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dbGaP phs000360 eMERGE Network Combined Dataset - Eligibility

- 2022-10-12 - 7 Formulär, 1 Item-grupp, 10 Dataelement, 1 Språk

Item-grupp: IG.elig

Principal Investigator: Rex Chisholm, PhD, Northwestern University, Evanston, IL, USA MeSH: Electronic Health Records,Hematologic Diseases,Chronic Disease,Anthropometry,Lipids,Diabetic Retinopathy,Hypothyroidism https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000360 The **e**lectronic **M**edical **R**ecords and **Ge**nomics (eMERGE) Network is a consortium of five participating sites (Group Health Seattle, Marshfield Clinic, Mayo Clinic, Northwestern University, and Vanderbilt University) funded by the NHGRI to investigate the use of electronic medical record systems for genomic research. The goal of eMERGE is to conduct genome-wide association studies in approximately 19,000 individuals using EMR-derived phenotypes and DNA from linked Biorepositories. Using electronic phenotyping methods, the consortium used DNA samples from all participating sites to explore the genetic determinants of red cell indices, white blood count (WBC) differential, diabetic retinopathy, height, serum lipid levels, specifically total cholesterol, HDL (high density lipoprotein), LDL (low density lipoprotein), and triglycerides, and autoimmune hypothyroidism as well as using the phenome-wide association study (PheWAS) paradigm to replicate and discover relationships between targeted genotypes with multiple phenotypes. eMERGE led studies for which original genotyping was performed and are included in this merged set: - Genome-Wide Association Study on Cataract and HDL in the Personalized Medicine Research Project Cohort, phs000170 - Development and Use of Network Infrastructure for High-Throughput GWA Studies, phs000234 - Vanderbilt Genome-Electronic Records (VGER) Project: QRS Duration, phs000188 - Northwestern NUgene Project: Type 2 Diabetes, phs000237 - A Genome-Wide Association Study of Peripheral Arterial Disease, phs000203 Sites and participants include: *Vanderbilt University:* BioVU, Vanderbilt's DNA databank, is an enabling resource for exploration of the relationships among genetic variation, disease susceptibility, and variable drug responses, and represents a key first step in moving the emerging sciences of genomics and pharmacogenomics from research tools to clinical practice. BioVU acquires DNA from discarded blood samples collected from routine patient care. The biobank is linked to de-identified clinical data extracted from Vanderbilt's EMR, which forms the basis for phenotype definitions used in genotype-phenotype correlations. *Marshfield Clinic:* The Marshfield Clinic Personalized Medicine Research Project is a population-based biobank in central Wisconsin with more than 20,000 adult subjects who provided written, informed consent to access their medical records and provided a blood sample from which DNA was extracted and plasma and serum stored. In addition to an average of 30 years of medical history data, a questionnaire about environmental exposures, including a detailed food frequency questionnaire, is available to facilitate gene/environment studies. *Northwestern University:* The NUgene Project is a repository with longitudinal medical information from participating patients at affiliated hospitals and outpatient clinics from the Northwestern University Medical Center. Participants' DNA samples are coupled with data from a self-reported questionnaire and continuously updated data from our Electronic Medical Record (EMR) representing actual clinical care events. Northwestern has a state-of-the art, comprehensive inpatient and outpatient EMR system of over 2 million patients. NUgene has broad access to participant data for all outpatient visits as well as inpatient data via a consolidated data warehouse. NUgene participants consent to distribution and use of their coded DNA samples and data for a broad range of genetic research by third-party investigators. *Group Health(GH)/University of Washington (UW):* Aging and Dementia eMERGE study biorepository leverages rich population-based longitudinal data from both electronic medical records and in-depth research data to explore genome wide associations. Participants include Seattle-area members of GH (a large integrated health care system in Washington State) consented and enrolled in 1) the UW Alzheimer's Disease Patient Registry (ADPR) and 2) the Adult Changes in Thought (ACT) study. The ADPR (PI: Eric B. Larson; NIH/NIA U01 AG 006781) is a population-based registry of incident dementia cases designed to identify all new Alzheimer's Disease cases within GH from 1987 to 1996. Medical history, physical, laboratory testing, and neuropsychological testing were performed on all consenting potential cases for determination of dementia status by a consensus conference. The study base of the ADPR population was stable with an attrition rate of less than 1%/year. The ACT study (PI: Eric B. Larson; NIH/NIA U01 AG 006781) is an ongoing community-based cohort study of aging and dementia. The original cohort of 2,581 randomly selected dementia-free members age 65 and older was enrolled in 1994-1996 and expanded by 811 in 2000-2002. Continuous enrollment to maintain a cohort of 2,000 dementia free persons began in 2005. Participants receive biennial assessment including cognitive status determination. The ACT sub-sample is stable; for the original cohort, median enrollment in GH was 19 years prior to joining the ACT study, and 85% of the cohort has ≥10 years of GH enrollment. DNA for the ADPR participants were obtained through a companion study, Genetic Differences in Cases and Controls (PI: Walter Kukull; NIH/NIA R01 AG007584). DNA obtained through both studies were extracted from blood using Gentra Systems Puregene methods. DNA concentration is determined by UV optical density. All samples are checked for quality by 260/280 ratio. For long-term storage, samples are aliquoted and stored at -70°C. *Mayo Clinic:* The Mayo biobank is a disease-specific biobank for vascular diseases including peripheral arterial disease (PAD). PAD patients were identified from individuals referred to the non-invasive vascular laboratory for lower extremity arterial evaluation. Since 1997, laboratory findings have been recorded into an electronic database employing an in-house software package for data archiving and retrieval; this data becomes part of the Mayo EMR. Patients referred to the center with suspected PAD undergo a comprehensive non-invasive evaluation including the ankle-brachial index (ABI) - the ratio of blood pressure measured in the upper arms divided by blood pressure measured at the ankles. Controls subjects are identified from patients referred to the Cardiovascular Health Clinic for stress ECG. The prevalence of PAD in patients with normal exercise capacity who do not have inducible ischemia on the stress ECG, was 1%. Data regarding risk factors for atherosclerosis such as diabetes, dyslipidemia, hypertension, and smoking are ascertained from the EMR.

pht003252.v2.p1

1 Item-grupp 6 Dataelement

pht003251.v2.p1

1 Item-grupp 4 Dataelement

pht003253.v2.p1

1 Item-grupp 6 Dataelement

pht003256.v2.p1

1 Item-grupp 2 Dataelement

pht003254.v3.p1

1 Item-grupp 3 Dataelement

pht003255.v2.p1

1 Item-grupp 73 Dataelement

Persönliches Interview SHIP-Trend-1 Liste chronischer Erkrankungen

- 2021-02-13 - 1 Formulär, 1 Item-grupp, 81 Dataelement, 1 Språk

Item-grupp: Liste chronischer Erkrankungen

Liste chronischer Erkrankungen form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name TREND.TREND1.INT.CHRO.CHRO. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617

Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037 - Childbearing potential

- 2019-10-17 - 1 Formulär, 2 Item-grupper, 4 Dataelement, 1 Språk

Item-grupper: Administrative Data, Childbearing potential

Study ID: 108062 Clinical Study ID: 108062 Study Title: A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00908037 https://clinicaltrials.gov/ct2/show/NCT00908037 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: eltrombopag, Placebo Trade Name: N/A Study Indication: Purpura, Thrombocytopaenic, Idiopathic The study consists of a screening, Day 1 and three parts. All subjects were supposed to receive 24 weeks (6 months) of eltrombopag treatment during Part 2/3. Screening period: Up to 28 days prior to Day 1 of treatment. Day 1 Part 1 (Dose Finding Phase): A 24-week (6 months) open label treatment period for 5 subjects in each age cohort. (short: P1W1-P1W7, P1W8-23, P1W24/EW). A safety, PK and platelet count review took place after 12 weeks (3 months) of treatment. Subjects in the Dose Finding Phase did not participate in the Randomized Period. Part 2 (Randomized Period): A 7-week randomized, double-blind, placebo-controlled period involving 18 subjects per cohort (short: P2W1-P2W7). Part 3: An open-label treatment period where subjects randomized to eltrombopag in Part 2 received an additional 17 weeks of eltrombopag in Part 3 and subjects randomized to placebo in Part 2 received 24 weeks of eltrombopag in Part 3 (short: P3W8-P3W23, P3W24/EW, P3W8-30, P3W31/EW). Follow-up: 4 weeks following the last dose of eltrombopag (short: FUW1- FUW4). Additional ocular examinations were performed at 12 and 24 weeks (3 and 6 months) after the last dose of eltrombopag (short: FUM3, FUM6). The subjects were enrolled in 3 cohorts: Cohort 1: Subjects between 12 and 17 years old (<18 years of age at Day 1). Cohort 2: Subjects between 6 and 11 years old (<12 years of age at Day 1). Cohort 3: Subjects between 1 and 5 years old (<6 years of age at Day 1). The enrollment was started with the oldest cohort (Cohort 1). The younger cohorts were not enrolled until safety, PK and platelet counts had been reviewed in the older cohort(s). This document contains the Childbearing potential form.

Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037 - Demography

- 2019-10-16 - 1 Formulär, 4 Item-grupper, 15 Dataelement, 1 Språk

Item-grupper: Administrative Data, Demography, Ethnicity, Geographic ancestry

Study ID: 108062 Clinical Study ID: 108062 Study Title: A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00908037 https://clinicaltrials.gov/ct2/show/NCT00908037 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: eltrombopag, Placebo Trade Name: N/A Study Indication: Purpura, Thrombocytopaenic, Idiopathic The study consists of a screening, Day 1 and three parts. All subjects were supposed to receive 24 weeks (6 months) of eltrombopag treatment during Part 2/3. Screening period: Up to 28 days prior to Day 1 of treatment. Day 1 Part 1 (Dose Finding Phase): A 24-week (6 months) open label treatment period for 5 subjects in each age cohort. (short: P1W1-P1W7, P1W8-23, P1W24/EW). A safety, PK and platelet count review took place after 12 weeks (3 months) of treatment. Subjects in the Dose Finding Phase did not participate in the Randomized Period. Part 2 (Randomized Period): A 7-week randomized, double-blind, placebo-controlled period involving 18 subjects per cohort (short: P2W1-P2W7). Part 3: An open-label treatment period where subjects randomized to eltrombopag in Part 2 received an additional 17 weeks of eltrombopag in Part 3 and subjects randomized to placebo in Part 2 received 24 weeks of eltrombopag in Part 3 (short: P3W8-P3W23, P3W24/EW, P3W8-30, P3W31/EW). Follow-up: 4 weeks following the last dose of eltrombopag (short: FUW1- FUW4). Additional ocular examinations were performed at 12 and 24 weeks (3 and 6 months) after the last dose of eltrombopag (short: FUM3, FUM6). The subjects were enrolled in 3 cohorts: Cohort 1: Subjects between 12 and 17 years old (<18 years of age at Day 1). Cohort 2: Subjects between 6 and 11 years old (<12 years of age at Day 1). Cohort 3: Subjects between 1 and 5 years old (<6 years of age at Day 1). The enrollment was started with the oldest cohort (Cohort 1). The younger cohorts were not enrolled until safety, PK and platelet counts had been reviewed in the older cohort(s). This document contains the demography form. It has to be filled in for screening.

KBV Determination of severe chronical disease Template 55

- 2017-09-07 - 1 Formulär, 3 Item-grupper, 20 Dataelement, 1 Språk

Item-grupper: Header, Diagnoses, Patient information

Muster 55 - Bescheinigung zum Erreichen der Belastungsgrenze bei Feststellung einer schwerwiegenden chronischen Krankheit im Sinne des § 62 SGB V(Freigabe 10.11.2008). Freigabe durch Dezernat 4 - Ärztliche Leistungen und Versorgungsstruktur Geschäftsbereich Sicherstellung und Versorgungsstruktur Abteilung Sicherstellung Herbert-Lewin-Platz 2 10623 Berlin Tel: + 49 (0) 30 - 4005 -1418 Fax: + 49 (0) 30 - 4005 - 271418 Email: SJohn@KBV.de Web: www.kbv.de Quelle: http://www.kbv.de/html/formulare.php --- Template 55 - Determination of severe chronical disease (Released 11-10-2008). Released by Department 4 - Medical treatment and structure of supply, division ensurance and structure of supply, department ensurance Herbert-Lewin-Platz 2 10623 Berlin Tel: + 49 (0) 30 - 4005 -1418 Fax: + 49 (0) 30 - 4005 - 271418 Email: SJohn@KBV.de Web: www.kbv.de Source: http://www.kbv.de/html/formulare.php

Eligibility Chronic Kidney Disease NCT01462097

- 2016-02-23 - 1 Formulär, 2 Item-grupper, 13 Dataelement, 1 Språk

Item-grupper: Inclusion Criteria, Exclusion Criteria

Exercise Trial in Chronic Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01462097

Riliva_CRF_EudraCT - Nr. 2012-000108-13- Anamnesis DRKS00004652 - Anamnesis

- 2015-11-24 - 2 Formulär, 5 Item-grupper, 66 Dataelement, 2 Språk

Item-grupper: Livedoid vasculitis anamnesis, Therapy Livedoid vasculitis, Comorbidities chronic, Family anamnesis Livedoid vasculitis, Blood Coagulation Disorders

Study documentation part: Anamnesis. This is a phase II multicenter trial with Rivaroxaban in the treatment of livedoid vasculopathy assessing the pain on a visual analog scale (VAS). Principal Investigator PD Dr. Tobias Görge, University Hospital of Münster. EudraCT - Nr. 2012-000108-13.

Laboratory values

1 Item-grupp 32 Dataelement

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