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NCI Standard Demography Template

- 20-09-21 - 1 Formulier, 3 Itemgroepen, 15 Data-elementen, 1 Taal
Itemgroepen: Demography, Demography, conditional, Demography, optional
The collection of CDEs used in the demography module. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=74E63D0F-0BF0-E8D1-E040-BB89AD430251

NINDS CDE Demographics Multiple Sclerosis - Demographics

- 15-03-21 - 1 Formulier, 1 Itemgroep, 8 Data-elementen, 1 Taal
Itemgroep: Demographics
NINDS Common Data Elements, Multiple Sclerosis Demographics Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

EHR4CR CTE Data Inventory

- 21-04-18 - 1 Formulier, 14 Itemgroepen, 133 Data-elementen, 1 Taal
Itemgroepen: Adverse Events, Concomitant Medication, Demographics, Disease Characteristics, Disposition, ECG, Laboratory, Laboratory Data, Medical History, Patient Reported Outcome, Substance Use, Surgery, Tumor Response, Vital Signs
Data Inventory for Clinical Trial Execution in the EHR4CR project. https://www.ncbi.nlm.nih.gov/pubmed/27875988 DOI for citation: 10.21961/MDM:17994

Demography Screening Ropinirole Parkinson Disease 101468/165 - Demography Screening

- 15-10-17 - 1 Formulier, 1 Itemgroep, 10 Data-elementen, 1 Taal
Itemgroep: Demography
Study Part: Demography Screening. An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

GSK 100262 Clinical Study Report Demography

- 17-05-17 - 1 Formulier, 2 Itemgroepen, 4 Data-elementen, 1 Taal
Itemgroepen: Date of assessment, Demography
GSK 100262 Clinical Study Report Demography

26672_Common Data Elements Myeloid Leukemia (MDS AML CML) - Global Disease Course

- 20-09-21 - 13 Formulieren, 3 Itemgroepen, 11 Data-elementen, 1 Taal
Itemgroepen: Global Disease Course, Red Cell Transfusion, Platelet Cell Transfusion
Common Data Elements Myeloid Leukemia (MDS, AML, CML) for use in clinical routine and clinical trial documentation. https://www.ncbi.nlm.nih.gov/pubmed/27577388

Physical Examination/Follow up

3 Itemgroepen 14 Data-elementen

Administrative/Demographic Details

1 Itemgroep 11 Data-elementen

Medical History

3 Itemgroepen 9 Data-elementen

Lab: Cytology/Cytogenetics/Cytochemistry

1 Itemgroep 29 Data-elementen

Lab: Immunophenotyping

1 Itemgroep 17 Data-elementen

Lab: Molecular Genetics

1 Itemgroep 27 Data-elementen

CDASH Demographics - Demographics

- 20-09-21 - 1 Formulier, 1 Itemgroep, 9 Data-elementen, 2 Talen
Itemgroep: Demographics
modified from http://www.cdisc.org

CDASH Subject Characteristics

- 20-06-18 - 1 Formulier, 1 Itemgroep, 5 Data-elementen, 2 Talen
Itemgroep: Subject Characteristics
modified from http://www.cdisc.org

CDASH Subject Characteristics - CDASH LAB (Scenario 2)

- 20-06-18 - 1 Formulier, 16 Itemgroepen, 95 Data-elementen, 1 Taal
Itemgroepen: LAB Information, CBC LAB Results – Leukocytes, CBC LAB Results – Neutrophils, CBC LAB Results – Lymphocytes, CBC LAB Results – Monocytes, CBC LAB Results – Eosinophils, CBC LAB Results – Basophils, CBC LAB Results – Erythrocytes, CBC LAB Results – Hemoglobin, CBC LAB Results – Hematocrit, CBC LAB Results - Platelet Count, CBC LAB Results - Ery. Mean Corpuscular Volume, CBC LAB Results - Mean Platelet Volume, CBC LAB Results - Ery. Mean Corpuscular Hemoglobin, CBC LAB Results - Ery. Mean Corpuscular HB Concentration, CBC LAB Results - Erythrocytes Distribution Width
modified from http://www.cdisc.org

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

- 29-01-25 - 6 Formulieren, 1 Itemgroep, 4 Data-elementen, 1 Taal
Itemgroep: 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 Itemgroep 6 Data-elementen

pht002612.v2.p2

1 Itemgroep 4 Data-elementen

pht002613.v2.p2

1 Itemgroep 5 Data-elementen

pht002614.v2.p2

1 Itemgroep 7 Data-elementen

pht005037.v1.p2

1 Itemgroep 5 Data-elementen

Study SHIP-START_SHIP3_INT_S3 - s3.f053_inan

- 26-10-24 - 219 Formulieren, 1 Itemgroep, 8 Data-elementen, 2 Talen
Itemgroep: s3.f053_inan
SHIP Study https://doi.org/10.1093/ije/dyac034

s3.f049_inan

1 Itemgroep 1 Data-element

s3.f009_sozio

1 Itemgroep 2 Data-elementen

s3.f076_khk

1 Itemgroep 1 Data-element

s3.f212_rau

1 Itemgroep 6 Data-elementen

s3.f156

1 Itemgroep 1 Data-element

s3.f285

1 Itemgroep 1 Data-element

Study_SHIP-TREND_TRV - t1.trv_soci_frm

- 26-10-24 - 35 Formulieren, 1 Itemgroep, 5 Data-elementen, 2 Talen
Itemgroep: t1.trv_soci_frm
SHIP Study https://doi.org/10.1093/ije/dyac034

t1.trv_inco_frm

1 Itemgroep 2 Data-elementen

t1.trv_inan_frm

1 Itemgroep 3 Data-elementen

t1.trv_thyr_frm

1 Itemgroep 3 Data-elementen

t1.trv_meta_frm

1 Itemgroep 5 Data-elementen

t1.trv_risk_frm

1 Itemgroep 7 Data-elementen

t1.trv_soma_frm

1 Itemgroep 7 Data-elementen

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