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

Clinical trial: A Phase 1/2 Trial of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 as Neoadjuvant Chemotherapy in Locally Advanced, Unresectable Pancreatic Cancer

Summary: This is a Phase 1/2 trial to evaluate the safety, tolerability and efficacy of FG-3019 administered with gemcitabine and Nab-paclitaxel in the treatment of locally advanced, unresectable pancreatic cancer.

Detailed description: Each subject may receive up to six cycles of treatment (each treatment cycle is 28 days). Tumor tissue will be collected during resection for biomarker analysis. EUS core tumor biopsies will be collected pre/post treatment at participating centers. Tumor response will be evaluated by changes in CT scan, FDG-PET, CA 19-9, and NCCN® guidelines.
  Subjects who complete 6 cycles of treatment will be evaluated for surgical exploration for possible R0 resection. Subjects who undergo surgery will be evaluated for surgical complications for an additional 30 days following discharge from surgery. All subjects will be followed for safety for 28 days following their last dose with study drug. Blood samples will be collected periodically for the assessment of pharmacokinetics (PK) and pharmacodynamics (PD).
  All subjects, including those who discontinue from the study during the treatment period without evidence of disease progression, will be followed for at least 28 weeks post End of Treatment for disease progression, survival, and follow-on treatment for pancreatic cancer.

Eligibility: Key Inclusion Criteria:
  -  Male or non-pregnant, non-lactating female
  -  Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)
  -  Radiographic and pathologic staging consistent with pancreatic cancer, locally advanced, unresectable (per NCCN criteria)
  -  Laparoscopic confirmation that PDAC is locally advanced. Biliary stents are permitted
  -  Measurable disease as defined by RECIST 1.1
  -  ECOG performance status 0 or 1
  -  Adequate liver, bone marrow and renal function
  -  Agree to use contraception per protocol
  -  Less than Grade 2 pre-existing peripheral neuropathy
  Key Exclusion Criteria:
  -  Prior chemotherapy or radiation for pancreatic cancer
  -  Solid tumor contact with SMA > 180°
  -  Previous (within the past 5 years) or concurrent malignancy diagnosis (expect non-melanoma skin cancer or in situ carcinoma of the cervix)
  -  Major surgery within 4 weeks prior to Day 1 study
  -  History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies
  -  Exposure to another investigational drug within 42 days of first dosing visit, or 5 half-lives of the study product (whichever is longer)
  -  Uncontrolled intercurrent illness
  -  Any medical condition that, in the opinion of the Investigator, may pose a safety risk to a subject in this trial, may confound the assessment of safety and efficacy, or may interfere with study participation.
  -  Current abuse of alcohol or drugs

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

Clinical trial: Randomized, Controlled Trial of Endoscopic Ultrasound-Guided Bilateral Celiac Plexus Neurolysis vs Celiac Ganglia Neurolysis to Control Pain in Inoperable Pancreatic Cancer Patients With Inadequate Pain Control by Pain Killer

Summary: Pancreatic cancer related pain can be difficult to control, even with high doses of narcotics, whose adverse effects may further impair quality of life. So EUS-CPN(endoscopic ultrasound guided celiac plexus neurolysis) is well established as an effective technique for controlling pain and reducing narcotic requirements in patients with pancreatic cancer. Recently, celiac ganglia can be visualized and accessed by endoscopic ultrasound. So it allows for direct injection into individual celiac ganglia to perform celiac ganglia neurolysis. This more precise delivery of therapeutic drug will offers the potential for enhanced efficacy and safety. To evaluate this hypothesis, this randomized controlled trial aimed to compare the efficacy and safety of EUS-CGN(Endoscopic ultrasound guided celiac ganglia neurolysis) vs. Bilateral EUS-CPN(Endoscopic ultrasound guided celiac plexus neurolysis) in providing relief from pancreas cancer-related pain.


Eligibility: Inclusion Criteria:
  1. At least 19 years old age (above 70 years old age, need the consent of the legal representative)
  2. Inoperable pancreatic cancer patients
  3. Pancreatic cancer patients with inadequate pain control by pain killer (VAS score 4 points or more)
  4. Patient who agree to participate in this study
  Exclusion Criteria:
  1. Abnormal clotting (international normalized ratio ≥1.5)
  2. Reduced platelet count (≤50000/μL)
  3. Use of anticoagulation agents
  4. Presence of gastric and/or esophageal varices
  5. Anatomical deformity due to past 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: Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Digestive System

Summary: Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects. The main purpose is to identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma.

Detailed description: Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects.
  1. Main purpose
  1. To identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma.
  2. To explore the largest mechanical index and ultrasonic treatment time which patients can endure.
  2. Secondary purpose
  1. To observe tumor clinical benefit rate (CR+PR+SD).
  2. To evaluate the preliminary effect,such as time to failure(TTF), time to death(TTD)

Eligibility: Inclusion Criteria:
  -  Pathological diagnosis of liver metastases from alimentary system and pancreatic carcinoma
  -  Failed routine chemotherapy
  -  Neoplasms can be evaluated by imaging
  -  ECOG《2
  Exclusion Criteria:
  -  Have systematic chemotherapy in 2 weeks
  -  Be allergic to ultrasonic microbubbles and chemotherapeutics
  -  Uncontrolled high blood pressure, cardiovascular disease
  -  Active bleeding
  -  Have serious mental and psychological disease

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

Clinical trial: Longitudinal Pancreatic Cancer Study

Summary: To obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting longitudinal specimens from subjects diagnosed with any stage of pancreatic cancer.

Detailed description: The study objectives are described below:
  1. Obtain serum and plasma specimens longitudinally collected from approximately 140 subjects diagnosed with pancreatic cancer and are about to or are currently undergoing treatment and follow-up. Specimens will be used to evaluate CA 19-9 assays, currently under development, as an aid for monitoring recurrence or progressive disease.
  2. To store any remaining specimens for use in future cancer research and to evaluate as yet undetermined biomarkers for the development of IVDs, including additional CA 19-9 assays, for monitoring the course of disease and therapy in subjects diagnosed with pancreatic cancer.

Eligibility: Inclusion Criteria:
  -  Males and females, age≥ 18 years
  -  Histologic/pathologic confirmation of exocrine pancreatic cancer
  -  Any stage of disease: Newly diagnosed, stable, disease progression
  -  Any treatment time point: Treatment naïve, currently receiving or completed therapy for pancreatic cancer including active monitoring.
  -  Individuals with a history of malignant disease other than pancreatic cancer that was resected greater than 5 years ago and are currently in remission are eligible.
  -  Life expectancy greater than 6 months
  -  Able to understand and willing to provide informed consent
  Exclusion Criteria:
  -  Males and females, age <18 years
  -  No histologic/pathologic confirmation of exocrine pancreatic cancer
  -  Life expectancy less than 6 months
  -  Any concurrent malignancy other than basal or squamous cell skin cancers or in-situ cervical cancer.
  -  Unable to provide informed consent

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 Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

Summary: This is a multi-center, randomized, double-blinded, placebo controlled trial in pre-menopausal women with advanced breast cancer.

Detailed description: The purpose of this study is to assess the efficacy of LEE011, as measured by progression free survival (PFS), in premenopausal women with HR positive, HER2 negative advanced breast cancer

Eligibility: Inclusion Criteria:
  -  Patient has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy
  -  Patient is premenopausal or perimenopausal at the time of study entry
  -  Patients who received (neo) adjuvant therapy for breast cancer are eligible
  -  Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer
  -  Patient has HER2-negative breast cancer
  -  Patient must have either measurable disease or If no measurable disease is present, then at least one predominantly lytic bone lesion
  -  Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  -  Patient has adequate bone marrow and organ function
  Exclusion Criteria:
  -  Patient who has received a prior CDK4/6 inhibitor
  -  Patient is postmenopausal
  -  Patients who currently have inflammatory breast cancer at screening.
  -  Patients who received any prior hormonal anti-cancer therapy for advanced breast cancer, except for ≤ 14 days of tamoxifen or NSAI ± goserelin for advanced breast cancer prior to randomization.
  -  Patient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated basal cell skin carcinoma, squamous cell skin carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
  -  Patient with CNS metastases.
  -  Patient has active cardiac disease or a history of cardiac dysfunction
  -  Patient is currently using other antineoplastic agents
  -  Patient is pregnant or nursing or physiologically capable of becoming pregnant and not using highly effective contraception

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

Clinical trial: Rollover Protocol for Subjects Who Have Responded on Study 4218s - A Phase 2 Study

Summary: Subjects achieving a clinical response in study OX4218s with a biomarker reduction or symptom response are eligible to enroll in this rollover study to continue once every three weeks fosbretabulin infusions for up to one year.

Detailed description: Subjects enrolled in the PNET/GI-NET study OX4218s received weekly dosing with fosbretabulin for up to 3 cycles or approximately 9 weeks. Subjects achieving a clinical response with a biomarker reduction or symptom response based on investigator assessment are eligible to enroll in this rollover study (protocol OX4219s). Subjects will receive fosbretabulin every three weeks for a maximum of approximately one year or until disease progression, unacceptable toxicity, consent withdrawal, protocol-noncompliance, or the investigator feels that it is no longer in the subject's best interest to continue therapy.

Eligibility: Inclusion Criteria:
  -  Subject has been treated in the OXiGENE-sponsored Phase 2 study OX4218s
  Exclusion Criteria:
  -  Subject has not received fosbretabulin treatment in the study OX4218s

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 Pre-operative Pathway in Pancreatic Head Malignancy-assessment of the Diagnostic Accuracy of Staging CT Scan

Summary: Our aim is to assess the ability of scans to distinguish the organ of origin of pancreatic head malignant tumours and to predict the resectability based on the preoperative imaging. To achieve this, a retrospective review of the preoperative CT scans will be conducted for all patients with pancreatic head malignancy treated at the Peninsula Hepato-Pancreatico-Biliary (HPB) cancer unit between January 2006 till January 2014.

Detailed description: Pancreatic cancer arises from the glandular part of the pancreas and is the fifth most common cause for cancer related death in the UK. It. Ampullary carcinoma arises from the epithelium of the ampulla of Vater into which the common bile duct and pancreatic duct drain. Cholangiocarcinoma arises from the bile duct epithelium, and may occur within the intra-pancreatic portion of the distal common bile duct mimicking a pancreatic malignancy. Cancers arising from these origins often cause obstructive jaundice and are hard to distinguish. Surgery is indicated for the treatment of these types of malignant tumours, and the definitive final diagnosis is usually not known until the specimen is examined. This situation does not allow specific treatment to be given pre-operatively, so-called 'neo-adjuvant therapy'. The rationale for this approach is that in a proportion of patients the tumour will be made smaller by this treatment, which may facilitate surgical resection.

Eligibility: Inclusion Criteria:
  -  All patients who have undergone surgery for presumed pancreatic malignancy in Derriford Hospital between Jan 2006 and Jan 14 will be included.
  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: Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC)

Summary: This clinical study is in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. The study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of treatment. Subjects who complete the treatment will choose, with their treating physicians, what additional treatment should be given: more nab-Paclitaxel plus gemcitabine, Chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer.

Detailed description: This is an international, non-randomized, open-label, multi-center, Phase 2 study in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. All subjects will be treated with nab-paclitaxel plus gemcitabine for 6 cycles followed by an Investigator's Choice of continuation of treatment with nab-paclitaxel plus gemcitabine, chemoradiation therapy, or surgery.
  Safety assessments by laboratory testing and physical exams will be conducted through-out the study.
  Efficacy assessments by physical exam will be preformed through-out the study and tumor imaging will be conducted approximately every 2 months.
  Subjects will be considered active study participants from enrollment up to, but not including, survival follow-up period.

Eligibility: Inclusion Criteria:
  -  Non- metastasis, unresectable, adenocarcinoma pancreatic cancer patients
  -  No prior anticancer therapy for pancreatic cancer
  •≥ 18 years of age with a performance status of 0 or 1•Adequate complete blood counts, hepatic function, and renal function
  -  Signed informed Consent
  Exclusion Criteria:
  -  Active bacterial, viral, or fungal infection
  -  Infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or receiving immunosuppressive or myelosuppressive
  -  Subjects with sensory neuropathy, ascites, or plastic biliary stent.
  -  Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders (including but not limited to connective tissue disorders, lung disease, and cardiac or seizure disorders)
  -  Women who are pregnant or breast feeding

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

Clinical trial: Follow-up Study of Complications of Acute Pancreatitis

Summary: This is a follow-up study focusing on long-term complications of acute pancreatitis. The primary purposes include: 1. To assess the incidence of type 2 diabetes mellitus（2-DM）,impaired glucose tolerance, metabolic abnormalities of blood lipids after acute pancreatitis. 2. To observe the possible long-term clinical outcomes after acute pancreatitis attack, which may include: chronic pancreatitis, pancreatic cancer, pancreatogenic portal hypertension, autoimmune pancreatitis et al. 3. To evaluate the long-term influence of acute lung injury(PaO2/FiO2<200,FiO2 means fraction of inspiration O2) in AP patients during ICU stay on life qualities of the patients; 4. To observe the prognosis of the local complications of acute pancreatitis(AP) patients; it might be helpful to find the most effective and targeted interventions aiming at different phases after AP attack.

Detailed description: Currently，follow-up study is limited on glucose intolerance and life quality assessment. However, it has been shown that AP is associated to some extent with other diseases such as chronic pancreatitis, pancreatic cancer, pancreatogenic portal hypertension and autoimmune pancreatitis; In addition, for patients who have severe lung injury following AP, especially with PaO2/FiO2<200 during ICU stay, the long term prognosis remains unclear. Thus, a large sample follow-up study is essential for elucidating the possible long-term complications.
  Prior to follow up study, the investigators performed baseline analysis of AP patient data from the database of the First Affiliated Hospital of Nanchang University. It is estimated that 1300 patients will be interviewed over telephone and 600 patients in the outpatient department. The content of the follow-up includes: questionnaire (the MOS[medical outcome study] item short from health survey, SF[short form]-36) ; lab testing(complete blood count, blood chemistry such as liver and kidney function, C-reaction protein(CRP), AMY, fasting blood-glucose，1 and 2 hour postprandial blood glucose,C-peptide, blood lipids, FE-1) and CT scan. For patients who have severe lung injuries during ICU stay, pulmonary function test, Blood gas analysis and chest CT will be performed. After screening, the patients with chronic pancreatitis(CP), pancreatic cancer(PC), post Pancreatogenic portal hypertension（PPH） or autoimmune pancreatitis(AIP）will be hospitalized for further therapy.

Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of acute pancreatitis from our hospital
  -  Must be signed the informed consent
  Exclusion Criteria:
  -  Failed to complete the questionnaire survey and the follow-up examination

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

Clinical trial: Pancreatic Cancer Screening of High-Risk Individuals in Arkansas

Summary: 100 subjects who have a family history of pancreatic cancer (PC), or known genetic syndromes associated with increased risk of pancreatic cancer, will be followed for five years. This data will be used to determine the pancreatic cancer and precancerous lesion detection rate in High Risk Individuals (HRIs). Subjects may agree to annual imaging and annual biomarkers or to biomarkers only.


Eligibility: Inclusion Criteria:
  -  Have a family history of PC as listed below or who have one of the following syndromes: Peutz-Jeghers syndrome - STK11; BRCA 1 and 2; PALB2; ATM; FAMMM / P16; HNPCC (Lynch) / MMR genes; Hereditary pancreatitis - PRSS1
  -  Individuals with three or more affected blood relatives (1st, 2nd or 3rd degree)
  -  Individuals with two or more affected blood relatives with PC, with at least one affected FDR, should be considered for screening.
  -  Patients with a history of Peutz-Jeghers syndrome should be screened, regardless of family history of PC.
  -  Patients with a known p16 (FAMMM syndrome) with one affected 1st or 2nd degree relative will be considered for screening.
  -  Patients with a known BRCA1 or BRCA2 mutation with one affected 1st or 2nd degree relative should be considered for screening.
  -  Patients with a known PALB2 mutation with one affected family member should be considered for screening.
  -  Patients with a known Mismatch-repair gene-mutation carriers (Lynch syndrome) with one affected family member should be considered for screening.
  Exclusion Criteria:
  -  Not candidates for 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: Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis

Summary: One of the major elements of successful endoscopic retrograde cholangiopancreatography ( ERCP) is the timely and uncomplicated cannulation of the common bile duct (CBD) . Various factors may adversely affect the cannulation procedure of the CBD leading to complications (acute pancreatitis after ERCP, perforation of the duodenum , bleeding ). Endoscopic sphincterotomy is frequently required for interventional procedures (eg stone extraction). During sphincterotomy, incision of the orifice of the papilla will be performed by using a sphincterotome. Complications due to sphincterotomy are known: Bleeding, increased rates of acute pancreatitis, small bowel perforation and scarring with consecutive stenosis of the papilla. As an alternative to sphincterotomy, balloon dilatation using balloon catheters can be performed. As a result, bleeding complications and scarring as late effects might be prevented. Current data is limited in terms of the risk of acute pancreatitis after ERCP when using a balloon catheter.
  This study aims to evaluate the incidence of acute pancreatitis and other complications after ERCP. Balloon dilatation of the papilla will be prospectively compared with endoscopic sphincterotomy in a randomized multicenter setting.


Eligibility: Inclusion Criteria:
  -  independent indication for ERCP
  -  age ≥ 18 years
  -  patient is able to understand informed consent
  Exclusion Criteria:
  -  S/p sphincterotomy
  -  pancreatic or CBD-stent in situ
  -  pregnant patient
  -  known chronic pancreatitis
  -  acute pancreatitis prior to intervention

Relevance to patient case: not relevant