ID

32067

Beschreibung

Safety and Tolerability of Varenicline in Schizophrenia (SATOVA); ODM derived from: https://clinicaltrials.gov/show/NCT00702793

Link

https://clinicaltrials.gov/show/NCT00702793

Stichworte

  1. 16.10.18 16.10.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

16. Oktober 2018

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Schizophrenia NCT00702793

Eligibility Schizophrenia NCT00702793

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
inpatients with a diagnosis of schizophrenia or schizoaffective disorder
Beschreibung

Inpatient | Schizophrenia | Schizoaffective Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0021562
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0036337
individuals between the ages of 19 and 65 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
individuals that had smoked 10 cigarette/day or more during the previous year, and had no period of smoking abstinence longer than 3 months in the past year
Beschreibung

Tobacco use Number of cigarettes per day | Smoking abstinence Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
UMLS CUI [2,1]
C0814442
UMLS CUI [2,2]
C0449238
individuals that are not expected to be discharged from hospital within 4 months.
Beschreibung

Discharge from hospital Timepoint Expected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0586003
UMLS CUI [1,2]
C2348792
UMLS CUI [1,3]
C1517001
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically significant allergic reactions to the study medication
Beschreibung

Allergic Reaction Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0013230
clinically significant abnormalities in the screening laboratory values
Beschreibung

Laboratory test result abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0438215
subjects at significant risk of self-harm
Beschreibung

At risk for deliberate self harm

Datentyp

boolean

Alias
UMLS CUI [1]
C1276053
previous treatment with varenicline
Beschreibung

Varenicline

Datentyp

boolean

Alias
UMLS CUI [1]
C1569608
women who are pregnant, breast-feeding, or of child-bearing potential not using adequate contraception
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
men not using adequate contraception
Beschreibung

Gender Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
use of medications that might interfere with the study medication evaluation
Beschreibung

Pharmaceutical Preparations Interfere with Evaluation Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1261322
UMLS CUI [1,4]
C0013230
nicotine replacement
Beschreibung

Nicotine replacement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278444
nortriptyline
Beschreibung

Nortriptyline

Datentyp

boolean

Alias
UMLS CUI [1]
C0028420
clonidine
Beschreibung

Clonidine

Datentyp

boolean

Alias
UMLS CUI [1]
C0009014

Ähnliche Modelle

Eligibility Schizophrenia NCT00702793

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Inpatient | Schizophrenia | Schizoaffective Disorder
Item
inpatients with a diagnosis of schizophrenia or schizoaffective disorder
boolean
C0021562 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0036337 (UMLS CUI [3])
Age
Item
individuals between the ages of 19 and 65 years of age
boolean
C0001779 (UMLS CUI [1])
Tobacco use Number of cigarettes per day | Smoking abstinence Duration
Item
individuals that had smoked 10 cigarette/day or more during the previous year, and had no period of smoking abstinence longer than 3 months in the past year
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
C0814442 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Discharge from hospital Timepoint Expected
Item
individuals that are not expected to be discharged from hospital within 4 months.
boolean
C0586003 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Allergic Reaction Investigational New Drugs
Item
clinically significant allergic reactions to the study medication
boolean
C1527304 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Laboratory test result abnormal
Item
clinically significant abnormalities in the screening laboratory values
boolean
C0438215 (UMLS CUI [1])
At risk for deliberate self harm
Item
subjects at significant risk of self-harm
boolean
C1276053 (UMLS CUI [1])
Varenicline
Item
previous treatment with varenicline
boolean
C1569608 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
women who are pregnant, breast-feeding, or of child-bearing potential not using adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Gender Contraceptive methods Absent
Item
men not using adequate contraception
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Pharmaceutical Preparations Interfere with Evaluation Investigational New Drugs
Item
use of medications that might interfere with the study medication evaluation
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
Nicotine replacement
Item
nicotine replacement
boolean
C1278444 (UMLS CUI [1])
Nortriptyline
Item
nortriptyline
boolean
C0028420 (UMLS CUI [1])
Clonidine
Item
clonidine
boolean
C0009014 (UMLS CUI [1])

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