ID

40847

Descrição

First-line Bosentan and Sildenafil Combination Therapy for Pulmonary Arterial Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01247116

Link

https://clinicaltrials.gov/show/NCT01247116

Palavras-chave

Versões (1)
  1. 24/05/2020 24/05/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

24 de maio de 2020

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Hypertension, Pulmonary NCT01247116

Inglês

Eligibility Hypertension, Pulmonary NCT01247116

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with symptomatic functional class iii pah in the following categories: idiopathic (ipah), familial (fpah), associated with connective tissue disease, associated with drugs or toxins
Descrição

Pulmonary arterial hypertension Symptomatic Functional Status Class | Idiopathic pulmonary arterial hypertension | Familial pulmonary arterial hypertension | Connective Tissue Disease | Drugs | Toxins

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0598463
UMLS CUI [1,4]
C0456387
UMLS CUI [2]
C3203102
UMLS CUI [3]
C1701939
UMLS CUI [4]
C0009782
UMLS CUI [5]
C0242508
UMLS CUI [6]
C0040549
pah diagnosed by right heart catheterization, defined as: mean pulmonary arterial pressure (mpap) ≥ 25 mmhg, pvr > 3 mmhg/l/min (wood units) or > 240 dyn sec cm-5, pulmonary capillary wedge pressure (pcwp) ≤ 15 mmhg
Descrição

Pulmonary arterial hypertension Catheterization of right heart | Mean pulmonary arterial pressure | Pulmonary Vascular Resistance Wood units | Pulmonary Vascular Resistance | Pulmonary Capillary Wedge Pressure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0189896
UMLS CUI [2]
C3854605
UMLS CUI [3,1]
C0456261
UMLS CUI [3,2]
C0439525
UMLS CUI [4]
C0456261
UMLS CUI [5]
C0086879
baseline 6 mwt distance > 150 and < 450 m
Descrição

6 Minute Walk Functional Test Distance m

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3900196
UMLS CUI [1,2]
C0012751
UMLS CUI [1,3]
C0475209
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with eras other than bosentan;
Descrição

Endothelin receptor antagonist | Exception Bosentan

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1134681
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0252643
treatment with pde5 inhibitors other than sildenafil;
Descrição

Phosphodiesterase 5 inhibitor | Exception Sildenafil

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1318700
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0529793
treatment with any prostanoid;
Descrição

Prostaglandins

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0033554
pah associated with thyroid disorders, glycogen storage disease, gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders and splenectomy; valvular disease with valvular lesions to be excluded by echocardiogram within 2 years prior to randomization
Descrição

Pulmonary arterial hypertension Associated with Disease Specified | Thyroid Diseases | Glycogen Storage Disease | Gaucher Disease | Hereditary hemorrhagic telangiectasia | Hemoglobinopathies | Myeloproliferative disease | Splenectomy | Valvular disease | Valve Lesion Echocardiography

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0205369
UMLS CUI [2]
C0040128
UMLS CUI [3]
C0017919
UMLS CUI [4]
C0017205
UMLS CUI [5]
C0039445
UMLS CUI [6]
C0019045
UMLS CUI [7]
C0027022
UMLS CUI [8]
C0037995
UMLS CUI [9]
C3258293
UMLS CUI [10,1]
C1186983
UMLS CUI [10,2]
C0221198
UMLS CUI [10,3]
C0013516
restrictive lung disease: total lung capacity (tlc) < 60% of normal predicted value;
Descrição

Restrictive lung disease | Percent Predicted Total Lung Capacity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085581
UMLS CUI [2]
C3828589
obstructive lung disease: forced expiratory volume/forced vital capacity (fev1/fvc) < 50%
Descrição

Lung Diseases, Obstructive | FEV1/FVC percent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0600260
UMLS CUI [2]
C0730560
Voltar ao início da página

Similar models

Eligibility Hypertension, Pulmonary NCT01247116

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Pulmonary arterial hypertension Symptomatic Functional Status Class | Idiopathic pulmonary arterial hypertension | Familial pulmonary arterial hypertension | Connective Tissue Disease | Drugs | Toxins
Item
patients with symptomatic functional class iii pah in the following categories: idiopathic (ipah), familial (fpah), associated with connective tissue disease, associated with drugs or toxins
boolean
C2973725 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0598463 (UMLS CUI [1,3])
C0456387 (UMLS CUI [1,4])
C3203102 (UMLS CUI [2])
C1701939 (UMLS CUI [3])
C0009782 (UMLS CUI [4])
C0242508 (UMLS CUI [5])
C0040549 (UMLS CUI [6])
Pulmonary arterial hypertension Catheterization of right heart | Mean pulmonary arterial pressure | Pulmonary Vascular Resistance Wood units | Pulmonary Vascular Resistance | Pulmonary Capillary Wedge Pressure
Item
pah diagnosed by right heart catheterization, defined as: mean pulmonary arterial pressure (mpap) ≥ 25 mmhg, pvr > 3 mmhg/l/min (wood units) or > 240 dyn sec cm-5, pulmonary capillary wedge pressure (pcwp) ≤ 15 mmhg
boolean
C2973725 (UMLS CUI [1,1])
C0189896 (UMLS CUI [1,2])
C3854605 (UMLS CUI [2])
C0456261 (UMLS CUI [3,1])
C0439525 (UMLS CUI [3,2])
C0456261 (UMLS CUI [4])
C0086879 (UMLS CUI [5])
6 Minute Walk Functional Test Distance m
Item
baseline 6 mwt distance > 150 and < 450 m
boolean
C3900196 (UMLS CUI [1,1])
C0012751 (UMLS CUI [1,2])
C0475209 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Endothelin receptor antagonist | Exception Bosentan
Item
treatment with eras other than bosentan;
boolean
C1134681 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0252643 (UMLS CUI [2,2])
Phosphodiesterase 5 inhibitor | Exception Sildenafil
Item
treatment with pde5 inhibitors other than sildenafil;
boolean
C1318700 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0529793 (UMLS CUI [2,2])
Prostaglandins
Item
treatment with any prostanoid;
boolean
C0033554 (UMLS CUI [1])
Pulmonary arterial hypertension Associated with Disease Specified | Thyroid Diseases | Glycogen Storage Disease | Gaucher Disease | Hereditary hemorrhagic telangiectasia | Hemoglobinopathies | Myeloproliferative disease | Splenectomy | Valvular disease | Valve Lesion Echocardiography
Item
pah associated with thyroid disorders, glycogen storage disease, gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders and splenectomy; valvular disease with valvular lesions to be excluded by echocardiogram within 2 years prior to randomization
boolean
C2973725 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
C0040128 (UMLS CUI [2])
C0017919 (UMLS CUI [3])
C0017205 (UMLS CUI [4])
C0039445 (UMLS CUI [5])
C0019045 (UMLS CUI [6])
C0027022 (UMLS CUI [7])
C0037995 (UMLS CUI [8])
C3258293 (UMLS CUI [9])
C1186983 (UMLS CUI [10,1])
C0221198 (UMLS CUI [10,2])
C0013516 (UMLS CUI [10,3])
Restrictive lung disease | Percent Predicted Total Lung Capacity
Item
restrictive lung disease: total lung capacity (tlc) < 60% of normal predicted value;
boolean
C0085581 (UMLS CUI [1])
C3828589 (UMLS CUI [2])
Lung Diseases, Obstructive | FEV1/FVC percent
Item
obstructive lung disease: forced expiratory volume/forced vital capacity (fev1/fvc) < 50%
boolean
C0600260 (UMLS CUI [1])
C0730560 (UMLS CUI [2])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

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