ID

19423

Descrição

GALLANT 8 Tesaglitazar Add-on to Metformin; ODM derived from: https://clinicaltrials.gov/show/NCT00251953

Link

https://clinicaltrials.gov/show/NCT00251953

Palavras-chave

Versões (1)
  1. 30/12/2016 30/12/2016 -
Transferido a

30 de dezembro de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00251953

Inglês

Eligibility Type 2 Diabetes NCT00251953

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
provision of a written informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
men or women who are >=18 years of age
Descrição

Age

Tipo de dados

boolean

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

Gender | Postmenopausal | Hysterectomy | Childbearing Potential Contraceptive methods

Tipo de dados

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
Descrição

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de dados

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
Descrição

Diet therapy | Antidiabetic agent Oral Single | Antidiabetics Oral Quantity | Antidiabetics Oral Low dose

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0205171
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0935929
UMLS CUI [4,2]
C1527415
UMLS CUI [4,3]
C0445550
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes
Descrição

Diabetes Mellitus, Insulin-Dependent

Tipo de dados

boolean

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

Heart failure New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
treatment with chronic insulin
Descrição

Insulin regime chronic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0557978
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)
Descrição

Hypersensitivity Peroxisome Proliferator-Activated Receptors | intolerance to Peroxisome Proliferator-Activated Receptors | Hypersensitivity Actos | Hypersensitivity Avandia | Fenofibrate allergy | Metformin allergy | Hypersensitivity Hydroxymethylglutaryl-CoA Reductase Inhibitors | intolerance to Actos | intolerance to Avandia | intolerance to Fenofibrate | intolerance to Metformin | intolerance to Hydroxymethylglutaryl-CoA Reductase Inhibitors

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0166418
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0166418
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0875954
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0875967
UMLS CUI [5]
C0571869
UMLS CUI [6]
C0571648
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0360714
UMLS CUI [8,1]
C1744706
UMLS CUI [8,2]
C0875954
UMLS CUI [9,1]
C1744706
UMLS CUI [9,2]
C0875967
UMLS CUI [10,1]
C1744706
UMLS CUI [10,2]
C0033228
UMLS CUI [11,1]
C1744706
UMLS CUI [11,2]
C0025598
UMLS CUI [12,1]
C1744706
UMLS CUI [12,2]
C0360714
history of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
Descrição

Drug-induced myopathy | Elevated creatine kinase Drug-induced | Elevated liver enzymes Drug-induced | Neutropenia Drug-induced

Tipo de dados

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 [4,1]
C0027947
UMLS CUI [4,2]
C0458082
creatinine levels above twice the normal range
Descrição

Serum creatinine raised

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0700225
creatine kinase above 3 times the upper limit of normal
Descrição

Elevated creatine kinase

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151576
received any investigational product in other clinical studies within 12 weeks
Descrição

Study Subject Participation Status | Investigational New Drugs

Tipo de dados

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
Descrição

Abnormality Clinical Significance Affecting Patient safety | Abnormality Clinical Significance Limiting Study Subject Participation Status | Physical Examination | Laboratory Procedures | Electrocardiography

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C1113679
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C2826293
UMLS CUI [2,3]
C0439801
UMLS CUI [2,4]
C2348568
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0022885
UMLS CUI [5]
C1623258
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Similar models

Eligibility Type 2 Diabetes NCT00251953

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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 >=18 years of age
boolean
C0001779 (UMLS CUI [1])
Gender | Postmenopausal | 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 | Antidiabetic agent Oral Single | Antidiabetics Oral Quantity | Antidiabetics Oral 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])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0445550 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Heart failure New York Heart Association Classification
Item
new york heart association heart failure class iii or iv
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Insulin regime chronic
Item
treatment with chronic insulin
boolean
C0557978 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Hypersensitivity Peroxisome Proliferator-Activated Receptors | intolerance to Peroxisome Proliferator-Activated Receptors | Hypersensitivity Actos | Hypersensitivity Avandia | Fenofibrate allergy | Metformin allergy | Hypersensitivity Hydroxymethylglutaryl-CoA Reductase Inhibitors | intolerance to Actos | intolerance to Avandia | intolerance to Fenofibrate | intolerance to Metformin | intolerance to Hydroxymethylglutaryl-CoA Reductase Inhibitors
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])
C1744706 (UMLS CUI [2,1])
C0166418 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0875954 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0875967 (UMLS CUI [4,2])
C0571869 (UMLS CUI [5])
C0571648 (UMLS CUI [6])
C0020517 (UMLS CUI [7,1])
C0360714 (UMLS CUI [7,2])
C1744706 (UMLS CUI [8,1])
C0875954 (UMLS CUI [8,2])
C1744706 (UMLS CUI [9,1])
C0875967 (UMLS CUI [9,2])
C1744706 (UMLS CUI [10,1])
C0033228 (UMLS CUI [10,2])
C1744706 (UMLS CUI [11,1])
C0025598 (UMLS CUI [11,2])
C1744706 (UMLS CUI [12,1])
C0360714 (UMLS CUI [12,2])
Drug-induced myopathy | Elevated creatine kinase Drug-induced | Elevated liver enzymes Drug-induced | Neutropenia Drug-induced
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])
C0027947 (UMLS CUI [4,1])
C0458082 (UMLS CUI [4,2])
Serum creatinine raised
Item
creatinine levels above twice the normal range
boolean
C0700225 (UMLS CUI [1])
Elevated creatine kinase
Item
creatine kinase above 3 times the upper limit of normal
boolean
C0151576 (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 Clinical Significance Affecting Patient safety | Abnormality Clinical Significance Limiting Study Subject Participation Status | 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])
C2826293 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C1704258 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0031809 (UMLS CUI [3])
C0022885 (UMLS CUI [4])
C1623258 (UMLS CUI [5])
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