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Eligibility Schizophrenia NCT00810667

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
primary diagnosis of schizophrenia
Description

Schizophrenia Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0205225
man or woman, aged between 18-65
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient is on an optimised dose of risperidone (within 4-8 mg/day) for the treatment of schizophrenia for a minimum of 4 weeks prior to screening
Description

Risperidone Dose U/day | Therapy Schizophrenia

Data type

boolean

Alias
UMLS CUI [1,1]
C0073393
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0036341
the patient has a panss total score between 70 and 100 (extremes included) at screening
Description

PANSS

Data type

boolean

Alias
UMLS CUI [1]
C4086747
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
primary psychiatric diagnosis other than schizophrenia
Description

Psychiatric Diagnosis Primary | Eception Schizophrenia

Data type

boolean

Alias
UMLS CUI [1,1]
C0376338
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036341
acute exacerbation requiring hospitalisation within the last 3 months
Description

Acute exacerbation Hospitalization Required

Data type

boolean

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

Extrapyramidal symptoms

Data type

boolean

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

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

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0018802
UMLS CUI [3]
C1383860
UMLS CUI [4]
C0003811
UMLS CUI [5]
C0428977
significant ecg abnormalities
Description

ECG abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0522055
in concurrent treatment with drugs inhibiting the p450 enzymes system cyp2d6 and other cyp isozymes
Description

CYP2D6 Inhibitors | Cytochrome P450 Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C3850058
UMLS CUI [2,1]
C0010762
UMLS CUI [2,2]
C0243077
failed to respond to adequate courses of treatment with risperidone
Description

Risperidone Courses failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0073393
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C0231175
treated with an antipsychotic other than risperidone within 4 weeks prior to screening
Description

Antipsychotic Agent | Exception Risperidone

Data type

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0073393
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Similar models

Eligibility Schizophrenia NCT00810667

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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 18-65
boolean
C0001779 (UMLS CUI [1])
Risperidone Dose U/day | Therapy Schizophrenia
Item
patient is on an optimised dose of risperidone (within 4-8 mg/day) for the treatment of schizophrenia for a minimum of 4 weeks prior to screening
boolean
C0073393 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
PANSS
Item
the patient has a panss total score between 70 and 100 (extremes included) at screening
boolean
C4086747 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Psychiatric Diagnosis Primary | Eception Schizophrenia
Item
primary psychiatric diagnosis other than schizophrenia
boolean
C0376338 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
Acute exacerbation Hospitalization Required
Item
acute exacerbation requiring hospitalisation within the last 3 months
boolean
C0743630 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
Extrapyramidal symptoms
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])
ECG abnormal
Item
significant ecg abnormalities
boolean
C0522055 (UMLS CUI [1])
CYP2D6 Inhibitors | Cytochrome P450 Inhibitors
Item
in concurrent treatment with drugs inhibiting the p450 enzymes system cyp2d6 and other cyp isozymes
boolean
C3850058 (UMLS CUI [1])
C0010762 (UMLS CUI [2,1])
C0243077 (UMLS CUI [2,2])
Risperidone Courses failed
Item
failed to respond to adequate courses of treatment with risperidone
boolean
C0073393 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Antipsychotic Agent | Exception Risperidone
Item
treated with an antipsychotic other than risperidone within 4 weeks prior to screening
boolean
C0040615 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0073393 (UMLS CUI [2,2])
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