ID

23196

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00377455

Nyckelord

  1. 2017-06-27 2017-06-27 -
Uppladdad den

27 juni 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Systemic Scleroderma NCT00377455

Eligibility Systemic Scleroderma NCT00377455

Inclusion Criteria
Beskrivning

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)
Beskrivning

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

Datatyp

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
Beskrivning

Catheterization of right heart

Datatyp

boolean

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

Mean pulmonary arterial pressure Resting Normal

Datatyp

boolean

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

Mean pulmonary arterial pressure Exercise

Datatyp

boolean

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

Wedge Pressure

Datatyp

boolean

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

Eligibility Criteria Participation Clinical Trial Specified

Datatyp

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
Beskrivning

Carbon Monoxide Diffusing Capability Test | Forced vital capacity

Datatyp

boolean

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

Ratio FVC DLCO

Datatyp

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
Beskrivning

Pulmonary artery systolic pressure Resting

Datatyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
established resting pulmonary hypertension
Beskrivning

Pulmonary Hypertension Resting

Datatyp

boolean

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

Congestive heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0018802
diastolic dysfunction
Beskrivning

Diastolic dysfunction

Datatyp

boolean

Alias
UMLS CUI [1]
C0520863
pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

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

Walking Unable | Exercise Unable

Datatyp

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
Beskrivning

Liver disease Severe

Datatyp

boolean

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

Similar models

Eligibility Systemic Scleroderma NCT00377455

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial