ID

25563

Description

Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics; ODM derived from: https://clinicaltrials.gov/show/NCT00486291

Link

https://clinicaltrials.gov/show/NCT00486291

Keywords

Versions (1)
  1. 9/5/17 9/5/17 -
Uploaded on

September 5, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00486291

English

Eligibility Type 2 Diabetes Mellitus NCT00486291

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
bmi 27-42
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
specified diet/exercise and/or diabetes medications
Description

Diet specified | Exercise specified | Antidiabetics

Data type

boolean

Alias
UMLS CUI [1,1]
C0012155
UMLS CUI [1,2]
C0205369
UMLS CUI [2,1]
C0015259
UMLS CUI [2,2]
C0205369
UMLS CUI [3]
C0935929
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
bp > 150/95
Description

Increase in blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0497247
stroke/mi/unstable cardiovascular disease within 6 months
Description

Cerebrovascular accident | Myocardial Infarction | Cardiovascular Disease Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0007222
UMLS CUI [3,2]
C0443343
clinically significant renal, hepatic, or psychiatric disease
Description

Kidney Disease | Liver disease | Mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0004936
unstable thyroid disease or replacement therapy
Description

Thyroid Disease Unstable | Thyroid hormone replacement therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C2242640
nephrolithiasis
Description

Nephrolithiasis

Data type

boolean

Alias
UMLS CUI [1]
C0392525
obesity of known genetic or endocrine origin
Description

Obesity origin genetic | Obesity of endocrine origin

Data type

boolean

Alias
UMLS CUI [1,1]
C0028754
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0314603
UMLS CUI [2]
C0267992
participation in a formal weight loss program or lifestyle intervention
Description

Participation Weight Reduction Program | Life Style Intervention

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C3179079
UMLS CUI [2,1]
C0023676
UMLS CUI [2,2]
C0184661
history of glaucoma
Description

Glaucoma

Data type

boolean

Alias
UMLS CUI [1]
C0017601
pregnancy or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
alcohol abuse
Description

Alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0085762
eating disorder
Description

Eating Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0013473
excluded medications
Description

Pharmaceutical Preparations Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2828389
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00486291

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Body mass index
Item
bmi 27-42
boolean
C1305855 (UMLS CUI [1])
Diet specified | Exercise specified | Antidiabetics
Item
specified diet/exercise and/or diabetes medications
boolean
C0012155 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0015259 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C0935929 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Increase in blood pressure
Item
bp > 150/95
boolean
C0497247 (UMLS CUI [1])
Cerebrovascular accident | Myocardial Infarction | Cardiovascular Disease Unstable
Item
stroke/mi/unstable cardiovascular disease within 6 months
boolean
C0038454 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0007222 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
Kidney Disease | Liver disease | Mental disorders
Item
clinically significant renal, hepatic, or psychiatric disease
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
Thyroid Disease Unstable | Thyroid hormone replacement therapy
Item
unstable thyroid disease or replacement therapy
boolean
C0040128 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C2242640 (UMLS CUI [2])
Nephrolithiasis
Item
nephrolithiasis
boolean
C0392525 (UMLS CUI [1])
Obesity origin genetic | Obesity of endocrine origin
Item
obesity of known genetic or endocrine origin
boolean
C0028754 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0314603 (UMLS CUI [1,3])
C0267992 (UMLS CUI [2])
Participation Weight Reduction Program | Life Style Intervention
Item
participation in a formal weight loss program or lifestyle intervention
boolean
C0679823 (UMLS CUI [1,1])
C3179079 (UMLS CUI [1,2])
C0023676 (UMLS CUI [2,1])
C0184661 (UMLS CUI [2,2])
Glaucoma
Item
history of glaucoma
boolean
C0017601 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Alcohol abuse
Item
alcohol abuse
boolean
C0085762 (UMLS CUI [1])
Eating Disorders
Item
eating disorder
boolean
C0013473 (UMLS CUI [1])
Pharmaceutical Preparations Excluded
Item
excluded medications
boolean
C0013227 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
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