ID

32157

Description

Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00862992

Link

https://clinicaltrials.gov/show/NCT00862992

Keywords

Versions (1)
  1. 10/22/18 10/22/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 22, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00862992

English

Eligibility Schizophrenia NCT00862992

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients meeting dsm-iv-tr criteria for schizophrenia
Description

Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0036341
panss total score <= 120 during the observation period
Description

PANSS

Data type

boolean

Alias
UMLS CUI [1]
C4086747
patients who have been treated with oral antipsychotics within 4 weeks before informed consent
Description

Antipsychotic Agents Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C1527415
patients whose consent is obtained from themselves in written form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have defined as any mental disorder other than "schizophrenia" based on the criteria of dsm-iv-tr
Description

Mental disorders | Exception Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036341
history of drug or alcohol abuse
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
concurrent parkinson's disease
Description

Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C0030567
history of, or concurrent spastic disorders like epilepsy, cerebrovascular disease, anuresis or adynamic(= paralytic) ileus, malignant syndrome, diabetes, hepatic disorder
Description

Disease Spastic | Epilepsy | Cerebrovascular Disorders | Anuria | Paralytic Ileus | Malignant syndrome | Diabetes Mellitus | Liver disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0443306
UMLS CUI [2]
C0014544
UMLS CUI [3]
C0007820
UMLS CUI [4]
C0003460
UMLS CUI [5]
C0030446
UMLS CUI [6]
C0948281
UMLS CUI [7]
C0011849
UMLS CUI [8]
C0023895
patients who exhibit abnormalities on physical examination, have abnormal vital signs, ecg, or clinical laboratory values
Description

Physical examination abnormal | Abnormal vital signs | ECG abnormal | Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0747585
UMLS CUI [2]
C0277804
UMLS CUI [3]
C0522055
UMLS CUI [4]
C0438215
current cataract during the observation period
Description

Cataract

Data type

boolean

Alias
UMLS CUI [1]
C0086543
history of shock or anaphylactoid symptoms to drugs
Description

shock; drug | Symptoms Anaphylactoid Drug-induced

Data type

boolean

Alias
UMLS CUI [1]
C0858807
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1706805
UMLS CUI [2,3]
C0458082
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Similar models

Eligibility Schizophrenia NCT00862992

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
patients meeting dsm-iv-tr criteria for schizophrenia
boolean
C0036341 (UMLS CUI [1])
PANSS
Item
panss total score <= 120 during the observation period
boolean
C4086747 (UMLS CUI [1])
Antipsychotic Agents Oral
Item
patients who have been treated with oral antipsychotics within 4 weeks before informed consent
boolean
C0040615 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Informed Consent
Item
patients whose consent is obtained from themselves in written form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Mental disorders | Exception Schizophrenia
Item
patients who have defined as any mental disorder other than "schizophrenia" based on the criteria of dsm-iv-tr
boolean
C0004936 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
Substance Use Disorders
Item
history of drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Parkinson Disease
Item
concurrent parkinson's disease
boolean
C0030567 (UMLS CUI [1])
Disease Spastic | Epilepsy | Cerebrovascular Disorders | Anuria | Paralytic Ileus | Malignant syndrome | Diabetes Mellitus | Liver disease
Item
history of, or concurrent spastic disorders like epilepsy, cerebrovascular disease, anuresis or adynamic(= paralytic) ileus, malignant syndrome, diabetes, hepatic disorder
boolean
C0012634 (UMLS CUI [1,1])
C0443306 (UMLS CUI [1,2])
C0014544 (UMLS CUI [2])
C0007820 (UMLS CUI [3])
C0003460 (UMLS CUI [4])
C0030446 (UMLS CUI [5])
C0948281 (UMLS CUI [6])
C0011849 (UMLS CUI [7])
C0023895 (UMLS CUI [8])
Physical examination abnormal | Abnormal vital signs | ECG abnormal | Laboratory test result abnormal
Item
patients who exhibit abnormalities on physical examination, have abnormal vital signs, ecg, or clinical laboratory values
boolean
C0747585 (UMLS CUI [1])
C0277804 (UMLS CUI [2])
C0522055 (UMLS CUI [3])
C0438215 (UMLS CUI [4])
Cataract
Item
current cataract during the observation period
boolean
C0086543 (UMLS CUI [1])
shock; drug | Symptoms Anaphylactoid Drug-induced
Item
history of shock or anaphylactoid symptoms to drugs
boolean
C0858807 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C1706805 (UMLS CUI [2,2])
C0458082 (UMLS CUI [2,3])
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