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ID

16525

Beskrivning

Interferon-Alpha for Diabetes Mellitus Type 1; ODM derived from: https://clinicaltrials.gov/show/NCT00024518

Länk

https://clinicaltrials.gov/show/NCT00024518

Nyckelord

  1. 2016-07-22 2016-07-22 -
Uppladdad den

22 juli 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Insulin-Dependent Diabetes Mellitus NCT00024518

    Eligibility Insulin-Dependent Diabetes Mellitus NCT00024518

    Criteria
    Beskrivning

    Criteria

    t1dm of less than 6 weeks duration in patients between 3 and 25 years of age.
    Beskrivning

    t1dm of less than 6 weeks duration

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0011854
    UMLS CUI [1,2]
    C0001779
    besides t1dm, no concurrent illness.
    Beskrivning

    besides t1dm, no concurrent illness.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    treatment with immunosuppressive or immunostimulatory medications such as azathioprine, nicotinamide, superoxide dismutase-desferroxamine, aminoguanidine, oral insulin or other experimental therapies at the present time or in the past.
    Beskrivning

    treatment with immunosuppressive or immunostimulatory medications

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021079
    abnormal pre-treatment white blood cell count (wbc) or thrombocytopenia.
    Beskrivning

    abnormal pre-treatment white blood cell count (wbc) or thrombocytopenia.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023508
    UMLS CUI [2]
    C0040034
    known active diseases, e.g. cardiac, renal, hepatic diseases or immunodeficiency.
    Beskrivning

    known active diseases

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2707252
    history of cancer, neuropathy seizure disorders (except typical history of febrile seizures in childhood), peripheral vascular disease, coagulation abnormalities, autoimmune disease (except type 1 diabetes) or cerebrovascular disease.
    Beskrivning

    comorbidities

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2]
    C0027765
    UMLS CUI [3]
    C0085096
    UMLS CUI [4]
    C0004364
    UMLS CUI [5]
    C0007820
    ongoing use of medications known to influence glucose tolerance (e.g. sulfonylureas, metformin, diphenylhydantoin, thiazide or other potassium depleting diuretics, beta-adrenergic blockers, niacin) except insulin.
    Beskrivning

    ongoing use of medications except insulin

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0205420
    UMLS CUI [1,2]
    C0013227
    any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
    Beskrivning

    medical condition compromising trial protocol

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    inability to give informed consent or assent.
    Beskrivning

    inability to give informed consent or assent.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    participation in a clinical trial within the previous 6 weeks.
    Beskrivning

    clinical trial participation status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    lactating or pregnant female individual (individuals will be advised not to volunteer for the protocol if they plan to become pregnant during the time of the study and they are instructed to use an effective method of contraception).
    Beskrivning

    pregnant or lactating

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0006147
    age above 25 years, since there may be several subtypes of t1dm.
    Beskrivning

    age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779

    Similar models

    Eligibility Insulin-Dependent Diabetes Mellitus NCT00024518

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    t1dm of less than 6 weeks duration
    Item
    t1dm of less than 6 weeks duration in patients between 3 and 25 years of age.
    boolean
    C0011854 (UMLS CUI [1,1])
    C0001779 (UMLS CUI [1,2])
    besides t1dm, no concurrent illness.
    Item
    besides t1dm, no concurrent illness.
    boolean
    C0009488 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    treatment with immunosuppressive or immunostimulatory medications
    Item
    treatment with immunosuppressive or immunostimulatory medications such as azathioprine, nicotinamide, superoxide dismutase-desferroxamine, aminoguanidine, oral insulin or other experimental therapies at the present time or in the past.
    boolean
    C0021079 (UMLS CUI [1])
    abnormal pre-treatment white blood cell count (wbc) or thrombocytopenia.
    Item
    abnormal pre-treatment white blood cell count (wbc) or thrombocytopenia.
    boolean
    C0023508 (UMLS CUI [1])
    C0040034 (UMLS CUI [2])
    known active diseases
    Item
    known active diseases, e.g. cardiac, renal, hepatic diseases or immunodeficiency.
    boolean
    C2707252 (UMLS CUI [1])
    comorbidities
    Item
    history of cancer, neuropathy seizure disorders (except typical history of febrile seizures in childhood), peripheral vascular disease, coagulation abnormalities, autoimmune disease (except type 1 diabetes) or cerebrovascular disease.
    boolean
    C0006826 (UMLS CUI [1])
    C0027765 (UMLS CUI [2])
    C0085096 (UMLS CUI [3])
    C0004364 (UMLS CUI [4])
    C0007820 (UMLS CUI [5])
    ongoing use of medications except insulin
    Item
    ongoing use of medications known to influence glucose tolerance (e.g. sulfonylureas, metformin, diphenylhydantoin, thiazide or other potassium depleting diuretics, beta-adrenergic blockers, niacin) except insulin.
    boolean
    C0205420 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    medical condition compromising trial protocol
    Item
    any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    inability to give informed consent or assent.
    Item
    inability to give informed consent or assent.
    boolean
    C0021430 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    clinical trial participation status
    Item
    participation in a clinical trial within the previous 6 weeks.
    boolean
    C2348568 (UMLS CUI [1])
    pregnant or lactating
    Item
    lactating or pregnant female individual (individuals will be advised not to volunteer for the protocol if they plan to become pregnant during the time of the study and they are instructed to use an effective method of contraception).
    boolean
    C0032961 (UMLS CUI [1,1])
    C0006147 (UMLS CUI [1,2])
    age
    Item
    age above 25 years, since there may be several subtypes of t1dm.
    boolean
    C0001779 (UMLS CUI [1])

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