ID

21475

Description

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

Keywords

Versions (1)
  1. 4/23/17 4/23/17 -
Uploaded on

April 23, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00273364

English

Eligibility Multiple Sclerosis NCT00273364

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. 1. age between18-55, inclusive.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. diagnosis of ms using revised mcdonald criteria of clinically definite ms (appendix i).
Description

Multiple Sclerosis Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0242801
3. an edss score of 2.0 to 6.0 (appendix ii).
Description

EDSS Score

Data type

boolean

Alias
UMLS CUI [1]
C0451246
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).
Description

Inflammatory disease treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1290884
UMLS CUI [1,2]
C0087111
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.
Description

Steroid therapy relapse

Data type

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0277556
exclusion criteria**
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
1. any illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive chemotherapy.
Description

Comorbidity affecting chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0392920
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.
Description

Prior malignancy

Data type

boolean

Alias
UMLS CUI [1]
C2735088
3. positive pregnancy test
Description

Pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0032976
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.
Description

Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
5. failure to willingly accept or comprehend irreversible sterility as a side effect of therapy
Description

Accepting sterility

Data type

boolean

Alias
UMLS CUI [1,1]
C1272684
UMLS CUI [1,2]
C0021359
6. fev1/fvc < 60% of predicted after bronchodilator therapy (if necessary)
Description

Fev1/fvc

Data type

boolean

Alias
UMLS CUI [1]
C0730560
7. dlco < 50% of predicted (for the transplant arm)
Description

DLCO

Data type

boolean

Alias
UMLS CUI [1]
C1516251
8. resting lvef < 50 %
Description

LVEF

Data type

boolean

Alias
UMLS CUI [1]
C0428772
9. bilirubin > 2.0 mg/dl
Description

Bilirubin

Data type

boolean

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

Creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
11. known hypersensitivity to mouse, rabbit, or e. coli derived proteins, or to iron compounds/medications
Description

Allergies

Data type

boolean

Alias
UMLS CUI [1]
C0020517
12. presence of metallic objects implanted in the body that would preclude the ability of the patient to safely have mri exams
Description

Implanted metallic objects

Data type

boolean

Alias
UMLS CUI [1]
C3693688
13. diagnosis of primary progressive ms
Description

Primary progressive ms

Data type

boolean

Alias
UMLS CUI [1]
C0751964
14. diagnosis of secondary progressive ms
Description

Secondary progressive ms

Data type

boolean

Alias
UMLS CUI [1]
C0751965
15. platelet count < 100,000/ul, wbc < 1,500 cells/mm3
Description

Platelets, WBC

Data type

boolean

Alias
UMLS CUI [1]
C0005821
UMLS CUI [2]
C0023508
16. psychiatric illness, mental deficiency or cognitive dysfunction making compliance with treatment or informed consent impossible
Description

Mental disorder affecting informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0021430
17. active infection except asymptomatic bacteriuria
Description

Active infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
18. use of natalizumab (tysabri) within the previous 6 months
Description

Natalizumab

Data type

boolean

Alias
UMLS CUI [1]
C1172734
19. use of fingolimod (gilenya) within the previous 3 months
Description

Fingolimod

Data type

boolean

Alias
UMLS CUI [1]
C1699926
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
Description

Teriflunomide

Data type

boolean

Alias
UMLS CUI [1]
C1718383
21. prior treatment with campath (alemtuzumab)
Description

Alemtuzumab

Data type

boolean

Alias
UMLS CUI [1]
C0383429
22. prior treatment with mitoxantrone
Description

Mitoxantrone

Data type

boolean

Alias
UMLS CUI [1]
C0026259
23. any hereditary neurological disease such as charcot-marie-tooth disease (cmt) or spinocerebellar ataxia (sca) are contraindications
Description

Hereditary neurological disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0019247
UMLS CUI [1,2]
C0027765
24. use of tecfidera within the previous 3 months
Description

Tecfidera

Data type

boolean

Alias
UMLS CUI [1]
C3556178
for patients who clearly have inflamatory disease, an exception can be made if agreed upon by study pi and at least two study neurologists.
Description

Inflammatory disease

Data type

boolean

Alias
UMLS CUI [1]
C1290884
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Similar models

Eligibility Multiple Sclerosis NCT00273364

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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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