ID

23462

Description

Study of Antithymocyte Globulin for Treatment of New-onset T1DM; ODM derived from: https://clinicaltrials.gov/show/NCT00515099

Link

https://clinicaltrials.gov/show/NCT00515099

Keywords

Versions (1)
  1. 7/5/17 7/5/17 -
Uploaded on

July 5, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility New-onset Type 1 Diabetes Mellitus NCT00515099

English

Eligibility New-onset Type 1 Diabetes Mellitus NCT00515099

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of type 1 diabetes (according to american diabetes association [ada] criteria) within100 days of enrollment
Description

ID.1

Data type

boolean

Alias
UMLS CUI [1]
C0011854
positive for one or more autoantibodies (anti-glutamic acid decarboxylase [gad], anti-insulin, or ia-2 autoantibodies)
Description

ID.2

Data type

boolean

Alias
UMLS CUI [1]
C1275890
peak stimulated c-peptide level >0.4 pmol/ml or >1.2ng/ml following an mmtt
Description

ID.3

Data type

boolean

Alias
UMLS CUI [1]
C0202100
serologic evidence of prior epstein-barr virus (ebv) infection (ebv seropositive)
Description

ID.4

Data type

boolean

Alias
UMLS CUI [1]
C0241883
willing to use acceptable forms of contraception
Description

ID.5

Data type

boolean

Alias
UMLS CUI [1]
C0009862
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any sign of active infection (e.g., hepatitis, tuberculosis, ebv, cytomegalovirus (cmv), or toxoplasmosis) at screening
Description

ID.6

Data type

boolean

Alias
UMLS CUI [1]
C3714514
positive for human immunodeficiency virus (hiv), tuberculosis, or hepatitis b surface antigen (hbsag) at screening
Description

ID.7

Data type

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0041296
UMLS CUI [1,3]
C0019168
prior history of any significant cardiac disease, such as congestive heart failure, arrhythmia, or structural defects, or suspicion thereof
Description

ID.8

Data type

boolean

Alias
UMLS CUI [1]
C0018799
use of glucocorticoids in the 28 days prior to study entry; or topical use of glucocorticoids
Description

ID.9

Data type

boolean

Alias
UMLS CUI [1]
C0017710
use of diabetes medications (other than insulin) that may affect glucose homeostasis, such as metformin, sulfonylureas, thiazolidinediones, or amylin
Description

ID.10

Data type

boolean

Alias
UMLS CUI [1]
C3842789
evidence of liver dysfunction
Description

ID.11

Data type

boolean

Alias
UMLS CUI [1]
C0086565
evidence of kidney disease
Description

ID.12

Data type

boolean

Alias
UMLS CUI [1]
C0022658
pregnancy or plan to become pregnant
Description

ID.13

Data type

boolean

Alias
UMLS CUI [1]
C0032961
leukopenia (<3,000 leukocytes/µl), neutropenia (<1,500neutrophils/µl), lymphopenia (<800 lymphocytes/µl), or thrombocytopenia (<125,000 platelets/µl).
Description

ID.14

Data type

boolean

Alias
UMLS CUI [1,1]
C0023530
UMLS CUI [1,2]
C0027947
UMLS CUI [1,3]
C0024312
UMLS CUI [1,4]
C0040034
prior treatment with rabbit atg or known hypersensitivity or exposure to rabbit sera-derived products
Description

ID.15

Data type

boolean

Alias
UMLS CUI [1,1]
C0359156
UMLS CUI [1,2]
C0020517
vaccination with a live virus within the last 6 weeks before enrollment
Description

ID.16

Data type

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C1516086
prior or current therapy that is known to cause a significant, ongoing change in the course of t1dm or immunologic status
Description

ID.17

Data type

boolean

Alias
UMLS CUI [1]
C0021081
any condition that may compromise study participation or may confound the interpretation of the study results
Description

ID.18

Data type

boolean

Alias
UMLS CUI [1]
C0012634
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Similar models

Eligibility New-onset Type 1 Diabetes Mellitus NCT00515099

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
diagnosis of type 1 diabetes (according to american diabetes association [ada] criteria) within100 days of enrollment
boolean
C0011854 (UMLS CUI [1])
ID.2
Item
positive for one or more autoantibodies (anti-glutamic acid decarboxylase [gad], anti-insulin, or ia-2 autoantibodies)
boolean
C1275890 (UMLS CUI [1])
ID.3
Item
peak stimulated c-peptide level >0.4 pmol/ml or >1.2ng/ml following an mmtt
boolean
C0202100 (UMLS CUI [1])
ID.4
Item
serologic evidence of prior epstein-barr virus (ebv) infection (ebv seropositive)
boolean
C0241883 (UMLS CUI [1])
ID.5
Item
willing to use acceptable forms of contraception
boolean
C0009862 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.6
Item
any sign of active infection (e.g., hepatitis, tuberculosis, ebv, cytomegalovirus (cmv), or toxoplasmosis) at screening
boolean
C3714514 (UMLS CUI [1])
ID.7
Item
positive for human immunodeficiency virus (hiv), tuberculosis, or hepatitis b surface antigen (hbsag) at screening
boolean
C0019682 (UMLS CUI [1,1])
C0041296 (UMLS CUI [1,2])
C0019168 (UMLS CUI [1,3])
ID.8
Item
prior history of any significant cardiac disease, such as congestive heart failure, arrhythmia, or structural defects, or suspicion thereof
boolean
C0018799 (UMLS CUI [1])
ID.9
Item
use of glucocorticoids in the 28 days prior to study entry; or topical use of glucocorticoids
boolean
C0017710 (UMLS CUI [1])
ID.10
Item
use of diabetes medications (other than insulin) that may affect glucose homeostasis, such as metformin, sulfonylureas, thiazolidinediones, or amylin
boolean
C3842789 (UMLS CUI [1])
ID.11
Item
evidence of liver dysfunction
boolean
C0086565 (UMLS CUI [1])
ID.12
Item
evidence of kidney disease
boolean
C0022658 (UMLS CUI [1])
ID.13
Item
pregnancy or plan to become pregnant
boolean
C0032961 (UMLS CUI [1])
ID.14
Item
leukopenia (<3,000 leukocytes/µl), neutropenia (<1,500neutrophils/µl), lymphopenia (<800 lymphocytes/µl), or thrombocytopenia (<125,000 platelets/µl).
boolean
C0023530 (UMLS CUI [1,1])
C0027947 (UMLS CUI [1,2])
C0024312 (UMLS CUI [1,3])
C0040034 (UMLS CUI [1,4])
ID.15
Item
prior treatment with rabbit atg or known hypersensitivity or exposure to rabbit sera-derived products
boolean
C0359156 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
ID.16
Item
vaccination with a live virus within the last 6 weeks before enrollment
boolean
C0042196 (UMLS CUI [1,1])
C1516086 (UMLS CUI [1,2])
ID.17
Item
prior or current therapy that is known to cause a significant, ongoing change in the course of t1dm or immunologic status
boolean
C0021081 (UMLS CUI [1])
ID.18
Item
any condition that may compromise study participation or may confound the interpretation of the study results
boolean
C0012634 (UMLS CUI [1])
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