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

Clinical trial: Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer

Summary: The purpose of this study is to evaluate the efficacy and safety of stereotactic radiation therapy given in five fractions (30 Gray in 5 fractions) followed by gemcitabine in patients with locally advanced pancreatic cancer.

Detailed description: The purpose of this phase I/II study is to evaluate the efficacy and toxicity of a different stereotactic body radiation therapy regimen combined with gemcitabine. In the present study, 5 daily fractions of 6 Gray will be given over two weeks. Stereotactic body radiation therapy will be given with the Cyberknife system. This treatment technique allows to give a higher dose to the tumor as compared to conventional external beam radiation while lowering the dose to the normal tissues around. This treatment system is also capable of following the motion that the pancreas assumes during respiration as well as during treatment. This enables us to reduce the margin of security and further reduce dose to surrounding normal tissue.
  The primary objective of this study is to evaluate acute and chronic toxicity of this regimen of stereotactic radiation therapy followed by gemcitabine. Quality of life, local control and overall survival will also be evaluated.

Eligibility: Inclusion Criteria:
  -  Pancreatic Adenocarcinoma, histologically and/or cytologically proven
  -  Locally advanced pancreatic cancer, surgically non resectable
  -  No distant metastasis
  -  Work-up including medical history, physical exam, biochemistry, chest X-ray, CT-scan of abdomen and pelvis
  -  ECOG performance status : ≤ 2
  -  Primary tumor visible on CT-scan
  -  Maximum tumor diameter of 6 cm (including primary tumor and regional lymph nodes)
  -  White blood cell count > 3000 /uL, Neutrophils > 1500 /uL, Platelets > 100 000/uL, Hemoglobin > 95 mg/L, Total bilirubin < 1,5 normal limit, AST/ALT < 2,5 normal limit, normal creatinin
  -  ≥ 18 years of age
  -  Signed informed consent
  Exclusion Criteria:
  -  Prior abdominal radiation therapy
  -  Connective tissue disease (scleroderma, lupus)
  -  Prior treatment for pancreatic cancer such as radiation therapy, chemotherapy or 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: Study of the P16 Gene as a Predictor of Myelosuppression in Breast Cancer Patients

Summary: The primary purpose of this study is to measure the association between baseline expression of the senescence effector protein p16INK4a and myelosuppression due to chemotherapy in patients with breast cancer. Patients with Stage I-IV breast cancer will be included and myelosuppression will be assessed after the first cycle of chemotherapy via measurement of an absolute neutrophil count (ANC) measured one time between days 7-11 post cycle one. Study subjects will also be asked to complete a brief health behaviors questionnaire to gather information on other relevant variables.


Eligibility: Inclusion Criteria:
  -  ≥ 18 years of age;
  -  Histologically confirmed Stage I-IV breast cancer;
  -  ECOG Performance Status 0-3;
  -  Scheduled to start a new course of chemotherapy in the neo-adjuvant, adjuvant or metastatic setting for newly diagnosed or recurrent disease;
  -  Growth factors, e.g., filgrastim, pegfilgrastim, are allowed, but their dose and duration will be tracked.
  -  Absolute Lymphocyte Count (ALC) > 500 cells/μL as determined by routine CBC with differential;
  -  Signed, IRB approved written informed consent.
  Exclusion Criteria:
  -  Presence of acute, active infection;
  -  History of clonal bone marrow disorder (i.e., myelodysplastic or myeloproliferative disorder, acute or chronic leukemia);
  -  Other co-morbid illness which would impair ability to participate in the study;
  -  Concurrent experimental therapy (Note: concurrent biologic therapy IS permitted, provided it is not experimental).
  -  Prior or current receipt of histone deacetylase (HDAC) inhibitors

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

Clinical trial: L-CARnitine in the Palliative Treatment of Advanced PANcreatic Cancer (CARPAN)

Summary: The study investigated the role of L-Carnitine supplementation on proinflammatory immune response, malnutrition, cancer cachexia and cancer related fatigue in advanced and inoperable pancreatic cancer, UICC Stage IV .

Detailed description: Pancreatic cancer has the lowest 5-year survival rate of any cancer and ranks as the fourth leading cause of cancer death world wide. Several metabolic changes are present in the whole body in case of cancer so the investigators conducted a placebo controlled, double blinded, randomized, prospective and multicentre study to investigate, whether L-Carnitine supplementation may have an impact on malnutrition, cancer cachexia and cancer related fatigue in advanced pancreatic cancer.
  Study drug: L-Carnitine 4g per day (vers) Placebo Study design: A multi-centre, double blind, and placebo-controlled, randomised, parallel group study
  Patient population: Patients with advanced pancreatic carcinoma Number of patients: Total of 90 patients in two equal groups number of centres: 4 (Greifswald, Magdeburg, Berlin,Heidelberg,all Germany) Duration of dosing: 12 weeks

Eligibility: Inclusion Criteria:
  -  advanced pancreatic cancer (UICC Stage IV)
  -  Karnofsky Index larger than 60
  -  compliance
  -  consent to participate to the study
  Exclusion Criteria:
  -  Child-Pugh classification of liver failure greater than Child B,
  -  a known second malignant tumor
  -  oral or parenteral supplementation with omega-3-fatty acids
  -  treatment with thalidomide or Infliximab
  -  mental or physical disorders

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

Clinical trial: Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma

Summary: This phase II study is to evaluate the efficacy of preoperative chemoradiotherapy with gemcitabine (400mg/m2, weekly) for resectable pancreatic cancer.

Detailed description: The primary objective of this study is to evaluate the complete (R0) resection rate for patients with and resectable pancreatic cancer treated with preoperative chemoradiotherapy and curative surgery. An experimental arm that result a complete resection rate of at least 90% would merit further study. With 90% power to reject that null hypothesis that the true complete resection rate is ≤75% with a type I error level of 5%, evaluable 53 patients are required. Considering the 20% unevaluable patients due to the immediate distant metastasis after treatment7, 8, 17 and 10% follow up loss, a total of 64 eligible patients will be enrolled.

Eligibility: Inclusion Criteria:
  -  Patients with resectable pancreatic adenocarcinoma
  -  Age over 18 years old and younger than 70 year old
  -  Performance status (ECOG scale): 0-1
  -  Adequate organ functions
  -  Hb ≥9.0 g/dl
  -  ANC ≥1,500/mm3
  -  PLT ≥100,000/mm3
  -  Liver function: Total Bilirubin ≤3.0 mg/dl AST/ALT/ALP ≤3× upper limit of normal
  -  Creatinine ≤1.5 ULN
  -  Patients should sign a written informed consent before study entry.
  Exclusion Criteria:
  -  Tumor type other than adenocarcinoma
  -  Unresectable for resection on preoperative evaluation
  -  Other primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
  -  Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy)
  -  Prior radiotherapy
  -  Major surgery within 4 weeks prior to study treatment
  -  Serious illness or medical conditions, as follows;
  -  congestive heart failure (NYHA class III or IV)
  -  unstable angina or myocardial infarction within the past 6 months,
  -  significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block
  -  uncontrolled hypertension
  -  hepatic cirrhosis( ≥ Child class B)
  -  interstitial pneumonia, pulmonary adenomatosis
  -  psychiatric disorder that may interfere with and/or protocol compliance
  -  unstable diabetes mellitus
  -  uncontrolled ascites or pleural effusion
  -  active infection
  -  Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug
  -  Pregnant or lactating woman
  -  Women of child bearing potential not using a contraceptive method
  -  Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
  -  Any patients judged by the investigator to be unfit to participate in the study

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

Clinical trial: Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer

Summary: This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of unresectable pancreatic cancer.

Detailed description: This is a single institution, non-randomized, prospective, phase IV trial of SBRT for unresectable pancreatic cancer.
  Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities.
  Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.

Eligibility: Inclusion Criteria:
  -  Patient age >= 18 years
  -  Performance status of 0-3
  -  Unresectable pancreatic cancer
  -  Maximum tumor diameter < 7.5 cm
  -  Signed study-specific consent form
  Exclusion Criteria:
  -  Maximum tumor diameter > 7.5 cm
  -  Prior radiotherapy to the upper abdomen
  -  Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
  -  Patients with psychiatric or addictive disorder that would preclude obtaining 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: Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients

Summary: This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of the orally administered phosphatidylinositol 3'-kinase (PI3K) inhibitor BKM120 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BKM120 and MEK162.
  Study drugs will be administered once daily orally on a continuous schedule. A treatment cycle is defined as 28 days.


Eligibility: Inclusion Criteria:
  -  Histologically/ cytologically confirmed, advanced non resectable solid tumors
  -  Measurable or non-measurable, but evaluable disease as determined by RECIST
  Exclusion Criteria:
  -  Patients with primary CNS tumor or CNS tumor involvement.
  -  Diabetes mellitus
  -  Unacceptable ocular/retinal conditions

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

Clinical trial: Trial Assessing Roux-en-Y Anastomosis of the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy

Summary: The objective is to clarify Roux-en-Y anastomosis of the pancreatic stump decreases pancreatic fistula following distal pancreatectomy, compared with stapling closure of the pancreatic stump.

Detailed description: The objective of this study was to clarify Roux-en-Y anastomosis of the pancreatic stump prevents pancreatic fistula after distal pancreatectomy (DP) compared to stapling closure of the pancreatic stump in a prospective randomized controlled trail.
  Various methods and technique for treating surgical stump of the remnant pancreas have been reported to reduce pancreatic fistula after DP. However, appropriate surgical stump closure after DP is still controversial.
  The primary endpoint in this trial was defined as the incidence of pancreatic fistula .

Eligibility: Inclusion Criteria:
  1. disease of pancreatic body and tail
  2. PS (ECOG Performance Status Scale):0-1
  3. Age: 20 years or older
  4. distant metastases are not diagnosed preoperatively. Eligible for this clinical study when only distal pancreatectomy contributes to the favorable prognosis even if patients with pancreatic neuroendocrine cancer have the liver metastasis.
  5. Adequate organ functions filled the following criteria within two weeks from enrollment:
  1.White blood cell： >3,500/mm3 or <12,000/mm3 2.Neutrophilic leukocyte >2,000/mm3 3.Platelet>100,000/mm3 4.Hemoglobin > 9.0g/dL 5.Total bilirubin <2.0mg/dL 6.AST and ALT<150IU/L 7.Creatinine <1.5mg/dL 6)Patients who can provide written informed consent
  Exclusion Criteria:
  1. Patients with severe liver cirrhosis or active hepatitis
  2. Patients with respiratory illness that requires oxygen administration
  3. .Patients with chronic renal failure requiring dialysis
  4. Patients with active duplicative malignant disease affecting adverse event
  5. Others, patients who are unfit for the study as determined by the attending physician

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

Clinical trial: 22G FNA Needle vs. 22G ProCore Needle

Summary: The aim of this research study is to identify the best needle for performing biopsy during EUS procedures. There are two types of needles for performing biopsy: A FNA needle that provides a small sample of tissue for analysis and a ProCore needle that provides larger amount of tissue. It is not clear at this point which of the two needles is superior for performing biopsy. This study will attempt to identify the better needle by assessing the performance of both needles in a randomized fashion.

Detailed description: In this randomized trial, the 22G fine needle aspiration needle was compared with the newly developed 22G ProCore needle for sampling pancreatic mass lesions during endoscopic ultrasound. Patients were randomized into the two needle groups and then various outcomes were compared between the two needle types, including the number of passes needed to establish a diagnosis, the ability to procure enough tissue sample to be able to make a diagnosis, the rates of needle failure and complication rates.

Eligibility: Inclusion Criteria:
  -All patients with solid pancreatic mass lesions
  Exclusion Criteria:
  -  Coaguloapthy,
  -  minors,
  -  prgenant patients

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

Clinical trial: Adjuvant Gemcitabine and Cisplatin Followed by Chemoradiation for Resected Pancreatic Cancer

Summary: This is a phase Ⅱ Trial of Postoperative Adjuvant Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiation With Gemcitabine in Patients With Resected Pancreatic Cancer.

Detailed description: The primary study objective is to evaluate recurrence/metastasis free survival at 12 months with postoperative adjuvant treatment incorporating gemcitabine plus cisplatin chemotherapy followed by chemoradiation with gemcitabine followed by maintenance chemotherapy with gemcitabine.

Eligibility: Inclusion Criteria:
  1. Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
  2. Be between 18 and 75 years of age.
  3. Patients who are ambulatory and have a ECOG Performance Status of 0-2.
  4. Histologically confirmed pancreatic adenocarcinoma.
  5. Received curative resection (R0 resection) of stage 1b ~ 2b pancreatic cancer (according to AJCC staging, 6th edition - Appendix 1), no more than 8 weeks has elapsed since the time of operation.
  6. WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3. Platelet count at least 100,000/mm3.
  7. Bilirubin less than 2.0 mg/dL, AST less than 3 times upper limit of normal (ULN).
  Serum creatinine no greater than 1.5 times ULN.
  Exclusion Criteria:
  1. Pregnant or lactating woman.
  2. Woman of childbearing potential with either a positive or no pregnancy test at baseline.
  3. Woman of childbearing potential not using a reliable and appropriate contraceptive method (postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
  4. Sexually active males unwilling to practice contraception during the study.
  5. Prior chemotherapy for the treatment of pancreatic carcinoma.
  6. Radiotherapy incorporating radiation fields of more than 25% of active bone marrow.
  7. History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
  8. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication).
  9. Participation in any investigational drug study within four weeks preceding the start of study treatment.
  10. Serious, uncontrolled, intercurrent infection(s).
  11. Other significant medical conditions that would, in the judgment of the investigator, make administration of study drug unsafe.

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

Clinical trial: Chemotherapy for Patients With Locally Advanced Pancreatic Cancer (LAPC) With Additional Chemo-radiotherapy (CRT) for Patients With Borderline Resectable Tumours

Summary: Treating patients with initial local non-resectable pancreatic cancer with a combination of oxaliplatin, irinotecan & 5-FU(FOLFIRINOX), consolidated with chemoradiotherapy in potentially resectable patients, will result in a high rate of tumor shrinkage allowing subsequent resection in patients with initial borderline resectable tumors and improved overall survival for all patients.

Detailed description: Pancreatic cancer (PC) is the third most common gastrointestinal malignancy and one of the top ten leading causes of cancer deaths in the Western world. Patients with PC can be divided into three subgroups; resectable (rPC), locally advanced (LAPC) and metastatic (mPC). For patients with rPC surgery offers the best chance for long term survival. However it is estimated that only 20% of patients have rPC at the time of diagnosis. For patients with LACP, invasion of local large vessels is most often the cause for non-resectability. The median survival of these patients is between 6 to 12 months and long term survival in is extremely rare. The optimal treatment of LAPC is controversial. Treatment strategies vary between attempts to "downstage" the tumour to rPC, or treat the patients in a palliative setting only. Phase II studies and retrospective series have evaluated various treatments regimens and strategies including chemotherapy and radiotherapy (RT) alone or in combination - chemoradiotherapy (CRT). Results from these trials give no clear answer regarding the best treatment strategy. However, data from several studies shows that treatment of LAPC may result in shrinkage of the tumour, and thus potentially lead to a resection; also data suggests that CRT after chemotherapy improves treatment efficacy. Recent data from patients with mPC has show a combination of oxaliplatin, irinotecan and 5-FU (FOLFIRINOX) increases response rates from 10% to 30% and median survival to 11.1 months. The promising efficacy makes it natural to attempt this treatment in patients with LAPC.

Eligibility: Inclusion Criteria: (major)
  -  non-metastatic pancreatic cancer
  -  Performance status 0-1
  -  Bilirubin < 1.5 UNL
  -  Written informed consent
  Exclusion Criteria: (major)
  -  no prior abdominal radiotherapy
  -  no prior chemotherapy for pancratic cancer
  -  no severe comorbidity
  -  patients must be able to undergo potential abdominal 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: Pancreatic Enzyme Suppletion in Pancreatic Cancer

Summary: This study will evaluate the effect of immediate pancreatic enzyme suppletion on the physical and mental health status and survival of patients who are diagnosed with pancreatic cancer and are highly likely to develop exocrine pancreatic insufficiency during their disease process.

Detailed description: Weight loss in cancer is caused by primary tumour effects and secondary effects (e.g. side effects of treatment, mechanical and intestinal obstruction). In pancreatic cancer, additional weight loss and malnutrition may be due to the development of exocrine pancreatic insufficiency (EPI). The presence of EPI in pancreatic cancer is frequently overlooked, because the focus of treatment is directed at possible surgery or chemotherapy and its potential side effects. Although studies have proven that pancreatic enzymes may prevent or decrease weight loss, they are seldom being prescribed.

Eligibility: Inclusion Criteria:
  -  Adenocarcinoma of the pancreas (histologically confirmed)
  -  Normal exocrine pancreatic function (Fecal Elastase test > 0.2 mg/g)
  -  Capable and willing to follow instructions given by the physician.
  Exclusion Criteria:
  -  Other causes of fat malabsorption (celiac disease, IBD, and major gastrointestinal surgery).
  -  < 18 years.

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 of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)

Summary: The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.


Eligibility: Inclusion Criteria:
  -  Male and female outpatients, of age 18 - 54 years
  -  Patients diagnosed with stage 1 or stage 2 essential hypertension
  -  Normal physical examination findings and electrocardiogram (ECG) results or abnormal findings judged by the Investigator to be not clinically significant
  Exclusion Criteria:
  -  Secondary hypertension or severe hypertension
  -  History of Type 1 diabetes mellitus
  -  A medical contraindication to discontinuing a current antihypertensive therapy
  -  Clinically significant respiratory disease that prohibit use of a beta blocker

Relevance to patient case: not relevant