ID

36462

Beschrijving

Safety and Efficacy of BMMNC in Multiple Sclerosis (MS); ODM derived from: https://clinicaltrials.gov/show/NCT01883661

Link

https://clinicaltrials.gov/show/NCT01883661

Trefwoorden

Versies (1)
  1. 16-05-19 16-05-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

16 mei 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT01883661

Engels

Eligibility Multiple Sclerosis NCT01883661

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of ms, aged 18 - 65 years. duration of disease: >5 years signed, written informed consent willing and able to comply with study visits according to protocol for the full study period
Beschrijving

Multiple Sclerosis Disease length | Age | Informed Consent | Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0021430
UMLS CUI [4]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients suffering from significant cardiac, renal or hepatic failure or any other disease that may risk the patient or interfere with the ability to interpret the results
Beschrijving

Heart failure | Kidney Failure | Liver Failure | Disease At risk Patient | Disease Interferes with Interpretation Research results

Datatype

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0035078
UMLS CUI [3]
C0085605
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C0030705
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0459471
UMLS CUI [5,4]
C0683954
patient with any active or chronic infection
Beschrijving

Communicable Disease | Chronic infectious disease

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0151317
no life-threatening organ dysfunction.
Beschrijving

Organ dysfunction Life Threatening

Datatype

boolean

Alias
UMLS CUI [1,1]
C0349410
UMLS CUI [1,2]
C2826244
pregnancy or risk of pregnancy.
Beschrijving

Pregnancy | At risk Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0032961
patients who are seropositive for hiv1, hiv2, hepatitis b surface antigen, and hepatitis c
Beschrijving

HIV-1 Seropositive | HIV-2 Seropositive | Hepatitis B Surface Antigens Seropositive | Hepatitis C Seropositive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019704
UMLS CUI [1,2]
C0521143
UMLS CUI [2,1]
C0019707
UMLS CUI [2,2]
C0521143
UMLS CUI [3,1]
C0019168
UMLS CUI [3,2]
C0521143
UMLS CUI [4,1]
C0019196
UMLS CUI [4,2]
C0521143
patients unable to give written informed consent in accordance with research ethics board guidelines
Beschrijving

Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization
Beschrijving

Therapeutic immunosuppression | natalizumab | fingolimod

Datatype

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C1172734
UMLS CUI [3]
C1699926
treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization
Beschrijving

Interferon-beta | glatiramer acetate

Datatype

boolean

Alias
UMLS CUI [1]
C0015980
UMLS CUI [2]
C0289884
treatment with corticosteroids within the 30 days prior to randomization
Beschrijving

Adrenal Cortex Hormones

Datatype

boolean

Alias
UMLS CUI [1]
C0001617
current treatment with an investigational therapy
Beschrijving

Therapy, Investigational

Datatype

boolean

Alias
UMLS CUI [1]
C0949266
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Similar models

Eligibility Multiple Sclerosis NCT01883661

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis Disease length | Age | Informed Consent | Protocol Compliance
Item
confirmed diagnosis of ms, aged 18 - 65 years. duration of disease: >5 years signed, written informed consent willing and able to comply with study visits according to protocol for the full study period
boolean
C0026769 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
C0525058 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Heart failure | Kidney Failure | Liver Failure | Disease At risk Patient | Disease Interferes with Interpretation Research results
Item
patients suffering from significant cardiac, renal or hepatic failure or any other disease that may risk the patient or interfere with the ability to interpret the results
boolean
C0018801 (UMLS CUI [1])
C0035078 (UMLS CUI [2])
C0085605 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0030705 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0459471 (UMLS CUI [5,3])
C0683954 (UMLS CUI [5,4])
Communicable Disease | Chronic infectious disease
Item
patient with any active or chronic infection
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
Organ dysfunction Life Threatening
Item
no life-threatening organ dysfunction.
boolean
C0349410 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
Pregnancy | At risk Pregnancy
Item
pregnancy or risk of pregnancy.
boolean
C0032961 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
HIV-1 Seropositive | HIV-2 Seropositive | Hepatitis B Surface Antigens Seropositive | Hepatitis C Seropositive
Item
patients who are seropositive for hiv1, hiv2, hepatitis b surface antigen, and hepatitis c
boolean
C0019704 (UMLS CUI [1,1])
C0521143 (UMLS CUI [1,2])
C0019707 (UMLS CUI [2,1])
C0521143 (UMLS CUI [2,2])
C0019168 (UMLS CUI [3,1])
C0521143 (UMLS CUI [3,2])
C0019196 (UMLS CUI [4,1])
C0521143 (UMLS CUI [4,2])
Informed Consent Unable
Item
patients unable to give written informed consent in accordance with research ethics board guidelines
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Therapeutic immunosuppression | natalizumab | fingolimod
Item
treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization
boolean
C0021079 (UMLS CUI [1])
C1172734 (UMLS CUI [2])
C1699926 (UMLS CUI [3])
Interferon-beta | glatiramer acetate
Item
treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization
boolean
C0015980 (UMLS CUI [1])
C0289884 (UMLS CUI [2])
Adrenal Cortex Hormones
Item
treatment with corticosteroids within the 30 days prior to randomization
boolean
C0001617 (UMLS CUI [1])
Therapy, Investigational
Item
current treatment with an investigational therapy
boolean
C0949266 (UMLS CUI [1])
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