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Information:
Fel:
ID
13716
Beskrivning
Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study; ODM derived from: https://clinicaltrials.gov/show/NCT01469169
Länk
https://clinicaltrials.gov/show/NCT01469169
Nyckelord
Versioner (2)
- 2016-02-29 2016-02-29 -
- 2021-09-20 2021-09-20 -
Uppladdad den
29 februari 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Hypertension, Pulmonary NCT01469169
Eligibility Hypertension, Pulmonary NCT01469169
- StudyEvent: Eligibility
Similar models
Eligibility Hypertension, Pulmonary NCT01469169
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
gender; age
Item
male or female subjects aged 18 to 75 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
Pulmonary Hypertension
Item
symptomatic pulmonary artery hypertension (pah) classified (dana point classification 1)
boolean
C0020542 (UMLS CUI [1])
new york heart association classification
Item
new york heart association (nyha)/world health organization (who) functional class iii or iv
boolean
C1275491 (UMLS CUI [1])
Pulmonary artery mean pressure; pulmonary capillary wedge pressure; pulmonary vascular resistance
Item
papmean at rest > 25 mm hg, pulmonary capillary wedge pressure (pcwp) or left ventricular end-diastolic pressure </= 15 mm hg and pulmonary vascular resistance (pvr) >/= 240 dyn･sec･cm-5 (>/= 400 dyn・sec・cm-5 for patients treated with both endothelin receptor antagonist (era) and phosphodiesterase-5 inhibitor (pde5i) ) as measured by right heart catheter test
boolean
C0428645 (UMLS CUI [1])
C0086879 (UMLS CUI [2])
C0456261 (UMLS CUI [3])
C0086879 (UMLS CUI [2])
C0456261 (UMLS CUI [3])
contraception
Item
women of childbearing potential and men must agree to use adequate contraception when sexually active
boolean
C0700589 (UMLS CUI [1])
Walk distance 6M
Item
baseline 6-minute walk distance of less than 100 meters or more than 500 meters
boolean
C3854161 (UMLS CUI [1])
pulmonary hypertension
Item
subjects with critical severe pah
boolean
C0020542 (UMLS CUI [1])
fev1; total lung capacity; interstitial lung disease
Item
forced expiratory volume in 1 second (fev1)/forced vital capacity (fvc) ratio < 60% and/or total lung capacity (tlc) < 70% predicted (especially at interstitial lung disease, tlc < 60% predicted)
boolean
C2238302 (UMLS CUI [1])
C0040509 (UMLS CUI [2])
C0206062 (UMLS CUI [3])
C0040509 (UMLS CUI [2])
C0206062 (UMLS CUI [3])
obstructive lung disease; asthma
Item
clinically relevant obstructive lung disease (e.g. asthma or chronic obstructive pulmonary disease )
boolean
C0600260 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C0004096 (UMLS CUI [2])
High resolution CT of lungs; interstitial lung disease
Item
more than mild patchy interstitial lung disease on high resolution computerized tomography (hrct)
boolean
C0412612 (UMLS CUI [1])
C0206062 (UMLS CUI [2])
C0206062 (UMLS CUI [2])
Heart Diseases Left sided
Item
history of left-sided heart disease
boolean
C0018799 (UMLS CUI [1,1])
C0443246 (UMLS CUI [1,2])
C0443246 (UMLS CUI [1,2])
Hypertensive disease; blood pressure
Item
uncontrolled systemic hypertension as evidenced by systolic blood pressure >/= 160 mm hg or diastolic blood pressure >/= 100 mm hg on repeated measurement
boolean
C0020538 (UMLS CUI [1])
C0005823 (UMLS CUI [2])
C0005823 (UMLS CUI [2])
Hypotension; systolic blood pressure
Item
systemic hypotension with systolic blood pressure < 85 mm hg
boolean
C0020649 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0871470 (UMLS CUI [2])