araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Step by Step: A Tailored Walking Intervention for Breast Cancer Survivors

Summary: This study aims to recruit post-treatment breast cancer survivors for a 12-week 2-arm randomized walking intervention. All intervention materials will be delivered electronically.
  The investigators hypothesize that at the end of 12-weeks, participants randomized to the intervention group will engage in more weekly steps than those participants randomized to the comparison group.

Detailed description: More than two-thirds of breast cancer survivors are physically inactive. Inactivity is known to negatively impact both morbidity and mortality, and is especially pronounced among cancer survivors. Self-directed interventions targeting inactivity among breast cancer survivors often report clinically insignificant behavior change. More successful behavior change interventions have suggested that tailoring and, more recently, the fostering of intrinsic motivation, may have improved outcomes. However, no interventions to date have utilized these approaches to increase physical activity among sedentary cancer survivors.
  AIM 1: Develop and test intervention (tailored) and comparison group (targeted) messages in a sample of sedentary women to determine message acceptability.
  AIM 2: Determine the efficacy of a 12-week tailored intervention to increase the number of weekly steps taken among sedentary post-treatment breast cancer survivors compared to a 12-week, targeted intervention.

Eligibility: Inclusion Criteria:
  -  Female
  -  40-70 years of age
  -  History of breast cancer stage I-II
  -  2-10 years post-treatment
  -  Sedentary
  -  Technology access and skills
  -  Regular access to personal computer/ broadband internet and email account
  -  Comfortability using internet, and web-based tools
  -  US Resident
  Exclusion Criteria:
  -  Concurrent enrollment in another physical activity/ lifestyle/ weight loss intervention program/study
  -  Current secondary cancer diagnosis/ treatment
  -  Inability to ambulate
  -  Refusal to wear personal activity monitor (FitBit Ultra) for the duration of the study
  -  Engaging in regular moderate to vigorous physical activity

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Breast Cancer Molecular Analysis Protocol

Summary: This is a molecular testing study for patients with metastatic breast cancer. The purpose of this study is to find defects in the DNA of the cancer that could potentially be treated with US Food and Drug Administration (FDA)approved or investigational drugs. For example, if your cancer has a mutation in the Epidermal Growth Factor Receptor (EGFR) gene (a mutation is a change int he DNA sequence of a gene) that makes this receptor "superactive" a drug that inhibits this receptor may also inhibit the growth of the cancer. If this genetic defect is not present in the cancer the same drug may not work. This EGFR gene mutation based patient selection for treatment has worked in lung cancer and we are testing its value in breast cancer. What drugs may be available against particular genetic abnormalities in the context of this clinical study will change over time.


Eligibility: Inclusion Criteria:
  1. All patients with metastatic breast cancer who are considered for further systemic therapy are eligible regardless of number of prior therapies.
  2. Patient must have a metastatic lesion that could be safely biopsied with or without image-guidance. The final arbiter to decide what lesion can be biopsied is the physician who will perform the biopsy.
  3. There is no age limit for this study. However, this study will not include children because metastatic breast cancer does not occur in children.
  4. Patients may participate in the biopsy study multiple times to repeat molecular assessment of the cancer after progression.
  5. Patients who undergo routine clinical biopsy of metastatic breast cancer are also eligible to participate in this study. When the routine biopsies are obtained for diagnostic or other purposes, additional biopsies will be taken during the same biopsy session for molecular analysis.
  Exclusion Criteria:
  1. Known medical contraindication for needle biopsy procedure such as bleeding disorder, low platelet count, inability to provide informed consent

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Direct Peritoneal Resuscitation Plus Conventional Resuscitation

Summary: The purpose of this study is to find out if direct peritoneal resuscitation (DPR) (putting a sugar solution into the abdominal cavity) helps blood flow through vital organs in the body that may suffer from low blood flow due to surgery. We will also try to find out if the DPR will help patients recover faster from liver surgery. Lastly, this study will also try to find if direct peritoneal resuscitation decreases levels of signaling chemicals in the blood called 'cytokines' and a protein called high-mobility group protein 1, which is known to cause tissue damage.

Detailed description: Our study will focus on 108 patients requiring hepatic resection for colorectal cancer metastasis or primary hepatocellular carcinoma. These patients will then be randomized into two 54 patient arms: the control arm of conventional resuscitation only and the experimental arm of conventional resuscitation with DPR immediately post operatively. Patient exclusion criteria will be: 1) unable to obtain proper consent for enrollment, 2) age less than 18 years or greater than 75 years, 3) chronic renal failure, cirrhosis, or congestive heart failure, 4) patients requiring portal venous embolization prior to resection, or 5) women who are pregnant or lactating/breast feeding. A pregnancy test (urine or blood) will be done for female subjects of child bearing potential the day prior or the morning of surgery per the usual standard of care pre-op labs.

Eligibility: Inclusion Criteria:
  -  Colorectal cancer
  -  Scheduled for liver resection
  -  18 to 75
  Exclusion Criteria:
  -  Chronic renal failure
  -  Cirrhosis
  -  Congestive heart failure
  -  Requiring portal venous embolization prior to resection
  -  Pregnant or nursing

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Real World Efficiency of Trastuzumab in Early Breast Cancer

Summary: AIM To determine the value of trastuzumab in the early breast cancer setting in the Netherlands.
  RESEARCH QUESTIONS / OBJECTIVES
  1. Is adjuvant trastuzumab in daily practice effectively used, that is, how and to whom is it given?
  2. Is the introduction of trastuzumab in early breast cancer cost-effective for the Netherlands?
  To address the research questions (objectives), the following outcome measures will be determined:
  CLINICAL OUTCOME MEASURES
  1. Actual trastuzumab administration as opposed to planned trastuzumab administration
  2. Selection criteria for chemotherapy and trastuzumab in daily practice
  3. Immediate and longterm toxicities due to adjuvant treatment, specifically cardiac
  4. Disease-free, breast cancer specific, and overall survival in relation to trastuzumab
  ECONOMIC OUTCOME MEASURES
  5. Volumes and costs of diagnostic tests and therapies including those for (distant) relapse
  6. Cost-effectiveness of trastuzumab in clinical trials versus in real world


Eligibility: Inclusion Criteria:
  -  All patients diagnosed with invasive stage I-III breast cancer in the years 2005, 2006 and 2007 in the participating 5 hospitals.
  Exclusion Criteria:
  -  Distant metastasis at the time of the primary diagnosis

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: A Study of GDC-0068 in Combination With Fluoropyrimidine Plus Oxaliplatin in Participants With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

Summary: This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy of GDC-0068 in combination with oxaliplatin, 5-fluorouracil, and leucovorin (modified FOLFOX6 [mFOLFOX6]) chemotherapy in participants with advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer. Participants will be randomized to receive either GDC-0068 or placebo orally daily on Days 1 to 7 of each 14-day cycle in combination with mFOLFOX6 on Day 1 of each cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs (up to approximately 2 years).


Eligibility: Inclusion Criteria:
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  -  Histologically documented, inoperable locally advanced or metastatic or recurrent gastric/GEJ adenocarcinoma, not amenable to curative therapy
  -  Measurable disease, according to RECIST v1.1
  -  Life expectancy greater than or equal to (>/=) 12 weeks
  -  Adequate hematologic and organ function
  Exclusion Criteria:
  -  Previous chemotherapy for inoperable locally advanced or metastatic gastric/GEJ adenocarcinoma. Participants may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced gastric/GEJ adenocarcinoma, provided all treatments were completed >/= 6 months prior to randomization.
  -  Known human epidermal growth factor receptor 2 (HER2)-positive gastric/GEJ adenocarcinoma
  -  Radiation treatment within 28 days of randomization. Participants who have received palliative radiation treatment to peripheral sites (eg, bone metastases) within 28 days of randomization may be enrolled in the study if they have recovered from all acute, reversible effects and with notification of the Medical Monitor.
  -  Previous therapy for gastric/GEJ adenocarcinoma with Akt, phosphatidylinositol 3-kinase (PI3K), and/or mammalian target of rapamycin (mTOR) inhibitors
  -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: BRCA1/2 and Effect of Mifepristone on the Breast

Summary: Ovarian steroids, as well as their synthetic counterparts gestagens and estrogens have a role in breast cell proliferation and the development of breast cancer. Here, the effect of a progesterone receptor modulator, mifepristone, on cell proliferation in human breast tissue in vivo will be studied in women with BRCA-1 or -2 mutations. Our preliminary results implicate a possible protective effect of mifepristone in breast epithelium. The ability of mifepristone to block breast epithelial cell proliferation may prevent tumorigenesis and may also prove beneficial when used for contraceptive purposes and on other indications. The proposed project concerns a Randomized Controlled Trial on mifepristone versus placebo treatment of women with BRCA-1or -2 mutations with a high risk/incidence of breast cancer and ovarian cancer.

Detailed description: Objectives • Research objective To study the safety and effect of treatment with mifepristone, a progesterone receptor modulator, on epithelial cell proliferation in human breast tissue in women with BRCA-1 or -2 mutations prior to protective mastectomy.
  Project description
  • Hypothesis/ Theory Mifepristone treatment exerts an antiproliferative, protective effect on breast tissue in women with BRCA-1 or -2 mutations
  Study Design Randomized, double blind, placebo controlled trial. Women will be recruited among patients with BRCA-1 or -2 mutations scheduled for prophylactic mastectomy. Included women will be randomized to a 3-month treatment with mifepristone, 50 mg (Mifegyne, Exelgyn, Paris, France) or placebo taken orally every second day. Breast biopsies will be obtained in the luteal phase prior to start of treatment and again during surgery.

Eligibility: Inclusion criteria:
  -  Pre-menopausal women, >/= 18 years of age
  -  with good general health and
  -  regular menstrual cycles (25-35 days) who are willing and
  -  able to participate after giving informed consent.
  -  women having BRCA1/2 mutation and have decided to undergo risk reducing mastectomy
  Exclusion criteria includes:
  -  Any hormonal treatment used within 2 months prior to study start and
  -  Any contraindication to mifepristone

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Gene Expression Profiling of Malignant Tumor Predict the Therapeutic Response of DC-CIK Immunotherapy

Summary: To investigate gene expression profile and immunological associated analysis relating to immunotherapy response of patients with malignant tumor after DC-CIK immunotherapy.

Detailed description: 1. The patients with malignant tumor are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) .
  2. Venous blood (4 ml) is collected from each subject and placed into tubes containing Ethylene Diamine Tetraacetic Acid(EDTA) before and after each treatment. Lymphocytes are sorted by Fluorescence Activated Cell Sorting(FACS) and stored at -80°C until processing.
  3. The T-Cell Receptor/B-Cell Receptor gene expression is detected by micro-array。
  4. Estimate Immunotherapy response, time to disease progression, survival rates and clinical benefit response on patients. Response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines. Degree of response is used to divide the cancers into two groups: sensitive and non-sensitive to immunotherapy.
  5. Compare the gene expression profile between different immunotherapy response groups to explore the mechanism that predict the DC-CIK immunotherapy response.

Eligibility: Inclusion Criteria:
  -  histologically confirmed with malignant tumor;
  -  Age: 18-80 years;
  -  an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  -  At least one measurable lesion according to the RECIST criteria;
  -  Adequate bone marrow, cardiac, liver, and renal function;
  -  Life expectancy ≥2 months;
  -  Not received other anti-tumor treatment
  -  Informed consent signed
  Exclusion Criteria:
  -  previous history of other malignancies;
  -  Uncontrolled central nervous system metastases;
  -  Serious or uncontrolled concurrent medical illness.

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: A Trail of Neoadjuvant Endostar in Combination With Chemotherapy in Breast Cancer

Summary: The trial was designed to study the efficacy and safety of neoadjuvant docetaxel, epirubicin in combination with cyclophosphamide(DEC) plus human recombinant endostatin (endostar) for breast cancer patients. The hypothesis of this protocol is that the combined an active angiogenesis agent to chemotherapy could enhance the pathological responce rate and further benefit breast cancer patients.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis)
  -  Age 18-70
  -  No evidence of distant metastasis
  -  No previous therapy
  -  Normal hematologic function
  -  No abnormality of renal or liver function
  -  Written informed consent
  Exclusion Criteria:
  -  With allergic constitution or possible allergic reflection to drugs to be used in this study
  -  Any concurrent uncontrolled medical or psychiatric disorder
  -  History of severe heart diseases, including congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction, uncontrolled high blood pressure, or heart valve disease
  -  Being pregnant or nursing

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents

Summary: This study will evaluate PF-05212384 (PI3K/mTOR inhibitor) in combination with either docetaxel, cisplatin or dacomitinib in select advanced solid tumors. The study will assess the safety, pharmacokinetics and pharmacodynamics of these combinations in patients with advanced cancer in order to determine the maximum tolerated dose in each combination.


Eligibility: Inclusion Criteria:
  -  Arm A: castrate resistant prostate cancer, advanced breast cancer, or non-small cell lunch cancer that are candidates for treatment with a docetaxel-based combination.
  -  Arm B: Urothelial transitional cell cancer, triple negative breast cancer, ovarian cancer or non small cell lunch cancer that are candidates for a cisplatin-based combination.
  -  Arm C: Her2+ breast cancer refractory to prior herceptin or lapatinib, her2+ esophagal-gastric cancer, head and neck squamous cell cancer, or non small cell lunch cancer that are candidates for treatment with a dacomitinib-based combination.
  -  Availability of archival tumor biopsy sample or willing to provide fresh biopsy if not available.
  -  Eastern Cooperative Oncology Group [ECOG] performance must be 0 or 1.
  -  Adequate bone marrow, renal and liver function.
  Exclusion Criteria:
  -  Patients with known symptomatic brain metastases.
  -  Chemotherapy, radiotherapy, biologics or investigational agent within 4 weeks of the lead-in dose.
  -  Major surgery within 4 weeks of the baseline disease assessments.
  -  >2 prior regimens containing cytotoxic chemotherapy in the metastatic setting.
  -  Active bacterial, fungal or viral infection.
  -  Uncontrolled or significant cardiovascular disease.

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women

Summary: The purpose of the study is to determine whether treatment with a PI3K inhibitor plus letrozole leads to an increase in pathologic clinical response and Objective Response Rate compared to treatment with placebo plus letrozole in patients with Breast cancer


Eligibility: Inclusion Criteria:
  1. Patient is an adult, female ≥ 18 years old at the time of informed consent
  2. Patient has a histologically and/or cytologically confirmed diagnosis of breast cancer
  3. Patient is postmenopausal.
  4. Patient has T1c-T3, any N, M0, operable breast cancer
  5. Patients must have measurable disease
  6. Patient has diagnostic biopsy available for the analysis of PIK3CA mutation and Ki67 level.
  7. Patient has estrogen-receptor and/or progesterone positive breast cancer as per local laboratory testing
  8. Patient has HER2 negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0 or 1+ as per local laboratory testing
  Exclusion Criteria:
  1. Patient has locally recurrent or metastatic disease
  2. Patient has received any systemic therapy (e.g. chemotherapy, targeted therapy, immunotherapy) or radiotherapy for current breast cancer disease before randomization.
  3. Patient with type 1 diabetes mellitus or not adequately controlled type 2 diabetes mellitus
  4. History of acute pancreatitis within 1 year of study entry
  5. Uncontrolled hypertension
  6. Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Nutritional Evaluation of Patients With Congestive Heart Failure

Summary: This study objective is to assess the nutritional status of Patients With Congestive Heart Failure.


Eligibility: Inclusion Criteria:
  -  Congestive heart failure patients between tne ages 40 to 90,all stages of the disease.
  Exclusion Criteria:
  -  non

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: H.E.R.O.S. Study: An Observational Study of the Cardiac Safety of Herceptin (Trastuzumab) in Patients With HER2-Positive Breast Cancer

Summary: This observational study will assess the safety of Herceptin (trastuzumab) in patients with HER2-positive breast cancer in routine clinical practice. Eligible patients will be followed for up to 4 years.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/= 18 years of age
  -  Histologically confirmed HER2-positive breast cancer
  -  Eligible to receive Herceptin as per Summary of Product Characteristics
  Exclusion Criteria:
  -  Contra-indications according to Summary of Product Characteristics

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: The Accuracy of Sentinel Node Biopsy of Breast Cancer With Sonographic Abnormal Axillary Lymph Nodes

Summary: -  This is a phase II, prospective, single-center, non-randomized, non-controlled study.
  -  Sentinel lymph node biopsy (SNB) is a standard staging procedure in early breast cancer. The potentially increasing false negative rate of SNB was concerned if the sonographic abnormal node was not excised. The aim of this study was to evaluate the accuracy of SNB in breast cancer with sonographic abnormal axillary lymph nodes.


Eligibility: Inclusion Criteria:
  -  histologically confirmsed primary breast cancer by core neelde biopsy or excisional biospy
  -  abnormal axillary lymph node was found by ultrasound examination before SLNB (abnormal nodes were defined as completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation and cortical thickness >3mm)
  -  ultrasound-guided FNA cytology of these nodes were performed
  -  the result of FNA cytology was negative (no tumour cell was found)
  -  patient planed to perform SLNB
  Exclusion Criteria:
  -  pathological diagnosed ductal carcinoma in situ by excisional biospy
  -  abnormal axillary lymph node was found by ultrasound examination but FNA cytology of these nodes were not performed
  -  the result of FNA cytology was positive (tumour cell was found)
  -  T4d tumour
  -  patient has recieved neo-adjuvant system therapy

Relevance to patient case: not relevant