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: Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*24 Disease Controlled Advanced Non-small Cell Lung Cancer

Summary: The investigators previously identified three novel HLA-A*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, as targets for vaccination against lung cancer. In this clinical study, the investigators examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment to prevent relapse of the disease for HLA-A*2402-positive advanced non-small cell lung cancer patients whose disease are controlled after any standard therapies.

Detailed description: The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A*2402 restricted epitope peptides URLC10, CDCA1, and KIF20A emulsified with Montanide ISA 51 for disease controlled advanced non-small cell lung cancers.
  The investigators previously identified three novel HLA-A*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, as targets for cancer vaccination against lung cancer. In this phase I/II trial, the investigators examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A*2402-positive advanced non-small cell lung cancer patients whose disease are controlled after any standard therapies, but who do not have any options for additional standard ones to prevent .future relapse of the disease.

Eligibility: Inclusion Criteria:
  1. NSCLC whose disease are controlled after any standard therapies, but who do not have any additional standard ones to prevent .future relapse of the disease.
  2. ECOG performance status 0-2
  3. Age between 20 to 85
  4. Clinical efficacy can be evaluated by some methods
  5. No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within appropriate periods
  6. Life expectancy > 3 months
  7. Laboratory values as follows 1500/mm3 < WBC < 15000/mm3 Platelet count > 75000/mm3 Asparate transaminase < 3 X cutoff value Alanine transaminase < 3 X cutoff value Total bilirubin < 3 X cutoff value Serum creatinine < 2X cutoff value
  8. HLA-A*2402
  9. Able and willing to give valid written informed consent
  Exclusion Criteria:
  1. Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia)
  2. Myocardial infarction within six months before entry
  3. Breastfeeding and Pregnancy (woman of child bearing potential)
  4. Active and uncontrolled infectious disease
  5. Concurrent treatment with steroids or immunosuppressing agent
  6. Other malignancy requiring treatment
  7. Non-cured traumatic wound
  8. Decision of unsuitableness by principal investigator or physician-in-charge

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: Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer

Summary: This randomized phase 2 trial is studying the effect of adding denosumab to standard chemotherapy in the treatment of advanced lung cancer.

Detailed description: This is a global phase 2 randomized double-blind placebo-controlled study in subjects with Stage IV untreated NSCLC with or without bone metastasis. Eligible subjects are to receive 4 to 6 cycles of a standard of care platinum-doublet chemotherapy regimen. Approximately 216 subjects will be randomized in a 2:1 ratio to receive denosumab or matching placebo with the first investigational product dose coinciding with subject's first cycle of chemotherapy and continuing until the primary analysis, unacceptable toxicity, withdrawal of consent, death, or lost to follow-up. Subjects will be offered open label denosumab if study results show a positive benefit:risk profile, or be followed long-term, for up to 2 years. All subjects are to receive daily dietary supplements of at least 500 mg of calcium and 400 IU of vitamin D.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed stage IV non-small cell lung carcinoma (NSCLC), according to 7th TNM classification (cytological specimens obtained by bronchial washing or brushing, or fine-needle aspiration are acceptable)
  -  Subject has available and has provided consent to release to the sponsor (or designee) a tumor block with confirmed tumor content (or approximately 20 unstained charged slides [a minimum of 7 slides is mandatory]) and the corresponding pathology report
  -  Planned to receive 4 to 6 cycles of pemetrexed or gemcitabine in combination with cisplatin or carboplatin
  • For subjects to receive pemetrexed, planned to receive vitamin B12 and folate per pemetrexed approved labeling
  -  Radiographically evaluable (measurable or non-measurable) disease (according to modified RECIST 1.1 criteria
  -  Other inclusion criteria may apply
  Exclusion Criteria:
  -  Known presence of documented sensitizing epidermal growth factor receptor (EGFR) activating mutation or EML4-ALK translocation (screening following local standards, but strongly encouraged in non-squamous histology)
  -  Known brain metastases (systematic screening of patients not mandatory)
  -  Any prior systemic therapy (before randomisation) for the treatment of NSCLC (including chemoradiation), except if for non-metastatic disease and was completed at least 6 months prior to randomization
  -  Planned to receive bevacizumab
  -  Significant dental/oral disease, including prior history or current evidence of osteonecrosis/ osteomyelitis of the jaw, or with the following:
  -  Active dental or jaw condition which requires oral surgery
  -  Non-healed dental/oral surgery
  -  Planned invasive dental procedures for the course of the study.

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: Study of Psychopathological Characteristics of Patient Smoking in Thoracic Oncology

Summary: Persistent smoking after lung cancer has been the subject of medical, therapeutic and epidemiological publications for twenty years of research. Continued persistent smoking is all the more a problem for oncologists as there is evidence that smoking cessation, with lung cancer, gives therapeutic benefit. Quitting smoking can improve the response to treatments (chemotherapy, radiotherapy, surgery), quality of life and overall survival. However many patients refuse adhesion to tobacco cessation. Daily practice leads us to the hypothesis that adhesion differences aren't related to the denial of medical information, nor to resignation or to nicotine dependence. Patients who continue smoking seem to face a form of impossibility to wean. Cigarette seems to be felt as a part of their body in their narration and description of their body image.


Eligibility: Inclusion Criteria:
  -  Men and women aged 18 years or older
  -  Patient affiliated to a social security system
  -  Patient who has signed and dated informed consent, written before all procedures related to the study
  -  Patient who has received the results of the previous mandatory medical examination
  -  Patient who has been diagnosed with lung cancer, regardless of the histological type of the cancer
  -  Patient who maintains an active smoking at the time of inclusion
  -  Patient who has smoked at least one cigarette in the previous year of inclusion
  -  Patient who is being treated for lung cancer (surgery, chemotherapy, radiotherapy) and not another form of cancer
  -  Tobacco consumer's only by smoke inhalation
  -  Tobacco consumer's or tobacco associated with cannabis
  Exclusion Criteria:
  -  Major patient under guardianship or curatorship or maintenance of justice
  -  Patient deprived of his liberty or in an emergency situation
  -  Patient with a Performance Statut(OMS) higher than 2 and/or with a psychiatric disorder like " schizophrenia and other psychotic disorders " (DSM IV)
  -  A palliative care patient
  -  Patient who began smoking during his diagnostic examination or after the diagnosis of cancer
  -  A pregnant or breastfeeding woman
  -  Patient in an exclusion period

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: Immune Response in Lung Cancer

Summary: This study is designed to evaluate the importance of the immune cells localization (distribution) between malignant tumor islets and surrounding stroma and to investigate the associations between these immune cells as well as cytokines and clinicopathological and prognostic factors of non-small cell lung cancer (NSCLC) patients.


Eligibility: Inclusion Criteria:
  -  Eastern Cooperative Oncology Group (ECOG) score of 0-1
  -  Patients with histologically documented non-small cell lung cancer
  -  Control group - patients without non-small cell lung cancer
  -  Written (signed) Informed Consent to participate in the study
  Exclusion Criteria:
  -  Any other malignancies within 5 years
  -  Any unstable systemic disease (including active infections, significant cardiovascular disease)
  -  Prior chemotherapy or radiotherapy
  -  Autoimmune disease
  -  Nursing or pregnant women

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 Roles of Age, Comorbidity, and Telomere Length in Lung Cancer Treatment and Prognosis

Summary: The investigators hypothesize that the age-adjusted telomere length in lung cancer patients before chemotherapy may be correlated to comorbidity status and predict outcome. The change of telomere length shortening after chemotherapy may relate to treatment side effect and treatment response.

Detailed description: Except chemotherapy, telomere shortening were also related to a variety of cellular stress, including hydrogen peroxide, UV, and x-irradiation, transforming growth factor-beta, overexpression of oncogenes such as Ha-Ras. The cellular stress induced telomere shortening and/or telomere dysfunction and promote accelerated senescence in normal and malignant cells. Oxidative stress, which presented in several chronic inflammatory diseases, such as atherosclerosis, coronary artery disease, and chronic obstructive airway disease, was also found to be correlated with telomere shortening.

Eligibility: Inclusion Criteria:
  1. Patients who are newly diagnosed as lung cancer and prepared for scheduled chemotherapy.
  2. The diagnosis is based on pathology via surgical specimen, or biopsy; or cytology via lung, lymph node aspiration or effusion study.
  Exclusion criteria:
  includes clinical diagnosis of lung cancer without pathology or cytology proving, combined with other type malignancy, and expected short survival time less than one month.

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: Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions

Summary: 1. Protocol Title - A Comparison of Epidural Analgesia with Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study
  2. Purpose of the Study - This prospective randomized study will enroll 200 patients undergoing elective Lumbar Spinal Fusion at Duke University Hospital. The primary objective is to determine the effect of epidural analgesia, as compared with standard care, on post-operative analgesia.
  Hypothesis:
  The investigators hypothesize that patients undergoing Lumbar Spinal Fusion surgery with epidural catheter placement will have superior post-operative analgesia compared to patients undergoing standard care.


Eligibility: Inclusion Criteria:
  -  Adult patients who are scheduled for elective Transforaminal Lumbar Interbody Fusion surgery
  Exclusion Criteria:
  -  Baseline cognitive deficits sufficient to make objective pain self-assessments unreliable in the estimation of the Study Investigators.
  -  Inability to follow directions or comprehend the English language.
  -  Females who are pregnant as determined by positive pregnancy test on or before the day of surgery.
  -  Prisoners.
  -  Patient refusal to provide informed consent.
  -  Allergy to amide local anesthetics (lidocaine, bupivacaine, ropivacaine).

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 Pharmacogenomics Research of EGFR-TKIs,Gefitinib and Erlotinib, in Non-small Cell Lung Cancer(NSCLC)Treatment

Summary: For patients of advanced NSCLC (non small cell lung cancer) , Individualized cancer therapy has been widely accepted since the success of crizotinib administration based on EML4-ALK fusion gene detection and gefitinib and erlotinib administration based on EGFR-TKIs sensitive mutations.From clinical points of view ,individual differences often occur between different patients, leading diverse effect in ADR and drug effect.Meanwhile ,the drug effect and adverse drug reaction was significantly influenced by the pharmacokinetic factors and pharmacodynamic factors.In this research ,we try to establish a more sensitive method to detect sensitive mutations in plasma and discover the correlation between somatic and germline mutations , trough concentration and EGFR-TKI drug effect, the association between ADME-associated SNP ,trough concentration and EGFR-TKI adverse effect .Furthermore, in vivo and in vitro research is also crucial for rational explanation for these clinical phenomenon.

Detailed description: The ADME-associated SNPs included are CYP3A4,CYP3A4,CYP1A1,CYP2D6, ABCB1,ABCG2 and so on .The somatic mutations included are EGFR ,K-RAS ,ALK and so on

Eligibility: Inclusion Criteria:
  The main patient entry criteria included: age≥ 18 years ; histologically and cytologically proved NSCLC; Eastern cooperative oncology group performance status (ECOG PS)≤2; adequate hematological , renal, and hepatic functions. Exclusion Criteria:
  uncontrolled systemic disease ,any evidence of clinically active interstitial lung diseases, and other chemotherapy at the time of inclusion. The protocol was approved by the Ethical Committee of Cancer Center of Sun Yat-Sen University (CCSU), and written informed consent was obtained form each patient.

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: Circulating Fibrocytes in Non-small Cell Lung Cancer.

Summary: The investigators will collect fibrocytes (CD45+Col-1+) in patients with non-small cell lung cancer (NSCLC). The investigators hypothesize that patients with NSCLC experience expansion of immunosuppressive fibrocytes, which are predicted to augment tumor growth by mediating immune escape in NSCLC patients.

Detailed description: Fibrocytes have been described in both mice and humans, where they bear a hematopoietic progenitor phenotype (CD45+Col-1+). Fibrocytes have previously been described in murine cancer, implicated as mediators of tumor immune escape. In this study, the investigators will collect fibrocytes including CD45+Col-1+ expression. The cells express indoleamine oxidase, which is primarily responsible for their immunosuppressive properties. The investigators hypothesize that patients with non-small cell lung cancer experience expansion of immunosuppressive fibrocytes, which are predicted to augment tumor growth by mediating immune escape in non-small cell lung cancer patients.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
  Exclusion Criteria:
  -  Combination of other malignancy.
  -  Age less than 20 years (not include 20 years).
  -  Pregnancy.

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: Determinants of Intensity of Care of Lung Cancer Patients With Organ Failure

Summary: Investigators will evaluate determinants of the patients' care type : palliative, medical or intensive care. The place of patient or family on care's decision will be noticed. Investigators will evaluate 3 month-survival and patients' feelings (visit with a psychologist) according to type of care they benefited.

Detailed description: Two hundred patients have to be enrolled in 2 years in the Grenoble Teaching Hospital and in the Saint Louis hospital in Paris between November 2010 and November 2012. Each lung cancer patient with at least one organ failure, admitted in emergency, thoracic oncology or directly in ICU will be included.
  The objectives are to identify patients' characteristics associated with proposition for intensive care unit admission and those associated with the decision of intensive care unit admission.

Eligibility: Inclusion Criteria:
  -  lung cancer
  -  Organ failure
  Exclusion Criteria:

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: Phase 3 Study of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Late-stage Non-squamous Non-small-cell Lung Cancer

Summary: The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer.


Eligibility: Key Inclusion Criteria:
  -  Male or female at least 18 years of age
  -  Histologically or cytologically confirmed and documented stage IIIb/IV non-squamous NSCLC according to the American Joint Committee on Cancer Staging Manual (7th Edition)
  -  Radiographic disease recurrence or progression during or after front-line platinum-based doublet chemotherapy. For patients with known epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK) translocations, appropriate targeted treatment should have been used. Mutation testing is not required.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  -  Adequate hematologic, renal and hepatic function
  Exclusion Criteria:
  -  Squamous, small cell, carcinoid, adenosquamous, large-cell neuroendocrine, or mixed histology containing small-cell or squamous-cell NSCLC
  -  Known history of bleeding disorders, eg, von Willebrand disease or hemophilia
  -  Cavitary tumors or tumors invading or abutting large blood vessels
  -  Clinically significant bleeding such as gross hematuria, GI bleeding, and hemoptysis within the 6 months before screening
  -  Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months of screening
  -  Grade 2 or higher peripheral neuropathy

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: Comparison of qPCR to IHC and FISH for Detection of ALK Fusion Mutations in FFPE Tissue From NSCLC Patients

Summary: The anaplastic lymphoma kinase gene(ALK) is mutated approximately 5% of non-small cell lung cancers. Testing for this gene is important because there are drugs known as ALK inhibitors that have been shown to significantly delay the progression of ALK-mutated lung cancers. There are a number of ways to test for the presence of the ALK gene in lung cancer biopsy tissue. One method involves making slides and staining them to detect the ALK protein. This is called immunohistochemistry. Another method called fluorescence in situ hybridization(FISH)is used to detect rearrangements of the ALK gene associated with lung cancer. Although both these tests are widely used to test for ALK gene abnormalities, the techniques may not always find the ALK gene mutation because they are not sensitive enough or not enough cancer cells are present in the lung biopsy.
  This study is being performed to determine if a technique called quantitation polymerase chain reaction (qPCR) is as accurate or better at finding the ALK gene mutation in lung cancer biopsy tissue.


Eligibility: Inclusion Criteria:
  -  You have a confirmed diagnosis of non-squamous, non-endocrine non-small cell lung cancer.
  -  Your cancer biopsy has sufficient cancer cells to be tested for the (Epidermal Growth Factor Receptor (EGFR) mutation, the ALK fusion gene abnormality and the research ALK testing.
  -  Your lung cancer biopsy is determined not to have a mutation in the EGFR gene.
  -  You are 19 years old or older.
  -  You fully understand the study and give informed consent to participate as demonstrated by signing the consent.

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: Corticospinal Excitability and Rehab in Knee Osteoarthritis

Summary: To determine differences in thigh muscle function in individuals with and without knee arthritis, and also determine the effectiveness of common physical therapy interventions on clinical and patient oriented outcomes.

Detailed description: The primary objective of the proposed research evaluates the concurrent changes in corticospinal excitability and central sensitization of pain pathways for their influence on quadriceps voluntary activation. A secondary objective is to establish the feasibility of an intervention study to determine if changes in the excitability of these supraspinal motor and sensory processes can be modified by physical therapy interventions targeting pain and muscle strengthening. We hypothesize that patients with knee osteoarthritis will show measurable deficits in quadriceps voluntary activation that can be explained by lower levels of corticospinal excitability and increased pain sensitization. A 1 week physical therapy intervention will improve voluntary activation and reduce pain with concurrent changes in underlying motor and sensory processes. We further hypothesize that part of this improvement will be attributed to positive treatment expectation.

Eligibility: Inclusion Criteria:
  -  Age 19-65
  -  Grade I or II knee Osteoarthritis confirmed by radiographs or other imaging and at least one of the following:
  -  Age > 50 years old
  -  Morning stiffness < 30 minutes
  -  Crepitus
  -  Meet at least 3 of 6 diagnostic criteria for osteoarthritis:
  -  Age > 50 years old
  -  Morning stiffness < 30 minutes
  -  Crepitus
  -  Bony tenderness
  -  Bony enlargement
  -  No palpable warmth
  Exclusion Criteria:
  -  BMI > 30
  -  History of traumatic spine or lower extremity injury within the last 6 months
  -  Previous adverse reaction to electrical stimulation (i.e. burns or hypersensitivity)
  -  Cardiac pacemaker
  -  Metal implants in head
  -  Current pregnancy
  -  Neurological disorders
  -  History of seizures
  -  Unable to give consent or understand the procedures of this study

Relevance to patient case: not relevant