Multiple Sclerosis, Relapsing-Remitting
Item
1. definite ms as determined by the mcdonald criteria (ann neurol, july 2001) with a relapsing disease course.
boolean
C0751967 (UMLS CUI [1])
EDSS
Item
2. 2.edss 0.0 - 6.5 inclusive
boolean
C0451246 (UMLS CUI [1])
Age
Item
3. 18 to 55 years of age
boolean
C0001779 (UMLS CUI [1])
Gadolinium-Enhancing Lesion Quantity
Item
4. 1 or more t1 gadolinium-enhancing lesions but no more than 15 lesions
boolean
C1333400 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Informed Consent
Item
5. able and willing to sign and date an informed consent form
boolean
C0021430 (UMLS CUI [1])
glatiramer acetate | Mitoxantrone
Item
1. patients ever treated with glatiramer acetate or mitoxantrone.
boolean
C0289884 (UMLS CUI [1])
C0026259 (UMLS CUI [2])
Interferons | Immunoglobulins, Intravenous
Item
2. patients treated with interferons or iv immunoglobulins (iv ig) in the previous 4 weeks prior to screening visits.
boolean
C0021747 (UMLS CUI [1])
C0085297 (UMLS CUI [2])
Methotrexate | Azathioprine
Item
3. patients treated with methotrexate or azathioprine in the previous 6 months prior to screening visits.
boolean
C0025677 (UMLS CUI [1])
C0004482 (UMLS CUI [2])
Cyclophosphamide | Lymphatic Irradiation Total | cladribine injection | Anthraquinones | Anthracyclines | Radiotherapy to mediastinum
Item
4. patients ever treated with cyclophosphamide or total lymphoid irradiation (tli), or cladribine for injection or anthracenediones or anthracyclines, or prior mediastinal radiotherapy.
boolean
C0010583 (UMLS CUI [1])
C0024230 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
C2075283 (UMLS CUI [3])
C0003174 (UMLS CUI [4])
C0282564 (UMLS CUI [5])
C4049191 (UMLS CUI [6])
Intravenous steroids | Steroids Oral | MRI
Item
5. patients treated with intravenous or oral steroids within 28 days prior to initial mri.
boolean
C0563322 (UMLS CUI [1])
C0038317 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0024485 (UMLS CUI [3])
Pregnancy | Breast Feeding | Gender Pregnancy test negative | Gender Contraceptive methods
Item
6. female patients must be non-pregnant, non-lactating, have a negative screening pregnancy test, and must use contraceptive methods deemed reliable by the investigator.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Gender Contraceptive methods | Partner Contraceptive methods
Item
7. male patients and their partners must use contraceptive methods deemed reliable by the investigator
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0682323 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Left ventricular ejection fraction
Item
8. lvef < 50%
boolean
C0428772 (UMLS CUI [1])
Catheter Use of | Foley catheter Use of
Item
9. patients using catheters or foley catheters
boolean
C0085590 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0179804 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
Systemic disease Significant Interferes with research results | Amyotrophic Lateral Sclerosis | Cervical spondylosis with myelopathy | Syphilis | Arteritis | Cerebellar Diseases | Vitamin B 12 Deficiency | Folic Acid Deficiency | Lyme Disease | Tropical Spastic Paraparesis
Item
10. patients who have any other known significant systemic medical disease which may confound the evaluation of the study results such as: als, cervical spondylitic myelopathy, syphilis, arteritis, cerebellar syndrome (i.e., due to heredodegeneration), b12/folate deficiency, lyme disease, htlv 1-myelopathy
boolean
C0442893 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0683954 (UMLS CUI [1,4])
C0002736 (UMLS CUI [2])
C0158242 (UMLS CUI [3])
C0039128 (UMLS CUI [4])
C0003860 (UMLS CUI [5])
C0007760 (UMLS CUI [6])
C0042847 (UMLS CUI [7])
C0016412 (UMLS CUI [8])
C0024198 (UMLS CUI [9])
C0030481 (UMLS CUI [10])
Immunologic Deficiency Syndromes Exclude Mitoxantrone | Immunologic Deficiency Syndromes Exclude glatiramer acetate | Medical condition Excludes Mitoxantrone | Medical condition Excludes glatiramer acetate
Item
11. patients with immune deficiency or other medical condition that would preclude treatment with mitoxantrone or glatiramer acetate
boolean
C0021051 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0026259 (UMLS CUI [1,3])
C0021051 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0289884 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0026259 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0289884 (UMLS CUI [4,3])
Blood test abnormal
Item
12. abnormal screening blood tests exceeding any of the limits defined below:
boolean
C0854146 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased | White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement | Creatinine measurement, serum | Prothrombin time increased
Item
alanine transaminase (alt) - twice the upper limit of normal aspartate transaminase (ast) - twice the upper limit of normal total white blood cell count < 2.3 x 103/ul baseline neutrophil counts of < 1.5 x103/ul platelet count < 80 x 103/ul creatinine >1.5 mg/dl prothrombin time greater than 150% upper limit of normal
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0200633 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C0151872 (UMLS CUI [7])
Medical condition Study Subject Participation Status Exclusion
Item
13. patients with any medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the investigator.
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])