ID

23131

Beskrivning

Effectiveness of Tropisetron Plus Risperidone for Improving Cognitive and Perceptual Disturbances in Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00435370

Länk

https://clinicaltrials.gov/show/NCT00435370

Nyckelord

Versioner (2)
  1. 2017-06-25 2017-06-25 -
  2. 2017-06-25 2017-06-25 -
Uppladdad den

25 juni 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Smoking Cessation NCT00435370

Engelsk

Eligibility Smoking Cessation NCT00435370

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
currently resides in beijing, china
Beskrivning

Residence

Datatyp

boolean

Alias
UMLS CUI [1]
C0237096
diagnosis of schizophrenia or schizophreniform disorder
Beskrivning

Schizophrenia | Schizophreniform Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036358
duration of symptoms is no longer than 60 months
Beskrivning

Symptoms Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0449238
no history of treatment with antipsychotic medication or, if previously treated, a total lifetime usage of less than 14 days
Beskrivning

Antipsychotic drug therapy Absent | Antipsychotic drug therapy short-term

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1319421
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1319421
UMLS CUI [2,2]
C0443303
current psychotic symptoms are of moderate severity or greater as measured by one of the five psychotic items in the brief psychiatric rating scale (bprs)
Beskrivning

Psychotic symptom Moderate Brief Psychiatric Rating Scale | Psychotic symptom Severe Brief Psychiatric Rating Scale

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0871189
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C0029941
UMLS CUI [2,1]
C0871189
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0029941
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnostic and statistical manual of mental disorders(dsm)-iv axis i diagnosis other than schizophrenia or schizophreniform psychosis
Beskrivning

Axis I diagnosis | Schizophrenia Excluded | Schizophreniform Disorders Excluded

Datatyp

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2,1]
C0036341
UMLS CUI [2,2]
C2828389
UMLS CUI [3,1]
C0036358
UMLS CUI [3,2]
C2828389
documented disease of the central nervous system that might interfere with the trial assessments (e.g., stroke, tumor, parkinson's disease, huntington's disease, seizure disorder, history of brain trauma resulting in significant impairment, chronic infection)
Beskrivning

CNS disorder Interferes with Clinical Trial Assessment | Cerebrovascular accident | Malignant Neoplasms | Parkinson Disease | Huntington Disease | Epilepsy | Traumatic Brain Injury Resulting in Impairment | Chronic infectious disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C1516048
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0006826
UMLS CUI [4]
C0030567
UMLS CUI [5]
C0020179
UMLS CUI [6]
C0014544
UMLS CUI [7,1]
C0876926
UMLS CUI [7,2]
C0332294
UMLS CUI [7,3]
C0221099
UMLS CUI [8]
C0151317
acute, unstable, and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension)
Beskrivning

Illness | Illness Unstable | Illness untreated | Communicable Disease | Unstable diabetes | Uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C0221423
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0332155
UMLS CUI [4]
C0009450
UMLS CUI [5]
C0342302
UMLS CUI [6]
C1868885
a clinically significant echocardiogram (ecg) abnormality in the opinion of the investigator
Beskrivning

Echocardiogram abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C0476369
pregnant or breastfeeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
use of prohibited concomitant therapy
Beskrivning

Therapeutic procedure Illicit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332266
history of severe allergy or hypersensitivity
Beskrivning

Severe allergy | Hypersensitivity Severe

Datatyp

boolean

Alias
UMLS CUI [1]
C2945656
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0205082
dependence on alcohol or illegal drugs
Beskrivning

Substance Dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0038580
use of any of the following medications during the trial: antipsychotic medications other than risperidone; psychostimulants; or antidepressants
Beskrivning

Antipsychotic Agents | Risperidone Excluded | Psychostimulant | Antidepressive Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2,1]
C0073393
UMLS CUI [2,2]
C2828389
UMLS CUI [3]
C0304403
UMLS CUI [4]
C0003289
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Similar models

Eligibility Smoking Cessation NCT00435370

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Residence
Item
currently resides in beijing, china
boolean
C0237096 (UMLS CUI [1])
Schizophrenia | Schizophreniform Disorders
Item
diagnosis of schizophrenia or schizophreniform disorder
boolean
C0036341 (UMLS CUI [1])
C0036358 (UMLS CUI [2])
Symptoms Duration
Item
duration of symptoms is no longer than 60 months
boolean
C1457887 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Antipsychotic drug therapy Absent | Antipsychotic drug therapy short-term
Item
no history of treatment with antipsychotic medication or, if previously treated, a total lifetime usage of less than 14 days
boolean
C1319421 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1319421 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
Psychotic symptom Moderate Brief Psychiatric Rating Scale | Psychotic symptom Severe Brief Psychiatric Rating Scale
Item
current psychotic symptoms are of moderate severity or greater as measured by one of the five psychotic items in the brief psychiatric rating scale (bprs)
boolean
C0871189 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0029941 (UMLS CUI [1,3])
C0871189 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0029941 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis | Schizophrenia Excluded | Schizophreniform Disorders Excluded
Item
diagnostic and statistical manual of mental disorders(dsm)-iv axis i diagnosis other than schizophrenia or schizophreniform psychosis
boolean
C0270287 (UMLS CUI [1])
C0036341 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0036358 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
CNS disorder Interferes with Clinical Trial Assessment | Cerebrovascular accident | Malignant Neoplasms | Parkinson Disease | Huntington Disease | Epilepsy | Traumatic Brain Injury Resulting in Impairment | Chronic infectious disease
Item
documented disease of the central nervous system that might interfere with the trial assessments (e.g., stroke, tumor, parkinson's disease, huntington's disease, seizure disorder, history of brain trauma resulting in significant impairment, chronic infection)
boolean
C0007682 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,4])
C0038454 (UMLS CUI [2])
C0006826 (UMLS CUI [3])
C0030567 (UMLS CUI [4])
C0020179 (UMLS CUI [5])
C0014544 (UMLS CUI [6])
C0876926 (UMLS CUI [7,1])
C0332294 (UMLS CUI [7,2])
C0221099 (UMLS CUI [7,3])
C0151317 (UMLS CUI [8])
Illness | Illness Unstable | Illness untreated | Communicable Disease | Unstable diabetes | Uncontrolled hypertension
Item
acute, unstable, and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension)
boolean
C0221423 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0221423 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
C0009450 (UMLS CUI [4])
C0342302 (UMLS CUI [5])
C1868885 (UMLS CUI [6])
Echocardiogram abnormal
Item
a clinically significant echocardiogram (ecg) abnormality in the opinion of the investigator
boolean
C0476369 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Therapeutic procedure Illicit
Item
use of prohibited concomitant therapy
boolean
C0087111 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
Severe allergy | Hypersensitivity Severe
Item
history of severe allergy or hypersensitivity
boolean
C2945656 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Substance Dependence
Item
dependence on alcohol or illegal drugs
boolean
C0038580 (UMLS CUI [1])
Antipsychotic Agents | Risperidone Excluded | Psychostimulant | Antidepressive Agents
Item
use of any of the following medications during the trial: antipsychotic medications other than risperidone; psychostimulants; or antidepressants
boolean
C0040615 (UMLS CUI [1])
C0073393 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0304403 (UMLS CUI [3])
C0003289 (UMLS CUI [4])
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