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: Intraductal Papillary Mucinous Neoplasm With Malignant Change

Summary: Purpose:
  To investigate diagnostic performance of CT and MR in intraductal papillary mucinous neoplasm with malignant change according to international consensus guidelines 2012.
  Hypothesis: According to 2012 consensus guidelines, enhanced solid component and main pancreatic duct size of larger than 10 mm will be significant.

Detailed description: 1. Purpose
  -  To investigate diagnostic performance of CT and MR in intraductal papillary mucinous neoplasm with malignant change according to international consensus guidelines 2012
  2. Enroll criteria
  -  Patient who is suspected to have pancreas IPMN on imaging
  -  Interval between imaging study and surgery is less than 2 months
  -  Who is scheduled for surgery due to IPMN

Eligibility: Inclusion Criteria:
  -  Patients who is suspected to have IPMN by imaging study or clinician
  -  Time interval between imaging study and surgery less than 2 months
  Exclusion Criteria:
  -  Patients who have pathology results not by surgery
  -  Who is less than 20 years old
  -  Who cannot voluntarily agree study design

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: Behavioral Weight Loss and Exercise After Treatment (BEAT)

Summary: Overweight and physically inactive breast cancer survivors are at increased risk of breast cancer recurrence and mortality. Cancer treatment-related changes that likely mediate weight loss and exercise success include the long term effects such as fatigue, psychological distress and impaired executive (cognitive) function.
  This study will explore the variability in how breast cancer survivors respond to a behavioral weight loss intervention. The primary objectives include determining the degree to which success with a behavioral weight loss intervention in overweight breast cancer survivors is explained by measures of executive function as measured with task performance at 6 and 12 months and associated brain function imaging (fMRI), collected at baseline only.Additionally, the study is designed to determine the degree to which selected measures of cancer-related symptoms account for variance in the success of breast cancer survivors at 6 and 12 months following entry into a behavioral weight loss and exercise intervention.


Eligibility: Inclusion Criteria:
  -  Breast cancer diagnosis
  -  Received surgery +/- chemotherapy +/- radiation for treatment of a Stage I, II or III breast cancer. Ongoing treatment with monoclonal antibodies and/or anti-estrogen therapy is acceptable
  -  Completion of initial therapy 6 weeks prior to study initiation
  -  BMI of 27-45 kg/m^2
  Exclusion Criteria:
  -  Prior diagnosis of malignancy other than non-melanoma skin cancer (i.e. prior non-melanoma skin cancer is not an exclusion criteria)
  -  Medical conditions that limit food choices such as celiac sprue or inflammatory bowel disease
  -  Inability to walk on flat ground (or a treadmill) at 2.5 mph for 5 minutes
  -  Age <21 and >70
  -  Presence of body metal
  -  Psychotic or central nervous system impairment that would limit compliance with study requirements, including dementia
  -  Evidence of metastatic disease
  -  Symptomatic heart disease (chest pain or equivalent with activity)
  -  Exercise limiting pulmonary disease or need for oxygen to exercise
  -  Individuals taking mood stabilizing medications including: Lithium, valproic acid, also called divalproex sodium (Depakote), carbamazepine (Tegretol), lamotrigine (Lamictal), oxcarbazepine (Trileptal), olanzapine (Zyprexa), aripiprazole (Abilify), risperidone (Risperdal), ziprasidone (Geodon), clozapine (clorazil)
  -  Participants with an active neurologic disorder that affects the central nervous system, including seizures, and Parkinson's disease
  -  Weight loss of >10 lbs in the previous 6 months
  -  Participation in > 150 minutes of moderate intensity activity by self report, unless activity level by accelerometer is less than 150 minutes of moderate intensity 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: Effect of a Diet and Physical Activity Intervention in Breast Cancer Survivors

Summary: This is a single-arm pre-post pilot study, to assess changes in weight, quality of life and cardiorespiratory fitness after a diet and physical activity intervention in breast cancer survivors and to asses possible relation between these changes.

Detailed description: Aim:
  The present study assessed changes in weight, quality of life (QoL) and cardiorespiratory fitness (CRF) during a diet and physical activity (PA) intervention in breast cancer (BC) survivors and investigated the possible relation between these changes.
  Methods:
  The intervention of this 12-week single-arm pre-post pilot study involved group-based sessions: one-hour weekly diet sessions delivered by a dietician and 75-minute bi-weekly PA sessions of moderate-to-high intensity led by PA monitors. This intervention, designed to promote weight loss, targeted overweight/obese women who had completed treatment less than six months before recruitment. CRF and QoL were assessed before and after the intervention and compared using paired t-tests. Linear regression models, including CRF variables, weight change and participants' characteristics, were used to assess the independent association between change in CRF and change in QoL.

Eligibility: Inclusion Criteria:
  -  Female patients from the Catalan Institute of Oncology
  -  Aged 18 to 75
  -  Body mass index (BMI) of 25 kg•m-2 or more
  -  Completed chemotherapy and/or radiotherapy for breast cancer during the 6 months preceding recruitment
  Exclusion Criteria:
  -  First cancer, tumours of stage IIIB and above
  -  Morbid obesity (BMI ≥40 kg•m-2)
  -  Any condition that could not permit to follow the diet and PA intervention offered

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: Strain Imaging in Breast Cancer Patients Receiving Trastuzumab

Summary: The purpose of this research study is to evaluate the effects of the chemotherapeutic drug, Trastuzumab (Herceptin) on the heart. Trastuzumab (Herceptin) is used to treat specific types of breast cancer and is known to cause weakening of the heart. Unfortunately, little is know as to why this this happens. The investigators want to identify any factors that may lead to the early detection, treatment and prevention of the cardiotoxicity (heart problem) associated with this drug.

Detailed description: As a subject participating in this study the following information will be collected: complete past medical history including age, height, and weight will be done with each echocardiogram; blood pressure at clinic visits during treatment with trastuzumab, type of cancer will be noted, type of chemotherapy, doses of chemotherapy, type and dose of chemotherapy in the past, type and dose of radiation therapy received, names and doses of cardiac medications, results of cardiac tests, results of lab tests, family history of heart disease, and social history which will include risk factors for developing heart disease including tobacco and alcohol use. This information will be entered into a database for the investigators to try and detect any factors that may lead to the cardiotoxicity (heart problem) that may be caused by Trastuzumab (Herceptin).
  Any transthoracic echocardiogram (heart ultrasound) ordered will be further evaluated for special parameters that may help to detect weakening of the heart earlier than a normal ultrasound. An echocardiogram (heart ultrasound) is when a probe is placed on the chest and pictures are taken using sound waves and a special camera.

Eligibility: Inclusion Criteria:
  -  Age greater than 18 years
  -  Her 2 positive breast cancer.
  -  Patients who are currently receiving Trastuzumab (Herceptin).
  -  Patients who received Trastuzumab (Herceptin) after the formation of the UFHealth Medical Plaza pharmacy database was initiated.
  Exclusion Criteria:
  -  Age less than 18 years
  -  Patients who have not received Trastuzumab (Herceptin).
  -  Patients who received Trastuzumab prior to the formation of the UFHealth Medical Plaza pharmacy database.

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: Comparison of Nutrition Education Alone or With Acupuncture for Weight Loss in Breast Cancer Patients Post-Chemotherapy

Summary: This study looks at the benefit of adding acupuncture to nutrition education for weight loss in women with early stage breast cancer post-chemotherapy.

Detailed description: Obesity and weight gain are significant concerns for breast cancer survivors. Given the adverse consequences of weight gain after diagnosis, continued efforts to identify appropriate weight management interventions aimed at promoting overall health and long term survivorship are needed. In this study, the investigators will examine whether adding acupuncture to a nutrition education program for weight loss could improve short and long term weight loss among breast cancer survivors post treatment with chemotherapy.

Eligibility: Inclusion Criteria:
  -  Woman with a diagnosis of breast cancer, stage I, II, or III
  -  Age ≥ 18
  -  ECOG performance status ≤ 1
  -  Received treatment for breast cancer, and treatment must have been completed at least 2 weeks prior to enrollment in trial, but no longer than 1 year post-treatment.
  -  BMI ≥ 30
  -  Adequate bone marrow and organ function as determined by the consenting/enrolling investigator
  -  Signed informed consent
  -  Any receptor status
  -  Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits, and examinations
  Exclusion Criteria:
  -  Current chemotherapy or radiation therapy. Participants in study may still be receiving hormone or Herceptin treatment.
  -  Diagnosis of metastatic breast cancer
  -  Participation in other diet-based weight loss programs (ie. Patient should not be currently enrolled in Weight Watchers, Jenny Craig, Nutrisystem, etc.)
  -  Current use of commercial or natural/herbal weight loss supplements
  -  Major surgery within 1 month of starting study program and patients must have recovered from any effects of major surgery
  -  Other malignancies within the past three years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
  -  Personal history of an eating disorder
  -  Other serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection (including uncontrolled HIV, Hepatitis B or C), or any psychiatric disorder that prohibits obtaining 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: Application of Surgical Navigation System in Sentinel Lymph Node of Breast Cancer Research

Summary: The purpose of this study is to compare the sentinel lymph node (SLN) detection rate of early breast cancer patients between using Indocyanine green (ICG) and Methylene blue with a novel surgical navigation system.

Detailed description: Assessment of the sentinel lymph node (SLN) in patients with early stage breast cancer is vital in selecting the appropriate surgical approach. However, the existing methods, including methylene blue and nuclides, possess low efficiency and effectiveness in mapping SLNs, and to a certain extent exert side effects during application. Indocyanine green (ICG), as a fluorescent dye, has been proved reliable usage in SLN detection by several other groups. In this paper, we introduce a novel surgical navigation system to detect SLN with ICG. This system contains two charge-coupled devices (CCD) to simultaneously capture real-time color and fluorescent video images through two different bands. During surgery, surgeons only need to follow the fluorescence display. In addition, the system saves data automatically during surgery enabling surgeons to find the registration point easily according to image recognition algorithms. We aim to show that the usage of our surgical navigation system with ICG to detect SLNs in breast cancer patients is technically feasible.

Eligibility: Inclusion criteria: (Before the test, all the subjects required for meeting the entry requirements before they join the group)
  -  female patients;
  -  The preoperative core needle biopsy or open surgical excision biopsy diagnosis as breast cancer;
  -  tumor diameter ≤ 3cm;
  -  No clinical examination of suspicious axillary lymph node-positive;
  -  diagnosed clinical conditions can be directly surgery as I, II breast cancer patients;
  -  preoperative clinical or radiologic evidence without distant metastases (M0);
  -  signed informed consent.
  Exclusion criteria: (Before the test, the subjects under any one of items to meet the requirements can not be enrolled)
  -  Sentinel lymph node biopsy history had received surgery or axillary area;
  -  multi-center breast cancer or multiple lesions;
  -  clinical axillary lymph node metastasis have been found;
  -  mammary area had received neoadjuvant chemotherapy or radiotherapy;
  -  inflammatory breast cancer;
  -  pregnancy;
  -  no personal freedom and independent civil capacity.
  Exclusion criteria: (trials, subjects necessary to meet the requirements of any one item, exit the clinical trial research.)
  -  severe allergic reaction occurs;
  -  persistent allergic reaction;
  -  subjects were required to withdraw from a clinical trial;
  -  researchers consider it not appropriate to continue to participate in the clinical trial investigator.

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 LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer

Summary: The purpose of this trial is to explore the clinical utility of the three investigational agents in HR+, HER2- breast cancer. LEE011 (CDK4/6 inhibitor), BKM120 (PI3K-pan class I-inhibitor) and BYL719 (PI3K-alpha specific class I inhibitor) in combination with fulvestrant.
  This is a multi-center, open-label Phase Ib/II study. The Phase Ib portion of the study is a dose escalation to estimate the MTD and/or RP2D for three regimens: LEE011 with fulvestrant; LEE011 and BKM120 with fulvestrant; LEE011and BYL719 with fulvestrant.
  The Phase II portion of the study will be a randomized study to assess the anti-tumor activity as well as safety and tolerability of LEE011 with fulvestrant to LEE011 and BKM120 with fulvestrant, and LEE011 and BYL719 with fulvestrant in patients with ER+/HER2- locally advanced or metastatic breast cancer.
  Approximately 216 adult women with ER+/HER2- locally advanced or metastatic breast cancer will be enrolled.


Eligibility: Inclusion Criteria:
  -  Postmenopausal, Hormone receptor positive (HR+), HER2 negative breast cancer
  -  Unlimited number of lines of endocrine therapy and up to two lines of cytotoxic chemotherapy in the metastatic setting (Phase Ib)
  -  Unlimited number of lines of endocrine therapy and one line of cytotoxic chemotherapy in the metastatic setting (Phase II)
  Exclusion Criteria:
  -  HER2-overexpression in the patient's tumor tissue
  -  Inadequate bone marrow function or evidence of end-organ damage
  -  Severe or uncontrolled medical issues
  -  Diabetes mellitus
  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: Breast Cancer During Pregnancy

Summary: Patients are managed clinically according to ad hoc standards and scientific knowledge by a multidisciplinary team. Clinical decisions are made after a patient physician discussion. Blood and tissue samples are collected. Diagnostic, obstetric management surgical treatment, systemic treatment, perinatal results and follow up data are collected.


Eligibility: Inclusion Criteria:
  -  Patients with breast cancer diagnosed during pregnancy
  Exclusion Criteria:
  -  Patients who refuse 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: Integrating Palliative Care Into Self-Management of Breast Cancer

Summary: The purpose of this study is to test a psycho-educational intervention, Managing Cancer Care: A Personal Guide (MCC), that is intended to improve patients' knowledge of palliative care and to facilitate its timely integration into self-management of their breast cancer. The MCC will be tested with patients with Stage I-IV breast cancer at baseline, one, and three months following enrollment. The intervention group will receive the MCC, and the attention-control group will receive a symptom management toolkit. Participants' family caregivers will also be enrolled to provide information on patients' self-management. Investigators hypothesize that users of MCC, as compared to attention-control participants, will demonstrate improved knowledge, feelings, and behaviors related to self-management of their cancer care. This innovative research can help to establish palliative care as a mainstay of self-management interventions that target serious illnesses.


Eligibility: Inclusion Criteria:
  -  Over the age of 21
  -  Stage I-IV breast cancer
  -  Live in the State of Connecticut
  -  Speak English
  -  Receiving any kind of treatment for breast cancer
  -  Prognosis of at least 6 months

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: Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer

Summary: This study will determine whether CT-P6 and Herceptin are equivalent in patients with early-stage breast cancer undergoing neoadjuvant chemotherapy. Our hypothesis is that the pathologic complete response rate will be equivalent in patients treated with neoadjuvant CT-P6 or Herceptin. Patients will receive 8 cycles of neoadjuvant systemic therapy and up to 10 cycles of therapy in the adjuvant setting.


Eligibility: Inclusion Criteria:
  -  Patient who has histologically confirmed and newly diagnosed breast cancer
  -  Patient who has clinical stage I, II, or IIIa operable breast cancer according to AJCC (American Joint Committee on Cancer) Breast Cancer Staging 7th edition
  -  Patient who has HER2-positive status confirmed locally, defined as 3+ score by IHC (immuno-histochemistry).
  Exclusion Criteria:
  -  Patient who has bilateral breast cancer
  -  Patient who has received prior treatment for breast cancer, including chemotherapy, biologic therapy, hormone therapy, immunotherapy, radiation or surgery, including any prior therapy with anthracyclines.

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 Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors

Summary: This multicenter, randomized, double-blind study will estimate the efficacy, safety and tolerability of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in participants with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and in participants with phosphatase and tensin homolog (PTEN)-low tumors.


Eligibility: Inclusion Criteria:
  -  Histologically documented triple-negative adenocarcinoma of the breast that is inoperable locally advanced or metastatic and is not amenable to resection with curative intent
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  -  Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen, required prior to randomization
  -  Measurable disease, according to the RECIST v1.1
  -  Adequate hematologic and organ function within 14 days before the first study treatment
  -  For female participants of childbearing potential, agreement (by both participant and partner) to use an effective form of contraception for the duration of the study and for 6 months after last dose of study treatment
  Exclusion Criteria:
  -  Any previous therapy, including chemotherapy or hormonal or targeted therapy, for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast. Participants may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced triple negative adenocarcinoma, provided all treatments were completed greater than or equal to (>/=) 6 months prior to Cycle 1 Day 1. Locally recurrent disease must not be amenable to resection with curative intent
  -  Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1
  -  Known Human Epidermal Growth Factor Receptor 2 (HER2) positive, erythrocyte receptor (ER) positive, or progesterone receptor (PR) positive breast cancer
  -  Previous therapy with Akt, PI3K, and/or mTOR inhibitors
  -  Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study
  -  Known presence of the brain or spinal cord metastasis, as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments

Relevance to patient case: not relevant