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

Clinical trial: BRCA1 and BRCA2 Mutation in Romanian Population: a Study of Genotype - Phenotype Correlation at Diagnosis With Prospective Disease Outcome and Survival

Summary: Primary objective To determine BRCA1 and BRCA2 variants in 250 Romanian women with breast/ovarian cancer selected for likeliness to harbor germline mutations in these genes by specific criteria for high-risk status including age at disease onset.
  Secondary objective Considering the fact that BRCA testing is not a routine procedure in Romania and mutation prevalence varies in different populations, we intend to look for the founder mutation in our population, running full BRCA genes sequencing to a representative population sample. This would allow a more targeted approach to real-life practice and would ensure personalized solutions for every patient in need.


Eligibility: Inclusion Criteria:
  Categories of patients to be recruited for complete sequencing of all BRCA1 and BRCA2 exons are subjects who have been diagnosed with breast or ovarion cancer and who are:
  1)40 years of age or younger 2)Triple negative breast cancer diagnosed before 50 years of age 3)Male with breast cancer 4)Bilateral breast cancer, first tumor diagnosed before 50 years of age 5)2) + 50 years of age or younger with at least one (first degree) relative diagnosed with breast cancer at 50 years of age or younger or a first degree relative with ovarian cancer 6)of any age with 2 or more relatives with breast cancer 7)of any age with 2 or more relatives with ovarian cancer 8)of any age with a personal history of ovarian cancer, tuba or peritoneal carcinoma 9)Two patients in same branch of the family, Prostate ca < 60 yr and 1st degree relative with BC < 50 yr 10)Two or more 1st and 2nd degree relatives of a patient with breast cancer, at least one of them <50 yr 11)of any age with a family history of male breast cancer or are at increased risk of having a BRCA mutation based on BRCAPRO or Tyrer-Cuzick models
  Exclusion Criteria:

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

Clinical trial: Rate of Duodenal-biliary Reflux Increases in Patients With Recurrent Common Bile Duct Stones

Summary: ERCP is the primary choice for removal of common bile duct stone (CBDS) currently. However, 4-24% patients underwent recurrence after successful clearance of CBDS. Stone re-formation due to chronic inflammation of biliary duct is generally considered an important cause of CBDS recurrence, which is associated with duodenal-biliary reflux (DBR) after sphincterotomy. Although it was believed that DBR was the important cause of CBDS recurrence, the direct evidence was still lacking. Here we conducted a case control study to investigate the DBR rate in patients with recurrent CBDS after ERCP.


Eligibility: Inclusion Criteria:
  -  Patients with common bile duct stone underwent successful stone removal by ERCP in Xijing Hospital of Digestive Diseases.
  Exclusion Criteria:
  -  Gallbladder stones or hepatolithiasis;
  -  Stenosis of biliary duct;
  -  Incomplete common bile duct stone removal by ERCP;
  -  Common bile duct stent;
  -  Unable to provide informed consent.

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

Clinical trial: Hyper-Thermia Enhanced Anti-tumor Efficacy of Trabectedin

Summary: This trial compares trabectedin alone to trabectedin in combination with regional hyperthermia in patients with high-risk soft tissue sarcoma. The study is designed to demonstrate a significant benefit for sarcoma-therapy by adding regional hyperthermia.


Eligibility: Inclusion Criteria:
  -  Age > 18 years
  -  Histologically confirmed STS (primary or recurrent), except: Ewing sarcoma, osteosarcoma, skeletal chondrosarcoma (extraskeletal chondrosacomas are included), GIST, dermatofibrosarcoma protuberans, malignant mesothelioma, rhabdomyosarcoma
  -  Patients after failure of first-line chemotherapy (anthracyclines and ifosfamide) with or without RHT
  -  Progressive or recurrent tumor which is unresectable or only resectable with adverse functional outcome
  -  After macroscopic incomplete resection or marginal resection (tumor-free margins < 1 cm)
  -  Prior chemotherapy, including anthracyclines and ifosfamide (with or without RHT) or patients who cannot be given these medicines
  -  Oligometastasis (≤ 5 lesions)
  -  Performance status (ECOG) 0,1 or 2
  -  More than 3 weeks from last treatment
  -  Neutrophil count > 1,5 G/l, hemoglobin > 9 g/dl, platelets > 100 G/l
  -  Albumin > 25 g/l, total bilirubin < 1 x ULN, ALT/AST < 2.5 x ULN, AP < 2.5 x ULN, Cockroft and Gault's calculated creatinine clearance > 30 ml/min, CPK < 2.5 x ULN
  -  Patients with the ability to follow study instructions and likely to attend and complete all required visits
  -  Written informed consent of the subject
  Exclusion Criteria:
  -  Uncontrolled infection (e.g. active viral hepatitis)
  -  Unstable cardiac status
  -  Peripheral neuropathy > grade 2
  -  Known or persistent abuse of medications, drugs or alcohol
  -  Other malignancy during the last 5 years (exclusion of basal cell carcinoma or adequately treated cervical carcinoma in situ)
  -  Prior therapy with Tr or known history of hypersensitivity to drugs with a similar chemical structure
  -  Pregnancy or breast-feeding
  -  Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration
  -  Uncontrolled CNS-metastases
  -  Medical or technical impossibility for hyperthermia to heat the major target lesion

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

Clinical trial: 18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant

Summary: This clinical trial studies fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) positron emission tomography (PET) in imaging patients with liver cancer before undergoing surgery or transplant. Diagnostic procedures, such as 18F-FSPG PET, may help find and diagnose liver cancer and find out how far the disease has spread.

Detailed description: PRIMARY OBJECTIVES:
  I. To evaluate the relationship between 18F-FSPG PET/computed tomography (CT) and pathology in patients with suspected hepatocellular carcinoma (HCC) scheduled for liver resection surgery and orthotopic liver transplant (OLT).
  II. To compare 18F-FSPG PET/CT with standard-of-care (SOC) diagnostic CT imaging in patients with suspected HCC scheduled for liver resection surgery or OLT.
  III. To compare the uptake of 18F-FSPG PET/CT with 11C-acetate PET/CT in suspected HCC and background liver in patients scheduled for liver resection surgery or OLT.
  IV. To evaluate uptake of 18F-FSPG PET/CT in non-HCC liver tumors: benign and malignant compared to background.
  OUTLINE:
  Patients undergo 18F-FSPG PET and carbon-11 (11C)-acetate PET scans within 4-8 weeks of surgery or OLT.

Eligibility: Inclusion Criteria:
  -  Diagnosis of HCC with clinically documented cirrhosis and one or more of the following:
  -  Liver mass (>= 1 cm) with arterial phase contrast enhancement and early washout on subsequent phases by CT; or
  -  Suggestive imaging findings plus alpha-feto protein (AFP) > 200 mg/dL; or
  -  Tumor confirmed by arteriography -or-
  -  Diagnosis of a non-HCC liver mass with one or more of the following:
  -  Liver mass (≥ 1 cm) that has suggestive imaging findings of a benign liver mass (adenoma, hemangioma, focal nodular hyperplasia).
  -  Liver mass (≥ 1 cm) that is biopsy proven metastatic disease (metastatic colorectal cancer, metastatic pancreatic cancer).
  -  Liver mass (≥ 1 cm) that is a non-HCC primary malignancy (cholangiocarcinoma). -and-
  -  Each patient must provide written informed consent and have completed conventional imaging and staging and CT (multiphase) or MRI before initiation of the investigational PET studies
  Exclusion Criteria:
  -  Patients with a known prior malignancy who have received systemic chemotherapy within five years, except basal cell carcinoma of the skin, carcinoma in situ of the cervix, prior HCC, and patients with liver mass(es) proven to be metastatic disease are excluded.
  -  Pregnant and breastfeeding patients
  -  Patients with poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL)
  -  Patients with a known infiltrative variant of HCC

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

Clinical trial: Early Versus Late Cholecystectomy After Clearance of Common Bile Duct Stones

Summary: Approximately 10-15% of all patients with gallstones have coexisting common bile duct (CBD) stones. However CBD stones can also be formed in the absence of gallbladder stones. The current standard of treatment for calcular obstructive jaundice is endoscopic removal of the stones. Endoscopic sphincterotomy (ES) is widely accepted as the treatment of choice for patients with CBDS. Stone extraction is successful in up to 97% of patients The time interval between ERCP and laparoscopic cholecystectomy (LC) is a matter of debate that may vary from days to months. Some retrospective and other prospective studies have investigated this issue without sharp clue or definite conclusion This study planned to compare early LC (within admission) versus late LC (after 1 month) after ERCP as regard technical difficulties and surgical outcomes.

Detailed description: The aim is comparing early versus delayed laparoscopic cholecystectomy after endoscopic retrograde cholangiopancreatography in patients with gall bladder stones and calcular obstructive jaundice as regards operative difficulties, conversion rate, signs of inflammation, degree of adhesions, blood loss, postoperative morbidity, and hospital stay. Moreover, bacterial examination of bile and culture sensitivity test for assessment of bacterial colonization and relate the degree of colonization to timing of laparoscopic cholecystectomy after endoscopic retrograde cholangiopancreatography, to decide upon the optimal timing for the surgery.
  The study population will be divided into 2 groups; group (A) will be managed by early laparoscopic cholecystectomy (LC) within 3 days after ERCP and group (B) will be managed by late LC one month after ERCP.

Eligibility: Inclusion Criteria:
  -  Patients with CBD stone and treated by ERCP
  Exclusion Criteria:
  -  Patient unfit for surgery,
  -  Pregnant patients,
  -  Patients with severe malnutrition,
  -  Patients with liver cirrhosis,
  -  Patients in whom endoscopic management of CBD stones failed
  -  Patients who experienced pancreatitis or perforation as a complication of the endoscopic management of CBD stones
  -  Patients who underwent previous upper abdominal surgeries
  -  Mentally retarded patients.

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

Clinical trial: Integrative Approach to Identify Environmental Risk Factors for CC-17 Group B Streptococcal Neonatal Infection

Summary: Streptococcus agalactiae (GBS) is the leading cause of neonatal septicaemia, meningitis, and pneumonia in the industrialized world. Early onset (EOD) and late onset (LOD) diseases are defined in neonates by their occurring within or after the first week of life, respectively. Molecular epidemiological studies have identified a capsular serotype III clone, referred to as CC-17 by Multi Locus Sequence Typing, as accounting for the vast majority of neonatal invasive diseases and for almost all cases of meningitis in LOD.
  The investigators working hypothesis is that host-environmental interactions may contribute to the colonization and persistence of the hypervirulent CC-17 GBS in the neonate. In this project the investigators will determine if reciprocal interactions between the intestinal microbiota and the innate and adaptive immune system may specifically facilitate the colonization of the neonate by the hypervirulent GBS CC-17 clone.

Detailed description: Four specific tasks will be addressed to:
  (i) Understand whether and how the gut microbiota may influence growth and colonization of GBS CC-17 within the intestine of neonates.
  (ii) Study the contribution of different diets and immune system constituents enabling the persistence of GBS CC-17 in the gut of neonates.
  (iii) Determine whether the adaptive immune response elicited by maternal GBS colonization and transmitted to the infant is different for GBS CC-17 versus non-CC-17 GBS.
  (iv) Determine whether or not GBS strains isolated from the mothers and from their babies are identical and whether the environment (ie. the vagina or the milk for the mother, the intestine or the oral cavity for the baby) influence the expression of specific virulence factors of CC-17.

Eligibility: Inclusion criteria:
  -  Patient having a negative vaginal swab for GBS at 35-37 weeks
  -  Patient aged over 18 years
  -  Patient who received information and agreeing to sign informed consent
  -  Patient affiliated or beneficiary of an insurance
  Exclusion criteria:
  -  Patient does not speak and does not understand French

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

Clinical trial: The Link Between BRCA Mutation and Endothelial Function

Summary: This study evaluates the effect of BRCA1&2 mutations on cardiovascular diseases by to comparing the endothelial function of male BRCA mutation carriers with that of age matched non-BRCA mutation carriers.


Eligibility: Inclusion Criteria:
  -  Known carrier or non-carrier, confirmed by genetic testing of BRCA 1/2 mutation
  -  Able and willing to sign an informed consent
  Exclusion Criteria:
  -  History of, or current, malignancy
  -  History of:
  -  Myocardial infarction
  -  Ischemic or Hemorrhagic cerebrovascular conditions
  -  Arterial embolic and thrombotic events
  -  Ischemic heart disease
  -  Prior coronary artery or ilio-femoral artery revascularization (percutaneous or surgical procedures)
  -  Peripheral vascular disease (e.g. claudication, prior vascular surgery/intervention)

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

Clinical trial: Biliary Cannulation During Endoscopic Retrograde Cholangiopancreatography: Precut Versus Conventional Cannulation

Summary: Endoscopic sphincterotomy is now an established method for removal of common bile duct calculi and treatment of papillary stenosis, the sump syndrome and certain cases of ampullary carcinoma. It is also generally performed prior to biliary stent placement .Anatomical variations, papillary stenosis, impacted stones, ampullary tumors, duodenal diverticula, and post-gastrojejunostomy states are some of the reasons behind difficult common bile duct (CBD) cannulations . In these situations, the success of CBD cannulation can be enhanced slightly by using the various accessories designed for this purpose.The aim of this study is to prospectively compare conventional approach and needle knife fistulotomy in cannulation of ampulla of Vater during endoscopic retrograde cholangiopancreatography regarding procedure-related complications as failure of cannulations, bleeding and perforation and postoperative complication

Detailed description: The aim of this study is to prospectively compare conventional approach and needle knife fistulotomy in cannulation of ampulla of Vater during endoscopic retrograde cholangiopancreatography regarding procedure-related complications as failure of cannulations, bleeding and perforation and postoperative complication This a prospective randomized controlled trial comparing two groups of patients who undergo endoscopic retrograde cholangiopancreatography for obstructive jaundice in Gastrointestinal Surgical center, Mansoura University, Egypt. From January 2014 to December 2014.
  Group A consists of 50 patients who will undergo conventional approach and group B consists of 50 patients who undergo needle knife fistulotomy for cannulation of the ampulla of Vater. Randomization was done by paramedical personnel in the ERCP unit by taking a number from an envelope.
  Data will be registered in a specially prepared sheet for the purpose of the study. Registered data will include: duration of cannulation, number of trials for cannulation, number of pancreatic cannulation, bleeding during cannulation and its management, need to convert to the other approach in cannulation.
  Data also included postoperative hospital stay, serum amylase level and postoperative complications as pancreatitis, perforation, bleeding and cholecystitis. Pancreatitis will be also graded according to its severity depending on the duration of hospital stay.

Eligibility: Inclusion Criteria:
  -  all patients (no limit of age) required ERCP calculator and malignant obstructive jaundice
  Exclusion Criteria:
  -  unfit patients history of gastrectomy bleeding tendency larg tumour infiltrating the duodenum

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 BIND-014 in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck

Summary: BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients with advanced urothelial carcinoma, cervical cancer, cholangiocarcinoma or carcinomas of the biliary tree and squamous cell carcinoma of the head and neck.
  Ferumoxytol imaging will also be investigated at US sites as an exploratory endpoint.


Eligibility: Inclusion Criteria:
  1. Diagnosis of advanced urothelial carcinoma, cervical cancer, cholangiocarcinoma or carcinomas of the biliary tree or squamous cell carcinoma of the head and neck.
  2. Progressive disease after ≥ 1 prior chemotherapy regimen.
  3. Patients with brain metastases are eligible if asymptomatic and neurologically stable for at least 4 weeks and are not taking any medications contraindicated
  4. Chemotherapy must have been completed at least 4 weeks prior to initiation of study medication
  5. ECOG performance status 0-1
  6. Tumors must have measurable disease as per RECIST (version 1.1);
  7. Female or male, 18 years of age or older
  8. Adequate organ function
  9. Life expectancy of > 3 months
  Exclusion Criteria:
  1. Current treatment on another therapeutic clinical trial
  2. Prior treatment with docetaxel within 6 months of enrollment
  3. Stage II, III or IV cardiac failure
  4. Carcinomatous meningitis
  5. Ongoing cardiac dysrhythmias
  6. Peripheral neuropathy
  7. Serious concomitant conditions
  8. Pregnant or breast feeding
  9. Known sensitivity to ferumoxytol
  10. Hypersensitivity to polysorbate 80

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

Clinical trial: Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma

Summary: The purpose of this study is to determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with cholangiocarcinoma.

Detailed description: The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with cholangiocarcinoma.

Eligibility: Inclusion Criteria:
  -  Patients with histologically confirmed cholangiocarcinoma
  -  Primary lesions (cholangiocarcinoma) are not resected
  -  Serum bilirubin level of 2.0 mg/dl or less.
  -  Performance status of 0 or 1.
  -  Expected survival of 1 year or more.
  -  Informed consent from the patient.
  Exclusion Criteria:
  -  With extrahepatic metastases
  -  With other neoplastic disease that is measurable or being treated other than cholangiocarcinoma.

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

Clinical trial: 90Y Transarterial Radioembolization (TARE) Plus Gemcitabine and Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma

Summary: The purpose of this study is to determine the safety and maximum tolerated dose (MTD) of 90 Y TARE (Y90) in combination with gemcitabine and cisplatin in patients with unresectable intrahepatic cholangiocarcinoma (ICC).


Eligibility: Inclusion Criteria:
  -  Histologic Documentation: Core needle biopsy or surgical specimen that confirms intrahepatic cholangiocarcinoma (ICC). Patients must be determined to be unresectable by a multidisciplinary team that includes a hepatobiliary surgeon.
  -  No prior liver radiation therapy or immunotherapy for cholangiocarcinoma.
  -  Only previous single agent chemotherapy for ICC allowed.
  -  Patient may have prior liver resection.
  -  Age > 18 years of age.
  -  Eastern Cooperative Oncology Group (ECOG) performance status < 2 (see Appendix E)
  -  Child's Pugh score of A (see Appendix F)
  -  Life expectancy of greater than 4 months
  -  Normal organ and marrow function as outlined in the protocol.
  -  Willingness to use effective contraceptive methods during the study. Patient may participate in the female (or female partner of male subject), either is not of childbearing potential (defined as postmenopausal for > 1 year or surgically sterile) or is practicing two forms of contraception. Sexually active male participants must agree to use a physical barrier method (male latex rubber condom with or without spermicide).
  -  Patients with well controlled HIV infection are eligible if their CD4 count is >499/cu mm and viral load is < 50 copies/ml.
  -  Pre-certification for the 90Y TARE should be performed prior to enrollment on this study.
  -  All patients must be informed of the investigational nature of this study and must have the ability to understand and the willingness to sign a written informed consent document.
  Exclusion Criteria:
  -  Patients who have had major surgery within 4 weeks prior to entering the study or those who have not recovered from complications from a surgery more than 4 weeks earlier.
  -  Patients may not be receiving any other investigational agents.
  -  Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association (NYHA) Criteria
  -  Patients must NOT have liver disease such as cirrhosis or sever hepatic impairment as defined by Child-Pugh Class B or C
  -  Pregnant women are excluded from this study.

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

Clinical trial: Multiplex Testing for Evaluation of Breast Cancer Risk, Longitudinal Study

Summary: The overall goal of the proposed research is to evaluate the uptake of testing and longitudinal risks and benefits of multiplex testing for cancer susceptibility in BRCA1/2 negative patients. This model will inform the selection of the outcomes and potential mediators and moderators of these outcomes, to inform the debate over utility, risks, and benefits of clinical incorporation of multiplex testing for breast cancer susceptibility.


Eligibility: Inclusion Criteria:
  -  1. Women and men (at least 18 YO) 2. English speaking AND 3. Negative for BRCA1 and BRCA2 mutations
  Exclusion Criteria:
  1. Non English speaking patients

Relevance to patient case: not relevant