Search results - Portal of Medical Data Models (MDM-Portal)

dbGaP phs000974 NHLBI TOPMed: Whole Genome Sequencing and Related Phenotypes in the Framingham Heart Study - Eligibility

- 12/1/23 - 4 forms, 1 itemgroup, 1 item, 1 language

Itemgroup: IG.elig

Principal Investigator: Vasan Ramachandran, Department of Medicine, Boston University School of Medicine, Boston, MA, USA MeSH: Cardiovascular Diseases,Atherosclerosis,Atrial Fibrillation,Death, Sudden, Cardiac,Diabetes Mellitus, Type 2,Heart Failure,Blood Pressure,Hypertension,Body Mass Index,Adiposity,Lipids,Pulmonary Disease, Chronic Obstructive,Renal Insufficiency, Chronic,Stroke,Osteoporosis,Risk Factors,Biological Markers,Biomarkers, Pharmacological https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000974 The Framingham Heart Study (FHS) is a prospective cohort study of 3 generations of subjects who have been followed up to 65 years to evaluate risk factors for cardiovascular disease. Its large sample of ~15,000 men and women who have been extensively phenotyped with repeated examinations make it ideal for the study of genetic associations with cardiovascular disease risk factors and outcomes. DNA samples have been collected and immortalized since the mid-1990s and are available on ~8000 study participants in 1037 families. These samples have been used for collection of GWAS array data and exome chip data in nearly all with DNA samples, and for targeted sequencing, deep exome sequencing and light coverage whole genome sequencing in limited numbers. Additionally, mRNA and miRNA expression data, DNA methylation data, metabolomics and other 'omics data are available on a sizable portion of study participants. This project will focus on deep whole genome sequencing (mean 30X coverage) in ~4100 subjects and imputed to all with GWAS array data to more fully understand the genetic contributions to cardiovascular, lung, blood and sleep disorders. Comprehensive phenotypic and pedigree data for study participants are available through dbGaP phs000007.

Collaborative Research Center | Transregio 240 (Sonderforschungsbereich Transregio 240) - Stroke Neurology (Schlaganfall Neurologie)

- 9/17/21 - 1 form, 4 itemgroups, 16 items, 1 language

Itemgroups: Patient-ID, Diagnosis: Further clinical diagnostics, Clinic end points during hospitalization: Severity level (NIHSS), Clinic endpoints during hospitalization: level of disability (mRS and Barthel Index)

A central patient cohort within the interdisciplinary Collaborative Research Center / Transregio 240 aims to examine the role and function of platelets in different vascular diseases. In this questionnaire specific items on stroke patients are collected. This form contains the modified Rankin Scale: Rankin J. Cerebral vascular accidents in patients over the age of 60: II. Prognosis Scottish Med J. 1957; 2: 200–215. This form contains the Barthel-Index: Mahoney F. Barthel D. Functional evaluation: the Barthel Index. Md Med J.1965; 14:61–65.

dbGaP phs000292 GENEVA Genetics of Early Onset Stroke (GEOS) Study - Eligibility

- 1/29/25 - 5 forms, 1 itemgroup, 2 items, 1 language

Itemgroup: IG.elig

Principal Investigator: Braxton D. Mitchell, PhD, University of Maryland, Baltimore, MD, USA MeSH: Stroke https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000292 The Genetics of Early Onset Stroke (GEOS) Study is a population-based case-control study designed to identify genes associated with early-onset ischemic stroke and to characterize interactions of identified stroke genes and/or SNPs with environmental risk factors such as smoking and oral contraceptive use. The GEOS study consists of 921 ischemic stroke cases with age of first stroke 16-50 years and a similar number of controls, identified from the Baltimore-Washington area. Cases and controls were recruited in 3 different time periods: Stroke Prevention in Young Women-1 (SPYW-1) conducted from 1992-1996, Stroke Prevention in Young Women-2 (SPYW-2) conducted from 2001-2003, and Stroke Prevention in Young Men (SPYM) conducted from 2003-2007. The overall GEOS sample includes 477 cases who self-reported their race as "white" and 396 cases who self-reported their race as "African American." Traditional stroke risk factors and other study variables, including age, ethnicity, and history of hypertension, diabetes, myocardial infarction (MI), current smoking status, and current oral contraceptive use (both defined as use within one month prior to event for cases and at a comparable reference time for controls), were also collected during standardized interview and were included as covariates in our analyses. This study is part of the Gene Environment Association Studies initiative (GENEVA, http://www.genevastudy.org) funded by the trans-NIH Genes, Environment, and Health Initiative (GEI). The overarching goal is to identify novel genetic factors that contribute to early-onset ischemic stroke through large-scale genome-wide association studies of cases and controls of European and African descent from the Baltimore-Washington area. Genotyping was performed at the Johns Hopkins University Center for Inherited Disease Research (CIDR). Data cleaning and harmonization were done at the GEI-funded GENEVA Coordinating Center at the University of Washington.

Stroke

pht001525.v1.p1

1 itemgroup 6 items

pht001526.v1.p1

1 itemgroup 4 items

pht001527.v1.p1

1 itemgroup 19 items

pht001524.v1.p1

1 itemgroup 4 items

dbGaP phs000944 eMERGE Clinical Center at Partners HealthCare - Eligibility

- 11/27/24 - 6 forms, 2 itemgroups, 11 items, 1 language

Itemgroups: IG.elig, IG.elig

Principal Investigator: Scott T. Weiss, MD, MS, Partners HealthCare System, Boston, MA, USA MeSH: Hypercholesterolemia,Asthma,Arthritis, Rheumatoid,Attention Deficit Disorder with Hyperactivity,Bipolar Disorder,Coronary Disease,Depression,Heart Failure,Inflammatory Bowel Diseases,Multiple Sclerosis,Schizophrenia,Stroke https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000944 The Partners HealthCare Biobank is a large research data and sample repository working within the framework of Partners Personalized Medicine. It provides researchers access to high quality, consented samples to help foster research, advance understanding of the causes of common diseases, and advance the practice of medicine. The Partners Biobank provides banked samples (plasma, serum and DNA) collected from consented patients. These samples are available for distribution to Partners HealthCare investigators with appropriate approval from the Partners Institutional Review board (IRB). They are linked to clinical data that originates in the Electronic Medical Record (EMR), as well as additional health information collected in a self-reported survey. The Partners Biobank will be genotyping 25,000 subjects with the Illumina Multiethnic Beadchip 1.6 million SNPs with exome and custom content ( 60,000 LoFs). Of the participants genotyped so far, 4929 of 4962 (99.3%) individuals have genotype data that passed the default quality thresholds for the Infinium array (call rate = 0.99). We are submitting the genotype data to dbGaP for 4929 subjects with 12 phenotypes (based on icd9 codes). We will do annual releases until we reach the full 25,000 genotyped subjects.

pht004847.v1.p1

1 itemgroup 5 items

pht005288.v1.p1

1 itemgroup 6 items

pht004844.v1.p1

1 itemgroup 2 items

pht004845.v1.p1

1 itemgroup 3 items

pht004846.v1.p1

1 itemgroup 18 items

dbGaP phs000925 PAGE: IPM BioMe Biobank - Eligibility

- 4/28/24 - 5 forms, 1 itemgroup, 1 item, 1 language

Itemgroup: IG.elig

Principal Investigator: Ruth Loos, PhD, The Charles Bronfman Institute for Personalized Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA MeSH: Cardiovascular Diseases,Obesity,Diabetes Mellitus, Type 2,Glucose,Kidney Failure, Chronic,Cholesterol, HDL,Cholesterol, LDL,Triglycerides,Coronary Disease,Myocardial Infarction,Inflammation,Stroke,Body Height https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000925 The Institute for Personalized Medicine (IPM) Bio*Me* Biobank is a consented, EMR-linked medical care setting biorepository of the Mount Sinai Medical Center (MSMC) drawing from a population of over 70,000 inpatients and 800,000 outpatient visits annually. MSMC serves diverse local communities of upper Manhattan, including Central Harlem (86% African American), East Harlem (88% Hispanic Latino), and Upper East Side (88% Caucasian/white) with broad health disparities. IPM Bio*Me* Biobank populations include 28% African American, 38% Hispanic Latino predominantly of Caribbean origin, 23% Caucasian/White. IPM BioMe Biobank disease burden is reflective of health disparities with broad public health impact. Biobank operations are fully integrated in clinical care processes, including direct recruitment from clinical sites waiting areas and phlebotomy stations by dedicated Biobank recruiters independent of clinical care providers, prior to or following a clinician standard of care visit. Recruitment currently occurs at a broad spectrum of over 30 clinical care sites. This study is part of the Population Architecture using Genomics and Epidemiology (PAGE) study (phs000356).

pht005176.v1.p1

1 itemgroup 4 items

pht005178.v1.p1

1 itemgroup 6 items

pht006203.v1.p1

1 itemgroup 6 items

pht005177.v1.p1

1 itemgroup 5 items

dbGaP phs000546 NHLBI GO-ESP: Heart Cohorts Exome Sequencing Project (ISGS) - Eligibility

- 12/13/22 - 5 forms, 1 itemgroup, 2 items, 1 language

Itemgroup: IG.elig

Principal Investigator: Stephen Rich, PhD, University of Virginia, Charlottesville, VA, USA MeSH: Stroke,Brain Ischemia https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000546 The NHLBI "Grand Opportunity" Exome Sequencing Project (GO-ESP), a signature project of the NHLBI Recovery Act investment, was designed to identify genetic variants in coding regions (exons) of the human genome (the "exome") that are associated with heart, lung and blood diseases. These and related diseases that are of high impact to public health and individuals from diverse racial and ethnic groups will be studied. These data may help researchers understand the causes of disease, contributing to better ways to prevent, diagnose, and treat diseases, as well as determine whether to tailor prevention and treatments to specific populations. This could lead to more effective treatments and reduce the likelihood of side effects. GO-ESP is comprised of five collaborative components: 3 cohort consortia - HeartGO, LungGO, and WHISP - and 2 sequencing centers - BroadGO and SeattleGO. The Ischemic Stroke Genetics Study (ISGS) is a study of newly onset cases (~600) with ischemic stroke (a stroke due to sudden interruption of blood flow to a part of the brain) compared with sex- and age-matched non-stroke participants. The study was conducted to determine the genes and their variants that contribute to an individual's risk of developing an ischemic stroke. The coordination of the recruitment and flow of the samples occurred at the Mayo Clinic, Jacksonville, FL, under the direction of James F. Meschia, MD. The University of Virginia (Stephen S. Rich, PhD) served as the analytic site for the genetic data. All GWAS data on ISGS participants have been deposited into dbGaP. As part of the NHLBI Exome Sequencing Project, DNA from a subset of ISGS participants will undergo exome sequencing. For the NHLBI ESP, a subset of 92 individuals with lacunar (small vessel) or atherosclerotic (large vessel) TOAST subtypes were selected from among all ISGS participants, excluding those individuals with TOAST subtypes of stroke of other etiology or of stroke with undetermined etiology. All 92 samples pass initial quality control metrics and 89 samples completed exome sequencing. A total of 75 participants with appropriate consent and variant calls had their genetic and phenotypic data deposited into dbGaP.

pht003141.v1.p1

1 itemgroup 2 items

pht003142.v1.p1

1 itemgroup 7 items

pht003143.v1.p1

1 itemgroup 22 items

pht003144.v1.p1

1 itemgroup 5 items

Eligibility NCT01120301 Acute Ischemic Stroke - Eligibility

- 9/27/21 - 1 form, 2 itemgroups, 21 items, 2 languages

Itemgroups: Inclusion Criteria, Exclusion Criteria

ODM derived from http://clinicaltrials.gov/show/NCT01120301

CHA2DS2-VASc score

- 9/27/21 - 1 form, 1 itemgroup, 8 items, 1 language

Itemgroup: CHADS2

The CHA2DS2-VASc is a simple stroke risk stratification schema for patients with atrial fibrillation which is based on a risk factor approach and provides some improvement in predictive value for TE over the CHADS 2 schema. Reference: Lip, G. Y., Nieuwlaat, R., Pisters, R., Lane, D. A., & Crijns, H. J. (2010). Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest Journal, 137(2), 263-272.

Eligibility Stroke NCT00839657

- 9/20/21 - 1 form, 2 itemgroups, 18 items, 1 language

Itemgroups: Inclusion Criteria, Exclusion Criteria

Clarification of Optimal Anticoagulation Through Genetics; ODM derived from: https://clinicaltrials.gov/show/NCT00839657

ICHOM Conditions and Treatment Approaches Covered for Stroke - Index event - Clinical

- 9/20/21 - 1 form, 5 itemgroups, 18 items, 1 language

Itemgroups: Administrative data, Demographic factors, Stroke type and severity, Vascular and systemic, Treatment/care related

ICHOM Stroke data collection Version 2.0.1 Revised: June 21th, 2018 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. For stroke, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Patients who have been hospitalized for an index ischemic stroke (IS) or intracereberal hemorrhage (ICH). Patients with subarachnoid hemorrhage (SAH) are excluded. Inclusion of transient ischemic attack (TIA) or patients with IS or ICH who are evaluated but not hospitalized is not required. Treatment Approaches: IV Thrombolysis | Thrombectomy | Hemicraniectomy This form contains index event clinical form. The items cover the entrance into outcome tracking system for Stroke. If a second stroke occurs between discharge and the “90 day post index” collection, you should reset the measurement scale, treating them as a new patient. Questionnaires used in this standard set: PROMIS-10. It is free for all health care organizations, and a license is not needed. There are translations available for Spanish, French, German,and Dutch. As http://www.nihpromis.org is the official distribution site for PROMIS questionnaires and translations, only the total score will be included in this version of the standard set. Simplified Modified Rankin Scale Questionnaire (smRSq) – Clinician. There is no patent on thes smRSq or fee for using it in clinical practice; however Lippincott Williams & Wilkins (LWW) own the rights to the published article where the smRSq is introduced. Therefore here only the total score is included. The smRSq flow chart can be found at http://stroke.ahajournals.org/content/42/8/2276 “Simplified Modified Rankin Scale Questionnaire Reproducibility Over the Telephone and Validation With Quality of Life” Stroke 2011; 42: 2276-2279 © 2011 American Heart Association, Inc. Wolters Kluwer Health. Publication: Salinas J, Sprinkhuizen SM, Ackerson T, et al. An International Standard Set of Patient-Centered Outcome Measures After Stroke. Stroke. 2015;47(1):180–186. doi:10.1161/STROKEAHA.115.010898 For the Stroke Standard Set ICHOM was supported by the American Heart Association and the American Stroke Association. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989 - Eligibility Criteria

- 9/20/21 - 1 form, 4 itemgroups, 33 items, 1 language

Itemgroups: Administrative Data, Eligibility question, Inclusion Criteria, Exclusion Criteria

Study ID: 111539 Clinical Study ID: 111539 Study Title: A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of scalating Repeat Doses of GSK249320 in Patients With Stroke Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00833989 https://clinicaltrials.gov/ct2/show/NCT00833989 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Refanezumab, Placebo Trade Name: N/A Study Indication: Ischaemic Attack, Transient The study consists of 8 visits: Day 1, Week 1 (Day 5), Week 2 (Day 10), Week 4 (Day 30), Week 8 (Day 60), Week 12 (Day 90), Week 16 (Day 112), Follow-up (F/U). All subjects will receive two doses. The first dose within 24-72 hrs after stroke the second dose 9 +/- 1 days after the first one. Each dose will be given as an intravenous infusion over 60 minutes. This document contains the eligibility criteria. It has to be filled in at Day 1.

Data quality assurance of stroke acute treatment Hessen - SAB / Intracerebral haemorrhage - End of Treatment

- 9/20/21 - 7 forms, 6 itemgroups, 28 items, 3 languages

Itemgroups: Sekundärprophylaxe, Neurologischer Befund, Dysphagie/Aphasie/Dysarthrie, Behinderung, Information von Patient und/oder Angehörigen vor Entlassung, Entlassung

Quality Assurance Hessen, Eschborn Document: record stroke acute treatment (phase A) As of 05/01/2015 File: SA_HE_2015_V04_Bogen

Keywords

Table of contents

Selected data models

Contact

Help