ID

137

Beschrijving

ODM derived from http://clinicaltrials.gov/show/NCT00214578

Link

http://clinicaltrials.gov/show/NCT00214578

Trefwoorden

Versies (2)
  1. 27-12-11 27-12-11 -
  2. 13-04-14 13-04-14 - Julian Varghese
Geüploaded op

27 december 2011

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00214578 Schizophrenia

Duits Engels

Eligibility

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alter 18 bis 65 Jahre
Beschrijving

Age

Datatype

boolean

In- or outpatients with schizophrenia, 18-65 years old, requiring a change in treatment due to insufficient efficacy or tolerability and giving signed informed consent.
Beschrijving

Schizophrenia requiring a change in treatment

Datatype

boolean

Exclusion Criteria
Beschrijving

Exclusion Criteria

Known diabetes mellitus, high HbA1c, fasting plasma glucose and/or high 2h glucose-OGTT
Beschrijving

Diabetes mellitus

Datatype

boolean

Previous use of atypicals (3 months) or other medications that might influence glucose metabolism
Beschrijving

Other medications

Datatype

boolean

Contraindications or non-responsiveness for any of the treatments or other safety issues
Beschrijving

Contraindications

Datatype

boolean

Expected non-compliance to treatment and/or study procedures
Beschrijving

Non-Compliance

Datatype

boolean

Medical Concepts
Beschrijving

Medical Concepts

Alter
Beschrijving

Age

Datatype

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnose
Beschrijving

Diagnosis

Datatype

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Schizophrenie
Beschrijving

Schizophrenia

Datatype

string

Alias
UMLS CUI
C0036341
SNOMED CT 2010_0731
58214004
MedDRA 13.1
10039626
LOINC Version 232
MTHU020814
ICD-10-CM Version 2010
F20
ICD-9-CM Version 2011
295
Änderung der Therapie
Beschrijving

Treatment changed

Datatype

string

Alias
UMLS CUI
C2919691
SNOMED CT 2010_0731
445528004
Effectiveness
Beschrijving

Efficacy

Datatype

string

Alias
UMLS CUI
C1280519
SNOMED CT 2010_0731
255403003
Einverständniserklärung
Beschrijving

Informed Consent

Datatype

string

Alias
UMLS CUI
C0021430
Diabetes mellitus
Beschrijving

Diabetes mellitus

Datatype

string

Alias
UMLS CUI
C0011849
SNOMED CT 2010_0731
191044006
HbA1c
Beschrijving

Glycosylated hemoglobin A

Datatype

string

Alias
UMLS CUI
C0019018
SNOMED CT 2010_0731
33601001
LOINC Version 232
MTHU018890
Oraler Glukose-Toleranztest
Beschrijving

Oral Glucose Tolerance

Datatype

string

Alias
UMLS CUI
C0029161
Nüchternblutzucker im Plasma
Beschrijving

Plasma fasting glucose measurement

Datatype

string

Alias
UMLS CUI
C0583513
SNOMED CT 2010_0731
167096006
Medikation
Beschrijving

Pharmaceutical Preparations

Datatype

string

Alias
UMLS CUI
C0013227
Treatment noncompliance
Beschrijving

Treatment noncompliance

Datatype

string

Alias
UMLS CUI
C0376405
MedDRA 13.1
10049414
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Similar models

Eligibility

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Age
Item
Alter 18 bis 65 Jahre
boolean
Schizophrenia requiring a change in treatment
Item
In- or outpatients with schizophrenia, 18-65 years old, requiring a change in treatment due to insufficient efficacy or tolerability and giving signed informed consent.
boolean
Diabetes mellitus
Item
Known diabetes mellitus, high HbA1c, fasting plasma glucose and/or high 2h glucose-OGTT
boolean
Other medications
Item
Previous use of atypicals (3 months) or other medications that might influence glucose metabolism
boolean
Contraindications
Item
Contraindications or non-responsiveness for any of the treatments or other safety issues
boolean
Non-Compliance
Item
Expected non-compliance to treatment and/or study procedures
boolean
Age
Item
Alter
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnose
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Schizophrenia
Item
Schizophrenie
string
C0036341 (UMLS CUI)
58214004 (SNOMED CT 2010_0731)
10039626 (MedDRA 13.1)
MTHU020814 (LOINC Version 232)
F20 (ICD-10-CM Version 2010)
295 (ICD-9-CM Version 2011)
Treatment changed
Item
Änderung der Therapie
string
C2919691 (UMLS CUI)
445528004 (SNOMED CT 2010_0731)
Efficacy
Item
Effectiveness
string
C1280519 (UMLS CUI)
255403003 (SNOMED CT 2010_0731)
Informed Consent
Item
Einverständniserklärung
string
C0021430 (UMLS CUI)
Diabetes mellitus
Item
Diabetes mellitus
string
C0011849 (UMLS CUI)
191044006 (SNOMED CT 2010_0731)
Glycosylated hemoglobin A
Item
HbA1c
string
C0019018 (UMLS CUI)
33601001 (SNOMED CT 2010_0731)
MTHU018890 (LOINC Version 232)
Oral Glucose Tolerance
Item
Oraler Glukose-Toleranztest
string
C0029161 (UMLS CUI)
Plasma fasting glucose measurement
Item
Nüchternblutzucker im Plasma
string
C0583513 (UMLS CUI)
167096006 (SNOMED CT 2010_0731)
Pharmaceutical Preparations
Item
Medikation
string
C0013227 (UMLS CUI)
Treatment noncompliance
Item
Treatment noncompliance
string
C0376405 (UMLS CUI)
10049414 (MedDRA 13.1)
Terug naar het begin van de pagina 

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