ID

36490

Beschreibung

Multi-Center Study Safety of Adipose Derived Mesenchymal Stem Cells for the Treatment of Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT02326935

Link

https://clinicaltrials.gov/show/NCT02326935

Stichworte

Versionen (1)
  1. 17.05.19 17.05.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

17. Mai 2019

DOI

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Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02326935

Englisch

Eligibility Multiple Sclerosis NCT02326935

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of ms
Beschreibung

Multiple Sclerosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0026769
aged 18 - 65 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
duration of disease: >5 years
Beschreibung

Disease length

Datentyp

boolean

Alias
UMLS CUI [1]
C0872146
signed, written informed consent willing and able to comply with study visits according to protocol for the full study period
Beschreibung

Informed Consent | Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
physically, mentally and legally capable of international travel for treatment
Beschreibung

Capability Travel International | Legal capacity Travel International | Travel International Therapeutic aspects

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2698977
UMLS CUI [1,2]
C0040802
UMLS CUI [1,3]
C1512888
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0040802
UMLS CUI [2,3]
C1512888
UMLS CUI [3,1]
C0040802
UMLS CUI [3,2]
C1512888
UMLS CUI [3,3]
C0039798
Exclusion Criteria
Beschreibung

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
Beschreibung

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

Datentyp

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
Beschreibung

Communicable Disease | Chronic infectious disease

Datentyp

boolean

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

Organ dysfunction Life Threatening

Datentyp

boolean

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

Pregnancy | At risk Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0032961
severe physical limitations or disabilities
Beschreibung

Limitation Physical Severe | Physical disability Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449295
UMLS CUI [1,2]
C0205485
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C0520817
UMLS CUI [2,2]
C0205082
patients who are seropositive for hiv1, hiv2, hepatitis b surface antigen, and hepatitis c
Beschreibung

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

Datentyp

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
Beschreibung

Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
treatment with any immunosuppressive therapy within the 3 months prior to randomization
Beschreibung

Therapeutic immunosuppression

Datentyp

boolean

Alias
UMLS CUI [1]
C0021079
current treatment with an investigational therapy
Beschreibung

Therapy, Investigational

Datentyp

boolean

Alias
UMLS CUI [1]
C0949266
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Ähnliche Modelle

Eligibility Multiple Sclerosis NCT02326935

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis
Item
confirmed diagnosis of ms
boolean
C0026769 (UMLS CUI [1])
Age
Item
aged 18 - 65 years.
boolean
C0001779 (UMLS CUI [1])
Disease length
Item
duration of disease: >5 years
boolean
C0872146 (UMLS CUI [1])
Informed Consent | Protocol Compliance
Item
signed, written informed consent willing and able to comply with study visits according to protocol for the full study period
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Capability Travel International | Legal capacity Travel International | Travel International Therapeutic aspects
Item
physically, mentally and legally capable of international travel for treatment
boolean
C2698977 (UMLS CUI [1,1])
C0040802 (UMLS CUI [1,2])
C1512888 (UMLS CUI [1,3])
C0683673 (UMLS CUI [2,1])
C0040802 (UMLS CUI [2,2])
C1512888 (UMLS CUI [2,3])
C0040802 (UMLS CUI [3,1])
C1512888 (UMLS CUI [3,2])
C0039798 (UMLS CUI [3,3])
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])
Limitation Physical Severe | Physical disability Severe
Item
severe physical limitations or disabilities
boolean
C0449295 (UMLS CUI [1,1])
C0205485 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0520817 (UMLS CUI [2,1])
C0205082 (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
Item
treatment with any immunosuppressive therapy within the 3 months prior to randomization
boolean
C0021079 (UMLS CUI [1])
Therapy, Investigational
Item
current treatment with an investigational therapy
boolean
C0949266 (UMLS CUI [1])
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