ID

4866

Description

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

Link

http://clinicaltrials.gov/show/NCT00214578

Keywords

Versions (2)
  1. 12/27/11 12/27/11 -
  2. 4/13/14 4/13/14 - Julian Varghese
Uploaded on

April 13, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00214578 Schizophrenia

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Age 18 Years to 65 Years
Description

Age

Data type

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.
Description

Schizophrenia requiring a change in treatment

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

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

Diabetes mellitus

Data type

boolean

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

Other medications

Data type

boolean

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

Contraindications

Data type

boolean

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

Non-Compliance

Data type

boolean

Medical Concepts
Description

Medical Concepts

Age
Description

Age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Schizophrenic disorders
Description

Schizophrenia

Data type

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
Treatment changed
Description

Treatment changed

Data type

string

Alias
UMLS CUI
C2919691
SNOMED CT 2010_0731
445528004
Effectiveness
Description

Efficacy

Data type

string

Alias
UMLS CUI
C1280519
SNOMED CT 2010_0731
255403003
Informed Consent
Description

Informed Consent

Data type

string

Alias
UMLS CUI
C0021430
Diabetes mellitus
Description

Diabetes mellitus

Data type

string

Alias
UMLS CUI
C0011849
SNOMED CT 2010_0731
191044006
Hemoglobin A1c (HbA1c)
Description

Glycosylated hemoglobin A

Data type

string

Alias
UMLS CUI
C0019018
SNOMED CT 2010_0731
33601001
LOINC Version 232
MTHU018890
Oral Glucose Tolerance Test (OGTT)
Description

Oral Glucose Tolerance

Data type

string

Alias
UMLS CUI
C0029161
Plasma fasting glucose level
Description

Plasma fasting glucose measurement

Data type

string

Alias
UMLS CUI
C0583513
SNOMED CT 2010_0731
167096006
Medication
Description

Pharmaceutical Preparations

Data type

string

Alias
UMLS CUI
C0013227
Treatment noncompliance
Description

Treatment noncompliance

Data type

string

Alias
UMLS CUI
C0376405
MedDRA 13.1
10049414
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Age
Item
Age 18 Years to 65 Years
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
Item Group
Exclusion Criteria
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
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Schizophrenia
Item
Schizophrenic disorders
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
Treatment changed
string
C2919691 (UMLS CUI)
445528004 (SNOMED CT 2010_0731)
Efficacy
Item
Effectiveness
string
C1280519 (UMLS CUI)
255403003 (SNOMED CT 2010_0731)
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
Diabetes mellitus
Item
Diabetes mellitus
string
C0011849 (UMLS CUI)
191044006 (SNOMED CT 2010_0731)
Glycosylated hemoglobin A
Item
Hemoglobin A1c (HbA1c)
string
C0019018 (UMLS CUI)
33601001 (SNOMED CT 2010_0731)
MTHU018890 (LOINC Version 232)
Oral Glucose Tolerance
Item
Oral Glucose Tolerance Test (OGTT)
string
C0029161 (UMLS CUI)
Plasma fasting glucose measurement
Item
Plasma fasting glucose level
string
C0583513 (UMLS CUI)
167096006 (SNOMED CT 2010_0731)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Treatment noncompliance
Item
Treatment noncompliance
string
C0376405 (UMLS CUI)
10049414 (MedDRA 13.1)
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