ID

36458

Beskrivning

Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Into Patients With Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT01453764

Länk

https://clinicaltrials.gov/show/NCT01453764

Nyckelord

Versioner (1)
  1. 2019-05-15 2019-05-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 maj 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT01453764

Engelsk

Eligibility Multiple Sclerosis NCT01453764

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females between age 18 and 80 years.
Beskrivning

Age

Datatyp

boolean

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

Disease length

Datatyp

boolean

Alias
UMLS CUI [1]
C0872146
failure to respond or intolerance to the currently available multiple sclerosis (ms) immunomodulatory treatments (ie interferons, copaxone, immunosuppression): the lack of response to these treatments will be determined/defined by either an increase (deterioration) of at least one degree in the expanded disability status scale (edss) score during the last year or the appearance of at least two major relapses of ms during the same period of time (under treatment) or intolerance to these agents.
Beskrivning

Immunomodulation Multiple Sclerosis | Response failed | Intolerance Immunomodulation | Interferon | Copaxone | Therapeutic immunosuppression | EDSS | Multiple sclerosis relapse Major Quantity | Intolerance to Interferon | Intolerance to Copaxone

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1963758
UMLS CUI [1,2]
C0026769
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0231175
UMLS CUI [3,1]
C0231199
UMLS CUI [3,2]
C1963758
UMLS CUI [4]
C3652465
UMLS CUI [5]
C0528175
UMLS CUI [6]
C0021079
UMLS CUI [7]
C0451246
UMLS CUI [8,1]
C0856120
UMLS CUI [8,2]
C0205164
UMLS CUI [8,3]
C1265611
UMLS CUI [9,1]
C1744706
UMLS CUI [9,2]
C3652465
UMLS CUI [10,1]
C1744706
UMLS CUI [10,2]
C0528175
up to date on all age and gender appropriate cancer screening per american cancer society .
Beskrivning

Screening for cancer Appropriate Age | Screening for cancer Appropriate Gender

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0199230
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0001779
UMLS CUI [2,1]
C0199230
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C0079399
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
life expectancy < 6 months due to concomitant illnesses.
Beskrivning

Life Expectancy Due to Comorbidity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0009488
exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
Beskrivning

Exposure to Investigational New Drugs | Exposure to Procedure | Study Subject Participation Status Interferes with Research results

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0184661
UMLS CUI [3,1]
C2348568
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
active infectious disease. for patients who have tested positive, an expert will be consulted as to patient eligibility based on the patient's infectious status
Beskrivning

Communicable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
any illness which, in the investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
Beskrivning

Illness Interferes with Protocol Compliance | Illness compromises Patient safety | Illness Interferes with Interpretation Research results

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0459471
UMLS CUI [3,4]
C0683954
patients on chronic immunosuppressive transplant therapy
Beskrivning

Immunosuppressive therapy for transplant chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0521304
UMLS CUI [1,2]
C0205191
systolic blood pressure (supine) ≤90 mmhg;
Beskrivning

Lying systolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C1319895
resting heart rate > 100 bpm;
Beskrivning

RESTING HEART RATE

Datatyp

boolean

Alias
UMLS CUI [1]
C1821417
active clinical infection.
Beskrivning

Communicable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
cerebrovascular accident within 6 months prior to study entry
Beskrivning

Cerebrovascular accident

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
Beskrivning

Substance Dependence | Factor Interferes with Completion of clinical trial | Factor Interferes with Interpretation Research results | Factor Study Subject Participation Status Inappropriate

Datatyp

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2732579
UMLS CUI [3,1]
C1521761
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0459471
UMLS CUI [3,4]
C0683954
UMLS CUI [4,1]
C1521761
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C1548788
history of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
Beskrivning

Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
unwilling and/or not able to give written informed consent.
Beskrivning

Informed Consent Unwilling | Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
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Similar models

Eligibility Multiple Sclerosis NCT01453764

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males and females between age 18 and 80 years.
boolean
C0001779 (UMLS CUI [1])
Disease length
Item
duration of disease: >5 years
boolean
C0872146 (UMLS CUI [1])
Immunomodulation Multiple Sclerosis | Response failed | Intolerance Immunomodulation | Interferon | Copaxone | Therapeutic immunosuppression | EDSS | Multiple sclerosis relapse Major Quantity | Intolerance to Interferon | Intolerance to Copaxone
Item
failure to respond or intolerance to the currently available multiple sclerosis (ms) immunomodulatory treatments (ie interferons, copaxone, immunosuppression): the lack of response to these treatments will be determined/defined by either an increase (deterioration) of at least one degree in the expanded disability status scale (edss) score during the last year or the appearance of at least two major relapses of ms during the same period of time (under treatment) or intolerance to these agents.
boolean
C1963758 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0231199 (UMLS CUI [3,1])
C1963758 (UMLS CUI [3,2])
C3652465 (UMLS CUI [4])
C0528175 (UMLS CUI [5])
C0021079 (UMLS CUI [6])
C0451246 (UMLS CUI [7])
C0856120 (UMLS CUI [8,1])
C0205164 (UMLS CUI [8,2])
C1265611 (UMLS CUI [8,3])
C1744706 (UMLS CUI [9,1])
C3652465 (UMLS CUI [9,2])
C1744706 (UMLS CUI [10,1])
C0528175 (UMLS CUI [10,2])
Screening for cancer Appropriate Age | Screening for cancer Appropriate Gender
Item
up to date on all age and gender appropriate cancer screening per american cancer society .
boolean
C0199230 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,3])
C0199230 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0079399 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling
Item
females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
Life Expectancy Due to Comorbidity
Item
life expectancy < 6 months due to concomitant illnesses.
boolean
C0023671 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Exposure to Investigational New Drugs | Exposure to Procedure | Study Subject Participation Status Interferes with Research results
Item
exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
boolean
C0332157 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0184661 (UMLS CUI [2,2])
C2348568 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
Communicable Disease
Item
active infectious disease. for patients who have tested positive, an expert will be consulted as to patient eligibility based on the patient's infectious status
boolean
C0009450 (UMLS CUI [1])
Illness Interferes with Protocol Compliance | Illness compromises Patient safety | Illness Interferes with Interpretation Research results
Item
any illness which, in the investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
boolean
C0221423 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0221423 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0459471 (UMLS CUI [3,3])
C0683954 (UMLS CUI [3,4])
Immunosuppressive therapy for transplant chronic
Item
patients on chronic immunosuppressive transplant therapy
boolean
C0521304 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Lying systolic blood pressure
Item
systolic blood pressure (supine) ≤90 mmhg;
boolean
C1319895 (UMLS CUI [1])
RESTING HEART RATE
Item
resting heart rate > 100 bpm;
boolean
C1821417 (UMLS CUI [1])
Communicable Disease
Item
active clinical infection.
boolean
C0009450 (UMLS CUI [1])
Cerebrovascular accident
Item
cerebrovascular accident within 6 months prior to study entry
boolean
C0038454 (UMLS CUI [1])
Substance Dependence | Factor Interferes with Completion of clinical trial | Factor Interferes with Interpretation Research results | Factor Study Subject Participation Status Inappropriate
Item
known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
boolean
C0038580 (UMLS CUI [1])
C1521761 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C1521761 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0459471 (UMLS CUI [3,3])
C0683954 (UMLS CUI [3,4])
C1521761 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1548788 (UMLS CUI [4,3])
Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
history of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Informed Consent Unwilling | Informed Consent Unable
Item
unwilling and/or not able to give written informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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