ID

19363

Description

Weight Gain Management in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00486005

Lien

https://clinicaltrials.gov/show/NCT00486005

Mots-clés

Versions (1)
  1. 21/12/2016 21/12/2016 -
Téléchargé le

21 décembre 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00486005

Anglais

Eligibility Schizophrenia NCT00486005

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients, men or women, with age of 18 to 65 years
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
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
Description

Schizophrenia | Schizophrenia Acute phase Clinical

Type de données

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2,1]
C0036341
UMLS CUI [2,2]
C0439557
UMLS CUI [2,3]
C0205210
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.
Description

olanzapine U/day | Weight Gain Percentage

Type de données

boolean

Alias
UMLS CUI [1,1]
C0171023
UMLS CUI [1,2]
C0456683
UMLS CUI [2,1]
C0043094
UMLS CUI [2,2]
C0439165
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
Description

Patients Steady | Protocol Compliance | Informed Consent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0205361
UMLS CUI [2]
C0525058
UMLS CUI [3]
C0021430
women with potential to become pregnant must be using a medically acceptable and reliable means of birth control.
Description

Childbearing Potential Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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)
Description

Study Subject Participation Status | Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
people who have used clozapine within a period of 12 months before the beginning of the study
Description

Clozapine

Type de données

boolean

Alias
UMLS CUI [1]
C0009079
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
Description

Type 1 diabetes mellitus uncontrolled | Type II diabetes mellitus uncontrolled | Glycaemia control Medication commenced

Type de données

boolean

Alias
UMLS CUI [1]
C2732402
UMLS CUI [2]
C2733146
UMLS CUI [3,1]
C3267174
UMLS CUI [3,2]
C0451613
dsm-iv substance (except nicotine and caffeine) dependence within the past 30 days
Description

Substance Dependence | Nicotine Dependence | Caffeine dependence

Type de données

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0028043
UMLS CUI [3]
C1386553
current participation in programs of weight loss
Description

participation Weight Reduction Program

Type de données

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C3179079
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Similar models

Eligibility Schizophrenia NCT00486005

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
participation Weight Reduction Program
Item
current participation in programs of weight loss
boolean
C0679823 (UMLS CUI [1,1])
C3179079 (UMLS CUI [1,2])
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