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

CHEST X-RAY (AP AND LATERAL) Roche H0650g Breast Cancer - CHEST X-RAY (AP AND LATERAL)

- 16-05-17 - 1 Formulaire, 1 Groupe Item, 5 Eléments de données, 1 Langue

Groupe Item: Chest X-Ray

Study part: Chest X- ray. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

STUDY TERMINATION CHEST X-RAY (AP AND LATERAL) Roche H0650g Breast Cancer - STUDY TERMINATION CHEST X-RAY (AP AND LATERAL)

- 20-05-17 - 1 Formulaire, 1 Groupe Item, 5 Eléments de données, 1 Langue

Groupe Item: Chest X-Ray

Study part: Study Termination Chest X- ray. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

Melanoma (Skin) null Registration - Chest X-ray Report Shuttle (CXRS) - 2074545v3.0 - Chest X-ray Report Shuttle (CXRS)

- 09-01-15 - 1 Formulaire, 1 Groupe Item, 4 Eléments de données, 1 Langue

Groupe Item: CCRR MODULE

Chest X-ray Report Shuttle (CXRS) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1232AA1-F528-4C83-E034-0003BA12F5E7

Eligibility Inflammatory Arthritis NCT00808496

- 07-05-18 - 1 Formulaire, 2 Groupes Item, 15 Eléments de données, 1 Langue

Groupes Item: Inclusion Criteria, Exclusion Criteria

The Effect of Biannual Monitoring With Magnetic Resonance Imaging (MRI), X-ray, or Usual Care on Treatment for Inflammatory Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00808496

Preoperative MRI of Prostate Cancer NCT01347320 - Eligibility

- 29-05-19 - 1 Formulaire, 2 Groupes Item, 9 Eléments de données, 1 Langue

Groupes Item: Inclusion Criteria, Exclusion Criteria

Preoperative Magnetic Resonance (MR) Imaging of Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01347320

Baseline MRI Visit 08 SirTac NCT02936388 - Baseline MRI Visit 08

- 26-11-17 - 1 Formulaire, 3 Groupes Item, 20 Eléments de données, 1 Langue

Groupes Item: Baseline MRI, location liver, Non-target Lesions

Study part: Baseline MRI Visit 08. 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.

Baseline MRI Visit 06 SirTac NCT02936388 - Baseline MRI Visit 06

- 26-11-17 - 1 Formulaire, 3 Groupes Item, 20 Eléments de données, 1 Langue

Groupes Item: Baseline MRI, location liver, Non-target Lesions

Study part: Baseline MRI Visit 06. 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.

Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026 - X Ray Pneumonia Confirmation (X-ray)

- 08-01-19 - 1 Formulaire, 2 Groupes Item, 3 Eléments de données, 1 Langue

Groupes Item: Administrative data, X Ray Pneumonia Confirmation (X-ray)

Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 4 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains the X Ray Pneumonia Confirmation (X-ray) form. It has to be filled in for each x-ray for pneumonia confirmation performed during trial, if necessary.

Baseline: MRI Multiple Sclerosis ALAIN01 NCT02419378

- 03-06-16 - 1 Formulaire, 1 Groupe Item, 15 Eléments de données, 1 Langue

Groupe Item: MRI

Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential (ALAIN01) https://clinicaltrials.gov/ct2/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany Part: Baseline If already performed at screening, please enter results of screening MRI.

Screening: MRI Multiple Sclerosis ALAIN01 NCT02419378

- 03-06-16 - 1 Formulaire, 1 Groupe Item, 16 Eléments de données, 1 Langue

Groupe Item: MRI

Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential (ALAIN01) https://clinicaltrials.gov/ct2/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany Part: Screening

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - CT Assessment

- 22-02-21 - 1 Formulaire, 3 Groupes Item, 11 Eléments de données, 1 Langue

Groupes Item: Administrative Data, CT Assessment Questions, Lymph Node CT Assessments

Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. Both of these forms have to be filled out at the observation visits for the cycles of treatment and possible unscheduled visits. The Lymph Node CT Assessments form also has to be filled out at a possible withdrawal visit.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - CT Imaging

- 10-02-21 - 1 Formulaire, 3 Groupes Item, 13 Eléments de données, 1 Langue

Groupes Item: Administrative Data, CT Organ Exam, Lymph node CT screening assessments

Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. The CT Organ exam form has to be filled out at the screening visit, cycle 1 and 2 observation visits and possible unscheduled visits. The CT Lymphnode Screening only has to be filled out at screening.

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