Zoekresultaten - Portaal voor medische datamodellen (MDM-portaal)

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

- 12/13/22 - 5 Formulieren, 1 Itemgroep, 7 Data-elementen, 1 Taal

Itemgroep: 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.

Study completion_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79 - Study completion form

- 9/27/21 - 1 Formulier, 5 Itemgroepen, 30 Data-elementen, 1 Taal

Itemgroepen: Study completion, Hematology, Biochemistry, Withdrawal of demand medication, Assessment

Study part: Study completion form.Effectiveness and tolerance of sublingual desensitization with LAIS grass tablets in Patients with an allergic rhinoconjunctivitis caused by grass pollen. A prospective, multi-center, doubleblind, randomized, placebo-controlled Phase III study. Principal Investigator Prof. Dr. med. Ralph Mösges.

Visit V5_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79 - Visit V5 (Day 140 + - 14)

- 9/27/21 - 1 Formulier, 8 Itemgroepen, 49 Data-elementen, 1 Taal

Itemgroepen: Visit, Physical examination, Medical Examination Rhinoscope, Spirometry; Peak Expiratory Flow, Medication, Hematology, Biochemistry, medication Demand

Study part: Visit V5 (Day 140 + - 14). Effectiveness and tolerance of sublingual desensitization with LAIS grass tablets in Patients with an allergic rhinoconjunctivitis caused by grass pollen. A prospective, multi-center, doubleblind, randomized, placebo-controlled Phase III study. Principal Investigator Prof. Dr. med. Ralph Mösges.

Visit V6_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79 - Visit V6 (Day 196 + - 14)

- 9/27/21 - 1 Formulier, 5 Itemgroepen, 35 Data-elementen, 1 Taal

Itemgroepen: Visit, Physical examination, Medical Examination Rhinoscope, Spirometry; Peak Expiratory Flow, medication Demand

Study part: Visit V6 (Day 196 + - 14). Effectiveness and tolerance of sublingual desensitization with LAIS grass tablets in Patients with an allergic rhinoconjunctivitis caused by grass pollen. A prospective, multi-center, doubleblind, randomized, placebo-controlled Phase III study. Principal Investigator Prof. Dr. med. Ralph Mösges.

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

- 9/20/21 - 1 Formulier, 11 Itemgroepen, 66 Data-elementen, 1 Taal

Itemgroepen: 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

FHIR v4.0.1 - Resource Allergy Intolerance (3)

- 9/20/21 - 1 Formulier, 1 Itemgroep, 17 Data-elementen, 1 Taal

Itemgroep: 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)

Hypersensitivity/ Anaphylaxis Evaluation Mepolizumab HES NCT00086658 - Hypersensitivity/ Anaphylaxis Evaluation

- 9/20/21 - 1 Formulier, 1 Itemgroep, 53 Data-elementen, 1 Taal

Itemgroep: evaluation Hypersensitivity

Study part: Hypersensitivity/ Anaphylaxis Evaluation.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Visit V0 LAIS grass tablets by allergic rhinoconjunctivitis EudraCT-Nr.2012-004916-79 - Visit V0 Screening visit

- 9/20/21 - 1 Formulier, 18 Itemgroepen, 157 Data-elementen, 1 Taal

Itemgroepen: Inclusion Criteria, Exclusion Criteria, demographics, Laboratory, Physical examination, Medical Examination Rhinoscope, History of allergies, Clinical symptoms, Score Rhinoconjunctivitis, Concomitant medication, medical history, skin prick test, Spirometry; Peak Expiratory Flow, Conjunctival provocation testing, diagnostics allergy, Hematology, Biochemistry, Inclusion Criteria

Study part: Visit V0 Screening visit. Effectiveness and tolerance of sublingual desensitization with LAIS grass tablets in Patients with an allergic rhinoconjunctivitis caused by grass pollen. A prospective, multi-center, doubleblind, randomized, placebo-controlled Phase III study. Principal Investigator Prof. Dr. med. Ralph Mösges.

Persönliches Interview SHIP-Trend-1 Allergien

- 2/13/21 - 1 Formulier, 1 Itemgroep, 35 Data-elementen, 1 Taal

Itemgroep: Allergien

Allergien form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name TREND.TREND1.INT.ALLERG.ALLERG. 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

Concomitant medication_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79 - Documentation concomitant medication

- 10/30/19 - 1 Formulier, 1 Itemgroep, 7 Data-elementen, 1 Taal

Itemgroep: Concomitant medication

Study part: Documentation concomitant medication. Effectiveness and tolerance of sublingual desensitization with LAIS grass tablets in Patients with an allergic rhinoconjunctivitis caused by grass pollen. A prospective, multi-center, doubleblind, randomized, placebo-controlled Phase III study. Principal Investigator Prof. Dr. med. Ralph Mösges.

Allergy Medical History - Allergy Medical History (Allergieanamnese)

- 1/18/19 - 1 Formulier, 4 Itemgroepen, 42 Data-elementen, 2 Talen

Itemgroepen: 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:

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

- 12/16/18 - 1 Formulier, 2 Itemgroepen, 31 Data-elementen, 1 Taal

Itemgroepen: 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

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