Information:
Fel:
ID
15255
Beskrivning
A Study of the Efficacy and Safety of Topiramate in Obese, Type 2 Diabetic Patients Inadequately Controlled on Sulfonylurea Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00231634
Länk
https://clinicaltrials.gov/show/NCT00231634
Nyckelord
Versioner (1)
- 2016-05-23 2016-05-23 -
Uppladdad den
23 maj 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Obesity NCT00231634
Eligibility Obesity NCT00231634
- StudyEvent: Eligibility
Similar models
Eligibility Obesity NCT00231634
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
type 2 diabetes
Item
diagnosis of type 2 diabetes, receiving only second generation sulfonylurea therapy (may include: glipizide, gliclazide, glimepiride, glibenclamide/glyburide, and gliquadone) for at least 4 months and on stable dose for at least 2 months
boolean
C0011860 (UMLS CUI [1])
BMI
Item
body mass index >= 27 and < 50
boolean
C1305855 (UMLS CUI [1])
Hba1c
Item
hba1c < 11% at enrollment
boolean
C0019018 (UMLS CUI [1])
hypertension or hyperlipidemia
Item
diagnosed hypertension or hyperlipidemia must be controlled
boolean
C0745117 (UMLS CUI [1])
C0020473 (UMLS CUI [2,1])
C0742801 (UMLS CUI [2,2])
C0020473 (UMLS CUI [2,1])
C0742801 (UMLS CUI [2,2])
postmenopausal or contraceptive use
Item
female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing an acceptable method of contraception (requires negative pregnancy test)
boolean
C0232970 (UMLS CUI [1,1])
C1999124 (UMLS CUI [1,2])
C1999124 (UMLS CUI [1,2])
hypersensitivity to topiramate
Item
known contraindication or hypersensitivity to topiramate or sulfonylurea therapy
boolean
C1301624 (UMLS CUI [1,1])
C0076829 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
C0038766 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
C0020517 (UMLS CUI [2,3])
C0076829 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
C0038766 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
C0020517 (UMLS CUI [2,3])
pregnancy or nursing
Item
pregnancy or women who are nursing or plan to become pregnant during the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
type 1 diabetes
Item
diagnosed with type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
severe recurrent hypoglycemic episodes
Item
history of severe or recurrent hypoglycemic episodes
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2945760 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,2])
C2945760 (UMLS CUI [1,3])
antidiabetic agent
Item
treatment with any antidiabetic agent other than sulfonylurea
boolean
C0935929 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])