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

Clinical trial: Soy Isoflavones Supplementation in Treating Women at High Risk For or With Breast Cancer

Summary: RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of soy isoflavones supplements may prevent or treat early stage breast cancer. PURPOSE: This clinical trial studies soy isoflavones supplementation in treating women at high risk for or with breast cancer.

Detailed description: PRIMARY OBJECTIVES: I. To assess whether magnetic resonance imaging (MRI) volume (equivalent to 3-dimensional mammographic density) is reduced in high-risk women or those with invasive breast cancer or DCIS who are supplemented daily with soy (5p mg total isoflavones as aglycone) compared to placebo (microcrystalline cellulose) tablets for 1 year.II. To assess whether cell proliferation and apoptosis, as measured by Ki67 and caspase 3 staining, respectively, of breast epithelial cells is altered with soy treatment.SECONDARY OBJECTIVES: I. To assess whether other intermediate molecular markers including estrogen receptor alpha (ER alpha) and ER beta differ between women supplemented with soy vs placebo. OUTLINE: Patients are randomized to 1 of 2 treatment arms.ARM I: Patients receive oral soy isoflavones supplement once daily for12 months in the absence of disease progression.ARM II: Patients receive oral placebo once daily for 12 months in the absence of disease progression.

Eligibility: Inclusion Criteria:
  -  Women at high risk for breast cancer, defined as any of the following groups:
  -  Five year Gail risk > 1.7%
  -  Known BRCA1/BRCA2 mutation carrier
  -  Family history consistent with hereditary breast cancer
  -  Prior biopsy exhibiting atypical hyperplasia or lobular carcinoma in situ (LCIS)
  -  History of invasive breast cancer or ductal carcinoma in situ (DCIS) and have completed standard therapy including tamoxifen/aromatase inhibitor or will not be treated with tamoxifen/aromatase inhibitor
  -  Signed Informed Consent
  Exclusion Criteria:
  -  Metastatic breast cancer
  -  Undergoing treatment (chemotherapy, radiation, or SERMs)
  -  Pregnancy or breast-feeding, or planning to become pregnant within one year prior to study entry
  -  Regular soy consumers (i.e., < once per week of soy food, soy supplements or other products)
  -  Known food allergies such as to soy or nuts
  -  Not willing to avoid soy foods/supplements during study period
  -  Current users of exogenous hormones or oral contraceptive or planning to use exogenous hormones during the duration of the study
  -  Cannot stop taking aspirin or NSAIDs within a week of breast biopsy
  -  Active participant in other ongoing trials

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

Clinical trial: Covered or Uncovered Bile Duct Stents

Summary: The study is investigator initiated. Tumors that gives the narrowing of the bile ducts prevents bile from flowing from the liver to the intestine resulting in jaundice and the risk of bacterial growth in bile with severe infections as a result. Unresectable bile duct strictures have routinely been treated them with plastic stents. The plastic stents have been replaced by self expandable metallic stents.
  These stents remain open longer for reasons that they have a larger diameter so that the bile flows through more easily. One problem with these stents, however, is that the tumor growing through the wire mesh which forms the wall of the stent. This has led to the development of so-called covered stents. Whether covered stents have longer patency is unclear as well as whether they are as safe. There is reason to believe that covered stents remain open longer, but there may be an increased risk of migration and other complications.
  The purpose is to prospectively and randomized compare the two stent types. The study endpoint is the clogging of the stent or the patient's death. We also monitor complications, regress time of the jaundice and success rate of stent placement

Detailed description: 0

Eligibility: Inclusion Criteria:
  -  Patients with unresectable, distal bile duct stricture needing relieved endoscopically
  -  Expected survival greater than 3 months
  -  The patient must give written consent to participate in the study
  Exclusion Criteria:
  -  Stricture close to hilus
  -  Need for interpreter

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

Clinical trial: Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma

Summary: A phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic gemcitabine and capecitabine in combination with cetuximab in patient with non-resectable liver metastases from cholangiocarcinoma.


Eligibility: Inclusion Criteria:• Informed consent
  -  Age > 18 years
  -  Performance status 0-1; expected survival ≥ 3 months
  -  Patient with histologically or cytologically adenocarcinoma developed from cells in the gall bladder, extra- or intrahepatic bile ducts or malignant cells consistent with above mentioned and radiologic findings consistent with cholangiocarcinoma
  -  Liver metastases not suitable for surgery or other local treatment
  -  Extrahepatic disease should be excluded by PET-CT-scan.
  -  Prior treatment with chemotherapy or no progression on first line treatment
  -  Metastases < 70 % of the liver
  -  neutrophile granulocytes ≥ 1.5 x 109/l og thrombocytes ≥ 100 x 109/l
  -  bilirubin < 2.0 x UNL (upper normal limit).
  -  creatinine-clearance ≥ 30 ml/min.
  -  INR < 2.
  -  Intrahepatic treatment can be accomplished
  -  The patients is approved by a multidisciplinary team
  Exclusion Criteria:• Other current or prior malignant disease except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin.
  -  Cytotoxic or experimental treatment within a 14 days period before start of trial medication
  -  The patient is not allowed to participate in other clinical trials.
  -  Any clinical symptoms suggesting peripheral neuropathy grade 2
  -  Other severe medical conditions
  -  Severe cardial disease or AMI < 1 year
  -  Presence of diseases preventing oral therapy
  -  Patients with uncontrolled infection
  -  Pregnant or lactating women
  -  Women capable of childbearing not using a sufficient method of birth control
  -  Patients not able to understand the treatment or to collaborate
  -  Prior serious or unsuspected reaction after treatment with fluoropyrimidine
  -  Known prior hypersensitivity reactions to the agents
  -  Interstitial pneumonitis or pulmonary fibrosis

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

Clinical trial: Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B

Summary: The primary objective of this study is to evaluate the efficacy of tenofovir disoproxil fumarate (TDF) plus peginterferon α-2a (Peg-IFN) combination therapy for 48 weeks versus standard of care TDF monotherapy or Peg-IFN monotherapy for 48 weeks in non-cirrhotic adults with chronic hepatitis B virus (HBV) as determined by loss of hepatitis B surface antigen (HBsAg).
  The study will consist of 2 phases for participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups. Following an initial 48 weeks of treatment, participants in these groups will be monitored for 24 weeks for signs of worsening HBV, and those meeting TDF retreatment and flare management criteria will be eligible to receive TDF monotherapy during a retreatment phase, up to Week 120.


Eligibility: Inclusion Criteria:
  -  Adults (age 18-75) with chronic HBV (positive for serum hepatitis B surface antigen (HBsAg) or HBV DNA for at least 6 months) prior to baseline
  -  Anti-HBV treatment-naive adults; adults who have taken oral anti-HBV nucleoside therapy with the last dose ≥ 24 weeks prior to screening are also eligible.
  -  Positive or negative for hepatitis B e antigen (HBeAg)
  -  HBV DNA ≥ 20,000 IU/ml (HBeAg-positive participants) and ≥ 2,000 IU/ml (HBeAg-negative participants)
  -  Alanine aminotransferase (ALT) > 54 U/L and ≤ 400 U/L for men and > 36 U/L and ≤ 300 U/L for women
  -  Creatinine clearance ≥ 70 mL/min
  -  Negative serum pregnancy test for females of childbearing potential
  -  Sexually active females of childbearing potential must agree to use a protocol-recommended method of contraception throughout the study and for 30 days following the last dose of study medication
  -  Lactating females must agree to discontinue nursing before initiation of study investigational medicinal product
  Exclusion Criteria:
  -  Known bridging fibrosis or cirrhosis and/or decompensated liver disease
  -  Evidence of hepatocellular carcinoma
  -  Significant kidney, heart, lung, neurological, autoimmune disease, or bone disease (eg, osteomalacia,chronic osteomyelitis, osteogenesis imperfecta, osteochondrosis, multiple bone fractures)
  -  Absolute neutrophil count < 1,500/mm^3, platelet < 100,000/mm^3, hemoglobin < 10 g/dL (female) or < 11 g/dL (male)
  -  History of severe depression or severe psychiatric disease
  -  Thyroid dysfunction
  -  Coinfection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV)
  -  Pregnant

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

Clinical trial: Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors

Summary: This is a single-arm, open-label study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of talazoparib in patients with advanced tumors with DNA-repair pathway deficiencies. There will be 2 parts to the study: a dose escalation phase in which the maximum tolerated dose will be defined, and a dose expansion phase.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically documented, unresectable, locally advanced or metastatic solid tumor
  -  Must have available archived tumor tissue (formalin-fixed paraffin-embedded) [FFPE].
  -  18 years of age or older.
  -  Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) or increased CA-125 (ovarian cancer) or PSA (prostate cancer) and/or CA 19-9 (pancreatic cancer).
  -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  -  Have adequate organ function
  -  Able to take oral medications.
  -  Willing and able to provide informed consent.
  -  Sexually active patients must be willing to use an acceptable method of contraception.
  -  Females of childbearing potential must have a negative serum pregnancy test at screening.
  -  Willing and able to comply with all study procedures.
  Part 2 Dose Expansion Tumor Types:
  -  Breast and ovarian cancer patients with deleterious or pathogenic BRCA mutations who have received no more than 4 prior regimens for metastatic disease.
  -  Prostate or pancreatic cancer patients with deleterious or pathogenic BRCA mutations who have received no more than 2 prior regimens for metastatic disease.
  -  Small cell lung cancer (SCLC) patients who have received no more than one prior regimen for SCLC.
  -  Ewing's sarcoma patients who have received no more than 3 prior regimens for metastatic disease.
  Exclusion Criteria:
  -  Part 2 Expansion: Prior treatment with a PARP inhibitor.
  -  Has history of central nervous system (CNS) metastasis.
  * Exception: In patients with SCLC, history of adequately treated brain metastasis who do not require corticosteroids for management of CNS symptoms.
  -  Has had major surgery within 28 days before Cycle 1, Day 1.
  -  Has active peptic ulcer disease.
  -  Active gastrointestinal tract disease with malabsorption syndrome.
  -  Pregnant or breastfeeding at screening or planning to become pregnant (in each case, either oneself or one's partner) at any time during the study.

Relevance to patient case: possibly relevant
Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Search Allelic Imbalance of Expression of BRCA Genes in Hereditary Risk of Breast and/or Ovarian Cancer

Summary: The purpose of this study is to determine proportion of patients presented a search allelic imbalance of expression of genes BRCA 1 and 2 in population with hereditary breast and/or ovarian cancer risk and negative for deletion mutation BRCA 1 and 2 genes


Eligibility: Inclusion Criteria:
  For patients
  -  Women with breast cancer and / or ovarian cancer meet criteria suggestive of a hereditary predisposition
  -  Deleterious mutation of BRCA1 and BRCA2 sought and not highlighted
  -  Age ≥ 18 years
  -  Agreeing to participate in the study (a collection of signed informed consent)
  For control population
  -  Women with no history of breast and / or ovarian cancer and no family history of breast and / or ovarian cancer among family members on the 1st and 2nd degree before age 50 for breast cancer and before 60 years for ovarian cancer
  -  Agreeing to participate in the study (a collection of signed informed consent)
  Exclusion Criteria:
  For patients:
  -  Patients with a known deleterious mutation in BRCA1 and BRCA2
  -  Patients do not meet criteria suggestive of a hereditary predisposition
  -  Persons deprived of liberty or under guardianship (including guardianship)
  For control population:
  -  Males
  -  Personal or family history of breast and / or ovarian cancer (breast or ovarian cancer in their family experienced 1st and 2nd degree before age 50 for breast cancer before age 60 for cancer ovarian)
  -  Persons deprived of liberty or under guardianship (including guardianship)

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

Clinical trial: A Trial of Equine F (ab')2 Antivenom for Treatment of Scorpion Envenomation in Morocco

Summary: This study has the objective to demonstrate the effectiveness of Alacramyn NAMO in the treatment of North Africa and Middle East scorpions envenomation by reducing the severity of envenomation. The primary endpoint is make a comparison between antivenom and placebo groups, at 4 hours after study drug, of the number of cases showing improvement in class of envenomation.

Detailed description: In an effort to shorten hospital stay and to further decrease mortality, a new antivenom has been developed. This antivenom is a third generation F(ab')2 "fabotherapeutic" agent.It is administered intravenously which should lead to rapid neutralization of circulating venom. This study will demonstrate whether or not use of the new antivenom in children receiving standardized supportive care leads to resolution of the syndrome within 4 hours of treatment.The onset of clinical symptoms following a scorpion envenomation is usually within 5 to 30 minutes following the sting.
  Established a classification of the patient status to differentiate a simple scorpion sting from a severe envenomation. A simple sting (class I) is characterized by signs that are local only: pain at the inoculation point, redness, edema, and numbness.
  A class II envenomation is characterized by the presence of some systemic signs: hypothermia, hyperthermia, chills, nausea, abdominal pain and diarrhea. Being 15 years old or younger or the presence of priapism, vomiting, sweating, or a body temperature greater than 39°C are factors predictive of severity.
  A severe envenomation (class III) is characterized by cardiovascular failure, often leading to death; respiratory failure related to the cardiac failure; and neurologic failure due to hypoxia.

Eligibility: Inclusion Criteria:
  -  Male or female 6 months to 15 years
  -  Class II B or III scorpion envenomation
  -  Presenting within 5 hours of sting
  -  Informed consent read and signed by parent or legal guardian
  Exclusion Criteria:
  -  Unable to provide informed consent
  -  Prior use of antivenom for this envenomation
  -  Allergy to horse serum
  -  Pregnant or breast-feeding
  -  Patients with underlying condition mimicking symptoms of scorpion envenomation (congenital heart disease, chronic oxygen therapy, etcetera)

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

Clinical trial: Second-line Therapy of Unresectable Cholangiocarcinoma by RADIOEMBOLIZATION

Summary: Cholangiocarcinoma (CCK) is a rare tumor (2000 new cases/year in France) with very poor prognosis (overall survival < 3% at 5 years). Less than 20% of patients may benefit from curative surgical resection and most patients have medical treatment by palliative treatment by palliative chemotherapy. It is not standard first-line chemotherapy validated for unresectable CCK, but the best objective response rate (OR) and overall survival (OS) are observed with gemcitabine and platinum associations (OR 24 to 36% and OS between 9.5 to 15.4 months). In case of tumor progression ater this first line therapy, no treatment is currently being validated.
  RADIOEMBOLIZATION (RE) is a new, transarterial approach to radiation therapy using 90 Yttrium microspheres.
  In the patients with unresectable CCK , the first pilot studies showed interesting results with rates of OR 45 to 90% and a median OS of 14.9 mots and an acceptable safety.
  Study Hypothesis : RE could help achieve tumor stabilization in patients with intra-hepatic CCK in tumor progression after first-line therapy.

Detailed description: Extended description of the protocol, including information not already contained in other fields, such as comparison studied.
  It is a pilot study including 20 patients with unresectable intra-hepatic CCK in tumor progression after first-line therapy.
  Description of the protocol :
  1. Information and signed CONSENTMENT
  2. Preparatory phase : pre-treatment mesenteric angiography and technetium-99m macroaggregated albumin scans are performed to assess gastrointestinal flow and lung shunting.
  3. Therapeutic phase : intra-arterial administration of resin-based microspheres ( SIRSPHERES, SIRTEX). The RE can be performed in 2 sessions, especially if liver disease is bi-lobar.
  4. Follow up to J15,M1,M2,M4 and M6 : clinical examination and imaging evaluation ( scans and /or MRI)

Eligibility: Inclusion Criteria:
  -  Unresectable intra-hepatic CCK histologically proven
  -  Tumor progression documented on imaging evaluation ( CT or MRI) according to RECIST criteria version 1.1 after first-line therapy
  -  Performance status < 2 ; 4) Bilirubin < 36 micromol/l
  -  age > 18 years
  Exclusion Criteria:
  -  Extra-hepatic metastases
  -  Uncontrolled biliary obstruction
  -  Contra-indications to RE.

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

Clinical trial: Phase 1 Study of Pazopanib With GSK1120212 in Advanced Solid Tumors, Enriched With Patients With Differentiated Thyroid Cancer, Soft-tissue Sarcoma, and Cholangiocarcinoma

Summary: The purpose of this study is to determine the safety and toxicity of the combination of pazopanib and GSK1120212 in patients with solid tumors and identify the maximum tolerated dose (MTD) of this combination for phase II study.


Eligibility: Inclusion Criteria:
  -  Dose escalation cohort for all solid tumors is closed to enrollment.
  -  Expansion cohorts: Soft-tissue sarcoma, cholangiocarcinoma, and differentiated thyroid cancer (DTC) cohorts are closed to enrollment. Patients in the DTC cohort must have disease that is able to be biopsied.
  -  Must have measurable disease.
  -  Tumor progression in the 6-month period prior to study drug initiation.
  -  DTC patients: must have radioiodine non-avid lesions, OR radioiodine avid lesions that have not responded to treatment with radioactive iodine.
  -  ECOG performance status less than or equal to 1.
  -  Life expectancy >3 months.
  -  Blood pressure <140 mmHg and <90 mmHg.
  -  LVEF is >= 50%
  -  Must be able to swallow pills.
  Exclusion Criteria:
  -  Chemotherapy, radiotherapy, other investigational therapy, or major surgery within 4 weeks.
  -  Sarcoma and cholangiocarcinoma ONLY: Prior VEGF-targeted TKI therapy.
  -  Pregnant or currently breastfeeding.
  -  Unresolved toxicity greater than grade 1.
  -  Evidence of active hepatitis or HIV.
  -  Significant cardiovascular disease.
  -  Taking medications known to be strong inducers or inhibitors of CYP3A enzymes.
  -  Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding.
  -  History of gastrointestinal condition causing malabsorption or obstruction.
  -  Cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep vein thrombosis (DVT) within past 6 months.
  -  Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase risk of pulmonary hemorrhage.
  -  Hemoptysis within 6 months of starting treatment.
  -  History of retinal vein occlusion (RVO) or central serous retinopathy (CSR), or predisposing factors to RVO or CSR as assessed by ophthalmic exam.
  -  Known brain mets that are not stable for at least 8 weeks prior to treatment, or patient is on glucocorticoids for brain mets.

Relevance to patient case: not relevant