Informações:
Falhas:
ID
14610
Descrição
A Study of the Efficacy and Safety of Topiramate in the Treatment fo Obese, Type 2 Diabetic Patients Treated With Metformin; ODM derived from: https://clinicaltrials.gov/show/NCT00231660
Link
https://clinicaltrials.gov/show/NCT00231660
Palavras-chave
Versões (1)
- 24/04/2016 24/04/2016 -
Transferido a
24 de abril de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Obesity NCT00231660
Eligibility Obesity NCT00231660
- StudyEvent: Eligibility
Similar models
Eligibility Obesity NCT00231660
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Type 2 diabetes and metformin monotherapy
Item
diagnosis of type 2 diabetes and receiving metformin monotherapy for at least the previous 4 months and on a stable daily dose for at least 2 months prior to enrollment
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C0025598 (UMLS CUI [2])
Metformin total daily dose
Item
metformin total daily dose not to exceed 2.1 grams/day
boolean
C0025598 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,2])
BMI
Item
body mass index >= 27 and < 50
boolean
C1305855 (UMLS CUI [1])
HbA1C
Item
hba1c < 11%
boolean
C0019018 (UMLS CUI [1])
Fasting plasma glucose
Item
fasting plasma glucose >= 126 and < 240
boolean
C0583513 (UMLS CUI [1])
Stable weight
Item
stable weight
boolean
C0517386 (UMLS CUI [1])
Gynaecological status
Item
female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, or practicing an acceptable method of contraception (requires negative pregnancy test)
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0032976 (UMLS CUI [4])
C0015787 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0032976 (UMLS CUI [4])
Contraindication or hypersensitivity to topiramate
Item
known contraindication, or hypersensitivity to topiramate
boolean
C1301624 (UMLS CUI [1,1])
C0076829 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0076829 (UMLS CUI [2,2])
C0076829 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0076829 (UMLS CUI [2,2])
Antidiabetic medications
Item
use of other antidiabetic medications within the last 4 months
boolean
C0935929 (UMLS CUI [1])
Weight loss
Item
excessive weight loss
boolean
C1262477 (UMLS CUI [1])
Type 1 diabetes
Item
diagnosis of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Hypoglycemia
Item
history of severe or recurrent hypoglycemic episodes
boolean
C0020615 (UMLS CUI [1])
Pulmonary disease
Item
severe pulmonary disease
boolean
C0024115 (UMLS CUI [1])