ID

18104

Description

A 16 Week Study to Evaluate the Effect on Insulin Sensitivity of Valsartan (320 mg) and Hydrochlorothiazide (25 mg) Combined and Alone, in Patients With Metabolic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT00170937

Link

https://clinicaltrials.gov/show/NCT00170937

Keywords

  1. 10/19/16 10/19/16 -
Uploaded on

October 19, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Metabolic Syndrome NCT00170937

Eligibility Metabolic Syndrome NCT00170937

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
waist circumference: males > 40", females > 35 "
Description

Waist Circumference | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0455829
UMLS CUI [2]
C0079399
mssbp ≥ 130 mmhg but ≤ 160 mmhg and a msdbp ≥ 85 mmhg but ≤ 100 mmhg
Description

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
at least one of the following criteria: - fasting plasma glucose between 5.9 and 6.9 mmol/l; - serum triglycerides > 150 mg/dl; - ldl cholesterol: - < 40 mg/dl males; - < 50 mg/dl females
Description

Plasma fasting glucose measurement | Serum Triglyceride Measurement | Low density lipoprotein cholesterol measurement | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0583513
UMLS CUI [2]
C0542495
UMLS CUI [3]
C0202117
UMLS CUI [4]
C0079399
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
mssbp> 180 mmhg or msdbp > 110 mmhg
Description

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
inability to discontinue all prior antihypertensives for a period of 4 weeks.
Description

Antihypertensive Agents Discontinue Time period Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1948053
UMLS CUI [1,4]
C1299582
history of diabetes
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
history of stroke, transient ischemic attack or myocardial infarction.
Description

Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
UMLS CUI [3]
C0027051
significant weight change > 10 lbs during screening period
Description

Weight Change Significant Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0005911
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C1265611
patients taking a diuretic for 3 months prior to screening.
Description

Diuretic

Data type

boolean

Alias
UMLS CUI [1]
C0012798
other protocol-defined exclusion criteria may apply.
Description

Exclusion Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348563

Similar models

Eligibility Metabolic Syndrome NCT00170937

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Waist Circumference | Gender
Item
waist circumference: males > 40", females > 35 "
boolean
C0455829 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
mssbp ≥ 130 mmhg but ≤ 160 mmhg and a msdbp ≥ 85 mmhg but ≤ 100 mmhg
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Plasma fasting glucose measurement | Serum Triglyceride Measurement | Low density lipoprotein cholesterol measurement | Gender
Item
at least one of the following criteria: - fasting plasma glucose between 5.9 and 6.9 mmol/l; - serum triglycerides > 150 mg/dl; - ldl cholesterol: - < 40 mg/dl males; - < 50 mg/dl females
boolean
C0583513 (UMLS CUI [1])
C0542495 (UMLS CUI [2])
C0202117 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
mssbp> 180 mmhg or msdbp > 110 mmhg
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Antihypertensive Agents Discontinue Time period Unable
Item
inability to discontinue all prior antihypertensives for a period of 4 weeks.
boolean
C0003364 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1948053 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Diabetes Mellitus
Item
history of diabetes
boolean
C0011849 (UMLS CUI [1])
Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction
Item
history of stroke, transient ischemic attack or myocardial infarction.
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
Weight Change Significant Quantity
Item
significant weight change > 10 lbs during screening period
boolean
C0005911 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Diuretic
Item
patients taking a diuretic for 3 months prior to screening.
boolean
C0012798 (UMLS CUI [1])
Exclusion Criteria Study Protocol
Item
other protocol-defined exclusion criteria may apply.
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])

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