ID

32135

Beskrivning

Paliperidone Extended-Release (ER) Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00827840

Länk

https://clinicaltrials.gov/show/NCT00827840

Nyckelord

Versioner (1)
  1. 2018-10-20 2018-10-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 oktober 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00827840

Engelsk

Eligibility Schizophrenia NCT00827840

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients diagnosed as schizophrenia by dsm-iv-tr criteria both in inpatients
Beskrivning

Schizophrenia | Inpatient

Datatyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0021562
patients who are symptomatically stable, as judged by the treating psychiatrist, and receive a stable dose of risperidone for a minimum of 2 weeks before enrollment.
Beskrivning

Patient status Symptomatic Stable | Risperidone Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449437
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0073393
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
patients with ability to complete various questionnaires.
Beskrivning

Questionnaires Different Completion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C1705242
UMLS CUI [1,3]
C0205197
patients and/or their legal guardians/representatives who sufficiently understand the objective of the study and sign informed consent form
Beskrivning

Comprehension Study Protocol | Comprehension Study Protocol Patient Representatives | Informed Consent | Informed Consent Patient Representatives

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C0030701
UMLS CUI [3]
C0021430
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C0030701
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
active psychotic symptoms, including severe behavioral disturbance
Beskrivning

Psychotic symptoms | Behavior disturbance Severe

Datatyp

boolean

Alias
UMLS CUI [1]
C0871189
UMLS CUI [2,1]
C0149623
UMLS CUI [2,2]
C0205082
relevant history of or current presence of any significant or unstable medical disease
Beskrivning

Disease Significant | Disease Unstable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0443343
a woman who is pregnant, breast-feeding or planning to become pregnant during the study period
Beskrivning

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
patients with the history of serious allergy or multiple adverse drug reactions
Beskrivning

Hypersensitivity Serious | Adverse drug reactions Multiple

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0041755
UMLS CUI [2,2]
C0439064
patients with the history of taking paliperidone er within 60 days
Beskrivning

paliperidone

Datatyp

boolean

Alias
UMLS CUI [1]
C0753678
patients with history of taking clozapine within 60 days
Beskrivning

Clozapine

Datatyp

boolean

Alias
UMLS CUI [1]
C0009079
patients who require the treatment of other medications influencing cns, except permitted concomitant drugs in advance
Beskrivning

Requirement Pharmacotherapy Influence Central Nervous System

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0013216
UMLS CUI [1,3]
C4054723
UMLS CUI [1,4]
C3714787
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Similar models

Eligibility Schizophrenia NCT00827840

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia | Inpatient
Item
patients diagnosed as schizophrenia by dsm-iv-tr criteria both in inpatients
boolean
C0036341 (UMLS CUI [1])
C0021562 (UMLS CUI [2])
Patient status Symptomatic Stable | Risperidone Dose Stable
Item
patients who are symptomatically stable, as judged by the treating psychiatrist, and receive a stable dose of risperidone for a minimum of 2 weeks before enrollment.
boolean
C0449437 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0073393 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Questionnaires Different Completion
Item
patients with ability to complete various questionnaires.
boolean
C0034394 (UMLS CUI [1,1])
C1705242 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Comprehension Study Protocol | Comprehension Study Protocol Patient Representatives | Informed Consent | Informed Consent Patient Representatives
Item
patients and/or their legal guardians/representatives who sufficiently understand the objective of the study and sign informed consent form
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0030701 (UMLS CUI [2,3])
C0021430 (UMLS CUI [3])
C0021430 (UMLS CUI [4,1])
C0030701 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Psychotic symptoms | Behavior disturbance Severe
Item
active psychotic symptoms, including severe behavioral disturbance
boolean
C0871189 (UMLS CUI [1])
C0149623 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Disease Significant | Disease Unstable
Item
relevant history of or current presence of any significant or unstable medical disease
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
a woman who is pregnant, breast-feeding or planning to become pregnant during the study period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Hypersensitivity Serious | Adverse drug reactions Multiple
Item
patients with the history of serious allergy or multiple adverse drug reactions
boolean
C0020517 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0041755 (UMLS CUI [2,1])
C0439064 (UMLS CUI [2,2])
paliperidone
Item
patients with the history of taking paliperidone er within 60 days
boolean
C0753678 (UMLS CUI [1])
Clozapine
Item
patients with history of taking clozapine within 60 days
boolean
C0009079 (UMLS CUI [1])
Requirement Pharmacotherapy Influence Central Nervous System
Item
patients who require the treatment of other medications influencing cns, except permitted concomitant drugs in advance
boolean
C1514873 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C4054723 (UMLS CUI [1,3])
C3714787 (UMLS CUI [1,4])
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