araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer

Summary: The aim of this study is to test the additional value of neoadjuvant chemotherapy to the standard treatment for resectable pancreatic cancer (surgery + adjuvant chemotherapy).
  This study will be performed in compliance with the study protocol, GCP (good clinical practice) and the applicable regulatory requirements.


Eligibility: Inclusion Criteria:
  -  resectable adenocarcinoma of the pancreatic head (requiring duodeno-pancreatectomy)
  -  T1-3, Nx, M0 (UICC 6th version, 2002)
  -  infiltration of the portal vein (<180°) is not an exclusion criterion
  -  cytologic or histologic confirmation of adenocarcinoma
  -  age >18 years
  -  written informed consent
  Exclusion Criteria:
  -  contraindication for Whipple procedure
  -  an infiltration >180° of the portal vein
  -  abutment of the tumor to the superior mesenteric artery
  -  infiltration of the superior mesenteric artery or the celiac trunk
  -  chronic neuropathy > grade 2
  -  WHO performance score >2
  -  uncorrectable cholestasis (bilirubin > 100mmol/l despite drainage attempts for more than four weeks prior to inclusion)
  -  female patients in child bearing age not using adequate contraception (oral or subcutaneous contraceptives, intrauterine pessars (IUP), condoms)
  -  pregnant or lactating women
  -  mental or organic disorders which could interfere with giving informed consent or receiving treatments
  -  Second malignancy diagnosed within the past 5 years, except non-melanomatous skin cancer or non-invasive cervical cancer
  -  percutaneous biopsy of the primary tumor

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: Optimal Number of To-and-fro Motion in EUS-guided Fine Needle Aspiration for Pancreatic Masses

Summary: EUS-FNA is the standard of care for diagnosing pancreatic masses. According to the operator's preference, EUS-FNA with suction or without suction technique has been used. To date, little is known about optimal number of to-and-fro motion during each needle pass. As usual 10-15 to-and-fro motions was used for EUS-FNA with suction technique. Theoretically, more number of to-and-fro motions may be required in EUS-FNA without suction. In this circumstance, the contamination of blood in specimen and possible adverse event may occur. To determine optimal number of to-and-fro motion in EUS-guided FNA for pancreatic masses in terms of with suction or without suction, this prospective single-blinded randomized trial was conducted.

Detailed description: For this prospective single-blinded randomized trial, two 10cc syringes was prepared. Two syringe was provided as same performance. However, one syringe is falsely made as suction syringe (fake one). During EUS-FNA, two syringe is randomly assigned and loaded by a nurse. Thus, operator was blinded which syringe is with suction or without suction.
  First hypothesis: There is difference in the diagnostic accuracy of pancreatic masses according to EUS-FNA with suction or without suction/ different number of to-and-fro motion.
  Second hypothesis: There is difference in the amount of blood in samples obtained by EUS-FNA with suction or without suction/ different number of to-and-fro motion.

Eligibility: Inclusion Criteria:
  -  Age > 19 years Solid pancreatic mass lesions
  Exclusion Criteria:
  -  Age < 19 years Coagulopathy Unable to consent

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: Evaluation of Drug Activity in Women With Breast Cancer and no Previous Herceptin Treatment

Summary: To compare the activity of AZD8931 against placebo on the cell markers in cancer tumours

Detailed description: A Randomised Double-Blind Placebo-controlled Multicentre Phase I Study to Assess the Biological Activity of AZD8931 in Patients with Early Breast Cancer who are Ineligible for Treatment with trastuzumab as defined by IHC status

Eligibility: Inclusion Criteria:
  -  Females aged 18 or older Early stage breast cancer and planned surgery
  -  Ineligible for Trastuzumab (Herceptin) treatment as per local guidelines
  -  World health Organisation performance status of 0 to 1 Tumour size amenable to obtaining adequate biopsies pre dosing.
  Exclusion Criteria:
  -  Eligible for Trastuzumab (Herceptin) Treatment Known sensitivity to AZD8931, its excipients or drugs in its class;
  -  Including oral tyrosine kinase inhibitors History of eye conditions e.g. previous injury within 3 months or clinically significant eye disease
  -  Concurrent malignancy Unable to discontinue medication or herbal supplement known to inhibit CYP3A4 or CYP2D6

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer

Summary: Depression and anxiety accompany with advanced cancer. The effect of anti-anxiety depression has not evaluated in special cancers. Mirtazapine is a drug anti-anxiety depression and has a high risk increase weight. So the investigators assume Mirtazapine would not only improve the anxiety and depression of metastasis pancreas cancer but also would improve the appetite of such patients which would improve dyscrasia of pancreas cancer patients. The drug may improve the quality of life in advanced pancreatic cancer which is of short survival.

Detailed description: The investigators design a phase II/III trial to compared Mirtazapine plus gemcitabine with gemcitabine in metastasis pancreatic cancer. The investigators planed to enroll 33 patients for each arm after randomization.
  The inclusion criteria included:
  1. Patients shall have normal organic function such as liver function, Cardiac function and renal function.
  2. Before enrolled, anxious and depression states will be evaluated by the Hamilton degree of depression and anxiety scale. Only patients with definite depression and/or anxiety will be considering participating this trial.
  3. Pancreatic cancer patients with ECOG 1～2 scores will be enrolled.
  4. Patients should be expected to live no shorter than 1.5 months
  The investigators will evaluated the quality of life by SF-36 scale as primary outcome. The second outcomes include anxious and depression scores, objective response rate, progress free survival, overall Survival and chemotherapy induced nausea and vomiting.

Eligibility: Inclusion Criteria:
  1. Patients of pancreatic cancer shall have normal organic function such as liver function, cardiac function and renal function.
  2. Before enrolled, anxious and depression states will be evaluated by the Hamilton degree of depression and anxiety scale. Only patients with definite depression and/or anxiety will be considering participating this trial.
  3. Pancreatic cancer patients with ECOG 1～2 scores will be enrolled.
  4. Patients should be expected to live no shorter than 1.5 months
  Exclusion Criteria:
  1. Patients receiving other anti-cancer drugs;
  2. Patients who discontinue anti-cancer drugs less than 4 weeks, for patients who received Postoperative adjuvant chemotherapy less than 6 weeks. Shorter than 4 weeks after operation;
  3. Patient with inadequate Blood system,liver function and renal function.
  4. Brain metastasis is of symptoms
  5. Patient with arrhythmia,myocardial ischemia,serious atrioventricular block,inadequate cardiac function,serious valvular heart disease;
  6. Chronic enteritis or intestinal obstruction
  7. Bone marrow failure
  8. Mental disease difficult to control
  9. Participated other clinic trial within 3 months
  10. Pregnant or lactation patients
  11. The researcher evaluate the patient is not suitable for this trial.

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: OSI-906 With Gemcitabine and Erlotinib for Metastatic Ductal Adenocarcinoma of the Pancreas

Summary: OSI-906 is a new drug that may stop cancer cells from growing abnormally. This drug has been used in other research studies and information from those suggests that OSI-906 may help block cell receptors involved in tumor growth.
  Gemcitabine and erlotinib are used as standard treatment for pancreatic cancer. In this research study, the investigators are looking for the highest dose of OSI-906 that can be given safely in combination with gemcitabine and erlotinib. This dose will then be given together with gemcitabine and erlotinib to a further group of patients with pancreatic cancer.

Detailed description: This study will be conducted in two parts: a phase I study and a phase II study. In both instances, a treatment cycle is 28 days (4 weeks). Subjects will take OSI-906 by mouth, twice a day, every day. Subjects will receive gemcitabine through an IV in clinic over 30 minutes on days 1, 8 and 15 of each 28-day cycle. Subjects will take erlotinib by mouth, once a day, every day.
  At every visit subjects will have a physical exam and blood tests. An EKG will be done on days 1, 8 and 15 of cycle 1 and on day 1 of all subsequent cycles. A CT scan will be done every 2 cycles (8 weeks).
  Subjects will complete a daily drug diary and perform glucose monitoring (finger stick) once daily at home.

Eligibility: Inclusion Criteria:
  -  Metastatic pancreatic ductal adenocarcinoma
  -  Measurable disease
  -  Life expectancy > 12 weeks
  -  Normal organ and marrow function
  -  Fasting blood glucose </= 150 mg/dL
  -  Able to swallow pills
  Exclusion Criteria:
  -  Prior chemotherapy or radiotherapy for treatment of pancreatic cancer
  -  Receiving any other experimental agent
  -  Known brain metastases
  -  History of allergic reaction attributed to compounds of similar chemical or biologic composition to gemcitabine, erlotinib, or OSI-906
  -  Impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea)
  -  Use of enzyme-inducing anti-epileptic drugs
  -  Diabetes mellitus which requires the use of exogenous insulin for glucose control
  -  Major surgery within 4 weeks of the start of study treatment
  -  Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  -  Use of strong or moderate CYP1A2 inhibitors/inducers
  -  Pregnant or breast feeding
  -  History of a different malignancy unless disease-free for at least 3 years
  -  HIV positive

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: A Phase 1 Dose Escalation Study of AV-203, an ERBB3 Inhibitory Antibody, in Subjects With Advanced Solid Tumors

Summary: This is a Phase 1, multi-center, open-label, multiple dose, dose escalation study to evaluate the safety, tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D), pharmacokinetic (PK), pharmacodynamics, and preliminary anti-tumor activity of AV-203, an ERBB3 inhibitory antibody, administered once every 2 weeks via intravenous (IV) infusion in subjects with metastatic or advanced solid tumors. Once the RP2D is determined, patients with tumor types of interest will be evaluated in an expansion cohort at the RP2D for safety and anti-tumor activity.


Eligibility: Inclusion Criteria:
  -  ≥ 18 years of age
  -  Histologically and/or cytologically confirmed primary diagnosis
  -  Metastatic or advanced solid tumor, that has recurred or progressed following standard therapies, or for which no standard therapy exists
  -  Must have available tumor tissue or be willing to undergo biopsy prior to enrollment
  -  Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
  -  Blood Chemistry and Hematology results within defined limits
  Exclusion Criteria:
  -  History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent
  -  Current central nervous system (CNS) or leptomeningeal metastases, or history of CNS or leptomeningeal metastases.
  -  Significant conduction disturbance, history of a severe arrhythmia, or history of a familial arrhythmia
  -  Significant cardiovascular disease
  -  Significant thromboembolic or vascular disorders within prior 3 months
  -  Any other medical condition or psychiatric condition that, in the opinion of the Investigator, might interfere with the subject's participation in the trial or interfere with the interpretation of trial results
  -  Known history of positive results for hepatitis C, hepatitis B, or human immunodeficiency virus.
  -  For female subjects, pregnancy or lactation.

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: EUS Guided Celiac Neurolysis

Summary: -  Hypothesis:
  - Direct CGN enhances neurolytic drug delivery into celiac ganglia and increases the efficacy of neurolysis and subsequent pain control and survival in patients with pancreatic carcinoma.
  -  Rationale:
  -  Standard CPN leads to inaccurate delivery of the injectate with rapid dispersal thereby only briefly remaining in contact with neural structures and limiting the degree of neurolysis. Poor targeting and delivery of a neurolytic agent may result in diminished neurolysis and decrease efficacy.


Eligibility: Inclusion Criteria:
  -  1. Unresectable pancreatic carcinoma (T4 or M1) or advanced T3 disease
  -  2. Cytologic or histologic confirmation of pancreatic carcinoma
  -  3. Abdominal pain (≥ 3 on NRS scale), ≥ 2 days/week, lasting ≥ 1 hour/ day, stable intensity for ≥ 7 days
  -  4. EUS clinically indicated (for non-study purposes)
  Exclusion Criteria:
  -  1. Uncorrectable coagulopathy: (INR) > 1.5 and/or platelets < 50,000
  -  2. Abdominal surgery within 1 month
  -  3. Prior celiac plexus or ganglia neurolysis.
  -  4. Initiation or modification in chemotherapy or radiotherapy within prior 7 days.
  -  5. Direct tumor infiltration of the celiac trunk and/or celiac ganglia.

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: Tissue Study of Bv8/PK-2 Inhibition in Human Cancer

Summary: Study hypothesis is that inhibition of Bv8 production in bone marrow cells of a mice wil reduce the rate of growth of a primary human tumor implanted in the mice. we will take mice and transform their bone marrow cells into non-Bv8 producing cells. than we will implant primary human tumor tissue (taken from surgical specimens after informed consent)in those mice and follow-up on the mice.

Detailed description: 1-10 grams of human cancer tissue will be taken from surgical specimen without interference to the pathological data gathering process. those tissues will be implanted in nude mice that will either be treated with anti-Bv8 antibodies or will be transplanted with bone marrow in which Bv8 expression is silenced.

Eligibility: Inclusion Criteria:
  -  ages 18-85 years
  -  Pathologically-confirmed diagnosis of pancreatic ductal adenocarcinoma undergoing surgical pancreaticoduodenectomy
  Exclusion Criteria:
  -  refuse to take part
  -  preoperative chemotherapy

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: Ultrasound-assisted Treatment of Inoperable Pancreatic Cancer

Summary: The investigators primary aim is to increase chemotherapeutic drug uptake in inoperable tumours
  The specific sub-objectives of the studies are:
  -  To quantify tumour sizes and relate it to the patient survival over time, dependent of treatment method.
  -  To evaluate and compare the toxic effects and safety of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone.
  -  Develop and validate new ultrasound perfusion algorithms based on burst- replenishment for diagnosis and monitoring of therapy.
  -  To quantify gemcitabine and its main metabolites in plasma and in circulating mononuclear cells before, during and after pancreatic sonication, and to quantify the concentration of intracellular endogenous nucleotides in circulating mononuclear cells at the same time points.
  -  To assess plasma and tissue concentrations of gemcitabine, its main metabolites and endogenous nucleotides in those patients where surgical resection can be performed on standard clinical indications.

Detailed description: The primary outcome is monitor for toxicity effect for the combination therapy.

Eligibility: Inclusion Criteria:
  -  Patients with inoperable pancreatic cancer (ICD-10 C25.0-3) at the Department of Surgical Gastroenterology of Haukeland University Hospital, who have volunteered to participate
  Exclusion Criteria:
  -  Patient participated in an investigational study within 30 days prior to study entry (or, if longer, within five half-lives of the last dose of any investigational drug).
  -  Patient has severe chronic obstructive pulmonary disease or severe chronic asthma.
  -  Patient has a history of cardiovascular ischemia, acute myocardial infarction or unstable angina within 3 months prior to study entry.
  -  Patient has a history of any psychiatric disorder or cognitive impairment that would interfere with participation in the study.
  -  Patient has a known history of Hepatitis B, Hepatitis C or HIV infection.
  -  Patient requires dialysis or has severely impaired renal function, defined as a serum creatinine > 180 mmol/L at the Screening Visit.
  -  Patient has severe impairment of liver function, defined as a serum albumin level ≤ 25 g/L and/or a Protrombin Time INR > 2.3 (or APTT > 6 seconds above the upper limit of normal) at the Screening Visit.
  -  Patient is pregnant or is breast-feeding.
  -  Patient is allergic to or intolerant of gemcitabine
  -  Patient is allergic to or intolerant of SonoVue® BRACCO ultrasound contrast agent
  -  Any reason why, in the opinion of the investigator, the patient should not participate.

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: Pancreatic Juice Diagnosis From Duodenum

Summary: Purpose of this study is to understand the clinical feasibility of duodenal juice diagnosis to screen UICC stage II pancreatic ductal adenocarcinoma patients.

Detailed description: Pancreatic cancer (PC) is the most lethal of all major cancers with a five year survival rate of 5 %. While stage I and II tumors leads to an improvement in survival, almost all PCs are currently diagnosed at more advanced non-resectable stages since minimally invasive technique which is capable of screening early-stage PC does not exist. Serum CA19-9 is not recommended as a screening technique because of its low sensitivity and specificity. Imaging modalities such as MRI, CT, EUS and ERCP are more accurate but are not appropriate screening tools due to their high cost, discomfort and complications. Therefore, there is a strong demand for a screening tool with high sensitivity and specificity which is highly acceptable for the patient.
  The investigators would like to standardize the detection method of pancreatic cancer that uses the duodenal juice as an optional endoscopic diagnosis. It's a very useful chance to collect pancreatic juice from duodenum, it is called "duodenal juice" ,if we collect them without additional invasion. The investigators would like to collect duodenal juice during undergoing upper gastrointestinal endoscopy and analyze the pancreatic tumor markers in duodenal juice. A definite diagnosis of the patient is made with histology, cytology or imaging diagnosis and the result of each definite diagnosis is correlated to the each marker analyzing result of duodenal juice. Therefore this study can be positioned as a feasibility study to confirm clinical performance.

Eligibility: Inclusion Criteria:
  -  Common inclusion criterion
  -  Age is 18 years or older.
  -  Informed consent was obtained.
  -  Inclusion criterion for normal cohort
  -  An upper GI endoscopy is scheduled to check upper abdominal symptoms.
  -  No findings of pancreatic disorder as documented by CT or MRI or EUS
  -  Inclusion criterion for PC suspicious cohort
  -  A EUS or ERCP is scheduled to suspected pancreatic disorder.
  Exclusion Criteria:
  -  Common exclusion criterion
  -  Severe cardiac disease
  -  Severe respiratory disease
  -  Bleeding disorders
  -  Pregnancy

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors

Summary: This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-141 at varying dose levels and frequencies.


Eligibility: Inclusion Criteria:
  -  Advanced malignant solid tumors for which no curative therapy exists that has recurred or pgrogressed following standard therapy
  -  Eighteen years of age or above
  -  Able to understand and sign an informed consent (or have a legal representative who is able to do so)
  -  Measurable disease according to RECIST v1.1
  -  ECOG Performance Score of 0 or 1
  -  Adequate bone marrow, hepatic, renal and cardiac function
  -  Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-141
  Exclusion Criteria:
  -  Active infection or fever > 38.5°C during screening visits or on the first scheduled day of dosing
  -  Symptomatic CNS disease
  -  Received other recent antitumor therapy
  -  Pregnant or breast feeding

Relevance to patient case: not relevant