ID

22275

Beschrijving

Influence of Nicotine on Cognitive Function in Schizophrenic Patients With and Without Comorbid Drug Dependence; ODM derived from: https://clinicaltrials.gov/show/NCT01037075

Link

https://clinicaltrials.gov/show/NCT01037075

Trefwoorden

Versies (1)
  1. 28-05-17 28-05-17 -
Geüploaded op

28 mei 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01037075

Engels

Eligibility Schizophrenia NCT01037075

1 Formulieren  
Criteria
Beschrijving

Criteria

all participants must meet the following criteria:
Beschrijving

inclusion criteria

Datatype

boolean

Alias
UMLS CUI [1]
C1512693
age 18 60
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
smoke 10 or more cigarettes/day for at least the past year
Beschrijving

tobacco use

Datatype

boolean

Alias
UMLS CUI [1]
C0543414
experimental groups 1 and 2, additional criteria:
Beschrijving

additional criteria

Datatype

boolean

Alias
UMLS CUI [1]
C1516637
dsm-iv diagnosis of schizophrenia or schizoaffective disorder (assessments pertaining to these diagnoses will be done in other mprc screening protocols).
Beschrijving

dsm-iv schizophrenia or schizoaffective disorder

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220952
UMLS CUI [1,2]
C0036341
UMLS CUI [1,3]
C0036337
experimental group 2, additional criteria:
Beschrijving

additional criteria

Datatype

boolean

Alias
UMLS CUI [1]
C1516637
dsm-iv diagnosis of abuse or dependence on cocaine and/or heroin or on methadone or buprenorphine maintenance.
Beschrijving

substance use disorder, cocaine, heroin, methadone, buprenorphine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0009170
UMLS CUI [1,3]
C0011892
UMLS CUI [1,4]
C0025605
UMLS CUI [1,5]
C0006405
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
comprehensive medical history:
Beschrijving

medical history

Datatype

boolean

Alias
UMLS CUI [1]
C0262926
exclusions: heart disease, uncontrolled blood pressure (persistent systolic above 155 or diastolic above 95), neurological conditions (stroke, seizure, history of head injury), asthma, emphysema, chronic bronchitis, chronic obstructive pulmonary disease, pathology of nasal passages that precludes the effective administration of nicotine nasal spray.
Beschrijving

heart disease, blood pressure, neurological disorder, asthma, emphysema, chronic bronchitis, copd, pathology of nasal passages

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0005823
UMLS CUI [3]
C0027765
UMLS CUI [4]
C0004096
UMLS CUI [5]
C0034067
UMLS CUI [6]
C0008677
UMLS CUI [7]
C0024117
UMLS CUI [8]
C0027424
drug use survey
Beschrijving

drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013227
all subjects:
Beschrijving

study subject

Datatype

boolean

Alias
UMLS CUI [1]
C0681850
exclude if treatment for tobacco dependence during the previous 6 months.
Beschrijving

tobacco dependence treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040332
UMLS CUI [1,2]
C0087111
healthy controls and schizophrenic patients without comorbid drug abuse or dependence: exclude if history alcohol or other substance dependence ever, or alcohol or other substance abuse in the past year. verify abstinence from controlled substances with urine screen (iscreen). participants in the above 2 groups who are positive for any illicit drug (with the exception of marijuana) will be excluded.
Beschrijving

substance use disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
structured clinical interview for dsm-iv
Beschrijving

structured clinical interview for dsm-iv

Datatype

boolean

Alias
UMLS CUI [1,1]
C0935589
UMLS CUI [1,2]
C0220952
healthy controls: exclude if any current psychiatric disorder
Beschrijving

healthy controls, psychiatric disorders

Datatype

boolean

Alias
UMLS CUI [1,1]
C2986479
UMLS CUI [1,2]
C0004936
urine pregnancy for females:
Beschrijving

pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
exclude if positive.
Beschrijving

pregnancy test

Datatype

boolean

Alias
UMLS CUI [1]
C0032976
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Similar models

Eligibility Schizophrenia NCT01037075

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
inclusion criteria
Item
all participants must meet the following criteria:
boolean
C1512693 (UMLS CUI [1])
age
Item
age 18 60
boolean
C0001779 (UMLS CUI [1])
tobacco use
Item
smoke 10 or more cigarettes/day for at least the past year
boolean
C0543414 (UMLS CUI [1])
additional criteria
Item
experimental groups 1 and 2, additional criteria:
boolean
C1516637 (UMLS CUI [1])
dsm-iv schizophrenia or schizoaffective disorder
Item
dsm-iv diagnosis of schizophrenia or schizoaffective disorder (assessments pertaining to these diagnoses will be done in other mprc screening protocols).
boolean
C0220952 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C0036337 (UMLS CUI [1,3])
additional criteria
Item
experimental group 2, additional criteria:
boolean
C1516637 (UMLS CUI [1])
substance use disorder, cocaine, heroin, methadone, buprenorphine
Item
dsm-iv diagnosis of abuse or dependence on cocaine and/or heroin or on methadone or buprenorphine maintenance.
boolean
C0038586 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
C0011892 (UMLS CUI [1,3])
C0025605 (UMLS CUI [1,4])
C0006405 (UMLS CUI [1,5])
Item Group
C0680251 (UMLS CUI)
medical history
Item
comprehensive medical history:
boolean
C0262926 (UMLS CUI [1])
heart disease, blood pressure, neurological disorder, asthma, emphysema, chronic bronchitis, copd, pathology of nasal passages
Item
exclusions: heart disease, uncontrolled blood pressure (persistent systolic above 155 or diastolic above 95), neurological conditions (stroke, seizure, history of head injury), asthma, emphysema, chronic bronchitis, chronic obstructive pulmonary disease, pathology of nasal passages that precludes the effective administration of nicotine nasal spray.
boolean
C0018799 (UMLS CUI [1])
C0005823 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
C0004096 (UMLS CUI [4])
C0034067 (UMLS CUI [5])
C0008677 (UMLS CUI [6])
C0024117 (UMLS CUI [7])
C0027424 (UMLS CUI [8])
drugs
Item
drug use survey
boolean
C0013227 (UMLS CUI [1])
study subject
Item
all subjects:
boolean
C0681850 (UMLS CUI [1])
tobacco dependence treatment
Item
exclude if treatment for tobacco dependence during the previous 6 months.
boolean
C0040332 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
substance use disorders
Item
healthy controls and schizophrenic patients without comorbid drug abuse or dependence: exclude if history alcohol or other substance dependence ever, or alcohol or other substance abuse in the past year. verify abstinence from controlled substances with urine screen (iscreen). participants in the above 2 groups who are positive for any illicit drug (with the exception of marijuana) will be excluded.
boolean
C0038586 (UMLS CUI [1])
structured clinical interview for dsm-iv
Item
structured clinical interview for dsm-iv
boolean
C0935589 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
healthy controls, psychiatric disorders
Item
healthy controls: exclude if any current psychiatric disorder
boolean
C2986479 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
pregnancy
Item
urine pregnancy for females:
boolean
C0032961 (UMLS CUI [1])
pregnancy test
Item
exclude if positive.
boolean
C0032976 (UMLS CUI [1])
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