ID

32018

Descripción

Bexarotene Augmentation of Antipsychotic Treatment for Chronic Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00535574

Link

https://clinicaltrials.gov/show/NCT00535574

Palabras clave

Versiones (1)
  1. 12/10/18 12/10/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

12 de octubre de 2018

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 NCT00535574

Inglés

Eligibility Schizophrenia NCT00535574

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18-60 years, male or female
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. dsm-iv criteria for schizophrenia, or schizoaffective disorder.
Descripción

Schizophrenia | Schizoaffective Disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
3. ability and willingness to sign informed consent for participation in the study
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
4. stable blood parameters including adequate hematologic function, defined as wbc ≥
Descripción

Blood parameters Stable | Hematologic function | White Blood Cell Count procedure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005767
UMLS CUI [1,2]
C0449381
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0221130
UMLS CUI [3]
C0023508
4.300/μl, absolute neutrophil count ≥3.000/μl (> 50%), and platelet count ≥
Descripción

Absolute neutrophil count | Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
180,000/μl; normal coagulation parameters; bilirubin ≤1.5 times the upper limit of normal (uln); ast/alt ≤ 2.5 × uln; and serum creatinine ≤1.5 mg/dl.
Descripción

Parameters Blood coagulation Normal | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0449381
UMLS CUI [1,2]
C0005778
UMLS CUI [1,3]
C0205307
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201976
5. only patients who had a normal baseline fasting triglyceride (ftg) level will be entered into the study; triglycerides may be normalized before study entry with use of an antilipemic agent.
Descripción

Serum fasting triglyceride level result Normal | Normalization caused by Hypolipidemic Agents allowed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1318355
UMLS CUI [1,2]
C0205307
UMLS CUI [2,1]
C1882115
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0086440
UMLS CUI [2,4]
C0683607
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. lipid abnormalities. fasting triglyceride normal (normalization with an antilipemic allowed prior to study entry).
Descripción

Lipids abnormal | Serum fasting triglyceride measurement Normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0549634
UMLS CUI [2,1]
C0582824
UMLS CUI [2,2]
C0205307
2. leucopenia or neutropenia. hematopoietic: hemoglobin at least 12.5 g/dl; wbc< 4300/μl; absolute neutrophil count < 3000/μl; platelet count < 155,000/μl
Descripción

Leukopenia | Neutropenia | Parameters Hematopoietic | Hemoglobin measurement | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023530
UMLS CUI [2]
C0027947
UMLS CUI [3,1]
C0449381
UMLS CUI [3,2]
C0229601
UMLS CUI [4]
C0518015
UMLS CUI [5]
C0023508
UMLS CUI [6]
C0948762
UMLS CUI [7]
C0032181
3. evidence of organic brain damage, mental retardation, alcohol or drug abuse
Descripción

Organic brain disorder | Mental Retardation | Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4062280
UMLS CUI [2]
C0025362
UMLS CUI [3]
C0038586
4. impairment of renal function
Descripción

Renal Insufficiency

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1565489
5. hepatic dysfunction
Descripción

Liver Dysfunction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086565
6. a history of pancreatitis
Descripción

Pancreatitis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030305
7. thyroid axis alterations
Descripción

Axis Thyroid Alteration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1522496
UMLS CUI [1,2]
C0040132
UMLS CUI [1,3]
C1515926
8. suicide attempt in past year.
Descripción

Suicide attempt

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038663
9. cataracts.
Descripción

Cataract

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086543
10. systemic treatment with more than 15,000 iu of vitamin a daily.
Descripción

Systemic therapy Vitamin A U/day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0042839
UMLS CUI [1,3]
C0456683
11. patients with a known hypersensitivity to bexarotene or other components of the product.
Descripción

Hypersensitivity Bexarotene | Hypersensitivity Component Bexarotene

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0765273
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1705248
UMLS CUI [2,3]
C0765273
12. pregnant women or a woman who intends to become pregnant.
Descripción

Pregnancy | Pregnancy, Planned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
Volver a la parte superior de la página

Similar models

Eligibility Schizophrenia NCT00535574

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age 18-60 years, male or female
boolean
C0001779 (UMLS CUI [1])
Schizophrenia | Schizoaffective Disorder
Item
2. dsm-iv criteria for schizophrenia, or schizoaffective disorder.
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
Informed Consent
Item
3. ability and willingness to sign informed consent for participation in the study
boolean
C0021430 (UMLS CUI [1])
Blood parameters Stable | Hematologic function | White Blood Cell Count procedure
Item
4. stable blood parameters including adequate hematologic function, defined as wbc ≥
boolean
C0005767 (UMLS CUI [1,1])
C0449381 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0221130 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
Absolute neutrophil count | Platelet Count measurement
Item
4.300/μl, absolute neutrophil count ≥3.000/μl (> 50%), and platelet count ≥
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Parameters Blood coagulation Normal | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum
Item
180,000/μl; normal coagulation parameters; bilirubin ≤1.5 times the upper limit of normal (uln); ast/alt ≤ 2.5 × uln; and serum creatinine ≤1.5 mg/dl.
boolean
C0449381 (UMLS CUI [1,1])
C0005778 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Serum fasting triglyceride level result Normal | Normalization caused by Hypolipidemic Agents allowed
Item
5. only patients who had a normal baseline fasting triglyceride (ftg) level will be entered into the study; triglycerides may be normalized before study entry with use of an antilipemic agent.
boolean
C1318355 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C1882115 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0086440 (UMLS CUI [2,3])
C0683607 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Lipids abnormal | Serum fasting triglyceride measurement Normal
Item
1. lipid abnormalities. fasting triglyceride normal (normalization with an antilipemic allowed prior to study entry).
boolean
C0549634 (UMLS CUI [1])
C0582824 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
Leukopenia | Neutropenia | Parameters Hematopoietic | Hemoglobin measurement | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement
Item
2. leucopenia or neutropenia. hematopoietic: hemoglobin at least 12.5 g/dl; wbc< 4300/μl; absolute neutrophil count < 3000/μl; platelet count < 155,000/μl
boolean
C0023530 (UMLS CUI [1])
C0027947 (UMLS CUI [2])
C0449381 (UMLS CUI [3,1])
C0229601 (UMLS CUI [3,2])
C0518015 (UMLS CUI [4])
C0023508 (UMLS CUI [5])
C0948762 (UMLS CUI [6])
C0032181 (UMLS CUI [7])
Organic brain disorder | Mental Retardation | Substance Use Disorders
Item
3. evidence of organic brain damage, mental retardation, alcohol or drug abuse
boolean
C4062280 (UMLS CUI [1])
C0025362 (UMLS CUI [2])
C0038586 (UMLS CUI [3])
Renal Insufficiency
Item
4. impairment of renal function
boolean
C1565489 (UMLS CUI [1])
Liver Dysfunction
Item
5. hepatic dysfunction
boolean
C0086565 (UMLS CUI [1])
Pancreatitis
Item
6. a history of pancreatitis
boolean
C0030305 (UMLS CUI [1])
Axis Thyroid Alteration
Item
7. thyroid axis alterations
boolean
C1522496 (UMLS CUI [1,1])
C0040132 (UMLS CUI [1,2])
C1515926 (UMLS CUI [1,3])
Suicide attempt
Item
8. suicide attempt in past year.
boolean
C0038663 (UMLS CUI [1])
Cataract
Item
9. cataracts.
boolean
C0086543 (UMLS CUI [1])
Systemic therapy Vitamin A U/day
Item
10. systemic treatment with more than 15,000 iu of vitamin a daily.
boolean
C1515119 (UMLS CUI [1,1])
C0042839 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Hypersensitivity Bexarotene | Hypersensitivity Component Bexarotene
Item
11. patients with a known hypersensitivity to bexarotene or other components of the product.
boolean
C0020517 (UMLS CUI [1,1])
C0765273 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C0765273 (UMLS CUI [2,3])
Pregnancy | Pregnancy, Planned
Item
12. pregnant women or a woman who intends to become pregnant.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
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