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: Deployment of American Heart Association Heart Failure Protocols and Content Within the Intel® Health Guide System

Summary: This purposed of this study is to ascertain if the implementation of remote patient management systems utilizing American Heart Association (AHA) guideline-based heart failure protocols and educational content can improve the management of patients with congestive heart failure.

Detailed description: This prospective, comparative study uses a pre-post test design to ascertain if the implementation of remote patient management systems utilizing AHA guideline-based heart failure protocols and educational content can successfully address the following objectives:
  -  validate the suitability of the Intel Health Guide to deploy AHA guideline-based patient care protocols and health content to patients managing congestive heart failure
  -  confirm that the AHA protocols as deployed on the HGS are supportive for clinicians following the AHA guidelines in a telehealth environment
  -  validate and verify that the data intended to be collected was effectively collected
  -  measure patient and provider satisfaction with use of the system

Eligibility: Inclusion Criteria:
  -  Patient has a diagnosis of Heart Failure NYHA and is currently in functional class II- IV status.
  -  Patient has been hospitalized for an episode of acute HF decompensation within the last 30 days.
  -  Patients with other co-morbidities such as atrial fibrillation, diabetes, coronary artery disease, COPD, hypertension, may be included in this evaluation. These conditions shall be documented during enrollment.
  -  Have telephone line or broadband internet availability to connect Intel® Health Guide.
  -  Are physically and mentally capable to complete the monitoring process or have a caregiver capable of assisting in the use of the Intel® Health Guide.
  -  Will be willing and able to sign an informed consent form to participate in this evaluation for a duration of 60 days.
  -  Live within a reasonable distance (30 miles or less) from the institution.
  Exclusion Criteria:
  -  Have a life expectancy of less than six months.
  -  Live in a nursing home or other multi-member assisted living facility.
  -  Intend to be away from their home for more than 2 weeks (14 days) total during the 60 days.
  -  Are unable to read English at a minimum 5th grade level.
  -  Do not live within a reasonable distance (30 miles or less) from the institution.

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: BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer

Summary: This is a prospective, multi-center, open-label, single arm, phase II study with a 2-stage design and Bayesian interim monitoring to investigate the safety and efficacy of BEZ235 in patients with progressive metastatic HR+ HER2- breast cancer who have received at least one prior line of endocrine therapy and two to three prior lines of chemotherapy for metastatic disease. Patients will be stratified into 3 groups according to their PI3K (phosphatidylinositol 3-Kinase) pathway activation status.


Eligibility: Inclusion Criteria:
  -  Female ≥ 18 years
  -  ECOG performance status ≤ 2
  -  Histologically and/or cytologically confirmed diagnosis of breast cancer presenting with metastatic disease (hormone receptor positive and HER2 negative)
  -  Known PI3K activation status (defined by PIK3CA (Phosphoinositide-3-kinase, catalytic, alpha polypeptide) mutation and PTEN PTEN (Phosphatase and Tensin Homolog) mutation/expression)
  -  Prior treatment with at least one prior line of endocrine therapy and at least two and no more than three prior lines of chemotherapy for metastatic breast cancer
  -  Objective and radiologically confirmed progression of disease after prior treatment and at least one measurable lesion as per RECIST
  -  Adequate bone marrow and organ function
  Exclusion Criteria:
  -  Previous treatment with PI3K and/or mTOR inhibitors
  -  Symptomatic Central Nervous System (CNS) metastases
  -  Concurrent malignancy or malignancy in the last 5 years prior to start of study treatment
  -  Wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug
  -  Active cardiac disease (e.g. Left Ventricular Ejection Fraction (LVEF) < 50%, QTcF > 480 msec on screening ECGelectrocardiogram (ECG), unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias)
  -  Inadequately controlled hypertension
  -  Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235
  -  Treatment at start of study treatment with drugs with a known risk to induce Torsades de Pointes, moderate and strong inhibitors or inducers of isoenzyme CYP3A4, warfarin and coumadin analogues, LHRH agonists
  -  History of photosensitivity reactions to other drugs
  -  Pregnant or nursing (lactating) woman
  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 Prevention Education

Summary: We will develop and evaluate a community-based approach for disseminating comparative effective reviews (CERs) about breast cancer prevention to African American women. The specific aims of our research, as shown below, will target this population because of persistent disparities in breast cancer morbidity and mortality among this population. Our primary aims are:
  1. To evaluate uptake of a community-based strategy for disseminating CERs about breast cancer prevention to African American women based on sociodemographic characteristics, beliefs about medical research, and medical history. We predict that participation in a community forum will be higher among women with greater socioeconomic resources, those who have a family history of breast cancer, and women who have more positive beliefs about research.
  2. To evaluate the impact of evidential versus non-evidential content about breast cancer prevention on psychological and behavioral outcomes that include: knowledge of breast cancer risk factors and prevention strategies, communication with individuals in their social and medical network, and distrust of medical research. We predict that women who receive evidential content that is specific for African American women will report greater knowledge about breast cancer risk factors and prevention strategies, will be more likely to discuss breast cancer prevention strategies with individuals in their social and medical network, and will report greater reductions in distrust of medical research compared to those who receive non-evidential content.


Eligibility: Inclusion Criteria:
  -  African American women
  -  Ages 35-70
  -  No personal history of cancer
  -  Resident of Philadelphia metropolitan area
  Exclusion Criteria:
  -  Non-African American
  -  Male
  -  Under 35 or over 70 years of age
  -  Personal history of cancer
  -  Not a resident of Philadelphia Metropolitan Area

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: Getting Back on Track: An Educational Group for Women With Breast Cancer

Summary: As the number of women who survive breast cancer continues to grow, more attention is being paid to their quality of life and the disease's long-term effects. The transition from patient to survivor, also termed the "re-entry transition", can be a very difficult and stressful time. A brief psychosocial intervention delivered at this important transition time may address the challenges that women face at re-entry, facilitating greater adaptation and more optimal recovery. The purpose of the proposed RCT is to test the acceptability and effectiveness of a single-session group psychoeducational intervention led by a multi-disciplinary team on adjustment to survivorship. A randomized controlled trial design (RCT) will be used to recruit 440 women attending the breast clinic at Princess Margaret Hospital in Toronto. Participants will be recruited while completing their adjuvant radiotherapy and those who agree to participate will complete the baseline questionnaire package (T0). They then will be randomized to receive either: (1) standard print material (CRL group n=220); or (2) standard print material and a single session group psychoeducational intervention (INT group n=220). Two weeks following randomization, participants in the CRL group will be given the "Getting Back on Track: Life after Treatment" booklet (current standard care), which includes information on the new health care team, physical side-effects, diet and exercise, emotional and social needs and returning to everyday life. Participants in the INT group will receive the same booklet and will also attend a 2- hour psychoeducational group session facilitated by a multidisciplinary team. Participants in both groups will be asked to complete the questionnaire package again at 3 months (post-1) and 6 -months (post-2) following the completion of cancer treatment. Participants in the INV group will also be asked to rate their satisfaction with the class and provide feedback on the content. The proposed intervention will be one of the few clinical interventions designed to address the service gap in helping women to make the transition from patients to survivors by using a single-session psychoeducational group intervention.


Eligibility: Inclusion Criteria:
  -  outpatients attending treatments at PMH
  -  have a diagnosis of breast cancer;
  -  have undergone initial treatment for breast cancer;
  -  are receiving adjuvant radiation therapy as last hospital-based component of treatment;
  -  are able to speak, read and write English.
  Exclusion Criteria:
  -  metastatic disease
  -  local recurrence
  -  cognitive impairment
  -  if they are an inpatient

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: Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer

Summary: If AZD6244 is able to increase ER expression in ER-negative/low cancers then it may be possible to effectively use hormonal therapy in these patients resulting in improved outcomes. The investigators propose a single-arm Simon two-step study to examine whether treatment with AZD6244 will result in increased ER expression in ER-negative/low primary breast tumors.


Eligibility: Inclusion Criteria:
  -  Female breast cancer patient > 18 years.
  -  Patients must have biopsy-proven clinical Stage Ic-III invasive breast carcinoma with ≤ 10% ER expression by immunohistochemistry (IHC) analysis.
  -  Patients must have a pre-treatment baseline core biopsy or incisional biopsy available for additional testing (ER, protein/gene expression analysis).
  -  Patients must have sufficient tumor remaining following diagnostic biopsy that requires an additional definitive surgical procedure per the standard of care. Planned procedure may include lumpectomy or mastectomy as clinically indicated.
  -  Patients must have an ECOG Performance Status of 0 - 1.
  -  Patients must have the ability to understand and willingness to sign an English or a Spanish language written informed consent document.
  Exclusion Criteria:
  -  Male breast cancer patient.
  -  Patients who are pregnant or breast-feeding are excluded from the study due to potential harm to the fetus or nursing infant from the study therapy. Patients of reproductive potential must consent to use of contraception or abstinence to be eligible for the study.
  -  Patients may not have received prior chemotherapy or hormonal therapy for treatment of the current breast cancer.
  -  Patients should not have known or strongly suspected BRCA mutation by history (genetic testing not required).
  -  Patients will have pre-study testing, including history and physical exam, complete blood count, and measurement of renal and hepatic function. Patients will be ineligible for the study if significant abnormalities are detected, in accordance with good medical practice.

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: Enumeration and Molecular Characterization of Circulating Tumour Cells in Women With Metastatic Breast Cancer

Summary: Women with metastatic breast cancer, receiving first line treatment of any kind (chemotherapy, endocrine treatment or treatment with antibodies) will be included in this trial. In connection to treatment, blood samples for determination and enumeration of circulating tumour cells will be collected at different time points. Serum and plasma will be collected and stored for future analysis of RNA and DNA.


Eligibility: Inclusion Criteria:
  -  Women with metastatic breast cancer
  -  ECOG performance status 0-2
  -  Age over18 years
  -  Signed informed concent
  -  Predicted life expectancy over 2 months
  -  Planned for first line systemic treatment for metastatic disease (chemotherapy, antibody treatment or endocrine treatment)
  -  Standard imaging evaluation within 4 weeks of inclusion
  -  Planned for standard imaging within 16 weeks after start of therapy
  Exclusion Criteria:
  -  Prior medical therapy for metastatic disease (prior adjuvant chemotherapy, radiotherapy or endocrine therapy is permitted)
  -  Inability to understand information about the study
  -  Other malignant disease with the exception of curatively treated basal cell or squamous cell cancer of the skin and cancer in situ of the cervix

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: Stereotactic Body Radiotherapy for Head and Neck Tumors

Summary: This study will evaluate the local control rates as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of benign and malignant head and neck tumors.

Detailed description: This single site, non-randomized, prospective, phase IV study includes 3 patient groups to be treated with SBRT:
  -  Benign tumors, such as paraganglioma, chordoma, chondrosarcoma, as the sole treatment or to gross residual disease after maximal safe resection
  -  Malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, after initial external beam radiation (Residual Disease Group)
  -  Unresectable malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, adenocarcinomas, and sarcomas which are recurrent after prior radiation (Primary RT Group) Data collected will include baseline patient demographics, pathology data, radiation therapy procedure, tumor recurrence data, and toxicities.
  Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.

Eligibility: Inclusion Criteria:
  -  Patient age > 18 years
  -  Zubrod performance status of 0-3
  -  Benign head and neck tumors such as paragangliomas, chordoma, chondrosarcoma
  -  Malignant head and neck cancers such as invasive squamous cell carcinoma, adenocarcinoma, nasopharyngeal carcinoma, salivary gland cancers, and sarcoma
  -  Signed study-specific consent form
  Exclusion Criteria:
  -  Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
  -  Patients with psychiatric or addictive disorder that would preclude 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: Tumour Registry Breast Cancer

Summary: The registry aims to collect and analyse information on the antineoplastic treatment of breast cancer in daily routine practice of office-based and clinic-based medical oncologists in Germany.

Detailed description: The TMK is a prospective, longitudinal, nation wide cohort study with the purpose to record information on the antineoplastic treatment of breast cancer in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics, biomarker testing and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.
  The impact of nutrition (MaNut) and physical activity (MaNut) on the course of the adjuvant disease will be examined, as well as long-term effects of adjuvant treatment (MaTox) and the multiple patient-reported outcomes (MaLife).

Eligibility: Inclusion Criteria:
  -  Breast cancer
  -  18 years and older
  -  Antineoplastic or antihormonal treatment
  Exclusion Criteria:
  -  No breast cancer
  -  Below 18 years
  -  No antineoplastic or antihormonal treatment

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: Proton Therapy for Lymph Nodes in Breast Cancer

Summary: The purpose of this study is to determine if proton radiation therapy will reduce the amount of heart that is exposed to radiation, thereby decreasing the frequency and/or severity of any cardiac side effects.


Eligibility: Inclusion Criteria:
  -  Pathologically confirmed invasive adenocarcinoma of the breast stage I-III (TX, T0-4, N0-3) with medially located tumor and/or axillary node invasion.
  -  Patients must have undergone either mastectomy or breast conservation surgery.
  -  Patients are required to have axillary staging which can include sentinel node biopsy alone if sentinel node is negative.
  -  Patient must require peripheral lymph node radiation per physician discretion.
  Exclusion Criteria:
  -  Evidence of distant metastasis (M1).
  -  Prior radiotherapy to the area of interest.
  -  Prior history of cardiovascular disease per physician discretion.
  -  Prior or concurrent cancer other than non-melanomatous skin cancer unless disease free for at least 5 years.
  -  Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma.

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 Jewels in Our Genes Study - an African American Family Study of Breast Cancer

Summary: The research team is studying why some African American families have multiple cases of breast cancer.
  This study will help to better understand if there are undiscovered genes unique to African Americans that may predict early breast cancer risk.
  Breast cancer survivors AND their relatives who are also breast cancer survivors are being recruited to the study.


Eligibility: Inclusion Criteria:
  -  Black/African American
  -  Ever diagnosed with breast cancer
  -  Have at least one living blood relative ever diagnosed with breast cancer, who is also willing to participate
  -  Live in the U.S.
  Exclusion Criteria:
  -  Tested positive for BRCA mutations

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: Effects of Controlled Ovarian Hyperstimulation (COH) With Letrozole and Gonadotropin

Summary: Fertility drugs have the effect of increasing hormone levels. Higher hormone levels from infertility treatments may increase breast cancer risk, but there has not been enough research to know for sure. Researchers want to use a method of taking breast tissue cells from women who are having infertility treatment. The breast tissue cells might show changes that would indicate an increased risk of cancer. The method of taking the breast tissue cells is called Fine Needle Aspiration (FNA).
  The purpose of this study is to examine the changes in breast tissue, in women at high risk of breast cancer who are being treated with controlled ovarian hyperstimulation.


Eligibility: Inclusion criteria:
  1. Women must be at increased risk for breast cancer based on any of the following criteria:
  -  Age 30 or older with no prior live birth.
  -  Mutations associated with hereditary cancer (BRCA1 or 2, P53, PTEN)
  -  Family history of breast cancer including one first degree or multiple second degree relatives
  -  History of chest radiation before age 30
  -  Multiple prior breast biopsies
  -  Precancerous conditions (DCIS, LCIS, AH)
  -  Prior history of breast or ovarian cancer
  -  Estimated mammographic breast density > 50%
  2. Must be undergoing infertility treatment at the University of Kansas with Controlled Ovarian Hyper-stimulation (COH)
  3. Must be between the ages of 21-45 (both inclusive) with Day 3 FSH less than 12 IU/L, Day 3 E2 less than 80 pg/ml
  Exclusion criteria:
  1. Women under 21 or over 45 years old
  2. Day 3 FSH over 12 IU/L, Day 3 E2 over 80 pg/ml
  3. Women who do not meet risk criteria above
  4. History of hypersensitivity to letrozole or gonadotropin
  5. Uterine and adnexal pathology
  6. Use of clomid or gonadotropin within 30days before the letrozole cycle
  7. Any severe chronic disease of relevance for reproductive function

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: Pre-Operative Study of PF-4691502 With Letrozole Compared To Letrozole Alone In Patients With Early Breast Cancer

Summary: PF-04691502 is an inhibitor of PI3K and mTOR kinase. Published data support the hypothesis that a PI3K/mTOR antagonist in combination with letrozole might mitigate the intrinsic or acquired resistance to hormonal therapy and restore hormone sensitivity in high risk (high Ki-67) patient population of hormone-sensitive breast cancers. In addition, Ki-67, a marker of cellular proliferation, could be used to select those patients who benefit from treatment with a PI3K-pathway inhibitor.

Detailed description: The study was prematurely discontinued on 09Oct2012 due to the tolerability findings in 2 clinical studies testing PF-04691502 that have prompted the Sponsor to re-evaluate the strategic goals of the program. In the study B1271003 an unexpected frequency of severe skin toxicity was observed and in the study B1271004 5 cases of drug induced pneumonitis were reported.

Eligibility: Inclusion Criteria:
  -  Phase 1 - Postmenopausal women with diagnosis of breast cancer, metastatic disease or locally advanced disease / Estrogen Receptor positive and HER-2 negative / candidate to receive Letrozole
  -  Phase 2 - Postmenopausal women with newly diagnosed primary breast cancer / Estrogen Receptor positive and HER-2 negative / Ki-67 levels >10% positive cells
  -  Phase 1 & 2 - Glucose control, adequate bone marrow, liver, renal, and cardiac function
  Exclusion Criteria:
  -  Inflammatory carcinoma / Prior therapy with an agent active on PI3K and/or mTOR / Significant gastrointestinal abnormalities, which may impair intake, transit or absorption of the study drugs / Current or anticipated need for food or drugs that are known inhibitors or inducers of CYP3A4

Relevance to patient case: definitely relevant