Informationen:
Fehler:
ID
32023
Beschreibung
Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00549718
Link
https://clinicaltrials.gov/show/NCT00549718
Stichworte
Versionen (1)
- 13.10.18 13.10.18 -
Rechteinhaber
See clinicaltrials.gov
Hochgeladen am
13. Oktober 2018
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00549718
Eligibility Schizophrenia NCT00549718
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Schizophrenia NCT00549718
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Inclusion criteria Fulfill
Item
to be eligible to enter the study, each patient must comply with the following inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,2])
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 | Reproductive potential Sexual Abstinence | Reproductive 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])
C4034483 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [1,2])
C4034483 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Antipsychotic Agents To be stopped
Item
able and agrees to remain off prior antipsychotic medication for the duration of study.
boolean
C0040615 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C1272691 (UMLS CUI [1,2])
Physical Well-being Medical History | Physical Well-being Physical Examination | Physical Well-being 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 | Risk of violence or harm to 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])
C0549013 (UMLS CUI [3])
C2584565 (UMLS CUI [4])
C1276053 (UMLS CUI [2])
C0549013 (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])
Compound Investigational
Item
used investigational compound within 30 days.
boolean
C1706082 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C1517586 (UMLS CUI [1,2])
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])