ID

32977

Description

Effects of Pioglitazone on High-density Lipoprotein (HDL) Function in Persons With Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01156597

Link

https://clinicaltrials.gov/show/NCT01156597

Keywords

Versions (1)
  1. 11/22/18 11/22/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 22, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT01156597

English

Eligibility Type 2 Diabetes Mellitus NCT01156597

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes, men and women, who criteria, aged 35-70 years
Description

Non-Insulin-Dependent Diabetes Mellitus WHO classification | Age

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C4267671
UMLS CUI [2]
C0001779
hba1c 7.5-10.0%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
bmi 26-39 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
either receiving dietary therapy only or monotherapy with either sulfonylurea or metformin
Description

Diet therapy | Sulfonylurea | Metformin

Data type

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2]
C0038766
UMLS CUI [3]
C0025598
already on statin therapy
Description

Patient is currently on a statin therapy

Data type

boolean

Alias
UMLS CUI [1]
C4316157
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
cardiovascular disease
Description

Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
renal disease
Description

Kidney Disease

Data type

boolean

Alias
UMLS CUI [1]
C0022658
other systemic disease
Description

Systemic disease

Data type

boolean

Alias
UMLS CUI [1]
C0442893
abnormal liver function tests (alt or ast>1.5 x uln)
Description

Liver function tests abnormal | Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151766
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
uncontrolled hypertension (bp >160/110)
Description

Uncontrolled hypertension | Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0005824
triglyceride levels >400 mg/dl
Description

Triglycerides measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202236
lipid modifying drugs; fibrates, ezetimibe, niacin, bile sequestrants, but not statins (see below),
Description

LIPID MODIFYING AGENTS | Fibrates | ezetimibe | Niacin | Bile acid sequestrants | Exception Statins

Data type

boolean

Alias
UMLS CUI [1]
C3653535
UMLS CUI [2]
C1449704
UMLS CUI [3]
C1142985
UMLS CUI [4]
C0027996
UMLS CUI [5]
C2917337
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0360714
estrogen treatment or thyroid disease
Description

Oestrogen therapy | Thyroid Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0279494
UMLS CUI [2]
C0040128
psychiatric condition or substance abuse
Description

Mental condition | Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C3840291
UMLS CUI [2]
C0038586
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT01156597

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus WHO classification | Age
Item
type 2 diabetes, men and women, who criteria, aged 35-70 years
boolean
C0011860 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
Hemoglobin A1c measurement
Item
hba1c 7.5-10.0%
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi 26-39 kg/m2
boolean
C1305855 (UMLS CUI [1])
Diet therapy | Sulfonylurea | Metformin
Item
either receiving dietary therapy only or monotherapy with either sulfonylurea or metformin
boolean
C0012159 (UMLS CUI [1])
C0038766 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
Patient is currently on a statin therapy
Item
already on statin therapy
boolean
C4316157 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cardiovascular Disease
Item
cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Kidney Disease
Item
renal disease
boolean
C0022658 (UMLS CUI [1])
Systemic disease
Item
other systemic disease
boolean
C0442893 (UMLS CUI [1])
Liver function tests abnormal | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
abnormal liver function tests (alt or ast>1.5 x uln)
boolean
C0151766 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Uncontrolled hypertension | Blood pressure determination
Item
uncontrolled hypertension (bp >160/110)
boolean
C1868885 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
Triglycerides measurement
Item
triglyceride levels >400 mg/dl
boolean
C0202236 (UMLS CUI [1])
LIPID MODIFYING AGENTS | Fibrates | ezetimibe | Niacin | Bile acid sequestrants | Exception Statins
Item
lipid modifying drugs; fibrates, ezetimibe, niacin, bile sequestrants, but not statins (see below),
boolean
C3653535 (UMLS CUI [1])
C1449704 (UMLS CUI [2])
C1142985 (UMLS CUI [3])
C0027996 (UMLS CUI [4])
C2917337 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0360714 (UMLS CUI [6,2])
Oestrogen therapy | Thyroid Diseases
Item
estrogen treatment or thyroid disease
boolean
C0279494 (UMLS CUI [1])
C0040128 (UMLS CUI [2])
Mental condition | Substance Use Disorders
Item
psychiatric condition or substance abuse
boolean
C3840291 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
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