ID

16525

Description

Interferon-Alpha for Diabetes Mellitus Type 1; ODM derived from: https://clinicaltrials.gov/show/NCT00024518

Link

https://clinicaltrials.gov/show/NCT00024518

Keywords

Versions (1)
  1. 7/22/16 7/22/16 -
Uploaded on

July 22, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Insulin-Dependent Diabetes Mellitus NCT00024518

English

Eligibility Insulin-Dependent Diabetes Mellitus NCT00024518

1 forms  
Criteria
Description

Criteria

t1dm of less than 6 weeks duration in patients between 3 and 25 years of age.
Description

t1dm of less than 6 weeks duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0001779
besides t1dm, no concurrent illness.
Description

besides t1dm, no concurrent illness.

Data type

boolean

Alias
UMLS CUI [1]
C0009488
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with immunosuppressive or immunostimulatory medications such as azathioprine, nicotinamide, superoxide dismutase-desferroxamine, aminoguanidine, oral insulin or other experimental therapies at the present time or in the past.
Description

treatment with immunosuppressive or immunostimulatory medications

Data type

boolean

Alias
UMLS CUI [1]
C0021079
abnormal pre-treatment white blood cell count (wbc) or thrombocytopenia.
Description

abnormal pre-treatment white blood cell count (wbc) or thrombocytopenia.

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0040034
known active diseases, e.g. cardiac, renal, hepatic diseases or immunodeficiency.
Description

known active diseases

Data type

boolean

Alias
UMLS CUI [1]
C2707252
history of cancer, neuropathy seizure disorders (except typical history of febrile seizures in childhood), peripheral vascular disease, coagulation abnormalities, autoimmune disease (except type 1 diabetes) or cerebrovascular disease.
Description

comorbidities

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0027765
UMLS CUI [3]
C0085096
UMLS CUI [4]
C0004364
UMLS CUI [5]
C0007820
ongoing use of medications known to influence glucose tolerance (e.g. sulfonylureas, metformin, diphenylhydantoin, thiazide or other potassium depleting diuretics, beta-adrenergic blockers, niacin) except insulin.
Description

ongoing use of medications except insulin

Data type

boolean

Alias
UMLS CUI [1,1]
C0205420
UMLS CUI [1,2]
C0013227
any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
Description

medical condition compromising trial protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
inability to give informed consent or assent.
Description

inability to give informed consent or assent.

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
participation in a clinical trial within the previous 6 weeks.
Description

clinical trial participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
lactating or pregnant female individual (individuals will be advised not to volunteer for the protocol if they plan to become pregnant during the time of the study and they are instructed to use an effective method of contraception).
Description

pregnant or lactating

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
age above 25 years, since there may be several subtypes of t1dm.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
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Similar models

Eligibility Insulin-Dependent Diabetes Mellitus NCT00024518

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
t1dm of less than 6 weeks duration
Item
t1dm of less than 6 weeks duration in patients between 3 and 25 years of age.
boolean
C0011854 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
besides t1dm, no concurrent illness.
Item
besides t1dm, no concurrent illness.
boolean
C0009488 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
treatment with immunosuppressive or immunostimulatory medications
Item
treatment with immunosuppressive or immunostimulatory medications such as azathioprine, nicotinamide, superoxide dismutase-desferroxamine, aminoguanidine, oral insulin or other experimental therapies at the present time or in the past.
boolean
C0021079 (UMLS CUI [1])
abnormal pre-treatment white blood cell count (wbc) or thrombocytopenia.
Item
abnormal pre-treatment white blood cell count (wbc) or thrombocytopenia.
boolean
C0023508 (UMLS CUI [1])
C0040034 (UMLS CUI [2])
known active diseases
Item
known active diseases, e.g. cardiac, renal, hepatic diseases or immunodeficiency.
boolean
C2707252 (UMLS CUI [1])
comorbidities
Item
history of cancer, neuropathy seizure disorders (except typical history of febrile seizures in childhood), peripheral vascular disease, coagulation abnormalities, autoimmune disease (except type 1 diabetes) or cerebrovascular disease.
boolean
C0006826 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
C0085096 (UMLS CUI [3])
C0004364 (UMLS CUI [4])
C0007820 (UMLS CUI [5])
ongoing use of medications except insulin
Item
ongoing use of medications known to influence glucose tolerance (e.g. sulfonylureas, metformin, diphenylhydantoin, thiazide or other potassium depleting diuretics, beta-adrenergic blockers, niacin) except insulin.
boolean
C0205420 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
medical condition compromising trial protocol
Item
any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
inability to give informed consent or assent.
Item
inability to give informed consent or assent.
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
clinical trial participation status
Item
participation in a clinical trial within the previous 6 weeks.
boolean
C2348568 (UMLS CUI [1])
pregnant or lactating
Item
lactating or pregnant female individual (individuals will be advised not to volunteer for the protocol if they plan to become pregnant during the time of the study and they are instructed to use an effective method of contraception).
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
age
Item
age above 25 years, since there may be several subtypes of t1dm.
boolean
C0001779 (UMLS CUI [1])
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