ID

32265

Beschreibung

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

Stichworte

Versionen (1)
  1. 25.10.18 25.10.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

25. Oktober 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01606228

Englisch

Eligibility Schizophrenia NCT01606228

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients diagnosed with schizophrenia
Beschreibung

Schizophrenia

Datentyp

boolean

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

PANSS

Datentyp

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
Beschreibung

Antipsychotic Agents Absent | Schizophrenia

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Gender Pregnancy test negative | Gender Contraceptive methods

Datentyp

boolean

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

Exclusion Criteria

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

Medical condition Serious Unstable | Laboratory test result abnormal

Datentyp

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
Beschreibung

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

Datentyp

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)
Beschreibung

Lacking Able to swallow Investigational New Drugs

Datentyp

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
Beschreibung

Abnormal biochemistry finding

Datentyp

boolean

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

Substance Dependence

Datentyp

boolean

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

Urine drug screen positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0743300
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Ähnliche Modelle

Eligibility Schizophrenia NCT01606228

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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