Informações:
Falhas:
ID
34681
Descrição
Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01189422
Link
https://clinicaltrials.gov/show/NCT01189422
Palavras-chave
Versões (1)
- 23/01/2019 23/01/2019 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
23 de janeiro de 2019
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Type 1 Diabetes Mellitus NCT01189422
Eligibility Type 1 Diabetes Mellitus NCT01189422
- StudyEvent: Eligibility
Similar models
Eligibility Type 1 Diabetes Mellitus NCT01189422
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Randomization | Sign or Symptom Diabetes Mellitus
Item
randomization after 12 weeks but within 12 months from first doctor visit for symptoms or signs of diabetes
boolean
C0034656 (UMLS CUI [1])
C3540840 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
C3540840 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
Diabetes Mellitus, Insulin-Dependent
Item
diagnosis of type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Insulin regime
Item
currently receiving insulin therapy
boolean
C0557978 (UMLS CUI [1])
Fasting C-peptide level Detectable | C-peptide level Stimulated Detectable
Item
detectable fasting or stimulated c-peptide level at screening
boolean
C2208720 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
C0202100 (UMLS CUI [2,1])
C1948023 (UMLS CUI [2,2])
C3830527 (UMLS CUI [2,3])
C3830527 (UMLS CUI [1,2])
C0202100 (UMLS CUI [2,1])
C1948023 (UMLS CUI [2,2])
C3830527 (UMLS CUI [2,3])
Autoantibody test Result Positive | ICA512 autoantibody | IA-2 autoantibody | Glutamic Acid Decarboxylase Autoantibodies | Insulin autoantibody
Item
one positive autoantibody test result at screening: islet-cell autoantibodies (ica512)/islet antigen-2 (ia-2),glutamic acid decarboxylase (gad) autoantibodies, or insulin autoantibodies
boolean
C1272321 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0382981 (UMLS CUI [2])
C0663193 (UMLS CUI [3])
C0017785 (UMLS CUI [4,1])
C0004358 (UMLS CUI [4,2])
C1275890 (UMLS CUI [5])
C1274040 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0382981 (UMLS CUI [2])
C0663193 (UMLS CUI [3])
C0017785 (UMLS CUI [4,1])
C0004358 (UMLS CUI [4,2])
C1275890 (UMLS CUI [5])
Medical condition Interferes with Completion of clinical trial
Item
any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
Monoclonal Antibody Therapy Previous
Item
previous treatment with monoclonal antibody
boolean
C0279694 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,2])
Antidiabetics Oral
Item
current treatment with oral antidiabetic agents
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1527415 (UMLS CUI [1,2])
Communicable Disease
Item
evidence of active infection
boolean
C0009450 (UMLS CUI [1])
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