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: High Dose Vit D Musculoskeletal Symptoms & Bone Density in Anastrozole-Treated Breast Cancer With Marginal Vit D Status

Summary: The purpose of this study is to determine whether Vitamin D supplementation reduces the symptoms of muscle stiffness and joint tenderness that some patients may develop after starting therapy with Anastrozole for breast cancer.

Detailed description: This is a pilot, double-blind, randomized, placebo-controlled study with the following aims:
  -  To compare the effects of high dose vitamin D versus standard dose vitamin D on musculoskeletal pain in breast cancer patients receiving anastrozole when vitamin D levels are in the insufficient but not deficient range (10 to 29 ng/ml).
  -  To evaluate the prevalence of vitamin D insufficiency/deficiency in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms versus those who are asymptomatic.
  -  To establish correlations between levels of vitamin D, the levels of PTH, the degree of bone loss and the severity of musculoskeletal symptoms.
  -  To evaluate the effect of standard dose versus high dose Vitamin D replacement on bone density in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms.

Eligibility: Inclusion Criteria
  -  Women with a diagnosis of hormone receptor positive invasive breast cancer (Stage I-IIIB) or ductal carcinoma in situ (DCIS)
  -  Postmenopausal status
  -  Completed at least 8 weeks of anastrozole as adjuvant therapy prior to study entry
  -  Completed systemic chemotherapy and radiation treatments when indicated
  -  Serum Calcium ≤ 10.3 mg/dL
  -  Patients with marginal 25 OH Vitamin D level (between 10 and 29 ng/ml) will be in the Randomized Group or Low 25 OH Vitamin D level (less than 10 ng/ml) will be in Observational Group
  -  24-hour urine Calcium excretion ≤ 250 mg/g (calculated by dividing 24 hour calcium by 24 hour creatinine)
  -  A history of generalized musculoskeletal pain with or without localized regions or discomfort that has developed or worsened since starting adjuvant aromatase inhibitor therapy
  Exclusion Criteria
  -  Known metastatic disease
  -  History of kidney stones
  -  History of active primary hyperparathyroidism
  -  History of Paget's disease of the bone
  -  History of severe arthritis, rheumatoid arthritis, or severe neuropathy
  -  Normal 25 OH Vitamin D level (≥ 30 ng/ml)
  -  Medical or psychiatric condition which may preclude protocol compliance

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: Diuretic Efficacy of Dexamethasone in Heart Failure

Summary: The purpose of this study is to determine whether glucocorticoids have potent diuretic effects in patients with congestive heart failure.

Detailed description: Glucocorticoids are known to have pronounced physiological effects in the kidney. Conventional teaching dictates that it should be used with caution in patients with congestive heart failure due to its fluid and sodium retention effects. Surprisingly, despite the widespread prevalence of this belief within the medical community, there are few data to support it. In fact, several small animal studies have documented its striking diuretic effects due to increased renal plasma flow and glomerular filtration rate without changes in the glomerular filtration fraction. We design this study to determine whether glucocorticoids have a potent diuretic effect in patients with heart failure.

Eligibility: Inclusion Criteria:
  -  Congestive heart failure patients due to any cause
  -  Patients with normal cortical function
  -  Congestive heart failure patients who are on diuretic therapy
  -  Clinically stable and body weight maintained the same for at least 3 days without signs of fluid retention
  Exclusion Criteria:
  -  Patient refusal
  -  Signs of infection

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: Young Women's Breast Cancer Research Program

Summary: The purpose of this study is to identify novel genetic factors which distinguish breast cancer in younger women compared to older women. By identifying these novel genetic factors we believe more specific therapies can be developed and breast cancer may be prevented among women with an increased cancer risk. A woman does not have to live in St. Louis to participate.

Detailed description: Breast cancer takes its greatest toll on younger women, as it is the leading category of cancer deaths for women 20-39 years of age. Sadly, survival rates are lowest among women diagnosed at a young age. This impact is most significant among African-American women who have the highest incidence and mortality rate among women less than 45 years of age. The goal of our program is to identify the genetic factors which distinguish breast cancer in younger women compared to older women.
  Women who were diagnosed with invasive breast cancer 40 years of age or younger are invited to participate. The age at diagnosis is used to determine eligibility, not a woman's current age. Women who have undergone genetic testing of the BRCA1, BRCA2, p53, pTEN, e-cadherin, or LKB1 genes are eligible to participate. Young women with breast cancer are asked to: sign a consent form, submit a sample of blood, release their cancer related records, and answer some family history questions.
  We will use a family based case control approach in our analysis. As such, if a woman's parents are living, they will be invited to participate as a "comparison" group. The parents are asked to: sign a consent form, submit a sample of blood, and release any cancer records.
  A woman does not have to live in St. Louis to participate. All study related materials can be mailed directly to the young woman or her parents. There is no expense to the family. All materials are kept strictly confidential and participation is completely voluntary.

Eligibility: Inclusion Criteria:
  -  Women diagnosed with invasive breast cancer 40 years of age or younger. If their parents are living, the parents are also invited to participate, regardless of their history of cancer.
  Exclusion Criteria:
  -  Women diagnosed with in-situ breast cancer.

Relevance to patient case: definitely relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer

Summary: To examine nipple aspirate fluid for secretions that may be identified as a high risk indicator for development of breast cancer, and compare those to serum analysis.

Detailed description: To examine nipple aspirate fluid analysis in lactating women for local concentration of estrogen, prolactin, glucocorticoids, insulin, parity, prior lactation and age. NAF secretors have been reported to have modest increase in breast cancer risk compared to non-secretors . Estrogen levels have been found to be markedly higher in NAF samples than in the serum collected from the same women. Estradiol and estrone concentrations in premenopausal women are 10x and 20x greater in NAF samples than in serum and 50x and 35x greater in post-menopausal women not on HRT. It has been suggested that the disparity between serum and NAF levels may be due to local estrogen production via aromatase and sulfatase.

Eligibility: Inclusion Criteria:
  -  women with high a high risk of breast cancer
  -  Older than 18
  Exclusion Criteria:
  -  anticoagulants
  -  marked breast tenderness
  -  pregnant or within twelve months of breast feeding/childbirth

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: Protocol for Women at Increased Risk of Developing Breast Cancer

Summary: To assess the effects of twelve months of celecoxib administration by evaluating breast tissue needle aspirations, to determine if cell growth can be slowed.

Detailed description: A blind randomized study of celecoxib in women at high risk of developing breast cancer. Subjects are to take twelve months of drug/placebo. At baseline and after twelve months subjects will have a random periareolar fine needle breast aspiration that will be assessed for epithelial cell growth and other markers of risk. Baseline and twelve month serum samples will also be assessed for hormones and growth factors which may be associated with breast cancer risk. Mammograms at baseline and twelve months will also be assessed for breast density changes.

Eligibility: Inclusion Criteria:
  -  women who have a high risk of breast cancer
  -  older than 18 years
  Exclusion Criteria:
  -  anticoagulants
  -  marked breast tenderness
  -  pregnant or within twelve months of breast feeding/childbirth

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: Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial

Summary: This trial will look at the effectiveness and patient acceptance of ultrafiltration therapy in an outpatient setting.
  The purpose of this study is to determine if ambulatory patients who suffer from heart failure and hypervolemia can be safely and effectively treated in an outpatient infusion clinic. The results from this trial will be useful in planning a larger, randomized trial comparing usual care and ultrafiltration for this patient population in similar ambulatory settings.

Detailed description: This is a pilot study to assess the feasibility, effectiveness, safety and patient acceptance of ultrafiltration in ambulatory patients with heart failure and hypervolemia. The results will be useful in planning a larger clinical trial.

Eligibility: Inclusion Criteria:
  -  Patients will be recruited from the cardiology clinic at Hennepin County Medical Center. Patients are eligible for the study if they are:
  1. Older than 18
  2. Not pregnant
  3. Have heart failure with worsening hypervolemia despite oral diuretics
  4. Have at least two of the following signs or symptoms of hypervolemia: JVD, edema >1+, rales pulmonary edema on chest x-ray, orthopnea or PND
  5. Not more than 10 kg above their usual baseline weight
  6. Have, in the opinion of the treating physician, a need for a minimum of 2 liters of volume removal
  Exclusion Criteria:
  1. Systolic blood pressure < 90 mmHg
  2. Serum creatinine > 3.0 mg/dL
  3. Hematocrit >45 %
  4. Uncontrolled arrhythmias
  5. Need for hospitalization
  6. Require renal replacement therapy
  7. Contraindication to anticoagulation with heparin
  8. Poor venous access.

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 Trial of Paclitaxel and Bevacizumab vs. Gemcitabine, Paclitaxel, and Bevacizumab in Advanced Breast Cancer

Summary: This study will compare the cancer response to both treatments for locally advanced or metastatic breast cancer


Eligibility: Inclusion Criteria:
  -  Females diagnosed with breast cancer and the cancer has spread to distant areas of the breast or organs.
  -  Must be able to measure the disease by specific medical parameters
  -  May have received breast cancer treatment in the early stage of the disease
  -  May be restricted in physically strenuous activity but able to carry out light work.
  -  Must have adequate organ function as seen in blood test results.
  Exclusion
  Criteria:
  -  Cancer that has spread to the brain.
  -  Unstable heart problems
  -  Unstable high blood pressure.
  -  Breast cancer treatment after the disease has considered to spread to other areas or organs.
  -  Unable to agree with the requirements of the study

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

Clinical trial: Genetic Counseling for Menopausal Therapy Decision-Making for Women at Increased Risk for Breast Cancer

Summary: The purpose of this study is to determine the effects of a personalized menopausal therapy risk assessment and genetic counseling intervention on knowledge, risk perception, and decision-making in healthy women at increased risk for breast cancer.

Detailed description: Women with a family history of breast cancer have several menopausal therapy options, including tamoxifen, hormone therapy, alternative medications, or no treatment. This complex decision should be based on each woman’s risk to develop breast cancer, menopausal symptoms, preferences, and risks for other conditions. Current models in use for menopausal therapy counseling do not include pedigree analysis, personalized risk assessment or genetic testing in this process. The purpose of this multi-center study is to determine the effects of a personalized risk assessment and genetic counseling intervention on knowledge, risk perception, and decision-making in a group of healthy women who had a first-degree relative with breast cancer. Intervention participants will be given a personalized risk assessment for breast cancer, heart disease, osteoporosis, and uterine cancer based on family history and personal health data.

Eligibility: Inclusion Criteria:
  -  at least one first degree relative with breast cancer
  -  age 40 or older
  Exclusion Criteria:
  -  currently taking a menopausal therapy
  -  previous cancer diagnosis (except basal cell carcinoma)
  -  previous diagnosis of atypical hyperplasia
  -  previous diagnosis of lobular carcinoma in situ (LCIS)
  -  known carrier of a BRCA1 or BRCA2 mutation
  -  personal history of heart disease
  -  >10% risk of carrying a BRCA1 or BRCA2 mutation

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: Treatment of Severe Heart Failure by Ultrafiltration

Summary: Patients with severe congestive heart failure show increased fluid body content which is often resistant to conventional diuretic therapy. Therefore, chronic heart failure patients have frequent access to the emergency room and hospital for hemodynamic instability. Ultrafiltration is a simple renal replacement therapy which reduces fluid overload. The purpose of this study is to determine whether periodic ultrafiltration sessions maintain patients in stable clinical condition and reduce hospitalisations as well as access to emergency heart failure treatment.

Detailed description: Patients with severe heart failure (New York Heart Association [NYHA] III-IV) and fluid overload will be randomized to ultrafiltration (UF group) or conventional medical treatment (Control group). Patients follow-up at least monthly visit for one year. Ultrafiltration will be repeated during follow-up in case of body weight gain due to fluid accumulation. Ultrafiltration will be performed during short term hospitalization.

Eligibility: Inclusion Criteria:
  -  Severe heart failure (NYHA III-IV) with fluid overload
  -  Ejection fraction < 40%
  -  Estimated fluid overload > 4 kg
  Exclusion Criteria:
  -  Severe renal insufficiency
  -  Acute pulmonary edema and/or cardiogenic shock

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: Therapy With Verapamil or Carvedilol in Chronic Heart Failure

Summary: The aim of this study is to compare the effect of treatment with verapamil or carvedilol on long-term outcomes in stable, chronic heart failure secondary to non-ischemic cardiomyopathy.

Detailed description: Heart failure, irrespective of its etiology may be viewed as a progressive disorder initiated by a different events and sustained by a multifaceted pathophysiological mechanisms. Regardless of the nature of the initiating events and optimized therapy used, loss of functioning cardiac myocytes developed and the disease progressed. One potential explanation for such progression is that not all pathological mechanisms underlying the disease are antagonized enough by currently used therapeutic strategy. Accordingly, impaired myocardial perfusion secondary to microvascular dysfunction has been postulated to play a major role in the progression of heart failure despite standard therapy for heart failure. It has been hypothesized that diffuse subendocardial ischemia due to altered coronary physiology may contribute to the global cardiac dysfunction seen in heart failure patients. Accordingly, coronary endothelial dysfunction at the microvascular and epicardial level in patients with acute-onset idiopathic dilated cardiomyopathy and chronic congestive heart failure has been reported. Thus, taking all mentioned above into account, the improvement in endothelial function and diminishing of subendocardial ischemia with calcium antagonists may be promising in terms of using these drugs for therapy of patients with stable chronic heart failure. The previous randomized study (5) and our long-term pilot study support this point of view.

Eligibility: Inclusion Criteria:
  -  Chronic heart failure (NYHA II and III; LV ejection fraction, ≤ 35%) secondary to non-ischemic cardiomyopathy
  -  Stable condition at least 6 months before enrollment on conventional therapy (beta-blockers, ACE inhibitors and diuretics).
  Exclusion Criteria:
  -  Improvement in clinical status on conventional therapy in out-patients period preceded hospitalization,
  -  Any changes narrowing epicardial coronary arteries in coronary angiography,
  -  Insulin dependent diabetes,
  -  Valvular heart disease (except the relative mitral regurgitation),
  -  Endocrine disease
  -  Significant renal and liver disease
  -  Alcohol abuse
  -  Lack of written 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: Evaluation of Group CBT Programme With Breast Cancer Patients

Summary: The purpose of this study is to examine whether a group CBT intervention is effective in reducing psychological distress in women with primary breast cancer.

Detailed description: The diagnosis and treatment of cancer is associated with high levels of psychological distress, which can be long-term in duration. The end of adjuvant therapy can be a time which patients find anxiety provoking; as concerns of recurrence and how to return to life after treatment often arise at this juncture.
  Cognitive behaviour therapy has demonstrated efficacy in reducing anxiety and depression in people with cancer on a 1:1 basis. The CBT model has been shown to be significantly more beneficial than supportive counselling. Therapy delivered in groups is considered desirable because of its cost effectiveness, and its potential to confer additional benefits in terms of peer support, reduced isolation and modelling of adaptive strategies by other group members.
  No studies have looked at the changes in participants health beliefs and beliefs about their ability to copy (self-efficacy) with stress and tolerance of uncertainty following group CBT and the relationship with psychological distress.
  The aim of this study is to evaluate a GCBT programme intervention against a waiting list control and to examine its effects on health beliefs, self-efficacy, coping, tolerance of uncertainty and psychological distress in women with early diagnosed breast cancer.

Eligibility: Inclusion Criteria:
  -  Female
  -  Primary breast cancer
  -  post adjuvant treatment
  Exclusion Criteria:
  -  Women with metastatic disease
  -  Severe cognitive impairment (will not be able to obtain consent or participant in group intervention)
  -  Inability to complete a questionnaire

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: Randomized Phase II Study of Epirubicin vs Caelyx in Pretreated Metastatic Breast Cancer

Summary: DOXORUBICIN is recognized as one of the most active drugs for breast cancer, but its clinical utility is limited because of a cumulative dose-dependent cardiac myopathy that can lead to potentially fatal congestive heart failure. Caelyx (pegylated liposomal doxorubicin) was designed to reduce the cardiotoxicity of doxorubicin while preserving its antitumor efficacy

Detailed description: To compare the efficacy of pegylated liposomal doxorubicin versus epirubicin as second line chemotherapy in patient with advanced breast cancer

Eligibility: Inclusion Criteria:
  -  Age 18-75 years
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  -  Adequate bone marrow function (Absolute neutrophil count >1000/mm^3, Platelet count>100000/mm^3, Hemoglobin>9gr/mm^3)
  -  Histologically- or cytologically- confirmed breast adenocarcinoma
  -  No prior anthracycline-based chemotherapy as treatment of advanced breast cancer
  -  No prior chemotherapy with ≥ 300mg/m2 doxorubicin or ≥ 540mg/m2 epirubicin as adjuvant setting
  -  At least 4 weeks interval since prior anticancer treatment
  -  Measurable disease as defined by the presence of at least one measurable lesion(except bone metastases, ascites or pleural effusions)
  -  Life expectancy > 3 months
  -  Written informed consent
  Exclusion Criteria:
  -  Pregnancy or nursing
  -  Documented history of congestive heart failure (CHF), serious arrhythmia, or myocardial infarction (within 6 months)
  -  Other invasive malignancy except nonmelanoma skin cancer or acute infection.
  -  Radiation of measurable disease (except brain metastases)
  -  Progressive brain metastases according to clinical or radiological criteria.
  -  Brain metastases without prior radiation therapy

Relevance to patient case: not relevant