araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers

Summary: This study is for people with advanced cancer of the digestive tract and cancer that cannot be completely removed by surgery. Radiation therapy is commonly used in the treatment of these types of cancer in combination with a chemotherapy drug, called 5-fluorouracil (5-FU). In this study, doctors will administer the standard dose of radiation therapy in combination with an investigational chemotherapy drug, called irinotecan. Irinotecan can decrease the size of tumors and also appears to increase the effectiveness of radiation. The purpose of this study is to determine the highest dose of irinotecan that can be given safely in combination with radiation therapy, and to determine the side effects when these two treatments are given together. Irinotecan is approved by the Food and Drug Administration (FDA) for the treatment of colon cancer, but is not approved for cancers of the digestive tract. However, the FDA is allowing its use in this research study.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed neoplasm of the upper gastrointestinal tract (pancreas, stomach, duodenum, common bile duct, ampulla of Vater) or metastatic tumor to the upper abdomen.
  -  Eligible patients include patients with locally advanced unresectable tumors, positive surgical margins, local recurrence and resected stage II-III pancreatic, gastric, duodenum, bile duct or ampulla of Vater carcinoma.
  -  Performance status SWOG 0-2
  -  Fully recovered from prior surgery or chemotherapy (greater than or equal to 4 weeks). Patients previously treated with 5-FU or gemcitabine may start therapy 2 weeks after the last dose of 5-FU or gemcitabine.
  -  Absolute granulocyte count (AGC) > 1500; platelets > 100,000; serum creatinine < 2.0 mg/dl; total bilirubin < 2.0 mg/dl; AST or ALT and alkaline phosphatase < 3 times the upper limit of normal.
  -  Prior chemotherapy is allowed.
  Exclusion Criteria:
  -  Prior radiation therapy to the upper abdomen
  -  Tumors of the gastroesophageal junction.
  -  Other medical, psychological or social circumstances that, in the opinion of the investigator, would prevent participation in the clinical trial
  -  Pregnancy.

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Testosterone Replacement in Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial

Summary: Growing evidence supports the notion that Late-onset Dysthymic disorder in middle aged men may be associated with age-related HPG hypofunctioning. In this study we seek to examine the efficacy of Testosterone replacement for this condition.
  Hypothesis:
  Testosterone replacement will be more effective than placebo, in treating men with late onset Dysthymic Disorder and hypo-gonadism.


Eligibility: Inclusion Criteria:
  1. Male, age 40-80 years.
  2. Diagnosed with hypogonadism (total T level below 350 ng/dl), but not previously treated.
  3. Diagnosis of Dysthymic disorder with onset after age 40.
  4. PSA < 4.0.
  5. Normal digital exam of the prostate in the preceding 1 year.
  6. For subjects currently taking an antidepressant: Current antidepressant treatment last 6 weeks or longer, with decent dose and with no remission (or with partial remission only HAM-D > 12).
  7. Able to give informed consent.
  Exclusion Criteria:
  1. Acute, severe, or unstable prostatitis, symptomatic prostatic hypertrophy, polycythemia, severe acne, breast cancer, prostate cancer, or hypopituitarism.
  2. Currently being treated with testosterone.
  3. Meets lifetime criteria for schizophrenia, schizoaffective disorder, any bipolar disorder (i.e., BP-I, BP-II, or BP NOS); or a major depressive episode in the preceding 5 years.
  4. Current suicidal risk.
  5. Current (past year) substance abuse or dependence.

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Quality Of Life in Patients With Malignant Biliary Obstruction

Summary: You may have symptoms like itching, abdominal pain, loss of appetite, fatigue, fevers and chills. The treatment you will receive to relieve the blockage is also intended to relieve symptoms and improve your quality of life. The purpose of this study is to find out if relieving the blockage in your bile duct improves your quality of life.

Detailed description: Malignant biliary obstruction (MBO) may arise in patients with cholangiocarcinoma, pancreatic carcinoma, primary gallbladder carcinoma, hepatocellular carcinoma, or metastatic disease to the liver or portal lymph nodes. MBO is often accompanied by significant symptoms that may result in impairment of health-related quality of life (HRQL), including pruritus, fever, nutritional deficits, abdominal pain, nausea and vomiting, and fatigue. Approaches to the relief of MBO include surgical bypass and/or resection, percutaneous drainage with or without biliary stenting, or endoscopic stenting. The non surgical procedures may be done prior to attempted curative resection or for palliation in individuals with unresectable or recurrent disease.

Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of malignant biliary obstruction
  -  Radiologic or histologic evidence of MBO
  -  Percutaneous biliary drainage procedure planned or
  -  Surgical biliary enteric bypass, or hepatic resection with biliary reconstruction (high bile duct tumors) planned
  -  KPS >50%
  -  Age 18 years or greater
  -  Able to speak and read English
  -  Able to comprehend and execute informed consent
  -  Prior intervention for MBO not exclusionary
  Exclusion Criteria:
  -  Unable to complete questionnaire due to performance status
  -  Proxy completion is not accepted
  -  Medical or psychiatric condition that, in the judgment of the investigator, prevents appropriate comprehension and execution of either the informed consent or the study instrument

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Coregistration of 18F-FDG-PET and MRI in the Staging of Potentially Resectable Hilar Cholangiocarcinoma: a Pilot Study

Summary: To evaluate the feasibility and performance of coregistered 18F-FDG-PET/MRI in the staging of potentially respectable hilar cholangiocarcinoma.


Eligibility: Inclusion Criteria:
  -  Hilar cholangiocarcinoma assessed by conventional imaging modalities (triphasic CT scan of the liver) and thought to be potentially resectable.
  Exclusion Criteria:
  -  Biliary drain inserted.
  -  Contraindication for MRI.
  -  Pregnant or breast-feeding.
  -  Uncontrolled diabetes (over 9.7 mmol/L).

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures

Summary: The aim of the present study was to compare the effect of unilateral versus bilateral stenting in patients with malignant hilar obstruction.

Detailed description: Cholangiocarcinoma accounts for 3% of all gastrointestinal cancers and is the second commonest primary liver cancer. However only a few patients are suitable for surgical resection and therefore endoscopic biliary drainage is the most used palliative treatment modality for malignant hilar stricture. However, whether one or two stents can benefit the patients most is still to be defined. Numerous retrospective case series reached different conclusion, till now, only one randomized trial compared the effect of unilateral versus bilateral stenting in patients with malignant hilar obstruction, nonetheless, nearly one third of the patients had Bismuth Type I stricture, and one stent is enough for drainage in this situation, therefore, the best drainage strategy for patients with Bismuth Type II or Bismuth Type III malignant hilar obstruction is unknown. The aim of the present study was to compare the effect of unilateral versus bilateral stenting in patients with Bismuth Type II or III malignant hilar obstruction.

Eligibility: Inclusion Criteria:
  -  Consecutive untreated patients with biliary obstruction (Bismuth type II, III) at the hilum due to primary cholangiocarcinoma, gallbladder cancer, or periportal lymph node metastases. Diagnosis is based on US, CT, and MRCP.
  -  Histologic or cytologic confirmation of malignancy is established by percutaneous biopsy (US- or CT-guided) or by endoscopic tissue sampling, endoscopic brushing. Or the diagnosis is based on typical features on imaging and the expected clinical outcome during follow-up.
  -  All patients were considered unsuitable for resection on the basis of general medical condition and/or tumor extent.
  -  Full and informed consent is obtained.
  Exclusion Criteria:
  -  Refuse to participate in this study.
  -  Refuse to provide informed consent.
  -  Refuse to be placed with plastic stents.
  -  Physically unfit for endoscopic treatment.

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Anxiety and Depression Levels in Cancer Patients After Self-Application of EFT (Emotional Freedom Techniques)

Summary: Anxiety and depression have been found to be significant co-occurring conditions in cancer patients. This study examines these and other psychological conditions in patients diagnosed with cholangiocarcinoma, a rare cancer of the bile duct, with an average survival time of three to six months post-diagnosis. Participants are taught EFT in telephone and internet group coaching sessions, and have access to an online support forum. They complete the Mini-Mental Adjustment to Cancer Scale (Mini-MAC), EORTC Quality of Life scale, the PTSD checklist, the Patient Health Questionnaire, and a brief health checklist. Participants also provide medical records confirming their diagnosis, and markers, both before and after the study. The study is expected to enroll 20-15 cholangiocarcinoma patients, and use a within-subjects, time series, repeated measures design. Symptoms are assessed prior to coaching, after four, and again after eight weekly coaching sessions. Follow-ups will occur in one month, three months, and one year. It is hypothesized that a drop in the severity of co-occurring psychological symptoms, pain and insomnia may occur after EFT coaching.


Eligibility: Inclusion Criteria:
  -  Diagnosis of cholangiocarcinoma
  -  Ability to complete forms and attend phone coaching sessions
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Preoperative Biliary Drainage for Resectable Hilar Cholangiocarcinoma

Summary: This study is to investigate whether preoperative biliary drainage can reduce the postoperative morbidity in patients with hilar cholangiocarcinoma.

Detailed description: Preoperative biliary drainage(PBD) or not, is a Hot Spot issue in the management of Hilar cholangiocarcinoma. Surgeons from Japan tend to perform PTBD(Percutaneous Transhepatic Biliary Drainage) before a definite operation until the total bilirubin(TB) lower than 85μmol/L. For some patients needed to perform extended curative resection, PVE(Portal Vein Embolization) is performed and thus the duration of PBD may be around six weeks and the final TB is lower than 34μmol/L. Some tend to perform a definite curative operation in a short time after diagnosis. There is no RCT research on the effect of PBD for the resectable Hilar Cholangiocarcinoma patients to date.

Eligibility: Inclusion Criteria:
  -  Patients newly diagnosed
  -  Resectable patients after imaging assessment and evaluation of general condition of the patient
  -  TB>85μmol/L
  -  WBC account more than 1.5×109/L, PLT account more than 100×109/L and HB account more than 100g/L
  -  No serious disease in heart, lung and kidney
  -  Written informed consent
  Exclusion Criteria:
  -  Unresectable patients.
  -  Patients have received biliary drainage procedure such as PTBD before admission
  -  Complicated with chronic hepatitis
  -  Myocardia infarction record within six months
  -  Women in pregnancy
  -  Serious disease in heart, lung or kidney

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Magnetic Resonance (MR) Imaging to Determine High Risk Areas in Patients With Malignant Gliomas and to Design Potential Radiation Plans and to Examine Metabolite Changes in Gliomas and Other Solid Tumors

Summary: The purpose of this study is to assess the ability of these advanced MRI scans in predicting areas within a malignant glioma (brain tumor) that are at a high risk of recurring. If these advanced MRI scans are able to identify the cancerous part of the tumor, then radiation therapy can be targeted to those sites and possibly improve patient survival.


Eligibility: Inclusion Criteria:
  -  Suspected or Histopathologically proven diagnosis of high grade or low glioma or tumor is suspected to harbor an isocitrate dehydrogenase (IDH) mutation
  -  May undergo radiation therapy
  -  Patient and/or guardian is able to provide written informed consent prior to study registration
  -  Age ≥ 18 years old
  Exclusion Criteria:
  -  Extreme claustrophobia that precludes MRI scan
  -  Known allergic reaction to Gd-DTPA
  -  Any contraindication to gadolinium intravenous contrast as per standard Department of Radiology contrast guidelines
  -  Any absolute contraindication to MRI (e.g., pacemaker, aneurysm clip, tissue expander).
  -  Pregnant or nursing female
  -  Unable to cooperate for MRI and/or radiation therapy planning

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: A Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures

Summary: The purpose of the study is to determine the best management of bile duct narrowing (stricture) due to inoperable tumors. The bile duct is a tube that carries bile formed in the liver to the small bowel to digest fats. Tumors around the bile duct can compress the duct causing pain, jaundice (yellow skin and eyes), itchy skin and fever.

Detailed description: This is a prospective randomized trial conducted at 4 large teaching hospitals (Brigham and Women's Hospital, Massachusetts General Hospital, and Boston Medical Center, Boston, Massachusetts, and Mayo Clinic, Rochester, Minnesota). Inclusion criteria are (1) age ≥18 years; (2) malignant distal (≥1 cm distal to the biliary hilum) biliary obstruction amenable to stent placement; and (3) not a candidate for curative surgical resection due to tumor stage, operative risk, or patient wishes. Exclusion criteria are (1) inability to obtain informed consent, (2) contraindication to ERCP, (3) prior biliary SEMS placement, and (4) prior biliary surgery. Malignancy is determined by pathology. Cancer stage is determined by transabdominal imaging and/or EUS. Written informed consent is obtained from each of the enrolled patients. The study is approved by the Institutional Review Boards at each of the participating centers.

Eligibility: Inclusion Criteria:
  -  greater than 18 years of age.
  -  Malignant bile duct stricture.
  -  Increased bilirubin.
  -  Duct stricture is > 1 cm distal to the biliary hilum (bifurcation of the common hepatic duct into the right and left hepatic ducts).
  -  Not an operative candidate.
  Exclusion Criteria:
  -  Unable to obtain consent.
  -  Unable to tolerate procedure.
  -  Suspected benign bile duct stricture.
  -  Candidate for potentially curative surgical intervention.
  -  Previous metallic biliary stent.
  -  Previous bile duct surgery.

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Covered or Uncovered Bile Duct Stents

Summary: The study is investigator initiated. Tumors that gives the narrowing of the bile ducts prevents bile from flowing from the liver to the intestine resulting in jaundice and the risk of bacterial growth in bile with severe infections as a result. Unresectable bile duct strictures have routinely been treated them with plastic stents. The plastic stents have been replaced by self expandable metallic stents.
  These stents remain open longer for reasons that they have a larger diameter so that the bile flows through more easily. One problem with these stents, however, is that the tumor growing through the wire mesh which forms the wall of the stent. This has led to the development of so-called covered stents. Whether covered stents have longer patency is unclear as well as whether they are as safe. There is reason to believe that covered stents remain open longer, but there may be an increased risk of migration and other complications.
  The purpose is to prospectively and randomized compare the two stent types. The study endpoint is the clogging of the stent or the patient's death. We also monitor complications, regress time of the jaundice and success rate of stent placement

Detailed description: 0

Eligibility: Inclusion Criteria:
  -  Patients with unresectable, distal bile duct stricture needing relieved endoscopically
  -  Expected survival greater than 3 months
  -  The patient must give written consent to participate in the study
  Exclusion Criteria:
  -  Stricture close to hilus
  -  Need for interpreter

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Biomarkers in Bone Marrow Samples From Patients With Acute Myeloid Leukemia

Summary: RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is studying bone marrow samples from patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:
  -  To rigorously examine fractionated hematopoietic stem and progenitor cells from patients with acute myeloid leukemia (AML).
  -  To define somatic mutations occurring in de novo AML, including the FLT3-ITD, CEBPA, NPM1, TET2, ASXL1, IDH1, and IDH2 mutations.
  -  To examine what cellular compartments (LT-HSC, ST-HSC, CMP, GMP, and MEP) contain the selected mutations and in what order those mutations occur.
  OUTLINE: Archived bone marrow specimens are analyzed for sequencing and detection of mutations by Sanger-based resequencing of PCR amplicons. Results are then compared with the results of age-matched healthy controls.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of acute myeloid leukemia
  -  Bone marrow samples must meet 1 of the following criteria:
  -  Normal karyotype from patients enrolled on ECOG-1900 archived at the ECOG Leukemia Tissue Bank
  -  Live, sortable mononuclear cells prepared at the time of initial diagnosis (slow-frozen in media with 10% DMSO OR fresh cells shipped immediately
  -  Age-matched healthy control samples from commercial providers
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer

Summary: The purpose of this study is to assess safety and ability of the endoscopic bipolar radiofrequency ablation (RFA) probe (ENDOHPB) to produce an improvement in the management of cancer of the bile duct or the pancreatic duct. By using radiofrequency (RF) energy to heat the tissue in the duct prior to insertion of the stent, the surrounding tissue becomes coagulated and this may delay tumour growth and the time before the stent lumen becomes blocked. Thereby, allowing increased periods between the need for intervention and further stent deployment. The study will look to see if the ENDOHPB is able to keep the stent open longer and perhaps decrease the number of invasive procedures for occluded (blocked) stents.

Detailed description: Only a small proportion of patients with biliary obstruction caused by cholangiocarcinoma or pancreatic cancer are suitable for surgical resection. As the cancer grows, it blocks the drainage of the bile ducts that carry digestive juices from the gall bladder and pancreas to the small intestine. Blocked drainage causes abdominal pain, bloating, and nausea. ERCP (endoscopic retrograde cholangiopancreatography) is often prescribed. ERCP with stent placement is the standard medical procedure for people with bile duct and pancreatic cancer.
  The purpose of this study is to assess safety and ability of the endoscopic bipolar radiofrequency ablation (RFA) probe (ENDOHPB) to produce an improvement in the management of cancer of the bile duct or the pancreatic duct. By using radiofrequency (RF) energy to heat the tissue in the duct prior to insertion of the stent, the surrounding tissue becomes coagulated and this may delay tumour growth and the time before the stent lumen becomes blocked. Thereby, allowing increased periods between the need for intervention and further stent deployment. The study will look to see if the ENDOHPB is able to keep the stent open longer and perhaps decrease the number of invasive procedures for occluded (blocked) stents.
  The objectives are:
  • To assess assess the safety and effectiveness of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer

Eligibility: Inclusion Criteria:
  -  Either gender greater than or equal to 18 years of age.
  -  Pancreatic cancer or cholangiocarcinoma unsuitable for surgical resection. Criteria of unresectability being based on 1) metastatic disease or 2) locally advanced.
  -  Biliary obstruction
  -  Blocked self expanding mesh metal stent (SEMS)
  -  Subjects capable of giving informed consent
  -  Life expectancy of at least 3 months
  Exclusion Criteria:
  -  Cardiac Pacemaker
  -  Patient unstable for endoscopy
  -  Inability to give informed consent
  -  Uncorrected coagulopathy

Relevance to patient case: not relevant