ID

36153

Beschrijving

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

Trefwoorden

Versies (1)
  1. 18-04-19 18-04-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

18 april 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Hypertension, Pulmonary NCT02007629

Engels

Eligibility Hypertension, Pulmonary NCT02007629

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
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
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0152171
UMLS CUI [3]
C0340543
UMLS CUI [4]
C0340544
UMLS CUI [5]
C3697954
UMLS CUI [6,1]
C0015127
UMLS CUI [6,2]
C0152021
UMLS CUI [7,1]
C0008902
UMLS CUI [7,2]
C0205369
UMLS CUI [7,3]
C0020542
patients with and without endothelin receptor antagonist (era) therapy
Beschrijving

Endothelin receptor antagonist | Endothelin receptor antagonist Absent

Datatype

boolean

Alias
UMLS CUI [1]
C1134681
UMLS CUI [2,1]
C1134681
UMLS CUI [2,2]
C0332197
world health organization functional class (who fc) iii at screening
Beschrijving

WHO classification Pulmonary arterial hypertension

Datatype

boolean

Alias
UMLS CUI [1,1]
C4267671
UMLS CUI [1,2]
C2973725
6-minute walking distance (6mwd) of 165-440 m
Beschrijving

6-Minute Walk Test Walking distance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0430515
UMLS CUI [1,2]
C0429886
cardiac index <3.0 l/min/m2.
Beschrijving

Cardiac index

Datatype

boolean

Alias
UMLS CUI [1]
C0428776
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
all types of ph except subtypes of dana point group i specified in the inclusion criteria
Beschrijving

Pulmonary Hypertension Type All | Exception Subtype Specified

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0444868
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0449560
UMLS CUI [2,3]
C0205369
evidence of clinically significant restrictive or obstructive parenchymal lung diseases
Beschrijving

Restrictive lung disease Parenchymal | Obstructive Lung Diseases Parenchymal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085581
UMLS CUI [1,2]
C4277702
UMLS CUI [2,1]
C0600260
UMLS CUI [2,2]
C4277702
diffusing capacity of the lung for carbon monoxide (dlco) <30% predicted
Beschrijving

Percent Predicted Diffusion Capacity of the Lung for Carbon Monoxide

Datatype

boolean

Alias
UMLS CUI [1]
C4054207
history or active state of serious hemoptysis / pulmonary hemorrhage including those managed by bronchial artery embolization
Beschrijving

Hemoptysis Serious | Pulmonary hemorrhage Serious | Embolization of bronchial artery

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019079
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0151701
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0472640
patients unable to perform a valid 6mwd test
Beschrijving

6-Minute Walk Test Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0430515
UMLS CUI [1,2]
C1299582
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
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0240802
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C1265611
UMLS CUI [4,4]
C0332197
UMLS CUI [5]
C0221829
UMLS CUI [6]
C0009905
UMLS CUI [7]
C1656586
UMLS CUI [8]
C2985284
UMLS CUI [9]
C0021900
UMLS CUI [10,1]
C0004764
UMLS CUI [10,2]
C0205173
Terug naar het begin van de pagina

Similar models

Eligibility Hypertension, Pulmonary NCT02007629

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
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])
Cardiac index
Item
cardiac index <3.0 l/min/m2.
boolean
C0428776 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial