ID

17150

Description

A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52 Antibody) Therapy in Newly Diagnosed Subjects With Type 1 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00214214

Link

https://clinicaltrials.gov/show/NCT00214214

Keywords

Versions (1)
  1. 8/28/16 8/28/16 -
Uploaded on

August 28, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility New Onset Type 1 Diabetes Mellitus NCT00214214

English

Eligibility New Onset Type 1 Diabetes Mellitus NCT00214214

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult subjects ages 18-35, with new onset type 1 diabetes mellitus (within 2-12 weeks of diagnosis), one or more islet autoantibody to gad, ia2, iaa or islet cell cytoplasmic antibody (ica) within 2 weeks of diabetes diagnosis.
Description

Age, Diabetes Mellitus Type I

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011854
UMLS CUI [3]
C1167897
UMLS CUI [4]
C3203592
UMLS CUI [5]
C1275890
UMLS CUI [6]
C0063900
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects under 18 years of age or over 35 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects who have previously received an organ transplant.
Description

Organ transplant

Data type

boolean

Alias
UMLS CUI [1]
C0029216
subjects who are currently receiving systemic corticosteroids for other medical diseases in which the physician feels discontinuation of corticosteroids is contraindicated.
Description

Systemic corticosteroids

Data type

boolean

Alias
UMLS CUI [1]
C2825233
subjects with a history of other medical condition(s) known to affect blood glucose values (i.e., cushing's disease, acromegaly).
Description

Other medical condition(s) known to affect blood glucose values

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005802
subjects with a history of other chronic systemic inflammatory or autoimmune disease or other severe medical condition. (a history of treated hypothyroidism with documentation of normal serum thyroid hormone levels will not be exclusionary.)
Description

Chronic systemic inflammatory or autoimmune disease or other severe medical condition

Data type

boolean

Alias
UMLS CUI [1]
C1290884
UMLS CUI [2]
C0004364
UMLS CUI [3]
C0009488
patients with a history of hepatitis b, hepatitis c, or hiv.
Description

Hepatitis B, Hepatitis C, or HIV

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019693
ppd positive at the time of evaluation.
Description

PPD positive

Data type

boolean

Alias
UMLS CUI [1]
C0032739
thrombocytopenia or neutropenia. individuals will be considered to have thrombocytopenia if they have a platelet count <100,000 platelets/mm2 or <3,000 wbc/ml.
Description

Thrombocytopenia or neutropenia

Data type

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0023508
subjects with a history of renal, pulmonary, or cardiac failure
Description

Renal, pulmonary, or cardiac failure

Data type

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0948755
UMLS CUI [3]
C0018801
subjects with severe systemic infections. only those subjects who have completed treatment and have shown a complete clinical resolution will be considered eligible for the study.
Description

Infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
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Similar models

Eligibility New Onset Type 1 Diabetes Mellitus NCT00214214

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age, Diabetes Mellitus Type I
Item
adult subjects ages 18-35, with new onset type 1 diabetes mellitus (within 2-12 weeks of diagnosis), one or more islet autoantibody to gad, ia2, iaa or islet cell cytoplasmic antibody (ica) within 2 weeks of diabetes diagnosis.
boolean
C0001779 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
C1167897 (UMLS CUI [3])
C3203592 (UMLS CUI [4])
C1275890 (UMLS CUI [5])
C0063900 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Age
Item
subjects under 18 years of age or over 35 years of age.
boolean
C0001779 (UMLS CUI [1])
Organ transplant
Item
subjects who have previously received an organ transplant.
boolean
C0029216 (UMLS CUI [1])
Systemic corticosteroids
Item
subjects who are currently receiving systemic corticosteroids for other medical diseases in which the physician feels discontinuation of corticosteroids is contraindicated.
boolean
C2825233 (UMLS CUI [1])
Other medical condition(s) known to affect blood glucose values
Item
subjects with a history of other medical condition(s) known to affect blood glucose values (i.e., cushing's disease, acromegaly).
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005802 (UMLS CUI [1,3])
Chronic systemic inflammatory or autoimmune disease or other severe medical condition
Item
subjects with a history of other chronic systemic inflammatory or autoimmune disease or other severe medical condition. (a history of treated hypothyroidism with documentation of normal serum thyroid hormone levels will not be exclusionary.)
boolean
C1290884 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
Hepatitis B, Hepatitis C, or HIV
Item
patients with a history of hepatitis b, hepatitis c, or hiv.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
PPD positive
Item
ppd positive at the time of evaluation.
boolean
C0032739 (UMLS CUI [1])
Thrombocytopenia or neutropenia
Item
thrombocytopenia or neutropenia. individuals will be considered to have thrombocytopenia if they have a platelet count <100,000 platelets/mm2 or <3,000 wbc/ml.
boolean
C0032181 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
Renal, pulmonary, or cardiac failure
Item
subjects with a history of renal, pulmonary, or cardiac failure
boolean
C0035078 (UMLS CUI [1])
C0948755 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
Infection
Item
subjects with severe systemic infections. only those subjects who have completed treatment and have shown a complete clinical resolution will be considered eligible for the study.
boolean
C0009450 (UMLS CUI [1])
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