ID

23077

Descripción

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

Palabras clave

Versiones (1)
  1. 22/6/17 22/6/17 -
Subido en

22 de junio de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00396565

Inglés

Eligibility Schizophrenia NCT00396565

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Informed Consent

Tipo de datos

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)
Descripción

Schizophrenia

Tipo de datos

boolean

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

Schizophrenia Symptoms

Tipo de datos

boolean

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

Inpatient | Outpatients

Tipo de datos

boolean

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

Exclusion Criteria

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

Mental disorders | Schizophrenia Excluded

Tipo de datos

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
Descripción

Substance Use Disorders | Nicotine Dependence Excluded | Caffeine dependence Excluded

Tipo de datos

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
Descripción

Positive and negative syndrome scale

Tipo de datos

boolean

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

Antipsychotic Agents Type Quantity

Tipo de datos

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)
Descripción

Parkinson Disease | Extrapyramidal symptoms Drug-induced Excluded

Tipo de datos

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
Descripción

Cerebrovascular accident Complication

Tipo de datos

boolean

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

Complications of Diabetes Mellitus

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0342257
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Similar models

Eligibility Schizophrenia NCT00396565

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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