ID

19240

Description

Intramuscular Injections of Paliperidone Palmitate in the Arm or Buttock of Subjects With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00073320

Link

https://clinicaltrials.gov/show/NCT00073320

Keywords

Versions (1)
  1. 12/14/16 12/14/16 -
Uploaded on

December 14, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00073320

English

Eligibility Schizophrenia NCT00073320

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with a diagnosis of schizophrenia
Description

Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0036341
clinically stable with no change in current antipsychotic medications
Description

Antipsychotic Agents Stable Clinical Unchanged

Data type

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0205210
UMLS CUI [1,4]
C0442739
meet panss score criteria
Description

Positive and negative syndrome scale Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0451383
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
have a body mass index (bmi) between 15 and 35 kilogram (kg)/meter (m)2.
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with dsm-iv diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence
Description

Substance Dependence | Nicotine Dependence | Caffeine dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0028043
UMLS CUI [3]
C1386553
involuntarily-committed
Description

Involuntary Commitment

Data type

boolean

Alias
UMLS CUI [1]
C0021954
have moderately severe or severe eps symptoms
Description

Extrapyramidal symptoms Moderate | Extrapyramidal symptoms Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0234133
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0234133
UMLS CUI [2,2]
C0205082
history of malignant neuroleptic syndrome
Description

Neuroleptic Malignant Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0027849
have current suicidal ideation or demonstrates violence
Description

Feeling suicidal | patient violence

Data type

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2]
C0871991
current presence of any significant or unstable medication condition
Description

Condition Pharmaceutical Preparations Significant | Condition Pharmaceutical Preparations Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0750502
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0443343
treatment with any protocol disallowed therapies
Description

Therapeutic procedure Illicit Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332266
UMLS CUI [1,3]
C2348563
clinically significant result from screening laboratory or ecg.
Description

Result Clinical Significance Screening | Result Clinical Significance Laboratory Procedures | Result Clinical Significance Electrocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0220908
UMLS CUI [2,1]
C0456984
UMLS CUI [2,2]
C2826293
UMLS CUI [2,3]
C0022885
UMLS CUI [3,1]
C0456984
UMLS CUI [3,2]
C2826293
UMLS CUI [3,3]
C1623258
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Similar models

Eligibility Schizophrenia NCT00073320

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
patients with a diagnosis of schizophrenia
boolean
C0036341 (UMLS CUI [1])
Antipsychotic Agents Stable Clinical Unchanged
Item
clinically stable with no change in current antipsychotic medications
boolean
C0040615 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0442739 (UMLS CUI [1,4])
Positive and negative syndrome scale Criteria Fulfill
Item
meet panss score criteria
boolean
C0451383 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Body mass index
Item
have a body mass index (bmi) between 15 and 35 kilogram (kg)/meter (m)2.
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Substance Dependence | Nicotine Dependence | Caffeine dependence
Item
patients with dsm-iv diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence
boolean
C0038580 (UMLS CUI [1])
C0028043 (UMLS CUI [2])
C1386553 (UMLS CUI [3])
Involuntary Commitment
Item
involuntarily-committed
boolean
C0021954 (UMLS CUI [1])
Extrapyramidal symptoms Moderate | Extrapyramidal symptoms Severe
Item
have moderately severe or severe eps symptoms
boolean
C0234133 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0234133 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Neuroleptic Malignant Syndrome
Item
history of malignant neuroleptic syndrome
boolean
C0027849 (UMLS CUI [1])
Feeling suicidal | patient violence
Item
have current suicidal ideation or demonstrates violence
boolean
C0424000 (UMLS CUI [1])
C0871991 (UMLS CUI [2])
Condition Pharmaceutical Preparations Significant | Condition Pharmaceutical Preparations Unstable
Item
current presence of any significant or unstable medication condition
boolean
C0348080 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0443343 (UMLS CUI [2,3])
Therapeutic procedure Illicit Study Protocol
Item
treatment with any protocol disallowed therapies
boolean
C0087111 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Result Clinical Significance Screening | Result Clinical Significance Laboratory Procedures | Result Clinical Significance Electrocardiography
Item
clinically significant result from screening laboratory or ecg.
boolean
C0456984 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
C0456984 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0022885 (UMLS CUI [2,3])
C0456984 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C1623258 (UMLS CUI [3,3])
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