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dbGaP phs000309 The CARDIA-GENEVA Study - Eligibility

- 12/13/22 - 4 forms, 1 itemgroup, 1 item, 1 language
Itemgroup: 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 itemgroup 4 items

pht001999.v2.p2

1 itemgroup 151 items

pht001998.v2.p2

1 itemgroup 4 items

Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI) NCT00669760- Outpatient Department Visit 1-8

- 9/20/21 - 1 form, 10 itemgroups, 72 items, 2 languages
Itemgroups: Outpatient Department, Disease, vital signs; lung function, Clinical status, Antibiotics, Azithromycin, therapy, antibiotics, inhaled, Antibiotics, Specimen Collection, Dispatch
Study documentation part: Outpatient Department Visit 1 - 8. Dissection of staphylococcus aureus infection from colonization in cystic fibrosis patients, a non-interventional, prospective, longitudinal multicenter study. Trial number: NCT00669760.

Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI) NCT00669760- Outpatient Department Visit (Undefined)

- 9/20/21 - 4 forms, 10 itemgroups, 72 items, 2 languages
Itemgroups: Outpatient Department, Disease, vital signs; lung function, Clinical status, Antibiotics, Azithromycin, therapy, antibiotics, inhaled, Antibiotics, Specimen Collection, Dispatch
Study documentation part: Outpatient Department Visit (Undefined and with microbiology part). Dissection of staphylococcus aureus infection from colonization in cystic fibrosis patients, a non-interventional, prospective, longitudinal multicenter study. Trial number: NCT00669760.

Microbiology- Staphylococcus aureus characteristics

5 itemgroups 29 items

Microbiology- Summary sheet

4 itemgroups 23 items

Microbiology- Sputum, Serum and EDTA blood

3 itemgroups 13 items

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - Pulmonary function test

- 2/28/20 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Administrative data, Pulmonary function test
Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the pulmonary function test. It has to be filled in for screening, V2b, V3, V5, follow-up and if required for logs/ repeats.

Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI) NCT00669760 – (Patient Log)

- 11/2/15 - 1 form, 1 itemgroup, 10 items, 2 languages
Itemgroup: Patient Log
Study documentation part: (Patient Log). Dissection of staphylococcus aureus infection from colonization in cystic fibrosis patients, a non-interventional, prospective, longitudinal multicenter study. Trial number: NCT00669760.

Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI) NCT00669760 – (Centre-Log)

- 11/2/15 - 1 form, 1 itemgroup, 9 items, 2 languages
Itemgroup: Centre-Log
Study documentation part: (Centre-Log). Dissection of staphylococcus aureus infection from colonization in cystic fibrosis patients, a non-interventional, prospective, longitudinal multicenter study. Trial number: NCT00669760.

Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI) NCT00669760 Basic Data - Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI) NCT00669760 <e2><80><93> Basic Data

- 11/1/15 - 1 form, 4 itemgroups, 12 items, 2 languages
Itemgroups: Basic data, Inclusion Criteria, Exclusion Criteria, Demography
Study documentation part: Basic Data. Dissection of staphylococcus aureus infection from colonization in cystic fibrosis patients, a non-interventional, prospective, longitudinal multicenter study. Trial number: NCT00669760.

dbGaP phs000397 NIA Long Life Family Study (LLFS) - Eligibility

- 10/12/22 - 6 forms, 1 itemgroup, 3 items, 1 language
Itemgroup: IG.elig
Principal Investigator: Michael A. Province, PhD, Washington University School of Medicine, St. Louis, MO, USA MeSH: Longevity,Aging,Cardiovascular Diseases,Neoplasms,Stroke,Inflammation,Immune System,Diabetes Mellitus,Hypertension,Dyslipidemias,Lipids,Osteoporosis,Pulmonary Function Tests,Kidney Function Tests,Alzheimer Disease,Depression,Personality,Executive Function,Reproductive History https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000397 The Long Life Family Study (LLFS) is an international collaborative study of the genetics and familial components of exceptional survival, longevity, and healthy aging. Families were recruited through elderly probands (generally in their 90s) who self-reported on the survival history of their parents and siblings, and on the basis of this information, families which showed clustering of exceptional survival were recruited. [Specifically, a Family Longevity Selection Score (FLOSS) ≥7 was required. The FLOSS measures the average excess Observed lifespan over that Expected based upon lifetables, while adding a bonus term for still-living individuals. Thus FLOSS is a useful tool for scoring and selecting families for inclusion in a research study of exceptional survival (Sebastiani et al., 2009, PMID: 19910380)]. Probands resided in the catchment areas of four Field Centers (Boston University, Columbia University, University of Pittsburgh, and University of Southern Denmark). Recruited family members were phenotyped through extensive in-home visits by teams of technicians who traveled all over the USA and Denmark. Blood assays were centrally processed at a Laboratory Core (University of Minnesota) and protocols were standardized, monitored and coordinated through a Data Management Coordinating Center (Washington University). We examined and extensively phenotyped in all major domains of healthy aging, 4,953 individuals in 539 families through comprehensive in-home visits. Of these, 4,815 gave dbGaP sharing permission and had sufficient quantity/quality of DNA for GWAS genotyping. This large collection of families, selected on the basis of clustering for exceptional survival, is a unique resource for the study of human longevity and healthy aging. We estimate that less than 1% of the Framingham Heart Study (FHS) families (a roughly random population family sample) would meet the minimal entrance criteria for exceptional survival required in the LLFS (Sebastiani et al., 2009, PMID: 19910380). Thus, the least exceptional LLFS families show more clustering for exceptional longevity than 99% of the FHS families. Although the LLFS pedigrees were selected on the basis of longevity per se in the upper generation (and the generation above that), the children's generation have significantly lower rates of many major diseases and have better healthy aging profiles for many disease phenotypes (Newman et al., 2011, PMID: 21258136). The participants had their first in-person visit between 2006 and 2009. After that visit, they were contacted annually by telephone to update vital status, medical history, and general health. Between 2014 and 2017, willing participants completed a second in-person visit. The second visit followed the same protocols and centralized training as the first visit. During the second visit, a portable carotid ultrasound exam was added. Again, participants were continuously contacted annually for telephone follow-up during the period of the second in-person visit and after that. Annual telephone follow-ups currently ongoing, and plans for a third in-person visit are in progress.

pht002407.v3.p3

1 itemgroup 4 items

pht002408.v3.p3

1 itemgroup 6 items

pht002410.v3.p3

1 itemgroup 106 items

pht003356.v3.p3

1 itemgroup 4 items

pht002409.v3.p3

1 itemgroup 3 items

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