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

Clinical trial: Proton Radiation Therapy for Gliomas

Summary: In this research study the investigators are looking at a type of radiation called proton radiation. Proton radiation has been shown to deliver virtually no radiation beyond the area of the tumor, sparing surrounding normal tissue from exposure. This may reduce side effects that patients would normally experience with conventional radiation therapy.
  In this research study the investigators are looking to determine if proton radiation with a reduced field size will be as effective in controlling tumor growth as photon therapy, while reducing the treatment-related side effects observed in patients with brain tumors.

Detailed description: Proton radiation will be delivered daily for approximately 6 weeks. Subjects will be assessed weekly for side effects. Each visit will take about 15 minutes.
  Subjects will have follow-up visits at 3, 6, 12, 24, 36, 48, 60, 72, and 84 months after their last proton radiation treatment. They will receive a physical exam, MRI, have blood tests (about 4 teaspoons) and answer questionnaires regarding medical history, quality of life, and emotional well-being. Subjects will also receive a neurocognitive exam annually.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed low-grade gliomas OR Grade III anaplastic glioma with either or both IDH1 mutation or 1p/19q codeletion
  -  Subject must be indicated for radiation therapy
  -  Life expectancy greater than 5 years
  -  Willing to participate in rigorous neurocognitive evaluations at baseline and serially following treatment
  -  Able to speak and comprehend English
  -  Recovered from adverse events due to agents administered more than 4 weeks before entering study
  -  Able to undergo MRI scans
  Exclusion Criteria:
  -  Prior cranial radiation therapy
  -  Chemotherapy within 4 weeks prior to entering study
  -  Pregnant or breastfeeding
  -  Known brain metastases
  -  Baseline neurocognitive or emotional disorders
  -  Uncontrolled intercurrent illness
  -  History of a different malignancy unless disease-free for at least 5 years
  -  HIV positive on antiretroviral therapy

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

Clinical trial: Clinical Trial for Evaluation of Ethnic Differences in Pharmacokinetics of Chloroquine, an Anti-malarial Drug

Summary: Chloroquine is an anti-malaria agent. This study is designed to evaluate inter-ethnic differences of therapeutic effect of chloroquine and search the cause of these ethnic differences. For this purpose, chloroquine will be administered to four ethic groups of Korean, Caucasian, African and Southeast Asian and chloroquine concentration in blood will be measured. The result of this study will be helpful in finding more adequate dosing regimen of chloroquine in patients with malaria.


Eligibility: Inclusion Criteria:
  -  aged 20 - 50 male subjects (6 Koreans, 6 Caucasians, 6 Africans and 6 Southeast Asians)
  -  Subjects with body weight ≥ 45 kg and within ±20% of the ideal body weight : Ideal body weight = (height [cm] - 100)x0.9.
  Exclusion Criteria:
  -  Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
  -  Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.

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

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

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify and lean more about biomarkers related to cancer.
  PURPOSE: This research study is studying biomarkers in blood samples from patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:
  Primary
  -  To determine if serum 2-hydroxyglutarate (2HG) is only detected in acute myeloid leukemia (AML) patients with isocitrate dehydrogenase (IDH) mutations.
  Secondary
  -  To determine if the level of serum 2HG impacts leukemia-free survival (LFS).
  -  To determine if the level of serum 2HG impacts overall survival (OS).
  -  To determine if serum 2HG is undetectable at the time of documented clinical remission (CR) in IDH-mutated patients.
  OUTLINE: Archived serum samples are analyzed for 2-hydroxyglutarate expression by reverse-phase liquid chromatography coupled to mass spectrometry. Results are then compared with presence or absence of an IDH mutation, patients' clinical outcome, as well as age, sex, white blood cell count at diagnosis, platelet count, bone marrow blast percentage at diagnosis, circulating (serum) percentage at diagnosis, cytogenetic risk group, presence of FLT3, NPMN1, and/or TET2 mutations, specific IDH mutation, and randomization treatment group allocation.

Eligibility: DISEASE CHARACTERISTICS:
  -  Morphologically confirmed acute myeloid leukemia (AML)
  -  Newly diagnosed with AML
  -  Serum samples from patients enrolled on the ECOG-1900 clinical trial between 2002 and 2008
  -  Patients with or without isocitrate dehydrogenase (IDH) mutations
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Received 2 different doses of standard induction chemotherapy on ECOG-1900

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

Clinical trial: Prospective Study Comparing EUS vs ERCP Stent Insertion for Malignant Biliary Obstruction

Summary: 1. Purpose of the study
  -To compare stent patency and complication rate between endoscopic ultrasound (EUS) guided stent insertion and endoscopic retrograde cholangiopancreatography (ERCP) guided stent insertion for malignant biliary obstruction
  2. Subjects of the study
  -Patients who have biliary obstruction owing to malignant tumors
  3. Methods of the study
  -  Prospective randomized controlled study
  -  Patients were enrolled randomly in two groups, EUS guided stent insertion group or ERCP guided stent insertion group
  -  Patients will get assigned procedure (EUS guided stent insertion or ERCP guided stent insertion)for decompression of malignant biliary obstruction
  -  After the procedure, regular follow up, blood test,and imaging test will be done to check sufficient biliary decompression,stent patency and complications.

Detailed description: 1. Inclusion criteria 1) age: 18 - 80 2) a patients who had common bile duct dilatation because of malignant distal common bile duct obstruction in radiologically 3) Hyperbilirubinemia (total bilirubin >= 1.5 mg/dl) 4) inoperable state 5) a patients who agree to join this study
  2. Exclusion criteria 1) a patients who can not endure sedation 2) a patients with bleeding tendency (PT > 1.5 INR, PLT < 50,000) 3) a patients with systemic infection 4) a patients who had hilar obstruction

Eligibility: Inclusion Criteria:
  -  distal biliary obstruction due to malignant tumor
  -  unresectable tumor
  -  Jaundice
  Exclusion Criteria:
  -  Children
  -  Hilar obstruction
  -  Active infection
  -  Bleeding tendency

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

Clinical trial: Comparison of Biliary Stenting Alone vs. Stenting With Photodynamic Therapy (PDT) During ERCP

Summary: This study entails retrospective and prospective review of data from a database protocol. Data gathered will be then analyzed for a set amount of patients. In this study, the investigators will compare biliary stenting vs. biliary stenting plus photodynamic therapy (PDT) and assess if PDT can improve quality of life and prolong survival.

Detailed description: Successful palliation of biliary obstruction is the main goal for reducing morbidity and mortality in patients with biliary disease and biliary obstruction related to cholangiocarcinoma. Surgical biliary bypass is unfortunately complicated by a 30-day postoperative mortality rate of between 7 and 24%. Moreover, because of recovery time the quality of life following surgery is only improved in a minority. At present endoscopic insertion of a plastic or metal stent is the method of choice to relieve obstructive jaundice without the high morbidity and mortality associated with surgery. But this relief is unfortunately temporary since stents tend to become obstructed and the fact that effective biliary drainage in the proximal lesion is challenging. Photodynamic Therapy (PDT) is a new therapeutic approach that specifically targets neoplastic cells. This therapy involves the intravenous administration of a photosensitizing agent followed by activation of the agent by illumination with non-thermal light of a specific wavelength, resulting in cell death from direct cytotoxicity and ischemic necrosis. Cytotoxicity is directly proportional to tissue oxygenation.
  A prospective, randomized and controlled trial study by Ortner et all confirmed the significant advantage of PDT with regard to relief of jaundice, quality of life, and survival. The improvement of survival in the randomized PDT group was so impressive that it was believed unethical to continue with randomization after the first 39 patients (20 and 19 in each group).Previously, the principal investigator conducted such a study (and also conducted Endoscopic Retrograde Cholangiopancreatography with PDT) at the University of Virginia, and would continue to conduct these procedures, as well as the study at WCMC.

Eligibility: Inclusion Criteria:
  -  Any patient who has undergone ERCP (Endoscopic Retrograde Cholangiopancreatography) and Biliary stenting with or without Photodynamic Therapy.
  -  Biliary disorder or obstruction due to Cholangiocarcinoma.
  -  Above 18 years of age.
  Exclusion Criteria:
  -  Any patient who has not undergone ERCP and biliary stenting.
  -  Not diagnosed with Cholangiocarcinoma.
  -  Below 18 years of age

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

Clinical trial: Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry

Summary: The objective of this protocol is to establish a multicenter registry to evaluate the impact of radiofrequency ablation in the management of patients with pancreatico-biliary disorders including malignancies.

Detailed description: Bile duct cancer and pancreatic cancer are cancers that cannot be surgically removed. 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. ERCP (endoscopic retrograde cholangiopancreatography) is often prescribed during which a tube with a tiny camera attached is inserted through the subject's mouth and advanced to a place in the small intestine where the bile duct empties. Through this scope the doctor enlarges the ducts with tiny balloons and places plastic or metal stents (straws) that help keep the bile ducts open so they can drain properly. However, due to the cancer, the stents are blocked eventually.
  The purpose of this registry is to record information and evaluate the impact of radiofrequency ablation (RFA) of endoscopic radiofrequency ablation (RFA) probes in improving the management of bile duct cancer or pancreatic cancer by ablating the tissue in the bile duct(s) before the stent(s) are implanted. By using radiofrequency (RF) energy to heat the tissue in the duct(s) prior to stent(s) insertion, the surrounding tissue becomes coagulated and this may delay tumor growth and the time before the stent lumen becomes blocked. Thereby, allowing increased periods between the need for intervention and further stent implantation(s). The registry will evaluate the efficacy and safety of RFA procedures conducted for pancreatico-biliary disorders.
  The safety and efficacy of various radio frequency ablation probes have been assessed in a series of studies. This multi-center registry has been initiated:
  1. To document the immediate and post procedure clinical performance of radio frequency ablation in a 'real world' patient population requiring stent implantation for pancreaticobiliary disorders.
  2. To assess the immediate and 6 months post procedure adverse event rate in patients.
  3. To assess the impact of RFA on the life expectancy of patients suffering from pancreaticobiliary malignancies.

Eligibility: Inclusion Criteria:
  -  Patients who have undergone RFA for pancreaticobiliary disorders
  -  Above 18 years of age
  Exclusion Criteria:
  -  Patients who have not undergone RFA
  -  Below 18 years of age

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

Clinical trial: Stenting Malignant Jaundice for Quality of Life

Summary: Endoscopic stent insertion is considered the method of choice for palliation of malignant bile duct obstruction (MBDO). However, it can cause complications and requires periodic stent exchanges. While endoscopic stenting is clearly indicated for relief of cholangitis or refractory pruritus, its role in patients with jaundice alone is less clear. Endoscopic stenting for this relative indication might be justified, if there is a significant improvement in quality of life (QOL) of such patients. The aim of the investigators study was to determine whether endoscopic stenting for MBDO results in improved QOL.

Detailed description: Most malignant tumors causing bile duct obstruction, such as pancreatic adenocarcinoma, gallbladder carcinoma or cholangiocarcinoma, have an extremely poor prognosis. At the time of diagnosis the majority of these tumors will be unresectable with a median survival of 4-6 months. Palliation is the goal for those patients with unresectable tumors and limited survival and for those at high risk for attempts at curative resection.
  Endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic stent insertion is considered the method of choice for palliative treatment of malignant bile duct obstruction (MBDO). However, it can cause complications, such as pancreatitis, bleeding, perforation, cholangitis and stent migration in a significant proportion of treated patients. Clogging of plastic stents is a predictable consequence and requires periodic stent exchanges with attendant risks and costs. While endoscopic stenting is clearly indicated for relief of cholangitis or refractory pruritus, the role of stenting in patients with jaundice alone, abdominal pain, or failure to thrive due to malignancy is less clear. Given the risk for complications and costs, endoscopic therapy might be justified in these clinical scenarios if quality of life (QOL) is significantly improved. A few available studies have demonstrated improved QOL in stented patients. However, these studies include a small number of patients and/or are retrospective in design. Therefore, more evidence to support routine palliative biliary drainage in patients with MBDO is desired.

Eligibility: Inclusion Criteria:
  -  Patients with suspected or proven malignant biliary obstruction who were unresectable or inoperable and were undergoing ERCP and biliary stenting for biliary depression.
  Exclusion Criteria:
  -  Had previously undergone biliary stenting
  -  Surgery was planned
  -  A guidewire could not be passed through the stricture
  -  Suspected survival of < 3 months
  -  Impending duodenal obstruction

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

Clinical trial: Liver Transplantation for Hilar Cholangiocarcinoma in Association With Neoadjuvant Radio- and Chemo-therapy

Summary: Single-arm pilot clinical trial. Patients with non operable CC associated with PSC will be subjected to liver transplantation after a neoadjuvant multimodal therapy protocol.
  Cholangiocarcinoma (CC) accounts for 3% of all gastrointestinal cancers; it is more frequent in patients with primary sclerosing cholangitis (PSC), who carry an 8%-12% risk of developing this type of neoplasm. Only a minority of patients are suitable for resection partly because of the anatomic position of the tumor (which often arises from the bile duct bifurcation) and partly because of the frequently coexisting liver disease. In fact, CC is currently considered a major contraindication to liver transplantation (OLT) at the majority of centers, given a 5-year survival rate of 0%-35%.
  New strategies have been developed for the treatment of this kind of cancer arising in PSC. The Nebraska University group showed a 1 and 3 years survival of 55 and 45 % combining a neoadjuvant intra bile duct barchytherapy and 5-FU based chemotherapy with liver transplantation. University of Pittsburg proposed also a neoadjuvant protocol prior to liver transplantation based on systemic chemotherapy and external radiotherapy reporting a 53% 5 years survival. More convincing results come from the Mayo Clinic. An accurate selection of patients and a proper neoadjuvant multimodal therapy (chemotherapy, external radiotherapy and intraluminal bile duct brachytherapy) lead to a 80% 5 years survival after liver transplantation.


Eligibility: Inclusion Criteria:
  -  Older than 18 years
  -  Male or female
  -  Diagnosis of Cholangiocarcinoma using:
  -  PTBD biopsy or Brushing cytology
  -  Ca 19-9>100mg/ml and/or liver mass at CT or MRI with malignant stenosis apperance at Cholangiography,
  -  Non resectable tumour araising above the cystic duct
  -  Absence of intra and extra hepatic metastasis
  -  ECOG score(Eastern Cooperative Oncology Group) 0
  -  ASA score (American Society of Anesthesiologists) ≤ 3
  -  Ability to understand and willingness to sign the written informed consent form (ICF)
  Exclusion Criteria:
  -  Intrahepatic Cholangiocarcinoma
  -  Non controlled infection
  -  Previous radio or chemotherapy
  -  Previsous bile duct resection or attempt to resection
  -  Intra and/or extrahepatic metastasis
  -  Preivious malignant neoplasm (within 5 years)
  -  Execution of trans peritoneal biopsy
  -  Tumour diameter more than 3 cm

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

Clinical trial: Endoscopic Ultrasound as an Early Diagnostic Tool for Primary Sclerosing Cholangitis

Summary: Primary sclerosing cholangitis (PSC) is a rare chronic cholestatic liver disease, typically affecting middle aged men and is frequently associated with inflammatory bowel disease. Establishing diagnosis in early stages of cholestatic hepatopathy is still a clinical challenge and based on invasive diagnostic procedures: endoscopic retrograde cholangiography (ERC) or percutaneous liver biopsy are needed when magnetic resonance cholangiopancreaticography remains inconclusive. As these procedures are associated with significant risks for the patient, the goal of this study is to evaluate, if endoscopic ultrasound (EUS) of the biliary tract is a useful diagnostic tool in suspected PSC.

Detailed description: Different parameters of the common bile duct (wall thickness and irregularity, irregularity of the common bile duct and enlarged lymph nodes) are measured in patients with cholestatic hepatopathy of unknown causes via endoscopic ultrasound (EUS).
  This EUS of the CBD is performed from the bulbar position in the duodenum and at least 5 cm of bile duct had to be visualized to correctly analyze bile duct structure.
  Further diagnostic work-up of these patients is performed following current guidelines, and definite diagnosis is compared with results of EUS parameters measured. Thus, diagnostic yield of EUS in patients with suspected PSC is further evaluated.

Eligibility: Inclusion Criteria:
  -  cholestatic hepatopathy defined by elevation of gamma-GT and alkalic phosphatase and
  -  elevated pANCA and / or medical history of inflammatory bowel disease
  Exclusion Criteria:
  -  sign of significant intrahepatic cholestasis or any other cause of necessity of cholangiography on transabdominal ultrasound

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

Clinical trial: Bile and Bile Duct/Pancreatic Duct Brushings Database for Patients With Pancreato-biliary Stricture

Summary: The purpose of this study is to create a long-term storage of bile and brushings of pancreato-biliary duct in patients diagnosed with pancreato-biliary stricture for future research.
  Recently, a lot of research has been done to test for certain markers in the bile and brushings to detect cancer in a stricture. The samples will be used to measure biomarkers (proteins) in biliary diseases.

Detailed description: Recently, a lot of research has been done to test for certain markers like fluorescence in situ hybridization (FISH), digital image analysis (DIA), and quantifiable morphometric results in biliary stricture brushings. Recently, polysomy FISH has been studied as a promising marker in predicting cancer in a pancreato-biliary stricture. Many genetic, epigenetic, and protein alterations arise during pancreaticobiliary tumor process. The types of markers that have been commonly evaluated as diagnostic assays are mutations, chromosomal gains and losses, and DNA methylation alterations. However there are only a few studies in this area. Testing for these markers can help determine whether the narrowing or stricture in your bile duct is cancer or not.

Eligibility: Inclusion Criteria:
  -  Any patient diagnosed with pancreato-biliary stricture.
  -  Age >18 years
  -  Ability to provide an informed consent
  Exclusion Criteria:
  -  Patients with altered mental status, who will not be able to provide an informed consent
  -  Pregnant women

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

Clinical trial: The Use of Thermal Suits as Preventing Hypothermia During Surgery

Summary: Unintentional hypothermia of a patient is a common adverse effect during surgical procedures. The aim of this prospective, randomised, controlled study is to determine whether the use of thermal suit could prevent surgical patient from experiencing thermal loss than conventional measures.
  Hypothesis: The investigators assume that a difference of 0.5°C in body temperature between the groups is clinically relevant.

Detailed description: The aim of this study was to compare a thermal suit (T-Balance) and conventional warming methods to maintain a constant body temperature in patients undergoing robotic laparoscopic radical prostatectomy under general anesthesia.
  A sample size calculation was made using a power analysis. Patients were randomly allocated into two groups.
  Patients in the intervention group were put on the T-Balance 1 hour before anesthesia induction. Patients in the control group got conventional cotton clothes. Intra-operatively same warming methods were used in both groups. The measuring points of the temperature were esophagus (core temperature), left axilla, dorsal surface of the left middle finger and back of the left foot.
  Anesthesia was induced via target-controlled infusion. All temperature data of the patients were collected and recorded electrically and continuously.

Eligibility: Inclusion Criteria:
  -  radical prostatectomy, American Society of Anaesthesiologists class I-III, age 18-90
  Exclusion Criteria:
  -  mental status with inability to give informed consent, neuromuscular disorders, Raynaud`s disease, unstable angina pectoris

Relevance to patient case: not relevant