Information:
Fel:
ID
15254
Beskrivning
A Study of the Safety and Efficacy of Topiramate in the Treatment of Obese, Type 2 Diabetes Patients on a Controlled Diet; ODM derived from: https://clinicaltrials.gov/show/NCT00231530
Länk
https://clinicaltrials.gov/show/NCT00231530
Nyckelord
Versioner (1)
- 2016-05-23 2016-05-23 -
Uppladdad den
23 maj 2016
DOI
För en begäran logga in.
Licens
Creative Commons BY 4.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Eligibility Obesity NCT00231530
Eligibility Obesity NCT00231530
- StudyEvent: Eligibility
Similar models
Eligibility Obesity NCT00231530
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
BMI
Item
body mass index >= 27 and < 50
boolean
C1305855 (UMLS CUI [1])
type 2 diabetes
Item
diagnosis of type 2 diabetes according to either swedish guideline or the american diabetes association (ada) criteria
boolean
C0011860 (UMLS CUI [1])
hba1c
Item
hba1c < 10.5% at enrollment
boolean
C0019018 (UMLS CUI [1])
no previous oral antidiabetic medication or insulin therapy
Item
no previous oral antidiabetic medication or insulin therapy
boolean
C0935929 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
C0021641 (UMLS CUI [2])
stable body weight
Item
stable body weight
boolean
C0517386 (UMLS CUI [1])
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])
C1999124 (UMLS CUI [2])
C1999124 (UMLS CUI [2])
hypersensitivity to topiramate
Item
known contraindication or hypersensitivity to topiramate
boolean
C1301624 (UMLS CUI [1,1])
C0076829 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
C0076829 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
fasting plasma glucose
Item
fasting plasma glucose (fpg) >= 13.1 millimolesl/liter (240 milligrams/deciliter) at baseline, visit 4 (week 0)
boolean
C0583513 (UMLS CUI [1])
Hba1c
Item
hba1c of >10.5% at enrollment
boolean
C0019018 (UMLS CUI [1])
severe recurrent hypoglycemic episodes
Item
history of severe recurrent hypoglycemic episodes prior to study entry
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])
systemic corticosteroids
Item
use of any systemic corticosteroids within 30 days of enrollment
boolean
C2825233 (UMLS CUI [1])
type 1 diabetes
Item
diagnosed type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
cardiovascular disease
Item
history of significant cardiovascular disease, uncontrolled thyroid disease, or kidney stones
boolean
C0007222 (UMLS CUI [1])
C0040128 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0022650 (UMLS CUI [3])
C0040128 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0022650 (UMLS CUI [3])