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

- 2022-12-13 - 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

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Dermatological/Hypersensitivity Adverse Event Form

- 2021-09-20 - 1 Formulär, 11 Item-grupper, 66 Dataelement, 1 Språk
Item-grupper: Administrative Data, Dermatological/Hypersensitivity Adverse Event, Systemic Symptoms, Signs or Laboratory Abnormalities, Haematologic Abnormalities, Supportive/Investigative Measures, Diagnosis, Responsible for Diagnosis, Lesion Location, Concomitant Medication, Infections, Conclusion
Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information about any dermatological or hypersensitivity adverse event form. It should be filled out when any of those occur during the study. Record details of any dematological/hypersensitivity adverse event in the appropriate Non-Serious Adverse/Serious Adverse Event section of the CRF. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Dermatological Drug Reaction History

- 2018-12-16 - 1 Formulär, 2 Item-grupper, 31 Dataelement, 1 Språk
Item-grupper: Administrative Data, Dermatological Drug Reaction History
Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information about the subjects history of dermatological drug reactions. It should be filled out at each treatment period visit. Complete the Dermatological Drug Reaction History pages for each drug reaction experienced. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Personal Medical History of Allergies, Infectious Diseases, and Immunizations - Child PhenX Toolkit

- 2016-04-26 - 1 Formulär, 1 Item-grupp, 21 Dataelement, 1 Språk
Item-grupp: PhenX - personal medical history of allergies, infectious diseases, and immunizations - child protocol
This protocol is a proxy-administered personal health record from the American Health Information Management Association (AHIMA). The parent or guardian is asked to provide details on the child in the following categories: Birth, Health Log, Allergies/Drug Sensitivities, Infectious Disease, and Immunizations. ODM derived from: https://cde.nlm.nih.gov Primary source: https://www.phenxtoolkit.org/ Recent publication: Hendershot, T., Pan, H., Haines, J., Harlan, W.R., Marazita, M.L., McCarty, C.A., Ramos, E.M., and Hamilton, C.M. (2015) Using the PhenX toolkit to add standard measures to a study. Curr. Protoc. Hum. Genet. 86:1.21.1-1.21.17. doi: 10.1002/0471142905.hg0121s86 Permission to publish granted by Carol M. Hamilton.

FHIR v4.0.1 - Resource Allergy Intolerance (3)

- 2021-09-20 - 1 Formulär, 1 Item-grupp, 17 Dataelement, 1 Språk
Item-grupp: Allergy Intolerance
This form contains an incomplete implementation of the FHIR Resource AllergyIntolerance, v4.0.1 . After preliminary review, it contains the data elements that request clinical information. https://www.hl7.org/fhir/resourcelist.html (accessed at 28.11.2019)

Allergy Medical History - Allergy Medical History (Allergieanamnese)

- 2019-01-18 - 1 Formulär, 4 Item-grupper, 42 Dataelement, 2 Språk
Item-grupper: Administrative data, Current complaints, Medical History, Information about findings
This form is used for routine documentation. It originates from a medical practice for internal medicine in Cologne-Lindenthal (medical practice Astrid Schareina and Dr. Christina Lind-Weiland, Lindenthalgürtel 36, 50935 Cologne). Published with permission by A. Schareina and Dr. C. Lind-Weiland. Explanation for patients: Your symptoms (or those of your child) may be allergic, i.e. they may be due to certain substances in your environment (or that of your child). To find the allergy triggers, please answer the following questions. Ihre Beschwerden (oder die Ihres Kindes) können allergischen Ursprungs sein, d. h. sie können auf bestimmte Stoffe in Ihrer Umgebung (oder der Ihres Kindes) zurückzuführen sein. Um die Allergieauslöser zu finden, beantworten Sie bitte folgende Fragen:

Hypersensitivity Reaction Record GSK study Chronic Coronary Heart Disease NCT00799903

- 2018-01-03 - 1 Formulär, 16 Item-grupper, 69 Dataelement, 1 Språk
Item-grupper: Event number, Food allergies, Hymenoptera sting allergy, Latex allergy, 5. Penicillin allergy, Cephalosporin allergy, Aspirin allergy, NSAID allergy, ACE inhibitor allergy, Other allergies, Stevens-Johnson syndrome, Toxic epidermal necrolysis, Urticaria (hives), Angioedema, Anaphylactic/Anaphylactoid reaction, Other symptoms of hypersensitivity reaction
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Hypersensitivity Reaction Record - Repeating form (Scheduled visits)

HNO Skin Prick Test MS University Hospital Muenster (UKM)

- 2016-10-02 - 1 Formulär, 3 Item-grupper, 9 Dataelement, 1 Språk
Item-grupper: Medical History, Skin Prick Test, Diagnosis
Hospital Routine Documentation Form at the University Hospital Muenster. Original Form name: HNO Skin-Prick-Test Dokumentationsbogen.

Adverse Reaction Risk (OpenEHR)

- 2015-08-06 - 1 Formulär, 2 Item-grupper, 27 Dataelement, 1 Språk
Item-grupper: Adverse reaction, Reaction Event
http://openehr.org/ckm/

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