ID

32310

Beschreibung

An Observational Study to Evaluate Efficacy and Safety of Risperidone Long-Acting Injection for Treatment of Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01894984

Link

https://clinicaltrials.gov/show/NCT01894984

Stichworte

Versionen (1)
  1. 26.10.18 26.10.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

26. Oktober 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01894984

Englisch

Eligibility Schizophrenia NCT01894984

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, age 18-65 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
participant must meet the diagnostic criteria for schizophrenia or schizophreniform disorder according to diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv)-tm
Beschreibung

Schizophrenia | Schizophreniform Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036358
total course of disease no more than 5 years
Beschreibung

Disease length

Datentyp

boolean

Alias
UMLS CUI [1]
C0872146
according to physician's discretion, participants need to be changed to risperidone long-acting injection and other atypical anti-psychotic drug
Beschreibung

Risperidone Injection Active Long-term | Atypical antipsychotic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4084406
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0443252
UMLS CUI [2]
C1276996
participant or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Beschreibung

Informed Consent | Informed Consent Patient Representatives | Comprehension Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
UMLS CUI [3,1]
C0162340
UMLS CUI [3,2]
C2348563
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant risk of suicidal or violent behavior, as clinically assessed by the investigator
Beschreibung

At risk Suicidal behavior | At risk Physical aggression

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1444641
UMLS CUI [1,2]
C1760428
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0424323
have aggressive behavior and excited , restless
Beschreibung

Aggressive behavior | Behavior Excited | Restless behavior

Datentyp

boolean

Alias
UMLS CUI [1]
C0001807
UMLS CUI [2,1]
C0004927
UMLS CUI [2,2]
C3833702
UMLS CUI [3]
C0237280
history or current symptoms of tardive dyskinesia; neuroleptic malignant syndrome; evidence of dysfunction of liver and kidney and other severe physical diseases; and severe, life-threatening allergic reaction to any drug
Beschreibung

Tardive Dyskinesia | Symptoms Tardive Dyskinesia | Neuroleptic Malignant Syndrome | Liver Dysfunction | Abnormal renal function | Physical illness Severe | Drug Allergy Severe Life Threatening

Datentyp

boolean

Alias
UMLS CUI [1]
C0686347
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0686347
UMLS CUI [3]
C0027849
UMLS CUI [4]
C0086565
UMLS CUI [5]
C0151746
UMLS CUI [6,1]
C0683323
UMLS CUI [6,2]
C0205082
UMLS CUI [7,1]
C0013182
UMLS CUI [7,2]
C0205082
UMLS CUI [7,3]
C2826244
known hypersensitivity to risperidone
Beschreibung

Risperidone allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0570837
female participant who is pregnant or breastfeeding or planning to become pregnant during the study period
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
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Ähnliche Modelle

Eligibility Schizophrenia NCT01894984

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female, age 18-65 years
boolean
C0001779 (UMLS CUI [1])
Schizophrenia | Schizophreniform Disorders
Item
participant must meet the diagnostic criteria for schizophrenia or schizophreniform disorder according to diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv)-tm
boolean
C0036341 (UMLS CUI [1])
C0036358 (UMLS CUI [2])
Disease length
Item
total course of disease no more than 5 years
boolean
C0872146 (UMLS CUI [1])
Risperidone Injection Active Long-term | Atypical antipsychotic
Item
according to physician's discretion, participants need to be changed to risperidone long-acting injection and other atypical anti-psychotic drug
boolean
C4084406 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
C1276996 (UMLS CUI [2])
Informed Consent | Informed Consent Patient Representatives | Comprehension Study Protocol
Item
participant or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
C0162340 (UMLS CUI [3,1])
C2348563 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
At risk Suicidal behavior | At risk Physical aggression
Item
significant risk of suicidal or violent behavior, as clinically assessed by the investigator
boolean
C1444641 (UMLS CUI [1,1])
C1760428 (UMLS CUI [1,2])
C1444641 (UMLS CUI [2,1])
C0424323 (UMLS CUI [2,2])
Aggressive behavior | Behavior Excited | Restless behavior
Item
have aggressive behavior and excited , restless
boolean
C0001807 (UMLS CUI [1])
C0004927 (UMLS CUI [2,1])
C3833702 (UMLS CUI [2,2])
C0237280 (UMLS CUI [3])
Tardive Dyskinesia | Symptoms Tardive Dyskinesia | Neuroleptic Malignant Syndrome | Liver Dysfunction | Abnormal renal function | Physical illness Severe | Drug Allergy Severe Life Threatening
Item
history or current symptoms of tardive dyskinesia; neuroleptic malignant syndrome; evidence of dysfunction of liver and kidney and other severe physical diseases; and severe, life-threatening allergic reaction to any drug
boolean
C0686347 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0686347 (UMLS CUI [2,2])
C0027849 (UMLS CUI [3])
C0086565 (UMLS CUI [4])
C0151746 (UMLS CUI [5])
C0683323 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0013182 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C2826244 (UMLS CUI [7,3])
Risperidone allergy
Item
known hypersensitivity to risperidone
boolean
C0570837 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
female participant who is pregnant or breastfeeding or planning to become pregnant during the study period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
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