Tirane

Researchers are evaluating the safety and effectiveness of low-dose atropine eye drops (0.025% and 0.05%) in slowing the progression of myopia, a common vision disorder that worsens during childhood and adolescence. This phase III, multicenter, randomized, double-blind, placebo-controlled study involves children and adolescents aged 3 to under 18 years from 11 centers across Italy, Spain, Poland, the UK, and Albania. Progressive myopia mainly affects young people and can impact quality of life and socio-economic factors. Participants with myopia will be randomly assigned to receive either 0.025% atropine, 0.05% atropine, or placebo eye drops, administered as one drop in each eye once daily before bedtime for 24 months. An "early escape" phase allows patients on placebo who worsen after six months to switch to active treatment in an open-label format. The study includes an interim analysis after one year with adaptive design features to adjust treatment groups based on ongoing results, possibly stopping ineffective arms or re-estimating sample sizes. During the study, participants will undergo regular eye exams including refraction tests, pupil measurements, intraocular pressure checks, and ocular biometry. Questionnaires on visual sensitivity and eyeglass use will be collected. Safety monitoring involves pregnancy tests for females of childbearing potential and tracking adverse events. The primary outcome is the average yearly progression rate of myopia over 24 months. No follow-up visits are planned after the study concludes.

Researchers are investigating the effect of MI Paste Plus on reducing Streptococcus mutans bacteria and preventing white spot lesions (WSLs) in people undergoing fixed orthodontic treatment. Fixed dental braces can increase plaque buildup and bacterial growth, especially of S. mutans, which leads to enamel damage and early signs of tooth decay called white spot lesions. This study is part of a doctoral research project conducted at Universidad Cardenal Herrera CEU, Spain, aiming to determine if MI Paste Plus can help reduce these risks during orthodontic care. The study is a triple-blind, randomized clinical trial involving 200 participants aged 5 to 45 starting fixed orthodontic treatment. Participants will be divided into two groups: one applying MI Paste Plus, a topical cream containing 10% CPP-ACP and 0.20% sodium fluoride, once nightly after brushing for three months, and a control group applying a placebo gel with the same appearance and texture. Both groups will continue regular toothbrushing with fluoridated toothpaste. Treatment adherence will be tracked by daily logs and weighing returned containers. Participants will be assessed at the start, one month, and three months for salivary S. mutans levels and white spot lesion development using clinical examination and specialized imaging (ICDAS and QRay Cam Pro). Saliva samples will be collected and cultured to quantify bacterial counts. The study will also track oral hygiene status and appliance types to understand their influence. Data will be analyzed to evaluate changes in bacterial levels and lesion formation, ensuring participant safety and confidentiality throughout the study period.

Researchers are evaluating the pharmacokinetic profile of naldemedine and its active metabolite nor-naldemedine after a single oral dose in pediatric patients who are receiving or about to receive opioid treatment. The study focuses on children aged 2 to 18 years with opioid-induced constipation or at risk of developing constipation. This Phase 1/2 open-label study aims to assess how the drug behaves in the body, including its absorption, metabolism, and clearance. Participants receive naldemedine either as an oral tablet (0.2 mg dose) or as an oral suspension at various dose levels. The study involves monitoring drug levels in the blood at specific time points after dosing, including several samples on Day 1, a sample before the Day 2 dose, and additional sampling on Day 7 for some participants. These measures help evaluate the drug's maximum concentration, time to reach maximum concentration, total exposure over time, elimination rate, half-life, clearance, and volume of distribution. During the study, participants will remain in the clinic for blood sampling for at least 12 hours after the first dose and return for a 24-hour post-dose sample. Researchers will measure detailed pharmacokinetic parameters to understand the drug's safety, tolerability, and behavior in the pediatric population receiving opioids. The study includes careful monitoring of participants' health and response during the study period, with a focus on children with cancer or non-cancer pain treated with opioids.

Researchers are evaluating the effectiveness and safety of an intravenous human plasma-derived C1 esterase inhibitor (C1-INH) concentrate in people with congenital C1-INH deficiency. The study focuses on treating and preventing acute hereditary angioedema attacks before procedures and is designed as a phase 3, randomized, double-blind, placebo-controlled trial conducted across multiple centers. Participants will receive either OCTA-C1-INH, a purified concentrate of human C1-INH given as a slow intravenous injection at a dose of 20 IU per kg of body weight, or a placebo of sodium chloride injection. The treatment is administered after reconstitution in water for injection. The study includes different phases, including treatment of acute attacks and prevention before procedures. During the study, participants will be monitored for the time it takes to experience clear symptom relief within four hours after injection. Researchers will evaluate safety and efficacy through clinical assessments and laboratory tests. Participants must comply with study procedures and attend visits as scheduled. The total duration and follow-up details are organized to ensure thorough evaluation of treatment effects and safety.

Researchers are studying how the neutrophil-to-lymphocyte ratio (NLR), a marker of inflammation from routine blood tests, might help predict the risk of death and major heart events in patients who have experienced Acute Coronary Syndrome (ACS). Despite improvements in heart treatments, mortality after ACS remains significant, and early identification of high-risk patients is important for better care. This study focuses on patients aged 18 to 85 who were diagnosed with ACS and treated with percutaneous coronary intervention (PCI). Participants will have their NLR measured from blood samples taken at hospital admission, then 24 and 48 hours after PCI. The study will observe these patients for up to 6 months after discharge, mainly through phone follow-ups. Researchers will compare NLR levels between different types of ACS, look for links between high NLR and disease severity seen on heart artery scans, and explore how NLR relates to other blood markers like platelet-to-lymphocyte ratio, C-reactive protein, HDL cholesterol, and troponin levels. During the study, patients' outcomes will be monitored, focusing on death from any cause, cardiovascular death, and major acute coronary events within 6 months. The study aims to find simple, cost-effective ways to identify those at greater risk after ACS, potentially guiding future treatment decisions. Follow-up will include phone interviews to track health status and any major heart events occurring during the 6-month period after hospital discharge.