Information:
Fel:
ID
19257
Beskrivning
Safety Study With Paliperidone ER Extended-Release (ER) Tablets in Geriatric Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00085748
Länk
https://clinicaltrials.gov/show/NCT00085748
Nyckelord
Versioner (1)
- 2016-12-15 2016-12-15 -
Uppladdad den
15 december 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00085748
Eligibility Schizophrenia NCT00085748
- StudyEvent: Eligibility
Similar models
Eligibility Schizophrenia NCT00085748
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Age
Item
double-blind phase: 65 years of age or older
boolean
C0001779 (UMLS CUI [1])
Schizophrenia disease length
Item
dsm-iv diagnosis of schizophrenia for at least 1 year
boolean
C0036341 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,2])
Positive and negative syndrome scale
Item
total panss score at screening and baseline between 70 and 120, inclusive
boolean
C0451383 (UMLS CUI [1])
Hospitalization Duration Agreement | Indication Hospitalization Duration
Item
agrees to hospitalization for a minimum of 14 days and for the duration of the study, if clinically indicated
boolean
C0019993 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0680240 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C0019993 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
C0449238 (UMLS CUI [1,2])
C0680240 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C0019993 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Therapeutic procedure Double-Blind Method Complete | Therapeutic procedure Discontinued Lack of Efficacy
Item
open-label treatment phase: completed 6 weeks of the double-blind treatment phase or finished at least 21 days of treatment and discontinued because of lack of efficacy.
boolean
C0087111 (UMLS CUI [1,1])
C0013072 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0235828 (UMLS CUI [2,3])
C0013072 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0235828 (UMLS CUI [2,3])
Axis I diagnosis | Schizophrenia
Item
dsm-iv axis i diagnosis other than schizophrenia
boolean
C0270287 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0036341 (UMLS CUI [2])
Substance Dependence | Nicotine Dependence | Caffeine dependence
Item
dsm-iv diagnosis of substance dependence within the 6 months before screening (nicotine and caffeine dependence are not exclusionary)
boolean
C0038580 (UMLS CUI [1])
C0028043 (UMLS CUI [2])
C1386553 (UMLS CUI [3])
C0028043 (UMLS CUI [2])
C1386553 (UMLS CUI [3])
Tardive Dyskinesia | Neuroleptic Malignant Syndrome
Item
history of tardive dyskinesia or neuroleptic malignant syndrome (nms)
boolean
C0686347 (UMLS CUI [1])
C0027849 (UMLS CUI [2])
C0027849 (UMLS CUI [2])
Gastrointestinal stenosis Pathologic Pre-existing Severe | Gastrointestinal stenosis Iatrogenic Pre-existing Severe
Item
history of any severe preexisting severe gastrointestinal narrowing (pathologic or iatrogenic)
boolean
C0521587 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
C0521587 (UMLS CUI [2,1])
C0439669 (UMLS CUI [2,2])
C2347662 (UMLS CUI [2,3])
C0205082 (UMLS CUI [2,4])
C1521733 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
C0521587 (UMLS CUI [2,1])
C0439669 (UMLS CUI [2,2])
C2347662 (UMLS CUI [2,3])
C0205082 (UMLS CUI [2,4])
Antipsychotic Agents Quantity | Poor response to treatment
Item
previous history of a lack of response (2 adequate trials) to any antipsychotic
boolean
C0040615 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1320680 (UMLS CUI [2])
C1265611 (UMLS CUI [1,2])
C1320680 (UMLS CUI [2])