ID
12030
Beskrivning
Proof of Concept Study Evaluating RNS60 in the Treatment of Relapsing Remitting Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT01714089 Principal Investigator: Fred Lublin, MD, PhD Mt. Sinai School of Medicine
Länk
https://clinicaltrials.gov/show/NCT01714089
Nyckelord
Versioner (1)
- 2015-09-01 2015-09-01 -
Uppladdad den
1 september 2015
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Relapsing Remitting Multiple Sclerosis NCT01714089
Eligibility Relapsing Remitting Multiple Sclerosis NCT01714089
- StudyEvent: Eligibility
Beskrivning
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251 (Exclusion Criteria)
Beskrivning
1. Diagnosis of Secondary Progressive MS, Primary Progressive MS or Progressive Relapsing MS.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0751965 (Multiple Sclerosis, Secondary Progressive)
- SNOMED
- 425500002
Beskrivning
2.Normal baseline brain MRI.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0412675 (Magnetic resonance imaging of brain and brain stem)
- SNOMED
- 29567006
Beskrivning
3. History of any clinically significant autoimmune disease: inflammatory bowel disease, diabetes, lupus or severe asthma.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0004364 (Autoimmune Diseases)
- SNOMED
- 85828009
Beskrivning
4. Current or prior malignancies (excluding non-melanoma skin carcinoma or in situ carcinoma of the cervix that has been adequately treated.)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0006826 (Malignant Neoplasms)
- SNOMED
- 363346000
- LOINC
- LP100805-3
Beskrivning
5. Significant organ dysfunction, including cardiac, renal (eGFR ≤ 60 ml/min.), liver, central nervous system, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g., creatinine ≥ 1.6 mg/dL; ALT or AST ≥ 1.5x the upper limit of normal), history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to enrollment.the upper limit of normal), history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to enrollment.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0026766 (Multiple Organ Failure)
- SNOMED
- 57653000
Beskrivning
6. Steroid therapy within 60 days prior to enrollment, with the exception of corticosteroids or ACTH for relapse treatment during the course of the study.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0149783 (Steroid therapy)
- SNOMED
- 297279009
Beskrivning
7. Known allergy to Gadolinium-DTPA
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0020517 (Hypersensitivity)
- SNOMED
- 421961002
- LOINC
- LP20697-6
Beskrivning
8. Therapy with any immunomodulatory drugs within 3 months prior to enrollment, including but not limited to interferons, glatiramir acetate, BG-12, teriflunomide, laquinimod and IV immunoglobulin.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3640099 (Immunomodulatory Agent CC-11006)
Beskrivning
9. Treatment at any time with immunosuppressive drugs such as cladribine, total lymphoid irradiation, monoclonal antibody treatment, mitoxantrone, Tysabri, fingolimod, cytoxan, methotrexate.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0021081 (Immunosuppressive Agents)
- SNOMED
- 69431002
Beskrivning
10. Participation in any investigational therapy within one year prior to enrollment, unless given approval by PI.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0679823 (Participation)
Beskrivning
11. Known or suspected current or past alcohol or drug abuse within one year prior to enrollment.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0013146 (Drug abuse)
- SNOMED
- 26416006
- LOINC
- LP36310-8
Beskrivning
12. Any medical, psychiatric or other condition that could result in a subject not being able to comply with protocol requirements.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0205476 (Medical)
- SNOMED
- 74188005
- UMLS CUI [2]
- C0348080 (Condition)
- SNOMED
- 260905004
- LOINC
- LP185404-3
Similar models
Eligibility Relapsing Remitting Multiple Sclerosis NCT01714089
- StudyEvent: Eligibility
C0348080 (UMLS CUI [2])
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