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

Clinical trial: Studying Fibroblast Activity in Patients With Localized Pancreatic Cancer Undergoing Surgery

Summary: RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This research study is assessing fibroblast activity in patients with localized pancreatic cancer undergoing surgery.

Detailed description: OBJECTIVES:
  Primary
  -  To assess the degree of fibroblast activation protein (FAP) enzymatic activity at the tumor site in patients with localized pancreatic cancer.
  Secondary
  -  To explore correlations between tumor stromal FAP enzymatic activity and stromal α_2-antiplasmin levels.
  -  To explore correlations between tumor FAP enzymatic activity and plasma dipeptidyl peptidase and plasma α_2-antiplasmin converting enzyme activity as potential surrogates.
  OUTLINE: Patients undergo fine-needle aspiration of tumor or suspected mass at baseline. Tumor samples are analyzed by IHC for fibroblast activation protein (FAP) expression, immunocapture assay for ex vivo FAP enzymatic activity, and western analysis for FAP concentrations. Blood samples are collected weekly and analyzed for dipeptidyl peptidase activity by ELISA and α_2-antiplasmin converting enzyme.

Eligibility: DISEASE CHARACTERISTICS:
  -  Biopsy-proven adenocarcinoma of the pancreas or pancreatic mass suspicious for pancreatic cancer
  -  Localized disease
  -  Scheduled to undergo a resection or exploration of their pancreatic tumor
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: Nurse-Provided Care or Standard Care in Treating Patients With Pancreatic Cancer

Summary: RATIONALE: Meeting with a nurse to assess symptoms and quality of life may be more effective than standard care in treating patients with pancreatic cancer.
  PURPOSE: This clinical trial is studying nurse-provided care to see how well it works compared with standard care in treating patients with pancreatic cancer.

Detailed description: OBJECTIVES:
  -  To test the effects of an advanced practice nurse (APN) standardized nursing-intervention protocol (SNIP) model vs usual care on overall quality of life (QOL) and psychological distress from initial treatment to 6 months post diagnosis for patients with pancreatic cancer.
  -  To compare symptom control in these patients.
  -  To compare geriatric assessment outcomes in these patients.
  -  To test the effects of the SNIP intervention as compared to the usual care group on resource use by these patients.
  -  To test the effects of SNIP on patients' and clinicians' satisfaction with care.
  -  To describe the effects of SNIP on patients' management of transitions from one phase of chronic illness to another.
  -  To identify subgroups of these patients who benefit most from the SNIP in relation to sociodemographic characteristics, disease/treatment factors, and geriatric assessment predictors.
  -  To obtain feedback from clinicians regarding interpretation of findings and application to the routine care of pancreatic cancer patients.
  OUTLINE: Patients are sequentially enrolled to 1 of 2 groups. Group 1 is enrolled during months 4-21 and group 2 during months 25-54.
  -  Group 1 (usual care): Patient questionnaires are administered at baseline and at 3 and 6 months. The clinicians' satisfaction with care is also evaluated.
  -  Group 2 (advanced practice nurse [APN] intervention): Patients are accrued by an APN. Patients meet with the APN periodically to assess their physical well-being including ambulatory care needed, care of physical symptoms (i.e., pain, fatigue, nausea and vomiting), and psychological well-being. Questionnaires are administered at baseline and at 3 and 6 months.
  In both groups, questionnaires include the FACT-Hep, Memorial Symptom Assessment Scale, Psychological Distress Thermometer, Comprehensive Geriatric Assessment, and Patient Satisfaction with Intervention. Clinicians also complete questionnaires. Patients' medical charts are also reviewed.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of pancreatic cancer (all stages)
  PATIENT CHARACTERISTICS:
  -  Admitted to City of Hope National Medical Center
  -  Resides within a 30-mile radius of the medical center
  -  No prior cancer
  PRIOR CONCURRENT THERAPY:
  -  No prior therapy

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

Clinical trial: Gemcitabine (GFF) in Patients With Pancreatic Cancer

Summary: The purpose of this study is to examine the efficacy and safety of the drug combination GFF in patients with advanced pancreatic cancer (APC).

Detailed description: This open-label, multi center phase II study was conducted to investigate the efficacy and safety of the combination of 5-Fluorouracil (5-FU)/folinic acid (FA) plus gemcitabine (GFF) in patients (pts) with advanced pancreatic cancer (APC). We consequently started this study after completing the phase I trial accomplished by our CONKO- study group.

Eligibility: Inclusion Criteria:
  -  histological proved pancreatic cancer
  -  inoperable disease
  -  informed consent
  -  adequate bone marrow reserve
  Exclusion Criteria:
  -  under 18 years
  -  brain metastasis
  -  lactating woman
  -  life expectancy under 3 months

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

Clinical trial: Parenteral Nutrition Support for Patients With Pancreatic Cancer

Summary: The purpose of this study is to determine whether the additional nutrition support is improving the nutritional status of patients suffering cancer caxechia or not.

Detailed description: To examine the impact of additional parenteral nutrition (APN) we prospective evaluated 32 pts suffering APC and progressive cachexia. This assay is based on a bioelectrical impedance analysis (BIA) as a proven tool for nutritional investigation in patients with chronic disease. Phase angle, determined by BIA, has been found to be a prognostic indicator in several chronic and malignant conditions, such as HIV, liver cirrhosis, chronic obstructive pulmonary disease lung cancer and pancreatic cancer.

Eligibility: Inclusion Criteria:
  -  histological proved pancreatic cancer
  -  progressive cancer cachexia
  -  refractive to enteral supplementation
  -  informed consent
  Exclusion Criteria:
  -  prefinal status
  -  septic 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: Trial of Erlotinib, Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer

Summary: The purpose of this study is to determine the response rate of gemcitabine, cisplatin and erlotinib in metastatic pancreatic cancer.


Eligibility: Inclusion Criteria:
  -  Age older than 18
  -  Younger than 75
  -  ECOG performance status 0 or 1
  -  Histologically confirmed adenocarcinoma of the pancreas
  -  Metastatic pancreatic cancer
  -  No prior chemotherapy for metastatic pancreatic cancer
  -  A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT)
  Exclusion Criteria:
  -  A patient with no measurable disease
  -  A patient who received previous palliative chemotherapy for pancreatic cancer
  -  A patient with locally advanced pancreatic cancer
  -  A patient who received adjuvant chemotherapy for pancreatic cancer within 1 year
  -  A patient with previous active or passive immunotherapy
  -  A pregnant or lactating patient

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

Clinical trial: Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients

Summary: The purpose of this study is to determine whether simvastatin is effective in the treatment of advanced pancreatic cancer patients.

Detailed description: Randomized double-blinded, placebo-controlled phase II trial of simvastatin and gemcitabine in advanced pancreatic cancer patients.

Eligibility: Inclusion Criteria:
  1. Age > 18 years
  2. Histologically or cytologically confirmed, metastatic or unresectable pancreatic adenocarcinoma (if repeated biopsy (>3) fails or if biopsy is not feasible, the inclusion of the patient will be determined by the central PI)
  3. ECOG performance status of 0~2
  4. no radiotherapy within 1 month of the study entry
  5. measurable or evaluable lesion according to RECIST criteria
  6. no prior history of chemotherapy for pancreatic cancer (gemcitabine-based adjuvant chemotherapy ≥ 12 months from the study entry will be allowed)
  7. adequate marrow, hepatic, renal and cardiac functions (absolute neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 75 x 109/L, serum creatinine ≤ 1.5 x ULN), serum aspartate aminotransferase/alanine aminotransferase ≤ 5 x ULN or ≤ 10 x ULN if liver abnormalities are due to underlying malignancy; total bilirubin ≤ 2.0 x ULN
  8. written informed consent must be provided
  Exclusion Criteria:
  1. severe co-morbid illness and/or active infections
  2. pregnant or lactating women
  3. active CNS metastases not controllable with radiotherapy or corticosteroids A.patients with symptoms suggestive of CNS metastases must undergo radiologic evaluation to rule out metastases B.patients with known, asymptomatic CNS lesions are permitted
  4. known history of hypersensitivity to study drugs
  5. patients who are currently on statin therapy or has taken statin as lipid lowering agents within 1 year of the study entry

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

Clinical trial: Cisplatin, Capecitabine, Gemcitabine and Epirubicin or Docetaxel for Patients With Stage III or IV Pancreatic Cancer

Summary: RATIONALE: Drugs used in chemotherapy, such as cisplatin, capecitabine, gemcitabine hydrochloride, epirubicin hydrochloride, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether cisplatin, capecitabine, and gemcitabine hydrochloride are more effective when given together with epirubicin hydrochloride or docetaxel in treating patients with advanced or metastatic pancreatic cancer.
  PURPOSE: This randomized phase II trial is studying the side effects of giving cisplatin, capecitabine, and gemcitabine hydrochloride together with epirubicin hydrochloride compared with giving cisplatin, capecitabine, and gemcitabine hydrochloride together with docetaxel and to see how well it works in treating patients with stage III or stage IV pancreatic cancer.

Detailed description: OBJECTIVES:
  -  Assess 6-months progression-free survival of patients with stage III or IV adenocarcinoma of the pancreas treated with cisplatin, capecitabine, gemcitabine hydrochloride (PXG) and epirubicin hydrochloride vs PXG and docetaxel.
  -  Evaluate the activity and toxicity of these regimens in these patients.
  OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 arms.
  -  Arm I (PEXG): Patients receive cisplatin, gemcitabine hydrochloride, and docetaxel on days 1 and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  -  Arm II (PGDX): Patients receive cisplatin, gemcitabine hydrochloride, and epirubicin hydrochloride on days 1and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  Patients may then undergo surgery if the tumor becomes resectable.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the pancreas
  -  Stage III or IV disease
  -  Measurable disease
  -  No symptomatic brain metastases
  PATIENT CHARACTERISTICS:
  -  Karnofsky performance status 60-100%
  -  Adequate bone marrow, liver, and kidney function
  -  Not pregnant or nursing
  -  No other malignancies within the past 5 years except surgically treated carcinoma in situ of the cervix, and basal or squamous cell carcinoma of the skin
  -  No multiple severe diseases that can compromise study safety, including any of the following:
  -  Cardiac failure
  -  Myocardial infarction within the past 4 months
  -  Cardiac arrhythmia
  -  History of psychiatric disabilities
  PRIOR CONCURRENT THERAPY:
  -  No prior chemotherapy or radiotherapy for pancreatic cancer
  -  No other concurrent experimental drugs

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

Clinical trial: Using Video Images to Improve Advance Care Planning in Patients With Cancer

Summary: The purpose of this study is to study whether preferences for the goals of care for 80 subjects with end-stage cancer are altered after viewing a video outlining the goals of care compared to their initial preferences after hearing a verbal description of the goals of care alone.

Detailed description: The purpose of this study is to study whether preferences for the goals of care for 80 subjects with end-stage cancer are altered after viewing a video outlining the goals of care compared to their initial preferences after hearing a verbal description of the goals of care alone. Subjects will choose among three goals of care, life prolonging care, basic medical care, and comfort care.

Eligibility: Inclusion Criteria:
  1. Terminal, progressive cancer with poor prognosis whose treatment intent is palliative, based on the following definition:
  -  All patients with brain cancer, liver cancer, inoperable non-small cell lung carcinoma, pancreatic cancer, or gallbladder cancer; OR
  -  Patients with the following cancers: metastatic colon cancer or stage III or IV non-small cell lung cancer; OR
  -  Patients with the following cancers, if first-line therapy has failed and limited response is expected to second-line therapy: breast cancer, colorectal cancer, head and neck cancer, stomach cancer, esophageal cancer, melanoma, leukemia, ovarian cancer, prostate cancer, renal cancer, sarcoma, lung cancer, myeloma, or lymphoma.
  -  The terms terminal, progressive, poor prognosis, palliative intent and limited response will be judged by the patient's oncologist (and not by the RSA or consenting professional).
  2. Return patient visit (defined as a patient known to the oncologist from previous assessments and treatments, where the working and personal relationship has been established and not a new patient to the clinic).
  3. English speaking. Only English-speaking patients will be included in our present study since English is the validated language of our study tools.
  4. Given the sensitive nature of the study, clinicians will decide whether the patient is a potentially appropriate subject based on their knowledge of the patient.
  5. Able to provide informed consent.
  6. Age greater than or equal to 21.
  Exclusion Criteria:
  1. MMSE < 25.
  2. Psychological state not appropriate for end-of-life discussion as determined by the treating clinician.

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 Blood Samples From Patients With Malignant Melanoma, Metastatic Breast Cancer, Advanced Lung Cancer, Pancreatic Cancer, or Colorectal Cancer. ICORG 07-12

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in peptides and proteins and identify biomarkers related to cancer.
  PURPOSE: This research study is looking at blood samples from patients with malignant melanoma, metastatic breast cancer, advanced lung cancer, pancreatic cancer, or colorectal cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To assess which potential peptide and protein markers produced by human melanoma, lung, breast, pancreatic, and colorectal cell lines may be detectable in serum of patients from these five disease groups.
  Secondary
  -  To conduct further extensive investigation with respect to identification of the protein/peptide involved, determination of specificity for each cancer, and development of more sensitive assays to look for such markers in a wider population of patients, including those undergoing therapy.
  OUTLINE: This is a multicenter study.
  Blood samples are collected before surgical intervention or treatment to assess peptide and protein markers.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of 1 of the following advanced metastatic malignancies:
  -  Malignant melanoma
  -  Lung cancer
  -  Breast cancer
  -  Pancreatic carcinoma
  -  Colorectal cancer
  -  Advanced and/or metastatic disease
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

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

Clinical trial: Tailored Case Management for Diabetes and Hypertension

Summary: Diabetes and hypertension co-exist in approximately 10 million people in the USA and constitute severe risk factors for the development of such complications as heart and kidney disease. The investigators propose a randomized controlled trial in patients of community primary care practices to study a tailored telephone-administered behavioral intervention to improve control of blood pressure and blood sugar in patients with both hypertension and diabetes. The investigators hypothesize that 20% more patients talking to a nurse every other month about ways to improve blood pressure and blood sugar control will bring their blood pressure under control when compared to patients who talk with the nurse only about general health issues. If successful in improving control of these diseases this intervention can easily be adopted in other community primary care practices to lessen the burden of diabetes and hypertension in the USA.


Eligibility: Inclusion Criteria:
  -  Enrolled and receiving primary care at one of 9 participating clinics in North Carolina
  -  Diagnosis of diabetes as determined by billing data
  -  Taking medication for diabetes
  -  Diagnosis of hypertension as determined by billing data
  -  Taking medication for hypertension
  -  Most recent (within one year) Hemoglobin A1c >= 7.5%
  Exclusion Criteria:
  -  Active psychosis
  -  Hospitalization for stroke, myocardial infarction (MI), or coronary artery revascularization in the past 6 months
  -  Type I diabetes
  -  Does not speak English
  -  No access to a telephone
  -  Institution-dwelling or receiving comprehensive professional home health care
  -  Hearing or speech inadequate for long interactive phone conversations
  -  Terminal illness or active treatment for cancer
  -  Cognitive impairment too severe to understand instructions

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

Clinical trial: Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer

Summary: This is a phase 1b study to evaluate the combination of gemcitabine and Tarceva (erlotinib) and nab-paclitaxel in patients with advanced pancreatic cancer.

Detailed description: This is a single-arm, phase 1b study to determine the maximum tolerated dose (MTD) of the combination of erlotinib (daily), gemcitabine (weekly), nab-paclitaxel (weekly) in patients with advanced pancreatic cancer.

Eligibility: Inclusion Criteria:
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
  -  Predicted life expectancy of >= 12 weeks
  -  Previous surgery
  -  Histologically or cytologically confirmed, measurable, locally advanced, unresectable or metastatic pancreatic adenocarcinoma
  -  No prior therapy for pancreatic cancer
  -  Adequate organ and marrow function
  -  Absolute neutrophil count >= 1.5 x 10^9/L
  -  Platelets >= 100 x 10^9/L
  -  Total bilirubin <= institutional upper limits of normal
  -  AST (SGOT)/ALT(SGPT) <= 2 x institutional upper limits of normal
  -  Serum creatinine <= 1.5 x upper limits of normal
  -  Negative pregnancy test
  -  Informed consent
  -  Patient must agree not to smoke while on study
  Exclusion Criteria:
  -  Significant history of cardiac disease unless the disease is well controlled
  -  Active or uncontrolled infections or serious illness or medical conditions that could interfere with the patient's ongoing participation in study
  -  History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent
  -  History of smoking within the previous 14 days before enrollment or positive cotinine test at baseline
  -  Pregnant or breast-feeding females
  -  Symptomatic brain metastases that are not stable, that require steroids, that are potentially life-threatening, or that have required radiation within the last 14 days
  -  History of allergic reactions attributed to compounds of similar chemical or biological composition to the study drugs

Relevance to patient case: not relevant