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dbGaP phs000961 eMERGE III: Columbia GENIE (Genomic Integration with EHR) - pht005331.v1.p1

- 31/01/24 - 5 moduli, 1 ItemGroup, 3 elementi, 1 linguaggio
ItemGroup: pht005331
Principal Investigator: Chunhua Weng, PhD, Department of Biomedical Informatics, Columbia University, College of Physicians and Surgeons, New York, NY, USA MeSH: NA,Renal Insufficiency, Chronic,Alzheimer Disease,Aortic Aneurysm, Abdominal,Asthma,Attention Deficit Disorder with Hyperactivity,Clostridium difficile,Dermatitis, Atopic,Diabetes Mellitus, Type 2,Heart Diseases,Herpes Zoster,Hypothyroidism,Methicillin-Resistant Staphylococcus aureus,Prostatic Hyperplasia https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000961 The Columbia GENIE study contributes and shares phenotype and genotype data for individuals who were treated with our healthcare facilities and consented to share their data with dbGaP for scientific discovery. Some of these individuals have kidney or neurological problems and some are healthy volunteers from the Washington Height patient community. The purpose of this NOMAS study is to obtain information about physical features of the brain, carotid arteries, and heart. Some of our patients are pediatric patients with cardiac conditions. The study sample consists of four patient cohorts: - Northern Manhattan Study (NOMAS), N=1072 - Pediatric Cardiac Genomic Consortium (PCGC), n=374 - Caribbean Hispanics with Familial and Sporadic Late Onset Alzheimer's disease (Caribbean Hispanics/AD), n=330 - Alzheimer's Disease Sequencing Project (ADSP, n=44) - Genetics of Chronic Kidney Disease Study, n=1256

pht005332.v1.p1

1 ItemGroup 23 elementi

pht005333.v1.p1

1 ItemGroup 3 elementi

Eligibility

1 ItemGroup 3 elementi

pht005330.v1.p1

1 ItemGroup 4 elementi

IDMC Consensus Report - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

- 03/09/17 - 1 modulo, 8 itemgroups, 25 elementi, 1 linguaggio
Itemgroups: Rash, Fever, Systemic signs, Subjective assessment of the illness by investigator, Varicella Clinical Case?, PCR result, Classification varicella, Expert signature
IDMC Consensus Report - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Phase A - Year 1 - Visit 4 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

- 02/09/17 - 1 modulo, 5 itemgroups, 15 elementi, 1 linguaggio
Itemgroups: Check for study continuation, Laboratory tests, Household exposure, Household exposure number, Varicella or zoster
Phase A - Year 1 - Visit 4 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Phase A - Year 2 - Visit 5 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

- 02/09/17 - 1 modulo, 5 itemgroups, 15 elementi, 1 linguaggio
Itemgroups: Check for study continuation, Laboratory tests, Household exposure, Household exposure number, Varicella or zoster
Phase A - Year 2 - Visit 5 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Phase A - Year 2 - Telephone contact 2 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

- 02/09/17 - 1 modulo, 5 itemgroups, 10 elementi, 1 linguaggio
Itemgroups: Subject's contact, Household exposure, Household exposure number, Varicella or zoster, Serious adverse event
Phase A - Year 2 - Telephone contact 2 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Phase A - Year 2 - Telephone contact 3 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

- 02/09/17 - 1 modulo, 5 itemgroups, 10 elementi, 1 linguaggio
Itemgroups: Subject's contact, Household exposure, Household exposure number, Varicella or zoster, Serious adverse event
Phase A - Year 2 - Telephone contact 3 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Phase A - Year 2 - Telephone contact 10 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

- 02/09/17 - 1 modulo, 5 itemgroups, 10 elementi, 1 linguaggio
Itemgroups: Subject's contact, Household exposure, Household exposure number, Varicella or zoster, Serious adverse event
Phase A - Year 2 - Telephone contact 10 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Phase A - Year 2 - Telephone contact 9 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

- 02/09/17 - 1 modulo, 5 itemgroups, 10 elementi, 1 linguaggio
Itemgroups: Subject's contact, Household exposure, Household exposure number, Varicella or zoster, Serious adverse event
Phase A - Year 2 - Telephone contact 9 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Phase A - Year 2 - Telephone contact 6 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

- 02/09/17 - 1 modulo, 5 itemgroups, 10 elementi, 1 linguaggio
Itemgroups: Subject's contact, Household exposure, Household exposure number, Varicella or zoster, Serious adverse event
Phase A - Year 2 - Telephone contact 6 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Phase A - Year 2 - Telephone contact 8 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

- 02/09/17 - 1 modulo, 5 itemgroups, 10 elementi, 1 linguaggio
Itemgroups: Subject's contact, Household exposure, Household exposure number, Varicella or zoster, Serious adverse event
Phase A - Year 2 - Telephone contact 8 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Phase A - Year 2 - Telephone contact 5 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

- 02/09/17 - 1 modulo, 5 itemgroups, 10 elementi, 1 linguaggio
Itemgroups: Subject's contact, Household exposure, Household exposure number, Varicella or zoster, Serious adverse event
Phase A - Year 2 - Telephone contact 5 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Phase A - Year 2 - Telephone contact 4 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

- 02/09/17 - 1 modulo, 5 itemgroups, 10 elementi, 1 linguaggio
Itemgroups: Subject's contact, Household exposure, Household exposure number, Varicella or zoster, Serious adverse event
Phase A - Year 2 - Telephone contact 4 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

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