Eligibility Multiple Sclerosis NCT00753792

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. to have been diagnosed ms remittent recurrent according to mc donald 20052 criteria.
Description

Multiple Sclerosis, Relapsing-Remitting

Data type

boolean

Alias
UMLS CUI [1]
C0751967
2. to have an edss between 0 and 5 before the relapse.
Description

EDSS | Status pre- Relapse

Data type

boolean

Alias
UMLS CUI [1]
C0451246
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0035020
3. the symptoms have begun after at least one month of previous stability.
Description

Symptom Onset Post Stability Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C4086878
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0205156
4. the symptoms have started maximum 15 days before the inclusion.
Description

Symptom Onset Recently

Data type

boolean

Alias
UMLS CUI [1,1]
C4086878
UMLS CUI [1,2]
C0332185
5. the patient is capable of having an adequate communication with the investigator and to carry out with the clinical trial requisites.
Description

Able to communicate Investigator | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C2364293
UMLS CUI [1,2]
C0035173
UMLS CUI [2]
C0525058
6. to be or not to be with allowed immunomodulatory therapy (ifn-b /ag).
Description

Immunomodulation Interferon-beta | Absence Immunomodulation Interferon-beta

Data type

boolean

Alias
UMLS CUI [1,1]
C1963758
UMLS CUI [1,2]
C0015980
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1963758
UMLS CUI [2,3]
C0015980
7. to be capable and to be willing to ingest the medication.
Description

Ingestion Pharmaceutical Preparations Able | Ingestion Pharmaceutical Preparations Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0232478
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C0232478
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0600109
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. first inflammatory neurological episode (relapse).
Description

First episode Neurologic inflammatory | Relapse

Data type

boolean

Alias
UMLS CUI [1,1]
C0439615
UMLS CUI [1,2]
C0205494
UMLS CUI [1,3]
C0333348
UMLS CUI [2]
C0035020
2. multiple sclerosis secondary progressive or primary progressive.
Description

Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Primary Progressive

Data type

boolean

Alias
UMLS CUI [1]
C0751965
UMLS CUI [2]
C0751964
3. the symptoms have gone on for less than 24 hours.
Description

Symptoms Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0449238
4. to be in treatment or have been treated with corticoids during the three months before.
Description

Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1]
C0001617
5. patients in treatment with immunosuppressors (azathioprine, mitoxantrone, ciclofosfamide...)
Description

Immunosuppressive Agents | Azathioprine | Mitoxantrone | Cyclophosphamide

Data type

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0004482
UMLS CUI [3]
C0026259
UMLS CUI [4]
C0010583
6. pregnancy or breastfeeding or women in fertile age who don't use contraceptives measurements.
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332268
7. illnesses with contraindication treatment with corticoids.
Description

Illness | Medical contraindication Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1]
C0221423
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0001617
8. antecedents of serious adverse effects or hypersensitive to related study medication.
Description

Adverse effects Serious Investigational New Drugs Related | Hypersensitivity Investigational New Drugs Related

Data type

boolean

Alias
UMLS CUI [1,1]
C0879626
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0013230
UMLS CUI [1,4]
C0439849
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0439849
9. patients who wouldn´t be able to perform periodic rmn explorations, patients who are not collaborative or who need anesthesia.
Description

MRI Periodic Unable | Patient uncooperative | Patient need for Anesthesia

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0332182
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0747308
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0002903
10. patients with intolerance to lactose.
Description

Lactose Intolerance

Data type

boolean

Alias
UMLS CUI [1]
C0022951
11. patients with allergy to contrast used in rmn.
Description

Contrast media allergy

Data type

boolean

Alias
UMLS CUI [1]
C0570562
12. patients with chronic kidney disease.
Description

Chronic Kidney Diseases

Data type

boolean

Alias
UMLS CUI [1]
C1561643
13. patients in treatment with natalizumab.
Description

natalizumab

Data type

boolean

Alias
UMLS CUI [1]
C1172734

Similar models

Eligibility Multiple Sclerosis NCT00753792

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis, Relapsing-Remitting
Item
1. to have been diagnosed ms remittent recurrent according to mc donald 20052 criteria.
boolean
C0751967 (UMLS CUI [1])
EDSS | Status pre- Relapse
Item
2. to have an edss between 0 and 5 before the relapse.
boolean
C0451246 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0035020 (UMLS CUI [2,2])
Symptom Onset Post Stability Previous
Item
3. the symptoms have begun after at least one month of previous stability.
boolean
C4086878 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0205156 (UMLS CUI [1,4])
Symptom Onset Recently
Item
4. the symptoms have started maximum 15 days before the inclusion.
boolean
C4086878 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Able to communicate Investigator | Protocol Compliance
Item
5. the patient is capable of having an adequate communication with the investigator and to carry out with the clinical trial requisites.
boolean
C2364293 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Immunomodulation Interferon-beta | Absence Immunomodulation Interferon-beta
Item
6. to be or not to be with allowed immunomodulatory therapy (ifn-b /ag).
boolean
C1963758 (UMLS CUI [1,1])
C0015980 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C1963758 (UMLS CUI [2,2])
C0015980 (UMLS CUI [2,3])
Ingestion Pharmaceutical Preparations Able | Ingestion Pharmaceutical Preparations Willing
Item
7. to be capable and to be willing to ingest the medication.
boolean
C0232478 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0232478 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
First episode Neurologic inflammatory | Relapse
Item
1. first inflammatory neurological episode (relapse).
boolean
C0439615 (UMLS CUI [1,1])
C0205494 (UMLS CUI [1,2])
C0333348 (UMLS CUI [1,3])
C0035020 (UMLS CUI [2])
Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Primary Progressive
Item
2. multiple sclerosis secondary progressive or primary progressive.
boolean
C0751965 (UMLS CUI [1])
C0751964 (UMLS CUI [2])
Symptoms Duration
Item
3. the symptoms have gone on for less than 24 hours.
boolean
C1457887 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Adrenal Cortex Hormones
Item
4. to be in treatment or have been treated with corticoids during the three months before.
boolean
C0001617 (UMLS CUI [1])
Immunosuppressive Agents | Azathioprine | Mitoxantrone | Cyclophosphamide
Item
5. patients in treatment with immunosuppressors (azathioprine, mitoxantrone, ciclofosfamide...)
boolean
C0021081 (UMLS CUI [1])
C0004482 (UMLS CUI [2])
C0026259 (UMLS CUI [3])
C0010583 (UMLS CUI [4])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking
Item
6. pregnancy or breastfeeding or women in fertile age who don't use contraceptives measurements.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
Illness | Medical contraindication Adrenal Cortex Hormones
Item
7. illnesses with contraindication treatment with corticoids.
boolean
C0221423 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
Adverse effects Serious Investigational New Drugs Related | Hypersensitivity Investigational New Drugs Related
Item
8. antecedents of serious adverse effects or hypersensitive to related study medication.
boolean
C0879626 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
MRI Periodic Unable | Patient uncooperative | Patient need for Anesthesia
Item
9. patients who wouldn´t be able to perform periodic rmn explorations, patients who are not collaborative or who need anesthesia.
boolean
C0024485 (UMLS CUI [1,1])
C0332182 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0747308 (UMLS CUI [2])
C0686904 (UMLS CUI [3,1])
C0002903 (UMLS CUI [3,2])
Lactose Intolerance
Item
10. patients with intolerance to lactose.
boolean
C0022951 (UMLS CUI [1])
Contrast media allergy
Item
11. patients with allergy to contrast used in rmn.
boolean
C0570562 (UMLS CUI [1])
Chronic Kidney Diseases
Item
12. patients with chronic kidney disease.
boolean
C1561643 (UMLS CUI [1])
natalizumab
Item
13. patients in treatment with natalizumab.
boolean
C1172734 (UMLS CUI [1])