araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Effects of Chardonnay Seed Flour on Vascular Health

Summary: This is a randomized, double-blinded trial (Chardonnay seed flour vs. placebo - in pill form) with the purpose to test the impact of a four-month supplementation with Chardonnay Seed Flour (CSF) on endothelial function. Chardonnay flour is made from wine grape skins and seeds. We will examine the effect of CSF on parameters such as endothelial function (via EndoPAT testing), plasma lipid levels, glucose tolerance, insulin resistance, inflammatory markers, oxidative stress surrogates, endothelial progenitor cells (EPCs) as well as the makeup of and impact on the gut microbiome (via stool samples).


Eligibility: Inclusion Criteria:
  1. Age >= 18 years old
  2. Demonstrated endothelial dysfunction (EndoPAT score <= 2) at time of screening.
  Exclusion criteria:
  1. Age below 18 or above 80
  2. Endothelial function greater than 2.0 at baseline
  3. Hypertension (at screening): any patient with systolic blood pressure (SBP >=170 mmHg or diastolic blood pressure >= 110 mmHg, or hypotension (SBP < 100 mmHg
  4. Abnormal liver function tests
  5. Uncontrolled Diabetes Mellitus or the use of metformin for Diabetes Mellitus
  6. Difficulty swallowing capsules
  7. Gastrointestinal disease manifesting with symptoms of malabsorption such as celiac disease or Crohn's disease
  8. Non-English speakers
  9. Vulnerable populations unable to consent such as prisoners or dependents
  10. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the CSF including, but not limited to, any of the following:
  1. History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bowel resection
  2. Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase
  3. Evidence of hepatic disease as determined by a history of hepatic encephalopathy, a history of cirrhosis, esophageal varices, or a history of portocaval shunt.
  11. History of hypersensitivity to any of the study supplement or suspected contraindications to the study supplement.
  12. History of noncompliance to medical regimens or unwillingness to comply with the study protocol

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Pancreatic Stump Closure After Distal Pancreatic Resection

Summary: The aim of this study is to investigate whether finnish binding pancreatico-jejunal anastomosis is feasible and prevents the risk for post operative pancreatic fistula after distal pancreeatectomy.


Eligibility: Inclusion Criteria:
  -  patiens which the distal pancreatic resektions
  -  the type of resections that is techically possible with finnish binding panceatico-jejunal anastomosis
  Exclusion Criteria:
  -  if the pancreas is not suitable for this kind of anastomosis

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: The Impact of a Physical Activity Program on Biomarkers of Aging During Chemotherapy for Breast Cancer

Summary: This study will look at whether or not participating in a physical activity intervention during chemotherapy for breast cancer can prevent a marker of aging called p16 from having a large increase after chemotherapy.

Detailed description: Our research team has determined that p16INK4a - a biomarker of aging -- increases dramatically during chemotherapy and that p16 levels among patients of similar age are lower among those who exercise. We hypothesize that engagement in physical activity during chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy. To test this hypothesis, we propose to enroll 48 patients age 21-59 with a Stage I-III breast cancer diagnosis who are about to start adjuvant or neoadjuvant chemotherapy in a physical activity intervention program. Our primary objective is to compare the change in p16 from baseline to end of chemotherapy for participants in this study (who are engaged in a physical activity intervention) to the mean change in p16 seen in a previous study of similar patients who did not participate in a physical activity intervention. As secondary objectives, we propose to evaluate (1) changes in treatment-related toxicity, physical function, fatigue, and quality of life between baseline, end of chemotherapy and 6 months post-chemotherapy, (2) the association of changes in p16 levels with changes in measures of treatment-related toxicity, physical function, fatigue, and quality of life, and (3) the association of changes in physical activity levels with changes in measures of treatment-related toxicity, physical function, fatigue, and quality of life.

Eligibility: Inclusion Criteria:
  -  21 to 59 years of age, female (A similar trial LCCC 1226 explores physical activity in women 60 years and older and is now in progress.
  -  Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)
  -  Scheduled to begin an appropriate adjuvant or neo-adjuvant chemotherapy regimen as defined by NCCN guidelines (www.nccn.org). Patients receiving anti-HER-2 therapy are eligible but the intervention will only be tested during the chemotherapy portion of the regimen.
  -  English speaking
  -  IRB approved, signed written informed consent
  -  Approval from their treating physician to engage in moderate-intensity physical activity
  -  Patient-assessed ability to walk and engage in moderate physical activity
  -  Willing and able to meet all study requirements.
  Exclusion Criteria:
  -  One or more significant medical conditions that in the physician's judgment preclude participation in the walking or strength training intervention.
  -  Unable to walk or engage in moderate-intensity physical activity.

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Quality of Life After Surgery for Pancreatic Carcinoma

Summary: Pancreatic cancer has a high mortality rate. Patients with an intended curative resection show a median survival of 17-23 months. Therefore, quality of life is very important in this patient group. In this study, the effect of pancreatic surgery on quality of life is measured.


Eligibility: Inclusion Criteria:
  -  patients with a suspected pancreatic malignancy
  -  eligible for surgery with curative intent
  -  being able to complete questionnaires in Dutch
  -  age >=18 years
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)

Summary: The purpose of this signal seeking study is to determine whether treatment with LEE011 demonstrates sufficient efficacy in CDK4/6 pathway activated solid tumors and/or hematologic malignancies to warrant further study.


Eligibility: Inclusion Criteria:
  -  Patient has a confirmed diagnosis of a select solid tumor (except breast cancer (however, triple negative will be included), liposarcoma, CRPC, melanoma and teratoma) or hematological malignancy (except mantle cell lymphoma).
  -  Patient must have been pre-identified as having a tumor with CDK4 amplification or mutation, CDK6 amplification or mutation, Cyclin D1 (CCND1) amplification, Cyclin D3 (CCND3) amplification, or p16 (CDKN2A) mutation
  -  Patient has received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.
  -  Patient has progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines.
  -  Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  Exclusion Criteria:
  -  Patients has received prior treatment with LEE011.
  -  Patient has clinically significant resting bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval > 109 msec, or QTcF > 450 msec.
  -  Patients has primary CNS tumor or CNS tumor involvement
  -  Patient has received chemotherapy or anticancer therapy ≤ 4 weeks prior to starting study drug

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Comparison Between Base and Cover Slide From Endoscopic Ultrasound Guided Fine Needle Aspiration for Pancreatic Cancer

Summary: The purpose of this study is to determine whether there is a difference of diagnostic accuracy between cover slides and base slides from EUS-FNA cytopathologic sample in patients who were previously suspected of pancreatic cancer in radiologic test.

Detailed description: 1. background
  1. Pancreatic cancer is the challenging malignancy in diagnosis and treatment.
  2. Recently, EUS-FNA has played a important role in diagnosing pancreatic cancer.
  3. Samples from EUS-FNA are sent to following three types of preparations.
  -  cytologic smear (by pull apart method)
  -  cell block
  -  histologic biopsy
  4. In cytologic smear method, endoscopists tend to send as many as slides, while pathologists want minimal slides if they warrant diagnostic accuracy.
  5. Therefore we are going to find a point of contact between high diagnostic yield and minimal overloading of pathologist.
  2. Method
  1. We are going to enrolled the patients who were suspected of pancreatic cancer in previous radiologic test.
  2. One identical and skilled endoscopist performs EUS-FNA with multiple punctures.
  3. We get total 8 pairs of slides (= 8 covers + 8 bases).
  4. All the cover slides are collected to the bottle-A, all the base slide to the bottle-B.
  5. One identical and skilled pathologist inspects these slide in blind method. (She cannot show the label of bottle so that she does not know what bottle is A or B.)
  6. She record the positive or negative in each bottle. (If there is only one slide is positive in malignant cell, the bottle is positive.)
  7. In these manner, we collect the all subjects' cytopathologic results as a pair of outcome. All the possible combinations are following four examples:
  -  (cover/base) = (positive/positive) = (+/+)
  -  (cover/base) = (positive/negative) = (+/-)
  -  (cover/base) = (negative/positive) = (-/+)
  -  (cover/base) = (negative/negative) = (-/-)
  8. Then we are going to take a two-sided non-inferiority test of proportion using McNemar's test.

Eligibility: Inclusion Criteria:
  -  patients who were suspected of pancreatic cancer in previous radiologic test such as computed tomography, magnetic resonance imaging or Positron Emission Tomography.
  Exclusion Criteria:
  -  failed smear due to inexperienced assistant
  -  loss of slide
  -  patients who were diagnosed with other lesion far from pancreatic cancer in prospective confirmative tests.
  -  patients who refuse to participate in this study
  -  report of other pathologist who are not a previously-assigned pathologist

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: The Clinical Study of Acute Pancreatitis Treated by TongFuSan

Summary: The purpose of this study is to determine whether TongFuSan is effective in the treatment of acute pancreatitis with gastrointestinal dysfunction.

Detailed description: -  Patient who is diagnosed with acute pancreatitis(AP) should be included.
  -  Patients will be divided into two groups as random number table: control group(A) and experimental group(B).
  -  Group A will be given Mosapride po,and group B will be given TongFusan except for basic treatments of AP.
  -  Same investigator will write the case report form.
  -  Investigator will collect the patients' blood in three points: on admission, the third day and the seventh day.
  -  Otherwise, we need write down patients' clinical manifestation,Traditional Chinese Medicine differentiation, the result of clinical tests.
  -  When the patient discharge, we will write down the treatment measures, therapeutic effect, length of stay and the costs.

Eligibility: Inclusion Criteria:
  -  clinical diagnosis of acute pancreatitis，both mild type and severe type
  Exclusion Criteria:
  -  pregnant or suckling
  -  cancer in late time
  -  patient near death

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Pancreatic Cancer Early Detection Program

Summary: Early detection testing is recommended for individuals at elevated risk for the development of Pancreatic Cancer. This Protocol will define sufficiently elevated risk as either equal to or greater than five times the general population risk, or five times the average risk (1.5%) of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk. Our inclusion criteria has a strong focus on the risk for pancreatic cancer imparted by the presence of hereditary cancer genes, as well as by family history. Enrolled subjects will undergo Endoscopic Ultrasound (EUS) alternating with Magnetic Resonance Imaging (MRI), every six to 12 months, for up to 5 years.

Detailed description: Interested individuals can be referred by physicians, or by family or friends.
  Individuals are informed that the purpose of this study is to collect outcome data following early detection testing based upon our criteria for elevated risk.
  Consent is obtained by any of the co-investigators. Consent is obtained for the primary PCEDP, and also obtained to allow for data to be used by our Cancer Program.
  We have a weekly review of all calls made and of all enrollments.
  We have a monthly meeting to review all proceeding regarding the study.
  Our IRB routinely reviews the proceedings of the study
  Our institution has a monthly Clinical research Committee meeting.

Eligibility: Inclusion Criteria: Any of the following:
  1. Known carrier of either the BRCA2 or CDKN2A mutation;
  2. Known carrier of any of the following mutations (BRCA1, MLH1, MSH2, PMS2, MSH6, EPCAM , P53, PALB2, APC, or ATM) PLUS first or second degree relative affected with pancreatic cancer;
  3. Individual with Peutz-Jeghers Syndrome;
  4. Familial Pancreatic Cancer, defined as at least two affected relatives with Pancreatic Cancer, who are first degree relatives with each other, and at least one of those affected must be first degree relative to the study subject;
  5. Both parents affected, any age:
  6. Any first degree relative diagnosed with pancreatic cancer under age 50;
  7. Chronic Pancreatitis Syndrome, defined by either PRSS1 or SPINK1 mutations AND appropriate clinical and family history
  Exclusion Criteria:
  1. Any medical condition that contraindicates endoscopy or biopsy
  2. Any medical condition that contraindicates MRI
  3. Status post partial or complete resection of the pancreas
  4. History of pancreatic cancer, either endocrine or exocrine
  5. Clinical suspicion of pancreatic cancer, or any previous radiographic or histologic diagnosis of a pre-malignant finding, including IPMN (Intraductal papillary mucinous neoplasm) and PanIN (Pancreatic intraepithelial Neoplasm).
  6. diagnosis of dementia
  7. Uncontrolled, current illness
  8. Renal insufficiency with serum creatinine greater than 2.0 mg/dl

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Digestive System

Summary: Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects. The main purpose is to identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma.

Detailed description: Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects.
  1. Main purpose
  1. To identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma.
  2. To explore the largest mechanical index and ultrasonic treatment time which patients can endure.
  2. Secondary purpose
  1. To observe tumor clinical benefit rate (CR+PR+SD).
  2. To evaluate the preliminary effect,such as time to failure(TTF), time to death(TTD)

Eligibility: Inclusion Criteria:
  -  Pathological diagnosis of liver metastases from alimentary system and pancreatic carcinoma
  -  Failed routine chemotherapy
  -  Neoplasms can be evaluated by imaging
  -  ECOG《2
  Exclusion Criteria:
  -  Have systematic chemotherapy in 2 weeks
  -  Be allergic to ultrasonic microbubbles and chemotherapeutics
  -  Uncontrolled high blood pressure, cardiovascular disease
  -  Active bleeding
  -  Have serious mental and psychological disease

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Longitudinal Pancreatic Cancer Study

Summary: To obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting longitudinal specimens from subjects diagnosed with any stage of pancreatic cancer.

Detailed description: The study objectives are described below:
  1. Obtain serum and plasma specimens longitudinally collected from approximately 140 subjects diagnosed with pancreatic cancer and are about to or are currently undergoing treatment and follow-up. Specimens will be used to evaluate CA 19-9 assays, currently under development, as an aid for monitoring recurrence or progressive disease.
  2. To store any remaining specimens for use in future cancer research and to evaluate as yet undetermined biomarkers for the development of IVDs, including additional CA 19-9 assays, for monitoring the course of disease and therapy in subjects diagnosed with pancreatic cancer.

Eligibility: Inclusion Criteria:
  -  Males and females, age≥ 18 years
  -  Histologic/pathologic confirmation of exocrine pancreatic cancer
  -  Any stage of disease: Newly diagnosed, stable, disease progression
  -  Any treatment time point: Treatment naïve, currently receiving or completed therapy for pancreatic cancer including active monitoring.
  -  Individuals with a history of malignant disease other than pancreatic cancer that was resected greater than 5 years ago and are currently in remission are eligible.
  -  Life expectancy greater than 6 months
  -  Able to understand and willing to provide informed consent
  Exclusion Criteria:
  -  Males and females, age <18 years
  -  No histologic/pathologic confirmation of exocrine pancreatic cancer
  -  Life expectancy less than 6 months
  -  Any concurrent malignancy other than basal or squamous cell skin cancers or in-situ cervical cancer.
  -  Unable to provide informed consent

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Study of Gemcitabine, Abraxane® Plus Placebo Versus Gemcitabine, Abraxane® Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma

Summary: This is a randomized, double blind, 3 arm (1:1:1) study in subjects with 1st-line metastatic pancreatic ductal adenocarcinoma.
  The purpose is to test the efficacy and safety of demcizumab, when given in combination with gemcitabine and Abraxane® compared to placebo. The administration of gemcitabine and Abraxane® is a standard treatment for patients with metastatic pancreatic ductal adenocarcinoma.


Eligibility: Inclusion Criteria:
  1. Subjects must have histologically confirmed metastatic pancreatic ductal adenocarcinoma.. Prior chemotherapy and/or radiotherapy either in the adjuvant or neoadjuvant setting or for metastatic disease is not allowed.
  2. Availability of FFPE tumor tissue (from either the primary tumor, locoregional disease or a metastatic site), either fresh core-needle-biopsied or archived (two FFPE cores preferred whenever possible). If fresh tissue is obtained, the core biopsy must be done at least 7 days prior to randomization.
  3. Age ≥21 years
  4. ECOG performance status 0 or 1 5. Measurable disease per RECIST v1.1
  5. Adequate organ and marrow function
  6. Signed Informed Consent Form
  7. For women of childbearing potential, agreement to use two effective forms of contraception
  Exclusion Criteria:
  1. Subjects with a neuroendocrine tumor of the pancreas, an acinar tumor of the pancreas or a pancreatic tumor with mixed histologies.
  2. Subjects receiving heparin, warfarin, factor Xa inhibitors or other similar anticoagulants. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.
  3. Subjects with brain metastases, leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
  4. Subjects with Grade >2 peripheral neuropathy
  5. Subjects with clinically significant ascites
  6. Malignancies other than pancreatic cancer successfully treated within 3 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, treated superficial bladder cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent
  7. Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months
  8. History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
  9. Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
  10. Pregnant women or nursing women
  11. Subjects with known HIV infection
  12. Known bleeding disorder or coagulopathy

Relevance to patient case: not relevant