ID

23110

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT01561898

Keywords

versioni (1)
  1. 24/06/17 24/06/17 -
Caricato su

24 giugno 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Schizophrenia NCT01561898

Inglese

Eligibility Schizophrenia NCT01561898

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients diagnosed with schizophrenia
Descrizione

Schizophrenia

Tipo di dati

boolean

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

Informed Consent

Tipo di dati

boolean

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

Antipsychotic Agents Absent

Tipo di dati

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
Descrizione

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

Tipo di dati

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%
Descrizione

Participation Clinical Trial Specified | Ratio Therapeutic procedure Evaluation Percentage

Tipo di dati

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
Descrizione

Exclusion Criteria

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

Mental disorders | Schizophrenia Excluded

Tipo di dati

boolean

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

Positive and negative syndrome scale

Tipo di dati

boolean

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

Substance Use Disorders

Tipo di dati

boolean

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

Parkinson Disease Complication

Tipo di dati

boolean

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

Convulsive disorder | Epilepsy

Tipo di dati

boolean

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

Cerebrovascular accident

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0038454
diabetes mellitus
Descrizione

Diabetes Mellitus

Tipo di dati

boolean

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

Hepatic impairment | Renal Insufficiency

Tipo di dati

boolean

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

Cardiovascular Diseases

Tipo di dati

boolean

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

Hematology finding abnormal | Blood chemistry abnormal | Urine screening abnormal

Tipo di dati

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
Descrizione

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

Tipo di dati

boolean

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

Medical contraindication Risperidone

Tipo di dati

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
Descrizione

Clinical Trial Specified Discontinued Due to Adverse event

Tipo di dati

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
Descrizione

Study Subject Participation Status Inadequate

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0205412
Ritorna all'inizio della pagina

Similar models

Eligibility Schizophrenia NCT01561898

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial