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The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Pharmacogenetics - Pharmacogenetic Research Consent; Pharmacogenetics Research Withdrawal of Consent

- 06-05-19 - 1 Formulier, 2 Itemgroepen, 11 Data-elementen, 1 Taal
Itemgroepen: Pharmacogenetic Research Consent, Withdrawal of consent for PGx (DNA) sample destruction
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Logs/ Repeats - Logs and Repeats; Non- Serious Adverse Events; Serious Adverse Events; Concomitant Medication; Electronically Transferred Lab Data; Vital Signs; 12-Lead ECG; ECG Abnormalities; Repeat- Pharmacokinetics Blood - GW856553

- 01-05-19 - 1 Formulier, 16 Itemgroepen, 137 Data-elementen, 1 Taal
Itemgroepen: Logs ad Repeats, Logs and Repeats - Adverse event/ Concomitant Medication/ Repeat Assessment Check Questions, Non-serious Adverse Event (AE), Serious Adverse Events (SAE), Serious Adverse Event - Concomitant Medication, Serious Adverse Event - Medical Conditions/ Risk Factors, Serious Adverse Events - Relevant diagnostic results, Serious Adverse Events - Investigational Products, Serious Adverse Events - General narrative comments, Serious Adverse Events - Non clinical, Concomitant Medication, Electronically Transferred Lab Data, Vital signs, 12-Lead ECG, ECG Abnormalities, Repeat Pharmacokinetics Blood - GW856553
Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosi

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Follow-up - Electronically Transferred Lab Data; 12-Lead ECG; Vital Signs; Study Conclusion; Pregnancy Information

- 23-04-19 - 1 Formulier, 9 Itemgroepen, 40 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Electronically Transferred Lab Data - Pre dose, Electronically Transferred Lab Data - 24 hrs (Day 2), Electronically Transferred Lab Data - 72 hrs (Day 4) , 12-Lead ECG, Vital Signs, Study Conclusion, Pregnancy Information (F), Pregnancy Information (M)
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Period 1 - Randomisation Number; 12-Lead ECG; Vital Signs; Pharmacokinetics Blood GW856553; Electronically Transferred Lab Data; Investigational Product

- 23-04-19 - 1 Formulier, 17 Itemgroepen, 106 Data-elementen, 1 Taal
Itemgroepen: Randomisation Number, 12 Lead ECG - Dosing Date and Time, 12-Lead ECG - Pre-dose-measurement 1 (of 3) at least 5 minutes apart, 12-Lead ECG - Pre-dose-measurement 2 (of 3) at least 5 minutes apart , 12-Lead ECG - Pre-dose-measurement 3 (of 3) at least 5 minutes apart , 12-Lead ECG - 30 mins, 12-Lead ECG - 1 hr, 12-Lead ECG - 24 hr , Vital Signs, Vital Signs - Pre dose, Vital Signs - 30 mins, Vital Signs - 24 hrs, Pharmacokinetics Blood - GW856553, Electronically Transferred Lab Data - Pre dose, Electronically Transferred Lab Data - 24 hrs (Day 2), Electronically Transferred Lab Data - 72 hrs (Day 4) , Investigational Product
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Period 2 - 12-Lead ECG; Vital Signs; Pharmacokinetics Blood GW856553; Electronically Transferred Lab Data; Investigational Product

- 23-04-19 - 1 Formulier, 8 Itemgroepen, 50 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, 12-Lead ECG, Vital Signs, Pharmacokinetics Blood - GW856553, Electronically Transferred Lab Data - Pre dose, Electronically Transferred Lab Data - 24 hrs (Day 2), Electronically Transferred Lab Data - 72 hrs (Day 4) , Investigational Product
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Period 3 - 12-Lead ECG; Vital Signs; Pharmacokinetics Blood GW856553; Electronically Transferred Lab Data; Investigational Product

- 23-04-19 - 1 Formulier, 8 Itemgroepen, 50 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, 12-Lead ECG, Vital Signs, Pharmacokinetics Blood - GW856553, Electronically Transferred Lab Data - Pre dose, Electronically Transferred Lab Data - 24 hrs (Day 2), Electronically Transferred Lab Data - 72 hrs (Day 4) , Investigational Product
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Period 4 - 12-Lead ECG; Vital Signs; Pharmacokinetics Blood GW856553; Electronically Transferred Lab Data; Investigational Product

- 23-04-19 - 1 Formulier, 8 Itemgroepen, 50 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, 12-Lead ECG, Vital Signs, Pharmacokinetics Blood - GW856553, Electronically Transferred Lab Data - Pre dose, Electronically Transferred Lab Data - 24 hrs (Day 2), Electronically Transferred Lab Data - 72 hrs (Day 4) , Investigational Product
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Liver Event - Liver Events; Investigational Product; Pharmacokinetics; Medical Conditions; Alcohol Intake; Liver Imaging; Liver Biopsy

- 08-05-19 - 1 Formulier, 13 Itemgroepen, 104 Data-elementen, 1 Taal
Itemgroepen: Date of Visit, Liver Event Assessment, Liver Events, Investigational Product (Liver) - during treatment period, Investigational Product (Liver) - after treatment period , Pharmacokinetics (Liver PK), Medical Conditions (Liver), Drug related liver disease conditions, Other liver disease conditions, Other medical conditions, Alcohol intake, Liver imaging, Liver Biopsy
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Screen - Date of Visit; Demography, 12-Lead ECG; Vital Signs; Subject Identification; Electronically Transferred Lab Data

- 14-08-19 - 1 Formulier, 8 Itemgroepen, 34 Data-elementen, 1 Taal
Itemgroepen: Inform Screening, Subject number, Date of Visit/ Assessment, Demography, 12-Lead ECG, Vital Signs, Subject identification, Electronically Transferred Lab Data
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

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

- 01-12-23 - 4 Formulieren, 1 Itemgroep, 1 Data-element, 1 Taal
Itemgroep: 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 Itemgroep 2 Data-elementen

pht004910.v4.p3

1 Itemgroep 2 Data-elementen

pht004911.v3.p3

1 Itemgroep 9 Data-elementen

dbGaP phs000309 The CARDIA-GENEVA Study - Eligibility

- 13-12-22 - 4 Formulieren, 1 Itemgroep, 1 Data-element, 1 Taal
Itemgroep: IG.elig
Principal Investigator: Cora E. Lewis, MD, University of Alabama at Birmingham, Birmingham, AL, USA MeSH: Cardiovascular Diseases,Hypertension,Atherosclerosis,Obesity,Lipids,Diabetes Mellitus,Smoking,Pulmonary Function Test,Physical Activities,Energy Intake,Diet https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000309 *For the GENEVA CARDIA project, three genotype call sets were generated from a single set of array scans as a consequence of DNA sample quality problems. These call sets are designated "Birdsuite-1", "Birdsuite-2" and "Beaglecall". ("Beaglecall" used both Birdseed and BEAGLECALL calling algorithms.) An analysis-ready genotypic data set is provided in PLINK format for the "Beaglecall" set only, because it performs very well in QC analyses. Only raw CHP and ALLELE_SUMMARY files are provided for the two Birdsuite call sets because they have significant quality issues. Use of the Beaglecall set is highly recommended. Users of the other two call sets should proceed with caution. More details are given in the genotypic QC report.* The CARDIA study, sponsored by the National Heart, Lung and Blood Institute (NHLBI), is a prospective, multi-center investigation of the natural history and etiology of cardiovascular disease in African-Americans and Whites 18-30 years of age at the time of initial examination. The initial examination included 5,115 participants selectively recruited to represent proportionate racial, gender, age, and education groups from 4 communities: Birmingham, AL; Chicago, IL; Minneapolis, MN; and Oakland, CA. Participants from the Birmingham, Chicago, and Minneapolis centers were recruited from the total community or from selected census tracts. Participants from the Oakland center were randomly recruited from the Kaiser-Permanente health plan membership. From the time of initiation of the study in 1985-1986, five follow-up examinations have been conducted at years 2, 5, 7, 10, 15, and 20. The Year 25 examination is scheduled to begin in 2010. This study is part of the Gene Environment Association Studies initiative (GENEVA, http://www.genevastudy.org) funded by the trans-NIH Genes, Environment, and Health Initiative (GEI). The overarching goal is to identify novel genetic factors associated with variation in longitudinal blood pressure profiles during the critical transition period from young adulthood to early middle-age; and to characterize their interactions with relevant environmental factors, such as body weight profiles. Genotyping was performed at the Broad Institute of MIT and Harvard, a GENEVA genotyping center. Data cleaning and harmonization were performed at the GEI-funded GENEVA Coordinating Center at the University of Washington.

pht001997.v2.p2

1 Itemgroep 4 Data-elementen

pht001999.v2.p2

1 Itemgroep 151 Data-elementen

pht001998.v2.p2

1 Itemgroep 4 Data-elementen

dbGaP phs000090 The Atherosclerosis Risk in Communities (ARIC) Study - pht001035.v1.p1

- 12-10-22 - 3 Formulieren, 1 Itemgroep, 4 Data-elementen, 1 Taal
Itemgroep: pht001035.v1.p1
https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000090 The Atherosclerosis Risk in Communities (ARIC) Study, sponsored by the National Heart, Lung and Blood Institute (NHLBI), is a prospective epidemiologic study conducted in four U.S. communities. The four communities are Forsyth County, NC; Jackson, MS; the northwest suburbs of Minneapolis, MN; and Washington County, MD. ARIC is designed to investigate the etiology and natural history of atherosclerosis, the etiology of clinical atherosclerotic diseases, and variation in cardiovascular risk factors, medical care and disease by race, gender, location, and date. ARIC includes two parts: the Cohort Component and the Community Surveillance Component. The Cohort Component began in 1987, and each ARIC field center randomly selected and recruited a cohort sample of approximately 4,000 individuals aged 45-64 from a defined population in their community. A total of 15,792 participants received an extensive examination, including medical, social, and demographic data. These participants were reexamined every three years with the first screen (baseline) occurring in 1987-89, the second in 1990-92, the third in 1993-95, and the fourth and last exam was in 1996-98. Follow-up occurs yearly by telephone to maintain contact with participants and to assess health status of the cohort. In the Community Surveillance Component, currently ongoing, these four communities are investigated to determine the community-wide occurrence of hospitalized myocardial infarction and coronary heart disease deaths in men and women aged 35-84 years. Hospitalized stroke is investigated in cohort participants only. Starting in 2006, the study conducts community surveillance of inpatient (ages 55 years and older) and outpatient heart failure (ages 65 years and older) for heart failure events beginning in 2005. ARIC is currently funded through January 31, 2012. This study is part of the Gene Environment Association Studies initiative (GENEVA, http://www.genevastudy.org) funded by the trans-NIH Genes, Environment, and Health Initiative (GEI). The overarching goal is to identify novel genetic factors that contribute to atherosclerosis and cardiovascular disease through large-scale genome-wide association studies of well-characterized cohorts of adults in four defined populations. Genotyping was performed at the Broad Institute of MIT and Harvard, a GENEVA genotyping center. Data cleaning and harmonization were done at the GEI-funded GENEVA Coordinating Center at the University of Washington.

pht000114.v1.p1

1 Itemgroep 362 Data-elementen

pht001036.v1.p1

1 Itemgroep 4 Data-elementen

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