ID

25309

Beschrijving

An Efficacy and Safety Study of One Dosage of Paliperidone Extended Release (ER) in Treating Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00524043

Link

https://clinicaltrials.gov/show/NCT00524043

Trefwoorden

Versies (1)
  1. 31-08-17 31-08-17 -
Geüploaded op

31 augustus 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00524043

Engels

Eligibility Schizophrenia NCT00524043

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with schizophrenia according to the diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) (295.10, 295.20, 295.30, 295.60, 295.90) at least 1 year before screening
Beschrijving

Schizophrenia disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0872146
experiencing an acute episode with a total panss score at screening of between 70 and 120
Beschrijving

Acute schizophrenic episode Positive and negative syndrome scale

Datatype

boolean

Alias
UMLS CUI [1,1]
C0813173
UMLS CUI [1,2]
C0451383
are otherwise physically healthy
Beschrijving

Healthy | Exception Schizophrenia

Datatype

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036341
agree to at least 8 days of voluntary hospitalization.
Beschrijving

Hospital stay duration Voluntary Agree

Datatype

boolean

Alias
UMLS CUI [1,1]
C4019086
UMLS CUI [1,2]
C0439656
UMLS CUI [1,3]
C3641827
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
active comorbid dsm-iv axis i diagnosis other than schizophrenia (nicotine and caffeine dependence are not exclusionary)
Beschrijving

Axis I diagnosis | Exception Schizophrenia | Exception Nicotine Dependence | Exception Caffeine dependence

Datatype

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036341
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0028043
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1386553
treatment with antidepressants (unless a subject has been on a stable dosage for at least 3 months before baseline) other than monoamine oxidase inhibitors
Beschrijving

Antidepressive Agents | Exception Antidepressive Agents Dose Stable | Exception Monoamine Oxidase Inhibitors

Datatype

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003289
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0205360
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0026457
dsm-iv diagnosis of substance dependence within 6 months before screening evaluation (nicotine and caffeine dependence are not exclusionary)
Beschrijving

Substance Dependence | Exception Nicotine Dependence | Exception Caffeine dependence

Datatype

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0028043
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1386553
any medical condition that could potentially alter the absorption, metabolism, or excretion of the study medication, such as crohn's disease, liver disease, or renal disease
Beschrijving

Medical condition Affecting Absorption Investigational New Drugs | Medical condition Affecting Metabolism Investigational New Drugs | Medical condition Affecting Excretion Investigational New Drugs | Crohn Disease | Liver diseases | Kidney Diseases

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C2698779
UMLS CUI [2,4]
C0013230
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C2699704
UMLS CUI [3,4]
C0013230
UMLS CUI [4]
C0010346
UMLS CUI [5]
C0023895
UMLS CUI [6]
C0022658
relevant history of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic disease.
Beschrijving

Cardiovascular Diseases | Respiration Disorders | Nervous system disorder | Seizures | Cerebrovascular Disorders | Kidney Diseases | Liver diseases | Endocrine System Diseases | Immune System Diseases | Cardiovascular Diseases Unstable | Respiration Disorders Unstable | Nervous system disorder Unstable | Seizures Unstable | Cerebrovascular Disorders Unstable | Kidney Diseases Unstable | Liver diseases Unstable | Endocrine System Diseases Unstable | Immune System Diseases Unstable

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0035204
UMLS CUI [3]
C0027765
UMLS CUI [4]
C0036572
UMLS CUI [5]
C0007820
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0023895
UMLS CUI [8]
C0014130
UMLS CUI [9]
C0021053
UMLS CUI [10,1]
C0007222
UMLS CUI [10,2]
C0443343
UMLS CUI [11,1]
C0035204
UMLS CUI [11,2]
C0443343
UMLS CUI [12,1]
C0027765
UMLS CUI [12,2]
C0443343
UMLS CUI [13,1]
C0036572
UMLS CUI [13,2]
C0443343
UMLS CUI [14,1]
C0007820
UMLS CUI [14,2]
C0443343
UMLS CUI [15,1]
C0022658
UMLS CUI [15,2]
C0443343
UMLS CUI [16,1]
C0023895
UMLS CUI [16,2]
C0443343
UMLS CUI [17,1]
C0014130
UMLS CUI [17,2]
C0443343
UMLS CUI [18,1]
C0021053
UMLS CUI [18,2]
C0443343
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Similar models

Eligibility Schizophrenia NCT00524043

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia disease length
Item
diagnosed with schizophrenia according to the diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) (295.10, 295.20, 295.30, 295.60, 295.90) at least 1 year before screening
boolean
C0036341 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Acute schizophrenic episode Positive and negative syndrome scale
Item
experiencing an acute episode with a total panss score at screening of between 70 and 120
boolean
C0813173 (UMLS CUI [1,1])
C0451383 (UMLS CUI [1,2])
Healthy | Exception Schizophrenia
Item
are otherwise physically healthy
boolean
C3898900 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
Hospital stay duration Voluntary Agree
Item
agree to at least 8 days of voluntary hospitalization.
boolean
C4019086 (UMLS CUI [1,1])
C0439656 (UMLS CUI [1,2])
C3641827 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis | Exception Schizophrenia | Exception Nicotine Dependence | Exception Caffeine dependence
Item
active comorbid dsm-iv axis i diagnosis other than schizophrenia (nicotine and caffeine dependence are not exclusionary)
boolean
C0270287 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0028043 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1386553 (UMLS CUI [4,2])
Antidepressive Agents | Exception Antidepressive Agents Dose Stable | Exception Monoamine Oxidase Inhibitors
Item
treatment with antidepressants (unless a subject has been on a stable dosage for at least 3 months before baseline) other than monoamine oxidase inhibitors
boolean
C0003289 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003289 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0026457 (UMLS CUI [3,2])
Substance Dependence | Exception Nicotine Dependence | Exception Caffeine dependence
Item
dsm-iv diagnosis of substance dependence within 6 months before screening evaluation (nicotine and caffeine dependence are not exclusionary)
boolean
C0038580 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0028043 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1386553 (UMLS CUI [3,2])
Medical condition Affecting Absorption Investigational New Drugs | Medical condition Affecting Metabolism Investigational New Drugs | Medical condition Affecting Excretion Investigational New Drugs | Crohn Disease | Liver diseases | Kidney Diseases
Item
any medical condition that could potentially alter the absorption, metabolism, or excretion of the study medication, such as crohn's disease, liver disease, or renal disease
boolean
C3843040 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C2698779 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C2699704 (UMLS CUI [3,3])
C0013230 (UMLS CUI [3,4])
C0010346 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
Cardiovascular Diseases | Respiration Disorders | Nervous system disorder | Seizures | Cerebrovascular Disorders | Kidney Diseases | Liver diseases | Endocrine System Diseases | Immune System Diseases | Cardiovascular Diseases Unstable | Respiration Disorders Unstable | Nervous system disorder Unstable | Seizures Unstable | Cerebrovascular Disorders Unstable | Kidney Diseases Unstable | Liver diseases Unstable | Endocrine System Diseases Unstable | Immune System Diseases Unstable
Item
relevant history of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic disease.
boolean
C0007222 (UMLS CUI [1])
C0035204 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
C0036572 (UMLS CUI [4])
C0007820 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0021053 (UMLS CUI [9])
C0007222 (UMLS CUI [10,1])
C0443343 (UMLS CUI [10,2])
C0035204 (UMLS CUI [11,1])
C0443343 (UMLS CUI [11,2])
C0027765 (UMLS CUI [12,1])
C0443343 (UMLS CUI [12,2])
C0036572 (UMLS CUI [13,1])
C0443343 (UMLS CUI [13,2])
C0007820 (UMLS CUI [14,1])
C0443343 (UMLS CUI [14,2])
C0022658 (UMLS CUI [15,1])
C0443343 (UMLS CUI [15,2])
C0023895 (UMLS CUI [16,1])
C0443343 (UMLS CUI [16,2])
C0014130 (UMLS CUI [17,1])
C0443343 (UMLS CUI [17,2])
C0021053 (UMLS CUI [18,1])
C0443343 (UMLS CUI [18,2])
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