araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Tyrosine Kinase Inhibitors In Metastatic Non Small Cell Lung Cancer

Summary: Aim of the present retrospective study is to evaluate molecular factors of primary resistance to tyrosine kinase inhibitors in metastatic non small cell lung cancer (NSCLC) patients. The investigators assess first, the incidence of epidermal growth factor receptor (EGFR) and Kirsten ras sarcoma viral oncogene homolog (KRAS) mutations, SOS and hepatocyte growth factor (HGF) expression, anaplastic lymphoma kinase (ALK) translocation and expression and, secondly, the investigators correlate molecular markers with clinical features and outcome in terms of response rate, progression free survival and overall survival.

Detailed description: Non small cell lung cancer patients.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed diagnosis of NSCLC (non small cell lung cancer) with available tumor tissue for mutational analysis
  -  Metastatic disease treated with gefitinib or erlotinib
  -  Presence of at least one measurable lesion according to RECIST criteria
  Exclusion Criteria:
  -  No tumor tissue available
  -  No clinical data available

Relevance to patient case: possibly relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Observational Study on the Management of Patients With Non Small Cell Lung Cancer Adenocarcinoma

Summary: The main objective of the study is to determine the proportion of patients with M + mutation status among patients with Non Small Cell Lung Cancer adenocarcinoma.

Detailed description: MSD

Eligibility: Inclusion Criteria:
  -  Patient with lung cancer (Non Small Cell Lung Cancer adenocarcinoma)
  -  Patient for whom a search for the mutational status of EGFR (EGFR-M +, M- or Mx) has been done or is being analyzed
  Exclusion Criteria:
  -  Assessment of mutational status of EGFR is not done

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: AeriSeal® System for Lung Volume Reduction in Patients With Advanced Emphysema

Summary: The purpose of this study is to assess the procedural and post-procedural safety and efficacy of AeriSeal therapy at up to 4 subsegments during a single treatment session in patients with GOLD Stage III/IV homogeneous or heterogeneous emphysema.

Detailed description: Emphysema is a progressive, debilitating disease 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, occupational, and environmental 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 worldwide. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality for years to come.
  The AeriSeal System is a novel device system being developed for the treatment of advanced emphysema. The AeriSeal System is administered bronchoscopically, and designed to provide the physiological benefits of lung volume reduction without the risks and cost of major surgery.

Eligibility: Inclusion Criteria:
  -  Patients must have a diagnosis of advanced emphysema as defined by FEV1/FVC<70% predicted, FEV1 of <50% predicted, TLC > 100% predicted, and RV > 135% predicted.
  -  Patients must have persistent symptoms despite medical therapy and either not be candidates for Lung Volume Reduction Surgery (LVRS) or have elected not to undergo LVRS.
  -  Patients must be > 40 years of age, have symptoms despite medical therapy, and have none of the prespecified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-centre, Dose Ranging Study to Evaluate the Efficacy and Safety of Losmapimod Tablets Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD).

Summary: Randomised, double-blind, parallel-group, multi-centre study evaluating three doses of losmapimod (2.5mg, 7.5 mg and 15 mg) twice daily (BID) versus placebo on exercise tolerance. Eligible subjects will be randomised to treatment after a one-week run-in period. The duration of the treatment period is 24 weeks. An estimated 1000 subjects will be screened to reach the target enrolment of approximately 600 randomised subjects.


Eligibility: Inclusion Criteria:
  -  clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
  -  FEV1/FVC ratio of ≤0.70
  -  FEV1 ≤ 80% of predicted normal
  -  6MWD < 350m
  -  male or female outpatients aged ≥40 years of age
  -  current or prior history of ≥10 pack-years of cigarette smoking
  -  aspartate transaminase (AST) or alanine transaminase (ALT) <2x Upper Limit Normal (ULN)
  -  alkaline phosphatase (alk phos), and bilirubin <1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
  -  QTc <450 msec* on baseline ECG. For subjects with baseline complete bundle branch block, the QTc must be <480msec* on baseline ECG.
  Exclusion Criteria:
  -  current diagnosis of asthma
  -  pregnant or lactating
  -  α1-antitrypsin deficiency
  -  lung resection
  -  chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD
  -  exacerbation of COPD within previous 12 weeks
  -  treatment with roflumilast within previous 2 weeks and throughout the treatment period
  -  lower respiratory tract infection that required the use of antibiotics within previous 12 weeks
  -  long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day
  -  participation in the acute phase of a Pulmonary Rehabilitation Program within 12 weeks or planned during the study
  -  carcinoma that has not been in complete remission for at least 5 years
  -  current or chronic history of liver disease
  -  positive Hepatitis B surface antigen or positive Hepatitis C antibody
  -  Body Mass Index (BMI) > 35
  -  known or suspected history of alcohol or drug abuse within the last 2 years

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: A Safety and Efficacy Study of Farletuzumab in Subjects With Adenocarcinoma of the Lung

Summary: The primary objective of this study is to compare the effect of farletuzumab versus placebo in combination with either a platinum agent (carboplatin) with paclitaxel or a platinum agent (carboplatin or cisplatin) with pemetrexed followed by farletuzumab or placebo on investigator-assessed progression free survival (PFS) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 or definitive clinical disease progression (eg, new occurrence of positive fluid cytology) in chemotherapynaive participants with folate receptoralpha (FRA)-expressing Stage IV adenocarcinoma of the lung.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed adenocarcinoma of the lung classified as stage IV
  -  Confirmed folate receptor-alpha (FRA) expression by IHC
  -  Measurable disease with at least one unidimensionally measurable lesion according to RECIST criteria version 1.1 by CT or MRI scans (CT or MRI scans must have been performed within 30 days prior to the first dose of farletuzumab or placebo)
  -  Must have received no prior chemotherapy, radiation therapy or surgery with curative intent for adenocarcinoma of the lung
  Exclusion Criteria:
  -  Subjects who have had previous chemotherapy for adenocarcinoma of the lung
  -  Prior surgery with curative intent for adenocarcinoma of the lung
  -  Prior radiotherapy for adenocarcinoma of the lung. (Prior treatment with local radiotherapy for symptom control [i.e., palliative radiation with non-curative intent] is permitted)

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Evaluation of the PneumRx Lung Volume Reduction Coil to Treat Emphysema

Summary: The objective of this study is to demonstrate the safety of the PneumRx Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is a used as a less invasive alternative to lung volume reduction surgery. The PneumRx LVRC is designed as an alternative to lung volume reduction surgery, potentially achieving the desired reduction in lung volume limiting the risks associated with major surgery, such as illness or death. This device is deployed through a bronchoscope and requires no incision.


Eligibility: Inclusion Criteria:
  -  Patient > 35 years of age
  -  unilateral or bilateral emphysema
  -  Patient has stopped smoking for a minimum of 8 weeks
  -  Read, understood and signed the Informed Consent form
  Exclusion Criteria:
  -  Patient has a history of recurrent clinically significant respiratory infection
  -  Patient has an inability to walk >140 meters
  -  Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
  -  Patient is pregnant or lactating
  -  Patient has clinically significant bronchiectasis
  -  Patient has had previous LVR surgery, lung transplant or lobectomy
  -  Patient has been involved in other pulmonary drug studies with 30 days prior to this study
  -  Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: A Study of Cesium-131 Brachytherapy Following Sub-Lobar Resection for Early Stage Non Small Cell Lung Cancer

Summary: For patients diagnosed with early (Stage I) non-small cell lung cancer, a lobe of lung is usually removed at surgery to treat the cancer. For some patients, the removal of a lobe of lung may leave too little lung behind for easy breathing. For some of these patients, it may be possible to perform a smaller-scale surgery ("sub-lobar resection") and place a radioactive implant behind to prevent the cancer from growing back. This study will see how these patients do in terms of controlling their disease treated with a radioactive implant called Cesium-131.


Eligibility: Inclusion Criteria:
  1. Patients must have suspicious lung nodule for clinical stage I/recurrent non-small cell Lung Cancer
  2. Mass Tumor size < 7 cm
  3. Patient must have a CT scan of the chest with upper abdomen within 90 days prior to date of pre-registration.
  4. Patient must have ECOG/Zubrod performance status 0,1, or 2.
  Exclusion Criteria:
  1. Patient has already received high dose radiation to the area
  2. Cancerous nodule is very close to the esophagus or spinal cord, thereby increasing the risk of radiation treatment
  3. Pregnancy or unwillingness to practice a form of birth control (i.e. abstinence, oral contraceptives, etc.)

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Expression of Optic Atrophy Type 1 (OPA1) Protein in Lung Adenocarcinoma

Summary: Optic atrophy type 1(OPA1) is a nuclear dynamin-related GTPase, targeted to the inner mitochondrial membrane, which plays a role in mitochondrial fusion. Mitochondria fusion is associated with process of apoptosis. . OPA1 plays an important role in the mitochondrial bioenergetics and mitochondrial networks. The changes in mitochondrial shape and mitochondrial bioenergetics may be cause of the disease. In this study, we investigate the expression of OPA1 in lung adenocarcinoma (LADC) cells and tissue.


Eligibility: Inclusion Criteria:
  -  We will collect paraffin blocked resected lung tissue samples from stage I~IIIa non-small cell lung cancer patients (age, 40~80 years old) who received lobectomy of the affected lung.
  Exclusion Criteria:
  -  History of uremia, other malignant disease, and liver cirrhosis
  -  History of pneumonia and pulmonary tuberculosis
  -  History of long period of medications.

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Expression of AMP-activated Protein Kinase (AMPK) Protein in Lung Adenocarcinoma

Summary: AMP-activated protein kinase (AMPK) is an evolutionally conserved protein kinase that serves as an energy guardian to help cells adapt to various metabolic stress including hypoxia. Because the role of AMPK in cancers has not been fully elucidated, in this study we investigated the expression and activation of AMPK in lung adenocarcinoma (LADC) cells and tissue.


Eligibility: Inclusion Criteria:
  -  Lung cancer received operation lobectomy in CMUH
  Exclusion Criteria:
  -  History of uremia, other malignant disease, and liver cirrhosis
  -  History of pneumonia and pulmonary tuberculosis
  -  History of long period of medications.

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Research of the EML4-ALK Gene Expression in the Pleural Effusion or Tumor Tissue From Lung Cancer Patients

Summary: We wants to analyse the EML4-ALK mutation rate in the patients who have non-small cell lung cancer.


Eligibility: Inclusion Criteria:
  -  20 or more than 20 years of age
  -  The pathological diagnosis confirmed lung cancer
  -  Patients have achieved pleural effusion, or surgical biopsy to obtain tumor tissue specimens
  -  The patient had signed inform consent
  Exclusion Criteria:
  -  pleural effusion or tumor tissue can not be obtained
  -  the patient is not suitable to join the research according to the judgement by the investigator

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Molecular Determinants of Acquired Clinical Resistance to Crizotinib in Non-small Cell Lung Cancer Harboring a Translocation or Inversion Event Involving the ALK Gene Locus

Summary: The purpose of this study is to try to learn more about how small molecule kinase inhibitor medications work in treating lung cancer. Crizotinib (PF-02341066) is a drug that has been shown to shrink tumors in some patients with lung cancer. While the investigators know how this drug works to stop the growth of tumors that depend on change in the gene named ALK (also called EML4-ALK), the investigators do not know why the drug stops working. The investigators would like to examine the tumor to help us better understand why crizotinib has stopped working as well as it once did. The tumor will be examined with multiple tests to look for the reason that crizotinib stopped working.


Eligibility: Inclusion Criteria:
  -  ≥18 years of age
  -  Histologically proven diagnosis of NSCLC at MSKCC Tumor positive for a translocation or inversion event involving the ALK gene locus
  -  Clinical response to treatment with crizotinib as defined by either:
  Radiographic partial or complete response defined by RECIST or WHO
  OR:
  Radiographic stable disease for at least 8 weeks
  -  Radiographic progression of disease amenable to biopsy while on treatment with crizotinib as defined by RECIST or WHO
  -  Signed informed consent
  Exclusion Criteria:
  -  Deemed by their treating physician to be medically unfit for biopsy
  -  Women who are pregnant or breast-feeding

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Randomized Comparison of the RePneu Lung Volume Reduction Coil (LVRC) to Standard of Care for the Treatment of Emphysema (RESET Study)

Summary: The objective of this study is to demonstrate the safety and performance of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is used as a less invasive alternative to lung volume reduction surgery.


Eligibility: Inclusion Criteria:
  -  Patient greater than or equal to 35 years of age
  -  High resolution CT scan indicates unilateral or bilateral emphysema
  -  High resolution CT scan indicates homogeneous or heterogeneous emphysema
  -  Patient has post-bronchodilator FEV1 less than or equal to 45% predicted
  -  Total Lung Capacity greater than 100% predicted
  -  Patient has marked dyspnea scoring greater than or equal to 2 on mMRC scale of 0-4
  -  Patient has stopped smoking for a minimum of 8 weeks prior to entering the study
  -  Patient (and legal guardian if applicable) read, understood and signed the Informed Consent form
  Exclusion Criteria:
  -  Patient has a change in FEV1 greater than 20% post-bronchodilator
  -  Patients DLCO less than 20% predicted
  -  Patient has a history of recurrent clinically significant respiratory infection
  -  Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure greater than 50mm Hg and/or evidenced by echocardiogram
  -  Patient has an inability to walk greater than 140 meters (150 yards) in 6 minutes
  -  Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
  -  Patient is pregnant or lactating
  -  Patient has an inability to tolerate bronchoscopy under heavy sedation or anesthesia
  -  Patient has clinically significant bronchiectasis
  -  Patient has giant bullae greater than 1/3 lung volume
  -  Patient has had previous LVR surgery, lung transplant or lobectomy
  -  Patient has been involved in other pulmonary drug studies with 30 days prior to this study
  -  Patient is taking greater than 20 mg prednisone (or similar steroid) daily
  -  Patient is on Plavix or has not been weaned off prior to procedure
  -  Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency

Summary: Patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency might benefit from endoscopic implantation of intrabronchial valves.

Detailed description: Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 25 patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency. All patients will undergo treatment at one study centre in Heidelberg. Therapy of all patients consists of implantation of intrabronchial valves (IBV, Spiration, Olympus) in the most emphysematous destroyed lobe.

Eligibility: Inclusion Criteria:
  -  pulmonary function: FEV1 < 45 %, RV > 150 %, TLC > 100 %
  -  alpha1 antitrypsin deficiency (< 80 mg/dl), genotype: PiZS, PiZZ, Pi0/0
  -  heterogenous emphysema
  Exclusion Criteria:
  -  homogenous emphysema
  -  significant bronchiectasis
  -  severe concomitant diseases
  -  pregnancy

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Study of an Investigational Drug, ASP3026, in Patients With Solid Tumors

Summary: A study to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced malignancies (solid tumors).

Detailed description: This study will be conducted using a traditional 3 + 3 dose escalation study design. Enrollment of at least 3 subjects is planned for each dosing cohort. The decision to expand a cohort or dose escalate will be based on the occurrence of dose limiting toxicities (DLTs) in Cycle 1 that are considered by the Investigator to be related (possibly or probably) to ASP3026. The Safety Data Review Committee may elect to enroll additional subjects in a cohort to further evaluate the dose level. Each cycle will include 28 days of continuous dosing with ASP3026. Treatment with ASP3026 may continue until one of the discontinuation criteria is met.
  The maximum tolerated dose (MTD) is defined as the highest dose of ASP3026 on a dosing schedule at which < 33% of subjects experience a DLT during Cycle 1. The MTD or lower dose, as determined by the Safety Data Review Committee, will be the recommended Phase 2 dose (RP2D). Twelve additional patients will be treated at the RP2D to further evaluate safety and tolerability.

Eligibility: Inclusion Criteria:
  -  Eastern Cooperative Oncology Group (ECOG) performance status < 2.
  -  Histologically or cytologically confirmed diagnosis of a relapsed/refractory solid tumor
  -  Patient meets at least 1 of the following criteria:
  -  Disease progression despite standard therapies
  -  No standard therapies are available or such therapies are not anticipated to result in a durable response
  -  Standard therapies are considered unsuitable or have been refused
  -  Life expectancy > 12 weeks
  -  Able to be hospitalized from 1 day prior to the initial dosing until day 15 of the dosing, and from day 27 until day 29 of the dosing
  Exclusion Criteria:
  -  Patient exhibits persistent subjective and objective findings of toxicity ≥ Grade 2 (CTCAE v4.0-JCOG) from the previous cancer treatment with antitumor effect (except of alopecias)
  -  Received previous treatment with antitumor effect within 21 days prior to the scheduled initial dosing
  -  Patient had a major surgical procedure within 21 days prior to the scheduled initial dosing or a major surgical procedure scheduled during the course of the study
  -  Use of an investigational drug or device within 21 days prior to the scheduled initial dosing
  -  Use of blood transfusion or hematopoietic growth factors within 14 days prior to the scheduled initial dosing
  -  A positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV)
  -  Known history of a positive test for human immunodeficiency virus (HIV) infection
  -  Patient has central nervous system (CNS) or leptomeningeal involvement with clinical symptoms

Relevance to patient case: not relevant