araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Effects of Drainage in Laparoscopic Cholecystectomy

Summary: During laparoscopic surgery for an acutely inflamed gallbladder, most surgeons routinely insert a drain. However, no consensus has been reached regarding the need for drainage in these cases, and the use of a drain remains controversial. This study is coordinated to find out the surgical outcomes and perioperative morbidity according to the insertion of drain after laparoscopic cholecystectomy. Investigators expect that the routine use of a drain after laparoscopic cholecystectomy for an acutely inflamed gallbladder will have no effects on the postoperative morbidity.

Detailed description: Drain has been widely used in many abdominal surgeries for therapeutic purposes such as the removal of infected debris or abscess, and supporting the healing of leakage or fistula. Although the usability of therapeutic drain is commonly accepted, the efficacy of prophylactic drain still has been debated. Most surgeons have inserted prophylactic drain with expectations that the drain would be helpful for early detection of postoperative bleeding or leakage, and also prevention of intra-abdominal abscess through removing debris or curd. However, there are only few evidence-based studies for the actual effectiveness of prophylactic drain and the objections against the routine use of drain have been raised.
  Most surgeons have placed the drain after cholecystectomy with expectations that it could help to detect postoperative bleeding or bile leakage and prevent intra-abdominal infection. However, there is a lack of evidence regarding the role of drain in laparoscopic cholecystectomy for acutely inflamed gallbladder and surgeons have placed the drain based on their experiences and beliefs, not on evidence-based guidelines. In the previous retrospective study, [4] we described that the routine drain use in laparoscopic cholecystectomy for acutely inflamed gallbladder has no advantage to detect bile leak or bleeding and it was no helpful to prevent the postoperative morbidities such as intra-abdominal abscess or wound infection. The aim of present multicenter trial is to assess the value of routine drain use in laparoscopic cholecystectomy for acutely inflamed gallbladder in a large, randomized controlled prospective study.

Eligibility: Inclusion Criteria:
  -  acutely inflamed gallbladder
  Exclusion Criteria:
  -  chronic cholecystitis
  -  gallbladder polyp or gallbladder cancer
  -  the patient who underwent reduced port surgery
  -  the patient who underwent common bile duct exploration during the operation
  -  the patient who underwent concurrent operation
  -  the patient who had past history of upper abdominal surgery
  -  the patient who had a immunodeficiency state
  -  the case which had a suspicion of delayed bile leakage
  -  the case which had a incomplete cystic duct ligation
  -  the patient who underwent open conversion surgery during the operation
  -  the patient who had a high risk of bleeding

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Post-Marketing Requirement to Evaluate the Safety of Octaplas™ Versus Plasma in Patients Undergoing Orthotopic Liver Transplantation With Special Emphasis on Hyperfibrinolysis.

Summary: Post-Marketing Requirement study to evaluate the safety of octaplas™ versus plasma in patients undergoing orthotopic liver transplantation (OLT). The primary objective is to assess the incidence of hyperfibrinolysis in patients undergoing (OLT) receiving octaplas™ versus regular plasma (e.g., fresh frozen plasma and other FDA and AABB approved plasma products).


Eligibility: Inclusion Criteria:
  -  Male or female age ≥18 years
  -  Patient is scheduled to undego orthotopic liver transplantation (OLT)
  -  Patient has a natural MAYO End-Stage Liver Disease (MELD) score of 15-40
  -  Patient is willing to give voluntary written informed consent before any study- related procedure is to be performed that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudicing future medical care
  Exclusion Criteria:
  -  Patient has a history of severe hypersensitivity reaction to plasma-derived products or to any excipient of the investigational product
  -  Patient is known to be IgA deficient with documented antibodies against IgA
  -  Patient is a planned recipient for a living donor OLT
  -  Patient has a severe deficiency of Protein S
  -  Patient is currently participating in an interventional clinical study or has participated in one within 30 days of the date of their OLT

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: A Study of Rucaparib in Patients With Pancreatic Cancer and a Known Deleterious BRCA Mutation

Summary: The purpose of this study is to determine whether oral rucaparib is effective in the treatment of patients with locally advanced or metastatic pancreatic cancer and a known deleterious BRCA mutation.

Detailed description: Rucaparib is an orally available, small molecule inhibitor of poly-adenosine diphosphate [ADP] ribose polymerase (PARP) that inhibits a specific DNA repair pathway known as base excision repair (BER). PARP inhibitors (PARPi) have been shown to effectively kill tumors with a defect in BRCA1 or BRCA2. Clinical benefit has been observed in patients with a gBRCA mutation as well as in those with a somatic BRCA (sBRCA) mutation. Clinical data have also shown that pancreatic cancer patients with a gBRCA mutation benefit from PARPi treatment. Clinical activity of PARP inhibitors in BRCA-mutated pancreatic cancer combined with the paucity of 2nd line therapies support evaluation of rucaparib in pancreatic cancer patients known to harbor a deleterious BRCA mutation.

Eligibility: Inclusion Criteria:
  -  Confirmed diagnosis of pancreatic cancer (ductal adenocarcinoma and related subtypes eligible; endocrine and neuroendocrine tumors excluded)
  -  Received at least 1, but no more than 2, chemotherapy-based regimens for locally advanced or metastatic disease and has relapsed or progressive disease. Patients no longer able to continue treatment with chemotherapy due to intolerable toxicity may be considered for study participation provided that radiology assessment confirms either stable disease or disease progression (i.e. no response to treatment)
  -  Documented deleterious or suspected deleterious (or equivalent interpretation) BRCA mutation (germline or somatic) as assessed by a local laboratory
  -  Measurable disease
  Exclusion Criteria:
  -  Presence of another active cancer
  -  Prior treatment with any PARP inhibitor, including rucaparib. Patients treated with prior iniparib are eligible.
  -  Symptomatic and/or untreated central nervous system metastases.
  -  Clinical evidence of malabsorption and/or any other gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with the absorption of rucaparib.

Relevance to patient case: possibly relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Prostate Cancer Screening Among Men With High Risk Genetic Predisposition

Summary: This will be a prospective diagnostic trial of screening for prostate cancer among men with genetic predisposition.

Detailed description: This will be a prospective diagnostic trial of screening for prostate cancer among men with genetic predisposition. The target population is males (40-70 year old) carrying a BRCA1 and/or BRCA2 germ line mutation. They will be identified via our Genetic counseling unit. All men after signing an informed consent will undergo the following tests: PSA, free to total PSA, MRI of prostate and prostate biopsy. The primary endpoint will be to estimate the prevalence, stage and grade of prostate cancer in this population. Additionally, the study aims to estimate the impact of these germ line mutations on benign prostatic hyperplasia. Furthermore, this study aims to create a bio-bank of tissue, urine and serum of this unique cohort for future investigations. Finally, this study will identify an inception cohort for future interventional studies of primary and secondary prevention.

Eligibility: Inclusion Criteria:
  -  Male carrier of mutation in BRCA 1\2 or germ-line mutations in the MMR genes (MLH1, MSH2 , MSH6 or PMS2).
  -  WHO performance status 0-2 (Appendix 2)
  -  Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.
  -  Individuals that cannot undergo the MRI exam due to high creatinine level or claustrophobic will be disc loud from the MRI part.
  -  Informed written consent must be sought according to ICH/EU GCP, before subject registration.
  Exclusion Criteria:
  -  Previous cancer with a terminal prognosis of less than five years.
  -  Previous prostate cancer

Relevance to patient case: possibly relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS)

Summary: Photodynamic therapy (PDT) is a combination of a drug, porfimer sodium (Photofrin), which is activated by a light from a laser that emits no heat. This technique works to allow the medical doctor to specifically target and destroy abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation of the drug is done by lighting the abnormal areas using a fiber optic device (very fine fiber like a fishing line that permits light transmission) inserted into a flexible tube with a light called cholangioscope for the bile duct. The light will activate the porfimer sodium concentrated in the abnormal tissue, leading to its destruction.
  This research study will evaluate the efficacy and safety of PDT with porfimer sodium administered with Standard Medical Care (SMC) compared to SMC alone on the overall survival time of patients with non-operable advanced cholangiocarcinoma, a rare cancer of the bile ducts. It will involve 200 patients across North America and Europe. Other countries may participate if needed. Participation will last at least 18 months.


Eligibility: Inclusion Criteria:
  -  Males or females aged 18 or older
  -  Diagnosed with radiologically and biopsy or cytology confirmed inoperable perihilar cholangiocarcinoma Bismuth Tumor Stage III/IV
  -  Non-menopausal or non-sterile female subjects of childbearing potential must have a negative serum beta-HCG and use a medically acceptable form of birth control
  -  Able to sign an informed consent
  Exclusion Criteria:
  -  Diagnostic of cholangiocarcinoma made more than 45 days prior to randomization
  -  Cholangiocarcinoma with extra-hepatic metastasis or concurrent non-solid malignancy
  -  Presence or history of other neoplasms (treated during the last five years prior to study entry) other than carcinoma in situ of the cervix or basal carcinoma of the skin
  -  Previously received photodynamic therapy for cholangiocarcinoma
  -  Previously undergone surgical resection of the cholangiocarcinoma
  -  Previously undergone chemotherapy, brachytherapy, or radiotherapy prior to entering the study
  -  Previously undergone metal stent insertion
  -  Porphyria or hypersensitivity to porphyrins (constituents of porfimer sodium), gemcitabine, cisplatin or other platinum-containing compounds
  -  Presence of infection other than the infection of the bile duct (cholangitis)
  -  Acute or chronic medical or psychological illnesses that prevent endoscopy procedures
  -  Abnormal blood test results
  -  Severe impairment of your kidney or liver function
  -  Decompensated cirrhosis
  -  Pregnant or intend to become pregnant, breastfeeding or intend to breast-feed during this study
  -  Participated in another drug study within 90 days before this one
  -  Unable or unwilling to complete the follow-up evaluations required for the study

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: VEGF Signaling Promotes Cell Growth and Metastasis in Extrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway (ECC)

Summary: The investigators study the VEGF signaling in ECC cell lines,patients and its mechanism in ECC growth, proliferation and apoptosis.

Detailed description: Several studies have documented the elevated expression of VEGF, VEGFR1 and VEGFR2 in cancer cell lines. Another study observed a sequential elevation of VEGF in low-grade dysplasia, high-grade dysplasia and early stage liver cancer. Clinical analyses have discovered the high expression of VEGF is correlated with tumor progression, vascular invasion, distal metastasis and poor prognosis. However, few studies have been conducted to investigate the VEGF signaling in ECC cells and its possible mechanism in regulating ECC growth.Therefore,we try to clarify the mechanism of VEGF signal in ECC growth,proliferation and apoptosis.

Eligibility: Inclusion Criteria:
  1. Extrahepatic cholangiocarcinoma patients diagnosed through biopsy; two or more dynamic imagine with a diagnosis of Extrahepatic cholangiocarcinoma
  2. Child-Pugh A or B
  3. well preserved renal and hematopoietic Function
  4. receive surgical therapy
  5. achieve complete section accessed by contrast-enhanced CT
  Exclusion Criteria:
  1. incomplete section
  2. remote metastasis
  3. Child-Pugh C
  4. combination with other hepatobiliary disease
  5. suffer from other tumors concurrently or in last five years

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer

Summary: Investigation of the effects of daily sildenafil on patients with pancreatic or cholangiocarcinoma cancer undergoing treatment.

Detailed description: This is a double-blinded, placebo-controlled trial in men and women, 40-75 years old, diagnosed with pancreatic or cholangiocarcinoma cancer. Patients will receive placebo or sildenafil daily for 4 weeks during their initial chemotherapy cycle.

Eligibility: Inclusion Criteria:
  1. Men and women, aged 40-75 years.
  2. Diagnosed with Stage III or IV pancreatic or cholangiocarcinoma receiving the following therapy:
  -  Neoadjuvant chemotherapy
  -  Surgical resection followed by chemotherapy.
  3. Able to comprehend risks and sign a consent form.
  4. Performance Status of 0-2.
  Exclusion Criteria:
  1. Significant renal or heart disease or any acute metabolic disease.
  2. Evidence of hepatitis as indicated by a 3-fold increase in of 2 out of 3 liver enzymes.
  3. Diabetes mellitus or other untreated endocrine disease.
  4. Recent (within 3 months) treatment with anabolic steroids.
  5. Ongoing anticoagulant therapy.
  6. Androgen secreting tumors of the ovary and adrenal or any ovarian tumor (e.g., Sertoli-Leydig).
  7. Polycystic ovary syndrome (PCOS) and/or hyperthecosis.
  8. Non-classical adrenal hyperplasia.
  9. Cushing's syndrome.
  10. Glucocorticoid resistance.
  11. Pregnancy.
  12. Hyperprolactinoma, hypothyroidism.
  13. Use of nitrates.
  14. Use of alpha blockers.
  15. Use of protease inhibitors.
  16. Use of cytochrome p450 inhibitors.
  17. Systolic blood pressure <100 or >150, diastolic blood pressure <60 or >90. This range is smaller than the acceptable range stated in the prescribing information for sildenafil (>90/50 and <170/110).
  18. Peripheral vascular disease.
  19. Use of a phosphodiesterase 5 inhibitor.
  20. Any other circumstance deemed exclusionary by the PI or study physician.

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Results of Bile and Blood Culture in Patients With Acute Cholangitis

Summary: Cholangitis is a complication of biliary statsis. Bile juice is sterile when there is no obstruction, however, it can be infected with bacteria when there is a stasis or obstruction. After infection, cholangitis can be developed because of systematic endotoxemia or bacteremia. Though identification of bacteria is very important for selection of adequate antibiotics, treatment with empirical antibiotics is commonly performed when identification of bacteria is not possible.
  Identification of bacteria is usually done with blood or bile culture. In the previous studies, the same results from blood and bile were common in patients with cholangitis. However, the data of these studies were based on the bile juice which was aspirated by surgery. Considering that bile duct obstruction is usually treated with endoscopy or radiological intervention without surgery, it is necessary to collect data with endoscopic or radiologic intervention. In addition, the concordant rate of these two tests has not been reported according to severity of cholangitis. As a result, the necessities of bile and blood culture are not agreed among experts in this fields.
  Our hypothesis is that concordant rates of bile and blood culture are same in patients with each moderate or severe cholangitis. However, the concordant rates of bile and blood culture are different between patients with moderate and severe cholangitis. This study will assess the positive rates of blood and bile culture in patients with moderate or severe cholangitis, respectively and compare the results according to the different severity.


Eligibility: Inclusion Criteria:
  -  Patients with moderate or severe cholangitis which fullfilled the criteria by the Tokyo Guidelines (Tanaka A, Takada T, Kawarada Y, et al. Antimicrobial therapy for acute cholangitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg 2007;14:59-67.)
  -  Patients who are successfully treated with endoscopic or radiologic biliary drainage
  -  Patients who undergo both blood and bile culture tests
  Exclusion Criteria:
  -  Patients with other infections except cholangitis or cholecystitis
  -  Patients who received surgical biliary drainage treatment
  -  Patients who are treated with endoscopic or radiologic biliary drainage more than 24 hours after using initial antibiotics
  -  Patients who does not agree with informed consent or who are vulnerable subjects

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Percutaneous Bilateral Versus Unilateral Metal Stent for Hilar Cholangiocarcinoma

Summary: Cholangiocarcinoma (CCA) is the most common biliary malignancy and the second most common hepatic malignancy after hepatocellular carcinoma (HCC). A majority of the CCA (50-70%) was presented in the area of the biliary duct bifurcation. Recent retrospective study included heterogeneous group of malignant diseases demonstrate that draining more than 50% of was associated with a longer median survival.
  However, in recent European Society of Gastrointestinal Endoscopy (ESGE) biliary stenting clinical guideline and Asia-Pacific consensus recommendations for endoscopic and interventional management of hilar cholangiocarcinoma (HCCA), whether we should deployment bilateral or unilateral metal stent for patients with HCCA was not clearly recommended due to the absence of randomized controlled trials.

Detailed description: Patients with advanced hilar obstruction (Bismuth III and IV), PTBS had a higher success rate of cholestasis palliation and a low rate of post cholangitis when compared with endoscopic retrograde cholangiopancreatography(ERCP). The advantage of percutaneous approach is the precise lobar selection for drainage and this approach should yield a lower rate of cholangitis.
  Guideline recommendation European Society of Gastrointestinal Endoscopy (ESGE) biliary stenting clinical guideline and Asia-Pacific consensus recommendations the goal of palliative stenting of HCCA is drainage of adequate liver volume (50% or more), irrespective of unilateral, bilateral, or multi-segmental stenting was based on heterogeneous group of malignancy by ERCP in retrospective study.There are no randomized clinical trials compared with these two internal biliary drainage methods in HCCA using metal stent.
  The aim of the present study was to compare the effect and safety of bilateral versus unilateral stenting in patients with HCCA.

Eligibility: Inclusion Criteria:
  Written informed consent; Jaundice duo to biliary obstruction; The diagnosis is based on typical features on MRI and magnetic resonance cholangiopancreatography or histologic and cytologic confirmation is established by percutaneous biopsy (X ray-guided) or exploratory laparotomy; Bismuth type Ⅱ、Ⅲ、Ⅳobstruction; Performance status (eastern cooperative oncology group, ECOG) 0-2; All patients were considered unsuitable or refuse for resection on the basis of general medical condition and/or tumor extent.
  Exclusion Criteria:
  Refuse to participate and provide informed consent; Bismuth Ⅰtype obstruction; Performance status (eastern cooperative oncology group, ECOG) 3-4. Portal Vein involvement; Prior history of stent; Concomitant renal insufficiency; Severe cardiopulmonary diseases; Uncontrolled systemic infection or sepsis; Accompany other malignancy or serious medical illness which may reduce the life expectancy.
  Contraindications for PTBS.

Relevance to patient case: not relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Von Willebrand Factor to Predict Postoperative Outcome

Summary: vWF is stored in weibel-palade-bodies of endothelial cells as well as alpha-granula of platelets and is released upon their activation. Endothelial cell dysfunction as well as platelet activation often occur in liver disease and portal hypertension, which may lead to an increase in circulating vWF levels. Indeed, multiple studies have reported that liver disease is associated with increased circulating vWF- antigen (vWF-Ag). Furthermore, increased circulating vWF -Ag Levels have been shown to be associated with increased mortality rates in patients with chronic liver disease. Within a prospective evaluation cohort, the investigators were able to document that patients with increased vWF-Ag levels prior to liver resection suffered from an increased incidence of postoperative liver dysfunction and morbidity. Within this prospective multicenter validation study, the investigators now aim to prospectively validate that circulating vWF-Ag prior to liver resection is a valuable marker to predict postoperative clinical outcome.


Eligibility: Inclusion Criteria:
  -  patients undergoing liver resection
  -  only patients with either hepatocellular carcinoma, cholangiocellular carcinoma or colorectal cancer liver metastasis will be included
  Exclusion Criteria:
  -  inherited coagulopathy
  -  age > 85

Relevance to patient case: not relevant