ID

17229

Beskrivning

GALLANT 5 Tesaglitazar Versus Metformin; ODM derived from: https://clinicaltrials.gov/show/NCT00214591

Länk

https://clinicaltrials.gov/show/NCT00214591

Nyckelord

Versioner (1)
  1. 2016-09-01 2016-09-01 -
Uppladdad den

1 september 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00214591

Engelsk

Eligibility Diabetes Mellitus, Type 2 NCT00214591

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
provision of a written informed consent
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
men or women who are ³18 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
Beskrivning

Gender | Postmenopausal state | Hysterectomy | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0020699
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
diagnosed with type 2 diabetes
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents
Beskrivning

Diet therapy | Oral hypoglycemic Single | Oral hypoglycemic Quantity Low dose

Datatyp

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2,1]
C0359086
UMLS CUI [2,2]
C0205171
UMLS CUI [3,1]
C0359086
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0445550
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes
Beskrivning

Diabetes Mellitus, Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
new york heart association heart failure class iii or iv
Beskrivning

New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C1275491
treatment with chronic insulin
Beskrivning

Insulin chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0205191
history of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like actos or avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitor (statin)
Beskrivning

Hypersensitivity Peroxisome Proliferator-Activated Receptor agonists | Intolerance to Peroxisome Proliferator-Activated Receptor agonists | Actos | Avandia | Fenofibrate | Metformin | statin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0166418
UMLS CUI [1,3]
C0243192
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0166418
UMLS CUI [2,3]
C0243192
UMLS CUI [3]
C0875954
UMLS CUI [4]
C0875967
UMLS CUI [5]
C0033228
UMLS CUI [6]
C0025598
UMLS CUI [7]
C0360714
history of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
Beskrivning

Drug-induced myopathy | Elevated creatine kinase Drug-induced | Elevated liver enzymes Drug-induced | Drug-induced neutropenia | White blood cell count low

Datatyp

boolean

Alias
UMLS CUI [1]
C0410220
UMLS CUI [2,1]
C0151576
UMLS CUI [2,2]
C0458082
UMLS CUI [3,1]
C0235996
UMLS CUI [3,2]
C0458082
UMLS CUI [4]
C0272178
UMLS CUI [5]
C0948695
creatinine levels above twice the normal range
Beskrivning

creatinine level

Datatyp

boolean

Alias
UMLS CUI [1]
C0428279
creatine kinase above 3 times the upper limit of normal
Beskrivning

Creatine kinase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201973
received any investigational product in other clinical studies within 12 weeks
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
Beskrivning

Abnormality Clinically Significant compromises patient safety | Abnormality Clinically Significant Compliance behavior Limited | Physical Examination | Laboratory Procedures | Electrocardiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C1113679
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C2985739
UMLS CUI [2,3]
C1321605
UMLS CUI [2,4]
C0439801
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0022885
UMLS CUI [5]
C1623258
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00214591

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
provision of a written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
men or women who are ³18 years of age
boolean
C0001779 (UMLS CUI [1])
Gender | Postmenopausal state | Hysterectomy | Childbearing Potential Contraceptive methods
Item
female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosed with type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Diet therapy | Oral hypoglycemic Single | Oral hypoglycemic Quantity Low dose
Item
treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents
boolean
C0012159 (UMLS CUI [1])
C0359086 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
C0359086 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0445550 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
New York Heart Association Classification
Item
new york heart association heart failure class iii or iv
boolean
C1275491 (UMLS CUI [1])
Insulin chronic
Item
treatment with chronic insulin
boolean
C0021641 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Hypersensitivity Peroxisome Proliferator-Activated Receptor agonists | Intolerance to Peroxisome Proliferator-Activated Receptor agonists | Actos | Avandia | Fenofibrate | Metformin | statin
Item
history of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like actos or avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitor (statin)
boolean
C0020517 (UMLS CUI [1,1])
C0166418 (UMLS CUI [1,2])
C0243192 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0166418 (UMLS CUI [2,2])
C0243192 (UMLS CUI [2,3])
C0875954 (UMLS CUI [3])
C0875967 (UMLS CUI [4])
C0033228 (UMLS CUI [5])
C0025598 (UMLS CUI [6])
C0360714 (UMLS CUI [7])
Drug-induced myopathy | Elevated creatine kinase Drug-induced | Elevated liver enzymes Drug-induced | Drug-induced neutropenia | White blood cell count low
Item
history of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
boolean
C0410220 (UMLS CUI [1])
C0151576 (UMLS CUI [2,1])
C0458082 (UMLS CUI [2,2])
C0235996 (UMLS CUI [3,1])
C0458082 (UMLS CUI [3,2])
C0272178 (UMLS CUI [4])
C0948695 (UMLS CUI [5])
creatinine level
Item
creatinine levels above twice the normal range
boolean
C0428279 (UMLS CUI [1])
Creatine kinase measurement
Item
creatine kinase above 3 times the upper limit of normal
boolean
C0201973 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
received any investigational product in other clinical studies within 12 weeks
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Abnormality Clinically Significant compromises patient safety | Abnormality Clinically Significant Compliance behavior Limited | Physical Examination | Laboratory Procedures | Electrocardiography
Item
any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C1704258 (UMLS CUI [2,1])
C2985739 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C0439801 (UMLS CUI [2,4])
C0031809 (UMLS CUI [3])
C0022885 (UMLS CUI [4])
C1623258 (UMLS CUI [5])
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