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

Clinical trial: Neostigmine Treatment of Acute Pancreatitis Combined With Intra-abdominal Hypertension

Summary: Acute pancreatitis with Intra-abdominal Hypertension have high mortality rate, intra-abdominal pressure mainly because of intestinal paralysis which due to edema, intestinal gas, fluid and other intestinal dysfunction.Neostigmine is an anti-cholinesterase drugs, can enhance intestinal peristalsis, promote flatus, defecation. This study will determine the efficacy of neostigmine in the treatment of acute pancreatitis with Intra-abdominal Hypertension.

Detailed description: The treatment of acute pancreatitis with Intra-abdominal hypertension still no ideal method. At present, through fasting, fluid resuscitation, prevention of shock, to correct acid-base balance and electrolyte imbalance, acid suppression, inhibition of pancreatic secretion, rational use of antibiotics and other general of conservative treatment, such as the failure of conservative treatment may be open decompression surgery, but trauma, and high mortality. Therefore an urgent need to explore and establish effective treatment IAH and Abdominal compartment syndrome to improve SAP's cure rate and reduce mortality.
  Neostigmine as an anti-cholinesterase drugs, through acetylcholine in cholinergic transmission and cholinesterase competitively binding site, inhibiting the hydrolysis of acetylcholine, enhance and strengthen the role of cholinergic excitatory parasympathetic activity , restore the patient's bowel movements, so that the body showed a muscarinic (M-like) effect. When gastrointestinal M receptor stimulant can enhance intestinal peristalsis, promote flatus, defecation.
  The investigators observed neostigmine can effectively promote intestinal gas, fluid emptying, thereby reducing intra-abdominal pressure. Therefore, prospective studies are needed to clearly worth neostigmine in the treatment of acute pancreatitis with IAH efficacy and safety.

Eligibility: Inclusion Criteria:
  1. Meet the diagnostic criteria for diagnosis and treatment of acute pancreatitis in 2013 Chinese guide acute pancreatitis;
  2. According to the diagnostic standard of intra-abdominal hypertension of World Society of the Abdominal Compartment Syndrome;
  3. IAH I level or above;
  4. IAH belong to the bloating, or at the same time, but by puncture drainage fluid after intra-abdominal hypertension and Abdominal compartment syndrome treatment is invalid;
  5. Age 18-70 one full year of life;
  6. Onset of pancreatitis within <=2 weeks;
  7. And signed the informed consent of patients.
  Exclusion Criteria:
  1. Mechanical intestinal obstruction patients;
  2. Neostigmine taboo subjects;
  3. Ming or mannitol allergic patients of neostigmine;
  4. Refused 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: Evaluation of Prognosis With Integrated MRI/PET in Patients With Pancreatic Cancer

Summary: The aim of this study was to evaluate MR/PET with both functional and molecular imaging on the prediction of prognosis in patients with suspected pancreatic cancer.

Detailed description: The results of MR/PET will be compared prospectively to dedicated MDCT or MR imaging, pathologic results, and clinical outcomes to assess the value of MR/PET in pancreatic cancers.

Eligibility: Inclusion Criteria:
  1. Diagnosed as pancreatic cancer
  2. Between 20~90 years old
  3. ECOG 0-2
  4. Normal renal function
  5. Measurable tumor size (>1cm)
  Exclusion Criteria:
  1. Contraindication for MRI exam
  2. Claustrophobia
  3. Renal insufficiency
  4. Other malignancy
  5. Pregnancy and lactating women

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

Clinical trial: Treatment of Pancreatic Cancer With Abraxane

Summary: This observational program collects data on tolerability, safety and efficacy regarding the use of Abraxane in metastatic pancreatic cancer patients in the daily clinical routine. Additionally data on dosage that is actually used in these patients will be collected. Patients who have pancreatic cancer and additional diseases can be documented in this study, too. Collected data might generate learnings on the optimal use of Abraxane in the daily routine setting.

Detailed description: This observational program is aimed at gaining tolerability, safety and efficacy data with the routine use of Abraxane in its labeled indication in metastatic pancreatic cancer. Additionally data on real life dosing in daily clinical routine will be analyzed.
  A detailed record of the medical history including co-morbidities and pre-treatment regimens will allow analysis of the impact thereof on tolerability, dosage and efficacy.
  Hands-on experience with nab-paclitaxel is very limited in Austria and an non-interventional study could enhance knowledge on optimal drug handling and Adverse Event management.

Eligibility: Inclusion Criteria:
  1. Metastatic pancreatic carcinoma
  2. Age > 18 years
  3. Signed Informed Consent
  4. Normal hepatic, renal and Bone Marrow functions
  Exclusion Criteria:
  1. Pregnant and lactating females 2. Previous treatment for metastatic pancreatic disease 3. Known hypersensitivity to nab-paclitaxel 4. Neutrophils < 1,5 x 10^9/L

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 Multi-center 12-week Study of HMS5552 in T2DM

Summary: This study evaluates the safety, tolerability, efficacy and population PK of HMS5552 in type 2 diabetic adult subjects,there will be 5 groups ,4 groups will receive HMS5552,while 1 will receive placebo.

Detailed description: Glucokinase (GK, also called hexokinase IV or D) can phosphosphorylate glucose to glucose-6-phosphate (G-6-P) in pancreatic β-cells and liver cells, which represents the first step of glucose metabolism. GK also acts as a glucose sensor and exerts a key role in maintaining glucose homeostasis. HMS5552 is a 4th-generation GK agonist or activator (GKA), which was originally licensed from Roche and subsequently developed by Hua Medicine. HMS5552 has been shown to activate GK in pancreatic beta cells, liver and intestinal epithelial cells. It regulates systemic blood glucose through a variety of mechanisms including directly enhancing insulin release (pancreas), inhibiting production of endogenous glucose (liver) and by indirectly promoting GLP-1 release (enteroendocrine L-cells).

Eligibility: Inclusion Criteria:
  1. Male & female, 40~75 years old
  2. T2DM patients，anti-hyperglycemic drug-naïve and on diet & exercise for at least 3 months, or with glucose controlled by Metformin or α-glucosidase inhibitor alone
  3. HbA1c 7.5~10.5% at screening and pre-randomization
  4. Fasting plasma glucose (FPG)7.0~11.1mM (local lab) at screening, and 7.0~13.3mM (central lab) at pre-randomization
  5. BMI: 19~30kg/m2 & TG<5.5mM
  Exclusion Criteria:
  1. T1D，secondary DM, pre-DM
  2. kidney diseases or eGFR MDRD<60ml/min/1.73m2
  3. unstable CVDs，
  4. liver diseases，
  5. mental or CNS diseases，

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 of Capecitabine (Xeloda) in Participants With Locally Advanced or Metastatic Pancreatic Cancer

Summary: This study will evaluate the efficacy and safety of oral capecitabine plus intravenous (IV) gemcitabine in participants with locally advanced or metastatic pancreatic cancer. The anticipated time on study treatment is 3 to 12 months, and the target sample size is 56 individuals.


Eligibility: Inclusion Criteria:
  -  Adult participants 18 to 75 years of age
  -  Locally advanced or metastatic pancreatic cancer
  Exclusion Criteria:
  - Prior chemotherapy for pancreatic cancer

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

Clinical trial: Effects of Sucralose on Glucose Metabolism

Summary: In this study the effects of sucralose on insulin sensitivity, beta-cell response and appetite regulating hormones will be evaluated.

Detailed description: The consumption of non-nutritive sweeteners has a high prevalence. The effect of non-nutritive sweeteners in both beta-cell function and insulin resistance it is unknown.
  Previous studies performed in animal models and humans with diverse characteristics have shown variable effects of different non-nutritive sweeteners in variables related to glucose metabolism.
  Due to the high consumption of non-nutritive sweeteners it is relevant to know its effect in beta cell-function and insulin sensitivity.
  In this study the effects of sucralose, a non-nutritive sweetener that is highly consumed in the population, on insulin sensitivity and beta-cell function will be evaluated.
  54 participants with normal glucose tolerance, normal weight, and without chronic diseases with a low consumption of non-nutritive sweeteners will be included. The participants will be randomly assigned to consume sucralose or to a control group.
  During the first visit an oral glucose tolerance test with 75 g of glucose will be performed. Fasting and 2-hour glucose will be measured in order to rule-out diabetes, abnormal fasting glucose, or glucose intolerance.
  During the second visit a three-hour IV glucose tolerance test will be performed administering 0.3 g/kg of glucose and insulin 0.03 U/kg. Samples will be taken following the minimal model described by Bergman.
  After this visit, the group assigned to receive sucralose will ingest 15% of the adequate daily intake (ADI) of sucralose and the control group will abstain of any non-nutritive sweetener consumption during 14 days. At the end of this period a third visit to repeat the IV glucose tolerance test will be performed.
  Samples will be analyzed measuring glucose and insulin concentrations to evaluate acute insulin response (AIR), glucose effectiveness (SG), first phase pancreatic response (ф1), and second phase pancreatic response (ф2). In addition, hormones involved in appetite and satiety (leptin, ghrelin, and peptide tyrosine tyrosine) will be quantified at the beginning and end of the intervention.

Eligibility: Inclusion Criteria:
  -  both genders
  -  age between 18 and 55 years
  -  body mass index ≥18.5 and <25 kg/m2
  -  low consumption of non-nutritive sweeteners
  Exclusion Criteria:
  -  diabetes or glucose intolerance
  -  consumption of medications affecting insulin sensitivity (metformin, steroids, hormone replacement therapy, contraceptives)
  -  intestinal disease such as malabsorption or previous intestinal resection
  -  history of bariatric surgery
  -  pregnancy or lactation
  -  weight loss greater than 5% in the previous month

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, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)

Summary: Protocol ALCT-0000497 is a multicenter safety, tolerability and fat absorption study that anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic fibrosis. Subjects with confirmed exocrine pancreatic insufficiency will use a novel enteral feeding in-line digestive enzyme cartridge (RELiZORB) connected to enteral pump sets.

Detailed description: Protocol ALCT-0000497 consists of three distinct study periods as follows:
  1. In Period A (7 days), subjects will receive Peptamen 1.5 enteral feedings at home.
  2. In Period B (11 days), subjects will be randomized to either Group A (active investigational then placebo control) or Group B (placebo control then active investigational) and receive Impact Peptide 1.5 on Days 1 and 9. During the 8-day washout period between Days 1 and 9, subjects will receive Peptamen 1.5.
  3. In Period C (9 days), subjects will use RELiZORB during nocturnal enteral feedings with Impact Peptide 1.5.

Eligibility: Inclusion Criteria:
  1. Confirmed CF diagnosis with 2 clinical features
  2. Documented history of EPI
  3. Enteral formula use minimum of 4x/week
  4. Written informed consent or assent, as applicable
  Exclusion Criteria:
  1. Uncontrolled diabetes mellitus
  2. Signs and symptoms of liver cirrhosis or portal hypertension
  3. Lung/liver transplant
  4. Active cancer currently receiving cancer treatment
  5. Crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerant, inflammatory bowel disease
  6. DIOS or fibrosing colonopathy

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 Clinical Trial Analyzing Effects of Prokinetic Drug on the Blood Glucose in Patients With Type 2 Diabetes

Summary: With the improvement of living level, the incidence rates of diabetes, obesity, and hypertension in China increased quickly, which are 11.6%, 7.1% and 18.8% respectively, according to the newly investigated data. The clustering of diabetes, obesity, hypertension and dyslipidemia increases the risk of cardiovascular events for patients. GLP-1 (glucagon like peptide-1) is a kind of incretin discovered in recent years. It was reported that beside its hypoglycemic and losing weight effects, activator of GLP-1 receptor could decrease blood pressure and improve lipid metabolism. Sleeve gastrectomy can improve the level of blood glucose and serum lipid of type 2 diabetic rats by ameliorate insulin level and insulin resistance, which may be related with the change of gastrointestinal hormones such as ghrelin and GLP-1. So, intervention of gastrointestinal tract and gastrointestinal hormone secretion may be a new therapy for glycolipids disorder and vascular complications. But, it is lack of evidence-based medicine proof on the relationship between prokinetic drug and glycolipids metabolism. So, the investigators designed a prospective, randomized, double-blinded, placebo control study, and try to evaluate the effects of prokinetic drug (Mosapride) on the blood glucose and serum lipid in type 2 diabetic patients.


Eligibility: Inclusion Criteria:
  -  Male or female, age between 30-65 years old
  -  Type 2 diabetes
  -  Duration of diabetes less than 5 years and pancreatic function be in compensated stage.
  -  7%≤HbA1C≤9%
  -  Patients are able to control diet and exercise by themselves in intervention period.
  Exclusion Criteria:
  -  Type 2 diabetes with serious complications, such as diabetic neuropathy, diabetic retinopathy, stage IV diabetic nephropathy, or acute diabetic complications.
  -  Type 2 diabetes using insulin, GLP-1 analogues or DPP-IV inhibitors).
  -  Heart function in NYHA Grade II-IV or history of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months.
  -  Hypohepatia (AST or ALT is two times higher than the upper limit) or history of cirrhosis, hepatic encephalopathy, esophageal varices or portal shunt.
  -  Renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
  -  Chronic obstructive pulmonary disease (COPD), chronic respiratory failure or hyoxemia.
  -  Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
  -  Fertile woman without contraceptives.
  -  Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
  -  Allergic to or have contraindication to the intervention drugs.

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

Clinical trial: Pancreatic Neuroendocrine Tumor：Factor of Surgery Influencing Survival

Summary: Investigator determined the factor of surgery associated with the survival of pancreatic neuroendocrine tumor.

Detailed description: The variables including clinical characteristics, surgical data and pathological findings are examined by univariate and multivariate analyses.

Eligibility: Inclusion Criteria:
  -  The patients with pancreatic neuroendocrine tumor underwent pancreatectomy
  Exclusion Criteria:
  -  The patients with pancreatic neuroendocrine tumor did not undergo pancreatectomy

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

Clinical trial: Quality of Life After Radiofrequency Ablation of Pancreatic Cancer

Summary: A prospective clinical study evaluating quality of life (QoL) in pancreatic cancer patients treated with intraoperative radiofrequency ablation (RFA).


Eligibility: Inclusion Criteria:
  -  histologically proved locally advanced or metastatic pancreatic cancer. Patients with histologically proved resectable pancreatic cancer with low Karnofsky index.
  informed consent
  Exclusion Criteria:
  -  cystic tumor
  age under 18

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 With CY, Pembrolizumab, GVAX, and SBRT in Patients With Locally Advanced Pancreatic Cancer

Summary: This study will be looking at whether combining cyclophosphamide, pembrolizumab (an antibody that blocks negative signals to T cells), GVAX (pancreatic cancer vaccine), and SBRT (focused radiation) is effective (anti-tumor activity) and safe in patients with locally advanced pancreatic cancer.


Eligibility: Inclusion Criteria:
  1. locally advanced pancreatic adenocarcinoma
  2. Patients must have received mFOLFIRINOX or Gemcitabine/ Abraxane based chemotherapy for 4 cycles with last dose of therapy between 2-5 weeks of study enrollment.
  3. No metastatic disease
  4. ECOG Performance Status of 0 to 1
  5. Adequate organ function as defined by study-specified laboratory tests
  6. Patients must be able to have fiducials placed for SBRT
  7. Must use acceptable form of birth control through the study
  8. Signed informed consent form
  9. Willing and able to comply with study procedures
  Exclusion Criteria:
  1. Patients who have been off of mFOLFIRINOX or gemcitabine/abraxane therapy for more than 49 days
  2. Patients who have had more than one line of chemotherapy
  3. Patients with uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements
  4. Patient who have had prior treatment with IL-2, interferon, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, or anti-CTLA-4 antibodies
  5. Patients receiving active immunosuppressive agents or chronic use of systemic corticosteroids within 14 days prior to first dose of study drug
  6. Patients who have received growth factors, including but not limited to granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 14 days of study drug administration
  7. Patients with history of any autoimmune disease:inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematous (SLE) autoimmune vasculitis, CNS or motor neuropathy considered to be of autoimmune origin.
  8. Patients who have known history of infection with HIV, hepatitis B, or hepatitis C
  9. Patients with evidence of interstitial lung disease
  10. Patients on home oxygen
  11. Patients with oxygen saturation of <92% on room air by pulse oximetry
  12. Pregnant or lactating
  13. Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures

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 Pancreatic Steatosis in Patients With Cancer of Pancreas

Summary: Prognostic Importance of Quantitative Magnetic Resonance Imaging for Evaluation of Pancreatic Steatosis in Patients with Pancreatic Cancer

Detailed description: 1. Finding patients with pancreatic cancer (in all stages), before any treatment.
  2. Non invasively quantify fatty infiltration of pancreas using, MRI DIXON Scan in pancreatic cancer patient relatively to liver.
  3. Measuring cell-free blood DNA in those patients for evaluating the aggressiveness of the disease.
  4. Quantify the prognostic significance of pancreatic steatosis in comparison with clinical and pathological prognostic indexes used today.

Eligibility: Inclusion Criteria:
  -  patients diagnosed with any pancreatic cancer, in any stage, before treatment.
  -  >18 y.o
  Exclusion Criteria:
  -  claustrophobia
  -  GFR<30
  -  patients with non mri compatible devices (e.g. orthopaedic external fixation system)
  -  After chemotherapy treatment or surgical 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: Observational Study on Quality of Life of Patients Receiving Nab-paclitaxel/Gemcitabine First Line Therapy, Including a Translational Program

Summary: Current studies resulted in a superiority of a combination of nab-paclitaxel and gemcitabine vs. gemcitabine mono therapy, but no data are available yet on the quality of life (QoL) under this combination therapy. In the framework of a German multicenter prospective, observational study ('QoliXane'), detailed QoL-data are now collected. QoL development under treatment will be analyzed and data will be compared to existing data of the gemcitabine mono therapy.
  QoL and course of therapy are collected using the EORTC C30 questionnaires once a month over a 6-month period. Additionally patients are requested to answer a supplementary questionnaire addressing e.g. fears related to QoL deterioration and side effects of chemotherapy. Primary endpoint is the proportion of patients with maintained Global Health Status/QoL at 3 months (10 points threshold). 600 patients shall be enrolled at about 90 study sites in Germany.


Eligibility: Inclusion Criteria:
  -  metastatic pancreatic carcinoma
  -  no previous therapy in the metastatic stage
  -  planned firstline therapy with nab-paclitaxel and gemcitabine
  Exclusion Criteria:
  -  previous therapy in the metastatic stage
  -  patient unable to understand the study and to give informed consent
  -  patient unable to answer quality of life questionnaires

Relevance to patient case: not relevant