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

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: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

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: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Safety Study of Radiofrequency Ablation of Locally Advanced Pancreatic Cancer

Summary: The purpose of the study is to determine the safety of radiofrequency ablation of locally advanced pancreatic cancer that can not be surgically removed with the current standard procedures. Complications after the operation will be registered. Moreover a pain score will be determined, length of hospital stay, chemotherapy, survival, progression free survival and a tumour marker.

Detailed description: Pancreatic cancer is the fourth leading cause of cancer related death in the Western world. At time of diagnosis, 20% of patients present with a resectable tumour, 40% with an irresectable locally advanced tumour (without metastases) and 40% with metastatic disease. The median survival of patients with irresectable locally advanced pancreatic cancer is only 6 months. Currently, there is no effective treatment for these patients. Therefore, there is an urgent need for new therapies. Radiofrequency ablation (RFA) is a technique that has been demonstrated to be effective in the treatment of several irresectable tumours. RFA produces local tumour destruction through high frequency alternating current flowing from an electrode implanted directly into the tumour and causing frictional heating. The purpose of this study is to determine the safety of RFA-pancreas in patients with non-metastasized, irresectable, locally advanced pancreatic cancer.

Eligibility: Inclusion Criteria:
  1. Patients with irresectable locally advanced pancreatic cancer found at laparotomy with histologic diagnosis before start of RFA
  2. Patient considered eligible to undergo pancreatic surgery as assessed by the general criteria of the departments of anaesthesiology and surgery of the UMC Utrecht
  3. Fully informed written consent given
  Exclusion Criteria:
  1. Patients younger than 18 years
  2. Pregnancy
  3. Patients with distant metastases
  4. Portal vein thrombosis seen on CT preoperatively

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

Clinical trial: Effect of Gastrectomy and Anastomosis on Diabetes and Hypertension in Early Gastric Cancer Patients

Summary: The purpose of this study is to determine whether the extent of gastrectomy and anastomosis type affect chronic metabolic disease such as diabetes and hypertension in early gastric cancer patients.


Eligibility: Inclusion Criteria:
  -  Histologically proven primary gastric adenocarcinoma
  -  clinical stage Ia or Ib examined with endoscopy, endoscopic ultrasound, and computed tomography
  -  aged 20-80 year old,
  -  performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
  -  diagnosed as diabetes or hypertension
  -  patients planning to undergo gastrectomy or endoscopic submucosal dissection
  -  written informed consent
  Exclusion Criteria:
  -  having high risk for operation such as severe heart disease, severe respiratory disease
  -  pregnant
  -  previous abdominal surgery or radiation therapy
  -  proven more advanced disease than pathological stage II requiring adjuvant chemotherapy

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

Clinical trial: Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer

Summary: The purpose of this study is to find out whether Endoscopic Ultrasound (EUS) can detect early stage pre-cancerous or cancerous changes in the pancreas in patients at high-risk for the development of pancreatic cancer. Endoscopic refers to the use of an instrument called an endoscope - a thin, flexible tube with a tiny video camera and light on the end. Ultrasound refers to an imaging technique that uses sound waves to produce pictures. EUS in this research study is a method of combining endoscopy and ultrasound imaging to obtain high quality images of the pancreas.


Eligibility: Inclusion Criteria:
  -  Patients will be eligible if they have 2 or more relatives with pancreatic cancer and have a first degree relationship with at least one of the relatives with pancreatic cancer
  -  If only 2 family members are affected then both must have had pancreatic cancer and a first-degree relationship with individual screened
  -  If there are more than 2 affected individuals on the same side of the family at least one of the individuals must have a first-degree relationship with the member being screened
  -  Patients at least 40 years old or 10 years younger than the youngest affected individual
  -  Peutz-Jeghers Syndrome (PJS) patients age>30
  -  Hereditary pancreatitis patients
  -  Patients with Familial Atypical Multiple Mole Melanoma Syndrome (FAMMM)
  -  Patients with BRCA2 mutation and at least one first or second degree relative with documented pancreatic cancer
  -  Willingness to undergo (EUS) with possible Fine Needle Aspiration (FNA)
  -  Willingness to undergo surgical evaluation for abnormal EUS/FNA finding
  -  Willingness to undergo radiographic evaluation if screening findings are abnormal
  Exclusion Criteria:
  -  Medical contraindications to undergoing endoscopy or obstruction of the GI tract that precludes passage of the endoscope
  -  Personal history of pancreatic adenocarcinoma
  -  Previous partial or complete resection of the pancreas for adenocarcinoma
  -  Prior partial or total gastrectomy with Billroth II or Roux-en-Y anastamosis
  -  Previous computed tomography (CT) scan, magnetic resonance imaging/magnetic resonance cholangiopancreatography (MRI/MRCP) or EUS of the abdomen in the past 3 years
  -  Coexisting cancer in other organs or acquired immunodeficiency syndrome/human immunodeficiency virus (AIDS/HIV)
  -  Life expectancy less than 5 years
  -  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: Biomarkers Study in Pancreatic Cancer

Summary: Study Design:
  Patients are eligible if (1) enrolled to TCOG 3207(2) received surgery or biopsy for pancreatic cancer; (3) willing to sign informed consent.
  The pancreatic tumor, tissue specimen and blood sample before or after treatment will be collected from department of pathology, surgery or diagnostic medicine.

Detailed description: We expect to collect tissue samples from 270 pancreatic cancer patients of any stages. Since the enrollment criteria are not limited to new patients, we expect to enroll 67 patients a year. The patient enrollment will be completed in 4 years. Clinical follow-up will be completed in another one year. Data analysis and correlation study may be finished in the end of 5th year of this study.

Eligibility: Inclusion Criteria:
  1. Patients enrolled to TCOG 3207 study: A Randomized Phase III Study of Adjuvant Gemcitabine versus Gemcitabine Plus Concurrent Chemoradiation in Pancreatic Cancer Underwent Curative Intent (R0 / R1) Resection.
  2. Patients who were not eligible for TCOG 3207 study but received surgery or biopsy for pancreatic cancer.
  3. Patients have to sign informed consent for tissue specimen collection, according to the regulation of DOH.

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

Clinical trial: Identifying Saliva Markers of Patients With Stomach, Colorectal (Including Pre-cancer Polyp) and Pancreatic Cancers

Summary: Colorectal cancers account for 783,000 new cases and cause 437,000 deaths per year across the world. Diagnosis in the early stages improves survival rates. Up to now, these cancers are mostly diagnosed only at later stages of the disease's course through histoimmune staining and molecular biology processes on the tissues biopsied from the gastrointestinal system under invasive diagnostic procedures of colonoscopy.
  Oral fluid presents a large protein complexity and has been recently used as a diagnostic biofluid for oral, as well as systematic diseases. Using oral fluid as a bio-marker for the colorectal cancer can be advantageous as it contains gastrointestinal fluids, in addition to bacteria and bacteria lysate, which can also serve as a bio-markers' source for colorectal cancers. Proteomic technologies provide the tools needed to discover and identify disease-associated biomarkers.
  The aim of the present study is to identify salivary bio-markers in patients suffering from colorectal cancers.


Eligibility: Inclusion Criteria:
  -  Has not yet started treatment for the identified cancer
  Exclusion Criteria:
  -  medically compromised patients
  -  congenital syndromes
  -  being treated with radiotherapy or chemotherapy.

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

Clinical trial: Early Diagnosis of Oral Cancer by Detecting p16 Methylation

Summary: The purpose of this study is to verify the function of p16 methylation diagnostic reagents in early diagnosis of oral cancer.

Detailed description: Background:Oral epithelial dysplasia (OED) is one of the common precancerous lesions among Chinese adults. To investigate the clinical predictive value of p16 methylation diagnostic reagents in the early diagnosis of oral cancer, the investigators carried out the prospective multi-center double-blind cohort study.
  Methods:180 patients with histologically confirmed mild or moderate OED were included in the present study. The investigators using p16 methylation diagnostic reagents to analysis of the p16 methylation status in these patients. Building two follow-up queue by p16-methylated and p16-unmethylated. The Statistical analysis used SAS6.12 software. All P-values were two-sided. P<0.05 was considered to test for statistical significance difference.

Eligibility: Inclusion Criteria:
  -  Histopathological diagnosis of oral lesions meet the epithelial diagnostic criteria for mild to moderate grade OED
  -  No local area stimulate by residual root and crown, sharp cusp, poor restoration and biting cheek or lips
  -  Without the OCE treatment history by laser , radiation or chemical
  -  Be able to Sign the informed consent
  Exclusion Criteria:
  -  Histopathological diagnosis of oral lesions do not meet the epithelium of mild to moderate dysplasia diagnostic criteria; histological diagnosis of severe grade OED or malignant disease
  -  Pregnancy or breast-feeding women
  -  Serious heart, lung, liver , kidney and other systemic diseases
  -  local area stimulate by residual root and crown, sharp cusp, poor restoration and biting cheek or lips
  -  OED treatment history by LASER, radiotherapy, or chemotherapy
  -  Tumor and psychiatric patients
  -  Patients are unable to cooperate

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

Clinical trial: Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy

Summary: Pancreaticoduodenectomy is a surgical procedure for removing cancer in the pancreas, the bile system or the duodenum that is associated with a high rate of complications. The study wants to investigate whether a new technique to reconstruct the joint between the pancreatic gland and the short bowel can reduce the rate of severe complications after this complex surgical procedure.

Detailed description: Pancreaticoduodenectomy is a complex surgical procedure for radically resecting tumors in the pancreatic head, distal bile duct or duodenum. Postoperative pancreatic fistula is the main contributor of severe postoperative morbidity after pancreaticoduodenectomy. Characteristics of the pancreatic gland like soft pancreatic consistency and small pancreatic main duct predispose for the postoperative fistula development. In high risk patients, the risk of suffering from associated postoperative morbidity is 50 percent which is considered unacceptable high. The aim of the current trial is to investigate whether a new anastomosing technique for the pancreaticojejunostomy can reduce the incidence of associated postoperative morbidity in patients undergoing pancreaticoduodenectomy.

Eligibility: Inclusion Criteria:
  -  Patients scheduled for elective pancreaticoduodenectomy
  -  Pancreatic gland with high risk criteria for associated postoperative morbidity
  Exclusion Criteria:
  -  Patients do not accept participation
  -  Pancreatic gland with intermediate or low risk criteria for associated postoperative morbidity

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

Clinical trial: Detection of Cancer-Specific Active Proteases in Blood Via Fluorescence

Summary: The primary objective is to develop a rapid in vitro screening assay for detection of pancreatic cancer biomarkers in blood of patients with pancreatic cancer.

Detailed description: The goal of the project is to develop a rapid in vitro screening assay for detection of cancer biomarkers in blood. The aim is testing and optimization of nanoparticle sensors, based on cyanine dyes that are chemically linked to Fe/Fe3O4 nanoparticles via protease-selective consensus (cleavage) sequences. The focus is on the quantitative determination of active cancer-specific proteases in blood via simple fluorescence measurements. The matrix metalloproteinases, urokinase-type plasminogen activator, and cathepsins, are up-regulated in the vast majority of progressing cancers and can, therefore, serve as markers for cell survival/tumor progression, angiogenesis, and tissue remodeling/invasion

Eligibility: Inclusion Criteria:
  Inclusion Criteria for Pancreatic Cancer Patients:
  -  Patients will either have a histologic diagnosis of pancreatic carcinoma or a clinical picture consistent with pancreatic cancer and will be undergoing surgery or a diagnostic procedure to confirm the diagnosis.
  -  Patients will have had no prior treatment or surgery
  Inclusion Criteria for Healthy Subjects:
  -  Subjects will have no prior history of any cancer
  Exclusion Criteria:
  Exclusion Criteria for Pancreatic Cancer Patients
  -  Any prior treatment for pancreatic cancer
  -  Poorly controlled diabetes
  Exclusion Criteria for Healthy Subjects
  -  Poorly controlled 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: Effectiveness of Two Sealant Materials Over 5 Years

Summary: The purpose of this study is to assess the effectiveness of a new hydrophilic sealant (Ultraseal XT Hydro) compared to the previously existing hydrophobic sealant materials (Ultraseal XT Plus) which requires prime and dry to dry the tooth surface.

Detailed description: The new hydrophobic sealant material eliminates the step of prime and drying the tooth which prevents from over drying the tooth surface and decreases chair time, which is important when working with children. The null hypothesis is that there is no difference between the materials. The alternate hypothesis is that the Ultraseal XT Hydro is a better material.

Eligibility: Inclusion Criteria:
  -  Children that are at a high risk of developing caries.
  Exclusion Criteria:
  -  Children that already have sealants or do not need them.

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

Clinical trial: BrUOG 278: FOLFOX-A For Pancreatic Cancer A Brown University Oncology Research Group Study

Summary: The purpose of this study is to test the safety, activity and best doses of FOLFOX-A which consists of the standard chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and abraxane. Each of these drugs are currently used in pancreatic cancer.
  The experimental part of the study is combining these drugs together in FOLFOX-A.

Detailed description: More active treatments are desperately needed in pancreatic cancer. The regimen of FOLFIRINOX increases survival as compared to gemcitabine but at a cost of increased toxicity. Irinotecan is responsible for much of the toxicity of FOLFIROX but may not contribute significantly to the regimen's activity. Abraxane is a new agent in pancreatic cancer. This albumin-bound nanoparticle form of paclitaxel increases tumor accumulation of paclitaxel though binding of albumin to SPARC in pancreatic cancer stroma. The investigators therefore propose a pilot study of FOLFOX (fluorouracil, leucovorin and oxaliplatin) combined with abraxane to establish the safety and preliminary activity of FOLFOX-A. Patients with inoperable (metastatic and locally advanced) pancreatic cancer will be eligible since the primary outcome is to establish the safety of FOLFOX-A.

Eligibility: Inclusion Criteria:
  -  Pathologically confirmed pancreatic ductal adenocarcinoma.
  -  Metastatic or locally advanced disease.
  -  No prior treatment for pancreatic cancer
  -  Radiographically measurable disease.
  -  No major surgery within 4 weeks of the start of study treatment. Patients must have recovered from the side effects of any major surgery at the start of study treatment. Laparoscopy and central venous catheter placement are not considered major surgery.
  -  Patients with serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive FOLFOX-A
  -  Preexisting neuropathy > grade 1.
  -  No prior invasive malignancy within the prior two years. However, patients with an early stage malignancy that is not expected to require treatment in the next 2 years (such as early stage, resected breast cancer or asymptomatic prostate cancer) are eligible.
  -  ECOG performance status 0 or 1.
  -  Age ≥ 18 years of age.
  -  Not pregnant and not nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to beginning of treatment.
  -  Required Initial Laboratory Values:
  -  Neutrophils ≥ 1,500/μl
  -  Platelet count ≥ 100,000/μl
  -  Creatinine ≤ 1.5 mg/dL -or- creatinine clearance ≥ 60 mL/min
  -  Total bilirubin ≤ 1.5 x ULN
  -  AST (SGOT) & ALT (SGPT) ≤ 3.0 x ULN
  Exclusion Criteria:
  -Patients with known brain metastases

Relevance to patient case: not relevant