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: Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment

Summary: The purpose of this study is to evaluate the use of an oral bisphosphonate (alendronate) in preventing bone loss in postmenopausal women with early breast cancer who are receiving anastrozole therapy, and to determine how long alendronate treatment is needed.


Eligibility: Inclusion Criteria:
  -  Postmenopausal
  -  Adequately diagnosed and treated Stage I-IIIa early breast cancer
  -  Oestrogen receptor and/or progesterone receptor positive breast cancer
  -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
  -  Hormone replacement therapy (HRT) must be discontinued at least 2 weeks prior to registration
  -  Any prior tamoxifen taken for a total of 8 weeks or less
  -  Any prior anastrozole taken for a total of 4 weeks or less
  -  Anastrozole is clinically indicated to be the best adjuvant strategy
  -  Signed written informed consent
  Exclusion Criteria:
  -  Clinical or radiological evidence of distant spread of disease
  -  Prior treatment with bisphosphonates within the past 12 months
  -  Prior treatment with continuous systemic corticosteroids within the past 12 months
  -  Prior use of parathyroid hormone for more than 1 week
  -  Prior use of systemic sodium fluoride for > 3 months during the past 2 years
  -  Currently treated with any drugs known to affect the skeleton
  -  Abnormal renal function (serum creatinine greater than or equal to 265.2 mmol/L)
  -  History of diseases with influence on bone metabolism. Patients with lactose intolerance are also excluded
  -  Delayed oesophageal emptying such as stricture or achalasia
  -  Hypersensitivity to alendronate or anastrozole
  -  Previous or concomitant malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix
  -  AST/SGOT and/or ALT/SGPT > 3 x ULN in combination with other laboratory and clinical abnormalities indicating liver insufficiency
  -  Fracture due to minimal trauma, demonstrated radiologically

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: STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing Pilot)

Summary: This is a randomized study comparing the use of Anastrozole before and continuing during radiotherapy for breast cancer compared to the use of anastrozole after irradiation.

Detailed description: Adjuvant radiotherapy is well established as the primary modality to enhance local control in breast cancer. The use of adjuvant hormone therapy such as tamoxifen has shown to improve local control to a relatively minor amount on its own and does enhance local control of adjuvant radiotherapy. There is however, conflicting in vitro and clinical data regarding the effects of different sequences on tamoxifen and radiotherapy in terms of both local control and enhancement of radiotherapy toxicities.
  Aromatase inhibitors such as anastrazole are establishing themselves as a class of drug superior to tamoxifen for the control of estrogen dependent breast cancers and overall are better tolerated with the exception of greater bone loss.
  As the key question is whether the sequencing of the aromatase inhibitor anastrozole alters local control by acting as an enhancer of the radiation breast cancer cell kill, it is therefore the aim of this study to compare 3 months of anastrozole prior to radiotherapy versus 3 months of anastrozole after radiotherapy with a specific objective of reducing the baseline ratio of in- field radiotherapy failure from 6% to 3%.This pilot study is preliminary to a planned long term study to investigate local failure.
  For the pilot a period of 6 months with all contributing centres open will provide a good test of recruitment matching estimates. 100 patients will provide a good sample to compare to the 270 tamoxifen treated women in the breast boost study for quality of life. It will also provide a 95% CI on the proportion of complying women in the order of ± 5% if 85 to 90 % of women comply.

Eligibility: Inclusion Criteria:
  -  Age 18 or more years. No upper limit.
  -  Post total mastectomy or lumpectomy. All planned surgery complete.
  -  Margins clear (no tumour contacting the inked margin)
  -  Tumour oestrogen or progesterone receptor positive
  -  Planned dose to irradiated volumes at least the biological equivalent of 45 Gy in 25 fractions or more.
  -  ECOG 0-2
  -  Patients post menopausal using same criteria as ATAC study.
  -  Written informed consent
  Exclusion Criteria:
  -  Previous radiotherapy to the area to be treated.
  -  Previous invasive malignancy within 5 years of current breast cancer diagnosis with the exception of cervix in-situ or skin cancer other than melanoma.
  -  Patients with clinical evidence of metastatic disease.
  -  Previous hormonal breast therapy.
  -  Ongoing hormone replacement therapy.

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: Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer

Summary: To determine if hypofractionated radiotherapy to the whole breast (4,250 cGy/16 fractions over 22 days) is equally effective to standard fractionated radiotherapy (5,000 cGy/25 fractions over 35 days) in women with node negative breast cancer who have undergone lumpectomy.
  The primary outcome is local breast recurrence and secondary outcomes include morbidity and cost effectiveness.


Eligibility: Inclusion Criteria:
  1. The female patient has a histological diagnosis of invasive carcinoma of the breast, and no evidence of metastatic disease.
  2. Has had a lumpectomy (including segmental resection and partial mastectomy), that is, surgical excision of the tumour with a rim of normal tissue.
  3. Patient has not had an axillary dissection, OR for patients who have had an axillary dissection, all nodes are negative for metastatic disease.
  Exclusion Criteria:
  1. Tumour greater than 5 cm in greatest diameter on pathological examination.
  2. The presence of invasive or intraductal (noninvasive) breast cancer involving the surgical margins.
  3. Clinical evidence prior to surgery of infiltration of the skin of the involved breast such as edema, ulceration, or fixation of the tumour to underlying muscle, or inflammatory breast cancer.
  4. Bilateral malignancy of the breast (synchronous or metachronous).
  5. More than one primary invasive tumour in the same breast.
  6. Previous surgery for breast cancer.
  7. Pathological status of axilla is unknown.
  8. Status for adjuvant systemic therapy not determined.
  9. For patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 16 weeks of last surgical procedure on the breast.
  10. For patients treated with adjuvant chemotherapy: unable to commence radiation therapy within 8 weeks of the last dose of chemotherapy.
  11. Serious nonmalignant disease (eg. cardiovascular, renal, etc.) which would preclude surgical or radiation treatment.
  12. Currently pregnant or lactating.
  13. Breast deemed too large to permit satisfactory radiation (ie. separation > 25 cm).
  14. Previous concomitant malignancies of any type except squamous, or basal cell carcinomas of the skin, or carcinoma \fIin situ\fR of the cervix which have been effectively treated.
  15. Geographic inaccessibility for follow-up.
  16. Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.

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: Tissue Procurement Protocol for Patients Undergoing Neoadjuvant Systemic Therapy for Breast Cancer

Summary: This study is being performed so that tumor and blood samples from patients who will receive breast cancer treatment prior to surgery can be collected and stored for future research.

Detailed description: This protocol will provide a systematic approach to obtaining, cataloging, and distributing research tissue and blood from patients who will receive neoadjuvant systemic therapy for localized breast cancer.

Eligibility: Inclusion Criteria:
  1. All patients must have a primary measurable invasive breast cancer with the primary tumor intact (T1, 2, 3, or 4, any N, M0 or M1). Recurrent disease in the breast is also eligible.
  2. The patient's clinical plan will include neoadjuvant systemic therapy (chemotherapy, hormonal therapy, biologic therapy), prior to surgery on the breast.
  3. The clinical plan for patients with recurrent or M1 disease must include breast surgery after neoadjuvant systemic therapy. This would include patients with non-bulky M1 disease who the treating physicians feel would benefit from local control of disease after neoadjuvant systemic therapy.
  4. Patients must have had mammography performed at the University of Michigan, OR outside film review prior to enrollment.
  5. All patients are required to sign an informed consent regarding the experimental purpose of the research biopsies and serum banking, in accordance with the University of Michigan Institutional Review Board standards.
  Exclusion Criteria:
  1. Breast tumors that are not measurable by any of the modalities, including physical examination, mammography, or ultrasound.
  2. Tumors diagnosed by excisional biopsy, or incisional biopsy that does not leave measurable disease by physical examination, mammography, or ultrasound.
  3. Patients must not have received any prior chemotherapy, hormonal therapy, or radiation therapy for their current breast cancer. Patients who received tamoxifen or other agents for prevention of breast cancer may be included.
  4. Patients with another active systemic malignancy in the past 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: Beta-Blocker Continuation Versus Interruption in Heart Failure Worsening

Summary: The objective of the B-Convinced study is to demonstrate the non-inferiority of beta-blocker continuation compared to its interruption in patients with congestive heart failure who are treated by a beta-blocker and present with an episode of heart failure worsening with pulmonary oedema requiring hospital admission.
  162 patients will be randomized in cardiology centers in France. Clinical status (primary endpoint) will be evaluated with a standardized questionnaire 3 days after hospital admission.

Detailed description: Therapeutic strategy of beta-blocker treatment during an episode of heart failure worsening remains unclear. The objective of the B-Convinced study is to demonstrate that continuation of beta-blocker treatment in case of hospitalisation for heart failure worsening is as safe as the interruption of such treatment.
  Hypothesis: The proportion of patients clinically improving within 3 days is not inferior when beta-blocker treatment is maintained compared to beta-blocker interruption in case of hospitalisation for heart failure worsening with pulmonary oedema.
  Design: Open, randomized non-inferiority trial on two parallel groups of patients. Randomization performed centrally with a vocal server.
  Tested Hypothesis: 90% of success in the interruption group, power of 80%, non-inferiority limit of 15% (relative reduction). 162 patients are required with such a hypothesis.
  Primary Endpoint: Clinical improvement within 3 days of hospital admission evaluated by the investigator by a standardized questionnaire.
  Secondary Endpoints: Clinical improvement at day 8 or at hospital discharge, morbidity-mortality at 4 months.
  34 participating centres in France.

Eligibility: Inclusion Criteria:
  -  Patients with heart failure treated with beta-blocker; hospitalisation for heart failure worsening with pulmonary oedema.
  -  Left ventricular ejection fraction less than 40%
  Exclusion Criteria:
  -  Indication of intravenous positive inotropic treatment
  -  Indication to withdraw beta-blocker treatment

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

Clinical trial: The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer

Summary: Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.


Eligibility: Inclusion Criteria:
  -  Stage I-IIIa breast cancer
  -  Postmenopausal
  -  Recent surgery for breast cancer
  Exclusion Criteria:
  -  Metastatic disease
  -  Invasive bilateral disease
  -  Clinical or radiological evidence of existing fracture in spine or hip
  Other protocol-defined inclusion / exclusion criteria may apply.

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

Clinical trial: Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.

Summary: Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.


Eligibility: Inclusion Criteria:
  -  Stage I-IIIa breast cancer
  -  Postmenopausal or recently postmenopausal
  -  Recent surgery for breast cancer
  -  Estrogen Receptor positive and/or progesterone receptor positive hormone receptor status
  -  No prior treatment with letrozole
  Other protocol-defined inclusion criteria may apply.
  Exclusion Criteria:
  -  Metastatic disease
  -  Invasive bilateral disease
  -  Clinical or radiological evidence of existing fracture in spine or hip
  -  Prior treatment with IV bisphosphonates in the past 12 months
  -  Current treatment with oral bisphosphonates ( must be discontinued within 3 weeks of baseline evaluation)
  -  Use of Tibolone within 6 months
  -  Prior use of parathyroid hormone for more than 1 week
  -  Previous or concomitant malignancy
  -  Abnormal renal function
  -  History of disease effecting bone metabolism
  Other protocol-defined exclusion criteria may apply.

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

Clinical trial: PTEN and IGFBP-3 Correlation in Ovarian Carcinoma Invasion

Summary: We have identified insulin-like growth factor binding protein (IGFBP)-3 as an invasion suppressor gene in ovarian endometrioid carcinoma, and showed association with lower cancer migration, invasion and metastasis. Recently, a novel model of ovarian EC formation from endometriosis was reported, and PTEN was found to be a major protein involved. Inactivation of PTEN has been reported in some ovarian EC tumors and methylation was suggested as one of the major epigenetic changes. This tumorigenesis model has lots of similarity to our established invasion model. Therefore, we plan to study the important of PTEN expression in ovarian EC and if inactivation of PTEN and IFGBP-3 is through methylation. Furthermore, by studying the signal transduction pathways using PTEN and IGFBP-3 transfection, we plan to study the mutual interaction between PTEN and IGFBP-3 on the suppression of tumor invasion in ovarian EC.

Detailed description: We have successfully established an ovarian cancer cell line (OVTW-59), which was derived from an ovarian endometrioid carcinoma (EC), and have also established an ovarian EC invasion model. By using cDNA microarray and quantitative reverse-transcriptase polymerase chain reaction, we identified insulin-like growth factor binding protein (IGFBP)-3 as an invasion suppressor gene, which were associated with lower cancer migration, invasion and metastasis. Clinically, lower IGFBP-3 was found associated with significantly higher tumor grade, advanced stage and poor survival in patients with EC tumors. Furthermore, we have proved IGFBP-3 expression correlated with lower Erk activation, but with no effect on the activation of Akt. All these two signal transduction proteins have crucial roles in cancer invasion. Recently, a novel model of ovarian EC formation from endometriosis was reported, and PTEN was found to be a major protein involved. Inactivation of PTEN has been reported in some ovarian EC tumors and methylation was suggested as one of the major epigenetic changes. This tumorigenesis model has lots of similarity to our established invasion model. Therefore, we plan to study the important of PTEN expression in ovarian EC and if inactivation of PTEN and IFGBP-3 is through methylation. Furthermore, by studying the signal transduction pathways using PTEN and IGFBP-3 transfection, we plan to study the mutual interaction between PTEN and IGFBP-3 on the suppression of tumor invasion in ovarian EC.

Eligibility: Inclusion Criteria:
  Clinical diagnosis of ovarian endometrioid carcinoma
  Exclusion Criteria:
  other types of ovarian epithelial carcinoma

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 Decision Aid for Women With Early Stage Breast Cancer

Summary: To enhance information transfer and decision making for women with breast cancer.

Detailed description: Our specific objectives are: (i) to develop computer and paper based versions of the Decision Boards for (a) chemotherapy for early stage breast cancer (chemotherapy versus no treatment), (b) mastectomy versus lumpectomy plus radiation and (ii) to compare the relative effectiveness of the computer and paper based versions with the standard Decision Board for patients with early breast cancer.

Eligibility: Inclusion Criteria:
  Chemotherapy Group:
  -  Female
  -  Histologically documented invasive carcinoma of the breast treated with modified radical mastectomy or lumpectomy
  -  Axillary node dissection
  -  Chemotherapy alone or in addition to tamoxifen as an appropriate treatment option
  Surgery Group:
  -  Female
  -  Newly diagnosed carcinoma of the breast diagnosed either by cytology or pathological examination, OR if no biopsy, a strong clinical suspicion of malignancy
  -  Clinical stage I or II disease
  -  Candidate for breast conserving surgery
  Exclusion Criteria:
  Chemotherapy Group:
  -  Candidate for CEF chemotherapy
  -  Clinical evidence of metastatic disease
  -  Serious comorbidity that would preclude receiving chemotherapy treatment
  -  Unable to speak or read English fluently (including visual impairment)
  -  Mentally incompetent including any psychiatric or addictive disorders that would preclude shared decision-making
  Surgery Group:
  -  Previous surgery for breast cancer
  -  Previous breast irradiation
  -  Pregnant
  -  Clinical suspicion of bilateral breast cancer
  -  Serious comorbidity that would preclude definitive surgery
  -  Unable to speak or read English fluently (including visual impairment)
  -  Mentally incompetent including any psychiatric or addictive disorder that would preclude shared decision making

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: Efficacy of Acupuncture for Hot Flashes in Women Treated With Hormonal Therapy for Breast Cancer

Summary: The purpose of this study is to determine if acupuncture is effective in relieving hot flashes in women treated with hormonal therapy for breast cancer.

Detailed description: The purpose of this study is to determine if acupuncture is effective in relieving hot flashes in women treated with hormonal therapy for breast cancer.
  Hormonal therapy is one of the most common treatments for breast cancer in women. Unfortunately, many women on hormonal therapy suffer from hot flashes (the sudden sensation of heat throughout the face, neck and chest, with or without shivering and sweating). Many medicines have been used to treat hot flashes, but no single medication has been found to work reliably.
  Acupuncture has been shown to be effective for many conditions in Western medicine specifically for dry mouth in people who have received radiation to their head and neck, as well as for hot flashes in women during menopause (the "change of life"). In this study, we are investigating whether acupuncture is effective for women suffering hot flashes that result from their treatment of breast cancer.

Eligibility: Inclusion Criteria:
  -  Female
  -  18 years of age or older
  -  History of breast cancer who have received hormonal therapy
  -  Personal history of hot flashes
  -  Patients will be accepted if receiving therapy with traditional allopathic medicines if their hot flashes have persisted after two months
  Exclusion Criteria:
  -  Receiving therapy with traditional allopathic medicines for hot flashes

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 Doses of Candesartan Cilexetil on the Reduction of Proteinuria

Summary: The purpose of this study is to assess the effects of high doses of candesartan cilexetil and also to assess which dose (16mg, 64mg, 128mg) is the most optimal for the maximum reduction of proteinuria.


Eligibility: Inclusion Criteria:
  -  Informed consent
  -  Stable hypertension defined as no new antihypertensive medication started within 6 weeks of Visit 1
  -  Minimum 6-month history of hypertension and primary glomerular disease
  -  Hypertensive nephrosclerosis
  -  Diabetic nephropathy with stable proteinuria as defined by ≥ 1g/24 hours on more than one occasion within 6 months prior to Visit 1
  Exclusion Criteria:
  -  Persistent hypertension
  -  New anti-hypertensive medications started within 6 weeks of Visit 1
  -  Significant cardiac disease or Liver disease
  -  Females of childbearing potential without reliable contraception
  -  Pregnant women and women who are breast-feeding

Relevance to patient case: not relevant