ID

32018

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00535574

Stichworte

Versionen (1)
  1. 12.10.18 12.10.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

12. Oktober 2018

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 NCT00535574

Englisch

Eligibility Schizophrenia NCT00535574

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

boolean

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

Schizophrenia | Schizoaffective Disorder

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

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

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

Datentyp

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 ≥
Beschreibung

Absolute neutrophil count | Platelet Count measurement

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Exclusion Criteria

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

Lipids abnormal | Serum fasting triglyceride measurement Normal

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Organic brain disorder | Mental Retardation | Substance Use Disorders

Datentyp

boolean

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

Renal Insufficiency

Datentyp

boolean

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

Liver Dysfunction

Datentyp

boolean

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

Pancreatitis

Datentyp

boolean

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

Axis Thyroid Alteration

Datentyp

boolean

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

Suicide attempt

Datentyp

boolean

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

Cataract

Datentyp

boolean

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

Systemic therapy Vitamin A U/day

Datentyp

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.
Beschreibung

Hypersensitivity Bexarotene | Hypersensitivity Component Bexarotene

Datentyp

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.
Beschreibung

Pregnancy | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Schizophrenia NCT00535574

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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