ID

13196

Beskrivning

Copaxone® Study to Follow Patients From the First Original Study for Safety and Effectiveness.; ODM derived from: https://clinicaltrials.gov/show/NCT00203021

Länk

https://clinicaltrials.gov/show/NCT00203021

Nyckelord

Versioner (1)
  1. 2016-01-23 2016-01-23 -
Uppladdad den

23 januari 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00203021

Engelsk

Eligibility Multiple Sclerosis NCT00203021

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have participated (been randomized) in the copaxone double-blind placebo controlled study (protocol 01-9001).
Beskrivning

copaxone study participation

Datatyp

boolean

Alias
UMLS CUI [1]
C0528175
UMLS CUI [2]
C2348568
gender: patients may be male or female. women of childbearing potential must practice an acceptable method of birth control.
Beskrivning

Gender, birth control

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0700589
patients must meet the criteria of clinically definite ms as defined by poser.5
Beskrivning

multiple sclerosis diagnosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0026769
the patient's signs and symptoms cannot be better explained by another disease process.
Beskrivning

multiple sclerosis diagnosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0026769
patients must sign an approved informed consent prior to initiating the study.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
patients must be psychologically and physically stable to participate in the trial as judged by the investigator.
Beskrivning

psychologically and physically stable

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or lactation.
Beskrivning

pregnancy or lactation

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
medical or psychiatric conditions that affect the patient's ability to give informed consent or complete the study.
Beskrivning

nformed consent or study completion limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0021430
UMLS CUI [1,4]
C0439801
UMLS CUI [1,5]
C0009488
inability to self-administer subcutaneous medication or lack of another responsible individual to administer the study preparation daily.
Beskrivning

subcutaneous medication

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0021499
use of interferons, experimental ms therapies, or previous immunosuppressive therapy with cytotoxic chemotherapy (azathioprine, cyclophosphamide, or cyclosporine), or total lymphoid irradiation within 30 days of study entry.
Beskrivning

interferons, experimental ms therapies, immunosuppression or lymphoid irradiation

Datatyp

boolean

Alias
UMLS CUI [1]
C0021747
UMLS CUI [2,1]
C0021079
UMLS CUI [2,2]
C0392920 | C0024230
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Similar models

Eligibility Multiple Sclerosis NCT00203021

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
copaxone study participation
Item
patients must have participated (been randomized) in the copaxone double-blind placebo controlled study (protocol 01-9001).
boolean
C0528175 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Gender, birth control
Item
gender: patients may be male or female. women of childbearing potential must practice an acceptable method of birth control.
boolean
C0079399 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
multiple sclerosis diagnosis
Item
patients must meet the criteria of clinically definite ms as defined by poser.5
boolean
C0026769 (UMLS CUI [1])
multiple sclerosis diagnosis
Item
the patient's signs and symptoms cannot be better explained by another disease process.
boolean
C0026769 (UMLS CUI [1])
informed consent
Item
patients must sign an approved informed consent prior to initiating the study.
boolean
C0021430 (UMLS CUI [1])
psychologically and physically stable
Item
patients must be psychologically and physically stable to participate in the trial as judged by the investigator.
boolean
C0009488 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnancy or lactation
Item
pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
nformed consent or study completion limited
Item
medical or psychiatric conditions that affect the patient's ability to give informed consent or complete the study.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
C0009488 (UMLS CUI [1,5])
subcutaneous medication
Item
inability to self-administer subcutaneous medication or lack of another responsible individual to administer the study preparation daily.
boolean
C1321605 (UMLS CUI [1])
C0021499 (UMLS CUI [2])
interferons, experimental ms therapies, immunosuppression or lymphoid irradiation
Item
use of interferons, experimental ms therapies, or previous immunosuppressive therapy with cytotoxic chemotherapy (azathioprine, cyclophosphamide, or cyclosporine), or total lymphoid irradiation within 30 days of study entry.
boolean
C0021747 (UMLS CUI [1])
C0021079 (UMLS CUI [2,1])
C0392920 | C0024230 (UMLS CUI [2,2])
Tillbaka till toppen 

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