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GSK 100262 Clinical Study Report Demography

- 17.05.17 - 1 Formular, 2 Itemgruppen, 4 Datenelemente, 1 Sprache
Itemgruppen: Date of assessment, Demography
GSK 100262 Clinical Study Report Demography

Study SHIP-START_SHIP3_INT_S3 - s3.f053_inan

- 26.10.24 - 219 Formulare, 1 Itemgruppe, 8 Datenelemente, 2 Sprachen
Itemgruppe: s3.f053_inan
SHIP Study https://doi.org/10.1093/ije/dyac034

s3.f049_inan

1 Itemgruppe 1 Datenelement

s3.f009_sozio

1 Itemgruppe 2 Datenelemente

s3.f076_khk

1 Itemgruppe 1 Datenelement

s3.f212_rau

1 Itemgruppe 6 Datenelemente

s3.f156

1 Itemgruppe 1 Datenelement

s3.f285

1 Itemgruppe 1 Datenelement

On-Study - Demo Enrollment - 2725838v1.0 - Demo Enrollment

- 17.09.21 - 1 Formular, 2 Itemgruppen, 9 Datenelemente, 1 Sprache
Itemgruppen: DEMOGRAPHY, HISTORY
Enrollment form Demo Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4508911E-AEC4-6A3B-E044-0003BA3F9857

Ewing Study Demographie DRKS00003588 - Demographie

- 04.08.14 - 1 Formular, 2 Itemgruppen, 7 Datenelemente, 2 Sprachen
Itemgruppen: Personal data, Identification numbers
EWING 2008, EudraCT 2008-003658-13, http://clinicaltrials.gov/ct2/show/NCT00824083 Prof. Dr. Heribert Jürgens, Prof. Dr. Uta Dirksen

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

- 29.01.25 - 6 Formulare, 1 Itemgruppe, 4 Datenelemente, 1 Sprache
Itemgruppe: 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 Itemgruppe 6 Datenelemente

pht002612.v2.p2

1 Itemgruppe 4 Datenelemente

pht002613.v2.p2

1 Itemgruppe 5 Datenelemente

pht002614.v2.p2

1 Itemgruppe 7 Datenelemente

pht005037.v1.p2

1 Itemgruppe 5 Datenelemente

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Demography

- 10.06.20 - 1 Formular, 3 Itemgruppen, 15 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Demography, Race
Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Demography Form has to be filled in at the Screening visit. Centre Number from Cover Sheets is included.

Demography GSK study Dyskinesia in Parkinson's disease NCT00363727

- 20.09.21 - 1 Formular, 2 Itemgruppen, 7 Datenelemente, 1 Sprache
Itemgruppen: General information, Demography
Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: Demography.

Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857 - RLS Demographics and Examination Procedure

- 20.02.18 - 1 Formular, 6 Itemgruppen, 18 Datenelemente, 1 Sprache
Itemgruppen: Demography, Vital signs, Orthostatic vital signs, Electrocardiogram (12 lead), Laboratory evaluation, Pregnancy Dipstick
Study ID: 101468/249 Clinical Study ID: 101468/249 Study Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome; Restless Legs Syndrome (RLS)

Demography GSK study Chronic Coronary Heart Disease NCT00799903

- 12.12.17 - 1 Formular, 1 Itemgruppe, 18 Datenelemente, 1 Sprache
Itemgruppe: Demography
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Demography

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Demography

- 04.12.20 - 1 Formular, 3 Itemgruppen, 17 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Randomization, Demography
The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out at the Screening Visit.

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Demography (Demographie)

- 23.03.20 - 1 Formular, 4 Itemgruppen, 14 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Demography, Ethnic group, Native language
DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the Demography form. It has to be filled in at the baseline of the study.

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Demography Data

- 30.04.20 - 1 Formular, 2 Itemgruppen, 8 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Demography
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

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