ID

20746

Descrição

Phase 1 Study of BHT-3021 in Subjects With Type 1 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00453375

Link

https://clinicaltrials.gov/show/NCT00453375

Palavras-chave

Versões (1)
  1. 14/03/2017 14/03/2017 -
Transferido a

14 de março de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diabetes NCT00453375

Inglês

Eligibility Diabetes NCT00453375

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00453375
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of type 1a diabetes mellitus based on ada criteria
Descrição

Diabetes Mellitus, Insulin-Dependent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011854
≤5 years since t1d was diagnosed
Descrição

Insulin-Dependent Diabetes Mellitus disease length

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
≥ 18 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
≤ 40 years of age at the time of diagnosis of type 1a diabetes
Descrição

Age | Diabetes Mellitus, Insulin-Dependent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011854
presence of antibodies to at least one of the following antigens:
Descrição

Antibodies Present

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003241
UMLS CUI [1,2]
C0150312
insulin, gad-65, or ia-2
Descrição

Insulin Antibodies | GAD-65 Antibodies | IA-2 Antibodies

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021644
UMLS CUI [2,1]
C0910436
UMLS CUI [2,2]
C0003241
UMLS CUI [3,1]
C0380315
UMLS CUI [3,2]
C0003241
detectable fasting c-peptide level
Descrição

fasting C-peptide level Detectable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2208720
UMLS CUI [1,2]
C3830527
c-peptide increase during screening mixed meal tolerance test with a minimal stimulated value of ≥ 0.2 pmol/ml
Descrição

Insulin C-peptide increased | Meal Mixed Tolerance test

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0861021
UMLS CUI [2,1]
C1998602
UMLS CUI [2,2]
C0205430
UMLS CUI [2,3]
C0201777
presence of antibodies to at least one of the following antigens: insulin, gad-65, or ia-2. if insulin antibody positive only, determination must be within 2 weeks of insulin initiation
Descrição

Antibodies Present | Insulin Antibodies | GAD-65 Antibodies | IA-2 Antibodies

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003241
UMLS CUI [1,2]
C0150312
UMLS CUI [2]
C0021644
UMLS CUI [3,1]
C0910436
UMLS CUI [3,2]
C0003241
UMLS CUI [4,1]
C0380315
UMLS CUI [4,2]
C0003241
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
bmi > 30 kg/m2
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
unstable blood sugar control defined as one or more episodes of severe hypoglycemia (defined as hypoglycemia that required the assistance of another person) within the last 30 days
Descrição

Blood Glucose control Unstable | Hypoglycemia Severe Episode Quantity | Assistance Patient need for

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005802
UMLS CUI [1,2]
C0243148
UMLS CUI [1,3]
C0443343
UMLS CUI [2,1]
C0020615
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0332189
UMLS CUI [2,4]
C1265611
UMLS CUI [3,1]
C1269765
UMLS CUI [3,2]
C0686904
current use of inhalable insulin
Descrição

Insulin Inhalation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0205535
previous immunotherapy for t1d
Descrição

Immunotherapy Insulin-Dependent Diabetes Mellitus

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0011854
administration of an experimental agent for t1d at any time or use of an experimental device for t1d within 30 days prior to screening, unless approved by the medical monitor
Descrição

Investigational New Drug Insulin-Dependent Diabetes Mellitus | Investigational Medical Device Insulin-Dependent Diabetes Mellitus

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0011854
UMLS CUI [2,1]
C2346570
UMLS CUI [2,2]
C0011854
history of any organ transplant, including islet cell transplant
Descrição

Organ Transplantation | Islets of Langerhans Transplantation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0029216
UMLS CUI [2]
C0079646
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Similar models

Eligibility Diabetes NCT00453375

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00453375
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
diagnosis of type 1a diabetes mellitus based on ada criteria
boolean
C0011854 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus disease length
Item
≤5 years since t1d was diagnosed
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Age
Item
≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Age | Diabetes Mellitus, Insulin-Dependent
Item
≤ 40 years of age at the time of diagnosis of type 1a diabetes
boolean
C0001779 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
Antibodies Present
Item
presence of antibodies to at least one of the following antigens:
boolean
C0003241 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Insulin Antibodies | GAD-65 Antibodies | IA-2 Antibodies
Item
insulin, gad-65, or ia-2
boolean
C0021644 (UMLS CUI [1])
C0910436 (UMLS CUI [2,1])
C0003241 (UMLS CUI [2,2])
C0380315 (UMLS CUI [3,1])
C0003241 (UMLS CUI [3,2])
fasting C-peptide level Detectable
Item
detectable fasting c-peptide level
boolean
C2208720 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
Insulin C-peptide increased | Meal Mixed Tolerance test
Item
c-peptide increase during screening mixed meal tolerance test with a minimal stimulated value of ≥ 0.2 pmol/ml
boolean
C0861021 (UMLS CUI [1])
C1998602 (UMLS CUI [2,1])
C0205430 (UMLS CUI [2,2])
C0201777 (UMLS CUI [2,3])
Antibodies Present | Insulin Antibodies | GAD-65 Antibodies | IA-2 Antibodies
Item
presence of antibodies to at least one of the following antigens: insulin, gad-65, or ia-2. if insulin antibody positive only, determination must be within 2 weeks of insulin initiation
boolean
C0003241 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C0021644 (UMLS CUI [2])
C0910436 (UMLS CUI [3,1])
C0003241 (UMLS CUI [3,2])
C0380315 (UMLS CUI [4,1])
C0003241 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Body mass index
Item
bmi > 30 kg/m2
boolean
C1305855 (UMLS CUI [1])
Blood Glucose control Unstable | Hypoglycemia Severe Episode Quantity | Assistance Patient need for
Item
unstable blood sugar control defined as one or more episodes of severe hypoglycemia (defined as hypoglycemia that required the assistance of another person) within the last 30 days
boolean
C0005802 (UMLS CUI [1,1])
C0243148 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C0020615 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332189 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C1269765 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
Insulin Inhalation
Item
current use of inhalable insulin
boolean
C0021641 (UMLS CUI [1,1])
C0205535 (UMLS CUI [1,2])
Immunotherapy Insulin-Dependent Diabetes Mellitus
Item
previous immunotherapy for t1d
boolean
C0021083 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
Investigational New Drug Insulin-Dependent Diabetes Mellitus | Investigational Medical Device Insulin-Dependent Diabetes Mellitus
Item
administration of an experimental agent for t1d at any time or use of an experimental device for t1d within 30 days prior to screening, unless approved by the medical monitor
boolean
C0013230 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
C2346570 (UMLS CUI [2,1])
C0011854 (UMLS CUI [2,2])
Organ Transplantation | Islets of Langerhans Transplantation
Item
history of any organ transplant, including islet cell transplant
boolean
C0029216 (UMLS CUI [1])
C0079646 (UMLS CUI [2])
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