araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: Study on Allogeneic Osteoblastic Cells Implantation in Rescue Interbody Fusion

Summary: Failed fusion and failure to relieve back pain following spinal fusion are still frequent, irrespective of the type of procedures or grafts used by the surgeon. Moreover, revision surgeries are unfortunately associated with higher procedure-related complication rates, technical difficulties, longer operative time, and quite disappointing and unreliable success rates for both fusion and clinical results.
  The present Phase 2a study aims at demonstrating the safety and efficacy of ALLOB®, a proprietary population of allogeneic osteoblastic cells, in rescue interbody fusion.


Eligibility: Inclusion Criteria:
  -  Ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements
  -  Failed lumbar fusion of 15 months minimum requiring a revision surgery at one or two levels between L1 and S1
  Exclusion Criteria:
  -  More than two failed interbody fusions at the involved lumbar level(s)
  -  Instrumentation failure requiring revision surgery
  -  Local active or latent infection at the involved lumbar level(s)
  -  Positive serology for hepatitis B, hepatitis C, HIV
  -  Current or past medical disease that could interfere with the evaluation of the safety and efficacy, as judged by the investigator

Relevance to patient case: not relevant
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: Could the Stroke Volume Variation Predict a Fluid Responsiveness in Thoracotomy?

Summary: There are some risks of pulmonary edema in patients undergoing pulmonary lobectomy with one lung ventilation. The overloading of fluid administration could be related to the development of pulmonary edema in patents after thoracic surgery. But fluid restriction may cause major organ hypoperfusion during the surgery. The purpose of this study is to evaluate the ability of stroke volume variation as an indicator for a fluid responsiveness in patient who receives pulmonary lobectomy via thoracotomy.

Detailed description: Perioperative fluid management during thoracic surgery is a significantly important, because it is quite difficult to prevent pulmonary edema due to the fluid overload and compromise perfusion of vital organ. So, it is essential to maintain optimal organ perfusion by appropriate fluid management during thoracic surgery. Stroke volume variation (SVV) is derived from pulse contour analysis and it is known that SVV ≥12~15% correlate with fluid responsiveness, defined as a significant increase in cardiac output with fluid loading, dung two-lung ventilation. It is a parameter derived from changes in stroke volume (SV) that is according to the heart-lung interaction during mechanical ventilation. positive pressure ventilation induces cyclic changes in left ventricular SV that are related mainly to the expiratory decrease in right ventricular filling and ejection. This is a reflected by variations in the SV. However both ventilator issues, such as tidal volume, PEEP, chest and lung condition, and the cardiovascular condition, such as heart rate, rhythm, ventricular function, cardiac afterload, arterial compliance may affect SVV. Recently some studies reported that SVV could predict fluid responsiveness in mechanically ventilated patients under various conditions. But it is still unclear whether SVV could predict fluid responsiveness during one lung ventilation with the chest open via a thoracotomy. During one-lung ventilation, the shunted blood flow through the non-ventilated-lung dose not contribute to the generation of SVV. And with the chest opening by thoracotomy, the pressure generated by ventilator would not be transmitted to the pulmonary vessels but rather to the atmosphere. So, the purpose of this study is to evaluate the ability of SVV as an indicator a fluid responsiveness particularly in patients undergoing one-lung ventilation with thoracotomy and to found the optimal threshold value of SVV for fluid management during thoracic surgery.

Eligibility: Inclusion Criteria:
  -  The patients scheduled for pulmonary lobectomy with one lung ventilation by lung cancer, nodule, or pulmonary tuberculosis under thoracoscopy or thoracotomy in our hospital
  Exclusion Criteria:
  -  The patients with known cardiac disease include arrythmia
  -  American society of anesthesia physical status III, IV, V

Relevance to patient case: not relevant
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC

Summary: This is a multinational, double-blind, randomized, parallel-group Phase 3 clinical trial evaluating the efficacy and safety of bevacizumab-Pfizer plus paclitaxel and carboplatin versus bevacizumab-EU plus paclitaxel and carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.


Eligibility: Inclusion Criteria:
  -  Male and female patients age at least 18 years of age, or age of consent in the region.
  -  Newly diagnosed Stage IIIB or IV non-small cell lung cancer (according to Revised International System for Staging Lung Cancer criteria of 2010) or recurrent non-small cell lung cancer (NSCLC).
  -  Histologically or cytologically confirmed diagnosis of predominately non-squamous NSCLC.
  -  Be eligible to receive study treatment of bevacizumab, paclitaxel, and carboplatin based on local standard of care, for the treatment of advanced or metastatic non-squamous NSCLC.
  Exclusion Criteria:
  -  Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature.
  -  Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that is likely to bleed.
  -  Known sensitizing EGFR mutations (for example, deletion 19 or L858R) or EML4-ALK translocation positive mutations.
  -  Prior systemic therapy for NSCLC; prior neoadjuvant or adjuvant therapy is allowed if surgical resection for primary disease was performed.

Relevance to patient case: not relevant
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: Characterization of Methylation Patterns in Lung Cancer

Summary: In this study the investigators will collect Blood,sputum and saliva samples for Characterization of Methylation Patterns in lung Cancer.

Detailed description: Lots of information about the relationship between changes in methylation patterns and various diseases are accumulated in recent years. Characterization of methylation changes that occur in cancer may contribute to the development of methods for early detection of cancer by detecting cancer cells in liquids. Early detection of such changes and their correlation examining different cancers may lead to a diagnostic tool for the early detection of cancers and improve the treatment of these patients. Detection by molecular analysis can be a sensitive method and non-invasive early diagnosis of the disease In this study the investigators will collect Blood,sputum and saliva samples for Characterization of Methylation Patterns in lung Cancer.

Eligibility: Inclusion Criteria:
  -  Patients with suspected lung tumor
  Exclusion Criteria:
  -  Patients who have active disease other than lung cancer during the sample collecting

Relevance to patient case: not relevant
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: Individualized Treatment of Patients With Advanced NSCLC: Potential Application for Circulating Tumor Cells (CTC) Molecular and Phenotypical Profiling

Summary: The purpose of this study is to determine the percentage of CTC-positive patients and total CTC numbers in patients with advanced Non Small Cell Lung Cancer .

Detailed description: The primary aim of the Project is to determine the percentage of CTC-positive patients and total CTC numbers in advanced NSCLC at baseline, before starting treatment.
  To valuate CTC count modifications as an early predictor of response to treatment a prospective observational study will be conducted, consecutively enrolling 150 patients regardless of type or line of therapy, which will be reevaluated for disease status and CTC count depending on the type and schedule of treatment.
  Furthermore, purified CTC will be obtained by automated platform and DNA sequencing will be performed to assess sensitizing mutations in advanced NSCLC patients. The EGFR mutations or EML4-ALK fusion gene detected in CTC will be compared with those reported for the tumor specimen using standard sequencing.
  In parallel, the CTC count assay will be integrated with mAb targeting EGFR or EML4-ALK fusion gene, to test whether assaying the quote of EGFR-positive and ALK-positive CTC provides a more sensitive marker for rating pharmacodynamic effects in patients compared with total CTC counts.
  Moreover, it was reported that NSCLC cells with EGFR mutations manifest activation of the PI3K (phosphatidylinositol 3-kinase)-AKT and MEK-ERK (extracellular signal-regulated kinase) signaling pathways under the control of EGFR, and exposure of such cells to EGFR-TKIs blocks signaling by both pathways and induces apoptosis 13. To evaluate whether live vs. apoptotic CTC changes under treatment may be used as predictor of tumor response, M30-positive CTC will be quantified as previously 8.
  Data obtained with the CTC assay will be correlated with common prognostic factors.

Eligibility: Inclusion Criteria:
  -  Age 18-80 years old, males or females;
  -  Patients with NSCLC confirmed by histopathology or cytology;
  -  Life expectancy > 6 months;
  -  Patients are voluntary to participate and sign the informed contents
  Exclusion Criteria:
  -  Any condition which might hamper compliance to the schedule of assessments

Relevance to patient case: not relevant
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: Mutation Detection of EBUS-TBNA Specimens Using NGS

Summary: The objective of the study was to compare the value of routine gene testing and next-generation sequencing (NGS) in detecting gene mutations of small specimens obtained by endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) and get the knowledge of how many EBUS-TBNA samples were adequate for NGS.

Detailed description: Some gene mutations can direct individualized treatment. The routine gene testing of EGFR, ROS1 and ALK is direct sequencing, Reverse transcription quantitative real-time polymerase chain reaction (RT-QPCR) and fluorescent in situ hybridization (FISH) or immunohistochemistry (IHC). Next-generation sequencing (NGS) is a new technique, which is more sensitive than routine techniques. So we decided to compare the value of gene testing between routine method and NGS in EBUS-TBNA specimens and get the knowledge of how many EBUS-TBNA samples were adequate for NGS.
  The study was designed as a prospective and single center study. Seventy patients will be enrolled into the study and the clinical data of the patients, including his smoke history, cancer history, occupation exposure and so on, will be collected and recorded in a case report form. For the patients recruited in the study, the lymph nodes suspected to be malignant will be obtained by EBUS-TBNA. Samples will be sent to Pathology Department of Shanghai Chest Hospital and will be processed with paraffin-embedded, and for those diagnosed with nonsquamous NSCLC, routine gene testing of EGFR, ROS1 and ALK will be performed. And the rest tissues will be extracted with DNA and performed gene mutations using NGS for these qualified DNA samples.

Eligibility: Inclusion Criteria:
  1. Patients who are suspected with nonsquamous non-small cell lung cancer according to the clinical, lab examination and imaging data and had never been diagnosed as primary lung cancer before will be enrolled into the study.
  2. The clinical stage of the patients should be in stage IIIA-IV judged by the imaging data and can't receive surgery initially.
  4. There exist at least one lesions that can be obtained by EBUS-TBNA.
  Exclusion Criteria:
  1. The patient is highly suspected to benign lesion, small cell lung cancer and squamous cell carcinoma according to the clinical data.
  2. Surgery was considered to be the primary treatment.
  3. Patients who are diagnosed with lung cancer and received treatment with drugs or recurrent with lung cancer will be excluded.
  4. Severe cardiopulmonary dysfunction and other indications that can't tolerate bronchoscopy.

Relevance to patient case: not relevant
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: Clinical Observation and MRI Influence of Acupuncture on Knee Osteoarthritis

Summary: To observe the therapeutic effect of acupuncture on osteoarthritis(OA) and its efficacy on cartilage restoration,acupuncture and physiotherapy treatment were respectively given to two random groups. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to evaluate the motor function of knee joints, followed by magnetic resonance imaging (MRI) scanning to measure T2 values in ten cartilage sub-regions in tibiofemoral joints.

Detailed description: To observe the therapeutic effect of acupuncture on osteoarthritis and its efficacy on cartilage restoration,one hundred knees of 50 patients with knee osteoarthritis were randomly divided into acupuncture group and physiotherapy group which were respectively received acupuncture and physiotherapy treatment for four weeks. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to evaluate the motor function of knee joints, followed by magnetic resonance imaging (MRI) scanning to measure T2 values in ten cartilage sub-regions in tibiofemoral joints.

Eligibility: Inclusion Criteria:
  -  Clinically diagnosed as knee osteoarthritis according to the OA criteria proposed by American College of Rheumatology in 1995.
  Exclusion Criteria:
  -  Acute knee injury
  -  Had ever accepted therapy as hormone or injection in articulation cavity
  -  Had ever accepted treatment as oral medicine, physiotherapy, acupuncture or massage during the passed three months
  -  Had planted cardiac pacemaker or any metal matter in body
  -  Other severe diseases such as heart, lung, liver, kidney or cerebrum failure, tumors, gastrointestinal hemorrhage and so on
  -  Pregnant or lactating woman
  -  Anyone unable to tolerate or cooperate with treatment.

Relevance to patient case: not relevant
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: LDK378 in Patients With ALK Positive NSCLC Previously Treated With Alectinib.

Summary: This is a single-arm, open-label, multicenter, phase II study to evaluate the efficacy and safety of the ALK inhibitor LDK378 when used as single agent in patients with ALK-rearranged stage IIIB or IV NSCLC previously treated with alectinib. Treatment with LDK378 750 mg qd will continue until the patient experiences disease progression as determined by the investigator according to RECIST 1.1, unacceptable toxicity that precludes further treatment, pregnancy, start of a new anticancer therapy, discontinues treatment at the discretion of the patient or investigator, lost to follow-up, death, or study is terminated by Sponsor.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of Stage IIIb or IV NSCLC that carries an ALK rearrangement as determined locally by Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test.
  -  Patients must have NSCLC that has progressed at study enrollment.
  -  Patients must have received previous treatment with alectinib for treatment of locally advanced or metastatic NSCLC. Prior therapy with crizotinib as ALK inhibitor therapy in addition to alectinib is allowed. Alectinib doesn't need to be the last therapy prior to study enrollment. No particular sequence of prior alectinib and crizotinib is required for enrollment.
  -  Patients must be chemotherapy-naïve or have received only one line of prior cytotoxic chemotherapy.
  -  Age 18 years or older at the time of informed consent.
  Exclusion Criteria:
  -  Patients with known hypersensitivity to any of the excipients of LDK378.
  -  Prior therapy with other ALK inhibitor investigational agents except crizotinib and alectinib.
  -  Prior systemic anti-cancer (including investigational) therapy aside from alectinib, crizotinib and one regimen of previous cytotoxic chemotherapy for locally advanced or metastatic NSCLC.
  -  Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
  -  Patient with history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis.
  -  Ptients with history of carcinomatous meningitis.
  -  Patient with a concurrent malignancy or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
  -  Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months)
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: definitely relevant
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: Ceritinib Rare Indications Study in ALK+ Tumors

Summary: This is Proof-of-Concept (POC) study to assess the preliminary antitumor activity and safety and tolerablity using ceritinib (LDK378) in the treatment of life threatening tumors that are characterized by ALK genetic alteration (and/or overexpression in some diseases).


Eligibility: Inclusion Criteria:
  -  Patient has a histologically or cytologically confirmed diagnosis of ALK positive (ALK+) other than Non-Small Cell Lung Cancer (NSCLC).
  -  Patient must provide an archival or fresh tumor tissue before the first dose of the study drug for ALK testing at a Novartis designated central laboratory.
  -  Patient has WHO Performance Status (PS) ≤ 2
  -  Patient must have received at least one line of prior systemic treatment for recurrent, locally advanced and/or metastatic disease, may have discontinued for:
  -  Disease progression as defined by RECIST 1.1 for solid tumors; by RANO for GBM and by Cheson assessment criteria for lymphoma
  -  Intolerance described as any discontinuation due to an AE of any grade despite appropriate supportive treatment
  -  Patient has at least one measurable lesion as defined by appropriate guidelines. A lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation.
  Exclusion Criteria:
  -  Patient has ALK+lung cancer
  -  Patient with symptomatic CNS metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
  -  Patient with acute or chronic GI disease that may significantly alter the absorption of ceritinib.
  -  Patient with a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
  -  Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis.
  -  Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months).
  -  Patient has evidence of active viral hepatitis, including Hepatitis A, B or C (testing for viral hepatitis is not mandatory).
  -  Patient has known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory).

Relevance to patient case: definitely relevant
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: Functional Status in Patients Undergoing Curative Treatment for Lung Cancer

Summary: This trial investigates the impact of curative lung cancer treatment on functional status and exercise tolerance. Furthermore this trial investigates possible underlying causes and consequences of deconditioning.

Detailed description: Preliminary evidence suggests that patients with lung cancer experience a decrease of exercise tolerance and muscle strength during the course of their treatment. The underlying mechanisms and impact of this change has not yet been investigated. In light of this, our trial will prospectively follow a convenience sample of 70 patients with lung cancer who are treated curatively. Patients will be assessed before, during and at the end of the treatment (surgery and/or chemotherapy and/or radiotherapy). The aims of the study are to
  1. Investigate the influence of curative treatment for lung cancer on functional and maximal exercise tolerance (primary outcome).
  2. Investigate the metabolic changes underlying changes in exercise tolerance during curative treatment for lung cancer (primary outcome).
  3. Investigate the relationship between changes in exercise tolerance, daily physical activity, pulmonary function and skeletal muscle function during curative treatment for lung cancer (secondary outcome).
  4. Investigate the relationship between changes in exercise tolerance and self-reported quality of life, functional status, feelings of anxiety and depression and symptoms during curative treatment for lung cancer (secondary outcome).
  5. Investigate the relationship between physical activity and exercise tolerance on one hand and comorbidities, hospitalisations and cancer-related and all-cause mortality on the other hand after curative treatment for lung cancer (exploratory outcome).

Eligibility: Inclusion Criteria:
  -  curative treatment for lung cancer
  Exclusion Criteria:
  -  presence of other neoplasms
  -  progressive neuromuscular and neurological diseases
  -  unstable cardiac disease
  -  pulmonary hypertension
  -  interstitial lung disease
  -  orthopedic conditions that significantly impair functional status
  -  mental or psychiatric disorders that impair the ability to comply with study procedures.
  -  a history of cerebrovascular accident with remaining functional consequences
  -  a history of lung cancer
  -  lack of knowledge of the Dutch, French or English language will be excluded

Relevance to patient case: not relevant