Résultats de recherche - Portail des modèles médicaux de données (portail MDM)

NINDS CDE Non-Imaging Diagnostics Recommendations Multiple Sclerosis - Non-Imaging Diagnostics Recommendations

- 13/04/2021 - 1 Formulaire, 6 Groupes Item, 52 Eléments de données, 1 Langue

Groupes Item: ECG, Pulmonary Function Tests, Scalp Electroencephalogram, Immune Cell, Electrophysiology, Studies Nerve Conduction

NINDS Common Data Elements, Multiple Sclerosis Non-Imaging Diagnostics Recommendations 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.

Brain Penetration by [Carbonyl-11C] GSK1034702; 110771 - Day 1 RE-TEST

- 18/12/2019 - 1 Formulaire, 18 Groupes Item, 81 Eléments de données, 1 Langue

Groupes Item: Administrative documentation, Allen test, Vital signs, Pulmonary function tests, 12 lead ECG, Holter Electrocardiography, Positron-Emission Tomography, Pre-dose, Pharmacokinetic aspects - Blood, Randomization, Numbers, Therapeutic procedure, Confirmation, Experimental drug, Positron-Emission Tomography, Post-dose, Physical Examination, Post-dose, Vital signs, Post-dose, Laboratory Procedures, Post-dose, Hematology finding, Laboratory Procedures, Post-dose, Chemistry, Clinical, Urinalysis, Post-dose, Laboratory Procedures, Post-dose, Renal function

Study ID: 110771 Clinical Study ID: 110771 Study Title: An open label positron emission tomography (PET) study to investigate brain penetration by [carbonyl-11C] GSK1034702 in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Positron Emission Tomography Trade Name: Carbonyl-11C Study Indication: Cognitive Disorders, Alzheimer's disease, schizophrenia.

Brain Penetration by [Carbonyl-11C] GSK1034702; 110771 - Day -1

- 15/12/2019 - 1 Formulaire, 11 Groupes Item, 40 Eléments de données, 1 Langue

Groupes Item: Administrative documentation, Vital signs, Holter Electrocardiography, Physical Examination, Urine drug screening; Ethanol measurement, breath test expired carbon monoxide, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Urinalysis, Laboratory Procedures, Renal function, Blood, Laboratory Procedures, Renal function, Urine

Study ID: 110771 Clinical Study ID: 110771 Study Title: An open label positron emission tomography (PET) study to investigate brain penetration by [carbonyl-11C] GSK1034702 in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Positron Emission Tomography Trade Name: Carbonyl-11C Study Indication: Cognitive Disorders, Alzheimer's disease, schizophrenia.

Brain Penetration by [Carbonyl-11C] GSK1034702; 110771 - Day 1

- 17/12/2019 - 1 Formulaire, 19 Groupes Item, 83 Eléments de données, 1 Langue

Groupes Item: Administrative documentation, Allen test, Vital signs, Pulmonary function tests, 12 lead ECG, Holter Electrocardiography, Positron-Emission Tomography, Pre-dose, Pharmacokinetic aspects - Blood, Randomization, Numbers, Therapeutic procedure, Confirmation, Experimental drug, Positron-Emission Tomography, Post-dose, Physical Examination, Post-dose, Vital signs, Post-dose, Laboratory Procedures, Post-dose, Hematology finding, Laboratory Procedures, Post-dose, Chemistry, Clinical, Urinalysis, Post-dose, Laboratory Procedures, Post-dose, Renal function, Blood, Laboratory Procedures, Post-dose, Renal function, Urine

Study ID: 110771 Clinical Study ID: 110771 Study Title: An open label positron emission tomography (PET) study to investigate brain penetration by [carbonyl-11C] GSK1034702 in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Positron Emission Tomography Trade Name: Carbonyl-11C Study Indication: Cognitive Disorders, Alzheimer's disease, schizophrenia.

Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989 - 12-Lead ECG Abnormalities

- 07/10/2019 - 1 Formulaire, 8 Groupes Item, 94 Eléments de données, 1 Langue

Groupes Item: Administrative data, 12 Lead ECG abnormalities, Rhythm, P-Wave and QRS Morphology, Conduction, Myocardial Infarction, Depolarisation/Repolarisation (QRS-T), Other abnormalities

Study ID: 111539 Clinical Study ID: 111539 Study Title: A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of scalating Repeat Doses of GSK249320 in Patients With Stroke Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00833989 https://clinicaltrials.gov/ct2/show/NCT00833989 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Refanezumab, Placebo Trade Name: N/A Study Indication: Ischaemic Attack, Transient The study consists of 8 visits: Day 1, Week 1 (Day 5), Week 2 (Day 10), Week 4 (Day 30), Week 8 (Day 60), Week 12 (Day 90), Week 16 (Day 112), Follow-up (F/U). All subjects will receive two doses. The first dose within 24-72 hrs after stroke the second dose 9 +/- 1 days after the first one. Each dose will be given as an intravenous infusion over 60 minutes. This document contains the ECG Abnormalities form. Fill in if there is a clinical significant ECG Abnormality. It has to be filled in at Day 1, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16 and in case of early withdrawal. Additionally it can be filled in as unscheduled and/or repeated form.

Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989 - 12-Lead-ECG

- 25/09/2019 - 1 Formulaire, 3 Groupes Item, 13 Eléments de données, 1 Langue

Groupes Item: Administrative Data, Dosing Date and Time, 12-Lead-ECG

Study ID: 111539 Clinical Study ID: 111539 Study Title: A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of scalating Repeat Doses of GSK249320 in Patients With Stroke Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00833989 https://clinicaltrials.gov/ct2/show/NCT00833989 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Refanezumab, Placebo Trade Name: N/A Study Indication: Ischaemic Attack, Transient The study consists of 8 visits: Day 1, Week 1 (Day 5), Week 2 (Day 10), Week 4 (Day 30), Week 8 (Day 60), Week 12 (Day 90), Week 16 (Day 112), Follow-up (F/U). All subjects will receive two doses. The first dose within 24-72 hrs after stroke the second dose 9 +/- 1 days after the first one. Each dose will be given as an intravenous infusion over 60 minutes. This document contains the 12-Lead-ECG form. It has to be filled in for: Day 1, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, early withdrawal, if necessary as unscheduled form as well as for logs/repeats.

End of Trial Phone Check Vital Signs Neurological Status Events Disease Status PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

- 21/02/2017 - 1 Formulaire, 8 Groupes Item, 29 Eléments de données, 1 Langue

Groupes Item: Phone Check Of Patient, Visit, Vital Signs, Neurological Status, Events, New Or Worsening Disease States, ECG, Urinalysis

The purpose of the trial is to determine if extended-release dipyridamole + aspirin [Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis, Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to placebo, in the presence of background antihypertensive therapy, in prevention of a second stroke in patients who have recently suffered a stroke and therefore are at high risk of suffering another one. End of Trial Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00153062?term=NCT00153062&rank=1

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Screening

- 13/10/2020 - 1 Formulaire, 24 Groupes Item, 273 Eléments de données, 1 Langue

Groupes Item: Date of visit, Assessment Date, Trial Screening, Enrollment, Clinical Trial Subject Unique Identifier, Demography, Eligibility Determination, Inclusion, Exclusion Criteria, disease characteristic, disease characteristic, Neoplasm Metastasis, Electrocardiography, Echocardiography; Multiple gated acquisition scanning, Laboratory Procedures, Central Laboratory; Laboratory Procedures, Local, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Central Laboratory, Data, Disease, Operative Surgical Procedures, Disease, Relationships, Disease, Clinical Trials, Therapeutic procedures, Relationships, Disease, Cancer treatment, Prior Therapy, Neurologic Examination, Vital signs, Prior Radiation Therapy, Prior Radiation Therapy, Central Nervous System

Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146 - Follow-Up

- 23/06/2019 - 1 Formulaire, 7 Groupes Item, 36 Eléments de données, 1 Langue

Groupes Item: Administrative documentation, Pregnancy Tests, Vital Signs, Electrocardiography, Laboratory Procedures, Abnormality, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Abnormality, Laboratory Procedures, Urinalysis, Abnormality

Study ID: 102146 Clinical Study ID: SUM102146 Study Title: An open-label, randomized, three-period crossover study to demonstrate the bioequivalence of sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose after dose-normalization, and to assess the relative bioavailability of 4 mg sumatriptan injected using the STATdose device compared to 4 mg sumatriptan injected manually Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061 - Holter ECG Results

- 20/09/2021 - 1 Formulaire, 1 Groupe Item, 79 Eléments de données, 1 Langue

Groupe Item: Holter ECG Results

Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: Holter ECG Results

Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061 - Repeat Telemetry Abnormalities

- 20/09/2021 - 1 Formulaire, 1 Groupe Item, 78 Eléments de données, 1 Langue

Groupe Item: Repeat Telemetry Abnormalities

Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: Repeat Telemetry Abnormalities

Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061 - Telemetry

- 16/05/2018 - 1 Formulaire, 1 Groupe Item, 5 Eléments de données, 1 Langue

Groupe Item: Telemetry

Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: Telemetry

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