Eligibility Multiple Sclerosis NCT00273364

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StudyEvent: Eligibility
1. Eligibility Multiple Sclerosis NCT00273364

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Age

Item

1. 1. age between18-55, inclusive.

boolean

C0001779 (UMLS CUI [1])

Multiple Sclerosis Criteria

Item

2. diagnosis of ms using revised mcdonald criteria of clinically definite ms (appendix i).

boolean

C0026769 (UMLS CUI [1,1])
C0242801 (UMLS CUI [1,2])

EDSS Score

Item

3. an edss score of 2.0 to 6.0 (appendix ii).

boolean

C0451246 (UMLS CUI [1])

Inflammatory disease treatment

Item

4. inflammatory disease despite treatment with standard disease modifying therapy including at least 6 months of interferon or copaxone. inflammatory disease is defined based on both mri (gadolinium enhancing lesions) and clinical activity (acute relapses *treated with iv or oral high dose corticosteroids and prescribed by a neurologist). minimum disease activity required for failure is defined as: a) two or more *steroid treated clinical relapses with documented new objective signs on neurological examination documented by a neurologist within the year prior to the study, or b) one *steroid treated clinical relapse within the year prior to study and evidence on mri of active inflammation (i.e., gadolinium enhancement) within the last 12 months on an occasion separate from the clinical relapse (3 months before or after the clinical relapse).

boolean

C1290884 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])

Steroid therapy relapse

Item

a steroid treated relapse will include a relapse that was severe enough to justify treatment but due to patient intolerance of steroids, or a history of non-response to steroids, they were offered but not used.

boolean

C0149783 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])

Exclusion Criteria

Item

exclusion criteria**

boolean

C0680251 (UMLS CUI [1])

Comorbidity affecting chemotherapy

Item

1. any illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive chemotherapy.

boolean

C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])

Prior malignancy

Item

2. prior history of malignancy except localized basal cell, squamous skin cancer or carcinoma in situ of the cervix. other malignancies for which the patient is judged to be cured, such as head and neck cancer, or breast cancer will be considered on an individual basis.

boolean

C2735088 (UMLS CUI [1])

Pregnancy test

Item

3. positive pregnancy test

boolean

C0032976 (UMLS CUI [1])

Contraceptive methods

Item

4. inability or unwillingness to pursue effective means of birth control from the time of evaluation for eligibility until 6 months posttransplant (if on transplant) or until appropriate for non-transplant treatment (if on control arm). effective birth control is defined as 1) abstinence defined as refraining from all acts of vaginal intercourse; 2) consistent use of birth control pills; 3) injectable birth control methods (depo-provera, norplant); 4) tubal sterilization or male partner who has undergone vasectomy; 5) placement of an intrauterine device (iud); or 6) use, with every act of intercourse, of diaphragm with contraceptive jelly and/or condoms with contraceptive foam.

boolean

C0700589 (UMLS CUI [1])

Accepting sterility

Item

5. failure to willingly accept or comprehend irreversible sterility as a side effect of therapy

boolean

C1272684 (UMLS CUI [1,1])
C0021359 (UMLS CUI [1,2])

Fev1/fvc

Item

6. fev1/fvc < 60% of predicted after bronchodilator therapy (if necessary)

boolean

C0730560 (UMLS CUI [1])

DLCO

Item

7. dlco < 50% of predicted (for the transplant arm)

boolean

C1516251 (UMLS CUI [1])

LVEF

Item

8. resting lvef < 50 %

boolean

C0428772 (UMLS CUI [1])

Bilirubin

Item

9. bilirubin > 2.0 mg/dl

boolean

C1278039 (UMLS CUI [1])

Creatinine

Item

10. serum creatinine > 2.0 mg/dl

boolean

C0201976 (UMLS CUI [1])

Allergies

Item

11. known hypersensitivity to mouse, rabbit, or e. coli derived proteins, or to iron compounds/medications

boolean

C0020517 (UMLS CUI [1])

Implanted metallic objects

Item

12. presence of metallic objects implanted in the body that would preclude the ability of the patient to safely have mri exams

boolean

C3693688 (UMLS CUI [1])

Primary progressive ms

Item

13. diagnosis of primary progressive ms

boolean

C0751964 (UMLS CUI [1])

Secondary progressive ms

Item

14. diagnosis of secondary progressive ms

boolean

C0751965 (UMLS CUI [1])

Platelets, WBC

Item

15. platelet count < 100,000/ul, wbc < 1,500 cells/mm3

boolean

C0005821 (UMLS CUI [1])
C0023508 (UMLS CUI [2])

Mental disorder affecting informed consent

Item

16. psychiatric illness, mental deficiency or cognitive dysfunction making compliance with treatment or informed consent impossible

boolean

C0004936 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])

Active infection

Item

17. active infection except asymptomatic bacteriuria

boolean

C0009450 (UMLS CUI [1])

Natalizumab

Item

18. use of natalizumab (tysabri) within the previous 6 months

boolean

C1172734 (UMLS CUI [1])

Fingolimod

Item

19. use of fingolimod (gilenya) within the previous 3 months

boolean

C1699926 (UMLS CUI [1])

Teriflunomide

Item

20. use of teriflunomide (aubagio) within the previous 2 years unless cleared from the body (plasma concentration < 0.02mcg/ml) following elimination from the body with cholestyramine 8g three times a day for 11 days

boolean

C1718383 (UMLS CUI [1])

Alemtuzumab

Item

21. prior treatment with campath (alemtuzumab)

boolean

C0383429 (UMLS CUI [1])

Mitoxantrone

Item

22. prior treatment with mitoxantrone

boolean

C0026259 (UMLS CUI [1])

Hereditary neurological disease

Item

23. any hereditary neurological disease such as charcot-marie-tooth disease (cmt) or spinocerebellar ataxia (sca) are contraindications

boolean

C0019247 (UMLS CUI [1,1])
C0027765 (UMLS CUI [1,2])

Tecfidera

Item

24. use of tecfidera within the previous 3 months

boolean

C3556178 (UMLS CUI [1])

Inflammatory disease

Item

for patients who clearly have inflamatory disease, an exception can be made if agreed upon by study pi and at least two study neurologists.

boolean

C1290884 (UMLS CUI [1])

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Eligibility Multiple Sclerosis NCT00273364