ID

23077

Description

A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00396565

Link

https://clinicaltrials.gov/show/NCT00396565

Keywords

  1. 6/22/17 6/22/17 -
Uploaded on

June 22, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Schizophrenia NCT00396565

Eligibility Schizophrenia NCT00396565

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who have given their own consent in writing to participate in the study
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients diagnosed with schizophrenia according to the diagnostic criteria of dsm-iv (diagnostic and statistical manual of mental disorders, 295.30, 295.10, 295.20, 295.90, 295.60)
Description

Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0036341
patients who have acute symptoms of schizophrenia
Description

Schizophrenia Symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C1457887
both inpatients and outpatients are acceptable
Description

Inpatient | Outpatients

Data type

boolean

Alias
UMLS CUI [1]
C0021562
UMLS CUI [2]
C0029921
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
a dsm-iv (diagnostic and statistical manual of mental disorders) of a mental disease diagnosis other than schizophrenia
Description

Mental disorders | Schizophrenia Excluded

Data type

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2,1]
C0036341
UMLS CUI [2,2]
C2828389
a dsm-iv diagnosis of substance-related disorder (except nicotine dependence and caffeine dependence) within 180 days before the screening test
Description

Substance Use Disorders | Nicotine Dependence Excluded | Caffeine dependence Excluded

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0028043
UMLS CUI [2,2]
C2828389
UMLS CUI [3,1]
C1386553
UMLS CUI [3,2]
C2828389
total panss (positive and negative syndrome system) score at the screening test <70 or >120
Description

Positive and negative syndrome scale

Data type

boolean

Alias
UMLS CUI [1]
C0451383
patients treated with three or more types of antipsychotic within 28 days before the screening test
Description

Antipsychotic Agents Type Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1265611
parkinson's disease (except for those with drug-induced extra pyramidal symptoms)
Description

Parkinson Disease | Extrapyramidal symptoms Drug-induced Excluded

Data type

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2,1]
C0234133
UMLS CUI [2,2]
C0458082
UMLS CUI [2,3]
C2828389
patients with a complication of or a past history of cerebrovascular accident
Description

Cerebrovascular accident Complication

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0009566
patients with a complication of or a past history of diabetes mellitus
Description

Complications of Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0342257

Similar models

Eligibility Schizophrenia NCT00396565

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
patients who have given their own consent in writing to participate in the study
boolean
C0021430 (UMLS CUI [1])
Schizophrenia
Item
patients diagnosed with schizophrenia according to the diagnostic criteria of dsm-iv (diagnostic and statistical manual of mental disorders, 295.30, 295.10, 295.20, 295.90, 295.60)
boolean
C0036341 (UMLS CUI [1])
Schizophrenia Symptoms
Item
patients who have acute symptoms of schizophrenia
boolean
C0036341 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Inpatient | Outpatients
Item
both inpatients and outpatients are acceptable
boolean
C0021562 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Mental disorders | Schizophrenia Excluded
Item
a dsm-iv (diagnostic and statistical manual of mental disorders) of a mental disease diagnosis other than schizophrenia
boolean
C0004936 (UMLS CUI [1])
C0036341 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Substance Use Disorders | Nicotine Dependence Excluded | Caffeine dependence Excluded
Item
a dsm-iv diagnosis of substance-related disorder (except nicotine dependence and caffeine dependence) within 180 days before the screening test
boolean
C0038586 (UMLS CUI [1])
C0028043 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C1386553 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
Positive and negative syndrome scale
Item
total panss (positive and negative syndrome system) score at the screening test <70 or >120
boolean
C0451383 (UMLS CUI [1])
Antipsychotic Agents Type Quantity
Item
patients treated with three or more types of antipsychotic within 28 days before the screening test
boolean
C0040615 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Parkinson Disease | Extrapyramidal symptoms Drug-induced Excluded
Item
parkinson's disease (except for those with drug-induced extra pyramidal symptoms)
boolean
C0030567 (UMLS CUI [1])
C0234133 (UMLS CUI [2,1])
C0458082 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
Cerebrovascular accident Complication
Item
patients with a complication of or a past history of cerebrovascular accident
boolean
C0038454 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
Complications of Diabetes Mellitus
Item
patients with a complication of or a past history of diabetes mellitus
boolean
C0342257 (UMLS CUI [1])

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