ID

18253

Descripción

Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients With Relapsing Multiple Sclerosis (MS); ODM derived from: https://clinicaltrials.gov/show/NCT00079495

Link

https://clinicaltrials.gov/show/NCT00079495

Palabras clave

Versiones (1)
  1. 26/10/16 26/10/16 -
Subido en

26 de octubre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00079495

Inglés

Eligibility Multiple Sclerosis NCT00079495

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, 18 to 55 years of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
diagnosed with relapsing multiple sclerosis, with at least one relapse in the last two years
Descripción

Multiple sclerosis relapse | Relapse Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0856120
UMLS CUI [2,1]
C0035020
UMLS CUI [2,2]
C1265611
females must not plan on becoming pregnant
Descripción

Pregnancy, Planned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032992
females must either be post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control and willing to continue birth control until 30 days after the last dose of study drug
Descripción

Gender | Postmenopausal state | Female Sterilization | Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0700589
males must not intend to impregnate a partner during the study or for 30 days after the study and must also practice acceptable birth control with their partners
Descripción

Gender | Fertilization intended Partner | Contraceptive methods Partner

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0015914
UMLS CUI [2,2]
C1283828
UMLS CUI [2,3]
C0682323
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0682323
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant long-lasting disease of the immune system other than multiple sclerosis
Descripción

Chronic disease of immune system Significant | Multiple Sclerosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1290894
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0026769
past or current medical disease (heart, liver, kidney, etc.) including severe asthma, cancer or advancing brain or spinal cord disorder
Descripción

Disease | Heart Disease | Liver disease | Kidney Disease | Severe asthma | Malignant Neoplasms | Brain Disease Advanced | Spinal Cord Disease Advanced

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0581126
UMLS CUI [6]
C0006826
UMLS CUI [7,1]
C0006111
UMLS CUI [7,2]
C0205179
UMLS CUI [8,1]
C0037928
UMLS CUI [8,2]
C0205179
known or suspected long-lasting infectious disease including hiv, hepatitis b, or hepatitis c
Descripción

Communicable Disease Long-term | HIV Infection | Hepatitis B | Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0443252
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
treatment with certain steroid or hormone medications within 30 days before the pre-study mri scan
Descripción

Steroids | Hormone Therapy | MRI Scan Pre-study

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2]
C0279025
UMLS CUI [3,1]
C0917711
UMLS CUI [3,2]
C1527048
treatment with other medications that suppress the immune system within 6 months before the pre-study mri scan
Descripción

Immunosuppressive Agents | MRI Scan Pre-study

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2,1]
C0917711
UMLS CUI [2,2]
C1527048
certain treatments and medications are not allowed
Descripción

Therapeutic procedure Illicit | Pharmaceutical Preparations Illicit

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332266
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332266
laboratory and other tests will be performed to determine further eligibility
Descripción

Laboratory Procedures Eligibility Determination | Tests Eligibility Determination

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0013893
UMLS CUI [2,1]
C0392366
UMLS CUI [2,2]
C0013893
history of drug or alcohol abuse in the last year
Descripción

substance abuse

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
history of medical or psychiatric condition that could pose a risk for participation in the study
Descripción

Medical condition Resulting in Risk Study Subject Participation Status | Mental condition Resulting in Risk Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0035647
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0332294
UMLS CUI [2,3]
C0035647
UMLS CUI [2,4]
C2348568
females who are pregnant or breast feeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
participation in any other trial of an investigational agent within 90 days before the start of the study
Descripción

Study Subject Participation Status | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
history of not following instructions with past therapy.
Descripción

Compliance behavior Limited

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
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Similar models

Eligibility Multiple Sclerosis NCT00079495

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female, 18 to 55 years of age
boolean
C0001779 (UMLS CUI [1])
Multiple sclerosis relapse | Relapse Quantity
Item
diagnosed with relapsing multiple sclerosis, with at least one relapse in the last two years
boolean
C0856120 (UMLS CUI [1])
C0035020 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Pregnancy, Planned
Item
females must not plan on becoming pregnant
boolean
C0032992 (UMLS CUI [1])
Gender | Postmenopausal state | Female Sterilization | Contraceptive methods
Item
females must either be post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control and willing to continue birth control until 30 days after the last dose of study drug
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
Gender | Fertilization intended Partner | Contraceptive methods Partner
Item
males must not intend to impregnate a partner during the study or for 30 days after the study and must also practice acceptable birth control with their partners
boolean
C0079399 (UMLS CUI [1])
C0015914 (UMLS CUI [2,1])
C1283828 (UMLS CUI [2,2])
C0682323 (UMLS CUI [2,3])
C0700589 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Chronic disease of immune system Significant | Multiple Sclerosis
Item
significant long-lasting disease of the immune system other than multiple sclerosis
boolean
C1290894 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0026769 (UMLS CUI [2])
Disease | Heart Disease | Liver disease | Kidney Disease | Severe asthma | Malignant Neoplasms | Brain Disease Advanced | Spinal Cord Disease Advanced
Item
past or current medical disease (heart, liver, kidney, etc.) including severe asthma, cancer or advancing brain or spinal cord disorder
boolean
C0012634 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0581126 (UMLS CUI [5])
C0006826 (UMLS CUI [6])
C0006111 (UMLS CUI [7,1])
C0205179 (UMLS CUI [7,2])
C0037928 (UMLS CUI [8,1])
C0205179 (UMLS CUI [8,2])
Communicable Disease Long-term | HIV Infection | Hepatitis B | Hepatitis C
Item
known or suspected long-lasting infectious disease including hiv, hepatitis b, or hepatitis c
boolean
C0009450 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
C0019693 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
Steroids | Hormone Therapy | MRI Scan Pre-study
Item
treatment with certain steroid or hormone medications within 30 days before the pre-study mri scan
boolean
C0038317 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0917711 (UMLS CUI [3,1])
C1527048 (UMLS CUI [3,2])
Immunosuppressive Agents | MRI Scan Pre-study
Item
treatment with other medications that suppress the immune system within 6 months before the pre-study mri scan
boolean
C0021081 (UMLS CUI [1])
C0917711 (UMLS CUI [2,1])
C1527048 (UMLS CUI [2,2])
Therapeutic procedure Illicit | Pharmaceutical Preparations Illicit
Item
certain treatments and medications are not allowed
boolean
C0087111 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0332266 (UMLS CUI [2,2])
Laboratory Procedures Eligibility Determination | Tests Eligibility Determination
Item
laboratory and other tests will be performed to determine further eligibility
boolean
C0022885 (UMLS CUI [1,1])
C0013893 (UMLS CUI [1,2])
C0392366 (UMLS CUI [2,1])
C0013893 (UMLS CUI [2,2])
substance abuse
Item
history of drug or alcohol abuse in the last year
boolean
C0038586 (UMLS CUI [1])
Medical condition Resulting in Risk Study Subject Participation Status | Mental condition Resulting in Risk Study Subject Participation Status
Item
history of medical or psychiatric condition that could pose a risk for participation in the study
boolean
C3843040 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0035647 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C0332294 (UMLS CUI [2,2])
C0035647 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
Pregnancy | Breast Feeding
Item
females who are pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
participation in any other trial of an investigational agent within 90 days before the start of the study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Compliance behavior Limited
Item
history of not following instructions with past therapy.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
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