ID

4866

Description

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

Lien

http://clinicaltrials.gov/show/NCT00214578

Mots-clés

  1. 27/12/2011 27/12/2011 -
  2. 13/04/2014 13/04/2014 - Julian Varghese
Téléchargé le

13 avril 2014

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

Modèle Commentaires :

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Eligibility NCT00214578 Schizophrenia

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alter 18 bis 65 Jahre
Description

Age

Type de données

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

Type de données

boolean

Exclusion Criteria
Description

Exclusion Criteria

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

Diabetes mellitus

Type de données

boolean

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

Other medications

Type de données

boolean

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

Contraindications

Type de données

boolean

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

Non-Compliance

Type de données

boolean

Medical Concepts
Description

Medical Concepts

Alter
Description

Age

Type de données

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnose
Description

Diagnosis

Type de données

string

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

Schizophrenia

Type de données

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
Description

Treatment changed

Type de données

string

Alias
UMLS CUI
C2919691
SNOMED CT 2010_0731
445528004
Effectiveness
Description

Efficacy

Type de données

string

Alias
UMLS CUI
C1280519
SNOMED CT 2010_0731
255403003
Einverständniserklärung
Description

Informed Consent

Type de données

string

Alias
UMLS CUI
C0021430
Diabetes mellitus
Description

Diabetes mellitus

Type de données

string

Alias
UMLS CUI
C0011849
SNOMED CT 2010_0731
191044006
HbA1c
Description

Glycosylated hemoglobin A

Type de données

string

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

Oral Glucose Tolerance

Type de données

string

Alias
UMLS CUI
C0029161
Nüchternblutzucker im Plasma
Description

Plasma fasting glucose measurement

Type de données

string

Alias
UMLS CUI
C0583513
SNOMED CT 2010_0731
167096006
Medikation
Description

Pharmaceutical Preparations

Type de données

string

Alias
UMLS CUI
C0013227
Treatment noncompliance
Description

Treatment noncompliance

Type de données

string

Alias
UMLS CUI
C0376405
MedDRA 13.1
10049414

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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)

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