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: Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure

Summary: Recently literature revealed facts, that show H+/K+ ATPase expression is not limited tot he stomach. H+/K+ ATPase was also found in smooth muscle cells and in other tissues (McCabe, R.D. et al., Am J Physiol. 1992). For myocard a localisation is only proven for rats yet (Beisvag, V. et al., Acta Physiol Scand. 2003). Moreover biochemical hints lead us to a highly probability of a myocardial H+/K+ ATPase (Nagashima, R. et al., Jpn Heart J. 1999).

Detailed description: Recently literature revealed facts, that show H+/K+ ATPase expression is not limited tot he stomach. H+/K+ ATPase was also found in smooth muscle cells and in other tissues (McCabe, R.D. et al., Am J Physiol. 1992). For myocard a localisation is only proven for rats yet (Beisvag, V. et al., Acta Physiol Scand. 2003). Moreover biochemical hints lead us to a highly probability of a myocardial H+/K+ ATPase (Nagashima, R. et al., Jpn Heart J. 1999). Aim of our clinical study is to examine, whether proton pump inhibitors have an influence on myocardial contraction of human myocard and we want to ascertain the amount of influence of a H+/K+ ATPase on myocardial contraction. Therefore the mechanism of a putative inhibition by proton pump inhibitors is at our focus. These findings will be of major credit regarding treatment of patients with congestive heart failure with common proton pump inhibitors. We want to find out, whether this intake may have a negative inotropic effect on the heart failure myocard.

Eligibility: Inclusion Criteria:
  1. Only patients older than 18 years. Range 18 to 80 years
  2. Only cooperative patients
  3. Only patients with a need for a coronary angiography, independently from our study
  4. Only patients with a left ventricular ejection fraction as demanded in the study protocol
  5. Only patients with clinical symptoms of congestive heart failure, corresponding to New York Heart Association stage NYHA II or III
  6. Only patients without oral or i.v. application of a proton pump inhibitor up to 48 hours prior to the study catheterization
  Exclusion Criteria:
  1. Manifest or severe accompanying diseases, despite of diabetes mellitus
  2. Intravascular or oral application of proton pump inhibitors within the last 48 hours
  3. Intake of Metformin within the last 24 hours
  4. Status post heart transplant
  5. Pregnancy
  6. Known intolerance of pantoprazole
  7. severe side effects of the tested substance pantoprazole, as well as pharmacokinetic interactions through CYP isoenzymes
  8. Existance of side effects as given in the pantoprazole drug information, among others disturbances of blood- and lymphatic system, leukopenia, thrombopenia, affections of gastrointestinal tract, nerve system affections, psychiatric affections, renal or bladder affections
  9. Participation in a other clinical trial

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: Combination Therapy With MYOCET® (Doxorubicin HCL Liposome for Injection) in Patients With HER2-Positive Breast Cancer

Summary: Evaluate the efficacy and safety of treatment with MYOCET® in combination with Cyclophosphamide and Trastuzumab, 4 cycles, followed by Docetaxel plus Trastuzumab, 4 cycles, in women with stage II or III breast cancer whose tumour overexpresses the HER2 gene.

Detailed description: A multicentre, open-label, randomized, Phase 2 study to evaluate the efficacy and safety of treatment with MYOCET® in combination with cyclophosphamide and trastuzumab versus free doxorubicin in combination with cyclophosphamide, each followed by docetaxel and trastuzumab, in women with stage II or III breast cancer whose tumour overexpresses the HER2 gene.

Eligibility: Main Inclusion Criteria:
  -  Treatment-naive patients with stage II or III invasive breast cancer (proven histologically/cytologically) and with tests showing an overexpressing of human epidermal growth factor receptor 2 (HER2).
  -  Patients have at least one bidimensionally measurable lesion according to the WHO criteria.
  -  The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  -  The patient has an LVEF of at least 55% as assessed by multiple-gated acquisition (MUGA) scan (preferred) or echocardiography.
  -  The patient has hematology and serum chemistry laboratory test results within specific protocol-defined ranges.
  -  Women of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the treatment period and for 6 months after the last administration of study drug.
  Main Exclusion Criteria:
  The patient:
  -  Has received previous cancer therapy for breast cancer.
  -  Has any history of CHF, angina pectoris, or myocardial infarction.
  -  Has uncontrolled hypertension.
  -  Has infection, peptic ulcer, or unstable diabetes mellitus.
  -  Has been treated with live virus vaccines within 8 weeks before the first administration of study drug.
  -  Has impaired hepatic or renal function.
  -  Is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
  -  Has used an investigational drug within one month before the screening visit.
  -  Has a known hypersensitivity to any of the study drugs or to their active ingredients.
  -  Has an inflammatory breast cancer.
  -  Has had any other malignancies within five years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin 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: Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer

Summary: The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess the effect of the combination on advanced breast cancer


Eligibility: Inclusion Criteria:
  -  Inoperable estrogen receptor positive and HER2 negative breast cancer.
  -  Postmenopausal status.
  -  Tumor tissue (archived acceptable) available for biomarker studies. For Phase 2 Part 2 - CCND1 amplification and/or loss of p16 as determined by the central laboratory.
  -  Acceptable bone marrow, liver and kidney function.
  Exclusion Criteria:
  -  Prior or concomitant treatment for advanced breast cancer.
  -  Other major cancer in the past 3 years.
  -  Important cardiovascular events in the past 6 months.

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: An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer (VIRGO)

Summary: This is a multicenter, prospective observational cohort study (OCS) designed to follow patients with locally recurrent or metastatic breast cancer in the United States. Two cohorts will be included:
  -  Patients with human epidermal growth factor receptor 2-negative (HER2-negative) disease receiving their first cytotoxic chemotherapy and/or targeted therapy (approximately 825 patients)
  -  Patients with hormone receptor-positive (HR-positive) disease receiving their first hormonal therapy for advanced disease (approximately 425 patients)
  Patients who have received any chemotherapy for advanced disease more than 8 weeks prior to enrollment to this OCS will not be eligible. A total of approximately 1,250 patients will be enrolled. Approximately 150 study sites will be activated in order to achieve complete enrollment by December 2010.


Eligibility: Inclusion Criteria:
  -  Signed Informed Consent Form
  -  Locally recurrent or metastatic breast cancer
  -  Receipt of first systemic cytotoxic chemotherapy and/or targeted therapy among those with HER2-negative disease or first hormone therapy among those with HR-positive disease for the treatment of locally recurrent or metastatic disease, within 8 weeks prior to enrollment
  Exclusion Criteria
  -  Any medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to provide informed consent or comply with the treatment
  -  Any prior chemotherapy started more than 8 weeks prior to enrollment for the treatment of locally recurrent or for metastatic breast cancer
  -  Concurrent participation only in a blinded clinical trial

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: A Study to Evaluate Safety and Tolerability in Patients With Metastatic Breast Cancer Receiving Treatment With Caelyx (Study P04878)(COMPLETED)

Summary: This is a study to evaluate the safety and tolerability of Caelyx used for the treatment of metastatic breast cancer (MBC), focusing on infusion reaction and palmar-plantar erythrodysesthesia (PPE).

Detailed description: Patients selected by investigator according to clinical routine

Eligibility: Inclusion Criteria:
  -  Patients with metastatic breast cancer
  Exclusion Criteria:
  -  History of hypersensitivity to Caelyx or its components
  -  Women who are pregnant or breast-feeding
  -  Patients with severe myelosuppression

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: Chronic Pain After Operation for Breast Cancer

Summary: The purpose of this study is to identify intraindividual as well as iatrogenic factors disposing for the development of chronic and acute pains after surgery for breast cancer in order to improve treatment and prevent the development of acute and chronic postoperative pains.

Detailed description: Surgery for breast cancer is followed by acute undesirable sequelae (pain, nausea, vomiting, psycho-social adaptation) and late sequelae with discomfort or more severe neuropathic pain problems in the surgical area due to nerve damage or adjuvant-/radiotherapy. The late sequelae occur in 30-50% of patients but the exact mechanisms (preoperative disposing factors, intraoperative nerve damage/inflammatory response), acute postoperative pain and psychosocial factors remain to be determined in large, detailed, well-described studies, including stratification to modern breast cancer treatment (sentinel node strategy/ radiotherapy/ chemotherapy). The present study will describe in detail preoperative psychosocial/genetic pain mechanisms, intraoperative technique, multi-modal anaesthesia and opioid-reduced analgesia with a detailed, early and late postoperative follow-up with neurophysiological assessment in the surgical area and randomised studies on preventive therapy.

Eligibility: Inclusion Criteria:
  -  Healthy women
  Exclusion Criteria:
  -  Pregnancy
  -  Lactating

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 Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients

Summary: Aim of the study is to assess the impact on response to Herceptin-based therapy in patients with advanced breast cancer. Tumor specimens from primary breast cancer will be analized for several biological factors potentially involved in Herceptin sensitivity.
  Tests that will be performed include: FISH analyses of EGFR, HER-2, HER-3, C-MYC, PTEN, MET, IGFR-1. Immunofluorecence of P95HER2. Mutation analyses of EGFR, HER-2, MET, C-MYC, PTEN, KRAS, PIK3CA, IGFR-1. Immunohistochemistry of the same biomarkers.


Eligibility: Inclusion Criteria:
  -  Hystological diagnosis of breast cancer
  -  Availability of tumor tissue
  -  Availability to assess the response to Trastuzumab according to RECIST criteria
  -  Availability of clinical data
  Exclusion Criteria:
  -  Unavailability of tumor tissue
  -  Impossibility to assess the response to Trastuzumab according to RECIST criteria

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

Clinical trial: Thiamine Supplementation to Improve Cardiac Function in Patients With Congestive Heart Failure

Summary: Working Hypothesis: a treatment with thiamine improves functional status and heart function of patients with congestive heart failure when on a diuretic treatment.

Detailed description: In the treatment of congestive heart failure, diuretic drugs have become a firm cornerstone of therapy. Up to 50% of patients with congestive heart failure in industrialized nations will undergo long-term diuretic treatment. Diuretic therapy is associated with a loss of water soluble vitamins, including vitamin B1 (thiamine). Electrolyte dysbalance, a major side effect of diuretic therapy, has been extensively studied. In sharp contrast, only few data are available about the effects of vitamin loss and in particular of thiamine in this setting. Available data suggest that a diuretic treatment is associated with an increased risk for thiamine deficiency. Thiamine plays a crucial role for normal cardiac function, since severe thiamine deficiency leads to congestive heart failure (wet beriberi). Consequently, patients undergoing diuretic treatment might have compromised heart function. Supplementation of thiamine has been reported to improve cardiac function in patients with congestive heart failure on long-term treatment with diuretic drugs. However, no efforts have been made to confirm those preliminary observations by a placebo-controlled, double-blind study.

Eligibility: Inclusion Criteria:
  -  Patients with stable congestive heart failure on a prescription for diuretic drugs
  Exclusion Criteria:
  -  Acute heart failure
  -  Foreseeable need for further changes in medication
  -  Current medication containing vitamins
  -  Patients with a creatinine above 250 μmol/l

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: 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: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

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: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Chemotherapy Monitoring With Breast Computed Tomography (CT)

Summary: The purpose of this study is to determine if dedicated breast computed tomography can be used successfully to monitor tumor response in breast cancer patients undergoing neoadjuvant chemotherapy.

Detailed description: Before undergoing surgery to remove the tumor, it is common for breast cancer patients to first undergo chemotherapy or hormonal therapy. The main goal of the therapy is to reduce the size of the tumor before it is removed. Unfortunately, therapy response varies a lot between patients. The development of an effective therapy response monitoring method could reduce the time that a patient undergoes ineffectual therapy or unnecessary therapy after complete response.
  Dedicated breast computed tomography (or breast CT), a new way of imaging the breast, has been introduced in the last few years. Breast CT is an x-ray exam that uses 3D imaging to show the breast in its real three dimensional shape. Combined with the use of special chemicals called iodine contrast enhancement, breast CT can provide images of both the anatomy and the blood flow in the breast. We propose to use breast CT to carefully monitor the response to therapy of breast cancer patients undergoing therapy before surgery.

Eligibility: 3.1 Eligibility Criteria
  -  All subjects will be women at least 18 years of age that will undergo standard or research pre-operative hormonal therapy for breast cancer before lumpectomy or mastectomy.
  -  Women who have undergone pre treatment breast MR imaging to verify that no additional findings are present.
  3.2 Ineligibility Criteria
  -  Subject does not meet any of the inclusion criteria
  -  Women with suspected or confirmed pregnancy
  -  Women who have had bilateral mastectomy
  -  Women who are unable to remain in a prone position on the BCT system for the required amount of time
  -  Women who cannot give informed consent
  -  Women with metastasis
  -  Male subjects
  -  Women with implants
  -  Women with breast augmentation, except for unilateral augmentation done for prior mastectomy
  -  Women who are allergic to iodine
  -  Women with physical limitations such as, but not limited to: frozen shoulder, recent heart surgery, pace maker, neck problems or any other condition that would prohibit them from lying face down
  -  Women who have had problems or reactions to contrast, such as nausea/vomiting, itching, hives, B/P changes, respirator distress, cardiac arrest.
  -  Women with history of Diabetes, kidney disease, kidney surgery, dialysis, heart disease-such as Congestive Heart Failure, Multiple Myeloma, Sickle Cell Anemia, Lupus, Rheumatoid Arthritis or other Autoimmune disease, recent surgery, chemotherapy, dehydration, high use of NSAIDs such as Ibuprofen

Relevance to patient case: not relevant