ID

40374

Description

The Study of Apelin-APJ System on Pulmonary Hypertension Patients and Healthy Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT01590108

Link

https://clinicaltrials.gov/show/NCT01590108

Keywords

Versions (1)
  1. 4/15/20 4/15/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 15, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Idiopathic Pulmonary Arterial Hypertension NCT01590108

English

Eligibility Idiopathic Pulmonary Arterial Hypertension NCT01590108

1 forms  
Criteria
Description

Criteria

structurally normal heart by 2d echocardiography
Description

Heart structural normal | 2D Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0018787
UMLS CUI [1,2]
C0678594
UMLS CUI [1,3]
C0205307
UMLS CUI [2]
C0013524
pulmonary artery pressure < 25mmhg
Description

Pulmonary artery pressure

Data type

boolean

Alias
UMLS CUI [1]
C0428642
tricuspid velocity < 2.5ms-1
Description

Tricuspid Valve Regurgitation Velocity

Data type

boolean

Alias
UMLS CUI [1]
C4527152
inclusion criteria for treatment group:
Description

Inclusion criteria | Treatment Group

Data type

boolean

Alias
UMLS CUI [1]
C1512693
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0441833
clinical diagnosis of pulmonary arterial hypertension that is idiopathic, associated with anorexigens associated with connective tissue disease or familial
Description

Idiopathic pulmonary arterial hypertension | Appetite Depressants | Connective Tissue Diseases

Data type

boolean

Alias
UMLS CUI [1]
C3203102
UMLS CUI [2]
C0003620
UMLS CUI [3]
C0009782
able to give informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
mean pulmonary artery pressure > 25mmhg, pulmonary capillary wedge pressure < 15mmhg, with normal or reduced cardiac output.
Description

Mean pulmonary arterial pressure | Pulmonary Capillary Wedge Pressure | Cardiac Output Normal | Cardiac Output Reduced

Data type

boolean

Alias
UMLS CUI [1]
C3854605
UMLS CUI [2]
C0086879
UMLS CUI [3,1]
C0007165
UMLS CUI [3,2]
C0205307
UMLS CUI [4,1]
C0007165
UMLS CUI [4,2]
C0392756
exclusion criteria for all group:
Description

Exclusion Criteria | Groups All

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0441833
UMLS CUI [2,2]
C0444868
bleeding diathesis (pt > 14 sec to aptt > 40 sec)
Description

Bleeding tendency | Prothrombin time assay | Activated Partial Thromboplastin Time measurement

Data type

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0033707
UMLS CUI [3]
C0030605
pregnancy, or women of child bearing potential not on adequate contraception
Description

Pregnancy | Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
renal or hepatic failure
Description

Kidney Failure | Liver Failure

Data type

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0085605
severe valvular heart disease
Description

Heart valve disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0205082
left ventricular dysfunction (lvef < 40)
Description

Ventricular Dysfunction, Left | Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0242698
UMLS CUI [2]
C0428772
chronic lung disease
Description

Chronic lung disease

Data type

boolean

Alias
UMLS CUI [1]
C0746102
malignant arrhythmias
Description

Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0003811
chronic thromboembolic disease
Description

Thromboembolism chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0040038
UMLS CUI [1,2]
C0205191
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Similar models

Eligibility Idiopathic Pulmonary Arterial Hypertension NCT01590108

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Heart structural normal | 2D Echocardiography
Item
structurally normal heart by 2d echocardiography
boolean
C0018787 (UMLS CUI [1,1])
C0678594 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
C0013524 (UMLS CUI [2])
Pulmonary artery pressure
Item
pulmonary artery pressure < 25mmhg
boolean
C0428642 (UMLS CUI [1])
Tricuspid Valve Regurgitation Velocity
Item
tricuspid velocity < 2.5ms-1
boolean
C4527152 (UMLS CUI [1])
Inclusion criteria | Treatment Group
Item
inclusion criteria for treatment group:
boolean
C1512693 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0441833 (UMLS CUI [2,2])
Idiopathic pulmonary arterial hypertension | Appetite Depressants | Connective Tissue Diseases
Item
clinical diagnosis of pulmonary arterial hypertension that is idiopathic, associated with anorexigens associated with connective tissue disease or familial
boolean
C3203102 (UMLS CUI [1])
C0003620 (UMLS CUI [2])
C0009782 (UMLS CUI [3])
Informed Consent
Item
able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Mean pulmonary arterial pressure | Pulmonary Capillary Wedge Pressure | Cardiac Output Normal | Cardiac Output Reduced
Item
mean pulmonary artery pressure > 25mmhg, pulmonary capillary wedge pressure < 15mmhg, with normal or reduced cardiac output.
boolean
C3854605 (UMLS CUI [1])
C0086879 (UMLS CUI [2])
C0007165 (UMLS CUI [3,1])
C0205307 (UMLS CUI [3,2])
C0007165 (UMLS CUI [4,1])
C0392756 (UMLS CUI [4,2])
Exclusion Criteria | Groups All
Item
exclusion criteria for all group:
boolean
C0680251 (UMLS CUI [1])
C0441833 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
Bleeding tendency | Prothrombin time assay | Activated Partial Thromboplastin Time measurement
Item
bleeding diathesis (pt > 14 sec to aptt > 40 sec)
boolean
C1458140 (UMLS CUI [1])
C0033707 (UMLS CUI [2])
C0030605 (UMLS CUI [3])
Pregnancy | Childbearing Potential Contraceptive methods Absent
Item
pregnancy, or women of child bearing potential not on adequate contraception
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Kidney Failure | Liver Failure
Item
renal or hepatic failure
boolean
C0035078 (UMLS CUI [1])
C0085605 (UMLS CUI [2])
Heart valve disease Severe
Item
severe valvular heart disease
boolean
C0018824 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Ventricular Dysfunction, Left | Left ventricular ejection fraction
Item
left ventricular dysfunction (lvef < 40)
boolean
C0242698 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Chronic lung disease
Item
chronic lung disease
boolean
C0746102 (UMLS CUI [1])
Cardiac Arrhythmia
Item
malignant arrhythmias
boolean
C0003811 (UMLS CUI [1])
Thromboembolism chronic
Item
chronic thromboembolic disease
boolean
C0040038 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
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