0 Evaluaciones

ID

43524

Descripción

Comparison of Single Dose and Steady State Pharmacodynamics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01526941

Link

https://clinicaltrials.gov/show/NCT01526941

Palabras clave

  1. 29/5/16 29/5/16 -
  2. 20/9/21 20/9/21 -
Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0

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    Eligibility Diabetes NCT01526941

    Eligibility Diabetes NCT01526941

    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT01526941
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    type 1 diabetes for at least 12 months
    Descripción

    type 1 diabetes

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0011854
    currently on basal bolus treatment with soluble human insulin, lispro and nph insulin or lantus. nph insulin may be administered once or twice daily
    Descripción

    soluble human insulin, lispro, nph insulin, lantus

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0795635
    UMLS CUI [2]
    C0293359
    UMLS CUI [3]
    C0021658
    UMLS CUI [4]
    C0907402
    bmi (body mass index) maximum 35 kg/m^2
    Descripción

    bmi

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    able and willing to perform self-blood glucose monitoring
    Descripción

    self blood glucose monitoring

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0005803
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    the receipt of any investigational drug within the last 30 days prior to this trial
    Descripción

    investigational drug

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    total daily insulin dose at least 1.8 u/kg/day
    Descripción

    total daily insulin dose

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2348070
    UMLS CUI [1,2]
    C0557978
    currently being treated with insulin aspart products
    Descripción

    insulin aspart

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1708521
    a history of drug abuse or alcohol dependence within the last 5 years
    Descripción

    substance abuse

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    impaired hepatic function
    Descripción

    impaired hepatic function

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    impaired renal function
    Descripción

    renal function

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0232804
    blood donation (exceeding 500 ml) within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory
    Descripción

    blood donation, hemoglobin

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0005794
    UMLS CUI [2]
    C0019046
    cardiac problems
    Descripción

    cardiac problems

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0262402
    severe, uncontrolled hypertension
    Descripción

    hypertension

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0020538

    Similar models

    Eligibility Diabetes NCT01526941

    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT01526941
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    type 1 diabetes
    Item
    type 1 diabetes for at least 12 months
    boolean
    C0011854 (UMLS CUI [1])
    soluble human insulin, lispro, nph insulin, lantus
    Item
    currently on basal bolus treatment with soluble human insulin, lispro and nph insulin or lantus. nph insulin may be administered once or twice daily
    boolean
    C0795635 (UMLS CUI [1])
    C0293359 (UMLS CUI [2])
    C0021658 (UMLS CUI [3])
    C0907402 (UMLS CUI [4])
    bmi
    Item
    bmi (body mass index) maximum 35 kg/m^2
    boolean
    C1305855 (UMLS CUI [1])
    self blood glucose monitoring
    Item
    able and willing to perform self-blood glucose monitoring
    boolean
    C0005803 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    investigational drug
    Item
    the receipt of any investigational drug within the last 30 days prior to this trial
    boolean
    C0013230 (UMLS CUI [1])
    total daily insulin dose
    Item
    total daily insulin dose at least 1.8 u/kg/day
    boolean
    C2348070 (UMLS CUI [1,1])
    C0557978 (UMLS CUI [1,2])
    insulin aspart
    Item
    currently being treated with insulin aspart products
    boolean
    C1708521 (UMLS CUI [1])
    substance abuse
    Item
    a history of drug abuse or alcohol dependence within the last 5 years
    boolean
    C0038586 (UMLS CUI [1])
    impaired hepatic function
    Item
    impaired hepatic function
    boolean
    C0232741 (UMLS CUI [1])
    renal function
    Item
    impaired renal function
    boolean
    C0232804 (UMLS CUI [1])
    blood donation, hemoglobin
    Item
    blood donation (exceeding 500 ml) within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory
    boolean
    C0005794 (UMLS CUI [1])
    C0019046 (UMLS CUI [2])
    cardiac problems
    Item
    cardiac problems
    boolean
    C0262402 (UMLS CUI [1])
    hypertension
    Item
    severe, uncontrolled hypertension
    boolean
    C0020538 (UMLS CUI [1])

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