ID

32067

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00702793

Palabras clave

Versiones (1)
  1. 16/10/18 16/10/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

16 de octubre de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Schizophrenia NCT00702793

Inglés

Eligibility Schizophrenia NCT00702793

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Inpatient | Schizophrenia | Schizoaffective Disorder

Tipo de datos

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
Descripción

Age

Tipo de datos

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
Descripción

Tobacco use Number of cigarettes per day | Smoking abstinence Duration

Tipo de datos

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.
Descripción

Discharge from hospital Timepoint Expected

Tipo de datos

boolean

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

Exclusion Criteria

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

Allergic Reaction Investigational New Drugs

Tipo de datos

boolean

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

Laboratory test result abnormal

Tipo de datos

boolean

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

At risk for deliberate self harm

Tipo de datos

boolean

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

Varenicline

Tipo de datos

boolean

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

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Tipo de datos

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
Descripción

Gender Contraceptive methods Absent

Tipo de datos

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
Descripción

Pharmaceutical Preparations Interfere with Evaluation Investigational New Drugs

Tipo de datos

boolean

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

Nicotine replacement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278444
nortriptyline
Descripción

Nortriptyline

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0028420
clonidine
Descripción

Clonidine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009014
Volver a la parte superior de la página

Similar models

Eligibility Schizophrenia NCT00702793

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial