ID

31729

Description

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

Link

https://clinicaltrials.gov/show/NCT00637065

Keywords

Versions (2)
  1. 9/23/18 9/23/18 -
  2. 9/23/18 9/23/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 23, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Pulmonary Hypertension NCT00637065

English

Eligibility Pulmonary Hypertension NCT00637065

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

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.
Description

Idiopathic Pulmonary Fibrosis | Idiopathic nonspecific interstitial pneumonitis fibrotic

Data type

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).
Description

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

Data type

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.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

Age

Data type

boolean

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

Disease Unstable | Pulmonary Fibrosis Exacerbation

Data type

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.
Description

Organ Comorbidity | Hepatic impairment | Renal Insufficiency

Data type

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
Description

Systolic Pressure

Data type

boolean

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

Condition Affecting 6-Minute Walk Test

Data type

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.
Description

Informed Consent Unable | Protocol Compliance Unable

Data type

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).
Description

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

Data type

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.
Description

Surgical intervention Planned

Data type

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.
Description

Pregnancy | Childbearing Potential Contraceptive methods Absent

Data type

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.
Description

Myocardial Ischemia

Data type

boolean

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

Emphysema Predominant High resolution CT

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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