ID

17262

Description

Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00499707

Lien

https://clinicaltrials.gov/show/NCT00499707

Mots-clés

Versions (1)
  1. 02/09/2016 02/09/2016 -
Téléchargé le

2 septembre 2016

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00499707

Anglais

Eligibility Diabetes Mellitus, Type 2 NCT00499707

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 to 70 years of age
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
clinical diagnosis of type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Type de données

boolean

Alias
UMLS CUI [1]
C0011860
hba1c >7.5% to 11%
Description

Glycosylated hemoglobin A

Type de données

boolean

Alias
UMLS CUI [1]
C0019018
fpg <270mg/dl (15mmol)
Description

Plasma fasting glucose measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0583513
current treatment with diet and/or exercise alone, or no more than 15 days of an anti-diabetic medication or insulin within 12 weeks of screening
Description

Diet therapy | Physical therapy exercises | Antidiabetics | Insulin

Type de données

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2]
C0452240
UMLS CUI [3]
C0935929
UMLS CUI [4]
C0021641
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically significant renal or hepatic disease
Description

Kidney Disease Clinical Significance | Liver disease Clinical Significance

Type de données

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C2826293
presence of anemia
Description

Anemia

Type de données

boolean

Alias
UMLS CUI [1]
C0002871
presence of unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring therapy
Description

Angina, Unstable | Angina Pectoris Severe | Coronary artery insufficiency | Congestive heart failure Requirement Therapeutic procedure

Type de données

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0542052
UMLS CUI [4,1]
C0018802
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0087111
systolic blood pressure >170mmhg or diastolic blood pressure >100mmhg, while on anti-hypertensive treatment
Description

Systolic Pressure | Diastolic blood pressure | Antihypertensive therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
UMLS CUI [3]
C0585941
chronic disease requiring intermittent or chronic treatment with corticosteroids
Description

Chronic disease Requirement Adrenal Cortex Hormones Therapeutic procedure Intermittent | Chronic disease Requirement Adrenal Cortex Hormones Therapeutic procedure chronic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0001617
UMLS CUI [1,4]
C0087111
UMLS CUI [1,5]
C0205267
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0001617
UMLS CUI [2,4]
C0087111
UMLS CUI [2,5]
C0205191
any female lactating, pregnant, or planning to become pregnant
Description

Breast Feeding | Pregnancy | Pregnancy, Planned

Type de données

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0032992
history of hepatocellular reaction, severe edema or a medically serious fluid related event associated with any thiazolidinedione
Description

HEPATOCELLULAR REACTION Associated with Thiazolidinediones | Severe edema Associated with Thiazolidinediones | Fluid disorder Serious Associated with Thiazolidinediones

Type de données

boolean

Alias
UMLS CUI [1,1]
C0518991
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C1257987
UMLS CUI [2,1]
C0341950
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C1257987
UMLS CUI [3,1]
C2364164
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0332281
UMLS CUI [3,4]
C1257987
presence of acute or chronic metabolic acidosis
Description

Metabolic acidosis | Chronic metabolic acidosis

Type de données

boolean

Alias
UMLS CUI [1]
C0220981
UMLS CUI [2]
C0740749
history of diabetic ketoacidosis
Description

Diabetic Ketoacidosis

Type de données

boolean

Alias
UMLS CUI [1]
C0011880
Retour au début de la page

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00499707

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 to 70 years of age
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
clinical diagnosis of type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hba1c >7.5% to 11%
boolean
C0019018 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fpg <270mg/dl (15mmol)
boolean
C0583513 (UMLS CUI [1])
Diet therapy | Physical therapy exercises | Antidiabetics | Insulin
Item
current treatment with diet and/or exercise alone, or no more than 15 days of an anti-diabetic medication or insulin within 12 weeks of screening
boolean
C0012159 (UMLS CUI [1])
C0452240 (UMLS CUI [2])
C0935929 (UMLS CUI [3])
C0021641 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Kidney Disease Clinical Significance | Liver disease Clinical Significance
Item
clinically significant renal or hepatic disease
boolean
C0022658 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
Anemia
Item
presence of anemia
boolean
C0002871 (UMLS CUI [1])
Angina, Unstable | Angina Pectoris Severe | Coronary artery insufficiency | Congestive heart failure Requirement Therapeutic procedure
Item
presence of unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring therapy
boolean
C0002965 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0542052 (UMLS CUI [3])
C0018802 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
Systolic Pressure | Diastolic blood pressure | Antihypertensive therapy
Item
systolic blood pressure >170mmhg or diastolic blood pressure >100mmhg, while on anti-hypertensive treatment
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0585941 (UMLS CUI [3])
Chronic disease Requirement Adrenal Cortex Hormones Therapeutic procedure Intermittent | Chronic disease Requirement Adrenal Cortex Hormones Therapeutic procedure chronic
Item
chronic disease requiring intermittent or chronic treatment with corticosteroids
boolean
C0008679 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0001617 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0205267 (UMLS CUI [1,5])
C0008679 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0001617 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
C0205191 (UMLS CUI [2,5])
Breast Feeding | Pregnancy | Pregnancy, Planned
Item
any female lactating, pregnant, or planning to become pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
HEPATOCELLULAR REACTION Associated with Thiazolidinediones | Severe edema Associated with Thiazolidinediones | Fluid disorder Serious Associated with Thiazolidinediones
Item
history of hepatocellular reaction, severe edema or a medically serious fluid related event associated with any thiazolidinedione
boolean
C0518991 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C1257987 (UMLS CUI [1,3])
C0341950 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C1257987 (UMLS CUI [2,3])
C2364164 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0332281 (UMLS CUI [3,3])
C1257987 (UMLS CUI [3,4])
Metabolic acidosis | Chronic metabolic acidosis
Item
presence of acute or chronic metabolic acidosis
boolean
C0220981 (UMLS CUI [1])
C0740749 (UMLS CUI [2])
Diabetic Ketoacidosis
Item
history of diabetic ketoacidosis
boolean
C0011880 (UMLS CUI [1])
Retour au début de la page 

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