ID

32639

Description

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

Keywords

Versions (2)
  1. 11/9/18 11/9/18 -
  2. 11/9/18 11/9/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 9, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Type 1 Diabetes Mellitus NCT00723411

English

Eligibility Type 1 Diabetes Mellitus NCT00723411

1 forms  
Criteria
Description

Criteria

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

Age

Data type

boolean

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

Insulin-Dependent Diabetes Mellitus Disease length

Data type

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
Description

Fasting C-peptide level

Data type

boolean

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

Serum Gad65 Auto Antibodies Test Elevated

Data type

boolean

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

Exclusion Criteria Main

Data type

boolean

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

Immunosuppressive Agents | Antidiabetics | Exception Insulin

Data type

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)
Description

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

Data type

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
Description

Vaccination | Exception Influenza vaccine

Data type

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
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

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

Pregnancy | Pregnancy, Planned

Data type

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
Description

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

Data type

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
Back to the top of the page

Similar models

Eligibility Type 1 Diabetes Mellitus NCT00723411

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
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])
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial