Eligibility Head and Neck Cancer NCT02442739

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StudyEvent: Eligibility
1. Eligibility Head and Neck Cancer NCT02442739

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

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])

Exclusion Criteria

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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Eligibility Head and Neck Cancer NCT02442739