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: 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: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Quality of Life in African-American or Caucasian Female Breast Cancer Survivors

Summary: RATIONALE: Studying quality of life in cancer survivors may help determine the long-term effects of breast cancer and may help improve the quality of life for future cancer survivors.
  PURPOSE: This clinical trial is studying the quality of life in African-American or Caucasian female breast cancer survivors.

Detailed description: OBJECTIVES:
  -  Compare disease-specific, generic, and global quality of life measures in African-American survivors of breast cancer with Caucasian survivors of breast cancer.
  -  Compare these quality of life measures in African-American survivors of breast cancer with control group of African-American women with no history of breast cancer.
  OUTLINE: Patients and healthy participants complete a battery of quality of life (QOL) questionnaires over approximately 65 minutes by mail or over the phone, including the Sexual Function Index, Functional Assessment of Cancer Therapy - Fatigue, Concerns About Recurrence Scale, and other measures of symptoms/side effects (including sleep problems), the RAND Physical Functioning -10 Scale, Center for Epidemiologic Studies - Depression Scale, assessment of family function/social support, ENRICH Marital Satisfaction Scale, Reed Spiritual Perspective Scale, assessments of coping and body image, Post-Traumatic Growth Inventory, and the Index of Well-being. Demographic, disease, treatment, and comorbidity information, as well as menstrual and gynecological history, work status and insurance history, and a measure of health care provider communication is collected using questionnaires and medical chart review.
  PROJECTED ACCRUAL: A total of 195 patients and healthy participants will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  African-American or Caucasian breast cancer survivor
  -  Diagnosed with stage I-III breast cancer between the years of 1995-2003
  -  Receiving follow up care at the Indiana University Cancer Center (IUCC), the IUCC Northside Clinic, Spring Mill Clinic, or Wishard Memorial Hospital
  -  Healthy African-American
  -  Acquaintance of an African-American breast cancer survivor
  -  Not known to have breast cancer
  PATIENT CHARACTERISTICS:
  -  Female
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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: 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: 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: 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: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

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: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer

Summary: The purpose of this study is to learn whether neratinib is safe and effective in treating women with advanced HER2+ (human epidermal growth factor 2) breast cancer.

Detailed description: Arm A: HER2 gene amplification and disease progression following at least 6 weeks of standard doses of Herceptin; Arm B: HER2 gene amplification and no prior Herceptin or HER2-targeted treatment.

Eligibility: Inclusion Criteria:
  -  Pathologic diagnosis of breast cancer and current stage IIIB, IIIC, or IV
  -  Progression following at least 6 weeks of standard doses of Herceptin (Arm A only)
  -  Over-expression of HER2
  -  Tumor tissue available and adequate for analysis at screening
  -  At least one measurable lesion
  Exclusion Criteria:
  -  Prior treatment with Herceptin (Arm B only)
  -  More than 4 prior cytotoxic chemotherapy regimens
  -  Subjects with bone or skin as the only site of measurable disease
  -  Inadequate cardiac function
  -  Major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 1
  -  Active central nervous system metastases
  -  Pregnant or breastfeeding women
  -  Inability to swallow the HKI-272 capsules

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: SAM - Skip a Meal - Insulin Glargine, Diabetes Mellitus Type 1

Summary: Primary objective:
  To compare metabolic control as measured by Blood Glucose (BG) upon arising from bed (7:00 am - 12:00 pm) in type 1 Diabetes mellitus patients who skip the morning meal during treatment with MDI basal/bolus insulin: Difference of change of blood glucose between 7:00 am and 11:00 am between patients on Insulin glargine and NPH insulin.
  Secondary objective:
  To perform an evaluation between the two patient groups for BG (10:00 pm and 12:00 pm) as well as for serum insulin, free fatty acid levels and β-hydroxybutyrate (7:00 am - 12:00 pm).


Eligibility: Inclusion Criteria:
  Patients with type 1 Diabetes mellitus who have been treated with MDI (Multiple Daily Injection) basal/bolus insulin, regular insulin/short acting insulin analogue + NPH insulin on a stable dose (no change more than 10 %) for at least 4 weeks prior to study entry, who have an HBA1c smaller/equal 9 % (measured at visit 1) and a BMI smaller/equal 35 kg/m2. In addition, patients must have a FBG value at day 1 before skipping meal (6:00 am - 07:00 am) between 90 - 120 mg/dl (5.0 - 6.5 mmol/l).
  Exclusion Criteria:
  -  Breast-feeding
  -  History of hypersensitivity to the study medication or to drugs with similar chemical structures
  -  Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
  -  Treatment with any investigational drug in the last 30 days before study entry
  -  Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
  -  History of drug or alcohol abuse
  No subjects who have previously been treated with Insulin glargine will be enrolled in this 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: 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: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

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: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Preoperative Bevacizumab and Trastuzumab With ABI-007 and Carboplatin in HER2+ Breast Cancer

Summary: This trial combines trastuzumab and bevacizumab monoclonal antibodies, with ABI-007 and carboplatin, as neoadjuvant therapy in previously untreated locally advanced breast cancers demonstrating HER2 gene amplification. It is hoped that this novel combination will result in increased pathologic response rates that will translate into long term outcome improvements in HER2 positive patients with locally advanced breast cancer.

Detailed description: All eligible patients will receive induction chemotherapy prior to consideration of primary surgical intervention. If surgical intervention is deemed not to be in the best interest of the patient, patient will go off study at the time of evaluation for surgery. Upon completion of chemotherapy and surgery, all ER + and/or PR + patients will be placed on Tamoxifen 20 mg/qd or an aromatase inhibitor.
  Induction preoperative therapy:
  -  Bevacizumab
  -  Trastuzumab
  -  ABI-007
  -  Carboplatin
  Postoperative Adjuvant Therapy:
  -  Bevacizumab
  -  Trastuzumab

Eligibility: Inclusion Criteria:
  -  Female patients with histologically confirmed adenocarcinoma of the breast or inflammatory breast cancer
  -  Clinical stage T 1-4, N 0-3, M0
  -  FISH+ HER2 gene amplified breast cancer
  -  18 years or older
  -  Normal cardiac function
  -  Performance status 0-2
  -  Cannot have received any prior chemotherapy for this disease or cannot have received chemotherapy for any other cancer in the past 5 years.
  -  Previous diagnosis of noninvasive breast cancer is OK.
  -  Must have adequate bone marrow, renal and liver function.
  -  Pregnant or lactating females not allowed.
  -  Preexisting peripheral neuropathy must be equal to or less than grade 1
  -  Must have archived tumor tissue for tissue testing.
  Exclusion Criteria:
  You cannot be in this study if you any of the following:
  -  History of cardiac disease, with New York Heart Association Class II or greater with congestive heart failure
  -  Any heart attack, stroke or TIAs within the last 6 months or serious arrhythmias needing medication; no bleeding diathesis or coagulopathy.
  -  No prior investigational drug within the last 30 days
  -  No prior trastuzumab or bevacizumab therapy
  There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons.

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: Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder

Summary: This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label phase.


Eligibility: Inclusion Criteria:
  -  Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria
  -  HAM-D17 total score > or = 22 at Screening and Baseline
  -  CGI-Severity score > or = 4 at Screening and Baseline
  -  Only patients who complete the core protocol are eligible to participate in the Open-Label Extension Phase
  Exclusion Criteria:
  -  History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder
  -  Any current Axis I disorder other than major depressive disorder which is the focus of treatment
  -  Substance or alcohol abuse in the last 30 days, dependence in the last 6 months
  -  Concomitant psychotropic medication, including herbal preparations and melatonin
  -  Psychotherapy of any type
  -  Female patients of childbearing potential who are not using effective contraception
  Other protocol-defined inclusion/exclusion criteria may apply

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: 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