Kornimate/medical-research-clean huggingface dataset:
guerbet liver fibrosis

Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease

Summary: the goal of this study is to assess the value of liver dynamic contrast-enhanced magnetic resonance imaging (dce-mri) and texture analysis post gadopiclenol for liver fibrosis staging, in comparison with mr elastography, t1 mapping, ultrasound elastography and blood tests in 50 initial patients with metabolic dysfunction-associated steatohepatitis (mash).

metabolic dysfunction-associated steatotic liver disease (masld, formerly known as nonalcoholic fatty liver disease or nafld) is characterized by the accumulation of excess fat in the liver, ranging from mild forms like non-alcoholic fatty liver (nafl) to more severe stages such as metabolic dysfunction-associated steatohepatitis (mash, formerly known as nonalcoholic steatohepatitis or nash) with associated inflammation, ballooning, fibrosis, and cirrhosis. the severity of mash and increasing fibrosis stages is associated with higher morbidity and mortality rates. the study will compare dynamic contrast-enhanced (dce)-mri measurements of perfusion using gadopiclenol for diagnosis of liver fibrosis to mr elastography and transient elastography, t1 mapping, ultrasound elastography and blood tests, using histopathology as the reference in patients with mash. in this study, the value of dce-mri and texture analysis using gadopiclenol, a new macrocyclic, non-ionic, extracellular contrast agent with high relaxivity will also be assessed which provides, at a lower dose, better contrast-to-noise ratio than gadoterate, gadobenate, and gadobutrol.

Eligibility criteria:
inclusion criteria: * patients with suspected masld (f0-f4) with clinically indicated percutaneous or transjugular liver biopsy within 6 months of mri (before or after mri). * both genders. * age \> 18 years. * any racial/ethnic background. exclusion criteria: * previous history or current diagnosis of hcc or decompensation. * contraindications for mri, including * medically unstable * intracranial clips * metal implants * suspected or confirmed metal in eyes * cardiac pacemaker, implanted defibrillator, other implanted electronic device * pregnancy: pregnancy tests will be offered to women of childbearing age at no cost * severe claustrophobia
this study intends to describe the characteristics of patients given the pfizer-biontech bivalent mrna covid-19 vaccine and any commercially available influenza vaccines at the same time versus at different times.

Conditions: Influenza, Human; COVID-19

Summary: this study intends to describe the characteristics of patients given the pfizer-biontech bivalent mrna covid-19 vaccine and any commercially available influenza vaccines at the same time versus at different times.


Eligibility criteria:
inclusion criteria: * enrolled in optum claims database as of 31 august 2022 (date bivalent authorized). * has a pfizer-biontech mrna bivalent covid-19 or influenza vaccine (any type) between 31 august 2022 and 30 january 2023 (earliest vaccine is index date). * aged \>=18 years on the index date * 365 days of continuous enrolment prior to index date exclusion criteria: * patients with a second dose of any type of bivalent mrna covid-19 or flu vaccine, disenrolled or died within 14 days following the first dose. * has prior covid-19 diagnosis (u07.1, any setting, any position) within 90 days (per cdc guidance on length of time before receiving a vaccine) before and on index. * has influenza vaccine between 01 august -30 august 2022 (before study period). * has a covid-19 or influenza diagnosis code in any setting within 14 days after index vaccination (excluded from all cohorts).
complicated infections in otorhinolaryngology

Conditions: Sinusitis; Otitis; Laryngitis; Lymphadenitis; Quinsy; Peritonsillar Abscess; Parapharyngeal Abscess; Preseptal Cellulitis; Subperiosteal Abscess; Orbital Abscess; Epiglottitis

Summary: this observational study aims to learn more about complicated infections treated by otorhinolaryngologists. the main questions to answer are: * what is the management of complicated sinonasal infections in ljubljana, slovenia, * what is the management of complicated ear and temporal bone infections in ljubljana, slovenia, * what is the management of complicated neck soft tissue infections in ljubljana, slovenia, * what is the management of complicated laryngeal infections in ljubljana, slovenia participants will receive standard treatment according to the established evidence-based clinical practice.

the main purpose of the research is to obtain own data on the treatment of patients with infections in ent areas that require targeted treatment by an otolaryngologist at the hospital level. based on these results, treatment outcome would be improved and hospitalization time would be shortened. we would establish clinical pathways for the treatment of these diseases in slovenia. there is still no data on the treatment of these diseases in ent departments in slovenia, so one of the main purposes of the research is to obtain objective indicators of the success of treatment in comparison with other countries and a rough epidemiological assessment of the disease in slovenia. the research would establish a database of patients with complicated infections in ent areas at the university clinical center ljubljana, which would be used for prospective analysis even after the research was completed. the register would also enable transparency in the treatment of these patients in the future. the main questions to answer are: * what is the management of complicated sinonasal infections in ljubljana, slovenia, * what is the management of complicated ear and temporal bone infections in ljubljana, slovenia, * what is the management of complicated neck soft tissue infections in ljubljana, slovenia, * what is the management of complicated laryngeal infections in ljubljana, slovenia participants will receive standard treatment according to the established evidence-based clinical practice.

Eligibility criteria:
inclusion criteria: * diagnoses: rhinitis and/or sinusitis and/or facial cellulitis and/or facial abscess and/or nasal furuncle and/or infection of the outer and/or middle and/or inner ear and/or temporal bone and/or infection of the soft tissues of the neck with/without bone and cartilage involvement and/or laryngitis and/or epiglottitis (or supraglottitis) and/or * complication of inflammation of the nose and paranasal cavities and/or ear and/or temporal bone and/or: * treated at the department of otorhinolaryngology and cervicofacial surgery, university medical center ljubljana. exclusion criteria: * disagreement of the patient and/or parents (or legal guardians) with inclusion in the research, * failure to meet the inclusion criteria.
the assessment of fatigue and quality of life in patients with bone tumor,

Conditions: Fatigue Syndrome, Chronic; Bone Tumor; Quality of Life

Summary: the aim of the present observational study is to evaluate and describe the evolution over time of the fatigue and the quality of life of patients with bone tumor, in rizzoli orthopedic institute, chemotherapy ward, during the chemotherapy treatment and in the first phase of follow-up and to identify possible prognostic factors. such knowledge is a necessary precondition for identifying patients and the periods most at risk due to the onset of fatigue, so as to be able to hypothesize adequate containment strategies.

fatigue syndrome it is a clinical condition, linked to the oncological pathology, extremely widespread and in patients undergoing chemotherapy and / or radiotherapy it is common in 80% of patients. literature stress the need for systematic studies in cancer populations with different types of cancer and at different stages of the disease using patient-oriented fatigue assessment tools. the brief fatigue inventory (bfi) is one of the scales used precisely in the evaluation of this syndrome and has proved to be a reliable and easy to use tool, also validated in italian. several authors have also shown that reduced physical activity and a worse quality of life are associated with fatigue, particularly in young patients.several authors describe the experience of 11 new sarcoma patients undergoing chemotherapy treatment. fatigue had been described as the prevalent symptom and was related to a worse quality of life.

Eligibility criteria:
inclusion criteria: * patients diagnosed with bone tumors who start a new chemotherapy treatment protocol exclusion criteria: * patients with little knowledge of the italian language
the effects of potassium nitrate in reducing dentinal hypersensitivity

Conditions: Dentinal Hypersensitivity; Dental Pain

Summary: a randomized, controlled, double blind exploratory study to explore the effects of two different potassium nitrate concentrations and water on exposed dentine in reducing dentinal hypersensitivity. solutions will be applied for either 2, 5 or 10 minutes and assessed by visual analogue scale (vas) scores following evaporative (air) stimulus.


Eligibility criteria:
inclusion criteria: * general health and oral heath: good general health and oral health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history. * teeth: presence of teeth in various locations in the mouth to determine stent success. required teeth include: at least three first molars; a maxillary incisor, cuspid and bicuspid; and a mandibular incisor, cuspid and bicuspid. * dental sensitivity: a) self-reported history of dentinal hypersensitivity lasting more than 6 months and a primary complaint of sensitive teeth. b) a minimum of three accessible teeth that can be isolated that meet all of the following criteria at the screening visit: i. teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. study teeth must exhibit greater than or equal to 3mm recession at the facial surface midpoint. ii. teeth must be visually stain and calculus free. iii. teeth having a gingival index score less than or equal to 2. iv. teeth with a clinical mobility of less than or equal to 1. v. teeth that show signs of sensitivity, evaporative (air) sensitive teeth displaying a response of greater than or equal to 30 mm on a 100 mm visual analogue scale (vas). c) a minimum of three eligible teeth identified at the screening visit that continue to show signs of sensitivity at the baseline assessment at treatment visit 1, evaporative (air) sensitive teeth displaying a response of greater than or equal to 30 mm on a 100 mm vas. exclusion criteria: * allergy/intolerance: known or suspected intolerance or hypersensitivity to the stent materials (or closely related compounds) or any of their stated ingredients. * condition of the dentition: a) sensitive teeth not expected to respond to treatment with an over-the-counter (otc) dentifrice in the opinion of the investigator. b) teeth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns, orthodontic bands, extensive caries or cracked enamel. sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine.

Keywords: dentinal sensitivity potassium nitrate dental pain
implantable loop recorder in hemodialysis patients

Conditions: Hemodialysis; Cardiac Arrhythmia; Cardiac Death

Summary: the purpose of this study is to use implantable loop recorder (ilr) in patients under chronic hemodialysis to record arrhythmias and conduction disorders and correlate them with hemodialysis parameters.

primary cause of death in patients under chronic hemodialysis is sudden cardiac death (scd) (25% of all cause mortality). scd is mainly due to cardiac arrhythmias (conduction disturbances or ventricular arrhythmias). these cardiac arrhythmias are highly sensitive to hydro-electrolytic disorders which are extremely frequent in patients under hemodialysis. in addition, other conditions leading to cardiac arrhythmias are frequent in this population such as ischemic myocardiopathy or dilated myocardiopathy. however, so far, little is known about the occurrence of arrhythmias because of studies using only standard holter monitoring (24 to 48 hours monitoring at best). the investigators sought to evaluate the incidence of cardiac arrhythmias by using an implantable loop recorder (ilr)(reveal xt, medtronic) that allows continuous rhythm monitoring for 24 months. this ilr will be implanted under local anesthesia. clinical follow-up will be performed during hemodialysis and rhythm management will be performed automatically using a remote-monitoring system (carelink, medtronic). pre-programmed alerts (conduction disturbances, supra-ventricular arrhythmias or ventricular arrhythmias) recorded by the ilr will be sent automatically on a daily basis in our center. these data will be analyzed during week days from 9am to 5pm. they will be reviewed by an electrophysiologists and depending on the potential lethality, the patients will be called and ask to come to the emergency room in case of high risk or the nephrologist will be contacted and he will see the patients during the next hemodialysis in case of on vital event.

Eligibility criteria:
inclusion criteria: * patients under chronic hemodialysis * age between 45 and 80 yo * written informed consent * affiliated to the french social security system exclusion criteria: * pace-maker or implantable cardioverter defibrillator * active infection * neoplasia or any pathology with a life expectancy \<12 months * cachexia * patient with restricted civic rights by law

Keywords: hemodialysis cardiac arrhythmia cardiac death implantable loop recorder
a study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab in participants with thyroid eye disease

Conditions: Thyroid Eye Disease; TED

Summary: the purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of subcutaneous (sc) satralizumab, a recombinant, humanized anti-interleukin-6 (il-6) receptor monoclonal antibody, in participants with thyroid eye disease (ted).


Eligibility criteria:
inclusion criteria: - clinical diagnosis of ted based on cas exclusion criteria: * decrease in cas or proptosis of \>= 2 points or \>= 2 mm, respectively, in the study eye between screening and study baseline (day 1) * requiring immediate surgical ophthalmological intervention or planning corrective surgery or irradiation during the course of the study, in the judgment of the investigator * identified pre-existing ophthalmic disease that, in the judgment of the investigator, would preclude study participation or complicate interpretation of study results, including corneal decompensation unresponsive to medical management and including ophthalmic diseases that will likely require prohibited therapy during the study * any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study * pregnant or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of satralizumab
personalized nutrition advice for optimizing dietary calcium intake in ms patients

Conditions: Multiple Sclerosis

Summary: the main objective of this study is to measure effectiveness at 6 months of personalized dietary advice versus dietary counseling via delivery of a standard advice sheet for optimizing dietary calcium intake (assessed by a food survey based on ciqual\* data) in ms patients with ambulatory monitoring. \*ciqual data: table of nutritional food composition available on the anses (national agency for sanitary security of food, environment and labour) website, published by the observatory of the nutritional quality of foods. this table includes 1,500 sheets of 58 nutritional components. the data is integrated into the software for calculating ingesta (datameal) at the nîmes university hospital.

the secondary objectives of this study is to compare the two groups in order to: a- correlate the impact of the recommendations by sheet or consult with disability, cognitive status, fatigue, depression, quality of life of patients with ms. b- assess the prevalence of diet changes as an alternative therapy for lactose intolerance in the population and to correlate these changes with dietary calcium intake at baseline (assessed by a food survey based on ciqual\* data). c- assess calcium intake of the patients included via the self-administered frequency questionnaire qalcimum® on day 0 and 6 months and to compare them with data obtained by the food survey based on data from ciqual. d- correlate calcium intake of the patients with vitamin d levels at inclusion and establish a biological collection of blood samples from the population.

Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * patient with a confirmed diagnosis of remitting multiple sclerosis * ambulatory patient (edss score \< 6.5) who has never had a dietary consultation concerning the optimization of calcium intake exclusion criteria: * the patient is participating in another non-observational study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the subject is not able to complete a self-administered questionnaire * vitamin d deficiency linked to currently active digestive or general diseases * moderate or severe renal impairment (creatinine clearance \<60ml / min) * situations accompanied by increased vulnerability to hypercalcemia, eg arrhythmia or known heart disease, treatment with digitalis, subjects with nephrolithiasis
neutrophil gelatinase-associated lipocalin (ngal) rapid test (colloidal gold) clinical trial protocol

Conditions: Peritoneal Dialysis-associated Peritonitis

Summary: according to the requirements of the "technical guidelines for clinical trials of in vitro diagnostic reagents", the first registered product (hereinafter referred to as the assessment reagent) - neutrophil gelatinase-associated lipocalin (ngal) rapid test (colloidal gold) was tested in clinical institutions. ) for clinical validation trials. prove that the clinical performance of the assessment reagent meets the requirements of the intended use.


Eligibility criteria:
inclusion criteria: patients treated with peritoneal dialysis due to kidney disease, including those with confirmed peritonitis and those without peritonitis. there are no age or gender requirements, and informed consent is required. exclusion criteria: 1. patients who have been treated with antibiotics for peritonitis before taking the sample. 2. incomplete information, including: sample id number, gender, age, department, clinical diagnosis, sample type, and sampling date. 3. the sample size is insufficient. 4. repeated cases. 5. the samples whose permeate is red in visual inspection.
targeting microvascular dysfunction in young hypertensive patients

Conditions: Hypertension

Summary: cholesterol and blood pressure lowering tablets have been shown to be of benefit in patients with established high blood pressure. high blood pressure is a very common medical condition that can lead to vascular complications i.e. problems with the blood vessels in the body. one way of detecting early changes in these blood vessels as a result of high blood pressure is to measure their compliance/flexibility with a noninvasive technique known as ultrasound and with a simple blood test. the investigators are trying to establish whether these early changes in blood vessels can be significantly improved by the use of both a cholesterol and blood pressure lowering tablet at an earlier stage than is currently advised. the investigators hope that the early combination of these tablets will prove more effective than the use of a blood pressure lowering tablet by itself and therefore possibly reduce the risk of long term complications developing.


Eligibility criteria:
inclusion criteria: * to be eligible for the study, all of the following criteria must be met: * all patients must have a diagnosis of essential hypertension with off treatment systolic pressure \>140 mmhg and/or diastolic pressure \>90 mmhg, measured at rest in the seated position on at least two separate occasions, at least 2 weeks apart. * patients will be \< 50 years for men and \< 60 years for women. * female patients of childbearing potential must be using a medically accepted means of contraception (that is, interuterine device, oral contraceptive, implant, depoprovera or barrier devices). female patients of childbearing age will be screened with a pregnancy test. * patients will be typically already on antihypertensive therapy. * patients must have a level of understanding sufficient to complete all tests and examinations required by the protocol and are able to understand and give informed consent. exclusion criteria: * patients will be excluded from the study if they meet any of the following criteria: * a history of diabetes mellitus, coronary artery or cerebrovascular disease, hypertensive retinopathy, hypertensive nephropathy, left ventricular hypertrophy or hyperlipidaemia warranting treatment as defined by the latest nice guidelines which recommend an age based treatment strategy rather than one driven purely by lipid levels in isolation. * abnormal baseline liver function (defined as ast or alt \> 3 times upper limit of normal), raised baseline creatinine kinase (ck) (defined as ck \> 200 mmol/l), severe renal impairment (defined as estimated glomerular filtration rate (egfr) \< 30 mls/minute) or previous adverse event relating to either an arb or statin in the past. * female patients will be excluded if they are pregnant, intend to be pregnant or are lactating. female patients of childbearing age will be screened with a pregnancy test.

Keywords: hypertension endothelial dysfunction statin prevention
mguard™ prime embolic protection stent in patients with acute st elevation myocardial infarction

Conditions: ST Elevation Myocardial Infarction

Summary: prospective, non-randomized, single arm, multicenter observational study. the objective is to evaluate the safety and efficacy of the mguard™ prime stent in the treatment of de novo stenotic lesions in coronary arteries in patients undergoing primary percutaneous coronary intervention (pci) due to acute st elevation myocardial infarction (stemi) in a real-world setting.


Eligibility criteria:
inclusion criteria: 1. subject is \>18 years of age. 2. subject is experiencing clinical symptoms consistent with st elevation acute myocardial infarction (stemi) of \>30 minutes and \<24 hours. 3. based on coronary anatomy, primary pci is indicated for the culprit lesion with anticipated use of stenting. 4. subject agrees to all required follow-up procedures and visits and has provided informed consent where required. 5. the target lesion is a de novo lesion in a native coronary artery. 6. the reference vessel diameter (rvd) of the infarct lesion is 2.75-4.0 mm by visual assessment. exclusion criteria: 1. subject undergoing cardiopulmonary resuscitation. 2. cardiogenic shock (sbp \ 30 minutes, or requiring iv pressors or intra-aortic balloon bump (iabp) or other hemodynamic support device for hypotension). 3. co-morbid condition(s) or others that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial. 4. target lesion involves a bifurcation with a side branch \>/=2.0 mm in diameter. 5. in the investigator's opinion the lesion/vessel is unsuitable for treatment with the mguard™ prime embolic protection stent system for any reason.

Keywords: stemi heart attack stent bare metal stent myocardial infarction pci