Bayrut

Researchers are evaluating the long-term safety and effects of etavopivat, a new oral medicine being developed for inherited blood disorders such as sickle cell disease and thalassaemia. These conditions affect haemoglobin, the protein responsible for carrying oxygen in the blood. This phase 3 study involves participants who have already completed treatment in a prior etavopivat study and aims to understand how etavopivat performs over an extended period of up to 264 weeks, though the study may end earlier if the drug gains approval locally. Participants will receive oral doses of etavopivat, with different forms A, B, or C given based on their age and condition. Those aged 12 years and older will receive etavopivat A or C, while children under 12 years will receive etavopivat B. The study includes several groups covering various sickle cell disease and thalassaemia categories, including transfusion-dependent and non-transfusion-dependent cases. Treatment is continuous during the study period. Throughout the study, participants will undergo regular monitoring for side effects and treatment responses, including tracking treatment emergent adverse events, hospitalizations, vaso-occlusive crises, hemoglobin concentration changes, and blood transfusion needs. These assessments will help evaluate the drugs safety and efficacy across age groups and disease types. The study is open-label and non-randomized, with follow-up lasting up to about six years.

Researchers are evaluating the effects of etavopivat in adolescents and adults with sickle cell disease. This study aims to confirm whether etavopivat reduces the number of painful vaso-occlusive crises caused by blood vessel blockages. It also examines if the medicine helps reduce organ damage, improve exercise tolerance, and decrease fatigue. The study is a phase 3, randomized, double-blind, placebo-controlled trial lasting about two years. Participants will be randomly assigned to receive either oral etavopivat or a placebo. The treatment is given by mouth, and neither the participants nor the researchers know which treatment is given during the study to ensure impartial results. The primary treatment period is 52 weeks, during which the number of vaso-occlusive crises with medical contact will be measured. Secondary assessments include changes in hemoglobin levels, fatigue scores, walking distance, and other blood markers related to sickle cell disease. During the trial, participants will undergo regular evaluations including blood tests, walking tests, and fatigue assessments from baseline to week 52. Researchers will monitor the safety and effectiveness of etavopivat throughout the study. The total participation time is about two years, with ongoing follow-ups to observe the treatment effects and any side effects. All procedures aim to provide detailed information on how etavopivat affects sickle cell disease symptoms and patient well-being.

Researchers are evaluating the pharmacokinetics and safety of etavopivat in children with sickle cell disease SCD. This phase 12 open-label study involves pediatric participants divided into four age groups, starting with the oldest and moving sequentially to younger cohorts after reviewing safety and pharmacokinetic data. The study aims to understand how the drug behaves in the body and its safety profile in this pediatric population. Participants will receive oral tablets or granules of etavopivat once daily. Each age group, ranging from 6 months to under 18 years, will be treated for a 24-week primary treatment period. Following this, participants will enter a 72-week extension treatment phase to further assess long-term safety and pharmacokinetics. The total duration for each participant is approximately 96 weeks. During the study, participants will undergo various assessments including measuring drug levels in the blood and monitoring for adverse events throughout the 24-week primary treatment and 72-week extension periods. Researchers will also evaluate hemoglobin response, changes in vaso-occlusive crisis frequency, fatigue levels, and blood flow velocity by ultrasound at multiple time points. Safety monitoring and dose adjustments will be tracked, and participants will be followed closely to understand the long-term effects of etavopivat.

This research aims to compare two behavior guidance methods to reduce anxiety in children during local anesthesia injections in dental care. It focuses on children aged 5 to 7 years who need local anesthesia for routine dental treatment. The study evaluates the traditional Tell-Show-Do technique against an artificial intelligence-driven avatar video called the Mini Dentist to see which better helps reduce fear and improve cooperation. Children will be randomly assigned to one of two groups. One group will watch the AI avatar video that explains and demonstrates the injection in a child-friendly way before the procedure. The other group will receive the conventional Tell-Show-Do method, where the dentist verbally explains and shows the procedure before performing it. All injections follow the same standardized protocol and are done by the same pediatric dentist. Participants will have their anxiety measured by monitoring heart rate at five specific times during the injection visit. Pain and behavior will also be assessed using the FLACC behavioral scale and the Wong-Baker FACES pain rating scale. Video recordings of behavior during the injection will be reviewed by trained evaluators. The study is voluntary and approved by an ethics committee, aiming to see if the AI-based method improves anxiety control and cooperation during dental injections.

This research evaluates the long-term safety of asciminib treatment in patients with Philadelphia chromosome-positive chronic myelogenous leukemia CML or acute lymphoblastic leukemia ALL who have completed a prior Novartis-sponsored asciminib study. It is designed to provide continued treatment for participants who, as judged by their investigator, would benefit from ongoing therapy but cannot access it outside the trial. This open-label, multi-center, global roll-over study focuses on assessing safety over an extended period. Participants receive asciminib or other related drugs such as imatinib, nilotinib, bosutinib, or dasatinib, either alone or in combination, based on their previous study treatments. Dosing varies with the specific drug for example, asciminib is taken orally once or twice daily, sometimes in fasting state, and pediatric participants receive a body weight-adjusted dose of asciminib granules. The study includes groups continuing their previous treatment, some switching from bosutinib or dasatinib to asciminib, and combinations with other tyrosine kinase inhibitors. Participants are monitored for adverse events and serious adverse events over eight years as the primary safety outcome. Secondary outcomes include clinical benefit assessments by investigators. During the study, participants undergo scheduled visits, treatment adherence tracking, and safety monitoring. The study spans from August 2022 to August 2030, allowing long-term observation of treatment effects and safety in this patient population.

This research focuses on understanding impedance across different tissue types during ultrasound-guided nerve blocks, including the axillary, interscalene, and popliteal sciatic nerve blocks. The study aims to evaluate how tissue resistance to electrical current affects nerve stimulation and visualization, which could help improve needle placement precision and reduce complications like intraneural or intravascular injections. This observational study is sponsored by Lebanese American University and will run over two years. Participants will undergo nerve blocks guided by ultrasound to measure impedance in various tissues such as skin, fat, fascia, muscle, and near nerves. The study is exploratory and does not involve any additional interventions beyond standard nerve block procedures. The focus is on collecting data on tissue impedance during these procedures to better understand its impact on nerve block accuracy. During the study, participants will be monitored while receiving these nerve blocks, with impedance measurements taken throughout the procedure. Researchers will assess the impedance levels across different tissue types during axillary, popliteal, and interscalene nerve blocks. The primary outcome is to understand impedance variation across tissues over two years. Participants safety will be monitored, and the total duration of involvement will align with the time needed for these measurements within the study period.

Benign prostatic hyperplasia BPH is a common condition affecting many men as they age, often leading to lower urinary tract symptoms LUTS. Due to a growing and aging population, the number of men diagnosed with BPH continues to rise, making treatment for this condition one of the most performed surgical procedures in urology. This research aims to establish a global, ongoing registry that collects detailed demographic and clinical data on men undergoing medical or surgical treatments for BPH to better understand treatment patterns and outcomes worldwide. The registry records information from men aged 18 and older with a primary diagnosis of BPH and LUTS who are receiving either medication or surgical intervention. Data collected includes baseline demographics, peri-operative details, and follow-up outcomes with no actual interventions performed by the registry team. The study uses validated patient-reported outcome measures like the International Prostate Symptom Score IPSS, Sexual Health Inventory for Men SHIM, and Male Sexual Health Questionnaire for Ejaculatory Dysfunction MSHQ-EjD, along with clinical data such as quality of life, urine flow rates, prostate-specific antigen levels, and complications related to treatment. Participants provide data over a period of three years with ongoing follow-up and no fixed end date, allowing for long-term observation of treatment effectiveness and safety. The registry also ensures data security and quality through encryption, user access controls, and regular audits. Researchers will analyze outcomes including symptom scores, quality of life, post-void residual urine, and complications like incontinence, bleeding, urinary tract infections, and erectile dysfunction, aiming to inform future BPH management and research.

This research aims to investigate how specific genetic variations, particularly the A118G single-nucleotide polymorphism SNP in the mu-opioid receptor 1 OPRM1 gene and several SNPs in the Catechol-O-methyltransferase COMT gene, may influence postoperative pain and other recovery-related outcomes in children aged 8 to 18 undergoing various surgeries including orthopedic, abdominal, thoracic, and plastic procedures. The study focuses on understanding differences in pain sensitivity and opioid response among children due to these genetic factors. This is a prospective observational study involving about 200 children who will be monitored for their postoperative pain scores and other recovery aspects without altering their usual care. Researchers will assess pain levels, sedation, opioid use during and after surgery, the duration of stay in the post-anesthesia care unit PACU, and occurrences of respiratory depression or nausea and vomiting. Genetic testing will be conducted, but the study does not involve any experimental treatments. Participants will be evaluated during surgery and until discharge from the PACU, approximately 3 hours postoperatively. Data collected include pain scores, sedation levels, opioid requirements, and recovery duration, along with monitoring for side effects like respiratory depression and nausea. The study will use statistical analyses to explore how genetic differences relate to these outcomes, with the goal of improving personalized pain management for children undergoing surgery.

Researchers are evaluating sedation protocols for adults undergoing cataract surgery to find the best approach for patient comfort and safety. This study compares the effects of three sedation methods dexmedetomidine combined with fentanyl, propofol combined with fentanyl, and a combination of dexmedetomidine, propofol, and fentanyl. The goal is to understand how these protocols impact sedation levels, heart rate, blood pressure, respiratory events, surgeon satisfaction, and side effects like bradycardia, hypotension, and nausea. Participants will be randomly assigned to one of three groups receiving different sedation treatments. The dexmedetomidine groups receive a loading dose followed by maintenance infusion, propofol is given via target-controlled infusion to reach a specific sedation level, and all groups receive a single bolus of fentanyl. Three anesthesiologists will administer the protocols during elective cataract surgery on one or both eyes, with monitoring throughout the procedure and recovery. During the study, trained anesthesiologists and nurse anesthetists will assess sedation using the Ramsay sedation scale during surgery and in recovery. Participants will be closely monitored for vital signs and adverse effects. Surgeons will share their satisfaction with the sedation. The main outcomes measured are sedation levels during surgery and recovery, tracked over approximately one year. Safety and comfort will be carefully observed throughout the study period.

Researchers are studying dental implant placement in the atrophic posterior maxilla, a challenging area due to complex bone remodeling and changes in the maxillary sinus and alveolar ridge shape. The study aims to evaluate the long-term success of implants placed after sinus grafting, focusing on the effect of apical implant positioning on bone remodeling, crown characteristics, and patient satisfaction. This observational cross-sectional study also seeks to develop a classification system to help clinicians decide on treatments for atrophic posterior maxilla cases. The study involves partially edentulous patients who have received implant rehabilitation with a sinus lift procedure in the atrophic posterior maxilla. Researchers will analyze patient records and recall patients for clinical and radiographic examination, including bone remodeling measurements, probing depth, bleeding on probing, and assessments of crown bulkiness and height. Patients will also complete a questionnaire about their satisfaction and oral hygiene ease. Digital analysis of 3D cone beam CT scans will be performed to measure bone and crown parameters and simulate bone graft shapes. Participants will be involved in clinical exams, radiographic measurements, questionnaires, and digital imaging assessments. Researchers will monitor peri-implant bone remodeling, probing depth, and bleeding around implants as primary outcomes. Secondary outcomes include keratinized tissue width, crown-to-implant ratio, crown dimensions, emergence angle, and patient-reported outcomes. The study timeline includes data collection, patient recall, statistical analysis, classification establishment, and thesis submission, with study completion expected by mid-2026.