araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Safety, Efficacy and Pharmacokinetic of BPI-9016M in Patients With c-Met- Dysregulated Advanced NSCLC

Summary: The main objective of this study is to evaluate the safety, tolerability, efficacy and pharmacokinetics of BPI-9016M in patients with c-Met-dysregulated advanced NSCLC.Biomarkers related to the efficacy of BPI-9016M will be investigated.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed, locally advanced or metastatic NSCLC patients, who is not suitable for surgery or radiotherapy
  -  Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST1.1)
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  -  Life expectancy ≥12 weeks
  -  Must have evidence of positive c-Met protein expression by IHC from either local data or the results of molecular pre-screening evaluations.
  -  Adequate bone marrow, hepatic, and renal function
  -  Patients of child bearing potential must agree to take contraception during the study and for 90 days after the last day of treatment
  -  Signed Informed Consent Form
  Exclusion Criteria:
  -  Prior or current treatment with a c-MET inhibitor or HGF-targeting therapy
  -  Confirmed ALK or ROS1 rearrangement
  -  Prior treatment with targeting agents (Including EGFR tyrosine kinase inhibitors,VEGFR TKIs etc.) within 14 days or 5 half-life
  -  Prior treatment with anticancer agents (Including cytotoxic chemotherapy,radiotherapy, immunotherapy etc.) within 4 weeks
  -  Brain/meninges metastases unless asymptomatic, stable and not requiring steroids for maintenance
  -  History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease, radiological documentation of idiopathic pulmonary fibrosis at baseline; uncontrolled pleural effusion/pericardial effusion
  -  Any evidence of severe or uncontrolled systemic diseases, including CTCAE 2 or higher active infection, unstable angina pectoris, congestive cardiac failure and severe liver/renal or metabolic disease
  -  Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
  -  History of organ transplant; had surgery or severe injury within 4 weeks
  -  Uncontrolled hypertension（Systolic blood pressure≥160mmHg and/or diastolic blood pressure≥100mmHg ）
  -  Patients unable to swallow orally administered medication, prior surgical procedures affecting absorption.
  -  Pregnant (positive pregnancy test) or lactating women

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Study to Evaluate the Benefit of a High Frequency Ventilation System During Lung or Breast Cancer Radiotherapy Treatment

Summary: That study combines High Frequency Percussive Ventilation (HFPV) with radiotherapy treatment in patients with tumors that are moving with respiration like breast or lung cancers. The use of a High Frequency Percussive Ventilation system leads to the cessation of respiratory motions while administering radiotherapy (RT) to tumors which allows a reduction of the amount of irradiated normal tissues and which potentially decrease radiation-induced collateral damages.

Detailed description: Primary objective :
  Demonstrate the clinical benefit of the HFPV coupled to thoracic radiotherapy in 2 distinct and frequent clinical situations :
  1. Tomotherapy for lung and left breast tumors. The investigators assume that the volume of irradiated healthy tissue will be much less when using HFPV as compared to free breathing during tomotherapy sessions .
  2. In comparison with Active Breathing Control (ABC system). The investigators assume that the HFPV will lead to breathing motions cessation the same way as the ABC system, but will abrogate pause times when administrating the radiotherapy. This will shorten the radiotherapy sessions for lung patients treated with stereotaxis and for breast cancer patients.

Eligibility: Inclusion Criteria:
  -  breast cancer eligible for tomotherapy or linear accelerator with ABC system
  -  lung cancer eligible for curative tomotherapy and with breathing movements amplitude >1 cm
  -  lung cancer eligible for ablative stereotaxis
  -  WHO 0 or 1
  Exclusion Criteria:
  -  patients requiring oxygen or not able to lie on the back (dyspnea)
  -  pulmonary functions altered
  -  cardiac insufficiency
  -  patient not able to breathe with the High Frequency Ventilation System
  -  risk of pneumothorax when experiencing High Frequency Ventilation

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: ALK/ROS1/MET Mutations on Plasma ctDNA in Patients With NSCLC

Summary: The study aims to explore the prevalence of ALK/ROS1/MET mutations assessed with ctDNA samples in EGFR-wildtype NSCLC


Eligibility: Inclusion Criteria:
  -  Histologically confirmed stage IIIB/IV NSCLC;
  -  Histologically confirmed adenocarcinoma;
  -  EGFR-wildtype NSCLC;
  -  Provision of blood (plasma) sample for ctDNA testing;
  -  Patient must be able to comply with the protocol;
  -  Provision of blood (plasma) sample for ctDNA testing;
  Exclusion Criteria:
  -  As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease);
  -  Histologically confirmed small cell lung cancer or other metastatic tumors;
  -  Patient with no histologic or cytological diagnosis;

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Effects of Bright Light Therapy on Fatigue, Sleep and Circadian Activity Rhythms in Lung Cancer Survivors

Summary: The purpose of this study is to determine the effects of morning bright light therapy on fatigue, sleep disturbances, and circadian activity rhythms in lung cancer survivors.

Detailed description: A randomized controlled trial to test the effects of morning bright light therapy on fatigue, sleep disturbances, and circadian activity rhythms in lung cancer survivors.

Eligibility: Inclusion Criteria:
  -  Stage I-III Non-small cell lung cancer survivors
  -  Must be at >6-weeks and < 3 years post-surgical resection
  -  Must have diagnosis fatigue and/or sleep disturbances
  Exclusion Criteria:
  -  Individuals clinically unstable.
  -  Mania, Bipolar disease or seizure disorder
  -  Macular degeneration or glaucoma.
  -  Currently receiving chemotherapy or radiation.

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Non-Small Cell Lung Cancer

Summary: The study will evaluate the clinical activity of nivolumab in combination with 3 separate investigational agents, glesatinib, sitravatinib, or mocetinostat.

Detailed description: Glesatinib is an orally administered multi-targeted tyrosine kinase inhibitor (TKI) that primarily targets the Axl and Mesenchymal-Epithelial Transition (MET) receptors. Sitravatinib is an orally-available, potent small molecule inhibitor or a closely related spectrum of receptor tyrosine kinases (RTKs) including MET, Axl, MERTK, VEGFR family, PDGFR family, KIT, FLT3, Trk family, RET, DDR2 and selected Eph family members. Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. Nivolumab is a human IgG monoclonal antibody that binds to the programmed cell death-1(PD-1) receptor and blocks its interaction with programmed cell death ligand-1 (PD-L1) and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response including anti-tumor immune response. Combining an immunotherapeutic PD-L1 checkpoint inhibitor with an agent that has both immune modulatory and antitumor properties could enhance the antitumor efficacy observed with either agent alone.
  The study will being with a lead-in dose escalation evaluation of two dose levels of each investigational agent in combination with nivolumab. Following completion of the lead-in dose escalation, enrollment into the Phase 2 study will proceed.

Eligibility: Inclusion Criteria:
  -  Diagnosis of non-small cell lung cancer.
  -  Prior treatment with platinum based doublet and checkpoint inhibitor
  -  Adequate bone marrow and organ function
  Exclusion Criteria:
  -  Uncontrolled tumor in the brain
  -  Unacceptable toxicity with prior checkpoint inhibitor
  -  Impaired heart function

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Dynamic Changes of Circulating Tumor DNA in Surgical Lung Cancer Patients

Summary: Previous study showed circulating tumor DNA levels reflect the total systemic tumor burden. Circulating tumor DNA levels should decrease after complete surgery and could be increase as tumor recurrence. Few study investigated the half time of circulating tumor DNA in lung cancer patients that no criterion has been established of how to use it for surveillance.

Detailed description: For adenocarcinoma patients who received surgery, multiple time of plasma will be collected before or after surgery. A series of mutations will be detected in plasma before surgery based on next generation sequencing. The positive mutation will be traced after surgery and in follow up.

Eligibility: Inclusion Criteria:
  -  Suspected lung cancer before surgery
  -  No malignant tumor history within the past 5 years
  -  The pulmonary nodule is not pure ground glass opacity
  -  Patients must have given written informed consent
  Exclusion Criteria:
  -  Multiple primary lung cancer
  -  R1,R2 resection
  -  Histology confirmed not non-small cell lung cancer
  -  Unqualified blood samples

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Pulmonary Rehabilitation in Advanced Non-small Cell Lung Cancer Patients

Summary: Lung cancer (LC) is usually diagnosed in advanced stages and continues to be the leading cause of cancer related deaths worldwide. Cancer cachexia are frequent among patients with LC affecting up to 80% of patients with advanced stage disease, and it has been related with higher risk of complications, length of hospital stay, and worst overall survival. During cancer cachexia, both muscle and fat mass can be wasted, however, the loss of muscle mass has been associated to higher treatment related toxicity, loss of functional status, shorter progression free survival and overall survival in different types of cancer under various treatments. Hence, preservation of muscle mass and function should be an important focus of the multidisciplinary treatment of patients with LC.
  Pulmonary rehabilitation (PR) has been known to improve pulmonary function, reduce fatigue and improve exercise tolerance in patients with LC undergoing curative surgery. However, few studies have focused on the efficacy of PR on patients with advanced cancer undergoing palliative care with chemotherapy or targeted therapies.

Detailed description: The main objective of this study is to determine the effects of a pulmonary rehabilitation program on the pulmonary function and muscle mass. Moreover, the effects on exercise tolerance, inflammatory response, quality of live and overall survival will be explored.
  Patients will be randomized into intervention group (IG) or control group (CG). Patients in the IG will be scheduled to receive 12 sessions of PR over a period of 4-6 weeks (2-3 session/week). CG will receive information and recommendations on physical activity. Both groups will receive nutritional assessment and intervention as needed.

Eligibility: Inclusion Criteria:
  -  Confirmed diagnosis of advanced non-small-cell lung cancer
  -  Good performance status (ECOG 0-1)
  -  Life expectancy >12 weeks
  -  Eligible to receive treatment with chemotherapy or tyrosinkinase inhibitors
  -  Recent electrocardiogram without evidence of arrythmia
  Exclusion Criteria:
  -  Symptomatic brain metastasis
  -  Uncontrolled pain (Visual Analog Scale >5)
  -  Uncontrolled hypertension (>140/100mmHg)
  -  Practice of regular moderate to intense physical activity at least 3 day/week
  -  Not residents of Mexico City or unable to attend to therapy sessions

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Kentucky LEADS Collaborative: Lung Cancer Survivorship Care Program

Summary: The objective of the Kentucky LEADS Lung Cancer Survivorship Care Program is to develop, administer and evaluate the impact of a comprehensive psychosocial survivorship care program for individuals diagnosed with lung cancer and their caregivers to improve lung cancer survivorship and delivery of high-quality lung cancer care. The investigators hypothesize that the Kentucky LEADS Lung Cancer Survivorship Care Program will demonstrate improved quality of life, better symptom control, increased tobacco treatment, and reduced distress among lung cancer survivors and their caregivers.

Detailed description: The study design is a single-arm clinical trial, or a prospective cohort design, where a longitudinal series of data will be collected from participants. Participants will be consented and asked to complete a baseline questionnaire (PRE) which includes topics measuring quality of life, distress, symptom management, social support, healthy behaviors, demographics and health history. Two similar questionnaires will be administered after exposure to the Survivorship Care Program (POST and FOL). In addition, the consent form requests permission from survivors to collect clinical data from medical records and the Kentucky Cancer Registry regarding diagnosis and treatment for lung cancer. The study will enroll 300 participants, with an estimate of approximately 30 participants enrolled at each site. However, if a participating site enrolls 30 participants and the overall study accrual has not yet been met, the study PI may allow that respective participating site to continue to enroll participants. Study accrual is competitive across participating sites until the overall study accrual has been met.

Eligibility: Inclusion Criteria:
  -  Individuals who have been diagnosed with lung cancer (survivor) or
  -  Caregiver of a participating lung cancer survivor
  -  Ability to read and write in English
  Exclusion Criteria:
  -  Individuals with significant psychiatric disturbance that requires a higher level of care
  -  Individuals with substance abuse/dependence problem that require a higher level of care
  -  Incarcerate individuals or individuals detained within the legal system

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: A Study of TRK-950 in Patients With Advanced Solid Tumors

Summary: 1. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of TRK-950 as single agent
  2. To establish the dose of TRK-950 recommended for future phase 2 studies

Detailed description: This study is a first-in-human study of TRK-950 in patients with advanced solid tumors and is primarily designed to determine the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of TRK-950 administered via intravenous (IV) infusion once weekly for 3 weeks every 28 days.

Eligibility: Inclusion Criteria:
  -  Patients with histologically confirmed locally advanced or metastatic solid carcinomas
  -  Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy or not amendable to a curative treatment
  -  Measurable disease per RECIST 1.1 (primary or metastases)
  Exclusion Criteria:
  -  New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
  -  Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
  -  Pregnant or nursing women
  -  Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within four weeks prior to study entry
  -  Unwillingness or inability to comply with procedures required in this protocol
  -  Known active infection with HIV, hepatitis B, hepatitis C
  -  Symptomatic brain metastases
  -  Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
  -  Patients who are currently receiving any other investigational agent

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: TRK-820 Study in Subjects on Hemodialysis With or Without Uremic Pruritus

Summary: This study is a 2-part study.
  Part A is a single-dose, open-label study design to determine the PK, safety and tolerability of 5 μg TRK-820 oral administration in subjects with end-stage renal disease (ESRD) who require hemodialysis.
  Part B is a multiple dose, open-label study design to determine the PK, PD, safety and tolerability of multiple doses in subjects with ESRD who require hemodialysis with refractory uremic pruritus (UP). Each subject will receive 3 doses of TRK-820 (2.5, 5 and 10 μg).


Eligibility: Inclusion Criteria:
  -  Adult non-smoking male and female subjects (≥ 18 years of age) who have ESRD requiring hemodialysis, at least 3 times a week.
  -  Subjects has a clinical diagnosis of UP, which is uncontrolled by current medications or treatments.(Part B only)
  Exclusion Criteria:
  -  Subject has a known hypersensitivity to opioids or the ingredients of the study medication.
  -  Subject has pruritus other than related to ESRD (i.e., UP).(Part B only)

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Individualizing Disease Prevention for Middle-Aged Adults

Summary: The primary objective of this study is to help patients compare the benefits of various preventive care services, based on their individual risk factors (such as smoking status, obesity, high blood pressure, high cholesterol, etc.). Tailored decision aids will be provided to each participant during primary care appointments to facilitate discussion between the participant and his/her provider regarding prioritizing preventive service recommendations.


Eligibility: Inclusion Criteria:
  -  Scheduled for an appointment with primary care provider during study period
  -  Two or more of the following risk factors:
  -  Tobacco use
  -  Overweight/obese
  -  Hypertension
  -  Hyperlipidemia
  -  Diabetes
  -  Alcohol Misuse
  -  Depression
  -  History of Sexually Transmitted Infection
  -  Being overdue for the following screenings: Colorectal, cervical, breast, lung
  Exclusion Criteria:
  - Severely limited life expectancy (cancer, congestive heart failure, chronic obstructive pulmonary disease, end stage renal disease)

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Expanded Access to Provide Larotrectinib (LOXO-101) for the Treatment of Cancers With a NTRK Gene Fusion

Summary: Larotrectinib (LOXO-101) expanded access is for patients with cancer with a NTRK1, NTRK2, or NTRK3 gene fusion who are ineligible for an ongoing larotrectinib (LOXO-101) clinical trial or have other considerations that prevent access to larotrectinib (LOXO-101) through an existing clinical trial. Expanded access is intended to treat individual patients with different types of cancers with a NTRK gene fusion.


Eligibility: Inclusion Criteria:
  -  Diagnosis of cancer with a NTRK1, NTRK2, or NTRK3 gene fusion
  -  Are unable to participate in an ongoing larotrectinib (LOXO-101) clinical trial
  -  Willing and able to provide written, signed informed consent
  -  Medically suitable for treatment with larotrectinib (LOXO-101)
  Exclusion Criteria:
  - Currently enrolled in an ongoing clinical study of larotrectinib (LOXO-101) or another TRK inhibitor

Relevance to patient case: possibly relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: A Study of Merestinib (LY2801653) in Japanese Participants With Advanced or Metastatic Cancer

Summary: The main purpose of this study is to evaluate tolerability of merestinib monotherapy or in combination with other anti-cancer agents in Japanese participants with advanced and/or metastatic cancer.


Eligibility: Inclusion Criteria:
  -  Part A: Histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic (solid tumors or non-Hodgkin's lymphoma).
  -  Part B: Biliary tract carcinoma that is unresectable, recurrent, or metastatic. The participant must not have received prior systemic front-line therapy for metastatic or resectable disease.
  -  Part A: Measurable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Cheson Criteria.
  -  Part B: Measurable disease as defined by RECIST v1.1.
  -  Adequate organ function including hematologic, hepatic and renal.
  -  Eastern Cooperative Oncology Group (ECOG) scale of 0 or 1.
  -  Are able to swallow tablets.
  -  For participants in Part B, a tumor tissue sample is mandatory for biomarker analysis.
  -  Males must agree to use medically approved barrier contraceptive precautions during the study and for 3 months following the last dose of study drug.
  -  Females with childbearing potential: Must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug, must have had a negative serum or urine pregnancy test ≤7 days before the first dose of study drug.
  -  A breastfeeding woman must not be breastfeeding. If a female who stops breastfeeding enters the study, breastfeeding must cease from the day of the first study drug administration until at least 3 months after the last administration.
  Exclusion Criteria:
  -  Have serious pre-existing medical conditions.
  -  Have a chronic underlying infection.
  -  Have symptomatic central nervous system malignancy or metastasis.
  -  Have an active fungal, bacterial, and/or known viral infection.
  -  Part B: Have mixed hepatocellular biliary tract carcinoma histology.
  -  Have liver cirrhosis with a Child-Pugh stage of B or higher, or have received a liver transplant.
  -  Have a history of congestive heart failure with New York Heart Association (NYHA) class greater than 2, unstable angina, or have recent history of myocardial infarction, transient ischemic attacks, stroke, or arterial or venous vascular disease.
  -  Have a corrected QT interval >470 milliseconds as calculated be the Fredericia equation.
  -  Have a second primary malignancy that, in the judgment of the investigator, and sponsor may affect the interpretation of results.
  -  Have any evidence of clinically active interstitial lung disease (ILD).

Relevance to patient case: not relevant