0 Ratings
ID

17300

Description

Efficacy and Safety of Insulin Detemir in Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00595374

Link

https://clinicaltrials.gov/show/NCT00595374

Keywords

Versions (1)
  1. 9/5/16 9/5/16 -
Uploaded on

September 5, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    Eligibility Diabetes NCT00595374

    English

    Eligibility Diabetes NCT00595374

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT00595374
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    duration of type 1 diabetes for at least 12 months
    Description

    Insulin-Dependent Diabetes Mellitus disease length

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0011854
    UMLS CUI [1,2]
    C0872146
    bmi below 35 kg/m2
    Description

    Body mass index

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    hba1c between 7.0-12.0%
    Description

    Glycosylated hemoglobin A

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019018
    current treatment with preprandial short acting insulin and insulin nph once or twice daily for at least 6 months
    Description

    Short-Acting Insulin ante cibus U/day | insulin isophane U/day

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0356365
    UMLS CUI [1,2]
    C1550738
    UMLS CUI [1,3]
    C0456683
    UMLS CUI [2,1]
    C0021658
    UMLS CUI [2,2]
    C0456683
    fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the investigator
    Description

    Childbearing Potential Contraceptive methods | Risk of Pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0700589
    UMLS CUI [2]
    C4048193
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    known or suspected allergy to trial product or related products
    Description

    Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related Investigational New Drugs

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0013227
    UMLS CUI [2,3]
    C0439849
    UMLS CUI [2,4]
    C0013230
    previous participation in this trial
    Description

    Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    receipt of any investigational products within the last 2 months prior to this trial
    Description

    Investigational New Drugs

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    drug or alcohol dependence
    Description

    Substance Dependence

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038580
    pregnancy, breast-feeding or intention of becoming pregnant
    Description

    Pregnancy | Breast Feeding | Pregnancy, Planned

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3]
    C0032992
    Back to the top of the page

    Similar models

    Eligibility Diabetes NCT00595374

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT00595374
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Insulin-Dependent Diabetes Mellitus disease length
    Item
    duration of type 1 diabetes for at least 12 months
    boolean
    C0011854 (UMLS CUI [1,1])
    C0872146 (UMLS CUI [1,2])
    Body mass index
    Item
    bmi below 35 kg/m2
    boolean
    C1305855 (UMLS CUI [1])
    Glycosylated hemoglobin A
    Item
    hba1c between 7.0-12.0%
    boolean
    C0019018 (UMLS CUI [1])
    Short-Acting Insulin ante cibus U/day | insulin isophane U/day
    Item
    current treatment with preprandial short acting insulin and insulin nph once or twice daily for at least 6 months
    boolean
    C0356365 (UMLS CUI [1,1])
    C1550738 (UMLS CUI [1,2])
    C0456683 (UMLS CUI [1,3])
    C0021658 (UMLS CUI [2,1])
    C0456683 (UMLS CUI [2,2])
    Childbearing Potential Contraceptive methods | Risk of Pregnancy
    Item
    fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the investigator
    boolean
    C3831118 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C4048193 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related Investigational New Drugs
    Item
    known or suspected allergy to trial product or related products
    boolean
    C0020517 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0013227 (UMLS CUI [2,2])
    C0439849 (UMLS CUI [2,3])
    C0013230 (UMLS CUI [2,4])
    Study Subject Participation Status
    Item
    previous participation in this trial
    boolean
    C2348568 (UMLS CUI [1])
    Investigational New Drugs
    Item
    receipt of any investigational products within the last 2 months prior to this trial
    boolean
    C0013230 (UMLS CUI [1])
    Substance Dependence
    Item
    drug or alcohol dependence
    boolean
    C0038580 (UMLS CUI [1])
    Pregnancy | Breast Feeding | Pregnancy, Planned
    Item
    pregnancy, breast-feeding or intention of becoming pregnant
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0032992 (UMLS CUI [3])
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial