araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Treatment of Lung Adenocarcinoma With Bronchioloalveolar Feature

Summary: Pneumonic adenocarcinoma (P-ADC) is defined as a primary lung ADC with a radiological pneumonic presentation, usually referred to histologically as ADC with a mixed-invasive and BAC predominant subtype in the 2004 WHO classification. Surgery is the best therapy for resectable tumors since the effectiveness of chemotherapy is disappointing. In the advanced P-ADC diffuse/multifocal types of BAC, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) (gefitinib and erlotinib) have shown promise, with some rapid, dramatic responses, possibly reflecting specific molecular differences from other non-small cell lung carcinomas.

Detailed description: We therefore conducted a French multicentric phase II trial (IFCT 0401) to evaluate activity and tolerance of gefitinib (250 mg/day) administered as first line treatment in patients with non-resectable P-ADC.

Eligibility: Inclusion Criteria:
  -  Pathologically / cytologically proven ADC-P
  -  Non-resectable disease
  -  3-month expected survival
  -  No prior radiotherapy or chemotherapy
  -  Age >= 18 years old
  -  Performance status < 4 (WHO)
  -  Adequate blood biological parameters
  Exclusion Criteria:
  -  Abnormal initial fibroscopy

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103)

Summary: This is a randomized, active-control, double-blind study of subjects with stabilized high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN in the United States) compared with Simvastatin 40 mg. As per the original protocol, if low-density lipoprotein cholesterol (LDL-C) response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped). Clinical benefit will be defined as the reduction in the risk of the occurrence of the composite endpoint of cardiovascular (CV) death, major coronary events, and stroke.


Eligibility: Inclusion Criteria:
  -  Clinically stable participants may be eligible to enroll within 10 days following hospital admission with high-risk acute coronary syndrome (either ST-elevation myocardial infarction [STEMI] or Non-STEMI or unstable angina)
  -  Participants not taking a statin must have an LDL-C of 125 mg/dl or less. Participants taking a statin must have an LDL-C of 100 mg/dl or less.
  Exclusion Criteria:
  -  Pregnant or lactating woman, or intending to become pregnant
  -  Participant with active liver disease or persistent unexplained serum transaminase elevation
  -  History of alcohol or drug abuse
  -  History of sensitivity to statin or ezetimibe
  -  A participant for whom discontinuation of existing lipid lowering regimen poses an unacceptable risk.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Israeli 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation

Summary: The purpose of this study is to evaluate the safety and efficacy of the Aeris BLVR System in patients with advanced emphysema.

Detailed description: Emphysema is a progressive, debilitating disease that affects nearly 3 million people in the United States or roughly one percent of the US population. The disease is characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic and occupational causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death in the United States. Currently there are 46 million smokers in the US. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality in the United States for years to come.
  Aeris has developed a novel bronchoscopic system for achieving the benefits of lung volume reduction without surgery. The Bronchoscopic Lung Volume Reduction (BLVR) Hydrogel System, a new investigational therapy for emphysema, is intended to reduce lung volume over a period of weeks by collapsing and promoting the remodeling of diseased areas of the lung. The resulting reduction in lung volume is intended to restore a more normal physiological relationship between lung and chest wall, improve breathing and exercise capacity and alleviate symptoms of chronic dyspnea. The current study will evaluate the safety and efficacy of this procedure in patients with advanced emphysema.

Eligibility: Inclusion Criteria include:
  -  Clinical diagnosis of advanced heterogeneous emphysema
  -  Age > 18 years at the time of initial presentation
  -  Clinically significant dyspnea (MRC Dyspnea >/= 2)
  -  Failure of standard medical therapy to provide relief of symptoms
  -  BUN, creatinine, ALT, AST, alkaline phosphatase, WBC, hematocrit, platelet count, PT and PTT within normal limits
  -  Pulmonary function tests
  Exclusion Criteria:
  -  Alpha-1 protease inhibitor deficiency verified by a serum level of < 80 mg% or knowledge of PI*ZZ genotype
  -  Body mass index < 15 kg/m2 or > 35 kg/m2
  -  Clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis
  -  Tobacco use within 16 weeks of the initial clinic visit
  -  Allergy to fish or pork products or sensitivity to tetracycline
  -  FEV1 <20% with DLCO <20% or homogeneous disease

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Netherlands 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation

Summary: The purpose of this study is to determine the effective dose of the Aeris BLVR System in patients with advanced emphysema.

Detailed description: Emphysema is a progressive, debilitating disease that affects nearly 3 million people in the United States or roughly one percent of the US population. The disease is characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic and occupational causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death in the United States. Currently there are 46 million smokers in the US. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality in the United States for years to come.
  Aeris has developed a novel bronchoscopic system for achieving the benefits of lung volume reduction without surgery. The Bronchoscopic Lung Volume Reduction (BLVR) Hydrogel System, a new investigational therapy for emphysema, is intended to reduce lung volume over a period of weeks by collapsing and promoting the remodeling of diseased areas of the lung. The resulting reduction in lung volume is intended to restore a more normal physiological relationship between lung and chest wall, improve breathing and exercise capacity and alleviate symptoms of chronic dyspnea. This study will evaluate the safety and efficacy of the Aeris BLVR System in patients with advanced emphysema.

Eligibility: Inclusion Criteria include:
  -  Clinical diagnosis of advanced emphysema
  -  Age > 18 years at the time of initial presentation
  -  Clinically significant dyspnea (MRC Dyspnea >/= 2)
  -  Laboratory tests within protocol-specified ranges
  -  Pulmonary function tests
  Exclusion Criteria include:
  -  Alpha-1 protease inhibitor deficiency verified by a serum level of <80mg% or knowledge of PI*ZZ genotype
  -  Tobacco use within 16 weeks of the initial clinic visit
  -  Body mass index < 15 kg/m2 or > 35 kg/m2
  -  Clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis
  -  Allergy to fish or pork products or sensitivity to tetracycline
  -  FEV1 <20% predicted with DLCO <20% predicted or homogeneous disease

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Phase II Trial of Gleevec and Taxotere as a Combined Regimen for Advanced Gastric Adenocarcinoma

Summary: The purpose of this trial is to test the combination of Gleevec® (also known as imatinib mesylate) and Taxotere (also known as docetaxel) in patients with incurable stomach cancer. This study is being performed to see if the combination of Gleevec and Taxotere is an effective treatment for incurable stomach cancer with minimal side effects.

Detailed description: The purpose of this trial is to test the combination of Gleevec® (also known as imatinib mesylate) and Taxotere (also known as docetaxel) in patients with incurable stomach cancer. Gleevec is a pill form of chemotherapy and is indicated for the treatment of adult patients with chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). It is considered experimental for the treatment of stomach cancer. Taxotere (docetaxel) is a chemotherapy which is injected into the vein. It is approved for breast and lung cancer but has been shown to shrink many different types of tumors. Taxotere has been shown to shrink stomach cancer in about 20% - 30% of patients treated with Taxotere only. This study is being performed to see if the combination of Gleevec and Taxotere is an effective treatment for incurable stomach cancer with minimal side effects.
  Treatment on this study consists of two drugs, Gleevec® and Taxotere. Patients will be take four tablets of Gleevec® daily throughout the study. After one week of Gleevec®, patients will then begin receiving doses of Taxotere intravenously once a week for two weeks in a row followed by one week without Taxotere.

Eligibility: Inclusion Criteria:
  -  This study is for patients with histologically confirmed unresectable gastric adenocarcinoma and who have not received any chemotherapy other than 5-FU for adjuvant therapy either alone or in conjunction with radiation.
  Exclusion Criteria:
  -  Patients may not have received any chemotherapy agents other than 5-FU.
  -  Patients may not have received 5-FU for for therapy for metastatic gastric cancer.
  -  Patients must be more than 5 years free of another primary malignancy except: if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
  -  Patients must not have Grade III/IV cardiac problems, or any severe and/or uncontrolled medical disease (i.e. uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
  -  Patient must not have had previously received radiotherapy to >/= 25% of the bone marrow, or have had major surgery within 2 weeks prior to study entry
  -  Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome

Summary: This is a randomized, multi-center, open-label, parallel group study with three arms:
  -  Rasburicase alone
  -  Rasburicase followed by Allopurinol
  -  Allopurinol alone
  The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.

Detailed description: After signing the informed consent and having met the inclusion criteria, patients will be randomized to 1 of the 3 arms and treated for a total duration of 5 days. Patients in all arms will receive chemotherapy beginning 4-24 hours after the first dose of rasburicase or allopurinol.

Eligibility: Inclusion Criteria:
  1. Meets high risk or at potential risk for tumor lysis syndrome (TLS):
  A patient is at high risk for TLS if he/she presents with:
  -  Hyperuricemia of malignancy (plasma uric acid > 7.5 mg/dL);
  -  A diagnosis of very aggressive lymphoma/leukemia based on the Revised European-American Lymphoma (REAL) classification of lymphoma/leukemia;
  -  Acute myeloid leukemia (AML);
  -  Chronic myeloid leukemia (CML) in blast crisis; or
  -  High grade myelodysplastic syndrome (refractory anemia with excess blast, chronic myelomonocytic leukemia, and refractory anemia with excess blast in transformation) only if they have > 10% bone marrow blast involvement and are given aggressive treatment similar to AML.
  A patient is at potential risk for TLS if he/she presents with:
  -  A diagnosis of aggressive lymphoma/leukemia based on the REAL classification of lymphoma/leukemia plus 1 or more of the following criteria:
  -  Lactate dehydrogenase (LDH) >= 2 x upper limit of normal (ULN) (IU/L)
  -  Stage III-IV disease
  -  Stage I-II disease with at least 1 lymph node/tumor > 5 cm in diameter
  In addition to the above-mentioned eligibility criteria, the patients should have the following criteria:
  2. Eastern Cooperative Oncology Group (ECOG) performance status 0-3
  3. Age >= 18 years
  4. Life expectancy > 3 months
  5. Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (for both males and females). A pregnancy test may be performed on serum or urine human chorionic gonadotropin (HCG).
  6. Signed written informed consent

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Genetic Epidemiological Study of Lung Cancer in Taiwan and Clinical Applications

Summary: Lung adenocarcinoma in Chinese females is hypothesized to be determined by both genetic and environmental factors. In this grant proposal, we propose to map the loci of susceptibility genes of female lung adenocarcinoma based on multiplex families recruited in Taiwan. We focus on a unique pathological type of a unique population in order to reduce heterogeneity of the genetic background. Compared with western women, female Chinese population has a high prevalence of lung adenocarcinoma. Our reasoning is that if we focus on a specific sub-type, which has a familial basis, we will increase the probability of identifying genes associated with female lung adenocarcinoma. The primary goal of this study is to identify the genetic and environmental determinants of female lung adenocarcinoma, and study the relationship between gene polymorphisms and clinical manifestation profiling of lung cancer.

Detailed description: This research proposal intends to integrate epidemiologists, biostatisticians, clinicians, molecular biologists/geneticists to identify susceptible genes for lung cancer, especially for female lung adenocarcinoma, and to study the relationship between gene polymorphisms and clinical outcomes of lung cancer patients. Our objective is to find gene markers for developing useful screening tools for the high risk group in order to prevent or early detect lung cancer, especially female lung adenocarcinoma.
  The specific aims of this subproject include:
  1. Establish and maintain the research network that will recruit and follow up the subjects and families for the GEFLAC study; keeping control of the progress of the study.
  2. Coordinate all the subprojects such as integrating genotyping data with clinical data and environment data.
  3. Continue to employ the candidate gene approach to examine the contribution of specific genes to the lung cancer.
  4. Generate genotyping data for candidate genes in the exploring stage and prioritize SNPs of candidate genes for large scale studies.
  5. Identify susceptible genes/candidate genes to develop multiplex PCR for screening.

Eligibility: Inclusion Criteria:
  -  lung adenocarcinoma
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: Cerebrospinal Fluid Levels of Erlotinib in Patients Receiving Erlotinib For Stage III Non-Small Cell Lung Cancer

Summary: RATIONALE: Determining whether erlotinib passes into the cerebrospinal fluid may help in planning treatment for some types of cancer.
  PURPOSE: This clinical trial is studying how well erlotinib is able to pass into the cerebrospinal fluid of patients receiving erlotinib for stage III non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Determine the cerebrospinal fluid penetration of erlotinib in a subset of patients who are undergoing treatment with erlotinib for stage III non-small cell lung cancer and have no CNS metastatic disease.
  OUTLINE: This is a pilot, nonrandomized study.
  Patients will undergo single lumbar puncture (LP) to remove cerebrospinal fluid for analysis.
  After completion of study, patients will be monitored for 1 month after LP to assess for any LP-related complications.
  PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Patients must be enrolled in the trial: "A Phase I/II Trial of Neoadjuvant Paclitaxel, Carboplatin and OSI-774 (Tarceva) with Concurrent Accelerated Hyperfractionation Radiation Followed by Maintenance Therapy with OSI-774 for Stage III Non-Small Cell Lung Cancer," Principal Investigator: T. Mekhail, M.D.
  -  Patient must be in maintenance therapy phase of the study and have received erlotinib for ≥ 1 week
  -  No known CNS primary or metastatic cancer at any time prior to time of enrollment
  -  No MRI evidence of pathological enhancement at the time of study entry
  PATIENT CHARACTERISTICS:
  -  Patients must use adequate birth control measures while in the study
  -  No significant side effects to erlotinib that require dose reduction or interruption
  -  None of the following medical issues which could make a lumbar puncture unsafe:
  -  Platelets < 100,000/mm³
  -  INR > 1.1
  -  Known bleeding dyscrasia
  -  Absolute neutrophil count < 1,500/mm³
  -  Ongoing systemic bacterial infection
  PRIOR CONCURRENT THERAPY:
  -  Patients on modest or anti-epileptic therapy must be on nonenzyme-inducing drug only, including any of the following:
  -  Neurontin
  -  Lamictal
  -  Depakote, Depakene
  -  Felbatol
  -  Keppra
  -  Gabitril
  -  Topimax
  -  Zonegran
  -  No concurrent enzyme-inducing anti-epileptic drugs such as phenytoin, carbamazepine, or phenobarbital
  -  No concurrent other drug known to affect the metabolism of erlotinib
  -  No concurrent anticoagulant therapy

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study

Summary: The purpose of this study is to evaluate the safety of the Biologic Lung Volume Reduction System (BLVR) for patients with advanced emphysema.

Detailed description: Emphysema is a progressive, debilitating disease that affects nearly 3 million people in the United States or roughly one percent of the US population. The disease is characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic and occupational causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death in the United States. Currently there are 46 million smokers in the US. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality in the United States for years to come.
  Aeris has developed a novel bronchoscopic system for achieving the benefits of lung volume reduction without surgery. The Biologic Lung Volume Reduction (BLVR) System, a new investigational therapy for emphysema, is intended to reduce lung volume over a period of weeks by collapsing and promoting the remodeling of diseased areas of the lung. The resulting reduction in lung volume is intended to restore a more normal physiological relationship between lung and chest wall, improve breathing and exercise capacity and alleviate symptoms of chronic dyspnea. This study will evaluate the safety of the BLVR System in patients with advanced emphysema.

Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of advanced heterogeneous emphysema
  -  Age >/= 40
  -  Clinically significant dyspnea
  -  Failure of standard medical therapy to relieve symptoms
  -  Pulmonary function tests with protocol-specified ranges
  Exclusion Criteria:
  -  Alpha-1 protease inhibitor deficiency
  -  Tobacco use within 16 weeks of initial clinic visit
  -  Body mass index < 15 kg/m2 or > 35 kg/m@
  -  Clinically significant asthma, chronic bronchitis or bronchiectasis
  -  Allergy or sensitivity to tetracycline
  -  Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior endobronchial valve placement, prior airway stent placement or prior pleurodesis

Relevance to patient case: not relevant
Patient case: 48-year-old male with Lung adenocarcinoma. Genetic variant: MET Amplification. Other conditions: Emphysema.

Clinical trial: RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes

Summary: This study is a phase 3b, multicentre, randomised, open label, parallel group study. A 4-week run-in period will be followed by a median of 6 years of treatment with study medication in addition to continuation of background glucose lowering therapy. Patients inadequately controlled on background metformin will be randomised to receive, in addition to metformin, either rosiglitazone or a sulfonylurea(glibenclamide, gliclazide or glimepiride) in a ratio of 1:1. Patients inadequately controlled on background SU will be randomised to receive, in addition to SU, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of patients receiving background metformin and SU at entry will be entered into the study.

Detailed description: A RECORD follow-up study is being performed to monitor the incidence of cancer and bone fractures in RECORD patients for a period of 4 years after the end of the main RECORD study (2008 - 2012).

Eligibility: Inclusion Criteria:
  -  Patients with type II diabetes mellitus as defined by 1999 World Health Organisation criteria.
  -  Glycated haemoglobin (HbA1c) >7.0 % to = 9.0 % at visit 1.
  -  Use of an oral glucose lowering agent for a minimum of 6 months prior to screening and unchanged for 2 months prior to screening.
  -  Body mass index >25.0 kg/m2.
  Exclusion Criteria:
  -  Patients receiving any other glucose lowering therapy which is not metformin or a sulfonylurea.
  -  Patients with systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg.
  -  Patients who have required the use of insulin for glycaemic control at any time in the past.
  -  Hospitalisation for any major cardiovascular event in the last 3 months.

Relevance to patient case: not relevant