Informatie:
Fout:
ID
21475
Beschrijving
Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized Study; ODM derived from: https://clinicaltrials.gov/show/NCT00273364
Link
https://clinicaltrials.gov/show/NCT00273364
Trefwoorden
Versies (1)
- 23-04-17 23-04-17 -
Geüploaded op
23 april 2017
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Eligibility Multiple Sclerosis NCT00273364
Eligibility Multiple Sclerosis NCT00273364
- StudyEvent: Eligibility
Similar models
Eligibility Multiple Sclerosis NCT00273364
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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])
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])
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])
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])
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])
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])
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])
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])
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])