araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

Clinical trial: Aerobic and Strength Training Exercise in Improving Fitness and Arm Health During and After Radiation Therapy in Patients With Stage II-III Breast Cancer

Summary: This randomized pilot phase I/II trial studies how well aerobic and strength training exercise works in improving fitness and arm health during and after radiation therapy in patients with stage II-III breast cancer. Aerobic and strength training exercise training during and after radiation therapy may reduce treatment related toxicities and improve adherence to exercise long term in patients with breast cancer.

Detailed description: PRIMARY OBJECTIVES:
  I. To determine the feasibility of conducting an exercise program during and after radiation therapy and to determine what percent of patients will complete the exercise program. (Pilot) II. To determine the percent increase in fitness as measured by the 6 minute walk test in women receiving radiation therapy for breast cancer randomized to an exercise program at 1 year. (Phase II)
  SECONDARY OBJECTIVES:
  I. Percent adherence to exercise at 1 year as measured by the International Physical Activity Questionnaire and exercise logs.
  II. Subjective arm health at 1 year as measured by Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer version 4 (FACT-B+4).
  III. Arm lymphedema at 1 year as measured by arm circumference. IV. Arm range of motion at 1 year as measured by goniometry. V. Quality of life at 1 year as measured by FACT-B+4. VI. Percent increase in arm strength as measured by one repetition maximum at 1 year.
  VII. Change in weight and body mass index (BMI) 1 year after completion of radiation.
  OUTLINE: Patients are randomized to 1 of 2 arms.
  ARM I: Patients receive usual care for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.
  ARM II: Patients undergo a supervised aerobic and strength training exercise session over 40-60 minutes 3 times weekly for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.
  After completion of study, patients are followed up at 1 and 6 months, and 1 year.

Eligibility: Inclusion Criteria:
  -  Stage II-III breast cancer
  -  Prior surgery including lumpectomy or mastectomy and sentinel node biopsy or axillary lymph node dissection
  -  Prior chemotherapy in the neoadjuvant or adjuvant setting
  -  Radiation plan consisting of regional nodal radiation
  -  Must be suitable for an exercise program
  Exclusion Criteria:
  -  Serious underlying medical comorbidity such as uncontrolled hypertension, cardiovascular disease, pulmonary disease, psychiatric illness, or any other condition for which the patient is not approved for exercise by their physician
  -  Physical handicap that would prevent participation in program
  -  Patients with metastatic breast cancer

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

Clinical trial: High-Dose Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Lung Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
  PURPOSE: Phase II trial to study the effectiveness of high-dose combination chemotherapy followed by peripheral stem cell transplantation in treating patients with lung cancer.

Detailed description: OBJECTIVES: I. Evaluate the response rate of high dose chemotherapy followed by autologous peripheral blood stem cell transplantation in the treatment of lung cancer.
  OUTLINE: Patients undergo stem cell harvesting. Patients receive radiation therapy to primary site and metastatic sites, if necessary. Patients receive a high dose of paclitaxel by 24 hour continuous infusion, then stem cells are infused 72 hours later. After a 3-4 week recovery period, patients receive ifosfamide and carboplatin by daily continuous infusion on days -7, -6, -5, and -4. Etoposide is administered by continuous infusion twice daily on days -7, -6, -5, and -4. Stem cells are again infused on day 0. Filgrastim (granulocyte colony-stimulating factor; G-CSF) begins on day 0. Patients may receive radiotherapy following recovery from chemotherapy. Patients are followed weekly for the first 6 months, then periodically for at least 2 years.
  PROJECTED ACCRUAL: This study will accrue 30 patients in 3 years.

Eligibility: DISEASE CHARACTERISTICS: Histologically or cytologically diagnosed lung cancer including the following: Relapsed limited stage small cell lung cancer (SCLC) Limited stage SCLC responding to conventional radiotherapy Extensive stage SCLC Stage IIIB and IV non-small cell lung cancer (NSCLC) Stages II-IIIA NSCLC who are unable or unwilling to undergo surgery but are acceptable candidates for high dose chemotherapy Cryopreserved peripheral blood stem cells with CD34 count greater than 2000/mm3 No untreated or uncontrolled brain metastases
  PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5 times normal SGOT less than 1.5 times normal Renal: Creatinine clearance greater than 50 mL/min Pulmonary: Left ventricular ejection fraction greater than 45% DLCO greater than 40% Other: Not pregnant or lactating No medical or psychiatric illness preventing informed consent or intensive treatment
  PRIOR CONCURRENT THERAPY: Concurrent chemotherapy allowed if no evidence of disease progression

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

Clinical trial: Two Rebeccamycin Analogue Regimens in Treating Patients With Advanced or Recurrent Non-small Cell Lung Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of rebeccamycin analogue is more effective in treating non-small cell lung cancer.
  PURPOSE: Randomized phase II trial to compare the effectiveness of two rebeccamycin analogue regimens in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Compare the efficacy, in terms of response rate, in patients with advanced or recurrent non-small cell lung cancer treated with rebeccamycin analogue via 1 infusion vs 5 daily infusions every 3 weeks.
  -  Compare the response duration in patients treated with these regimens.
  -  Compare the toxicity profiles of these two regimens in these patients.
  OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 or 1 vs 2) and participating center. Patients are randomized to one of two treatment arms.
  -  Arm I: Patients receive rebeccamycin analogue IV over 1 hour on day 1.
  -  Arm II: Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment for both arms repeats every 3 weeks for 6-8 courses in the absence of disease progression or unacceptable toxicity.
  Patients are followed every 3 months.
  PROJECTED ACCRUAL: A total of 36-64 patients (18-32 per arm) will be accrued for this study at a rate of 3-4 patients per month.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven stage IIIB (with pleural effusions), IV, or recurrent non-small cell lung cancer with failure on 1 prior chemotherapy regimen
  -  Measurable disease
  PATIENT CHARACTERISTICS:
  Age:
  -  Not specified
  Performance status:
  -  0-2
  Life expectancy:
  -  At least 12 weeks
  Hematopoietic:
  -  WBC at least 3,000/mm^3
  -  Granulocyte count at least 1,500/mm^3
  -  Platelet count at least 100,000/mm^3
  -  Hemoglobin greater than 10 g/dL
  Hepatic:
  -  Bilirubin no greater than 1.5 mg/dL
  -  AST and ALT less than 2 times normal
  Renal:
  -  Creatinine normal OR
  -  Creatinine clearance at least 60 mL/min
  Cardiovascular:
  -  No New York Heart Association class III or IV heart disease
  Other:
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  No concurrent illness that would preclude study
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  See Disease Characteristics
  -  No more than 1 prior chemotherapy regimen
  -  At least 4 weeks since prior chemotherapy
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Not specified
  Surgery:
  -  Not specified
  Other:
  -  No concurrent combination antiretroviral therapy for HIV

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

Clinical trial: Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer

Summary: RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. CT-guided radiofrequency ablation may be effective treatment for lung cancer.
  PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have refractory or advanced lung cancer.

Detailed description: OBJECTIVES:
  -  Determine the safety and toxicity of radiofrequency ablation in patients with refractory or advanced pulmonary malignancies.
  -  Determine the efficacy of this treatment, in terms of local control, in these patients.
  -  Determine whether CT scan is a reasonable imaging assessment tool for treatment delivery and follow-up in these patients.
  OUTLINE: Patients undergo percutaneous CT-guided radiofrequency ablation directly to the tumor over 2 hours.
  Patients are followed at 1, 3, 6, and 12 months.
  PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility: Inclusion Criteria:
  -  Diagnosis of a primary or secondary intrathoracic malignancy
  -  Any cell type or origin
  -  Involving the intrapulmonary, mediastinal, or pleural/chest wall
  -  Inoperable primary or metastatic cancer to the lung
  -  Refractory to or not amenable to conventional therapy (e.g., surgery, chemotherapy, or radiotherapy)
  -  Single or multiple lesions that are non-contiguous with vital structures or organs such as:
  -  Trachea
  -  Heart
  -  Aorta
  -  Great vessels
  -  Esophagus
  -  Less than 5 cm in largest dimension
  -  Accessible via percutaneous transthoracic route
  -  Hepatic:
  -  Coagulation profile normal

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 2, Randomized, Open-Label Study Of Single Agent CI-1033 In Patients With Advanced Non-Small Cell Lung Cancer

Summary: The purpose of study to determine the activity of CI 1033 against tumors in patients with advanced or metastatic NSCLC who have failed prior platinum-based combination chemotherapy. Another objective is to determine the safety of CI 1033.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically documented diagnosis of progressive or recurrent, locally advanced or metastatic NSCLC; a tumor that expresses at least one member of the erbB family of receptors; failed or relapsed after receiving a platinum-containing regimen as therapy; at least one measurable target lesion as defined by RECIST that has not been irradiated.
  Exclusion Criteria:
  -  Prior exposure to agents that target the erbB receptor family; unknown response to prior platinum-containing chemotherapy regimen; cytotoxic chemotherapy within 3 weeks prior to baseline disease assessments (6 weeks for nitrosoureas or mitomycin); more than 2 prior chemotherapy regimens: immunotherapy or other biologic therapy within 2 weeks prior to baseline disease assessment; prior irradiation to areas encompassing greater than 30% of marrow-bearing bone; brain metastases.

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

Clinical trial: Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

Summary: This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.

Detailed description: This study evaluates the use of Targretin capsules (bexarotene) in combination with Carboplatin and Paclitaxel for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. Every patient receives a platinum-containing chemotherapy every three weeks for at least four chemotherapy cycles (approximately four months). Half of the patients are randomly assigned to receive Targretin capsules once daily in addition to the chemotherapy. The other half is randomized to receive a standard platinum-containing chemotherapy without Targretin capsules.

Eligibility: Patients must have:
  -  Pathologic (histologic or cytologic) confirmation of NSCLC
  -  Stage IIIB with malignant pleural effusion or Stage IV disease
  -  At least one measurable or evaluable NSCLC lesion that has not been previously irradiated unless radiation therapy was more than three weeks prior to entry in the study and the lesion has been shown to have progressed subsequent to the radiation therapy
  -  ECOG performance status 0 or 1
  -  Adequate organ system function
  -  Fasting serum triglycerides that are within the age-adjusted normal range (or normalized with appropriate intervention such as antilipid therapy prior to the initiation of Targretin capsule therapy).
  Patients must be able to complete at least four cycles of combination chemotherapy (i.e., approximately four months)
  Patients must not have had:
  -  Brain metastasis
  -  Prior chemotherapy for NSCLC
  -  Prior platinum-based chemotherapy for any indication

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

Clinical trial: Lupus Genetics Studies

Summary: The Lupus Genetics Studies and Lupus Family Registry & Repository are working to find the genes that reveal the causes of systemic lupus erythematosus (SLE, or lupus). The study is enrolling families of all ethnic backgrounds from the United States, Canada, Puerto Rico, and the Virgin Islands that have one or more living members diagnosed with SLE.

Detailed description: SLE is an often crippling and potentially fatal autoimmune disease that is nine times more prevalent in women than in men, and four times more likely to affect African American females than Caucasian females. It is suspected that a genetic predisposition along with environmental factors contribute to the clinical manifestation of SLE. The Lupus Genetics Studies consist of several familial SLE studies, including the Lupus Family Registry & Repository (LFRR, formerly known as the Lupus Multiplex Registry & Repository, or LMRR). The Lupus Studies enroll families of all ethnicities with one or more members diagnosed with systemic lupus to determine what genes contribute to the development of the disease.
  Additionally, the Lupus Family Registry & Repository is the largest repository of its kind in North America. In addition to the research done on site, the Repository serves as a national resource for scientists interested in conducting research on SLE and families either simplex or multiplex for lupus. Data, serum samples, and DNA samples are available to researchers. By collecting families in which two or more living individuals have been diagnosed with SLE, the study is utilizing the genetic link between the affected family members to discover disease-associated genes.
  Records will be requested from the patients' treating physicians to document various lupus symptoms and related problems. One-time blood samples will be collected from the patients as well as from certain family members and an unrelated volunteer. There is no cost to participate and the study pays for sample draws and shipping.

Eligibility: Inclusion Criteria:
  -  Families in which one or more living members have been diagnosed with systemic lupus erythematosus

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 Research Registry for Neonatal Lupus

Summary: Women with lupus and other related disorders produce certain antibodies in the blood. Some women have these antibodies even if they have not yet developed symptoms of lupus or Sjogren's syndrome. When these women become pregnant, they may pass the antibodies to their infants. The infants may then develop a disease called neonatal lupus. The symptoms of neonatal lupus include an abnormally slow heart beat (heart block) and a skin rash. This registry collects information on women and infants affected by neonatal lupus as well as other family members who may be healthy.

Detailed description: Neonatal lupus is a disease seen in babies born to mothers who have antibodies to SSA/Ro and/or SSB/La proteins. The mother may have systemic lupus erythematosus, Sjogren's syndrome, or be otherwise healthy. Heart block and a characteristic skin rash are the primary manifestations of neonatal lupus.
  The Research Registry for Neonatal Lupus was initiated in 1994 to help basic scientists and clinicians better understand the cause of neonatal lupus and discover a cure. The Research Registry is a central repository of patient information, sera, and DNA. The Registry provides blood samples (kept anonymous) to scientists studying neonatal lupus. Information from the registry forms the basis of family counseling and tracks important data such as recurrence rates in subsequent pregnancies and the effects of treatments. The Research Registry also serves as an educational resource for women who are eager to learn about this disease.
  Women with a child affected by neonatal lupus may enroll in the Registry. Women can be self referred or referred by their doctors. Siblings of women with a child affected by neonatal lupus, fathers and maternal grandparents of children with neonatal lupus, and unaffected siblings of a child with neonatal lupus are also invited to participate in this study. All information on the mother and her family is confidential; only nonidentifying information will be provided to researchers. Women interested in the registry will be sent articles and educational materials about neonatal lupus, a consent form for the Registry, and an enrollment questionnaire. Participants will be asked to sign a medical records release form. Participants will also be asked to donate a blood sample for antibody testing and DNA isolation.

Eligibility: Inclusion Criteria:
  -  Mother with antibodies to SSA/Ro, SSB/La, or ribonucleoproteins (RNP) OR Child of mother with such antibodies who has neonatal lupus (congenital heart block, transient skin rash, and/or hepatic or hematologic manifestations) OR Father of neonatal lupus-affected child OR Maternal grandparents of neonatal lupus-affected child OR Maternal aunts and uncles of neonatal lupus-affected OR Unaffected siblings of neonatal lupus-affected child

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

Clinical trial: Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer

Summary: The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advanced or metastatic breast cancer.


Eligibility: Inclusion criteria:
  -  Signed Informed Consent
  -  Able to swallow an oral medication
  -  Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram
  -  Adequate kidney and liver function
  -  Adequate bone marrow function
  -  Tumor tissue available for testing
  -  Prior adjuvant or neoadjuvant therapy is permitted with an anthracycline or anthracenedione-containing regimen however, subjects must have had cumulative doses of less than 360 mg/m2 of doxorubicin, 720 mg/m2 of epirubicin, or 72 mg/m2 of mitoxantrone
  -  No Her2/neu overexpression in tumor tissue tested or status unknown if tissue has never been tested
  Exclusion criteria:
  -  Prior treatment regimens for advanced or metastatic breast cancer.
  -  Pregnant or lactating
  -  Conditions that would effect the absorption of an oral drug
  -  Active infection
  -  Brain metastases
  -  Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor.
  -  Known hypersensitivity to Taxol or excipients of Taxol
  -  Peripheral neuropathy of Grade 2 or greater is not permitted
  -  Severe Cardiovascular disease or cardiac disease requiring a device.
  -  Serious medical or psychiatric disorder that would interfere with the patient's safety or 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: A Study to Evaluate Tarceva in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Summary: This is a Phase IIIb, multicenter, open-label trial of daily oral Tarceva in patients with advanced (inoperable Stage IIIb or IV) NSCLC who have progressed following standard chemotherapy treatment.


Eligibility: Inclusion Criteria:
  -  Written (signed) informed consent(s)
  -  Inoperable and incurable, locally advanced, recurrent or metastatic NSCLC
  -  Relapse following standard chemotherapy (combination chemotherapy such as two-drug combination chemotherapy, or a single-agent chemotherapy agent for elderly or poor performance status patients)
  -  Age >=18 years
  -  ECOG performance status of 0 to 3
  -  Recovered from the toxic effects of prior therapy
  -  Able to comply with study and follow-up procedures
  -  Able to take oral medication
  -  Use of an effective means of contraception (for patients with reproductive potential)
  -  Granulocyte count >=1.0 x 10^9/L
  -  Platelet count >=75 x 10^9/L
  -  Serum bilirubin <1.5 x upper limit of normal (ULN)
  -  SGOT (AST) <2 x ULN unless elevation is clearly due to liver metastases; then SGOT (AST) must be <5 x ULN
  -  Serum creatinine <=1.5 mg/dL
  Exclusion Criteria:
  -  Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, myocardial infarction within the last 6 months, hepatic, renal, or metabolic disease)
  -  Prior therapy with any systemic HER1/EGFR small molecule inhibitor, including gefitinib (Iressa), erlotinib (Tarceva), or other investigational agents in this class
  -  History of another malignancy in the past 2 years unless the malignancy has been adequately treated and is associated with a 5-year anticipated survival of >=90%
  -  Known central nervous system (CNS) metastases that have not yet been definitively treated with surgery and/or radiation or that are symptomatic or unstable
  -  Nursing mothers or pregnant females

Relevance to patient case: not relevant