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Swedish Stroke Registry RIKSSTROKE - TIA

- 29.11.17 - 1 Formular, 7 Itemgruppen, 67 Datenelemente, 2 Sprachen

Itemgruppen: TIA - Patient Information, Sequence of care, Risk Factors TIA, Acute Care/Diagnosis TIA, Pharmaceutical Treatment, Information and Follow-up, ABCD2 score

Schwedisches Schlaganfallregister RIKSSTROKE Quelle: http://www.riksstroke.org/eng/ Riksstroke – a Swedish national quality register for stroke care primarily aimed at health professionals and decision makers in health care. We collect, analyze and follow-up data on morbidity and hospital stay. TIA

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Immune Mediated Disease Report; General Medical History; Relevant Risk Factors; Neurological Events; Myasthenia Gravis; Uveitis (Report Final and Annex Report 2 Final)

- 02.11.20 - 1 Formular, 31 Itemgruppen, 114 Datenelemente, 1 Sprache

Itemgruppen: Administrative, IMD Report, General Medical History, General Medical History , Relevant risk factors, Neurological Events, Neurological Events - Signs and Symptoms, Neurological Events - Signs and Symptoms - Seizures, Neurological Events - Signs and Symptoms, Neurological Events - Other signs and symptoms, Neurological Events - Other signs and symptoms , Neurological Events - Diagnostic Test Results, Neurological Events - Other Diagnostic Test Results , Neurological Events - Other Diagnostic Test Results , Neurological Events - Other diagnostic Procedure, Myasthenia Gravis, Myasthenia Gravis - Signs and symptoms (supporting the final diagnosis), Myasthenia Gravis - Other Signs and symptoms, Myasthenia Gravis - Other Signs and symptoms , Myasthenia Gravis - Diagnostic Test Results, Myasthenia Gravis - Other Diagnostic Test Results , Myasthenia Gravis - Other Diagnostic Test Results , Myasthenia Gravis - Other diagnostic Procedure , Uveitis, Uveitis - Signs and symptoms (supporting the final diagnosis), Uveitis - Other Signs and symptoms , Uveitis - Other Signs and symptoms , Uveitis - Diagnostic Test Results , Uveitis - Other Diagnostic Test Results , Uveitis - Other Diagnostic Test Results , Uveitis - Other diagnostic Procedure

Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

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

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GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Ocular History and Risk Factors

- 12.12.20 - 1 Formular, 3 Itemgruppen, 17 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, ocular history and risk factors, cataract risk factors

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, a follow-up visit, a logs and repeats visit, a PGx visit and a visit for the common CRF. 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.

Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration NCT01134055 - Screen - Medical / surgical procedures; Risk Factors; Vital Signs; History of Tobacco Use; Alcohol intake

- 10.01.20 - 1 Formular, 10 Itemgruppen, 31 Datenelemente, 1 Sprache

Itemgruppen: Medical/ surgical procedures - Right Eye, Medical/ surgical procedures - Left Eye , Other ocular surgeries and procedures, Risk Factors, Vital Signs, First sitting BP reading, Second sitting BP reading , Third sitting BP reading , History of Tobacco Use, Alcohol intake

Study ID: 110852 Clinical Study ID: 110852 Study Title: MD7110852, A Phase 2b Dose-Ranging Study of Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01134055 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib eye drops, ranibizumab intravitreal injection, placebo Trade Name: pazopanib, ranibizumab Study Indication: Macular Degeneration

dbGaP phs000974 NHLBI TOPMed: Whole Genome Sequencing and Related Phenotypes in the Framingham Heart Study - Eligibility

- 01.12.23 - 4 Formulare, 1 Itemgruppe, 1 Datenelement, 1 Sprache

Itemgruppe: IG.elig

Principal Investigator: Vasan Ramachandran, Department of Medicine, Boston University School of Medicine, Boston, MA, USA MeSH: Cardiovascular Diseases,Atherosclerosis,Atrial Fibrillation,Death, Sudden, Cardiac,Diabetes Mellitus, Type 2,Heart Failure,Blood Pressure,Hypertension,Body Mass Index,Adiposity,Lipids,Pulmonary Disease, Chronic Obstructive,Renal Insufficiency, Chronic,Stroke,Osteoporosis,Risk Factors,Biological Markers,Biomarkers, Pharmacological https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000974 The Framingham Heart Study (FHS) is a prospective cohort study of 3 generations of subjects who have been followed up to 65 years to evaluate risk factors for cardiovascular disease. Its large sample of ~15,000 men and women who have been extensively phenotyped with repeated examinations make it ideal for the study of genetic associations with cardiovascular disease risk factors and outcomes. DNA samples have been collected and immortalized since the mid-1990s and are available on ~8000 study participants in 1037 families. These samples have been used for collection of GWAS array data and exome chip data in nearly all with DNA samples, and for targeted sequencing, deep exome sequencing and light coverage whole genome sequencing in limited numbers. Additionally, mRNA and miRNA expression data, DNA methylation data, metabolomics and other 'omics data are available on a sizable portion of study participants. This project will focus on deep whole genome sequencing (mean 30X coverage) in ~4100 subjects and imputed to all with GWAS array data to more fully understand the genetic contributions to cardiovascular, lung, blood and sleep disorders. Comprehensive phenotypic and pedigree data for study participants are available through dbGaP phs000007.

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*

GSK Study to Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib in Healthy Subjects 102587 - Serious Adverse Event, Relevant Concomitant Treatment/Medications/Results

- 24.04.18 - 1 Formular, 3 Itemgruppen, 26 Datenelemente, 1 Sprache

Itemgruppen: Relevant concomitant/treatment medications, Relevant medical conditions/Risk factors, Relevant diagnostic results

Study ID: 102587 Clinical Study ID: EGF102587 Study Title: A Single-Dose, Open-Label, Randomized, Three-Way Cross-Over Study in Healthy Subjects to Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib (GW572016) Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tykerb,Tycerb,Tyverb; Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Breast Documentation part: Serious Adverse Event, Relevant Concomitant Treatment/Medications/Results

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Swedish Stroke Registry RIKSSTROKE - TIA

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Immune Mediated Disease Report; General Medical History; Relevant Risk Factors; Neurological Events; Myasthenia Gravis; Uveitis (Report Final and Annex Report 2 Final)

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

Eligibility

pht002612.v2.p2

pht002613.v2.p2

pht002614.v2.p2

pht005037.v1.p2

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Ocular History and Risk Factors

Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration NCT01134055 - Screen - Medical / surgical procedures; Risk Factors; Vital Signs; History of Tobacco Use; Alcohol intake

dbGaP phs000974 NHLBI TOPMed: Whole Genome Sequencing and Related Phenotypes in the Framingham Heart Study - Eligibility

pht004909.v3.p3

pht004910.v4.p3

pht004911.v3.p3

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

pht008249.v1.p1

pht008245.v1.p1

pht008246.v1.p1

pht008247.v1.p1

pht008248.v1.p1

GSK Study to Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib in Healthy Subjects 102587 - Serious Adverse Event, Relevant Concomitant Treatment/Medications/Results

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