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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

  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

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693 (Inclusion)
    1. Males or females, aged between 18 and 50 years.
    Beskrivning

    1. Males or females, aged between 18 and 50 years.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    2. Diagnosis of RR-MS according to McDonald 2010 diagnostic criteria with a prior brain MRI that demonstrates lesions consistent with RRMS, both within the past year.
    Beskrivning

    2. Diagnosis of RR-MS according to McDonald 2010 diagnostic criteria with a prior brain MRI that demonstrates lesions consistent with RRMS, both within the past year.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0751967 (Multiple Sclerosis, Relapsing-Remitting)
    SNOMED
    426373005
    3.No evidence of relapse during the 60 days prior to enrollment.
    Beskrivning

    3.No evidence of relapse during the 60 days prior to enrollment.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0035020 (Relapse)
    SNOMED
    263855007
    4. EDSS score of 0-5 at screening.
    Beskrivning

    4. EDSS score of 0-5 at screening.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0451246 (Kurtzke multiple sclerosis rating scale)
    SNOMED
    273554001
    5. Women of childbearing potential who have a negative pregnancy test (serum HCG) at screening.
    Beskrivning

    5. Women of childbearing potential who have a negative pregnancy test (serum HCG) at screening.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0427780 (Pregnancy test negative)
    SNOMED
    250425007
    6. Men or women of reproductive potential who commit to use adequate contraception during the study and for 1 month following the last day of treatment.
    Beskrivning

    6. Men or women of reproductive potential who commit to use adequate contraception during the study and for 1 month following the last day of treatment.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    7. Subjects must be capable of understanding the purpose and risks of the study and provide written, informed consent.
    Beskrivning

    7. Subjects must be capable of understanding the purpose and risks of the study and provide written, informed consent.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251 (Exclusion Criteria)
    1. Diagnosis of Secondary Progressive MS, Primary Progressive MS or Progressive Relapsing MS.
    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
    2.Normal baseline brain MRI.
    Beskrivning

    2.Normal baseline brain MRI.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0412675 (Magnetic resonance imaging of brain and brain stem)
    SNOMED
    29567006
    3. History of any clinically significant autoimmune disease: inflammatory bowel disease, diabetes, lupus or severe asthma.
    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
    4. Current or prior malignancies (excluding non-melanoma skin carcinoma or in situ carcinoma of the cervix that has been adequately treated.)
    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
    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.
    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
    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.
    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
    7. Known allergy to Gadolinium-DTPA
    Beskrivning

    7. Known allergy to Gadolinium-DTPA

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    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.
    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)
    9. Treatment at any time with immunosuppressive drugs such as cladribine, total lymphoid irradiation, monoclonal antibody treatment, mitoxantrone, Tysabri, fingolimod, cytoxan, methotrexate.
    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
    10. Participation in any investigational therapy within one year prior to enrollment, unless given approval by PI.
    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)
    11. Known or suspected current or past alcohol or drug abuse within one year prior to enrollment.
    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
    12. Any medical, psychiatric or other condition that could result in a subject not being able to comply with protocol requirements.
    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

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    age
    Item
    1. Males or females, aged between 18 and 50 years.
    boolean
    C0001779 (UMLS CUI [1])
    Relapsing Remitting Multiple Sclerosis
    Item
    2. Diagnosis of RR-MS according to McDonald 2010 diagnostic criteria with a prior brain MRI that demonstrates lesions consistent with RRMS, both within the past year.
    boolean
    C0751967 (UMLS CUI [1])
    relapse
    Item
    3.No evidence of relapse during the 60 days prior to enrollment.
    boolean
    C0035020 (UMLS CUI [1])
    edss score
    Item
    4. EDSS score of 0-5 at screening.
    boolean
    C0451246 (UMLS CUI [1])
    Pregnancy test negative
    Item
    5. Women of childbearing potential who have a negative pregnancy test (serum HCG) at screening.
    boolean
    C0427780 (UMLS CUI [1])
    contraception
    Item
    6. Men or women of reproductive potential who commit to use adequate contraception during the study and for 1 month following the last day of treatment.
    boolean
    C0700589 (UMLS CUI [1])
    informed consent
    Item
    7. Subjects must be capable of understanding the purpose and risks of the study and provide written, informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    Secondary Progressive MS
    Item
    1. Diagnosis of Secondary Progressive MS, Primary Progressive MS or Progressive Relapsing MS.
    boolean
    C0751965 (UMLS CUI [1])
    brain mri
    Item
    2.Normal baseline brain MRI.
    boolean
    C0412675 (UMLS CUI [1])
    autoimmune disease
    Item
    3. History of any clinically significant autoimmune disease: inflammatory bowel disease, diabetes, lupus or severe asthma.
    boolean
    C0004364 (UMLS CUI [1])
    malignancies
    Item
    4. Current or prior malignancies (excluding non-melanoma skin carcinoma or in situ carcinoma of the cervix that has been adequately treated.)
    boolean
    C0006826 (UMLS CUI [1])
    Multiple Organ Failure
    Item
    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.
    boolean
    C0026766 (UMLS CUI [1])
    Steroid therapy
    Item
    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.
    boolean
    C0149783 (UMLS CUI [1])
    allergy
    Item
    7. Known allergy to Gadolinium-DTPA
    boolean
    C0020517 (UMLS CUI [1])
    immunomodulatory drugs
    Item
    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.
    boolean
    C3640099 (UMLS CUI [1])
    immunosuppressive agent
    Item
    9. Treatment at any time with immunosuppressive drugs such as cladribine, total lymphoid irradiation, monoclonal antibody treatment, mitoxantrone, Tysabri, fingolimod, cytoxan, methotrexate.
    boolean
    C0021081 (UMLS CUI [1])
    Participation
    Item
    10. Participation in any investigational therapy within one year prior to enrollment, unless given approval by PI.
    boolean
    C0679823 (UMLS CUI [1])
    drug abuse
    Item
    11. Known or suspected current or past alcohol or drug abuse within one year prior to enrollment.
    boolean
    C0013146 (UMLS CUI [1])
    medical; condition
    Item
    12. Any medical, psychiatric or other condition that could result in a subject not being able to comply with protocol requirements.
    boolean
    C0205476 (UMLS CUI [1])
    C0348080 (UMLS CUI [2])

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