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

Clinical trial: Evaluation of Stereotactic Radiosurgery For Liver Malignancies

Summary: This study is intended to establish the practicality of treating cancer in the liver with precisely administered single fractions of high-energy radiation using a radiosurgical (cross-firing) technique. A second purpose is to establish a safe dose for such therapy. Finally, the efficacy of radiosurgical ablation of liver tumors, in terms of radiographic response, will be measured.


Eligibility: Inclusion Criteria:All the following criteria must be met:
  -  Liver tumors not to exceed 5 cm in diameter. If this size can be increased at all, that would be beneficial as many liver lesions present at a larger size given the lack of symptoms until they are larger and adequate hepatic function with albumin >3.0, total bilirubin <3, INR 1.8. In the case of patients with known or 7 Dose Escalation Study Evaluating Stereotactic Radiosurgery for Liver Malignancies suspected cirrhosis, patients must have creatinine <1.5 and cannot have uncontrolled ascites, encephalopathy, active or recent gastrointestinal bleed (GIB).
  -  Age > 18 years old
  -  Histologically confirmed hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (IHCC), or metastatic adenocarcinoma of the breast/colon. Metastatic tumors of other histologic types or sites of origin may be included if the patients have a life expectancy of 6 months or greater. In the case of suspected HCC in patients with known cirrhosis, noninvasive criteria recommended by the European Association for the Study of Liver Diseases may be used. Hypervascular lesions > 2cm with alpha-fetoprotein (AFP) > 400ng/mL or hypervascular lesions >2cm on at least 2 imaging studies.
  -  Unresectable disease as determined by a surgeon
  -  Eastern Clinical Oncology Group performance status 0,1 or 2
  -  No chemotherapy within 1 month of registration
  -  No prior radiotherapy to the liver or upper abdominal area
  -  Life expectancy > 6 months
  -  Patients with IHCC or HCC with distant metastasis are not eligible for this study.
  -  For colon cancer patients with metastatic tumor of the liver who are not amenable to surgical resection due to the efficacy of removal of simultaneous lung and liver metastasis.
  Exclusion Criteria:- Children are excluded because HCC, IHCC, and hepatic metastases rarely occur in this age group. Furthermore, treatment requires a great deal of patient cooperation including the ability to lie still for several hours in an isolated room.
  - No laboratory personnel will be included.

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

Clinical trial: Effect of C-Peptide on Diabetic Peripheral Neuropathy

Summary: The aim of the study is to investigate the effect of C-peptide administration on nerve function in patients with type 1 diabetes and peripheral sensory neuropathy.

Detailed description: It has been observed that C-peptide administration results in an activation of renal tubular and sciatic endoneural Na/K-ATPase of the rat and stimulation of endothelial nitric oxide synthase. The hypothesis is that C-peptide administration may improve peripheral nerve dysfunction in diabetic neuropathy by increasing nerve blood flow and Na/K-ATPase activity. The purpose of the trial is to investigate the effect of C-peptide administration on diabetic peripheral sensory neuropathy in patients with type 1 diabetes and diabetic neuropathy in the lower extremities.

Eligibility: Inclusion Criteria:
  -  Subjects who have a duration of type 1 diabetes of more than 5 yrs
  -  Subjects who are C-peptide deficient
  -  Subjects who have diabetic distal symmetric neuropathy, according to the criteria defined at the San Antonio Conference on Diabetic Neuropathy 1988
  -  Subjects who have measurable action potential in the sural nerves
  -  Subjects who have reduced nerve conduction velocity in the sural nerves
  Exclusion Criteria:
  -  Subjects who have neuropathy or signs of nerve dysfunction which may be a consequence of factors other than type 1 diabetes
  -  Subjects who have concomitant medication that may interfere with the peripheral nerve function or measurement thereof
  -  Subjects who are transplanted (islet cell, kidney or pancreas)

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

Clinical trial: Feasibility of Radiotherapy and Concomitant Gemcitabine and Oxaliplatin in Locally Advanced Pancreatic Cancer and Distal Cholangiocarcinoma

Summary: The aim of the study is to evaluate the feasibility defined as overall tolerance and toxicity as well as relative dose-intensity and cumulative dose delivered, of an association ofgemcitabine, oxaliplatin and radiotherapy in patients with locally advanced and unresectable, but non-metastatic pancreatic adenocarcinoma or cholangiocarcinoma


Eligibility: Inclusion Criteria:
  -  Histologically proven and unresectable adenocarcinoma of the pancreas or cholangiocarcinoma with no evidence of metastatic disease
  -  WHO performance status of 0 or 1
  -  Complete recovrey from surgery in case an enteric and/or biliary tract by-pass operation has been performed
  -  Maximum delay after surgery: 8 weeks
  -  No previous or co-existent malignant disease except non melanoma skin cancers and adequately treated cervic carcinoma in situ
  -  Adequate bon marrow reserve
  -  No previous chemotherapy or radiotherapy
  -  Expected survival > 6 months
  Exclusion Criteria:
  -  Active infection
  -  Metastatic disease
  -  Inadequate liver function after derivative surgery
  -  Inadequate renal function
  -  Pregnancy, breast feeding
  -  Use of any other investigational agent in the month before enrollment
  -  Patients with grade 2 or more neuropathy

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

Clinical trial: Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients

Summary: This is an observational study intended to validate results of a previous study done at the Mayo Clinic. Patients are treated with combination chemotherapy and radiation and maintained on oral Xeloda until they can receive liver transplant. A staging laparotomy is performed before chemoradiation in order to identify patients who will most benefit from the treatment and to improve outcomes.


Eligibility: Inclusion Criteria:
  1. Diagnosis of cholangiocarcinoma that has been established preoperatively by at least one of the following criteria:
  1. A positive brush cytology or biopsy result obtained at the time of cholangiography;
  2. Fluorescence in situ hybridization demonstrating aneuploidy;
  3. A serum CA 19-9 value greater than 100 U/mL in the presence of a radiographically characteristic malignant stricture in the absence of cholangitis.
  2. Tumor/stricture is above the cystic duct and is unresectable.
  3. A suitable candidate for orthotopic liver transplantation as judged by a radiation oncologist, a medical oncologist, and the liver transplant team.
  4. >/= 18 years of age.
  5. Willing and able to provide written informed consent.
  Exclusion Criteria:
  1. Intrahepatic metastasis or other metastatic disease (except peri-hilar nodes).
  2. Prior treatment for this disease (including attempts at resection, irradiation, or chemotherapy)

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

Clinical trial: Chart Review: Unresectable/Metastatic Cholangiocarcinoma Treated With Irinotecan, Capecitabine and Celecoxib

Summary: Chart Review on Patients with unresectable/metastatic cholangiocarcinoma treated in the UNM Cancer Center with a combination of irinotecan, capecitabine and celecoxib.

Detailed description: As above.

Eligibility: Inclusion Criteria:
  -  Patients with unresectable/metastatic cholangiocarcinoma treated in the UNM Cancer Center with a combination of irinotecan, capecitabine and celecoxib.
  Exclusion Criteria:
  -  Not specified.

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

Clinical trial: Comparing Endoscopic Based Stent Strategy Versus Bypass Surgery in Non-resectable Periampullary Cancer

Summary: Randomized study comparing endoscopic stent insertion strategy versus double-bypass surgery in non-resectable periampullary cancer

Detailed description: Experience shows that patients with advanced periampullary cancer suffer not only from jaundice but in 25 -30% of cases also duodenal stricture with nausea, vomiting and nutritional difficulties. Ten years ago, the only palliative treatment for these patients was a bypass operation for bile flow and intestinal passage. This operation was often associated with a high morbidity. Developments in endoscopic treatments allow palliation with lower morbidity. However, stent treatment is not free of problems like stent dysfunction. During the last ten years, anesthesia and surgical techniques have developed which allow lower postoperative morbidity compared to earlier treatments. A total of 70 patients were randomized to surgery with hepaticojejunostomy on Roux loop and gastrojejunostomy or endoscopic treatment with self-expanding metallic stent in the bile duct and so-called duodenal stent. Based on the inclusion of 70 patients, we expected a 20% difference in some of the primary variables with a power of 80%.

Eligibility: Inclusion Criteria:
  -  Patients with a locally advanced periampullary neoplastic process with extrahepatic bile duct obstruction.
  -  The patient tumor burden and general condition should be such that treatment related morbidity and mortality is calculated as "reasonable" and both treatment strategies are considered "applicable".
  Exclusion Criteria:
  -  Non consent.
  -  The patients' general condition will not tolerate either treatment (strategy).
  -  Previous laparotomy or laparoscopy.
  -  Life expectancy < 3 months.
  -  Inability to participate (language, social, etc.)

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

Clinical trial: Radiation Therapy as Palliative Treatment of GIST

Summary: Gastrointestinal stromal tumors (GISTs) are generally considered resistant to radiation, but no prospective trials addressing efficacy and tolerability of radiation therapy have been carried out. Limited clinical experience suggests that selected GIST patients may benefit from palliative radiation therapy. The purpose of this prospective, non-randomized, multicenter study is to evaluate efficacy and safety of palliative radiation therapy in GIST patients who have progressive GIST during or after tyrosine kinase inhibitor therapy.

Detailed description: Radiation therapy planning must be based on computerized tomography (CT). External beam radiation must be used. Both 3D and IMRT plans are acceptable. The cumulative radiation dose may range from 30 to 40 Gy as administered in 1.8 to 2.0 Gy fractions, 5 fractions per week. The dose is specified as defined by the ICRU (International Commission on Radiation Units and Measurements) report 50. Response is evaluated using CT 6 and 12 weeks after irradiation. Adverse effects are evaluated using the Common Terminology Criteria for Adverse Effects (CTCAE)version 3.

Eligibility: Inclusion Criteria:
  -  Histologically verified GIST.
  -  Metastatic or locally advanced, inoperable disease.
  -  Adequate systemic treatment has been administered.
  -  One or more growing GIST metastasis present during of after TKI therapy.
  -  The target lesion(s) is measurable.
  -  A written informed consent
  Exclusion Criteria:
  -  WHO performance status is 4.
  -  Estimated life-expectancy less than 3 months.
  -  Radiation planning target volume greater than 3 dm3.
  -  Unmeasurable target lesion. Bone and brain metastases are not accepted target lesions.
  -  Radiation therapy cannot be delivered (e.g. active infection or restlessness.)
  -  Pregnancy.
  -  Systemic GIST treatment with unknown efficacy.
  -  Copies of CT images cannot be sent for central review.

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

Clinical trial: RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.

Summary: Biliary atresia is a congenital disorder of bile duct development or destruction of established but immature bile ducts. The study tests the hypothesis that post-operative steroids improve outcome following the Kasai procedure - the commonest surgical treatment.

Detailed description: Biliary atresia is a potentially fatal condition of infants presenting as persisting jaundice in the first few weeks of life. The disease is characterised by obstruction and damage to the intra and extrahepatic parts of the biliary tree. Within the liver there is also a pronounced inflammatory response. The initial treatment is an attempt, by surgery, to restore bile flow by excising the obliterated extrahepatic bile ducts and joining part of the intestine to the bile "root" of the liver (the porta hepatis). This is known as the Kasai procedure. This is successful in ~50% of cases in reducing the level of jaundice to near-normal values. The use of steroids post-operatively has been suggested as improving outcome by diminishing the inflammatory response.

Eligibility: Inclusion Criteria:
  -  biliary atresia
  Exclusion Criteria:
  -  <100 days at portoenterostomy
  -  no other anomalies (e.g. Biliary Atresia Splenic Malformation syndrome)
  -  anu contra-indications to corticosteroids

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

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

Clinical trial: Randomized Controlled Trial on Pancreatic Stent Tube in Pancreaticoduodenectomy

Summary: The purpose of this study is to determine which stent type is effective in the decrease of postoperative stay and complications across pancreaticojejunostomy after pancreaticoduodenectomy.

Detailed description: This study compared the postoperative hospital stay and complications of lost stent with external stent after pancreaticoduodenectomy. The complications of pancreaticoduodenectomy are important to affect the postoperative course, and, a stent tube often places across pancreaticojejunostomy to reduce complications. However, there is no report that demonstrates the postoperative course between pancreatic stent types. We conducted a prospective randomized trial on 100 patients who underwent pancreaticoduodenectomy comparing external stent and lost stent.
  The primary endpoint was defined as postoperative hospital stay. The secondary endpoints were mortality and morbidity, including pancreatic fistula, delayed gastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess. Patients were recruited into this study before surgery, on the basis of whether pancreatic head resection was anticipated at WMUH for pancreatic head and periampullary disease, and appropriate informed consent was obtained. Exclusion criteria was 1) patients with severe complications which were possible to prolong hospital stay, 2) patients who were diagnosed inadequacy for this study by a physician, 3) patients who could not be placed a pancreatic stent tube, and 4) patients without an informed consent.

Eligibility: Inclusion Criteria:
  -  On the basis of whether pancreatic head resection was anticipated at WMUH for pancreatic head and periampullary disease, and appropriate informed consent was obtained.
  Exclusion Criteria:
  -  Patients with severe complications which were possible to prolong hospital stay
  -  Patients who were diagnosed inadequacy for this study by a physician
  -  Patients who could not be placed a pancreatic stent tube
  -  Patients without an informed consent.

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

Clinical trial: Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy

Summary: The purpose of this study is to clarify whether resecting pylorus-ring decreases delayed gastric emptying after pancreaticoduodenectomy and improves postoperative quality of life (QOL).

Detailed description: The purpose of this study is to clarify whether resecting pylorus-ring decreases delayed gastric emptying after pancreaticoduodenectomy and improves postoperative quality of life(QOL)compared with preserving pylorus-ring. Delayed gastric emptying after pancreaticoduodenectomy are important to affect the postoperative course and QOL. However, there is no report that demonstrates the postoperative course between resecting pylorus-ring and preserving pylorus-ring. We conducted a prospective randomized trial on 130 patients who underwent pancreaticoduodenectomy comparing resecting pylorus-ring and preserving pylorus-ring.
  The primary endpoint was defined as the decrease of delayed gastric emptying. The secondary endpoints were QOL, mortality and morbidity, including pancreatic fistula, intra-abdominal hemorrhage, and intra-abdominal abscess. Patients were recruited into this study before surgery, on the basis of whether pancreatic head resection was anticipated at Wakayama Medical University Hospital(WMUH) for pancreatic head and periampullary disease, and appropriate informed consent was obtained. Exclusion criteria was 1) patients with severe complications which were possible to prolong hospital stay, 2) patients who were diagnosed inadequacy for this study by a physician, 3) patients with a previous gastric resection, and 4) patients without an informed consent.

Eligibility: Inclusion Criteria:
  -  On the basis of whether pancreatic head resection was anticipated at WMUH for pancreatic head and periampullary disease, and appropriate informed consent was obtained.
  Exclusion Criteria:
  -  Patients with severe complications which were possible to prolong hospital stay
  -  Patients who were diagnosed inadequacy for this study by a physician
  -  Patients who could not be placed a pancreatic stent tube
  -  Patients without an informed consent.

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

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

Clinical trial: Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma

Summary: In patients with cholangiocarcinoma therapeutic effects have been reported for Gemcitabine/Oxaliplatin. Furthermore, photodynamic therapy (PDT) has significantly improved patients survival in two randomised trials. PDT induces tumor necrosis only in an area of few millimetres, while tumor parts which are located beyond this area remain untreated. An additive effect could result from PDT as a local therapy in combination with systemic chemotherapy.

Detailed description: Patients entered in the study receive a sequential therapy consisted of photodynamic therapy followed by systemic chemotherapy (Gemcitabine/Oxaliplatin) 4 weeks later. Systemic chemotherapy every 2 weeks is scheduled 9 times in each cycle. Thereafter, another cycle of PDT followed by chemotherapy is intended.

Eligibility: Inclusion Criteria:
  -  Histologic/cytologic verified cholangiocarcinoma or cholangiocarcinoma-typical findings in >= 2 diagnostic methods
  -  Bile duct stenoses which are technically successful treated with biliary drainage
  -  Irresectability/inoperability
  -  Karnofsky-Index >= 60%
  -  Age >= 18
  -  Written consent
  Before chemotherapy:
  -  Bilirubin <= 5 mg/dl
  -  GOT/GPT < 5x upper standard
  -  Creatinine < 2x upper standard
  -  Thrombocytes > 100 G/l
  -  Neutrophils > 2,00 G/l
  -  Haemoglobin > 9 g/dl
  -  No occurence of complications during endoscopic procedures (abscess, bilioma, cholecystitis, cholangitis, pancreatitis, biliary leakage)
  Exclusion Criteria:
  -  Implantation of a metal stent in the bile duct
  -  Previous PDT or chemotherapy
  -  Neoplasia
  -  Porphyria
  -  Pregnant or breastfeeding women
  -  Women of childbearing age and potent men who are not using highly effective contraceptives

Relevance to patient case: not relevant