Information:
Fel:
ID
25545
Beskrivning
Randomized, Double-Blind Active Comparator-Controlled Study of Rivoglitazone in Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00484198
Länk
https://clinicaltrials.gov/show/NCT00484198
Nyckelord
Versioner (1)
- 2017-09-05 2017-09-05 -
Uppladdad den
5 september 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00484198
Eligibility Type 2 Diabetes Mellitus NCT00484198
- StudyEvent: Eligibility
Similar models
Eligibility Type 2 Diabetes Mellitus NCT00484198
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosis of type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Age
Item
male or female at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
a1c > 7% and less or equal to 8.5%
boolean
C0019018 (UMLS CUI [1])
C-peptide measurement
Item
non-fasting c-peptide > 0.5ng/ml
boolean
C0202100 (UMLS CUI [1])
Hypoglycemic Agents Dose Stable | Exception Thiazolidinediones
Item
current monotherapy treatment with stable dose of approved non-tzd antihyperglycemic medication for greater or equal to 3 months prior to screening or
boolean
C0020616 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1257987 (UMLS CUI [2,2])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1257987 (UMLS CUI [2,2])
Hypoglycemic Agents Absent
Item
untreated with any antihyperglycemic agent during 2 months prior to screening
boolean
C0020616 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent | Ketoacidosis
Item
history of type 1 diabetes or ketoacidosis
boolean
C0011854 (UMLS CUI [1])
C0220982 (UMLS CUI [2])
C0220982 (UMLS CUI [2])
Insulin regime Long-term
Item
history of long-term therapy with insulin
boolean
C0557978 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,2])
Body mass index
Item
bmi > 45 kg/m2
boolean
C1305855 (UMLS CUI [1])
Congestive heart failure
Item
known history of chf
boolean
C0018802 (UMLS CUI [1])
Liver Dysfunction
Item
impaired hepatic function
boolean
C0086565 (UMLS CUI [1])
Thiazolidinediones | Absent response to treatment | Intolerance to Thiazolidinediones
Item
history of prior treatment failure with, or intolerance of, a tzd
boolean
C1257987 (UMLS CUI [1])
C0438286 (UMLS CUI [2])
C1744706 (UMLS CUI [3,1])
C1257987 (UMLS CUI [3,2])
C0438286 (UMLS CUI [2])
C1744706 (UMLS CUI [3,1])
C1257987 (UMLS CUI [3,2])
Medical contraindication pioglitazone
Item
contraindication to treatment with pioglitazone
boolean
C1301624 (UMLS CUI [1,1])
C0071097 (UMLS CUI [1,2])
C0071097 (UMLS CUI [1,2])
Fibrates
Item
treatment with fibrates
boolean
C1449704 (UMLS CUI [1])
Oral hypoglycemic Absent | Dietary Modification Non-Insulin-Dependent Diabetes Mellitus | Exercise Modification Non-Insulin-Dependent Diabetes Mellitus | Therapeutic procedure failed
Item
if untreated with oral antihyperglycemic, considered to have failed diet and exercise modification as sole treatment for type 2 diabetes
boolean
C0359086 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0086153 (UMLS CUI [2,1])
C0011860 (UMLS CUI [2,2])
C0015259 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0011860 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C0231175 (UMLS CUI [4,2])
C0332197 (UMLS CUI [1,2])
C0086153 (UMLS CUI [2,1])
C0011860 (UMLS CUI [2,2])
C0015259 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0011860 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C0231175 (UMLS CUI [4,2])