Clinical trials

This observational study aims to determine whether optical devices designed to slow myopia progression and/or environmental factors can prevent myopia progression in the pediatric and adolescent myopic population. The study aims to answer the following questions: 1. How does myopia progression change with age while wearing myopia progression control glasses? 2. How does myopia progression change while wearing myopia progression-control glasses when environmental factors, such as time spent outdoors and place of residence, are taken into account? 3. How does myopia progression change at different ages while wearing myopia progression control glasses given a family history of myopia? This will be a self-controlled observational study. Participants who are myopic after cycloplegic refraction will be prescribed DIMS glasses. DIMS stands for "defocus incorporated multiple segments," a specialized optical technology used in spectacle lenses to slow nearsightedness progression in children. Patients will keep a diary of their subjective symptoms and environmental factors, e.g., time spent outdoors and screen time. Patients will visit the clinic once every six months for checkups and the following tests: * Best corrected visual acuity test * Stereopsis * Automatic refractometry * Bulbar axial length measurement In a follow-up study, researchers will compare myopia progression with environmental and baseline factors to learn about the long-term effects of DIMS lenses on myopia progression.

This is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of prophylactic endoscopic sphincterotomy (ES) in frail patients unfit for cholecystectomy following an episode of acute biliary pancreatitis (ABP). Eligible patients will be randomized in a 1:1 ratio to either prophylactic ES during the index admission or conservative treatment. The primary endpoint is the time from randomization to the first occurrence of a recurrent pancreatobiliary event within 12 months, including recurrent ABP, cholangitis, choledocholithiasis requiring endoscopic retrograde cholangiopancreatography (ERCP), or cholangiogenic liver abscess. Secondary outcomes include mortality, pancreatobiliary events requiring intensive care unit admission, post-ERCP complications, cholecystitis, and length of hospitalization. A total of 92 patients will be enrolled. The trial will be led by the Institute of Pancreatic Diseases, Semmelweis University, Budapest, Hungary, and conducted in accordance with Good Clinical Practice.

The aim is to evaluate in a prospective, randomized, controlled clinical study the healing of a MIST procedure combined with PRF, or GBT combined with PRF. Clinical, radiological evaluation of the regenerative surgical method and the GBT non-surgical therapy in solitaire deep intrabony periodontal defect.

The objective of this observational study was to gain a deeper understanding of the epidemiology of the disease in Hungary through a broad analysis of patients with new-onset esophageal-oesophageal-stomach junction tumors, and to identify key parameters that could potentially influence the outcome of the disease and are closely correlated with morbidity and mortality. The investigators' primary objective is to identify potential factors and conditions that could be influenced and modified to enhance the disease outcome. Main questions: 1. What are the measurable changes in performance, workload, nutritional status, cardiac function, mental status in the patients studied? 2. What is the time course of the changes during and after treatment? 3. Which pathological parameters are associated with disease outcome and which are potential points of intervention to improve the course of the disease? Patients will undergo a detailed physical and nutritional assessment, non-invasive imaging tests and several questionnaires in addition to the usual pre- and post-operative examinations.

This is a prospective, single center, pharmacokinetic study of intravenous hydrocortisone therapy for systemic low blood pressure during hypothermia treatment in asphyxiated newborns. Patients will be allocated to hydrocortisone supplementation while receiving conventional inotropic therapy as needed. The hypothesis is that a detailed study of hydrocortisone pharmacokinetics during therapeutic hypothermia would help to personalize steroid supplementation in asphyxiated neonates. As the overall metabolic rate decreases with lower body temperature, drug metabolism is likely to be reduced as well, and lower doses, or less frequent dosing will be sufficient to achieve the targeted steroid range and biological effects in asphyxiated neonates with relative adrenal insufficiency. Thus, the investigators are planning to measure initial, baseline serum cortisol levels and serial serum cortisol levels after hydrocortisone supplementation in cooled asphyxiated neonates.

The goal of this randomized controlled trial is to evaluate whether a virtual reality based preparation method can efficiently decrease the proportion of children requiring general anesthesia during MRI examinations. Participants will take part in a virtual reality environment resembling an MRI before their scheduled MRI examination. Researchers will compare these children to usual care and a booklet based preparation method to see if less children need anesthesia for completing the MRI examination.

This study aims to assess the feasibility of the decompression of odontogenic cysts using Patient Specific Implants anchored subperiosteally using osteosynthesis screws.

Pneumatization of the maxillary sinus may lead to insufficient bone volume for dental implant placement in the edentulous posterior maxilla. Sinus floor elevation (SFE) surgery with the lateral window technique is a safe and predictable surgical intervention to restore bone height in the maxillary premolar and molar areas. According to the literature, several bone graft materials may be successfully applied for SFE surgery. There is a lack of evidence regarding the application of biphasic calcium sulfate (BCS) for SFE. The healing period following staged SFE is 2-9 months. The aim of this study is: * to evaluate the success of SFE surgery using BCS as graft material, * to compare the microarchitecture of the augmented bone depending on the healing period, * to evaluate the success of dental implants placed in the augmented bone and that of the prostheses delivered on the dental implants.

The goal of this clinical trial is to examine the success and safety of administering certain antibiotics (beta-lactams) given in a longer 3-hour infusion to children (0-17 years) who are critically ill and have severe infection. The main question it aims to answer is: Is the longer infusion more effective than the conventional short-term (0.5-hour-long) infusion? Researchers will compare the 3-hour-long infusion group to the 0.5-hour-long infusion group to determine whether the longer infusion can cure the infection earlier and whether it is equally safe. The doses are the same in the two groups. Only the duration differs until the patient receives the antibiotic. Participants will: * be given the required antibiotic drug in a 3-hour-long or in a 0.5 hour-long infusion. * be examined to make sure their blood drug levels are correct. This will require two blood tests. * be treated according to routine care and have examinations and blood tests performed.

This clinical trial aims to personalise red blood cell transfusion strategies in the crtitically ill patients. The amount of transfusions needs to be minimised in order to prevent adverse events and organ dysfunctions linked to high amounts of red blood cell transfusions. The researchers aim to investigate the efficacy and safety of measuring the central venous oxygen saturation (ScvO2) (oxygen content in a venous blood sample taken from a central line) to guide clinicians if transfusion is necessary. The researchers aim to compare the ScvO2 guided transfusion strategy with transfusion based on the clinician's judgment (taking into consideration the patients' comorbidities and actual vital parameters).

Dentists and physiotherapists have two options for treating these conditions: splint therapy and physiotherapy. Right now, the gold standard is individual physiotherapy, which contains manual therapy and active exercises too. Since not many dentists and physiotherapists are experts in this area, patients have to wait for months or even years to get their treatment. Thanks to social media, patients can find many information about their condition while they are waiting, but it's our responsibility to provide safe and effective information. In view of this situation, our aim is to find out if online or group physiotherapy is as effective as individual physiotherapy.

The aim of this study is to evaluate the effectiveness of prophylactic Negative Pressure Wound Therapy (NPWT) in patients with diabetes mellitus undergoing laparotomy who are at high risk for Surgical Site Infections (SSI). In addition to clinical efficacy, the investigators also plan a cost effectiveness analysis to assess the applicability of this relatively high-cost intervention in a domestic healthcare setting.

The objective of this study was to offer a comprehensive framework for the adaptation of speech audiometric tests into other languages. To date, this is the first universal protocol of its kind that systematically considers linguistic, phonological, and audiological aspects. The present paper provides a protocol and an example for adaptation and standardization of the Mainzer Audiometric Test for Children (MATCH) to another language.

The study aims to compare the efficacy and safety of an absolute procalcitonin (PCT) value-guided antibiotic initiation protocol and a protocol using the kinetics of PCT (the difference between the actual and the previous day value) in hemodynamically stable critically ill patients with suspected new-onset infection on admission or during ICU stay. The main question it aims to answer: * Can the investigators decrease the number of unnecessary AB therapies using the kinetics of PCT insted of using absolute PCT values? * Is it safe to use PCT kinetics together with the clinical picture to guide AB initiation? AB therapy will be initiated according to predefined PCT protocols (Kinetics and Absolute Group). After 72 hours of treatment, an independent multidisciplinary team (infectologist, microbiologist and intensivist) will decide about the necessity of the treatment with all the relevant results in hand.

After tooth loss, the alveolar ridge undergoes various modeling and remodeling processes, resulting in overall bone resorption. In case of extensive alveolar atrophy, bone volume must be restored before or during implant placement to achieve successful dental rehabilitation and maximize implant survival and success rates. One possible method for reconstructing severe bone resorption is block bone augmentation. Due to its biological properties, autologous bone is considered the "gold standard" among bone graft materials, as it possesses osteoinductive, osteoconductive, and osteogenic properties. The advantages of using allografts over autologous bone grafts include reduced postoperative morbidity, decreased surgical time, and the absence of anatomical limitations regarding the amount of bone that can be harvested. The disadvantage of allografts is the loss of viable osteogenic cells and osteoinductive factors during processing. The aim of the study is: * to compare the success of the bone augmentation surgery depending on whether freeze-dried bone allograft blocks or autologous bone blocks are used, * compare the microarchitecture of the augmented bone depending on the bone graft material applied, * to evaluate the success of dental implants placed in the augmented bone and that of the prostheses delivered on the dental implants.

The objective is to assess the prevalence of autistic traits and feeding disorders in the general population.

The goal of this ambispective cohort study is to reveal the early indicators of delayed language development in children born with hypoxic-ischemic encephalopathy (HIE). We will examine the prognostic accuracy of different biomarkers, with a special focus on the ADC values of the corpus callosum. The main questions it aims to answer are: 1. To what extent does hypoxic-ischemic encephalopathy (HIE) in infancy affect intellectual development (IQ), receptive and expressive language abilities at different levels of the language system, and memory capacities related to language development? 2. What is the relationship between early biomarkers of brain injury-such as blood gas levels, lactate, aEEG, and MRI findings (Weeke scoring system, ADC values of the corpus callosum)-and long-term cognitive developmental outcomes? 3. What is the incidence of autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) in this high-risk population of infants with HIE? 4. Is there an association between the Weeke Total Score and long-term language developmental outcomes? 5. Can restricted diffusion (ADC values) of the splenium of the corpus callosum serve as an early neuroradiological marker of developmental language disorder (DLD)? Our participants are children born between 2017 and 2023 with moderate to severe HIE, treated with therapeutic hypothermia at Semmelwies University Children's Hospital. During their first days of life, several neonatal measurements were taken (blood gas markers, aEEG etc.), and at day 4-5, they had an MRI scan of their brain. The MRI scans will be reanalyzed, using the Weeke MRI scoring system. These children underwent a neurodevelopmental follow-up at the age of 2 years and currently, they will have another follow-up at the age of 4-7 years.

Children living with chronic health conditions face a higher risk of developing cardiovascular diseases than their peers, largely due to the accelerated aging of the heart and blood vessels. Although experts recognize this elevated risk and recommend close monitoring and early intervention, the underlying mechanisms driving this phenomenon remain poorly understood. At present, no effective interventions specifically target its root causes. Recent research shows that both large blood vessels (such as the carotid artery) and small vessels (such as those in the retina) can display early signs of damage decades before clinically apparent heart or vascular disease emerges. This accelerated vascular aging can result from multiple factors - including disease-related processes such as persistent inflammation and metabolic disturbances, treatment-related effects such as chemotherapy or long-term steroid use, and lifestyle changes associated with chronic illness, such as reduced physical activity and altered eating habits. However, it is still unclear how these factors influence the development and progression of vascular changes in children as they grow. Importantly, these changes can be monitored through non-invasive methods, offering a unique opportunity to study at-risk patients many years before overt cardiovascular disease develops. Identifying these early changes may enable us to detect and track individuals at heightened risk well in advance of clinical disease. This study aims to deepen our understanding of the causes of increased cardiovascular risk in children with chronic conditions and to lay the groundwork for earlier, more targeted prevention strategies.

A subgaleal electrode-based system combined with the novel intersectional short-pulse (ISP) stimulation was developed to enable non-invasive, high-intensity neuromodulation. ISP consists of ultra-brief, distributed pulses to maximize electric field strength in target areas while minimizing adverse effects on non-target tissues. Early preclinical studies demonstrate its efficacy in disrupting pathological oscillations and reducing seizures in animal models. This study investigates how targeted electrical brain stimulation by ISP stimulation impacts brain activity in epilepsy patients. The research aims to determine if ISP stimulation delivered via electrodes placed outside and under the scalp can safely and effectively reduce seizure frequency and intensity. Participants include epilepsy patients who haven't responded adequately to medication and aren't eligible for surgery. By precisely tuning stimulation parameters and timing stimulation to specific seizure patterns detected by EEG monitoring, the study seeks to optimize this technique for therapeutic use. The goal is to establish safety and feasibility of this minimally invasive stimulation approach, as well as to achieve preliminary efficacy data thorugh the reduction of seizure durations.

The clinical and demographic characteristics of patients undergoing transcatheter aortic valve implantation (TAVI) pose unique challenges for coronary computed tomography (CT) imaging, as this patient population is mainly composed of elderly, frail individuals with severe aortic stenosis, multiple comorbidities, high prevalence of heavily calcified coronary artery disease (CAD) and revascularized coronary arteries. Such vulnerable patients could benefit from a more precise assessment and characterization of their CAD with ultra-high resolution (UHR) photon-counting detector (PCD) CT that would potentially avoid the need for pre-implantation invasive coronary angiography (ICA). This international multicenter prospective registry study aims to investigate the feasibility and diagnostic accuracy of PCD-CT in the assessment of CAD in the high-risk population of patients undergoing TAVI, as compared to ICA.

This is a prospective intervention single center study to evaluate the feasibility and safety of intranasal breast milk in hypoxic-ischaemic encephalopathic neonates receiving therapeutic hypothermia.

This prospective study aims to compare functional abnormalities detected using myocardial perfusion SPECT imaging (MPI SPECT) with the extent and severity of anatomical findings on coronary computed tomography angiography (coronary CTA). Additionally, the investigators aim to enhance the diagnostic value of MPI SPECT by quantifying myocardial blood flow and utilizing myocardial flow reserve calculated from dynamic SPECT images. 50 patients with suspected coronary artery disease are anticipated to be enrolled. Pharmacological stress and rest-phase dynamic and static MPI SPECT following an additional coronary CTA scan are to be performed. The obtained multimodality imaging data (functional and anatomical parameters) are planned to be compared and subjected to statistical analysis. The results of this study are expected to improve risk assessment for patients with moderate cardiovascular risk and enhance the diagnostic performance of MPI SPECT.

Twenty patients seeking treatment for gingival recession coverage, ranging from 20-70 years of age with multiple Miller Class I or II buccal gingival recessions (depth≥3 mm, at least 3 adjacent teeth) will be recruited for this study. Five patients within the study patient pool looking for further orthodontic or restorative treatment that requires removal of one single rooted tooth within the study site of interest will be selected for histological sample removal. All procedures performed in this study will be executed according to established routine protocols, with the exception of block biopsies of one hopeless tooth per patient (total of 5 patients) at 6 months.

Non-inflammatory recessions and Miller class I-II-III. mucogingival defects after elimination of localized gingival enlargements are frequently encountered challenges in the daily practice. In Miller class II-III. recessions the lack of keratinized tissues often compromise the maintenance a proper oral hygiene, this can cause inflammation, which can result in further periodontal attachment loss. In the literature there are some approaches that aim at widening of keratinized tissues and root coverage at the same time, such as the subperiosteal envelope technique (SET) (Allen 1994) combined with a subepithelial connective tissue graft (SCTG) or a partially epithelialized connective tissue graft (PE-SCTG) (Stimmelmayr 2011). In the eradication of localized gingival enlargement postoperative complications following surgical removal, such as recurrence and subsequent gingival recessions as well as loss of keratinized tissues are commonly observed. Nevertheless, a state of the art comprehensive treatment approach has not been reported yet to overcome the above mentioned sequels. The aim of this study is to present a periodontal plastic surgical approach to definitively eliminate localized gingiva enlargements and to simultaneously correct consecutive Miller class I II-III. recessions, esthetic disturbances. (Ethical committee permission number: SE RKEB: 185/2020.)

The goal of the study is data collection on available fixed and personal assets required for Patient Blood Management (elements of the 3 pillars of PBM) in Central Eastern Europe countries hospitals, status before and after PBM training.