ID

19266

Beschreibung

Efficacy and Safety of a Long Acting Anti-Psychotic Versus Placebo in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00101634

Link

https://clinicaltrials.gov/show/NCT00101634

Stichworte

Versionen (1)
  1. 16.12.16 16.12.16 -
Hochgeladen am

16. Dezember 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Schizophrenia NCT00101634

Englisch

Eligibility Schizophrenia NCT00101634

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who meet diagnostic criteria for schizophrenia according to dsm-iv for at least 1 year
Beschreibung

Schizophrenia disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0872146
meet panss score criteria
Beschreibung

Positive and negative syndrome scale criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0451383
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
have body mass index (bmi) of >15.0 kilogram(kg)/meter (m)2.
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have primary active dsm-iv axis i diagnosis other than schizophrenia
Beschreibung

Axis I diagnosis Primary | Schizophrenia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0205225
UMLS CUI [2]
C0036341
have a decrease of >/=25% in the panss score
Beschreibung

Positive and negative syndrome scale Decrease Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0451383
UMLS CUI [1,2]
C0547047
UMLS CUI [1,3]
C0439165
have dsm-iv diagnosis of active substance dependence within 3 months of screening evaluation (nicotine and caffeine dependence are not exclusionary)
Beschreibung

Substance Dependence | Nicotine Dependence | Caffeine dependence

Datentyp

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0028043
UMLS CUI [3]
C1386553
have history of treatment resistance as defined by failure to respond to 2 adequate trials of different antipsychotic medications
Beschreibung

Therapeutic procedure Resistance | Antipsychotic Agents Different Poor response to treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1514892
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C1705242
UMLS CUI [2,3]
C1320680
have any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
Beschreibung

Gastrointestinal stenosis Pathologic Pre-existing Severe | Gastrointestinal stenosis Iatrogenic Pre-existing Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521587
UMLS CUI [1,2]
C1521733
UMLS CUI [1,3]
C2347662
UMLS CUI [1,4]
C0205082
UMLS CUI [2,1]
C0521587
UMLS CUI [2,2]
C0439669
UMLS CUI [2,3]
C2347662
UMLS CUI [2,4]
C0205082
have significant risk of suicidal, homicidal or violent ideation or behavior
Beschreibung

Feeling suicidal Risk Significant | Homicidal thoughts Risk Significant | Violent ideation Risk Significant | Suicidal behavior Risk Significant | Homicidal behavior Risk Significant | Physical aggression Risk Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0424000
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C0750502
UMLS CUI [2,1]
C0455204
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C0750502
UMLS CUI [3,1]
C1868823
UMLS CUI [3,2]
C0035647
UMLS CUI [3,3]
C0750502
UMLS CUI [4,1]
C1760428
UMLS CUI [4,2]
C0035647
UMLS CUI [4,3]
C0750502
UMLS CUI [5,1]
C1828354
UMLS CUI [5,2]
C0035647
UMLS CUI [5,3]
C0750502
UMLS CUI [6,1]
C0424323
UMLS CUI [6,2]
C0035647
UMLS CUI [6,3]
C0750502
current presence of any significant or unstable medication condition
Beschreibung

Pharmaceutical Preparations Condition Significant | Pharmaceutical Preparations Condition Unstable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0348080
UMLS CUI [1,3]
C0750502
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0348080
UMLS CUI [2,3]
C0443343
treatment with any protocol disallowed therapies
Beschreibung

Therapeutic procedure Illicit Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332266
UMLS CUI [1,3]
C2348563
clinically significant result from screening laboratory or ecg.
Beschreibung

Test Result Clinical Significance Screening procedure | Laboratory Test Result Clinically Significant | Test Result Clinical Significance Electrocardiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0220908
UMLS CUI [2]
C2826633
UMLS CUI [3,1]
C0456984
UMLS CUI [3,2]
C2826293
UMLS CUI [3,3]
C1623258
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Schizophrenia NCT00101634

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia disease length
Item
patients who meet diagnostic criteria for schizophrenia according to dsm-iv for at least 1 year
boolean
C0036341 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Positive and negative syndrome scale criteria Fulfill
Item
meet panss score criteria
boolean
C0451383 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Body mass index
Item
have body mass index (bmi) of >15.0 kilogram(kg)/meter (m)2.
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis Primary | Schizophrenia
Item
patients who have primary active dsm-iv axis i diagnosis other than schizophrenia
boolean
C0270287 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0036341 (UMLS CUI [2])
Positive and negative syndrome scale Decrease Percentage
Item
have a decrease of >/=25% in the panss score
boolean
C0451383 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Substance Dependence | Nicotine Dependence | Caffeine dependence
Item
have dsm-iv diagnosis of active substance dependence within 3 months of screening evaluation (nicotine and caffeine dependence are not exclusionary)
boolean
C0038580 (UMLS CUI [1])
C0028043 (UMLS CUI [2])
C1386553 (UMLS CUI [3])
Therapeutic procedure Resistance | Antipsychotic Agents Different Poor response to treatment
Item
have history of treatment resistance as defined by failure to respond to 2 adequate trials of different antipsychotic medications
boolean
C0087111 (UMLS CUI [1,1])
C1514892 (UMLS CUI [1,2])
C0040615 (UMLS CUI [2,1])
C1705242 (UMLS CUI [2,2])
C1320680 (UMLS CUI [2,3])
Gastrointestinal stenosis Pathologic Pre-existing Severe | Gastrointestinal stenosis Iatrogenic Pre-existing Severe
Item
have any severe preexisting 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])
Feeling suicidal Risk Significant | Homicidal thoughts Risk Significant | Violent ideation Risk Significant | Suicidal behavior Risk Significant | Homicidal behavior Risk Significant | Physical aggression Risk Significant
Item
have significant risk of suicidal, homicidal or violent ideation or behavior
boolean
C0424000 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0455204 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
C1868823 (UMLS CUI [3,1])
C0035647 (UMLS CUI [3,2])
C0750502 (UMLS CUI [3,3])
C1760428 (UMLS CUI [4,1])
C0035647 (UMLS CUI [4,2])
C0750502 (UMLS CUI [4,3])
C1828354 (UMLS CUI [5,1])
C0035647 (UMLS CUI [5,2])
C0750502 (UMLS CUI [5,3])
C0424323 (UMLS CUI [6,1])
C0035647 (UMLS CUI [6,2])
C0750502 (UMLS CUI [6,3])
Pharmaceutical Preparations Condition Significant | Pharmaceutical Preparations Condition Unstable
Item
current presence of any significant or unstable medication condition
boolean
C0013227 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C0443343 (UMLS CUI [2,3])
Therapeutic procedure Illicit Study Protocol
Item
treatment with any protocol disallowed therapies
boolean
C0087111 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Test Result Clinical Significance Screening procedure | Laboratory Test Result Clinically Significant | Test Result Clinical Significance Electrocardiography
Item
clinically significant result from screening laboratory or ecg.
boolean
C0456984 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
C2826633 (UMLS CUI [2])
C0456984 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C1623258 (UMLS CUI [3,3])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video