ID

17150

Beskrivning

A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52 Antibody) Therapy in Newly Diagnosed Subjects With Type 1 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00214214

Länk

https://clinicaltrials.gov/show/NCT00214214

Nyckelord

  1. 2016-08-28 2016-08-28 -
Uppladdad den

28 augusti 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility New Onset Type 1 Diabetes Mellitus NCT00214214

    Eligibility New Onset Type 1 Diabetes Mellitus NCT00214214

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    adult subjects ages 18-35, with new onset type 1 diabetes mellitus (within 2-12 weeks of diagnosis), one or more islet autoantibody to gad, ia2, iaa or islet cell cytoplasmic antibody (ica) within 2 weeks of diabetes diagnosis.
    Beskrivning

    Age, Diabetes Mellitus Type I

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C0011854
    UMLS CUI [3]
    C1167897
    UMLS CUI [4]
    C3203592
    UMLS CUI [5]
    C1275890
    UMLS CUI [6]
    C0063900
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    subjects under 18 years of age or over 35 years of age.
    Beskrivning

    Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    subjects who have previously received an organ transplant.
    Beskrivning

    Organ transplant

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0029216
    subjects who are currently receiving systemic corticosteroids for other medical diseases in which the physician feels discontinuation of corticosteroids is contraindicated.
    Beskrivning

    Systemic corticosteroids

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2825233
    subjects with a history of other medical condition(s) known to affect blood glucose values (i.e., cushing's disease, acromegaly).
    Beskrivning

    Other medical condition(s) known to affect blood glucose values

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0005802
    subjects with a history of other chronic systemic inflammatory or autoimmune disease or other severe medical condition. (a history of treated hypothyroidism with documentation of normal serum thyroid hormone levels will not be exclusionary.)
    Beskrivning

    Chronic systemic inflammatory or autoimmune disease or other severe medical condition

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1290884
    UMLS CUI [2]
    C0004364
    UMLS CUI [3]
    C0009488
    patients with a history of hepatitis b, hepatitis c, or hiv.
    Beskrivning

    Hepatitis B, Hepatitis C, or HIV

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019163
    UMLS CUI [2]
    C0019196
    UMLS CUI [3]
    C0019693
    ppd positive at the time of evaluation.
    Beskrivning

    PPD positive

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032739
    thrombocytopenia or neutropenia. individuals will be considered to have thrombocytopenia if they have a platelet count <100,000 platelets/mm2 or <3,000 wbc/ml.
    Beskrivning

    Thrombocytopenia or neutropenia

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032181
    UMLS CUI [2]
    C0023508
    subjects with a history of renal, pulmonary, or cardiac failure
    Beskrivning

    Renal, pulmonary, or cardiac failure

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0035078
    UMLS CUI [2]
    C0948755
    UMLS CUI [3]
    C0018801
    subjects with severe systemic infections. only those subjects who have completed treatment and have shown a complete clinical resolution will be considered eligible for the study.
    Beskrivning

    Infection

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0009450

    Similar models

    Eligibility New Onset Type 1 Diabetes Mellitus NCT00214214

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age, Diabetes Mellitus Type I
    Item
    adult subjects ages 18-35, with new onset type 1 diabetes mellitus (within 2-12 weeks of diagnosis), one or more islet autoantibody to gad, ia2, iaa or islet cell cytoplasmic antibody (ica) within 2 weeks of diabetes diagnosis.
    boolean
    C0001779 (UMLS CUI [1])
    C0011854 (UMLS CUI [2])
    C1167897 (UMLS CUI [3])
    C3203592 (UMLS CUI [4])
    C1275890 (UMLS CUI [5])
    C0063900 (UMLS CUI [6])
    Item Group
    C0680251 (UMLS CUI)
    Age
    Item
    subjects under 18 years of age or over 35 years of age.
    boolean
    C0001779 (UMLS CUI [1])
    Organ transplant
    Item
    subjects who have previously received an organ transplant.
    boolean
    C0029216 (UMLS CUI [1])
    Systemic corticosteroids
    Item
    subjects who are currently receiving systemic corticosteroids for other medical diseases in which the physician feels discontinuation of corticosteroids is contraindicated.
    boolean
    C2825233 (UMLS CUI [1])
    Other medical condition(s) known to affect blood glucose values
    Item
    subjects with a history of other medical condition(s) known to affect blood glucose values (i.e., cushing's disease, acromegaly).
    boolean
    C0012634 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0005802 (UMLS CUI [1,3])
    Chronic systemic inflammatory or autoimmune disease or other severe medical condition
    Item
    subjects with a history of other chronic systemic inflammatory or autoimmune disease or other severe medical condition. (a history of treated hypothyroidism with documentation of normal serum thyroid hormone levels will not be exclusionary.)
    boolean
    C1290884 (UMLS CUI [1])
    C0004364 (UMLS CUI [2])
    C0009488 (UMLS CUI [3])
    Hepatitis B, Hepatitis C, or HIV
    Item
    patients with a history of hepatitis b, hepatitis c, or hiv.
    boolean
    C0019163 (UMLS CUI [1])
    C0019196 (UMLS CUI [2])
    C0019693 (UMLS CUI [3])
    PPD positive
    Item
    ppd positive at the time of evaluation.
    boolean
    C0032739 (UMLS CUI [1])
    Thrombocytopenia or neutropenia
    Item
    thrombocytopenia or neutropenia. individuals will be considered to have thrombocytopenia if they have a platelet count <100,000 platelets/mm2 or <3,000 wbc/ml.
    boolean
    C0032181 (UMLS CUI [1])
    C0023508 (UMLS CUI [2])
    Renal, pulmonary, or cardiac failure
    Item
    subjects with a history of renal, pulmonary, or cardiac failure
    boolean
    C0035078 (UMLS CUI [1])
    C0948755 (UMLS CUI [2])
    C0018801 (UMLS CUI [3])
    Infection
    Item
    subjects with severe systemic infections. only those subjects who have completed treatment and have shown a complete clinical resolution will be considered eligible for the study.
    boolean
    C0009450 (UMLS CUI [1])

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