ID

36459

Beschrijving

Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT02034188

Link

https://clinicaltrials.gov/show/NCT02034188

Trefwoorden

Versies (1)
  1. 15-05-19 15-05-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

15 mei 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02034188

Engels

Eligibility Multiple Sclerosis NCT02034188

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients willing to sign informed consent and capable of understanding the features of this clinical trial.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
willing to keep a weekly diary and undergo observation for 12 months
Beschrijving

Subject Diary Weekly | Observation Receive

Datatype

boolean

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0332174
UMLS CUI [2,1]
C0302523
UMLS CUI [2,2]
C1514756
non-pregnant patients 18-55 years of age with ms according to the revised mcdonald criteria and meeting the poser criteria for clinically defined ms.
Beschrijving

Pregnancy Absent | Age | Multiple Sclerosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0026769
edss scores of 2·0 to 5·5 points assessed at least 3 months after the last acute attack of ms.
Beschrijving

EDSS | Status post Multiple Sclerosis Attack

Datatype

boolean

Alias
UMLS CUI [1]
C0451246
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0026769
UMLS CUI [2,3]
C1304680
must have proof of health insurance in country of residence.
Beschrijving

Health Insurance Country of residence

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021682
UMLS CUI [1,2]
C1562954
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with evidence of active proliferative retinopathy.
Beschrijving

Proliferative retinopathy

Datatype

boolean

Alias
UMLS CUI [1]
C0339467
patients with poorly controlled diabetes mellitus (glycated hemoglobin: hba1c > 8.5%).
Beschrijving

Poorly controlled diabetes mellitus | Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0554876
UMLS CUI [2]
C0474680
patients with renal insufficiency (creatinine> 2.5) or failure.
Beschrijving

Renal Insufficiency | Creatinine measurement, serum | Kidney Failure

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0035078
infection as evidenced by white blood cell (wbc) count of >15,000 k/cumm and/or temperature > 38 celsius.
Beschrijving

Communicable Disease | White Blood Cell Count procedure | Body temperature measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0886414
history of organ transplant.
Beschrijving

Organ Transplantation

Datatype

boolean

Alias
UMLS CUI [1]
C0029216
history of previous or active malignancy, except for localised cutaneous basal or squamous cell carcinoma or carcinoma in situ of the cervix
Beschrijving

Malignant Neoplasms | Exception Basal cell carcinoma Localized | Exception Squamous cell carcinoma of skin Localized | Exception Carcinoma in situ of uterine cervix

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C0392752
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C0392752
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
exercise limiting angina ( canadian cardiovascular society class 3
Beschrijving

Angina Pectoris Limiting Exercise | Canadian Cardiovascular Society Grading Scale Class

Datatype

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0015259
UMLS CUI [2]
C1879987
congestive heart failure (new york heart association class 3
Beschrijving

Congestive heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
unstable angina
Beschrijving

Angina, Unstable

Datatype

boolean

Alias
UMLS CUI [1]
C0002965
acute st elevation myocardial infarction (mi) within 1month
Beschrijving

ST segment elevation myocardial infarction

Datatype

boolean

Alias
UMLS CUI [1]
C1536220
transient ischemic heart attack or stroke within 1 month
Beschrijving

Transient Ischemic Attack | Cerebrovascular accident

Datatype

boolean

Alias
UMLS CUI [1]
C0007787
UMLS CUI [2]
C0038454
severe valvular heart disease
Beschrijving

Heart valve disease Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0205082
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Similar models

Eligibility Multiple Sclerosis NCT02034188

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
patients willing to sign informed consent and capable of understanding the features of this clinical trial.
boolean
C0021430 (UMLS CUI [1])
Subject Diary Weekly | Observation Receive
Item
willing to keep a weekly diary and undergo observation for 12 months
boolean
C3890583 (UMLS CUI [1,1])
C0332174 (UMLS CUI [1,2])
C0302523 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
Pregnancy Absent | Age | Multiple Sclerosis
Item
non-pregnant patients 18-55 years of age with ms according to the revised mcdonald criteria and meeting the poser criteria for clinically defined ms.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0026769 (UMLS CUI [3])
EDSS | Status post Multiple Sclerosis Attack
Item
edss scores of 2·0 to 5·5 points assessed at least 3 months after the last acute attack of ms.
boolean
C0451246 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0026769 (UMLS CUI [2,2])
C1304680 (UMLS CUI [2,3])
Health Insurance Country of residence
Item
must have proof of health insurance in country of residence.
boolean
C0021682 (UMLS CUI [1,1])
C1562954 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Proliferative retinopathy
Item
patients with evidence of active proliferative retinopathy.
boolean
C0339467 (UMLS CUI [1])
Poorly controlled diabetes mellitus | Hemoglobin A1c measurement
Item
patients with poorly controlled diabetes mellitus (glycated hemoglobin: hba1c > 8.5%).
boolean
C0554876 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Renal Insufficiency | Creatinine measurement, serum | Kidney Failure
Item
patients with renal insufficiency (creatinine> 2.5) or failure.
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0035078 (UMLS CUI [3])
Communicable Disease | White Blood Cell Count procedure | Body temperature measurement
Item
infection as evidenced by white blood cell (wbc) count of >15,000 k/cumm and/or temperature > 38 celsius.
boolean
C0009450 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0886414 (UMLS CUI [3])
Organ Transplantation
Item
history of organ transplant.
boolean
C0029216 (UMLS CUI [1])
Malignant Neoplasms | Exception Basal cell carcinoma Localized | Exception Squamous cell carcinoma of skin Localized | Exception Carcinoma in situ of uterine cervix
Item
history of previous or active malignancy, except for localised cutaneous basal or squamous cell carcinoma or carcinoma in situ of the cervix
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0392752 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C0392752 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
Angina Pectoris Limiting Exercise | Canadian Cardiovascular Society Grading Scale Class
Item
exercise limiting angina ( canadian cardiovascular society class 3
boolean
C0002962 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,3])
C1879987 (UMLS CUI [2])
Congestive heart failure New York Heart Association Classification
Item
congestive heart failure (new york heart association class 3
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Angina, Unstable
Item
unstable angina
boolean
C0002965 (UMLS CUI [1])
ST segment elevation myocardial infarction
Item
acute st elevation myocardial infarction (mi) within 1month
boolean
C1536220 (UMLS CUI [1])
Transient Ischemic Attack | Cerebrovascular accident
Item
transient ischemic heart attack or stroke within 1 month
boolean
C0007787 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Heart valve disease Severe
Item
severe valvular heart disease
boolean
C0018824 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
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