Zoekresultaten - Portaal voor medische datamodellen (MDM-portaal)

Chest X-Ray 2D ECG Effects of Rosiglitazone on Cerebral Glucose Utilization and Cognition in Subjects With Alzheimer's Disease NCT00265148

- 22/05/17 - 1 Formulier, 2 Itemgroepen, 8 Data-elementen, 1 Taal

Itemgroepen: Chest X-Ray, 2D Echocardiogram

A Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) on Cerebral Glucose Utilization and Cognition in Subjects With Mild to Moderate Alzheimer's Disease (AD) Medicine: rosiglitazone, Condition: Alzheimer's Disease, Phase: 2, Clinical Study ID: 49653/461, Sponsor: GSK Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00265148?term=NCT00265148&rank=1

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

- 13/04/21 - 1 Formulier, 6 Itemgroepen, 52 Data-elementen, 1 Taal

Itemgroepen: 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

- 18/12/19 - 1 Formulier, 18 Itemgroepen, 81 Data-elementen, 1 Taal

Itemgroepen: 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

- 15/12/19 - 1 Formulier, 11 Itemgroepen, 40 Data-elementen, 1 Taal

Itemgroepen: 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

- 17/12/19 - 1 Formulier, 19 Itemgroepen, 83 Data-elementen, 1 Taal

Itemgroepen: 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.

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

- 13/10/20 - 1 Formulier, 24 Itemgroepen, 273 Data-elementen, 1 Taal

Itemgroepen: 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

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

- 07/10/19 - 1 Formulier, 8 Itemgroepen, 94 Data-elementen, 1 Taal

Itemgroepen: 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

- 25/09/19 - 1 Formulier, 3 Itemgroepen, 13 Data-elementen, 1 Taal

Itemgroepen: 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.

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Day -1 - 12-Lead ECG; Summary Holter; Summary Holter Abnormalities; Vital Signs; Electronically Transferred Lab Data; Urinalysis; PET; Functional MRI Scan; MRI Scan; Randomisation Number

- 17/09/21 - 1 Formulier, 12 Itemgroepen, 107 Data-elementen, 1 Taal

Itemgroepen: Date of Visit, 12-Lead ECG, Summary Holter, Summary Holter Abnormalities, Vital Signs - Pre-Baseline Scan, Electronically Transerred Lab Data , Urinalysis - Dipstick Details , Urinalysis - Microscopy Details , PET - Scan Baseline, Functional MRI Scan, MRI Scan, Randomisation Number

Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

NINDS CDE Imaging and Non-Imaging Diagnostics Friedreich´s Ataxia - Imaging and Non-Imaging Diagnostics

- 03/05/16 - 1 Formulier, 4 Itemgroepen, 78 Data-elementen, 1 Taal

Itemgroepen: Echocardiogram, Cardiac Magnetic Resonance Imaging, Electrocardiography, Holter exam

NINDS Common Data Elements (Imaging and Non-Imaging Diagnostics; Friedreich´s Ataxia) 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.

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Vital Signs/ Weight/ Physical Examination, Neurological Examination, Electrocardiogram - Baseline Study Week 8

- 08/10/18 - 1 Formulier, 16 Itemgroepen, 56 Data-elementen, 1 Taal

Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Electrocardiogram, Laboratory Comments, Clinical Laboratory Examination, Plasma Samples and the Patient's Clinical Status - Treatment Phase Study Week 18

- 07/04/22 - 1 Formulier, 28 Itemgroepen, 87 Data-elementen, 1 Taal

Itemgroepen: Administrative documentation, Study Subject Participation Status | Assessment Date , Study Subject Participation Status | Clinical Trial Eligibility Criteria, Physical Examination Date, Vital signs | Body Weight, Neurologic Examination; Date in time |On examination - neurological findings , Neurologic Examination | Abnormalities | Mental state, Neurologic Examination; Abnormalities | Speech and language finding, Neurologic Examination; Abnormalities | Cranial Nerves, Neurologic Examination; Abnormalities | Gait, Neurologic Examination | Abnormality | Physiologic Coordination, Neurologic Examination | Abnormality | Esthesia, Neurologic Examination | Abnormality | Muscle strength, Neurologic Examination | Abnormality | Muscle Tonus, Neurologic Examination | Abnormality | Reflex action, Electrocardiography , Laboratory; Specimen collection date , Laboratory test finding , Laboratory Results; Clinical Significance; Unexpected , Laboratory examination; Clinical | Hematology (discipline) , Laboratory examination; Clinical | Chemistry, Clinical , Urinalysis; Urine dipstick test , Serum pregnancy test (B-HCG) , plasma concentration; Antiepileptic Agents, Urine creatinine measurement, Plasma specimen, Clinical status, Clinical status; Finding