Kornimate/medical-research-clean huggingface dataset:
registry on augmented antithrombotic treatment regimens for patients with arterial thrombotic aps

Conditions: Antiphospholipid Syndrome; Arterial Thrombosis

Summary: the goal of this registry is to gather more information on the efficacy and safety of various antithrombotic regimens. the registry collects data on patients with antiphospholipid syndrome and an arterial event within the past 12 months, on treatment with either a) a vka with therapeutic range, inr 2.0-3.0 plus low-dose aspirin (75-100 mg daily), b) a vka alone with therapeutic range, inr 2.0-3.0, c) a vka with therapeutic range, inr 3.0-4.0, or d) with a dual antiplatelet regimen. the follow-up is 2 years.

the optimal antithrombotic management of patients with antiphospholipid syndrome and arterial thrombotic events is unclear. the guidelines provide several options, mostly with vitamin k antagonist with/without an antiplatelet agent. dual antiplatelet therapy (dapt) was in a meta-analysis potentially effective, but included studies were few and small. the primary aim is to compare a vitamin k antagonist (vka), i.e. warfarin, acenocoumarol, phenprocoumon etc, with international normalized ratio 2.0-3.0 plus low-dose aspirin (75-100 mg) with dapt - typically low-dose aspirin plus clopidogrel (75 mg daily) but other combinations will be acceptable. the registry will also include patients treated with vka alone at standard- or high-intensity, since this is recommended and will serve as reference groups in comparison with vka + low-dose aspirin and versus dapt. the outcomes are (efficacy) arterial or venous thromboembolism, vascular death or (safety) major bleeding. a secondary objective is to analyze how the cardiovascular risk factors (hypertension, hyperlipidemia, obesity, smoking, diabetes, and heart failure), venous thrombotic risk factors (previous venous thromboembolism, cancer, immobility, chronic inflammatory disease) and anti-phospholipid profile contribute to recurrent arterial thrombosis.

Eligibility criteria:
inclusion criteria: 1. patients of at least 18 years of age with confirmed antiphospholipid syndrome according to sydney criteria and with first or recurrent arterial thrombotic manifestation, including those with asymptomatic brain infarcts on diagnostic imaging. 2. treatment with either a) a vitamin k antagonist (vka) with therapeutic range, international normalized ratio (inr) 2.0-3.0 plus low-dose aspirin (75-100 mg daily), b) a vka alone with therapeutic range, inr 2.0-3.0 or c) vka with therapeutic range, inr 3.0-4.0, or d) with a dual antiplatelet regimen, if considered appropriate by the treating physician. 3. signed informed consent obtained (in jurisdictions where required). exclusion criteria: 1. inability to follow the patient due to geographical or other reasons. 2. patients with documented poor compliance. 3. bleeding risk that in the opinion of the treating physician makes combination antithrombotic therapy unsafe. 4. pregnancy or planned pregnancy. 5. venous thrombotic event diagnosed after the last arterial event.

Keywords: anticoagulation vitamin k antagonist antiaggregant stroke myocardial infarction hemorrhage
effect of exercise-education program permanento in late life

Conditions: Frailty; Sarcopenia

Summary: the general aim of the present study is to create and empirically evaluate (rct trial) an online education and exercise program (called permanento) to help older adults to understand the wider consequences of being active and offer them easy to follow exercise program inspired by developmental kinesiology.

there is no doubt about the importance of a physical activity at a later age, yet it is often missing in the lives of seniors and the current epidemiological situation deepens this deficit even further. it is known that insufficient physical activity has a major effect on the decline of functional fitness components, premature development of sarcopenia or frailty syndrome, threatening self-sufficiency, health and consequently quality of life. this is associated with an increased burden on the health care system and related social services, with implications for public budgets. the aim of this project is to eliminate the onset or premature manifestation of negative aspects of aging by prevention. the content is to research a unique intervention inspired by the principles of developmental kinesiology with a presumed positive effect on the health status and the development of a comprehensive exercise and educational program for older adults. the main planned result of the project is a methodological manual and a web application containing education and exercise program for both older adults as well healthcare professionals. the project responds to the priorities of the applied health research program for the years 2020-2026 and its focus contributes to a long-term solution of the population aging issue. with regard to demographic change, health and social care systems will be unsustainable without the adoption of preventive measures by seniors themselves. exercise-educational intervention can lead to lasting changes and can help seniors to actively and responsibly participate in the course of their own aging. main objective: to reduce negative health related aspects of aging, resp. their premature manifestation, by a preventive exercise-educational program. sub-objectives: - to develop a specifically targeted exercise-educational program; - to demonstrate effectiveness of the program on health and social related indicators; - to assess acceptability, sustainability and other personal contexts - to create a methodological manual and a web platform for home-dwelling as well as institutionalized older adults containing complex information for independent exercise (how, as well as why).

Eligibility criteria:
inclusion criteria: * permanent residency in prague * being at least 70 years of age or older * living independently at home exclusion criteria: * significant mobility limitation * any health condition preventing from physical activity

Keywords: prevention older adults functional status frailty sarcopenia exercise on-line program sustainability
open-label study of safety and tolerability of memantine in children with autism

Conditions: Autism; Pediatric Autism

Summary: the purpose of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of autism in pediatric patients.

this is a 48-week multicenter extension study comprised of a 6-week double-blind dose-titration period followed by a 42-week open-label maintenance period. in the forest autism trials conducted in children ages 6-12, dosing with an extended release formulation of memantine was weight-based. these weight based dose limits were selected to ensure exposure in terms of area under the curve (auc) was less than the predefined limit of 2100 ng∙h/ml that represented a 10-fold lower exposure than observed at the noael (no observed adverse effect level) of 15 mg/kg/day in juvenile rats. the weight-based dose limits in these studies were as follows: * group a: ≥ 60 kg; max 15 mg/day * group b: 40-59 kg; max 9 mg/day * group c: 20-39 kg; max 6 mg/day * group d: \< 20 kg; max 3 mg/day

Eligibility criteria:
inclusion criteria: * completed lead-in study mem-md-57a (nct00872898) * a knowledgeable caregiver capable of providing reliable information about the patient's condition, able to attend all clinic visits with the patient exclusion criteria: * patients with a concurrent medical condition that might interfere with the conduct of the study

Keywords: namenda autism memantine pediatric forest laboratories
global, regional, and national burdens and trends of tracheal, bronchial, and lung cancer in individuals aged 70 years and older from 1990 to 2021

Conditions: Lung Cancer Patients

Summary: despite the increasing health burden of tracheal, bronchial, and lung (tbl) cancer patients aged ≥ 70 years worldwide, data on its burden and trends are limited. this study aimed to analyze the global, regional, and national burdens and trends of tbl cancer from 1990 to 2021.

the latest cancer report indicates that tracheal, bronchial, and lung (tbl) cancer, the most widespread cancer globally, accounts for 12.4% of new diagnoses and 18.7% of cancer-related deaths, thereby presenting significant societal, public health, and economic challenges.despite the increasing health burden of tracheal, bronchial, and lung (tbl) cancer patients aged ≥ 70 years worldwide, data on its burden and trends are limited. this study aimed to analyze the global, regional, and national burdens and trends of tbl cancer from 1990 to 2021.

Eligibility criteria:
inclusion criteria: pathologic diagnosis of lung cancer exclusion criteria: breast cancer age less than 70 years
additive intra-ocular pressure reduction effect of fixed combination of maleate timolol 0.5%/dorzolamide 2% on monotherapy with latanoprost in patients with elevated intra-ocular pressure

Conditions: Glaucoma

Summary: the purpose of this study is to evaluate the additive effect of dorzolamide/timolol fixed combination in patients undergoing monotherapy with latanoprost.


Eligibility criteria:
inclusion criteria: all patients were at least 18 years old, with unilateral or bilateral open-angle glaucoma (defined as iop \> 21 mmhg, mean of three consecutive measurements, at any time during the day, at the moment of glaucoma diagnosis) or ocular hypertension (iop\> 25 mmhg, mean of three consecutive measurements, at anytime during the day, at the moment of diagnosis). glaucoma was defined as a reproducible glaucomatous visual field defect based on ght outside normal limits and/or psd lower than 0,5% or glaucomatous changes of the optic disc associated to elevated iop. a visual acuity (etdrs) of 20/80 or better was required for randomization. exclusion criteria: included woman of childbearing potential, pregnancy, systemic contra-indication to beta-blocker therapy, argon laser trabeculoplasty three months before screening visit, any history of filtering surgery, ocular surgery or uveitis three months before screening visit, hypersensitivity to any compound of the study drugs, concomitant use of any experimental drug, any condition in which treatment with beta-blocker is contraindicated or any other abnormal and/or ocular condition or symptom that would prevent study participation, according to the judgment of the investigator. the use of systemic beta-blocker, if needed, was allowed and not considered an exclusion criterion. latanoprost non-responders defined as lower than 15% iop reduction after run-in period with latanoprost monotherapy were excluded from the study.
immunogenicity and safety of rabies vaccine, administered with two different simulated post exposure schedules

Conditions: Rabies

Summary: this study was planned to establish the non-inferiority of rabipur administered as simulated post exposure zagreb schedule as compared to essen schedule, in healthy indian adult subjects.


Eligibility criteria:
inclusion criteria: 1. males and females of age ≥ 18 years. 2. individuals who had given written consent. 3. individuals in good health and available for all the visits scheduled in the study. exclusion criteria: 1. pregnancy or unwillingness to practice acceptable contraception. 2. a history of rabies vaccination. 3. history of allergy to egg protein. 4. known hypersensitivity to neomycin, tetracycline, amphotericin-b or any other vaccine component. 5. a significant acute or chronic infectious disease or use of antibiotics that may impact the subject's safety and /or immunogenicity in the investigators opinion at the time of enrolment. 6. body temperature ≥38.0°c (≥ 100.4°f) within 3 days of study vaccination. 7. treatment with an anti-malarial drug, up to two months prior to the study. 8. individuals who received any other vaccines within 28 days prior to enrollment. 9. subjects who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks. 10. any planned surgery during the study period. 11. subjects who have cancer disorders excluding nonmelanotic skin cancer.

Keywords: rabies rabies vaccines post-exposure prophylaxis
safety during use of paediatric triple chamber bag formulas

Conditions: Infant Nutrition Disorders; Infant, Premature, Diseases; Digestive System Disorders

Summary: the primary objective of this study was to provide daily information on the performance safety of the ped3cb in practical therapeutic use in pediatric patients.


Eligibility criteria:
inclusion criteria: * hospitalized preterm newborn infants, term infants and toddlers, and children and adolescents requiring parenteral nutrition (pn) for at least 5 consecutive days. * preterm infants were to require pn representing, at baseline, 80% of total estimated nutritional needs, and patients in the other groups (term infants toddlers; children) were to require pn representing, at baseline, at least 50% of total estimated nutritional needs. * patient whose parents or legally authorized representative had provided signed written informed consent exclusion criteria: * patients with a life expectancy \< 6 days or with a severe illness with foreseeable intercurrent events that could jeopardize the patient's participation in the study were not included in the study. * patients with a diagnosis of shock, cardiac or renal failure with fluid overload, metabolic acidosis, respiratory failure, signs of sepsis, severe dyslipidemia, uncorrected metabolic disorders, severe sepsis, severe liver disease including cholestasis icterus, blood coagulation disorders and/or thrombophlebitis, acute myocardial infarction, or hypersensitivity to the active substance or any of the excipients of the test product, were not included in the study. * patients with specific nutritional requirements that could not be met by ped3cb formulas were also excluded.

Keywords: parenteral nutrition multi chamber bag
magnetic imaging for diagnostic of amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis With Dementia

Summary: nearly 60% of amyotrophic lateral sclerosis (als) patients have a low level of diagnostic certainty (possible, probable) at the time of diagnosis. in the absence of biomarkers, this diagnosis is based, among other things, on the demonstration of the diffusion of signs of denervation by electroneuromyography (enmg). the objective of this study is to improve the earliness and the level of diagnostic certainty by better demonstrating the diffusion of the denervation process by whole body muscular mri.

the objective of this study is to show that the combination of enmg and whole body muscle mri (wb-mri) can increase the diagnosis of definite als at the onset of the disease for 50 consecutive patients with suspected als, the present study will prospectively perform needle electromyography (emg) and muscle analyses on whole body mri. the diagnostic category will be determined by revised el escorial criteria and awaji criteria. on whole body mri acquisition, for 83 muscles, will be explored fatty infiltration and atrophy on fat images (chronic denervation) and muscle edema on water images (acute denervation). emg studies will be performed in at least 10 muscles (tongue, biceps brachii, first dorsalis interosseous, t10 paraspinalis, vastus lateralis, and tibialis anterior). diagnostic classification according emg and/ or mri abnormalities in bulbar and the 3 spinal regions will be compared independently.

Eligibility criteria:
inclusion criteria: * consent form signed by the patient * patients suspected als defined according awaji shima criteria (possible, probable, defined) * clinical assessment of upper motor neuron involvement * electrophysiologic assessment of lower motor neuron involvement exclusion criteria: * inability to give informed consent * a contraindication to mri * respiratory failure impairing ability to lie flat in the scanner. * patient placed under judicial protection or under another protective regime, * females who are pregnant

Keywords: amyotrophic sclerosis
a prescription-event monitoring (pem) study of tiotropium

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this prescription-event monitoring study was based upon 'event' monitoring and so capable of identifying signals of events that might be associated with the use of tiotropium, which none of the participating general practitioners (gps) suspected to be an adverse drug reaction. the methodology of this study readily permits follow up of specific events and the obtaining of additional data as appropriate.


Eligibility criteria:
inclusion criteria: * patients who were prescribed tiotropium exclusion criteria: * not applicable
contrast enhanced endoscopic ultrasound in pancreas lesions

Conditions: Pancreatitis; Pancreas Cancer; Pancreas Cyst

Summary: the purpose of this study is to determine whether quantitative contrast-enhanced endoscopic ultrasound (ce-eus) improves the evaluation of pancreas tumors and precursor lesions, including cysts, compared to conventional endoscopic ultrasound.

the study is a prospective trial of ce- eus in which the conventional eus that is part of standard clinical care is conducted after injection of intravenous contrast agent. the study population will include those patients already undergoing endoscopic ultrasound for standard pancreatic indications at cedars-sinai medical center. the primary procedures will include conventional eus to evaluate a pancreatic lesion as part of standard of care, iv contrast agent during the procedure if deemed necessary by the investigator, collection of time intensity curves for pancreas and lesions from the eus processor. the study includes one standard of care visit for eus, and the enrollment period will be 24 months. all enrolled patients will be followed by chart review or phone call for a period of 12 months. all of the subjects will be undergoing an eus for standard of care. these patients will also receive an iv contrast agent (lumason) during the procedure, which is not part of standard of care, and is for research use only. fna will be performed only on those patients deemed to require fna based solely on the standard eus. if the aims of the study are achieved, it ill confirm that contrast-enhanced eus can be used to differentiate various pancreatic lesions and, in future, may aid in risk-stratification of precursor lesions for pancreatic cancer.

Eligibility criteria:
inclusion criteria: * patients undergoing endoscopic ultrasound for pancreatic indications * patients must have unexplained pancreatitis, pancreas mass(es), or pancreatic cystic lesions or worrisome clinical, imaging or laboratory findings exclusion criteria: * patients \<18 years of age, pregnant women, and lactating mothers will be excluded. * subjects with unstable cardiopulmonary condition will be excluded (acute myocardial infarction, acute coronary syndromes, worsening or unstable heart failure, or serious ventricular arrhythmias) * patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts will be excluded given theoretical (though clinically insignificant) risk of embolization * patients with a history of allergy to lumason will be excluded
acute lung injury after cardiac surgery: pathogenesis

Conditions: Acute Lung Injury; Metabolic Disturbances; Inflammation; Coagulation; Intravascular; Postoperative; Dysfunction Following Cardiac Surgery

Summary: the purpose of the present study is to visualize the inflammatory response and coagulation disorders during cardiac surgery in order to identify possible predictors for acute lung injury postoperatively.

acute lung injury after cardiac surgery is a common complication. the pathophysiology is complex and still not fully elucidate. no specific biomarkers are identified and the diagnosis is solely based on impaired oxygenation. the purpose of the present study is to identify biomarkers of inflammation and coagulation in blood withdrawn simultaneous from the pulmonary artery and the left atrium during surgery and up to 20 hours after weaning from cardiopulmonary bypass.

Eligibility criteria:
inclusion criteria: * elective surgery * cabg * in treatment with statins exclusion criteria: * acute surgery * valve replacement * in treatment with immunodepressive drugs
metabolomic study of all-age cardiomyopathy

Conditions: Dilated Cardiomyopathy; Hypertrophic Cardiomyopathy; Arrhythmogenic Right Ventricular Cardiomyopathy; Left Ventricular Non-compaction; Restrictive Cardiomyopathy

Summary: this study aims to 1)characterize the differentially expressed metabolites between cardiomyopathy patients and healthy controls,2)identify the specific biomarkers associated with outcomes or risk evaluation in patients with different cardiomyopathies in a follow-up of a cohort and 3)to determine whether differentially expressed may affect the pathological process of cardiomyopathies . standardized protocols will be used for the assessment of medical history and examinations, laboratory biomarkers, and the collection of blood plasma.

the aim of this study is to analyze metabolomic profile of patients with cardiomyopathy in order to identify biochemical markers with risk stratification and prognostic value. clinical data of enrolled patients regarding demographics, cardiovascular risk factors，clinical lab data and previous cardiovascular disease will be recorded. follow up will be at 3 months,6 months,9 months,1 year and 3 years and will be performed by clinical recordings or phone call when necessary. blood samples of patients with cardiomyopathy are taken when they enrolled. serum samples will be analyzed by liquid chromatograph mass spectrometer/mass spectrometer.

Eligibility criteria:
inclusion criteria: 1. subjects who was diagnosed as cardiomyopathy by medical history, clinical symptoms, laboratory tests including ecg, echocardiography. 2. subject understands study requirements aand agrees to sign an informed consent form prior to any study procedures exclusion criteria: 1. endocrine disease known to cause heart muscle disease (including infants of diabetic mothers) 2. history of rheumatic fever 3. toxic exposures known to cause heart muscle disease (anthracyclines, mediastinal radiation, iron overload or heavy metal exposure) 4. hiv infection or born to an hiv positive mother 5. kawasaki disease 6. immunologic disease 7. uremia, active or chronic 8. abnormal ventricular size or function that can be attributed to intense 9.physical training or chronic anemia 10.chronic arrhythmia, unless there are studies documenting inclusion criteria prior to the onset of arrhythmia (except a patient with chronic arrhythmia, subsequently ablated, whose cardiomyopathy persists after two months is not to be excluded) 11.malignancy 12.pulmonary parenchymal or vascular disease (e.g., cystic fibrosis, cor pulmonale, or pulmonary hypertension) 13.ischemic coronary vascular disease 14.association with drugs (e.g., growth hormone, corticosteroids, cocaine) or other diseases known to cause hypertrophy