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dbGaP phs000495 The Gene Partnership (TGP) - eMERGE Data - Eligibility

- 13.12.22 - 5 Formulär, 1 Item-grupp, 7 Dataelement, 1 Språk
Item-grupp: IG.elig
Principal Investigator: Isaac S. Kohane, MD, PhD, Boston Children's Hospital, Boston, MA, USA MeSH: Autistic Disorder,Heart Defects, Congenital,Asthma,Attention Deficit Disorders,Diabetes Mellitus, Type 1,Diabetes Mellitus, Type 2,Epilepsy,Gastrointestinal Diseases,Hypersensitivity,Autoimmune Diseases,Hematologic Diseases,Neoplasms,Arrhythmias, Cardiac,Chromosome Aberrations,Congenital Abnormalities,Dermatology,Developmental Disabilities,Endocrine System,Otolaryngology,Syndrome,Urogenital System,Hearing Loss,Immune System Diseases,Musculoskeletal Abnormalities,Nervous System Diseases,Neuromuscular Diseases,Metabolic Diseases,Nutrition Disorders,Vision Disorders,Mouth Diseases,Mental Disorders,Kidney Diseases,Respiration Disorders,Thyroid Diseases,Vascular Diseases https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000495 The Gene Partnership (TGP) is a prospective longitudinal registry at Boston Children's Hospital (BCH) to study the genetic and environmental contributions to childhood health and disease, collect genetic information on a large number of children who have been phenotyped, and implement the Informed Cohort and the Informed Cohort Oversight Board (ICOB). The term "*The Gene Partnership*" reflects a partnership between researchers and participants. Children seen at BCH are offered enrollment, as are their parents and siblings. DNA is collected on all enrollees. BCH has a comprehensive EMR system, and virtually all inpatient and outpatient data are captured electronically. Clinical data in the BCH EMR is loaded in the i2b2 data warehouse which is available to investigators. Cases, phenotypes, and covariates are ascertained using the i2b2 database. Participants at BCH in TGP have consented to receive any research result and/or incidental finding that arises from studies using TGP that is approved by the Informed Cohort Oversight Board (ICOB) and is in accordance with the participants' preferences; results are returned through the Personally Controlled Health Record (PCHR). BCH and Cincinnati Children's Hospital Medical Center (CCHMC) have partnered as the *P*ediatric *A*lliance for *G*enomic and *E*lectronic Medical Record (EMR) *R*esearch (*PAGER*) site for the eMERGE Phase II network for pediatric institutions, and the cohort for eMERGE at BCH is TGP.

pht002864.v1.p1

1 Item-grupp 4 Dataelement

pht002865.v1.p1

1 Item-grupp 5 Dataelement

pht002866.v1.p1

1 Item-grupp 42 Dataelement

pht002867.v1.p1

1 Item-grupp 4 Dataelement

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - IMD Report - Scleroderma or Morphea; Dermatomyositis or Polymyositis; Diabetes mellitus Type I (Report Final and Annex Report 2 Final)

- 02.11.20 - 1 Formulär, 25 Item-grupper, 95 Dataelement, 1 Språk
Item-grupper: Administrative, Scleroderma or Morphea, Scleroderma or Morphea - Signs and Symptoms, Scleroderma or Morphea - Other signs and symptoms, Scleroderma or Morphea - Other signs and symptoms , Scleroderma or Morphea - Diagnostic Test Results, Scleroderma or Morphea - Other Diagnostic Test Results , Scleroderma or Morphea - Other Diagnostic Test Results , Scleroderma or Morphea - Other diagnostic Procedure, Dermatomyositis or Polymyositis, Dermatomyositis or Polymyositis - Signs and symptoms (supporting the final diagnosis), Dermatomyositis or Polymyositis - Other Signs and symptoms, Dermatomyositis or Polymyositis - Other Signs and symptoms , Dermatomyositis or Polymyositis - Diagnostic Test Results, Dermatomyositis or Polymyositis - Other Diagnostic Test Results , Dermatomyositis or Polymyositis - Other Diagnostic Test Results , Dermatomyositis or Polymyositis - Other diagnostic Procedure , Diabetes mellitus type I, Diabetes mellitus type I - Signs and symptoms (supporting the final diagnosis), Diabetes mellitus type I - Other Signs and symptoms , Diabetes mellitus type I - Other Signs and symptoms , Diabetes mellitus type I - Diagnostic Test Results , Diabetes mellitus type I - Other Diagnostic Test Results , Diabetes mellitus type I - Other Diagnostic Test Results , Diabetes mellitus type I - Other diagnostic Procedure
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Eligibility Type 1 Diabetes Mellitus NCT00449891

- 08.11.18 - 1 Formulär, 2 Item-grupper, 12 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Neuropsychological and Neuroanatomical Studies of Young Children With and Without Type 1 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00449891

Eligibility Type 1 Diabetes Mellitus NCT00130481

- 29.06.17 - 1 Formulär, 2 Item-grupper, 8 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT); ODM derived from: https://clinicaltrials.gov/show/NCT00130481

Eligibility Diabetes NCT00605137

- 20.09.21 - 1 Formulär, 2 Item-grupper, 12 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Safety of Insulin Detemir in Children With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00605137

Eligibility Type 1 Diabetes NCT01354288

- 19.12.19 - 1 Formulär, 2 Item-grupper, 10 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Therapeutic Education in Very Young Children With Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT01354288

Eligibility Type 1 Diabetes Mellitus NCT02144337

- 04.01.16 - 1 Formulär, 2 Item-grupper, 10 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Physical Activity in Children With Type 1 Diabetes Study; ODM derived from: https://clinicaltrials.gov/show/NCT02144337

Eligibility Diabetes Mellitus, Type 1 NCT00179777

- 10.06.16 - 1 Formulär, 2 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
TRIGR - Primary Prevention Study for Type 1 Diabetes in Children at Risk; ODM derived from: https://clinicaltrials.gov/show/NCT00179777

Eligibility Diabetes Mellitus, Insulin-Dependent NCT00069615

- 29.08.16 - 1 Formulär, 2 Item-grupper, 13 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Pilot Study of the GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children; ODM derived from: https://clinicaltrials.gov/show/NCT00069615

Eligibility Type I Diabetes NCT01477476

- 13.03.16 - 1 Formulär, 2 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Anti-IL-1 Treatment in Children DKA at Diagnosis of Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01477476

Eligibility Diabetes NCT01513473

- 13.11.19 - 1 Formulär, 2 Item-grupper, 12 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT01513473

Eligibility Type 1 Diabetes Mellitus NCT00476788

- 04.09.17 - 1 Formulär, 2 Item-grupper, 12 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Fast Track CSII Using a Novel Device in Young Children With Newly Diagnosed T1DM; ODM derived from: https://clinicaltrials.gov/show/NCT00476788

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