ID

35887

Beschrijving

Safety Study of Ketamine for Preventing Depression in Patients Undergoing Treatment for Head and Neck Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02442739

Link

https://clinicaltrials.gov/show/NCT02442739

Trefwoorden

Versies (1)
  1. 02-04-19 02-04-19 -
Houder van rechten

See clinicaltrials.gov

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2 april 2019

DOI

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Creative Commons BY 4.0
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Eligibility Head and Neck Cancer NCT02442739

Engels

Eligibility Head and Neck Cancer NCT02442739

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. ability to understand and the willingness to sign a written informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
2. stage iii or iv epidermoid cancer of the head and neck.
Beschrijving

Squamous cell carcinoma of the head and neck TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C1168401
UMLS CUI [1,2]
C3258246
3. within two weeks of starting or from having started, curative intent therapy for head and neck cancer.
Beschrijving

Curative treatment Head and Neck Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1273390
UMLS CUI [1,2]
C3887461
4. age ≥ 18 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
5. adequate liver function as defined by:
Beschrijving

Liver function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
alt < 5 x institutional upper limit of normal (uln)
Beschrijving

Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201836
ast < 5 x institutional uln
Beschrijving

Aspartate aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
total bilirubin < 5 x institutional uln
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
6. both men and women of all races and ethnic groups are eligible for this trial.
Beschrijving

Racial group All | Ethnic group All

Datatype

boolean

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C0444868
UMLS CUI [2,1]
C0015031
UMLS CUI [2,2]
C0444868
7. use of antidepressants is permitted if dose has been the same for at least 12 weeks prior to study entry.
Beschrijving

Antidepressive Agents Dose unchanged

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0442739
8. women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Beschrijving

Childbearing Potential Contraceptive methods | Gender Partner Childbearing Potential Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0682323
UMLS CUI [2,3]
C3831118
UMLS CUI [2,4]
C0700589
UMLS CUI [3]
C2985296
UMLS CUI [4]
C0004764
UMLS CUI [5]
C0036899
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. receiving another investigational agent on a clinical trial that prohibits participation in other studies of investigational agents.
Beschrijving

Study Subject Participation Status | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
2. meets mini international neuropsychiatric interview (mini) criteria for major depression, schizophrenia, bipolar illness, delirium or psychosis.
Beschrijving

Major Depressive Disorder | Schizophrenia | Bipolar Disorder | Delirium | Psychotic Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0005586
UMLS CUI [4]
C0011206
UMLS CUI [5]
C0033975
3. has moderate to severe depression according to quick inventory of depressive symptomatology-self rated 16 (qids-sr-16) scores of ≥ 11.
Beschrijving

Moderate depression QIDS-SR | Severe depression QIDS-SR

Datatype

boolean

Alias
UMLS CUI [1,1]
C0588007
UMLS CUI [1,2]
C4331197
UMLS CUI [2,1]
C0588008
UMLS CUI [2,2]
C4331197
4. has suicidal risk assessment (sra) scores ≥ 6.
Beschrijving

Suicide risk assessment Score

Datatype

boolean

Alias
UMLS CUI [1,1]
C0558000
UMLS CUI [1,2]
C0449820
5. use of monoamine oxidase inhibitors within 14 days of study entry.
Beschrijving

Monoamine Oxidase Inhibitors

Datatype

boolean

Alias
UMLS CUI [1]
C0026457
6. diagnosed with melanoma or lymphoma cancer of the head and neck.
Beschrijving

Malignant melanoma of head and neck | Malignant lymphoma of head, face, and neck

Datatype

boolean

Alias
UMLS CUI [1]
C0587060
UMLS CUI [2]
C0432556
7. history of allergic reactions or hypersensitivity to ketamine.
Beschrijving

Allergic Reaction Ketamine | Ketamine allergy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0022614
UMLS CUI [2]
C0570631
8. severe cardiac insufficiency (nyha iii or iv), with uncontrolled and/or unstable cardiac or coronary artery disease.
Beschrijving

Heart failure Severe New York Heart Association Classification | Heart Disease Uncontrolled | Heart Disease Unstable | Coronary Artery Disease Uncontrolled | Coronary Artery Disease Unstable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1275491
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C1956346
UMLS CUI [4,2]
C0205318
UMLS CUI [5,1]
C1956346
UMLS CUI [5,2]
C0443343
9. history of significant tachyarrhythmia, severe angina, or myocardial ischemia
Beschrijving

Tachyarrhythmia | Angina Pectoris Severe | Myocardial Ischemia

Datatype

boolean

Alias
UMLS CUI [1]
C0080203
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0151744
10. poorly controlled hypertension (systolic blood pressure > 180 mmhg or diastolic blood pressure > 1000 mmhg), with or without antihypertensives.
Beschrijving

Poor hypertension control | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents | Antihypertensive Agents Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0421190
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4]
C0003364
UMLS CUI [5,1]
C0003364
UMLS CUI [5,2]
C0332197
11. pregnant or nursing.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Head and Neck Cancer NCT02442739

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. ability to understand and the willingness to sign a written informed consent.
boolean
C0021430 (UMLS CUI [1])
Squamous cell carcinoma of the head and neck TNM clinical staging
Item
2. stage iii or iv epidermoid cancer of the head and neck.
boolean
C1168401 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Curative treatment Head and Neck Carcinoma
Item
3. within two weeks of starting or from having started, curative intent therapy for head and neck cancer.
boolean
C1273390 (UMLS CUI [1,1])
C3887461 (UMLS CUI [1,2])
Age
Item
4. age ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
Liver function
Item
5. adequate liver function as defined by:
boolean
C0232741 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
alt < 5 x institutional upper limit of normal (uln)
boolean
C0201836 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
ast < 5 x institutional uln
boolean
C0201899 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin < 5 x institutional uln
boolean
C1278039 (UMLS CUI [1])
Racial group All | Ethnic group All
Item
6. both men and women of all races and ethnic groups are eligible for this trial.
boolean
C0034510 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C0015031 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
Antidepressive Agents Dose unchanged
Item
7. use of antidepressants is permitted if dose has been the same for at least 12 weeks prior to study entry.
boolean
C0003289 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Childbearing Potential Contraceptive methods | Gender Partner Childbearing Potential Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence
Item
8. women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
C0700589 (UMLS CUI [2,4])
C2985296 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Investigational New Drugs
Item
1. receiving another investigational agent on a clinical trial that prohibits participation in other studies of investigational agents.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Major Depressive Disorder | Schizophrenia | Bipolar Disorder | Delirium | Psychotic Disorders
Item
2. meets mini international neuropsychiatric interview (mini) criteria for major depression, schizophrenia, bipolar illness, delirium or psychosis.
boolean
C1269683 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0005586 (UMLS CUI [3])
C0011206 (UMLS CUI [4])
C0033975 (UMLS CUI [5])
Moderate depression QIDS-SR | Severe depression QIDS-SR
Item
3. has moderate to severe depression according to quick inventory of depressive symptomatology-self rated 16 (qids-sr-16) scores of ≥ 11.
boolean
C0588007 (UMLS CUI [1,1])
C4331197 (UMLS CUI [1,2])
C0588008 (UMLS CUI [2,1])
C4331197 (UMLS CUI [2,2])
Suicide risk assessment Score
Item
4. has suicidal risk assessment (sra) scores ≥ 6.
boolean
C0558000 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Monoamine Oxidase Inhibitors
Item
5. use of monoamine oxidase inhibitors within 14 days of study entry.
boolean
C0026457 (UMLS CUI [1])
Malignant melanoma of head and neck | Malignant lymphoma of head, face, and neck
Item
6. diagnosed with melanoma or lymphoma cancer of the head and neck.
boolean
C0587060 (UMLS CUI [1])
C0432556 (UMLS CUI [2])
Allergic Reaction Ketamine | Ketamine allergy
Item
7. history of allergic reactions or hypersensitivity to ketamine.
boolean
C1527304 (UMLS CUI [1,1])
C0022614 (UMLS CUI [1,2])
C0570631 (UMLS CUI [2])
Heart failure Severe New York Heart Association Classification | Heart Disease Uncontrolled | Heart Disease Unstable | Coronary Artery Disease Uncontrolled | Coronary Artery Disease Unstable
Item
8. severe cardiac insufficiency (nyha iii or iv), with uncontrolled and/or unstable cardiac or coronary artery disease.
boolean
C0018801 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0018799 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C1956346 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C1956346 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
Tachyarrhythmia | Angina Pectoris Severe | Myocardial Ischemia
Item
9. history of significant tachyarrhythmia, severe angina, or myocardial ischemia
boolean
C0080203 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0151744 (UMLS CUI [3])
Poor hypertension control | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents | Antihypertensive Agents Absent
Item
10. poorly controlled hypertension (systolic blood pressure > 180 mmhg or diastolic blood pressure > 1000 mmhg), with or without antihypertensives.
boolean
C0421190 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0003364 (UMLS CUI [4])
C0003364 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Pregnancy | Breast Feeding
Item
11. pregnant or nursing.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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