Informações:
Falhas:
ID
23462
Descrição
Study of Antithymocyte Globulin for Treatment of New-onset T1DM; ODM derived from: https://clinicaltrials.gov/show/NCT00515099
Link
https://clinicaltrials.gov/show/NCT00515099
Palavras-chave
Versões (1)
- 05/07/2017 05/07/2017 -
Transferido a
5 de julho de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility New-onset Type 1 Diabetes Mellitus NCT00515099
Eligibility New-onset Type 1 Diabetes Mellitus NCT00515099
- StudyEvent: Eligibility
Similar models
Eligibility New-onset Type 1 Diabetes Mellitus NCT00515099
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
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])
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])
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])