araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Diagnostic Study to Identify Sentinel Lymph Nodes in Women With Stage I or Stage II Breast Cancer

Summary: RATIONALE: Diagnostic procedures, such as blue dye or imaging to identify sentinel lymph nodes, may improve the ability to detect the extent of disease and help plan effective surgery for removing breast tumors.
  PURPOSE: Diagnostic trial to study the effectiveness of blue dye and an imaging procedure to identify the sentinel lymph node under the arm in women with stage I or stage II breast cancer.

Detailed description: OBJECTIVES: I. Determine whether the concept of a sentinel lymph node within the axillary nodal basin is valid in staging breast cancer. II. Determine the sensitivity of combined methods of identification of sentinel lymph nodes by patent blue V dye and gamma probe detection in these women.
  OUTLINE: Patients receive patent blue V dye injection peritumorally prior to surgery. Preoperative lymphoscintigraphy is performed using technetium Tc 99 sulfur rhenium colloid injected around the tumor associated with intraoperative gamma probe detection. Nonpalpable tumors receive a localized injection using stereotactic injection techniques. Patients then undergo standard axillary (level I and II) lymph node dissection.
  PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study within 1 year.

Eligibility: DISEASE CHARACTERISTICS: Histologically or cytologically proven stage I or IIA invasive breast cancer T0, T1, or T2 (no greater than 3 cm), N0 Noninflammatory Nonmetastatic No ductal carcinoma in situ Eligible for breast-conserving surgery Hormone receptor status: Positive or negative
  PATIENT CHARACTERISTICS: Age: Any age Sex: Female Menopausal status: Pre- and postmenopausal Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant No allergy or sensitivity to radiopharmaceuticals or patent blue V dye
  PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior neoadjuvant chemotherapy Endocrine therapy: No prior endocrine therapy Radiotherapy: No prior neoadjuvant radiotherapy Surgery: No prior breast surgical biopsy or axillary surgery

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Tamoxifen in Treating Women With Breast Cancer

Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells.
  PURPOSE: Randomized phase III trial to compare the effectiveness of at least 2 years of tamoxifen with that of 5 additional years of tamoxifen in treating women who have breast cancer that has been surgically removed.

Detailed description: OBJECTIVES:
  -  Compare the disease-free and overall survival of women with early breast cancer who are randomized to discontinue adjuvant tamoxifen vs those randomized to continue for at least 5 additional years.
  OUTLINE: This is a randomized study. Patients are stratified for analysis according to duration of tamoxifen given before randomization (2-3 years vs 4-5 years vs 6-7 years vs 8-9 years vs 10 years and over), age (less than 49 vs over 50), and important prognostic factors, including tumor type and grade and nodal and estrogen receptor status. Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients discontinue tamoxifen after at least 2 years of prior treatment.
  -  Arm II: Patients continue treatment with tamoxifen for at least 5 additional years in the absence of unacceptable toxicity or disease progression.
  Patients are followed annually.
  Peer Reviewed and Funded or Endorsed by Cancer Research UK
  PROJECTED ACCRUAL: A total of 8,000-20,000 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed breast carcinoma that has been completely excised
  -  Clinically relapse free
  -  Must have completed at least two years of adjuvant therapy with tamoxifen for early breast cancer AND have no clear indication for or against receiving further tamoxifen
  -  No significant endometrial hyperplasia
  -  No patients with negligibly low risk of breast cancer death
  -  Hormone receptor status:
  -  Any status allowed
  PATIENT CHARACTERISTICS:
  Age:
  -  Not specified
  Sex:
  -  Female
  Menopausal status:
  -  Any status allowed
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  No other life threatening disease
  -  No retinopathy
  -  No psychiatric disorder or other condition that would preclude study compliance
  -  No serious toxicity (e.g., depression) thought to be due to tamoxifen
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  See Disease Characteristics
  Radiotherapy:
  -  Not specified
  Surgery:
  -  See Disease Characteristics
  Other:
  -  Any primary treatment allowed

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Anxiety and Vagal Control of the Heart in Coronary Disease

Summary: To examine the role of reduced vagal control of heart rate in the increased risk of cardiac mortality associated with anxiety in a population with established coronary artery disease (CAD). A second objective is to determine whether the effects of anxiety are independent of the effects of depression.

Detailed description: BACKGROUND:
  Coronary heart disease continues to be the leading cause of death in the United States, despite risk factor reduction and technological advances in treatment options. Prospective studies implicate chronic anxiety as an independent risk factor for fatal coronary heart disease. In particular, anxiety increases the risk of sudden cardiac death substantially.
  DESIGN NARRATIVE:
  Nine hundred and fifty CAD patients were recruited for this study from patients hospitalized for elective cardiac catheterization. Anxiety was measured by the Hospital Anxiety Scale, the Spielberger Trait Anxiety Inventory, and the Crown-Crisp Phobic Anxiety Scale. Symptoms of depression were measured by the Montgomery-Asberg Depression Rating Scale, the Hospital Depression Scale, and the Beck Depression Inventory. Vagal control of heart rate was determined using power spectral analysis to measure two indices of vagal control: baroreceptor-mediated vagal reflex cardiac control, and respiratory sinus arrhythmia. Patients were followed at 6 months, l year, 2 years, and 3 years postcatheterization, and cardiac mortality data were obtained, including non-sudden and sudden cardiac death. The data generated by this study were used to examine the involvement of impaired vagal cardiac control in the risk of fatal coronary heart disease and sudden cardiac death associated with anxiety.
  Specifically, the study examined: (1) the relationship between anxiety and cardiac mortality; (2) the relationship between anxiety and vagal control; (3) the role played by reduced vagal control in mediating anxiety-related risk; and (4) the relationship between depression, vagal control and cardiac risk. Findings of a relationship between anxiety, reduced vagal control and sudden cardiac death would suggest the potential importance of early intervention in cardiac patients with anxiety disorders and would underscore the benefit of aggressive monitoring of arrhythmias in this population, which may ultimately translate to reduced mortality rates.
  The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility: No eligibility criteria

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer

Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 before surgery may block the uptake of estrogen by the tumor cells and prevent metastases. It is not yet known if ICI 182780 is effective in preventing breast cancer metastases.
  PURPOSE: Randomized phase III trial to study the effectiveness of ICI 182780 given before surgery in treating women who have stage I or stage II primary breast cancer.

Detailed description: OBJECTIVES:
  -  Determine the inhibitory effect of ICI 182780 on the development of metastasis, as measured by disease-free survival and overall survival, in women with operable stage I or II primary breast cancer.
  -  Determine toxicity of this regimen in these patients.
  OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and menopausal status (premenopausal vs postmenopausal).
  Patients are randomized to receive either ICI 182780 IM or placebo IM over 2 minutes on day 1. Patients undergo surgery between days 8 and 29.
  Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
  PROJECTED ACCRUAL: A total of 3,656 patients (1,828 per arm) will be accrued for this study within 2 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed stage I or II primary operable breast cancer
  -  Surgery planned within next 1-4 weeks
  -  Hormone receptor status:
  -  Estrogen receptor positive or unknown
  -  No known estrogen receptor negative tumor
  -  Unknown progesterone receptor status eligible
  PATIENT CHARACTERISTICS:
  Age:
  -  Any age
  Sex:
  -  Female
  Menopausal status:
  -  Premenopausal or postmenopausal
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  No bleeding diathesis not compatible with an IM depot injection
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  Not pregnant
  -  Negative pregnancy test
  -  Fertile patients must use effective non-hormonal contraception during and for 2-3 months after study
  -  No other prior or concurrent malignancy except adequately treated basal cell carcinoma of the skin or cancer of the uterine cervix
  -  No psychological, familial, sociological, or geographical condition that would preclude study
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  At least 2 months since prior ICI 182780
  Radiotherapy:
  -  No prior radiotherapy to primary tumor
  Surgery:
  -  See Disease Characteristics
  Other:
  -  No other concurrent preoperative therapy for breast cancer

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Cryosurgery in Treating Women With Breast Lesions

Summary: RATIONALE: Cryosurgery kills cancer cells by freezing them. Cryosurgery followed by lumpectomy or mastectomy may be an effective treatment for breast lesions.
  PURPOSE: Phase I trial to study the effectiveness of cryosurgery in treating women who have breast lesions.

Detailed description: OBJECTIVES:
  -  Determine the feasibility of temperature-monitored, ultrasound-guided cryosurgery in women with highly suspicious breast lesions.
  -  Determine the safety of this procedure in these patients.
  OUTLINE: This is a multicenter study.
  Patients undergo cryoablation of up to two breast lesions. Within 3-21 days, patients undergo lumpectomy or mastectomy.
  Patients are followed at 1, 4, 8, and 12 weeks after lumpectomy or mastectomy.
  PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Highly suspicious breast lesion on prior mammogram and/or ultrasound with confirmation of malignancy on ultrasound-guided core biopsy
  -  Tumor no greater than 2.0 cm in diameter
  -  Eligible for lumpectomy or mastectomy
  -  No superficial breast lesions
  -  No prior open surgical biopsy
  -  Hormone receptor status:
  -  Not specified
  PATIENT CHARACTERISTICS:
  Age:
  -  Any age
  Sex:
  -  Female
  Menopausal status:
  -  Not specified
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  No other illness that would preclude study participation
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Not specified
  Surgery:
  -  See Disease Characteristics
  -  No other surgery that would preclude study participation
  Other:
  -  No other medical treatment that would preclude study participation

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer

Summary: RATIONALE: Telephone counseling by a nutritionist and a personal trainer may improve physical function and quality of life in patients who have early-stage breast cancer or prostate cancer.
  PURPOSE: Randomized clinical trial to compare the effectiveness of a home-based, diet and exercise-based counseling program with that of a standard home-based counseling program in promoting health in patients who have early-stage breast cancer or prostate cancer.

Detailed description: OBJECTIVES:
  -  Compare the efficacy of a diet and exercise-based home-based counseling program versus a standard home-based counseling program for improving physical function at 6 and 12 months for patients with early-stage breast or prostate cancer.
  -  Compare the effects of these home-based programs on diet quality, physical activity, weight status, depression, and quality of life of these patients.
  -  Compare the factors, such as gender, race, and social support, that interact with these home-based programs to predict program efficacy in these patients.
  OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms.
  -  Arm I: Patients receive home-based telephone counseling by a personal nutritionist and a personal trainer.
  -  Arm II: Patients receive home-based standard health telephone counseling in unrelated areas of cancer care (e.g., sun exposure, screening, and falls prevention).
  In both arms, counseling continues every 2 weeks for 6 months.
  Patients are followed at 6 months.
  PROJECTED ACCRUAL: A total of 420 patients (210 per arm) will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of early-stage breast or prostate cancer within the past 18 months
  -  Dietary and physical activity habits and baseline functional status that places patient at risk
  -  Potentially able to increase physical activity and to follow a low-fat, plant-based diet
  -  Hormone receptor status:
  -  Not specified
  PATIENT CHARACTERISTICS:
  Age:
  -  65 and over
  Sex:
  -  Male or female
  Menopausal status:
  -  Not specified
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  Able to speak and write English
  -  No other malignancy within the past 5 years except nonmelanoma skin cancer
  -  No other illness or condition that would preclude adherence to a plant-based diet or exercise
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Not specified
  Surgery:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Glycemic Control Of Carvedilol Versus Metoprolol In Patients With Type II Diabetes Mellitus And Hypertension

Summary: To evaluate the effects of two different antihypertensive medications in the drug class of beta-blockers on control of glucose in Type II diabetic patients with high blood pressure.


Eligibility: Inclusion criteria:
  -  Patients at screening must be insulin producing Type II diabetics (C peptide positive).
  -  Must have a history of mild to moderate hypertension (140-179 systolic; 90-1-9 diastolic).
  -  Must be on stable regimen of ACE (angiotensin converting enzyme) / ARB (angiotensin receptor blocker) treatment alone or in combination with other treatments.
  -  Patient''s laboratory result for HbA1c must be 6.5 - 8.5 (drug treated) or 6.5 - 7.5 (diet alone).
  -  Must be on a stable antidiabetic regimen (drug treated or diet alone).
  Exclusion criteria:
  -  Patients using beta-blocker therapy.

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Effect Of Carvedilol Versus Metoprolol On Glycemic Control In Patients With Type II Diabetes And Hypertension

Summary: Evaluation of the effect of two different antihypertensive treatments on control of glucose in Type II diabetic patients with high blood pressure


Eligibility: Inclusion criteria:
  -  Patients at screening must be insulin producing Type II diabetics (C peptide positive).
  -  Patients must have a history of mild to moderate hypertension (140-179 systolic blood pressure; 90-1-9 diastolic blood pressure)
  -  Patients must be on a stable regimen of ACE (angiotensin converting enzyme) / ARB (angiotensin receptor blocker) treatment alone or in combination with other treatments.
  -  Patients must be on stable antidiabetic regimen (drug treated or diet alone).
  -  Patient''s laboratory result for HbA1c must be 6.5 - 8.5 (drug treated) or 6.5 - 7.5 (diet alone).
  Exclusion criteria:
  -  Patients using beta-blocker therapy.

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Study Evaluating Temsirolimus (CCI-779) In Breast Neoplasms

Summary: To evaluate the preliminary activity and pharmacokinetics of 2 separate doses and schedules of orally administered Temsirolimus (CCI-779) given in combination with daily letrozole, compared to letrozole alone, in the treatment of locally advanced or metastatic breast cancer in postmenopausal women. All patients must be appropriate to receive endocrine therapy as treatment for advanced disease.


Eligibility: Inclusion Criteria:
  -  Postmenopausal women with histologically confirmed, measurable locally advanced disease or metastatic breast.
  -  Must be appropriate to receive endocrine therapy as treatment for advanced disease (chemotherapy; prior adjuvant therapy with antiestrogens other than aromatase inhibitors; prior adjuvant or first-line metastatic therapy with tamoxifen or trastuzumab, are permitted).
  -  Women may either present with de novo advanced or metastatic cancer, or have had tumor progression while receiving adjuvant tamoxifen or at any time after completing adjuvant tamoxifen, or have had tumor progression while receiving first-line metastatic therapy with tamoxifen.
  Exclusion Criteria:
  -  Patients having known central nervous system (CNS) metastases.
  -  Prior therapy with Temsirolimus (CCI-779) or aromatase inhibitors.
  -  Tamoxifen, or other hormonal therapy, in the metastatic or adjuvant setting within 1 week prior to day 1 of treatment on study.

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer

Summary: The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture.


Eligibility: Inclusion Criteria:
  -  Women defined as Postmenopausal
  -  Histologically proven operable invasive breast cancer
  -  Hormone-receptor-positive breast cancer
  Exclusion Criteria:
  -  Clinical evidence of metastatic disease
  -  Bilateral hip fractures or bilateral hip prosthesis
  -  Receiving or received in last 12 months hormonal therapy for breast cancer, bisphosphonate therapy, oestrogens
  -  Malabsorption syndrome

Relevance to patient case: not relevant