Informações:
Falhas:
ID
17300
Descrição
Efficacy and Safety of Insulin Detemir in Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00595374
Link
https://clinicaltrials.gov/show/NCT00595374
Palavras-chave
Versões (1)
- 05/09/2016 05/09/2016 -
Transferido a
5 de setembro de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Diabetes NCT00595374
Eligibility Diabetes NCT00595374
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes NCT00595374
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
C0700589 (UMLS CUI [1,2])
C4048193 (UMLS CUI [2])
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])
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])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])