ID

23281

Descripción

GALLEX 1 - Long Term Extension Study in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00252876

Link

https://clinicaltrials.gov/show/NCT00252876

Palabras clave

Versiones (1)
  1. 2/7/17 2/7/17 -
Subido en

2 de julio de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00252876

Inglés

Eligibility Type 2 Diabetes NCT00252876

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
provision of a written informed consent
Descripción

Informed Consent

Tipo de datos

boolean

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

Age

Tipo de datos

boolean

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

Postmenopausal state | Hysterectomy | Childbearing Potential Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0020699
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
completed the last two visits of randomized treatment period in gallant 2/22, 5, 7, 8 or 14 studies.
Descripción

Clinical Trial Specified | Patient Visit Quantity Completed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0205369
UMLS CUI [2,1]
C1512346
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0205197
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes
Descripción

Diabetes Mellitus, Insulin-Dependent

Tipo de datos

boolean

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

Heart failure New York Heart Association Classification

Tipo de datos

boolean

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

Insulin chronic

Tipo de datos

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)
Descripción

Hypersensitivity Peroxisome Proliferator-Activated Receptors | Intolerance to Peroxisome Proliferator-Activated Receptors | Hypersensitivity Actos | Intolerance to Actos | Hypersensitivity Avandia | Intolerance to Avandia | Hypersensitivity Fenofibrate | Intolerance to Fenofibrate | Hypersensitivity Metformin | Intolerance to Metformin | Hypersensitivity Statins | Intolerance to Statins

Tipo de datos

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]
C1744706
UMLS CUI [4,2]
C0875954
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0875967
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0875967
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0033228
UMLS CUI [8,1]
C1744706
UMLS CUI [8,2]
C0033228
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C0025598
UMLS CUI [10,1]
C1744706
UMLS CUI [10,2]
C0025598
UMLS CUI [11,1]
C0020517
UMLS CUI [11,2]
C0360714
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)
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0410220
UMLS CUI [2,1]
C0151576
UMLS CUI [2,2]
C0458082
UMLS CUI [3]
C0235996
UMLS CUI [4]
C0027947
UMLS CUI [5]
C0948695
creatinine levels above twice the normal range
Descripción

Serum creatinine raised

Tipo de datos

boolean

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

Elevated creatine kinase

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151576
previous enrollment in this long-term extension study
Descripción

Study Subject Participation Status | Clinical Trial Extension Long-term

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0231448
UMLS CUI [2,3]
C0443252
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
Descripción

Abnormality Clinical Significance compromises patient safety | Abnormality Clinical Significance compromises Study Subject Participation Status | Physical examination abnormal | Laboratory test result abnormal | Electrocardiogram abnormal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C1113679
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C2826293
UMLS CUI [2,3]
C2945640
UMLS CUI [2,4]
C2348568
UMLS CUI [3]
C0747585
UMLS CUI [4]
C0438215
UMLS CUI [5]
C0522055
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Similar models

Eligibility Type 2 Diabetes NCT00252876

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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
C0232970 (UMLS CUI [1])
C0020699 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Clinical Trial Specified | Patient Visit Quantity Completed
Item
completed the last two visits of randomized treatment period in gallant 2/22, 5, 7, 8 or 14 studies.
boolean
C0008976 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C1512346 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
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 chronic
Item
treatment with chronic insulin
boolean
C0021641 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Hypersensitivity Peroxisome Proliferator-Activated Receptors | Intolerance to Peroxisome Proliferator-Activated Receptors | Hypersensitivity Actos | Intolerance to Actos | Hypersensitivity Avandia | Intolerance to Avandia | Hypersensitivity Fenofibrate | Intolerance to Fenofibrate | Hypersensitivity Metformin | Intolerance to Metformin | Hypersensitivity Statins | Intolerance to Statins
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])
C1744706 (UMLS CUI [4,1])
C0875954 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0875967 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0875967 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0033228 (UMLS CUI [7,2])
C1744706 (UMLS CUI [8,1])
C0033228 (UMLS CUI [8,2])
C0020517 (UMLS CUI [9,1])
C0025598 (UMLS CUI [9,2])
C1744706 (UMLS CUI [10,1])
C0025598 (UMLS CUI [10,2])
C0020517 (UMLS CUI [11,1])
C0360714 (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 | 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])
C0027947 (UMLS CUI [4])
C0948695 (UMLS CUI [5])
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 | Clinical Trial Extension Long-term
Item
previous enrollment in this long-term extension study
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0231448 (UMLS CUI [2,2])
C0443252 (UMLS CUI [2,3])
Abnormality Clinical Significance compromises patient safety | Abnormality Clinical Significance compromises Study Subject Participation Status | Physical examination abnormal | Laboratory test result abnormal | Electrocardiogram abnormal
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])
C2945640 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C1704258 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0747585 (UMLS CUI [3])
C0438215 (UMLS CUI [4])
C0522055 (UMLS CUI [5])
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