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

Clinical trial: Study of Genes and the Environment in Patients With Ovarian Cancer in the East Anglia, Oxford, Trent, or West Midlands Regions of the United Kingdom

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This study is looking at genetic susceptibility for cancer and interactions between genes and the environment in patients with ovarian cancer.

Detailed description: OBJECTIVES:
  -  To obtain epidemiological information and biological material on a population-based series of ovarian cases.
  -  To define the proportion of ovarian cancer incidence attributable to mutations in known predisposing genes (e.g., BRCA1 and BRCA2).
  -  To determine the risk associated with predisposing mutations by examining the cancer risks in relatives of patients who are shown to be carriers.
  -  To examine the effect of nongenetic risk factors in mutation carriers.
  -  To determine the pathological and clinical characteristics of ovarian cancers occurring in BRCA1/2 mutation carriers as compared with that in noncarriers.
  -  To establish whether mutations at other loci may predispose to ovarian cancer by comparing the frequency of alterations in ovarian cancer patients with that in cancer-free controls identified through the European Prospective Investigation of Cancer (EPIC) study.
  OUTLINE: This is a multicenter study.
  Patients complete an epidemiological questionnaire. The questionnaire will request identifying information on the patient's first-degree relatives.
  Blood samples are collected from patients. DNA is extracted from these blood samples and from samples collected from cancer-free control participants in MREC-SEARCH-CONTROL as well as from additional controls through the European Prospective Investigation of Cancer (EPIC) study (a population based study of diet and health based in Norfolk, East Anglia). DNA samples are analyzed for polymorphisms of low penetrance cancer susceptibility genes.
  In addition to the ovarian cancer patients recruited for this study, patients with breast, endometrial, prostate, colorectal, bladder, kidney, pancreatic, brain and esophageal cancer, malignant melanoma, and lymphoma cancer are recruited in the following related clinical trials: MREC-SEARCH-BREAST, MREC-SEARCH-ENDOMETRIAL, MREC-SEARCH-PROSTATE, MREC-SEARCH-COLORECTAL, and MREC-SEARCH-CANCER.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of ovarian cancer within the past 5 years
  -  Identified through the East Anglia, Stoke and West Midlands Cancer Registries serving any of the following geographic regions of the United Kingdom:
  -  East Anglia
  -  Oxford
  -  Trent
  -  West Midlands
  PATIENT CHARACTERISTICS:
  -  Identified by the patient's general practitioner as fit to contact for this study
  -  No serious mental illness or retardation
  PRIOR CONCURRENT THERAPY:
  -  Not specified

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

Clinical trial: Do Aromatase Inhibitors (AIs) Decrease Intestinal Calcium Absorption?

Summary: Research Question: Do Aromatase Inhibitors Decrease Intestinal Calcium Absorption?
  Study Design: Postmenopausal women with early stage breast cancer initiating aromatase inhibitor adjuvant therapy will participate in this two-month study. The primary study outcome is the change in intestinal calcium absorption following such therapy. Secondary outcomes are the changes in bone resorption markers and musculoskeletal signs and symptoms after initiation of therapy.
  We will interview women and review their medical records to determine eligibility. Eligible subjects will undergo two calcium absorption studies. The first study will determine their baseline calcium absorption, and the second study will occur after taking an aromatase inhibitor daily for at least 6 weeks. Women will present to the research unit in the early morning and receive an oral and intravenous stable calcium tracer with breakfast. Over the next 24 hours, we will collect all urine for measurement of its calcium content. During each inpatient stay, we will assess musculoskeletal symptoms by questionnaire and joint examination. Each woman will complete a four-day diet diary twice during the study.


Eligibility: Inclusion Criteria:
  -  Women at least 5 years past menopause, defined as date of last menses or bilateral oophorectomy
  -  Newly diagnosed breast cancer and starting an AI as initial adjuvant therapy
  Exclusion Criteria
  -  Recent, current or planned chemotherapy for breast cancer, as this may have independent effects on intestinal health, calcium homeostasis and bone turnover
  -  Allergy or intolerance to orange juice, as one isotope is given with orange juice
  -  Current use of over-the-counter or prescription antacids, as they may influence Ca-Ab
  -  Intestinal conditions associated with malabsorption or low gastric acid levels including Crohn's disease, ulcerative colitis, pernicious anemia, bacterial overgrowth, celiac sprue, chronic diarrhea or use of antibiotics within the past month
  -  Known Stage 4 or 5 Chronic Kidney Disease, defined as an estimated GFR <30 cc/minute
  -  Use of medications known to interfere with calcium or vitamin D metabolism, including oral steroids or anticonvulsants
  -  Significant lymphedema precluding adequate intravenous access

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

Clinical trial: Preoperative Biliary Drainage for Resectable Hilar Cholangiocarcinoma

Summary: This study is to investigate whether preoperative biliary drainage can reduce the postoperative morbidity in patients with hilar cholangiocarcinoma.

Detailed description: Preoperative biliary drainage(PBD) or not, is a Hot Spot issue in the management of Hilar cholangiocarcinoma. Surgeons from Japan tend to perform PTBD(Percutaneous Transhepatic Biliary Drainage) before a definite operation until the total bilirubin(TB) lower than 85μmol/L. For some patients needed to perform extended curative resection, PVE(Portal Vein Embolization) is performed and thus the duration of PBD may be around six weeks and the final TB is lower than 34μmol/L. Some tend to perform a definite curative operation in a short time after diagnosis. There is no RCT research on the effect of PBD for the resectable Hilar Cholangiocarcinoma patients to date.

Eligibility: Inclusion Criteria:
  -  Patients newly diagnosed
  -  Resectable patients after imaging assessment and evaluation of general condition of the patient
  -  TB>85μmol/L
  -  WBC account more than 1.5×109/L, PLT account more than 100×109/L and HB account more than 100g/L
  -  No serious disease in heart, lung and kidney
  -  Written informed consent
  Exclusion Criteria:
  -  Unresectable patients.
  -  Patients have received biliary drainage procedure such as PTBD before admission
  -  Complicated with chronic hepatitis
  -  Myocardia infarction record within six months
  -  Women in pregnancy
  -  Serious disease in heart, lung or kidney

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

Clinical trial: Thymidine Kinase 1 in Risk Assessment for Hereditary Breast /Ovarian Cancer

Summary: This study aimed to compare the activity of Thymidine Kinase 1 in serum of two groups of woman at high and normal risk for breast/ovary cancer.

Detailed description: Hereditary breast/ovarian cancer syndrome is associated with mutations in tumor suppressor BRCA1 and BRCA2 genes. Products of these genes play an important role in the repair of DNA double-strand breaks. Mutations in BRCA1 and BRCA2 genes could impair DNA repair. In resting or G1 cells, where the de novo synthesis of DNA precursors is absent, the salvage pathway is the sole provider of deoxyribonucleotides to be used in DNA repair. For this process a sufficient supply of deoxynucleotides and activity of Thymidine Kinase 1 are essential. TK1 is an important component of adaptive response of cells to DNA damage. Mutations in genes directly engaged in the DNA repair process could lead to the accumulation of DNA damage and in turn cause an adaptive cell reaction manifesting as permanently increased Thymidine Kinase 1 activity.
  A recently developed new high-sensitive assay DiviTum® allows to investigate the contribution of this enzyme to DNA repair processes and to make a comparison of Thymidine kinase 1 activity in women with normal and impared DNA repair system.

Eligibility: Inclusion Criteria:
  -  women from family with more than two breast cancer cases and one or more cases of ovarian cancer diagnosed at any age;
  -  women from family with more than three breast cancer cases diagnosed before the age 50;
  -  women from family withsister pair in which one of the following combinations was diagnosed before the age of 50: two breast cancers, two ovarian cancers, or a breast and ovarian cancer.
  Exclusion Criteria:•
  -  pregnant women;
  -  women with generalized CMV and HZV infections;
  -  women with severe B12 deficiency and megaloblastic anaemia;
  -  women with severe rheumatoid arthritis.

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

Clinical trial: S-1 and Photodynamic Therapy in Cholangiocarcinoma

Summary: In patients with unresectable perihilar cholangiocarcinoma, photodynamic therapy with biliary stent has been known for palliation of jaundice and improving survival. But most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic agent, S-1 was reported as effective in patients with bile duct adenocarcinoma. The investigators' aims of study evaluate the combined effect of photodynamic therapy and S-1.

Detailed description: In patients with unresectable perihilar cholangiocarcinoma, photodynamic therapy with biliary stent has been known for palliation of jaundice and improving survival. But most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic agent, S-1 was reported as effective in patients with bile duct adenocarcinoma. The investigators' aims of study evaluate the combined effect of photodynamic therapy and S-1.

Eligibility: Inclusion Criteria:
  -  Histologic or cytologic diagnosis of cholangiocarcinoma
  -  Not eligible for curative surgery
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better
  -  No serious or uncontrolled concomitant medical illness
  -  Adequate bone marrow function (absolute neutrophil count ≧1,500 ul, platelet count ≧75,000/ul)
  -  Consent this study in letter
  Exclusion Criteria:
  -  Another neoplasia
  -  Porphyria
  -  Pregnant or breastfeeding women

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

Clinical trial: Studying Breast Cancer Risk in Women Who Are BRCA1/BRCA2 Mutation Carriers

Summary: RATIONALE: Studying samples of DNA in the laboratory from women who are BRCA1/BRCA2 mutation carriers may help doctors learn more about cancer and identify biomarkers related to cancer.
  PURPOSE: This research study is looking at breast cancer risk in women who are BRCA1/BRCA2 mutation carriers.

Detailed description: OBJECTIVES:
  -  To identify potential genetic modifiers of breast cancer risk by contributing data and genetic information obtained from women who are BRCA1/BRCA2 mutation carriers enrolled in clinical trial GOG-0199 to an international consortium of clinical cancer genetics investigators (CIMBA).
  OUTLINE: This is a multicenter study. Patients are stratified by study, country of residence, ethnicity, and birth cohort. Joint analyses of BRCA1 and BRCA2 mutation carriers are further stratified by mutation.
  Previously collected DNA samples are analyzed for genetic variants in selected candidate genes (rs16942 in BRCA1, rs2237060 in RAD50, "SNP3", and rs2241193 in IGFBP5). The single nucleotide polymorphism (SNP) data from this study and selected demographic, clinical, and epidemiological data obtained from the baseline questionnaire administered in the GOG-0199 study are submitted to the Consortium of Investigators of Modifiers of BRCA-Associated Cancer (CIMBA) Central Database. The epidemiological and SNP data contributed to the Central Database are then distributed to the investigators responsible for analysis of a particular SNP or set of SNPs from a candidate gene or genetic pathway.

Eligibility: DISEASE CHARACTERISTICS:
  -  Known positive BRCA1/BRCA2 mutation carrier
  -  With or without a personal history of breast cancer prior to enrollment in clinical trial GOG-0199
  -  Currently enrolled in clinical trial GOG-0199 AND meets the following criteria:
  -  Completed baseline questionnaire (BQ-199)
  -  Provided information on prior breast cancer history, including date of diagnosis
  -  Provided complete data from the DNA analysis on the genetic variants of interest
  -  Signed an approved informed consent and authorization permitting release of personal health information
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  PRIOR CONCURRENT THERAPY:
  -  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: Breast Cancer Risk in Women Who Are BRCA1/BRCA2 Mutation Carriers

Summary: This research study is looking at breast cancer risk in women who are BRCA1/BRCA2 mutation carriers. Studying samples of DNA in the laboratory from women who are BRCA1/BRCA2 mutation carriers may help doctors identify biomarkers related to cancer.

Detailed description: OBJECTIVE:
  I. To identify potential genetic modifiers of breast cancer risk in women who are carriers of the breast cancer susceptibility genes, BRCA1/2, by collecting data and genetic information from GOG-0199 and contributing it to the Consortium of Investigators of Modifiers of BRCA-Associated Breast Cancer (CIMBA), an international consortium of clinical cancer genetics investigators.
  OUTLINE: This is a multicenter study. Patients are stratified by study, country of residence, ethnicity, and birth cohort. Joint analyses of BRCA1 and BRCA2 mutation carriers are further stratified by mutation.
  Previously collected DNA samples and associated clinical information obtained from BRCA mutation-positive participants enrolled on GOG-0199 are studied. DNA samples are analyzed by mutation testing for variants (i.e., single nucleotide polymorphisms [SNPs]) in candidate genes of interest. Once genetic testing for a given set of variants has been completed, the coded laboratory data file is merged with selected demographic, clinical, and epidemiological data obtained from the GOG-0199 baseline questionnaire and submitted to the Consortium of Investigators of Modifiers of BRCA-Associated Breast Cancer (CIMBA) Central Database to analyze and publish the data. The epidemiological and SNP data contributed to the central database are then distributed to the investigators responsible for analysis of a particular SNP or set of SNPs from a candidate gene or genetic pathway.

Eligibility: Inclusion Criteria:
  -  Women with or without a personal history of breast cancer prior to enrollment in Gynecologic Oncology Group (GOG)-0199
  -  Known currently to be BRCA1/2 mutation carrier either by confirmed outside report or by research testing
  -  No BRCA1/2 mutation-negative or mutation-unknown status
  -  Enrolled on clinical trial GOG-0199 AND meets the following criteria:
  -  Completed baseline questionnaire (BQ-199)
  -  Provided information on previous breast cancer history, including date of diagnosis
  -  Provided complete data from the DNA analysis on the genetic variants of interest
  -  Available DNA samples for analysis
  -  Hormone receptor status not specified
  -  Pre- or post-menopausal status

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

Clinical trial: Photodynamic Therapy (PDT) Trial for Palliation of Cholangiocarcinoma

Summary: This research study is a phase III double arm, multicenter, randomized controlled clinical trial comparing endoscopic retrograde cholangiopancreatography (ERCP) and stenting plus photodynamic therapy (PDT) versus ERCP with stenting alone in adult patients with unresectable cholangiocarcinoma.
  The study objectives are to investigate the efficacy of photodynamic therapy (PDT) in increasing the survival time of patients with unresectable cholangiocarcinoma and to assess the effect of PDT on both cholestasis and health-related quality of life (HRQoL).

Detailed description: The study objectives are to investigate the efficacy of photodynamic therapy (PDT) in increasing the survival time of patients with unresectable cholangiocarcinoma and to assess the effect of PDT on both cholestasis and health-related quality of life (HRQoL).

Eligibility: Inclusion Criteria:
  -  Patient is age 18 years or older
  -  Patient is diagnosed with non-resectable cholangiocarcinoma, as determined by CT within 30 days of enrollment and CT shows Bismuth Tumor Stage as: IIIa, IIIb, IV (Bismuth tumor stage I and II are not eligible to participate)
  -  Patients must have adequate organ and marrow function as defined below:
  -  Patient's INR ≤ 2 within 30 days of treatment
  -  Patient's platelets > 50,000/cmm within 30 days of treatment
  -  Patient's Absolute Neutrophil Count (ANC) > 1,500/cmm within 30 days of treatment
  -  Patient's creatinine ≤ 3 mg/dL within 30 days of treatment
  -  Patient has the ability to understand and the willingness to comply with the study procedures and provide written informed consent to participate in the study
  Exclusion Criteria:
  -  Patient was diagnosed with cholangiocarcinoma more than 3 months ago
  -  Patient has any metastatic disease
  -  Patient has acute porphyria
  -  Subjects exhibiting neurologic or cutaneous symptoms will undergo urinary delta-aminolevulinic acid and porphobilinogen dosage tests to determine severity.
  -  Patient is pregnant (Women of child bearing age must have a negative pregnancy test prior to registration and must agree to use adequate contraception during study therapy)
  -  Patient has a concurrent non solid malignancy

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

Clinical trial: Autologous Cell Therapy After Stroke

Summary: This study will examine the safety of two different cellular therapies in the treatment of stroke.

Detailed description: Stroke remains a leading cause of death and disability. A limited number of therapies, such as intravenous tissue plasminogen activator, have been approved to interrupt stroke in the early hours after symptom onset. Many patients are not able to benefit from these therapies, however, and so a need exists for development of new interventions to reduce disability after stroke. This study will be an early step towards this, and will examine the safety of two cell types, mononuclear cells and marrow stromal cells. In each case, the cells will be autologous, specifically being derived from the subject's own bone marrow.

Eligibility: Inclusion Criteria:
  -  Ischemic stroke that is supratentorial in location and < 72 hours old between stroke onset and bone marrow aspiration
  -  No major pre-stroke disability
  -  NIH stroke scale score of 7-24
  -  Able to undergo bedside bone marrow aspiration
  -  Age 18-85 years, inclusive
  -  Reasonable likelihood of receiving standard physical, occupational and speech rehabilitation therapy
  Exclusion Criteria:
  -  No major active hematological, immunological, or oncological diagnoses
  -  Pregnancy
  -  Lactating mothers
  -  At least 24 hours time of any thrombolytic therapy and time of bone marrow aspiration
  -  Allergy to penicillin or to fetal bovine serum
  -  Active, major co-existent neurological or psychiatric disease
  -  Infection with HIV, hepatitis B or C, or syphilis
  -  Any diagnosis that makes survival to 90 days post-stroke unlikely
  -  Participation in an experimental therapeutic clinical trial in the prior three months

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

Clinical trial: Study of Post Operative Pain in Endometrial Cancer Robotic Versus Laparotomy

Summary: This study is being done to evaluate the efficacy of robotic approach for staging of endometrial cancer as compared to an equivalent abdominal approach. The primary objective is to measure and compare postoperative pain at rest at several time points between two groups of patients undergoing either robotic or open laparotomy approach for staging of endometrial cancer.

Detailed description: The primary objective is to measure and compare postoperative pain at rest at several time points (24 +/-4hours, 48 +/-4hours, and 72 +/-4hours) between the two groups of patients undergoing either robotic or open laparotomy approach for staging of endometrial cancer. Post operative Quality of Life will also be collected at several time points. The total amount of post operative opioid requirements during the first 24hours between patients undergoing either robotic or open laparotomy approach surgery. The survival status every four months for the first two years will be monitored, then every 6 months for up to 5 years. The primary endpoint is the mean difference in post operative pain VAS scores reported by subjects at rest at the following time points: 24+/-4, 48+/-4, and 72+/-4 hours between both groups after surgery has been completed.

Eligibility: Inclusion Criteria:
  -  Female subjects between ages 18-86 years old
  -  Subject provided written consent
  -  Preoperative diagnosis of stage i or II endometrial cancer
  -  Subject scheduled to undergo robotic hysterectomy or open abdominal hysterectomy at The Ohio State University
  -  Subject should be expected to be able to use and tolerate opioids for pain management
  -  Pre operative health is graded as ASA I-III
  -  ECOG(Eastern Cooperative Oncology Group)Performance status 0-3
  -  Subject willing to comply with scheduled visits
  Exclusion Criteria:
  -  Subject is prisoner, pregnant, or under age 18 or over age 85
  -  Hypersensitivity to opioids
  -  subject is breastfeeding
  -  Preoperative Health grade ASA IV-V
  -  ECOG Performance Status 4-5
  -  History of receiving prior chemotherapy or radiation therapy
  -  Subject schedule for additional procedures at the same time as the surgical staging
  -  Subject with pain related illness that to the PI discretion would interfere with study assessments.
  -  Known history of alcohol, analgesic, or narcotic abuse within 12 months.
  -  Subjects taking NSAID(nonsteroidal anti inflammatory drug medications)within 7 days prior to baseline visit.
  -  Require and/or receive chronic analgesic therapy for any pain related condition
  -  Severe acute or chronic medical or psychiatric condition that would interfere with the study results.

Relevance to patient case: not relevant