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: De Novo Resistance to Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors

Summary: This study is based on the following hypothesis "De novo resistance to EGFR-TKI in EGFR mutation positive patients is related with mutations in EGFR downstream genes".
  Investigators will prospectively collect genomic DNA and clinical data regarding treatment outcomes to EGFR-TKI in NSCLC patients with activating EGFR mutations. Investigators will sequence candidate mutations of EGFR downstream genes and analyze c-met gene amplification and protein expression in PTEN, HGF, and IGFR. To identify genetic mutations, amplification, and protein over expression as predictive markers of treatment outcomes, investigators analyzed the association of treatment outcomes with the presence of genetic alteration or protein over expression. Investigators will attempt to identify biomarkers that are able to predict de novo resistance to EGFR-TKI in EGFR mutated NSCLC.

Detailed description: Investigators will prospectively enroll patients who match the following criteria: pathologically proven unresectable NSCLC, planning to treat with EGFR-TKI, patients with activating EGFR mutations, and available tissue sample for DNA extraction.

Eligibility: Inclusion Criteria:
  1. Pathologically proven unresectable NSCLC
  2. 20 years of age or older
  3. Planned treatment with Iressa®
  4. Patients with activating EGFR mutation (del 19, L858R)
  5. Available detailed smoking history
  6. Available tissue samples (archival tissue) for mutational or molecular analysis (representative paraffin block or unstained sections from tumor diagnostic specimen are mandatory)
  7. Available blood sample
  8. At least one lesion that is measurable according to the RECIST 1.1 criteria by CT or MRI
  9. Written informed consent
  Exclusion Criteria:
  1. More than 3rd line treatment
  2. Previously treated with other EGFR-TKI
  3. Life expectancy of less than 12 weeks
  4. Pregnant or lactating female
  5. Any unresolved toxicity greater than CTC grade 2 (version 4.0) from previous anti cancer treatment.
  6. Unsuitable patient in this treatment as determined by doctor.

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: The Safety and Effects of Gefitinib in Triple-negative,EGFR Positive Metastatic Breast Cancer

Summary: Breast cancer is a heterogeneous disease and can be classified into several distinctive subgroups. Triple-negative breast cancer(TNBC) is defined by lack of estrogen(ER), progesterone(PR) immunoreactivity and lack of human epidermal receptor-2(HER2) overexpression. TNBC comprises around 15% of all breast cancer and is characterized by its aggressive clinical behavior and insensitivity toward available targeted treatment strategies such as endocrine and anti-HER2 therapies.Although TNBC is sensitive to chemotherapy,early relapse with metastatic disease is common and the prognosis is poor. Development Of novel treatment strategies is,therefore,needed and the study of other potential targets in TNBC,like tyrosine kinase receptors,is a topic of interest.
  Epidermal Growth Factor Receptor(EGFR) is a transmembrane receptor tyrosine kinase that encoded by cell erythroblastosis virus oncogene B1(C-erbB1) and belongs to the HER/Erythroblastosis virus oncogene B(ErbB) family. By several signal pathways,EGFR regulates cell proliferation, differentiation, apoptosis, invasion,and angiogenesis,and serves as a poor prognostic factor.EGFR is overexpressed in a variety of malignancies including TNBC.Gene expression profiling and immunohistochemical studies have indicated that 40 to 60% of TNBCs exhibit EGFR expression and gene amplification was found in 18% of this subgroup,but EGFR mutation was rare in TNBC.
  By far,the role of gefitinib, an EGFR tyrosine kinase inhibitor(TKI),in the metastatic TNBC has not been identified. Most clinical trials about EGFR TKIs in the breast cancer have one or more limitations including:1) the study population had received heavily pretreatment; 2)the enrolled patients included several subgroups of breast cancer; 3)the expression of EGFR was not clear in the enrolled patients.
  Here, the investigators launch a prospective clinical trial, and about 50 patients with triple-negative,EGFR positive metastatic breast cancer that have received at least second line therapy will be enrolled. these patients will be treated with gefitinib, the toxicity and effects of gefitinib will be recorded prospectively to evaluate the role of gefitinib in the metastatic TNBC.


Eligibility: Inclusion Criteria:
  -  ≥18 years of age
  -  ≥1 measurable or assessable lesion
  -  Eastern Cooperative Oncology Group(ECOG)performance status of 0-2
  -  adequate renal,hepatic and hematological function
  -  a life expectancy of >12 weeks
  -  histologically proven EGFR positive metastatic TNBC
  Exclusion Criteria:
  -  brain metastasis

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: The Association Between Alpha 1 Acid Glycoprotein Level and Outcome Metastatic Cancer Treated With Docetaxel

Summary: Docetaxel based chemotherapy is a standard therapy in various metastatic cancers including lung cancer, breast cancer, gastric cancer, prostate cancer, and bladder cancer.
  One of the main plasma protein carriers of docetaxel is Alpha 1 acid glycoprotein.
  Retrospective data suggests that plasma level of alpha 1 acid glycoprotein is associated with the outcome of docetaxel based therapy in cancer patients.
  The investigators aim to prospectively study the association between the plasma level of alpha 1 acid glycoprotein and the outcome of docetaxel based therapy in cancer patients.

Detailed description: Docetaxel based chemotherapy is a standard therapy in various metastatic cancers including non small cell lung cancer, breast cancer, gastric cancer, prostate cancer, and bladder cancer.
  One of the main plasma protein carriers of docetaxel is Alpha 1 acid glycoprotein
  Retrospective data suggests that plasma level of alpha 1 acid glycoprotein is associated with the outcome of docetaxel based therapy in non small cell lung cancer patients.
  The investigators aim to prospectively study the association between the baseline plasma level of alpha 1 acid glycoprotein (measured on the first day of the first cycle of docetaxel) and the outcome (response rete, progression free survival, overall survival) of docetaxel based therapy in patients with metastatic non small cell lung cancer, breast cancer, stomach cancer, prostate cancer, and bladder cancer.

Eligibility: Inclusion Criteria
  -  patients with metastatic cancer from lung, breast, gastric, prostate, and bladder origin
  -  patients must be treated with docetaxel based chemotherapy
  -  patients must sign an informed consent form
  Exclusion Criteria
  -  patients with metastatic cancer other than lung, breast, gastric, prostate, and bladder origin
  -  patients treated with chemotherapy other than docetaxel
  -  patients that did not sign an informed consent form

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: The Prone Breast Radiation Therapy Trial

Summary: Participants undergoing radiation after breast conserving surgery for an early breast cancer (either Ductal Carcinoma In Situ (DCIS), or Early Stage Invasive breast cancer), and are at increased risk of developing a skin reaction because of their large breast size.
  After breast conserving surgery (also known as a 'lumpectomy'), women with either DCIS or early stage invasive breast cancer receive radiation to the breast to decrease the risk of cancer recurrence. Breast radiation is usually done with women lying on their back ("supine"). Some women develop temporary breakdown of the skin (moist desquamation). This skin reaction can be painful and has been linked to long term side effects such as chronic pain and decreased quality of life.
  This study is being done because women with large breasts have higher rates of skin breakdown (called 'moist desquamation') and breast pain during and shortly after radiation therapy is complete. It is unclear if such skin reactions and pain would be improved by alternating treatment position - namely lying on your belly ("prone") during their radiation treatment.

Detailed description: The risk of moist desquamation in large breasted women remains unacceptably high and reactions tends to be severe and produce significant permanent and delayed side effects. Evidence suggests that the use of a prone breast IMRT technique has the potential to decrease the risk of moist desquamation in large breasted women to the levels that are now seen when average/smaller breasted women are treated with supine IMRT. As prone breast XRT is currently only offered at 6 of 15 of the Ontario Cancer Centres polled for the purposes of providing motivation for this study, a multicentre RCT is feasible to confirm and quantify the improvement provided by the prone technique and provide Level 1 evidence for it to be adopted world-wide.

Eligibility: Inclusion Criteria:
  -  confirmed histological diagnosis of breast carcinoma or ductal carcinoma in situ (DCIS);
  -  treated with BCT;
  -  no indication for treatment of regional LN;
  -  Women with a bra size of 40 inches or greater, or a pre-surgery cup size of D or greater
  Exclusion Criteria:
  -  Regional Lymph Node XRT indicated;
  -  Bilateral breast cancer;
  -  unhealed wound (skin not closed and/or infection);
  -  previous XRT to the same breast;
  -  unable to lie prone;
  -  presence of active connective tissue disease;
  -  pregnancy;
  -  unacceptable heart exposure (as measured by > 10% of the heart receiving 50% of the prescribed dose, i.e. V25Gy > 10%);
  -  adequate coverage of postoperative tumour bed not technically possible

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 Lifestyle Intervention for Breast Cancer Survivors

Summary: 1. The purpose of the study is to test the effectiveness of a new mail-based intervention for breast cancer survivors compared with standard lifestyle management and no-treatment.
  2. This intervention addresses both lifestyle factors such as dietary and physical activities and psychological issues specific to breast cancer survivors to improve healthy behaviors.

Detailed description: Participants will be assigned randomly to one of three groups: 1) newly developed mail-based intervention (Targeting the Teachable Moment Intervention; TTMI), 2) standard Lifestyle Intervention (SLM), and 3) usual care. Both TTMI and SLM focus on health behaviors, however TTMI additionally addresses psychosocial issues specific to breast cancer survivors.
  All participants will complete questionnaires at the time they start the study, the end of the 4 months, and 3 months later for a follow-up.
  If participants are assigned to any of the intervention group, they will receive materials every other week for 4 months. If participants are assigned to the usual care group, they will receive the same materials as the standard lifestyle intervention et the end of the 7 months.

Eligibility: Inclusion Criteria:
  -  First diagnosed with breast cancer in the past 1.5 years
  -  stage 0~2 breast cancer
  -  no prior adjuvant treatment for another cancer
  -  Can read and write English
  -  Are not participating in other health behavior research right now
  Exclusion Criteria:
  -  apparent serious mental disturbance
  -  male breast cancer survivors

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: Danshen Dropping Pill for Coronary Heart Disease Heart and Artery Structure and Function

Summary: The Impact of Compound danshen dropping pill for coronary heart disease (CHD) heart and artery structure and function in patients with hypertension

Detailed description: Compound danshen dropping pill for coronary heart disease (CHD) heart and artery structure and function in patients with hypertension.We can accorand the pwv ,IMT and MDA to assess the impact of heart and artery structure and function.

Eligibility: Inclusion Criteria:coronary heart disease，primary hypertension， -
  Exclusion Criteria:secondary hypertension，diabetes mellitus，chronic renal disease，cardiac insufficiency

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 a Comprehensive Breast Cancer Treatment Patient Decision Tool

Summary: This study examines the impact of an online decision tool for patients with early stage invasive breast cancer. The study is a randomized controlled trial (RCT) of 444 newly diagnosed patients, recruited from multiple surgical practices in two SEER catchment areas. Participants will be randomized to receive either a basic version of a decision tool (similar to existing website with breast cancer information) or an enhanced version (featuring a knowledge building component, a values clarification exercise, and a patient activation module). Our hypothesis is that patients who use the enhanced version of the tool will have greater knowledge of their test and treatment options, have a higher rate of high quality (i.e., informed, preference-concordant) decisions, and report more positive appraisal of the decision-making process.

Detailed description: Patients newly diagnosed with breast cancer face a series of complex decisions regarding locoregional and systemic treatment. Currently many of these decisions do not meet the definition of a high quality decision, defined as one that is both informed (i.e., based on an accurate understanding of the treatment risks and benefits) and preference-concordant (i.e., consistent with the patients' underlying preferences). Moreover, the introduction of evaluative tests has made these decisions more complicated for many patients. There is a need to improve the quality of locoregional and systemic treatment decisions for breast cancer patients, and to help patients understand the role of evaluative tests in this decision process. Ensuring patients can deliberate effectively about these decisions, assert their views and communicate with their clinicians is likely to improve their overall decision preparedness and satisfaction. This study will focus on the third pillar of individualized care by evaluating the impact of an innovative decision tool on locoregional and systemic therapy decision making for newly diagnosed breast cancer patients. The innovative online decision tool has been developed and tested over the past two years by the CanSORT team (R21 CA129859). Pilot data suggests that this tool has a positive impact on patient knowledge and decision outcomes. The goal of this study is to evaluate the impact of this tool, after it is enhanced in collaboration with our Communication and Dissemination Core, on the quality of decision making for locoregional and systemic breast cancer treatment decision making.

Eligibility: Inclusion Criteria:
  -  Stage 1-2 invasive breast cancer diagnosis,
  -  DCIS
  -  Ability to read English
  Exclusion Criteria:
  -  Male

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: Phase II Study of Dovitinib for FGFR1 Amplified Squamous Non-small Cell Lung Cancer

Summary: Efficacy of Dovitinib for Squamous NSCLC.


Eligibility: Inclusion Criteria:
  -  histologically confirmed squamous NSCLC
  -  Previously treated with one or two lines of chemotherapy
  -  FGFR amplification (FISH > 5 copies of genes)
  -  20 years or older
  -  ECOG PS 0-2
  Exclusion Criteria:
  -  active infection
  -  uncontrolled brain metastasis
  -  unstable angina or MI

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 Comparing ex Vivo MRI Versus Radiography of Breast Specimens

Summary: Radiography of breast specimens is currently the only radiological procedure used to verify removal of microcalcifications and presence of tumor-free margins after breast surgical resection. Ex vivo MRI will be tested for its ability to detect residual tumor tissue not detected by radiography in resected breast tumor specimens and/or its ability to verify tumor-free margins in breast cancer detected by MRI only.


Eligibility: Inclusion Criteria:
  -  Women with malignant breast disease identified by microcalcifications without clinically evident disease
  -  Women candidate to breast preserving surgery
  Exclusion Criteria:
  -  Cardiac pacemaker, defibrillators, cardiac monitors
  -  Brain stimulators, implantable spinal stimulators
  -  Vascular and aneurismal clips
  -  Hemostatic clips
  -  Infusion pumps
  -  Glaucoma drainage implants
  -  Metallic foreign body positioned in vital organ of the patients
  -  Some heart valves
  -  Some vascular access ports, infusion pumps and catheters
  -  Permanent contraceptive tubal device
  -  Kidney disease

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: Increasing the Efficiency of Depression-screening Using Patient-targeted Feedback

Summary: Out-patients with coronary heart disease or hypertension will fill out a depression screening questionnaire while waiting in a cardiac clinic. Using a randomised-controlled study design half of the patients will receive a patient-targeted written screening feedback. This feedback contains information about depression in general, depression-severity adapted treatment guidelines and contact-information for treatment. Patients in the control group receive no direct screening-feedback but their cardiologist will be informed about the screening result. All patients with a positive screening-result will be contacted after one month and six months and asked for symptoms of depression, and their use of health care. The aim of this study is to evaluate the efficiency of this minimal intervention on the course of depressive symptom in patients with known coronary heart disease or hypertension.

Detailed description: The aim of this study is to evaluate the efficiency of a minimal intervention on the course of depressive symptoms in patients with known coronary heart disease (CHD) or hypertension. By means of a depression screening and individual patient-targeted feedback the level of depression should decrease, the percentage of treated depressed patients should increase and health economic costs should be lowered. The main hypothesis is that screening plus targeted feedback results in a greater reduction of depression than screening only.

Eligibility: Inclusion Criteria:
  -  Gender: Both, male and female
  -  Minimum Age: 18 Years
  -  Maximum Age: no maximum age
  -  Attendance in a cardiac clinic;
  -  Clinical diagnosis of coronary heart disease or hypertension;
  -  Age ≥ 18 years;
  -  Sufficient language skills;
  -  Informed consent
  Exclusion Criteria:
  -  Life threatening health status;
  -  Severe somatic or/and psychological disorder that needs urgent treatment;
  -  Acute suicidal tendency;
  -  Severe cognitive or/and visual difficulties;
  -  Not being able to fill out questionnaires

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: Phase I Study in Healthy Male Subjects Comparing QGC001 to Placebo

Summary: QGC001/1QG1 is a Phase I "first time in man" study aiming to determine the overall safety and tolerability of single ascending oral doses of QGC001 in healthy male subjects compared to placebo, as well as the pharmacokinetics of QGC001 and its metabolite EC33 and the pharmacodynamic properties of QGC001 (effects on the renin-angiotensin-aldosterone system, blood pressure and heart rate) in healthy male subjects.


Eligibility: Inclusion Criteria:
  -  Caucasian, male healthy subjects of 18 to 45 years of age.
  -  Body weight ≥50 kg, with a body mass index calculated as weight in kg/(height in m2) from 18 to 27 kg/m2 at screening.
  -  Subjects will sign and date an informed consent form before any study-specific screening procedure is performed.
  -  Healthy, as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12 lead ECG readings.
  -  Non-smoker or smoker of fewer than 5 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
  -  Have a high probability for compliance with and completion of the study.
  Exclusion Criteria:
  -  Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatological, haematological, neurologic, psychiatric disease or history of any clinically important drug allergy.
  -  Acute disease state within 7 days before study day 1.
  -  History of drug abuse within 1 year before study day 1.
  -  History of alcoholism within 1 year before day 1. Consumption of more than 50 g of ethanol per day.
  -  Positive serologic findings for human immunodeficiency virus antibodies, hepatitis B surface antigen, and/or hepatitis C virus antibodies.
  -  Positive findings of urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA)
  -  History of any clinically important drug allergy.
  -  Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product administration.
  -  Consumption of any caffeine-containing products in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 hours before study day 1.
  -  Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before investigational medicinal product administration.
  -  Donation of blood (i.e. 450 ml) within 90 days before study day 1.

Relevance to patient case: not relevant