ID

17736

Beschreibung

Evaluation of a Diabetes Vaccine in Newly Diagnosed Diabetics; ODM derived from: https://clinicaltrials.gov/show/NCT00057499

Link

https://clinicaltrials.gov/show/NCT00057499

Stichworte

Versionen (1)
  1. 30.09.16 30.09.16 -
Hochgeladen am

30. September 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Insulin-dependent Diabetes Mellitus NCT00057499

Englisch

Eligibility Insulin-dependent Diabetes Mellitus NCT00057499

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with type 1 diabetes mellitus within 3 months prior to study entry
Beschreibung

Diabetes Mellitus, Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
positive for iaa, gad65, or ia2 antibodies or positive for gad65 or ia2 antibodies after 2 weeks of starting insulin treatment
Beschreibung

Anti-insulin autoantibody Positive | Serum Gad65 Auto Antibodies Test Positive | IA-2 antibody Positive | Insulin regime

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1275890
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C1255118
UMLS CUI [2,2]
C1514241
UMLS CUI [3,1]
C0528414
UMLS CUI [3,2]
C1514241
UMLS CUI [4]
C0557978
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of treatment with any oral hypoglycemic agent for more than 3 months
Beschreibung

Oral hypoglycemic

Datentyp

boolean

Alias
UMLS CUI [1]
C0359086
ongoing use of medications known to influence glucose tolerance
Beschreibung

Pharmaceutical Preparations Affecting glucose tolerance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0178665
history of immunosuppressive or steroid therapy for more than 3 months within the 2 years prior to study entry
Beschreibung

Therapeutic immunosuppression | Steroid therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0149783
severe active liver, heart, kidney, or immunodeficiency disease that may limit life expectancy or may require immunosuppression during the study
Beschreibung

Liver disease Severe Limiting Life Expectancy | Heart Disease Severe Limiting Life Expectancy | Kidney Disease Severe Limiting Life Expectancy | Immunologic Deficiency Syndrome Severe Limiting Life Expectancy | Liver disease Severe Requirement Therapeutic immunosuppression | Heart Disease Severe Requirement Therapeutic immunosuppression | Kidney Disease Severe Requirement Therapeutic immunosuppression | Immunologic Deficiency Syndrome Severe Requirement Therapeutic immunosuppression

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C0023671
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0439801
UMLS CUI [2,4]
C0023671
UMLS CUI [3,1]
C0022658
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0439801
UMLS CUI [3,4]
C0023671
UMLS CUI [4,1]
C0021051
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0439801
UMLS CUI [4,4]
C0023671
UMLS CUI [5,1]
C0023895
UMLS CUI [5,2]
C0205082
UMLS CUI [5,3]
C1514873
UMLS CUI [5,4]
C0021079
UMLS CUI [6,1]
C0018799
UMLS CUI [6,2]
C0205082
UMLS CUI [6,3]
C1514873
UMLS CUI [6,4]
C0021079
UMLS CUI [7,1]
C0022658
UMLS CUI [7,2]
C0205082
UMLS CUI [7,3]
C1514873
UMLS CUI [7,4]
C0021079
UMLS CUI [8,1]
C0021051
UMLS CUI [8,2]
C0205082
UMLS CUI [8,3]
C1514873
UMLS CUI [8,4]
C0021079
prior complications related to routine vaccinations
Beschreibung

Complication of vaccination

Datentyp

boolean

Alias
UMLS CUI [1]
C0274430
prior participation in a trial for prevention of type 1 diabetes mellitus. individuals who are known to have been in the placebo arm of a completed prevention trial are not excluded.
Beschreibung

Study Subject Participation Status | Insulin-Dependent Diabetes Mellitus Prevention

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0011854
UMLS CUI [2,2]
C0199176
any condition that may interfere with a participant's ability to comply with the study
Beschreibung

Condition Interferes with Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
pregnancy or planned pregnancy within the time frame of the study
Beschreibung

Pregnancy | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Insulin-dependent Diabetes Mellitus NCT00057499

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
diagnosed with type 1 diabetes mellitus within 3 months prior to study entry
boolean
C0011854 (UMLS CUI [1])
Anti-insulin autoantibody Positive | Serum Gad65 Auto Antibodies Test Positive | IA-2 antibody Positive | Insulin regime
Item
positive for iaa, gad65, or ia2 antibodies or positive for gad65 or ia2 antibodies after 2 weeks of starting insulin treatment
boolean
C1275890 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C1255118 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0528414 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C0557978 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Oral hypoglycemic
Item
history of treatment with any oral hypoglycemic agent for more than 3 months
boolean
C0359086 (UMLS CUI [1])
Pharmaceutical Preparations Affecting glucose tolerance
Item
ongoing use of medications known to influence glucose tolerance
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0178665 (UMLS CUI [1,3])
Therapeutic immunosuppression | Steroid therapy
Item
history of immunosuppressive or steroid therapy for more than 3 months within the 2 years prior to study entry
boolean
C0021079 (UMLS CUI [1])
C0149783 (UMLS CUI [2])
Liver disease Severe Limiting Life Expectancy | Heart Disease Severe Limiting Life Expectancy | Kidney Disease Severe Limiting Life Expectancy | Immunologic Deficiency Syndrome Severe Limiting Life Expectancy | Liver disease Severe Requirement Therapeutic immunosuppression | Heart Disease Severe Requirement Therapeutic immunosuppression | Kidney Disease Severe Requirement Therapeutic immunosuppression | Immunologic Deficiency Syndrome Severe Requirement Therapeutic immunosuppression
Item
severe active liver, heart, kidney, or immunodeficiency disease that may limit life expectancy or may require immunosuppression during the study
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0023671 (UMLS CUI [1,4])
C0018799 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0023671 (UMLS CUI [2,4])
C0022658 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C0023671 (UMLS CUI [3,4])
C0021051 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
C0023671 (UMLS CUI [4,4])
C0023895 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C1514873 (UMLS CUI [5,3])
C0021079 (UMLS CUI [5,4])
C0018799 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C1514873 (UMLS CUI [6,3])
C0021079 (UMLS CUI [6,4])
C0022658 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C1514873 (UMLS CUI [7,3])
C0021079 (UMLS CUI [7,4])
C0021051 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C1514873 (UMLS CUI [8,3])
C0021079 (UMLS CUI [8,4])
Complication of vaccination
Item
prior complications related to routine vaccinations
boolean
C0274430 (UMLS CUI [1])
Study Subject Participation Status | Insulin-Dependent Diabetes Mellitus Prevention
Item
prior participation in a trial for prevention of type 1 diabetes mellitus. individuals who are known to have been in the placebo arm of a completed prevention trial are not excluded.
boolean
C2348568 (UMLS CUI [1])
C0011854 (UMLS CUI [2,1])
C0199176 (UMLS CUI [2,2])
Condition Interferes with Protocol Compliance
Item
any condition that may interfere with a participant's ability to comply with the study
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Pregnancy | Pregnancy, Planned
Item
pregnancy or planned pregnancy within the time frame of the study
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video