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

Clinical trial: Postprandial Fatty Acids and FABP2 in Type 2 Diabetes Mellitus (DM)

Summary: This study will be conducted in type 2 diabetic patient's to evaluate the if there is a different response of serum lipids after a standard meal (rich in saturated fatty acids) in patients who have the presence of a genetic alteration. This alteration that will be evaluated is a polymorphism, change of an amino acid in the gene of FABP2. This gene that can influence the absorption of lipids in the intestine and subjects who have the altered genotype (presence of T allele) can have an abnormal lipid profile as compared to subjects without this genotype.

Detailed description: Background: The presence of Ala54Thr polymorphism of intestinal fatty acid-binding protein 2 gene (FABP2) might influence the intestinal absorption of dietary fatty acids (FAs) and has been associated with diabetic nephropathy.
  Objective: We studied the postprandial serum FAs in type 2 diabetic patients homozygous for Thr54 (TT; n = 11) or for Ala54 (AA; n = 15) after a standard meal.Design: Patients received a sandwich (7.23 kcal/kg-total energy; 43.35% fat, 21.95% protein, and 34.70% carbohydrate) in the morning after 12-h fasting and FAs in chylomicrons (gas chromatograph), plasma glucose, and serum triacylglycerols were measured at 0, 2, 4, 6 and 8 h. Results: TT and AA patients did not differ regarding age (61.6±6.7 vs. 62.0±7.7years), diabetes duration (12.7±6.9 vs. 13.1±5.6years), male proportion (72.7 vs. 86.7%), blood pressure, type of diabetes treatment and previous macronutrients intake as well as serum A1C test (6.5±0.6 vs. 6.7±0.4%), LDL (3.0±1.0 vs. 3.2±0.6mmo/L), HDL (1.3±0.2 vs. 1.3±0.4mmol/L), triacylglycerols [1.6(1.0-3.4) vs. 1.6(0.6-3.7)mmol/L], saturated, monounsaturated, and polyunsaturated FAs, and trans-unsaturated FAs. The increase in serum glucose and triacylglycerols after the meal (ANOVA,P<0.001) was not different in both groups. The maximum increase of FAs occurred at 6-h postprandial, but only in TT patients: saturated FAs increased from 464.4(56.9-1602.5) to 1249.5(214.5-7149.8)mg/dL (P=0.041), monounsaturated FAs from 387.9(30.2-1523.8) to 925.1(344.6-5554.0)mgd/L (P=0.026), polyunsaturated FAs from 258.9(0-1048.5) to 713.1(143.7-7987.6)mg/dL (P=0.021), trans-unsaturated FAs from 18.5(1.9-70.6) to 66.5(5.0-451.7)mg/dL (P=0.023). Conclusion: The presence of the T allele of Ala54Thr polymorphism of FABP2 gene in type 2 diabetic patients increases absorption of dietary FAs, including the trans-unsaturated FAs, and this might turns these patients more susceptible to the effect of diet composition.

Eligibility: Inclusion Criteria:
  -  Type 2 diabetes
  -  homozygote to FABP2 polymorphism:TT or AA
  Exclusion Criteria:
  -  age >75 years
  -  glomerular filtration rate <30ml min-1
  -  with unstable angina or possible infarct or stroke in the last year

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

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: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

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: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers

Summary: To assess the feasibility of administering induction chemotherapy with gemcitabine and docetaxel followed by concurrent radiation and continuous infusion 5FU and consolidation gemcitabine/docetaxel chemotherapy.


Eligibility: Inclusion Criteria:
  -  Patients must have biopsy-proven, resected with curative intent cholangiocarcinoma, gallbladder, pancreatic or ampullary adenocarcinoma.
  -  Patients must be 18 years or older.
  -  Patients must have a NCI CTC Performance Status of 0-2.
  -  Patients must not have any prior chemotherapy or radiation therapy for this current malignancy.
  -  At least 3 weeks should have elapsed since any surgery requiring general anesthesia.
  -  Patients must have no prior malignancies except for basal or squamous skin cancers, cervical carcinoma-in-situ, unless in remission for >5years
  -  Pregnant patients are not eligible. Non-pregnant status will be determined in all women of childbearing potential. All patients will be required to use an effective means of contraception if sexually active during therapy.
  -  Initial Required Laboratory Values:
  -  Absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 150, 000/mm3, and hemoglobin ≥ 9 g/dL.
  -  Serum creatinine should be ≤ 2 mg/dL.
  -  Serum bilirubin should be ≤ 3.0 mg/dL (biliary stents allowed).
  -  Serum transaminases should be ≤ 5-fold the institutional upper limits.
  -  Patients must not have any co-existing severe medical illnesses, such as unstable angina, uncontrolled diabetes mellitus, uncontrolled arrhythmia or uncontrolled infection.
  -  Patients must be able to sign an informed consent.
  Exclusion Criteria:

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

Clinical trial: Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast Cancer

Summary: This is a Phase II, open label, non randomized correlative study of AZD2281 in patients with recurrent breast and ovarian cancer in both BRCA inherited mutation carriers and non-carriers to identify objective response rate and to assess for early markers of activity and to assess correlative markers that may provide helpful information for subsequent clinical trials. Approximately 110 patients from 7 centers in Canada will be enrolled into this study.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed high grade serous and/or undifferentiated carcinoma of ovary, fallopian tube or peritoneum
  -  Oestrogen, progesterone and HER2 negative advanced adenocarcinoma of the breast
  -  Known BRCA positive breast cancer or ovarian cancer, that is not high grade serous or undifferentiated tubo-ovarian carcinoma.
  -  Performance status of no more than 2.
  Exclusion Criteria:
  -  Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry
  -  Major surgery with 4 weeks of entering the study and must have recovered from effects of any major surgery .

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

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
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Hilar Cholangiocarcinoma

Summary: The purpose of this study is to compare the adequacy of unilateral endoscopic biliary drainage using metallic stent with plastic stent in unresectable, complex, hilar, cholangiocarcinoma and cost analysis.

Detailed description: There are two types of biliary stents: 1) the plastic stent made from polyethylene or polytetrafluoroethylene; and, 2) the metal stent braided in the form of a tubular mesh from surgical-grade stainless steel alloy and designed to expand to a maximum diameter of 10 mm. The main drawback of the plastic stent is the relatively high occlusion rate, but its advantage is the lower cost. The use of a metal stent for hilar tumor has many theoretical advantages: 1) the flexible open-mesh design should allow drainage of secondary duct branches; and, 2) its larger diameter may provide better drainage and longer patency (~3-9 months).
  Whether one type of stent is superior in terms of adequacy of drainage or cost-effectiveness remains undefined. Therefore, we would conduct this study to assess the efficacy of drainage of endoscopically-inserted, unilateral, plastic stents vs. metallic stents in unresectable, complex, hilar cholangiocarcinoma patients.

Eligibility: Inclusion Criteria:
  -  Unresectable complex hilar cholangiocarcinoma which diagnosis and staging based on computed tomography(CT) or magnetic resonance cholangiopancreatography (MRCP)
  Exclusion Criteria:
  -  Patients with ASA 4 or 5
  -  Patients with liver failure.
  -  Patients unable to comply with follow-up

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

Clinical trial: Surgical Treatment of Hilar Cholangiocarcinoma: Minor or Major Liver Resection?

Summary: The investigators conducted a prospective study to determine the safety and efficacy of minor and major hepatectomy selected by predetermined criteria in 138 patients with hilar cholangiocarcinoma. In selected patients, minor liver resection was a good treatment.

Detailed description: Objective: To determine the safety and efficacy of minor and major hepatectomy selected by predetermined criteria in patients with hilar cholangiocarcinoma (HC).
  Summary Background Data: For HC treated with hepatectomy, the extent of liver resection remains controversial despite extensive studies.
  Methods: From January 2000 to December 2007, we prospectively studied patients who received surgical treatment for HC. Of the 187 patients who were surgically treated, 138 (73.8%) underwent resection with a curative intent. Minor hepatectomy was carried out in 93 patients who had Bismuth-Corlette types I, II and III HC without hepatic artery/portal vein invasion; and major hepatectomy in 45 patients who had type III HC with hepatic artery/portal vein invasion, or type IV HC.

Eligibility: Inclusion Criteria:
  -  Criteria for resectability were absence of peritoneal or liver metastases, tumor extension to beyond secondary biliary branches bilaterally, tumor extension to secondary portal venous branches bilaterally
  Exclusion Criteria:
  -  not in accordance with the above criteria

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

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: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Quality of Life in Patients With Unresectable Hilar Cholangiocarcinoma on Palliative Metallic Stent Versus Plastic Stent

Summary: The purpose of this study is to compare the quality of life in patients with unresectable hilar cholangiocarcinoma on palliative metallic stent versus plastic Stent.

Detailed description: In the patient with unresectable hilar cholangiocarcinoma,palliative biliary stent is the one way to help him.
  The aim of palliative treatment is to improve quality of life and relief symptom,or sometime ,extended survival rate.
  There are two types of biliary stent:
  1. plastic stent made from polyethylene or polytetrafluoroethylene
  2. metalic stent braided in the form of a tubular mesh from surgical-grade stainless steel alloy and designed to expand to a maximum diameter of 10mm.
  The main drawback of plastic stent is relatively high occlusion rate, but its advantage is the lower cost.
  In the reasons of higher occlusion rate , the lower cost of plastic stent versus metallic stent that should be stent exchange when occluded, so we would to know about quality of life in both group.

Eligibility: Inclusion Criteria:
  -  All patient with diagnosis of hilar cholangiocarcinoma and/or radiological diagnosis
  -  Patient considered having an unresectable tumor or unfit of operation because of advanced age or medical illness
  Exclusion Criteria:
  -  Patient with ASA 4 or 5
  -  Patient who inability to comply with follow up
  -  Patient refused to join the research

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

Clinical trial: Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer

Summary: The primary objective of the trial is to determine the efficacy of VANDETANIB monotherapy or VANDETANIB plus GEMCITABINE or PLACEBO plus GEMCITABINE in prolonging the progression-free survival (PFS) at the trial closure in patients with advanced (unresectable or metastatic) biliary tract cancer.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically-confirmed advanced (unresectable or metastatic) biliary tract cancer (gallbladder cancer, cancer of the extrahepatic bile duct, intrahepatic cholangiocarcinoma and ampullary carcinoma)
  -  Patients must have measurable or evaluable but non-measurable disease
  -  Chemotherapy-naïve (prior chemotherapy in the adjuvant setting completed more than 3 months before the trial entry is accepted).
  -  WHO performance status 0 to 2: patients must have a WHO PS ≤ 2
  Exclusion Criteria:
  -  Patients must not have received prior systemic therapy for advanced (unresectable or metastatic) disease; prior chemotherapy in the adjuvant setting within 3 months before the trial entry is accepted
  -  Inadequate end-organ function or Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance wit
  -  Significant cardiovascular event (e.g. myocardial infarction, superior vena cava [SVC] syndrome, New York Heart Association [NYHA] classification of heart disease ³2) within 3 months before entry, or presence of cardiac disease that in the opinion of
  -  History of arrhythmia or QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG

Relevance to patient case: not relevant