Informações:
Falhas:
ID
36153
Descrição
Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 Inhibitor; ODM derived from: https://clinicaltrials.gov/show/NCT02007629
Link
https://clinicaltrials.gov/show/NCT02007629
Palavras-chave
Versões (1)
- 18/04/2019 18/04/2019 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
18 de abril de 2019
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Hypertension, Pulmonary NCT02007629
Eligibility Hypertension, Pulmonary NCT02007629
- StudyEvent: Eligibility
Similar models
Eligibility Hypertension, Pulmonary NCT02007629
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age | Idiopathic pulmonary hypertension | Familial primary pulmonary hypertension | Pulmonary arterial hypertension induced by drug | Pulmonary arterial hypertension induced by toxin | Etiology Congenital heart disease | Classification Specified Pulmonary Hypertension
Item
male or female patients (18 -75 years of age) with idiopathic, familial, drug/toxin induced and associated pah due to congenital heart disease (group i / dana point classification of ph) demonstrating insufficient response to treatment with pde-5i for at least 3 months
boolean
C0001779 (UMLS CUI [1])
C0152171 (UMLS CUI [2])
C0340543 (UMLS CUI [3])
C0340544 (UMLS CUI [4])
C3697954 (UMLS CUI [5])
C0015127 (UMLS CUI [6,1])
C0152021 (UMLS CUI [6,2])
C0008902 (UMLS CUI [7,1])
C0205369 (UMLS CUI [7,2])
C0020542 (UMLS CUI [7,3])
C0152171 (UMLS CUI [2])
C0340543 (UMLS CUI [3])
C0340544 (UMLS CUI [4])
C3697954 (UMLS CUI [5])
C0015127 (UMLS CUI [6,1])
C0152021 (UMLS CUI [6,2])
C0008902 (UMLS CUI [7,1])
C0205369 (UMLS CUI [7,2])
C0020542 (UMLS CUI [7,3])
Endothelin receptor antagonist | Endothelin receptor antagonist Absent
Item
patients with and without endothelin receptor antagonist (era) therapy
boolean
C1134681 (UMLS CUI [1])
C1134681 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1134681 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
WHO classification Pulmonary arterial hypertension
Item
world health organization functional class (who fc) iii at screening
boolean
C4267671 (UMLS CUI [1,1])
C2973725 (UMLS CUI [1,2])
C2973725 (UMLS CUI [1,2])
6-Minute Walk Test Walking distance
Item
6-minute walking distance (6mwd) of 165-440 m
boolean
C0430515 (UMLS CUI [1,1])
C0429886 (UMLS CUI [1,2])
C0429886 (UMLS CUI [1,2])
Cardiac index
Item
cardiac index <3.0 l/min/m2.
boolean
C0428776 (UMLS CUI [1])
Pulmonary Hypertension Type All | Exception Subtype Specified
Item
all types of ph except subtypes of dana point group i specified in the inclusion criteria
boolean
C0020542 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0444868 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0449560 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
C0332307 (UMLS CUI [1,2])
C0444868 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0449560 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Restrictive lung disease Parenchymal | Obstructive Lung Diseases Parenchymal
Item
evidence of clinically significant restrictive or obstructive parenchymal lung diseases
boolean
C0085581 (UMLS CUI [1,1])
C4277702 (UMLS CUI [1,2])
C0600260 (UMLS CUI [2,1])
C4277702 (UMLS CUI [2,2])
C4277702 (UMLS CUI [1,2])
C0600260 (UMLS CUI [2,1])
C4277702 (UMLS CUI [2,2])
Percent Predicted Diffusion Capacity of the Lung for Carbon Monoxide
Item
diffusing capacity of the lung for carbon monoxide (dlco) <30% predicted
boolean
C4054207 (UMLS CUI [1])
Hemoptysis Serious | Pulmonary hemorrhage Serious | Embolization of bronchial artery
Item
history or active state of serious hemoptysis / pulmonary hemorrhage including those managed by bronchial artery embolization
boolean
C0019079 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0151701 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0472640 (UMLS CUI [3])
C0205404 (UMLS CUI [1,2])
C0151701 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0472640 (UMLS CUI [3])
6-Minute Walk Test Unable
Item
patients unable to perform a valid 6mwd test
boolean
C0430515 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,2])
Pregnancy | Pregnancy test positive | Breast Feeding | Childbearing Potential Contraceptive methods Quantity Absent | Female Condoms | Contraceptives, Oral | Contraceptive injection | Contraceptive patch | Intrauterine Devices | Barrier Contraception Double
Item
pregnant women (i.e. positive pregnancy test or other signs of pregnancy), or breast feeding women, or women with childbearing potential not using a combination of 2 effective methods of birth control, for example a combination of condoms with a safe and highly effective contraception method (prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device) or a double barrier method is used throughout the study
boolean
C0032961 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0332197 (UMLS CUI [4,4])
C0221829 (UMLS CUI [5])
C0009905 (UMLS CUI [6])
C1656586 (UMLS CUI [7])
C2985284 (UMLS CUI [8])
C0021900 (UMLS CUI [9])
C0004764 (UMLS CUI [10,1])
C0205173 (UMLS CUI [10,2])
C0240802 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0332197 (UMLS CUI [4,4])
C0221829 (UMLS CUI [5])
C0009905 (UMLS CUI [6])
C1656586 (UMLS CUI [7])
C2985284 (UMLS CUI [8])
C0021900 (UMLS CUI [9])
C0004764 (UMLS CUI [10,1])
C0205173 (UMLS CUI [10,2])