araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

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: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Mechanisms of Intradialytic Hypertension

Summary: Patients with end-stage renal disease (ESRD) are at significantly higher risk for death due to cardiovascular disease. Those with paradoxical increases in blood pressure (BP) during hemodialysis (HD), defined as intradialytic hypertension (IDH), are at even greater risk of cardiovascular mortality. This study seeks to determine the mechanisms that underlie IDH, and whether mindfulness meditation might improve BP during dialysis in these patients. The investigators will first determine if increased adrenaline levels during volume removal contributes to IDH. The investigators will then determine lack of suppression of adrenaline levels in the setting of a high BP also contributes to IDH. This will be done by manipulating blood pressure by using small amounts of vasoactive drugs, and determining if an appropriate response in adrenaline levels occurs. Lastly, the investigators will determine if an intradialytic mindfulness meditation program improves BP and adrenaline levels in ESRD patients with IDH.


Eligibility: Inclusion Criteria:
  -ESRD patients on maintenance hemodialysis for at least 6 months, with increased blood pressure during hemodialysis.
  Exclusion Criteria:
  -  drug or alcohol abuse
  -  any serious systemic disease that might influence survival
  -  severe anemia with hgb level <8 g/dL
  -  clinical evidence of congestive heart failure
  -  ejection fraction below 35%
  -  myocardial infarction or cerebrovascular accident within the past six months
  -  symptomatic heart disease determined by electrocardiogram, stress test, and/or -history
  -  treatment with central alpha agonists or MAO inhibitors
  -  peripheral neuropathy
  -  autonomic dysfunction
  -  pregnancy
  -  surgery within the past 3 months.

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

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: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

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: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

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
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Effects of Drainage in Laparoscopic Cholecystectomy

Summary: During laparoscopic surgery for an acutely inflamed gallbladder, most surgeons routinely insert a drain. However, no consensus has been reached regarding the need for drainage in these cases, and the use of a drain remains controversial. This study is coordinated to find out the surgical outcomes and perioperative morbidity according to the insertion of drain after laparoscopic cholecystectomy. Investigators expect that the routine use of a drain after laparoscopic cholecystectomy for an acutely inflamed gallbladder will have no effects on the postoperative morbidity.

Detailed description: Drain has been widely used in many abdominal surgeries for therapeutic purposes such as the removal of infected debris or abscess, and supporting the healing of leakage or fistula. Although the usability of therapeutic drain is commonly accepted, the efficacy of prophylactic drain still has been debated. Most surgeons have inserted prophylactic drain with expectations that the drain would be helpful for early detection of postoperative bleeding or leakage, and also prevention of intra-abdominal abscess through removing debris or curd. However, there are only few evidence-based studies for the actual effectiveness of prophylactic drain and the objections against the routine use of drain have been raised.
  Most surgeons have placed the drain after cholecystectomy with expectations that it could help to detect postoperative bleeding or bile leakage and prevent intra-abdominal infection. However, there is a lack of evidence regarding the role of drain in laparoscopic cholecystectomy for acutely inflamed gallbladder and surgeons have placed the drain based on their experiences and beliefs, not on evidence-based guidelines. In the previous retrospective study, [4] we described that the routine drain use in laparoscopic cholecystectomy for acutely inflamed gallbladder has no advantage to detect bile leak or bleeding and it was no helpful to prevent the postoperative morbidities such as intra-abdominal abscess or wound infection. The aim of present multicenter trial is to assess the value of routine drain use in laparoscopic cholecystectomy for acutely inflamed gallbladder in a large, randomized controlled prospective study.

Eligibility: Inclusion Criteria:
  -  acutely inflamed gallbladder
  Exclusion Criteria:
  -  chronic cholecystitis
  -  gallbladder polyp or gallbladder cancer
  -  the patient who underwent reduced port surgery
  -  the patient who underwent common bile duct exploration during the operation
  -  the patient who underwent concurrent operation
  -  the patient who had past history of upper abdominal surgery
  -  the patient who had a immunodeficiency state
  -  the case which had a suspicion of delayed bile leakage
  -  the case which had a incomplete cystic duct ligation
  -  the patient who underwent open conversion surgery during the operation
  -  the patient who had a high risk of bleeding

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Post-Marketing Requirement to Evaluate the Safety of Octaplas™ Versus Plasma in Patients Undergoing Orthotopic Liver Transplantation With Special Emphasis on Hyperfibrinolysis.

Summary: Post-Marketing Requirement study to evaluate the safety of octaplas™ versus plasma in patients undergoing orthotopic liver transplantation (OLT). The primary objective is to assess the incidence of hyperfibrinolysis in patients undergoing (OLT) receiving octaplas™ versus regular plasma (e.g., fresh frozen plasma and other FDA and AABB approved plasma products).


Eligibility: Inclusion Criteria:
  -  Male or female age ≥18 years
  -  Patient is scheduled to undego orthotopic liver transplantation (OLT)
  -  Patient has a natural MAYO End-Stage Liver Disease (MELD) score of 15-40
  -  Patient is willing to give voluntary written informed consent before any study- related procedure is to be performed that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudicing future medical care
  Exclusion Criteria:
  -  Patient has a history of severe hypersensitivity reaction to plasma-derived products or to any excipient of the investigational product
  -  Patient is known to be IgA deficient with documented antibodies against IgA
  -  Patient is a planned recipient for a living donor OLT
  -  Patient has a severe deficiency of Protein S
  -  Patient is currently participating in an interventional clinical study or has participated in one within 30 days of the date of their OLT

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Treatment Response and Prognosis in Glioma Patients: Q Cell and Its Biological Characteristics

Summary: The purpose of this study is to determine whether Q cells separated from the glioma sample are determinants in treatment response and prognosis of glioma patients

Detailed description: The unique markers of Qcell were screened using the method of genomics and
  proteomics, then these markers will be qualitatively and quantitatively evaluated in
  glioblastoma patients by comparing their relationship with overrall
  survival/progression-free survival and treatment response.

Eligibility: Inclusion Criteria:
  1. >=18 years old
  2. Primary Glioblastoma is newly diagnosed and confirmed histologically
  3. Patient is expected to be treated with temozolomide and followed up routinely at the study site.
  4. Willing to sign the informed consent
  Exclusion Criteria:
  1. Currently enrolled in any other clinical study
  2. History of any other malignancies
  3. Refusal to give consent
  4. No available tumor tissue for IDH analysis.

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS)

Summary: Photodynamic therapy (PDT) is a combination of a drug, porfimer sodium (Photofrin), which is activated by a light from a laser that emits no heat. This technique works to allow the medical doctor to specifically target and destroy abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation of the drug is done by lighting the abnormal areas using a fiber optic device (very fine fiber like a fishing line that permits light transmission) inserted into a flexible tube with a light called cholangioscope for the bile duct. The light will activate the porfimer sodium concentrated in the abnormal tissue, leading to its destruction.
  This research study will evaluate the efficacy and safety of PDT with porfimer sodium administered with Standard Medical Care (SMC) compared to SMC alone on the overall survival time of patients with non-operable advanced cholangiocarcinoma, a rare cancer of the bile ducts. It will involve 200 patients across North America and Europe. Other countries may participate if needed. Participation will last at least 18 months.


Eligibility: Inclusion Criteria:
  -  Males or females aged 18 or older
  -  Diagnosed with radiologically and biopsy or cytology confirmed inoperable perihilar cholangiocarcinoma Bismuth Tumor Stage III/IV
  -  Non-menopausal or non-sterile female subjects of childbearing potential must have a negative serum beta-HCG and use a medically acceptable form of birth control
  -  Able to sign an informed consent
  Exclusion Criteria:
  -  Diagnostic of cholangiocarcinoma made more than 45 days prior to randomization
  -  Cholangiocarcinoma with extra-hepatic metastasis or concurrent non-solid malignancy
  -  Presence or history of other neoplasms (treated during the last five years prior to study entry) other than carcinoma in situ of the cervix or basal carcinoma of the skin
  -  Previously received photodynamic therapy for cholangiocarcinoma
  -  Previously undergone surgical resection of the cholangiocarcinoma
  -  Previously undergone chemotherapy, brachytherapy, or radiotherapy prior to entering the study
  -  Previously undergone metal stent insertion
  -  Porphyria or hypersensitivity to porphyrins (constituents of porfimer sodium), gemcitabine, cisplatin or other platinum-containing compounds
  -  Presence of infection other than the infection of the bile duct (cholangitis)
  -  Acute or chronic medical or psychological illnesses that prevent endoscopy procedures
  -  Abnormal blood test results
  -  Severe impairment of your kidney or liver function
  -  Decompensated cirrhosis
  -  Pregnant or intend to become pregnant, breastfeeding or intend to breast-feed during this study
  -  Participated in another drug study within 90 days before this one
  -  Unable or unwilling to complete the follow-up evaluations required for the study

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Hypofractionated Imrt (Vmat-Ra) For Elderly Patients With Newly Diagnosed High Grade Glioma

Summary: To assess the effect of IMRT using VMAT rapidarc approach, followed by adjuvant temozolomide on survival and quality of life in elderly, poor performance status patients with newly diagnosed HGG.

Detailed description: Investigators designed this study with the aim to assess the effect of IMRT using VMAT rapidarc approach, followed by adjuvant temozolomide on survival and quality of life in elderly, poor performance status patients with newly diagnosed HGG. The potential advantage of this approach is deliver a more selective irradiation to tumor's target with reducing the dose to normal brain and to allow the delivery of a higher dose, optimizing the therapeutic window.

Eligibility: Inclusion Criteria:
  -  Patients aged ≥ 70 years
  -  Karnosky performance status (KPS) ≤60
  -  Histologically confirmed HGG after tumor biopsy
  -  GBM
  -  Anaplastic Astrocytoma
  -  Anaplastic Oligoastrocytoma
  -  Anaplastic Oligodendroglioma without IDH1 mutation and no codeletion 1p19q
  -  Estimated survival ≥ 3 months.
  -  Normal liver, Kidney and bone marrow function
  -  Written informed consent
  Exclusion criteria:
  -  Prior radiation therapy
  -  Other primary cancer
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: VEGF Signaling Promotes Cell Growth and Metastasis in Extrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway (ECC)

Summary: The investigators study the VEGF signaling in ECC cell lines,patients and its mechanism in ECC growth, proliferation and apoptosis.

Detailed description: Several studies have documented the elevated expression of VEGF, VEGFR1 and VEGFR2 in cancer cell lines. Another study observed a sequential elevation of VEGF in low-grade dysplasia, high-grade dysplasia and early stage liver cancer. 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 ECC cells and its possible mechanism in regulating ECC growth.Therefore,we try to clarify the mechanism of VEGF signal in ECC growth,proliferation and apoptosis.

Eligibility: Inclusion Criteria:
  1. Extrahepatic cholangiocarcinoma patients diagnosed through biopsy; two or more dynamic imagine with a diagnosis of Extrahepatic cholangiocarcinoma
  2. Child-Pugh A or B
  3. well preserved renal and hematopoietic Function
  4. receive surgical therapy
  5. achieve complete section accessed by contrast-enhanced CT
  Exclusion Criteria:
  1. incomplete section
  2. remote metastasis
  3. Child-Pugh C
  4. combination with other hepatobiliary disease
  5. suffer from other tumors concurrently or in last five years

Relevance to patient case: not relevant