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

Clinical trial: Thorax Enlarging Surgery: a Novel Surgical Approach to Emphysema

Summary: There is a growing population of end-stage COPD patients for whom surgical treatments like lung transplantation and lung volume reduction surgery are not possible. In such patients, size mismatch between large emphysematous lungs and a restricted chest wall is a major cause for the reduction of dynamic lung volumes and consequent dyspnea. We hypothesized that enlargement of the thorax would be a potential alternative strategy to volume reduction surgery as it may improve lung mechanics by resizing the chest to the lung and does not further deprive patients from lung tissue which is already scarce.

Detailed description: Lung volume reduction surgery primarily increases vital capacity by reducing RV more than TLC. As the chest wall is the major TLC limiting factor, an alternative approach that could circumvent size mismatch would be a surgical enlargement of the thorax cavity. Any post-operative increase of TLC would allow greater dynamic operational lung volumes to occur with an equal amount of dead space. Moreover, resizing of the thorax would have a tremendous advantage over resizing of the lung, in that it would not require resection of the lung in patients in whom lung tissue is already scarce. Chest expansion will only be guaranteed if the sternal widening osteotomy will obtain a solid union. Small poly-ether-ether-keton (PEEK) cages were designed to match both sternal halves in a 'press fit' way, which were filled with lyophilised bone and fixed with extra wires as in a classical sternotomy. These bone-filled cages function as a perfect matrix for progressive in-growth of cancellous bone.

Eligibility: Inclusion Criteria:
  patients with end-stage emphysema and
  -  Disabling dyspnea
  -  GOLD III or IV
  -  Residual volume > 200% predicted
  -  Total Lung capacity > 120% predicted
  -  RV/TLC > 0.6
  -  Resting CO2 < 50 mmHg
  -  diffusion capacity > 20% predicted
  -  age < 70 years
  Exclusion Criteria:
  -  previous sternotomy
  -  contraindication of general anesthesia
  -  chronic treatment with corticosteroids
  -  any tobacco use within 6 months
  -  candidates for lung volume reduction surgery or lung transplantation

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

Clinical trial: Evaluating the Effects of Surgical and Non-Surgical Treatment Options in People With Emphysema

Summary: Emphysema is a lung disease that involves damage to the air sacs in the lungs and can lead to breathing difficulties. Treatment options for people with emphysema include pulmonary rehabilitation, lung volume reduction surgery, and lung transplantation. This study will observe people with emphysema to assess the effect of these treatment therapies on their quality of life and long-term health.

Detailed description: Emphysema is a progressive lung disease that results in shortness of breath and a reduced capacity for physical activity. It is caused by inflammation within the small air sacs and small airways of the lungs, which can lead to the destruction of the air sac walls and eventually to airway collapse. Treatment options for emphysema include both non-surgical and surgical interventions. Pulmonary rehabilitation, a non-surgical treatment, includes a combination of education, exercise training, nutrition advice, and smoking cessation programs. The goal of pulmonary rehabilitation is to increase exercise tolerance and reduce breathing difficulties. Two surgical treatment options include lung volume reduction surgery, in which small amounts of damaged lung tissue are removed, and lung transplantation, in which a person's damaged lung is replaced with a healthy lung from a donor. While these surgical options may offer potential improvements in quality of life, they also impose substantial risks, including infections, pneumonia, or even death. In this study, researchers will follow participants over a long period of time to assess the effects of pulmonary rehabilitation, lung volume reduction surgery, and lung transplantation on health outcomes and quality of life.
  This study will enroll people with moderate to severe emphysema who have undergone pulmonary rehabilitation, lung volume reduction surgery, or lung transplantation. Participants will attend annual study visits and will complete computerized interviews and health-related questionnaires that will assess quality of life factors. Study researchers will also review participants' medical records to collect information on lung function and blood test results.

Eligibility: Inclusion Criteria:
  -  Diagnosed with emphysema
  -  Referred for pulmonary rehabilitation, lung volume reduction surgery, or lung transplantation
  Exclusion Criteria:
  -  Non-obstructive lung disease
  -  Chronic obstructive pulmonary disease (COPD) that is not predominantly due to emphysema
  -  Inability to read English

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

Clinical trial: Safety and Feasibility Study of the Chartis System With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)

Summary: The purpose of this study is to evaluate the safety and feasibility of the Chartis System in measuring air flow and pressures in isolated lung compartments in emphysema patients prior to endobronchial lung volume reduction (ELVR).


Eligibility: Inclusion Criteria:
  -  Heterogeneous emphysema as determined by high-resolution CT scan
  -  Scheduled for clinically indicated ELVR procedure
  Exclusion Criteria:
  -  Hyperexcretive chronic bronchitis or excessive sputum secretion
  -  Active pulmonary infection
  -  Active asthma or lung hyper-responsiveness

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

Clinical trial: Serum, Plasma, DNA and Tissue Bank in Chronic Obstructive Pulmonary Disease and Lung Cancer

Summary: A biobank of Serum, plasma, DNA samples together with clinical information including specific questionnaires, complete pulmonary function and chest CT-scan, is prospectively collected in patients seen at the investigators' clinical service.
  The objective is to study candidate gene pathways in COPD and or lung cancer and to associate them with the clinical characteristics and phenotypes of COPD/emphysema and lung cancer.
  In subgroups of well characterised patients, other biological materials are also collected (lung tissue biopsies, peripheral blood mononuclear cells).

Detailed description: All patients with a smoking history of at least 15 pack years, an minimal age of 50 years and an recent available CT scan are enrolled.
  All subjects with a diagnosis of lung cancer are also collected (irrespective of age and smoking behavior).
  In addition the investigators collect:
  -  specific questionnaires (MRC, CCQ and smoking history)
  -  medical and professional history
  -  complete pulmonary function (spirometry, bodyplethysmography and diffusing capacity)
  -  serum, plasma and DNA samples.
  In specific subgroups the investigators also collect:
  -  Peripheral blood mononuclear cells
  -  Lung tissue - if available - from a surgical procedure (lung transplantation or lobectomy)

Eligibility: Inclusion Criteria for smokers:
  -  A smoking history of at least 15 pack years and age of 50 years or older
  -  Complete pulmonary function on day of visit
  -  Chest CT-scan within one year of enrollment
  -  4 weeks from exacerbation
  Exclusion Criteria for smokers:
  -  Less than 15 pack years
  -  Younger than 50 year
  -  Other pulmonary diseases interfering with CT or pulmonary function
  -  Asthma
  Inclusion Criteria for lung cancer patients:
  -  new diagnosis of proven lung cancer
  -  chest CT scan within 2 months of enrollment
  -  Complete pulmonary function
  Exclusion Criteria for lung cancer patients
  -  not able to perform pulmonary function
  -  Absence of histological diagnosis of lung cancer

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

Clinical trial: Individualized Treatment Based on Epidermal Growth Factor Receptor Mutations and Level of BRCA1 Expression in Advanced Adenocarcinoma

Summary: This is a pharmacogenic, prospective, and multicenter study in patients with advanced lung adenocarcinoma.

Detailed description: Pharmacogenomic study, prospective, multicenter. Individualized treatment based on EGFR mutations and level of BRCA1 expression in patients with advanced lung adenocarcinoma

Eligibility: Inclusion Criteria:
  -  Patients age 18 years or more.
  -  Histologically confirmed diagnosis of non-small-cell lung carcinoma.(and indifferentiated and BAC histology).
  -  Only patients with advanced disease, defined as stage IV or IIIB with/without pleural effusion, will be included.
  -  Tumor sample available.
  -  A measurable lesion, as defined by RECIST criteria.
  -  Karnofsky score 60% or more (ECOG < 2).
  -  Patients should not have received previous treatment with chemotherapy or other agents for disseminated disease. Chemotherapy is allowed if the initial diagnosis of the patient is limited disease and the patient has received adjuvant or neoadjuvant treatment.
  -  Patients with cerebral disease are permitted, without any time limitations after holocranial irradiation or complementary antiedema treatment.
  -  Patients with hepatical, renal and hematology normality values.
  -  Patients should sign an informed consent form before inclusion in the study that specifies that the clinical trial treatment entails consent for the analysis of biological samples of tumor and blood.
  -  Patients of childbearing age of either sex must use effective contraceptive methods (barrier methods or other birth control methods) before entering the study and while participating in the study.
  -  Patients must be available for clinical follow-up..
  Exclusion Criteria:
  -  Patients who have received an investigational medicinal product in the 21 days before inclusion in the study or antiEGFR receptor agent.
  -  Severe comorbidity.

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

Clinical trial: Development of a Model to Predict Progression-Free Survival After Erlotinib in Patients With Non-Small Cell Lung Cancer

Summary: RATIONALE: Studying samples of 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 patients respond to treatment with erlotinib.
  PURPOSE: This laboratory study is developing a model to predict progression-free survival after erlotinib in patients with non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Assess mesenchymal and epithelial markers in tissues from patients with non-small cell lung cancer treated with erlotinib hydrochloride on clinical trial ECOG-E3503.
  -  Determine the loss of epithelial markers (E-cadherin) and gain of mesenchymal markers (vimentin/cytokeratin co-expression) in these patients.
  -  Assess whether mesenchymal and epithelial markers are predictive of progression-free survival (PFS) of these patients.
  -  Identify a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS of these patients.
  OUTLINE: Tissue samples are analyzed by whole genome mapping for single nucleotide polymorphism (SNP) rate and by signal detection rate and by quantitative immunohistochemistry for mesenchymal (vimentin/cytokeratin) and epithelial (E-cadherin) marker transitions. After biomarker identification and gene mapping are complete, a model to predict progression-free survival in these patients is developed.
  PROJECTED ACCRUAL: A total of 137 samples will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of non-small cell lung cancer, including any of the following subtypes:
  -  Adenocarcinoma
  -  Squamous cell carcinoma
  -  Bronchoalveolar carcinoma
  -  Carcinoid
  -  Stage IIIB or IV or recurrent disease
  -  Must have received treatment with erlotinib hydrochloride on clinical trial ECOG-E3503
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

Summary: This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.


Eligibility: Inclusion Criteria:
  -  histologically or cytologically proven diagnosis of non-small cell lung cancer
  -  positive for the ALK fusion gene (test provided by either a central laboratory. Local laboratory may be used for certain cases)
  -  may have received pemetrexed or docetaxel from previous Phase 3 trial (A8081007) and discontinued treatment due to Response Evaluation Criterion in Solid Tumors (RECIST)-defined progression. or, once the primary endpoint of Study A8081007 has been analyzed and the results made available, at any time without RECIST-defined progression.
  -  Tumors can be measurable or non measurable
  Exclusion Criteria:
  -  prior treatment with PF-02341066
  -  received no prior systemic treatment, chemotherapy or EGFR tyrosine kinase inhibitor, for advanced non-small cell lung cancer
  -  current enrollment in another therapeutic clinical trial

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

Clinical trial: An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

Summary: This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.


Eligibility: Inclusion Criteria:
  -  histologically or cytologically proven diagnosis of non-small cell lung cancer
  -  positive for the ALK fusion gene (test provided by a central laboratory)
  -  must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum drug
  -  tumors must be measurable
  Exclusion Criteria:
  -  prior treatment with PF-02341066
  -  current treatment in another clinical trial

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

Clinical trial: Ultra Structure Of Peritoneum At Electronic Microscopy In Control Subjects And Patients With Gastric Cancer

Summary: Peritoneal metastases appear in a great proportion of patients affected by gastric carcinoma. Involved mechanisms are poorly understood though experimentally it has been demonstrated that neoplastic cells exfoliated from primary tumor can only implant and proliferate in areas of damaged peritoneum. Objectives: to study ultra-structure of peritoneal surface by electronic microscopy in control subjects and in patients with early or locally advanced gastric cancer looking for spontaneous changes in peritoneal surface not related with surgical injury.

Detailed description: 18 out of 32 cases were eligible for analysis. Four patients operated on for benign diseases served as control and 14 patients with operable local gastric adenocarcinoma (4 mucosa/submucosa/muscular y 10 serosa lesions) were studied. At the beginning of surgery, a 2 x 2 cm. sample from macroscopically normal visceral peritoneum at mesenterium root was carefully obtained, washed with saline and fixed in glutaraldehyde solution. Besides a sample of peritoneal washing fluid was studied to exclude patients with free cancer cells. Peritoneal tissue was fixed during 24 hours and then all samples were evaluated by electronic microscope.

Eligibility: Inclusion Criteria:
  -  patients with operable local gastric adenocarcinoma
  Exclusion Criteria:
  -  previous abdominal surgery
  -  previous open or blunt abdominal trauma
  -  history of inflammatory bowel disease or Typhoid Fever, Gallstone disease, chemotherapy or radiotherapy, or any other abdominal condition that could alter peritoneal integrity.
  -  All other gastric malignancies such as lymphomas, GIST, carcinoids

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

Clinical trial: TS Gene Polymorphism Predicts Effect in Patients With Advanced Lung Cancer

Summary: The investigators performed a multicenter, open trial of using TS gene polymorphism to predict advanced lung adenocarcinoma effect to pemetrexed combined with cisplatin regiment as first-line treatment.

Detailed description: 1. Main eligibility criteria were histologic or cytologic proof of advanced non-small-cell lung cancer (NSCLC) primary treatment, normal organ function, and Eastern Cooperative Oncology Group performance status 0 to 2.
  2. All Patients were delivered to pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 for not less than 4 cycle, administered intravenously every 3 weeks. Response assessment was performed every 6 weeks; toxicity assessment was performed every 3 weeks.
  3. Primary end point was time to progression (TTP); secondary end points were objective response rate (ORR), overall survival (OS), and toxicity.
  4. The study was designed to evaluate TS(thymidylate synthase) gene polymorphism as a predictor for advanced lung adenocarcinoma effect to pemetrexed combined with cisplatin regiment as first-line treatment.
  5. Polymorphisms of thymidylate synthase were investigated in peripheral WBC（white blood cell）of all patients.

Eligibility: Inclusion Criteria:
  -  histologic or cytologic proof of advanced lung adenocarcinoma
  -  primary treatment
  -  normal organ function
  -  Eastern Cooperative Oncology Group performance status 0 to 2
  Exclusion Criteria:
  -  Symptomatic patients with brain metastases
  -  Major organ dysfunction and severe heart disease

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

Clinical trial: Positron Emission Tomography and Computed Tomography in Planning Treatment for Patients Undergoing 3-Dimensional Conformal Radiation Therapy for Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery. ICORG 06-35

Summary: RATIONALE: Diagnostic procedures, such as positron emission tomography and computed tomography, may help learn the extent of disease and allow doctors to plan 3-dimensional conformal radiation therapy.
  PURPOSE: This phase II trial is studying the side effects of positron emission tomography and computed tomography and to see how well it works in planning treatment for patients undergoing 3-dimensional conformal radiation therapy for non-small cell lung cancer that cannot be removed by surgery.
  This is a clinical study, as the patient will be treated using the PET-CT-GTV: - The pilot study is investigating the technological feasibility - The Phase II study will be a 2-stage Phase II study

Detailed description: Pilot Study- Primary Objectives:
  -  Prospective evaluation of the technical feasibility of integrating PET-CT fusion in St Luke's Hospital
  -  Rate of PET-CT Scan based treatment delivery
  Pilot Study- Secondary Objectives:
  -Comparison of GTV, PTV and OAR DVHs between conventional 3-DCRT plan and PET-CT based 3-DCRT plan.
  Phase II Study- Primary Objective:
  -The safety of PET-CT scan based radiotherapy, with regard to loco-regional disease control.
  Phase II Study- Secondary Objectives:
  -Comparison of GTV, PTV and OAR DVHs between conventional 3-DCRT plan and PET-CT based 3-DCRT plan.

Eligibility: Inclusion Criteria:
  -  Histologically proven (biopsy or cytology) NSCLC (SCC, Adenocarcinoma, Large Cell)
  -  TNM clinical non-operable stage I/II and non-resectable stage IIIa/b without pleural effusion
  -  Measurable disease
  -  No other malignancy, except non-melanomatous skin cancer, within 5 years prior to participation in this study; the disease-free interval from any prior carcinoma must be continuous
  -  Patient suitable for radical 3-DCRT
  -  ECOG-Performance status ≤ 2 / KPS > or equal to 60
  -  Weight loss <10% within the 3 months prior to diagnosis
  -  No prior radiotherapy to the thorax
  -  Patient is suitable for lung-board immobilisation
  -  No chemotherapy received prior to planning PET-CT scan
  -  Age 18 and over
  -  Provision of written informed consent
  Exclusion Criteria:
  -  Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial or if it is felt by the research / medical team that the patient may not be able to comply with the protocol.
  -  FEV1 < 1

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

Clinical trial: Unilateral Versus Bilateral Endoscopic Lung Volume Reduction A Comparative Case Study

Summary: Patients with bilateral heterogeneous pulmonary emphysema benefit to differing degrees from unilateral ELVR with complete lobe closure in comparison with incomplete bilateral treatment.

Detailed description: Patient enrolment and data acquisition is to be carried out on a prospective basis. It is planned to enrol a total of 20 patients with bilateral heterogeneous pulmonary emphysema. All patients will undergo treatment at one study centre in Heidelberg. Patients will be considered for both unilateral and bilateral treatment with intrabronchial valves (IBV) on the basis of their emphysema distribution. Patients will be randomised to two treatment arms. 10 patients receive unilateral or bilateral treatment in each case.

Eligibility: Inclusion Criteria:
  -  age > 40 inhomogeneous emphysema FEV1 between 20-40% DLCO between 20-40% 6MWT > 150 m
  Exclusion Criteria:
  -  pregnant homogeneous disease FEV1 < 20%

Relevance to patient case: not relevant