Informações:
Falhas:
ID
13196
Descrição
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
Palavras-chave
Versões (1)
- 23/01/2016 23/01/2016 -
Transferido a
23 de janeiro de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00203021
Eligibility Multiple Sclerosis NCT00203021
- StudyEvent: Eligibility
Similar models
Eligibility Multiple Sclerosis NCT00203021
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
pregnancy or lactation
Item
pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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])
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])
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])
C0021079 (UMLS CUI [2,1])
C0392920 | C0024230 (UMLS CUI [2,2])