Zoekresultaten - Portaal voor medische datamodellen (MDM-portaal)

PROMESA NCT02008721 - 30 Week control visit (V5)

- 21.12.17 - 1 Formulier, 17 Itemgroepen, 104 Data-elementen, 1 Taal

Itemgroepen: Date of Visit, Medical history, Medical History, Concomitant medication, Vital signs, Physical examination, Physical examination, Neurological examination, Laboratory test, Laboratory test, Unified MSA Rating scale, Unified MSA rating scale, Unified MSA rating scale, Unified MSA rating scale, Clinical Global Impression (CGI), Study medication, Signature of investigator

Double blind, randomised, prospective placebo controlled parallel group phase III study to investigate the effect of EGCG supplementation on disease progression of patients with Multiple System Atrophy (MSA) NCT02008721 Short title: Progression Rate of MSA under EGCG Supplementation as anti-Aggregation-Approach Study Code: PROMESA EudraCT-Number: 2012-000928-18 NCT02008721 Sponsor: Klinikum Großhadern Medical Center University of Munich,Represented by the Medical Director Prof. Dr. med. Burkhard Göke, Marchioninistraße 15 D-81377 Munich Principal Investigator: Prof. Dr. med. Günter Höglinger Department of Neurology, Klinikum rechts der Isar Technische Universität München Ismaninger Str. 22 D-81675 Munich; Contact: Yvonne Rödenbeck Trial Monitoring: Münchner Studienzentrum Klinikum rechts der Isar ,Technische Universität München, Ismaninger Str.22 D-81675 Munich Trial Monitoring: Prof. Dr. rer. nat. Ulrich Masnmann, Institute for Medical Informatics, Biometry and Epidemiology (IBE), Marchioninistraße 15 D-81377 Munich Trial Office: Deutsches Zentrum für Neurodegenerative Erkrankungen e.V., Max-Lebsche Platz 30, D-81377 Munich Source: Priv.-Doz. Dr. med. Johannes Levin Neurologische Klinik Ludwig-Maximilians-Universität München

PROMESA NCT02008721 - 48 Week control visit (V6)

- 21.12.17 - 1 Formulier, 17 Itemgroepen, 104 Data-elementen, 1 Taal

Itemgroepen: Date of Visit, Medical history, Medical History, Concomitant medication, Vital signs, Physical examination, Physical examination, Neurological examination, Laboratory test, Laboratory test, Unified MSA Rating scale, Unified MSA rating scale, Unified MSA rating scale, Unified MSA rating scale, Clinical Global Impression (CGI), Study medication, Signature of investigator

Double blind, randomised, prospective placebo controlled parallel group phase III study to investigate the effect of EGCG supplementation on disease progression of patients with Multiple System Atrophy (MSA) NCT02008721 Short title: Progression Rate of MSA under EGCG Supplementation as anti-Aggregation-Approach Study Code: PROMESA EudraCT-Number: 2012-000928-18 NCT02008721 Sponsor: Klinikum Großhadern Medical Center University of Munich,Represented by the Medical Director Prof. Dr. med. Burkhard Göke, Marchioninistraße 15 D-81377 Munich Principal Investigator: Prof. Dr. med. Günter Höglinger Department of Neurology, Klinikum rechts der Isar Technische Universität München Ismaninger Str. 22 D-81675 Munich; Contact: Yvonne Rödenbeck Trial Monitoring: Münchner Studienzentrum Klinikum rechts der Isar ,Technische Universität München, Ismaninger Str.22 D-81675 Munich Trial Monitoring: Prof. Dr. rer. nat. Ulrich Masnmann, Institute for Medical Informatics, Biometry and Epidemiology (IBE), Marchioninistraße 15 D-81377 Munich Trial Office: Deutsches Zentrum für Neurodegenerative Erkrankungen e.V., Max-Lebsche Platz 30, D-81377 Munich Source: Priv.-Doz. Dr. med. Johannes Levin Neurologische Klinik Ludwig-Maximilians-Universität München

PROMESA NCT02008721 - 12 Week control visit (V4)

- 21.12.17 - 1 Formulier, 11 Itemgroepen, 64 Data-elementen, 1 Taal

Itemgroepen: Date of Visit, Medical history, Concomitant medication, Vital signs, Physical examination, Physical examination, Neurological examination, Laboratory test, Laboratory test, Study medication, Signature of investigator

Double blind, randomised, prospective placebo controlled parallel group phase III study to investigate the effect of EGCG supplementation on disease progression of patients with Multiple System Atrophy (MSA) NCT02008721 Short title: Progression Rate of MSA under EGCG Supplementation as anti-Aggregation-Approach Study Code: PROMESA EudraCT-Number: 2012-000928-18 NCT02008721 Sponsor: Klinikum Großhadern Medical Center University of Munich,Represented by the Medical Director Prof. Dr. med. Burkhard Göke, Marchioninistraße 15 D-81377 Munich Principal Investigator: Prof. Dr. med. Günter Höglinger Department of Neurology, Klinikum rechts der Isar Technische Universität München Ismaninger Str. 22 D-81675 Munich; Contact: Yvonne Rödenbeck Trial Monitoring: Münchner Studienzentrum Klinikum rechts der Isar ,Technische Universität München, Ismaninger Str.22 D-81675 Munich Trial Monitoring: Prof. Dr. rer. nat. Ulrich Masnmann, Institute for Medical Informatics, Biometry and Epidemiology (IBE), Marchioninistraße 15 D-81377 Munich Trial Office: Deutsches Zentrum für Neurodegenerative Erkrankungen e.V., Max-Lebsche Platz 30, D-81377 Munich Source: Priv.-Doz. Dr. med. Johannes Levin Neurologische Klinik Ludwig-Maximilians-Universität München

L-dopa controlled study of ropinirole, neuroprotective effect and ophthalmological safety in early Parkinson’s disease 101468/125 - Module 3 Visit 6 Month 6

- 20.12.17 - 1 Formulier, 18 Itemgroepen, 51 Data-elementen, 1 Taal

Itemgroepen: Current Dose Level, Vital signs, Concomitant Medication, Adverse Experiences, L-Dopa Rescue, Study Medication Compliance, End of visit instructions for patients continuing, End of visit instructions for patients not continuing, ERG Examintion Appointment Card, Concomitant Medication, Details on concomitant medication, Levodopa Rescue Therapy, Details on Levodopa - rescue therapy, Adverse Experiences, Details on Adverse Experiences, Investigator´s Signature, Patient Continuation / Withdrawal, Investigator´s Signature

Study ID: 101468/125 Clinical Study ID: SKF-101468/125 Study Title: A double-blind, multicentre, flexible dose, L-dopa controlled study of ropinirole to investigate A) neuroprotective effect as measured by 3D PET scanning, and B) ophthalmological safety, in patients with early Parkinson’s disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip

PROMESA NCT02008721 - Screening Visit (V0)

- 10.12.17 - 1 Formulier, 30 Itemgroepen, 164 Data-elementen, 1 Taal

Itemgroepen: Screening Visit, Informed consent, Demographic Data, Medical history, Medical History, Multiple System Atrophy History, Psychiatric history, Parkinson's Disease medication, Parkinson's disease medication, Pharmaceutical preparation autonomic dysfunction, Pharmaceutical preparation autonomic dysfunction, Antidepressants and antidementive medication, Antidepressants and antidementive medication, Pharmaceutical Preparation other, Vital signs, Physical examination, Physical examination, Neurological examination, Pregnancy test, Laboratory test, Laboratory test, Diagnosis of probable MSA, Diagnosis of possible MSA , Features supporting (red flags) a diagnosis of MSA, Features not supporting a diagnosis of MSA, MSA Suspected diagnosis, Modified Hoehn and Yahr Staging, Inclusion Criteria, Exclusion criteria, Signature of investigator

Double blind, randomised, prospective placebo controlled parallel group phase III study to investigate the effect of EGCG supplementation on disease progression of patients with Multiple System Atrophy (MSA) NCT02008721 Short title: Progression Rate of MSA under EGCG Supplementation as anti-Aggregation-Approach Study Code: PROMESA EudraCT-Number: 2012-000928-18 NCT02008721 Sponsor: Klinikum Großhadern Medical Center University of Munich,Represented by the Medical Director Prof. Dr. med. Burkhard Göke, Marchioninistraße 15 D-81377 Munich Principal Investigator: Prof. Dr. med. Günter Höglinger Department of Neurology, Klinikum rechts der Isar Technische Universität München Ismaninger Str. 22 D-81675 Munich; Contact: Yvonne Rödenbeck Trial Monitoring: Münchner Studienzentrum Klinikum rechts der Isar ,Technische Universität München, Ismaninger Str.22 D-81675 Munich Trial Monitoring: Prof. Dr. rer. nat. Ulrich Masnmann, Institute for Medical Informatics, Biometry and Epidemiology (IBE), Marchioninistraße 15 D-81377 Munich Trial Office: Deutsches Zentrum für Neurodegenerative Erkrankungen e.V., Max-Lebsche Platz 30, D-81377 Munich Source: Priv.-Doz. Dr. med. Johannes Levin Neurologische Klinik Ludwig-Maximilians-Universität München

Concomitant Medication SirTac NCT02936388 - Concomitant Medication

- 03.12.17 - 1 Formulier, 1 Itemgroep, 12 Data-elementen, 1 Taal

Itemgroep: Concomitant Medication

Study part: Concomitant Medication. A Randomized Phase II Trial of Transarterial Radioembolisation With Yttrium-90 (SIRT) in Comparison to Transarterial Chemoembolisation With Cisplatin (TACE) in Patients With Liver Metastases From Uveal Melanoma. Provided by Prof. Dr. Ulrich Keilholz, Charité – University of medicine Berlin. EudraCT-Nummer: 2014-002439-32. NCT02936388.

Concomitant Therapy GIMEMA CML0408 NCT00769327 - Concomitant Therapy

- 29.11.17 - 1 Formulier, 1 Itemgroep, 4 Data-elementen, 2 Talen

Itemgroep: Concomitant pharmacological therapies

RATIONALE: Nilotinib and imatinib m esylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Concomitant Therapy Form.

Visit 8 GIMEMA CML0408 NCT00769327 - Visit 8

- 29.11.17 - 1 Formulier, 3 Itemgroepen, 28 Data-elementen, 2 Talen

Itemgroepen: Physical Examination, IMATINIB, Complete Blood Count

RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the visit 8 form.

Meningococcal Infections Vaccination in children NCT00196976 - Diary Card Part 2 Booster Vaccination 12-14 months of age

- 08.11.17 - 1 Formulier, 7 Itemgroepen, 64 Data-elementen, 1 Taal

Itemgroepen: Administrative Documentation, Fever, Irritability, Drowsiness, Loss of appetite, Other general symptoms, Medication

Study ID: 103534 Clinical Study ID: 103534 Study Title: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00196976 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: Nimenrix Study Indication: Infections, Meningococcal Booster Vaccination 103534 (MenACWY-TT-011)

Meningococcal Infections Vaccination in children NCT00196976 - Workbook 1 Other medical information

- 08.11.17 - 1 Formulier, 5 Itemgroepen, 16 Data-elementen, 1 Taal

Itemgroepen: Administrative Documentation, Concomitant Vaccination, Concomitant Vaccination, Medication, Medication

Study ID: 103534 Clinical Study ID: 103534 Study Title: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00196976 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: Nimenrix Study Indication: Infections, Meningococcal Booster Vaccination (Only for subjects who are part of the group with the selected MenACWY-TT formulation and the control group.) “Subjects enrolled at 12 – 14 months of age”

Meningococcal Infections Vaccination in children NCT00196976 - Diary Card Part 2 Vaccination 1 3-5 years of age

- 08.11.17 - 1 Formulier, 8 Itemgroepen, 65 Data-elementen, 1 Taal

Itemgroepen: Administrative Documentation, SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS, Fever, Irritability, Drowsiness, Loss of appetite, Other general symptoms, Medication

Study ID: 103533 Clinical Study ID: 103533 Study Title: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00196976 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: Nimenrix Study Indication: Infections, Meningococcal

Meningococcal Infections Vaccination in children NCT00196976 - Diary Card Part 2 Vaccination 2 3-5 years of age