ID

137

Beskrivning

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

Länk

http://clinicaltrials.gov/show/NCT00214578

Nyckelord

Versioner (2)
  1. 2011-12-27 2011-12-27 -
  2. 2014-04-13 2014-04-13 - Julian Varghese
Uppladdad den

27 december 2011

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00214578 Schizophrenia

Tysk Engelsk

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alter 18 bis 65 Jahre
Beskrivning

Age

Datatyp

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.
Beskrivning

Schizophrenia requiring a change in treatment

Datatyp

boolean

Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Diabetes mellitus

Datatyp

boolean

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

Other medications

Datatyp

boolean

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

Contraindications

Datatyp

boolean

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

Non-Compliance

Datatyp

boolean

Medical Concepts
Beskrivning

Medical Concepts

Alter
Beskrivning

Age

Datatyp

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnose
Beskrivning

Diagnosis

Datatyp

string

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

Schizophrenia

Datatyp

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
Beskrivning

Treatment changed

Datatyp

string

Alias
UMLS CUI
C2919691
SNOMED CT 2010_0731
445528004
Effectiveness
Beskrivning

Efficacy

Datatyp

string

Alias
UMLS CUI
C1280519
SNOMED CT 2010_0731
255403003
Einverständniserklärung
Beskrivning

Informed Consent

Datatyp

string

Alias
UMLS CUI
C0021430
Diabetes mellitus
Beskrivning

Diabetes mellitus

Datatyp

string

Alias
UMLS CUI
C0011849
SNOMED CT 2010_0731
191044006
HbA1c
Beskrivning

Glycosylated hemoglobin A

Datatyp

string

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

Oral Glucose Tolerance

Datatyp

string

Alias
UMLS CUI
C0029161
Nüchternblutzucker im Plasma
Beskrivning

Plasma fasting glucose measurement

Datatyp

string

Alias
UMLS CUI
C0583513
SNOMED CT 2010_0731
167096006
Medikation
Beskrivning

Pharmaceutical Preparations

Datatyp

string

Alias
UMLS CUI
C0013227
Treatment noncompliance
Beskrivning

Treatment noncompliance

Datatyp

string

Alias
UMLS CUI
C0376405
MedDRA 13.1
10049414
Tillbaka till toppen

Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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)
Tillbaka till toppen 

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