ID

30942

Descripción

Oral Corticotherapy in Megadoses to Treat Multiple Sclerosis During Relapse; ODM derived from: https://clinicaltrials.gov/show/NCT00753792

Link

https://clinicaltrials.gov/show/NCT00753792

Palabras clave

Versiones (1)
  1. 5/7/18 5/7/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

5 de julio de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00753792

Inglés

Eligibility Multiple Sclerosis NCT00753792

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Multiple Sclerosis, Relapsing-Remitting

Tipo de datos

boolean

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

EDSS | Status pre- Relapse

Tipo de datos

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.
Descripción

Symptom Onset Post Stability Previous

Tipo de datos

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.
Descripción

Symptom Onset Recently

Tipo de datos

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.
Descripción

Able to communicate Investigator | Protocol Compliance

Tipo de datos

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).
Descripción

Immunomodulation Interferon-beta | Absence Immunomodulation Interferon-beta

Tipo de datos

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.
Descripción

Ingestion Pharmaceutical Preparations Able | Ingestion Pharmaceutical Preparations Willing

Tipo de datos

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
Descripción

Exclusion Criteria

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

First episode Neurologic inflammatory | Relapse

Tipo de datos

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.
Descripción

Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Primary Progressive

Tipo de datos

boolean

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

Symptoms Duration

Tipo de datos

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.
Descripción

Adrenal Cortex Hormones

Tipo de datos

boolean

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

Immunosuppressive Agents | Azathioprine | Mitoxantrone | Cyclophosphamide

Tipo de datos

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.
Descripción

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

Tipo de datos

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.
Descripción

Illness | Medical contraindication Adrenal Cortex Hormones

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

MRI Periodic Unable | Patient uncooperative | Patient need for Anesthesia

Tipo de datos

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.
Descripción

Lactose Intolerance

Tipo de datos

boolean

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

Contrast media allergy

Tipo de datos

boolean

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

Chronic Kidney Diseases

Tipo de datos

boolean

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

natalizumab

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1172734
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Similar models

Eligibility Multiple Sclerosis NCT00753792

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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