Informações:
Falhas:
ID
32131
Descrição
Efficacy Study Exploring the Effect of Lu AE58054 as Augmentation Therapy in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00810667
Link
https://clinicaltrials.gov/show/NCT00810667
Palavras-chave
Versões (1)
- 20/10/2018 20/10/2018 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
20 de outubro de 2018
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00810667
Eligibility Schizophrenia NCT00810667
- StudyEvent: Eligibility
Similar models
Eligibility Schizophrenia NCT00810667
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Schizophrenia Primary
Item
primary diagnosis of schizophrenia
boolean
C0036341 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,2])
Age
Item
man or woman, aged between 18-65
boolean
C0001779 (UMLS CUI [1])
Risperidone Dose U/day | Therapy Schizophrenia
Item
patient is on an optimised dose of risperidone (within 4-8 mg/day) for the treatment of schizophrenia for a minimum of 4 weeks prior to screening
boolean
C0073393 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
PANSS
Item
the patient has a panss total score between 70 and 100 (extremes included) at screening
boolean
C4086747 (UMLS CUI [1])
Psychiatric Diagnosis Primary | Eception Schizophrenia
Item
primary psychiatric diagnosis other than schizophrenia
boolean
C0376338 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
C0205225 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
Acute exacerbation Hospitalization Required
Item
acute exacerbation requiring hospitalisation within the last 3 months
boolean
C0743630 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
C1708385 (UMLS CUI [1,2])
Extrapyramidal symptoms
Item
clinically significant extrapyramidal symptoms
boolean
C0234133 (UMLS CUI [1])
Cardiovascular Disease | Congestive heart failure | Cardiac Hypertrophy | Cardiac Arrhythmia | Bradycardia
Item
clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia
boolean
C0007222 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C1383860 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
C0428977 (UMLS CUI [5])
C0018802 (UMLS CUI [2])
C1383860 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
C0428977 (UMLS CUI [5])
ECG abnormal
Item
significant ecg abnormalities
boolean
C0522055 (UMLS CUI [1])
CYP2D6 Inhibitors | Cytochrome P450 Inhibitors
Item
in concurrent treatment with drugs inhibiting the p450 enzymes system cyp2d6 and other cyp isozymes
boolean
C3850058 (UMLS CUI [1])
C0010762 (UMLS CUI [2,1])
C0243077 (UMLS CUI [2,2])
C0010762 (UMLS CUI [2,1])
C0243077 (UMLS CUI [2,2])
Risperidone Courses failed
Item
failed to respond to adequate courses of treatment with risperidone
boolean
C0073393 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0750729 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Antipsychotic Agent | Exception Risperidone
Item
treated with an antipsychotic other than risperidone within 4 weeks prior to screening
boolean
C0040615 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0073393 (UMLS CUI [2,2])
C1705847 (UMLS CUI [2,1])
C0073393 (UMLS CUI [2,2])