Information:
Fel:
ID
16086
Beskrivning
Effects of Dapagliflozin on Epicardial Fat in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02235298
Länk
https://clinicaltrials.gov/show/NCT02235298
Nyckelord
Versioner (1)
- 2016-06-28 2016-06-28 -
Uppladdad den
28 juni 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT02235298
Eligibility Type 2 Diabetes NCT02235298
- StudyEvent: Eligibility
Similar models
Eligibility Type 2 Diabetes NCT02235298
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Diabetes Mellitus, Non-Insulin-Dependent
Item
• type 2 diabetes, as defined by ada criteria
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c ≤ 8% measured at least 1 week prior to the study
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi ≥27 kg/m2
boolean
C1305855 (UMLS CUI [1])
Therapeutic procedure Metformin pre treatment
Item
pre-treatment with metformin as monotherapy
boolean
C0087111 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
C2709094 (UMLS CUI [1,3])
C0025598 (UMLS CUI [1,2])
C2709094 (UMLS CUI [1,3])
Age
Item
age > 18 and < 70 years old
boolean
C0001779 (UMLS CUI [1])
Medical contraindication Farxiga
Item
• known contra-indications to farxiga, in accordance with risks and safety information included in the latest updated prescribing information
boolean
C1301624 (UMLS CUI [1,1])
C3700957 (UMLS CUI [1,2])
C3700957 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes, as defined by american diabetes association (ada) criteria
boolean
C0011854 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent Treated
Item
insulin dependent or treated type 2 diabetes
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0011860 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
Sodium-Glucose Transporter 2 Inhibitors | GLP-1 Analogue | Dipeptidyl Peptidase 4 Inhibitor
Item
current use of other sglt2 inhibitors, glp- 1 analogs or dpp4 inhibitors
boolean
C3665047 (UMLS CUI [1])
C3273809 (UMLS CUI [2])
C3537161 (UMLS CUI [3])
C3273809 (UMLS CUI [2])
C3537161 (UMLS CUI [3])
Glomerular Filtration Rate
Item
glomerular filtration rate (gfr) < 60 ml/min/1.73 m2
boolean
C0017654 (UMLS CUI [1])
Poor glycemic control | patient retention Long-term
Item
patients with poor glycemic control will be excluded to maximize long-term patient retention without need
boolean
C0342299 (UMLS CUI [1])
C0679857 (UMLS CUI [2,1])
C0443252 (UMLS CUI [2,2])
C0679857 (UMLS CUI [2,1])
C0443252 (UMLS CUI [2,2])
Diabetic Ketoacidosis
Item
history of diabetes ketoacidosis
boolean
C0011880 (UMLS CUI [1])
Sign or Symptom Heart failure Severe
Item
clinical signs or symptoms of new york heart association (nyha) class iii-iv heart failure
boolean
C3540840 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0018801 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Chronic liver disease
Item
clinical or laboratory evidences of chronic active liver diseases
boolean
C0341439 (UMLS CUI [1])
Acute infectious disease | Chronic infectious disease
Item
acute or chronic infective diseases
boolean
C0275518 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C0151317 (UMLS CUI [2])
Malignant Neoplasms | Chemotherapy
Item
cancer or chemotherapy
boolean
C0006826 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0392920 (UMLS CUI [2])
systemic steroids
Item
current use of systemic corticosteroids or in the 3 months prior this study
boolean
C2825233 (UMLS CUI [1])
Hypersensitivity dapagliflozin | Hypersensitivity dapagliflozin Excipient | Hypersensitivity dapagliflozin Pharmaceutical Preparations Related
Item
known or suspected allergy to dapaglifozin, excipients, or related products
boolean
C0020517 (UMLS CUI [1,1])
C2353951 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2353951 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C2353951 (UMLS CUI [3,2])
C0013227 (UMLS CUI [3,3])
C0439849 (UMLS CUI [3,4])
C2353951 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2353951 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C2353951 (UMLS CUI [3,2])
C0013227 (UMLS CUI [3,3])
C0439849 (UMLS CUI [3,4])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnant, breast-feeding or the intention of becoming pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Childbearing Potential Contraceptive methods Not used
Item
females of childbearing potential who are not using adequate contraceptive methods
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0445107 (UMLS CUI [1,3])
C0700589 (UMLS CUI [1,2])
C0445107 (UMLS CUI [1,3])