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

- 2023-12-01 - 4 Formulär, 1 Item-grupp, 1 Dataelement, 1 Språk
Item-grupp: 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.

pht004909.v3.p3

1 Item-grupp 2 Dataelement

pht004910.v4.p3

1 Item-grupp 2 Dataelement

pht004911.v3.p3

1 Item-grupp 9 Dataelement

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

- 2021-09-20 - 1 Formulär, 6 Item-grupper, 25 Dataelement, 1 Språk
Item-grupper: 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

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

- 2021-09-20 - 1 Formulär, 6 Item-grupper, 27 Dataelement, 1 Språk
Item-grupper: 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

Trial Medication Compliance PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

- 2021-09-20 - 1 Formulär, 4 Item-grupper, 17 Dataelement, 1 Språk
Item-grupper: Trial Medication Compliance, Blood Pressure Measurement, If Yes, Blood Pressure Measurement
The purpose of the trial is to determine if extended-release dipyridamole + aspirin [Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis, Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to placebo, in the presence of background antihypertensive therapy, in prevention of a second stroke in patients who have recently suffered a stroke and therefore are at high risk of suffering another one. Blood Pressure: Seated blood pressures will consist of the average of three consecutive measurements taken approximately two minutes apart, and round to the nearest whole numbers. When possible blood pressure should be taken using the automated device provided to the site by the sponsor. It is encouraged that the blood pressure is always taken in the sitting position, however for patient who cannot sit, supine bolded pressure is acceptable. Documentation process: This form ist to be obtained 7 days post-randomization at Visit 1A

dbGaP phs001293 NHLBI TOPMed: HyperGEN - Genetics of Left Ventricular (LV) Hypertrophy - Eligibility

- 2023-05-09 - 6 Formulär, 1 Item-grupp, 1 Dataelement, 1 Språk
Item-grupp: IG.elig
Principal Investigator: Donna K. Arnett, PhD, School of Public Health, University of Kentucky, Lexington, KY, USA MeSH: Hypertrophy, Left Ventricular,Antihypertensive Agents,Blood Pressure,Diastolic Pressure,Echocardiography,Heart Atria,Heart Ventricles,Hypertension,Stroke Volume,Systolic Pressure,Ventricular Dysfunction, Left,Ventricular Ejection Fraction,Ventricular Function, Left,Ventricular Remodeling https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001293 The Hypertension Genetic Epidemiology Network Study (HyperGEN) - Genetics of Left Ventricular (LV) Hypertrophy is a familial study aimed to understand genetic risk factors for LV hypertrophy by conducting genetic studies of continuous traits from echocardiography exams. The originating HyperGEN study aimed to understand genetic risk factors for hypertension. Data from detailed clinical exams as well as genotyping data for linkage studies, candidate gene studies and GWAS have been collected and is shared between HyperGEN and the ancillary HyperGEN - Genetics of LV Hypertrophy study.

pht008893.v1.p1

1 Item-grupp 5 Dataelement

pht008894.v1.p1

1 Item-grupp 6 Dataelement

pht008896.v1.p1

1 Item-grupp 142 Dataelement

pht008897.v1.p1

1 Item-grupp 9 Dataelement

pht008895.v1.p1

1 Item-grupp 2 Dataelement

GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586 - V6

- 2020-03-08 - 1 Formulär, 16 Item-grupper, 138 Dataelement, 1 Språk
Item-grupper: Date of visit, Experimental drug, Therapeutic procedure, Confirmation, Blood Pressure Monitoring, Ambulatory, Cognitive functions, Tests, Holter Electrocardiography, Holter Electrocardiography, Abnormality, Telemetry, Telemetry, Abnormality, Laboratory Procedures, Pulmonary function tests, Pharmacokinetic aspects, Blood, Pharmacokinetic aspects, Urine, Saliva specimen, Vital signs, Respiratory rate, Vital signs
Study ID: 110792 Clinical Study ID: 110792 Study Title: A placebo-controlled, single-blind, randomised study to investigate the safety, tolerability, pharmacokinetics and drug interaction of GSK1034702 after repeat doses in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950586 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Dextromethorphan, Placebo Trade Name: N/A Study Indication: Cognitive Disorders

GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586 - V5

- 2020-03-08 - 1 Formulär, 20 Item-grupper, 687 Dataelement, 1 Språk
Item-grupper: Date of visit, Experimental drug, Therapeutic procedure, Confirmation, Blood Pressure Monitoring, Ambulatory, Cognitive functions, Tests, Holter Electrocardiography, Holter Electrocardiography, Abnormality, Telemetry, Telemetry, Abnormality, Laboratory Procedures, Pulmonary function tests, Pharmacokinetic aspects, Blood, Saliva specimen, Vital signs, Vital signs, Vital signs, Vital signs, Vital signs, Vital signs, Vital signs, Respiratory rate
Study ID: 110792 Clinical Study ID: 110792 Study Title: A placebo-controlled, single-blind, randomised study to investigate the safety, tolerability, pharmacokinetics and drug interaction of GSK1034702 after repeat doses in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950586 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Dextromethorphan, Placebo Trade Name: N/A Study Indication: Cognitive Disorders

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

- 2023-03-05 - 4 Formulär, 1 Item-grupp, 6 Dataelement, 1 Språk
Item-grupp: 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 Item-grupp 4 Dataelement

pht008603.v1.p1

1 Item-grupp 2 Dataelement

pht008604.v1.p1

1 Item-grupp 10 Dataelement

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Visit 50: Physical Examination

- 2018-12-20 - 1 Formulär, 6 Item-grupper, 45 Dataelement, 1 Språk
Item-grupper: Administrative data, Vital Signs, General Physical Examination, General Medical History, Detailed Physical Examination, Assessment
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

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