ID
34801
Beschrijving
Screening, Baseline and Visit 1 CRFs of DIMAT-MS and ALAIN studies for semantic analysis of Multiple Sclerosis study documentation. Provided by Prof. Dr. Luisa Klotz of the Department of Neurology of the University Hospital Muenster.
Trefwoorden
Versies (4)
- 27-02-18 27-02-18 -
- 29-01-19 29-01-19 - Sarah Riepenhausen
- 13-04-21 13-04-21 - Dr. rer. medic Philipp Neuhaus
- 20-09-21 20-09-21 -
Houder van rechten
Prof. Dr. Luisa Klotz
Geüploaded op
29 januari 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Multiple sclerosis studies NCT02461069 NCT02419378
Eligibility Medical Examination, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069
- StudyEvent: STUD
- Eligibility Medical Examination, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069
- Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02419378
- Screening: Demography Multiple Sclerosis ALAIN01 NCT02419378
- Screening: EDSS Multiple Sclerosis ALAIN01 NCT02419378
- Screening: Medical History Multiple Sclerosis ALAIN01 NCT02419378
- Screening: MRI Multiple Sclerosis ALAIN01 NCT02419378
- Screening: Vital Signs Multiple Sclerosis ALAIN01 NCT02419378
- Visit 1 (Screening) Part 2/2, Lab; Medical Examination, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069
- Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069
- Baseline: EDSS + Blood sampling Multiple Sclerosis ALAIN01 NCT02419378
- Baseline: Repitition of Assessments EDSS Multiple Sclerosis ALAIN01 NCT02419378
- Baseline: MSFC Multiple Sclerosis ALAIN01 NCT02419378
- Baseline: Repitition of AssessmentsMSFC Multiple Sclerosis ALAIN01 NCT02419378
- Baseline: Evoked Potentials Multiple Sclerosis ALAIN01 NCT02419378
- Baseline: MRI Multiple Sclerosis ALAIN01 NCT02419378
- Baseline: Repitition of Assessments: MRI Multiple Sclerosis ALAIN01 NCT02419378
- Baseline: CSF Multiple Sclerosis ALAIN01 NCT02419378
- Baseline 1st cycle Trial Medication Multiple Sclerosis ALAIN01 NCT02419378
Beschrijving
Exclusion criteria
Beschrijving
hypersensitivity to dimethyl fumarate or any ingredients of Tecfidera
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0058218
Beschrijving
MS relapse
Datatype
boolean
Alias
- UMLS CUI [1]
- C0035020
Beschrijving
tuberculosis or active tuberculosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0041296
Beschrijving
severe impairment of liver function or persisting elevations except patients with confirmed Gilbert´s syndrome (Meulengracht´s disease).
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232741
- UMLS CUI [2]
- C0201836
- UMLS CUI [3]
- C0201836
- UMLS CUI [4]
- C0201899
- UMLS CUI [5]
- C0201916
- UMLS CUI [6]
- C0017551
Beschrijving
serum creatinine
Datatype
boolean
Alias
- UMLS CUI [1]
- C0201976
Beschrijving
Patients with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0018935
- UMLS CUI [2]
- C0518015
- UMLS CUI [3]
- C0023508
- UMLS CUI [4]
- C0948762
- UMLS CUI [5]
- C0032181
- UMLS CUI [6]
- C1254595
Beschrijving
Women of childbearing potential not utilizing highly effective contraception
Datatype
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2]
- C0700589
Beschrijving
Mental condition
Datatype
boolean
Alias
- UMLS CUI [1]
- C3840291
Beschrijving
Patient Non-Compliance
Datatype
boolean
Alias
- UMLS CUI [1]
- C0376405
Beschrijving
Cardiovascular Diseases | nervous system disorder | Endocrine System Diseases | Systemic disease
Datatype
boolean
Alias
- UMLS CUI [1]
- C0007222
- UMLS CUI [2]
- C0027765
- UMLS CUI [3]
- C0014130
- UMLS CUI [4]
- C0442893
Beschrijving
Crohn´s disease
Datatype
boolean
Alias
- UMLS CUI [1]
- C0010346
Beschrijving
Immunologic Deficiency Syndromes | Malignant Neoplasms | Lymphoproliferative Disorders | Carcinoma, Basosquamous | Lymphatic Irradiation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021051
- UMLS CUI [2]
- C0006826
- UMLS CUI [3]
- C0024314
- UMLS CUI [4]
- C0007118
- UMLS CUI [5]
- C0024230
Beschrijving
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Datatype
boolean
Alias
- UMLS CUI [1]
- C0019693
- UMLS CUI [2]
- C0019163
- UMLS CUI [3]
- C0019196
Beschrijving
Acute or chronic infection
Datatype
boolean
Alias
- UMLS CUI [1]
- C0009450
- UMLS CUI [2]
- C0009450
Beschrijving
History of drug or alcohol abuse
Datatype
boolean
Alias
- UMLS CUI [1]
- C0681694
Beschrijving
Use of adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 4 weeks prior to screening.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0149783
- UMLS CUI [2]
- C0149783
Beschrijving
Cytokine therapy | Immunoglobulins, Intravenous
Datatype
boolean
Alias
- UMLS CUI [1]
- C0199974
- UMLS CUI [2]
- C0085297
Beschrijving
Prior use of alemtuzumab or cladribine
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0383429
- UMLS CUI [1,2]
- C2114510
- UMLS CUI [2,1]
- C0092801
- UMLS CUI [2,2]
- C2114510
Beschrijving
Prior use (within 1 year) of fingolimod (Gilenya®) or natalizumab (Tysabri®).
Datatype
boolean
Alias
- UMLS CUI [1]
- C1699926
- UMLS CUI [2]
- C1172734
- UMLS CUI [3,1]
- C2114510
- UMLS CUI [3,2]
- C0021079
Beschrijving
Mitoxantrone | Azathioprine | Cyclophosphamide | Cyclosporine | Methotrexate | mycophenolate mofetil
Datatype
boolean
Alias
- UMLS CUI [1]
- C0026259
- UMLS CUI [2]
- C0004482
- UMLS CUI [3]
- C0010583
- UMLS CUI [4]
- C0010592
- UMLS CUI [5]
- C0025677
- UMLS CUI [6]
- C0209368
- UMLS CUI [7,1]
- C2114510
- UMLS CUI [7,2]
- C0021079
- UMLS CUI [7,3]
- C0205394
Beschrijving
teriflunomide | leflunomide
Datatype
boolean
Alias
- UMLS CUI [1]
- C1718383
- UMLS CUI [2]
- C0063041
Beschrijving
Investigational New Drugs
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013230
Beschrijving
Patient currently pregnant | Breast Feeding
Datatype
boolean
Alias
- UMLS CUI [1]
- C0549206
- UMLS CUI [2]
- C0006147
Beschrijving
Signature Screening Visit 1
Similar models
Eligibility Medical Examination, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069
- StudyEvent: STUD
- Eligibility Medical Examination, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069
- Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02419378
- Screening: Demography Multiple Sclerosis ALAIN01 NCT02419378
- Screening: EDSS Multiple Sclerosis ALAIN01 NCT02419378
- Screening: Medical History Multiple Sclerosis ALAIN01 NCT02419378
- Screening: MRI Multiple Sclerosis ALAIN01 NCT02419378
- Screening: Vital Signs Multiple Sclerosis ALAIN01 NCT02419378
- Visit 1 (Screening) Part 2/2, Lab; Medical Examination, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069
- Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069
- Baseline: EDSS + Blood sampling Multiple Sclerosis ALAIN01 NCT02419378
- Baseline: Repitition of Assessments EDSS Multiple Sclerosis ALAIN01 NCT02419378
- Baseline: MSFC Multiple Sclerosis ALAIN01 NCT02419378
- Baseline: Repitition of AssessmentsMSFC Multiple Sclerosis ALAIN01 NCT02419378
- Baseline: Evoked Potentials Multiple Sclerosis ALAIN01 NCT02419378
- Baseline: MRI Multiple Sclerosis ALAIN01 NCT02419378
- Baseline: Repitition of Assessments: MRI Multiple Sclerosis ALAIN01 NCT02419378
- Baseline: CSF Multiple Sclerosis ALAIN01 NCT02419378
- Baseline 1st cycle Trial Medication Multiple Sclerosis ALAIN01 NCT02419378
C0749659 (UMLS CUI [1,2])
C0058218 (UMLS CUI [1,2])
C0201836 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201916 (UMLS CUI [5])
C0017551 (UMLS CUI [6])
C0518015 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C1254595 (UMLS CUI [6])
C0700589 (UMLS CUI [2])
C0027765 (UMLS CUI [2])
C0014130 (UMLS CUI [3])
C0442893 (UMLS CUI [4])
C0006826 (UMLS CUI [2])
C0024314 (UMLS CUI [3])
C0007118 (UMLS CUI [4])
C0024230 (UMLS CUI [5])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0009450 (UMLS CUI [2])
C0149783 (UMLS CUI [2])
C0085297 (UMLS CUI [2])
C2114510 (UMLS CUI [1,2])
C0092801 (UMLS CUI [2,1])
C2114510 (UMLS CUI [2,2])
C1172734 (UMLS CUI [2])
C2114510 (UMLS CUI [3,1])
C0021079 (UMLS CUI [3,2])
C0004482 (UMLS CUI [2])
C0010583 (UMLS CUI [3])
C0010592 (UMLS CUI [4])
C0025677 (UMLS CUI [5])
C0209368 (UMLS CUI [6])
C2114510 (UMLS CUI [7,1])
C0021079 (UMLS CUI [7,2])
C0205394 (UMLS CUI [7,3])
C0063041 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
C0011008 (UMLS CUI [1,2])