0 Evaluaciones
ID

34681

Descripción

Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01189422

Link

https://clinicaltrials.gov/show/NCT01189422

Palabras clave

Versiones (1)
  1. 23/1/19 23/1/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

23 de enero de 2019

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility Type 1 Diabetes Mellitus NCT01189422

    Inglés

    Eligibility Type 1 Diabetes Mellitus NCT01189422

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    randomization after 12 weeks but within 12 months from first doctor visit for symptoms or signs of diabetes
    Descripción

    Randomization | Sign or Symptom Diabetes Mellitus

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0034656
    UMLS CUI [2,1]
    C3540840
    UMLS CUI [2,2]
    C0011849
    diagnosis of type 1 diabetes mellitus
    Descripción

    Diabetes Mellitus, Insulin-Dependent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0011854
    currently receiving insulin therapy
    Descripción

    Insulin regime

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0557978
    detectable fasting or stimulated c-peptide level at screening
    Descripción

    Fasting C-peptide level Detectable | C-peptide level Stimulated Detectable

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2208720
    UMLS CUI [1,2]
    C3830527
    UMLS CUI [2,1]
    C0202100
    UMLS CUI [2,2]
    C1948023
    UMLS CUI [2,3]
    C3830527
    one positive autoantibody test result at screening: islet-cell autoantibodies (ica512)/islet antigen-2 (ia-2),glutamic acid decarboxylase (gad) autoantibodies, or insulin autoantibodies
    Descripción

    Autoantibody test Result Positive | ICA512 autoantibody | IA-2 autoantibody | Glutamic Acid Decarboxylase Autoantibodies | Insulin autoantibody

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1272321
    UMLS CUI [1,2]
    C1274040
    UMLS CUI [1,3]
    C1514241
    UMLS CUI [2]
    C0382981
    UMLS CUI [3]
    C0663193
    UMLS CUI [4,1]
    C0017785
    UMLS CUI [4,2]
    C0004358
    UMLS CUI [5]
    C1275890
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
    Descripción

    Medical condition Interferes with Completion of clinical trial

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C0521102
    UMLS CUI [1,3]
    C2732579
    previous treatment with monoclonal antibody
    Descripción

    Monoclonal Antibody Therapy Previous

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0279694
    UMLS CUI [1,2]
    C0205156
    current treatment with oral antidiabetic agents
    Descripción

    Antidiabetics Oral

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0935929
    UMLS CUI [1,2]
    C1527415
    evidence of active infection
    Descripción

    Communicable Disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    Volver a la parte superior de la página

    Similar models

    Eligibility Type 1 Diabetes Mellitus NCT01189422

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Randomization | Sign or Symptom Diabetes Mellitus
    Item
    randomization after 12 weeks but within 12 months from first doctor visit for symptoms or signs of diabetes
    boolean
    C0034656 (UMLS CUI [1])
    C3540840 (UMLS CUI [2,1])
    C0011849 (UMLS CUI [2,2])
    Diabetes Mellitus, Insulin-Dependent
    Item
    diagnosis of type 1 diabetes mellitus
    boolean
    C0011854 (UMLS CUI [1])
    Insulin regime
    Item
    currently receiving insulin therapy
    boolean
    C0557978 (UMLS CUI [1])
    Fasting C-peptide level Detectable | C-peptide level Stimulated Detectable
    Item
    detectable fasting or stimulated c-peptide level at screening
    boolean
    C2208720 (UMLS CUI [1,1])
    C3830527 (UMLS CUI [1,2])
    C0202100 (UMLS CUI [2,1])
    C1948023 (UMLS CUI [2,2])
    C3830527 (UMLS CUI [2,3])
    Autoantibody test Result Positive | ICA512 autoantibody | IA-2 autoantibody | Glutamic Acid Decarboxylase Autoantibodies | Insulin autoantibody
    Item
    one positive autoantibody test result at screening: islet-cell autoantibodies (ica512)/islet antigen-2 (ia-2),glutamic acid decarboxylase (gad) autoantibodies, or insulin autoantibodies
    boolean
    C1272321 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    C1514241 (UMLS CUI [1,3])
    C0382981 (UMLS CUI [2])
    C0663193 (UMLS CUI [3])
    C0017785 (UMLS CUI [4,1])
    C0004358 (UMLS CUI [4,2])
    C1275890 (UMLS CUI [5])
    Item Group
    C0680251 (UMLS CUI)
    Medical condition Interferes with Completion of clinical trial
    Item
    any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
    boolean
    C3843040 (UMLS CUI [1,1])
    C0521102 (UMLS CUI [1,2])
    C2732579 (UMLS CUI [1,3])
    Monoclonal Antibody Therapy Previous
    Item
    previous treatment with monoclonal antibody
    boolean
    C0279694 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    Antidiabetics Oral
    Item
    current treatment with oral antidiabetic agents
    boolean
    C0935929 (UMLS CUI [1,1])
    C1527415 (UMLS CUI [1,2])
    Communicable Disease
    Item
    evidence of active infection
    boolean
    C0009450 (UMLS CUI [1])
    Volver a la parte superior de la página 

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