ID

44279

Beskrivning

Efficacy Study Exploring the Effects on Cognition of Sertindole Versus Comparator in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00654706

Länk

https://clinicaltrials.gov/show/NCT00654706

Nyckelord

  1. 2018-10-22 2018-10-22 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 september 2021

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Schizophrenia NCT00654706

Eligibility Schizophrenia NCT00654706

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
primary diagnosis of schizophrenia
Beskrivning

Schizophrenia Primary

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0205225
man or woman, aged between 18 and 55 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
current axis i primary psychiatric diagnosis other than schizophrenia
Beskrivning

Axis I diagnosis Primary | Exception Schizophrenia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036341
not previously received antipsychotic drugs for schizophrenia
Beskrivning

Antipsychotic Agents Absent Schizophrenia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0036341
acute exacerbation requiring hospitalisation within the last 3 months
Beskrivning

Exacerbation acute Hospitalization Required

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0743630
UMLS CUI [1,2]
C1708385
clinically significant extrapyramidal symptoms
Beskrivning

Extrapyramidal sign

Datatyp

boolean

Alias
UMLS CUI [1]
C0234133
clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia
Beskrivning

Cardiovascular Disease | Congestive heart failure | Cardiac Hypertrophy | Cardiac Arrhythmia | Bradycardia

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0018802
UMLS CUI [3]
C1383860
UMLS CUI [4]
C0003811
UMLS CUI [5]
C0428977
congenital long qt syndrome or a family history of this disease, or known acquired qt interval prolongation
Beskrivning

Congenital long QT syndrome | Family history Congenital long QT syndrome | Prolonged QT interval Acquired

Datatyp

boolean

Alias
UMLS CUI [1]
C1141890
UMLS CUI [2,1]
C0241889
UMLS CUI [2,2]
C1141890
UMLS CUI [3,1]
C0151878
UMLS CUI [3,2]
C0439661
significant ecg abnormalities
Beskrivning

ECG abnormality

Datatyp

boolean

Alias
UMLS CUI [1]
C0522055
hypokalaemia or hypomagnesaemia
Beskrivning

Hypokalemia | Hypomagnesemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0020621
UMLS CUI [2]
C0151723
in concurrent treatment with drugs inhibiting the p450 enzymes system cyp3a
Beskrivning

CYP3A Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C3850056

Similar models

Eligibility Schizophrenia NCT00654706

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia Primary
Item
primary diagnosis of schizophrenia
boolean
C0036341 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Age
Item
man or woman, aged between 18 and 55 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis Primary | Exception Schizophrenia
Item
current axis i primary psychiatric diagnosis other than schizophrenia
boolean
C0270287 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
Antipsychotic Agents Absent Schizophrenia
Item
not previously received antipsychotic drugs for schizophrenia
boolean
C0040615 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,3])
Exacerbation acute Hospitalization Required
Item
acute exacerbation requiring hospitalisation within the last 3 months
boolean
C0743630 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
Extrapyramidal sign
Item
clinically significant extrapyramidal symptoms
boolean
C0234133 (UMLS CUI [1])
Cardiovascular Disease | Congestive heart failure | Cardiac Hypertrophy | Cardiac Arrhythmia | Bradycardia
Item
clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia
boolean
C0007222 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C1383860 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
C0428977 (UMLS CUI [5])
Congenital long QT syndrome | Family history Congenital long QT syndrome | Prolonged QT interval Acquired
Item
congenital long qt syndrome or a family history of this disease, or known acquired qt interval prolongation
boolean
C1141890 (UMLS CUI [1])
C0241889 (UMLS CUI [2,1])
C1141890 (UMLS CUI [2,2])
C0151878 (UMLS CUI [3,1])
C0439661 (UMLS CUI [3,2])
ECG abnormality
Item
significant ecg abnormalities
boolean
C0522055 (UMLS CUI [1])
Hypokalemia | Hypomagnesemia
Item
hypokalaemia or hypomagnesaemia
boolean
C0020621 (UMLS CUI [1])
C0151723 (UMLS CUI [2])
CYP3A Inhibitors
Item
in concurrent treatment with drugs inhibiting the p450 enzymes system cyp3a
boolean
C3850056 (UMLS CUI [1])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial