araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: LigaSure Small Jaw® Versus Conventional Neck Dissection in Head and Neck Cancer Patients

Summary: The aim of this prospective randomized study was to investigate if the LigaSure vessel sealing system can reduce the operation duration and the postoperative drainage amount in patients undergoing neck dissection.

Detailed description: We compared the differences in perioperative and postoperative variables between LigaSure Small Jaw®-assisted and conventional neck dissection in head and neck cancer patients.
  Patients who were scheduled to undergo neck dissection due to head and neck cancer were eligible for this study. After receiving a detailed explanation, all patients signed an informed consent form before randomization. The study group were treated using the LigaSure vessel sealing system (Small Jaw®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection. Relevant data included tumor-related variables, perioperative parameters, postoperative drainage status, postoperative subjective pain, and analgesic consumption amount were recorded and analyzed.

Eligibility: Inclusion Criteria:
  -  Patients aged 20 to 80 years scheduled to receive neck dissection due to head and neck cancer
  Exclusion Criteria:
  -  history of coagulation disorders
  -  prior radiation to the neck
  -  prior neck dissection
  -  declined to participate

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Mid-Atlantic Research Group Single-Operator Cholangioscopic Assessment of Biliary Strictures

Summary: The purpose of this study is to determine if cholangioscopically-directed biopsies provide a higher diagnostic yield for malignancy in the setting of indeterminate biliary strictures when compared to standard means of sampling.

Detailed description: Biliary strictures in the absence of a mass are a clinical challenge, as current accepted means of sampling provide suboptimal accuracy. Both biliary brushings for cytology and fluoroscopically-directed biopsies produce highly-variable results. Endoscopic ultrasound with fine-needle aspiration has also been employed with variable results. An additional modality, using a single-operator cholangioscope during endoscopic retrograde cholangiopancreatography (ERCP) to obtain cholangioscopically-directed biopsies offers promise in increasing the yield of sampling. Initial observational studies have shown an improved diagnostic yield, but the technique has not been tested in a randomized, medical effectiveness study to better characterize its actual clinical impact. We aim to compare the technique of biopsy-on-biopsy derived sampling via single-operator cholangioscopy with standard fluoroscopically-directed biopsies and brushings in a pilot study. We also aim to perform a medical effectiveness study on the early use of single-operator cholangioscopically (SOC) in the evaluation of undiagnosed biliary strictures.

Eligibility: Inclusion Criteria:
  -  Age greater than or equal to 18 years
  -  Presence of indeterminate biliary strictures with clinical indications for ERCP. Strictures are considered indeterminate when evaluation including cross-sectional imaging is non-diagnostic. Patients who have previously undergone ERCP with sampling will be included, as well as those who have not previously undergone ERCP.
  -  Strictures located above the intrapancreatic bile duct
  -  The Subject's physician determines and ERCP is clinically indicated
  -  Able to provide informed consent
  Exclusion Criteria:
  -  Prior enrollment in the study or another study evaluating biliary strictures
  -  Presence of extrahepatic malignancy or previously-diagnosed hepatocellular carcinoma
  -  Pregnancy
  -  At-risk populations including prisoners and mentally challenged
  -  Unwilling to provide informed consent
  -  Medically unfit to undergo ERCP
  -  History of liver transplant

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Mitochondrial Respiratory Function in Mammalian Skeletal Muscle

Summary: The purpose of this study is to determine whether skeletal muscle mitochondrial function is altered in patients with head and neck cancer compared to healthy controls.

Detailed description: 20 men and women, 30-60 years, equally divided between patients diagnosed with advanced (stages III or IV), persistent (recurrence within 6 months) or recurrent head and neck squamous cell carcinoma (HNSCC) (n=10) and healthy age matched control subjects (n=10) will be studied.
  Muscle biopsies will be collected from cancer patients before and after a 4 week standard of care (SOC) treatment. Muscle biopsies from healthy control subjects will be collected at baseline only.
  Lean body mass and fat mass will be determined by a DEXA scan before and after 4 week SOC treatment (cancer patients) to document any change in body composition (cachexia), and at baseline only in the age-matched healthy controls.
  Blood will be collected from both cancer patients and healthy subjects to examine hormone levels at the time of biopsy.

Eligibility: Inclusion Criteria:
  1. Men and women, aged 30-60 years.
  2. Diagnosed with advanced (stages III or IV), persistent (recurrence within 6 months) or recurrent head and neck squamous cell carcinoma (HNSCC) and being treated at UTMB (n=10).
  3. Healthy sex and age matched controls (n=10.)
  4. Able to comprehend risks and sign a consent form.
  5. Fluent in English
  Exclusion Criteria:
  1. Significant renal or heart disease or any acute metabolic disease.
  2. Evidence of hepatitis as indicated by a 3-fold increase in of 2 out of 3 liver enzymes.
  3. Diabetes mellitus or other untreated endocrine disease.
  4. Recent (within 3 months) treatment with anabolic steroids.
  5. Ongoing anticoagulant therapy.
  6. Polycystic ovary syndrome (PCOS) and/or hyperthecosis.
  7. Non-classical adrenal hyperplasia.
  8. Cushing's syndrome.
  9. Pregnancy.
  10. Hyperprolactinoma, hypothyroidism.
  11. Granulocyte Count below 1.5x103/µL
  12. Platelet Count below 150 x 103/µL
  13. White Blood Cell Count below 1.0x103/µL
  14. Hemoglobin below 8.0 g/dL
  15. Organ transplant, HIV, or other criteria deemed immunosuppressing by the PI or study physician.
  16. Any other circumstance deemed exclusionary by the PI or study physician.

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Head and Neck Squamous Cell Carcinoma (HNSCC)PET-CT Pilot Study

Summary: The purpose of this study is to see how useful the information provided from Positron Emission Tomography (PET) scans can be in the actual planning and delivery of radiation treatment to patients who have head and neck cancers. Patients participating in this study, will have (in addition to their routine tests) a PET scan before and during their radiation treatment. Following the intervention, patients will be followed as per standard practice.


Eligibility: Inclusion Criteria:
  -  Non-nasopharynx head and neck mucosal squamous cell carcinoma
  -  Radiologically evident gross disease
  -  Radiotherapy alone for curative intent
  -  Age equal to or more than 18 years old
  -  To be eligible for the second study PET-CT scan: FDG avid tumour (or minimum SUV of 2.5) on the first study PET-CT scan
  Exclusion Criteria:
  -  Nasopharynx cancer
  -  H&N SCC skin
  -  Distant metastases (already known or if found on baseline CT-thorax)
  -  Prior malignancy within the last 5 years (exclude non-H&N SCC, BCC skin)
  -  Prior chemotherapy within the last 5 years or concurrent chemotherapy/EGFR inhibitors
  -  Prior head and neck radiotherapy
  -  Inability to lie supine for study duration
  -  Pregnancy
  -  Inability to provide informed consent

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Treatment and Prevention of Middle Ear Morbidity in Head and Neck Cancer Patients Following Radiotherapy

Summary: To investigate the incidence of tuba dysfunction (TD) and middle ear (ME) morbidity after radiotherapy (RT) to the Head & Neck and test the effect of auto-inflation of the Eustachian tube (ET) on middle ear effusion with a special designed balloon (Otovent®) and thereby better hearing and ear related quality of life after cancer treatment.

Detailed description: Middle ear complications and TD are common following RT to the Head & Neck, where the radiation field involves the ET and ME. These are due to mucositis and swelling in the surrounding pharyngeal tissue and on the long-term fibrosis. The ET is a small channel from the middle ear to the upper part of the pharynx. It is normally closed but briefly opens while swallowing or yawning. The ME pressure then equalizes and optimize sound conduction to the inner ear. If the function of the ET is impaired it can lead to negative pressure and effusion. This causes pain, tinnitus, otitis media with effusion (OME), chronic otitis media (COM) and hearing loss. Last can be none reversible. Almost everyone experience middle ear morbidity short after RT, but on the long-term up to 20 % have chronic otitis media and TD with significant hearing impairment and the need for hearing aid. Conventional treatment with insertion of ventilation tubes in to the tympanic membrane is not recommended for radiation-induced ME problems.
  Methods and materials: The investigators will by randomized controlled trials examine the effect of auto-inflation of the ET on ME morbidity with a custom-made balloon called Otovent®. Examination of the ear is conducted by otoscopy, pure tone and impedance audiometry and questionnaires.

Eligibility: Inclusion Criteria:
  -  Head and neck cancer patients in Zealand region, Capital region and North Jutland region.
  -  Only patients who received or is going to receive radiotherapy or chemoradiotherapy as curative intended treatment.
  -  The irradiated volume involve the nasopharynx.
  Exclusion Criteria:
  -  Patients with documented history of otitis media with effusion or chronic otitis media that is not related to the cancer diagnosis.
  -  Performance status > 3.
  -  Surgery in the middle ear, Eustachian tube and surrounding tissue area. (Biopsies during diagnosis is accepted).

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Study Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Summary: The main purpose of this study is to compare nivolumab and ipilimumab with the Extreme study regimen as first line treatment in patients with recurrent or metastatic squamous cell of the head and neck cancer


Eligibility: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
  Inclusion Criteria:
  -  Histologically confirmed metastatic or recurrent squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx & larynx) that is not amenable to curative therapy.
  -  No prior systemic cancer therapy for recurrent or metastatic disease (except if chemotherapy was part of multimodal treatment completed 6 months prior to enrolment).
  -  Measurable disease detected by imaging exam (CT or MRI).
  -  Have tumor tissue for PD L1 expression testing, and for oropharyngeal cancer have results from testing of HPV p16 status.
  Exclusion Criteria:
  -  Metastatic or recurrent carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma originating from skin and salivary glands or non squamous histologies (eg. mucosal melanoma).
  -  No prior treatment with anti PD1, anti PD L1, anti CTLA 4 antibody or any other antibody or drugs targeting T cell costimulation or checkpoint pathways, or cetuximab or EGFR inhibitors in any treatment setting.
  -  Patients with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder.
  -  Inadequate hematologic, renal or hepatic function.
  Other protocol defined inclusion/exclusion criteria could apply

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: ALDH2 Mutation in Taiwanese Head and Neck Cancer

Summary: The purpose of this study is to evaluate the effect of ALDH2 mutation in radiation associating dermatitis or mucositis in head and neck cancer patients who accept chemoradiation therapy

Detailed description: -  One-site audit. The enrolled subject is confirmed by PIs
  ◦◦Source data is compared to external data sources medical records, either paper or electronic case report forms.
  -  NCI CTCAE v5.0 for AE records
  -  Patient recruitment according to inclusion criteria: 1. Newly diagnosed locally head and neck squamous cell carcinoma; 2. Apply for primary chemoradiation or adjuvant chemoradiation; 3. Signed informed consent
  -  Sample size assessment: 60 subjects will be included in one year for total 120 subjects
  -  Missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results
  -  Fisher's exact test is for category comparison. Kaplan-Meier analysis is for survival analysis. AE grades will be analyzed according to NCI guideline. Two-side p < 0.05 is suggested significant.

Eligibility: Inclusion Criteria:
  -  Age >20, <70
  -  Newly diagnosed head and neck squamous cell carcinoma
  -  Tissue proved
  -  Signed informed consent
  -  Suitable for chemoradiation
  Exclusion Criteria:
  -  Uncontrolled underlying diseases
  -  Allergy to chemotherapy
  -  Uncontrolled skin diseases or mucosa diseases
  -  Previously radiation therapy over head and neck
  -  Combined with other cancer currently

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors

Summary: This is a non-randomized, phase II, open label study of postoperative current chemoradiotherapy for high-risk malignant salivary gland tumors of head and neck.The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy in these patients.


Eligibility: Inclusion Criteria:
  1. Pathologically proven diagnosis of a malignant salivary gland tumor of intermediate or high-grade
  2. Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 5mm) or microscopically positive surgical margin
  3. Surgical resection with curative intent within 8 weeks prior to registration, with no evidence of gross tumor residual
  4. No evidence of distant metastases
  5. No synchronous or concurrent head and neck primary tumors
  6. Karnofsky score over 60
  7. Adequate organ function including the following:
  1. Absolute neutrophil count (ANC) >= 1.5 * 10^9/l
  2. Platelets count >= 100 * 10^9/l
  3. Hemoglobin >= 10 g/dl
  4. AST and ALT <= 2.5 times institutional upper limit of normal (ULN)
  5. Total bilirubin <= 1.5 times institutional ULN
  6. Creatinine clearance >= 50 ml/min
  7. Serum creatine <= 1 times ULN
  8. Signed written informed consent
  Exclusion Criteria:
  1. Evidence of distant metastasis
  2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
  3. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
  4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
  5. Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Utilizing a Multi-gene Testing Approach to Identify Hereditary Pancreatic Cancer

Summary: The primary objective of the study will be to estimate the prevalence of germline mutations in patients who present consecutively within 12 weeks of a confirmed diagnosis of pancreatic ductal adenocarcinoma.

Detailed description: The proposed research is a multi-site prospective and observational plan to investigate the prevalence of germline mutations in patients diagnosed with pancreatic cancer. Thirty two genes will be analyzed, all of which have been associated with an increased risk for cancer. The genes are included on CancerNextTM a multi-gene next generation sequencing and array CGH test. The 32 genes include: APC, ATM, BARD1, BRCA1, BRCA2, BRIP1, BMPR1A, CDH1, CDK4, CDKN2A, CHEK2, EPCAM, GREM1, MLH1, MRE11A, MSH2, MSH6, MUTYH, NBN, NF1, PALB2, PMS2, POLD1, POLE, PTEN, RAD50, RAD51C, RAD51D, SMAD4, SMARCA4, STK11, and TP53 .

Eligibility: Inclusion Criteria:
  -  Male and female patients between the ages of 18 and 89 years of age.
  -  Diagnosed within the previous 12 weeks with histologically or cytologically confirmed PDAC Stage I to IV.
  -  Ability of participant to understand and the willingness to sign a written informed consent document.
  -  Participant must agree to sample collection and genetic testing using the 32 gene test, CancerNextTM and allow the test result to be part of their medical record.
  Exclusion Criteria:
  -  Diagnosed with intraductal papillary mucinous neoplasms, mucinous cystic neoplasms, pancreatic neuroendocrine tumors or dysplasia without PDAC.
  -  Diagnosed with PDAC more than 12 weeks before presenting to the clinical site.
  -  Patients meeting the above enrollment criteria who have had CancerNext performed previously.

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Comparison of the Cuff Pressure Between a Taper-guard Cuffed Tube and a Cylindrical-shaped Cuffed Tube

Summary: Endotracheal pressure with different cuff shapes can result in different cuff pressure change after head positional change. In this study, 52 patients underwent middle ear surgery with general anesthesia were randomly allocated to two group; patients were intubated with taper guard cuffed tube or cylindrical shaped cuffed tube. Anesthesia was maintained with sevoflurane with air/oxygen and remifentanil. The cuff pressure was initially set at 22 centimeters of water in the neural head position and was measured after the change to the 45 degree head rotation. The change of cuff pressure was compared between two groups

Detailed description: Endotracheal pressure with different cuff shapes can result in different cuff pressure change after head positional change. In this study, 52 patients underwent middle ear surgery with general anesthesia were randomly allocated to two group; patients were intubated with taper guard cuffed tube or cylindrical shaped cuffed tube. Anesthesia was maintained with sevoflurane with air/O2 and remifentanil. The cuff pressure was initially set at 24 centimeters of water in the neural head position and was measured after the change to the 45 degree head rotation. In addition, sore throat, hoarseness , dysphagia and cough were recorded 0, 6, 12, 24 hr after surgery. The change of cuff pressure was compared between two groups. The side effects associated with tube were compared between two groups.

Eligibility: Inclusion Criteria:
  -  Patients who underwent middle ear surgery with general anesthesia American Society of Anesthesiology status 1-3
  Exclusion Criteria:
  -  Patient with neck pain Patient with a history of neck surgery Patient with limited movement of neck Patient with body mass index more than 35

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Family Lifestyle Actions and Risk Education Study

Summary: The overall purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of a family-focused behavioral intervention ("FLARE", which stands for Family Lifestyle Actions and Risk Education) that aims to improve adherence to melanoma preventive behaviors among children at elevated risk for the disease.


Eligibility: Inclusion Criteria:
  Children
  -  Are 8-17 years old AND
  -  Are at risk for melanoma due to having a first degree relative with a history of melanoma and/or at least 3 second or third degree relatives on the same side of the family with a history of melanoma AND/OR
  -  Have personally received genetic testing for the CDKN2A/p16 genetic mutation and/or has one or more family members who received CDKN2A/p16 testing
  Adults
  -  Are at least 18 years old AND
  -  Are the primary caregiver for the child participating in the study (defined as the individual who is responsible for daily implementation of health-related tasks for the child) AND
  -  Have at least one child under age 18 who is living in the same household AND
  -  Have a personal history of melanoma and/or family history of melanoma) AND/OR
  -  Have personally received genetic testing for the CDKN2A/p16 genetic mutation and/or has one or more family members who received CDKN2A/p16 testing
  Exclusion Criteria:
  -  Individuals who do not speak, read/write English will be excluded because FLARE involves regular interaction between study staff and research participants in English and completion of study questionnaires and interviews in English

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: One-step Nucleic Acid Amplification for Detecting Lymph Node Metastasis of Head and Neck Squamous Cell Carcinoma

Summary: The investigators main objective is to show that OSNA technique is as accurate as pathological analysis (frozen section / HE staining and immunochemistry) to detect occult lymph node metastasis (micro and macrometastasis).


Eligibility: Inclusion Criteria:
  -  Patient > 18 years old
  -  Head and neck squamous cell carcinoma diagnosed by biopsy
  -  N0 classification (N0: no lymph node invasion on clinical and radiological examination).
  -  Neck dissection or sentinel lymph node biopsy required to treat the patient
  -  ECOG 1,2 or 3
  -  Patient's consent
  Exclusion Criteria:
  -  Patient previously treated by radiotherapy or surgery for head and neck neoplasm.
  -  Contraindication or patient unwillingness to undergo surgical treatment
  -  Incapacitated adults

Relevance to patient case: not relevant