Rize Merkez

This research investigates treatments for metastatic castration-resistant prostate cancer mCRPC focusing on a drug called ifinatamab deruxtecan I-DXd. The study aims to assess the safety, how well participants tolerate the treatments, and appropriate dosing levels of I-DXd alone or combined with other therapies. Researchers will also monitor participants prostate specific antigen PSA levels during treatment to understand its effects. Participants are assigned to one of several treatment groups. One group receives docetaxel every three weeks for up to 10 cycles. Other groups receive I-DXd alone or combined with either opevesostat or androgen receptor pathway inhibitors such as abiraterone acetate or enzalutamide. I-DXd is given every three weeks until unacceptable side effects, disease progression, death, or withdrawal, while the other drugs continue until specific discontinuation criteria are met. Premedication is required before each I-DXd dose to prevent nausea and vomiting. Throughout the study, participants undergo various assessments including monitoring of dose-limiting toxicities, adverse events, and PSA response rates. Researchers also track objective response rates, progression-free survival, overall survival, and other clinical outcomes over up to approximately 54 months. The study involves regular evaluations to assess safety and treatment effects until study completion.

Researchers are investigating new treatment options for breast cancer that is hormone receptor-positive HR and human epidermal growth factor receptor 2-negative HER2-, specifically for cases that are unresectable locally advanced or metastatic. This type of breast cancer involves cancer cells that depend on hormones like estrogen or progesterone and have low HER2 protein levels. The study focuses on comparing the effects of patritumab deruxtecan against chemotherapy or trastuzumab deruxtecan in patients whose cancer has progressed despite prior treatments. Participants receive either patritumab deruxtecan through intravenous infusions every three weeks for about 13 months or a treatment chosen by their physician, which may include various chemotherapy drugs or trastuzumab deruxtecan, administered according to specific schedules for up to 13 months. The study is randomized and open-label, meaning participants are randomly assigned to one of the treatment groups, and both the patients and researchers know which treatment is given. Throughout the study, participants undergo regular assessments to monitor cancer progression and overall survival for up to approximately 85 months. Researchers evaluate tumor response, duration of response, and changes in quality of life using standardized questionnaires. Safety is carefully monitored by recording adverse events and treatment discontinuations. The goal is to understand if patritumab deruxtecan can improve outcomes compared to current treatment options.

Researchers are evaluating whether retatrutide and tirzepatide can prevent major adverse liver outcomes in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized controlled trial aims to assess these treatments compared to placebo in about 4,500 adults over approximately 224 weeks. The study is sponsored by Eli Lilly and Company and focuses on liver disease progression and related health measures. Participants will be randomly assigned to receive retatrutide, tirzepatide, or placebo, all administered by subcutaneous injection. The trial includes two placebo groups corresponding to each experimental drug. After completing the main study, eligible participants may join a 2-year extension where all will receive either retatrutide or tirzepatide regardless of their initial assignment. During the study, participants may attend around 25 to 30 clinic visits for health monitoring, study procedures, and assessments of liver function and disease status. Researchers will measure the time to major adverse liver outcomes, changes in liver fibrosis scores, liver stiffness, liver fat content, liver enzyme levels, body weight, and cardiovascular events. Monitoring will continue from baseline through study completion, with detailed evaluations at multiple timepoints including week 104.

Researchers are evaluating efruxifermin EFX in a phase 3, randomized, double-blind, placebo-controlled study involving adults with compensated cirrhosis caused by NASH Nonalcoholic Steatohepatitis or MASH Metabolic Dysfunction-Associated Steatohepatitis. This study aims to assess the safety and effectiveness of EFX in preventing significant clinical events such as disease progression and liver decompensation over a period of up to 5 years. Participants are randomly assigned to receive either efruxifermin 50 mg or a placebo, both given by subcutaneous injection. The study includes two cohorts one with biopsy-proven compensated cirrhosis and specific metabolic scores, and another with biopsy-proven or non-invasive diagnosis of compensated cirrhosis. The study treatment and monitoring extend up to 5 years, with evaluations at 96 weeks and long-term follow-up to track liver fibrosis, markers of liver injury, insulin sensitivity, glycemic control, body weight, and safety outcomes. During the trial, participants undergo regular assessments including laboratory tests, ECGs, ultrasounds, and vital sign monitoring. Researchers will measure changes in liver fibrosis, steatohepatitis resolution, and metabolic markers throughout the study. Safety and tolerability are closely tracked by documenting adverse events and exposure duration. The study duration allows for long-term observation of treatment effects and disease progression, with participant involvement lasting up to 5 years.

Researchers are evaluating efruxifermin EFX in adults with non-cirrhotic nonalcoholic steatohepatitis NASH or metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage 2 or 3. This Phase 3, multi-center, randomized, double-blind, placebo-controlled study aims to assess the safety and efficacy of EFX compared with placebo. The trial includes about 1,650 participants divided into two cohorts based on liver biopsy characteristics and fibrosis stage. Participants will be randomly assigned to one of three groups EFX 28 mg, EFX 50 mg, or placebo, each given as a weekly subcutaneous injection. Cohort 1 will be evaluated over 52 weeks for histologic efficacy endpoints, while Cohort 2 will have assessments over 96 weeks. After these periods, participants may continue long-term treatment and clinical follow-up for up to approximately 240 weeks total. A follow-up visit will occur about 30 days after the last dose. During the study, participants will undergo liver biopsies, blood tests, and non-invasive assessments such as FibroScan and Enhanced Liver Fibrosis ELF score to monitor liver health and fibrosis. Researchers will track liver-related clinical outcomes, including liver events and survival, as well as safety and tolerability of the treatment. Participants who stop the study drug may still continue with scheduled assessments to support long-term safety and efficacy evaluations.

Researchers are evaluating the safety, tolerability, and initial effects of two dosages of golexanolone compared to placebo in adults with Primary Biliary Cholangitis PBC who experience significant fatigue and cognitive symptoms. This phase 1b2 randomized, double-blind, placebo-controlled study focuses on patients with non-cirrhotic or mild cirrhotic PBC Child-Pugh class A who are on stable standard care medication. The study aims to understand how golexanolone affects fatigue, daytime sleepiness, cognitive function, and overall quality of life. The study has two parts Part A assesses safety, tolerability, and pharmacokinetics of golexanolone 40 mg taken twice daily for 5 days. Part B evaluates safety, tolerability, and effects of two dose levels 40 mg and 80 mg, twice daily compared to placebo over 28 days. Participants receive soft gelatin capsules orally twice daily during these periods. The study uses a parallel design with randomized allocation and quadruple masking to compare golexanolone doses and placebo. Participants will be monitored from enrollment through 5 days in Part A and 28 days in Part B, with assessments including adverse event tracking, quality of life questionnaires PBC-40, EQ-5D-3L, sleepiness scales, cognitive tests, and investigator impressions of treatment effect. Pharmacokinetic sampling occurs on days 1, 14, and 28 in Part B. Safety and tolerability are closely observed, with the total participation lasting up to 28 days depending on the part enrolled.

Researchers are investigating the impact of anti-inflammatory nutrition on the success of non-surgical periodontal treatment in people with periodontitis who follow a pro-inflammatory diet. The study aims to assess changes in specific biomarkers found in gingival crevicular fluid and blood serum, as well as clinical periodontal health parameters. This observational study will include 100 adults aged 20 to 65 years who have periodontitis and a dietary inflammatory index greater than zero. Participants will be divided into four groups based on diet inflammatory scores and whether they receive anti-inflammatory nutrition education. All will undergo non-surgical periodontal treatment. Two groups Q3-1 and Q4-1 will receive both the periodontal treatment and nutrition education, while the other two groups Q3-2 and Q4-2 will receive only the periodontal treatment. Samples and measurements will be collected at baseline, 1.5 months, and 3 months after treatment to evaluate changes. Throughout the study, participants will have clinical periodontal assessments and provide gingival fluid and blood samples to measure levels of inflammatory and oxidative stress markers like interleukins, tumor necrosis factor, total oxidant and antioxidant status, and C-reactive protein. Researchers will track periodontal pocket depth and clinical attachment loss over time. The study will last about 3 months after treatment, with multiple follow-up visits to monitor changes and treatment outcomes.

Researchers are investigating the relationship between hyperuricemia, a condition with high serum uric acid levels, and periodontitis, a chronic gum disease causing inflammation and bone loss. The study aims to understand how hyperuricemia may influence periodontitis through inflammation, oxidative stress, and bone metabolism. This observational research includes 80 adults aged 18 to 65, divided into four groups based on gum health and uric acid levels. Participants will have their periodontal health evaluated using clinical measures such as probing pocket depth and clinical attachment loss. Gingival crevicular fluid and blood serum samples will be collected to analyze markers related to inflammation, oxidative stress, and bone metabolism, including various interleukins and nuclear factor kappa B ligand. The study groups include those with and without periodontitis and hyperuricemia. Throughout the study, participants will undergo thorough assessments of periodontal parameters alongside laboratory tests on collected samples. The main outcomes measured are periodontal pocket depth and clinical attachment loss at baseline, with additional analysis of inflammatory markers. The study is conducted by Recep Tayyip Erdogan University Training and Research Hospital and is expected to complete by October 2026.

Researchers are studying patients with latent Hepatitis B virus HBV infection who require immunosuppressive therapy and antiviral prophylaxis. The study aims to monitor long-term effects on bone, kidney, and metabolic health associated with oral antiviral treatment and other health factors. This multicenter, prospective research hopes to improve understanding of the safety and management of HBV prophylaxis in immunocompromised patients. Participants will include those starting HBV antiviral prophylaxis under immunosuppressive treatment. The study will follow patients for four years, collecting data at multiple time points including baseline, and weeks 6, 12, 24, and 48. Assessments will include bone density scans, kidney function tests, metabolic profiles, and liver evaluations to analyze organ health during antiviral use. Throughout the study, patients will attend scheduled visits for comprehensive monitoring of their bone, kidney, metabolic, and liver status. Data will be recorded in a centralized system to ensure accurate tracking. The main outcomes measured are kidney function, bone health, and metabolic status over the first year, with additional liver assessments. Participation includes regular testing and follow-up to understand long-term effects of antiviral therapy.

Researchers are investigating the effects of Intermittent Kangaroo Mother Care KMC in the early postpartum period on breastfeeding success and how mothers perceive their maternal role. This randomized controlled trial involves primiparous mothers who have given birth vaginally and aims to compare intermittent KMC with routine postpartum care in a hospital setting. The study is conducted between June 2025 and June 2026 at the Bucak State Hospital Delivery Unit and is sponsored by Recep Tayyip Erdogan University. The intervention group will provide intermittent Kangaroo Mother Care by placing their newborns in an upright chest-to-chest position on their bare chest for 24 hours after birth. Mothers will perform KMC sessions lasting about 60 minutes after each breastfeeding, which occurs every 2 to 3 hours. The control group will receive the hospitals standard postpartum care, which includes routine skin-to-skin contact and breastfeeding support without additional KMC sessions. Data collection happens at baseline immediately after the first breastfeeding and again at 24 hours postpartum. Participants will complete assessments using the LATCH Breastfeeding Assessment Tool and the Semantic Differential Scale-Myself as a Mother to measure breastfeeding success and maternal role perception. These assessments occur twice once within the first hour after birth and again at the 24th hour. The study monitors breastfeeding and maternal perceptions over this period, with statistical analyses planned to compare groups. Total participation involves hospital stay during the first postpartum day with data collected at two key timepoints.