Aydin Merkez

Researchers are comparing two treatment combinations for adults with advanced nonsquamous non-small cell lung cancer NSCLC that have a specific KRAS p.G12C mutation and are negative for PD-L1 expression. The study aims to evaluate progression-free survival and overall survival between participants receiving sotorasib with platinum doublet chemotherapy and those receiving pembrolizumab with platinum doublet chemotherapy. This phase 3, randomized, open-label trial is led by Amgen and includes participants with stage IV or advanced stage IIIBC NSCLC. Participants will be randomly assigned to receive either sotorasib orally combined with carboplatin and pemetrexed, or pembrolizumab intravenously combined with the same chemotherapy drugs. These treatments are given as front-line therapy. The study includes a treatment period with these drug combinations and monitoring for outcomes such as response rates and quality of life over several years. During the study, participants will be regularly assessed through various measures including survival status, tumor response, and quality-of-life questionnaires focusing on lung cancer symptoms. Researchers will monitor safety by tracking adverse events, vital signs, and laboratory tests. Treatment concentrations of sotorasib will also be measured up to 64 days after starting. The total study duration includes follow-up for up to approximately 5.5 years to fully evaluate treatment effects and outcomes.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are evaluating the addition of Tersolisib LY4064809STX-478 to other anti-cancer drugs as a first treatment for adults with advanced hormone receptor-positive HRhuman epidermal growth factor receptor 2-negative HER2- breast cancer that has a PIK3CA mutation. This Phase 3 randomized, double-blind, placebo-controlled trial aims to understand the efficacy and safety of this combination compared to placebo, focusing on improving outcomes for patients with this specific genetic change. Participants receive LY4064809 orally in one of two doses combined with a CDK46 inhibitor such as Ribociclib, Palbociclib, or Abemaciclib and endocrine therapy ET administered orally or via intramuscular injection. The comparison group receives a placebo combined with the same CDK46 inhibitor and ET. The study includes two parts Part 1 explores dose optimization, and Part 2 evaluates the treatment combinations effectiveness and safety as a first-line therapy. During the study, participants will have regular assessments to monitor cancer response, progression, and safety over an estimated period of up to 5 years or more. Researchers will measure outcomes such as overall response rate, progression-free survival, duration of response, overall survival, and quality of life. Treatment continues as long as the cancer benefits without intolerable side effects. Safety monitoring, laboratory tests, and quality of life questionnaires are part of the participant involvement throughout the trial.

This research aims to evaluate the safety, performance, and usability of several Occlutech accessory medical devices used in heart disease treatment. These devices include the Occlutech Delivery Set ODS, Occlutech Pistol Pusher OPP, Occlutech Occlusions-Pusher OOP, and Occlutech Sizing Balloon OSB. The study is international, multicenter, non-randomized, and non-invasive, focusing on catheter-based implantation procedures for cardiac implants. The study involves physicians experienced in cardiac catheterization using these accessories during implantation procedures. Investigators complete detailed surveys to assess each devices safety, including success of implantation, adverse events during or after the procedure, user harm, and any device deficiencies. The surveys also evaluate the performance, usability, and compatibility of these accessories with other devices. Subjects receive treatment following standard clinical routines and specific instructions for use. Participants who have undergone implantation with an Occlutech accessory and cardiac implant are included. Researchers monitor safety events and assess device performance and usability over a 6-month period. Data is collected via investigator questionnaires, focusing on implantation outcomes and any related complications. The total participation duration varies depending on individual follow-up but includes at least 6 months of monitoring for safety and performance.

Researchers are studying children aged 6 months to 5 years who have acute gastroenteritis, a common cause of dehydration and emergency visits. The study compares two types of intravenous fluids used for rehydration normal saline, which has a high chloride content, and balanced crystalloids like Isolyte-S, which contain acetate and gluconate to help neutralize acid. The goal is to see if balanced fluids improve blood bicarbonate levels and other clinical outcomes compared to normal saline. The study observes children who receive either normal saline or the balanced crystalloid Isolyte-S as part of their routine care, with the treating physician deciding which fluid to use independently. No additional tests or treatments are given for research purposes. Data are collected at baseline when fluids start, about 4 hours later from routine blood tests, and 72 hours after discharge to check for return visits. During participation, childrens blood tests taken as part of standard care are reviewed to evaluate changes in serum bicarbonate, blood pH, chloride levels, and other measures like time to first oral intake and hospital admission. Researchers also track if additional IV fluid boluses are needed and monitor for emergency return visits within 72 hours. The study lasts through these observation points without extra procedures beyond usual care.

Researchers are evaluating the current risk of tooth decay in children who had dental treatment under general anesthesia for early childhood caries ECC between 2015 and 2020 at Ayd31n Adnan Menderes University. This observational, cross-sectional study focuses on systemically healthy children aged 6 to 16 years. The goal is to better understand caries risk profiles to support long-term prevention and oral health policies for children treated under anesthesia for ECC. Participants will undergo a single visit where their caries risk is assessed using the Cariogram model. This model combines clinical dental measures like decayed, missing, or filled teeth DMFTdmft, plaque and gingival health, probing depth, and salivary factors such as stimulated flow rate and buffering capacity. Standardized questionnaires will also gather information on diet, fluoride use, socioeconomic status, and dental history. No treatments will be given during the study data is collected solely for analysis. During the study visit, children will have clinical dental exams, saliva tests, and complete questionnaires. Researchers will measure caries risk and related factors including plaque index, gingival index, and fluoride exposure. Data analysis will use statistical software. The studys findings aim to guide better monitoring and prevention strategies for children at high risk of caries after treatment under general anesthesia, helping to shape future oral health care and policy.

Researchers are studying children aged 1 month to 18 years who are receiving mechanical ventilation due to acute respiratory failure or pediatric respiratory distress syndrome. The study aims to compare the safety and effectiveness of a closed-loop synchronization controller with conventional manual synchronization during invasive mechanical ventilation of spontaneous breathing pediatric patients in a pediatric intensive care unit PICU. The trial involves two treatment periods, each lasting one hour. In one period, the pressure support of the childs spontaneous breathing will be automatically adjusted by the closed-loop synchronization controller using analysis of pressure and flow waveforms. In the other period, the pressure support will be manually set using conventional synchronization settings. This is a randomized crossover study where participants receive both interventions. During the study, researchers will monitor and measure the asynchrony index, major and minor asynchronies, comfort behavioral score, air leak, oxygen saturation SpO2, and end-tidal carbon dioxide EtCO2 during each one-hour treatment period. The trial involves close observation and evaluation of how well the synchronization methods support the childs breathing while minimizing asynchrony and discomfort.

This research aims to compare the clinical success and parental satisfaction of prefabricated stainless steel crowns and zirconia crowns used on childrens primary mandibular second molars after pulpotomy treatment for deep, multi-surface caries. The study focuses on dental caries and pulpotomy, assessing how these two crown types affect periodontal health, plaque buildup, tooth wear, and various clinical performance factors such as color match and retention. Two groups of children aged 4 to 5 years will receive either a prefabricated stainless steel crown or a zirconia crown on opposite primary mandibular second molars using a split-mouth design. Treatments include pulpotomy followed by crown preparation and cementation using specific dental materials and procedures. The crowns will be cemented with FujiCEM Evolve, and detailed preparation methods differ between the two crown types to ensure proper fit. The study will continue until all follow-up visits are completed and data finalized. Participants will be evaluated at baseline, then at 1, 3, 6, and 12 months after treatment. Assessments include periodontal health indexes, plaque accumulation, opposing tooth wear, and clinical performance measures such as marginal integrity and postoperative sensitivity. Parental satisfaction will also be measured at these intervals. Intraoral photographs will be taken immediately after treatment and during each follow-up to document changes. The study monitors for clinical success factors and potential failures such as crown decementation or tooth abscesses.

Researchers are studying pediatric patients with acute respiratory distress syndrome and acute respiratory failure who require mechanical ventilation. The study focuses on measuring transpulmonary pressure PL, which is important for safe and effective ventilation. Since direct measurement of pleural pressure Ppl risks tissue damage, esophageal pressure Pes is used as a safer surrogate. However, measuring Pes accurately can be challenging due to potential errors from incorrect catheter filling volumes. The trial compares two methods of adjusting the esophageal catheters filling volume to optimize Pes measurement in children a faster decremental method and the conventional Mojoli method. Participants will be randomly assigned to receive either the fast decremental volume titration or the conventional titration technique. Both approaches aim to find the optimal catheter volume within one hour after placement. During the study, children on mechanical ventilation will receive esophageal catheter insertion, and clinicians will monitor and measure Pes and transpulmonary driving pressure over the hour after catheter placement. The primary outcome is determining the best catheter filling volume secondary outcomes include the transpulmonary driving pressure and the time taken for measurement. The study is double-blind and randomized, ensuring careful assessment of each methods accuracy and efficiency.