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

Clinical trial: Phase I Study Evaluating the Treatment of Patients With Locally Advanced Pancreatic Cancer With Carbon Ion Radiotherapy: The PHOENIX-01 Trial

Summary: The physical and biological properties of the carbon ion beam promise to improve the therapeutic ratio in patients with pancreatic cancer: Due to the inverted dose profile dose deposition in the entry channel of the beam leads to sparing of normal tissue; the Bragg peak can be directed into the defined target volume, and the sharp dose fall-off thereafter again spares normal tissue behind the target volume. The higher RBE of carbon ions, which has been shown also for pancreatic cancer cell lines in the preclinical setting, is likely to contribute to an increase in local control, and perhaps in OS. Early data from Japanese centers have shown convincing results. The PHOENIX-01 trial is the first trial to evaluate actively delivered carbon ion beams in patients with locally advanced pancreatic cancer within a dose-escalation strategy.


Eligibility: Inclusion criteria
  Patients meeting all of the following criteria will be considered for admission to the trial:
  -  histologically confirmed locally advanced pancreatic cancer or imaging defined pancreatic cancer combined with elevated CA-19-9
  -  macroscopic tumor after biopsy
  -  age ≥ 18 years of age
  -  Karnofsky Performance Score >=60
  -  For women with childbearing potential, (and men) adequate contraception (sexual abstinence, estrogen- or gestagen containing contraceptive medication etc.)
  -  Female participants: No pregnancy present (pregnancy test required)
  -  Ability of subject to understand character and individual consequences of the clinical trial
  -  Written informed consent (must be available before enrolment in the trial)
  Exclusion criteria:
  Patients presenting with any of the following criteria will not be included in the trial:
  -  distant metastases
  -  refusal of the patients to take part in the study
  -  previous radiotherapy of the abdomen
  -  Patients who have not yet recovered from acute toxicities of prior therapies
  -  Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
  -  Pregnant or lactating women
  -  Participation in another clinical study or observation period of competing trials, respectively

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 Intratumoral Gemcitabine in Locally Advanced Unresectable Pancreatic Cancer

Summary: Pancreatic cancer is the 11th most common type of cancer but it is the fourth leading cause of cancer death. The only effective treatment for pancreatic cancer includes surgery. However, only 20% of the patients have surgically treatable disease. Also, the 5-year survival for the surgically treated patients is only 15%.
  About 40% of the patients present with advanced disease with distant metastasis, and the remaining 40% present with locally advanced unresectable cancer with the tumor invaded into surrounding major vessels. For those with locally advanced disease, systemic chemotherapy with or without radiotherapy provides palliation of the symptoms but cannot cure the disorder. Systemic chemotherapy is given through peripheral vessels.
  The investigators hypothesized that direct injection of the chemotherapeutic drug into the tumor may help to boost the effect of systemic chemotherapy and radiotherapy in those with locally advanced pancreatic cancer.

Detailed description: In this study, gemcitabine will be injected directly into the tumor by means of endoscopic ultrasound (EUS) in the eligible patients.

Eligibility: Inclusion Criteria:
  -  Patients with histologically verified pancreatic adenocarcinoma who have locally advanced unresectable tumor
  Exclusion Criteria:
  -  Early stage resectable pancreatic cancer with the intact surrounding major vessels on imaging
  -  Pancreatic cancer with distant metastasis
  -  Unwilling to sign 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: Chemoimmunotherapy and Radiation in Pancreatic Cancer

Summary: The goal of this study is to evaluate the safety of combination treatment that includes chemotherapy, radiation therapy, and immunotherapy in patients with pancreatic cancer.

Detailed description: This study is for borderline resectable and advanced pancreatic cancer patients. Patients will receive chemotherapy with gemcitabine and immunotherapy with daily tadalafil during the first 21 days of treatment. On study day 22, patients will receive the first of three planned doses of radiation therapy and continue daily tadalafil. Patients are then evaluated to determine if they are candidates for pancreaticoduodenectomy. Patients who are not candidates will continue daily tadalafil and receive gemcitabine chemotherapy. Patients who have surgery will resume daily tadalafil and gemcitabine chemotherapy following recovery from surgery. Patients will receive up to four cycles of gemcitabine.

Eligibility: Inclusion Criteria:
  -  Pancreatic adenocarcinoma
  -  Locally advanced unresectable disease, or borderline resectable disease
  -  ECOG (Eastern Cooperative Oncology Group)Performance Status 0 or 1
  -  Ability to provide consent and comply with study protocol
  -  Women of child-bearing potential must have a negative pregnancy test and avoid pregnancy during the study
  Exclusion Criteria:
  -  Age < 18
  -  History of other malignancy in previous 2 years except carcinoma in situ of the cervix or bladder, or non-melanoma skin cancer
  -  Previous chemotherapy or radiation therapy for pancreatic cancer or previous radiation to the target field
  -  Clinically active autoimmune disease or active infection
  -  History of heart attack within 90 days or stroke within 6 months, hypertension requiring change in blood pressure medications in the last 4 weeks, hypotension, uncontrolled arrhythmias, heart failure (NYHA >= Class 2 in last 6 months), unstable angina, or angina during sexual activity
  -  Use of nitrates or nitroglycerin
  -  History of hereditary degenerative retinal disorders including retinitis pigmentosa
  -  Chronic systemic corticosteroid use at supra-physiologic doses
  -  Use of recreational drugs called 'poppers' like amyl nitrite and butyl nitrite
  -  Blood test results (neutrophils < 1000 /uL (microliter); hemoglobin < 9 gm /dL; platelet count < 1000 cells / uL; significant coagulopathy; significant liver or renal dysfunction

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 Phase I Study of Veliparib (ABT-888) in Combination With Gemcitabine and Intensity Modulated Radiation Therapy in Patients With Locally Advanced, Unresectable Pancreatic Cancer

Summary: This is a Phase I Study of veliparib (ABT-888) in combination with Gemcitabine and Intensity Modulated Radiation Therapy in Patients with Locally Advanced, Unresectable Pancreatic Cancer.
  Primary Objectives:
  -  Determine the maximum tolerable dose of veliparib in combination with gemcitabine and intensity modulated radiation therapy in patients with locally advanced pancreatic cancer.
  -  Determine the safety and toxicity of the combination of veliparib with gemcitabine and radiation therapy in patients with locally advanced pancreatic cancer

Detailed description: Gemcitabine will be administered by intravenous infusion of 1000 mg/m2 over 30 minutes on days 1, 8, 15 of the cycle. Intensity modulated radiation therapy (IMRT) will be given to a total dose of 36 Gy in 15 fractions (2.4 Gy per fraction, one fraction per day, 5 fractions per week, Monday through Friday) beginning on day 1. Veliparib will be administered per a dose escalation schema. The starting dose of veliparib is 20 mg BID based upon safety/efficacy data available. Dose escalation will continue in 20 mg increments until the maximum tolerated dose (MTD) is reached. Intra-patient dose escalation will not be allowed.

Eligibility: Inclusion Criteria:
  -  Patients with histopathological or cytological diagnosis of adenocarcinoma of the pancreas, as well as those with high clinical suspicion of adenocarcinoma, which is deemed locally advanced unresectable or borderline resectable as determined by a pancreatic cancer surgeon and/or following evaluation by a GI oncology tumor board.
  -  Age 18 years or older
  Exclusion Criteria:
  -  Patients who have had prior anti-cancer treatment for their disease
  -  Patients who are currently receiving any other investigational agents
  -  Metastatic disease
  -  History of allergic reactions attributed to compounds of similar chemical or biologic composition to PARP [Poly (ADP-ribosome) polymerase] inhibitors or gemcitabine
  -  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

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

Clinical trial: Magnetic Resonance Imaging Study of Acute Pancreatitis

Summary: To quantitatively analyze the T2* values of the head, body, and tail of normal pancreas, and observe the value of GRE T2*-weighted MRI in the diagnosis of acute pancreatitis and the relationship between the T2* value and the severity of AP.

Detailed description: 1. We design a prospective study about "Magetic Resonance Imaging Study of Acute Pancreatitis".
  2. We apply for an account and register our study on the clinicalTrials.
  3. In patients with acute pancreatitis, imaging is recommended to confirm the clinical diagnosis, investigate the etiology, and grade the severity of the disease . MR had the excellent resolution of soft tissue，and it has earned an ever more important role in the diagnosis of AP. With the continuous development of MR scanning techniques, the sequence of a multi-echo gradient recalled echo (GRE) T2*-weighted imaging (T2*WI), which acquires a spin echo signal, T2* relaxation acquires a gradient echo signal, is a relatively new MRI technique. The sequence of a GRE T2*WI requires high uniformity of the magnetic field, plus it can provide the T2* value, which can indirectly reflect changes in tissue biochemical components, thus it can be used for the early diagnosis quantitative diagnosis of some diseases .
  4. This calculation process for T2* value is completed using post-processing software on the workstation(Advantage workstation 4.4; GE Halthcare) directly after scanning.
  5. AP is a process of inflammation diffusion, in which cell edema will lead to hydrogen proton increase. In the inflammatory exudation process, T2* value will change. So we conduct our research. In this study, we will observe pancreas in the normal pancreas and AP, and discuss the relationship between T2* value and that of AP graded by the MR severity index (MRSI) and Acute Physiology And Chronic Healthy Evaluation II (APACHE II) scores.
  6. However, until now, there is no research on the sequence applied in the patients with AP.

Eligibility: Inclusion Criteria:
  -  acute onset of abdominal pain;
  -  pancreatitis at first onset;
  -  three-fold elevated amylase or lipase, excluding other causes of elevated enzymes; and
  -  abdominal MR examination.
  Exclusion Criteria:
  -  inability to cooperate when MR imaging was performed;
  -  a history of chronic pancreatitis;
  -  AP due to pancreatic carcinoma;
  -  hypoproteinemia;
  -  with hypoproteinemia and other peritoneal/ retroperitoneal infection diseases ;
  -  with iron deposition disorder (e.g. diabetes or blood system 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: Analgesia and Pancreatic Cancer Surgery

Summary: Long-term survival for patients with pancreatic carcinoma is low, even following resection, the 5-year survival rate of patients ranges from 10 to 25%1. Most treatment failure is due to local recurrence, distant metastasis or both within one to two years after surgery2-4.
  Surgery has been suggested to accelerate the development of preexisting micro metastases and to promote the establishment of new metastases5. Release of catecholamine and proinflammatory products secondary to surgical stress is believed to promote cancer progression6. Maintenance of proper anesthetic depth is beneficial to attenuate surgical stress. However, general anesthesia including numerous induction agents, volatile anesthetics and opioids, is associated with immunosuppression especially on the cell-mediated immunity which has a crucial role in prevention of micrometastasis5,7. Therefore, regional anesthesia and analgesia which effectively attenuating surgical stress while efficiently reducing general anesthetics consumption, seem to provide promising advantages to prevent perioperative cancer progression. Currently, most studies available in humans are retrospective and observational to evaluate regional anesthesia and prostate, colorectal, breast and cervical cancer-related outcomes8-12. Only one randomized study investigating major abdominal cancer surgery is available13. However, it is not specific to an individual cancer type and perioperative cell-mediated immunity is not evaluated.
  In this study, we aimed to identify whether epidural block beneficial to early surgical and late cancer-related outcomes in patients receiving pancreatic cancer surgery. Perioperative cell-mediated immunity functions including natural killer cells, helper and cytotoxic T-lymphocytes were also investigated.


Eligibility: Inclusion Criteria:
  -  Pancreatic cancer expected to receive curative Whipple operation
  Exclusion Criteria:
  -  palliative operation
  -  preoperative chemotherapy or radiotherapy
  -  patients with metastasis
  -  contraindications for epidural catheter placement
  -  prior spine surgery

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 the Effectiveness and Safety of SP2086 to Treat Type 2 Diabetes

Summary: SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to explore the effective dose range of SP2086 in Patients with type 2 diabetes.


Eligibility: Inclusion Criteria:
  -  20 Years to 70 Years ,Male and Female diagnosed with type 2 diabetes mellitus
  -  Patients not on an oral antihyperglycemic agent (OHA) with 7.0% ≤HbA1C ≤10.5%,or not on an OHA for 3 months with 7.0% ≤HbA1C ≤10.5%
  -  BMI 19~35 kg/m2
  Exclusion Criteria:
  -  Patient has history of type 1 diabetes mellitus
  -  Patient has history of ketoacidosis
  -  Patient has history of severe unconscious hypoglycemosis
  -  Patient has history of acute and chronic pancreatitis or pancreatic injury that may lead to high risk of pancreatitis
  -  Patient has history of decompensated heart failure (NYHA class III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, persistence and clinical
  -  Patient has history of a history of hypertension, and after antihypertensive treatment, systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg
  -  Patient has severe liver or kidney disease,alanine aminotransferase >2×UNL, Aspartate Aminotransferase >2×upper normal limit(UNL)；total bilirubin >2×UNL； creatinine>1.5 mg/dL (Male,132.6μmol/L) ，>1.4 mg/dL(Female，123.8μmol/L)
  -  Patient has severe chronic gastrointestinal disease or therapy that may affect drug absorption, such as gastrointestinal surgery
  -  Patient has severe haematological diseases or other diseases leading to hemolyze and red blood cell unstable (malaria、haemolytic anaemia eg. )
  -  Patient has other endocrine diseases, for example hyperthyroidism、hypothyroidism、hypercortisolism、multiple endocrine neoplasia and so on
  -  Patient has history of malignancy
  -  Patient has history of alcohol or drug abuse

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

Clinical trial: Efficacy and Safety of SP2086 as Monotherapy in Patients With Type 2 Diabetes

Summary: SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to evaluate the efficacy and safety of SP2086 as monotherapy in patients with Type 2 Diabetes Mellitus in Metformin monotherapy Who Have Inadequate Glycemic Control treated with diet and exercise for 3 months


Eligibility: Inclusion Criteria:
  -  Patients diagnosed with type 2 diabetes mellitus
  -  Patients have treated with diet/exercise at least 3 months
  -  7.5% ≤HbA1C ≤11.0% at screening,7.0% ≤HbA1C ≤10.5% after run-in
  Exclusion Criteria:
  -  Patient has history of type 1 diabetes mellitus
  -  Patient has history of ketoacidosis
  -  Patient has history of severe unconscious hypoglycemosis
  -  Patient has history of acute and chronic pancreatitis or pancreatic injury that may lead to high risk of pancreatitis
  -  Patient has history of decompensated heart failure (NYHA class III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, persistence and clinical
  -  Patient has history of a history of hypertension, and after antihypertensive treatment, systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg
  -  Patient has severe liver or kidney disease,alanine aminotransferase >2×UNL, Aspartate Aminotransferase >2×upper normal limit(UNL)；total bilirubin >2×UNL； creatinine>1.5 mg/dL (Male,132.6μmol/L) ，>1.4 mg/dL(Female，123.8μmol/L)
  -  Patient has severe chronic gastrointestinal disease or therapy that may affect drug absorption, such as gastrointestinal surgery
  -  Patient has severe haematological diseases or other diseases leading to hemolyze and red blood cell unstable (malaria、haemolytic anaemia eg. )
  -  Patient has other endocrine diseases, for example hyperthyroidism、hypothyroidism、hypercortisolism、multiple endocrine neoplasia and so on
  -  Patient has history of malignancy
  -  Patient has history of alcohol or drug abuse

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 Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.

Summary: In Brazil pancreatic adenocarcinoma represents 2% of tumors, and 4% mortality being an uncommon disease, however very aggressive.Only 20% of cases are indicated for curative surgery, of which only 20% are alive within 5 years. For locally, advanced or metastatic disease, since 1997, single chemotherapy with gemcitabine is the standard treatment for first line, with survival around 6 months approximately.There is no standard treatment regimen for second-line, however Paclitaxel demonstrated effect on second-line phase II study. Metformin is an oral hypoglycemic drug used for treatment of diabetes mellitus. There is a growing number of preclinical studies which show antitumor effect against pancreatic adenocarcinoma, probably due to the effect of anti-insulin growth factor (IGF-1). This study will add metformin to standard treatment for second line of locally advanced or metastatic pancreatic adenocarcinoma in ICESP previously treated with gemcitabine. The objective is to evaluate whether metformin improves the efficacy of the standard treatment with paclitaxel by clinical and radiological evaluation.


Eligibility: Inclusion Criteria:
  -  Pancreatic advanced or metastatic adenocarcinoma histologically confirmed.
  -  Previously treatment with gemcitabine as adjuvant or metastatic disease.
  -  Clinical or radiological evidence of disease progression, determined by physician. Is not mandatory RECIST (Response Evaluation Criteria in Solid Tumors) evaluation to determine the progression of disease before the study inclusion.
  -  Patient with intolerance to gemcitabine, even without disease progression, are also eligible.
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
  -  At least 10 weeks of life expectation.
  -  Adequate organ function defined as:
  -  Serum AST (aspartate aminotransferase) and ALT (alanine aminotransferase)≤ 2.5 × ULN (upper normal limit)
  -  Total Bilirubin ≤ 2,0 x ULN
  -  Absolute neutrophil count ≥ 1,500/ mm3
  -  Platelets ≥100.000/ mm3
  -  Hemoglobin ≥ 8,0 g/dl
  -  Serum Creatinine ≤ 1,5 ULN and clearance of creatinine estimated (Cockcroft- Gault) ≥ 50 ml/min
  -  Signed written informed consent.
  Exclusion Criteria:
  -  Major surgical procedure within 4 weeks of the beginning of the treatment.
  -  History of serious clinical or psychiatric disease.
  -  Symptomatic hypoglycemia at the screening visit.
  -  Target lesion radiotherapy within 4 weeks of the beginning of the treatment.
  -  Treatment with any anti-cancer investigational drug.
  -  Treatment with any IGF-I or IGFR-I
  -  Treatment with metformin within 12 months prior to commencing study treatment
  -  For female patients, current pregnancy and/or lactation

Relevance to patient case: not relevant