Information:
Fel:
ID
18600
Beskrivning
A Study on Efficacy and Safety of Topiramate OROS Controlled-Release in Obese, Type 2 Diabetic Subjects Managed With Diet or Metformin; ODM derived from: https://clinicaltrials.gov/show/NCT00231647
Länk
https://clinicaltrials.gov/show/NCT00231647
Nyckelord
Versioner (1)
- 2016-11-11 2016-11-11 -
Uppladdad den
11 november 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Obesity NCT00231647
Eligibility Obesity NCT00231647
- StudyEvent: Eligibility
Similar models
Eligibility Obesity NCT00231647
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Body mass index
Item
body mass index (bmi) >= 27 kg/m^2 and <50 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Metformin
Item
diagnosis of type 2 diabetes, managed with either diet alone or combined with monotherapy treatment with metformin
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
C0012159 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
Stable body weight Duration
Item
stable weight for at least 2 months
boolean
C0517386 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
Postmenopausal state | Female Sterilization | Sexual Abstinence | Contraceptive methods | Pregnancy test negative
Item
female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test).
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0036899 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
C0427780 (UMLS CUI [5])
C0015787 (UMLS CUI [2])
C0036899 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
C0427780 (UMLS CUI [5])
Medical contraindication topiramate | Hypersensitivity topiramate
Item
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])
Investigational New Drugs Exposure to | Investigational Medical Device Exposure to
Item
exposure to any other experimental drug or device within past 90 days
boolean
C0013230 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C2346570 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0332157 (UMLS CUI [1,2])
C2346570 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
Diabetes Mellitus, Insulin-Dependent
Item
established diagnosis of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Hypoglycaemic episode Quantity Severe | Recurrent hypoglycemia
Item
history of severe or recurrent hypoglycemic episodes prior to study entry
boolean
C0745153 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C1846288 (UMLS CUI [2])
C1265611 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C1846288 (UMLS CUI [2])
Antidiabetics Oral | Metformin
Item
taking oral antidiabetic medications other than metformin
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2])
C1527415 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2])
Insulin
Item
treatment with insulin within 4 months
boolean
C0021641 (UMLS CUI [1])
Liver diseases Significant | Kidney Diseases Significant | Cardiovascular Diseases Significant
Item
significant liver, kidney or cardiovascular diseases.
boolean
C0023895 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0007222 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
C0750502 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0007222 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])