araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Gene Polymorphisms and Symptoms in Lung Cancer Patients

Summary: Primary Objectives:
  -  Construct a prospective cohort of patients diagnosed with lung cancer and dispositioned for treatment and collect information on symptoms and symptom treatments at baseline and on follow-up.
  -  Develop preliminary statistical models incorporating genetic data (which will be obtained from an existing protocol, CPN 91-001, Margaret Spitz), disease-related variables (e.g., stage of disease, location of tumor), clinical health status (e.g., performance status, comorbid conditions), and sociodemographic characteristics (e.g., age, sex, race) for predicting the risk of severe and persistent symptoms.
  Analytical aim: To determine if symptoms (e.g., fatigue, depression, lack of appetite) will differ in severity by IL-6 gene polymorphisms (-174G/C, -597G/A, -572G/C, -373An/Tn).
  This study (NIH-CA109043, Reyes-Gibby, 2004-2009) builds upon an NIH-funded (NIH-CA55769, Spitz, 2003-2008) study of the molecular epidemiology of lung cancer.

Detailed description: If you agree to take part in this study, upon being admitted for treatment, you will be asked about your symptoms (how severe they are and to what degree they affect your day-to-day functioning).
  You will be asked to fill out a symptoms questionnaire each time you are at the clinic for your treatment and for your follow-up visits. The questionnaire will take about 5 to 10 minutes to complete each time.
  You may also be contacted at home so that researchers can follow-up on your experience with symptoms (only if you are not able to come to the clinic for your chemoradiation treatment or follow-up visits). If you are contacted by phone, the call should last about 5 to 10 minutes each time.
  Researchers will also try to collect some of your leftover blood (that was already drawn and stored for research studies) from a previous lung cancer study (Ecogenetics of Lung Cancer) that you participated in at M. D. Anderson. Researchers will use your leftover blood sample to look at certain genes in your blood that may affect your symptoms. If you did not have blood collected in the previous lung cancer study, you will have a blood sample (one tablespoon) drawn when you first agree to participate in this study.
  This is an investigational study. Up to 320 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility: Inclusion Criteria:
  -  Patient has lung cancer and is being treated at M. D. Anderson.
  -  At least 18 years of age
  -  Currently living in the United States
  -  Enrolled in CPN 91-001 (Molecular epidemiology of lung cancer)
  -  English or Spanish speaking
  Exclusion Criteria:
  -  Patient is unable to understand the intent of the study.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Clinical Early Stages of Non-small Cell Lung Cancer

Summary: Randomized Phase III trial of surgery alone or surgery plus preoperative Gemcitabine-Cisplatin in clinical early stages of non-small cell lung cancer


Eligibility: Inclusion Criteria:
  -  Patients with early stage NSCLC

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Microarray Analysis of Gene Expression and Identification of Progenitor Cells in Lung Carcinoma

Summary: This study will investigate gene expression profiles in normal human lung tissue, lung carcinoma and metastatic tumor to the lung. The expression of up to 20,000 genes in a given lung tissue sample will be examined by cDNA microarray analysis and compared to normal lung tissue. In addition, we hope to identify a particular subset of lung cancer cells with an enhanced capacity for proliferation and self-renewal , analogous to the stem cells recently identified for certain types of leukemia, breast cancer and brain tumors.


Eligibility: Inclusion Criteria:Adults with non small cell lung cancer
  Exclusion Criteria:NA

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: OBELIX Study: A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Cancer of the Colon or Rectum.

Summary: This single arm study will evaluate the efficacy and safety of a first-line regimen of Avastin and XELOX (oxaliplatin + Xeloda) in patients with metastatic cancer of the colon or rectum. Patients will receive 21-day cycles of treatment, comprising Avastin 7.5mg/kg iv on day 1, oxaliplatin 130mg/m2 iv on day 1, and Xeloda 1000mg/m2 po twice daily on days 1-14, for a maximum of 6 months. Patients with stable disease or complete or partial response may continue on Avastin therapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility: Inclusion Criteria:
  -  adult patients, >=18 years of age;
  -  locally advanced or metastatic colorectal cancer;
  -  no previous treatment with chemotherapy for metastatic disease;
  -  at least one measurable lesion.
  Exclusion Criteria:
  -  radiotherapy to any site within 4 weeks before study;
  -  untreated brain metastases or primary brain tumors;
  -  clinically significant cardiovascular disease;
  -  chronic daily treatment with high dose aspirin (>325 mg/day);
  -  other co-existing malignancies or malignancies diagnosed within last 5 years.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Lung Cancer Location: a Repository

Summary: The purpose of this repository is to prospectively examine subjects with known or suspected lung cancer to determine the extent of mediastinal lymph node involvement with respect to primary lung cancer location. The data collected in this repository may be used to influence our current standard of care and streamline indications for EUS.


Eligibility: Inclusion Criteria:
  -  Subjects undergoing EUS evaluation of a mediastinal mass, or suspected/known lung cancer
  -  Subjects with a prior history of lung cancer
  -  Subjects referred to thoracic surgery for evaluation of a suspected/known lung cancer
  Exclusion Criteria:
  -  Altered mental status that would prohibit the giving and understanding of informed consent
  -  Dementia
  -  Psychiatric illness that would preclude adequate compliance with communication for this protocol
  -  Prisoners

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Registry for Patients With Acquired Resistance to Small Molecule Kinase Inhibitors in Non-Small-Cell Lung Cancer

Summary: The purpose of this study is to try to learn more about how small molecule kinase inhibitors work in treating lung cancer. Some early studies have shown that gefitinib, erlotinib and similar drugs are more likely to work if a particular DNA change (also known as a mutation) is found in a protein that is important in lung cancer. This protein is called the epidermal growth factor receptor (EGFR). Since small molecule kinase inhibitors sometimes stop working, we would like to examine your tumor to learn why these medicines are not working as well. Your tumor will be examined for a variety of things including changes in the DNA of the EGFR. We will also sequence parts of the genes for HER2, HER3, HER4, and KRAS, other proteins thought to be important in lung cancer.

Detailed description: The goal of this protocol is to determine mechanisms of resistance to epidermal growth factor (EGFR) tyrosine kinase inhibitors (EGFR-TKI) in non-small cell lung cancer (NSCLC). A number of trials have shown small molecule kinase inhibitors to be active agents in the treatment of NSCLC [1]. Clinically these drugs have been noted to produce dramatic but infrequent responses. Mutations in the epidermal growth factor receptor have been shown to correlate with sensitivity to gefitinib and erlotinib[2,3]. However, we know that most patients who have initial responses to EGFR-TKI eventually progress. The mechanism of acquired clinical resistance to these inhibitors in patients incompletely understood.
  This is a protocol to study clinical characteristics and biopsy tissue of patients with non-small cell lung cancer who have had previous clinical response to small molecule kinase inhibitors and subsequently experience progression of disease. The tissues and other specimens will be used to carry out laboratory studies to explore the molecular basis of sensitivity and resistance to small molecule kinase inhibitors.

Eligibility: Inclusion Criteria:
  Patients diagnosed with unresectable or metastatic non-small cell lung cancer (NSCLC) and who fulfill the following eligibility criteria will be considered eligible for this study.
  -  Patient must have previously received treatment with small molecule kinase inhibitors targeting at least, in part, EGFR patients may have received other treatments since treatment with small molecule kinase inhibitors including radiation or chemotherapy)
  -  Development of disease progression while actively receiving tyrosine kinase inhibitor
  -  Signed informed consent
  Exclusion Criteria:

Relevance to patient case: definitely relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors

Summary: The purpose of the study is to evaluate the effectiveness of radiofrequency ablation by pathological correlation and to characterize the tissue response after treatment of primary and secondary pulmonary tumors.

Detailed description: Thermal ablation therapy is an increasingly performed technique in the local tumor treatment. Among these techniques, image-guided radiofrequency (RF) ablation attained widespread consideration in the therapy of liver tumors and osteoid osteoma. Promising results of hepatic RF ablation raised expectations to utilize the advantages of image-guided ablation therapy for the treatment of pulmonary malignancies. The purpose of the study is to evaluate the effectiveness of radiofrequency ablation by pathological correlation and to characterize the tissue response after treatment of primary and secondary pulmonary tumors. Computed tomography-guided RF ablation is performed in local or general anesthesia, followed by surgical resection three days later. An analysis of complete RF ablation and a characterization of tissue response is performed by hematoxylin and eosin staining, immunostaining, and electron microscopy. Adverse effects and complications are recorded.

Eligibility: Inclusion Criteria:
  -  Signed informed consent for radiofrequency ablation and surgery
  -  Maximum of 3 lung tumors
  -  Maximum tumor size 5 cm
  -  Must be able to receive standard surgery
  Exclusion Criteria:
  -  Pathological coagulation tests
  -  Pregnant or breast feeding
  -  Maximum tumor size more than 5 cm
  -  Bilateral secondary lung cancer with more than 3 tumors
  -  Inoperable patient

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: A Study of Metronidazole Cream in the Prevention and Treatment of Tarceva (Erlotinib)-Associated Rash

Summary: This study will evaluate the efficacy and safety of metronidazole actavis 1 percent (%) topical cream in the prevention and treatment of rash associated with Tarceva treatment, in participants with non-small cell lung cancer. The first cohort of participants enrolled in the study will be treated twice daily with metronidazole cream on the right side of the face and upper thorax, the same day as they start treatment with Tarceva (150 mg orally daily). The corresponding body parts on the left side will be treated according to local standard procedures (ie, with non-active moisturizing cream). The second cohort of Tarceva-treated participants will only receive twice daily treatment with metronidazole cream if and when they develop rash. In both cohorts, efficacy will be evaluated at Week 2 and Week 4. The anticipated time on metronidazole treatment is less than (<) 3 months, and the target sample size is <100 individuals.


Eligibility: Inclusion Criteria:
  -  non-small cell lung cancer
  -  eligible to start treatment with erlotinib
  Exclusion Criteria:
  -  hypersensitivity to metronidazole

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Modulation of Lung Injury Complicating Lung Resection

Summary: The purpose of this study is to determine whether N-acetylcysteine given intravenously 1 day pre-operatively is effective in preventing inflammation in the lungs, as measured by tests on blood, breath and lung specimens, in patients undergoing surgery to remove a portion of lung.

Detailed description: Acute lung injury occurs following lung resection in about 5% cases, and has a high mortality of around 50%. Management of these patients is largely supportive. Even in patients who do not develop clinical evidence of acute lung injury, markers of inflammation and oxidative stress are present in blood and exhaled breath condensate after lung resection. The purpose of this randomised double-blind placebo-controlled study is to determine whether lung injury can be prevented by pre-administration of N-acetylcysteine.

Eligibility: Inclusion Criteria:
  -  Elective lung resection for cancer
  Exclusion Criteria:
  -  Age less than 18 years
  -  Women of child-bearing age or potential
  -  Known allergy to N-acetylcysteine
  -  Oral steroid in the preceding 1 month
  -  N-acetylcysteine in the preceding 1 month
  -  Unable to receive standardised anaesthetic approach

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: The Effect of Berries on Lung Cancer Tumors

Summary: The purpose of this study is to determine how berries affect cancer tumors in patients with non-small cell lung cancer.

Detailed description: In the United States, more people (161,840 per year) die of lung cancers than of prostate cancer, breast cancer and colon cancer combined. Presently, there are over 43 million current smokers and over 47 million ex-smokers living in the US. Due to the lag time between smoking and the development of cancer, there are significant numbers of ex-smokers and current smokers who may develop lung cancer compared to never smokers.
  Recent studies in animals have shown that berries, given as a dietary supplement, are highly effective against certain types of cancers. In a study involving mice with lung tumors, mice that had consumed a mixture of berries developed fewer tumors and had less tumor growth than mice that did not consume berries.
  The berries used in this study will consist of blueberries, black raspberries, or a mixture of both.

Eligibility: Inclusion Criteria (lung cancer survivors):
  -  men treated for lung cancer, women treated for lung cancer and with no child-bearing potential (hysterectomy, tubal ligation, post-menopausal women)
  Exclusion Criteria (lung cancer survivors):
  -  women who are on hormone replacement therapy
  -  women who are pregnant, or planning for pregnancy
  -  history of lung transplant
  -  prison inmate
  -  inability to take oral medication or food
  -  known or suspected allergy to berries or berry products
  -  HIV patients
  Inclusion Criteria (volunteers):
  -  adult men, adult women with no child bearing potential (hysterectomy, tubal ligation, post-menopausal women)
  Exclusion Criteria (volunteers):
  -  women who are on hormone replacement therapy
  -  women who are pregnant, or planning for pregnancy
  -  history of lung transplant
  -  prison inmate
  -  inability to take oral medication or food
  -  known or suspected allergy to berries or berry products
  -  HIV patients

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Use of Trastuzumab to Induce Increased ER Expression in ER-negative/Low, Her-2/Neu Positive Breast Cancer

Summary: The majority pf breast cancers present as ER-positive, many of which are able to be targeted with multiple hormonal therapies. Altering ER-negative tumors to increase ER expression has the potential to benefit patients by making hormonal therapies a therapeutic option and possibly improving their overall prognosis.


Eligibility: Inclusion Criteria:
  -  Women who have Her-2 positive and ER- negative or ER-low breast cancer that has not metastasized, or spread to other parts of the body, are eligible for the study.
  -  Participants must have had either a core biopsy or incisional biopsy of their breast cancer, but not yet had definitive breast surgery, including lumpectomy or mastectomy.
  -  Participants may not have had a BRCA mutation found on genetic testing.
  -  Participants should have not yet received treatment for their breast cancer, including:
  -  chemotherapy,
  -  hormonal therapy,
  -  trastuzumab.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: A Phase I Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of CUDC-101 in Patients With Advanced Solid Tumors

Summary: This is a phase I, open-label, dose-escalation study of CUDC-101 in patients with advanced and refractory solid tumors. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2(Her2) and histone deacetylase (HDAC). The study is designed to establish the safety, including the maximum tolerated dose, the pharmacokinetics, and the anti-tumor activity of CUDC-101.


Eligibility: Inclusion Criteria:
  -  Subjects with advanced, refractory solid tumors and a histopathologically confirmed diagnosis
  -  Subjects must have no further standard of care options or have refused standard therapy
  -  Measurable or evaluable disease
  -  Age ≥ 18 years
  -  ECOG performance < 2
  -  Life expectancy ≥ 3 months
  -  If female, neither pregnant or lactating
  -  If of child bearing potential, must use adequate birth control
  -  Absolute neutrophil count ≥ 1,500/µL; platelets ≥ 100,000/µL;
  -  Creatinine ≤ 1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60mL/min/1.73m2
  -  Total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2.5x ULN. In subjects with documented liver metastases, the AST/ALT may be ≤ 5x ULN
  -  Prothrombin time ≤1.5x ULN, unless receiving therapeutic anticoagulation
  -  Serum magnesium and potassium within normal limits (may be supplement to achieve normal values)
  -  Subjects with brain metastases are eligible if controlled on a stable dose ≤ 10mg prednisone/day or its equivalent dose of steroids
  -  Able to render informed consent and to follow protocol requirements.
  Exclusion Criteria:
  -  Anticancer therapy within 4 weeks of study entry. Prostate cancer subjects on LHRH hormonal therapy may be enrolled and continue on this therapy.
  -  Use of investigational agent(s) within 30 days of study entry
  -  History of cardiac disease with a New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF), myocardial infarction (MI) or unstable angina in the past 6 months prior to Day 1 of treatment, serious arrhythmias requiring medication for treatment.
  -  Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
  -  The following are permitted but should be used with caution and other suitable agents used if possible:
  -  Subjects receiving concomitant medications metabolized by CYP 3A4 and CYP 2D6
  -  CYP3A4 inducers
  -  CYP3A4 inhibitors
  -  Warfarin

Relevance to patient case: possibly relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Phase I Imaging Study Evaluating Dalotuzumab (MK0646) in Combination With Erlotinib for Patients With Non-Small Cell Lung Cancer (MK-0646-008)

Summary: This study will use imaging to look at tumor response to erlotinib (Part I) and the combination of erlotinib and dalotuzumab (Part II).


Eligibility: Inclusion Criteria:
  -  Patient has locally advanced or metastatic stage IIIB/IV Non-small cell lung cancer
  -  Patient has measurable disease
  -  Patient has accessible tumor and consents to undergo a tumor biopsy [Part II only]
  -  Patient is 18 years of age or older
  -  Patient has a performance status of 0-2 on ECOG scale
  -  Women of childbearing potential have a negative pregnancy test
  -  Patients in Part I must: 1. be a female non-smoker with non-squamous histology who has had one or two prior systemic chemotherapies or 2. have documented EGFR mutation or EGFR gene amplification, regardless of demographic or clinical characteristics, who have had no more than two prior systemic chemotherapies.
  -  Patients in Part II must have had one or two chemotherapy regimens for recurrent or metastatic disease
  Exclusion Criteria:
  -  Patient has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab) within 4 weeks
  -  Patient has not recovered from adverse events from previous therapy within 4 weeks
  -  Patient has received EGFR-TKI inhibitor/anti-EGFR mAb therapy
  -  Patient has received IGF1R-TKI inhibitor/anti-IGF1R mAB therapy
  -  Patient has untreated brain metastases
  -  Patient has had radiotherapy to a field that affects the chest or abdomen, or thoracic surgery within 3 months prior to entering the study
  -  Patient is taking part in another clinical study
  -  Patient abuses drugs or alcohol
  -  Patient is pregnant or breastfeeding
  -  Subject is HIV positive
  -  Patient has active hepatitis
  -  Patient is using growth hormone or growth hormone inhibitors
  -  Patient has poorly controlled diabetes mellitus

Relevance to patient case: definitely relevant