ID

21969

Beschrijving

A Study Comparing Shared Solutions® Plus MS Center Support Versus Shared Solutions® Alone; ODM derived from: https://clinicaltrials.gov/show/NCT00240006

Link

https://clinicaltrials.gov/show/NCT00240006

Trefwoorden

  1. 11-05-17 11-05-17 -
Geüploaded op

11 mei 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Multiple Sclerosis NCT00240006

Eligibility Multiple Sclerosis NCT00240006

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. males or females, 18 years of age or older.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. diagnosed with relapsing remitting multiple sclerosis (relapses accepted).
Beschrijving

Multiple Sclerosis, Relapsing-Remitting | Recurrent disease

Datatype

boolean

Alias
UMLS CUI [1]
C0751967
UMLS CUI [2]
C0277556
3. beginning or restarting therapy with glatiramer acetate (copaxone®).
Beschrijving

glatiramer acetate | Copaxone

Datatype

boolean

Alias
UMLS CUI [1]
C0289884
UMLS CUI [2]
C0528175
4. willing and able to complete all procedures and evaluations related to the study.
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
5. willing to provide informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. taking any other immunomodulatory or immunosuppressant therapy in conjunction with copaxone®.
Beschrijving

Biological Response Modifiers | Therapeutic immunosuppression | Copaxone

Datatype

boolean

Alias
UMLS CUI [1]
C0005525
UMLS CUI [2]
C0021079
UMLS CUI [3]
C0528175
2. has a significant medical illness other than ms that may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study.
Beschrijving

Illness Interferes with Endpoints Assessment | Multiple Sclerosis | Illness Interferes with Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2349179
UMLS CUI [1,4]
C1516048
UMLS CUI [2]
C0026769
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
3. any situation that the investigator or nurse (if not the investigator) feel may interfere with participation in the study.
Beschrijving

Condition Interferes with Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
4. pregnant or trying to become pregnant, or breast feeding during the study.
Beschrijving

Pregnancy | Pregnancy, Planned | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
5. previously participated in this study or another clinical research study in the past 30 days.
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Multiple Sclerosis NCT00240006

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. males or females, 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis, Relapsing-Remitting | Recurrent disease
Item
2. diagnosed with relapsing remitting multiple sclerosis (relapses accepted).
boolean
C0751967 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
glatiramer acetate | Copaxone
Item
3. beginning or restarting therapy with glatiramer acetate (copaxone®).
boolean
C0289884 (UMLS CUI [1])
C0528175 (UMLS CUI [2])
Protocol Compliance
Item
4. willing and able to complete all procedures and evaluations related to the study.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
5. willing to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Biological Response Modifiers | Therapeutic immunosuppression | Copaxone
Item
1. taking any other immunomodulatory or immunosuppressant therapy in conjunction with copaxone®.
boolean
C0005525 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
C0528175 (UMLS CUI [3])
Illness Interferes with Endpoints Assessment | Multiple Sclerosis | Illness Interferes with Study Subject Participation Status
Item
2. has a significant medical illness other than ms that may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study.
boolean
C0221423 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2349179 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,4])
C0026769 (UMLS CUI [2])
C0221423 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
Condition Interferes with Study Subject Participation Status
Item
3. any situation that the investigator or nurse (if not the investigator) feel may interfere with participation in the study.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
4. pregnant or trying to become pregnant, or breast feeding during the study.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Study Subject Participation Status
Item
5. previously participated in this study or another clinical research study in the past 30 days.
boolean
C2348568 (UMLS CUI [1])

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