Informações:
Falhas:
ID
21097
Descrição
Evaluation of Glucose Lowering Effect, Safety and Tolerability of CS-917; ODM derived from: https://clinicaltrials.gov/show/NCT00290940
Link
https://clinicaltrials.gov/show/NCT00290940
Palavras-chave
Versões (1)
- 10/04/2017 10/04/2017 -
Transferido a
10 de abril de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00290940
Eligibility Diabetes Mellitus, Type 2 NCT00290940
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes Mellitus, Type 2 NCT00290940
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Diabetes mellitus type 2: newly diagnosed
Item
drug naive or newly diagnosed type 2 diabetic subjects:
boolean
C0011860 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C1518321 (UMLS CUI [1,2])
Never received diabetes mellitus therapy
Item
never received oral antihyperglycemic or insulin therapy or
boolean
C0948092 (UMLS CUI [1,1])
C2003901 (UMLS CUI [1,2])
C2003901 (UMLS CUI [1,2])
Diabetes mellitus therapy: last half year
Item
no oral antihyperglycemic or insulin therapy for more than 6 months since original diagnosis and
boolean
C0948092 (UMLS CUI [1,1])
C4082120 (UMLS CUI [1,2])
C4082120 (UMLS CUI [1,2])
Insulin therapy
Item
no insulin therapy within one year of screening, with the exception of use during hospitalization or for use in gestational diabetes and
boolean
C0557978 (UMLS CUI [1])
Antihyperglycemic therapy
Item
no antihyperglycemic therapy for more than three consecutive days, or a total of of seven non-consecutive days, during the 8 weeks prior to screening.
boolean
C0020616 (UMLS CUI [1])
HbA1c
Item
hba1c>6.7% and < or = to 10% at screening
boolean
C0019018 (UMLS CUI [1])
Current insulin therapy
Item
current insulin therapy
boolean
C0557978 (UMLS CUI [1])
Diabetes mellitus poor control
Item
poorly controlled diabetes
boolean
C0860161 (UMLS CUI [1])
Diabetic ketoacidosis or hyperosmolar, nonketonic coma
Item
history of diabetic ketoacidosis or hyperosmolar, nonketonic coma within one year of screening
boolean
C0011880 (UMLS CUI [1])
C0020457 (UMLS CUI [2])
C0020457 (UMLS CUI [2])
Serum bicarbonate measurement
Item
serum bicarbonate < or = to 19 meq/l
boolean
C0428301 (UMLS CUI [1])
Serum creatinine measurement
Item
serum creatinine (scr) > 1.4 mg/dl (females) or 1.5 mg/dl (males)
boolean
C0201976 (UMLS CUI [1])
Contraindication to metformin
Item
contraindication to metformin
boolean
C0025598 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,2])