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

Clinical trial: Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells left after surgery.
  PURPOSE: Phase II trial to study the effectiveness of combining fluorouracil and radiation therapy in treating patients who have undergone surgery for pancreatic cancer.

Detailed description: OBJECTIVES:
  -  Determine the tolerance of adjuvant fluorouracil with concurrent radiotherapy in patients with resected pancreatic adenocarcinoma.
  -  Determine survival without local relapse in these patients treated with this regimen.
  -  Determine overall survival of these patients treated with this regimen.
  -  Determine the effectiveness of this adjuvant therapy in these patients.
  OUTLINE: This is a multicenter study.
  Patients receive high-dose radiotherapy 5 days a week for 5 weeks. Patients also receive low-dose radiotherapy 4 times a week during the last 2 weeks of the 5-week course of treatment. Patients concurrently receive fluorouracil IV continuously for 5 weeks in the absence of disease progression or unacceptable toxicity.
  Patients are followed for survival.
  PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed pancreatic adenocarcinoma
  -  Complete macroscopic resection of tumor within past 30 days
  -  No residual visceral or peritoneal metastasis
  -  Involvement of Vater's ampulla or extrahepatic bile duct allowed
  -  No vesicular or intrahepatic cholangiocarcinomas
  PATIENT CHARACTERISTICS:
  Age:
  -  18 to 75
  Performance status:
  -  ECOG 0-2
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Absolute neutrophil count greater than 1,500/mm^3
  -  Platelet count greater than 100,000/mm^3
  Hepatic:
  -  Alkaline phosphatase less than 3 times normal
  -  Bilirubin less than 1.5 times normal
  Renal:
  -  Creatinine less than 1.5 times normal
  Cardiovascular:
  -  No serious cardiac failure
  Pulmonary:
  -  No serious respiratory failure
  Other:
  -  No other untreatable malignant tumors
  -  No serious psychological, familial, social, or geographical conditions that would preclude study
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  No prior chemotherapy for pancreatic adenocarcinoma
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  No prior radiotherapy for pancreatic adenocarcinoma
  -  No prior radiotherapy in an anatomically proximal region to treatment area
  Surgery:
  -  See Disease Characteristics

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

Clinical trial: Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
  PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, leucovorin, and fluorouracil in treating patients who have locally advanced or metastatic cancer of the pancreas or bile duct.

Detailed description: OBJECTIVES: I. Determine the response rate, in terms of WHO objectives and clinical benefit, in patients with locally advanced or metastatic pancreatic or biliary adenocarcinoma treated with gemcitabine, leucovorin calcium, and fluorouracil. II. Determine the tolerance of this regimen in this patient population. III. Determine the survival without disease progression in patients treated with this regimen. IV. Determine the overall survival in patients treated with this regimen.
  OUTLINE: This is a multicenter study. Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours on day 1 followed by gemcitabine IV over 80-150 minutes on day 2. Treatment repeats every 2 weeks for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response may continue chemotherapy for up to 1 year. Patients with locally advanced disease after 3 months of chemotherapy may receive concurrent radiotherapy with chemotherapy for 5 weeks, or may undergo surgical resection. Fluorouracil-based chemotherapy (with or without radiotherapy) may then resume after surgery. Patients are followed for survival.
  PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed pancreatic or biliary duct adenocarcinoma Metastatic or locally advanced No cerebral metastasis Surgically unresectable
  PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: ECOG 0-2 Life expectancy: More than 12 months Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Alkaline phosphatase less than 5 times normal Bilirubin less than 1.5 times normal Renal: Creatinine less than 1.5 times normal No uncontrolled or persistent hypercalcemia Cardiovascular: No severe cardiac failure Pulmonary: No severe respiratory failure Other: No other malignant tumor considered incurable or untreatable No uncontrolled pain No psychological, familial, social, or geographical reasons that would preclude study
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent corticosteroids except as antiemetic Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

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

Clinical trial: Counseling Interventions for BRCA 1/2 Cancer Susceptibility Testing

Summary: To evaluate two different ways of providing information about genetic testing for BRCA1 and BRCA2 alterations. The two forms of counseling are genetic counseling and enhanced informed consent which cover similar material but are organized differently.

Detailed description: -  Patients will have a blood sample drawn that will be analyzed for altered BRCA1 or BRCA2 genes. An alteration of BRCA1 or BRCA2 gene means there is an increased risk of developing breast and ovarian cancer.
  -  Patients participating in this study have either: 1) expressed an interest in testing for an underlying genetic factor that may account for the breast or ovarian cancer in their family; 2) have at least one relative that has been found to have a BRCA1 or BRCA2 alteration; 3) have a personal or family history of breast or ovarian cancer that is suggestive of a BRCA1 and BRCA2 alteration; or 4) has breast or ovarian cancer, or has at least one close relative with a history of breast or ovarian cancer and are a member of an ethnic group with increased frequency of BRCA1 and BRCA2 alterations.
  -  Patients will be randomized into one of two counseling groups. Two visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent. These visits will be audio-taped to monitor how the project staff is covering the important information about testing.
  -  Throughout this study patients will be asked to complete questionnaires and psychological measures. These forms will be completed before and after the first visit, and a subset of them again at 2-4 weeks after the second visit, and at 4, 6, and 12 months.
  -  In addition 30 women will be asked to complete a 20-30 minute telephone interview with the program psychologist.

Eligibility: Inclusion Criteria:
  -  18 years of age or older
  -  Member of a family in which a BRCA1 or BRCA2 deleterious germline mutation has been identified, whether or not the individual has had cancer herself; written documentation of the family mutation must be available for laboratory purposes during the testing process.
  -  Personal and/or family history of breast/ovarian/other cancer consistent with BRCA 1/2 heredity with posterior probability of carrying an altered gene
  -  Documentation of key family member cancer diagnoses is required
  Exclusion Criteria:
  -  Males, will be offered BRCA 1/2 testing through other protocols
  -  Individuals unable to speak or write English
  -  Already participated in a genetic counseling program for BRCA1 or BRCA2 testing
  -  Life expectancy of less than 12 months.

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

Clinical trial: Effects of Miglitol on Daily Plasma Glucose in type2 Diabetes Treated With Insulin

Summary: In this study, the effect of miglitol on daily plasma glucose will be evaluated in type 2 diabetic patients treated with insulin.


Eligibility: Inclusion Criteria:
  -  type2 diabetes
  -  postprandial plasma glucose levels ≧180mg/dl
  Exclusion Criteria:
  -  type1 diabetes
  -  AST(GOT) or ALT(GPT) ≧100IU/l
  -  creatinine ≧2.0mg/dl

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

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

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

Clinical trial: Priapism in Boys and Men With Sickle Cell Disease - Demographics, Characteristics and Prevalence

Summary: Priapism, a prolonged erection of the penis, is a medical issue that often affects men with sickle cell disease. The purpose of this study is to collect demographic and clinical information on priapism by interviewing men with sickle cell disease.

Detailed description: Priapism is a prolonged, painful erection of the penis that lasts for more than four hours and occurs without sexual stimulation. It occurs when blood in the penis becomes trapped and is unable to drain properly. If it is not treated immediately, it can lead to scarring and permanent erectile dysfunction. Many cases of priapism are the result of sickle cell disease; approximately 42% of all adults with sickle cell disease will eventually develop priapism. Current treatments include medication, ice packs, or surgery. More research is needed to better understand the demographic and clinical characteristics of priapism. The purpose of this study is to collect information and further characterize priapism by conducting interviews with men with sickle cell disease. In turn, these findings may guide future priapism clinical trials.
  This study will consist of two standardized questionnaires that will be administered to 1,650 men with sickle cell disease. Participants will complete an initial five-item questionnaire about priapism. If a participant indicates past experience with priapism on this initial questionnaire, he will be asked to complete a second questionnaire. This questionnaire will ask in-depth questions to further characterize the participant's episodes of priapism. If health issues such as drug use, harmful sexual behaviors, or impotence are identified upon reviewing the questionnaire, clinic staff will suggest care options and provide appropriate referrals to the participants. All participants will receive an educational brochure about priapism and compensation for completing the questionnaires.

Eligibility: Inclusion Criteria:
  -  Diagnosis of sickle cell anemia or sickle beta zero thalassemia, if 5 years of age or over OR
  -  Diagnosis of sickle beta plus thalassemia or sickle hemoglobin C disease, if 15 years of age or over
  -  Participant and/or parent or guardian must be able to communicate adequately with the interviewer
  -  May participate if currently taking hydroxyurea, undergoing chronic transfusion, or participating in other research studies, including those involving treatments such as arginine, if all other inclusion criteria are met
  Exclusion Criteria
  Subjects who meet any of the following criteria are disqualified from enrollment in the study:
  1. Patient or parent/guardian declines participation.
  2. Female.
  3. Subject or parent/guardian unable to communicate adequately with the interviewer.

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

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

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

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

Clinical trial: Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer

Summary: The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for whom no curative therapeutic option exists.


Eligibility: Inclusion Criteria:
  -  Advanced ovarian cancer with positive BRCA1 or BRCA2 status
  -  Failed at least one prior chemotherapy
  -  In investigators opinion, no curative standard therapy exists
  -  Measurable disease
  Exclusion Criteria:
  -  Brain metastases
  -  Less than 28 days since last treatment used to treat the disease
  -  Considered a poor medical risk due to a serious uncontrolled disorder

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

Clinical trial: Testosterone for Peripheral Vascular Disease

Summary: There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels in men. Testosterone treatment has shown beneficial effects on blood sugar control and obesity in pilot studies in men with type 2 diabetes. Beneficial effects have also been seen on angina- a disease related to atherosclerosis (narrowing of the arterial blood vessels). Peripheral vascular disease is also caused by atherosclerosis. We hypothesise that testosterone will have beneficial effects on peripheral vascualr disease in men with low serum testosterone and type 2 diabetes.


Eligibility: Inclusion Criteria:
  1. Type 2 diabetes mellitus.
  2. Serum testosterone 12 nmol/L or less on two consecutive samples taken on different days and symptoms compatible with hypogonadism.
  3. Peripheral vascular disease as defined by
  -  previous diagnosis by a specialist vascular surgeon OR
  -  ABPI less than 0.92 and ischaemic leg pain (claudication or rest pain) or distal complications (non-healing arterial foot ulcer or gangrene).
  4. Agreement to maintain antihypertensive and antilipid treatments at prior doses during 3 month duration of study.
  5. Ability to give written informed consent after verbal and written explanation in the English language.
  6. Ability to comply with all study requirements.
  Exclusion Criteria:
  1. Current or previous breast cancer.
  2. Current or previous prostate cancer.
  3. Raised prostate specific antigen (PSA) or abnormal per rectal examination unless prostate cancer excluded after specialist urology opinion.
  4. Severe symptoms of benign prostatic hypertrophy (‘prostatism’)
  5. Treatment with testosterone in the 3 months prior to the trial.
  6. Investigational drug treatment in the 3 months prior to the trial.

Relevance to patient case: not relevant