ID

37165

Descripción

Evaluation Study of New Compounds With Potential Use in Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00916201

Link

https://clinicaltrials.gov/show/NCT00916201

Palabras clave

Versiones (1)
  1. 5/7/19 5/7/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

5 de julio de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00916201

Inglés

Eligibility Schizophrenia NCT00916201

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy volunteers
Descripción

Healthy Volunteers

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1708335
informed consent given by the subject
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
both, female and male subjects may participate
Descripción

Gender

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
age between 18 and 65 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
negative drug-screening at the time of screening
Descripción

Drug screen Negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C1513916
in female participants in fertile age, reliable contraception, which means contraception's pearl-index is equal or smaller than 1.
Descripción

Childbearing Potential Contraceptive methods | Other Coding

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C3846158
non-smoker
Descripción

Non-smoker

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0337672
body mass index between 18 and 40.
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
lack of accountability
Descripción

Accountability Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0078889
UMLS CUI [1,2]
C0332268
any current psychiatric disorder through the structured clinical interview for dsm-iv (scid) at the time of screening
Descripción

Mental disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004936
any known psychiatric or neurological illness in the participant's history.
Descripción

Mental disorders Medical History | Nervous system disorder Medical History

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0262926
known family history concerning psychiatric disorders
Descripción

Family history of psychiatric disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0260517
relevant use of cannabis (which is defined on the present state of knowledge as at the most five times lifetime-consumption and no consumption for at least one year)
Descripción

Cannabis Consumption Lifetime

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0678449
UMLS CUI [1,2]
C0678263
UMLS CUI [1,3]
C4071830
pregnancy or lactation phase in female at the time of screening
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
severe physical (internal) or neurological illness, especially cardiovascular, renal, advanced respiratory, haematological or endocrinological failures or infectious diseases (acute hepatitis a, b or c or hiv) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, at the discretion of the investigator
Descripción

Disease Physical Internal Severe | Nervous system disorder Severe | Cardiovascular Diseases | Kidney Failure | Respiratory Failure Advanced | Hematological Disease | Endocrine System Diseases | Communicable Diseases | Hepatitis A | Hepatitis B | Hepatitis C | HIV Infection | Medical History | Clinical examination | Laboratory Procedures

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205485
UMLS CUI [1,3]
C0205102
UMLS CUI [1,4]
C0205082
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0035078
UMLS CUI [5,1]
C1145670
UMLS CUI [5,2]
C0205179
UMLS CUI [6]
C0018939
UMLS CUI [7]
C0014130
UMLS CUI [8]
C0009450
UMLS CUI [9]
C0019159
UMLS CUI [10]
C0019163
UMLS CUI [11]
C0019196
UMLS CUI [12]
C0019693
UMLS CUI [13]
C0262926
UMLS CUI [14]
C1456356
UMLS CUI [15]
C0022885
consumption of any illegal drugs (except cannabis in history, see above)
Descripción

Illicit medication use | Exception Cannabis Medical History

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0281875
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678449
UMLS CUI [2,3]
C0262926
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Similar models

Eligibility Schizophrenia NCT00916201

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers
Item
healthy volunteers
boolean
C1708335 (UMLS CUI [1])
Informed Consent
Item
informed consent given by the subject
boolean
C0021430 (UMLS CUI [1])
Gender
Item
both, female and male subjects may participate
boolean
C0079399 (UMLS CUI [1])
Age
Item
age between 18 and 65 years
boolean
C0001779 (UMLS CUI [1])
Drug screen Negative
Item
negative drug-screening at the time of screening
boolean
C0373483 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods | Other Coding
Item
in female participants in fertile age, reliable contraception, which means contraception's pearl-index is equal or smaller than 1.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
Non-smoker
Item
non-smoker
boolean
C0337672 (UMLS CUI [1])
Body mass index
Item
body mass index between 18 and 40.
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Accountability Lacking
Item
lack of accountability
boolean
C0078889 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Mental disorders
Item
any current psychiatric disorder through the structured clinical interview for dsm-iv (scid) at the time of screening
boolean
C0004936 (UMLS CUI [1])
Mental disorders Medical History | Nervous system disorder Medical History
Item
any known psychiatric or neurological illness in the participant's history.
boolean
C0004936 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0027765 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
Family history of psychiatric disorder
Item
known family history concerning psychiatric disorders
boolean
C0260517 (UMLS CUI [1])
Cannabis Consumption Lifetime
Item
relevant use of cannabis (which is defined on the present state of knowledge as at the most five times lifetime-consumption and no consumption for at least one year)
boolean
C0678449 (UMLS CUI [1,1])
C0678263 (UMLS CUI [1,2])
C4071830 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnancy or lactation phase in female at the time of screening
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Disease Physical Internal Severe | Nervous system disorder Severe | Cardiovascular Diseases | Kidney Failure | Respiratory Failure Advanced | Hematological Disease | Endocrine System Diseases | Communicable Diseases | Hepatitis A | Hepatitis B | Hepatitis C | HIV Infection | Medical History | Clinical examination | Laboratory Procedures
Item
severe physical (internal) or neurological illness, especially cardiovascular, renal, advanced respiratory, haematological or endocrinological failures or infectious diseases (acute hepatitis a, b or c or hiv) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, at the discretion of the investigator
boolean
C0012634 (UMLS CUI [1,1])
C0205485 (UMLS CUI [1,2])
C0205102 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
C0027765 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0007222 (UMLS CUI [3])
C0035078 (UMLS CUI [4])
C1145670 (UMLS CUI [5,1])
C0205179 (UMLS CUI [5,2])
C0018939 (UMLS CUI [6])
C0014130 (UMLS CUI [7])
C0009450 (UMLS CUI [8])
C0019159 (UMLS CUI [9])
C0019163 (UMLS CUI [10])
C0019196 (UMLS CUI [11])
C0019693 (UMLS CUI [12])
C0262926 (UMLS CUI [13])
C1456356 (UMLS CUI [14])
C0022885 (UMLS CUI [15])
Illicit medication use | Exception Cannabis Medical History
Item
consumption of any illegal drugs (except cannabis in history, see above)
boolean
C0281875 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678449 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2,3])
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