Informações:
Falhas:
ID
19363
Descrição
Weight Gain Management in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00486005
Link
https://clinicaltrials.gov/show/NCT00486005
Palavras-chave
Versões (1)
- 21/12/2016 21/12/2016 -
Transferido a
21 de dezembro de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00486005
Eligibility Schizophrenia NCT00486005
- StudyEvent: Eligibility
Similar models
Eligibility Schizophrenia NCT00486005
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age
Item
patients, men or women, with age of 18 to 65 years
boolean
C0001779 (UMLS CUI [1])
Schizophrenia | Schizophrenia Acute phase Clinical
Item
patients must have schizophrenia that meets disease diagnostic criteria as defined in dsm-iv sections 295.10, 295.20, 295.30, or 295.90 and not to be in a clinically acute phase, in accordance with the judgment of the investigator
boolean
C0036341 (UMLS CUI [1])
C0036341 (UMLS CUI [2,1])
C0439557 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])
C0036341 (UMLS CUI [2,1])
C0439557 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])
olanzapine U/day | Weight Gain Percentage
Item
patients in use of 5 mg/day and 20 mg/day of olanzapine for a period not less than 2 months and not greater than 6 months and that have increased at least 5% of their corporal weight since the beginning of the treatment with olanzapine.
boolean
C0171023 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0043094 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0456683 (UMLS CUI [1,2])
C0043094 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Patients Steady | Protocol Compliance | Informed Consent
Item
the individuals must be trustworthy, and have a level of understanding enough to carry out all the tests and examinations demanded for the protocol, to understand the nature of the study and to have signed the informed consent
boolean
C0030705 (UMLS CUI [1,1])
C0205361 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
C0205361 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
Childbearing Potential Contraceptive methods
Item
women with potential to become pregnant must be using a medically acceptable and reliable means of birth control.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs
Item
participation in a clinical study of another drug in investigation within a period of 1 month (30 days) before the entrance in the study (visit 1)
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0013230 (UMLS CUI [2])
Clozapine
Item
people who have used clozapine within a period of 12 months before the beginning of the study
boolean
C0009079 (UMLS CUI [1])
Type 1 diabetes mellitus uncontrolled | Type II diabetes mellitus uncontrolled | Glycaemia control Medication commenced
Item
people with diagnosis of diabetes mellitus types i or ii without adjusted clinical control or have initiated the medication use for glycemic control in the last 6 months
boolean
C2732402 (UMLS CUI [1])
C2733146 (UMLS CUI [2])
C3267174 (UMLS CUI [3,1])
C0451613 (UMLS CUI [3,2])
C2733146 (UMLS CUI [2])
C3267174 (UMLS CUI [3,1])
C0451613 (UMLS CUI [3,2])
Substance Dependence | Nicotine Dependence | Caffeine dependence
Item
dsm-iv substance (except nicotine and caffeine) dependence within the past 30 days
boolean
C0038580 (UMLS CUI [1])
C0028043 (UMLS CUI [2])
C1386553 (UMLS CUI [3])
C0028043 (UMLS CUI [2])
C1386553 (UMLS CUI [3])
participation Weight Reduction Program
Item
current participation in programs of weight loss
boolean
C0679823 (UMLS CUI [1,1])
C3179079 (UMLS CUI [1,2])
C3179079 (UMLS CUI [1,2])