ID

31681

Beschrijving

COMPERA / COMPERA-KIDS; ODM derived from: https://clinicaltrials.gov/show/NCT01347216

Link

https://clinicaltrials.gov/show/NCT01347216

Trefwoorden

Versies (1)
  1. 20-09-18 20-09-18 -
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See clinicaltrials.gov

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20 september 2018

DOI

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Creative Commons BY 4.0
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Eligibility Pulmonary Arterial Hypertension (PAH) NCT01347216

Engels

Eligibility Pulmonary Arterial Hypertension (PAH) NCT01347216

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
all age groups (amendment dated 1 june 2013)
Beschrijving

Age Groups All

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027362
UMLS CUI [1,2]
C0444868
written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
pulmonary hypertension (ph) of either
Beschrijving

Pulmonary Hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0020542
pah: idiopathic form (ipah) or
Beschrijving

Pulmonary arterial hypertension | Idiopathic pulmonary arterial hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C2973725
UMLS CUI [2]
C3203102
pah associated with connective tissue diseases (pah-ctd), with congenital heart defects (pah-chd), with hiv infection (pah-hiv), or the portopulmonary form
Beschrijving

Pulmonary arterial hypertension associated with connective tissue disease | Pulmonary arterial hypertension associated with congenital heart disease | Pulmonary arterial hypertension associated with HIV infection | Portopulmonary hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C3697982
UMLS CUI [2]
C3697119
UMLS CUI [3]
C3697673
UMLS CUI [4]
C1868851
chronic thromboembolic ph (cteph)
Beschrijving

Chronic thromboembolic pulmonary hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C2363973
ph in left heart diseases (with isolated diastolic dysfunction; with systolic dysfunction, other)
Beschrijving

Pulmonary hypertension due to left heart disease | Pulmonary hypertension due to left heart disease Associated with Isolated Diastolic dysfunction | Pulmonary hypertension due to left heart disease Associated with Systolic dysfunction

Datatype

boolean

Alias
UMLS CUI [1]
C3532326
UMLS CUI [2,1]
C3532326
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0520863
UMLS CUI [2,4]
C0205409
UMLS CUI [3,1]
C3532326
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0749225
ph in pulmonary disease (chronic obstructive pulmonary disease; interstitial fibrosis, etc.)
Beschrijving

Pulmonary Hypertension Due to Lung disease | Pulmonary hypertension due to chronic obstructive pulmonary disease | Pulmonary Hypertension Due to Interstitial fibrosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0024115
UMLS CUI [2]
C3696884
UMLS CUI [3,1]
C0020542
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C3887486
"relative ph" in chd after cavopulmonary anastomosis or fontan-type surgery, even without the classical pulmonary pressure criteria of ph.
Beschrijving

Pulmonary Hypertension Due to Congenital heart disease | Status post Cavopulmonary anastomosis | Status post Fontan type operation |

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0152021
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0242838
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0190010
newly initiated (i.e. a maximum of 3 months before documentation for the first time) therapy with era, pde-5 inhibitors or prostacyclins in mono- or combination therapy.
Beschrijving

Therapeutic procedure Initiation | Endothelin receptor antagonist | Phosphodiesterase 5 inhibitor | Prostacyclin | Combined Modality Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1704686
UMLS CUI [2]
C1134681
UMLS CUI [3]
C1318700
UMLS CUI [4]
C0033567
UMLS CUI [5]
C0009429
exceptions: pah-chd patients can be included on maintenance or newly initiated pah therapy (3-month rule dose not apply).
Beschrijving

Exception | Maintenance therapy Including Pulmonary arterial hypertension associated with congenital heart disease | Therapeutic procedure Initiation Including Pulmonary arterial hypertension associated with congenital heart disease

Datatype

boolean

Alias
UMLS CUI [1]
C1705847
UMLS CUI [2,1]
C0677908
UMLS CUI [2,2]
C0332257
UMLS CUI [2,3]
C3697119
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1704686
UMLS CUI [3,3]
C0332257
UMLS CUI [3,4]
C3697119
pah-chd patients with severe pulmonary vascular disease (e.g. eisenmenger physiology) irrespective of treatment with any pah drugs are eligible for inclusion, too.
Beschrijving

Pulmonary arterial hypertension with congenital heart disease Associated with Vascular disease of lung Severe | Eisenmenger Complex

Datatype

boolean

Alias
UMLS CUI [1,1]
C3697119
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0543826
UMLS CUI [1,4]
C0205082
UMLS CUI [2]
C0013743
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients on maintenance therapy, i.e. previous treatment with any era/
Beschrijving

Maintenance therapy | Prior Therapy Endothelin receptor antagonist

Datatype

boolean

Alias
UMLS CUI [1]
C0677908
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C1134681
pde-v-inhibitor/prostacyclin/sgc stimulator drug longer than 3 months before documentation for the first time (exception: pah-chd patients).
Beschrijving

Phosphodiesterase 5 inhibitor | prostacyclin | soluble guanylyl cyclase | Exception Pulmonary arterial hypertension associated with congenital heart disease

Datatype

boolean

Alias
UMLS CUI [1]
C1318700
UMLS CUI [2]
C0033567
UMLS CUI [3]
C1097411
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C3697119
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Similar models

Eligibility Pulmonary Arterial Hypertension (PAH) NCT01347216

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age Groups All
Item
all age groups (amendment dated 1 june 2013)
boolean
C0027362 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Pulmonary Hypertension
Item
pulmonary hypertension (ph) of either
boolean
C0020542 (UMLS CUI [1])
Pulmonary arterial hypertension | Idiopathic pulmonary arterial hypertension
Item
pah: idiopathic form (ipah) or
boolean
C2973725 (UMLS CUI [1])
C3203102 (UMLS CUI [2])
Pulmonary arterial hypertension associated with connective tissue disease | Pulmonary arterial hypertension associated with congenital heart disease | Pulmonary arterial hypertension associated with HIV infection | Portopulmonary hypertension
Item
pah associated with connective tissue diseases (pah-ctd), with congenital heart defects (pah-chd), with hiv infection (pah-hiv), or the portopulmonary form
boolean
C3697982 (UMLS CUI [1])
C3697119 (UMLS CUI [2])
C3697673 (UMLS CUI [3])
C1868851 (UMLS CUI [4])
Chronic thromboembolic pulmonary hypertension
Item
chronic thromboembolic ph (cteph)
boolean
C2363973 (UMLS CUI [1])
Pulmonary hypertension due to left heart disease | Pulmonary hypertension due to left heart disease Associated with Isolated Diastolic dysfunction | Pulmonary hypertension due to left heart disease Associated with Systolic dysfunction
Item
ph in left heart diseases (with isolated diastolic dysfunction; with systolic dysfunction, other)
boolean
C3532326 (UMLS CUI [1])
C3532326 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0520863 (UMLS CUI [2,3])
C0205409 (UMLS CUI [2,4])
C3532326 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0749225 (UMLS CUI [3,3])
Pulmonary Hypertension Due to Lung disease | Pulmonary hypertension due to chronic obstructive pulmonary disease | Pulmonary Hypertension Due to Interstitial fibrosis
Item
ph in pulmonary disease (chronic obstructive pulmonary disease; interstitial fibrosis, etc.)
boolean
C0020542 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0024115 (UMLS CUI [1,3])
C3696884 (UMLS CUI [2])
C0020542 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C3887486 (UMLS CUI [3,3])
Pulmonary Hypertension Due to Congenital heart disease | Status post Cavopulmonary anastomosis | Status post Fontan type operation |
Item
"relative ph" in chd after cavopulmonary anastomosis or fontan-type surgery, even without the classical pulmonary pressure criteria of ph.
boolean
C0020542 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0152021 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0242838 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0190010 (UMLS CUI [3,2])
Therapeutic procedure Initiation | Endothelin receptor antagonist | Phosphodiesterase 5 inhibitor | Prostacyclin | Combined Modality Therapy
Item
newly initiated (i.e. a maximum of 3 months before documentation for the first time) therapy with era, pde-5 inhibitors or prostacyclins in mono- or combination therapy.
boolean
C0087111 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])
C1134681 (UMLS CUI [2])
C1318700 (UMLS CUI [3])
C0033567 (UMLS CUI [4])
C0009429 (UMLS CUI [5])
Exception | Maintenance therapy Including Pulmonary arterial hypertension associated with congenital heart disease | Therapeutic procedure Initiation Including Pulmonary arterial hypertension associated with congenital heart disease
Item
exceptions: pah-chd patients can be included on maintenance or newly initiated pah therapy (3-month rule dose not apply).
boolean
C1705847 (UMLS CUI [1])
C0677908 (UMLS CUI [2,1])
C0332257 (UMLS CUI [2,2])
C3697119 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C1704686 (UMLS CUI [3,2])
C0332257 (UMLS CUI [3,3])
C3697119 (UMLS CUI [3,4])
Pulmonary arterial hypertension with congenital heart disease Associated with Vascular disease of lung Severe | Eisenmenger Complex
Item
pah-chd patients with severe pulmonary vascular disease (e.g. eisenmenger physiology) irrespective of treatment with any pah drugs are eligible for inclusion, too.
boolean
C3697119 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0543826 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
C0013743 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Maintenance therapy | Prior Therapy Endothelin receptor antagonist
Item
patients on maintenance therapy, i.e. previous treatment with any era/
boolean
C0677908 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C1134681 (UMLS CUI [2,2])
Phosphodiesterase 5 inhibitor | prostacyclin | soluble guanylyl cyclase | Exception Pulmonary arterial hypertension associated with congenital heart disease
Item
pde-v-inhibitor/prostacyclin/sgc stimulator drug longer than 3 months before documentation for the first time (exception: pah-chd patients).
boolean
C1318700 (UMLS CUI [1])
C0033567 (UMLS CUI [2])
C1097411 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C3697119 (UMLS CUI [4,2])
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