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

Clinical trial: Efficacy Study of Intra-hepatic Administration of Therasphere® in Association With Intravenous Chemotherapy to Treat Cholangiocarcinoma

Summary: The purpose of this study is to assess efficacy and tolerance of intra-hepatic administration of Yttrium 90-labelled microsphere (Theraspheres®, Nordion) in association with intravenous chemotherapy with Gemcitabin and Cisplatin for the treatment of intra-hepatic cholangiocarcinoma.


Eligibility: Inclusion Criteria:
  1. Histologically confirmed intra-hepatic cholangiocarcinoma.
  2. Measurable target of at least 2 cm diameter.
  3. Healthy liver or cirrhosis CHILD < B8.
  4. WHO-PS: 0-1.
  5. Age ≥ 18 years.
  6. Non-Metastatic disease in extra-hepatic (are permitted: local lymph nodes < 3 cm, less than 5 lung nodes < 11 mm).
  7. Creatinine clearance (calculated with Cockcroft and Gault formula) ≥ 55 ml/min, polymorphonuclear neutrophils ≥ 1500 G/L, platelets ≥ 80 G/L, prothrombin ≥ 40% (INR ≤ 2.3), serum albumin ≥ 28 g/l, serum bilirubin ≤ 3 x LSN.
  8. Pregnancy test: negative for women of childbearing potential.
  9. Reliable contraception for a childbearing couple, men and woman must have an reliable contraception during the treatment and until 6 months following the end of the treatment by chemotherapy
  10. Signed informed consent form.
  11. Patient with national health insurance.
  Exclusion Criteria:
  1. Pancreas cancer or duodenum cancer invading the bile duct or ampullary cancer. Cholangiocarcinoma of the bile ducts: hilar, main duct, gallbladder.
  2. Extra-hepatic metastasis (including local lymph nodes measuring > 30 mm).
  3. Primary sclerosing cholangitis.
  4. History of chemoembolization or radioembolization.
  5. Cirrhose CHILD > B7
  6. Portal vein trunk tumoral thrombosis
  7. History of hepato-biliary neo adjuvant or palliative chemotherapy and/or radiotherapy.
  8. Contra indication of Gemcitabine and/or Cisplatin.
  9. Other invasive active cancer, excepting in situ cervical cancer and basocellular or spino cellular skin cancer treated adequately. Any history of cancer not considered as completely cured for at least one year.
  10. Technical failure of the diagnostic arteriography.
  11. Extra hepatic uptake on the pre-therapeutic scintigraphy not manageable with an arteriography.
  12. Dosimetry study predicting lung exposure > 30 Gy.
  13. Any unstable medical history (diabetes, hypertension …).
  14. History of organ transplant.
  15. Symptomatic grade 1 angina pectoris or grade ≥ 2 angina pectoris.
  16. An evolutive neuropathy.
  17. Patient who already has been involved in a clinical trial with drug intake, whether this drug was experimental or not, within 30 days before.
  18. Pregnant patient or patient with breastfeeding.
  19. Patient under administrative supervision.
  20. Regular follow-up impossible for various reasons (psychological, familial, economical, and social).

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

Clinical trial: Prognosis of Resection and Radiotherapy in the Treatment of Intrahepatic Cholangiocarcinoma Patients

Summary: The purpose of this study is to confirm that prognosis of Intrahepatic Cholangiocarcinoma (ICC) with resection and radiotherapy ,to find which is safe and effective treatment.

Detailed description: Intrahepatic Cholangiocarcinoma (ICC), the second most common primary liver cancer and constitutes 10% of primary liver malignancies.
  Current therapies for the treatment of ICC are ineffective and the role of liver transplantation is not well defined.
  This study reviews our experience with this tumor and looks for preoperative and pathologic indices that may help determine long term prognosis

Eligibility: Inclusion Criteria:
  -  Male or female patients > 17 years and <=60 years of age. confirmed case (patients with ICC) Tumors can be radical removed and resection volume was ≤50%. Criteria of liver function: Child A level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
  No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. Hbg ≥ 90g/L, WBC ≥ 3.000 cells/mm³,platelets ≥ 80.000 cells/mm³.
  Karnofsky Performance Score performance over 60. Patients who can understand this trial and have signed information consent.
  Exclusion Criteria:
  -  Patients who have undergone previous treatment by Resection or Radiotherapy. Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction, which may affect the treatment of liver cancer.
  Patients with other diseases which may affect the treatment mentioned here. Patients with medical history of other malignant tumors. Subjects participating in other clinical trials. Extrahepatic metastasis, portal vein or other major vascular involvement. liver function: Child B C.
  Patients would not sign the consent to the trial.

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 Intrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway

Summary: The investigators study the VEGF signaling in ICC cell lines／human tissues and its mechanism in HCC growth, proliferation and apoptosis.

Detailed description: Several studies have documented the elevated expression of VEGF and its receptors in ICC cell lines and tumor tissues. Another study observed that the elevation of VEGF promotes the growth. 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 ICC cells and its possible mechanism in regulating ICC growth.Therefore,we try to clarify the mechanism of VEGF signal in ICC growth,proliferation and apoptosis.

Eligibility: Inclusion Criteria:
  1. hepatocellular patients diagnosed through biopsy;or either dynamic imagine with a diagnosis of intrahepatic cholangiocarcinoma and CA199＞100U/L；or two or more dynamic imagine with a diagnosis of intrahepatic cholangiocarcinoma
  2. Child-Pugh A or B
  3. well preserved renal and hematopoietic Function
  4. receive complete surgical therapy
  5. achieve complete section accessed by contrast-enhanced CT
  Exclusion Criteria:
  1. incomplete section
  2. Child-Pugh C
  3. combination with other hepatobiliary disease
  4. 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: Androgen Regulation of Priapism in Sickle Cell Disease

Summary: It is believed that when androgen (testosterone) levels are below normal there is a disturbance of normal bodily functioning that is associated with priapism in some men. Conversely, it is believed that testosterone replacement will improve the condition of priapism when the testosterone levels are brought to normal. In turn, this will also improve psychological well being in men with sickle cell disease (SCD).

Detailed description: The central hypothesis of this proposal is that a decline in androgen levels results in decreased action and contributes to the molecular derangements associated with priapism. Optimizing androgen status may promote regulatory molecular mechanisms that protect against priapism. This clinical trial will investigate the potential benefit of precise testosterone replacement for ameliorating priapism and improving psychological well-being in hypogonadal men with SCD.
  This clinical trial aims to evaluate the efficacy of testosterone replacement therapy on the frequency of recurrent priapism in patients with SCD. The sub-hypothesis that testosterone (T) replacement to achieve serum T concentrations at a target range reduces recurrent priapism will be tested. This aim will involve subjective and objective assessments of priapism occurrences and erectile ability including priapism inventory instruments, standardized questionnaires of erectile function (EF) and quality of life, and Rigiscan™ erection monitoring in a 3.5-month pilot investigation.

Eligibility: Inclusion Criteria:
  -  Ages 18-50
  -  History of SCD
  -  Episodes of prolonged penile erection in the absence of sexual interest or desire, with an average frequency of at least twice weekly, when averaged over the previous four weeks
  -  serum testosterone level below 550 ng/dl
  -  Ability to provide informed consent
  Exclusion Criteria:
  -  Alcohol use exceeding two standard drinks daily
  -  Prostate conditions including prostate specific antigen (PSA) elevation (>2.5 ng/ml)
  -  Known sleep apnea
  -  Known cirrhosis
  -  Enlarged and painful male breasts

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

Clinical trial: S-1 in Combination With Abraxane in Treating Cholangiocarcinoma

Summary: This phase II study was designed to evaluate the efficacy and safety of S-1 plus Abraxane as second-line treatment for cholangiocarcinoma.

Detailed description: There are no standard second-line treatment for cholangiocarcinoma, new therapies are needed. The efficacy of S-1 as first-line treatment for cholangiocarcinoma was confirmed in several studies. The IMPACT study showed that Abraxane plus gemcitabine provide better survival than gemcitabine alone. Since cholangiocarcinoma displayed similar sensitivity to chemotherapy which was used in pancreatic carcinoma, we assume that S-1 plus Abraxane is effective and safe in treating cholangiocarcinoma.

Eligibility: Inclusion Criteria:
  -  Histologic or cytologic diagnosis of cholangiocarcinoma
  -  Not eligible for curative surgery
  -  Progressed after first-line gemcitabine-based chemotherapy
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better
  -  No serious or uncontrolled concomitant medical illness
  -  Adequate bone marrow function (absolute neutrophil count ≧1,500 ul, platelet count ≧90,000/ul), hemoglobin: > or equal to 8 mg/dL, total bilirubin: < or equal to 1.5 X institutional upper limit of normal, calculated creatinine clearance greater than or equal to 60 mL/min (calculated by the Cockcroft and Gault method).
  Exclusion Criteria:
  -  Uncontrolled infection or severe active comorbid disease
  -  Previous malignancy in the past five years, excluding nonmelanoma skin cancers and in situ cervical, bladder or uterine cancer
  -  Pregnancy or lactating women

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

Clinical trial: Prostate Screening Study Using MRI in BRCA Carriers

Summary: Men with a BRCA1 or BRCA2 mutation are at increased risk for early onset, aggressive prostate cancer compared to men in the general population.
  Standard of care screening for men with a BRCA mutation includes PSA testing and digital rectal examination (DRE), the same as with men in the general population.
  This study is being done to assess whether there is value in using MRI as a screening tool to detect prostate cancer at an earlier stage than may otherwise be detected using standard of care screening (PSA, DRE). It is unclear whether MRI has utility as a screening tool in this specific population at high risk for aggressive disease.

Detailed description: To determine the value of using Multispectral 3T MRI (MS3TMRI) for prostate cancer screening in men with a high risk of developing early onset aggressive prostate cancer given known BRCA1 or BRCA2 mutation carrier status, with no prior prostate cancer diagnosis, independent of baseline PSA levels.
  -  Determine the prevalence of prostate cancer in BRCA1 and BRCA2 mutation carriers independent of baseline PSA levels.
  -  To evaluate the accuracy of tumor targeting based on MRI and ultrasound (US) tumor co-localization. To evaluate the sensitivity, specificity, PPV, NPV, and accuracy of an automated computer aided diagnosis method (CAD) applied to MS3TMRI in the prediction of zonal biopsy results for the presence or absence of a significant cancer.

Eligibility: Inclusion Criteria:
  -  Enrolled in the Male Hereditary Cancer Research Program at Sunnybrook Health Sciences Center.
  -  Have positive genetic testing for a pathogenic BRCA1 or BRCA2 mutation.
  -  Clinically eligible for and willing to undergo ultrasound biopsy within 4 weeks after the MRI.
  -  Be 50 years of age or older.
  Exclusion Criteria:
  -  Claustrophobia
  -  Contraindication to MRI
  -  Contraindication to receiving low molecular weight MRI contrast agent
  -  Previously diagnosed with prostate cancer

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 Breast Cancer Susceptibility: A Pilot Study of Subject Preferences for Information and Responses After Testing

Summary: The purpose of this study is to find out what kinds of information people would like to receive from a new kind of genetic testing, and how they respond to this new kind of testing.


Eligibility: Inclusion Criteria:
  -  Male or Female age 18 or older
  -  Personal history of breast cancer AND one of the following:
  -  Invasive breast cancer or DCIS diagnosed at or before age 45 Invasive breast cancer diagnosed at/before age 50 with one or more of the following:
  -  Limited family history (Fewer than 2 first- or second-degree female relatives in the same lineage that lived to age 45. The "limited family history" can occur on either the maternal or paternal side of the family.)
  -  1 or more first-/second-degree relatives with invasive BC at/before 50
  -  1 or more first-/second-degree relatives with invasive epithelial ovarian cancer (any age)
  -  1 or more first- or second-degree relatives with male breast cancer
  -  2 or more first- or second-degree relatives with pancreas cancer
  -  Invasive breast cancer diagnosed at or before age 60 with at least 2 first or second-degree relatives affected with any combination of invasive breast cancer before age 50, invasive epithelial ovarian cancer at any age, male breast cancer, or pancreas cancer.
  -  Full sequence BRCA1 and BRCA2 testing completed with no deleterious mutation identified.
  Exclusion Criteria:
  -  Unable to provide informed consent for testing
  -  Unable to complete English language questionnaire

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

Clinical trial: The Cancer of the Pancreas Screening-5 CAPS5)Study

Summary: Johns Hopkins clinical research office quality assurance group will monitor and audit this study at Johns Hopkins. The Sub Investigator at each site will be responsible for internal monitoring at their site.

Detailed description: The Sub Investigator at each site will be responsible for internal monitoring at their site. The site sub Investigator and study team will report any serious adverse events to Principal Investigator and annually report adverse events.

Eligibility: Inclusion Criteria:
  -  Hereditary Pancreatitis or
  -  Peutz-Jeghers Syndrome or
  -  Strong family history of pancreas cancer on one side of the family tree or
  -  Confirmed germline mutation carrier (BRCA2, FAMMM, PALB2, BRCA1, HNPCC, PRSS1/2, or CTRC
  -  Endoscopic evaluation of pancreas scheduled
  Exclusion Criteria:
  -  Medical comorbidities or coagulopathy that contraindicate endoscopy
  -  Prior surgery that prevent optimal endoscopic ultrasound such as partial or complete gastrectomy with Bilroth or Roux-en-Y anastomosis
  -  Stricture or obstruction in the upper GI tract that does not allow passage of the echoendoscope
  -  Poor performance status
  -  Inability to provide informed consent
  -  Pregnancy.

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

Clinical trial: Diagnosis of Bile Duct Strictures

Summary: The purpose of this prospective study is to compare the diagnostic utility of two techniques (brush cytology + FISH and brush cytology + free DNA analysis) in the diagnosis of biliary strictures. Histologic diagnosis (biopsies) in conjunction with clinical and/or imaging follow-up will serve as the gold standard for diagnosis of malignancy. In order to do this the investigators will ask study participants to have a small volume of fluid obtained from the bile duct sent for additional testing at RedPATH. In some patients additional brushings will be obtained for FISH testing (this adds <2 minutes to ERCP and only associated risk is increased procedure duration).
  The investigators hypothesize that the use of cytology +DNA analysis has a higher sensitivity and accuracy when compared to cytology +FISH in patients with biliary strictures.
  Primary aim:
  To compare the sensitivity and accuracy of the two techniques (brush cytology + FISH and brush cytology + free DNA analysis). Histologic diagnosis (histology from biopsy or cytology for fine needle aspiration) in conjunction with clinical and/or imaging follow-up will serve as the gold standard for diagnosis of malignancy.
  Secondary aims:
  1. To evaluate the diagnostic yield of malignancy when all three techniques (cytology, FISH and DNA analysis) are used.
  2. To evaluate the added value of biliary forceps biopsies, when used in conjunction with cytology, FISH and DNA analysis.


Eligibility: Inclusion Criteria:
  1. Patients age: > 18 years
  2. Presence of a biliary stricture
  3. Ability to provide written informed consent.
  Exclusion Criteria:
  1. Severe coagulopathy (INR > 1.8) or thrombocytopenia (platelet count <50,000)
  2. Inability to cannulate the common bile duct
  3. Presence of altered anatomy (Billroth II or Roux-en-Y reconstruction)

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

Clinical trial: Etomidate vs. Midazolam for Sedation During ERCP

Summary: Recently up-coming drug, etomidate which is a modulator of GABA(gamma-Aminobutyric acid)-A receptor has been known that it maintains the appropriate sedative levels and affects little effects on respiratory system.
  The investigators are now trying to investigate that etomidate with meperidine combination regimen is superior to the midazolam with meperidine more effective and less harm on sedation during the ERCP procedure.

Detailed description: ERCP (Endoscopic retrograde cholangiopancreatogram) is an uncomfortable and time-consuming procedure compared to other endoscopic procedures. Most ERCP procedure had been performed in sedation using tranquilizers and pain-killers.
  Until recently, midazolam and opioid combination regimen recognized as a standard therapy is widely used, but the sedative effect is insufficient and intermittent paradoxical reaction has been questioned. Another drug, such as propofol, has been known that the sedative effect is superior one of the midazolam but disappointed due to narrow therapeutic range of respiratory distress and absence of antagonist. Meanwhile, recently up-coming drug, etomidate which is a modulator of GABA-A receptor has been known that it maintains the appropriate sedative levels and affects little effects on respiratory system.
  For these advantages, this short acting sedative drug has been widely used in the emergency room during minor operation and in the operation room for induction. However, research on the efficacy during ERCP was not yet published.
  In this regards, the purpose of the investigators study is to prove the efficacy of etomidate for sedation and to establish new evidence based sedation guidelines during ERCP procedure.

Eligibility: Inclusion Criteria:
  -  All patients who are scheduled diagnositic or therapeutic ERCP.
  -  Age : more than 20 and less than 90 years old
  -  ASA(American Society of Anesthesiologists) classificiation : I, II, III
  Exclusion Criteria:Patients following
  -  Refuse to be enrolled
  -  ASA American Society of Anesthesiologists)classification IV, V
  -  Breast feeder
  -  The mentally ill
  -  Drug abuser
  -  Hypersensitivity to sedative or opioids
  -  Alcohol intoxication or dependency
  -  Body mass index (BMI) 36kg/m2 or more
  -  Unstable vital sign
  1. tachypnea, respiration rate more than 25/min or less than 10/min
  2. Oxygen saturation : 90% or less
  3. Systolic blood pressure : less than 90 mmHg or more than 180 mmHg
  4. Diastolic blood pressure : less than 50 mmHg or more than 100 mmHg
  5. Heart rate : more than 120 beat/min or less than 50 beat/min.

Relevance to patient case: not relevant