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Smart Device System Meta Data Definitions - Neurologic Examination

- 9/3/20 - 7 moduli, 1 ItemGroup, 6 elementi, 2 lingue
ItemGroup: Neurologic examination
Metadata definitions for the Smart Device System for Movement Disorders. Clinical Protocol and Registration Information available on: https://clinicaltrials.gov/ct2/show/NCT03638479 Principal Investigator: Julian Varghese Description for Assessment Steps for Neurologic Examination are available under: Varghese J, Niewöhner S, Soto-Rey I, et al. A Smart Device System to Identify New Phenotypical Characteristics in Movement Disorders. Front Neurol. 2019;10:48. doi:10.3389/fneur.2019.00048

Family History

1 ItemGroup 2 elementi

Medication

1 ItemGroup 3 elementi

Vital Signs

1 ItemGroup 1 elemento

PD NMS

1 ItemGroup 1 elemento

Demography

2 itemgroups 5 elementi

Medical History

1 ItemGroup 9 elementi

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

- 12/1/23 - 4 moduli, 1 ItemGroup, 1 elemento, 1 linguaggio
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 elementi

pht004910.v4.p3

1 ItemGroup 2 elementi

pht004911.v3.p3

1 ItemGroup 9 elementi

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

- 3/5/23 - 4 moduli, 1 ItemGroup, 6 elementi, 1 linguaggio
ItemGroup: 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 ItemGroup 4 elementi

pht008603.v1.p1

1 ItemGroup 2 elementi

pht008604.v1.p1

1 ItemGroup 10 elementi

NINDS CDE Biospecimens Summary Statement Multiple Sclerosis - Biospecimens Summary Statement Appendix B – Potential MS Biomarkers

- 9/17/21 - 1 modulo, 6 itemgroups, 64 elementi, 1 linguaggio
Itemgroups: biomarkers serum MS, biomarkers Cell surface, biomarker humoral antibody, biomarker adhesion migration, Biomarker tissue damage repair, Biomarker other
NINDS Common Data Elements, Multiple Sclerosis Biospecimens Summary Statement Appendix B – Potential MS Biomarkers Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455 - Visit 2 - Biomarker Samples; Pharmacogenetic Research Consent; Transcriptomic Research Sample Collection Details; PK Blood Sample; Vital Signs; Investigational Product IV Dosing

- 3/18/20 - 1 modulo, 9 itemgroups, 44 elementi, 1 linguaggio
Itemgroups: Biomarker Samples, Pharmacogenetic Research Consent/ Blood Sample Collection, Transcriptomic Research Sample Collection Details, PK Blood Sample - Before Infusion, PK Blood Sample - End of Infusion, PK Type Code, Vital Signs, Investigational Product - IV Dosing, Total Volume of Infusion unit
Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid

Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455 - Screen - Biomarker Samples; Diagnosis/ History of Rheumatoid Arthritis; Prior Methotrexate Treatment; Prior RA Medications; Screen Failure

- 3/17/20 - 1 modulo, 7 itemgroups, 31 elementi, 1 linguaggio
Itemgroups: Biomarker Samples, Diagnosis/ History of Rheumatoid Arthritis, Prior Methotrexate Treatment, Prior Methotrexate Treatment , Prior RA Medications, Prior RA Medications , Screen Failure
Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid

Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363 - Biomarker Sample

- 10/29/19 - 1 modulo, 2 itemgroups, 6 elementi, 1 linguaggio
Itemgroups: Experimental drug, Dosage, Date in time, Time, Biological Markers, Specimen
Study ID: 109035 Clinical Study ID: 109035 Study Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00896363 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK163090 1 mg, GSK163090 Placebo, GSK163090 3 mg Trade Name: Study Indication: Depressive Disorder

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Week 8 - Vital Signs; Local Laboratory - Haematology, Clinical Chemistry, Liver Events Assessment; Urinalysis; Urinalysis - Local: 24h Protein Details; Investigational Product Compliance - Pazopanib; Biomarker Samples

- 5/17/19 - 1 modulo, 9 itemgroups, 158 elementi, 1 linguaggio
Itemgroups: Date of visit/ assessment, Vital Signs, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Local Laboratory - Urinalysis, Urinalysis - Local: 24 hour Protein Details, Liver Assessment, Investigatoinal Product Compliance - Pazopanib , Biomarker Sample
Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Week 4 - Vital Signs; 12-Lead- ECG; Local Laboratory - Haematology, Clinical Chemistry, Liver Assessment; Urinalysis; Urinalysis - Local: 24h Protein Details; Investigational Product Compliance - Pazopanib; Biomarker Samples

- 5/17/19 - 1 modulo, 10 itemgroups, 164 elementi, 1 linguaggio
Itemgroups: Date of visit/ assessment, Vital Signs, 12-Lead ECG, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Local Laboratory - Urinalysis, Urinalysis - Local: 24 hour Protein Details, Liver Assessment, Investigatoinal Product Compliance - Pazopanib , Biomarker Sample
Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Week 1 - Vital Signs; 12-Lead- ECG; Local Laboratory - Haematology, Clinical Chemistry; Investigational Product Compliance - Pazopanib; Liver Events Assessment; Biomarker Samples

- 5/16/19 - 1 modulo, 8 itemgroups, 149 elementi, 1 linguaggio
Itemgroups: Date of visit/ assessment, Vital Signs, 12-Lead ECG, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Investigational Product Compliance - Pazopanib, Liver Events Assessment, Biomarker Sample
Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Day 1 Pre-Dose -Vital Signs; Pharmacogenetic Research Consent/ Blood Sample Collection; Investigational Product Compliance (Pazopanib); Investigational Product (First Dose); Biomarker Samples

- 5/16/19 - 1 modulo, 6 itemgroups, 30 elementi, 1 linguaggio
Itemgroups: Date of visit/ assessment, Vital Signs, Pharmacogenetic Research Consent/ Blood Sample Collection, Investigational Product Compliance - Pazopanib, Investigational Product - First Dose, Biomarker Sample
Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556 - SRT501 + Bortezomib Cycle __ Day 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; Radiographic Assessment; Disease Marker Assessment; Disease Response; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

- 3/10/19 - 1 modulo, 23 itemgroups, 107 elementi, 1 linguaggio
Itemgroups: Administrative, Visit Date, Was a physical examination performed?, Physical Examination, Vital Signs, 12-Lead ECG, ECG Result, ECG Findings, Hematology, Hematology , Clinical Chemistry, Coagulation and Electrolytes, Clinical Chemistry, Coagulation and Electrolytes , Urinalysis dipstick results, Urinalysis microscopy results, Urinalysis microscopy results , Serum beta-hCG Pregnancy Test, Radiographic Assessment, Radiographic Assessment , Disease Marker Assessment , Disease Marker Assessment , Disease Response, Study Treatment Compliance (Return) , New Adverse Events and Concomitant Treatment
Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma

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