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dbGaP phs000309 The CARDIA-GENEVA Study - Eligibility

- 13/12/2022 - 4 Formulários, 1 Grupo de itens, 1 Elemento de dados, 1 Idioma
Grupo de itens: 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 Grupo de itens 4 Elementos de dados

pht001999.v2.p2

1 Grupo de itens 151 Elementos de dados

pht001998.v2.p2

1 Grupo de itens 4 Elementos de dados

dbGaP phs000422 NHLBI GO-ESP: Lung Cohorts Exome Sequencing Project (Asthma) - Eligibility

- 12/10/2022 - 5 Formulários, 1 Grupo de itens, 1 Elemento de dados, 1 Idioma
Grupo de itens: IG.elig
Principal Investigator: Deborah A. Meyers, PhD, Wake Forest School of Medicine, Winston-Salem, NC, USA MeSH: Asthma,Respiratory Function Tests https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000422 The NHLBI "Grand Opportunity" Exome Sequencing Project (GO-ESP), a signature project of the NHLBI Recovery Act investment, was designed to identify genetic variants in coding regions (exons) of the human genome (the "exome") that are associated with heart, lung and blood diseases. These and related diseases that are of high impact to public health and individuals from diverse racial and ethnic groups will be studied. These data may help researchers understand the causes of disease, contributing to better ways to prevent, diagnose, and treat diseases, as well as determine whether to tailor prevention and treatments to specific populations. This could lead to more effective treatments and reduce the likelihood of side effects. GO-ESP is comprised of five collaborative components: 3 cohort consortia - HeartGO, LungGO, and WHISP - and 2 sequencing centers - BroadGO and SeattleGO. The exome sequencing asthma project includes 200 African-Americans with asthma from the NHLBI multicenter Severe Asthma Research Program (SARP). SARP participants were recruited at the NHLBI SARP sites with an emphasis on recruiting severe asthmatics (Moore et al., Am J Respir Crit Care Med, 2010. PMID: 19892860). Asthma status was based on both a physician's diagnosis and either bronchodilator reversibility or hyper-responsiveness to methacholine as well as less than 5 pack years of smoking. All subjects were carefully characterized using the standardized SARP protocol which included spirometry (medication withheld), maximum bronchodilator reversibility, hyper-responsiveness to methacholine (not performed in subjects with low baseline FEV1), skin-tests to common allergens, questionnaires on health care utilization and medication use and sputum, lung imaging and bronchoscopy in a subset. In addition GWAS data are available (phs000355, Illumina platform).

pht003223.v1.p1

1 Grupo de itens 5 Elementos de dados

pht003224.v1.p1

1 Grupo de itens 3 Elementos de dados

pht003225.v1.p1

1 Grupo de itens 15 Elementos de dados

pht003226.v1.p1

1 Grupo de itens 4 Elementos de dados

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

- 12/10/2022 - 6 Formulários, 1 Grupo de itens, 3 Elementos de dados, 1 Idioma
Grupo de itens: 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 Grupo de itens 4 Elementos de dados

pht002408.v3.p3

1 Grupo de itens 6 Elementos de dados

pht002410.v3.p3

1 Grupo de itens 106 Elementos de dados

pht003356.v3.p3

1 Grupo de itens 4 Elementos de dados

pht002409.v3.p3

1 Grupo de itens 3 Elementos de dados

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Screening Part 5 - Pulmonary function: Methacholine and Asthma-allergen challenge

- 27/09/2021 - 1 Formulário, 8 Grupos de itens, 41 Elementos de dados, 1 Idioma
Grupos de itens: Pulmonary function tests: Pre-Methacholine Challenge, Pulmonary function tests: Methacholine Challenge, Pulmonary function tests: Post-Methacholine Challenge, PC20 (Methacholine Challenge), Skin Prick Test, Pulmonary function tests: pre-asthma-allergen challenge, Pulmonary function tests: asthma-allergen Challenge, Pulmonary function tests: Post-asthma-allergen Challenge
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Screening Part 5 - Pulmonary function: Methacholine and Asthma-allergen challenge.

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

- 20/09/2021 - 1 Formulário, 10 Grupos de itens, 72 Elementos de dados, 2 Idiomas
Grupos de itens: 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)

- 20/09/2021 - 4 Formulários, 10 Grupos de itens, 72 Elementos de dados, 2 Idiomas
Grupos de itens: 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 Grupos de itens 29 Elementos de dados

Microbiology- Summary sheet

4 Grupos de itens 23 Elementos de dados

Microbiology- Sputum, Serum and EDTA blood

3 Grupos de itens 13 Elementos de dados

Spirometry Documentation form for lung function test Routine documentation in German hospitals DMI - Spirometry Documentation form for lung function test

- 20/09/2021 - 1 Formulário, 5 Grupos de itens, 45 Elementos de dados, 1 Idioma
Grupos de itens: Patient information, Admission information, patient compliance, best value, Report
Routine documentation in German hospitals. Source file name: DG060108_Dokumentationsbogen Lungenfunktionsprüfung/ Spirometrie.061 Examplary forms provided by DMI (http://www.dmi.de/)

clinic internal medicine B SHIP-START-3 operational data lung function

- 03/07/2021 - 1 Formulário, 1 Grupo de itens, 58 Elementos de dados, 2 Idiomas
Grupo de itens: operational data lung function
operational data lung function form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name SHIP.SHIP3.IMB.LUF.LUFOPD. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617 The English version of this form is under development.

Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Logs and Repeats - Concomitant Medications; 12-Lead ECG; Vital Signs; Laboratory; Urinalysis; Pulmonary Function Tests; Nasal Airflow Resistance; Nasal Inspection

- 11/03/2021 - 1 Formulário, 13 Grupos de itens, 80 Elementos de dados, 1 Idioma
Grupos de itens: Concomitant Medication, 12-Lead ECG/ Holter/ Telemetry ECG, ECG Abnormalities, Vital Signs, Local Laboratory, Local Laboratory - Haematology , Local Laboratory - Clinical Chemistry, Urinalysis - Local, Urinalysis - Local: Dipstick Details, Urinalysis - Local: Microscopy Details, Pulmonary Function Tests, Nasal Airflow Resistance, Nasal Inspection
Study ID: 110159 Clinical Study ID: 110159 Study Title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00824356 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, GSK1004723 (200mg), GSK1004723 (1000mg) Study Indication: Allergic Rhinitis

Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Visit 2, 4, 6 - Challenge Date and Time; Pulmonary Function Tests; Nasal Allergen Challenge; Nasal Airflow Resistance; Nasal Secretions; VAS

- 25/02/2021 - 1 Formulário, 21 Grupos de itens, 59 Elementos de dados, 1 Idioma
Grupos de itens: Date of Visit, Challenge Date and Time (0-4 Hr), Pulmonary Function Tests - Challenge Date and Time, Pulmonary Function Tests - Start of Challenge, Pulmonary Function Tests - 1 hr Post Challenge Start, Pulmonary Function Tests - 2 hr Post Challenge Start , Pulmonary Function Tests - 3 hr Post Challenge Start, Pulmonary Function Tests - 4 hr Post Challenge Start , Nasal Allergen Challenge - Challenge Date and Time, Nasal Allergen Challenge - Start of Challenge, Nasal Allergen Challenge, Nasal Airflow Resistance - Challenge Date and Time, Nasal Airflow Resistance - 30 Min Post-Challenge, Nasal Airflow Resistance, Nasal Secretions - Challenge Date and Time, Nasal Secretions - Start of Challenge, Nasal Secretions, VAS - Challenge Date and Time, VAS - Dosing Date and Time, VAS - Start of Challenge, VAS
Study ID: 110159 Clinical Study ID: 110159 Study Title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00824356 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, GSK1004723 (200mg), GSK1004723 (1000mg) Study Indication: Allergic Rhinitis

Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Visit 1, 3, 5 - Challenge Date and Time; Pulmonary Function Tests; Nasal Allergen Challenge; Nasal Airflow Resistance; Nasal Secretions; VAS

- 25/02/2021 - 1 Formulário, 25 Grupos de itens, 68 Elementos de dados, 1 Idioma
Grupos de itens: Challenge Date and Time (Visit 1, 3, 5), Pulmonary Function Tests - Challenge Date and Time (Visit 1, 3, 5), Pulmonary Function Tests - Dosing Date and Time (Visit 1, 3, 5), Pulmonary Function Tests - Start of Challenge (Visit 1, 3, 5), Pulmonary Function Tests - 1 hr Post Challenge Start (Visit 1, 3, 5), Pulmonary Function Tests - 2 hr Post Challenge Start (Visit 1, 3, 5), Pulmonary Function Tests - 3 hr Post Challenge Start (Visit 1, 3, 5), Pulmonary Function Tests - 4 hr Post Challenge Start (Visit 1, 3, 5), Pulmonary Function Tests - 5 hr Post Challenge Start (Visit 1, 3, 5), Pulmonary Function Tests - 6 hr Post Challenge Start (Visit 1, 3, 5), Nasal Allergen Challenge - Challenge Date and Time (Visit 1, 3, 5), Nasal Allergen Challenge - Dosing Date and Time (Visit 1, 3, 5), Nasal Allergen Challenge - Start of Challenge (Visit 1, 3, 5), Nasal Allergen Challenge (Visit 1, 3, 5), Nasal Airflow Resistance - Challenge Date and Time (Visit 1, 3, 5), Nasal Airflow Resistance - 30 Min Post-Challenge (Visit 1, 3, 5), Nasal Airflow Resistance (Visit 1, 3, 5), Nasal Secretions - Challenge Date and Time (Visit 1, 3, 5), Nasal Secretions - Dosing Date and Time (Visit 1, 3, 5), Nasal Secretions - Start of Challenge (Visit 1, 3, 5), Nasal Secretions (Visit 1, 3, 5), VAS - Challenge Date and Time (Visit 1, 3, 5), VAS - Dosing Date and Time (Visit 1, 3, 5), VAS - Start of Challenge (Visit 1, 3, 5), VAS (Visit 1, 3, 5)
Study ID: 110159 Clinical Study ID: 110159 Study Title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00824356 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, GSK1004723 (200mg), GSK1004723 (1000mg) Study Indication: Allergic Rhinitis

Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Screening - Challenge Date and Time; Pulmonary Function Tests; Nasal Allergen Challenge; Nasal Airflow Resistance; Nasal Secretions; VAS

- 19/02/2021 - 1 Formulário, 17 Grupos de itens, 48 Elementos de dados, 1 Idioma
Grupos de itens: Challenge Date and Time, Pulmonary Function Tests - Challenge Date and Time, Pulmonary Function Tests - Start of Challenge, Pulmonary Function Tests - 1 hr Post Challenge Start, Pulmonary Function Tests - 2 hr Post Challenge Start , Nasal Allergen Challenge - Challenge Date and Time, Nasal Allergen Challenge - Pre-Dose, Nasal Allergen Challenge - 20 Min; 40 Min; 1 Hr; 1 Hr 20 Min; 1 Hr 40 Min; 2 Hr, Nasal Airflow Resistance - Challenge Date and Time, Nasal Airflow Resistance - 30 Min Post-Challenge, Nasal Airflow Resistance - 1 Hr 30 Min Post Challenge, Nasal Secretions - Challenge Date and Time, Nasal Secretions - Start of Challenge, Nasal Secretions - 1 Hr and 2 Hr Post-Challenge Start , VAS - Challenge Date and Time, VAS - Pre-Dose, VAS - 20 Min; 40 Min; 1 Hr; 1 Hr 20 Min; 1 Hr 40 Min; 2 Hr
Study ID: 110159 Clinical Study ID: 110159 Study Title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00824356 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, GSK1004723 (200mg), GSK1004723 (1000mg) Study Indication: Allergic Rhinitis

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