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ID

16525

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00024518

Stichworte

  1. 22.07.16 22.07.16 -
Hochgeladen am

22. Juli 2016

DOI

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Creative Commons BY 4.0

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    Eligibility Insulin-Dependent Diabetes Mellitus NCT00024518

    Eligibility Insulin-Dependent Diabetes Mellitus NCT00024518

    Criteria
    Beschreibung

    Criteria

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

    t1dm of less than 6 weeks duration

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0011854 (Diabetes Mellitus, Insulin-Dependent)
    SNOMED
    46635009
    UMLS CUI [1,2]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    besides t1dm, no concurrent illness.
    Beschreibung

    besides t1dm, no concurrent illness.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0009488 (Comorbidity)
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    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.
    Beschreibung

    treatment with immunosuppressive or immunostimulatory medications

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021079 (Therapeutic immunosuppression)
    SNOMED
    86553008
    abnormal pre-treatment white blood cell count (wbc) or thrombocytopenia.
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023508 (White Blood Cell Count procedure)
    SNOMED
    767002
    UMLS CUI [2]
    C0040034 (Thrombocytopenia)
    SNOMED
    302215000
    known active diseases, e.g. cardiac, renal, hepatic diseases or immunodeficiency.
    Beschreibung

    known active diseases

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2707252 (Active disease diagnosis)
    LOINC
    LP89688-3
    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.
    Beschreibung

    comorbidities

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [2]
    C0027765 (nervous system disorder)
    SNOMED
    118940003
    LOINC
    LA10590-0
    UMLS CUI [3]
    C0085096 (Peripheral Vascular Diseases)
    SNOMED
    400047006
    UMLS CUI [4]
    C0004364 (Autoimmune Diseases)
    SNOMED
    85828009
    UMLS CUI [5]
    C0007820 (Cerebrovascular Disorders)
    SNOMED
    62914000
    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.
    Beschreibung

    ongoing use of medications except insulin

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0205420 (Concurrent)
    SNOMED
    68405009
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
    Beschreibung

    medical condition compromising trial protocol

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [1,3]
    C0009488 (Comorbidity)
    inability to give informed consent or assent.
    Beschreibung

    inability to give informed consent or assent.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430 (Informed Consent)
    UMLS CUI [1,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [1,3]
    C0009488 (Comorbidity)
    participation in a clinical trial within the previous 6 weeks.
    Beschreibung

    clinical trial participation status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    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).
    Beschreibung

    pregnant or lactating

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [1,2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    age above 25 years, since there may be several subtypes of t1dm.
    Beschreibung

    age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6

    Ähnliche Modelle

    Eligibility Insulin-Dependent Diabetes Mellitus NCT00024518

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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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