ID

19354

Description

Rosiglitazone for Clozapine Induced Glucose Metabolism Impairment; ODM derived from: https://clinicaltrials.gov/show/NCT00337350

Link

https://clinicaltrials.gov/show/NCT00337350

Keywords

Versions (1)
  1. 12/20/16 12/20/16 -
Uploaded on

December 20, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00337350

English

Eligibility Schizophrenia NCT00337350

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
age 18-65 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of schizophrenia, any subtype, schizoaffective disorder, any subtype or schizophreniform disorder
Description

Schizophrenia Subtype Any | Schizoaffective Disorder Subtype Any | Schizophreniform Disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0449560
UMLS CUI [1,3]
C1552551
UMLS CUI [2,1]
C0036337
UMLS CUI [2,2]
C0449560
UMLS CUI [2,3]
C1552551
UMLS CUI [3]
C0036358
well established compliance with out-patient medications
Description

Outpatients Pharmaceutical Preparations Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0029921
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C3714738
current treatment with clozapine for a minimum of one year
Description

Clozapine

Data type

boolean

Alias
UMLS CUI [1]
C0009079
evidence of insulin resistance: impaired fasting glucose (glucose ≥100 mg/dl) or hyperinsulinemia (fasting insulin ≥ 15 ng/dl) or a homa-ir (homeostasis model assessment for insulin resistance) (fasting glucose x fasting insulin/22.5) ≥2 or a si (insulin sensitivity index)
Description

Insulin Resistance Evidence of | Impaired fasting glucose | Glucose measurement | Hyperinsulinism | fasting insulin level | Homeostasis model assessment Insulin Resistance | Insulin Sensitivity Index

Data type

boolean

Alias
UMLS CUI [1,1]
C0021655
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C1272092
UMLS CUI [3]
C0337438
UMLS CUI [4]
C0020459
UMLS CUI [5]
C2016107
UMLS CUI [6,1]
C1829779
UMLS CUI [6,2]
C0021655
UMLS CUI [7,1]
C0920563
UMLS CUI [7,2]
C0918012
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability to provide informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
current substance abuse
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
significant medical illness, including congestive heart failure, severe cardiovascular disease, renal disease (serum creatinine > 1.5), anemia (hemoglobin < 11.0 gm/dl) or psychiatrically unstable
Description

Illness Significant | Congestive heart failure | Cardiovascular Disease Severe | Kidney Diseases | Creatinine measurement, serum | Anemia | Hemoglobin measurement | Psychiatric Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0018802
UMLS CUI [3,1]
C0007222
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0201976
UMLS CUI [6]
C0002871
UMLS CUI [7]
C0518015
UMLS CUI [8,1]
C0205487
UMLS CUI [8,2]
C0443343
severe hepatic impairment, active liver disease or increased serum transaminase levels (alt>2.0x upper limit of normal) if at any time, alt increases to 2x uln, the subject's participation in the study will be terminated.
Description

Hepatic impairment Severe | Liver diseases | Serum transaminase increased | Alanine aminotransferase measurement | Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0859350
UMLS CUI [4]
C0201836
UMLS CUI [5]
C2348568
women of child bearing potential who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unable | Childbearing Potential Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1299582
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0558080
treatment with agents that induce weight loss
Description

Weight-Loss Agents

Data type

boolean

Alias
UMLS CUI [1]
C0376606
history of diabetes mellitus or thyroid disease
Description

Diabetes Mellitus | Thyroid Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0040128
current treatment with an oral hypoglycemic agent or insulin
Description

Oral hypoglycemic | Insulin

Data type

boolean

Alias
UMLS CUI [1]
C0359086
UMLS CUI [2]
C0021641
known hypersensitivity to rosiglitazone or any of its components
Description

Hypersensitivity rosiglitazone | Hypersensitivity rosiglitazone Component

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0289313
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0289313
UMLS CUI [2,3]
C1705248
fasting glucose >126 mg/dl11. treatment with other atypical antipsychotic agents thought to impair glucose metabolism (olanzapine) or low potency conventional agents (thioridazine, chlorpromazine)
Description

Glucose measurement, fasting | Atypical antipsychotic Impairing Glucose metabolism | olanzapine | Pharmaceutical Preparations conventional Potency low | Thioridazine | Chlorpromazine

Data type

boolean

Alias
UMLS CUI [1]
C0202045
UMLS CUI [2,1]
C1276996
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C0596620
UMLS CUI [3]
C0171023
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0439858
UMLS CUI [4,3]
C0678792
UMLS CUI [4,4]
C0205251
UMLS CUI [5]
C0039943
UMLS CUI [6]
C0008286
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Similar models

Eligibility Schizophrenia NCT00337350

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
male or female
boolean
C0079399 (UMLS CUI [1])
Age
Item
age 18-65 years
boolean
C0001779 (UMLS CUI [1])
Schizophrenia Subtype Any | Schizoaffective Disorder Subtype Any | Schizophreniform Disorder
Item
diagnosis of schizophrenia, any subtype, schizoaffective disorder, any subtype or schizophreniform disorder
boolean
C0036341 (UMLS CUI [1,1])
C0449560 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0036337 (UMLS CUI [2,1])
C0449560 (UMLS CUI [2,2])
C1552551 (UMLS CUI [2,3])
C0036358 (UMLS CUI [3])
Outpatients Pharmaceutical Preparations Compliance
Item
well established compliance with out-patient medications
boolean
C0029921 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C3714738 (UMLS CUI [1,3])
Clozapine
Item
current treatment with clozapine for a minimum of one year
boolean
C0009079 (UMLS CUI [1])
Insulin Resistance Evidence of | Impaired fasting glucose | Glucose measurement | Hyperinsulinism | fasting insulin level | Homeostasis model assessment Insulin Resistance | Insulin Sensitivity Index
Item
evidence of insulin resistance: impaired fasting glucose (glucose ≥100 mg/dl) or hyperinsulinemia (fasting insulin ≥ 15 ng/dl) or a homa-ir (homeostasis model assessment for insulin resistance) (fasting glucose x fasting insulin/22.5) ≥2 or a si (insulin sensitivity index)
boolean
C0021655 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C1272092 (UMLS CUI [2])
C0337438 (UMLS CUI [3])
C0020459 (UMLS CUI [4])
C2016107 (UMLS CUI [5])
C1829779 (UMLS CUI [6,1])
C0021655 (UMLS CUI [6,2])
C0920563 (UMLS CUI [7,1])
C0918012 (UMLS CUI [7,2])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable
Item
inability to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Substance Use Disorders
Item
current substance abuse
boolean
C0038586 (UMLS CUI [1])
Illness Significant | Congestive heart failure | Cardiovascular Disease Severe | Kidney Diseases | Creatinine measurement, serum | Anemia | Hemoglobin measurement | Psychiatric Unstable
Item
significant medical illness, including congestive heart failure, severe cardiovascular disease, renal disease (serum creatinine > 1.5), anemia (hemoglobin < 11.0 gm/dl) or psychiatrically unstable
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C0007222 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0022658 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0002871 (UMLS CUI [6])
C0518015 (UMLS CUI [7])
C0205487 (UMLS CUI [8,1])
C0443343 (UMLS CUI [8,2])
Hepatic impairment Severe | Liver diseases | Serum transaminase increased | Alanine aminotransferase measurement | Study Subject Participation Status
Item
severe hepatic impairment, active liver disease or increased serum transaminase levels (alt>2.0x upper limit of normal) if at any time, alt increases to 2x uln, the subject's participation in the study will be terminated.
boolean
C0948807 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2])
C0859350 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C2348568 (UMLS CUI [5])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unable | Childbearing Potential Contraceptive methods Unwilling
Item
women of child bearing potential who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Weight-Loss Agents
Item
treatment with agents that induce weight loss
boolean
C0376606 (UMLS CUI [1])
Diabetes Mellitus | Thyroid Diseases
Item
history of diabetes mellitus or thyroid disease
boolean
C0011849 (UMLS CUI [1])
C0040128 (UMLS CUI [2])
Oral hypoglycemic | Insulin
Item
current treatment with an oral hypoglycemic agent or insulin
boolean
C0359086 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
Hypersensitivity rosiglitazone | Hypersensitivity rosiglitazone Component
Item
known hypersensitivity to rosiglitazone or any of its components
boolean
C0020517 (UMLS CUI [1,1])
C0289313 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0289313 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
Glucose measurement, fasting | Atypical antipsychotic Impairing Glucose metabolism | olanzapine | Pharmaceutical Preparations conventional Potency low | Thioridazine | Chlorpromazine
Item
fasting glucose >126 mg/dl11. treatment with other atypical antipsychotic agents thought to impair glucose metabolism (olanzapine) or low potency conventional agents (thioridazine, chlorpromazine)
boolean
C0202045 (UMLS CUI [1])
C1276996 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0596620 (UMLS CUI [2,3])
C0171023 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0439858 (UMLS CUI [4,2])
C0678792 (UMLS CUI [4,3])
C0205251 (UMLS CUI [4,4])
C0039943 (UMLS CUI [5])
C0008286 (UMLS CUI [6])
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