ID

14104

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00832182

Stichworte

  1. 29.03.16 29.03.16 -
Hochgeladen am

29. März 2016

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Diabetes NCT00832182

Eligibility Diabetes NCT00832182

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00832182
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
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)
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
the subject must have completed the ana/dcd/065 trial
Beschreibung

Participation status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
impaired hepatic function
Beschreibung

Hepatic function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
impaired renal function
Beschreibung

Renal function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
total daily insulin requirements of more than 1.4 u/kg
Beschreibung

Insulin regime

Datentyp

boolean

Alias
UMLS CUI [1]
C0557978
cardiac problems
Beschreibung

Cardiac problems

Datentyp

boolean

Alias
UMLS CUI [1]
C0262402
uncontrolled hypertension
Beschreibung

Uncontrolled hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
known or suspected allergy to trial product or related products
Beschreibung

Allergy to trial product

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3854006
current hypoglycaemic unawareness as judged by the investigator
Beschreibung

Hypoglycaemic unawareness

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0150114
known or suspect abuse of alcohol or narcotics
Beschreibung

Substance use disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
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)
Beschreibung

Gynaecological status

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
any condition that the investigator and/or sponsor feels would interfere with trial participation or evaluation of results
Beschreibung

Participation limited by comorbidity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488

Ähnliche Modelle

Eligibility Diabetes NCT00832182

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00832182
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
Hypoglycaemic unawareness
Item
current hypoglycaemic unawareness as judged by the investigator
boolean
C0020615 (UMLS CUI [1,1])
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])
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])

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