ID

32643

Descrição

A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (EU); ODM derived from: https://clinicaltrials.gov/show/NCT00723411

Link

https://clinicaltrials.gov/show/NCT00723411

Palavras-chave

Versões (2)
  1. 09/11/2018 09/11/2018 -
  2. 09/11/2018 09/11/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

9 de novembro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Type 1 Diabetes Mellitus NCT00723411

Inglês

Eligibility Type 1 Diabetes Mellitus NCT00723411

1 Formulários  
Criteria
Descrição

Criteria

male and female patients between 10 and 20 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
insulin dependent type 1 diabetes mellitus diagnosed within the previous 3 months at time of screening
Descrição

Insulin-Dependent Diabetes Mellitus Disease length

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
fasting c-peptide level at time of screening above 0.1 nmol/l
Descrição

Fasting C-peptide level

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2208720
elevated gad65 antibodies (gada) at time of screening
Descrição

Serum Gad65 Auto Antibodies Test Elevated

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1255118
UMLS CUI [1,2]
C3163633
main exclusion criteria:
Descrição

Exclusion Criteria Main

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
treatment with immunosuppressants or any anti-diabetic medications other than insulin
Descrição

Immunosuppressive Agents | Antidiabetics | Exception Insulin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0935929
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0021641
a history of certain diseases or conditions (e.g. anemia, hiv, hepatitis, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc)
Descrição

Anemia | HIV Infection | Hepatitis | Epilepsy | Craniocerebral Trauma | Nervous system disorder | Cerebrovascular accident | Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0019158
UMLS CUI [4]
C0014544
UMLS CUI [5]
C0018674
UMLS CUI [6]
C0027765
UMLS CUI [7]
C0038454
UMLS CUI [8]
C0038586
treatment with any vaccine within 1 month prior to planned first diamyd dose or planned treatment with vaccine up to 2 months after the last injection with diamyd, excluding the influenza vaccine
Descrição

Vaccination | Exception Influenza vaccine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0042196
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0021403
participation in other clinical trials with a new chemical entity within the previous 3 months
Descrição

Study Subject Participation Status | Investigational New Drugs Chemical

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0220806
pregnancy or planned pregnancy within 1 year after the last diamyd dose
Descrição

Pregnancy | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
Descrição

Disease Serious Study Subject Participation Status Ineligible | Condition Serious Study Subject Participation Status Ineligible

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C1512714
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C1512714
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Similar models

Eligibility Type 1 Diabetes Mellitus NCT00723411

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Age
Item
male and female patients between 10 and 20 years of age
boolean
C0001779 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus Disease length
Item
insulin dependent type 1 diabetes mellitus diagnosed within the previous 3 months at time of screening
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Fasting C-peptide level
Item
fasting c-peptide level at time of screening above 0.1 nmol/l
boolean
C2208720 (UMLS CUI [1])
Serum Gad65 Auto Antibodies Test Elevated
Item
elevated gad65 antibodies (gada) at time of screening
boolean
C1255118 (UMLS CUI [1,1])
C3163633 (UMLS CUI [1,2])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Immunosuppressive Agents | Antidiabetics | Exception Insulin
Item
treatment with immunosuppressants or any anti-diabetic medications other than insulin
boolean
C0021081 (UMLS CUI [1])
C0935929 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0021641 (UMLS CUI [3,2])
Anemia | HIV Infection | Hepatitis | Epilepsy | Craniocerebral Trauma | Nervous system disorder | Cerebrovascular accident | Substance Use Disorders
Item
a history of certain diseases or conditions (e.g. anemia, hiv, hepatitis, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc)
boolean
C0002871 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0019158 (UMLS CUI [3])
C0014544 (UMLS CUI [4])
C0018674 (UMLS CUI [5])
C0027765 (UMLS CUI [6])
C0038454 (UMLS CUI [7])
C0038586 (UMLS CUI [8])
Vaccination | Exception Influenza vaccine
Item
treatment with any vaccine within 1 month prior to planned first diamyd dose or planned treatment with vaccine up to 2 months after the last injection with diamyd, excluding the influenza vaccine
boolean
C0042196 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0021403 (UMLS CUI [2,2])
Study Subject Participation Status | Investigational New Drugs Chemical
Item
participation in other clinical trials with a new chemical entity within the previous 3 months
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0220806 (UMLS CUI [2,2])
Pregnancy | Pregnancy, Planned
Item
pregnancy or planned pregnancy within 1 year after the last diamyd dose
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Disease Serious Study Subject Participation Status Ineligible | Condition Serious Study Subject Participation Status Ineligible
Item
presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1512714 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1512714 (UMLS CUI [2,4])
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