ID

43704

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00730067

Trefwoorden

  1. 28-02-16 28-02-16 -
  2. 20-09-21 20-09-21 -
Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility COPD NCT00730067

Eligibility COPD NCT00730067

  1. StudyEvent: Eligibility
    1. Eligibility COPD NCT00730067
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

mean pulmonary arterial pressure; right heart catheterization

Datatype

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.
Beschrijving

pulmonary hypertension Association Chronic Obstructive Airway Disease

Datatype

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.
Beschrijving

copd; Adrenergic beta-Antagonists; exacerbation

Datatype

boolean

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

age

Datatype

boolean

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

informed consent

Datatype

boolean

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

Contraception status

Datatype

boolean

Alias
UMLS CUI [1]
C0420837
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
rheumatic disease limiting walking capacity.
Beschrijving

rheumatic disease; Ability to walk limited

Datatype

boolean

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

exacerbation copd

Datatype

boolean

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

age

Datatype

boolean

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

fev1

Datatype

boolean

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

hypersensitivity sildenafil

Datatype

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.
Beschrijving

blood pressure

Datatype

boolean

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

medication dose; peripheral saturation

Datatype

boolean

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

treatment nitrous vasodilators

Datatype

boolean

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

Similar models

Eligibility COPD NCT00730067

  1. StudyEvent: Eligibility
    1. Eligibility COPD NCT00730067
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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