ID

35887

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02442739

Nyckelord

Versioner (1)
  1. 2019-04-02 2019-04-02 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

2 april 2019

DOI

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Creative Commons BY 4.0
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Eligibility Head and Neck Cancer NCT02442739

Engelsk

Eligibility Head and Neck Cancer NCT02442739

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Informed Consent

Datatyp

boolean

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

Squamous cell carcinoma of the head and neck TNM clinical staging

Datatyp

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.
Beskrivning

Curative treatment Head and Neck Carcinoma

Datatyp

boolean

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

Age

Datatyp

boolean

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

Liver function

Datatyp

boolean

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

Alanine aminotransferase measurement

Datatyp

boolean

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

Aspartate aminotransferase measurement

Datatyp

boolean

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

Serum total bilirubin measurement

Datatyp

boolean

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

Racial group All | Ethnic group All

Datatyp

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.
Beskrivning

Antidepressive Agents Dose unchanged

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Exclusion Criteria

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

Study Subject Participation Status | Investigational New Drugs

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Moderate depression QIDS-SR | Severe depression QIDS-SR

Datatyp

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.
Beskrivning

Suicide risk assessment Score

Datatyp

boolean

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

Monoamine Oxidase Inhibitors

Datatyp

boolean

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

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

Datatyp

boolean

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

Allergic Reaction Ketamine | Ketamine allergy

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Tachyarrhythmia | Angina Pectoris Severe | Myocardial Ischemia

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

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

Eligibility Head and Neck Cancer NCT02442739

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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