ID

32634

Beschrijving

PROCHYMAL® (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM); ODM derived from: https://clinicaltrials.gov/show/NCT00690066

Link

https://clinicaltrials.gov/show/NCT00690066

Trefwoorden

Versies (1)
  1. 09-11-18 09-11-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

9 november 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Type 1 Diabetes Mellitus NCT00690066

Engels

Eligibility Type 1 Diabetes Mellitus NCT00690066

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject must have a diagnosis of type 1 diabetes mellitus based on the ada criteria
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
subject must be screened between 2 and 20 weeks from initial t1dm diagnosis
Beschrijving

Screening Required | At initial diagnosis Insulin-Dependent Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C1514873
UMLS CUI [2,1]
C4071762
UMLS CUI [2,2]
C0011854
subject must be between the ages of 12 and 35 (inclusive)
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
subject must have at least one diabetes-related autoantibody present (either gad or ia-2)
Beschrijving

Autoantibodies Quantity Diabetes Related | Anti-GAD antibody | IA-2 antibody

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004358
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0011847
UMLS CUI [1,4]
C0439849
UMLS CUI [2]
C1167897
UMLS CUI [3]
C0528414
subject must have some beta cell function as determined by c-peptide testing
Beschrijving

Beta-Cell Function | C-peptide measurement

Datatype

boolean

Alias
UMLS CUI [1]
C4055385
UMLS CUI [2]
C0202100
subject must be willing to comply with "intensive diabetes management" as directed by the investigator with the goal of maintaining blood glucose as close to normal as possible
Beschrijving

Compliance behavior Diabetes mellitus management | Maintenance Blood glucose normal

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0948092
UMLS CUI [2,1]
C0024501
UMLS CUI [2,2]
C0580545
subject must be willing to comply with the schedule of study visits and protocol requirements
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has body mass index (bmi) ≥ 30
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
subject has evidence of retinopathy at baseline
Beschrijving

Retinal Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0035309
subject has abnormally high lipid levels
Beschrijving

Serum lipids high Abnormal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0428465
UMLS CUI [1,2]
C0205161
subject has abnormal blood pressure
Beschrijving

Abnormal blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0005826
subject has abnormal serum creatinine
Beschrijving

Serum creatinine abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C0438243
subject has evidence of clinically significant proteinuria
Beschrijving

Proteinuria

Datatype

boolean

Alias
UMLS CUI [1]
C0033687
subject has diabetic ketoacidosis
Beschrijving

Diabetic Ketoacidosis

Datatype

boolean

Alias
UMLS CUI [1]
C0011880
subject is being treated for severe active infection of any type
Beschrijving

Communicable Disease Severe Treated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1522326
a female subject who is breast-feeding, pregnant, or intends to become pregnant during the study
Beschrijving

Breast Feeding | Pregnancy | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0032992
subject with clinically relevant uncontrolled medical condition not associated with diabetes (e.g. hematologic, renal, hepatic, neurologic, cardiac, or respiratory)
Beschrijving

Medical condition Uncontrolled | Relationship Absent Diabetes Mellitus | Hematological Disease | Kidney Diseases | Liver diseases | Nervous system disorder | Heart Diseases | Respiration Disorders

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0011849
UMLS CUI [3]
C0018939
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0023895
UMLS CUI [6]
C0027765
UMLS CUI [7]
C0018799
UMLS CUI [8]
C0035204
subject is allergic to bovine or porcine products
Beschrijving

Hypersensitivity Products Bovine | Hypersensitivity Products Porcine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1514468
UMLS CUI [1,3]
C3667982
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1514468
UMLS CUI [2,3]
C3665571
subject has evidence of active malignancy, or prior history of active malignancy that has not been in remission for at least 5 years
Beschrijving

Malignant Neoplasms | Remission Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0544452
UMLS CUI [2,2]
C0332197
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Similar models

Eligibility Type 1 Diabetes Mellitus NCT00690066

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
subject must have a diagnosis of type 1 diabetes mellitus based on the ada criteria
boolean
C0011854 (UMLS CUI [1])
Screening Required | At initial diagnosis Insulin-Dependent Diabetes Mellitus
Item
subject must be screened between 2 and 20 weeks from initial t1dm diagnosis
boolean
C0220908 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C4071762 (UMLS CUI [2,1])
C0011854 (UMLS CUI [2,2])
Age
Item
subject must be between the ages of 12 and 35 (inclusive)
boolean
C0001779 (UMLS CUI [1])
Autoantibodies Quantity Diabetes Related | Anti-GAD antibody | IA-2 antibody
Item
subject must have at least one diabetes-related autoantibody present (either gad or ia-2)
boolean
C0004358 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0011847 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
C1167897 (UMLS CUI [2])
C0528414 (UMLS CUI [3])
Beta-Cell Function | C-peptide measurement
Item
subject must have some beta cell function as determined by c-peptide testing
boolean
C4055385 (UMLS CUI [1])
C0202100 (UMLS CUI [2])
Compliance behavior Diabetes mellitus management | Maintenance Blood glucose normal
Item
subject must be willing to comply with "intensive diabetes management" as directed by the investigator with the goal of maintaining blood glucose as close to normal as possible
boolean
C1321605 (UMLS CUI [1,1])
C0948092 (UMLS CUI [1,2])
C0024501 (UMLS CUI [2,1])
C0580545 (UMLS CUI [2,2])
Protocol Compliance
Item
subject must be willing to comply with the schedule of study visits and protocol requirements
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Body mass index
Item
subject has body mass index (bmi) ≥ 30
boolean
C1305855 (UMLS CUI [1])
Retinal Disease
Item
subject has evidence of retinopathy at baseline
boolean
C0035309 (UMLS CUI [1])
Serum lipids high Abnormal
Item
subject has abnormally high lipid levels
boolean
C0428465 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Abnormal blood pressure
Item
subject has abnormal blood pressure
boolean
C0005826 (UMLS CUI [1])
Serum creatinine abnormal
Item
subject has abnormal serum creatinine
boolean
C0438243 (UMLS CUI [1])
Proteinuria
Item
subject has evidence of clinically significant proteinuria
boolean
C0033687 (UMLS CUI [1])
Diabetic Ketoacidosis
Item
subject has diabetic ketoacidosis
boolean
C0011880 (UMLS CUI [1])
Communicable Disease Severe Treated
Item
subject is being treated for severe active infection of any type
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
Breast Feeding | Pregnancy | Pregnancy, Planned
Item
a female subject who is breast-feeding, pregnant, or intends to become pregnant during the study
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Medical condition Uncontrolled | Relationship Absent Diabetes Mellitus | Hematological Disease | Kidney Diseases | Liver diseases | Nervous system disorder | Heart Diseases | Respiration Disorders
Item
subject with clinically relevant uncontrolled medical condition not associated with diabetes (e.g. hematologic, renal, hepatic, neurologic, cardiac, or respiratory)
boolean
C3843040 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0439849 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0011849 (UMLS CUI [2,3])
C0018939 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0027765 (UMLS CUI [6])
C0018799 (UMLS CUI [7])
C0035204 (UMLS CUI [8])
Hypersensitivity Products Bovine | Hypersensitivity Products Porcine
Item
subject is allergic to bovine or porcine products
boolean
C0020517 (UMLS CUI [1,1])
C1514468 (UMLS CUI [1,2])
C3667982 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1514468 (UMLS CUI [2,2])
C3665571 (UMLS CUI [2,3])
Malignant Neoplasms | Remission Absent
Item
subject has evidence of active malignancy, or prior history of active malignancy that has not been in remission for at least 5 years
boolean
C0006826 (UMLS CUI [1])
C0544452 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
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