ID

32265

Beschrijving

A Trial to Explore the Tolerability, Safety and Efficacy of Paliperidone Extended Release in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01606228

Link

https://clinicaltrials.gov/show/NCT01606228

Trefwoorden

Versies (1)
  1. 25-10-18 25-10-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

25 oktober 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01606228

Engels

Eligibility Schizophrenia NCT01606228

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients diagnosed with schizophrenia
Beschrijving

Schizophrenia

Datatype

boolean

Alias
UMLS CUI [1]
C0036341
patient with positive and negative syndrome scale (panss) score of 80 to 120 at screening
Beschrijving

PANSS

Datatype

boolean

Alias
UMLS CUI [1]
C4086747
patients who have not taken any antipsychotics in the past, and those were newly diagnosed with schizophrenia who have not taken any antipsychotics for at least one month prior to screening
Beschrijving

Antipsychotic Agents Absent | Schizophrenia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0036341
patient healthy on the basis of a physical examination, laboratory examination, and vital signs
Beschrijving

Patient Healthy Physical Examination | Patient Healthy Laboratory examination | Patient Healthy Vital signs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3898900
UMLS CUI [1,3]
C0031809
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C3898900
UMLS CUI [2,3]
C0260877
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C3898900
UMLS CUI [3,3]
C0518766
women must have a negative pregnancy test, and agree to practice an effective method of birth control before entry and throughout the study
Beschrijving

Gender Pregnancy test negative | Gender Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
serious unstable medical condition, including known clinically relevant laboratory abnormalities
Beschrijving

Medical condition Serious Unstable | Laboratory test result abnormal

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0443343
UMLS CUI [2]
C0438215
judged to be at high risk for adverse events, violence or self-harm
Beschrijving

High risk of Adverse event | High risk of Violence | High risk of Self-harm

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0877248
UMLS CUI [2,1]
C0332167
UMLS CUI [2,2]
C0042693
UMLS CUI [3,1]
C0332167
UMLS CUI [3,2]
C0424366
inability to swallow the study medication whole with the aid of water (patients may not chew, divide, dissolve, or crush the study medication)
Beschrijving

Lacking Able to swallow Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0013230
biochemistry results that are out of the laboratory's normal reference range and are deemed to be clinically significant by the investigator
Beschrijving

Abnormal biochemistry finding

Datatype

boolean

Alias
UMLS CUI [1]
C0586680
patients with a current use or known history (over the past 6 months) of substance dependence
Beschrijving

Substance Dependence

Datatype

boolean

Alias
UMLS CUI [1]
C0038580
positive urine drug examination
Beschrijving

Urine drug screen positive

Datatype

boolean

Alias
UMLS CUI [1]
C0743300
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Similar models

Eligibility Schizophrenia NCT01606228

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
patients diagnosed with schizophrenia
boolean
C0036341 (UMLS CUI [1])
PANSS
Item
patient with positive and negative syndrome scale (panss) score of 80 to 120 at screening
boolean
C4086747 (UMLS CUI [1])
Antipsychotic Agents Absent | Schizophrenia
Item
patients who have not taken any antipsychotics in the past, and those were newly diagnosed with schizophrenia who have not taken any antipsychotics for at least one month prior to screening
boolean
C0040615 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0036341 (UMLS CUI [2])
Patient Healthy Physical Examination | Patient Healthy Laboratory examination | Patient Healthy Vital signs
Item
patient healthy on the basis of a physical examination, laboratory examination, and vital signs
boolean
C0030705 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C3898900 (UMLS CUI [2,2])
C0260877 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C3898900 (UMLS CUI [3,2])
C0518766 (UMLS CUI [3,3])
Gender Pregnancy test negative | Gender Contraceptive methods
Item
women must have a negative pregnancy test, and agree to practice an effective method of birth control before entry and throughout the study
boolean
C0079399 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Medical condition Serious Unstable | Laboratory test result abnormal
Item
serious unstable medical condition, including known clinically relevant laboratory abnormalities
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2])
High risk of Adverse event | High risk of Violence | High risk of Self-harm
Item
judged to be at high risk for adverse events, violence or self-harm
boolean
C0332167 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0332167 (UMLS CUI [2,1])
C0042693 (UMLS CUI [2,2])
C0332167 (UMLS CUI [3,1])
C0424366 (UMLS CUI [3,2])
Lacking Able to swallow Investigational New Drugs
Item
inability to swallow the study medication whole with the aid of water (patients may not chew, divide, dissolve, or crush the study medication)
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Abnormal biochemistry finding
Item
biochemistry results that are out of the laboratory's normal reference range and are deemed to be clinically significant by the investigator
boolean
C0586680 (UMLS CUI [1])
Substance Dependence
Item
patients with a current use or known history (over the past 6 months) of substance dependence
boolean
C0038580 (UMLS CUI [1])
Urine drug screen positive
Item
positive urine drug examination
boolean
C0743300 (UMLS CUI [1])
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