araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Proton Therapy for Unresectable Cancer (CA) of Pancreas

Summary: The purpose of this study is to find out what effects, good and/or bad, proton radiation and chemotherapy has on you and your pancreatic cancer.

Detailed description: Chemotherapy:Capecitabine on radiation days
  Proton radiation over 7 weeks
  Consolidation Chemotherapy:Gemcitabine

Eligibility: Inclusion Criteria:
  Pathologically confirmed adenocarcinoma of the pancreas.
  Patients must be medically inoperable or have unresectable disease
  Exclusion Criteria:
  -  Evidence of distant metastasis; evidence of metastatic disease in the major viscera (organs), peritoneal seeding and/or ascites.
  -  Previous irradiation to the abdomen that would compromise the ability to deliver the prescribed treatment.
  -  Prior surgical resection.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Docetaxel Plus Oxaliplatin as Therapy in Patients With Pancreatic Cancer

Summary: The purpose of this study is to test a combination-therapy of oxaliplatin and docetaxel in patients with metastatic or locally advanced adenocarcinoma of the pancreas after failure of a palliative first line therapy.

Detailed description: For years Fluorouracil was the established treatment for pancreatic cancer with median survival times up to 8 months. Since 1997 Gemcitabine is also a standard therapy with in comparison to Fluorouracil a significant better clinical benefit.
  But after progression of the disease under a palliative first-line therapy there is no established second line therapy for pancreatic cancer.
  So the purpose of this study is to test the combination of Oxaliplatin and Docetaxel in patients with metastatic or locally advanced adenocarcinoma of the pancreas after failure of a palliative first line therapy to get a reasonable second line concept.

Eligibility: Inclusion Criteria:
  -  Dated and signed informed concent
  -  Histologically or cytologically proven metastatic or locally advanced adenocarcinoma of the exocrine pancreas (stadium UICC III/IV)
  -  Presence of at least one measurable (according to RECIST criteria) marker lesion (primary tumor or metastasis) outside of an area that was previously subjected to radiation therapy
  -  Failure of a palliative first line therapy of a metastatic or locally advanced adenocarcinoma of the exocrine pancreas due to: Progress within 3 months after a first-line therapy Discontinuation of a first-line therapy due to toxicity
  -  Age >= 18 years
  -  Karnofsky index > 60%
  -  Expected live span > 12 weeks
  -  Sufficient bone marrow reserve: Granulocytes >= 1.5 x 109/L and Platelets >= 100 x 109/L and Hemoglobin >= 9 g/L
  -  Serum Bilirubin < 2 x upper normal limit or 2.5 x upper normal limit in case of hepatic metastasis (biliary drainage allowed)
  -  AST/ALT < 2.5 x upper normal limit
  Exclusion Criteria:
  -  Every other cancer or secondary cancer besides the basal cell carcinoma of the skin or the carcinoma in situ of the cervix uteri. Inclusion of patients with other types of cancer that were successfully treated and that did not relapse within the last 5 years is possible
  -  Pregnancy or lactation
  -  Patients able to reproduce that do not adhere to strict contraception
  -  Presence of brain metastasis
  -  Severe, uncontrolled infection
  -  Preexisting peripheral neuropathy > grade I
  -  Preexisting severe illnesses such as unstable coronary artery disease or uncontrolled cardiac arrhythmia
  -  Justified disbelief in the compliance of the patient
  -  Parallel participation in another clinical trial

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Relationship Between Polymorphism of Heat Shock Protein 70 Gene and Hepatocellular Carcinoma

Summary: Polymorphisms of HSP70 and tumor necrosis factor-alpha promoter in patients with hepatocellular carcinoma, chronic liver disease and healthy controls will be measured by PCR-RFLP or direct sequencing. The clinical relevance of patients will be compared in those with polymorphism and those without.

Detailed description: Heat shock protein 70 (HSP 70) may be involved in various aspects of immune system including infection, autoimmunity, and tumor immunity. The relationship between HSP70 expression, disease activity and cancer prognosis varied according to type of cancer. The overexpression of HSP70 by tumor cells contributes to tumor behavior. HSP70 is present in normal and abnormal hepatocytes, and was reported to be over-expressed in both hepatoma cell lines and human hepatocellular carcinoma (HCC) tissue. Recent study indicated that HSP70 is a molecular marker during early hepatocarcinogenesis. It is also involved in anti-tumor immunity in HCC.We also investigate the polymorphism of tumor necrosis factor-alpha promoter, and correlated to clinical relevance.

Eligibility: Inclusion Criteria:
  -  History proven HCC patients
  Exclusion Criteria:
  -  No-definite diagnosed patients

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: The Effect of Pancreatic Polypeptide on Insulin Requirements for Type 1 & Post-pancreatectomy Diabetic Patients

Summary: The goal of this research is to see if pancreatic polypeptide (PP), a hormone that is naturally produced by the pancreas and that works to control the amount of glucose that the liver makes, will reduce the amount of insulin required for people who must take insulin to maintain their normal blood glucose level.

Detailed description: The pancreas is a large gland located behind the stomach. One of the functions of the pancreas is to produce two hormones: insulin and pancreatic polypeptide. Insulin helps the cells to take in glucose. The liver makes glucose and insulin normally acts to decrease or shut off the liver's production of glucose. However, in patients whose pancreas no longer makes insulin or makes low levels of pancreatic polypeptide the liver cannot perform these duties as well. Studies have shown that these important functions of the liver are improved for these patients when pancreatic polypeptide is given together with their insulin. Because PP increases the liver's sensitivity to insulin and thereby reduces the amount of glucose produced by the liver, this will result in fewer swings in blood sugar levels both in the upper and lower range. With fewer swings in blood glucose, a patient should decrease the amount of insulin used. One of the main benefits of lowering total insulin requirement is a reduction in the development of dangerous low blood sugar levels.

Eligibility: Inclusion Criteria:
  -  Male and female volunteers between the ages of 18-75 with:
  -  10 subjects who are status post pancreatic resection and 10 volunteers who are Type 1 diabetic for > 8 years (volunteers must have a stable glycemic profile that includes use of an insulin pump to control their blood glucose) with or without prior pancreatic resection.
  -  HbA1c levels ≤ 8.5.
  Exclusion Criteria:
  -  Lactating or pregnant females.
  -  Brittle or Labile diabetics: Volunteers with extremely erratic patterns of glucose control with large fluctuations in glucose levels for no obvious reason.
  -  Allergy to beef or beef by-products.
  -  Hypoglycemia within the past year requiring medical or other assistance to correct.
  -  Known autonomic neuropathy.
  -  Documented blood glucose under 60 mg within the past year and hypoglycemic unawareness.
  -  Durations of type 1 DM ≤ 8 years.
  -  Not currently on pump therapy.
  -  Type 1 DM who has a BMI ≥ 35.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Intraoperative Celiac Plexus Neurolysis for Patients With Operable Pancreatic and Periampullary Cancer

Summary: Determine if the addition of an intraoperative ethanol celiac plexus neurolysis (alcohol block) in patients undergoing surgical intervention for pancreatic cancer will result in a decrease in cancer associated pain

Detailed description: Pancreatic adenocarcinoma is the fourth leading cause of cancer related death in the United States and is usually fatal. Surgery provides the only chance for long-term survival. Pain is a significant, often difficult to control component of survivorship for many who succumb to this disease. The purpose of this trial is to evaluate the effect of ethanol celiac plexus neurolysis (alcohol nerve block) in patients undergoing surgical intervention for pancreatic cancer. Patients undergoing surgery for pancreatic cancer will be enrolled in a prospective randomized double blind placebo controlled clinical trial.
  This protocol is designed to definitively determine the role of ethanol celiac plexus neurolysis as a simple addition to the surgical management of pancreatic adenocarcinoma and help define the standard of care for cancer associated pain management in this disease.

Eligibility: Inclusion Criteria:
  -  Preoperative imaging indicates possibility of resectable pancreatic cancer
  -  Intraoperative biopsy histologically confirming pancreatic adenocarcinoma
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Study of PEP02 as a Second Line Therapy for Metastatic Pancreatic Cancer

Summary: The purpose of this study is to see the effect of PEP02 in the treatment of metastatic pancreatic cancer.

Detailed description: Gemcitabine monotherapy or a gemcitabine-based combination regimen is the standard first line therapy for advanced pancreatic cancer. After disease progression, there is no standard treatment available. In animal studies and a previous phase I trial, PEP02 has shown anti-tumor activity and preliminary efficacy in pancreatic cancer. In addition, a phase II study of free-form irinotecan single agent has already shown encouraging activity as second-line treatment for patients with advanced pancreatic cancer refractory to gemcitabine. The liposome formulation of PEP02 theoretically has therapeutic advantages over free-form irinotecan, such as site-specific delivery and extended release of drug. Hence PEP02 may be able to provide better efficacy than free-form irinotecan.
  The primary purpose of this phase II study is to evaluate the activity of PEP02 as a second-line therapy in patients with metastatic pancreatic cancer failed to gemcitabine treatment. The primary goal is to measure the 3-month survival rate. An optimal Simon's 2-stage design will be used for this exploratory phase II study.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
  -  Metastatic disease
  -  Documented disease progression after treatment with 1 line of prior gemcitabine-based regimen
  -  Karnofsky performance status equal or more than 70
  Exclusion Criteria:
  -  With active CNS metastases
  -  With clinically significant gastrointestinal disorder (e.g., bleeding, inflammation, occlusion, or diarrhea > grade 1)
  -  Major surgery or radiotherapy within 4 weeks
  -  Prior participation in any investigational drug study within 4 weeks
  -  With prior irinotecan treatment

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients

Summary: Pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP), a procedure for the diagnosis and treatment of disorders of the pancreas and bile duct.
  Preliminary data has shown that non-steroidal antiinflammatory drugs, when administered rectally, can reduce the risk of pancreatitis after ERCP. This study is intended to definitively determine whether rectally administered indomethacin (a non-steroidal antiinflammatory drug)is effective at preventing pancreatitis after ERCP.

Detailed description: This study is a multi-center, randomized, placebo-controlled, double-blinded clinical trial of rectal indomethacin in the prevention of post-ERCP pancreatitis in high risk patients.

Eligibility: Inclusion Criteria:
  Included patients are those undergoing ERCP and have one of the following:
  1. Clinical suspicion of sphincter of Oddi dysfunction
  2. History of post-ERCP pancreatitis (at least one episode)
  3. Pancreatic sphincterotomy
  4. Pre-cut (access) sphincterotomy
  5. > 8 cannulation attempts
  6. Pneumatic dilation of intact biliary sphincter
  7. Ampullectomy
  or at least 2 of the following:
  1. Age < 50 years old & female gender
  2. History of recurrent pancreatitis (at least 2 episodes)
  3. ≥3 pancreatic injections, with at least one injection to tail
  4. Pancreatic acinarization
  5. Pancreatic brush cytology
  Exclusion Criteria:
  1. Unwillingness or inability to consent for the study
  2. Age < 18 years
  3. Intrauterine pregnancy
  4. Breast feeding mother
  5. Standard contraindications to ERCP
  6. Allergy to Aspirin or NSAIDs
  7. Renal failure (Cr > 1.4)
  8. Active or recent (within 4 weeks) gastrointestinal hemorrhage
  9. Acute pancreatitis (lipase peak) within 72 hours
  10. Known chronic calcific pancreatitis
  11. Pancreatic head malignancy
  12. Procedure performed on major papilla/ventral panc duct in pt with pancreas divisum (no manipulation of minor papilla)
  13. ERCP for biliary stent removal or exchange without anticipated pancreatogram
  14. Subjects with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram
  15. Anticipated inability to follow protocol
  16. Endoscopist discretion: low risk (<10%) of post-ERCP pancreatitis

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Collecting Medical Information and Tissue Samples From Patients With Pancreatic Cancer or Other Pancreatic Disorders

Summary: RATIONALE: Gathering medical information and collecting and storing samples of blood and tissue to test in the laboratory may help doctors develop better ways to screen people at risk for pancreatic cancer or other pancreatic disorders in the future.
  PURPOSE: This clinical trial is collecting medical information and tissue samples from patients with pancreatic cancer or other pancreatic disorders.

Detailed description: OBJECTIVES:
  Primary
  -  To collect clinical data and family histories and blood and/or tissue samples from patients diagnosed with pancreatic diseases, including pancreatic cancer, for use in future studies.
  -  To collect information regarding food preparation and intake in these patients.
  Secondary
  -  To make available to researchers medical data and biospecimens to enable them to develop better ways to screen people at risk for pancreatic conditions, including pancreatic cancer.
  -  To investigate genes or substances that increase susceptibility of developing pancreatic conditions.
  -  To find agents that may help prevent, treat, or cure these conditions.
  -  To learn whether inherited factors increase the risk of pancreatic diseases, pancreatic cancer, or other cancers.
  OUTLINE: This is a multicenter study.
  Patients complete two 1-hour surveys assessing health, clinical and family history of pancreatic conditions including cancer, and food preparation and intake. Patients also complete a 15- to 30-minute follow up survey at 6 months and 1 year to assess health, health practices, and family history. A review of the patient's medical information is obtained from the medical record.
  Blood samples are collected for future research studies. Oral cells and stool samples may also be collected for future studies.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis or suspicion of at least one of the following:
  -  Pancreatic cancer
  -  Pancreatic mass
  -  Islet cell tumor
  -  Intraductal papillary mucinous neoplasms (IPMN)
  -  Hereditary pancreatitis
  PATIENT CHARACTERISTICS:
  -  Able to understand and read English
  -  Mentally competent and able to provide informed consent
  -  Has not donated blood within the past 8 weeks
  PRIOR CONCURRENT THERAPY:
  -  At least 7 days since prior blood transfusion
  -  At least 7 days since prior surgery

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Collecting Blood and Tissue Samples From Family Members of Patients With Pancreatic Diseases, Pancreatic Cancer, and Melanoma

Summary: RATIONALE: Collecting and storing samples of blood and tissue from family members of patients with cancer to test in the laboratory may help the study of cancer in the future.
  PURPOSE: This clinical trial is collecting blood and tissue samples from family members of patients with pancreatic disease, pancreatic cancer, and melanoma.

Detailed description: OBJECTIVES:
  -  To collect clinical history, family history, and blood and/or tissue samples from family members of patients diagnosed with pancreatic diseases, pancreatic cancer, or melanoma.
  -  To learn whether inherited factors increase the risk of pancreatic diseases, pancreatic cancer, or other cancers.
  OUTLINE: Study participants undergo collection of blood and/or tissue samples as well as survey data for inclusion in a familial data and tissue registry. Participants complete two baseline surveys regarding their personal, family, health, and environmental exposure histories and regarding their opinions on cancer and cancer screening. Patients also complete a follow-up survey at 1 year and undergo review of their medical records.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  Has at least 2 blood relatives with pancreatic cancer (both must be related)
  -  Has at least 1 blood relative with pancreatic cancer and 1 with melanoma (both must be related)
  PATIENT CHARACTERISTICS:
  -  Mentally competent and able to provide informed consent
  -  Able to understand and read English
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Anastomotic Techniques in Pancreaticoduodenectomy

Summary: There are two principal ways of draining the remnant of the pancreas back into the intestine after removal of the head of the pancreas for cancer. This can be performed either to the jejunum or to the stomach. The aim of this study is to randomly allocate consenting patients to one of the two arms to study whether the leak rates from the anastomosis and the outcomes after the surgery are affected.
  Previous papers have shown similar results in both groups although non randomized data suggested that the Pancreaticogastrostomy (drainage into the stomach) may be superior


Eligibility: Inclusion Criteria:
  1. Pancreaticoduodenectomy for adenocarcinoma of the pancreatic head
  2. resectable tumour
  Exclusion Criteria:
  1. chronic pancreatitis/benign tumours-
  2. tumours extending into the body of the pancreas
  3. tumours with metastasis beyond regional lymph nodes
  4. requirement for sub total pancreatectomy
  5. prolonged hypotension - < 80 mm of hg for more than 30 min

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Level of HER2-neu Gene Amplification an Response to Trastuzumab

Summary: Primary objective of the study is to evaluate the correlation between level of HER2-neu gene amplification evalued by dual-color Fluorescent in-situ hybridization (FISH) test and time to progression (TTP) in patients with HER2-positive advanced breast cancer treated with trastuzumab-containing regimens.


Eligibility: Inclusion Criteria:
  -  HER2-positive breast cancer Trastuzumab-containing regimen delivered for advanced disease Tumor sample available at Pathology Archive
  Exclusion Criteria:
  -  HER2-negative advanced breast cancer Pretreatment with trastuzumab

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Gemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic Cancer

Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
  PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given together with capecitabine and erlotinib in treating patients with advanced pancreatic cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the maximum-tolerated dose of the combination of gemcitabine hydrochloride, capecitabine, and erlotinib hydrochloride in patients with advanced pancreatic cancer.
  Secondary
  -  Analyze the limiting toxicities according to CTC.
  -  Analyze the toxicity according to CTC.
  -  Determine the recommended dose.
  -  Determine the pharmacokinetic dosages of the three drugs.
  -  Analyze interactions between the drugs.
  OUTLINE: This is a multicenter study.
  Patients receive one course of chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, oral capecitabine twice daily on days 1-21, and oral erlotinib hydrochloride once daily on days 1-28.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed adenocarcinoma of the pancreas
  -  Advanced disease
  -  No standard curative therapy available
  -  Must have received prior first-line chemotherapy
  -  No brain metastasis
  PATIENT CHARACTERISTICS:
  -  WHO performance status 0-2
  -  Life expectancy ≥ 8 weeks
  -  ANC ≥ 1.5 x 10^9/ L
  -  Platelet count ≥ 130 x 10^9/ L
  -  Hemoglobin ≥ 10 g/dL
  -  Liver transaminases ≤ 1.5 times upper limit of normal (ULN) (≤ 5 times ULN in the presence of liver metastases)
  -  Bilirubin ≤ 1.5 times ULN
  -  Creatinine ≤ 130 mmol/L OR creatinine clearance > 30 mL/min
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  No intolerance or hypersensitivity to any of the drugs being tested
  -  No history of interstitial lung disease
  -  No history of severe cardiac disease
  -  No serious uncontrolled infection
  -  No rare hereditary disorders, i.e., galactosemia, lactase deficiency, or malabsorption of glucose or galactose syndrome
  -  Must not be deprived of liberty or under guardianship
  -  Must not be on probation
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No prior erlotinib hydrochloride
  -  No concurrent potent inducers or inhibitors of cytochrome P450 or CYP3A4
  -  More than 14 days since participation in another clinical trial

Relevance to patient case: not relevant