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

Clinical trial: Pancreatic Cancer Registry: For Any Person With a Personal or Family History

Summary: The NFPTR was established in 1994 to find the causes of pancreatic cancer. In brief, the investigators are interested in both the genetic and non-genetic causes of pancreatic cancer. The investigators are particularly interested in finding the genes that cause pancreatic cancer to cluster in some families. Up to 10% of pancreatic cancer patients have another close relative who has also developed pancreatic cancer. This clustering of pancreatic cancers in families has yet to be explained; however, the investigators continue to identify new familial pancreatic cancer genes that explain this clustering in subsets of families. For example, in 2009 and 2012 the investigators discovered that mutations in the PALB2 and ATM genes jointly account up to 5% of the clustering of pancreatic cancer in families.


Eligibility: Inclusion Criteria:
  -  personal or family history of pancreas tumors
  Exclusion Criteria:

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

Clinical trial: Developing Prehabilitation Program in Patients With Operable Pancreatic Cancer Perioperatively and Following Surgery

Summary: The aims of this three-year study are to:
  1. explore the change of fatigue, nutritional status, quality of life and care needs in patients with operable pancreatic cancer perioperatively and following surgery within 3 months.
  2. develop and evaluate the effect of patient-centered cancer prehabilitation care program on improving fatigue, nutritional status and quality of life (QOL) in this population.

Detailed description: Develop and evaluate the effect of patient-centered cancer prehabilitation care program on improving fatigue, nutritional status and quality of life (QOL) in this population.

Eligibility: Inclusion Criteria:
  -  patients with pancreatic cancer and are going to receive surgery.
  Exclusion Criteria:
  -  poor functional status

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

Clinical trial: Norwegian Pancreatic Cancer Trial (NorPACT) - 1

Summary: This study evaluate the additional effect of adding chemotherapy prior to resection of a pancreatic head malignancy. The patients will be randomized into two groups; surgery first (control group) and neoadjuvant chemotherapy (intervention). Primary endpoint is overall survival after resection

Detailed description: Pancreatic cancer is the fourth leading cause of cancer-related deaths in Europe and the United States. Surgical resection remains the only potentially curative treatment. However, the median survival of patients undergoing pancreatic resection alone is 16-23 months. The administration of adjuvant chemotherapy leads to an improvement in overall survival. Thus, completion of multimodality treatment (MMT) is the ideal goal and standard of care for treatment of pancreatic ductal adenocarcinoma (PDAC).
  Currently, the surgery-first (SF) strategy is the most universally accepted approach to resectable PDAC (and is the standard of care in Norway), but the optimal sequence of surgery and chemotherapy remains unclear.
  The purpose of this study is to further investigate the additional efficacy of neoadjuvant chemotherapy to the standard treatment for resectable cancer of the pancreatic head (surgery followed by adjuvant chemotherapy).

Eligibility: Inclusion Criteria:
  -  Resectable adenocarcinoma of the pancreatic head
  -  T1-3, Nx, M0 (UICC 7th version, 2010)
  -  Cytologic or histologic confirmation of adenocarcinoma
  -  Age > 18 year and considered fit for major surgery
  -  Written informed consent
  -  Considered able to receive the study specific chemotherapy
  Exclusion Criteria:
  -  Co-morbidity precluding pancreaticoduodenectomy
  -  Chronic neuropathy ≥ grade 2
  -  WHO performance score > 2 • Granulocyte count < 1500 per cubic millimetre
  -  Platelet count < 100 000 per cubic millimeter
  -  Serum creatinine > 1.5 UNL (upper limit normal range)
  -  Albumin < 2,5 g/dl
  -  Female patients in child bearing age not using adequate contraception, pregnant or lactating women • Mental or organic disorders which could interfere with informed consent or treatments
  -  Other malignancy within the past 5 years, except non-melanomatous skin or non-invasive cervical cancer
  -  Percutaneous tumor biopsy
  -  Any reason why, in the opinion of the investigator, the patient should not participate
  -  Pregnancy
  -  Breastfeeding

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

Clinical trial: Impact of Prophylactic Octreotide to Pancreatic Exocrine Secretion

Summary: This study aims to examine whether octreotide has an effect on inhibition of the exocrine secretion fo the pancreas, which might lower the rate of postoperative pancreatic fistula after pancreatoduodenectomy. Patients who will undergo pancreatoduodenectomy for periampullary tumors were enrolled. The patients were randomly assigned to intervention (use of octreotide) or placebo groups. Octreotide was injected subcutaneously every 8 hours for 7 days. Every patients will undergo pancreaticojejunostomy with external stent for remnant pancreas management. The pancreatic juice is drained through the external stent by negative pressure and amounted.
  Primary endpoint was the amount of pancreatic juice for each postoperative day. Secondary endpoint was the rate of pancreatic fistula.

Detailed description: This study aims to examine whether octreotide has an effect on inhibition of the exocrine secretion fo the pancreas, which might lower the rate of postoperative pancreatic fistula after pancreatoduodenectomy. Patients who will undergo pancreatoduodenectomy for periampullary tumors were enrolled. The patients were randomly assigned to intervention (use of octreotide) or placebo groups. Octreotide of 100ug(1mL) was injected subcutaneously just before operation and every 8 hours for 7 days postoperatively. The placebo group was managed with normal saline (1mL) for same period. Every patients will undergo pancreaticojejunostomy with external stent for remnant pancreas management. The pancreatic juice is drained through the external stent by negative pressure (Barovac) and amounted.
  Postoperative care of patients was same between groups such as pain control and supportive care. The amount of drained pancreatic juice via external stent was recorded everyday.
  Primary endpoint was the amount of pancreatic juice for each postoperative day. Secondary endpoint was the rate of pancreatic fistula.

Eligibility: Inclusion Criteria:
  -  Patients who will undergo pancreatoduodenectomy for periampullary tumors
  Exclusion Criteria:
  -  Patients with preoperative pancreatitis
  -  Patients who did not undergo pancreatoduodenectomy
  -  Patients who underwent bypass surgery or total pancreatectomy
  -  Patients who injection of octreotide less than 5 days

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

Clinical trial: Circulating Cell-free Tumor DNA(ctDNA) in Pancreatic Cancer

Summary: The aim of the study is to evaluate whether peripheral circulating cell-free tumor DNA(ctDNA) can help early screening of pancreatic cancer recurrence or not. And we are also planning to evaluate correlation between ctDNA with clinical outcome of pancreatic cancer.

Detailed description: In the formation and growth of a primary tumor, cells can released into the bloodstream. There are many researches for these circulating tumor cells(CTC) And recently circulating cell-free tumor DNA(ctDNA) released from apoptotic or necrotic tumor cells has developed. At one report which checked ctDNA level after operation of colon cancer patients, they suggested that ctDNA could show recurrence of cancer several months earlier than the conventional follow up imaging. And several reports suggested that ctDNA can invade host cell and change host cell biology, which can evoke cancer metastasis.
  So in this study, we will collect ctDNA of pancreatic cancer patients who underwent operation, and will evaluate whether peripheral ctDNA can help early screening of cancer recurrence. And we will study about genomic signature of ctDNA to evaluate relationship between ctDNA and clinical outcome of cancer patients.

Eligibility: Inclusion Criteria:
  -  Pancreatic cancer patients who progress EUS-FNA for pancreatic cancer diagnosis
  -  Pancreatic cancer patients who are in operable stage.
  Exclusion Criteria:
  -  Foreigners
  -  Pancreatic cancer patients who have other cancer
  -  Patients who impossible to consent to study by own

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 Hydroxymethylation

Summary: The purpose of this study is to verify the function of p16 hydroxymethylation 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 hydroxymethylation diagnostic reagents in the early diagnosis of oral cancer, the investigators carried out the prospective multi-center double-blind cohort study.
  Methods:336 patients with histologically confirmed mild or moderate OED were included in the present study. After the bisulfite modification and tet assistant bisulfite modification, MethyLight and Methylation-specific PCR (MSP) assays were used to analyze p16 methylation and status in these patients. Building three follow-up queue by p16-methylated, p16-hydroxymethylation and p16-unmethylated. The Statistical analysis used SPSS16.0. 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 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: Sarcopenia is an Independent Prognostic Factor for Overall Survival in Patients With Pancreatic Adenocarcinoma

Summary: The primary objective of this study was to validate Total Psoas Area (TPA) measurement as an independent prognostic factor of overall survival in patients with pancreatic adenocarcinoma. Secondary objective was to describe the evolution of the TPA during the follow-up.


Eligibility: Inclusion Criteria:
  -  All patients consecutive enrolled from January 2009 to December 2015 who underwent at least one chemotherapy for pancreatic adenocarcinoma, whatever the stage
  Exclusion Criteria:
  -  A patient record captured outside the time frame from January 2009 to December 2015

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

Clinical trial: PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer

Summary: Does pancreas enzyme replacement (PERT) decrease weight loss and improve quality of life in patients with unresectable pancreatic cancer?

Detailed description: Randomized, double-blind clinical trial aiming to assess the impact of pancreas enzyme replacement therapy in weight loss and quality of life.
  Prevalence of pancreatic exocrine insufficiency (PEI) will be determined with fecal elastase-1 test (FE1) in patients with unresectable pancreatic cancer, without evidence of pancreatic duct (PD) or common bile duct (CBD) obstruction based on MRI or / and endoscopic ultrasound (EUS).
  Patients with PEI (FE1 <200) receive Pertzye or placebo in a cross-over fashion, each for 4 weeks.
  Body weight, body mass index (BMI), body composition (Bioimpedance), are measured at the time of diagnosis of PEI and at 4 and 10 weeks of cross-over treatment. Baseline measurement of Vitamin D-25, Vitamin A, iron (ferritin, total iron binding capacity (TIBC), iron), Vitamin B12,Tissue transglutaminase IgA (tTG) with total Immunoglobulin A (IgA).
  Quality of Life (pain, diarrhea, weight, bloating, etc.) assessed at 0,4,10 weeks with the Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer (FACT-Hep) for physical, social, emotional, and functional quality of life.

Eligibility: Inclusion Criteria:
  -  Patients 18-80 years
  -  Underlying pancreatic adenocarcinoma, unresectable (local invasion or distant metastasis)
  -  On established chemotherapy regimen for pancreas cancer, which will be continued over the time of study
  -  Fecal elastase-1 test (FE1) less than 200 mcg pancreatic elastase/g stool
  Exclusion Criteria:
  -  Common bile duct obstruction resulting in obstructive jaundice
  -  Celiac disease
  -  Crohn's disease
  -  Benign pancreatic conditions
  -  Bowel obstruction
  -  Surgically altered bowel anatomy

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

Clinical trial: Registry for Pancreatic Cancer

Summary: This is an observational, prospective and retrospective registry of patients with pancreatic cancer treated in Duke University Health System, which will examine patient and treatment effects on cancer outcomes.


Eligibility: Inclusion Criteria:
  -  Pancreatic cancer
  Exclusion Criteria:
  -  Younger than 18 years of age

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 of Azilsartan/Chlorthalidone and Irbesartan/Hydrochlorothiazide in Hypertension and Obesity.

Summary: This is an observational prospective study of azilsartan medoxomil / chlorthalidone compared with irbesartan / hydrochlorothiazide in routine therapy of patients with arterial hypertension and obesity.

Detailed description: Observational Prospective stUdy of aZilsartan medoxomil/ chlorthalidone compared with irbesartan/hydrochlorothiaZide combination therapy in patients with arteriaL hypertension and obEsity in routine clinical practice (PUZZLE).
  The study population is 94 patients with untreated or poorly controlled arterial hypertension and obesity.
  The main inclusion criteria are:
  1. Male and female 35-55 year old.
  2. Diagnosis of essential arterial hypertension I-II grade.
  3. Patients with obesity (BMI ≥ 30 kg/m²)
  4. Patients with untreated arterial hypertension (clinic SBP ≥ 140 mmHg, DBP ≥ 90 mmHg and no previous antihypertensive treatment.
  5. Patients with poorly controlled arterial hypertension (clinic SBP ≥ 140 mmHg, DBP ≥ 90 mmHg on previous antihypertensive treatment.
  6. Written informed consent.
  The main exclusion criteria are:
  1. Patients with symptomatic organ damage (myocardial infarction, stroke, angina pectoris, chronic kidney disease ≥ 4 grade, diabetes).
  2. Patients with secondary arterial hypertension.
  3. Patients with intolerance of angiotensin II receptor blockers, thiazide diuretic.
  4. Patients with contraindication to study drugs in accordance with Russian instruction.
  5. Patients currently enrolled in other clinical trials. The treatment period is 6 months. The study plan includes 4 basic and 1 additional visits are planned: initial visit, 3 follow-ups (including additional) and study-end visit.

Eligibility: Inclusion Criteria:
  1. male and female 35-55 year old,
  2. diagnosis of I-II grade essential AH,
  3. patients with obesity (BMI ≥ 30 kg/m²),
  4. patients with untreated AH (office SBP ≥ 140 mmHg, DBP ≥ 90 mmHg, no previous antihypertensive therapy),
  5. patients with poorly controlled AH (office SBP ≥ 140 mmHg, DBP ≥ 90 mmHg on previous antihypertensive therapy),
  6. written informed consent form (ICF).
  Exclusion Criteria:
  1. patients with symptomatic organ damage (myocardial infarction, stroke, angina pectoris, chronic kidney disease stage ≥ 4, diabetes),
  2. patients with intolerance of ARB, thiazide diuretics,
  3. secondary AH,
  4. patients with contraindication to study drugs in accordance with Russian instruction,
  5. patients currently enrolled in other clinical trials.

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

Clinical trial: High-activity Natural Killer Immunotherapy for Small Metastases of Pancreatic Cancer

Summary: The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of pancreatic cancer.

Detailed description: By enrolling patients with small metastases of pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer cells.
  The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility: Inclusion Criteria:
  -  All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
  -  Body tumor 1-6, the maximum tumor length < 2 cm
  -  KPS ≥ 70, lifespan > 6 months
  -  Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L
  Exclusion Criteria:
  -  Patients with cardiac pacemaker
  -  Patients with brain metastasis
  -  Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary 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: Relation Between Cachexia, Diabetes and periNeural Invasion in PANcreatic Cancer- Biomarkers Substudy

Summary: The purpose of this study is to determine the interrelationship between cachexia, neural invasion and diabetes in patients with pancreatic cancer. Thus the investigators propose to identify the protein expression levels of Activin and Midkine in plasma of patients with different stages of pancreatic adenocarcinoma compared with healthy patients and to evaluate the possible correlation with diabetes, tumor size and tumor stage.

Detailed description: In this study, the investigators will prospectively evaluate pancreatic adenocarcinoma patients with or without cachexia, perineural invasion and diabetes.
  Patients with pancreatic ductal adenocarcinoma, based on the results of an endoscopic ultrasonography (EUS) biopsy or surgery were enrolled at the diagnosis and blood samples are drawn.
  Thus the investigators propose to identify the protein expression levels of Activin and Midkine in plasma of patients with different stages of pancreatic adenocarcinoma compared with benign pancreatic disorders and healthy patients and to evaluate the possible correlation with diabetes, tumor size and tumor stage.
  Furthermore, the investigators propose to identify the prognostic role of these biomarkers in the development of metastasis and survival in patients with adenocarcinoma, with and without diabetes and cachexia; to identify a new biomarker predictive of cachexia and eventually to select patients likely to benefit from treatment with antagonists of activin (or hypoglycemic treatment) and investigating the role of invasion neural in the appearance of cachexia in patients with pancreatic adenocarcinoma.
  Follow-up: with phone-calls on an every 6 month, for up to 2 years, retaining the following data: survival, date of decease and its direct cause, the presence of tumor recurrence.

Eligibility: Inclusion Criteria:
  1. Age over 18 years old
  2. EUS or surgery biopsy confirming the diagnosis of adenocarcinoma
  3. Informed consent
  Exclusion Criteria:
  1. obvious malabsorption
  2. artificial nutrition
  3. hyperthyroidism
  4. major depression
  5. other causes of malnutrition
  6. refusing to enter 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: A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib

Summary: This study will allow for the collection of tumor tissue samples to better understand relevant mutations and the mechanisms responsible for resistance to treatment.

Detailed description: This protocol is a sub-protocol of an interventional study. Because the main study is interventional, this study was approved by FDA as an interventional study. It cannot stand alone without the parent study. The sites will receive diagnostic information for all patients that come on study.

Eligibility: Inclusion Criteria:
  -  Written informed consent must be obtained prior to any baseline/screening procedures.
  -  Patients eligible for this companion sample collection protocol sample collection protocol must meet all inclusion in CLEE011A2404.
  Exclusion Criteria:
  -  Patients eligible for this companion sample collection protocol must not meet any of the exclusion criteria in the CLEE011A2404 study, in addition to the following:
  -  Patients without either fresh or archival tumor tissue accessible.

Relevance to patient case: not relevant