ID

37169

Beschreibung

Oxytocin as Adjunctive Therapy for Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01699997

Link

https://clinicaltrials.gov/show/NCT01699997

Stichworte

Versionen (1)
  1. 05.07.19 05.07.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

5. Juli 2019

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 NCT01699997

Englisch

Eligibility Schizophrenia NCT01699997

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with a diagnosis of sz, according to dsm-iv criteria, for at least one year, evaluated with scid/p
Beschreibung

Schizophrenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0036341
a minimum panss total score of 55 (indicating moderate severity, due to ongoing ap treatment) .
Beschreibung

PANSS Clinical Classification | Antipsychotic Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C4086747
UMLS CUI [2]
C0040615
a minimum cgi-s score of 4
Beschreibung

Clinical global impression scale

Datentyp

boolean

Alias
UMLS CUI [1]
C3639708
age between 18 and 45 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
a disorder duration of no longer than 10 years
Beschreibung

Disease length

Datentyp

boolean

Alias
UMLS CUI [1]
C0872146
women of childbearing age must test negative for pregnancy at the time of enrolment.
Beschreibung

Childbearing Potential Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
all patients must:
Beschreibung

Patients All

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0444868
be on a therapeutic dose of a sga (or a maximum 2 sgas) with no major dose changes for at least 4 weeks.
Beschreibung

Antipsychotic Agents Generation second | Antipsychotic Agents Dose Therapeutic | Antipsychotic Agents Quantity | Change in drug dosage Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0079411
UMLS CUI [1,3]
C0205436
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0302350
UMLS CUI [3,1]
C0040615
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0420247
UMLS CUI [4,2]
C0332197
have the ability to provide informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
be able to use a nasal spray
Beschreibung

Use of Nasal spray

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C2825048
reside in the service catchment area
Beschreibung

Residence Nearby

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C1706276
show evidence of no alcohol or substance dependence in the last year
Beschreibung

Substance Dependence Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038580
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of mental retardation
Beschreibung

Mental Retardation

Datentyp

boolean

Alias
UMLS CUI [1]
C0025362
diagnosis of organic mental disorder
Beschreibung

Organic mental disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0029227
history of no response to treatment with clozapine
Beschreibung

Clozapine Response Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009079
UMLS CUI [1,2]
C1704632
UMLS CUI [1,3]
C0332197
history of hypersensitivity to oxt or vehicle
Beschreibung

Oxytocin allergy | Hypersensitivity Oxytocin vehicle

Datentyp

boolean

Alias
UMLS CUI [1]
C0571729
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0030095
UMLS CUI [2,3]
C0042444
alcohol or substance dependence in the last year
Beschreibung

Substance Dependence

Datentyp

boolean

Alias
UMLS CUI [1]
C0038580
presence of, or history of clinically significant allergic rhinitis as assessed by the treating clinician
Beschreibung

Allergic rhinitis

Datentyp

boolean

Alias
UMLS CUI [1]
C2607914
being pregnant or breastfeeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
having given birth in the past 6 months or breast-feeding in the past 3 months
Beschreibung

Birth | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0005615
UMLS CUI [2]
C0006147
low literacy as indicated by an inability to read and understand the consent form
Beschreibung

Low-level literacy | Lacking Able to read Consent Form | Consent Form Comprehension Unable

Datentyp

boolean

Alias
UMLS CUI [1]
C1401894
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C0586740
UMLS CUI [2,3]
C0009797
UMLS CUI [3,1]
C0009797
UMLS CUI [3,2]
C0162340
UMLS CUI [3,3]
C1299582
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Schizophrenia NCT01699997

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
patients with a diagnosis of sz, according to dsm-iv criteria, for at least one year, evaluated with scid/p
boolean
C0036341 (UMLS CUI [1])
PANSS Clinical Classification | Antipsychotic Agents
Item
a minimum panss total score of 55 (indicating moderate severity, due to ongoing ap treatment) .
boolean
C4086747 (UMLS CUI [1])
C0040615 (UMLS CUI [2])
Clinical global impression scale
Item
a minimum cgi-s score of 4
boolean
C3639708 (UMLS CUI [1])
Age
Item
age between 18 and 45 years
boolean
C0001779 (UMLS CUI [1])
Disease length
Item
a disorder duration of no longer than 10 years
boolean
C0872146 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
women of childbearing age must test negative for pregnancy at the time of enrolment.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Patients All
Item
all patients must:
boolean
C0030705 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Antipsychotic Agents Generation second | Antipsychotic Agents Dose Therapeutic | Antipsychotic Agents Quantity | Change in drug dosage Absent
Item
be on a therapeutic dose of a sga (or a maximum 2 sgas) with no major dose changes for at least 4 weeks.
boolean
C0040615 (UMLS CUI [1,1])
C0079411 (UMLS CUI [1,2])
C0205436 (UMLS CUI [1,3])
C0040615 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0302350 (UMLS CUI [2,3])
C0040615 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0420247 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Informed Consent
Item
have the ability to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Use of Nasal spray
Item
be able to use a nasal spray
boolean
C1524063 (UMLS CUI [1,1])
C2825048 (UMLS CUI [1,2])
Residence Nearby
Item
reside in the service catchment area
boolean
C0237096 (UMLS CUI [1,1])
C1706276 (UMLS CUI [1,2])
Substance Dependence Absent
Item
show evidence of no alcohol or substance dependence in the last year
boolean
C0038580 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Mental Retardation
Item
diagnosis of mental retardation
boolean
C0025362 (UMLS CUI [1])
Organic mental disorder
Item
diagnosis of organic mental disorder
boolean
C0029227 (UMLS CUI [1])
Clozapine Response Absent
Item
history of no response to treatment with clozapine
boolean
C0009079 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Oxytocin allergy | Hypersensitivity Oxytocin vehicle
Item
history of hypersensitivity to oxt or vehicle
boolean
C0571729 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0030095 (UMLS CUI [2,2])
C0042444 (UMLS CUI [2,3])
Substance Dependence
Item
alcohol or substance dependence in the last year
boolean
C0038580 (UMLS CUI [1])
Allergic rhinitis
Item
presence of, or history of clinically significant allergic rhinitis as assessed by the treating clinician
boolean
C2607914 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
being pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Birth | Breast Feeding
Item
having given birth in the past 6 months or breast-feeding in the past 3 months
boolean
C0005615 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Low-level literacy | Lacking Able to read Consent Form | Consent Form Comprehension Unable
Item
low literacy as indicated by an inability to read and understand the consent form
boolean
C1401894 (UMLS CUI [1])
C0332268 (UMLS CUI [2,1])
C0586740 (UMLS CUI [2,2])
C0009797 (UMLS CUI [2,3])
C0009797 (UMLS CUI [3,1])
C0162340 (UMLS CUI [3,2])
C1299582 (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