ID

23110

Beschreibung

A Long-Term Study of JNS007ER in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01561898

Link

https://clinicaltrials.gov/show/NCT01561898

Stichworte

Versionen (1)
  1. 24.06.17 24.06.17 -
Hochgeladen am

24. Juni 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01561898

Englisch

Eligibility Schizophrenia NCT01561898

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients diagnosed with schizophrenia
Beschreibung

Schizophrenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0036341
patients who have given their own consent in writing to participate in the study
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
patients untreated with antipsychotics within 28 days before the screening test
Beschreibung

Antipsychotic Agents Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0332197
patients who have completed study jns007er-jpn-s31, or those who continued the study at least up to the evaluation at 2 weeks and subsequently discontinued the study due to insufficient efficacy
Beschreibung

Clinical Trial Specified Completed | Clinical Trial Continued | Evaluation | Clinical Trial Discontinued | Effectiveness Insufficient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0549178
UMLS CUI [3]
C1261322
UMLS CUI [4,1]
C0008976
UMLS CUI [4,2]
C1444662
UMLS CUI [5,1]
C1280519
UMLS CUI [5,2]
C0231180
patients participating in study jns007er-jpn-s31 and whose ratio of treatment to the evaluation at 2 weeks is ≥75%
Beschreibung

Participation Clinical Trial Specified | Ratio Therapeutic procedure Evaluation Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
UMLS CUI [2,1]
C0456603
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C1261322
UMLS CUI [2,4]
C0439165
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients diagnosed with a mental disease other than schizophrenia
Beschreibung

Mental disorders | Schizophrenia Excluded

Datentyp

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2,1]
C0036341
UMLS CUI [2,2]
C2828389
a total panss score > 120 at baseline
Beschreibung

Positive and negative syndrome scale

Datentyp

boolean

Alias
UMLS CUI [1]
C0451383
substance-related disorders
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
parkinson's disease complications
Beschreibung

Parkinson Disease Complication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0009566
current or a past history of convulsive disease such as epilepsy
Beschreibung

Convulsive disorder | Epilepsy

Datentyp

boolean

Alias
UMLS CUI [1]
C0234972
UMLS CUI [2]
C0014544
current or a past history of cerebrovascular accident
Beschreibung

Cerebrovascular accident

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
diabetes mellitus
Beschreibung

Diabetes Mellitus

Datentyp

boolean

Alias
UMLS CUI [1]
C0011849
significant hepatic or renal impairment
Beschreibung

Hepatic impairment | Renal Insufficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C0948807
UMLS CUI [2]
C1565489
significant cardiovascular disorders
Beschreibung

Cardiovascular Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
abnormal results of hematological examination, blood chemistry test and urinalysis at screening
Beschreibung

Hematology finding abnormal | Blood chemistry abnormal | Urine screening abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0475182
UMLS CUI [2]
C0438258
UMLS CUI [3]
C0438142
pregnant women, breast-feeding mothers, and patients who wish pregnancy during the study period or those whose pregnancy test at screening was positive
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned | Pregnancy test positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4]
C0240802
contraindications to risperidone products
Beschreibung

Medical contraindication Risperidone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0073393
patients who discontinued study jns007er-jpn-s31 due to an adverse event not related to the underlying disease
Beschreibung

Clinical Trial Specified Discontinued Due to Adverse event

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C1444662
UMLS CUI [1,4]
C0678226
UMLS CUI [1,5]
C0877248
patients judged inadequate by the investigator to participate in the study
Beschreibung

Study Subject Participation Status Inadequate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0205412
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Ähnliche Modelle

Eligibility Schizophrenia NCT01561898

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
patients diagnosed with schizophrenia
boolean
C0036341 (UMLS CUI [1])
Informed Consent
Item
patients who have given their own consent in writing to participate in the study
boolean
C0021430 (UMLS CUI [1])
Antipsychotic Agents Absent
Item
patients untreated with antipsychotics within 28 days before the screening test
boolean
C0040615 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Clinical Trial Specified Completed | Clinical Trial Continued | Evaluation | Clinical Trial Discontinued | Effectiveness Insufficient
Item
patients who have completed study jns007er-jpn-s31, or those who continued the study at least up to the evaluation at 2 weeks and subsequently discontinued the study due to insufficient efficacy
boolean
C0008976 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0008976 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C1261322 (UMLS CUI [3])
C0008976 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C1280519 (UMLS CUI [5,1])
C0231180 (UMLS CUI [5,2])
Participation Clinical Trial Specified | Ratio Therapeutic procedure Evaluation Percentage
Item
patients participating in study jns007er-jpn-s31 and whose ratio of treatment to the evaluation at 2 weeks is ≥75%
boolean
C0679823 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C0456603 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0439165 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Mental disorders | Schizophrenia Excluded
Item
patients diagnosed with a mental disease other than schizophrenia
boolean
C0004936 (UMLS CUI [1])
C0036341 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Positive and negative syndrome scale
Item
a total panss score > 120 at baseline
boolean
C0451383 (UMLS CUI [1])
Substance Use Disorders
Item
substance-related disorders
boolean
C0038586 (UMLS CUI [1])
Parkinson Disease Complication
Item
parkinson's disease complications
boolean
C0030567 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
Convulsive disorder | Epilepsy
Item
current or a past history of convulsive disease such as epilepsy
boolean
C0234972 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
Cerebrovascular accident
Item
current or a past history of cerebrovascular accident
boolean
C0038454 (UMLS CUI [1])
Diabetes Mellitus
Item
diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Hepatic impairment | Renal Insufficiency
Item
significant hepatic or renal impairment
boolean
C0948807 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Cardiovascular Diseases
Item
significant cardiovascular disorders
boolean
C0007222 (UMLS CUI [1])
Hematology finding abnormal | Blood chemistry abnormal | Urine screening abnormal
Item
abnormal results of hematological examination, blood chemistry test and urinalysis at screening
boolean
C0475182 (UMLS CUI [1])
C0438258 (UMLS CUI [2])
C0438142 (UMLS CUI [3])
Pregnancy | Breast Feeding | Pregnancy, Planned | Pregnancy test positive
Item
pregnant women, breast-feeding mothers, and patients who wish pregnancy during the study period or those whose pregnancy test at screening was positive
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0240802 (UMLS CUI [4])
Medical contraindication Risperidone
Item
contraindications to risperidone products
boolean
C1301624 (UMLS CUI [1,1])
C0073393 (UMLS CUI [1,2])
Clinical Trial Specified Discontinued Due to Adverse event
Item
patients who discontinued study jns007er-jpn-s31 due to an adverse event not related to the underlying disease
boolean
C0008976 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
C0678226 (UMLS CUI [1,4])
C0877248 (UMLS CUI [1,5])
Study Subject Participation Status Inadequate
Item
patients judged inadequate by the investigator to participate in the study
boolean
C2348568 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
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