ID
12030
Descrizione
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
collegamento
https://clinicaltrials.gov/show/NCT01714089
Keywords
versioni (1)
- 01/09/15 01/09/15 -
Caricato su
1 settembre 2015
DOI
Per favore, per richiedere un accesso.
Licenza
Creative Commons BY 4.0
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Eligibility Relapsing Remitting Multiple Sclerosis NCT01714089
Eligibility Relapsing Remitting Multiple Sclerosis NCT01714089
- StudyEvent: Eligibility
Descrizione
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Descrizione
1. Diagnosis of Secondary Progressive MS, Primary Progressive MS or Progressive Relapsing MS.
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0751965
Descrizione
2.Normal baseline brain MRI.
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0412675
Descrizione
3. History of any clinically significant autoimmune disease: inflammatory bowel disease, diabetes, lupus or severe asthma.
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0004364
Descrizione
4. Current or prior malignancies (excluding non-melanoma skin carcinoma or in situ carcinoma of the cervix that has been adequately treated.)
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0006826
Descrizione
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.
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0026766
Descrizione
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.
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0149783
Descrizione
7. Known allergy to Gadolinium-DTPA
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0020517
Descrizione
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.
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C3640099
Descrizione
9. Treatment at any time with immunosuppressive drugs such as cladribine, total lymphoid irradiation, monoclonal antibody treatment, mitoxantrone, Tysabri, fingolimod, cytoxan, methotrexate.
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0021081
Descrizione
10. Participation in any investigational therapy within one year prior to enrollment, unless given approval by PI.
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0679823
Descrizione
11. Known or suspected current or past alcohol or drug abuse within one year prior to enrollment.
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0013146
Descrizione
12. Any medical, psychiatric or other condition that could result in a subject not being able to comply with protocol requirements.
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0205476
- UMLS CUI [2]
- C0348080
Similar models
Eligibility Relapsing Remitting Multiple Sclerosis NCT01714089
- StudyEvent: Eligibility
C0348080 (UMLS CUI [2])