Informações:
Falhas:
ID
37175
Descrição
An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT02320032
Link
https://clinicaltrials.gov/show/NCT02320032
Palavras-chave
Versões (1)
- 06/07/2019 06/07/2019 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
6 de julho de 2019
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Schizophrenia NCT02320032
Eligibility Schizophrenia NCT02320032
- StudyEvent: Eligibility
Similar models
Eligibility Schizophrenia NCT02320032
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Schizophrenia Stable | Schizoaffective Disorder
Item
has stable schizophrenia or schizoaffective disorder
boolean
C0036341 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0036337 (UMLS CUI [2])
C0205360 (UMLS CUI [1,2])
C0036337 (UMLS CUI [2])
Patient Tolerable Aripiprazole
Item
has demonstrated ability to tolerate aripiprazole
boolean
C0030705 (UMLS CUI [1,1])
C4053931 (UMLS CUI [1,2])
C0299792 (UMLS CUI [1,3])
C4053931 (UMLS CUI [1,2])
C0299792 (UMLS CUI [1,3])
Antipsychotic drug therapy Stable Unchanged
Item
has been on a stable antipsychotic medication regimen without any changes for at least 2 months prior to screening
boolean
C1319421 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Body mass index
Item
has a body mass index (bmi) of 18.0 to 35.0 kg/m2, inclusive
boolean
C1305855 (UMLS CUI [1])
Inclusion criteria Additional
Item
additional criteria may apply
boolean
C1512693 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
is pregnant, breastfeeding, or is planning to become pregnant during the study period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
aripiprazole lauroxil | Depot Aripiprazole Intramuscular | Antipsychotic Agents Injectable Long-term Active
Item
has received aripiprazole lauroxil or im depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months
boolean
C4056439 (UMLS CUI [1])
C0086129 (UMLS CUI [2,1])
C0299792 (UMLS CUI [2,2])
C1556154 (UMLS CUI [2,3])
C0040615 (UMLS CUI [3,1])
C0086466 (UMLS CUI [3,2])
C0443252 (UMLS CUI [3,3])
C0205177 (UMLS CUI [3,4])
C0086129 (UMLS CUI [2,1])
C0299792 (UMLS CUI [2,2])
C1556154 (UMLS CUI [2,3])
C0040615 (UMLS CUI [3,1])
C0086466 (UMLS CUI [3,2])
C0443252 (UMLS CUI [3,3])
C0205177 (UMLS CUI [3,4])
At risk for deliberate self harm
Item
is a danger to himself/herself at screening or upon admission
boolean
C1276053 (UMLS CUI [1])
HIV Infection | Hepatitis B | Hepatitis C | HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Item
has a history of or positive test result for human immunodeficiency virus (hiv), hepatitis b, or hepatitis c
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0019699 (UMLS CUI [4])
C0856706 (UMLS CUI [5])
C1112419 (UMLS CUI [6])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0019699 (UMLS CUI [4])
C0856706 (UMLS CUI [5])
C1112419 (UMLS CUI [6])
Urine drug screen positive
Item
has a positive urine drug screen at screening or day 1
boolean
C0743300 (UMLS CUI [1])
Exclusion Criteria Additional
Item
additional criteria may apply
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,2])