ID

17214

Description

ARAMIS: Actions of tesaglitazaR on fAt Metabolism and Insulin Sensitivity; ODM derived from: https://clinicaltrials.gov/show/NCT00263965

Link

https://clinicaltrials.gov/show/NCT00263965

Keywords

Versions (1)
  1. 9/1/16 9/1/16 -
Uploaded on

September 1, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00263965

English

Eligibility Type 2 Diabetes NCT00263965

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
provision of a written informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
men or women who are 30-70 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
female patients: postmenopausal, hysterectomized
Description

female patients: postmenopausal, hysterectomized

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0020699
diagnosed with type 2 diabetes
Description

type 2 diabetes

Data type

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
Description

Treatment with diet alone or with a single oral antidiabetic agent or two oral antidiabetic agents

Data type

boolean

Alias
UMLS CUI [1]
C0011878
UMLS CUI [2]
C0359086
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes
Description

type 1 diabetes

Data type

boolean

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

NYHA

Data type

boolean

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

Insulin

Data type

boolean

Alias
UMLS CUI [1]
C0021641
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)
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

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1257987
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0033228
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0025598
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0360714
history of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
Description

drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia

Data type

boolean

Alias
UMLS CUI [1]
C0410220
UMLS CUI [2,1]
C0151576
UMLS CUI [2,2]
C0458082
UMLS CUI [3]
C0428321
UMLS CUI [4]
C0027947
creatinine levels above twice the normal range
Description

creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201975
creatine kinase above 3 times the upper limit of normal
Description

creatine kinase

Data type

boolean

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

investigational drug

Data type

boolean

Alias
UMLS CUI [1]
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
Description

Comorbidity compromising patient safety or successful participation in clinical study

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Similar models

Eligibility Type 2 Diabetes NCT00263965

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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 30-70 years of age
boolean
C0001779 (UMLS CUI [1])
female patients: postmenopausal, hysterectomized
Item
female patients: postmenopausal, hysterectomized
boolean
C0232970 (UMLS CUI [1])
C0020699 (UMLS CUI [2])
type 2 diabetes
Item
diagnosed with type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Treatment with diet alone or with a single oral antidiabetic agent or two oral antidiabetic agents
Item
treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents
boolean
C0011878 (UMLS CUI [1])
C0359086 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
type 1 diabetes
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
NYHA
Item
new york heart association heart failure class iii or iv
boolean
C1275491 (UMLS CUI [1])
Insulin
Item
treatment with chronic insulin
boolean
C0021641 (UMLS CUI [1])
hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist, fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitor
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])
C1257987 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0033228 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0025598 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0360714 (UMLS CUI [4,2])
drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia
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])
C0428321 (UMLS CUI [3])
C0027947 (UMLS CUI [4])
creatinine
Item
creatinine levels above twice the normal range
boolean
C0201975 (UMLS CUI [1])
creatine kinase
Item
creatine kinase above 3 times the upper limit of normal
boolean
C0201973 (UMLS CUI [1])
investigational drug
Item
received any investigational product in other clinical studies within 12 weeks
boolean
C0013230 (UMLS CUI [1])
Comorbidity compromising patient safety or successful participation in clinical study
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
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
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