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: An Investigational Drug, Crizotinib (PF-02341066), Is Being Studied In Tumors, Except Non-Small Cell Lung Cancer, That Are Positive For Anaplastic Lymphoma Kinase (ALK)

Summary: This is a Phase 1 trial evaluating the safety and efficacy of crizotinib in patients with tumors except non-small cell lung cancer that are positive for ALK.


Eligibility: Inclusion Criteria:
  -  histologically or cytologically proven diagnosis of malignancy other than NSCLC
  -  positive for translocation or inversion event involving the ALK gene locus
  -  positive for ALK amplification events
  -  positive for ALK activating point mutations
  Exclusion Criteria:
  -  mutations of amplifications involving the c-Met gene but not the ALK gene
  -  concurrent treatment on another therapeutic clinical trial
  -  prior therapy specifically directed against ALK

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: Validation of a Multi-gene Test for Lung Cancer Risk

Summary: The purpose of this study is to determine the validity of a multi-gene Lung Cancer Risk Test (LCRT). In the process, the investigators will establish a bank of NBEC samples and corresponding blood samples from individuals demographically at increased risk for lung cancer.

Detailed description: Because more than 160,000 individuals die of lung cancer/year in the United States alone, it is important to use the best possible methods to determine whether increased surveillance of individuals at highest risk for lung cancer will result in reduced lung cancer mortality. The Lung Cancer Risk Test (LCRT) proposed for evaluation promises to accurately identify the 10-15% of the population that is most susceptible to lung cancer based on genetic predisposition. More than 90 million individuals in the United States alone are demographically at high risk for lung cancer and potential candidates for increased surveillance.

Eligibility: Inclusion Criteria:
  -  20 or more pack year smoking history
  -  clinical need for diagnostic bronchoscopy or consent to study driven bronchoscopy
  Exclusion Criteria:
  -  Lung Cancer within 3 months after the date of enrollment

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: Hydros Joint Therapy and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis (OA)

Summary: The purpose of this study is to evaluate the safety and performance of Hydros Joint Therapy (Hydros) and Hydros-TA Joint Therapy (Hydros-TA) for treatment of pain from osteoarthritis of the knee, in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.

Detailed description: The objective of the study is to evaluate Hydros and Hydros-TA treated subject for reduction of osteoarthritis symptoms, compared to a commercial control, as assessed by the WOMAC Osteoarthritis Index.
  The WOMAC Osteoarthritis Index is a validated assessment instrument that is self-administered and designed to subjectively elicit patient symptoms of osteoarthritis in the knee in the areas of pain, stiffness, and physical function. The WOMAC Osteoarthritis Index with its Pain Subscale has been used extensively as an effectiveness endpoint in clinical trials of viscosupplements.

Eligibility: Inclusion Criteria:
  - Osteoarthritis grade 2 or 3 in one knee using Kellgren-Lawrence Grading for OA radiologically and verified within the prior 6 months.
  Exclusion Criteria:
  -  Secondary OA resulting from rheumatoid arthritis, chondrocalcinosis, osteonecrosis, chronic fibromyalgia or other autoimmune disease.
  -  Generalized symptomatic OA in lower extremity joints other than the knees.
  -  Active infection in either knee joint or adjacent tissues.
  -  Any contraindications for intra-articular injection or aspiration.
  -  Knee surgery or trauma within 3 months prior to enrollment.
  -  Intra-articular steroid injection in the knee and/or use of systemic (oral) corticosteroids within 3 months prior to enrollment.
  -  Intra-articular hyaluronan injection in the treatment knee within 6 months prior to enrollment.
  -  Body Mass Index (BMI) greater than 35.

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 Retrospective Pharmacoeconomic Study of Lung Cancer

Summary: Lung cancer is the No. cause of cancer death in Taiwan. Yet most of lung cancer are diagnosed at late stage, not amenable to surgical resection. With the introduction of new targeted agents, such as EGFR tyrosine kinase inhibitors and the identification of EGFR mutations, lung cancer management has markedly changed in recent years. However, these new agents are costly and their payment is restricted in certain situations defined National Insurance Agency. Therefore, using databases from National Insurance Agency might not be able to reflect the exact impact on pharmacoeconomics. In this study, the investigators will analyze the data from a tertiary medical center, where all the costs including insurance reimbursement, co-payment, and payment not covered by insurance. The investigators will also compare with the investigators results with national database to analyze the cost benefit of these new agents on lung cancer.


Eligibility: Inclusion Criteria:
  -  lung cancer patients in WanFang Hospital
  Exclusion Criteria:
  -  non

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: Non Small Cell Lung Cancer Evaluation According to Pre-determined Drug-targeting Tumor Markers

Summary: Evaluate chemotherapy related tumor markers on non small cell lung cancer by fluorescent in situ hybridization and immunohistochemistry, targets to be studied include EGFR, c-MET, topoisomerase II, p53, topoisomerase I, thymidylate synthase, ERCC1, tau, c-myc, RRM1, class III tubulin. These targets have been chosen because they are targets for chemotherapeutic agents that are currently used in clinical management of these diseases. In total 50 specimen will be studied, approximately one third have mutations/deletions of the EGFR gene.To attempt to establish a correlation between the pre-selected tumor markers and response to chemotherapy, and thus to be able to create a clinically useful classification that would provide clinical guidance for selection of the most effective chemotherapy for a individual patient, and thus be able to logically design more effective clinical trials for the future.


Eligibility: Inclusion Criteria:
  -  Patients with histologically confirmed lung cancer who received standard platinum-containing doublet chemotherapy followed by EGFR tyrosine kinase inhibitors.
  Exclusion Criteria:
  -  non

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: Early Detection of Lung Tumors by Sniffer Dogs - Evaluation of Sensitivity and Specificity

Summary: Some groups reported that sniffer dogs can be applied to detect lung cancer in the exhaled breath of patients. Therefore, breath samples (BS) of patients are collected. Five sniffer dogs are trained to distinguish between the BS of patients with lung cancer and healthy individuals (controls). In a prospective, randomized blinded study the dog's ability to differentiate between BS of i) patients with lung cancer, ii) patients with inflammatory airway disease, but no evidence of cancer and iii) healthy individuals is tested.

Detailed description: All breath samples (BS) are collected in patients on the basis of radiologic findings before any intervention (bronchoscopy, biopsy or surgery) has been performed. The allocation to study groups is made following diagnostic work up and surgery.
  Three study groups are defined using the following inclusion and exclusion criteria:
  -  lung cancer: male & female, age 18-80, competent, confirmed lung cancer in diagnostic work up and surgery, no history or present other tumor disease
  -  healthy individual: male & female, age 18-80, competent, no history or present other tumor disease including lung cancer, no pathological lung function tests
  -  chronic obstructive lung disease: male & female, age 18-80, competent, no history or present other tumor disease including lung cancer, pathological lung function tests
  For each patient, i) history, ii) present medication, iii) lung function tests are documented. For the lung cancer patients, the tumor stage following surgery is documented.
  Five sniffer dogs are trained using BS of lung cancer patients and healthy individuals. After completion of the training the ability of the dogs to differentiate between the groups is tested:
  -  5 BS are presented in 1 experiment:
  -  Test I: lung cancer vs healthy individual
  -  Test II: lung cancer vs chronic obstructive pulmonary disease
  -  Test III: lung cancer vs healthy individuals & bronchitis
  -  for every experiment 1 BS of a lung cancer patient is used
  -  the lung cancer sample is placed randomly in one of the five test tubes
  -  the other test tubes are used for BS of healthy individuals or chronic obstructive pulmonary disease patients or both
  -  neither the dog handler nor the dog know the loading of the test tubes
  -  experiments are repeated 5 to 10 times
  For analysis, the sensitivity and specificity of the dog's reaction is determined.
  The patient's medication, smoking habits, age and gender are analysed to rule out confounders or bias.

Eligibility: Inclusion Criteria:
  -  age 18-80
  -  competent
  -  confirmed lung cancer
  Exclusion Criteria:
  -  history of other cancers

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 Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung

Summary: This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.


Eligibility: Inclusion Criteria:
  -  Proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung
  -  Positive for translocation or inversion events involving the ALK gene locus
  -  No prior systemic treatment for locally advanced or metastatic disease; Patients with brain metastases only if treated and neurologically stable with no ongoing requirement for corticosteroids
  -  Evidence of a personally signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures including completion of patient reported outcome [PRO] measures.
  -  18 years of age or older with the exception of India which has an upper age limit of 65 years old
  Exclusion Criteria:
  -  Current treatment on another therapeutic clinical trial.
  -  Prior therapy directly targeting ALK.
  -  Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. - - Appropriate treatment with anticoagulants is permitted.
  -  Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation of any grade, or QTc interval >470 msec.
  -  Pregnancy or breastfeeding.
  -  Use of drugs or foods that are known potent CYP3A4 inducers/inhibitors Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.
  -  Known HIV infection
  -  Known interstitial lung disease or interstitial fibrosis
  -  Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study

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

Clinical trial: Studies Examining the Importance of Smoking After Being Diagnosed With Lung Cancer

Summary: A large project consisting of:
  a) an observational trial where smoking status is recorded on 1400 consecutive people newly diagnosed with lung cancer. Smoking status is biologically validated with exhaled carbon monoxide (eCO) levels every 3 months. Survival, cancer progression and treatment complications will be recorded and compared in smokers, ex-smokers and never smokers.

Detailed description: Smoking causes around 85% of lung cancer. Continued smoking after diagnosis probably worsens survival and increases treatment complications but prospective well-designed studies are lacking.
  This project is an observational cohort study recording outcomes in smokers, never-smokers, and ex-smokers, using exhaled carbon monoxide to validate smoking status when they attend for further lung cancer clinics.
  This project is unique, as every patient with a clinical diagnosis of lung cancer will have their smoking status biologically validated by a quick and easy test, and those enrolled in the smoking cessation treatments or not will also complete a generic quality of life questionnaire at regular intervals. These appointments will coincide with other hospital appointments wherever possible, and survival status will reported up to 24 months after enrolment.

Eligibility: Inclusion Criteria:
  -  clinical diagnosis of lung cancer
  Exclusion Criteria:
  -  refusal Consent
  -  inability to provide exhaled CO
  -  active psychiatric illness or substance misuse
  -  concurrent malignancies of another type other than non-melanoma skin cancer
  -  unable to travel for sessions with smoking cessation counsellor and / or outpatient visits from outset
  -  WHO performance status 4
  -  Life expectancy less than 6 weeks.

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: Chest Computed Tomography (CT) Screening Study With Antibody Testing

Summary: The purpose of this study is to assess the value of EarlyCDT-Lung test and CT scan both in lung cancer detection and potential health economic outcomes.

Detailed description: EarlyCDT-Lung test and CT scan both for lung cancer detection and potential economic outcomes.

Eligibility: -  Persons 50-75
  -  Asymptomatic for lung cancer
  -  Current or former (stopped smoking less than 10 years ago) cigarette smokers
  -  History of cigarette smoking of at least 20 pack years
  -  History of cigarette smoking with a family history of lung cancer which gives an individual a personal risk similar to a smoking history of 20 pk/years (i.e. 1% at 5 years).
  -  Mentally competent individuals to sign an informed consent.
  -  Healthy enough to undergo pulmonary resection or stereotactic body radiotherapy.
  -  A fully informed signed consent form must have been obtained.

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 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: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

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: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

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: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: The Effect of Zoledronic Acid to Bone Fusion and Bone Metabolism of Patients With Lumbar Degenerative Disease After Lumbar Interbody Fusion

Summary: Many patients who have lumbar degenerative disease suffer from osteoporosis or reduced bone mass or low bone mineral density. Among patients with lumbar degenerative disease, some need fusion surgery. But conditions of osteoporosis or low bone mineral density slow down the rate of bone fusion, reduce the success of bone fusion, and ultimately affect the overall effectiveness of surgery. Zoledronic acid is an effective anti-osteoporotic. Many researchers dispute if zoledronic acid can promote the healing of long bone fractures. But few researchers focus on the effect of zoledronic acid to lumbar fusion. In this study, we select patients with lumbar degenerative disease who have had lumbar interbody fusion surgery. Three days postoperatively, the patients were randomized to either one infusion of zoledronic acid or sodium chloride intravenously. We follow all these patients for 6 months. During this time, we detect bone metabolism and bone fusion of these patients. At last, we can tell if zoledronic acid can modify bone metabolism and promote bone fusion.


Eligibility: Inclusion Criteria:
  -  Patients with lumbar degenerative disease who have had lumbar interbody fusion surgery
  -  Age 50-70 years old
  -  Willing to sign informed consent
  Exclusion Criteria:
  -  Application of strontium ranelate, sodium fluoride or parathyroid hormone
  -  Application of bisphosphonates more than 8 weeks during 2 years preoperatively
  -  Suffering from bone fracture during 3 months preoperatively
  -  Urinary creatinine clearance rate less than 35mL/min
  -  Serum calcium concentrations greater than 2.75mmol/L or less than 2.00mmol/L
  -  Pregnancy or breast-feeding women
  -  Suffering from cancer or other diseases that may be expected to live less than a year

Relevance to patient case: not relevant