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  2. 2. Routine Documentation
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Screening - GSK Milveterol COPD 100527

- 9/20/21 - 1 form, 9 itemgroups, 132 items, 1 language
Itemgroups: Inclusion/Exclusion criteria, Demography, Duration of Asthma, Vital Signs, 12-Lead Electrocardiogram, Pulmonary function, Hematology, Clinical Chemistry, Urinalysis
Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

Eligibility NCT00525512 Pulmonary Disease, Chronic Obstructive - Eligibility

- 9/20/21 - 1 form, 2 itemgroups, 23 items, 2 languages
Itemgroups: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT00525512

dbGaP phs000946 NHLBI TOPMed: Boston Early-Onset COPD Study - Eligibility

- 11/27/24 - 5 forms, 2 itemgroups, 11 items, 1 language
Itemgroups: IG.0, IG.5
Principal Investigator: Edwin K. Silverman, Brigham and Women's Hospital Boston, MA USA MeSH: Chronic Obstructive Pulmonary Disease,Emphysema https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000946 Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in the United States and the only leading cause of death that is steadily increasing in frequency. This project collected a set of extended pedigrees ascertained through subjects with severe, early-onset COPD. This study has enrolled subjects with severe COPD (forced expiratory volume in one second (FEV1) 40% predicted) at an early age ( 53 years) without alpha-1 antitrypsin deficiency (a known Mendelian risk factor for COPD). Extended pedigrees are enrolled, primarily in New England, although some more geographically distant subjects have been included. This study has been used for epidemiological studies, familial aggregation analysis, linkage analysis, and candidate gene association analysis. Approximately 80 of the severe, early-onset COPD probands will undergo whole genome sequencing in this project with sequencing data available through dbGaP.

pht004972.v3.p1

1 itemgroup 2 items

pht004973.v3.p1

1 itemgroup 2 items

pht004974.v2.p1

1 itemgroup 9 items

pht005719.v2.p1

1 itemgroup 15 items

dbGaP phs000951 NHLBI TOPMed: Genetic Epidemiology of COPD (COPDGene) - pht005050.v5.p5

- 1/30/24 - 4 forms, 1 itemgroup, 3 items, 1 language
Itemgroup: pht005050
Principal Investigator: James D. Crapo, National Jewish Health, Denver, CO, USA MeSH: Pulmonary Disease, Chronic Obstructive,Emphysema https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000951 Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in the United States, and the only leading cause of death that is steadily increasing in frequency. This project established a racially diverse cohort that is sufficiently large and appropriately designed for genome-wide association analysis of COPD. A total of 10,720 subjects were recruited, including control smokers and nonsmokers, definite COPD cases (GOLD Stage 2 to 4), and subjects not included in either group (GOLD 1 and PRISm). This cohort is being used for cross-sectional analysis, and long-term longitudinal follow-up visits after five years and after ten years are also being performed. The primary focus of the study is to identify the genetic risk factors that determine susceptibility for COPD and COPD-related phenotypes. Detailed phenotyping of both cases and controls, including chest CT scan assessment of emphysema and airway disease, will allow identification of genetic determinants for the heterogeneous components of the COPD syndrome. The aims for this study are: - Precise phenotypic characterization of COPD subjects using computed tomography, as well as clinical and physiological measures, that will provide data to enable the broad COPD syndrome to be decomposed into clinically significant subtype; - Genome-wide association studies will identify genetic determinants for COPD susceptibility that will provide insight into clinically relevant COPD subtypes; - Distinct genetic determinants influence the development of emphysema and airway disease. The TOPMed analysis will include approximately 10,500 subjects with whole genome sequencing after quality control is completed. Comprehensive phenotypic data for COPDGene subjects is available through dbGaP study phs000179.

pht005051.v5.p5

1 itemgroup 2 items

pht005052.v5.p5

1 itemgroup 10 items

Eligibility

1 itemgroup 47 items

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

- 12/1/23 - 4 forms, 1 itemgroup, 1 item, 1 language
Itemgroup: 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 itemgroup 2 items

pht004910.v4.p3

1 itemgroup 2 items

pht004911.v3.p3

1 itemgroup 9 items

dbGaP phs000624 The Lung Genomics Research Consortium (LGRC) - Eligibility

- 1/9/23 - 5 forms, 1 itemgroup, 1 item, 1 language
Itemgroup: IG.elig
Principal Investigator: David Schwartz, MD, University of Colorado, Denver, USA MeSH: Pulmonary Disease, Chronic Obstructive,Lung Diseases, Interstitial,Pulmonary Emphysema https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000624 Chronic lung diseases represent a broad spectrum of chronic fibrosing/inflammatory lung conditions that are for the most part poorly responsive to treatment and often fatal. COPD/emphysema is the fourth leading cause of death in the United States and the incidence and rate of death from pulmonary fibrosis is increasing each year. Although progress has been made in interpretation of the clinical, radiological, and pathological features of chronic lung disorders, and progress in determining the pathobiology continues, the causes, biologic mechanisms, and therapeutic options remain obscure. Moreover, predicting individuals or populations at risk for developing any of these complex diseases, at present, is not possible. To address this challenge, we plan to create a genetic, molecular, and quantitative clinical phenotyping data warehouse with bioinformatic tools that will empower investigators to make fundamental discoveries in disease pathogenesis, refine diagnostic criteria, and lead to real gains in personalized medicine. The composite genetic, genomic, and epigenetic signature combined with quantitative clinical phenotypes has the potential to characterize the dynamic biological state of a complex disease and complement existing diagnostic approaches that are reliant on traditional clinical measures of disease. In the proposed project, we plan to extend the scope and impact of the NHLBI Lung Tissue Research Consortium (LTRC) biorepository by creating the Lung Genomics Research Consortium (LGRC), a comprehensive genetic, molecular, and quantitative clinical phenotyping warehouse. *Our overall hypothesis is that a genetic, molecular, and quantitative clinical phenotyping warehouse combined with a rich clinical database will enable the lung research community to make fundamental discoveries in disease pathogenesis, refine diagnostic criteria, and lead to real gains in personalized medicine.* We plan to pursue this hypothesis through the following aims. *Specific Aim 1: *Establish a genetic, genomic, and epigenetic molecular library to complement the existing clinical database in the LTRC. *Specific Aim 2: *Develop a quantitative clinical phenotyping platform using existing LTRC data, as well as an enhanced data set including novel quantitative CT and histology imaging analyses. *Specific Aim 3: *Establish a publicly-accessible database that would integrate the genetic, molecular, and quantitative phenotyping data with the existing clinical data in the LTRC and provide query and data exploration tools that are easily accessible to the lung research community. These discoveries will enable clinicians to- Identify individuals at risk of developing chronic lung diseases; - Diagnose these conditions earlier; - Identify novel mechanisms that cause these diseases; - Reclassify disease entities into categories more representative of molecular and cellular pathogenic mechanisms regardless of traditional disease categories; - develop personalized approaches to treatment.

pht009129.v1.p1

1 itemgroup 2 items

pht009130.v1.p1

1 itemgroup 2 items

pht009131.v1.p1

1 itemgroup 14 items

pht009132.v1.p1

1 itemgroup 6 items

Tele-yoga Program in COPD and Heart Failure (Tele-Yoga) NCT02078739 - Eligibility Tele-Yoga NCT02078739

- 11/18/21 - 1 form, 2 itemgroups, 16 items, 2 languages
Itemgroups: Inclusion Criteria, Exclusion Criteria
A controlled, non-randomised trial was conducted of an 8-week Tele-Yoga intervention versus an educationalcontrol (information leaflets mailed to participants with one phone call a week). Biweekly one-hour Tele-Yoga classeswere implemented via multipoint videoconferencing that connected participants to live classes via an Internet connectionto their televisions. Semi-structured qualitative interviews were conducted with participants post study exit to explorereasons for and experiences of participating, including views of study outcome measures and physiologicaltests. Transcribed interviews were analysed using thematic content analysis.

Eligibility Chronic Obstructive Pulmonary Disease NCT00981851

- 9/20/21 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Interaction in Chronic Obstructive Pulmonary Disease Experiment; ODM derived from: https://clinicaltrials.gov/show/NCT00981851

Follow-up - GSK Milveterol COPD 100527

- 9/20/21 - 1 form, 5 itemgroups, 42 items, 1 language
Itemgroups: Vital Signs Follow-up, 12-Lead Electrocardiogram Follow-up, Hematology Follow-up, Clinical chemistry Follow-up, Urinalysis Follow-up
Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

Electrocardiogram Abnormalities Form - GSK Milveterol COPD 100527

- 9/20/21 - 1 form, 1 itemgroup, 11 items, 1 language
Itemgroup: Electrocardiogram Abnormalities
Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

Main CRF (Treatment Period 1, Day 1-2) - GSK Milveterol COPD 100527

- 9/20/21 - 1 form, 16 itemgroups, 123 items, 1 language
Itemgroups: Investigational Product Day 1, Investigational Product Day 2, Hematology Day 1 Pre-Dose, Clinical chemistry Day 1 Pre-Dose, Urinalysis Day 1 Pre-Dose, Vital Signs Day 1, Vital Signs Day 2, 12-Lead Electrocardiogram Day 1, 12-Lead Electrocardiogram Day 2, FEV1 Day 1, Pharmacokinetic sampling Day 1, Potassium and Glucose Day 1, Pharmacokinetic Urine lnterval Collection Data Day 1, Hematology Day 1 Post-Dose, Clinical chemistry Day 1 Post-Dose, Urinalysis Day 1 Post-Dose
Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

Main CRF (Treatment Period 3, Day 1-2) - GSK Milveterol COPD 100527

- 9/20/21 - 1 form, 16 itemgroups, 123 items, 1 language
Itemgroups: Investigational Product Day 1, Investigational Product Day 2, Hematology Day 1 Pre-Dose, Clinical chemistry Day 1 Pre-Dose, Urinalysis Day 1 Pre-Dose, Vital Signs Day 1, Vital Signs Day 2, 12-Lead Electrocardiogram Day 1, 12-Lead Electrocardiogram Day 2, FEV1 Day 1, Pharmacokinetic sampling Day 1, Potassium and Glucose Day 1, Pharmacokinetic Urine lnterval Collection Data Day 1, Hematology Day 1 Post-Dose, Clinical chemistry Day 1 Post-Dose, Urinalysis Day 1 Post-Dose
Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

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