Informações:
Falhas:
ID
44005
Descrição
Safety of Insulin Detemir in Children With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00605137
Link
https://clinicaltrials.gov/show/NCT00605137
Palavras-chave
Versões (2)
- 06/09/2016 06/09/2016 -
- 20/09/2021 20/09/2021 -
Transferido a
20 de setembro de 2021
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Diabetes NCT00605137
Eligibility Diabetes NCT00605137
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes NCT00605137
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Insulin-Dependent Diabetes Mellitus disease length
Item
type 1 diabetes for at least one year
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,2])
Basal insulin | bolus infusion | Intermediate-acting insulin | Insulin, Long-Acting | Insulin Aspart | Insulin soluble human
Item
current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart and/or soluble human insulin
boolean
C0650607 (UMLS CUI [1])
C1511237 (UMLS CUI [2])
C0304869 (UMLS CUI [3])
C0304870 (UMLS CUI [4])
C1708521 (UMLS CUI [5])
C0795635 (UMLS CUI [6])
C1511237 (UMLS CUI [2])
C0304869 (UMLS CUI [3])
C0304870 (UMLS CUI [4])
C1708521 (UMLS CUI [5])
C0795635 (UMLS CUI [6])
Glycosylated hemoglobin A
Item
hba1c below 11.0%
boolean
C0019018 (UMLS CUI [1])
Compliance behavior
Item
willing to comply with investigator's instructions
boolean
C1321605 (UMLS CUI [1])
Capillary blood glucose measurement Self Monitoring Willing | Therapeutic procedure Hypoglycemia
Item
able and willing to perform self-monitoring of capillary blood glucose and to take measures in case of hypoglycaemia
boolean
C0457578 (UMLS CUI [1,1])
C0588436 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0020615 (UMLS CUI [2,2])
C0588436 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0020615 (UMLS CUI [2,2])
Renal Insufficiency
Item
impaired renal function
boolean
C1565489 (UMLS CUI [1])
Hepatic Insufficiency
Item
impaired hepatic function
boolean
C1306571 (UMLS CUI [1])
Loss of hypoglycemic warning | Recurrent severe hypoglycemia
Item
known hypoglycaemia unawareness or recurrent major hypoglycaemia (as judged by the investigator or sub-investigator)
boolean
C0342317 (UMLS CUI [1])
C0342316 (UMLS CUI [2])
C0342316 (UMLS CUI [2])
Proliferative retinopathy Requirement Therapeutic procedure | Disorder of macula of retina Proliferative Requirement Therapeutic procedure
Item
proliferative retinopathy or maculopathy requiring acute treatment
boolean
C0339467 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0730362 (UMLS CUI [2,1])
C0334094 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0730362 (UMLS CUI [2,1])
C0334094 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
Uncontrolled hypertension Treated | Uncontrolled hypertension untreated
Item
uncontrolled treated/untreated hypertension
boolean
C1868885 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C1522326 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Insulin regime Dose Total U/kg/day
Item
current treatment with total daily insulin dose of more than 2.00 iu/kg
boolean
C0557978 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C1532634 (UMLS CUI [1,4])
C0178602 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C1532634 (UMLS CUI [1,4])
systemic steroids
Item
current treatment or expected at the screening to start treatment with systemic corticosteroids
boolean
C2825233 (UMLS CUI [1])
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