Aydin Merkez

Researchers are evaluating the effectiveness, safety, and tolerability of two different doses of remibrutinib compared to a placebo in adults and adolescents with moderate to severe hidradenitis suppurativa (HS). This phase 3 study aims to determine how well remibrutinib works in treating this chronic skin condition characterized by painful abscesses and inflammatory nodules. The study lasts a total of 76 weeks and includes several phases: up to 4 weeks for screening, followed by a 16-week double-blind treatment period where participants receive either remibrutinib Dose A, Dose B, or a matching placebo. After this, there is a 52-week treatment period where all participants receive remibrutinib (Dose A or Dose B). Finally, a 4-week safety follow-up period occurs without treatment. Participants who stop treatment early are encouraged to stay in the study and complete the safety follow-up. During the study, participants will be regularly assessed for clinical response to treatment, focusing on the proportion achieving a 50% improvement in HS symptoms by week 16. Researchers will monitor safety and tolerability throughout the study, including during the follow-up period. Various evaluations such as physical exams and clinical assessments will be conducted to measure treatment effects and ensure participant safety over the entire 76-week duration.

Researchers are conducting a Phase 3 study to compare two front-line treatments for adults with nonsquamous non-small cell lung cancer (NSCLC) that is stage IV or advanced stage IIIB/C. The study focuses on patients whose tumors have a KRAS p.G12C mutation and are negative for PD-L1 expression. The main goal is to evaluate how each treatment affects progression-free survival and overall survival over about 2.5 years. Participants will be randomly assigned to receive either sotorasib combined with platinum doublet chemotherapy or pembrolizumab combined with platinum doublet chemotherapy. Sotorasib is given orally, while pembrolizumab is given intravenously. Both groups will receive the combination therapies as their initial treatment for advanced NSCLC. During the study, participants will be monitored regularly to assess treatment effects and safety. Researchers will track how long patients live without the cancer worsening and overall survival over approximately 2.5 years. The study includes evaluations to determine eligibility and ongoing assessments to monitor health and treatment response throughout the trial period.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

This research aims to evaluate the safety, performance, and usability of Occlutech accessory medical devices used in cardiac implant procedures. It is an international, multicenter, non-randomized, non-invasive registry study focusing on devices such as the Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP), Occlutech Occlusions-Pusher (OOP), and Occlutech Sizing Balloon (OSB). The study collects data through investigator-completed surveys to monitor device-related outcomes during and after catheter-based cardiac implant interventions. The study involves the use of the specified Occlutech accessory devices by experienced physicians skilled in cardiac catheterization and interventional operations. Investigators complete detailed questionnaires assessing the success of implantation procedures, any adverse events occurring during or after the procedures, user harm related to the accessories, and any device deficiencies. The surveys also evaluate performance, usability, and compatibility of the accessories with other devices. Participants are treated following the implants' and accessories' instructions for use and standard clinical practice. Participants' involvement includes undergoing implantation procedures with these accessory devices, after which investigators collect data via surveys. The study monitors safety events over six months, including any adverse outcomes linked to the accessories or procedures. The collected information helps assess the devices' safety profile and practical use in real-world clinical settings. The total duration of monitoring and follow-up is six months per participant to capture both immediate and longer-term effects.

Researchers are evaluating the current risk of tooth decay in children who were treated under general anesthesia for early childhood caries (ECC) at Aydın Adnan Menderes University between 2015 and 2020. ECC is a common chronic childhood disease affecting young children, especially those from low socioeconomic backgrounds. Despite improved access to dental care, the high rate of ECC and recurring decay highlights the need for better long-term preventive strategies for this high-risk group. Participants will attend a single visit where their caries risk will be assessed using the Cariogram model. This evaluation combines clinical dental exams measuring decay, plaque, gum health, and probing depth with salivary tests for flow rate and buffering capacity. Standardized questionnaires will also gather information on diet, fluoride use, socioeconomic status, and dental visit history. No treatment will be given; all data collected will be used for observational analysis. During the visit, researchers will collect clinical, salivary, and questionnaire data to analyze each child's current caries risk profile. The study aims to provide important scientific evidence to help improve long-term oral health care and preventive programs for children treated under general anesthesia for ECC. This one-time assessment will support efforts to develop effective policies and preventive models for managing caries risk in this vulnerable population.

Researchers are studying the safety and effectiveness of a closed-loop synchronization controller compared to conventional synchronization during invasive mechanical ventilation for spontaneous breathing in pediatric patients. This trial focuses on children treated in a pediatric intensive care unit (PICU) who experience acute respiratory failure or pediatric respiratory distress syndrome. Previous research showed that ventilator-patient asynchrony is common and varies in type and severity, but no standard categorization exists. This study aims to address these issues by evaluating a new ventilation control method. The study compares two methods during a one-hour period: a closed-loop synchronization controller that automatically adjusts pressure support based on patient pressure and flow waveforms, and conventional synchronization where pressure support is manually set for spontaneous breathing. Both methods use the SPONT mode on mechanical ventilators. The trial employs a randomized cross-over design where each participant receives both interventions for comparison. Participants will be monitored for ventilator-patient asynchrony using an asynchrony index measured over one hour. Data collection includes analyzing pressure and flow waveforms to assess ventilation quality and synchronization. Safety and efficacy outcomes will be evaluated by comparing these two ventilation approaches during the study period. The trial includes children aged more than 1 month up to 18 years who require mechanical ventilation with spontaneous breathing activity in the PICU.

Researchers are evaluating the clinical success, parental satisfaction, and effects on gum health of prefabricated zirconia crowns compared to prefabricated stainless steel crowns in children aged 4 to 5 years. These crowns are used to restore primary mandibular second molars affected by multi-surface deep caries that require pulpotomy treatment. The study aims to assess differences in gum health, plaque buildup, opposing tooth wear, clinical performance, and parental satisfaction between the two crown types. The study uses a split-mouth design where each child receives both a zirconia crown and a stainless steel crown on opposite primary mandibular second molars after pulpotomy. The crowns are applied following detailed preparation and cementation procedures, including local anesthesia, pulp removal, and tooth shaping. The crowns are cemented using a special resin-modified cement, and care is taken to ensure proper fit and occlusion. Follow-up visits occur at 1, 3, 6, and 12 months to monitor outcomes. Participants will have assessments of gum health and plaque levels at baseline and during follow-ups. The wear on opposing natural teeth, clinical performance of crowns (including color match, retention, and surface quality), and parental satisfaction will also be measured at these times. Intraoral photographs will be taken after treatment and at each visit. The study tracks any tooth extractions, crown failures, root resorption, or other complications as part of evaluating success over the one-year period.

Mechanical ventilation is a critical intervention in the management of pediatric patients with respiratory distress. During this process, accurate measurement of transpulmonary pressure (PL) is essential to ensure the safety and efficacy of ventilation. PL is defined as the difference between alveolar pressure (Palv) and pleural pressure (Ppl). While the direct measurement of Ppl is possible, it poses a risk to tissue integrity. Thus, the primary surrogate for Ppl measurement today is esophageal pressure (Pes). However, the measurement of Pes is not without challenges. This abstract outlines the pitfalls associated with Pes measurement, emphasizing the importance of employing well-defined procedures to mitigate potential errors. These errors can range from underestimation of Pes due to underfilled catheters to overestimation resulting from overfilled catheters. To address these challenges and optimize Pes measurement, various methods have been proposed for titrating the filling volume of the esophageal catheter. In this study, investigators aim to assess a faster decremental filling method and compare it to the traditionally accepted Mojoli method in the context of pediatric patients. This research seeks to enhance the intensivists' understanding of the most efficient and accurate approach to Pes measurement during mechanical ventilation in the pediatric population, ultimately contributing to improved patient care and outcomes

Researchers are evaluating the effectiveness of a bilateral Rhomboid Intercostal Block (RIB) for managing pain after elective bilateral breast implant surgery. This randomized, single-center study includes female patients aged 18 to 65 years with ASA physical status I-II. The goal is to see if adding RIB to standard general anesthesia reduces opioid use and improves pain control compared to general anesthesia alone. Participants will be randomly assigned to either receive ultrasound-guided bilateral RIB, which involves injecting a local anesthetic mixture near the shoulder blade before surgery, or to a control group receiving only standardized general anesthesia. All patients will then receive postoperative pain relief through patient-controlled intravenous tramadol, dosed based on body weight. The RIB uses 30 mL of a mixed local anesthetic solution per side, delivered under aseptic conditions using ultrasound guidance. Patients will be monitored for 24 hours after surgery with pain assessments at multiple time points using visual scales. Researchers will measure total tramadol use in the first 24 hours as the main outcome. Secondary outcomes include pain intensity over time, time until first additional pain relief is needed, use of rescue medications, nausea and vomiting occurrence, and any block-related side effects. The study is conducted under ethical approval with close monitoring of safety and analgesic effectiveness.