ID

12780

Beskrivning

Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00581607

Länk

https://clinicaltrials.gov/show/NCT00581607

Nyckelord

  1. 2015-12-21 2015-12-21 -
Uppladdad den

21 december 2015

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Sarcoidosis NCT00581607

Eligibility Sarcoidosis NCT00581607

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with known sarcoidosis 21.
Beskrivning

sarcoidosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0036202
age 18 or greater
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patients with documented pulmonary hypertension with a pa mean > 25 mm hg as measured by cardiac catheterization within six months of entry into the study. pulmonary artery occluding pressure and or left ventricular end diastolic pressure must be less than 15 mm hg.
Beskrivning

pulmonary hypertension; Cardiac Catheterization

Datatyp

boolean

Alias
UMLS CUI [1]
C0020542
UMLS CUI [2]
C0018795
patients with who class ii or iii
Beskrivning

who class

Datatyp

boolean

Alias
UMLS CUI [1]
C0451584
six minute walk distance of between 100 to 500 meters
Beskrivning

walking

Datatyp

boolean

Alias
UMLS CUI [1]
C0080331
patients on stable immunotherapy for their sarcoidosis, including prednisone, methotrexate, azathioprine, hydroxychloroquine, cyclophosphamide, thalidomide, and/or infliximab
Beskrivning

immunotherapy sarcoidosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0036202
patients able to provide written consent
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients on pulmonary vasodilator drugs (flolan, remodulin, bosentan, sildenafil) n the prior 28 days. patients on stable dose of calcium channel blocker for more than 1 month prior to right heart catheterization can be continued on the calcium channel blocker.
Beskrivning

Vasodilator Agents; calcium channel blocker

Datatyp

boolean

Alias
UMLS CUI [1]
C0042402
UMLS CUI [2]
C0006684
patients with severe airway obstruction as defined by fev1/fvc of less than 35%
Beskrivning

Airway Obstruction; fev1

Datatyp

boolean

Alias
UMLS CUI [1]
C0001883
UMLS CUI [2]
C0588029
patients with world health organization (who) class iv status.
Beskrivning

who class

Datatyp

boolean

Alias
UMLS CUI [1]
C0451584
patients who are pregnant or breast feeding
Beskrivning

pregnant; lactating

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2828358
UMLS CUI [1,2]
C0549206
patients with significant left ventricular dysfunction with a left ventricular ejection fraction of less than 35%
Beskrivning

left ventricular dysfunction

Datatyp

boolean

Alias
UMLS CUI [1]
C0242698
cardiac index < 2.0 liters and/or right atrial pressure >15 mm hg
Beskrivning

cardiac index; right atrial pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0428776
UMLS CUI [2]
C0456165
significant liver dysfunction not due to sarcoidosis.
Beskrivning

liver dysfunction

Datatyp

boolean

Alias
UMLS CUI [1]
C0086565
patients with severe other organ disease felt by investigators to impact on survival during the course of the study.
Beskrivning

compliance behavior limited comorbidity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
patients unable to perform the 6 minute walk study
Beskrivning

walking

Datatyp

boolean

Alias
UMLS CUI [1]
C0080331

Similar models

Eligibility Sarcoidosis NCT00581607

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
sarcoidosis
Item
patients with known sarcoidosis 21.
boolean
C0036202 (UMLS CUI [1])
age
Item
age 18 or greater
boolean
C0001779 (UMLS CUI [1])
pulmonary hypertension; Cardiac Catheterization
Item
patients with documented pulmonary hypertension with a pa mean > 25 mm hg as measured by cardiac catheterization within six months of entry into the study. pulmonary artery occluding pressure and or left ventricular end diastolic pressure must be less than 15 mm hg.
boolean
C0020542 (UMLS CUI [1])
C0018795 (UMLS CUI [2])
who class
Item
patients with who class ii or iii
boolean
C0451584 (UMLS CUI [1])
walking
Item
six minute walk distance of between 100 to 500 meters
boolean
C0080331 (UMLS CUI [1])
immunotherapy sarcoidosis
Item
patients on stable immunotherapy for their sarcoidosis, including prednisone, methotrexate, azathioprine, hydroxychloroquine, cyclophosphamide, thalidomide, and/or infliximab
boolean
C0021083 (UMLS CUI [1,1])
C0036202 (UMLS CUI [1,2])
informed consent
Item
patients able to provide written consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Vasodilator Agents; calcium channel blocker
Item
patients on pulmonary vasodilator drugs (flolan, remodulin, bosentan, sildenafil) n the prior 28 days. patients on stable dose of calcium channel blocker for more than 1 month prior to right heart catheterization can be continued on the calcium channel blocker.
boolean
C0042402 (UMLS CUI [1])
C0006684 (UMLS CUI [2])
Airway Obstruction; fev1
Item
patients with severe airway obstruction as defined by fev1/fvc of less than 35%
boolean
C0001883 (UMLS CUI [1])
C0588029 (UMLS CUI [2])
who class
Item
patients with world health organization (who) class iv status.
boolean
C0451584 (UMLS CUI [1])
pregnant; lactating
Item
patients who are pregnant or breast feeding
boolean
C2828358 (UMLS CUI [1,1])
C0549206 (UMLS CUI [1,2])
left ventricular dysfunction
Item
patients with significant left ventricular dysfunction with a left ventricular ejection fraction of less than 35%
boolean
C0242698 (UMLS CUI [1])
cardiac index; right atrial pressure
Item
cardiac index < 2.0 liters and/or right atrial pressure >15 mm hg
boolean
C0428776 (UMLS CUI [1])
C0456165 (UMLS CUI [2])
liver dysfunction
Item
significant liver dysfunction not due to sarcoidosis.
boolean
C0086565 (UMLS CUI [1])
compliance behavior limited comorbidity
Item
patients with severe other organ disease felt by investigators to impact on survival during the course of the study.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
walking
Item
patients unable to perform the 6 minute walk study
boolean
C0080331 (UMLS CUI [1])

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