ID

22886

Beskrivning

Cardiopulmonary Function Assessment and NO-Based Therapies for Patients With Hemolysis-Associated Pulmonary Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00352430

Länk

https://clinicaltrials.gov/show/NCT00352430

Nyckelord

Versioner (1)
  1. 2017-06-14 2017-06-14 -
Uppladdad den

14 juni 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Pulmonary Hypertension NCT00352430

Engelsk

Eligibility Pulmonary Hypertension NCT00352430

1 Formulär  
Criteria
Beskrivning

Criteria

males or females, 18 years of age or older.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of sickle cell disease (electrophoretic documentation of ss, sc, or s thalassemia genotype is required) or thalassemia.
Beskrivning

Anemia, Sickle Cell | electrophoretic analysis of hemoglobin SS | electrophoretic analysis of hemoglobin SC | Hemoglobin S genotype Electrophoresis | Thalassemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0002895
UMLS CUI [2]
C2208594
UMLS CUI [3]
C2208592
UMLS CUI [4,1]
C1261533
UMLS CUI [4,2]
C0013855
UMLS CUI [5]
C0039730
for female subjects, on a reliable method of birth control or not physically able to bear children.
Beskrivning

Gender Contraceptive methods | Gender Infertility

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0021359
< tab>
Beskrivning

ID.4

Datatyp

boolean

for stage ii:
Beskrivning

WHO Pulmonary arterial hypertension Class Functional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0043237
UMLS CUI [1,2]
C2973725
UMLS CUI [1,3]
C0456387
UMLS CUI [1,4]
C0205245
mild to severe pulmonary hypertension with mean pulmonary artery pressure greater than 25 mm hg at rest or greater than 30 mm hg during exercise, measured by pulmonary artery catheterization.
Beskrivning

Pulmonary hypertension, mild | Pulmonary hypertension, severe | Pulmonary artery mean pressure At rest | Pulmonary artery mean pressure During Exercise | Pulmonary Artery Catheterization

Datatyp

boolean

Alias
UMLS CUI [1]
C3807623
UMLS CUI [2]
C2750273
UMLS CUI [3,1]
C0428645
UMLS CUI [3,2]
C0443144
UMLS CUI [4,1]
C0428645
UMLS CUI [4,2]
C0347984
UMLS CUI [4,3]
C0015259
UMLS CUI [5]
C0190658
pulmonary artery wedge pressure or left ventricular end-diastolic pressure less than or equal to 18 mm hg or gradient between pulmonary artery diastolic pressure and wedge pressure greater than 8 mm hg or echocardiographic criteria to exclude left ventricular dysfunction.
Beskrivning

Pulmonary Wedge Pressure | Left ventricular end-diastolic pressure measurement | Gradient Pulmonary artery diastolic pressure Pulmonary Wedge Pressure | Echocardiography criteria Left Ventricular Dysfunction Exclusion

Datatyp

boolean

Alias
UMLS CUI [1]
C0034094
UMLS CUI [2]
C1171395
UMLS CUI [3,1]
C0812409
UMLS CUI [3,2]
C0428644
UMLS CUI [3,3]
C0034094
UMLS CUI [4,1]
C0013516
UMLS CUI [4,2]
C0243161
UMLS CUI [4,3]
C0242698
UMLS CUI [4,4]
C2828389
for female subjects, on a reliable method of birth control or not physically able to bear children.
Beskrivning

Gender Contraceptive methods | Gender Infertility

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0021359
for stage iii:
Beskrivning

WHO Pulmonary arterial hypertension Class Functional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0043237
UMLS CUI [1,2]
C2973725
UMLS CUI [1,3]
C0456387
UMLS CUI [1,4]
C0205245
mild to severe pulmonary hypertension with mean pulmonary artery pressure greater than 25 mm hg at rest or greater than 30 mm hg during exercise, measured by pulmonary artery catheterization in patients on chronic sildenafil therapy for at least three months. patients receiving combination drug therapy with other drugs (e.g., endothelin antagonists, prostacyclins) are allowed to participate in stage iii as long as sildenafil is one of the components of the combination regimen.
Beskrivning

Pulmonary hypertension, mild | Pulmonary hypertension, severe | Pulmonary artery mean pressure At rest | Pulmonary artery mean pressure During Exercise | Pulmonary Artery Catheterization | sildenafil chronic | Combination Drug Therapy | Endothelin receptor antagonist | Prostaglandins I

Datatyp

boolean

Alias
UMLS CUI [1]
C3807623
UMLS CUI [2]
C2750273
UMLS CUI [3,1]
C0428645
UMLS CUI [3,2]
C0443144
UMLS CUI [4,1]
C0428645
UMLS CUI [4,2]
C0347984
UMLS CUI [4,3]
C0015259
UMLS CUI [5]
C0190658
UMLS CUI [6,1]
C0529793
UMLS CUI [6,2]
C0205191
UMLS CUI [7]
C0013218
UMLS CUI [8]
C1134681
UMLS CUI [9]
C0205911
pulmonary artery wedge pressure or left ventricular end-diastolic pressure less than or equal to 18 mm hg or gradient between pulmonary artery diastolic pressure and wedge pressure greater than 8 mm hg or echocardiographic criteria to exclude left ventricular dysfunction.
Beskrivning

Pulmonary Wedge Pressure | Left ventricular end-diastolic pressure measurement | Gradient Pulmonary artery diastolic pressure Pulmonary Wedge Pressure | Echocardiography criteria Left Ventricular Dysfunction Exclusion

Datatyp

boolean

Alias
UMLS CUI [1]
C0034094
UMLS CUI [2]
C1171395
UMLS CUI [3,1]
C0812409
UMLS CUI [3,2]
C0428644
UMLS CUI [3,3]
C0034094
UMLS CUI [4,1]
C0013516
UMLS CUI [4,2]
C0243161
UMLS CUI [4,3]
C0242698
UMLS CUI [4,4]
C2828389
must be on chronic sildenafil therapy on a stable dose for at least three months.
Beskrivning

Sildenafil chronic Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0529793
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
for female subjects, on a reliable method of birth control or not physically able to bear children.
Beskrivning

Gender Contraceptive methods | Gender Infertility

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0021359
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
for stage i
Beskrivning

WHO Pulmonary arterial hypertension Class Functional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0043237
UMLS CUI [1,2]
C2973725
UMLS CUI [1,3]
C0456387
UMLS CUI [1,4]
C0205245
current pregnancy or lactation.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any condition that in the opinion of the study investigators would adversely affect the outcome of the study or the safety of the volunteer.
Beskrivning

Condition Affecting research results | Condition Affecting patient safety

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C1113679
for stage ii and iii:
Beskrivning

WHO Pulmonary arterial hypertension Class Functional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0043237
UMLS CUI [1,2]
C2973725
UMLS CUI [1,3]
C0456387
UMLS CUI [1,4]
C0205245
current pregnancy or lactation.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any of the following medical conditions
Beskrivning

Medical condition

Datatyp

boolean

Alias
UMLS CUI [1]
C3843040
1. stroke within the last six weeks.
Beskrivning

Cerebrovascular accident

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
2. history of sustained priapism requiring medical or surgical treatment, unless currently impotent or on exchange transfusion therapy, within two years.
Beskrivning

Priapism Sustained Requirement Therapeutic procedure | Priapism Sustained Requirement Operative Surgical Procedures | Erectile dysfunction | Exchange Transfusion, Whole Blood

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033117
UMLS CUI [1,2]
C0443318
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C0033117
UMLS CUI [2,2]
C0443318
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C0543467
UMLS CUI [3]
C0242350
UMLS CUI [4]
C0015236
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Similar models

Eligibility Pulmonary Hypertension NCT00352430

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Age
Item
males or females, 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Anemia, Sickle Cell | electrophoretic analysis of hemoglobin SS | electrophoretic analysis of hemoglobin SC | Hemoglobin S genotype Electrophoresis | Thalassemia
Item
diagnosis of sickle cell disease (electrophoretic documentation of ss, sc, or s thalassemia genotype is required) or thalassemia.
boolean
C0002895 (UMLS CUI [1])
C2208594 (UMLS CUI [2])
C2208592 (UMLS CUI [3])
C1261533 (UMLS CUI [4,1])
C0013855 (UMLS CUI [4,2])
C0039730 (UMLS CUI [5])
Gender Contraceptive methods | Gender Infertility
Item
for female subjects, on a reliable method of birth control or not physically able to bear children.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0021359 (UMLS CUI [2,2])
ID.4
Item
< tab>
boolean
WHO Pulmonary arterial hypertension Class Functional
Item
for stage ii:
boolean
C0043237 (UMLS CUI [1,1])
C2973725 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
C0205245 (UMLS CUI [1,4])
Pulmonary hypertension, mild | Pulmonary hypertension, severe | Pulmonary artery mean pressure At rest | Pulmonary artery mean pressure During Exercise | Pulmonary Artery Catheterization
Item
mild to severe pulmonary hypertension with mean pulmonary artery pressure greater than 25 mm hg at rest or greater than 30 mm hg during exercise, measured by pulmonary artery catheterization.
boolean
C3807623 (UMLS CUI [1])
C2750273 (UMLS CUI [2])
C0428645 (UMLS CUI [3,1])
C0443144 (UMLS CUI [3,2])
C0428645 (UMLS CUI [4,1])
C0347984 (UMLS CUI [4,2])
C0015259 (UMLS CUI [4,3])
C0190658 (UMLS CUI [5])
Pulmonary Wedge Pressure | Left ventricular end-diastolic pressure measurement | Gradient Pulmonary artery diastolic pressure Pulmonary Wedge Pressure | Echocardiography criteria Left Ventricular Dysfunction Exclusion
Item
pulmonary artery wedge pressure or left ventricular end-diastolic pressure less than or equal to 18 mm hg or gradient between pulmonary artery diastolic pressure and wedge pressure greater than 8 mm hg or echocardiographic criteria to exclude left ventricular dysfunction.
boolean
C0034094 (UMLS CUI [1])
C1171395 (UMLS CUI [2])
C0812409 (UMLS CUI [3,1])
C0428644 (UMLS CUI [3,2])
C0034094 (UMLS CUI [3,3])
C0013516 (UMLS CUI [4,1])
C0243161 (UMLS CUI [4,2])
C0242698 (UMLS CUI [4,3])
C2828389 (UMLS CUI [4,4])
Gender Contraceptive methods | Gender Infertility
Item
for female subjects, on a reliable method of birth control or not physically able to bear children.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0021359 (UMLS CUI [2,2])
WHO Pulmonary arterial hypertension Class Functional
Item
for stage iii:
boolean
C0043237 (UMLS CUI [1,1])
C2973725 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
C0205245 (UMLS CUI [1,4])
Pulmonary hypertension, mild | Pulmonary hypertension, severe | Pulmonary artery mean pressure At rest | Pulmonary artery mean pressure During Exercise | Pulmonary Artery Catheterization | sildenafil chronic | Combination Drug Therapy | Endothelin receptor antagonist | Prostaglandins I
Item
mild to severe pulmonary hypertension with mean pulmonary artery pressure greater than 25 mm hg at rest or greater than 30 mm hg during exercise, measured by pulmonary artery catheterization in patients on chronic sildenafil therapy for at least three months. patients receiving combination drug therapy with other drugs (e.g., endothelin antagonists, prostacyclins) are allowed to participate in stage iii as long as sildenafil is one of the components of the combination regimen.
boolean
C3807623 (UMLS CUI [1])
C2750273 (UMLS CUI [2])
C0428645 (UMLS CUI [3,1])
C0443144 (UMLS CUI [3,2])
C0428645 (UMLS CUI [4,1])
C0347984 (UMLS CUI [4,2])
C0015259 (UMLS CUI [4,3])
C0190658 (UMLS CUI [5])
C0529793 (UMLS CUI [6,1])
C0205191 (UMLS CUI [6,2])
C0013218 (UMLS CUI [7])
C1134681 (UMLS CUI [8])
C0205911 (UMLS CUI [9])
Pulmonary Wedge Pressure | Left ventricular end-diastolic pressure measurement | Gradient Pulmonary artery diastolic pressure Pulmonary Wedge Pressure | Echocardiography criteria Left Ventricular Dysfunction Exclusion
Item
pulmonary artery wedge pressure or left ventricular end-diastolic pressure less than or equal to 18 mm hg or gradient between pulmonary artery diastolic pressure and wedge pressure greater than 8 mm hg or echocardiographic criteria to exclude left ventricular dysfunction.
boolean
C0034094 (UMLS CUI [1])
C1171395 (UMLS CUI [2])
C0812409 (UMLS CUI [3,1])
C0428644 (UMLS CUI [3,2])
C0034094 (UMLS CUI [3,3])
C0013516 (UMLS CUI [4,1])
C0243161 (UMLS CUI [4,2])
C0242698 (UMLS CUI [4,3])
C2828389 (UMLS CUI [4,4])
Sildenafil chronic Dose Stable
Item
must be on chronic sildenafil therapy on a stable dose for at least three months.
boolean
C0529793 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
Gender Contraceptive methods | Gender Infertility
Item
for female subjects, on a reliable method of birth control or not physically able to bear children.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0021359 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
WHO Pulmonary arterial hypertension Class Functional
Item
for stage i
boolean
C0043237 (UMLS CUI [1,1])
C2973725 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
C0205245 (UMLS CUI [1,4])
Pregnancy | Breast Feeding
Item
current pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Condition Affecting research results | Condition Affecting patient safety
Item
any condition that in the opinion of the study investigators would adversely affect the outcome of the study or the safety of the volunteer.
boolean
C0348080 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
WHO Pulmonary arterial hypertension Class Functional
Item
for stage ii and iii:
boolean
C0043237 (UMLS CUI [1,1])
C2973725 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
C0205245 (UMLS CUI [1,4])
Pregnancy | Breast Feeding
Item
current pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical condition
Item
any of the following medical conditions
boolean
C3843040 (UMLS CUI [1])
Cerebrovascular accident
Item
1. stroke within the last six weeks.
boolean
C0038454 (UMLS CUI [1])
Priapism Sustained Requirement Therapeutic procedure | Priapism Sustained Requirement Operative Surgical Procedures | Erectile dysfunction | Exchange Transfusion, Whole Blood
Item
2. history of sustained priapism requiring medical or surgical treatment, unless currently impotent or on exchange transfusion therapy, within two years.
boolean
C0033117 (UMLS CUI [1,1])
C0443318 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0033117 (UMLS CUI [2,1])
C0443318 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0543467 (UMLS CUI [2,4])
C0242350 (UMLS CUI [3])
C0015236 (UMLS CUI [4])
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