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: Pilot Study of the QI Device for Monitoring of Patients With Congestive Heart Failure

Summary: The present study proposes to utilize a novel, wearable device, QI Device, which has multiple sensors embedded in a "wrist-watch" in order to explore its monitoring capabilities in individuals with congestive heart failure.

Detailed description: The QI Device is a self-contained, reusable, rechargeable, battery-powered, wrist-watch that simultaneously tracks and records a number of physiological health related parameters such as heart rate, blood pressure, respiratory rate, temperature, and motion/position. One advantage of this device over current home diagnostic systems is the capability for longitudinal monitoring.

Eligibility: Inclusion Criteria:
  -  Adults over age 18
  -  Own, and comfortable using, a home computer with internet access (Phase 2 only)
  -  Acute hospitalization with a primary diagnosis of acute decompensated heart failure (ADHF) diagnosed on the basis of all of the following:
  1. Symptoms:
  -  Onset or worsening of dyspnea within the past 2 weeks
  2. Physical exam (at least 1 present):
  -  Rales/ Crackles on auscultation
  -  Elevated JVP > 10 cmH2O
  -  Weight gain
  -  LE edema
  3. Diagnostic imaging/ labs (at least 1 present):
  -  Evidence of pulmonary congestion or edema on chest X-ray/ chest CT
  -  Elevated BNP or NT-pro-BNP (age-adjusted)
  Exclusion Criteria:
  -  Psychological or social situation that would make the study difficult for the patient
  -  Inability to consent
  -  Chronic atrial fibrillation or other dysrhythmia with a high (>10%) burden of ectopic beats.
  -  Pregnant women
  -  Pneumonia - currently, or within the past 30 days
  -  Non-cardiogenic pulmonary edema (e.g. ARDS)
  -  Interstitial lung disease
  -  End-stage renal disease and on Hemodialysis

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 Multi-Center Study of Lapatinib in Patients With Trastuzumab-refractory Metastatic Breast Cancer

Summary: Evaluating the Efficacy of Lapatinib in Combination With Chemotherapy in Patients With Trastuzumab-refractory Metastatic HER2-positive Breast Cancer.

Detailed description: Some studies has demonstrated that even in trastuzumab pretreated patients with HER-2 positive breast cancer, might benefit from the treatment of trastuzumab. However, there is small benefit for some patients having short disease-free survival after adjuvant trastuzumab or short progression-free survival after first-line trastuzumab-based therapy. In clinical practice, the investigators also found it is fact. And the investigators have a scientific rationale for clinical testing of lapatinib plus chemotherapy in patients with trastuzumab-refractory, metastatic HER2-positive breast cancer.

Eligibility: Inclusion Criteria:
  -  Metastatic breast cancer
  -  Eastern Cooperative Oncology Group (ECOG) 0 or 1
  -  HER2-expressing primary or metastatic tumor
  -  Recurrence within 1 year completing adjuvant trastuzumab OR rapid progress following first-line trastuzumab-based care.
  -  Measurable disease with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  -  Normal organ function, including bone marrow function, renal function, liver function, and cardiac function
  -  Signed and dated an informed consent form
  -  Life expectancy of at least 12 weeks
  Exclusion Criteria:
  -  Pregnant or breast feeding
  -  left ventricular ejection fraction (LVEF) < 45% by echocardiogram
  -  Disease-free interval (DFI) less than 12 months
  -  Uncontrolled medical problems
  -  Any previous malignancy exceptions for carcinoma of the cervix, squamous carcinoma of the skin, or basal cell carcinoma of the skin
  -  Patients were unable or unwilling to comply with program requirements

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: Pilot Study of the CoVa™ Monitoring of Patients With Congestive Heart Failure

Summary: The purpose of this study is to obtain observational data allowing for the preliminary assessment of the utility of a noninvasive physiologic monitor for monitoring of patients with congestive heart failure.

Detailed description: The study proposes to utilize the CoVa™ Monitoring System, a novel body-worn sensor that remotely monitors thoracic fluid, heart rate, heart rate variability, respiration rate, skin temperature, posture, and, using transmitted waveforms, stroke volume and cardiac output to evaluate the system's monitoring capabilities in individuals recently hospitalized for congestive heart failure. The data acquired through this study will play a critical roll in developing future interventional studies that will allow patients with HF to potentially receive better and more timely treatment in the home setting, decreasing hospitalizations and improving quality of life.

Eligibility: Inclusion Criteria:
  -  Adults over age 18
  -  Have wireless internet access within their homes.
  -  Acute hospitalization with a primary diagnosis of acute decompensated heart failure (ADHF) diagnosed on the basis of all of the following:
  1. Symptoms:
  -  Onset or worsening of dyspnea within the past 2 weeks
  2. Physical exam (at least 1 present):
  -  Rales/ Crackles on auscultation
  -  Elevated JVP > 8 cmH2O
  -  Weight gain
  -  LE edema
  3. Diagnostic imaging/ labs (at least 1 present):
  -  Evidence of pulmonary congestion or edema on chest X-ray/ chest CT
  -  Elevated NT-pro-BNP (age-adjusted) (>1000)
  -  Patients of particular interest will be those who already have a Medtronic Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy device with the OptiVol feature that tracks transthoracic impedance.
  Exclusion Criteria:
  -  Allergy to ECG electrodes
  -  Psychological or social situation that would make the study difficult for the patient
  -  Inability to consent
  -  Pregnant women
  -  Pneumonia - currently, or within the past 30 days
  -  Non-cardiogenic pulmonary edema (e.g. ARDS)
  -  Interstitial lung disease
  -  End-stage renal disease and on hemodialysis
  -  For any reason unable to wear or place the CoVa™ device, e.g. pectus excavatum, fragile skin, severe arthritis.

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 Tumor Glucose Metabolism Before and After Artificial Nutrition

Summary: Evaluate the feasability to determine the difference of tumoral metabolism before and after artificial nutrition.

Detailed description: Evaluation of the feasability to determine the difference of tumoral metabolism before and after artificial nutrition. This activity will be measured with TEP/TDM 18F-FDG

Eligibility: Inclusion Criteria:
  -  VADS cancer or oesophageal cancer
  -  Evaluation by 18F-FDG PET
  -  denutrition with weight loss of 5%
  -  Artificial nutrition
  -  ECOG<2
  Exclusion Criteria:
  -  Treatment by chemotherapy, surgery unless 2 months
  -  Treatment by radiotherapy unless 4 months
  -  Capillar glycemia >12mmol/l during the PET

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: Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer

Summary: Whether the patients with low grade ductal carcinoma in situ breast cancer should accept radiationtherapy is uncertain.Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.The clinical trial is conducting to find out the effectiveness of radiation therapy during surgery in treating women who have undergone breast-conversing surgery for low grade ductal carcinoma in situ breast cancer.

Detailed description: Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.The clinical trial is conducting to find out the effectiveness of radiation therapy during surgery in treating women who have undergone breast-conversing surgery for low grade ductal carcinoma in situ breast cancer.

Eligibility: Inclusion Criteria:
  -  Tumor diameter < 5 cm
  -  Low grade ductal carcinoma in situ
  -  Candidate for breast-conserving surgery
  -  Must have undergone lumpectomy with negative margins or minimal margin involvement
  -  Currently undergoing re-excision of the biopsy cavity and/or sentinel lymph node biopsy or axillary lymph node dissection
  -  No evidence of metastatic disease
  -  Informed consent
  Exclusion Criteria:
  -  No informed consent
  -  Tumor size > 5 cm
  -  Intermediate or high grade ductal carcinoma in situ
  -  Invasive carcinoma
  -  No indication for a boost

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: Cardiac Toxicity in Medical Treatment of Breast Cancer

Summary: This study will describe the epidemiology including prognosis of heart failure related to treatment with anthracycline and trastuzumab for breast cancer.
  In a prospective study Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer patients scheduled for trastuzumab treatment at Odense University Hospital, will be offered advanced echocardiographic examination, test of bio-markers and genetic markers for the purpose of investigating if early identification of patients in particular risk of developing heart failure is feasible.


Eligibility: Inclusion Criteria:
  -  Diagnosis of HER2 positive breast cancer
  -  Adjuvant treatment with trastuzumab
  Exclusion Criteria:
  -  Left ventricle ejection fraction (LVEF) <50%
  -  Chronic or persistent atrial fibrillation
  -  History of moderate or severe valvular heart 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 to Evaluate the Safety and Efficacy of Everolimus, in Subjects With PIK3CA Amplification, PTEN Loss and PIK3CA Mutation Refractory Solid Tumors

Summary: This study is a single-arm, phase II study of everolimus in patients with PTEN loss ,PIK3CA mutation and PIK3CA amplification Refractory Solid Tumors .
  Everolimus 10 mg will be administered orally qd daily.
  To investigate the efficacy and safety of everolimus in patients with PTEN loss ,PIK3CA mutantion and PIK3CA amplification Refractory Solid Tumors.


Eligibility: Inclusion Criteria:
  1. Provision of fully informed consent prior to any study specific procedures.
  2. Patients must be ≥20 years of age.
  3. PIK3CA amplification, PTEN loss and PIK3CA mutation Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
  4. ECOG performance status 0-2.
  5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
  6. Adequate Organ Function Laboratory Values
  -  Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 75 x 109/L
  -  bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
  -  creatinine ≤1.5 x UNL
  7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
  8. Adequate heart function.
  Exclusion Criteria:
  1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
  2. Has known active central nervous system (CNS) metastases.
  3. Has an active infection requiring systemic therapy.
  4. Pregnancy or breast feeding
  5. Patients with cardiac problem.
  6. KRAS mutation (codon 12 or 13) or BRAF mutation (V600)
  7. Any previous treatment with everolimus

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: HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA）for Breast Cancer

Summary: The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA）for breast cancer.

Detailed description: By enrolling patients with breast cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA）for breast cancer.

Eligibility: Inclusion Criteria:
  1. Age:18-80
  2. Karnofsky performance status >60
  3. Diagnosis of breast cancer based on histology or the current accepted radiological measures.
  4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
  5. Will receive interventional therapy
  6. Life expectancy: Greater than 3 months
  7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
  8. Ability to understand the study protocol and a willingness to sign a written informed consent document
  Exclusion Criteria:
  1. Patients with other primary tumor except breast cancer
  2. History of coagulation disorders or anemia

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: HuMax-IL8 (Interleukin8) in Patients With Advanced Malignant Solid Tumors

Summary: A phase Ib, dose escalation, multiple dose trial with HuMax-IL8 in patients with metastatic or unresectable, locally advanced malignant solid tumors.

Detailed description: All human subjects with a diagnosis of incurable solid tumors are eligible for the dose-escalation phase of this study. This study consists of two phases, the dose-escalation phase and the expansion phase. Subjects will be treated with the study treatment until any off-treatment criteria are met. The safety and efficacy will be assessed until the end of treatment or for a maximum of 52 weeks. In addition, a separate visit will be performed at the time of disease progression if the patient has a progression between end of treatment and 52 weeks. The patients will be followed up for overall survival until the study closure. The study will be closed when all enrolled patients have been followed up for at least 52 weeks or have died.

Eligibility: Inclusion Criteria:
  -  Subjects must have metastatic or unresectable locally advanced malignant solid tumor.
  -  Patients may have measurable or non-measurable but evaluable disease.
  -  Patients with surgically resected metastatic disease at high risk of relapse are also eligible.
  -  Patients must have completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic disease, or not be candidates for therapy of proven efficacy for their disease.
  -  Patients must have recovered (grade 1 or baseline) from any clinically significant toxicity associated with prior therapy
  -  Age ≥ 18 years. .
  -  ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1 (Karnofsky ≥ 70%).
  -  Patients must have normal organ and hematologic function therapy
  -  Patients must have baseline pulse oximetry > 90% on room air
  Exclusion Criteria:
  -  Pregnant women or women presently breast-feeding
  -  Concurrent treatment for cancer
  -  Chronic hepatitis B or C infection.
  -  Any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment.
  -  Significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
  -  Active autoimmune diseases requiring treatment or a history of autoimmune disease.
  -  Concurrent use of systemic steroids
  -  Patients who are receiving any other investigational agents
  -  Patients with untreated central nervous system metastases or local treatment of brain metastases
  -  History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agent used in study.
  -  Serious or uncontrolled intercurrent illness
  -  HIV-positive patients are ineligible
  -  Patients unwilling to use adequate contraception
  Other protocol defined inclusion/exclusion criteria could 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: Acute and Long-term Cardiovascular Toxicity After Modern Radiotherapy for Breast Cancer

Summary: In Europe, breast cancer is by far the most common form of cancer diagnosed in women today, accounting for 29% of all cases. The 5-year survival rate is approximately 90%. Surgery is usually combined with radiotherapy (RT), anthracyclines, aromatase inhibitors and/or trastuzumab (Herceptin) which all have improved the life expectancy and survival in breast cancer patients.
  Unfortunately, RT is associated with a broad spectrum of cardiovascular diseases, which includes coronary artery disease, valvular dysfunction, congestive heart failure and stroke, and is the most common non-malignancy cause of death. During the last two decades, RT regimens for breast cancer have changed and the doses of radiation to which the heart is exposed are now potentially lower due to new and improved RT techniques. However, there are no data on whether these new regimes decrease the risk of cardiovascular disease.
  In this study the incidence and prevalence of cardiovascular diseases will be estimated 8 and 15 years after both conventional and laser assisted breath controlled RT, and compared with cardiovascular diseases in the general female population. A further aim is to evaluate signs and prevalence of acute cardiotoxicity from RT with the use of cardiac magnetic resonance imaging, coronary fractional flow reserve, ECG and inflammatory and cardiac biomarkers and to investigate whether these signs can predict later cardiovascular disease. The importance of traditional cardiovascular risk factors (age, hypertension, hypercholesterolemia, smoking habits and physical activity, as registered before RT) will also be evaluated.

Detailed description: The study is an observational study. In 2007-2012 conventional RT was part of the common treatment regime for breast cancer, but has recently been replaced by laser assisted breath controlled RT. Thus, two cohorts of breast cancer patients treated with different modes of RT will be followed for the development of cardiovascular disease for the subsequent 15 years.

Eligibility: Inclusion Criteria:
  -  diagnosis of breast cancer
  -  expected life-expectancy above 10 years
  Exclusion Criteria:
  -  Not willing to participate

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 Predictive Value of Coexisting TMPRSS2-ERG Gene Fusion and PTEN Deletion in Prostate Cancer Patients With Biochemical Failure Status Post Salvage or Radical Radiation Therapy

Summary: The objective of the study is to evaluate the predictive value of TMPRSS2-ERG gene fusion and PTEN in patients with high risk prostate cancer treated with first line LHRH agonist after biochemical failure.

Detailed description: The objective of the study is to evaluate the predictive value of TMPRSS2-ERG gene fusion and PTEN in patients with high risk prostate cancer treated with first line LHRH agonist after biochemical failure.
  Patients in this study will be treated with standard hormonal treatment. Patients will remain on treatment regardless of rising PSA. PSA, other systemic therapy maybe added and the patients with oligometastasis could be treated with radiation therapy; this would be at the discretion of the treating oncologist.
  The primary endpoint of this study is to determine the predictive value of TMPRSS2-ERG gene fusion and PTEN in hormonal refractory free survival and clinical progression rate in three years. The secondary endpoints are to evaluate the relation between Gleason score and TMPRSS2-ERG gene fusion and PTEN independently and together, the relation between T stage and TMPRSS2-ERG gene fusion and PTEN independently and together, and to determine the association of these markers with overall survival.

Eligibility: Inclusion Criteria:
  -  T3a +
  -  PSA > 20
  -  Gleason 8 or higher
  -  Karnofsky performance status ≥ 70.
  -  Signed study-specific informed consent
  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: Walking Affecting Immunology and Quality of Life of Breast Cancer Patients

Summary: Breast cancer is the leading cancer in women worldwide. The incidence of breast cancer is increasing probably due to the prolonged life expectancy and a variety of environmental factors. Fortunately, breast cancer outcome and survival are improving due to early detection and new treatment modalities. After making first strides against breast cancer, i.e. undergoing ablation surgery, most breast cancer survivors still have to go through a series of chemotherapy, which could prolong their survival but almost inevitably downgrade their quality of life due to grueling side effects, such as lack of energy and vulnerability to infection. Numerous medical interventions have been tried by healthcare providers to alleviate these side effects, but some of them are expensive and therefore become another burden for the cancer-afflicted patients. Previous studies have already indicated that exercise generated long-term benefits to breast cancer survivors, including improved physical functions, elevated maximal oxygen intake, decreases in lethargic symptom, increase in both immune function and quality of life. Among a variety of exercises, walking is the least costly, easy-to-follow type. Through a simple, predesigned walking regimen, the investigators expected that the breast cancer patients undergoing chemotherapy could cost-effectively reap some benefit either physically or psychologically.
  Cluster of differentiation 3 (CD3+), presenting at all stages of T-cell development, is a useful maker to identify T-cells. (Cluster of differentiation 4)CD4+ T cells, also known as T helper cells, play an assistant role in the immunologic process, such as maturation of B cells, activations of macrophages or cytotoxic T cells. Cluster of differentiation 8 (CD8+) T cells, known as cytotoxic T cells, responsible for destroying virus-infected cells and tumor cells. Generally, the counts of CD3+ T cells, CD4+ T cells and CD8+ T cells could be a reflection of immune system health. Short-Form 36(SF-36), a patient-reported survey, is a widely adopted tool to evaluate patient's individual health status. By means of serial blood sample collections and the delivery of SF-36 survey, this study aimed to objectively and quantitatively evaluate the effects of aerobic walking on the breast cancer patients undergoing chemotherapy.


Eligibility: Inclusion Criteria:
  1. Stage I-II breast cancer
  2. Have undergone ablative surgery
  3. Going to receive chemotherapy
  Exclusion Criteria:
  -  Difficulty walking

Relevance to patient case: not relevant