ID

31703

Beskrivning

Rehabilitation for Patients With Pulmonary Arterial Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00544726

Länk

https://clinicaltrials.gov/show/NCT00544726

Nyckelord

Versioner (2)
  1. 2018-09-21 2018-09-21 -
  2. 2018-09-21 2018-09-21 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

21 september 2018

DOI

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Creative Commons BY 4.0
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Eligibility Pulmonary Arterial Hypertension NCT00544726

Engelsk

Eligibility Pulmonary Arterial Hypertension NCT00544726

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients must satisfy current diagnostic criteria for pulmonary artery hypertension based on their historical right heart catheter data (within 4 years of study enrollment): mean pap >25mmhg at rest or >30mmhg with exercise, by a pcwp <= 15mmhg and by pvr >3 wood units.
Beskrivning

Pulmonary arterial hypertension Right heart Catheter Data | Mean pulmonary arterial pressure At rest | Mean pulmonary arterial pressure Exercise induced | Pulmonary Capillary Wedge Pressure | Pulmonary Vascular Resistance Wood units Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0225808
UMLS CUI [1,3]
C0085590
UMLS CUI [1,4]
C1511726
UMLS CUI [2,1]
C3854605
UMLS CUI [2,2]
C0443144
UMLS CUI [3,1]
C3854605
UMLS CUI [3,2]
C0239313
UMLS CUI [4]
C0086879
UMLS CUI [5,1]
C0456261
UMLS CUI [5,2]
C0439525
UMLS CUI [5,3]
C1265611
willing and able to participate in 24 bi-weekly rehabilitation sessions, and medical follow-up.
Beskrivning

Participation Rehabilitation therapy Frequency | Participation Follow-up

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0034991
UMLS CUI [1,3]
C0439603
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C3274571
stable dose of current pah-specific medication for 3 months prior to enrollment.
Beskrivning

Medication dose Stable Pulmonary arterial hypertension

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C2973725
new york heart association (nyha) class ii-iii.
Beskrivning

New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C1275491
women of child-bearing age must demonstrate adequate contraception or undergo a pregnancy test.
Beskrivning

Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy Test

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032976
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
functional class nyha class i or iv.
Beskrivning

New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C1275491
pah due to congenital heart disease, left heart disease, chronic lung diseases (vc or fev1 < 60% of predicted) or chronic hypoxia.
Beskrivning

Pulmonary arterial hypertension Due to Congenital heart disease | Pulmonary hypertension due to left heart disease | Pulmonary arterial hypertension Due to Chronic lung disease | Vital capacity | FEV1 | Pulmonary arterial hypertension Due to HYPOXIA CHRONIC

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0152021
UMLS CUI [2]
C3532326
UMLS CUI [3,1]
C2973725
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0746102
UMLS CUI [4]
C0042834
UMLS CUI [5]
C0849974
UMLS CUI [6,1]
C2973725
UMLS CUI [6,2]
C0678226
UMLS CUI [6,3]
C0745190
acute intercurrent illness requiring hospital admission in the month proceeding screening.
Beskrivning

Comorbidity Hospitalization Required

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1708385
any non-pah medical condition likely to interfere with participation in rehabilitation, e.g. musculoskeletal disorders.
Beskrivning

Other medical condition Interferes with Participation Rehabilitation therapy | Musculoskeletal Diseases

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0679823
UMLS CUI [1,4]
C0034991
UMLS CUI [2]
C0026857
any uncontrolled or terminal non-pah medical condition likely to interfere with completion of the study, according to the judgment of the study physician.
Beskrivning

Medical condition Uncontrolled Interferes with Completion of clinical trial | Condition terminal Interferes with Completion of clinical trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2732579
UMLS CUI [2,1]
C2051439
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2732579
participation in another rehabilitation scheme within 6 months of enrollment in the study.
Beskrivning

Participation Rehabilitation therapy Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0034991
UMLS CUI [1,3]
C0205394
current participation in another clinical trial.
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
pregnancy or planned pregnancy during the study period.
Beskrivning

Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
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Similar models

Eligibility Pulmonary Arterial Hypertension NCT00544726

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Pulmonary arterial hypertension Right heart Catheter Data | Mean pulmonary arterial pressure At rest | Mean pulmonary arterial pressure Exercise induced | Pulmonary Capillary Wedge Pressure | Pulmonary Vascular Resistance Wood units Quantity
Item
all patients must satisfy current diagnostic criteria for pulmonary artery hypertension based on their historical right heart catheter data (within 4 years of study enrollment): mean pap >25mmhg at rest or >30mmhg with exercise, by a pcwp <= 15mmhg and by pvr >3 wood units.
boolean
C2973725 (UMLS CUI [1,1])
C0225808 (UMLS CUI [1,2])
C0085590 (UMLS CUI [1,3])
C1511726 (UMLS CUI [1,4])
C3854605 (UMLS CUI [2,1])
C0443144 (UMLS CUI [2,2])
C3854605 (UMLS CUI [3,1])
C0239313 (UMLS CUI [3,2])
C0086879 (UMLS CUI [4])
C0456261 (UMLS CUI [5,1])
C0439525 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
Participation Rehabilitation therapy Frequency | Participation Follow-up
Item
willing and able to participate in 24 bi-weekly rehabilitation sessions, and medical follow-up.
boolean
C0679823 (UMLS CUI [1,1])
C0034991 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C0679823 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
Medication dose Stable Pulmonary arterial hypertension
Item
stable dose of current pah-specific medication for 3 months prior to enrollment.
boolean
C3174092 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C2973725 (UMLS CUI [1,3])
New York Heart Association Classification
Item
new york heart association (nyha) class ii-iii.
boolean
C1275491 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy Test
Item
women of child-bearing age must demonstrate adequate contraception or undergo a pregnancy test.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
New York Heart Association Classification
Item
functional class nyha class i or iv.
boolean
C1275491 (UMLS CUI [1])
Pulmonary arterial hypertension Due to Congenital heart disease | Pulmonary hypertension due to left heart disease | Pulmonary arterial hypertension Due to Chronic lung disease | Vital capacity | FEV1 | Pulmonary arterial hypertension Due to HYPOXIA CHRONIC
Item
pah due to congenital heart disease, left heart disease, chronic lung diseases (vc or fev1 < 60% of predicted) or chronic hypoxia.
boolean
C2973725 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0152021 (UMLS CUI [1,3])
C3532326 (UMLS CUI [2])
C2973725 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0746102 (UMLS CUI [3,3])
C0042834 (UMLS CUI [4])
C0849974 (UMLS CUI [5])
C2973725 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C0745190 (UMLS CUI [6,3])
Comorbidity Hospitalization Required
Item
acute intercurrent illness requiring hospital admission in the month proceeding screening.
boolean
C0009488 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
Other medical condition Interferes with Participation Rehabilitation therapy | Musculoskeletal Diseases
Item
any non-pah medical condition likely to interfere with participation in rehabilitation, e.g. musculoskeletal disorders.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0679823 (UMLS CUI [1,3])
C0034991 (UMLS CUI [1,4])
C0026857 (UMLS CUI [2])
Medical condition Uncontrolled Interferes with Completion of clinical trial | Condition terminal Interferes with Completion of clinical trial
Item
any uncontrolled or terminal non-pah medical condition likely to interfere with completion of the study, according to the judgment of the study physician.
boolean
C3843040 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
C2051439 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
Participation Rehabilitation therapy Other
Item
participation in another rehabilitation scheme within 6 months of enrollment in the study.
boolean
C0679823 (UMLS CUI [1,1])
C0034991 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Study Subject Participation Status
Item
current participation in another clinical trial.
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned
Item
pregnancy or planned pregnancy during the study period.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
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