ID

31730

Descrição

Bosentan in Pulmonary Hypertension in Interstitial Lung Disease Treatment Study; ODM derived from: https://clinicaltrials.gov/show/NCT00637065

Link

https://clinicaltrials.gov/show/NCT00637065

Palavras-chave

Versões (2)
  1. 23/09/2018 23/09/2018 -
  2. 23/09/2018 23/09/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

23 de setembro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Pulmonary Hypertension NCT00637065

Inglês

Eligibility Pulmonary Hypertension NCT00637065

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients >=18yrs, <80yrs
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with idiopathic pulmonary fibrosis (ipf) or idiopathic fibrotic non-specific interstitial pneumonitis (nsip) confirmed by their respiratory physician according to ats/ers criteria.
Descrição

Idiopathic Pulmonary Fibrosis | Idiopathic nonspecific interstitial pneumonitis fibrotic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1800706
UMLS CUI [2,1]
C3250406
UMLS CUI [2,2]
C0334129
3. patients with pulmonary hypertension on right heart catheter (mean pulmonary arterial pressure >=25mmhg with pulmonary artery occlusion pressure, left atrial pressure or left ventricular end-diastolic pressure <15mmhg).
Descrição

Pulmonary Hypertension Catheterization of right heart | Mean pulmonary arterial pressure | Pulmonary Artery Occlusion Pressure | Left atrial pressure | Left ventricular end-diastolic pressure measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0189896
UMLS CUI [2]
C3854605
UMLS CUI [3]
C0034094
UMLS CUI [4]
C0456170
UMLS CUI [5]
C1171395
4. patients providing written informed consent.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients <18, >80yrs.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with unstable disease, or an acute exacerbation of their underlying fibrotic lung disease.
Descrição

Disease Unstable | Pulmonary Fibrosis Exacerbation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0034069
UMLS CUI [2,2]
C4086268
3. patients with significant other organ co-morbidity including hepatic or renal impairment.
Descrição

Organ Comorbidity | Hepatic impairment | Renal Insufficiency

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0009488
UMLS CUI [2]
C0948807
UMLS CUI [3]
C1565489
4. patients with systolic bp < 85mmhg
Descrição

Systolic Pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0871470
5. patients with other conditions that may affect the ability to perform a 6-minute walk test.
Descrição

Condition Affecting 6-Minute Walk Test

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0430515
6. patients unable to provide informed consent and comply with the patient protocol.
Descrição

Informed Consent Unable | Protocol Compliance Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
7. patients receiving excluded medications (including: epoprostenol, or prostacyclin analogues, phosphodiesterase inhibitors, other endothelin receptor antagonists, drugs with potential interaction with bosentan such as glibenclamide, fluconazole, cyclosporin a, or tacrolimus, and other investigational agents).
Descrição

Pharmaceutical Preparations Excluded | Epoprostenol | Prostaglandin Analog | Phosphodiesterase Inhibitors | Endothelin receptor antagonist | Pharmaceutical Preparations Interaction Bosentan | Glyburide | Fluconazole | Cyclosporine | Tacrolimus | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332196
UMLS CUI [2]
C0033567
UMLS CUI [3]
C3536889
UMLS CUI [4]
C0031638
UMLS CUI [5]
C1134681
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C1704675
UMLS CUI [6,3]
C0252643
UMLS CUI [7]
C0017628
UMLS CUI [8]
C0016277
UMLS CUI [9]
C0010592
UMLS CUI [10]
C0085149
UMLS CUI [11]
C0013230
8. patients with planned surgical intervention during the study period.
Descrição

Surgical intervention Planned

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0549433
UMLS CUI [1,2]
C1301732
9. pregnant patients or women of child-bearing age, who are not using a reliable contraceptive method.
Descrição

Pregnancy | Childbearing Potential Contraceptive methods Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
10. patients with clinically overt ischaemic heart disease.
Descrição

Myocardial Ischemia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151744
11. patients with predominant emphysema on high resolution ct scan (emphysema greater in extent than interstitial changes).
Descrição

Emphysema Predominant High resolution CT

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0034067
UMLS CUI [1,2]
C1542147
UMLS CUI [1,3]
C1512457
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Similar models

Eligibility Pulmonary Hypertension NCT00637065

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patients >=18yrs, <80yrs
boolean
C0001779 (UMLS CUI [1])
Idiopathic Pulmonary Fibrosis | Idiopathic nonspecific interstitial pneumonitis fibrotic
Item
2. patients with idiopathic pulmonary fibrosis (ipf) or idiopathic fibrotic non-specific interstitial pneumonitis (nsip) confirmed by their respiratory physician according to ats/ers criteria.
boolean
C1800706 (UMLS CUI [1])
C3250406 (UMLS CUI [2,1])
C0334129 (UMLS CUI [2,2])
Pulmonary Hypertension Catheterization of right heart | Mean pulmonary arterial pressure | Pulmonary Artery Occlusion Pressure | Left atrial pressure | Left ventricular end-diastolic pressure measurement
Item
3. patients with pulmonary hypertension on right heart catheter (mean pulmonary arterial pressure >=25mmhg with pulmonary artery occlusion pressure, left atrial pressure or left ventricular end-diastolic pressure <15mmhg).
boolean
C0020542 (UMLS CUI [1,1])
C0189896 (UMLS CUI [1,2])
C3854605 (UMLS CUI [2])
C0034094 (UMLS CUI [3])
C0456170 (UMLS CUI [4])
C1171395 (UMLS CUI [5])
Informed Consent
Item
4. patients providing written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
1. patients <18, >80yrs.
boolean
C0001779 (UMLS CUI [1])
Disease Unstable | Pulmonary Fibrosis Exacerbation
Item
2. patients with unstable disease, or an acute exacerbation of their underlying fibrotic lung disease.
boolean
C0012634 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0034069 (UMLS CUI [2,1])
C4086268 (UMLS CUI [2,2])
Organ Comorbidity | Hepatic impairment | Renal Insufficiency
Item
3. patients with significant other organ co-morbidity including hepatic or renal impairment.
boolean
C0178784 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0948807 (UMLS CUI [2])
C1565489 (UMLS CUI [3])
Systolic Pressure
Item
4. patients with systolic bp < 85mmhg
boolean
C0871470 (UMLS CUI [1])
Condition Affecting 6-Minute Walk Test
Item
5. patients with other conditions that may affect the ability to perform a 6-minute walk test.
boolean
C0348080 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0430515 (UMLS CUI [1,3])
Informed Consent Unable | Protocol Compliance Unable
Item
6. patients unable to provide informed consent and comply with the patient protocol.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Pharmaceutical Preparations Excluded | Epoprostenol | Prostaglandin Analog | Phosphodiesterase Inhibitors | Endothelin receptor antagonist | Pharmaceutical Preparations Interaction Bosentan | Glyburide | Fluconazole | Cyclosporine | Tacrolimus | Investigational New Drugs
Item
7. patients receiving excluded medications (including: epoprostenol, or prostacyclin analogues, phosphodiesterase inhibitors, other endothelin receptor antagonists, drugs with potential interaction with bosentan such as glibenclamide, fluconazole, cyclosporin a, or tacrolimus, and other investigational agents).
boolean
C0013227 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0033567 (UMLS CUI [2])
C3536889 (UMLS CUI [3])
C0031638 (UMLS CUI [4])
C1134681 (UMLS CUI [5])
C0013227 (UMLS CUI [6,1])
C1704675 (UMLS CUI [6,2])
C0252643 (UMLS CUI [6,3])
C0017628 (UMLS CUI [7])
C0016277 (UMLS CUI [8])
C0010592 (UMLS CUI [9])
C0085149 (UMLS CUI [10])
C0013230 (UMLS CUI [11])
Surgical intervention Planned
Item
8. patients with planned surgical intervention during the study period.
boolean
C0549433 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Pregnancy | Childbearing Potential Contraceptive methods Absent
Item
9. pregnant patients or women of child-bearing age, who are not using a reliable contraceptive method.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Myocardial Ischemia
Item
10. patients with clinically overt ischaemic heart disease.
boolean
C0151744 (UMLS CUI [1])
Emphysema Predominant High resolution CT
Item
11. patients with predominant emphysema on high resolution ct scan (emphysema greater in extent than interstitial changes).
boolean
C0034067 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C1512457 (UMLS CUI [1,3])
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