Kornimate/medical-research-clean huggingface dataset:
ebus tbna after pet/ct in diagnosing patients with stage i-iia non-small cell lung cancer evaluated for stereotactic body radiation therapy

Conditions: Lung Cancer

Summary: this clinical trial studies how well endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna) after positron emission tomography/computed tomography (pet/ct) scan works in diagnosing patients with stage i-iia non-small cell lung cancer evaluated for stereotactic body radiation therapy (sbrt). performing ebus-tbna after pet/ct scan may help doctors learn more about the accuracy and ways to find early stage lung cancer.

primary objectives: i. to assess the use of ebus-tbna after a pet/ct as a means of improving the accuracy of lymph node staging in patients considered for sbrt. secondary objectives: i. to assess the usefulness of pet/ct as a diagnostic test in identifying n1 versus n0 staging. ii. to compare survival and recurrence rates in patients with discordant pet/ct and ebus-tbna. iii. to describe ebus-tbna and sbrt related complications. outline: patients undergo ebus-tbna before sbrt. after completion of study, patients are followed up at 6 weeks, then every 3 months for the first 2 years then twice a year for the following 3 years, and annually thereafter.

Eligibility criteria:
inclusion criteria: 1. patient must be \> 18 years old 2. patient must have proven or suspected non small cell lung cancer (nsclc) and be clinical stage i or iia, according to the 7th edition staging system of the american joint commission on cancer for lung cancer (t1 or t2a, n0 or n1, m0) 3. patient must have a pet/ct obtained within 40 days of having the ebus-tbna 4. patient is being considered for sbrt 5. patient or the patient's legally authorized representative must provide written informed consent prior to registration and any study-related procedures 6. if the patient is a survivor of a prior invasive cancer, all of the following criteria must apply: a) patient has undergone potentially curative therapy for all prior malignancies b) no evidence of active / recurrent disease within 5 years exclusion criteria: 1. patient has received prior chemotherapy or radiotherapy for this cancer 2. patients already scheduled to receive conventional radiotherapy, chemotherapy, biological therapy, vaccine therapy, or surgery as treatment (except at disease progression) 3. patients malignancy is consistent with well differentiated neuroendocrine (carcinoid) histology 4. patients who are planning to undergo treatment in a different institution

Keywords: lung cancer non-small cell lung nsclc suspected non small cell lung cancer endobronchial ultrasound-guided transbronchial needle aspiration ebus-tbna
effect of 4 weeks of citrulline and glutathione supplementation on arterial function

Conditions: Menopause; Cardiovascular Risk Factor

Summary: examining the effects of 4 weeks of citrulline alone or in combination with glutathione on the arterial function of postmenopausal women.

l-citrulline is a non-protein amino acid and an efficient precursor of l-arginine, the substrate for endothelial nitric oxide synthesis. glutathione is a tripeptide with antioxidant effects. postmenopausal women will ingest 6g/d of l-citrulline or 2g of l-citrulline plus 200mg/d of glutathione or placebo (maltodextrin) for 4 weeks with vascular function testing prior to and after the intervention.

Eligibility criteria:
inclusion criteria: 1. generally healthy, postmenopausal women (defined as the absence of menstruation for at least 1 year). 2. between the ages of 50-79 years. 3. body mass index of 18.5 - 34.9 kg/m2. 4. brachial systolic blood pressure \< 150 mmhg, and diastolic blood pressure \< 90 mmhg. 5. sedentary (defined as \< 120 min/week of exercise). 6. be willing and able to comfortably abstain from any of food supplements for the period of time beginning 1 month prior to the study to the time of the termination of the study. 7. not participating as a subject in another study for at least 2 months prior to the study and for the duration of this study. exclusion criteria: 1. current or prior use of tobacco products, e-cigarettes or other inhaled substance. 2. use of medications and/or any supplements that may affect outcome variables (such as arginine-containing supplements, nitroglycerin, statin drugs, but not limited to those.) 3. taking hormone replacement therapy during the 3 months before the study. 4. more than a moderate intake of alcohol (\>7 drink per week). 5. cardiovascular diseases, diabetes and other metabolic or chronic diseases. 6. musculoskeletal disorders that will prevent exercise performance. 7. currently taking more than one vasoactive drug for blood pressure control. * subject having no more than one drug for prevention, which does not affect variables, may be included, but will be diagnosed as not having a disease.

Keywords: endothelial function aortic hemodynamics pressure wave reflection
gen-001 plus pembrolizumab for patients with advanced refractory biliary tract cancer

Conditions: Biliary Tract Cancer

Summary: this is a phase ii, multicenter, open-label study with a safety run-in to evaluate the safety and efficacy of gen-001 in combination with pembrolizumab or in combination with pembrolizumab and mfolfox for patients with advanced refractory btc who have progressed after 1 or 2 prior standard therapy and are not candidates for any other standard therapy. the safety run-in phase will be conducted before the main study phase


Eligibility criteria:
inclusion criteria: * the patient (or legally acceptable representative if applicable) provides written informed consent for the trial. * be ≥19 years of age on day of signing informed consent. * patient with histologically or cytologically confirmed diagnosis of unresectable, recurrent, or metastatic advanced biliary tract adenocarcinoma of the gallbladder or biliary tree (either intrahepatic or extrahepatic cholangiocarcinoma) exclusion criteria: * a wocbp who has a positive urine pregnancy test (within 72 hours) prior to treatment. if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. * has received prior therapy with an anti-pd-1, anti-pd-l1, or anti-pd-l2 agent or with an agent directed to another stimulatory or co-inhibitory t-cell receptor (cohort 1 only), and was discontinued from the previous io therapy due to a grade 3 or higher immune-related ae (irae) (cohort 2 and cohort 3). * is currently participating and receiving study treatments or has participated in a study of an investigational agent and received the study therapy or has used an investigational device within 4 weeks prior to the first dose of study treatment. * has had an allogeneic tissue/solid organ transplan
intra- and interrater reliability of quantitative ultrasound assessment of gastric content in term parturients before elective caesarean delivery

Conditions: Pregnancy; Respiratory Aspiration of Gastric Content

Summary: the presence of solid food or fluid residue in the stomach is always a major concern when patients require medical procedures under sedation or general anesthesia, due to the high risk of pulmonary aspiration of the stomach contents. this is especially important in emergency procedures, when a fasting period could not be observed. pulmonary aspiration of gastric content is a serious perioperative complication of obstetric anesthesia, and it is associated with morbidity and mortality. information from a bedside ultrasound assessment of the stomach may be a very useful resource to decide whether it's safe to proceed, cancel or delay a surgical procedure. the ultrasound assessment of the stomach content has shown to be very feasible and practical in non-pregnant patients. however, it has not been determined whether the competence reached by anesthesiologists in non-pregnant subjects can be transferred to the obstetric population, especially in term pregnant patients where it could be difficult to identify the stomach because of the presence of the gravid uterus. although quantitative assessment of the gastric antrum cross-sectional area in terms of intra- and interrater reliability has been evaluated in non-pregnant adults, it remains to be evaluated in pregnant patients. furthermore, it has not been determined whether the performance of novice operators is comparable to expert operators in the gastric quantitative assessment. this study aims to determine whether trained anesthesiologists can reliably assess the stomach content of pregnant patients by ultrasound, evaluating the inter- and intra-rater reliability of quantitative gastric ultrasound in term pregnant patients comparing anesthesiologists of different level of expertise. the investigators hypothesize a substantial to almost perfect agreement in the intra- and interrater reliability of the antral cross-sectional area among raters in term pregnant patients scheduled for elective cesarean delivery.


Eligibility criteria:
inclusion criteria: * non-laboring term pregnant women scheduled for cesarean delivery under neuraxial anesthesia * ≥37 weeks gestational age * ≥18 years of age * asa physical status ii-iii * weight 50 to 120 kg * height ≥150 cm * ability to understand the rationale of the study evaluations. exclusion criteria: * multiple pregnancy * known (reported by the study subject) anomalous anatomy of the upper gastrointestinal tract * previous surgical procedures on the esophagus, stomach or upper abdomen * patients not following our institutional fasting instructions (8 hours after a meal and 2 hours for clear liquids)

Keywords: gastric ultrasound
breast cancer trials education program

Conditions: Breast Cancer

Summary: the purpose of this study is to test a program designed to increase african american and hispanic american women's scientific literacy, knowledge of clinical trials, and to facilitate breast cancer clinical trial participation.

knowledge and participation in clinical trials is disproportionately low among minorities. the purpose of this study is to test a program designed to increase african american and hispanic american women's scientific literacy, knowledge of clinical trials, and to facilitate breast cancer clinical trial participation. a validation study was also conducted to validate several measures for the hispanic american and african american populations. the experimental group watched an education program concerning breast cancer clinical trials while the control group watched an education program on neighborhood safety. to examine willingness to participate in research was assessed by a post-intervention invitation to complete a sleep diary.

Eligibility criteria:
inclusion criteria: * self-identified as an african american or a hispanic american female * speak english and/or spanish * mentally and physically capable of completing the consenting process exclusion criteria: * none

Keywords: clinical trials education hispanic americans african americans health disparities patient participation refusal to participate
resist: understanding the role of depression in heart disease

Conditions: Depression

Summary: this study will investigate the biological pathways involved in anti-depressant resistance that increase risk of cardiovascular disease in people with depression.

rationale: depression is known to be associated with the development of cardiovascular disease and poorer prognosis after cardiac events, however the mechanisms that mediate these links are poorly understood. inflammatory and neuroendocrine processes are thought to play an important role in this relationship. in addition, antidepressants have been shown to improve cardiac outcomes and have anti-inflammatory effects, whilst inflammation has been shown to be elevated in patients who do not respond to treatment. several possible biomarkers for antidepressant resistance have also been demonstrated to be cardiovascular risk markers. these include acute phase inflammatory markers, such as interleukin-6 (il-6), and hypothalamic-pituitary-adrenal axis (hpa) dysregulation. design: this will be conducted alongside a larger pharmacological trial, panda, where participants will be recruited from primary care and randomized to sertraline (ssri) or placebo. the resist study will compare inflammatory cardiovascular risk factors between depressed patients taking sertraline, depressed patients taking placebo and healthy controls. this will be achieved by investigating the pharmacological effect of antidepressants on gene expression, glucocorticoid and mineralocorticoid receptor function and regulatory t cell (treg) profiles.

Eligibility criteria:
inclusion criteria: * depressed patients: * meet icd10 criteria from the clinical interview schedule-revised (cis-r) exclusion criteria: * depressed patients: * are taking any anti-inflammatory drugs or drugs which interfere with hpa-axis function, endothelial function, circadian rhythm or any other pathways under investigation * unable to read, understand and/or complete questionnaires * other psychiatric disorders: psychosis, schizophrenia, bipolar disorder, mania, hypomania, dementia, and eating disorder * vulnerable adults * healthy controls: * have a history of depression * are taking any anti-inflammatory drugs or drugs which interfere with hpa-axis function, endothelial function or circadian rhythm or any other pathways under investigation * unable to read, understand and/or complete questionnaires * other psychiatric disorders: psychosis, schizophrenia, bipolar disorder, mania, hypomania, dementia, and eating disorder * vulnerable adults
the efficacy of potassium-competitive acid blocker in patients with laryngopharyngeal reflux disease

Conditions: Laryngopharyngeal Reflux Disease

Summary: background/aims: tegoprazan is a novel potassium-competitive acid blocker that has a fast onset of action and can control gastric ph for a prolonged period, which could offer clinical benefit in acid-related disorders. the investigators aimed to evaluate whether tegoprazan would be more effective in controlling symptoms than placebo in patients with laryngopharyngeal reflux disease (lprd). methods: this double-blind, randomized, placebo-controlled trial randomly assigned 35 patients suffering lprd symptom to two groups: tegoprazan50mg once daily and placebo. the primary end point was complete resolution rate of lprd symptoms after 8-week medication, and the secondary endpoints were complete resolution rate of lprd symptoms after 4-week medication, change of reflux symptom index (rsi) and reflux finding score (rfs) from baseline at 4- and 8-week medication.


Eligibility criteria:
inclusion criteria: * at least one symptom of lprd (hoarseness, globus, persistent throat discomfort, and frequent throat clearing) for at least 4 weeks * reflux symptom index \> 13 and reflux finding score ≥ 7 exclusion criteria: * viral or bacterial laryngopharyngitis at present * history of malignancy of head and neck region, esophagus and stomach * previous radiotherapy or endotracheal intubation within three months * previous anti-reflux surgery or gastroesophageal surgery * diagnosis of depression, anxiety, panic, somatoform or other psychotic disorder * taking anti-psychotics, anti-depressants or anti-anxiety drugs * anti-reflux medication such as proton-pump inhibitors (within 4 weeks before screening), histamine receptor 2 blockers, antacids or prokinetics (within 2 weeks before screening) * need for continuous therapy with non-steroidal anti-inflammatory drugs * pregnant or breastfeeding women, as well as female patients who were not willing to use contraception for the duration of the clinical trial period * abnormal laboratory test values at screening (blood urea nitrogen and serum creatine level \>1.5 upper limit of normal \[uln\]; total bilirubin levels and serum levels of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and gamma-glutamyl transferase \> 2 uln) or * any other conditions or disease that an investigator considered not appropriate for this study

Keywords: : laryngopharyngeal reflux disease potassium-competitive acid blocker treatment effectiveness
a phase 3 extension study of rad011 (cannabidiol oral solution) in patients with prader-willi syndrome

Conditions: Prader-Willi Syndrome

Summary: this is a phase 3 open-label extension (ole) study in patients diagnosed with prader-willi syndrome (pws) who completed the maintenance period of the randomized, placebo-controlled phase 2/3 study scout-015. the primary objective of this study is to assess the long-term safety and tolerability of rad011.


Eligibility criteria:
inclusion criteria: * presence of a parent/legal guardian that is able to consent for their participation. parent/caregiver/legal guardian can complete the required assessments throughout the study. patient consent/assent will be obtained if the patient is 8 years of age or older and has the mental capacity to understand and sign a written consent/assent form and/or give verbal assent; * patient completed treatment on the scout-015 study through visit 14 (week 34); * if female, is either not of childbearing potential (defined as premenarchal or surgically sterile \[bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\]) or practicing one of the following medically acceptable methods of birth control up to 4 weeks after the last dose of rad011 or placebo: exclusion criteria: * significant acute condition (active infection, uncontrolled diabetes, any other uncontrolled chronic condition) including but not limited to clinically significant laboratory abnormality, or medical or psychosocial condition that may preclude the patient from participating in the study, at the investigator's discretion; * positive urine test for drugs of abuse, including tetrahydrocannabinol (thc), or known history of drug, alcohol, or substance abuse; * significant risk of committing suicide based on history, psychiatric examination, or based on the investigator's judgment; * significant non-compliance issues (ip misuse or abuse, study visit participation, etc.) during the patient's scout-015 participation based on the investigator's judgement. * pregnant (determined by a positive urine pregnancy test) or lactating female; * concurrent participation in any other interventional study involving an investigational product, gene therapy, or device.
response evaluation in malignant pleural mesothelioma

Conditions: Malignant Pleural Mesothelioma

Summary: recently, a few small trials have shown promising results on value of fluoro-2-deoxy-d-glucose and positron emission tomography imaging in response assessment in malignant pleural mesothelioma. these studies considered different parameters in positron emission tomography (pet) analysis, mainly the standardized uptake value and volume-based parameters such as total glycolytic volume.

this is a retrospective analysis of two consecutive and homogeneous series of malignant pleural mesothelioma patients treated with first-line pemetrexed-based chemotherapy and evaluated by ct scan and fdg-pet.

Eligibility criteria:
inclusion criteria: * histologically proven malignant pleural mesothelioma * patients not candidate to radical surgery * unidimensionally and/or bidimensionally ct-measurable disease and candidate to first-line pemetrexed-based chemotherapy exclusion criteria: * histologically not proven malignant pleural mesothelioma

Keywords: histologically proven of malignant pleural mesothelioma; patients not candidate to radical surgery; candidate to first-line pemetrexed-based chemotherapy;
immediate loading of bone anchored hearing devices

Conditions: Hearing Loss

Summary: bone anchored hearing aids provide a hearing solution for patients that are unable to wear traditional air conduction hearing aid solutions. the technology of the devices has developed significantly over the last 510 years and patients are gaining access to their sound processor at a much earlier stage than when first brought onto the market. despite this the investigators feel there is still room to develop this and with the new abutments with specialised hydroxyapatite coating it is hoped that patients can be loaded with their sound processor in the day of surgery. this study will compare abutment stability between two groups of patients. those loaded immediately with their sound processor and those loaded traditionally at 2 weeks post operatively. at routine followup appointments patients will have the stability of their abutment checked and the investigators will compare to see if loading earlier had any detrimental effects on osteointegration and the stability of the abutment. based on the favourable outcomes and high stability record for the ba400 it is anticipated that the time to processor fitting may be further reduced, provided favourable bone conditions at the implant site and provided satisfactory soft tissue status at the time of loading. it is hypothesised that loading immediately at the time of surgery is possible with comparable short and long term outcomes when compared to standard loading at 2 weeks


Eligibility criteria:
inclusion criteria: * patients eligible for receiving the baha system. exclusion criteria: * adult patients, i.e. ≥18 years * eligible for the baha system * bone thickness at the implant site of at least 4 mm * no known disease or treatment that compromises / will compromise the bone quality at the implant site
longitudinal outcomes in hepatic resection

Conditions: Liver Diseases; Surgery

Summary: this observational registry of patients undergoing liver surgery collects patients both retrospectively and prospectively. patients undergoing liver resection for any non-transplant indication will be evaluated for clinical outcomes (such as surgical complications, survival, and disease progression) based on clinical and patient factors (like indication, age, and other treatments for the disease).


Eligibility criteria:
inclusion criteria: * patients requiring liver resection exclusion criteria: * patients under the age of 18 years * patients undergoing liver transplant

Keywords: hepatectomy