ID

13196

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00203021

Stichworte

  1. 23.01.16 23.01.16 -
Hochgeladen am

23. Januar 2016

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Multiple Sclerosis NCT00203021

Eligibility Multiple Sclerosis NCT00203021

Inclusion Criteria
Beschreibung

Inclusion Criteria

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

copaxone study participation

Datentyp

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.
Beschreibung

Gender, birth control

Datentyp

boolean

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

multiple sclerosis diagnosis

Datentyp

boolean

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

multiple sclerosis diagnosis

Datentyp

boolean

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

informed consent

Datentyp

boolean

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

psychologically and physically stable

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or lactation.
Beschreibung

pregnancy or lactation

Datentyp

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.
Beschreibung

nformed consent or study completion limited

Datentyp

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.
Beschreibung

subcutaneous medication

Datentyp

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.
Beschreibung

interferons, experimental ms therapies, immunosuppression or lymphoid irradiation

Datentyp

boolean

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

Ähnliche Modelle

Eligibility Multiple Sclerosis NCT00203021

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])

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