ID

32757

Description

Thiazolidinediones Or Sulphonylureas and Cardiovascular Accidents.Intervention Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00700856

Link

https://clinicaltrials.gov/show/NCT00700856

Keywords

Versions (1)
  1. 11/14/18 11/14/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 14, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00700856

English

Eligibility Type 2 Diabetes Mellitus NCT00700856

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females, age 50-75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
type 2 diabetes of at least 2 years duration
Description

Non-Insulin-Dependent Diabetes Mellitus Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0449238
bmi 20-45 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
stable treatment for the last two months with metformin in monotherapy (at least 2 gr/die)
Description

Metformin Stable U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0456683
hba1c >=7.0% and <=9.0%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
previous treatment with thiazolidinediones in the last six months
Description

Thiazolidinediones

Data type

boolean

Alias
UMLS CUI [1]
C1257987
contraindication/intolerance to metformin or sus or tzds
Description

Medical contraindication Metformin | Medical contraindication Sulfonylureas | Medical contraindication Thiazolidinediones | Intolerance to Metformin | Intolerance to Sulfonylureas | Intolerance to Thiazolidinediones

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0025598
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0038766
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C1257987
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0025598
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C0038766
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C1257987
documented coronary or cerebrovascular events in the previous 3 months
Description

Event Coronary | Event Cerebrovascular

Data type

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1522318
UMLS CUI [2,1]
C0441471
UMLS CUI [2,2]
C1880018
serum creatinine > 1.5 mg/dl
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
history of congestive heart failure, nyha i or higher
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
chronic use of glucocorticoids
Description

Glucocorticoids chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0017710
UMLS CUI [1,2]
C0205191
ischemic ulcer or gangrene
Description

Ischemic ulcer | Gangrene

Data type

boolean

Alias
UMLS CUI [1]
C0265000
UMLS CUI [2]
C0017086
liver cirrhosis or severe hepatic dysfunction (alt increase of 2.5 times the upper normal limit)
Description

Liver Cirrhosis | Liver Dysfunction Severe | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2,1]
C0086565
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0151905
pregnancy or breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
cancer, substance abuse, or any health problem that may interfere with the compliance to the study protocol or limit life expectancy
Description

Malignant Neoplasms | Substance Use Disorders | Medical Problem Interferes with Protocol Compliance | Medical Problem Limiting Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0038586
UMLS CUI [3,1]
C1254481
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C1254481
UMLS CUI [4,2]
C0439801
UMLS CUI [4,3]
C0023671
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00700856

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males and females, age 50-75 years
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Duration
Item
type 2 diabetes of at least 2 years duration
boolean
C0011860 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Body mass index
Item
bmi 20-45 kg/m2
boolean
C1305855 (UMLS CUI [1])
Metformin Stable U/day
Item
stable treatment for the last two months with metformin in monotherapy (at least 2 gr/die)
boolean
C0025598 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Hemoglobin A1c measurement
Item
hba1c >=7.0% and <=9.0%
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Thiazolidinediones
Item
previous treatment with thiazolidinediones in the last six months
boolean
C1257987 (UMLS CUI [1])
Medical contraindication Metformin | Medical contraindication Sulfonylureas | Medical contraindication Thiazolidinediones | Intolerance to Metformin | Intolerance to Sulfonylureas | Intolerance to Thiazolidinediones
Item
contraindication/intolerance to metformin or sus or tzds
boolean
C1301624 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0038766 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C1257987 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0025598 (UMLS CUI [4,2])
C1744706 (UMLS CUI [5,1])
C0038766 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C1257987 (UMLS CUI [6,2])
Event Coronary | Event Cerebrovascular
Item
documented coronary or cerebrovascular events in the previous 3 months
boolean
C0441471 (UMLS CUI [1,1])
C1522318 (UMLS CUI [1,2])
C0441471 (UMLS CUI [2,1])
C1880018 (UMLS CUI [2,2])
Creatinine measurement, serum
Item
serum creatinine > 1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification
Item
history of congestive heart failure, nyha i or higher
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Glucocorticoids chronic
Item
chronic use of glucocorticoids
boolean
C0017710 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Ischemic ulcer | Gangrene
Item
ischemic ulcer or gangrene
boolean
C0265000 (UMLS CUI [1])
C0017086 (UMLS CUI [2])
Liver Cirrhosis | Liver Dysfunction Severe | Alanine aminotransferase increased
Item
liver cirrhosis or severe hepatic dysfunction (alt increase of 2.5 times the upper normal limit)
boolean
C0023890 (UMLS CUI [1])
C0086565 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0151905 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms | Substance Use Disorders | Medical Problem Interferes with Protocol Compliance | Medical Problem Limiting Life Expectancy
Item
cancer, substance abuse, or any health problem that may interfere with the compliance to the study protocol or limit life expectancy
boolean
C0006826 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C1254481 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C1254481 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0023671 (UMLS CUI [4,3])
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