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

Clinical trial: Study of Families With Melanoma

Summary: RATIONALE: A study that evaluates patients' lifestyle, skin, and blood and tissue samples may help doctors understand the risk factors for melanoma relapse.
  PURPOSE: This clinical trial is studying the risk factors for melanoma in families with melanoma.

Detailed description: OBJECTIVES:
  Primary
  -  Determine what lifestyle factors and which genes govern relapse from melanoma.
  Secondary
  -  Compare sun exposure and genes that cause melanoma in patients with melanoma vs healthy participants.
  -  Assess how unusual moles relate to sun exposure and genes that cause melanoma.
  OUTLINE: This is a multicenter, cohort study.
  Patients and healthy participants complete lifestyle questionnaires by mail and telephone. Some patients* and healthy participants undergo a skin examination to count moles and classify skin type (e.g., degree of freckling and wrinkling indicative of sun damage).
  NOTE: *Patients diagnosed with primary invasive melanoma after September 2005 do not need to consent to a skin examination.
  Patients and healthy participants also undergo blood collection for lymphocyte analysis, DNA extraction, and the measurement of minerals, vitamins, and beta carotene. Tissue samples from original diagnosis are examined by immunohistochemistry for gene expression and mutations, including CDKN2A and CDK4.
  Patients and healthy participants are followed annually.
  Peer reviewed and funded or endorsed by Cancer Research UK
  PROJECTED ACCRUAL: A total of 3,700 patients and healthy participants will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  Newly diagnosed primary invasive melanoma (patient group)
  -  Lentigo maligna malignant melanoma allowed
  -  Rare variants of melanoma allowed, including any of the following:
  -  Acral lentiginous
  -  Subungual
  -  Ear, nose, and throat
  -  Oropharyngeal
  -  Perineal
  -  Vaginal
  -  Vulval
  -  Rectal
  -  Nodal with no known primary
  -  Patients undergoing sentinel node biopsy are eligible
  -  No in situ melanoma, melanocytic intraepidermal neoplasia, or ocular melanoma
  -  Healthy participant meeting either of the following criteria (control group):
  -  Relative of a patient who was diagnosed with melanoma after September 2005
  -  Healthy volunteer who is age- and sex-matched for patients who were diagnosed with melanoma before October 2005
  PATIENT CHARACTERISTICS:
  -  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: Liprotamase Efficacy Trial in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency

Summary: This is a clinical trial which will evaluate the efficacy of Liprotamase treatment in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (PI).

Detailed description: This trial is divided into four distinct periods:
  1. Baseline Period during which each patient is taken off pancreatic enzyme medications.
  2. An Open-Label Treatment Period during which all patients will receive ALTU-135 (liprotamase).
  3. Inpatient, Double Blind Treatment Period during which half of patients will be withdrawn from treatment and will receive Placebo.
  4. Second Open-Label Treatment Period during which all patients will resume treatment with ALTU-135 (liprotamase).

Eligibility: Inclusion Criteria:
  -  Females of childbearing potential must be willing to use birth control
  -  Diagnosis of CF based upon the following criteria:
  -  two clinical features consistent with CF; and
  -  either genotype with two identifiable mutations consistent with CF, OR
  -  sweat chloride >60 mEq/L by quantitative pilocarpine iontophoresis
  -  Clinically stable with no evidence of acute upper or lower respiratory tract infection
  -  PI determined by fecal elastase <100 µg/g stool measured at screening
  -  Able to take pancreatic enzyme supplementation in the form of capsules
  -  Able to perform the testing (e.g., stool collections) and inpatient stays required for this study, as judged by the Investigator
  -  Baseline coefficient of fat absorption (CFA) less than or equal to 80%
  Exclusion Criteria:
  -  CFA >80% at Baseline
  -  Pregnancy, breastfeeding or of childbearing potential and not willing to use birth control during the study
  -  History of fibrosing colonopathy
  -  History of liver transplant, lung transplant or significant surgical resection of the bowel
  -  Any acute or chronic diarrheal illness unrelated to PI
  -  Unable to discontinue enteral tube feedings during the study
  -  Known hypersensitivity to food additives
  -  Inability to consume the diet required by the study, in the judgment of the Investigator
  -  Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening
  -  Abnormal liver function (except for patients with Gilbert Syndrome)
  -  Signs and/or symptoms of liver cirrhosis, portal hypertension or documented liver disease unrelated to CF
  -  Distal intestinal obstruction syndrome (DIOS) in the last six months prior to screening
  -  Unable to discontinue the use of pancreatic enzymes
  -  Any condition that the Investigator believes would interfere with the intent of this study or would make participation not in the best interest of the patient
  -  Patient is unlikely to complete the study, as determined by the Investigator

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 and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer

Summary: This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.

Detailed description: This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer. This research treatment will evaluate the combination of two chemotherapy agents, oxaliplatin and gemcitabine with radiation therapy. The researchers have already done studies using oxaliplatin, gemcitabine and radiation therapy together for pancreatic cancer. They want to build on the information they have from this previous research and do the research at multiple sites. They will use this study to determine how well people do who are treated with gemcitabine, oxaliplatin, and radiation therapy prior to having surgery for their pancreatic cancer. The researchers will also gather more information about what type of side effects occur with this treatment.

Eligibility: Inclusion Criteria:
  -  Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas.
  -  Patients must be deemed resectable or borderline resectable based on criteria in section 4.2 prior to registration.
  -  Patients must have an expected life expectancy of at least 12 weeks and a Zubrod performance status of < 2.
  -  Patients must have adequate organ function defined as follows: absolute neutrophil count of > 1500/mm3, platelets > 100,000/mm3, serum Cr < 1.5 mg/dl, total bilirubin < 3.0 mg/dl with relief of biliary obstruction if present (PTC tube or endobiliary stent).
  -  Patients must be free of other active systemic malignancy, ongoing infection, including HIV infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
  -  Patients must be aware of the investigational nature of the therapy and provide written informed consent.
  -  Patients must have no history of previous chemotherapy for pancreatic cancer or any abdominal radiation therapy.
  -  Patients must not have used any investigational agent in the month before enrollment into the study.
  Exclusion Criteria:
  -  Patients with neuroendocrine tumors are excluded.
  -  Patients with preexisting peripheral neuropathy > grade 2 are ineligible.
  -  Pregnant or nursing women are ineligible and patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after trial.

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

Clinical trial: Germline Mutations in Patients With Head and Neck Cancer and a Family History of Cancer

Summary: RATIONALE: Studying gene mutations in samples of DNA from patients with head and neck cancer and a family history of cancer may help doctors learn more about the development of cancer in families.
  PURPOSE: This clinical trial is studying germline mutations in patients with head and neck cancer and a family history of cancer.

Detailed description: OBJECTIVES:
  -  Measure the incidence of p16^INK4a germline mutations in patients with squamous cell carcinoma of the head and neck and a family history of cancer.
  -  Determine biologic activity of identified p16^INK4a germline mutations.
  OUTLINE: DNA specimens are collected for genetic and mutation analysis and examined by PCR and flow cytometry. The activity of cells with p16 mutations is determined by cell cycle arrest functional assay.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of squamous cell carcinoma (SCC) of the head and neck
  -  Must have ≥ 1 first-degree relative with any of the following cancers:
  -  Non-small cell lung cancer
  -  Melanoma
  -  Pancreatic cancer
  -  SCC of the head and neck
  -  Lymphoma (controls)
  PATIENT CHARACTERISTICS:
  -  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: Comparing Endoscopic Based Stent Strategy Versus Bypass Surgery in Non-resectable Periampullary Cancer

Summary: Randomized study comparing endoscopic stent insertion strategy versus double-bypass surgery in non-resectable periampullary cancer

Detailed description: Experience shows that patients with advanced periampullary cancer suffer not only from jaundice but in 25 -30% of cases also duodenal stricture with nausea, vomiting and nutritional difficulties. Ten years ago, the only palliative treatment for these patients was a bypass operation for bile flow and intestinal passage. This operation was often associated with a high morbidity. Developments in endoscopic treatments allow palliation with lower morbidity. However, stent treatment is not free of problems like stent dysfunction. During the last ten years, anesthesia and surgical techniques have developed which allow lower postoperative morbidity compared to earlier treatments. A total of 70 patients were randomized to surgery with hepaticojejunostomy on Roux loop and gastrojejunostomy or endoscopic treatment with self-expanding metallic stent in the bile duct and so-called duodenal stent. Based on the inclusion of 70 patients, we expected a 20% difference in some of the primary variables with a power of 80%.

Eligibility: Inclusion Criteria:
  -  Patients with a locally advanced periampullary neoplastic process with extrahepatic bile duct obstruction.
  -  The patient tumor burden and general condition should be such that treatment related morbidity and mortality is calculated as "reasonable" and both treatment strategies are considered "applicable".
  Exclusion Criteria:
  -  Non consent.
  -  The patients' general condition will not tolerate either treatment (strategy).
  -  Previous laparotomy or laparoscopy.
  -  Life expectancy < 3 months.
  -  Inability to participate (language, social, etc.)

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 Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail

Summary: Randomized study assessing the effect of transpapillary pancreas duct stent in resection of the pancreatic tail.

Detailed description: Resection of the pancreatic tail is fraught with fistula or leakage of pancreatic enzymes to varying degrees between 13-64%, depending upon which definition one uses. The "downstream" control of the pancreatic duct with the help of a transpapillary stent might minimize the risk for leakage over the transected pancreas surface.
  Trial evaluation will be A. The pancreatic bed was drained and postoperatively the fluid was continuously collected and daily analysed for pancreatic amylase and bilirubin. Daily measurement of pancreatic enzyme content in the drain fluid, at least for 5 post operative days or as long as the patient retains the drain. X-Amylase and X-Protein as long as the patient has the external drain.
  B. Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent.

Eligibility: Inclusion Criteria:
  -  Inclusion Criteria include all patients planned to undergo resection of the pancreatic body-tail are invited to participate.
  Exclusion Criteria:
  -  The Patients who, at the time of exploration, judged to have a tumour, which is un-resectable.

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

Clinical trial: GEM vs GEM+TS-1 for Advanced Pancreatic Cancer

Summary: The primary objective of this study is to compare tumor response rate of the test arm(gemcitabine+S-1) with the control arm(gemcitabine alone) in patients with unresectable pancreatic cancer

Detailed description: Pancreatic cancer is the fifth leading cause of cancer death in the United States. It is difficult to diagnose at its early stage and only 10-20% of patients are candidates for resection with 5-year survival rate of less than 10%. Patients with unresectable pancreatic cancer has a poor prognosis. Gemcitabine, a cytidine analogue, is the standard chemotherapeutic agent for the disease with median survival time(MST) ranging from 6 to 8 months. Phase Ⅲ study showed that combinations with other drugs, such as oxaliplatine or CDDP, did not contribute to survival time. TS-1, a new oral fluoropyrimidine which consists of the 5-FU prodrug tegafur (ftorafur, FT) and two enzyme inhibitors, CDHP (5-chloro-2,4-dihydroxypyridine) and OXO (potassium oxonate), in a molar ratio of 1(FT):0.4 (CDHP):1(OXO), is commercially available since late 90'in Japan. Phase II trials have demonstrated that S-1 was effective as a single agent for treatment of gastric (RR 44.6%), colorectal (RR 37.4%), head and neck, breast, non-small cell lung, and pancreatic cancers(20%). A combination of gemcitabine and TS-1 is found to be effective and promising in phase Ⅱ trial for metastatic pancreatic carcinoma in selected subjects, but the combination therapy has high rate of side effects. This phase Ⅱ randomized controlled study compares efficacy and feasibility of GEM+S-1 with GEM alone in patients with locally advanced and metastatic pancreatic cancer and performance status of 0-2, aiming at patients in rather ordinary clinical settings.

Eligibility: Inclusion Criteria:
  1. Histologically or cytologically proven unresectable pancreatic carcinoma
  2. There must be measurable lesions with multislice CT
  3. ECOG Performance status 0-2
  4. No other active cancer
  5. No previous therapy such as radiotherapy, chemotherapy and immunotherapy
  6. Adequate organ functions are preserved as WBC more than 4000/mm3,Hb more than 8.0g/dl,neutrophil more than 2000/mm3,platlet more than 100,000/mm3, AST less than 2.5 x normal or less than 5.0 x normal if the patient had known liver metastasis, bilirubin less than 2.0mg/dl, Ccr more than 60ml/min
  7. No serious complications
  8. Be able to eat food
  9. Life expectancy of more than 8 weeks duration
  10. Informed consent is obtained-
  Exclusion Criteria:
  1. Interstitial pneumonia
  2. Uncontrollable diabetes, liver dysfunction, angina pectoris,or myocardial infarction with its onset within 3 months
  3. Serious infection
  4. Pregnant or lactating females
  5. History of serious drug allergy
  6. Serious other complications
  7. Uncontrolled mental disorders -

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

Clinical trial: Open-label Study of CS1008 for Subjects With Untreated and Unresectable Pancreatic Cancer

Summary: Phase 2 study to determine the efficacy and safety of CS-1008 when given with gemcitabine to subjects with previously untreated and unresectable (unable to be surgically removed) or metastatic (spread to other areas beyond the pancreas) pancreatic cancer.

Detailed description: Primary Objective:
  - To evaluate the efficacy of CS-1008 administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer, based on the progression-free survival rate at 16 weeks.
  Secondary Objectives:
  -  To evaluate the efficacy of CS-1008 administered in combination with gemcitabine on overall progression-free survival rate, objective response rate, duration of response and overall survival.
  -  To determine the pharmacokinetics of C-1008 and gemcitabine
  -  To study potential biomarkers of CS-1008 activity
  -  To evaluate the safety profile of CS-1008 when administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed resectable or metastatic pancreatic cancer; not previously treated with chemotherapy; measurable disease; 18 years of age or older
  Exclusion Criteria:
  -  No anticipated need for major surgery or radiation therapy during the study
  -  Heart Disease exclusions:myocardial infarction or unstable angina within the past 6 months; severe or unstable angina pectoris within the past 6 months; coronary or peripheral artery bypass graft within the past 6 mo., etc.
  -  No clinically significant active infection or history of HIV
  -  No partial or complete bowel obstruction
  -  Cannot have poorly controlled psychiatric illness

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

Clinical trial: Expression of Inflammatory Proteins in Pancreatic Cancer

Summary: The purpose of this trial is to investigate the expression of different inflammatory proteins in cancer and normal pancreatic tissue.

Detailed description: Purpose: to investigate the expression of different inflammatory proteins in cancer and normal pancreatic tissue
  -  Trial with surgical intervention

Eligibility: Inclusion criteria:
  -  Patients with pancreatic cancer or chronic pancreatitis
  Exclusion criteria:
  -  Patients with alpha 1-antitrypsin deficiency

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

Clinical trial: A Phase 1 Study Testing CP-675,206 In Combination With Gemcitabine In Patients With Previously Untreated, Advanced Pancreatic Cancer

Summary: The purpose of this study is to determine the safety and tolerability of different doses of CP-675,206 in combination with gemcitabine and to determine the maximum dose of CP-675,206 that is well tolerated when given in combination with gemcitabine to patients with advanced pancreatic cancer.


Eligibility: Inclusion Criteria:
  -  Patients with metastatic pancreatic cancer
  -  Patient must have adequate bone marrow, liver and kidney function
  -  Patient must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
  -  Chemotherapy naive
  -  Inoperable pancreatic cancer
  Exclusion Criteria:
  -  Patient must not have received prior systemic therapy for pancreatic cancer
  -  Patient must not have previously received anti-CTLA4 therapy
  -  History of chronic inflammatory or autoimmune 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: Malabsorption Blood Test:Toward a Novel Approach to Quantify Steatorrhea

Summary: *The purpose of this study is to develop a more accurate, reliable, specific and more acceptable alternative clinical test to the 72-hour stool and diet collection for quantifying fat malabsorption in people with CF and pancreatic insufficiency.

Detailed description: -  Nine subjects with CF will be recruited to complete the MBT on two separate occasions, with different doses of pancreatic enzymes
  -  At each MBT visit, subjects will receive a specific enzyme dose just before they drink the test meal (shake)
  -  Fat absorption is maximized when the enzymes are taken with the shake.
  -  If subjects usually receive brands of pancreatic enzymes different from Creon, their dose will be converted to an equivalent dose of Creon 20 for the study.
  Prior to each study visit all subjects will be required to:
  -  Eat their usual diet for 2 days prior to MBT
  -  Refrain from consuming alcohol or dairy products for 24 hours prior to MBT
  -  Refrain from non-routine physical exercise for 20 hours prior to MBT
  -  Adhere to a 12-hour fast prior to MBT (from 8 PM previous night)
  -  Can drink water from 8:00 PM on the night before the test to 2:00 AM on the day of the test
  -  At visits 1 and 2, blood samples will be obtained at hourly intervals over a period of eight hours.
  -  Samples will be analyzed for PA, HA and Triglyceride concentrations.
  -  Patients will be permitted to ingest non-caloric and non-caffeinated beverages.
  -  At hour 6, patients will be provided 1000 Kcal, low fat (12 grams of fat) lunch meal.

Eligibility: Inclusion Criteria:
  -  Subjects with cystic fibrosis and pancreatic insufficiency (n=9), 8 years of age or older, in usual state of good health will be eligible to participate in this Aim.
  -  Subjects will be screened for genotype and a history of pancreatic insufficiency (PI). PI will be confirmed by measurement of fecal elastase 1< 200 mg/g stool.
  Exclusion Criteria:
  -  Subjects will be ineligible if they have an FEV1 % predicted of < 40%, a history of fibrosing colonopathy or any significant bowel resection (>10 cm) with the exception of a routine, uncomplicated appendectomy.
  -  Subjects with diabetes mellitus or disorders associated with altered energy metabolism (i.e. hypothyroidism), or any major illnesses that affect the gastrointestinal tract, will not be eligible for the study.
  -  Subjects with significant liver disease, or significant developmental delay will also be excluded.
  -  Subjects will be excluded if they have a food allergy related to any components of the experimental shake (i.e., soy or chocolate) or the stool marker, carmine red.
  -  Subjects who are pregnant are not eligible. Subjects with a history of intolerance or allergy to Creon 20 will be excluded from the study.

Relevance to patient case: not relevant