ID

31502

Beskrivning

A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01028651

Länk

https://clinicaltrials.gov/show/NCT01028651

Nyckelord

Versioner (1)
  1. 2018-08-29 2018-08-29 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

29 augusti 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Portopulmonary Hypertension NCT01028651

Engelsk

Eligibility Portopulmonary Hypertension NCT01028651

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must:
Beskrivning

Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. confirmed severe poph documented on standard of care right-heart catheterization (rhc) with a plan to initiate treprostinil therapy, as recommended by the treating physician state within 30 days.
Beskrivning

Portopulmonary hypertension Severe | Standard of Care Catheterization of right heart | Treprostinil Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1868851
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C0189896
UMLS CUI [3,1]
C1145760
UMLS CUI [3,2]
C1301732
2. have portal hypertension.
Beskrivning

Hypertension, Portal

Datatyp

boolean

Alias
UMLS CUI [1]
C0020541
3. be otherwise suitable candidates for olt.
Beskrivning

Patients Appropriate Orthotopic liver transplant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0400447
4. treprostinil therapy must be recommended by the treating physician per standard of care.
Beskrivning

Treprostinil Standard of Care Recommended

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1145760
UMLS CUI [1,2]
C2936643
UMLS CUI [1,3]
C0034866
5. be nyha class ii, iii, or iv
Beskrivning

New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C1275491
6. have pulmonary capillary wedge pressure (pcw) < 18 mmhg and transpulmonary gradient (tpg) ≥ 15 mmhg severe pah is defined as a resting mean pulmonary artery pressure (mpa) > 25 mmhg and pulmonary vascular resistance (pvr) ≥ 3 wood-units by right-heart catheterization (rhc) performed as part of standard of care evaluation within 30 days of enrollment
Beskrivning

Pulmonary Capillary Wedge Pressure | Other Coding | Pulmonary arterial hypertension Severe | Pulmonary artery mean pressure Resting | Pulmonary Vascular Resistance Wood units | Catheterization of right heart | Standard of Care Evaluation

Datatyp

boolean

Alias
UMLS CUI [1]
C0086879
UMLS CUI [2]
C3846158
UMLS CUI [3,1]
C2973725
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0428645
UMLS CUI [4,2]
C0035253
UMLS CUI [5,1]
C0456261
UMLS CUI [5,2]
C0439525
UMLS CUI [6]
C0189896
UMLS CUI [7,1]
C2936643
UMLS CUI [7,2]
C1261322
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must not:
Beskrivning

Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. be taking any investigational therapy as part of a clinical trial for any indication within 30 days of enrollment.
Beskrivning

Study Subject Participation Status | Indication Investigational Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0949266
2. be receiving any vasodilator treatment for pulmonary hypertension (i.e. bosentan, sitaxsentan, ambrisentan, sildenafil, tadalafil, epoprostenol, beraprost, iloprost, inhaled treprostinil) at the time of enrollment.
Beskrivning

Vasodilator Agents Pulmonary Hypertension | bosentan | sitaxsentan | ambrisentan | sildenafil | tadalafil | Epoprostenol | beraprost | Iloprost | Treprostinil Inhaled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042402
UMLS CUI [1,2]
C0020542
UMLS CUI [2]
C0252643
UMLS CUI [3]
C1704271
UMLS CUI [4]
C1176329
UMLS CUI [5]
C0529793
UMLS CUI [6]
C1176316
UMLS CUI [7]
C0033567
UMLS CUI [8]
C0053336
UMLS CUI [9]
C0079594
UMLS CUI [10,1]
C1145760
UMLS CUI [10,2]
C0001559
3. exhibit renal failure requiring hemodialysis.
Beskrivning

Kidney Failure Requirement Hemodialysis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0019004
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Similar models

Eligibility Portopulmonary Hypertension NCT01028651

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
patients must:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Portopulmonary hypertension Severe | Standard of Care Catheterization of right heart | Treprostinil Planned
Item
1. confirmed severe poph documented on standard of care right-heart catheterization (rhc) with a plan to initiate treprostinil therapy, as recommended by the treating physician state within 30 days.
boolean
C1868851 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2936643 (UMLS CUI [2,1])
C0189896 (UMLS CUI [2,2])
C1145760 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Hypertension, Portal
Item
2. have portal hypertension.
boolean
C0020541 (UMLS CUI [1])
Patients Appropriate Orthotopic liver transplant
Item
3. be otherwise suitable candidates for olt.
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0400447 (UMLS CUI [1,3])
Treprostinil Standard of Care Recommended
Item
4. treprostinil therapy must be recommended by the treating physician per standard of care.
boolean
C1145760 (UMLS CUI [1,1])
C2936643 (UMLS CUI [1,2])
C0034866 (UMLS CUI [1,3])
New York Heart Association Classification
Item
5. be nyha class ii, iii, or iv
boolean
C1275491 (UMLS CUI [1])
Pulmonary Capillary Wedge Pressure | Other Coding | Pulmonary arterial hypertension Severe | Pulmonary artery mean pressure Resting | Pulmonary Vascular Resistance Wood units | Catheterization of right heart | Standard of Care Evaluation
Item
6. have pulmonary capillary wedge pressure (pcw) < 18 mmhg and transpulmonary gradient (tpg) ≥ 15 mmhg severe pah is defined as a resting mean pulmonary artery pressure (mpa) > 25 mmhg and pulmonary vascular resistance (pvr) ≥ 3 wood-units by right-heart catheterization (rhc) performed as part of standard of care evaluation within 30 days of enrollment
boolean
C0086879 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
C2973725 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0428645 (UMLS CUI [4,1])
C0035253 (UMLS CUI [4,2])
C0456261 (UMLS CUI [5,1])
C0439525 (UMLS CUI [5,2])
C0189896 (UMLS CUI [6])
C2936643 (UMLS CUI [7,1])
C1261322 (UMLS CUI [7,2])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
patients must not:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Study Subject Participation Status | Indication Investigational Therapy
Item
1. be taking any investigational therapy as part of a clinical trial for any indication within 30 days of enrollment.
boolean
C2348568 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0949266 (UMLS CUI [2,2])
Vasodilator Agents Pulmonary Hypertension | bosentan | sitaxsentan | ambrisentan | sildenafil | tadalafil | Epoprostenol | beraprost | Iloprost | Treprostinil Inhaled
Item
2. be receiving any vasodilator treatment for pulmonary hypertension (i.e. bosentan, sitaxsentan, ambrisentan, sildenafil, tadalafil, epoprostenol, beraprost, iloprost, inhaled treprostinil) at the time of enrollment.
boolean
C0042402 (UMLS CUI [1,1])
C0020542 (UMLS CUI [1,2])
C0252643 (UMLS CUI [2])
C1704271 (UMLS CUI [3])
C1176329 (UMLS CUI [4])
C0529793 (UMLS CUI [5])
C1176316 (UMLS CUI [6])
C0033567 (UMLS CUI [7])
C0053336 (UMLS CUI [8])
C0079594 (UMLS CUI [9])
C1145760 (UMLS CUI [10,1])
C0001559 (UMLS CUI [10,2])
Kidney Failure Requirement Hemodialysis
Item
3. exhibit renal failure requiring hemodialysis.
boolean
C0035078 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0019004 (UMLS CUI [1,3])
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