ID

40314

Description

Galectin-3 Blockade in Patients With High Blood Pressure; ODM derived from: https://clinicaltrials.gov/show/NCT01960946

Link

https://clinicaltrials.gov/show/NCT01960946

Keywords

Versions (1)
  1. 4/6/20 4/6/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 6, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01960946

English

Eligibility Hypertension NCT01960946

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 21-70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
physician diagnosed hypertension on stable therapy for 3 months
Description

Hypertensive disease | Therapeutic procedure Stable

Data type

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205360
elevated galectin-3 level (above sex-specific median based on framingham heart study measures)
Description

Galectin-3 increased

Data type

boolean

Alias
UMLS CUI [1]
C4049292
able to understand the protocol and provide informed consent in english
Description

Comprehension Study Protocol English Language | Informed Consent English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0376245
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0376245
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled hypertension, defined as systolic blood pressure > 170mmhg, diastolic blood pressure > 100mmhg
Description

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
evidence of secondary hypertension
Description

Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0155616
history of heart failure, coronary artery disease, stroke, atrial fibrillation
Description

Heart failure | Coronary Artery Disease | Cerebrovascular accident | Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C1956346
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0004238
left ventricular ejection fraction < 45% on echocardiography
Description

Left ventricular ejection fraction Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
use of aldosterone antagonists
Description

Aldosterone Antagonists

Data type

boolean

Alias
UMLS CUI [1]
C0002007
history of liver cirrhosis
Description

Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023890
history of pulmonary fibrosis
Description

Pulmonary Fibrosis

Data type

boolean

Alias
UMLS CUI [1]
C0034069
kidney dysfunction, defined as estimated glomerular filtration rate < 45 ml/min/1.73m2
Description

Abnormal renal function | Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C0151746
UMLS CUI [2]
C3811844
anemia, defined as hematocrit < 38% in men and < 36% in women
Description

Anemia | Hematocrit procedure | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0018935
UMLS CUI [3]
C0079399
use of chelating agents
Description

Chelating Agents

Data type

boolean

Alias
UMLS CUI [1]
C0007974
history of cancer or malignancy
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
known pregnancy, those unwilling to avoid pregnancy during the course of the study, or women currently breastfeeding
Description

Pregnancy | Gender Contraceptive methods Unwilling | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
UMLS CUI [3]
C0006147
hyperkalemia on screening labs, defined as potassium >5.0
Description

Hyperkalemia | Potassium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0020461
UMLS CUI [2]
C0202194
anticipated inability to complete or comply with study protocol
Description

Completion of clinical trial Unable | Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C2732579
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
history of angioedema
Description

Angioedema

Data type

boolean

Alias
UMLS CUI [1]
C0002994
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Similar models

Eligibility Hypertension NCT01960946

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 21-70 years
boolean
C0001779 (UMLS CUI [1])
Hypertensive disease | Therapeutic procedure Stable
Item
physician diagnosed hypertension on stable therapy for 3 months
boolean
C0020538 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Galectin-3 increased
Item
elevated galectin-3 level (above sex-specific median based on framingham heart study measures)
boolean
C4049292 (UMLS CUI [1])
Comprehension Study Protocol English Language | Informed Consent English Language
Item
able to understand the protocol and provide informed consent in english
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled hypertension, defined as systolic blood pressure > 170mmhg, diastolic blood pressure > 100mmhg
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Secondary hypertension
Item
evidence of secondary hypertension
boolean
C0155616 (UMLS CUI [1])
Heart failure | Coronary Artery Disease | Cerebrovascular accident | Atrial Fibrillation
Item
history of heart failure, coronary artery disease, stroke, atrial fibrillation
boolean
C0018801 (UMLS CUI [1])
C1956346 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0004238 (UMLS CUI [4])
Left ventricular ejection fraction Echocardiography
Item
left ventricular ejection fraction < 45% on echocardiography
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Aldosterone Antagonists
Item
use of aldosterone antagonists
boolean
C0002007 (UMLS CUI [1])
Liver Cirrhosis
Item
history of liver cirrhosis
boolean
C0023890 (UMLS CUI [1])
Pulmonary Fibrosis
Item
history of pulmonary fibrosis
boolean
C0034069 (UMLS CUI [1])
Abnormal renal function | Estimated Glomerular Filtration Rate
Item
kidney dysfunction, defined as estimated glomerular filtration rate < 45 ml/min/1.73m2
boolean
C0151746 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
Anemia | Hematocrit procedure | Gender
Item
anemia, defined as hematocrit < 38% in men and < 36% in women
boolean
C0002871 (UMLS CUI [1])
C0018935 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Chelating Agents
Item
use of chelating agents
boolean
C0007974 (UMLS CUI [1])
Malignant Neoplasms
Item
history of cancer or malignancy
boolean
C0006826 (UMLS CUI [1])
Pregnancy | Gender Contraceptive methods Unwilling | Breast Feeding
Item
known pregnancy, those unwilling to avoid pregnancy during the course of the study, or women currently breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0006147 (UMLS CUI [3])
Hyperkalemia | Potassium measurement
Item
hyperkalemia on screening labs, defined as potassium >5.0
boolean
C0020461 (UMLS CUI [1])
C0202194 (UMLS CUI [2])
Completion of clinical trial Unable | Protocol Compliance Unable
Item
anticipated inability to complete or comply with study protocol
boolean
C2732579 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Angioedema
Item
history of angioedema
boolean
C0002994 (UMLS CUI [1])
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