Informações:
Falhas:
ID
22953
Descrição
Study of Safety and Effectiveness of Apidra® in Combination With Basal Insulin in Patients With Type 1 & 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00526513
Link
https://clinicaltrials.gov/show/NCT00526513
Palavras-chave
Versões (1)
- 18/06/2017 18/06/2017 -
Transferido a
18 de junho de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Diabetes Mellitus NCT00526513
Eligibility Diabetes Mellitus NCT00526513
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes Mellitus NCT00526513
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
ID.1
Item
patients with type 1 or type 2 diabetes mellitus previously treated for 6 months with prandial insulin + basal insulin or premix (type i) or by either a basal insulin +
boolean
C0011849 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
ID.2
Item
oad or basal + rhi/other short acting analogue insulin or premix (type ii) with hba1c >7%.
boolean
C0356365 (UMLS CUI [1,1])
C0019018 (UMLS CUI [1,2])
C0019018 (UMLS CUI [1,2])
ID.3
Item
adequate hepatic and renal functions
boolean
C0232805 (UMLS CUI [1,1])
C0232741 (UMLS CUI [1,2])
C0232741 (UMLS CUI [1,2])
ID.4
Item
ability and willingness of a tight antidiabetic therapy and to perform blood glucose self-monitoring and especially blood glucose profiles, using a blood glucometer at home.
boolean
C0005803 (UMLS CUI [1,1])
C0935929 (UMLS CUI [1,2])
C0935929 (UMLS CUI [1,2])
ID.5
Item
pregnant or lactating women or women of childbearing potential not using adequate contraception.
boolean
C0032961 (UMLS CUI [1,1])
C0009862 (UMLS CUI [1,2])
C0009862 (UMLS CUI [1,2])
ID.6
Item
patients with hypersensitivity to insulin glulisine or to any of the excipients.
boolean
C0020517 (UMLS CUI [1,1])
C1313386 (UMLS CUI [1,2])
C1313386 (UMLS CUI [1,2])
ID.7
Item
history of diabetic ketoacidosis.
boolean
C0220982 (UMLS CUI [1])
ID.8
Item
diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the 3 months prior to study entry or which may require surgical treatment within 3 months of study entry.
boolean
C0011884 (UMLS CUI [1])
ID.9
Item
alcohol abuse or drug abuse.
boolean
C0013146 (UMLS CUI [1,1])
C0085762 (UMLS CUI [1,2])
C0085762 (UMLS CUI [1,2])
ID.10
Item
clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, hematological or psychiatric illness, other serious illnesses, uncontrolled medical conditions or active infections making implementation of the protocol difficult.
boolean
C0012634 (UMLS CUI [1])
ID.11
Item
medical, psychiatric, or neurologic condition that renders the patient unable to understand the nature and scope of the study. mental retardation or language barrier such that the patient is unable to give informed consent.
boolean
C0021430 (UMLS CUI [1])
ID.12
Item
participation in an investigational trial within 30 days of study entry.
boolean
C0008976 (UMLS CUI [1])
ID.13
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean