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: Cetuximab as Therapy for Recurrent Non-Small Cell Lung Cancer Patients Who Have Received Prior Therapy

Summary: The purpose of this research study is to find out how well cetuximab works in treating NSCLC in patients who have been previously treated with a class of drug called tyrosine kinase inhibitor (TKI). Cetuximab is a protein that is designed to block a substance in cancer cells called "epidermal growth factor receptor" or EGFR. EGFR helps cancer cells grow.

Detailed description: -  Participants on this study will receive cetuximab by infusion intravenously once per week and may continue to receive weekly cetuximab infusions until their disease progresses or they experience unacceptable side effects.
  -  The following will be performed every 4 weeks while they are receiving study treatments: Physical examination; performance status; and blood work. A CT scan of the chest and upper abdomen will be performed every 8 weeks.

Eligibility: Inclusion Criteria:
  -  Pathologically confirmed stage IIIB or IV recurrent or progressive NSCLC
  -  Patients must have progressed while receiving treatment with a tyrosine kinase inhibitor targeting the EGFR pathway
  -  Measurable disease, as defined by RECIST criteria
  -  Patients must have a suitable frozen or paraffin-embedded tissue sample available for EGFR mutational analysis. Prior EGFR mutational analyses are allowable
  -  Patients with asymptomatic brain metastasis are eligible; however, they must have completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and be clinically stable
  -  ECOG Performance Status 0-2
  -  18 years of age or older
  -  Negative pregnancy test within 7 days of treatment or be categorized as not of child-bearing potential
  -  Bone marrow function, renal function, hepatic function as outlined in protocol
  Exclusion Criteria:
  -  Women who are pregnant of breastfeeding
  -  Active concurrent malignancy
  -  Major thoracic or abdominal surgery within 30 days prior to the first infusion of cetuximab
  -  Significant history of uncontrolled cardiac disease
  -  Uncontrolled seizure disorder, or active neurological disease
  -  Prior severe infusion reactions to a monoclonal antibody
  -  Prior chemotherapy regimen within 21 days prior to study entry
  -  Any EGFR tyrosine kinase inhibitor within 14 days of study entry
  -  Radiation therapy within 14 days prior to the first infusion of cetuximab
  -  Acute hepatitis or known HIV
  -  Active or uncontrolled infection
  -  Any concurrent chemotherapy or any other investigational agent(s)

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: Drug-Drug Interaction Study of TRK-100STP

Summary: The purpose of this study is to evaluate the effect of AST-120 on the PK of TRK-100STP, and to evaluate the safety and tolerability of TRK-100STP alone or in combination with AST-120

Detailed description: Non-blinded, randomized and crossover study to evaluate pharmacokinetic interaction between TRK-100STP and AST-120 in different administration condition. Nonelderly adult volunteers will receive TRK-100STP with or without AS-T120 after meal. Safety parameters will concurrently be measured.

Eligibility: Inclusion Criteria:
  -  Provision of written informed consent
  -  Body Mass Index (BMI) of ≥17.6 to ≤26.4 kg/m2 and weight of ≥50 to ≤80 kg
  Exclusion Criteria:
  -  Clinical abnormal physical findings, including BP, pulse rate, ECG and laboratory assessments
  -  Receives any investigational medicine within 120 days before screening
  -  Recent blood donor

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: Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD6918

Summary: The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD6918 based on the side effects experienced by patients with advanced solid malignancies that receive daily AZD6918 alone. It is possible that AZD6918 will be administered twice daily. Then maximum tolerated doses in combination with either gemcitabine or pemetrexed will also be investigated.


Eligibility: Inclusion Criteria:
  -  Advanced solid tumors for which standard treatment does not exist or is no longer effective.
  -  For chemotherapy combination treatment, must be suitable for treatment with either gemcitabine or pemetrexed.
  -  Relatively good overall health other than cancer.
  Exclusion Criteria:
  -  Poor bone marrow function (not producing enough blood cells).
  -  Poor liver or kidney function.
  -  Serious heart conditions
  -  History of uncontrolled epilepsy, Parkinson's disease, Alzheimer's disease, brain tumor or any uncontrolled psychiatric or nervous system condition

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: Vinorelbine/Gemcitabine Versus Vinorelbine/Carboplatin in Advanced Non-small Cell Lung Cancer

Summary: The purpose of this study is to explore if the combination of vinorelbine and gemcitabine is better than vinorelbine and carboplatin in the treatment of advanced non-small cell lung cancer, in terms of survival, quality of life and need for palliative radiotherapy.


Eligibility: Inclusion Criteria:
  -  Non-small cell lung cancer stage IIIB or IV
  -  Not eligible for radical radiotherapy or surgery
  -  WHO performance status 0-2
  Exclusion Criteria:
  -  Pregnancy
  -  Other clinical active cancer disease
  -  ALAT/ALP more than 3 times upper normal limit, bilirubin >1.5 upper limit
  -  Bowel disease that causes malabsorption

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: Imatinib + MTC in Relapsed / Refractory Acute Myeloid Leukemia (AML)

Summary: The purpose of this study is to show superiority in complete responses of combination therapy MTC plus Glivec in patients with refractory or relapsed AML compared to a historical control which was treated with MTC alone.


Eligibility: Inclusion Criteria:
  -  Refractory AML after primary therapy
  -  First relapse after a safe previous diagnosis of de novo or secondary AML
  -  Age > 18 years
  -  Serum bilirubin < 2.0 mg/dl
  -  Serum creatinine < 1.5 times the normal value or a creatinine clearance > 60 ml/min
  -  ECG and heart echography prior to start of therapy without severe findings
  -  Overall condition < 2 according to ECOG criteria
  -  Life expectancy > 6 weeks
  -  Written informed consent by patients with full legal capacity
  Exclusion Criteria:
  -  Serious secondary disease (clinically relevant cardiac disease, chronic- obstructive pulmonary disease, hepatic dysfunction, renal insufficiency)
  -  Active secondary neoplasia (exception: adequately treated basalioma or epidermoid cancer and cervical carcinoma)
  -  Known hypersensitivity to topoisomerase-I inhibitors
  -  Overall condition > 2 according to ECOG criteria
  -  Pregnant/breast feeding women
  -  Serious intercurrent infections

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: Airway Epithelium Gene Expression: AEGIS IDE

Summary: The purpose of the research study is to develop a new, more sensitive, and less invasive test for diagnosing lung cancer at an earlier stage, when it can more easily be cured. The investigators hypothesize that certain genes are expressed differently in current and former smokers who have lung cancer, and this difference in gene expression may be a biomarker for lung cancer.

Detailed description: Allegro Diagnostics is funding this multi-center study to validate and extend a new diagnostic tool measuring global gene expression in airway epithelial cells obtained at routine bronchoscopy in suspect lung cancer patients. The test, which is highly sensitive and specific for lung cancer, measures the levels of expression of genes in cells brushed from the large bronchi during diagnostic bronchoscopy. Similar brushings of epithelial cells from the nose will be analyzed to determine if gene expression in these cells can be used as a screening tool in subjects who may have now or be at risk for developing lung cancer in the future.

Eligibility: Inclusion Criteria:
  -  Patients being evaluated for the diagnosis of possible lung cancer or "rule out lung cancer" and undergoing clinically indicated bronchoscopy
  -  All patients are required to be at least 21 years of age and be able to understand and sign the informed consent form
  -  Patient must be a current or former cigarette smoker
  Exclusion Criteria:
  -  A pulmonary physician does not recommend that bronchoscopy be performed
  -  Inability to understand the written consent form and comply with requirements of the study
  -  History of prior primary lung cancer
  -  Immediately prior to bronchoscopy, the patient has been on a mechanical ventilator for >24 consecutive hours.

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: Retrospective Study Evaluating IGF1R And p95HER2 as Prognostic Factors in Non Small Cell Lung Cancer (NSCLC)

Summary: Aim of the study is to evaluated the role of IGF1R and p95HER2 on prognosis in radically resected non small cell lung cancer patients
  The primary objective is to correlate the expression of IGF1R and p95HER2 with survival.


Eligibility: Inclusion Criteria:
  -  Radically resected non small cell lung cancer patients with tumor tissue available
  Exclusion Criteria:
  -  Tumor tissue not available
  -  Clinical data not available

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: Medical Nutrition Therapy or Standard Care in Treating Patients With Lung Cancer, Pancreatic Cancer, or Stage III or Stage IV Prostate Cancer

Summary: This is a two-part study. Part I is an observational study. Part II is a randomized clinical trial to see how well medical nutrition therapy works compared with standard care in treating patients with lung cancer, pancreatic cancer, or stage III or stage IV prostate cancer.

Detailed description: In Part II of the study, patients are stratified according to tumor type (pancreatic vs lung vs prostate). Patients are then randomized to 1 of 2 arms.
  -  Arm I (Medical nutrition therapy): intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule.
  -  Arm II (standard care): Standard nutritional care includes the National Cancer Institute's booklet "Eating Hints for cancer patients: before, during & after treatment".
  In both arms, patients' weight, fat free mass, and Patient Generated Subjective Global Assessment Score (PG-SGA) score will be assessed before, during, and after the intervention. The PG-SGA includes a patient report of symptoms and a healthcare professional assessment of medical, metabolic, and physical parameters.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosed with one of the following:
  -  Pancreatic cancer
  -  Lung cancer
  -  Stage III or IV prostate cancer
  -  Undergoing treatment at The Cancer Institute of New Jersey
  -  Are undergoing chemotherapy (part 2 only)
  -  Has lost ≥ 5% of their usual body weight in the previous 6 months (part 2 only)
  PATIENT CHARACTERISTICS:
  -  Life expectancy > 60 days
  -  Must speak and read English
  -  Accessible in person or by phone for completing questionnaires
  -  Not pregnant or nursing
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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: D-Cycloserine Augmentation of Behavior Therapy for Individuals With Body Dysmorphic Disorder

Summary: The purpose of the study is to conduct a double-blind, placebo-controlled study of D-cycloserine (DCS) augmentation of behavior therapy in individuals with Body Dysmorphic Disorder (BDD). Specifically, we intend to randomize 50 individuals with BDD to receive either DCS (n = 25) or placebo (n = 25) one hour prior to 8 of 10 behavior therapy sessions.

Detailed description: This treatment study also provides us with the opportunity to further explore the molecular genetics of BDD, as well as the genetic predictors of response to an extinction-based treatment. We will take a hypothesis-driven approach by focusing on genes and systems previously shown to mediate fear acquisition and NMDA-dependent extinction learning including NMDA-related glutamatergic loci (GRIN1, GRIN2A, GRIN2B, DAAO, DAOA) and three other genes strongly implicated in fear extinction (BDNF, NTRK2, CNR1). Other loci of interest in the molecular genetics of BDD include: the serotonin transporter gene, dopamine, GABA-A, and cytochrome P450 genes.

Eligibility: Inclusion Criteria:
  -  18 years of age or older
  -  Primary diagnosis of Body Dysmorphic Disorder as determined by DSM-IV criteria
  -  BDD Yale-Brown Obsessive Compulsive Scale score greater than or equal to 24
  -  Females of childbearing potential must have a negative urinary beta-HCG test
  -  Subjects currently taking psychotropic medication must be on a stable does for at least two months prior to initiating study procedures
  Exclusion Criteria:
  -  Pregnant or breastfeeding women will be excluded
  -  People taking medications that may interfere with DCS
  -  History of seizure disorder or other serious medical illnesses such as cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
  -  Comorbid psychiatric diagnoses (alcohol dependence, bipolar disorder, psychosis, borderline personality disorder, organic mental disorder, or development disorder). If subjects have any other comorbid disorder, the BDD symptoms have to be the primary concern.
  -  Persons taking medications that may lower seizure threshold, including clozapine, pethidine, and the following antibiotics in high dosage: penicillins, cephalosporins, amphotericin, and imipenem
  -  Those deemed to pose a serious suicidal or homicidal threat will be excluded
  -  Current psychotherapy or failure to benefit from ten or more sessions of previous ERP treatment is a rule-out

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: Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

Summary: RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation therapy is more effective in treating patients with non-small cell lung cancer.
  PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with stage I or stage II non-small cell lung cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To compare the incidence of toxicity with two established stereotactic body radiotherapy (SBRT) regimens in patients with node-negative, peripheral stage I or II non-small cell lung cancer.
  Secondary
  -  To compare quality of life, patterns of failure, disease-free survival, and overall survival of these patients after treatment with one of two established SBRT regimens.
  -  To correlate outcomes and toxicities with imaging and patient and tumor biomarkers.
  OUTLINE: Patients are stratified according to Karnofsky performance status and treatment center. Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
  -  Arm II: Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
  Quality of life is assessed periodically by the EORTC QLQ-C30 and -LC13 questionnaires
  Blood and tissue samples may be collected periodically and examined for biomarkers via ELISA and immunoblotting.
  After completion of study treatment, patients are followed for 5 years.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed non-small cell lung cancer
  -  T1-T2, N0 disease measuring ≤ 5 cm( T3 tumor based on chest wall involvement is Excluded)
  -  Surgically resectable primary disease, however patient evaluated by thoracic oncologist and deemed medically inoperable OR patient refuses surgical resection
  -  Age >= 18
  Exclusion Criteria:
  -  Prior thoracic radiation therapy
  -  T2 or T3 tumor greater than 5 cm or T3 tumor based on chest wall involvement
  -  Node positive or metastatic disease
  -  Tumor location within the zone of the proximal bronchial tree. The proximal bronchial tree is defined as the carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, and right and left lower lobe bronchi. The zone of the proximal bronchial tree is defined as a volume 2cm in all directions around the proximal bronchial tree.
  -  No other conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy (e.g., unable to lie still and breathe reproducibly)
  -  Pregnant or unwilling to use adequate contraception

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: Tarceva And Radiotherapy in Locally Advanced Lung Cancer Non-small Cell Lung Cancer

Summary: The trial is a phase II study of daily Tarceva combined with definitive radiotherapy in inoperable locally advanced non small cell lung cancer (stage IIB-IIIB). The objective of the phase II trial is to examine Tarceva concomitant with curatively intended irradiation 66 Gy (2 Gy x 33 F, 5 F per week).


Eligibility: Inclusion Criteria:
  -  Age ≥18 years
  -  Patients with histologically or cytologically documented diagnosis locally advanced NSCLC stage IIB to IIIB without pleural effusion
  -  Performance status ≤2 on the ECOG scale
  -  Serum bilirubin must be ≤1.5 upper limit of normal (ULN)
  -  ALAT ≤2 x ULN
  -  Able to comply with study and follow-up procedures
  -  Patients with reproductive potential must use effective contraception
  -  Written (signed) informed consent to participate in the study
  Exclusion Criteria:
  -  Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease)
  -  Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
  -  Inability to take oral medication, or requirement of intravenous alimentation
  -  Nursing mothers

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: Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy

Summary: RATIONALE: Gathering information from patients who received treatment for metastatic cancer while participating in a phase II or phase III randomized clinical trial and from patients receiving standard treatment off-trial may help doctors learn more about the psychological and emotional results of being in a clinical trial.
  PURPOSE: This clinical trial is comparing the psychological and emotional impact of participating in a randomized clinical trial with the impact of standard treatment in patients with metastatic cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To compare the psychological and emotional consequences in patients who underwent first-line antitumor treatment (chemotherapy or targeted therapy) for metastatic disease while participating in a phase II or III randomized clinical trial vs patients who underwent standard first-line treatment off-trial.
  Secondary
  -  To measure and compare the temporal variation of psychological and emotional consequences during and after completion of or stopping of treatment.
  -  To measure and compare the degree of knowledge of the implications of participating in a clinical study vs the benefits of standard off-trial treatment and evaluate the impact on psychological and emotional experience.
  -  To evaluate the relationship between the use of adjustment strategies and emotional regulation and psychological and emotional experiences in both of these situations.
  OUTLINE: This is a multicenter study.
  Patients complete four questionnaires, including assessment of symptoms of anxiety and depression (HADS), quality of life (QLQ-30), adjustment strategies (WCC), and regulation of emotional behavior (ERQ), during their first course of treatment, after the first evaluation of treatment effectiveness, and one week after completion of treatment. During their first evaluation, patients also complete a questionnaire on the modalities of randomized clinical trials and their impact on care (ICEC-R).

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed cancer
  -  Metastatic disease for which the median progression-free survival is ≥ 4 months
  -  Breast, digestive, kidney, lung
  -  Receiving first-line antitumor therapy (i.e., chemotherapy or targeted therapy) as part of either:
  -  Phase II or III randomized clinical trial
  -  Standard treatment off-trial
  PATIENT CHARACTERISTICS:
  -  WHO performance status (PS) 0-3 or Karnofsky PS 50-100%
  -  No psychological or physical inability to respond to a questionnaire
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No psychotropic treatment, except for antidepressants, anxiolytics, or sleeping pills taken for more than 30 days

Relevance to patient case: not relevant