Multiple Sclerosis, Relapsing-Remitting | Secondary Progressive Multiple Sclerosis Associated with Relapses | MRI scan Consistent with Multiple Sclerosis
Item
1. patients with documented multiple sclerosis relapsing remitting or secondary progressive with relapses, according to mcdonald's criteria, and an mri scan consistent with ms according to fazekas criteria
boolean
C0751967 (UMLS CUI [1])
C0751965 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0035020 (UMLS CUI [2,3])
C0024485 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C0026769 (UMLS CUI [3,3])
Relapse Quantity
Item
2. patients with at least 1 relapse in the last 12 months
boolean
C0035020 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
EDSS
Item
3. patients with edss score in the range of 0 to 5.5 at the baseline visit
boolean
C0451246 (UMLS CUI [1])
Age
Item
4. patients of both genders, age >18 years and < 60 years
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
5. women of child bearing potential, (who have a negative pregnancy test) must agree to use methods of medically acceptable forms of contraception during the study.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Protocol Compliance
Item
6. be able and willing to comply with study visits and procedures per protocol.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
7. understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed.
boolean
C0021430 (UMLS CUI [1])
At risk Illness Severe | At risk Death
Item
no populations at risk of severe illness or death will be included in this study
boolean
C1444641 (UMLS CUI [1,1])
C0221423 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C1444641 (UMLS CUI [2,1])
C0011065 (UMLS CUI [2,2])
Life Expectancy
Item
1. life expectancy < 6 months.
boolean
C0023671 (UMLS CUI [1])
Malignant Neoplasms Free of Duration | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
2. patient is < 5 years free of malignancy, except treated basal cell skin cancer or cervical carcinoma in situ.
boolean
C0006826 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Cardiac problem New York Heart Association Classification | Congestive heart failure | Myocardial Infarction
Item
3. patient with grade iii/iv cardiac problems as defined by the new york heart association criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
boolean
C0262402 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
Medical condition Severe Uncontrolled | Medical condition Uncontrolled
Item
4. patients with severe and/or uncontrolled medical condition.
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
HIV Infection
Item
5. patient has a known diagnosis of human immunodeficiency virus (hiv) infection.
boolean
C0019693 (UMLS CUI [1])
Anemia | Hemoglobin measurement | Gender
Item
6. anaemia (hb <10 g/dl for females, <11 g/dl for males)
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Parasitic infection | Anthelmintics
Item
7. prior or present evidence of parasitic infection; prior treatment with anti-helminthic drugs
boolean
C0747256 (UMLS CUI [1])
C0003158 (UMLS CUI [2])
Illness Serious Interferes with Treatment completion | Serious mental illness Interferes with Treatment completion
Item
8. patient with serious medical or psychiatric illness that could potentially interfere with the completion of the study treatment according to this protocol
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0580352 (UMLS CUI [1,4])
C3841614 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0580352 (UMLS CUI [2,3])
Poor compliance Interferes with Protocol Compliance | Substance Use Disorders Interfere with Protocol Compliance | Alcohol intake above recommended sensible limits Interferes with Protocol Compliance
Item
9. history of poor compliance or history of drug/alcohol abuse, or excessive alcohol consumption that would interfere with the ability to comply with the study protocol,
boolean
C0032646 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0038586 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0560219 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
Severe asthma | Severe allergy | Autoimmune Disease Severe | Condition Study Subject Participation Status Unfavorable | Laboratory test result abnormal
Item
10. severe asthma, allergy, other autoimmune disease or any condition that the physician judges could be detrimental to subjects participating in this study; including deviations deemed clinically important from normal clinical laboratory
boolean
C0581126 (UMLS CUI [1])
C2945656 (UMLS CUI [2])
C0004364 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0348080 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C3640815 (UMLS CUI [4,3])
C0438215 (UMLS CUI [5])
Prior Therapy
Item
previous treatment
boolean
C1514463 (UMLS CUI [1])
Interferon | Glatiramer acetate | Immunosuppressive Agents
Item
1. treatment with interferon or glatiramer acetate or immunosuppressive drugs within 26 weeks prior to baseline
boolean
C3652465 (UMLS CUI [1])
C0289884 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
Bone Marrow Transplantation | Lymphatic Irradiation Total | Monoclonal Antibodies | Umbilical Cord Blood Stem Cell | Other Coding
Item
2. treatment with bone marrow transplantation, total lymphoid irradiation, monoclonal antibodies, umbilical cord stem cells, aimspro at any time prior to baseline
boolean
C0005961 (UMLS CUI [1])
C0024230 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
C0003250 (UMLS CUI [3])
C1710528 (UMLS CUI [4])
C3846158 (UMLS CUI [5])
Adrenal Cortex Hormones | Corticotropin
Item
3. treatment with corticosteroids or acth within 4 weeks prior to baseline
boolean
C0001617 (UMLS CUI [1])
C0001655 (UMLS CUI [2])
Investigational New Drugs
Item
4. treatment with any investigational agent within 12 weeks prior to baseline
boolean
C0013230 (UMLS CUI [1])