ID

32266

Descrição

A Pharmacokinetic and Safety Study of Paliperidone Palmitate (JNS010) in Participants With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01606254

Link

https://clinicaltrials.gov/show/NCT01606254

Palavras-chave

Versões (1)
  1. 25/10/2018 25/10/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

25 de outubro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01606254

Inglês

Eligibility Schizophrenia NCT01606254

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants who have been diagnosed with schizophrenia in accordance with the diagnostic criteria of diagnostic and statistical manual of mental disorders 4th edition (dsm-iv)
Descrição

Schizophrenia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0036341
participants may be inpatients or outpatients
Descrição

Inpatient | Outpatients

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021562
UMLS CUI [2]
C0029921
participants who have been taking an oral antipsychotic medication for at least 28 days before the date of informed consent
Descrição

Antipsychotic Agents Oral

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C1527415
participants with a positive and negative syndrome scale (panss) score of less than or equal to 4 (moderate) at screening
Descrição

PANSS

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4086747
participants who have taken risperidone by the start of investigational treatment and the record can be confirmed exclusion criteria
Descrição

Risperidone

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0073393
participants who have been diagnosed with a mental disease other than schizophrenia in accordance with the diagnostic criteria of diagnostic and statistical manual of mental disorders 4th edition (dsm-iv)
Descrição

Mental disorders | Exception Schizophrenia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036341
participants who have been diagnosed with substance-related disorders (except nicotine and caffeine dependence)
Descrição

Substance Use Disorders | Exception Nicotine Dependence | Exception Caffeine dependence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0028043
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1386553
participants with complicated parkinson's disease (a progressive disorder of the central nervous system, seen usually in older persons, in which there is muscle weakness, trembling and sweating)
Descrição

Parkinson Disease Complication

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0009566
participants with a complication of or with a history of convulsive disease such as epilepsy (seizure disorder)
Descrição

Convulsive disorder Complication | Epilepsy Complication

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0234972
UMLS CUI [1,2]
C0009566
UMLS CUI [2,1]
C0014544
UMLS CUI [2,2]
C0009566
participants with a complication of or with a history of cerebro-vascular accident (stroke), neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness) or physical exhaustion associated with the state of dehydration (lose of water and minerals in the body) or malnutrition
Descrição

Cerebrovascular accident Complication | Neuroleptic Malignant Syndrome Complication | High fever Complication | Muscle Rigidity Complication | Tremor Complication | Confusion Complication | Increased sweating Complication | Tachycardia Complication | Hypertensive disease Complication | Myalgia Complication | Weakness Complication | Cerebrovascular accident | Neuroleptic Malignant Syndrome | High fever | Muscle Rigidity | Tremor | Confusion | Increased sweating | Tachycardia | Hypertensive disease | Myalgia | Weakness | Physical exhaustion Associated with Dehydration | Physical exhaustion Associated with Malnutrition

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0009566
UMLS CUI [2,1]
C0027849
UMLS CUI [2,2]
C0009566
UMLS CUI [3,1]
C0743973
UMLS CUI [3,2]
C0009566
UMLS CUI [4,1]
C0026837
UMLS CUI [4,2]
C0009566
UMLS CUI [5,1]
C0040822
UMLS CUI [5,2]
C0009566
UMLS CUI [6,1]
C0009676
UMLS CUI [6,2]
C0009566
UMLS CUI [7,1]
C0700590
UMLS CUI [7,2]
C0009566
UMLS CUI [8,1]
C0039231
UMLS CUI [8,2]
C0009566
UMLS CUI [9,1]
C0020538
UMLS CUI [9,2]
C0009566
UMLS CUI [10,1]
C0231528
UMLS CUI [10,2]
C0009566
UMLS CUI [11,1]
C3714552
UMLS CUI [11,2]
C0009566
UMLS CUI [12]
C0038454
UMLS CUI [13]
C0027849
UMLS CUI [14]
C0743973
UMLS CUI [15]
C0026837
UMLS CUI [16]
C0040822
UMLS CUI [17]
C0009676
UMLS CUI [18]
C0700590
UMLS CUI [19]
C0039231
UMLS CUI [20]
C0020538
UMLS CUI [21]
C0231528
UMLS CUI [22]
C3714552
UMLS CUI [23,1]
C0678687
UMLS CUI [23,2]
C0332281
UMLS CUI [23,3]
C0011175
UMLS CUI [24,1]
C0678687
UMLS CUI [24,2]
C0332281
UMLS CUI [24,3]
C0162429
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Similar models

Eligibility Schizophrenia NCT01606254

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
participants who have been diagnosed with schizophrenia in accordance with the diagnostic criteria of diagnostic and statistical manual of mental disorders 4th edition (dsm-iv)
boolean
C0036341 (UMLS CUI [1])
Inpatient | Outpatients
Item
participants may be inpatients or outpatients
boolean
C0021562 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
Antipsychotic Agents Oral
Item
participants who have been taking an oral antipsychotic medication for at least 28 days before the date of informed consent
boolean
C0040615 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
PANSS
Item
participants with a positive and negative syndrome scale (panss) score of less than or equal to 4 (moderate) at screening
boolean
C4086747 (UMLS CUI [1])
Risperidone
Item
participants who have taken risperidone by the start of investigational treatment and the record can be confirmed exclusion criteria
boolean
C0073393 (UMLS CUI [1])
Mental disorders | Exception Schizophrenia
Item
participants who have been diagnosed with a mental disease other than schizophrenia in accordance with the diagnostic criteria of diagnostic and statistical manual of mental disorders 4th edition (dsm-iv)
boolean
C0004936 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
Substance Use Disorders | Exception Nicotine Dependence | Exception Caffeine dependence
Item
participants who have been diagnosed with substance-related disorders (except nicotine and caffeine dependence)
boolean
C0038586 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0028043 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1386553 (UMLS CUI [3,2])
Parkinson Disease Complication
Item
participants with complicated parkinson's disease (a progressive disorder of the central nervous system, seen usually in older persons, in which there is muscle weakness, trembling and sweating)
boolean
C0030567 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
Convulsive disorder Complication | Epilepsy Complication
Item
participants with a complication of or with a history of convulsive disease such as epilepsy (seizure disorder)
boolean
C0234972 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C0014544 (UMLS CUI [2,1])
C0009566 (UMLS CUI [2,2])
Cerebrovascular accident Complication | Neuroleptic Malignant Syndrome Complication | High fever Complication | Muscle Rigidity Complication | Tremor Complication | Confusion Complication | Increased sweating Complication | Tachycardia Complication | Hypertensive disease Complication | Myalgia Complication | Weakness Complication | Cerebrovascular accident | Neuroleptic Malignant Syndrome | High fever | Muscle Rigidity | Tremor | Confusion | Increased sweating | Tachycardia | Hypertensive disease | Myalgia | Weakness | Physical exhaustion Associated with Dehydration | Physical exhaustion Associated with Malnutrition
Item
participants with a complication of or with a history of cerebro-vascular accident (stroke), neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness) or physical exhaustion associated with the state of dehydration (lose of water and minerals in the body) or malnutrition
boolean
C0038454 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C0027849 (UMLS CUI [2,1])
C0009566 (UMLS CUI [2,2])
C0743973 (UMLS CUI [3,1])
C0009566 (UMLS CUI [3,2])
C0026837 (UMLS CUI [4,1])
C0009566 (UMLS CUI [4,2])
C0040822 (UMLS CUI [5,1])
C0009566 (UMLS CUI [5,2])
C0009676 (UMLS CUI [6,1])
C0009566 (UMLS CUI [6,2])
C0700590 (UMLS CUI [7,1])
C0009566 (UMLS CUI [7,2])
C0039231 (UMLS CUI [8,1])
C0009566 (UMLS CUI [8,2])
C0020538 (UMLS CUI [9,1])
C0009566 (UMLS CUI [9,2])
C0231528 (UMLS CUI [10,1])
C0009566 (UMLS CUI [10,2])
C3714552 (UMLS CUI [11,1])
C0009566 (UMLS CUI [11,2])
C0038454 (UMLS CUI [12])
C0027849 (UMLS CUI [13])
C0743973 (UMLS CUI [14])
C0026837 (UMLS CUI [15])
C0040822 (UMLS CUI [16])
C0009676 (UMLS CUI [17])
C0700590 (UMLS CUI [18])
C0039231 (UMLS CUI [19])
C0020538 (UMLS CUI [20])
C0231528 (UMLS CUI [21])
C3714552 (UMLS CUI [22])
C0678687 (UMLS CUI [23,1])
C0332281 (UMLS CUI [23,2])
C0011175 (UMLS CUI [23,3])
C0678687 (UMLS CUI [24,1])
C0332281 (UMLS CUI [24,2])
C0162429 (UMLS CUI [24,3])
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