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: Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours

Summary: This study is primarily designed to assess the safety and tolerability of AZD4547 at increasing doses in patients with advanced solid malignancies and for whom no standard medication options are available. It also assesses the blood levels and action of AZD4547 in the body over a period of time.


Eligibility: Inclusion Criteria:
  -  Minimum life expectancy of 12 weeks
  -  The presence of a solid, malignant tumour that is resistance to standard therapies or for which no standard therapies exist
  -  In the expansion for the study patients must have a tumour at least 1cm in size that can be measure using a CT or MRI scan, and provide a tumour sample to the sponsor company for testing of FGFR1 and/or 2 amplification
  -  Expansion, 5 groups of advanced cancer
  -  Solid tumours,FGFR1 and/or FGFR2 gene amplified
  -  Squamous NSCLC, FGFR1 gene low & high amplified
  -  Gastric adenocarcinoma, including the lower oesophagus/gastro-oesophageal junction, FGFR2 gene low & high amplified
  -  Aged at least 25 years
  Exclusion Criteria:
  -  Treatment with any other chemotherapy, immunotherapy or anticancer agents within 3 weeks before the first dose of study
  -  An inability to be able to take the study medication
  -  A bad reaction to AZD4547 or any drugs similar to it in structure or class.

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 Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

Summary: The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.


Eligibility: Inclusion Criteria:
  -  Patients with histologically/cytologically confirmed advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation, for which no further effective standard anticancer treatment exists
  -  Adequate bone marrow function
  -  Adequate hepatic and renal function
  -  Adequate cardiovascular function
  -  Contraception.
  -  For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be nursing.
  -  For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment period
  Exclusion Criteria:
  -  Patients with primary CNS tumor or CNS tumor involvement
  -  Patients with history and/or current evidence of endocrine alteration of calcium-phosphate homeostasis
  -  History and/or current evidence of ectopic mineralization/ calcification including but not limited to the soft tissue, kidneys, intestine, myocard and lung with the exception of calcified lymphnodes and asymptomatic coronary calcification
  -  Current evidence of corneal disorder/ keratopathy incl. but not limited to bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis etc., confirmed by ophthalmologic examination.
  -  History or current evidence of cardiac arrhythmia and/or conduction abnormality
  -  Women who are pregnant or nursing.
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: possibly relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

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

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

Clinical trial: Positron Emission Tomography in Monitoring Treatment Response in Women With Newly Diagnosed Breast Cancer

Summary: This study will investigate the sensitivity and specificity of FLT-PET/CT in primary breast cancer detection and in the use of FLT-PET in monitoring how well a breast tumor respond to treatment. We will compare this technique with other imaging modalities as well as with tissue collection (during a biopsy). We will recruit women with a newly diagnosed invasive breast cancer, who are able to tolerate undergoing a PET/CT (possibly two scans) scan,

Detailed description: Our overall goal is to use this clinical trial as a platform to validate fibroblast activation protein (FAP) as a biomarker for the tumor microenvironment and to explore the dynamic interaction between proliferating tumor cells and the tumor microenvironment. Our long term goal is to develop new drugs that will target the tumor microenvironment as novel therapeutic and chemoprevention strategies.

Eligibility: Inclusion Criteria:
  -  Breast biopsy positive for an invasive malignancy (core needle, mammatone, or incisional biopsy)
  -  Participants must be planning to have surgery at the Hospital of the University of Pennsylvania
  -  Participants must be able to tolerating lying on the table for about an hour
  -  Newly diagnosed primary breast cancer, which is classified as being operable (T1-T4)
  Exclusion Criteria:
  -  Pregnant women
  -  History of severe renal disease
  -  Prior history of breast cancer of the study breast within the last five years.

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: Mannitol vs HS to Treat ICHT After Severe TBI : Comparison on PtiO2 and Microdialysis Values

Summary: The purpose of this study is to determine whether hypertonic saline is as much effective as mannitol to treat intracranial hypertension after traumatic brain injury and has at least the same effects on PtiO2 and cerebral metabolism studied through microdialysis.

Detailed description: Mannitol is frequently used to treat intracranial hypertension after TBI. However, it can be deleterious, particularly through hyperdiuresis and risks of hypovolemia. It also needs volume compensation and induces logistical problem because of needs of high infused volume to achieve osmolar load and avoid hypotension. Finally, some recent studies tend to prove superiority of hypertonic saline versus mannitol on the prognosis of TBI. especially through modulation of inflammatory reactions mechanisms and apoptosis.
  We would like to prove non inferiority of hypertonic saline versus mannitol after TBI to allow its large utilization, especially by field military doctors with specific logistical problems. For that, more than the single Intracranial Pressure, we want to study effects of HS vs mannitol not only on PtiO2 but also on cerebral microdialysis which gives informations on focal metabolism with profiles of ischemia, metabolic crisis, hyperglycolysis (possible reflect of neuronal restoration) and normality.

Eligibility: Inclusion Criteria:
  -  Severe Traumatic brain injury monitored with ICP, PtiO2 and cerebral microdialysis
  -  And ICP> 20 mm Hg needing osmotherapy
  -  And approval of the next of kind
  Exclusion Criteria:
  -  Bilateral fixed dilated pupils
  -  Contra-indication to multimodal neuromonitoring
  -  Previous CNS disease
  -  Contra-indication to HS (cardiac insufficiency,...)
  -  Natremia > 155 mmol/L or osmolarity > 320 mOsm/L

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: Safety Study of F2695 SR in Major Depressive Disorder

Summary: The purpose of this study is to evaluate the long- term safety of F2695-SR in the treatment of adults with major depressive disorder.


Eligibility: Inclusion Criteria:
  -  Completed 1 of the lead-in studies LVM-MD-01, LVM-MD-02, or LVM-MD-03
  -  Have normal examination findings at the final visit of the lead-in study
  -  Have a negative serum pregnancy test at the final visit of the lead-in study if a woman of child-bearing potential
  Exclusion Criteria:
  -  Any exclusionary psychiatric or medical condition that developed during the lead in study
  -  Patients considered a suicide risk
  -  Women who are pregnant, breastfeeding, or planning to become during the study OR are sexually active and not currently using a medically acceptable method of contraception

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 Study to Demonstrate the Safety and Preliminary Efficacy of 18F-FLT in Patients With Solid Tumours or Lymphoma

Summary: The Radiotracer 18F-FLT can non-invasively assess excessive cell growth in PET scan images. Tumour growth rate is a useful indicator of tumour aggression and response to treatment. Imaging and measuring the cell growth with 18F-FLT may be useful in monitoring response to anticancer treatment.

Detailed description: Clinical trial is a combined Phase I/II imaging, open label, single site study in patients with known or suspected carcinoma of the lung, breast, renal cell, pancreas or brain, and with gastrointestinal malignancies, neuroendocrine tumours, or lymphoma. One 18F-FLT PET scan will be performed in 10 Phase I patients, and pre-injection and post-imaging blood work and vital signs will be collected. Up to 5 18F-FLT PET scans will be performed in 170 Phase II patients.

Eligibility: Inclusion Criteria:
  -  Male or female greater than or equal to 16 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of last menstrual period, a negative pregnancy test is required.
  -  Patients with known primary or suspected primary, recurrent or metastatic carcinoma of the lung, breast, renal cell, pancreas or brain (including GGM, oligodendrogliomas, and brain metastases from any primary tumour) and with gastrointestinal malignancies, neuroendocrine tumours (including carcinoid and islet cell malignancies, or lymphoma, with at least one lesion >1 cm in diameter.
  -  Biochemical parameters as measured are required to be within 5 times the normal limits for age.
  -  Able and willing to follow instruction and comply with the protocol
  -  Provide written informed consent prior to participation in the study
  -  Karnofsky Performance Scale Score 50-100
  Exclusion Criteria:
  -  Previous removal of entire tumour
  -  Biochemical parameters as measured outside 5 times the normal limits for age
  -  Unable or unwilling to follow instructions and comply with the protocol
  -  Unable or unwilling to provide written informed consent prior to participation in the study
  -  Karnofsky Performance Scale Score < 50
  -  Nursing or pregnant females
  -  Age less than 16 years

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: Detection of Amplification of Her2 Fluorescent in Situ Hybridization (FISH) in Breast Tissue Sections

Summary: The purpose of the study is the identification of amplification level in human breast tissue. The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classification of Her2 FISH stained tissue samples.


Eligibility: Inclusion Criteria:
  -  Well stained breast tissue slides with bright Her2 signals
  Exclusion Criteria:
  -  Very old slides that were already bleached

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

Clinical trial: Carcinogenicity Study of Bupropion

Summary: There is a lack of toxicology data on one bupropion metabolite, and limited literature examining bupropion use and cancer risk. This study evaluates the association between bupropion exposure and the development of cancer of the prostate, breast, lung, colon/rectum, urinary bladder, and uterus by comparing the risk of cancer in bupropion users with other antidepressant users. Because there is no evidence that bupropion is associated with any particular cancer, we have chosen the six most common cancers diagnosed in the United States to optimize statistical power/precision for cancer-site specific comparisons. Two US population-based data resources with automated claims, pharmacy, and tumor registry data are included in this study. Using a nested case-control design, this study will compare the incidence of cancer in patients exposed to bupropion with the incidence in patients exposed to other antidepressants.

Detailed description: Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

Eligibility: Inclusion Criteria:
  Exclusion Criteria:
  -  Cancers diagnosed within 12 months of initiation (i.e., new use) of antidepressant pharmacotherapy will be excluded to account for a minimum period for the development of cancer (cancer latency) and to be consistent with other studies of antidepressants and cancer.
  -  Patients with a history of any cancer (cancer diagnosis recorded in the tumor registries anytime before the first antidepressant prescription recorded during the study period)
  -  Any antidepressant use within 6 months of January 1, 1996

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: Estrogen for Triple Negative Breast Cancer

Summary: The purpose of this study is to determine the effectiveness of Estradiol treatment for advanced breast cancer that is hormone receptor negative and Her2/neu negative. The study will also use tumor tissue from your original diagnosis or from a biopsy you may have had for your cancer to look at hormone receptors in the lab. The tissue left over from your previous surgery or a previous biopsy will be used for research tests to check whether a different estrogen receptor (estrogen receptor beta) is seen in the tumor and if that makes estrogen work better.


Eligibility: Inclusion Criteria:
  -  histologically or cytologically confirmed breast cancer which is metastatic.
  -  A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be available from either a prior biopsy of the primary tumor or a metastatic site. .
  -  Primary tumor or metastatic biopsy lacking estrogen and progesterone receptor and Her2 negative
  -  Patients must have measurable disease.
  -  Eastern Cooperative Oncology Group performance status 0-1.
  -  Patients with bone metastasis at baseline must agree to treatment with intravenous bisphosphonates
  -  Subjects may have had 0-4 lines of prior systemic chemotherapy or targeted therapy regimens administered for treatment of their metastatic breast cancer.
  -  Age >18 years
  -  Life expectancy of greater than 3 months.
  -  Patients must have adequate organ and marrow function as defined below:
  Exclusion Criteria:
  -  systemic chemotherapies, targeted therapies or radiotherapy for their cancer within 2 weeks prior to entering the study
  -  Patients receiving any other investigational agents for breast cancer treatment.
  -  Patients with known brain metastases are excluded 3.2.4 History of allergic reactions attributed to compounds of similar chemical or biologic composition to estradiol.
  -  Patients with any condition of the gastrointestinal tract that is expected to result in an inability to take oral medication
  -  Dysfunctional or post-menopausal vaginal bleeding.
  -  Uncontrolled hypercalcemia/hypocalcemia
  -  Prior history of or active thrombophlebitis, cerebral vascular accident, myocardial infarction, deep venous thrombosis or pulmonary embolism.
  -  History of or active hepatic adenoma.
  -  Uncontrolled intercurrent illness
  -  Pregnant women are excluded from this study
  -  Patients with bone metastasis are excluded if they are unable to receive intravenous bisphosphonate therapy due to the risk for developing hypercalcemia.

Relevance to patient case: not relevant