ID

13119

Beskrivning

Stem Cell Support in Patients With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00278551

Länk

https://clinicaltrials.gov/show/NCT00278551

Nyckelord

Versioner (1)
  1. 2016-01-18 2016-01-18 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

18 januari 2016

DOI

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Creative Commons BY-NC 3.0
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Eligibility RHEUMATOID ARTHRITIS NCT00278551

Engelsk

Eligibility RHEUMATOID ARTHRITIS NCT00278551

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. physiologic age < 60 years old or >18 years old.
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. an established clinical diagnosis of rheumatoid arthritis by american college of rheumatology criteria, and a positive rheumatoid factor will be required.
Beskrivning

rheumatoid arthritis

Datatyp

boolean

Alias
UMLS CUI [1]
C0003873
3. patients must have failed two disease-modifying agents, such as methotrexate, plaquenil, gold, azathioprine, asulfidine or d-penicillamine.
Beskrivning

antirheumatic agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0003191
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."
Beskrivning

activity of rheumatoid arthritis

Datatyp

boolean

Alias
UMLS CUI [1]
C0003873
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.
Beskrivning

PBSC

Datatyp

boolean

Alias
UMLS CUI [1]
C1518999
6. ability to give informed consent
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
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
Beskrivning

juvenile rheumatoid arthritis

Datatyp

boolean

Alias
UMLS CUI [1]
C0311221
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. hiv positive
Beskrivning

HIV

Datatyp

boolean

Alias
UMLS CUI [1]
C0019682
2. history of coronary artery disease, or congestive heart failure.
Beskrivning

Cardiac disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
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
Beskrivning

comorbidity

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
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.
Beskrivning

prior malignancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
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.
Beskrivning

pregnancy, contraception

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0700589
6. psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible
Beskrivning

psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
7. fev1/fvc < 75% of predicted, dlco < 50% of predicted.
Beskrivning

lung function

Datatyp

boolean

Alias
UMLS CUI [1]
C0024119
8. resting lvef < 45 %
Beskrivning

LVEF

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
9. bilirubin > 2.0 mg/dl, transferase (ast) > 2x upper limit of normal
Beskrivning

bilirubin, AST

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
10. serum creatinine > 2.0 mg/dl
Beskrivning

creatinine

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
11. platelet count less than 100,000/ul, anc less than 1000/ul
Beskrivning

platelet count, ANC

Datatyp

boolean

Alias
UMLS CUI [1]
C0005821
UMLS CUI [2]
C0948762
12. history of allergy to eggs or murine proteins
Beskrivning

Allergy to eggs or murine proteins

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013700
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1699668
13. known hypersensitivity to e. coli derived proteins
Beskrivning

hypersensitivity to e. coli derived proteins

Datatyp

boolean

Alias
UMLS CUI [1]
C0020517
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Similar models

Eligibility RHEUMATOID ARTHRITIS NCT00278551

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])
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])
hypersensitivity to e. coli derived proteins
Item
13. known hypersensitivity to e. coli derived proteins
boolean
C0020517 (UMLS CUI [1])
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