Amravati, India
The Next Step Towards the Elimination of Iodine Deficiency and Preventable Iodine-related Disorders in Europe
Detailed Description: BACKGROUND: Iodine deficiency (ID) is a leading risk factor for thyroid disorders and developmental impairments in offspring. It is recognized as one of the most preventable causes of mental impairment in children. The EUthyroid2 project aims to contribute to the prevention of ID and its associated symptoms and disease burden in adolescents across Europe and beyond. AIM: This project seeks to develop and implement an educational intervention in various educational settings, effectively raising awareness of the risks associated with iodine deficiency. METHODS: The intervention will be conducted in each participating country, with three clusters (secondary schools, high schools, and vocational schools) per country. The goal is to achieve a final sample of 4500 study participants in all countries combined, involving one baseline measurement and two follow-up assessments (2-4 weeks and 6-8 months post-intervention). Data will be collected at all measurement points, with variations in implementation accounted for due to differences between countries. To ensure the intervention's functionality and effectiveness, the project will consider recommendations for developing complex interventions, appropriate theoretical frameworks, and conduct a context analysis. Outcome measures will include a newly developed iodine awareness questionnaire (primary outcome) and an iodine-specific food frequency questionnaire. Additionally, socio-demographic characteristics will be measured. Descriptive analyses will be performed on all variables, with subgroup and country-specific analyses computed. A process evaluation will assess the implementation process using a convergent parallel mixed methods design, inviting teachers and students to participate in an online questionnaire. Semi-structured interviews will further enrich this evaluation. CONCLUSION/OUTLOOK: The results of the EUthyroid2 project may assist health authorities across participating countries in implementing effective strategies to reduce iodine deficiency and its associated risks. Ultimately, this could lead to a sustainable decrease in the disease burden induced by iodine deficiency.
Phase
N/ASpan
53 weeksSponsor
EUthyroidLjubljana
Recruiting
Healthy Volunteers
Flash Glucose Monitoring Targets in Gestational Diabetes
Phase
N/ASpan
157 weeksSponsor
University Medical Centre LjubljanaLjubljana
Recruiting
Electrolysed Saline Rinse As an Adjunct for Treatment of Chronic Periodontitis
Before enrolment in the study, we will perform a thorough clinical examination of each patient, which will involve assessing several periodontal parameters at six sites around each tooth on all teeth, excluding third molars: plaque index (PlI), probing depth (PD), gingival recession (GR), clinical attachment loss (CAL), bleeding on probing (BOP), furcation involvement, and tooth mobility. All clinical parameters will be measured using a William's periodontal probe (Hu-Friedy, USA, PQW6). Local X-rays of sites affected by periodontitis will be taken. The performed clinical examination will not differ in any way from the examination conducted on all patients, even those not included in our study. The population of included subjects will consist of individuals of both sexes, aged 25-70 years, smokers and non-smokers, with moderate or advanced stage of chronic periodontitis (stage III, IV). They will be selected based on the following inclusion criteria: clinical attachment loss ≥ 5 mm on at least two teeth in two different jaw quadrants; presence of stable occlusion and at least 16 teeth, among which at least 12 teeth are suitable for evaluation (excluding wisdom teeth, teeth with orthodontic wires, bridges, crowns, and implants). We will exclude individuals who: suffer from chronic systemic diseases (diabetes, cancer, HIV infection, metabolic bone diseases, and diseases that interfere with wound healing processes); are undergoing radiation or chemotherapy; are taking immunosuppressants, antiepileptic drugs, calcium antagonists, nonsteroidal anti-inflammatory drugs; have been treated with antibiotics in the past 12 months; have a known allergy to CHX; have undergone scaling and root planing or surgical periodontal treatment in the past year; are pregnant or breastfeeding. Patients will be informed about the purpose of the research in writing. Prior to the commencement of the study, all patients will fill out an informed consent form. Subjects will then be divided into three groups of 20; the first group will use a mouthwash consisting of EOS (active ingredient) for one month after the non-surgical treatment; the second group will use a mouthwash containing CHX (positive control); and the third group will use distilled water (negative control/placebo). Randomization will be performed using a computer program. Only one member of the research group, who will also prepare the mouthwashes, will know the content of the randomization table or the type of mouthwash used by each individual. Identification codes will remain hidden from all other researchers and subjects until the final follow-up examinations. The packaging of the mouthwashes will be identical, and the active ingredients will not be distinguishable by color. Samples of subgingival fluid will be collected at the beginning of the test period for the purpose of microbiological characterization using sterile paper points from the buccal surface of four teeth (sites with the greatest probing depths in each quadrant) and transported to the laboratory of the Institute of Microbiology and Immunology using a transport medium (RTF). The microbiological analysis will be performed using Quantitative Polymerase Chain Reaction (qPCR). Subsequently, all patients will undergo a non-surgical periodontal treatment, which will include instruction and motivation for proper oral hygiene, removal of hard and soft plaque deposits using a piezoelectric device and ultrasonic tip, and root planing and scaling under local anesthesia. Each subject will then receive a package with an identification number and the label A, B, or C on it, according to the computer-generated randomization scheme. One-third of the patients will receive EOS in the package, one-third will receive CHX, and one-third will receive distilled water. Subjects will then rinse their oral cavities with 15 ml of their allocated mouthwash twice daily (in the morning and evening) for 30 seconds for four consecutive weeks. After four weeks, subjects will be invited for their first follow-up examination. They will report any side effects and return the packaging of the for compliance control. They will also be asked about the organoleptic properties of the mouthwash they used. We will perform a thorough clinical examination again and collect samples of subgingival fluid in the same manner as during the initial examination. The second follow-up examination will be conducted three months after the oral hygiene phase and will include a clinical assessment and collection of subgingival fluid samples. The primary outcome variable will be the number of residual diseased sites (PD > 4mm + BOP). Secondary outcome variables will include plaque index assessment, BOP, PD, and quantity of periodontopathogens. Since teeth are "nested" within patients and probing sites are "nested" within teeth, the collected data is interdependent. A multilevel multiple logistic regression model will therefore be used to examine associations between variables.
Phase
N/ASpan
131 weeksSponsor
University of LjubljanaLjubljana
Recruiting
Evaluation of Physical Fitness and Hemodynamics Across a Diverse Population
Study description This study is a work package of the ACT-ON project, aimed at validating different physical fitness assessment tests in diverse populations considering their health status. Thus, in the proposed study we will assess the potential for validating a selected cardiovascular function test for individuals with varying levels of physical fitness. The chosen test, the Intermittent Fitness Test 30-15 (hereafter referred to as IFT 30-15), is a field test commonly used to measure or determine aerobic capacities. More specifically, IFT 30-15 allows for the assessment of maximum oxygen uptake (VO2max), maximum heart rate (HRmax), as well as anaerobic capacity and capacity for intermittent high-intensity running. Of particular importance to us is the test's high potential to determine VO2max and HRmax, which consequently allows for defining workloads in specific training zones. To collect the necessary data, the investigators will use a range of instruments and tools in all planned studies in the following order: Upon arrival at the laboratory of the Institute of Sport at the Faculty of Sport, the investigators will measure participants' basic anthropometric characteristics and body composition. the investigators will use a stadiometer and anthropometer (GPM, Model 101, Switzerland) to measure height, and body mass will be measured using a multi-frequency bioelectrical impedance device (InBody 720: Biospace, Korea). Blood pressure will then be measured using the Omron M6 device. Hemodynamics Pulse Wave Velocity (PWV) Characteristics The Vicorder device (software version 4; Skidmore Medical, United Kingdom) will be used to measure pulse wave characteristics (PWA) of the brachial artery and pulse wave velocity from the carotid to the femoral artery (cfPWV). This device uses an oscillometric technique to obtain the pulse wave. cfPWV measurements will be taken using a 10 cm cuff around the upper right thigh to detect the femoral pulse and a 3 cm cuff around the neck to detect the right carotid pulse. The neck cuff is designed to be positioned above one carotid artery, avoiding compression of the trachea and both carotid arteries simultaneously. The distance between the suprasternal notch and the cuff on the upper thigh will be measured according to the manufacturer's instructions. Both cuffs will automatically inflate simultaneously to 65 mmHg, with pulse waves recorded in 3 to 5-second intervals while the participant lies in a supine position. Flow-Mediated Slowing (FMS) The VICORDER® EndoCheck FMS model was used for FMS determination. Testing was conducted following the device instructions. The pulse wave velocity (PWV) on the upper arm was measured simultaneously between the wrist and upper part of the right arm over 10 minutes, with a 5-minute flow occlusion period. FMS was determined by continuously measuring the minimal PWV compared to the baseline PWV, with the percentage change designated as FMS. Physical Performance Maximal Aerobic Capacity Equipment for Testing Maximal Aerobic Capacity To obtain physiological parameters, the investigators will use a portable gas analyzer K5 (COSMED, Italy). The device provides reliable values for oxygen uptake (VO2), carbon dioxide production (VCO2), and pulmonary ventilation (VE) on a breath-by-breath basis. Heart rate will simultaneously be measured with a heart rate monitor chest strap (Polar, model H10, Finland). Data will be recorded in 5-second intervals and automatically analyzed using the original Polar software. Similar methods were used in previous studies. Incremental Treadmill Test After 5 minutes of baseline measurements while participants stand on the treadmill (HP Cosmos, Germany), participants will warm up at a running speed of 8 km/h and a constant 1% incline. They will then perform the actual test, running to exhaustion while the running speed gradually increases by 2 km/h each minute. VO2peak will be defined as a plateau in VO2 values (decrease < 2.1 ml/kg/min) despite an increase in workload. If this criterion is not met, participants will undergo an additional test at a constant speed equal to or greater than the maximum speed reached at the end of the incremental test, as recommended. Respiratory gases will be continuously measured for each breath during the test and averaged over 10-second intervals. Similar methods were used in previous studies. 30-15 Incremental Fitness Test (30-15IFT) The 30-15 Incremental Fitness Test (30-15IFT) will be used as a field tool to assess cardiovascular endurance (CRF). This intermittent, incremental test consists of 30-second runs on the spot, followed by 15-second active recovery periods. Running speed will be set at 8 km/h for the first 30-second interval and then increase by 0.5 km/h for each subsequent 30-second interval. Participants will be required to run back and forth between two lines spaced 40 m apart, at a predefined pace determined by a pre-recorded signal. This signal allows participants to adjust their running speed as they enter a 3-meter zone in the middle and at each end of the test field. During the 15-second recovery periods, participants will walk to the nearest line (either in the middle or at the end of the running area, depending on where they finished the previous run), and start the next running phase from this line. Participants will be encouraged to complete as many stages as possible. The test will conclude when the participant can no longer maintain the required running speed or if they fail to reach the 3-meter zone three consecutive times before the beep. The speed of the last successfully completed stage will be recorded as the test result, i.e., the minimal running speed (MRS) during the 30-15IFT (MRS IFT). Similar methods were used in previous studies. Maximal Aerobic Capacity (VO2max) Using the IFT 30-15 Test The investigators will measure or determine VO2max indirectly using the following formula: VO2 max (ml.kg-1.min-1) = 28.3 - (2.15 x S) - (0.741 x L) - (0.0357 x TT) + (0.0586 x L x VIFT) + (1.03 x VIFT) S = gender (male=1, female=2) L = age in years TT = body weight in kilograms VIFT = final speed achieved 6-Minute Walk Test (6MWT) The protocol for the 6-Minute Walk Test (6MWT) was developed following the American Thoracic Society guidelines (2002). The investigators will check for any contraindications among participants, then ask them to walk as far as they can without running along a 40-meter hallway. If a participant stops walking before the 6 minutes have elapsed (or if the test administrator judges that they should not continue), the reason for stopping will be recorded. Test results will be expressed as the walking distance (i.e., 6MWD) in meters. Sit-to-stand and Push-ups
Phase
N/ASpan
156 weeksSponsor
University of LjubljanaLjubljana
Recruiting
Healthy Volunteers
A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Phase
3Span
266 weeksSponsor
Janssen Research & Development, LLCLjubljana
Recruiting
Acute Effects of HIIT vs. MICT on HRV
Phase
N/ASpan
18 weeksSponsor
University Medical Centre LjubljanaLjubljana
Recruiting
Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality
The single-center, randomized, cross over, double-blind, placebo controlled intervention study will include 30 subjects who will test the efficacy of three formulations with different dosages of melatonin on sleep quality parameters.
Phase
N/ASpan
53 weeksSponsor
Nutrition Institute, SloveniaLjubljana
Recruiting
Healthy Volunteers
Molecular Biomarkers of Response to Radiation Therapy in Breast Cancer
Monocentric prospective clinical study including DCIS patients treated at the Institute of Oncology Ljubljana. Patients treated with adjuvant radiotherapy and without systemic therapy are eligible for the study. Adverse events of radiation treatment will be assessed after radiotherapy and during 5-year follow up and classified according to Common Terminology Criteria for Adverse Events v5.0. Molecular biomarkers will be assessed before radiotherapy, after radiotherapy and during follow up. DNA will be isolated from whole blood samples obtained before radiation treatment. Circulating biomarkers will be isolated from plasma samples before treatment, after treatment and during follow-up. Written informed consent will be obtained from all included patients and the study design was approved by the National Medical Ethics Committee.
Phase
N/ASpan
531 weeksSponsor
Institute of Oncology LjubljanaLjubljana
Recruiting
Usability of the Smart Hallway System in Clinical Setting
The goal of the study is to use off-the-shelves markerless and contactless technologies and automatically digitise the person's movements as they walk through an institutional hallway. Multi-camera-based technologies can merge 2D-video into 3D-information. With an appropriate software, one can acquire data, perform the kinematic calculations and generate a report, all with minimal or no human intervention. The specific research question are whether pathological gait or walking disorders of the patients can be identified and classified based on the system's output, whether signs of depression can be classified from the the system's output, and whether the results of the 6-minute walk test can be predicted from the the system's output.
Phase
N/ASpan
67 weeksSponsor
University Rehabilitation Institute, Republic of SloveniaLjubljana
Recruiting
Perceptions of RehAtt Mixed Reality System
Mixed reality is an immersive technology that can integrate virtual objects into the real world and adaptive scenarios. It offers the opportunity to train physical and cognitive aspects in stroke patients. The patients' perspectives were assessed with a semi-structured interview.
Phase
N/ASpan
34 weeksSponsor
University Rehabilitation Institute, Republic of SloveniaLjubljana
Recruiting