ID

37169

Descripción

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

Link

https://clinicaltrials.gov/show/NCT01699997

Palabras clave

Versiones (1)
  1. 5/7/19 5/7/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

5 de julio de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Schizophrenia NCT01699997

Inglés

Eligibility Schizophrenia NCT01699997

1 formularios  
Inclusion Criteria
Descripción

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
Descripción

Schizophrenia

Tipo de datos

boolean

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

PANSS Clinical Classification | Antipsychotic Agents

Tipo de datos

boolean

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

Clinical global impression scale

Tipo de datos

boolean

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

Age

Tipo de datos

boolean

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

Disease length

Tipo de datos

boolean

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

Childbearing Potential Pregnancy test negative

Tipo de datos

boolean

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

Patients All

Tipo de datos

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.
Descripción

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

Tipo de datos

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
Descripción

Informed Consent

Tipo de datos

boolean

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

Use of Nasal spray

Tipo de datos

boolean

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

Residence Nearby

Tipo de datos

boolean

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

Substance Dependence Absent

Tipo de datos

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of mental retardation
Descripción

Mental Retardation

Tipo de datos

boolean

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

Organic mental disorder

Tipo de datos

boolean

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

Clozapine Response Absent

Tipo de datos

boolean

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

Oxytocin allergy | Hypersensitivity Oxytocin vehicle

Tipo de datos

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
Descripción

Substance Dependence

Tipo de datos

boolean

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

Allergic rhinitis

Tipo de datos

boolean

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

Pregnancy | Breast Feeding

Tipo de datos

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
Descripción

Birth | Breast Feeding

Tipo de datos

boolean

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

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

Tipo de datos

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
Volver a la parte superior de la página

Similar models

Eligibility Schizophrenia NCT01699997

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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