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: The Role of Endothelin in Pulmonary Hypertension

Summary: The purpose of the study is is to determine the effect, on the lung circulation, of BQ-123, an investigational compound which is not approved by the FDA.

Detailed description: Endothelin levels are increased in patients with pulmonary hypertension. We wish to compare the effect of an endothelin antagonist on pulmonary hypertension due to a variety of causes.

Eligibility: Inclusion Criteria:
  -  known diagnosis of pulmonary hypertension
  Exclusion Criteria:
  -  hypertension due to other reasons (not pulmonary)

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: Irinotecan and Panitumumab as 3rd Line Treatment for mCRC Without KRAS Mutations

Summary: The purpose of this study is to investigate the effect and the side effect profile of irinotecan and panitumumab administered every 3 weeks as 3rd line treatment for patients with metastatic colorectal cancer without KRAS mutations.

Detailed description: Colorectal cancer is one of the most frequent types of cancer in Denmark with approximately 3,400 diagnosed patients per year. The prognosis for these patients is still very poor and more than half of them will develop metastatic disease and thus be candidates for chemotherapy.
  In Denmark 5-FU and Oxaliplatin or Irinotecan has been used for several years either as combination or mono therapy. In recent years biological antibodies targeted against EGFR have been added to this treatment. A newly developed antibody is Panitumumab, which enables treatment every 3 weeks instead of weekly administration.
  The effect of EGFR activation is mediated through intracellular pathways involving the KRAS protein. It has been proven that a mutation of KRAS causes the KRAS protein to be constantly activated, and patients with these mutations do not benefit from antibodies against EGFR. Approximately 40% of the patients present these mutations.

Eligibility: Inclusion Criteria:
  -  Histologically verified adenocarcinoma in colon or rectum with metastatic spread.
  -  No mutations in the KRAS gene.
  -  Resistance to 5-FU, oxaliplatin and irinotecan.
  -  Age ≥18 years.
  -  PS 0-2.
  -  Measurable disease according to RECIST criteria.
  -  Haematology: Neutrophilocytes ≥1.5 x 109/l, leukocytes ≥3.0 x 109/l, thrombocytes ≥100 and bilirubinaemia ≤3 x upper normal value. Samples no more than 4 weeks old.
  -  Fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment.
  -  Acceptance that blod and tissue samples are kept for subsequent investigation of biomarkers.
  -  Oral and written informed consent.
  Exclusion Criteria:
  -  Other malignant disease within the past 5 years, excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri.
  -  Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks.
  -  Verified or clinically suspected CNS metastasis.
  -  Other experimental treatment.
  -  Serious medical disease according to investigator's judgement.
  -  Pregnant or breastfeeding women.
  -  Hypersensitivity to the active substance or to one or more of the auxiliary substances.
  -  Patients with interstitial pneumonitis or pulmonary fibrosis.

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: Pre-operative Magnetic Resonance Imaging (MRI) in Young Breast Cancer Patients

Summary: Young women with breast cancer have an increased breast tissue density and conventional imaging tests such as mammography and breast ultrasound are less sensitive and specific for detecting breast cancer than in older breast cancer patients. Breast MRI is an emerging tool that has been proven to improve the ability to identify breast cancers by determining the extent of disease and also detect multifocal, multicentric and bilateral breast cancers. To date, the role of pre-operative breast MRI is not clearly defined. The investigators are proposing a study to evaluate the impact of preoperative breast MRI on surgical decision-making in breast cancer patients <= 50 years. This may lead to improved characterization of breast cancers in these younger patients that may ultimately result in lower local recurrence rates in the future. The additional information attained through the breast MRI may also guide the use of radiation, chemotherapy and/or hormonal therapy in these patients.

Detailed description: Inclusion Criteria:
  -  female aged ≤ 50
  -  histologically proven invasive breast cancer
  Exclusion Criteria:
  -  Is not considered a surgical candidate
  -  Has had prior breast cancer surgery or an excisional biopsy of the newly diagnosed lesion
  -  Has a contraindication to undergoing breast MRI
  -  Has inflammatory breast cancer according to the standard clinical definition
  -  Has locally advanced breast cancer according to the standard clinical definition
  -  Patient is pregnant
  -  Has a psychiatric or addictive disorder that would preclude obtaining informed consent or adherence to the protocol

Eligibility: Inclusion Criteria:
  -  Female aged <= 50 years
  -  Histological proof of invasive breast cancer via fine needle aspiration or core needle biopsy
  -  Premenopausal
  Exclusion Criteria:
  -  Patient not considered an appropriate surgical candidate; i.e., patient is not well enough to have breast cancer surgery
  -  Patient has had prior breast cancer surgery or an excisional biopsy of the newly diagnosed cancer
  -  Patient has a contraindication to undergoing breast MRI (i.e., pacemaker, neurodefibrillator, metallic foreign bodies, etc.)
  -  Patient has inflammatory breast cancer according to the standard clinical definition. This is a type of breast cancer in which there is evidence of erythema and/or edema. The skin of the breast may also have changes of peau d'orange.
  -  Patient has locally advanced breast cancer according to the standard clinical definition.
  -  Patient is pregnant
  -  Patient has a psychiatric or addictive disorder that would preclude them from obtaining 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: Arimidex Bone Mass Index and Oral Bisphosphonates

Summary: To investigate the management of bone health in postmenopausal women with early breast cancer (BCA) scheduled to receive anastrozole. Postmenopausal women with hormone receptor-positive early BCA are assigned to 1 of 3 strata depending on their pre-existing risk of fragility fracture. Patients (pts) with a bone mineral density (BMD) T-score <-2.0 for either spine or hip are designated higher-risk (H) for fracture and receive anastrozole 1 mg/day plus risedronate orally. Moderate-risk (M) pts (T-score <-1.0 for spine or hip but -2.0 at both sites) are randomized to receive anastrozole plus risedronate (A+R) or anastrozole alone. Pts with T-scores -1.0 at both spine and hip were designated lower-risk (L) and receive anastrozole alone. All pts receive calcium and vitamin D. Lumbar spine and total hip BMD are assessed at baseline, 12, and 24 months.


Eligibility: Inclusion Criteria:
  -  Postmenopausal women
  -  ER and or PgR positive breast cancer
  -  Completed Surgery and =/- chemotherapy
  Exclusion Criteria:
  -  metastases
  -  history of fractures
  -  HRT or SERMs
  -  Liver or kidney disfunction

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: PET/CT Guided Fulvestrant Therapy for Patients With Recurrent or Metastatic Breast Cancer

Summary: Purpose:
  To determine whether [18F]FES can predict clinical benefit (defined as complete response, partial response and stable disease ≥ 6 months) to fulvestrant (250 mg IM q 28 days) in post-menopausal women with recurrent or metastatic ER+ breast cancer who are candidates for further hormonal therapy.

Detailed description: The majority of women diagnosed with breast cancer are post-menopausal, of which up to 75% are estrogen (ER) and/or progesterone receptor (PR) positive. Even in pre-menopausal breast cancer over half of all patients will have expression of these hormone receptors. Thus therapeutic strategies targeting the estrogen receptor or its ligand are the most common treatment offered in breast cancer. Despite substantial benefits now demonstrated with selective estrogen receptor modulators (e.g. tamoxifen) and aromatase inhibitors (e.g. anastrazole, letrozole and exemestane), a significant proportion of patients will still unfortunately have or develop resistance to these hormonal therapies.
  Despite approximately two-thirds of patients who are prescribed fulvestrant following prior hormonal agents not benefiting from this therapy, clinicians are still offering this option to all suitable women because of the lack of a better means of identifying the individual responders.
  To assess whether the recommended treatment is beneficial to a specific individual, the disease burden is assessed before and following treatment. Conventional imaging techniques such as the bone scan or computerized tomography (CT) can take several months to show a successful response to treatment. Positron emission tomography (PET) can improve the evaluation of women with breast cancer by providing an accurate assessment of the extent of disease and unique information about tumor biology such as metabolic activity.

Eligibility: Inclusion Criteria:
  -  post-menopausal (≥ 60 years old, or age ≥ 45 years with amenorrhea for > 12 months or follicle stimulating hormone and estrogen levels within post-menopausal range, or prior bilateral oophorectomy)
  -  hormone receptor positive (ER and/or PgR) disease as determined locally
  -  WHO performance status 0-2
  -  life expectancy of ≥ 3 months
  -  the presence of at least one measurable or evaluable (non-measurable) lesion
  -  informed consent prior to any study procedures
  Exclusion Criteria:
  -  life threatening metastatic visceral disease
  -  brain or leptomeningeal metastases
  -  prior exposure to fulvestrant
  -  history of bleeding diathesis or need for long term anti-coagulation

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: Water- and Salt-homeostasis in Healthy Humans, and in Patients With Heart- or Lung Disease

Summary: The purpose of the study is to determine whether the excretion of renal water- and salt-channels in the urine reflects the handling of water and salt in the kidneys, and whether the excretion can be used to monitor and/or predict the effects of treatment of certain heart or lung diseases.

Detailed description: The purpose of the study is to determine whether the excretion of renal water- and salt-channels (Aquaporin-2 and Epithelial Sodium Channels) in the urine accurately reflects the handling of water and salt in the distal tubules af the kidneys, and whether quantification of these channels in the urine is useful to monitor and/or predict the effects of pharmacologic or surgical treatment of Heart Failure and heart failure-related diseases (Aortic stenosis, acute and chronic ischemic heart disease or pulmonary hypertension)

Eligibility: Inclusion Criteria:
  -  Symptomatic heart failure
  -  Severe valvular aortic stenosis
  -  Acute Coronary Syndrome
  -  Medically refractory chronic angina pectoris or pulmonary hypertension with preserved left ventricular function
  Exclusion Criteria:
  -  Pregnancy
  -  Drug abuse
  -  Malignant disease
  -  Significant disease of other organs including endocrine diseases

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 Soluble Epoxide Hydrolase (s-EH) Inhibitor in Patients With Mild to Moderate Hypertension and Impaired Glucose Tolerance

Summary: The purpose of this study is to determine the safety and efficacy of AR9281, a novel s-EH enzyme inhibitor, in improving glucose metabolism and blood pressure in patients with impaired glucose tolerance and mild to moderate hypertension.


Eligibility: Inclusion Criteria:
  -  mild to moderate hypertension
  -  naive to antihypertensive medication or on two or less antihypertensive medications
  -  impaired glucose tolerance
  -  mild obesity
  Exclusion Criteria:
  -  Diagnosis of Type 1 or Type 2 diabetes
  -  History of severe heart failure
  -  AST, ALT levels more than twice the normal range

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: Pilot Study of a Self-help Intervention for Depression in Patients With a Chronic Disease

Summary: A feasibility pilot trial of the self-help, "Cognitive behavioural therapy" based "Living Life to the Full" Materials for use by patients with diabetes type 2 and / or coronary heart disease.

Detailed description: Depressed mood is common in patients with chronic disease and physical disability. It adversely affects quality of life, adherence to treatment and clinical outcome. Depression is expensive to the person, their family, employers and society. Recent developments in the UK General Practitioners' Contract mean that patients with two chronic diseases (Coronary Heart Disease- CHD and Diabetes − DM) are routinely screened for depression using a simple screening tool. We propose a study using an existing self help intervention in the specific context of patients with mild to moderately severe depression identified in this way.
  This RCT is the second phase of a 2 phase mixed methods study examining the feasibility of a Full RCT. The first involved focus group with patients and health practitioners.

Eligibility: Inclusion Criteria:
  -  Have had a diagnosis of diabetes mellitus type 2 and / or coronary heart disease.
  -  Be aged 35 or over.
  -  Be attending a participating primary care practice.
  -  Have a depression severity scale rating indicating moderate to moderately severe depression, such as:Prime-MD-PHQ9 of 10-21; HADS-D of 8-15;BDI-2 of 23-44
  Exclusion Criteria:
  -  Unable to provide informed consent to participate
  -  Already receiving psychological treatment for their depression
  -  Have commenced treatment with an SSRI within the past 8 weeks
  -  Likely to have difficulty communicating by telephone
  -  Likely to have difficulty completing the forms and questionnaires
  -  Have a serious physical disorder
  -  Have a serious mental disorder
  -  Express significant suicidal thoughts (PHQ9 or BDI-2 question 9 scoring >1)
  -  Took part in an earlier related focus group

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: Breast-Conserving Surgery Techniques in Treating Women With Breast Cancer

Summary: RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery.
  PURPOSE: This phase II trial is studying different breast-conserving surgery techniques in treating women with breast cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Evaluate the percentage of histologically healthy margins maintained during resection in women with breast cancer.
  Secondary
  -  Evaluate local recurrence at 5 years.
  -  Evaluate aesthetic results.
  -  Evaluate quality of life using the QLQC30 and BR23 questionnaires.
  OUTLINE: This is a multicenter study.
  Patients undergo oncoplastic conservative surgery according to defined modalities across the various centers.
  Quality of life is assessed periodically.
  After completion of study treatment, patients are followed every 6 months for 2 years and then for at least 3 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  Diagnosis of intraductal breast cancer requiring a wide local resection
  -  Diagnosis of infiltrating ductal breast cancer within range
  -  Diagnosis of invasive breast cancer that has not responded well to neoadjuvant treatment
  -  No multicentric tumor
  -  No gigantomastia
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  -  No patients subject to a measure of legal protection or unable to express consent
  -  No patients deprived of liberty by judicial or administrative decision or hospitalized without patient consent
  -  Not pregnant or nursing
  PRIOR CONCURRENT THERAPY:
  -  No prior radiotherapy to the diseased breast
  -  No prior adjuvant treatment
  -  No concurrent participation in another clinical research 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: Level of HER2-neu Gene Amplification an Response to Trastuzumab

Summary: Primary objective of the study is to evaluate the correlation between level of HER2-neu gene amplification evalued by dual-color Fluorescent in-situ hybridization (FISH) test and time to progression (TTP) in patients with HER2-positive advanced breast cancer treated with trastuzumab-containing regimens.


Eligibility: Inclusion Criteria:
  -  HER2-positive breast cancer Trastuzumab-containing regimen delivered for advanced disease Tumor sample available at Pathology Archive
  Exclusion Criteria:
  -  HER2-negative advanced breast cancer Pretreatment with trastuzumab

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: MRI in Assessing Tumor Size in Women With Ductal Carcinoma In Situ

Summary: RATIONALE: Diagnostic procedures, such as MRI, may help find ductal carcinoma in situ and find out how far the disease has spread.
  PURPOSE: This clinical trial is studying how well MRI works in assessing tumor size in women with ductal carcinoma in situ.

Detailed description: OBJECTIVES:
  Primary
  -  Assess the contribution of MRI in accurately determining tumor size in women with ductal breast carcinoma in situ (DCIS).
  Secondary
  -  Evaluate the sensitivity of MRI in detecting DCIS.
  -  Evaluate the contribution of mammography in accurately determining tumor size.
  -  Compare the contribution of MRI vs mammography in assessing tumor extension.
  -  Compare the contribution of MRI vs mammography in assessing dense breasts.
  -  Evaluate the morphology of DCIS by MRI.
  -  Evaluate the curve of dynamic MRI in assessing DCIS.
  -  Evaluate the impact of nuclear grade of DCIS by MRI.
  -  Evaluate the rate of revision surgery.
  OUTLINE: Patients undergo clinical examination, mammography, ultrasound imaging, unilateral breast MRI, and tissue sampling.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of ductal breast carcinoma in situ
  -  Any grade disease allowed
  -  Unifocal disease by mammography
  -  No history of breast cancer
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  -  WHO performance status 0-2
  -  Glomerular filtration rate ≥ 30 mL/min
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  -  No allergy or contraindication to contrast MRI
  -  No pacemaker or vascular clip
  PRIOR CONCURRENT THERAPY:
  -  No prior or concurrent liver transplantation

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: Biomarkers in Predicting Response to Tamoxifen and Letrozole in Postmenopausal Women With Primary Breast Cancer Treated on Clinical Trial CAN-NCIC-MA17

Summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients respond to treatment.
  PURPOSE: This laboratory study is looking at biomarkers that may predict response to tamoxifen and letrozole in postmenopausal women with primary breast cancer treated on clinical trial CAN-NCIC-MA17.

Detailed description: OBJECTIVES:
  -  Assess the prognostic utility of the MGH 2-gene and the GHI 21-gene expression signatures in postmenopausal women with primary breast cancer treated with tamoxifen followed by either placebo or letrozole on clinical trial CAN-NCIC-MA17.
  -  Assess the ability of the MGH 2-gene and the GHI 21-gene expression signatures to predict responsiveness to letrozole.
  -  Compare the prognostic utility of quantitative immunofluorescence vs standard immunohistochemistry of estrogen receptor, progesterone receptor, HER-2, tumor aromatase, cyclooxygenase-2, GATA-3, and NAT-1 in these patients.
  -  Assess the ability of quantitative immunofluorescence and standard immunohistochemistry of these proteins to predict responsiveness to letrozole in these patients.
  -  Use gene discovery from formalin-fixed, paraffin-embedded tumor specimens to identify novel gene expression profiles that may predict outcome and responsiveness to letrozole in these patients.
  OUTLINE: This is a controlled study.
  Formalin-fixed, paraffin-embedded breast tumor tissue samples are analyzed for MGH 2-gene and GHI 21-gene expression signatures using real-time quantitative polymerase chain reaction. Immunohistochemistry and immunofluorescence are used for analysis of estrogen receptor, progesterone receptor, HER-1 and -2, aromatase, GATA-3, NAT-1, and cyclooxygenase-2. Microarray hybridization is used to identify novel gene expression signatures.
  PROJECTED ACCRUAL: A total of 957 specimens will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed primary invasive breast carcinoma resected at time of original diagnosis
  -  Treated on clinical trial CAN-NCIC-MA17
  -  Hormone receptor status:
  -  Estrogen or progesterone receptor positive tumor
  PATIENT CHARACTERISTICS:
  -  Female
  -  Postmenopausal
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant