensen, B; Bloch Thorlund, Jonas

    Generalised Joint Hypermobility (GJH) is considered an intrinsic risk factor for knee injuries. Knee neuromuscular control during landing may be altered in GJH due to reduced passive stability. The aim was to identify differences in knee neuromuscular control during landing of the Single...... Electrical activity (MVE). There was no difference in jump length between groups. Before landing, GJH had 33% lower Semitendinosus, but 32% higher Gastrocnemius Medialis activity and 39% higher co-contraction of the lateral knee muscles, than controls. After landing, GJH had 36% lower Semitendinosus activity...... than controls, all significant findings. Although the groups performed equally in SLHD, GJH had a Gastrocnemius Medialis-dominated neuromuscular strategy before landing, plausibly caused by reduced Semitendinosus activity. Reduced Semitendinosus activity was seen in GJH after landing...

  7. Altered knee joint neuromuscular control during landing from a jump in 10-15year old children with Generalised Joint Hypermobility. A substudy of the CHAMPS-study Denmark

    Junge, Tina; Wedderkopp, Niels; Thorlund, Jonas Bloch

    2015-01-01

    Generalised Joint Hypermobility (GJH) is considered an intrinsic risk factor for knee injuries. Knee neuromuscular control during landing may be altered in GJH due to reduced passive stability. The aim was to identify differences in knee neuromuscular control during landing of the Single-Leg-Hop-...

  8. Patient-reported outcomes of deferasirox (Exjade, ICL670) versus deferoxamine in sickle cell disease patients with transfusional hemosiderosis. Substudy of a randomized open-label phase II trial.

    Vichinsky, Elliott; Pakbaz, Zahra; Onyekwere, Onyinye; Porter, John; Swerdlow, Paul; Coates, Thomas; Lane, Peter; Files, Beatrice; Mueller, Brigitta U; Coïc, Lena; Forni, Gian Luca; Fischer, Roland; Marks, Peter; Rofail, Diana; Abetz, Linda; Baladi, Jean-Francois

    2008-01-01

    There is increasing evidence demonstrating the value of transfusions in sickle cell disease (SCD). However, resultant iron overload can be life threatening if untreated. Chelation therapy with deferoxamine requires parenteral infusions that can negatively impact quality of life and adherence to treatment. As part of a phase II trial, SCD patient-reported outcomes were evaluated. One hundred and ninety-five patients were randomized (2:1) to receive oral deferasirox (5-30 mg/kg/day) or deferoxamine (20-50 mg/kg, 5 days per week); 121 had previously received deferoxamine. At each time point, significantly more patients who had previously received deferoxamine were 'satisfied/very satisfied' with deferasirox, or found treatment to be 'convenient/very convenient' compared with deferoxamine (p < 0.001). In these patients, fewer hours were lost from daily activities with deferasirox than deferoxamine treatment. Most patients (77%) preferred deferasirox, and more were willing to continue taking deferasirox than deferoxamine at end-of-study (84 vs. 11%, respectively). Patients with SCD are therefore more satisfied with deferasirox, which has a lower impact on daily activities than deferoxamine. Given the high levels of satisfaction, it is likely that quality of life will be improved. These results also suggest that treatment adherence with deferasirox may be better than with deferoxamine, which should lead to improved long-term outcomes. 2008 S. Karger AG, Basel.

  9. Altered knee joint neuromuscular control during landing from a jump in 10-15year old children with Generalised Joint Hypermobility. A substudy of the CHAMPS-study Denmark

    Junge, Tina; Wedderkopp, Niels; Thorlund, Jonas Bloch

    2015-01-01

    Generalised Joint Hypermobility (GJH) is considered an intrinsic risk factor for knee injuries. Knee neuromuscular control during landing may be altered in GJH due to reduced passive stability. The aim was to identify differences in knee neuromuscular control during landing of the Single...... than controls, all significant findings. Although the groups performed equally in SLHD, GJH had a Gastrocnemius Medialis dominated neuromuscular strategy before landing, plausibly caused by reduced Semitendinosus activity. Reduced Semitendinosus activity was seen in GJH after landing...

  10. Altered knee joint neuromuscular control during landing from a jump in 10-15 year old children with Generalised Joint Hypermobility. A substudy of the CHAMPS-study Denmark.

    Junge, Tina; Wedderkopp, Niels; Thorlund, Jonas Bloch; Søgaard, Karen; Juul-Kristensen, Birgit

    2015-06-01

    Generalised Joint Hypermobility (GJH) is considered an intrinsic risk factor for knee injuries. Knee neuromuscular control during landing may be altered in GJH due to reduced passive stability. The aim was to identify differences in knee neuromuscular control during landing of the Single-Leg-Hop-for-Distance test (SLHD) in 25 children with GJH compared to 29 children without GJH (controls), all 10-15years. Inclusion criteria for GJH: Beighton score⩾5/9 and minimum one hypermobile knee. EMG was recorded from the quadriceps, the hamstring and the calf muscles, presented relative to Maximum Voluntary Electrical activity (MVE). There was no difference in jump length between groups. Before landing, GJH had 33% lower Semitendinosus, but 32% higher Gastrocnemius Medialis activity and 39% higher co contraction of the lateral knee muscles, than controls. After landing, GJH had 36% lower Semitendinosus activity than controls, all significant findings. Although the groups performed equally in SLHD, GJH had a Gastrocnemius Medialis dominated neuromuscular strategy before landing, plausibly caused by reduced Semitendinosus activity. Reduced Semitendinosus activity was seen in GJH after landing, but with no compensatory Gastrocnemius Medialis activity. Reduced pre and post-activation of the Semitendinosus may present a risk factor for traumatic knee injuries as ACL ruptures in GJH with knee hypermobility. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  11. Hand bone loss in early rheumatoid arthritis during a methotrexate-based treat-to-target strategy with or without adalimumab-a substudy of the optimized treatment algorithm in early RA (OPERA) trial

    Ørnbjerg, L M; Østergaard, M; Jensen, T

    2017-01-01

    This study aims to investigate 1-year hand bone loss (HBL1-year) in early rheumatoid arthritis (RA) patients treated with a methotrexate (MTX) and intra-articular triamcinolone treat-to-target strategy +/- adalimumab and to determine if HBL6months is associated with radiographic progression after 2...... associated with ∆TSS after 2 years (β = -0.086 (95% confidence interval = -0.15; -0.025) TSS unit/mg/cm(2) increase, p = 0.006) but not with presence of radiographic progression (∆TSS >0) (OR 0.96 (0.92-1.0), p = 0.10). In early RA patients treated with a methotrexate-based treat-to-target strategy...

  12. The Impact of Tai Chi Exercise on Self-Efficacy, Social Support, and Empowerment in Heart Failure: Insights from a Qualitative Sub-Study from a Randomized Controlled Trial.

    Gloria Y Yeh

    Full Text Available To qualitatively explore perceived physical and psychosocial effects and overall patient experience associated with a 12-week tai chi (TC intervention and an education group in a clinical trial of patients with chronic heart failure (HF.We randomized 100 patients with chronic systolic HF (NYHA Class 1-3, ejection fraction≤40% to a 12-week group TC program or an education control. At 12-weeks, semi-structured interviews were conducted on a random subset (n = 32; n = 17 in TC, n = 15 in control, audiorecorded and transcribed verbatim. Two independent reviewers extracted information using grounded-theory methods for emergent themes. We explored similarities and differences in themes/sub-themes between the groups, and examined qualitative association with changes from baseline to post-intervention in previously reported quantitative measures (e.g., Minnesota Living with HF, Cardiac Exercise Self Efficacy and Profile of Mood States.The mean age (±SD of participants was 68±9 years, baseline ejection fraction 29±7%, and median New York Heart Association class 2 HF. We idenitifed themes related to the patient's experience of illness, perceptions of self, and relationship to others. Specific psychosocial and physical benefits were described. Common themes emerged from both groups including: social support and self-efficacy related to activity/exercise and diet. The tai chi group, however, also exhibited a more global empowerment and perceived control. Additional themes in TC included mindfulness/self-awareness, decreased stress reactivity, and renewed social role. These themes mirrored improvements in previously reported quantitative measures (quality-of-life, self-efficacy, and mood in TC compared to control. Patients in TC also reported physical benefits (e.g., decreased pain, improved energy, endurance, flexibility.Positive themes emerged from both groups, although there were qualitative differences in concepts of self-efficacy and perceived control between groups. Those in tai chi reported not only self efficacy and social support, but overall empowerment with additional gains such as internal locus of control, self-awareness and stress management. Future studies of mind-body exercise might further examine perceived control, self-efficacy, and locus-of-control as potential mediators of effect.

  13. Is risk of central nervous system (CNS) relapse related to adjuvant taxane treatment in node-positive breast cancer? Results of the CNS substudy in the intergroup Phase III BIG 02-98 Trial

    Pestalozzi, B.C.; Francis, P.; Quinaux, E.

    2008-01-01

    BACKGROUND: Breast cancer central nervous system (CNS) metastases are an increasingly important problem because of high CNS relapse rates in patients treated with trastuzumab and/or taxanes. PATIENTS AND METHODS: We evaluated data from 2887 node-positive breast cancer patients randomised in the BIG...

  14. Eplerenone survival benefits in heart failure patients post-myocardial infarction are independent from its diuretic and potassium-sparing effects. Insights from an EPHESUS (Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study) substudy

    Rossignol, Patrick; Ménard, Joël; Fay, Renaud

    2011-01-01

    The purpose of this study was to determine whether a diuretic effect may be detectable in patients treated with eplerenone, a mineralocorticoid receptor antagonist, as compared with placebo during the first month of EPHESUS (Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy...

  15. Bone mineral density and inflammatory and bone biomarkers after darunavir-ritonavir combined with either raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults with HIV-1: a substudy of the NEAT001/ANRS143 randomised trial

    Bernardino, Jose I.; Mocroft, Amanda; Mallon, Patrick W.; Wallet, Cedrick; Gerstoft, Jan; Russell, Charlotte; Reiss, Peter; Katlama, Christine; de Wit, Stephane; Richert, Laura; Babiker, Abdel; Buño, Antonio; Castagna, Antonella; Girard, Pierre-Marie; Chene, Genevieve; Raffi, Francois; Arribas, Jose R.; Dedes, Nikos; Allavena, Clotilde; Autran, Brigitte; Antinori, Andrea; Bucciardini, Raffaella; Vella, Stefano; Horban, Andrzej; Arribas, Jose; Babiker, Abdel G.; Boffito, Marta; Pillay, Deenan; Pozniak, Anton; Franquet, Xavier; Schwarze, Siegfried; Grarup, Jesper; Fischer, Aurelie; Diallo, Alpha; Molina, Jean-Michel; Saillard, Juliette; Moecklinghoff, Christiane; Stellbrink, Hans-Jurgen; van Leeuwen, Remko; Gatell, Jose; Sandstrom, Eric; Flepp, Markus; Ewings, Fiona; George, Elizabeth C.; Hudson, Fleur; Pearce, Gillian; Quercia, Romina; Prins, Jan; Wit, Ferdinand W. N. M.; Nieuwkerk, Pythia

    2015-01-01

    Osteopenia, osteoporosis, and low bone mineral density are frequent in patients with HIV. We assessed the 96 week loss of bone mineral density associated with a nucleoside or nucleotide reverse transcriptase inhibitor (NtRTI)-sparing regimen. Antiretroviral-naive adults with HIV were enrolled in 78

  16. N-terminal pro-brain natriuretic peptide for additional risk stratification in patients with non-ST-elevation acute coronary syndrome and an elevated troponin T: an Invasive versus Conservative Treatment in Unstable coronary Syndromes (ICTUS) substudy

    Windhausen, Fons; Hirsch, Alexander; Sanders, Gerard T.; Cornel, Jan Hein; Fischer, Johan; van Straalen, Jan P.; Tijssen, Jan G. P.; Verheugt, Freek W. A.; de Winter, Robbert J.

    2007-01-01

    BACKGROUND: New evidence has emerged that the assessment of multiple biomarkers such as cardiac troponin T (cTnT) and N-terminal pro-brain natriuretic peptide (NT-proBNP) in patients with non-ST-elevation acute coronary syndrome (nSTE-ACS) provides unique prognostic information. The purpose of this

  17. Growth-differentiation factor 15 for long-term prognostication in patients with non-ST-elevation acute coronary syndrome: an Invasive versus Conservative Treatment in Unstable coronary Syndromes (ICTUS) substudy

    Damman, Peter; Kempf, Tibor; Windhausen, Fons; van Straalen, Jan P.; Guba-Quint, Anja; Fischer, Johan; Tijssen, Jan G. P.; Wollert, Kai C.; de Winter, Robbert J.; Hirsch, Alexander

    2014-01-01

    No five-year long-term follow-up data is available regarding the prognostic value of GDF-15. Our aim is to evaluate the long-term prognostic value of admission growth-differentiation factor 15 (GDF-15) regarding death or myocardial infarction (MI) in patients with non-ST-elevation acute coronary

  18. ST-segment deviation on the admission electrocardiogram, treatment strategy, and outcome in non-ST-elevation acute coronary syndromes - A substudy of the Invasive versus Conservative Treatment in Unstable coronary Syndromes (ICTUS) Trial

    Windhausen, Fons; Hirsch, Alexander; Tijssen, Jan G. P.; Cornel, Jan Hein; Verheugt, Freek W. A.; Klees, Margriet I.; de Winter, Robbert J.

    2007-01-01

    Background: We assessed the prognostic significance of the presence of cumulative (Sigma) ST-segment deviation on the admission electrocardiogram (ECG) in patients with non-ST-elevation acute coronary syndrome and an elevated troponin T randomized to a selective invasive (SI) or an early invasive

  19. Long-term efficacy of a combination of amlodipine and olmesartan medoxomil ± hydrochlorothiazide in patients with hypertension stratified by age, race and diabetes status: a substudy of the COACH trial.

    Oparil, S; Chrysant, S G; Melino, M; Lee, J; Karki, S; Heyrman, R

    2010-12-01

    A prespecified subgroup analysis of a 44-week open-label extension study is presented. The efficacy and safety of the combination of amlodipine (AML) + olmesartan medoxomil (OM), with and without the addition of hydrochlorothiazide (HCTZ), were investigated in patients aged ≥65 and <65 years, Blacks and non-Blacks and patients with and without type 2 diabetes. After an 8-week double-blind, placebo-controlled portion of the study, patients initiated therapy on AML 5 + OM 40 mg per day, were uptitrated stepwise to AML 10 + OM 40 mg per day, with the addition of HCTZ 12.5 mg, and 25 mg if blood pressure (BP) goal was not achieved (<140/90 or <130/80 mm Hg for patients with diabetes). Endpoints included the change from baseline in mean seated systolic BP, mean seated diastolic BP and achievement of BP goal. BP decreased from baseline for all treatments in each prespecified subgroup. By the end of the study, BP goal was achieved in 61.0% of patients aged ≥65 years, 68.1% of patients aged <65 years, 63.3% of Blacks, 67.8% of non-Blacks, 26.9% of patients with diabetes and 72.9% of patients without diabetes. The combination of AML + OM ± HCTZ was efficacious, safe and well tolerated by these subgroups.

  20. Clinical significance of late high-degree atrioventricular block in patients with left ventricular dysfunction after an acute myocardial infarction--a Cardiac Arrhythmias and Risk Stratification After Acute Myocardial Infarction (CARISMA) substudy

    Gang, Uffe Jakob Ortved; Jøns, Christian; Jørgensen, Rikke Mørch

    2011-01-01

    High-degree atrioventricular block (HAVB) is a frequent complication in the acute stages of a myocardial infarction associated with an increased rate of mortality. However, the incidence and clinical significance of HAVB in late convalescent phases of an AMI is largely unknown. The aim of this st...... of this study was to assess the incidence and prognostic value of late HAVB documented by continuous electrocardiogram (ECG) monitoring in post-AMI patients with reduced left ventricular function....

  1. Impact of 6-year body weight change on cardiac geometry and function in ageing adults: the SUpplémentation en Vitamines et Minéraux AntioXydants -2 (SU.VI.MAX-2) cardiovascular ultrasound substudy.

    Monsuez, Jean-Jacques; Kesse-Guyot, Emmanuelle; Fezeu, Léopold; Blacher, Jacques; Galan, Pilar; Sebbane, Georges; Hercberg, Serge; Czernichow, Sébastien

    2010-11-01

    Although the relationships between BMI and cardiac geometry and function have been established, information remains limited on the impact of BMI, waist circumference and body composition variations over time on echocardiographic changes in ageing adults. Multiple linear regressions were used to correlate cardiac echographic parameters and baseline anthropometric data and their changes over 6 years in 280 participants of the SU.VI.MAX 2 cohort study. During the follow-up, BMI increased by 0.6 (95% confidence interval: 0.3-0.8) kg/m, waist circumference by 2.3 (1.6-3.0) cm and percentage body fat mass (%BFM) by 4.0 (3.4-4.6) %. A 6-year change (2001-2007) by 1 kg/m in BMI or 1 cm in waist circumference was associated with an increase in indexed left ventricular mass by 2.3 g/m (1.3-3.3, P mass and left atrial area were not impacted by changes in percentage body fat mass. A significant correlation was observed between E-wave transmitral flow deceleration time and baseline BMI and waist circumference, but not with their changes over time. Changes in anthropometric markers over time are associated with increased left ventricular mass and left atrial size. These findings reinforce the potential benefit of a healthy diet and lifestyle to maintain body weight and, in turn, cardiac geometry and function in ageing adults.

  2. Tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent vs. a fluoropolymer-coated everolimus-eluting stent at 13-month follow-up: an optical coherence tomography substudy from the RESOLUTE All Comers trial

    Gutiérrez-Chico, Juan Luis; van Geuns, Robert Jan; Regar, Evelyn

    2011-01-01

    To compare the tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent (ZES) vs. a fluoropolymer-coated everolimus-eluting stent (EES) at 13 months, using optical coherence tomography (OCT) in an 'all-comers' population of patients, in order to clarify the mechanism of eventual...

  3. The Effect of Exit-Site Antibacterial Honey Versus Nasal Mupirocin Prophylaxis on the Microbiology and Outcomes of Peritoneal Dialysis-Associated Peritonitis and Exit-Site Infections: A Sub-Study of the Honeypot Trial.

    Zhang, Lei; Badve, Sunil V; Pascoe, Elaine M; Beller, Elaine; Cass, Alan; Clark, Carolyn; de Zoysa, Janak; Isbel, Nicole M; McTaggart, Steven; Morrish, Alicia T; Playford, E Geoffrey; Scaria, Anish; Snelling, Paul; Vergara, Liza A; Hawley, Carmel M; Johnson, David W

    2015-12-01

    ♦ The HONEYPOT study recently reported that daily exit-site application of antibacterial honey was not superior to nasal mupirocin prophylaxis for preventing overall peritoneal dialysis (PD)-related infection. This paper reports a secondary outcome analysis of the HONEYPOT study with respect to exit-site infection (ESI) and peritonitis microbiology, infectious hospitalization and technique failure. ♦ A total of 371 PD patients were randomized to daily exit-site application of antibacterial honey plus usual exit-site care (N = 186) or intranasal mupirocin prophylaxis (in nasal Staphylococcus aureus carriers only) plus usual exit-site care (control, N = 185). Groups were compared on rates of organism-specific ESI and peritonitis, peritonitis- and infection-associated hospitalization, and technique failure (PD withdrawal). ♦ The mean peritonitis rates in the honey and control groups were 0.41 (95% confidence interval [CI] 0.32 - 0.50) and 0.41 (95% CI 0.33 - 0.49) episodes per patient-year, respectively (incidence rate ratio [IRR] 1.01, 95% CI 0.75 - 1.35). When specific causative organisms were examined, no differences were observed between the groups for gram-positive (IRR 0.99, 95% CI 0.66 - 1.49), gram-negative (IRR 0.71, 95% CI 0.39 - 1.29), culture-negative (IRR 2.01, 95% CI 0.91 - 4.42), or polymicrobial peritonitis (IRR 1.08, 95% CI 0.36 - 3.20). Exit-site infection rates were 0.37 (95% CI 0.28 - 0.45) and 0.33 (95% CI 0.26 - 0.40) episodes per patient-year for the honey and control groups, respectively (IRR 1.12, 95% CI 0.81 - 1.53). No significant differences were observed between the groups for gram-positive (IRR 1.10, 95% CI 0.70 - 1.72), gram-negative (IRR: 0.85, 95% CI 0.46 - 1.58), culture-negative (IRR 1.88, 95% CI 0.67 - 5.29), or polymicrobial ESI (IRR 1.00, 95% CI 0.40 - 2.54). Times to first peritonitis-associated and first infection-associated hospitalization were similar in the honey and control groups. The rates of technique failure (PD withdrawal) due to PD-related infection were not significantly different between the groups. ♦ Compared with standard nasal mupirocin prophylaxis, daily topical exit-site application of antibacterial honey resulted in comparable rates of organism-specific peritonitis and ESI, infection-associated hospitalization, and infection-associated technique failure in PD patients. Copyright © 2015 International Society for Peritoneal Dialysis.

  4. Eplerenone survival benefits in heart failure patients post-myocardial infarction are independent from its diuretic and potassium-sparing effects. Insights from an EPHESUS (Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study) substudy

    Rossignol, Patrick; Ménard, Joël; Fay, Renaud

    2011-01-01

    The purpose of this study was to determine whether a diuretic effect may be detectable in patients treated with eplerenone, a mineralocorticoid receptor antagonist, as compared with placebo during the first month of EPHESUS (Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and S...

  5. Chest Low-Dose Computed Tomography for Early Lung Cancer Diagnosis as an Opportunity to Diagnose Vertebral Fractures in HIV-Infected Smokers, an ANRS EP48 HIV CHEST Substudy.

    Thouvenin, Yann; Makinson, Alain; Cournil, Amandine; Eymard-Duvernay, Sabrina; Lentz, Pierre; Delemazure, Anne-Sophie; Corneloup, Olivier; Fabre, Sylvie; Quesnoy, Mylène; Poire, Sylvain; Brillet, Pierre-Yves; Cyteval, Catherine; Reynes, Jacques; Le Moing, Vincent

    2015-07-01

    To estimate the prevalence of vertebral fractures on chest low-dose computed tomography (LDCT) in HIV-infected smokers. Cross-sectional study of vertebral fractures visualized on chest LDCT from a multicenter prospective cohort evaluating feasibility of chest LDCT for early lung cancer diagnosis in HIV-infected subjects. Subjects were included if 40 years or older, had been active smokers within the last 3 years of at least 20 pack-years, and had a CD4 T-lymphocyte nadir cell count 100 cells per microliter. Spinal reconstructed sagittal planes obtained from chest axial native acquisitions were blindly read by a musculoskeletal imaging specialist. Assessment of the fractured vertebra used Genant semiquantitative method. The study end point was the prevalence of at least 1 vertebral fracture. Three hundred ninety-seven subjects were included. Median age was 49.5 years, median smoking history was 30 pack-years, median last CD4 count was 584 cells per microliter, and median CD4 nadir count was 168 cells per microliter; 90% of subjects had a viral load below 50 copies per milliliter. At least 1 fracture was visible in 46 (11.6%) subjects. In multivariate analysis, smoking ≥40 packs-years [OR = 2.5; 95% CI: (1.2 to 5.0)] was associated with an increased risk of vertebral fracture, while HIV viral load <200 copies per milliliter [OR = 0.3; 95% CI: (0.1 to 0.9)] was protective. Prevalence of vertebral fractures on chest LDCT was 11.6% in this high-risk population. Smoking cessation and early introduction of antiretroviral therapy for prevention of vertebral fractures could be beneficial. Chest LDCT is an opportunity to diagnose vertebral fractures.

  6. Effect of magnesium treatment and glucose levels on delayed cerebral ischemia in patients with subarachnoid hemorrhage : a substudy of the Magnesium in Aneurysmal Subarachnoid Haemorrhage trial (MASH-II)

    Leijenaar, Jolien F.; Mees, Sanne M. Dorhout; Algra, Ale; van den Bergh, Walter M.; Rinkel, Gabriel J. E.

    2015-01-01

    BackgroundMagnesium treatment did not improve outcome in patients with aneurysmal subarachnoid haemorrhage in the Magnesium in Aneurysmal Subarachnoid Haemorrhage II trial. We hypothesized that high glucose levels may have offset a potential beneficial effect to prevent delayed cerebral ischemia. We

  7. Effect of magnesium treatment and glucose levels on delayed cerebral ischemia in patients with subarachnoid hemorrhage : A substudy of the Magnesium in Aneurysmal Subarachnoid Haemorrhage trial (MASH-II)

    Leijenaar, Jolien F.; Dorhout Mees, Sanne M.; Algra, Ale; van den Bergh, Walter M.; Rinkel, Gabriel J. E.

    2015-01-01

    Background: Magnesium treatment did not improve outcome in patients with aneurysmal subarachnoid haemorrhage in the Magnesium in Aneurysmal Subarachnoid Haemorrhage II trial. We hypothesized that high glucose levels may have offset a potential beneficial effect to prevent delayed cerebral ischemia.

  8. Effect of magnesium treatment and glucose levels on delayed cerebral ischemia in patients with subarachnoid hemorrhage: a substudy of the Magnesium in Aneurysmal Subarachnoid Haemorrhage trial (MASH-II).

    Leijenaar, Jolien F; Dorhout Mees, Sanne M; Algra, Ale; van den Bergh, Walter M; Rinkel, Gabriel J E

    2015-10-01

    Magnesium treatment did not improve outcome in patients with aneurysmal subarachnoid haemorrhage in the Magnesium in Aneurysmal Subarachnoid Haemorrhage II trial. We hypothesized that high glucose levels may have offset a potential beneficial effect to prevent delayed cerebral ischemia. We investigated if magnesium treatment led to less delayed cerebral ischemia and if glucose levels interacted with magnesium treatment in the Magnesium in Aneurysmal Subarachnoid Haemorrhage II trial. To investigate the effect of magnesium treatment on occurrence of delayed cerebral ischemia and the interaction between glucose levels and magnesium treatment in subarachnoid hemorrhage patients. The Magnesium in Aneurysmal Subarachnoid Haemorrhage was a phase III randomized placebo-controlled trial assessing the effect of magnesium sulphate on clinical outcome in aneurysmal subarachnoid hemorrhage patients. For the current study, we included only the patients admitted to the University Medical Centre-Utrecht. We calculated hazard ratios for occurrence of delayed cerebral ischemia in patients treated with magnesium vs. placebo for the entire study population, and separately in the subgroups of patients with high and low mean fasting and mean daily glucose levels until onset of delayed cerebral ischemia. We used the cross-product of magnesium and glucose in the regression analysis to evaluate whether an interaction between magnesium and glucose existed. We included 616 patients: 307 received magnesium and 309 placebo; 156 patients had delayed cerebral ischemia. Hazard ratio for magnesium on occurrence of delayed cerebral ischemia was 1·0 (95% confidence interval: 0·7-1·4). Results were similar in patients with low or high fasting or daily glucose levels. We found no interactions between magnesium treatment and high fasting (P = 0·54) and daily glucose (P = 0·60). Magnesium treatment did not reduce the risk of delayed cerebral ischemia in patients with aneurysmal subarachnoid hemorrhage, nor was there an interaction with glucose levels. It is therefore unlikely that glucose levels explain the failure of magnesium to prevent delayed cerebral ischemia and poor outcome after aneurysmal subarachnoid hemorrhage. © 2015 World Stroke Organization.

  9. Effect of Pitavastatin Treatment on ApoB-48 and Lp-PLA₂ in Patients with Metabolic Syndrome: Substudy of PROspective Comparative Clinical Study Evaluating the Efficacy and Safety of PITavastatin in Patients with Metabolic Syndrome.

    Lee, Hyo Sun; Jung, Chang Hee; Kim, Sung Rae; Jang, Hak Chul; Park, Cheol Young

    2016-03-01

    Apolipoprotein (Apo) B-48 is an intestinally derived lipoprotein that is expected to be a marker for cardiovascular disease (CVD). Lipoprotein-associated phospholipase A₂ (Lp-PLA₂) is a vascular-specific inflammatory marker and important risk predictor of CVD. The aim of this study was to explore the effect of pitavastatin treatment and life style modification (LSM) on ApoB-48 and Lp-PLA₂ levels in metabolic syndrome (MS) patients at relatively low risk for CVD, as a sub-analysis of a previous multi-center prospective study. We enrolled 75 patients with MS from the PROPIT study and randomized them into two treatment groups: 2 mg pitavastatin daily+intensive LSM or intensive LSM only. We measured the change of lipid profiles, ApoB-48 and Lp-PLA₂ for 48 weeks. Total cholesterol, low density lipoprotein cholesterol, non-high density lipoprotein cholesterol, and ApoB-100/A1 ratio were significantly improved in the pitavastatin+LSM group compared to the LSM only group (P≤0.001). Pitavastatin+LSM did not change the level of ApoB-48 in subjects overall, but the level of ApoB-48 was significantly lower in the higher mean baseline value group of ApoB-48. The change in Lp-PLA₂ was not significant after intervention in either group after treatment with pitavastatin for 1 year. Pitavastatin treatment and LSM significantly improved lipid profiles, ApoB-100/A1 ratio, and reduced ApoB-48 levels in the higher mean baseline value group of ApoB-48, but did not significantly alter the Lp-PLA₂ levels.

  10. Early math intervention for marginalized students

    Overgaard, Steffen; Tonnesen, Pia Beck

    2016-01-01

    This study is one of more substudies in the project Early Math Intervention for Marginalized Students (TMTM2014). The paper presents the initial process of this substudy that will be carried out fall 2015. In the TMTM2014 project, 80 teachers, who completed a one week course in the idea of TMTM...

  11. Benefits of task-shifting HIV care to nurses in terms of health-related quality of life in patients initiating antiretroviral therapy in rural district hospitals in Cameroon [Stratall Agence Nationale de Recherche sur le SIDA (ANRS) 12110/Ensemble pour une Solidarité Thérapeutique Hospitalière en Réseau (ESTHER) substudy].

    Suzan-Monti, M; Blanche, J; Boyer, S; Kouanfack, C; Delaporte, E; Bonono, R-C; Carrieri, P M; Protopopescu, C; Laurent, C; Spire, B

    2015-05-01

    The World Health Organization (WHO) recommends task-shifting HIV care to nurses in low-resource settings with limited numbers of physicians. However, the effect of such task-shifting on the health-related quality of life (HRQL) of people living with HIV (PLHIV) has seldom been evaluated. We aimed to investigate the effect of task-shifting HIV care to nurses on HRQL outcomes in PLHIV initiating antiretroviral therapy (ART) in rural district hospitals in Cameroon. Outcomes in PLHIV were longitudinally collected in the 2006-2010 Stratall trial. PLHIV were followed up for 24 months by nurses and/or physicians. Six HRQL dimensions were assessed during face-to-face interviews using the WHO Quality of Life (WHOQOL)-HIV BREF scale: physical health; psychological health; independence level; social relationships; environment; and spirituality/religion/personal beliefs. The degree of task-shifting was estimated using a consultant ratio (i.e. the ratio of nurse-led to physician-led visits). The effect of task-shifting and other potential correlates on HRQL dimensions was explored using a Heckman two-stage approach based on linear mixed models to adjust for the potential bias caused by missing data in the outcomes. Of 1424 visits in 440 PLHIV (70.5% female; median age 36 years; median CD4 count 188 cells/μL at enrolment), 423 (29.7%) were task-shifted to nurses. After multiple adjustment, task-shifting was associated with higher HRQL level for four dimensions: physical health [coefficient 0.7; 95% confidence interval (CI) 0.1-1.2; P = 0.01], psychological health (coefficient 0.5; 95% CI 0.0-1.0; P = 0.05), independence level (coefficient 0.6; 95% CI 0.1-1.1; P = 0.01) and environment (coefficient 0.6; 95% CI 0.1-1.0; P = 0.02). Task-shifting HIV care to nurses benefits the HRQL of PLHIV. Together with the previously demonstrated comparable clinical effectiveness of physician-based and nurse-based models of HIV care, our results support the WHO recommendation for task-shifting. © 2015 British HIV Association.

  12. Radiation Therapy Versus No Radiation Therapy to the Neo-breast Following Skin-Sparing Mastectomy and Immediate Autologous Free Flap Reconstruction for Breast Cancer: Patient-Reported and Surgical Outcomes at 1 Year-A Mastectomy Reconstruction Outcomes Consortium (MROC) Substudy.

    Cooke, Andrew L; Diaz-Abele, Julian; Hayakawa, Tom; Buchel, Ed; Dalke, Kimberly; Lambert, Pascal

    2017-09-01

    To determine whether adjuvant radiation therapy (RT) is associated with adverse patient-reported outcomes and surgical complications 1 year after skin-sparing mastectomy and immediate autologous free flap reconstruction for breast cancer. We compared 24 domains of patient-reported outcome measures 1 year after autologous reconstruction between patients who received adjuvant RT and those who did not. A total of 125 patients who underwent surgery between 2012 and 2015 at our institution were included from the Mastectomy Reconstruction Outcomes Consortium study database. Adjusted multivariate models were created incorporating RT technical data, age, cancer stage, estrogen receptor, chemotherapy, breast size, body mass index, and income to determine whether RT was associated with outcomes. At 1 year after surgery, European Organisation for Research and Treatment of Cancer (EORTC) Breast Cancer-Specific Quality of Life Questionnaire breast symptoms were significantly greater in 64 patients who received RT (8-point difference on 100-point ordinal scale, PBREAST-Q (Post-operative Reconstruction Module), Patient-Report Outcomes Measurement Information System Profile 29, McGill Pain Questionnaire-Short Form (MPQ-SF) score, Generalized Anxiety Disorder Scale, and Patient Health Questionnaire-were not statistically different between groups. Surgical complications were uncommon and did not differ by treatment. RT to the neo-breast compared with no RT following immediate autologous free flap reconstruction for breast cancer is well tolerated at 1 year following surgery despite patients undergoing RT also having a higher cancer stage and more intensive surgical and systemic treatment. Neo-breast symptoms are more common in patients receiving RT by the EORTC Breast Cancer-Specific Quality of Life Questionnaire but not by the BREAST-Q. Patient-reported results at 1 year after surgery suggest RT following immediate autologous free flap breast reconstruction is well tolerated. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. Quality of life and patient satisfaction in patients with atrial fibrillation on stable vitamin K antagonist treatment or switched to a non-vitamin K antagonist oral anticoagulant during a 1-year follow-up: A PREFER in AF Registry substudy.

    De Caterina, Raffaele; Brüggenjürgen, Bernd; Darius, Harald; Köhler, Sabine; Lucerna, Markus; Pecen, Ladislav; Renda, Giulia; Schilling, Richard John; Schliephacke, Tessa; Zamorano, José Luis; Le Heuzey, Jean-Yves; Kirchhof, Paulus

    2018-02-01

    Non-vitamin K antagonist oral anticoagulants (NOACs) are being introduced for stroke prevention in non-valvular Atrial Fibrillation (AF), and promise to be accepted better than Vitamin K Antagonists (VKAs) by patients, improving their Quality of Life (QoL). To assess to what extent patient-related factors influence decisions to switch from a VKA to a NOAC. The PREFER in AF Registry collected data at baseline in 2012 - at the beginning of NOAC prescriptions - and at 1-year follow-up, in 6412 patients in seven Western European countries. QoL and patient satisfaction questionnaires (EQ-5D-5L and/or PACT-Q2) were completed in 3777 patients at both visits. Data were compared across categories of patients on stable treatment with a VKA (i.e. continuously over the previous 12 months) (n=2102) or recently switched (within 12 months) from a VKA to a NOAC (n=213) during a 1-year follow-up, allowing a snapshot of factors influencing the switch at a time when NOACs were being introduced into the market. Compared to patients on stable treatment with a VKA, switched patients were similar in terms of age, sex, body mass index and other risk factors, but had lower prevalences of hypertension and heart valve dysfunction, and a lower rate of use of concomitant treatment with antiplatelet/anti-inflammatory agents; they also had a lower CHA 2 DS 2 -VASc score. Among 25 features investigated, switched patients more often reported bruising or bleeding, complained about bruising, were dissatisfied with the anticoagulant treatment, and reported mobility problems and anxiety/depressive traits. At the beginning of NOAC prescriptions, European doctors tended to switch from VKAs to NOACs those patients at lower risk than "non-switchers". Complaints about bruising or bleeding, dissatisfaction with treatment, mobility problems and anxiety/depression traits appear to be related to - and may have influenced - the choice to switch from a VKA to a NOAC. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  14. 78 FR 33095 - Agency Forms Undergoing Paperwork Reduction Act Review

    2013-06-03

    ... various sources (including sodium from processed and restaurant foods, sodium inherent in foods, and salt... collection will include an observational component as well as a sub-study designed to refine the accuracy of...

  15. Sex-related differences in atrial fibrillation: Data from the RACE study

    Rienstra, M.; Van Gelder, I.C.

    2006-01-01

    We evaluated the effects of rate control treatment versus sinus rhythm restoration and maintenance in patients with persistent atrial fibrillation in a substudy of the Rate Control Versus Electrical Cardioversion (RACE) trial. Rhythm control treatment was associated with greater cardiovascular

  16. One-Stop Dispensing

    Houlind, Morten Baltzer; McNulty, Helle Bach Ølgaard; Treldal, Charlotte

    2018-01-01

    (1) Objective: To assess hospital medication costs and staff time between One-Stop Dispensing (OSD) and the Traditional Medication System (TMS), and to evaluate patient perspectives on OSD. (2) Methods: The study was conducted at Hvidovre Hospital, University of Copenhagen, Denmark in an elective...... gastric surgery and acute orthopedic surgery department. This study consists of three sub-studies including adult patients able to self-manage medication. In Sub-study 1, staff time used to dispense and administer medication in TMS was assessed. Medication cost and OSD staff time were collected in Sub......-study 2, while patient perspectives were assessed in Sub-study 3. Medication costs with two days of discharge medication were compared between measured OSD cost and simulated TMS cost for the same patients. Measured staff time in OSD was compared to simulated staff time in TMS for the same patients...

  17. Baseline prevalence and predictors of liver fibrosis among HIV-positive individuals

    Matthews, G V; Neuhaus, J; Bhagani, S

    2015-01-01

    OBJECTIVES: Liver disease is increasingly recognized in HIV-positive individuals, even among those without viral hepatitis, partly as a result of the recent availability of noninvasive methods of liver fibrosis assessment. The objective of this substudy is to compare the effects of early versus...... deferred antiretroviral therapy (ART) on liver fibrosis progression. METHODS: Sites in the Strategic Timing of AntiRetroviral Treatment (START) study with access to FibroScan® were invited to participate in the Liver Fibrosis Progression Substudy. All substudy participants underwent FibroScan® at baseline......, and two noninvasive serum algorithms, APRI and FIB-4, were calculated. Demographic and liver-related information was collected for all START participants at baseline. RESULTS: A total of 230 participants were enrolled in the substudy (11.5% with hepatitis B or C virus coinfection), of whom 221 had a valid...

  18. Development of pedagogical design in technology-rich environments for language teaching and learning

    Jalkanen, Juha

    2015-01-01

    This study explores the development of pedagogical design for language teaching and learning in increasingly technology-rich environments. More specifically, it focuses on the process of design, enactment and analysis of language and literacy pedagogies in technology-rich environments. Two substudies are reported in five articles, each of which approaches pedagogical design from a different perspective. The first substudy examined (a) what pedagogical choices language studen...

  19. Přehled výsledků substudie provedené s uživateli nelegálních psychoaktivních látek a pracovníky zdravotnických zařízení a významnými poskytovateli služeb uživatelům nelegálních drog

    Miovský, Michal; Zábranský, T.

    2001-01-01

    Roč. 1, č. 1 (2001), s. 44-79 ISSN 1213-3841 Institutional research plan: CEZ:AV0Z7025918 Keywords : Illicit psychoactive drug users * service providers * qualitative methods Subject RIV: AN - Psychology

  20. 'Communicate to vaccinate' (COMMVAC. building evidence for improving communication about childhood vaccinations in low- and middle-income countries: protocol for a programme of research

    Lewin Simon

    2011-12-01

    Full Text Available Abstract Background Effective provider-parent communication can improve childhood vaccination uptake and strengthen immunisation services in low- and middle-income countries (LMICs. Building capacity to improve communication strategies has been neglected. Rigorous research exists but is not readily found or applicable to LMICs, making it difficult for policy makers to use it to inform vaccination policies and practice. The aim of this project is to build research knowledge and capacity to use evidence-based strategies for improving communication about childhood vaccinations with parents and communities in LMICs. Methods and design This project is a mixed methods study with six sub-studies. In sub-study one, we will develop a systematic map of provider-parent communication interventions for childhood vaccinations by screening and extracting data from relevant literature. This map will inform sub-study two, in which we will develop a taxonomy of interventions to improve provider-parent communication around childhood vaccination. In sub-study three, the taxonomy will be populated with trial citations to create an evidence map, which will also identify how evidence is linked to communication barriers regarding vaccination. In the project's fourth sub-study, we will present the interventions map, taxonomy, and evidence map to international stakeholders to identify high-priority topics for systematic reviews of interventions to improve parent-provider communication for childhood vaccination. We will produce systematic reviews of the effects of high-priority interventions in the fifth sub-study. In the sixth and final sub-study of the project, evidence from the systematic reviews will be translated into accessible formats and messages for dissemination to LMICs. Discussion This project combines evidence mapping, conceptual and taxonomy development, priority setting, systematic reviews, and knowledge transfer. It will build and share concepts, terms

  1. The influence of time-of-day variation and loading on the aponeurosis plantaris pedis

    Skou, S T; Rathleff, M S; Moelgaard, C M

    2012-01-01

    aponeurosis plantaris pedis thickness was assessed with a 13-MHz linear-array transducer. In sub-study 1, ten participants (ten aponeurosis') were measured five times during 24 hours. In sub-study 2, ten participants (ten aponeurosis') were measured just before, immediately after and again three hours after 3......AIM: The aim of this paper was to investigate the effect of time-of-day on the thickness of the the aponeurosis plantaris pedis, and to examine the acute effects of high-load strength training and long distance running on the thickness of the aponeurosis plantaris pedis. METHODS: Proximal......x12 unilateral heel-rises. In sub-study 3, 11 healthy experienced runners (11 aponeurosis') were measured just before, immediately after and two hours after a 15km run. The average thickness of three scans of each foot was used in the analysis. The data was analysed using repeated measures one...

  2. Om professionella aktörers musikpedagogiska definitionsmakt

    Uddholm, Mats

    2012-01-01

    and conceptualization. In this study this distinction has been crucial to determining the relationship between music education theory and the power of definition as practised in music pedagogy. The research project comprised a background study and three sub-studies. The focus of the background-study was the conditions...... to explore which concepts music-therapists use in their meta-reflections on musical situations in this area of special education. The purpose of the third sub-study was to formulate a theoretical perspective on the relationship between music education theory and the power of definition using Vygotsky......'s hypothesis of semiotic thinking. From the results and conclusions of the sub-studies it is possible to draw two overriding conclusions regarding the research question: first, that music education theory can be understood as a structural coupling between the power of definition that is embedded in music-pedagogical...

  3. Consequences of optional protocol agreements for the Dutch industry. Most important results

    Beumer, L.; Van der Tak, C.M.; Molemaker, R.J.; Melissen, P.; Wilbers, C.A.J.; Van Duyse, P.; Sedee, C.

    1997-01-01

    The study on the title subject comprises several (English) sub-studies in which the environmental and economic consequences of optional international agreements to reduce greenhouse gas emissions are summarized for the Dutch sectors air transport, maritime transport, petrochemical industry, fertilizer industry, and the iron- and steel industry. For the first two sectors the impacts of fuel taxes are analyzed while for the other sectors the effects of energy efficiency measures are analyzed. The appendices contain executive summaries of the English sub-studies. 5 appendices

  4. An investigation into utilising gestational body mass index as a ...

    Objective: The aim of this study was to investigate the ability of the gestational body mass index (BMI) method to screen for adverse birth outcomes and maternal morbidities. Design: This was a substudy of a randomised controlled trial, the Philani Mentor Mothers' study. Setting and subjects: The Philani Mentor Mothers' ...

  5. Pediatric out-of-hospital deaths following hospital discharge: a ...

    Methods: This was a mixed-methods sub-study within a larger cohort study of ... The qualitative analysis identified health seeking behaviors and common ... health knowledge and perceptions of caregivers can be influential to timely access to ..... The sex, age, and HIV status of the child did not appear .... by health workers…

  6. 75 FR 32474 - National Institute of Child Health and Human Development; Revision to Proposed Collection...

    2010-06-08

    ... more streamlined recruitment process; A provider based recruitment strategy that relies on health care... Study (NCS), Vanguard (Pilot) Study, Recruitment Substudy Phase 1 SUMMARY: Under the provisions of... questioned the value and utility of the proposed data collection, stating that this type of research is not...

  7. Intermediate Trends in Math and Science Partnership-Related Changes in Student Achievement with Management Information System Data

    Dimitrov, Dimiter M.

    2009-01-01

    This substudy in the evaluation design of the Math and Science Partnership (MSP) Program Evaluation examines student proficiency in mathematics and science for the MSPs' schools in terms of changes across three years (2003/04, 2004/05, and 2005/06) and relationships with MSP-related variables using Management Information System data with the…

  8. prevalence and predictors of intestinal helminthiasis among school

    Abrham

    2011-11-03

    Nov 3, 2011 ... Gilgel Gibe Hydroelectric Power to determine the prevalence and predictors of intestinal parasitic infections among school children. This study is conducted as sub-study to the main study; the objective of which was to determine the prevalence of intestinal schistosomiasis, and related factors such as risk ...

  9. The effects of intermittent, CD4-guided antiretroviral therapy on body composition and metabolic parameters

    Martinez, Esteban; Visnegarwala, Fehmida; Grund, Birgit; Thomas, Avis; Gibert, Cynthia; Shlay, Judith; Drummond, Fraser; Pearce, Daniel; Edwards, Simon; Reiss, Peter; El-Sadr, Wafaa; Carr, Andrew

    2010-01-01

    Objective: To assess the effects of decreased antiretroviral therapy exposure on body fat and metabolic parameters. Design: Substudy of the Strategies for Management of Anti-Retroviral Therapy study, in which participants were randomized to intermittent CD4-guided [Drug Conservation (DC) group] or

  10. Maternal weight, gestational weight gain and preschool wheezing: The Generation R Study

    E.T.M. Leermakers (Lisan); A.M.M. van der Sonnenschein-Voort (Agnes); R. Gaillard (Romy); A. Hofman (Albert); J.C. de Jongste (Johan); V.W.V. Jaddoe (Vincent); L. Duijts (Liesbeth)

    2013-01-01

    textabstractWe studied the associations of maternal pre-pregnancy body mass index and gestational weight gain with risks of preschool wheezing in offspring and explored the role of growth, infectious and atopic mechanisms. This substudy of 4656 children was embedded in a population-based birth

  11. Impact of Cardiovascular Events on Change in Quality of Life and Utilities in Patients After Myocardial Infarction

    Lewis, Eldrin F; Li, Yanhong; Pfeffer, Marc A

    2014-01-01

    infarction (MI). METHODS: The VALIANT (Valsartan In Acute Myocardial Infarction) trial enrolled 14,703 patients post-MI complicated by Killip class II or higher (scale measuring heart failure severity post-MI ranging from class I to IV) and/or reduced ejection fraction. The HRQL substudy included 2,556 (17...

  12. Dyscalculia ≠ maths difficulties

    Schmidt, Maria Christina Secher

    2015-01-01

    The presentation is based on a substudy conducted in connection with a Danish PhD study of inclusive teaching of beginner mathematics in the Danish municipal primary school and focuses on the research question: What conflicting positions can be identified in relation to low-performing pupils in t...

  13. Associations between personal exposures to VOCs and alterations in cardiovascular physiology: Detroit Exposure and Aerosol Research Study (DEARS) - presentation

    Introduction: An adult cohort consisting of 63 participants engaged in the US EPA’s recent Detroit Exposure and Aerosol Research Study (DEARS) and a University of Michigan cardiovascular sub-study conducted during summer and winter periods over 3 years between 2004 and 2007...

  14. Associations between Personal Exposures to VOCs and Alterations in Cardiovascular Physiology: Detroit Exposure and Aerosol Research Study (DEARS)

    Background: An adult cohort consisting of 63 participants engaged in the US EPA’s recent Detroit Exposure and Aerosol Research Study (DEARS) and a University of Michigan cardiovascular sub-study conducted during summer and winter periods over 3 years between 2004 and 2007 (5 seas...

  15. Admission Hyperglycemia in Critically Ill Sepsis Patients: Association With Outcome and Host Response

    van Vught, Lonneke A.; Wiewel, Maryse A.; Klein Klouwenberg, Peter M. C.; Hoogendijk, Arie J.; Scicluna, Brendon P.; Ong, David S. Y.; Cremer, Olaf L.; Horn, Janneke; Bonten, Marc M. J.; Schultz, Marcus J.; van der Poll, Tom; de Beer, FrisoM; Bos, LieuweD J.; Frencken, JosF; Glas, GerieJ; van Hooijdonk, RoosmarijnT M.; Huson, Michaë laA M.; Schouten, LauraR A.; Straat, Marleen; Witteveen, Esther; Wieske, Luuk

    2016-01-01

    To investigate whether admission hyperglycemia is associated with the presentation and/or outcome of sepsis, what the influence of hyperglycemia is on key host responses to sepsis, and whether hyperglycemia differentially affects patients with diabetes mellitus. A substudy of a prospective

  16. Monitoring Oral Anticoagulant Therapy: Measuring Coagulant Activity

    Attermann, Jorn

    substudy we investigated the fundamental assumptions of the INR system. We found that the data from the comparison of three thromboplastin preparations (CRM 149S, Nycotest and Hepato Quick) were consistent with these assumptions and concluded that the INR system is valid for these thromboplastins...

  17. No prognostic significance of chronic infection with Chlamydia pneumoniae in acute coronary syndromes: insights from the Global Utilization of Strategies to Open Occluded Arteries IV Acute Coronary Syndromes trial

    Westerhout, Cynthia M; Gnarpe, Judy; Chang, Wei-Ching

    2007-01-01

    case-control substudy of the Global Utilization of Strategies to Open Occluded Arteries IV Acute Coronary Syndromes trial, 295 cases (30-day death/myocardial infarction [MI]) were matched by age, sex, baseline creatine kinase-myocardial kinase, and smoking status with 295 control subjects. To test...

  18. Vitamin A-related potential of wild edible plants in a school ...

    This study explored the potential of promoting edible wild plants as source of vitamin A in a resource-limited rural, South African middle-school (grades 7-9) garden, using a mixed method approach of four parallel sub-studies in the rainy season of 2007. Gardening practices in the surrounding community were determined ...

  19. The angiotensin II receptor antagonist telmisartan reduces urinary albumin excretion in patients with isolated systolic hypertension: results of a randomized, double-blind, placebo-controlled trial

    Vogt, Liffert; Navis, Gerjan; Koester, Juergen; Manolis, Athanasios J.; Reid, John L.; de Zeeuw, Dick

    2005-01-01

    Objective To examine the effect of telmisartan or hydrochlorothiazide on the control of urinary albumin excretion (UAE) in patients with isolated systolic hypertension (ISH) unselected for albuminuria in a pre-planned substudy of a large, multicentre, double-blind, placebo-controlled, randomized

  20. The angiotensin II receptor antagonist telmisartan reduces urinary albumin excretion in patients with isolated systolic hypertension: results of a randomized, double-blind, placebo-controlled trial

    Vogt, Liffert; Navis, Gerjan; Köster, Jürgen; Manolis, Athanasios J.; Reid, John L.; de Zeeuw, Dick

    2005-01-01

    To examine the effect of telmisartan or hydrochlorothiazide on the control of urinary albumin excretion (UAE) in patients with isolated systolic hypertension (ISH) unselected for albuminuria in a pre-planned substudy of a large, multicentre, double-blind, placebo-controlled, randomized study. The

  1. Impact of Diabetes, Insulin, and Metformin Use on the Outcome of Patients With Human Epidermal Growth Factor Receptor 2-Positive Primary Breast Cancer

    Sonnenblick, Amir; Agbor-Tarh, Dominique; Bradbury, Ian

    2017-01-01

    in the context of a large, phase III adjuvant trial. Patients and Methods The ALTTO trial randomly assigned patients with HER2-positive breast cancer to receive 1 year of either trastuzumab alone, lapatinib alone, their sequence, or their combination. In this substudy, we evaluated whether patients with diabetes...

  2. Learning-Focused Leadership and Leadership Support: Meaning and Practice in Urban Systems

    Knapp, Michael S.; Copland, Michael A.; Honig, Meredith I.; Plecki, Margaret L.; Portin, Bradley S.

    2010-01-01

    This report synthesizes what has been learned about how leaders in urban systems focus their leadership on the improvement of learning, and what it takes to support their leadership in these settings. The report brings together findings from three sub-study strands, concerned with efforts in seven urban districts to: a) invest staffing and other…

  3. The Netherlands XTC Toxicity (NeXT) study: objectives and methods of a study investigating causality, course, and clinical relevance.

    De Win, Maartje M L; Jager, Gerry; Vervaeke, Hylke K E; Schilt, Thelma; Reneman, Liesbeth; Booij, Jan; Verhulst, Frank C; Den Heeten, Gerard J; Ramsey, Nick F; Korf, Dirk J; Van den Brink, Wim

    2005-01-01

    This paper describes the objectives and methods of The Netherlands XTC Toxicity (NeXT) study focussing on the causality, course, and clinical relevance of ecstasy neurotoxicity. Previous studies suggest that ecstasy (3,4 methylene-dioxymethamphetamine, MDMA, XTC) is toxic toward brain serotonin axons, but most of these studies have serious methodological limitations. The current study is a combination of different approaches with three substudies: (1) a crosssectional substudy among heavy ecstasy users and controls with variation in drug use, which will provide information about potential neurotoxic consequences of ecstasy in relation to other drugs; (2) a prospective cohort substudy in ecstasy-naive subjects with high risk for future ecstasy use, which will provide information on the causality and short-term course of ecstasy use and potential neurotoxicity, and (3) a retrospective cohort substudy in lifetime ecstasy users and matched controls of an existing epidemiological sample that will provide information on long-term course and outcome of ecstasy use in the general population. Neurotoxicity is studied using (a) different imaging techniques (beta-CIT SPECT, 1H-MR spectroscopy, diffusion tensor imaging, perfusion weighted imaging and functional magnetic resonance imaging), and (b) neuropsychological and psychiatric assessments of memory, depression, and personality. The combined results will lead to conclusions that can be used in prevention messages, clinical decision making, and the development of an (inter)national ecstasy policy.

  4. Predictive value of NGAL for use of renal replacement therapy in patients with severe sepsis

    Hjortrup, P B; Haase, N; Treschow, F

    2015-01-01

    intensive care units (ICUs) in adult ICU patients with severe sepsis needing fluid resuscitation and a sub-study of the 6S trial. Plasma and urine were sampled at baseline and NGAL was measured using particle-enhanced turbidimetric immunoassay (The NGAL Test). Outcome measures were use of RRT in ICU...

  5. Skin autofluorescence as proxy of tissue AGE accumulation is dissociated from SCORE cardiovascular risk score, and remains so after 3 years

    Tiessen, Ans H.; Jager, Willemein; ter Bogt, Nancy C. W.; Beltman, Frank W.; van der Meer, Klaas; Broer, Jan; Smit, Andries J.

    Background: Skin autofluorescence (SAF), as a proxy of AGE accumulation, is predictive of cardiovascular (CVD) complications in i.a. type 2 diabetes mellitus and renal failure, independently of most conventional CVD risk factors. The present exploratory substudy of the Groningen Overweight and

  6. Biomarkers and low risk in heart failure. Data from COACH and TRIUMPH

    Meijers, Wouter C.; de Boer, Rudolf A.; van Veldhuisen, Dirk J.; Jaarsma, Tiny; Hillege, Hans L.; Maisel, Alan S.; Di Somma, Salvatore; Voors, Adriaan A.; Peacock, W. Frank

    2015-01-01

    AimTraditionally, risk stratification in heart failure (HF) emphasizes assessment of high risk. We aimed to determine if biomarkers could identify patients with HF at low risk for death or HF rehospitalization. Methods and resultsThis analysis was a substudy of The Coordinating Study Evaluating

  7. Effect of Spironolactone on 30-Day Death and Heart Failure Rehospitalization (from the COACH Study)

    Maisel, Alan; Xue, Yang; van Veldhuisen, Dirk J.; Voors, Adriaan A.; Jaarsma, Tiny; Pang, Peter S.; Butler, Javed; Pitt, Bertram; Clopton, Paul; de Boer, Rudolf A.

    2014-01-01

    The aim of our study is to investigate the effect of spironolactone on 30-day outcomes in patients with acute heart failure (AHF) and the association between treatment and outcomes stratified by biomarkers. We conducted a secondary analysis of the biomarker substudy of the multicenter COACH

  8. Surrealist's Dreams and Classical Tradition

    Bažant, Jan

    2015-01-01

    Roč. 48, č. 1 (2015), s. 82-94 ISSN 0044-9008 Institutional support: RVO:67985955 Keywords : Medusa * snakes * surrealism Subject RIV: AB - History http://www.dejum.sav.sk/?language=sk§ion=magazine&id=98&textId=590&sub=study

  9. Prediction of clinical outcome by myocardial CT perfusion in patients with low-risk unstable angina pectoris

    Linde, Jesper J; Sørgaard, Mathias; Kühl, Jørgen T

    2017-01-01

    The prognostic implications of myocardial computed tomography perfusion (CTP) analyses are unknown. In this sub-study to the CATCH-trial we evaluate the ability of adenosine stress CTP findings to predict mid-term major adverse cardiac events (MACE). In 240 patients with acute-onset chest pain, y...

  10. Intra-Cultural Variation in Child Care Practices in Japan

    Toyama, Noriko

    2016-01-01

    This study, comprising three sub-studies, aims to examine how child-rearing practices vary according to different social circumstances in Japan. By comparing teacher-child interaction at mealtimes in day care centres both on an isolated small island located in Okinawa prefecture, Tarama, and in a large industrialised city, Tokyo, the following was…

  11. Women's preferences of dynamic spectral imaging colposcopy

    Louwers, J.A.; Zaal, Afra; Kocken, M.; Papagiannakis, E.; Meijer, C.J.; Verheijen, RHM

    2015-01-01

    Background: The focus of testing the dynamic spectral imaging (DSI) colposcope has been on the technical characteristics and clinical performance. However, aspects from a patient’s perspective are just as important. Methods: This study was designed as a substudy of the DSI validation study, a

  12. Effect of extended follow-up in a specialized heart failure clinic on adherence to guideline recommended therapy

    Schou, Morten; Gislason, Gunnar; Videbaek, Lars

    2014-01-01

    AIMS: The optimal duration of a public heart failure (HF) clinic programme is unknown. This substudy of the NT-proBNP stratified follow-up in outpatient heart failure clinics (NorthStar) trial was designed to evaluate the effect of extended follow-up in an outpatient HF clinic on long...

  13. Rate control is more cost-effective than rhythm control for patients with persistent atrial fibrillation - results from the RAte Control versus Electrical cardioversion (RACE) study

    Hagens, VE; Vermeulen, KM; TenVergert, EM; Van Veldhuisen, JGP; Bosker, HA; Kamp, O; Kingma, JH; Tijssen, JGP; Crijns, HJGM; Van Gelder, IC

    Aims To evaluate costs between a rate and rhythm control strategy in persistent atrial. fibrillation. Methods and results In a prospective substudy of RACE (Rate control versus electrical cardioversion for persistent atrial. fibrillation) in 428 of the total 522 patients (206 rate control and 222

  14. Impact of HPV vaccination with Gardasil® in Switzerland.

    Jacot-Guillarmod, Martine; Pasquier, Jérôme; Greub, Gilbert; Bongiovanni, Massimo; Achtari, Chahin; Sahli, Roland

    2017-12-22

    Gardasil®, a quadrivalent vaccine targeting low-risk (6, 11) and high-risk (16, 18) human papillomaviruses (HPV), has been offered to 11-14 year-old schoolgirls in Switzerland since 2008. To evaluate its success and its potential impact on cervical cancer screening, HPV genotypes were examined in 18-year-old girls five years later (sub-study 1) and in outpatients participating to cervical cancer screening before and after vaccine implementation (sub-study 2). For sub-study 1, 3726 females aged 18 in 2013 were invited to fill a questionnaire on personal demographics and HPV risk factors and to provide a self-collected cervicovaginal sample for HPV genotyping and Chlamydia trachomatis PCR. Personal data were evaluated by univariable and multivariable statistics. In sub-study 2, the proportion of the vaccine-type HPV among anogenital HPV was examined with archived genotyping data of 8039 outpatients participating to cervical cancer screening from 1999 till 2015. The yearly evolution of this proportion was evaluated by segmented logistic regression. 690 (18.5%) women participated to sub-study 1 and 327 (8.8%) provided a self-collected sample. Prevalence of Chlamydia trachomatis (4.6%) and demographics confirmed that the subjects were representative of sexually-active Swiss young women. Vaccine (five-year coverage: 77.5%) was preferentially accepted by contraceptive-pill users (P = 0.001) and samples were mainly provided by sexually-active subjects (P Switzerland. Our data suggest that cervical cancer screening is now entering a stage of reduced proportion of HPV16 and/or 18 in samples reported positive by cytology. In view of the high likelihood of reduced clinical specificity of cytology, primary screening modalities involving HPV testing and cytology should now be re-evaluated in Switzerland.

  15. Does vital exhaustion increase the risk of type 2 diabetes?

    Volden, Sasia; Wimmelmann, Cathrine Lawaetz; Flensborg-Madsen, Trine

    2017-01-01

    Hospital Discharge Register to detect registrations with type 2 diabetes until 2014. Results: A high degree of VE was associated with an increased risk of developing type 2 diabetes in both substudies. In the first substudy, the OR for developing type 2 diabetes was 2.56 (95% CI, 1.53; 4,29, P ...Background: There is evidence that both stress and depression have a causal relationship with type 2 diabetes suggesting that vital exhaustion (VE) too could be a risk factor. The association between VE and type 2 diabeteshas, however, not been investigated prospectively. Aim: To prospectively...... investigate whether VE is associated with an increased risk of type 2 diabetes in a Danish population. Methods: A prospective cohort study based on the Copenhagen City Heart Study (1991–1993). The degree of VE was measured among 9075 participants without type 1 or 2 diabetes at baseline. To detect type 2...

  16. Validation of the omega-3 fatty acid intake measured by a web-based food frequency questionnaire against omega-3 fatty acids in red blood cells in men with prostate cancer.

    Allaire, J; Moreel, X; Labonté, M-È; Léger, C; Caron, A; Julien, P; Lamarche, B; Fradet, V

    2015-09-01

    The objective of this study was to evaluate the ability of a web-based self-administered food frequency questionnaire (web-FFQ) to assess the omega-3 (ω-3) fatty acids (FAs) intake of men affected with prostate cancer (PCa) against a biomarker. The study presented herein is a sub-study from a phase II clinical trial. Enrolled patients afflicted with PCa were included in the sub-study analysis if the FA profiles from the red blood cell (RBC) membranes and FA intakes at baseline were both determined at the time of the data analysis (n=60). Spearman's correlation coefficients were calculated to estimate the correlations between FA intakes and their proportions in the RBC membranes. Intakes of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) were highly correlated with their respective proportions in the RBC membranes (both rs=0.593, Pstudies carried out in men with PCa.

  17. The Musician, the Researcher and the Psychologist

    Uddholm, Mats

    practice. In contrast, the results indicate that the force contained in music-theoretical concepts appears to have an impact on how music situations are interpreted. These diversities were expressed as three different types of music-therapists; the Musician, the Researcher and the Psychologist, which......The Musician, the Researcher and the Psychologist The aim of this presentation is to illuminate and discuss some connections between the therapeutic profession and development of music pedagogic theory. A topic that initially emerged as a result of a sub-study in my PhD -project about professional...... practitioners music-pedagogical Powers of Definition. The purpose of this sub-study was to generate data about which concepts music-therapists use in their meta-reflections on musical situations in special-pedagogic related practices. The link between the sub-study’s results and the research question was based...

  18. Migrants' access to healthcare

    Norredam, Marie

    2011-01-01

    There are strong pragmatic and moral reasons for receiving societies to address access to healthcare for migrants. Receiving societies have a pragmatic interest in sustaining migrants' health to facilitate integration; they also have a moral obligation to ensure migrants' access to healthcare...... according to international human rights principles. The intention of this thesis is to increase the understanding of migrants' access to healthcare by exploring two study aims: 1) Are there differences in migrants' access to healthcare compared to that of non-migrants? (substudy I and II); and 2) Why...... are there possible differences in migrants' access to healthcare compared to that of non-migrants? (substudy III and IV). The thesis builds on different methodological approaches using both register-based retrospective cohort design, cross-sectional design and survey methods. Two different measures of access were...

  19. A school meal study: comparing platewaste and likings of packed lunch and school lunch based on the New Nordic Diet

    Thorsen, Anne Vibeke; Lassen, Anne Dahl; Christensen, Lene M.

    2013-01-01

    Background and objectives: The majority of Danish children do not eat in accordance with the national dietary guidelines. The OPUS School Meal Study is a school-based intervention study testing the health effects of the New Nordic Diet (NND). The aim of this sub-study was to compare edible plate.......0; 119.0). Lunches rated as ‘really bad’ or ‘bad’ in the self-reported likings had more waste than lunches rated ‘really good’ (P ... schools were assigned to the food waste sub-study. Edible plate waste was measured by weighing individually the meal for 5 consecutive days before and after lunch at the end of each dietary period. Self-reported smiley ratings from a web-based dietary assessment software for children were compared...

  20. Rationale and Design for the Peripartum Cardiomyopathy in Nigeria (PEACE Registry

    Kamilu M Karaye

    2017-01-01

    Full Text Available Background Nigeria probably has the highest burden of Peripartum Cardiomyopathy (PPCM in the world. The primary objective of this study is to describe the burden, ventricular remodelling and survival of PPCM in Nigeria. In the sub-studies, we aim to describe the relationship between selenium deficiency, oxidative stress and PPCM, the impact of sodium selenite supplementation on left ventricular reverse remodelling, change in New York Heart Association functional class and survival in PPCM, and the prevalence of selenium deficiency and its relationship with cardiac function in apparently healthy pregnant women. Methods The main registry and the first sub-study are prospective longitudinal studies, while the second sub-study is an open-label randomised trial. 36 study centres across Nigeria have been registered and 14 of them are already recruiting subjects. Patients will be recruited from June to December 2017 and followed up till December 2018. Serum selenium and glutathione peroxidase will be assayed at recruitment for consecutive PPCM patients with LV ejection fraction (LVEF <45% at 6 months postpartum. 200 subjects with selenium deficiency will be randomised into treatment (Selenium Selenite 200μg tablets daily for 3 months and no-treatment arms. In the second sub-study, 120 apparently healthy pregnant women (Controls will be recruited at 28-38 weeks of gestation and reviewed at 6-8 weeks postpartum, and their serum selenium and GPO levels will be measured at recruitment. Conclusions This will be the largest systematic evaluation of PPCM in Nigeria, and it is hoped that the information will assist in understanding the disease better and developing locally applicable interventions for the disease. ClinicalTrials.gov Identifier: NCT03081949

  1. Theory of Reasoned Action and the role of external factors in organic food purchase

    Myresten, Emma; Setterhall, Mikaela

    2015-01-01

    This study examines a current phenomenon and behavioural shift amongst consumers’, namely the accelerating growth of organic food sales in Sweden. By combining the Theory of Reasoned Action (TRA), with the logic of value co-creation, an appropriate research tool has been developed stemmed from two related sub-studies. Based on TRA’s argument that additional factors, referred to as external, only can influence behavioural intention indirectly, combined with the proposed impact of value co-crea...

  2. Developing a Digital Medicine System in Psychiatry: Ingestion Detection Rate and Latency Period.

    Profit, Deborah; Rohatagi, Shashank; Zhao, Cathy; Hatch, Ainslie; Docherty, John P; Peters-Strickland, Timothy S

    2016-09-01

    A digital medicine system (DMS) has been developed to measure and report adherence to an atypical antipsychotic, aripiprazole, in psychiatric patients. The DMS consists of 3 components: ingestible sensor embedded in a medication tablet, wearable sensor, and secure mobile and cloud-based applications. An umbrella study protocol was designed to rapidly assess the technical performance and safety of the DMS in multiple substudies to guide the technology development. Two sequential substudies enrolled 30 and 29 healthy volunteers between March-April 2014 and February-March 2015, respectively, to assess detection accuracy of the ingestible sensor by the DMS and the latency period between ingestion and detection of the ingestion by the wearable sensor or the cloud-based server. The first substudy identified areas for improvement using early versions of the wearable sensor and the mobile application. The second substudy tested updated versions of the components and showed an overall ingestion detection rate of 96.6%. Mean latency times for the signal transmission were 1.1-1.3 minutes (from ingestion to the wearable sensor detection) and 6.2-10.3 minutes (from the wearable sensor detection to the server detection). Half of transmissions were completed in < 2 minutes, and ~90% of ingestions were registered by the smartphone within 30 minutes of ingestion. No serious adverse events, discontinuations, or clinically significant laboratory/vital signs findings were reported. The DMS implementing modified versions of the smartphone application and the wearable sensor has the technical capability to detect and report tablet ingestion with high accuracy and acceptable latency time. ClinicalTrials.gov identifier: NCT02091882. © Copyright 2016 Physicians Postgraduate Press, Inc.

  3. Heliox Improves Carbon Dioxide Removal during Lung Protective Mechanical Ventilation

    Beurskens, Charlotte J; Brevoord, Daniel; Lagrand, Wim K; van den Bergh, Walter M; Vroom, Margreeth B; Preckel, Benedikt; Horn, Janneke; Juffermans, Nicole P

    2014-01-01

    Introduction. Helium is a noble gas with low density and increased carbon dioxide (CO2) diffusion capacity. This allows lower driving pressures in mechanical ventilation and increased CO2 diffusion. We hypothesized that heliox facilitates ventilation in patients during lung-protective mechanical ventilation using low tidal volumes. Methods. This is an observational cohort substudy of a single arm intervention study. Twenty-four ICU patients were included, who were admitted after a cardiac arr...

  4. Acceptability and feasibility of repeated mucosal specimen collection in clinical trial participants in Kenya.

    Gloria Omosa-Manyonyi

    Full Text Available Mucosal specimens are essential to evaluate compartmentalized immune responses to HIV vaccine candidates and other mucosally targeted investigational products. We studied the acceptability and feasibility of repeated mucosal sampling in East African clinical trial participants at low risk of HIV and other sexually transmitted infections.The Kenya AIDS Vaccine Initiative (KAVI enrolled participants into three Phase 1 trials of preventive HIV candidate vaccines in 2011-2012 at two clinical research centers in Nairobi. After informed consent to a mucosal sub-study, participants were asked to undergo collection of mucosal secretions (saliva, oral fluids, semen, cervico-vaginal and rectal, but could opt out of any collection at any visit. Specimens were collected at baseline and two additional time points. A tolerability questionnaire was administered at the final sub-study visit. Of 105 trial participants, 27 of 34 women (79% and 62 of 71 men (87% enrolled in the mucosal sub-study. Nearly all sub-study participants gave saliva and oral fluids at all visits. Semen was collected from about half the participating men (47-48% at all visits. Cervico-vaginal secretions were collected by Softcup from about two thirds of women (63% at baseline, increasing to 78% at the following visits, with similar numbers for cervical secretion collection by Merocel sponge; about half of women (52% gave cervico-vaginal samples at all visits. Rectal secretions were collected with Merocel sponge from about a quarter of both men and women (24% at all 3 visits, with 16% of men and 19% of women giving rectal samples at all visits.Repeated mucosal sampling in clinical trial participants in Kenya is feasible, with a good proportion of participants consenting to most sampling methods with the exception of rectal samples. Experienced staff members of both sexes and trained counselors with standardized messaging may improve acceptance of rectal sampling.

  5. Coronary plaque quantification and fractional flow reserve by coronary computed tomography angiography identify ischaemia-causing lesions

    Gaur, Sara; Øvrehus, Kristian Altern; Dey, Damini

    2016-01-01

    AIMS: Coronary plaque characteristics are associated with ischaemia. Differences in plaque volumes and composition may explain the discordance between coronary stenosis severity and ischaemia. We evaluated the association between coronary stenosis severity, plaque characteristics, coronary computed...... tomography angiography (CTA)-derived fractional flow reserve (FFRCT), and lesion-specific ischaemia identified by FFR in a substudy of the NXT trial (Analysis of Coronary Blood Flow Using CT Angiography: Next Steps). METHODS AND RESULTS: Coronary CTA stenosis, plaque volumes, FFRCT, and FFR were assessed...

  6. Distributed leadership in Finnish and Shanghai schools

    Tian, Meng

    2016-01-01

    The present research employed mixed-methods approach to further theorise distributed leadership and to investigate its manifestations in Finnish and Shanghai schools. The whole research comprised two phases. The first phase contained a meta-analysis (Sub-study I), which systematically reviewed 85 key distributed leadership articles published between 2002 and 2013. The meta-analysis identified two main research paradigms: the descriptive-analytical paradigm and the prescrip...

  7. Music Production with Changing Tools – a Challenge to Formal Education

    Gullö, Jan-Olof

    2010-01-01

    The Millennials, today’s pupils and students, is the first generation to grow up with tools for interactive communication and media production. Many students choose to study music production in higher education establishments. Therefore music production is an emerging subject and important research topic. The aim of this thesis is to develop knowledge of music production and to identify key skills necessary for music producers and music production teachers. Three sub-studies were performed to...

  8. Preliminary open-label clinical evaluation of the soothing and reepithelialization properties of a novel topical formulation for rosacea

    Sparavigna A

    2014-10-01

    Full Text Available Adele Sparavigna, Beatrice Tenconi, Ileana De Ponti Derming Srl, Monza, Italy Background: Rosacea is a common, incurable skin barrier disorder characterized by relapses and remissions. Purpose: To evaluate the efficacy of Farmaka Rosacea Cream (FRC, a novel topical formulation for rosacea. Methods: This single-center, open-label pilot study comprised a single-dose substudy in 20 healthy subjects and a long-term, repeat-dose substudy in 22 subjects with rosacea. The 2-hour, controlled, single-dose substudy assessed the soothing and reepithelialization properties of FRC after stripping-induced erythema based on the erythema index, transepidermal water loss, skin hydration, and clinical assessments of erythema. In the long-term substudy, subjects applied FRC twice daily for 8 weeks. Clinical assessments included vascular and pigmentary homogeneity and erythema and hemoglobin indices. Subjects completed questionnaires to assess FRC efficacy and cosmetic acceptability. Results: Greater reductions were seen in FRC-treated areas compared with untreated areas for the erythema index (-16% versus -8%; P<0.001 and mean transepidermal water loss (-35.8% versus -10.1%; P<0.001 30 minutes after stripping. Significant improvements over untreated areas were maintained 2 hours after stripping. Skin hydration and clinical erythema assessments also indicated that FRC soothed rosacea symptoms and promoted skin reepithelialization. Erythema and hemoglobin indices were significantly reduced from baseline after 4 and 8 weeks of treatment. Clinically assessed parameters were significantly improved following FRC application. Subjects assessed FRC positively. Conclusion: Improvement of rosacea symptoms was noted with FRC application. The main film-forming ingredients of FRC (trehalose, cholesterol, ceramide, and fatty acids, combined with other soothing and calming ingredients and ultraviolet filters, could explain its efficacy. Keywords: rosacea, erythema, skin

  9. Nurse-Led Intervention to Improve Knowledge of Medications in Survivors of Stroke or Transient Ischemic Attack: A Cluster Randomized Controlled Trial

    Olaiya, Muideen T.; Cadilhac, Dominique A.; Kim, Joosup; Ung, David; Nelson, Mark R.; Srikanth, Velandai K.; Bladin, Christopher F.; Gerraty, Richard P.; Fitzgerald, Sharyn M.; Phan, Thanh G.; Frayne, Judith; Thrift, Amanda G.

    2016-01-01

    Introduction Limited evidence exists on effective interventions to improve knowledge of preventive medications in patients with chronic diseases, such as stroke. We investigated the effectiveness of a nurse-led intervention, where a component was to improve knowledge of prevention medications, in patients with stroke or transient ischemic attack (TIA). Methods Prospective sub-study of the Shared Team Approach between Nurses and Doctors for Improved Risk Factor Management, a randomi...

  10. Nurse-led intervention to improve knowledge of medications in survivors of stroke or transient ischemic attack: a cluster randomized controlled trial

    Muideen Olaiya; Dominique Cadilhac; Dominique Cadilhac; Joosup Kim; Joosup Kim; David Ung; Mark Raymond Nelson; Mark Raymond Nelson; Velandai Srikanth; Velandai Srikanth; Christopher Bladin; Richard Gerraty; Sharyn Fitzgerald; THANH G PHAN; Judith Frayne

    2016-01-01

    Introduction: Limited evidence exists on effective interventions to improve knowledge of preventive medications in patients with chronic diseases, such as stroke. We investigated the effectiveness of a nurse-led intervention, where a component was to improve knowledge of prevention medications, in patients with stroke or transient ischemic attack (TIA).Methods: Prospective sub-study of the Shared Team Approach between Nurses and Doctors For Improved Risk Factor Management (STAND FIRM), a rand...

  11. Circulating irisin in healthy, young individuals: day-night rhythm, effects of food intake and exercise, and associations with gender, physical activity, diet, and body composition.

    Anastasilakis, Athanasios D; Polyzos, Stergios A; Saridakis, Zacharias G; Kynigopoulos, Georgios; Skouvaklidou, Elpida C; Molyvas, Dimitrios; Vasiloglou, Maria F; Apostolou, Aggeliki; Karagiozoglou-Lampoudi, Thomai; Siopi, Aikaterina; Mougios, Vassilis; Chatzistavridis, Panagiotis; Panagiotou, Grigorios; Filippaios, Andreas; Delaroudis, Sideris; Mantzoros, Christos S

    2014-09-01

    The myokine irisin may increase energy expenditure and affect metabolism. The objective of the study was to elucidate predictors of irisin and study whether circulating irisin may have day-night rhythm in humans. This was an observational, cross-sectional study with an additional 24-hour prospective observational arm (day-night rhythm substudy) and two prospective interventional arms (mixed meal substudy and exercise substudy). The study was conducted at the Hellenic Military School of Medicine (Thessaloniki, Greece). One hundred twenty-two healthy, young individuals were subjected to anthropometric and body composition measurements, and their eating and exercise behavior profiles were assessed with validated questionnaires. Subgroups were subjected to day-night rhythm, standardized meal ingestion, and 30-minute aerobic exercise studies. Circulating irisin levels were measured. Ιrisin levels were lower in males than females (P = .02) after adjustment for lean body mass, which was its major determinant. Irisin levels followed a day-night rhythm (P day-night rhythm, is correlated with lean body mass, and increases acutely after exercise.

  12. [Study protocol on the effect of the economic crisis on mortality and reproductive health and health inequalities in Spain].

    Pérez, Glòria; Gotsens, Mercè; Palència, Laia; Marí-Dell'Olmo, Marc; Domínguez-Berjón, M Felicitas; Rodríguez-Sanz, Maica; Puig, Vanessa; Bartoll, Xavier; Gandarillas, Ana; Martín, Unai; Bacigalupe, Amaia; Díez, Elia; Ruiz, Miguel; Esnaola, Santiago; Calvo, Montserrat; Sánchez, Pablo; Luque Fernández, Miguel Ángel; Borrell, Carme

    The aim is to present the protocol of the two sub-studies on the effect of the economic crisis on mortality and reproductive health and health inequalities in Spain. Substudy 1: describe the evolution of mortality and reproductive health between 1990 and 2013 through a longitudinal ecological study in the Autonomous Communities. This study will identify changes caused by the economic crisis in trends or reproductive health and mortality indicators using panel data (17 Autonomous Communities per study year) and adjusting Poisson models with random effects variance. Substudy 2: analyse inequalities by socioeconomic deprivation in mortality and reproductive health in several areas of Spain. An ecological study analysing trends in the pre-crisis (1999-2003 and 2004-2008) and crisis (2009-2013) periods will be performed. Random effects models Besag York and Mollié will be adjusted to estimate mortality indicators softened in reproductive health and census tracts. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

  13. Auditory extinction and dichotic listening cv task in cerebral infarction preliminary report

    Mauro Muszkat

    1990-06-01

    Full Text Available Six stroke patients were studied using a dichotic listening¹ CV task, 4 with left hemisphere infarction, 2 with right hemisphere infarction. It was observed a «lesion--effect», a shift of hemisphere prevalence to the side opposite a brain lesion. The authors suggest that the lesion-effect can be explained by the auditory extinction phenomenon at the linguistic level.

  14. Relationship between extent of brain hypoperfused area and functional outcome in patients with a small subcortical infarction

    Isaka, Yoshinari; Imaizumi, Masatoshi; Ashida, Keiichi; Nakayama, Hirofumi; Iiji, Osamu; Itoi, Yoshihito; Furukawa, Toshiyuki

    1992-01-01

    We performed 123 I-IMP single photon emission computed tomography (SPECT) in 43 patients who had a small infarction ( 2 =29.3; p 123 I-IMP SPECT in patients with a small infarction may discriminate lacunar infarction from embolic or hemodynamic infarction, which was caused by vascular lesions of major cerebral arteries, in subcortical area. Our study suggests that functional outcome is better in lacunar infarction than embolic or hemodynamic infarction in subcortical area. (author)

  15. Use of a Novel Artificial Intelligence Platform on Mobile Devices to Assess Dosing Compliance in a Phase 2 Clinical Trial in Subjects With Schizophrenia.

    Bain, Earle E; Shafner, Laura; Walling, David P; Othman, Ahmed A; Chuang-Stein, Christy; Hinkle, John; Hanina, Adam

    2017-02-21

    Accurately monitoring and collecting drug adherence data can allow for better understanding and interpretation of the outcomes of clinical trials. Most clinical trials use a combination of pill counts and self-reported data to measure drug adherence, despite the drawbacks of relying on these types of indirect measures. It is assumed that doses are taken, but the exact timing of these events is often incomplete and imprecise. The objective of this pilot study was to evaluate the use of a novel artificial intelligence (AI) platform (AiCure) on mobile devices for measuring medication adherence, compared with modified directly observed therapy (mDOT) in a substudy of a Phase 2 trial of the α7 nicotinic receptor agonist (ABT-126) in subjects with schizophrenia. AI platform generated adherence measures were compared with adherence inferred from drug concentration measurements. The mean cumulative pharmacokinetic adherence over 24 weeks was 89.7% (standard deviation [SD] 24.92) for subjects receiving ABT-126 who were monitored using the AI platform, compared with 71.9% (SD 39.81) for subjects receiving ABT-126 who were monitored by mDOT. The difference was 17.9% (95% CI -2 to 37.7; P=.08). Using drug levels, this substudy demonstrates the potential of AI platforms to increase adherence, rapidly detect nonadherence, and predict future nonadherence. Subjects monitored using the AI platform demonstrated a percentage change in adherence of 25% over the mDOT group. Subjects were able to use the technology successfully for up to 6 months in an ambulatory setting with early termination rates that are comparable to subjects outside of the substudy. ClinicalTrials.gov NCT01655680 https://clinicaltrials.gov/ct2/show/NCT01655680?term=NCT01655680. ©Earle E Bain, Laura Shafner, David P Walling, Ahmed A Othman, Christy Chuang-Stein, John Hinkle, Adam Hanina. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 21.02.2017.

  16. Use of a Novel Artificial Intelligence Platform on Mobile Devices to Assess Dosing Compliance in a Phase 2 Clinical Trial in Subjects With Schizophrenia

    2017-01-01

    Background Accurately monitoring and collecting drug adherence data can allow for better understanding and interpretation of the outcomes of clinical trials. Most clinical trials use a combination of pill counts and self-reported data to measure drug adherence, despite the drawbacks of relying on these types of indirect measures. It is assumed that doses are taken, but the exact timing of these events is often incomplete and imprecise. Objective The objective of this pilot study was to evaluate the use of a novel artificial intelligence (AI) platform (AiCure) on mobile devices for measuring medication adherence, compared with modified directly observed therapy (mDOT) in a substudy of a Phase 2 trial of the α7 nicotinic receptor agonist (ABT-126) in subjects with schizophrenia. Methods AI platform generated adherence measures were compared with adherence inferred from drug concentration measurements. Results The mean cumulative pharmacokinetic adherence over 24 weeks was 89.7% (standard deviation [SD] 24.92) for subjects receiving ABT-126 who were monitored using the AI platform, compared with 71.9% (SD 39.81) for subjects receiving ABT-126 who were monitored by mDOT. The difference was 17.9% (95% CI -2 to 37.7; P=.08). Conclusions Using drug levels, this substudy demonstrates the potential of AI platforms to increase adherence, rapidly detect nonadherence, and predict future nonadherence. Subjects monitored using the AI platform demonstrated a percentage change in adherence of 25% over the mDOT group. Subjects were able to use the technology successfully for up to 6 months in an ambulatory setting with early termination rates that are comparable to subjects outside of the substudy. Trial Registration ClinicalTrials.gov NCT01655680 https://clinicaltrials.gov/ct2/show/NCT01655680?term=NCT01655680 PMID:28223265

  17. Transcranial direct current stimulation (tDCS) of frontal cortex decreases performance on the WAIS-IV intelligence test.

    Sellers, Kristin K; Mellin, Juliann M; Lustenberger, Caroline M; Boyle, Michael R; Lee, Won Hee; Peterchev, Angel V; Fröhlich, Flavio

    2015-09-01

    Transcranial direct current stimulation (tDCS) modulates excitability of motor cortex. However, there is conflicting evidence about the efficacy of this non-invasive brain stimulation modality to modulate performance on cognitive tasks. Previous work has tested the effect of tDCS on specific facets of cognition and executive processing. However, no randomized, double-blind, sham-controlled study has looked at the effects of tDCS on a comprehensive battery of cognitive processes. The objective of this study was to test if tDCS had an effect on performance on a comprehensive assay of cognitive processes, a standardized intelligence quotient (IQ) test. The study consisted of two substudies and followed a double-blind, between-subjects, sham-controlled design. In total, 41 healthy adult participants were included in the final analysis. These participants completed the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) as a baseline measure. At least one week later, participants in substudy 1 received either bilateral tDCS (anodes over both F4 and F3, cathode over Cz, 2 mA at each anode for 20 min) or active sham tDCS (2 mA for 40 s), and participants in substudy 2 received either right or left tDCS (anode over either F4 or F3, cathode over Cz, 2 mA for 20 min). In both studies, the WAIS-IV was immediately administered following stimulation to assess for performance differences induced by bilateral and unilateral tDCS. Compared to sham stimulation, right, left, and bilateral tDCS reduced improvement between sessions on Full Scale IQ and the Perceptual Reasoning Index. This demonstration that frontal tDCS selectively degraded improvement on specific metrics of the WAIS-IV raises important questions about the often proposed role of tDCS in cognitive enhancement. Copyright © 2015 Elsevier B.V. All rights reserved.

  18. Patient characteristics and participation in a genetic study: a type 2 diabetes cohort.

    Amiri, Loabat; Cassidy-Bushrow, Andrea E; Dakki, Heather; Li, Jia; Wells, Karen; Oliveria, Susan A; Yood, Marianne Ulcickas; Thomas, Abraham; Lanfear, David E

    2014-01-01

    Recruitment of large, diverse populations into genetic studies remains challenging. Potential strategies to overcome limitations include leveraging electronic health data and minimizing patient burden. We sought to describe the overall participation rate and identify characteristics associated with participation in a genetic substudy of patients with type 2 diabetes mellitus, in which patients were identified via electronic hospital data and asked to participate by providing DNA samples by mail. During a phone interview, participants (n = 455) were asked to take part in a genetic substudy. Subjects verbally consenting were mailed saliva collection kits and written consent forms. We examined demographic and clinical variables associated with verbal consent and DNA kit return using logistic regression. Overall, 90% (n = 410) verbally consented to the genetic substudy during interviews. However, of those consenting, only 70% returned the DNA kit (n = 287). Among those consenting, after covariate adjustment, male sex (odds ratio [OR], 1.70; 95% confidence interval [CI], 1.09-2.65), African American race (OR, 0.61; 95% CI, 0.39-0.95), hemoglobin A1c (HbA1c) (OR, 0.87; 95% CI, 0.75-1.00), and physical activity (OR, 0.58; 95% CI, 0.37-0.91) were significantly associated with DNA kit return. To our knowledge, we are the first to demonstrate an inverse association between HbA1c and participation in genetic research, potentially indicating a compliance-related trait needing further exploration. The DNA kit return rate being notably lower than the verbal consent rate suggests that the greater convenience of a telephone/mail-in process did not drastically enhance full participation. Direct comparison to in-person donation may be warranted.

  19. Regulatory approvals in a large multinational clinical trial: the ESPRIT experience.

    McNay, Laura A; Tavel, Jorge A; Oseekey, Karen; McDermott, Cathy M; Mollerup, David; Bebchuk, Judith D

    2002-02-01

    While accepted as serving an important function to safeguard human subjects, the process of obtaining regulatory approvals to conduct clinical trials is generally regarded as cumbersome and time-consuming. For large multinational trials, U.S. federally sponsored human subject research abroad involves specific U.S. regulatory requirements, in addition to those of the host country, that act as further hurdles. These requirements may include obtaining an Assurance of Protection for Human Subjects from the Office of Human Research Protection of the U.S. Department of Health and Human Services, maintaining specific Ethics Committee/Institutional Review Board (EC/IRB) composition, and incorporating mandated elements in informed consents, all of which may differ from local policies and guidelines. Specific examples of issues that led to delays in regulatory approvals for sites participating in the multinational clinical trial entitled Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT) are presented here. While the goal of these requirements is to protect the rights and welfare of human subjects, they may create substantial delays and engender resentment over the notion of lack of respect for individual country sovereignty. Substudies within ESPRIT have been undertaken to obtain feedback from EC/IRB chairpersons, site personnel responsible for processing the required assurances, ESPRIT investigators, and study participants regarding aspects of current U.S. regulatory requirements related to human subject protection and ethical issues in multinational research. The purpose of these substudies is to compare the attitudes and experiences across countries regarding important ethical issues associated with conducting ESPRIT. One objective of the substudies is to gather additional insight to the impact of U.S. regulatory processes. Another is to help to inform the debate about how to best maximize the rights and welfare of clinical trial

  20. Palbociclib has no clinically relevant effect on the QTc interval in patients with advanced breast cancer.

    Durairaj, Chandrasekar; Ruiz-Garcia, Ana; Gauthier, Eric R; Huang, Xin; Lu, Dongrui R; Hoffman, Justin T; Finn, Richard S; Joy, Anil A; Ettl, Johannes; Rugo, Hope S; Zheng, Jenny; Wilner, Keith D; Wang, Diane D

    2018-03-01

    The aim of this study was to assess the potential effects of palbociclib in combination with letrozole on QTc. PALOMA-2, a phase 3, randomized, double-blind, placebo-controlled trial, compared palbociclib plus letrozole with placebo plus letrozole in postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. The study included a QTc evaluation substudy carried out as a definitive QT interval prolongation assessment for palbociclib. Time-matched triplicate ECGs were performed at 0, 2, 4, 6, and 8 h at baseline (Day 0) and on Cycle 1 Day 14. Additional ECGs were collected from all patients for safety monitoring. The QT interval was corrected for heart rate using Fridericia's correction (QTcF), Bazett's correction (QTcB), and a study-specific correction factor (QTcS). In total, 666 patients were randomized 2 : 1 to palbociclib plus letrozole or placebo plus letrozole. Of these, 125 patients were enrolled in the QTc evaluation substudy. No patients in the palbociclib plus letrozole arm of the substudy (N=77) had a maximum postbaseline QTcS or QTcF value of ≥ 480 ms, or a maximum increase from clock time-matched baseline for QTcS or QTcF values of ≥ 60 ms. The upper bounds of the one-sided 95% confidence interval for the mean change from time-matched baseline for QTcS, QTcF, and QTcB at all time points and at steady-state Cmax following repeated administration of 125 mg palbociclib were less than 10 ms. Palbociclib, when administered with letrozole at the recommended therapeutic dosing regimen, did not prolong the QT interval to a clinically relevant extent.

  1. Design of CIAO, a research program to support the development of an integrated approach to prevent overweight and obesity in the Netherlands.

    van Koperen, Marije Tm; van der Kleij, Rianne Mjj; Renders, Carry Cm; Crone, Matty Mr; Hendriks, Anna-Marie Am; Jansen, Maria M; van de Gaar, Vivian Vm; Raat, Hein Jh; Ruiter, Emilie Elm; Molleman, Gerard Grm; Schuit, Jantine Aj; Seidell, Jacob Jc

    2014-01-01

    The aim of this paper is to describe the research aims, concepts and methods of the research Consortium Integrated Approach of Overweight (CIAO). CIAO is a concerted action of five Academic Collaborative Centres, local collaborations between academic institutions, regional public health services, local authorities and other relevant sectors in the Netherlands. Prior research revealed lacunas in knowledge of and skills related to five elements of the integrated approach of overweight prevention in children (based upon the French EPODE approach), namely political support, parental education, implementation, social marketing and evaluation. CIAO aims to gain theoretical and practical insight of these elements through five sub-studies and to develop, based on these data, a framework for monitoring and evaluation. For this research program, mixed methods are used in all the five sub-studies. First, problem specification through literature research and consultation of stakeholders, experts, health promotion specialists, parents and policy makers will be carried out. Based on this information, models, theoretical frameworks and practical instruments will be developed, tested and evaluated in the communities that implement the integrated approach to prevent overweight in children. Knowledge obtained from these studies and insights from experts and stakeholders will be combined to create an evaluation framework to evaluate the integrated approach at central, local and individual levels that will be applicable to daily practice. This innovative research program stimulates sub-studies to collaborate with local stakeholders and to share and integrate their knowledge, methodology and results. Therefore, the output of this program (both knowledge and practical tools) will be matched and form building blocks of a blueprint for a local evidence- and practice-based integrated approach towards prevention of overweight in children. The output will then support various communities to

  2. What Do Australian Library and Information Professionals Experience as Evidence?

    Ann Gillespie

    2017-03-01

    Full Text Available Objective – This article presents the findings of a project which established an empirical basis for evidence based library and information practice (EBLIP. More specifically, the paper explores what library and information professionals experienced as evidence in the context of their professional practice. Methods – The project consisted of two sub-studies. The public library sub-study was conducted using ethnography. Over a 5-month period, a member of the research team travelled to a regional public library on 15 occasions, staying between 3 and 4 days on each visit. The researcher observed, interacted, and became involved in the day-to-day activities of this library. These activities were recorded in a journal and added to the researcher’s insights and thoughts. Additionally, 13 face-to-face interviews with staff in positions ranging from the operational to the executive were conducted. The academic sub-study was conducted using Constructivist Grounded Theory. Semi-structured interviews were conducted either in person or via Skype, with 13 librarians from Australian universities. Interviewees were in a diverse array of roles, from liaison librarian to manager and library director. Results – The project found that the Australian academic librarians and the public librarians who participated in the project experienced six elements as evidence: observation, feedback, professional colleagues, research literature, statistics, and intuition. Each of these will be described and highlighted with examples from each of the two studies. Conclusions – The findings of this study revealed many similarities in the way that library professionals from both studies experienced evidence. Evidence was not hierarchical, with evidence from many sources being valued equally. In contextualizing evidence and applying to the local environment, library professionals were able to draw upon more than one source of evidence and apply their professional knowledge

  3. Geothermal pilot study final report: creating an international geothermal energy community

    Bresee, J.C.; Yen, W.W.S.; Metzler, J.E. (eds.)

    1978-06-01

    The Geothermal Pilot Study under the auspices of the Committee on the Challenges of Modern Society (CCMS) was established in 1973 to apply an action-oriented approach to international geothermal research and development, taking advantage of the established channels of governmental communication provided by the North Atlantic Treaty Organization (NATO). The Pilot Study was composed of five substudies. They included: computer-based information systems; direct application of geothermal energy; reservoir assessment; small geothermal power plants; and hot dry rock concepts. The most significant overall result of the CCMS Geothermal Pilot Study, which is now complete, is the establishment of an identifiable community of geothermal experts in a dozen or more countries active in development programs. Specific accomplishments include the creation of an international computer file of technical information on geothermal wells and fields, the development of studies and reports on direct applications, geothermal fluid injection and small power plants, and the operation of the visiting scientist program. In the United States, the computer file has aready proven useful in the development of reservoir models and of chemical geothermometers. The state-of-the-art report on direct uses of geothermal energy is proving to be a valuable resource document for laypersons and experts in an area of increasing interest to many countries. Geothermal fluid injection studies in El Salvador, New Zealand, and the United States have been assisted by the Reservoir Assessment Substudy and have led to long-range reservoir engineering studies in Mexico. At least seven small geothermal power plants are in use or have been planned for construction around the world since the Small Power Plant Substudy was instituted--at least partial credit for this increased application can be assigned to the CCMS Geothermal Pilot Study. (JGB)

  4. Chronobiology, sleep-related risk factors and light therapy in perinatal depression: the "Life-ON" project.

    Baiardi, Simone; Cirignotta, Fabio; Cicolin, Alessandro; Garbazza, Corrado; D'Agostino, Armando; Gambini, Orsola; Giordano, Alessandra; Canevini, Mariapaola; Zambrelli, Elena; Marconi, Anna Maria; Mondini, Susanna; Borgwardt, Stefan; Cajochen, Christian; Rizzo, Nicola; Manconi, Mauro

    2016-11-04

    Perinatal depression (PND) has an overall estimated prevalence of roughly 12 %. Untreated PND has significant negative consequences not only on the health of the mothers, but also on the physical, emotional and cognitive development of their children. No certain risk factors are known to predict PND and no completely safe drug treatments are available during pregnancy and breastfeeding. Sleep and depression are strongly related to each other because of a solid reciprocal causal relationship. Bright light therapy (BLT) is a well-tested and safe treatment, effective in both depression and circadian/sleep disorders. In a 3-year longitudinal, observational, multicentre study, about 500 women will be recruited and followed-up from early pregnancy (10-15 gestational week) until 12 months after delivery. The primary aim of the present study is to systematically explore and characterize risk factors for PND by prospective sleep assessment (using wrist actigraphy, polysomnography and various sleep questionnaires) and bloodbased analysis of potential markers during the perinatal period (Life-ON study). Secondary aims are to explore the relationship between specific genetic polymorphisms and PND (substudy Life-ON1), to investigate the effectiveness of BLT in treating PND (substudy Life-ON2) and to test whether a short term trial of BLT during pregnancy can prevent PND (substudy Life-ON3). The characterization of specific predictive and risk factors for PND may substantially contribute to improve preventive medical and social strategies for the affected women. The study results are expected to promote a better understanding of the relationship between sleep disorders and the development of PND and to confirm, in a large sample of women, the safety and efficacy of BLT both in prevention and treatment of PND. ClinicalTrials.gov NCT02664467 . Registered 13 January 2016.

  5. Transcranial Direct Current Stimulation of Frontal Cortex Decreases Performance on the WAIS-IV Intelligence Test

    Sellers, Kristin K.; Mellin, Juliann M.; Lustenberger, Caroline M.; Boyle, Michael R.; Lee, Won Hee; Peterchev, Angel V.; Frohlich, Flavio

    2015-01-01

    Transcranial direct current stimulation (tDCS) modulates excitability of motor cortex. However, there is conflicting evidence about the efficacy of this non-invasive brain stimulation modality to modulate performance on cognitive tasks. Previous work has tested the effect of tDCS on specific facets of cognition and executive processing. However, no randomized, double-blind, sham-controlled study has looked at the effects of tDCS on a comprehensive battery of cognitive processes. The objective of this study was to test if tDCS had an effect on performance on a comprehensive assay of cognitive processes, a standardized intelligence quotient (IQ) test. The study consisted of two substudies and followed a double-blind, between-subjects, sham-controlled design. In total, 41 healthy adult participants completed the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) as a baseline measure. At least one week later, participants in substudy 1 received either bilateral tDCS (anodes over both F4 and F3, cathode over Cz, 2mA at each anode for 20 minutes) or active sham tDCS (2mA for 40 seconds), and participants in substudy 2 received either right or left tDCS (anode over either F4 or F3, cathode over Cz, 2mA for 20 minutes). In both studies, the WAIS-IV was immediately administered following stimulation to assess for performance differences induced by bilateral and unilateral tDCS. Compared to sham stimulation, right, left, and bilateral tDCS reduced improvement between sessions on Full Scale IQ and the Perceptual Reasoning Index. This demonstration that frontal tDCS selectively degraded improvement on specific metrics of the WAIS-IV raises important questions about the often proposed role of tDCS in cognitive enhancement. PMID:25934490

  6. Complement or Contamination: A Study of the Validity of Multiple-Choice Items when Assessing Reasoning Skills in Physics

    Anders Jönsson; David Rosenlund; Fredrik Alvén

    2017-01-01

    The purpose of this study is to investigate the validity of using multiple-choice (MC) items as a complement to constructed-response (CR) items when making decisions about student performance on reasoning tasks. CR items from a national test in physics have been reformulated into MC items and students’ reasoning skills have been analyzed in two substudies. In the first study, 12 students answered the MC items and were asked to explain their answers orally. In the second study, 102 students fr...

  7. INTERVENTION STRATEGIES USED TO ADDRESS ALCOHOL ABUSE IN THE NORTH WEST PROVINCE, SOUTH AFRICA

    Setlalentoa, Marilyn

    2015-09-01

    Full Text Available One of the purposes of the Alcohol Sub-Study of the Prospective Urban and Rural Epidemiological (PURE study was to identify the socio-economic effects of binge drinking from the perspective of community support networks and assess their intervention efforts to address the alcohol abuse problem in the selected areas of study. Emphasis was placed on implementation of plans and legislation; however, eradication of the problem seems to be insignificant for various reasons. This article reports on these identified challenges and proposes appropriate intervention strategies that take cognisance of the nature of the communities for which intervention efforts are intended

  8. Äldre personers sista tid i livet. Livskvalitet, vård, omsorg och närståendes situation.

    Andersson, Magdalena

    2007-01-01

    The aim of this thesis was to investigate old people's care and quality of life during the last period of life, but also to investigate their own and next-of-kin's experience of this phase. The thesis is based on four studies using separate samples. The sample (n=1198) in study I was drawn from the care and services part of the sub-study ?Good Aging in Skåne? (GAS). The criteria for inclusion in study I were: being 75 years and older having died during the years 2001?2004 and having r...

  9. Tromsø eye study

    Bertelsen, Geir; Peto, Tunde; Lindekleiv, Haakon

    2013-01-01

    Purpose:  To determine the prevalence of visual impairment, retinopathy and macular oedema, and assess risk factors for retinopathy in persons with diabetes. Methods:  The present study included 514 participants with diabetes aged 46-87 years from the Tromsø Eye Study, a sub-study of the population......-based Tromsø Study in Norway. Visual acuity was measured using an auto-refractor. Retinal images from both eyes were graded for retinopathy and macular oedema. We collected data on risk factor exposure from self-report questionnaires, clinical examinations, laboratory measurements and case note reviews...

  10. Reproducibility of ultrasonography for assessing abdominal fat distribution in a population at high risk of diabetes

    Philipsen, A; Carstensen, Bendix; Sandbæk, Annelli

    2013-01-01

    the reproducibility of this method have been published.Objective:The aim of this study was to investigate the reproducibility of ultrasonography in the assessment of abdominal fat distribution in a population at high risk of type 2 diabetes.Design and Methods:Ultrasonography was used to estimate visceral......- and interobserver variation, and Bland-Altman plots were drawn for all three substudies.Results:Coefficients of variation for intra- and interobserver variation were in the range 3.4-6.1%, except for interobserver variation for subcutaneous fat (9.5%). Short-term variation over a median of 35 days had a coefficient...

  11. Urinary Neutrophil Gelatinase-Associated Lipocalin and Progression of Diabetic Nephropathy in Type 1 Diabetic Patients in a Four-Year Follow-Up Study

    Nielsen, Stine Elkjaer; Hansen, Henrik Post; Jensen, Berit Ruud

    2010-01-01

    Background: Neutrophil gelatinase-associated lipocalin (NGAL), a marker of renal tubular damage, predicts progression in non-diabetic chronic kidney. We evaluated urinary (u)-NGAL as a predictor of progression in diabetic nephropathy in type 1 diabetic (T1D) patients. Methods: As a substudy of a 4......-year randomized, intervention study evaluating low-protein diet in T1D patients with diabetic nephropathy, 78 patients were studied with yearly measurements of u-NGAL (ELISA, BioPorto). Outcome: Decline in glomerular filtration rate (GFR) ((51)Cr-EDTA), and end-stage renal disease (ESRD) or death...

  12. Gender specific effect of major dietary patterns on the metabolic syndrome risk in Korean pre-pubertal children

    Park, Soo Jin; Lee, Seung Min; Kim, Seon Mee; Lee, Myoungsook

    2013-01-01

    There is a lack of data on metabolic risk factors during pre-puberty, which is important for identifying the subgroups of youth, at whom early interventions should be targeted. In this study, we evaluated the prevalence of metabolic risk factors and its subsequent relations with dietary patterns in Korean pre-pubertal children through a cross-sectional sample (n = 1,008; boys = 513) of pre-pubertal children (aged 8-9 years) from a sub-study of the Korea Metabolic Syndrome Research Initiatives...

  13. Fatherhood in adolescence: prevalence and associated factors in a community sample of youngsters.

    Oliveira, Milene Maria Saalfeld de; Branco, Jerônimo Costa; Souza, Luciano Dias de Mattos; Silva, Ricardo Azevedo da; Lara, Diogo Rizzato; Mota, Denise Marques; Jansen, Karen

    2015-11-01

    This article aims to assess the prevalence of fatherhood in adolescence (FA) and associated factors in a community sample of 14 to 35 year-old men. Cross-sectional population-based study realized in the urban area of the city of Pelotas-RS, Brazil. The sample was selected by clusters, according to the city census. This sub-study only comprised sexually active men. Data were collected using a self-administered questionnaire in the participants' homes. The sample was composed for 934 men. The prevalence of fatherhood in adolescence was 8% (n = 75). We verified higher prevalence of FA among those that reported paternal absence (p fatherhood in adolescence.

  14. Energy use of decayed wood; Lahopuun maeaerae, sisaeltoe ja hankintakustannukset

    Maekelae, M; Lipponen, K [Metsaeteho Oy, Helsinki (Finland)

    1997-12-01

    A study of the quality, amounts and delivery costs of decayed wood available for possible energy use will be carried out in co-operation by Metsaeteho and Forest Research Institute. The work will consist of the following sub-studies: Quality of decayed wood available for possible energy use, quantities of decayed wood available for possible energy use by municipalities in Western and Southern Finland, harvesting, transport and chipping costs of decayed wood in different delivery alternatives and as a practical example, quantities of decayed wood available for possible energy use in two potential consumption municipalities. (orig.)

  15. Higher protein intake is not associated with decreased kidney function in pre-diabetic older adults following a one-year intervention

    Møller, Grith; Andersen, Jens Rikardt; Ritz, Christian

    2018-01-01

    Concerns about detrimental renal effects of a high-protein intake have been raised due to an induced glomerular hyperfiltration, since this may accelerate the progression of kidney disease. The aim of this sub-study was to assess the effect of a higher intake of protein on kidney function in pre-diabetic...... intake and creatinine clearance, eGFR, ACR, or serum creatinine. We found no indication of impaired kidney function after one year with a higher protein intake in pre-diabetic older adults....

  16. Development and validation of a new global well-being outcomes rating scale for integrative medicine research

    Bell Iris R

    2004-01-01

    Full Text Available Abstract Background Researchers are finding limitations of currently available disease-focused questionnaire tools for outcome studies in complementary and alternative medicine/integrative medicine (CAM/IM. Methods Three substudies investigated the new one-item visual analogue Arizona Integrative Outcomes Scale (AIOS, which assesses self-rated global sense of spiritual, social, mental, emotional, and physical well-being over the past 24 hours and the past month. The first study tested the scale's ability to discriminate unhealthy individuals (n = 50 from healthy individuals (n = 50 in a rehabilitation outpatient clinic sample. The second study examined the concurrent validity of the AIOS by comparing ratings of global well-being to degree of psychological distress as measured by the Brief Symptom Inventory (BSI in undergraduate college students (N = 458. The third study evaluated the relationships between the AIOS and positively- and negatively-valenced tools (Positive and Negative Affect Scale and the Positive States of Mind Scale in a different sample of undergraduate students (N = 62. Results Substudy (i Rehabilitation patients scored significantly lower than the healthy controls on both forms of the AIOS and a current global health rating. The AIOS 24-hours correlated moderately and significantly with global health (patients r = 0.50; controls r = 0.45. AIOS 1-month correlations with global health were stronger within the controls (patients r = 0.36; controls r = 0.50. Controls (r = 0.64 had a higher correlation between the AIOS 24-hour and 1-month forms than did the patients (r = 0.33, which is consistent with the presumptive improvement in the patients' condition over the previous 30 days in rehabilitation. Substudy (ii In undergraduate students, AIOS scores were inversely related to distress ratings, as measured by the global severity index on the BSI (rAIOS24h = -0.42, rAIOS1month = -0.40. Substudy (iii AIOS scores were significantly

  17. Data and results

    1980-01-01

    In order to assess the radioecological consequences to the environment caused by the discharge of radioactive material at normal operation, taking into account the exposure from other sources of radiation, existing model concepts for calculating the radiation exposure and the relevant assumptions and parameters have to be specialized for the Biblis site. All relevant problems and decisions are discussed in an open manner and the minutes are made available to the public. The substudies investigating the aspects of the atmospheric and the water pathway often have been treated by means of competing models. (RW) [de

  18. Active placebo control groups of pharmacological interventions were rarely used but merited serious consideration

    Jensen, Jakob Solgaard; Bielefeldt, Andreas Ørsted; Hróbjartsson, Asbjørn

    2017-01-01

    groups based on a random sample of 200 PubMed indexed placebo-controlled randomized drug trials published in October 2013. In a systematic review, we identified and characterized trials with active placebo control groups irrespective of publication time. In a third substudy, we reviewed publications...... with substantial methodological comments on active placebo groups (searches in PubMed, The Cochrane Library, Google Scholar, and HighWirePress). Results The prevalence of trials with active placebo groups published in 2013 was 1 out of 200 (95% confidence interval: 0–2), 0.5% (0–1%). We identified...

  19. Perceptions of Community HIV/ STI Risk Among U.S Women Living in Areas with High Poverty and HIV Prevalence Rates

    Blackstock, Oni J.; Frew, Paula; Bota, Dorothy; Vo-Green, Linda; Parker, Kim; Franks, Julie; Hodder, Sally L.; Justman, Jessica; Golin, Carol E.; Haley, Danielle F.; Kuo, Irene; Adimora, Adaora A.; Rompalo, Anne; Soto-Torres, Lydia; Wang, Jing

    2015-01-01

    Although studies have consistently demonstrated that women at high risk for HIV and non-HIV sexually transmitted infections (STIs) tend to underestimate their individual risk, little is known about how women at risk perceive their community’s HIV/STI risk. We explored perceptions of community HIV/ STI risk among U.S. women living in areas with high poverty and HIV prevalence rates as part of a qualitative substudy of the Women’s HIV SeroIncidence Study. Semi-structured focus groups were condu...

  20. A school meal study: comparing platewaste and likings of packed lunch and school lunch based on the New Nordic Diet

    Thorsen, Anne Vibeke; Lassen, Anne Dahl; Christensen, Lene M.

    2013-01-01

    Background and objectives: The majority of Danish children do not eat in accordance with the national dietary guidelines. The OPUS School Meal Study is a school-based intervention study testing the health effects of the New Nordic Diet (NND). The aim of this sub-study was to compare edible plate.......0; 119.0). Lunches rated as ‘really bad’ or ‘bad’ in the self-reported likings had more waste than lunches rated ‘really good’ (P

  1. The PULSAR Specialist Care protocol: a stepped-wedge cluster randomized control trial of a training intervention for community mental health teams in recovery-oriented practice.

    Shawyer, Frances; Enticott, Joanne C; Brophy, Lisa; Bruxner, Annie; Fossey, Ellie; Inder, Brett; Julian, John; Kakuma, Ritsuko; Weller, Penelope; Wilson-Evered, Elisabeth; Edan, Vrinda; Slade, Mike; Meadows, Graham N

    2017-05-08

    Recovery features strongly in Australian mental health policy; however, evidence is limited for the efficacy of recovery-oriented practice at the service level. This paper describes the Principles Unite Local Services Assisting Recovery (PULSAR) Specialist Care trial protocol for a recovery-oriented practice training intervention delivered to specialist mental health services staff. The primary aim is to evaluate whether adult consumers accessing services where staff have received the intervention report superior recovery outcomes compared to adult consumers accessing services where staff have not yet received the intervention. A qualitative sub-study aims to examine staff and consumer views on implementing recovery-oriented practice. A process evaluation sub-study aims to articulate important explanatory variables affecting the interventions rollout and outcomes. The mixed methods design incorporates a two-step stepped-wedge cluster randomized controlled trial (cRCT) examining cross-sectional data from three phases, and nested qualitative and process evaluation sub-studies. Participating specialist mental health care services in Melbourne, Victoria are divided into 14 clusters with half randomly allocated to receive the staff training in year one and half in year two. Research participants are consumers aged 18-75 years who attended the cluster within a previous three-month period either at baseline, 12 (step 1) or 24 months (step 2). In the two nested sub-studies, participation extends to cluster staff. The primary outcome is the Questionnaire about the Process of Recovery collected from 756 consumers (252 each at baseline, step 1, step 2). Secondary and other outcomes measuring well-being, service satisfaction and health economic impact are collected from a subset of 252 consumers (63 at baseline; 126 at step 1; 63 at step 2) via interviews. Interview-based longitudinal data are also collected 12 months apart from 88 consumers with a psychotic disorder

  2. Geographical and temporal variations in clozapine prescription for schizophrenia

    Nielsen, Jimmi; Røge, Rasmus; Schjerning, Ole

    2012-01-01

    Despite its unsurpassed efficacy in treatment-resistant schizophrenia, clozapine remains underutilized. Trends in the prescription of clozapine in patients with ICD-10 F20.x schizophrenia were assessed using data from Danish national registers. Three substudies were carried out: (i) an assessment...... of differences in national prescription patterns between 1996 and 2007 using a cross-sectional design; (ii) a comparison of time from first schizophrenia diagnosis to first prescription of clozapine in a five-year cohort study, using the Cox regression model, of two patient groups who were first diagnosed...

  3. The Tiotropium Safety and Performance in Respimat® (TIOSPIR®) Trial

    Anzueto, Antonio; Wise, Robert; Calverley, Peter

    2015-01-01

    ). The rate of FEV1 decline in GOLD I + II patients was greater than in GOLD III + IV patients (46 vs. 23 mL/year); as well as in current versus ex-smokers, in patients receiving combination therapies at baseline versus not, and in those experiencing an exacerbation during the study versus not. CONCLUSIONS......BACKGROUND: Tiotropium Safety and Performance in Respimat® (TIOSPIR®) compared the safety and efficacy of tiotropium Respimat® and tiotropium HandiHaler® in patients with chronic obstructive pulmonary disease (COPD). A prespecified spirometry substudy compared the lung function efficacy between...

  4. Factors associated with low-lying intrauterine devices: a cross-sectional ultrasound study in a cohort of African-American women.

    Moshesh, Malana; Saldana, Tina; Deans, Elizabeth; Cooper, Tracy; Baird, Donna

    2018-03-14

    The object of this study is to examine factors and symptoms associated with low-lying IUDs as defined by ultrasound. This is a cross-sectional sub-study of participants in the Study of Environment, Life-style, and Fibroids (SELF). SELF participants had screening ultrasounds for fibroids at study enrollment; those with an IUD in place are included in this sub-study. Low-lying IUDs were identified and localized. Logistic regression was used to identify factors and symptoms associated with low-lying IUDs. Among 168 women with IUDs at ultrasound, 28 (17%) had a low-lying IUD. Having a low-lying IUD was associated with low education level (≤high school: aOR 3.1 95% CI 1.14-8.55) and with increased BMI (p=.002). Women with a low-lying IUD were more likely to report a "big problem" with dysmenorrhea (the highest option of the Likert scale) as compared to women with a normally-positioned IUD (OR 3.2 95% CI 1.07-9.54). Our study found that women with a low-lying IUD are more likely to be of lower education and higher BMI, and to report more dysmenorrhea. Women who are obese may benefit from additional counseling and closer follow-up after IUD placement. Future research is warranted to investigate IUD placement and possible IUD migration among women who are obese. Copyright © 2018 Elsevier Inc. All rights reserved.

  5. An overview of four studies of a continuous oral contraceptive (levonorgestrel 90 mcg/ethinyl estradiol 20 mcg) on premenstrual dysphoric disorder and premenstrual syndrome.

    Freeman, Ellen W; Halbreich, Uriel; Grubb, Gary S; Rapkin, Andrea J; Skouby, Sven O; Smith, Lynne; Mirkin, Sebastian; Constantine, Ginger D

    2012-05-01

    This article presents an overview of four studies that evaluated a continuous oral contraceptive (OC) containing levonorgestrel (90 mcg) and ethinyl estradiol (20 mcg; LNG/EE) for managing premenstrual dysphoric disorder (PMDD) and premenstrual syndrome (PMS). Three randomized, double-blind, placebo-controlled trials and one open-label, single-treatment substudy examined mean changes from baseline in the Daily Record of Severity of Problems (DRSP) or Penn Daily Symptom Rating (DSR). Improvements from baseline in mean DRSP and DSR scores were observed, but results were not consistent among the studies. Mean percent improvement of premenstrual symptoms ranged from 30% to 59% in controlled trials and 56% to 81% in an open-label substudy. A large placebo effect was also observed in the placebo-controlled studies. Continuous LNG/EE yielded a favorable safety profile. These data, although not consistent, indicate that continuous LNG/EE may reduce the symptoms of PMDD and PMS, providing an option for women who are appropriate candidates for a continuous OC as a contraceptive, the approved indication for this medication. Copyright © 2012 Elsevier Inc. All rights reserved.

  6. Neuropsychological outcome after percutaneous coronary intervention or coronary artery bypass grafting: results from the Stent or Surgery (SoS) Trial.

    Währborg, Peter; Booth, Jean E; Clayton, Tim; Nugara, Fiona; Pepper, John; Weintraub, William S; Sigwart, Ulrich; Stables, Rod H

    2004-11-30

    Coronary artery bypass surgery (CABG) has been associated with a range of neurological and neuropsychological complications from stroke to cognitive problems such as memory and problem solving disturbance. However, little is known about the impact of percutaneous coronary intervention (PCI) on neuropsychological outcome. In the Stent or Surgery Trial (SoS), 988 patients were randomized in equal proportions between PCI supported by stent implantation and CABG. As a substudy of this trial, we undertook an evaluation of neurological and neuropsychological outcomes after intervention. A clinical examination and neuropsychological assessment consisting of 5 tests (Digit Span Forwards and Backwards, Visual Reproduction, Bourdon, and Block Design) were performed at baseline and 6 and 12 months after the procedure. A total of 145 patients were included in the substudy analysis: 77 in the PCI group and 68 in the CABG group. One patient in the PCI arm had a stroke. There was no significant difference between treatment groups at 6 and 12 months for any of the 5 tests. The mean change from baseline was also similar in both groups. We were not able to demonstrate an important and significant difference in neuropsychological outcome in patients treated with different revascularization strategies. This important finding needs to be examined in further research.

  7. Men at risk; a qualitative study on HIV risk, gender identity and violence among men who have sex with men who report high risk behavior in Kampala, Uganda.

    King, Rachel; Barker, Joseph; Nakayiwa, Sylvia; Katuntu, David; Lubwama, George; Bagenda, Danstan; Lane, Tim; Opio, Alex; Hladik, Wolfgang

    2013-01-01

    In Uganda, men who have sex with men (MSM) are at high risk for HIV. Between May 2008 and February 2009 in Kampala, Uganda, we used respondent driven sampling (RDS) to recruit 295 MSM≥18 years who reported having had sex with another man in the preceding three months. The parent study conducted HIV and STI testing and collected demographic and HIV-related behavioral data through audio computer-assisted self-administered interviews. We conducted a nested qualitative sub-study with 16 men purposively sampled from among the survey participants based on responses to behavioral variables indicating higher risk for HIV infection. Sub-study participants were interviewed face-to-face. Domains of inquiry included sexual orientation, gender identity, condom use, stigma, discrimination, violence and health seeking behavior. Emergent themes included a description of sexual orientation/gender identity categories. All groups of men described conflicting feelings related to their sexual orientation and contextual issues that do not accept same-sex identities or behaviors and non-normative gender presentation. The emerging domains for facilitating condom use included: lack of trust in partner and fear of HIV infection. We discuss themes in the context of social and policy issues surrounding homosexuality and HIV prevention in Uganda that directly affect men's lives, risk and health-promoting behaviors.

  8. [Current role of metformin in treatment of diabetes mellitus type 2].

    Janssen, J A

    2000-09-30

    Metformin-associated lactic acidosis is not necessarily due to metformin accumulation. It appears that mortality in patients receiving metformin who develop lactic acidosis is mostly linked to underlying disease. It has been suggested that metformin should be the first-line agent for the treatment of obese type 2 diabetic patients since metformin was associated with a significant decrease in macrovascular events and a reduction of all-cause mortality in the United Kingdom Prospective Diabetes Study (UKPDS) in a substudy. However, in this substudy no significant decrease in microvascular complications was observed in obese subjects with intensive metformin therapy. In addition, the use of metformin in combination with sulfonylurea seemed to be associated with excess risk of diabetes-related and all-cause mortality in obese subjects. Due to the discrepant and contradictory nature of the results in the obese patients and a lack of power the UKPDS offered no decision for any drug for initial therapy of type 2 diabetes. The main message of the UKPDS is that lowering of the blood glucose to the normal range is beneficial irrespective of the hypoglycaemic agent used. A rational approach to therapy in a type 2 diabetes patient who fails to sufficiently lower blood sugar with diet and weight loss is to begin therapy with a sulfonylurea or metformin and to add another oral agent if the desired glycaemic control is not achieved.

  9. Etnomatemáticas indígenas y formación docente: una experiencia en Costa Rica a través del modelo MOCEMEI

    María Elena Gavarrete Villaverde

    2015-07-01

    Full Text Available This paper shows the development and results of a research developed with primary teachers working in indigenous environments in Costa Rica. It has a double object of study: the Ethnomathematics of three ethnic groups and the teacher training within a model intercultural based on Ethnomathematics. The theoretical foundations of the study are based on Ethnomathematics, enculturation and learning by micro-projects. Also has some empirical foundations that consist of four sub-studies: an ethnological diagnose made with three ethnic groups in Costa Rica, as well as three diagnoses in which participated 30 professionals that work on issues of education and culture, 69 elementary school teachers working in indigenous contexts, and 11 professionals specialist on pedagogical issues. With the results of the four sub-studies, has been proposed a course of teacher training based on Indigenous Ethnomathematics. The experience of implementation of the course was evaluated through a participatory ethnographic method, and also by the content analysis generated by the micro-project and the portfolio developed and based on Indigenous Ethnomathematics. Its evaluation led to propose a teacher training model based on Indigenous Ethnomathematics. It is proposed a discussion about cultural relevance and about the ways to provide teacher training pertinent to contexts, as well as about the relationship between cultural knowledge and school mathematical knowledge.

  10. Honoring Identity Through Mealtimes in Chinese Canadian Immigrants.

    Lam, Ivy T Y; Keller, Heather H

    2015-11-01

    Mealtimes are opportunities for social interactions and expressions of individual and family identity, and serve as a microcosm of the broader lives of families living with dementia. The Eating Together study and its resulting Life Nourishment Theory (LNT) explicated the importance of mealtimes for honouring individual and family identities in the context of dementia. This sub-study examined a specific ethnocultural group with cultural food-ways and caring expectations, to determine if the concept of honouring identity needed to be modified or extended. Using active interview techniques, two Cantonese speaking researchers completed dyad/triad family and individual interviews with six Chinese Canadian immigrant families, recruited from two service providers in a large, urban, multicultural city. This sub-study provided insight into the challenges and rewards of mealtimes for Chinese immigrant families with dementia in the community and specifically provided further insights into the honouring identity concept. Although LNT and specifically the honouring identity concept was generally confirmed in this group, some culturally-specific themes were also identified. This work serves as a basis for future studies examining the meaning and experience of mealtimes in specific cultural groups living with dementia. Such work would confirm if the LNT can be applied to specific ethnocultural groups as well as the general population living with dementia. © The Author(s) 2012.

  11. Evaluation of 2 new optical biometry devices and comparison with the current gold standard biometer.

    Chen, Yen-An; Hirnschall, Nino; Findl, Oliver

    2011-03-01

    To compare 2 new optical biometry devices with the present gold standard biometer. Vienna Institute for Research in Ocular Surgery, Department of Ophthalmology, Hanusch Hospital, Vienna, Austria. Evaluation of diagnostic test or technology. In patients scheduled for cataract surgery, measurements performed with the current gold standard optical biometer (IOLMaster) were compared with those of 2 new optical biometers, the Lenstar LS 900 (optical low-coherence reflectometry [OLCR] device; substudy 1) and the IOLMaster 500 (partial coherence interferometry [PCI] device; substudy 2). The duration of patient data entry and of the actual measurement process and the time from intraocular lens power calculation to printout were calculated. The mean difference in axial length measurements was 0.01 mm ± 0.05 (SD) between the gold standard device and the new OLCR device and 0.01 ± 0.02 mm between the gold standard device and the new PCI device (P=.12 and P gold standard device (mean difference 209 ± 127 seconds), and measurements with the gold standard device took significantly longer than with the new PCI device (mean difference 82 ± 46 seconds) (both P gold standard device. Measurements with the new OLCR device took twice as long as those with the gold standard device. Copyright © 2011 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

  12. Who are the support persons of haematological cancer survivors and how is their performance perceived?

    Hall, Alix; Lynagh, Marita; Carey, Mariko; Sanson-Fisher, Rob; Mansfield, Elise

    2017-12-01

    To explore: (1) how haematological cancer survivors and their support persons perceive the overall performance of the support person; (2) disagreement between survivor and support person ratings; and (3) characteristics associated with support persons rating their performance poorly. This is a substudy of a larger project of Australian haematological cancer survivors and their support persons. For this substudy, haematological cancer survivors were recruited from 4 Australian population-based cancer registries and asked to pass on a questionnaire package to their support persons. Survivors who passed on a questionnaire package to their support person were asked to answer questions about the support person and how they perceived the support person's performance. Similarly, support persons answered questions on their own performance as a support person. A total of 924 haematological cancer survivors and 821 support persons were eligible for this study. Most survivors rated their support person as performing very well (84%) while less than half (48%) of support persons rated their own performance as very well. There was significant disagreement between survivor and their support person (dyad) ratings of the support person's performance. Support persons with above normal levels of depression (vs those with normal levels) had significantly higher odds of rating their own performance as "not well/somewhat well." Health care providers should consider providing additional education and skills-based interventions to support persons who experience increased symptoms of depression. Copyright © 2017 John Wiley & Sons, Ltd.

  13. Recruiting Dementia Caregivers Into Clinical Trials: Lessons Learnt From the Australian TRANSCENDENT Trial.

    Leach, Matthew J; Ziaian, Tahereh; Francis, Andrew; Agnew, Tamara

    2016-01-01

    The burden on those caring for a person with dementia is substantial. Although quality research assists in addressing the needs of these caregivers, recruiting caregivers into clinical studies is often problematic. This investigation explores the difficulties and successes in recruiting dementia caregivers into community-based clinical research by reporting the findings of a mixed-method substudy of a multicenter randomized controlled trial involving 40 community-dwelling dementia caregivers living in Adelaide, South Australia. Data for the substudy were derived from standardized trial monitoring documentation and structured telephone interviews. From a total of 16 distinct methods used across a 12-month recruitment campaign, the most cost-effective strategy was the distribution of flyers through a single study site. This approach generated the greatest number of enrollments of all methods used, achieving a 67% recruitment yield. The least cost-effective strategy, with a 0% recruitment yield, was the publication of a newspaper advertisement. Themes that emerged from the interviews pointed toward 5 key facilitators and 3 barriers to future trial recruitment. This study has generated new insights into the effective recruitment of dementia caregivers into clinical trials. We anticipate that these lessons learnt will assist in shaping the recruitment strategies of future studies of dementia caregivers.

  14. Sex, PrEP, and Stigma: Experiences with HIV Pre-exposure Prophylaxis Among New York City MSM Participating in the HPTN 067/ADAPT Study.

    Franks, Julie; Hirsch-Moverman, Yael; Loquere, Avelino S; Amico, K Rivet; Grant, Robert M; Dye, Bonnie J; Rivera, Yan; Gamboa, Robert; Mannheimer, Sharon B

    2018-04-01

    The HPTN 067/Alternative Dosing to Augment Pre-Exposure Prophylaxis Pill Taking (ADAPT) study evaluated daily and non-daily dosing schedules for oral pre-exposure prophylaxis (PrEP) to prevent HIV. A qualitative sub-study including focus groups and in-depth interviews was conducted among men who have sex with men participating in New York City to understand their experience with PrEP and study dosing schedules. The 37 sub-study participants were 68% black, 11% white, and 8% Asian; 27% were of Hispanic/Latino ethnicity. Mean age was 34 years. Themes resulting from qualitative analysis include: PrEP is a significant advance for HIV prevention; non-daily dosing of PrEP is congruent with HIV risk; and pervasive stigma connected to HIV and risk behavior is a barrier to PrEP adherence, especially for non-daily dosing schedules. The findings underscore how PrEP intersects with other HIV prevention practices and highlight the need to understand and address multidimensional stigma related to PrEP use.

  15. Men at risk; a qualitative study on HIV risk, gender identity and violence among men who have sex with men who report high risk behavior in Kampala, Uganda.

    Rachel King

    Full Text Available In Uganda, men who have sex with men (MSM are at high risk for HIV. Between May 2008 and February 2009 in Kampala, Uganda, we used respondent driven sampling (RDS to recruit 295 MSM≥18 years who reported having had sex with another man in the preceding three months. The parent study conducted HIV and STI testing and collected demographic and HIV-related behavioral data through audio computer-assisted self-administered interviews. We conducted a nested qualitative sub-study with 16 men purposively sampled from among the survey participants based on responses to behavioral variables indicating higher risk for HIV infection. Sub-study participants were interviewed face-to-face. Domains of inquiry included sexual orientation, gender identity, condom use, stigma, discrimination, violence and health seeking behavior. Emergent themes included a description of sexual orientation/gender identity categories. All groups of men described conflicting feelings related to their sexual orientation and contextual issues that do not accept same-sex identities or behaviors and non-normative gender presentation. The emerging domains for facilitating condom use included: lack of trust in partner and fear of HIV infection. We discuss themes in the context of social and policy issues surrounding homosexuality and HIV prevention in Uganda that directly affect men's lives, risk and health-promoting behaviors.

  16. Subjectivation, togetherness, environment. Potentials of participatory art for Art Education for Sustainable Development (AESD

    Helene Illeris

    2017-06-01

    Full Text Available Through a process-oriented analysis of the participatory art project The Hill this article explores the relevance of participatory art projects for the development of AESD – Art Education for Sustainable Development. Inspired by Felix Guattari’s Three Ecologies (2008 the analysis moves through three sub-studies delving into three different aspects of the project. Each sub-study adopts two overlapping analytical ‘lenses’: The lens of a contemporary art form (performance art, community art, and site-specific art and the lens of a related theoretical concept (subjectivation, togetherness, environment. The aim is to propose art educational ideas and strategies that stimulate students to challenge the current political, economic and environmental situation. Central questions addressed by the article are: How can educators use contemporary artistic strategies to challenge essentialist and opportunistic self-understandings? What is the potential for participatory art forms to explore alternative and more sustainable conceptions of human subjectivity? How can art education work in favour of a sense of interconnectedness between the individual, the social and the environmental dimensions of being? In conclusion, the article proposes art education as a symbolic place for carrying out art-inspired experiments with how to live our lives in more sustainable ways.

  17. Active placebo control groups of pharmacological interventions were rarely used but merited serious consideration: a methodological overview.

    Jensen, Jakob Solgaard; Bielefeldt, Andreas Ørsted; Hróbjartsson, Asbjørn

    2017-07-01

    Active placebos are control interventions that mimic the side effects of the experimental interventions in randomized trials and are sometimes used to reduce the risk of unblinding. We wanted to assess how often randomized clinical drug trials use active placebo control groups; to provide a catalog, and a characterization, of such trials; and to analyze methodological arguments for and against the use of active placebo. An overview consisting of three thematically linked substudies. In an observational substudy, we assessed the prevalence of active placebo groups based on a random sample of 200 PubMed indexed placebo-controlled randomized drug trials published in October 2013. In a systematic review, we identified and characterized trials with active placebo control groups irrespective of publication time. In a third substudy, we reviewed publications with substantial methodological comments on active placebo groups (searches in PubMed, The Cochrane Library, Google Scholar, and HighWirePress). The prevalence of trials with active placebo groups published in 2013 was 1 out of 200 (95% confidence interval: 0-2), 0.5% (0-1%). We identified and characterized 89 randomized trials (published 1961-2014) using active placebos, for example, antihistamines, anticholinergic drugs, and sedatives. Such trials typically involved a crossover design, the experimental intervention had noticeable side effects, and the outcomes were patient-reported. The use of active placebos was clustered in specific research settings and did not appear to reflect consistently the side effect profile of the experimental intervention, for example, selective serotonin reuptake inhibitors were compared with active placebos in pain trials but not in depression trials. We identified and analyzed 25 methods publications with substantial comments. The main argument for active placebo was to reduce risk of unblinding; the main argument against was the risk of unintended therapeutic effect. Pharmacological

  18. Evaluation of Mechanisms to Improve Performance of Mobile Phone Surveys in Low- and Middle-Income Countries: Research Protocol.

    Gibson, Dustin G; Pariyo, George William; Wosu, Adaeze C; Greenleaf, Abigail R; Ali, Joseph; Ahmed, Saifuddin; Labrique, Alain B; Islam, Khaleda; Masanja, Honorati; Rutebemberwa, Elizeus; Hyder, Adnan A

    2017-05-05

    Mobile phone ownership and access have increased rapidly across low- and middle-income countries (LMICs) within the last decade. Concomitantly, LMICs are experiencing demographic and epidemiologic transitions, where non-communicable diseases (NCDs) are increasingly becoming leading causes of morbidity and mortality. Mobile phone surveys could aid data collection for prevention and control of these NCDs but limited evidence of their feasibility exists. The objective of this paper is to describe a series of sub-studies aimed at optimizing the delivery of interactive voice response (IVR) and computer-assisted telephone interviews (CATI) for NCD risk factor data collection in LMICs. These sub-studies are designed to assess the effect of factors such as airtime incentive timing, amount, and structure, survey introduction characteristics, different sampling frames, and survey modality on key survey metrics, such as survey response, completion, and attrition rates. In a series of sub-studies, participants will be randomly assigned to receive different airtime incentive amounts (eg, 10 minutes of airtime versus 20 minutes of airtime), different incentive delivery timings (airtime delivered before survey begins versus delivery upon completion of survey), different survey introductions (informational versus motivational), different narrative voices (male versus female), and different sampling frames (random digit dialing versus mobile network operator-provided numbers) to examine which study arms will yield the highest response and completion rates. Furthermore, response and completion rates and the inter-modal reliability of the IVR and CATI delivery methods will be compared. Research activities are expected to be completed in Bangladesh, Tanzania, and Uganda in 2017. This is one of the first studies to examine the feasibility of using IVR and CATI for systematic collection of NCD risk factor information in LMICs. Our findings will inform the future design and

  19. Impact of left ventricular geometry on prognosis in hypertensive patients with left ventricular hypertrophy (the LIFE study)

    Gerdts, E.; Cramariuc, D.; Simone, G. de

    2008-01-01

    , and myocardial infarction) in 937 hypertensive patients with LV hypertrophy during 4.8 years losartan- or atenolol-based treatment in the Losartan Intervention for Endpoint reduction in hypertension (LIFE) echocardiography substudy. METHODS AND RESULTS: LV geometry was determined from LV mass/body surface area......AIMS: Less is known about the relation between in-treatment left ventricular (LV) geometry and risk of cardiovascular events. We assessed LV geometric patterns on baseline and annual echocardiograms as time-varying predictors of the primary composite endpoint (cardiovascular death, stroke...... including LV geometric patterns as time-varying variables and adjusting for treatment, Framingham risk score, race, and time-varying systolic blood pressure, the patterns independently predicted higher risk of primary composite endpoints [HR 2.99 (1.16-7.71) for concentric remodelling, HR 1.79 (1...

  20. Does a variation in self-reported physical activity reflect variation in objectively measured physical activity, resting heart rate, and physical fitness? Results from the Tromso study

    Emaus, Aina; Degerstrøm, Jorid; Wilsgaard, Tom

    2010-01-01

    AIMS: To study the association between self-reported physical activity (PA) and objectively measured PA, resting heart rate, and physical fitness. METHODS: During 2007-08, 5017 men and 5607 women aged 30-69 years attended the sixth survey of the Tromsø study. Self-reported PA during leisure......-time and work were assessed and resting heart rate was measured. In a sub-study, the activity study, PA (Actigraph LLC) and physical fitness (VO₂(max)) were objectively measured among 313 healthy men and women aged 40-44 years. RESULTS: Self-reported leisure PA was significantly correlated with VO₂(max) (ml...... women than men met the international recommendations of 10,000 step counts/day (27% vs. 22%) and the recommendation of at least 30 minutes/day of moderate-to-vigorous intensities (30% vs. 22 %). CONCLUSIONS: The Tromsø physical activity questionnaire has acceptable validity and provides valid estimates...

  1. An evaluation of two guidance programmes to promote breast-feeding

    M. Steyn

    1989-09-01

    Full Text Available During the past ten years a comprehensive research project has been undertaken to develop a guidance programme in three adjacent communities in the South- Western Cape with the aim o f lowering the high incidence o f coronary heart disease. The purpose o f this substudy was to determine whether the guidance provided in the different communities had any influence on the knowledge o f and attitudes towards the nutrition o f pregnant women, babies and infants as well as breast-feeding practices o f the women who gave birth during the period 1980 to 1986. In the first community guidance was provided by means o f small mass media and interpersonal communication whereas only the small mass media were employed in the second. The third served as the control community. The findings suggest that the combined interpersonal and mass media programme was more successful than the mass media programme alone.

  2. Comparison of Outcomes in Patients With Versus Without Diabetes Mellitus After Revascularization With Everolimus- and Sirolimus-Eluting Stents (from the SORT OUT IV Trial)

    Jensen, Lisette Okkels; Thayssen, Per; Junker, Anders

    2012-01-01

    Diabetes is associated with increased risk of major adverse cardiac events (MACEs) after percutaneous coronary intervention. The purpose of this substudy of the SORT OUT IV trial was to compare clinical outcomes in patients with and without diabetes mellitus treated with everolimus-eluting stents...... (EESs) or sirolimus-eluting stents (SESs). In total 2,774 patients (390 with diabetes, 14.1%) were randomized to stent implantation with EESs (n = 1,390, diabetes in 14.0%) or SESs (n = 1,384, diabetes in 14.2%). Randomization was stratified by presence/absence of diabetes. The primary end point...... was MACEs, a composite of cardiac death, myocardial infarction, definite stent thrombosis, or target vessel revascularization within 18 months. MACEs were higher in diabetic than in nondiabetic patients (13.1% vs 6.4%, hazard ratio [HR] 2.08, 95% confidence interval [CI] 1.51 to 2.86). In diabetic patients...

  3. Move the Neighbourhood: a novel study design of a participatory public open space intervention in a Danish deprived neighbourhood to promote active living

    Pawlowski, Charlotte Skau; Winge, Laura; Carroll, Sidse

    BACKGROUND: A limited amount of research has examined the effect of changing public open spaces on active living. This abstract presents the study protocol of an intervention study designed in an interdisciplinary collaboration built on principles of Community-Based Participatory Research (CBPR......) to develop urban installations highly tailored to promote active living among children (10-13-years-old) and seniors (>60-years-old) in a deprived neighbourhood in Copenhagen. METHODS: The study builds on a quasi-experimental study design including two sub-studies: 1) a children study and 2) a senior study....... During spring 2017 the interventions will be developed, designed and implemented in collaboration with local children and seniors, respectively, using different co-design tools and methods. We will evaluate the effect of the interventions on children’s and senior’s use of the new-built urban...

  4. Sex differences in risk factors for retinopathy in non-diabetic men and women: The Tromso Eye Study

    Bertelsen, G.; Peto, T.; Lindekleiv, H.

    2014-01-01

    Purpose: To determine the prevalence and risk factors for retinopathy in a nondiabetic population. Methods: The study population included 5869 participants without diabetes aged 38-87years from the TromsO Eye Study, a substudy of the population-based TromsO Study in Norway. Retinal images from both...... eyes were graded for retinopathy. We collected data on risk factors from self-report questionnaires, clinical examinations, laboratory measurements and case note reviews. The cross-sectional relationship between potential risk factors and retinopathy was assessed using logistic regression analysis...... excretion (urinary albumin/creatinine ratio >0.43mg/mmol). Conclusion: This study confirms results from previous studies on the strong association between blood pressure and retinopathy. A novel finding is the sex differences in risk factors for retinopathy, suggesting a sex difference in the pathogenesis...

  5. Impact of mean arterial pressure on sublingual microcirculation during cardiopulmonary bypass - secondary outcome from a randomised clinical trial

    Holmgaard, Frederik; Vedel, Anne G; Ravn, Hanne Berg

    2018-01-01

    . METHODS: Thirty-six cardiac surgery patients undergoing coronary artery bypass grafting were included and randomised to either low (40-50 mmHg) or high (70-80 mmHg) mean arterial pressure during cardiopulmonary bypass. Sidestream Dark Field video images were recorded from the sublingual mucosa. Recordings...... were analysed in a blinded fashion to quantify microcirculatory variables. RESULTS: Mean arterial pressure during cardiopulmonary bypass in the low target group was 45.0 mmHg (SD 5.3) vs. 67.2 mmHg (SD 8.9) in the high target group. We found no significant difference between the two groups......OBJECTIVE: In this substudy of a randomised, clinical trial, we explored the sublingual microcirculation during cardiac surgery at two different levels of blood pressure. We hypothesised that a higher mean arterial pressure during cardiopulmonary bypass would cause higher Microvascular Flow Index...

  6. Toward a bioethical framework for antibiotic use, antimicrobial resistance and for empirically designing ethically robust strategies to protect human health: a research protocol.

    Hernández-Marrero, Pablo; Martins Pereira, Sandra; de Sá Brandão, Patrícia Joana; Araújo, Joana; Carvalho, Ana Sofia

    2017-12-01

    Introduction Antimicrobial resistance (AMR) is a challenging global and public health issue, raising bioethical challenges, considerations and strategies. Objectives This research protocol presents a conceptual model leading to formulating an empirically based bioethics framework for antibiotic use, AMR and designing ethically robust strategies to protect human health. Methods Mixed methods research will be used and operationalized into five substudies. The bioethical framework will encompass and integrate two theoretical models: global bioethics and ethical decision-making. Results Being a study protocol, this article reports on planned and ongoing research. Conclusions Based on data collection, future findings and using a comprehensive, integrative, evidence-based approach, a step-by-step bioethical framework will be developed for (i) responsible use of antibiotics in healthcare and (ii) design of strategies to decrease AMR. This will entail the analysis and interpretation of approaches from several bioethical theories, including deontological and consequentialist approaches, and the implications of uncertainty to these approaches.

  7. The evaluation of subcutaneous proleukin (interleukin-2) in a randomized international trial: rationale, design, and methods of ESPRIT.

    Emery, Sean; Abrams, Donald I; Cooper, David A; Darbyshire, Janet H; Lane, H Clifford; Lundgren, Jens D; Neaton, James D

    2002-04-01

    The Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT) is a large ongoing randomized trial of subcutaneous interleukin-2 (IL-2) plus antiretroviral therapy versus antiretroviral therapy alone in patients with HIV (human immunodeficiency virus) disease and CD4 cell counts of at least 300 cells/mm(3). The primary objective is to determine whether the addition of IL-2 to combination antiretroviral therapy improves morbidity and mortality. The aim is to recruit 4000 participants and follow them for an average of 5 years. Eligible subjects will be recruited at 275 investigational sites in 23 countries around the world. Coupled with broad eligibility criteria this will ensure widely applicable results. A range of secondary objectives will also be addressed in this setting that will include the conduct of observational studies and nested substudies with a public health focus. This article describes the rationale supporting the trial in addition to reviewing the study design, coordination, and governance.

  8. The Tromsø Eye Study

    Bertelsen, Geir; Erke, Maja G; von Hanno, Therese

    2013-01-01

    Purpose:  To describe the study design and methodology of the Tromsø Eye Study (TES), and to describe visual acuity and refractive error in the study population. Methods:  The Tromsø Eye Study is a sub-study of the Tromsø Study, a population-based multipurpose longitudinal study in the municipality...... of Tromsø, Norway. The Tromsø Eye Study was a part of the sixth survey of the Tromsø Study, conducted from October 2007 through December 2008. The eye examination included information on self-reported eye diseases, assessment of visual acuity and refractive errors, retinal photography and optical coherence...

  9. Workplace Re-organization and Changes in Physiological Stress Markers

    Carlsson, Rikke Hinge; Hansen, Åse Marie; Kristiansen, Jesper

    2014-01-01

    The aim of this study was to investigate changes in physiological stress markers as a consequence of workplace reorganization. Moreover, we aimed to investigate changes in the psychosocial work environment (job strain, effortreward imbalance (ERI), in psychological distress (stress symptoms......, perceived stress) and the mediating effect of these factors on changes in physiological stress markers. We used data from a longitudinal study that studied the health consequences of a major reorganization of non-state public offices executed in Denmark on 1 January 2007. Collection of clinical...... and questionnaire data was in 2006 and 2008, and in this sub-study we included 359 participants. To reflect stress reactions of the autonomic nervous system, the endocrine system and the immune system, we included 13 physiological markers. We observed significant change in several physiological stress markers...

  10. Chronic obstructive pulmonary disease in patients admitted with heart failure

    Iversen, K K; Kjaergaard, J; Akkan, D

    2008-01-01

    OBJECTIVE: Chronic obstructive pulmonary disease (COPD) is an important differential diagnosis in patients with heart failure (HF). The primary aims were to determine the prevalence of COPD and to test the accuracy of self-reported COPD in patients admitted with HF. Secondary aims were to study...... valve. CONCLUSION: Chronic obstructive pulmonary disease is frequent in patients admitted with HF and self-reported COPD only identifies a minority. The prevalence of COPD was high in both patients with systolic and nonsystolic HF....... a possible relationship between right and left ventricular function and pulmonary function. DESIGN: Prospective substudy. SETTING: Systematic screening at 11 centres. SUBJECTS: Consecutive patients (n = 532) admitted with HF requiring medical treatment with diuretics and an episode with symptoms...

  11. Effect of Insulin Analogs on Frequency of Non-Severe Hypoglycemia in Patients with Type 1 Diabetes Prone to Severe Hypoglycemia

    Agesen, Rikke Mette; Kristensen, Peter Lommer; Beck-Nielsen, Henning

    2018-01-01

    -monitoring of blood glucose (SMBG) in patients with type 1 diabetes and recurrent severe hypoglycemia. Methods: Fifty-three patients completed a substudy of 4 × 3 days of blinded CGM. CGM traces were reviewed for hypoglycemic events lasting 15 min or longer. Results: At the threshold ≤3.9 mmol/L, the per......Background: Hypoglycemia is an increasingly important endpoint in clinical diabetes trials. The assessment of hypoglycemia should therefore be as complete as possible. Blinded continuous glucose monitoring (CGM) provides an improved opportunity to capture asymptomatic and nocturnal events. Here we...... times shorter using CGM data than SMBG data (1.4 vs. 47 weeks). Conclusions: Capturing hypoglycemic events by the conventional method of SMBG in patients with impaired awareness reveals only a limited number of events. Blinded CGM can provide more complete data, particularly in terms of asymptomatic...

  12. The effect of oral immunomodulatory therapy on treatment uptake and persistence in multiple sclerosis.

    Warrender-Sparkes, Matthew; Spelman, Tim; Izquierdo, Guillermo; Trojano, Maria; Lugaresi, Alessandra; Grand'Maison, François; Havrdova, Eva; Horakova, Dana; Boz, Cavit; Oreja-Guevara, Celia; Alroughani, Raed; Iuliano, Gerardo; Duquette, Pierre; Girard, Marc; Terzi, Murat; Hupperts, Raymond; Grammond, Pierre; Petersen, Thor; Fernandez-Bolaños, Ricardo; Fiol, Marcela; Pucci, Eugenio; Lechner-Scott, Jeannette; Verheul, Freek; Cristiano, Edgardo; Van Pesch, Vincent; Petkovska-Boskova, Tatjana; Moore, Fraser; Kister, Ilya; Bergamaschi, Roberto; Saladino, Maria Laura; Slee, Mark; Barnett, Michael; Amato, Maria Pia; Shaw, Cameron; Shuey, Neil; Young, Carolyn; Gray, Orla; Kappos, Ludwig; Butzkueven, Helmut; Kalincik, Tomas; Jokubaitis, Vilija

    2016-04-01

    We aimed to analyse the effect of the introduction of fingolimod, the first oral disease-modifying therapy, on treatment utilisation and persistence in an international cohort of patients with multiple sclerosis (MS). MSBASIS, a prospective, observational sub-study of the MSBase registry, collects demographic, clinical and paraclinical data on patients followed from MS onset (n=4718). We conducted a multivariable conditional risk set survival analysis to identify predictors of treatment discontinuation, and to assess if the introduction of fingolimod has altered treatment persistence. A total of 2640 patients commenced immunomodulatory therapy. Following the introduction of fingolimod, patients were more likely to discontinue all other treatments (hazard ratio 1.64, ptreatment compared with other therapies (ptreatment discontinuation. Following the availability of fingolimod, patients were more likely to discontinue injectable treatments. Those who switched to fingolimod were more likely to do so for convenience. Persistence was improved on fingolimod compared to other medications. © The Author(s), 2015.

  13. The effect of proteins from animal source foods on heme iron bioavailability in humans.

    Pizarro, Fernando; Olivares, Manuel; Valenzuela, Carolina; Brito, Alex; Weinborn, Valerie; Flores, Sebastián; Arredondo, Miguel

    2016-04-01

    Forty-five women (35-45 year) were randomly assigned to three iron (Fe) absorption sub-studies, which measured the effects of dietary animal proteins on the absorption of heme Fe. Study 1 was focused on heme, red blood cell concentrate (RBCC), hemoglobin (Hb), RBCC+beef meat; study 2 on heme, heme+fish, chicken, and beef; and study 3 on heme and heme+purified animal protein (casein, collagen, albumin). Study 1: the bioavailability of heme Fe from Hb was similar to heme only (∼13.0%). RBCC (25.0%) and RBCC+beef (21.3%) were found to be increased 2- and 1.6-fold, respectively, when compared with heme alone (pProteins from animal source foods and their digestion products did not enhance heme Fe absorption. Copyright © 2015. Published by Elsevier Ltd.

  14. How Do the Approaches to Accountability Compare for Charities Working in International Development?

    Kirsch, David

    2014-01-01

    Approaches to accountability vary between charities working to reduce under-five mortality in underdeveloped countries, and healthcare workers and facilities in Canada. Comparison reveals key differences, similarities and trade-offs. For example, while health professionals are governed by legislation and healthcare facilities have a de facto obligation to be accredited, charities and other international organizations are not subject to mandatory international laws or guidelines or to de facto international standards. Charities have policy goals similar to those found in the Canadian substudies, including access, quality, cost control, cost-effectiveness and customer satisfaction. However, the relative absence of external policy tools means that these goals may not be realized. Accountability can be beneficial, but too much or the wrong kind of accountability can divert resources and diminish returns. PMID:25305397

  15. Early phase II study on BNCT in metastatic malignant melanoma using the boron carrier BPA (EORTC protocol 11011)

    Wittig, Andrea; Sauerwein, Wolfgang; Moss, Raymond

    2006-01-01

    The aim of the trial is to examine the clinical response of metastatic melanoma following BNCT with BPA. The trial contains an optional biodistribution sub-study, which is done if operable metastases are removed prior BNCT. BNCT is applied in 2 fractions at the HFR in Petten. In cases of diffuse brain metastases the whole brain is irradiated homogeneously using 5 irradiation beams from different directions. Up to now 4 patients suffering from multiple brain metastases (more than 20) have been included. In all cases we observed a partial response or no change in the irradiated volume. However, none of the patients survived more than 3 months. The pharmacokinetic of the BPA can be predicted very precisely using a two-compartment model. The treatment can be performed safety. (author)

  16. The impact of self-efficacy on physical activity maintenance in patients with hip osteoarthritis

    Hammer, Nanna Maria; Bieler, Theresa; Beyer, Nina Ann-Marie

    2016-01-01

    Purpose: Understanding motivational factors related to physical activity (PA) maintenance is essential in promoting long-term exercise benefits. This study explored the impact of self-efficacy (SE) on post-intervention PA maintenance in patients with hip osteoarthritis. Method: An SE-theory based...... mixed-methods sub-study of a trial investigating the effects of 4 months supervised exercise in patients with hip osteoarthritis. Questionnaire data (n = 52; baseline and 12 months) on PA and SE (Arthritis Self-Efficacy Scale, ASES, score-range 10–100) were analysed (Mann–Whitney test) for differences...... from incorporating the self-efficacy theory in the planning and execution of exercise interventions to promote post-intervention physical activity maintenance and long term health benefits. •Post-intervention physical activity maintenance may be increased by focussing on the patients’ exercise self-efficacy...

  17. Analysis of neurocognitive function and CNS endpoints in the PROTEA trial

    Clarke, Amanda; Johanssen, Veronika; Gerstoft, Jan

    2014-01-01

    INTRODUCTION: During treatment with protease inhibitor monotherapy, the number of antiretrovirals with therapeutic concentrations in the cerebrospinal fluid (CSF) is lower, compared to standard triple therapy. However, the clinical consequences are unclear. METHODS: A total of 273 patients with HIV...... and the Grooved Pegboard Test at screening, baseline and at Week 48. A global neurocognitive score (NPZ-5) was derived by averaging the standardized results of the five domains. In a central nervous system (CNS) sub-study (n=70), HIV RNA levels in the CNS were evaluated at baseline and Week 48. Clinical adverse...... events related to the CNS were collected at each visit. RESULTS: Patients were 83% male and 88% White, with median age 43 years. There were more patients with nadir CD4 count below 200 cells/µL in the DRV/r monotherapy arm (41/137, 30%) than the triple therapy arm (30/136, 22%). At Week 48...

  18. The relationship of hip joint space to self reported hip pain

    Jacobsen, S.; Holm, S.S.; Lund, B.

    2004-01-01

    OBJECTIVES: (1) To evaluate the effect of pelvic orientation on measurements of hip joint space widths (JSW) in cadaver pelvic radiographs, thereby validating the pelvic radiographs of the Copenhagen City Heart Study: The Osteoarthritis Substudy (CCHS III) cohort of 4.152 subjects, and (2......) to investigate the relationship between minimal JSW and self reported hip pain of the cohort. METHODS: (1) Cadaver pelves and proximal femora of one male and one female donor were mounted in holding devices permitting independent rotation (total arc of 42 degrees), and inclination/reclination (total arc of 24...... degrees). At each 3 degrees increment an anteroposterior radiograph was recorded. Measurements of JSW were performed. (2) Self reported recurrent pain in or around the hip joint during 12 months prior to baseline examinations, and minimum JSW in pelvic radiographs of the cohort were registered...

  19. Patients' experiences of postoperative intermediate care and standard surgical ward care after emergency abdominal surgery

    Thomsen, Thordis; Vester-Andersen, Morten; Nielsen, Martin Vedel

    2015-01-01

    AIMS AND OBJECTIVES: To elicit knowledge of patient experiences of postoperative intermediate care in an intensive care unit and standard postoperative care in a surgical ward after emergency abdominal surgery. BACKGROUND: Emergency abdominal surgery is common, but little is known about how patie......, intermediate care patients felt hindered in doing so by continuous monitoring of vital signs. RELEVANCE TO CLINICAL PRACTICE: Intermediate care may increase patient perceptions of quality and safety of care.......AIMS AND OBJECTIVES: To elicit knowledge of patient experiences of postoperative intermediate care in an intensive care unit and standard postoperative care in a surgical ward after emergency abdominal surgery. BACKGROUND: Emergency abdominal surgery is common, but little is known about how...... patients experience postoperative care. The patient population is generally older with multiple comorbidities, and the short-term postoperative mortality rate is 15-20%. Thus, vigilant surgeon and nursing attention is essential. The present study is a qualitative sub-study of a randomised trial evaluating...

  20. Fixed-dose combination therapy of nebivolol and valsartan for the treatment of hypertension.

    Sander, Gary E; Fernandez, Camilo; Giles, Thomas D

    2016-01-01

    Recent large clinical trials have refuted earlier suggestions from the Joint National Committee 8 committee that less aggressive targets for blood pressure control were all that could be justified in most hypertensive patients. It now does appear that in fact "lower is better," with blood pressure targets valsartan, an angiotensin II subtype 1 receptor blocker, were more effective in reducing blood pressure than the corresponding monotherapies, with comparable tolerability. In addition, an ABPM-biomarkers substudy from that trial (n=805) demonstrated that the FDC prevented a valsartan-induced increase in plasma renin activity, and that the nebivolol/valsartan 20/320 mg/day dose reduced plasma aldosterone concentration significantly more than valsartan 320 mg/day. This article will describe the properties of nebivolol that make it unique and separate it from other β-blockers, and will further support the pharmacological advantages of this particular combination.

  1. The HF epidemic: the need for new treatment strategies

    Peter E Carson

    2000-06-01

    Full Text Available The incidence of heart failure is increasing, particularly in older patients. Clinical trials often do not reflect community practice where patients are older and have more co-morbid conditions. Therapeutic agents need to be at least neutral in their effects on these other conditions. Current therapy in heart failure includes angiotensin-converting enzyme (ACE inhibitors, beta-blockers and diuretics, with advanced heart failure patients receiving spironolactone and possibly digitalis. Ongoing clinical trials are testing more effective inhibition of the renin-angiotensin-aldosterone system (RAAS with highly selective angiotensin II (Ang II receptor blockers (ARBs such as valsartan. Future trials should study diverse racial groups and the elderly, particularly those with preserved systolic function. These should ideally be large multicentre studies with internal substudies to examine mechanisms of heart failure.

  2. Impact of acute hyperglycemia on myocardial infarct size, area at risk and salvage in patients with ST elevation myocardial infarction and the association with exenatide treatment - results from a randomized study

    Lønborg, Jacob Thomsen; Vejlstrup, Niels Grove; Kelbæk, Henning Skov

    2014-01-01

    Hyperglycemia upon hospital admission in patients with ST-segment elevation myocardial infarction (STEMI) occurs frequently and is associated with adverse outcomes. It is, however, unsettled as to whether an elevated blood glucose level is the cause or consequence of increased myocardial damage....... In addition, whether the cardioprotective effect of exenatide, a glucose-lowering drug, is dependent on hyperglycemia remains unknown. The objectives of this substudy were to evaluate the association between hyperglycemia and infarct size, myocardial salvage, and area at risk, and to assess the interaction...... between exenatide and hyperglycemia. A total of 210 STEMI patients were randomized to receive intravenous exenatide or placebo before percutaneous coronary intervention. Hyperglycemia was associated with larger area at risk and infarct size compared with patients with normoglycemia, but the salvage index...

  3. Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan

    Ovesen, Christian; Jakobsen, Janus Christian; Gluud, Christian

    2018-01-01

    OBJECTIVE: We present the statistical analysis plan of a prespecified Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 sub-study aiming to investigate, if tranexamic acid has a different effect in intracerebral haemorrhage patients with the spot sign on admission compared...... to spot sign negative patients. The TICH-2 trial recruited above 2000 participants with intracerebral haemorrhage arriving in hospital within 8 h after symptom onset. They were included irrespective of radiological signs of on-going haematoma expansion. Participants were randomised to tranexamic acid...... versus matching placebo. In this subgroup analysis, we will include all participants in TICH-2 with a computed tomography angiography on admission allowing adjudication of the participants' spot sign status. RESULTS: Primary outcome will be the ability of tranexamic acid to limit absolute haematoma...

  4. Encounters with medicines among ethnic minorities with chronic conditions

    Mygind, Anna

    of the study was to explore the challenges of encounters with medicines among ethnic minorities with chronic conditions in Denmark, exemplified by policy, professional and patient perspectives. Implications for community pharmacies was a particular focus. Methods: The study drew on different methods, types...... analysis of interviews with people with Pakistani background, type 2 diabetes and at least one other chronic condition, focusing on lived experiences with medicine use during Ramadan, reasons for fasting, and experiences with counselling on medicines. Sub-study IV encompassed an analysis of interviews......-study I. Most documents agreed that skin colour and skin covering were part of the definition of ethnic minorities at risk. Major discrepancies were found regarding the importance attributed to the Islamic religion, other traditions, immigration, gender and age, and an evolutionary explanation...

  5. The Effect of Campaign-Generated Interpersonal Communication on Campaign-Targeted Health Outcomes: A Meta-Analysis.

    Jeong, Michelle; Bae, Rosie Eungyuhl

    2017-06-16

    This study examined the effect of mass media campaign-generated conversations on campaign-targeted health outcomes, via a systematic meta-analysis of 28 studies (including 124 sub-studies and a total of 138,898 participants). The study also conducted a series of moderation analyses to examine the conditions under which interpersonal communication has larger effects on bringing about the desired outcomes. The findings of this meta-analysis indicate that campaign-generated conversations have a positive effect on inducing campaign-targeted outcomes (OR = 1.28) and show that this effect is moderated by health topic addressed by the campaign, the type of outcome being targeted by the campaign, and with whom people converse, along with several other campaign-relevant and study-relevant variables. The implications of these findings for future research are discussed.

  6. Clinical Aspects of Hypoxia-inducible Factors in Colorectal Cancer

    Havelund, Birgitte Mayland; Spindler, Karen-Lise Garm; Sørensen, Flemming Brandt

    Clinical Aspects of Hypoxia-inducible Factors in Colorectal Cancer  Birgitte Mayland Havelund1,4 MD, Karen-Lise Garm Spindler1,4 MD, PhD, Flemming Brandt Sørensen2,4 MD, DMSc, Ivan Brandslund3 MD, DMSc, Anders Jakobsen1,4 MD, DMSc.1Department of Oncology, 2Pathology and 3Biochemistry, Vejle...... activates transcription of numerous genes associated with angiogenesis, ATP-metabolism, cell-proliferation, glycolysis and apoptosis. HIF-1α is over expressed in many malignant tumors and is reported to play an important role in tumor invasion and progression. The aim of this Ph.D. project is to investigate...... the predictive and prognostic value of HIF-1α in colorectal cancer.Materials and MethodsThe project is divided into 3 substudies:1. Biological and methodological aspects. The expression of HIF-1α measured by immunohistochemistry in paraffin embedded tissue is related to single nucleotide polymorphism (SNP...

  7. Ceramide content is higher in type I compared to type II fibers in obesity and type 2 diabetes mellitus

    Kristensen, Ditte Bech; Prats Gavalda, Clara; Larsen, Steen

    2012-01-01

    This study investigated fiber-type-specific muscle ceramide content in obese subjects and type 2 diabetes patients. Two substudies, one which compared type 2 diabetes patients to both lean- and obese BMI-matched subjects and the other study which compared lean body-matched post-obese, obese......, and control subjects, were performed. A fasting blood sample was obtained and plasma insulin and glucose determined. A muscle biopsy was obtained from deltoideus and vastus lateralis, and fiber-type ceramide content was determined by fluorescence immunohistochemistry. Insulin sensitivity estimated by Quicki...... index was higher in lean compared to type 2 diabetes patients and obese controls. Also in control and post-obese subjects, a higher insulin sensitivity was observed compared to obese subjects. Ceramide content was consistently higher in type I than in type II muscle fibers and higher in deltoideus than...

  8. Danish Patients are positive towards fees for non-attendance in public hospitals

    Lou, Stina; Frumer, Michal; Olesen, Steen

    2016-01-01

    Introduction: Patients’ non-attendance is a significant problem in modern healthcare. Non-attendance delays treatment, reduces efficiency and increases healthcare costs. For several years, the introduction of financial incentives such as a non-attendance fee has been discussed in Denmark. Set...... in the context of a tax-financed, free-for-all healthcare system, the political hesitance to introduce fees relates to concerns that additional fees may be badly received by tax-paying citizens and may undermine the polit­ical priority of patient equity. The aim of this qualitative sub-study was to investigate...... patients’ attitudes towards a fee for non-attendance. Methods: Six semi-structured focus group interviews were conducted with a total of 44 patients who had been informed about being charged a fee for non-attendance. Data were transcribed verbatim and analysed using a qualitative content analysis. Results...

  9. Effects of Lifestyle on Muscle Strength in a Healthy Danish Population

    Bartels, Else Marie; Robertson, Samuel; Danneskiold-Samsøe, Bente

    2018-01-01

    The Copenhagen City Heart Study (CCHS) and measurements of Isokinetic muscle strength from a sub-study of randomly selected healthy participants from CCHS. Methods: 126 women and 63 men were studied. All participants completed a questionnaire regarding their lifestyle, including physical activity, alcohol intake...... in the lower extremities (p = 0.03) for women, and lower extremities (p = 0.03) and trunk (p = 0.007) for men. Alcohol Intake was in general not correlated to muscle strength. No clear effect of smoking was seen on muscle strength. Conclusion: Our results show that physical activity during leisure...... and smoking habits. Isokinetic muscle strength was measured over the upper extremities (UE), trunk, and lower extremities (LE). Multivariate analyses including all of the variables were carried out. Results: The level of daily physical activity during leisure was positively correlated to muscle strength...

  10. Effects of Lifestyle on Muscle Strength in a Healthy Danish Population

    Bartels, Else Marie; Robertson, Samuel; Danneskiold-Samsøe, Bente

    2018-01-01

    The Copenhagen City Heart Study (CCHS) and measurements of Isokinetic muscle strength from a sub-study of randomly selected healthy participants from CCHS. Methods: 126 women and 63 men were studied. All participants completed a questionnaire regarding their lifestyle, including physical activity, alcohol intake...... in the lower extremities (p = 0.03) for women, and lower extremities (p = 0.03) and trunk (p = 0.007) for men. Alcohol Intake was in general not correlated to muscle strength. No clear effect of smoking was seen on muscle strength. Conclusions: Our results show that physical activity during leisure...... and smoking habits. Isokinetic muscle strength was measured over the upper extremities (UE), trunk, and lower extremities (LE). Multivariate analyses including all of the variables were carried out. Results: The level of daily physical activity during leisure was positively correlated to muscle strength...

  11. The association between Bacillus Calmette-Guérin vaccination (1331 SSI) skin reaction and subsequent scar development in infants

    Birk, Nina Marie; Nissen, Thomas Nørrelykke; Ladekarl, Monica

    2017-01-01

    BACKGROUND: The Bacillus Calmette-Guérin vaccine (BCG) against tuberculosis is administered intradermally, and vaccination is often followed by a scar at the injection site. Among BCG-vaccinated individuals, having a scar has been associated with lower mortality. We aimed to examine the impact...... of vaccination technique for scarring in a high income setting, by assessing the associations between the post injection reaction, the wheal size, and the probability of developing a scar, and scar size. METHODS: This study was nested within a clinical multicenter study randomizing 4262 infants to either BCG...... vaccination (BCG 1331 SSI) or no intervention. In this substudy, including 492 vaccinated infants, the immediate post BCG vaccination reaction was registered as either wheal (a raised, blanched papule at the injection site), bulge (a palpable element at the injection site), or no reaction. The presence...

  12. Methodological aspects of the 1993 Pelotas (Brazil) Birth Cohort Study

    Victora, Cesar Gomes; Araújo, Cora Luiza Pavin; Menezes, Ana Maria Batista; Hallal, Pedro Curi; Vieira, Maria de Fátima; Neutzling, Marilda Borges; Gonçalves, Helen; Valle, Neiva Cristina; Lima, Rosangela Costa; Anselmi, Luciana; Behague, Dominique; Gigante, Denise Petrucci; Barros, Fernando Celso

    2010-01-01

    This paper describes the main methodological aspects of a cohort study, with emphasis on its recent phases, which may be relevant to investigators planning to carry out similar studies. In 1993, a population based study was launched in Pelotas, Southern Brazil. All 5,249 newborns delivered in the city’s hospitals were enrolled, and sub-samples were visited at the ages of one, three and six months and of one and four years. In 2004-5 it was possible to trace 87.5% of the cohort at the age of 10-12 years. Sub-studies are addressing issues related to oral health, psychological development and mental health, body composition, and ethnography. Birth cohort studies are essential for investigating the early determinants of adult disease and nutritional status, yet few such studies are available from low and middle-income countries where these determinants may differ from those documented in more developed settings. PMID:16410981

  13. Fatherhood in adolescence: prevalence and associated factors in a community sample of youngsters

    Milene Maria Saalfeld de Oliveira

    2015-11-01

    Full Text Available This article aims to assess the prevalence of fatherhood in adolescence (FA and associated factors in a community sample of 14 to 35 year-old men. Cross-sectional population-based study realized in the urban area of the city of Pelotas-RS, Brazil. The sample was selected by clusters, according to the city census. This sub-study only comprised sexually active men. Data were collected using a self-administered questionnaire in the participants’ homes. The sample was composed for 934 men. The prevalence of fatherhood in adolescence was 8% (n = 75. We verified higher prevalence of FA among those that reported paternal absence (p < 0.001, those that had lived with stepfather (p = 0.044, and among those that had sexual debut before the age of 14 (p = 0.011. Paternal absence, have lived with a stepfather, and early sexual experience are associated factors to fatherhood in adolescence.

  14. Effect of verapamil on heart rate variability after an acute myocardial infarction. Danish Verapamil Infarction Trial II

    Vaage-Nilsen, M; Rasmussen, Verner

    1998-01-01

    with verapamil significantly reduced sudden death, the aim of the present substudy was to evaluate the effect of verapamil on heart-rate variability in the time and frequency domain, measured in two 5-minute segments during the day and night. Thirty-eight patients were examined by Holter monitoring, at 1 week......-16 months of treatment. In accord with the known reduction of overall heart rate by verapamil, a significant increase of mean NN interval from before to after 1 (P = 0.0004) and 12-16 months (P = 0.004) of treatment was seen in the verapamil, but not in the placebo, group at night. Parameters generally......, the present study indicates that verapamil shifts the autonomic balance to a vagal preponderance or sympathetic attenuation in the postinfarction period....

  15. The cost-effectiveness of radiofrequency catheter ablation as first-line treatment for paroxysmal atrial fibrillation

    Aronsson, Mattias; Walfridsson, Håkan; Janzon, Magnus

    2014-01-01

    AIM: The aim of this prospective substudy was to estimate the cost-effectiveness of treating paroxysmal atrial fibrillation (AF) with radiofrequency catheter ablation (RFA) compared with antiarrhythmic drugs (AADs) as first-line treatment. METHODS AND RESULTS: A decision-analytic Markov model......, based on MANTRA-PAF (Medical Antiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation) study data, was developed to study long-term effects and costs of RFA compared with AADs as first-line treatment. Positive clinical effects were found in the overall population, a gain...... of an average 0.06 quality-adjusted life years (QALYs) to an incremental cost of €3033, resulting in an incremental cost-effectiveness ratio of €50 570/QALY. However, the result of the subgroup analyses showed that RFA was less costly and more effective in younger patients. This implied an incremental cost-effectiveness...

  16. Cardiovascular risk factors associated with lower baseline cognitive performance in HIV-positive persons.

    Wright, E J; Grund, B; Robertson, K; Brew, B J; Roediger, M; Bain, M P; Drummond, F; Vjecha, M J; Hoy, J; Miller, C; Penalva de Oliveira, A C; Pumpradit, W; Shlay, J C; El-Sadr, W; Price, R W

    2010-09-07

    To determine factors associated with baseline neurocognitive performance in HIV-infected participants enrolled in the Strategies for Management of Antiretroviral Therapy (SMART) neurology substudy. Participants from Australia, North America, Brazil, and Thailand were administered a 5-test neurocognitive battery. Z scores and the neurocognitive performance outcome measure, the quantitative neurocognitive performance z score (QNPZ-5), were calculated using US norms. Neurocognitive impairment was defined as z scores penetration effectiveness rank of antiretroviral regimens were not. In this HIV-positive population with high CD4 cell counts, neurocognitive impairment was associated with prior CVD. Lower neurocognitive performance was associated with prior CVD, hypertension, and hypercholesterolemia, but not conventional HAD risk factors. The contribution of CVD and cardiovascular risk factors to the neurocognition of HIV-positive populations warrants further investigation.

  17. Circadian rhythm and the influence of physical activity on circulating surfactant protein D in early and long-standing rheumatoid arthritis

    Christensen, A F; Hoegh, S V; Lottenburger, T

    2011-01-01

    Surfactant protein D (SP-D) belongs to the collectin family and has pro-and anti-inflammatory capacities depending on its oligomerization. Previously, circulating SP-D was shown to be decreased in early rheumatoid arthritis (RA) and negatively correlated to disease activity. This study aimed...... at assessing the diurnal rhythmicity and the influence of physical activity on circulating SP-D in patients with RA at different stages compared with healthy individuals. Patients with early RA (ERA) with disease duration ... in two sub-studies. Healthy individuals served as controls. Diurnal variation: blood samples were collected every 3 h from 7 a.m to 10 p.m and the following morning. Physical activity: blood sampling was done before and after standardized physical challenge. SP-D was measured by ELISA. SP-D exhibited...

  18. The HF epidemic: The need for new treatment strategies

    Peter E Carson

    2000-06-01

    Full Text Available Summary The incidence of heart failure is increasing, particularly in older patients. Clinical trials often do not reflect community practice where patients are older and have more co-morbid conditions. Therapeutic agents need to be at least neutral in their effects on these other conditions. Current therapy in heart failure includes angiotensin-converting enzyme (ACE inhibitors, beta-blockers and diuretics, with advanced heart failure patients receiving spironolactone and possibly digitalis. Ongoing clinical trials are testing more effective inhibition of the renin-angiotensin-aldosterone system (RAAS with highly selective angiotensin II (Ang II receptor blockers (ARBs such as valsartan. Future trials should study diverse racial groups and the elderly, particularly those with preserved systolic function. These should ideally be large multicentre studies with internal substudies to examine mechanisms of heart failure.

  19. Left atrial systolic force in hypertensive patients with left ventricular hypertrophy: the LIFE study

    Chinali, M.; Simone, G. de; Wachtell, K.

    2008-01-01

    In hypertensive patients without prevalent cardiovascular disease, enhanced left atrial systolic force is associated with left ventricular hypertrophy and increased preload. It also predicts cardiovascular events in a population with high prevalence of obesity. Relations between left atrial...... systolic force and left ventricular geometry and function have not been investigated in high-risk hypertrophic hypertensive patients. Participants in the Losartan Intervention For Endpoint reduction in hypertension echocardiography substudy without prevalent cardiovascular disease or atrial fibrillation (n...... = 567) underwent standard Doppler echocardiography. Left atrial systolic force was obtained from the mitral orifice area and Doppler mitral peak A velocity. Patients were divided into groups with normal or increased left atrial systolic force (>14.33 kdyn). Left atrial systolic force was high in 297...

  20. Visceral fat is associated with brain structure independent of human immunodeficiency virus infection status.

    Lake, Jordan E; Popov, Mikhail; Post, Wendy S; Palella, Frank J; Sacktor, Ned; Miller, Eric N; Brown, Todd T; Becker, James T

    2017-06-01

    The combined effects of human immunodeficiency virus (HIV), obesity, and elevated visceral adipose tissue (VAT) on brain structure are unknown. In a cross-sectional analysis of Multicenter AIDS Cohort Study (MACS) participants, we determined associations between HIV serostatus, adiposity, and brain structure. Men (133 HIV+, 84 HIV-) in the MACS Cardiovascular 2 and magnetic resonance imaging (MRI) sub-studies with CT-quantified VAT and whole brain MRI measured within 1 year were assessed. Voxel-based morphometry analyzed brain volumes. Men were stratified by elevated (eVAT, ≥100cm 2 ) or "normal" (nVAT, 25 kg/m 2 , smaller gray and white matter volumes, and larger cerebrospinal fluid volume than nVAT men. In multivariate analysis, hypertension, higher adiponectin, higher interleukin-6, age, diabetes mellitus, higher body mass index, and eVAT were associated with brain atrophy (p central nervous system effects may be amplified in this population.

  1. Pulmonary effects of immediate versus deferred antiretroviral therapy in HIV-positive individuals

    Kunisaki, Ken M; Niewoehner, Dennis E; Collins, Gary

    2016-01-01

    BACKGROUND: Observational data have been conflicted regarding the potential role of HIV antiretroviral therapy (ART) as a causative factor for, or protective factor against, COPD. We therefore aimed to investigate the effect of immediate versus deferred ART on decline in lung function in HIV...... Services guidelines) either immediately, or deferred until CD4 T-cell counts decreased to 350 per μL or AIDS developed. The randomisation was determined by participation in the parent START study, and was not specific to the substudy. Because of the nature of our study, site investigators and participants...... were not masked to the treatment group assignment; however, the assessors who reviewed the outcomes were masked to the treatment group. The primary outcome was the annual rate of decline in lung function, expressed as the FEV1 slope in mL/year; spirometry was done annually during follow-up for up to 5...

  2. Dental pulp-derived stromal cells exhibit a higher osteogenic potency than bone marrow-derived stromal cells in vitro and in a porcine critical-size bone defect model

    Jensen, Jonas; Tvedesøe, Claus; Rölfing, Jan Hendrik Duedal

    2016-01-01

    marrow and the molar teeth of each pig, respectively. BMSCs and DPSCs were cultured in monolayer and on a three-dimensional (3D) polycaprolactone (PCL) - hyaluronic acid - tricalcium phosphate (HT-PCL) scaffold. Population doubling (PD), alkaline phosphatase (ALP) activity, and calcium deposition were...... measured in monolayer. In the 3D culture ALP activity, DNA content, and calcium deposition were evaluated. Six non-penetrating critical-size defects were made in each calvarium of 14 pigs. Three paired sub-studies were conducted: (1) empty defects vs. HT-PCL scaffolds; (2) PCL scaffolds vs. HT...... a higher ALP activity and calcium deposition of the DPSC cultures compared with BMSC cultures. Significantly more bone was present in the HT-PCL group than in both the pure PCL scaffold group and the empty defect group in vivo. DPSCs generated more bone than BMSCs when seeded on HT-PCL. In conclusion...

  3. Invasive Candida Infections and the Harm From Antibacterial Drugs in Critically Ill Patients: Data From a Randomized, Controlled Trial to Determine the Role of Ciprofloxacin, Piperacillin-Tazobactam, Meropenem, and Cefuroxime

    Jensen, Jens-Ulrik S; Hein, Lars; Lundgren, Bettina

    2015-01-01

    OBJECTIVE:: Use of antibiotics in critically ill patients may increase the risk of invasive Candida infection. The objective of this study was to determine whether increased exposure to antibiotics is associated with increased prevalence of invasive Candida infection. DESIGN:: Substudy using data......, n = 604) or a "standard exposure" guided by current guidelines (n = 596). MEASUREMENTS AND MAIN RESULTS:: Seventy-four patients met the endpoint, "invasive Candida infection," 40 in the high exposure arm and 34 in standard exposure arm (relative risk = 1.2; 95% CI, 0.7-1.8; p = 0.52). Among medical...... patients in the high exposure arm, the use of ciprofloxacin and piperacillin/tazobactam was 51% and 75% higher than in the standard exposure arm; no difference in antibiotic exposure was observed between the randomized arms in surgical patients. Among medical intensive care patients, invasive Candida...

  4. Supporting Social and Cognitive Growth Among Disadvantaged Middle-Grades Students in TASC After-School Projects

    Christina A. Russell

    2006-09-01

    Full Text Available The field of after-school programming remains rife with unanswered questions. What constitutes quality in after-school programs? Are after-school opportunities valuable for participants regardless of their quality? Are differences in quality associated with differences in participant benefit? This sub-study of the longitudinal evaluation of The After-School Corporation (TASC looks at how after-school opportunities with varying features affect urban middle-grades (6-8 adolescents who live in impoverished circumstances. Supported by the William T. Grant Foundation, the study explores the associations between after-school project features and the social and cognitive outcomes of disadvantaged middle-grades participants in TASC programs. The study relies on data collected during the 2001-02 and 2002-03 school years in eight TASC projects serving middle-grades students.

  5. Cardiac troponin I degradation in serum of patients with hypertrophic obstructive cardiomyopathy undergoing percutaneous septal ablation

    Madsen, Lene H; Lund, Terje; Grieg, Zanina

    2009-01-01

    prior to initiation of PTSMA and up to 50 h following the procedure. Western blot analysis was performed with subsequent analysis of relative intensities of the bands as compared to the degradation of cTnI in STEMI patients from the ASSENT-2 troponin substudy. RESULTS: We demonstrate intact cTnI and 9...... degradation products [molecular weight (MW) 12.0-23.5 kDa]. The bands were comparable in MW to degradation fragments in STEMI. Their early rise in intensity, occurring within few minutes after the alcohol injection, emphasizes how susceptible troponin bands are to chemical/ischemic insults. Moreover, two...... additional bands were visible in the PTSMA population. CONCLUSION: This work describes the degradation products of troponin I in HOCM patients undergoing PTSMA. The detected bands appear fast and are similar to degradations following STEMI. This model contributes to our knowledge of the degradation patterns...

  6. Improved Detection of Common Variants Associated with Schizophrenia by Leveraging Pleiotropy with Cardiovascular-Disease Risk Factors

    Andreassen, Ole A; Djurovic, Srdjan; Thompson, Wesley K

    2013-01-01

    Several lines of evidence suggest that genome-wide association studies (GWASs) have the potential to explain more of the "missing heritability" of common complex phenotypes. However, reliable methods for identifying a larger proportion of SNPs are currently lacking. Here, we present a genetic......-pleiotropy-informed method for improving gene discovery with the use of GWAS summary-statistics data. We applied this methodology to identify additional loci associated with schizophrenia (SCZ), a highly heritable disorder with significant missing heritability. Epidemiological and clinical studies suggest comorbidity...... of the association with several CVD risk factors and a corresponding reduction in false discovery rate (FDR). We validate this "pleiotropic enrichment" by demonstrating increased replication rate across independent SCZ substudies. Applying the stratified FDR method, we identified 25 loci associated with SCZ...

  7. No effect on survival of home psychosocial intervention in a randomized study of Danish colorectal cancer patients

    Ross, Lone; Frederiksen, Kirsten; Boesen, Sidsel H

    2009-01-01

    social class and marital status. Likewise, no significant interactions were found between group and these covariates (all p>/=0.08). In the substudy of the possible effect of the intervention on immune parameters, there were no differences between the two groups with respect to lymphocyte proliferation...... or an intervention group. The intervention group received 10 home visits from a project nurse or a medical doctor during the first 2 years after discharge. The home visits aimed at providing emotional support and information. A subgroup of 55 patients provided blood samples 3, 12 and 24 months after discharge...... (all p>/=0.078) or natural killer cell activity (all p>/=0.33) and no consistent effect on the number of specific subsets of cells (phenotypes) during follow-up.Conclusion: The study failed to provide evidence that the psychosocial intervention provided as home visits significantly affected...

  8. Impact of time to return of spontaneous circulation on neuroprotective effect of targeted temperature management at 33 or 36 degrees in comatose survivors of out-of hospital cardiac arrest

    Kjaergaard, Jesper; Nielsen, Niklas; Winther-Jensen, Matilde

    2015-01-01

    AIM: Time to Return of Spontaneous Circulation (ROSC) has a plausible relation to severity of hypoxic injury before and during resuscitation in Out-of-Hospital Cardiac Arrest (OHCA), and has consistently been associated with adverse outcome. The effect of Targeted Temperature Management (TTM) may...... not be similar over the full spectrum of time to ROSC. This study investigated the possible beneficial effect of targeting 33°C over 36°C on the prognostic importance of time to ROSC. METHODS: In predefined sub-study of the TTM-trial (NEJM 2013) we investigated the relationship between time to ROSC, level of TTM...... and mortality and neurological outcome as assessed by the Cerebral Performance Category (CPC) scale and modified Rankin Scale (mRS) after 180 days. RESULTS: Prolonged time to ROSC was significantly associated with increased mortality with a hazard ratio (HR) of 1.02 per minute (95% CI 1.01-1.02). Level of TTM...

  9. Perceptions of Community HIV/STI Risk Among U.S Women Living in Areas with High Poverty and HIV Prevalence Rates.

    Blackstock, Oni J; Frew, Paula; Bota, Dorothy; Vo-Green, Linda; Parker, Kim; Franks, Julie; Hodder, Sally L; Justman, Jessica; Golin, Carol E; Haley, Danielle F; Kuo, Irene; Adimora, Adaora A; Rompalo, Anne; Soto-Torres, Lydia; Wang, Jing; Mannheimer, Sharon B

    2015-08-01

    Although studies have consistently demonstrated that women at high risk for HIV and non-HIV sexually transmitted infections (STIs) tend to underestimate their individual risk, little is known about how women at risk perceive their community's HIV/STI risk. We explored perceptions of community HIV/STI risk among U.S. women living in areas with high poverty and HIV prevalence rates as part of a qualitative substudy of the Women's HIV SeroIncidence Study. Semi-structured focus groups were conducted. Data were coded and analyzed using the constant comparative method. Participants expressed the perception that their communities were at elevated HIV/STI risk, mostly due to contextual and structural factors such as lack of access to health care and education. Findings suggest that HIV prevention messages that target U.S. women at high risk for HIV may be strengthened by addressing the high perceived community HIV/STI risk driven by structural factors.

  10. Estimating Effect Sizes and Expected Replication Probabilities from GWAS Summary Statistics

    Holland, Dominic; Wang, Yunpeng; Thompson, Wesley K

    2016-01-01

    Genome-wide Association Studies (GWAS) result in millions of summary statistics ("z-scores") for single nucleotide polymorphism (SNP) associations with phenotypes. These rich datasets afford deep insights into the nature and extent of genetic contributions to complex phenotypes such as psychiatric......-scores, as such knowledge would enhance causal SNP and gene discovery, help elucidate mechanistic pathways, and inform future study design. Here we present a parsimonious methodology for modeling effect sizes and replication probabilities, relying only on summary statistics from GWAS substudies, and a scheme allowing...... for estimating the degree of polygenicity of the phenotype and predicting the proportion of chip heritability explainable by genome-wide significant SNPs in future studies with larger sample sizes. We apply the model to recent GWAS of schizophrenia (N = 82,315) and putamen volume (N = 12,596), with approximately...

  11. No Neurocognitive Advantage for Immediate Antiretroviral Treatment in adults with greater than 500 CD4+ T Cell Counts

    Wright, Edwina J; Grund, Birgit; Robertson, Kevin R

    2018-01-01

    OBJECTIVE: To compare the effect of immediate versus deferred antiretroviral treatment (ART) on neuropsychological test performance in treatment-naive HIV-positive adults with >500 CD4+ cells/μL. DESIGN: Randomized trial. METHODS: The START parent study randomized participants to commence immediate...... versus deferred ART until CD4+ cells/μL. The START Neurology substudy used 8 neuropsychological tests, at baseline, months 4, 8, 12 and annually, to compare groups for changes in test performance. Test results were internally standardized to z-scores. The primary outcome was the average of the eight...... test z-scores (QNPZ-8). Mean changes in QNPZ-8 from baseline were compared by intent-to-treat using longitudinal mixed models. Changes from baseline to specific time points were compared using ANCOVA models. RESULTS: 592 participants had a median age of 34 years; median baseline CD4+ count of 629 cells...

  12. Design and Methodology of the Trial to Assess Chelation Therapy (TACT)

    Lamas, Gervasio A.; Goertz, Christine; Boineau, Robin; Mark, Daniel B.; Rozema, Theodore; Nahin, Richard L.; Drisko, Jeanne A.; Lee, Kerry L.

    2011-01-01

    The Trial to Assess Chelation Therapy (TACT) is an NIH-sponsored, randomized, double blind, placebo-controlled, 2×2 factorial clinical trial testing the benefits and risks of 40 infusions of a multi-component Na2EDTA-chelation solution compared with placebo, and of an oral, high-dose multivitamin and mineral supplement. TACT has randomized and will follow 1708 patients for an average of approximately 4 years. The primary endpoint is a composite of all cause mortality, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. A 900 patient substudy will examine quality of life outcomes. The trial is designed to have >85% power to detect a 25% relative reduction in the primary endpoint for each treatment factor. Enrollment began in September 2003 and completed in October 2010. PMID:22172430

  13. Clinical Aspects of Hypoxia-inducible Factors in Colorectal Cancer

    Havelund, Birgitte Mayland; Spindler, Karen-Lise Garm; Sørensen, Flemming Brandt

    2010-01-01

    Clinical Aspects of Hypoxia-inducible Factors in Colorectal Cancer  Birgitte Mayland Havelund1,4 MD, Karen-Lise Garm Spindler1,4 MD, PhD, Flemming Brandt Sørensen2,4 MD, DMSc, Ivan Brandslund3 MD, DMSc, Anders Jakobsen1,4 MD, DMSc.1Department of Oncology, 2Pathology and 3Biochemistry, Vejle...... Hospital, Vejle, Denmark4Institute of Regional Health Services Research, University of Southern Denmark, Odense DenmarkBackgroundPrognostic and predictive markers are needed for individualizing the treatment of colorectal cancer. Hypoxia-inducible factor 1α (HIF-1α) is a transcription-inducing factor which...... the predictive and prognostic value of HIF-1α in colorectal cancer.Materials and MethodsThe project is divided into 3 substudies:1. Biological and methodological aspects. The expression of HIF-1α measured by immunohistochemistry in paraffin embedded tissue is related to single nucleotide polymorphism (SNP...

  14. Effect of an Early Dose of Measles Vaccine on Morbidity Between 18 Weeks and 9 Months of Age: A Randomized, Controlled Trial in Guinea-Bissau

    Do, Vu An; Biering-Sorensen, Sofie; Fisker, Ane Bærent

    2017-01-01

    with a higher risk of the well-known adverse events of fever, rash, and convulsions within the first 14 days. From 15 days after randomization to age 9 months, early measles vaccination was associated with reductions in maternally reported diarrhea (hazard ratio [HR], 0.89; 95% confidence interval [CI],.82-. 97......Background: Children in Guinea-Bissau receive measles vaccine (MV) at 9 months of age, but studies have shown that an additional dose before 9 months of age might have beneficial nonspecific effects. Within a randomized trial designed to examine nonspecific effects of early MV receipt on mortality......, we conducted a substudy to investigate the effect of early MV receipt on morbidity. Methods: Children were randomly assigned at a ratio of 2: 1 to receive 2 doses of MVat 18 weeks and age 9 months (intervention group) or 1 dose of MV at age 9 months, in accordance with current practice (control group...

  15. Radon and lung cancer among New Jersey women

    Schoenberg, J.; Klotz, J.; Wilcox, H.; Nicholls, G.

    1990-01-01

    An epidemiologic study previously conducted in New Jersey women was extended to examine the association of lung cancer with radon exposure. The substudy included 433 cases and 402 controls who lived in a single index residence for 10+ years during the period 10--30 years prior to diagnosis or selection. Lung cancer risks showed a significant trend (p = 0.04) with increasing year-round living area radon concentrations (based on alpha track measurements), and a weaker (p = 0.09) trend with estimated cumulative radon exposure. The relative risk coefficient of 3.4% per working level month (WLM) was consistent with the range of 0.5--4%/WLM generally reported for underground miners. This paper results must be interpreted cautiously due to the small number of subjects with high radon exposures and the possibility of selection biases. Nevertheless, the study suggests that findings of radon-related lung cancer in miners can be applied to the residential setting

  16. Using the Platelet Function Analyzer-100 for monitoring aspirin therapy

    Poulsen, Tina Svenstrup; Mickley, Hans; Korsholm, Lars

    2007-01-01

    INTRODUCTION: The aim of the study was to evaluate the test characteristics of the Platelet Function Analyzer-100 (PFA-100) in patients treated with aspirin. METHODS AND RESULTS: The study consisted of two sub-studies. In study 1, 10 patients with ischemic heart disease (IHD) and 10 controls had...... platelet function assessed by optical platelet aggregation and the PFA-100 method in two 5-week periods. Patients with IHD were treated with aspirin 150 mg/day (first 5-week period), and 300 mg/day (second 5-week period), whereas the controls only received aspirin (150 mg/day) during the second 5-week...... period. From the results of study 1, we found that a cut-off value for the PFA-100 collagen/epinephrine cartridge PFA-100 method and optical platelet aggregation was found. Within...

  17. Pharmacists in a liberalised system - Results from a profession-wide survey in Iceland

    Almarsdóttir, Anna Birna; Björnsdóttir, Ingunn; Traulsen, Janine Morgall

    2002-01-01

    satisfaction was correlated with respondents' perception of the job's importance and responsibility, more so for community pharmacists than others. Overall job satisfaction was quite high and community pharmacists felt that their contact with customers was satisfactory. However, they were more dissatisfied...... with their work hours, importance of their work, and responsibility than other pharmacists. Conclusion - Community pharmacists have been affected more adversely by the legislative change than their colleagues in other work settings.......Background - The study reported here was part of a multi-study evaluation of new drug distribution legislation in Iceland. Objective - The objective of this sub-study was to compare the satisfaction of community pharmacists and pharmacists in other settings with regard to their job in general...

  18. The characteristics of women who use hypnotherapy for intrapartum pain management: Preliminary insights from a nationally-representative sample of Australian women.

    Steel, A; Frawley, J; Sibbritt, D; Broom, A; Adams, J

    2016-04-01

    This manuscript presents a preliminary examination of the characteristics of women who choose intrapartum hypnosis for pain management. Cross-sectional analysis of 2445 women (31-36 years) from a sub-study of the Australian Longitudinal Study on Women's Health (ALSWH), employing Fisher exact tests. Australia. Use of intrapartum hypnosis, or hypnobirthing, for pain management during labour and birth. Women using hypnobirthing were more likely to have consulted with an acupuncturist or naturopath, or attended yoga/meditation classes during pregnancy (phypnotherapy for intrapartum pain management less commonly identified as feeling safer knowing that an obstetrician is providing their care (phypnotherapy for intrapartum pain management. Copyright © 2016 Elsevier Ltd. All rights reserved.

  19. Exploring the affective domain in the teaching of mathematics

    Schmidt, Maria Christina Secher; Nissen, Stine Karen; Tonnesen, Pia Beck

    2015-01-01

    The paper presents the initial constructs of a study being carried out within the Danish public school (primary education) during the fall of 2015. It is based on a substudy conducted in connection with a study of the Early Mathematics Intervention Program for Marginal Groups in Denmark (TMTM i.e....... The methodology forms the basis for a qualitative approach toward gaining insight into the affective domain, which contributes to a field of research significantly dominated by quantitative approaches........e. Tidlig Matematikindsats Til Marginalgrupper). The 12-week intervention was implemented by 82 mathematics teachers in 41 schools in 31 different Danish municipalities. The presentation focuses on the development of a methodology aimed at capturing young students’ voices and views on mathematics...

  20. Subclinical Thyroid Dysfunction and Depressive Symptoms among Elderly

    Blum, Manuel R; Wijsman, Liselotte W; Virgini, Vanessa S

    2016-01-01

    adults aged 70-82 years with pre-existing cardiovascular disease or known cardiovascular risk factors, TSH and free T4 levels were measured at baseline and repeated after 6 months to define persistent thyroid function status. Main outcome measures were depressive symptoms, assessed with the Geriatric...... on the association of persistent subclinical thyroid dysfunction and depression, subclinical hypothyroidism was not associated with increased depressive symptoms among older adults at high cardiovascular risk. Persistent subclinical hyperthyroidism might be associated with increased depressive symptoms, which......BACKGROUND: Subclinical hypothyroidism has been associated with depressive symptoms in cross-sectional studies, but prospective data and data on subclinical hyperthyroidism are scarce. METHODS: In the Leiden sub-study of the Prospective Study of Pravastatin in the Elderly at Risk (PROSPER) among...

  1. Effect of recombinant erythropoietin on inflammatory markers in patients with affective disorders

    Vinberg, Maj; Weikop, Pia; Olsen, Niels Vidiendal

    2016-01-01

    Aim: This study investigated the effect of repeated infusions of recombinant human erythropoietin (EPO) on markers of inflammation in patients with affective disorders and whether any changes in inflammatory markers were associated with improvements on verbal memory. Methods: In total, 83 patients......). In both sub-studies, patients were randomised in a double-blind, parallel-group design to receive eight weekly intravenous infusions of EPO (Eprex; 40,000 IU/ml) or saline (0.9% NaCl). Plasma concentrations of interleukin 6 (IL-6), interleukin 18 (IL-18) and high sensitive c-reactive protein (hsCRP) were...... and change in verbal memory. Conclusions: Repeated EPO infusions had no effect on IL-6 and IL-18 levels but produced a modest increase in hsCRP levels in patients with TRD. Changes over time in inflammatory markers were not correlated with changes in cognition suggesting that modulation of the inflammatory...

  2. Effect of ACE insertion/deletion and 12 other polymorphisms on clinical outcomes and response to treatment in the life study

    Nordestgaard, Børge G; Kontula, Kimmo; Benn, Marianne

    2010-01-01

    OBJECTIVE: This pharmacogenetics substudy from the Losartan Intervention for Endpoint reduction in Hypertension study in patients with hypertension and left ventricular hypertrophy (LVH) treated with the angiotensin receptor blocker losartan versus the beta-blocker atenolol for 4.8 years tested...... whether the insertion/deletion (I/D) polymorphism of the angiotensin-converting enzyme (ACE) gene and 12 other previously well-characterized polymorphisms of hypertension susceptibility genes affected blood pressure reduction, heart rate reduction, cardiovascular events, and/or response to treatment....... These polymorphisms were chosen because they could affect blood pressure control or the pharmacological action of losartan or atenolol. METHODS: We genotyped 3503 patients, 1774 on losartan and 1729 on atenolol. RESULTS: ACE and the 12 other genotypes did not affect the reduction in systolic blood pressure, diastolic...

  3. Acid etching and plasma sterilization fail to improve osseointegration of grit blasted titanium implants

    Mortensen, Mikkel Saksø; Jakobsen, Stig Storgaard; Saksø, Henrik

    2012-01-01

    Interaction between implant surface and surrounding bone influences implant fixation. We attempted to improve the bone-implant interaction by 1) adding surface micro scale topography by acid etching, and 2) removing surface-adherent pro-inflammatory agents by plasma cleaning. Implant fixation...... was evaluated by implant osseointegration and biomechanical fixation.The study consisted of two paired animal sub-studies where 10 skeletally mature Labrador dogs were used. Grit blasted titanium alloy implants were inserted press fit in each proximal tibia. In the first study grit blasted implants were...... compared with acid etched grit blasted implants. In the second study grit blasted implants were compared with acid etched grit blasted implants that were further treated with plasma sterilization. Implant performance was evaluated by histomorphometrical investigation (tissue-to-implant contact, peri-implant...

  4. The Prevalence of Chagas Heart Disease in a Central Bolivian Community Endemic for Trypanosoma Cruzi

    Yager, Jessica E.; Lozano Beltran, Daniel F.; Torrico, Faustino; Gilman, Robert H.; Bern, Caryn

    2015-01-01

    Background Though the incidence of new Trypanosoma cruzi infections has decreased significantly in endemic regions in the Americas, medical professionals continue to encounter a high burden of resulting Chagas disease among infected adults. The current prevalence of Chagas heart disease in a community setting is not known; nor is it known how recent insecticide vector control measures may have impacted the progression of cardiac disease in an infected population. Objectives and Methods Nested within a community serosurvey in rural and periurban communities in central Bolivia, we performed a cross-sectional cardiac substudy to evaluate adults for historical, clinical, and electrocardiographic evidence of cardiac disease. All adults between the ages of 20 and 60 years old with T. cruzi infection and those with a clinical history, physical exam, or ECG consistent with cardiac abnormalities were also scheduled for echocardiography. Results and conclusions Of the 604 cardiac substudy participants with definitive serology results, 183 were seropositive for infection with T. cruzi (30.3%). Participants who were seropositive for T. cruzi infection were more likely to have conduction system defects (1.6% versus 0 for complete right bundle branch block and 10.4% versus 1.9% for any bundle branch block; p=0.008 and p<0.001, respectively). However, there was no statistically significant difference in the prevalence of bradycardia among seropositive versus seronegative participants. Echocardiogram findings were not consistent with a high burden of Chagas cardiomyopathy: valvulopathies were the most common abnormality, and few participants were found to have low ejection fraction or left ventricular dilatation. No participants had significant heart failure. Though almost one third of adults in the community were seropositive for T. cruzi infection, few had evidence of Chagas heart disease. PMID:26407509

  5. Validity of self reported male balding patterns in epidemiological studies

    Leavy Justine E

    2004-12-01

    Full Text Available Abstract Background Several studies have investigated the association between male pattern baldness and disease such as prostate cancer and cardiovascular disease. Limitations in the lack of standardized instruments to measure male pattern baldness have resulted in researchers measuring balding patterns in a variety of ways. This paper examines the accuracy and reliability of assessment of balding patterns by both trained observers and men themselves, using the Hamilton-Norwood classification system. Methods An observational study was carried out in Western Australia with 105 male volunteers aged between 30 and 70 years. Participants completed a short questionnaire and selected a picture that best represented their balding pattern. Two trained data collectors also independently assessed the participant's balding pattern using the same system and the men's self assessment was compared with the trained observer's assessment. In a substudy, observers assessed the balding pattern in a photo of the man aged 35 years while the man independently rated his balding at that age. Results Observers were very reliable in their assessment of balding pattern (85% exact agreement, κ = 0.83. Compared to trained observers, men were moderately accurate in their self-assessment of their balding status (48–55% exact agreement, κ = 0.39–0.46. For the substudy the exact agreement between the men and the observers was 67% and the agreement within balding groups was 87%. Conclusions We recommend that male balding patterns be assessed by trained personnel using the Hamilton-Norwood classification system. Where the use of trained personnel is not feasible, men's self assessment both currently and retrospectively has been shown to be adequate.

  6. Effect of rasagiline as adjunct therapy to levodopa on severity of OFF in Parkinson's disease.

    Stocchi, F; Rabey, J M

    2011-12-01

    The LARGO study demonstrated that rasagiline 1 mg/day as adjunct to levodopa significantly reduces OFF time to the same magnitude as adjunct entacapone. This substudy of LARGO aimed to assess the effect of rasagiline and entacapone on the motor symptoms of PD during the practically defined OFF state. LARGO was a randomized, double-blind, multicenter trial that assessed the efficacy and safety of rasagiline (1 mg/day), entacapone (200 mg with each levodopa dose), and placebo in 687 levodopa-treated PD patients with motor fluctuations. A substudy of LARGO measured UPDRS motor scores in the practically defined OFF state in 32 rasagiline, 36 entacapone, and 37 placebo patients. Treatment with rasagiline produced a significant improvement over placebo of 5.64 units in UPDRS motor OFF score (P = 0.013 vs. placebo). By contrast, the effect of adjunct entacapone was not significant (P = 0.14 vs. placebo). Whereas rasagiline also showed a trend in reducing the UPDRS-ADL OFF score (P = 0.058 vs. placebo), no such trend was noted for entacapone (P = 0.26 vs. placebo). Retrospective analysis, using the Bonferroni correction, of UPDRS motor subdomains further revealed that rasagiline, but not entacapone, significantly improved bradykinesia (P rasagiline 1 mg/day is effective in reducing the severity of motor symptoms in the OFF state. This suggests a continuous effect of rasagiline 1 mg/day throughout the day and night and is consistent with its extended duration of therapeutic action. © 2011 The Author(s). European Journal of Neurology © 2011 EFNS.

  7. Final report of MoReMO 2011-2012. Modelling resilience for maintenance and outage

    Gotcheva, N.; Macchi, L.; Oedewald, P.; Eitrheim, M.H.R.; Axelsson, C.; Reiman, T.; Pietikaeinen, E.

    2013-04-01

    The project Modelling Resilience for Maintenance and Outage (MoReMO) represents a two-year joint effort by VTT Technical Research Centre of Finland, Institute for Energy Technology (IFE, Norway) and Vattenfall (Sweden) to develop and test new approaches for safety management. The overall goal of the project was to present concepts on how resilience can be operationalized and built in a safety critical and socio-technical context. Furthermore, the project also aimed at providing guidance for other organizations that strive to develop and improve their safety performance in a business driven industry. We have applied four approaches in different case studies: Organisational Core Task modelling (OCT), Functional Resonance Analysis Method (FRAM), Efficiency Thoroughness Trade-Off (ETTO) analysis, and Work Practice and Culture Characterisation. During 2011 and 2012 the MoReMO project team has collected data through field observations, interviews, workshops, and document analysis on the work practices and adjustments in maintenance and outage in Nordic NPPs. The project consisted of two sub-studies, one focused on identifying and assessing adjustments and supporting resilient work practices in maintenance activities, while the other focused on handling performance trade-offs in maintenance and outage, as follows: A. Adjustments in maintenance work in Nordic nuclear power plants (VTT and Vattenfall). B. Handling performance trade-offs - the support of adaptive capacities (IFE and Vattenfall). The historical perspective of maintenance and outage management (Chapter 1.1) was provided by Vattenfall. Together, the two sub-studies have provided valuable insights for understanding the rationale behind work practices and adjustments, their effects on resilience, promoting flexibility and balancing between flexibility and reliability. (Author)

  8. Lung deflation and oxygen pulse in COPD: results from the NETT randomized trial.

    Come, Carolyn E; Divo, Miguel J; San José Estépar, Raúl; Sciurba, Frank C; Criner, Gerard J; Marchetti, Nathaniel; Scharf, Steven M; Mosenifar, Zab; Make, Barry J; Keller, Cesar A; Minai, Omar A; Martinez, Fernando J; Han, MeiLan K; Reilly, John J; Celli, Bartolome R; Washko, George R

    2012-01-01

    In COPD patients, hyperinflation impairs cardiac function. We examined whether lung deflation improves oxygen pulse, a surrogate marker of stroke volume. In 129 NETT patients with cardiopulmonary exercise testing (CPET) and arterial blood gases (ABG substudy), hyperinflation was assessed with residual volume to total lung capacity ratio (RV/TLC), and cardiac function with oxygen pulse (O(2) pulse=VO(2)/HR) at baseline and 6 months. Medical and surgical patients were divided into "deflators" and "non-deflators" based on change in RV/TLC from baseline (∆RV/TLC). We defined deflation as the ∆RV/TLC experienced by 75% of surgical patients. We examined changes in O(2) pulse at peak and similar (iso-work) exercise. Findings were validated in 718 patients who underwent CPET without ABGs. In the ABG substudy, surgical and medical deflators improved their RV/TLC and peak O(2) pulse (median ∆RV/TLC -18.0% vs. -9.3%, p=0.0003; median ∆O(2) pulse 13.6% vs. 1.8%, p=0.12). Surgical deflators also improved iso-work O(2) pulse (0.53 mL/beat, p=0.04 at 20 W). In the validation cohort, surgical deflators experienced a greater improvement in peak O(2) pulse than medical deflators (mean 18.9% vs. 1.1%). In surgical deflators improvements in O(2) pulse at rest and during unloaded pedaling (0.32 mL/beat, pdeflators were 88% more likely than non-deflators to have an improvement in O(2) pulse (OR 1.88, 95% CI 1.30-2.72, p=0.0008). In COPD, decreased hyperinflation through lung volume reduction is associated with improved O(2) pulse. Copyright © 2011 Elsevier Ltd. All rights reserved.

  9. Associations of hair cortisol concentration with self-reported measures of stress and mental health-related factors in a pooled database of diverse community samples.

    Wells, Samantha; Tremblay, Paul F; Flynn, Andrea; Russell, Evan; Kennedy, James; Rehm, Jürgen; Van Uum, Stan; Koren, Gideon; Graham, Kathryn

    2014-07-01

    A pooled database from diverse community samples was used to examine the associations of hair cortisol concentration (HCC) with self-reported stress and stress-linked mental health measures, including depression, anxiety, alcohol and drug use, disability and experiences with aggression. As part of innovative research using a mobile laboratory to study community mental health, data were pooled from five sub-studies: a random sample of the general population (n = 70), people who had received treatment for a mental health and/or substance use problem (n = 78), family members of people treated for mental health and/or substance use problems (n = 49), community volunteers who sometimes felt sad or blue or thought they drank too much (n = 83) and young adults in intimate partner relationships (n = 44). All participants completed a computerized questionnaire including standard measures of perceived stress, chronic stress, depression, anxiety, hazardous drinking, tobacco use, prescription drug use, illicit drug use, disability and intimate partner aggression. HCC was significantly associated with use of antidepressants, hazardous drinking, smoking and disability after adjusting for sub-study and potential confounders (sex, body-mass index, use of glucocorticoids and hair dyed). In addition, preliminary analyses suggest a significant curvilinear relationship between HCC and perceived stress; specifically, HCC increased with higher perceived stress but decreased at the highest level of stress. Overall, HCC was associated with mental health-related variables mainly reflecting substance use or experiencing a disability. The relationship between HCC and self-reported stress is unclear and needs further research.

  10. Hydroxychloroquine effectiveness in reducing symptoms of hand osteoarthritis (HERO): study protocol for a randomized controlled trial

    2013-01-01

    Background Osteoarthritis (OA) is the most common type of arthritis, causing significant joint pain and disability. It is already a major cause of healthcare expenditure and its incidence will further increase with the ageing population. Current treatments for OA have major limitations and new analgesic treatments are needed. Synovitis is prevalent in OA and is associated with pain. Hydroxychloroquine is used in routine practice for treating synovitis in inflammatory arthritides, such as rheumatoid arthritis. We propose that treating patients with symptomatic hand OA with hydroxychloroquine will be a practical and safe treatment to reduce synovitis and pain. Methods/design HERO is an investigator-initiated, multicentre, randomized, double-blind, placebo-controlled trial. A total of 252 subjects with symptomatic hand OA will be recruited across primary and secondary care sites in the UK and randomized on a 1:1 basis to active treatment or placebo for 12 months. Daily medication dose will range from 200 to 400 mg according to ideal body weight. The primary endpoint is change in average hand pain during the previous two weeks (measured on a numerical rating scale (NRS)) between baseline and six months. Secondary endpoints include other self-reported pain, function and quality-of-life measures and radiographic structural change at 12 months. A health economics analysis will also be performed. An ultrasound substudy will be conducted to examine baseline levels of synovitis. Linear and logistic regression will be used to compare changes between groups using univariable and multivariable modelling analyses. All analyses will be conducted on an intention-to-treat basis. Discussion The HERO trial is designed to examine whether hydroxychloroquine is an effective analgesic treatment for OA and whether it provides any long-term structural benefit. The ultrasound substudy will address whether baseline synovitis is a predictor of therapeutic response. This will potentially

  11. Move the Neighbourhood: Study design of a community-based participatory public open space intervention in a Danish deprived neighbourhood to promote active living

    Charlotte Skau Pawlowski

    2017-05-01

    Full Text Available Abstract Background A limited amount of research has examined the effect of changing public open spaces on active living. This paper will present the study protocol of a community-based intervention study co-designed in an interdisciplinary collaboration with community members to develop urban installations highly tailored to promote active living among children (10–13-years-old and seniors (>60-years-old in a deprived neighbourhood in Copenhagen. Methods The study builds on a quasi-experimental study design with two sub-studies: 1 a children study and 2 a senior study. The interventions will be developed, designed and implemented in collaboration with local children and seniors, respectively, using different co-design tools and methods. We will evaluate the effect of the interventions on children’s and senior’s use of the new-built urban installations using accelerometers in combination with GPS as well as systematic observation using the System for Observing Play and Recreation in Communities (SOPARC. A process evaluation with focus groups consisting of the various stakeholders in the two sub-studies will be used to gain knowledge of the intervention processes. Discussion The paper presents new approaches in the field of public open space interventions through interdisciplinary collaboration, participatory co-design approach and combination of measurements. Using both effect and process evaluations the study will provide unique insights in the role and importance of the interdisciplinary collaboration, participatory processes, and tailoring changes in public open space to local needs and wishes. These results can be used to guide urban renewal projects in deprived neighbourhoods in the future. Trial registration Retrospectively registered with study ID ISRCTN50036837 . Date of registration: 16 December 2016.

  12. Final report of MoReMO 2011-2012. Modelling resilience for maintenance and outage

    Gotcheva, N.; Macchi, L.; Oedewald, P. [Technical Research Centre of Finland (VTT), Espoo (Finland); Eitrheim, M.H.R. [Institute for Energy Technology (IFE) (Norway); Axelsson, C.; Reiman, T.; Pietikaeinen, E. [Ringhals AB (NPP), Vattenfall AB (Sweden)

    2013-04-15

    The project Modelling Resilience for Maintenance and Outage (MoReMO) represents a two-year joint effort by VTT Technical Research Centre of Finland, Institute for Energy Technology (IFE, Norway) and Vattenfall (Sweden) to develop and test new approaches for safety management. The overall goal of the project was to present concepts on how resilience can be operationalized and built in a safety critical and socio-technical context. Furthermore, the project also aimed at providing guidance for other organizations that strive to develop and improve their safety performance in a business driven industry. We have applied four approaches in different case studies: Organisational Core Task modelling (OCT), Functional Resonance Analysis Method (FRAM), Efficiency Thoroughness Trade-Off (ETTO) analysis, and Work Practice and Culture Characterisation. During 2011 and 2012 the MoReMO project team has collected data through field observations, interviews, workshops, and document analysis on the work practices and adjustments in maintenance and outage in Nordic NPPs. The project consisted of two sub-studies, one focused on identifying and assessing adjustments and supporting resilient work practices in maintenance activities, while the other focused on handling performance trade-offs in maintenance and outage, as follows: A. Adjustments in maintenance work in Nordic nuclear power plants (VTT and Vattenfall). B. Handling performance trade-offs - the support of adaptive capacities (IFE and Vattenfall). The historical perspective of maintenance and outage management (Chapter 1.1) was provided by Vattenfall. Together, the two sub-studies have provided valuable insights for understanding the rationale behind work practices and adjustments, their effects on resilience, promoting flexibility and balancing between flexibility and reliability. (Author)

  13. Advisory Committee Societal and Environmental Aspects Test Wind Farm Oosterbierum. Adviescommissie Maatschappelijke en Milieu-Aspecten Proefwindpark Oosterbierum (NL); Eindrapportage van de onderzoeksresultaten

    1992-12-01

    An overview is given of the results of research on the title wind farm. The test wind turbine array consists of 3 rows of six 300 kW horizontal axis turbines, with an axis height of 35 meters, and a rotor diameter of 30 meters. The purpose of the test wind farm was to gain experience with regard to planning aspects, environmental aspects (flora and fauna) and societal acceptation and perception. The title committee (AMMA, abbreviated in Dutch) was installed in 1982 with the purpose to formulate the problems and research proposals, to advise research bureaus and institutes on the sub-studies, and to evaluate the results of the surveys and studies and to assess the possibility of using wind energy within the electric power supply in the Netherlands. All seven sub-studies, started by AMMA, are described briefly: a study on the effects of the wind farm on birds, a study on the effect of the wind farm on traffic, attracted by the wind turbine array, a study on the impact of the wind turbines on the agricultural management, an analysis of the effects on the landscape, a study on the visual perception of the wind turbines, a social-psychological study or the societal acceptation of wind power plants, and a study on the effects of surrounding objects on the wind availability for wind farms. If wind energy must contribute to the Dutch power supply as planned, many energy efficient and profitable wind turbines have to be installed in the Netherlands, excluding the areas which are important for birds or recreational areas. 4 figs., 28 refs.

  14. Association between depressive symptoms, CD4 count and HIV viral suppression among HIV-HCV co-infected people.

    Aibibula, Wusiman; Cox, Joseph; Hamelin, Anne-Marie; Moodie, Erica E M; Anema, Aranka; Klein, Marina B; Brassard, Paul

    2018-05-01

    Depressive symptoms are associated with poor HIV viral control and immune recovery among people living with HIV. However, no prior studies assessed this association exclusively among people co-infected with HIV-hepatitis C virus (HCV). While people with HIV only and those with HIV-HCV co-infection share many characteristics, co-infected people may become more susceptible to the effects of depressive symptoms on health outcomes. We assessed this association exclusively among people co-infected with HIV-HCV in Canada using data from the Food Security & HIV-HCV Sub-Study (FS Sub-Study) of the Canadian Co-Infection Cohort (CCC). Stabilized inverse probability weighted marginal structural model was used to account for potential time-varying confounders. A total of 725 participants were enrolled between 2012 and 2015. At baseline, 52% of participants reported depressive symptoms, 75% had undetectable HIV viral load, and median CD4 count was 466 (IQR 300-665). People experiencing depressive symptoms had 1.32 times (95% CI: 1.07, 1.63) the risk of having detectable HIV viral load, but had comparable CD4 count to people who did not experience depressive symptoms (fold change of CD4 = 0.96, 95% CI: 0.91, 1.03). Presence of depressive symptoms is a risk factor for incomplete short-term HIV viral suppression among people co-infected with HIV-HCV. Therefore, depressive symptoms screening and related counseling may improve HIV related health outcomes and reduce HIV transmission.

  15. Short-term changes in arterial inflammation predict long-term changes in atherosclerosis progression

    Joseph, Philip [Massachusetts General Hospital and Harvard Medical School, Cardiology Division and Cardiac MR PET CT Program, Boston, MA (United States); McMaster University, Population Health Research Institute, Department of Medicine, and Department of Radiology, Hamilton, ON (Canada); Ishai, Amorina; Tawakol, Ahmed [Massachusetts General Hospital and Harvard Medical School, Cardiology Division and Cardiac MR PET CT Program, Boston, MA (United States); Mani, Venkatesh [Icahn School of Medicine at Mount Sinai School of Medicine, Translational and Molecular Imaging Institute and Department of Radiology, New York, NY (United States); Kallend, David [The Medicines Company, Parsippany, NJ (United States); Rudd, James H.F. [University of Cambridge, Division of Cardiovascular Medicine, Cambridge (United Kingdom); Fayad, Zahi A. [Icahn School of Medicine at Mount Sinai School of Medicine, Translational and Molecular Imaging Institute and Department of Radiology, New York, NY (United States); Icahn School of Medicine at Mount Sinai School of Medicine, Hess CSM Building Floor TMII, Rm S1-104, Translational and Molecular Imaging Institute and Department of Radiology, New York, NY (United States)

    2017-01-15

    It remains unclear whether changes in arterial wall inflammation are associated with subsequent changes in the rate of structural progression of atherosclerosis. In this sub-study of the dal-PLAQUE clinical trial, multi-modal imaging was performed using 18-fludeoxyglucose (FDG) positron emission tomography (PET, at 0 and 6 months) and magnetic resonance imaging (MRI, at 0 and 24 months). The primary objective was to determine whether increasing FDG uptake at 6 months predicted atherosclerosis progression on MRI at 2 years. Arterial inflammation was measured by the carotid FDG target-to-background ratio (TBR), and atherosclerotic plaque progression was defined as the percentage change in carotid mean wall area (MWA) and mean wall thickness (MWT) on MRI between baseline and 24 months. A total of 42 participants were included in this sub-study. The mean age of the population was 62.5 years, and 12 (28.6 %) were women. In participants with (vs. without) any increase in arterial inflammation over 6 months, the long-term changes in both MWT (% change MWT: 17.49 % vs. 1.74 %, p = 0.038) and MWA (% change MWA: 25.50 % vs. 3.59 %, p = 0.027) were significantly greater. Results remained significant after adjusting for clinical and biochemical covariates. Individuals with no increase in arterial inflammation over 6 months had no significant structural progression of atherosclerosis over 24 months as measured by MWT (p = 0.616) or MWA (p = 0.373). Short-term changes in arterial inflammation are associated with long-term structural atherosclerosis progression. These data support the concept that therapies that reduce arterial inflammation may attenuate or halt progression of atherosclerosis. (orig.)

  16. Move the Neighbourhood: Study design of a community-based participatory public open space intervention in a Danish deprived neighbourhood to promote active living.

    Pawlowski, Charlotte Skau; Winge, Laura; Carroll, Sidse; Schmidt, Tanja; Wagner, Anne Margrethe; Nørtoft, Kamilla Pernille Johansen; Lamm, Bettina; Kural, René; Schipperijn, Jasper; Troelsen, Jens

    2017-05-19

    A limited amount of research has examined the effect of changing public open spaces on active living. This paper will present the study protocol of a community-based intervention study co-designed in an interdisciplinary collaboration with community members to develop urban installations highly tailored to promote active living among children (10-13-years-old) and seniors (>60-years-old) in a deprived neighbourhood in Copenhagen. The study builds on a quasi-experimental study design with two sub-studies: 1) a children study and 2) a senior study. The interventions will be developed, designed and implemented in collaboration with local children and seniors, respectively, using different co-design tools and methods. We will evaluate the effect of the interventions on children's and senior's use of the new-built urban installations using accelerometers in combination with GPS as well as systematic observation using the System for Observing Play and Recreation in Communities (SOPARC). A process evaluation with focus groups consisting of the various stakeholders in the two sub-studies will be used to gain knowledge of the intervention processes. The paper presents new approaches in the field of public open space interventions through interdisciplinary collaboration, participatory co-design approach and combination of measurements. Using both effect and process evaluations the study will provide unique insights in the role and importance of the interdisciplinary collaboration, participatory processes, and tailoring changes in public open space to local needs and wishes. These results can be used to guide urban renewal projects in deprived neighbourhoods in the future. Retrospectively registered with study ID ISRCTN50036837 . Date of registration: 16 December 2016.

  17. Prophylactic Use of Haloperidol and Changes in Glucose Levels in Hospitalized Older Patients.

    van Keulen, Kris; Knol, Wilma; Schrijver, Edmée J M; van Marum, Rob J; van Strien, Astrid M; Nanayakkara, Prabath W B

    2018-02-01

    Treatment with antipsychotic drugs has been associated with glucose dysregulation in older outpatients, especially in the early stage of therapy. The underlying mechanism is, however, unclear. The aim of this study was to investigate changes in glucose levels during haloperidol use compared with the use of placebo among older hospitalized patients. This substudy was part of a larger multicenter, randomized, double blind, placebo-controlled clinical trial among hospitalized patients aged 70 years and older who had an increased risk of in-hospital delirium. Patients who were admitted to the Jeroen Bosch Hospital in 's-Hertogenbosch between June 2014 and February 2015 were invited to participate in the study. Participating patients were randomized for treatment and given 1 mg of haloperidol or a placebo twice daily for a maximum of 7 consecutive days (14 doses). Exclusion criteria for this substudy were the use of corticosteroids and changes in diabetes medication. Random blood samples to determine glucose levels were collected before day 1 and on day 6 of the study. Student independent sample t test was used to determine differences in glucose changes between both groups. Twenty-nine patients were included (haloperidol, n = 14; placebo, n = 15). The mean glucose level for placebo users was 139.3 mg/dL (SD, 50.1) on day 1 and 140.8 mg/dL (SD, 45.7) on day 6, and the mean glucose level for haloperidol users was 139.9 mg/dL (SD, 71.0) on day 1 and 150.2 mg/dL (SD, 39.1) on day 6. The difference was not statistically significant (P = 0.685). Short-term prophylactic use of haloperidol was not associated with changes in glucose levels in older hospitalized patients compared with those given a placebo in this small study.

  18. The Action to Control Cardiovascular Risk in Diabetes Memory in Diabetes Study (ACCORD-MIND): rationale, design, and methods.

    Williamson, Jeff D; Miller, Michael E; Bryan, R Nick; Lazar, Ronald M; Coker, Laura H; Johnson, Janice; Cukierman, Tali; Horowitz, Karen R; Murray, Anne; Launer, Lenore J

    2007-06-18

    Type 2 diabetes mellitus and cognitive impairment are 2 of the most common chronic conditions found in persons aged > or = 60 years. Clinical studies have shown a greater prevalence of global cognitive impairment, incidence of cognitive decline, and incidence of Alzheimer disease in patients with type 2 diabetes. To date, there have been no randomized trials of the effects of long-term glycemic control on cognitive function and structural brain changes in patients with type 2 diabetes. The primary aim of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Memory in Diabetes Study (ACCORD-MIND) is to test whether there is a difference in the rate of cognitive decline and structural brain change in patients with diabetes treated with standard-care guidelines compared with those treated with intensive-care guidelines. This comparison will be made in a subsample of 2,977 patients with diabetes participating in the ongoing ACCORD trial, a clinical trial sponsored by the National Heart, Lung, and Blood Institute (NHLBI) with support from the National Institute on Aging (NIA). Data from this ACCORD substudy on the possible beneficial or adverse effects of intensive treatment on cognitive function will be obtained from a 30-minute test battery, administered at baseline and 20-month and 40-month visits. In addition, full-brain magnetic resonance imaging will be performed on 630 participants at baseline and at 40 months to assess the relation between the ACCORD treatments and structural brain changes. The general aim of ACCORD-MIND is to determine whether the intensive treatment of diabetes, a major risk factor for Alzheimer disease and vascular dementia, can reduce the early decline in cognitive function that could later evolve into more cognitively disabling conditions. This report presents the design, rationale, and methods of the ACCORD-MIND substudy.

  19. Update on the MRI Core of the Alzheimer's Disease Neuroimaging Initiative

    Jack, Clifford R; Bernstein, Matt A; Borowski, Bret J; Gunter, Jeffrey L; Fox, Nick C; Thompson, Paul M; Schuff, Norbert; Krueger, Gunnar; Killiany, Ronald J; DeCarli, Charles S; Dale, Anders M; Weiner, Michael W

    2010-01-01

    Functions of the ADNI MRI core fall into three categories: (1) those of the central MRI core lab at Mayo Clinic, Rochester, Minnesota, needed to generate high quality MRI data in all subjects at each time point; (2) those of the funded ADNI MRI core imaging analysis groups responsible for analyzing the MRI data, and (3) the joint function of the entire MRI core in designing and problem solving MR image acquisition, pre-processing and analyses methods. The primary objective of ADNI was and continues to be improving methods for clinical trials in Alzheimer's disease. Our approach to the present (“ADNI-GO”) and future (“ADNI-2”, if funded) MRI protocol will be to maintain MRI methodological consistency in previously enrolled “ADNI-1” subjects who are followed longitudinally in ADNI-GO and ADNI-2. We will modernize and expand the MRI protocol for all newly enrolled ADNI-GO and ADNI-2 subjects. All newly enrolled subjects will be scanned at 3T with a core set of three sequence types: 3D T1-weighted volume, FLAIR, and a long TE gradient echo volumetric acquisition for micro hemorrhage detection. In addition to this core ADNI-GO and ADNI-2 protocol, we will perform vendor specific pilot sub-studies of arterial spin labeling perfusion, resting state functional connectivity and diffusion tensor imaging. One each of these sequences will be added to the core protocol on systems from each MRI vendor. These experimental sub-studies are designed to demonstrate the feasibility of acquiring useful data in a multi-center (but single vendor) setting for these three emerging MRI applications. PMID:20451869

  20. Bone mineral density in partially recovered early onset anorexic patients - a follow-up investigation

    Schneider Peter

    2010-07-01

    Full Text Available Abstract Background and aims There still is a lack of prospective studies on bone mineral development in patients with a history of early onset Anorexia nervosa (AN. Therefore we assessed associations between bone mass accrual and clinical outcomes in a former clinical sample. In addition to an expected influence of regular physical activity and hormone replacement therapy, we explored correlations with nutritionally dependent hormones. Methods 3-9 years (mean 5.2 ± 1.7 after hospital discharge, we re-investigated 52 female subjects with a history of early onset AN. By means of a standardized approach, we evaluated the general outcome of AN. Moreover, bone mineral content (BMC and bone mineral density (BMD as well as lean and fat mass were measured by dual-energy x-ray absorptiometry (DXA. In a substudy, we measured the serum concentrations of leptin and insulin-like growth factor-I (IGF-I. Results The general outcome of anorexia nervosa was good in 50% of the subjects (BMI ≥ 17.5 kg/m2, resumption of menses. Clinical improvement was correlated with BMC and BMD accrual (χ2 = 5.62/χ2 = 6.65, p = 0.06 / p = 0.036. The duration of amenorrhea had a negative correlation with BMD (r = -.362; p th percentile. IGF-I serum concentrations corresponded to the general outcome of AN. By contrast, leptin serum concentrations showed great variability. They correlated with BMC and current body composition parameters. Conclusions Our results from the main study indicate a certain adaptability of bone mineral accrual which is dependent on a speedy and ongoing recovery. While leptin levels in the substudy tended to respond immediately to current nutritional status, IGF-I serum concentrations corresponded to the individual's age and general outcome of AN.

  1. Plasma zinc, vitamin B(12) and α-tocopherol are positively and plasma γ-tocopherol is negatively associated with Hb concentration in early pregnancy in north-west Bangladesh.

    Shamim, Abu Ahmed; Kabir, Alamgir; Merrill, Rebecca D; Ali, Hasmot; Rashid, Mahbubur; Schulze, Kerry; Labrique, Alain; West, Keith P; Christian, Parul

    2013-08-01

    The objective of the current analysis was to explore the association of multiple micronutrients with Hb concentration among pregnant women in a South Asian setting, a topic that has not been adequately explored. Sociodemographic, anthropometric and micronutrient status (plasma ferritin, transferrin receptor, retinol, a- and g-tocopherol, folate, vitamin B12, Zn) and Hb concentration were assessed at early pregnancy. The biochemical sub-study was nested within a double-blind, placebo-controlled, community-based vitamin A and b-carotene supplementation trial in rural north-western Bangladesh (JiVitA). All assessments were conducted before trial supplementation was initiated. A systematic sample of 285 women was selected from those enrolled in the biochemical sub-study. Seventeen per cent of women were mildly anaemic; moderate and severe anaemia was uncommon (2.1 %). a-Tocopherol, vitamin B12 and Zn deficiencies were common (43.5%, 19.7% and 14.7%, respectively); however, vitamin A, folate and Fe deficiencies were comparatively rare (7.4%, 2.8% and ,1%,respectively). Plasma Zn, vitamin B12 and a-tocopherol were positively associated and plasma g-tocopherol was negatively associated with Hb (P < 0.05) after adjustment for gestational age, inflammation status, season and nutritional status measured by mid-upper arm circumference. Among pregnant women in rural Bangladesh with minimal Fe deficiency, plasma Zn, vitamin B12, and a- and g-tocopherol concentrations were associated with Hb concentration. Appreciating the influence on Hb of micronutrients in addition to those with known associations with anaemia, such as Fe, folate, and vitamin A, is important when addressing anaemia in similar settings.

  2. Brain Damage and Motor Cortex Impairment in Chronic Obstructive Pulmonary Disease: Implication of Nonrapid Eye Movement Sleep Desaturation.

    Alexandre, Francois; Heraud, Nelly; Sanchez, Anthony M J; Tremey, Emilie; Oliver, Nicolas; Guerin, Philippe; Varray, Alain

    2016-02-01

    Nonrapid eye movement (NREM) sleep desaturation may cause neuronal damage due to the withdrawal of cerebrovascular reactivity. The current study (1) assessed the prevalence of NREM sleep desaturation in nonhypoxemic patients with chronic obstructive pulmonary disease (COPD) and (2) compared a biological marker of cerebral lesion and neuromuscular function in patients with and without NREM sleep desaturation. One hundred fifteen patients with COPD (Global Initiative for Chronic Obstructive Lung Disease [GOLD] grades 2 and 3), resting PaO2 of 60-80 mmHg, aged between 40 and 80 y, and without sleep apnea (apnea-hypopnea index sleep recordings. In addition, twenty-nine patients (substudy) were assessed i) for brain impairment by serum S100B (biological marker of cerebral lesion), and ii) for neuromuscular function via motor cortex activation and excitability and maximal voluntary quadriceps strength measurement. A total of 51.3% patients (n = 59) had NREM sleep desaturation (NREMDes). Serum S100B was higher in the NREMDes patients of the substudy (n = 14): 45.1 [Q1: 37.7, Q3: 62.8] versus 32.9 [Q1: 25.7, Q3: 39.5] pg.ml(-1) (P = 0.028). Motor cortex activation and excitability were lower in NREMDes patients (both P = 0.03), but muscle strength was comparable between groups (P = 0.58). Over half the nonhypoxemic COPD patients exhibited NREM sleep desaturation associated with higher values of the cerebral lesion biomarker and lower neural drive reaching the quadriceps during maximal voluntary contraction. The lack of muscle strength differences between groups suggests a compensatory mechanism(s). Altogether, the results are consistent with an involvement of NREM sleep desaturation in COPD brain impairment. The study was registered at www.clinicaltrials.gov as NCT01679782. © 2016 Associated Professional Sleep Societies, LLC.

  3. Studying complex interventions: reflections from the FEMHealth project on evaluating fee exemption policies in West Africa and Morocco.

    Marchal, Bruno; Van Belle, Sara; De Brouwere, Vincent; Witter, Sophie

    2013-11-08

    The importance of complexity in health care policy-making and interventions, as well as research and evaluation is now widely acknowledged, but conceptual confusion reigns and few applications of complexity concepts in research design have been published. Taking user fee exemption policies as an entry point, we explore the methodological consequences of 'complexity' for health policy research and evaluation. We first discuss the difference between simple, complicated and complex and introduce key concepts of complex adaptive systems theory. We then apply these to fee exemption policies. We describe how the FEMHealth research project attempts to address the challenges of complexity in its evaluation of fee exemption policies for maternal care. We present how the development of a programme theory for fee exemption policies was used to structure the overall design. This allowed for structured discussions on the hypotheses held by the researchers and helped to structure, integrate and monitor the sub-studies. We then show how the choice of data collection methods and tools for each sub-study was informed by the overall design. Applying key concepts from complexity theory proved useful in broadening our view on fee exemption policies and in developing the overall research design. However, we encountered a number of challenges, including maintaining adaptiveness of the design during the evaluation, and ensuring cohesion in the disciplinary diversity of the research teams. Whether the programme theory can fulfil its claimed potential to help making sense of the findings is yet to be tested. Experience from other studies allows for some moderate optimism. However, the biggest challenge complexity throws at health system researchers may be to deal with the unknown unknowns and the consequence that complex issues can only be understood in retrospect. From a complexity theory point of view, only plausible explanations can be developed, not predictive theories. Yet here

  4. The effect of recombinant human growth hormone with or without rosiglitazone on hepatic fat content in HIV-1-infected individuals: a randomized clinical trial.

    Kotler, Donald P; He, Qing; Engelson, Ellen S; Albu, Jeanine B; Glesby, Marshall J

    2016-01-01

    Hepatic fat is related to insulin resistance (IR) and visceral adipose tissue (VAT) in HIV+ and uninfected individuals. Growth hormone (GH) reduces VAT but increases IR. We evaluated the effects of recombinant human GH (rhGH) and rosiglitazone (Rosi) on hepatic fat in a substudy of a randomized controlled trial. HIV+ subjects with abdominal obesity and IR (QUICKI≤0.33) were randomized to rhGH 3 mg daily, Rosi 4 mg twice daily, the combination or double placebo. Hepatic fat was measured by magnetic resonance spectroscopy, visceral fat by MRI and IR by frequently sampled intravenous glucose tolerance tests at baseline and week 12. 31 subjects were studied at both time points. Significant correlations between hepatic fat and VAT (r=0.41; P=0.02) and QUICKI (r=0.39; P<0.05) were seen at baseline. IR rose with rhGH but not Rosi. When rhGH treatment groups were combined, hepatic fat expressed as percentage change decreased significantly (P<0.05) but did not change in Rosi (P=0.71). There were no correlations between changes in hepatic fat and VAT (P=0.4) or QUICKI (P=0.6). In a substudy of 21 subjects, a trend was noticed between changes in hepatic fat and serum insulin-like growth factor-1 (IGF-1; P=0.09). Hepatic fat correlates significantly with both VAT and IR, but changes in hepatic fat do not correlate with changes in VAT and glucose metabolism. Hepatic fat content is reduced by rhGH but Rosi has no effect. These results suggest an independent effect of GH or IGF-1 on hepatic fat. The study was registered at Clinicaltrials.gov (NCT00130286).

  5. The effect of recombinant human growth hormone with or without rosiglitazone on hepatic fat content in HIV-1 infected individuals; a randomized clinical trial

    Kotler, Donald P; He, Qing; Engelson, Ellen S; Albu, Jeanine B; Glesby, Marshall J

    2016-01-01

    Background Hepatic fat is related to insulin resistance (IR) and visceral adipose tissue (VAT) in HIV+ and uninfected individuals. Growth hormone (GH) reduces VAT but increases IR. We evaluated the effects of recombinant human GH (rhGH) and rosiglitazone (Rosi) on hepatic fat in a substudy of a randomized controlled trial. Methods HIV+ subjects with abdominal obesity and IR (QUICKI ≤ 0.33) were randomized to rhGH 3 mg daily, Rosi 4 mg twice daily, the combination, or double placebo. Hepatic fat was measured by magnetic resonance spectroscopy (MRS), visceral fat by MRI, and IR by frequently sampled IV glucose tolerance tests at baseline and week 12. Results 31 subjects were studied at both time points. Significant correlations between hepatic fat and VAT (r = 0.41, p=0.02) and QUICKI (r = 0.39, p<0.05) were seen at baseline. Insulin resistance rose with rhGH but not Rosi. When rhGH treatment groups were combined, hepatic fat expressed as percent change decreased significantly (p<0.05) but did not change in Rosi (p=0.71). There were no correlations between changes in hepatic fat and VAT (p=0.4) or QUICKI (p=0.6). In a substudy of 21 subjects, a trend was noticed between changes in hepatic fat and serum IGF-1 (p=0.09). Conclusions Hepatic fat correlates significantly with both VAT and IR, but changes in hepatic fat do not correlate with changes in VAT and glucose metabolism. Hepatic fat content is reduced by rhGH but Rosi has no effect. These results suggest an independent effect of growth hormone or IGF-1 on hepatic fat. The study was registered at Clinicaltrials.gov (NCT00130286). PMID:25536669

  6. Sphericity index and E-point-to-septal-separation (EPSS) to diagnose dilated cardiomyopathy in Doberman Pinschers.

    Holler, P J; Wess, G

    2014-01-01

    E-point-to-septal-separation (EPSS) and the sphericity index (SI) are echocardiographic parameters that are recommended in the ESVC-DCM guidelines. However, SI cutoff values to diagnose dilated cardiomyopathy (DCM) have never been evaluated. To establish reference ranges, calculate cutoff values, and assess the clinical value of SI and EPSS to diagnose DCM in Doberman Pinschers. One hundred seventy-nine client-owned Doberman Pinschers. Three groups were formed in this prospective longitudinal study according to established Holter and echocardiographic criteria using the Simpson method of disk (SMOD): control group (97 dogs), DCM with echocardiographic changes (75 dogs) and "last normal" group (n = 7), which included dogs that developed DCM within 1.5 years, but were still normal at this time point. In a substudy, dogs with early DCM based upon SMOD values above the reference range but still normal M-Mode measurements were selected, to evaluate if EPSS or SI were abnormal using the established cutoff values. ROC-curve analysis determined 6.5 mm for EPSS (sensitivity 100%; specificity 99.0%) as optimal cutoff values to diagnose DCM. Both parameters were significantly different between the control group and the DCM group (P < 0.001), but were not abnormal in the "last normal" group. In the substudy, EPSS was abnormal in 13/13 dogs and SI in 2/13 dogs. E-point-to-septal-separation is a valuable additional parameter for the diagnosis of DCM, which can enhance diagnostic capabilities of M-Mode and which performs similar as well as SMOD. Copyright © 2013 by the American College of Veterinary Internal Medicine.

  7. Metabolic Tumor Volume as a Prognostic Imaging-Based Biomarker for Head-and-Neck Cancer: Pilot Results From Radiation Therapy Oncology Group Protocol 0522

    Schwartz, David L., E-mail: david.schwartz@utsw.edu [Department of Radiation Oncology, University of Texas Southwestern School of Medicine, Dallas, Texas (United States); Harris, Jonathan [Radiation Therapy Oncology Group Statistical Center, Philadelphia, Pennsylvania (United States); Yao, Min [Department of Radiation Oncology, Case Western Reserve University School of Medicine, Cleveland, Ohio (United States); Rosenthal, David I. [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Opanowski, Adam; Levering, Anthony [American College of Radiology Imaging Network, Philadelphia, Pennsylvania (United States); Ang, K. Kian [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Trotti, Andy M. [Department of Radiation Oncology, Moffitt Cancer Center, Tampa, Florida (United States); Garden, Adam S. [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Jones, Christopher U. [Sutter Medical Group, Sacramento, California (United States); Harari, Paul [Department of Human Oncology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin (United States); Foote, Robert [Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota (United States); Holland, John [Department of Radiation Medicine, Oregon Health & Science University, Portland, Oregon (United States); Zhang, Qiang [Radiation Therapy Oncology Group Statistical Center, Philadelphia, Pennsylvania (United States); Le, Quynh-Thu [Department of Radiation Oncology, Stanford University School of Medicine, Palo Alto, California (United States)

    2015-03-15

    Purpose: To evaluate candidate fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) imaging biomarkers for head-and-neck chemoradiotherapy outcomes in the cooperative group trial setting. Methods and Materials: Radiation Therapy Oncology Group (RTOG) protocol 0522 patients consenting to a secondary FDG-PET/CT substudy were serially imaged at baseline and 8 weeks after radiation. Maximum standardized uptake value (SUVmax), SUV peak (mean SUV within a 1-cm sphere centered on SUVmax), and metabolic tumor volume (MTV) using 40% of SUVmax as threshold were obtained from primary tumor and involved nodes. Results: Of 940 patients entered onto RTOG 0522, 74 were analyzable for this substudy. Neither high baseline SUVmax nor SUVpeak from primary or nodal disease were associated with poor treatment outcomes. However, primary tumor MTV above the cohort median was associated with worse local-regional control (hazard ratio 4.01, 95% confidence interval 1.28-12.52, P=.02) and progression-free survival (hazard ratio 2.34, 95% confidence interval 1.02-5.37, P=.05). Although MTV and T stage seemed to correlate (mean MTV 6.4, 13.2, and 26.8 for T2, T3, and T4 tumors, respectively), MTV remained a strong independent prognostic factor for progression-free survival in bivariate analysis that included T stage. Primary MTV remained prognostic in p16-associated oropharyngeal cancer cases, although sample size was limited. Conclusion: High baseline primary tumor MTV was associated with worse treatment outcomes in this limited patient subset of RTOG 0522. Additional confirmatory work will be required to validate primary tumor MTV as a prognostic imaging biomarker for patient stratification in future trials.

  8. Changes in renal function associated with oral emtricitabine/tenofovir disoproxil fumarate use for HIV pre-exposure prophylaxis.

    Solomon, Marc M; Lama, Javier R; Glidden, David V; Mulligan, Kathleen; McMahan, Vanessa; Liu, Albert Y; Guanira, Juan Vicente; Veloso, Valdilea G; Mayer, Kenneth H; Chariyalertsak, Suwat; Schechter, Mauro; Bekker, Linda-Gail; Kallás, Esper Georges; Burns, David N; Grant, Robert M

    2014-03-27

    Tenofovir disoproxil fumarate (TDF) pre-exposure prophylaxis decreases sexual acquisition of HIV infection. We sought to evaluate the renal safety of TDF in HIV-uninfected persons. The Iniciativa Profilaxis Pre-Exposición (iPrEx) study randomly assigned 2499 HIV-seronegative men and transgender women who have sex with men (MSM) to receive oral daily TDF coformulated with emtricitabine (FTC/TDF) or placebo. Serum creatinine and phosphorus during randomized treatment and after discontinuation were measured, and creatinine clearance (CrCl) was estimated by the Cockcroft-Gault equation. Indicators of proximal renal tubulopathy (fractional excretion of phosphorus and uric acid, urine protein, and glucose) were measured in a substudy. There was a small but statistically significant decrease in CrCl from baseline in the active arm, compared to placebo, which was first observed at week 4 (mean change: -2.4 vs. -1.1 ml/min; P=0.02), persisted through the last on-treatment visit (mean change: +0.3 vs. +1.8 ml/min; P=0.02), and resolved after stopping pre-exposure prophylaxis (mean change: -0.1 vs. 0.0 ml/min; P=0.83). The effect was confirmed when stratifying by drug detection. The effect of FTC/TDF on CrCl did not vary by race, age, or history of hypertension. There was no difference in serum phosphate trends between the treatment arms. In the substudy, two participants receiving placebo had indicators of tubulopathy. In HIV-seronegative MSM, randomization to FTC/TDF was associated with a very mild nonprogressive decrease in CrCl that was reversible and managed with routine serum creatinine monitoring.

  9. Schizophrenia causes significant burden to patients' and caregivers' lives.

    Szkultecka-Dębek, Monika; Miernik, Katarzyna; Stelmachowski, Jarosław; Jakovljević, Miro; Jukić, Vlado; Aadamsoo, Kaire; Janno, Sven; Bitter, István; Tolna, Judit; Jarema, Marek; Jankovic, Slobodan; Pecenak, Jan; Vavrusova, Livia; Tavčar, Rok; Walczak, Jacek; Talbot, Darren; Augustyńska, Joanna

    2016-06-01

    Schizophrenia is a serious public health problem and is ranked among the most disabling diseases in the world. The sub-study presented here was part of a larger project to characterize the burden of schizophrenia on healthcare systems and on individuals living with the disease in Central and Eastern Europe (CEE). This sub-study aimed to assess and analyze the impact of schizophrenia on many aspects of the lives of patients and caregivers. Psychiatrists from selected centers in seven Central and Eastern European countries were asked to complete a questionnaire in order to collect information about the disease history, characteristics, treatment protocols and resources used for each randomly selected patient. All data were statistically analyzed and compared between countries. Data from 961 patients with schizophrenia (mean age 40.7 years, 45.1% female) were included in the analysis. The mean number of days spent in hospital per patient per year across all seven countries was 25.3 days. Hospitalization occurred on average once per year, with psychiatrist visits 9.4 times per year. Of the patients in the study, 61% were single, 12% divorced and 22% married or cohabiting. Almost 84% were living with relatives or a partner; only 17% lived alone and, on average, 25% of patients received support from social workers. Relatives provided care for approximately 60% of patients and 4% of them had to stop working in order to do so. Twenty-nine percent of the patients were unemployed, and 56% received a disability pension or were retired, with only 19% in full-time employment or education. Schizophrenia has a significant effect on the lives of patients and caregivers and impacts their social integration.

  10. Effects of Evolocumab on Vitamin E and Steroid Hormone Levels: Results From the 52-Week, Phase 3, Double-Blind, Randomized, Placebo-Controlled DESCARTES Study.

    Blom, Dirk J; Djedjos, C Stephen; Monsalvo, Maria Laura; Bridges, Ian; Wasserman, Scott M; Scott, Rob; Roth, Eli

    2015-09-25

    Vitamin E transport and steroidogenesis are closely associated with low-density lipoproteins (LDLs) metabolism, and evolocumab can lower LDL cholesterol (LDL-C) to low levels. To determine the effects of evolocumab on vitamin E and steroid hormone levels. After titration of background lipid-lowering therapy per cardiovascular risk, 901 patients with an LDL-C ≥2.0 mmol/L were randomized to 52 weeks of monthly, subcutaneous evolocumab, or placebo. Vitamin E, cortisol, adrenocorticotropic hormone, and gonadal hormones were analyzed at baseline and week 52. In a substudy (n=100), vitamin E levels were also measured in serum, LDL, high-density lipoprotein, and red blood cell membranes at baseline and week 52. Absolute vitamin E decreased in evolocumab-treated patients from baseline to week 52 by 16% but increased by 19% when normalized for cholesterol. In the substudy, vitamin E level changes from baseline to week 52 mirrored the changes in the lipid fraction, and red blood cell membrane vitamin E levels did not change. Cortisol in evolocumab-treated patients increased slightly from baseline to week 52, but adrenocorticotropic hormone and the cortisol:adrenocorticotropic hormone ratio did not change. No patient had a cortisol:adrenocorticotropic hormone ratio <3.0 (nmol/pmol). Among evolocumab-treated patients, gonadal hormones did not change from baseline to week 52. Vitamin E and steroid changes were consistent across subgroups by minimum postbaseline LDL-C <0.4 and <0.6 mmol/L. As expected, vitamin E levels changed similarly to lipids among patients treated for 52 weeks with evolocumab. No adverse effects were observed in steroid or gonadal hormones, even at very low LDL-C levels. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01516879. © 2015 American Heart Association, Inc.

  11. The PiGeOn project: protocol for a longitudinal study examining psychosocial, behavioural and ethical issues and outcomes in cancer tumour genomic profiling.

    Best, Megan; Newson, Ainsley J; Meiser, Bettina; Juraskova, Ilona; Goldstein, David; Tucker, Kathy; Ballinger, Mandy L; Hess, Dominique; Schlub, Timothy E; Biesecker, Barbara; Vines, Richard; Vines, Kate; Thomas, David; Young, Mary-Anne; Savard, Jacqueline; Jacobs, Chris; Butow, Phyllis

    2018-04-05

    Genomic sequencing in cancer (both tumour and germline), and development of therapies targeted to tumour genetic status, hold great promise for improvement of patient outcomes. However, the imminent introduction of genomics into clinical practice calls for better understanding of how patients value, experience, and cope with this novel technology and its often complex results. Here we describe a protocol for a novel mixed-methods, prospective study (PiGeOn) that aims to examine patients' psychosocial, cognitive, affective and behavioural responses to tumour genomic profiling and to integrate a parallel critical ethical analysis of returning results. This is a cohort sub-study of a parent tumour genomic profiling programme enrolling patients with advanced cancer. One thousand patients will be recruited for the parent study in Sydney, Australia from 2016 to 2019. They will be asked to complete surveys at baseline, three, and five months. Primary outcomes are: knowledge, preferences, attitudes and values. A purposively sampled subset of patients will be asked to participate in three semi-structured interviews (at each time point) to provide deeper data interpretation. Relevant ethical themes will be critically analysed to iteratively develop or refine normative ethical concepts or frameworks currently used in the return of genetic information. This will be the first Australian study to collect longitudinal data on cancer patients' experience of tumour genomic profiling. Findings will be used to inform ongoing ethical debates on issues such as how to effectively obtain informed consent for genomic profiling return results, distinguish between research and clinical practice and manage patient expectations. The combination of quantitative and qualitative methods will provide comprehensive and critical data on how patients cope with 'actionable' and 'non-actionable' results. This information is needed to ensure that when tumour genomic profiling becomes part of routine

  12. Calcium channel blockers and breast cancer incidence: An updated systematic review and meta-analysis of the evidence.

    Wright, Cameron M; Moorin, Rachael E; Chowdhury, Enayet K; Stricker, Bruno H; Reid, Christopher M; Saunders, Christobel M; Hughes, Jeffery D

    2017-10-01

    Controversy exists regarding the potential association between taking calcium channel blockers (CCBs) and the development of breast cancer. As a positive association would have important public health implications due to the widespread use of CCBs, this study aimed to incorporate new evidence to determine whether an association is likely to exist. We searched MEDLINE, EMBASE and the Cochrane Library to 28 June 2016 for relevant literature. References and citing articles were checked and authors contacted as necessary. Two authors independently selected articles and extracted data. Twenty-nine studies were reviewed; 26 were non-randomised studies (NRS). Meta-analysis of study data where adjustment for 'confounding by indication' was judged to be present suggests that an association, if any, is likely to be modest in magnitude (pooled odds/risk ratio 1.09 (95% confidence interval (CI) 1.03-1.15, I 2 =0%, 8 sub-studies; pooled hazard ratio 0.99 (95% CI 0.94-1.03, I 2 =35%, 9 sub-studies)). There are credible study data showing an increased relative risk with long-term use of CCBs, but the results of our meta-analysis and of meta-regression of log relative risk against minimum follow-up time are mixed. The current summative evidence does not support a clear association between taking CCBs and developing breast cancer. However, uncertainty remains, especially for long-term use and any association might not be uniform between different populations and/or breast cancer sub-types. We thus recommend further NRS in settings where CCB use is highly prevalent and population-based cancer, prescription and health-registries exist, to resolve this continuing uncertainty. PROSPERO, CRD42015026712. Copyright © 2017 Elsevier Ltd. All rights reserved.

  13. Short-term changes in arterial inflammation predict long-term changes in atherosclerosis progression

    Joseph, Philip; Ishai, Amorina; Tawakol, Ahmed; Mani, Venkatesh; Kallend, David; Rudd, James H.F.; Fayad, Zahi A.

    2017-01-01

    It remains unclear whether changes in arterial wall inflammation are associated with subsequent changes in the rate of structural progression of atherosclerosis. In this sub-study of the dal-PLAQUE clinical trial, multi-modal imaging was performed using 18-fludeoxyglucose (FDG) positron emission tomography (PET, at 0 and 6 months) and magnetic resonance imaging (MRI, at 0 and 24 months). The primary objective was to determine whether increasing FDG uptake at 6 months predicted atherosclerosis progression on MRI at 2 years. Arterial inflammation was measured by the carotid FDG target-to-background ratio (TBR), and atherosclerotic plaque progression was defined as the percentage change in carotid mean wall area (MWA) and mean wall thickness (MWT) on MRI between baseline and 24 months. A total of 42 participants were included in this sub-study. The mean age of the population was 62.5 years, and 12 (28.6 %) were women. In participants with (vs. without) any increase in arterial inflammation over 6 months, the long-term changes in both MWT (% change MWT: 17.49 % vs. 1.74 %, p = 0.038) and MWA (% change MWA: 25.50 % vs. 3.59 %, p = 0.027) were significantly greater. Results remained significant after adjusting for clinical and biochemical covariates. Individuals with no increase in arterial inflammation over 6 months had no significant structural progression of atherosclerosis over 24 months as measured by MWT (p = 0.616) or MWA (p = 0.373). Short-term changes in arterial inflammation are associated with long-term structural atherosclerosis progression. These data support the concept that therapies that reduce arterial inflammation may attenuate or halt progression of atherosclerosis. (orig.)

  14. Midpregnancy Doppler ultrasound of the uterine artery in metformin- versus placebo-treated PCOS women: a randomized trial.

    Stridsklev, Solhild; Carlsen, Sven M; Salvesen, Øyvind; Clemens, Ilka; Vanky, Eszter

    2014-03-01

    Metformin is used to reduce pregnancy complications in women with polycystic ovary syndrome (PCOS), although it is not approved for this indication and solid evidence is lacking. Midpregnancy Doppler ultrasound is one of the best methods for prediction of adverse pregnancy outcome. The objectives of the study were to investigate the following: 1) whether metformin treatment influenced the midpregnancy pulsatility index (PI) of the uterine artery; 2) whether metabolic or endocrine factors affect the PI of the uterine artery of PCOS women; and 3) whether PI predicted adverse pregnancy outcome in PCOS woman. This is a substudy of a randomized, placebo-controlled, double-blind, multicenter study conducted at 11 secondary care centers. We randomly assigned 273 pregnancies to receive metformin or placebo, from the first trimester of pregnancy to delivery. In the present substudy, 231 pregnancies are included, ie, those who completed the ultrasound examinations. Midpregnancy PI in the uterine artery related to metformin use, androgen levels, an oral glucose tolerance test, and insulin levels was measured. We found no difference in the PI between the metformin and placebo groups. In multivariate analyses, fasting serum glucose of the first and second trimester correlated positively to the midpregnancy PI. Only in univariate analyses a weak correlation between androstenedione and PI was seen. Metformin treatment did not affect uterine artery blood flow, measured by PI. High fasting blood glucose correlated inversely to uterine artery blood flow. The midpregnancy PI correlated positively to preeclampsia, hypertension, and gestational diabetes mellitus in PCOS pregnancies. Androgen levels correlated only to PI in univariate analyses.

  15. Diabetes self-management education: acceptability of using trained lay educators.

    Mandalia, P K; Stone, M A; Davies, M J; Khunti, K; Carey, M E

    2014-11-01

    The use of lay people to deliver education programmes for people with chronic conditions is a potential method of addressing healthcare staff capacity and increasing the cost efficiency of delivering education. This qualitative substudy is embedded within an equivalence trial (2008-2011 including development stage). In the qualitative substudy, we aimed to elicit the views of key stakeholders (patients, educators) about using lay people to deliver education to people recently diagnosed with type 2 diabetes, alongside a healthcare professional educator with an equal role. In this way, we sought to explore perceptions about acceptability and also contribute to understanding the reasons underlying positive or negative quantitative findings from main trial. We conducted 27 telephone interviews with a purposive sample of patients, lay educators and healthcare professional educators involved in the main trial. Thematic analysis of transcribed data was underpinned by the constant comparative approach and structured using Framework methodology. Overall, the data suggested that the use of lay educators was acceptable to educators and patients. Perceived difference in knowledge levels between lay and healthcare professional educators did not appear to have an impact on perceived acceptability or the effectiveness of the education received. Additional themes explored were related to peer status of educators and feasibility. Some concerns were raised about lay educators with diabetes, transferring personal issues and about the impact of healthcare professional time taken up by mentoring and supporting lay educators. Positive perceptions about the use of lay educators support the positive quantitative findings from the main trial. Acceptability is an important consideration in relation to implementation of the model of delivery studied. Concerns raised within the interviews should be considered in the design of training for lay educators. ISRCTN 99350009. Published by the BMJ

  16. Evaluation of the specificity of radionuclide myocardial imaging for detecting CAD

    Liu Xiujie

    1992-01-01

    In order to evaluate the specificity of radionuclide myocardial perfusion imaging for detecting coronary artery disease (CAD), 50 patients with normal coronary arteriography and radionuclide myocardial perfusion scintigraphy were analysed. The results from 201 T1 (20 cases) and 99m Tc-MIBI (30 cases) studies showed that out of 33 patients with no organic cardiovascular disease, 29 had normal myocardial imaging, and the specificity of radionuclide myocardial imaging for detecting CAD was 87.8%. 4 normal young women had false positive myocardial imaging. Out of 17 patients with cardiovascular disease and normal coronary arteriography, 15 patients had abnormal myocardial imaging. The final clinical diagnoses of these 15 patients were: 4 patients with hypertrophic cardiomyopathy, 3 with old myocardial infarction, 2 with myocarditis, 3 with small coronary vessel disease, 1 with congestive cardiomyopathy, and 2 with other cardiac disorder. The points of differentiation between CAD and other cardiovascular disease using radionuclide techniques were discussed

  17. Electrical storm: case series and review of management.

    Srivatsa, Uma N; Ebrahimi, Ramin; El-Bialy, Adel; Wachsner, Robin Y

    2003-09-01

    Electrical storm is defined as a recurrent episode of hemodynamically destabilizing ventricular tachyarrhythmia that usually requires electrical cardioversion or defibrillation. We describe three cases presenting with electrical storm under differing circumstances: (1) a 57-year-old man with ST-elevation myocardial infarction within 1 week of a posterior circulation stroke who developed refractory sustained ventricular tachycardia 10 days after an acute myocardial infarction; (2) a 65-year-old man who developed polymorphic ventricular tachycardia and ventricular fibrillation following dobutamine echocardiography; and (3) a 20-year-old woman who developed intractable ventricular fibrillation following an overdose of a weight-reduction pill. The management of electrical storm is discussed, and evolving literature supporting the routine use of intravenous amiodarone and beta-blockers in place of intravenous lidocaine is critically examined.

  18. The effects of marriage partners' socio-economic positions on the risk of divorce in Finland

    Marika Jalovaara

    2007-01-01

    Full Text Available The high and increasing incidence of divorce, with the various consequences for adults and children, has aroused interest among social scientists in understanding the contributory factors. Prominent economic and psychosocial theories suggest that the husband’s social and economic resources tend to stabilize a marriage, whereas the wife’s economic success tends to destabilize it (the gendered hypothesis. Register-based follow-up data from Statistics Finland on first marriages in Finland that were intact at the end of 1990 and divorces in 199193 (n=21,309, and Poisson regression were used to analyze the impact of the socio-economic positions of the spouses on the risk of divorce. This thesis consists of three articles published in international refereed journals, and a summary article. The aim of sub-study I was to disentangle the influences of various aspects of the spouses’ socio-economic positions on divorce risk and to reveal the causal pathways through which each socio-economic factor was related to it. Sub-study II investigated the joint effects of both spouses’ socio-economic positions. Finally, sub-study III explored the possibility that the effect of spouses’ socio-economic positions on divorce risk might vary according to the duration of the marriage.  When examined individually, divorce risk was inversely associated with socio-economic status for all its various indicators (i.e. each spouse’s education, occupational class, economic activity, and income, as well as housing tenure and housing density except the wife’s income. All of these factors had an independent effect. The independent effect was weak for both spouses’ occupational rankings and housing density, however, and it was positive for the wife’s income. The divorce risk for couples with both partners at the lowest educational level was lower than expected on the basis of its overall inverse association with each spouse’s education. Employed and

  19. Towards global benchmarking of food environments and policies to reduce obesity and diet-related non-communicable diseases: design and methods for nation-wide surveys.

    Vandevijvere, Stefanie; Swinburn, Boyd

    2014-05-15

    Unhealthy diets are heavily driven by unhealthy food environments. The International Network for Food and Obesity/non-communicable diseases (NCDs) Research, Monitoring and Action Support (INFORMAS) has been established to reduce obesity, NCDs and their related inequalities globally. This paper describes the design and methods of the first-ever, comprehensive national survey on the healthiness of food environments and the public and private sector policies influencing them, as a first step towards global monitoring of food environments and policies. A package of 11 substudies has been identified: (1) food composition, labelling and promotion on food packages; (2) food prices, shelf space and placement of foods in different outlets (mainly supermarkets); (3) food provision in schools/early childhood education (ECE) services and outdoor food promotion around schools/ECE services; (4) density of and proximity to food outlets in communities; food promotion to children via (5) television, (6) magazines, (7) sport club sponsorships, and (8) internet and social media; (9) analysis of the impact of trade and investment agreements on food environments; (10) government policies and actions; and (11) private sector actions and practices. For the substudies on food prices, provision, promotion and retail, 'environmental equity' indicators have been developed to check progress towards reducing diet-related health inequalities. Indicators for these modules will be assessed by tertiles of area deprivation index or school deciles. International 'best practice benchmarks' will be identified, against which to compare progress of countries on improving the healthiness of their food environments and policies. This research is highly original due to the very 'upstream' approach being taken and its direct policy relevance. The detailed protocols will be offered to and adapted for countries of varying size and income in order to establish INFORMAS globally as a new monitoring initiative

  20. Dose-Related Target Occupancy and Effects on Circuitry, Behavior, and Neuroplasticity of the Glycine Transporter-1 Inhibitor PF-03463275 in Healthy and Schizophrenia Subjects.

    D'Souza, Deepak Cyril; Carson, Richard E; Driesen, Naomi; Johannesen, Jason; Ranganathan, Mohini; Krystal, John H

    2018-01-31

    Glycine transporter-1 (GlyT1) inhibitors may ameliorate cognitive impairments associated with schizophrenia. The dose-related occupancy and target engagement of the GlyT1 inhibitor PF-03463275 were studied to inform optimal dose selection for a clinical trial for cognitive impairments associated with schizophrenia. In substudy 1, the effects of PF-03463275 (10, 20, and 40 mg twice a day) on occupancy of GlyT1 were tested using positron emission tomography and 18 F-MK-6577, and visual long-term potentiation (LTP) in schizophrenia patients (SZs) and healthy control subjects. Furthermore, the capacity of PF-03463275 to attenuate ketamine-induced disruption of working memory-related activation of a "working memory" circuit was tested only in healthy control subjects using functional magnetic resonance imaging. Subsequently, the effects of PF-03463275 (60 mg twice a day) on occupancy of GlyT1 and long-term potentiation were examined only in SZs (substudy 2). PF-03463275 at 10, 20, 40, and 60 mg twice a day produced ∼44%, 61%, 76%, and 83% GlyT1 occupancy, respectively, in SZs with higher ligand binding to GlyT1 in subcortical versus cortical regions. PF-03463275 did not attenuate any ketamine-induced effects but did improve working memory accuracy in healthy control subjects. PF-03463275 increased long-term potentiation only in SZs with peak effects at 40 mg twice a day (∼75% GlyT1 occupancy) and with a profile suggestive of an inverted U dose response. PF-03463275 was well-tolerated. The dose-related GlyT1 occupancy of PF-03463275 is linear. While PF-03463275 did not show evidence of facilitating N-methyl-D-aspartate receptor function in the ketamine assay, it enhanced neuroplasticity in SZs. These findings provide support for a clinical trial to test the ability of PF-03463275 to enhance cognitive remediation toward addressing cognitive impairments associated with schizophrenia. Published by Elsevier Inc.

  1. RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID−TIA): study protocol for a pilot randomised controlled trial

    2013-01-01

    Background People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist – that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist? Methods/Design This is a pilot randomised controlled trial with a sub-study of accuracy of primary care physician diagnosis of TIA. In the pilot trial, we aim to recruit 100 patients from 30 general practices (including out-of-hours general practice centres) and 1 emergency department whom the primary care physician diagnoses with TIA or minor stroke and randomly assign them to usual care (that is, initiation of aspirin and referral to a TIA clinic) or usual care plus additional early initiation of secondary prevention drugs (a blood-pressure lowering protocol, simvastatin 40 mg and dipyridamole 200 mg m/r bd). The primary outcome of the main study will be the number of strokes at 90 days. The diagnostic accuracy sub-study will include these 100 patients and an additional 70 patients in whom the primary care physician thinks the diagnosis of TIA is possible, rather than probable. For the pilot trial, we will report recruitment rate, follow-up rate, a preliminary estimate of the primary event rate and occurrence of any adverse events. For the diagnostic study, we will calculate sensitivity and specificity of primary care physician diagnosis using the final

  2. RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID-TIA): study protocol for a pilot randomised controlled trial.

    Edwards, Duncan; Fletcher, Kate; Deller, Rachel; McManus, Richard; Lasserson, Daniel; Giles, Matthew; Sims, Don; Norrie, John; McGuire, Graham; Cohn, Simon; Whittle, Fiona; Hobbs, Vikki; Weir, Christopher; Mant, Jonathan

    2013-07-02

    People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist--that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist? This is a pilot randomised controlled trial with a sub-study of accuracy of primary care physician diagnosis of TIA. In the pilot trial, we aim to recruit 100 patients from 30 general practices (including out-of-hours general practice centres) and 1 emergency department whom the primary care physician diagnoses with TIA or minor stroke and randomly assign them to usual care (that is, initiation of aspirin and referral to a TIA clinic) or usual care plus additional early initiation of secondary prevention drugs (a blood-pressure lowering protocol, simvastatin 40 mg and dipyridamole 200 mg m/r bd). The primary outcome of the main study will be the number of strokes at 90 days. The diagnostic accuracy sub-study will include these 100 patients and an additional 70 patients in whom the primary care physician thinks the diagnosis of TIA is possible, rather than probable. For the pilot trial, we will report recruitment rate, follow-up rate, a preliminary estimate of the primary event rate and occurrence of any adverse events. For the diagnostic study, we will calculate sensitivity and specificity of primary care physician diagnosis using the final TIA clinic diagnosis as the

  3. Study design of PANGAEA 2.0, a non-interventional study on RRMS patients to be switched to fingolimod.

    Ziemssen, Tjalf; Kern, Raimar; Cornelissen, Christian

    2016-08-08

    The therapeutic options for patients with Multiple Sclerosis (MS) have steadily increased due to the approval of new substances that now supplement traditional first-line agents, demanding a paradigm shift in the assessment of disease activity and treatment response in clinical routine. Here, we report the study design of PANGAEA 2.0 (Post-Authorization Non-interventional GermAn treatment benefit study of GilEnyA in MS patients), a non-interventional study in patients with relapsing-remitting MS (RRMS) identify patients with disease activity and monitor their disease course after treatment switch to fingolimod (Gilenya®), an oral medication approved for patients with highly active RRMS. In the first phase of the PANGAEA 2.0 study the disease activity status of patients receiving a disease-modifying therapy (DMT) is evaluated in order to identify patients at risk of disease progression. This evaluation is based on outcome parameters for both clinical disease activity and magnetic resonance imaging (MRI), and subclinical measures, describing disease activity from the physician's and the patient's perspective. In the second phase of the study, 1500 RRMS patients identified as being non-responders and switched to fingolimod (oral, 0.5 mg/daily) are followed-up for 3 years. Data on relapse activity, disability progression, MRI lesions, and brain volume loss will be assessed in accordance to 'no evidence of disease activity-4' (NEDA-4). The modified Rio score, currently validated for the evaluation of treatment response to interferons, will be used to evaluate the treatment response to fingolimod. The MS management software MSDS3D will guide physicians through the complex processes of diagnosis and treatment. A sub-study further analyzes the benefits of a standardized quantitative evaluation of routine MRI scans by a central reading facility. PANGAEA 2.0 is being conducted between June 2015 and December 2019 in 350 neurological practices and centers in Germany

  4. Pharmacogenetics of efficacy and safety of HCV treatment in HCV-HIV coinfected patients: significant associations with IL28B and SOCS3 gene variants.

    Francesc Vidal

    Full Text Available This was a safety and efficacy pharmacogenetic study of a previously performed randomized trial which compared the effectiveness of treatment of hepatitis C virus infection with pegylated interferon alpha (pegIFNα 2a vs. 2b, both with ribavirin, for 48 weeks, in HCV-HIV coinfected patients.The study groups were made of 99 patients (efficacy pharmacogenetic substudy and of 114 patients (safety pharmacogenetic substudy. Polymorphisms in the following candidate genes IL28B, IL6, IL10, TNFα, IFNγ, CCL5, MxA, OAS1, SOCS3, CTLA4 and ITPA were assessed. Genotyping was carried out using Sequenom iPLEX-Gold, a single-base extension polymerase chain reaction. Efficacy end-points assessed were: rapid, early and sustained virological response (RVR, EVR and SVR, respectively. Safety end-points assessed were: anemia, neutropenia, thrombocytopenia, flu-like syndrome, gastrointestinal disturbances and depression. Chi square test, Student's T test, Mann-Whitney U test and logistic regression were used for statistic analyses.As efficacy is concerned, IL28B and CTLA4 gene polymorphisms were associated with RVR (p<0.05 for both comparisons. Nevertheless, only polymorphism in the IL28B gene was associated with SVR (p = 0.004. In the multivariate analysis, the only gene independently associated with SVR was IL28B (OR 2.61, 95%CI 1.2-5.6, p = 0.01. With respect to safety, there were no significant associations between flu-like syndrome or depression and the genetic variants studied. Gastrointestinal disturbances were associated with ITPA gene polymorphism (p = 0.04. Anemia was associated with OAS1 and CTLA4 gene polymorphisms (p = 0.049 and p = 0.045, respectively, neutropenia and thromobocytopenia were associated with SOCS3 gene polymorphism (p = 0.02 and p = 0.002, respectively. In the multivariate analysis, the associations of the SOCS3 gene polymorphism with neutropenia (OR 0.26, 95%CI 0.09-0.75, p = 0.01 and thrombocytopenia (OR

  5. Resistance exercise improves physical fatigue in women with fibromyalgia: a randomized controlled trial.

    Ericsson, Anna; Palstam, Annie; Larsson, Anette; Löfgren, Monika; Bileviciute-Ljungar, Indre; Bjersing, Jan; Gerdle, Björn; Kosek, Eva; Mannerkorpi, Kaisa

    2016-07-30

    Fibromyalgia (FM) affects approximately 1-3 % of the general population. Fatigue limits the work ability and social life of patients with FM. A few studies of physical exercise have included measures of fatigue in FM, indicating that exercise can decrease fatigue levels. There is limited knowledge about the effects of resistance exercise on multiple dimensions of fatigue in FM. The present study is a sub-study of a multicenter randomized controlled trial in women with FM. The purpose of the present sub-study was to examine the effects of a person-centered progressive resistance exercise program on multiple dimensions of fatigue in women with FM, and to investigate predictors of the potential change in fatigue. A total of 130 women with FM (age 22-64 years) were included in this assessor-blinded randomized controlled multicenter trial examining the effects of person-centered progressive resistance exercise compared with an active control group. The intervention was performed twice a week for 15 weeks. Outcomes were five dimensions of fatigue measured with the Multidimensional Fatigue Inventory (MFI-20). Information about background was collected and the women also completed several health-related questionnaires. Multiple linear stepwise regression was used to analyze predictors of change in fatigue in the total population. A higher improvement was found at the post-treatment examination for change in the resistance exercise group, as compared to change in the active control group in the MFI-20 subscale of physical fatigue (resistance group Δ -1.7, SD 4.3, controls Δ 0.0, SD 2.7, p = 0.013), with an effect size of 0.33. Sleep efficiency was the strongest predictor of change in the MFI-20 subscale general fatigue (beta = -0.54, p = 0.031, R (2) = 0.05). Participating in resistance exercise (beta = 1.90, p = 0.010) and working fewer hours per week (beta = 0.84, p = 0.005) were independent significant predictors of change in physical

  6. Decrease of fear avoidance beliefs following person-centered progressive resistance exercise contributes to reduced pain disability in women with fibromyalgia: secondary exploratory analyses from a randomized controlled trial.

    Palstam, Annie; Larsson, Anette; Löfgren, Monika; Ernberg, Malin; Bjersing, Jan; Bileviciute-Ljungar, Indre; Gerdle, Björn; Kosek, Eva; Mannerkorpi, Kaisa

    2016-05-21

    Fibromyalgia (FM) is characterized by persistent widespread pain, increased pain sensitivity and tenderness. Women with FM also report disability, in terms of negative consequences on activities of daily living. Our recent randomized controlled trial (RCT) is the first study of resistance exercise to show positive effects on pain disability. The resistance exercise program of our RCT emphasized active involvement of participants in planning and progression of the exercise, using the principles of person-centeredness, to support each participant's ability to manage the exercise and the progress of it. The aim of this sub-study was to investigate explanatory factors for reduced pain disability in women with FM participating in a 15-week person-centered progressive resistance exercise program. A total of 67 women with FM were included in this sub-study of an RCT examining the effects of person-centered progressive resistance exercise performed twice a week for 15 weeks. Tests of physical capacity and health-related questionnaires were assessed at baseline and after the intervention period. Multivariable stepwise regression was used to analyze explanatory factors for improvements in pain disability. Reduced pain disability was explained by higher pain disability at baseline together with decreased fear avoidance beliefs about physical activity (R (2) = 28, p = 0.005). The improvements in the disability domains of recreation and social activity were explained by decreased fear avoidance beliefs about physical activity together with higher baseline values of each disability domain respectively (R (2) = 32, p = 0.025 and R (2) = 30, p = 0.017). The improvement in occupational disability was explained by higher baseline values of occupational disability (R (2) = 19, p = 0.001). The person-centered resistance exercise intervention, based on principles of self-efficacy, had a positive effect on recreational, social and occupational disability

  7. Quality-of-Life After Everolimus-Eluting Stents or Bypass Surgery for Left-Main Disease: Results From the EXCEL Trial.

    Baron, Suzanne J; Chinnakondepalli, Khaja; Magnuson, Elizabeth A; Kandzari, David E; Puskas, John D; Ben-Yehuda, Ori; van Es, Gerrit-Anne; Taggart, David P; Morice, Marie-Claude; Lembo, Nicholas J; Brown, W Morris; Banning, Adrian; Simonton, Charles A; Kappetein, A Pieter; Sabik, Joseph F; Serruys, Patrick W; Stone, Gregg W; Cohen, David J

    2017-12-26

    The EXCEL (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial compared outcomes in patients with unprotected left main coronary artery disease (LMCAD) treated with coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) using everolimus-eluting stents. Whereas rates of death, stroke, and myocardial infarction were similar at 36 months, event timing and repeat revascularization rates differed by treatment group. To understand the effects of revascularization strategy from the patient's perspective, a prospective quality of life (QoL) substudy was performed alongside the EXCEL trial. Between September 2010 and March 2014, 1,905 patients with LMCAD were randomized to undergo CABG or PCI, of whom 1,788 participated in the QoL substudy. QoL was assessed at baseline and 1, 12, and 36 months using the Seattle Angina Questionnaire, the 12-Item Short Form Health Survey, the Rose Dyspnea Scale, the Patient Health Questionnaire-8, and the EQ-5D. Differences between PCI and CABG were assessed using longitudinal random-effect growth curve models. Over 36 months, both PCI and CABG were associated with significant improvements in QoL compared with baseline. At 1 month, PCI was associated with better QoL than CABG. By 12 months though, these differences were largely attenuated, and by 36 months, there were no significant QoL differences between PCI and CABG. Among selected patients with LMCAD, both PCI and CABG result in similar QoL improvement through 36 months, although a greater early benefit is seen with PCI. Taken together with the 3-year clinical results of EXCEL, these findings suggest that PCI and CABG provide similar intermediate-term outcomes for patients with LMCAD. (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier

  8. CECs and IL-8 Have Prognostic and Predictive Utility in Patients with Recurrent Platinum-Sensitive Ovarian Cancer: Biomarker Correlates from the Randomized Phase-2 Trial of Olaparib and Cediranib Compared with Olaparib in Recurrent Platinum-Sensitive Ovarian Cancer.

    Lee, Jung-Min; Trepel, Jane B; Choyke, Peter; Cao, Liang; Sissung, Tristan; Houston, Nicole; Yu, Minshu; Figg, William D; Turkbey, Ismail Baris; Steinberg, Seth M; Lee, Min-Jung; Ivy, S Percy; Liu, Joyce F; Matulonis, Ursula A; Kohn, Elise C

    2015-01-01

    Olaparib (O), a polyADPribose polymerase (PARP) inhibitor, and cediranib (C), a VEGF receptor (VEGFR)1-3 inhibitor together had greater activity than O alone in women with recurrent platinum-sensitive ovarian cancer (OvCa). The objective of this study is to identify potential lead biomarker candidates for response to O + C in the setting of a multi-institutional phase II study of O with and without C in recurrent platinum-sensitive OvCa. A self-selected group of patients participated in a prospectively planned exploratory biomarker substudy of the randomized phase II study of O versus O + C. Whole blood for peripheral blood mononuclear cell (PBMC) and plasma isolation was collected prior to and on day 3 of treatment. Quantitation of circulating endothelial cells (CEC), IL-6, IL-8, VEGF, and soluble VEGFR-2 plasma concentrations, and polyADPribose (PAR) incorporation were performed. Single nucleotide polymorphism analysis of XRCC1 280H, R194W, and Q399R was done. Dynamic contrast-enhanced-magnetic resonance imaging (DCE-MRI) was performed at baseline and day 3 of treatment. Parameter changes were compared between the two arms using an exact Wilcoxon rank sum test. Kaplan-Meier and log-rank tests were used to examine survival outcome. Thirteen patients elected to participate in the translational substudy, seven patients on O and six patients on O + C. Patients on O + C had a greater decrease in IL-8 concentration and larger CEC fold increase compared with those on O alone (p = 0.026, p = 0.032). The fold increase in CEC on day 3 was associated with duration of progression-free survival (PFS) (R (2) = 0.77, 95% CI 0.55-0.97, p < 0.001). IL-8 post-pretreatment changes correlate with PFS (p = 0.028). XRCC1 DNA polymorphisms were not related to PFS. All patients had reduction in PAR incorporation, and all except one had reduction in vascular flow on DCE-MRI. Our exploratory correlative studies indicate that CEC and IL-8 changes may be

  9. Kangaroo mother care for clinically unstable neonates weighing ≤2000 g: Is it feasible at a hospital in Uganda?

    Morgan, Melissa C; Nambuya, Harriet; Waiswa, Peter; Tann, Cally; Elbourne, Diana; Seeley, Janet; Allen, Elizabeth; Lawn, Joy E

    2018-06-01

    Kangaroo mother care (KMC) for stable neonates ≤2000 g (g) is associated with decreased mortality, sepsis, hypothermia, and length of stay compared to conventional care. The World Health Organization states that KMC "should be initiated… as soon as newborns are clinically stable " [12]. However, the majority of deaths occur in unstable neonates. We aimed to determine the proportion of admitted neonates meeting proposed instability criteria, assess the feasibility of providing KMC to unstable neonates, and evaluate the acceptability of this intervention to parents and providers at Jinja Regional Referral Hospital in Uganda. This was a mixed-methods study. We recorded data including birthweight, chronological age, and treatments administered from medical charts, and calculated the percentage of clinically unstable neonates, defined as the need for ≥2 medical therapies in the first 48 hours of admission. We enrolled a sample of neonates meeting pre-defined instability criteria. Mothers were counselled to provide KMC as close to continuously as possible. We calculated the median duration of KMC per episode and per day. To explore acceptability, we conducted semi-structured interviews with parents and newborn unit care providers, and analysed data using the thematic content approach. We included 254 neonates in the audit, 10 neonates in the feasibility sub-study, and 20 participants in the acceptability sub-study. Instability criteria were easily implementable, identifying 89% of neonates as unstable in the audit. The median duration of individual KMC episodes ranged from 115 to 134 minutes. The median daily duration ranged from 4.5 to 9.7 hours. Seventy-five percent of interviewees felt KMC could be used in neonates concurrently receiving other medical therapies. Barriers included lack of resources (beds/space, monitoring devices), privacy issues, inadequate education, and difficulties motivating mothers to devote time to KMC. Recommendations included staff

  10. Vegetarian diets and cardiovascular risk factors in black members of the Adventist Health Study-2.

    Fraser, Gary; Katuli, Sozina; Anousheh, Ramtin; Knutsen, Synnove; Herring, Patti; Fan, Jing

    2015-02-01

    To compare cardiovascular risk factors between vegetarians and non-vegetarians in black individuals living in the USA. A cross-sectional analysis of a sub-set of 592 black women and men enrolled in the Adventist Health Study-2 (AHS-2) cohort of Seventh-day Adventists. Members of the AHS-2 cohort, who lived in all states of the USA and provinces of Canada. Black/African-American members of two sub-studies of AHS-2 where blood and physiological measurements were obtained. Of these women and men, 25% were either vegan or lacto-ovo-vegetarians (labelled 'vegetarian/vegans'), 13% were pesco-vegetarian and 62% were non-vegetarian. Compared with non-vegetarians, the vegetarian/vegans had odds ratios for hypertension, diabetes, high blood total cholesterol and high blood LDL-cholesterol of 0·56 (95% CI 0·36, 0·87), 0·48 (95% CI 0·24, 0·98), 0·42 (95% CI 0·27, 0·65) and 0·54 (95% CI 0·33, 0·89), respectively, when adjusted for age, gender, education, physical activity and sub-study. Corresponding odds ratios for obesity in vegetarian/vegans and pesco-vegetarians, compared with non-vegetarians, were 0·43 (95% CI 0·28, 0·67) and 0·47 (95% CI 0·27, 0·81), respectively; and for abdominal obesity 0·54 (95% CI 0·36, 0·82) and 0·50 (95% CI 0·29, 0·84), respectively. Results for pesco-vegetarians did not differ significantly from those of non-vegetarians for other variables. Further adjustment for BMI suggested that BMI acts as an intermediary variable between diet and both hypertension and diabetes. As with non-blacks, these results suggest that there are sizeable advantages to a vegetarian diet in black individuals also, although a cross-sectional analysis cannot conclusively establish cause.

  11. Exposure-Response Relationship for Ombitasvir and Paritaprevir/Ritonavir in Hepatitis C Virus Subgenotype 1b-Infected Japanese Patients in the Phase 3 Randomized GIFT-I Study.

    Gopalakrishnan, Sathej; Khatri, Amit; Mensing, Sven; Redman, Rebecca; Menon, Rajeev; Zha, Jiuhong

    2016-04-01

    The all-oral 2 direct-acting antiviral (DAA) regimen of ombitasvir/paritaprevir/ritonavir 25/150/100 mg once a day has been evaluated in hepatitis C virus subgenotype 1b-infected Japanese adults in the GIFT-I study. The aim of this analysis was to evaluate potential relationships between DAA exposures and laboratory abnormalities/adverse events of peripheral edema in patients in GIFT-I. The GIFT-I study consisted of a randomized, double-blind, placebo-controlled substudy in patients without cirrhosis and an open-label substudy in patients with compensated cirrhosis. Patients received ombitasvir/paritaprevir/ritonavir for 12 weeks. Exposure-response relationships between individual components of the ombitasvir/paritaprevir/ritonavir regimen and clinical parameters of interest were explored using pharmacokinetic and clinical data from patients in the study. Graphical analyses were performed. For events that occurred in at least 10 patients (total bilirubin elevation ≥grade 2 and peripheral edema ≥grade 1), multivariate logistic regression analyses were used to identify significant relationships between predictor variables (drug exposures) and response variables (probability of adverse events or laboratory abnormalities), with consideration for the effect of potential covariates and baseline status of response variables. Data from 321 noncirrhotic and 42 compensated cirrhotic patients were analyzed. There were 14 events of peripheral edema (10 at grade 1 and 4 at grade 2) in patients who received concomitant administration of calcium channel blockers and ombitasvir/paritaprevir/ritonavir. There was no apparent relationship between the incidences of peripheral edema and exposures of paritaprevir, ombitasvir, or ritonavir. There was a shallow relationship between total bilirubin elevation and exposures of paritaprevir which is an inhibitor of bilirubin transporter organic anion-transporting polypeptide 1B. Based on graphical analyses, exposures of paritaprevir

  12. Participants' perspectives on making and maintaining behavioural changes in a lifestyle intervention for type 2 diabetes prevention: a qualitative study using the theory domain framework.

    Penn, Linda; Dombrowski, Stephan U; Sniehotta, Falko F; White, Martin

    2013-06-28

    In a qualitative substudy, we sought to elicit participants' perspectives of their behavioural change and maintenance of new behaviours towards intervention optimisation. The intervention was delivered in leisure and community settings in a local authority, which according to the UK government statistics ranks as 1 of the 10 most socioeconomically deprived areas in England. We recruited 218 adults aged 40-65 years at elevated risk of type 2 diabetes (Finnish Diabetes Risk Score≥11) to the intervention. Follow-up at 12 months was completed by 134 (62%). We recruited 15 participants, purposively sampled for physical activity increase, to the qualitative substudy. Lifestyle intervention can prevent type 2 diabetes, but translation to service provision remains challenging. The 'New life, New you' intervention aimed to promote physical activity, healthy eating and weight loss, and included supervised group physical activity sessions. Behavioural change and weight loss at 12-month follow-up were encouraging. We conducted 15 individual semistructured interviews. The Framework approach, with a comparison of emerging themes, was used in analysis of the transcribed data and complemented by the Theory Domains Framework. Themes emerging from the data were grouped as perceptions that promoted initiating, enacting and maintaining behavioural change. The data were then categorised in accordance with the Theory Domains Framework: intentions and goals; reinforcement; knowledge; social role and identity; social influences; skills and beliefs about capabilities; behavioural regulation, memory, emotion, attention and decision processes and environmental context and resources. Participant perceptions of intervention features that facilitated behavioural change processes were then similarly analysed. Social influences, reference to social role and identity (eg, peer support), and intentions and goals (eg, to lose weight) were dominant themes across the three phases of behavioural

  13. Vegetarian diets and cardiovascular risk factors in black members of the Adventist Health Study-2

    Fraser, Gary; Katuli, Sozina; Anousheh, Ramtin; Knutsen, Synnove; Herring, Patti; Fan, Jing

    2014-01-01

    Objective To compare cardiovascular risk factors between vegetarians and non-vegetarians in black individuals living in the USA. Design A cross-sectional analysis of a sub-set of 592 black women and men enrolled in the Adventist Health Study-2 (AHS-2) cohort of Seventh-day Adventists. Setting Members of the AHS-2 cohort, who lived in all states of the USA and provinces of Canada. Subjects Black/African-American members of two sub-studies of AHS-2 where blood and physiological measurements were obtained. Results Of these women and men, 25% were either vegan or lacto-ovo-vegetarians (labelled ‘vegetarian/vegans’), 13 % were pesco-vegetarian and 62% were non-vegetarian. Compared with non-vegetarians, the vegetarian/vegans had odds ratios for hypertension, diabetes, high blood total cholesterol and high blood LDL-cholesterol of 0·56 (95% CI 0·36, 0·87), 0·48 (95% CI 0·24, 0·98), 0·42 (95% CI 0·27, 0·65) and 0·54 (95% CI 0·33, 0·89), respectively, when adjusted for age, gender, education, physical activity and sub-study. Corresponding odds ratios for obesity in vegetarian/vegans and pesco-vegetarians, compared with non-vegetarians, were 0·43 (95% CI 0·28, 0·67) and 0·47 (95% CI 0·27, 0·81), respectively; and for abdominal obesity 0·54 (95% CI 0·36, 0·82) and 0·50 (95% CI 0·29, 0·84), respectively. Results for pesco-vegetarians did not differ significantly from those of non-vegetarians for other variables. Further adjustment for BMI suggested that BMI acts as an intermediary variable between diet and both hypertension and diabetes. Conclusions As with non-blacks, these results suggest that there are sizeable advantages to a vegetarian diet in black individuals also, although a cross-sectional analysis cannot conclusively establish cause. PMID:24636393

  14. The PiGeOn project: protocol of a longitudinal study examining psychosocial and ethical issues and outcomes in germline genomic sequencing for cancer.

    Best, Megan; Newson, Ainsley J; Meiser, Bettina; Juraskova, Ilona; Goldstein, David; Tucker, Kathy; Ballinger, Mandy L; Hess, Dominique; Schlub, Timothy E; Biesecker, Barbara; Vines, Richard; Vines, Kate; Thomas, David; Young, Mary-Anne; Savard, Jacqueline; Jacobs, Chris; Butow, Phyllis

    2018-04-23

    Advances in genomics offer promise for earlier detection or prevention of cancer, by personalisation of medical care tailored to an individual's genomic risk status. However genome sequencing can generate an unprecedented volume of results for the patient to process with potential implications for their families and reproductive choices. This paper describes a protocol for a study (PiGeOn) that aims to explore how patients and their blood relatives experience germline genomic sequencing, to help guide the appropriate future implementation of genome sequencing into routine clinical practice. We have designed a mixed-methods, prospective, cohort sub-study of a germline genomic sequencing study that targets adults with cancer suggestive of a genetic aetiology. One thousand probands and 2000 of their blood relatives will undergo germline genomic sequencing as part of the parent study in Sydney, Australia between 2016 and 2020. Test results are expected within12-15 months of recruitment. For the PiGeOn sub-study, participants will be invited to complete surveys at baseline, three months and twelve months after baseline using self-administered questionnaires, to assess the experience of long waits for results (despite being informed that results may not be returned) and expectations of receiving them. Subsets of both probands and blood relatives will be purposively sampled and invited to participate in three semi-structured qualitative interviews (at baseline and each follow-up) to triangulate the data. Ethical themes identified in the data will be used to inform critical revisions of normative ethical concepts or frameworks. This will be one of the first studies internationally to follow the psychosocial impact on probands and their blood relatives who undergo germline genome sequencing, over time. Study results will inform ongoing ethical debates on issues such as informed consent for genomic sequencing, and informing participants and their relatives of specific

  15. Nurse-led intervention to improve knowledge of medications in survivors of stroke or transient ischemic attack: a cluster randomized controlled trial

    Muideen Olaiya

    2016-11-01

    Full Text Available Introduction: Limited evidence exists on effective interventions to improve knowledge of preventive medications in patients with chronic diseases, such as stroke. We investigated the effectiveness of a nurse-led intervention, where a component was to improve knowledge of prevention medications, in patients with stroke or transient ischemic attack (TIA.Methods: Prospective sub-study of the Shared Team Approach between Nurses and Doctors For Improved Risk Factor Management (STAND FIRM, a randomized controlled trial of risk factor management. We recruited patients aged ≥18 years and hospitalized for stroke/TIA. The intervention comprised an individualized management program, involving nurse-led education, and management plan with medical specialist oversight. The outcome, participants’ knowledge of secondary prevention medications at 12 months, was assessed using questionnaires. A score of ≥5 was considered as good knowledge. Effectiveness of the intervention on knowledge of medications was determined using logistic regression. Results: Between May 2014 and January 2015, 142 consecutive participants from the main trial were included in this sub-study, 64 to usual care and 78 to the intervention (median age 68.9 years, 68% male, and 79% ischemic stroke. In multivariable analyses, we found no significant difference between intervention groups in knowledge of medications. Factors independently associated with good knowledge (score ≥5 at 12 months included higher socio-economic position (OR 4.79, 95% CI 1.76, 13.07, greater functional ability (OR 1.69, 95% CI 1.17, 2.45, being married/living with a partner (OR 3.12, 95% CI 1.10, 8.87, and using instructions on pill bottle/package as an administration aid (OR 4.82, 95% CI 1.76, 13.22. Being aged ≥65 years was associated with poorer knowledge of medications (OR 0.24, 95% CI 0.08, 0.71, while knowledge was worse among those taking three medications (OR 0.15, 95% CI 0.03, 0.66 or ≥4 medications

  16. CONTRACT Study - CONservative TReatment of Appendicitis in Children (feasibility): study protocol for a randomised controlled Trial.

    Hutchings, Natalie; Wood, Wendy; Reading, Isabel; Walker, Erin; Blazeby, Jane M; Van't Hoff, William; Young, Bridget; Crawley, Esther M; Eaton, Simon; Chorozoglou, Maria; Sherratt, Frances C; Beasant, Lucy; Corbett, Harriet; Stanton, Michael P; Grist, Simon; Dixon, Elizabeth; Hall, Nigel J

    2018-03-02

    Currently, the routine treatment for acute appendicitis in the United Kingdom is an appendicectomy. However, there is increasing scientific interest and research into non-operative treatment of appendicitis in adults and children. While a number of studies have investigated non-operative treatment of appendicitis in adults, this research cannot be applied to the paediatric population. Ultimately, we aim to perform a UK-based multicentre randomised controlled trial (RCT) to test the clinical and cost effectiveness of non-operative treatment of acute uncomplicated appendicitis in children, as compared with appendicectomy. First, we will undertake a feasibility study to assess the feasibility of performing such a trial. The study involves a feasibility RCT with a nested qualitative research to optimise recruitment as well as a health economic substudy. Children (aged 4-15 years inclusive) diagnosed with acute uncomplicated appendicitis that would normally be treated with an appendicectomy are eligible for the RCT. Exclusion criteria include clinical/radiological suspicion of perforated appendicitis, appendix mass or previous non-operative treatment of appendicitis. Participants will be randomised into one of two arms. Participants in the intervention arm are treated with antibiotics and regular clinical assessment to ensure clinical improvement. Participants in the control arm will receive appendicectomy. Randomisation will be minimised by age, sex, duration of symptoms and centre. Children and families who are approached for the RCT will be invited to participate in the embedded qualitative substudy, which includes recording of recruitment consultants and subsequent interviews with participants and non-participants and their families and recruiters. Analyses of these will inform interventions to optimise recruitment. The main study outcomes include recruitment rate (primary outcome), identification of strategies to optimise recruitment, performance of trial treatment

  17. Rationale and design of the Karolinska-Rennes (KaRen) prospective study of dyssynchrony in heart failure with preserved ejection fraction.

    Donal, Erwan; Lund, Lars H; Linde, Cecilia; Edner, Magnus; Lafitte, Stéphane; Persson, Hans; Bauer, Fabrice; Ohrvik, John; Ennezat, Pierre-Vladimir; Hage, Camilla; Löfman, Ida; Juilliere, Yves; Logeart, Damien; Derumeaux, Geneviève; Gueret, Pascal; Daubert, Jean-Claude

    2009-02-01

    Heart failure with preserved ejection fraction (HFPEF) is common but not well understood. Electrical dyssynchrony in systolic heart failure is harmful. Little is known about the prevalence and the prognostic impact of dyssynchrony in HFPEF. We have designed a prospective, multicenter, international, observational study to characterize HFPEF and to determine whether electrical or mechanical dyssynchrony affects prognosis. Patients presenting with acute heart failure (HF) will be screened so as to identify 400 patients with HFPEF. Inclusion criteria will be: acute presentation with Framingham criteria for HF, left ventricular ejection fraction>or=45%, brain natriuretic peptide (BNP)>100 pg/mL or NT-proBNP>300 pg/mL. Once stabilized, 4-8 weeks after the index presentation, patients will return and undergo questionnaires, serology, ECG, and Doppler echocardiography. Thereafter, patients will be followed for mortality and HF hospitalization every 6 months for at least 18 months. Sub-studies will focus on echocardiographic changes from the acute presentation to the stable condition and on exercise echocardiography, cardiopulmonary exercise testing, and serological markers. KaRen aims to characterize electrical and mechanical dyssynchrony and to assess its prognostic impact in HFPEF. The results might improve our understanding of HFPEF and generate answers to the question whether dyssynchrony could be a target for therapy in HFPEF.

  18. The utility of twins in developmental cognitive neuroscience research: How twins strengthen the ABCD research design.

    Iacono, William G; Heath, Andrew C; Hewitt, John K; Neale, Michael C; Banich, Marie T; Luciana, Monica M; Madden, Pamela A; Barch, Deanna M; Bjork, James M

    2018-08-01

    The ABCD twin study will elucidate the genetic and environmental contributions to a wide range of mental and physical health outcomes in children, including substance use, brain and behavioral development, and their interrelationship. Comparisons within and between monozygotic and dizygotic twin pairs, further powered by multiple assessments, provide information about genetic and environmental contributions to developmental associations, and enable stronger tests of causal hypotheses, than do comparisons involving unrelated children. Thus a sub-study of 800 pairs of same-sex twins was embedded within the overall Adolescent Brain and Cognitive Development (ABCD) design. The ABCD Twin Hub comprises four leading centers for twin research in Minnesota, Colorado, Virginia, and Missouri. Each site is enrolling 200 twin pairs, as well as singletons. The twins are recruited from registries of all twin births in each State during 2006-2008. Singletons at each site are recruited following the same school-based procedures as the rest of the ABCD study. This paper describes the background and rationale for the ABCD twin study, the ascertainment of twin pairs and implementation strategy at each site, and the details of the proposed analytic strategies to quantify genetic and environmental influences and test hypotheses critical to the aims of the ABCD study. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  19. Comparison of sodium, potassium, calcium, magnesium, zinc, copper and iron concentrations of elements in 24-h urine and spot urine in hypertensive patients with healthy renal function.

    Zhang, Tianjing; Chang, Xiaoyu; Liu, Wanlu; Li, Xiaoxia; Wang, Faxuan; Huang, Liping; Liao, Sha; Liu, Xiuying; Zhang, Yuhong; Zhao, Yi

    2017-12-01

    Sodium, potassium, calcium, magnesium, zinc, copper and iron are associated with the sequela of hypertension. The most reliable method for testing those elements is by collecting 24-h urine samples. However, this is cumbersome and collection of spot urine is more convenient in some circumstance. The aim of this study was to compare the concentrations of different elements in 24-h urine and spot urine. Data was collected from a sub-study of China Salt Substitute and Stroke Study. 240 participants were recruited randomly from 12 villages in two counties in Ningxia, China. Both spot and 24-h urine specimens were collected from each patient. Routine urine test was conducted, and concentration of elements was measured using microwave digestion and Inductively Coupled Plasma-Optical Emission Spectrometry. Partial correlation analysis and Spearman correlation analysis were used to investigate the concentration of different elements and the relationship between 24- h urine and spot urine. A partial correlation in sodium, potassium, calcium, magnesium and iron was found between paired 24-h urine and spot urine samples except copper and zinc: 0.430, 0.426, 0.550, 0.221 and 0.191 respectively. Spot urine can replace 24-h urine for estimating some of the elements in hypertensive patients with normal renal function. Copyright © 2017 Elsevier GmbH. All rights reserved.

  20. Changes in incontinence after hysterectomy.

    Kruse, Anne Raabjerg; Jensen, Trine Dalsgaard; Lauszus, Finn Friis; Kallfa, Ervin; Madsen, Mogens Rørbæk

    2017-10-01

    Information about the perioperative incontinence following hysterectomy is limited. To advance the postoperative rehabilitation further we need more information about qualitative changes in incontinence, fatigue and physical function of patients undergoing hysterectomy. 108 patients undergoing planned hysterectomy were compared pre- and postoperatively. In a sub-study of the prospective follow-up study the changes in incontinence, postoperative fatigue, quality of life, physical function, and body composition were evaluated preoperatively, 13 and 30 days postoperatively. Sample size calculation indicated that 102 women had to be included. The incontinence status was estimated by a Danish version of the ICIG questionnaire; further, visual analogue scale, dynamometer for hand grip, knee extension strength and balance were applied. Work capacity was measured ergometer cycle together with lean body mass by impedance. Quality of life was assessed using the SF-36 questionnaire. Patients were examined preoperatively and twice postoperatively. In total 41 women improved their incontinence after hysterectomy and 10 women reported deterioration. Preoperative stress incontinence correlated with BMI (r = 0.25, p effect on incontinence and de-novo cure.

  1. Total and Differential Phylloquinone (Vitamin K1 Intakes of Preterm Infants from All Sources during the Neonatal Period

    Paul Clarke

    2015-09-01

    Full Text Available All newborns require phylloquinone after birth to prevent vitamin K deficiency bleeding. Babies born prematurely may be at particular risk of deficiency without adequate supplementation during infancy. The main sources of phylloquinone in preterm babies during the neonatal period are the prophylactic dose of phylloquinone given at birth, and that derived from parenteral and/or enteral feeding. This observational study formed part of a prospective, multicentre, randomised, controlled trial that examined the vitamin K status of preterm infants after random allocation to one of three phylloquinone prophylactic regimens at birth (0.5 or 0.2 mg intramuscularly or 0.2 mg intravenously. In this nutritional sub-study we quantified the proportional and total phylloquinone intakes of preterm infants within the neonatal period from all sources. Almost all infants had average daily phylloquinone intakes that were in excess of the currently recommended amounts. In infants who did not receive parenteral nutrition, the bolus dose of phylloquinone given at birth was the major source of phylloquinone intake, whereas in infants who received parenteral nutrition, the intake from the parenteral preparation exceeded that from the bolus dose by a ratio of approximately 3:1. Our study supports the concern of others that preterm infants who receive current parenteral nutrition formulations may be receiving excessive vitamin K.

  2. Establishing the ACORN National Practitioner Database: Strategies to Recruit Practitioners to a National Practice-Based Research Network.

    Adams, Jon; Steel, Amie; Moore, Craig; Amorin-Woods, Lyndon; Sibbritt, David

    2016-10-01

    The purpose of this paper is to report on the recruitment and promotion strategies employed by the Australian Chiropractic Research Network (ACORN) project aimed at helping recruit a substantial national sample of participants and to describe the features of our practice-based research network (PBRN) design that may provide key insights to others looking to establish a similar network or draw on the ACORN project to conduct sub-studies. The ACORN project followed a multifaceted recruitment and promotion strategy drawing on distinct branding, a practitioner-focused promotion campaign, and a strategically designed questionnaire and distribution/recruitment approach to attract sufficient participation from the ranks of registered chiropractors across Australia. From the 4684 chiropractors registered at the time of recruitment, the project achieved a database response rate of 36% (n = 1680), resulting in a large, nationally representative sample across age, gender, and location. This sample constitutes the largest proportional coverage of participants from any voluntary national PBRN across any single health care profession. It does appear that a number of key promotional and recruitment features of the ACORN project may have helped establish the high response rate for the PBRN, which constitutes an important sustainable resource for future national and international efforts to grow the chiropractic evidence base and research capacity. Further rigorous enquiry is needed to help evaluate the direct contribution of specific promotional and recruitment strategies in attaining high response rates from practitioner populations who may be invited to participate in future PBRNs. Copyright © 2016. Published by Elsevier Inc.

  3. Perceived difficulty quitting predicts enrollment in a smoking-cessation program for patients with head and neck cancer.

    Duffy, Sonia A; Scheumann, Angela L; Fowler, Karen E; Darling-Fisher, Cynthia; Terrell, Jeffrey E

    2010-05-01

    To determine the predictors of participation in a smoking-cessation program among patients with head and neck cancer. This cross-sectional study is a substudy of a larger, randomized trial of patients with head and neck cancer that determined the predictors of smokers' participation in a cessation intervention. Otolaryngology clinics at three Veterans Affairs medical centers (Ann Arbor, MI, Gainesville, FL, and Dallas, TX), and the University of Michigan Hospital in Ann Arbor. 286 patients who had smoked within six months of the screening survey were eligible for a smoking-cessation intervention. Descriptive statistics and bivariate and multivariate logistic regression were used to determine the independent predictors of smokers' participation in an intervention study. Perceived difficulty quitting (as a construct of self-efficacy), health behaviors (i.e., smoking and problem drinking), clinical characteristics (i.e., depression and cancer site and stage), and demographic variables. Forty-eight percent of those eligible participated. High perceived difficulty quitting was the only statistically significant predictor of participation, whereas problem drinking, lower depressive symptoms, and laryngeal cancer site approached significance. Special outreach may be needed to reach patients with head and neck cancer who are overly confident in quitting, problem drinkers, and patients with laryngeal cancer. Oncology nurses are in an opportune position to assess patients' perceived difficulty quitting smoking and motivate them to enroll in cessation programs, ultimately improving quality of life, reducing risk of recurrence, and increasing survival for this population.

  4. Bezlotoxumab: A Review in Preventing Clostridium difficile Infection Recurrence.

    Deeks, Emma D

    2017-10-01

    Bezlotoxumab (Zinplava™) is a fully human monoclonal antibody against Clostridium difficile toxin B indicated for the prevention of C. difficile infection (CDI) recurrence in patients with a high recurrence risk. It is the first agent approved for recurrence prevention and is administered as a single intravenous infusion in conjunction with standard-of-care (SoC) antibacterial treatment for CDI. In well-designed, placebo-controlled, phase 3 trials (MODIFY 1 and 2), a single infusion of bezlotoxumab, given in combination with SoC antibacterial therapy for CDI in adults, was effective in reducing CDI recurrence in the 12 weeks post-treatment, with this benefit being seen mainly in the patients at high recurrence risk. Bezlotoxumab did not impact the efficacy of the antibacterials being used to treat the CDI and, consistent with its benefits on CDI recurrence, appeared to reduce the need for subsequent antibacterials, thus minimizing further gut microbiota disruption. Longer term, there were no further CDI recurrences over 12 months' follow-up among patients who had received bezlotoxumab in MODIFY 2 and entered an extension substudy. Bezlotoxumab has low immunogenicity and is generally well tolerated, although the potential for heart failure in some patients requires consideration; cost-effectiveness data for bezlotoxumab are awaited with interest. Thus, a single intravenous infusion of bezlotoxumab during SoC antibacterial treatment for CDI is an emerging option for reducing CDI recurrence in adults at high risk of recurrence.

  5. Serum sterol responses to increasing plant sterol intake from natural foods in the Mediterranean diet.

    Escurriol, Verónica; Cofán, Montserrat; Serra, Mercè; Bulló, Mónica; Basora, Josep; Salas-Salvadó, Jordi; Corella, Dolores; Zazpe, Itziar; Martínez-González, Miguel A; Ruiz-Gutiérrez, Valentina; Estruch, Ramón; Ros, Emilio

    2009-09-01

    Phytosterols in natural foods are thought to inhibit cholesterol absorption. The Mediterranean diet is rich in phytosterol-containing plant foods. To assess whether increasing phytosterol intake from natural foods was associated with a cholesterol-lowering effect in a substudy of a randomized trial of nutritional intervention with Mediterranean diets for primary cardiovascular prevention (PREDIMED study). One hundred and six high cardiovascular risk subjects assigned to two Mediterranean diets supplemented with virgin olive oil (VOO) or nuts, which are phytosterol-rich foods, or advice on a low-fat diet. Outcomes were 1-year changes in nutrient intake and serum levels of lipids and non-cholesterol sterols. Average phytosterol intake increased by 76, 158 and 15 mg/day in participants assigned VOO, nuts and low-fat diets, respectively. Compared to participants in the low-fat diet group, changes in outcome variables were observed only in those in the Mediterranean diet with nuts group, with increases in intake of fibre, polyunsaturated fatty acids and phytosterols (P natural foods appear to be bioactive in cholesterol lowering.

  6. Endogenous Pain Modulation Induced by Extrinsic and Intrinsic Psychological Threat in Healthy Individuals.

    Gibson, William; Moss, Penny; Cheng, Tak Ho; Garnier, Alexandre; Wright, Anthony; Wand, Benedict M

    2018-03-01

    Many factors interact to influence threat perception and the subsequent experience of pain. This study investigated the effect of observing pain (extrinsic threat) and intrinsic threat of pain to oneself on pressure pain threshold (PPT). Forty socially connected pairs of healthy volunteers were threat-primed and randomly allocated to experimental or control roles. An experimental pain modulation paradigm was applied, with non-nociceptive threat cues used as conditioning stimuli. In substudy 1, the extrinsic threat to the experimental participant was observation of the control partner in pain. The control participant underwent hand immersion in noxious and non-noxious water baths in randomized order. Change in the observing participant's PPT from baseline to mid- and postimmersion was calculated. A significant interaction was found for PPT between conditions and test time (F 2,78  = 24.9, P Extrinsic and intrinsic threat of pain, in the absence of any afferent input therefore influences pain modulation. This may need to be considered in studies that use noxious afferent input with populations who show dysfunctional pain modulation. The effect on endogenous analgesia of observing another's pain and of threat of pain to oneself was investigated. Extrinsic as well as intrinsic threat cues, in the absence of any afferent input, increased pain thresholds, suggesting that mere threat of pain may initiate analgesic effects in traditional noxious experimental paradigms. Copyright © 2017 The American Pain Society. Published by Elsevier Inc. All rights reserved.

  7. Trends and patterns in the use of computed tomography in children and young adults in Catalonia - results from the EPI-CT study

    Bosch de Basea, Magda; Cardis, Elisabeth; Salotti, Jane A.; Pearce, Mark S.; Muchart, Jordi; Riera, Luis; Barber, Ignasi; Pedraza, Salvador; Pardina, Marina; Capdevila, Antoni; Espinosa, Ana

    2016-01-01

    Although there are undeniable diagnostic benefits of CT scanning, its increasing use in paediatric radiology has become a topic of concern regarding patient radioprotection. To assess the rate of CT scanning in Catalonia, Spain, among patients younger than 21 years old at the scan time. This is a sub-study of a larger international cohort study (EPI-CT, the International pediatric CT scan study). Data were retrieved from the radiological information systems (RIS) of eight hospitals in Catalonia since the implementation of digital registration (between 1991 and 2010) until 2013. The absolute number of CT scans annually increased 4.5% between 1991 and 2013, which was less accentuated when RIS was implemented in most hospitals. Because the population attending the hospitals also increased, however, the rate of scanned patients changed little (8.3 to 9.4 per 1,000 population). The proportions of patients with more than one CT and more than three CTs showed a 1.51- and 2.7-fold increase, respectively, over the 23 years. Gradual increases in numbers of examinations and scanned patients were observed in Catalonia, potentially explained by new CT scanning indications and increases in the availability of scanners, the number of scans per patient and the size of the attended population. (orig.)

  8. Constructivism in Practice: an Exploratory Study of Teaching Patterns and Student Motivation in Physics Classrooms in Finland, Germany and Switzerland

    Beerenwinkel, Anne; von Arx, Matthias

    2017-04-01

    For the last three decades, moderate constructivism has become an increasingly prominent perspective in science education. Researchers have defined characteristics of constructivist-oriented science classrooms, but the implementation of such science teaching in daily classroom practice seems difficult. Against this background, we conducted a sub-study within the tri-national research project Quality of Instruction in Physics (QuIP) analysing 60 videotaped physics classes involving a large sample of students ( N = 1192) from Finland, Germany and Switzerland in order to investigate the kinds of constructivist components and teaching patterns that can be found in regular classrooms without any intervention. We applied a newly developed coding scheme to capture constructivist facets of science teaching and conducted principal component and cluster analyses to explore which components and patterns were most prominent in the classes observed. Two underlying components were found, resulting in two scales—Structured Knowledge Acquisition and Fostering Autonomy—which describe key aspects of constructivist teaching. Only the first scale was rather well established in the lessons investigated. Classes were clustered based on these scales. The analysis of the different clusters suggested that teaching physics in a structured way combined with fostering students' autonomy contributes to students' motivation. However, our regression models indicated that content knowledge is a more important predictor for students' motivation, and there was no homogeneous pattern for all gender- and country-specific subgroups investigated. The results are discussed in light of recent discussions on the feasibility of constructivism in practice.

  9. Sleep During Pregnancy: The nuMoM2b Pregnancy and Sleep Duration and Continuity Study.

    Reid, Kathryn J; Facco, Francesca L; Grobman, William A; Parker, Corette B; Herbas, Marcos; Hunter, Shannon; Silver, Robert M; Basner, Robert C; Saade, George R; Pien, Grace W; Manchanda, Shalini; Louis, Judette M; Nhan-Chang, Chia-Lang; Chung, Judith H; Wing, Deborah A; Simhan, Hyagriv N; Haas, David M; Iams, Jay; Parry, Samuel; Zee, Phyllis C

    2017-05-01

    To characterize sleep duration, timing and continuity measures in pregnancy and their association with key demographic variables. Multisite prospective cohort study. Women enrolled in the nuMoM2b study (nulliparous women with a singleton gestation) were recruited at the second study visit (16-21 weeks of gestation) to participate in the Sleep Duration and Continuity substudy. Women sleep log for 7 consecutive days. Time in bed, sleep duration, fragmentation index, sleep efficiency, wake after sleep onset, and sleep midpoint were averaged across valid primary sleep periods for each participant. Valid data were available from 782 women with mean age of 27.3 (5.5) years. Median sleep duration was 7.4 hours. Approximately 27.9% of women had a sleep duration of sleep duration of >9 hours. In multivariable models including age, race/ethnicity, body mass index, insurance status, and recent smoking history, sleep duration was significantly associated with race/ethnicity and insurance status, while time in bed was only associated with insurance status. Sleep continuity measures and sleep midpoint were significantly associated with all covariates in the model, with the exception of age for fragmentation index and smoking for wake after sleep onset. Our results demonstrate the relationship between sleep and important demographic characteristics during pregnancy. © Sleep Research Society 2017. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

  10. Conventional Wisdom versus Actual Outcomes: Challenges in the Conduct of an Ebola Vaccine Trial in Liberia during the International Public Health Emergency.

    Larson, Gregg S; Baseler, Beth R; Hoover, Marie L; Pierson, Jerome F; Tegli, Jemee K; Johnson, Melvin P; Kieh, Mark W S; McNay, Laura A; Njoh, Wissedi Sio

    2017-07-01

    Clinical trials are challenging endeavors. Planning and implementing an investigational vaccine trial in Liberia, in the midst of an Ebola virus disease (EVD) epidemic that World Health Organization classified a public health emergency of international concern, presented extraordinary challenges. Normally, years of preparation and a litany of tasks lay the groundwork for a successful, randomized, blinded, placebo-controlled trial focused on safety and efficacy. Difficult research settings, unpredictable events, and other unique circumstances can add complexity. The setting in Liberia was especially problematic due to an infrastructure still badly damaged following a lengthy civil war and a very fragile health-care system that was further devastated by the EVD outbreak. The Partnership for Research on Vaccines in Liberia I EVD vaccine trial was planned and implemented in less than 3 months by a Liberian and U.S. research partnership, and its Phase II substudy was fully enrolled 3 months later. Contrasting conventional wisdom with trial outcomes offers an opportunity to compare early assumptions, barriers encountered, and adaptive strategies used, with end results. Understanding what was learned can inform future trial responses when disease outbreaks, especially in resource-poor locations with minimal infrastructure, pose a significant threat to public health.

  11. Factors affecting outdoor exposure in winter: population-based study

    Mäkinen, Tiina M.; Raatikka, Veli-Pekka; Rytkönen, Mika; Jokelainen, Jari; Rintamäki, Hannu; Ruuhela, Reija; Näyhä, Simo; Hassi, Juhani

    2006-09-01

    The extent of outdoor exposure during winter and factors affecting it were examined in a cross-sectional population study in Finland. Men and women aged 25-74 years from the National FINRISK 2002 sub-study ( n=6,591) were queried about their average weekly occupational, leisure-time and total cold exposure during the past winter. The effects of gender, age, area of residence, occupation, ambient temperature, self-rated health, physical activity and education on cold exposure were analysed. The self-reported median total cold exposure time was 7 h/week (8 h men, 6 h women),employed in agriculture, forestry and industry/mining/construction or related occupations, being less educated and being aged 55-64 years. Factors associated with increased leisure-time cold exposure among men were: employment in industry/mining/construction or related occupations, being a pensioner or unemployed, reporting at least average health, being physically active and having college or vocational education. Among women, being a housewife, pensioner or unemployed and engaged in physical activity increased leisure-time cold exposure, and young women were more exposed than older ones. Self-rated health was positively associated with leisure time cold exposure in men and only to a minor extent in women. In conclusion, the subjects reported spending 4% of their total time under cold exposure, most of it (71%) during leisure time. Both occupational and leisure-time cold exposure is greater among men than women.

  12. HIV prevalence is strongly associated with geographical variations in male circumcision and foreskin cutting in Papua New Guinea: an ecological study.

    MacLaren, David J; McBride, W John H; Kelly, Gerard C; Muller, Reinhold; Tommbe, Rachael; Kaldor, John M; Vallely, Andrew J

    2015-11-01

    To examine the correlation between HIV prevalence and male circumcision and other foreskin cutting practices across the four regions of Papua New Guinea (PNG). An ecological substudy using unique data from an interdisciplinary research programme to evaluate the acceptability, sociocultural context and public health impact of male circumcision for HIV prevention in PNG. Published data describing (a) self-reported circumcision status by region from the 'Acceptability and Feasibility of Male Circumcision for HIV prevention in PNG' study and (b) HIV prevalence by region from PNG National Department of Health were used to correlate male circumcision and other foreskin cutting practices and HIV prevalence. Maps were constructed to visually represent variations across the four regions of PNG. Regions of PNG with the highest HIV prevalence had the lowest prevalence of male circumcision and other forms of foreskin cutting and vice versa. Male circumcision and dorsal longitudinal cuts were strongly associated with HIV prevalence and able to explain 99% of the observed geographical variability in HIV prevalence in PNG (pPNG appears to be closely correlated with the regional distribution of male circumcision and dorsal longitudinal foreskin cuts. Further research is warranted to investigate causality of this correlation as well as the potential of dorsal longitudinal cuts to confer protection against HIV acquisition in heterosexual men. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  13. Trends and patterns in the use of computed tomography in children and young adults in Catalonia - results from the EPI-CT study

    Bosch de Basea, Magda; Cardis, Elisabeth [Centre for Research in Environmental Epidemiology (CREAL), Barcelona (Spain); Universitat Pompeu Fabra (UPF), Barcelona (Spain); CIBER Epidemiologia y Salud Publica (CIBERESP), Barcelona (Spain); Salotti, Jane A.; Pearce, Mark S. [Royal Victoria Infirmary, Institute of Health and Society, Newcastle University, Sir James Spence Institute of Child Health, Newcastle upon Tyne (United Kingdom); Muchart, Jordi [Hospital Sant Joan de Deu Barcelona, Barcelona (Spain); Riera, Luis [Corporacio Sanitaria Parc Tauli, Sabadell (Spain); Barber, Ignasi [Hospital Universitari Vall d' Hebron, Barcelona (Spain); Pedraza, Salvador [Hospital Universitari de Girona Doctor Josep Trueta, Institut de Diagnostic per la Imatge (IDI), Girona (Spain); Institut d' Investigacio Biomedica de Girona Dr. Josep Trueta (IDIBGI), Girona (Spain); Universitat de Girona, Girona (Spain); Pardina, Marina [Hospital Universitari Arnau de Vilanova, Lleida (Spain); Capdevila, Antoni [Hospital de la Santa Creu i Sant Pau, Barcelona (Spain); Espinosa, Ana [Centre for Research in Environmental Epidemiology (CREAL), Barcelona (Spain); Universitat Pompeu Fabra (UPF), Barcelona (Spain); CIBER Epidemiologia y Salud Publica (CIBERESP), Barcelona (Spain); Hospital del Mar Medical Research Institute (IMIM), Barcelona (Spain)

    2016-01-15

    Although there are undeniable diagnostic benefits of CT scanning, its increasing use in paediatric radiology has become a topic of concern regarding patient radioprotection. To assess the rate of CT scanning in Catalonia, Spain, among patients younger than 21 years old at the scan time. This is a sub-study of a larger international cohort study (EPI-CT, the International pediatric CT scan study). Data were retrieved from the radiological information systems (RIS) of eight hospitals in Catalonia since the implementation of digital registration (between 1991 and 2010) until 2013. The absolute number of CT scans annually increased 4.5% between 1991 and 2013, which was less accentuated when RIS was implemented in most hospitals. Because the population attending the hospitals also increased, however, the rate of scanned patients changed little (8.3 to 9.4 per 1,000 population). The proportions of patients with more than one CT and more than three CTs showed a 1.51- and 2.7-fold increase, respectively, over the 23 years. Gradual increases in numbers of examinations and scanned patients were observed in Catalonia, potentially explained by new CT scanning indications and increases in the availability of scanners, the number of scans per patient and the size of the attended population. (orig.)

  14. Asthma control in general practice -- GP and patient perspectives compared.

    Henderson, Joan; Hancock, Kerry L; Armour, Carol; Harrison, Christopher; Miller, Graeme

    2013-10-01

    How general practitioners (GPs) and patients perceive asthma control, and concordance between these perceptions, may influence asthma management and medication adherence. The aims of this study were to determine asthma prevalence in adult patients, measure patient asthma control and the correlation between GP and patient perceptions of asthma control or impact. A Supplementary Analysis of Nominated Data (SAND) sub-study of the Bettering the Evaluation and Care of Health (BEACH) program surveyed 2563 patients from 103 GPs. Asthma control was measured using the Asthma Control Questionnaire 5-item version (ACQ-5), and medication adherence by patient self-report. Survey procedures in SAS software and Pearson's correlation statistics were used. Asthma prevalence was 12.7% (95% confidence interval: 10.9-14.5), with good correlation between GP and patient perceptions of asthma control/impact, and with raw ACQ-5 scores. Grouped ACQ-5 scores showed higher levels of uncontrolled asthma. Medication adherence was sub-optimal. The ACQ-5 questions are useful for assessing asthma control, for prompting medication reviews, and for reinforcing benefits of medication compliance to improve long-term asthma control.

  15. Circulating angiogenic cell function is inhibited by cortisol in vitro and associated with psychological stress and cortisol in vivo.

    Aschbacher, Kirstin; Derakhshandeh, Ronak; Flores, Abdiel J; Narayan, Shilpa; Mendes, Wendy Berry; Springer, Matthew L

    2016-05-01

    Psychological stress and glucocorticoids are associated with heightened cardiovascular disease risk. We investigated whether stress or cortisol would be associated with reduced circulating angiogenic cell (CAC) function, an index of impaired vascular repair. We hypothesized that minority-race individuals who experience threat in interracial interactions would exhibit reduced CAC function, and that this link might be explained by cortisol. To test this experimentally, we recruited 106 African American participants for a laboratory interracial interaction task, in which they received socially evaluative feedback from Caucasian confederates. On a separate day, a subset of 32 participants (mean age=26years, 47% female) enrolled in a separate biological substudy and provided blood samples for CAC isolation and salivary samples to quantify the morning peak in cortisol (the cortisol awakening response, CAR). CAC function was quantified using cell culture assays of migration to vascular endothelial growth factor (VEGF) and secretion of VEGF into the culture medium. Heightened threat in response to an interracial interaction and trait anxiety in vivo were both associated with poorer CAC migratory function in vitro. Further, threat and poorer sustained attention during the interracial interaction were associated with a higher CAR, which in turn, was related to lower CAC sensitivity to glucocorticoids. In vitro, higher doses of cortisol impaired CAC migratory function and VEGF protein secretion. The glucocorticoid receptor antagonist RU486 reversed this functional impairment. These data identify a novel, neuroendocrine pathway by which psychological stress may reduce CAC function, with potential implications for cardiovascular health. Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. Inflammatory Response After Laparoscopic Versus Open Resection of Colorectal Liver Metastases: Data From the Oslo-CoMet Trial.

    Fretland, Asmund Avdem; Sokolov, Andrey; Postriganova, Nadya; Kazaryan, Airazat M; Pischke, Soren E; Nilsson, Per H; Rognes, Ingrid Nygren; Bjornbeth, Bjorn Atle; Fagerland, Morten Wang; Mollnes, Tom Eirik; Edwin, Bjorn

    2015-10-01

    Laparoscopic and open liver resection have not been compared in randomized trials. The aim of the current study was to compare the inflammatory response after laparoscopic and open resection of colorectal liver metastases (CLM) in a randomized controlled trial.This was a predefined exploratory substudy within the Oslo CoMet-study. Forty-five patients with CLM were randomized to laparoscopic (n = 23) or open (n = 22) resection. Ethylenediaminetetraacetic acid-plasma samples were collected preoperatively and at defined time points during and after surgery and snap frozen at -80 C. A total of 25 markers were examined using luminex and enzyme-linked immunosorbent assay techniques: high-mobility box group 1(HMGB-1), cell-free DNA (cfDNA), cytokines, and terminal C5b-9 complement complex complement activation.Eight inflammatory markers increased significantly from baseline: HMGB-1, cfDNA, interleukin (IL)-6, C-reactive protein, macrophage inflammatory protein -1β, monocyte chemotactic protein -1, IL-10, and terminal C5b-9 complement complex. Peak levels were reached at the end of or shortly after surgery. Five markers, HMGB-1, cfDNA, IL-6, C-reactive protein, and macrophage inflammatory protein -1β, showed significantly higher levels in the open surgery group compared with the laparoscopic surgery group.Laparoscopic resection of CLM reduced the inflammatory response compared with open resection. The lower level of HMGB-1 is interesting because of the known association with oncogenesis.

  17. Heliox Improves Carbon Dioxide Removal during Lung Protective Mechanical Ventilation.

    Beurskens, Charlotte J; Brevoord, Daniel; Lagrand, Wim K; van den Bergh, Walter M; Vroom, Margreeth B; Preckel, Benedikt; Horn, Janneke; Juffermans, Nicole P

    2014-01-01

    Introduction. Helium is a noble gas with low density and increased carbon dioxide (CO2) diffusion capacity. This allows lower driving pressures in mechanical ventilation and increased CO2 diffusion. We hypothesized that heliox facilitates ventilation in patients during lung-protective mechanical ventilation using low tidal volumes. Methods. This is an observational cohort substudy of a single arm intervention study. Twenty-four ICU patients were included, who were admitted after a cardiac arrest and mechanically ventilated for 3 hours with heliox (50% helium; 50% oxygen). A fixed protective ventilation protocol (6 mL/kg) was used, with prospective observation for changes in lung mechanics and gas exchange. Statistics was by Bonferroni post-hoc correction with statistical significance set at P ventilation, respiratory rate decreased (25 ± 4 versus 23 ± 5 breaths min(-1), P = 0.010). Minute volume ventilation showed a trend to decrease compared to baseline (11.1 ± 1.9 versus 9.9 ± 2.1 L min(-1), P = 0.026), while reducing PaCO2 levels (5.0 ± 0.6 versus 4.5 ± 0.6 kPa, P = 0.011) and peak pressures (21.1 ± 3.3 versus 19.8 ± 3.2 cm H2O, P = 0.024). Conclusions. Heliox improved CO2 elimination while allowing reduced minute volume ventilation in adult patients during protective mechanical ventilation.

  18. The Effects of General System Justification on Corruption Perception and Intent.

    Tan, Xuyun; Liu, Li; Huang, Zhenwei; Zheng, Wenwen; Liang, Yuan

    2016-01-01

    Previous research stresses that system justifying belief can weaken corruption perception, by this possibly fostering unjust behaviors. However, general results of the effect of general system justification on corruption are ambiguous, indicating also a lessening impact. We conducted a line of studies trying to elucidate these circumstances by testing the effect of general system justification on corruption perception and intention. In addition, we explored institutional trust as a possible mediator in this process. For this purpose, we conducted three studies. The first two studies examined the association between general system justification and corruption. In Study 1, a correlational design was run using questionnaires to assess the relation between general system justification and corruption perception as well as corruption intention. In Study 2, an experimental design was conducted manipulating general system justification via exposure to high or low system threat condition, then measuring its effect on corruption perception and corrupt intention. In Study 3, two sub-studies using correlational and experimental designs were run to explore the mediating role of institutional trust, respectively. Results replicated former studies showing that general system justification is negatively associated with corruption perception. However, they also showed a negative correlation with corrupt intention. Furthermore, they showed that institutional trust mediated the relation between general system justification and corruption. We suggest to consider these findings to further elucidate the psychological basis underlying different effects of general system justification on human behaviors.

  19. A facilitated approach to family case conferencing for people with advanced dementia living in nursing homes: perceptions of palliative care planning coordinators and other health professionals in the IDEAL study.

    Luckett, Tim; Chenoweth, Lynnette; Phillips, Jane; Brooks, Deborah; Cook, Janet; Mitchell, Geoffrey; Pond, Dimity; Davidson, Patricia M; Beattie, Elizabeth; Luscombe, Georgina; Goodall, Stephen; Fischer, Thomas; Agar, Meera

    2017-10-01

    Palliative care for nursing home residents with advanced dementia is often sub-optimal due to poor communication and limited care planning. In a cluster randomized controlled trial, registered nurses (RNs) from 10 nursing homes were trained and funded to work as Palliative Care Planning Coordinators (PCPCs) to organize family case conferences and mentor staff. This qualitative sub-study aimed to explore PCPC and health professional perceptions of the benefits of facilitated case conferencing and identify factors influencing implementation. Semi-structured interviews were conducted with the RNs in the PCPC role, other members of nursing home staff, and physicians who participated in case conferences. Analysis was conducted by two researchers using a thematic framework approach. Interviews were conducted with 11 PCPCs, 18 other nurses, eight allied health workers, and three physicians. Perceived benefits of facilitated case conferencing included better communication between staff and families, greater multi-disciplinary involvement in case conferences and care planning, and improved staff attitudes and capabilities for dementia palliative care. Key factors influencing implementation included: staffing levels and time; support from management, staff and physicians; and positive family feedback. The facilitated approach explored in this study addressed known barriers to case conferencing. However, current business models in the sector make it difficult for case conferencing to receive the required levels of nursing qualification, training, and time. A collaborative nursing home culture and ongoing relationships with health professionals are also prerequisites for success. Further studies should document resident and family perceptions to harness consumer advocacy.

  20. Age and CD4 count at initiation of antiretroviral therapy in HIV-infected children: effects on long-term T-cell reconstitution.

    Lewis, Joanna; Walker, A Sarah; Castro, Hannah; De Rossi, Anita; Gibb, Diana M; Giaquinto, Carlo; Klein, Nigel; Callard, Robin

    2012-02-15

    Effective therapies and reduced AIDS-related morbidity and mortality have shifted the focus in pediatric human immunodeficiency virus (HIV) from minimizing short-term disease progression to maintaining optimal long-term health. We describe the effects of children's age and pre-antiretroviral therapy (ART) CD4 count on long-term CD4 T-cell reconstitution. CD4 counts in perinatally HIV-infected, therapy-naive children in the Paediatric European Network for the Treatment of AIDS 5 trial were monitored following initiation of ART for a median 5.7 years. In a substudy, naive and memory CD4 counts were recorded. Age-standardized measurements were analyzed using monophasic, asymptotic nonlinear mixed-effects models. One hundred twenty-seven children were studied. Older children had lower age-adjusted CD4 counts in the long term and at treatment initiation (P memory CD4 counts increased less, albeit on a faster timescale. It appears the immature immune system can recover well from HIV infection via the naive pool. However, this potential is progressively damaged with age and/or duration of infection. Current guidelines may therefore not optimize long-term immunological health.

  1. Rationale for nebivolol/valsartan combination for hypertension: review of preclinical and clinical data.

    Giles, Thomas D; Cockcroft, John R; Pitt, Bertram; Jakate, Abhijeet; Wright, Harold M

    2017-09-01

    : To treat hypertension, combining two or more antihypertensive drugs from different classes is often necessary. β-Blockers and renin-angiotensin-aldosterone system inhibitors, when combined, have been deemed 'less effective' based on partially overlapping mechanisms of action and limited evidence. Recently, the single-pill combination (SPC) of nebivolol (Neb) 5 mg - a vasodilatory β1-selective antagonist/β3 agonist - and valsartan 80 mg, an angiotensin II receptor blocker, was US Food and Drug Administration-approved for hypertension. Pharmacological profiles of Neb and valsartan, alone and combined, are well characterized. In addition, a large 8-week randomized trial in stages I-II hypertensive patients (N = 4161) demonstrated greater blood pressure-reducing efficacy for Neb/valsartan SPCs than component monotherapies with comparable tolerability. In a biomarkers substudy (N = 805), Neb/valsartan SPCs prevented valsartan-induced increases in plasma renin, and a greater reduction in plasma aldosterone was observed with the highest SPC dose vs. valsartan 320 mg/day. This review summarizes preclinical and clinical evidence supporting Neb/valsartan as an efficacious and well tolerated combination treatment for hypertension.

  2. Correlations of plasma renin activity and aldosterone concentration with ambulatory blood pressure responses to nebivolol and valsartan, alone and in combination, in hypertension.

    Giles, Thomas D; Bakris, George; Oparil, Suzanne; Weber, Michael A; Li, Huiling; Mallick, Madhuja; Bharucha, David B; Chen, ChunLin; Ferguson, William G

    2015-11-01

    After demonstration of the antihypertensive efficacy of the combination of the beta-blocker nebivolol and the angiotensin receptor blocker valsartan in an 8-week, randomized, placebo-controlled trial (N = 4161), we now report the effects of this treatment on the renin-angiotensin-aldosterone system in a substudy (n = 805). Plasma renin activity increased with valsartan (54%-73%) and decreased with nebivolol (51%-65%) and the combination treatment (17%-39%). Plasma aldosterone decreased with individual treatments (valsartan, 11%-22%; nebivolol, 20%-26%), with the largest reduction (35%) observed with maximum combination dose (20 mg nebivolol/320 mg valsartan). Baseline ln(plasma renin activity) correlated with the 8-week reductions in 24-hour systolic and diastolic BP following treatments with the combination (all doses combined, P = .003 and P valsartan. Baseline ln(aldosterone) correlated with 24-hour systolic and diastolic BP reductions following combination treatment only (P < .001 and P = .005). The implications of the renin-angiotensin-aldosterone system effects of this beta blocker-angiotensin receptor blocker combination should be explored further. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  3. May thrombopoietin be a useful marker of sepsis severity assessment in patients with SIRS entering the emergency department?

    Segre, Elisabetta; Pigozzi, Luca; Lison, Davide; Pivetta, Emanuele; Bosco, Ornella; Vizio, Barbara; Suppo, Umberto; Turvani, Fabrizio; Morello, Fulvio; Battista, Stefania; Moiraghi, Corrado; Montrucchio, Giuseppe; Lupia, Enrico

    2014-10-01

    Thrombopoietin (TPO), a growth factor primarily involved in regulating thrombopoiesis, has been recently implicated in the pathogenesis of sepsis. TPO levels are, indeed, greatly increased in patients with sepsis compared to control subjects, and correlate with sepsis severity. The aim of this study was to evaluate TPO as predictive biomarker of sepsis and of sepsis severity in patients entering the emergency department (ED) with systemic inflammatory response syndrome (SIRS). This was a prospective observational study. Ours is a sub-study of the 'Need-speed trial', a multi-center observational study involving six Italian centers affiliated to the GREAT Italian Network. TPO was measured by ELISA. We enrolled 13 patients with SIRS (6 with acute pancreatitis, 3 with acute heart failure, 1 with pulmonary embolism, and 3 with allergic reactions), and 40 patients with sepsis, eight of whom had severe sepsis and three septic shock. TPO was significantly higher in patients with sepsis than with SIRS. In addition, TPO was higher in patients with severe sepsis than with sepsis, and in patients with septic shock than with severe sepsis, although these differences did not reach the statistical significance. Our preliminary results suggest that TPO may have the potential to be considered a promising early biomarker for both the diagnosis of sepsis and the assessment of sepsis severity in patients with SIRS entering the ED.

  4. The effect of individual antiretroviral drugs on body composition in HIV-infected persons initiating highly active antiretroviral therapy.

    Shlay, Judith C; Sharma, Shweta; Peng, Grace; Gibert, Cynthia L; Grunfeld, Carl

    2009-07-01

    To examine the long-term effects of individual antiretroviral drugs on body composition among 416 persons initiating antiretroviral therapy (ART). In a substudy of a clinical trial of persons initiating ART, changes in body composition attributable to individual ART were examined. ARTs assessed were as follows: indinavir, ritonavir, nelfinavir, efavirenz, nevirapine, stavudine (d4T), zidovudine (ZDV), lamivudine (3TC), didanosine, and abacavir. Skinfolds and circumferences were measured at baseline and every 4 months. Mid arm, mid thigh, and waist subcutaneous tissue areas and nonsubcutaneous tissue areas were calculated. Rates of change per year of exposure to each individual ART drug were determined using multivariate longitudinal regression. d4T and ZDV use was associated with losses in subcutaneous tissue area and skinfold thickness. 3TC use was associated with gains in all subcutaneous tissue areas and skinfold thickness, whereas abacavir use was associated with an increase in waist subcutaneous tissue area. Indinavir was associated with gains in waist subcutaneous tissue area, whereas indinavir, efavirenz, and nevirapine were associated with increases in upper back skinfolds. d4T use was also associated with increases in all nonsubcutaneous tissue areas; 3TC use was associated with the greatest increase in waist nonsubcutaneous tissue area. In this prospective nonrandomized evaluation, the nucleoside reverse transcriptase inhibitors d4T and ZDV were associated with decreases in subcutaneous tissue areas, whereas 3TC use was associated with increased subcutaneous tissue areas and waist nonsubcutaneous tissue area.

  5. Nippon Storm Study design

    Takashi Kurita

    2012-10-01

    Full Text Available An understanding of the clinical aspects of electrical storm (E-storms in patients with implantable cardiac shock devices (ICSDs: ICDs or cardiac resynchronization therapy with defibrillator [CRT-D] may provide important information for clinical management of patients with ICSDs. The Nippon Storm Study was organized by the Japanese Heart Rhythm Society (JHRS and Japanese Society of Electrocardiology and was designed to prospectively collect a variety of data from patients with ICSDs, with a focus on the incidence of E-storms and clinical conditions for the occurrence of an E-storm. Forty main ICSD centers in Japan are participating in the present study. From 2002, the JHRS began to collect ICSD patient data using website registration (termed Japanese cardiac defibrillator therapy registration, or JCDTR. This investigation aims to collect data on and investigate the general parameters of patients with ICSDs, such as clinical backgrounds of the patients, purposes of implantation, complications during the implantation procedure, and incidence of appropriate and inappropriate therapies from the ICSD. The Nippon Storm Study was planned as a sub-study of the JCDTR with focus on E-storms. We aim to achieve registration of more than 1000 ICSD patients and complete follow-up data collection, with the assumption of a 5–10% incidence of E-storms during the 2-year follow-up.

  6. HIV testing and risk perceptions: a qualitative analysis of secondary school students in Kampala, Uganda

    George Aluzimbi

    2017-07-01

    Full Text Available The purpose of this paper is to explore the perceptions of self-reported HIV testing and risk behavior among sexually active adolescents and youth in secondary schools in Kampala Uganda. This was a cross-sectional survey conducted between June and October 2010 among secondary school students in Kampala, Uganda. Forty eight (48 students across the 54 schools were purposively selected for the qualitative sub-study based on their responses to particular questions. We thematically analyzed 28 interviews for our qualitative study using Nvivo software. Drug and alcohol use coupled with peers pressure impaired students’ perceptions towards HIV risk and therefore increased their susceptibility to HIV risk behaviors. Of the 28 scripts analyzed, 82% (23/28 had ever had sexual partners, 79% (22/28 were currently sexually active, and 57% (16/28 had ever been tested for HIV. In conclusion, most adolescents interviewed did not perceive HIV testing to be important to HIV prevention and reported low perception of susceptibility to HIV infection. Development of an adolescent HIV prevention model is important in improving uptake of HIV services.

  7. Negotiating the Use of Female-Initiated HIV Prevention Methods in a Context of Gender-Based Violence: the Narrative of Rape

    Hartmann, Miriam; Montgomery, Elizabeth; Stadler, Jonathan; Laborde, Nicole; Magazi, Busisiwe; Mathebula, Florence; van der Straten, Ariane

    2016-01-01

    Female-initiated methods of HIV prevention are needed to address barriers to HIV prevention rooted in gender inequalities. Understanding the socio-cultural context of pre-exposure prophylaxis (PrEP) trials, including gender-based violence, is thus critical. MTN-003C (VOICE-C), a qualitative sub-study of the larger MTN-003 (VOICE) trial, examined socio-cultural barriers and facilitators to PrEP amongst women in Johannesburg. We conducted focus group discussions, in-depth interviews, and ethnographic interviews with 102 trial participants, 22 male partners, 17 community advisory board members, and 23 community stakeholders. We analysed how discussions of rape are emblematic of the gendered context in which HIV risk occurs. Rape emerged spontaneously in half of discussions with community advisory board members, two-thirds with stakeholders and among one-fifth of interviews/discussions with trial participants. Rape was used to reframe HIV risk as external to women’s or partner’s behaviour and to justify the importance of PrEP. Our research illustrates how women, in contexts of high levels of sexual violence, may use existing gender inequalities to negotiate PrEP use. This suggests that future interventions should simultaneously address harmful gender attitudes, as well as equip women with alternative means to negotiate product use, in order to more effectively empower women to protect themselves from HIV. PMID:26551920

  8. Long-term doctor-patient relationships: patient perspective from online reviews.

    Detz, Alissa; López, Andrea; Sarkar, Urmimala

    2013-07-02

    Continuity of patient care is one of the cornerstones of primary care. To examine publicly available, Internet-based reviews of adult primary care physicians, specifically written by patients who report long-term relationships with their physicians. This substudy was nested within a larger qualitative content analysis of online physician ratings. We focused on reviews reflecting an established patient-physician relationship, that is, those seeing their physicians for at least 1 year. Of the 712 Internet reviews of primary care physicians, 93 reviews (13.1%) were from patients that self-identified as having a long-term relationship with their physician, 11 reviews (1.5%) commented on a first-time visit to a physician, and the remainder of reviews (85.4%) did not specify the amount of time with their physician. Analysis revealed six overarching domains: (1) personality traits or descriptors of the physician, (2) technical competence, (3) communication, (4) access to physician, (5) office staff/environment, and (6) coordination of care. Our analysis shows that patients who have been with their physician for at least 1 year write positive reviews on public websites and focus on physician attributes.

  9. A bivariate measurement error model for semicontinuous and continuous variables: Application to nutritional epidemiology.

    Kipnis, Victor; Freedman, Laurence S; Carroll, Raymond J; Midthune, Douglas

    2016-03-01

    Semicontinuous data in the form of a mixture of a large portion of zero values and continuously distributed positive values frequently arise in many areas of biostatistics. This article is motivated by the analysis of relationships between disease outcomes and intakes of episodically consumed dietary components. An important aspect of studies in nutritional epidemiology is that true diet is unobservable and commonly evaluated by food frequency questionnaires with substantial measurement error. Following the regression calibration approach for measurement error correction, unknown individual intakes in the risk model are replaced by their conditional expectations given mismeasured intakes and other model covariates. Those regression calibration predictors are estimated using short-term unbiased reference measurements in a calibration substudy. Since dietary intakes are often "energy-adjusted," e.g., by using ratios of the intake of interest to total energy intake, the correct estimation of the regression calibration predictor for each energy-adjusted episodically consumed dietary component requires modeling short-term reference measurements of the component (a semicontinuous variable), and energy (a continuous variable) simultaneously in a bivariate model. In this article, we develop such a bivariate model, together with its application to regression calibration. We illustrate the new methodology using data from the NIH-AARP Diet and Health Study (Schatzkin et al., 2001, American Journal of Epidemiology 154, 1119-1125), and also evaluate its performance in a simulation study. © 2015, The International Biometric Society.

  10. Using Mid-Sleep Time to Determine Chronotype in Young Adults with Insomnia-Related Symptoms

    Sooyeon Suh

    2017-12-01

    Full Text Available The Munich Chronotype Questionnaire (MCTQ uses sleep behavior to assess chronotype, but the extent to which such sleep behavior based assessments might be useful in populations with sleep disorders, such as insomnia, is currently unclear. We thus systematically assessed sleep disorders, MCTQ and the Morningness-Eveningness Questionnaire (MEQ, another behavioral preferencebased assessment of chronotype, in 310 individuals. In a smaller substudy (n = 121, we compared the MCTQ to sleep diaries in insomnia patients and good sleepers. Insomnia patients had overall lower consistency in chronotypes compared to good sleepers on the MCTQ compared to the MEQ, which was also evident when compared to sleep diaries. As insomnia disorder is characterized by time gaps spent awake during the night due to difficulty maintaining sleep, there may be limitations in using mid-sleep time as an accurate indicator of chronotype in insomnia patients. Our study suggests that the MCTQ should be used in conjunction with another existing questionnaire or assessment tool when assessing chronotype in insomnia patients.

  11. Methods to control for unmeasured confounding in pharmacoepidemiology: an overview.

    Uddin, Md Jamal; Groenwold, Rolf H H; Ali, Mohammed Sanni; de Boer, Anthonius; Roes, Kit C B; Chowdhury, Muhammad A B; Klungel, Olaf H

    2016-06-01

    Background Unmeasured confounding is one of the principal problems in pharmacoepidemiologic studies. Several methods have been proposed to detect or control for unmeasured confounding either at the study design phase or the data analysis phase. Aim of the Review To provide an overview of commonly used methods to detect or control for unmeasured confounding and to provide recommendations for proper application in pharmacoepidemiology. Methods/Results Methods to control for unmeasured confounding in the design phase of a study are case only designs (e.g., case-crossover, case-time control, self-controlled case series) and the prior event rate ratio adjustment method. Methods that can be applied in the data analysis phase include, negative control method, perturbation variable method, instrumental variable methods, sensitivity analysis, and ecological analysis. A separate group of methods are those in which additional information on confounders is collected from a substudy. The latter group includes external adjustment, propensity score calibration, two-stage sampling, and multiple imputation. Conclusion As the performance and application of the methods to handle unmeasured confounding may differ across studies and across databases, we stress the importance of using both statistical evidence and substantial clinical knowledge for interpretation of the study results.

  12. A cross-sectional analysis of traditional medicine use for malaria alongside free antimalarial drugs treatment amongst adults in high-risk malaria endemic provinces of Indonesia.

    Suswardany, Dwi Linna; Sibbritt, David W; Supardi, Sudibyo; Pardosi, Jerico F; Chang, Sungwon; Adams, Jon

    2017-01-01

    The level of traditional medicine use, particularly Jamu use, in Indonesia is substantial. Indonesians do not always seek timely treatment for malaria and may seek self-medication via traditional medicine. This paper reports findings from the first focused analyses of traditional medicine use for malaria in Indonesia and the first such analyses worldwide to draw upon a large sample of respondents across high-risk malaria endemic areas. A sub-study of the Indonesia Basic Health Research/Riskesdas Study 2010 focused on 12,226 adults aged 15 years and above residing in high-risk malaria-endemic provinces. Logistic regression was undertaken to determine the significant associations for traditional medicine use for malaria symptoms. Approximately one in five respondents use traditional medicine for malaria symptoms and the vast majority experiencing multiple episodes of malaria use traditional medicine alongside free antimalarial drug treatments. Respondents consuming traditional medicine for general health/common illness purposes every day (odds ratio: 3.75, 95% Confidence Interval: 2.93 4.79), those without a hospital in local vicinity (odds ratio: 1.31, 95% Confidence Interval: 1.10 1.57), and those living in poorer quality housing, were more likely to use traditional medicine for malaria symptoms. A substantial percentage of those with malaria symptoms utilize traditional medicine for treating their malaria symptoms. In order to promote safe and effective malaria treatment, all providing malaria care in Indonesia need to enquire with their patients about possible traditional medicine use.

  13. Development and preliminary evaluation of a new anatomically based prosthetic alignment method for below-knee prosthesis.

    Tafti, Nahid; Karimlou, Masoud; Mardani, Mohammad Ali; Jafarpisheh, Amir Salar; Aminian, Gholam Reza; Safari, Reza

    2018-04-20

    The objectives of current study were to a) assess similarities and relationships between anatomical landmark-based angles and distances of lower limbs in unilateral transtibial amputees and b) develop and evaluate a new anatomically based static prosthetic alignment method. First sub-study assessed the anthropometrical differences and relationships between the lower limbs in the photographs taken from amputees. Data were analysed via paired t-test and regression analysis. Results show no significant differences in frontal and transverse planes. In the sagittal plane, the anthropometric parameters of the amputated limb were significantly correlated to the corresponding variables of the sound limb. The results served as bases for the development of a new prosthetic alignment method. The method was evaluated on a single subject study. Prosthetic alignment carried out by an experienced prosthetist was compared with such alignment adjusted by an inexperienced prosthetist but with the use of the developed method. In sagittal and frontal planes, the socket angle was tuned with respect to the shin angle, and the position of the prosthetic foot was tuned in relation to the pelvic landmarks. Further study is needed to assess the proposed method on a larger sample of amputees and prosthetists.

  14. The value of a rapid contrast-enhanced angio-MRI protocol in the detection of head and neck paragangliomas in SDHx mutations carriers: a retrospective study on behalf of the PGL.EVA investigators*

    Gravel, Guillaume; Hernigou, Anne; Niccoli, Patricia; Rohmer, Vincent; Moulin, Guy; Borson-Chazot, Francoise; Rousset, Pascal; Pasco-Papon, Anne; Marcus, Claude; Dubrulle, Frederique; Gouya, Herve; Bidault, Francois; Dupas, Benoit; Gabrillargues, Jean; Caumont-Prim, Aurore; Gimenez-Roqueplo, Anne-Paule; Halimi, Philippe

    2016-01-01

    To assess the performance of a simplified MRI protocol consisting of a contrast-enhanced three-dimensional MR angiography (CE-MRA) in association with a post-contrast T1-weighted sequence (T1WIV) for the detection of HNPGLs in SDHx mutation carriers. This retrospective sub-study is based on the multicenter PGL.EVA cohort, which prospectively enrolled SDHx mutation carriers from 2005 to 2009; 157 index cases or relatives were included. CE-MRA and the T1WIV images were read solely with knowledge of the clinical data but blind to the diagnosis. Sensitivity, specificity and likelihood ratios for the simplified MRI protocol were compared to the full MRI protocol reading results and to the gold standard status obtained through the consensus of an expert committee. The sensitivity and specificity of the readings of the simplified MRI protocol were, respectively, 88.7 % (95 % CI = 78.1-95.3) and 93.7 % (95 % CI = 86.8-97.7) versus 80.7 % (95 % CI = 68.6-89.6) and 94.7 % (95 % CI = 88.1-98.3) for the readings of the full MRI protocol. The simplified post-contrast MRI with shorter duration (5 to 10 minutes) showed no performance difference compared to the lengthy standard full MRI and can be proposed for the detection of head and neck paragangliomas (HNPGLs) in SDHx mutation carriers. (orig.)

  15. A qualitative assessment of cross-cultural adaptation of intermediate measures for schizophrenia in multisite international studies.

    Gonzalez, Jodi M; Rubin, Maureen; Fredrick, Megan M; Velligan, Dawn I

    2013-04-30

    In this substudy of the Measurement and Treatment Research to Improve Cognition in Schizophrenia we examined qualitative feedback on the cross-cultural adaptability of four intermediate measures of functional outcome (Independent Living Scales, UCSD Performance-Based Skills Assessment, Test of Adaptive Behavior in Schizophrenia, and Cognitive Assessment Interview). Feedback was provided by experienced English-fluent clinical researchers at 31 sites in eight countries familiar with medication trials. Researchers provided feedback on test subscales and items which were rated as having adaptation challenges. They noted the specific concern and made suggestions for adaptation to their culture. We analyzed the qualitative data using a modified Grounded Theory approach guided by the International Testing Commission Guidelines model for test adaptation. For each measure except the Cognitive Assessment Interview (CAI), the majority of subscales were reported to require major adaptations in terms of content and concepts contained in the subscale. In particular, social, financial, transportation and health care systems varied widely across countries-systems which are often used to assess performance capacity in the U.S. We provide suggestions for how to address future international test development and adaptation. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  16. Clinical value of circulating endothelial cell levels in metastatic colorectal cancer patients treated with first-line chemotherapy and bevacizumab.

    Malka, D; Boige, V; Jacques, N; Vimond, N; Adenis, A; Boucher, E; Pierga, J Y; Conroy, T; Chauffert, B; François, E; Guichard, P; Galais, M P; Cvitkovic, F; Ducreux, M; Farace, F

    2012-04-01

    We investigated whether circulating endothelial cells (CECs) predict clinical outcome of first-line chemotherapy and bevacizumab in metastatic colorectal cancer (mCRC) patients. In a substudy of the randomized phase II FNCLCC ACCORD 13/0503 trial, CECs (CD45- CD31+ CD146+ 7-amino-actinomycin- cells) were enumerated in 99 patients by four-color flow cytometry at baseline and after one cycle of treatment. We correlated CEC levels with objective response rate (ORR), 6-month progression-free survival (PFS) rate (primary end point of the trial), PFS, and overall survival (OS). Multivariate analyses of potential prognostic factors, including CEC counts and Köhne score, were carried out. By multivariate analysis, high baseline CEC levels were the only independent prognostic factor for 6-month PFS rate (P < 0.01) and were independently associated with worse PFS (P = 0.02). High CEC levels after one cycle were the only independent prognostic factor for ORR (P = 0.03). High CEC levels at both time points independently predicted worse ORR (P = 0.025), 6-month PFS rate (P = 0.007), and PFS (P = 0.02). Köhne score was the only variable associated with OS. CEC levels at baseline and after one treatment cycle may independently predict ORR and PFS in mCRC patients starting first-line bevacizumab and chemotherapy.

  17. Mediterranean-style diet effect on the structural properties of the erythrocyte cell membrane of hypertensive patients: the Prevencion con Dieta Mediterranea Study.

    Barceló, Francisca; Perona, Javier S; Prades, Jesús; Funari, Sérgio S; Gomez-Gracia, Enrique; Conde, Manuel; Estruch, Ramon; Ruiz-Gutiérrez, Valentina

    2009-11-01

    A currently ongoing randomized trial has revealed that the Mediterranean diet, rich in virgin olive oil or nuts, reduces systolic blood pressure in high-risk cardiovascular patients. Here, we present a structural substudy to assess the effect of a Mediterranean-style diet supplemented with nuts or virgin olive oil on erythrocyte membrane properties in 36 hypertensive participants after 1 year of intervention. Erythrocyte membrane lipid composition, structural properties of reconstituted erythrocyte membranes, and serum concentrations of inflammatory markers are reported. After the intervention, the membrane cholesterol content decreased, whereas that of phospholipids increased in all of the dietary groups; the diminishing cholesterol:phospholipid ratio could be associated with an increase in the membrane fluidity. Moreover, reconstituted membranes from the nuts and virgin olive oil groups showed a higher propensity to form a nonlamellar inverted hexagonal phase structure that was related to an increase in phosphatidylethanolamine lipid class. These data suggest that the Mediterranean-style diet affects the lipid metabolism that is altered in hypertensive patients, influencing the structural membrane properties. The erythrocyte membrane modulation described provides insight in the structural bases underlying the beneficial effect of a Mediterranean-style diet in hypertensive subjects.

  18. Individual Participant Data Meta-Analysis of Mechanical Workplace Risk Factors and Low Back Pain

    Shannon, Harry S.; Wells, Richard P.; Walter, Stephen D.; Cole, Donald C.; Côté, Pierre; Frank, John; Hogg-Johnson, Sheilah; Langlois, Lacey E.

    2012-01-01

    Objectives. We used individual participant data from multiple studies to conduct a comprehensive meta-analysis of mechanical exposures in the workplace and low back pain. Methods. We conducted a systematic literature search and contacted an author of each study to request their individual participant data. Because outcome definitions and exposure measures were not uniform across studies, we conducted 2 substudies: (1) to identify sets of outcome definitions that could be combined in a meta-analysis and (2) to develop methods to translate mechanical exposure onto a common metric. We used generalized estimating equation regression to analyze the data. Results. The odds ratios (ORs) for posture exposures ranged from 1.1 to 2.0. Force exposure ORs ranged from 1.4 to 2.1. The magnitudes of the ORs differed according to the definition of low back pain, and heterogeneity was associated with both study-level and individual-level characteristics. Conclusions. We found small to moderate ORs for the association of mechanical exposures and low back pain, although the relationships were complex. The presence of individual-level OR modifiers in such an area can be best understood by conducting a meta-analysis of individual participant data. PMID:22390445

  19. Treatment of HIV infection with a raltegravir-based regimen increases LDL levels, but improves HDL cholesterol efflux capacity.

    Funderburg, Nicholas T; Xu, Dihua; Playford, Martin P; Joshi, Aditya A; Andrade, Adriana; Kuritzkes, Daniel R; Lederman, Michael M; Mehta, Nehal N

    2017-01-01

    Persons infected with HIV often have altered lipid profiles that may be affected by antiretroviral therapies (ART). Traditional lipid measurements may be insufficient to assess cardiovascular disease (CVD) risk in this population. We report results from 39 ART-naive participants in a substudy of A5248, a single-arm study of raltegravir, emtricitabine/tenofovir administration. Samples were collected at baseline, 12, 24 and 48 weeks after ART initiation. We performed advanced lipid phenotyping using nuclear magnetic resonance spectroscopy (Liposcience, Raleigh, NC, USA) for lipid particle size and number, and examined high-density lipoprotein (HDL) function measuring reverse cholesterol transport using J774 macrophages. We report significant increases in total cholesterol (13 mg/dl; PLDL; 8 mg/dl; P=0.03), with no change in triglycerides and without an increase in LDL particle number (P>0.1 all time points). HDL levels were increased over baseline levels at all time points (PLDL (oxLDL) levels decreased by week 12, but rose subsequently, and were not different from baseline at later time points. HDL increases were associated with increases in beneficial HDL particles and HDL cholesterol efflux capacity, which may reduce future CVD events. Persistent inflammation in these HIV+ participants, may be a cause or consequence of oxLDL levels, and may contribute to declining levels of HDL over time. Clinicaltrials.gov NCT00660972.

  20. Repeatability and response to therapy of dynamic contrast-enhanced magnetic resonance imaging biomarkers in rheumatoid arthritis in a large multicentre trial setting

    Waterton, John C. [University of Manchester, Stopford Building, Manchester Academic Health Sciences Centre, Manchester (United Kingdom); Personalised Healthcare and Biomarkers, AstraZeneca, Macclesfield (United Kingdom); Ho, Meilien [AstraZeneca, Global Medicines Development, Macclesfield (United Kingdom); Nordenmark, Lars H. [AstraZeneca, Global Medicines Development, Moelndal (Sweden); Jenkins, Martin [AstraZeneca, Global Medicines Development, Cambridge (United Kingdom); DiCarlo, Julie; Peterfy, Charles [Spire Sciences Inc, Boca Raton, FL (United States); Guillard, Gwenael; Bowes, Michael A. [Imorphics, Manchester (United Kingdom); Roberts, Caleb; Buonaccorsi, Giovanni [Bioxydyn, Manchester (United Kingdom); Parker, Geoffrey J.M. [University of Manchester, Stopford Building, Manchester Academic Health Sciences Centre, Manchester (United Kingdom); Bioxydyn, Manchester (United Kingdom); Kellner, Herbert [Private Practice and Division of Rheumatology KHI Neuwittelsbach, Muenchen (Germany); Taylor, Peter C. [University of Oxford, Kennedy Institute, Oxford (United Kingdom)

    2017-09-15

    To determine the repeatability and response to therapy of dynamic contrast-enhanced (DCE) MRI biomarkers of synovitis in the hand and wrist of rheumatoid arthritis (RA) patients, and in particular the performance of the transfer constant K{sup trans}, in a multicentre trial setting. DCE-MRI and RA MRI scoring (RAMRIS) were performed with meticulous standardisation at baseline and 6 and 24 weeks in a substudy of fostamatinib monotherapy in reducing synovitis compared with placebo or adalimumab. Analysis employed statistical shape modelling to avoid biased regions-of-interest, kinetic modelling and heuristic analyses. Repeatability was also evaluated. At early study termination, DCE-MRI data had been acquired from 58 patients in 19 imaging centres. K{sup trans} intra-subject coefficient of variation (N = 14) was 30%. K{sup trans} change demonstrated inferiority of fostamatinib (N = 11) relative to adalimumab (N = 10) after 6 weeks (treatment ratio = 1.92, p = 0.003), and failed to distinguish fostamatinib from placebo (N = 10, p = 0.79). RAMRIS showed superiority of fostamatinib relative to placebo at 6 weeks (p = 0.023), and did not distinguish fostamatinib from adalimumab at either 6 (p = 0.175) or 24 (p = 0.230) weeks. This demonstrated repeatability of K{sup trans} and its ability to distinguish treatment groups show that DCE-MRI biomarkers are suitable for use in multicentre RA trials. (orig.)

  1. Accuracy and reading time for six strategies using digital breast tomosynthesis in women with mammographically negative dense breasts.

    Tagliafico, Alberto Stefano; Calabrese, Massimo; Bignotti, Bianca; Signori, Alessio; Fisci, Erica; Rossi, Federica; Valdora, Francesca; Houssami, Nehmat

    2017-12-01

    To compare six strategies using digital breast tomosynthesis in women with mammographically negative dense breasts. This is a substudy of the 'ASTOUND' trial. 163 women who underwent tomosynthesis with synthetically reconstructed projection images (S-2D) inclusive of 13 (7.9%) cases diagnosed with breast cancer at histopathology after surgery were evaluated. Accuracy measures and screen-reading time of six reading strategies were assessed: (A) Single reading of S-2D alone, (B) single reading of tomosynthesis alone, (C) single reading of joint interpretation of tomosynthesis + S-2D, (D) double-reading of S-2D alone, (E) double reading of tomosynthesis alone, (F) double reading of joint interpretation of tomosynthesis + S-2D. The median age of the patients was 53 years (range, 36-88 years). The highest global accuracy was obtained with double reading of tomosynthesis + S2D (F) with an AUC of 0.979 (ptomosynthesis+ S2D had the best accuracy of six screen-reading strategies although it had the longest reading time. • Tomosynthesis acquisitions are progressively implemented with reconstructed synthesized 2D images • Double reading using S-2D plus tomosynthesis had the highest global accuracy (ptomosynthesis increased reading time.

  2. SecureMA: protecting participant privacy in genetic association meta-analysis.

    Xie, Wei; Kantarcioglu, Murat; Bush, William S; Crawford, Dana; Denny, Joshua C; Heatherly, Raymond; Malin, Bradley A

    2014-12-01

    Sharing genomic data is crucial to support scientific investigation such as genome-wide association studies. However, recent investigations suggest the privacy of the individual participants in these studies can be compromised, leading to serious concerns and consequences, such as overly restricted access to data. We introduce a novel cryptographic strategy to securely perform meta-analysis for genetic association studies in large consortia. Our methodology is useful for supporting joint studies among disparate data sites, where privacy or confidentiality is of concern. We validate our method using three multisite association studies. Our research shows that genetic associations can be analyzed efficiently and accurately across substudy sites, without leaking information on individual participants and site-level association summaries. Our software for secure meta-analysis of genetic association studies, SecureMA, is publicly available at http://github.com/XieConnect/SecureMA. Our customized secure computation framework is also publicly available at http://github.com/XieConnect/CircuitService. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  3. Impact assessment and mitigation in existing lake regulation projects in the Oulujoki river system

    Kaatra, K.; Marttunen, M.

    1993-01-01

    The objective of the project was to determine how regulation practices and shore zone maintenance and improvement should be developed in order to give more attention to recreational requirements and factors affecting the aquatic environment. The proposals must not, however, cause flooding damage or significant energy economy losses. The effects of four alternative regulation practices on hydrology flooding damage, recreational utilization, the aquatic, environment, fisheries and the hydropower production were compared in lakes Oulujaervi, Kiantajaervi, Vuokkijaervi, Ontojaervi and Sotkamonjaervi. An extensive sub-study was made on the maintenance and improvement of the shore zones of the regulated lakes. Ways of reducing excessive vegetation were studied in Lake Oulujaervi, and experiments testing the feasibility of various plants in protecting and landscaping the littoral zone were conducted in Lake Ontojaervi. Enquiries in to the perceptions of and the needs for mitigating harmful impacts, as experienced by the people living within the area affected by the river development projects, were also included in the analysis. The alternative regulation practices for Lake Oulujaervi were compared using the decision analysis interview method, in which the data acquired through the environmental impact analysis of effects were combined with the values of the local people and interest groups. The impact of alternative regulation practices was also weighed from the viewpoint of sustainability in various scales. Recommendations were made for regulation patterns and maintenance and improvement programmes for individual lakes

  4. N-terminal pro-brain natriuretic peptide and abnormal brain aging: The AGES-Reykjavik Study.

    Sabayan, Behnam; van Buchem, Mark A; de Craen, Anton J M; Sigurdsson, Sigurdur; Zhang, Qian; Harris, Tamara B; Gudnason, Vilmundur; Arai, Andrew E; Launer, Lenore J

    2015-09-01

    To investigate the independent association of serum N-terminal fragment of the prohormone natriuretic peptide (NT-proBNP) with structural and functional features of abnormal brain aging in older individuals. In this cross-sectional study based on the Age, Gene/Environment Susceptibility (AGES)-Reykjavik Study, we included 4,029 older community-dwelling individuals (born 1907 to 1935) with a measured serum level of NT-proBNP. Outcomes included parenchymal brain volumes estimated from brain MRI, cognitive function measured by tests of memory, processing speed, and executive functioning, and presence of depressive symptoms measured using the Geriatric Depression Scale. In a substudy, cardiac output of 857 participants was assessed using cardiac MRI. In multivariate analyses, adjusted for sociodemographic and cardiovascular factors, higher levels of NT-proBNP were independently associated with lower total (p brain volumes. Likewise, in multivariate analyses, higher levels of NT-proBNP were associated with worse scores in memory (p = 0.005), processing speed (p = 0.001), executive functioning (p brain parenchymal volumes, impaired executive function and processing speed, and higher depressive symptoms were independent of the level of cardiac output. Higher serum levels of NT-proBNP, independent of cardiovascular risk factors and a measure of cardiac function, are linked with alterations in brain structure and function. Roles of natriuretic peptides in the process of brain aging need to be further elucidated. © 2015 American Academy of Neurology.

  5. Using Qualitative Methods to Understand Physical Activity and Weight Management Among Bangladeshis in New York City, 2013.

    Riley, Lindsey; Mili, Saima; Trinh-Shevrin, Chau; Islam, Nadia

    2016-07-07

    South Asians experience high rates of cardiovascular disease and type 2 diabetes, coupled with low rates of reported physical activity. We report findings from a qualitative sub-study that was conducted in 2013 among Bangladeshi immigrants in New York City to understand factors that affect physical activity practices and weight management in this community. Qualitative study participants were recruited from community-based settings. Sex-specific focus groups were conducted by trained community health workers. Proceedings were audio-recorded for translation and transcription and coded using a constant comparative approach. Data were coded using Atlas.ti software. Six focus groups were completed with a final sample of 67 participants (63% male, 37% female). Mean participant age was 42 years; mean years of residence in the United States was 12. Key themes that emerged were beliefs about modesty and sex-separated facilities that may prevent women from engaging in physical activity. Distinctions were made between men and women about what constitutes exercise versus physical activity; religious prayer was considered to be health-promoting because of the movement involved. Other important themes that emerged were cultural dietary practices and evolving conceptions of healthy weight. Tailored interventions that take into account the cultural context of this growing community are needed. Findings may also provide insight into barriers to health promotion experienced by other US Muslim communities, which are growing rapidly.

  6. Circulating Angiogenic Cell Function is Inhibited by Cortisol in Vitro and Associated with Psychological Stress and Cortisol in Vivo

    Aschbacher, Kirstin; Derakhshandeh, Ronak; Flores, Abdiel J.; Narayan, Shilpa; Mendes, Wendy Berry; Springer, Matthew L.

    2016-01-01

    Psychological stress and glucocorticoids are associated with heightened cardiovascular disease risk. We investigated whether stress or cortisol would be associated with reduced circulating angiogenic cell (CAC) function, an index of impaired vascular repair. We hypothesized that minority-race individuals who experience threat in interracial interactions would exhibit reduced CAC function, and that this link might be explained by cortisol. To test this experimentally, we recruited 106 African American participants for a laboratory interracial interaction task, in which they received socially evaluative feedback from Caucasian confederates. On a separate day, a subset of 32 participants (mean age = 26 years, 47% female) enrolled in a separate biological substudy and provided blood samples for CAC isolation and salivary samples to quantify the morning peak in cortisol (the cortisol awakening response, CAR). CAC function was quantified using cell culture assays of migration to vascular endothelial growth factor (VEGF) and secretion of VEGF into the culture medium. Heightened threat in response to an interracial interaction and trait anxiety in vivo were both associated with poorer CAC migratory function in vitro. Further, threat and poorer sustained attention during the interracial interaction were associated with a higher CAR, which in turn, was related to lower CAC sensitivity to glucocorticoids. In vitro, higher doses of cortisol impaired CAC migratory function and VEGF protein secretion. The glucocorticoid receptor antagonist RU486 reversed this functional impairment. These data identify a novel, neuroendocrine pathway by which psychological stress may reduce CAC function, with potential implications for cardiovascular health. PMID:26925833

  7. Insomnia symptoms and behavioural health symptoms in veterans 1 year after traumatic brain injury.

    Farrell-Carnahan, Leah; Barnett, Scott; Lamberty, Gregory; Hammond, Flora M; Kretzmer, Tracy S; Franke, Laura M; Geiss, Meghan; Howe, Laura; Nakase-Richardson, Risa

    2015-01-01

    Insomnia and behavioural health symptoms 1 year after traumatic brain injury (TBI) were examined in a clinical sample representative of veterans who received inpatient treatment for TBI-related issues within the Veterans Health Administration. This was a cross-sectional sub-study (n = 112) of the Polytrauma Rehabilitation Centres' traumatic brain injury model system programme. Prevalence estimates of insomnia, depression, general anxiety, nightmares, headache and substance use, stratified by injury severity, were derived. Univariate logistic regression was used to examine unadjusted effects for each behavioural health problem and insomnia by injury severity. Participants were primarily male, insomnia; those with mild TBI were significantly more likely to meet criteria (43%) than those with moderate/severe TBI (22%), χ(2)(1, n = 112) = 5.088, p ≤ 0.05. Univariable logistic regression analyses revealed depressive symptoms and general anxiety were significantly associated with insomnia symptoms after TBI of any severity. Headache and binge drinking were significantly inversely related to insomnia symptoms after moderate/severe TBI, but not MTBI. Veterans with history of TBI, of any severity, and current insomnia symptoms may be at increased risk for depression and anxiety 1 year after TBI.

  8. Does mass azithromycin distribution impact child growth and nutrition in Niger? A cluster-randomized trial.

    Abdou Amza

    2014-09-01

    Full Text Available Antibiotic use on animals demonstrates improved growth regardless of whether or not there is clinical evidence of infectious disease. Antibiotics used for trachoma control may play an unintended benefit of improving child growth.In this sub-study of a larger randomized controlled trial, we assess anthropometry of pre-school children in a community-randomized trial of mass oral azithromycin distributions for trachoma in Niger. We measured height, weight, and mid-upper arm circumference (MUAC in 12 communities randomized to receive annual mass azithromycin treatment of everyone versus 12 communities randomized to receive biannual mass azithromycin treatments for children, 3 years after the initial mass treatment. We collected measurements in 1,034 children aged 6-60 months of age.We found no difference in the prevalence of wasting among children in the 12 annually treated communities that received three mass azithromycin distributions compared to the 12 biannually treated communities that received six mass azithromycin distributions (odds ratio = 0.88, 95% confidence interval = 0.53 to 1.49.We were unable to demonstrate a statistically significant difference in stunting, underweight, and low MUAC of pre-school children in communities randomized to annual mass azithromycin treatment or biannual mass azithromycin treatment. The role of antibiotics on child growth and nutrition remains unclear, but larger studies and longitudinal trials may help determine any association.

  9. Gender differences in the utilisation of surgery for congenital heart disease in India.

    Ramakrishnan, Sivasubramanian; Khera, Rohan; Jain, Snigdha; Saxena, Anita; Kailash, Suparna; Karthikeyan, Ganesan; Kothari, Shyam S; Juneja, Rajnish; Bhargava, Balram; Kalaivani, Mani; Mehta, Manju; Bahl, Vinay K; Airan, Balram

    2011-12-01

    Corrective surgery for congenital heart disease may be life-saving, but its utilisation depends upon several social and economic factors. Girls with cardiac defects may not receive equitable care in India, but this has not been systematically studied. In this prospective study, parents or guardians of 405 consecutive children aged up to 12 years (mean ± SD age 3.43 ± 3.44 years; 271 boys) who had been advised to undergo elective paediatric cardiac surgery were interviewed using a validated questionnaire. The status of the patients was reviewed after a year and the factors associated with non-compliance with treatment were analysed. In a qualitative sub-study the parents of 20 children who had not undergone surgery were interviewed. Qualitative data were analysed using an inductive analytical approach. Of the 405 patients studied, 44% (59/134) of girls had undergone surgery at 1 year compared with 70% (189/271) of boys (χ²=24.97; pmatrimonial prospects of girls and lack of social support emerged as the major factors responsible for delays in undergoing surgery. Female gender is an important determinant of non-compliance with paediatric cardiac surgery. Deep-seated social factors underlie this gender bias.

  10. Comparison of monoclonal and polyclonal ELISAs for fecal elastase in patients with cystic fibrosis and pancreatic insufficiency.

    Borowitz, Drucy; Lin, Rong; Baker, Susan S

    2007-02-01

    Two enzyme-linked immunosorbent assay methodologies are used to detect pancreatic insufficiency: monoclonal and polyclonal. We sought to compare these assays in patients with cystic fibrosis and to correlate these with the coefficient of fat absorption (CFA). As part of a larger study, subjects had stool elastase measured by both methods while taking exogenous enzymes. Subjects subsequently stopped enzymes and had a fecal fat balance study performed; the CFA was then calculated. One hundred twenty-four subjects participated in this substudy. The median values for the monoclonal and polyclonal assays were 0.3 and 22.75 microg/g, respectively. The correlation coefficient between the 2 tests was 0.86 (P definition of pancreatic insufficiency was set at a CFA definition of pancreatic insufficiency was set at <100 microg/g, then the monoclonal and polyclonal assay positive predictive values were 97.6% (120 of 123) and 97.4% (111 of 114), respectively. The positive predictive value of both monoclonal and polyclonal fecal elastase in patients with cystic fibrosis is extremely good; however, correlation of either test with CFA was poor. The median value for the polyclonal elastase assay is higher than for the monoclonal assay, which could potentially lead to lower sensitivity of the polyclonal assay at lower cutpoints for the monoclonal assay is used.

  11. Variants of PLCXD3 are not associated with variant or sporadic Creutzfeldt-Jakob disease in a large international study.

    Balendra, Rubika; Uphill, James; Collinson, Claire; Druyeh, Ronald; Adamson, Gary; Hummerich, Holger; Zerr, Inga; Gambetti, Pierluigi; Collinge, John; Mead, Simon

    2016-04-07

    Human prion diseases are relentlessly progressive neurodegenerative disorders which include sporadic Creutzfeldt-Jakob disease (sCJD) and variant CJD (vCJD). Aside from variants of the prion protein gene (PRNP) replicated association at genome-wide levels of significance has proven elusive. A recent association study identified variants in or near to the PLCXD3 gene locus as strong disease risk factors in multiple human prion diseases. This study claimed the first non-PRNP locus to be highly significantly associated with prion disease in genomic studies. A sub-study of a genome-wide association study with imputation aiming to replicate the finding at PLCXD3 including 129 vCJD and 2500 sCJD samples. Whole exome sequencing to identify rare coding variants of PLCXD3. Imputation of relevant polymorphisms was accurate based on wet genotyping of a sample. We found no supportive evidence that PLCXD3 variants are associated with disease. The marked discordance in vCJD genotype frequencies between studies, despite extensive overlap in vCJD cases, and the finding of Hardy-Weinberg disequilibrium in the original study, suggests possible reasons for the discrepancies between studies.

  12. Sense of competence in dementia care staff (SCIDS) scale: development, reliability, and validity.

    Schepers, Astrid Kristine; Orrell, Martin; Shanahan, Niamh; Spector, Aimee

    2012-07-01

    Sense of competence in dementia care staff (SCIDS) may be associated with more positive attitudes to dementia among care staff and better outcomes for those being cared for. There is a need for a reliable and valid measure of sense of competence specific to dementia care staff. This study describes the development and evaluation of a measure to assess "sense of competence" in dementia care staff and reports on its psychometric properties. The systematic measure development process involved care staff and experts. For item selection and assessment of psychometric properties, a pilot study (N = 37) and a large-scale study (N = 211) with a test-retest reliability (N = 58) sub-study were undertaken. The final measure consists of 17 items across four subscales with acceptable to good internal consistency and moderate to substantial test-retest reliability. As predicted, the measure was positively associated with work experience, job satisfaction, and person-centered approaches to dementia care, giving a first indication for its validity. The SCIDS scale provides a useful and user-friendly means of measuring sense of competence in care staff. It has been developed using a robust process and has adequate psychometric properties. Further exploration of the construct and the scale's validity is warranted. It may be useful to assess the impact of training and perceived abilities and skills in dementia care.

  13. Change in quality of life and immune markers after a stay at a raw vegan institute: a pilot study.

    Link, Lilli B; Hussaini, Najeeb S; Jacobson, Judith S

    2008-06-01

    The purpose of this study was to explore changes in quality of life (QOL), anxiety, stress, and immune markers after a stay at a raw vegan institute. Prospective observational study. English-speaking attendees at Hippocrates Health Institute (Florida, US), a raw vegan institute, were recruited on arrival and typically stayed 1-3 weeks. Participants completed questionnaires assessing overall QOL (SF-36), dietary QOL (QOL related to dietary change), perceived stress (Perceived Stress Scale), anxiety, and depression (Hospital Anxiety and Depression Scale) upon arrival and 12 weeks later. C-reactive protein (CRP), lymphocytes, T cells, CD4 cells, CD8 cells, B cells, and NK cells were measured at baseline and 12 weeks in participants living in North America. Of 107 attendees eligible for the questionnaire study and 82 for the blood marker substudy, 51 and 38 participants, respectively, provided complete follow-up data. Overall QOL improved 11.5% (p=0.001), driven mostly by the mental component. Anxiety decreased 18.6% (p=0.009) and perceived stress decreased 16.4% (pvegan institute was associated with improved mental and emotional QOL. Studies are needed to determine the feasibility of conducting a clinical trial of the raw vegan diet among healthy people, and subsequently among patients with specific diseases.

  14. The contribution of demographic and morbidity factors to self-reported visit frequency of patients: a cross-sectional study of general practice patients in Australia

    Britt Helena

    2004-08-01

    Full Text Available Abstract Background Understanding the factors that affect patients' utilisation of health services is important for health service provision and effective patient management. This study aimed to investigate the specific morbidity and demographic factors related to the frequency with which general practice patients visit a general practitioner/family physician (GP in Australia. Methods A sub-study was undertaken as part of an ongoing national study of general practice activity in Australia. A cluster sample of 10,755 general practice patients were surveyed through a random sample of 379 general practitioners. The patient reported the number of times he/she had visited a general practitioner in the previous twelve months. The GP recorded all the patient's major health problems, including those managed at the current consultation. Results Patients reported an average of 8.8 visits to a general practitioner per year. After adjusting for other patient demographics and number of health problems, concession health care card holders made on average 2.6 more visits per year to a general practitioner than did non-card holders (p Conclusions Anxiety, back pain and depression are associated with greater patient demand for general practice services than other health problems. The effect of sociodemographic factors on patient utilisation of general practice services is complex. Equity of access to general practice services remains an issue for patients from remote areas, while concession health care card holders are attending general practice more frequently than other patients relative to their number of health problems.

  15. A qualitative study of patient motivation to adhere to combination antiretroviral therapy in South Africa.

    van Loggerenberg, Francois; Gray, Debra; Gengiah, Santhanalakshmi; Kunene, Pinky; Gengiah, Tanuja N; Naidoo, Kogieleum; Grant, Alison D

    2015-05-01

    Taken as prescribed, that is, with high adherence, combination antiretroviral therapy (ART) has changed HIV infection and disease from being a sure predictor of death to a manageable chronic illness. Adherence, however, is difficult to achieve and maintain. The CAPRISA 058 study was conducted between 2007 and 2009 to test the efficacy of individualized motivational counselling to enhance ART adherence in South Africa. As part of the overall trial, a qualitative sub-study was conducted, including 30 individual interviews and four focus group discussions with patients in the first 9 months of ART initiation. Data were inductively analyzed, using thematic analysis, to identify themes central to ART adherence in this context. Four themes emerged that characterize the participants' experiences and high motivation to adhere to ART. Participants in this study were highly motivated to adhere, as they acknowledged that ART was 'life-giving', in the face of a large amount of morbidity and mortality. They were further supported by techniques of routine remembering, and highlighted the importance of good social support and access to supportive healthcare workers, to their continued success in negotiating their treatment. Participants in the current study told us that their adherence motivation is enhanced by free accessible care, approachable and supportive healthcare workers, broad social acceptance of ART, and past first-hand experiences with AIDS-related co-morbidity and mortality. Programs that include specific attention to these aspects of care will likely be successful in the long term.

  16. Lower C-reactive protein and IL-6 associated with vegetarian diets are mediated by BMI.

    Jaceldo-Siegl, K; Haddad, E; Knutsen, S; Fan, J; Lloren, J; Bellinger, D; Fraser, G E

    2018-03-13

    The mechanism by which vegetarian diets are associated with less inflammation is not clear. We investigated the role of BMI as a mediator in the relationship between vegetarian diet and concentrations of C-reactive protein (CRP), and the cytokines IL-6, IL-10 and TNF-α. We used data from participants of the Adventist Health Study 2 (AHS-2) Calibration (n = 893) and Biological Manifestations of Religion (n = 478) sub-studies. Vegetarian diet variations were determined based on reported intake of animal products assessed by FFQ. Combining all participants, the proportion of non-vegetarians (NVs), partial vegetarians (PVs), lacto-ovo vegetarians (LOVs), and strict vegetarians (SVs) was 44%, 16%, 31%, and 9%, respectively. NV and PV participants were older than other dietary groups, and non-vegetarians had the highest BMI. Mediation analyses supported the mediating effect of BMI in associations of vegetarian diet with CRP (p vegetarian diet and the biomarkers IL-10 and TNF-α. A direct pathway was significant only in the association between strict vegetarians and CRP (p = 0.017). The lower CRP and IL-6 concentrations among vegetarians may be mediated by BMI. Copyright © 2018 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

  17. Global bike share: What the data tells us about road safety.

    Fishman, Elliot; Schepers, Paul

    2016-02-01

    Bike share has emerged as a rapidly growing mode of transport in over 800 cities globally, up from just a handful in the 1990s. Some analysts had forecast a rise in the number of bicycle crashes after the introduction of bike share, but empirical research on bike share safety is rare. The goal of this study is to examine the impact of bike share programs on cycling safety. The paper has two substudies. Study 1 was a secondary analysis of longitudinal hospital injury data from the Graves et al. (2014) study. It compared cycling safety in cities that introduced bike share programs with cities that did not. Study 2 combined ridership data with crash data of selected North American and European cities to compare bike share users to other cyclists. Study 1 indicated that the introduction of a bike share system was associated with a reduction in cycling injury risk. Study 2 found that bike share users were less likely than other cyclists to sustain fatal or severe injuries. On a per kilometer basis, bike share is associated with decreased risk of both fatal and non-fatal bicycle crashes when compared to private bike riding. The results of this study suggest that concerns of decreased levels of cycling safety are unjustified and should not prevent decision makers from introducing public bike share schemes, especially if combined with other safety measures like traffic calming. Copyright © 2015 Elsevier Ltd and National Safety Council. All rights reserved.

  18. CXC chemokine ligand 16 is increased in gestational diabetes mellitus and preeclampsia and associated with lipoproteins in gestational diabetes mellitus at 5 years follow-up.

    Lekva, Tove; Michelsen, Annika E; Aukrust, Pål; Paasche Roland, Marie Cecilie; Henriksen, Tore; Bollerslev, Jens; Ueland, Thor

    2017-11-01

    Women with a history of gestational diabetes mellitus and preeclampsia are at increased risk of cardiovascular disease later in life, but the mechanism remains unclear. The aim of the study was to evaluate the association between CXC chemokine ligand 16 and indices of glucose metabolism, dyslipidemia and systemic inflammation in gestational diabetes mellitus and preeclampsia. This sub-study of the population-based prospective cohort included 310 women. Oral glucose tolerance test was performed during pregnancy and 5 years later along with lipid analysis. CXC chemokine ligand 16 was measured in plasma (protein) and peripheral blood mononuclear cells (messenger RNA) during pregnancy and at follow-up. Circulating CXC chemokine ligand 16 was higher in gestational diabetes mellitus women early in pregnancy and at follow-up, while higher in preeclampsia women late in pregnancy compared to control women. Messenger RNA of CXC chemokine ligand 16 in peripheral blood mononuclear cells were lower in gestational diabetes mellitus and preeclampsia women compared to control women. Increased circulating CXC chemokine ligand 16 level was associated with a higher apolipoprotein B and low-density lipoprotein cholesterol in gestational diabetes mellitus women but not in normal pregnancy at follow-up. Our study shows that women with gestational diabetes mellitus and preeclampsia had a dysregulated CXC chemokine ligand 16 during pregnancy, and in gestational diabetes mellitus, the increase in CXC chemokine ligand 16 early in pregnancy and after 5 years was strongly associated with their lipid profile.

  19. ABCC-JNIH Adult Health Study, Hiroshima 1958-1960. Cardiovascular Project Report 3. Prevalence of cardiovascular diseases related to associated factors

    Ueda, Shoichi; Yano, Katsuhiko

    1962-12-12

    A long-term follow-up investigation of cardiovascular disease was organized primarily as an intensive substudy of the ABCC-JNIH Adult Health Study and secondarily for epidemiologic comparison with data on the Framingham, Massachusetts, population. One of the purposes of the present cardiovascular studies on a Hiroshima population was to obtain data comparable with that of the Framingham Study. An equally important aspect of the Hiroshima study is to explore radiation effects on the cardiovascular system. The sample is the Adult Health Study population and consists of 13,000 males and females in Hiroshima. This report provides the prevalence of cardiovascular disease in the first cross-section examined during 1958-1960 together with certain information on related factors. The overall attrition rate was 25%; 15% was caused by death or migration before the examination and 10% by refusal to participate. No significant difference was found in the blood pressure levels between the nonrespondents and the respondents in comparison with results of prior examinations at ABCC. The prevalence of various cardiovascular diseases was analyzed by sex and age. The analysis also extended to relationship of blood pressure, serum cholesterol, body weight, heart size, and occupation, with the prevalence of coronary heart disease for the sample over 40 years of age. 12 references, 15 tables.

  20. Mild parkinsonian signs in the elderly--is there an association with PD? Crossectional findings in 992 individuals.

    Stefanie Lerche

    Full Text Available Mild parkinsonian signs (MPS are common in the elderly population, and have been associated with vascular diseases, mild cognitive impairment and dementia; however their relation to Parkinson's disease (PD is unclear. Hypothesizing that individuals with MPS may reflect a pre-stage of PD, i.e. a stage in which the nigrostriatal system is already affected although to a milder degree than at the time of PD diagnosis, aim of this study was to evaluate the similarities between MPS and PD.The TREND study is a prospective cross-sectional cohort study in individuals >50 years with biennial assessments designed to identify markers for an earlier diagnosis of Parkinson's and Alzheimer's disease. For this substudy 992 individuals were included for analyses (892 controls, 73 MPS individuals, 27 PD patients. Parameters defining risk of PD (sex, age, positive family history, prodromal markers (hyposmia, REM sleep behavior disorder, depression and autonomic failure as well as quantitative fine motor, axial motor and cognitive parameters were compared between the three cohorts.As expected, PD patients differed from controls with regard to 12 of 15 of the assessed parameters. MPS individuals differed significantly from controls in 12 of the PD-associated parameters, but differed from PD only in 5 parameters.This study shows that individuals with MPS share many prodromal and clinical markers of PD with PD patients, implying that either a common dynamic process or similar constitutional factors occur in MPS individuals and PD patients.

  1. Interaction of Body Mass Index on the Association Between N-Terminal-Pro-b-Type Natriuretic Peptide and Morbidity and Mortality in Patients With Acute Heart Failure: Findings From ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure).

    Bhatt, Ankeet S; Cooper, Lauren B; Ambrosy, Andrew P; Clare, Robert M; Coles, Adrian; Joyce, Emer; Krishnamoorthy, Arun; Butler, Javed; Felker, G Michael; Ezekowitz, Justin A; Armstrong, Paul W; Hernandez, Adrian F; O'Connor, Christopher M; Mentz, Robert J

    2018-02-03

    Higher body mass index (BMI) is associated with lower circulating levels of N-terminal-pro-b-type natriuretic peptide (NT-proBNP). The Interaction between BMI and NT-proBNP with respect to clinical outcomes is not well characterized in patients with acute heart failure. A total of 686 patients from the biomarker substudy of the ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated HF ) clinical trial with documented NT-proBNP levels at baseline were included in the present analysis. Patients were classified by the World Health Organization obesity classification (nonobese: BMI value of NT-proBNP was not modified by BMI in this acute heart failure population. NT-proBNP remains a useful prognostic indicator of long-term mortality in acute heart failure even in the obese patient. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00475852. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  2. Neighborhood socioeconomic deprivation, perceived neighborhood factors, and cortisol responses to induced stress among healthy adults.

    Barrington, Wendy E; Stafford, Mai; Hamer, Mark; Beresford, Shirley A A; Koepsell, Thomas; Steptoe, Andrew

    2014-05-01

    Associations between measures of neighborhood socioeconomic deprivation and health have been identified, yet work is needed to uncover explanatory mechanisms. One hypothesized pathway is through stress, yet the few studies that have evaluated associations between characteristics of deprived neighborhoods and biomarkers of stress are mixed. This study evaluated whether objectively measured neighborhood socioeconomic deprivation and individual perceived neighborhood characteristics (i.e. social control and fear of crime) impacted cortisol responses to an induced stressor among older healthy adults. Data from Heart Scan, a sub-study of the Whitehall II cohort, were used to generate multilevel piecewise growth-curve models of cortisol trajectories after a laboratory stressor accounting for neighborhood and demographic characteristics. Neighborhood socioeconomic deprivation was significantly associated with individual perceptions of social control and fear of crime in the neighborhood while an association with blunted cortisol reactivity was only evidence among women. Social control was significantly associated with greater cortisol reactivity and mediation between neighborhood socioeconomic deprivation and cortisol reactivity was suggested among women. These findings support a gender-dependent role of neighborhood in stress process models of health. Published by Elsevier Ltd.

  3. Physical Inactivity Predicts Slow Gait Speed in an Elderly Multi-Ethnic Cohort Study: The Northern Manhattan Study.

    Willey, Joshua Z; Moon, Yeseon P; Kulick, Erin R; Cheung, Ying Kuen; Wright, Clinton B; Sacco, Ralph L; Elkind, Mitchell S V

    2017-01-01

    Gait speed is associated with multiple adverse outcomes of aging. We hypothesized that physical inactivity would be prospectively inversely associated with gait speed independently of white matter hyperintensity volume and silent brain infarcts on MRI. Participants in the Northern Manhattan Study MRI sub-study had physical activity assessed when they were enrolled into the study. A mean of 5 years after the MRI, participants had gait speed measured via a timed 5-meter walk test. Physical inactivity was defined as reporting no leisure-time physical activity. Multi-variable logistic and quantile regression was performed to examine the associations between physical inactivity and future gait speed adjusted for confounders. Among 711 participants with MRI and gait speed measures (62% women, 71% Hispanic, mean age 74.1 ± 8.4), the mean gait speed was 1.02 ± 0.26 m/s. Physical inactivity was associated with a greater odds of gait speed in the lowest quartile (Physical inactivity is associated with slower gait speed independently of osteoarthritis, grip strength, and subclinical ischemic brain injury. Modifying sedentary behavior poses a target for interventions aimed at reducing decline in mobility. © 2017 S. Karger AG, Basel.

  4. Improving hypertension management through pharmacist prescribing; the rural alberta clinical trial in optimizing hypertension (Rural RxACTION: trial design and methods

    Campbell Norman RC

    2011-08-01

    Full Text Available Abstract Background Patients with hypertension continue to have less than optimal blood pressure control, with nearly one in five Canadian adults having hypertension. Pharmacist prescribing is gaining favor as a potential clinically efficacious and cost-effective means to improve both access and quality of care. With Alberta being the first province in Canada to have independent prescribing by pharmacists, it offers a unique opportunity to evaluate outcomes in patients who are prescribed antihypertensive therapy by pharmacists. Methods The study is a randomized controlled trial of enhanced pharmacist care, with the unit of randomization being the patient. Participants will be randomized to enhanced pharmacist care (patient identification, assessment, education, close follow-up, and prescribing/titration of antihypertensive medications or usual care. Participants are patients in rural Alberta with undiagnosed/uncontrolled blood pressure, as defined by the Canadian Hypertension Education Program. The primary outcome is the change in systolic blood pressure between baseline and 24 weeks in the enhanced-care versus usual-care arms. There are also three substudies running in conjunction with the project examining different remuneration models, investigating patient knowledge, and assessing health-resource utilization amongst patients in each group. Discussion To date, one-third of the required sample size has been recruited. There are 15 communities and 17 pharmacists actively screening, recruiting, and following patients. This study will provide high-level evidence regarding pharmacist prescribing. Trial Registration Clinicaltrials.gov NCT00878566.

  5. Exploring Occupational and Behavioral Risk Factors for Obesity in Firefighters: A Theoretical Framework and Study Design

    BongKyoo Choi

    2011-12-01

    Full Text Available Firefighters and police officers have the third highest prevalence of obesity among 41 male occupational groups in the United States (US. However, few studies have examined the relationship of firefighter working conditions and health behaviors with obesity. This paper presents a theoretical framework describing the relationship between working conditions, health behaviors, and obesity in firefighters. In addition, the paper describes a detailed study plan for exploring the role of occupational and behavioral risk factors in the development of obesity in firefighters enrolled in the Orange County Fire Authority Wellness Fitness Program. The study plan will be described with emphasis on its methodological merits: adopting a participatory action research approach, developing a firefighter-specific work and health questionnaire, conducting both a cross-sectional epidemiological study using the questionnaire and a sub-study to assess the validity of the questionnaire with dietary intake and physical activity measures, and evaluating the strengths and weaknesses of the body mass index as an obesity measure in comparison to skinfold-based percent body fat. The study plan based on a theoretical framework can be an essential first step for establishing effective intervention programs for obesity among professional and voluntary firefighters.

  6. The Effects of General System Justification on Corruption Perception and Intent

    Xuyun Tan

    2016-07-01

    Full Text Available Previous research stresses that system justifying belief can weaken corruption perception, by this possibly fostering unjust behaviors. However, general results of the effect of general system justification on corruption are ambiguous, indicating also a lessening impact. We conducted a line of studies trying to elucidate these circumstances by testing the effect of general system justification on corruption perception and intention. In addition, we explored institutional trust as a possible mediator in this process. For this purpose we conducted three studies. The first two studies examined the association between general system justification and corruption. In Study 1, a correlational design was run using questionnaires to assess the relation between general system justification and corruption perception as well as corruption intention. In Study 2, an experimental design was conducted manipulating general system justification via exposure to high or low system threat condition, then measuring its effect on corruption perception and corrupt intention. In Study 3, two sub-studies using correlational and experimental designs were run to explore the mediating role of institutional trust, respectively. Results replicated former studies showing that general system justification is negatively associated with corruption perception. However, they also showed a negative correlation with corrupt intention. Furthermore, they showed that institutional trust mediated the relation between general system justification and corruption. We suggest to consider these findings to further elucidate the psychological basis underlying different effects of general system justification on human behaviors.

  7. Pathways to Well-Being in Later Life: Socioeconomic and Health Determinants Across the Life Course of Australian Baby Boomers.

    Kendig, Hal; Loh, Vanessa; O'Loughlin, Kate; Byles, Julie; Nazroo, James Y

    2016-01-01

    In many countries like Australia and the United States, baby boomers are referred to as the 'lucky cohort', yet there has been little research on the origins and extent of inequalities within this cohort. This study uses path analysis to investigate direct and indirect effects of childhood and adult socioeconomic status and health on two subjective well-being measures: quality of life and life satisfaction. Retrospective life course data were obtained for 1,261 people aged 60 to 64 in the 2011-12 Life Histories and Health survey, a sub-study of the Australian 45 and Up Study. Supporting an accumulation model, the number of negative childhood and adult exposures were inversely related to both types of well-being. Consistent with a critical period model, childhood exposures had small but significant effects on subjective well-being and were relatively more important for quality of life than for life satisfaction. However, these childhood effects were largely indirect and significantly mediated by more proximal adult exposures, providing support for a pathway model. A key implication of this research is that the critical period for later life well-being is significant in adulthood rather than childhood, suggesting that there may be key opportunities for improving individuals' later life well-being far beyond the early, formative years. This research highlights the importance of understanding how earlier life exposures impact experiences in later life, and investing in health and socioeconomic opportunities to reduce inequalities across all stages of life.

  8. The value of a rapid contrast-enhanced angio-MRI protocol in the detection of head and neck paragangliomas in SDHx mutations carriers: a retrospective study on behalf of the PGL.EVA investigators*

    Gravel, Guillaume; Hernigou, Anne [Hopital Europeen Georges Pompidou, Assistance Publique-Hopitaux de Paris, Service de Radiologie, Paris (France); Niccoli, Patricia [Centre Hospitalier Universitaire la Timone, Assistance Publique-Hopitaux de Marseille, Service d' Endocrinologie, Diabete et Maladies Metaboliques, Marseille (France); Rohmer, Vincent [Centre Hospitalier Universitaire d' Angers, Service d' Endocrinologie, Diabetologie, Nutrition, Angers (France); LUNAM Universite, INSERM, U1063, Angers (France); Moulin, Guy [Centre Hospitalier Universitaire la Timone, Assistance Publique-Hopitaux de Marseille, Service de Radiologie, Marseille (France); Borson-Chazot, Francoise [Federation d' Endocrinologie, Hospices civils de Lyon, Groupement Hospitalier Est, Lyon (France); Universite de Lyon, Faculte de Medecine Lyon-Est, Lyon (France); Cancer Research Center of Lyon, INSERM UMR1052, UMR CNRS 5286, Lyon (France); Rousset, Pascal [Hospices civils de Lyon, Groupement Hospitalier Est, Service de Radiologie, Lyon (France); Pasco-Papon, Anne [Centre Hospitalier Universitaire d' Angers, Service de Radiologie, Angers (France); Marcus, Claude [Centre Hospitalo-Universitaire de Reims, Service de Radiologie, Reims (France); Dubrulle, Frederique [Centre Hospitalo-Universitaire de Lille, Service de Radiologie, Lille (France); Gouya, Herve [Hopital Cochin, Assistance Publique-Hopitaux de Paris, Service de Radiologie, Paris (France); Bidault, Francois [Institut Gustave Roussy, Service de Radiologie, Villejuif (France); Dupas, Benoit [Centre Hospitalo-Universitaire de Nantes, Service de Radiologie, Nantes (France); Gabrillargues, Jean [Centre Hospitalo-Universitaire de Clermont-Ferrand, Service de Neuroradiologie, Clermont Ferrand (France); Caumont-Prim, Aurore [Unite d' Epidemiologie et de Recherche Clinique, Assistance Publique-Hopitaux de Paris, Hopital Europeen Georges Pompidou, Paris (France); Centre d' investigation Epidemiologique 4, INSERM, Paris (France); Gimenez-Roqueplo, Anne-Paule [Hopital Europeen Georges Pompidou, Assistance Publique-Hopitaux de Paris, Service de Genetique, Paris (France); Paris Cardiovascular Research Center, INSERM, UMR970, Paris (France); Universite Paris Descartes, Sorbonne Paris Cite, Faculte de Medecine, Paris (France); Halimi, Philippe [Hopital Europeen Georges Pompidou, Assistance Publique-Hopitaux de Paris, Service de Radiologie, Paris (France); Universite Paris Descartes, Sorbonne Paris Cite, Faculte de Medecine, Paris (France)

    2016-06-15

    To assess the performance of a simplified MRI protocol consisting of a contrast-enhanced three-dimensional MR angiography (CE-MRA) in association with a post-contrast T1-weighted sequence (T1WIV) for the detection of HNPGLs in SDHx mutation carriers. This retrospective sub-study is based on the multicenter PGL.EVA cohort, which prospectively enrolled SDHx mutation carriers from 2005 to 2009; 157 index cases or relatives were included. CE-MRA and the T1WIV images were read solely with knowledge of the clinical data but blind to the diagnosis. Sensitivity, specificity and likelihood ratios for the simplified MRI protocol were compared to the full MRI protocol reading results and to the gold standard status obtained through the consensus of an expert committee. The sensitivity and specificity of the readings of the simplified MRI protocol were, respectively, 88.7 % (95 % CI = 78.1-95.3) and 93.7 % (95 % CI = 86.8-97.7) versus 80.7 % (95 % CI = 68.6-89.6) and 94.7 % (95 % CI = 88.1-98.3) for the readings of the full MRI protocol. The simplified post-contrast MRI with shorter duration (5 to 10 minutes) showed no performance difference compared to the lengthy standard full MRI and can be proposed for the detection of head and neck paragangliomas (HNPGLs) in SDHx mutation carriers. (orig.)

  9. [Fourth evaluation of the law on the review of termination of life on request and assisted suicide (Euthanasia Act)].

    van der Heide, A; Onwuteaka-Philipsen, B D; van Delden, J J M; Gevers, J K M; van der Maas, P J; van der Wal, G

    2005-09-24

    This fall, an extensive study will start to evaluate the Dutch Euthanasia Act. This law was enacted in 2002. According to this law, physicians must report cases of euthanasia and physician-assisted suicide. The cases are then judged by regional euthanasia review committees consisting of a lawyer, a physician and an ethicist. Only if they conclude that the case does not meet the requirements for prudent practice, it will be sent to the public prosecutor. The study will be focused on the practice of medical end-of-life decision-making, the functioning and effects of the Euthanasia Act, and opinions of physicians about the scope of the law and the demarcation between different end-of-life decisions. The study will comprise 4 sub-studies: a judicial evaluation, a death certificate study, a survey among physicians and a panel study among physicians, nurses, members of euthanasia review committees, lawyers and ethicists. This study is the fourth in a row of nationwide studies into end-of-life practices that have been performed since 1990. The previous studies contributed to the public debate about medical care at the end of life and to the development of policy in this field. It is expected that this study, by providing up-to-date information on and insight into end-of-life care in the Netherlands, will do the same.

  10. Optimal cutoff for the evaluation of insulin resistance through triglyceride-glucose index: A cross-sectional study in a Venezuelan population.

    Salazar, Juan; Bermúdez, Valmore; Calvo, María; Olivar, Luis Carlos; Luzardo, Eliana; Navarro, Carla; Mencia, Heysa; Martínez, María; Rivas-Ríos, José; Wilches-Durán, Sandra; Cerda, Marcos; Graterol, Modesto; Graterol, Rosemily; Garicano, Carlos; Hernández, Juan; Rojas, Joselyn

    2017-01-01

    Background: Insulin resistance (IR) evaluation is a fundamental goal in clinical and epidemiological research. However, the most widely used methods are difficult to apply to populations with low incomes. The triglyceride-glucose index (TGI) emerges as an alternative to use in daily clinical practice. Therefore the objective of this study was to determine an optimal cutoff point for the TGI in an adult population from Maracaibo, Venezuela. Methods: This is a sub-study of Maracaibo City Metabolic Syndrome Prevalence Study, a descriptive, cross-sectional study with random and multi-stage sampling. For this analysis, 2004 individuals of both genders ≥18 years old with basal insulin determination and triglycerides triglyceride (mg / dl) x Fasting glucose (mg / dl)] / 2. Results: The TGI in the general population was 4.6±0.3 (male: 4.66±0.34 vs. female: 4.56±0.33, p=8.93x10 -10 ). The optimal cutoff point was 4.49, with a sensitivity of 82.6% and specificity of 82.1% (AUC=0.889, 95% CI: 0.854-0.924). There were no significant differences in the predictive capacity of the index when evaluated according to gender and age groups. Those individuals with TGI≥4.5 had higher HOMA2-IR averages than those with TGI index to determine atypical metabolic phenotypes, type 2 diabetes mellitus and even cardiovascular risk in our population.

  11. Telemedicine Can Replace the Neurologist on a Mobile Stroke Unit.

    Wu, Tzu-Ching; Parker, Stephanie A; Jagolino, Amanda; Yamal, Jose-Miguel; Bowry, Ritvij; Thomas, Abraham; Yu, Amy; Grotta, James C

    2017-02-01

    The BEST-MSU study (Benefits of Stroke Treatment Delivered Using a Mobile Stroke Unit) is a comparative effectiveness trial in patients randomized to mobile stroke unit or standard management. A substudy tested interrater agreement for tissue-type plasminogen activator eligibility between a telemedicine vascular neurologist and onboard vascular neurologist. On scene, both the telemedicine vascular neurologist and onboard vascular neurologist independently evaluated the patient, documenting their tissue-type plasminogen activator treatment decision, National Institutes of Health Stroke Scale score, and computed tomographic interpretation. Agreement was determined using Cohen κ statistic. Telemedicine-related technical failures that impeded remote assessment were recorded. Simultaneous and independent telemedicine vascular neurologist and onboard vascular neurologist assessment was attempted in 174 patients. In 4 patients (2%), the telemedicine vascular neurologist could not make a decision because of technical problems. The telemedicine vascular neurologist agreed with the onboard vascular neurologist on 88% of evaluations (κ=0.73). Remote telemedicine vascular neurologist assessment is reliable and accurate, supporting either telemedicine vascular neurologist or onboard vascular neurologist assessment on our mobile stroke unit. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02190500. © 2017 American Heart Association, Inc.

  12. Interaction of cholesterol ester transfer protein polymo- rphisms, body mass index, and birth weight with the risk of dyslipidemia in children and adolescents: the CASPIAN-III study

    Motahar Heidari-Beni

    2015-11-01

    Full Text Available Objective(s: This study aims to investigate joint association between cholesterol ester transfer protein (CETP polymorphisms and body mass index (BMI or birth weight with the risk of dyslipidemia in Iranian children and adolescents. Materials and Methods:This study was conducted as a sub-study of the “school-based nationwide health survey” (CASPIAN-III. We randomly selected 750 samples from the whole blood samples. Real-time PCR and high resolution melt (HRM analysis were performed to determine Taq1B (rs708272 and A373P (rs5880 polymorphisms. Results:Taq1B polymorphism increased HDL-C, and total cholesterol (TC as well as decreased triglyceride and LDL-C concentrations. LDL-C and triglyceride levels were significantly higher and HDL-C and TC levels were significantly lower among those with A373P polymorphism. CT/TT genotype in Taq1B polymorphism showed a protective effect on dyslipidemia (OR= 0.12, 95%CI: 0.07-0.20. G allele of A373P polymorphism increased the risk of dyslipidemia (OR=4.10, 95%CI: 2.14, 7.83 after adjusting the confounders. We observed interactive effects of CETP gene polymorphisms and BMI or birth weight on dyslipidemia. Conclusion:Findings showed Taq1B polymorphism might have a protective effect and A373P polymorphism had deleterious effect on dyslipidemia in Iranian children and adolescents. These associations interacted with BMI and birth weight.

  13. Change in quality of life and immune markers after a stay at a raw vegan institute: a pilot study

    Link, Lilli B.; Hussaini, Najeeb S.; Jacobson, Judith S.

    2008-01-01

    Objective The purpose of this study was to explore changes in quality of life (QOL), anxiety, stress, and immune markers after a stay at a raw vegan institute. Design Prospective observational study. Setting English-speaking attendees at Hippocrates Health Institute (Florida, US), a raw vegan institute, were recruited on arrival and typically stayed 1–3 weeks. Main outcome measures Participants completed questionnaires assessing overall QOL (SF-36), dietary QOL (QOL Related to Dietary Change), perceived stress (Perceived Stress Scale), anxiety, and depression (Hospital Anxiety and Depression Scale) upon arrival and 12 weeks later. C-reactive protein (CRP), lymphocytes, T cells, CD4 cells, CD8 cells, B cells, and NK cells were measured at baseline and 12 weeks in participants living in North America. Results Of 107 attendees eligible for the questionnaire study and 82 for the blood marker substudy, 51 and 38 participants, respectively, provided complete follow-up data. Overall QOL improved 11.5% (p=0.001), driven mostly by the mental component. Anxiety decreased 18.6% (p=0.009) and perceived stress decreased 16.4% (praw vegan institute was associated with improved mental and emotional QOL. Studies are needed to determine the feasibility of conducting a clinical trial of the raw vegan diet among healthy people, and subsequently among patients with specific diseases. PMID:18534324

  14. Non-vitamin K antagonist oral anticoagulants compared with warfarin at different levels of INR control in atrial fibrillation: A meta-analysis of randomized trials.

    Carmo, João; Ferreira, Jorge; Costa, Francisco; Carmo, Pedro; Cavaco, Diogo; Carvalho, Salomé; Morgado, Francisco; Adragão, Pedro; Mendes, Miguel

    2017-10-01

    The efficacy and safety of warfarin for stroke prevention in atrial fibrillation (AF) depend on the time in the therapeutic range (TTR) with an international normalised ratio (INR) of 2.0-3.0. This meta-analysis focused the relative efficacy and safety of non-VKA oral anticoagulants (NOAC) compared with warfarin at different thresholds of centre's TTR (cTTR). We searched PubMed, Embase, CENTRAL and websites of regulatory agencies, limiting searches to randomized phase 3 trials. Primary outcomes were stroke or systemic embolism (SSE) and major or non-major clinically relevant (NMCR) bleeding. We used a random-effects model to pool effect on outcomes according to different thresholds of cTTR. Four TTR sub-studies with a total of 71,222 patients were included. The benefit of NOAC in reducing SSE compared with warfarin was significantly higher in patients at cTTRwarfarin in patients at all sub-groups (0.67, 0.54-0.83 for patients at cTTRwarfarin for stroke prevention is lost above a cTTR threshold of approximately 70%, but the relative safety appears to be less modified by the centre-based quality of INR control. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. Rare Functional Variant in TM2D3 is Associated with Late-Onset Alzheimer's Disease.

    Johanna Jakobsdottir

    2016-10-01

    Full Text Available We performed an exome-wide association analysis in 1393 late-onset Alzheimer's disease (LOAD cases and 8141 controls from the CHARGE consortium. We found that a rare variant (P155L in TM2D3 was enriched in Icelanders (~0.5% versus <0.05% in other European populations. In 433 LOAD cases and 3903 controls from the Icelandic AGES sub-study, P155L was associated with increased risk and earlier onset of LOAD [odds ratio (95% CI = 7.5 (3.5-15.9, p = 6.6x10-9]. Mutation in the Drosophila TM2D3 homolog, almondex, causes a phenotype similar to loss of Notch/Presenilin signaling. Human TM2D3 is capable of rescuing these phenotypes, but this activity is abolished by P155L, establishing it as a functionally damaging allele. Our results establish a rare TM2D3 variant in association with LOAD susceptibility, and together with prior work suggests possible links to the β-amyloid cascade.

  16. The Japan Statin Treatment Against Recurrent Stroke (J-STARS) Echo Study: Rationale and Trial Protocol.

    Toyoda, Kazunori; Minematsu, Kazuo; Yasaka, Masahiro; Nagai, Yoji; Hosomi, Naohisa; Origasa, Hideki; Kitagawa, Kazuo; Uchiyama, Shinichiro; Koga, Masatoshi; Matsumoto, Masayasu

    2017-03-01

    The preventive effect of 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins) on progression of carotid intima-media complex thickness (IMT) has been shown exclusively in nonstroke Western patients. The Japan Statin Treatment Against Recurrent Stroke (J-STARS) Echo Study aims to determine the effect of pravastatin on carotid IMT in Japanese patients with hyperlipidemia who developed noncardioembolic ischemic stroke. This is a substudy of the J-STARS, a multicenter, randomized, open-label, blinded-end point, parallel-group trial to examine whether pravastatin reduces stroke recurrence in patients with noncardioembolic stroke. The patients are randomized to receive pravastatin (10 mg daily) or not to receive any statins. Carotid ultrasonography is performed by well-trained certified examiners in each participating institute, and the recorded data are measured centrally. The primary outcome is change in the IMT of the distal wall in a consecutive 2-cm section on the central side of the common carotid artery bifurcation over 5 years of observation. The trial may help determine if the usual dose of pravastatin for daily clinical practice in Japan can affect carotid IMT in Japanese patients with noncardioembolic stroke. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  17. Using a mixed-methods design to examine nurse practitioner integration in British Columbia.

    Sangster-Gormley, Esther; Griffith, Janessa; Schreiber, Rita; Borycki, Elizabeth

    2015-07-01

    To discuss and provide examples of how mixed-methods research was used to evaluate the integration of nurse practitioners (NPs) into a Canadian province. Legislation enabling NPs to practise in British Columbia (BC) was enacted in 2005. This research evaluated the integration of NPs and their effect on the BC healthcare system. Data were collected using surveys, focus groups, participant interviews and case studies over three years. Data sources and methods were triangulated to determine how the findings addressed the research questions. The challenges and benefits of using the multiphase design are highlighted in the paper. The multiphase mixed-methods research design was selected because of its applicability to evaluation research. The design proved to be robust and flexible in answering research questions. As sub-studies within the multiphase design are often published separately, it can be difficult for researchers to find examples. This paper highlights ways that a multiphase mixed-methods design can be conducted for researchers unfamiliar with the process.

  18. Association of elevated blood pressure with low distress and good quality of life: results from the nationwide representative German Health Interview and Examination Survey for Children and Adolescents.

    Berendes, Angela; Meyer, Thomas; Hulpke-Wette, Martin; Herrmann-Lingen, Christoph

    2013-05-01

    Quality of life is often impaired in patients with known hypertension, but it is less or not at all reduced in people unaware of their elevated blood pressure. Some studies have even shown less self-rated distress in adults with elevated blood pressure. In this substudy of the nationwide German Health Interview and Examination Survey for Children and Adolescents (KIGGS), we addressed the question whether, also in adolescents, hypertensive blood pressure is linked to levels of distress and quality of life. Study participants aged 11 to 17 years (N = 7688) received standardized measurements of blood pressure, quality of life (using the Children's Quality of Life Questionnaire), and distress (Strengths and Difficulties Questionnaire). Elevated blood pressure was twice as frequent as expected, with 10.7% (n = 825) above published age-, sex- and height-adjusted 95th percentiles. Hypertensive participants were more likely to be obese and to report on adverse health behaviors, but they showed better academic success than did normotensive participants. Elevated blood pressure was significantly and positively associated with higher self- and parent-rated quality of life (for both, p ≤ .006), less hyperactivity (for both, p parent-rated emotional (p pressure to better well-being and low distress can partly be explained by the absence of confounding physical comorbidity and the unawareness of being hypertensive. It also corresponds to earlier research suggesting a bidirectional relationship with repressed emotions leading to elevated blood pressure and, furthermore, elevated blood pressure serving as a potential stress buffer.

  19. The effect of dietary intervention on paraffin-stimulated saliva and dental health of children participating in a randomized controlled trial.

    Laine, M A; Tolvanen, M; Pienihäkkinen, K; Söderling, E; Niinikoski, H; Simell, O; Karjalainen, S

    2014-02-01

    The aim was to study the impact of dietary intervention on the properties of paraffin-stimulated saliva, and on dental caries. At 7 months of age 1062 infants (540 intervention; 522 controls) started in the prospective, randomized Special Turku Intervention Project (STRIP) aimed at restricting the child's saturated fat and cholesterol intake to prevent atherosclerosis of adult age (www.clinicaltrials.gov NCT 00223600). At 3 years of age, every fifth child was invited to an oral sub-study, and 148 (78 boys) children attended. At 6, 9, 12 and 16 years of age 135, 127, 114 and 88 children were restudied, respectively. Dietary intakes of carbohydrates, protein, saturated fat, calcium, phosphate, and fibre were regularly recorded using 4-day food records. Height and weight were regularly monitored. Paraffin-stimulated saliva samples were collected at 6, 9, 12 and 16 years of age, and analyzed for flow rate, buffer capacity, calcium, phosphate and proteins. Dental health was recorded and expressed as d3mft/D3MFT, and as time of caries onset. Dietary intakes of calcium, phosphate and fibre, and salivary flow rate increased with time in both groups (pparaffin-stimulated salivary flow rate. The concentration of salivary calcium was directly correlated to dental health. Higher salivary flow rate in the intervention group is believed to be due to higher fibre intake in the intervention group. Copyright © 2013 Elsevier Ltd. All rights reserved.

  20. Childhood abuse, parental warmth, and adult multisystem biological risk in the Coronary Artery Risk Development in Young Adults study.

    Carroll, Judith E; Gruenewald, Tara L; Taylor, Shelley E; Janicki-Deverts, Denise; Matthews, Karen A; Seeman, Teresa E

    2013-10-15

    Childhood abuse increases adult risk for morbidity and mortality. Less clear is how this "toxic" stress becomes embedded to influence health decades later, and whether protective factors guard against these effects. Early biological embedding is hypothesized to occur through programming of the neural circuitry that influences physiological response patterns to subsequent stress, causing wear and tear across multiple regulatory systems. To examine this hypothesis, we related reports of childhood abuse to a comprehensive 18-biomarker measure of multisystem risk and also examined whether presence of a loving parental figure buffers against the impact of childhood abuse on adult risk. A total of 756 subjects (45.8% white, 42.7% male) participated in this ancillary substudy of the Coronary Artery Risk Development in Young Adults Study. Childhood stress was determined by using the Risky Families Questionnaire, a well-validated retrospective self-report scale. Linear regression models adjusting for age, sex, race, parental education, and oral contraceptive use found a significant positive relationship between reports of childhood abuse and multisystem health risks [B (SE) = 0.68 (0.16); P childhood was associated with lower multisystem health risks [B (SE) = -0.40 (0.14); P childhood had the highest multisystem risk in adulthood.

  1. Perceived Stress, Its Physiological Correlates, and Quality of Life in Patients With Irritable Bowel Syndrome.

    Weaver, Kristen R; Melkus, Gail D'Eramo; Fletcher, Jason; Henderson, Wendy A

    2018-05-01

    Irritable bowel syndrome (IBS) is a chronic, common disorder of the gastrointestinal tract associated with high psychological comorbidity and diminished quality of life. Patients with IBS display a heightened sensitivity to stress, although the literature is inconsistent as to whether they have a dysregulated stress response. The purpose of the present investigation, a substudy of a larger research effort, was to examine physiological correlates of perceived stress in patients with IBS (cortisol and adrenocorticotropic hormone) and to explore associations between perceived stress and quality of life. A total of 101 participants (35 with IBS [predominant subtypes IBS-constipation and IBS-diarrhea] and 66 healthy controls [HCs]) completed self-report inventories regarding perceived stress and quality of life, and fasting peripheral blood was drawn. Participants with IBS did not differ from the HC in demographic or physiological measures but did differ in psychological measures, reporting significantly higher levels of perceived stress and lower levels of quality of life. Perceived stress and quality of life were not significantly associated in IBS participants. However, differential findings of the stress response were found within IBS participants by sex, race, and subtype. These findings illustrate the heterogeneity of the IBS patient population, underscore the necessity of evaluating larger sample sizes and increasing the diversity of such samples to include males and ethnic minorities, and demonstrate the importance of taking an individualized approach to evaluation and treatment in the IBS patient population.

  2. Usefulness of Serum B-Type Natriuretic Peptide Levels in Comatose Patients Resuscitated from Out-of-Hospital Cardiac Arrest to Predict Outcome

    Frydland, Martin; Kjaergaard, Jesper; Erlinge, David

    2016-01-01

    N-terminal pro-B-type natriuretic (NT-proBNP) is expressed in the heart and brain, and serum levels are elevated in acute heart and brain diseases. We aimed to assess the possible association between serum levels and neurological outcome and death in comatose patients resuscitated from out......-of-hospital cardiac arrest (OHCA). Of the 939 comatose OHCA patients enrolled and randomized in the Targeted Temperature Management (TTM) trial to TTM at 33°C or 36°C for 24 hours, 700 were included in the biomarker substudy. Of these, 647 (92%) had serum levels of NT-proBNP measured 24, 48, and 72 hours after return...... of spontaneous circulation (ROSC). Neurological outcome was evaluated by the Cerebral Performance Category (CPC) score and modified Rankin Scale (mRS) at 6 months. Six hundred thirty-eight patients (99%) had serum NT-proBNP levels ≥125 pg/ml. Patients with TTM at 33°C had significantly lower NT-proBNP serum...

  3. Anticoagulated patient's perception of their illness, their beliefs about the anticoagulant therapy prescribed and the relationship with adherence: impact of novel oral anticoagulant therapy - study protocol for The Switching Study: a prospective cohort study.

    Auyeung, Vivian; Patel, Jignesh P; Abdou, John K; Vadher, Bipin; Bonner, Lynda; Brown, Alison; Roberts, Lara N; Patel, Raj K; Arya, Roopen

    2016-01-01

    Anticoagulant therapy is prescribed for millions of patients worldwide for the prevention and treatment of both arterial and venous thrombosis. Historically, only vitamin K antagonists have been available for clinicians to prescribe. The anticoagulation landscape is changing. The recent availability of the novel oral anticoagulants overcome many of the disadvantages associated with vitamin K antagonists. However the lack of formal monitoring and clinic follow-up is a concern for clinicians, as medication adherence is being assumed, which is known to decline in patients prescribed medications for chronic conditions. The switching study is a programme of work investigating the association between medication adherence and patient's beliefs about anticoagulation therapy (warfarin and subsequently novel oral anticoagulants), together with beliefs about their illness and anticoagulation related quality of life. The anticoagulation database at King's College Hospital will be interrogated and two groups of patients will be identified; those with a time in therapeutic range on warfarin of ≥75 % and those beliefs about medications compared. Those patients in the time in therapeutic range beliefs about medications, re-evaluated on the novel agent. The results from these sub-studies, will inform a clinical pathway to support patients on these novel agents, which will be evaluated in an independent group of patients. The results from the switching study will be used to develop a clinical pathway to support patient's prescribed novel oral anticoagulant therapy long-term.

  4. Usefulness of a three-dimensional stereotaxic ROI template on anatomically standardised {sup 99m}Tc-ECD SPET

    Takeuchi, Ryo [Department of Internal Medicine, Division of Nuclear Medicine, Nishi-Kobe Medical Center, Kobe (Japan); Yonekura, Yoshiharu [Biomedical Imaging Research Center, Fukui Medical University, Fukui (Japan); Matsuda, Hiroshi [Department of Radiology, National Center Hospital for Mental, Tokyo (Japan); Konishi, Junji [Department of Nuclear Medicine and Diagnostic Imaging, Graduate School of Medicine, Kyoto University, Kyoto (Japan)

    2002-03-01

    We have constructed a three-dimensional stereotaxic ROI template (3DSRT) on anatomically standardised cerebral blood flow (CBF) single-photon emission tomography (SPET) images to objectively estimate regional CBF (rCBF). The 3DSRT is composed of 259 regions of interest (ROIs) in 11 segments (1, superior frontal; 2, middle and inferior frontal; 3, primary sensorimotor; 4, parietal; 5, angular; 6, temporal; 7, occipital; 8, pericallosal; 9, lenticular nucleus; 10, thalamus; 11, hippocampus) on each side. We measured the rCBF values of the 518 ROIs and calculated the area-weighted average (segmental CBF; sCBF) of the 22 segments based on the rCBF in each ROI. We compared vascular reserve before and after revascularisation surgery using sCBF on anatomically standardised resting and acetazolamide (Acz)-challenged CBF SPET images, which were obtained using an equal-volume-split dual-injection single-day protocol [resting and vascular reserve (RVR) method] in 13 patients who had not suffered any major stroke but did have significant cerebrovascular stenosis. Prior to the evaluation, we examined the sCBF values of 16 subjects with various cerebrovascular conditions (8, normal; 3, lacunar infarction; 2, chronic infarction; 2, meningioma; 1, aneurysm) using physiological saline instead of Acz (placebo study) in order to confirm the reproducibility of the RVR method. In the placebo study we observed excellent linearity (y=1.444+0.964x) between the 352 pairs of baseline (x) and post-placebo (y) sCBF values in the 16 subjects, irrespective of the segment location. In all of the 13 patients, estimation of sCBF demonstrated impaired vascular reserve pre-operatively and improved vascular reserve postoperatively. We conclude that the 3DSRT, which could be identically set on the anatomically standardised images obtained at baseline and after Acz injection, allowed objective assessment of the pre- and postoperative vascular reserve, which was not easy with conventional ROI settings

  5. Stent-protected angioplasty versus carotid endarterectomy in patients with carotid artery stenosis: meta-analysis of randomized trial data

    Wiesmann, Martin; Schoepf, Veronika; Brueckmann, Hartmut; Jansen, Olav

    2008-01-01

    Stent-protected angioplasty of carotid artery stenosis may be an alternative to surgical endarterectomy. Results published so far are indecisive, with evidence both in favour of and against this procedure. After the recent publication of two large European multicentre trials (SPACE and EVA-3S) almost 3,000 patients have been included in randomized studies. For this report, we therefore conducted a systematic review of randomized studies that compared endovascular treatment with surgery for carotid stenosis. We evaluated seven trials including 2,973 patients. In our meta-analysis endovascular treatment seemed to carry a slightly higher risk for stroke or death within 30 days after the procedure as compared with surgery (8.2% vs. 6.2%; p = 0.04; OR 1.35), whereas the rates of disabling stroke or death within 30 days did not differ significantly (p = 0.47; n.s.). On the other hand, surgery carried a significantly higher risk for cranial nerve palsy (4.7% vs. 0.2%; p < 0.0001; OR 0.17) and myocardial infarction (2.3% vs. 0.9%; p = 0.03; OR 0.37). Long-term effects of both methods still need to be evaluated. Two other large multicentre trials (ICSS and CREST) are ongoing. Results of these studies will increase the database to about 7,000 randomized patients. Future meta-analyses should then allow definitive treatment recommendations. (orig.)

  6. Clinical features and applications of thallium-201. With reference to scintigraphy

    Fujii, Tadashige

    1988-12-01

    Thallium-201 is not only used widely in myocardial imaging but also has a great potential in other various nuclear medicine imaging studies. This paper presents clinical features and applications of thallium-201, focusing on clinical trials with thallium-201 at the Shinshu University School of Medicine. Thallium-201 myocardial scintigraphy offers information on (1) ventricular position and morphology, (2) hypertrophy or dilatation of the left ventricle, (3) hypertrophy or dilatation of the right ventricle, (4) site and extent of myocardial ischemia and infarct, (5) myocardial blood flow, (6) pulmonary congestion or interstitial pulmonary edema, and (7) pericardial effusion. It can be used in the following evaluation or diagnosis: (1) acute or old myocardial infarction, (2) angina pectoris, (3) treatment strategy or prognosis of ischemic heart disease, (4) treatment strategy or observation of bypass graft or drug therapy, (5) hypertrophic or dilated idiopathic cardiomyopathy, (6) myocardial lesions induced by sarcoidosis, collagen disease, and neuro-muscular disease, (7) ventricular hypertrophy and pulmonary edema, and (9) pericarditis, pericardial effusion, and systolic pericarditis associated with underlying disease. The significance of tumor, liver, bone marrow scintigraphies is also referred to. (Namekawa, K) 69 refs.

  7. Distribution of brain infarction in children with tuberculous meningitis and correlation with outcome score at 6 months

    Andronikou, Savvas; Wilmshurst, Jo; Hatherill, Mark; VanToorn, Ronald

    2006-01-01

    Prognostic indicators for tuberculous meningitis (TBM) offer realistic expectations for parents of affected children. Infarctions affecting the basal ganglia are associated with a poor outcome. To correlate the distribution of infarction in children with TBM on CT with an outcome score (OS). CT brain scans in children with TBM were retrospectively reviewed and the distribution of infarctions recorded. The degree of correlation with OS at 6 months was determined. There was a statistically significant association between all sites of infarction (P = 0.0001-0.001), other than hemispheric (P = 0.35), and outcome score. There was also a statistically significant association between all types of infarction (P = 0.0001-0.02), other than hemispheric (P = 0.05), and overall poor outcome. The odds ratio for poor outcome with bilateral basal ganglia and internal capsule infarction was 12. The odds ratio for poor outcome with 'any infarction' was 4.91 (CI 2.24-10.74), with 'bilateral infarctions' 8.50 (CI 2.49-28.59), with basal ganglia infarction 5.73 (CI 2.60-12.64), and for hemispheric infarction 2.30 (CI 1.00-5.28). Infarction is associated with a poor outcome unless purely hemispheric. MRI diffusion-weighted imaging was not part of this study, but is likely to play a central role in detecting infarctions not demonstrated by CT. (orig.)

  8. Sensitivity of {sup 99m}Tc-pyrophosphate scintigraphy in diagnosis of acute myocardial infarction

    Kim, Seong Hee; Park, Tai Que; Chae, Yoo Soon; Kim, Yang Sook [Maryknoll Hospital, Busan (Korea, Republic of)

    1991-01-15

    To assess the difference of the diagnostic sensitivity of {sup 99m}Tc-Pyrophosphate (PYP) myocardial scintigraphy in acute transmural infarction and acute subendocardial infarction, we analyzed 38 patients with a confirmed transmural infarct, 10 with a subendocardial infarct, 2 with old myocardial infarct, and 10 with other cardiovascular disease (2 unstable angina, 6 stable angina, 1 Prinzmetal angina, and 1 atrial fibrillation) according to Berman's criteria for scintigraphic assessment and then come to conclusion; When only focal myocardial uptake wa used as a criteria for positivity, the diagnostic sensitivity of {sup 99m}Tc-PYP scintigraphy in acute subendocardial myocardial infarction was only 40% (4/10) compared with 86.8% (33/38) of acute transmural myocardial infarction. There was no case that was interpreted as focal myocardial uptake in 2 old myocardial infarction and 10 other cardiovascular disease. The incidence of complication was higher in doughnut pattern of myocardial uptake 50% (3/6) than in non-doughnut focal patterns 19.4% (6/31). It is concluded that focal myocardial uptake is a sensitive indicator suggesting acute myocardial necrosis and that {sup 99m}Tc-PYP myocardial scintigraphy is a sensitive technique for diagnosing acute transmural myocardial infarction, but a insensitive method in acute subendocardial infarction, and that the doughnut pattern of myocardial uptake an provide clues to the patient's future course.

  9. Significance and problems of the dynamic CT scan for the diagnosis and treatment of cerebral infarctions

    Morita, Akio; Teraoka, Akira

    1985-01-01

    Dynamic CT scan is a very useful method for the diagnosis of cerebral infarctions and other ischemic disorders. We have used this method for 1) the ultra-early stage diagnosis of major infarctions, 2) the detection of the recanalization and the disruption of the blood-brain barrier, and 3) the detection of latent ischemic lesions. In this report we discussed the clinical cases and the usual use of this dynamic CT scan. We used a GE CT/T8800 scanner for dynamic CT scanning. Manual bolus-contrast-medium injection was done simultaneously with the first scanning, and 6 sequential scannings (scan time: 4.8 s; scan interval: 1.4 s) were done on the same slice level. Especially in major infarctions (e.g., MCA occlusion), OM 40 was the most preferred slice. In cases of ultra-early stage infarctions (i.e., no abnormal lesions in non-enhanced CT), we used this dynamic CT scan immediately after the non-enhanced CT; we could thus obtain information on the ischemic lesions and the ischemic degree. After that we repeated this examination on Days 3, 7, and 14 for the evaluation of the recanalization and blood-brain-barrier disruption. In the cases of TIA and impending or progressing strokes, dynamic CT scan could disclose latent ischemic lesions; in there instances, we treated the patients with intensive to prevent the prognosis from worsening. These benefits and also some problems were discussed. (author)

  10. Anesthesia Technique and Mortality after Total Hip or Knee Arthroplasty: A Retrospective, Propensity Score-matched Cohort Study.

    Perlas, Anahi; Chan, Vincent W S; Beattie, Scott

    2016-10-01

    This propensity score-matched cohort study evaluates the effect of anesthetic technique on a 30-day mortality after total hip or knee arthroplasty. All patients who had hip or knee arthroplasty between January 1, 2003, and December 31, 2014, were evaluated. The principal exposure was spinal versus general anesthesia. The primary outcome was 30-day mortality. Secondary outcomes were (1) perioperative myocardial infarction; (2) a composite of major adverse cardiac events that includes cardiac arrest, myocardial infarction, or newly diagnosed arrhythmia; (3) pulmonary embolism; (4) major blood loss; (5) hospital length of stay; and (6) operating room procedure time. A propensity score-matched-pair analysis was performed using a nonparsimonious logistic regression model of regional anesthetic use. We identified 10,868 patients, of whom 8,553 had spinal anesthesia and 2,315 had general anesthesia. Ninety-two percent (n = 2,135) of the patients who had general anesthesia were matched to similar patients who did not have general anesthesia. In the matched cohort, the 30-day mortality rate was 0.19% (n = 4) in the spinal anesthesia group and 0.8% (n = 17) in the general anesthesia group (risk ratio, 0.42; 95% CI, 0.21 to 0.83; P = 0.0045). Spinal anesthesia was also associated with a shorter hospital length of stay (5.7 vs. 6.6 days; P anesthesia and lower 30-day mortality, as well as a shorter hospital length of stay, after elective joint replacement surgery.

  11. The Basilar Artery on Computed Tomography Angiography Prognostic Score for Basilar Artery Occlusion.

    Alemseged, Fana; Shah, Darshan G; Diomedi, Marina; Sallustio, Fabrizio; Bivard, Andrew; Sharma, Gagan; Mitchell, Peter J; Dowling, Richard J; Bush, Steven; Yan, Bernard; Caltagirone, Carlo; Floris, Roberto; Parsons, Mark W; Levi, Christopher R; Davis, Stephen M; Campbell, Bruce C V

    2017-03-01

    Basilar artery occlusion is associated with high risk of disability and mortality. This study aimed to assess the prognostic value of a new radiological score: the Basilar Artery on Computed Tomography Angiography (BATMAN) score. A retrospective analysis of consecutive stroke patients with basilar artery occlusion diagnosed on computed tomographic angiography was performed. BATMAN score is a 10-point computed tomographic angiography-based grading system which incorporates thrombus burden and the presence of collaterals. Reliability was assessed with intraclass coefficient correlation. Good outcome was defined as modified Rankin Scale score of ≤3 at 3 months and successful reperfusion as thrombolysis in cerebral infarction 2b-3. BATMAN score was externally validated and compared with the Posterior Circulation Collateral score. The derivation cohort included 83 patients with 41 in the validation cohort. In receiver operating characteristic (ROC) analysis, BATMAN score had an area under receiver operating characteristic curve of 0.81 (95% confidence interval [CI], 0.7-0.9) in derivation cohort and an area under receiver operating characteristic curve of 0.74 (95% CI, 0.6-0.9) in validation cohort. In logistic regression adjusted for age and clinical severity, BATMAN score of BATMAN score of BATMAN score had greater accuracy compared with Posterior Circulation Collateral score ( P =0.04). The addition of collateral quality to clot burden in BATMAN score seems to improve prognostic accuracy in basilar artery occlusion patients. © 2017 American Heart Association, Inc.

  12. Noninvasive diagnosis of thrombus in the heart and large vessels

    Masuda, Yoshiaki; Morooka, Nobuhiro; Yoshida, Hideo; Watanabe, Shigeru; Inagaki, Yoshiaki

    1984-01-01

    The usefulness of two dimensional echocardiography (2-D echocardiography) and x-ray computed tomography (CT) for the diagnosis of thrombi in the cardiac cavity and large vessels was studied by comparing them with the findings of invasive methods. Among 56 subjects with mitral stenosis, left atrial thrombi were noted in 12 cases (16 regions) by CT and 8 cases (9 regions) by 2-D echocardiography. In 16 subjects who underwent operations, one false negative case by CT and 3 false negative and one false positive cases by 2-D echocardiography were found. In 80 subjects with myocardial infarction 2-D echocardiography, CT and left ventriculography (LVG) were performed at approximately the same time. Thrombi were detected in 10 subjects (12.5%) by 2-D echocardiography, in 15 (18.8%) by CT and in 14 (17.5%) by LVG. Although mural thrombi in abdominal aortic aneurysm were detected very easily, thin thrombi surrounding the false lumen of the dissecting aneurysm were not detected ultrasonographically. These thrombi were only detected by the enhanced CT. Our results show the usefulness of both methods for detecting thrombi in the heart and large vessels. CT can distinguish the thrombi more clearly than 2-D echocardiography, but 2-D echocardiography is performed more easily, safely and economically than CT. (author)

  13. Distribution territories and causative mechanisms of ischemic stroke

    Rovira, A.; Grive, E.; Alvarez-Sabin, J. [Unidad de Resonancia Magnetica, Hospital Vall d' Hebron, Barcelona (Spain)

    2005-03-01

    Ischemic stroke prognosis, risk of recurrence, clinical assessment, and treatment decisions are influenced by stroke subtype (anatomic distribution and causative mechanism of infarction). Stroke subtype diagnosis is better achieved in the early phase of acute ischemia with the use of multimodal MR imaging. The pattern of brain lesions as shown by brain MR imaging can be classified according to a modified Oxfordshire method, based on the anatomic distribution of the infarcts into six groups: (1) total anterior circulation infarcts, (2) partial anterior circulation infarcts, (3) posterior circulation infarcts, (4) watershed infarcts, (5) centrum ovale infarcts, and (6) lacunar infarcts. The subtype of stroke according to its causative mechanism is based on the TOAST method, which classifies stroke into five major etiologic groups: (1) large-vessel atherosclerotic disease, (2) small-vessel atherosclerotic disease, (3) cardioembolic source, (4) other determined etiologies, and (5) undetermined or multiple possible etiologies. The different MR imaging patterns of acute ischemic brain lesions visualized using diffusion-weighted imaging and the pattern of vessel involvement demonstrated with MR angiography are essential factors that can suggest the most likely causative mechanism of infarction. This information may have an impact on decisions regarding therapy and the performance of additional diagnostic tests. (orig.)

  14. Relationship between blood uric and acute cerebral infarction

    Yin Zhanxia; Zhao Danyang

    2011-01-01

    Objective: To study the relationship between blood uric acid and acute cerebral infarction. Methods: The level of blood uric acid and prevalence of hyperuricemia (HUA) were compared in 360 patients with acute cerebral infarction and 300 patients without it. According to the level of blood uric acid, 360 acute cerebral infarction patients were divided into HUA and normouricemia (NUA) groups. Age, sex, body mass index (BMI), blood glucose and total cholesterol were compared between the HUA and NUA group. The degree of neurological functional defection was compared between the two groups when patients were attacked by acute cerebral infarction. After a recovery treatment, the neurological functional defection of the two groups was compared a second time. Results: (1)The average blood uric acid level and prevalence of HUA were higher in patients with acute cerebral infarction. (2) The BMI, blood glucose and total cholesterol were higher in HUA group than in NUA group. (3) The neurological functional defection was more serious in HUA group when patients were attacked by acute cerebral infarction and after a recovery treatment. Conclusion: Hyperuricemia is related to acute cerebral infarction. (authors)

  15. Distal protection filter device efficacy with carotid artery stenting: comparison between a distal protection filter and a distal protection balloon.

    Iko, Minoru; Tsutsumi, Masanori; Aikawa, Hiroshi; Matsumoto, Yoshihisa; Go, Yoshinori; Nii, Kouhei; Abe, Gorou; Ye, Iwae; Nomoto, Yasuyuki; Kazekawa, Kiyoshi

    2013-01-01

    This retrospective study aimed to compare the effectiveness of the embolization prevention mechanism of two types of embolic protection device (EPD)-a distal protection balloon (DPB) and a distal protection filter (DPF). Subjects were 164 patients scheduled to undergo carotid artery stenting: a DPB was used in 82 cases (DPB group) from April 2007 until June 2010, and a DPF was used in 82 cases (DPF group) from July 2010 to July 2011. Rates of positive findings on postoperative diffusion-weighted imaging (DWI) and stroke incidence were compared. Positive postoperative DWI results were found in 34 cases in the DPB group (41.4 %), but in only 22 cases in the DPF group (26.8 %), and there was only a small significant difference within the DPF group. In the DPB group, there was one case of transient ischemic attack (TIA) (1.2 %) and four cases of brain infarction (2 minor strokes, 2 major strokes; 4.9 %), compared to the DFP group with one case of TIA (1.2 %) and no cases of minor or major strokes. In this study, significantly lower rates of occurrence of DWI ischemic lesions and intraoperative embolization were associated with use of the DPF compared to the DPB.

  16. Evaluation of cardiac involvement using radionuclide myuocardial imaging in patients with Takayasu arteritis

    Yang Minfu; Guo Xinhua; He Zuoxiang; Jiang Xiongjing; Dou Kefei

    2008-01-01

    Objective: The aim of the study was to assess the value of radionuclide myocardial imaging in the evaluation of cardiac involvement in patients with Takayasu arteritis (TA). Methods: The 99 Tc m -methoxyisobutylisonitrile myocardial perlusion imaging (MIBI-MPI) and (or) 18 F-fluorodeoxyglucose (FDG) PET imaging findings in 12 TA patients [3 men and 9 women, mean age (35 ± 15) years] with coronary lesions (CL; n=8) or aortic insufficiency (AI; n=4) were retrospectively reviewed and analysed. Of the 4 AI-TA patients, 1 underwent exercise MIBI-MPI, 1 underwent pharmacologic stress MIBI-MPI and 2 un- derwent resting MIBI-MPI. Of the 8 CL-TA patients, 4 pnderwent MIBI-MPI (2 stress and 2 rest) and 4 un- derwent a dual-isotope simultaneous acquisition (DISA) SPECT protocol after injection of MIBI and FDG. Results: All 4 AI-TA patients showed left ventricular enlargement but no peffusion abnormalities. In 3 CL- TA patients with no documented infarct, MPI or DISA showed stress ischemia (n=2) or mismatched perfusion-metabolism defects (n=1). In the remaining 5 CL-TA patients with documented infarcts, 2 showed large perfusion defects on resting MIBI and 3 showed matched perfusion-metabolism defects on DISA SPECT. Conclusion: Radionuclide imaging is useful in providing a comprehensive functional evaluation for TA patients with cardiac involvement. (authors)

  17. Diffusion-weighted imaging as a problem-solving tool in the evaluation of patients with acute strokelike syndromes.

    Schaefer, P W

    2000-10-01

    This article addresses syndromes that clinically and/or radiologically resemble acute stroke. These syndromes generally fall into four categories. (1) Patients with acute neurological deficits with nonischemic lesions and no acute abnormality on diffusion-weighted images. These patients may have peripheral vertigo, migraines, seizures, dementia, functional disorders, amyloid angiopathy, or metabolic disorders. When these patients present, we can confidently predict that they are not undergoing infarction. (2) Patients with ischemic lesions with reversible clinical deficits. Nearly 50% of patients with transient ischemic attacks have lesions with restricted diffusion. Patients with transient global amnesia may have punctate lesions with restricted diffusion in the medial hippocampus, parahippocampal gyms, and corpus callosum. (3) Vasogenic edema syndromes that may mimic acute infarction clinically and on conventional imaging. These include eclampsia/hypertensive encephalopathy, other posterior leukoencephalopathies, human immunodeficiency virus encephalopathy, hyperperfusion syndrome following carotid endarterectomy, venous sinus thrombosis, acute demyelination, and neoplasm. These syndromes demonstrate elevated diffusion rather than the restricted diffusion associated with acute ischemic stroke. (4) Entities in which restricted diffusion may resemble acute infarction. These include pyogenic infections, herpes virus encephalitis, Creutzfeldt-Jakob disease, diffuse axonal injury, tumors with dense cell packing, and rare acute demyelinative lesions.

  18. Mechanical thrombectomy in acute embolic stroke: preliminary results with the revive device.

    Rohde, Stefan; Haehnel, Stefan; Herweh, Christian; Pham, Mirko; Stampfl, Sibylle; Ringleb, Peter A; Bendszus, Martin

    2011-10-01

    The purpose of this study was to evaluate the safety and technical feasibility of a new thrombectomy device (Revive; Micrus Endovascular) in the endovascular treatment of acute ischemic stroke. Ten patients with acute large vessel occlusions were treated with the Revive device between October 2010 and December 2010. Mean National Institutes of Health Stroke Scale on admission was 19.0; mean duration of symptoms was 172 minutes. Recanalization was assessed using the Thrombolysis In Cerebral Infarction score. Clinical outcome (National Institutes of Health Stroke Scale) after thrombectomy was determined on Day 1, at discharge, and at Day 30. Vessel recanalization (Thrombolysis In Cerebral Infarction 2b or 3) was successful in all patients without device-related complications. Mean National Institutes of Health Stroke Scale 24 hours after the intervention, at discharge, and at Day 30 was 14.0, 11.5, and 5.1, respectively. At Day 30, 6 patients had a clinical improvement of >8 points or an National Institutes of Health Stroke Scale of 0 to 1, 1 patient showed minor improvement, and 3 patients had died. Symptomatic intracranial hemorrhage occurred in 2 patients, of which 1 was fatal. Thrombectomy with the Revive device in patients with stroke with acute large vessel occlusions demonstrated to be technically safe and highly effective. Clinical safety and efficacy have to be established in larger clinical trials.

  19. Regional wall movement of the left ventricle in coronary heat diseases

    Schad, N.

    1979-01-01

    The regional wall movement of the left ventriculus is a substantial criterion for the treatment of coronary heart diseases. The non-invasive and riskless intravenous injections of a bolus of Technetium 99m-Pertechnetat and the recording of the first passage through the heart allow to present the regional wall movement of the left ventriculus and, in addition, to make a statement on the haemodynamic feed back effects on lungs and the right heart. The congruency with the wall movement determined invasively, in the contrast substance angiocardiogram, is high both for the normokinesis and for hypo-, A - and dyskinesis (90-92%). The examination proved good in following groups of patients and makes the decision on the further proceding easier: 1) After myocardial infarction. 2) In ishaemia-ECG or persistent ST-elevation. 3) In unstable progressive angina pectoris. 4) In unclear breast aches and negative ECG on exertion. 5) For course control after conservative and surgial therapy. The myocardial reserve can be shown using a after nitroglycerin administration. An investigation on exertion can find out affected vessel territories in the circulation. (orig.) [de

  20. Small cardiac lesions: fibrosis of papillary muscles and focal cardiac myocytolysis

    Steer, A [Hijiyanna Park, Hiroshima JP; Nakashima, N; Kawashima, T; Lee, K K; Danzig, M D; Robertson, T L; Dock, D S

    1977-11-01

    Three types of small cardiac lesions were described and illustrated: (1) focal type of papillary muscle fibrosis, evidently a healed infarct of the papillary muscle present in 13% of the autopsies, is a histologically characteristic lesion associated with coronary artery disease and healed myocardial infarction; (2) diffuse type of papillary muscle fibrosis, probably an aging change present in almost half of the autopsies, is associated with sclerosis of the arteries in the papillary muscle, is identifiable histologically; and apparently is not associated with any cardiac abnormality; and (3) focal cardiac myocytolysis, a unique histologic lesion, usually multifocal without predilection for any area of the heart, is associated with ischemic heart disease, death due to cancer complicated by non-bacterial thrombotic endocarditis and microthrombi in small cardiac arteries as well as with other diseases. Differentiation of the 2 types of papillary muscle fibrosis is important in the study of papillary muscle and mitral valve dysfunction. Focal cardiac myocytolysis may contribute to the fatal extension of myocardial infarcts.