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: Injection Methods in Finding the Sentinel Lymph Node During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Invasive Breast Cancer

Summary: RATIONALE: Diagnostic procedures, such as lymphoscintigraphy using an injection under the nipple or near the tumor, may help doctors find out how far the disease has spread.
  PURPOSE: This clinical trial is studying two different injection methods to compare how well they find the sentinel lymph node during lymphatic mapping and sentinel lymph node biopsy in patients with invasive breast cancer.

Detailed description: OBJECTIVES:
  -  Compare subareolar injection with peritumoral injection in identifying the sentinel node during breast lymphatic mapping in patients with invasive breast cancer.
  -  Compare the lymphatic drainage patterns using lymphoscintigraphy of the breast with subareolar injection vs peritumoral injection.
  OUTLINE: At least 2 days before scheduled surgery, patients receive technetium Tc 99m sulfur colloid by peritumoral injection followed by lymphoscintigraphy. Images are obtained at 30 minutes and after 2 and 3 hours, provided no drainage is noted. Patients then receive technetium Tc 99m sulfur colloid by subareolar injection followed by another lymphoscintigraphy.
  At the time of surgery, patients receive isosulfan blue by subareolar injection. A handheld gamma probe is used to locate the sentinel node. If the sentinel node is identified, it is excised and the scheduled breast surgery is performed. If the sentinel node cannot be identified, patients undergo the scheduled breast surgery.
  PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 12.5 months.

Eligibility: Inclusion Criteria:
  1. Patients must have either pathologic, radiologic or clinical evidence of breast cancer with invasion, suspicious for invasion or microinvasion.
  2. Patients who are candidates for a total mastectomy or segmental mastectomy or axillary dissection.
  3. Patients who have undergone neoadjuvant chemotherapy who have an FNA confirmed lymph node positive for metastatic disease prior to induction chemotherapy and are then found to have grossly palpable disease but are ultrasound node negative at time of study entry.
  4. Patients must sign an informed consent and be registered before the procedure is performed.
  Exclusion Criteria:
  1. A pregnancy test will be required preoperatively in women of childbearing potential and patients who are pregnant will be excluded from this study.
  2. Patients who have undergone neoadjuvant chemotherapy who have an FNA confirmed lymph node metastatic disease prior to induction chemotherapy and are then found to have grossly suspicious palpable disease and are ultrasound node positive at the time of study entry.
  3. Patients with known allergy to isosulfan blue dye or any related compounds.

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: Changes in Breast Density and Breast Cancer Risk in Women With Breast Cancer and in Healthy Women

Summary: RATIONALE: Studying mammograms for breast density changes over time may help doctors predict breast cancer risk.
  PURPOSE: This natural history study is looking at changes in breast density and gathering health information over time to assess breast cancer risk in women with breast cancer and in healthy women.

Detailed description: OBJECTIVES:
  -  Characterize each woman's individual mammographic density (MD) longitudinal change trajectory in women with breast cancer and in healthy female participants to assess within-individual MD longitudinal change and breast cancer risk.
  -  Examine whether these patients or healthy participants manifest different patterns of within-individual change in MD and evaluate predictors of across-individual differences.
  -  Determine whether the developmental profile of MD differs systematically between these patients and healthy participants.
  OUTLINE: This is a prospective, retrospective, controlled study. Patients and healthy participants are frequency-matched by age (± 2 years) and ethnicity.
  -  Questionnaire: Patients and healthy participants complete a self-administered questionnaire providing detailed information on breast cancer risk factors, including demographics, behavioral and lifestyle factors, reproductive history, family history of breast cancer, comorbidities, medication and hormone replacement therapy use, and breast cancer screening history. This information is then cross-validated with documented data abstracted from medical records to provide a longitudinal and historical framework for assessing individual risk.
  -  Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis.
  PROJECTED ACCRUAL: A total of 1500 patients and 1500 healthy participants will be accrued for this study.

Eligibility: Inclusion Criteria:
  -  Patient at the University Hospitals Breast Center and primary care clinics within the University Hospitals system
  -  Have at least 3 screening mammograms since 1994
  -  for cases, diagnosis with breast cancer between 2004-2006
  Exclusion criteria:
  -  having had irregular screening (less than 3 mammorgrams since 1994)
  -  Having breast implants
  -  Known carriers of BRCA1/BRCA2 genes
  -  Unable to give written 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: Blood Sample Collection and Health Information Collection From Patients With Invasive Breast Cancer and Their Brothers and Sisters

Summary: RATIONALE: Collecting blood samples and health information from patients with invasive breast cancer and from their brothers and sisters over time may help the study of cancer in the future.
  PURPOSE: This study is collecting blood samples and health information over time from patients with invasive breast cancer and from their brothers and sisters.

Detailed description: OBJECTIVES:
  -  Collect blood samples and medical and background information from patients with invasive breast cancer and their affected or unaffected siblings.
  OUTLINE: Patients and their siblings undergo blood collection. They also complete medical and background questionnaires.
  Patients and their siblings are followed annually for 5 years.
  PROJECTED ACCRUAL: A total of 1,000 patients and siblings will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  Pathologically confirmed invasive breast cancer (patient)
  -  No ductal carcinoma in situ
  -  Affected OR unaffected sibling
  -  Affected sibling must have had (or currently has) breast cancer only
  -  Unaffected sibling must be female
  -  No deceased siblings
  -  Must be a full-blood related sibling
  -  Patients receiving treatment on clinical trial ECOG-E1Y97 or ECOG-E3Y92 are not eligible
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

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 Phase II Combination of Trastuzumab and Ixabepilone Versus Trastuzumab and Docetaxel in Patients With Advanced and/or Metastatic Breast Cancer

Summary: The purpose of this randomized, Phase 2 open-label study was to assess the response rate of participants with Human Epidermal Growth Factor Receptor 2 (Her2+) locally advanced and/or metastatic breast cancer (not previously treated with chemotherapy or trastuzumab) to treatment with ixabepilone plus trastuzumab and/or docetaxel plus trastuzumab.


Eligibility: Inclusion Criteria:
  -  Locally advanced or metastatic HER2+ breast cancer not previously treated with chemotherapy or trastuzumab.
  -  Subjects who had received prior (neo)adjuvant chemotherapy or trastuzumab were eligible except if they relapsed within 12 months after the last dose of a taxane or trastuzumab given as (neo)adjuvant therapy.
  -  Measurable disease
  -  Left Ventricular Ejection Fraction (LVEF) ≥50%
  Exclusion Criteria:
  -  Prior chemotherapy or trastuzumab for metastatic breast cancer (MBC)
  -  Relapse within 1 year after (neo)adjuvant taxane or trastuzumab
  -  Neuropathy > Grade 1
  -  Significant cardiovascular disease
  -  Any brain metastases

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: Cardiomyopathy Tissue Bank in a Cancer Population

Summary: The goal of this laboratory research study is to collect and store blood and tissue from patients who have a diagnosis of heart disease and may be at a high risk for the development of heart failure. This blood may be used in the future to identify genes that may play a role in developing congestive heart failure (CHF) from chemotherapy or other sources.

Detailed description: You will have a one time blood draw of 2 teaspoons of blood for use in future research. This blood may be studied in the future to try to find possible genetic or biochemical markers that may be the cause of CHF. Your blood will be drawn either on an outpatient basis or during a routine visit to the hospital. If you already have a central line or an IV placed, the blood will be drawn at these sites to decrease the pain and discomfort of the blood draw. The information obtained in this study will not be put into your medical records.
  This is an investigational study. All will be enrolled at MD Anderson.

Eligibility: Inclusion Criteria:
  -  Patients who are at high risk for developing Cardiomyopathy or Congestive Heart Failure.
  -  Patients two months of age and older.
  Exclusion Criteria:
  -  Those that are not willing to sign an 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: High Risk Breast Cancer Screening Program

Summary: Objectives:
  -  To screen population with high risk for breast cancer
  -  To promote the concept and importance of surveillance mammography
  -  To find out the incidence of breast cancer in population who are in high risk for breast cancer
  -  To collect blood samples for molecular analysis


Eligibility: Inclusion Criteria:
  -  Female
  -  > 40 years of age
  -  Women who have first-degree relative suffered from breast cancer
  -  Women who have first-degree relative suffered from ovarian cancer
  -  Family history of male breast cancer
  -  Family history of breast cancer (not necessarily first degree relatives) diagnosed before age of 40
  -  Family history of breast cancer (not necessarily first degree relatives) affecting 2 or more family members
  -  Personal history of ovarian cancer
  -  Personal history of premalignant conditions of breast and ovary
  Exclusion Criteria:
  -  Women with mammogram within one year

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 Everolimus (RAD001) in Patients With Recurrent Glioblastoma Multiforme (GBM)

Summary: This study will define the safety and efficacy of Everolimus (RAD001) administered daily in patients with glioblastoma multiforme (GBM)

Detailed description: This was a multicenter, open label, randomized study of RAD001 dosed daily in patients with recurrent GBM. The study was conducted with 2 parallel groups of patients. Group 1 was designed to study the biological effects of RAD001 in patients scheduled to undergo salvage surgical resection, and Group 2 was to enroll patients who were not scheduled for surgery. Patients in Group 1 were randomly assigned to one of three pre-surgery treatment groups (0, 5 or 10 mg/day RAD001 for 7 days). All patients in Group 2 were to receive a fixed daily dose of 10 mg/day oral RAD001.

Eligibility: Inclusion Criteria:
  -  Age 18 years of age or older
  -  Histologically confirmed Glioblastoma Multiforme (GBM)
  -  Radiographic evidence of disease progression
  -  Patients must have evaluable contrast enhancing tumor
  -  Availability of paraffin blocks or unstained pathology slides for biomarker studies
  -  Karnofsky Performance Status of greater than or equal to 60%
  Exclusion Criteria:
  -  Prior treatment with Mammalian target of rapamycin (mTOR) inhibitor
  -  History of another malignancy within 3 years
  -  Cardiac pacemaker
  -  Ferromagnetic metal implants other than those approves as safe for use in Magnetic resonance imaging (MRI) scanners
  -  Claustrophobia
  -  Obesity
  -  Unstable systemic diseases
  -  Elevated cholesterol or triglycerides
  -  Radiation therapy or cytotoxic chemotherapy <=4 weeks prior to study enrollment. Patient must have recovered from the toxic effects of a prior chemotherapy.
  -  Patients must be off all enzyme inducing anticonvulsants for at least 2 week before study enrollment can occur
  -  Need for increasing dose of steroids. Patients on a stable or tapering dose of steroids >=7 days were permitted.

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: Level of Physical Activities in Patients Before and After Breast Cancer Treatment

Summary: Subjects and Methods: 303 patients who had already had the diagnosis of breast cancer and had already been treated at the Ambulatory of Botucatu School of Medicine were selected. The measuring tool used for the level of physical activities was the International Physical Activities Questionnaire (IPAQ-short version), validated by the World Health Organization - Physical Activities and Health International Committee (1998).

Detailed description: Introduction: Breast cancer is the most common malignant neoplasy in women. The risk for breast cancer in a lifetime is high among north-american women, about one out of eight, with 66% of the cases occurring after menopause and 15% when women are under 40 years old. Published cohort studies show clear evidences that women who practice intense physical activities have the risk for breast cancer reduced. The risk reduction for these women is 70%, and 10% for those who practice physical activities at a low level. During adolescence and adult age, moderate to intense physical activities may protect against a future breast cancer development. But some questions still need to be answered: Were women with a breast carcinoma diagnosis already physically active during life? Were there changes in these physical activities after treatment? Why? Objectives: The aim of this study was to identify the level of physical activities in patients before and after breast carcinoma treatment, and to observe if there were changes in the level of these activities. Subjects and Methods: 303 patients who had already had the diagnosis of breast cancer and had already been treated at the Ambulatory of Botucatu School of Medicine were selected. The measuring tool used for the level of physical activities was the International Physical Activities Questionnaire (IPAQ-short version), validated by the World Health Organization - Physical Activities and Health International Committee (1998).

Eligibility: Inclusion Criteria:
  -  Patients whit diagnosis of breast cancer

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: COmpliance and Efficacy in Mono and Combination Tablet Study ATacand/Atacand Plus

Summary: To evaluate compliance and patients' satisfaction in mono and combination treatment of Candesartan cilexetil (Atacand)/ Candesartan cilexetil 16mg, hydrochlorothiazide 12.5mg (Atacand plus) in hypertension.


Eligibility: Inclusion Criteria:
  1. Patients who have consented to participation/data release in this study
  2. Patients diagnosed with hypertension and prescribed with atacand/atacand plus by the physician based on clinical decision
  Exclusion Criteria:
  1. Secondary hypertension requiring therapy other than antihypertensive medication
  2. Patients not prescribed with atacand/atacand plus based on safety reasons or any other reason as determined by the physician
  3. Women in pregnancy or lactation
  4. Patients enrolled in any other studies

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: Prospective & Retrospective Data Collection of Breast Cancer Cases From 2000 to Present

Summary: Prospective & Retrospective data collection of breast cancer cases from 2000 to present


Eligibility: Inclusion Criteria:
  -  Patients with breast cancer

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 Chemotherapy in Operable Breast Cancer, Phase III Study Comparing a Short Intensive Pre-operative Chemotherapy With the Same Therapy Initiated Shortly After Surgery(Peri-operatively)(POCOB)EORTC 10902)

Summary: Pre-operative chemotherapy in operable breast cancer, phase III study comparing a short intensive pre-operative chemotherapy with the same therapy initiated shortly after surgery (peri-operatively) (POCOB) (EORTC 10902)


Eligibility: Inclusion Criteria:
  Disease Characteristics:
  -  Palpable, operable breast cancer that has been diagnosed by core needle biopsy (mandatory for T1c tumors) or fine needle aspiration within 21 days prior to entry
  -  Stage T1c-4b, N0-1, M0
  Hormone receptor status:
  -  Not specified
  -  No bilateral breast cancer
  Prior/Concurrent Therapy:
  -  No previous treatment for breast cancer
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  No previous chemotherapy
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Not specified
  Surgery:
  -  Core needle biopsy or fine needle aspiration within 21 days prior to entry
  -  Repeated core needle biopsy permitted
  Patient Characteristics:
  Age:
  -  16 to 70
  Sex:
  -  Women only
  Menopausal status:
  -  Not specified
  Performance status:
  -  WHO 0-2
  Hematopoietic:
  -  WBC at least 4,000
  -  Platelets at least 100,000
  Hepatic:
  -  Bilirubin no greater than 2.8 mg/dL (50 micromoles/L)
  Renal:
  -  Creatinine no greater than 1.3 mg/dL (120 micromoles/L)
  Cardiovascular:
  -  No congestive heart failure
  -  No significant arrhythmia
  -  No bilateral bundle branch block
  -  No recent myocardial infarction
  -  No uncontrolled hypertension (diastolic pressure greater than 110 mm Hg)
  Other:
  -  No male breast cancer
  -  No pregnant or nursing women
  -  No second malignancy except adequately treated:
  -  Nonmelanomatous skin cancer
  -  Cervical cancer

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: Registry of Mastectomy for Breast Cancer Risk Reduction

Summary: This is a registry for patients who have a risk-reduction mastectomy ("prophylactic mastectomy") due to being at high risk for developing breast cancer, followed by breast reconstruction. Eligible patients include those who have a breast cancer-related gene, a strong family history of breast cancer, or a personal history of high-risk conditions such as cancer in the other breast or ductal carcinoma in situ (DCIS). Patients are enrolled in the registry before surgery, and are followed for up to ten years afterwards. In addition to studying medical outcomes, we will periodically survey patients for quality-of-life issues and psychological well-being. There is no compensation for being enrolled in this registry. This registry is conducted through the Department of Plastic Surgery at Georgetown University Hospital, and is a sub-registry to the Fisher Familial Cancer Registry at the Lombardi Comprehensive Cancer Center at Georgetown University.


Eligibility: Inclusion Criteria:
  -  Patients at an elevated risk for breast cancer.
  Exclusion Criteria:

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: Local Surgery for Metastatic Breast Cancer

Summary: Primary treatments for metastatic breast cancer are chemotherapy and radiation therapy, and surgery is reserved for tumor related complications such as bleeding. Retrospective studies showed that surgical removal of the primary tumor improves survival of patients with metastatic breast cancer at diagnosis. We hypothesis and testing that surgical removal of the primary tumor will lead to an improvement of overall survival

Detailed description: This is a randomised, controled clinical trial. Our aim is to observe whether primary surgery improves survival in metastatic breast cancer. Women who have metastatic breast cancer at the initial diagnosis will be included in the study. There will be two study arms: primary surgery and systemic chemotherapy groups.
  In the primary surgery group patients will have adjuvant therapies after they had the proper surgery. In the systemic chemotherapy group patients will be followed after their initial therapy and will have surgery only if they have locoregional problems (such as wide necrosis or bleeding, etc). During the follow-up period, patients will be seen in every 6 months.

Eligibility: Inclusion Criteria:
  -  Women with metastatic breast cancer at the initial diagnosis
  Exclusion Criteria:
  -  Women needs breast surgery at the time of initial diagnosis (such as bleeding, necrosis, etc)
  -  who have systemic morbidity that do not allows her to be in the trial,
  -  who have synchronous breast cancer at the contralateral breast,
  -  who have a previous cancer history or another primary cancer history and metastasis at the past,
  -  who have palpable lymph node/nodes at the contralateral axilla,
  -  who do not agree to participate the trial

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: ARIA (Atacand Renoprotection In NephropAthy Pt.)

Summary: To determine the effective dose of candesartan cilexetil for reduction of urinary protein excretion in hypertensive patients with non-diabetic chronic kidney disease with baseline urinary protein/creatinine ratio between 500mg/g and 5000mg/g, by assessing the change in urinary protein/creatinine ratio from baseline to the end of 28-week treatment


Eligibility: Inclusion Criteria:
  -  hypertension; a)135mmHg < Systolic Blood Pressure <180mmHg and/or 85 mmHg < Diastolic Blood Pressure <100 mmHg. or b) The subject has been treated with antihypertensive medication
  -  proteinuria (urinary protein/creatinine ratio between 500 mg/g and 5000 mg/g)
  Exclusion Criteria:
  -  Current serum-creatinine > 265 mmol/L (>3 mg/dL).
  -  Current serum-potassium > 5.5 mmol/L
  -  Known hypersensitivity to angiotensin (AT)1-receptor blocker

Relevance to patient case: not relevant