Informações:
Falhas:
ID
19238
Descrição
Safety and Efficacy of Study Drug Versus Placebo for Negative Symptoms of Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00063297
Link
https://clinicaltrials.gov/show/NCT00063297
Palavras-chave
Versões (1)
- 14/12/2016 14/12/2016 -
Transferido a
14 de dezembro de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00063297
Eligibility Schizophrenia NCT00063297
- StudyEvent: Eligibility
Similar models
Eligibility Schizophrenia NCT00063297
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Adult | Age
Item
adults aged 18-60
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
Schizophrenia
Item
current diagnosis of schizophrenia
boolean
C0036341 (UMLS CUI [1])
Symptoms Negative Significant | Symptoms Positive Few | Hallucinations | Delusions | Major Depressive Disorder Evidence
Item
significant negative symptoms with few positive symptoms (e.g. hallucinations, delusions) and no evidence of major depression.
boolean
C1457887 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C1457887 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0205388 (UMLS CUI [2,3])
C0018524 (UMLS CUI [3])
C0011253 (UMLS CUI [4])
C1269683 (UMLS CUI [5,1])
C3887511 (UMLS CUI [5,2])
C1513916 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C1457887 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0205388 (UMLS CUI [2,3])
C0018524 (UMLS CUI [3])
C0011253 (UMLS CUI [4])
C1269683 (UMLS CUI [5,1])
C3887511 (UMLS CUI [5,2])
Childbearing Potential Pregnancy test negative
Item
female subjects of childbearing potential must test negative for pregnancy at the time of enrollment.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0427780 (UMLS CUI [1,2])
Informed Consent
Item
subjects must be able to provide consent
boolean
C0021430 (UMLS CUI [1])
Healthy | Medical Examination | Laboratory Procedures | Electrocardiography
Item
must be healthy based on medical exam, laboratory tests and electrocardiogram
boolean
C3898900 (UMLS CUI [1])
C0582103 (UMLS CUI [2])
C0022885 (UMLS CUI [3])
C1623258 (UMLS CUI [4])
C0582103 (UMLS CUI [2])
C0022885 (UMLS CUI [3])
C1623258 (UMLS CUI [4])
Exclusion Criteria
Item
exclusion:
boolean
C0680251 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
female subjects who are either pregnant or nursing.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Medical condition | Medical condition Unstable
Item
acute or unstable medical conditions
boolean
C3843040 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
CNS disorder
Item
diseases of the central nervous system
boolean
C0007682 (UMLS CUI [1])
At risk for suicide Serious | At risk for violence Serious
Item
subjects who are judged clinically to be at serious risk for suicide or violence
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0231418 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205404 (UMLS CUI [1,2])
C0231418 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Delusional disorder | Psychotic Disorders | Schizophreniform Disorders | Schizoaffective Disorder | Bipolar Disorder | Attention deficit hyperactivity disorder | Major Depressive Disorder | Substance Dependence
Item
subjects with delusional disorder, psychotic disorder nos, schizophreniform, schizoaffective disorder, bipolar disorder, attention deficit/hyperactivity disorder, major depressive disorder,alcohol or drug dependence
boolean
C0011251 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
C0036358 (UMLS CUI [3])
C0036337 (UMLS CUI [4])
C0005586 (UMLS CUI [5])
C1263846 (UMLS CUI [6])
C1269683 (UMLS CUI [7])
C0038580 (UMLS CUI [8])
C0033975 (UMLS CUI [2])
C0036358 (UMLS CUI [3])
C0036337 (UMLS CUI [4])
C0005586 (UMLS CUI [5])
C1263846 (UMLS CUI [6])
C1269683 (UMLS CUI [7])
C0038580 (UMLS CUI [8])