ID

23050

Descrição

Olanzapine Pamoate Depot Versus Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00320489

Link

https://clinicaltrials.gov/show/NCT00320489

Palavras-chave

Versões (2)
  1. 20/06/2017 20/06/2017 -
  2. 21/06/2017 21/06/2017 -
Transferido a

21 de junho de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00320489

Inglês

Eligibility Schizophrenia NCT00320489

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of schizophrenia
Descrição

Schizophrenia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0036341
must be an outpatient (not requiring hospitalization) now and for at least the past 8 weeks.
Descrição

Outpatient

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0029921
disease symptoms must meet a certain range as assessed by the clinician.
Descrição

Signs and Symptoms

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0037088
patient has experienced at least two episodes of clinical worsening of their condition. this could mean admission to a hospital or an emergency room visit. this could mean that a new medication was added, medication dose was increased, or medication was switched in order to better control symptoms of the condition.
Descrição

Condition Worsening Episode Quantity | Hospital admission | Emergency department patient visit | New medication added | Medication dose increased | Change of medication

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332271
UMLS CUI [1,3]
C0332189
UMLS CUI [1,4]
C1265611
UMLS CUI [2]
C0184666
UMLS CUI [3]
C0586082
UMLS CUI [4]
C0555964
UMLS CUI [5]
C1611744
UMLS CUI [6]
C0580105
the patient must have an unsatisfactory response to their current medication or be experiencing negative effects of their current medication or not always take their current medication so that a change in current medication is desired.
Descrição

Pharmaceutical Preparations Response Unsatisfactory | Adverse reaction to drug | Pharmaceutical Preparations Intake Irregular | Change of medication Favorable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1704632
UMLS CUI [1,3]
C0439856
UMLS CUI [2]
C0041755
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1512806
UMLS CUI [3,3]
C0205271
UMLS CUI [4,1]
C0580105
UMLS CUI [4,2]
C3640814
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are actively suicidal.
Descrição

Suicidal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0438696
patients who are pregnant or nursing.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients who have stopped past treatment with olanzapine because of adverse events, are treatment resistant or allergic to olanzapine, or have a condition which would prevent use of a long acting form of olanzapine.
Descrição

Olanzapine stopped Due to Adverse event | Olanzapine Treatment Resistant | Hypersensitivity Olanzapine | Condition Preventing Olanzapine Active Long-term

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0171023
UMLS CUI [1,2]
C1272691
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0877248
UMLS CUI [2,1]
C0171023
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0332325
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0171023
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C0171023
UMLS CUI [4,4]
C0205177
UMLS CUI [4,5]
C0443252
patients with uncorrected narrow-angle glaucoma, seizures, uncontrolled diabetes, certain diseases of the liver, uncontrolled thyroid condition or other serious or unstable illness.
Descrição

Angle Closure Glaucoma uncorrected | Seizures | Diabetic - poor control | Liver diseases | Thyroid Disease Uncontrolled | Illness Serious | Illness Unstable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0017605
UMLS CUI [1,2]
C4072785
UMLS CUI [2]
C0036572
UMLS CUI [3]
C0421258
UMLS CUI [4]
C0023895
UMLS CUI [5,1]
C0040128
UMLS CUI [5,2]
C0205318
UMLS CUI [6,1]
C0221423
UMLS CUI [6,2]
C0205404
UMLS CUI [7,1]
C0221423
UMLS CUI [7,2]
C0443343
patients with parkinson's disease, psychosis related to dementia or other related disorders.
Descrição

Parkinson Disease | Psychotic Disorder Relationship Dementia | Disease Related

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2,1]
C0033975
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0497327
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0439849
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Similar models

Eligibility Schizophrenia NCT00320489

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
clinical diagnosis of schizophrenia
boolean
C0036341 (UMLS CUI [1])
Outpatient
Item
must be an outpatient (not requiring hospitalization) now and for at least the past 8 weeks.
boolean
C0029921 (UMLS CUI [1])
Signs and Symptoms
Item
disease symptoms must meet a certain range as assessed by the clinician.
boolean
C0037088 (UMLS CUI [1])
Condition Worsening Episode Quantity | Hospital admission | Emergency department patient visit | New medication added | Medication dose increased | Change of medication
Item
patient has experienced at least two episodes of clinical worsening of their condition. this could mean admission to a hospital or an emergency room visit. this could mean that a new medication was added, medication dose was increased, or medication was switched in order to better control symptoms of the condition.
boolean
C0348080 (UMLS CUI [1,1])
C0332271 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0184666 (UMLS CUI [2])
C0586082 (UMLS CUI [3])
C0555964 (UMLS CUI [4])
C1611744 (UMLS CUI [5])
C0580105 (UMLS CUI [6])
Pharmaceutical Preparations Response Unsatisfactory | Adverse reaction to drug | Pharmaceutical Preparations Intake Irregular | Change of medication Favorable
Item
the patient must have an unsatisfactory response to their current medication or be experiencing negative effects of their current medication or not always take their current medication so that a change in current medication is desired.
boolean
C0013227 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
C0439856 (UMLS CUI [1,3])
C0041755 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C1512806 (UMLS CUI [3,2])
C0205271 (UMLS CUI [3,3])
C0580105 (UMLS CUI [4,1])
C3640814 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Suicidal
Item
patients who are actively suicidal.
boolean
C0438696 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
patients who are pregnant or nursing.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Olanzapine stopped Due to Adverse event | Olanzapine Treatment Resistant | Hypersensitivity Olanzapine | Condition Preventing Olanzapine Active Long-term
Item
patients who have stopped past treatment with olanzapine because of adverse events, are treatment resistant or allergic to olanzapine, or have a condition which would prevent use of a long acting form of olanzapine.
boolean
C0171023 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,4])
C0171023 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0332325 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0171023 (UMLS CUI [3,2])
C0348080 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0171023 (UMLS CUI [4,3])
C0205177 (UMLS CUI [4,4])
C0443252 (UMLS CUI [4,5])
Angle Closure Glaucoma uncorrected | Seizures | Diabetic - poor control | Liver diseases | Thyroid Disease Uncontrolled | Illness Serious | Illness Unstable
Item
patients with uncorrected narrow-angle glaucoma, seizures, uncontrolled diabetes, certain diseases of the liver, uncontrolled thyroid condition or other serious or unstable illness.
boolean
C0017605 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
C0036572 (UMLS CUI [2])
C0421258 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0040128 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0221423 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C0221423 (UMLS CUI [7,1])
C0443343 (UMLS CUI [7,2])
Parkinson Disease | Psychotic Disorder Relationship Dementia | Disease Related
Item
patients with parkinson's disease, psychosis related to dementia or other related disorders.
boolean
C0030567 (UMLS CUI [1])
C0033975 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0497327 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
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