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Table des matières
  1. 1. Klinische Studie
  2. 2. Routinedokumentation
  3. 3. Register-/Kohortenstudien
  4. 4. Qualitätssicherung
  5. 5. Datenstandard
  6. 6. Patientenfragebogen
  7. 7. Medizinische Fachrichtung
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Eligibility NCT00322621 Diabetic Neuropathies - Eligibility

- 11.08.14 - 1 Formulaire, 2 Groupes Item, 9 Eléments de données, 2 Langues
Groupes Item: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT00322621

LASER ADMINISTRATION FELLOW EYE (UNSCHEDULED) CRFs Roche FVF4170G Macular Edema NCT00473382

- 28.06.17 - 1 Formulaire, 2 Groupes Item, 10 Eléments de données, 1 Langue
Groupes Item: Patient administration, LASER ADMINISTRATION STUDY EYE
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

dbGaP phs000428 Health and Retirement Study (HRS) - pht005036.v1.p2

- 29.01.25 - 6 Formulaires, 1 Groupe Item, 4 Eléments de données, 1 Langue
Groupe Item: pht005036
Principal Investigator: David Weir, PhD, University of Michigan, Ann Arbor, MI, USA MeSH: Aging,Neoplasms,Arthritis,Lung Diseases, Obstructive,Dementia,Heart Diseases,Heart Failure,Hypertension,Myocardial Infarction,Diabetes Mellitus,Hypercholesterolemia,Obesity,Body Weight,Mobility Limitation,Pain,Cholesterol,Hemoglobin A, Glycosylated,C-Reactive Protein,Cystatin C,Depression,Alcohol Drinking,Smoking,Personality,Life Style,Cognition,Demography,Ethnic Groups,Health Status,Population Groups,Housing,Independent Living,Socioeconomic Factors,Career Mobility,Educational Status,Employment,Family Characteristics,Income,Occupations,Poverty,Social Change,Social Class,Social Conditions,Risk Factors https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000428 *Introduction to V2: *This data release comprises data from the V1 release combined with approximately 3,000 additional samples, collected during the HRS 2010 field period. The 2010 data include samples from a random half of the new cohort enrolled in 2010 along with a significant expansion of the minority sample. *Description:* The University of Michigan Health and Retirement Study (HRS) is a longitudinal panel study that surveys a representative sample of approximately 20,000 people in America over the age of 50 every two years. Supported by the National Institute on Aging (NIA U01AG009740) and the Social Security Administration, the HRS explores the changes in labor force participation and the health transitions that individuals undergo toward the end of their work lives and in the years that follow. The study collects information about income, work, assets, pension plans, health insurance, disability, physical health and functioning, cognitive functioning, and health care expenditures. Through its unique and in-depth interviews, the HRS provides an invaluable and growing body of multidisciplinary data that researchers can use to address important questions about the challenges and opportunities of aging. Because of its innovation and importance, the HRS has become the model and hub for a growing network of harmonized longitudinal aging studies around the world. *Origins of the HRS.* As the population ages it is increasingly important to obtain reliable data about aging and topics that are relevant to a range of policy issues in aging. To address this need, the National Institutes on Aging (NIA) established a cooperative agreement with the University of Michigan Institute for Social Research to collect such data. The HRS launched data collection in 1992 and has re-interviewed the original sample of respondents every two years since then. By adding new cohorts and refreshing the sample, the HRS has grown to become the largest, most representative longitudinal panel study of Americans 50 years and older. *HRS Study Design.* The target population for the original HRS cohort includes all adults in the contiguous United States born during the years 1931-1941 who reside in households, with a 2:1 oversample of African-American and Hispanic populations. The original sample is refreshed with new birth cohorts (51-56 years of age) every six years. The sample has been expanded over the years to include a broader range of birth cohorts as well. The target population for the AHEAD survey consists of United States household residents who were born in 1923 or earlier. Children of the Depression (CODA) recruits households born 1924-1930, War Babies 1942-47, Early Boomers 1948-53, and Mid-Boomers 1954-59. Data collection includes a mixed mode design combining in-person, telephone, mail, and Internet. For consenting respondents, HRS data are linked at the individual level to administrative records from Social Security and Medicare claims. *Genetic Research in the HRS.* The HRS has genotyped 2.5 million single nucleotide polymorphisms (SNPs) on respondents using Illumina's Human Omni2.5-Quad (Omni2.5) BeadChip. The genotyping was performed by the NIH Center for Inherited Disease Research (CIDR). Saliva was collected on half of the HRS sample each wave starting in 2006. In 2006, saliva was collected using a mouthwash collection method. From 2008 onward, the data collection method switched to the Oragene kit. Saliva completion rates were 83% in 2006, 84% in 2008, and 80% in 2010 among new cohort enrollees. HRS Phenotypic data. Phenotypic data are available on a variety of dimensions. Health measures include physical/psychological self-report, various health conditions, disabilities, cognitive performance, health behaviors (smoking, drinking, exercise), physical performance and anthropomorphic measures, and biomarkers (HbA1c, Total Cholesterol, HDL, CRP, Cystatin-C). Data are also available on health services including utilization, insurance and out-of-pocket spending with linkage to Medicare records. Economic measures include employment status/history, earnings, disability, retirement, type of work, income by source, wealth by asset type, capital gains/debt, consumption, linkage to pensions, Social Security earnings/benefit histories. There is also extensive information on family structure, proximity, transfers to/from of money, time, social and psychological characteristics, as well as a wide range of demographics. Performance on a cognitive test combining immediate and delayed word recall was selected as an example trait for the dbGaP data release. In the immediate word recall task the interviewer reads a list of 10 nouns to the respondent and asks the respondent to recall as many words as possible from the list in any order. After approximately five minutes of asking other survey questions, the respondent is asked to recall the nouns previously presented as part of the immediate recall task. The total recall score is the sum of the correct answers to these two tasks, with a range of 0 to 20. Researchers who wish to link to other HRS measures not in dbGaP will be able to apply for access from HRS. A separate Data Use Agreement (DUA) will be required for linkage to the HRS data. See the HRS website (http://hrsonline.isr.umich.edu/gwas) for details.

Eligibility

1 Groupe Item 6 Eléments de données

pht002612.v2.p2

1 Groupe Item 4 Eléments de données

pht002613.v2.p2

1 Groupe Item 5 Eléments de données

pht002614.v2.p2

1 Groupe Item 7 Eléments de données

pht005037.v1.p2

1 Groupe Item 5 Eléments de données

CONCURRENT OCULAR PROCEDURES (DAY 0 - MONTH 12) CRFs Roche FVF4170G Macular Edema NCT00473382

- 11.06.17 - 1 Formulaire, 3 Groupes Item, 12 Eléments de données, 1 Langue
Groupes Item: Patient administration, CONCURRENT OCULAR PROCEDURES (DAY 0 - MONTH 12), Procedure
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

SUBJECT ELIGIBILITY (SCREENING) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

- 08.06.17 - 1 Formulaire, 3 Groupes Item, 9 Eléments de données, 1 Langue
Groupes Item: Patient administration, SUBJECT ELIGIBILITY, Eligibility Criteria Not Met
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

German Center for Diabetes Research (DZD) - Core Data Set - Base set

- 15.07.24 - 2 Formulaires, 8 Groupes Item, 147 Eléments de données, 2 Langues
Groupes Item: IG.1, IG.2, IG.3, IG.4, IG.5, IG.6, IG.7, Fragebogen
The German Center for Diabetes Research (DZD) has created a core data set for research on diabetes. It is published with permission by the DZD. The complete metadata and SOP are registered at DOI 10.5281/zenodo.7360000 For more information on the work of the DZD see: www.dzd-ev.de/en or contact: studien@dzd-ev.de German Center for Diabetes Research (DZD) Head Office at Helmholtz Zentrum München Ingolstädter Landstr. 1 85764 Neuherberg, Germany The German and English version of the Baecke Questionnaire in this core data set is based on the original paper by Baecke et al (https://doi.org/10.1093/ajcn/36.5.936), redistributed by ten Velde et al. (https://doi.org/10.1371/journal.pone.0256448), and the German translation and modification by Wagner & Singer (2003). The questionnaire was selectively modified by the German Diabetes Center (DDZ). Changes in this version 4 (15.07.2024) compared to version 3 (26.02.2024) include the addition of the parameters defined in the core data set of the German Centers for Health Research (DZG) (ID of MDM entry: 45851), the addition of laterality-specific blindness and an update of the terminology coding. The coding of the DZG parameters is currently under revision and not included in this current version. The coding of those DZG parameters that were already included in the DZD CDS will be provisionally retained.

Optional Set

3 Groupes Item 46 Eléments de données

dbGaP phs000964 NHLBI TOPMed: The Jackson Heart Study (JHS) - Eligibility

- 22.01.24 - 5 Formulaires, 1 Groupe Item, 1 Élément de données, 1 Langue
Groupe Item: IG.elig
Principal Investigator: Adolfo Correa, MD, MPH, PhD, Jackson Heart Study, University of Mississippi Medical Center, Jackson, MS, USA MeSH: Cardiovascular Diseases,Hypertension,Diabetes Mellitus https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000964 Since there is a greater prevalence of cardiovascular disease among African Americans, the purpose of the Jackson Heart Study (JHS) is to explore the reasons for this disparity and to uncover new approaches to reduce it. The JHS is a large, community-based, observational study whose 5306 participants were recruited from among the non-institutionalized African-American adults from urban and rural areas of the three counties (Hinds, Madison, and Rankin) that make up the Jackson, MS, metropolitan statistical area (MSA). Jackson is the capital of Mississippi, the state with the largest percentage (36.3%) of African Americans in the United States. The JHS design included participants from the Jackson ARIC study who had originally been recruited through random selection from a drivers' license registry. Approximately six months before the JHS was to begin, an amendment to the federal Driver's Privacy Protection Act was passed that changed the level of consent for public release of personal information from driver's license lists from an "opt out" to an "opt in" basis. The Mississippi Highway Patrol was no longer able to release a complete listing of all persons with driver's licenses or state identification cards, which prevented its use in the JHS. New JHS participants were chosen randomly from the Accudata America commercial listing, which provides householder name, address, zip code, phone number (if available), age group in decades, and family components. The Accudata list was deemed to provide the most complete count of households for individuals aged 55 years and older in the Jackson MSA. A structured volunteer sample was also included in which demographic cells for recruitment were designed to mirror the eligible population. Enrollment was opened to volunteers who met census-derived age, sex, and socioeconomic status (SES) eligibility criteria for the Jackson MSA. In addition, a family component was included in the JHS. The sampling frame for the family study was a participant in any one of the ARlC, random, or volunteer samples whose family size met eligibility requirements. Eligibility included having at least two full siblings and four first degree relatives (parents, siblings, children over the age of 21) who lived in the Jackson MSA and who were willing to participate in the study. No upper age limit was placed on the family sample. Known contact information was obtained during the baseline clinic examination from the index family member with a verbal pedigree format to identify name(s), age(s), address (es), and telephone number(s). Recruitment was limited to persons 35-84 years old except in the family cohort, where those 21 years old and above were eligible. Only persons who otherwise met study criteria but were deemed to be physically or mentally incompetent by trained recruiters were excluded from study eligibility.sup1/sup sup1/sup Wyatt SB, Diekelmann N, Henderson F, Andrew ME, Billingsley G, Felder SH et al. A community-driven model of research participation: the Jackson Heart Study Participant Recruitment and Retention Study. Ethn Dis 2003; 13(4):438-455 (PMID: 14632263).

pht004838.v1.p1

1 Groupe Item 4 Eléments de données

pht004839.v3.p1

1 Groupe Item 2 Eléments de données

pht004840.v2.p1

1 Groupe Item 11 Eléments de données

pht005766.v2.p1

1 Groupe Item 7 Eléments de données

dbGaP phs001012 The Diabetes Heart Study (DHS) - Eligibility

- 26.10.23 - 6 Formulaires, 1 Groupe Item, 2 Eléments de données, 1 Langue
Groupe Item: IG.elig
Principal Investigator: Donald W. Bowden, Wake Forest School of Medicine, Winston-Salem, NC, USA MeSH: Cardiovascular Diseases,Vascular Calcification,Diabetes Mellitus https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001012 The Diabetes Heart Study is a family based study enriched for type 2 diabetes (T2D). The cohort included 1220 self-reported European Americans from 475 families (Bowden et al 2010 Review of Diabetic Studies 7:188-201: PMID: 21409311; Bowden et al 2008 Annals of Human Genetics 72:598-601 PMID: 18460048) and included siblings concordant for T2D; where possible unaffected siblings were also recruited. The cohort was recruited between 1998 and 2006. Participants were extensively phenotyped for measures of subclinical CVD and other known CVD risk factors. Primary outcomes were quantified burden of vascular calcified plaque in the coronary artery, carotid artery and abdominal aorta all determined from non-contrast computed tomography scans.

pht005547.v1.p1

1 Groupe Item 2 Eléments de données

pht005548.v1.p1

1 Groupe Item 5 Eléments de données

pht005549.v1.p1

1 Groupe Item 3 Eléments de données

pht005550.v1.p1

1 Groupe Item 16 Eléments de données

pht005551.v1.p1

1 Groupe Item 3 Eléments de données

dbGaP phs001345 NHLBI TOPMed: Genetic Epidemiology Network of Arteriopathy (GENOA) - Eligibility

- 05.03.23 - 4 Formulaires, 1 Groupe Item, 6 Eléments de données, 1 Langue
Groupe Item: IG.elig
Principal Investigator: Sharon L.R. Kardia, PhD, University of Michigan, Ann Arbor, MI, USA MeSH: Hypertension,Aging,Arterial Pressure,Arteriosclerosis,Atherosclerosis,Biomarkers,Blood Pressure,Cardiovascular Diseases,Cholesterol,Cholesterol, HDL,Cholesterol, LDL,Coronary Artery Disease,Diabetes Mellitus,Echocardiography,Endophenotypes,Hyperglycemia,Hyperinsulinism,Hypertrophy, Left Ventricular,Inflammation,Kidney Failure, Chronic,Leukoaraiosis,Lipids,Obesity,Obesity, Abdominal,Peripheral Arterial Disease,Renal Insufficiency, Chronic,Triglycerides,Vascular Calcification https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001345 The Genetic Epidemiology Network of Arteriopathy (GENOA) is one of four networks in the NHLBI Family-Blood Pressure Program (FBPP). GENOA's long-term objective is to elucidate the genetics of target organ complications of hypertension, including both atherosclerotic and arteriolosclerotic complications involving the heart, brain, kidneys, and peripheral arteries. The longitudinal GENOA Study recruited European-American and African-American sibships with at least 2 individuals with clinically diagnosed essential hypertension before age 60 years. All other members of the sibship were invited to participate regardless of their hypertension status. Participants were diagnosed with hypertension if they had either 1) a previous clinical diagnosis of hypertension by a physician with current anti-hypertensive treatment, or 2) an average systolic blood pressure = 140 mm Hg or diastolic blood pressure = 90 mm Hg based on the second and third readings at the time of their clinic visit. Only participants of the African-American Cohort were sequenced through TOPMed. The Family Blood Pressure Program (FBPP), GENOA's parent program, is an unprecedented collaboration to identify genes influencing blood pressure (BP) levels, hypertension, and its target-organ damage. This program has conducted over 21,000 physical examinations, assembled a shared database of several hundred BP and hypertension-related phenotypic measurements, completed genome-wide linkage analyses for BP, hypertension, and hypertension associated risk factors and complications, and published over 130 manuscripts on program findings. The FBPP emerged from what was initially funded as four independent networks of investigators (HyperGEN, GenNet, SAPPHIRe and GENOA) competing to identify genetic determinants of hypertension in multiple ethnic groups. Realizing the greater likelihood of success through collaboration, the investigators created a single confederation with program-wide and network-specific goals. Comprehensive phenotypic data for GENOA study participants are available through dbGaP phs001238.

pht008602.v1.p1

1 Groupe Item 4 Eléments de données

pht008603.v1.p1

1 Groupe Item 2 Eléments de données

pht008604.v1.p1

1 Groupe Item 10 Eléments de données

dbGaP phs000703 CATHeterization GENetics (CATHGEN) - pht003668.v1.p1

- 10.01.23 - 6 Formulaires, 1 Groupe Item, 2 Eléments de données, 1 Langue
Groupe Item: pht003668
Principal Investigator: MeSH: Coronary Disease,Hypertension,Diabetes Mellitus,Heart Failure https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000703 The CATHGEN biorepository consists of biological samples collected on 9334 sequential consenting individuals undergoing cardiac catheterization at Duke University Medical Center between 2001 and 2010 inclusive. The Institutional Review Board informed consent allowed for 50 mL of blood to be collected from fasting patients through the femoral arterial sheath during the catheterization procedure. Three 7.5 mL EDTA tubes for DNA extraction are stored at -80°C. The Duke Database for Cardiovascular Disease (DDCD) provides the bulk of the clinical data used for analysis. Follow-up includes mortality information gleaned from the National Death Index and Social Security Death Index plus follow-up phone calls and written questionnaires regarding MI, stroke, re-hospitalization, coronary re-vascularization procedures, smoking, exercise, and medication use.

pht003670.v1.p1

1 Groupe Item 16 Eléments de données

pht003672.v1.p1

1 Groupe Item 15 Eléments de données

pht003673.v1.p1

1 Groupe Item 4 Eléments de données

pht003669.v1.p1

1 Groupe Item 5 Eléments de données

pht003671.v1.p1

1 Groupe Item 4 Eléments de données

dbGaP phs000309 The CARDIA-GENEVA Study - Eligibility

- 13.12.22 - 4 Formulaires, 1 Groupe Item, 1 Élément de données, 1 Langue
Groupe Item: IG.elig
Principal Investigator: Cora E. Lewis, MD, University of Alabama at Birmingham, Birmingham, AL, USA MeSH: Cardiovascular Diseases,Hypertension,Atherosclerosis,Obesity,Lipids,Diabetes Mellitus,Smoking,Pulmonary Function Test,Physical Activities,Energy Intake,Diet https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000309 *For the GENEVA CARDIA project, three genotype call sets were generated from a single set of array scans as a consequence of DNA sample quality problems. These call sets are designated "Birdsuite-1", "Birdsuite-2" and "Beaglecall". ("Beaglecall" used both Birdseed and BEAGLECALL calling algorithms.) An analysis-ready genotypic data set is provided in PLINK format for the "Beaglecall" set only, because it performs very well in QC analyses. Only raw CHP and ALLELE_SUMMARY files are provided for the two Birdsuite call sets because they have significant quality issues. Use of the Beaglecall set is highly recommended. Users of the other two call sets should proceed with caution. More details are given in the genotypic QC report.* The CARDIA study, sponsored by the National Heart, Lung and Blood Institute (NHLBI), is a prospective, multi-center investigation of the natural history and etiology of cardiovascular disease in African-Americans and Whites 18-30 years of age at the time of initial examination. The initial examination included 5,115 participants selectively recruited to represent proportionate racial, gender, age, and education groups from 4 communities: Birmingham, AL; Chicago, IL; Minneapolis, MN; and Oakland, CA. Participants from the Birmingham, Chicago, and Minneapolis centers were recruited from the total community or from selected census tracts. Participants from the Oakland center were randomly recruited from the Kaiser-Permanente health plan membership. From the time of initiation of the study in 1985-1986, five follow-up examinations have been conducted at years 2, 5, 7, 10, 15, and 20. The Year 25 examination is scheduled to begin in 2010. 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 associated with variation in longitudinal blood pressure profiles during the critical transition period from young adulthood to early middle-age; and to characterize their interactions with relevant environmental factors, such as body weight profiles. Genotyping was performed at the Broad Institute of MIT and Harvard, a GENEVA genotyping center. Data cleaning and harmonization were performed at the GEI-funded GENEVA Coordinating Center at the University of Washington.

pht001997.v2.p2

1 Groupe Item 4 Eléments de données

pht001999.v2.p2

1 Groupe Item 151 Eléments de données

pht001998.v2.p2

1 Groupe Item 4 Eléments de données

dbGaP phs000090 The Atherosclerosis Risk in Communities (ARIC) Study - pht001035.v1.p1

- 12.10.22 - 3 Formulaires, 1 Groupe Item, 4 Eléments de données, 1 Langue
Groupe Item: pht001035.v1.p1
https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000090 The Atherosclerosis Risk in Communities (ARIC) Study, sponsored by the National Heart, Lung and Blood Institute (NHLBI), is a prospective epidemiologic study conducted in four U.S. communities. The four communities are Forsyth County, NC; Jackson, MS; the northwest suburbs of Minneapolis, MN; and Washington County, MD. ARIC is designed to investigate the etiology and natural history of atherosclerosis, the etiology of clinical atherosclerotic diseases, and variation in cardiovascular risk factors, medical care and disease by race, gender, location, and date. ARIC includes two parts: the Cohort Component and the Community Surveillance Component. The Cohort Component began in 1987, and each ARIC field center randomly selected and recruited a cohort sample of approximately 4,000 individuals aged 45-64 from a defined population in their community. A total of 15,792 participants received an extensive examination, including medical, social, and demographic data. These participants were reexamined every three years with the first screen (baseline) occurring in 1987-89, the second in 1990-92, the third in 1993-95, and the fourth and last exam was in 1996-98. Follow-up occurs yearly by telephone to maintain contact with participants and to assess health status of the cohort. In the Community Surveillance Component, currently ongoing, these four communities are investigated to determine the community-wide occurrence of hospitalized myocardial infarction and coronary heart disease deaths in men and women aged 35-84 years. Hospitalized stroke is investigated in cohort participants only. Starting in 2006, the study conducts community surveillance of inpatient (ages 55 years and older) and outpatient heart failure (ages 65 years and older) for heart failure events beginning in 2005. ARIC is currently funded through January 31, 2012. 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 atherosclerosis and cardiovascular disease through large-scale genome-wide association studies of well-characterized cohorts of adults in four defined populations. Genotyping was performed at the Broad Institute of MIT and Harvard, a GENEVA genotyping center. Data cleaning and harmonization were done at the GEI-funded GENEVA Coordinating Center at the University of Washington.

pht000114.v1.p1

1 Groupe Item 362 Eléments de données

pht001036.v1.p1

1 Groupe Item 4 Eléments de données

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