ID
44216
Descrição
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.
Palavras-chave
Versões (4)
- 27/02/2018 27/02/2018 -
- 29/01/2019 29/01/2019 - Sarah Riepenhausen
- 13/04/2021 13/04/2021 - Dr. rer. medic Philipp Neuhaus
- 20/09/2021 20/09/2021 -
Titular dos direitos
Prof. Dr. Luisa Klotz
Transferido a
20 de setembro de 2021
DOI
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Licença
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
Descrição
Exclusion criteria
Descrição
hypersensitivity to dimethyl fumarate or any ingredients of Tecfidera
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C0020517 (Hypersensitivity)
- SNOMED
- 421961002
- LOINC
- LP20697-6
- UMLS CUI [1,2]
- C0058218 (dimethyl fumarate)
- SNOMED
- 724035008
Descrição
MS relapse
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0035020 (Relapse)
- SNOMED
- 263855007
Descrição
tuberculosis or active tuberculosis
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0041296 (Tuberculosis)
- SNOMED
- 373576009
- LOINC
- LP28599-6
Descrição
severe impairment of liver function or persisting elevations except patients with confirmed Gilbert´s syndrome (Meulengracht´s disease).
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0232741 (Liver function)
- SNOMED
- 79036002
- LOINC
- LP31397-0
- UMLS CUI [2]
- C0201836 (Alanine aminotransferase measurement)
- SNOMED
- 34608000
- UMLS CUI [3]
- C0201836 (Alanine aminotransferase measurement)
- SNOMED
- 34608000
- UMLS CUI [4]
- C0201899 (Aspartate aminotransferase measurement)
- SNOMED
- 45896001
- UMLS CUI [5]
- C0201916 (Bilirubin, direct measurement)
- SNOMED
- 39748002
- UMLS CUI [6]
- C0017551 (Gilbert Disease (disorder))
- SNOMED
- 27503000
Descrição
serum creatinine
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0201976 (Creatinine measurement, serum (procedure))
- SNOMED
- 113075003
Descrição
Patients with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0018935 (Hematocrit procedure)
- SNOMED
- 28317006
- LOINC
- LP15101-6
- UMLS CUI [2]
- C0518015 (Hemoglobin measurement)
- UMLS CUI [3]
- C0023508 (White Blood Cell Count procedure)
- SNOMED
- 767002
- UMLS CUI [4]
- C0948762 (Absolute neutrophil count)
- UMLS CUI [5]
- C0032181 (Platelet Count measurement)
- SNOMED
- 61928009
- UMLS CUI [6]
- C1254595 (Laboratory Results)
Descrição
Women of childbearing potential not utilizing highly effective contraception
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C3831118 (Childbearing Potential)
- UMLS CUI [2]
- C0700589 (Contraceptive methods)
- SNOMED
- 13197004
Descrição
Mental condition
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C3840291 (Mental condition)
- LOINC
- MTHU047984
Descrição
Patient Non-Compliance
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0376405 (Patient Non-Compliance)
- SNOMED
- 7058009
- LOINC
- LP75189-8
Descrição
Cardiovascular Diseases | nervous system disorder | Endocrine System Diseases | Systemic disease
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0007222 (Cardiovascular Diseases)
- SNOMED
- 49601007
- UMLS CUI [2]
- C0027765 (nervous system disorder)
- SNOMED
- 118940003
- LOINC
- LA10590-0
- UMLS CUI [3]
- C0014130 (Endocrine System Diseases)
- SNOMED
- 362969004
- UMLS CUI [4]
- C0442893 (Systemic disease)
- SNOMED
- 56019007
Descrição
Crohn´s disease
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0010346 (Crohn Disease)
- SNOMED
- 34000006
Descrição
Immunologic Deficiency Syndromes | Malignant Neoplasms | Lymphoproliferative Disorders | Carcinoma, Basosquamous | Lymphatic Irradiation
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0021051 (Immunologic Deficiency Syndromes)
- SNOMED
- 234532001
- LOINC
- MTHU054768
- UMLS CUI [2]
- C0006826 (Malignant Neoplasms)
- SNOMED
- 363346000
- LOINC
- LP100805-3
- UMLS CUI [3]
- C0024314 (Lymphoproliferative Disorders)
- SNOMED
- 84631004
- UMLS CUI [4]
- C0007118 (Carcinoma, Basosquamous)
- SNOMED
- 254702000
- UMLS CUI [5]
- C0024230 (Lymphatic Irradiation)
Descrição
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0019693 (HIV Infections)
- SNOMED
- 86406008
- UMLS CUI [2]
- C0019163 (Hepatitis B)
- SNOMED
- 66071002
- LOINC
- LA18126-5
- UMLS CUI [3]
- C0019196 (Hepatitis C)
- SNOMED
- 50711007
- LOINC
- LA19423-5
Descrição
Acute or chronic infection
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0009450 (Communicable Diseases)
- SNOMED
- 189822004
- UMLS CUI [2]
- C0009450 (Communicable Diseases)
- SNOMED
- 189822004
Descrição
History of drug or alcohol abuse
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0681694 (history of AOD use)
Descrição
Use of adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 4 weeks prior to screening.
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0149783 (Steroid therapy)
- SNOMED
- 297279009
- UMLS CUI [2]
- C0149783 (Steroid therapy)
- SNOMED
- 297279009
Descrição
Cytokine therapy | Immunoglobulins, Intravenous
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0199974 (Cytokine therapy)
- SNOMED
- 84501003
- UMLS CUI [2]
- C0085297 (immunoglobulins, intravenous)
Descrição
Prior use of alemtuzumab or cladribine
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C0383429 (alemtuzumab)
- SNOMED
- 391632007
- UMLS CUI [1,2]
- C2114510 (previous therapy)
- UMLS CUI [2,1]
- C0092801 (cladribine)
- SNOMED
- 108800000
- UMLS CUI [2,2]
- C2114510 (previous therapy)
Descrição
Prior use (within 1 year) of fingolimod (Gilenya®) or natalizumab (Tysabri®).
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C1699926 (fingolimod)
- SNOMED
- 449000008
- UMLS CUI [2]
- C1172734 (natalizumab)
- SNOMED
- 414804006
- UMLS CUI [3,1]
- C2114510 (previous therapy)
- UMLS CUI [3,2]
- C0021079 (Therapeutic immunosuppression)
- SNOMED
- 86553008
Descrição
Mitoxantrone | Azathioprine | Cyclophosphamide | Cyclosporine | Methotrexate | mycophenolate mofetil
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0026259 (mitoxantrone)
- SNOMED
- 108791001
- UMLS CUI [2]
- C0004482 (azathioprine)
- SNOMED
- 111165009
- UMLS CUI [3]
- C0010583 (cyclophosphamide)
- SNOMED
- 74470007
- UMLS CUI [4]
- C0010592 (cyclosporine)
- SNOMED
- 387467008
- UMLS CUI [5]
- C0025677 (methotrexate)
- SNOMED
- 68887009
- UMLS CUI [6]
- C0209368 (mycophenolate mofetil)
- SNOMED
- 386976000
- UMLS CUI [7,1]
- C2114510 (previous therapy)
- UMLS CUI [7,2]
- C0021079 (Therapeutic immunosuppression)
- SNOMED
- 86553008
- UMLS CUI [7,3]
- C0205394 (Other)
- SNOMED
- 74964007
- LOINC
- LP21049-9
Descrição
teriflunomide | leflunomide
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C1718383 (teriflunomide)
- SNOMED
- 703785006
- UMLS CUI [2]
- C0063041 (leflunomide)
- SNOMED
- 109143003
Descrição
Investigational New Drugs
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0013230 (Investigational New Drugs)
Descrição
Patient currently pregnant | Breast Feeding
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0549206 (Patient currently pregnant)
- SNOMED
- 77386006
- LOINC
- LA14670-6
- UMLS CUI [2]
- C0006147 (Breast Feeding)
- SNOMED
- 169741004
- LOINC
- LP420040-0
Descrição
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])
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