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: Relationship of pAKT to Survival in Patients With Node-Positive Breast Cancer

Summary: This study will examine the relationship of a protein called pAKT to survival of breast cancer patients with one or more positive axillary lymph nodes. Akt plays a role in cell survival, tumor formation, and the development of drug resistance.
  The study will use tumor tissue obtained from 2,000 patients enrolled in a National Surgical Adjuvant Breast and Bowel Project study that is evaluating whether adding the drug paclitaxel (Taxol (Registered Trademark)) to a treatment regimen of doxorubicin (Adriamycin (Registered Trademark)) and cyclophosphamide (Cytoxan (Registered Trademark)) improves disease-free survival and overall survival in patients with node-positive breast cancer. The current study will measure levels of pAkt in the tissues and correlate the results with clinical outcome to see if pAkt levels are associated with improved patient survival.

Detailed description: Taxanes (paclitaxel and docetaxel) have emerged as the most powerful chemotherapeutics in breast cancer over the past decades. The B-28 clinical trial from the National Surgical Adjuvant Breast and Bowel Project (NSABP) assesses the efficacy of adding paclitaxel to the doxorubicin/cyclophosphamide regimen in the treatment of patients with axillary node positive breast cancer. The primary aim of B-28 is to determine whether four cycles of paclitaxel (Taxol (Registered Trademark)) (T) following four cycles of postoperative Doxorubicin (adriamycin (Registered Trademark) (A) and cyclophosphamide (C) will more effectively prolong disease-free survival (DFS) and survival (S) than four cycles of AC alone in patients with operable breast cancer who have one or more histologically positive axillary lymph nodes. The B-28 clinical trial tissue microarray consists of specimens from 2,000 cases enrolled. The tissue microarray set is an ideal platform for evaluating predictive markers of doxorubicin and/or paclitaxel response or resistance.
  Akt, a serine/threonine protein kinase regulated by the phosphatidylinositol 3-kinase (PI3K), is of importance in cell survival, tumorigenesis, and recently shown, chemoresistance. It confers survival advantage to cells by transducing signals from growth factor receptors that activate PI3K. The primary aim of this study is to evaluate whether the levels of phosphorylated AKT are associated with disease-free and overall survival in patients with node-positive breast cancer treated with AC and/or AC followed by paclitaxel.

Eligibility: -  INCLUSION CRITERIA
  The NSABP B-28 trial enrolled women from 1995 to 1998 with operable breast cancer with pathologically positive axillary lymph nodes.

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: Feasibility of Cetuximab Associated With Concomitant Radio-Chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer

Summary: Phase II, randomised, controlled, non comparative study with 2 parallel groups:
  -  Arm A: patients will receive induction chemotherapy (cisplatin and docetaxel) followed by a concomitant radio-chemotherapy including 2 cycles of cisplatin and vinorelbine associated with a weekly cetuximab infusion during the radiotherapy.
  -  Arm B: patients will receive induction chemotherapy (cisplatin and docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and etoposide associated with a weekly cetuximab infusion during the radiotherapy.


Eligibility: Inclusion Criteria:
  -  Non-Small-Cell Lung cancer cytologically or histologically proved
  -  Stage III AN2 inoperable or non resectable
  -  presence of at least one one dimension measurable target (at least 10 mm with spiral tomodensitometry)
  -  Possibility to include all targets in one irradiation field
  -  Age of 18 to 70
  -  Patients non previously treated
  -  Performance Status 0 or 1
  -  Loss of weight ≤10% in the 3 last months
  -  Neutrophil ≥ 1500/mm3 and platelets ≥ 100000/mm3
  -  Creatinine clearance ≥ 60 ml/min
  -  total bilirubin ≤ 1,5N and ASAT ALAT ≤ 2,5N
  -  Respiratory function normal: VEMS ≥ 40% theorical, DLCO/VA ≥ 50% theorical and PaO2 ≥ 60 mmHg
  -  Signed inform consent form
  -  Compliance to radiotherapy 66 Gy with dosimetry V20 ≤ 35% and pulmonary mean dose≤20 Gy
  Exclusion Criteria:
  -  Pretreated bronchial carcinoma, excepted endoscopic deobstruction
  -  operable bronchial carcinoma
  -  small cell lung cancer, composite cancer, neuroendocrine cancer, broncho alveolar cancer
  -  superior vena cava syndroms
  -  puncturable pleural effusion
  -  metastatic lung cancer
  -  Stage IIIb cancer with neoplastic pericarditis
  -  Previous thoracic irradiation
  -  severe cardiac disease in the 12 months before inclusion
  -  interstitial lung disease
  -  anti-EGFR and anti-VEGF treatments
  -  hypersensitivity to murine proteins and allergies to protocol drugs
  -  uncontrolled infectious state
  -  HIV patient
  -  corticoid definitive contraindication
  -  péripheric neuropathy grade≥2
  -  neurologic, psychiatric and organic disorder
  -  past or concomitant cancer excepted treated skin baso-cellular cancer or in situ cervical cancer, or any cancer only surgically treated for 5 years
  -  breastfeeding woman

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: Molecular Breast Imaging: A Novel Technology for Detection of Malignant Breast Lesions

Summary: Detection of breast cancer as early as possible is an ongoing imaging challenge.The purpose of the current study is to assess the clinical performance of the new scintigraphic technology, a dedicated breast gamma camera composed by the new generation of CZT detectors,for assessment of breast pathology specifically in women where current imaging techniques, mainly mammography are suboptimal. These cohort are patients with dense breast tissue and patients who are at high risk for breast cancer by a combination of other metrics, including family history and genetic testing. BRCA (breast cancer susceptibility gene), is particularly a relevant health problem among Ashkenazi Jews in Israel.

Detailed description: Recently, a breast-dedicated gamma camera has been used for assessment of breast malignancy in over 1000 women in Mayo Clinic, Rochester, USA. Molecular Breast Imaging (MBI), which utilizes a Cadmium-Zinc-Telluride (CZT) gamma camera for scintimammography, has been shown to have a high sensitivity (91%) for the detection of breast lesions > 5 mm in diameter and 69% for tumors smaller than 5mm.
  In Israel , genetic high- risk for breast cancer is highly relevant. We will offer the new imaging technology, to a wide patients population/group from all over Israel , in which the referring physician and/or the breast-imaging physician will look for additional imaging modality. Therefore this stage will include:
  -  Women with equivocal findings on Mammography, US and/or MRI
  -  Women with discrepancy between CBE(clinical breast examination)and breast imaging
  -  Women with dense breast
  -  Women in high risk for Breast Cancer
  Before the imaging procedure each woman will need to fill detailed questionnaire, specific for the study, that will include information on her medical history, family history, gynecology information, menstrual phase, use of hormones etc.
  The images will be correlated with other imaging tests including mammography, US and MRI. We will follow up the women for at least 6 months, including biopsy findings and or other clinical and imaging exams.
  This phase will include 500 women.

Eligibility: Inclusion Criteria:
  -  Age over 25.
  -  Equivocal breast lesions.
  -  Dense breast tissue.
  -  High-risk for breast cancer
  Exclusion Criteria:
  -  Age under 25.
  -  Pregnancy.
  -  Patients unable to understand and sign an 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: Anastrozole Reduced Proliferation and Progesterone Receptor Indexes in Short Term Hormone Therapy

Summary: Background: Identification of new biomarkers with potential predictive and prognostic role has contributed unequivocally to breast cancer treatment.
  Although traditionally endocrine therapy is based on hormonal receptors status (estrogen - ER and progesterone- PR), some patients become hormone resistant. In order to identify a possible profile associated to hormonal resistance, some biomarkers have been assessed after short period primary hormone therapy (HT).
  Objectives: To compare the expression of Ki-67, Bcl2, Bax, Bak, ER and e PR in postmenopausal women with ER positive invasive ductal carcinomas (IDC), prior and after tamoxifen and anastrozole in short term hormone therapy.


Eligibility: Inclusion Criteria:
  -  Invasive breast cancer post-menopausal women
  -  Estrogen and/or progesterone receptor positive
  Exclusion Criteria:
  -  Patients with endocrine disease
  -  Hormone therapy users or those who had been pregnant in the last 12 months before the diagnosis
  -  Patients with a negative expression for estrogen and/or progesterone receptors
  -  Women with a history of thromboembolism
  -  Patients who had previously undergone any treatment for breast cancer

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 & Pathological Studies of BRCA1/BRCA2: Associated Tumors & Blood Samples

Summary: The purpose of this study is to try to understand the biology of development of breast, ovarian, fallopian tube, peritoneal or endometrial cancer from persons at high genetic risk for these diseases. The influence of environmental factors on cancer development in individuals and families will be studied. The efficacy of treatments for these diseases will be evaluated.

Detailed description: 1. To establish a demographic database to evaluate the efficacy of medical interventions in patients and relatives who carry BRCA1 and 2 mutations and to compare these outcomes to patients who do not carry a BRCA1 or 2 mutation.
  2. To obtain blood samples from patients who undergo genetic testing to a) evaluate the incidence of genetic modifier polymorphisms involved in the development of cancer in BRCA1 and 2 mutation carriers and to compare this incidence to non-BRCA 1 and 2 carriers. b) to understand the interaction of genetic modifiers and BRCA1 and 2 in the development of cancer. c) to determine the effect of environmental influences on the incidence of polymorphisms in genetic modifiers and on the penetrance of BRCA1 and 2 mutations by linking information from our demographic database to blood samples and
  3. To obtain tumor tissue from BRCA1 and 2 carriers to utilize for gene expression studies.
  4. To establish a cohort of sporadic breast cancer patients, or women with no family history of cancer in a first degree relative, to serve as a comparison group to women with strong family history of breast cancer.
  5. To establish a cohort of healthy volunteers without personal or family history of cancer to serve as a comparison group to women with sporadic and familial breast cancer.

Eligibility: Inclusion Criteria:
  I. Women who have a high risk of developing breast or ovarian cancer due to a known germline mutation in the BRCA1/2, PTEN, CDH1, or TP53 cancer susceptibility genes, or due to strong family history of either breast or ovarian cancer, in the absence of known cancer susceptibility gene mutation.
  II. Women who are approaching surgery for resection of a pelvic mass, which is considered suspicious for neoplasia by radiologic or clinical criteria; such women may or may not also meet criteria for inclusion in group I.

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

Clinical trial: Breathing Disorders in Patients With Congestive Heart Failure

Summary: The investigators prospectively evaluated 89 consecutive outpatients (29 female) with stable congestive heart failure. The presence of sleep disordered breathing (SDB) and Cheyne-Stokes respiration (CSR) while awake were investigated by overnight polysomnography. Males and females were similar in age, body mass index, and LVEF. Prevalence of SDB was higher in males than females. During follow up of 25±10 months, 27% of the population died. Nonsurvivors had lower LVEF (p=0.01), worse NYHA class (p=0.03) a higher proportion of CSR-awake (p<0.001) than survivors.

Detailed description: Bakground: There is little information in sleep disordered breathing (SDB) in women with congestive heart failure (CHF). We studied consecutive CHF patients in order to compare SDB characteristics according to gender, and to determine overall mortality impact of SDB and Cheyne-Stokes respiration (CSR) while awake.
  Methods: Eighty nine consecutive outpatients (29 female) with stable CHF (LVEF<45%) were prospectively evaluated. The presence of SDB, as characterized by obstructive sleep apnea (OSA) and CSR during sleep, as well as CSR while awake before sleep onset, were investigated by overnight polysomnography.

Eligibility: Inclusion Criteria:
  -  Patients with resting left ventricular ejection fraction (LVEF) of less than 45% as determined by echocardiography;
  -  Stable clinical condition as defined by no changes in drug therapy for at least one month before evaluation.
  Exclusion Criteria:
  -  Patients with neurological, pulmonary, renal, musculoskeletal disease, unstable angina, primary valvular heart disease or previous diagnosis of sleep disordered breathing.

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: Mindfulness Based Stress Reduction: Supportive Treatment for Adult Patients With Cancer and Their Partners

Summary: The main purpose of this study is to evaluate the effects of the Mindfulness Based Stress Reduction (MBSR) training program that is offered in the investigator hospital, more specifically on quality of life, coping strategies and partner relationship by using questionnaires. To asses the possible impact of this treatment on the latter domain, partners of the patients with a cancer diagnosis are invited to join the training program.

Detailed description: Patients with breast cancer often experience anxiety, depression, stress and reduced quality of life. As such, there is an increased interest in the implementation of the Mindfulness-Based Stress Reduction program as an additional supportive treatment. MBSR is a structured group program that aims at reducing stress levels by enhancing awareness of the present moment in combination with a non-judgemental attitude.
  The study evaluates the effects of an 8-week MBSR program on quality of life, mood, depression, stress and coping skills in breast cancer patients.
  Breast cancer patients of the Breast Clinic of the Universitair Ziekenhuis Brussel participate in the MBSR program. Before and after the training program patients filled out questionnaires evaluating quality of life, coping skills, emotional functioning, stress and aspects of mindfulness.

Eligibility: Inclusion Criteria:
  For patients:
  -  Cancer diagnosis
  -  Between the age of 18 until 70
  -  Dutch speaking
  For partners:
  -  between the age of 18 until 70
  -  dutch speaking
  Exclusion Criteria:
  for patients and partners:
  -  Ongoing radiation therapy
  -  Psychiatric disorders
  -  Previous experience with mindfulness or meditation related techniques
  -  Pregnancy
  -  No or insufficient understanding of the Dutch language

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: 89Zr-trastuzumab PET for Imaging the Effect of HSP90 Inhibition

Summary: HSP90 inhibition is a potentially new targeted drug modality in the treatment of HER2 positive, trastuzumab refractory breast cancer. Little is known about the pharmacodynamics of HSP90 inhibitors in vivo, but non-invasive PET/CT imaging in a xenograft mouse model could visualize and quantify HER2 reduction after AUY922 treatment by 89Zr-trastuzumab PET imaging. Two doses of 50 mg/kg AUY922 resulted in a decrease in HER2 expression of approximately 50%, quantified 6 days after the last administration of AUY922.
  Visualizing HER2 expression in breast cancer patients before and early following HSP90 inhibition by means of 89Zr-trastuzumab PET, is likely to provide insight in the early in vivo effect of HSP90 inhibition and could potentially support patient tailored therapy.

Detailed description: This study is designed as a side study to the multicenter, international phase I-II trial with the HSP90 inhibitor AUY922 (protocol CAUY922A2101), as part of the biomarker assessment. In protocol CAUY922A2101, section 4, the design of this phase I-II trial is described (p36, 37). Briefly, a dose-escalation study is performed according to phase I design. This part is followed by a dose-expansion study according to a phase II design. In the latter part, breast cancer patients are enrolled that are either refractory to hormone- or trastuzumab treatment (both treatment arms, n=40 patients). Patients with HER2 positive, trastuzumab refractory breast cancer, will receive a 89Zr-trastuzumab PET scan as part of the present side study protocol, which will be performed in collaboration with the Royal Marsden Hospital (United Kingdom).
  To this end, a 89Zr-trastuzumab PET scan will be performed before (baseline) and during treatment with the HSP90 inhibitor AUY922, as described below.
  A minimum of six patients are needed to evaluate whether the 89Zr-trastuzumab PET scan can be used for the detection of a decrease of HER2 expression, induced by HSP90 inhibition.

Eligibility: Inclusion Criteria:
  -  Patients with HER2 positive, trastuzumab (and lapatinib) refractory breast cancer
  -  Participation in the phase I-II trial with HSP90 inhibitor AUY922 (in- and exclusion criteria for this study with AUY922 are described in protocol CAUY922A2101.
  Exclusion Criteria:
  -  No participation in the phase I-II trial with HSP90 inhibitor AUY922 (CAUY922A2101. Clinical trials no. NCT00526045A)

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: Congestive Heart Failure: Causes of Sudden Worsening

Summary: The purpose of the study is to recognize main causes of acute decompensation of chronic congestive heart failure.

Detailed description: Congestive heart failure (CHF) presents a very significant cause of morbidity and mortality. The prevalence of CHF is between 2 and 4% and rises with age (in 70- to 80-year-old people is between 10 and 20%). CHF is the cause of 5% of all acute hospital admissions and accounts for 2% of expenses on health. The most common causes of worsening of the chronic CHF are ischemia, arrhythmias, valvular dysfunction, systemic or pulmonary hypertension, volume overload or fluid retention, high output conditions (infection, anemia, thyrotoxicosis), drugs (NSAIDs, cyclo-oxygenase (COX) inhibitors, thiazolidinediones) and medication nonadherence. The goal of this study is to determine the proportion of various reasons of acute worsening of CHF, using commonly available methods including assessment of serum drug levels.

Eligibility: Inclusion Criteria:
  -  able to provide informed consent
  -  aged 19 years or more
  -  history of heart failure of at least one month
  -  examined or hospitalized for acute dyspnea at rest or with minimal exertion
  -  clinical signs of fluid overload defined as at least one of following:
  -  rales
  -  jugular venous distension
  -  peripheral edema
  -  pulmonary congestion on X-ray
  -  NT-proBNP above 210 pmo/l
  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: Everolimus in Breast Cancer Patients After Pre-operative Chemotherapy

Summary: This is a randomized controlled pilot study investigating signals involved in drug resistance to chemotherapy.
  Patient will be randomized to undergo observation or to receive Everolimus after completion of neoadjvuant treatment (anthracycline and/or taxane-based) and before surgery. The patients will be monitored for efficacy and safety.


Eligibility: Inclusion Criteria:
  -  Women aged ≥ 18 years;
  -  Histologically and/or cytologically confirmed invasive ductal or lobular breast cancer;
  -  Tumor of 3 cm or greater at time of diagnosis
  -  Measurable primary tumor after neoadjuvant treatment before randomization
  -  No prior chemotherapy for breast cancer;
  -  ECOG performance status ≤1 or Karnofsky performace status ≥ 70%
  -  Adequate liver/renal function
  -  Able to swallow whole tablets.
  -  Able to give written informed consent
  -  Able to follow prescription instructions reasonably well
  Exclusion Criteria:
  -  Male patient
  -  Prior history of other malignancy within 5 years of study entry, aside from contralateral breast carcinoma, appropriately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin
  -  Distant metastasis, including skin involvement beyond the breast area
  -  Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study

Relevance to patient case: not relevant