araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Lung Cancer Biomarkers and Screening

Summary: RATIONALE: Screening tests that use biomarkers may help doctors find tumor cells early and plan effective treatment for lung cancer.
  PURPOSE: This clinical trial is studying biomarkers in screening participants for lung cancer.

Detailed description: OBJECTIVES:
  -  Identify and validate biomarkers for the early detection of lung cancer in individuals at low- or high-risk for smoking-related cancers.
  -  Identify preneoplastic cellular changes and lesions in these patients.
  OUTLINE: Participants are stratified according to lung cancer risk status (with or without increased risk).
  Group 1 (screening cohort): Participants complete a questionnaire and undergo pulmonary function testing, multidetector chest CT scan, sputum induction, and phlebotomy.
  Group 2 (rule-out lung cancer): Participants complete the same questionnaire and undergo the same tests and scans as in group 1. Some participants may undergo fiberoptic bronchoscopy based upon CT scan results with transbronchial or endobronchial biopsies. Some participants may undergo lung resection. Tissue samples are collected from surgery or biopsy.
  PROJECTED ACCRUAL: A total of participants will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Screening Cohort
  -  At high- or low-risk for lung cancer
  -  Smoking history ≥ 20 pack years*
  -  With or without workplace exposure to asbestos
  -  NOTE: * Participants with < 20 pack years of smoking are eligible if 50 years of age or older
  -  Rule-Out Lung cancer group
  -  Referred for evaluation of suspicious nodules with 1 of the following diagnoses:
  -  Lung cancer
  -  Nonmalignant nodules (control group)
  PATIENT CHARACTERISTICS:
  -  Not pregnant
  -  No prior malignancy except nonmelanoma skin cancer
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)

Summary: The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes during each infusion will be evaluated.


Eligibility: Key Inclusion Criteria:
  Patients with CVID (Common Variable Immunodeficiency) or XLA (X-linked agammaglobulinemia) who:
  Participated in the Phase III clinical study with intravenous IgPro10 (study number ZLB03_002CR) at 3- or 4- weekly intervals for 12 months (referred to as 'old' subjects)
  OR
  Were ≥ 6 years of age, were on other stable intravenous immunoglobulin therapy (200-800 mg IgG per kg body weight) at 3- or 4-week intervals for at least 6 months, AND were interested in participating in the Phase III clinical study with subcutaneous IgPro20 (study number ZLB04_009CR) (referred to as 'new' subjects)
  Written informed consent
  Key Exclusion Criteria:
  Diagnosis of epilepsia
  Insulin dependent diabetes
  Administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs
  History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Removal of Lung Nodules After Being Marked With a Microcoil

Summary: The objective of this study is to determine if subcentimetre pulmonary nodules can be accurately and safely excised by endoscopic stapling devices after they have been localized using CT and marked with a microcoil device.
  The addition of real-time CT imaging and insertion of platinum microcoil markers to the technique of video assisted thoracoscopic stapled resection of subcentimetre pulmonary nodules, will decrease the rate of open thoracotomies required to completely resect the nodules.

Detailed description: Lung cancer is the most common cause of cancer death for both men and women in the industrialized world. Small cell lung cancer accounts for about 25% of lung cancers and is usually widespread when it first presents. The remaining 75% of lung cancers are collectively termed non-small cell lung cancers. When presentation is by symptoms or incidental discovery, about 50 to 60% of non-small cell lung cancers are parenchymal nodules or masses and 40 to 50% are bronchial or hilar. More than 50% of patients with non-small cell cancer will have distant metastases at the time of diagnosis and only 25% will be potentially resectable for cure.1 Overall survival at five years for lung cancer is approximately 15% and has not significantly improved over the last several decades. Prognosis for lung cancer is affected by many factors but one of the most important is the stage of the disease at presentation. Individuals with peripheral lesions less than 3 cm in diameter (T1) at presentation are ideal candidates for surgical resection and have the best outcomes, with 5-year survival rates as high as 60 to 80%.2 Patients with small subcentimeter pulmonary nodes may have even better survival with resection. Computed tomography can now detect cancers less than 4 mm in diameter, and it has been shown that resection of subcentimetre lung cancers results in a survival rate of up to 85%.3 However, Suzuki et al found 54% of 92 patients undergoing video assisted thoracoscopic excision of subcentimetre nodules, required conversion to a thoracotomy. Forty percent of those nodules were found to be malignant.4 The most common reason for this conversion was failure to localize the nodule using thoracoscopic visualization or palpation. Furthermore, univariate and multivariate analysis of eleven variables revealed that if the distance from the pleural surface was greater than 5 mm, the probability of failure to detect the nodule was 63%.

Eligibility: Inclusion Criteria:
  -  subcentimetre lung nodule
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer

Summary: The goals of this study are:
  -  to determine if the combination of two drugs, motexafin gadolinium and pemetrexed, may be an effective treatment for patients with non-small cell lung cancer (NSCLC) who have had one previous chemotherapy regimen that included a platinum containing drug such as cisplatin or carboplatin.
  -  to assess response to treatment in patients with NSCLC six months after beginning study treatment.


Eligibility: Inclusion Criteria:
  -  18 years or older
  -  Stage IIIb, metastatic, or recurrent NSCLC patients who have received one prior platinum-based chemotherapy regimen
  -  ECOG performance status score of 0 or 1
  Exclusion Criteria:
  -  Laboratory values indicating inadequate function of bone marrow, liver, or kidneys
  -  Symptomatic or uncontrolled brain metastases
  -  Evidence of meningeal metastasis
  -  > 1 prior regimen (not counting adjuvant or neo-adjuvant cytotoxic chemotherapy if completed > 12 months prior to regiment)
  -  Medical condition that would increase risk if treated with motexafin gadolinium or impair ability to complete study procedures and assessments

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Preventing Depression Recurrence in Diabetes

Summary: To study the effectiveness of sertraline (Zoloft) in treating depression in adults with diabetes. The study will also determine whether depressed diabetic patients who have successfully responded to sertraline (Zoloft) are more likely to have depression recur if the sertraline (Zoloft) is discontinued.

Detailed description: Part A: Prevention of Depression Recurrence in Diabetes
  1. To determine the efficacy of maintenance antidepressant medication in preventing or delaying recur-rence of major depression in diabetes.
  2. To determine the relationship of sustained depression remission to social, occupational, and global func-tioning, and to quality of life and compliance with diabetes treatment.
  3. To determine clinical features predictive of depression recurrence in diabetes.
  Part B. Longitudinal Study of the Interrelationship of Glycemic Control and Depression
  1. To determine the effects of depression remission and recurrence on glycemic control.
  2. To determine the efficacy of maintenance antidepressant medication in producing sustained benefits in glycemic control.
  3. To determine the interrelationship of daily mood with blood glucose and the effect of maintenance treatment on this relationship.

Eligibility: Inclusion Criteria:
  -  18-80
  -  Type 1 or Type 2 Diabetes
  -  Screen positive for depression
  Exclusion Criteria:
  -  Are pregnant or lactating
  -  Are known to be hypersensitive to the drug
  -  Have a recent history of myocardial infarction or unstable heart disease
  -  Have severe hepatic disease or renal impairment (serum creatinine > 3 mg/dl)
  -  The subset of patients with psychiatric disorders thought to affect management (e.g., schizophrenia, alcohol and drug dependence) will also be excluded from participation

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Zinc Supplements in Lowering Cadmium Levels in Smokers

Summary: RATIONALE: Zinc supplements may lower cadmium levels in smokers and may help prevent DNA damage.
  PURPOSE: This clinical trial is studying how well zinc supplements work in lowering cadmium levels in smokers.

Detailed description: OBJECTIVES:
  -  Determine whether zinc supplements reduce cadmium levels in smokers.
  -  Measure serum levels of cotinine (a biomarker of smoking), zinc (a marker of compliance), and cadmium (the dependent variable) at 3 pre-supplementation visits and at 6 supplementation visits.
  -  Determine whether serum cadmium levels (adjusted for serum levels of cotinine) decrease during supplementation with VisiVite Smoker's Formula.
  -  Determine if increased cadmium levels in the blood of cigarette smokers can be correlated with decreased mismatch repair.
  -  Determine if administration of zinc-containing supplements reverses cadmium-induced inhibition of mismatch repair.
  OUTLINE: This is an open-label, nonrandomized study.
  Patients receive oral zinc supplements once daily for 12 weeks in the absence of unacceptable toxicity.
  Blood, serum, and urine are collected once weekly for 3 weeks before beginning treatment and in weeks 5, 6, 9, 12, 15, and 17 for biomarker/laboratory analysis. Samples are examined for cadmium, zinc, and cotinine levels by atomic absorption spectrophotometry, expression of mismatch repair proteins (MSH2, MSH6, MSH3, MLH1, and PMS2), levels of messenger RNA by reverse transcriptase-polymerase chain reaction, and microsatellite instability by gel electrophoresis.
  After completion of study therapy, patients are followed for 5 weeks.

Eligibility: DISEASE CHARACTERISTICS:
  -  Currently smoking ≥ 1 pack (20 cigarettes) per day
  -  Baseline cadmium level ≥ 0.5 μg/L
  PATIENT CHARACTERISTICS:
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  No known gastrointestinal upset due to zinc vitamins or lozenges
  PRIOR CONCURRENT THERAPY:
  -  At least 2 weeks since prior and no other concurrent vitamins and zinc supplements

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Depression Screening in Patients With Lung Cancer

Summary: RATIONALE: Screening tests may help doctors find depression in patients with lung cancer, allow doctors to recommend treatment for depression, and improve the patient's quality of life.
  PURPOSE: This randomized clinical trial is studying how well depression screening works when the results are or are not shared with patients with lung cancer and their doctor.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the impact of depression screening in patients with lung cancer when the results of the screening are made available to the patient, the physician, both, or neither on detection of depression, provision of depression treatment recommendations, and the quality of the doctor-patient interaction from the patient's perspective.
  Secondary
  -  Determine psychological and demographic subsets for the impact of depression screening in these patients when the results of the screening are made available to the patient, the physician, both, or neither on the detection of depression, provision of depression treatment recommendations, and the quality of the doctor-patient interaction from the patient's perspective.
  OUTLINE: This is a multicenter, randomized, double-blind, single-blind, factorial study. Patients are stratified according to participating center (Memorial Sloan-Kettering Cancer Center vs University of Kentucky Markey Cancer Center). Patients are randomized to 1 of 4 screening arms.
  -  Arm I (control): Patients complete screening questionnaires about their mood and experience with lung cancer once before and once after a visit with their physician. Neither the patient nor physician receives the screening results before the visit.
  -  Arm II: Patients complete screening questionnaires as in arm I. Only the patient receives the screening results before their visit with the physician; the physician remains blinded to the results.
  -  Arm III: Patients complete screening questionnaires as in arm I. Only the physician receives the screening results before their visit with the patient; the patient remains blinded to the results.
  -  Arm IV: Patients complete screening questionnaires as in arm I. Both physician and patient receive the screening results before the visit.
  All patients and physicians are notified of the screening results before the patient leaves the clinic. All patients are offered supportive counseling.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of lung cancer
  -  Prescreening distress thermometer score > 3
  -  Zung Self-Rating Depression Scale (ZSDS) score ≥ 44
  -  No ZSDS response indicating suicidality
  PATIENT CHARACTERISTICS:
  -  Able to understand English
  -  No evidence of cognitive dysfunction that would impair giving consent
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: T-Cell Response in Patients Receiving Trastuzumab and/or Chemotherapy for HER2-Positive Solid Tumors

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. It may also help the study of cancer in the future.
  PURPOSE: This laboratory study is looking at blood samples from patients receiving trastuzumab and/or chemotherapy for HER2-positive solid tumors to assess T-cell response.

Detailed description: OBJECTIVES:
  -  Assess T-cell activation in blood samples of patients receiving trastuzumab (Herceptin®) and/or chemotherapy for HER2-positive solid tumors.
  OUTLINE: Blood samples are collected from patients at baseline and on days 21, 42, and 84 of trastuzumab (Herceptin®)/chemotherapy. Patients may be contacted 3-6 months after completion of trastuzumab/chemotherapy to donate another blood specimen.
  Blood samples are examined for T-cell proliferation and intracellular cytokine production. CD8 T-cell response, HER2/neu-specific antibody titers, and skin hypersensitivity test responses are also measured.
  PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of solid epithelial tumor, including, but not limited to, the following:
  -  Breast cancer
  -  Ovarian cancer
  -  Lung cancer
  -  Uterine cancer
  -  Prostate cancer
  -  HER2/neu-positive disease by immunohistochemistry or fluorescent in situ hybridization
  -  Must be receiving trastuzumab (Herceptin®) and/or chemotherapy (e.g., paclitaxel, docetaxel, fluorouracil, or estramustine)
  PATIENT CHARACTERISTICS:
  -  Absolute neutrophil count > 1,000/mm^3
  -  Absolute lymphocyte count > 400/mm^3
  -  Platelet count > 90,000/mm^3
  -  Hemoglobin > 8 g/dL
  PRIOR CONCURRENT THERAPY:
  -  No other chemotherapy within the past 4 weeks

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Glucose Metabolism in Patients With Non-Small Cell Lung Cancer Treated With Targeted Therapy and Chemotherapy

Summary: RATIONALE: Measuring changes in glucose metabolism in patients with cancer may help doctors predict how patients respond to treatment.
  PURPOSE: This clinical trial is studying glucose metabolism in patients with non-small cell lung cancer treated with targeted therapy and chemotherapy.

Detailed description: OBJECTIVES:
  -  Determine the prognostic significance of changes in glucose metabolism measured by fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scan in patients with non-small cell lung cancer treated with targeted drugs comprising gefitinib, erlotinib hydrochloride, or other ErbB inhibitors, cyclooxygenase-2 inhibitors, or estrogen receptor blockers in combination with conventional chemotherapy.
  OUTLINE: This is a prospective study.
  Patients undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET) scan and CT scan at baseline and at 2 weeks and 12 weeks after receiving targeted anticancer treatment. Metabolic changes detected by FDG-PET and size changes identified by CT scan are related to patient outcome and tumor response to treatment.
  PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed non-small cell lung cancer
  -  Any disease stage allowed
  -  Undergoing targeted treatment
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: DNA Analysis of Blood and Tissue From Patients With Lung Cancer

Summary: RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help the study of cancer in the future.
  PURPOSE: This clinical trial is analyzing the DNA in blood and tissue samples from patients with lung cancer.

Detailed description: OBJECTIVES:
  -  Assess the role of genetic polymorphisms in lung-cancer risk in patients with lung cancer.
  -  Assess the role of germline polymorphisms in DNA repair genes, p53 pathway genes, and a matrix metalloproteinase gene (tumor invasion factor) in lung-cancer risk, after adjusting for potential confounders.
  -  Assess the roles of gender and age in the genetic susceptibility of lung cancer.
  -  Assess the role of genetic polymorphisms in modifying the diet-lung cancer risk association (gene-diet and exploratory gene-gender-diet and gene-gene-diet interactions).
  -  Assess the role of polymorphisms on the risk of developing specific histologic subtypes of lung cancer in case-only analyses.
  -  Determine whether continued exposures to mainstream and/or second-hand tobacco smoking is associated with poorer clinical prognosis in patients treated for lung cancer.
  OUTLINE: This is a case-control study.
  Blood samples are collected from patients and controls. Samples are analyzed by polymerase chain reaction for gene polymorphisms. Genes to be studied include GSTP1, GSTM1, GSTT1, ERCC2, XRCC1, EPHX, NAT-2, p53 gene, CYP1A1, NQO1, MnSOD, and GPX1. Tissue samples collected from patients undergoing surgery and blood samples are archived for future studies.
  Patients and controls complete questionnaires about diet, medical history, and occupational/environmental history.
  PROJECTED ACCRUAL: A total of 3,400 patients and 3,400 controls will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Patient:
  -  Newly diagnosed lung cancer
  -  Patient at Massachusetts General Hospital (MGH) or Boston Medical Center Cancer Center
  -  Control:
  -  Nonblood-related friend or spouse of the patient
  -  No specific matching characteristics
  -  Friend or spouse of other hospital patients
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified
  EXCLUSIONS:
  Healthy controls with other primary cancers (melanoma, colon, etc.) are excluded Vulnerable populations are excluded

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Study of Anxiety and Avoidance of Others in Patients Previously Treated for Head and Neck Cancer

Summary: RATIONALE: Patients who undergo treatment for head and neck cancer may become anxious and avoid contact with other people. Learning how cancer treatment may cause anxiety in patients with head and neck cancer may help improve the quality of life in these patients.
  PURPOSE: This clinical trial is studying anxiety and avoidance of others in patients previously treated for head and neck cancer.

Detailed description: OBJECTIVES:
  -  Determine the relationship between treatment-provoked social anxiety and avoidance in patients previously treated for head and neck cancer.
  -  Determine the relationship between pre-cancer psychiatric diagnosis and post-treatment social anxiety and avoidance in these patients.
  -  Determine the effect of social anxiety and/or avoidance on the quality of life of these patients.
  -  Investigate the specificity of these relationships in patients with head and neck cancer by comparing patients with head and neck cancer to patients with lung cancer.
  OUTLINE: This is a cross-sectional study. Patients are stratified according to prior treatment type (significantly impairing [surgery] vs less impairing [chemotherapy/radiotherapy]).
  Patients undergo a face-to-face interview with a mental health clinician over 2 hours. Patients complete multiple psychiatric/psychological assessments during the interview, including the Structured Clinical Interview for DSM-IV (SCID); the Liebowitz Social Anxiety Scale (SAS); the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN); the Social Phobia and Anxiety Inventory (SPAI); the State-Trait Anxiety Inventory (STAI); Response to Stress Questionnaire, Cancer Version (RSQ-CV); the Functional Assessment of Cancer Therapy (FACT-HNC (head neck cancer) or LC); the Voice Handicap Index (VHI); and the Body Image Scale (BIS).
  Cancer treatment and medical history information are gathered from patients' medical records.

Eligibility: PATIENT CHARACTERISTICS:
  -  Diagnosis of 1 of the following:
  -  Head and neck cancer
  -  Lung cancer (control group)
  -  Must have received treatment for head and neck cancer or lung cancer within the past 5 years
  PATIENT CHARACTERISTICS:
  -  Able to speak and read English to answer surveys, interviews, and questionnaires
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant