0 Avaliações

ID

18295

Descrição

Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis Attacks; ODM derived from: https://clinicaltrials.gov/show/NCT00418145

Link

https://clinicaltrials.gov/show/NCT00418145

Palavras-chave

  1. 28/10/2016 28/10/2016 -
Transferido a

28 de outubro de 2016

DOI

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Licença

Creative Commons BY 4.0

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    Eligibility Multiple Sclerosis NCT00418145

    Eligibility Multiple Sclerosis NCT00418145

    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    between the ages of 18 and 50 years, inclusive.
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    acute symptomatic exacerbation of ms present for great than 24 hours and less than or equal to 7 days at entry with new or worsening symptoms, and with signs referable to the symptoms; in the absence of a fever or active infection.
    Descrição

    Multiple Sclerosis Worsening Symptomatic | New or Worsening Symptom | Fever Absent | Communicable Disease Absent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0026769
    UMLS CUI [1,2]
    C0332271
    UMLS CUI [1,3]
    C0231220
    UMLS CUI [2]
    C3898139
    UMLS CUI [3,1]
    C0015967
    UMLS CUI [3,2]
    C0332197
    UMLS CUI [4,1]
    C0009450
    UMLS CUI [4,2]
    C0332197
    diagnosis of a relapsing form of multiple sclerosis before randomization as determined by poser or mcdonald criteria.
    Descrição

    Multiple Sclerosis, Acute Relapsing

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0393664
    expanded disability status scale (edss) score between 2 and 6.5, inclusive at entry.
    Descrição

    EDSS

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0451246
    episodes include study neurologist or neuro-ophthalmologist diagnosed: acute optic neuritis, cerebellar, brainstem dysfunction, myelitis, focal cerebral, and/or definitive focal sensory dysfunction.
    Descrição

    Optic Neuritis | Cerebellar Diseases | Brain Stem Dysfunction | Myelitis | brain dysfunction Focal | Dysfunction Sensory Focal

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0029134
    UMLS CUI [2]
    C0007760
    UMLS CUI [3,1]
    C0006121
    UMLS CUI [3,2]
    C3887504
    UMLS CUI [4]
    C0026975
    UMLS CUI [5,1]
    C0262405
    UMLS CUI [5,2]
    C0205234
    UMLS CUI [6,1]
    C3887504
    UMLS CUI [6,2]
    C0445254
    UMLS CUI [6,3]
    C0205234
    new objective clinical finding other than a sensory exacerbation, or bowel/bladder signs alone. sensory deficits alone will not qualify except for optic neuritis.
    Descrição

    Signs and Symptoms New | Worsening Sensory | Intestines Signs and Symptoms | Bladder Signs and Symptoms | Optic Neuritis

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C0205314
    UMLS CUI [2,1]
    C0332271
    UMLS CUI [2,2]
    C0445254
    UMLS CUI [3,1]
    C0021853
    UMLS CUI [3,2]
    C0037088
    UMLS CUI [4,1]
    C0005682
    UMLS CUI [4,2]
    C0037088
    UMLS CUI [5]
    C0029134
    subjects may continue on their current immunomodulating therapy (such as interferons or glatiramer acetate) throughout the course of the study. women who become pregnant after the 5-day treatment of steroids should discontinue immunomodulatory treatment.
    Descrição

    Immunomodulation | Interferons | glatiramer acetate | Pregnancy Immunomodulation To be stopped

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1963758
    UMLS CUI [2]
    C0021747
    UMLS CUI [3]
    C0289884
    UMLS CUI [4,1]
    C0032961
    UMLS CUI [4,2]
    C1963758
    UMLS CUI [4,3]
    C1272691
    understand and sign written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.
    Descrição

    Informed Consent | Screening test | Evaluation

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2]
    C0871311
    UMLS CUI [3]
    C1261322
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    any patients treated with systemic corticosteroid use within one month of the index episode at screening.
    Descrição

    Systemic Corticosteroid Therapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C4053960
    prior use of immunosuppressive treatments within 90 days of index episode (mitoxantrone, azathioprine, ivig) or plasmapheresis.
    Descrição

    Therapeutic immunosuppression | Mitoxantrone | Azathioprine | Immunoglobulins, Intravenous | Plasmapheresis

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021079
    UMLS CUI [2]
    C0026259
    UMLS CUI [3]
    C0004482
    UMLS CUI [4]
    C0085297
    UMLS CUI [5]
    C0032134
    any patient who is pregnant or breastfeeding.
    Descrição

    Pregnancy | Breast Feeding

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    unable to perform the multiple sclerosis functional composite consisting of: timed 25-foot walk, 9-hole peg test, and paced auditory serial addition test (3 second).
    Descrição

    Multiple Sclerosis Test Functional | Timed 25-Foot Walk Functional Test Unable | Time to Complete 9-Hole Peg Test Unable | Paced auditory serial addition test Unable

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0026769
    UMLS CUI [1,2]
    C0392366
    UMLS CUI [1,3]
    C0205245
    UMLS CUI [2,1]
    C3897356
    UMLS CUI [2,2]
    C1299582
    UMLS CUI [3,1]
    C3898195
    UMLS CUI [3,2]
    C1299582
    UMLS CUI [4,1]
    C0589060
    UMLS CUI [4,2]
    C1299582
    peripheral or cranial neuropathy as sole problem of acute episode.
    Descrição

    Peripheral Neuropathy | Cranial nerve diseases

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0031117
    UMLS CUI [2]
    C0010266
    history of any significant cardiac, gastrointestinal, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude corticosteroid therapy.
    Descrição

    Heart Disease Significant | Gastrointestinal Disease Significant | Liver disease Significant | Lung disease Significant | Kidney Disease Significant | Immune Deficiency Disease | Medical condition Excludes Steroid therapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0018799
    UMLS CUI [1,2]
    C0750502
    UMLS CUI [2,1]
    C0017178
    UMLS CUI [2,2]
    C0750502
    UMLS CUI [3,1]
    C0023895
    UMLS CUI [3,2]
    C0750502
    UMLS CUI [4,1]
    C0024115
    UMLS CUI [4,2]
    C0750502
    UMLS CUI [5,1]
    C0022658
    UMLS CUI [5,2]
    C0750502
    UMLS CUI [6]
    C1855771
    UMLS CUI [7,1]
    C3843040
    UMLS CUI [7,2]
    C0332196
    UMLS CUI [7,3]
    C0149783
    primary progressive multiple sclerosis (ppms).
    Descrição

    Multiple Sclerosis, Primary Progressive

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0751964
    previous participation in this study.
    Descrição

    Study Subject Participation Status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2348568

    Similar models

    Eligibility Multiple Sclerosis NCT00418145

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    between the ages of 18 and 50 years, inclusive.
    boolean
    C0001779 (UMLS CUI [1])
    Multiple Sclerosis Worsening Symptomatic | New or Worsening Symptom | Fever Absent | Communicable Disease Absent
    Item
    acute symptomatic exacerbation of ms present for great than 24 hours and less than or equal to 7 days at entry with new or worsening symptoms, and with signs referable to the symptoms; in the absence of a fever or active infection.
    boolean
    C0026769 (UMLS CUI [1,1])
    C0332271 (UMLS CUI [1,2])
    C0231220 (UMLS CUI [1,3])
    C3898139 (UMLS CUI [2])
    C0015967 (UMLS CUI [3,1])
    C0332197 (UMLS CUI [3,2])
    C0009450 (UMLS CUI [4,1])
    C0332197 (UMLS CUI [4,2])
    Multiple Sclerosis, Acute Relapsing
    Item
    diagnosis of a relapsing form of multiple sclerosis before randomization as determined by poser or mcdonald criteria.
    boolean
    C0393664 (UMLS CUI [1])
    EDSS
    Item
    expanded disability status scale (edss) score between 2 and 6.5, inclusive at entry.
    boolean
    C0451246 (UMLS CUI [1])
    Optic Neuritis | Cerebellar Diseases | Brain Stem Dysfunction | Myelitis | brain dysfunction Focal | Dysfunction Sensory Focal
    Item
    episodes include study neurologist or neuro-ophthalmologist diagnosed: acute optic neuritis, cerebellar, brainstem dysfunction, myelitis, focal cerebral, and/or definitive focal sensory dysfunction.
    boolean
    C0029134 (UMLS CUI [1])
    C0007760 (UMLS CUI [2])
    C0006121 (UMLS CUI [3,1])
    C3887504 (UMLS CUI [3,2])
    C0026975 (UMLS CUI [4])
    C0262405 (UMLS CUI [5,1])
    C0205234 (UMLS CUI [5,2])
    C3887504 (UMLS CUI [6,1])
    C0445254 (UMLS CUI [6,2])
    C0205234 (UMLS CUI [6,3])
    Signs and Symptoms New | Worsening Sensory | Intestines Signs and Symptoms | Bladder Signs and Symptoms | Optic Neuritis
    Item
    new objective clinical finding other than a sensory exacerbation, or bowel/bladder signs alone. sensory deficits alone will not qualify except for optic neuritis.
    boolean
    C0037088 (UMLS CUI [1,1])
    C0205314 (UMLS CUI [1,2])
    C0332271 (UMLS CUI [2,1])
    C0445254 (UMLS CUI [2,2])
    C0021853 (UMLS CUI [3,1])
    C0037088 (UMLS CUI [3,2])
    C0005682 (UMLS CUI [4,1])
    C0037088 (UMLS CUI [4,2])
    C0029134 (UMLS CUI [5])
    Immunomodulation | Interferons | glatiramer acetate | Pregnancy Immunomodulation To be stopped
    Item
    subjects may continue on their current immunomodulating therapy (such as interferons or glatiramer acetate) throughout the course of the study. women who become pregnant after the 5-day treatment of steroids should discontinue immunomodulatory treatment.
    boolean
    C1963758 (UMLS CUI [1])
    C0021747 (UMLS CUI [2])
    C0289884 (UMLS CUI [3])
    C0032961 (UMLS CUI [4,1])
    C1963758 (UMLS CUI [4,2])
    C1272691 (UMLS CUI [4,3])
    Informed Consent | Screening test | Evaluation
    Item
    understand and sign written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.
    boolean
    C0021430 (UMLS CUI [1])
    C0871311 (UMLS CUI [2])
    C1261322 (UMLS CUI [3])
    Item Group
    C0680251 (UMLS CUI)
    Systemic Corticosteroid Therapy
    Item
    any patients treated with systemic corticosteroid use within one month of the index episode at screening.
    boolean
    C4053960 (UMLS CUI [1])
    Therapeutic immunosuppression | Mitoxantrone | Azathioprine | Immunoglobulins, Intravenous | Plasmapheresis
    Item
    prior use of immunosuppressive treatments within 90 days of index episode (mitoxantrone, azathioprine, ivig) or plasmapheresis.
    boolean
    C0021079 (UMLS CUI [1])
    C0026259 (UMLS CUI [2])
    C0004482 (UMLS CUI [3])
    C0085297 (UMLS CUI [4])
    C0032134 (UMLS CUI [5])
    Pregnancy | Breast Feeding
    Item
    any patient who is pregnant or breastfeeding.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Multiple Sclerosis Test Functional | Timed 25-Foot Walk Functional Test Unable | Time to Complete 9-Hole Peg Test Unable | Paced auditory serial addition test Unable
    Item
    unable to perform the multiple sclerosis functional composite consisting of: timed 25-foot walk, 9-hole peg test, and paced auditory serial addition test (3 second).
    boolean
    C0026769 (UMLS CUI [1,1])
    C0392366 (UMLS CUI [1,2])
    C0205245 (UMLS CUI [1,3])
    C3897356 (UMLS CUI [2,1])
    C1299582 (UMLS CUI [2,2])
    C3898195 (UMLS CUI [3,1])
    C1299582 (UMLS CUI [3,2])
    C0589060 (UMLS CUI [4,1])
    C1299582 (UMLS CUI [4,2])
    Peripheral Neuropathy | Cranial nerve diseases
    Item
    peripheral or cranial neuropathy as sole problem of acute episode.
    boolean
    C0031117 (UMLS CUI [1])
    C0010266 (UMLS CUI [2])
    Heart Disease Significant | Gastrointestinal Disease Significant | Liver disease Significant | Lung disease Significant | Kidney Disease Significant | Immune Deficiency Disease | Medical condition Excludes Steroid therapy
    Item
    history of any significant cardiac, gastrointestinal, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude corticosteroid therapy.
    boolean
    C0018799 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    C0017178 (UMLS CUI [2,1])
    C0750502 (UMLS CUI [2,2])
    C0023895 (UMLS CUI [3,1])
    C0750502 (UMLS CUI [3,2])
    C0024115 (UMLS CUI [4,1])
    C0750502 (UMLS CUI [4,2])
    C0022658 (UMLS CUI [5,1])
    C0750502 (UMLS CUI [5,2])
    C1855771 (UMLS CUI [6])
    C3843040 (UMLS CUI [7,1])
    C0332196 (UMLS CUI [7,2])
    C0149783 (UMLS CUI [7,3])
    Multiple Sclerosis, Primary Progressive
    Item
    primary progressive multiple sclerosis (ppms).
    boolean
    C0751964 (UMLS CUI [1])
    Study Subject Participation Status
    Item
    previous participation in this study.
    boolean
    C2348568 (UMLS CUI [1])

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