WorldWideScience

Sample records for clinical rationale study

  1. JAK2 inhibitor therapy in myeloproliferative disorders: rationale, preclinical studies and ongoing clinical trials.

    Science.gov (United States)

    Pardanani, A

    2008-01-01

    The recent identification of somatic mutations such as JAK2V617F that deregulate Janus kinase (JAK)-signal transducer and activator of transcription signaling has spurred development of orally bioavailable small-molecule inhibitors that selectively target JAK2 kinase as an approach to pathogenesis-directed therapy of myeloproliferative disorders (MPD). In pre-clinical studies, these compounds inhibit JAK2V617F-mediated cell growth at nanomolar concentrations, and in vivo therapeutic efficacy has been demonstrated in mouse models of JAK2V617F-induced disease. In addition, ex vivo growth of progenitor cells from MPD patients harboring JAK2V617F or MPLW515L/K mutations is also potently inhibited. JAK2 inhibitors currently in clinical trials can be grouped into those designed to primarily target JAK2 kinase (JAK2-selective) and those originally developed for non-MPD indications, but that nevertheless have significant JAK2-inhibitory activity (non-JAK2 selective). This article discusses the rationale for using JAK2 inhibitors for the treatment of MPD, as well as relevant aspects of clinical trial development for these patients. For instance, which group of MPD patients is appropriate for initial Phase I studies? Should JAK2V617F-negative MPD patients be included in the initial studies? What are the likely consequences of 'off-target' JAK3 and wild-type JAK2 inhibition? How should treatment responses be monitored?

  2. Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial.

    Science.gov (United States)

    Merkely, Bela; Kosztin, Annamaria; Roka, Attila; Geller, Laszlo; Zima, Endre; Kovacs, Attila; Boros, Andras Mihaly; Klein, Helmut; Wranicz, Jerzy K; Hindricks, Gerhard; Clemens, Marcell; Duray, Gabor Z; Moss, Arthur J; Goldenberg, Ilan; Kutyifa, Valentina

    2017-09-01

    There is lack of conclusive evidence from randomized clinical trials on the efficacy and safety of upgrade to cardiac resynchronization therapy (CRT) in patients with implanted pacemakers (PM) or defibrillators (ICD) with reduced left ventricular ejection fraction (LVEF) and chronic heart failure (HF). The BUDAPEST-CRT Upgrade Study was designed to compare the efficacy and safety of CRT upgrade from conventional PM or ICD therapy in patients with intermittent or permanent right ventricular (RV) septal/apical pacing, reduced LVEF, and symptomatic HF. The BUDAPEST-CRT study is a prospective, randomized, multicentre, investigator-sponsored clinical trial. A total of 360 subjects will be enrolled with LVEF ≤ 35%, NYHA functional classes II-IVa, paced QRS ≥ 150 ms, and a RV pacing ≥ 20%. Patients will be followed for 12 months. Randomization is performed in a 3:2 ratio (CRT-D vs. ICD). The primary composite endpoint is all-cause mortality, a first HF event, or less than 15% reduction in left ventricular (LV) end-systolic volume at 12 months. Secondary endpoints are all-cause mortality, all-cause mortality or HF event, and LV volume reduction at 12 months. Tertiary endpoints include changes in quality of life, NYHA functional class, 6 min walk test, natriuretic peptides, and safety outcomes. The results of our prospective, randomized, multicentre clinical trial will provide important information on the role of cardiac resynchronization therapy with defibrillator (CRT-D) upgrade in patients with symptomatic HF, reduced LVEF, and wide-paced QRS with intermittent or permanent RV pacing. NCT02270840. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

  3. Study design and rationale for biomedical shirt-based electrocardiography monitoring in relevant clinical situations: ECG-shirt study.

    Science.gov (United States)

    Balsam, Paweł; Lodziński, Piotr; Tymińska, Agata; Ozierański, Krzysztof; Januszkiewicz, Łukasz; Główczyńska, Renata; Wesołowska, Katarzyna; Peller, Michał; Pietrzak, Radosław; Książczyk, Tomasz; Borodzicz, Sonia; Kołtowski, Łukasz; Borkowski, Mariusz; Werner, Bożena; Opolski, Grzegorz; Grabowski, Marcin

    2018-01-01

    Today, the main challenge for researchers is to develop new technologies which may help to improve the diagnoses of cardiovascular disease (CVD), thereby reducing healthcare costs and improving the quality of life for patients. This study aims to show the utility of biomedical shirt-based electrocardiography (ECG) monitoring of patients with CVD in different clinical situations using the Nuubo® ECG (nECG) system. An investigator-initiated, multicenter, prospective observational study was carried out in a cardiology (adult and pediatric) and cardiac rehabilitation wards. ECG monitoring was used with the biomedical shirt in the following four independent groups of patients: 1) 30 patients after pulmonary vein isolation (PVI), 2) 30 cardiac resynchronization therapy (CRT) recipients, 3) 120 patients during cardiac rehabilitation after myocardial infarction, and 4) 40 pediatric patients with supraventricular tachycardia (SVT) before electrophysiology study. Approval for all study groups was obtained from the institutional review board. The biomedical shirt captures the electrocardiographic signal via textile electrodes integrated into a garment. The software allows the visualization and analysis of data such as ECG, heart rate, arrhythmia detecting algorithm and relative position of the body is captured by an electronic device. The major advantages of the nECG system are continuous ECG monitoring during daily activities, high quality of ECG recordings, as well as assurance of a proper adherence due to adequate comfort while wearing the shirt. There are only a few studies that have examined wearable systems, especially in pediatric populations. This study is registered in ClinicalTrials.gov: Identifier NCT03068169. (Cardiol J 2018; 25, 1: 52-59).

  4. International Study to Predict Optimized Treatment for Depression (iSPOT-D, a randomized clinical trial: rationale and protocol

    Directory of Open Access Journals (Sweden)

    Cooper Nicholas J

    2011-01-01

    Full Text Available Abstract Background Clinically useful treatment moderators of Major Depressive Disorder (MDD have not yet been identified, though some baseline predictors of treatment outcome have been proposed. The aim of iSPOT-D is to identify pretreatment measures that predict or moderate MDD treatment response or remission to escitalopram, sertraline or venlafaxine; and develop a model that incorporates multiple predictors and moderators. Methods/Design The International Study to Predict Optimized Treatment - in Depression (iSPOT-D is a multi-centre, international, randomized, prospective, open-label trial. It is enrolling 2016 MDD outpatients (ages 18-65 from primary or specialty care practices (672 per treatment arm; 672 age-, sex- and education-matched healthy controls. Study-eligible patients are antidepressant medication (ADM naïve or willing to undergo a one-week wash-out of any non-protocol ADM, and cannot have had an inadequate response to protocol ADM. Baseline assessments include symptoms; distress; daily function; cognitive performance; electroencephalogram and event-related potentials; heart rate and genetic measures. A subset of these baseline assessments are repeated after eight weeks of treatment. Outcomes include the 17-item Hamilton Rating Scale for Depression (primary and self-reported depressive symptoms, social functioning, quality of life, emotional regulation, and side-effect burden (secondary. Participants may then enter a naturalistic telephone follow-up at weeks 12, 16, 24 and 52. The first half of the sample will be used to identify potential predictors and moderators, and the second half to replicate and confirm. Discussion First enrolment was in December 2008, and is ongoing. iSPOT-D evaluates clinical and biological predictors of treatment response in the largest known sample of MDD collected worldwide. Trial registration International Study to Predict Optimised Treatment - in Depression (iSPOT-D ClinicalTrials.gov Identifier

  5. The National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study Cohort: Rationale, Methods, and Baseline Characteristics

    Science.gov (United States)

    Rasmussen-Torvik, Laura J; Harmata, Emily E; Pardee, Roy; Saizan, Rosalinde; Malanga, Elisha; Sturtevant, Jessica L; Horgan, Casie E; Anau, Jane; Janning, Cheri D; Wellman, Robert D; Coley, R Yates; Cook, Andrea J; Courcoulas, Anita P; Coleman, Karen J; Williams, Neely A; McTigue, Kathleen M; Arterburn, David; McClay, James

    2017-01-01

    Background Although bariatric procedures are commonly performed in clinical practice, long-term data on the comparative effectiveness and safety of different procedures on sustained weight loss, comorbidities, and adverse effects are limited, especially in important patient subgroups (eg, individuals with diabetes, older patients, adolescents, and minority patients). Objective The objective of this study was to create a population-based cohort of patients who underwent 3 commonly performed bariatric procedures—adjustable gastric band (AGB), Roux-en-Y gastric bypass (RYGB), and sleeve gastrectomy (SG)—to examine the long-term comparative effectiveness and safety of these procedures in both adults and adolescents. Methods We identified adults (20 to 79 years old) and adolescents (12 to 19 years old) who underwent a primary (first observed) AGB, RYGB, or SG procedure between January 1, 2005 and September 30, 2015 from 42 health systems participating in the Clinical Data Research Networks within the National Patient-Centered Clinical Research Network (PCORnet). We extracted information on patient demographics, encounters with healthcare providers, diagnoses recorded and procedures performed during these encounters, vital signs, and laboratory test results from patients’ electronic health records (EHRs). The outcomes of interest included weight change, incidence of major surgery-related adverse events, and diabetes remission and relapse, collected for up to 10 years after the initial bariatric procedure. Results A total of 65,093 adults and 777 adolescents met the eligibility criteria of the study. The adult subcohort had a mean age of 45 years and was predominantly female (79.30%, 51,619/65,093). Among adult patients with non-missing race or ethnicity information, 72.08% (41,248/57,227) were White, 21.13% (12,094/57,227) were Black, and 20.58% (13,094/63,637) were Hispanic. The average highest body mass index (BMI) recorded in the year prior to surgery was 49 kg

  6. Regulatory dendritic cells for promotion of liver transplant operational tolerance: Rationale for a clinical trial and accompanying mechanistic studies.

    Science.gov (United States)

    Thomson, Angus W; Humar, Abhinav; Lakkis, Fadi G; Metes, Diana M

    2018-05-01

    Dendritic cells (DC) are rare, bone marrow (BM)-derived innate immune cells that critically maintain self-tolerance in the healthy steady-state. Regulatory DC (DCreg) with capacity to suppress allograft rejection and promote transplant tolerance in pre-clinical models can readily be generated from BM precursors or circulating blood monocytes. These DCreg enhance allograft survival via various mechanisms, including promotion of regulatory T cells. In non-human primates receiving minimal immunosuppressive drug therapy (IS), infusion of DCreg of donor origin, one week before transplant, safely prolongs renal allograft survival and selectively attenuates anti-donor CD8 + memory T cell responses in the early post-transplant period. Based on these observations, and in view of the critical need to reduce patient dependence on non-specific IS agents that predispose to cardiometabolic side effects and renal insufficiency, we will conduct a first-in-human safety and preliminary efficacy study of donor-derived DCreg infusion to achieve early (18 months post-transplant) complete IS withdrawal in low-risk, living donor liver transplant recipients receiving standard-of-care IS (mycophenolate mofetil, tacrolimus and steroids). We will test the hypothesis that, although donor-derived DCreg are short-lived, they will induce robust donor-specific T cell hyporesponsiveness. We will examine immunological mechanisms by sequential analysis of blood and tissue samples, incorporating cutting-edge technologies. Copyright © 2017 American Society for Histocompatibility and Immunogenetics. Published by Elsevier Inc. All rights reserved.

  7. Rapid arc - clinical rationale and results

    International Nuclear Information System (INIS)

    Cozzi, Lucca

    2008-01-01

    The presentation will focus on the background of Intensity modulation volumetric arc therapy Rapid Arc from Varian Medical Systems aiming to highlight the technical and clinical rational also from an historical perspective to the founding pillars of fast delivery with a minimum number of arcs and a minimum number of monitor units

  8. The Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA*CER) trial: study design and rationale.

    Science.gov (United States)

    2009-09-01

    The protease-activated receptor 1 (PAR-1), the main platelet receptor for thrombin, represents a novel target for treatment of arterial thrombosis, and SCH 530348 is an orally active, selective, competitive PAR-1 antagonist. We designed TRA*CER to evaluate the efficacy and safety of SCH 530348 compared with placebo in addition to standard of care in patients with non-ST-segment elevation (NSTE) acute coronary syndromes (ACS) and high-risk features. TRA*CER is a prospective, randomized, double-blind, multicenter, phase III trial with an original estimated sample size of 10,000 subjects. Our primary objective is to demonstrate that SCH 530348 in addition to standard of care will reduce the incidence of the composite of cardiovascular death, myocardial infarction (MI), stroke, recurrent ischemia with rehospitalization, and urgent coronary revascularization compared with standard of care alone. Our key secondary objective is to determine whether SCH 530348 will reduce the composite of cardiovascular death, MI, or stroke compared with standard of care alone. Secondary objectives related to safety are the composite of moderate and severe GUSTO bleeding and clinically significant TIMI bleeding. The trial will continue until a predetermined minimum number of centrally adjudicated primary and key secondary end point events have occurred and all subjects have participated in the study for at least 1 year. The TRA*CER trial is part of the large phase III SCH 530348 development program that includes a concomitant evaluation in secondary prevention. TRA*CER will define efficacy and safety of the novel platelet PAR-1 inhibitor SCH 530348 in the treatment of high-risk patients with NSTE ACS in the setting of current treatment strategies.

  9. Mineralized Collagen: Rationale, Current Status, and Clinical Applications

    Directory of Open Access Journals (Sweden)

    Zhi-Ye Qiu

    2015-07-01

    Full Text Available This paper presents a review of the rationale for the in vitro mineralization process, preparation methods, and clinical applications of mineralized collagen. The rationale for natural mineralized collagen and the related mineralization process has been investigated for decades. Based on the understanding of natural mineralized collagen and its formation process, many attempts have been made to prepare biomimetic materials that resemble natural mineralized collagen in both composition and structure. To date, a number of bone substitute materials have been developed based on the principles of mineralized collagen, and some of them have been commercialized and approved by regulatory agencies. The clinical outcomes of mineralized collagen are of significance to advance the evaluation and improvement of related medical device products. Some representative clinical cases have been reported, and there are more clinical applications and long-term follow-ups that currently being performed by many research groups.

  10. Genetic, clinical and pharmacological determinants of out-of-hospital cardiac arrest: rationale and outline of the AmsteRdam Resuscitation Studies (ARREST) registry

    Science.gov (United States)

    Blom, M T; van Hoeijen, D A; Bardai, A; Berdowski, J; Souverein, P C; De Bruin, M L; Koster, R W; de Boer, A; Tan, H L

    2014-01-01

    Introduction Out-of-hospital cardiac arrest (OHCA) is a major public health problem. Recognising the complexity of the underlying causes of OHCA in the community, we aimed to establish the clinical, pharmacological, environmental and genetic factors and their interactions that may cause OHCA. Methods and analysis We set up a large-scale prospective community-based registry (AmsteRdam Resuscitation Studies, ARREST) in which we prospectively include all resuscitation attempts from OHCA in a large study region in the Netherlands in collaboration with Emergency Medical Services. Of all OHCA victims since June 2005, we prospectively collect medical history (through hospital and general practitioner), and current and previous medication use (through community pharmacy). In addition, we include DNA samples from OHCA victims with documented ventricular tachycardia/fibrillation during the resuscitation attempt since July 2007. Various study designs are employed to analyse the data of the ARREST registry, including case–control, cohort, case only and case-cross over designs. Ethics and dissemination We describe the rationale, outline and potential results of the ARREST registry. The design allows for a stable and reliable collection of multiple determinants of OHCA, while assuring that the patient, lay-caregiver or medical professional is not hindered in any way. Such comprehensive data collection is required to unravel the complex basis of OHCA. Results will be published in peer-reviewed journals and presented at relevant scientific symposia. PMID:25332818

  11. Rationale and design of a pilot study examining Acceptance and Commitment Therapy for persistent pain in an integrated primary care clinic.

    Science.gov (United States)

    Kanzler, Kathryn E; Robinson, Patricia J; McGeary, Donald D; Mintz, Jim; Potter, Jennifer Sharpe; Muñante, Mariana; Lopez, Eliot J; Dougherty, Donald M; Hale, Willie J; Velligan, Dawn I

    2018-03-01

    Most of the 100 million Americans with persistent pain are treated in primary care clinics, but evidence-based psychosocial approaches targeting pain-related disability are not usually provided in these settings. This manuscript describes the rationale and methods for a protocol to pilot test the feasibility and effectiveness of Acceptance and Commitment Therapy (ACT), an evidence-based psychological treatment for persistent pain, delivered by a Behavioral Health Consultant in primary care. Eligible patients are identified through electronic health record registries and invited to participate via secure messaging, letters and a follow-up phone call. Participants are also recruited with advertising and clinician referral. Patients agreeing to participate are consented and complete initial assessments, with a target of 60 participants. Randomization is stratified based on pain severity with participants assigned to either ACT or Enhanced Treatment as Usual (E-TAU). ACT participants receive one standardized Behavioral Health Consultation visit followed by three ACT-based group visits and one group booster visit. All patients attend six assessment visits, during which the E-TAU patients are provided with educational pain management handouts based on standard cognitive behavioral treatment of pain. The study aims to determine feasibility and effectiveness of brief ACT for persistent pain delivered by an integrated behavioral health clinician in primary care from pre- to post-treatment, and to examine mechanisms of change in ACT participants. This study, in a "real-world" setting, will lay groundwork for a larger trial. If effective, it could improve treatment methods and quality of life for patients with persistent pain using a scalable approach. Copyright © 2018 Elsevier Inc. All rights reserved.

  12. The Escitalopram versus Electric Current Therapy for Treating Depression Clinical Study (ELECT-TDCS: rationale and study design of a non-inferiority, triple-arm, placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    André Russowsky Brunoni

    Full Text Available CONTEXT AND OBJECTIVE: Major depressive disorder (MDD is a common psychiatric condition, mostly treated with antidepressant drugs, which are limited due to refractoriness and adverse effects. We describe the study rationale and design of ELECT-TDCS (Escitalopram versus Electric Current Therapy for Treating Depression Clinical Study, which is investigating a non-pharmacological treatment known as transcranial direct current stimulation (tDCS.DESIGN AND SETTING: Phase-III, randomized, non-inferiority, triple-arm, placebo-controlled study, ongoing in São Paulo, Brazil.METHODS: ELECT-TDCS compares the efficacy of active tDCS/placebo pill, sham tDCS/escitalopram 20 mg/day and sham tDCS/placebo pill, for ten weeks, randomizing 240 patients in a 3:3:2 ratio, respectively. Our primary aim is to show that tDCS is not inferior to escitalopram with a non-inferiority margin of at least 50% of the escitalopram effect, in relation to placebo. As secondary aims, we investigate several biomarkers such as genetic polymorphisms, neurotrophin serum markers, motor cortical excitability, heart rate variability and neuroimaging.RESULTS: Proving that tDCS is similarly effective to antidepressants would have a tremendous impact on clinical psychiatry, since tDCS is virtually devoid of adverse effects. Its ease of use, portability and low price are further compelling characteristics for its use in primary and secondary healthcare. Multimodal investigation of biomarkers will also contribute towards understanding the antidepressant mechanisms of action of tDCS.CONCLUSION: Our results have the potential to introduce a novel technique to the therapeutic arsenal of treatments for depression.

  13. Checkpoint inhibitors in endometrial cancer: preclinical rationale and clinical activity.

    Science.gov (United States)

    Mittica, Gloria; Ghisoni, Eleonora; Giannone, Gaia; Aglietta, Massimo; Genta, Sofia; Valabrega, Giorgio

    2017-10-27

    Treatment of advanced and recurrent endometrial cancer (EC) is still an unmet need for oncologists and gynecologic oncologists. The Cancer Genome Atlas Research Network (TCGA) recently provided a new genomic classification, dividing EC in four subgroups. Two types of EC, the polymerase epsilon (POLE)-ultra-mutated and the microsatellite instability-hyper-mutated (MSI-H), are characterized by a high mutation rate providing the rationale for a potential activity of checkpoint inhibitors. We analyzed all available evidence supporting the role of tumor microenvironment (TME) in EC development and the therapeutic implications offered by immune checkpoint inhibitors in this setting. We performed a review on Pubmed with Mesh keywords 'endometrial cancer' and the name of each checkpoint inhibitor discussed in the article. The same search was operated on clinicaltrial.gov to identify ongoing clinical trials exploring PD-1/PD-L1 and CTLA-4 axis in EC, particularly focusing on POLE-ultra-muted and MSI-H cancer types. POLE-ultra-mutated and MSI-H ECs showed an active TME expressing high number of neo-antigens and an elevated amount of tumor infiltrating lymphocytes (TILs). Preliminary results from a phase-1 clinical trial (KEYNOTE-028) demonstrated antitumor activity of Pembrolizumab in EC. Moreover, both Pembrolizumab and Nivolumab reported durable clinical responses in POLE-ultra-mutated patients. Immune checkpoint inhibitors are an attractive option in POLE-ultra-mutated and MSI-H ECs. Future investigations in these subgroups include combinations of checkpoints inhibitors with chemotherapy and small tyrosine kinase inhibitors (TKIs) to enhance a more robust intra-tumoral immune response.

  14. Rationale and Design of the 'MITOCARE' Study

    DEFF Research Database (Denmark)

    Clemmensen, Peter

    2012-01-01

    resonance). The study is being financed under an EU-FP7 grant and conducted under the auspices of the MITOCARE research consortium, which includes experts from clinical and basic research centers, as well as commercial enterprises, throughout Europe. Results from this study will contribute to a better...

  15. Managed ventricular pacing vs. conventional dual-chamber pacing for elective replacements: the PreFER MVP study: clinical background, rationale, and design.

    Science.gov (United States)

    Quesada, Aurelio; Botto, Gianluca; Erdogan, Ali; Kozak, Milan; Lercher, Peter; Nielsen, Jens Cosedis; Piot, Olivier; Ricci, Renato; Weiss, Christian; Becker, Daniel; Wetzels, Gwenn; De Roy, Luc

    2008-03-01

    Several clinical studies have shown that, in patients with intact atrioventricular (AV) conduction, unnecessary chronic right ventricular (RV) pacing can be detrimental. The managed ventricular pacing (MVP) algorithm is designed to give preference to spontaneous AV conduction, thus minimizing RV pacing. The clinical outcomes of MVP are being studied in several ongoing trials in patients undergoing a first device implantation, but it is unknown to what extent MVP is beneficial in patients with a history of ventricular pacing. The purpose of the Prefer for Elective Replacement MVP (PreFER MVP) study is to assess the superiority of the MVP algorithm to conventional pacemaker and implantable cardioverter-defibrillator programming in terms of freedom from hospitalization for cardiovascular causes in a population of patients exposed to long periods of ventricular pacing. PreFER MVP is a prospective, 1:1 parallel, randomized (MVP ON/MVP OFF), single-blinded multi-centre trial. The study population consists of patients with more than 40% ventricular pacing documented with their previous device. Approximately, 600 patients will be randomized and followed for at least 24 months. The primary endpoint comprises cardiovascular hospitalization. The PreFER MVP trial is the first large prospective randomized clinical trial evaluating the effect of MVP in patients with a history of RV pacing.

  16. Rationale, design, and cohort enrolment of a prospective observational study of the clinical performance of the new contraceptive implant (Femplant) in Pakistan.

    Science.gov (United States)

    Azmat, Syed Khurram; Hameed, Waqas; Lendvay, Anja; Shaikh, Babar Tasneem; Mustafa, Ghulam; Siddiqui, Muhammad Ahmed; Brohi, Sajid; Karim, Asif; Ishaque, Muhammad; Hussain, Wajahat; Bilgrami, Mohsina; Feldblum, Paul J

    2014-01-01

    The use of hormonal implants has gained positive traction in family planning programs in recent times. Compared to other popular methods, such as long-term reversible intrauterine devices, the use of hormonal implants as a family planning method has distinct advantages in terms of long-term efficiency and better user compliance and availability. This paper presents a study protocol to document and evaluate the efficacy, safety, and acceptability of Femplant (contraceptive implant) in Pakistan during the first year of its use among married women of reproductive age (18-44 years) at clinics in two provinces of Pakistan (Sindh and Punjab). A total of 724 married women were enrolled in a noncomparative prospective observational study. The study involved six government clinics from the Population Welfare Department in Sindh Province and 13 clinics run by the Marie Stopes Society (a local nongovernmental organization) in both provinces. The participation of women was subject to voluntary acceptance and medical eligibility. All respondents were interviewed at baseline and subsequently at each scheduled visit during the study period. Side effects, complications and adverse events, if any, were recorded for every participant at each visit to the facility. Over the next 5-year period (2013-2018), 27 million hormonal implants will be made available in lower- to middle-income countries by international donors and agencies. The evidence generated from this study will identify factors affecting the acceptability and satisfaction of end users with Femplant (Sino-implant II). This will help to guide policies to enhance access to and the use of long-acting contraceptive implants in Pakistan and similar developing countries.

  17. Rationale, design, and cohort enrolment of a prospective observational study of the clinical performance of the new contraceptive implant (Femplant in Pakistan

    Directory of Open Access Journals (Sweden)

    Azmat SK

    2014-05-01

    Full Text Available Syed Khurram Azmat,1 Waqas Hameed,1 Anja Lendvay,2 Babar Tasneem Shaikh,3 Ghulam Mustafa,1 Muhammad Ahmed Siddiqui,1 Sajid Brohi,1 Asif Karim,1 Muhammad Ishaque,1 Wajahat Hussain,1 Mohsina Bilgrami,1 Paul J Feldblum2 1Research, Monitoring and Evaluation Department, Marie Stopes Society, Karachi, Pakistan; 2FHI 360, Durham, NC, USA; 3Health Services Academy, Islamabad, Pakistan Introduction: The use of hormonal implants has gained positive traction in family planning programs in recent times. Compared to other popular methods, such as long-term reversible intrauterine devices, the use of hormonal implants as a family planning method has distinct advantages in terms of long-term efficiency and better user compliance and availability. This paper presents a study protocol to document and evaluate the efficacy, safety, and acceptability of Femplant (contraceptive implant in Pakistan during the first year of its use among married women of reproductive age (18–44 years at clinics in two provinces of Pakistan (Sindh and Punjab. Materials and methods: A total of 724 married women were enrolled in a noncomparative prospective observational study. The study involved six government clinics from the Population Welfare Department in Sindh Province and 13 clinics run by the Marie Stopes Society (a local nongovernmental organization in both provinces. The participation of women was subject to voluntary acceptance and medical eligibility. All respondents were interviewed at baseline and subsequently at each scheduled visit during the study period. Side effects, complications and adverse events, if any, were recorded for every participant at each visit to the facility. Discussion: Over the next 5-year period (2013–2018, 27 million hormonal implants will be made available in lower- to middle-income countries by international donors and agencies. The evidence generated from this study will identify factors affecting the acceptability and satisfaction of end

  18. Genomewide Association Studies: History, Rationale, and Prospects for Psychiatric Disorders

    NARCIS (Netherlands)

    Cichon, S.; Craddock, N.; Daly, M.J.; Faraone, S.V.; Gejman, P.V.; Kelsoe, J.; Lehner, T.; Levinson, D.F.; Moran, A.P.; Sklar, P.; Sullivan, P.F.; Boomsma, D.I.; de Geus, E.J.C.; Posthuma, D.; Willemsen, G.

    2009-01-01

    Objective: The authors conducted a review of the history and empirical basis of genomewide association studies (GWAS), the rationale for GWAS of psychiatric disorders, results to date, limitations, and plans for GWAS meta-analyses. Method: A literature review was carried out, power and other issues

  19. Genomewide association studies: history, rationale, and prospects for psychiatric disorders.

    NARCIS (Netherlands)

    Franke, B.; Buitelaar, J.K.; Cichon, S.; Craddock, N.; Daly, M.; Faraone, S.V.; Gejman, P.V.; Kelsoe, J.; Lehner, T.; Levinson, D.F.; Moran, A.; Sklar, P.; Sullivan, P.F.

    2009-01-01

    OBJECTIVE: The authors conducted a review of the history and empirical basis of genomewide association studies (GWAS), the rationale for GWAS of psychiatric disorders, results to date, limitations, and plans for GWAS meta-analyses. METHOD: A literature review was carried out, power and other issues

  20. Rationale and study design of a clinical trial to assess the effects of LDL apheresis on proteinuria in diabetic patients with severe proteinuria and dyslipidemia.

    Science.gov (United States)

    Wada, Takashi; Muso, Eri; Maruyama, Shoichi; Hara, Akinori; Furuichi, Kengo; Yoshimura, Kenichi; Miyazaki, Mariko; Sato, Eiichi; Abe, Masanori; Shibagaki, Yugo; Narita, Ichiei; Yokoyama, Hitoshi; Mori, Noriko; Yuzawa, Yukio; Matsubara, Takeshi; Tsukamoto, Tatsuo; Wada, Jun; Ito, Takafumi; Masutani, Kosuke; Tsuruya, Kazuhiko; Fujimoto, Shoichi; Tsuda, Akihiro; Suzuki, Hitoshi; Kasuno, Kenji; Terada, Yoshio; Nakata, Takeshi; Iino, Noriaki; Kobayashi, Shuzo

    2018-06-01

    Diabetic nephropathy is a leading cause of end-stage kidney disease in the world. Although various types of treatment for diabetes, hypertension and dyslipidemia have improved prognosis and quality of life in patients with diabetic nephropathy, there still exist some diabetic patients with severe proteinuria showing poor prognosis. This clinical trial, LICENSE, aims to confirm the impact of LDL apheresis on proteinuria exhibiting hyporesponsiveness to treatment. This ongoing trial is a multicenter, prospective study of diabetic patients with severe proteinuria. The objective is to examine the impact of LDL apheresis on proteinuria in patients with diabetic nephropathy. The other subject is to investigate safety of LDL apheresis in these patients. The subjects consist of diabetic patients with serum creatinine (Cr) levels below 2 mg/dL who present severe proteinuria above 3 g/g Cr or 3 g/day and LDL cholesterol above 120 mg/dL. The target number of registered patients will be 35 patients. Urinary protein excretion and renal function will be observed for 24 weeks after the treatment of LDL apheresis. This study will determine the effectiveness and safety of LDL apheresis for diabetic nephropathy patients with severe proteinuria and dyslipidemia.

  1. The Living Donor Lost Wages Trial: Study Rationale and Protocol.

    Science.gov (United States)

    Rodrigue, James R; Fleishman, Aaron; Carroll, Michaela; Evenson, Amy R; Pavlakis, Martha; Mandelbrot, Didier A; Baliga, Prabhakar; Howard, David H; Schold, Jesse D

    2018-03-01

    This paper describes the background, rationale, and design of an NIH-funded, single-center study to test the impact of offering reimbursement for donor lost wages incurred during the post-nephrectomy recovery period on the live donor kidney transplant (LDKT) rate in newly evaluated kidney transplant candidates, to examine whether offering reimbursement for donor lost wages reduces racial disparity in LDKT rates, and to determine whether higher reimbursement amounts lead to higher LDKT rates. LDKT is the optimal treatment for renal failure. However, living kidney donation has declined in the past decade, particularly among men, younger adults, blacks, and low-income adults. There is evidence that donation-related costs may deter both transplant candidates and potential donors from considering LDKT. Lost wages is a major source of financial loss for some living donors and, unlike travel and lodging expenses, is not reimbursed by financial assistance programs. The study addresses the transplant community's call to reduce the financial burden of living donation and examine its impact on LDKT rates. Findings have the potential to influence policy, clinical practice, LDKT access, and income-related and racial disparities in LDKT and living donation.

  2. Genetic, clinical and pharmacological determinants of out-of-hospital cardiac arrest : rationale and outline of the AmsteRdam Resuscitation Studies (ARREST) registry

    NARCIS (Netherlands)

    Blom, M T; van Hoeijen, D A; Bardai, A; Berdowski, J; Souverein, P C; De Bruin, M L; Koster, R W; de Boer, A; Tan, H L

    2014-01-01

    INTRODUCTION: Out-of-hospital cardiac arrest (OHCA) is a major public health problem. Recognising the complexity of the underlying causes of OHCA in the community, we aimed to establish the clinical, pharmacological, environmental and genetic factors and their interactions that may cause OHCA.

  3. Applying self-determination theory for improved understanding of physiotherapists' rationale for using research in clinical practice: a qualitative study in Sweden.

    Science.gov (United States)

    Dannapfel, Petra; Peolsson, Anneli; Ståhl, Christian; Öberg, Birgitta; Nilsen, Per

    2014-01-01

    Physiotherapists are generally positive to evidence-based practice (EBP) and the use of research in clinical practice, yet many still base clinical decisions on knowledge obtained during their initial education and/or personal experience. Our aim was to explore motivations behind physiotherapists' use of research in clinical practice. Self-Determination Theory was applied to identify the different types of motivation for use of research. This theory posits that all behaviours lie along a continuum of relative autonomy, reflecting the extent to which a person endorses their actions. Eleven focus group interviews were conducted, involving 45 physiotherapists in various settings in Sweden. Data were analysed using qualitative content analysis and the findings compared with Self-Determination Theory using a deductive approach. Motivations underlying physiotherapists use of research in clinical practice were identified. Most physiotherapists expressed autonomous forms of motivation for research use, but some exhibited more controlled motivation. Several implications about how more evidence-based physiotherapy can be achieved are discussed, including the potential to tailor educational programs on EBP to better account for differences in motivation among participants, using autonomously motivated physiotherapists as change agents and creating favourable conditions to encourage autonomous motivation by way of feelings of competence, autonomy and a sense of relatedness.

  4. Achievement of recommended glucose and blood pressure targets in patients with type 2 diabetes and hypertension in clinical practice – study rationale and protocol of DIALOGUE

    Directory of Open Access Journals (Sweden)

    Gitt Anselm K

    2012-12-01

    Full Text Available Abstract Background Patients with type 2 diabetes have 2–4 times greater risk for cardiovascular morbidity and mortality than those without, and this is even further aggravated if they also suffer from hypertension. Unfortunately, less than one third of hypertensive diabetic patients meet blood pressure targets, and more than half fail to achieve target HbA1c values. Thus, appropriate blood pressure and glucose control are of utmost importance. Since treatment sometimes fails in clinical practice while clinical trials generally suggest good efficacy, data from daily clinical practice, especially with regard to the use of newly developed anti-diabetic and anti-hypertensive compounds in unselected patient populations, are essential. The DIALOGUE registry aims to close this important gap by evaluating different treatment approaches in hypertensive type 2 diabetic patients with respect to their effectiveness and tolerability and their impact on outcomes. In addition, DIALOGUE is the first registry to determine treatment success based on the new individualized treatment targets recommended by the ADA and the EASD. Methods DIALOGUE is a prospective observational German multicentre registry and will enrol 10,000 patients with both diabetes and hypertension in up to 700 sites. After a baseline visit, further documentations are scheduled at 6, 12 and 24 months. There are two co-primary objectives referring to the most recent guidelines for the treatment of diabetes and hypertension: 1 individual HbA1c goal achievement with respect to anti-diabetic pharmacotherapy and 2 individual blood pressure goal achievement with different antihypertensive treatments. Among the secondary objectives the rate of major cardio-vascular and cerebro-vascular events (MACCE and the rate of hospitalizations are the most important. Conclusion The registry will be able to gain insights into the reasons for the obvious gap between the demonstrated efficacy and safety of anti

  5. Rationale and clinical data supporting nutritional intervention in Alzheimer's disease.

    Science.gov (United States)

    Engelborghs, S; Gilles, C; Ivanoiu, A; Vandewoude, M

    2014-01-01

    Adequate nutrition plays an important role in the maintenance of cognitive function, particularly during aging. Malnutrition is amongst the risk factors for developing mild cognitive impairment (MCI) and Alzheimer's disease (AD). Epidemiological studies have associated deficiencies in some nutrients with a higher risk of cognitive dysfunction and/or AD. Cognitive decline in AD is correlated with synaptic loss and many of the components required to maintain optimal synaptic function are derived from dietary sources. As synapses are part of the neuronal membrane and are continuously being remodelled, the availability of sufficient levels of nutritional precursors (mainly uridine monophosphate, choline and omega-3 fatty acids) to make the phospholipids required to build neuronal membranes may have beneficial effects on synaptic degeneration in AD. In addition, B-vitamins, phospholipids and other micronutrients act as cofactors to enhance the supply of precursors required to make neuronal membranes and synapses. Despite this, no randomized controlled trial has hitherto provided evidence that any single nutrient has a beneficial effect on cognition or lowers the risk for AD. However, a multi-target approach using combinations of (micro)nutrients might have beneficial effects on cognitive function in neurodegenerative brain disorders like AD leading to synaptic degeneration. Here we review the clinical evidence for supplementation, based on a multi-target approach with a focus on key nutrients with a proposed role in synaptic dysfunction. Based on preclinical evidence, a nutrient mixture, Souvenaid(®) (Nutricia N.V., Zoetermeer, The Netherlands) was developed. Clinical trials with Souvenaid(®) have shown improved memory performance in patients with mild AD. Further clinical trials to evaluate the effects of nutritional intervention in MCI and early dementia due to AD are on-going.

  6. [Anatomic rationale for clinical efficacy of intraosseous mental nerve anesthesia].

    Science.gov (United States)

    Rabinovich, S A; Vasil'ev, Yu L; Kuzin, A N

    2018-01-01

    The aim of the study was to prove the anatomical and clinical effectiveness of the modified anesthesia of mental nerve. The effectiveness of conductive anesthesia near the mental foramen was objectively evaluated using the electric pulp test (EPT) in 100 volunteers of both sexes, aged 35-43 years. Wet anterior mandible preparations obtained from 350 cadavers aged 18-74 years were also studied. EPT value after local mental anesthesia conducted according to Malamed C. using 4% articain solution of local anesthetic with vasoconstrictor concentration of 1:200.000 after 2 minutes was 93±0.82 mA, after 4 minutes - 188±1.26 mA. Yield variability indicators of intraosseous mental nerve anesthesia was slightly higher varying from 94.11 mA to 96.61 mA after 2 minutes and from 197.4 to 199.92 mA after 4 minutes survey. The study showed the efficiency and predictability of intraosseous anesthesia of the mental nerve.

  7. Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol.

    Science.gov (United States)

    Heatley, Gerald; Sood, Poornima; Goldstein, Daniel; Uriel, Nir; Cleveland, Joseph; Middlebrook, Don; Mehra, Mandeep R

    2016-04-01

    The HeartMate 3 left ventricular assist system (LVAS; St. Jude Medical, Inc., formerly Thoratec Corporation, Pleasanton, CA) was recently introduced into clinical trials for durable circulatory support in patients with medically refractory advanced-stage heart failure. This centrifugal, fully magnetically levitated, continuous-flow pump is engineered with the intent to enhance hemocompatibility and reduce shear stress on blood elements, while also possessing intrinsic pulsatility. Although bridge-to-transplant (BTT) and destination therapy (DT) are established dichotomous indications for durable left ventricular assist device (LVAD) support, clinical practice has challenged the appropriateness of these designations. The introduction of novel LVAD technology allows for the development of clinical trial designs to keep pace with current practices. The prospective, randomized Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) clinical trial aims to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HeartMate II LVAS (also St. Jude Medical, Inc.). The innovative trial design includes patients enrolled under a single inclusion and exclusion criteria , regardless of the intended use of the device, with outcomes ascertained in the short term (ST, at 6 months) and long term (LT, at 2 years). This adaptive trial design includes a pre-specified safety phase (n = 30) analysis. The ST cohort includes the first 294 patients and the LT cohort includes the first 366 patients for evaluation of the composite primary end-point of survival to transplant, recovery or LVAD support free of debilitating stroke (modified Rankin score >3), or re-operation to replace the pump. As part of the adaptive design, an analysis by an independent statistician will determine whether sample size adjustment is required at pre-specified times during the study. A further 662

  8. Measurement of leukocyte rheology in vascular disease: clinical rationale and methodology. International Society of Clinical Hemorheology.

    Science.gov (United States)

    Wautier, J L; Schmid-Schönbein, G W; Nash, G B

    1999-01-01

    The measurement of leukocyte rheology in vascular disease is a recent development with a wide range of new opportunities. The International Society of Clinical Hemorheology has asked an expert panel to propose guidelines for the investigation of leukocyte rheology in clinical situations. This article first discusses the mechanical, adhesive and related functional properties of leukocytes (especially neutrophils) which influence their circulation, and establishes the rationale for clinically-related measurements of parameters which describe them. It is concluded that quantitation of leukocyte adhesion molecules, and of their endothelial receptors may assist understanding of leukocyte behaviour in vascular disease, along with measurements of flow resistance of leukocytes, free radical production, degranulation and gene expression. For instance, vascular cell adhesion molecule (VCAM-1) is abnormally present on endothelial cells in atherosclerosis, diabetes mellitus and inflammatory conditions. Soluble forms of intercellular adhesion molecule (ICAM-1) or VCAM can be found elevated in the blood of patients with rheumatoid arthritis or infections disease. In the second part of the article, possible technical approaches are presented and possible avenues for leukocyte rheological investigations are discussed.

  9. Targeting dormant micrometastases: rationale, evidence to date and clinical implications.

    Science.gov (United States)

    Hurst, Robert E; Bastian, Anja; Bailey-Downs, Lora; Ihnat, Michael A

    2016-03-01

    In spite of decades of research, cancer survival has increased only modestly. This is because most research is based on models of primary tumors. Slow recognition has begun that disseminated, dormant cancer cells (micrometastatic cells) that are generally resistant to chemotherapy are the culprits in recurrence, and until these are targeted effectively we can expect only slow progress in increasing overall survival from cancer. This paper reviews efforts to understand the mechanisms by which cancer cells can become dormant, and thereby identify potential targets and drugs either on the market or in clinical trials that purport to prevent metastasis. This review targets the most recent literature because several excellent reviews have covered the literature from more than two years ago. The paper also describes recent work in the authors' laboratories to develop a screening-based approach that does not require understanding of mechanisms of action or the molecular target. Success of this approach shows that targeting micrometastatic cells is definitely feasible.

  10. Multiple daily fractionation in radiotherapy: biological rationale and preliminary clinical experiences

    Energy Technology Data Exchange (ETDEWEB)

    Arcangeli, G [Instituto Medico Scientifico, Rome (Italy). Dept. of Oncology; Mauro, F; Morelli, D; Nervi, C

    1979-09-01

    The biological bases of radiation dose fractionation are reviewed and discussed with special emphasis on reassortment. Experimental data on animal model systems are presented to clarify that reassortment has to be added to sublethal damage repair and reoxygenation in the rationale for an optimized radiotherapy course according to tumor cell kinetics. Clinical results on several human tumors treated with twice or thrice daily fractions are described. These results show that some clinically radioresistant tumors (especially if not characterized by a relatively long clinical doubling line) can be satisfactorily dealt with using multiple daily fractionation. Clinical observations indicate that a relatively high cumulative daily dose (200 + 150 + 150 rad) can be safely administered.

  11. Coupled plasma filtration adsorption: rationale, technical development and early clinical experience.

    Science.gov (United States)

    Ronco, Claudio; Brendolan, Alessandra; d'Intini, Vincenzo; Ricci, Zaccaria; Wratten, Mary Lou; Bellomo, Rinaldo

    2003-01-01

    The adjuvant treatment of sepsis remains a major therapeutic challenge. Blood purification is theoretically appealing if the humoral theory of sepsis is accepted as the basis for intervention. In this setting, blood purification would provide a broad-based restoration of humoral homeostasis thereby avoiding both excessive inflammation and counterinflammation. Several techniques of blood purification have been tried or are under active investigation. One of these is the so-called coupled plasma filtration adsorption (CPFA). CPFA is a novel extracorporeal blood purification therapy aimed at nonselectively reducing the circulating levels and activities of both pro- and anti-inflammatory mediators during sepsis and multiorgan failure. In vitro studies have shown CPFA to be effective in binding a broad range of such mediators proving its technical efficacy. Subsequent animal models have shown a beneficial effect on survival in endotoxemia. These studies have provided the necessary technical developments and biologic rationale for initial human studies. Two phase I/IIa clinical studies have now been performed. Both studies have shown that CPFA improves blood pressure and restores immune function in patients with severe sepsis and multiorgan dysfunction. In this article, we will discuss some of the basic principles involved in sorbent technology, and how these may contribute to treatment efficacy, review animal experiments with CPFA and finally discuss the results of recent human studies and their implications. Copyright 2003 S. Karger AG, Basel

  12. A cluster randomized trial to assess the impact of clinical pathways for patients with stroke: rationale and design of the Clinical Pathways for Effective and Appropriate Care Study [NCT00673491

    Directory of Open Access Journals (Sweden)

    Barbieri Antonella

    2008-11-01

    Full Text Available Abstract Background Patients with stroke should have access to a continuum of care from organized stroke units in the acute phase, to appropriate rehabilitation and secondary prevention measures. Moreover to improve the outcomes for acute stroke patients from an organizational perspective, the use of multidisciplinary teams and the delivery of continuous stroke education both to the professionals and to the public, and the implementation of evidence-based stroke care are recommended. Clinical pathways are complex interventions that can be used for this purpose. However in stroke care the use of clinical pathways remains questionable because little prospective controlled data has demonstrated their effectiveness. The purpose of this study is to determine whether clinical pathways could improve the quality of the care provided to the patients affected by stroke in hospital and through the continuum of the care. Methods Two-arm, cluster-randomized trial with hospitals and rehabilitation long-term care facilities as randomization units. 14 units will be randomized either to arm 1 (clinical pathway or to arm 2 (no intervention, usual care. The sample will include 238 in each group, this gives a power of 80%, at 5% significance level. The primary outcome measure is 30-days mortality. The impact of the clinical pathways along the continuum of care will also be analyzed by comparing the length of hospital stay, the hospital re-admissions rates, the institutionalization rates after hospital discharge, the patients' dependency levels, and complication rates. The quality of the care provided to the patients will be assessed by monitoring the use of diagnostic and therapeutic procedures during hospital stay and rehabilitation, and by the use of key quality indicators at discharge. The implementation of organized care will be also evaluated. Conclusion The management of patients affected by stroke involves the expertise of several professionals, which can

  13. The Danish Alzheimer Intervention Study: Rationale, Study Design and Baseline Characteristics of the Cohort

    DEFF Research Database (Denmark)

    Waldemar, G.; Waldorff, F.B.; Buss, D.V.

    2011-01-01

    There is a lack of appropriately designed trials investigating the efficacy of psychosocial interventions for patients with mild dementia and their family caregivers. This paper reports the rationale and design of the Danish Alzheimer Disease Intervention Study and baseline characteristics...

  14. Data book: Space station/base food system study. Book 3: Study selection rationale sheets

    Science.gov (United States)

    1970-01-01

    The supporting rationale sheets are presented which were utilized in the selection and support of the concepts considered in the final phase of the study. Each concept, conceived to fulfill a specific function of the food system, was assessed in terms of the eight critical factors depicted on the rationale sheet. When weighted and totaled, the resulting selection factor was used as a guide in making the final decision.

  15. PET/CT-guided interventional procedures: rationale, justification, initial study, and research plan

    Energy Technology Data Exchange (ETDEWEB)

    Wong, K.; Rahill, J.; Cleary, K. [Computer Aided Interventions and Medical Robotics (CAIMR), Imaging Science and Information Systems (ISIS) Center, Georgetown Univ. Medical Center, Washington, DC (United States); Petrillo, S.; Earl-Graef, D. [Dept. of Radiology, Georgetown Univ. Hospital, MedStar Health, Washington, DC (United States); Banovac, F.; Levy, E. [Computer Aided Interventions and Medical Robotics (CAIMR), Imaging Science and Information Systems (ISIS) Center, Georgetown Univ. Medical Center, Washington, DC (United States); Dept. of Radiology, Georgetown Univ. Hospital, MedStar Health, Washington, DC (United States); Shekhar, R. [Dept. of Radiology, Univ. of Maryland Medical Center, Baltimore, MD (United States)

    2007-06-15

    Positron-emission tomography (PET) and PET/CT (computed tomography) are becoming increasingly important for diagnosis and treatment of cancer. Clinically relevant changes can sometimes be seen on PET that are not seen on other imaging modalities. However, PET is not suitable for guiding biopsy as the images are not obtained in real-time. Therefore, our research group has begun developing a concept for PET/CT-guided interventional procedures. This paper presents the rationale for this concept, outlines our research plan, and includes an initial study to evaluate the relative sensitivity of CT and PET/CT in detecting suspicious lesions. (orig.)

  16. Cognitive Defusion versus Thought Distraction: A Clinical Rationale, Training, and Experiential Exercise in Altering Psychological Impacts of Negative Self-Referential Thoughts

    Science.gov (United States)

    Masuda, Akihiko; Feinstein, Amanda B.; Wendell, Johanna W.; Sheehan, Shawn T.

    2010-01-01

    Using two modes of intervention delivery, the present study compared the effects of a cognitive defusion strategy with a thought distraction strategy on the emotional discomfort and believability of negative self-referential thoughts. One mode of intervention delivery consisted of a clinical rationale and training (i.e., Partial condition). The…

  17. Proton therapy for head and neck cancer: Rationale, potential indications, practical considerations, and current clinical evidence

    International Nuclear Information System (INIS)

    Mendenhall, Nancy P.; Malyapa, Robert S.; Su, Zhong; Yeung, Daniel; Mendenhall, William M.; Li, Zuofeng

    2011-01-01

    There is a strong rationale for potential benefits from proton therapy (PT) for selected cancers of the head and neck because of the opportunity to improve the therapeutic ratio by improving radiation dose distributions and because of the significant differences in radiation dose distribution achievable with x-ray-based radiation therapy (RT) and PT. Comparisons of dose distributions between x-ray-based and PT plans in selected cases show specific benefits in dose distribution likely to translate into improved clinical outcomes. However, the use of PT in head and neck cancers requires special considerations in the simulation and treatment planning process, and currently available PT technology may not permit realization of the maximum potential benefits of PT. To date, few clinical data are available, but early clinical experiences in sinonasal tumors in particular suggest significant improvements in both disease control and radiation-related toxicity

  18. Proton therapy for head and neck cancer: Rationale, potential indications, practical considerations, and current clinical evidence

    Energy Technology Data Exchange (ETDEWEB)

    Mendenhall, Nancy P.; Malyapa, Robert S.; Su, Zhong; Yeung, Daniel; Mendenhall, William M.; Li, Zuofeng (Univ. of Florida Proton Therapy Inst., Jacksonville, Florida (United States)), e-mail: menden@shands.ufl.edu

    2011-08-15

    There is a strong rationale for potential benefits from proton therapy (PT) for selected cancers of the head and neck because of the opportunity to improve the therapeutic ratio by improving radiation dose distributions and because of the significant differences in radiation dose distribution achievable with x-ray-based radiation therapy (RT) and PT. Comparisons of dose distributions between x-ray-based and PT plans in selected cases show specific benefits in dose distribution likely to translate into improved clinical outcomes. However, the use of PT in head and neck cancers requires special considerations in the simulation and treatment planning process, and currently available PT technology may not permit realization of the maximum potential benefits of PT. To date, few clinical data are available, but early clinical experiences in sinonasal tumors in particular suggest significant improvements in both disease control and radiation-related toxicity

  19. Study design and rationale of "Synergistic Effect of Combination Therapy with Cilostazol and ProbUcol on Plaque Stabilization and Lesion REgression (SECURE" study: a double-blind randomised controlled multicenter clinical trial

    Directory of Open Access Journals (Sweden)

    Lee Myoungsook

    2011-01-01

    Full Text Available Abstract Background Probucol, a cholesterol-lowering agent that paradoxically also lowers high-density lipoprotein cholesterol has been shown to prevent progression of atherosclerosis. The antiplatelet agent cilostazol, which has diverse antiatherogenic properties, has also been shown to reduce restenosis in previous clinical trials. Recent experimental studies have suggested potential synergy between probucol and cilostazol in preventing atherosclerosis, possibly by suppressing inflammatory reactions and promoting cholesterol efflux. Methods/design The Synergistic Effect of combination therapy with Cilostazol and probUcol on plaque stabilization and lesion REgression (SECURE study is designed as a double-blind, randomised, controlled, multicenter clinical trial to investigate the effect of cilostazol and probucol combination therapy on plaque volume and composition in comparison with cilostazol monotherapy using intravascular ultrasound and Virtual Histology. The primary end point is the change in the plaque volume of index intermediate lesions between baseline and 9-month follow-up. Secondary endpoints include change in plaque composition, neointimal growth after implantation of stents at percutaneous coronary intervention target lesions, and serum levels of lipid components and biomarkers related to atherosclerosis and inflammation. A total of 118 patients will be included in the study. Discussion The SECURE study will deliver important information on the effects of combination therapy on lipid composition and biomarkers related to atherosclerosis, thereby providing insight into the mechanisms underlying the prevention of atherosclerosis progression by cilostazol and probucol. Trial registration number ClinicalTrials (NCT: NCT01031667

  20. Design and rationale for examining neuroimaging genetics in ischemic stroke: The MRI-GENIE study.

    Science.gov (United States)

    Giese, Anne-Katrin; Schirmer, Markus D; Donahue, Kathleen L; Cloonan, Lisa; Irie, Robert; Winzeck, Stefan; Bouts, Mark J R J; McIntosh, Elissa C; Mocking, Steven J; Dalca, Adrian V; Sridharan, Ramesh; Xu, Huichun; Frid, Petrea; Giralt-Steinhauer, Eva; Holmegaard, Lukas; Roquer, Jaume; Wasselius, Johan; Cole, John W; McArdle, Patrick F; Broderick, Joseph P; Jimenez-Conde, Jordi; Jern, Christina; Kissela, Brett M; Kleindorfer, Dawn O; Lemmens, Robin; Lindgren, Arne; Meschia, James F; Rundek, Tatjana; Sacco, Ralph L; Schmidt, Reinhold; Sharma, Pankaj; Slowik, Agnieszka; Thijs, Vincent; Woo, Daniel; Worrall, Bradford B; Kittner, Steven J; Mitchell, Braxton D; Rosand, Jonathan; Golland, Polina; Wu, Ona; Rost, Natalia S

    2017-10-01

    To describe the design and rationale for the genetic analysis of acute and chronic cerebrovascular neuroimaging phenotypes detected on clinical MRI in patients with acute ischemic stroke (AIS) within the scope of the MRI-GENetics Interface Exploration (MRI-GENIE) study. MRI-GENIE capitalizes on the existing infrastructure of the Stroke Genetics Network (SiGN). In total, 12 international SiGN sites contributed MRIs of 3,301 patients with AIS. Detailed clinical phenotyping with the web-based Causative Classification of Stroke (CCS) system and genome-wide genotyping data were available for all participants. Neuroimaging analyses include the manual and automated assessments of established MRI markers. A high-throughput MRI analysis pipeline for the automated assessment of cerebrovascular lesions on clinical scans will be developed in a subset of scans for both acute and chronic lesions, validated against gold standard, and applied to all available scans. The extracted neuroimaging phenotypes will improve characterization of acute and chronic cerebrovascular lesions in ischemic stroke, including CCS subtypes, and their effect on functional outcomes after stroke. Moreover, genetic testing will uncover variants associated with acute and chronic MRI manifestations of cerebrovascular disease. The MRI-GENIE study aims to develop, validate, and distribute the MRI analysis platform for scans acquired as part of clinical care for patients with AIS, which will lead to (1) novel genetic discoveries in ischemic stroke, (2) strategies for personalized stroke risk assessment, and (3) personalized stroke outcome assessment.

  1. Coronary diet intervention with olive oil and cardiovascular prevention study (the CORDIOPREV study); rationale, methods, and baseline characteristics: a clinical trial comparing the efficacy of a Mediterranean diet rich...

    Science.gov (United States)

    Coronary heart disease (CHD) represents a major global health burden. However, despite the well-known influence that dietary habits exert over the progression of this disease, there are no well-established and scientifically sound dietary approaches to prevent the onset of clinical outcomes in secon...

  2. The dissociative subtype of posttraumatic stress disorder: rationale, clinical and neurobiological evidence, and implications.

    Science.gov (United States)

    Lanius, Ruth A; Brand, Bethany; Vermetten, Eric; Frewen, Paul A; Spiegel, David

    2012-08-01

    Clinical and neurobiological evidence for a dissociative subtype of posttraumatic stress disorder (PTSD) has recently been documented. A dissociative subtype of PTSD is being considered for inclusion in the forthcoming Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) to address the symptoms of depersonalization and derealization found among a subset of patients with PTSD. This article reviews research related to the dissociative subtype including antecedent, concurrent, and predictive validators as well as the rationale for recommending the dissociative subtype. The relevant literature pertaining to the dissociative subtype of PTSD was reviewed. Latent class analyses point toward a specific subtype of PTSD consisting of symptoms of depersonalization and derealization in both veteran and civilian samples of PTSD. Compared to individuals with PTSD, those with the dissociative subtype of PTSD also exhibit a different pattern of neurobiological response to symptom provocation as well as a differential response to current cognitive behavioral treatment designed for PTSD. We recommend that consideration be given to adding a dissociative subtype of PTSD in the revision of the DSM. This facilitates more accurate analysis of different phenotypes of PTSD, assist in treatment planning that is informed by considering the degree of patients' dissociativity, will improve treatment outcome, and will lead to much-needed research about the prevalence, symptomatology, neurobiology, and treatment of individuals with the dissociative subtype of PTSD. © 2012 Wiley Periodicals, Inc.

  3. The WRITTEN-HEART study (expressive writing for heart healing): rationale and design of a randomized controlled clinical trial of expressive writing in coronary patients referred to residential cardiac rehabilitation

    Science.gov (United States)

    2011-01-01

    Background Coronary heart disease (CHD) is typically associated with many cardiovascular risk factors (e.g., elevated blood pressure), low health-related quality of life, depression, anxiety and psychological stress. Expressive writing (EW) has shown beneficial effects on such variables in both people from the community and in patients with a variety of chronic illnesses. However, no study to date has evaluated the physical and psychological effects of the expressive writing procedure on coronary patients referred to cardiac rehabilitation (CR). Methods The clinical effectiveness of a 2-week disease-related expressive writing procedure (writing about one's deepest thoughts and feelings regarding the experience with heart disease) compared with the standard writing task (writing about one's deepest thoughts and feelings about the most traumatic or negative event experienced in the life), a neutral writing condition (writing about the facts regarding heart disease and its treatment) and an empty control condition will be evaluated in a randomized controlled clinical trial (RCT) with repeated follow-up measurements at 3, 6 and 12 months after discharge from CR. The primary outcome is health-related quality of life (SF-12). Secondary outcome measures are depression (BDI-II), anxiety (BAI) and post-traumatic growth (PTGI). Furthermore, the study will explore the moderating effects of coping styles, type D personality, perceived emotional support and participants' evaluative ratings of the writing interventions on the main experimental effects in order to identify sub-groups of patients showing different results. Discussion The WRITTEN-HEART study aims to explore and expand the frontiers of the expressive writing research enterprise by investigating the feasibility, safety and clinical efficacy of brief and cost-effective expressive writing interventions in patients with CHD referred to CR. Trial registration ClinicalTrials.gov NCT01253486 PMID:21740564

  4. Clinical Studies

    DEFF Research Database (Denmark)

    Pallesen, Ulla

    universities and practicing dentists restore millions of teeth throughout the World with composite resin materials. Do we know enough about the clinical performance of these restorations over time? Numerous in vitro studies are being published on resin materials and adhesion, some of them attempting to imitate...... in vivo conditions. But real life is different and in vitro studies cannot include all variables. Only clinical studies can provide valid information on the clinical performance of restorations over time. What do we know about longevity of posterior resin restorations? What are the reasons for replacement...... and results from own up to 30-year prospective clinical university studies and practice based studies from Public Dental Health Service on the clinical performance of posterior composite resin restorations....

  5. Rationale and Design of the Echocardiographic Study of Hispanics/Latinos (ECHO-SOL).

    Science.gov (United States)

    Rodriguez, Carlos J; Dharod, Ajay; Allison, Matthew A; Shah, Sanjiv J; Hurwitz, Barry; Bangdiwala, Shrikant I; Gonzalez, Franklyn; Kitzman, Dalane; Gillam, Linda; Spevack, Daniel; Dadhania, Rupal; Langdon, Sarah; Kaplan, Robert

    2015-01-01

    Information regarding the prevalence and determinants of cardiac structure and function (systolic and diastolic) among the various Hispanic background groups in the United States is limited. The Echocardiographic Study of Latinos (ECHO-SOL) ancillary study recruited 1,824 participants through a stratified-sampling process representative of the population-based Hispanic Communities Health Study - Study of Latinos (HCHS-SOL) across four sites (Bronx, NY; Chicago, Ill; San Diego, Calif; Miami, Fla). The HCHS-SOL baseline cohort did not include an echo exam. ECHO-SOL added the echocardiographic assessment of cardiac structure and function to an array of existing HCHS-SOL baseline clinical, psychosocial, and socioeconomic data and provides sufficient statistical power for comparisons among the Hispanic subgroups. Standard two-dimensional (2D) echocardiography protocol, including M-mode, spectral, color and tissue Doppler study was performed. The main objectives were to: 1) characterize cardiac structure and function and its determinants among Hispanics and Hispanic subgroups; and 2) determine the contributions of specific psychosocial factors (acculturation and familismo) to cardiac structure and function among Hispanics. We describe the design, methods and rationale of currently the largest and most comprehensive study of cardiac structure and function exclusively among US Hispanics. ECHO-SOL aims to enhance our understanding of Hispanic cardiovascular health as well as help untangle the relative importance of Hispanic subgroup heterogeneity and sociocultural factors on cardiac structure and function.

  6. The SPYRAL HTN Global Clinical Trial Program: Rationale and design for studies of renal denervation in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON-MED) of antihypertensive medications.

    Science.gov (United States)

    Kandzari, David E; Kario, Kazuomi; Mahfoud, Felix; Cohen, Sidney A; Pilcher, Garrett; Pocock, Stuart; Townsend, Raymond; Weber, Michael A; Böhm, Michael

    2016-01-01

    Renal sympathetic activation plays a key role in the pathogenesis of hypertension, as demonstrated by high renal norepinephrine spillover into plasma of patients with essential hypertension. Renal denervation has demonstrated a significant reduction in blood pressure in unblinded studies of hypertensive patients. The SYMPLICITY HTN-3 trial, the first prospective, masked, randomized study of renal denervation versus sham control, failed its primary efficacy end point and raised important questions around potentially confounding factors, such as drug changes and adherence, study population, and procedural methods. The SPYRAL HTN Global Clinical Trial Program is designed to address limitations associated with predicate studies and provide insight into the impact of pharmacotherapy on renal denervation efficacy. The 2 initial trials of the program focus on the effect of renal denervation using the Symplicity Spyral multielectrode renal denervation catheter in hypertensive patients in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON-MED) of antihypertensive medications. The SPYRAL HTN ON-MED study requires patients to be treated with a consistent triple therapy antihypertensive regimen, whereas the SPYRAL HTN OFF-MED study includes a 3- to 4-week drug washout period followed by a 3-month efficacy and safety end point in the absence of antihypertensive medications. The studies will randomize patients with combined systolic-diastolic hypertension to renal denervation or sham procedure. Both studies allow renal denervation treatments in renal artery branches and accessories. These studies will inform the design of the second pivotal phase of the program, which will more definitively analyze the antihypertensive effect of renal denervation. Copyright © 2015 Elsevier Inc. All rights reserved.

  7. Study Design and Rationale for the Phase 3 Clinical Development Program of Enobosarm, a Selective Androgen Receptor Modulator, for the Prevention and Treatment of Muscle Wasting in Cancer Patients (POWER Trials).

    Science.gov (United States)

    Crawford, Jeffrey; Prado, Carla M M; Johnston, Mary Ann; Gralla, Richard J; Taylor, Ryan P; Hancock, Michael L; Dalton, James T

    2016-06-01

    subject must have ≥10 % improvement in physical function compared to baseline. To meet the definition of response on LBM, a subject must have demonstrated no loss of LBM compared with baseline. Secondary endpoints include durability of response assessed at day 147 in those responding at day 84. A combined overall survival analysis for both studies is considered a key secondary safety endpoint. The POWER trials design was established with extensive clinical input and collaboration with regulatory agencies. The efficacy endpoints are a result of this feedback and discussion of the threshold for clinical benefit in patients at risk for muscle wasting. Full results from these studies will soon be published and will further guide the development of future anabolic trials. Clinical Trial ID: NCT01355484. https://clinicaltrials.gov/ct2/show/NCT01355484 , NCT01355497. https://clinicaltrials.gov/ct2/show/NCT01355497?term=g300505&rank=1 .

  8. Rationales Shaping International Linkages in Higher Education: A Qualitative Case Study of the ASU-ITESM Strategic Alliance

    Science.gov (United States)

    Camacho Lizarraga, Monica Irene

    2011-01-01

    This qualitative case study examines the rationales of the relationship between Arizona State University (ASU)--an American public research university--and Tecnologico de Monterrey (ITESM), a Mexican private not for profit research university. The focus of the study is to document the different meanings participants attached to the rationales of…

  9. The rationale for use of Ulipristal Acetate as first line in emergency contraception: biological and clinical evidence.

    Science.gov (United States)

    Glasier, Anna

    2014-10-01

    Ulipristal acetate (UPA) was licensed as an emergency contraceptive (EC) in Europe in 2009. By the end of May 2013, over 1.4 million courses had been used. The rationale for using UPA for EC in favor of the much more commonly used levonorgestrel (LNG) is based on data on efficacy, safety and side effects. In two large clinical trials among women presenting for EC up to 120 hours after unprotected sex, UPA was as effective as LNG at preventing pregnancy. When the two trials were combined in a meta analysis UPA was superior, almost halving the risk of pregnancy compared with LNG. Biomedical studies have shown that UPA inhibits or delays ovulation more effectively than LNG at a stage of the cycle when the risk of pregnancy is highest. Safety and side effects: UPA and LNG have similar side effect profiles and to date no serious adverse events have been attributed to use of UPA for EC. Data on pregnancies conceived in association with UPA use are reassuring. There is no evidence for teratogenesis or for any increased risk of ectopic pregnancy or miscarriage. Use of UPA will remain limited until it is available without a doctor's prescription.

  10. The effect of a family-based mindfulness intervention on children with attention deficit and hyperactivity symptoms and their parents: design and rationale for a randomized, controlled clinical trial (Study protocol).

    Science.gov (United States)

    Lo, Herman H M; Wong, Samuel Y S; Wong, Janet Y H; Wong, Simpson W L; Yeung, Jerf W K

    2016-03-15

    probably the first randomized controlled trial of FBMI for young children and their caregivers. A rigorous design and multiple outcome measures are used to examine the effectiveness of FBMI. If the hypotheses are confirmed, FBMI may serve as an additional treatment option for children with ADHD. This study is registered with the Chinese Clinical Trial Registry (reference number: ChiCTR-IOR-15007292 ). Registered 28 October 2015.

  11. Rationales, design and recruitment for the Elfe longitudinal study

    Directory of Open Access Journals (Sweden)

    Salines Georges

    2009-09-01

    Full Text Available Abstract Background Many factors act simultaneously in childhood to influence health status, life chances and well being, including pre-birth influences, the environmental pollutants of early life, health status but also the social influences of family and school. A cohort study is needed to disentangle these influences and explore attribution. Methods Elfe will be a nationally representative cohort of 20 000 children followed from birth to adulthood using a multidisciplinary approach. The cohort will be based on the INSEE Permanent Demographic Panel (EDP established using census data and civil records. The sample size has been defined in order to match the representativeness criteria and to obtain some prevalence estimation, but also to address the research area of low exposure/rare effects. The cohort will be based on repeated surveys by face to face or phone interview (at birth and each year as well as medical interview (at 2 years and examination (at 6 years. Furthermore, biological samples will be taken at birth to evaluate the foetal exposition to toxic substances, environmental sensors will be placed in the child's homes. Pilot studies have been initiated in 2007 (500 children with an overall acceptance rate of 55% and are currently under progress, the 2-year survey being carried out in October this year. Discussion The longitudinal study will provide a unique source of data to analyse the development of children in their environment, to study the various factors interacting throughout the life course up to adulthood and to determine the impact of childhood experience on the individual's physical, psychological, social and professional development.

  12. Apixaban for treatment of embolic stroke of undetermined source (ATTICUS randomized trial): Rationale and study design.

    Science.gov (United States)

    Geisler, Tobias; Poli, Sven; Meisner, Christoph; Schreieck, Juergen; Zuern, Christine S; Nägele, Thomas; Brachmann, Johannes; Jung, Werner; Gahn, Georg; Schmid, Elisabeth; Bäezner, Hansjörg; Keller, Timea; Petzold, Gabor C; Schrickel, Jan-Wilko; Liman, Jan; Wachter, Rolf; Schön, Frauke; Schabet, Martin; Lindner, Alfred; Ludolph, Albert C; Kimmig, Hubert; Jander, Sebastian; Schlegel, Uwe; Gawaz, Meinrad; Ziemann, Ulf

    2017-12-01

    Rationale Optimal secondary prevention of embolic stroke of undetermined source is not established. The current standard in these patients is acetylsalicylic acid, despite high prevalence of yet undetected paroxysmal atrial fibrillation. Aim The ATTICUS randomized trial is designed to determine whether the factor Xa inhibitor apixaban administered within 7 days after embolic stroke of undetermined source, is superior to acetylsalicylic acid for prevention of new ischemic lesions documented by brain magnetic resonance imaging within 12 months after index stroke. Design Prospective, randomized, blinded, parallel-group, open-label, German multicenter phase III trial in approximately 500 patients with embolic stroke of undetermined source. A key inclusion criterion is the presence or the planned implantation of an insertable cardiac monitor. Patients are 1:1 randomized to apixaban or acetylsalicylic acid and treated for a 12-month period. It is an event-driven trial aiming for core-lab adjudicated primary outcome events. Study outcomes The primary outcome is the occurrence of at least one new ischemic lesion identified by axial T2-weighted FLAIR magnetic resonance imaging and/or axial DWI magnetic resonance imaging at 12 months when compared with the baseline magnetic resonance imaging. Key secondary outcomes are the combination of recurrent ischemic strokes, hemorrhagic strokes, systemic embolism; combination of MACE including recurrent stroke, myocardial infarction, and cardiovascular death and combination of major and clinically relevant non-major bleeding defined according to ISTH, and change of cognitive function and quality of life (EQ-5D, Stroke Impact Scale). Discussion Embolic stroke of undetermined source is caused by embolic disease and associated with a high risk of recurrent ischemic strokes and clinically silent cerebral ischemic lesions. ATTICUS will investigate the impact of atrial fibrillation detected by insertable cardiac monitor and the effects of

  13. The Reversal Intervention for Metabolic Syndrome (TRIMS study: rationale, design, and baseline data

    Directory of Open Access Journals (Sweden)

    Troughton Jacqui

    2011-05-01

    Full Text Available Abstract Background Recent attention has focused on strategies to combat the forecast epidemic of type-2 diabetes (T2DM and its major vascular sequelae. Metabolic syndrome (MetS comprises a constellation of factors that increase the risk of cardiovascular disease (CVD and T2DM. Our study aims to develop a structured self-management education programme for people with MetS, which includes management of cardiovascular and diabetes risk factors, and to determine its impact. This paper describes the rationale and design of the TRIMS study, including intervention development, and presents baseline data. Methods Subjects recruited from a mixed-ethnic population with MetS were randomised to intervention or control arms. The intervention arm received structured group education based on robust psychological theories and current evidence. The control group received routine care. Follow-up data will be collected at 6 and 12 months. The primary outcome measure will be reversal of metabolic syndrome in the intervention group subjects compared to controls at 12 months follow-up. Results 82 participants (44% male, 22% South Asian were recruited between November 2009 and July 2010. Baseline characteristics were similar for both the intervention (n = 42 and control groups (n = 40. Median age was 63 years (IQR 57 - 67, mean waist size 106 cm (SD ± 11, and prescribing of statins and anti-hypertensives was 51% in each case. Conclusion Results will provide information on changes in diabetes and CVD risk factors and help to inform primary prevention strategies in people with MetS from varied ethnic backgrounds who are at high risk of developing T2DM and CVD. Information gathered in relation to the programme's acceptability and effectiveness in a multi-ethnic population would ensure that our results are widely applicable. Trial registration The study is registered at ClinicalTrials.gov, study identifier: NCT01043770.

  14. Automating Construction of Machine Learning Models With Clinical Big Data: Proposal Rationale and Methods.

    Science.gov (United States)

    Luo, Gang; Stone, Bryan L; Johnson, Michael D; Tarczy-Hornoch, Peter; Wilcox, Adam B; Mooney, Sean D; Sheng, Xiaoming; Haug, Peter J; Nkoy, Flory L

    2017-08-29

    To improve health outcomes and cut health care costs, we often need to conduct prediction/classification using large clinical datasets (aka, clinical big data), for example, to identify high-risk patients for preventive interventions. Machine learning has been proposed as a key technology for doing this. Machine learning has won most data science competitions and could support many clinical activities, yet only 15% of hospitals use it for even limited purposes. Despite familiarity with data, health care researchers often lack machine learning expertise to directly use clinical big data, creating a hurdle in realizing value from their data. Health care researchers can work with data scientists with deep machine learning knowledge, but it takes time and effort for both parties to communicate effectively. Facing a shortage in the United States of data scientists and hiring competition from companies with deep pockets, health care systems have difficulty recruiting data scientists. Building and generalizing a machine learning model often requires hundreds to thousands of manual iterations by data scientists to select the following: (1) hyper-parameter values and complex algorithms that greatly affect model accuracy and (2) operators and periods for temporally aggregating clinical attributes (eg, whether a patient's weight kept rising in the past year). This process becomes infeasible with limited budgets. This study's goal is to enable health care researchers to directly use clinical big data, make machine learning feasible with limited budgets and data scientist resources, and realize value from data. This study will allow us to achieve the following: (1) finish developing the new software, Automated Machine Learning (Auto-ML), to automate model selection for machine learning with clinical big data and validate Auto-ML on seven benchmark modeling problems of clinical importance; (2) apply Auto-ML and novel methodology to two new modeling problems crucial for care

  15. Rationale, Design, and Baseline Characteristics of ARTS-DN : A Randomized Study to Assess the Safety and Efficacy of Finerenone in Patients with Type 2 Diabetes Mellitus and a Clinical Diagnosis of Diabetic Nephropathy

    NARCIS (Netherlands)

    Ruilope, Luis M.; Agarwal, Rajiv; Chan, Juliana C.; Cooper, Mark E.; Gansevoort, Ron T.; Haller, Hermann; Remuzzi, Giuseppe; Rossing, Peter; Schmieder, Roland E.; Nowack, Christina; Ferreira, Anna C.; Pieper, Alexander; Kimmeskamp-Kirschbaum, Nina; Bakris, George L.

    2014-01-01

    Background/Aims: Finerenone decreases albuminuria in patients having heart failure with reduced ejection fraction and mild-to-moderate (stage 2-3) chronic kidney disease. The MinerAlocorticoid Receptor Antagonist Tolerability Study-Diabetic Nephropathy (ARTS-DN; NCT01874431) is a multicenter,

  16. Narrative reconstruction therapy for prolonged grief disorder—rationale and case study

    Directory of Open Access Journals (Sweden)

    Tuvia Peri

    2016-05-01

    Full Text Available Background: Prolonged grief disorder (PGD is a potentially disabling condition affecting approximately 10% of bereaved people. It has been suggested that the impaired integration of the loss memory, as expressed in recurrent memories of the loss and disorganization of memory, is involved in the development of PGD. Narrative reconstruction (NR, originally designed for the treatment of posttraumatic stress disorder (PTSD in an integrative therapy module, and consisting of exposure to the loss memory, detailed written reconstruction of the loss memory narrative and an elaboration of the personal significance of that memory for the bereaved, has been shown to be effective in the treatment of intrusion symptoms. Objective: In light of findings that cognitive behavior therapy (CBT, including cognitive restructuring and exposure, is effective in the treatment of PGD, we suggest the implementation of a somewhat novel therapy module, NR, for the treatment of intrusive phenomena in bereaved patients. Method: The rationale for the implementation of NR for PGD and a case study of the treatment of a woman suffering from PGD after the death of her father are presented. Therapy took place in a university outpatient training clinic. Results: Evaluations conducted before and after treatment and at a 3-month follow-up demonstrated the effectiveness of NR in reducing symptoms of PGD and depression. The analysis of spontaneous narratives recorded before and after treatment showed an increased organization of the narratives. Conclusions: This case report demonstrates an adaptation of NR for the treatment of PGD. The results provide preliminary support for the effectiveness of NR for PGD. The significance of the study and its limitations are discussed.

  17. A phase Ia/Ib clinical trial of metronomic chemotherapy based on a mathematical model of oral vinorelbine in metastatic non-small cell lung cancer and malignant pleural mesothelioma: rationale and study protocol

    International Nuclear Information System (INIS)

    Elharrar, Xavier; Barbolosi, Dominique; Ciccolini, Joseph; Meille, Christophe; Faivre, Christian; Lacarelle, Bruno; André, Nicolas; Barlesi, Fabrice

    2016-01-01

    Metronomic oral vinorelbine is effective in metastatic NSCLC and malignant pleural mesothelioma, but all the studies published thus far were based upon a variety of empirical and possibly suboptimal schedules, with inconsistent results. Mathematical modelling showed by simulation that a new metronomic protocol could lead to a better safety and efficacy profile. This phase Ia/Ib trial was designed to confirm safety (phase Ia) and evaluate efficacy (phase Ib) of a new metronomic oral vinorelbine schedule. Patients with metastatic NSCLC or malignant pleural mesothelioma in whom standard treatments failed and who exhibited ECOG performance status 0–2 and adequate organ function will be eligible. Our mathematical PK-PD model suggested an alternative weekly D1, D2 and D4 schedule (named Vinorelbine Theoretical Protocol) with a respective dose of 60, 30 and 60 mg. Trial recruitment will be two-staged, as 12 patients are planned to participate in phase Ia to confirm safety and consolidate the calibration of the model parameters. Depending on the phase Ia results and after a favourable decision from a consultative committee, the extension phase (phase Ib) will be an efficacy study including 20 patients who will receive the Optimal Vinorelbine Theoretical Protocol. The primary endpoint is the tolerance (assessed by CTC v4.0) for the phase Ia and the objective response according to RECIST 1.1 for phase Ib. An ancillary study on circulating angiogenesis biomarkers will be a subproject of the trial. This ongoing trial is the first to prospectively test a mathematically optimized schedule in metronomic chemotherapy. As such, this trial can be considered as a proof-of-concept study demonstrating the feasibility to run a computational-driven protocol to ensure an optimal efficacy/toxicity balance in patients with cancer

  18. Studying the effects of classic hallucinogens in the treatment of alcoholism: rationale, methodology, and current research with psilocybin.

    Science.gov (United States)

    Bogenschutz, Michael P

    2013-03-01

    Recent developments in the study of classic hallucinogens, combined with a re-appraisal of the older literature, have led to a renewal of interest in possible therapeutic applications for these drugs, notably their application in the treatment of addictions. This article will first provide a brief review of the research literature providing direct and indirect support for the possible therapeutic effects of classic hallucinogens such as psilocybin and lysergic acid diethylamide (LSD) in the treatment of addictions. Having provided a rationale for clinical investigation in this area, we discuss design issues in clinical trials using classic hallucinogens, some of which are unique to this class of drug. We then discuss the current status of this field of research and design considerations in future randomized trials.

  19. Design, rationale and feasibility of a multidimensional experimental protocol to study early life stress

    Directory of Open Access Journals (Sweden)

    M. Dillwyn Bartholomeusz

    2017-09-01

    Full Text Available There is a rapidly accumulating body of evidence regarding the influential role of early life stress (ELS upon medical and psychiatric conditions. While self-report instruments, with their intrinsic limitations of recall, remain the primary means of detecting ELS in humans, biological measures are generally limited to a single biological system. This paper describes the design, rationale and feasibility of a study to simultaneously measure neuroendocrine, immune and autonomic nervous system (ANS responses to psychological and physiological stressors in relation to ELS. Five healthy university students were recruited by advertisement. Exclusion criteria included chronic medical conditions, psychotic disorders, needle phobia, inability to tolerate pain, and those using anti-inflammatory medications. They were clinically interviewed and physiological recordings made over a two-hour period pre, during and post two acute stressors: the cold pressor test and recalling a distressing memory. The Childhood Trauma Questionnaire and the Parental Bonding Index were utilised to measure ELS. Other psychological measures of mood and personality were also administered. Measurements of heart rate, blood pressure, respiratory rate, skin conductance, skin blood flow and temporal plasma samples were successfully obtained before, during and after acute stress. Participants reported the extensive psychological and multisystem physiological data collection and stress provocations were tolerable. Most (4/5 participants indicated a willingness to return to repeat the protocol, indicating acceptability. Our protocol is viable and safe in young physically healthy adults and allows us to assess simultaneously neuroendocrine, immune and autonomic nervous system responses to stressors in persons assessed for ELS. Keywords: Childhood-stress, Adverse-childhood-events, Childhood-trauma questionnaire, Parental-bonding-instrument, Type D scale (DS14

  20. Child/Adolescent Anxiety Multimodal Study (CAMS: rationale, design, and methods

    Directory of Open Access Journals (Sweden)

    Waslick Bruce D

    2010-01-01

    Full Text Available Abstract Objective To present the design, methods, and rationale of the Child/Adolescent Anxiety Multimodal Study (CAMS, a recently completed federally-funded, multi-site, randomized placebo-controlled trial that examined the relative efficacy of cognitive-behavior therapy (CBT, sertraline (SRT, and their combination (COMB against pill placebo (PBO for the treatment of separation anxiety disorder (SAD, generalized anxiety disorder (GAD and social phobia (SoP in children and adolescents. Methods Following a brief review of the acute outcomes of the CAMS trial, as well as the psychosocial and pharmacologic treatment literature for pediatric anxiety disorders, the design and methods of the CAMS trial are described. Results CAMS was a six-year, six-site, randomized controlled trial. Four hundred eighty-eight (N = 488 children and adolescents (ages 7-17 years with DSM-IV-TR diagnoses of SAD, GAD, or SoP were randomly assigned to one of four treatment conditions: CBT, SRT, COMB, or PBO. Assessments of anxiety symptoms, safety, and functional outcomes, as well as putative mediators and moderators of treatment response were completed in a multi-measure, multi-informant fashion. Manual-based therapies, trained clinicians and independent evaluators were used to ensure treatment and assessment fidelity. A multi-layered administrative structure with representation from all sites facilitated cross-site coordination of the entire trial, study protocols and quality assurance. Conclusions CAMS offers a model for clinical trials methods applicable to psychosocial and psychopharmacological comparative treatment trials by using state-of-the-art methods and rigorous cross-site quality controls. CAMS also provided a large-scale examination of the relative and combined efficacy and safety of the best evidenced-based psychosocial (CBT and pharmacologic (SSRI treatments to date for the most commonly occurring pediatric anxiety disorders. Primary and secondary results

  1. The Mediterranean healthy eating, ageing, and lifestyle (MEAL) study: rationale and study design.

    Science.gov (United States)

    Grosso, Giuseppe; Marventano, Stefano; D'Urso, Maurizio; Mistretta, Antonio; Galvano, Fabio

    2017-08-01

    There is accumulating evidence suggesting that Mediterranean lifestyles, including nutrition and sleeping patterns as well as social integration, may play a role in reducing age-related diseases. However, the literature is mostly deficient of evidence provided by Italian Mediterranean islands that more closely adhered to the originally described lifestyles. In this paper, we described the rationale and the study design of the Mediterranean healthy Eating, Ageing, and Lifestyle (MEAL) study, a prospective population-based cohort established in Sicily, southern Italy. The main exposures investigated are classical determinants of health, including demographic, nutritional habits, smoking and physical activity status, as well as eating-related behaviors, sleeping habits, sun exposure, social resources, and perceived stress. Anthropometric measurements will be collected. The main outcomes included depression, quality of life, and, after the follow-up period, also cardiovascular disease and cancer. The MEAL study may provide important data to increase our knowledge regarding the prevalence, incidence, and risk factors of age-related disorders in the Mediterranean region.

  2. Clinical investigations of the therapeutic potential of ayahuasca: rationale and regulatory challenges.

    Science.gov (United States)

    McKenna, Dennis J

    2004-05-01

    Ayahuasca is a hallucinogenic beverage that is prominent in the ethnomedicine and shamanism of indigenous Amazonian tribes. Its unique pharmacology depends on the oral activity of the hallucinogen, N,N-dimethyltryptamine (DMT), which results from inhibition of monoamine oxidase (MAO) by beta-carboline alkaloids. MAO is the enzyme that normally degrades DMT in the liver and gut. Ayahuasca has long been integrated into mestizo folk medicine in the northwest Amazon. In Brazil, it is used as a sacrament by several syncretic churches. Some of these organizations have incorporated in the United States. The recreational and religious use of ayahuasca in the United States, as well as "ayahuasca tourism" in the Amazon, is increasing. The current legal status of ayahuasca or its source plants in the United States is unclear, although DMT is a Schedule I controlled substance. One ayahuasca church has received favorable rulings in 2 federal courts in response to its petition to the Department of Justice for the right to use ayahuasca under the Religious Freedom Restoration Act. A biomedical study of one of the churches, the Uñiao do Vegetal (UDV), indicated that ayahuasca may have therapeutic applications for the treatment of alcoholism, substance abuse, and possibly other disorders. Clinical studies conducted in Spain have demonstrated that ayahuasca can be used safely in normal healthy adults, but have done little to clarify its potential therapeutic uses. Because of ayahuasca's ill-defined legal status and variable botanical and chemical composition, clinical investigations in the United States, ideally under an approved Investigational New Drug (IND) protocol, are complicated by both regulatory and methodological issues. This article provides an overview of ayahuasca and discusses some of the challenges that must be overcome before it can be clinically investigated in the United States.

  3. Longitudinal Andhra Pradesh Eye Disease Study: rationale, study design and research methodology.

    Science.gov (United States)

    Khanna, Rohit C; Murthy, Gudlavalleti Vs; Marmamula, Srinivas; Mettla, Asha Latha; Giridhar, Pyda; Banerjee, Seema; Shekhar, Konegari; Chakrabarti, Subhabrata; Gilbert, Clare; Rao, Gullapalli N

    2016-03-01

    The rationale, objectives, study design and procedures for the longitudinal Andhra Pradesh Eye Disease Study are described. A longitudinal cohort study was carried out. Participants include surviving cohort from the rural component of Andhra Pradesh Eye Disease Study. During 1996-2000, Andhra Pradesh Eye Disease Survey was conducted in three rural (n = 7771) and one urban (n = 2522) areas (now called Andhra Pradesh Eye Disease Study 1). In 2009-2010, a feasibility exercise (Andhra Pradesh Eye Disease Study 2) for a longitudinal study (Andhra Pradesh Eye Disease Study 3) was undertaken in the rural clusters only, as urban clusters no longer existed. In Andhra Pradesh Eye Disease Study 3, a detailed interview will be carried out to collect data on sociodemographic factors, ocular and systemic history, risk factors, visual function, knowledge of eye diseases and barriers to accessing services. All participants will also undergo a comprehensive eye examination including photography of lens, optic disc and retina, Optic Coherence Tomography of the posterior segment, anthropometry, blood pressure and frailty measures. Measures include estimates of the incidence of visual impairment and age-related eye disease (lens opacities, glaucoma and age-related macular degeneration) and the progression of eye disease (lens opacities and myopia) and associated risk factors. Of the 7771 respondents examined in rural areas in Andhra Pradesh Eye Disease Study 1, 5447 (70.1%) participants were traced in Andhra Pradesh Eye Disease Study 2. These participants will be re-examined. Andhra Pradesh Eye Disease Study 3 will provide data on the incidence and progression of visual impairment and major eye diseases and their associated risk factors in India. The study will provide further evidence to aid planning eye care services. © 2015 Royal Australian and New Zealand College of Ophthalmologists.

  4. Evaluating web-based cognitive-affective remediation in recent trauma survivors: study rationale and protocol.

    Science.gov (United States)

    Fine, Naomi B; Achituv, Michal; Etkin, Amit; Merin, Ofer; Shalev, Arieh Y

    2018-01-01

    Background : The immediate aftermath of traumatic events is a period of enhanced neural plasticity, following which some survivors remain with post-traumatic stress disorder (PTSD) whereas others recover. Evidence points to impairments in emotional reactivity, emotion regulation, and broader executive functions as critically contributing to PTSD. Emerging evidence further suggests that the neural mechanisms underlying these functions remain plastic in adulthood and that targeted retraining of these systems may enhance their efficiency and could reduce the likelihood of developing PTSD. Administering targeted neurocognitive training shortly after trauma exposure is a daunting challenge. This work describes a study design addressing that challenge. The study evaluated the direct effects of cognitive remediation training on neurocognitive mechanisms that hypothetically underlay PTSD, and the indirect effect of this intervention on emerging PTSD symptoms. Method : We describe a study rationale, design, and methodological choices involving: (a) participants' enrolment; (b) implementation and management of a daily self-administered, web-based intervention; (c) reliable, timely screening and assessment of treatment of eligible survivors; and (d) defining control conditions and outcome measures. We outline the rationale of choices made regarding study sample, timing of intervention, measurements, monitoring participants' adherence, and ways to harmonize and retain interviewers' fidelity and mitigate eventual burnout by repeated contacts with recently traumatized survivors. Conclusion : Early web-based interventions targeting causative mechanisms of PTSD can be informed by the model presented in this paper.

  5. Danish pain specialists' rationales behind the choice of fentanyl transdermal patches and oral transmucosal systems-A Delphi study

    DEFF Research Database (Denmark)

    Jacobsen, Ramune; Møldrup, Claus; Christrup, Lona

    2009-01-01

    survey. Response rates were 45% in the brainstorming and 88% in the rating phases, respectively. Statistical analysis with SPSS for Windows 15.00 included descriptive statistics and factor analysis. Results. The most important rationale to choose fentanyl patches was that patients' clinical condition did...

  6. The Managed Ventricular pacing versus VVI 40 Pacing (MVP) Trial: clinical background, rationale, design, and implementation.

    Science.gov (United States)

    Sweeney, Michael O; Ellenbogen, Kenneth A; Miller, Elaine Hogan; Sherfesee, Lou; Sheldon, Todd; Whellan, David

    2006-12-01

    Implantable cardioverter defibrillators (ICDs) reduce mortality among appropriately selected patients who have had or are at risk for life-threatening ventricular arrhythmia. Right ventricular apical (RVA) pacing has been implicated in worsening heart failure and death. The optimal pacemaker mode for bradycardia support while minimizing unnecessary and potentially harmful RVA pacing has not been determined. The Managed Ventricular pacing vs. VVI 40 Pacing Trial (MVP) is a prospective, multicenter, randomized, single-blind, parallel, controlled clinical trial designed to establish whether atrial-based dual-chamber managed ventricular pacing mode (MVP) is equivalent or superior to back-up only ventricular pacing (VVI 40) among patients with standard indications for ICD therapy and no indication for bradycardia pacing. The MVP Trial is designed with 80% power to detect a 10% reduction in the primary endpoint of new or worsening heart failure or all-cause mortality in the MVP-treated group. Approximately 1,000 patients at 80 centers in the United States, Canada, Western Europe, and Israel will be randomized to MVP or VVI 40 pacing after successful implantation of a dual-chamber ICD. Heart failure therapies will be optimized in accordance with evidence-based guidelines. Prespecified secondary endpoints will include ventricular arrhythmias, atrial fibrillation, new indication for bradycardia pacing, health-related quality of life, and cost effectiveness. Enrollment began in October 2004 and concluded in April 2006. The study will be terminated upon recommendation of the Data Monitoring Committee or when the last patient enrolled and surviving has reached a minimum 2 years of follow-up. The MVP Trial will meet the clinical need for carefully designed prospective studies to define the benefits of atrial-based dual-chamber minimal ventricular pacing versus single-chamber ventricular pacing in conventional ICD patients.

  7. CORONARY DIET INTERVENTION WITH OLIVE OIL AND CARDIOVASCULAR PREVENTION STUDY (THE CORDIOPREV STUDY): RATIONALE, METHODS, AND BASELINE CHARACTERISTICS

    Science.gov (United States)

    Delgado-Lista, Javier; Perez-Martinez, Pablo; Garcia-Rios, Antonio; Alcala-Diaz, Juan F; Perez-Caballero, Ana I.; Gomez-Delgado, Francisco; Fuentes, Francisco; Quintana-Navarro, Gracia; Lopez-Segura, Fernando; Ortiz-Morales, Ana M; Delgado-Casado, Nieves; Yubero-Serrano, Elena; Camargo, Antonio; Marin, Carmen; Rodriguez-Cantalejo, Fernando; Gomez-Luna, Purificacion; Ordovas, Jose M; Lopez-Miranda, Jose; Perez-Jimenez, Francisco

    2016-01-01

    Coronary heart disease (CHD) represents a major global health burden. However, despite the well-known influence that dietary habits exert over the progression of this disease, there are no well-established and scientifically sound dietary approaches to prevent the onset of clinical outcomes in secondary prevention. The objective of the CORonary Diet Intervention with Olive oil and cardiovascular PREVention study (CORDIOPREV study, clinical trials number NCT00924937) is to compare the ability of a Mediterranean diet rich in virgin olive oil versus a low-fat diet to influence the composite incidence of cardiovascular events after 7 years, in subjects with documented CHD at baseline. For this purpose, we enrolled 1002 coronary patients from Spain. Baseline assessment (2009–12) included detailed interviews and measurements to assess dietary, social and biological variables. Results of baseline characteristics: The CORDIOPREV study in Spain describes a population with a high BMI (37.2% overweight and 56.3% obesity), with a median of LDL-cholesterol of 88.5 mg/dL (70.6% of the patients having <100 mg/dL, and 20.3% patients < 70 mg/dL). 9.6% of the participants were active smokers, and 64.4% were former smokers. Metabolic Syndrome was present in 58% of this population. To sum up, we describe here the rationale, methods and baseline characteristics of the CORDIOPREV study, which will test for the first time the efficacy of a Mediterranean Diet rich in extra virgin olive oil as compared with a low-fat diet on the incidence of CHD recurrence in a long term follow-up study. PMID:27297848

  8. Can lifestyle modification improve neurocognition? Rationale and design of the ENLIGHTEN clinical trial.

    Science.gov (United States)

    Blumenthal, James A; Smith, Patrick J; Welsh-Bohmer, Kathleen; Babyak, Michael A; Browndyke, Jeffrey; Lin, Pao-Hwa; Doraiswamy, P Murali; Burke, James; Kraus, William; Hinderliter, Alan; Sherwood, Andrew

    2013-01-01

    Risk factors for cardiovascular disease (CVD) not only increase the risk for clinical CVD events, but also are associated with a cascade of neurophysiologic and neuroanatomic changes that increase the risk of cognitive impairment and dementia. Although epidemiological studies have shown that exercise and diet are associated with lower CVD risk and reduced incidence of dementia, no randomized controlled trial (RCT) has examined the independent effects of exercise and diet on neurocognitive function among individuals at risk for dementia. The ENLIGHTEN trial is a RCT of patients with CVD risk factors who also are characterized by subjective cognitive complaints and objective evidence of neurocognitive impairment without dementia (CIND) STUDY DESIGN: A 2 by 2 design will examine the independent and combined effects of diet and exercise on neurocognition. 160 participants diagnosed with CIND will be randomly assigned to 6 months of aerobic exercise, the DASH diet, or a combination of both exercise and diet; a (control) group will receive health education but otherwise will maintain their usual dietary and activity habits. Participants will complete comprehensive assessments of neurocognitive functioning along with biomarkers of CVD risk including measures of blood pressure, glucose, endothelial function, and arterial stiffness. The ENLIGHTEN trial will (a) evaluate the effectiveness of aerobic exercise and the DASH diet in improving neurocognitive functioning in CIND patients with CVD risk factors; (b) examine possible mechanisms by which exercise and diet improve neurocognition; and (c) consider potential moderators of treatment, including subclinical CVD. Copyright © 2012 Elsevier Inc. All rights reserved.

  9. Clinical use of quantitative cardiac perfusion PET: rationale, modalities and possible indications. Position paper of the Cardiovascular Committee of the European Association of Nuclear Medicine (EANM)

    International Nuclear Information System (INIS)

    Sciagra, Roberto; Passeri, Alessandro; Bucerius, Jan; Verberne, Hein J.; Slart, Riemer H.J.A.; Lindner, Oliver; Gimelli, Alessia; Hyafil, Fabien; Agostini, Denis; Uebleis, Christopher; Hacker, Marcus

    2016-01-01

    Until recently, PET was regarded as a luxurious way of performing myocardial perfusion scintigraphy, with excellent image quality and diagnostic capabilities that hardly justified the additional cost and procedural effort. Quantitative perfusion PET was considered a major improvement over standard qualitative imaging, because it allows the measurement of parameters not otherwise available, but for many years its use was confined to academic and research settings. In recent years, however, several factors have contributed to the renewal of interest in quantitative perfusion PET, which has become a much more readily accessible technique due to progress in hardware and the availability of dedicated and user-friendly platforms and programs. In spite of this evolution and of the growing evidence that quantitative perfusion PET can play a role in the clinical setting, there are not yet clear indications for its clinical use. Therefore, the Cardiovascular Committee of the European Association of Nuclear Medicine, starting from the experience of its members, decided to examine the current literature on quantitative perfusion PET to (1) evaluate the rationale for its clinical use, (2) identify the main methodological requirements, (3) identify the remaining technical difficulties, (4) define the most reliable interpretation criteria, and finally (5) tentatively delineate currently acceptable and possibly appropriate clinical indications. The present position paper must be considered as a starting point aiming to promote a wider use of quantitative perfusion PET and to encourage the conception and execution of the studies needed to definitely establish its role in clinical practice. (orig.)

  10. Apixaban for the Secondary Prevention of Thrombosis Among Patients With Antiphospholipid Syndrome: Study Rationale and Design (ASTRO-APS).

    Science.gov (United States)

    Woller, Scott C; Stevens, Scott M; Kaplan, David A; Branch, D Ware; Aston, Valerie T; Wilson, Emily L; Gallo, Heather M; Johnson, Eric G; Rondina, Matthew T; Lloyd, James F; Evans, R Scott; Elliott, C Gregory

    2016-04-01

    Antiphospholipid syndrome (APS) is an acquired thrombophilia characterized by thrombosis, pregnancy morbidity, and the presence of characteristic antibodies. Current therapy for patients having APS with a history of thrombosis necessitates anticoagulation with the vitamin K antagonist warfarin, a challenging drug to manage. Apixaban, approved for the treatment and prevention of venous thrombosis with a low rate of bleeding observed, has never been studied among patients with APS. We report study rationale and design of Apixaban for the Secondary Prevention of Thrombosis Among Patients With Antiphospholipid Syndrome (ASTRO-APS), a prospective randomized open-label blinded event pilot study that will randomize patients with a clinical diagnosis of APS receiving therapeutic anticoagulation to either adjusted-dose warfarin or apixaban 2.5 mg twice a day. We aim to report our ability to identify, recruit, randomize, and retain patients with APS randomized to apixaban compared with warfarin. We will report clinically important outcomes of thrombosis and bleeding. All clinical outcomes will be adjudicated by a panel blinded to the treatment arm. A unique aspect of this study is the enrollment of patients with an established clinical diagnosis of APS. Also unique is our use of electronic medical record interrogation techniques to identify patients who would likely meet our inclusion criteria and use of an electronic portal for follow-up visit data capture. ASTRO-APS will be the largest prospective study to date comparing a direct oral anticoagulant with warfarin among patients with APS for the secondary prevention of thrombosis. Our inclusion criteria assure that outcomes obtained will be clinically applicable to the routine management of patients with APS receiving indefinite anticoagulation. © The Author(s) 2015.

  11. Infectious mononucleosis in children: clinical and laboratory rationale and economic efficiency of application of immunocorrectors

    Directory of Open Access Journals (Sweden)

    Shvedova N.M.

    2013-09-01

    Full Text Available Objective: to select the optimal, clinically and economacally effective immunocorrector for the treatment of immune-EBV — mononucleosis in children. Materials: 400 patients with primary Epstein — Barr virus infection aged 1 to 14 years. Results. The therapy by cycloferon of primary Epstein — Barr virus infection observed a statistically significant reduction in the length of stay of patients in hospital, on average, 3 bed-days. Inclusion of cycloferon, viferon in the treatment of infectious mononucleosis, reduces the severity and duration of symptoms of intoxication, the temperature reaction, hepatotoxicity, splenomegaly, lymphoproliferative syndrome. Against the background of cycloferon lower incidence of post-infection anemia was observed. Conclusion. The inclusion of immunocorrectors into therapeutic interventions in primary Epstein — Barr virus infection has been clinically and economically proved.

  12. Mesotherapy, definition, rationale and clinical role: a consensus report from the Italian Society of Mesotherapy.

    Science.gov (United States)

    Mammucari, M; Gatti, A; Maggiori, S; Bartoletti, C A; Sabato, A F

    2011-06-01

    Since its introduction in the 1950s, the use of mesotherapy has generated much interest among clinicians and patients. The Italian Society of Mesotherapy (SIM) brought together a panel of experts to review available evidence and to draw up a series of recommendations on the use of intradermal therapy (LIT) in clinical practice. There was overwhelming agreement among Consensus Group members that, when used correctly, LIT is a valuable therapeutic option in the treatment of painful, loco-regional conditions. They also emphasised that the clinical efficacy of LIT has been demonstrated in the management of chronic venous lymphatic insufficiency, oedematous fibrosclerotic panniculopathy and facial skin aging. The experts were unanimous on the use of LIT in vaccination. Mesotherapy is not a substitute for other therapeutic options and should only be used when the patient has been fully informed of its advantages and limitations. Likewise the procedure should only be carried out by an experienced qualified physician. Although there was widespread agreement among the Consensus Group on the place of LIT in several indications, the Authors reiterated the need for more large-scale clinical trials to determine the specific benefits and limitations in some areas of the application of intradermal therapy.

  13. Collaborative Behavioral Management for Drug-Involved Parolees: Rationale and Design of the Step'n Out Study

    Science.gov (United States)

    Friedmann, Peter D.; Katz, Elizabeth C.; Rhodes, Anne G.; Taxman, Faye S.; O'Connell, Daniel J.; Frisman, Linda K.; Burdon, William M.; Fletcher, Bennett W.; Litt, Mark D.; Clarke, Jennifer; Martin, Steven S.

    2008-01-01

    This article describes the rationale, study design, and implementation for the Step'n Out study of the Criminal Justice Drug Abuse Treatment Studies. Step'n Out tests the relative effectiveness of collaborative behavioral management of drug-involved parolees. Collaborative behavioral management integrates the roles of parole officers and treatment…

  14. A review and rationale for studying the cardiovascular effects of drinking water arsenic in women of reproductive age

    International Nuclear Information System (INIS)

    Kwok, Richard K.

    2007-01-01

    Drinking water arsenic has been shown to be associated with a host of adverse health outcomes at exposure levels > 300 μg of As/L. However, the results are not consistent at exposures below this level. We have reviewed selected articles that examine the effects of drinking water arsenic on cardiovascular outcomes and present a rationale for studying these effects on women of reproductive age, and also over the course of pregnancy when they would potentially be more susceptible to adverse cardiovascular and reproductive outcomes. It is only recently that reproductive effects have been linked to drinking water arsenic. However, there is a paucity of information about the cardiovascular effects of drinking water arsenic on women of reproductive age. Under the cardiovascular challenge of pregnancy, we hypothesize that women with a slightly elevated exposure to drinking water arsenic may exhibit adverse cardiovascular outcomes at higher rates than in the general population. Studying sensitive clinical and sub-clinical indicators of disease in susceptible sub-populations may yield important information about the potentially enormous burden of disease related to low-level drinking water arsenic exposure

  15. Rationale for nebivolol/valsartan combination for hypertension: review of preclinical and clinical data.

    Science.gov (United States)

    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.

  16. The design, rationale, and baseline characteristics of a nationwide cohort registry in China: blood pressure and clinical outcome in TIA or ischemic stroke.

    Science.gov (United States)

    Xu, Jie; Liu, Yi; Tao, Yongli; Xie, Xuewei; Gu, Hongqiu; Pan, Yuesong; Zhao, Xingquan; Wang, Yongjun; Yan, Aoshuang; Wang, Yilong

    2016-01-01

    The relationship between poststroke blood pressure (BP) and clinical outcomes in ischemic stroke (IS) is still controversial. However, there is no large BP database for IS or transient ischemic attack (TIA) in China. This study aims to describe the rationale, study design, and baseline characteristics of a nationwide BP database in IS or TIA patients in China. The BOSS (blood pressure and clinical outcome in TIA or ischemic stroke) study was a hospital-based, prospective cohort study aiming to assess BP parameters and clinical outcome in IS/TIA patients. BP parameters were based on office BP, ambulatory BP, and home BP. Clinical outcomes included stroke recurrence, combined vascular events, and disability. Electronic case-report forms were used to record baseline and follow-up data. The patients were followed up for clinical outcomes at 3 months through face-to-face interview and at 12 months by telephone. Between October 2012 and February 2014, the BOSS registry recruited 2,608 patients from 61 hospitals, with a mean age of 62.5 years, 32.4% of whom were female, 88.9% with an entry diagnosis of IS, and 86% diagnosed with hypertension. The rates of patients lost-to-follow-up were 3.1% at 3 months and 5.1% at 1 year; 93% of patients completed ambulatory BP monitoring during hospitalization and 94.7% finished a 3-month BP diary. The BOSS registry will provide important evidence about BP management in the acute phase and secondary prevention for IS/TIA patients.

  17. Significance of Haemodynamic and Haemostatic Factors in the Course of Different Manifestations of Cerebral Small Vessel Disease: The SHEF-CSVD Study—Study Rationale and Protocol

    Directory of Open Access Journals (Sweden)

    Jacek Staszewski

    2013-01-01

    Full Text Available Rationale. This paper describes the rationale and design of the SHEF-CSVD Study, which aims to determine the long-term clinical and radiological course of cerebral small vessel disease (CSVD and to evaluate haemostatic and haemodynamic prognostic factors of the condition. Design. This single-centre, prospective, non-interventional cohort study will follow 150 consecutive patients with different clinical manifestations of CSVD (lacunar ischaemic stroke, vascular dementia, vascular parkinsonism or spontaneous deep, intracerebral haemorrhage and 50 age- and sex-matched controls over a period of 24 months. The clinical and radiological course will be evaluated basing on a detailed neurological, neuropsychological and MRI examinations. Haemodynamic (cerebral vasoreactivity, 24 h blood pressure control and haemostatic factors (markers of endothelial and platelet dysfunction, brachial artery flow-mediated dilatation test will be determined. Discussion. The scheduled study will specifically address the issue of haemodynamic and haemostatic prognostic factors and their course over time in various clinical manifestations of CSVD. The findings may aid the development of prophylactic strategies and individualised treatment plans, which are critical during the early stages of the disease.

  18. The PROgnostic Value of unrequested Information in Diagnostic Imaging (PROVIDI) Study: rationale and design

    International Nuclear Information System (INIS)

    Gondrie, M. J. A.; Mali, W. P. Th. M.; Buckens, C. F. M.; Jacobs, P. C. A.; Grobbee, D. E.; Graaf, Y van der

    2010-01-01

    We describe the rationale for a new study examining the prognostic value of unrequested findings in diagnostic imaging. The deployment of more advanced imaging modalities in routine care means that such findings are being detected with increasing frequency. However, as the prognostic significance of many types of unrequested findings is unknown, the optimal response to such findings remains uncertain and in many cases an overly defensive approach is adopted, to the detriment of patient-care. Additionally, novel and promising image findings that are newly available on many routine scans cannot be used to improve patient care until their prognostic value is properly determined. The PROVIDI study seeks to address these issues using an innovative multi-center case-cohort study design. PROVIDI is to consist of a series of studies investigating specific, selected disease entities and clusters. Computed Tomography images from the participating hospitals are reviewed for unrequested findings. Subsequently, this data is pooled with outcome data from a central population registry. Study populations consist of patients with endpoints relevant to the (group of) disease(s) under study along with a random control sample from the cohort. This innovative design allows PROVIDI to evaluate selected unrequested image findings for their true prognostic value in a series of manageable studies. By incorporating unrequested image findings and outcomes data relevant to patients, truly meaningful conclusions about the prognostic value of unrequested and emerging image findings can be reached and used to improve patient-care.

  19. Rationale and Design of the Women and Inclusion in Academic Medicine Study.

    Science.gov (United States)

    Hill, Emorcia V; Wake, Michael; Carapinha, René; Normand, Sharon-Lise; Wolf, Robert E; Norris, Keith; Reede, Joan Y

    2016-04-21

    Women of color (WOC) (African American, Hispanic, Native American/Alaskan Native, and Asian American) faculty remain disproportionately underrepresented among medical school faculty and especially at senior ranks compared with White female faculty. The barriers or facilitators to the career advancement of WOC are poorly understood. The Women and Inclusion in Academic Medicine (WIAM) study was developed to characterize individual, institutional and sociocultural factors that influence the entry, progression and persistence, and advancement of women faculty in academic medical careers with a focus on WOC. Using a purposive sample of 13 academic medical institutions, we collected qualitative interview data from 21 WOC junior faculty and quantitative data from 3,127 (38.9% of 8,053 eligible women) respondents via an online survey. To gather institutional data, we used an online survey and conducted 23 key administrative informant interviews from the 13 institutions. Grounded theory methodology will be used to analyze qualitative data. Multivariable analysis including hierarchical linear modeling will be used to investigate outcomes, such as the inclusiveness of organizational gender climate and women faculty's intent to stay. We describe the design, methods, rationale and limitations of one of the largest and most comprehensive studies of women faculty in academic medicine with a focus on WOC. This study will enhance our understanding of challenges that face women, and, especially WOC, faculty in academic medicine and will provide solutions at both the individual and institutional levels.

  20. A Multi-site, Two-Phase, Prescription Opioid Addiction Treatment Study (POATS): Rationale, Design, and Methodology

    Science.gov (United States)

    Weiss, Roger D.; Potter, Jennifer Sharpe; Provost, Scott E.; Huang, Zhen; Jacobs, Petra; Hasson, Albert; Lindblad, Robert; Connery, Hilary Smith; Prather, Kristi; Ling, Walter

    2010-01-01

    The National Institute on Drug Abuse Clinical Trials Network launched the Prescription Opioid Addiction Treatment Study (POATS) in response to rising rates of prescription opioid dependence and gaps in understanding the optimal course of treatment for this population. POATS employed a multi-site, two-phase adaptive, sequential treatment design to approximate clinical practice. The study took place at 10 community treatment programs around the United States. Participants included men and women age ≥18 who met Diagnostic and Statistical Manual, 4th Edition criteria for dependence upon prescription opioids, with physiologic features; those with a prominent history of heroin use (according to pre-specified criteria) were excluded. All participants received buprenorphine/naloxone (bup/nx). Phase 1 consisted of 4 weeks of bup/nx treatment, including a 14-day dose taper, with 8 weeks of follow-up. Phase 1 participants were monitored for treatment response during these 12 weeks. Those who relapsed to opioid use, as defined by pre-specified criteria, were invited to enter Phase 2; Phase 2 consisted of 12 weeks of bup/nx stabilization treatment, followed by a 4-week taper and 8 weeks of post-treatment follow-up. Participants were randomized at the beginning of Phase 1 to receive bup/nx, paired with either Standard Medical Management (SMM) or Enhanced Medical Management (EMM; defined as SMM plus individual drug counseling). Eligible participants entering Phase 2 were re-randomized to either EMM or SMM. POATS was developed to determine what benefit, if any, EMM offers over SMM in short-term and longer-term treatment paradigm. This paper describes the rationale and design of the study. PMID:20116457

  1. The Pediatric Obsessive-Compulsive Disorder Treatment Study II: rationale, design and methods

    Directory of Open Access Journals (Sweden)

    March John S

    2009-01-01

    Full Text Available Abstract This paper presents the rationale, design, and methods of the Pediatric Obsessive-Compulsive Disorder Treatment Study II (POTS II, which investigates two different cognitive-behavior therapy (CBT augmentation approaches in children and adolescents who have experienced a partial response to pharmacotherapy with a serotonin reuptake inhibitor for OCD. The two CBT approaches test a "single doctor" versus "dual doctor" model of service delivery. A specific goal was to develop and test an easily disseminated protocol whereby child psychiatrists would provide instructions in core CBT procedures recommended for pediatric OCD (e.g., hierarchy development, in vivo exposure homework during routine medical management of OCD (I-CBT. The conventional "dual doctor" CBT protocol consists of 14 visits over 12 weeks involving: (1 psychoeducation, (2, cognitive training, (3 mapping OCD, and (4 exposure with response prevention (EX/RP. I-CBT is a 7-session version of CBT that does not include imaginal exposure or therapist-assisted EX/RP. In this study, we compared 12 weeks of medication management (MM provided by a study psychiatrist (MM only with two types of CBT augmentation: (1 the dual doctor model (MM+CBT; and (2 the single doctor model (MM+I-CBT. The design balanced elements of an efficacy study (e.g., random assignment, independent ratings with effectiveness research aims (e.g., differences in specific SRI medications, dosages, treatment providers. The study is wrapping up recruitment of 140 youth ages 7–17 with a primary diagnosis of OCD. Independent evaluators (IEs rated participants at weeks 0,4,8, and 12 during acute treatment and at 3,6, and 12 month follow-up visits. Trial registration NCT00074815

  2. The Shozu Herpes Zoster (SHEZ) Study: Rationale, Design, and Description of a Prospective Cohort Study

    Science.gov (United States)

    Takao, Yukiko; Miyazaki, Yoshiyuki; Onishi, Fumitake; Kumihashi, Hideaki; Gomi, Yasuyuki; Ishikawa, Toyokazu; Okuno, Yoshinobu; Mori, Yasuko; Asada, Hideo; Yamanishi, Koichi; Iso, Hiroyasu

    2012-01-01

    Background The incidence and risk factors for herpes zoster have been studied in cross-sectional and cohort studies, although most such studies have been conducted in Western countries. Evidence from Asian populations is limited, and no cohort study has been conducted in Asia. We are conducting a 3-year prospective cohort study in Shozu County in Kagawa Prefecture, Japan to determine the incidence and predictive and immunologic factors for herpes zoster among Japanese. Methods The participants are followed for 3 years, and a telephone survey is conducted every 4 weeks. The participants were assigned to 1 of 3 studies. Participants in study A gave information on past history of herpes zoster and completed health questionnaires. Study B participants additionally underwent varicella-zoster virus (VZV) skin testing, and study C participants additionally underwent blood testing. If the participants develop herpes zoster, we evaluate clinical symptoms, measure cell-mediated immunity and humoral immunity using venous blood sampling, photograph skin areas with rash, conduct virus identification testing by polymerase chain reaction (PCR) and virus isolation from crust sampling, and evaluate postherpetic pain. Results We recruited 12 522 participants aged 50 years or older in Shozu County from December 2009 through November 2010. The participation rate was 65.7% of the target population. Conclusions The present study is likely to provide valuable data on the incidence and predictive and immunologic factors for herpes zoster in a defined community-based population of Japanese. PMID:22343323

  3. The Action to Control Cardiovascular Risk in Diabetes Memory in Diabetes Study (ACCORD-MIND): rationale, design, and methods.

    Science.gov (United States)

    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.

  4. The NordiNet® International Outcome Study and NovoNet® ANSWER Program®: rationale, design, and methodology of two international pharmacoepidemiological registry-based studies monitoring long-term clinical and safety outcomes of growth hormone therapy (Norditropin®).

    Science.gov (United States)

    Höybye, Charlotte; Sävendahl, Lars; Christesen, Henrik Thybo; Lee, Peter; Pedersen, Birgitte Tønnes; Schlumpf, Michael; Germak, John; Ross, Judith

    2013-01-01

    Randomized controlled trials have shown that growth hormone (GH) therapy has effects on growth, metabolism, and body composition. GH therapy is prescribed for children with growth failure and adults with GH deficiency. Carefully conducted observational study of GH treatment affords the opportunity to assess long-term treatment outcomes and the clinical factors and variables affecting those outcomes, in patients receiving GH therapy in routine clinical practice. The NordiNet® International Outcome Study (IOS) and the American Norditropin® Web Enabled Research (ANSWER Program®) are two complementary, non-interventional, observational studies that adhere to current guidelines for pharmacoepidemiological data. The studies include pediatric and adult patients receiving Norditropin®, as prescribed by their physicians. The studies gather long-term data on the safety and effectiveness of reallife treatment with the recombinant human GH, Norditropin®. We describe the origins, aims, objectives, and design methodology of the studies, as well as their governance and validity, strengths, and limitations. The NordiNet® IOS and ANSWER Program® studies will provide valid insights into the effectiveness and safety of GH treatment across a diverse and large patient population treated in accordance with real-world clinical practice and following the Good Pharmacoepidemiological Practice and STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) guidelines.

  5. Campath, calcineurin inhibitor reduction and chronic allograft nephropathy (3C) study: background, rationale, and study protocol

    Science.gov (United States)

    2013-01-01

    Background Kidney transplantation is the best treatment for patients with end-stage renal failure, but uncertainty remains about the best immunosuppression strategy. Long-term graft survival has not improved substantially, and one possible explanation is calcineurin inhibitor (CNI) nephrotoxicity. CNI exposure could be minimized by using more potent induction therapy or alternative maintenance therapy to remove CNIs completely. However, the safety and efficacy of such strategies are unknown. Methods/Design The Campath, Calcineurin inhibitor reduction and Chronic allograft nephropathy (3C) Study is a multicentre, open-label, randomized controlled trial with 852 participants which is addressing two important questions in kidney transplantation. The first question is whether a Campath (alemtuzumab)-based induction therapy strategy is superior to basiliximab-based therapy, and the second is whether, from 6 months after transplantation, a sirolimus-based maintenance therapy strategy is superior to tacrolimus-based therapy. Recruitment is complete, and follow-up will continue for around 5 years post-transplant. The primary endpoint for the induction therapy comparison is biopsy-proven acute rejection by 6 months, and the primary endpoint for the maintenance therapy comparison is change in estimated glomerular filtration rate from baseline to 2 years after transplantation. The study is sponsored by the University of Oxford and endorsed by the British Transplantation Society, and 18 centers for adult kidney transplant are participating. Discussion Late graft failure is a major issue for kidney-transplant recipients. If our hypothesis that minimizing CNI exposure with Campath-based induction therapy and/or an elective conversion to sirolimus-based maintenance therapy can improve long-term graft function and survival is correct, then patients should experience better graft function for longer. A positive outcome could change clinical practice in kidney transplantation. Trial

  6. Predicting asthma in preschool children with asthma symptoms: study rationale and design

    Directory of Open Access Journals (Sweden)

    Hafkamp-de Groen Esther

    2012-10-01

    Full Text Available Abstract Background In well-child care it is difficult to determine whether preschool children with asthma symptoms actually have or will develop asthma at school age. The PIAMA (Prevention and Incidence of Asthma and Mite Allergy Risk Score has been proposed as an instrument that predicts asthma at school age, using eight easy obtainable parameters, assessed at the time of first asthma symptoms at preschool age. The aim of this study is to present the rationale and design of a study 1 to externally validate and update the PIAMA Risk Score, 2 to develop an Asthma Risk Appraisal Tool to predict asthma at school age in (specific subgroups of preschool children with asthma symptoms and 3 to test implementation of the Asthma Risk Appraisal Tool in well-child care. Methods and design The study will be performed within the framework of Generation R, a prospective multi-ethnic cohort study. In total, consent for postnatal follow-up was obtained from 7893 children, born between 2002 and 2006. At preschool age the PIAMA Risk Score will be assessed and used to predict asthma at school age. Discrimination (C-index and calibration will be assessed for the external validation. We will study whether the predictive ability of the PIAMA Risk Score can be improved by removing or adding predictors (e.g. preterm birth. The (updated PIAMA Risk Score will be converted to the Asthma Risk Appraisal Tool- to predict asthma at school age in preschool children with asthma symptoms. Additionally, we will conduct a pilot study to test implementation of the Asthma Risk Appraisal Tool in well-child care. Discussion Application of the Asthma Risk Appraisal Tool in well-child care will help to distinguish preschool children at high- and low-risk of developing asthma at school age when asthma symptoms appear. This study will increase knowledge about the validity of the PIAMA risk score and might improve risk assessment of developing asthma at school age in (specific subgroups

  7. Rationale and clinical utility of the darunavir–cobicistat combination in the treatment of HIV/AIDS

    Directory of Open Access Journals (Sweden)

    Putcharoen O

    2015-10-01

    Full Text Available Opass Putcharoen,1 Tanya Do,2 Anchalee Avihingsanon,2 Kiat Ruxrungtham1,2 1Department of Medicine, Faculty of Medicine, Chulalongkorn University, 2The HIV Netherlands Australia Thailand (HIV-NAT Research Collaboration, The Thai Red Cross AIDS Research Center, Bangkok, Thailand Abstract: This article is to provide an update overview of cobicistat (COBI-boosted darunavir in response to its recent approval by the US Food and Drug Administration, and inclusion as an alternative first-line regime in the 2015 treatment guidelines in the US. COBI is a relatively new non-antiretroviral cytochrome P450 3A inhibitor or pharmacoenhancer. The rationale behind COBI development was to provide an alternative to ritonavir (RTV as a protease inhibitor pharmacoenhancer, due to associated adverse events with short- and long-term RTV use, such as gastrointestinal intolerability, drug–drug interactions, insulin resistance, lipodystrophy, and hyperlipidemia. Although in vitro studies suggest that COBI may result in a lower incidence of undesired drug–drug interactions and lipid-associated disorders than RTV, not all Phase III studies have well addressed these issues, and the data are limited. However, Phase III studies have demonstrated tolerability, noninferiority, and bioequivalence of COBI compared to RTV. Two main advantages of COBI over RTV-containing regimes have been noted as follows: 1 COBI has no anti-HIV activity; therefore, resistance to COBI as a booster in addition to protease inhibitor resistance is of little concern, allowing for COBI-containing regimes in future. 2 COBI’s solubility and dissolution rate allow for co-formulated/fixed-dose combination products. Nonetheless, prior to initiating COBI-containing treatment regimens, the following should be considered: 1 COBI may increase serum creatinine levels and reduce estimated glomerular filtration rate (GFR without affecting actual GFR; 2 potential drug–drug interaction data are insufficient

  8. Improving metabolic parameters of antipsychotic child treatment (IMPACT) study: rationale, design, and methods

    OpenAIRE

    Reeves, Gloria M; Keeton, Courtney; Correll, Christoph U; Johnson, Jacqueline L; Hamer, Robert M; Sikich, Linmarie; Hazzard, Lindsey; Alderman, Cheryl; Scheer, Abigail; Mabe, Micah; Kapoor, Sandeep; Sheridan, Eva; Borner, Irmgard; Bussell, Kristin; Pirmohamed, Sara

    2013-01-01

    Background Youth with serious mental illness may experience improved psychiatric stability with second generation antipsychotic (SGA) medication treatment, but unfortunately may also experience unhealthy weight gain adverse events. Research on weight loss strategies for youth who require ongoing antipsychotic treatment is quite limited. The purpose of this paper is to present the design, methods, and rationale of the Improving Metabolic Parameters in Antipsychotic Child Treatment (IMPACT) stu...

  9. The Strathclyde Evaluation of Children's Active Travel (SE-CAT: study rationale and methods

    Directory of Open Access Journals (Sweden)

    McMinn David

    2011-12-01

    Full Text Available Abstract Background The school commute is a prime opportunity to increase children's physical activity levels. However, active commuting has decreased over the past 40 years. Strategies that increase walking to school are therefore needed. Travelling Green (TG is a school-based active travel resource aimed at increasing children's walking to school. The resource consists of a curriculum-based program of lessons and goal setting activities. A previous study found that children who received the TG intervention increased self-reported distance travelled to school by active modes and reduced the distance travelled by inactive modes. This study was limited by self-reported outcome measures, a small sample, and no follow-up measures. A more robust evaluation of TG is required to address these limitations. This paper describes the rationale and methods for such an evaluation of Travelling Green, and describes the piloting of various active commuting measures in primary school children. Methods/Design Measures of active commuting were piloted in a sample of 26 children (aged 8-9 years over one school week. These measures were subsequently used in an 18-month quasi-experimental design to evaluate the effect of TG on commuting behaviour. Participants were 166 children (60% male aged 8-9 years from 5 primary schools. Two schools (n = 79 children received TG in September/October 2009. Three schools (n = 87 children acted as a comparison group, and subsequently received TG at a later date. Physical activity was measured using Actigraph GT1M accelerometers. Personal and environmental determinants of active commuting were measured via parent and child questionnaires, as were factors related to the Theory of Planned Behaviour and the construct of habit. Measures were taken pre- and post-intervention and at 5 and 12 months follow-up. Discussion The piloted protocol was practical and feasible and piloted measures were reliable and valid. All study data, including

  10. Considerations in the rationale, design and methods of the Strategic Timing of AntiRetroviral Treatment (START) study

    Science.gov (United States)

    Babiker, Abdel G; Emery, Sean; Fätkenheuer, Gerd; Gordin, Fred M; Grund, Birgit; Lundgren, Jens D; Neaton, James D; Pett, Sarah L; Phillips, Andrew; Touloumi, Giota; Vjecha, Michael J

    2012-01-01

    Background Untreated human immunodeficiency virus (HIV) infection is characterized by progressive depletion of CD4+ T lymphocyte (CD4) count leading to the development of opportunistic diseases (acquired immunodeficiency syndrome (AIDS)), and more recent data suggest that HIV is also associated with an increased risk of serious non-AIDS (SNA) diseases including cardiovascular, renal, and liver diseases and non-AIDS-defining cancers. Although combination antiretroviral treatment (ART) has resulted in a substantial decrease in morbidity and mortality in persons with HIV infection, viral eradication is not feasible with currently available drugs. The optimal time to start ART for asymptomatic HIV infection is controversial and remains one of the key unanswered questions in the clinical management of HIV-infected individuals. Purpose In this article, we outline the rationale and methods of the Strategic Timing of AntiRetroviral Treatment (START) study, an ongoing multicenter international trial designed to assess the risks and benefits of initiating ART earlier than is currently practiced. We also describe some of the challenges encountered in the design and implementation of the study and how these challenges were addressed. Methods A total of 4000 study participants who are HIV type 1 (HIV-1) infected, ART naïve with CD4 count > 500 cells/μL are to be randomly allocated in a 1:1 ratio to start ART immediately (early ART) or defer treatment until CD4 count is AIDS, SNA, or death. The study had a pilot phase to establish feasibility of accrual, which was set as the enrollment of at least 900 participants in the first year. Results Challenges encountered in the design and implementation of the study included the limited amount of data on the risk of a major component of the primary endpoint (SNA) in the study population, changes in treatment guidelines when the pilot phase was well underway, and the complexities of conducting the trial in a geographically wide

  11. Texas Medication Algorithm Project, phase 3 (TMAP-3): rationale and study design.

    Science.gov (United States)

    Rush, A John; Crismon, M Lynn; Kashner, T Michael; Toprac, Marcia G; Carmody, Thomas J; Trivedi, Madhukar H; Suppes, Trisha; Miller, Alexander L; Biggs, Melanie M; Shores-Wilson, Kathy; Witte, Bradley P; Shon, Steven P; Rago, William V; Altshuler, Kenneth Z

    2003-04-01

    Medication treatment algorithms may improve clinical outcomes, uniformity of treatment, quality of care, and efficiency. However, such benefits have never been evaluated for patients with severe, persistent mental illnesses. This study compared clinical and economic outcomes of an algorithm-driven disease management program (ALGO) with treatment-as-usual (TAU) for adults with DSM-IV schizophrenia (SCZ), bipolar disorder (BD), and major depressive disorder (MDD) treated in public mental health outpatient clinics in Texas. The disorder-specific intervention ALGO included a consensually derived and feasibility-tested medication algorithm, a patient/family educational program, ongoing physician training and consultation, a uniform medical documentation system with routine assessment of symptoms and side effects at each clinic visit to guide ALGO implementation, and prompting by on-site clinical coordinators. A total of 19 clinics from 7 local authorities were matched by authority and urban status, such that 4 clinics each offered ALGO for only 1 disorder (SCZ, BD, or MDD). The remaining 7 TAU clinics offered no ALGO and thus served as controls (TAUnonALGO). To determine if ALGO for one disorder impacted care for another disorder within the same clinic ("culture effect"), additional TAU subjects were selected from 4 of the ALGO clinics offering ALGO for another disorder (TAUinALGO). Patient entry occurred over 13 months, beginning March 1998 and concluding with the final active patient visit in April 2000. Research outcomes assessed at baseline and periodically for at least 1 year included (1) symptoms, (2) functioning, (3) cognitive functioning (for SCZ), (4) medication side effects, (5) patient satisfaction, (6) physician satisfaction, (7) quality of life, (8) frequency of contacts with criminal justice and state welfare system, (9) mental health and medical service utilization and cost, and (10) alcohol and substance abuse and supplemental substance use information

  12. Rationale, design and objectives of ARegPKD, a European ARPKD registry study.

    Science.gov (United States)

    Ebner, Kathrin; Feldkoetter, Markus; Ariceta, Gema; Bergmann, Carsten; Buettner, Reinhard; Doyon, Anke; Duzova, Ali; Goebel, Heike; Haffner, Dieter; Hero, Barbara; Hoppe, Bernd; Illig, Thomas; Jankauskiene, Augustina; Klopp, Norman; König, Jens; Litwin, Mieczyslaw; Mekahli, Djalila; Ranchin, Bruno; Sander, Anja; Testa, Sara; Weber, Lutz Thorsten; Wicher, Dorota; Yuzbasioglu, Ayse; Zerres, Klaus; Dötsch, Jörg; Schaefer, Franz; Liebau, Max Christoph

    2015-02-18

    Autosomal recessive polycystic kidney disease (ARPKD) is a rare but frequently severe disorder that is typically characterized by cystic kidneys and congenital hepatic fibrosis but displays pronounced phenotypic heterogeneity. ARPKD is among the most important causes for pediatric end stage renal disease and a leading reason for liver-, kidney- or combined liver kidney transplantation in childhood. The underlying pathophysiology, the mechanisms resulting in the observed clinical heterogeneity and the long-term clinical evolution of patients remain poorly understood. Current treatment approaches continue to be largely symptomatic and opinion-based even in most-advanced medical centers. While large clinical trials for the frequent and mostly adult onset autosomal dominant polycystic kidney diseases have recently been conducted, therapeutic initiatives for ARPKD are facing the challenge of small and clinically variable cohorts for which reliable end points are hard to establish. ARegPKD is an international, mostly European, observational study to deeply phenotype ARPKD patients in a pro- and retrospective fashion. This registry study is conducted with the support of the German Society for Pediatric Nephrology (GPN) and the European Study Consortium for Chronic Kidney Disorders Affecting Pediatric Patients (ESCAPE Network). ARegPKD clinically characterizes long-term ARPKD courses by a web-based approach that uses detailed basic data questionnaires in combination with yearly follow-up visits. Clinical data collection is accompanied by associated biobanking and reference histology, thus setting roots for future translational research. The novel registry study ARegPKD aims to characterize miscellaneous subcohorts and to compare the applied treatment options in a large cohort of deeply characterized patients. ARegPKD will thus provide evidence base for clinical treatment decisions and contribute to the pathophysiological understanding of this severe inherited disorder.

  13. The population-based Barcelona-Asymptomatic Intracranial Atherosclerosis Study (ASIA: rationale and design

    Directory of Open Access Journals (Sweden)

    Pera Guillem

    2011-02-01

    Full Text Available Abstract Background Large-artery intracranial atherosclerosis may be the most frequent cause of ischemic stroke worldwide. Traditional approaches have attempted to target the disease when it is already symptomatic. However, early detection of intracranial atherosclerosis may allow therapeutic intervention while the disease is still asymptomatic. The prevalence and natural history of asymptomatic intracranial atherosclerosis in Caucasians remain unclear. The aims of the Barcelona-ASymptomatic Intracranial Atherosclerosis (ASIA study are (1 to determine the prevalence of ASIA in a moderate-high vascular risk population, (2 to study its prognostic impact on the risk of suffering future major ischemic events, and (3 to identify predictors of the development, progression and clinical expression of this condition. Methods/Design Cross-over and cohort, population-based study. A randomly selected representative sample of 1,503 subjects with a mild-moderate-high vascular risk (as defined by a REGICOR score ≥ 5% and with neither a history of cerebrovascular nor ischemic heart disease will be studied. At baseline, all individuals will undergo extracranial and transcranial Color-Coded Duplex (TCCD ultrasound examinations to detect presence and severity of extra and intracranial atherosclerosis. Intracranial stenoses will be assessed by magnetic resonance angiography (MRA. Clinical and demographic variables will be recorded and blood samples will be drawn to investigate clinical, biological and genetic factors associated with the presence of ASIA. A long-term clinical and sonographic follow-up will be conducted thereafter to identify predictors of disease progression and of incident vascular events. Discussion The Barcelona-ASIA is a population-based study aiming to evaluate the prevalence and clinical importance of asymptomatic intracranial large-artery atherosclerosis in Caucasians. The ASIA project may provide a unique scientific resource to better

  14. The population-based Barcelona-Asymptomatic Intracranial Atherosclerosis Study (ASIA): rationale and design.

    Science.gov (United States)

    López-Cancio, Elena; Dorado, Laura; Millán, Mónica; Reverté, Silvia; Suñol, Anna; Massuet, Anna; Mataró, María; Galán, Amparo; Alzamora, Maite; Pera, Guillem; Torán, Pere; Dávalos, Antoni; Arenillas, Juan F

    2011-02-17

    Large-artery intracranial atherosclerosis may be the most frequent cause of ischemic stroke worldwide. Traditional approaches have attempted to target the disease when it is already symptomatic. However, early detection of intracranial atherosclerosis may allow therapeutic intervention while the disease is still asymptomatic. The prevalence and natural history of asymptomatic intracranial atherosclerosis in Caucasians remain unclear. The aims of the Barcelona-ASymptomatic Intracranial Atherosclerosis (ASIA) study are (1) to determine the prevalence of ASIA in a moderate-high vascular risk population, (2) to study its prognostic impact on the risk of suffering future major ischemic events, and (3) to identify predictors of the development, progression and clinical expression of this condition. Cross-over and cohort, population-based study. A randomly selected representative sample of 1,503 subjects with a mild-moderate-high vascular risk (as defined by a REGICOR score ≥ 5%) and with neither a history of cerebrovascular nor ischemic heart disease will be studied. At baseline, all individuals will undergo extracranial and transcranial Color-Coded Duplex (TCCD) ultrasound examinations to detect presence and severity of extra and intracranial atherosclerosis. Intracranial stenoses will be assessed by magnetic resonance angiography (MRA). Clinical and demographic variables will be recorded and blood samples will be drawn to investigate clinical, biological and genetic factors associated with the presence of ASIA. A long-term clinical and sonographic follow-up will be conducted thereafter to identify predictors of disease progression and of incident vascular events. The Barcelona-ASIA is a population-based study aiming to evaluate the prevalence and clinical importance of asymptomatic intracranial large-artery atherosclerosis in Caucasians. The ASIA project may provide a unique scientific resource to better understand the dynamics of intracranial atherosclerosis from

  15. The Scandinavian baltic pancreatic club (SBPC) database: design, rationale and characterisation of the study cohort.

    Science.gov (United States)

    Olesen, Søren S; Poulsen, Jakob L; Drewes, Asbjørn M; Frøkjær, Jens B; Laukkarinen, Johanna; Parhiala, Mikael; Rix, Iben; Novovic, Srdan; Lindkvist, Björn; Bexander, Louise; Dimcevski, Georg; Engjom, Trond; Erchinger, Friedemann; Haldorsen, Ingfrid S; Pukitis, Aldis; Ozola-Zālīte, Imanta; Haas, Stephan; Vujasinovic, Miroslav; Löhr, J Matthias; Gulbinas, Antanas; Jensen, Nanna M; Jørgensen, Maiken T; Nøjgaard, Camilla

    2017-08-01

    Chronic pancreatitis (CP) is a multifaceted disease associated with several risk factors and a complex clinical presentation. We established the Scandinavian Baltic Pancreatic Club (SBPC) Database to characterise and study the natural history of CP in a Northern European cohort. Here, we describe the design of the database and characteristics of the study cohort. Nine centres from six different countries in the Scandinavian-Baltic region joined the database. Patients with definitive or probable CP (M-ANNHEIM diagnostic criteria) were included. Standardised case report forms were used to collect several assessment variables including disease aetiology, duration of CP, preceding acute pancreatitis, as well as symptoms, complications, and treatments. The clinical stage of CP was characterised according to M-ANNNHEIM. Yearly follow-up is planned for all patients. The study cohort comprised of 910 patients (608 men: 302 women; median age 58 (IQR: 48-67) years with definite 848 (93%) or probable CP 62 (7%). Nicotine (70%) and alcohol (59%) were the most frequent aetiologies and seen in combination in 44% of patients. A history of recurrent acute pancreatitis was seen in 49% prior to the development of CP. Pain (69%) and exocrine pancreatic insufficiency (68%) were the most common complications followed by diabetes (43%). Most patients (30%) were classified as clinical stage II (symptomatic CP with exocrine or endocrine insufficiency). Less than 10% of the patients had undergone pancreatic surgery. The SBPC database provides a mean for future prospective, observational studies of CP in the Northern European continent.

  16. Supplementation of iron in pulmonary hypertension: Rationale and design of a phase II clinical trial in idiopathic pulmonary arterial hypertension

    Science.gov (United States)

    Howard, Luke S.G.E.; Watson, Geoffrey M.J.; Wharton, John; Rhodes, Christopher J.; Chan, Kakit; Khengar, Rajeshree; Robbins, Peter A.; Kiely, David G.; Condliffe, Robin; Elliott, Charlie A.; Pepke-Zaba, Joanna; Sheares, Karen; Morrell, Nicholas W.; Davies, Rachel; Ashby, Deborah; Gibbs, J. Simon R.; Wilkins, Martin R.

    2013-01-01

    Our aim is to assess the safety and potential clinical benefit of intravenous iron (Ferinject) infusion in iron deficient patients with idiopathic pulmonary arterial hypertension (IPAH). Iron deficiency in the absence of anemia (1) is common in patients with IPAH; (2) is associated with inappropriately raised levels of hepcidin, the key regulator of iron homeostasis; and (3) correlates with disease severity and worse clinical outcomes. Oral iron absorption may be impeded by reduced absorption due to elevated hepcidin levels. The safety and benefits of parenteral iron replacement in IPAH are unknown. Supplementation of Iron in Pulmonary Hypertension (SIPHON) is a Phase II, multicenter, double-blind, randomized, placebo-controlled, crossover clinical trial of iron in IPAH. At least 60 patients will be randomized to intravenous ferric carboxymaltose (Ferinject) or saline placebo with a crossover point after 12 weeks of treatment. The primary outcome will be the change in resting pulmonary vascular resistance from baseline at 12 weeks, measured by cardiac catheterization. Secondary measures include resting and exercise hemodynamics and exercise performance from serial bicycle incremental and endurance cardiopulmonary exercise tests. Other secondary measurements include serum iron indices, 6-Minute Walk Distance, WHO functional class, quality of life score, N-terminal pro-brain natriuretic peptide (NT-proBNP), and cardiac anatomy and function from cardiac magnetic resonance. We propose that intravenous iron replacement will improve hemodynamics and clinical outcomes in IPAH. If the data supports a potentially useful therapeutic effect and suggest this drug is safe, the study will be used to power a Phase III study to address efficacy. PMID:23662181

  17. Evaluation oF FactORs ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD: Design and Rationale of the EFFORTLESS S-ICD Registry

    DEFF Research Database (Denmark)

    Pedersen, Susanne S; Lambiase, Pier; Boersma, Lucas V A

    2012-01-01

    utilization. Methods: The Registry is an observational, nonrandomized, standard of care evaluation to be conducted at approximately 50 investigational centers in Europe and New Zealand where the S-ICD is approved for use and distribution. Clinical Registry endpoints include perioperative (30 days postimplant......Background: Leads in and on the heart of the transvenous implantable cardioverter defibrillator (ICD) form the Achilles' heel of this system due to potential for peri- and postimplant complications. The S-ICD is a newer generation of the ICD that does not require leads on the heart...... or in the vasculature. We present the rationale and study design of the Evaluation oF FactORs ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD (EFFORTLESS S-ICD) Registry which was designed to evaluate the long-term performance of the S-ICD including patient quality of life and long-term resource...

  18. Living with diabetes: rationale, study design and baseline characteristics for an Australian prospective cohort study

    Directory of Open Access Journals (Sweden)

    Donald Maria

    2012-01-01

    Full Text Available Abstract Background Diabetes mellitus is a major global public health threat. In Australia, as elsewhere, it is responsible for a sizeable portion of the overall burden of disease, and significant costs. The psychological and social impact of diabetes on individuals with the disease can be severe, and if not adequately addressed, can lead to the worsening of the overall disease picture. The Living With Diabetes Study aims to contribute to a holistic understanding of the psychological and social aspects of diabetes mellitus. Methods/Design The Living With Diabetes Study is a 5-year prospective cohort study, based in Queensland, Australia. The first wave of data, which was collected via a mailed self-report survey, was gathered in 2008, with annual collections thereafter. Measurements include: demographic, lifestyle, health and disease characteristics; quality of life (EQ-5D, ADDQoL; emotional well-being (CES-D, LOT-R, ESSI; disease self-management (PAM; and health-care utilisation and patient-assessed quality of care (PACIC. 29% of the 14,439 adults who were invited to participate in the study agreed to do so, yielding a sample size of 3,951 people. Discussion The data collected by the Living With Diabetes Study provides a good representation of Australians with diabetes to follow over time in order to better understand the natural course of the illness. The study has potential to further illuminate, and give a comprehensive picture of the psychosocial implications of living with diabetes. Data collection is ongoing.

  19. Rationale and study design of the Japan environment and children's study (JECS).

    Science.gov (United States)

    Kawamoto, Toshihiro; Nitta, Hiroshi; Murata, Katsuyuki; Toda, Eisaku; Tsukamoto, Naoya; Hasegawa, Manabu; Yamagata, Zentaro; Kayama, Fujio; Kishi, Reiko; Ohya, Yukihiro; Saito, Hirohisa; Sago, Haruhiko; Okuyama, Makiko; Ogata, Tsutomu; Yokoya, Susumu; Koresawa, Yuji; Shibata, Yasuyuki; Nakayama, Shoji; Michikawa, Takehiro; Takeuchi, Ayano; Satoh, Hiroshi

    2014-01-10

    There is global concern over significant threats from a wide variety of environmental hazards to which children face. Large-scale and long-term birth cohort studies are needed for better environmental management based on sound science. The primary objective of the Japan Environment and Children's Study (JECS), a nation-wide birth cohort study that started its recruitment in January 2011, is to elucidate environmental factors that affect children's health and development. Approximately 100,000 expecting mothers who live in designated study areas will be recruited over a 3-year period from January 2011. Participating children will be followed until they reach 13 years of age. Exposure to environmental factors will be assessed by chemical analyses of bio-specimens (blood, cord blood, urine, breast milk, and hair), household environment measurements, and computational simulations using monitoring data (e.g. ambient air quality monitoring) as well as questionnaires. JECS' priority outcomes include reproduction/pregnancy complications, congenital anomalies, neuropsychiatric disorders, immune system disorders, and metabolic/endocrine system disorders. Genetic factors, socioeconomic status, and lifestyle factors will also be examined as covariates and potential confounders. To maximize representativeness, we adopted provider-mediated community-based recruitment. Through JECS, chemical substances to which children are exposed during the fetal stage or early childhood will be identified. The JECS results will be translated to better risk assessment and management to provide healthy environment for next generations.

  20. Rationale and study design of the Japan environment and children’s study (JECS)

    Science.gov (United States)

    2014-01-01

    Background There is global concern over significant threats from a wide variety of environmental hazards to which children face. Large-scale and long-term birth cohort studies are needed for better environmental management based on sound science. The primary objective of the Japan Environment and Children’s Study (JECS), a nation-wide birth cohort study that started its recruitment in January 2011, is to elucidate environmental factors that affect children’s health and development. Methods/Design Approximately 100,000 expecting mothers who live in designated study areas will be recruited over a 3-year period from January 2011. Participating children will be followed until they reach 13 years of age. Exposure to environmental factors will be assessed by chemical analyses of bio-specimens (blood, cord blood, urine, breast milk, and hair), household environment measurements, and computational simulations using monitoring data (e.g. ambient air quality monitoring) as well as questionnaires. JECS’ priority outcomes include reproduction/pregnancy complications, congenital anomalies, neuropsychiatric disorders, immune system disorders, and metabolic/endocrine system disorders. Genetic factors, socioeconomic status, and lifestyle factors will also be examined as covariates and potential confounders. To maximize representativeness, we adopted provider-mediated community-based recruitment. Discussion Through JECS, chemical substances to which children are exposed during the fetal stage or early childhood will be identified. The JECS results will be translated to better risk assessment and management to provide healthy environment for next generations. PMID:24410977

  1. Critical review of norovirus surrogates in food safety research: rationale for considering volunteer studies.

    Science.gov (United States)

    Richards, Gary P

    2012-03-01

    The inability to propagate human norovirus (NoV) or to clearly differentiate infectious from noninfectious virus particles has led to the use of surrogate viruses, like feline calicivirus (FCV) and murine norovirus-1 (MNV), which are propagatable in cell culture. The use of surrogates is predicated on the assumption that they generally mimic the viruses they represent; however, studies are proving this concept invalid. In direct comparisons between FCV and MNV, their susceptibility to temperatures, environmental and food processing conditions, and disinfectants are dramatically different. Differences have also been noted between the inactivation of NoV and its surrogates, thus questioning the validity of surrogates. Considerable research funding is provided globally each year to conduct surrogate studies on NoVs; however, there is little demonstrated benefit derived from these studies in regard to the development of virus inactivation techniques or food processing strategies. Human challenge studies are needed to determine which processing techniques are effective in reducing NoVs in foods. A major obstacle to clinical trials on NoVs is the perception that such trials are too costly and risky, but in reality, there is far more cost and risk in allowing millions of unsuspecting consumers to contract NoV illness each year, when practical interventions are only a few volunteer studies away. A number of clinical trials have been conducted, providing important insights into NoV inactivation. A shift in research priorities from surrogate research to volunteer studies is essential if we are to identify realistic, practical, and scientifically valid processing approaches to improve food safety.

  2. Rationale and design of a multicenter randomized clinical trial with memantine and dextromethorphan in ketamine-responder patients.

    Science.gov (United States)

    Pickering, Gisèle; Pereira, Bruno; Morel, Véronique; Tiberghien, Florence; Martin, Elodie; Marcaillou, Fabienne; Picard, Pascale; Delage, Noémie; de Montgazon, Géraldine; Sorel, Marc; Roux, Delphine; Dubray, Claude

    2014-07-01

    The N-methyl-D-aspartate receptor plays an important role in central sensitization of neuropathic pain and N-methyl-D-aspartate receptor antagonists, such as ketamine, memantine and dextromethorphan may be used for persistent pain. However, ketamine cannot be repeated too often because of its adverse events. A drug relay would be helpful in the outpatient to postpone or even cancel the next ketamine infusion. This clinical trial evaluates if memantine and/or dextromethorphan given as a relay to ketamine responders may maintain or induce a decrease of pain intensity and have a beneficial impact on cognition and quality of life. This trial is a multi-center, randomized, controlled and single-blind clinical study (NCT01602185). It includes 60 ketamine responder patients suffering from neuropathic pain. They are randomly allocated to memantine, dextromethorphan or placebo. After ketamine infusion, 60 patients received either memantine (maximal dose 20 mg/day), or dextromethorphan (maximal dose 90 mg/day), or placebo for 12 weeks. The primary endpoint is pain measured on a (0-10) Numeric Rating Scale 1 month after inclusion. Secondary outcomes include assessment of neuropathic pain, sleep, quality of life, anxiety/depression and cognitive function at 2 and 3 months. Data analysis is performed using mixed models and the tests are two-sided, with a type I error set at α=0.05. This study will explore if oral memantine and/or dextromethorphan may be a beneficial relay in ketamine responders and may diminish ketamine infusion frequency. Preservation of cognitive function and quality of life is also a central issue that will be analyzed in these vulnerable patients. Copyright © 2014. Published by Elsevier Inc.

  3. Rationale and design of the screening of pulmonary hypertension in systemic lupus erythematosus (SOPHIE) study.

    Science.gov (United States)

    Huang, Duo; Cheng, Yang-Yang; Chan, Pak-Hei; Hai, Jojo; Yiu, Kai-Hang; Tse, Hung-Fat; Wong, Ka-Lam; Fan, Katherine; Li, Ying Wah; Ng, Woon-Leung; Yim, Cheuk-Wan; Wong, Cheuk-Hon John; Tam, Lai-Shan; Wong, Priscilla C H; Wong, Chi-Yuen; Ho, Chup-Hei; Leung, Alexander M H; Mok, Chi-Chiu; Lam, Ho; Lau, Chak-Sing; Cheung, Tommy; Ho, Carmen; Law, Sharon W Y; Chan, Esther W; Yin, Li-Xue; Yue, Wen-Sheng; Mok, Toi Meng; Evora, Mario Alberto; Siu, Chung-Wah

    2018-01-01

    Current guideline-recommended screening for pulmonary hypertension in patients with systemic sclerosis has not been evaluated in systemic lupus erythematosus (SLE), which is disproportionately prevalent in Asians. This multicentre, cross-sectional screening study aims to study the prevalence of pulmonary hypertension among SLE patients using these guidelines, and identify independent predictors and develop a prediction model for pulmonary hypertension in SLE patients. SLE patients from participating centres will undergo an echocardiography- and biomarker-based pulmonary hypertension screening procedure as in the DETECT study. Standard right heart catheterisation will be provided to patients with intermediate or high echocardiographic probability of pulmonary hypertension. Those with low echocardiographic probability will rescreen within 1 year. The primary measure will be the diagnosis and types of pulmonary hypertension and prevalence of pulmonary hypertension in SLE patients. The secondary measures will be the predictors and prediction models for pulmonary hypertension in SLE patients. The estimated sample size is approximately 895 participants. The results of the SOPHIE study will be an important contribution to the literature of SLE-related pulmonary hypertension and may be immediately translatable to real clinical practice. Ultimately, this study will provide the necessary evidence for establishing universal guidelines for screening of pulmonary hypertension in SLE patients.

  4. Conceptual design studies for the European DEMO divertor: Rationale and first results

    International Nuclear Information System (INIS)

    You, J.H.; Mazzone, G.; Visca, E.; Bachmann, Ch.; Autissier, E.; Barrett, T.; Cocilovo, V.; Crescenzi, F.; Domalapally, P.K.; Dongiovanni, D.; Entler, S.; Federici, G.; Frosi, P.; Fursdon, M.; Greuner, H.; Hancock, D.; Marzullo, D.; McIntosh, S.; Müller, A.V.; Porfiri, M.T.

    2016-01-01

    Highlights: • A brief overview is given on the overall R&D activities of the work package Divertor which is a project of the EUROfusion Consortium. • The rationale of the hydraulic, thermal and structural design scheme is described. • The first results obtained for the preliminary DEMO divertor cassette model are presented. - Abstract: In the European fusion roadmap, reliable power handling has been defined as one of the most critical challenges for realizing a commercially viable fusion power. In this context, the divertor is the key in-vessel component, as it is responsible for power exhaust and impurity removal for which divertor target is subjected to very high heat flux loads. To this end, an integrated R&D project was launched in the EUROfusion Consortium in order to deliver a holistic conceptual design solution together with the core technologies for the entire divertor system of a DEMO reactor. The work package ‘Divertor’ consists of two project areas: ‘Cassette design and integration’ and ‘Target development’. The essential mission of the project is to develop and verify advanced design concepts and the required technologies for a divertor system being capable of meeting the physical and system requirements defined for the next-generation European DEMO reactor. In this contribution, a brief overview is presented of the works from the first project year (2014). Focus is put on the loads specification, design boundary conditions, materials requirements, design approaches, and R&D strategy. Initial ideas and first estimates are presented.

  5. Conceptual design studies for the European DEMO divertor: Rationale and first results

    Energy Technology Data Exchange (ETDEWEB)

    You, J.H., E-mail: you@ipp.mpg.de [Max Planck Institute for Plasma Physics, Boltzmann Str. 2, 85748 Garching (Germany); Mazzone, G.; Visca, E. [ENEA, Unità Tecnica Fusione, ENEA C. R. Frascati, via E. Fermi 45, 00044 Frascati (Italy); Bachmann, Ch. [EUROfusion PMU, c/o IPP, Boltzmann Str. 2, 85748 Garching (Germany); Autissier, E. [CEA, IRFM, F-13108 Saint Paul Lez Durance (France); Barrett, T. [CCFE, Culham Science Centre, Abingdon OX14 3DB (United Kingdom); Cocilovo, V.; Crescenzi, F. [ENEA, Unità Tecnica Fusione, ENEA C. R. Frascati, via E. Fermi 45, 00044 Frascati (Italy); Domalapally, P.K. [Research Cnter Rez, Hlavní 130, 250 68 Husinec–Řež (Czech Republic); Dongiovanni, D. [ENEA, Unità Tecnica Fusione, ENEA C. R. Frascati, via E. Fermi 45, 00044 Frascati (Italy); Entler, S. [Institute of Plasma Physics CAS, Za Slovankou 3, 182 00 Praha 8 (Czech Republic); Federici, G. [EUROfusion PMU, c/o IPP, Boltzmann Str. 2, 85748 Garching (Germany); Frosi, P. [ENEA, Unità Tecnica Fusione, ENEA C. R. Frascati, via E. Fermi 45, 00044 Frascati (Italy); Fursdon, M. [CCFE, Culham Science Centre, Abingdon OX14 3DB (United Kingdom); Greuner, H. [Max Planck Institute for Plasma Physics, Boltzmann Str. 2, 85748 Garching (Germany); Hancock, D. [CCFE, Culham Science Centre, Abingdon OX14 3DB (United Kingdom); Marzullo, D. [CREATE, University of Naples Federico II, P.le Tecchio 80, 80125 Napoli (Italy); McIntosh, S. [CCFE, Culham Science Centre, Abingdon OX14 3DB (United Kingdom); Müller, A.V. [Max Planck Institute for Plasma Physics, Boltzmann Str. 2, 85748 Garching (Germany); Porfiri, M.T. [ENEA, Unità Tecnica Fusione, ENEA C. R. Frascati, via E. Fermi 45, 00044 Frascati (Italy); and others

    2016-11-01

    Highlights: • A brief overview is given on the overall R&D activities of the work package Divertor which is a project of the EUROfusion Consortium. • The rationale of the hydraulic, thermal and structural design scheme is described. • The first results obtained for the preliminary DEMO divertor cassette model are presented. - Abstract: In the European fusion roadmap, reliable power handling has been defined as one of the most critical challenges for realizing a commercially viable fusion power. In this context, the divertor is the key in-vessel component, as it is responsible for power exhaust and impurity removal for which divertor target is subjected to very high heat flux loads. To this end, an integrated R&D project was launched in the EUROfusion Consortium in order to deliver a holistic conceptual design solution together with the core technologies for the entire divertor system of a DEMO reactor. The work package ‘Divertor’ consists of two project areas: ‘Cassette design and integration’ and ‘Target development’. The essential mission of the project is to develop and verify advanced design concepts and the required technologies for a divertor system being capable of meeting the physical and system requirements defined for the next-generation European DEMO reactor. In this contribution, a brief overview is presented of the works from the first project year (2014). Focus is put on the loads specification, design boundary conditions, materials requirements, design approaches, and R&D strategy. Initial ideas and first estimates are presented.

  6. ACCISS study rationale and design: activating collaborative cancer information service support for cervical cancer screening

    Directory of Open Access Journals (Sweden)

    Bullard Emily

    2009-12-01

    Full Text Available Abstract Background High-quality cancer information resources are available but underutilized by the public. Despite greater awareness of the National Cancer Institute's Cancer Information Service among low-income African Americans and Hispanics compared with Caucasians, actual Cancer Information Service usage is lower than expected, paralleling excess cancer-related morbidity and mortality for these subgroups. The proposed research examines how to connect the Cancer Information Service to low-income African-American and Hispanic women and their health care providers. The study will examine whether targeted physician mailing to women scheduled for colposcopy to follow up an abnormal Pap test can increase calls to the Cancer Information Service, enhance appropriate medical follow-up, and improve satisfaction with provider-patient communication. Methods/Design The study will be conducted in two clinics in ethnically diverse low-income communities in Chicago. During the formative phase, patients and providers will provide input regarding materials planned for use in the experimental phase of the study. The experimental phase will use a two-group prospective randomized controlled trial design. African American and Hispanic women with an abnormal Pap test will be randomized to Usual Care (routine colposcopy reminder letter or Intervention (reminder plus provider recommendation to call the Cancer Information Service and sample questions to ask. Primary outcomes will be: 1 calls to the Cancer Information Service; 2 timely medical follow-up, operationalized by whether the patient keeps her colposcopy appointment within six months of the abnormal Pap; and 3 patient satisfaction with provider-patient communication at follow-up. Discussion The study examines the effectiveness of a feasible, sustainable, and culturally sensitive strategy to increase awareness and use of the Cancer Information Service among an underserved population. The goal of linking a

  7. ACCISS study rationale and design: activating collaborative cancer information service support for cervical cancer screening.

    Science.gov (United States)

    Cofta-Woerpel, Ludmila; Randhawa, Veenu; McFadden, H Gene; Fought, Angela; Bullard, Emily; Spring, Bonnie

    2009-12-02

    High-quality cancer information resources are available but underutilized by the public. Despite greater awareness of the National Cancer Institute's Cancer Information Service among low-income African Americans and Hispanics compared with Caucasians, actual Cancer Information Service usage is lower than expected, paralleling excess cancer-related morbidity and mortality for these subgroups. The proposed research examines how to connect the Cancer Information Service to low-income African-American and Hispanic women and their health care providers. The study will examine whether targeted physician mailing to women scheduled for colposcopy to follow up an abnormal Pap test can increase calls to the Cancer Information Service, enhance appropriate medical follow-up, and improve satisfaction with provider-patient communication. The study will be conducted in two clinics in ethnically diverse low-income communities in Chicago. During the formative phase, patients and providers will provide input regarding materials planned for use in the experimental phase of the study. The experimental phase will use a two-group prospective randomized controlled trial design. African American and Hispanic women with an abnormal Pap test will be randomized to Usual Care (routine colposcopy reminder letter) or Intervention (reminder plus provider recommendation to call the Cancer Information Service and sample questions to ask). Primary outcomes will be: 1) calls to the Cancer Information Service; 2) timely medical follow-up, operationalized by whether the patient keeps her colposcopy appointment within six months of the abnormal Pap; and 3) patient satisfaction with provider-patient communication at follow-up. The study examines the effectiveness of a feasible, sustainable, and culturally sensitive strategy to increase awareness and use of the Cancer Information Service among an underserved population. The goal of linking a public service (the Cancer Information Service) with real

  8. Non-Hematopoietic Essential Functions of Bone Marrow Cells: A Review of Scientific and Clinical Literature and Rationale for Treating Bone Defects.

    Science.gov (United States)

    Harrell, David B; Caradonna, Eugenio; Mazzucco, Laura; Gudenus, Rosmarie; Amann, Berthold; Prochazka, Vaclav; Giannoudis, Peter V; Hendrich, Christian; Jäger, Marcus; Krauspe, Rüdiger; Hernigou, Philippe

    2015-12-28

    Hematopoiesis as the only essential function of bone marrow cells has been challenged for several decades through basic science (in vitro and in vivo) and clinical data. Such work has shed light on two other essential functions of bone marrow cells: osteopoiesis and angio-genesis/vasculogenesis. Clinical utility of autologous concentrated bone marrow aspirate (CBMA) has demonstrated both safety and efficacy in treating bone defects. Moreover, CBMA has been shown to be comparable to the gold standard of iliac crest bone graft (ICBG), or autograft, with regard to being osteogenic and osteoinductive. ICBG is not considered an advanced therapy medicinal product (ATMP), but CBMA may become regulated as an ATMP. The European Medicines Agency Committee for Advanced Therapies (EMA:CAT) has issued a reflection paper (20 June 2014) in which reversal of the 2013 ruling that CBMA is a non-ATMP has been proposed. We review bone marrow cell involvement in osteopoiesis and angiogenesis/vasculogenesis to examine EMA:CAT 2013 decision to use CBMA for treatment of osteonecrosis (e.g, of the femoral head) should be considered a non-ATMP. This paper is intended to provide discussion on the 20 June 2014 reflection paper by reviewing two non-hematopoietic essential functions of bone marrow cells. Additionally, we provide clinical and scientific rationale for treating osteonecrosis with CBMA.

  9. Non-hematopoietic essential functions of bone marrow cells: a review of scientific and clinical literature and rationale for treating bone defects

    Directory of Open Access Journals (Sweden)

    David B. Harrell

    2015-12-01

    Full Text Available Hematopoiesis as the only essential function of bone marrow cells has been challenged for several decades through basic science (in vitro and in vivo and clinical data. Such work has shed light on two other essential functions of bone marrow cells: osteopoiesis and angiogenesis/vasculogenesis. Clinical utility of autologous concentrated bone marrow aspirate (CBMA has demonstrated both safety and efficacy in treating bone defects. Moreover, CBMA has been shown to be comparable to the gold standard of iliac crest bone graft (ICBG, or autograft, with regard to being osteogenic and osteoinductive. ICBG is not considered an advanced therapy medicinal product (ATMP, but CBMA may become regulated as an ATMP. The European Medicines Agency Committee for Advanced Therapies (EMA:CAT has issued a reflection paper (20 June 2014 in which reversal of the 2013 ruling that CBMA is a non-ATMP has been proposed. We review bone marrow cell involvement in osteopoiesis and angiogenesis/vasculogenesis to examine EMA:CAT 2013 decision to use CBMA for treatment of osteonecrosis (e.g, of the femoral head should be considered a non-ATMP. This paper is intended to provide discussion on the 20 June 2014 reflection paper by reviewing two non-hematopoietic essential functions of bone marrow cells. Additionally, we provide clinical and scientific rationale for treating osteonecrosis with CBMA.

  10. PROspective Multicenter Imaging Study for Evaluation of chest pain: rationale and design of the PROMISE trial.

    Science.gov (United States)

    Douglas, Pamela S; Hoffmann, Udo; Lee, Kerry L; Mark, Daniel B; Al-Khalidi, Hussein R; Anstrom, Kevin; Dolor, Rowena J; Kosinski, Andrzej; Krucoff, Mitchell W; Mudrick, Daniel W; Patel, Manesh R; Picard, Michael H; Udelson, James E; Velazquez, Eric J; Cooper, Lawton

    2014-06-01

    Suspected coronary artery disease (CAD) is one of the most common, potentially life-threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. The PROMISE study is a prospective, randomized trial comparing the effectiveness of 2 initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either (1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram) or (2) anatomical testing with ≥64-slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians, and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core laboratory quality and completeness assessment. All subjects are followed up for ≥1 year. The primary end point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis, and renal failure), or hospitalization for unstable angina. More than 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care, and anesthesiology sites. Multispecialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. The PROMISE trial will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomical testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost-effectiveness, and radiation exposure will be assessed. Copyright © 2014 Mosby, Inc. All rights reserved.

  11. Relationship between volition, physical activity and weight loss maintenance: Study rationale, design, methods and baseline characteristics.

    Science.gov (United States)

    Dandanell, Sune; Elbe, Anne-Marie; Pfister, Gertrud; Elsborg, Peter; W Helge, Jørn

    2017-05-01

    To investigate the relationship between volition, physical activity and weight loss maintenance. We recruited 84 sedentary (maximal oxygen uptake: 25 ± 5 ml/min), overweight and obese (Body mass index (BMI) 38 ± 7 m/h 2 , fat 44 ± 7 %) women ( n = 55) and men ( n = 29) for an interdisciplinary prospective study with follow-up. The change in lifestyle and weight loss is promoted via a 3-month intensive lifestyle intervention at a private health school. The intervention consists of supervised training (1-3 hours/day), a healthy hypo-caloric diet (-500 to -700 kCal/day) and education in healthy lifestyle in classes/groups. The participants' body weight and composition (Dual Energy X-ray absorptiometry), volitional skills (questionnaire), physical activity level (heart rate accelerometer/questionnaire) and maximal oxygen uptake (indirect calorimetry) are to be monitored before, after, and 3 and 12 months after the intervention. At the 12-month follow-up, three different groups will be established: Clinical weight loss maintenance (> 10% weight loss from baseline), moderate weight loss maintenance (1-10% weight loss) and no weight loss (or weight regain). A linear mixed model analysis will be used to compare levels of volitional skills, physical activity and maximal oxygen uptake over time, between the three groups. Correlational analyses will be used to investigate possible associations between volition, maximal oxygen uptake, physical activity level and weight loss maintenance. If specific volitional skills are identified as predictors of adherence to physical activity and success in clinical weight loss maintenance, these can be trained in future intensive lifestyle interventions in order to optimize the success rate.

  12. The Female Athlete Body (FAB) study: Rationale, design, and baseline characteristics.

    Science.gov (United States)

    Stewart, Tiffany M; Pollard, Tarryn; Hildebrandt, Tom; Beyl, Robbie; Wesley, Nicole; Kilpela, Lisa Smith; Becker, Carolyn Black

    2017-09-01

    Eating Disorders (EDs) are serious psychiatric illnesses marked by psychiatric comorbidity, medical complications, and functional impairment. Research indicates that female athletes are often at greater risk for developing ED pathology versus non-athlete females. The Female Athlete Body (FAB) study is a three-site, randomized controlled trial (RCT) designed to assess the efficacy of a behavioral ED prevention program for female collegiate athletes when implemented by community providers. This paper describes the design, intervention, and participant baseline characteristics. Future papers will discuss outcomes. Female collegiate athletes (N=481) aged 17-21 were randomized by site, team, and sport type to either FAB or a waitlist control group. FAB consisted of three sessions (1.3h each) of a behavioral ED prevention program. Assessments were conducted at baseline (pre-intervention), post-intervention (3weeks), and six-, 12-, and 18-month follow-ups. This study achieved 96% (N=481) of target recruitment (N=500). Few group differences emerged at baseline. Total sample analyses revealed moderately low baseline instances of ED symptoms and clinical cases. Health risks associated with EDs necessitate interventions for female athletes. The FAB study is the largest existing RCT for female athletes aimed at both reduction of ED risk factors and ED prevention. The methods presented and population recruited for this study represent an ideal intervention for assessing the effects of FAB on both the aforementioned outcomes. We anticipate that findings of this study (reported in future papers) will make a significant contribution to the ED risk factor reduction and prevention literature. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. Rationale and Design Issues of the Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) Study

    Science.gov (United States)

    Keren, Ron; Carpenter, Myra A.; Hoberman, Alejandro; Shaikh, Nader; Matoo, Tej K.; Chesney, Russell W.; Matthews, Ranjiv; Gerson, Arlene C.; Greenfield, Saul P.; Fivush, Barbara; McLurie, Gordon A.; Rushton, H. Gil; Canning, Douglas; Nelson, Caleb P.; Greenbaum, Lawrence; Bukowski, Timothy; Primack, William; Sutherland, Richard; Hosking, James; Stewart, Dawn; Elder, Jack; Moxey-Mims, Marva; Nyberg, Leroy

    2010-01-01

    OBJECTIVE Our goal is to determine if antimicrobial prophylaxis with trimethoprim/sulfamethoxazole prevents recurrent urinary tract infections and renal scarring in children who are found to have vesicoureteral reflux after a first or second urinary tract infection. DESIGN, PARTICIPANTS, AND METHODS The Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) study is a double-blind, randomized, placebo-controlled trial. Six hundred children aged 2 to 72 months will be recruited from both primary and subspecialty care settings at clinical trial centers throughout North America. Children who are found to have grades I to IV vesicoureteral reflux after the index febrile or symptomatic urinary tract infection will be randomly assigned to receive daily doses of either trimethoprim/sulfamethoxazole or placebo for 2 years. Scheduled follow-up contacts include in-person study visits every 6 months and telephone interviews every 2 months. Biospecimens (urine and blood) and genetic specimens (blood) will be collected for future studies of the genetic and biochemical determinants of vesicoureteral reflux, recurrent urinary tract infection, renal insufficiency, and renal scarring. RESULTS The primary outcome is recurrence of urinary tract infection. Secondary outcomes include time to recurrent urinary tract infection, renal scarring (assessed by dimercaptosuccinic acid scan), treatment failure, renal function, resource utilization, and development of antimicrobial resistance in stool flora. CONCLUSIONS The RIVUR study will provide useful information to clinicians about the risks and benefits of prophylactic antibiotics for children who are diagnosed with vesicoureteral reflux after a first or second urinary tract infection. The data and specimens collected over the course of the study will allow researchers to better understand the pathophysiology of recurrent urinary tract infection and its sequelae. PMID:19018048

  14. Design, rationale, and baseline demographics of SEARCH I: a prospective cluster-randomized study

    Directory of Open Access Journals (Sweden)

    Albers F

    2012-07-01

    Full Text Available Frank Albers,1 Asif Shaikh,2 Ahmar Iqbal,31Medical Affairs Respiratory, 2Clinical Development and Medical Affairs, Field Based Medicine-Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA; 3Respiratory Medical Affairs, Pfizer Inc, New York, NY, USAAbstract: Questionnaires are available to identify patients at risk for several chronic diseases, including COPD, but are infrequently utilized in primary care. COPD is often underdiagnosed, while at the same time the US Preventive Services Task Force recommends against spirometric screening for COPD in asymptomatic adults. Use of a symptom-based questionnaire and subsequent handheld spirometric device depending on the answers to the questionnaire is a promising approach to identify patients at risk for COPD. Screening, Evaluating and Assessing Rate CHanges of diagnosing respiratory conditions in primary care 1 (SEARCH I was a prospective cluster-randomized study in 168 US primary care practices evaluating the effect of the COPD-Population Screener (COPD-PS™ questionnaire. The effect of this questionnaire alone or sequentially with the handheld copd-6TM device was evaluated on new diagnoses of COPD and on respiratory diagnostic practice patterns (including referrals for pulmonary function testing, referrals to pulmonologists, new diagnoses of COPD, and new respiratory medication prescriptions. Participating practices entered a total of 9704 consecutive consenting subjects aged ≥ 40 years attending primary care clinics. Study arm results were compared for new COPD diagnosis rates between usual care and (1 COPD-PS plus copd-6 and (2 COPD-PS alone. A cluster-randomization design allowed comparison of the intervention effects at the practice level instead of individuals being the subjects of the intervention. Regional principal investigators controlled the flow of study information to sub-investigators at participating practices to reduce observation bias (Hawthorne effect. The

  15. Diet and lifestyle intervention among patients with colorectal adenomas: rationale and design of a Malaysian study.

    Science.gov (United States)

    Kandiah, Mirnalini; Ramadas, Amutha; Shariff, Zalilah Mohd; Yusof, Rokiah Mohd; Gul, Yunus Gul Alif

    2005-01-01

    Comprehensive evaluation of the large body of consistent evidence from laboratory, epidemiologic and clinical studies has led to the conclusion that modification of the dietary and lifestyle patterns of populations has considerable potential for reducing cancer risk. This paper describes a randomized-controlled trial involving a diet and lifestyle intervention for patients with history of colorectal adenomas. The primary aim of this trial is to evaluate the effectiveness of the intervention with reference to recurrence of adenomatous polyps over a two year period--the first year being the intervention period and the second year of the study allowing for post-intervention follow-up. Subjects found to fit the inclusion criteria are recruited and randomized to two groups: the intervention group and the control group. The intervention group subjects will attend a monthly lecture-discussion session for 10 months and small group counseling on modification of lifestyle behavior and diet as well as receive educational materials which were adapted from the WCRF Diet and Health Recommendations for Cancer Prevention. Control subjects will be provided with the usual care given to such patients. One hundred and sixteen patients who were diagnosed with colorectal adenomatous polyps in the previous twelve months at the Hospital Kuala Lumpur have already been enrolled in this trial. Baseline data collection is on-going.

  16. ENabling Reduction of Low-grade Inflammation in SEniors Pilot Study: Concept, Rationale, and Design.

    Science.gov (United States)

    Manini, Todd M; Anton, Stephen D; Beavers, Daniel P; Cauley, Jane A; Espeland, Mark A; Fielding, Roger A; Kritchevsky, Stephen B; Leeuwenburgh, Christiaan; Lewis, Kristina H; Liu, Christine; McDermott, Mary M; Miller, Michael E; Tracy, Russell P; Walston, Jeremy D; Radziszewska, Barbara; Lu, Jane; Stowe, Cindy; Wu, Samuel; Newman, Anne B; Ambrosius, Walter T; Pahor, Marco

    2017-09-01

    To test two interventions to reduce interleukin (IL)-6 levels, an indicator of low-grade chronic inflammation and an independent risk factor for impaired mobility and slow walking speed in older adults. The ENabling Reduction of low-Grade Inflammation in SEniors (ENRGISE) Pilot Study was a multicenter, double-blind, placebo-controlled randomized pilot trial of two interventions to reduce IL-6 levels. Five university-based research centers. Target enrollment was 300 men and women aged 70 and older with an average plasma IL-6 level between 2.5 and 30 pg/mL measured twice at least 1 week apart. Participants had low to moderate physical function, defined as self-reported difficulty walking one-quarter of a mile or climbing a flight of stairs and usual walk speed of less than 1 m/s on a 4-m usual-pace walk. Participants were randomized to losartan, omega-3 fish oil (ω-3), combined losartan and ω-3, or placebo. Randomization was stratified depending on eligibility for each group. A titration schedule was implemented to reach a dose that was safe and effective for IL-6 reduction. Maximal doses were 100 mg/d for losartan and 2.8 g/d for ω-3. IL-6, walking speed over 400 m, physical function (Short Physical Performance Battery), other inflammatory markers, safety, tolerability, frailty domains, and maximal leg strength were measured. Results from the ENRGISE Pilot Study will provide recruitment yields, feasibility, medication tolerance and adherence, and preliminary data to help justify a sample size for a more definitive randomized trial. The ENRGISE Pilot Study will inform a larger subsequent trial that is expected to have important clinical and public health implications for the growing population of older adults with low-grade chronic inflammation and mobility limitations. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

  17. The Japan Statin Treatment Against Recurrent Stroke (J-STARS) Echo Study: Rationale and Trial Protocol.

    Science.gov (United States)

    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.

  18. Rationale, design and baseline results of the Treatment Optimisation in Primary care of Heart failure in the Utrecht region (TOPHU) study : a cluster randomised controlled trial

    NARCIS (Netherlands)

    Valk, Mark J.; Hoes, Arno W.; Mosterd, Arend; Landman, Marcel A.; Broekhuizen, Berna D L; Rutten, Frans H.

    2015-01-01

    BACKGROUND: Heart failure (HF) is mainly detected and managed in primary care, but the care is considered suboptimal. We present the rationale, design and baseline results of the Treatment Optimisation in Primary care of Heart failure in the Utrecht region (TOPHU) study. In this study we assess the

  19. The dual trigger study: Rationale and study design of a prospective double-blind randomized clinical trial comparing pregnancy rates after co-administration of low dose hCG at the time of GnRH agonist trigger or 35 h later for the prevention of OHSS

    Directory of Open Access Journals (Sweden)

    Daniel Griffin

    2017-12-01

    Full Text Available Ovarian hyperstimulation syndrome (OHSS is an iatrogenic complication of controlled ovarian stimulation. The use of gonadotropin releasing hormone (GnRH agonist for the trigger of oocyte maturation is effective in the prevention of OHSS although it may result in a lower pregnancy rate. The use of adjuvant low dose human chorionic gonadotropin (hCG at the time of trigger or at the time of oocyte retrieval may improve pregnancy rates. The goal of this dual trigger study is to evaluate the safety and efficacy of the use of low dose hCG administered at the time of GnRH agonist trigger or 35 h later as well as the potential impact on pregnancy rates. The population will consist of 82 women undergoing IVF treatment who are at risk of developing OHSS. This study will be a single center prospective randomized double-blind placebo controlled trial. The randomization schedule will be administered by the Investigational Drug Services of the University. After controlled ovarian stimulation, induction of oocyte maturation will be achieved using a GnRH agonist and patients will be randomized to receive either low dose hCG 1000 IU at the time of trigger and placebo at oocyte retrieval (Study group or placebo at the time of trigger and hCG 1500 IU at the time of oocyte retrieval (Control group. The main outcomes will be live birth rates and incidence of OHSS. Two ancillary studies will include a quality of life survey and serum assessment of independent corpus luteum function.

  20. A Proposed Multisite Double-Blind Randomized Clinical Trial of Neurofeedback for ADHD: Need, Rationale, and Strategy

    Science.gov (United States)

    Kerson, Cynthia

    2013-01-01

    Objective: Additional treatments with persisting benefit are needed for ADHD. Because ADHD often shows excessive theta electroencephalogram (EEG) power, low beta, and excessive theta-beta ratio (TBR), a promising treatment is neurofeedback (NF) downtraining TBR. Although several nonblind randomized clinical trials (RCTs) show a medium-large…

  1. Prolactinomas : clinical studies

    NARCIS (Netherlands)

    Kars, Marleen

    2008-01-01

    Prolactinoma are treated with dopamine agonists, which are effective in reducing prolactin and tumor size. Studies reporting clinical and radiological outcome are scarce. The study described in chapter 2, assesses long-term outcome in patients treated with dopamine agonists for macroprolactinoma. An

  2. Cost-effectiveness of home telemonitoring in chronic kidney disease patients at different stages by a pragmatic randomized controlled trial (eNephro): rationale and study design.

    Science.gov (United States)

    Thilly, Nathalie; Chanliau, Jacques; Frimat, Luc; Combe, Christian; Merville, Pierre; Chauveau, Philippe; Bataille, Pierre; Azar, Raymond; Laplaud, David; Noël, Christian; Kessler, Michèle

    2017-04-05

    Home telemonitoring has developed considerably over recent years in chronic diseases in order to improve communication between healthcare professionals and patients and to promote early detection of deteriorating health status. In the nephrology setting, home telemonitoring has been evaluated in home dialysis patients but data are scarce concerning chronic kidney disease (CKD) patients before and after renal replacement therapy. The eNephro study is designed to assess the cost effectiveness, clinical/biological impact, and patient perception of a home telemonitoring for CKD patients. Our purpose is to present the rationale, design and organisational aspects of this study. eNephro is a pragmatic randomised controlled trial, comparing home telemonitoring versus usual care in three populations of CKD patients: stage 3B/4 (n = 320); stage 5D CKD on dialysis (n = 260); stage 5 T CKD treated with transplantation (n= 260). Five hospitals and three not-for-profit providers managing self-care dialysis situated in three administrative regions in France are participating. The trial began in December 2015, with a scheduled 12-month inclusion period and 12 months follow-up. Outcomes include clinical and biological data (e.g. blood pressure, haemoglobin) collected from patient records, perceived health status (e.g. health related quality of life) collected from self-administered questionnaires, and health expenditure data retrieved from the French health insurance database (SNIIRAM) using a probabilistic matching procedure. The hypothesis is that home telemonitoring enables better control of clinical and biological parameters as well as improved perceived health status. This better control should limit emergency consultations and hospitalisations leading to decreased healthcare expenditure, compensating for the financial investment due to the telemedicine system. This study has been registered at ClinicalTrials.gov under NCT02082093 (date of registration: February 14

  3. Electroencephalography (EEG) for neurological prognostication after cardiac arrest and targeted temperature management; rationale and study design.

    Science.gov (United States)

    Westhall, Erik; Rosén, Ingmar; Rossetti, Andrea O; van Rootselaar, Anne-Fleur; Kjaer, Troels Wesenberg; Horn, Janneke; Ullén, Susann; Friberg, Hans; Nielsen, Niklas; Cronberg, Tobias

    2014-08-16

    Electroencephalography (EEG) is widely used to assess neurological prognosis in patients who are comatose after cardiac arrest, but its value is limited by varying definitions of pathological patterns and by inter-rater variability. The American Clinical Neurophysiology Society (ACNS) has recently proposed a standardized EEG-terminology for critical care to address these limitations. In the TTM-trial, 399 post cardiac arrest patients who remained comatose after rewarming underwent a routine EEG. The presence of clinical seizures, use of sedatives and antiepileptic drugs during the EEG-registration were prospectively documented. A well-defined terminology for interpreting post cardiac arrest EEGs is critical for the use of EEG as a prognostic tool. The TTM-trial is registered at ClinicalTrials.gov (NCT01020916).

  4. The "BIOmarkers associated with Sarcopenia and PHysical frailty in EldeRly pErsons" (BIOSPHERE) study: Rationale, design and methods.

    Science.gov (United States)

    Calvani, Riccardo; Picca, Anna; Marini, Federico; Biancolillo, Alessandra; Cesari, Matteo; Pesce, Vito; Lezza, Angela Maria Serena; Bossola, Maurizio; Leeuwenburgh, Christiaan; Bernabei, Roberto; Landi, Francesco; Marzetti, Emanuele

    2018-05-10

    Sarcopenia, the progressive and generalised loss of muscle mass and strength/function, is a major health issue in older adults given its high prevalence and burdensome clinical implications. Over the years, this condition has been endorsed as a marker for discriminating biological from chronological age. However, the absence of a unified operational definition has hampered its full appreciation by healthcare providers, researchers and policy-makers. In addition to this unsolved debate, the complexity of musculoskeletal ageing represents a major challenge to the identification of clinically meaningful biomarkers. Here, we illustrate the advantages of biomarker discovery procedures in muscle ageing based on multivariate methodologies as an alternative approach to traditional single-marker strategies. The rationale, design and methods of the "BIOmarkers associated with Sarcopenia and PHysical frailty in EldeRly pErsons" (BIOSPHERE) study are described as an application of a multi-marker strategy for the development of biomarkers for the newly operationalised Physical Frailty & Sarcopenia condition. Copyright © 2018 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

  5. Rationale, design, and baseline characteristics of the CArdiovascular safety and Renal Microvascular outcomE study with LINAgliptin (CARMELINA®): a randomized, double-blind, placebo-controlled clinical trial in patients with type 2 diabetes and high cardio-renal risk.

    Science.gov (United States)

    Rosenstock, Julio; Perkovic, Vlado; Alexander, John H; Cooper, Mark E; Marx, Nikolaus; Pencina, Michael J; Toto, Robert D; Wanner, Christoph; Zinman, Bernard; Baanstra, David; Pfarr, Egon; Mattheus, Michaela; Broedl, Uli C; Woerle, Hans-Juergen; George, Jyothis T; von Eynatten, Maximilian; McGuire, Darren K

    2018-03-14

    Cardiovascular (CV) outcome trials in type 2 diabetes (T2D) have underrepresented patients with chronic kidney disease (CKD), leading to uncertainty regarding their kidney efficacy and safety. The CARMELINA ® trial aims to evaluate the effects of linagliptin, a DPP-4 inhibitor, on both CV and kidney outcomes in a study population enriched for cardio-renal risk. CARMELINA ® is a randomized, double-blind, placebo-controlled clinical trial conducted in 27 countries in T2D patients at high risk of CV and/or kidney events. Participants with evidence of CKD with or without CV disease and HbA1c 6.5-10.0% (48-86 mmol/mol) were randomized 1:1 to receive linagliptin once daily or matching placebo, added to standard of care adjusted according to local guidelines. The primary outcome is time to first occurrence of CV death, non-fatal myocardial infarction, or non-fatal stroke. The key secondary outcome is a composite of time to first sustained occurrence of end-stage kidney disease, ≥ 40% decrease in estimated glomerular filtration rate (eGFR) from baseline, or renal death. CV and kidney events are prospectively adjudicated by independent, blinded clinical event committees. CARMELINA ® was designed to continue until at least 611 participants had confirmed primary outcome events. Assuming a hazard ratio of 1.0, this provides 90% power to demonstrate non-inferiority of linagliptin versus placebo within the pre-specified non-inferiority margin of 1.3 at a one-sided α-level of 2.5%. If non-inferiority of linagliptin for the primary outcome is demonstrated, then its superiority for both the primary outcome and the key secondary outcome will be investigated with a sequentially rejective multiple test procedure. Between July 2013 and August 2016, 6980 patients were randomized and took ≥ 1 dose of study drug (40.6, 33.1, 16.9, and 9.4% from Europe, South America, North America, and Asia, respectively). At baseline, mean ± SD age was 65.8 ± 9.1 years, HbA1c

  6. Sodium-glucose cotransporter 2 inhibitors combined with dipeptidyl peptidase-4 inhibitors in the management of type 2 diabetes: a review of current clinical evidence and rationale

    Directory of Open Access Journals (Sweden)

    Yassin SA

    2017-03-01

    Full Text Available Sayf A Yassin,1 Vanita R Aroda2 1MedStar Union Memorial Hospital, Baltimore, 2MedStar Health Research Institute, Hyattsville, MD, USA Abstract: Type 2 diabetes mellitus (T2DM is a progressive and multifactorial cardiometabolic disorder. Almost half of adults with diabetes fail to achieve their recommended glucose control target. This has prompted some clinicians to advocate the use of more intensive initial therapy, including the use of combination therapy to target multiple physiologic defects in diabetes with the goal of achieving and sustaining glucose control. Numerous options exist for combining the various classes of glucose-lowering agents in the treatment of T2DM. This report reviews the mechanism, rationale, and evidence from clinical trials for combining two of the newer drug classes, namely, dipeptidyl peptidase-4 inhibitors and sodium-glucose cotransporter 2 inhibitors, and considers the possible role of such dual therapy in the management of T2DM. Keywords: sodium-glucose cotransporter 2 inhibitors, dipeptidyl peptidase-4 inhibitors, type 2 diabetes mellitus, combination therapy

  7. Study rationale and design of OPTIMISE, a randomised controlled trial on the effect of benchmarking on quality of care in type 2 diabetes mellitus

    Science.gov (United States)

    2011-01-01

    Background To investigate the effect of physician- and patient-specific feedback with benchmarking on the quality of care in adults with type 2 diabetes mellitus (T2DM). Methods Study centres in six European countries were randomised to either a benchmarking or control group. Physicians in both groups received feedback on modifiable outcome indicators (glycated haemoglobin [HbA1c], glycaemia, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein [LDL]-cholesterol and triglycerides) for each patient at 0, 4, 8 and 12 months, based on the four times yearly control visits recommended by international guidelines. The benchmarking group also received comparative results on three critical quality indicators of vascular risk (HbA1c, LDL-cholesterol and systolic blood pressure [SBP]), checked against the results of their colleagues from the same country, and versus pre-set targets. After 12 months of follow up, the percentage of patients achieving the pre-determined targets for the three critical quality indicators will be assessed in the two groups. Results Recruitment was completed in December 2008 with 3994 evaluable patients. Conclusions This paper discusses the study rationale and design of OPTIMISE, a randomised controlled study, that will help assess whether benchmarking is a useful clinical tool for improving outcomes in T2DM in primary care. Trial registration NCT00681850 PMID:21939502

  8. Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design

    Directory of Open Access Journals (Sweden)

    Cho Alex H

    2012-01-01

    Full Text Available Abstract Background Type 2 diabetes is a prevalent chronic condition globally that results in extensive morbidity, decreased quality of life, and increased health services utilization. Lifestyle changes can prevent the development of diabetes, but require patient engagement. Genetic risk testing might represent a new tool to increase patients' motivation for lifestyle changes. Here we describe the rationale, development, and design of a randomized controlled trial (RCT assessing the clinical and personal utility of incorporating type 2 diabetes genetic risk testing into comprehensive diabetes risk assessments performed in a primary care setting. Methods/Design Patients are recruited in the laboratory waiting areas of two primary care clinics and enrolled into one of three study arms. Those interested in genetic risk testing are randomized to receive either a standard risk assessment (SRA for type 2 diabetes incorporating conventional risk factors plus upfront disclosure of the results of genetic risk testing ("SRA+G" arm, or the SRA alone ("SRA" arm. Participants not interested in genetic risk testing will not receive the test, but will receive SRA (forming a third, "no-test" arm. Risk counseling is provided by clinic staff (not study staff external to the clinic. Fasting plasma glucose, insulin levels, body mass index (BMI, and waist circumference are measured at baseline and 12 months, as are patients' self-reported behavioral and emotional responses to diabetes risk information. Primary outcomes are changes in insulin resistance and BMI after 12 months; secondary outcomes include changes in diet patterns, physical activity, waist circumference, and perceived risk of developing diabetes. Discussion The utility, feasibility, and efficacy of providing patients with genetic risk information for common chronic diseases in primary care remain unknown. The study described here will help to establish whether providing type 2 diabetes genetic risk

  9. Randomized placebo controlled blinded study to assess valsartan efficacy in preventing left ventricle remodeling in patients with dual chamber pacemaker--Rationale and design of the trial.

    Science.gov (United States)

    Tomasik, Andrzej; Jacheć, Wojciech; Wojciechowska, Celina; Kawecki, Damian; Białkowska, Beata; Romuk, Ewa; Gabrysiak, Artur; Birkner, Ewa; Kalarus, Zbigniew; Nowalany-Kozielska, Ewa

    2015-05-01

    Dual chamber pacing is known to have detrimental effect on cardiac performance and heart failure occurring eventually is associated with increased mortality. Experimental studies of pacing in dogs have shown contractile dyssynchrony leading to diffuse alterations in extracellular matrix. In parallel, studies on experimental ischemia/reperfusion injury have shown efficacy of valsartan to inhibit activity of matrix metalloproteinase-9, to increase the activity of tissue inhibitor of matrix metalloproteinase-3 and preserve global contractility and left ventricle ejection fraction. To present rationale and design of randomized blinded trial aimed to assess whether 12 month long administration of valsartan will prevent left ventricle remodeling in patients with preserved left ventricle ejection fraction (LVEF ≥ 40%) and first implantation of dual chamber pacemaker. A total of 100 eligible patients will be randomized into three parallel arms: placebo, valsartan 80 mg/daily and valsartan 160 mg/daily added to previously used drugs. The primary endpoint will be assessment of valsartan efficacy to prevent left ventricle remodeling during 12 month follow-up. We assess patients' functional capacity, blood plasma activity of matrix metalloproteinases and their tissue inhibitors, NT-proBNP, tumor necrosis factor alpha, and Troponin T. Left ventricle function and remodeling is assessed echocardiographically: M-mode, B-mode, tissue Doppler imaging. If valsartan proves effective, it will be an attractive measure to improve long term prognosis in aging population and increasing number of pacemaker recipients. ClinicalTrials.org (NCT01805804). Copyright © 2015 Elsevier Inc. All rights reserved.

  10. Rationale, design, and preliminary results of the Quebec Warfarin Cohort Study.

    Science.gov (United States)

    Perreault, Sylvie; Shahabi, Payman; Côté, Robert; Dumas, Stéphanie; Rouleau-Mailloux, Étienne; Feroz Zada, Yassamin; Provost, Sylvie; Mongrain, Ian; Dorais, Marc; Huynh, Thao; Kouz, Simon; Diaz, Ariel; Blostein, Mark; de Denus, Simon; Turgeon, Jacques; Ginsberg, Jeffrey; Lelorier, Jacques; Lalonde, Lyne; Busque, Lambert; Kassis, Jeannine; Talajic, Mario; Tardif, Jean-Claude; Dubé, Marie-Pierre

    2018-05-01

    Over- and undercoagulation with warfarin are associated with hemorrhagic and thromboembolic events, respectively. Genetic and clinical factors affect warfarin response, and the causes of this variability remain unclear. We present descriptive statistics and test for predictors of poor anticoagulation control. The Quebec Warfarin Cohort (QWC) comprises 1059 new warfarin users, with prospective follow-up using telephone questionnaires every 3 months for 1 year, and using healthcare administrative databases (RAMQ and Med-Echo) for 5 years prior to cohort entry and up to 10 years following active patient participation. Genetic material was collected, and genotyping of CYP2C9 and VKORC1 genes was conducted. Measured outcomes included the percentage of time patients spent within therapeutic range, anticoagulation control, warfarin dose, bleeding, and thromboembolic events. We report baseline characteristics and outcomes after 1 year of follow-up. Poor anticoagulation control was defined as time in therapeutic range <60% in the 3- to 12-month interval. Participants had a mean age of 71 years, and 62% were men. The most common indication for warfarin was atrial fibrillation (87%). Mean time in therapeutic range was 56% (±25%) in the 3 months following warfarin initiation, and 70% (±21%) in the 3- to 12-month interval. During follow-up, the rate of stroke or systemic embolism was 1.8 events per 100 person-years; for major bleeding events, 3.3 events per 100 person-years. Independent predictors of poor anticoagulation control were chronic kidney disease, heart failure, dyslipidemia, and age. The QWC represents a good research cohort to investigate clinical and genetic factors in a warfarin-anticoagulated population. © 2018 Wiley Periodicals, Inc.

  11. Skirting around Critical Feminist Rationales for Teaching Women in Social Studies

    Science.gov (United States)

    Schmeichel, Mardi

    2015-01-01

    Feminist practices can provide firm theoretical grounding for the kind of social studies that scholars promote, especially in relation to efforts to include women in the curriculum. However, in P-12 social studies education, neither women nor feminism receive much attention. The study described in this article was a discourse analysis of 16…

  12. The need for precision medicine clinical trials in childhood asthma : rationale and design of the PUFFIN trial

    NARCIS (Netherlands)

    Vijverberg, Susanne J. H.; Pijnenburg, Marielle W.; Hovels, Anke M.; Koppelman, Gerard H.; Maitland-van der Zee, Anke-Hilse

    A `one-size fits all'-approach does not fit all pediatric asthma patients. Current evidence suggests that in children with persistent asthma, ADRB2 genotype-guided treatment can improve treatment outcomes, yet this evidence is mainly derived from observational and genotype-stratified studies.

  13. The need for precision medicine clinical trials in childhood asthma: rationale and design of the PUFFIN trial

    NARCIS (Netherlands)

    Vijverberg, Susanne Jh; Pijnenburg, Mariëlle W.; Hövels, Anke M.; Koppelman, Gerard H.; Maitland-van der Zee, Anke-Hilse

    2017-01-01

    A 'one-size fits all'-approach does not fit all pediatric asthma patients. Current evidence suggests that in children with persistent asthma, ADRB2 genotype-guided treatment can improve treatment outcomes, yet this evidence is mainly derived from observational and genotype-stratified studies.

  14. European Prospective Investigation into Cancer and Nutrition (EPIC) calibration study: rationale, design and population characteristics

    DEFF Research Database (Denmark)

    Slimani, N.; Kaaks, R.; Ferrari, P.

    2002-01-01

    The European Prospective Investigation into Cancer and Nutrition (EPIC), which covers a large cohort of half a million men and women from 23 European centres in 10 Western European countries, was designed to study the relationship between diet and the risk of chronic diseases, particularly cancer......, a calibration approach was developed. This approach involved an additional dietary assessment common across study populations to re-express individual dietary intakes according to the same reference scale. A single 24-hour diet recall was therefore collected, as the EPIC reference calibration method, from...... in a large multi-centre European study. These studies showed that, despite certain inherent methodological and logistic constraints, a study design such as this one works relatively well in practice. The average response in the calibration study was 78.3% and ranged from 46.5% to 92.5%. The calibration...

  15. Learning Environments’ Activity Potential for Preschoolers (LEAPP): Study Rationale and Design

    OpenAIRE

    Tucker, Patricia; Vanderloo, Leigh M.; Newnham-Kanas, Courtney; Burke, Shauna M.; Irwin, Jennifer D.; Johnson, Andrew M.; van Zandvoort, Melissa M.

    2013-01-01

    Background The purpose of this paper is to provide an overview of the study protocol for the Learning Environments’ Activity Potential for Preschoolers (LEAPP) study, the goal of which is to describe the activity levels of preschoolers attending various early learning venues and explore which attributes of these facilities (e.g. curriculum, policies, equipment, etc.) support activity participation. Design and methods This cross-sectional study aimed to recruit approximately 30 early learning ...

  16. Aspirin for the prevention of cognitive decline in the elderly: rationale and design of a neuro-vascular imaging study (ENVIS-ion

    Directory of Open Access Journals (Sweden)

    Reid Christopher M

    2012-02-01

    Full Text Available Abstract Background This paper describes the rationale and design of the ENVIS-ion Study, which aims to determine whether low-dose aspirin reduces the development of white matter hyper-intense (WMH lesions and silent brain infarction (SBI. Additional aims include determining whether a changes in retinal vascular imaging (RVI parameters parallel changes in brain magnetic resonance imaging (MRI; b changes in RVI parameters are observed with aspirin therapy; c baseline cognitive function correlates with MRI and RVI parameters; d changes in cognitive function correlate with changes in brain MRI and RVI and e whether factors such as age, gender or blood pressure influence the above associations. Methods/Design Double-blind, placebo-controlled trial of three years duration set in two Australian academic medical centre outpatient clinics. This study will enrol 600 adults aged 70 years and over with normal cognitive function and without overt cardiovascular disease. Subjects will undergo cognitive testing, brain MRI and RVI at baseline and after 3 years of study treatment. All subjects will be recruited from a 19,000-patient clinical outcome trial conducted in Australia and the United States that will evaluate the effects of aspirin in maintaining disability-free longevity over 5 years. The intervention will be aspirin 100 mg daily versus matching placebo, randomized on a 1:1 basis. Discussion This study will improve understanding of the mechanisms at the level of brain and vascular structure that underlie the effects of aspirin on cognitive function. Given the limited access and high cost of MRI, RVI may prove useful as a tool for the identification of individuals at high risk for the development of cerebrovascular disease and cognitive decline. Trial Registration clinicaltrials.gov Identifier: NCT01038583

  17. Readiness for diabetes prevention and barriers to lifestyle change in women with a history of gestational diabetes mellitus: rationale and study design.

    Science.gov (United States)

    Lipscombe, Lorraine L; Banerjee, Ananya Tina; McTavish, Sarah; Mukerji, Geetha; Lowe, Julia; Ray, Joel; Evans, Marilyn; Feig, Denice S

    2014-10-01

    Women with gestational diabetes mellitus (GDM) have a high risk of future diabetes, which can be prevented with lifestyle modification. Prior diabetes prevention programmes in this population have been limited by lack of adherence. The aim of this study is to evaluate readiness for behaviour change at different time points after GDM diagnosis and identify barriers and facilitators, to inform a lifestyle modification programme specifically designed for this group. The objective of this paper is to present the rationale and methodological design of this study. The ongoing prospective cohort study has recruited a multi-ethnic cohort of 1353 women with GDM from 7 Ontario, Canada hospitals during their pregnancy. A questionnaire was developed to evaluate stage of readiness for behaviour change, and sociodemographic, psychosocial, and clinical predictors of healthy diet and physical activity. Thus far, 960 women (71%) have completed a baseline survey prior to delivery. Prospective postpartum follow-up is ongoing. We are surveying women at 2 time-points after delivery: 3-12 months postpartum, and 13-24 months postpartum. Survey data will be linked to health care administrative databases for long-term follow-up for diabetes. Qualitative interviews were conducted in a subset of women to gain a deeper understanding of barriers and facilitators to lifestyle change. Our study is a fundamental first step in effectively addressing diabetes prevention in women with GDM. Our findings will aid in the design of a diabetes prevention intervention specifically targeted to women with recent GDM, which can then be evaluated in a clinical trial. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  18. The Netherlands Study of Depression and Anxiety (NESDA): rationale, objectives and methods.

    NARCIS (Netherlands)

    Penninx, B.W.J.H.; Beekman, A.T.F.; Smit, J.H.; Zitman, F.G.; Nolen, W.A.; Spinhoven, P.; Cuijpers, P.; Jong, P.J. de; Marwijk, H.W.J. van; Assendelft, W.J.J.; Meer, K. van der; Verhaak, P.; Wensing, M.; Graaf, R. de; Hoogendijk, W.J.; Ormel, J.; Dyck, R. van

    2008-01-01

    The Netherlands Study of Depression and Anxiety (NESDA) is a multi-site naturalistic cohort study to: (1) describe the long-term course and consequences of depressive and anxiety disorders, and (2) to integrate biological and psychosocial research paradigms within an epidemiological approach in

  19. The Alberta Pregnancy Outcomes and Nutrition (APrON) cohort study : rationale and methods

    NARCIS (Netherlands)

    Kaplan, Bonnie J.; Giesbrecht, Gerald F.; Leung, Brenda M. Y.; Field, Catherine J.; Dewey, Deborah; Bell, Rhonda C.; Manca, Donna P.; O'Beirne, Maeve; Johnston, David W.; Pop, Victor J.; Singhal, Nalini; Gagnon, Lisa; Bernier, Francois P.; Eliasziw, Misha; McCargar, Linda J.; Kooistra, Libbe; Farmer, Anna; Cantell, Marja; Goonewardene, Laki; Casey, Linda M.; Letourneau, Nicole; Martin, Jonathan W.

    The Alberta Pregnancy Outcomes and Nutrition (APrON) study is an ongoing prospective cohort study that recruits pregnant women early in pregnancy and, as of 2012, is following up their infants to 3 years of age. It has currently enrolled approximately 5000 Canadians (2000 pregnant women, their

  20. The Alberta Pregnancy Outcomes and Nutrition (APrON) cohort study : Rationale and methods

    NARCIS (Netherlands)

    Kaplan, B.J.; Giesbrecht, G.F.; Leung, B.M.; Field, C.J.; Dewey, D.; Bell, R.C.; Manca, D.P.; O'Beirne, M.; Johnston, D.W.; Pop, V.J.M.; Singhal, N.; Gagnon, L.; Bernier, F.P.; Eliasziw, M.; McCargar, L.J.; Kooistra, L.; Farmer, A.; Cantell, M.; Goonewardene, L.; Casey, L.M.; Letourneau, N.; Martin, J.W.

    2014-01-01

    The Alberta Pregnancy Outcomes and Nutrition (APrON) study is an ongoing prospective cohort study that recruits pregnant women early in pregnancy and, as of 2012, is following up their infants to 3 years of age. It has currently enrolled approximately 5000 Canadians (2000 pregnant women, their

  1. Evaluation of a standard provision versus an autonomy promotive exercise referral programme: rationale and study design

    Directory of Open Access Journals (Sweden)

    Jolly Kate

    2009-06-01

    Full Text Available Abstract Background The National Institute of Clinical Excellence in the UK has recommended that the effectiveness of ongoing exercise referral schemes to promote physical activity should be examined in research trials. Recent empirical evidence in health care and physical activity promotion contexts provides a foundation for testing the utility of a Self Determination Theory (SDT-based exercise referral consultation. Methods/Design Design: An exploratory cluster randomised controlled trial comparing standard provision exercise on prescription with a Self Determination Theory-based (SDT exercise on prescription intervention. Participants: 347 people referred to the Birmingham Exercise on Prescription scheme between November 2007 and July 2008. The 13 exercise on prescription sites in Birmingham were randomised to current practice (n = 7 or to the SDT-based intervention (n = 6. Outcomes measured at 3 and 6-months: Minutes of moderate or vigorous physical activity per week assessed using the 7-day Physical Activity Recall; physical health: blood pressure and weight; health status measured using the Dartmouth CO-OP charts; anxiety and depression measured by the Hospital Anxiety and Depression Scale and vitality measured by the subjective vitality score; motivation and processes of change: perceptions of autonomy support from the advisor, satisfaction of the needs for competence, autonomy, and relatedness via physical activity, and motivational regulations for exercise. Discussion This trial will determine whether an exercise referral programme based on Self Determination Theory increases physical activity and other health outcomes compared to a standard programme and will test the underlying SDT-based process model (perceived autonomy support, need satisfaction, motivation regulations, outcomes via structural equation modelling. Trial registration The trial is registered as Current Controlled trials ISRCTN07682833.

  2. BALANOPOSTHITIS: A CLINICAL STUDY

    Directory of Open Access Journals (Sweden)

    Raju

    2015-01-01

    Full Text Available INTRODUCTION: The inflammation of the non - keratinized epithelium of the glans penis (i.e., Balanities and that of prepuce (i.e., posthitis together comprise the term Balanoposthitis. AIMS AND OBJECTIVES: To determine the aetiological and p redisposing factors for the development of Balanoposthitis, and to know its relation with venereal and non - venereal disease, local and systemic precipitatin g factors. To know the prevalence of Balanoposthitis in STD clinic. Study design - retrospective study . MATERIALS AND METHODS: The study material consists of 75 cases of balanoposthitis attending out - patient department Skin & STD clinic during a period exten din g from Feb, 1998 to Feb, 1999 . CRITERIA FOR SELECTION OF A CASE: Only those cases which have a history of redness of glans or mucous surface of prepuce, with or without genital discharge or ulcer on glans or mucosal surface of prepuce with or without discharge or growth on the penis or fissuring of fore skin were selected for the study. RESULTS: Incidence of balanoposthitis during the period from Feb. 98 to Feb.99 was – 11.53%, out of 650 new STD cases. It was observed that maximum number of pat i ents w as in the 21 - 30 age group (33.34%. The next predominant groups affected were 17 - 20 & 31 - 40 age group (20% each. The third most common age group affected was 41 - 50 (16%. In this study 69 patients (92% who presented with balanoposthitis of whatever cause were found to be uncircumcised, only 6 cases (8% were found to be circumcised. Most cases who presented with balanoposthitis gave a history of exposure to STD risk. CONCLUSIONS: Balanoposthitis is very commonly encountered condition in the STD clinics wi th a multi factorial aetiology. Infective causes dominated over the other possible causes, and 30% of the candidial infection had diabetes mellitus as a predisposing factor.

  3. Identification of potential neuromotor mechanisms of manual therapy in patients with musculoskeletal disablement: rationale and description of a clinical trial.

    Science.gov (United States)

    Fisher, Beth E; Davenport, Todd E; Kulig, Kornelia; Wu, Allan D

    2009-05-21

    Many health care practitioners use a variety of hands-on treatments to improve symptoms and disablement in patients with musculoskeletal pathology.Research to date indirectly suggests a potentially broad effect of manual therapy on the neuromotor processing of functional behavior within the supraspinal central nervous system (CNS) in a manner that may be independent of modification at the level of local spinal circuits. However, the effect of treatment speed, as well as the specific mechanism and locus of CNS changes, remain unclear. We developed a placebo-controlled, randomized study to test the hypothesis that manual therapy procedures directed to the talocrural joint in individuals with post-acute ankle sprain induce a change in corticospinal excitability that is relevant to improve the performance of lower extremity functional behavior. This study is designed to identify potential neuromotor changes associated with manual therapy procedures directed to the appendicular skeleton, compare the relative effect of treatment speed on potential neuromotor effects of manual therapy procedures, and determine the behavioral relevance of potential neuromotor effects of manual therapy procedures. http://www.clinicaltrials.gov identifier NCT00847769.

  4. Identification of potential neuromotor mechanisms of manual therapy in patients with musculoskeletal disablement: rationale and description of a clinical trial

    Directory of Open Access Journals (Sweden)

    Kulig Kornelia

    2009-05-01

    Full Text Available Abstract Background Many health care practitioners use a variety of hands-on treatments to improve symptoms and disablement in patients with musculoskeletal pathology. Research to date indirectly suggests a potentially broad effect of manual therapy on the neuromotor processing of functional behavior within the supraspinal central nervous system (CNS in a manner that may be independent of modification at the level of local spinal circuits. However, the effect of treatment speed, as well as the specific mechanism and locus of CNS changes, remain unclear. Methods/Design We developed a placebo-controlled, randomized study to test the hypothesis that manual therapy procedures directed to the talocrural joint in individuals with post-acute ankle sprain induce a change in corticospinal excitability that is relevant to improve the performance of lower extremity functional behavior. Discussion This study is designed to identify potential neuromotor changes associated with manual therapy procedures directed to the appendicular skeleton, compare the relative effect of treatment speed on potential neuromotor effects of manual therapy procedures, and determine the behavioral relevance of potential neuromotor effects of manual therapy procedures. Trial Registration http://www.clinicaltrials.gov identifier NCT00847769.

  5. The Alberta Pregnancy Outcomes and Nutrition (APrON) cohort study: rationale and methods.

    Science.gov (United States)

    Kaplan, Bonnie J; Giesbrecht, Gerald F; Leung, Brenda M Y; Field, Catherine J; Dewey, Deborah; Bell, Rhonda C; Manca, Donna P; O'Beirne, Maeve; Johnston, David W; Pop, Victor J; Singhal, Nalini; Gagnon, Lisa; Bernier, Francois P; Eliasziw, Misha; McCargar, Linda J; Kooistra, Libbe; Farmer, Anna; Cantell, Marja; Goonewardene, Laki; Casey, Linda M; Letourneau, Nicole; Martin, Jonathan W

    2014-01-01

    The Alberta Pregnancy Outcomes and Nutrition (APrON) study is an ongoing prospective cohort study that recruits pregnant women early in pregnancy and, as of 2012, is following up their infants to 3 years of age. It has currently enrolled approximately 5000 Canadians (2000 pregnant women, their offspring and many of their partners). The primary aims of the APrON study were to determine the relationships between maternal nutrient intake and status, before, during and after gestation, and (1) maternal mood; (2) birth and obstetric outcomes; and (3) infant neurodevelopment. We have collected comprehensive maternal nutrition, anthropometric, biological and mental health data at multiple points in the pregnancy and the post-partum period, as well as obstetrical, birth, health and neurodevelopmental outcomes of these pregnancies. The study continues to follow the infants through to 36 months of age. The current report describes the study design and methods, and findings of some pilot work. The APrON study is a significant resource with opportunities for collaboration. © 2012 John Wiley & Sons Ltd.

  6. [Clinical and physiological rationale for use of clonidine with articaine and adrenaline for local anesthesia in pediatric dentistry].

    Science.gov (United States)

    Mel'nikova, A V; Shugaĭlov, I A

    2014-01-01

    The study evaluated the effect of local anesthesia with articaine in different combinations with epinephrine and clonidine (articaine (4%) + epinephrine (1:200 000), articaine (4%) + clonidine (1:100 000), articaine (4%) + epinephrine (1:200 000) + clonidine (1:100 000), articaine (4%) + epinephrine (1:400 000) + clonidine (1:100 000)), on a number of physiological parameters in pediatric dental practice that characterize cardiovascular system, patient's degree of adaptation to a stressful situation and efficacy of analgesia. It is shown that in terms of impact on the cardiovascular system and stress adaptation indicators anesthesia including combination of epinephrine (1: 200 000) and clonidine (1: 100 000) in the anesthetic solution is the safest. Furthermore, this method ensures the most appropriate analgesic effect.

  7. Postnatal Growth and Retinopathy of Prematurity Study: Rationale, Design, and Subject Characteristics.

    Science.gov (United States)

    Binenbaum, Gil; Tomlinson, Lauren A

    2017-02-01

    Postnatal-growth-based predictive models demonstrate strong potential for improving the low specificity of retinopathy of prematurity (ROP) screening. Prior studies are limited by inadequate sample size. We sought to study a sufficiently large cohort of at-risk infants to enable development of a model with highly precise estimates of sensitivity for severe ROP. The Postnatal Growth and ROP (G-ROP) Study was a multicenter retrospective cohort study of infants at 30 North American hospitals during 2006-2012. A total of 65 G-ROP-certified abstractors submitted data to a secure, web-based database. Data included ROP examination findings, treatments, complications, daily weight measurements, daily oxygen supplementation, maternal/infant demographics, medical comorbidities, surgical events, and weekly nutrition. Data quality was monitored with system validation rules, data audits, and discrepancy algorithms. Of 11,261 screened infants, 8334 were enrolled, and 2927 had insufficient data due to transfer, discharge, or death. Of the enrolled infants, 90% (7483) had a known ROP outcome and were included in the study. Median birth weight was 1070 g (range 310-3000g) and mean gestational age 28 weeks (range 22-35 weeks). Severe ROP (Early Treatment of Retinopathy type 1 or 2) developed in 931 infants (12.5%). Successful incorporation of a predictive model into ROP screening requires confidence that it will capture cases of severe ROP. This dataset provides power to estimate sensitivity with half-confidence interval width of less than 0.5%, determined by the high number of severe ROP cases. The G-ROP Study represents a large, diverse cohort of at-risk infants undergoing ROP screening. It will facilitate evaluation of growth-based algorithms to improve efficiency of ROP screening.

  8. Rationale and design of INTERSTROKE: a global case-control study of risk factors for stroke

    DEFF Research Database (Denmark)

    O'Donnell, M; Serpault, Damien Xavier; Diener, C

    2010-01-01

    Stroke is a major global health problem. It is the third leading cause of death and the leading cause of adult disability. INTERHEART, a global case-control study of acute myocardial infarction in 52 countries (29,972 participants), identified nine modifiable risk factors that accounted for >90% ...

  9. Relationship between volition, physical activity and weight loss maintenance: Study rationale, design, methods and baseline characteristics

    DEFF Research Database (Denmark)

    Dandanell, Sune; Elbe, Anne-Marie; Pfister, Gertrud Ursula

    2017-01-01

    ) for an interdisciplinary prospective study with follow-up. The change in lifestyle and weight loss is promoted via a 3-month intensive lifestyle intervention at a private health school. The intervention consists of supervised training (1–3 hours/day), a healthy hypo-caloric diet (−500 to −700 kCal/day) and education...

  10. The Coordination and Activity Tracking in CHildren (CATCH) study: rationale and design.

    Science.gov (United States)

    Cairney, John; Missiuna, Cheryl; Timmons, Brian W; Rodriguez, Christine; Veldhuizen, Scott; King-Dowling, Sara; Wellman, Sarah; Le, Tuyen

    2015-12-21

    Past studies have found that children with Developmental Coordination Disorder (DCD) engage in less physical activity than typically developing children. This "activity deficit" may result in children with DCD being less physically fit and more likely to be overweight or obese, potentially increasing later risk for poor cardiovascular health. Unfortunately, the majority of DCD research has been limited to cross-sectional designs, leading to questions about the complex relationship among motor ability, inactivity and health-related fitness. Of the few longitudinal studies on the topic, determining precedence amongst these factors is difficult because study cohorts typically focus on mid to late childhood. By this age, both decreased physical fitness and obesity are often established. The Coordination and Activity Tracking in CHildren (CATCH) study will examine the pathways connecting DCD, physical activity, physical fitness, and body composition from early to middle childhood. The CATCH study is a prospective cohort study. We aim to recruit a cohort of 600 children aged 4 to 5 years (300 probable DCD [pDCD] and 300 controls) and test them once a year for 4 years. At Phase 1 of baseline testing, we assess motor skills, cognitive ability (IQ), basic anthropometry, flexibility and lower body muscle strength, while parents complete an interview and questionnaires regarding family demographics, their child's physical activity, and behavioural characteristics. Children who move on to Phase 2 (longitudinal cohort) have their body fat percentage, foot structure, aerobic and anaerobic fitness assessed. An accelerometer to measure physical activity is then given to the child and interested family members. The family also receives an accelerometer logbook and 3-day food dairy. At years 2 to 4, children in the longitudinal cohort will have all baseline assessments repeated (excluding the IQ test), and complete an additional measure of perceived self-efficacy. Parents will

  11. Air pollution and cardiovascular and respiratory disease: Rationale and methodology of CAPACITY study

    Science.gov (United States)

    Rabiei, Katayoun; Hosseini, Sayed Mohsen; Sadeghi, Erfan; Jafari-Koshki, Tohid; Rahimi, Mojtaba; Shishehforoush, Mansour; Lahijanzadeh, Ahmadreza; Sadeghian, Babak; Moazam, Elham; Mohebi, Mohammad Bagher; Ezatian, Victoria; Sarrafzadegan, Nizal

    2017-01-01

    BACKGROUND Considering the high level of air pollution and its impact on health, we aimed to study the correlation of air pollution with hospitalization and mortality of cardiovascular (CVD) and respiratory diseases (ResD) (CAPACITY) to determine the effects of air pollutants on CVD and ResD hospitalizations and deaths in Isfahan, Iran. METHODS Hourly levels of air pollutants including particulate matter (PM), carbon monoxide (CO), nitrogen dioxide (NO2), sulfur dioxide (SO2), and ozone (O3), information of CVD and ResD admissions and death certificate were obtained respectively from Department of Environment (DOE), Iran, hospitals and cemetery. Time series and case-crossover model were used to find the impact of air pollutants. This paper only summarizes the descriptive findings of the CAPACITY study. RESULTS The total number of hospitalized patients were 23781 in 2010 and 22485 in 2011. The most frequent cause of hospitalization and death was ischemic heart diseases in both years. While the mean annual levels of O3, CO, and PM10 were lower in 2011 than in 2010, NO2 and SO2 levels higher in 2011. In both years, PM10 was similarly increased during last month of fall, late spring and early summer. In 2011, the PM2.5 and PM10 monthly trend of change were similar. CONCLUSION The CAPACITY study is one of the few large-scale studies that evaluated the effects of air pollutants on a variety of CVD and ResD in a large city of Iran. This study can provide many findings that could clarify the effects of these pollutants on the incidence and burden of both disease groups. PMID:29643921

  12. Air pollution and cardiovascular and respiratory disease: Rationale and methodology of CAPACITY study.

    Science.gov (United States)

    Rabiei, Katayoun; Hosseini, Sayed Mohsen; Sadeghi, Erfan; Jafari-Koshki, Tohid; Rahimi, Mojtaba; Shishehforoush, Mansour; Lahijanzadeh, Ahmadreza; Sadeghian, Babak; Moazam, Elham; Mohebi, Mohammad Bagher; Ezatian, Victoria; Sarrafzadegan, Nizal

    2017-11-01

    Considering the high level of air pollution and its impact on health, we aimed to study the correlation of air pollution with hospitalization and mortality of cardiovascular (CVD) and respiratory diseases (ResD) (CAPACITY) to determine the effects of air pollutants on CVD and ResD hospitalizations and deaths in Isfahan, Iran. Hourly levels of air pollutants including particulate matter (PM), carbon monoxide (CO), nitrogen dioxide (NO2), sulfur dioxide (SO2), and ozone (O3), information of CVD and ResD admissions and death certificate were obtained respectively from Department of Environment (DOE), Iran, hospitals and cemetery. Time series and case-crossover model were used to find the impact of air pollutants. This paper only summarizes the descriptive findings of the CAPACITY study. The total number of hospitalized patients were 23781 in 2010 and 22485 in 2011. The most frequent cause of hospitalization and death was ischemic heart diseases in both years. While the mean annual levels of O3, CO, and PM10 were lower in 2011 than in 2010, NO2 and SO2 levels higher in 2011. In both years, PM10 was similarly increased during last month of fall, late spring and early summer. In 2011, the PM2.5 and PM10 monthly trend of change were similar. The CAPACITY study is one of the few large-scale studies that evaluated the effects of air pollutants on a variety of CVD and ResD in a large city of Iran. This study can provide many findings that could clarify the effects of these pollutants on the incidence and burden of both disease groups.

  13. Air pollution and cardiovascular and respiratory disease: Rationale and methodology of CAPACITY study

    Directory of Open Access Journals (Sweden)

    Katayoun Rabiei

    2017-11-01

    Full Text Available BACKGROUND: Considering the high level of air pollution and its impact on health, we aimed to study the correlation of air pollution with hospitalization and mortality of cardiovascular (CVD and respiratory diseases (ResD (CAPACITY to determine the effects of air pollutants on CVD and ResD hospitalizations and deaths in Isfahan, Iran.METHODS: Hourly levels of air pollutants including particulate matter (PM, carbon monoxide (CO, nitrogen dioxide (NO2, sulfur dioxide (SO2, and ozone (O3, information of CVD and ResD admissions and death certificate were obtained respectively from Department of Environment (DOE, Iran, hospitals and cemetery. Time series and case-crossover model were used to find the impact of air pollutants. This paper only summarizes the descriptive findings of the CAPACITY study.RESULTS: The total number of hospitalized patients were 23781 in 2010 and 22485 in 2011. The most frequent cause of hospitalization and death was ischemic heart diseases in both years. While the mean annual levels of O3, CO, and PM10 were lower in 2011 than in 2010, NO2 and SO2 levels higher in 2011. In both years, PM10 was similarly increased during last month of fall, late spring and early summer. In 2011, the PM2.5 and PM10 monthly trend of change were similar.CONCLUSION: The CAPACITY study is one of the few large-scale studies that evaluated the effects of air pollutants on a variety of CVD and ResD in a large city of Iran. This study can provide many findings that could clarify the effects of these pollutants on the incidence and burden of both disease groups. 

  14. Rationale and design of INTERSTROKE: a global case-control study of risk factors for stroke

    DEFF Research Database (Denmark)

    O'Donnell, M; Serpault, Damien Xavier; Diener, C

    2010-01-01

    with a first stroke within 72 h of hospital presentation in whom CT or MRI is performed. Proxy respondents are used for cases unable to communicate. Etiological and topographical stroke subtype is documented for all cases. Controls are hospital- and community-based, matched for gender, ethnicity and age (+/-5...... years). A questionnaire (cases and controls) is used to acquire information on known and proposed risk factors for stroke. Cardiovascular (e.g. blood pressure) and anthropometric (e.g. waist-to-hip ratio) measurements are obtained at the time of interview. Nonfasting blood samples and random urine......-income countries is inadequate, where a very large burden of stroke occurs. Accordingly, a similar epidemiological study is required for stroke, to inform effective population-based strategies to reduce the risk of stroke. Methods: INTERSTROKE is an international, multicenter case-control study. Cases are patients...

  15. Environment and Health in Children Day Care Centres (ENVIRH) - Study rationale and protocol.

    Science.gov (United States)

    Araújo-Martins, J; Carreiro Martins, P; Viegas, J; Aelenei, D; Cano, M M; Teixeira, J P; Paixão, P; Papoila, A L; Leiria-Pinto, P; Pedro, C; Rosado-Pinto, J; Annesi-Maesano, I; Neuparth, N

    2014-01-01

    Indoor air quality (IAQ) is considered an important determinant of human health. The association between exposure to volatile organic compounds, particulate matter, house dust mite, molds and bacteria in day care centers (DCC) is not completely clear. The aim of this project was to study these effects. This study comprised two phases. Phase I included an evaluation of 45 DCCs (25 from Lisbon and 20 from Oporto, targeting 5161 children). In this phase, building characteristics, indoor CO2 and air temperature/relative humidity, were assessed. A children's respiratory health questionnaire derived from the ISAAC (International Study on Asthma and Allergies in Children) was also distributed. Phase II encompassed two evaluations and included 20 DCCs selected from phase I after a cluster analysis (11 from Lisbon and 9 from Oporto, targeting 2287 children). In this phase, data on ventilation, IAQ, thermal comfort parameters, respiratory and allergic health, airway inflammation biomarkers, respiratory virus infection patterns and parental and child stress were collected. In Phase I, building characteristics, occupant behavior and ventilation surrogates were collected from all DCCs. The response rate of the questionnaire was 61.7% (3186 children). Phase II included 1221 children. Association results between DCC characteristics, IAQ and health outcomes will be provided in order to support recommendations on IAQ and children's health. A building ventilation model will also be developed. This paper outlines methods that might be implemented by other investigators conducting studies on the association between respiratory health and indoor air quality at DCC. Copyright © 2013 Sociedade Portuguesa de Pneumologia. Published by Elsevier España. All rights reserved.

  16. Rationale and methods for an epidemiologic study of cancer among Seventh-Day Adventists.

    Science.gov (United States)

    Phillips, R L; Kuzma, J W

    1977-12-01

    Considerable evidence was found that Adventists are a low-risk population to develop cancer of many sites. Adventists have numerous unique life-style and dietary habits with great variability within the population in adherence to these practices as well as considerable variation in duration of exposure to these characteristics. Thus this study population will likely be extremely productive in identifying dietary habits or other life-style characteristics that are etiologically related to various cancer sites.

  17. Rationale, design and methods of the HEALTHY study nutrition intervention component.

    Science.gov (United States)

    Gillis, B; Mobley, C; Stadler, D D; Hartstein, J; Virus, A; Volpe, S L; El ghormli, L; Staten, M A; Bridgman, J; McCormick, S

    2009-08-01

    The HEALTHY study was a randomized, controlled, multicenter and middle school-based, multifaceted intervention designed to reduce risk factors for the development of type 2 diabetes. The study randomized 42 middle schools to intervention or control, and followed students from the sixth to the eighth grades. Here we describe the design of the HEALTHY nutrition intervention component that was developed to modify the total school food environment, defined to include the following: federal breakfast, lunch, after school snack and supper programs; a la carte venues, including snack bars and school stores; vending machines; fundraisers; and classroom parties and celebrations. Study staff implemented the intervention using core and toolbox strategies to achieve and maintain the following five intervention goals: (1) lower the average fat content of foods, (2) increase the availability and variety of fruits and vegetables, (3) limit the portion sizes and energy content of dessert and snack foods, (4) eliminate whole and 2% milk and all added sugar beverages, with the exception of low fat or nonfat flavored milk, and limit 100% fruit juice to breakfast in small portions and (5) increase the availability of higher fiber grain-based foods and legumes. Other nutrition intervention component elements were taste tests, cafeteria enhancements, cafeteria line messages and other messages about healthy eating, cafeteria learning laboratory (CLL) activities, twice-yearly training of food service staff, weekly meetings with food service managers, incentives for food service departments, and twice yearly local meetings and three national summits with district food service directors. Strengths of the intervention design were the integration of nutrition with the other HEALTHY intervention components (physical education, behavior change and communications), and the collaboration and rapport between the nutrition intervention study staff members and food service personnel at both school

  18. A human dietary arachidonic acid supplementation study conducted in a metabolic research unit: rationale and design.

    Science.gov (United States)

    Nelson, G J; Kelley, D S; Emken, E A; Phinney, S D; Kyle, D; Ferretti, A

    1997-04-01

    While there are many reports of studies that fed arachidonic acid (AA) to animals, there are very few reports of AA feeding to humans under controlled conditions. This 130-d study was conceived as a controlled, symmetrical crossover design with healthy, adult male volunteers. They lived in the metabolic research unit (MRU) of the Western Human Nutrition Research (WHNRC) for the entire study. All food was prepared by the WHNRC kitchen. The basal (low-AA) diet consisted of natural foods (30 en% fat, 15 en% protein, and 55 en% carbohydrate), containing 210 mg/d of AA, and met the recommended daily allowance for all nutrients. The high-AA (intervention) diet was similar except that 1.5 g/d of AA in the form of a triglyceride containing 50% AA replaced an equal amount of high-oleic safflower oil in the basal diet. The subjects (ages 20 to 39) were within -10 to +20% of ideal body weight, nonsmoking, and not allowed alcohol in the MRU. Their exercise level was constant, and their body weights were maintained within 2% of entry level. Subjects were initially fed the low-AA diet for 15 d. On day 16, half of the subjects (group A) wee placed on the high-AA diet, and the other group (B) remained on the low-AA diets. On day 65, the two groups switched diets. On day 115, group B returned to the low-AA diet. This design, assuming no carryover effect, allowed us to merge the data from the two groups, with the data comparison days being 65 (low-AA) and 115 (high-AA) for group B and 130 (low-AA) and 65 (high-AA) for group A. The main indices studied were the fatty acid composition of the plasma, red blood cells, platelets, and adipose tissue; in vitro platelet aggregation, bleeding times, clotting factors; immune response as measured by delayed hypersensitivity skin tests, cellular proliferation of peripheral blood mononuclear cells in response to various mitogens and antigens, natural killer cell activity, and response to measles/mumps/rubella and influenza vaccines; the

  19. Comparing the effect of hydroxyethyl starch 130/0.4 with balanced crystalloid solution on mortality and kidney failure in patients with severe sepsis (6S - Scandinavian Starch for Severe Sepsis/Septic Shock trial): Study protocol, design and rationale for a double-blinded, randomised clinical trial

    DEFF Research Database (Denmark)

    Perner, Anders; Haase, Nicolai; Wetterslev, Jørn

    2011-01-01

    ABSTRACT: BACKGROUND: By tradition colloid solutions have been used to obtain fast circulatory stabilisation in shock, but high molecular weight hydroxyethyl starch (HES) may cause acute kidney failure in patients with severe sepsis. Now lower molecular weight HES 130/0.4 is the preferred colloid...... of HES 130/0.4 in patients with severe sepsis. The effects on mortality, dialysis-dependency, time on ventilator, bleeding and markers of resuscitation, metabolism, kidney failure, and coagulation will be assessed. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00962156....

  20. The Rationale for Comparative Effectiveness of Tourist Potential Realization (Case Study of the Volga Region

    Directory of Open Access Journals (Sweden)

    Anna Nikolaevna Polukhina

    2016-11-01

    Full Text Available The article presents the analysis of long-term tourism development programs of the Volga Region. Great attention is given to the sector’s financing measures set out in development programs. Domestic and foreign tourist potential assessment methods are analyzed. Tourist potential dynamics of the Volga Region is studied based on expert opinion. Using econometric approach the authors study the correlation between tourism investments and incomes of the Volga Region for the past six years – from 2009 to 2014. The analysis was carried out using statistics provided by the Russian Tourism Association and the Federal State Statistics Service of the Russian Federation by category of profitability from paid tourist services and from hospitality and catering services. The conducted analysis helped construct the figures showing the differentiation of the Volga regions by tourism investment efficiency and tourist potential realization. It is shown that tourist potential of the territories and its realization are highly differentiated. The sub-regions of the Volga Region are divided into groups according to the effectiveness of potential realization. The effectiveness of implementation of natural recreational and historical and cultural potential is higher in the sub-regions where places of tourist accommodation and entertainment are developed enough, effective mechanisms for programs implementation control are formed and the indicators of expected effectiveness of measures implementation are elaborated. The study has revealed the need for the development of common indicators of expected final results of tourism development programs. The use of a unified system of standardized indicators should become the principle of monitoring the implementation of regional tourism development programs. Data obtained by the research will be useful for the improvement of the existing regional tourism development programs

  1. The Biomarkers of Exposure and Effect in Agriculture (BEEA) Study: Rationale, Design, Methods, and Participant Characteristics.

    Science.gov (United States)

    Hofmann, Jonathan N; Beane Freeman, Laura E; Lynch, Charles F; Andreotti, Gabriella; Thomas, Kent W; Sandler, Dale P; Savage, Sharon A; Alavanja, Michael C

    2015-01-01

    Agricultural exposures including pesticides, endotoxin, and allergens have been associated with risk of various cancers and other chronic diseases, although the biological mechanisms underlying these associations are generally unclear. To facilitate future molecular epidemiologic investigations, in 2010 the study of Biomarkers of Exposure and Effect in Agriculture (BEEA) was initiated within the Agricultural Health Study, a large prospective cohort in Iowa and North Carolina. Here the design and methodology of BEEA are described and preliminary frequencies for participant characteristics and current agricultural exposures are reported. At least 1,600 male farmers over 50 years of age will be enrolled in the BEEA study. During a home visit, participants are asked to complete a detailed interview about recent agricultural exposures and provide samples of blood, urine, and (since 2013) house dust. As of mid-September 2014, in total, 1,233 participants have enrolled. Most of these participants (83%) were still farming at the time of interview. Among those still farming, the most commonly reported crops were corn (81%) and soybeans (74%), and the most frequently noted animals were beef cattle (35%) and hogs (13%). There were 861 (70%) participants who reported occupational pesticide use in the 12 months prior to interview; among these participants, the most frequently noted herbicides were glyphosate (83%) and 2,4-D (72%), and most commonly reported insecticides were malathion (21%), cyfluthrin (13%), and permethrin (12%). Molecular epidemiologic investigations within BEEA have the potential to yield important new insights into the biological mechanisms through which these or other agricultural exposures influence disease risk.

  2. Children, parents, and pets exercising together (CPET randomised controlled trial: study rationale, design, and methods

    Directory of Open Access Journals (Sweden)

    Yam Philippa S

    2012-03-01

    Full Text Available Abstract Background Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. Methods/design The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry; body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. Discussion The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical

  3. Children, parents, and pets exercising together (CPET) randomised controlled trial: study rationale, design, and methods.

    Science.gov (United States)

    Yam, Philippa S; Morrison, Ryan; Penpraze, Viki; Westgarth, Carri; Ward, Dianne S; Mutrie, Nanette; Hutchison, Pippa; Young, David; Reilly, John J

    2012-03-19

    Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry); body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical activity promotion in families. It should advance our

  4. Nature of Science Progression in School Year 1-9: a Case Study of Teachers' Suggestions and Rationales

    Science.gov (United States)

    Leden, Lotta; Hansson, Lena

    2017-07-01

    The inclusion of nature of science (NOS) in science education has for a long time been regarded as crucial. There is, however, a lack of research on appropriate NOS aspects for different educational levels. An even more neglected area of research is that focusing on teachers' perspectives on NOS teaching at different levels. The aim of this article is to examine NOS progression in the light of teachers' suggestions and rationales. In order to obtain teachers' informed perspectives, we chose to involve six teachers (teaching grades 1-9) in a 3-year research project. They took part in focus group discussions about NOS and NOS teaching as well as implemented jointly planned NOS teaching sessions. Data that this article builds on was collected at the end of the project. The teachers' suggestions for NOS progression often relied on adding more NOS issues at every stage, thereby creating the foundations of a broader but not necessarily deeper understanding of NOS. Five rationales, for if/when specific NOS issues are appropriate to introduce, emerged from the analysis of the teacher discussions. Some of these rationales, including practice makes perfect and increasing levels of depth can potentially accommodate room for many NOS issues in the science classroom, while maturity and experience instead has a restricting effect on NOS teaching. Also, choice of context and teaching approaches play an important role in teachers' rationales for whether specific NOS issues should be included or not at different stages. The article discusses the implications for teacher education and professional development.

  5. Rationale and design of South Asian Birth Cohort (START: a Canada-India collaborative study

    Directory of Open Access Journals (Sweden)

    Anand Sonia S

    2013-01-01

    Full Text Available Abstract Background People who originate from the Indian subcontinent (South Asians suffer among the highest rates of type 2 diabetes in the world. Prior evidence suggests that metabolic risk factors develop early in life and are influenced by maternal and paternal behaviors, the intrauterine environment, and genetic factors. The South Asian Birth Cohort Study (START will investigate the environmental and genetic basis of adiposity among 750 South Asian offspring recruited from highly divergent environments, namely, rural and urban India and urban Canada. Methods Detailed information on health behaviors including diet and physical activity, and blood samples for metabolic parameters and DNA are collected from pregnant women of South Asian ancestry who are free of significant chronic disease. They also undergo a provocative test to diagnose impaired glucose tolerance and gestational diabetes. At delivery, cord blood and newborn anthropometric indices (i.e. birth weight, length, head circumference and skin fold thickness are collected. The mother and growing offspring are followed prospectively and information on the growth trajectory, adiposity and health behaviors will be collected annually up to age 3 years. Our aim is to recruit a minimum of 750 mother-infant pairs equally divided between three divergent environments: rural India, urban India, and Canada. Summary The START cohort will increase our understanding of the environmental and genetic determinants of adiposity and related metabolic abnormalities among South Asians living in India and Canada.

  6. Canadian Alliance for Healthy Hearts and Minds: First Nations Cohort Study Rationale and Design.

    Science.gov (United States)

    Anand, Sonia S; Abonyi, Sylvia; Arbour, Laura; Brook, Jeff; Bruce, Sharon; Castleden, Heather; Desai, Dipika; de Souza, Russell J; Harris, Stewart; Irvine, James; Lai, Christopher; Lewis, Diana; Oster, Richard T; Poirier, Paul; Toth, Ellen L; Bannon, Karen; Chrisjohn, Vicky; Davis, Albertha D; L'Hommecourt, Jean; Littlechild, Randy; McMullin, Kathleen; McIntosh, Sarah; Morrison, Julie; Picard, Manon; Landing First Nation, Pictou; M Thomas, Melissa; Tusevljak, Natasa; Friedrich, Matthias G; Tu, Jack V

    2018-01-01

    This is the first national indigenous cohort study in which a common, in-depth protocol with a common set of objectives has been adopted by several indigenous communities across Canada. The overarching objective of the Canadian Alliance for Healthy Hearts and Minds (CAHHM) cohort is to investigate how the community-level environment is associated with individual health behaviors and the presence and progression of chronic disease risk factors and chronic diseases such as cardiovascular disease (CVD) and cancer. CAHHM aims to recruit approximately 2,000 First Nations indigenous individuals from up to nine communities across Canada and have participants complete questionnaires, blood collection, physical measurements, cognitive assessments, and magnetic resonance imaging (MRI). Through individual- and community-level data collection, we will develop an understanding of the specific role of the socioenvironmental, biological, and contextual factors have on the development of chronic disease risk factors and chronic diseases. Information collected in the indigenous cohort will be used to assist communities to develop local management strategies for chronic disease, and can be used collectively to understand the contextual, environmental, socioeconomic, and biological determinants of differences in health status in harmony with First Nations beliefs and reality.

  7. Alpha-hydroxyacid chemical peeling agents: case studies and rationale for safe and effective use.

    Science.gov (United States)

    Briden, M Elizabeth

    2004-02-01

    Chemical peeling is an in-office procedure that involves the application of a chemical agent to the skin to induce controlled destruction or exfoliation of old skin and stimulation of new epidermal growth with more evenly distributed melanin. When peel agents reach the dermal layer, important wound-healing activities occur that cause skin remodeling and skin smoothing, both antiaging benefits. There are a number of key factors in selecting a peeling agent and procedure, and each is discussed. Variables to consider are the peeling agent and its formulation, the concentration of the agent, the patient's skin type, the site to be peeled, the skin preparation procedure prior to and immediately preceding the application of the agent, the application method, the duration of contact, and the patient's medical history and lifestyle. Various types of peels are discussed. Of particular interest are superficial chemical peels, which offer great flexibility over a range of skin types and conditions with minimal to no "downtime." Alpha-hydroxyacid (AHA) peels are superficial and can be combined with other cosmetic procedures in the office to maximize benefits. In addition, AHA peels work well when combined with supportive homecare products including AHAs or polyhydroxy acids (PHAs), topical retinoids, and antiacne/antirosacea treatments. Case studies are presented of patients using AHA peels for the treatment of acne and hyperpigmentation in a variety of skin types, including Asian skin.

  8. Study design, objectives, hypotheses, main findings, health consequences for the population exposed, rationale of future research

    Energy Technology Data Exchange (ETDEWEB)

    Trnovec, T.; Kocan, A. [Slovak Medical Univ., Bratislava (Slovakia); Bencko, V. [Charles Univ., Prague (Czech Republic); Langer, P. [Institute of Experimental Endocrinology SAS, Bratislava (Slovakia); Berg, M. van den [Rijksuniversiteit Utrecht (Netherlands); Bergman, A. [Stockholm Univ. (Sweden); Hustak, M. [Air Force Military Hospital, Kosics (Slovakia)

    2004-09-15

    In Slovakia, the Chemko Chemical Company, based in Strazske, in the Michalovce district, produced PCBs between 1959 and 1984, in the amount of more than 21,000 tons of commercial mixtures (Delor 103, 104, 105, 106, Delotherm DK and DH, Hydelor 137). PCBs were used for similar industrial purposes as in the west. Improper disposal from the Chemko plant via release of effluent directly into the Laborec River resulted in long-term contamination of sediment. As a result eastern Slovakia, the Michalovce district in particular, is recognized as one of the areas all over the world most heavily polluted with PCBs. Historical studies show that blood and adipose PCB levels were higher in Czechoslovakia than elsewhere in the 1970's and 1980's. Current data indicate that persons who eat locally raised food - pork, beef, poultry, eggs - in this district have elevated serum concentrations of PCBs. Environmental exposure to organochlorines in the Michalovce district indicate association with higher rates of certain cancers, but an inverse association with risk of breast cancer. An increased prevalence of thyroid disorders in the polluted area was also reported. This ''experimental setting in nature'' has attracted international scientific teams and two projects in the area are ongoing: Evaluating Human Health Risk from Low-dose and Long-term PCB Exposure, 5{sup th} FP Project QLK4-2000-00488, 2001- 2004; PCBRISK (http://www.pcbrisk.sk/) and Early Childhood Development and PCB Exposures in Slovakia, NCI/NIH, R01-CA96525 University of California, Davis, USA. This paper is serving as an introduction to papers of a session reporting on various health outcomes associated with PCB exposure. The objectives of the PCBRISK project were targeted at an evaluation of the human health risks of low-dose and long-term exposure to a group of persistent organochlorine pollutants, including polychlorinated biphenyls (PCBs) and their metabolites, organochlorine

  9. Security controls in an integrated Biobank to protect privacy in data sharing: rationale and study design.

    Science.gov (United States)

    Takai-Igarashi, Takako; Kinoshita, Kengo; Nagasaki, Masao; Ogishima, Soichi; Nakamura, Naoki; Nagase, Sachiko; Nagaie, Satoshi; Saito, Tomo; Nagami, Fuji; Minegishi, Naoko; Suzuki, Yoichi; Suzuki, Kichiya; Hashizume, Hiroaki; Kuriyama, Shinichi; Hozawa, Atsushi; Yaegashi, Nobuo; Kure, Shigeo; Tamiya, Gen; Kawaguchi, Yoshio; Tanaka, Hiroshi; Yamamoto, Masayuki

    2017-07-06

    With the goal of realizing genome-based personalized healthcare, we have developed a biobank that integrates personal health, genome, and omics data along with biospecimens donated by volunteers of 150,000. Such a large-scale of data integration involves obvious risks of privacy violation. The research use of personal genome and health information is a topic of global discussion with regard to the protection of privacy while promoting scientific advancement. The present paper reports on our plans, current attempts, and accomplishments in addressing security problems involved in data sharing to ensure donor privacy while promoting scientific advancement. Biospecimens and data have been collected in prospective cohort studies with the comprehensive agreement. The sample size of 150,000 participants was required for multiple researches including genome-wide screening of gene by environment interactions, haplotype phasing, and parametric linkage analysis. We established the T ohoku M edical M egabank (TMM) data sharing policy: a privacy protection rule that requires physical, personnel, and technological safeguards against privacy violation regarding the use and sharing of data. The proposed policy refers to that of NCBI and that of the Sanger Institute. The proposed policy classifies shared data according to the strength of re-identification risks. Local committees organized by TMM evaluate re-identification risk and assign a security category to a dataset. Every dataset is stored in an assigned segment of a supercomputer in accordance with its security category. A security manager should be designated to handle all security problems at individual data use locations. The proposed policy requires closed networks and IP-VPN remote connections. The mission of the biobank is to distribute biological resources most productively. This mission motivated us to collect biospecimens and health data and simultaneously analyze genome/omics data in-house. The biobank also has the

  10. Small sustainable monetary incentives versus charitable donations to promote exercise: Rationale, design, and baseline data from a randomized pilot study.

    Science.gov (United States)

    Williams, David M; Lee, Harold H; Connell, Lauren; Boyle, Holly; Emerson, Jessica; Strohacker, Kelley; Galárraga, Omar

    2018-03-01

    Regular physical activity (PA) enhances weight-loss and reduces risk of chronic disease. However, as few as 10% of U.S. adults engage in regular PA. Incentive programs to promote PA have shown some promise, but have typically used incentives that are too large to sustain over time and have not demonstrated habit formation or been tested in community settings. This report presents the rationale and design of a randomized pilot study testing the feasibility and preliminary efficacy of small monetary incentives for PA (n=25) versus charitable donations in the same amount (n=25) versus control (n=25) over 12months among 75 low-active but otherwise healthy adults at a local YMCA. Incentives are based on YMCA attendance, which is verified by electronic swipe card data and is the primary study outcome, with self-reported minutes/week of PA assessed as a secondary outcome. Incentives are intentionally small enough-$1/session, maximum of $5/week-such that they could be indefinitely sustained by community organizations, privately-owned health clubs, healthcare organizations, or employers (e.g., employer fitness facilities). Costs of the incentive program for the sponsoring organization may be partially offset by increases in membership resulting from the appeal of the program. Moreover, if efficacious, the charitable donation incentive program may have the added benefit of building social capital for the sponsoring organization and potentially serving as a tax write-off, thus further offsetting the cost of the incentives. Findings will also have implications for the use of financially sustainable community-based incentive programs for other health-related behaviors (e.g., weight loss, smoking). Copyright © 2018 Elsevier Inc. All rights reserved.

  11. Randomized controlled trial to evaluate the effect of canola oil on blood vessel function in peripheral arterial disease: rationale and design of the Canola-PAD Study

    Directory of Open Access Journals (Sweden)

    Enns JE

    2014-10-01

    Full Text Available Jennifer E Enns,1,2 Peter Zahradka,1–3 Randolph P Guzman,4,5 Alanna Baldwin,1 Brendon Foot,1 Carla G Taylor1–31Canadian Centre for Agri-Food Research in Health and Medicine, St Boniface Research Centre, Winnipeg, Canada; 2Department of Physiology, University of Manitoba, Winnipeg, Manitoba, Canada; 3Department of Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada; 4IH Asper Clinical Research Institute, St Boniface Hospital, Winnipeg, Canada; 5Section of Vascular Surgery, Department of Surgery, St Boniface Hospital, Winnipeg, CanadaBackground: Individuals with peripheral arterial disease (PAD are at high risk for cardiac events due to atherosclerosis. Dietary fatty acid composition has been shown to modulate blood vessel properties, but whether a diet enriched in conventional canola oil can improve clinical endpoints in PAD is not known.Purpose: To describe the rationale and design of a clinical trial testing the effect of canola oil consumption on vascular function and cardiovascular risk factors in an 8-week dietary intervention in individuals with PAD.Methods: The Canola-PAD Study was a single center, prospective, double-blind, randomized controlled trial in 50 patients over 40 years old with PAD. Participants were randomized into two groups and consumed food items containing either conventional canola oil (25 g/day or an oil mixture representing the Western diet (25 g/day for 8 weeks as part of their usual diet. The primary outcome was vascular function (ankle-brachial index, arterial stiffness, endothelial dysfunction, walking capacity, and cognitive function. Secondary measurements included anthropometrics, serum lipid profile and fatty acid composition, markers of inflammation and glycemic control, and serum metabolite profile.Discussion: The Canola-PAD Study uses an innovative and noninvasive approach to evaluate the effect of canola oil on clinically relevant outcomes in individuals with PAD, including

  12. Rationale and study protocol for a multi-component Health Information Technology (HIT) screening tool for depression and post-traumatic stress disorder in the primary care setting.

    Science.gov (United States)

    Biegler, Kelly; Mollica, Richard; Sim, Susan Elliott; Nicholas, Elisa; Chandler, Maria; Ngo-Metzger, Quyen; Paigne, Kittya; Paigne, Sompia; Nguyen, Danh V; Sorkin, Dara H

    2016-09-01

    The prevalence rate of depression in primary care is high. Primary care providers serve as the initial point of contact for the majority of patients with depression, yet, approximately 50% of cases remain unrecognized. The under-diagnosis of depression may be further exacerbated in limited English-language proficient (LEP) populations. Language barriers may result in less discussion of patients' mental health needs and fewer referrals to mental health services, particularly given competing priorities of other medical conditions and providers' time pressures. Recent advances in Health Information Technology (HIT) may facilitate novel ways to screen for depression and other mental health disorders in LEP populations. The purpose of this paper is to describe the rationale and protocol of a clustered randomized controlled trial that will test the effectiveness of an HIT intervention that provides a multi-component approach to delivering culturally competent, mental health care in the primary care setting. The HIT intervention has four components: 1) web-based provider training, 2) multimedia electronic screening of depression and PTSD in the patients' primary language, 3) Computer generated risk assessment scores delivered directly to the provider, and 4) clinical decision support. The outcomes of the study include assessing the potential of the HIT intervention to improve screening rates, clinical detection, provider initiation of treatment, and patient outcomes for depression and post-traumatic stress disorder (PTSD) among LEP Cambodian refugees who experienced war atrocities and trauma during the Khmer Rouge. This technology has the potential to be adapted to any LEP population in order to facilitate mental health screening and treatment in the primary care setting. Copyright © 2016 Elsevier Inc. All rights reserved.

  13. Rationale and Study Protocol for a Multi-component Health Information Technology (HIT) Screening Tool for Depression and Post-traumatic Stress Disorder in the Primary Care Setting

    Science.gov (United States)

    Biegler, Kelly; Mollica, Richard; Sim, Susan Elliott; Nicholas, Elisa; Chandler, Maria; Ngo-Metzger, Quyen; Paigne, Kittya; Paigne, Sompia; Nguyen, Danh V.; Sorkin, Dara H.

    2016-01-01

    The prevalence rate of depression in primary care is high. Primary care providers serve as the initial point of contact for the majority of patients with depression, yet, approximately 50% of cases remain unrecognized. The under-diagnosis of depression may be further exacerbated in limited English-language proficient (LEP) populations. Language barriers may result in less discussion of patients’ mental health needs and fewer referrals to mental health services, particularly given competing priorities of other medical conditions and providers’ time pressures. Recent advances in Health Information Technology (HIT) may facilitate novel ways to screen for depression in LEP populations. The purpose of this paper is to describe the rationale and protocol of a clustered-randomized controlled trial that will test the effectiveness of an HIT intervention that provides a multi-component approach to delivering culturally competent, mental health care in the primary care setting. The HIT intervention has four components: 1) web-based provider training, 2) multimedia electronic screening of depression and PTSD in the patients’ primary language, 3) Computer generated risk assessment scores delivered directly to the provider, and 4) clinical decision support. The outcomes of the study include assessing the potential of the HIT intervention to improve screening rates, clinical detection, provider initiation of treatment, and patient outcomes for depression and PTSD among LEP Cambodian refugees who experienced war atrocities and trauma during the Khmer Rouge. This technology has the potential to be adapted to any LEP population in order to facilitate mental health screening and treatment in the primary care setting. PMID:27394385

  14. The Nutrition and Enjoyable Activity for Teen Girls (NEAT girls) randomized controlled trial for adolescent girls from disadvantaged secondary schools: rationale, study protocol, and baseline results

    OpenAIRE

    Okely Anthony D; Plotnikoff Ronald C; Collins Clare E; Dewar Deborah; Morgan Philip J; Lubans David R; Batterham Marijka J; Finn Tara; Callister Robin

    2010-01-01

    Abstract Background Child and adolescent obesity predisposes individuals to an increased risk of morbidity and mortality from a range of lifestyle diseases. Although there is some evidence to suggest that rates of pediatric obesity have leveled off in recent years, this has not been the case among youth from low socioeconomic backgrounds. The purpose of this paper is to report the rationale, study design and baseline findings of a school-based obesity prevention program for low-active adolesc...

  15. Safe and effective prescription of exercise in acute exacerbations of chronic obstructive pulmonary disease: rationale and methods for an integrated knowledge translation study.

    Science.gov (United States)

    Camp, Pat; Reid, W Darlene; Yamabayashi, Cristiane; Brooks, Dina; Goodridge, Donna; Chung, Frank; Marciniuk, Darcy D; Neufeld, Andrea; Hoens, Alsion

    2013-01-01

    Patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) engage in low levels of activity, putting them at risk for relapse and future readmissions. There is little direction for health care providers regarding the parameters for safe exercise during an AECOPD that is effective for increasing activity tolerance before discharge from hospital, especially for patients with associated comorbid conditions. To report the rationale for and methods of a study to develop evidence-informed care recommendations that guide health care providers in the assessment, prescription, monitoring and progression of exercise for patients hospitalized with AECOPD. The present study was a multicomponent knowledge translation project incorporating evidence from systematic reviews of exercise involving populations with chronic obstructive pulmonary disease and⁄or common comorbidities. A Delphi process was then used to obtain expert opinion from clinicians, academics and patients to identify the parameters of safe and effective exercise for patients with AECOPD. Clinical decision-making tool(s) for patients and practitioners supported by a detailed knowledge dissemination, implementation and evaluation framework. The present study addressed an important knowledge gap: the lack of availability of parameters to guide safe and effective exercise prescription for hospitalized patients with AECOPD, with or without comorbid conditions. In the absence of such parameters, health care professionals may adopt an 'activity as tolerated' approach, which may not improve physical activity levels in their patients. The present study synthesizes the best available evidence and expert opinion, and will generate decision-making tools for use by patients and their health care providers.

  16. The development of criteria for limiting the non-uniform irradiation of skin: the rationale for a study of non-stochastic effects

    International Nuclear Information System (INIS)

    Wells, J.; Charles, M.W.

    1979-06-01

    Recent recommendations of the ICRP (1977) provide little guidance for the treatment of non-uniform skin exposures such as those which may occur as the result of contamination with radioactive particulates. This lack of guidance is due to a paucity of data regarding biological effects in this area. A rationale is presented for the study of the early (non-stochastic) effects of non-uniform skin irradiation. As a basis for the presentation of this rationale a framework is provided by a resume of basic biology of the skin and a review of previous experimental work in this field. Animal experiments, which are being carried out in collaboration with specialist university groups, are described both in terms of broad concept and experimental detail. The aim is to provide biological data which can provide guidance in radiological protection situations. (author)

  17. The Nutrition and Enjoyable Activity for Teen Girls (NEAT girls randomized controlled trial for adolescent girls from disadvantaged secondary schools: rationale, study protocol, and baseline results

    Directory of Open Access Journals (Sweden)

    Okely Anthony D

    2010-10-01

    Full Text Available Abstract Background Child and adolescent obesity predisposes individuals to an increased risk of morbidity and mortality from a range of lifestyle diseases. Although there is some evidence to suggest that rates of pediatric obesity have leveled off in recent years, this has not been the case among youth from low socioeconomic backgrounds. The purpose of this paper is to report the rationale, study design and baseline findings of a school-based obesity prevention program for low-active adolescent girls from disadvantaged secondary schools. Methods/Design The Nutrition and Enjoyable Activity for Teen Girls (NEAT Girls intervention will be evaluated using a group randomized controlled trial. NEAT Girls is a 12-month multi-component school-based intervention developed in reference to Social Cognitive Theory and includes enhanced school sport sessions, interactive seminars, nutrition workshops, lunch-time physical activity (PA sessions, PA and nutrition handbooks, parent newsletters, pedometers for self-monitoring and text messaging for social support. The following variables were assessed at baseline and will be completed again at 12- and 24-months: adiposity, objectively measured PA, muscular fitness, time spent in sedentary behaviors, dietary intake, PA and nutrition social-cognitive mediators, physical self-perception and global self-esteem. Statistical analyses will follow intention-to-treat principles and hypothesized mediators of PA and nutrition behavior change will be explored. Discussion NEAT Girls is an innovative intervention targeting low-active girls using evidence-based behavior change strategies and nutrition and PA messages and has the potential to prevent unhealthy weight gain and reduce the decline in physical activity and poor dietary habits associated with low socio-economic status. Few studies have reported the long-term effects of school-based obesity prevention programs and the current study has the potential to make an

  18. The Nutrition and Enjoyable Activity for Teen Girls (NEAT girls) randomized controlled trial for adolescent girls from disadvantaged secondary schools: rationale, study protocol, and baseline results.

    Science.gov (United States)

    Lubans, David R; Morgan, Philip J; Dewar, Deborah; Collins, Clare E; Plotnikoff, Ronald C; Okely, Anthony D; Batterham, Marijka J; Finn, Tara; Callister, Robin

    2010-10-28

    Child and adolescent obesity predisposes individuals to an increased risk of morbidity and mortality from a range of lifestyle diseases. Although there is some evidence to suggest that rates of pediatric obesity have leveled off in recent years, this has not been the case among youth from low socioeconomic backgrounds. The purpose of this paper is to report the rationale, study design and baseline findings of a school-based obesity prevention program for low-active adolescent girls from disadvantaged secondary schools. The Nutrition and Enjoyable Activity for Teen Girls (NEAT Girls) intervention will be evaluated using a group randomized controlled trial. NEAT Girls is a 12-month multi-component school-based intervention developed in reference to Social Cognitive Theory and includes enhanced school sport sessions, interactive seminars, nutrition workshops, lunch-time physical activity (PA) sessions, PA and nutrition handbooks, parent newsletters, pedometers for self-monitoring and text messaging for social support. The following variables were assessed at baseline and will be completed again at 12- and 24-months: adiposity, objectively measured PA, muscular fitness, time spent in sedentary behaviors, dietary intake, PA and nutrition social-cognitive mediators, physical self-perception and global self-esteem. Statistical analyses will follow intention-to-treat principles and hypothesized mediators of PA and nutrition behavior change will be explored. NEAT Girls is an innovative intervention targeting low-active girls using evidence-based behavior change strategies and nutrition and PA messages and has the potential to prevent unhealthy weight gain and reduce the decline in physical activity and poor dietary habits associated with low socio-economic status. Few studies have reported the long-term effects of school-based obesity prevention programs and the current study has the potential to make an important contribution to the field. Australian New Zealand Clinical

  19. ABDOMINAL TRAUMA- CLINICAL STUDY

    Directory of Open Access Journals (Sweden)

    Vanaja Ratnakumari Billa

    2017-08-01

    Full Text Available BACKGROUND In the recent times there has been increased incidence of abdominal trauma cases due to several causes. Quick and prompt intervention is needed to decrease the mortality of the patients. So we conducted a study to assess the cause and the management of abdominal trauma cases in our institution. The aim of this study was to know the incidence of blunt and penetrating injuries and their causes, age and sex incidence, importance of various investigations, mode of treatment offered and post-operative complications. To study the cause of death and evolve better management. MATERIALS AND METHODS The present study comprises of patients admitted to and operated in various surgical units in the Department of Surgery at Government General Hospital, attached to Guntur Medical College Guntur, from August 2014 to October 2016. RESULTS Increase incidence seen in age group 20-29 years (30%. Male predominance 77.5%. Mechanism of injury–road traffic accidents 65%. Isolated organ injury–colon and rectum 40%. Other associated injuries–chest injuries with rib fractures 7.5%. Complications–wound infection 17.5%. Duration of hospital stay 8–14 days. Bowel injury management–closure of perforation 84.6%. Resection anastomosis 15.38%. CONCLUSION Thorough clinical examination, diagnostic paracentesis, plain X-ray erect abdomen and ultrasound proved to be very helpful in the diagnosis of intra-abdominal injuries. Spleen is the commonest organ involved in blunt trauma and colon is the commonly injured organ in penetrating abdominal trauma, many patients have associated extremity and axial skeleton injuries. With advances in diagnosis and intensive care technologies, most patients of solid visceral injuries with hemodynamic stability can be managed conservatively. Surgical site infection is the most common complication following surgery. The mortality is high; reason might be patient reaching the hospital late, high incidence of postoperative septic

  20. Causes and consequences of cerebral small vessel disease. The RUN DMC study: a prospective cohort study. Study rationale and protocol

    Directory of Open Access Journals (Sweden)

    van der Vlugt Maureen J

    2011-02-01

    Full Text Available Abstract Background Cerebral small vessel disease (SVD is a frequent finding on CT and MRI scans of elderly people and is related to vascular risk factors and cognitive and motor impairment, ultimately leading to dementia or parkinsonism in some. In general, the relations are weak, and not all subjects with SVD become demented or get parkinsonism. This might be explained by the diversity of underlying pathology of both white matter lesions (WML and the normal appearing white matter (NAWM. Both cannot be properly appreciated with conventional MRI. Diffusion tensor imaging (DTI provides alternative information on microstructural white matter integrity. The association between SVD, its microstructural integrity, and incident dementia and parkinsonism has never been investigated. Methods/Design The RUN DMC study is a prospective cohort study on the risk factors and cognitive and motor consequences of brain changes among 503 non-demented elderly, aged between 50-85 years, with cerebral SVD. First follow up is being prepared for July 2011. Participants alive will be included and invited to the research centre to undergo a structured questionnaire on demographics and vascular risk factors, and a cognitive, and motor, assessment, followed by a MRI protocol including conventional MRI, DTI and resting state fMRI. Discussion The follow up of the RUN DMC study has the potential to further unravel the causes and possibly better predict the consequences of changes in white matter integrity in elderly with SVD by using relatively new imaging techniques. When proven, these changes might function as a surrogate endpoint for cognitive and motor function in future therapeutic trials. Our data could furthermore provide a better understanding of the pathophysiology of cognitive and motor disturbances in elderly with SVD. The execution and completion of the follow up of our study might ultimately unravel the role of SVD on the microstructural integrity of the white

  1. Causes and consequences of cerebral small vessel disease. The RUN DMC study: a prospective cohort study. Study rationale and protocol.

    Science.gov (United States)

    van Norden, Anouk Gw; de Laat, Karlijn F; Gons, Rob Ar; van Uden, Inge Wm; van Dijk, Ewoud J; van Oudheusden, Lucas Jb; Esselink, Rianne Aj; Bloem, Bastiaan R; van Engelen, Baziel Gm; Zwarts, Machiel J; Tendolkar, Indira; Olde-Rikkert, Marcel G; van der Vlugt, Maureen J; Zwiers, Marcel P; Norris, David G; de Leeuw, Frank-Erik

    2011-02-28

    Cerebral small vessel disease (SVD) is a frequent finding on CT and MRI scans of elderly people and is related to vascular risk factors and cognitive and motor impairment, ultimately leading to dementia or parkinsonism in some. In general, the relations are weak, and not all subjects with SVD become demented or get parkinsonism. This might be explained by the diversity of underlying pathology of both white matter lesions (WML) and the normal appearing white matter (NAWM). Both cannot be properly appreciated with conventional MRI. Diffusion tensor imaging (DTI) provides alternative information on microstructural white matter integrity. The association between SVD, its microstructural integrity, and incident dementia and parkinsonism has never been investigated. The RUN DMC study is a prospective cohort study on the risk factors and cognitive and motor consequences of brain changes among 503 non-demented elderly, aged between 50-85 years, with cerebral SVD. First follow up is being prepared for July 2011. Participants alive will be included and invited to the research centre to undergo a structured questionnaire on demographics and vascular risk factors, and a cognitive, and motor, assessment, followed by a MRI protocol including conventional MRI, DTI and resting state fMRI. The follow up of the RUN DMC study has the potential to further unravel the causes and possibly better predict the consequences of changes in white matter integrity in elderly with SVD by using relatively new imaging techniques. When proven, these changes might function as a surrogate endpoint for cognitive and motor function in future therapeutic trials. Our data could furthermore provide a better understanding of the pathophysiology of cognitive and motor disturbances in elderly with SVD. The execution and completion of the follow up of our study might ultimately unravel the role of SVD on the microstructural integrity of the white matter in the transition from "normal" aging to cognitive and

  2. Rationale and methods of the European Study on Cardiovascular Risk Prevention and Management in Daily Practice (EURIKA

    Directory of Open Access Journals (Sweden)

    Jiménez Francisco

    2010-06-01

    Full Text Available Abstract Background The EURIKA study aims to assess the status of primary prevention of cardiovascular disease (CVD across Europe. Specifically, it will determine the degree of control of cardiovascular risk factors in current clinical practice in relation to the European guidelines on cardiovascular prevention. It will also assess physicians' knowledge and attitudes about CVD prevention as well as the barriers impeding effective risk factor management in clinical practice. Methods/Design Cross-sectional study conducted simultaneously in 12 countries across Europe. The study has two components: firstly at the physician level, assessing eight hundred and nine primary care and specialist physicians with a daily practice in CVD prevention. A physician specific questionnaire captures information regarding physician demographics, practice settings, cardiovascular prevention beliefs and management. Secondly at the patient level, including 7641 patients aged 50 years or older, free of clinical CVD and with at least one classical risk factor, enrolled by the participating physicians. A patient-specific questionnaire captures information from clinical records and patient interview regarding sociodemographic data, CVD risk factors, and current medications. Finally, each patient provides a fasting blood sample, which is sent to a central laboratory for measuring serum lipids, apolipoproteins, hemoglobin-A1c, and inflammatory biomarkers. Discussion Primary prevention of CVD is an extremely important clinical issue, with preventable circulatory diseases remaining the leading cause of major disease burden. The EURIKA study will provide key information to assess effectiveness of and attitudes toward primary prevention of CVD in Europe. A transnational study creates opportunities for benchmarking good clinical practice across countries and improving outcomes. (ClinicalTrials.gov number, NCT00882336.

  3. Population-based multicase-control study in common tumors in Spain (MCC-Spain): rationale and study design.

    Science.gov (United States)

    Castaño-Vinyals, Gemma; Aragonés, Nuria; Pérez-Gómez, Beatriz; Martín, Vicente; Llorca, Javier; Moreno, Victor; Altzibar, Jone M; Ardanaz, Eva; de Sanjosé, Sílvia; Jiménez-Moleón, José Juan; Tardón, Adonina; Alguacil, Juan; Peiró, Rosana; Marcos-Gragera, Rafael; Navarro, Carmen; Pollán, Marina; Kogevinas, Manolis

    2015-01-01

    We present the protocol of a large population-based case-control study of 5 common tumors in Spain (MCC-Spain) that evaluates environmental exposures and genetic factors. Between 2008-2013, 10,183 persons aged 20-85 years were enrolled in 23 hospitals and primary care centres in 12 Spanish provinces including 1,115 cases of a new diagnosis of prostate cancer, 1,750 of breast cancer, 2,171 of colorectal cancer, 492 of gastro-oesophageal cancer, 554 cases of chronic lymphocytic leukaemia (CLL) and 4,101 population-based controls matched by frequency to cases by age, sex and region of residence. Participation rates ranged from 57% (stomach cancer) to 87% (CLL cases) and from 30% to 77% in controls. Participants completed a face-to-face computerized interview on sociodemographic factors, environmental exposures, occupation, medication, lifestyle, and personal and family medical history. In addition, participants completed a self-administered food-frequency questionnaire and telephone interviews. Blood samples were collected from 76% of participants while saliva samples were collected in CLL cases and participants refusing blood extractions. Clinical information was recorded for cases and paraffin blocks and/or fresh tumor samples are available in most collaborating hospitals. Genotyping was done through an exome array enriched with genetic markers in specific pathways. Multiple analyses are planned to assess the association of environmental, personal and genetic risk factors for each tumor and to identify pleiotropic effects. This study, conducted within the Spanish Consortium for Biomedical Research in Epidemiology & Public Health (CIBERESP), is a unique initiative to evaluate etiological factors for common cancers and will promote cancer research and prevention in Spain. Copyright © 2014 SESPAS. Published by Elsevier Espana. All rights reserved.

  4. Rationale, description and baseline findings of a community-based prospective cohort study of kidney function amongst the young rural population of Northwest Nicaragua.

    Science.gov (United States)

    González-Quiroz, Marvin; Camacho, Armando; Faber, Dorien; Aragón, Aurora; Wesseling, Catharina; Glaser, Jason; Le Blond, Jennifer; Smeeth, Liam; Nitsch, Dorothea; Pearce, Neil; Caplin, Ben

    2017-01-13

    An epidemic of Mesoamerican Nephropathy (MeN) is killing thousands of agricultural workers along the Pacific coast of Central America, but the natural history and aetiology of the disease remain poorly understood. We have recently commenced a community-based longitudinal study to investigate Chronic Kidney Disease (CKD) in Nicaragua. Although logistically challenging, study designs of this type have the potential to provide important insights that other study designs cannot. In this paper we discuss the rationale for conducting this study and summarize the findings of the baseline visit. The baseline visit of the community-based cohort study was conducted in 9 communities in the North Western Nicaragua in October and November 2014. All of the young men, and a random sample of young women (aged 18-30) without a pre-existing diagnosis of CKD were invited to participate. Glomerular filtration rate (eGFR) was estimated with CKD-EPI equation, along with clinical measurements, questionnaires, biological and environmental samples to evaluate participants' exposures to proposed risk factors for MeN. We identified 520 young adults (286 males and 234 females) in the 9 different communities. Of these, 16 males with self-reported CKD and 5 females with diagnoses of either diabetes or hypertension were excluded from the study population. All remaining 270 men and 90 women, selected at random, were then invited to participate in the study; 350 (97%) agreed to participate. At baseline, 29 (11%) men and 1 (1%) woman had an eGFR <90 mL/min/1.73 m 2 . Conducting a community based study of this type requires active the involvement of communities and commitment from local leaders. Furthermore, a research team with strong links to the area and broad understanding of the context of the problem being studied is essential. The key findings will arise from follow-up, but it is striking that 5% of males under aged 30 had to be excluded because of pre-existing kidney disease, and that

  5. Hanford waste-form release and sediment interaction: A status report with rationale and recommendations for additional studies

    International Nuclear Information System (INIS)

    Serne, R.J.; Wood, M.I.

    1990-05-01

    This report documents the currently available geochemical data base for release and retardation for actual Hanford Site materials (wastes and/or sediments). The report also recommends specific laboratory tests and presents the rationale for the recommendations. The purpose of this document is threefold: to summarize currently available information, to provide a strategy for generating additional data, and to provide recommendations on specific data collection methods and tests matrices. This report outlines a data collection approach that relies on feedback from performance analyses to ascertain when adequate data have been collected. The data collection scheme emphasizes laboratory testing based on empiricism. 196 refs., 4 figs., 36 tabs

  6. Effects of Role and Assignment Rationale on Attitudes Formed During Peer Tutoring

    Science.gov (United States)

    Bierman, Karen Linn; Furman, Wyndol

    2012-01-01

    This study examined the role of contextual factors, such as assignment rationale, on the attitudinal effects of peer tutoring. Fourth-grade children engaged in brief tutoring experiences as either a tutor or tutee. Subjects received four rationales for being selected as tutor or tutee: (a) a competence rationale, (b) a physical characteristic rationale, (c) a chance rationale, or (d) no rationale. As predicted, tutors had more positive attitudes than tutees when they had been given a competence or physical characteristic rationale but not when the tutors were provided a chance rationale or no rationale. Additionally, the tutors’ and tutees’ attitudes were enhanced when no rationale was provided. Results are discussed in terms of their implications for a role-theory analysis of tutoring and their implications for applied programs. PMID:23946549

  7. clinical and experimental study

    OpenAIRE

    Tornow, Christoph

    2011-01-01

    Posterior capsule opacity (PCO) is a frequent complication in extracapsular cataract extraction in conjunction with an intraocular lens implant. Different studies have shown that a reduction in PCO frequency can be achieved via a number of factors. Lens design is a significant criterion in this process. In this study, two multifocal intraocular lenses (MIOLs) were compared. The design of these lenses differed due to their varying optical principles. They are the refractive MIOL A...

  8. Efficacy, safety and tolerability of simvastatin in children with familial hypercholesterolaemia - Rationale, design and baseline characteristics

    NARCIS (Netherlands)

    de Jongh, S.; Stalenhoef, A. F. H.; Tuohy, M. B.; Mercuri, M.; Bakker, H. D.; Kastelein, J. J. P.

    2002-01-01

    Objective: To describe the rationale, design and baseline data of a study conducted to determine the efficacy, safety and tolerability of simvastatin in children and adolescents with heterozygous familial hypercholesterolaemia (heFH). Methods: Patients were recruited from nine lipid clinics

  9. Controlled study of myocardial recovery after interval training in heart failure: SMARTEX-HF - rationale and design

    DEFF Research Database (Denmark)

    Støylen, Asbjørn; Conraads, Viviane; Halle, Martin

    2011-01-01

    in patients with chronic heart failure. However, the size of beneficial effects was modest compared to results published in smaller single studies and meta-analyses. Objective: Based on results of a pilot study, the objective of the present investigation is to test the hypothesis that a programme comprising...... number of 200 patients on treatment per protocol, randomized to the three groups in a 1 : 1 : 1 manner, is estimated to detect clinically relevant differences in effect with HIT vs. MCT and RE (p run...

  10. Barriers to successful implementation of care in home haemodialysis (BASIC-HHD):1. Study design, methods and rationale.

    Science.gov (United States)

    Jayanti, Anuradha; Wearden, Alison J; Morris, Julie; Brenchley, Paul; Abma, Inger; Bayer, Steffen; Barlow, James; Mitra, Sandip

    2013-09-17

    Ten years on from the National Institute of Health and Clinical Excellence' technology appraisal guideline on haemodialysis in 2002; the clinical community is yet to rise to the challenge of providing home haemodialysis (HHD) to 10-15% of the dialysis cohort. The renal registry report, suggests underutilization of a treatment type that has had a lot of research interest and several publications worldwide on its apparent benefit for both physical and mental health of patients. An understanding of the drivers to introducing and sustaining the modality, from organizational, economic, clinical and patient perspectives is fundamental to realizing the full benefits of the therapy with the potential to provide evidence base for effective care models. Through the BASIC-HHD study, we seek to understand the clinical, patient and carer related psychosocial, economic and organisational determinants of successful uptake and maintenance of home haemodialysis and thereby, engage all major stakeholders in the process. We have adopted an integrated mixed methodology (convergent, parallel design) for this study. The study arms include a. patient; b. organization; c. carer and d. economic evaluation. The three patient study cohorts (n = 500) include pre-dialysis patients (200), hospital haemodialysis (200) and home haemodialysis patients (100) from geographically distinct NHS sites, across the country and with variable prevalence of home haemodialysis. The pre-dialysis patients will also be prospectively followed up for a period of 12 months from study entry to understand their journey to renal replacement therapy and subsequently, before and after studies will be carried out for a select few who do commence dialysis in the study period. The process will entail quantitative methods and ethnographic interviews of all groups in the study. Data collection will involve clinical and biomarkers, psychosocial quantitative assessments and neuropsychometric tests in patients. Organizational

  11. Instantaneous Wave-Free Ratio versus Fractional Flow Reserve guided intervention (iFR-SWEDEHEART): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial.

    Science.gov (United States)

    Götberg, Matthias; Christiansen, Evald H; Gudmundsdottir, Ingibjörg; Sandhall, Lennart; Omerovic, Elmir; James, Stefan K; Erlinge, David; Fröbert, Ole

    2015-11-01

    Instantaneous wave-free ratio (iFR) is a new hemodynamic resting index for assessment of coronary artery stenosis severity. iFR uses high frequency sampling to calculate a gradient across a coronary lesion during a period of diastole. The index has been tested against fractional flow reserve (FFR) and found to have an overall classification agreement of 80% to 85%. Whether the level of disagreement is clinically relevant is unknown. Clinical outcome data on iFR are scarce. This study is a registry-based randomized clinical trial, which is a novel strategy using health quality registries as on-line platforms for randomization, case record forms, and follow-up. iFR-SWEDEHEART is a multicenter, prospective, randomized, controlled, clinical open-label clinical trial. Two thousand patients with stable angina or acute coronary syndrome and an indication for physiology-guided assessment of one or more coronary stenoses will be randomized 1:1 to either iFR- or FFR-guided intervention. The randomization will be conducted online in the Swedish web-based system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART) registry. The trial has a non-inferiority design, with a primary combined end point of all-cause death, non-fatal myocardial infarction, and unplanned revascularization at 12 months. End points will be identified through national registries and undergo central blind adjudication to ensure data quality. The iFR-SWEDEHEART trial is an registry-based randomized clinical trial evaluating the safety and efficacy of the diagnostic method iFR compared to FFR. Copyright © 2015 Elsevier Inc. All rights reserved.

  12. Design and rationale of the HCC BRIDGE study in China: a longitudinal, multicenter cohort trial in hepatocellular carcinoma

    Directory of Open Access Journals (Sweden)

    Qiao You-Lin

    2011-05-01

    Full Text Available Abstract Background More than 50% of the worldwide cases of hepatocellular carcinoma occur in China, and this malignancy currently represents the country's second leading cause of cancer death in cities and the leading cause in rural areas. Despite recent advances in the control and management of hepatocellular carcinoma within China, this disease remains a major health care issue. The global HCC BRIDGE study, designed to assess patterns of hepatocellular carcinoma therapy use and associated outcomes across real-world clinical practice, has recently been expanded as a national study in China, allowing a detailed analysis of hepatocellular carcinoma in this important country. Methods/Design The global HCC BRIDGE study is a multiregional longitudinal cohort trial including patients newly diagnosed with hepatocellular carcinoma between January 1, 2005, and June 30, 2011, who are receiving treatment for hepatocellular carcinoma via sites in the Asia-Pacific, European, and North American regions. The HCC BRIDGE China national study comprises the portion of the global HCC BRIDGE study conducted within mainland China. Patients will be followed from time of diagnosis of hepatocellular carcinoma (post-January 1, 2005 to time of death or December 31, 2011, whichever comes first. Data will be collected on demographic/clinical characteristics, relevant laboratory values, hepatocellular carcinoma/underlying liver disease treatment, tumor response, adverse events, hospitalizations, and overall survival. The primary study end point is overall survival; secondary end points are disease progression, treatment-limiting adverse events, and treatment failure. Results At the time of writing, 15 sites have selected for participation across all 7 traditional regions of China (North, North-East, East, South, South-West, North-West, and Central. The anticipated study population from the China national study is approximately 9000 patients. Discussion Findings from the

  13. The Korean Study of Women’s Health-Related Issues (K-Stori: Rationale and Study Design

    Directory of Open Access Journals (Sweden)

    Ha Na Cho

    2017-06-01

    Full Text Available Abstract Background Measures to address gender-specific health issues are essential due to fundamental, biological differences between the sexes. Studies have increasingly stressed the importance of customizing approaches directed at women’s health issues according to stages in the female life cycle. In Korea, however, gender-specific studies on issues affecting Korean women in relation to stages in their life cycle are lacking. Accordingly, the Korean Study of Women’s Health-Related Issues (K-Stori was designed to investigate life cycle-specific health issues among women, covering health status, awareness, and risk perceptions. Methods K-Stori was conducted as a nationwide cross-sectional survey targeting Korean women aged 14–79 years. Per each stage in the female life cycle (adolescence, childbearing age, pregnancy & postpartum, menopause, and older adult stage, 3000 women (total 15,000 were recruited by stratified multistage random sampling for geographic area based on the 2010 Resident Registration Population in Korea. Specialized questionnaires per each stage (total of five were developed in consultation with multidisciplinary experts and by reflecting upon current interests into health among the general population of women in Korea. This survey was conducted from April 1 to June 31, 2016, at which time investigators from a professional research agency went door-to-door to recruit residents and conducted in-person interviews. Discussion The study’s findings may help with elucidating health issues and unmet needs specific to each stage in the life cycle of Korean women that have yet to be identified in present surveys.

  14. Case study research as bridge builder between science and the society. The rationale behind the ASTRA 2005 winter storm study

    Energy Technology Data Exchange (ETDEWEB)

    Haanpaeae, S.; Peltonen, L.

    2007-07-01

    The challenge of climate change as a complex global issue is that it demands locally grounded solutions that bring together actors from various fields. As a 'wicked' problem climate change adaptation demands deliberation between different subsystems of society, including scientific research. While answering the complex needs of the society, it has to be re-evaluated what 'good' science means. This brings about a need for socially robust knowledge. The need for contextualisation of scientific knowledge is supported by theoretical development in the fields of policy analysis and risk governance. It also entails an epistemic shift away from the 'quest for certainty' towards a pragmatist understanding of knowledge. The underlying request is to integrate expert knowledge with the needs of other stakeholders - to bring in the people to add to the policy formation a notion of emotional knowledge. As a research method, case studies readily contextualise scientific information and therefore offer valuable insights into the underlying social values of the problems at hand. As locally grounded narratives they can offer a shortcut to the formation of a new kind of expertise needed as the demands from the society reform the claims on scientific information. It is argued that developing the science-policy interface and risk communication can both benefit from a contextual research approach using case studies. Such studies have critical and persuasive functions, and they provide a basis for further case-based learning exercises with opportunities for awareness raising, institutional capacity building and practical adaptation measures. (orig.)

  15. Rationale, design, and methods for Canadian alliance for healthy hearts and minds cohort study (CAHHM) - a Pan Canadian cohort study.

    Science.gov (United States)

    Anand, Sonia S; Tu, Jack V; Awadalla, Philip; Black, Sandra; Boileau, Catherine; Busseuil, David; Desai, Dipika; Després, Jean-Pierre; de Souza, Russell J; Dummer, Trevor; Jacquemont, Sébastien; Knoppers, Bartha; Larose, Eric; Lear, Scott A; Marcotte, Francois; Moody, Alan R; Parker, Louise; Poirier, Paul; Robson, Paula J; Smith, Eric E; Spinelli, John J; Tardif, Jean-Claude; Teo, Koon K; Tusevljak, Natasa; Friedrich, Matthias G

    2016-07-27

    The Canadian Alliance for Healthy Hearts and Minds (CAHHM) is a pan-Canadian, prospective, multi-ethnic cohort study being conducted in Canada. The overarching objective of the CAHHM is to understand the association of socio-environmental and contextual factors (such as societal structure, activity, nutrition, social and tobacco environments, and access to health services) with cardiovascular risk factors, subclinical vascular disease, and cardiovascular and other chronic disease outcomes. Participants between 35 and 69 years of age are being recruited from existing cohorts and a new First Nations Cohort to undergo a detailed assessment of health behaviours (including diet and physical activity), cognitive function, assessment of their local home and workplace environments, and their health services access and utilization. Physical measures including weight, height, waist/hip circumference, body fat percentage, and blood pressure are collected. In addition, eligible participants undergo magnetic resonance imaging (MRI) of the brain, heart, carotid artery and abdomen to detect early subclinical vascular disease and ectopic fat deposition. CAHHM is a prospective cohort study designed to investigate the impact of community level factors, individual health behaviours, and access to health services, on cognitive function, subclinical vascular disease, fat distribution, and the development of chronic diseases among adults living in Canada.

  16. Rationale and design of the GUIDE-IT study: Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.

    Science.gov (United States)

    Felker, G Michael; Ahmad, Tariq; Anstrom, Kevin J; Adams, Kirkwood F; Cooper, Lawton S; Ezekowitz, Justin A; Fiuzat, Mona; Houston-Miller, Nancy; Januzzi, James L; Leifer, Eric S; Mark, Daniel B; Desvigne-Nickens, Patrice; Paynter, Gayle; Piña, Ileana L; Whellan, David J; O'Connor, Christopher M

    2014-10-01

    The GUIDE-IT (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) study is designed to determine the safety, efficacy, and cost-effectiveness of a strategy of adjusting therapy with the goal of achieving and maintaining a target N-terminal pro-B-type natriuretic peptide (NT-proBNP) level of levels provide key prognostic information in patients with HF. Therapies proven to improve outcomes in patients with HF are generally associated with decreasing levels of NPs, and observational data show that decreases in NP levels over time are associated with favorable outcomes. Results from smaller prospective, randomized studies of this strategy thus far have been mixed, and current guidelines do not recommend serial measurement of NP levels to guide therapy in patients with HF. GUIDE-IT is a prospective, randomized, controlled, unblinded, multicenter clinical trial designed to randomize approximately 1,100 high-risk subjects with systolic HF (left ventricular ejection fraction ≤40%) to either usual care (optimized guideline-recommended therapy) or a strategy of adjusting therapy with the goal of achieving and maintaining a target NT-proBNP level of study are followed up at regular intervals and after treatment adjustments for a minimum of 12 months. The primary endpoint of the study is time to cardiovascular death or first hospitalization for HF. Secondary endpoints include time to cardiovascular death and all-cause mortality, cumulative mortality, health-related quality of life, resource use, cost-effectiveness, and safety. The GUIDE-IT study is designed to definitively assess the effects of an NP-guided strategy in high-risk patients with systolic HF on clinically relevant endpoints of mortality, hospitalization, quality of life, and medical resource use. (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure [GUIDE-IT]; NCT01685840). Copyright © 2014 American College of Cardiology Foundation

  17. Rationale and design of the DARWIN-T2D (DApagliflozin Real World evIdeNce in Type 2 Diabetes): A multicenter retrospective nationwide Italian study and crowdsourcing opportunity.

    Science.gov (United States)

    Fadini, G P; Zatti, G; Consoli, A; Bonora, E; Sesti, G; Avogaro, A

    2017-12-01

    Randomized controlled trials (RCTs) in the field of diabetes have limitations inherent to the fact that design, setting, and patient characteristics may be poorly transferrable to clinical practice. Thus, evidence from studies using routinely accumulated clinical data are increasingly valued. We herein describe rationale and design of the DARWIN-T2D (DApagliflozin Real World evIdeNce in Type 2 Diabetes), a multicenter retrospective nationwide study conducted at 50 specialist outpatient clinics in Italy and promoted by the Italian Diabetes Society. The primary objective of the study is to describe the baseline clinical characteristics (particularly HbA1c) of patients initiated on dapagliflozin from marketing authorization approval to the end of 2016. Secondary and exploratory objectives will evaluate the changes in glycaemic and extraglycaemic efficacy parameters after initiation of dapagliflozin or after initiation of comparator glucose lowering medications (DPP-4 inhibitors, gliclazide extended release, and long-acting GLP-1 receptor agonists). An automated software will extract relevant data from the same electronic chart system at all centres, thereby minimizing data treatment and human intervention. The study is expected to collect an enormous dataset of information on dapagliflozin- and comparator-using patients. After study completion, the Italian Diabetes Society will launch an open crowdsourcing call on the DARWIN-T2D database, challenging diabetes researchers to apply their ideas and approaches to address new unmet needs and knowledge gaps in diabetes. We believe this will move DARWIN-T2D to the next generation of real world studies. Copyright © 2017 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.

  18. Study protocol and rationale for a randomized double-blinded crossover trial of phentermine-topiramate ER versus placebo to treat binge eating disorder and bulimia nervosa.

    Science.gov (United States)

    Dalai, Shebani Sethi; Adler, Sarah; Najarian, Thomas; Safer, Debra Lynn

    2018-01-01

    Bulimia nervosa (BN) and binge eating disorder (BED) are associated with severe psychological and medical consequences. Current therapies are limited, leaving up to 50% of patients symptomatic despite treatment, underscoring the need for additional treatment options. Qsymia, an FDA-approved medication for obesity, combines phentermine and topiramate ER. Topiramate has demonstrated efficacy for both BED and BN, but limited tolerability. Phentermine is FDA-approved for weight loss. A rationale for combined phentermine/topiramate for BED and BN is improved tolerability and efficacy. While a prior case series exploring Qsymia for BED showed promise, randomized studies are needed to evaluate Qsymia's safety and efficacy when re-purposed in eating disorders. We present a study protocol for a Phase I/IIa single-center, prospective, double-blinded, randomized, crossover trial examining safety and preliminary efficacy of Qsymia for BED and BN. Adults with BED (n=15) or BN (n=15) are randomized 1:1 to receive 12weeks Qsymia (phentermine/topiramate ER, 3.75mg/23mg-15mg/92mg) or placebo, followed by 2-weeks washout and 12-weeks crossover, where those on Qsymia receive placebo and vice versa. Subsequently participants receive 8weeks follow-up off study medications. The primary outcome is the number of binge days/week measured by EDE. Secondary outcomes include average number of binge episodes, percentage abstinence from binge eating, and changes in weight/vitals, eating psychopathology, and mood. To our knowledge this is the first randomized, double-blind protocol investigating the safety and efficacy of phentermine/topiramate in BED and BN. We highlight the background and rationale for this study, including the advantages of a crossover design. Clinicaltrials.gov identifier NCT02553824 registered on 9/17/2015. https://clinicaltrials.gov/ct2/show/NCT02553824. Copyright © 2017 Elsevier Inc. All rights reserved.

  19. Antibiotics for bronchiectasis exacerbations in children: rationale and study protocol for a randomised placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Chang Anne B

    2012-08-01

    Full Text Available Abstract Background Despite bronchiectasis being increasingly recognised as an important cause of chronic respiratory morbidity in both indigenous and non-indigenous settings globally, high quality evidence to inform management is scarce. It is assumed that antibiotics are efficacious for all bronchiectasis exacerbations, but not all practitioners agree. Inadequately treated exacerbations may risk lung function deterioration. Our study tests the hypothesis that both oral azithromycin and amoxicillin-clavulanic acid are superior to placebo at improving resolution rates of respiratory exacerbations by day 14 in children with bronchiectasis unrelated to cystic fibrosis. Methods We are conducting a bronchiectasis exacerbation study (BEST, which is a multicentre, randomised, double-blind, double-dummy, placebo-controlled, parallel group trial, in five centres (Brisbane, Perth, Darwin, Melbourne, Auckland. In the component of BEST presented here, 189 children fulfilling inclusion criteria are randomised (allocation-concealed to receive amoxicillin-clavulanic acid (22.5 mg/kg twice daily with placebo-azithromycin; azithromycin (5 mg/kg daily with placebo-amoxicillin-clavulanic acid; or placebo-azithromycin with placebo-amoxicillin-clavulanic acid for 14 days. Clinical data and a paediatric cough-specific quality of life score are obtained at baseline, at the start and resolution of exacerbations, and at day 14. In most children, blood and deep nasal swabs are also collected at the same time points. The primary outcome is the proportion of children whose exacerbations have resolved at day 14. The main secondary outcome is the paediatric cough-specific quality of life score. Other outcomes are time to next exacerbation; requirement for hospitalisation; duration of exacerbation; and spirometry data. Descriptive viral and bacteriological data from nasal samples and blood markers will also be reported. Discussion Effective, evidence-based management

  20. Pro-HEART - a randomized clinical trial to test the effectiveness of a high protein diet targeting obese individuals with heart failure: rationale, design and baseline characteristics.

    Science.gov (United States)

    Motie, Marjan; Evangelista, Lorraine S; Horwich, Tamara; Hamilton, Michele; Lombardo, Dawn; Cooper, Dan M; Galassetti, Pietro R; Fonarow, Gregg C

    2013-11-01

    There is ample research to support the potential benefits of a high protein diet on clinical outcomes in overweight/obese, diabetic subjects. However, nutritional management of overweight/obese individuals with heart failure (HF) and type 2 diabetes mellitus (DM) or metabolic syndrome (MS) is poorly understood and few clinical guidelines related to nutritional approaches exist for this subgroup. This article describes the design, methods, and baseline characteristics of study participants enrolled in Pro-HEART, a randomized clinical trial to determine the short term and long term effects of a high protein diet (30% protein [~110 g/day], 40% carbohydrates [150 g/day], 30% fat [~50 g/day]) versus a standard protein diet (15% protein [~55 g/day], 55% carbohydrates [~200 g/day], 30% fat [~50 g/day]) on body weight and adiposity, cardiac structure and function, functional status, lipid profile, glycemic control, and quality of life. Between August, 2009 and May, 2013, 61 individuals agreed to participate in the study; 52 (85%) - mean age 58.2 ± 9.8 years; 15.4% Blacks; 57.7% Whites; 19.2% Hispanics; 7.7% Asians; 73.1% male; weight 112.0 ± 22.6 kg - were randomized to a 3-month intensive weight management program of either a high protein or standard protein diet; data were collected at baseline, 3 months, and 15 months. This study has the potential to reveal significant details about the role of macronutrients in weight management of overweight/obese individuals with HF and DM or MS. © 2013 Elsevier Inc. All rights reserved.

  1. A randomized controlled trial on the effectiveness of strength training on clinical and muscle cellular outcomes in patients with prostate cancer during androgen deprivation therapy: rationale and design

    International Nuclear Information System (INIS)

    Thorsen, Lene; Nilsen, Tormod S; Raastad, Truls; Courneya, Kerry S; Skovlund, Eva; Fosså, Sophie D

    2012-01-01

    Studies indicate that strength training has beneficial effects on clinical health outcomes in prostate cancer patients during androgen deprivation therapy. However, randomized controlled trials are needed to scientifically determine the effectiveness of strength training on the muscle cell level. Furthermore, close examination of the feasibility of a high-load strength training program is warranted. The Physical Exercise and Prostate Cancer (PEPC) trial is designed to determine the effectiveness of strength training on clinical and muscle cellular outcomes in non-metastatic prostate cancer patients after high-dose radiotherapy and during ongoing androgen deprivation therapy. Patients receiving androgen deprivation therapy for 9-36 months combined with external high-dose radiotherapy for locally advanced prostate cancer are randomized to an exercise intervention group that receives a 16 week high-load strength training program or a control group that is encouraged to maintain their habitual activity level. In both arms, androgen deprivation therapy is continued until the end of the intervention period. Clinical outcomes are body composition (lean body mass, bone mineral density and fat mass) measured by Dual-energy X-ray Absorptiometry, serological outcomes, physical functioning (muscle strength and cardio-respiratory fitness) assessed with physical tests and psycho-social functioning (mental health, fatigue and health-related quality of life) assessed by questionnaires. Muscle cellular outcomes are a) muscle fiber size b) regulators of muscle fiber size (number of myonuclei per muscle fiber, number of satellite cells per muscle fiber, number of satellite cells and myonuclei positive for androgen receptors and proteins involved in muscle protein degradation and muscle hypertrophy) and c) regulators of muscle fiber function such as proteins involved in cellular stress and mitochondrial function. Muscle cellular outcomes are measured on muscle cross sections and

  2. The Fifth German Oral Health Study (Fünfte Deutsche Mundgesundheitsstudie, DMS V) - rationale, design, and methods.

    Science.gov (United States)

    Jordan, Rainer A; Bodechtel, Constanze; Hertrampf, Katrin; Hoffmann, Thomas; Kocher, Thomas; Nitschke, Ina; Schiffner, Ulrich; Stark, Helmut; Zimmer, Stefan; Micheelis, Wolfgang

    2014-12-29

    Oral diseases rank among the most prevalent non-communicable diseases in modern societies. In Germany, oral epidemiological data show that both dental caries and periodontal diseases are highly prevalent, though significant improvements in oral health has been taking in the population within the last decades, particularly in children. It is, therefore, the aim of the Fifth German Oral Health Study (DMS V) to actualize the data on current oral health status and to gather information on oral health behavior and risk factors. In addition to current oral health monitoring, the study will also permit conclusions about trends in the development of oral health in Germany between 1989 and 2014. DMS V is a cross-sectional, multi-center, nationwide representative, socio-epidemiological study to investigate the oral health status und behavior of the German resident population in four age cohorts. Study participants are children (12-year-olds), adults (35- to 44-year-olds), young olds (65- to 74-year-olds), and old olds (75- to 100-year-olds) who are drawn from local residents' registration offices. Social-science investigation parameters concern subjective perceptions and attitudes regarding oral health and nutrition, sense of coherence, and socio-demographic data. Clinical oral parameters are tooth loss, caries and periodontitis, prosthodontic status, further developmental and acquired dental hard tissue and mucosal lesions. To ensure reproducibility, the dental investigators are trained and calibrated by experts and multiple reliability checks are performed throughout the field phase. Statistical analyses are calculated according to a detailed statistical analysis plan. The DMS studies first performed in 1989, 1992 and repeated in 1997 and 2005 are the only cross-sectional oral health studies conducted in Germany on a population-based national representative level. Updated prevalence and trend analyses of key oral diseases are, therefore, of major epidemiological and health

  3. Breast ductal lavage for biomarker assessment in high risk women: rationale, design and methodology of a randomized phase II clinical trial with nimesulide, simvastatin and placebo

    International Nuclear Information System (INIS)

    Lazzeroni, Matteo; Radice, Davide; Bonanni, Bernardo; Guerrieri-Gonzaga, Aliana; Serrano, Davide; Cazzaniga, Massimiliano; Mora, Serena; Casadio, Chiara; Jemos, Costantino; Pizzamiglio, Maria; Cortesi, Laura

    2012-01-01

    Despite positive results from large phase III clinical trials proved that it is possible to prevent estrogen-responsive breast cancers with selective estrogen receptor modulators and aromatase inhibitors, no significant results have been reached so far to prevent hormone non-responsive tumors. The Ductal Lavage (DL) procedure offers a minimally invasive method to obtain breast epithelial cells from the ductal system for cytopathologic analysis. Several studies with long-term follow-up have shown that women with atypical hyperplasia have an elevated risk of developing breast cancer. The objective of the proposed trial is to assess the efficacy and safety of a daily administration of nimesulide or simvastatin in women at higher risk for breast cancer, focused particularly on hormone non-responsive tumor risk. The primary endpoint is the change in prevalence of atypical cells and cell proliferation (measured by Ki67) in DL or fine needle aspirate samples, after 12 months of treatment and 12 months after treatment cessation. From 2005 to 2011, 150 women with a history of estrogen receptor negative ductal intraepithelial neoplasia or lobular intraepithelial neoplasia or atypical hyperplasia, or unaffected subjects carrying a mutation of BRCA1 or with a probability of mutation >10% (according to BRCAPRO) were randomized to receive nimesulide 100mg/day versus simvastatin 20mg/day versus placebo for one year followed by a second year of follow-up. This is the first randomized placebo controlled trial to evaluate the role of DL to study surrogate endpoints biomarkers and the effects of these drugs on breast carcinogenesis. In 2007 the European Medicines Agency limited the use of systemic formulations of nimesulide to 15 days. According to the European Institute of Oncology Ethics Committee communication, we are now performing an even more careful monitoring of the study participants. Preliminary results showed that DL is a feasible procedure, the treatment is well tolerated

  4. Rationale and design of a randomized double-blind clinical trial in breast cancer: dextromethorphan in chemotherapy-induced peripheral neuropathy.

    Science.gov (United States)

    Martin, Elodie; Morel, Véronique; Joly, Dominique; Villatte, Christine; Delage, Noémie; Dubray, Claude; Pereira, Bruno; Pickering, Gisèle

    2015-03-01

    Anti-cancer chemotherapy often induces peripheral neuropathy and consequent cognitive and quality of life impairment. Guidelines recommend antiepileptics or antidepressants but their efficacy is limited.Dextromethorphan, a N-methyl-D-aspartate receptor antagonist, has shown its efficacy in painful diabetic neuropathy and in post-operative pain but has not been studied in chemotherapy-induced peripheral neuropathy. This clinical trial evaluates the effect of dextromethorphan on pain, cognition and quality of life in patients who suffer from neuropathic pain induced by chemotherapy for breast cancer. It also assesses the impact of dextromethorphan genetic polymorphism on analgesia. This trial is a randomized, placebo-controlled, double-blind clinical study in two parallel groups (NCT02271893). It includes 40 breast cancer patients suffering from chemotherapy-induced peripheral neuropathy. They are randomly allocated to dextromethorphan (maximal dose 90 mg/day) or placebo for 4 weeks. The primary endpoint is pain intensity measured after 4 weeks of treatment on a (0-10) Numeric Pain Rating Scale. Secondary outcomes include assessment of neuropathic pain, cognitive function, anxiety/depression, sleep and quality of life. Data analysis is performed using mixed models and the tests are two-sided, with a type I error set at α=0.05. Considering the poor efficacy of available drugs in chemotherapy-induced neuropathic pain, dextromethorphan may be a valuable therapeutic option. Pharmacogenetics may provide predictive factors of dextromethorphan response in patients suffering from breast cancer. Copyright © 2015 Elsevier Inc. All rights reserved.

  5. Markers of achievement for assessing and monitoring gender equity in translational research organisations: a rationale and study protocol

    Science.gov (United States)

    Edmunds, Laurel D; Pololi, Linda H; Greenhalgh, Trisha; Kiparoglou, Vasiliki; Henderson, Lorna R; Williamson, Catherine; Grant, Jonathan; Lord, Graham M; Channon, Keith M; Lechler, Robert I; Buchan, Alastair M

    2016-01-01

    Introduction Translational research organisations (TROs) are a core component of the UK's expanding research base. Equity of career opportunity is key to ensuring a diverse and internationally competitive workforce. The UK now requires TROs to demonstrate how they are supporting gender equity. Yet, the evidence base for documenting such efforts is sparse. This study is designed to inform the acceleration of women's advancement and leadership in two of the UK's leading TROs—the National Institute for Health Research (NIHR) Biomedical Research Centres (BRCs) in Oxford and London—through the development, application and dissemination of a conceptual framework and measurement tool. Methods and analysis A cross-sectional retrospective evaluation. A conceptual framework with markers of achievement and corresponding candidate metrics has been specifically designed for this study based on an adapted balanced scorecard approach. It will be refined with an online stakeholder consultation and semistructured interviews to test the face validity and explore practices and mechanisms that influence gender equity in the given settings. Data will be collected via the relevant administrative databases. A comparison of two funding periods (2007–2012 and 2012–2017) will be carried out. Ethics and dissemination The University of Oxford Clinical Trials and Research Governance Team and the Research and Development Governance Team of Guy's and St Thomas’ National Health Service (NHS) Foundation Trust reviewed the study and deemed it exempt from full ethics review. The results of the study will be used to inform prospective planning and monitoring within the participating NIHR BRCs with a view to accelerating women's advancement and leadership. Both the results of the study and its methodology will be further disseminated to academics and practitioners through the networks of collaborating TROs, relevant conferences and articles in peer-reviewed journals. PMID:26743702

  6. Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study

    Directory of Open Access Journals (Sweden)

    Chaudhry Shazia H

    2009-07-01

    Full Text Available Abstract Background Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities – rather than individual themselves – are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main objectives of this research are to: (1 identify ethical issues arising in cluster trials and learn how they are currently being addressed; (2 understand how ethics reviews of cluster trials are carried out in different countries (Canada, the USA and the UK; (3 elicit the views and experiences of trial participants and cluster representatives; (4 develop well-grounded guidelines for the ethical conduct and review of cluster trials by conducting an extensive ethical analysis and organizing a consensus process; (5 disseminate the guidelines to researchers, research ethics boards (REBs, journal editors, and research funders. Methods We will use a mixed-methods (qualitative and quantitative approach incorporating both empirical and conceptual work. Empirical work will include a systematic review of a random sample of published trials, a survey and in-depth interviews with trialists, a survey of REBs, and in-depth interviews and focus group discussions with trial participants and gatekeepers. The empirical work will inform the concurrent ethical analysis which will lead to a guidance document laying out principles, policy options, and rationale for proposed guidelines. An

  7. Rationale, design, and implementation protocol of an electronic health record integrated clinical prediction rule (iCPR randomized trial in primary care

    Directory of Open Access Journals (Sweden)

    Wisnivesky Juan

    2011-09-01

    Full Text Available Abstract Background Clinical prediction rules (CPRs represent well-validated but underutilized evidence-based medicine tools at the point-of-care. To date, an inability to integrate these rules into an electronic health record (EHR has been a major limitation and we are not aware of a study demonstrating the use of CPR's in an ambulatory EHR setting. The integrated clinical prediction rule (iCPR trial integrates two CPR's in an EHR and assesses both the usability and the effect on evidence-based practice in the primary care setting. Methods A multi-disciplinary design team was assembled to develop a prototype iCPR for validated streptococcal pharyngitis and bacterial pneumonia CPRs. The iCPR tool was built as an active Clinical Decision Support (CDS tool that can be triggered by user action during typical workflow. Using the EHR CDS toolkit, the iCPR risk score calculator was linked to tailored ordered sets, documentation, and patient instructions. The team subsequently conducted two levels of 'real world' usability testing with eight providers per group. Usability data were used to refine and create a production tool. Participating primary care providers (n = 149 were randomized and intervention providers were trained in the use of the new iCPR tool. Rates of iCPR tool triggering in the intervention and control (simulated groups are monitored and subsequent use of the various components of the iCPR tool among intervention encounters is also tracked. The primary outcome is the difference in antibiotic prescribing rates (strep and pneumonia iCPR's encounters and chest x-rays (pneumonia iCPR only between intervention and control providers. Discussion Using iterative usability testing and development paired with provider training, the iCPR CDS tool leverages user-centered design principles to overcome pervasive underutilization of EBM and support evidence-based practice at the point-of-care. The ongoing trial will determine if this collaborative

  8. Risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients: design and rationale of the ROADMAP clinical trial.

    Science.gov (United States)

    Rogers, Joseph G; Boyle, Andrew J; O'Connell, John B; Horstmanshof, Douglas A; Haas, Donald C; Slaughter, Mark S; Park, Soon J; Farrar, David J; Starling, Randall C

    2015-02-01

    Mechanical circulatory support is now a proven therapy for the treatment of patients with advanced heart failure and cardiogenic shock. The role for this therapy in patients with less severe heart failure is unknown. The objective of this study is to examine the impact of mechanically assisted circulation using the HeartMate II left ventricular assist device in patients who meet current US Food and Drug Administration-defined criteria for treatment but are not yet receiving intravenous inotropic therapy. This is a prospective, nonrandomized clinical trial of 200 patients treated with either optimal medical management or a mechanical circulatory support device. This trial will be the first prospective clinical evaluation comparing outcomes of patients with advanced ambulatory heart failure treated with either ongoing medical therapy or a left ventricular assist device. It is anticipated to provide novel insights regarding relative outcomes with each treatment and an understanding of patient and provider acceptance of the ventricular assist device therapy. This trial will also provide information regarding the risk of events in "stable" patients with advanced heart failure and guidance for the optimal timing of left ventricular assist device therapy. Copyright © 2014 Elsevier Inc. All rights reserved.

  9. DOE LLW classification rationale

    International Nuclear Information System (INIS)

    Flores, A.Y.

    1991-01-01

    This report was about the rationale which the US Department of Energy had with low-level radioactive waste (LLW) classification. It is based on the Nuclear Regulatory Commission's classification system. DOE site operators met to review the qualifications and characteristics of the classification systems. They evaluated performance objectives, developed waste classification tables, and compiled dose limits on the waste. A goal of the LLW classification system was to allow each disposal site the freedom to develop limits to radionuclide inventories and concentrations according to its own site-specific characteristics. This goal was achieved with the adoption of a performance objectives system based on a performance assessment, with site-specific environmental conditions and engineered disposal systems

  10. Studying variability in human brain aging in a population-based German cohort – Rationale and design of 1000BRAINS

    Directory of Open Access Journals (Sweden)

    Svenja eCaspers

    2014-07-01

    Full Text Available The ongoing 1000 brains study (1000BRAINS is an epidemiological and neuroscientific investigation of structural and functional variability in the human brain during aging. The two recruitment sources are the 10-year follow-up cohort of the German Heinz Nixdorf Recall (HNR Study, and the HNR MultiGeneration Study cohort, which comprises spouses and offspring of HNR subjects. The HNR is a longitudinal epidemiological investigation of cardiovascular risk factors, with a comprehensive collection of clinical, laboratory, socioeconomic, and environmental data from population-based subjects aged 45-75 years on inclusion. HNR subjects underwent detailed assessments in 2000, 2006, and 2011, and completed annual postal questionnaires on health status. 1000BRAINS accesses these HNR data and applies a separate protocol comprising: neuropsychological tests of attention, memory, executive functions & language; examination of motor skills; ratings of personality, life quality, mood & daily activities; analysis of laboratory and genetic data; and state-of-the-art magnetic resonance imaging (MRI, 3 Tesla of the brain. The latter includes (i 3D-T1- and 3D-T2-weighted scans for structural analyses and myelin mapping; (ii three diffusion imaging sequences optimized for diffusion tensor imaging, high-angular resolution diffusion imaging for detailed fibre tracking and for diffusion kurtosis imaging; (iii resting-state and task-based functional MRI; and (iv fluid-attenuated inversion recovery and MR angiography for the detection of vascular lesions and the mapping of white matter lesions. The unique design of 1000BRAINS allows: (i comprehensive investigation of various influences including genetics, environment and health status on variability in brain structure and function during aging; and (ii identification of the impact of selected influencing factors on specific cognitive subsystems and their anatomical correlates.

  11. Working Inside for Smoking Elimination (Project W.I.S.E. study design and rationale to prevent return to smoking after release from a smoke free prison

    Directory of Open Access Journals (Sweden)

    Mello Jennifer

    2011-10-01

    Full Text Available Abstract Background Incarcerated individuals suffer disproportionately from the health effects of tobacco smoking due to the high smoking prevalence in this population. In addition there is an over-representation of ethnic and racial minorities, impoverished individuals, and those with mental health and drug addictions in prisons. Increasingly, prisons across the U.S. are becoming smoke free. However, relapse to smoking is common upon release from prison, approaching 90% within a few weeks. No evidence based treatments currently exist to assist individuals to remain abstinent after a period of prolonged, forced abstinence. Methods/Design This paper describes the design and rationale of a randomized clinical trial to enhance smoking abstinence rates among individuals following release from a tobacco free prison. The intervention is six weekly sessions of motivational interviewing and cognitive behavioral therapy initiated approximately six weeks prior to release from prison. The control group views six time matched videos weekly starting about six weeks prior to release. Assessments take place in-person 3 weeks after release and then for non-smokers every 3 months up to 12 months. Smoking status is confirmed by urine cotinine. Discussion Effective interventions are greatly needed to assist these individuals to remain smoke free and reduce health disparities among this socially and economically challenged group. Trial Registration NCT01122589

  12. Teacher Grading Decisions: Influences, Rationale, and Practices

    Science.gov (United States)

    Kunnath, Joshua P.

    2017-01-01

    This mixed-methods study applied a decision-making theoretical framework to an investigation of teacher grading in a large urban school district in California. A sample of 251 high school teachers of core subjects were surveyed, and 15 teachers participated in four focus group interviews in order provide data on the influences, rationale, and…

  13. Age-related macular degeneration in a randomized controlled trial of low-dose aspirin: Rationale and study design of the ASPREE-AMD study

    Directory of Open Access Journals (Sweden)

    Liubov Robman

    2017-06-01

    Conclusion: The study findings will be of significant clinical and public interest due to a potential to identify a possible low cost therapy for preventing AMD worldwide and to determine risk/benefit balance of the aspirin usage by the AMD-affected elderly. The ASPREE-AMD study provides a unique opportunity to determine the effect of aspirin on AMD incidence and progression, by adding retinal imaging to an ongoing, large-scale primary prevention randomized clinical trial.

  14. Methods and rationale used in a matched cohort study of the incidence of new primary cancers following prostate cancer

    Directory of Open Access Journals (Sweden)

    Cronin-Fenton DP

    2013-10-01

    Full Text Available Deirdre P Cronin-Fenton,1 Sussie Antonsen,1 Karynsa Cetin,2 John Acquavella,2 Andre Daniels,3 Timothy L Lash1,4 1Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 2Center for Observational Research, Amgen Incorporated, Thousand Oaks, CA, USA; 3Global Regulatory Affairs and Safety, Amgen Incorporated, Thousand Oaks, CA, USA; 4Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA Objectives: We describe several methodological issues that were addressed in conducting a Danish population-based matched cohort study comparing rates of new primary cancers (NPCs in men with and without prostate cancer (PC. Methods: We matched 30,220 men with PC to 151,100 men without PC (comparators on age (±2 years and PC diagnosis/index date. We focused on several methodological issues: 1 to address survival differences between the cohorts we compared rates with and without censoring comparators on the date their matched PC patient died or was censored; 2 to address diagnostic bias, we excluded men with a history of cancer from the comparator cohort; 3 to address prostate cancer immunity, we graphed the hazard of NPC in both cohorts, with and without prostate cancer as an outcome; 4 we used empirical Bayes methods to explore the effect of adjusting for multiple comparisons. Results: After 18 months of follow-up, cumulative person-time was lower in the PC than comparator cohort due to higher mortality among PC patients. Terminating person-time in comparators at the matched PC patient's death or loss to follow-up resulted in comparable person-time up to 30 months of follow-up and lower person-time among comparators thereafter. The hazard of NPC was lower among men with PC than comparators throughout follow-up. There was little difference in rates beyond the first four years of follow-up after removing PC as an outcome. Empirical Bayes adjustment for multiple comparisons had little effect on the

  15. Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST): rationale, design, and protocol of a pilot randomized clinical trial assessing the Wii gaming system.

    Science.gov (United States)

    Saposnik, G; Mamdani, M; Bayley, M; Thorpe, K E; Hall, J; Cohen, L G; Teasell, R

    2010-02-01

    Evidence suggests that increasing intensity of rehabilitation results in better motor recovery. Limited evidence is available on the effectiveness of an interactive virtual reality gaming system for stroke rehabilitation. EVREST was designed to evaluate feasibility, safety and efficacy of using the Nintendo Wii gaming virtual reality (VRWii) technology to improve arm recovery in stroke patients. Pilot randomized study comparing, VRWii versus recreational therapy (RT) in patients receiving standard rehabilitation within six months of stroke with a motor deficit of > or =3 on the Chedoke-McMaster Scale (arm). In this study we expect to randomize 20 patients. All participants (age 18-85) will receive customary rehabilitative treatment consistent of a standardized protocol (eight sessions, 60 min each, over a two-week period). The primary feasibility outcome is the total time receiving the intervention. The primary safety outcome is the proportion of patients experiencing intervention-related adverse events during the study period. Efficacy, a secondary outcome measure, will be measured by the Wolf Motor Function Test, Box and Block Test, and Stroke Impact Scale at the four-week follow-up visit. From November, 2008 to September, 2009 21 patients were randomized to VRWii or RT. Mean age, 61 (range 41-83) years. Mean time from stroke onset 25 (range 10-56) days. EVREST is the first randomized parallel controlled trial assessing the feasibility, safety, and efficacy of virtual reality using Wii gaming technology in stroke rehabilitation. The results of this study will serve as the basis for a larger multicentre trial. ClinicalTrials.gov registration# NTC692523.

  16. Radiosensitizers: rationale and potential

    International Nuclear Information System (INIS)

    Brown, J.M.

    1981-01-01

    This paper briefly reviews agents that are capable of sensitizing hypoxic cells to radiation and chemotherapeutic agents. The first part is a synopsis of the development of hypoxic radiosensitizers, which concludes that misonidazole can be effective against human tumors. Unfortunately, neurotoxicity limits its effectiveness in humans because the dose that can be given in conjunction with daily fractionated radiation is five to ten times lower than is required for full radiosensitization of the hypoxic cells. The second part covers our recent efforts to develop a drug that does not produce such limiting neurotoxicity. The primary rationale of our program was to synthesize a drug with a short plasma half-life that was too hydrophilic to cross the blood-brain barrier but was able to penetrate tumors and radiosensitize hypoxic cells. From this program, a new drug, SR-2508, has been found that is as efficient as misonidazole in its radiosensitizing ability, but is four to ten times less toxic. Finally, the potential of radiosensitizers not only as agents that can sensitize tumor cells to radiation, but also as agents that can specifically sensitize tumors to chemotherapeutic agents, is discussed. In addition, these drugs may be potential cytotoxic agents that produce toxicity only in solid tumors

  17. Clinical profiling of BCL-2 family members in the setting of BRAF inhibition offers a rationale for targeting de novo resistance using BH3 mimetics.

    Directory of Open Access Journals (Sweden)

    Dennie T Frederick

    Full Text Available While response rates to BRAF inhibitiors (BRAFi are high, disease progression emerges quickly. One strategy to delay the onset of resistance is to target anti-apoptotic proteins such as BCL-2, known to be associated with a poor prognosis. We analyzed BCL-2 family member expression levels of 34 samples from 17 patients collected before and 10 to 14 days after treatment initiation with either vemurafenib or dabrafenib/trametinib combination. The observed changes in mRNA and protein levels with BRAFi treatment led us to hypothesize that combining BRAFi with a BCL-2 inhibitor (the BH3-mimetic navitoclax would improve outcome. We tested this hypothesis in cell lines and in mice. Pretreatment mRNA levels of BCL-2 negatively correlated with maximal tumor regression. Early increases in mRNA levels were seen in BIM, BCL-XL, BID and BCL2-W, as were decreases in MCL-1 and BCL2A. No significant changes were observed with BCL-2. Using reverse phase protein array (RPPA, significant increases in protein levels were found in BIM and BID. No changes in mRNA or protein correlated with response. Concurrent BRAF (PLX4720 and BCL2 (navitoclax inhibition synergistically reduced viability in BRAF mutant cell lines and correlated with down-modulation of MCL-1 and BIM induction after PLX4720 treatment. In xenograft models, navitoclax enhanced the efficacy of PLX4720. The combination of a selective BRAF inhibitor with a BH3-mimetic promises to be an important therapeutic strategy capable of enhancing the clinical efficacy of BRAF inhibition in many patients that might otherwise succumb quickly to de novo resistance. Trial registrations: ClinicalTrials.gov NCT01006980; ClinicalTrials.gov NCT01107418; ClinicalTrials.gov NCT01264380; ClinicalTrials.gov NCT01248936; ClinicalTrials.gov NCT00949702; ClinicalTrials.gov NCT01072175.

  18. Prognostic value of site SYNTAX score and rationale for combining anatomic and clinical factors in decision making: Insights from the SYNTAX trial

    NARCIS (Netherlands)

    Y.-J. Zhang (Yao-Jun); A. Iqbal (Anwarul); C.A.M. Campos (Carlos); D. van Klaveren (David); C.V. Bourantas (Christos); K.D. Dawkins (Keith); A. Banning (Adrian); J. Escaned (Javier); T. de Vries (Ton); M-A.M. Morel (Marie-Angèle); V. Farooq (Vasim); Y. Onuma (Yoshinobu); H.M. Garcia-Garcia (Hector); G.W. Stone (Gregg); E.W. Steyerberg (Ewout); F.W. Mohr (Friedrich); P.W.J.C. Serruys (Patrick)

    2014-01-01

    textabstractBackground The results of SYNTAX trial have been reported based on "corelab" calculated SS (cSS). It has been shown that reproducibility of SS is better among the core laboratory technicians than interventional cardiologists. Thus, the prognostic value and clinical implication of the

  19. Considerations in the rationale, design and methods of the Strategic Timing of AntiRetroviral Treatment (START) study

    DEFF Research Database (Denmark)

    Babiker, Abdel G; Emery, Sean; Fätkenheuer, Gerd

    2013-01-01

    Untreated human immunodeficiency virus (HIV) infection is characterized by progressive depletion of CD4+ T lymphocyte (CD4) count leading to the development of opportunistic diseases (acquired immunodeficiency syndrome (AIDS)), and more recent data suggest that HIV is also associated with an incr...... is not feasible with currently available drugs. The optimal time to start ART for asymptomatic HIV infection is controversial and remains one of the key unanswered questions in the clinical management of HIV-infected individuals.......Untreated human immunodeficiency virus (HIV) infection is characterized by progressive depletion of CD4+ T lymphocyte (CD4) count leading to the development of opportunistic diseases (acquired immunodeficiency syndrome (AIDS)), and more recent data suggest that HIV is also associated...

  20. Mediterranean studies of cardiovascular disease and hyperglycemia: analytical modeling of population socio-economic transitions (MedCHAMPS)--rationale and methods.

    Science.gov (United States)

    Maziak, Wasim; Critchley, Julia; Zaman, Shahaduz; Unwin, Nigel; Capewell, Simon; Bennett, Kathleen; Unal, Belgin; Husseini, Abdullatif; Romdhane, Habiba Ben; Phillimore, Peter

    2013-08-01

    In response to the escalating epidemic of cardiovascular disease (CVD) in the Mediterranean Region (MR), an international collaboration aiming at understanding the burden of CVD and evaluating cost-effective strategies to combat it was recently established. This paper describes the rationale and methods of the project MedCHAMPS to disseminate this successful experience. The framework of MedCHAMPS is exceptional in combining multiple disciplines (e.g. epidemiology, anthropology, economics), countries [Turkey, Syria, occupied Palestinian territory (oPt), Tunisia, UK, Ireland], research methods (situational and policy analysis, quantitative and qualitative studies, statistical modeling), and involving local stakeholders at all levels to assess trends of CVD/diabetes in the society and attributes of the local health care systems to provide optimal policy recommendations to reduce the burden of CVD/diabetes. MedCHAMPS provides policy makers in the MR and beyond needed guidance about the burden of CVD, and best cost-effective ways to combat it. Our approach of building developed-developing countries collaboration also provides a roadmap for other researchers seeking to build research base into CVD epidemiology and prevention in developing countries.

  1. A randomised trial of the Flinders Program to improve patient self-management competencies in a range of chronic conditions: study rationale and protocol

    Directory of Open Access Journals (Sweden)

    Malcolm W. Battersby

    2010-03-01

    Full Text Available BackgroundSupporting self management is seen as an important healthservice strategy in dealing with the large and increasing healthburden of chronic conditions. Several types of selfmanagementprograms are available. Evidence to datesuggests that disease-specific and lay-led self managementprograms provide only part of the support needed forimproved outcomes. The Flinders Program is promising as ageneric self management intervention, which can becombined with targeted disease-specific and lay-ledinterventions, but it has yet to be evaluated for a range ofchronic conditions using a rigorous controlled trial design. Thispaper gives the rationale for a randomised controlled trial andprocess evaluation of the Flinders Program of chroniccondition self-management in community practice, and detailsand justifies the design of such a study.MethodThe design for a randomised trial and associated processevaluation, suited to evaluation of a complex and behaviouralintervention as it is applied in actual practice, is presented andjustified.ConclusionA randomised trial of the Flinders Program is required and afunctional design is presented. Results from this trial,currently underway, will test the effectiveness of the FlindersProgram in improving patient competencies in selfmanagementof chronic conditions in practice conditions.A process evaluation alongside the trial will exploresystem, provider and patient factors associated withgreater and lesser Program effectiveness.

  2. A community-based obesity prevention program for minority children: rationale and study design for Hip-Hop to Health Jr.

    Science.gov (United States)

    Fitzgibbon, Marian L; Stolley, Melinda R; Dyer, Alan R; VanHorn, Linda; KauferChristoffel, Katherine

    2002-02-01

    BACKGROUND; The increasing prevalence of overweight among children in the United States presents a national health priority. Higher rates of overweight/obesity among minority women place their children at increased risk. Although increased rates of overweight are observed in 4- to 5-year-old children, they are not observed in 2- to 3-year-old children. Therefore, early prevention efforts incorporating families are critical. The primary aim of Hip-Hop to Health Jr. is to alter the trajectory toward overweight/obesity among preschool African-American and Latino children. This 5-year randomized intervention is conducted in 24 Head Start programs, where each site is randomized to either a 14-week dietary/physical activity intervention or a general health intervention. This paper presents the rationale and design of the study. Efficacy of the intervention will be determined by weight change for the children and parent/caretaker. Secondary measures include reductions in dietary fat and increases in fiber, fruit/vegetable intake, and physical activity. Baseline data will be presented in future papers. The problem of overweight/obesity is epidemic in the United States. Behaviors related to diet and physical activity are established early in life and modeled by family members. Early intervention efforts addressing the child and family are needed to prevent obesity later in life. This paper describes a comprehensive, family-oriented obesity prevention program for minority preschool children. Copyright 2002 American Health Foundation and Elsevier Science (USA).

  3. Prosthetic valves in adult patients with congenital heart disease : Rationale and design of the Dutch PROSTAVA study

    NARCIS (Netherlands)

    Freling, H. G.; van Slooten, Y. J.; van Melle, J. P.; Mulder, B. J. M.; van Dijk, A. P. J.; Hillege, H. L.; Post, M. C.; Sieswerda, G. Tj; Jongbloed, M. R. M.; Willems, T. P.; Pieper, P. G.

    2012-01-01

    Data on long-term complications in adult patients with congenital heart disease (ACHD) and a prosthetic valve are scarce. Moreover, the influence of prosthetic valves on quality of life (QoL) and functional outcome in ACHD patients with prosthetic valves has not been studied. The primary objective

  4. The rationale and design of the Micra Transcatheter Pacing Study: safety and efficacy of a novel miniaturized pacemaker.

    Science.gov (United States)

    Ritter, Philippe; Duray, Gabor Z; Zhang, Shu; Narasimhan, Calambur; Soejima, Kyoko; Omar, Razali; Laager, Verla; Stromberg, Kurt; Williams, Eric; Reynolds, Dwight

    2015-05-01

    Recent advances in miniaturization technologies and battery chemistries have made it possible to develop a pacemaker small enough to implant within the heart while still aiming to provide similar battery longevity to conventional pacemakers. The Micra Transcatheter Pacing System is a miniaturized single-chamber pacemaker system that is delivered via catheter through the femoral vein. The pacemaker is implanted directly inside the right ventricle of the heart, eliminating the need for a device pocket and insertion of a pacing lead, thereby potentially avoiding some of the complications associated with traditional pacing systems. The Micra Transcatheter Pacing Study is currently undergoing evaluation in a prospective, multi-site, single-arm study. Approximately 720 patients will be implanted at up to 70 centres around the world. The study is designed to have a continuously growing body of evidence and data analyses are planned at various time points. The primary safety and efficacy objectives at 6-month post-implant are to demonstrate that (i) the percentage of Micra patients free from major complications related to the Micra system or implant procedure is significantly higher than 83% and (ii) the percentage of Micra patients with both low and stable thresholds is significantly higher than 80%. The safety performance benchmark is based on a reference dataset of 977 subjects from 6 recent pacemaker studies. The Micra Transcatheter Pacing Study will assess the safety and efficacy of a miniaturized, totally endocardial pacemaker in patients with an indication for implantation of a single-chamber ventricular pacemaker. NCT02004873. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  5. Research on Emissions, Air quality, Climate, and Cooking Technologies in Northern Ghana (REACCTING): study rationale and protocol.

    Science.gov (United States)

    Dickinson, Katherine L; Kanyomse, Ernest; Piedrahita, Ricardo; Coffey, Evan; Rivera, Isaac J; Adoctor, James; Alirigia, Rex; Muvandimwe, Didier; Dove, MacKenzie; Dukic, Vanja; Hayden, Mary H; Diaz-Sanchez, David; Abisiba, Adoctor Victor; Anaseba, Dominic; Hagar, Yolanda; Masson, Nicholas; Monaghan, Andrew; Titiati, Atsu; Steinhoff, Daniel F; Hsu, Yueh-Ya; Kaspar, Rachael; Brooks, Bre'Anna; Hodgson, Abraham; Hannigan, Michael; Oduro, Abraham Rexford; Wiedinmyer, Christine

    2015-02-12

    Cooking over open fires using solid fuels is both common practice throughout much of the world and widely recognized to contribute to human health, environmental, and social problems. The public health burden of household air pollution includes an estimated four million premature deaths each year. To be effective and generate useful insight into potential solutions, cookstove intervention studies must select cooking technologies that are appropriate for local socioeconomic conditions and cooking culture, and include interdisciplinary measurement strategies along a continuum of outcomes. REACCTING (Research on Emissions, Air quality, Climate, and Cooking Technologies in Northern Ghana) is an ongoing interdisciplinary randomized cookstove intervention study in the Kassena-Nankana District of Northern Ghana. The study tests two types of biomass burning stoves that have the potential to meet local cooking needs and represent different "rungs" in the cookstove technology ladder: a locally-made low-tech rocket stove and the imported, highly efficient Philips gasifier stove. Intervention households were randomized into four different groups, three of which received different combinations of two improved stoves, while the fourth group serves as a control for the duration of the study. Diverse measurements assess different points along the causal chain linking the intervention to final outcomes of interest. We assess stove use and cooking behavior, cooking emissions, household air pollution and personal exposure, health burden, and local to regional air quality. Integrated analysis and modeling will tackle a range of interdisciplinary science questions, including examining ambient exposures among the regional population, assessing how those exposures might change with different technologies and behaviors, and estimating the comparative impact of local behavior and technological changes versus regional climate variability and change on local air quality and health outcomes

  6. Rationale and design of the East-West late lumen loss study: Comparison of late lumen loss between Eastern and Western drug-eluting stent study cohorts.

    Science.gov (United States)

    Harrison, Robert W; Radhakrishnan, Vaishnavi; Lam, Peter S; Allocco, Dominic J; Brar, Sandeep; Fahy, Martin; Fisher, Rebecca; Ikeno, Fumiaki; Généreux, Philippe; Kimura, Takeshi; Liu, Minglei; Lye, Weng Kit; Mintz, Gary S; Nagai, Hirofumi; Suzuki, Yuka; White, Roseann; Allen, John C; Krucoff, Mitchell W

    2016-12-01

    The contemporary evaluation of novel drug-eluting stents (DES) includes mechanistic observations that characterize postdeployment stent behavior. Quantification of late lumen loss due to neointimal hyperplasia 8-13 months after stent implantation, via quantitative coronary angiography (QCA), constitutes such an observation and is required by most regulatory authorities. Late lumen loss, as determined by QCA, has been validated as a surrogate for clinical endpoints such as target vessel revascularization. The mechanistic response to DES has not been directly compared across predominantly Asian or Western populations, whereas understanding their comparability across geographic populations could enhance global DES evaluation. The East-West late lumen loss study is designed to demonstrate whether the residual differences in late lumen loss, as assessed by QCA, is different between Eastern and Western DES recipients from studies with protocol angiography at 8-13 months of follow-up. Data from independent core laboratories that have characterized angiographic late lumen loss in DES clinical trials with protocol follow-up angiography will be compiled and dichotomized into Eastern and Western populations. A prospectively developed propensity score model incorporating clinical and anatomic variables affecting late lumen loss will be used to adjust comparisons of QCA measurements. Documentation of whether there are clinically meaningful differences in mechanistic response to DES implantation across genetically unique geographies could facilitate both the quality and efficiency of global device evaluation requiring invasive follow-up for novel stent designs. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Rationale and design of MinerAlocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF)

    DEFF Research Database (Denmark)

    Pitt, Bertram; Anker, Stefan D; Böhm, Michael

    2015-01-01

    dysfunction. METHODS AND RESULTS: The MinerAlocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF; NCT01807221) is a multicentre, randomized, double-blind, active-comparator-controlled, six-parallel-group, phase 2b dose-finding study. In total, 1060 patients with HFrEF and concomitant type...... 2 diabetes mellitus and/or chronic kidney disease (CKD) will be randomized within 7 days of emergency presentation to hospital for worsening chronic HF to receive finerenone (one of five doses in the range 2.5-20.0 mg once daily) or eplerenone (25 mg every second day to 50 mg once daily for 90 days...

  8. HEALTHY study rationale, design and methods: moderating risk of type 2 diabetes in multi-ethnic middle school students.

    Science.gov (United States)

    Hirst, Kathryn; Baranowski, Tom; DeBar, Lynn; Foster, Gary D; Kaufman, Francine; Kennel, Phyllis; Linder, Barbara; Schneider, Margaret; Venditti, Elizabeth M; Yin, Zenong

    2009-08-01

    The HEALTHY primary prevention trial was designed and implemented in response to the growing numbers of children and adolescents being diagnosed with type 2 diabetes. The objective was to moderate risk factors for type 2 diabetes. Modifiable risk factors measured were indicators of adiposity and glycemic dysregulation: body mass index > or =85th percentile, fasting glucose > or =5.55 mmol l(-1) (100 mg per 100 ml) and fasting insulin > or =180 pmol l(-1) (30 microU ml(-1)). A series of pilot studies established the feasibility of performing data collection procedures and tested the development of an intervention consisting of four integrated components: (1) changes in the quantity and nutritional quality of food and beverage offerings throughout the total school food environment; (2) physical education class lesson plans and accompanying equipment to increase both participation and number of minutes spent in moderate-to-vigorous physical activity; (3) brief classroom activities and family outreach vehicles to increase knowledge, enhance decision-making skills and support and reinforce youth in accomplishing goals; and (4) communications and social marketing strategies to enhance and promote changes through messages, images, events and activities. Expert study staff provided training, assistance, materials and guidance for school faculty and staff to implement the intervention components. A cohort of students were enrolled in sixth grade and followed to end of eighth grade. They attended a health screening data collection at baseline and end of study that involved measurement of height, weight, blood pressure, waist circumference and a fasting blood draw. Height and weight were also collected at the end of the seventh grade. The study was conducted in 42 middle schools, six at each of seven locations across the country, with 21 schools randomized to receive the intervention and 21 to act as controls (data collection activities only). Middle school was the unit of

  9. Searching for new biomarkers in ovarian cancer patients: Rationale and design of a retrospective study under the Mermaid III project

    Directory of Open Access Journals (Sweden)

    Julie L. Hentze

    2017-12-01

    A thorough investigation of biomarkers in ovarian cancer, including large numbers of different markers, has never been done before. Besides from improving diagnosis and treatment, other outcomes could be markers for screening, knowledge of the molecular aspects of cancer and the discovery of new drugs. Moreover, biomarkers are a prerequisite for the development of precision medicine. This study will attack the ovarian cancer problem from several angles, thereby increasing the chance of successfully contributing to saving lives.

  10. Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT: a randomized controlled study

    Directory of Open Access Journals (Sweden)

    Nguyen Phuong H

    2012-10-01

    Full Text Available Abstract Background Low birth weight and maternal anemia remain intractable problems in many developing countries. The adequacy of the current strategy of providing iron-folic acid (IFA supplements only during pregnancy has been questioned given many women enter pregnancy with poor iron stores, the substantial micronutrient demand by maternal and fetal tissues, and programmatic issues related to timing and coverage of prenatal care. Weekly IFA supplementation for women of reproductive age (WRA improves iron status and reduces the burden of anemia in the short term, but few studies have evaluated subsequent pregnancy and birth outcomes. The Preconcept trial aims to determine whether pre-pregnancy weekly IFA or multiple micronutrient (MM supplementation will improve birth outcomes and maternal and infant iron status compared to the current practice of prenatal IFA supplementation only. This paper provides an overview of study design, methodology and sample characteristics from baseline survey data and key lessons learned. Methods/design We have recruited 5011 WRA in a double-blind stratified randomized controlled trial in rural Vietnam and randomly assigned them to receive weekly supplements containing either: 1 2800 μg folic acid 2 60 mg iron and 2800 μg folic acid or 3 MM. Women who become pregnant receive daily IFA, and are being followed through pregnancy, delivery, and up to three months post-partum. Study outcomes include birth outcomes and maternal and infant iron status. Data are being collected on household characteristics, maternal diet and mental health, anthropometry, infant feeding practices, morbidity and compliance. Discussion The study is timely and responds to the WHO Global Expert Consultation which identified the need to evaluate the long term benefits of weekly IFA and MM supplementation in WRA. Findings will generate new information to help guide policy and programs designed to reduce the burden of anemia in women and

  11. Early markers of airways inflammation and occupational asthma: Rationale, study design and follow-up rates among bakery, pastry and hairdressing apprentices

    Directory of Open Access Journals (Sweden)

    Hannhart Bernard

    2009-04-01

    Full Text Available Abstract Background Occupational asthma is a common type of asthma caused by a specific agent in the workplace. The basic alteration of occupational asthma is airways inflammation. Although most patients with occupational asthma are mature adults, there is evidence that airways inflammation starts soon after inception of exposure, including during apprenticeship. Airways hyper responsiveness to methacholine is a valid surrogate marker of airways inflammation, which has proved useful in occupational epidemiology. But it is time-consuming, requires active subject's cooperation and is not readily feasible. Other non-invasive and potentially more useful tests include the forced oscillation technique, measurement of fraction exhaled nitric oxide, and eosinophils count in nasal lavage fluid. Methods and design This study aims to investigate early development of airways inflammation and asthma-like symptoms in apprentice bakers, pastry-makers and hairdressers, three populations at risk of occupational asthma whose work-related exposures involve agents of different nature. The objectives are to (i examine the performance of the non-invasive tests cited above in detecting early airways inflammation that might eventually develop into occupational asthma; and (ii evaluate whether, and how, constitutional (e.g. atopy and behavioural (e.g. smoking risk factors for occupational asthma modulate the effects of allergenic and/or irritative substances involved in these occupations. This paper presents the study rationale and detailed protocol. Discussion Among 441 volunteers included at the first visit, 354 attended the fourth one. Drop outs were investigated and showed unrelated to the study outcome. Sample size and follow-up participation rates suggest that the data collected in this study will allow it to meet its objectives.

  12. Early markers of airways inflammation and occupational asthma: rationale, study design and follow-up rates among bakery, pastry and hairdressing apprentices.

    Science.gov (United States)

    Tossa, Paul; Bohadana, Abraham; Demange, Valérie; Wild, Pascal; Michaely, Jean-Pierre; Hannhart, Bernard; Paris, Christophe; Zmirou-Navier, Denis

    2009-04-23

    Occupational asthma is a common type of asthma caused by a specific agent in the workplace. The basic alteration of occupational asthma is airways inflammation. Although most patients with occupational asthma are mature adults, there is evidence that airways inflammation starts soon after inception of exposure, including during apprenticeship. Airways hyper responsiveness to methacholine is a valid surrogate marker of airways inflammation, which has proved useful in occupational epidemiology. But it is time-consuming, requires active subject's cooperation and is not readily feasible. Other non-invasive and potentially more useful tests include the forced oscillation technique, measurement of fraction exhaled nitric oxide, and eosinophils count in nasal lavage fluid. This study aims to investigate early development of airways inflammation and asthma-like symptoms in apprentice bakers, pastry-makers and hairdressers, three populations at risk of occupational asthma whose work-related exposures involve agents of different nature. The objectives are to (i) examine the performance of the non-invasive tests cited above in detecting early airways inflammation that might eventually develop into occupational asthma; and (ii) evaluate whether, and how, constitutional (e.g. atopy) and behavioural (e.g. smoking) risk factors for occupational asthma modulate the effects of allergenic and/or irritative substances involved in these occupations. This paper presents the study rationale and detailed protocol. Among 441 volunteers included at the first visit, 354 attended the fourth one. Drop outs were investigated and showed unrelated to the study outcome. Sample size and follow-up participation rates suggest that the data collected in this study will allow it to meet its objectives.

  13. The effects of intermittent calorie restriction on metabolic health: Rationale and study design of the HELENA Trial.

    Science.gov (United States)

    Schübel, Ruth; Graf, Mirja E; Nattenmüller, Johanna; Nabers, Diana; Sookthai, Disorn; Gruner, Laura F; Johnson, Theron; Schlett, Christopher L; von Stackelberg, Oyunbileg; Kirsten, Romy; Habermann, Nina; Kratz, Mario; Kauczor, Hans-Ulrich; Ulrich, Cornelia M; Kaaks, Rudolf; Kühn, Tilman

    2016-11-01

    Mechanistic studies suggest benefits of intermittent calorie restriction (ICR) in chronic disease prevention that may exceed those of continuous calorie restriction (CCR), even at equal net calorie intake. Despite promising results from first trials, it remains largely unknown whether ICR-induced metabolic alterations reported from experimental studies can also be observed in humans, and whether ICR diets are practicable and effective in real life situations. Thus, we initiated the HELENA Trial to test the effects of ICR (eu-caloric diet on five days and very low energy intake on two days per week) on metabolic parameters and body composition over one year. We will assess the effectiveness of ICR compared to CCR and a control diet over a 12-week intervention, 12-week maintenance phase and 24-week follow-up in 150 overweight or obese non-smoking adults (50 per group, 50% women). Our primary endpoint is the difference between ICR and CCR with respect to fold-changes in expression levels of 82 candidate genes in abdominal subcutaneous adipose tissue biopsies (SATb) during the intervention phase. The candidate genes represent pathways, which may link obesity-related metabolic alterations with the risk for major chronic diseases. In secondary and exploratory analyses, changes in metabolic, hormonal, inflammatory and metagenomic parameters measured in different biospecimens (SATb, blood, urine, stool) are investigated and effects of ICR/CCR/control on imaging-based measures of subcutaneous, visceral and hepatic fat are evaluated. Our study is the first randomized trial over one year testing the effects of ICR on metabolism, body composition and psychosocial factors in humans. Copyright © 2016 Elsevier Inc. All rights reserved.

  14. HEALTHY study rationale, design and methods: moderating risk of type 2 diabetes in multi-ethnic middle school students

    OpenAIRE

    2009-01-01

    The HEALTHY primary prevention trial was designed and implemented in response to the growing numbers of children and adolescents being diagnosed with type 2 diabetes. The objective was to moderate risk factors for type 2 diabetes. Modifiable risk factors measured were indicators of adiposity and glycemic dysregulation: body mass index ≥85th percentile, fasting glucose ≥5.55 mmol l-1 (100 mg per 100 ml) and fasting insulin ≥180 pmol l-1 (30 μU ml-1). A series of pilot studies established the f...

  15. Evaluation of primary care midwifery in The Netherlands: design and rationale of a dynamic cohort study (DELIVER).

    Science.gov (United States)

    Manniën, Judith; Klomp, Trudy; Wiegers, Therese; Pereboom, Monique; Brug, Johannes; de Jonge, Ank; van der Meijde, Margreeth; Hutton, Eileen; Schellevis, Francois; Spelten, Evelien

    2012-03-20

    In the Netherlands, midwives are autonomous medical practitioners and 78% of pregnant women start their maternity care with a primary care midwife. Scientific research to support evidence-based practice in primary care midwifery in the Netherlands has been sparse. This paper describes the research design and methodology of the multicenter multidisciplinary prospective DELIVER study which is the first large-scale study evaluating the quality and provision of primary midwifery care. Between September 2009 and April 2011, data were collected from clients and their partners, midwives and other healthcare professionals across the Netherlands. Clients from twenty midwifery practices received up to three questionnaires to assess the expectations and experiences of clients (e.g. quality of care, prenatal screening, emotions, health, and lifestyle). These client data were linked to data from the Netherlands Perinatal Register and electronic client records kept by midwives. Midwives and practice assistants from the twenty participating practices recorded work-related activities in a diary for one week, to assess workload. Besides, the midwives were asked to complete a questionnaire, to gain insight into collaboration of midwives with other care providers, their tasks and attitude towards their job, and the quality of the care they provide. Another questionnaire was sent to all Dutch midwifery practices which reveals information regarding the organisation of midwifery practices, provision of preconception care, collaboration with other care providers, and provision of care to ethnic minorities. Data at client, midwife and practice level can be linked. Additionally, partners of pregnant women and other care providers were asked about their expectations and experiences regarding the care delivered by midwives and in six practices client consults were videotaped to objectively assess daily practice. In total, 7685 clients completed at least one questionnaire, 136 midwives and

  16. Evaluation of primary care midwifery in the Netherlands: design and rationale of a dynamic cohort study (DELIVER

    Directory of Open Access Journals (Sweden)

    Manniën Judith

    2012-03-01

    Full Text Available Abstract Background In the Netherlands, midwives are autonomous medical practitioners and 78% of pregnant women start their maternity care with a primary care midwife. Scientific research to support evidence-based practice in primary care midwifery in the Netherlands has been sparse. This paper describes the research design and methodology of the multicenter multidisciplinary prospective DELIVER study which is the first large-scale study evaluating the quality and provision of primary midwifery care. Methods/Design Between September 2009 and April 2011, data were collected from clients and their partners, midwives and other healthcare professionals across the Netherlands. Clients from twenty midwifery practices received up to three questionnaires to assess the expectations and experiences of clients (e.g. quality of care, prenatal screening, emotions, health, and lifestyle. These client data were linked to data from the Netherlands Perinatal Register and electronic client records kept by midwives. Midwives and practice assistants from the twenty participating practices recorded work-related activities in a diary for one week, to assess workload. Besides, the midwives were asked to complete a questionnaire, to gain insight into collaboration of midwives with other care providers, their tasks and attitude towards their job, and the quality of the care they provide. Another questionnaire was sent to all Dutch midwifery practices which reveals information regarding the organisation of midwifery practices, provision of preconception care, collaboration with other care providers, and provision of care to ethnic minorities. Data at client, midwife and practice level can be linked. Additionally, partners of pregnant women and other care providers were asked about their expectations and experiences regarding the care delivered by midwives and in six practices client consults were videotaped to objectively assess daily practice. Discussion In total, 7685

  17. A cross-sectional study on prevalence of chronic obstructive pulmonary disease (COPD) in India: rationale and methods.

    Science.gov (United States)

    Rajkumar, Prabu; Pattabi, Kamaraj; Vadivoo, Selvaraj; Bhome, Arvind; Brashier, Bill; Bhattacharya, Prashanta; Mehendale, Sanjay M

    2017-05-29

    Chronic obstructive pulmonary disease (COPD) is a common preventable and treatable chronic respiratory disease, which affects 210 million people globally. Global and national guidelines exist for the management of COPD. Although evidence-based, they are inadequate to address the phenotypic and genotypic heterogeneity in India. Co-existence of other chronic respiratory diseases can adversely influence the prognosis of COPD.India has a huge burden of COPD with various risk factors and comorbid conditions. However, valid prevalence estimates employing spirometry as the diagnostic tool and data on important comorbid conditions are not available. This study protocol is designed to address this knowledge gap and eventually to build a database to undertake long-term cohort studies to describe the phenotypic and genotypic heterogeneity among COPD patients in India. The primary objective is to estimate the prevalence of COPD among adults aged ≥25 years for each gender in India. The secondary objective is to identify the risk factors for COPD and important comorbid conditions such as asthma and post-tuberculosis sequelae. It is also proposed to validate the currently available definitions for COPD diagnosis in India. A cross-sectional study will be undertaken among the populations of sub-urban areas of Chennai and Shillong cities, which represent the Southern and Northeastern regions of India. We will collect data on sociodemographic variables, economic characteristics, risk factors of COPD and comorbidities. The Global Initiative for Obstructive Lung Disease (GOLD) and Global Initiative for Asthma (GINA) definitions will be used for the diagnosis of COPD and asthma. Data will be analysed for estimation of the prevalence of COPD, asthma and associated factors. This study proposal was approved by the respective institutional ethics committees of participating institutions. The results will be disseminated through publications in the peer-reviewed journals and a report

  18. Barriers, facilitators and preferences for the physical activity of school children. Rationale and methods of a mixed study

    Directory of Open Access Journals (Sweden)

    Martínez-Andrés María

    2012-09-01

    Full Text Available Abstract Background Physical activity interventions in schools environment seem to have shown some effectiveness in the control of the current obesity epidemic in children. However the complexity of behaviors and the diversity of influences related to this problem suggest that we urgently need new lines of insight about how to support comprehensive population strategies of intervention. The aim of this study was to know the perceptions of the children from Cuenca, about their environmental barriers, facilitators and preferences for physical activity. Methods/Design We used a mixed-method design by combining two qualitative methods (analysis of individual drawings and focus groups together with the quantitative measurement of physical activity through accelerometers, in a theoretical sample of 121 children aged 9 and 11 years of schools in the province of Cuenca, Spain. Conclusions Mixed-method study is an appropriate strategy to know the perceptions of children about barriers and facilitators for physical activity, using both qualitative methods for a deeply understanding of their points of view, and quantitative methods for triangulate the discourse of participants with empirical data. We consider that this is an innovative approach that could provide knowledges for the development of more effective interventions to prevent childhood overweight.

  19. Stroke risk associated with balloon based catheter ablation for atrial fibrillation: Rationale and design of the MACPAF Study

    Directory of Open Access Journals (Sweden)

    Schultheiss Heinz-Peter

    2010-07-01

    Full Text Available Abstract Background Catheter ablation of the pulmonary veins has become accepted as a standard therapeutic approach for symptomatic paroxysmal atrial fibrillation (AF. However, there is some evidence for an ablation associated (silent stroke risk, lowering the hope to limit the stroke risk by restoration of rhythm over rate control in AF. The purpose of the prospective randomized single-center study "Mesh Ablator versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation" (MACPAF is to compare the efficacy and safety of two balloon based pulmonary vein ablation systems in patients with symptomatic paroxysmal AF. Methods/Design Patients are randomized 1:1 for the Arctic Front® or the HD Mesh Ablator® catheter for left atrial catheter ablation (LACA. The predefined endpoints will be assessed by brain magnetic resonance imaging (MRI, neuro(psychological tests and a subcutaneously implanted reveal recorder for AF detection. According to statistics 108 patients will be enrolled. Discussion Findings from the MACPAF trial will help to balance the benefits and risks of LACA for symptomatic paroxysmal AF. Using serial brain MRIs might help to identify patients at risk for LACA-associated cerebral thromboembolism. Potential limitations of the study are the single-center design, the existence of a variety of LACA-catheters, the missing placebo-group and the impossibility to assess the primary endpoint in a blinded fashion. Trial registration clinicaltrials.gov NCT01061931

  20. The Preschool Activity, Technology, Health, Adiposity, Behaviour and Cognition (PATH-ABC) cohort study: rationale and design.

    Science.gov (United States)

    Cliff, Dylan P; McNeill, Jade; Vella, Stewart; Howard, Steven J; Kelly, Megan A; Angus, Douglas J; Wright, Ian M; Santos, Rute; Batterham, Marijka; Melhuish, Edward; Okely, Anthony D; de Rosnay, Marc

    2017-04-04

    Prevalence estimates internationally suggest that many preschool-aged children (3-5 years) are insufficiently physically active and engage in high levels of screen-based entertainment. Early childhood is the developmental period for which we know the least about the effects of physical activity on development and health. Likewise, rapid technological advancements in mobile electronic media have made screen-based forms of entertainment for young children ubiquitous, and research demonstrating the impacts on cognition, psychosocial well-being, and health has lagged behind the rate of adoption of these technologies. The purpose of the Preschool Activity, Technology, Health, Adiposity, Behaviour and Cognition (PATH-ABC) study is to investigate if physical activity and screen-based entertainment are independently associated with cognitive and psychosocial development, and health outcomes in young children, and if so, how much and which types of these behaviours might be most influential. The PATH-ABC study is a prospective cohort, aiming to recruit 430 3-5 year-old children. Children are recruited through and complete initial assessments at their Early Childhood Education and Care (ECEC) centre, and then 12-months later at their centre or school. Direct assessments are made of children's habitual physical activity using accelerometry, cognitive (executive function) and language development (expressive vocabulary), psychosocial development (emotional understanding, Theory of Mind, empathy, and heart rate variability), adiposity (body mass index and waist circumference), and cardiovascular health (blood pressure and retinal micro- vasculature). Educators report on children's psychological strengths and difficulties and self-regulation. Parents report on children's habitual use of electronic media and other child, parent and household characteristics. The PATH-ABC study aims to provide evidence to enhance understanding of how much and which types of physical activity and

  1. Study on burnup credit evaluation method at JAERI towards securing criticality safety rationale for management of spent fuel

    International Nuclear Information System (INIS)

    Nomura, Y.

    1998-01-01

    Lately, due to massive accumulation of spent fuel discharged from light water reactors in Japan, it is gradually demanded to introduce the so-called burnup credit methodology into criticality safety design for nuclear fuel cycle facilities, such as spent fuel storage pools and transport casks. In order to save space in the spent fuel storage pool of the Rokkasho Reprocessing Plant, the burnup credit design has been firstly implemented for its criticality safety evaluation. Here, its design conditions and operational control procedures are briefly shown and research using burned fuel at JAERI is explained to support its licensing safety review, focusing on the relevant content of the Nuclear Criticality Safety Handbook of Japan, which has been prepared so far and planned in the near future. Finally, international co-operation for study on burnup credit issues practiced by JAERI is addressed. (author)

  2. Psychological distress and quality of life: rationale and protocol of a prospective cohort study in a rural district in Bangaladesh

    Science.gov (United States)

    Uddin, Mohammed Nazim; Bhar, Sunil; Al Mahmud, Abdullah; Islam, Fakir M Amirul

    2017-01-01

    Introduction A significant proportion of the global burden of disease has been attributed to mental and behavioural disorders. People with mental disorders (MDs) have lower levels of health-related quality of life than those without MDs. Several studies have shown that in low-resource countries, a range of social determinants including poor health literacy is critical in the epidemiological transition of disease outcome. There is a lack of evidence of MDs literacy, the prevalence and risk factors of common mental health conditions, or any validated instruments to measure psychological distress or evaluate the quality of life in rural areas of Bangladesh. Aims The aims of this study are: (1) report the awareness, knowledge, attitudes and practice (KAP) of MDs; (2) estimate the prevalence of and risk factors for psychological distress; (3) measure association of psychological distress and other socio-demographic factors with quality of life and (4) test the feasibility to use Kessler 10-item (K10) and WHO Quality Of Life-BREF (WHOQOL-BREF) questionnaires in rural Bangladesh for measuring psychological distress and quality of life. Methods and analysis A sample of 1500 adults aged 18–59 years and 1200 older adults aged 60–90 years will be interviewed from a multistage cluster random sample. Each participant will go through a face-to-face interview to assess their awareness and KAP of MDs. Information about the participant’s sociodemographic and socioeconomic status will be collected along with the psychological distress (K10) and quality of life (WHOQOL-BREF) questionnaires. Internal consistency, validity, reliability and item discrimination of K10 and WHOQOL-BREF instruments will be determined by using Rasch analysis and regression techniques. Ethics and dissemination Human Ethics Approval was received from the Swinburne University of Technology Human Ethics Committee. Results of this research will be disseminated via scientific forums including peer

  3. Environment and Health in Children Day Care Centres (ENVIRH – Study rationale and protocol

    Directory of Open Access Journals (Sweden)

    J. Araújo-Martins

    2014-11-01

    Full Text Available Background: Indoor air quality (IAQ is considered an important determinant of human health. The association between exposure to volatile organic compounds, particulate matter, house dust mite, molds and bacteria in day care centers (DCC is not completely clear. The aim of this project was to study these effects. Methods – study design: This study comprised two phases. Phase I included an evaluation of 45 DCCs (25 from Lisbon and 20 from Oporto, targeting 5161 children. In this phase, building characteristics, indoor CO2 and air temperature/relative humidity, were assessed. A children's respiratory health questionnaire derived from the ISAAC (International Study on Asthma and Allergies in Children was also distributed. Phase II encompassed two evaluations and included 20 DCCs selected from phase I after a cluster analysis (11 from Lisbon and 9 from Oporto, targeting 2287 children. In this phase, data on ventilation, IAQ, thermal comfort parameters, respiratory and allergic health, airway inflammation biomarkers, respiratory virus infection patterns and parental and child stress were collected. Results: In Phase I, building characteristics, occupant behavior and ventilation surrogates were collected from all DCCs. The response rate of the questionnaire was 61.7% (3186 children.Phase II included 1221 children. Association results between DCC characteristics, IAQ and health outcomes will be provided in order to support recommendations on IAQ and children's health. A building ventilation model will also be developed. Discussion: This paper outlines methods that might be implemented by other investigators conducting studies on the association between respiratory health and indoor air quality at DCC. Resumo: Antecedentes: A qualidade do ar interior (IAQ é considerada um determinante importante da saúde humana. A associação entre a exposição a compostos orgânicos voláteis, partículas, ácaros, bolores e bactérias em

  4. QUest for the Arrhythmogenic Substrate of Atrial fibRillation in Patients Undergoing Cardiac Surgery (QUASAR Study): Rationale and Design.

    Science.gov (United States)

    van der Does, Lisette J M E; Yaksh, Ameeta; Kik, Charles; Knops, Paul; Lanters, Eva A H; Teuwen, Christophe P; Oei, Frans B S; van de Woestijne, Pieter C; Bekkers, Jos A; Bogers, Ad J J C; Allessie, Maurits A; de Groot, Natasja M S

    2016-06-01

    The heterogeneous presentation and progression of atrial fibrillation (AF) implicate the existence of different pathophysiological processes. Individualized diagnosis and therapy of the arrhythmogenic substrate underlying AF may be required to improve treatment outcomes. Therefore, this single-center study aims to identify the arrhythmogenic areas underlying AF by intra-operative, high-resolution, multi-site epicardial mapping in 600 patients with different heart diseases. Participants are divided into 12 groups according to the underlying heart diseases and presence of prior AF episodes. Mapping is performed with a 192-electrode array for 5-10 s during sinus rhythm and (induced) AF of the entire atrial surface. Local activation times are converted into activation and wave maps from which various electrophysiological parameters are derived. Postoperative cardiac rhythm registrations and a 5-year follow-up will show the incidence of postoperative and persistent AF. This project provides the first step in the development of a tool for individual AF diagnosis and treatment.

  5. Eye Care Quality and Accessibility Improvement in the Community (EQUALITY) for adults at risk for glaucoma: study rationale and design.

    Science.gov (United States)

    Owsley, Cynthia; Rhodes, Lindsay A; McGwin, Gerald; Mennemeyer, Stephen T; Bregantini, Mary; Patel, Nita; Wiley, Demond M; LaRussa, Frank; Box, Dan; Saaddine, Jinan; Crews, John E; Girkin, Christopher A

    2015-11-18

    Primary open angle glaucoma is a chronic, progressive eye disease that is the leading cause of blindness among African Americans. Glaucoma progresses more rapidly and appears about 10 years earlier in African Americans as compared to whites. African Americans are also less likely to receive comprehensive eye care when glaucoma could be detected before irreversible blindness. Screening and follow-up protocols for managing glaucoma recommended by eye-care professional organizations are often not followed by primary eye-care providers, both ophthalmologists and optometrists. There is a pressing need to improve both the accessibility and quality of glaucoma care for African Americans. Telemedicine may be an effective solution for improving management and diagnosis of glaucoma because it depends on ocular imaging and tests that can be electronically transmitted to remote reading centers where tertiary care specialists can examine the results. We describe the Eye Care Quality and Accessibility Improvement in the Community project (EQUALITY), set to evaluate a teleglaucoma program deployed in retail-based primary eye care practices serving communities with a large percentage of African Americans. We conducted an observational, 1-year prospective study based in two Walmart Vision Centers in Alabama staffed by primary care optometrists. EQUALITY focuses on new or existing adult patients who are at-risk for glaucoma or already diagnosed with glaucoma. Patients receive dilated comprehensive examinations and diagnostic testing for glaucoma, followed by the optometrist's diagnosis and a preliminary management plan. Results are transmitted to a glaucoma reading center where ophthalmologists who completed fellowship training in glaucoma review results and provide feedback to the optometrist, who manages the care of the patient. Patients also receive eye health education about glaucoma and comprehensive eye care. Research questions include diagnostic and management agreement

  6. A Clinical Study on Hypothyroidism

    International Nuclear Information System (INIS)

    Park, Keun Jo; Park, Sun Yang; Park, Jung Sik; Lee, Myung Chul; Koh, Chang Soon; Lee, Mun Ho

    1976-01-01

    A clinical study was made on 263 patients of hypothyroidism among the 5,970 patients of Various thyroid diseases diagnosed and treated at the Radioisotope Clinic and Laboratory, Seoul National University Hospital from May, 1960 to Aug, 1975. The results obtained with this study are as follows: 1) The etiological classification of hypothyroidism revealed 244 cases (93%) of primary hypothyroidism and 19 cases (7%) of secondary hypothyroidism. 2) The most frequent cause of the thyroprivic primary hypothyroidism was post radioiodine therapy with 109 cases (41.4%). 3) There were 37 cases (14%) of male and 226 cases (86%) of female, showing a ratio of 1 : 6. 4) The majority of patients were between the ages of 30 and 60 with the peak incidence (87 cases, 33%) in their fourth decades of lives. 5) The major symptoms and signs were weakness (97%), edema of face and extremities (92%); Decreased Achilles tendon reflex (87%), cold intolerance (82%), gain in weight (76%), constipation (58%) and cold skin (51%). 6) The cumulative incidence of hypothyroidism in patient treated with 131 I (3-8 mci) was 7.2% at first year, 33.3% at tenth year and the 50% at fourteenth year and the annual increment was 2.9%. 7) The incidence of hypothyroidism related to the numbers of 131 I therapy was not linear. 8) The diagnostic compatibilities of the various tests to hypothyroidism were TSH (100%), T 4 (93.8%), 24-hour-RNIU (91.5%), ATR (86.7%), T 3 RU (66.1%) and BMR (64.9%).

  7. A Clinical Study on Hypothyroidism

    Energy Technology Data Exchange (ETDEWEB)

    Park, Keun Jo; Park, Sun Yang; Park, Jung Sik; Lee, Myung Chul; Koh, Chang Soon; Lee, Mun Ho [Seoul National University College of Medicine, Seoul (Korea, Republic of)

    1976-03-15

    A clinical study was made on 263 patients of hypothyroidism among the 5,970 patients of Various thyroid diseases diagnosed and treated at the Radioisotope Clinic and Laboratory, Seoul National University Hospital from May, 1960 to Aug, 1975. The results obtained with this study are as follows: 1) The etiological classification of hypothyroidism revealed 244 cases (93%) of primary hypothyroidism and 19 cases (7%) of secondary hypothyroidism. 2) The most frequent cause of the thyroprivic primary hypothyroidism was post radioiodine therapy with 109 cases (41.4%). 3) There were 37 cases (14%) of male and 226 cases (86%) of female, showing a ratio of 1 : 6. 4) The majority of patients were between the ages of 30 and 60 with the peak incidence (87 cases, 33%) in their fourth decades of lives. 5) The major symptoms and signs were weakness (97%), edema of face and extremities (92%); Decreased Achilles tendon reflex (87%), cold intolerance (82%), gain in weight (76%), constipation (58%) and cold skin (51%). 6) The cumulative incidence of hypothyroidism in patient treated with {sup 131}I (3-8 mci) was 7.2% at first year, 33.3% at tenth year and the 50% at fourteenth year and the annual increment was 2.9%. 7) The incidence of hypothyroidism related to the numbers of {sup 131}I therapy was not linear. 8) The diagnostic compatibilities of the various tests to hypothyroidism were TSH (100%), T{sub 4} (93.8%), 24-hour-RNIU (91.5%), ATR (86.7%), T{sub 3}RU (66.1%) and BMR (64.9%).

  8. Intermittent Auscultation in Labor: Could It Be Missing Many Pathological (Late) Fetal Heart Rate Decelerations? Analytical Review and Rationale for Improvement Supported by Clinical Cases

    Science.gov (United States)

    Sholapurkar, Shashikant L.

    2015-01-01

    Intermittent auscultation (IA) of fetal heart rate (FHR) is recommended/preferred in low risk labors. Its usage even in developed countries is poised to increase because of perceived benefit of reduction in operative intervention and some disillusionment with the cardiotocography (CTG). Many national guidelines have stipulated regimes (frequency/timing) of IA based on level IV evidence. These tend to get faithfully and exactingly followed. It was observed that deliveries of many unexpectedly asphyxiated infants occurred despite rigorously performed and documented IA compliant with the guidelines. This triggered a reappraisal of the robustness of IA leading to this focused review supplemented by two anonymized cases. It concludes that the current methodology of IA may be flawed in that it poses a risk of missing many or most late (pathological) FHR decelerations, one of the foremost goals of IA. This is because many late decelerations reach their nadir before the end of the contraction. Thus the currently recommended auscultation of FHR for 60 seconds after the contraction by all national guidelines seemed to encompass their “recovery” phase and appeared to be misinterpreted as normal FHR or even as a reassuring accelerative pattern in the clinical practice. A recent recommendation of recording of the FHR as a single figure (rather than a range) does not remedy this anomaly and seems even less informative. It would be better to auscultate FHR before and after the contractions (or contraction to contraction) and take the FHR just before the contraction as the baseline FHR and interpret the FHR after contraction in the context of this baseline. This relatively simple improvement would detect most late FHR decelerations thus ameliorating the risk and significantly enhancing the patient safety. PMID:26566404

  9. Controlled clinical studies of homeopathy.

    Science.gov (United States)

    Mathie, Robert T

    2015-10-01

    Observations about controlled clinical trials expressed by Max Haidvogl in the book Ultra High Dilution (1994) have been appraised from a perspective two decades later. The present commentary briefly examines changes in homeopathy research evidence since 1994 as regards: the published number of randomised controlled trials (RCTs), the use of individualised homeopathic intervention, the 'proven efficacy of homeopathy', and the quality of the evidence. The commentary reflects the details of RCTs that are available in a recently published literature review and by scrutiny of systematic reviews of RCTs in homeopathy. The homeopathy RCT literature grew by 309 records in the 18 years that immediately followed Haidvogl's article, with more than a doubling of the proportion that investigated individualised homeopathy. Discounting one prior publication, the entire systematic review literature on homeopathy RCTs post-dates 1994. A total of 36 condition-specific systematic reviews have been identified in the peer-reviewed literature: 16 of them reported positive, or tentatively positive, conclusions about homeopathy's clinical effectiveness; the other 20 were negative or non-conclusive. Reviews typically have been restricted in the strength of their conclusions by the low quality of the original RCT evidence. Three comprehensive systematic reviews concluded, cautiously, that homeopathy may differ from placebo; a fourth such review reached negative conclusions. A recent high-quality meta-analysis concluded that medicines prescribed in individualised homeopathic treatment may have small, specific, effects. Despite important growth in research activity since 1994, concerns about study quality limit the interpretation of available RCT data. The question whether homeopathic intervention differs from placebo awaits decisive answer. Copyright © 2015 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  10. Rationale, design, and method of the Diabetes & Women's Health study – a study of long-term health implications of glucose intolerance in pregnancy and their determinants

    DEFF Research Database (Denmark)

    Zhang, Cuilin; Hu, Frank B; Olsen, Sjurdur F

    2014-01-01

    or public health interventions in relation to the transition of gestational diabetes mellitus to type 2 diabetes mellitus. To achieve the goal efficiently, we are applying a hybrid design enrolling and collecting data longitudinally from approximately 4000 women with a medical history of gestational...... in determining the transition from gestational diabetes mellitus to overt type 2 diabetes mellitus. These critical data gaps served as the impetus for this Diabetes & Women's Health study with the overall goal of investigating genetic factors and their interactions with risk factors amenable to clinical...... diabetes mellitus in two existing prospective cohorts, the Nurses' Health Study II and the Danish National Birth Cohort. Women who had a medical history of gestational diabetes mellitus in one or more of their pregnancies are eligible for the present study. After enrollment, we follow study participants...

  11. Target Temperature Management after out-of-hospital cardiac arrest--a randomized, parallel-group, assessor-blinded clinical trial--rationale and design

    DEFF Research Database (Denmark)

    Nielsen, Niklas; Wetterslev, Jørn; al-Subaie, Nawaf

    2012-01-01

    Experimental animal studies and previous randomized trials suggest an improvement in mortality and neurologic function with induced hypothermia after cardiac arrest. International guidelines advocate the use of a target temperature management of 32°C to 34°C for 12 to 24 hours after resuscitation...... from out-of-hospital cardiac arrest. A systematic review indicates that the evidence for recommending this intervention is inconclusive, and the GRADE level of evidence is low. Previous trials were small, with high risk of bias, evaluated select populations, and did not treat hyperthermia...... in the control groups. The optimal target temperature management strategy is not known....

  12. Rationale and design of ASSAF-K (A study of the safety and efficacy of anticoagulant therapy in the treatment of atrial fibrillation in Kanagawa

    Directory of Open Access Journals (Sweden)

    Yutaka Hatori, MD, PhD

    2017-04-01

    Conclusions: The results of the study are expected to serve as the basis for providing clinical practice guidance to healthcare institutions in Japan, with the ultimate goals of better characterizing the appropriate use of OACs and providing clinical decision support to physicians to facilitate the design of appropriate therapeutic strategies and the selection of anticoagulants for the management of AF.

  13. A smart-phone application and a companion website for the improvement of the communication skills of children with autism: clinical rationale, technical development and preliminary results.

    Science.gov (United States)

    De Leo, Gianluca; Gonzales, Carol H; Battagiri, Padmaja; Leroy, Gondy

    2011-08-01

    Autism is a complex neurobiological disorder that is part of a group of disorders known as autism spectrum disorders (ASD). Today, one in 150 individuals is diagnosed with autism. Lack of social interaction and problems with communication are the main characteristics displayed by children with ASD. The Picture Exchange Communication System (PECS) is a communication system where children exchange visual symbols as a form of communication. The visual symbols are laminated pictures stored in a binder. We have designed, developed and are currently testing a software application, called PixTalk which works on any Windows Mobile Smart-phone. Teachers and caregivers can access a web site and select from an online library the images to be downloaded on to the Smart-phone. Children can browse and select images to express their intentions, desires, and emotions using PixTalk. Case study results indicate that PixTalk can be used as part of ongoing therapy.

  14. Appendix C: safety design rationale

    International Nuclear Information System (INIS)

    Ghose, S.

    1985-01-01

    A brief discussion of the rationale for safety design of fusion plants is presented in the main text. Further detail safety considerations are presented in this appendix in the form of charts and tables. The author present some of the major safety criteria and other criteria used in blanket selection here

  15. Epigenetic mechanisms involved in differential MDR1 mRNA expression between gastric and colon cancer cell lines and rationales for clinical chemotherapy

    Directory of Open Access Journals (Sweden)

    Kim Kyung-Jong

    2008-08-01

    Full Text Available Abstract Background The membrane transporters such as P-glycoprotein (Pgp, the MDR1 gene product, are one of causes of treatment failure in cancer patients. In this study, the epigenetic mechanisms involved in differential MDR1 mRNA expression were compared between 10 gastric and 9 colon cancer cell lines. Methods The MDR1 mRNA levels were determined using PCR and real-time PCR assays after reverse transcription. Cytotoxicity was performed using the MTT assay. Methylation status was explored by quantification PCR-based methylation and bisulfite DNA sequencing analyses. Results The MDR1 mRNA levels obtained by 35 cycles of RT-PCR in gastric cancer cells were just comparable to those obtained by 22 cycles of RT-PCR in colon cancer cells. Real-time RT-PCR analysis revealed that MDR1 mRNA was not detected in the 10 gastric cancer cell lines but variable MDR1 mRNA levels in 7 of 9 colon cancer cell lines except the SNU-C5 and HT-29 cells. MTT assay showed that Pgp inhibitors such as cyclosporine A, verapamil and PSC833 sensitized Colo320HSR (colon, highest MDR1 expression but not SNU-668 (gastric, highest and SNU-C5 (gastric, no expression to paclitaxel. Quantification PCR-based methylation analysis revealed that 90% of gastric cancer cells, and 33% of colon cancer cells were methylated, which were completely matched with the results obtained by bisulfite DNA sequencing analysis. 5-aza-2'-deoxcytidine (5AC, a DNA methyltransferase inhibitor increased the MDR1 mRNA levels in 60% of gastric cells, and in 11% of colon cancer cells. Trichostatin A (TSA, histone deacetylase inhibitor increased the MDR1 mRNA levels in 70% of gastric cancer cells and 55% of colon cancer cells. The combined treatment of 5AC with TSA increased the MDR1 mRNA levels additively in 20% of gastric cancer cells, but synergistically in 40% of gastric and 11% of colon cancer cells. Conclusion These results indicate that the MDR1 mRNA levels in gastric cancer cells are significantly

  16. Rationale, design and methods for the RIGHT Track Health Study: pathways from childhood self-regulation to cardiovascular risk in adolescence

    Directory of Open Access Journals (Sweden)

    Laurie Wideman

    2016-06-01

    Full Text Available Abstract Background Cardiovascular risk factors during adolescence—including obesity, elevated lipids, altered glucose metabolism, hypertension, and elevated low-grade inflammation—is cause for serious concern and potentially impacts subsequent morbidity and mortality. Despite the importance of these cardiovascular risk factors, very little is known about their developmental origins in childhood. In addition, since adolescence is a time when individuals are navigating major life changes and gaining increasing autonomy from their parents or parental figures, it is a period when control over their own health behaviors (e.g. drug use, sleep, nutrition also increases. The primary aim of this paper is to describe the rationale, design and methods for the RIGHT Track Health Study. This study examines self-regulation as a key factor in the development of cardiovascular risk, and further explores health behaviors as an explanatory mechanism of this association. We also examine potential moderators (e.g. psychosocial adversities such as harsh parenting of this association. Method/design RIGHT Track is a longitudinal study that investigates social and emotional development. The RIGHT Track Health Study prospectively follows participants from age 2 through young adulthood in an effort to understand how self-regulatory behavior throughout childhood alters the trajectories of various cardiovascular risk factors during late adolescence via health behaviors. Individuals from RIGHT Track were re-contacted and invited to participate in adolescent data collection (~16.5, 17.5 and 18+ years old. Individuals completed assessments of body composition, anthropometric indicators, fitness testing (via peak oxygen consumption, heart rate variability during orthostatic challenge, 7-day accelerometry for physical activity and sleep, 24-h dietary recalls, and blood analysis for biomarkers related to metabolic syndrome, inflammatory status and various hormones and

  17. Rationale, design and methods for the RIGHT Track Health Study: pathways from childhood self-regulation to cardiovascular risk in adolescence.

    Science.gov (United States)

    Wideman, Laurie; Calkins, Susan D; Janssen, James A; Lovelady, Cheryl A; Dollar, Jessica M; Keane, Susan P; Perrin, Eliana M; Shanahan, Lilly

    2016-06-01

    Cardiovascular risk factors during adolescence-including obesity, elevated lipids, altered glucose metabolism, hypertension, and elevated low-grade inflammation-is cause for serious concern and potentially impacts subsequent morbidity and mortality. Despite the importance of these cardiovascular risk factors, very little is known about their developmental origins in childhood. In addition, since adolescence is a time when individuals are navigating major life changes and gaining increasing autonomy from their parents or parental figures, it is a period when control over their own health behaviors (e.g. drug use, sleep, nutrition) also increases. The primary aim of this paper is to describe the rationale, design and methods for the RIGHT Track Health Study. This study examines self-regulation as a key factor in the development of cardiovascular risk, and further explores health behaviors as an explanatory mechanism of this association. We also examine potential moderators (e.g. psychosocial adversities such as harsh parenting) of this association. RIGHT Track is a longitudinal study that investigates social and emotional development. The RIGHT Track Health Study prospectively follows participants from age 2 through young adulthood in an effort to understand how self-regulatory behavior throughout childhood alters the trajectories of various cardiovascular risk factors during late adolescence via health behaviors. Individuals from RIGHT Track were re-contacted and invited to participate in adolescent data collection (~16.5, 17.5 and 18(+) years old). Individuals completed assessments of body composition, anthropometric indicators, fitness testing (via peak oxygen consumption), heart rate variability during orthostatic challenge, 7-day accelerometry for physical activity and sleep, 24-h dietary recalls, and blood analysis for biomarkers related to metabolic syndrome, inflammatory status and various hormones and cytokines. Individuals also completed extensive self

  18. Rationale, design and methods of the Study of Work and Pain (SWAP): a cluster randomised controlled trial testing the addition of a vocational advice service to best current primary care for patients with musculoskeletal pain (ISRCTN 52269669).

    Science.gov (United States)

    Bishop, Annette; Wynne-Jones, Gwenllian; Lawton, Sarah A; van der Windt, Danielle; Main, Chris; Sowden, Gail; Burton, A Kim; Lewis, Martyn; Jowett, Sue; Sanders, Tom; Hay, Elaine M; Foster, Nadine E

    2014-07-10

    Musculoskeletal pain is a major contributor to short and long term work absence. Patients seek care from their general practitioner (GP) and yet GPs often feel ill-equipped to deal with work issues. Providing a vocational case management service in primary care, to support patients with musculoskeletal problems to remain at or return to work, is one potential solution but requires robust evaluation to test clinical and cost-effectiveness. This protocol describes a cluster randomised controlled trial, with linked qualitative interviews, to investigate the effect of introducing a vocational advice service into general practice, to provide a structured approach to managing work related issues in primary care patients with musculoskeletal pain who are absent from work or struggling to remain in work. General practices (n = 6) will be randomised to offer best current care or best current care plus a vocational advice service. Adults of working age who are absent from or struggling to remain in work due to a musculoskeletal pain problem will be invited to participate and 330 participants will be recruited. Data collection will be through patient completed questionnaires at baseline, 4 and 12 months. The primary outcome is self-reported work absence at 4 months. Incremental cost-utility analysis will be undertaken to calculate the cost per additional QALY gained and incremental net benefits. A linked interview study will explore the experiences of the vocational advice service from the perspectives of GPs, nurse practitioners (NPs), patients and vocational advisors. This paper presents the rationale, design, and methods of the Study of Work And Pain (SWAP) trial. The results of this trial will provide evidence to inform primary care practice and guide the development of services to provide support for musculoskeletal pain patients with work-related issues. Current Controlled Trials ISRCTN52269669.

  19. West End Walkers 65+: A randomised controlled trial of a primary care-based walking intervention for older adults: Study rationale and design

    Directory of Open Access Journals (Sweden)

    Rowe David A

    2011-02-01

    Full Text Available Abstract Background In Scotland, older adults are a key target group for physical activity intervention due to the large proportion who are inactive. The health benefits of an active lifestyle are well established but more research is required on the most effective interventions to increase activity in older adults. The 'West End Walkers 65+' randomised controlled trial aims to examine the feasibility of delivering a pedometer-based walking intervention to adults aged ≥65 years through a primary care setting and to determine the efficacy of this pilot. The study rationale, protocol and recruitment process are discussed in this paper. Methods/Design The intervention consisted of a 12-week pedometer-based graduated walking programme and physical activity consultations. Participants were randomised into an immediate intervention group (immediate group or a 12-week waiting list control group (delayed group who then received the intervention. For the pilot element of this study, the primary outcome measure was pedometer step counts. Secondary outcome measures of sedentary time and physical activity (time spent lying/sitting, standing or walking; activPAL™ monitor, mood (Positive and Negative Affect Schedule, functional ability (Perceived Motor-Efficacy Scale for Older Adults, quality of life (Short-Form (36 Health Survey version 2 and loneliness (UCLA Loneliness Scale were assessed. Focus groups with participants and semi-structured interviews with the research team captured their experiences of the intervention. The feasibility component of this trial examined recruitment via primary care and retention of participants, appropriateness of the intervention for older adults and the delivery of the intervention by a practice nurse. Discussion West End Walkers 65+ will determine the feasibility and pilot the efficacy of delivering a pedometer-based walking intervention through primary care to Scottish adults aged ≥65 years. The study will also

  20. Randomized comparison of the clinical outcome of single versus multiple arterial grafts: the ROMA trial-rationale and study protocol.

    Science.gov (United States)

    Gaudino, Mario; Alexander, John H; Bakaeen, Faisal G; Ballman, Karla; Barili, Fabio; Calafiore, Antonio Maria; Davierwala, Piroze; Goldman, Steven; Kappetein, Peter; Lorusso, Roberto; Mylotte, Darren; Pagano, Domenico; Ruel, Marc; Schwann, Thomas; Suma, Hisayoshi; Taggart, David P; Tranbaugh, Robert F; Fremes, Stephen

    2017-12-01

    The primary hypothesis of the ROMA trial is that in patients undergoing primary isolated non-emergent coronary artery bypass grafting, the use of 2 or more arterial grafts compared with a single arterial graft (SAG) is associated with a reduction in the composite outcome of death from any cause, any stroke, post-discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in these patients, the use of 2 or more arterial grafts compared with a SAG is associated with improved survival. The ROMA trial is a prospective, unblinded, randomized event-driven multicentre trial comprising at least 4300 subjects. Patients younger than 70 years with left main and/or multivessel disease will be randomized to a SAG or multiple arterial grafts to the left coronary system in a 1:1 fashion. Permuted block randomization stratified by the centre and the type of second arterial graft will be used. The primary outcome will be a composite of death from any cause, any stroke, post-discharge myocardial infarction and/or repeat revascularization. The secondary outcome will be all-cause mortality. The primary safety outcome will be a composite of death from any cause, any stroke and any myocardial infarction. In all patients, 1 internal thoracic artery will be anastomosed to the left anterior descending coronary artery. For patients randomized to the SAG group, saphenous vein grafts will be used for all non-left anterior descending target vessels. For patients randomized to the multiple arterial graft group, the main target vessel of the lateral wall will be grafted with either a radial artery or a second internal thoracic artery. Additional grafts for the multiple arterial graft group can be saphenous veins or supplemental arterial conduits. To detect a 20% relative reduction in the primary outcome, with 90% power at 5% alpha and assuming a time-to-event analysis, the sample size must include 845 events (and 3650 patients). To detect a 20% relative reduction in the secondary outcome, with 80% power at 5% alpha, the sample size must include 631 events (and 3650 patients). To be conservative, the sample size will be set at 4300 patients. The primary outcome will be tested according to the intention-to-treat principle. The primary analysis will be a Cox proportional hazards regression model, with the treatment arm included as a covariate. If non-proportional hazards are observed, alternatives to Cox proportional hazards regression will be explored. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  1. Rationales for Commonly "Challenged" Taught Books.

    Science.gov (United States)

    Shugert, Diane P., Ed.; And Others

    1983-01-01

    Intended for teachers, this focused journal issue contains separate rationales for teaching books that have been challenged as appropriate instructional materials. Following a discussion of the purpose for rationales and suggestions for using them, the journal presents rationales for teaching the following books: "To Kill a Mockingbird,""The Diary…

  2. Rationale and protocol of a trial for prevention of diabetic atherosclerosis by using antiplatelet drugs: study of Diabetic Atherosclerosis Prevention by Cilostazol (DAPC study

    Directory of Open Access Journals (Sweden)

    Kawamori Ryuzo

    2006-08-01

    Full Text Available Abstract Background Secondary treatment of arteriosclerosis may be applicable for the primary prevention of atherosclerosis in diabetic patients. This prospective, 2-year follow-up study was designed to determine the efficacy and safety of antiplatelet therapy in the prevention of atherosclerosis of diabetic subjects. Methods Patients with type 2 diabetes and arteriosclerosis obliterans from the Eastern Asian countries were registered online and randomly assigned either to the aspirin group (81–100 mg/day or the cilostazol group (100–200 mg/day in this international, 2-year, prospective follow-up interventional study. Results The primary study endpoint was changes in right and left maximum intima-media thickness of the common carotid artery. Secondary endpoints include changes in right and left maximum intima-media thickness of the internal carotid artery; semiquantitative evaluation of cerebral infarction by magnetic resonance imaging; cardiovascular events including sudden death, stroke, transient cerebral ischemic attacks, acute myocardial infarction, angina, and progression of arteriosclerosis obliterans; overall death; withdrawal; and change in ankle-brachial pressure index. Conclusion This is the first study to use an online system that was developed in Asian countries for pooling data from an international clinical trial. These findings are expected to help in the prevention of diabetic atherosclerosis and subsequent cardiovascular and cerebrovascular disease.

  3. A randomized controlled trial to evaluate utilization of physical activity recommendations among patients of cardiovascular healthcare centres in Eastern Slovakia: study design and rationale of the AWATAR study.

    Science.gov (United States)

    Zelko, Aurel; Bukova, Alena; Kolarcik, Peter; Bakalar, Peter; Majercak, Ivan; Potocnikova, Jana; Reijneveld, Sijmen A; van Dijk, Jitse P

    2018-04-04

    Guidelines on modifiable risk factors regarding cardiological patients are poorly implemented in clinical practice perhaps due to low health literacy. Several digital tools for improving lifestyle and behavioural intervention were developed. Our primary aim is to evaluate the effectiveness of a digital exercise prescription tool on the adherence to physical activity recommendations among patients with cardiovascular diseases. A randomized controlled trial will be realized in cooperation with Cardiovascular Health Centres in Eastern Slovakia. Patients recruited through their cardiologists, will be randomised at 1:1 ratio to the three-months' experimental condition or control condition. The experimental group will receive standard lifestyle consultation leading to individually optimized prescription of physical activity. The control group will receive standard, usual-cardio-care lifestyle counselling, also in the domain of physical activity. The digital system will be used for optimized exercise prescription. The primary outcome is a change in the patient's adherence to exercise recommendations. Data will be collected in both groups prior to consultation and after 3 months. This study protocol presents background and design of a randomized control trial to investigate the effectiveness of a digital system-provide exercise prescription tool on the adherence to physical activity recommendations. An optimized exercise prescription that better reflects patient's diagnosis, comorbidities and medication can have a significant impact on secondary prevention of cardiovascular disease. This trial can provide important evidence about the effectiveness of digital exercise guidance in everyday practice of cardiovascular healthcare. The study was registered on 1st November, 2017 and is available online at ClinicalTrials.gov (ID: NCT03329053 ).

  4. The rationale/design of the Guimarães/Vizela study: a multimodal population-based cohort study to determine global cardiovascular risk and disease.

    Science.gov (United States)

    Cunha, Pedro Guimarães; Cotter, Jorge; Oliveira, Pedro; Vila, Isabel; Sousa, Nuno

    2014-06-01

    Cardiovascular disease and dementia are growing medical and social problems in aging societies. Appropriate knowledge of cardiovascular disease and cognitive decline risk factors (RFs) are critical for global CVR health preventive intervention. Many epidemiological studies use case definition based on data collected/measured in a single visit, a fact that can overestimate prevalence rates and distant from clinical practice demanding criteria. Portugal displays an elevated stroke mortality rate. However, population's global CV risk characterization is limited, namely, considering traditional/nontraditional RF and new intermediate phenotypes of CV and renal disease. Association of hemodynamic variables (pulse wave velocity and central blood pressure) with global CVR stratification, cognitive performance, and kidney disease are practically inexistent at a dwelling population level. After reviewing published data, we designed a population-based cohort study to analyze the prevalence of these cardiovascular RFs and intermediate phenotypes, using random sampling of adult dwellers living in 2 adjacent cities. Strict definition of phenotypes was planned: subjects were observed twice, and several hemodynamic and other biological variables measured at least 3 months apart. Three thousand thirty-eight subjects were enrolled, and extensive data collection (including central and peripheral blood pressure, pulse wave velocity), sample processing, and biobank edification were carried out. One thousand forty-seven cognitive evaluations were performed. Seeking for CV risk reclassification, early identification of subjects at risk, and evidence of early vascular aging and cognitive and renal function decline, using the strict daily clinical practice criteria, will lead to better resource allocation in preventive measures at a population level.

  5. The 'Women's Lifestyle Study', 2-year randomized controlled trial of physical activity counselling in primary health care: rationale and study design

    Directory of Open Access Journals (Sweden)

    Dowell Anthony C

    2007-07-01

    Full Text Available Abstract Background Physical inactivity is an independent risk factor for diabetes and heart disease. There is evidence that increasing physical activity can reduce the risk of developing these chronic diseases, but less evidence about effective ways to increase adherence to physical activity. Interventions are therefore needed that produce sustained increases in adherence to physical activity, are cost-effective and improve clinical endpoints. Methods The Women's Lifestyle Study is a two year randomized controlled trial involving a nurse-led intervention to increase physical activity in 40–74 year old physically inactive women recruited from primary care. Baseline measures were assessed in a face-to-face interview with a primary care nurse. The intervention involved delivery of a 'Lifestyle script' by a primary care nurse followed by telephone counselling for nine months and a face-to-face nurse visit at six months. Outcome measurements are assessed at 12 and 24 months. The primary outcome is physical activity measured using a validated physical activity questionnaire. Secondary outcomes include blood pressure, weight, waist circumference, physical fitness (step test, serum HbA1c, fasting glucose, lipids, insulin, and quality of life (SF36. Costs were measured prospectively to allow a subsequent cost-effectiveness evaluation if the trial is positive. Discussion Due to report in 2008, the Women's Lifestyle Study tests the effectiveness of an enhanced low-cost, evidence-based intervention in increasing physical activity, and improving cardiovascular and diabetes risk indicators over two years. If successful in demonstrating improvements in health outcomes, this randomized controlled trial will be the first to demonstrate long-term cardiovascular and diabetes risk health benefit, in addition to improvements in physical activity, from a sustainable physical activity intervention based in primary care. Trial Registration Australian Clinical Trials

  6. A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction with point of care testing in a general practice setting - rationale, design and baseline characteristics.

    Science.gov (United States)

    Laurence, Caroline; Gialamas, Angela; Yelland, Lisa; Bubner, Tanya; Ryan, Philip; Willson, Kristyn; Glastonbury, Briony; Gill, Janice; Shephard, Mark; Beilby, Justin

    2008-08-06

    Point of care testing (PoCT) may be a useful adjunct in the management of chronic conditions in general practice (GP). The provision of pathology test results at the time of the consultation could lead to enhanced clinical management, better health outcomes, greater convenience and satisfaction for patients and general practitioners (GPs), and savings in costs and time. It could also result in inappropriate testing, increased consultations and poor health outcomes resulting from inaccurate results. Currently there are very few randomised controlled trials (RCTs) in GP that have investigated these aspects of PoCT. The Point of Care Testing in General Practice Trial (PoCT Trial) was an Australian Government funded multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost effectiveness and satisfaction of PoCT in a GP setting.The PoCT Trial covered an 18 month period with the intervention consisting of the use of PoCT for seven tests used in the management of patients with diabetes, hyperlipidaemia and patients on anticoagulant therapy. The primary outcome measure was the proportion of patients within target range, a measure of therapeutic control. In addition, the PoCT Trial investigated the safety of PoCT, impact of PoCT on patient compliance to medication, stakeholder satisfaction, cost effectiveness of PoCT versus laboratory testing, and influence of geographic location. The paper provides an overview of the Trial Design, the rationale for the research methodology chosen and how the Trial was implemented in a GP environment. The evaluation protocol and data collection processes took into account the large number of patients, the broad range of practice types distributed over a large geographic area, and the inclusion of pathology test results from multiple pathology laboratories.The evaluation protocol developed reflects the complexity of the Trial setting, the Trial Design and the approach taken within the funding

  7. A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction with point of care testing in a general practice setting – rationale, design and baseline characteristics

    Directory of Open Access Journals (Sweden)

    Glastonbury Briony

    2008-08-01

    Full Text Available Abstract Background Point of care testing (PoCT may be a useful adjunct in the management of chronic conditions in general practice (GP. The provision of pathology test results at the time of the consultation could lead to enhanced clinical management, better health outcomes, greater convenience and satisfaction for patients and general practitioners (GPs, and savings in costs and time. It could also result in inappropriate testing, increased consultations and poor health outcomes resulting from inaccurate results. Currently there are very few randomised controlled trials (RCTs in GP that have investigated these aspects of PoCT. Design/Methods The Point of Care Testing in General Practice Trial (PoCT Trial was an Australian Government funded multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost effectiveness and satisfaction of PoCT in a GP setting. The PoCT Trial covered an 18 month period with the intervention consisting of the use of PoCT for seven tests used in the management of patients with diabetes, hyperlipidaemia and patients on anticoagulant therapy. The primary outcome measure was the proportion of patients within target range, a measure of therapeutic control. In addition, the PoCT Trial investigated the safety of PoCT, impact of PoCT on patient compliance to medication, stakeholder satisfaction, cost effectiveness of PoCT versus laboratory testing, and influence of geographic location. Discussion The paper provides an overview of the Trial Design, the rationale for the research methodology chosen and how the Trial was implemented in a GP environment. The evaluation protocol and data collection processes took into account the large number of patients, the broad range of practice types distributed over a large geographic area, and the inclusion of pathology test results from multiple pathology laboratories. The evaluation protocol developed reflects the complexity of the Trial setting

  8. Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011.

    Science.gov (United States)

    Doshi, Peter; Hur, Peter; Jones, Mark; Albarmawi, Husam; Jefferson, Tom; Morgan, Daniel J; Spears, Patricia A; Powers, John H

    2017-10-01

    Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use "noninferiority" hypotheses allowing a degree of inferior efficacy deemed "clinically acceptable" compared with an older effective drug, in exchange for nonefficacy benefits (eg, decreased adverse effects). Considering these different benefit-harm trade-offs, proper informed consent necessitates supplying different information on the purposes of superiority and noninferiority trials. To determine the degree to which the study purpose is explained to potential participants in randomized clinical trials of antibiotics and the degree to which study protocols justify their selection of noninferiority hypotheses and amount of "clinically acceptable" inferiority. Cross-sectional analysis of study protocols, statistical analysis plans (SAPs), and informed consent forms (ICFs) from clinical study reports submitted to the European Medicines Agency. The ICFs were read by both methodologists and patient investigators. Protocols and SAPs were used as the reference standard to determine prespecified primary hypothesis and record rationale for selection of noninferiority hypotheses and noninferiority margins. This information was cross-referenced against ICFs to determine whether ICFs explained the study purpose. We obtained trial documents from 78 randomized trials with prespecified efficacy hypotheses (6 superiority, 72 noninferiority) for 17 antibiotics conducted between 1991 and 2011 that enrolled 39 407 patients. Fifty were included in the ICF analysis. All ICFs contained sections describing study purpose; however, none consistently conveyed study hypothesis to both methodologists and patient investigators. Methodologists found that 1 of 50 conveyed a study purpose. Patient investigators found that 11 of 50 conveyed a study

  9. Design and rationale for examining neuroimaging genetics in ischemic stroke

    Science.gov (United States)

    Giese, Anne-Katrin; Schirmer, Markus D.; Donahue, Kathleen L.; Cloonan, Lisa; Irie, Robert; Winzeck, Stefan; Bouts, Mark J.R.J.; McIntosh, Elissa C.; Mocking, Steven J.; Dalca, Adrian V.; Sridharan, Ramesh; Xu, Huichun; Frid, Petrea; Giralt-Steinhauer, Eva; Holmegaard, Lukas; Roquer, Jaume; Wasselius, Johan; Cole, John W.; McArdle, Patrick F.; Broderick, Joseph P.; Jimenez-Conde, Jordi; Jern, Christina; Kissela, Brett M.; Kleindorfer, Dawn O.; Lemmens, Robin; Lindgren, Arne; Meschia, James F.; Rundek, Tatjana; Sacco, Ralph L.; Schmidt, Reinhold; Sharma, Pankaj; Slowik, Agnieszka; Thijs, Vincent; Woo, Daniel; Worrall, Bradford B.; Kittner, Steven J.; Mitchell, Braxton D.; Rosand, Jonathan; Golland, Polina; Wu, Ona

    2017-01-01

    Objective: To describe the design and rationale for the genetic analysis of acute and chronic cerebrovascular neuroimaging phenotypes detected on clinical MRI in patients with acute ischemic stroke (AIS) within the scope of the MRI–GENetics Interface Exploration (MRI-GENIE) study. Methods: MRI-GENIE capitalizes on the existing infrastructure of the Stroke Genetics Network (SiGN). In total, 12 international SiGN sites contributed MRIs of 3,301 patients with AIS. Detailed clinical phenotyping with the web-based Causative Classification of Stroke (CCS) system and genome-wide genotyping data were available for all participants. Neuroimaging analyses include the manual and automated assessments of established MRI markers. A high-throughput MRI analysis pipeline for the automated assessment of cerebrovascular lesions on clinical scans will be developed in a subset of scans for both acute and chronic lesions, validated against gold standard, and applied to all available scans. The extracted neuroimaging phenotypes will improve characterization of acute and chronic cerebrovascular lesions in ischemic stroke, including CCS subtypes, and their effect on functional outcomes after stroke. Moreover, genetic testing will uncover variants associated with acute and chronic MRI manifestations of cerebrovascular disease. Conclusions: The MRI-GENIE study aims to develop, validate, and distribute the MRI analysis platform for scans acquired as part of clinical care for patients with AIS, which will lead to (1) novel genetic discoveries in ischemic stroke, (2) strategies for personalized stroke risk assessment, and (3) personalized stroke outcome assessment. PMID:28852707

  10. Blood irradiation: Rationale and technique

    International Nuclear Information System (INIS)

    Lewis, M.C.

    1990-01-01

    Upon request by the local American Red Cross, the Savannah Regional Center for Cancer Care irradiates whole blood or blood components to prevent post-transfusion graft-versus-host reaction in patients who have severely depressed immune systems. The rationale for blood irradiation, the total absorbed dose, the type of patients who require irradiated blood, and the regulations that apply to irradiated blood are presented. A method of irradiating blood using a linear accelerator is described

  11. The Nightingale study: rationale, study design and baseline characteristics of a prospective cohort study on shift work and breast cancer risk among nurses.

    Science.gov (United States)

    Pijpe, Anouk; Slottje, Pauline; van Pelt, Cres; Stehmann, Floor; Kromhout, Hans; van Leeuwen, Flora E; Vermeulen, Roel C H; Rookus, Matti A

    2014-01-29

    Evidence for the carcinogenicity of shift work in humans is limited because of significant heterogeneity of the results, thus more in-depth research in needed. The Nightingale Study is a nationwide prospective cohort study on occupational exposures and risks of chronic diseases among female nurses and focuses on the potential association between shift work and risk of breast cancer. The study design, methods, and baseline characteristics of the cohort are described. The source population for the cohort comprised 18 to 65 year old women who were registered as having completed training to be a nurse in the nationwide register for healthcare professionals in the Netherlands. Eligible women were invited to complete a web-based questionnaire including full job history, a detailed section on all domains of shift work (shift system, cumulative exposure, and shift intensity) and potential confounding factors, and an informed consent form for linkage with national (disease) registries. Women were also asked to donate toenail clippings as a source of DNA for genetic analyses. Between October 6, 2011 and February 1, 2012, 31% of the 192,931 women who were invited to participate completed the questionnaire, yielding a sample size of 59,947 cohort members. The mean age of the participants was 46.9 year (standard deviation 11.0 years). Toenail clippings were provided by 23,439 participants (39%). Results from the Nightingale Study will contribute to the scientific evidence of potential shift work-related health risks among nurses and will help develop preventive measures and policy aimed at reducing these risks.

  12. The Nightingale study: rationale, study design and baseline characteristics of a prospective cohort study on shift work and breast cancer risk among nurses

    Science.gov (United States)

    2014-01-01

    Background Evidence for the carcinogenicity of shift work in humans is limited because of significant heterogeneity of the results, thus more in-depth research in needed. The Nightingale Study is a nationwide prospective cohort study on occupational exposures and risks of chronic diseases among female nurses and focuses on the potential association between shift work and risk of breast cancer. The study design, methods, and baseline characteristics of the cohort are described. Methods/Design The source population for the cohort comprised 18 to 65 year old women who were registered as having completed training to be a nurse in the nationwide register for healthcare professionals in the Netherlands. Eligible women were invited to complete a web-based questionnaire including full job history, a detailed section on all domains of shift work (shift system, cumulative exposure, and shift intensity) and potential confounding factors, and an informed consent form for linkage with national (disease) registries. Women were also asked to donate toenail clippings as a source of DNA for genetic analyses. Between October 6, 2011 and February 1, 2012, 31% of the 192,931 women who were invited to participate completed the questionnaire, yielding a sample size of 59,947 cohort members. The mean age of the participants was 46.9 year (standard deviation 11.0 years). Toenail clippings were provided by 23,439 participants (39%). Discussion Results from the Nightingale Study will contribute to the scientific evidence of potential shift work-related health risks among nurses and will help develop preventive measures and policy aimed at reducing these risks. PMID:24475944

  13. Yoga as a complementary treatment for smoking cessation: rationale, study design and participant characteristics of the Quitting-in-Balance study

    Directory of Open Access Journals (Sweden)

    Jennings Ernestine

    2010-04-01

    Full Text Available Abstract Background Tobacco smoking remains the leading preventable cause of death among American women. Exercise has shown promise as an aid to smoking cessation because it reduces weight gain and weight concerns, improves affect, and reduces nicotine withdrawal symptoms and cigarette craving. Studies have shown that the practice of yoga improves weight control, and reduces perceived stress and negative affect. Yoga practice also includes regulation of breathing and focused attention, both of which may enhance stress reduction and improve mood and well-being and may improve cessation outcomes. Methods/Design This pilot efficacy study is designed to examine the rates of cessation among women randomized to either a novel, 8-week Yoga plus Cognitive Behavioral Therapy (CBT smoking cessation intervention versus a Wellness program plus the same CBT smoking cessation intervention. Outcome measures include 7-day point prevalence abstinence at end of treatment, 3 and 6 months follow up and potential mediating variables (e.g., confidence in quitting smoking, self-efficacy. Other assessments include measures of mindfulness, spirituality, depressive symptoms, anxiety and perceived health (SF-36. Discussion Innovative treatments are needed that address barriers to successful smoking cessation among men and women. The design chosen for this study will allow us to explore potential mediators of intervention efficacy so that we may better understand the mechanism(s by which yoga may act as an effective complementary treatment for smoking cessation. If shown to be effective, yoga can offer an alternative to traditional exercise for reducing negative symptoms that often accompany smoking cessation and predict relapse to smoking among recent quitters. Trial Registration ClinicalTrials NCT00492310

  14. A randomized controlled trial of long term effect of BCM guided fluid management in MHD patients (BOCOMO study: rationales and study design

    Directory of Open Access Journals (Sweden)

    Liu Li

    2012-09-01

    Full Text Available Abstract Background Bioimpedance analysis (BIA has been reported as helpful in identifying hypervolemia. Observation data showed that hypervolemic maintenance hemodialysis (MHD patients identified using BIA methods have higher mortality risk. However, it is not known if BIA-guided fluid management can improve MHD patients’ survival. The objectives of the BOCOMO study are to evaluate the outcome of BIA guided fluid management compared with standard care. Methods This is a multicenter, prospective, randomized, controlled trial. More than 1300 participants from 16 clinical sites will be included in the study. The enrolment period will last 6 months, and minimum length of follow-up will be 36 months. MHD patients aged between 18 years and 80 years who have been on MHD for at least 3 months and meet eligibility criteria will be invited to participate in the study. Participants will be randomized to BIA arm or control arm in a 1:1 ratio. A portable whole body bioimpedance spectroscopy device (BCM—Fresenius Medical Care D GmbH will be used for BIA measurement at baseline for both arms of the study. In the BIA arm, additional BCM measurements will be performed every 2 months. The primary intent-to-treat analysis will compare outcomes for a composite endpoint of death, acute myocardial infarction, stroke or incident peripheral arterial occlusive disease between groups. Secondary endpoints will include left ventricular wall thickness, blood pressure, medications, and incidence and length of hospitalization. Discussions Previous results regarding the benefit of strict fluid control are conflicting due to small sample sizes and unstable dry weight estimating methods. To our knowledge this is the first large-scale, multicentre, prospective, randomized controlled trial to assess whether BIS-guided volume management improves outcomes of MHD patients. The endpoints of the BOCOMO study are of utmost importance to health care providers. In order to obtain

  15. Mechanism of action study to evaluate the effect of rosiglitazone on bone in postmenopausal women with type 2 diabetes mellitus: rationale, study design and baseline characteristics

    Science.gov (United States)

    Fitzpatrick, Lorraine A.; Bilezikian, John P.; Wooddell, Margaret; Paul, Gitanjali; Kolatkar, Nikheel S.; Nino, Antonio J.; Miller, Colin G.; Bogado, Cesar E.; Arnaud, Claude D.; Cobitz, Alexander R.

    2012-01-01

    study will provide information about RSG bone effects in a population of postmenopausal women at risk for bone loss and subsequent fracture. ClinicalTrials.gov number NCT00679939 PMID:27536422

  16. Psychological and personality factors in type 2 diabetes mellitus, presenting the rationale and exploratory results from The Maastricht Study, a population-based cohort study.

    Science.gov (United States)

    van Dooren, Fleur E P; Denollet, Johan; Verhey, Frans R J; Stehouwer, Coen D A; Sep, Simone J S; Henry, Ronald M A; Kremers, Stef P J; Dagnelie, Pieter C; Schaper, Nicolaas C; van der Kallen, Carla J H; Koster, Annemarie; Pouwer, Frans; Schram, Miranda T

    2016-01-27

    Strong longitudinal evidence exists that psychological distress is associated with a high morbidity and mortality risk in type 2 diabetes. Little is known about the biological and behavioral mechanisms that may explain this association. Moreover, the role of personality traits in these associations is still unclear. In this paper, we first describe the design of the psychological part of The Maastricht Study that aims to elucidate these mechanisms. Next, we present exploratory results on the prevalence of depression, anxiety and personality traits in type 2 diabetes. Finally, we briefly discuss the importance of these findings for clinical research and practice. We measured psychological distress and depression using the MINI diagnostic interview, the PHQ-9 and GAD-7 questionnaires in the first 864 participants of The Maastricht Study, a large, population-based cohort study. Personality traits were measured by the DS14 and Big Five personality questionnaires. Type 2 diabetes was assessed by an oral glucose tolerance test. Logistic regression analyses were used to estimate the associations of depression, anxiety and personality with type 2 diabetes, adjusted for age, sex and education level. Individuals with type 2 diabetes had higher levels of depressive and anxiety symptoms, odds ratios (95 % CI) were 3.15 (1.49; 6.67), 1.73 (0.83-3.60), 1.50 (0.72-3.12), for PHQ-9 ≥ 10, current depressive disorder and GAD-7 ≥ 10, respectively. Type D personality, social inhibition and negative affectivity were more prevalent in type 2 diabetes, odds ratios were 1.95 (1.23-3.10), 1.35 (0.93-1.94) and 1.70 (1.14-2.51), respectively. Individuals with type 2 diabetes were less extraverted, less conscientious, less agreeable and less emotionally stable, and similar in openness to individuals without type 2 diabetes, although effect sizes were small. Individuals with type 2 diabetes experience more psychological distress and have different personality traits compared to individuals

  17. Bridging the gap in heart failure prevention: rationale and design of the Nurse-led Intervention for Less Chronic Heart Failure (NIL-CHF) Study

    DEFF Research Database (Denmark)

    Carrington, Melinda J; Stewart, Simon; de Courten, Barbora

    2010-01-01

    AIMS: The primary objective of the Nurse-led Intervention for Less Chronic Heart Failure (NIL-CHF) Study is to develop a programme of care that cost-effectively prevents the development of chronic heart failure (CHF). Methods NIL-CHF is a randomized controlled trial of a hybrid, home- and clinic-...

  18. Design and Rationale of a Comparative Effectiveness Study to Evaluate Two Acupuncture Methods for the Treatment of Headaches Associated with Traumatic Brain Injury

    Science.gov (United States)

    2011-01-01

    origins (4) Drug/opioid desensitization (with abuse potential) (5) Somatic (sleep, appetite, sexual, and energy) dys- function. Problems with Current Care...participants who learn about the study through institutional review board (IRB)–approved advertisements or who are referred from the TBI clinic are screened

  19. Uncertainty sources in radiopharmaceuticals clinical studies

    International Nuclear Information System (INIS)

    Degenhardt, Aemilie Louize; Oliveira, Silvia Maria Velasques de

    2014-01-01

    The radiopharmaceuticals should be approved for consumption by evaluating their quality, safety and efficacy. Clinical studies are designed to verify the pharmacodynamics, pharmacological and clinical effects in humans and are required for assuring safety and efficacy. The Bayesian analysis has been used for clinical studies effectiveness evaluation. This work aims to identify uncertainties associated with the process of production of the radionuclide and radiopharmaceutical labelling as well as the radiopharmaceutical administration and scintigraphy images acquisition and processing. For the development of clinical studies in the country, the metrological chain shall assure the traceability of the surveys performed in all phases. (author)

  20. Smartphone-based safety planning and self-monitoring for suicidal patients : Rationale and study protocol of the CASPAR (Continuous Assessment for Suicide Prevention And Research) study

    NARCIS (Netherlands)

    Nuij, Chani; van Ballegooijen, Wouter; Ruwaard, Jeroen; de Beurs, Derek; Mokkenstorm, Jan; van Duijn, Erik; de Winter, Remco F.P.; O'Connor, Rory C.; Smit, Jan H.; Riper, Heleen; Kerkhof, Ad

    2018-01-01

    Background: It remains difficult to predict and prevent suicidal behaviour, despite growing understanding of the aetiology of suicidality. Clinical guidelines recommend that health care professionals develop a safety plan in collaboration with their high-risk patients, to lower the imminent risk of

  1. Predicting the outcome of chronic kidney disease by the estimated nephron number: The rationale and design of PRONEP, a prospective, multicenter, observational cohort study

    Directory of Open Access Journals (Sweden)

    Imasawa Toshiyuki

    2012-03-01

    Full Text Available Abstract Background The nephron number is thought to be associated with the outcome of chronic kidney disease (CKD. If the nephron number can be estimated in the clinical setting, it could become a strong tool to predict renal outcome. This study was designed to estimate the nephron number in CKD patients and to establish a method to predict the outcome by using the estimated nephron number. Methods/Design The hypothesis of this study is that the estimated nephron number can predict the outcome of a CKD patient. This will be a multicenter, prospective (minimum 3 and maximum 5 years follow-up study. The subjects will comprise CKD patients aged over 14 years who have undergone a kidney biopsy. From January 2011 to March 2013, we will recruit 600 CKD patients from 10 hospitals belonging to the National Hospital Organization of Japan. The primary parameter for assessment is the composite of total mortality, renal death, cerebro-cardiovascular events, and a 50% reduction in the eGFR. The secondary parameter is the rate of eGFR decline per year. The nephron number will be estimated by the glomerular density in biopsy specimens and the renal cortex volume. This study includes one sub-cohort study to establish the equation to calculate the renal cortex volume. Enrollment will be performed at the time of the kidney biopsy, and the data will consist of a medical interview, ultrasound for measurement of the kidney size, blood or urine test, and the pathological findings of the kidney biopsy. Patients will continue to have medical consultations and receive examinations and/or treatment as usual. The data from the patients will be collected once a year after the kidney biopsy until March 2016. All data using this study are easily obtained in routine clinical practice. Discussion This study includes the first trials to estimate the renal cortex volume and nephron number in the general clinical setting. Furthermore, this is the first prospective study to

  2. Clinical studies of biomarkers in suicide prediction

    OpenAIRE

    Jokinen, Jussi

    2007-01-01

    Suicide is a major clinical problem in psychiatry and suicidal behaviours can be seen as a nosological entity per se. Predicting suicide is difficult due to its low base-rate and the limited specificity of clinical predictors. Prospective biological studies suggest that dysfunctions in the hypothalamo pituitary adrenal (HPA) axis and the serotonergic system have predictive power for suicide in mood disorders. Suicide attempt is the most robust clinical predictor making suici...

  3. CLINICAL STUDY OF DUODENAL PERFORATION

    Directory of Open Access Journals (Sweden)

    Sambasiva Rao

    2016-04-01

    Full Text Available BACKGROUND The duodenal injury can pose a formidable challenge to the surgeon and failure to manage it properly may have devastating results. Over the centuries, there was little to offer the patient of acute abdomen beyond cupping, purgation and enemas, all of which did more harm than good. It was not until 1884 that Mikulicz made an attempt to repair a perforation. Recent statistics indicate roughly 10% of population develop gastric or duodenal ulcer in life time. Roughly 1-3% of population above the age of 20 years have some degree of peptic ulcer activity during any annual period. A detailed history with regards to the signs and symptoms of the patient, a meticulous examination, radiological and biochemical investigations help to arrive at a correct preoperative diagnosis. In this study, a sincere effort has been put to understand the demographic patterns, to understand the underlying aetiology and to understand the effectiveness of the standard methods of investigation and treatment in use today. METHODS This is a 24 months prospective study i.e., from September 2011 to September 2013 carried out at Dr. Pinnamaneni Siddhartha Institute of Medical Sciences & Research Foundation. The study included the patients presenting to Dr. Pinnamaneni Siddhartha Institute of Medical Sciences & Research Foundation to emergency ward with signs and symptoms of hollow viscus perforation. The sample size included 30 cases of duodenal perforation. RESULTS Duodenal ulcer perforation commonly occurs in the age group of 30-60 years, but it can occur in any age group. Majority of the patients were male. Smoking and alcohol consumption were risk factors in most cases (53.3% for the causation of duodenal ulcer perforation. Sudden onset of abdominal pain, situated at epigastrium and right hypochondrium was a constant symptom (100%. Vomiting, constipation and fever were not so common. CONCLUSION The emergency surgical management for perforated duodenal ulcer is by

  4. CLINICAL STUDY OF CONCOMITANT SQUINT

    Directory of Open Access Journals (Sweden)

    Vijay Chopra

    2017-07-01

    Full Text Available BACKGROUND Malalignment in the visual axes of the two eyes is called strabismus. Fusion of both images is replaced either by diplopia or suppression of one image. Squint leads to loss of binocular single vision. Concomitant squint is a type of manifest squint in which the amount of deviation in the squinting eye is same in all gazes. Binocular single vision and ocular movement coordination are not present since birth, but are acquired in the early childhood. This process starts by the age of 3-6 months and is completed up to 5-6 years. Any hindrance in the development of these processes may result in concomitant squint. MATERIALS AND METHODS In 100 cases of concomitant squint, patients were included in our study. Detailed history was taken regarding the onset of squint and duration. Past history and family history was also elicited. General examination was done to detect any abnormalities of central nervous system. Routine ophthalmic examination including best corrected visual acuity, cover test performed to detect the type of deviation whether uniocular or alternating and the type of fixation. Angle of deviation was measured by Hirschberg’s test and on the synoptophore. Binocular single vision was assessed using Worth’s 4-dot test and synoptophore. Cycloplegic refraction and fundus evaluation done in all patients. Inclusion Criteria- All primary non-paralytic deviations, sensory deprivation strabismus. Exclusion Criteria- Paralytic strabismus, strabismus associated with neurological disorders, consecutive strabismus and palpebral fissure abnormalities patients. RESULTS Majority of cases of concomitant squint were of esotropic type. Most common form of esotropia seen was infantile esotropia. Most common form of exotropia was intermittent exotropia. 19% of cases were secondary to other ocular diseases namely cataract, macular lesion, high myopia, etc. Amblyopia was present in 54% patients and of very dense type, which could not be treated

  5. Korean Clinic Based Outcome Measure Studies

    OpenAIRE

    Jongbae Park

    2003-01-01

    Background: Evidence based medicine has become main tools for medical practice. However, conducting a highly ranked in the evidence hierarchy pyramid is not easy or feasible at all times and places. There remains a room for descriptive clinical outcome measure studies with admitting the limit of the intepretation. Aims: Presents three Korean clinic based outcome measure studies with a view to encouraging Korean clinicians to conduct similar studies. Methods: Three studies are presented...

  6. Clinical study of CT colonography

    International Nuclear Information System (INIS)

    Nakazawa, Saburo; Hattori, Toshiyuki; Inui, Kazuo

    2011-01-01

    We studied the usefulness of CT colonography (CTC) for colon cancer diagnosis. CTC and optical colonoscopy were performed for 150 cases mainly including patients with a positive fecal occult blood test (FOBT). The results were compared and analyzed. The following are the final diagnoses given to the patients: advanced colon cancer: 41 cases; early cancer: 25 cases; adenoma: 74 cases; hyperplasia: 3 cases; submucosal tumor: 1 case; and no lesion: 6 cases. In terms of diagnostic performance of CTC, accuracy was found to be 96%, sensitivity was found to be 97.9%, and specificity was found to be 50%. Cancer stage-specific sensitivity was as follows: advanced colon cancer: 100%; early cancer: 96.3%; adenoma: 71.2%; and hyperplasia: 47.4%. Lesion site-specific sensitivity was as follows: caecum: 76.2%; ascending colon: 57.6%; transverse colon: 66.2%; descending colon: 83.3%; sigmoid colon: 85.1%; and rectum: 78.0%. Lesion size-specific sensitivity was as follows: 2 to 5 mm: 56.7%; 6 to 9 mm: 88.1%; 10 mm or more: 92.5%; and 6 mm or more: 90.9%. Therefore, the diagnostic sensitivity of CTC was confirmed to be high. The results suggest that CTC would be useful for colon cancer screening. (author)

  7. Clinical studies on Bell's palsy

    International Nuclear Information System (INIS)

    Yamada, Yoshio

    1985-01-01

    The purpose of this study was to evaluate the diagnostic value of the salivary gland scintigraphy using sup(99m)Tc-pertechnetate for the prognosis of Bell's palsy. The salivary gland scintigraphy was performed in 40 patients with Bell's palsy and 15 normal subjects. After intravenous injection of 10 mCt of sup(99m)Tc-pertechnetate, sequential scintigrams were taken with a scintillation camera every one minute for 25 minutes. At 15 minutes after injection, both of normal subjects and patients were given ascorbic acid to stimulate the secretion of saliva. By the present method, the time activity curve was examined for the regions of interest over the parotid and submandibular glands and backgrounds. In normal subjects, values of the concentration and excretory ratio between the right and left sides of the parotid and submandibular glands were more than 80%. Some patients with Bell's palsy showed a decreased concentration and/or excretory ratio less than 80% between the normal and affected sides of the parotid glands. This suggests a functional involvement of the facial nerve in the salivary secretion from the parotid glands. On examination within 10 days of the onset of Bell's palsy, 31 cases with complete recovery showed values of the concentration ratio and/or excretory ratio more than 80% between the normal and affected sides of the submandibular glands. In contrast, 9 cases with imcomplete recovery showed low values of the concentration ratio and excretory ratio less than 80%. In the latter, more active treatments such as decompression operation should be considerd in the early stage of the palsy. The salivary scintigraphy using sup(99m)Tc-pertechnetate is more valuable as an early prognostic indicator for Bell's palsy compared with other prognostic tests such as the lid vibration test, the stapedial reflex test, the electrogustometry, the nerve excitability test and the evoked electromyography. (author)

  8. Rationale and design of XAMOS

    DEFF Research Database (Denmark)

    Turpie, Alexander G G; Schmidt, André C; Kreutz, Reinhold

    2012-01-01

    , noninterventional, parallel-group study to gain insight into the safety (major bleeding, side effects) and effectiveness (prevention of symptomatic thromboembolic events) of rivaroxaban in daily clinical practice. XAMOS will follow 15,000 patients after major orthopedic surgery in approximately 200 centers...

  9. Use of mobile devices and the internet for multimedia informed consent delivery and data entry in a pediatric asthma trial: Study design and rationale.

    Science.gov (United States)

    Blake, Kathryn; Holbrook, Janet T; Antal, Holly; Shade, David; Bunnell, H Timothy; McCahan, Suzanne M; Wise, Robert A; Pennington, Chris; Garfinkel, Paul; Wysocki, Tim

    2015-05-01

    Phase III/IV clinical trials are expensive and time consuming and often suffer from poor enrollment and retention rates. Pediatric trials are particularly difficult because scheduling around the parent, participant and potentially other sibling schedules can be burdensome. We are evaluating using the internet and mobile devices to conduct the consent process and study visits in a streamlined pediatric asthma trial. Our hypothesis is that these study processes will be non-inferior and will be less expensive compared to a traditional pediatric asthma trial. Parents and participants, aged 12 through 17 years, complete the informed consent process by viewing a multi-media website containing a consent video and study material in the streamlined trial. Participants are provided an iPad with WiFi and EasyOne spirometer for use during FaceTime visits and online twice daily symptom reporting during an 8-week run-in followed by a 12-week study period. Outcomes are compared with participants completing a similarly designed traditional trial comparing the same treatments within the same pediatric health-system. After 8 weeks of open-label Advair 250/50 twice daily, participants in both trial types are randomized to Advair 250/50, Flovent 250, or Advair 100/50 given 1 inhalation twice daily. Study staff track time spent to determine study costs. Participants have been enrolled in the streamlined and traditional trials and recruitment is ongoing. This project will provide important information on both clinical and economic outcomes for a novel method of conducting clinical trials. The results will be broadly applicable to trials of other diseases. Copyright © 2015 Elsevier Inc. All rights reserved.

  10. When Regional Innovation Policies Meet Policy Rationales and Evidence:

    DEFF Research Database (Denmark)

    Borrás, Susana; Jordana, Jacint

    regions, and to understand how rationales and evidence can be translated into policy-making. To this purpose, this paper develops a framework to study the extent to which regional innovation policies have changed during the past few years. Since the mid-2000s there has been an important development......In spite of recent advancements regarding regional innovation policy rationales and evidence, there are few analyses about the actual features of existing regional innovation policies. Nevertheless, a policy analysis perspective is important in order to recognise their distinctive patterns across...... of innovation policy rationales, advocating for more specialisation; likewise, greater data availability at the regional level has allowed more sophisticated assessment of innovation performance. Finally, the crisis since 2008 has had ravaging effects in some regions, with job losses and severe economic...

  11. When Regional Innovation Policies Meet Policy Rationales and Evidence

    DEFF Research Database (Denmark)

    Borrás, Susana; Jordana, Jacint

    2016-01-01

    regions, and to understand how rationales and evidence can be translated into policy-making. To this purpose, this paper develops a framework to study the extent to which regional innovation policies have changed during the past few years. Since the mid-2000s, there has been an important development......In spite of recent advancements regarding regional innovation policy rationales and evidence, there are few analyses about the actual features of existing regional innovation policies. Nevertheless, a policy analysis perspective is important in order to recognize their distinctive patterns across...... of innovation policy rationales, advocating for more specialization; likewise, greater data availability at the regional level has allowed more sophisticated assessment of innovation performance. Finally, the crisis since 2008 has had ravaging effects in some regions, with job losses and severe economic...

  12. Rationale and design of the CAPAMIS study: Effectiveness of pneumococcal vaccination against community-acquired pneumonia, acute myocardial infarction and stroke

    Directory of Open Access Journals (Sweden)

    Salsench Elisabet

    2010-01-01

    Full Text Available Abstract Background The 23-valent polysaccharide pneumococcal vaccine (PPV-23 is recommended for elderly and high-risk people, although its effectiveness is controversial. Some studies have reported an increasing risk of acute vascular events among patients with pneumonia, and a recent case-control study has reported a reduction in the risk of myocardial infarction among patients vaccinated with PPV-23. Given that animal experiments have shown that pneumococcal vaccination reduces the extent of atherosclerotic lesions, it has been hypothesized that PPV-23 could protect against acute vascular events by an indirect effect preventing pneumonia or by a direct effect on oxidized low-density lipoproteins. The main objective of this study is to evaluate the clinical effectiveness of PPV-23 in reducing the risk of pneumonia and acute vascular events (related or nonrelated with prior pneumonia in the general population over 60 years. Methods/Design Cohort study including 27,000 individuals 60 years or older assigned to nine Primary Care Centers in the region of Tarragona, Spain. According to the reception of PPV-23 before the start of the study, the study population will be divided into vaccinated and nonvaccinated groups, which will be followed during a consecutive 30-month period. Primary Care and Hospitals discharge databases will initially be used to identify study events (community-acquired pneumonia, hospitalisation for acute myocardial infarction and stroke, but all cases will be further validated by checking clinical records. Multivariable Cox regression analyses estimating hazard ratios (adjusted for age, sex and comorbidities will be used to estimate vaccine effectiveness. Discussion The results of the study will contribute to clarify the controversial effect of the PPV-23 in preventing community-acquired pneumonia and they will be critical in determining the posible role of pneumococcal vaccination in cardiovascular prevention.

  13. The rationale of scored tablets as dosage form.

    NARCIS (Netherlands)

    Rodenhuis, N.; Smet, P.A.G.M. de; Barends, D.M.

    2004-01-01

    The aim of the study was to get insight into the rationale of scored tablets. This was pursued by studying patient's reasons for subdividing ("breaking") scored and unscored tablets. Patients who picked up their prescriptions in 5 community pharmacies in The Netherlands were questioned. Two-hundred

  14. Meeting a Moral Imperative: A Rationale for Teaching the Holocaust

    Science.gov (United States)

    Lindquist, David H.

    2011-01-01

    A primary rationale for studying the Holocaust (Shoah) involves the opportunity to consider the moral implications that can be drawn from examining the event. Studying the Shoah forces students to consider what it means to be human and humane by examining the full continuum of individual behavior, from "ultimate evil" to "ultimate good". This…

  15. Advances in clinical study of curcumin.

    Science.gov (United States)

    Yang, Chunfen; Su, Xun; Liu, Anchang; Zhang, Lin; Yu, Aihua; Xi, Yanwei; Zhai, Guangxi

    2013-01-01

    Curcumin has been estimated as a potential agent for many diseases and attracted great attention owing to its various pharmacological activities, including anti-cancer, and anti-inflammatory. Now curcumin is being applied to a number of patients with breast cancer, rheumatoid arthritis, Alzheimer's disease, colorectal cancer, psoriatic, etc. Several clinical trials have stated that curcumin is safe enough and effective. The objective of this article was to summarize the clinical studies of curcumin, and give a reference for future studies.

  16. Effect of caffeine on SPECT myocardial perfusion imaging during regadenoson pharmacologic stress: rationale and design of a prospective, randomized, multicenter study.

    Science.gov (United States)

    Tejani, Furqan H; Thompson, Randall C; Iskandrian, Ami E; McNutt, Bruce E; Franks, Billy

    2011-02-01

    Caffeine attenuates the coronary hyperemic response to adenosine by competitive A₂(A) receptor blockade. This study aims to determine whether oral caffeine administration compromises diagnostic accuracy in patients undergoing vasodilator stress myocardial perfusion imaging (MPI) with regadenoson, a selective adenosine A(2A) agonist. This multicenter, randomized, double-blind, placebo-controlled, parallel-group study includes patients with suspected coronary artery disease who regularly consume caffeine. Each participant undergoes three SPECT MPI studies: a rest study on day 1 (MPI-1); a regadenoson stress study on day 3 (MPI-2), and a regadenoson stress study on day 5 with double-blind administration of oral caffeine 200 or 400 mg or placebo capsules (MPI-3; n = 90 per arm). Only participants with ≥ 1 reversible defect on the second MPI study undergo the subsequent stress MPI test. The primary endpoint is the difference in the number of reversible defects on the two stress tests using a 17-segment model. Pharmacokinetic/pharmacodynamic analyses will evaluate the effect of caffeine on the regadenoson exposure-response relationship. Safety will also be assessed. The results of this study will show whether the consumption of caffeine equivalent to 2-4 cups of coffee prior to an MPI study with regadenoson affects the diagnostic validity of stress testing (ClinicalTrials.gov number, NCT00826280).

  17. Rationale and methods of the EFCOSUM project

    NARCIS (Netherlands)

    Brussaard, J.H.; Johansson, L.; Kearney, J.

    2002-01-01

    Objective: To describe the rationale and methods for a European project (EFCOSUM) to develop a method for a European food consumption survey that delivers internationally comparable data on a set of policy-relevant nutritional indicators. Rationale and methods: Currently Member States are collecting

  18. International Study on Syncope of Uncertain Etiology 2: the management of patients with suspected or certain neurally mediated syncope after the initial evaluation Rationale and study design

    NARCIS (Netherlands)

    Brignole, M.; Sutton, R.; Menozzi, C.; Moya, A.; Garcia-Civera, R.; Benditt, D.; Vardas, P.; Wieling, W.; Andresen, D.; Migliorini, R.; Hollinworth, D.

    2003-01-01

    Study design Multi-centre, prospective observational study Objectives Main objective is to verify the value of implantable loop recorder (ILR) in assessing the mechanism of syncope and the efficacy of the ILR-guided therapy after syncope recurrence. Inclusion criteria Patients who met the following

  19. Clinically unrecognized miliary tuberculosis: an autopsy study.

    Science.gov (United States)

    Savic, Ivana; Trifunovic-Skodric, Vesna; Mitrovic, Dragan

    2016-01-01

    Miliary tuberculosis (TB) usually presents with atypical clinical manifestations; thus it is often recognized only at autopsy. Our objectives were to study the frequency of MT diagnosed at autopsy and determine clinical diagnoses that masked TB, as well as causes of death and comorbidities. Retrospective study of all autopsies performed between 2008 and 2014. Institute of Pathology, Belgrade, Serbia. in subjects where autopsy showed the presence of MT that was not recognized clinically, we recorded the clinical diagnoses (presumed causes of death) as reported in autopsy request forms, as well as actual cause of death and comorbidities as determined at autopsy. Clinically unrecognized MT. The total number of autopsies in this period was 6206. thirty-five individuals showed clinically unrecognized MT (0.56% of all autopsies, age: 62.2 [17.2] years, M:F=2:3). Common clinical diagnoses masking pulmonary MT were exacerbation of COPD (25%) and pulmonary thromboembolism (25%), with common radiological presentation of diffuse pulmonary infiltrates (56.3%). Dominant clinical diagnoses in patients with generalized MT were adult respiratory distress syndrome, sepsis, gastrointestinal bleeding and meningoencephalitis. Disseminated MT was often associated with secondary anemia or thrombocytopenia (15.8%) and recent surgery (15.8%). Frequent comorbidities included chronic renal failure and malignancies, whereas MT was a dominant cause of death. Greater awareness of MT is needed to improve recognition in clinical settings. In particular, MT should be considered in patients with atypical clinical presentation and diffuse pulmonary infiltrates on chest X-ray, particularly if they have chronic renal failure, malignancy, hematological disorders or a history of recent surgery. None.

  20. Rationale and design of MUSIC OS-EU: an international observational study of the treatment of postmenopausal women for osteoporosis in Europe and Canada.

    Science.gov (United States)

    Modi, Ankita; Sen, Shuvayu; Adachi, Jonathan D; Adami, Silvano; Cortet, Bernard; Cooper, Alun L; Geusens, Piet; Mellström, Dan; Weaver, Jessica P; van den Bergh, Joop P; Nguyen, Allison M; Keown, Paul A; Leung, Albert T; Sajjan, Shiva

    2015-01-01

    The Medication Use Patterns, Treatment Satisfaction, and Inadequate Control of Osteoporosis Study (MUSIC OS-EU) was designed to better understand the rate and burden of gastrointestinal (GI) events on clinical and health care outcomes among postmenopausal women with osteoporosis. MUSIC OS-EU is a prospective, multinational, observational cohort study of postmenopausal women ≥50 years of age diagnosed with osteoporosis and enrolled in physician clinics in six countries: France, Italy, the Netherlands, Sweden, the United Kingdom, and Canada. The MUSIC OS-EU study has three components: (i) a physician survey to describe their management of osteoporotic patients with GI events; (ii) a retrospective chart survey to describe the receipt and type of osteoporosis medication prescribed; and (iii) a prospective cohort study including untreated and treated patients diagnosed with osteoporosis to investigate the rate of GI events and association with osteoporosis medication use patterns, health-related quality of life, treatment satisfaction and resource utilisation among postmenopausal women with osteoporosis. Physicians at 97 sites completed the physician questionnaire and data for 716 patients were abstracted for the retrospective chart review. Enrolment and the baseline data collection for the prospective cohort study were conducted between March 2012 and June 2013 for 292 untreated and 2,959 treated patients, of whom 684 were new users and 2,275 were experienced users of oral osteoporosis medications. The results of MUSIC OS-EU will illuminate the association of GI events with the management of osteoporosis and with patient-reported outcomes among postmenopausal women with osteoporosis in Europe and Canada.

  1. Enhancing field GP engagement in hospital-based studies. Rationale, design, main results and participation in the diagest 3-GP motivation study

    Directory of Open Access Journals (Sweden)

    Berkhout Christophe

    2012-06-01

    Full Text Available Abstract Background Diagest 3 was a study aimed at lowering the risk of developing type 2 diabetes within 3 years after childbirth. Women with gestational diabetes were enrolled in the study. After childbirth, the subjects showed little interest in the structured education programme and did not attend workshops. Their general practitioners (GPs were approached to help motivate the subjects to participate in Diagest 3, but the GPs were reluctant. The present study aimed to understand field GPs’ attitudes towards hospital-based studies, and to develop strategies to enhance their involvement and reduce subject drop-out rates. Methods We used a three-step process: step one used a phenomenological approach exploring the beliefs, attitudes, motivations and environmental factors contributing to the GPs’ level of interest in the study. Data were collected in face-to-face interviews and coded by hand and with hermeneutic software to develop distinct GP profiles. Step two was a cross-sectional survey by questionnaire to determine the distribution of the profiles in the GP study population and whether completion of an attached case report form (CRF was associated with a particular GP profile. In step three, we assessed the impact of the motivation study on participation rates in the main study. Results Fifteen interviews were conducted to achieve data saturation. Theorisation led to the definition of 4 distinct GP profiles. The response rate to the questionnaire was 73%, but dropped to 52% when a CRF was attached. The link between GP profiles and the rate of CRF completion remains to be verified. The GPs provided data on the CRF that was of comparable quality to those collected in the main trial. Our analysis showed that the motivation study increased overall participation in the main study by 23%, accounting for 16% (24/152 of all final visits for 536 patients who were initially enrolled in the Diagest 3 study. Conclusions When a hospital-led study

  2. Enhancing field GP engagement in hospital-based studies. Rationale, design, main results and participation in the Diagest 3-GP motivation study.

    Science.gov (United States)

    Berkhout, Christophe; Vandaele-Bétancourt, Marie; Robert, Stéphane; Lespinasse, Solène; Mitha, Gamil; Bradier, Quentin; Vambergue, Anne; Fontaine, Pierre

    2012-06-21

    Diagest 3 was a study aimed at lowering the risk of developing type 2 diabetes within 3 years after childbirth. Women with gestational diabetes were enrolled in the study. After childbirth, the subjects showed little interest in the structured education programme and did not attend workshops. Their general practitioners (GPs) were approached to help motivate the subjects to participate in Diagest 3, but the GPs were reluctant. The present study aimed to understand field GPs' attitudes towards hospital-based studies, and to develop strategies to enhance their involvement and reduce subject drop-out rates. We used a three-step process: step one used a phenomenological approach exploring the beliefs, attitudes, motivations and environmental factors contributing to the GPs' level of interest in the study. Data were collected in face-to-face interviews and coded by hand and with hermeneutic software to develop distinct GP profiles. Step two was a cross-sectional survey by questionnaire to determine the distribution of the profiles in the GP study population and whether completion of an attached case report form (CRF) was associated with a particular GP profile. In step three, we assessed the impact of the motivation study on participation rates in the main study. Fifteen interviews were conducted to achieve data saturation. Theorisation led to the definition of 4 distinct GP profiles. The response rate to the questionnaire was 73%, but dropped to 52% when a CRF was attached. The link between GP profiles and the rate of CRF completion remains to be verified. The GPs provided data on the CRF that was of comparable quality to those collected in the main trial. Our analysis showed that the motivation study increased overall participation in the main study by 23%, accounting for 16% (24/152) of all final visits for 536 patients who were initially enrolled in the Diagest 3 study. When a hospital-led study explores issues in primary care, its design must anticipate GP

  3. Rationale and design of three observational, prospective cohort studies including biobanking to evaluate and improve diagnostics, management strategies and risk stratification in venous thromboembolism: the VTEval Project.

    Science.gov (United States)

    Frank, Bernd; Ariza, Liana; Lamparter, Heidrun; Grossmann, Vera; Prochaska, Jürgen H; Ullmann, Alexander; Kindler, Florentina; Weisser, Gerhard; Walter, Ulrich; Lackner, Karl J; Espinola-Klein, Christine; Münzel, Thomas; Konstantinides, Stavros V; Wild, Philipp S

    2015-07-01

    Venous thromboembolism (VTE) with its two manifestations deep vein thrombosis (DVT) and pulmonary embolism (PE) is a major public health problem. The VTEval Project aims to investigate numerous research questions on diagnosis, clinical management, treatment and prognosis of VTE, which have remained uncertain to date. The VTEval Project consists of three observational, prospective cohort studies on VTE comprising cohorts of individuals with a clinical suspicion of acute PE (with or without DVT), with a clinical suspicion of acute DVT (without symptomatic PE) and with an incidental diagnosis of VTE (PE or DVT). The VTEval Project expects to enrol a total of approximately 2000 individuals with subsequent active and passive follow-up investigations over a time period of 5 years per participant. Time points for active follow-up investigations are at months 3, 6, 12, 24 and 36 after diagnosis (depending on the disease cohort); passive follow-up investigations via registry offices and the cancer registry are performed 48 and 60 months after diagnosis for all participants. Primary short-term outcome is defined by overall mortality (PE-related death and all other causes of death), primary long-term outcome by symptomatic VTE (PE-related death, recurrence of non-fatal PE or DVT). The VTEval Project includes three 'all-comer' studies and involves the standardised acquisition of high-quality data, covering the systematic assessment of VTE including symptoms, risk profile, psychosocial, environmental and lifestyle factors as well as clinical and subclinical disease, and it builds up a large state-of-the-art biorepository containing various materials from serial blood samplings. The VTEval Project has been approved by the local data safety commissioner and the responsible ethics committee (reference no. 837.320.12 (8421-F)). Trial results will be published in peer-reviewed journals and presented at national and international scientific meetings. NCT02156401. Published by the

  4. Treatment of anxiety in patients with coronary heart disease: Rationale and design of the UNderstanding the benefits of exercise and escitalopram in anxious patients WIth coroNary heart Disease (UNWIND) randomized clinical trial.

    Science.gov (United States)

    Blumenthal, James A; Feger, Bryan J; Smith, Patrick J; Watkins, Lana L; Jiang, Wei; Davidson, Jonathan; Hoffman, Benson M; Ashworth, Megan; Mabe, Stephanie K; Babyak, Michael A; Kraus, William E; Hinderliter, Alan; Sherwood, Andrew

    2016-06-01

    Anxiety is highly prevalent among patients with coronary heart disease (CHD), and there is growing evidence that high levels of anxiety are associated with worse prognosis. However, few studies have evaluated the efficacy of treating anxiety in CHD patients for reducing symptoms and improving clinical outcomes. Exercise and selective serotonin reuptake inhibitors have been shown to be effective in treating patients with depression, but have not been studied in cardiac patients with high anxiety. The UNWIND trial is a randomized clinical trial of patients with CHD who are at increased risk for adverse events because of comorbid anxiety. One hundred fifty participants with CHD and elevated anxiety symptoms and/or with a diagnosed anxiety disorder will be randomly assigned to 12 weeks of aerobic exercise (3×/wk, 35 min, 70%-85% VO2peak), escitalopram (5-20 mg qd), or placebo. Before and after 12 weeks of treatment, participants will undergo assessments of anxiety symptoms and CHD biomarkers of risk, including measures of inflammation, lipids, hemoglobin A1c, heart rate variability, and vascular endothelial function. Primary outcomes include post-intervention effects on symptoms of anxiety and CHD biomarkers. Secondary outcomes include clinical outcomes (cardiovascular hospitalizations and all-cause death) and measures of quality of life. The UNWIND trial (ClinicalTrials.gov NCT02516332) will evaluate the efficacy of aerobic exercise and escitalopram for improving anxiety symptoms and reducing risk for adverse clinical events in anxious CHD patients. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. Talocalcaneal luxation: an anatomic and clinical study

    International Nuclear Information System (INIS)

    Gorse, M.J.; Purinton, P.T.; Penwick, R.C.; Aron, D.N.; Roberts, R.E.

    1990-01-01

    Talocalcaneal luxation in dogs was studied by anatomic dissection of the talocalcaneal joint in cadavers and review of five clinical cases. The integrity of the talocalcaneal joint was maintained by two strong ligaments traversing the tarsal sinus between the two bones. The joint was found to be a low motion joint. Luxation in clinical cases was not always apparent on standard radiographic views. Three dogs were treated surgically with a screw inserted in lag fashion from talus to calcaneus. One luxation was treated surgically with figure-of-eight orthopedic wires and one was treated with external coaptation. Four dogs returned to their previous levels of function without clinically detectable lameness

  6. A Community-Based Intervention to Prevent Obesity Beginning at Birth among American Indian Children: Study Design and Rationale for the PTOTS Study

    Science.gov (United States)

    Karanja, Njeri; Aickin, Mikel; Lutz, Tam; Mist, Scott; Jobe, Jared B.; Maupome, Gerardo; Ritenbaugh, Cheryl

    2012-01-01

    Eating and physical activity behaviors associated with adult obesity have early antecedents, yet few studies have focused on obesity prevention interventions targeting very young children. Efforts to prevent obesity beginning at birth seem particularly important in populations at risk for early-onset obesity. National estimates indicate that…

  7. Rationale and Design of a Randomized Clinical Comparison of Everolimus-Eluting (Xience V/Promus) and Sirolimus-Eluting (Cypher Select+) Coronary Stents in Unselected Patients with Coronary Heart Disease

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Tilsted, Hans Henrik

    2010-01-01

    with Clinical Outcome (SORT OUT) IV trial was designed as a prospective, multi-center, open-label, all-comer, two-arm, randomized, non-inferiority study comparing the everolimus-eluting stent with the sirolimus-eluting stent in the treatment of atherosclerotic coronary artery lesions. Based on a non...

  8. Rationales behind the choice of administration form with fentanyl

    DEFF Research Database (Denmark)

    Jacobsen, Ramune; Møldrup, Claus; Christrup, Lona

    2010-01-01

    BACKGROUND AND AIM: The aim of this study was to describe the rationale behind the choice of fentanyl administration forms among Danish general practitioners (GPs). METHODS: Thirty-eight Danish GPs were contacted via an Internet survey system to perform a Delphi survey. In the brainstorming phase...

  9. Rationale and design for cognitive behavioral therapy for anxiety disorders in children with autism spectrum disorder: a study protocol of a randomized controlled trial.

    Science.gov (United States)

    Kilburn, Tina R; Sørensen, Merete Juul; Thastum, Mikael; Rapee, Ronald M; Rask, Charlotte Ulrikka; Arendt, Kristian Bech; Thomsen, Per Hove

    2018-04-02

    Autism spectrum disorder (ASD) is found in approximately 1% of the population and includes core symptoms that affect general and social development. Beside these core symptoms, it is suggested that up to 60% of children with ASD suffer from comorbid anxiety disorders which may further affect educational, social and general development as well as quality of life. The main goal of this study is to examine the effectiveness of a manualized cognitive behavioral therapy (CBT) anxiety program adapted for children with ASD. This study is a randomized controlled trial (RCT). Fifty children with ASD and anxiety, aged 7 to 13 years, will be randomly assigned to group CBT or a wait-list control (WL) condition. The design will follow a two (CBT and WL) by two (pre-post assessment) mixed between-within design. The control group will receive intervention after the waitlist period of 13 weeks. Primary outcomes are diagnostic status and severity of the anxiety disorders, measured with The Anxiety Disorder Interview Schedule for DSM-IV, Parent and Child Versions. Secondary outcomes are parent and child ratings on questionnaires on the child's level of anxiety and impact on everyday life. Additional outcomes entail information gathered from parents, child and teachers on the child's behavior and negative self-statements, together with social and adaptive skills. Follow-up data will be collected 3 months after intervention. This study aims to evaluate the effectiveness of a manualized CBT program in Danish children with ASD and anxiety within a mental health clinic setting. The hypothesis is that training anxiety reduction skills will decrease anxiety in children, as well as ensure better psychosocial development for the child in general. https://ClinicalTrials.gov ( NCT02908321 ). Registered 19th of September 2016.

  10. Rationale, Design, and Methodological Aspects of the BUDAPEST-GLOBAL Study (Burden of Atherosclerotic Plaques Study in Twins-Genetic Loci and the Burden of Atherosclerotic Lesions).

    Science.gov (United States)

    Maurovich-Horvat, Pál; Tárnoki, Dávid L; Tárnoki, Ádám D; Horváth, Tamás; Jermendy, Ádám L; Kolossváry, Márton; Szilveszter, Bálint; Voros, Viktor; Kovács, Attila; Molnár, Andrea Á; Littvay, Levente; Lamb, Hildo J; Voros, Szilard; Jermendy, György; Merkely, Béla

    2015-12-01

    The heritability of coronary atherosclerotic plaque burden, coronary geometry, and phenotypes associated with increased cardiometabolic risk are largely unknown. The primary aim of the Burden of Atherosclerotic Plaques Study in Twins-Genetic Loci and the Burden of Atherosclerotic Lesions (BUDAPEST-GLOBAL) study is to evaluate the influence of genetic and environmental factors on the burden of coronary artery disease. By design this is a prospective, single-center, classical twin study. In total, 202 twins (61 monozygotic pairs, 40 dizygotic same-sex pairs) were enrolled from the Hungarian Twin Registry database. All twins underwent non-contrast-enhanced computed tomography (CT) for the detection and quantification of coronary artery calcium and for the measurement of epicardial fat volumes. In addition, a single non-contrast-enhanced image slice was acquired at the level of L3-L4 to assess abdominal fat distribution. Coronary CT angiography was used for the detection and quantification of plaque, stenosis, and overall coronary artery disease burden. For the primary analysis, we will assess the presence and volume of atherosclerotic plaques. Furthermore, the 3-dimensional coronary geometry will be assessed based on the coronary CT angiography datasets. Additional phenotypic analyses will include per-patient epicardial and abdominal fat quantity measurements. Measurements obtained from monozygotic and dizygotic twin pairs will be compared to evaluate the genetic or environmental effects of the given phenotype. The BUDAPEST-GLOBAL study provides a unique framework to shed some light on the genetic and environmental influences of cardiometabolic disorders. © 2015 Wiley Periodicals, Inc.

  11. The Canadian HIV and aging cohort study - determinants of increased risk of cardio-vascular diseases in HIV-infected individuals: rationale and study protocol.

    Science.gov (United States)

    Durand, Madeleine; Chartrand-Lefebvre, Carl; Baril, Jean-Guy; Trottier, Sylvie; Trottier, Benoit; Harris, Marianne; Walmsley, Sharon; Conway, Brian; Wong, Alexander; Routy, Jean-Pierre; Kovacs, Colin; MacPherson, Paul A; Monteith, Kenneth Marc; Mansour, Samer; Thanassoulis, George; Abrahamowicz, Michal; Zhu, Zhitong; Tsoukas, Christos; Ancuta, Petronela; Bernard, Nicole; Tremblay, Cécile L

    2017-09-11

    With potent antiretroviral drugs, HIV infection is becoming a chronic disease. Emergence of comorbidities, particularly cardiovascular disease (CVD) has become a leading concern for patients living with the infection. We hypothesized that the chronic and persistent inflammation and immune activation associated with HIV disease leads to accelerated aging, characterized by CVD. This will translate into higher incidence rates of CVD in HIV infected participants, when compared to HIV negative participants, after adjustment for traditional CVD risk factors. When characterized further using cardiovascular imaging, biomarkers, immunological and genetic profiles, CVD associated with HIV will show different characteristics compared to CVD in HIV-negative individuals. The Canadian HIV and Aging cohort is a prospective, controlled cohort study funded by the Canadian Institutes of Health Research. It will recruit patients living with HIV who are aged 40 years or older or have lived with HIV for 15 years or more. A control population, frequency matched for age, sex, and smoking status, will be recruited from the general population. Patients will attend study visits at baseline, year 1, 2, 5 and 8. At each study visit, data on complete medical and pharmaceutical history will be captured, along with anthropometric measures, a complete physical examination, routine blood tests and electrocardiogram. Consenting participants will also contribute blood samples to a research biobank. The primary outcome is incidence of a composite of: myocardial infarction, coronary revascularization, stroke, hospitalization for angina or congestive heart failure, revascularization or amputation for peripheral artery disease, or cardiovascular death. Preplanned secondary outcomes are all-cause mortality, incidence of the metabolic syndrome, incidence of type 2 diabetes, incidence of renal failure, incidence of abnormal bone mineral density and body fat distribution. Patients participating to the

  12. Public control of environmental health hazards (clinical and experimental studies of distal axonopathy--a frequent form of brain and nerve damage produced by environmental chemical hazards)

    Energy Technology Data Exchange (ETDEWEB)

    Schaumburg, H.H.; Spencer, P.S.

    1979-01-01

    Clinical and pathological studies of the peripheral and central nervous system degeneration (distal dying-back axonopathy) in humans and experimental animals produced by acrylamide monomer and certain hydrocarbon compounds are summarized. The human distal axonopathies include: many of the naturally occurring, genetically determined system disorders/ certain nutritional disorders/ uremic neuropathy/ the neuropathies associated with some malignancies/ and the toxic neuropathies induced by industrial chemicals. The irreversible, subclinical, and clinical effects of distal axonopathies on the human central nervous system are examined. A morphological rationale for previously enigmatic clinical phenomena in the human toxic neuropathies is presented. Neuropathology is potentially useful in the screening of chemicals for neurotoxicity. (7 photos, 24 references)

  13. Enhancing physical and social environments to reduce obesity among public housing residents: rationale, trial design, and baseline data for the Healthy Families study.

    Science.gov (United States)

    Quintiliani, Lisa M; DeBiasse, Michele A; Branco, Jamie M; Bhosrekar, Sarah Gees; Rorie, Jo-Anna L; Bowen, Deborah J

    2014-11-01

    Intervention programs that change environments have the potential for greater population impact on obesity compared to individual-level programs. We began a cluster randomized, multi-component multi-level intervention to improve weight, diet, and physical activity among low-socioeconomic status public housing residents. Here we describe the rationale, intervention design, and baseline survey data. After approaching 12 developments, ten were randomized to intervention (n=5) or assessment-only control (n=5). All residents in intervention developments are welcome to attend any intervention component: health screenings, mobile food bus, walking groups, cooking demonstrations, and a social media campaign; all of which are facilitated by community health workers who are residents trained in health outreach. To evaluate weight and behavioral outcomes, a subgroup of female residents and their daughters age 8-15 were recruited into an evaluation cohort. In total, 211 households completed the survey (RR=46.44%). Respondents were Latino (63%), Black (24%), and had ≤ high school education (64%). Respondents reported ≤2 servings of fruits & vegetables/day (62%), visiting fast food restaurants 1+ times/week (32%), and drinking soft drinks daily or more (27%). The only difference between randomized groups was race/ethnicity, with more Black residents in the intervention vs. control group (28% vs. 19%, p=0.0146). Among low-socioeconomic status urban public housing residents, we successfully recruited and randomized families into a multi-level intervention targeting obesity. If successful, this intervention model could be adopted in other public housing developments or entities that also employ community health workers, such as food assistance programs or hospitals. Copyright © 2014 Elsevier Inc. All rights reserved.

  14. Rationale, design, and methods for Canadian alliance for healthy hearts and minds cohort study (CAHHM – a Pan Canadian cohort study

    Directory of Open Access Journals (Sweden)

    Sonia S. Anand

    2016-07-01

    Full Text Available Abstract Background The Canadian Alliance for Healthy Hearts and Minds (CAHHM is a pan-Canadian, prospective, multi-ethnic cohort study being conducted in Canada. The overarching objective of the CAHHM is to understand the association of socio-environmental and contextual factors (such as societal structure, activity, nutrition, social and tobacco environments, and access to health services with cardiovascular risk factors, subclinical vascular disease, and cardiovascular and other chronic disease outcomes. Methods/Design Participants between 35 and 69 years of age are being recruited from existing cohorts and a new First Nations Cohort to undergo a detailed assessment of health behaviours (including diet and physical activity, cognitive function, assessment of their local home and workplace environments, and their health services access and utilization. Physical measures including weight, height, waist/hip circumference, body fat percentage, and blood pressure are collected. In addition, eligible participants undergo magnetic resonance imaging (MRI of the brain, heart, carotid artery and abdomen to detect early subclinical vascular disease and ectopic fat deposition. Discussion CAHHM is a prospective cohort study designed to investigate the impact of community level factors, individual health behaviours, and access to health services, on cognitive function, subclinical vascular disease, fat distribution, and the development of chronic diseases among adults living in Canada.

  15. A Community-Based Intervention to Prevent Obesity Beginning at Birth among American Indian Children: Study Design and Rationale for the PTOTS study

    Science.gov (United States)

    Karanja, Njeri; Aickin, Mikel; Lutz, Tam; Mist, Scott; Jobe, Jared B.; Maupomé, Gerardo; Ritenbaugh, Cheryl

    2012-01-01

    Eating and physical activity behaviors associated with adult obesity have early antecedents, yet few studies have focused on obesity prevention interventions targeting very young children. Efforts to prevent obesity beginning at birth seem particularly important in populations at risk for early-onset obesity. National estimates indicate that American Indian (AI) children have higher rates of overweight and obesity than children of other races/ethnicities. The Prevention of Toddler Obesity and Teeth Health Study (PTOTS) is a community-partnered randomized controlled trial designed to prevent obesity beginning at birth in AI children. PTOTS was developed to test the effectiveness of a multi-component intervention designed to: promote breastfeeding, reduce sugar-sweetened beverage consumption, appropriately time the introduction of healthy solid foods, and counsel parents to reduce sedentary lifestyles in their children. A birth cohort of 577 children from five AI tribes is randomized by tribe to either the intervention (three tribes) or the comparison condition (two tribes). The strengths and weaknesses of PTOTS include a focus on a critical growth phase, placement in the community, and intervention at many levels, using a variety of approaches. PMID:23001689

  16. Preventing AVF thrombosis: the rationale and design of the Omega-3 fatty acids (Fish Oils and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED study

    Directory of Open Access Journals (Sweden)

    Rosman Johan

    2009-01-01

    Full Text Available Abstract Background Haemodialysis (HD is critically dependent on the availability of adequate access to the systemic circulation, ideally via a native arteriovenous fistula (AVF. The Primary failure rate of an AVF ranges between 20–54%, due to thrombosis or failure of maturation. There remains limited evidence for the use of anti-platelet agents and uncertainty as to choice of agent(s for the prevention of AVF thrombosis. We present the study protocol for a randomised, double-blind, placebo-controlled, clinical trial examining whether the use of the anti-platelet agents, aspirin and omega-3 fatty acids, either alone or in combination, will effectively reduce the risk of early thrombosis in de novo AVF. Methods/Design The study population is adult patients with stage IV or V chronic kidney disease (CKD currently on HD or where HD is planned to start within 6 months in whom a planned upper or lower arm AVF is to be the primary HD access. Using a factorial-design trial, patients will be randomised to aspirin or matching placebo, and also to omega-3 fatty acids or matching placebo, resulting in four treatment groups (aspirin placebo/omega-3 fatty acid placebo, aspirin/omega-3 fatty acid placebo, aspirin placebo/omega-3 fatty acid, aspirin/omega-3 fatty acid. Randomisation will be achieved using a dynamic balancing method over the two stratification factors of study site and upper versus lower arm AVF. The medication will be commenced pre-operatively and continued for 3 months post surgery. The primary outcome is patency of the AVF at three months after randomisation. Secondary outcome measures will include functional patency at six and twelve months, primary patency time, secondary (assisted patency time, and adverse events, particularly bleeding. Discussion This multicentre Australian and New Zealand study has been designed to determine whether the outcome of surgery to create de novo AVF can be improved by the use of aspirin and/or omega-3 fatty

  17. Preventing AVF thrombosis: the rationale and design of the Omega-3 fatty acids (Fish Oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study.

    Science.gov (United States)

    Irish, Ashley; Dogra, Gursharan; Mori, Trevor; Beller, Elaine; Heritier, Stephane; Hawley, Carmel; Kerr, Peter; Robertson, Amanda; Rosman, Johan; Paul-Brent, Peta-Anne; Starfield, Melissa; Polkinghorne, Kevan; Cass, Alan

    2009-01-21

    Haemodialysis (HD) is critically dependent on the availability of adequate access to the systemic circulation, ideally via a native arteriovenous fistula (AVF). The Primary failure rate of an AVF ranges between 20-54%, due to thrombosis or failure of maturation. There remains limited evidence for the use of anti-platelet agents and uncertainty as to choice of agent(s) for the prevention of AVF thrombosis. We present the study protocol for a randomised, double-blind, placebo-controlled, clinical trial examining whether the use of the anti-platelet agents, aspirin and omega-3 fatty acids, either alone or in combination, will effectively reduce the risk of early thrombosis in de novo AVF. The study population is adult patients with stage IV or V chronic kidney disease (CKD) currently on HD or where HD is planned to start within 6 months in whom a planned upper or lower arm AVF is to be the primary HD access. Using a factorial-design trial, patients will be randomised to aspirin or matching placebo, and also to omega-3 fatty acids or matching placebo, resulting in four treatment groups (aspirin placebo/omega-3 fatty acid placebo, aspirin/omega-3 fatty acid placebo, aspirin placebo/omega-3 fatty acid, aspirin/omega-3 fatty acid). Randomisation will be achieved using a dynamic balancing method over the two stratification factors of study site and upper versus lower arm AVF. The medication will be commenced pre-operatively and continued for 3 months post surgery. The primary outcome is patency of the AVF at three months after randomisation. Secondary outcome measures will include functional patency at six and twelve months, primary patency time, secondary (assisted) patency time, and adverse events, particularly bleeding. This multicentre Australian and New Zealand study has been designed to determine whether the outcome of surgery to create de novo AVF can be improved by the use of aspirin and/or omega-3 fatty acids. Recently a placebo-controlled trial has shown that

  18. Rationale and Methodology for a Community-Based Study of Diabetic Retinopathy in an Indonesian Population with Type 2 Diabetes Mellitus: The Jogjakarta Eye Diabetic Study in the Community.

    Science.gov (United States)

    Sasongko, Muhammad B; Agni, Angela N; Wardhana, Firman S; Kotha, Satya P; Gupta, Prateek; Widayanti, Tri W; Supanji; Widyaputri, Felicia; Widyaningrum, Rifa; Wong, Tien Y; Kawasaki, Ryo; Wang, Jie Jin; Pawiroranu, Suhardjo

    2017-02-01

    There are no available data about diabetic retinopathy (DR) in the Indonesian population. This report summarizes the rationale and study design of the Jogjakarta Eye Diabetic Study in the Community (JOGED.COM), a community-based study to estimate the prevalence and risk factors of DR in persons with type 2 diabetes in Jogjakarta, Indonesia. The JOGED.COM aimed to examine a cross-sectional sample of 1200 persons with type 2 diabetes aged 30 years and older residing in the study area. We identified 121 community health centers (CHCs) in Jogjakarta and listed 35 CHCs with non-communicable diseases facilities. Multi-stage, clustered random sampling was used to select 22 CHCs randomly. We included CHCs with coverage population >30,000, and excluded those classified as 100% rural. Lists of persons with diabetes confirmed by their family physician were provided from each CHC. Examinations procedures included detailed interviews, general and eye examinations, anthropometry and body composition scan, and dilated fundus photography. We collaborated with local health authorities, family physicians, and local health practitioners in the recruitment phase. A total of 1435 invitations were distributed, and 1184 people (82.5%) with type 2 diabetes participated in this study, of whom 1138 (79.3%) had completed data with gradable retinal images. JOGED.COM is the first epidemiologic study of DR in an Indonesian population. This study will provide key information about the prevalence and risk factors of DR in the community. These data are very important for future health promotion programs to reduce the burden of DR in the population.

  19. The Alberta population-based prospective evaluation of the quality of life outcomes and economic impact of bariatric surgery (APPLES study: background, design and rationale

    Directory of Open Access Journals (Sweden)

    McCargar Linda

    2010-10-01

    Full Text Available Abstract Background Extreme obesity affects nearly 8% of Canadians, and is debilitating, costly and ultimately lethal. Bariatric surgery is currently the most effective treatment available; is associated with reductions in morbidity/mortality, improvements in quality of life; and appears cost-effective. However, current demand for surgery in Canada outstrips capacity by at least 1000-fold, causing exponential increases in already protracted, multi-year wait-times. The objectives and hypotheses of this study were as follows: 1. To serially assess the clinical, economic and humanistic outcomes in patients wait-listed for bariatric care over a 2-year period. We hypothesize deterioration in these outcomes over time; 2. To determine the clinical effectiveness and changes in quality of life associated with modern bariatric procedures compared with medically treated and wait-listed controls over 2 years. We hypothesize that surgery will markedly reduce weight, decrease the need for unplanned medical care, and increase quality of life; 3. To conduct a 3-year (1 year retrospective and 2 year prospective economic assessment of bariatric surgery compared to medical and wait-listed controls from the societal, public payor, and health-care payor perspectives. We hypothesize that lower indirect, out of pocket and productivity costs will offset increased direct health-care costs resulting in lower total costs for bariatric surgery. Methods/design Population-based prospective cohort study of 500 consecutive, consenting adults, including 150 surgically treated patients, 200 medically treated patients and 150 wait-listed patients. Subjects will be enrolled from the Edmonton Weight Wise Regional Obesity Program (Edmonton, Alberta, Canada, with prospective bi-annual follow-up for 2 years. Mixed methods data collection, linking primary data to provincial administrative databases will be employed. Major outcomes include generic, obesity-specific and preference

  20. The REFER (REFer for EchocaRdiogram protocol: a prospective validation of a clinical decision rule, NT-proBNP, or their combination, in the diagnosis of heart failure in primary care. Rationale and design

    Directory of Open Access Journals (Sweden)

    Tait Lynda

    2012-10-01

    Full Text Available Abstract Background Heart failure is a major cause of mortality and morbidity. As mortality rates are high, it is important that patients seen by general practitioners with symptoms suggestive of heart failure are identified quickly and treated appropriately. Identifying patients with heart failure or deciding which patients need further tests is a challenge. All patients with suspected heart failure should be diagnosed using objective tests such as echocardiography, but it is expensive, often delayed, and limited by the significant skill shortage of trained echocardiographers. Alternative approaches for diagnosing heart failure are currently limited. Clinical decision tools that combine clinical signs, symptoms or patient characteristics are designed to be used to support clinical decision-making and validated according to strict methodological procedures. The REFER Study aims to determine the accuracy and cost-effectiveness of our previously derived novel, simple clinical decision rule, a natriuretic peptide assay, or their combination, in the triage for referral for echocardiography of symptomatic adult patients who present in general practice with symptoms suggestive of heart failure. Methods/design This is a prospective, Phase II observational, diagnostic validation study of a clinical decision rule, natriuretic peptides or their combination, for diagnosing heart failure in primary care. Consecutive adult primary care patients 55 years of age or over presenting to their general practitioner with a chief complaint of recent new onset shortness of breath, lethargy or peripheral ankle oedema of over 48 hours duration, with no obvious recurrent, acute or self-limiting cause will be enrolled. Our reference standard is based upon a three step expert specialist consensus using echocardiography and clinical variables and tests. Discussion Our clinical decision rule offers a potential solution to the diagnostic challenge of providing a timely and

  1. Rationale and methods of the Prospective Study of Biomarkers, Symptom Improvement, and Ventricular Remodeling During Sacubitril/Valsartan Therapy for Heart Failure (PROVE-HF).

    Science.gov (United States)

    Januzzi, James L; Butler, Javed; Fombu, Emmanuel; Maisel, Alan; McCague, Kevin; Piña, Ileana L; Prescott, Margaret F; Riebman, Jerome B; Solomon, Scott

    2018-05-01

    Sacubitril/valsartan is an angiotensin receptor-neprilysin inhibitor indicated for the treatment of patients with chronic heart failure (HF) with reduced ejection fraction; however, its mechanism of benefit remains unclear. Biomarkers that are linked to ventricular remodeling, myocardial injury, and fibrosis may provide mechanistic insight and important clinical guidance regarding sacubitril/valsartan use. This 52-week, multicenter, open-label, single-arm study is designed to (1) correlate biomarker changes with cardiac remodeling parameters, cardiovascular outcomes, and patient-reported outcome data and (2) determine short- and long-term changes in concentrations of biomarkers related to potential mechanisms of action and effects of sacubitril/valsartan therapy. Approximately 830 patients with HF with reduced ejection fraction will be initiated and titrated on sacubitril/valsartan according to United States prescribing information. Primary efficacy end points include the changes in N-terminal pro-B-type natriuretic peptide concentrations and cardiac remodeling from baseline to 1 year. Secondary end points include changes in concentrations of N-terminal pro-B-type natriuretic peptide and remodeling to 6 months, and changes in patient-reported outcomes using the Kansas City Cardiomyopathy Questionnaire-23 from baseline to 1 year. In addition, several other relevant biomarkers will be measured. Biomarker changes relative to the number of cardiovascular events in 12 months will also be assessed as exploratory end points. Results from the Prospective Study of Biomarkers, Symptom Improvement, and Ventricular Remodeling During Sacubitril/Valsartan Therapy for Heart Failure (PROVE-HF) will help establish a mechanistic understanding of angiotensin receptor-neprilysin inhibitor therapeutic benefits and provide clinicians with clarity on how to interpret information on biomarkers during treatment (PROVE-HF ClinicalTrials.gov identifier: NCT02887183). Copyright © 2018 The

  2. Psychological and personality factors in type 2 diabetes mellitus, presenting the rationale and exploratory results from The Maastricht Study, a population-based cohort study

    DEFF Research Database (Denmark)

    van Dooren, Fleur E P; Denollet, Johan; Verhey, Frans R J

    2016-01-01

    BACKGROUND: Strong longitudinal evidence exists that psychological distress is associated with a high morbidity and mortality risk in type 2 diabetes. Little is known about the biological and behavioral mechanisms that may explain this association. Moreover, the role of personality traits...... in these associations is still unclear. In this paper, we first describe the design of the psychological part of The Maastricht Study that aims to elucidate these mechanisms. Next, we present exploratory results on the prevalence of depression, anxiety and personality traits in type 2 diabetes. Finally, we briefly....... Personality traits were measured by the DS14 and Big Five personality questionnaires. Type 2 diabetes was assessed by an oral glucose tolerance test. Logistic regression analyses were used to estimate the associations of depression, anxiety and personality with type 2 diabetes, adjusted for age, sex...

  3. Capturing microscopic features of bone remodeling into a macroscopic model based on biological rationales of bone adaptation.

    Science.gov (United States)

    Kim, Young Kwan; Kameo, Yoshitaka; Tanaka, Sakae; Adachi, Taiji

    2017-10-01

    To understand Wolff's law, bone adaptation by remodeling at the cellular and tissue levels has been discussed extensively through experimental and simulation studies. For the clinical application of a bone remodeling simulation, it is significant to establish a macroscopic model that incorporates clarified microscopic mechanisms. In this study, we proposed novel macroscopic models based on the microscopic mechanism of osteocytic mechanosensing, in which the flow of fluid in the lacuno-canalicular porosity generated by fluid pressure gradients plays an important role, and theoretically evaluated the proposed models, taking biological rationales of bone adaptation into account. The proposed models were categorized into two groups according to whether the remodeling equilibrium state was defined globally or locally, i.e., the global or local uniformity models. Each remodeling stimulus in the proposed models was quantitatively evaluated through image-based finite element analyses of a swine cancellous bone, according to two introduced criteria associated with the trabecular volume and orientation at remodeling equilibrium based on biological rationales. The evaluation suggested that nonuniformity of the mean stress gradient in the local uniformity model, one of the proposed stimuli, has high validity. Furthermore, the adaptive potential of each stimulus was discussed based on spatial distribution of a remodeling stimulus on the trabecular surface. The theoretical consideration of a remodeling stimulus based on biological rationales of bone adaptation would contribute to the establishment of a clinically applicable and reliable simulation model of bone remodeling.

  4. Chronic obstructive pulmonary disease, bronchial asthma and allergic rhinitis in the adult population within the commonwealth of independent states: rationale and design of the CORE study.

    Science.gov (United States)

    Feshchenko, Yuriy; Iashyna, Liudmyla; Nugmanova, Damilya; Gyrina, Olga; Polianska, Maryna; Markov, Alexander; Moibenko, Maryna; Makarova, Janina; Tariq, Luqman; Pereira, Marcelo Horacio S; Mammadbayov, Eljan; Akhundova, Irada; Vasylyev, Averyan

    2017-10-10

    Main treatable Chronic Respiratory Diseases (CRDs) like Chronic Obstructive Pulmonary Disease (COPD), Bronchial Asthma (BA) and Allergic Rhinitis (AR) are underdiagnosed and undertreated worldwide. CORE study was aimed to assess the point prevalence of COPD, BA and AR in the adult population of major cities of Commonwealth of Independent States (CIS) countries - Azerbaijan, Kazakhstan, and Ukraine based on study questionnaires and/or spirometry, and to document risk factors, characterize the COPD, BA and AR population to provide a clearer "epidemiological data". A descriptive, cross-sectional, population-based epidemiological study conducted from 2013 to 2015 with two-stage cluster geographical randomization. Interviewers conducted face-to-face visits at respondent's household after informed consent and eligibility assessment including interviews, anthropometry, spirometry (with bronchodilator test) and completion of disease-specific questionnaires. Two thousand eight hundred forty-two respondents (Ukraine: 964 from Ukraine; 945 from Kazakhstan; 933 Azerbaijan) were enrolled. Mean age was 40-42 years and males were 37%-42% across three countries. In Kazakhstan 62.8% were Asians, but in Ukraine and in Azerbaijan 99.7% and 100.0%, respectively, were Caucasians. Manual labourers constituted 40.5% in Ukraine, 22.8% in Kazakhstan and 22.0% in Azerbaijan, while office workers were 16.1%, 31.6% and 36.8% respectively. 51.3% respondents in Ukraine, 64.9% in Kazakhstan and 69.7% in Azerbaijan were married. CORE study collected information that can be supportive for health policy decision makers in allocating healthcare resources in order to improve diagnosis and management of CRDs. The detailed findings will be described in future publications. Study Protocol Summary is disclosed at GlaxoSmithKline Clinical Study Register on Jun 06, 2013, study ID 116757 .

  5. Summary reports for key Hoodia clinical studies

    CSIR Research Space (South Africa)

    Maharaj, VJ

    2011-12-01

    Full Text Available The CSIR has acquired the reports to 14 clinical studies in which Hoodia has been assesses, using crude extracts and concentrated active ingredients formulated in a number of different ways. In many of the studies Hoodia was found to be generally...

  6. Effectiveness of Oral Nutritional Supplementation for Older Women after a Fracture: Rationale, Design and Study of the Feasibility of a Randomized Controlled Study

    Directory of Open Access Journals (Sweden)

    Lockwood Keri A

    2011-06-01

    Full Text Available Abstract Background Malnutrition is a problem for many older people recovering from a hip and other major fractures. Oral supplementation with high calorie high protein nutrients is a simple intervention that may help older people with fractures to improve their recovery in terms of rehabilitation time, length of hospital stay and mortality. This paper reports a pilot study to test the feasibility of a trial initiated in a hospital setting with an oral supplement to older people with recent fractures. Method A randomized controlled trial with 44 undernourished participants admitted to a hospital following a fracture. The intervention group (n = 23 received a high calorie high protein supplement for forty days in addition to their diet of choice. The control group (n = 21 received high protein milk during their hospital stay in addition to their diet of choice and their usual diet when discharged from hospital. Results All participants were women and their mean age was 85.3 (± 6.1 years. Twenty nine (65% participants had a hip fracture. At baseline no differences were measured between the two groups regarding their nutritional status, their cognitive ability or their abilities in activities of daily living. There were no significant differences between the intervention and control group with reference to nutritional or functional parameters at 40 day and 4 month follow-ups. Median length of stay in hospital was 18.0 days, with 12 participants being readmitted for a median of 7.0 days. Conclusion It is feasible to perform a randomised trial in a hospital and community setting to test the effect of an oral high energy high protein supplement for older people. Due to the limited number of participants and incomplete adherence with use of the supplements no conclusion can be drawn about the efficacy or effectiveness of this intervention.

  7. Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Krüger Matthias

    2011-02-01

    Full Text Available Abstract Background Colorectal cancer is the second most common tumor in developed countries, with a lifetime prevalence of 5%. About one third of these tumors are located in the rectum. Surgery in terms of low anterior resection with mesorectal excision is the central element in the treatment of rectal cancer being the only option for definite cure. Creating a protective diverting stoma prevents complications like anastomotic failure and meanwhile is the standard procedure. Bowel obstruction is one of the main and the clinically and economically most relevant complication following closure of loop ileostomy. The best surgical technique for closure of loop ileostomy has not been defined yet. Methods/Design A study protocol was developed on the basis of the only randomized controlled mono-center trial to solve clinical equipoise concerning the optimal surgical technique for closure of loop ileostomy after low anterior resection due to rectal cancer. The HASTA trial is a multi-center pragmatic randomized controlled surgical trial with two parallel groups to compare hand-suture versus stapling for closure of loop ileostomy. It will include 334 randomized patients undergoing closure of loop ileostomy after low anterior resection with protective ileostomy due to rectal cancer in approximately 20 centers consisting of German hospitals of all level of health care. The primary endpoint is the rate of bowel obstruction within 30 days after ileostomy closure. In addition, a set of surgical and general variables including quality of life will be analyzed with a follow-up of 12 months. An investigators meeting with a practical session will help to minimize performance bias and enforce protocol adherence. Centers are monitored centrally as well as on-site before and during recruitment phase to assure inclusion, treatment and follow up according to the protocol. Discussion Aim of the HASTA trial is to evaluate the efficacy of hand-suture versus stapling for

  8. Rate of cardiac arrhythmias and silent brain lesions in experienced marathon runners: rationale, design and baseline data of the Berlin Beat of Running study

    Directory of Open Access Journals (Sweden)

    Haeusler Karl

    2012-08-01

    Full Text Available Abstract Background Regular exercise is beneficial for cardiovascular health but a recent meta-analysis indicated a relationship between extensive endurance sport and a higher risk of atrial fibrillation, an independent risk factor for stroke. However, data on the frequency of cardiac arrhythmias or (clinically silent brain lesions during and after marathon running are missing. Methods/ Design In the prospective observational “Berlin Beat of Running” study experienced endurance athletes underwent clinical examination (CE, 3 Tesla brain magnetic resonance imaging (MRI, carotid ultrasound imaging (CUI and serial blood sampling (BS within 2-3 days prior (CE, MRI, CUI, BS, directly after (CE, BS and within 2 days after (CE, MRI, BS the 38th BMW BERLIN-MARATHON 2011. All participants wore a portable electrocardiogram (ECG-recorder throughout the 4 to 5 days baseline study period. Participants with pathological MRI findings after the marathon, troponin elevations or detected cardiac arrhythmias will be asked to undergo cardiac MRI to rule out structural abnormalities. A follow-up is scheduled after one year. Results Here we report the baseline data of the enrolled 110 athletes aged 36-61 years. Their mean age was 48.8 ± 6.0 years, 24.5% were female, 8.2% had hypertension and 2.7% had hyperlipidaemia. Participants have attended a mean of 7.5 ± 6.6 marathon races within the last 5 years and a mean of 16 ± 36 marathon races in total. Their weekly running distance prior to the 38th BMW BERLIN-MARATHON was 65 ± 17 km. Finally, 108 (98.2% Berlin Beat-Study participants successfully completed the 38th BMW BERLIN-MARATHON 2011. Discussion Findings from the “Berlin Beats of Running” study will help to balance the benefits and risks of extensive endurance sport. ECG-recording during the marathon might contribute to identify athletes at risk for cardiovascular events. MRI results will give new insights into the link

  9. Marketing and clinical trials: a case study

    Directory of Open Access Journals (Sweden)

    Entwistle Vikki A

    2007-11-01

    Full Text Available Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  10. Marketing and clinical trials: a case study.

    Science.gov (United States)

    Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

    2007-11-20

    Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. The case study demonstrates that trials need various categories of people to buy in - hence, to be successful, trialists must embrace marketing strategies to some extent. The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  11. A clinical study of geriatric dermatoses

    OpenAIRE

    Leena Raveendra

    2014-01-01

    Introduction: The geriatric population is composed of persons over 65 years of age and very few studies are available on the dermatologic diseases in this group. This study was done to study the spectrum of cutaneous manifestations and prevalence of physiological and pathological changes in the skin of elderly people. Material and Methods: Two hundred consecutive patients aged more than 65 years of age attending the outpatient clinic or admitted as inpatients in the Department of Dermato...

  12. The Alabama VIP older driver study rationale and design: examining the relationship between vision impairment and driving using naturalistic driving techniques.

    Science.gov (United States)

    Owsley, Cynthia; McGwin, Gerald; Antin, Jonathan F; Wood, Joanne M; Elgin, Jennifer

    2018-02-07

    Older drivers aged ≥70 years old have among the highest rates of motor vehicle collisions (MVC) compared to other age groups. Driving is a highly visual task, and older adults have a high prevalence of vision impairment compared to other ages. Most studies addressing visual risk factors for MVCs by older drivers utilize vehicle accident reports as the primary outcome, an approach with several methodological limitations. Naturalistic driving research methods overcome these challenges and involve installing a high-tech, unobtrusive data acquisition system (DAS) in an older driver's own vehicle. The DAS continuously records multi-channel video of driver and roadway, sensor-based kinematics, GPS location, and presence of nearby objects in front of the vehicle, providing an objective measure of driving exposure. In this naturalistic driving study, the purpose is to examine the relationship between vision and crashes and near-crashes, lane-keeping, turning at intersections, driving performance during secondary tasks demands, and the role of front-seat passengers. An additional aim is to compare results of the on-road driving evaluation by a certified driving rehabilitation specialist to objective indicators of driving performance derived from the naturalistic data. Drivers ≥70 years old are recruited from ophthalmology clinics and a previous population-based study of older drivers, with the goal of recruiting persons with wide ranging visual function. Target samples size is 195 drivers. At a baseline visit, the DAS is installed in the participant's vehicle and a battery of health and functional assessments are administered to the driver including visual-sensory and visual-cognitive tests. The DAS remains installed in the vehicle for six months while the participant goes about his/her normal driving with no imposed study restrictions. After six months, the driver returns for DAS de-installation, repeat vision testing, and an on-road driving evaluation by a certified

  13. Psychological risk factors of micro- and macrovascular outcomes in primary care patients with type 2 diabetes: rationale and design of the DiaDDZoB Study

    Directory of Open Access Journals (Sweden)

    Pop Victor JM

    2010-07-01

    Full Text Available Abstract Background Depression is a common psychiatric complication of diabetes, but little is known about the natural course and the consequences of depressive symptoms in primary care patients with type 2 diabetes. While depression has been related to poor glycemic control and increased risk for macrovascular disease, its association with microvascular complications remains understudied. The predictive role of other psychological risk factors such as Type D (distressed personality and the mechanisms that possibly link depression and Type D personality with poor vascular outcomes are also still unclear. Methods/Design This prospective cohort study will examine: (1 the course of depressive symptoms in primary care patients with type 2 diabetes; (2 whether depressive symptoms and Type D personality are associated with the development of microvascular and/or macrovascular complications and with the risk of all-cause or vascular mortality; and (3 the behavioral and physiological mechanisms that may mediate these associations. The DiaDDZoB Study is embedded within the larger DIAZOB Primary Care Diabetes study, which covers a comprehensive cohort of type 2 diabetes patients treated by over 200 primary care physicians in South-East Brabant, The Netherlands. These patients will be followed during their lifetime and are assessed annually for demographic, clinical, lifestyle and psychosocial factors. Measurements include an interviewer-administered and self-report questionnaire, regular care laboratory tests and physical examinations, and pharmacy medication records. The DiaDDZoB Study uses data that have been collected during the original baseline assessment in 2005 (M0; N = 2,460 and the 2007 (M1; N = 2,225 and 2008 (M2; N = 2,032 follow-up assessments. Discussion The DiaDDZoB Study is expected to contribute to the current understanding of the course of depression in primary care patients with type 2 diabetes and will also test whether depressed

  14. Integrating a family-focused approach into child obesity prevention: Rationale and design for the My Parenting SOS study randomized control trial

    Directory of Open Access Journals (Sweden)

    Campbell Marci

    2011-06-01

    Full Text Available Abstract Background More than 20% of US children ages 2-5 yrs are classified as overweight or obese. Parents greatly influence the behaviors their children adopt, including those which impact weight (e.g., diet and physical activity. Unfortunately, parents often fail to recognize the risk for excess weight gain in young children, and may not be motivated to modify behavior. Research is needed to explore intervention strategies that engage families with young children and motivate parents to adopt behaviors that will foster healthy weight development. Methods This study tests the efficacy of the 35-week My Parenting SOS intervention. The intervention consists of 12 sessions: initial sessions focus on general parenting skills (stress management, effective parenting styles, child behavior management, coparenting, and time management and later sessions apply these skills to promote healthier eating and physical activity habits. The primary outcome is change in child percent body fat. Secondary measures assess parent and child dietary intake (three 24-hr recalls and physical activity (accelerometry, general parenting style and practices, nutrition- and activity-related parenting practices, and parent motivation to adopt healthier practices. Discussion Testing of these new approaches contributes to our understanding of how general and weight-specific parenting practices influence child weight, and whether or not they can be changed to promote healthy weight trajectories. Trial Registration ClinicalTrials.gov: NCT00998348

  15. Childhood obesity prevention in rural settings: background, rationale, and study design of ‘4-Health,’ a parent-only intervention

    Directory of Open Access Journals (Sweden)

    Lynch Wesley C

    2012-04-01

    Full Text Available Abstract Background Childhood obesity in rural communities is a serious but understudied problem. The current experiment aims to assess a wide range of obesity risk factors among rural youth and to offer an 8-month intervention program for parents to reduce obesity risk in their preteen child. Methods/Design A two-group, repeated measures design is used to assess the effectiveness of the 4-Health intervention program. Assessments include anthropometric measures, child self-evaluations, parent self-evaluations, and parent evaluations of child. County Extension agents from 21 rural Montana counties recruit approximately 150 parent–child dyads and counties are semi-randomly assigned to the active intervention group (4-Health Educational Program or a “best-practices” (Healthy Living Information control group. Discussion This study will shed light on the effectiveness of this parent-only intervention strategy in reducing obesity risk factors among rural preteens. The 4-Health program is designed to provide information and skills development for busy rural parents that will increase healthy lifestyles of their preteen children and improve the parents’ ability to intervene effectively in the lives of their families during this critical developmental period. Trial registration ClinicalTrials.gov ID: NCT01510587

  16. Integrating a family-focused approach into child obesity prevention: rationale and design for the My Parenting SOS study randomized control trial.

    Science.gov (United States)

    Ward, Dianne S; Vaughn, Amber E; Bangdiwala, Kant I; Campbell, Marci; Jones, Deborah J; Panter, Abigail T; Stevens, June

    2011-06-05

    More than 20% of US children ages 2-5 yrs are classified as overweight or obese. Parents greatly influence the behaviors their children adopt, including those which impact weight (e.g., diet and physical activity). Unfortunately, parents often fail to recognize the risk for excess weight gain in young children, and may not be motivated to modify behavior. Research is needed to explore intervention strategies that engage families with young children and motivate parents to adopt behaviors that will foster healthy weight development. This study tests the efficacy of the 35-week My Parenting SOS intervention. The intervention consists of 12 sessions: initial sessions focus on general parenting skills (stress management, effective parenting styles, child behavior management, coparenting, and time management) and later sessions apply these skills to promote healthier eating and physical activity habits. The primary outcome is change in child percent body fat. Secondary measures assess parent and child dietary intake (three 24-hr recalls) and physical activity (accelerometry), general parenting style and practices, nutrition- and activity-related parenting practices, and parent motivation to adopt healthier practices. Testing of these new approaches contributes to our understanding of how general and weight-specific parenting practices influence child weight, and whether or not they can be changed to promote healthy weight trajectories. ClinicalTrials.gov: NCT00998348.

  17. Distance learning strategies for weight management utilizing social media: A comparison of phone conference call versus social media platform. Rationale and design for a randomized study.

    Science.gov (United States)

    Willis, Erik A; Szabo-Reed, Amanda N; Ptomey, Lauren T; Steger, Felicia L; Honas, Jeffery J; Al-Hihi, Eyad M; Lee, Robert; Vansaghi, Lisa; Washburn, Richard A; Donnelly, Joseph E

    2016-03-01

    Management of obesity in the context of the primary care physician visit is of limited efficacy in part because of limited ability to engage participants in sustained behavior change between physician visits. Therefore, healthcare systems must find methods to address obesity that reach beyond the walls of clinics and hospitals and address the issues of lifestyle modification in a cost-conscious way. The dramatic increase in technology and online social networks may present healthcare providers with innovative ways to deliver weight management programs that could have an impact on health care at the population level. A randomized study will be conducted on 70 obese adults (BMI 30.0-45.0 kg/m(2)) to determine if weight loss (6 months) is equivalent between weight management interventions utilizing behavioral strategies by either a conference call or social media approach. The primary outcome, body weight, will be assessed at baseline and 6 months. Secondary outcomes including waist circumference, energy and macronutrient intake, and physical activity will be assessed on the same schedule. In addition, a cost analysis and process evaluation will be completed. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. "GET-UP" study rationale and protocol: a cluster randomised controlled trial to evaluate the effects of reduced sitting on toddlers' cognitive development.

    Science.gov (United States)

    Santos, Rute; Cliff, Dylan P; Howard, Steven J; Veldman, Sanne L; Wright, Ian M; Sousa-Sá, Eduarda; Pereira, João R; Okely, Anthony D

    2016-11-09

    The educational and cognitive differences associated with low socioeconomic status begin early in life and tend to persist throughout life. Coupled with the finding that levels of sedentary time are negatively associated with cognitive development, and time spent active tends to be lower in disadvantaged circumstances, this highlights the need for interventions that reduce the amount of time children spend sitting and sedentary during childcare. The proposed study aims to assess the effects of reducing sitting time during Early Childhood Education and Care (ECEC) services on cognitive development in toddlers from low socio-economic families. We will implement a 12-months 2-arm parallel group cluster randomised controlled trial (RCT) with Australian toddlers, aged 12 to 26 months at baseline. Educators from the ECEC services allocated to the intervention group will receive professional development on how to reduce sitting time while children attend ECEC. Participants' cognitive development will be assessed as a primary outcome, at baseline and post-intervention, using the cognitive sub-test from the Bayley Scales of Infant and Toddler Development. This trial has the potential to inform programs and policies designed to optimize developmental and health outcomes in toddlers, specifically in those from disadvantaged backgrounds. Australian New Zealand Clinical Trials Registry: ACTRN12616000471482 , 11/04/2016, retrospectively registered.

  19. The lung cancer exercise training study: a randomized trial of aerobic training, resistance training, or both in postsurgical lung cancer patients: rationale and design

    Directory of Open Access Journals (Sweden)

    Crawford Jeffrey

    2010-04-01

    in gene expression. Discussion VO2peak is becoming increasingly recognized as an outcome of major importance in NSCLC. LUNGEVITY will identify the optimal form of exercise training for NSCLC survivors as well as provide insight into the physiological mechanisms underlying this effect. Overall, this study will contribute to the establishment of clinical exercise therapy rehabilitation guidelines for patients across the entire NSCLC continuum. Trial Registration NCT00018255

  20. Using design rationale to improve SPL traceability

    NARCIS (Netherlands)

    Galvao, I.; Aksit, Mehmet; van den Broek, P.M.; Hendriks, M.F.H.; Rashid, Awais; Royer, Jean-Claude; Rummler, Andreas

    In order to improve SPL traceability by using design rationale, this chapter introduces the traceability analysis framework (TAF), which, when combined with the AMPLE Traceability Framework, provides extra traceability capabilities for variability management. The TAF is a programmable and extensible

  1. Bioethics: A Rationale and a Model

    Science.gov (United States)

    Barman, Charles R.; Rusch, John J.

    1978-01-01

    Discusses the rationale for and development of an undergraduate bioethics course. Based on experiences with the course, general suggestions are offered to instructors planning to add bioethics to existing curricula. (MA)

  2. Left ventricular noncompaction: Clinical-echocardiographic study

    Directory of Open Access Journals (Sweden)

    Nikolić Aleksandra

    2012-01-01

    Full Text Available Background/Aim. Left ventricular noncompaction (LVNC is a disorder in endomyocardial morphogenesis, seen either isolated (in the absence of other cardiac anomalies or in association with congenital heart disease and some neuromuscular diseases. Intrauterine arrest of the compaction of myocardial fibers is postulated to be the reason of LVNC. Recognition of this condition is extremely important due to its high mortality and morbidity that lead to progressive heart failure, ventricular arrhythmias and thromboembolic events. The aim of this study was to determine the prevalence and clinical presentation of LVNC among consecutive outpatients according to clinical and echocardiographyic findings. Methode. A total of 3,854 consecutive patients examined at the Institute for Cardiovascular Diseases within a period January 2006 - January 2007 were included in the study. All the patients underwent echocardiographic examination using the same equipment (Vivid 7, GE Medical System. Echocardiographic parameters and clinical presentation in patients with echocardiographic criteria for LVNC were analyzed. Results. Analyzing 3,854 consecutive outpatients, using two-dimensional Color Doppler echocardiography from January 2006 to January 2007, 12 patients met the criteria for LVNC. Seven of them were male. The mean age at diagnosis was 45 ± 15 years. Analyzing clinical manifestation of LVNC it was found that seven patients had signs of heart failure, six had arrhythmias with no embolic events. Conclusion. Our results suggest that the real prevalence of LVNC may be higher than expected. New studies have to be done to solve this problem.

  3. New Rationales for Women on Boards

    OpenAIRE

    Choudhury, B.

    2014-01-01

    Should measures promoting women to corporate boards be solely justified in terms of economic arguments? Traditionally, such measures have tended to rely on utilitarian arguments, despite the fact that the most prominent of these arguments—the relationship between women’s presence on boards and firm financial performance—is equivocal. Conversely, this article argues that rationales for increasing women on boards should be based on both equality and economics grounds. An equality rationale is n...

  4. Home administration of maintenance pemetrexed for patients with advanced non-squamous non-small cell lung cancer: rationale, practicalities and phase II feasibility study design.

    Science.gov (United States)

    Lal, Rohit; Bourayou, Nawel; Hillerdal, Gunnar; Nicolson, Marianne; Vikstrom, Anders; Lorenzo, Maria; D'yachkova, Yulia; Barriga, Susana; Visseren-Grul, Carla

    2013-10-03

    requires unusual methodology and specific logistics to address outcomes relevant to the home-delivery approach. This article presents a study design that offers a novel and reproducible model for home-based chemotherapy, and provides an up-to-date overview of the literature regarding this type of treatment. ClinicalTrials.gov: NCT01473563.

  5. Theoretical rationale for music selection in oncology intervention research: an integrative review.

    Science.gov (United States)

    Burns, Debra S

    2012-01-01

    Music-based interventions have helped patients with cancer improve their quality of life, decrease treatment related distress, and manage pain. However, quantitative findings from music intervention studies are inconsistent. The purpose of this review was to explore the theoretical underpinnings for the selection of the music stimuli used to influence targeted outcomes. It was hypothesized that disparate findings were due in part to the atheoretical nature of music selection and the resulting diversity in music stimuli between and within studies. A systematic research synthesis including a comprehensive database and reference list search resulted in 22 studies. Included studies were compiled into two tables cataloging intervention theory, intervention content, and outcomes. A majority of studies did not provide a rationale or intervention theory for the delivery of music or choice of outcomes. Recorded music was the most common delivery method, but the specific music was rarely included within the report. Only two studies that included a theoretical framework reported null results on at least some of the outcomes. Null results are partially explained by an incomplete or mismatch in intervention theory and music selection and delivery. While the inclusion of an intervention theory does not guarantee positive results, including a theoretical rationale for the use of music, particular therapeutic processes or mechanisms, and the specifics of how music is selected and delivered increases scientific rigor and the probability of clinical translation.

  6. Rationale and study design of a patient-centered intervention to improve health status in chronic heart failure: The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) randomized trial.

    Science.gov (United States)

    Bekelman, David B; Allen, Larry A; Peterson, Jamie; Hattler, Brack; Havranek, Edward P; Fairclough, Diane L; McBryde, Connor F; Meek, Paula M

    2016-11-01

    While contemporary heart failure management has led to some improvements in morbidity and mortality, patients continue to report poor health status (i.e., burdensome symptoms, impaired function, and poor quality of life). The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) trial is a NIH-funded, three-site, randomized clinical trial that examines the effect of the CASA intervention compared to usual care on the primary outcome of patient-reported health status at 6months in patients with heart failure and poor health status. The CASA intervention involves a nurse who works with patients to treat symptoms (e.g., shortness of breath, fatigue, pain) using disease-specific and palliative approaches, and a social worker who provides psychosocial care targeting depression and adjustment to illness. The intervention uses a collaborative care team model of health care delivery and is structured and primarily phone-based to enhance reproducibility and scalability. This article describes the rationale and design of the CASA trial, including several decision points: (1) how to design a patient-centered intervention to improve health status; (2) how to structure the intervention so that it is reproducible and scalable; and (3) how to systematically identify outpatients with heart failure most likely to need and benefit from the intervention. The results should provide valuable information to providers and health systems about the use of team care to manage symptoms and provide psychosocial care in chronic illness. Published by Elsevier Inc.

  7. A randomized controlled trial of tai chi for long-term low back pain (TAI CHI: Study rationale, design, and methods

    Directory of Open Access Journals (Sweden)

    Hall Amanda M

    2009-05-01

    Full Text Available Abstract Background Low back pain persisting for longer than 3 months is a common and costly condition for which many current treatments have low-moderate success rates at best. Exercise is among the more successful treatments for this condition, however, the type and dosage of exercise that elicits the best results is not clearly defined. Tai chi is a gentle form of low intensity exercise that uses controlled movements in combination with relaxation techniques and is currently used as a safe form of exercise for people suffering from other chronic pain conditions such as arthritis. To date, there has been no scientific evaluation of tai chi as an intervention for people with back pain. Thus the aim of this study will be to examine the effects of a tai chi exercise program on pain and disability in people with long-term low back pain. Methods and design The study will recruit 160 healthy individuals from the community setting to be randomised to either a tai chi intervention group or a wait-list control group. Individuals in the tai chi group will attend 2 tai chi sessions (40 minutes/week for 8 weeks followed by 1 tai chi session/week for 2 weeks. The wait-list control will continue their usual health care practices and have the opportunity to participate in the tai chi program once they have completed the follow-up assessments. The primary outcome will be bothersomeness of back symptoms measured with a 0–10 numerical rating scale. Secondary outcomes include, self-reports of pain-related disability, health-related quality of life and global perceived effect of treatment. Statistical analysis of primary and secondary outcomes will be based on the intention to treat principle. Linear mixed models will be used to test for the effect of treatment on outcome at 10 weeks follow up. This trial has received ethics approval from The University of Sydney Human Research Ethics Committee. HREC Approval No.10452 Discussion This study will be the first

  8. A systems biology approach to studying Tai Chi, physiological complexity and healthy aging: design and rationale of a pragmatic randomized controlled trial.

    Science.gov (United States)

    Wayne, Peter M; Manor, Brad; Novak, Vera; Costa, Madelena D; Hausdorff, Jeffrey M; Goldberger, Ary L; Ahn, Andrew C; Yeh, Gloria Y; Peng, C-K; Lough, Matthew; Davis, Roger B; Quilty, Mary T; Lipsitz, Lewis A

    2013-01-01

    Aging is typically associated with progressive multi-system impairment that leads to decreased physical and cognitive function and reduced adaptability to stress. Due to its capacity to characterize complex dynamics within and between physiological systems, the emerging field of complex systems biology and its array of quantitative tools show great promise for improving our understanding of aging, monitoring senescence, and providing biomarkers for evaluating novel interventions, including promising mind-body exercises, that treat age-related disease and promote healthy aging. An ongoing, two-arm randomized clinical trial is evaluating the potential of Tai Chi mind-body exercise to attenuate age-related loss of complexity. A total of 60 Tai Chi-naïve healthy older adults (aged 50-79) are being randomized to either six months of Tai Chi training (n=30), or to a waitlist control receiving unaltered usual medical care (n=30). Our primary outcomes are complexity-based measures of heart rate, standing postural sway and gait stride interval dynamics assessed at 3 and 6months. Multiscale entropy and detrended fluctuation analysis are used as entropy- and fractal-based measures of complexity, respectively. Secondary outcomes include measures of physical and psychological function and tests of physiological adaptability also assessed at 3 and 6months. Results of this study may lead to novel biomarkers that help us monitor and understand the physiological processes of aging and explore the potential benefits of Tai Chi and related mind-body exercises for healthy aging. Copyright © 2012 Elsevier Inc. All rights reserved.

  9. Rationale and design of the Study of a Tele-pharmacy Intervention for Chronic diseases to Improve Treatment adherence (STIC2IT): A cluster randomized pragmatic trial

    Science.gov (United States)

    Choudhry, Niteesh K.; Isaac, Thomas; Lauffenburger, Julie C.; Gopalakrishnan, Chandrasekar; Khan, Nazleen F.; Lee, Marianne; Vachon, Amy; Iliadis, Tanya L.; Hollands, Whitney; Doheny, Scott; Elman, Sandra; Kraft, Jacqueline M.; Naseem, Samrah; Gagne, Joshua J.; Jackevicius, Cynthia A.; Fischer, Michael A.; Solomon, Daniel H.; Sequist, Thomas D.

    2016-01-01

    Background Approximately half of patients with chronic cardiometabolic conditions are non-adherent with their prescribed medications. Interventions to improve adherence have been only modestly effective because they often address single barriers to adherence, intervene at single points in time, or are imprecisely targeted to patients who may or may not need adherence assistance. Objective To evaluate the effect of a multi-component, behaviorally-tailored pharmacist-based intervention to improve adherence to medications for diabetes, hypertension, and hyperlipidemia. Trial design The STIC2IT (Study of a Tele-pharmacy Intervention for Chronic diseases To Improve Treatment adherence) trial is a cluster-randomized pragmatic trial testing the impact of a pharmacist-led multi-component intervention that uses behavioral interviewing, text messaging, mailed progress reports and video visits. Targeted patients are those who are non-adherent to glucose-lowering, anti-hypertensive, or statin medications and who also have evidence of poor disease control. The intervention is tailored to patients’ individual health barriers and their level of health activation. We cluster randomized 14 practice sites of a large multi-specialty group practice to receive either the pharmacist-based intervention or usual care. STIC2IT has enrolled 4,076 patients to be followed for 12 months after randomization. The trial’s primary outcome is medication adherence, assessed using pharmacy claims data. Secondary outcomes are disease control and healthcare resource utilization. Conclusion This trial will determine whether a technologically-enabled, behaviorally-targeted pharmacist-based intervention results in improved adherence and disease control. If effective, this strategy could be a scalable method of offering tailored adherence support to those with the greatest clinical need. PMID:27659887

  10. Design and rationale of the MR-INFORM study: stress perfusion cardiovascular magnetic resonance imaging to guide the management of patients with stable coronary artery disease

    Directory of Open Access Journals (Sweden)

    Hussain Shazia T

    2012-09-01

    Full Text Available Abstract Background In patients with stable coronary artery disease (CAD, decisions regarding revascularisation are primarily driven by the severity and extent of coronary luminal stenoses as determined by invasive coronary angiography. More recently, revascularisation decisions based on invasive fractional flow reserve (FFR have shown improved event free survival. Cardiovascular magnetic resonance (CMR perfusion imaging has been shown to be non-inferior to nuclear perfusion imaging in a multi-centre setting and superior in a single centre trial. In addition, it is similar to invasively determined FFR and therefore has the potential to become the non-invasive test of choice to determine need for revascularisation. Trial design The MR-INFORM study is a prospective, multi-centre, randomised controlled non-inferiority, outcome trial. The objective is to compare the efficacy of two investigative strategies for the management of patients with suspected CAD. Patients presenting with stable angina are randomised into two groups: 1 The FFR-INFORMED group has subsequent management decisions guided by coronary angiography and fractional flow reserve measurements. 2 The MR-INFORMED group has decisions guided by stress perfusion CMR. The primary end-point will be the occurrence of major adverse cardiac events (death, myocardial infarction and repeat revascularisation at one year. Clinical trials.gov identifier NCT01236807. Conclusion MR INFORM will assess whether an initial strategy of CMR perfusion is non-inferior to invasive angiography supplemented by FFR measurements to guide the management of patients with stable coronary artery disease. Non-inferiority of CMR perfusion imaging to the current invasive reference standard (FFR would establish CMR perfusion imaging as an attractive non-invasive alternative to current diagnostic pathways.

  11. Clinical Pharmacology Studies in Critically Ill Children

    Science.gov (United States)

    Thakkar, Nilay; Salerno, Sara; Hornik, Christoph P.; Gonzalez, Daniel

    2016-01-01

    Developmental and physiological changes in children contribute to variation in drug disposition with age. Additionally, critically ill children suffer from various life-threatening conditions that can lead to pathophysiological alterations that further affect pharmacokinetics (PK). Some factors that can alter PK in this patient population include variability in tissue distribution caused by protein binding changes and fluid shifts, altered drug elimination due to organ dysfunction, and use of medical interventions that can affect drug disposition (e.g., extracorporeal membrane oxygenation and continuous renal replacement therapy). Performing clinical studies in critically ill children is challenging because there is large inter-subject variability in the severity and time course of organ dysfunction; some critical illnesses are rare, which can affect subject enrollment; and critically ill children usually have multiple organ failure, necessitating careful selection of a study design. As a result, drug dosing in critically ill children is often based on extrapolations from adults or non-critically ill children. Dedicated clinical studies in critically ill children are urgently needed to identify optimal dosing of drugs in this population. This review will summarize the effect of critical illness on pediatric PK, the challenges associated with performing studies in this vulnerable subpopulation, and the clinical PK studies performed to date for commonly used drugs. PMID:27585904

  12. [Clinical studies on flomoxef in neonates].

    Science.gov (United States)

    Tabuki, K; Nishimura, T

    1993-07-01

    Clinical studies on flomoxef (FMOX) were performed in neonates and the results obtained are summarized as follows. Treatment with FMOX was made in 4 cases of neonatal bacterial infections; 2 cases of sepsis (suspected) and 1 case each of infection of umbilicus and staphylococcal scalded skin syndrome. Results obtained were excellent in 1 case, good in 3 cases. No significant side effects due to the drug were observed in any cases.

  13. Nail disorders in children, a clinical study

    Directory of Open Access Journals (Sweden)

    Ayşe Akbaş

    2016-04-01

    Full Text Available Introduction: Aims of the study to investigate the frequency and the nature ofnail disorders in children significant clinical data is available. Nail disorders although common in children in some parts of our country. This study was carried out to document the clinical and demographic pattern of nail disorders in a dermatology outpatient clinic of a pediatric hospital in Ankara, Turkey. Material and Methods: All consecutive patients a total of 3000 children from age 0-16 were admitted to dermatology outpatient clinic of Ankara Pediatric Hematology and Oncology Education and Research Hospital during January 2011 to December 2011 were studied and retrospectively evaluated for age, gender, drug use, diseases, systemic or genetic disorders and demographic features. Diagnostic evaluation results were noted and patients were categorized for demographic features and diagnosis. Results: These 133 patients (M: F 58:75, %44 vs 56, respectively were under 16 years of age and have 17 different dermatological disorders related with nail symptoms. Fifty three of (39,8% these patient were under 2 years of age, 31 (23.3% were between 3-5 years, 30 (22.5% were between 6-11 years old, 19 of 133 (14%, 2 were between 11-16 years of age. Through all of ages and independent of gender the most etiologies of nail disorders were, onychomadesis, paronychia, onycholysis, onychomycosis and systemic nail presentation of systemic dermatosis. Conclusion: Nail disorders are different in children than in adults. In our study, the first 5 years of age was found in 53% of nail disorders. Nail disorders are uncommon but may be seen as a part of a systemic disease and may be associated with cosmetic and psychologic problem.

  14. Marketing and clinical trials: a case study

    OpenAIRE

    Entwistle Vikki A; Snowdon Claire; Garcia Jo; Knight Rosemary C; Shakur Haleema; Elbourne Diana R; Roberts Ian; Francis David; McDonald Alison M; Grant Adrian M; Campbell Marion K

    2007-01-01

    Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, o...

  15. Referral from primary care to a physical activity programme: establishing long-term adherence? A randomized controlled trial. Rationale and study design

    Directory of Open Access Journals (Sweden)

    Puig-Ribera Anna

    2009-01-01

    . Discussion The pilot study showed the effectiveness of an enhanced low-cost, evidence-based intervention in increased physical activity and improved social support. If successful in demonstrating long-term improvements, this randomised controlled trial will be the first sustainable physical activity intervention based in primary care in our country to demonstrate long-term adherence to physical activity. Trial Registration A service of the U.S. National Institutes of Health. Developed by the National Library of Medicine. ClinicalTrials.gov ID: NCT00714831.

  16. 'Physical activity at home (PAAH)', evaluation of a group versus home based physical activity program in community dwelling middle aged adults: rationale and study design.

    Science.gov (United States)

    Freene, Nicole; Waddington, Gordon; Chesworth, Wendy; Davey, Rachel; Goss, John

    2011-11-24

    It is well recognised that the adoption and longer term adherence to physical activity by adults to reduce the risk of chronic disease is a challenge. Interventions, such as group and home based physical activity programs, have been widely reported upon. However few studies have directly compared these interventions over the longer term to determine their adherence and effectiveness. Participant preference for home based or group interventions is important. Some evidence suggests that home based physical activity programs are preferred by middle aged adults and provide better long term physical activity adherence. Physiotherapists may also be useful in increasing physical activity adherence, with limited research on their impact. 'Physical Activity at Home' is a 2 year pragmatic randomised control trial, with a non-randomised comparison to group exercise. Middle-aged adults not interested in, or unable to attend, a group exercise program will be targeted. Sedentary community dwelling 50-65 year olds with no serious medical conditions or functional impairments will be recruited via two mail outs using the Australian federal electoral roll. The first mail out will invite participants to a 6 month community group exercise program. The second mail out will be sent to those not interested in the group exercise program inviting them to take part in a home based intervention. Eligible home based participants will be randomised into a 6 month physiotherapy-led home based physical activity program or usual care. Outcome measures will be taken at baseline, 6, 12, 18 and 24 months. The primary outcome is physical activity adherence via exercise diaries. Secondary outcomes include the Active Australia Survey, accelerometry, aerobic capacity (step test), quality of life (SF-12v2), blood pressure, waist circumference, waist-to-hip ratio and body mass index. Costs will be recorded prospectively and qualitative data will be collected. The planned 18 month follow-up post

  17. Clinical and experimental studies on radiation proctitis

    International Nuclear Information System (INIS)

    Honke, Yoshifumi

    1988-01-01

    Clinical and experimental studies were performed to clarify the mechanism of developing radiation proctitis. The results were as follows; (1) In the clinical study with 38 uterine cervix cancer patients, who received radiotherapy, diarrhea was observed in 44.7% at the acute stage, while rectal bleeding in 36.7% about 1 year after radiation. However, no clinical correlation was observed between diarrhea and rectal bleeding. (2) Colon fiberscopic examination revealed little change at the acute stage. However, erosion, ulcer and remarkable redness were found at the late stage. By the magnified fiberscope, unit degeneration was found in 72.8% at the acute stage. (3) Concerning the histopathological changes, edema and inflammatory change were observed immediately after irradiation. Fibrosis was observed in 83.3% at the late stage. (4) The number of the immunoglobulin containing cells decreased by radiation. However, its recovered as time passed after radiation. (5) In experimental study with rats by microangiography, there were ramarkable changes of the small vessels, such as bending, tortuosity and capillary hyperplasia at the acute stage. However, these changes returned to normal soon. At the late stage, decreased number of blood vessels were observed. The above results indicated that rectal bleeding after exposure to radiation are developed by secondary circulation abnormality caused by fibrosis of the perivascular tissues. (author) 52 refs

  18. The clinic-statistic study of osteoporosis

    Directory of Open Access Journals (Sweden)

    Florin MARCU

    2008-05-01

    Full Text Available Osteoporosis is the most common metabolic bone disease and is characterized by the shrinkage in bone mass and the distruction of bone quality, thus conferring a higher risk for fractures and injuries. Osteoporosis reaches clinical attention when it is severe enough to induce microfractures and the collapsing of vertebral bodies manifesting with back aches or predisposition to other bone fractures. The aim of the study was to establish a statistic-numeric report between women and men in subjects diagnosed with osteoporosis through DEXA that present with a clinical simptomatology. We studied a group of subjects of masculine and feminine genders that have been diagnosed with osteoporosis through DEXA at the EURORAD clinic in Oradea from 01.01.2007-to present time .The result of the study was that the simptomatology of osteoporosis with pain and even cases of fractures is more obvious in female subjects then in male patients; statistically ,a woman/man report of 6.1/1 was established.

  19. Clinical and Statistical Study on Canine Impaction

    Directory of Open Access Journals (Sweden)

    Adina-Simona Coșarcă

    2013-08-01

    Full Text Available Aim: The aim of this study was to perform a clinical and statistical research on permanent impacted canine patients among those with dental impaction referred to and treated at the Oral and Maxillo-Facial Surgery Clinic of Tîrgu Mureș, over a four years period (2009-2012. Materials and methods: The study included 858 patients having dental impaction, and upon clinical records, different parameters, like frequency, gender, age, quadrant involvement, patient residence, associated complications, referring specialist and type of treatment, related to canine impaction, were assessed. Results: The study revealed: about 10% frequency of canine impaction among dental impactions; more frequent in women, in the first quadrant (tooth 13; most cases diagnosed between the age of 10-19 years; patients under 20 were referred by an orthodontist, those over 20 by a dentist; surgical exposure was more often performed than odontectomy. Conclusions: Canine impaction is the second-most frequent dental impaction in dental arch after third molars; it occurs especially in women. Due to its important role, canine recovery within dental arch is a goal to be achieved, whenever possible. Therefore, diagnose and treatment of canine impaction requires an interdisciplinary approach (surgical and orthodontic

  20. Randomised clinical trial of cryoballoon versus irrigated radio frequency catheter ablation for atrial fibrillation-the effect of double short versus standard exposure cryoablation duration during pulmonary vein isolation (CIRCA-DOSE): methods and rationale.

    Science.gov (United States)

    Andrade, Jason G; Deyell, Marc W; Badra, Mariano; Champagne, Jean; Dubuc, Marc; Leong-Sit, Peter; Macle, Laurent; Novak, Paul; Roux, Jean-Francois; Sapp, John; Tang, Anthony; Verma, Atul; Wells, George A; Khairy, Paul

    2017-10-05

    Pulmonary vein isolation (PVI) is an effective therapy for paroxysmal atrial fibrillation (AF), but it has limitations. The two most significant recent advances have centred on the integration of real-time quantitative assessment of catheter contact force into focal radio frequency (RF) ablation catheters and the development of dedicated ablation tools capable of achieving PVI with a single ablation lesion (Arctic Front cryoballoon, Medtronic, Minneapolis, MN, USA). Although each of these holds promise for improving the clinical success of catheter ablation of AF, there has not been a rigorous comparison of these advanced ablation technologies. Moreover, the optimal duration of cryoablation (freezing time) has not been determined. Patients undergoing an initial PVI procedure for paroxysmal AF will be recruited. Patients will be randomised 1:1:1 between contact-force irrigated RF ablation, short duration cryoballoon ablation (2 min applications) and standard duration cryoballoon ablation (4 min applications). The primary outcome is time to first documented AF recurrence on implantable loop recorder. With a sample size of 111 per group and a two-sided 0.025 significance level (to account for the two main comparisons), the study will have 80% power (using a log-rank test) to detect a difference of 20% between contact force RF catheter ablation and either of the two cryoballoon ablation groups. Factoring in a 4% loss to follow-up, 116 patients per group should be randomised and followed for a year (total study population of 348). The study was approved by the University of British Columbia Office of Research (Services) Ethics Clinical Research Ethics Board. Results of the study will be submitted for publication in a peer-reviewed journal. NCT01913522; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  1. Angular cheilitis: A clinical and microbial study

    Directory of Open Access Journals (Sweden)

    Nirima Oza

    2017-01-01

    Full Text Available Aims: The aim of the present study was to examine clinical types and microbiological flora isolated from angular chelitis. Materials and Methods: An eroded and/or erythematous, with or without fissure formation, nonvesicular lesion radiating from the angle of the mouth was considered to be angular chelitis. A sample of the present study comprised of 40 patients having unilateral or bilateral angular chelitis and 20 healthy individuals without any lip lesions. Clinical examination was done. In both test and control groups, the sample for microbial analysis was obtained from angle of the mouth. Results: Clinically, four types of angular cheilitis lesions were found, Type I, II, III, and IV. The most common type of lesion found was Type I lesion. Microorganisms isolated from the lesion were Staphylococcus aureus, Candida or Streptococci in 33 (82.5% cases either in pure culture or mixed culture. Among these 33 patients, S. aureus was found in 25 (75.5% cases, Candida in 16 (48.4% cases, and Streptococci in 5 (13.5% cases, respectively. Out of 16 cases positive for Candida, in 13 cases further isolation of Candida was possible. Candida albicans was found in 6 cases and Candida stellastodia in 7 cases. In majority of the dentulous and edentulous patients, S. aureus showed profuse growth. Conclusions: There are microorganisms associated with angular cheilitis.

  2. Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial: rationale and design

    Directory of Open Access Journals (Sweden)

    Schuler Gerhard

    2011-02-01

    Full Text Available Abstract Background Several studies have shown an association of cryptogenic stroke and embolism with patent foramen ovale (PFO, but the question how to prevent further events in such patients is unresolved. Options include antithrombotic treatment with warfarin or antiplatelet agents or surgical or endovascular closure of the PFO. The PC-Trial was set up to compare endovascular closure and best medical treatment for prevention of recurrent events. Methods The PC-Trial is a randomized clinical trial comparing the efficacy of percutaneous closure of the PFO using the Amplatzer PFO occluder with best medical treatment in patients with cryptogenic embolism, i.e. mostly cryptogenic stroke. Warfarin for 6 months followed by antiplatelet agents is recommended as medical treatment. Randomization is stratified according to patients age ( Discussion patients were randomized in 29 centers of Europe, Canada, and Australia. Randomization started February 2000. Enrollment of 414 patients was completed in February 2009. All patients will be followed-up longitudinally. Follow-up is maintained until the last enrolled patient is beyond 2.5 years of follow-up (expected in 2011. Trial Registration Trial listed in ClinicalTrials.gov as NCT00166257 and sponsored by AGA Medical, Plymouth, MN, USA

  3. Nondamaging Retinal Laser Therapy: Rationale and Applications to the Macula.

    Science.gov (United States)

    Lavinsky, Daniel; Wang, Jenny; Huie, Philip; Dalal, Roopa; Lee, Seung Jun; Lee, Dae Yeong; Palanker, Daniel

    2016-05-01

    Retinal photocoagulation and nondamaging laser therapy are used for treatment of macular disorders, without understanding of the response mechanism and with no rationale for dosimetry. To establish a proper titration algorithm, we measured the range of tissue response and damage threshold. We then evaluated safety and efficacy of nondamaging retinal therapy (NRT) based on this algorithm for chronic central serous chorioretinopathy (CSCR) and macular telangiectasia (MacTel). Retinal response to laser treatment below damage threshold was assessed in pigmented rabbits by expression of the heat shock protein HSP70 and glial fibrillary acidic protein (GFAP). Energy was adjusted relative to visible titration using the Endpoint Management (EpM) algorithm. In clinical studies, 21 eyes with CSCR and 10 eyes with MacTel were treated at 30% EpM energy with high spot density (0.25-diameter spacing). Visual acuity, retinal and choroidal thickness, and subretinal fluid were monitored for 1 year. At 25% EpM energy and higher, HSP70 was expressed acutely in RPE, and GFAP upregulation in Müller cells was observed at 1 month. Damage appeared starting at 40% setting. Subretinal fluid resolved completely in 81% and partially in 19% of the CSCR patients, and visual acuity improved by 12 ± 3 letters. Lacunae in the majority of MacTel patients decreased while preserving the retinal thickness, and vision improved by 10 letters. Heat shock protein expression in response to hyperthermia helps define the therapeutic window for NRT. Lack of tissue damage enables high-density treatment to boost clinical efficacy, therapy in the fovea, and retreatments to manage chronic diseases.

  4. A clinical study of papular urticaria

    International Nuclear Information System (INIS)

    Raza, N.; Lodhi, M.S.; Ali, L.

    2008-01-01

    To determine the clinical features and demographic profile of the patients having papular urticaria. Individuals of all age groups and either gender either suspected of or having definite history of insect bite were included in the study. A specially-designed proforma was filled for each patient separately. The proforma included demographic features, information regarding clothing and sleeping habits, personal or family history of atopy and clinical patterns of the lesions. Computer programme SPSS 10 was used to manage and analyze the data. Out of 280 patients, 201 (71.8%) were children upto 12 years of age, 178 (63.6%) were males, 91 (32.5%) had atopy, 194 (69.3%) were non-locals, 212 (75.7%) came from urban/peri-urban areas and 173 (61.8%) presented during May-August. Lesions were present over exposed parts of the body in 36 (12.9%), arranged in groups in 152 (54.3%) and were papular urticaria in 185 (66.1%) patients. Children, adult males, non-locals and those belonging to urban/peri-urban areas are more vulnerable to papular urticaria in a particular region. Papular and urticarial lesions arranged in groups over both exposed as well as covered body parts of a single patient is the most common clinical pattern. (author)

  5. Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial: study protocol, rationale and feasibility of a randomised multicentre trial

    Directory of Open Access Journals (Sweden)

    Vester-Andersen Morten

    2013-02-01

    Full Text Available Abstract Background Emergency abdominal surgery carries a 15% to 20% short-term mortality rate. Postoperative medical complications are strongly associated with increased mortality. Recent research suggests that timely recognition and effective management of complications may reduce mortality. The aim of the present trial is to evaluate the effect of postoperative intermediate care following emergency major abdominal surgery in high-risk patients. Methods and design The InCare trial is a randomised, parallel-group, non-blinded clinical trial with 1:1 allocation. Patients undergoing emergency laparotomy or laparoscopic surgery with a perioperative Acute Physiology and Chronic Health Evaluation II score of 10 or above, who are ready to be transferred to the surgical ward within 24 h of surgery are allocated to either intermediate care for 48 h, or surgical ward care. The primary outcome measure is all-cause 30-day mortality. We aim to enrol 400 patients in seven Danish hospitals. The sample size allows us to detect or refute a 34% relative risk reduction of mortality with 80% power. Discussion This trial evaluates the benefits and possible harm of intermediate care. The results may potentially influence the survival of many high-risk surgical patients. As a pioneer trial in the area, it will provide important data on the feasibility of future large-scale randomised clinical trials evaluating different levels of postoperative care. Trial registration Clinicaltrials.gov identifier: NCT01209663

  6. Operationalizing "trance". I: Rationale and research using a psychophenomenological approach.

    Science.gov (United States)

    Pekala, R J; Kumar, V K

    2000-10-01

    Despite the popularity of the term "trance" among clinicians to describe the subjective effects associated with being hypnotized, heretofore there has been no means to operationalize that definition. The authors present a rationale and psychophenomenological method to operationalize the term "trance" in terms of (a) hypnotic depth, a quantitative measure of subjective trance assessed via a pHGS (predicted Harvard Group Scale) score, derived from regression analysis, and (b) "trance typology profiles," a qualitative differentiation of empirically derived (via cluster and discriminant analyses) categories of subjective trance experiences. The authors then discuss theoretical and clinical implications of this psychophenomenological approach for developing an operational definition of the concept of trance.

  7. A clinical and investigational study of donovanosis

    Directory of Open Access Journals (Sweden)

    Veeranna S

    2003-03-01

    Full Text Available A clinical and investigational study of 25 cases of Donovanosis was undertaken. The incidence was found to be 1.53% of all STD cases and 2.9% of GUD. M:F ratio was 2.12:1. Incidence was more in unmarried people. Fleshy exuberant type was seen in 88% of cases. Two patients (8% had extragenital ulcers. Donovan bodies were found in 88%. Pseudo elephantiasis was seen in 8 patients. Biopsy was done in 8 cases and showed ocanthosis, plasma cell infiltration and pseudo epitheliomatous hyperplasia. One patient developed squamous cell carcinoma of vulva.

  8. Educational Rationale Metadata for Learning Objects

    Directory of Open Access Journals (Sweden)

    Tom Carey

    2002-10-01

    Full Text Available Instructors searching for learning objects in online repositories will be guided in their choices by the content of the object, the characteristics of the learners addressed, and the learning process embodied in the object. We report here on a feasibility study for metadata to record process-oriented information about instructional approaches for learning objects, though a set of Educational Rationale [ER] tags which would allow authors to describe the critical elements in their design intent. The prototype ER tags describe activities which have been demonstrated to be of value in learning, and authors select the activities whose support was critical in their design decisions. The prototype ER tag set consists descriptors of the instructional approach used in the design, plus optional sub-elements for Comments, Importance and Features which implement the design intent. The tag set was tested by creators of four learning object modules, three intended for post-secondary learners and one for K-12 students and their families. In each case the creators reported that the ER tag set allowed them to express succinctly the key instructional approaches embedded in their designs. These results confirmed the overall feasibility of the ER tag approach as a means of capturing design intent from creators of learning objects. Much work remains to be done before a usable ER tag set could be specified, including evaluating the impact of ER tags during design to improve instructional quality of learning objects.

  9. Clinic-Radiological Study of facial paralysis

    International Nuclear Information System (INIS)

    Olier, J.; Bacaicoa, M.C.; Guridi, J.; Gil, J.L.; Elcarte, F.; Delgado, G.

    1992-01-01

    We have gathered 159 cases of facial paralysis from recent records in our hospital, including paralyses of central as well as peripheral origin, and presenting as the only symptom or as one of several major symptoms of the discomfort of each patient. Sixty-four percent of them were studied by CT scan and/or MR, confirming the existence of alterations in the pathway of nerve pair VII in 50% of the patients who underwent radiological study. Idiopathic facial paralysis was the most common type (42% of the total); while tumors and post-traumatic findings were the most constant radiological findings. From the analysis of the data, the importance of the clinical criteria for selection of the patients in the study and the protocol for radiological diagnosis employed can be deduced. (author)

  10. Rationale and design of WEBCARE

    DEFF Research Database (Denmark)

    Pedersen, Susanne S.; Spek, Viola; Theuns, Dominic A M J

    2009-01-01

    The implantable cardioverter defibrillator (ICD) is generally well accepted, but 25-33% of patients experience clinical levels of anxiety, depression, and impaired quality of life (QoL) following implantation. Few trials in ICD patients have investigated whether behavioral intervention may mitiga...

  11. Rationale and design of ARTS

    DEFF Research Database (Denmark)

    Pitt, Bertram; Filippatos, Gerasimos; Gheorghiade, Mihai

    2012-01-01

    . placebo (primary endpoint) and vs. spironolactone, safety and tolerability, biomarkers of cardiac and renal function or injury, eGFR, and albuminuria. BAY 94-8862 pharmacokinetics are also assessed. Perspectives ARTS is the first phase II clinical trial of BAY 94-8862 and is expected to provide a wealth...

  12. Clinical and neuroradiological studies on internuclear ophthalmoplegia

    Energy Technology Data Exchange (ETDEWEB)

    Ito, Michiko; Uchiyama, Shinichiro; Endo, Riuko; Aikawa, Takashi; Kobayashi, Itsuro; Takemiya, Toshiko; Maruyama, Shoichi (Tokyo Women' s Medical Coll. (Japan))

    1989-06-01

    In this study 14 cases of internuclear ophthalmoplegia (INO) were analysed. The correlation of clinical symptoms with localization of the responsible lesions was studied in these patients. The subjects included 9 patients with CVD, 2 with MS, 1 with Fisher's syndrome, 1 with cranial polyneuritis and one with unknown etiology. Nine patients with unilateral INO are all associated with brainstem infarction. The other 5 patients including 2 MS had bilateral INO. CT showed abnormal findings in brain stem in 7 out of 14 patients. As for MRI an abnormality was found in 5 out of the 8 patients examined. Two of the 7 patients without any abnormality on CT had abnormal signals on MRI. We divided INO into 3 groups based on the clinical symptoms: (1) anterior type in which convergence was involved concomitantly with adduction paralysis, (2) typical type in which dissociated nystagmus was more marked in the abducting eye, and convergence was preserved, (3) posterior type in which abduction is impaired without adduction disturbance. There were 5 cases of anterior type, 9 of typical type, and none of posterior type. On MRI two patients of anterior type had abnormalities in the dorsal midbrain, and one patient had an abnormality in the pons, and two patients of typical type had abnormalities in the upper or middle dorsal pons to the dorsal midbrain. CT failed to demontrate any responsible lesions in 2 patients in whom the responsible legions were clearly identified on MRI. (J.P.N.).

  13. A CLINICAL STUDY ON BLUNT INJURY ABDOMEN

    Directory of Open Access Journals (Sweden)

    G. Kishore Babu

    2016-10-01

    Full Text Available BACKGROUND Abdominal trauma continues to account for a large number of trauma-related injuries and deaths. Motor vehicle accidents and urban violence, respectively, are the leading causes of blunt and penetrating trauma to this area of the body. Unnecessary deaths and complications can be minimized by improved resuscitation, evaluation and treatment. The new techniques and diagnostic tools available are important in the management of abdominal trauma. These improved methods, however, still depend on experience and clinical judgment for application and determination of the best care for the injured patient. The aim of the study is to 1. Analyse the incidence, clinical characteristics, diagnosis, indications for laparotomy, therapeutic methods and morbidity & mortality rates. 2. To study nature of blunt abdominal trauma. 3. To assess patient for surgical intervention and to avoid negative laparotomy. 4. To assess morbidity rate in different organs injury. 5. To evaluate modalities of treatment, complications and prognosis. MATERIALS AND METHODS This study is a prospective study on 97 patients with Blunt injuries to the abdomen admitted in S.V.R.R.G.G. Hospital, Tirupati during October 2013-15. Inclusion Criteria Patients > 13 years, with Blunt injury to abdomen either by RTA, fall, object contact, assault giving written informed consent. Exclusion Criteria Patients <13 yrs. Blunt injuries due to blasts, patients with severe cardiothoracic and head injuries who are hemodynamically unstable. CONCLUSION Blunt Trauma to abdomen is on rise due to excessive use of motor vehicles. It poses a therapeutic and diagnostic dilemma for the attending surgeon due to wide range of clinical manifestations ranging from no early physical findings to progression to shock. So, the Trauma surgeon should rely on his physical findings in association with use of modalities like x-ray abdomen, USG abdomen and abdominal paracentesis. Hollow viscus perforations are

  14. Korean Clinic Based Outcome Measure Studies

    Directory of Open Access Journals (Sweden)

    Jongbae Park

    2003-02-01

    Full Text Available Background: Evidence based medicine has become main tools for medical practice. However, conducting a highly ranked in the evidence hierarchy pyramid is not easy or feasible at all times and places. There remains a room for descriptive clinical outcome measure studies with admitting the limit of the intepretation. Aims: Presents three Korean clinic based outcome measure studies with a view to encouraging Korean clinicians to conduct similar studies. Methods: Three studies are presented briefly here including 1 Quality of Life of liver cancer patients after 8 Constitutional acupuncture; 2 Developing a Korean version of Measuring yourself Medical Outcome profile (MYMOP; and 3 Survey on 5 Shu points: a pilot In the first study, we have included 4 primary or secondary liver cancer patients collecting their diagnostic X-ray film and clinical data f개m their hospital, and asked them to fill in the European Organization Research and Treatment of Cancer, Quality of Life Questionnaire before the commencement of the treatment. The acupuncture treatment is set up format but not disclosed yet. The translation and developing a Korean version of outcome measures that is Korean clinician friendly has been sought for MYMOP is one of the most appropriate one. The permission was granted, the translation into Korean was done, then back translated into English only based on the Korean translation by the researcher who is bilingual in both languages. The back translation was compared by the original developer of MYMOP and confirmed usable. In order to test the existence of acupoints and meridians through popular forms of Korean acupuncture regimes, we aim at collecting opinions from 101 Korean clinicians that have used those forms. The questions asked include most effective symptoms, 5 Shu points, points those are least likely to use due to either adverse events or the lack of effectiveness, theoretical reasons for the above proposals, proposing outcome measures

  15. Clinical studies on mercury poisoning in cattle

    Energy Technology Data Exchange (ETDEWEB)

    Sonoda, M; Nakamura, R; Too, K; Matsuhashi, A; Ishimoto, H; Sasaki, R; Ishida, K; Takahashi, M

    1956-01-01

    A sporadic outbreak of an unknown disease occurred among dairy cattle, from early February to late May 1955, in Japan. The characteristic symptoms of this disease were dyspnea and depilation; out of 29 cases, 8 died while 2 were slaughtered. Clinical studies have disclosed that the symptoms were similar to those found in cases of mercury poisoning as described by others. So the animals' feed was suspected of being the cause of the sickness. It was confirmed that the incident was due to poisoning resulting from ingestion of linseed meal treated with a mercurial fungicide. From the results of the testing anamnesis, it was found that 171 cattle were fed with the meal and 29 cases were affected. In veiw of the wide use of mercurial preparations for treating seed grains against fungi infection, a further experimental study was made on the effects of the feed and fungicide upon calves.

  16. Clinical and radiologic study of odontogenic keratocyst

    International Nuclear Information System (INIS)

    Kim, Sang Rae; Park, Tae Won

    1984-01-01

    The purpose of this article is to define further clinical behaviors and radiographic appearances of odontogenic keratocyst developed in jaws, with special interest in recurrent rate which is generally high. 32 patients whose microscopic examinations were verified as odontogenic keratocyst were examined in this study. The results of this study were as follows. 1. There was an apparent sex predilection for male. 2. The peak incidence was the second and third decades with gradual decline thereafter with a mean age of 31 years 7 months. 3. The most common site was a mandibular molar-ramus region, 22 cases (68.8%) occurred in the mandible and 10 cases (31.3%) in the maxilla.

  17. Clinical and radiologic study of odontogenic keratocyst

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Sang Rae; Park, Tae Won [Department of Radiology, College of Dentistry, Seoul National University, Seoul (Korea, Republic of)

    1984-11-15

    The purpose of this article is to define further clinical behaviors and radiographic appearances of odontogenic keratocyst developed in jaws, with special interest in recurrent rate which is generally high. 32 patients whose microscopic examinations were verified as odontogenic keratocyst were examined in this study. The results of this study were as follows. 1. There was an apparent sex predilection for male. 2. The peak incidence was the second and third decades with gradual decline thereafter with a mean age of 31 years 7 months. 3. The most common site was a mandibular molar-ramus region, 22 cases (68.8%) occurred in the mandible and 10 cases (31.3%) in the maxilla.

  18. The effects of baroreflex activation therapy on blood pressure and sympathetic function in patients with refractory hypertension: the rationale and design of the Nordic BAT study.

    Science.gov (United States)

    Gordin, Daniel; Fadl Elmula, Fadl Elmula M; Andersson, Bert; Gottsäter, Anders; Elf, Johan; Kahan, Thomas; Christensen, Kent Lodberg; Vikatmaa, Pirkka; Vikatmaa, Leena; Bastholm Olesen, Thomas; Groop, Per-Henrik; Olsen, Michael Hecht; Tikkanen, Ilkka

    2017-10-01

    To explore the effects of baroreflex activation therapy (BAT) on hypertension in patients with treatment resistant or refractory hypertension. This investigator-initiated randomized, double-blind, 1:1 parallel-design clinical trial will include 100 patients with refractory hypertension from 6 tertiary referral hypertension centers in the Nordic countries. A Barostim Neo System will be implanted and after 1 month patients will be randomized to either BAT for 16 months or continuous pharmacotherapy (BAT off) for 8 months followed by BAT for 8 months. A second randomization will take place after 16 months to BAT or BAT off for 3 months. Eligible patients have a daytime systolic ambulatory blood pressure (ABPM) of  ≥145 mm Hg, and/or a daytime diastolic ABPM of  ≥95 mm Hg after witnessed drug intake (including  ≥3 antihypertensive drugs, preferably including a diuretic). The primary end point is the reduction in 24-hour systolic ABPM by BAT at 8 months, as compared to pharmacotherapy. Secondary and tertiary endpoints are effects of BAT on home and office blood pressures, measures of indices of cardiac and vascular structure and function during follow-up, and safety. This academic initiative will increase the understanding of mechanisms and role of BAT in the refractory hypertension.

  19. Evidence Based Studies in Clinical Transfusion Medicine

    NARCIS (Netherlands)

    A.J.G. Jansen (Gerard)

    2007-01-01

    textabstractAfter the introduction of blood component therapy in the 1960s, more and more attention is given to clinical transfusion medicine. Although blood transfusion is an important treatment in different clinical settings, there are still lack of much randomized clinical trials. Nowadays

  20. Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: Rationale and design of the GALILEO study.

    Science.gov (United States)

    Windecker, Stephan; Tijssen, Jan; Giustino, Gennaro; Guimarães, Ana H C; Mehran, Roxana; Valgimigli, Marco; Vranckx, Pascal; Welsh, Robert C; Baber, Usman; van Es, Gerrit-Anne; Wildgoose, Peter; Volkl, Albert A; Zazula, Ana; Thomitzek, Karen; Hemmrich, Melanie; Dangas, George D

    2017-02-01

    Optimal antithrombotic treatment after transcatheter aortic valve replacement (TAVR) is unknown and determined empirically. The direct factor Xa inhibitor rivaroxaban may potentially reduce TAVR-related thrombotic complications and premature valve failure. GALILEO is an international, randomized, open-label, event-driven, phase III trial in more than 1,520 patients without an indication for oral anticoagulation who underwent a successful TAVR (ClinicalTrials.govNCT02556203). Patients are randomized (1:1 ratio), 1 to 7days after a successful TAVR, to either a rivaroxaban-based strategy or an antiplatelet-based strategy. In the experimental arm, subjects receive rivaroxaban (10mg once daily [OD]) plus acetylsalicylic acid (ASA, 75-100mg OD) for 90days followed by rivaroxaban alone. In the control arm, subjects receive clopidogrel (75mg OD) plus ASA (as above) for 90days followed by ASA alone. In case new-onset atrial fibrillation occurs after randomization, full oral anticoagulation will be implemented with maintenance of the original treatment assignment. The primary efficacy end point is the composite of all-cause death, stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep venous thrombosis, and systemic embolism. The primary safety end point is the composite of life-threatening, disabling, and major bleeding, according to the Valve Academic Research Consortium definitions. GALILEO will test the hypothesis that a rivaroxaban-based antithrombotic strategy reduces the risk of thromboembolic complications post-TAVR with an acceptable risk of bleeding compared with the currently recommended antiplatelet therapy-based strategy in subjects without need of chronic oral anticoagulation. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  1. Experimental and clinical studies on CT lymphography

    International Nuclear Information System (INIS)

    Hirata, Yuzo; Kono, Michio

    1982-01-01

    Indirect lymphography using computed tomographic apparatus (CT Lymphography) was attempted in 15 dogs with newly devised contrast medium for the opacification of hilar and mediastinal lymphnodes. Clinical application was performed in 2 cases of lung cancer. Newly devised contrast material is an emulsion, which consists of oily contrast medium, non-ionic surfactant and glucose solution. The contrast medium was injected percutaneously into subdiaphragmatic space, or into bronchial walls by bronchofiberscopic technique. CT was able to demonstrate the opacified hilar and mediastinal nodes much more in number than demonstrated in conventional radiograms. It was true in 6 to 11 cases when injected into subdiaphragmatic spaces, and in 2 of 4 cases with an injection into bronchial walls. In clinical studies, CT revealed opacification of mediastinal nodes in one case of lung cancer. Although the procedure is still inferior to the demonstrability of routine indirect lymphography for the evaluation of the fine structure of each node, it showed no remarkable side effects. As the satisfactory method of opacifying hilar and mediastinal nodes has not yet been established, our method is thought to be of value in applying for detection of the metastatic lymphnodes. (author)

  2. Controlled outcome studies of child clinical hypnosis.

    Science.gov (United States)

    Adinolfi, Barbara; Gava, Nicoletta

    2013-09-01

    Background Hypnosis is defined as "as an interaction in which the hypnotist uses suggested scenarios ("suggestions") to encourage a person's focus of attention to shift towards inner experiences". Aim of the work The focus of this review is to summarize the findings of controlled outcome studies investigating the potential of clinical hypnosis in pediatric populations. We will examine the following themes: anesthesia, acute and chronic pain, chemotherapy-related distress, along with other specific medical issues. Results Hypnosis is an effective method to reduce pain and anxiety before, during and after the administration of anesthetics, during local dental treatments, invasive medical procedures and in burn children. Hypnosis can be successfully used to manage recurrent headaches, abdominal pain, irritable bowel syndrome and chemotherapy-related distress. Hypnosis has an important role in managing symptoms and improving the quality of life of children suffering from asthma and cystic fibrosis and in facilitating the treatment of insomnia in school-age children. Finally, hypnosis can be effectively used for the treatment of some habitual disorders such as nocturnal enuresis and dermatologic conditions, including atopic dermatitis and chronic eczema Conclusions Clinical hypnosis seems to be a useful, cheap and side-effects free tool to manage fear, pain and several kinds of stressful experiences in pediatric populations. Children who receive self-hypnosis trainings achieve significantly greater improvements in their physical health, quality of life, and self-esteem.

  3. The Restoration of Chronotropic CompEtence in Heart Failure PatientS with Normal Ejection FracTion (RESET) Study: Rationale and Design

    Science.gov (United States)

    Kass, David A.; Kitzman, Dalane W.; Alvarez, Guy E.

    2009-01-01

    Background Heart failure with preserved ejection fraction (HFpEF) is the predominant form of HF among the elderly and in women. However, there are few if any evidence-based therapeutic options for HFpEF. The chief complaint of HFpEF is reduced tolerance to physical exertion. Recent data revealed that one potential mechanism of exertional intolerance in HFpEF patients is inadequate chronotropic response. Although there is considerable evidence demonstrating the benefits of rate-adaptive pacing (RAP) provided from implantable cardiac devices in patients with an impaired chronotropic response, the effect of RAP in HFpEF is unknown. Methods and Results The RESET study is a prospective, multi-center, double-blind, randomized with stratification, study assessing the effect of RAP on peak VO2 and quality of life. RAP therapy will be evaluated in a cross-over paired fashion for each patient within each study stratum. Study strata are based on patient beta-blocker usage at time of enrollment. The study is powered to assess the impact of pacing independently in both strata. Conclusions The RESET study seeks to evaluate the potential benefit of RAP in patients with symptomatic mild to moderate HFpEF and chronotropic impairment. Study enrollment began in July 2008. PMID:20123314

  4. Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO) using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial): rationale and design.

    Science.gov (United States)

    Khattab, Ahmed A; Windecker, Stephan; Jüni, Peter; Hildick-Smith, David; Dudek, Dariusz; Andersen, Henning R; Ibrahim, Reda; Schuler, Gerhard; Walton, Antony S; Wahl, Andreas; Mattle, Heinrich P; Meier, Bernhard

    2011-02-28

    Several studies have shown an association of cryptogenic stroke and embolism with patent foramen ovale (PFO), but the question how to prevent further events in such patients is unresolved. Options include antithrombotic treatment with warfarin or antiplatelet agents or surgical or endovascular closure of the PFO. The PC-Trial was set up to compare endovascular closure and best medical treatment for prevention of recurrent events. The PC-Trial is a randomized clinical trial comparing the efficacy of percutaneous closure of the PFO using the Amplatzer PFO occluder with best medical treatment in patients with cryptogenic embolism, i.e. mostly cryptogenic stroke. Warfarin for 6 months followed by antiplatelet agents is recommended as medical treatment. Randomization is stratified according to patients age (Australia. Randomization started February 2000. Enrollment of 414 patients was completed in February 2009. All patients will be followed-up longitudinally. Follow-up is maintained until the last enrolled patient is beyond 2.5 years of follow-up (expected in 2011).

  5. A clinical study of geriatric dermatoses

    Directory of Open Access Journals (Sweden)

    Leena Raveendra

    2014-07-01

    Full Text Available Introduction: The geriatric population is composed of persons over 65 years of age and very few studies are available on the dermatologic diseases in this group. This study was done to study the spectrum of cutaneous manifestations and prevalence of physiological and pathological changes in the skin of elderly people. Material and Methods: Two hundred consecutive patients aged more than 65 years of age attending the outpatient clinic or admitted as inpatients in the Department of Dermatology at Vydehi Institute of Medical Sciences and Research Centre were subjects for the study. A detailed history of cutaneous complaints, present and past medical ailments was taken. A complete general physical, systemic examination and dermatological examination was done and all findings were noted in a pre designed proforma. Skin changes observed due to ageing were classified as physiological and pathological. Findings were collated in a master chart and results analyzed. Results: Out of 200 patients studied, 71% were males and 29% were females. Pruritus was the single most common complaint elicited (44%. Among the physiological changes, xerosis was the commonest (93%. Among the pathological changes skin tumours, eczemas, infections were the common findings. Conclusions: The geriatric dermatoses are different in different populations as some of the skin changes seen in western skin and Indian skin are not identical.

  6. The effect of a vegan versus AHA DiEt in coronary artery disease (EVADE CAD trial: Study design and rationale

    Directory of Open Access Journals (Sweden)

    Binita Shah

    2017-12-01

    Conclusion: This study is the first to comprehensively assess multiple indices of inflammation and glucometabolic profile in a rigorously conducted randomized trial of patients with CAD on a vegan versus AHA-recommended diet.

  7. Hormones, Nicotine and Cocaine: Clinical Studies

    Science.gov (United States)

    Mello, Nancy K.

    2009-01-01

    Nicotine and cocaine each stimulate hypothalamic-pituitary-adrenal and -gonadal axis hormones, and there is increasing evidence that the hormonal milieu may modulate the abuse-related effects of these drugs. This review summarizes some clinical studies of the acute effects of cigarette smoking or IV cocaine on plasma drug and hormone levels, and subjective effects ratings. The temporal covariance between these dependent measures was assessed with a rapid (two min) sampling procedure in nicotine-dependent volunteers or current cocaine users. Cigarette smoking and IV cocaine each stimulated a rapid increase in LH and ACTH, followed by gradual increases in cortisol and DHEA. Positive subjective effects ratings increased immediately after initiation of cigarette smoking or IV cocaine administration. However, in contrast to cocaine’s sustained positive effects (hormones on nicotine dependence and cocaine abuse, and implications for treatment of these addictive disorders is discussed. PMID:19835877

  8. Rationale and design for the Asia BP@Home study on home blood pressure control status in 12 Asian countries and regions.

    Science.gov (United States)

    Kario, Kazuomi; Tomitani, Naoko; Buranakitjaroen, Peera; Chen, Chen-Huan; Chia, Yook-Chin; Divinagracia, Romeo; Park, Sungha; Shin, Jinho; Siddique, Saulat; Sison, Jorge; Soenarta, Arieska Ann; Sogunuru, Guru Prasad; Tay, Jam Chin; Turana, Yuda; Wang, Ji-Guang; Wong, Lawrence; Zhang, Yuqing; Wanthong, Sirisawat; Hoshide, Satoshi; Kanegae, Hiroshi

    2018-01-01

    Home blood pressure (BP) monitoring is endorsed in multiple guidelines as a valuable adjunct to office BP measurements for the diagnosis and management of hypertension. In many countries throughout Asia, physicians are yet to appreciate the significant contribution of BP variability to cardiovascular events. Furthermore, data from Japanese cohort studies have shown that there is a strong association between morning BP surge and cardiovascular events, suggesting that Asians in general may benefit from more effective control of morning BP. We designed the Asia BP@Home study to investigate the distribution of hypertension subtypes, including white-coat hypertension, masked morning hypertension, and well-controlled and uncontrolled hypertension. The study will also investigate the determinants of home BP control status evaluated by the same validated home BP monitoring device and the same standardized method of home BP measurement among 1600 or more medicated patients with hypertension from 12 countries/regions across Asia. ©2017 Wiley Periodicals, Inc.

  9. Kelston Beverages Pilot Study: Rationale, design and implementation of a community and school based intervention to reduce sugary drink consumption among children and youth.

    Science.gov (United States)

    Sundborn, G; Ni Mhurchu, C; Ness, C; Latu, H; Jackson, R

    2014-03-01

    The Kelston Beverages Study was designed to increase awareness of the sugar content of sugary drinks, the poor health consequences that high intake of these drinks have, and inform on ways to reduce intake of students. The aims of this pilot study were to refine interventions and processes designed to raise awareness of the harms that sugar sweetened beverages (SSBs) have on health, and to reduce their consumption among the youth of a small West Auckland suburb. There were three arms to this interventional study, one in schools, another in community organisations (churches, sports clubs and community groups), and the final arm is in the local retail sector. The school arm was the most extensive component and initially involved a survey of children's knowledge and consumption of sugar sweetened beverages (SSBs) using a brief questionnaire. The study evaluated any SSB policies in schools and for schools that did not have policies, opportunities were scoped to develop and implement them; a canteen AUDIT focussed particularly on beverages was carried out; and finally a student partnered social marketing exercise was undertaken that comprised 2 competitions, one to design a poster, and another to write and perform a rap. Children were re-surveyed at the completion of the intervention (7 months later) to determine change in knowledge and self-reported consumption of SSBs. Both the community organisations and retail arms of this study focussed on raising awareness into the harmful effects of SSBs and establishing healthy beverage policy in the respective organisations. Promising results with regards to acceptability, feasibility, and recruitment as well as valuable learnings with regard to process support the development of a proposal to conduct a cluster randomised trial of the interventions successfully tested in this pilot study.

  10. Experimental and clinical studies with intraoperative radiotherapy

    International Nuclear Information System (INIS)

    Sindelar, W.F.; Kinsella, T.; Tepper, J.; Travis, E.L.; Rosenberg, S.A.; Glatstein, E.

    1983-01-01

    Studies of normal tissue tolerance to intraoperative radiotherapy were done upon 65 dogs subjected to laparotomy and 11 million electron volt electron irradiation in doses ranging from zero to 5,000 rads. Results of studies indicated that intact aorta and vena cava tolerate up to 5,000 rads without loss of structural integrity. Ureteral fibrosis and stenosis develop at doses of 3,000 rads or more. Arterial anastomoses heal after doses of 4,500 rads, but fibrosis can lead to occlusion. Intestinal suture lines heal after doses of 4,500 rads. Bile duct fibrosis and stenosis develop at doses of 2,000 rads or more. Biliary-enteric anastomoses fail to heal at any dose level. A clinical trial of intraoperative radiotherapy combined with radical surgery was performed upon 20 patients with advanced malignant tumors which were considered unlikely to be cured by conventional therapies and which included carcinomas of the stomach, carcinomas of the pancreas, carcinomas involving the hilus of the liver, retroperitoneal sarcomas and osteosarcomas of the pelvis. All patients underwent resection of gross tumor, followed by intraoperative irradiation of the tumor bed and regional nodal basins. Some patients received additional postoperative external beam radiotherapy. Treatment mortality for combined operation and radiotherapy occurred in four of 20 patients. Postoperative complications occurred in four of the 16 surviving patients. Local tumor control was achieved in 11 of the 16 surviving patients, with an over-all median follow-up period of 18 months. The clinical trial suggested that intraoperative radiotherapy is a feasible adjunct to resection in locally advanced tumors, that the resulting mortality and morbidity is similar to that expected from operation alone and that local tumor control may be improved

  11. Rationales for the Lightning Launch Commit Criteria

    Science.gov (United States)

    Willett, John C. (Editor); Merceret, Francis J. (Editor); Krider, E. Philip; O'Brien, T. Paul; Dye, James E.; Walterscheid, Richard L.; Stolzenburg, Maribeth; Cummins, Kenneth; Christian, Hugh J.; Madura, John T.

    2016-01-01

    Since natural and triggered lightning are demonstrated hazards to launch vehicles, payloads, and spacecraft, NASA and the Department of Defense (DoD) follow the Lightning Launch Commit Criteria (LLCC) for launches from Federal Ranges. The LLCC were developed to prevent future instances of a rocket intercepting natural lightning or triggering a lightning flash during launch from a Federal Range. NASA and DoD utilize the Lightning Advisory Panel (LAP) to establish and develop robust rationale from which the criteria originate. The rationale document also contains appendices that provide additional scientific background, including detailed descriptions of the theory and observations behind the rationales. The LLCC in whole or part are used across the globe due to the rigor of the documented criteria and associated rationale. The Federal Aviation Administration (FAA) adopted the LLCC in 2006 for commercial space transportation and the criteria were codified in the FAA's Code of Federal Regulations (CFR) for Safety of an Expendable Launch Vehicle (Appendix G to 14 CFR Part 417, (G417)) and renamed Lightning Flight Commit Criteria in G417.

  12. A CLINICAL STUDY OF HELLP SYNDROME

    Directory of Open Access Journals (Sweden)

    Irrinki Vasundhara Jyothi

    2017-01-01

    Full Text Available BACKGROUND HELLP syndrome is an acronym for Haemolysis (H, Elevated Liver Enzymes (EL and Low Platelet (LP. This is a rare complication of preeclampsia (10-15%. HELLP syndrome may develop even without hypertension. This syndrome is manifested by nausea, vomiting, epigastric or right upper quadrant pain along with haematological changes. Parenchymal necrosis of liver causes elevation in hepatic enzymes (AST and ALT >70 IU/L, LDH >600 IU/L and bilirubin (>1.2 mg/dL. There may be subcapsular haematoma formation (which is diagnosed by CT scanning and abnormal peripheral blood smear. Eventually, liver may rupture to cause sudden hypotension due to haemoperitoneum. Periportal haemorrhagic necrosis of the liver occurs due to thrombosis of the arterioles. The necrosis is seen at the periphery of the lobule. There may be subcapsular haemorrhage. Hepatic insufficiency seldom occurs because of the capacity and regenerative ability of liver cells. Liver function tests are especially abnormal in women with HELLP syndrome. A sincere effort has been put to study the HELLP syndrome incidence and its clinical prognosis and to understand its outcome. MATERIALS AND METHODS Forty patients were selected whose BP was recorded more than 140/80 mmHg after twenty weeks of gestation. Peripheral smear were taken to check for haemolysis or elevated indirect bilirubin or elevated LDH levels were checked, elevated liver enzymes and decreased platelet count <1,00,000/cumm was noted. Incidence of HELLP syndrome was found and various clinical features presented and the complications faced by the patients were recorded. Prompt treatment was given and the outcome of the disease was noted. All the statistical analysis was done using the latest SPSS software 2015 (California. RESULTS The mean age of the study group was found to be 26.72 years with a standard deviation of 5.62 years. In our study, the mean haemoglobin level was found to be 6.41 gm%, which is very low compared to the

  13. Organ Donation in the 50+ Age Demographic: Survey Results on Decision Rationale and Information Preferences.

    Science.gov (United States)

    Tartaglia, Alexander; Dodd-McCue, Diane; Myer, Kevin A; Mullins, Andrew

    2016-09-01

    The rate of organ donation by older potential donors is significantly declining even though recent studies show positive clinical outcomes with organs transplanted from older donors. This study examined the 50+ age demographic to identify the rationale for donation decisions, preferred media methods of donation information delivery, and responsiveness to an age-tailored donation message. Results from 579 surveys, 87% from the 50+ age demographic, found respondents prone to self-select themselves as medically ineligible based on current medication and health status, even though they might be medically suitable donors. Their incentive to pursue additional information on donation is limited except when motivated by personal accounts within their families and communities. In addition, even when computer literate, they continue to favor the printed or spoken word for donation information delivery. The results suggest an opportunity for those working with older adults to develop more personalized, localized donation education programs targeting this age demographic. © The Author(s) 2014.

  14. Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study (APPROACH-IS): rationale, design, and methods

    NARCIS (Netherlands)

    Apers, Silke; Kovacs, Adrienne H.; Luyckx, Koen; Alday, Luis; Berghammer, Malin; Budts, Werner; Callus, Edward; Caruana, Maryanne; Chidambarathanu, Shanthi; Cook, Stephen C.; Dellborg, Mikael; Enomoto, Junko; Eriksen, Katrine; Fernandes, Susan M.; Jackson, Jamie L.; Johansson, Bengt; Khairy, Paul; Kutty, Shelby; Menahem, Samuel; Rempel, Gwen; Sluman, Maayke A.; Soufi, Alexandra; Thomet, Corina; Veldtman, Gruschen; Wang, Jou-Kou; White, Kamila; Moons, Philip; Maisuls, Héctor; Cabrera, Marcelo; Eaton, Sarah; Larion, Ruth; FengWang, Qi; van Deyk, Kristien; Goossens, Eva; Rassart, Jessica; Mackie, Andrew; Ballantyne, Ross; Rankin, Kathryn; Norris, Colleen; Taylor, Dylan; Vondermuhll, Isabelle; Windram, Jonathan; Heggie, Pamela; Lasiuk, Gerri; Proietti, Anna; Dore, Annie; Mercier, Lise-Andrée; Mongeon, François-Pierre; Marcotte, François; Mulder, Barbara

    2015-01-01

    Data on patient-reported outcomes (PROs) in adults with congenital heart disease (CHD) are inconsistent and vary across the world. Better understanding of PROs and their differences across cultural and geographic barriers can best be accomplished via international studies using uniform research

  15. Rationale, design and baseline characteristics of the CANagliflozin cardioVascular Assessment Study-Renal (CANVAS-R) : A randomized, placebo-controlled trial

    NARCIS (Netherlands)

    Neal, Bruce; Perkovic, Vlado; Matthews, David R.; Mahaffey, Kenneth W.; Fulcher, Greg; Meininger, Gary; Erondu, Ngozi; Desai, Mehul; Shaw, Wayne; Vercruysse, Frank; Yee, Jacqueline; Deng, Hsiaowei; de Zeeuw, Dick

    Aims: The primary aim of the CANagliflozin cardioVascular Assessment Study-Renal (CANVAS-R) is to determine whether the favourable effects of inhibition of the sodium glucose co-transporter 2 (SGLT2) on blood glucose, blood pressure and body weight are accompanied by protection against adverse renal

  16. The Effect of a Vegan versus AHA DiEt in Coronary Artery Disease (EVADE CAD) trial: study design and rationale.

    Science.gov (United States)

    Shah, Binita; Ganguzza, Lisa; Slater, James; Newman, Jonathan D; Allen, Nicole; Fisher, Edward; Larigakis, John; Ujueta, Francisco; Gianos, Eugenia; Guo, Yu; Woolf, Kathleen

    2017-12-01

    Multiple studies demonstrate the benefit of a vegan diet on cardiovascular risk factors when compared to no intervention or usual dietary patterns. The aim of this study is to evaluate the effect of a vegan diet versus the American Heart Association (AHA)-recommended diet on inflammatory and glucometabolic profiles in patients with angiographically defined coronary artery disease (CAD). This study is a randomized, open label, blinded end-point trial of 100 patients with CAD as defined by ≥50% diameter stenosis in a coronary artery ≥2 mm in diameter on invasive angiography. Participants are randomized to 8 weeks of either a vegan or AHA-recommended diet (March 2014 and February 2017). Participants are provided weekly groceries that adhere to the guidelines of their diet. The primary endpoint is high sensitivity C-reactive concentrations. Secondary endpoints include anthropometric data, other markers of inflammation, lipid parameters, glycemic markers, endothelial function, quality of life data, and assessment of physical activity. Endpoints are measured at each visit (baseline, 4 weeks, and 8 weeks). Dietary adherence is measured by two weekly 24-hour dietary recalls, a 4-day food record during the week prior to each visit, and both plasma and urine levels of trimethylamine- N -oxide at each visit. This study is the first to comprehensively assess multiple indices of inflammation and glucometabolic profile in a rigorously conducted randomized trial of patients with CAD on a vegan versus AHA-recommended diet.

  17. A multi-modal intervention for Activating Patients at Risk for Osteoporosis (APROPOS: Rationale, design, and uptake of online study intervention material

    Directory of Open Access Journals (Sweden)

    Maria I. Danila

    2016-12-01

    Conclusion: We developed and implemented a novel tailored multi-modal intervention to improve initiation of osteoporosis therapy. An email address provided on the survey was the most important factor independently associated with accessing the intervention online. The design and uptake of this intervention may have implications for future studies in osteoporosis or other chronic diseases.

  18. Determinants of cardiovascular disease and other non-communicable diseases in Central and Eastern Europe: Rationale and design of the HAPIEE study

    Directory of Open Access Journals (Sweden)

    Pikhart Hynek

    2006-10-01

    Full Text Available Abstract Background Over the last five decades, a wide gap in mortality opened between western and eastern Europe; this gap increased further after the dramatic fluctuations in mortality in the former Soviet Union (FSU in the 1990s. Recent rapid increases in mortality among lower socioeconomic groups in eastern Europe suggests that socioeconomic factors are powerful determinants of mortality in these populations but the more proximal factors linking the social conditions with health remain unclear. The HAPIEE (Health, Alcohol and Psychosocial factors In Eastern Europe study is a prospective cohort study designed to investigate the effect of classical and non-conventional risk factors and social and psychosocial factors on cardiovascular and other non-communicable diseases in eastern Europe and the FSU. The main hypotheses of the HAPIEE study relate to the role of alcohol, nutrition and psychosocial factors. Methods and design The HAPIEE study comprises four cohorts in Russia, Poland, the Czech Republic and Lithuania; each consists of a random sample of men and women aged 45–69 years old at baseline, stratified by gender and 5 year age groups, and selected from population registers. The total planned sample size is 36,500 individuals. Baseline information from the Czech Republic, Russia and Poland was collected in 2002–2005 and includes data on health, lifestyle, diet (food frequency, socioeconomic circumstances and psychosocial factors. A short examination included measurement of anthropometric parameters, blood pressure, lung function and cognitive function, and a fasting venous blood sample. Re-examination of the cohorts in 2006–2008 focuses on healthy ageing and economic well-being using face-to-face computer assisted personal interviews. Recruitment of the Lithuanian cohort is ongoing, with baseline and re-examination data being collected simultaneously. All cohorts are being followed up for mortality and non-fatal cardiovascular

  19. Early detection and integrated care for adolescents and young adults with severe psychotic disorders: rationales and design of the Integrated Care in Early Psychosis Study (ACCESS III).

    Science.gov (United States)

    Lambert, Martin; Schöttle, Daniel; Sengutta, Mary; Ruppelt, Friederike; Rohenkohl, Anja; Luedecke, Daniel; Nawara, Luise Antonia; Galling, Britta; Falk, Anne-Lena; Wittmann, Linus; Niehaus, Vivien; Sarikaya, Gizem; Handwerk, Ute; Rothländer, Wiebke; Rietschel, Liz; Gagern, Charlotte; Lange, Benjamin; Meigel-Schleiff, Christina; Naber, Dieter; Schulte-Markwort, Michael; Krüger, Helmut; Unger, Hans-Peter; Sippel, Sven; Ott, Sabine; Romer, Georg; Daubmann, Anne; Wegscheider, Karl; Correll, Christoph U; Schimmelmann, Benno G; Bock, Thomas; Gallinat, Jürgen; Karow, Anne

    2018-02-01

    The Integrated Care in Early Psychosis (ACCESS III) Study examined the efficacy and cost-effectiveness of a combined intervention consisting of strategies to improve early detection and quality of care (integrated care including therapeutic assertive community treatment) in adolescents and young adults in the early phase of a severe psychotic disorder from 2011 to 2014. This is a prospective, single-centre, 1-year cohort study comparing an intervention condition (early detection plus integrated care, n = 120) to the historical control condition (standard care, SC, n = 105) for adolescents and young adults aged 12-29 years suffering from a severe, early-phase psychotic disorder (i.e. within 2 years of treatment). Primary outcome is the rate of combined symptomatic (i.e. Positive and Negative Syndrome Scale (PANSS) criteria) and functional (i.e. Global Assessment of Functioning scale (GAF) ≥ 60 points criterion) remission over at least 6 months at study endpoint. Secondary outcome comprises the comparison of the reduction in the duration of untreated psychosis within the 4-year study duration between integrated care and SC, course of psychopathology, functioning, quality of life, satisfaction with care, cost and quality-adjusted life years (QALYs) in comparison to a historical control group. To the authors' knowledge, this is the first study assessing the efficacy and cost-effectiveness of a combined intervention consisting of early detection strategies and strategies to improve quality of care in both adolescents and young adults with early-phase psychosis. The results will be published in 2016. © 2016 John Wiley & Sons Australia, Ltd.

  20. Cardiovascular RiskprofilE - IMaging and gender-specific disOrders (CREw-IMAGO): rationale and design of a multicenter cohort study.

    Science.gov (United States)

    Zoet, Gerbrand A; Meun, Cindy; Benschop, Laura; Boersma, Eric; Budde, Ricardo P J; Fauser, Bart C J M; de Groot, Christianne J M; van der Lugt, Aad; Maas, Angela H E M; Moons, Karl G M; Roeters van Lennep, Jeanine E; Roos-Hesselink, Jolien W; Steegers, Eric A P; van Rijn, Bas B; Laven, Joop S E; Franx, Arie; Velthuis, Birgitta K

    2017-08-07

    Reproductive disorders, such as polycystic ovary syndrome (PCOS), primary ovarian insufficiency (POI) and hypertensive pregnancy disorders (HPD) like pre-eclampsia (PE), are associated with an increased risk of cardiovascular disease (CVD). Detection of early signs of cardiovascular disease (CVD), as well as identification of risk factors among women of reproductive age which improve cardiovascular risk prediction, is a challenge and current models might underestimate long-term health risks. The aim of this study is to assess cardiovascular disease in patients with a history of a reproductive disorder by low-dose computed tomography (CT). Women of 45 - 55 years, who experienced a reproductive disorder (PCOS, POI, HPD), are invited to participate in this multicenter, prospective, cohort study. Women will be recruited after regular cardiovascular screening, including assessment of classical cardiovascular risk factors. CT of the coronary arteries (both coronary artery calcium scoring (CACS), and contrast-enhanced coronary CT angiography (CCTA)) and carotid siphon calcium scoring (CSC) is planned in 300 women with HPD and 300 women with PCOS or POI. In addition, arterial stiffness (non-invasive pulse wave velocity (PWV)) measurement and cell-based biomarkers (inflammatory circulating cells) will be obtained. Initial inclusion is focused on women of 45 - 55 years. However, the age range (40 - 45 years and/or ≥ 55 years) and group composition may be adjusted based on the findings of the interim analysis. Participants can potentially benefit from information obtained in this study concerning their current cardiovascular health and expected future risk of cardiovascular events. The results of this study will provide insights in the development of CVD in women with a history of reproductive disorders. Ultimately, this study may lead to improved cardiovascular prediction models and will provide an opportunity for timely adjustment of preventive

  1. Cluster-randomised controlled trials of individual and combined water, sanitation, hygiene and nutritional interventions in rural Bangladesh and Kenya: the WASH Benefits study design and rationale

    Science.gov (United States)

    Arnold, Benjamin F; Null, Clair; Luby, Stephen P; Unicomb, Leanne; Stewart, Christine P; Dewey, Kathryn G; Ahmed, Tahmeed; Ashraf, Sania; Christensen, Garret; Clasen, Thomas; Dentz, Holly N; Fernald, Lia C H; Haque, Rashidul; Hubbard, Alan E; Kariger, Patricia; Leontsini, Elli; Lin, Audrie; Njenga, Sammy M; Pickering, Amy J; Ram, Pavani K; Tofail, Fahmida; Winch, Peter J; Colford, John M

    2013-01-01

    Introduction Enteric infections are common during the first years of life in low-income countries and contribute to growth faltering with long-term impairment of health and development. Water quality, sanitation, handwashing and nutritional interventions can independently reduce enteric infections and growth faltering. There is little evidence that directly compares the effects of these individual and combined interventions on diarrhoea and growth when delivered to infants and young children. The objective of the WASH Benefits study is to help fill this knowledge gap. Methods and analysis WASH Benefits includes two cluster-randomised trials to assess improvements in water quality, sanitation, handwashing and child nutrition—alone and in combination—to rural households with pregnant women in Kenya and Bangladesh. Geographically matched clusters (groups of household compounds in Bangladesh and villages in Kenya) will be randomised to one of six intervention arms or control. Intervention arms include water quality, sanitation, handwashing, nutrition, combined water+sanitation+handwashing (WSH) and WSH+nutrition. The studies will enrol newborn children (N=5760 in Bangladesh and N=8000 in Kenya) and measure outcomes at 12 and 24 months after intervention delivery. Primary outcomes include child length-for-age Z-scores and caregiver-reported diarrhoea. Secondary outcomes include stunting prevalence, markers of environmental enteropathy and child development scores (verbal, motor and personal/social). We will estimate unadjusted and adjusted intention-to-treat effects using semiparametric estimators and permutation tests. Ethics and dissemination Study protocols have been reviewed and approved by human subjects review boards at the University of California, Berkeley, Stanford University, the International Centre for Diarrheal Disease Research, Bangladesh, the Kenya Medical Research Institute, and Innovations for Poverty Action. Independent data safety monitoring

  2. A study on job satisfaction among clinical and non-clinical hospital ...

    African Journals Online (AJOL)

    Methods: Two hundred clinical and non-clinical hospital staff were invited to take part in the study. They completed a sociodemographic questionnaire and the Job Descriptive Index (JDI). Results: The results indicated that majority clinical and non-clinical staff were satisfied with their jobs as regards the parameters of the ...

  3. ASPIRE In-Home: rationale, design, and methods of a study to evaluate the safety and efficacy of automatic insulin suspension for nocturnal hypoglycemia.

    Science.gov (United States)

    Klonoff, David C; Bergenstal, Richard M; Garg, Satish K; Bode, Bruce W; Meredith, Melissa; Slover, Robert H; Ahmann, Andrew; Welsh, John B; Lee, Scott W

    2013-07-01

    Nocturnal hypoglycemia is a barrier to therapy intensification efforts in diabetes. The Paradigm® Veo™ system may mitigate nocturnal hypoglycemia by automatically suspending insulin when a prespecified sensor glucose threshold is reached. ASPIRE (Automation to Simulate Pancreatic Insulin REsponse) In-Home (NCT01497938) was a multicenter, randomized, parallel, adaptive study of subjects with type 1 diabetes. The control arm used sensor-augmented pump therapy. The treatment arm used sensor-augmented pump therapy with threshold suspend, which automatically suspends the insulin pump in response to a sensor glucose value at or below a prespecified threshold. To be randomized, subjects had to have demonstrated ≥2 episodes of nocturnal hypoglycemia, defined as >20 consecutive minutes of sensor glucose values ≤65 mg/dl starting between 10:00 PM and 8:00 AM in the 2-week run-in phase. The 3-month study phase evaluated safety by comparing changes in glycated hemoglobin (A1C) values and evaluated efficacy by comparing the mean area under the glucose concentration time curves for nocturnal hypoglycemia events in the two groups. Other outcomes included the rate of nocturnal hypoglycemia events and the distribution of sensor glucose values. Data from the ASPIRE In-Home study should provide evidence on the safety of the threshold suspend feature with respect to A1C and its efficacy with respect to severity and duration of nocturnal hypoglycemia when used at home over a 3-month period. © 2013 Diabetes Technology Society.

  4. Task shifting of frontline community health workers for cardiovascular risk reduction: design and rationale of a cluster randomised controlled trial (DISHA study) in India.

    Science.gov (United States)

    Jeemon, Panniyammakal; Narayanan, Gitanjali; Kondal, Dimple; Kahol, Kashvi; Bharadwaj, Ashok; Purty, Anil; Negi, Prakash; Ladhani, Sulaiman; Sanghvi, Jyoti; Singh, Kuldeep; Kapoor, Deksha; Sobti, Nidhi; Lall, Dorothy; Manimunda, Sathyaprakash; Dwivedi, Supriya; Toteja, Gurudyal; Prabhakaran, Dorairaj

    2016-03-15

    Effective task-shifting interventions targeted at reducing the global cardiovascular disease (CVD) epidemic in low and middle-income countries (LMICs) are urgently needed. DISHA is a cluster randomised controlled trial conducted across 10 sites (5 in phase 1 and 5 in phase 2) in India in 120 clusters. At each site, 12 clusters were randomly selected from a district. A cluster is defined as a small village with 250-300 households and well defined geographical boundaries. They were then randomly allocated to intervention and control clusters in a 1:1 allocation sequence. If any of the intervention and control clusters were workers (mainly Anganwadi workers and ASHA workers) and a post intervention survey in a representative sample. The study staff had no information on intervention allocation until the completion of the baseline survey. In order to ensure comparability of data across sites, the DISHA study follows a common protocol and manual of operation with standardized measurement techniques. Our study is the largest community based cluster randomised trial in low and middle-income country settings designed to test the effectiveness of 'task shifting' interventions involving frontline health workers for cardiovascular risk reduction. CTRI/2013/10/004049 . Registered 7 October 2013.

  5. Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism. Rationale for and design of the EINSTEIN CHOICE study.

    Science.gov (United States)

    Weitz, Jeffrey I; Bauersachs, Rupert; Beyer-Westendorf, Jan; Bounameaux, Henri; Brighton, Timothy A; Cohen, Alexander T; Davidson, Bruce L; Holberg, Gerlind; Kakkar, Ajay; Lensing, Anthonie W A; Prins, Martin; Haskell, Lloyd; van Bellen, Bonno; Verhamme, Peter; Wells, Philip S; Prandoni, Paolo

    2015-08-31

    Patients with unprovoked venous thromboembolism (VTE) are at high risk for recurrence. Although rivaroxaban is effective for extended VTE treatment at a dose of 20 mg once daily, use of the 10 mg dose may further improve its benefit-to-risk ratio. Low-dose aspirin also reduces rates of recurrent VTE, but has not been compared with anticoagulant therapy. The EINSTEIN CHOICE study is a multicentre, randomised, double-blind, active-controlled, event-driven study comparing the efficacy and safety of two once daily doses of rivaroxaban (20 and 10 mg) with aspirin (100 mg daily) for the prevention of recurrent VTE in patients who completed 6-12 months of anticoagulant therapy for their index acute VTE event. All treatments will be given for 12 months. The primary efficacy objective is to determine whether both doses of rivaroxaban are superior to aspirin for the prevention of symptomatic recurrent VTE, while the principal safety outcome is the incidence of major bleeding. The trial is anticipated to enrol 2,850 patients from 230 sites in 31 countries over a period of 27 months. In conclusion, the EINSTEIN CHOICE study will provide new insights into the optimal antithrombotic strategy for extended VTE treatment by comparing two doses of rivaroxaban with aspirin (clinicaltrials.gov NCT02064439).

  6. When clinical trials compete: prioritising study recruitment.

    Science.gov (United States)

    Gelinas, Luke; Lynch, Holly Fernandez; Bierer, Barbara E; Cohen, I Glenn

    2017-12-01

    It is not uncommon for multiple clinical trials at the same institution to recruit concurrently from the same patient population. When the relevant pool of patients is limited, as it often is, trials essentially compete for participants. There is evidence that such a competition is a predictor of low study accrual, with increased competition tied to increased recruitment shortfalls. But there is no consensus on what steps, if any, institutions should take to approach this issue. In this article, we argue that an institutional policy that prioritises some trials for recruitment ahead of others is ethically permissible and indeed prima facie preferable to alternative means of addressing recruitment competition. We motivate this view by appeal to the ethical importance of minimising the number of studies that begin but do not complete, thereby exposing their participants to unnecessary risks and burdens in the process. We then argue that a policy of prioritisation can be fair to relevant stakeholders, including participants, investigators and funders. Finally, by way of encouraging and helping to frame future debate, we propose some questions that would need to be addressed when identifying substantive ethical criteria for prioritising between studies. 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/.

  7. Clinical application of cerebral dynamic perfusion studies

    International Nuclear Information System (INIS)

    DeLand, F.H.

    1975-01-01

    Radionuclide cerebral perfusion studies are assuming a far greater importance in the detection and differential diagnosis of cerebral lesions. Perfusion studies not only contribute to the differential diagnosis of lesions but in certain cases are the preferred methods by which more accurate clinical interpretations can be made. The characteristic blood flow of arterio-venous malformations readily differentiates this lesion from neoplasms. The decreased perfusion or absent perfusion observed in cerebral infarctions is diagnostic without concurrent evidence from static images. Changes in rates and direction of blood flow contribute fundamental information to the status of stenosis and vascular occlusion and, in addition, offer valuable information on the competency and routes of collateral circulation. The degree of cerebral perfusion after cerebral vascular accidents appears to be directly related to patient recovery, particularly muscular function. Cerebral perfusion adds a new parameter in the diagnosis of subdural haematomas and concussion and in the differentiation of obscuring radioactivity from superficial trauma. Although pictorial displays of perfusion blood flow will offer information in most cerebral vascular problems, the addition of computer analysis better defines temporal relationships of regional blood flow, quantitative changes in flow and the detection of the more subtle increases or decreases in cerebral blood flow. The status of radionuclide cerebral perfusion studies has taken on an importance making it the primary modality for the diagnosis of cerebral lesions. (author)

  8. A cluster-randomized, controlled trial of nutritional supplementation and promotion of responsive parenting in Madagascar: the MAHAY study design and rationale.

    Science.gov (United States)

    Fernald, Lia C H; Galasso, Emanuela; Qamruddin, Jumana; Ranaivoson, Christian; Ratsifandrihamanana, Lisy; Stewart, Christine P; Weber, Ann M

    2016-06-03

    Over half of the world's children suffer from poor nutrition, and as a consequence they experience delays in physical and mental health, and cognitive development. There is little data evaluating the effects of delivery of lipid-based, nutrition supplementation on growth and development during pregnancy and early childhood within the context of a scaled-up program. Furthermore, there is limited evidence on effects of scaled-up, home-visiting programs that focus on the promotion of child development within the context of an existing, national nutrition program. The MAHAY ("smart" in Malagasy) study uses a multi-arm randomized-controlled trial (RCT) to test the effects and cost-effectiveness of combined interventions to address chronic malnutrition and poor child development. The arms of the trial are: (T0) existing program with monthly growth monitoring and nutritional/hygiene education; (T1) is T0 + home visits for intensive nutrition counseling within a behavior change framework; (T2) is T1 + lipid-based supplementation (LNS) for children 6-18 months old; (T3) is T2 + LNS supplementation of pregnant/lactating women; and (T4) is T1 + intensive home visiting program to support child development. There are anticipated to be n = 25 communities in each arm (n = 1250 pregnant women, n = 1250 children 0-6 months old, and n = 1250 children 6-18 months old). Primary outcomes include growth (length/height-for-age z-scores) and child development (mental, motor and social development). Secondary outcomes include care-giver reported child morbidity, household food security and diet diversity, micro-nutrient status, maternal knowledge of child care and feeding practices, and home stimulation practices. We will estimate unadjusted and adjusted intention-to-treat effects. Study protocols have been reviewed and approved by the Malagasy Ethics Committee at the Ministry of Health in Madagascar and by the institutional review board at the University of

  9. A cluster-randomized, controlled trial of nutritional supplementation and promotion of responsive parenting in Madagascar: the MAHAY study design and rationale

    Directory of Open Access Journals (Sweden)

    Lia C. H. Fernald

    2016-06-01

    Full Text Available Abstract Background Over half of the world’s children suffer from poor nutrition, and as a consequence they experience delays in physical and mental health, and cognitive development. There is little data evaluating the effects of delivery of lipid-based, nutrition supplementation on growth and development during pregnancy and early childhood within the context of a scaled-up program. Furthermore, there is limited evidence on effects of scaled-up, home-visiting programs that focus on the promotion of child development within the context of an existing, national nutrition program. Methods/Design The MAHAY ("smart" in Malagasy study uses a multi-arm randomized-controlled trial (RCT to test the effects and cost-effectiveness of combined interventions to address chronic malnutrition and poor child development. The arms of the trial are: (T0 existing program with monthly growth monitoring and nutritional/hygiene education; (T1 is T0 + home visits for intensive nutrition counseling within a behavior change framework; (T2 is T1 + lipid-based supplementation (LNS for children 6–18 months old; (T3 is T2 + LNS supplementation of pregnant/lactating women; and (T4 is T1 + intensive home visiting program to support child development. There are anticipated to be n = 25 communities in each arm (n = 1250 pregnant women, n = 1250 children 0–6 months old, and n = 1250 children 6–18 months old. Primary outcomes include growth (length/height-for-age z-scores and child development (mental, motor and social development. Secondary outcomes include care-giver reported child morbidity, household food security and diet diversity, micro-nutrient status, maternal knowledge of child care and feeding practices, and home stimulation practices. We will estimate unadjusted and adjusted intention-to-treat effects. Study protocols have been reviewed and approved by the Malagasy Ethics Committee at the Ministry of Health in Madagascar and by

  10. Rationale and design of the Karolinska-Rennes (KaRen) prospective study of dyssynchrony in heart failure with preserved ejection fraction.

    Science.gov (United States)

    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.

  11. The MATCH cohort study in the Netherlands: rationale, objectives, methods and baseline characteristics of patients with (long-term) common mental disorders.

    Science.gov (United States)

    Koekkoek, Bauke; Manders, Willeke; Tendolkar, Indira; Hutschemaekers, Giel; Tiemens, Bea

    2017-03-01

    Research in the last decades shows that common mental disorders may be long-term and severely disabling, resulting in severe mental illness (SMI). The percentage of Dutch SMI-patients with common mental disorders receiving mental health services is estimated at 65-70%. However, it is unclear which patients in fact become SMI-patients. We need to know more about the possible course of common mental disorders, understand the origins of chronicity in more detail, and have more insight in related care processes and care use of patients with common mental disorders. The MATCH cohort study is a four-year multicentre naturalistic cohort study, with yearly assessments in primary, secondary, and tertiary services in three large Dutch mental health services. Socio-demographics, mental disorders, course and severity of psychopathology, physiological health indicators, neurocognitive functioning, past and present life events, health care use and contact with mental health services, social functioning and quality of life, and recovery and well-being are assessed. Baseline findings of 283 participating individuals and their key clinicians are described. The sample appears to appropriately represent the distribution of individuals across diagnostic categories in services, and level of care (outpatient, day treatment, inpatient) in the Netherlands and other developed nations. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  12. Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery.

    Science.gov (United States)

    Hemmes, Sabrine N T; Severgnini, Paolo; Jaber, Samir; Canet, Jaume; Wrigge, Hermann; Hiesmayr, Michael; Tschernko, Edda M; Hollmann, Markus W; Binnekade, Jan M; Hedenstierna, Göran; Putensen, Christian; de Abreu, Marcelo Gama; Pelosi, Paolo; Schultz, Marcus J

    2011-05-06

    Post-operative pulmonary complications add to the morbidity and mortality of surgical patients, in particular after general anesthesia >2 hours for abdominal surgery. Whether a protective mechanical ventilation strategy with higher levels of positive end-expiratory pressure (PEEP) and repeated recruitment maneuvers; the "open lung strategy", protects against post-operative pulmonary complications is uncertain. The present study aims at comparing a protective mechanical ventilation strategy with a conventional mechanical ventilation strategy during general anesthesia for abdominal non-laparoscopic surgery. The PROtective Ventilation using HIgh versus LOw positive end-expiratory pressure ("PROVHILO") trial is a worldwide investigator-initiated multicenter randomized controlled two-arm study. Nine hundred patients scheduled for non-laparoscopic abdominal surgery at high or intermediate risk for post-operative pulmonary complications are randomized to mechanical ventilation with the level of PEEP at 12 cmH(2)O with recruitment maneuvers (the lung-protective strategy) or mechanical ventilation with the level of PEEP at maximum 2 cmH(2)O without recruitment maneuvers (the conventional strategy). The primary endpoint is any post-operative pulmonary complication. The PROVHILO trial is the first randomized controlled trial powered to investigate whether an open lung mechanical ventilation strategy in short-term mechanical ventilation prevents against postoperative pulmonary complications. ISRCTN: ISRCTN70332574.

  13. The FIND-CKD study--a randomized controlled trial of intravenous iron versus oral iron in non-dialysis chronic kidney disease patients: background and rationale.

    Science.gov (United States)

    Macdougall, Iain C; Bock, Andreas; Carrera, Fernando; Eckardt, Kai-Uwe; Gaillard, Carlo; Van Wyck, David; Roubert, Bernard; Cushway, Timothy; Roger, Simon D

    2014-04-01

    Rigorous data are sparse concerning the optimal route of administration and dosing strategy for iron therapy with or without concomitant erythropoiesis-stimulating agent (ESA) therapy for the management of iron deficiency anaemia in patients with non-dialysis dependent chronic kidney disease (ND-CKD). FIND-CKD was a 56-week, open-label, multicentre, prospective, randomized three-arm study (NCT00994318) of 626 patients with ND-CKD and iron deficiency anaemia randomized to (i) intravenous (IV) ferric carboxymaltose (FCM) at an initial dose of 1000 mg iron with subsequent dosing as necessary to target a serum ferritin level of 400-600 µg/L (ii) IV FCM at an initial dose of 200 mg with subsequent dosing as necessary to target serum ferritin 100-200 µg/L or (iii) oral ferrous sulphate 200 mg iron/day. The primary end point was time to initiation of other anaemia management (ESA therapy, iron therapy other than study drug or blood transfusion) or a haemoglobin (Hb) trigger (two consecutive Hb values FIND-CKD was the longest randomized trial of IV iron therapy to date. Its findings will address several unanswered questions regarding iron therapy to treat iron deficiency anaemia in patients with ND-CKD. It was also the first randomized trial to utilize both a high and low serum ferritin target range to adjust IV iron dosing, and the first not to employ Hb response as its primary end point.

  14. eEduHeart I: A Multicenter, Randomized, Controlled Trial Investigating the Effectiveness of a Cardiac Web-Based eLearning Platform - Rationale and Study Design.

    Science.gov (United States)

    Frederix, Ines; Vandenberk, Thijs; Janssen, Leen; Geurden, Anne; Vandervoort, Pieter; Dendale, Paul

    Cardiac telerehabilitation includes, in its most comprehensive format, telemonitoring, telecoaching, social interaction, and eLearning. The specific role of eLearning, however, was seldom assessed. The aim of eEduHeart I is to investigate the medium-term effectiveness of the addition of a cardiac web-based eLearing platform to conventional cardiac care. In this prospective, multicenter randomized, controlled trial, 1,000 patients with coronary artery disease will be randomized 1:1 to an intervention group (receiving 1-month unrestricted access to the cardiac eLearning platform in addition to conventional cardiac care) or to conventional cardiac care alone. The primary endpoint is health-related quality of life, assessed by the HeartQoL questionnaire at the 1- and 3-month follow-ups. Secondary endpoints include pathology-specific knowledge and self-reported eLearning platform user experience. Data on the eLearning platform usage will be gathered through web logging during the study period. eEduHeart I will be one of the first studies to report on the added value of eLearning. If the intervention is proven effective, current cardiac telerehabilitation programs can be augmented by including eLearning, too. The platform can then be used as a model for other chronic diseases in which patient education plays a key role. © 2016 S. Karger AG, Basel.

  15. Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery

    Directory of Open Access Journals (Sweden)

    Hedenstierna Göran

    2011-05-01

    Full Text Available Abstract Background Post-operative pulmonary complications add to the morbidity and mortality of surgical patients, in particular after general anesthesia >2 hours for abdominal surgery. Whether a protective mechanical ventilation strategy with higher levels of positive end-expiratory pressure (PEEP and repeated recruitment maneuvers; the "open lung strategy", protects against post-operative pulmonary complications is uncertain. The present study aims at comparing a protective mechanical ventilation strategy with a conventional mechanical ventilation strategy during general anesthesia for abdominal non-laparoscopic surgery. Methods The PROtective Ventilation using HIgh versus LOw positive end-expiratory pressure ("PROVHILO" trial is a worldwide investigator-initiated multicenter randomized controlled two-arm study. Nine hundred patients scheduled for non-laparoscopic abdominal surgery at high or intermediate risk for post-operative pulmonary complications are randomized to mechanical ventilation with the level of PEEP at 12 cmH2O with recruitment maneuvers (the lung-protective strategy or mechanical ventilation with the level of PEEP at maximum 2 cmH2O without recruitment maneuvers (the conventional strategy. The primary endpoint is any post-operative pulmonary complication. Discussion The PROVHILO trial is the first randomized controlled trial powered to investigate whether an open lung mechanical ventilation strategy in short-term mechanical ventilation prevents against postoperative pulmonary complications. Trial registration ISRCTN: ISRCTN70332574

  16. Statistical Issues in TBI Clinical Studies

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    Paul eRapp

    2013-11-01

    Full Text Available The identification and longitudinal assessment of traumatic brain injury presents several challenges. Because these injuries can have subtle effects, efforts to find quantitative physiological measures that can be used to characterize traumatic brain injury are receiving increased attention. The results of this research must be considered with care. Six reasons for cautious assessment are outlined in this paper. None of the issues raised here are new. They are standard elements in the technical literature that describes the mathematical analysis of clinical data. The purpose of this paper is to draw attention to these issues because they need to be considered when clinicians evaluate the usefulness of this research. In some instances these points are demonstrated by simulation studies of diagnostic processes. We take as an additional objective the explicit presentation of the mathematical methods used to reach these conclusions. This material is in the appendices. The following points are made:1. A statistically significant separation of a clinical population from a control population does not ensure a successful diagnostic procedure.2. Adding more variables to a diagnostic discrimination can, in some instances, actually reduce classification accuracy.3. A high sensitivity and specificity in a TBI versus control population classification does not ensure diagnostic successes when the method is applied in a more general neuropsychiatric population. 4. Evaluation of treatment effectiveness must recognize that high variability is a pronounced characteristic of an injured central nervous system and that results can be confounded by either disease progression or spontaneous recovery. A large pre-treatment versus post-treatment effect size does not, of itself, establish a successful treatment.5. A procedure for discriminating between treatment responders and nonresponders requires, minimally, a two phase investigation. This procedure must include a

  17. Hypothyroid myopathy. A clinical and pathologaical study.

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    McKeran, R O; Slavin, G; Ward, P; Paul, E; Mair, W G

    1980-09-01

    Ten patients with varying degrees of hypothroid myopathy were studied clinically and by serial percutaneous needle muscle biopsies before and during treatment with L-thyroxine. The biochemical evidence of hypothyroidism was related to the severity of the myopathic and signs before treatment. The severity of myopathic symptoms before and during treatment correlated with the biochemical evidence of hypothyrodism, a type II fibre atrophy and increased central nuclear counts. Likewise, the clinical evidence of a myopathy before and during treatment was correlated with both a type II fibre atrophy and loss and increased central nuclear counts but was not related to the biochemical parameters of hypothyroidism, except the level of thyroid stimulating hormone. In the muscle, before and during treatment, of the two most severely affected patients, intracellular glycogen inclusions were seen in scattered muscle fibres. On light microscopy and on electronmicroscopy, numerous mitochondria were seen responding to L-thyroxine with accumulations of subsarcolemmal honey-combing. Vesicular abnormalities, an electron dense matrix or occasional crystalline deposits were seen in muscle mitochondria from less severely azffected patients. Severely myopathic muscle contained excessive glycogen, membrane bound glycogen and excess lipid in a mainly perinuclear distribution. Occasional myelin and membranous bodies were seen and satellite cells during the recovery phase. A group of patients with hypothyroid myopathy who are likely to have a delayed recovery of full muscle strength on L-thyroxine may be recognised by the presence of severe proximal muscle weakness and characteristic changes on histochemical and electronmicroscopic examination of muscle. The spectrum of histochemical and electronmicroscopic abnormalities of muscle revealed with increasing degree of hypothyrodism, suggests that a generally reversible acquired glycogen storage and mictochondrial disorder is an important feature

  18. Establishing a birth cohort to investigate the course and aetiology of asthma and allergies across three generations - rationale, design, and methods of the ACROSSOLAR study.

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    Weinmann, Tobias; Gerlich, Jessica; Heinrich, Sabine; Nowak, Dennis; Gerdes, Jennifer; Schlichtiger, Jenny; von Mutius, Erika; Schaub, Bianca; Vogelberg, Christian; Roller, Diana; Radon, Katja

    2015-12-04

    Atopic diseases are a major burden of disease on a global scale. Regarding their aetiology, the early years of life are assumed to play a crucial role. In addition, there is growing evidence that elucidating the impact of cross-generational effects and epigenetic mechanisms such as DNA methylation can substantially widen the scientific knowledge of the occurrence and progression of these diseases. We are thus aiming at following the course of asthma, allergies, and potential risk factors for their occurrence across three generations by establishing a birth cohort in the offspring of an existing population-based cohort. 2051 young adults who have been recruited in 1995 for Phase II of the International Study of Asthma and Allergies in Childhood (ISAAC) and who have subsequently been followed-up by the Study on Occupational Allergy Risks (SOLAR) are asked bi-annually since 2009 if they conceived a child in the meantime. If parenthood is reported, parents are invited to enrol along with their children in the ACROSSOLAR cohort. Participation involves completing a questionnaire assessing general and health-related information about the course of the pregnancy and the first year of life of their children. Subsequently, the children are followed up until primary school age when asthma and allergies can be diagnosed reliably. In addition, DNA for epigenetic analysis will be collected and analysed. Longitudinal data analysis techniques will then be used to assess potential associations between early-life exposures and onset of childhood asthma and allergies taking into account epigenetics. Birth cohorts are especially suited to elucidate the impact of genetic predisposition, epigenetics, exposures during the first years of life, and gene-environment interactions on the occurrence and progression of asthma and allergies. By building upon an existing cohort, ACROSSOLAR offers a unique and cost-effective opportunity to investigate the aetiology of atopic disease in a

  19. CLINICAL STUDY OF POST LAPAROTOMY WOUND DEHISCENCE

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    Chanda Ramanachalam

    2017-04-01

    Full Text Available BACKGROUND The aim of the study is to- 1. Assess the association and prevalence of risk factors involved in causing post laparotomy wound dehiscence. 2. Identify the type of disease involved in causing abdominal wound dehiscence. 3. Effectively manage cases of wound dehiscence. MATERIALS AND METHODS Total 50 cases clinically presenting as gaping of abdominal wound and discharge from the site during the period of October 2014 to April 2016 were taken for study. Patients presenting with abdominal wound dehiscence after undergoing elective or emergency operation Each case was examined clinically and properly in systematic manner and an elaborative study of history based on chief complaints, significant risk factors, investigations, time and type of surgery performed and postoperative events and day of onset of wound dehiscence. RESULTS Males outnumbered females with 64% males and 36% females. Patients in the age group of 41-50 years and 51-60 years found to have highest incidence of abdominal wound dehiscence. Mean age of the patients affected was 48.02 years. Incidence of abdominal wound dehiscence is more common in patients with peritonitis due to duodenal and appendicular perforation than in case of intestinal obstruction. Incidence of abdominal wound dehiscence is more common in patients who are operated in emergency than elective (35:15. Surgical procedures, which included perforation closure carried higher incidence of wound dehiscence. Patients operated with midline incision carried higher risk for wound dehiscence than those operated with paramedian incisions. Incidence of abdominal wound dehiscence is more common in patients having their BMI >25 and anaemia (Hb% <10 g%. Average stay was 22 days, which increased both economic burden on patient and hospital. Out of 50 cases, 48 survivals and 2 were mortals. Partial wound dehiscence was conservative management, i.e. healing by secondary intention was observed in 32 patients and 8 patients had

  20. CLINICAL STUDY OF EARLY BREAST CARCINOMA

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    Kiran Kumar

    2016-01-01

    Full Text Available Carcinoma of the breast is one of the commonest cancers occurring in female and accounts for 1/3rd of all the malignant diseases occurring in them. It is mainly a disease of the developed countries and accounts for 1,00,000 deaths annually. Breast carcinoma is classified as Early breast cancer, Locally advanced breast cancer and Metastatic breast cancer. By definition early stage breast cancer constitutes breast tumors of clinical stages I, IIa and T2N1M0. Early breast cancer is the one diagnosed by mammography. Women when approaches at this stage, they can go for breast conservation surgery. Not all women are candidates for this approach, and some require mastectomy as part of their treatment. AIM To observe the incidence of early breast carcinoma with particular reference to the time taken by the patients to seek medical advice after the symptoms have developed i.e. the average time taken by the patients to seek medical advice, their appropriate management and prognosis. MATERIALS AND METHODS This prospective study was conducted over a period of 2 years from Oct-2012 to Oct-2014 in 30 female patients aged between 25-65 years who were presented with lump in breast of size ≤5cms with or without pain, with or without lymph nodes to the outpatient department. All the patients were thoroughly asked about history, examined clinically, investigated, staged and managed by surgery either Breast Conservation Surgery or Modified Radical Mastectomy. Postoperative complications were recorded and followed up regularly. RESULTS The incidence of early breast cancer in this study was 0.98% with peak age incidence between 40-60 years and duration of symptoms <6 months in 18 patients. Breast Conservation Surgery + axillary dissection + Radiotherapy was done in 23%. Prognosis was good in these patients with no local recurrence and death. CONCLUSION The prognosis of early stage breast carcinoma patients in this study was good. To have long term tumor free and

  1. Rationale and design of the Miami Healthy Heart Initiative: a randomized controlled study of a community health worker intervention among Latino patients with poorly controlled diabetes

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    Carrasquillo O

    2014-02-01

    Full Text Available Olveen Carrasquillo,1,2 Elizabeth Patberg,1 Yisel Alonzo,1 Hua Li,2 Sonjia Kenya1 1Department of Medicine, 2Public Health Sciences, University of Miami, Miller School of Medicine, Miami, FL, USA Background: Type 2 diabetes mellitus disproportionately affects the Latino community. Latinos with diabetes are also less likely to have adequate control of cardiovascular risk factors such as cholesterol and blood pressure. Community health workers (CHWs are increasingly being used to address various health disparity conditions, including diabetes. However, evidence of their effectiveness from randomized controlled trials is limited. Methods: The Miami Health Heart Initiative is a randomized controlled trial of 300 Latino patients with diabetes. Patients with hemoglobin A1c (HbA1c ≥8.0% were recruited from Miami-Dade's public hospital system. At baseline, all patients underwent phlebotomy, physical examination, and a structured 90-minute research interview. They were then randomized to either usual care or a CHW intervention called Cariño. For participants in the Cariño arm of the study, CHW services included assistance with nonmedical social services, health education, and patient navigation in which the CHWs serve as a bridge between patients and the health care system. These services were delivered through home visits, phone calls, and group visits. At 12 months, all subjects had a follow-up examination. The primary outcomes at 1 year are changes in systolic blood pressure, low-density lipoprotein, and HbA1c. Secondary outcomes include medication adherence, medication intensification, diabetes self-efficacy, physical activity, and self-reported fruit and vegetable intake. Discussion: The Miami Healthy Heart Initiative is one of the first rigorously conducted randomized controlled trials to provide evidence on the impact of CHWs on diabetes intermediate outcomes among Latinos. If the data support our primary hypotheses, the study would lend added

  2. Do studies on cortical plasticity provide a rationale for using non invasive brain stimulation as a treatment for Parkinson’s disease patients?

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    Giacomo eKoch

    2013-11-01

    Full Text Available Animal models of Parkinson’s disease (PD have shown that key mechanisms of cortical plasticity such as long-term potentiation (LTP and long-term depression (LTD can be impaired by the PD pathology. In humans protocols of non-invasive brain stimulation, such as paired associative stimulation (PAS and theta burst stimulation (TBS, can be used to investigate cortical plasticity of the primary motor cortex. Through the amplitude of the motor evoked potential (MEP these transcranial magnetic stimulation methods allow to measure both LTP-like and LTD-like mechanisms of cortical plasticity. So far these protocols have reported some controversial findings when tested in PD patients. While various studies described evidence for reduced LTP- and LTD-like plasticity, others showed different results, demonstrating increased LTP-like and normal LTD-like plasticity. Recent evidence provided support to the hypothesis that these different patterns of cortical plasticity likely depend on the stage of the disease and on the concomitant administration of levo-dopa. However, it still unclear how and if these altered mechanisms of cortical plasticity can be taken as a reliable model to build appropriate protocols aimed at treating PD symptoms b

  3. Effect of serial infusions of reconstituted high-density lipoprotein (CER-001) on coronary atherosclerosis: rationale and design of the CARAT study.

    Science.gov (United States)

    Andrews, Jordan; Janssan, Alex; Nguyen, Tracy; Pisaniello, Anthony D; Scherer, Daniel J; Kastelein, John J P; Merkely, Bela; Nissen, Steven E; Ray, Kausik; Schwartz, Gregory G; Worthley, Stephen G; Keyserling, Connie; Dasseux, Jean-Louis; Butters, Julie; Girardi, Jacinta; Miller, Rosemary; Nicholls, Stephen J

    2017-02-01

    High-density lipoprotein (HDL) is believed to have atheroprotective properties, but an effective HDL-based therapy remains elusive. Early studies have suggested that infusion of reconstituted HDL promotes reverse cholesterol transport and vascular reactivity. The CER-001 Atherosclerosis Regression Acute Coronary Syndrome Trial (CARAT) is investigating the impact of infusing an engineered pre-beta HDL mimetic containing sphingomyelin (SM) and dipalmitoyl phosphatidlyglycerol (CER-001) on coronary atheroma volume in patients with a recent acute coronary syndrome (ACS). The CARAT is a phase 2, multicenter trial in which 292 patients with an ACS undergoing intracoronary ultrasonography and showing percent atheroma volume (PAV) greater than 30% are randomly assigned to treatment with ten infusions of CER-001 3 mg/kg or matching placebo, administered at weekly intervals. Intracoronary ultrasonography is repeated at the end of the treatment period. The primary endpoint is the nominal change in PAV. Safety and tolerability will also be evaluated. CARAT will establish whether serial 3 mg/kg infusions of an engineered pre-beta HDL mimetic containing SM and dipalmitoyl phosphatidlyglycerol (CER-001) will regress atherosclerotic plaque in patients with a recent ACS.

  4. Periodontal conditions in vegetarians: a clinical study.

    Science.gov (United States)

    Staufenbiel, I; Weinspach, K; Förster, G; Geurtsen, W; Günay, H

    2013-08-01

    Investigations about possible correlations between vegetarian diet and periodontal conditions are rare and characterized by small case numbers. The aim of this clinical study was to investigate the influence of a vegetarian diet on periodontal parameters with an appropriate sample size. A total of 200 patients, 100 vegetarians and 100 non-vegetarians, were included in the study. All patients were examined including a full mouth assessment of the periodontal and dental conditions. In addition, a questionnaire was handed out to ask for patients' oral hygiene habits and level of education. For statistical analysis the Mann-Whitney Test (χ(2) for analysis of the questionnaire) was applied (level of significance: Pvegetarians versus 41.72 years non-vegetarians). Vegetarians had significantly lower probing pocket depths (P=0.039), bleeding on probing (P=0.001), periodontal screening index (P=0.012), a better hygiene index (Pvegetarians. Furthermore, vegetarians had a higher level of education (PVegetarians revealed better periodontal conditions (less inflammation signs, less periodontal damage and a better dental home care). However, it should be considered that vegetarians are not only avoiding meat in their nutrition but are also characterized by an overall healthier life style.

  5. CLINICAL STUDY OF FISTULA IN ANO

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    Sushma Ramteke

    2017-02-01

    Full Text Available BACKGROUND Fistula in ano is one of the common problem faced in today’s world. Fistula in ano is track lined by granulation tissue that connect deeply in the anal canal or rectum and superficially on the skin around the anus. It usually results from cryptoglandular infection causing abscess, which burst spontaneously or was drained inadequately. The study is conducted to find most common aetiological factor and to evaluate various surgical technique and their outcome. The aim of the study is to- 1. Study the incidence of various aetiologies of fistula in ano. 2. Study the clinical presentation of fistula in ano. 3. Evaluate different modalities of surgical approach and their outcome. MATERIALS AND METHODS This prospective study was conducted at Late Lakhiram Agrawal Memorial Government Medical College, Raigarh, during the study period of July 2015 to July 2016. All the 50 cases were included in this study who were above 15 year of age diagnosed with fistula in ano on the basis of clinical examination who underwent surgical procedure. RESULTS In present study of 50 cases, 60% of cases were in the age group of 31-50 years. Male:female ratio was 9:1. 80% of cases belong to low socioeconomic status. The most common mode of presentation was discharging sinus in 96% of cases. 70% of patient had past history of burst abscess or surgical drainage of abscess. 90% of cases have single external opening. 80% of cases had posterior external opening. Most of the fistula are of low anal type, which was 92% and rest of the patient had an internal opening situated above the anorectal ring. The most common surgical approach done was fistulectomy. Only fistulectomy was done in 80% of patients. Fistulectomy with sphincterectomy was done in two patients. These two patients had associated anal fissure. Fistulectomy with seton placement was done in two patients of high level of fistula type. Fistulotomy was done in four patients (8%, these were of low fistula type

  6. Rationale and study design for a randomised controlled trial to reduce sedentary time in adults at risk of type 2 diabetes mellitus: project stand (Sedentary Time ANd diabetes

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    Wilmot Emma G

    2011-12-01

    Full Text Available Abstract Background The rising prevalence of Type 2 Diabetes Mellitus (T2DM is a major public health problem. There is an urgent need for effective lifestyle interventions to prevent the development of T2DM. Sedentary behaviour (sitting time has recently been identified as a risk factor for diabetes, often independent of the time spent in moderate-to-vigorous physical activity. Project STAND (Sedentary Time ANd Diabetes is a study which aims to reduce sedentary behaviour in younger adults at high risk of T2DM. Methods/Design A reduction in sedentary time is targeted using theory driven group structured education. The STAND programme is subject to piloting and process evaluation in line with the MRC framework for complex interventions. Participants are encouraged to self-monitor and self-regulate their behaviour. The intervention is being assessed in a randomised controlled trial with 12 month follow up. Inclusion criteria are a aged 18-40 years with a BMI in the obese range; b 18-40 years with a BMI in the overweight range plus an additional risk factor for T2DM. Participants are randomised to the intervention (n = 89 or control (n = 89 arm. The primary outcome is a reduction in sedentary behaviour at 12 months as measured by an accelerometer (count Conclusions This is the first UK trial to address sedentary behaviour change in a population of younger adults at risk of T2DM. The results will provide a platform for the development of a range of future multidisciplinary interventions in this rapidly expanding high-risk population. Trial registration Current controlled trials ISRCTN08434554, MRC project 91409.

  7. [Clinical studies on flomoxef in acute tonsillitis].

    Science.gov (United States)

    Tomiyama, M

    1994-09-01

    To objectively evaluate the clinical efficacy and safety in acute tonsillitis, flomoxef (FMOX) was examined for the distribution of sensitivity of clinical strains to it and for its clinical usefulness. 1. The 80% minimum inhibitory concentration of 11 clinical strains of Gram-positive bacteria, 6 of Gram-negative bacteria and 5 of anaerobic bacteria was 0.39 microgram/ml. FMOX showed the strongest, most comprehensive antibacterial action among the drugs tested. 2. Thirty patients received FMOX. Clinical effectiveness was evaluated in 28 patients, and clinical usefulness and safety in 30. 3. The clinical efficacy rate ('excellent' and 'good') was 75% (21/28). 4. As for bacteriological response, bacterial elimination rates were 67% for Gram-positive bacteria, 100% for Gram-negative bacteria, 100% for anaerobic bacteria and 100% for mixed infections. 5. Side effects occurred in 2 (6%) patients: drug eruption and diarrhea in 1 patient each. These symptoms improved rapidly after discontinuation of the drug. 6. Although abnormal clinical test results were found in 7 (23%) patients, i.e., increases in GOT and GPT in 2, in GPT in 4 and in BUN in 1, they were transient. 7. The usefulness of FMOX was assessed in light of its efficacy and safety. It was highly satisfactory in 14 patients, satisfactory in 11, relatively satisfactory in 1, unsatisfactory in 2 and highly unsatisfactory in 2, and rate of usefulness was 83%. FMOX is considered to be highly useful for the treatment of severe acute tonsillitis.

  8. A cluster randomised controlled trial of an intervention to promote healthy lifestyle habits to school leavers: study rationale, design, and methods.

    Science.gov (United States)

    Gillison, Fiona; Standage, Martyn; Verplanken, Bas

    2014-03-04

    Physical inactivity and a poor diet predict lifestyle diseases such as diabetes, cardiovascular disease, and certain types of cancer. Marked declines in physical activity occur during late adolescence, coinciding with the point at which many young people leave school and enter the workforce and begin to take greater control over their lifestyle behaviours. The work outlined within this paper sought to test a theoretically-informed intervention aimed at supporting increased engagement in physical activity and healthy eating habits in young people at the point of transition from school to work or work-based learning. As actively engaging young people in initiatives based on health messages is challenging, we also tested the efficacy of financial incentives in promoting initial engagement with the programme. A three-arm cluster-randomised design was used. Participants were school pupils from Year 11 and 13 (i.e., in their final year of study), aged 16-18 years. To reduce contamination effects, the unit of randomisation was school. Participants were randomly allocated to receive (i) a 12-week behavioural support intervention consisting of six appointments, (ii) a behavioural support intervention plus incentives (totalling £40), or (iii) an information-only control group. Behavioural support was provided by fitness advisors at local leisure centres following an initial consultation with a dietician. Sessions focused on promoting habit formation through setting implementation intentions as part of an incremental goal setting process. Consistent with self-determination theory, all advisors were trained to provide guidance in an autonomy-supportive manner so that they were equipped to create a social context supportive of autonomous forms of participant motivation. The primary outcome was objectively assessed physical activity (via GT1M accelerometers). Secondary outcome measures were diet, motivation and habit strength. Data were collected at baseline, post

  9. A multi-modal intervention for Activating Patients at Risk for Osteoporosis (APROPOS): Rationale, design, and uptake of online study intervention material.

    Science.gov (United States)

    Danila, Maria I; Outman, Ryan C; Rahn, Elizabeth J; Mudano, Amy S; Thomas, Tammi F; Redden, David T; Allison, Jeroan J; Anderson, Fred A; Anderson, Julia P; Cram, Peter M; Curtis, Jeffrey R; Fraenkel, Liana; Greenspan, Susan L; LaCroix, Andrea Z; Majumdar, Sumit R; Miller, Michael J; Nieves, Jeri W; Safford, Monika M; Silverman, Stuart L; Siris, Ethel S; Solomon, Daniel H; Warriner, Amy H; Watts, Nelson B; Yood, Robert A; Saag, Kenneth G

    2016-12-15

    implemented a novel tailored multi-modal intervention to improve initiation of osteoporosis therapy. An email address provided on the survey was the most important factor independently associated with accessing the intervention online. The design and uptake of this intervention may have implications for future studies in osteoporosis or other chronic diseases.

  10. A CLINICAL STUDY OF ACNE VULGARIS

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    Melathil Sadanandan Sadeep

    2017-11-01

    Full Text Available BACKGROUND Acne vulgaris is a highly prevalent chronic inflammatory disease of pilosebaceous unit affecting teenagers and young adults. Prognosis of acne is generally good, especially in mild acne. But, this disease reduces the self-esteem, their sense of identity and can severely compromise quality of life. All clinicians caring for children and adolescents should be familiar with this problem. Early diagnosis, proper treatment and timely counselling reduce the overall impact of disease to individuals. MATERIALS AND METHODS This is a prospective study conducted in the Department of Dermatology at Government Medical College, Kottayam, Kerala, in 200 patients who presented to the outpatient clinic with a clinical diagnosis of acne vulgaris who have not yet received any medical treatment for the disease and consented to participate in the study. RESULTS Male-to-female ratio of 1.43:1. 61.5% patients were in the 2nd decade. 4% were more than 30 years old. Duration of the disease at the time of presentation ranged from 3 weeks to 30 years. 42.5% complained of mild itching and 18.5% had burning sensation. 48.5% attribute exacerbation of disease after food intake. 72.5% acne patients had seborrhoea. Hirsutism and Acanthosis nigricans were present in 7.31% and 4.87% female patients, respectively. 50% with hirsutism and 25% with Acanthosis nigricans had polycystic ovarian disease and severe grades of acne. 25.6% females complained of premenstrual exacerbation of the disease. 26% of the patients showed exacerbation in summer. Smokers had severe grades of acne vulgaris compared to nonsmokers. Comedones were present in all and they were the predominant lesions in majority. Inflammatory papules were the 2nd most common lesions. Severe grades of acne were more common in patients with age ≥20 years. Severity of the disease increases with long duration of the disease. Relatively high incidence of post-acne scarring and post-inflammatory hyperpigmentation was

  11. Astigmatism treatment during phacoemulsification: a review of current surgical strategies and their rationale

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    Giuliano de Oliveira Freitas

    2013-12-01

    Full Text Available Preexisting corneal astigmatism, present at the time of cataract surgery, is reviewed in detail throughout this article on its most important aspects such as occurrence rates, clinical relevance and current treatment options. Special emphasis is given to the latter aspect. Each method's rationale, advantage and limitation ishigh lightened. Comparisons between treatment options, whenever possible, are also provided.

  12. Comparing the Effectiveness of a Clinical Registry and a Clinical Data Warehouse for Supporting Clinical Trial Recruitment: A Case Study

    Science.gov (United States)

    Weng, Chunhua; Bigger, J Thomas; Busacca, Linda; Wilcox, Adam; Getaneh, Asqual

    2010-01-01

    This paper reports a case study comparing the relative efficiency of using a Diabetes Registry or a Clinical Data Warehouse to recruit participants for a diabetes clinical trial, TECOS. The Clinical Data Warehouse generated higher positive predictive accuracy (31% vs. 6.6%) and higher participant recruitment than the Registry (30 vs. 14 participants) in a shorter time period (59 vs. 74 working days). We identify important factors that increase clinical trial recruitment efficiency and lower cost. PMID:21347102

  13. A CLINICAL STUDY OF ADHESIVE INTESTINAL OBSTRUCTION

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    Haricharan

    2015-09-01

    Full Text Available INTRODUCTION: Adhesive intestinal obstruction is an inevitable complication of abdominal surgeries. It has high morbidity with associated poor quality of life and predisposition to repeated hospitalization. Commonest cause of bowel obstruction in developed countries is postoperative adhesions with extrinsic compression of the intestine. Most of them can be managed conservatively. METHODS: A retrospective study of 30 patients admitted with the diagnosis of post - operative adhesive partial bowel obstruction was conducted by analyzing their medical records. Demographic data, clinical presentation including duration, previous surgical procedures, treatments received for the condition and successful conservative approach versus requirement of operative intervention were assesse d. RESULTS: The median age was 31yrs, most in their third decade of life. Male predominance was noted. Pelvic surgeries and gynecological surgeries (26% were found to be the most common cause of adhesive bowel obstruction followed by appendectomy (16%. M ore than two third of the patients (76.7% developed symptoms within two years of the initial surgery. Successful conservative treatment was noted in 22 patients (73.3% and discharged on fourth day of admission. Eight patients (26.6% underwent surgery. T hey all underwent adhesiolysis and had good outcome. CONCLUSIONS: The time - honored practice of expectant management of adhesive partial bowel obstruction has equally good outcome, as compared to various interventions practiced

  14. Clinical Study of Second Branchial Cleft Anomalies.

    Science.gov (United States)

    Lee, Dong Hoon; Yoon, Tae Mi; Lee, Joon Kyoo; Lim, Sang Chul

    2018-03-30

    The objective of this study was to review the clinical characteristics and surgical treatment outcomes of second branchial cleft anomalies, and to evaluate the usefulness and accuracy of preoperative fine-needle aspiration cytology (FNAC) in the diagnosis of branchial cleft cysts. A retrospective chart review was performed at Chonnam National University Hwasun Hospital from January 2010 to December 2016. Among 25 patients with second branchial cleft anomalies, in 23 patients (92.0%), these anomalies presented as cysts, and in the remaining 2 patients (8.0%), these anomalies presented as fistulas. Fine-needle aspiration cytology had a diagnostic sensitivity of 100%, a positive-predictive value of 100%, and accuracy of 100% for diagnosing second branchial cleft cyst. All patients of second branchial cleft anomalies were treated surgically under general anesthesia. No recurrence of second branchial cleft anomalies was observed. Branchial cleft cysts were the most common type of second branchial cleft anomalies. Preoperative FNAC is a useful and accurate method for preoperative evaluation of branchial cleft cysts. Surgical excision of second branchial cleft anomalies is the treatment of choice without any complications and with no recurrence.

  15. Clinical study of internal carotid artery occlusion

    International Nuclear Information System (INIS)

    Okada, Kyoko

    1989-01-01

    Fourteen patients with internal carotid artery (ICA) occlusion identified by cerebral angiography were studied for clinical features, computed tomographic findings, collateral circulation and risk factors. Eleven patients were males, and at age distribution it occurred more frequently in patients over 50 years to 60 years of age rather than other ages. As for the risk factors of cerebral infarction, smoking was more frequent in patients with thrombosis, and heart disease was more common in tho