ID

32018

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00535574

Trefwoorden

Versies (1)
  1. 12-10-18 12-10-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

12 oktober 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00535574

Engels

Eligibility Schizophrenia NCT00535574

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Age

Datatype

boolean

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

Schizophrenia | Schizoaffective Disorder

Datatype

boolean

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

Informed Consent

Datatype

boolean

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

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

Datatype

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 ≥
Beschrijving

Absolute neutrophil count | Platelet Count measurement

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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
Beschrijving

Exclusion Criteria

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

Lipids abnormal | Serum fasting triglyceride measurement Normal

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Organic brain disorder | Mental Retardation | Substance Use Disorders

Datatype

boolean

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

Renal Insufficiency

Datatype

boolean

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

Liver Dysfunction

Datatype

boolean

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

Pancreatitis

Datatype

boolean

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

Axis Thyroid Alteration

Datatype

boolean

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

Suicide attempt

Datatype

boolean

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

Cataract

Datatype

boolean

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

Systemic therapy Vitamin A U/day

Datatype

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.
Beschrijving

Hypersensitivity Bexarotene | Hypersensitivity Component Bexarotene

Datatype

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.
Beschrijving

Pregnancy | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
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Similar models

Eligibility Schizophrenia NCT00535574

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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