Kornimate/medical-research-clean huggingface dataset:
retrospective chart review and historical comparison of capmatinib vs. standard of care for german adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) harboring metex14 mutations

Conditions: Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring METex14 Mutations

Summary: the objective of the study was to compare the therapeutic benefit of capmatinib versus appropriate comparative therapy (act) defined by the german hta agency g-ba for its benefit assessment of capmatinib but also versus the standard of care (soc) practiced in german routine care. due to its design as an adjusted, patient-level comparison, the recap study addresses the evidence gap due to the single-arm nature of pivotal evidence for capmatinib. for this purpose, data on patients treated with act resp. soc in german routine care has been collected via a retrospective chart review. this data was then used as an external control for a non-randomized, patient-level adjusted comparison with data from the geometry mono-1 study of capmatinib (nct02414139). due to the non-interventional nature of this study, the definition of endpoints as primary or secondary was omitted formally.


Eligibility criteria:
inclusion criteria * nsclc (any histology) * metex14 mutation * epidermal growth factor receptor (egfr) wildtype * anaplastic lymphoma kinase (alk) rearrangement negative * stage iv or stage iiib without indication for local therapy * first or second line of treatment * age ≥18 years exclusion criteria * prior treatment with crizotinib, capmatinib, tepotinib or other met inhibitors * carcinomatous meningitis * symptomatic brain metastases * eastern cooperative oncology group status (ecog) \>1 * uncontrolled, clinically significant heart diseases * malignant disease other than nsclc within the past 3 years
benazepril for advanced chronic renal insufficiency

Conditions: Chronic Kidney Failure

Summary: the purpose of this study is to further determine whether benazepril, could safely slow the progression of renal dysfunction in non-diabetic patients with advanced renal insufficiency.


Eligibility criteria:
inclusion criteria: 1. serum creatinine concentration 1.5-5.0 mg/dl (133-442 µmol/l) 2. creatinine clearance 20 to70 ml/min/1.73 m2, with variations of less than 30 percent in the three months before the screening evaluation 3. non-diabetic renal disease 4. persistent proteinuria (defined as urinary protein excretion greater than 0.3 g/day for three or more months without evidence of urinary-tract infection or overt heart failure \[new york heart association class iii-iv\]). exclusion criteria: * immediate need for dialysis; treatment with corticosteroids, non-steroidal anti-inflammatory drugs or immunosuppressive drugs; renovascular disease; myocardial infarction or cerebrovascular accident in the year preceding the trial; connective-tissue disease; obstructive uropathy.

Keywords: advanced chronic renal insufficiency benazepril
study of an environmental risk factor in crohn's disease

Conditions: Inflammatory Bowel Diseases

Summary: inflammatory bowel disease (ibd) are lifelong chronic diseases affecting the gastrointestinal tract. the precise etiology and the different actors participating to the pathophysiological process leading to the disease development are still not well understood. a complex interaction between genetics, gut microbiota and environmental factors is thought to trigger the inappropriate mucosal immune response observed in ibd patients. we hypothesize that don might be an environmental risk factor for ibd.the focus on the human relevance of the gut effects of don by studying its exposure, metabolism and adverse effects in health and disease focusing on ibd patients


Eligibility criteria:
inclusion criteria: * group 1: patients with ileocolic crohn's disease requiring surgery * group 2: patients requiring ileal and / or colonic surgery for a reason other than crohn's disease or ulcerative colitis (for example, cancer, polyp or diverticulum). exclusion criteria: * vegetarian or vegan patients, celiac disease, gluten sensitivity, eating disorders, people with a particular diet or eating behavior or suffering from obesity or anorexia * surgical history: patient having undergone intestinal resection * current treatments: patient receiving antibiotic or probiotic treatment within 6 weeks prior to inclusion / patient having taken topical treatment (suppositories or enema of 5asa or corticosteroids) within 6 weeks prior to inclusion
testing product messages in colombia

Conditions: Obesity

Summary: purpose: to better understand the impact of different front-of-package labels (fopls) on consumer purchasing intentions and ability to identify unhealthy foods. participants: \~8,000 colombians, recruited from offerwise, that are 18 years or older. procedures (methods): participants will be randomly assigned to view images of food and drink products with either a nutrient warning label, guideline daily amount label, nutriscore label, or no-label control. they will be asked a series of questions about the products and the labels (excluding control group) on them. questions will also include standard demographic and health related variables.

participants will be recruited from offerwise (an online panel research company). following online consent, participants will be randomly assigned to view different labels (explained below) on food and drink packaging. participants will answer self-reported responses to the content (e.g., elaboration, beliefs, perceived healthfulness). after being randomized to one of the four groups and answering questions (e.g. which product is healthier, which product would you buy), the participant will see all three labels and select which is most dissuading from consuming a product high in a nutrient. at the end, the participant will answer demographic questions. participants will be randomized to see either a no-label control or 1 of 3 nutrient labels. the participants will see 5 types of products with the labels (fruit drinks, yogurt, sliced bread, cookies, and breakfast cereal). nutrient labels: 1. guideline daily amount label 2. nutriscore label 3. adapted peruvian nutrient warning label (high in sugar, high in saturated fat, high in salt/sodium)

Eligibility criteria:
inclusion criteria: * 18-64 years old * resident of colombia * offerwise panel member (recruitment platform) exclusion criteria: * \ 64 years old * not a resident of colombia
enac blockade and arterial stiffness

Conditions: Overweight and Obesity; Insulin Resistance

Summary: to determine whether treatment with the enac inhibitor, amiloride, improves endothelial function and arterial stiffness in obese insulin resistant subjects in a randomized placebo-controlled trial examining pre and postmenopausal women and age-matched men.

overweight/obese males, pre- and post-menopausal females with insulin resistance, 30-70 years of age will be recruited. following screening, eligible men and women will be randomly assigned to either amiloride (max dose 5mg) or placebo in a double-blinded design manner. after randomization, subjects will be scheduled for an outpatient visit to the undergo baseline assessment of arterial stiffness (carotid femoral pulse wave velocity - cfpwv) and endothelial function (brachial popliteal artery flow mediated dilation). subject assessment will be repeated at 12 weeks and at 24 weeks.

Eligibility criteria:
inclusion criteria: * 30 to 70 years of age at randomization * body mass index (bmi) 25.1-50 kg/m2 or waist circumference \> 88 cm (\> 35 in) in women and \>102 cm (\>40 in) in men. 3, 4 * one other characteristic of metabolic syndrome (elevated triglycerides ≥150 mg/dl; hdl cholesterol \ 10 mu/l (correlates with insulin resistance). exclusion criteria: 1. history of type 1 or type 2 diabetes 2. known cardiovascular events within the last 12 months (stroke, acute coronary event, revascularization, heart failure hospitalization). 3. history of uncontrolled thyroid disease, chronic liver disease (cirrhosis) or gfr \<50 ml/min. 4. use of potassium sparing medications (angiotensin ii receptor blockers, angiotensin converting enzymes inhibitors or mineralocorticoid receptor blockers) or use of potassium supplements. 5. active cancer (this criterion does not apply to those subjects with basal cell carcinoma or stage 1 squamous cell carcinoma of the skin) 6. excessive alcohol consumption (\>14 drinks/week for men, \>7 drinks/week for women) 7. current tobacco use 8. non controlled hypertension 9. participation in regular exercise \> 3 days/wk per week at a moderate or vigorous intensity 10. pregnancy or lactation in women (or women not using contraceptives) 11. women who plan to become pregnant during the duration of the trial 12. chronic use of nsaids 13. potassium level \> 5.0 mqe/l at time of screening 14. blood pressure at screening \<110/70
computed tomography (ct) guided lung biopsy: core or fine needle aspiration

Conditions: Lung Cancer

Summary: this study is a comparison of core needle biopsy with fine needle aspiration biopsy in the evaluation of lung nodules.


Eligibility criteria:
inclusion criteria: * all patients having a lung biopsy exclusion criteria: * lymphoma
the listening project: tuning into change

Conditions: Auditory Perceptual Disorders; Stress Disorder

Summary: a research project funded by the australian childhood foundation (acf) will be conducted in australian facilities of the acf to evaluate the effectiveness of the listening project protocol (lpp) in children with a trauma history. the lpp is designed as a "neural exercise" to reduce auditory hypersensitivities, to improve auditory processing of speech, and to improve behavioral state regulation. the lpp uses acoustic stimulation to exercise the neural regulation of the middle ear structures to rehabilitate and to normalize the acoustic transfer function of the middle ear structures. the current study is being conducted to evaluate efficacy and feasibility of the lpp and will use objective measures to evaluate changes in acoustic transfer function of the middle ears structures, auditory processing skills, physiological state regulation, and sensory symptoms.


Eligibility criteria:
inclusion criteria: * children must be between ages 7-14 years * children and parent providing permission must be able to read/speak in english * children must be receiving services from the child trauma service unit of the australian childhood foundation exclusion criteria: * children who wear a hearing-device * children with a history of heart disease * children who are currently being treated for seizure disorder

Keywords: autonomic nervous system auditory processing disorder social behavior
evaluation of hearing protection fit testing program

Conditions: Hearing Loss

Summary: the specific aim of this research is to evaluate the performance, effectiveness, and long-term training benefits of a formal hearing protection fit testing program. this study may provide preliminary evidence on the benefits of direct education/training combined with a formal hearing protection device (hpd) fit testing on hpd fittings on united states air force (usaf) employees. currently, public health provides informal, subjective training to employees; this practice may be altered by the results of this study.


Eligibility criteria:
inclusion criteria: * subjects must be enrolled in the hearing conservation program, and can be civilian or active duty/uniformed. subjects must be currently using some form of in-the-ear hearing protection device on a regular basis and have ear canals free of cerumen, infection, or any other obstruction. exclusion criteria: * not enrolled in the hearing conservation program. not using in-the-ear hearing protection device on a regular basis. ear canals containing cerumen, infection, or other obstructions.

Keywords: hearing conservation personal attenuation rating earplug
identification of endometriosis and migraine criteria in women with the comorbidity of both conditions in comparison with women who only suffer from endometriosis - a pilot study

Conditions: Endometriosis; Migraine

Summary: patients with both, migraine and endometriosis, present the case-group, while women with endometriosis without migraine serve as controls. the primary endpoint is endometriosis stage confirmed by laparascopy compared to the control group. further points to compare between groups are infertility, dysmenorrhea, dyschezia, dyspareunia, number of operations, family history with first-degree relatives, and age of first symptoms for both conditions and age at first operation. secondary endpoints to evaluate in percentages within the migraine group are migraine frequency, migraine aura/non-aura, age at migraine start, hormonal migraine, family history, treatment response, response to prophylactic agents, localization, types of aura and triggers. other medical conditions and comorbidities like depression will be noted as well as response to dienogest treatment. in the questionnaire we will ask 62 questions overall. the questions for endometriosis are based on a questionnaire from the world endometriosis research foundation and to evaluate the severity of the migraine we will use the midas (migraine disability assessment) questionnaire (8).


Eligibility criteria:
inclusion criteria: * premenopausal women aged 18-55 years, at time of operation * endometriosis confirmed with surgery and histologic staging (report of the surgery available) * for the cases migraine needs to be confirmed during the interview according to the ihs criteria. exclusion criteria: • inability to perform the interview (insufficient knowledge of language, psychological disorder, dementia)
beta-blocker administration for cardiomyocyte division

Conditions: Tetralogy of Fallot; Double Outlet Right Ventricle

Summary: heart failure is a common long-term complication in patients with congenital heart disease (chd). medical treatments to promote regeneration of new healthy heart muscle cells have the potential to provide new heart failure treatments for these patients. the development of such therapies is limited by the poor understanding of the ways in which heart muscles grow after birth. investigators have learned that humans without heart disease generate new heart muscles cells up to the age of 20 years old and that this is decreased in patients with congenital heart disease like tetralogy of fallot. investigators are trying to determine if treatment with a medicine called propranolol can increase heart muscle cell proliferation and, with that, normalize heart growth. investigators will examine discarded heart muscle tissue that is obtained during surgery for the presence of new heart muscle cells. propranolol is approved by the food and drug administration (fda) to treat a certain kind of benign tumor in infants (hemangioma), but it is not currently approved by the fda to increase heart muscle growth.


Eligibility criteria:
inclusion criteria: * male and female infants \< 45 days of age with a diagnosis of tetralogy of fallot with pulmonary stenosis or double outlet right ventricle, tetralogy type by echocardiogram, who weigh greater than 2 kg at the time of consent and are tolerating enteral feeds. * dorv variant exclusion criteria: * congenital atrio-ventricular block on ekg (pr interval \> 120 ms), * concomitant medication administration that interacts with propranolol, * patient family is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason, * gestation age \< 35 weeks, * infants of diabetic mothers, asthma or underlying respiratory disease, * presence of metal implants in infants.

Keywords: tetralogy of fallot double outlet right ventricle
the electroencephalogram analysis in the differences between inhalation anesthetic and propofol.

Conditions: Sevoflurane; Propofol

Summary: the investigators will record 120 patients who received general anesthesia, their eeg data recorded from bispectral index (bis) machine for emperical mode decomposition (emd) analysis, the investigators decomposed eeg signal to different oscillations and tried to observe the differences between hypnotic medications through eeg analysis.

the electroencephalography (eeg) is a noninvasive medical technique for monitoring and recording the electrical activity of brain. the hilbert-huang transform (hht) was proposed to decompose eeg signal into intrinsic mode functions (imf) which can obtain instantaneous frequency data and work well for data that is nonstationary and nonlinear. the relationship between frontal eeg patterns and hypnotics remain poorly understood. the investigators only can tell the increase in frontal eeg power and shift power to lower frequencies during general anesthesia from publications. the investigators are going to decompose eeg with hht and find the energy shift during general anesthesia, compare with different anesthetics. the investigators will record 120 patients who received general anesthesia, their eeg data recorded from bis machine for emd analysis, the investigators decomposed eeg signal to different oscillations and tried to observe the differences between hypnotic medications through eeg analysis.

Eligibility criteria:
inclusion criteria: * asa i-ii * scheduled surgery who need general anesthesia exclusion criteria: * allergy to the bis patch * not suitable for general anesthesia
a 3-arm study comparing the efficacy of anti-reflux reconstruction protocols after laparoscopic proximal gastrectomy

Conditions: Anti-Reflux Alimentary Reconstruction; Laparoscopic Proximal Gastrectomy; Siewert Type II/III Adenocarcinoma of the Esophagogastric Junction

Summary: the efficacy of three different alimentary reconstruction methods after proximal gastrectomy will be investigated in this study in a prospective, multicenter, randomized controlled trial.

in the trial, 180 patients with early upper-third early gastric cancer and siewert type ii/iii esophagogastric junction cancer will be enrolled and then randomly assigned to one of three groups: group a (single-tract jejunal interposition n = 60), group b (double-tract reconstruction, n = 60), or group c (tube-like stomach reconstruction, n = 60). the primary co-end points were the incidence of reflux esophagitis at 2 years postoperatively. the secondary end points included the incidence of anastomotic leakage and anastomotic stenosis, operative time, intraoperative blood loss, quality of life, overall survival, and disease-free survival. quality of life outcomes were assessed using the european organization for research and treatment of cancer quality of life questionnaire (eortc qlq) 30-item core questionnaire (c30) and the eortc qlq stomach cancer-specific questionnaire at 3 months, 12 months, and 24 months.

Eligibility criteria:
inclusion criteria: 1. age between 18-75 years old, male or female; 2. eastern cooperative oncology group (ecog) performance status of 0 (indicating fully active and able to continue all predisease activities without restriction) or 1 (indicating restricted in physically strenuous activities but ambulatory and able to perform work of a light or sedentary nature); 3. american society of anesthesiology physical status classification of i (indicating normal and healthy), ii (indicating mild systemic disease), or iii (indicating severe systemic disease); 4. pathological diagnosis of preoperative endoscopic biopsy: the tumor is located in the upper 1/3 of the stomach (including the esophagogastric junction), and the clinical staging of gastric cancer ia and ib (t1n0m0, t1n1m0, and t2n0m0) (14) according to the eighth edition of the ajcc; 5. patients without contraindications to surgery; 6. voluntary participation by signing the written informed consent form approved by the institutional review board before study participation; exclusion criteria: 1. receipt of chemotherapy or radiotherapy for the treatment of gc before either surgical procedure 2. combined resection required due to other diseases (except cholecystectomy). 3. history of cancer or concurrent cancer in other organs. 4. previous or current receipt of treatment for systemic inflammatory disease or history of gastrectomy. 5. patients with coagulation dysfunction which could not be corrected; 6. vulnerable status (eg, lacking decision-making capacity, pregnant, or planning to become pregnant). 7. receipt of chemotherapy or radiotherapy before either surgical procedure.
cognitive status after removal of skull base meningioma

Conditions: Meningioma; Skull Base Meningioma; Frontal Meningioma; Temporal Meningioma; Cognitive Impairment; Cognitive Decline; Post-Surgical Cognition

Summary: the purpose of this prospectively enrolling trial is to assess long-term cognitive outcomes of patients undergoing surgery for resection of a meningioma associated with the frontal and temporal lobes.

this study will look at patients who are undergoing resection of a skull based meningioma, located in the frontal or temporal lobe, via craniotomy or via endoscopic endonasal approach. the study will compare cognitive function at baseline, at six weeks postoperatively and at one year postoperatively. the cognitive testing being done at baseline will be a clinical care set of assessments done by the speech language pathology team and will include the rbans tests, the moca, promis-29, and neuroqol-cognitive functions.

Eligibility criteria:
inclusion criteria: * subject has a meningioma associated with the frontal or temporal lobes * subject is scheduled to undergo open craniotomy or endoscopic endonasal surgery * subject is 18 years of age or older * the subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent * previous surgery will not exclude the patient as a new baseline cognitive evaluation will occur. exclusion criteria: * patient is a prisoner * patient is 90 years of age or older * pregnant women * previous radiation to the brain
clinical and dosimetric study of patients treated with 177lu-psma-617 for prostate cancer.

Conditions: Prostate Cancer; Metastasis

Summary: single-centre, retrospective and prospective observational study. this study aims to evaluate the dose delivered by radiation to the tumour and organs at risk, as a factor predicting response and the appearance of toxicities. dosimetric calculations are made for each treatment using scintigraphic images acquired following injection of 177lu-psma-617.

the management of patients and the administration of treatment with 177lu-psma are carried out in the usual way in the nuclear medicine department of the institut bergonié, and are not modified in any way. the treatment regimen is standard, with 6 cycles spaced 6 weeks apart at a fixed dose of 7.4 gbq. patients are selected on the basis of a 68ga-psma-11 pet/ct scan to assess whether psma is properly expressed. only data are collected for the study and they are derived from the usual management of patients treated with 177lu-psma at the institut bergonié: information on the treatment, anatomical data and 177lu-psma fixation in lesions and tissues, scintigraphic images acquired post-treatment, data on monitoring the effects of the treatment, 68ga-psma pet/ct images.

Eligibility criteria:
inclusion criteria: 1. patient aged 18 and over. 2. patient with indication for or having started or completed treatment with 177lu-psma-617 since 01/11/2023: 1. progressive, metastatic, castration-resistant prostate cancer, 2. overexpressing prostate specific membrane antigen (psma) 3. treated with taxane chemotherapy and at least one 2nd generation hormone therapy (apalutamide, enzalutamide, darolutamide, abiraterone-prednisone). 3. patient able to lie still for 1 hour for image acquisition. 4. patient's place of residence \< 2 hours' drive from the institut bergonié. 5. patient has not expressed any opposition to the use of his/her medical data for research purposes. exclusion criteria: none

Keywords: radiopharmaceutical drug