araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Duke Lupus Registry

Summary: Lupus is a systemic autoimmune disease that can present with many varied symptoms, including joint pain, fevers, kidney disease, and rashes. Lupus can affect anyone, but it is most common in younger women.
  The Duke Lupus Registry will collect information and blood samples from patients with lupus (systemic lupus erythematosus or cutaneous lupus) seen in the Duke Rheumatology clinics. The goal of this Registry is to understand how lupus changes over time so that we can improve the treatment of patients with lupus.

Detailed description: The Duke Lupus Registry is a prospective cohort comprised of patients with lupus seen in the Duke Rheumatology clinic.
  The Duke Lupus Registry has two main purposes:
  1. Improved patient care. By following disease activity scores and medication usage, we expect to improve our care of the patients seen in clinic.
  2. Future research on lupus outcomes. This may encompass a broad array of areas, including but not limited to cardiovascular health, pregnancy and fertility, infections, medication use, quality of life, and depression.
  At each office visit, patients will complete a questionnaire, physicians will measure lupus activity, and patients may be asked to provide a small blood sample. Patients will not be required to make extra visits to Duke in order to participate -- all paperwork and blood draws will occur during a regularly scheduled office visit with the physician.

Eligibility: Inclusion Criteria:
  -  Diagnosis of Systemic Lupus Erythematosus or Cutaneous Lupus
  -  Patient of a rheumatologist at Duke University Medical Center
  Exclusion Criteria:
  -  Inability to travel to Duke for follow-up visits
  -  Inability to speak English
  -  Not able to provide informed consent

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Duke Autoimmunity in Pregnancy Registry

Summary: It is difficult to predict how a women with an autoimmune disease will do during pregnancy. Some women will improve, others will worsen. Some pregnancies progress normally and others become very complicated.
  The Duke Autoimmunity in Pregnancy (DAP) Registry will enroll women with autoimmune diseases, such as lupus, rheumatoid arthritis, scleroderma, and Sjogren's syndrome who wish to become, or already are, pregnant. We will follow these women throughout pregnancy to better understand how their autoimmune disease affects their pregnancy, and vice versa.

Detailed description: Women with a systemic autoimmune disease that would be followed by a rheumatologist will be included in this study.
  All women will be seen every 4-6 weeks throughout pregnancy. At each visit, women will complete a questionnaire, the physician will determine the current level of disease activity, and a blood sample will be taken. For women with lupus and healthy women, and additional visit will occur at the start of the 3rd trimester for a closer evaluation of predictors of preterm birth.
  This is not an intervention study. Women will not be given experimental medication. All recommendations for treatment and monitoring will be made based on the best available data with input from the treating obstetrician.
  Women in this Registry are not required to be seen by Duke Obstetrics nor to deliver at a Duke Hospital.

Eligibility: Inclusion Criteria:
  -  18 years of age or older
  -  Desire for pregnancy within 6 months or currently pregnant
  -  Women with systemic autoimmune disease, including:
  -  Lupus (systemic lupus erythematosus or cutaneous lupus)
  -  Antiphospholipid Syndrome or positive antiphospholipid antibodies
  -  Rheumatoid Arthritis
  -  Scleroderma (systemic sclerosis)
  -  Sjogren's Syndrome
  -  Inflammatory Arthritis (including Psoriatic Arthritis and Ankylosing Spondylitis)
  -  Undifferentiated Connective Tissue Disease (UCTD)
  -  Vasculitis
  -  Myositis (Polymyositis or Dermatomyositis)
  -  Positive Ro/SSA or La/SSB antibodies
  Exclusion Criteria:
  -  Unable to speak English
  -  Unable to provide informed consent
  -  Unable to travel to Duke University for follow-up visits

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: A Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer

Summary: Part 1 is complete. Part 2 is a multi-center, randomized, double-blind, placebo-controlled, phase 2 segment that will commence upon identification of the maximum tolerated dose in part 1. The Primary objective of Part 2 of the study is to estimate efficacy in combination with carboplatin and paclitaxel. Subjects will be randomized at a 1:1:1 ratio to 1 of 3 treatment arms. Subjects in each of the 3 arms will receive up to 6 cycles of paclitaxel/carboplatin (at the same dose and schedule in part 1) in combination with either AMG 655 at the maximum tolerated dose (Arm 1), AMG 655 at a lower dose (Arm 2), or AMG 655 placebo (Arm 3) IV Q3W. Randomization will be stratified by ECOG (0 or 1) and disease stage (IIIb or IV/recurrent).


Eligibility: Inclusion Criteria:
  -  Disease Related
  -  Histologically or cytologically confirmed non-small cell lung cancer.
  -  Subjects must have advanced non-small cell lung cancer defined as stage IIIB with malignant pleural effusion or stage IV or recurrent disease.
  -  Planning to receive up to 6 cycles of chemotherapy
  -  Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Demographic
  -  Men or women > 18 years of age Ethical
  -  Adequate Hematological, renal, hepatic and coagulation function General
  -  Plan to begin protocol specific therapy < 7 days after enrollment/randomization
  Exclusion Criteria:
  -  Disease Related
  -  Untreated or symptomatic central nervous system metastases. Subjects with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastasis and the subject is clinically stable and off corticosteroids for at least 14 days before enrollment/randomization.
  -  Prior chemotherapy as follows:
  -  Any prior chemotherapy for advanced non-small cell lung cancer
  -  Any prior adjuvant chemotherapy for non-small cell lung cancer < 52 weeks prior to enrollment/randomization. Adjuvant chemotherapy completed > 52 weeks prior to randomization is permitted.
  -  Any prior chemoradiation.
  -  Central (chest) radiation therapy < 28 days prior to randomization, radiation therapy for peripheral lesions < 14 days prior to enrollment/randomization
  -  Other abnormal medical conditions
  -  Documented myocardial infarction or unstable/uncontrolled cardiac condition
  -  History of arterial thrombosis, pulmonary embolus, deep vein thrombosis or hemorrhagic disorders
  -  Major surgical procedure < 30 days prior to enrollment/randomization or not yet recovered from prior major surgery, Minor surgical procedure < 7 days prior to enrollment/randomization or not yet recovered from prior minor surgery

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

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: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Summary: This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC experiencing disease progression after failure of platinum-based chemotherapy.Eligible patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on study treatment is until disease progression ,and the target sample size is 500+ individuals.


Eligibility: Inclusion Criteria:
  -  adult patients >=18 years of age;
  -  histologically documented, locally advanced or recurrent or metastatic NSCLC;
  -  measurable disease;
  -  disease progression during 1-4 cycles of platinum-based chemotherapy.
  Exclusion Criteria:
  -  any other malignancies within the last 5 years;
  -  unstable systemic disease.

Relevance to patient case: possibly relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

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: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

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: possibly relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene

Summary: The purpose of this research study is to:
  -  see if gefitinib pills can shrink Stage 1 or 2 non-small cell lung cancers before surgery
  -  see if your non-small cell lung cancer has a mutation in a certain part of the EGFR gene
  -  see if patients whose tumor does shrink with gefitinib treatment are more likely to have a mutation in a certain part of the EGFR gene
  -  see if the pattern of protein expression in the blood is related to the tumor's sensitivity or resistance to gefitinib treatment.
  -  see if expression of certain genes in the tumor are related to the tumor's sensitivity or resistance to gefitinib treatment.

Detailed description: This is a phase II, single institution trial to correlate gefitinib response and mutations in the protein-tyrosine kinase domain of the EGF receptor gene. The study will be conducted in patients with Stage I and II NSCLC who have been determined to be operable and resectable.
  Patients must have 1 or more of the following features: never smoker or smoking history of < 15 pack years and/or features of bronchioloalveolar lung cancer. 50 patients will be enrolled on this study. Treatment will be with gefitinib for at least 21 days before surgery (depending on the timing of the surgery). Patients will discontinue gefitinib 2 days before their operation. For patients that demonstrate a radiographic response to gefitinib preoperatively and /or patients with mutations in the protein-tyrosine kinase domain of the EGF receptor gene (identified from the surgical sample), gefitinib will continue for 2 years post-surgery. Patients who do not have evidence of radiographic response or mutations in the protein-tyrosine kinase domain of the EGF receptor gene will be removed from the study.

Eligibility: Inclusion Criteria:
  -  Pathologic confirmation of malignancy at Memorial Sloan-Kettering
  -  Patients must have previously untreated stage I or II NSCLC (T11-2N0M0, T1-2N1M0, T3N0M0) and 1 of the following features: never smoker or < 15 pack year smoking history and/or bronchioloalveolar cancer (either pure BAC, BAC with focal invasion or adenocarcinoma with BAC features)
  -  Patients must have been determined to be operable and resectable by the treating thoracic surgeon.
  -  Age >18 years.
  -  Measurable indicator lesions
  -  Ability to understand and the willingness to sign a written informed consent document.
  Exclusion Criteria:
  -  Pregnant or lactating women or women of childbearing potential not using effective contraception. Men participating in the trial must also use effective contraception when sexually active.
  -  Patients may not be receiving any other investigational agents.
  -  Any history of or evidence of interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).

Relevance to patient case: possibly relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Induction Erlotinib Therapy in Stage III A (N2) Non-Small Cell Lung Cancer (NSCLC)

Summary: The purpose of this study is to evaluate the value of induction Erlotinib therapy before thoracotomy or radiotherapy in ⅢA-N2 (confirmed by mediastinoscopy or PET) non-small cell lung cancer (NSCLC) selected by epidermal growth factor receptor (EGFR) gene analysis and initial to explore a new treatment strategy for ⅢA-N2 NSCLC.

Detailed description: Stage IIIA non-small-cell lung cancer (NSCLC) is seen in a relatively heterogeneous group of patients with ipsilateral mediastinal (N2) lymph node involvement. The relative roles of different treatment modalities are not clear. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) may result in dramatic responses in patients with pulmonary adenocarcinoma carrying EGFR activating mutations. In case reports, the efficacy of perioperative EGFR-TKI therapy in patients with locally advanced NSCLC harboring EGFR gene mutations was satisfactory. Although no prospective data support the use of EGFR-TKIs as induction therapy in stage IIIA-N2 NSCLC, their low toxicity profile and the possibility of a rapid tumor response suggests that prospective trials are required. Therefore, this study evaluated the value of induction erlotinib therapy in IIIA-N2 NSCLC selected by EGFR gene analysis and explored a new treatment strategy for this subset. Erlotinib specifically targets the EGFR TK domain, which is highly expressed and occasionally mutated in various forms of cancer. It binds in a reversible fashion to the adenosine triphosphate (ATP) binding site of the receptor.

Eligibility: Inclusion Criteria:
  -  Written informed consent
  -  Histological or cytological documented
  -  Resectable NSCLC of stage IIIA-N2 confirmed by mediastinoscopy or PET
  -  Naive therapy NSCLC
  -  Candidates should be tolerated with induction therapy and thoracotomy with ECOG performance status 0-2, adequate haematological and Hepatic- renal function and qualified lung function
  -  Enough tissue samples to perform gene analysis
  Exclusion Criteria:
  -  Small cell lung cancer
  -  Pregnant or breast-feeding women
  -  Any unstable systemic disease
  -  Patients with exposure to investigational drug therapy or other concurrent anticancer therapy outside of this trial

Relevance to patient case: possibly relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

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: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

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: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Unresectable Advanced and/or Metastatic Non-Small Cell Lung Cancer

Summary: This single arm study will assess the efficacy and safety of erlotinib + gemcitabine in chemotherapy-naive participants with unresectable, advanced and/or metastatic non-small cell lung cancer. Participants will receive erlotinib 150 mg orally (po) daily, in combination with gemcitabine 1000 mg/m^2 intravenously (iv) weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.


Eligibility: Inclusion Criteria:
  -  adult patients, >=18 years of age;
  -  advanced and/or metastatic (stage IIIB/IV) unresectable non-small cell lung cancer;
  -  no previous systemic chemotherapy, radiation therapy or immunotherapy;
  -  Eastern Cooperative Oncology Group (ECOG) >=2.
  Exclusion Criteria:
  -  prior systemic anti-tumor therapy with human epidermal growth factor receptor 1 (HER1/EGFR) inhibitors;
  -  active, non-controlled systemic disease;
  -  any other malignancies within 5 years (except for adequately treated cancer in situ of cervix, or basal or squamous cell skin cancer).

Relevance to patient case: not relevant