ID

23196

Description

Placebo Controlled Trial of Bosentan in Scleroderma Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00377455

Link

https://clinicaltrials.gov/show/NCT00377455

Keywords

  1. 6/27/17 6/27/17 -
Uploaded on

June 27, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Systemic Scleroderma NCT00377455

Eligibility Systemic Scleroderma NCT00377455

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ssc patients > 18 with nyha functional class i/ii symptoms, informed consent, and who are willing to participate in the pulmonary hypertension assessment and recognition of outcomes in scleroderma (pharos) long term study (georgetown irb 04-227)
Description

Systemic Scleroderma | Age | Symptoms New York Heart Association Classification | Informed Consent | Participation Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1]
C0036421
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C1275491
UMLS CUI [4]
C0021430
UMLS CUI [5,1]
C0679823
UMLS CUI [5,2]
C0008976
UMLS CUI [5,3]
C0205369
right heart catheterization with
Description

Catheterization of right heart

Data type

boolean

Alias
UMLS CUI [1]
C0189896
1. normal mean pulmonary arterial pressure (pap) at rest
Description

Mean pulmonary arterial pressure Resting Normal

Data type

boolean

Alias
UMLS CUI [1,1]
C3854605
UMLS CUI [1,2]
C0035253
UMLS CUI [1,3]
C0205307
2. mean pap > 30 with exercise
Description

Mean pulmonary arterial pressure Exercise

Data type

boolean

Alias
UMLS CUI [1,1]
C3854605
UMLS CUI [1,2]
C0015259
3. wedge pressure < 18
Description

Wedge Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0043091
entry criteria for participating in the exercise echocardiogram study (georegtown irb 03-363)
Description

Eligibility Criteria Participation Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0205369
1. diffusing capacity (dlco) <60 with a forced vital capacity (fvc) >60%, or
Description

Carbon Monoxide Diffusing Capability Test | Forced vital capacity

Data type

boolean

Alias
UMLS CUI [1]
C1516251
UMLS CUI [2]
C1287681
2. fvc/dlco > 1.6, or
Description

Ratio FVC DLCO

Data type

boolean

Alias
UMLS CUI [1,1]
C0456603
UMLS CUI [1,2]
C1287681
UMLS CUI [1,3]
C1516251
3. a resting pulmonary arterial systolic pressure (pasp)> 40mmhg
Description

Pulmonary artery systolic pressure Resting

Data type

boolean

Alias
UMLS CUI [1,1]
C0428643
UMLS CUI [1,2]
C0035253
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
established resting pulmonary hypertension
Description

Pulmonary Hypertension Resting

Data type

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0035253
congestive heart failure
Description

Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018802
diastolic dysfunction
Description

Diastolic dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0520863
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
inability to adequately walk/exercise
Description

Walking Unable | Exercise Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0080331
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0015259
UMLS CUI [2,2]
C1299582
severe liver disease
Description

Liver disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082

Similar models

Eligibility Systemic Scleroderma NCT00377455

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Systemic Scleroderma | Age | Symptoms New York Heart Association Classification | Informed Consent | Participation Clinical Trial Specified
Item
ssc patients > 18 with nyha functional class i/ii symptoms, informed consent, and who are willing to participate in the pulmonary hypertension assessment and recognition of outcomes in scleroderma (pharos) long term study (georgetown irb 04-227)
boolean
C0036421 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C1457887 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4])
C0679823 (UMLS CUI [5,1])
C0008976 (UMLS CUI [5,2])
C0205369 (UMLS CUI [5,3])
Catheterization of right heart
Item
right heart catheterization with
boolean
C0189896 (UMLS CUI [1])
Mean pulmonary arterial pressure Resting Normal
Item
1. normal mean pulmonary arterial pressure (pap) at rest
boolean
C3854605 (UMLS CUI [1,1])
C0035253 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
Mean pulmonary arterial pressure Exercise
Item
2. mean pap > 30 with exercise
boolean
C3854605 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
Wedge Pressure
Item
3. wedge pressure < 18
boolean
C0043091 (UMLS CUI [1])
Eligibility Criteria Participation Clinical Trial Specified
Item
entry criteria for participating in the exercise echocardiogram study (georegtown irb 03-363)
boolean
C1516637 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
Carbon Monoxide Diffusing Capability Test | Forced vital capacity
Item
1. diffusing capacity (dlco) <60 with a forced vital capacity (fvc) >60%, or
boolean
C1516251 (UMLS CUI [1])
C1287681 (UMLS CUI [2])
Ratio FVC DLCO
Item
2. fvc/dlco > 1.6, or
boolean
C0456603 (UMLS CUI [1,1])
C1287681 (UMLS CUI [1,2])
C1516251 (UMLS CUI [1,3])
Pulmonary artery systolic pressure Resting
Item
3. a resting pulmonary arterial systolic pressure (pasp)> 40mmhg
boolean
C0428643 (UMLS CUI [1,1])
C0035253 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pulmonary Hypertension Resting
Item
established resting pulmonary hypertension
boolean
C0020542 (UMLS CUI [1,1])
C0035253 (UMLS CUI [1,2])
Congestive heart failure
Item
congestive heart failure
boolean
C0018802 (UMLS CUI [1])
Diastolic dysfunction
Item
diastolic dysfunction
boolean
C0520863 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Walking Unable | Exercise Unable
Item
inability to adequately walk/exercise
boolean
C0080331 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0015259 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Liver disease Severe
Item
severe liver disease
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])

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