Information:
Fel:
ID
14104
Beskrivning
Examining the Long-term Safety of Insulin Aspart When Used as a Part of the Treatment for Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00832182
Länk
https://clinicaltrials.gov/show/NCT00832182
Nyckelord
Versioner (1)
- 2016-03-29 2016-03-29 -
Uppladdad den
29 mars 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Diabetes NCT00832182
Eligibility Diabetes NCT00832182
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes NCT00832182
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Informed consent
Item
signed informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject)
boolean
C0021430 (UMLS CUI [1])
Participation status
Item
the subject must have completed the ana/dcd/065 trial
boolean
C2348568 (UMLS CUI [1])
Hepatic function
Item
impaired hepatic function
boolean
C0232741 (UMLS CUI [1])
Renal function
Item
impaired renal function
boolean
C0232804 (UMLS CUI [1])
Insulin regime
Item
total daily insulin requirements of more than 1.4 u/kg
boolean
C0557978 (UMLS CUI [1])
Cardiac problems
Item
cardiac problems
boolean
C0262402 (UMLS CUI [1])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Allergy to trial product
Item
known or suspected allergy to trial product or related products
boolean
C0020517 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,2])
Hypoglycaemic unawareness
Item
current hypoglycaemic unawareness as judged by the investigator
boolean
C0020615 (UMLS CUI [1,1])
C0150114 (UMLS CUI [1,2])
C0150114 (UMLS CUI [1,2])
Substance use disorder
Item
known or suspect abuse of alcohol or narcotics
boolean
C0038586 (UMLS CUI [1])
Gynaecological status
Item
women breastfeeding or having the intention of becoming pregnant, or if judged not to be using adequate contraceptive measures (adequate measures are intrauterine device (iud), oral contraception and barrier methods)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Participation limited by comorbidity
Item
any condition that the investigator and/or sponsor feels would interfere with trial participation or evaluation of results
boolean
C2348568 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])