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

Clinical trial: Reconstruction of the Bile Duct With the Round Ligament

Summary: The investigators developed a new surgical technique in order to reconstruct the bile duct with the round ligament

Detailed description: Classically, the bile duct defect after bile duct injury or resection is achieved by bilioenteric reconstruction. However bilioenteric anastomosis is associated with long term complications including intrahepatic bile ducts infection, specific complications related to the Roux en Y jejunal loop and eliminate the endoscopic access to intrahepatic bile ducts. The investigators had recently developed a new surgical technique to reconstruct the veins with the parietal peritoneum with excellent results. Accordingly the investigators decided to develop a new surgical technique in order to reconstruct the bile duct defects with the vascularized round ligament.

Eligibility: Inclusion Criteria:
  1. Radiological or operative diagnosis of bile duct Injury or defect
  2. Can underwent surgical procedure
  Exclusion Criteria:
  1) The absence of the round ligament

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

Clinical trial: Addressing Diabetes Together

Summary: Integration of Diabetes Prevention Program (DPP) and Diabetes Self Management Program (DSMP) into WellConnect.


Eligibility: Inclusion Criteria:
  -  Adults 18 years or older
  -  Diagnosis of diabetes
  -  enrolled in the DSMP or DPP
  Exclusion Criteria:
  -  unable to provide consent

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 Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablation Intra-Hepatic Cholangiocarcinoma

Summary: Compare the efficacy of adjuvant chemotherapy with Cisplatin or Carboplatin and Gemcitabine versus Gemcitabine in patients with resected or ablated intra-hepatic cholangiocarcinoma.

Detailed description: Phase III, multicenter, open label, randomized study of Cisplatin or Carboplatin with Gemcitabine versus Gemcitabine alone as adjuvant therapy in patients with resected or ablated intra-hepatic cholangiocarcinoma. Subjects will be randomized in a 1:1 fashion to Cisplatin or Carboplatin with Gemcitabine versus Gemcitabine alone.

Eligibility: Inclusion Criteria:
  -  At least 18 years of age, of any race or sex who are eligible to sign written consent and have undergone prior resection of histological evidence of intrahepatic cholangiocarcinoma
  -  Hematologic function: ANC ≥ 1.5 x 10 /L, platelets ≥ 75 x 10 /L, and hemoglobin > 9 g/dL
  -  Adequate liver function as measured by: total bilirubin ≤ 2.0 mg/dl, AST and ALT ≤ 5 ULN, albumin ≥ 2.5 g/dl
  -  Adequate renal function as measured by: creatinine ≤ 2.9 mg/dl, > 50 ml/min calculated by the C-G equation
  -  Non-pregnant women of child bearing potential and fertile men are required to use effective contraception (negative pregnancy test for women of child-bearing age)
  -  ECOG status ≤ 1 at screening
  Exclusion Criteria:
  -  Subjects will be eligible for the study if they meet all inclusion criteria

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

Clinical trial: Molecular Breast Imaging in Screening Breast Cancer

Summary: The molecular breast imaging (MBI) is a potential modality to screen breast cancer. In this study, we compare and evaluate the recall rate/diagnostic efficiency of MBI, mammography and breast sonography, and aim to determine best ways of breast cancer screening.

Detailed description: Keywords: molecular breast imaging, MBI, breast cancer, mammography, sonography
  1. Background: In breast cancer screening, the sensitivity of mammography is about 71-96 %, but the sensitivity decreases in the three following groups: (1) under 50 years old; (2) dense breast parenchyma; (3) higher risk of breast cancer. The Health and Welfare Ministry data in recent 2 years showed Taiwanese women accepted mammography for screening in the ratio of only about 36%, representing many missed opportunities for early detection. One reason to reject mammography may be the discomfort caused by compression. To solve the above mammography possible weakness, other screening methods came into being, such as molecular breast imaging (MBI) of nuclear medicine. Radiotracer of Tc-99m sestamibi was found for targeting breast tumor 20 years ago, and approved by the FDA in 1997. However, the application is limited due to the suboptimal scanning camera design. Ten years later, the Mayo Clinics developed MBI technology, using small-sized semiconductor detectors. Then it become possible that the nuclear technologist have patient's breast tissue fit the detector in almost the same fashion of mammography without heavy compression.
  2. Objective: The aim of this study is to evaluate the recall rate and diagnostic accuracy of MBI, mammography and breast echo, for female population.
  3. Study design: Female patients referred to Nuclear Medicine Department for myocardial perfusion scan will be recruited in this study. It is because that MBI and myocardial perfusion scan share the same radiotracer. Then MBI will become additional scanning only. About 1800 female subjects will involve, and further mammography and/or breast sonography will be arranged within 6 months after MBI. Participants will be encouraged to receive mammography every 2 years and telephone survey. We hope that this study will help us to compare and evaluate the recall rate/diagnostic efficiency of MBI, mammography and breast sonography, and to determine best ways of breast cancer screening.

Eligibility: Inclusion Criteria:
  -  Female patients undergoing myocardial perfusion imaging will be eligible if they sign the informed consent.
  Exclusion Criteria:
  -  They are unable to understand and sign the consent form
  -  They are physically unable to sit upright and still for 20 minutes.
  -  They have undergone breast surgery or breast biopsy within the last 12 months.
  -  They have had trauma to the breast tissue or undergone radiation treatment to the breast within the last 12 months.

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

Clinical trial: Prevalence of BRCA1 and BRCA2 Mutations in Ovarian Cancer Patients in the Gulf Region

Summary: A prospective, multi-centre, epidemiological observational study designed to evaluate the prevalence of BRCA1 and BRCA2 (BReast CAncer gene) mutations in current and newly diagnosed ovarian cancer patients across different countries in the Gulf region. This study will also describe the epidemiological features for the disease for the enrolled patients.


Eligibility: Inclusion Criteria:
  1. Subjects willing to sign the informed consent form (ICF)
  2. Female subjects 18 years of age or older
  3. Have histologically confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) ovarian epithelial, primary peritoneal cancer made by one or more of the following:
  1. Standard staging laparotomy including bilateral salpingo-oophorectomy,omentectomy, and lymph node sampling and debulking and/or
  2. Surgical resection and radiographic evidence consistent with ovarian cancer
  3. Paracentesis or biopsy with radiographic evidence consistent with ovarian cancer(normal appearing pancreas, liver, and gastrointestinal tract).
  4. Have availability of paraffin-embedded archived tumor tissue block (preferred) or, if a block is not possible, a minimum of twenty 10-um sections.
  Exclusion Criteria:
  Patients who meet any of the following criteria are ineligible to participate in the study and hence will not be consented:
  1. The diagnosis is not of a primary ovarian cancer; thus, patients will be excluded if a previous cancer has metastasized to the ovary, or if there is a secondary malignancy that is associated with the ovarian cancer.
  2. Is not able or willing to provide written informed consent.
  3. Have a diagnosis of other severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of the study.
  4. Be a patient who, in the judgment of the Investigator, would be inappropriate for enrollment in this study.
  A rationale will be documented for all patients who are screened and ultimately excluded from the study as a result of meeting any of the aforementioned exclusion criteria

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

Clinical trial: ncRNAs in Exosomes of Cholangiocarcinoma

Summary: Exosomes are part of extracellular vesicles(EVs), and can be secreted into the environment by many types of cells. It has been demonstrated that the content and function of exosomes depends on the originating cell and the conditions under which they are produced.Exosomes contain proteins,RNAs and lipid,which may transfer biological information and activities from donor cells to receptor cells. Non-coding RNAs are involved in many biological activities including tumor growth and metastasis.
  In this prospective translational study, preclinical and clinical phases have been designed. On the first step, the main goal is to characterize the ncRNAs of cholangiocarcinoma derived exosomes. This exosome biomarker may provide a useful diagnostic tool. As a second step, the study will evaluate the prognostic and predictive value of cholangiocarcinoma exosomes levels in plasma in a prospectively recruited cohort of cholangiocarcinoma patients before and after surgical resection.


Eligibility: Inclusion Criteria:
  -  1.Provide signed informed consent. The subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign informed consent, approved by the Independent Ethic Committee (IEC)/Institutional Review Board (IRB) prior to the initiation of any study-specific procedures.
  2.Men or women aged >= 18 years. 3.Histology- or imaging-confirmed bile duct stricture. 4.Metastatic disease or locally advanced disease not amenable to curative surgery.
  5.Radiographically assessable, non-measurable disease or measurable disease as per RECIST criteria.
  6.Life expectancy of at least 8 weeks from the time of enrollment. 7.No other malignancy within the past 5 years. 8.No prior chemotherapy for advanced disease.
  Exclusion Criteria:
  - 1.Pregnant or lactating females. 2.Significant neurological or psychiatric disorders (psychotic disorders, dementia or seizures) that would prohibit the understanding and giving of informed consent.
  3.Active Hepatitis B or C or history of an HIV infection. 4.Active uncontrolled infection.

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

Clinical trial: Microbiomes in Patients of Recurrent Common Bile Duct Stones

Summary: Bile duct stones is a common biliary tract disease, which is characterized by high morbidity and frequent recurrence. Endoscopic retrograde cholangiopancreatography (ERCP) is an effective therapy for common bile duct stones, and endoscopic sphincterotomy (EST) which associated with recurrent cholangiolithiasis often carried out on difficult intubation or extracting stones, probably due to enhanced reflux of intestinal contents that changes the microenvironment. Patients with cholangiolithiasis were consecutively recruited and their bile was collected intra-operatively for high-throughput experiments. Pyrosequencing of 16S ribosomal RNA gene was performed to characterize the microbiota in the bile and other body fluids. A liquid chromatography mass spectrometry-based method was used to profile bile composition. Clinical manifestation, microbiome, and bile composition were compared between patients with or without recurrent of bile duct stones. The aim of our study was to identify the impact of microbiomes on the recurrent of bile duct stones after ERCP+EST therapy.


Eligibility: Inclusion Criteria:
  1. Patients with recurrent common bile duct stones.
  2. No antibiotics or probiotics are used for nearly three months.
  3. In addition to common bile duct stones, possibly without other digestive diseases.
  Exclusion Criteria:
  1. Significant neurological or psychiatric disorders (psychotic disorders, dementia or seizures) that would prohibit the understanding and giving of informed consent.
  2. Pregnant or lactating females.
  3. Active Hepatitis B or C or history of an HIV infection.
  4. Active uncontrolled infection.
  5. Billroth II or roux-en Y gastrointestinal alteration people.

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

Clinical trial: Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma

Summary: The purpose of this study is to determine the effect of normal temperature and 37℃ non-ionic contrast agent acting on ERCP-related cholangeitis after endoscopic retrograde cholangiopancreatography (ERCP) in the treatment of hilar cholangiocarcinoma.

Detailed description: At present, the common used contrast agent in ERCP is composed of ionic and non-ionic type, and the latter's advantages lie in its slighter toxic-and-side effect and favorable security. When heated to 37℃, the 20 ℃ contrast agents would be diluted to 50% consistency, then a shorter time period of its intravascular and other intracavitary stay would add to less cell damage. And the applications of heated non-ionic contrast agents could be found in computed tomography angiography(CTA), hysterosalpingography (HSG) and cystourethrography, and consequently the patients with the intervention of heated non-ionic contrast agents felt more comfortable and fewer adverse reactions could be observed. Nevertheless, heated contrast agent was rarely reported to act in ERCP. It's theoretically possible that its heat-reduced lower mucosity could help the contrast agent itself to drainage, so that the incidence of cholangeitis could be under control.

Eligibility: Inclusion Criteria:
  -  Type Ⅰ、Ⅱ、Ⅲ、Ⅳ of Hilar Cholangiocarcinoma;
  -  Age: 18~90 years old;
  -  Underwent diagnostic and therapeutic ERCP;
  Exclusion Criteria:
  -  Coagulation dysfunction(INR＞1.3) or/and low peripheral blood platelet count （PLT <50x10^9/L）;
  -  Preoperative acute cholangitis;
  -  Preoperative acute pancreatitis;
  -  Preoperative hemobilia or hemorrhage of digestive tract;
  -  Preoperative liver failure;
  -  Combined with Mirizzi syndrome and intrahepatic bile duct stones;
  -  Preoperative malignant tumor of biliary system such as carcinoma of head of pancreas, gallbladder carcinoma;
  -  Biliary-duodenal fistula confirmed during ERCP;
  -  A history of reconstructive surgery for upper digestive tract except Billroth Ⅰand a history of cholangioenterostomy including cholangio-jejunostomy and side to side anastomosis of the bile duct and duodenum;
  -  Previous ERCP;
  -  Pregnant women

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas

Summary: Radiotherapy plus Single-Agent Chemotherapy/Radiosensitization. Involved-field irradiation using 4-15 MV photons; plus Gemcitabine, NSC-613327.

Detailed description: This is a Phase I trial of gemcitabine given weekly as a 30 minute infusion administered concurrently with radiation in patients with locally advanced or locally recurrent pancreatic carcinoma. Patients will be treated with external beam radiation therapy in a standard manner. Gemcitabine will be administered as a 30 minute infusion beginning on the first day of irradiation and weekly afterwards for a total of 5 doses. Patients will be assessed clinically for acute toxicity which will be graded per RTOG and DCT toxicity grading system.

Eligibility: DISEASE CHARACTERISTICS:
  Histologically or cytologically proven unresectable adenocarcinoma of the pancreas or ampulla of Vater. Surgical consult at NCI confirming unresectability fulfills requirement.
  Unresectable disease defined as tumor with: Gross involvement of regional nodes or direct extension to any of the following sites: Duodenum, Spleen, Bile duct , Colon, Peripancreatic tissue, Adjacent large vessels, Stomach.
  Metastatic disease requiring local radiotherapy allowed. No CNS metastasis.
  No lymphomas or neuroendocrine tumors.
  No peritoneal carcinomatosis.
  PRIOR/CONCURRENT THERAPY:
  Biologic Therapy: More than 4 weeks since immunotherapy.
  Chemotherapy:
  No prior chemotherapy for newly diagnosed disease.
  More than 4 weeks since chemotherapy for recurrent disease (6 weeks since nitrosoureas, mitomycin, or suramin).
  Endocrine Therapy: More than 4 weeks since hormonal therapy.
  Radiotherapy:
  No prior radiotherapy for newly diagnosed disease.
  No prior abdominal or pelvic radiotherapy.
  More than 4 weeks since radiotherapy for recurrent disease. No prior radiotherapy for locally advanced disease after resection allowed.
  Surgery:
  Prior resection allowed.
  Biliary decompression or gastric bypass allowed.
  PATIENT CHARACTERISTICS:
  Age: 18 and over.
  Performance status: ECOG 0-2.
  Hematopoietic:
  ANC greater than 2,000/mm(3).
  Platelets greater than 100,000/mm(3).
  Hepatic: AST/ALT no greater than 2.5 times normal.
  Renal:
  Creatinine less than 1.5 mg/dL.
  Creatinine clearance at least 60 mL/min,
  Cardiovascular:
  No myocardial infarction within 6 months.
  No unstable angina.
  No congestive heart failure (NYHA class III/IV).
  OTHER:
  HIV seronegative.
  No medical or psychiatric contraindication to protocol therapy.
  No concurrent malignancy other than: Skin cancer, Cervical carcinoma in situ.
  No pregnant or nursing women.
  Adequate contraception required of fertile patients.

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Positional Cloning of the Gene(s) Responsible for Alagille Syndrome

Summary: The goal of the project is to identify and clone the gene(s) responsible for the Alagille Syndrome (AGS) by a positional cloning approach. The first step towards this goal is to define the smallest genomic candidate region for AGS at 20p12 and to begin to identify genes within this region which are, by definition, candidate genes for the disease. In a collaborative effort with clinician-investigators studying the Alagille syndrome, metaphase chromosomes and genomic DNA from affected individuals will be studied for subchromosomal deletions and for mutations in the candidate genes. Characterization of genes involved in Alagille syndrome could provide important insight into the pathophysiology of the disease, the development of normal liver and treatment of this disease. Recently, we and others found that mutations in Jagged1, a Notch1 receptor are responsible for Alagille Syndrome.

Detailed description: The goal of the project is to identify and clone the gene(s) responsible for the Alagille Syndrome (AGS) by a positional cloning approach. The first step towards this goal is to define the smallest genomic candidate region for AGS at 20p12 and to begin to identify genes within this region which are, by definition, candidate genes for the disease. In a collaborative effort with clinician-investigators studying the Alagille syndrome, metaphase chromosomes and genomic DNA from affected individuals will be studied for subchromosomal deletions and for mutations in the candidate genes. Characterization of genes involved in Alagille syndrome could provide important insight into the pathophysiology of the disease, the development of normal liver and treatment of this disease.

Eligibility: All enrolled affected subjects, whose samples will be analyzed in this study, must meet the criteria for the clinical diagnosis of Alagille Syndrome (Syndromic Bile Duct Paucity) which include liver biopsy findings consistent with Alagille Syndrome and at least 3 of the 5 primary clinical criteria: cholestasis, characteristic face, posterior embryotoxon, "butterfly" vertebrae and cardiac findings.

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Computer Planned Radiation Therapy in Treating Patients With Prostate Cancer

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Computer systems that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment may result in more effective radiation therapy.
  PURPOSE: This phase II trial is studying how well radiation therapy that has been planned with a computer works in treating patients with prostate cancer.

Detailed description: OBJECTIVES:
  -  Establish the efficacy of high-dose three-dimensional conformal radiotherapy in patients with intermediate prognostic risk adenocarcinoma of the prostate.
  -  Determine the PSA relapse-free survival rate of this patient population.
  OUTLINE: Patients receive high-dose three-dimensional conformal radiotherapy 4-5 days per week for at least 9 weeks.
  Patients are evaluated at least weekly during radiotherapy and at 2 and 4 months after treatment completion. Thereafter, patients are followed every 6 months for a total of 3 years.
  PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven intermediate prognostic risk (T1-T2) adenocarcinoma of the prostate
  -  Previously untreated (except for hormonal therapy)
  -  PSA levels greater than 10 ng/mL and Gleason scores no greater than 6 OR
  -  PSA levels no greater than 10 ng/mL and Gleason scores at least 7
  -  Patients requiring volume reduction of prostate prior to radiotherapy continue to be treated at least 3 months on neoadjuvant hormonal therapy prior to radiation
  -  No evidence of distant metastases
  -  No regional lymph node involvement
  PATIENT CHARACTERISTICS:
  Age:
  -  Not specified
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  No major medical illness
  -  No psychosis
  -  No metallic pelvic prosthesis
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  No prior chemotherapy
  Endocrine therapy:
  -  See Disease Characteristics
  -  Prior neoadjuvant antiandrogen therapy allowed
  Radiotherapy:
  -  No prior radiotherapy
  -  No prior pelvic irradiation
  Surgery:
  -  No prior radical surgery for carcinoma of the prostate

Relevance to patient case: not relevant