Informatie:
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ID
23095
Beschrijving
A Comparison of the Pharmacokinetics and Safety of Long-acting Injectable Risperidone When Administered to Gluteal or Deltoid Intramuscular Injection Sites in Stable Schizophrenia Patients.; ODM derived from: https://clinicaltrials.gov/show/NCT00843687
Link
https://clinicaltrials.gov/show/NCT00843687
Trefwoorden
Versies (1)
- 23-06-17 23-06-17 -
Geüploaded op
23 juni 2017
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00843687
Eligibility Schizophrenia NCT00843687
- StudyEvent: Eligibility
Similar models
Eligibility Schizophrenia NCT00843687
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Chronic schizophrenia Subtype Any
Item
chronic schizophrenia of any subtype, according to diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria
boolean
C0221765 (UMLS CUI [1,1])
C0449560 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0449560 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Schizophrenia Stable | Pharmaceutical Preparations unchanged | Pharmaceutical Preparations Dosage unchanged
Item
stable schizophrenia without any changes in medications or dosage during the 4 weeks before the screening visit
boolean
C0036341 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0442739 (UMLS CUI [3,3])
C0205360 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0442739 (UMLS CUI [3,3])
Clinical Global Impression Questionnaire
Item
clinical global impression scale score of <=3 (mild)
boolean
C3639708 (UMLS CUI [1])
Informed Consent
Item
informed consent signed by the patient
boolean
C0021430 (UMLS CUI [1])
Healthy Volunteer | Physical Examination Pre-study | Medical History
Item
patient is otherwise healthy on the basis of a prestudy physical examination and medical history.
boolean
C1708335 (UMLS CUI [1])
C0031809 (UMLS CUI [2,1])
C1527048 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3])
C0031809 (UMLS CUI [2,1])
C1527048 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3])
Axis I diagnosis | Schizophrenia Excluded
Item
no dsm-iv axis i diagnosis other than schizophrenia
boolean
C0270287 (UMLS CUI [1])
C0036341 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0036341 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
no pregnant or breast feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Lacking
Item
no female subject of childbearing potential without adequate contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Drug Allergy Severe
Item
no history of severe drug allergy or hypersensitivity
boolean
C0013182 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,2])
Intramuscular injection | Gluteal Region Mass Inadequate | Deltoid region Mass Inadequate
Item
no patients with inadequate mass in the gluteal or deltoid regions to receive the intramuscular drug injections.
boolean
C0021492 (UMLS CUI [1])
C0282082 (UMLS CUI [2,1])
C0577573 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
C0230339 (UMLS CUI [3,1])
C0577573 (UMLS CUI [3,2])
C0205412 (UMLS CUI [3,3])
C0282082 (UMLS CUI [2,1])
C0577573 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
C0230339 (UMLS CUI [3,1])
C0577573 (UMLS CUI [3,2])
C0205412 (UMLS CUI [3,3])