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

Clinical trial: Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study)

Summary: The purpose of this research is to study an investigational medical device that is designed to produce lung volume reduction in diseased areas of the lungs in patients with severe emphysema.

Detailed description: The Pulmonx Zephyr Endobronchial Valve (EBV) is an implantable bronchial valve intended to decrease volume in targeted regions of the lung. It is indicated for the treatment of patients with severe emphysema. The EBV are placed in the diseased region of the lung using bronchoscopy. Bronchoscopy is a way to access the lungs using a small tube with a camera on the end. As the diseased region of the lung shrinks in size, healthier regions may expand and function more efficiently, resulting in improved breathing.
  The LIBERATE Study is a clinical trial with two groups. Participants are assigned at random to the 'Treatment' group or to the 'Control' group. The 'Treatment' group will receive the Zephyr Endobronchial Valve (EBV) in combination with optimal medical therapy. The 'Control' group will receive optimal medical therapy alone. For every three participants in the study, two will go into the 'Treatment' group and one will go into the 'Control' group.
  It is hypothesized that after placement of the EBV, lung function will be improved as compared to standard medical therapy alone.

Eligibility: Inclusion Criteria:
  -  Clinical and radiological evidence of emphysema
  -  Nonsmoking for 4 months prior to screening interview
  -  BMI less than 35 kg/m2
  -  Stable on current medication regimen
  -  Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value
  Exclusion Criteria:
  -  Had two or more hospitalizations over the last year for a COPD exacerbation
  -  Had two or more hospitalizations over the last year for pneumonia
  -  Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy
  -  Had a heart attack or congestive heart failure within the last 6 months
  -  Have heart arrhythmia
  -  Is alpha-1 antitrypsin deficient

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 Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC

Summary: The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of patients with advanced non-small cell lung cancer.

Detailed description: Preliminary signals of clinical activity of ganetespib as a single agent have been observed in patients with advanced NSCLC. A Phase 2b/3 Study (9090-08) was initiated to evaluate the safety and activity of ganetespib in combination with docetaxel vs. docetaxel alone in NSCLC. Study 9090-08 is ongoing. Results from an interim analysis show that the combination has been well tolerated and an encouraging improvement in efficacy, including overall survival (OS) has been observed.
  Update: An independent data monitoring committee (DMC) was established to review accumulating unblinded safety data, and efficacy data at two specified Interim Analyses. The DMC monitored the conduct of the trial (including the accrual/retention of patients) and reviewed the risks and benefits. The study was stopped after the first Interim Analysis due to futility.
  The efficacy portion of this report is based on a 05 October 2015 data cut after the number of protocol-defined death events (336) for the first interim analysis had been achieved. The safety portion is based on the final database locked on 23 December 2015.

Eligibility: Inclusion Criteria:
  -  Advanced Stage IIIB or IV non-small-cell lung cancer (NSCLC)
  -  Eastern Oncology Cooperative Group (ECOG) Performance Status 0 or 1
  -  Prior therapy defined as 1 prior systemic therapy for advanced disease
  -  Documented disease progression during or following most first line therapy for advanced disease
  -  Adequate hematologic, hepatic, renal function
  Exclusion Criteria:
  -  Epidermal growth factor receptor (EGFR) mutations
  -  Anaplastic lymphoma kinase (ALK) translocations
  -  Predominantly squamous, adenosquamous or unclear histologic type
  -  Active or untreated central nervous system (CNS) metastases
  -  Active malignancies other than NSCLC within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
  -  Serious cardiac illness or medical conditions
  -  Pregnant or lactating women
  -  Uncontrolled intercurrent illness

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

Clinical trial: Post Market Observational, Prospective, Multi-center Study

Summary: This registry is a post market observational, prospective, multi-center registry. It is designed to evaluate patient experience with the RePneu™ device for the relief of the emphysema symptoms and the continued collection of safety and effectiveness data on this CE Mark product. In addition, the registry will collect information that will serve as the foundation for a cost effectiveness analysis.


Eligibility: Inclusion Criteria:
  -  All adult patients diagnosed with homogeneous or heterogeneous emphysema who are appropriate for Coil treatment based on the CE-Mark Approved IFU and who have been scheduled for treatment with the RePneu procedure
  -  RV of >175% predicted
  -  Post bronchodilator FEV1 of ≤45% predicted.
  -  Normal international normalized ratio (INR) in the absence of anticoagulation therapy
  -  Participant read, understood and signed the Informed Consent form
  Exclusion Criteria:
  -  Known uncontrolled pulmonary hypertension defined by systolic RVP >50mmHg
  -  Giant bullae > 1/3 lung volume
  -  Patients on antithrombotic treatment (except for aspirin) which cannot be stopped 7 days prior to treatment

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

Clinical trial: Lung Volume Reduction Coil Treatment in Emphysema.

Summary: -  BACKGROUND: Medical therapeutic options for the treatment of emphysema remain limited. Lung volume reduction surgery is infrequently used because of its high morbi-mortality. Endobronchial lung volume reduction coil (LVRC(®), PneumRx, Mountain View, CA) treatment has been recently developed and has been shown to be feasible and associated with an acceptable safety profile, while resulting in improvements in dyspnea, exercise capacity and lung function. The objective of this study is to analyze the cost effectiveness of LVRC treatment in severe emphysema.
  -  METHODS:This prospective, multicenter study, randomized with a 1:1 ratio (LVRC vs conventional treatment) will include 100 patients who will be followed up for 1year. The primary outcome measure is the 6-month improvement of the 6-minute walk test: the percentage of patients showing an improvement of at least 54m will be compared between groups. A cost-effectiveness study will estimate the cost of LVRC treatment, the global cost of this therapeutic option and will compare the cost between patients treated by LVRC and by medical treatment alone.
  -  EXPECTED RESULTS:This study should allow validating the clinical efficacy of LVRC in severe emphysema. The cost-effectiveness study will assess the medical-economic impact of the LVRC therapeutic option.


Eligibility: Inclusion Criteria:
  -  Bilateral emphysema on Chest CT Scanner
  -  Post bronchodilator FEV1 < 50 %
  -  Total Lung Capacity > 100 %
  -  Residual Volume > 220 %
  -  Dyspnea score between 2 and 4 based on the mMRC scale
  -  Stopped cigarette smoking for more than 8 weeks
  -  Pulmonary rehabilitation within the previous twelve months
  -  Consent form signed
  -  Covered by Medical Insurance
  Exclusion Criteria:
  -  Post bronchodilator FEV1 < 15%
  -  Post-bronchodilator change in FEV1 > 20%
  -  Severe recurrent respiratory infections requiring more than 2 hospitalization stays within the past twelve months
  -  COPD exacerbation requiring hospital stay within 3 months
  -  Pulmonary Hypertension (Pulmonary systolic pressure >50 mmHg on cardiac echo)
  -  Patient unable to perform a 6-min walking test in room air
  -  Giant bulla of more than 1/3 of the lung field on Chest CT
  -  Strictly homogeneous emphysema on Chest CT
  -  Clinically significant bronchiectasis
  -  Past history of lobectomy, lung volume reduction surgery, lung transplantation
  -  Any extrapulmonary diseases compromising survival or evaluation within the protocol (severe cardiac disease, severe renal insufficiency, cancer…)
  -  Lung carcinoma or pulmonary nodule on CT scan requiring Chest CT scan follow-up
  -  Contra-indication to general anesthesia
  -  Oral anticoagulant treatment (antivitamin K)
  -  Allergy to nitinol
  -  Inclusion in an other study assessing respiratory treatments
  -  Patient protected by the law

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

Clinical trial: Signet Ring Cell Carcinoma in Esophageal Adenocarcinoma

Summary: There has been much controversy surrounding the biologic behavior and prognosis of esophageal signet ring cell (SRCs) containing carcinomas. To clarify the biologic behavior of SRCs, the investigators compared the clinicopathologic features and prognosis of SRCs with other adenocarcinomas (ADC) of the esophagus and gastroesophageal junction (GEJ).

Detailed description: Adenocarcinoma (ADC) of the esophagus and gastroesophageal junction (GEJ) is an aggressive neoplasm and has a poor prognosis. Surgical based treatment has been the treatment of choice for localized esophageal adenocarcinoma.
  Signet-ring cell carcinoma is a unique histologic subtype of adenocarcinoma characterized by abundant intracellular mucin accumulation and a compressed nucleus displaced toward one extremity of the cell (the so-called signet-ring cell (SRC)). According to the World Health Organisation (WHO), a true signet-ring cell carcinoma (SRCca) is defined as an adenocarcinoma in which the predominant component (more than 50% of the tumor) consists of isolated or small groups of SRC in the stroma. If the tumor contains less than 50% of those cells, it is generally considered as an adenocarcinoma (ADC).

Eligibility: Inclusion Criteria:
  - Adenocarcinoma R0 resection Primary surgery
  Exclusion Criteria:
  - Other histology R1 or R2 resection Neoadjuvant therapy

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

Clinical trial: AVAdeno Study: An Observational Study of First-Line Avastin (Bevacizumab) in Patients With Adenocarcinoma of the Lung

Summary: This prospective observational study will evaluate the efficacy and safety of first-line Avastin (bevacizumab) in combination with platinum-based chemotherapy in different age groups (<60, 60-69, 70-79, >80 years) in patients with inoperable advanced, metastatic or recurrent adenocarcinoma non-small cell lung cancer. Patients will be followed for 18 months from the start of first-line therapy.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/= 18 years of age
  -  Histologically confirmed inoperable advanced, metastatic or recurrent pre-dominantly non-squamous adenocarcinoma non-small cell lung cancer
  Exclusion Criteria:
  -  Contraindications to Avastin treatment according to the Summary of Product 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: LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib

Summary: The primary purpose of the study is to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib.


Eligibility: Inclusion Criteria:
  1. Patient has a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive as assessed by the FDA approved Abbott FISH Test.
  2. Patient has stage IIIB or IV diagnosis and must have received one or two prior regimens (including platinum- doublet) of cytotoxic chemotherapy for the treatment of locally advanced or metastatic NSCLC.
  3. Patient has at least one measurable lesion as defined by RECIST 1.1. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation
  Exclusion Criteria:
  1. Patient with known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
  2. Patient with a history of severe hypersensitivity reaction to pemetrexed or docetaxel or any known excipients of these drugs.
  3. Patient with symptomatic central nervous system (CNS) metastases who is neurologically unstable or has required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms.

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

Clinical trial: EUS-guided Intratumoral Gemcitabine in Locally Advanced Unresectable Pancreatic Cancer

Summary: Pancreatic cancer is the 11th most common type of cancer but it is the fourth leading cause of cancer death. The only effective treatment for pancreatic cancer includes surgery. However, only 20% of the patients have surgically treatable disease. Also, the 5-year survival for the surgically treated patients is only 15%.
  About 40% of the patients present with advanced disease with distant metastasis, and the remaining 40% present with locally advanced unresectable cancer with the tumor invaded into surrounding major vessels. For those with locally advanced disease, systemic chemotherapy with or without radiotherapy provides palliation of the symptoms but cannot cure the disorder. Systemic chemotherapy is given through peripheral vessels.
  The investigators hypothesized that direct injection of the chemotherapeutic drug into the tumor may help to boost the effect of systemic chemotherapy and radiotherapy in those with locally advanced pancreatic cancer.

Detailed description: In this study, gemcitabine will be injected directly into the tumor by means of endoscopic ultrasound (EUS) in the eligible patients.

Eligibility: Inclusion Criteria:
  -  Patients with histologically verified pancreatic adenocarcinoma who have locally advanced unresectable tumor
  Exclusion Criteria:
  -  Early stage resectable pancreatic cancer with the intact surrounding major vessels on imaging
  -  Pancreatic cancer with distant metastasis
  -  Unwilling to sign informed consent

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 Observational Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer (ELEMENT)

Summary: This multicenter, observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic adenocarcinoma non-small cell lung cancer and an ECOG performance status of 0-1. Eligible patients receiving Tarceva according to the Summary of Product Characteristics and local label will be followed for the duration of their treatment.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/= 18 years of age
  -  Histologically or cytologically confirmed, locally advanced (Stage IIIb) or metastatic (Stage IV) adenocarcinoma non-small cell lung cancer
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  -  Adequate hematologic, renal and liver function
  -  Patient initiating treatment with Tarceva according to the Summary of Product Characteristics
  Exclusion Criteria:
  -  Any contraindications to treatment with Tarceva according to the Summary of Product Characteristics and local label
  -  Any other malignancies within the previous 5 years, except for in situ carcinoma of the cervix and basal and squamous cell carcinoma of the skin
  -  Previous systemic anti-cancer treatment with HER1/EGFR inhibitor

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 Phase I Study of iPS Cell Generation From Patients With COPD

Summary: As part of the long-term goal of successfully implementing tissue regeneration strategies in an individualized manner for patients with thoracic diseases including, but not limited to: cystic fibrosis, pulmonary fibrosis and pulmonary hypertension, the investigators will assess the feasibility of collecting skin biopsies from patients undergoing surgery for thoracic disease, culturing skin fibroblasts from the biopsy, and reprogramming these skin fibroblasts into induced pluripotent cells.


Eligibility: Inclusion Criteria:
  -  Undergoing Thoracic Surgery at the Mayo Clinic Rochester
  -  Presence of a Thoracic 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: Afatinib Plus Nimotuzumb for NSCLC

Summary: To find the optimal dose of afatinib and nimotuzumab in patients who acquired resistance to gefitinib or erlotinib.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed diagnosis of stage IIIB or IV NSCLC
  -  Presence of EGFR sensitizing mutations (L858R mutation in exon 21 or exon 19 deletion) or response by RECIST on prior gefitinib or erlotinib or stable disease on prior gefitinib or erlotinib for at least 6 months
  -  Disease progression on treatemtn with gefitinib or erlotinib within 30 days
  -  Biopsy on disease progression
  -  Age ≥20 years
  -  ECOG performance status of 0, 1, or 2
  -  Measurable disease by the criteria of RECIST 1.1
  -  Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance ≥ 45 mL/min
  Exclusion Criteria:
  -  Known interstitial lung disease
  -  Prior treatment with EGFR targeting antibodies or BIBW 2992
  -  Prior three or more lines of chemotherapy for advanced NSCLC
  -  Significant bowel disease impairing drug absorption
  -  Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
  -  Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases. Patients with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and corticosteroid use has been discontinued for at least 2 weeks prior to the first dose of study drug. Screening of asymptomatic patients without history of CNS metastases is not required.

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 CH5424802/RO5424802 in Patients With ALK-Rearranged Non-Small Cell Lung Cancer

Summary: This non-randomized, open-label, multicenter study will evaluate the safety and efficacy of CH5424802/RO5424802 in patients with ALK-rearranged non-small cell lung cancer who failed crizotinib treatment. In Phase I, cohorts of patients will receive escalating doses of CH5424802/RO5424802 orally twice daily. In Phase II, patients who failed crizotinib treatment will receive the recommended phase II dose (600 mg) daily in two oral doses.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/= 18 years of age
  -  Histologically confirmed, locally advanced, not amenable to curative therapy, or metastatic non-small cell lung cancer (NSCLC)
  -  ALK-rearrangement confirmed by FDA approved test
  -  NSCLC that has failed crizotinib treatment
  -  Measurable disease as defined by RECIST v1.1
  -  Eastern Cooperative Oncology Group (ECOG) performance status </= 2
  -  Adequate hematologic, hepatic and renal function
  Exclusion Criteria:
  -  Prior therapy with ALK inhibitor other than crizotinib
  -  Brain or leptomeningeal metastases that are symptomatic and/or requiring treatment
  -  History of serious cardiac dysfunction
  -  History of or current active infection with hepatitis B, hepatitis C or HIV
  -  Clinically significant gastrointestinal abnormality that would affect absorption of the drug
  -  Pregnant or lactating women

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

Clinical trial: Analysis of Plasma Tumor DNA in Lung Cancer Patients

Summary: The presence of genetic alterations in the tyrosine kinase domain of the oncogene (eg. EGFR and ALK) is associated with the clinical response to tyrosine kinase inhibitors (TKIs) in patients with non-small cell lung cancers. Therefore, the detection of altered genetic alterations is useful for predicting the treatment response for TKIs in non-small cell lung cancer patients. However, good quality tumor tissues are available only in <50% of patients with inoperable lung cancer for mutation analysis. In this study, the investigators will detect and quantify the genetic alterations in plasma. the investigators will investigate if the serial measurement of cancer-derived genetic alterations in plasma can provide a means for monitoring disease progression, as well as treatment response. In addition the investigators will analysis the resistant mechanism of TKIs and chemotherapy with plasma tumor DNA.


Eligibility: Inclusion Criteria:
  -  Have a histologically or cytologically confirmed diagnosis of non-small cell lung cancer
  -  Have molecular evidence of genetic alterations in tumor sample (eg. EGFR mutations, ALK fusions)
  -  Patients must have given written informed consent
  Exclusion Criteria:
  -  Patients who refuse the blood samplings

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 Open Label Study of BIBW 2992/Afatinib in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib

Summary: Advanced lung cancer (non-small cell lung cancer) with a mutation in the EGFR (epidermal growth factor receptor) gene, which have disease progression after treatment with an EGFR inhibitor (erlotinib or gefitinib), and have progression of disease also after treatment with chemotherapy will be recruited. The trial has only one arm, of afatinib daily treatment. Blood and exhaled breath samples will be collected for investigations aiming to identify factors that predict response to afatinib.


Eligibility: Inclusion Criteria:
  -  Advanced NSCLC
  -  EGFR mutation or six months or longer benefit from EGFR TKIs
  -  Disease progression on chemotherapy, or inability to receive chemotherapy for medical reasons.
  -  Disease progression on EGFR TKI, or the presence of an EGFR mutation that does predicts for poor response to first generation EGFR TKIs.
  Exclusion Criteria:
  -  Inability to take oral drugs

Relevance to patient case: not relevant