ID

23033

Beschrijving

Inhaled Iloprost for Sarcoidosis-associated Pulmonary Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00403650

Link

https://clinicaltrials.gov/show/NCT00403650

Trefwoorden

  1. 20-06-17 20-06-17 -
Geüploaded op

20 juni 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Sarcoidosis NCT00403650

Eligibility Sarcoidosis NCT00403650

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with known sarcoidosis 17
Beschrijving

Sarcoidosis

Datatype

boolean

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

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients with documented pulmonary hypertension with a pa mean > 25 mm as measured by cardiac catheterization within six months of entry into the study
Beschrijving

Pulmonary Hypertension | cardiac catheterization - mean pulmonary artery pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0020542
UMLS CUI [2]
C2008312
patients with dyspnea
Beschrijving

Dyspnea

Datatype

boolean

Alias
UMLS CUI [1]
C0013404
six minute walk distance of between 100 to 500 meters
Beschrijving

6-minute walk test Distance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0430515
UMLS CUI [1,2]
C0012751
patients on stable immunotherapy for their sarcoidosis, including prednisone, methotrexate, azathioprine, hydroxychloroquine, cyclophosphamide, thalidomide, and/or infliximab
Beschrijving

Immunotherapy Stable Sarcoidosis | Prednisone | Methotrexate | Azathioprine | Hydroxychloroquine | Cyclophosphamide | Thalidomide | infliximab

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0036202
UMLS CUI [2]
C0032952
UMLS CUI [3]
C0025677
UMLS CUI [4]
C0004482
UMLS CUI [5]
C0020336
UMLS CUI [6]
C0010583
UMLS CUI [7]
C0039736
UMLS CUI [8]
C0666743
patients able to provide written consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients on pulmonary vasodilator drugs (flolan, remodulin, bosentan, sildenafil) in 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)
Beschrijving

pulmonary vasodilators | Flolan | Remodulin | bosentan | sildenafil | Calcium Channel Blockers Dose Stable | Catheterization of right heart

Datatype

boolean

Alias
UMLS CUI [1]
C2143186
UMLS CUI [2]
C0376357
UMLS CUI [3]
C1101501
UMLS CUI [4]
C0252643
UMLS CUI [5]
C0529793
UMLS CUI [6,1]
C0006684
UMLS CUI [6,2]
C0178602
UMLS CUI [6,3]
C0205360
UMLS CUI [7]
C0189896
patients with severe airway obstruction as defined by fev1/fvc of less than 35%
Beschrijving

Airway Obstruction Severe | FEV1/FVC percent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001883
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0730560
patients with world health organization (who) class iv status
Beschrijving

World Health Organization Class Functional

Datatype

boolean

Alias
UMLS CUI [1,1]
C0043237
UMLS CUI [1,2]
C0456387
UMLS CUI [1,3]
C0205245
patients who are pregnant or breast feeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with significant left ventricular dysfunction with a left ventricular ejection fraction of less than 35%
Beschrijving

Ventricular Dysfunction, Left | Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0242698
UMLS CUI [2]
C0428772
significant liver dysfunction not due to sarcoidosis
Beschrijving

Liver Dysfunction Independent of Sarcoidosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0332291
UMLS CUI [1,3]
C0036202
patients with severe other organ disease felt by investigators to impact survival during the course of the study
Beschrijving

Organ Disease Severe Impact Survival

Datatype

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0205082
UMLS CUI [1,4]
C4049986
UMLS CUI [1,5]
C0038952
patients unable to perform the 6 inhalation treatments required for therapy
Beschrijving

Inhalation Therapy Quantity Perform Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021459
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0884358
UMLS CUI [1,4]
C1299582
patients with < 90 mm hg systolic systemic blood pressure will be excluded
Beschrijving

Systolic Pressure Systemic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0205373

Similar models

Eligibility Sarcoidosis NCT00403650

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Sarcoidosis
Item
patients with known sarcoidosis 17
boolean
C0036202 (UMLS CUI [1])
Age
Item
age 18 or greater
boolean
C0001779 (UMLS CUI [1])
Pulmonary Hypertension | cardiac catheterization - mean pulmonary artery pressure
Item
patients with documented pulmonary hypertension with a pa mean > 25 mm as measured by cardiac catheterization within six months of entry into the study
boolean
C0020542 (UMLS CUI [1])
C2008312 (UMLS CUI [2])
Dyspnea
Item
patients with dyspnea
boolean
C0013404 (UMLS CUI [1])
6-minute walk test Distance
Item
six minute walk distance of between 100 to 500 meters
boolean
C0430515 (UMLS CUI [1,1])
C0012751 (UMLS CUI [1,2])
Immunotherapy Stable Sarcoidosis | Prednisone | Methotrexate | Azathioprine | Hydroxychloroquine | Cyclophosphamide | Thalidomide | infliximab
Item
patients on stable immunotherapy for their sarcoidosis, including prednisone, methotrexate, azathioprine, hydroxychloroquine, cyclophosphamide, thalidomide, and/or infliximab
boolean
C0021083 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0036202 (UMLS CUI [1,3])
C0032952 (UMLS CUI [2])
C0025677 (UMLS CUI [3])
C0004482 (UMLS CUI [4])
C0020336 (UMLS CUI [5])
C0010583 (UMLS CUI [6])
C0039736 (UMLS CUI [7])
C0666743 (UMLS CUI [8])
Informed Consent
Item
patients able to provide written consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pulmonary vasodilators | Flolan | Remodulin | bosentan | sildenafil | Calcium Channel Blockers Dose Stable | Catheterization of right heart
Item
patients on pulmonary vasodilator drugs (flolan, remodulin, bosentan, sildenafil) in 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
C2143186 (UMLS CUI [1])
C0376357 (UMLS CUI [2])
C1101501 (UMLS CUI [3])
C0252643 (UMLS CUI [4])
C0529793 (UMLS CUI [5])
C0006684 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
C0189896 (UMLS CUI [7])
Airway Obstruction Severe | FEV1/FVC percent
Item
patients with severe airway obstruction as defined by fev1/fvc of less than 35%
boolean
C0001883 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0730560 (UMLS CUI [2])
World Health Organization Class Functional
Item
patients with world health organization (who) class iv status
boolean
C0043237 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C0205245 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
patients who are pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Ventricular Dysfunction, Left | Left ventricular ejection fraction
Item
patients with significant left ventricular dysfunction with a left ventricular ejection fraction of less than 35%
boolean
C0242698 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Liver Dysfunction Independent of Sarcoidosis
Item
significant liver dysfunction not due to sarcoidosis
boolean
C0086565 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C0036202 (UMLS CUI [1,3])
Organ Disease Severe Impact Survival
Item
patients with severe other organ disease felt by investigators to impact survival during the course of the study
boolean
C0178784 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C4049986 (UMLS CUI [1,4])
C0038952 (UMLS CUI [1,5])
Inhalation Therapy Quantity Perform Unable
Item
patients unable to perform the 6 inhalation treatments required for therapy
boolean
C0021459 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Systolic Pressure Systemic
Item
patients with < 90 mm hg systolic systemic blood pressure will be excluded
boolean
C0871470 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])

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