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: Oral Contraceptive Ethinyl Estradiol Dose Effect on Postpartum Depression and Sexual Functioning Scales

Summary: This is a prospective, randomized, controlled cohort study. This study will look at the effect of Ethinyl Estradiol 35mcg/Norethindrone 1mg and Ethinyl Estradiol 20 mcg/Norethindrone 1mg on postpartum depressive symptoms and sexual function scores when compared to a control group using no hormonal contraception. Depressive symptoms and sexual function will be measured using the Edinburgh Postnatal Depression Scale (EPDS), Arizona Sexual Experiences Scale (ASEX), and Brief Index of Sexual Functioning for Women (BISF-W). Participants will begin taking the medication at Week 3 postpartum, and these outcomes will be measured at baseline (0-1 day postpartum), Week 3, and Week 6-7. The investigators hypothesize that there will be an ethinyl estradiol dose related response in EPDS, ASEX, and BISF-W scores at Week 6-7, which would indicate a decrease in depressive symptoms and increase in sexual function in both of the oral contraceptive groups.


Eligibility: Inclusion Criteria:
  -  18-45 year old women who desire contraception postpartum for at least 6 weeks.
  -  18-45 year old women who choose not to use oral contraceptive medication postpartum for at least 6 weeks for the control group.
  Exclusion Criteria (Medication groups):
  -  Breastfeeding (although this may limit participant enrollment, combined oral contraceptives are contraindicated in this population).
  -  Delivery by cesarean section.
  -  Previous history of depression, mood disorders, or psychiatric disorders.
  -  Any condition (history or presence of) which contraindicates the use of combination OCs, including:
  -  Thrombophlebitis or thromboembolic disorders, known or suspected clotting disorders, deep vein thrombosis, thrombogenic valvulopathies or rhythm disorders.
  -  Pulmonary Embolism.
  -  Cerebrovascular or coronary artery disease or myocardial infarction.
  -  Diabetes mellitus.
  -  Migraine headaches with focal, neurological symptoms.
  -  Chronic renal disease.
  -  Uncontrolled or untreated hypertension.
  -  Cholestatic jaundice.
  -  Known or suspected carcinoma of the breast, endometrial carcinoma, or known or suspected estrogen-dependent neoplasia.
  -  Impaired liver function or disease, hepatic adenomas or carcinomas.
  -  Known hypersensitivity to estrogens and/or progestins.
  -  History of thyroid disorders.
  -  Recent alcohol or drug use.
  -  Smoking and age ≥35 or smokers who will become 35 years of age during the study.
  -  Known history of noncompliance with taking medication.
  Exclusion Criteria (Control group):
  -  Previous history of depression, mood disorders, or psychiatric disorders.
  -  Recent alcohol or drug use.

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 1/1b Study of MGCD516 in Patients With Advanced Cancer

Summary: MGCD516 is a receptor tyrosine kinase (RTK) inhibitor shown in preclinical models to inhibit a closely related spectrum of RTKs including MET, AXL, MER, and members of the VEGFR, PDGFR, DDR2, TRK and Eph families. In this study, MGCD516 is orally administered to patients with advanced solid tumor malignancies to evaluate its safety, pharmacokinetic, metabolism, pharmacodynamic and clinical activity profiles.
  During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed; during the Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient populations.
  Patients anticipated to be enrolled in Phase 1b will be selected based upon having a tumor type, including but not limited to, non small cell lung cancer and head and neck cancer positive for specific activating MET, NTRK2, NTRK3, or DDR2 mutations, MET or KIT/PDGFRA/KDR gene amplification, selected gene rearrangements involving the MET, RET, AXL, NTRK1, or NTRK3 gene loci, or having loss of function mutations in the CBL gene. In addition patients with clear cell renal cell carcinoma refractory to angiogenesis inhibitors or metastatic prostate cancer with bone metastasis will be enrolled.

Detailed description: During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed.
  During the Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient populations. Patients anticipated to be enrolled in Phase 1b will be selected based upon the following cancer diagnosis:
  Non-small cell lung cancer with genetic alterations in MET, AXL, RET, TRK, DDR2, KDR, PDGFRA, KIT or CBL.
  Head and neck squamous cell carcinoma with genetic alterations in MET.
  Clear cell renal cell carcinoma refractory to angiogenesis inhibitors.
  Metastatic prostate cancer with bone metastases.
  Other cancer diagnosis having a selected genetic alteration in MGCD516 target RTKs.

Eligibility: Inclusion Criteria:
  -  Metastatic or unresectable solid tumor malignancy
  -  Standard treatment is not available
  -  Adequate bone marrow and organ function
  Exclusion Criteria:
  -  History of a significant cardiovascular illness
  -  Prolonged corrected QT (QTc) interval
  -  Left ventricular ejection fraction < 40%
  -  Symptomatic or uncontrolled brain metastases
  -  Other active cancer

Relevance to patient case: possibly relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: A Study of DCC-2701 in Participants With Advanced Solid Tumors

Summary: The main purpose of this study is to investigate the safety of the investigational drug DCC-2701 and whether it will work to help people who have advanced solid tumors or cancer that has spread to other parts of the body.

Detailed description: This is a first-in-human study of DCC-2701. The primary purpose of this study is to determine what dose of DCC-2701, can be given safely to patients with advanced solid tumors.
  The study will have two phases. The first phase will assess escalating doses of DCC-2701 in order to determine the maximally tolerated dose (MTD) and the optimal dosing regimen (ODR) of DCC-2701. Once the MTD and ODR is established, a dose expansion phase will further evaluate the safety of DCC-2701, as well as the activity of DCC-2701 in select solid tumor types.

Eligibility: Inclusion Criteria:
  -  Advanced or metastatic solid tumor that has progressed or was not responsive to standard therapy
  -  The cancer has no proven effective therapy
  -  The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required)
  -  Able to swallow tablets
  Exclusion Criteria:
  -  Have active central nervous system (CNS) metastasis
  -  Have an active infection of any kind (fungal, viral, or bacterial)
  -  Are pregnant or breastfeeding

Relevance to patient case: possibly relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Longitudinal Metabolomic and Epigenetic Profiling of Bodyfluids From Patients With Lung and Brain Cancer Receiving Radiation Therapy

Summary: This research trial studies metabolomic and other molecular profiling to identify predictive biomarkers for radiation toxicity and survival in patients with lung or brain cancers receiving radiation therapy. Studying samples of blood, urine, and tissue from patients with lung or brain cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer and predict which patients are at higher risk for developing radiation side effects and how well patients will respond to radiation treatment.

Detailed description: PRIMARY OBJECTIVES:
  I. Metabolomic and epigenetic urine and blood profiles of patients undergoing radiation therapy for lung cancer associated with the development of radiation pneumonitis.
  II. Metabolomic and epigenetic urine and blood profiles of patients undergoing radiation therapy for brain cancer associated with the development of radiation necrosis.
  SECONDARY OBJECTIVES:
  I. Metabolomic and epigenetic urine, blood, and tissue profiles of patients undergoing radiation therapy for lung and brain cancer associated with survival.
  OUTLINE:
  Collected blood, urine, and tissue samples are analyzed for biomarkers via metabolomic and epigenetic profiling using massspectrometry, array, and sequencing-based technology.

Eligibility: Inclusion Criteria:
  -  Consultation with the Radiation Oncology department of the Ohio State University (OSU) Comprehensive Cancer Center
  -  The following diagnoses will be included: malignant neoplasm of the brain; primary malignant neoplasm of trachea bronchus and lung; primary malignant neoplasm of the cervix uteri and primary malignant neoplasm the prostate
  Exclusion Criteria:
  -  Being an inmate

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: NGS Genome Analysis in Personalisation of Lung Cancer Treatment

Summary: The identification of driver mutations in the epidermal growth factor receptor (EGFR) as the primary oncogenic event in a subset of lung adenocarcinomas led to a model of targeted treatment and genetic profiling of the disease. EGFR tyrosine kinase inhibitors (TKIs) confer remission in some patients, but use of the EGFR-TKIs is limited to patients with adenocarcinomas who have known activating EGFR mutations. And resistance to TKI treatment has become an increasingly important cause of treatment failure. Therefore, identification of the molecular components involved could lead to the development of effective therapy. Today only a limited number of genetic alterations are studied.
  Next Generation Sequencing (NGS) has the potential of becoming an important tool in clinical and therapeutic decision-making in oncology owing to its enhanced sensitivity in DND mutation detection.


Eligibility: Inclusion Criteria:
  -  patients of bronchial adénocarcinoma with metastases can benefit from first-line therapy - targeted therapy by tyrosine kinase inhibitor(TKI) for EGFR mutation and chemotherapy for non EGFR mutation)
  -  Patients with epidermoid cancer of the lungs can benefit from chemotherapy
  -  man and women
  -  age ≥ 18 years
  -  Patients have signed a written informed consent form
  -  Patients are affiliated to s social health insurance
  Exclusion Criteria:
  -  Survival time ≤ 3 months
  -  Patients with cerebral metastases
  -  Patients could not benefit from treatment for others diseases
  -  Pregnancy or breast-feeding
  -  Incapacity to sign the consent form for psychiatric, behavioural disorders
  -  Private individuals of freedom or under tutelage

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: PCORI-CER-1306-03385 Lung Cancer Screening Readiness Study

Summary: Investigators will administer a brief, anonymous survey at the Texas Academy of Family Physicians (TAFP) annual Primary Care Summit to better understand the readiness of primary care physicians in Texas to implement lung cancer screening programs in their practice settings.

Detailed description: For this project there will be up to 1000 participants. Physicians attending the annual CME event at the Texas Academy of Family Physicians event will be asked to fill out an anonymous survey to better understand their readiness to implement lung cancer screening programs in their practice settings. The surveys will be administered to physicians attending the TAFP education events in Houston, Texas, October 17-19, 2014 and in Dallas, Texas, November 7-9, 2014.

Eligibility: Inclusion Criteria:
  1. Physicians attending the TAFP education events in Houston, Texas, October 17-19, 2014 and in Dallas, Texas, November 7-9, 2014.
  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: Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken With a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC)

Summary: A Phase I study to assess the systemic exposure, effiacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC)


Eligibility: Inclusion:
  1. Histologically or cytologically confirmed diagnosis of stage IIIB (and is not a candidate for definitive multimodality therapy) or IV ALK-positive NSCLC.
  2. Patients may have received one prior treatment regimen with crizotinib (all other ALK inhibitors are excluded).
  3. Patients may have received prior chemotherapy, biologic therapy, or other investigational agents. ALK inhibitors other than crizotinib are excluded.
  4. Patient has a World Health Organization (WHO) performance status 0-2.
  Exclusion:
  1. Prior treatment with an ALK inhibitor other than crizotinib.
  2. History of carcinomatous meningitis.
  3. Presence or history of a malignant disease other than an ALK-positive advanced tumor that has been diagnosed and/or required therapy within the past 3 years.
  5. Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months) 6. Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).
  7. Patient has other severe, acute, or chronic medical conditions 8. Patient is currently receiving treatment with warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants.

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: Follow-up Study of Complications of Acute Pancreatitis

Summary: This is a follow-up study focusing on long-term complications of acute pancreatitis. The primary purposes include: 1. To assess the incidence of type 2 diabetes mellitus（2-DM）,impaired glucose tolerance, metabolic abnormalities of blood lipids after acute pancreatitis. 2. To observe the possible long-term clinical outcomes after acute pancreatitis attack, which may include: chronic pancreatitis, pancreatic cancer, pancreatogenic portal hypertension, autoimmune pancreatitis et al. 3. To evaluate the long-term influence of acute lung injury(PaO2/FiO2<200,FiO2 means fraction of inspiration O2) in AP patients during ICU stay on life qualities of the patients; 4. To observe the prognosis of the local complications of acute pancreatitis(AP) patients; it might be helpful to find the most effective and targeted interventions aiming at different phases after AP attack.

Detailed description: Currently，follow-up study is limited on glucose intolerance and life quality assessment. However, it has been shown that AP is associated to some extent with other diseases such as chronic pancreatitis, pancreatic cancer, pancreatogenic portal hypertension and autoimmune pancreatitis; In addition, for patients who have severe lung injury following AP, especially with PaO2/FiO2<200 during ICU stay, the long term prognosis remains unclear. Thus, a large sample follow-up study is essential for elucidating the possible long-term complications.
  Prior to follow up study, the investigators performed baseline analysis of AP patient data from the database of the First Affiliated Hospital of Nanchang University. It is estimated that 1300 patients will be interviewed over telephone and 600 patients in the outpatient department. The content of the follow-up includes: questionnaire (the MOS[medical outcome study] item short from health survey, SF[short form]-36) ; lab testing(complete blood count, blood chemistry such as liver and kidney function, C-reaction protein(CRP), AMY, fasting blood-glucose，1 and 2 hour postprandial blood glucose,C-peptide, blood lipids, FE-1) and CT scan. For patients who have severe lung injuries during ICU stay, pulmonary function test, Blood gas analysis and chest CT will be performed. After screening, the patients with chronic pancreatitis(CP), pancreatic cancer(PC), post Pancreatogenic portal hypertension（PPH） or autoimmune pancreatitis(AIP）will be hospitalized for further therapy.

Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of acute pancreatitis from our hospital
  -  Must be signed the informed consent
  Exclusion Criteria:
  -  Failed to complete the questionnaire survey and the follow-up examination

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: An epidemiOlogy Study to deteRmine the Prevalence of EGFR (Epidermal Growth Factor Receptor) muTations in RUSsian Patients With Advanced NSCLC (Non-Small Cell Lung Cancer).

Summary: This is a multicentre, non-interventional, prospective study to be carried out in representative oncology departments / institutions in order to determine the prevalence of EGFR mutations in treatment-naive Russian patients with cytologically verified advanced NSCLC in Russia.

Detailed description: This is a multicentre, non-interventional, prospective study to be carried out in representative oncology departments / institutions in order to determine the prevalence of EGFR mutations in treatment-naive Russian patients with cytologically verified advanced NSCLC in Russia. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.
  It is planned to enrol approximately 300 subjects in Russian Federation. Approximately 60 EGFR m+ (mutation-positive) patients will be followed for 1.5 years.
  EGFR mutations rate before treatment in cytology and plasma samples in treatment-naive patients with advanced NSCLC in Russia is considered as the primary outcome variable in this study.

Eligibility: Inclusion Criteria:
  -  Cytologically verified advanced (stages IIIB - IV) nonsquamous (adenocarcinoma, large cell carcinoma) and mixed subtypes of NSCLC and NSCLC-NOS), diagnosed before enrolment into the study
  -  Quality and quantity of the cytological sample material meeting the requirements of the molecular-genetic testing
  -  No previous/ ongoing treatment for NSCLC at the moment of recruitment
  Exclusion Criteria:
  -  Squamous NSCLC cytologically confirmed subtype of cancer
  -  Any medical condition which on the opinion of the investigator may interfere the patient's participation in the study
  -  Quality and quantity of the cytological sample material insufficient for the molecular-genetic testing

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: Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer

Summary: 300 patients with colorectal cancer will be investigated before surgery and 60 of them will also be investigated in the same manner after surgery. Investigations will include polysomonographic sleep apnea recordings during one night, lung function measurements, blood gas samples and a questionnaire, but only before surgery including questions on sleep, sleep apnea, lung disorders.
  Outcome: side effects of surgery and mortality rate, association with cancer type.
  Prevalence of sleep apnea, sleep quality, hypoxemia and lung function before and after surgery.

Detailed description: Group 1. Inclusion: 240 patients with colorectal cancer scheduled for surgery. Exclusion: Dementia, CPAP treated sleep apnea Methods: Patients are investigaged before surgery with Lung-function measurements, blood-gas sample, questionnaire, Overnight polysomnographic sleep apena recordings including oro-nasal airflow, thoraco-abdominal respiration belts, chin-EMG, EOG, EEG, ECG (V5) and body position.
  Outcome variables: complications of surgery including anastomosis insuficiency and wound infections. Short and long term mortality, Sleep apnea, hypxoia, hyprecapnia and effect on lungfunction (VC, FEV1). Detailed morphologic analysis of cancer type.
  Group 2. Inclusion: 35 patients with colorectal cancer scheduled for open surgery, Exclusion: Dementia, CPAP treated sleep apnea Methods: Patients are investigaged before and 2 days after surgery with Lung-function measurements, blood-gas sample, questionnaire (only before surgery), Overnight polysomnographic sleep apena recordings including oro-nasal airflow, thoraco-abdominal respiration belts, chin-EMG, EOG, EEG, ECG (V5) and body position.
  Outcome variables: Effect on sleep apnea, sleep parameters, blood-gas and lungfunction before and after surgery. Complications of surgery including anastomosis insuficiency and wound infections. Short and long term mortality. Detailed morphologic analysis of cancer type.
  Group 3. Inclusion: 25 patients with colorectal cancer scheduled for laparoscopic or robot surgery.
  Exclusion: Dementia, CPAP treated sleep apnea Methods: Patients are investigaged before and 2 days after surgery with Lung-function measurements, blood-gas sample, questionnaire (only before surgery), Overnight polysomnographic sleep apena recordings including oro-nasal airflow, thoraco-abdominal respiration belts, chin-EMG, EOG, EEG, ECG (V5) and body position.
  Outcome variables: Effect on sleep apnea, sleep parameters, blood-gas and lungfunction before and after surgery. Complications of surgery including anastomosis insuficiency and wound infections. Short and long term mortality. Detailed morphologic analysis of cancer type.

Eligibility: Inclusion Criteria:
  -  Patients scheduled for surgery of colorectal cancer
  Exclusion Criteria:
  -  Dementia, CPAP treatment for obstructive sleep apnea

Relevance to patient case: not relevant