ID

43704

Description

Sildenafil for Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00730067

Link

https://clinicaltrials.gov/show/NCT00730067

Keywords

Versions (2)
  1. 2/28/16 2/28/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility COPD NCT00730067

English

Eligibility COPD NCT00730067

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility COPD NCT00730067
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
a mean pulmonary arterial pressure of 25 mmhg measured by right heart catheterization.
Description

mean pulmonary arterial pressure; right heart catheterization

Data type

boolean

Alias
UMLS CUI [1]
C3854605
UMLS CUI [2]
C0189896
a diagnosis of copd-associated pulmonary hypertension, implicating that no other potential cause of pulmonary hypertension is present.
Description

pulmonary hypertension Association Chronic Obstructive Airway Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C1511978
UMLS CUI [1,3]
C0024117
stable copd, defined by no subjective alterations of symptoms or use of short acting beta-antagonists for minimally six weeks. any exacerbation resulting in admission to hospital or other contacts to a physician must have ceased for at least 6 weeks before entering the study.
Description

copd; Adrenergic beta-Antagonists; exacerbation

Data type

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0001645
UMLS CUI [3]
C0235874
age > 18
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
informed written consent.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
reliable anticonception for fertile women.
Description

Contraception status

Data type

boolean

Alias
UMLS CUI [1]
C0420837
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
rheumatic disease limiting walking capacity.
Description

rheumatic disease; Ability to walk limited

Data type

boolean

Alias
UMLS CUI [1]
C0035435
UMLS CUI [2,1]
C0559964
UMLS CUI [2,2]
C0439801
exacerbation in copd during the study.
Description

exacerbation copd

Data type

boolean

Alias
UMLS CUI [1,1]
C0235874
UMLS CUI [1,2]
C0024117
age>80 years
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
fev1 < 25 % of predicted.
Description

fev1

Data type

boolean

Alias
UMLS CUI [1]
C3815113
allergy towards contents of sildenafil or placebo tablets.
Description

hypersensitivity sildenafil

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0529793
fall in blood pressure of > 30 mmhg systolic or >20 mmhg diastolic after intake of the first dose of trial medication.
Description

blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0005823
fall in peripheral saturation of > 5% after intake of the first dose of trial medication.
Description

medication dose; peripheral saturation

Data type

boolean

Alias
UMLS CUI [1]
C3174092
UMLS CUI [2]
C2317096
treatment with nitrous vasodilators or aminophyllamines.
Description

treatment nitrous vasodilators

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0360716
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Similar models

Eligibility COPD NCT00730067

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility COPD NCT00730067
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
mean pulmonary arterial pressure; right heart catheterization
Item
a mean pulmonary arterial pressure of 25 mmhg measured by right heart catheterization.
boolean
C3854605 (UMLS CUI [1])
C0189896 (UMLS CUI [2])
pulmonary hypertension Association Chronic Obstructive Airway Disease
Item
a diagnosis of copd-associated pulmonary hypertension, implicating that no other potential cause of pulmonary hypertension is present.
boolean
C0020542 (UMLS CUI [1,1])
C1511978 (UMLS CUI [1,2])
C0024117 (UMLS CUI [1,3])
copd; Adrenergic beta-Antagonists; exacerbation
Item
stable copd, defined by no subjective alterations of symptoms or use of short acting beta-antagonists for minimally six weeks. any exacerbation resulting in admission to hospital or other contacts to a physician must have ceased for at least 6 weeks before entering the study.
boolean
C0024117 (UMLS CUI [1])
C0001645 (UMLS CUI [2])
C0235874 (UMLS CUI [3])
age
Item
age > 18
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
informed written consent.
boolean
C0021430 (UMLS CUI [1])
Contraception status
Item
reliable anticonception for fertile women.
boolean
C0420837 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
rheumatic disease; Ability to walk limited
Item
rheumatic disease limiting walking capacity.
boolean
C0035435 (UMLS CUI [1])
C0559964 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
exacerbation copd
Item
exacerbation in copd during the study.
boolean
C0235874 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
age
Item
age>80 years
boolean
C0001779 (UMLS CUI [1])
fev1
Item
fev1 < 25 % of predicted.
boolean
C3815113 (UMLS CUI [1])
hypersensitivity sildenafil
Item
allergy towards contents of sildenafil or placebo tablets.
boolean
C0020517 (UMLS CUI [1,1])
C0529793 (UMLS CUI [1,2])
blood pressure
Item
fall in blood pressure of > 30 mmhg systolic or >20 mmhg diastolic after intake of the first dose of trial medication.
boolean
C0005823 (UMLS CUI [1])
medication dose; peripheral saturation
Item
fall in peripheral saturation of > 5% after intake of the first dose of trial medication.
boolean
C3174092 (UMLS CUI [1])
C2317096 (UMLS CUI [2])
treatment nitrous vasodilators
Item
treatment with nitrous vasodilators or aminophyllamines.
boolean
C0087111 (UMLS CUI [1,1])
C0360716 (UMLS CUI [1,2])
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