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

Clinical trial: Tissue Procurement for Gastric Cancer, Gastrointestinal Stromal Tumors (GIST), Esophageal Cancer, Pancreas Cancer, Hepatocellular Cancer, Biliary Cancer, Neuroendocrine, Peritoneal Mesothelioma, Anal Cancer and Colorectal Cancer in Patients Undergoing Surgery or Biopsy

Summary: The purpose of this study is to collect and store normal and malignant tissue from patients with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, an estimated 50 to 100 of each tumor type. To collect and store blood samples from patients with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer. To create a database for the collected tissue and allow access to relevant clinical information for current and future protocols. To create tissue microarrays for each gastrointestinal cancer subtype, namely, gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, to facilitate future molecular studies. To grant access to Dr Kindler, Dr. Salgia, and Dr. Catenacci to this database (as it is being acquired) of the coupled patient tissue samples (normal and malignant) and relevant clinical information for the investigation of tyrosine kinases, such as Met and Ron, receptor tyrosine kinase family members, STATs, paxillin, focal adhesion proteins, cell motility/migration proteins, tyrosine/serine/threonine kinase family members, related molecules, and downstream targets implicated in the pathogenesis of GI cancers. Examples of molecular testing include evaluation of DNA mutation, alternative splice variants, protein expression and phosphorylation, and immunohistochemistry on samples. These studies will be correlated with clinical information as stated above.


Eligibility: Inclusion Criteria:
  -  any patient diagnosed with Gastric (stomach) Cancer, Esophageal (foodpipe) Cancer, Pancreas Cancer, Liver Cancer, Biliary (gallbladder) Cancer, Gastrointestinal Stromal Tumor, Peritoneal Mesothelioma (cancer in the lining of the abdomen), Neuroendocrine (of or relating to the cells that release a hormone into the blood in response to a neural stimulus) Tumor, Anal Cancer or Colorectal Cancer cancer that requires you to undergo a surgical or diagnostic procedure.

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 to Evaluate if Neoadjuvant Radiotherapy Improves Recurrence Free Survival in Pancreatic Head Cancer

Summary: Net-Pac investigates if radiation prior to surgical resection improves survival in patients with pancreatic head cancer without metastases.

Detailed description: The trial is designed to show that neoadjuvant radiotherapy followed by surgery improves local recurrence free survival compared to surgery alone in patients with resectable adenocarcinoma of the pancreatic head.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed adenocarcinoma of the pancreatic head
  -  Age ≥ 18 years
  -  Signed informed consent
  -  ECOG performance status of 0-2
  Exclusion Criteria:
  -  Curative resection is not feasible or presence of metastatic disease
  -  Patients not eligible for surgery (ASA ≥ 4)
  -  Participation in an other clinical trial
  -  Unable or unwilling to sign the 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: Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency

Summary: This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients receiving the treatment with LipaCreon for a long term in order to evaluate the effective and safe use of LipaCreon.


Eligibility: Inclusion Criteria
  -  Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency
  Exclusion Criteria
  -  Patients with a history of hypersensitivity to the ingredient of LipaCreon.
  -  Patients with a history of hypersensitivity to porcine protein.

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

Clinical trial: Exocrine Pancreatic Function Testing in Cystic Fibrosis

Summary: Purpose The purpose of this study is to develop and validate multimodal testing of exocrine pancreatic function (EPF). The investigators will be testing exocrine pancreatic function in patients with cystic fibrosis (CF). Exocrine pancreatic function and imaging will be correlated to age group, genotype, nutritional status and quality of life. Earlier detection of exocrine pancreatic failure in the non classical form of cystic fibrosis may be of therapeutically benefit.
  Hypotheses Endoscopic short test can be applied in diagnosing and monitoring exocrine pancreatic function in patients with cystic fibrosis.
  New functional testing of exocrine pancreatic function is superior to traditional testing with fecal elastase.
  MRI and ultrasound methods can give volume output estimate in cystic fibrosis patients.
  Contrast enhanced ultrasound can quantify reduced or delayed pancreatic perfusion and parenchymal changes in cystic fibrosis patients.
  Elastography/ CEUS can be used in prediction and monitoring of fibrosis development and development of hepatocellular carcinoma in the liver of cystic fibrosis patients.
  Immunohistochemical quantification of secretin/ cholecystokinin (CCK) producing cell in duodenum can be utilized as a model hormonal signaling in cystic fibrosis patients with exocrine pancreatic function.

Detailed description: Study design: Observational, cohort studies.
  Patient characterization: Age, gender, and Genetic status from electronical records.
  Exocrine function testing (EPF): Secretin stimulated ultrasound and short endoscopic secretin test (EST). Faecal Elastase.
  Imaging: Transabdominal ultrasound of the liver and pancreas. secretin stimulated MRI. Contrast enhanced ultrasound (CEUS) of the pancreas using SonoVue contrast.
  Endpoints:
  Study 1: Exocrine pancreatic function by duodenal bicarbonate/ Enzymes related to Genetics and F elastase.
  Study 2: Ultrasound parenchymal changes of the pancreas related to Genetics and EPF.
  Study 3/4: Pancreatic secretion by ultrasound, MRI and EST related to EPF Study 5; Perfusion of the pancreas by CEUS related to EPF
  Study 6: Genotype-phenotype conciderations of the CF pancreas.

Eligibility: Inclusion Criteria:
  -  Diagnosis cystic fibrosis. Age over 15 years. Assigned to routine control at department of lung diseases, Haukeland university hospital.
  Exclusion Criteria:
  -  Unable to concent, allergies to Sonovue ultrasound contrast, pregnant or breastfeeding, contraindications against endoscopy.

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

Clinical trial: Resectability of Pancreatic Head Cancer by Contrast-enhanced MDCT:a Multi-center Study

Summary: The purpose of this multicenter and double-blind clinical trial is to prospectively assess the sensitivity, specificity, negative predictive value, positive predictive value, and accuracy in respectability of pancreatic head cancer with contrasted-enhanced MDCT and its various post processing techniques, taking operational and pathological records as the gold standard.


Eligibility: Inclusion Criteria:
  -  Patients with (or suspected) pancreatic head cancer
  -  Being examined by contrasted-enhanced MDCT
  -  Receiving surgical treatment (including palliative surgery) in all research centers
  Exclusion Criteria:
  -  Patients having (or suspected) pregnancy or breast-feeding
  -  Patients having allergic reactions to iodinated contrast agents or Hypersensitivity reactions to allergens(including drugs)
  -  Patients receiving ERCP before contrasted-enhanced MDCT examination
  -  Patients without surgery because of a high degree of surgical risk

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

Clinical trial: Small Intestinal Function in Patients With Cystic Fibrosis

Summary: In patients with Cystic fibrosis (CF) epithelial transport of chloride and sodium is disrupted in several organs such as airways, sweat glands, pancreas and intestines. Gastrointestinal symptoms are frequent but little is known about intestinal motility and function. Earlier studies using lactulose/hydrogen breath tests have found altered intestinal transit time. The method has several sources of errors and results have been questioned. This study is using a new, non invasive method to study intestinal motility patterns and transit times, Magnetic Tracking System - 1 (MTS-1).
  The aim is to compare patterns of contractility and transit times in the stomach and small intestine in adult CF- patients with healthy controls.
  Methods MTS-1 is performed without radiation and is associated with minimal discomfort for subjects. A small magnetic pill is ingest and detected by a matrix of sensors. Position and orientation of the magnet are defined by five coordinates (position: x, y, z, angle: φ, θ). Frequencies of slow waves as well as number and power of phase III contractions can be identified.
  Colorectal transit times are determined with a plain abdominal x-ray. The subjects are asked to ingest a capsule containing 10 radiopaque markers on six consecutive days up to examination. The total number of markers in the entire colorectum is counted. Total transit time, as well as segmental is calculated.
  Subjects 15 adult patients (> 18 years) with CF, homozygote for the mutation ΔF508, are studied. They are all pancreas insufficient (fecal elastase < 100 µg/g), with no previous intestinal resection or lung transplantation. None of them have diabetes. Patients are all in well-regulated pancreatic enzyme replacement therapy (PERT), thriving and with stabile weight over the last half year. They have had no treatment with antibiotics in the last 14 days up to the examination.
  The hypothesis is that patterns of contractility and transit times are the same for CF-patients in well -regulated PERT as for healthy controls.


Eligibility: Inclusion Criteria:
  -  Cystic fibrosis, severe mutations
  -  Pancreatic insufficiency(Fecal elastase < 100 µg/g)
  -  Thriving, stabile weight over the last half year
  -  No treatment with antibiotics in the last 14 days up to the examination
  Exclusion Criteria:
  -  intestinal resection
  -  lung transplantation
  -  diabetes

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

Clinical trial: Relation of Glucose and Acute Pancreatitis

Summary: Acute pancreatitis (AP) is an acute inflammatory disease of the pancreas which can lead to a systemic inflammatory response syndrome with significant morbidity and mortality in 20% of patients. Part of endocrine function of pancreas would be affected in AP. Stress hyperglycemia would explode at acute phase. So the investigators decide to follow up and observe 200 cases of patients with acute pancreatitis, determining of blood sugar, blood amylase, hemoglobin and glycosylated hemoglobin level. At last, using ROC curve method to identify the die cutting between blood glucose level and acute pancreatitis, and makes analysis of the diagnostic value.

Detailed description: Acute pancreatitis (AP) is an acute inflammatory disease of the pancreas which can lead to a systemic inflammatory response syndrome with significant morbidity and mortality in 20% of patients. Part of endocrine function of pancreas would be affected in AP. Stress hyperglycemia would explode at acute phase. There are two reasons. One is because that sympathetic hyperactivity makes glucagon elevated. Secondary, microcirculation disorder makes pancreas edema, ischemia and necrosis, affecting secretion and excretion of insulin. In severe acute pancreatitis, there may be ketoacidosis. Many scoring systems for predicting prognosis of severe acute pancreatitis also contains glucose values, such as the Ranson scoring system and the Glascow scoring system. On the other hand, Type 2 diabetes has become a global pandemic disease. Most of patients of type 2 diabetes are obese, who easily complicated gallstone disease and hypertriglyceridemia. All of above could be the risk factors for acute pancreatitis. Our initial small sample research also suggests undiagnosed diabetes patients whose glucose value elevated is significantly worse than the known diabetic patients. Therefore, the investigators believe that glucose directly affects the prognosis of AP. So the investigators decide to follow up and observe 1000 cases of patients with acute pancreatitis, determining of blood sugar, blood amylase, hemoglobin and glycosylated hemoglobin level. At last, using ROC curve method to identify the die cutting between blood glucose level and acute pancreatitis, and makes analysis of the diagnostic value.

Eligibility: Inclusion Criteria:
  patients that newly diagnosed as acute pancreatitis.
  Exclusion Criteria:
  exclude other acute abdomen, such as peptic ulcer with perforation, mesenteric arterial embolism or ruptured ectopic pregnancy.

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 Study to Evaluate the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma

Summary: This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment phase.


Eligibility: Inclusion Criteria:
  -  Initial diagnosis of metastatic pancreatic cancer must have occurred ≤6 weeks prior to the completion of screening.
  -  The presence of measurable metastatic pancreatic cancer documented by contrast enhanced CT (or MRI) scan in addition to 1 of the following:
  1. Histological diagnosis of pancreatic adenocarcinoma confirmed by pathologist OR
  2. Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreatic origin in conjunction with either:
  1. The presence of a mass in the pancreas OR
  2. A history of resected pancreatic carcinoma
  -  Measurable disease per RECIST (ver. 1.1)
  -  ECOG Performance Status of 0 or 1.
  -  Adequate hepatic, hematologic and renal functions.
  Exclusion Criteria:
  -  A history or evidence of clinically significant disorder other than metastatic cancer of the pancreas.
  -  A diagnosis of pancreatic islet neoplasms.
  -  Subject has undergone major surgery other than diagnosis surgery within 4 weeks of randomization
  -  Presence of biliary obstruction requiring external drainage
  -  Brain metastases.
  -  Unstable cardiovascular function within the last 6 months of screening
  -  Clinically active liver disease, including active viral hepatitis (HBV or HCV) or cirrhosis
  -  Known HIV infection.
  -  Uncontrolled hypertension at Screening
  -  History or presence of any form of cancer, other than pancreatic cancer, within the 3 years prior to enrollment
  -  Prior or concurrent anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) for the treatment of inoperable locally advanced or metastatic pancreatic cancer; prior radiotherapy and chemotherapy given as pre-operative neoadjuvant therapy or radio sensitizers for locally advanced pancreatic cancer are allowed.
  -  Uncontrolled systemic fungal, bacterial or viral infection
  -  Participation in an investigational drug or device trial with therapeutic intent within 30 days prior to study

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

Clinical trial: QR-Bromocriptine as an Adjunct to Insulin and Metformin in the Treatment of Type 2 Diabetes

Summary: QR-Bromocriptine as an add-on treatment to insulin and metformin in the management of type 2 diabetes will result in improved glycemic control, reduced exogenous insulin requirement, increased lean fat mass and improved pancreatic beta-cell function.

Detailed description: To assess improvement in glycemic control, reliance on exogenous insulin, improvements in lean body mass composition, and improvements in pancreatic beta-cell function.

Eligibility: Inclusion Criteria:
  1. Male and female patients, age 30 to 65 years of age,
  2. Clinical diagnosis of type 2 diabetes at least 6 months prior to enrollment,
  3. Stable on current treatment consisting of either human or recombinant multi-dose insulin therapy (MDI) with metformin,
  4. HbA1c of 7.5-12%, inclusive,
  5. Demonstrated willingness to check and record blood glucose readings at seven time points as instructed in the study protocol.
  6. Medically controlled hypertension, at least on one anti-hypertensive
  7. Medically controlled hyperlipidemia, on or off cholesterol-lowering therapy
  8. BMI >30
  Exclusion Criteria:
  1. Pregnancy or Lactating,
  2. Type 1 Diabetes,
  3. Concomitant use of forbidden medications: prescription sympathomimetics (within seven days of screening), ergot alkaloid derivatives, and anti-migraine medications,
  4. Patients with history of drug or alcohol abuse within 3 years of enrollment,
  5. Patients at risk for hypotension, including those who have:
  -  Recent blood donation within 30 days of enrollment,
  -  A history of syncopal migraines, or
  -  Significant gastroparesis or orthostatic hypotension which could signify advanced autonomic neuropathy.
  6. Uncontrolled mental illness especially with history of psychosis,
  7. Any severe, uncontrolled or terminal medical condition which the investigator feels would interfere with the patient's ability to participate and comply with the study protocol,
  8. Serum creatinine >1.4mg/dL in females or >1.5mg/dL in males that would preclude the patient from taking metformin,
  9. LFTs elevated >3x upper limit of normal,
  10. Patients working rotating, varying or night shifts, or
  11. Patient with circumstances or abnormalities (e.g. blindness or history of non-compliance) that would interfere with the interpretation of safety or efficacy data or completion of the study.

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

Clinical trial: Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase)in Patients With Pancreatic Cancer

Summary: The interest in using L-asparaginase in pancreatic cancer arose from in vitro and in vivo studies data showing an anti-neoplastic effect on pancreatic tumor cell lines. Interestingly, these studies suggest an additional effect of L-asparaginase associated to gemcitabine.GRASPA is a suspension of red blood cells encapsulating L-asparaginase. The aim of this phase I clinical trial is to evaluate the Maximum Tolerated Dose (MTD) of GRASPA on locally advanced or metastatic pancreatic tumors, after therapy failure of first or second line chemotherapy using gemcitabine.


Eligibility: Inclusion Criteria:
  -  Exocrine pancreatic adenocarcinoma cytologically or histologically confirmed
  -  Locally advanced and non-resectable with invasion of the superior mesenteric artery (stage III) or metastatic (stage IV) as defined by TNM 2002 classification (UICC 2002)
  -  resistant to a first or second line chemotherapy with gemcitabine
  -  Patient aged between 18 to 70 years
  -  Signed Informed Consent Form
  -  Life expectancy ≥ 12 weeks
  -  Accurate measurement of tumor volume by imagery (in at least one dimension)
  -  Presence of one or several tumor markers (CEA and CA 19.9)
  -  ECOG Prognostic Score : 0, 1 or 2
  -  Patient beneficiary of a Social Security Insurance
  Exclusion Criteria:
  -  Patient with an endocrine or acinar pancreatic tumor
  -  Patient with known or suspected cerebro-meningeal metastases
  -  Haemoglobin level greater than 13 g/L
  -  Patient hypersensitive to L-asparaginase or have had prior exposure to any form of L-asparaginase
  -  Splenic vein thrombosis < 3 months or under active treatment
  -  Anti-vitamin K treatment
  -  Hepatic Insufficiency unrelated to pancreatic cancer
  -  Renal insufficiency unrelated to pancreatic cancer
  -  Pancreatitis or pancreatitis history unrelated to pancreatic cancer
  -  Insulin-dependant diabetes mellitus unrelated to pancreatic cancer
  -  Current or prior coagulopathy disorders unrelated to pancreatic cancer
  -  ECOG Prognostic Score 3 or 4
  -  History of grade 3 blood transfusion reaction (life threatening situation)
  -  Presence of rare and dangerous anti-erythrocyte antibodies preventing from getting a compatible packed Red Blood Cells for the patient
  -  Patient already included in another clinical trial
  -  Pregnancy, breast-feeding or absence of secured contraception
  -  Unwillingness to sign the informed consent form

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

Clinical trial: Serum DCAMKL1 Pre and Post Treatment in Patients With Pancreatic Cancer

Summary: The investigators believe DCAMKL-1 is a stem cell tumor marker and is elevated in patients with pancreatic cancer. The investigators would like to analyze its expression pre and post treatment, to gauge the correlation between current pancreatic cancer therapies and the expression of DCAMKL-1


Eligibility: Inclusion Criteria:
  -  pancreatic cancer
  Exclusion Criteria:
  -  age < 18, history of other types of cancer

Relevance to patient case: not relevant