Informações:
Falhas:
ID
19383
Descrição
Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00123643
Link
https://clinicaltrials.gov/show/NCT00123643
Palavras-chave
Versões (1)
- 27/12/2016 27/12/2016 -
Transferido a
27 de dezembro de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00123643
Eligibility Type 2 Diabetes Mellitus NCT00123643
- StudyEvent: Eligibility
Similar models
Eligibility Type 2 Diabetes Mellitus NCT00123643
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age
Item
age 25-75 years
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus disease length
Item
type 2 diabetes mellitus for less than or equal to 10 years
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,2])
Glycosylated hemoglobin A
Item
pre-screening hba1c > 6.5 %
boolean
C0019018 (UMLS CUI [1])
Plasma fasting glucose measurement | Metformin U/day Frequency
Item
screening 110 mg/dl < fasting plasma glucose < 240 mg/dl after 2 weeks of metformin 500 mg twice daily (b.i.d.)
boolean
C0583513 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0376249 (UMLS CUI [2,3])
C0025598 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0376249 (UMLS CUI [2,3])
Thiazolidinediones | Sulfonylurea | Washout Period
Item
thiazolidinedione or sulfonylurea use in previous 30 days (may undergo washout period of 30 days)
boolean
C1257987 (UMLS CUI [1])
C0038766 (UMLS CUI [2])
C1710661 (UMLS CUI [3])
C0038766 (UMLS CUI [2])
C1710661 (UMLS CUI [3])
Medical contraindication Thiazolidinediones | Medical contraindication Sulfonylurea
Item
known contraindications to use of thiazolidinedione or sulfonylurea
boolean
C1301624 (UMLS CUI [1,1])
C1257987 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0038766 (UMLS CUI [2,2])
C1257987 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0038766 (UMLS CUI [2,2])
Gender Contraceptive methods | Postmenopausal state | Female Sterilization
Item
female patients must be postmenopausal, surgically sterile, or using adequate contraception
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0700589 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
Hyperlipidemia Uncontrolled
Item
uncontrolled hyperlipidemia according to american heart association (aha) guidelines
boolean
C0020473 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,2])
Subcutaneous injection of insulin
Item
subcutaneous insulin use
boolean
C0586328 (UMLS CUI [1])
Elevated liver enzymes
Item
elevated liver enzymes (2.5 times the upper limit of the reference range)
boolean
C0235996 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine >160 mmol/l
boolean
C0201976 (UMLS CUI [1])
Anemia | Hemoglobin measurement | Gender
Item
anemia (hb <11 g/dl for men or <10 g/dl for women)
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0518015 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Body mass index
Item
body mass index (bmi) <22 or >42 kg/m2
boolean
C1305855 (UMLS CUI [1])
Ketoacidosis
Item
history of ketoacidosis
boolean
C0220982 (UMLS CUI [1])
Angina Pectoris | Heart failure New York Heart Association Classification
Item
angina/new york health academy class iii/iv cardiac insufficiency
boolean
C0002962 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Electrocardiogram: left ventricle hypertrophy Marked Evidence of
Item
electrocardiographic evidence of marked left ventricular hypertrophy
boolean
C0232306 (UMLS CUI [1,1])
C1706089 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
C1706089 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
Uncontrolled hypertension
Item
uncontrolled hypertension according to aha guidelines
boolean
C1868885 (UMLS CUI [1])
Hemoglobinopathy
Item
hemoglobinopathy
boolean
C0019045 (UMLS CUI [1])