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Table of contents
  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
    1. 7.1. Anesthesiology
    1. 7.2. Dermatology
    1. 7.3. ENT
    1. 7.4. Geriatrics
    1. 7.5. Gynecology/Obstetrics
    1. 7.6. Internal Medicine
      1. Hematology
      1. Infectious Diseases
      1. Cardiology/Angiology
      1. Pneumology
      1. Gastroenterology
      1. Nephrology
      1. Endocrinology/Metabolic Diseases
      1. Rheumatology
    1. 7.7. Neurology
    1. 7.8. Ophthalmology
    1. 7.9. Palliative Care
    1. 7.10. Pathology/Forensics
    1. 7.11. Pediatrics
    1. 7.12. Psychiatry/Psychosomatics
    1. 7.13. Radiology
    1. 7.14. Surgery
      1. General/Visceral Surgery
      1. Neurosurgery
      1. Plastic Surgery
      1. Thoracic Surgery
      1. Trauma/Orthopedics
      1. Vascular Surgery
    1. 7.15. Urology
    1. 7.16. Dental Medicine/OMS
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NINDS CDE MRI Multiple Sclerosis - MRI

- 6/29/16 - 1 form, 1 itemgroup, 19 items, 1 language
Itemgroup: MRI
NINDS Common Data Elements, Multiple Sclerosis MRI 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.

Screening: MRI Multiple Sclerosis ALAIN01 NCT02419378

- 6/3/16 - 1 form, 1 itemgroup, 16 items, 1 language
Itemgroup: 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

Baseline: MRI Multiple Sclerosis ALAIN01 NCT02419378

- 6/3/16 - 1 form, 1 itemgroup, 15 items, 1 language
Itemgroup: 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.

Discontinuation Visit: MRI Multiple Sclerosis ALAIN01 NCT02419378

- 6/3/16 - 1 form, 1 itemgroup, 14 items, 1 language
Itemgroup: 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: Discontinuation Visit

Month 36: MRI Multiple Sclerosis ALAIN01 NCT02419378

- 6/3/16 - 1 form, 1 itemgroup, 14 items, 1 language
Itemgroup: 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: Month 36

Month 12: MRI Multiple Sclerosis ALAIN01 NCT02419378

- 6/3/16 - 1 form, 1 itemgroup, 14 items, 1 language
Itemgroup: 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: Month 12

Month 18: MRI Multiple Sclerosis ALAIN01 NCT02419378

- 6/3/16 - 1 form, 1 itemgroup, 14 items, 1 language
Itemgroup: 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: Month 18

Month 30: MRI Multiple Sclerosis ALAIN01 NCT02419378

- 6/3/16 - 1 form, 1 itemgroup, 14 items, 1 language
Itemgroup: 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: Month 30

Month 24: MRI Multiple Sclerosis ALAIN01 NCT02419378

- 6/3/16 - 1 form, 1 itemgroup, 14 items, 1 language
Itemgroup: 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: Month 24

Month 6: MRI Multiple Sclerosis ALAIN01 NCT02419378

- 6/3/16 - 1 form, 1 itemgroup, 14 items, 1 language
Itemgroup: 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: Month 6

Baseline: Repitition of Assessments: MRI Multiple Sclerosis ALAIN01 NCT02419378

- 6/3/16 - 1 form, 1 itemgroup, 15 items, 1 language
Itemgroup: 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: Repitition of Assessments If already performed at screening, please enter results of screening MRI.

MRI Site Evaluation MS Diagnostic Criteria CRFs Multiple Sclerosis Tysabri NCT00027300

- 1/30/17 - 1 form, 2 itemgroups, 7 items, 1 language
Itemgroups: MRI Evaluation: Site Screening Documentation, MS Diagnostic Criteria
The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS. Documentation process: This form is to be obtained in Screening.

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