ID

32257

Descripción

Artemisinin With Risperidone for First-Episode and Drug-Naive Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01391403

Link

https://clinicaltrials.gov/show/NCT01391403

Palabras clave

Versiones (1)
  1. 24/10/18 24/10/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

24 de octubre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01391403

Inglés

Eligibility Schizophrenia NCT01391403

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
currently resides in beijing, china
Descripción

Residence China

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0008115
diagnosis of schizophrenia or schizophreniform disorder
Descripción

Schizophrenia | Schizophreniform Disorder

Tipo de datos

boolean

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

Symptoms duration

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0436359
no history of treatment with antipsychotic medication or, if previously treated, a total lifetime usage of less than 14 days
Descripción

Antipsychotic Agents Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0332197
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)
Descripción

Psychotic symptoms Moderate | Brief Psychiatric Rating Scale

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0871189
UMLS CUI [1,2]
C0205081
UMLS CUI [2]
C0029941
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
dsm-iv axis i diagnosis other than schizophrenia or schizophreniform psychosis
Descripción

Axis I diagnosis | Exception Schizophrenia | Exception Schizophreniform psychosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036341
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0865304
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)
Descripción

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

Tipo de datos

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)
Descripción

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

Tipo de datos

boolean

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

Echocardiogram abnormal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0476369
pregnant or breastfeeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

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

Therapy Illicit

Tipo de datos

boolean

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

Severe allergy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2945656
dependence on alcohol or illegal drugs
Descripción

Alcoholic Intoxication, Chronic | Illicit Drugs Dependence Addictive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2,1]
C0086190
UMLS CUI [2,2]
C0085281
use of any of the following medications during the trial: antipsychotic medications other than risperidone; psychostimulants; or antidepressants
Descripción

Antipsychotic Agents | Exception Risperidone | Psychostimulant | Antidepressive Agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0073393
UMLS CUI [3]
C0304403
UMLS CUI [4]
C0003289
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Similar models

Eligibility Schizophrenia NCT01391403

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Residence China
Item
currently resides in beijing, china
boolean
C0237096 (UMLS CUI [1,1])
C0008115 (UMLS CUI [1,2])
Schizophrenia | Schizophreniform Disorder
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
C0436359 (UMLS CUI [1])
Antipsychotic Agents Absent
Item
no history of treatment with antipsychotic medication or, if previously treated, a total lifetime usage of less than 14 days
boolean
C0040615 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Psychotic symptoms Moderate | 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 [2])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis | Exception Schizophrenia | Exception Schizophreniform psychosis
Item
dsm-iv axis i diagnosis other than schizophrenia or schizophreniform psychosis
boolean
C0270287 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0865304 (UMLS CUI [3,2])
CNS disorder Interferes with 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 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 [1,1])
C0443343 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3])
C0342302 (UMLS CUI [4])
C1868885 (UMLS CUI [5])
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])
Therapy Illicit
Item
use of prohibited concomitant therapy
boolean
C0087111 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
Severe allergy
Item
history of severe allergy or hypersensitivity
boolean
C2945656 (UMLS CUI [1])
Alcoholic Intoxication, Chronic | Illicit Drugs Dependence Addictive
Item
dependence on alcohol or illegal drugs
boolean
C0001973 (UMLS CUI [1])
C0086190 (UMLS CUI [2,1])
C0085281 (UMLS CUI [2,2])
Antipsychotic Agents | Exception Risperidone | 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])
C1705847 (UMLS CUI [2,1])
C0073393 (UMLS CUI [2,2])
C0304403 (UMLS CUI [3])
C0003289 (UMLS CUI [4])
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