araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Chemotherapy Treatment for Children With Intraocular Germ-Line Retinoblastoma

Summary: Retinoblastoma is an unusual cancer of early childhood involving tumor is both eyes or, in certain circumstances, one eye only. This condition is the result of an abnormal gene which makes both retinas (the back of the eye) vulnerable to develop multiple tumors. Growths in the eye impair vision temporarily or permanently. These tumors are malignant, which means that they can grow within the eye, spread outside of the eye, and be fatal if untreated.
  Standard therapy for bilateral retinoblastoma includes removal of one eye if vision cannot be save and radiation treatment of either eye in which vision might be saved. Radiation controls tumor growth in the majority of cases. Another standard method is cryotherapy (freezing a tumor to kill it). Chemotherapy (medicines used to kill tumor cells) has been used in the past for tumor in or outside the eye, but is not standard. Hyperthermia, increasing the temperature of a tumor to kill it, is widely performed, and can be done to a retinoblastoma tumor by a laser; this method is not standard.
  The problem with removal of an eye is that any hope of vision is lost. The problems with radiation include incomplete control of tumor, injury to the eye or surrounding tissue with decreased growth, and that (due to the abnormal retinoblastoma gene) children are very susceptible to develop other tumors, especially in the tissue which was given radiation.
  The doctors at Children's Memorial Hospital are using a newer form of treatment, including laser hyperthermia, chemotherapy and cryotherapy to decrease retinoblastoma tumors. Some may be controlled indefinitely, reducing the number of eyes that need radiation or removal.
  OBJECTIVES
  1. To find out how well chemotherapy plus cryotherapy and laser hyperthermia work on retinoblastoma tumors.
  2. To find out whether vision can be saved and tumors controlled without radiation or removal of the eye.


Eligibility: Eligibility Criteria:
  -  Initial clinical diagnosis of Retinoblastoma, with Bilateral tumors, OR Unilateral tumor with hope for salvage of vision AND Multiple primary tumors, or positive family history for retinoblastoma, or age < 12 months
  -  No prior antitumor therapy (except enucleation of one eye)
  -  At least one tumor exceeds 6 mm in diameter
  -  No evidence of dissemination outside the globe
  -  Signed IRB-approved informed consent
  -  Patient/family available for follow-up

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Genetic Epidemiological Study of Lung Cancer in Taiwan and Clinical Applications

Summary: Lung adenocarcinoma in Chinese females is hypothesized to be determined by both genetic and environmental factors. In this grant proposal, we propose to map the loci of susceptibility genes of female lung adenocarcinoma based on multiplex families recruited in Taiwan. We focus on a unique pathological type of a unique population in order to reduce heterogeneity of the genetic background. Compared with western women, female Chinese population has a high prevalence of lung adenocarcinoma. Our reasoning is that if we focus on a specific sub-type, which has a familial basis, we will increase the probability of identifying genes associated with female lung adenocarcinoma. The primary goal of this study is to identify the genetic and environmental determinants of female lung adenocarcinoma, and study the relationship between gene polymorphisms and clinical manifestation profiling of lung cancer.

Detailed description: This research proposal intends to integrate epidemiologists, biostatisticians, clinicians, molecular biologists/geneticists to identify susceptible genes for lung cancer, especially for female lung adenocarcinoma, and to study the relationship between gene polymorphisms and clinical outcomes of lung cancer patients. Our objective is to find gene markers for developing useful screening tools for the high risk group in order to prevent or early detect lung cancer, especially female lung adenocarcinoma.
  The specific aims of this subproject include:
  1. Establish and maintain the research network that will recruit and follow up the subjects and families for the GEFLAC study; keeping control of the progress of the study.
  2. Coordinate all the subprojects such as integrating genotyping data with clinical data and environment data.
  3. Continue to employ the candidate gene approach to examine the contribution of specific genes to the lung cancer.
  4. Generate genotyping data for candidate genes in the exploring stage and prioritize SNPs of candidate genes for large scale studies.
  5. Identify susceptible genes/candidate genes to develop multiplex PCR for screening.

Eligibility: Inclusion Criteria:
  -  lung adenocarcinoma
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Determinants of Vitamin K Metabolism

Summary: The purpose of this study is to learn how the body responds to different amounts of vitamin K in the diet in order to understand the roles that vitamin K may have in the body. We also need to determine if older adults need more or less vitamin K in their diet compared to younger adults in order to maintain normal body stores of vitamin K.

Detailed description: Vitamin K has a role in bone health, but little is known about vitamin K metabolism in aging and in maintenance of bone mass. The limited understanding of vitamin K metabolism impedes the establishment of dietary recommendations for vitamin K, and the interpretation of results from clinical trials on vitamin K supplementation and bone health of women in a narrow age group. This study is the first to assess the role of dietary and other factors that influence the response to vitamin K status and bone turnover to vitamin K depletion and repletion in adults. This study also compares the absorption efficiency and body retention of vitamin K relative to current vitamin K status. Men and women [21 younger (18-40y) and 21 older (55+y)] will participate in a 62-d metabolic study, with a 5d run-in period, followed by a 28d dietary vitamin K restriction period (10 ug/d), and ending with a 28d dietary vitamin K supplementation period (500 ug/d). Coagulation times will be monitored during the dietary restriction period. Serial measurements of vitamin K status markers and of bone turnover markers will show the response of vitamin K to dietary manipulation for both age groups under identically controlled dietary conditions. Deuterium-labeled vitamin K in collards will be used to compare the absorption of vitamin K during a vitamin K-deplete state to that of a vitamin K-replete state. Vitamin K is transported in triglyceride-rich lipoproteins, which may vary among individuals due to differences in adiposity and lipid homeostasis. Therefore, measurement of body composition by Dual Energy X-Ray Absorptiometry (DXA) and plasma lipids will provide insight into the role of lipids in absorption and transport of vitamin K. The findings of this study are critical for the interpretation of the epidemiologic and clinical data used to determine the protective role vitamin K may have in chronic disease prevention.

Eligibility: Inclusion Criteria:
  Exclusion Criteria:
  -  kidney, GI, or liver disease requiring treatment
  -  prescribed osteoporosis medications in the previous 3 months
  -  use of acid reducers more than twice per week
  -  blood clotting disorder and/or abnormal clotting time
  -  warfarin or anticoagulant use in the previous 12 months
  -  diabetes
  -  smoking
  -  hormone therapy in the previous 3 months
  -  oral contraceptive use in the previous 3 months; pregnancy
  -  strict vegetarian diet

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Retinoblastoma Biomarker Study

Summary: A series of 1,729 retinoblastoma (RB) patients were identified from medical records at hospital centers in Boston (1937-84) and New York (1914-84). The study cohort consists of the 1,604 patients who survived at least 1 year after RB diagnosis. Information was obtained from medical records and interviews conducted in 1987 and 1993. RB patients had a 30-fold excess risk of another cancer, and a 50% chance of developing a cancer if they survived to 50 years of age. Blood samples have been collected from 481 patients, and studies are underway to determine if certain mutations in the RB1 genes are associated with increased or decreased penetrance or with increased risk of subsequent cancer development. The study population in New York is being expanded currently to include patients treated since 1984, and their medical records are being abstracted. Blood samples will be collected from the newly identified patients who are returning to New York Hospital for a followup RB exam.

Detailed description: A series of 1,729 retinoblastoma (RB) patients were identified from medical records at hospital centers in Boston (1937-84) and New York (1914-84). The study cohort consists of the 1,604 patients who survived at least 1 year after RB diagnosis. Information was obtained from medical records and interviews conducted in 1987 and 1993. RB patients had a 30-fold excess risk of another cancer, and a 50% chance of developing a cancer if they survived to 50 years of age. Blood samples have been collected from 481 patients, and studies are underway to determine if certain mutations in the RB1 genes are associated with increased or decreased penetrance or with increased risk of subsequent cancer development. The study population in New York is being expanded currently to include patients treated since 1984, and their medical records are being abstracted. Blood samples will be collected from the newly identified patients who are returning to New York Hospital for a followup RB exam.

Eligibility: -  INCLUSION CRITERIA:
  Children treated for retroblastoma over the past 30-plus years.

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising

Summary: The objective of this study is to assess the comparative utility of topical formulations in hastening the resolution of skin bruising. For each subject, four standard bruises of 7 mm diameter each were created on the bilateral upper inner arms, 5 cm apart, two per arm, using a 595-nm pulsed-dye laser. Randomization was used to assign one topical agent (5% vitamin K, 1% vitamin K and 0.3% retinol, 20% arnica or white petrolatum) to exactly one bruise per subject, which was then treated under occlusion twice a day for 2 weeks. A dermatologist rated bruises in standardized photographs immediately after bruise creation and at week 2.


Eligibility: Inclusion Criteria:
  -  Age 20-60
  -  Subjects are in good health.
  -  Subjects have willingness and the ability to understand and provide informed consent for participation in the study.
  Exclusion Criteria:
  -  Subjects who are currently using any anticoagulation therapy (Warfarin, Heparin, Aspirin)
  -  Subjects who have a history of bleeding disorders.
  -  Subjects who are unable to understand the protocol or to give informed consent
  -  Subjects with mental illness
  -  Subjects who are pregnant or nursing.
  -  Subjects who have active systemic or local infection
  -  Subjects with systemic or local skin disease.
  -  Subjects with systemic illness.

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Changes in Muscle Tissue in Patients With Pancreatic Cancer

Summary: RATIONALE: Measuring changes in muscle tissue in patients with cancer may help doctors predict how well patients will respond to treatment, and may help the study of cancer in the future.
  PURPOSE: This pilot study is evaluating changes in muscle tissue in patients with pancreatic cancer.

Detailed description: OBJECTIVES:
  -  Demonstrate a decrease/increase of fat-free mass (FFM) by 10% from baseline, based on tumor progression/regression, within each patient with inoperable locally advanced or metastatic pancreatic carcinoma.
  -  Determine the correlation between changes in FFM and 6-month survival.
  -  Confirm the frequency of lymphocytopenia in patients with inoperable locally advanced or metastatic pancreatic carcinoma.
  -  Demonstrate an interaction between pretreatment total lymphocyte count, treatment response, and 6-month survival in patients with inoperable locally advanced or metastatic pancreatic carcinoma.
  -  Collect adjuvant information, such as weight, body mass index, age, ECOG performance status, gait speed, concomitant medications, CA19-9, and total lymphocyte count, in these patients.
  OUTLINE: This is a pilot study.
  Patients will have weight, body mass index, age, ECOG performance status, gait speed, concomitant medications, CA19-9, and total lymphocyte count measured before start of cancer treatment of the patient's choosing.
  Patients will be re-assessed at approximately 2 months, 4 months, 6 months, and with any change in tumor burden.
  PROJECTED ACCRUAL: A total of 17 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Biopsy-proven inoperable locally advanced or metastatic pancreatic adenocarcinoma
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-3
  -  Must be able to stand unassisted on a scale
  -  Must not have pacemaker or implanted defibrillator
  PRIOR CONCURRENT THERAPY:
  -  Prior chemotherapy or radiotherapy allowed
  -  No concurrent use of any of the following:
  -  Corticosteroids
  -  Steroids as anti-emetics associated with chemotherapy allowed
  -  Anabolic steroids
  -  Thalidomide
  -  Megesterol
  -  Eicosapentaenoic acid (EPA)
  -  Nutritional supplements without EPA allowed
  -  Juven
  -  Concurrent enrollment in other clinical trials allowed

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas

Summary: The intention of this trial is to evaluate safety and efficacy of a combination treatment of EndoTAG-1 with Gemcitabine versus Gemcitabine monotherapy.


Eligibility: Inclusion Criteria:
  -  Inoperable adenocarcinoma of the pancreas
  -  Histologic or cytologic confirmation
  -  At least 18 years of age
  Exclusion Criteria:
  -  Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrollment
  -  Major surgery within 4 weeks prior to enrollment
  -  Major cardiovascular disease

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer

Summary: The purpose of this research study is to investigate if RAD001 is an effective treatment for pancreatic cancer that has spread and not responded to treatment. Experiments have shown that RAD001 can prevent cells from multiplying. RAD002 has also been tested in laboratory experiments imitating cancer conditions and the results have been promising.

Detailed description: -  Participants taking part in this research study will be given a study medication-dosing calendar for each treatment cycle. Each cycle lasts four weeks during which you will be taking the study drug, RAD001, orally every day.
  -  Participants will come into the clinic every other week during the time of enrollment. At each clinic visit blood work will be taken to monitor the participants health and a physical exam will be performed. CT scans will be repeated every 2 months to assess the tumor.
  -  Participants will remain on the study as long as they continue to benefit from the study medication.

Eligibility: Inclusion Criteria:
  -  Pathologic confirmation of pancreatic adenocarcinoma
  -  18 years of age or older
  -  At least one measurable site of disease according to RECIST criteria that has not been previously irradiated. If patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation.
  -  Treated with gemcitabine-based chemotherapy with documented tumor progression on gemcitabine or intolerance to gemcitabine.
  -  Prior treatment with no more than 1 prior chemotherapy regimen for metastatic disease.
  -  Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anti-cancer therapy.
  -  ECOG performance status 0-1.
  -  Life expectancy of greater than 12 weeks.
  -  Adequate bone marrow and liver function.
  -  Must be able to swallow tablets.
  Exclusion Criteria:
  -  Prior treatment with an investigational drug within the preceding 4 weeks.
  -  Prior treatment with an inhibitor of mTOR
  -  Chronic treatment with systemic steroids or another immunosuppressive agent
  -  More than one prior chemotherapy treatment for metastatic disease
  -  Uncontrolled brain or leptomeningeal metastases, including patient who continue to require glucocorticoids for brain or leptomeningeal metastases.
  -  Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
  -  Patients with chronic renal insufficiency
  -  Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study.
  -  Known history of HIV seropositivity
  -  Impairment of gastrointestinal function or gastrointestinal disease that my significantly alter the absorption of RAD001.
  -  Active, bleeding diathesis or an oral vitamin K antagonist medication
  -  Women who are pregnant or breast feeding

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Outcome of Pancreatic Stump Closure Following Resection of Tumors of the Head of the Pancreas.

Summary: Chart review evaluating outcome of patients in whom following resection of a tumor involving the head of the pancreas no anastomosis of the pancreatic stump was done to the gastrointestinal tract.


Eligibility: Inclusion Criteria:
  -  Pathologically proven carcinoma of the head of pancreas or other periampullary carcinoma treated by pancreaticoduodenectomy.
  Exclusion Criteria:
  -  Patients undergoing pancreaticoduodenectomy for other indications (i.e. trauma)
  -  Charts not available for review.

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Proteomic Analysis of HLA Complex in Solid Cancers: Breast, Ovary, Colon, Rectum, Stomach, and Pancreas

Summary: The purpose of this study is to evaluate the presence of proteins in solid tumors which may lead to an immune response

Detailed description: The main objective of the study is to evaluate which proteins are presented by the HLA complex of solid tumors. Secondary objectives include to evaluate whether an immune response specific to these proteins has actually been provoked and whether there is a similar immune response following recurrence. Real specimens will be evaluated using PCR and mass spectrometry.

Eligibility: Inclusion Criteria:
  -  Patients with adenocarcinoma of breast, colon, rectum, ovary , stomach, pancreas
  Exclusion Criteria:
  -  Withdrawal of consent
  -  Small specimen which does not allow to retrieve tissue without interfering with pathologic evaluation

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

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