Informações:
Falhas:
ID
37019
Descrição
Autologous Mesenchymal Stromal Cells for Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT02495766
Link
https://clinicaltrials.gov/show/NCT02495766
Palavras-chave
Versões (1)
- 30/06/2019 30/06/2019 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
30 de junho de 2019
DOI
Para um pedido faça login.
Licença
Creative Commons BY 4.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
Eligibility Relapsing-Remitting Multiple Sclerosis NCT02495766
Eligibility Relapsing-Remitting Multiple Sclerosis NCT02495766
- StudyEvent: Eligibility
Similar models
Eligibility Relapsing-Remitting Multiple Sclerosis NCT02495766
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age
Item
patients between 18 and 60 years of age
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis
Item
patients with ms
boolean
C0026769 (UMLS CUI [1])
Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Secondary Progressive
Item
relapsing-remitting or secondary progressive ms
boolean
C0751967 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C0751965 (UMLS CUI [2])
Indication Absent Biological Response Modifier Therapy
Item
patients to whom are not indicated or are not in a position to initiate treatment with disease-modifying drugs
boolean
C3146298 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0005527 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,2])
C0005527 (UMLS CUI [1,3])
EDSS
Item
expanded disability status scale (edds) score <6.5
boolean
C0451246 (UMLS CUI [1])
Lesion T2 Quantity
Item
nine t2 lesions at least
boolean
C0221198 (UMLS CUI [1,1])
C3472340 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3472340 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Multiple Sclerosis | Event Quantity Past Year | Gadolinium-Enhancing Lesion Quantity
Item
active multiple sclerosis as defined either by 1 outbreak in the last year or at least one gadolinium-enhancing lesion in the last 6 months
boolean
C0026769 (UMLS CUI [1])
C0441471 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C4086728 (UMLS CUI [2,3])
C1333400 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0441471 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C4086728 (UMLS CUI [2,3])
C1333400 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Informed Consent
Item
signed informed consent form
boolean
C0021430 (UMLS CUI [1])
Interferon-beta | glatiramer acetate
Item
interferon beta or glatiramer acetate 3 months prior the screening
boolean
C0015980 (UMLS CUI [1])
C0289884 (UMLS CUI [2])
C0289884 (UMLS CUI [2])
natalizumab | fingolimod
Item
natalizumab or fingolimod in the 6 months prior the screening
boolean
C1172734 (UMLS CUI [1])
C1699926 (UMLS CUI [2])
C1699926 (UMLS CUI [2])
Mitoxantrone | Cyclophosphamide | Therapeutic immunosuppression
Item
mitoxantrone, cyclophosphamide or other immunosuppressive therapy at any time
boolean
C0026259 (UMLS CUI [1])
C0010583 (UMLS CUI [2])
C0021079 (UMLS CUI [3])
C0010583 (UMLS CUI [2])
C0021079 (UMLS CUI [3])
Therapy, Investigational
Item
has received an experimental treatment within 3 months prior the screening
boolean
C0949266 (UMLS CUI [1])
Multiple Sclerosis Event Recent
Item
ms outbreak within the 4 weeks prior the randomization
boolean
C0026769 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0441471 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Creatinine measurement, serum
Item
serum creatinine> 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Communicable Disease | Communicable Disease Uncontrolled
Item
infectious disease active or uncontrolled
boolean
C0009450 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Patients Fertile | Contraceptive methods Absent
Item
fertile patients who are not using a suitable method of contraception
boolean
C0030705 (UMLS CUI [1,1])
C0015895 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0015895 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Immunodeficiency
Item
immunodeficiency
boolean
C0021051 (UMLS CUI [1])
HIV Seropositivity | Hepatitis B Seropositive | Hepatitis C Seropositive | Syphilis Seropositive
Item
positive serology to hiv, hepatitis b, hepatitis c or syphilis
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2,1])
C0521143 (UMLS CUI [2,2])
C0019196 (UMLS CUI [3,1])
C0521143 (UMLS CUI [3,2])
C0039128 (UMLS CUI [4,1])
C0521143 (UMLS CUI [4,2])
C0019163 (UMLS CUI [2,1])
C0521143 (UMLS CUI [2,2])
C0019196 (UMLS CUI [3,1])
C0521143 (UMLS CUI [3,2])
C0039128 (UMLS CUI [4,1])
C0521143 (UMLS CUI [4,2])