ID
4881
Description
ODM derived from http://clinicaltrials.gov/show/NCT00261352
Link
http://clinicaltrials.gov/show/NCT00261352
Keywords
Versions (2)
- 2/24/12 2/24/12 -
- 4/13/14 4/13/14 - Julian Varghese
Uploaded on
April 13, 2014
DOI
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License
Creative Commons BY 4.0
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Eligibility NCT00261352 Type 2 Diabetes
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Description
Type 1 diabetes
Data type
boolean
Description
NYHA Class III or IV
Data type
boolean
Description
Treatment with insulin
Data type
boolean
Description
hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist, fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor
Data type
boolean
Description
drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia
Data type
boolean
Description
Creatinine levels abnormal
Data type
boolean
Description
Received any investigational product in other clinical studies
Data type
boolean
Description
Any clinically significant abnormality, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
Data type
boolean
Description
Medical Concepts
Description
Age
Data type
integer
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 397669002
Description
Diagnosis
Data type
string
Alias
- UMLS CUI
- C0011900
- SNOMED CT 2010_0731
- 439401001
- LOINC Version 232
- MTHU008876
Description
Informed Consent
Data type
string
Alias
- UMLS CUI
- C0021430
Description
Postmenopause
Data type
string
Alias
- UMLS CUI
- C0206159
- MedDRA 13.1
- 10051775
Description
Hysterectomy
Data type
string
Alias
- UMLS CUI
- C0020699
- SNOMED CT 2010_0731
- 236886002
- MedDRA 13.1
- 10021151
Description
Contraception
Data type
string
Alias
- UMLS CUI
- C0700589
- SNOMED CT 2010_0731
- 146680009
- MedDRA 13.1
- 10010808
Description
Diabetes mellitus type 2
Data type
string
Alias
- UMLS CUI
- C0011860
- SNOMED CT 2010_0731
- 44054006
- MedDRA 13.1
- 10012613
- ICD-10-CM Version 2010
- E08-E13
Description
Diet
Data type
string
Alias
- UMLS CUI
- C0012155
- SNOMED CT 2010_0731
- 41829006
Description
Anti-diabetic Agent
Data type
string
Alias
- UMLS CUI
- C0935929
- SNOMED CT 2010_0731
- 373245004
Description
Diabetes mellitus type 1
Data type
string
Alias
- UMLS CUI
- C0011854
- SNOMED CT 2010_0731
- 46635009
- MedDRA 13.1
- 10067584
- LOINC Version 232
- MTHU020217
- ICD-10-CM Version 2010
- E10
Description
Heart failure
Data type
string
Alias
- UMLS CUI
- C0018801
- SNOMED CT 2010_0731
- 155374007
- MedDRA 13.1
- 10019279
- ICD-9-CM Version 2011
- 428
- CTCAE Version 4.03
- E10124
Description
NYHA Class III
Data type
string
Alias
- UMLS CUI
- C1319795
- SNOMED CT 2010_0731
- 420913000
- MedDRA 13.1
- 10064081
Description
NYHA Class IV
Data type
string
Alias
- UMLS CUI
- C1319796
- SNOMED CT 2010_0731
- 422293003
- MedDRA 13.1
- 10064082
Description
Therapeutic Insulin
Data type
string
Alias
- UMLS CUI
- C0557978
Description
Insulin
Data type
string
Alias
- UMLS CUI
- C0021641
- SNOMED CT 2010_0731
- 67866001
- LOINC Version 232
- MTHU002108
Description
chronic
Data type
string
Alias
- UMLS CUI
- C0205191
- SNOMED CT 2010_0731
- 90734009
Description
Allergy
Data type
string
Alias
- UMLS CUI
- C0020517
- SNOMED CT 2010_0731
- 257550005
- ICD-10-CM Version 2010
- T78.40
Description
intolerance to substance
Data type
string
Alias
- UMLS CUI
- C1744706
Description
peroxisome
Data type
string
Alias
- UMLS CUI
- C0752063
- SNOMED CT 2010_0731
- 11191006
Description
Fenofibrate
Data type
string
Alias
- UMLS CUI
- C0033228
- SNOMED CT 2010_0731
- 386879008
Description
Metformin
Data type
string
Alias
- UMLS CUI
- C0025598
- SNOMED CT 2010_0731
- 372567009
- LOINC Version 232
- MTHU016062
Description
Actos
Data type
string
Alias
- UMLS CUI
- C0872972
- SNOMED CT 2010_0731
- 116097005
Description
Avandia
Data type
string
Alias
- UMLS CUI
- C0795660
- SNOMED CT 2010_0731
- 116096001
Description
statin
Data type
string
Alias
- UMLS CUI
- C0360714
- SNOMED CT 2010_0731
- 372912004
Description
Myopathy
Data type
string
Alias
- UMLS CUI
- C0026848
- SNOMED CT 2010_0731
- 129565002
- MedDRA 13.1
- 10028641
- ICD-10-CM Version 2010
- G72.9
- ICD-9-CM Version 2011
- 359.9
Description
Abnormalities, Drug-Induced
Data type
string
Alias
- UMLS CUI
- C0000771
Description
Creatine Kinase
Data type
string
Alias
- UMLS CUI
- C0010287
- SNOMED CT 2010_0731
- 75828004
- LOINC Version 232
- MTHU006937
Description
Elevated liver enzyme levels
Data type
string
Alias
- UMLS CUI
- C0857093
- MedDRA 13.1
- 10014480
Description
Neutrophil count decreased
Data type
string
Alias
- UMLS CUI
- C0853697
- MedDRA 13.1
- 10029366
- CTCAE Version 4.03
- E12198
Description
Creatinine abnormal
Data type
string
Alias
- UMLS CUI
- C0740471
- MedDRA 13.1
- 10011359
Description
Clinical Research
Data type
string
Alias
- UMLS CUI
- C0008972
Description
Physical Examination
Data type
string
Alias
- UMLS CUI
- C0031809
- SNOMED CT 2010_0731
- 5880005
- MedDRA 13.1
- 10034986
- LOINC Version 232
- MTHU028014
- ICD-9-CM Version 2011
- 89.7
Description
Laboratory Procedures
Data type
string
Alias
- UMLS CUI
- C0022885
- SNOMED CT 2010_0731
- 15220000
- MedDRA 13.1
- 10059938
Description
ECG
Data type
string
Alias
- UMLS CUI
- C1623258
- SNOMED CT 2010_0731
- 46825001
- MedDRA 13.1
- 10014084
Description
patient safety
Data type
string
Alias
- UMLS CUI
- C1113679
Similar models
Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2010_0731)
10051775 (MedDRA 13.1)
236886002 (SNOMED CT 2010_0731)
10021151 (MedDRA 13.1)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
44054006 (SNOMED CT 2010_0731)
10012613 (MedDRA 13.1)
E08-E13 (ICD-10-CM Version 2010)
41829006 (SNOMED CT 2010_0731)
373245004 (SNOMED CT 2010_0731)
46635009 (SNOMED CT 2010_0731)
10067584 (MedDRA 13.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
155374007 (SNOMED CT 2010_0731)
10019279 (MedDRA 13.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE Version 4.03)
420913000 (SNOMED CT 2010_0731)
10064081 (MedDRA 13.1)
422293003 (SNOMED CT 2010_0731)
10064082 (MedDRA 13.1)
90734009 (SNOMED CT 2010_0731)
257550005 (SNOMED CT 2010_0731)
T78.40 (ICD-10-CM Version 2010)
11191006 (SNOMED CT 2010_0731)
386879008 (SNOMED CT 2010_0731)
116097005 (SNOMED CT 2010_0731)
116096001 (SNOMED CT 2010_0731)
372912004 (SNOMED CT 2010_0731)
129565002 (SNOMED CT 2010_0731)
10028641 (MedDRA 13.1)
G72.9 (ICD-10-CM Version 2010)
359.9 (ICD-9-CM Version 2011)
10014480 (MedDRA 13.1)
10029366 (MedDRA 13.1)
E12198 (CTCAE Version 4.03)
10011359 (MedDRA 13.1)
5880005 (SNOMED CT 2010_0731)
10034986 (MedDRA 13.1)
MTHU028014 (LOINC Version 232)
89.7 (ICD-9-CM Version 2011)
15220000 (SNOMED CT 2010_0731)
10059938 (MedDRA 13.1)
46825001 (SNOMED CT 2010_0731)
10014084 (MedDRA 13.1)