ID

22266

Descripción

Safety and Efficacy of Inhaled Iloprost in Pediatric Patients With Pulmonary Arterial Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00453414

Link

https://clinicaltrials.gov/show/NCT00453414

Palabras clave

Versiones (1)
  1. 28/5/17 28/5/17 -
Subido en

28 de mayo de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Pulmonary Arterial Hypertension NCT00453414

Inglés

Eligibility Pulmonary Arterial Hypertension NCT00453414

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, age 3-18 years
Descripción

gender, age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
diagnosis of pah due to ipah, connective tissue disease, or congenital heart disease
Descripción

pulmonary arterial hypertension due to idiopathic pulmonary arterial hypertension, connective tissue disease or congenital heart disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C3203102
UMLS CUI [1,3]
C3697982
UMLS CUI [1,4]
C3698160
pulmonary arterial hypertension confirmed by a cardiac catheterization, with mpap > 25 mmhg at rest, pcwp or lvedp ≤ 15 mmhg, and pvr ≥ 240 dynes/sec/cm-5 (ie, ≥ 3.0 units m2)
Descripción

cardiac catheterization, mpap, pcwp, lvedp, pvr

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018795
UMLS CUI [1,2]
C3854605
UMLS CUI [1,3]
C0086879
UMLS CUI [1,4]
C0456190
UMLS CUI [1,5]
C0456261
nyha/who functional class ii, iii, or iv
Descripción

nyha

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1275491
have had a 6-minute walk test (6-mwt) performed within the 3 months preceding the screening visit (if ≥ 8 years of age)
Descripción

6-minute walk test

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0430515
have had cardiopulmonary exercise testing (cpet) performed within the 3 months preceding the screening visit (if ≥ 8 years of age and > 130 cms in height. cpet testing will be conducted on nyha/who class iv patients at the discretion of the principal investigator)
Descripción

cardiopulmonary exercise testing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2959886
if receiving therapy for pah, on a stable dose and regimen for at least 3 months prior to the screening visit
Descripción

pulmonary arterial hypertension therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0087111
if receiving digoxin, diuretic, or oxygen therapy, on a stable dose and regimen for at least 30 days preceding the screening visit
Descripción

digoxin, diuretic, oxygen therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0012798
UMLS CUI [2]
C0012265
UMLS CUI [3]
C0184633
must demonstrate the ability to appropriately use the nebulizer device as part of the screening process
Descripción

nebulizer use

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027524
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior use of prostacyclins or prostacyclin analogues within 3 months prior to screening
Descripción

prostacyclins

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205911
portal hypertension or clinically relevant hepatic disease
Descripción

portal hypertension, hepatic disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020541
UMLS CUI [2]
C0023895
eisenmenger syndrome with resting spo2 <88% on room air
Descripción

eisenmenger syndrome, SpO2

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013743
UMLS CUI [1,2]
C0428179
clinically relevant asthma or other chronic lung disease, such as bronchopulmonary dysplasia, cystic fibrosis, or repaired or unrepaired congenital diaphragmatic hernia
Descripción

chronic lung disease, asthma, bronchopulmonary dysplasia, cystic fibrosis, congenital diaphragmatic hernia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0746102
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C0006287
UMLS CUI [1,4]
C0010674
UMLS CUI [1,5]
C0235833
diagnosis or current evidence of active lung infection or clinically relevant hemoptysis
Descripción

lung infection, hemoptysis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0876973
UMLS CUI [2]
C0019079
left-sided heart disease, including valvular disease or heart failure
Descripción

left-sided heart disease, valvular disease, heart failure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0225809
UMLS CUI [1,3]
C0018824
UMLS CUI [1,4]
C0018801
initiation or dosage adjustment of pah-specific therapy within 3 months prior to screening
Descripción

pulmonary arterial hypertension therapy dosage adjustment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0420247
initiation of treatment with digoxin, diuretics, anticoagulation, or oxygen therapy within 30 days prior to screening
Descripción

digoxin, diuretics, anticoagulation, oxygen therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0012265
UMLS CUI [2]
C0012798
UMLS CUI [3]
C0449867
UMLS CUI [4]
C0184633
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Similar models

Eligibility Pulmonary Arterial Hypertension NCT00453414

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
gender, age
Item
male or female, age 3-18 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
pulmonary arterial hypertension due to idiopathic pulmonary arterial hypertension, connective tissue disease or congenital heart disease
Item
diagnosis of pah due to ipah, connective tissue disease, or congenital heart disease
boolean
C2973725 (UMLS CUI [1,1])
C3203102 (UMLS CUI [1,2])
C3697982 (UMLS CUI [1,3])
C3698160 (UMLS CUI [1,4])
cardiac catheterization, mpap, pcwp, lvedp, pvr
Item
pulmonary arterial hypertension confirmed by a cardiac catheterization, with mpap > 25 mmhg at rest, pcwp or lvedp ≤ 15 mmhg, and pvr ≥ 240 dynes/sec/cm-5 (ie, ≥ 3.0 units m2)
boolean
C0018795 (UMLS CUI [1,1])
C3854605 (UMLS CUI [1,2])
C0086879 (UMLS CUI [1,3])
C0456190 (UMLS CUI [1,4])
C0456261 (UMLS CUI [1,5])
nyha
Item
nyha/who functional class ii, iii, or iv
boolean
C1275491 (UMLS CUI [1])
6-minute walk test
Item
have had a 6-minute walk test (6-mwt) performed within the 3 months preceding the screening visit (if ≥ 8 years of age)
boolean
C0430515 (UMLS CUI [1])
cardiopulmonary exercise testing
Item
have had cardiopulmonary exercise testing (cpet) performed within the 3 months preceding the screening visit (if ≥ 8 years of age and > 130 cms in height. cpet testing will be conducted on nyha/who class iv patients at the discretion of the principal investigator)
boolean
C2959886 (UMLS CUI [1])
pulmonary arterial hypertension therapy
Item
if receiving therapy for pah, on a stable dose and regimen for at least 3 months prior to the screening visit
boolean
C2973725 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
digoxin, diuretic, oxygen therapy
Item
if receiving digoxin, diuretic, or oxygen therapy, on a stable dose and regimen for at least 30 days preceding the screening visit
boolean
C0012798 (UMLS CUI [1])
C0012265 (UMLS CUI [2])
C0184633 (UMLS CUI [3])
nebulizer use
Item
must demonstrate the ability to appropriately use the nebulizer device as part of the screening process
boolean
C0027524 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
prostacyclins
Item
prior use of prostacyclins or prostacyclin analogues within 3 months prior to screening
boolean
C0205911 (UMLS CUI [1])
portal hypertension, hepatic disease
Item
portal hypertension or clinically relevant hepatic disease
boolean
C0020541 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
eisenmenger syndrome, SpO2
Item
eisenmenger syndrome with resting spo2 <88% on room air
boolean
C0013743 (UMLS CUI [1,1])
C0428179 (UMLS CUI [1,2])
chronic lung disease, asthma, bronchopulmonary dysplasia, cystic fibrosis, congenital diaphragmatic hernia
Item
clinically relevant asthma or other chronic lung disease, such as bronchopulmonary dysplasia, cystic fibrosis, or repaired or unrepaired congenital diaphragmatic hernia
boolean
C0746102 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0006287 (UMLS CUI [1,3])
C0010674 (UMLS CUI [1,4])
C0235833 (UMLS CUI [1,5])
lung infection, hemoptysis
Item
diagnosis or current evidence of active lung infection or clinically relevant hemoptysis
boolean
C0876973 (UMLS CUI [1])
C0019079 (UMLS CUI [2])
left-sided heart disease, valvular disease, heart failure
Item
left-sided heart disease, including valvular disease or heart failure
boolean
C0018799 (UMLS CUI [1,1])
C0225809 (UMLS CUI [1,2])
C0018824 (UMLS CUI [1,3])
C0018801 (UMLS CUI [1,4])
pulmonary arterial hypertension therapy dosage adjustment
Item
initiation or dosage adjustment of pah-specific therapy within 3 months prior to screening
boolean
C2973725 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0420247 (UMLS CUI [1,3])
digoxin, diuretics, anticoagulation, oxygen therapy
Item
initiation of treatment with digoxin, diuretics, anticoagulation, or oxygen therapy within 30 days prior to screening
boolean
C0012265 (UMLS CUI [1])
C0012798 (UMLS CUI [2])
C0449867 (UMLS CUI [3])
C0184633 (UMLS CUI [4])
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