ID

21786

Beschrijving

Injection Site Tolerability of Multiple Dose Treatment With Long-acting Injectable Risperidone Administered Via Deltoid Muscle in Chronic Schizophrenia Patients.; ODM derived from: https://clinicaltrials.gov/show/NCT00828958

Link

https://clinicaltrials.gov/show/NCT00828958

Trefwoorden

  1. 30-04-17 30-04-17 -
Geüploaded op

30 april 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Schizophrenia NCT00828958

Eligibility Schizophrenia NCT00828958

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic schizophrenia of any subtype, according to dsm-iv criteria
Beschrijving

Chronic Schizophrenia

Datatype

boolean

Alias
UMLS CUI [1]
C0221765
under current treatment with long-acting injectable risperidone 25 mg or 37.5 mg gluteal injections in an adequate study for at least 2 injections, and in need of a dose increase of long-acting injectable risperidone for clinical reason
Beschrijving

Risperidone

Datatype

boolean

Alias
UMLS CUI [1]
C0073393
informed consent signed by the patient
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
patient is otherwise healthy on the basis of a prestudy physical examination and medical history.
Beschrijving

Health Status

Datatype

boolean

Alias
UMLS CUI [1]
C0018759
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
no dsm iv axis i diagnosis other than schizophrenia
Beschrijving

Axis I Diagnosis

Datatype

boolean

Alias
UMLS CUI [1]
C0270287
no pregnant or breast feeding women
Beschrijving

Gynaecological Status

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
no female subject of childbearing potential without adequate contraception
Beschrijving

Contraceptive Methods

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
no history of severe drug allergy or hypersensitivity
Beschrijving

Drug Allergy or Hypersensitivity

Datatype

boolean

Alias
UMLS CUI [1]
C0013182
UMLS CUI [2]
C0020517
no patients with inadequate mass in the deltoid regions to receive the intramuscular drug injections.
Beschrijving

Mass in deltoid region

Datatype

boolean

Alias
UMLS CUI [1,1]
C3273930
UMLS CUI [1,2]
C0224234

Similar models

Eligibility Schizophrenia NCT00828958

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Schizophrenia
Item
chronic schizophrenia of any subtype, according to dsm-iv criteria
boolean
C0221765 (UMLS CUI [1])
Risperidone
Item
under current treatment with long-acting injectable risperidone 25 mg or 37.5 mg gluteal injections in an adequate study for at least 2 injections, and in need of a dose increase of long-acting injectable risperidone for clinical reason
boolean
C0073393 (UMLS CUI [1])
Informed Consent
Item
informed consent signed by the patient
boolean
C0021430 (UMLS CUI [1])
Health Status
Item
patient is otherwise healthy on the basis of a prestudy physical examination and medical history.
boolean
C0018759 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Axis I Diagnosis
Item
no dsm iv axis i diagnosis other than schizophrenia
boolean
C0270287 (UMLS CUI [1])
Gynaecological Status
Item
no pregnant or breast feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraceptive Methods
Item
no female subject of childbearing potential without adequate contraception
boolean
C0700589 (UMLS CUI [1])
Drug Allergy or Hypersensitivity
Item
no history of severe drug allergy or hypersensitivity
boolean
C0013182 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
Mass in deltoid region
Item
no patients with inadequate mass in the deltoid regions to receive the intramuscular drug injections.
boolean
C3273930 (UMLS CUI [1,1])
C0224234 (UMLS CUI [1,2])

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