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

Clinical trial: Acoustic Radiation Force Impulse Imaging (ARFI) in Patients After Liver Transplantation

Summary: Aims: Prospective evaluation of the applicability of acoustic radiation force impulse(ARFI) imaging to assess liver fibrosis in patients after orthotopic liver transplantation.
  Material and methods: We prospectively assess the performance of ARFI imaging in planned 100 patients after orthotopic liver transplantation. We evaluate shear wave velocity of the left and right liver lobe with the convex array (6C1HD)ultrasound transducer and compare the results with clinical data and B-mode criteria.
  ARFI elastometry is an increasingly popular non-invasive method for the assessment of hepatic fibrosis and cirrhosis. To date, ARFI technology has not been applied systematically in patients after orthotopic liver transplantation. Therefore we want to establish standard values in this population.


Eligibility: Inclusion Criteria:
  -  Patients after orthotopic liver transplantation.
  Exclusion Criteria:
  -  Patients without status after orthotopic liver transplantation.

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

Clinical trial: Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma

Summary: This study is being done to determine if targeted radiation therapy (stereotactic) can be given to treat liver cancer, for patient who are unable to undergo surgery, over a short period of time with a small amount of side effects.


Eligibility: Inclusion Criteria:
  -  Age ≥ 18
  -  Karnofsky Performance Status of ≥ 60
  -  Pathologically confirmed IHC or HCC. (Pathology not required for HCC if the lesion enhances typically on MRI and the patient is evaluated by liver transplant surgery team and thought to have HCC.)
  -  4 or less separate intrahepatic lesions, with at least one lesion that is able to be followed by EASL Criteria.
  -  Local surgical resection is not possible due to tumor or patient factors
  -  Limited metastatic disease is allowed if the volume of metastatic disease does not exceed the volume of primary disease.
  -  Prior TACE allowed if stopped/completed at least 2 weeks prior to enrollment
  -  Prior chemotherapy except Sorafenib allowed if stopped/completed at least 2 weeks prior to enrollment
  -  Prior Sorafenib allowed if stopped/completed at least seven days prior to enrollment.
  -  Able to provide signed informed consent
  Exclusion Criteria:
  -  Childs-Pugh score 9 or more
  -  ALT or AST ≥ 6 x upper limit of normal
  -  Prior history of abdominal irradiation
  -  Women who are pregnant or nursing
  -  Scheduled to undergo chemotherapy except Sorafenib at the time when radiation therapy will be given, or for up to 4 weeks after completion of radiation therapy.
  -  Scheduled to undergo Sorafenib within seven days of when radiation therapy will be delivered, or for up to 2 weeks after completion of radiation therapy.
  -  Undergone prior radiation therapy to the abdomen.

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

Clinical trial: Impact of Critical Limb Ischemia on Long Term Cardiac Mortality in Diabetic Patients Undergoing Percutaneous Coronary Revascularization

Summary: Prospective cohort study of consecutive diabetic patients undergoing percutaneous coronary intervention (PCI) in whom development of critical limb ischemia was prospectively assessed by a dedicated diabetic foot clinic. Cardiac mortality at 4-year follow-up was the primary endpoint of the study.


Eligibility: Inclusion Criteria:
  -  diabetes mellitus
  -  need for coronary revascularization
  -  age > 18 years
  Exclusion Criteria:
  -  clinical contraindications to prolonged double antiplatelet therapy
  -  life expectancy < 1 year
  -  lack of consent

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

Clinical trial: Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy

Summary: Pancreaticoduodenectomy is a surgical procedure for removing cancer in the pancreas, the bile system or the duodenum that is associated with a high rate of complications. The study wants to investigate whether a new technique to reconstruct the joint between the pancreatic gland and the short bowel can reduce the rate of severe complications after this complex surgical procedure.

Detailed description: Pancreaticoduodenectomy is a complex surgical procedure for radically resecting tumors in the pancreatic head, distal bile duct or duodenum. Postoperative pancreatic fistula is the main contributor of severe postoperative morbidity after pancreaticoduodenectomy. Characteristics of the pancreatic gland like soft pancreatic consistency and small pancreatic main duct predispose for the postoperative fistula development. In high risk patients, the risk of suffering from associated postoperative morbidity is 50 percent which is considered unacceptable high. The aim of the current trial is to investigate whether a new anastomosing technique for the pancreaticojejunostomy can reduce the incidence of associated postoperative morbidity in patients undergoing pancreaticoduodenectomy.

Eligibility: Inclusion Criteria:
  -  Patients scheduled for elective pancreaticoduodenectomy
  -  Pancreatic gland with high risk criteria for associated postoperative morbidity
  Exclusion Criteria:
  -  Patients do not accept participation
  -  Pancreatic gland with intermediate or low risk criteria for associated postoperative morbidity

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

Clinical trial: Endoscopic Biliary Radiofrequency Ablation of Malignant Distal Common Bile Duct Strictures

Summary: Malignant bile duct obstruction is a common sequela of pancreatic cancers or distal bile duct cancers, and its development can hinder the use of chemotherapy, decrease patient quality of life, and decrease survival. To relieve obstructive jaundice as a result of the obstruction, endoscopic stent placement is usually required. The use self-expandable metal stents (SEMSs) have been shown to result in a longer patency times as compared with plastic stents. However, despite improvements in materials and stent design, stent obstruction still occurs in 13% to 44% of the patients. Tumor in-growth is the most common mechanism of stent obstruction.
  Recently, the use of endoscopic biliary radiofrequency ablation (EBRFA) have been described in patients suffering from inoperable malignant distal common bile duct (CBD) obstruction. The procedure uses heat energy to cause local tumour tissue death, resulting in re-opening of the bile duct lumen. The procedure has the potential of reducing the rate of stent obstruction after SEMS and also prolonging survival. The safety profile appears to be comparable that of placement of SEMS alone without added complications (<10%). The aim of the current study is to compare the efficacy of EBRFA with the addition of SEMS to SEMS alone in a randomized controlled trial.We hypothesize that the application of EBRFA can reduce recurrent biliary obstruction after SEMS.


Eligibility: Inclusion Criteria:
  1. Age ≥ 18 years old with informed consent
  2. Histologically (preferred) or radiologically confirmed distal malignant bile duct tumors
  3. Inoperability by staging, comorbidities or patient wishes
  4. Distal tumors 2cm away from the portal hilum
  5. Bilirubin > 50umol/L at diagnosis
  Exclusion Criteria:
  1. Periampullary tumours
  2. Multiple hepatic metastases with significant blockage of one or more liver segments (if no segment blockage, metastasis is not an exclusion criteria)
  3. Presence of main portal vein thrombosis
  4. Prior SEMS placement
  5. Prior Billroth II or roux-en Y reconstruction
  6. History of bleeding disorder or use of anticoagulation
  7. Child's B/C cirrhosis
  8. Pregnancy
  9. Performance status ECOG ≥3 (confined to bed / chair > 50% waking hours)
  10. Presence of other malignancy
  11. Presence of gastric outlet obstruction
  12. Life expectancy < 3months

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

Clinical trial: Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma

Summary: The purpose of this study is to compare endoscopic radiofrequency ablation with photodynamic therapy for inoperable cholangiocarcinoma


Eligibility: Inclusion Criteria:
  -  Age ≥ 18 years old
  -  Pathologically or radiologically confirmed biliary malignant
  -  Inoperability by staging
  Exclusion Criteria:
  -  Cholangiocarcinoma with widespread metastasis
  -  Coagulopathy (INR > 2.0 or prothrombin time > 100 sec or platelet count < 50,000)
  -  Prior SEMS placement
  -  Pregnancy
  -  Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3 )
  -  Life expectancy < 3months

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

Clinical trial: Clinical and Histopathologic Characteristics of BAP1 Mutations

Summary: The goal of this protocol is to determine the prevalence of somatic and germline mutations in BAP1 (BRCA associated protein-1) among patients with mesothelioma , choroidal nevus, primary uveal melanoma (UM), or metastatic UM seen at our institution.


Eligibility: Inclusion Criteria:
  All consents:
  -  > or = to 18 years of age
  -  Ability to provide informed consent
  Consent 1:
  Mesothelioma
  -  Histologically proven diagnosis of Mesothelioma OR Choroidal nevus
  -  Diagnosis of choroidal nevus by direct examination and/or ultrasound/optical coherence tomography and possibly fluorescein angiography OR Primary uveal melanoma
  -  Diagnosis of uveal melanoma by direct examination and/or ultrasound/optical coherence tomography and possibly fluorescein angiography
  Consent 2:
  Mesothelioma
  -  Histologically proven diagnosis of Mesothelioma AND
  -  BAP1 mutation or loss of expression identified in tumor sample
  OR one of the following:
  -  Age<50 at diagnosis
  -  No history of asbestos exposure
  -  Personal history of choroidal nevus, uveal melanoma, melanoma, renal cell carcinoma, or cholangiocarcinoma
  -  Family history of choroidal nevus, uveal melanoma, mesothelioma, renal cell carcinoma, or cholangiocarcinoma
  -  History of malignancy in more than two first-degree relatives OR Choroidal nevus
  -  Diagnosis of choroidal nevus by direct examination and/or ultrasound/optical coherence tomography and possibly fluorescein angiography AND one of the following:
  -  More than one clinical risk factor, which may include: orange pigment, thickness > 1 < 2.5mm
  -  Personal history of uveal melanoma, skin melanoma, mesothelioma renal cell carcinoma, or cholangiocarcinoma
  -  Family history of choroidal nevus, uveal melanoma, mesothelioma renal cell carcinoma, or cholangiocarcinoma OR Primary uveal melanoma
  -  Diagnosis of uveal melanoma by direct examination and/or ultrasound/optical coherence tomography and possibly fluorescein angiography
  AND one of the following:
  -  Personal history of uveal melanoma, skin melanoma, mesothelioma, renal cell carcinoma, or cholangiocarcinoma
  -  Family history of choroidal nevus, uveal melanoma, mesothelioma, renal cell carcinoma, or cholangiocarcinoma
  -  History of malignancy in more than two first-degree relatives OR Metastatic uveal melanoma
  -  Histologically proven diagnosis of metastatic uveal melanoma AND
  -  BAP1 mutation or loss of expression identified in tumor sample
  OR one of the following:
  -  Personal history of uveal melanoma, skin melanoma, mesothelioma renal cell carcinoma, or cholangiocarcinoma
  -  Family history of choroidal nevus, uveal melanoma, mesothelioma renal cell carcinoma, or cholangiocarcinoma
  -  History of malignancy in more than two first-degree relatives
  Consent 3:
  -  Relative of patient with germline BAP1 mutation identified through identified testing
  Exclusion Criteria:

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

Clinical trial: Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

Summary: The purpose of this study is to demonstrate that preoperative biliary drainage using self-expanding metal stents (SEMS) does not negatively impact overall surgical outcomes in patients undergoing pancreaticoduodenectomy for treatment of pancreatic or periampullary cancer.


Eligibility: Inclusion Criteria:
  -  Age 18 or older
  -  Willing and able to comply with the study procedures and provide written informed consent to participate in the study
  -  Diagnosis of probable pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma and other periampullary cancers (histology not required)
  -  Biliary obstructive symptoms or signs
  -  Bilirubin level at/above 100 umol per liter (5.8 mg/dL)
  -  Distal biliary obstruction consistent with pancreatic cancer, distal CBD cholangiocarcinoma or other periampullary malignancy
  -  Location of distal biliary obstruction is such that it would allow the proximal end of a stent to be positioned at least 2cm from the hilum
  -  Patients deemed as resectable by pancreatic protocol CT or MRI
  -  Surgical candidate per pancreatobiliary surgeon after multi-disciplinary discussion
  -  Surgery intent within 4 weeks
  -  Endoscopic and surgical treatment to be provided by same team
  Exclusion Criteria:
  -  Biliary strictures caused by confirmed benign tumors
  -  Biliary strictures caused by malignancies other than pancreatic cancer, distal CBD cholangiocarcinoma and other periampullary cancers
  -  Surgically altered biliary tract anatomy, not including prior cholecystectomy
  -  Neoadjuvant chemotherapy for current malignancy
  -  Palliative indication due to reasons other than surgical candidate status
  -  Previous biliary drainage by ERCP/PTC
  -  Patients for whom endoscopic techniques are contraindicated
  -  Participation in another investigational trial within 90 days
  -  Pregnancy

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

Clinical trial: Selective Internal Radiotherapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Cholangiocellular Carcinoma (CCC).

Summary: Selective Internal Radiotherapy is superior to Transarterial Chemoembolisation for the treatment of intrahepatic cholangiocellular carcinoma (CCC).


Eligibility: Inclusion Criteria:
  -  ≥18 years
  -  Intrahepatic CCC, proven by histology or by typical morphology in cross sectional imaging and elevated tumor markers (CEA or CA 19-9)
  -  Tumor confined to the liver
  -  At least one measurable lesion in magnetic resonance imaging (MRI)
  -  Tumor load ≤ 50%
  -  Preserved liver function (Child Pugh A and B)
  -  ECOG performance status ≤2
  Exclusion Criteria:
  -  Patients feasible for curative treatment (e.g. resection or local ablation)
  -  Previous TACE or SIRT
  -  Prior Chemotherapy
  -  Child Pugh stage C
  -  ECOG Performance Status >1
  -  Tumor involvement >50% of the liver
  -  Extrahepatic tumor
  -  Serum Bilirubin >2.0 mg/dl; Serum Albumin 2.8 g/dl, Serum Creatinine >2 mg/dl; Leukocytes <3000/ml; Thrombocytes <50000/ml
  -  Clinically apparent ascites (ascites only in CT/MRI is no exclusion criteria)
  -  Esophageal bleeding during the last 3 months
  -  Hepatic encephalopathy
  -  Transjugular intrahepatic portosystemic shunt (TIPS)
  -  Infiltration or occlusion of the main portal vein
  -  Hepatofugal blood flow in the portal vein
  -  Hepatopulmonary shunt ≥ 20% in the macroaggregated albumin scan (MAA-scan)
  -  Contraindications against angiography
  -  Pregnancy

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

Clinical trial: Safety and Efficiency of Photodynamic Therapy for Blie Duct Carcinoma

Summary: This research is a prospective randomized controlled trial.It aimed to determine longterm outcomes and factors associated with increased survival after photodynamic therapy (PDT) through T-tube compared with biliary drainage alone in patients presenting with unresectable bile duct cancer.


Eligibility: Inclusion Criteria:
  -  1.Patients with bile duct cancer 2.Patients are willing to join in this clinical trial.
  Exclusion Criteria:
  -  1.Patients with bile duct carcinoma can not suffer PDT procedure. 2.Allergy to photosensitizer

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

Clinical trial: Role of Bile Duct Resection in Major Hepatectomy Due to Intrahepatic Cholangiocarcinoma

Summary: To investigate the prognosis due to presence or absence of bile duct resection in intrahepatic cholangiocarcinoma that require hepatic lobectomy.

Detailed description: The bile duct resection in hepatic lobectomy due to cholangiocarcinoma, mass forming type, is still controversial. We retrospectively evaluated the effect of bile duct resection in this surgery.

Eligibility: Inclusion Criteria:
  -  Cases of major hepatectomy due to intrahepatic cholangiocarcinoma
  Exclusion Criteria:

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

Clinical trial: Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises

Summary: The purpose of this study is to determine whether the investigational drug SelG1 when given to sickle cell disease patients either taking or not taking hydroxyurea is effective in preventing or reducing the occurrence of pain crises. SelG1 prevents various cells in the bloodstream from sticking together. By stopping these cell-cell interactions, SelG1 may prevent small blood vessels from becoming blocked and therefore reduce the occurrence and severity of pain crises. Other effects of SelG1 will also be evaluated, as well as the safety of the drug and how long it stays in the blood stream.
  Funding Source - FDA Office of Orphan Products Development (OOPD)


Eligibility: Key Inclusion Criteria:
  -  Sickle Cell Disease (HbSS, HbSC, HbSβ⁰-thalassemia, or HbSβ⁺-thalassemia)
  -  If receiving hydroxyurea or erythropoietin, treatment must have been prescribed for at least 6 months, with the dose stable for at least 3 months
  -  Between 2 and 10 sickle cell-related pain crises in the past 12 months
  Key Exclusion Criteria:
  -  On a chronic transfusion program or planning on exchange transfusion during the study
  -  Hemoglobin <4.0 g/dL
  -  Planned initiation, termination, or dose alteration of hydroxyurea during the study
  -  Receiving chronic anticoagulation therapy (e.g. warfarin, heparin) other than aspirin

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

Clinical trial: A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients

Summary: The purpose of this study is to compare progression-free survival (PFS)in patients with advanced/metastatic breast cancer who have a BRCA gene change when treated with niraparib as compared to those treated with physician's choice

Detailed description: This is a phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician's choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer patients. Niraparib is an orally active parp inhibitor. Niraparib (in a 2:1 ratio) will be administered once daily continuously during a 21-day cycle. Physician's choice will be administered on a 21-day cycle. Health-related quality of life will be measured. The Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.

Eligibility: Inclusion Criteria:
  1. Germline BRCA1 or BRCA2 mutation; patients with unknown BRCA status who meet NCCN BRCA screening criteria will be screened for BRCA mutation.
  2. Metastatic or locally advanced disease that is not amenable to resection or radiation with curative intent.
  3. Up to 2 prior cytotoxic regimens for advanced or metastatic breast cancer patients with no prior cytotoxic regimens for advanced or metastatic disease will only be allowed if they relapsed during or within 12 months of (neo-) adjuvant cytotoxic therapy that included a taxane and/or anthracycline, if not contraindicated.
  4. Prior therapy should have included a taxane and/or anthracycline (unless contraindication to those) in the neoadjuvant, adjuvant, or advanced/metastatic setting.
  a. Hormone receptor positive patients must also have hormone resistant disease (progression during at least one prior hormonal therapy) for which chemotherapy is indicated.
  5. ECOG performance status 0-2
  6. Adequate bone marrow, kidney and liver function
  Exclusion Criteria:
  1. Patients with platinum resistant cancer
  2. Symptomatic uncontrolled brain metastases
  3. Prior diagnosis of Stage IV ovarian cancer; Stage III ovarian cancer must have a 5-year disease-free interval; Stage II ovarian cancer must have a 2-year disease-free interval
  4. Known hypersensitivity to the components of niraparib
  5. Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)
  6. Pregnant or breast feeding patients
  7. Immunocompromised patients
  8. Known active Hepatitis B or C
  9. Prior treatment with a PARP inhibitor
  10. Known history of myelodysplastic syndrome (MDS).
  11. known and persistent (>4 weeks) >/= grade 3 toxicity or fatigue from prior cancer treatment.

Relevance to patient case: not relevant