Tirane

Myopia, commonly known as shortsightedness, is a condition influenced by both genetic and environmental factors. It is the most widespread eye disorder globally, with increasing cases especially among children and adolescents, where it tends to worsen. This study, called the MODERATO study, is a phase III clinical trial designed to evaluate how well low-dose atropine eye drops 0.025% and 0.05% work in slowing down myopia progression in children and adolescents aged 3 to under 18 years, compared with placebo, over a 24-month period. Participants will be randomly assigned to one of three groups one receiving 0.05% atropine eye drops, another receiving 0.025% atropine eye drops, and the third receiving placebo eye drops. Each participant will instill one drop in each eye once daily before bedtime. The study includes an adaptive design with an early escape phase at six months, where participants showing worsening myopia on placebo may switch to active treatment, and a planned interim analysis after one year to assess treatment effectiveness and adjust the study as needed. During the study, participants will undergo various eye examinations including refraction tests, pupil diameter measurements, accommodation amplitude, intraocular pressure, stereopsis, slit lamp and macularoptic disc examinations, and ocular biometry. Questionnaires assessing vision-related quality of life and treatment acceptability will also be completed. Safety monitoring will be ongoing, and no follow-up visits are planned after the study ends. The main outcome measured is the mean annual rate of myopia progression over 24 months.

Researchers are evaluating the effectiveness of three biological agentsrecombinant human platelet-derived growth factor rhPDGF, Leukocyte-Platelet Rich Fibrin L-PRF, and Enamel Matrix Derivatives EMDas additional treatments alongside minimally invasive non-surgical periodontal therapy MINST for intrabony defects. This 12-month randomized clinical trial includes 88 patients with single infrabony defects to compare these treatments against MINST alone. The study is designed to assess clinical and radiographic improvements in periodontal condition following treatment. Participants are randomly assigned to one of four groups MINST combined with rhPDGF, MINST plus L-PRF, MINST plus EMD, or MINST alone as a control. The treatment involves debriding the defects using fine ultrasonic tips and hand instruments under local anesthesia, preserving soft tissue stability. In the experimental groups, the defects are filled with either a collagen sponge soaked in rhPDGF, an L-PRF membrane, or EMD gel after MINST, while the control group receives MINST without additional treatment. During the study, patients undergo clinical measurements including clinical attachment level, probing depth, gingival recession, plaque score, and bleeding on probing at baseline, 6 months, and 12 months. Standardized radiographs are taken at the same intervals to assess bone defect characteristics using dental software. The primary outcomes measured at 12 months are defect bone level and clinical attachment level, while secondary outcomes include pocket probing depth, gingival recession, defect angle, and radiographic defect area. The study uses double-blind methods to ensure unbiased assessment of results.

This research aims to assess the effects of MI Paste Plus, a dental cream containing fluoride and casein phosphopeptide-amorphous calcium phosphate CPP-ACP, on the levels of Streptococcus mutans bacteria and the development of white spot lesions WSLs in patients undergoing fixed orthodontic treatment. Fixed orthodontic appliances like brackets and auxiliary devices can promote bacterial growth and enamel demineralization, leading to WSLs that affect tooth appearance and integrity. The study is a prospective, triple-blind, randomized clinical trial involving 200 patients aged 5 to 45 years. Participants will be divided into two groups one group will apply MI Paste Plus once nightly after brushing for three months, while the other group will use a placebo bioadhesive gel with no active ingredients under the same conditions. Both gels look and feel identical to maintain blinding. Participants will continue regular toothbrushing with fluoridated toothpaste. The study also includes stratification by age, oral hygiene risk, and appliance type, with assessments at baseline, one month, and three months. During the study, saliva samples will be collected and analyzed to measure Streptococcus mutans counts. Dental examinations will evaluate white spot lesions using visual inspection ICDAS and quantitative light-induced fluorescence imaging to detect enamel demineralization. Adherence to gel application will be monitored through logs and weighing returned containers. Data collected will help determine if MI Paste Plus reduces bacterial levels and prevents or lessens WSLs during orthodontic treatment.

Researchers are evaluating the pharmacokinetic profile of naldemedine and its metabolite nor-naldemedine after a single oral dose in children aged 2 to 18 years who are receiving or about to receive opioid treatment. The study focuses on pediatric participants experiencing or expected to develop opioid-induced constipation, aiming to understand how the drug behaves in their bodies. This is a Phase 12 open-label study designed to assess safety, tolerability, and drug levels in this population. Participants are divided into three age cohorts 12 to under 18 years, 6 to under 12 years, and 2 to under 6 years. Each participant receives a daily dose of naldemedine, ranging from 0.05 mg to 0.2 mg based on body weight, for 7 days. The drug is given as an oral tablet 0.2 mg dose only or oral suspension all doses. Cohort 3 enrollment occurs after safety and pharmacokinetics data from the first two cohorts are reviewed. During the study, participants will have blood samples collected at multiple time points on Day 1, Day 2, and Day 7 for Cohort 1 to measure drug concentration and related pharmacokinetic parameters. Researchers will also monitor for any treatment-emergent adverse events and assess the ability to swallow tablets and the palatability of the oral suspension. The total participation spans at least 7 days of dosing with monitoring of safety and drug behavior throughout this period.

Researchers are evaluating an intravenous human plasma-derived C1 esterase inhibitor C1-INH concentrate in people with congenital C1-INH deficiency who experience acute hereditary angioedema attacks. This phase 3, randomized, double-blind, placebo-controlled study aims to assess the effectiveness and safety of this treatment both for managing attacks and preventing attacks before medical procedures. Participants receive either OCTA-C1-INH, a purified concentrate of human C1-INH given as a slow intravenous injection at a dose of 20 IUkg body weight, or a placebo injection of saline solution. The treatment is administered after the first qualifying angioedema attack. Both blinded and open-label participants receive OCTA-C1-INH, while only blinded participants receive the placebo. The study uses a parallel group design to compare these interventions. During the study, participants symptoms are closely monitored, focusing on the time to clear symptom relief within 4 hours after injection. Researchers assess symptom severity changes and response rates to the treatment. Participants must comply with all study procedures and are evaluated through clinical assessments and safety monitoring throughout the trial, which lasts until the study completion in June 2027.

Researchers are evaluating the role of the neutrophil-to-lymphocyte ratio NLR as a predictor of mortality in patients who have had an episode of Acute Coronary Syndrome ACS. This observational study focuses on patients admitted with a confirmed diagnosis of ACS, including STEMI and Non-STEMI, who are treated with percutaneous coronary intervention PCI. The study aims to determine if NLR, a simple and cost-effective blood test marker, can help predict death and major heart events within six months after ACS, improving early risk assessment and patient outcomes. Participants will have their NLR measured from blood samples taken at hospital admission, then again at 24 and 48 hours after PCI. The study will collect detailed clinical data including patient information, angiography results, and various blood markers like C-reactive protein and troponin levels. Follow-up will occur through telephone interviews up to six months after discharge, using standardized questionnaires to assess patient health and symptoms. During the study, patients health status will be evaluated at 24 hours, 48 hours, and six months after symptom onset. Researchers will monitor mortality rates, major adverse cardiac events, and associations of NLR with other clinical factors. This comprehensive approach includes gathering clinical records, laboratory results, and patient-reported outcomes to better understand NLRs value in predicting post-ACS risks and potentially guiding future care strategies.