Informações:
Falhas:
ID
32040
Descrição
Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00615433
Link
https://clinicaltrials.gov/show/NCT00615433
Palavras-chave
Versões (1)
- 15/10/2018 15/10/2018 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
15 de outubro de 2018
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00615433
Eligibility Schizophrenia NCT00615433
- StudyEvent: Eligibility
Similar models
Eligibility Schizophrenia NCT00615433
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Informed Consent | Age
Item
provide written informed consent and aged between 18 and 75 years of age.
boolean
C0021430 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
Schizophrenia Primary
Item
meets dsm-iv criteria for a primary diagnosis of schizophrenia.
boolean
C0036341 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,2])
Pregnancy Absent | Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods
Item
not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Antipsychotic Agents Discontinue Willing
Item
able and agrees to remain off prior antipsychotic medication for the duration of study.
boolean
C0040615 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C1444662 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Physical health Medical History | Physical health Physical Examination | Physical health Laboratory Screening
Item
good physical health on the basis of medical history, physical examination, and laboratory screening.
boolean
C0517226 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0517226 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C0517226 (UMLS CUI [3,1])
C4542589 (UMLS CUI [3,2])
C0262926 (UMLS CUI [1,2])
C0517226 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C0517226 (UMLS CUI [3,1])
C4542589 (UMLS CUI [3,2])
Protocol Compliance
Item
willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.
boolean
C0525058 (UMLS CUI [1])
At risk for suicide | At risk for deliberate self harm | At risk of harming others | At risk for destructive behavior to property
Item
considered by the investigator to be at imminent risk of suicide or injury to self, others or property.
boolean
C0563664 (UMLS CUI [1])
C1276053 (UMLS CUI [2])
C1271966 (UMLS CUI [3])
C2584565 (UMLS CUI [4])
C1276053 (UMLS CUI [2])
C1271966 (UMLS CUI [3])
C2584565 (UMLS CUI [4])
Organic disease chronic Central Nervous System | Exception Schizophrenia
Item
any chronic organic disease of the cns (other than schizophrenia).
boolean
C0683324 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C3714787 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
C0205191 (UMLS CUI [1,2])
C3714787 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
Investigational New Drugs
Item
used investigational compound within 30 days.
boolean
C0013230 (UMLS CUI [1])
Substance Use Disorders | Alcoholic Intoxication, Chronic | Substance Dependence
Item
clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months
boolean
C0038586 (UMLS CUI [1])
C0001973 (UMLS CUI [2])
C0038580 (UMLS CUI [3])
C0001973 (UMLS CUI [2])
C0038580 (UMLS CUI [3])