ID

31703

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00544726

Stichworte

Versionen (2)
  1. 21.09.18 21.09.18 -
  2. 21.09.18 21.09.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

21. September 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Pulmonary Arterial Hypertension NCT00544726

Englisch

Eligibility Pulmonary Arterial Hypertension NCT00544726

1 Formulare  
Inclusion Criteria
Beschreibung

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Participation Rehabilitation therapy Frequency | Participation Follow-up

Datentyp

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.
Beschreibung

Medication dose Stable Pulmonary arterial hypertension

Datentyp

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.
Beschreibung

New York Heart Association Classification

Datentyp

boolean

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

Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy Test

Datentyp

boolean

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

Exclusion Criteria

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

New York Heart Association Classification

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Comorbidity Hospitalization Required

Datentyp

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.
Beschreibung

Other medical condition Interferes with Participation Rehabilitation therapy | Musculoskeletal Diseases

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Participation Rehabilitation therapy Other

Datentyp

boolean

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

Study Subject Participation Status

Datentyp

boolean

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

Pregnancy | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Pulmonary Arterial Hypertension NCT00544726

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video