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

- 29/01/2025 - 6 moduli, 1 ItemGroup, 4 elementi, 1 linguaggio

ItemGroup: 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.

dbGaP phs001367 Add Health: The National Longitudinal Study of Adolescent to Adult Health (Add Health) - Eligibility

- 25/02/2023 - 6 moduli, 1 ItemGroup, 11 elementi, 1 linguaggio

ItemGroup: IG.elig

Principal Investigator: Kathleen Mullan Harris, PhD, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA MeSH: Adolescent Health,National Longitudinal Study of Adolescent Health,Obesity,Body Weight,Cholesterol,C-Reactive Protein,Depression,Alcohol Drinking,Smoking,Personality,Life Style,Ethnic Groups,Health Status,Population Groups,Housing,Socioeconomic Factors,Educational Status,Employment,Family Characteristics,Income,Occupations,Poverty,Risk Factors https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001367 The National Longitudinal Study of Adolescent to Adult Health [Add Health] is an ongoing longitudinal study of a nationally representative U.S. cohort of more than 20,000 adolescents in grades 7-12 (aged 12-19 years) in 1994 followed into adulthood with five interviews/surveys in 1995, 1996, 2001-02, 2008, and 2016-18. Add Health was designed to understand how social environments and behaviors in adolescence are linked to health and achievement outcomes in young adulthood. Add Health contains unprecedented environmental, behavioral, psychosocial, biological, and genetic data from early adolescence and into adulthood on a large, nationally representative cohort with unprecedented racial, ethnic, socioeconomic, and geographic diversity. Add Health has a large, multidisciplinary user base of over 50,000 researchers around the world who have published over 3,400 research articles. Add Health is housed at the Carolina Population Center of the University of North Carolina at Chapel Hill. Add Health datasets are distributed according to a tiered data disclosure plan designed to protect the data from the risk of direct and indirect disclosure of respondent identity. Add Health's large sample size, population diversity and rich longitudinal data base of psychosocial, physical, and contextual data will permit investigation of an exceptionally broad range of phenotypes with known genetic variation. Prospective longitudinal measures are available to document change over time in each of these phenotypes, as well as change in the social environment and life experiences, making the Add Health sample ideal for understanding genetic linkages with health and behavior across the life course. The original design of Add Health included important features for understanding biological processes in health and developmental trajectories across the life course of young people, including an embedded genetic sample with more than 3,000 pairs of adolescents with varying biological resemblance (e.g., twins, full sibs, half sibs, and adolescents who grew up in the same household but have no biological relationship), testing of saliva and urine for sexually transmitted infections and HIV, and biomarkers of cardiovascular health, metabolic processes, immune function, renal function, and inflammation. Add Health therefore has critical objective indicators of health status and disease markers in young adulthood, well before chronic illness or its complications emerge in later adulthood. Because DNA has been collected on the full sample at Wave IV, it is possible to link genetic profiles with social, behavioral, and biological measures over time from adolescence into adulthood. Add Health sampled the multiple environments in which young people live their lives, including the family, peers, school, neighborhood, community, and relationship dyads, and provides independent and direct measurement of these environments over time. Add Health contains extensive longitudinal information on health-related behavior, including life histories of physical activity, involvement in risk behavior, substance use, sexual behavior, civic engagement, education, and multiple indicators of health status based on self-report (e.g., general health, chronic illness), direct measurement (e.g., overweight status and obesity), and biomarkers. No other data resource with this expanse of genotype and phenotype data on a large nationally representative longitudinal sample with race, ethnic, socioeconomic, and geographic diversity exists. A complete reference guide on study design and accomplishments can be found on the Add Health website: Design Paper: *The Add Health Study: Design and Accomplishments Kathleen Mullan Harris Carolina Population Center University of North Carolina at Chapel Hill 2013*

Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218 - Dose Level 1, Day1, Pre-dose - Prior Medication; Pregnancy Test; Alcohol Breath Test; Drug Screening (Urine); Vital Signs

- 20/09/2021 - 1 modulo, 7 itemgroups, 31 elementi, 1 linguaggio

Itemgroups: Administrative, Prior Medication, Prior Medication , Pregnancy Test, Alcohol Breath Test, Drug Screening (Urine) , Vital Signs

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636 - Subject at Home Diary - Baseline

- 20/09/2021 - 1 modulo, 6 itemgroups, 27 elementi, 1 linguaggio

Itemgroups: Administrative documentation, Blood Pressure, Exercise, Information, Pharmaceutical Preparations, Subject Diary, Alcohol consumption, Subject Diary, Caffeine Use, Subject Diary, Tobacco Use, Subject Diary

Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636 - Subject In-Clinic Diary - Screen

- 20/09/2021 - 1 modulo, 6 itemgroups, 25 elementi, 1 linguaggio

Itemgroups: Administrative documentation, Pharmaceutical Preparations, Subject Diary, Blood Pressure, Exercise, Migraine Disorders, Information, Alcohol consumption, Subject Diary, Caffeine Use, Subject Diary, Tobacco Use, Subject Diary

Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Screening - Alcohol Intake; Alcohol Breath Test; Urine Test for Drugs of Abuse; Urine Cotinine Test; History of Tobacco Use

- 07/01/2021 - 1 modulo, 7 itemgroups, 14 elementi, 1 linguaggio

Itemgroups: Administrative, Alcohol Intake, Alcohol Breath Test, Urine Test for Drugs of Abuse, Urine Test for Drugs of Abuse , Urine Cotinine Test, History of Tobacco Use

Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471) - Drug and Alcohol Screen; Laboratory Result Data; Urinalysis

- 03/07/2020 - 1 modulo, 10 itemgroups, 17 elementi, 1 linguaggio

Itemgroups: Administrative, Drug and alcohol screen, Drug and alcohol screen , Laboratory Result Data (Haematology), Laboratory Result Data (Haematology) , Laboratory Result Data (Clinical Chemistry), Laboratory Result Data (Clinical Chemistry) , Urinalysis, Urinalysis (Dipstick) Test, Urinalysis (Microscopy) Test

Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471) - Screening - Demography; Medical Conditions; Alcohol Intake; History of Tobacco Use; Serology

- 26/06/2020 - 1 modulo, 6 itemgroups, 17 elementi, 1 linguaggio

Itemgroups: Administrative, Demography, Medical Conditions, Alcohol intake, History of Tobacco Use, Serology

Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Urine Drug and Alcohol Screen

- 12/06/2020 - 1 modulo, 2 itemgroups, 11 elementi, 1 linguaggio

Itemgroups: Administrative, Urine Drug and Alcohol Screen

Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Screening - Demography; Medical Conditions; Alcohol Intake; History of Tobacco Use

- 12/06/2020 - 1 modulo, 5 itemgroups, 15 elementi, 1 linguaggio

Itemgroups: Administrative, Demography, Medical Conditions, Alcohol intake, History of Tobacco Use

Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Drug Screen, Alcohol Breath Test

- 15/05/2020 - 1 modulo, 3 itemgroups, 14 elementi, 1 linguaggio

Itemgroups: Administrative Data, Drug Screening, Alcohol Breath Test

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 Drug Screening and Alcohol Breath Test form has to be filled in at screening and at both pre-dose treatment examinations.

Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218 - Alcohol Breath Test, Randomisation, Drug Screening

- 05/05/2020 - 1 modulo, 4 itemgroups, 12 elementi, 1 linguaggio

Itemgroups: Administrative, Alcohol Breath Test, Randomisation, Drug Screening (Urine)

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

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

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dbGaP phs001367 Add Health: The National Longitudinal Study of Adolescent to Adult Health (Add Health) - Eligibility

pht008249.v1.p1

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