Informations:
Erreur:
ID
13119
Description
Stem Cell Support in Patients With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00278551
Lien
https://clinicaltrials.gov/show/NCT00278551
Mots-clés
Versions (1)
- 18/01/2016 18/01/2016 -
Détendeur de droits
CC BY-NC 3.0
Téléchargé le
18 janvier 2016
DOI
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Licence
Creative Commons BY-NC 3.0
Modèle Commentaires :
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Eligibility RHEUMATOID ARTHRITIS NCT00278551
Eligibility RHEUMATOID ARTHRITIS NCT00278551
- StudyEvent: Eligibility
Similar models
Eligibility RHEUMATOID ARTHRITIS NCT00278551
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
age
Item
1. physiologic age < 60 years old or >18 years old.
boolean
C0001779 (UMLS CUI [1])
rheumatoid arthritis
Item
2. an established clinical diagnosis of rheumatoid arthritis by american college of rheumatology criteria, and a positive rheumatoid factor will be required.
boolean
C0003873 (UMLS CUI [1])
antirheumatic agents
Item
3. patients must have failed two disease-modifying agents, such as methotrexate, plaquenil, gold, azathioprine, asulfidine or d-penicillamine.
boolean
C0003191 (UMLS CUI [1])
activity of rheumatoid arthritis
Item
4. patients must have six (6) swollen joints from active ra and either thirty (30) or greater involved joints (swelling, tenderness, deformity, pain on motion, or decreased motion), or have answered less than 75 percent of health assessment questionnaire (haq) questions "without any difficulty."
boolean
C0003873 (UMLS CUI [1])
PBSC
Item
5. a harvest of pbsc greater than 1.4 x 106 cd34+ cells /kg after cd34+ selection will be necessary for the patient to proceed to transplant.
boolean
C1518999 (UMLS CUI [1])
informed consent
Item
6. ability to give informed consent
boolean
C0021430 (UMLS CUI [1])
juvenile rheumatoid arthritis
Item
7. patients with juvenile rheumatoid arthritis (jra) will be candidates if disease onset is polyarthritic or systemic and they have at least 6 swollen joints and have failed corticosteroids and two disease-modifying drugs
boolean
C0311221 (UMLS CUI [1])
HIV
Item
1. hiv positive
boolean
C0019682 (UMLS CUI [1])
Cardiac disease
Item
2. history of coronary artery disease, or congestive heart failure.
boolean
C0018799 (UMLS CUI [1])
comorbidity
Item
3. uncontrolled diabetes mellitus, or any other illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive chemoradiotherapy
boolean
C0009488 (UMLS CUI [1])
prior malignancy
Item
4. prior history of malignancy except localized basal cell or squamous skin cancer. other malignancies for which the patient is judged to be cured by local surgical therapy, such as head and neck cancer, or stage i breast cancer will be considered on an individual basis.
boolean
C0006826 (UMLS CUI [1])
pregnancy, contraception
Item
5. positive pregnancy test, inability or unwillingness to pursue effective means of birth control, failure to willingly accept or comprehend irreversible sterility as a side effect of therapy.
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0700589 (UMLS CUI [2])
psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible
Item
6. psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
lung function
Item
7. fev1/fvc < 75% of predicted, dlco < 50% of predicted.
boolean
C0024119 (UMLS CUI [1])
LVEF
Item
8. resting lvef < 45 %
boolean
C0428772 (UMLS CUI [1])
bilirubin, AST
Item
9. bilirubin > 2.0 mg/dl, transferase (ast) > 2x upper limit of normal
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201899 (UMLS CUI [2])
creatinine
Item
10. serum creatinine > 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
platelet count, ANC
Item
11. platelet count less than 100,000/ul, anc less than 1000/ul
boolean
C0005821 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0948762 (UMLS CUI [2])
Allergy to eggs or murine proteins
Item
12. history of allergy to eggs or murine proteins
boolean
C0020517 (UMLS CUI [1,1])
C0013700 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1699668 (UMLS CUI [2,2])
C0013700 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1699668 (UMLS CUI [2,2])
hypersensitivity to e. coli derived proteins
Item
13. known hypersensitivity to e. coli derived proteins
boolean
C0020517 (UMLS CUI [1])