Kornimate/medical-research-clean huggingface dataset:
pharmacovigilance assessment of reporting of cardiovascular adverse events with antineoplastic agents (parca)

Conditions: Cardiovascular Diseases; Cardiac Diseases; Vascular Diseases; Cancer

Summary: the aim of this observational study is to explore and analyze reports of cardiac or vascular adverse events linked to the administration of antineoplastic agents among patients diagnosed with tumors represented by advanced non-small cell lung cancer. the study leverages pharmacovigilance databases such as the world health organization (who) database (vigibase), fda adverse event reporting system (faers), and others to gather individual safety case reports for analysis.

concomitant antineoplastic drug therapy may produce serious adverse cardiac or vascular system events. in this study, reports of cardiovascular adverse drug events following treatment with antineoplastic drugs were investigated using the world health organization (who) personal safety case report database (vigibase) and fda adverse event reporting system (faers).

Eligibility criteria:
inclusion criteria: 1. case reported in vigibase, faers and other pharmacovigilance databases of individual safety case reports to 12/31/2024. 2. adverse events reported were including the meddra terms: cardiac disorders (soc), vascular disorders (soc), cardiac and vascular investigations (excl enzyme tests) (hlgt), sudden death (pt), sudden cardiac death (pt), cardiac arrhythmias (hlgt), cardiac disorder signs and symptoms (hlgt), cardiac neoplasms (hlgt), cardiac valve disorders (hlgt), coronary artery disorders (hlgt), endocardial disorders (hlgt), heart failures (hlgt), myocardial disorders (hlgt), pericardial disorders (hlgt), vascular disorders nec(hlgt), vascular inflammations(hlgt), embolism and thrombosis(hlgt), vascular hypertensive disorders(hlgt), blood pressure disorders nec(hlgt), venous varices(hlgt), arteriosclerosis, stenosis, vascular insufficiency and necrosis(hlgt), aneurysms and artery dissections(hlgt). 3. patients treated with antineoplastic agents (including small-molecule kinase inhibitors, immune checkpoint inhibitors, monoclonal antibodies, cytotoxic drugs, and other therapeutics). 4. the number of reports corresponding to each drug or adverse event is at least three. 5. the primary indication is malignant tumors, specifically advanced non-small cell lung cancer. exclusion criteria: 1. any of the information in the baseline information such as gender, age, region, date of report is empty. 2. the severity level of the reported adverse event is empty. 3. adverse events were reported in patients whose drug indications included cardiovascular disease.
shape of the sagittal curvatures of the spine in youthful female volleyball players

Conditions: Healthy

Summary: the goal of this study is to assess the formation of the sagittal curvatures of the spine in healthy girls practicing volleyball versus their untrained peers. research questions: 1. is there a differentiation in values of thoracic kyphosis, lumbar lordosis angles, and compensation ratio among girls practicing volleyball and their untrained peers? 2. does practicing volleyball determine the frequency of correctness in the lumbosacral inclination, the shape of the curvature of the thoracic kyphosis and lumbar lordosis? 3. does practicing volleyball determine the frequency of types and subtypes of body posture?

the investigators compared 30 healthy girls aged 10-13 (attending training regularly, three times a week), with 30 healthy peers who did not train in any sports and did not regularly participate in any physical exercises apart from attending obligatory physical education classes. the baseline bubble inclinometer was applied as the research tool of choice. the study protocol entailed the measuring of the sagittal curvatures of the spine.

Eligibility criteria:
inclusion criteria: * age range of 10-13 years, * dominating right hand and right leg, * a written informed consent to participate in the study. exclusion criteria: * injuries of the musculoskeletal system, * pathology of the limbs, * previous orthopedic surgery, * neurological disorders, * refusal to participate in the study.

Keywords: sport training kyphosis lordosis health
randomized-controlled trial of the effectiveness of covid-19 early treatment in community

Conditions: Treatment Efficacy

Summary: there is an urgent need to identify effective treatments for sars-cov-2 infection that helps people recover quicker and reduces the need for hospital admission. the investigators develop an open, adaptive, platform trial to evaluate treatments, fluvoxamine, bromhexine, cyproheptadine, and niclosamide suitable for use in the community for treating covid-like-illness that might help people recover sooner and prevent hospitalisation.

there is an urgent need to identify interventions against covid-19 suitable for wide use in the community that have been proven to be effective in reducing symptom duration or hospitalisation. there is urgent need to know whether potential covid-19 treatments such as fluvoxamine, bromhexine, cyproheptadine, and niclosamide that are available for rapid pragmatic evaluation might modify the course of covid-19 infections, particularly among those who are at higher risk of complications, such as those aged 50 years and over with comorbidity and those aged 65 years and over. most reported trials have been conducted in hospital settings, and there is little evidence from community settings, where most people with covid-19 receive care and where deployment of effective early treatment could speed time to recovery and reduce complications. the investigators established a multi-arm, adaptive platform, randomised controlled trial for community treatment of covid-19 syndromic illness in people at higher risk of an adverse illness course.

Eligibility criteria:
inclusion criteria: * covid-1 9 patients with mild symptoms and the results were confirmed by antigen test kit or pcr for sars-cov-2. * people who have symptoms consistent with covid-19 and test positive for sars-cov-2 infection within 48 hours of being known. * participants are 18 years of age or older. exclusion criteria: * almost recovered (generally much improved and symptoms now mild or almost absent) * judgement of the recruiting clinician deems ineligible. * previous randomisation to an arm of the trial * pregnancy * breastfeeding * known severe hepatic impairment. * known severe renal impairment. * currently taking fluvoxamine, bromhexine, cyproheptadine, or niclosamide

Keywords: covid-19 coronavirus treatment viral shedding coronavirus infections respiratory tract infections anti-infective agents fluvoxamine bromhexine cyproheptadine niclosamide pneumonia, viral early treatment
serum rennin kinetics versus serum lactate kinetics as predictors of mortality in septic shock patients

Conditions: Septic Shock

Summary: whole blood lactate concentration is widely used in shock states to assess perfusion. we aimed to determine if the change in plasma renin concentration over time would be superior to the change in lactate concentration for predicting in-hospital mortality in septic shock patients.

resuscitation in the icu was traditionally based on blood pressure (1, 2). an assumption that adequate tissue perfusion cannot be made at pressures of 65 mm hg, and the number itself has been challenged in other investigations (1, 3, 4). lactate has long been regarded as an adequate indicator of tissue perfusion and prognosis. most critical care resuscitation are guided by serial lactate levels as a mean to understand the flow and perfusion side of resuscitative aims (2, 5). not all high lactate levels are indicators of poor tissue perfusion (6).in 2017, khanna et al (7) reinvigorated the interest in the renin-angiotensin-aldosterone system (raas) as a significant biochemical hormonal axis and feedback mechanism in vasodilatory shock after they published the results of the angiotensin ii in high output shock trial. gleeson et al (8) showed in 2018 that renin appeared to be a much stronger and significant predictor of icu mortality compared with lactate in a heterogenous shock population jeyaraju et al (9) reported that renin kinetics are superior to lactate kinetics for predicting in-hospital mortality in critically ill patients with hypotension, with most being vasodilatory shock (most common diagnosis sepsis, also vasoplegia, acute respiratory distress syndrome \[ards\], liver failure) and those who had hypotension more than 6 hours while of vasopressors included. the bottom line in the previous investigations is that renin was a better marker of poor outcomes in comparison with concurrently measured lactate levels in critically ill icu patients.

Eligibility criteria:
inclusion criteria: * age over 18 * anticipated stay \>24 hours * signed informed consent by patient or next-of-kin. * septic shock patients, septic shock was defined as persistent hypotension (defined as the need for vasopressors to maintain mean arterial pressure ≥ 65 mm hg, and a serum lactate level \> 18 mg/dl \[2 mmol/l\] despite adequate volume resuscitation exclusion criteria: * chronic kidney disease stage iv/v (baseline egfr (estimated glomerular filtration rate) \<30ml/min/1.73m2), * do not resuscitate order.
ischemic time and extent of myocardial infarction (mi) with cardiac magnetic resonance imaging (cmri) in patients with st elevation myocardial infarction (stemi) and primary percutaneous coronary intervention (pci) study

Conditions: Acute Myocardial Infarction

Summary: this study will assess relationship between ischemic time and the extent of myocardial infarction with cardiac magnetic resonance image in patients with stemi (st elevation myocardial infarction) and primary percutaneous coronary intervention.

background: cardiac magnetic resonance image (cmri) is the preferred method of assessing myocardial infarct size and function. however,the relationship between cmri changes and the ischemic time \[symptom onset to device activation time (s2d)\] in patients with primary percutaneous coronary intervention (pci) is not well understood. hypothesis: the investigators will test the primary hypothesis that there is strong (at least 70%) direct correlation between the s2d time and infarct size by cmri and inverse correlation with myocardial salvage. method: the investigators will study a prospective cohort of 80 consecutive patients with stemi and primary pci. the investigators will perform cmri at day 3 to 1 post stemi and a repeat cmri 30 to 40 days post stemi. exclusion criteria: the investigators will exclude patients with 1)-culprit lesion in the distal artery, 2)-glomerular filtration rate (gfr) \ 400lb, 5)-history of allergic reactions to gadlinium based contrast agents, and 6)-those unwilling to participate in the study protocol. outcome measurement: the primary outcome measure is the cmri myocardial infarct size (scar). the secondary outcomes include the cmri transmurality of scar, area at risk, myocardial salvage index, microvascular obstruction (mvo), left ventricle (lv) thrombus, and lv ejection fraction (ef). important covariates include symptoms and st segment resolution before and after the pci, peak cardiac troponin (ctn), and angiographic timi flow and myocardial perfusion grade. follow-up: patients will be followed with repeat cmri at 30 to 40 days and with phone survey at 6 months and 12 months.

Eligibility criteria:
inclusion criteria: clinical features, ekg, ctn elevation, and coronary catheterization findings consistent with an acute stemi and having primary pci, with age greater than 18 years, and gfr \>= 60 ml/min/1.73m2. exclusion criteria: 1. renal dysfunction (creatinine clearance \< 60 ml/min/1.73m2) 2. pregnancy or breast-feeding 3. standard contra-indications to mri for implanted ferro-magnetic devices - i.e.: pacemakers, defibrillator (aicd), and aneurysm clips 4. body weight \> 400lb 5. unwilling to participate in the research protocol 6. history of allergic reactions to gadlinium based contrast agents. 7. too critically ill to receive a mri
a randomized, double-blind study to evaluate the safety, tolerability, and pharmacodynamics of a single dose of intravenous td-8954 compared with metoclopramide in critically ill patients with enteral feeding intolerance

Conditions: Enteral Feeding Intolerance

Summary: this study is being conducted to evaluate the safety, tolerability and early efficacy of iv td 8954 compared to metoclopramide in critically ill subjects, aged 18 to 85 years, who are admitted to the intensive care require mechanical ventilation, and are intolerant to enteral feeding.


Eligibility criteria:
inclusion criteria: * intubated, on mechanical ventilation, and anticipated to remain on mechanical ventilation for 2 days after enrollment into the study * receiving enteral feeding and assessed to have developed efi, as defined by a grv measurement ≥250 ml within the 24 hours before randomization exclusion criteria: * history of diabetic or idiopathic gastroparesis * screening blood glucose \>15 mmol/l (270 mg/dl) while receiving insulin * impaired renal function, as defined by estimated glomerular filtration rate (egfr) \ 2 times the upper limit of normal * alt or ast \>3 times upper limit of normal * alkaline phosphatase \>2 times upper limit of normal * contraindication to enteral feeding * opioid or other drug overdose as the primary reason for admission to intensive care unit (icu) * receipt of a drug that can be used as a gastric prokinetic agent * receipt of agents known to directly influence the 5 ht4/acetylcholine prokinetic mechanism

Keywords: enteral feeding
banded versus non-banded roux-en-y gastric bypass

Conditions: Morbid Obesity

Summary: this is a prospective randomized study comparing weight loss, esophageal motility and reflux in lap. gastric bypass vs. lap. banded-gastric bypass using the a.m.i. soft gastric bypass band (b-band.


Eligibility criteria:
inclusion criteria: * bmi \> 40 or bmi \> 35 + hypertension/diabetes mellitus * ph metry and manometry preoperatively exclusion criteria: * formerly operations of the stomach * formerly open abdominal surgery * malignancy within the last 5 years * formerly gastric banding

Keywords: gastric bypass banded gastric bypass weight loss weight regain bariatric surgery
belgian pulmonary function study

Conditions: Respiratory Symptoms

Summary: pulmonary function tests including spirometry, lung volumes, measurements of resistance and diffusing capacity are essential in the diagnosis of several pulmonary diseases. these tests are an integral part of the diagnosis and treatment of lung diseases, but until now there is no clear evidence for the use of many of the pulmonary function tests because of a lack of adequate studies. the obscurity largely pertains to the conditions under which combinations of the various tests are indicated. therefore the belgian thoracic society, assembling all pulmonologists and the pneumology lok/glem"s, will investigate this matter.


Eligibility criteria:
inclusion criteria: * males and females * age between 18 and 75 years old * new outpatients with respiratory symptoms as dyspnoea, cough, sputum, but without firm diagnosis * results of the tests are available and acceptable * standardized list of complaints * capability of patient for doing pulmonary function tests * seen by a pneumologist * written informed consent exclusion criteria: * patients with diagnosed respiratory disease * younger than 18 and older than 75 years old * recent heart attack * pneumothorax * hemoptoic * suspicion of tuberculosis * not capable to do pulmonary function tests

Keywords: caucasian outpatients undiagnosed respiratory symptoms dyspnea cough sputum
geriatric fracture centers - evaluation of a geriatric co-management program

Conditions: Hip Fractures

Summary: the study will assess patients with at least one major ae related to treatment / hospitalization / immobilization in the geriatric fracture center (gfc) group compared to the usual care group.

patients aged ≥ 70 years or older with an osteoporotic hip fracture treated with an osteosynthesis or endoprosthesis will be included in this study. the primary objective of the study is to assess the difference in the numbers of pre-defined major adverse events (ae) which are related to the treatment, hospitalization and/or immobilization between patients who were treated in a geriatric fracture center or in a usual care center. as a secondary objective, health economic implications and cost-effectiveness comparison analyses will be performed. in order to be able to analyze data based on the geographic regions as well as globally, in each participating country, both a geriatric fracture center (gfc) and a usual care center (ucc) will be included.

Eligibility criteria:
preoperative inclusion criteria: * age ≥ 70 years * geriatric patients with hip fractures treated either with oosteosynthesis or oendoprosthesis * ability of the patient or assigned representative to understand the content of the patient information / informed consent form * signed and dated institutional review board (irb) / ethics committee (ec)-approved written informed consent preoperative exclusion criteria: * recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment * prisoner * participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Keywords: geriatrics [mesh] osteoporotic fractures [mesh] hip fractures [mesh] cost benefit analysis [mesh] quality of life [mesh] mortality [mesh] complications
reconstructing consciousness and cognition

Conditions: Postoperative Cognitive Dysfunction

Summary: currently it is unknown how the human brain reorganizes its network organization to generate conscious experience and cognitive activity after a period of unconsciousness. therefore, the purpose of this study is to assess how cognitive activity is reconstructed after general anesthesia. the investigators hypothesize that the brain's transition from unconsciousness to consciousness and full cognition is a complex process that occurs over an extended period of time. specifically, the investigators hypothesize the following order of cognitive reconstitution: responsiveness to command, attention, complex scanning and visual tracking, working memory, and executive function. volunteers will be healthy participants who are anesthetized with commonly used anesthetic drugs as well as a non-anesthetized group to control for circadian influences. a total of 60 subjects will be recruited for this study. all subjects (male and female) will perform basic tests for cognition on a laptop computer at 30-minute intervals during this study. the testing battery to be administered was assembled to assess multiple cognitive functions in order to determine whether and how cognitive processes return to baseline function. electroencephalogram (measuring brain electrical activity) data will be monitored and recorded during both anesthesia and cognitive testing, for subsequent analysis. this study is significant because it could lead to a better understanding of the neural correlates of human consciousness, as well as normal and abnormal conscious state transitions (including barriers to such transitions).


Eligibility criteria:
inclusion criteria: * healthy 20-40 year old volunteers, * american society of anesthesiologists physical status i or ii (i.e., healthy), * body mass index \< 30 kg/m2, * easily visualized uvula, * with anticipated equal recruitment of males and females. exclusion criteria: * physical signs suggestive of difficult airway (e.g., mouth opening \<3cm, short distance between the chin and neck, poor mandibular subluxation, thick neck), * history of obstructive sleep apnea, * reactive airway disease, * neuropsychiatric disorders, * history or current use of psychotropic medications, * current tobacco and alcohol use, * history of hypertension or current medication for blood pressure control, cardiovascular disease or arrhythmias, * positive urine toxicology screen, * history of reflux, * pregnancy, * family history of problems with anesthesia (including but not limited to malignant hyperthermia), * sleep disorders, * history of postoperative nausea/vomiting or motion sickness, * allergy to eggs, egg products or soy.

Keywords: general anesthesia cognition consciousness
exercise training associated with inspiratory muscle training in heart failure

Conditions: Heart Failure

Summary: the investigators hypothesize that aerobic exercise training associated with respiratory muscle training will cause additional benefits compared to isolated exercise training or respiratory training in chronic heart failure patients.

the investigators hypothesize that aerobic exercise training associated with respiratory muscle training will cause additional benefits in the autonomic control and respiratory function compared to isolated exercise training or respiratory training in chronic heart failure patients.

Eligibility criteria:
inclusion criteria: * patients with systolic heart failure and new york heart association (nyha) class ii-iii * left ventricular ejection fraction less than 40% * peak oxygen consumption less than 20 ml/kg/min exclusion criteria: * chronic obstructive pulmonary disease * neuromuscular, orthopedic, neurologic and neoplastic diseases * recent myocardial infarction or cardiac surgery (less than 6 months) * unstable angina pectoris * atrial fibrillation * pacemakers users * actual smoker * pregnant * changing medication or hospital admission

Keywords: heart failure exercise and physical fitness
a study to test how well healthy men tolerate different doses of bi 1356225

Conditions: Healthy

Summary: the main objectives of the srd part of this trial are to investigate safety, tolerability, pharmacokinetics (pk) and pharmacodynamics (pd) of bi 1356225 in healthy male subjects following oral administration of single rising doses. the main objective of the ba part of this trial will be to explore the influence of food on the bioavailability of tablet fasted versus tablet fed


Eligibility criteria:
inclusion criteria: * healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (bp, pr), 12-lead ecg, and clinical laboratory tests * age of 18 to 45 years (inclusive) * bmi of 18.5 to 29.9 kg/m2 (inclusive) * signed and dated written informed consent prior to admission to the study, in accordance with gcp and local legislation exclusion criteria: * any finding in the medical examination (including bp, pr or ecg) deviating from normal and assessed as clinically relevant by the investigator * repeated measurement of systolic blood pressure outside the range of 90 to 140 mmhg, diastolic blood pressure outside the range of 50 to 90 mmhg, or pulse rate outside the range of 50 to 90 bpm * any laboratory value outside the reference range that the investigator considers to be of clinical relevance * any evidence of a concomitant disease assessed as clinically relevant by the investigator * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) * diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders * further exclusion criteria apply