Idiopathic pulmonary arterial hypertension | Familial pulmonary arterial hypertension
Item
idiopathic or familial pulmonary arterial hypertension (pah)
boolean
C3203102 (UMLS CUI [1])
C1701939 (UMLS CUI [2])
Pulmonary artery mean pressure | Pulmonary Capillary Wedge Pressure At rest
Item
mean pap at least 25 mm hg, pcwp < 15 mm hg at rest
boolean
C0428645 (UMLS CUI [1])
C0086879 (UMLS CUI [2,1])
C0443144 (UMLS CUI [2,2])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
for females of child-bearing potential negative pregnancy test at screening and use of contraception during the study and 4 weeks after its completion
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Informed Consent
Item
signed and dated informed consent
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
willingness to comply with the study plan and procedures
boolean
C0525058 (UMLS CUI [1])
Pulmonary arterial hypertension | Exception Idiopathic pulmonary arterial hypertension | Exception Familial pulmonary arterial hypertension
Item
pulmonary arterial hypertension (pah)other than idiopathic or familial
boolean
C2973725 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C3203102 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1701939 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
for females, pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Therapeutic procedure Specific Pulmonary arterial hypertension | CYP3A4 Inhibitors | Protease Inhibitors | Adrenergic alpha-Antagonists | Arginine
Item
use of specific pah treatments, potent cyp3a4 inhibitors, protease inhibitors, alpha blockers or arginine 30 days prior tio randomization and during the study
boolean
C0087111 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C2973725 (UMLS CUI [1,3])
C3850053 (UMLS CUI [2])
C0033607 (UMLS CUI [3])
C0001641 (UMLS CUI [4])
C0003765 (UMLS CUI [5])
Standard therapy Pulmonary arterial hypertension Dosage altered | Standard therapy Pulmonary arterial hypertension Class Changed | Oxygen | Calcium Channel Blockers | Digoxin | Diuretics
Item
change of dose or class of standard background pah therapy, i.e. oxygen, calcium channel blockers, digoxin, diuretics 30 days prior tio randomization and during the study
boolean
C2936643 (UMLS CUI [1,1])
C2973725 (UMLS CUI [1,2])
C0420247 (UMLS CUI [1,3])
C2936643 (UMLS CUI [2,1])
C2973725 (UMLS CUI [2,2])
C0456387 (UMLS CUI [2,3])
C0392747 (UMLS CUI [2,4])
C0030054 (UMLS CUI [3])
C0006684 (UMLS CUI [4])
C0012265 (UMLS CUI [5])
C0012798 (UMLS CUI [6])
Altitude Shift Large
Item
large shift in altitude (defined as >5000 feet or 1524 meters) during 90 days prior to baseline visit and/or during the study visit
boolean
C0002349 (UMLS CUI [1,1])
C2347509 (UMLS CUI [1,2])
C0549177 (UMLS CUI [1,3])
Cardiac shunt | Heart condition Serious | Lung Problem Serious | Other health conditions Serious
Item
subjects with intracardiac shunts and/or serious heart, lung or other health conditions
boolean
C0232180 (UMLS CUI [1])
C3842523 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0740941 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C2707304 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
HIV Seropositivity
Item
hiv positive subjects
boolean
C0019699 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
subjects participating in another clinical trial with an investigational drug or device
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Retinal Diseases degenerative | Nonarteritic anterior ischemic optic neuropathy | Proliferative diabetic retinopathy untreated
Item
subjects with degenerative retinal disorders, history of non-arteritic anterior ischemic optic neuropathy or untreated proliferative diabetic retinopathy
boolean
C0035309 (UMLS CUI [1,1])
C0011164 (UMLS CUI [1,2])
C1852242 (UMLS CUI [2])
C0154830 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
Hypersensitivity Phosphodiesterase 5 inhibitor | Intolerance to Phosphodiesterase 5 inhibitor
Item
allergies and previous intolerance of pde5 inhibitors
boolean
C0020517 (UMLS CUI [1,1])
C1318700 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C1318700 (UMLS CUI [2,2])
Substance Use Disorders
Item
alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Blood Donation
Item
blood donation during the study, or 1 month before or after the study
boolean
C0005794 (UMLS CUI [1])