Rize Merkez

Researchers are evaluating the safety and effectiveness of ifinatamab deruxtecan (I-DXd) alone or combined with other treatments in people with metastatic castration-resistant prostate cancer (mCRPC). This study aims to understand how well patients tolerate the treatment, find a safe dose for combining I-DXd with other drugs, and measure prostate-specific antigen (PSA) levels during treatment. The study is part of a larger master screening protocol and includes patients with confirmed prostate adenocarcinoma who have progressive disease despite prior therapies. Participants receive treatments including I-DXd given through intravenous infusion, sometimes combined with other drugs such as docetaxel (IV), MK-5684, abiraterone, or enzalutamide (all oral). Before each I-DXd dose, patients take premedication to prevent nausea and vomiting. The study includes both a safety lead-in phase and an efficacy phase, with ongoing monitoring for side effects and tolerability. The combination therapies are carefully dosed and scheduled according to the study protocol. During the study, participants undergo regular assessments to monitor side effects, measure PSA response, and track any dose-limiting toxicities. Safety is closely followed, particularly during the first 21 days for combination treatments, and throughout up to 54 months for long-term outcomes. Researchers also observe if participants discontinue treatment due to adverse events. The study requires ongoing visits and evaluations to ensure participant health and collect data on treatment effects over time.

Researchers are evaluating treatments for breast cancer that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), specifically in cases where the cancer is either locally advanced and cannot be removed by surgery or has spread to other parts of the body (metastatic). The study aims to determine if patritumab deruxtecan (also called HER3-DXd or MK-1022) helps patients live longer overall or without the cancer growing compared to chemotherapy or trastuzumab deruxtecan. This is a Phase 3 clinical trial focusing on this particular type of breast cancer. Participants receive one of several treatments: patritumab deruxtecan through intravenous infusion, chemotherapy options like paclitaxel or nab-paclitaxel via IV, oral capecitabine tablets, liposomal doxorubicin via IV, or trastuzumab deruxtecan via IV infusion. The study compares the effects of patritumab deruxtecan alone to the treatment chosen by the physician. Treatments are administered according to standard dosing schedules during the trial. During the study, participants are monitored for how long they live without the cancer progressing (up to about 45 months) and overall survival (up to about 85 months). Researchers assess disease status through imaging and other evaluations. Participants have regular check-ups to monitor health, treatment effects, and any side effects. The study tracks treatment response and safety over the extended follow-up period to understand the benefits and risks of the therapies.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are evaluating efruxifermin (EFX) in adults aged 18 to 80 who have compensated cirrhosis caused by nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the safety and effectiveness of EFX in improving liver health and delaying disease progression in this population. The study focuses on subjects with advanced liver fibrosis (stage 4) but without liver decompensation. Participants are randomly assigned to receive either efruxifermin or a placebo, both administered by subcutaneous injection. The study includes two cohorts: Cohort 1 requires biopsy confirmation of liver fibrosis and specific metabolic features, while Cohort 2 allows biopsy or non-invasive diagnosis. Treatment and observation continue over an extended period to evaluate changes in liver fibrosis and clinical events. During the study, researchers will monitor the time until significant clinical events such as disease progression or liver decompensation occur, with a follow-up of up to five years. For Cohort 1, the proportion of participants showing improvement in fibrosis without worsening steatohepatitis will be assessed at 96 weeks. Participants will undergo regular evaluations including clinical assessments and laboratory tests to track liver function and safety throughout the study period.

Researchers are investigating the safety and effectiveness of efruxifermin in people with non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis (stage 2 or 3). This Phase 3 study is randomized, double-blind, and placebo-controlled, enrolling a total of 1650 participants in two groups to evaluate treatment outcomes. Participants will receive either efruxifermin or a placebo by subcutaneous injection. The study involves two cohorts, with Cohort 1 including patients who have biopsy-confirmed NASH or MASH and specific liver fibrosis and activity scores. The treatment period and detailed dosing schedules are not provided but the study compares the effects of the active drug against placebo. During the study, participants will be monitored for improvement in liver disease status, including resolution of NASH/MASH and at least a one-stage improvement in liver fibrosis after 52 weeks for Cohort 1. Long-term outcomes such as event-free survival will be observed over 240 weeks. Safety and efficacy assessments will be conducted throughout the study period, including evaluations of liver histology and metabolic health.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary effectiveness of two different doses of golexanolone compared to a placebo in adults with Primary Biliary Cholangitis (PBC) who experience significant fatigue and cognitive symptoms. This phase 1b/2 randomized, double-blind, placebo-controlled study includes participants with non-cirrhotic or Child-Pugh class A cirrhotic PBC who are on stable standard of care medication. The study aims to understand the effects of golexanolone on health-related quality of life, including fatigue, daytime sleepiness, and cognitive function. Participants receive soft gelatin capsules of golexanolone or placebo taken orally twice a day. Part A of the study administers 40 mg of golexanolone twice daily for 5 days to assess safety, tolerability, and pharmacokinetics. Part B involves treatment with two dose levels of golexanolone or placebo twice daily for 28 days to evaluate safety, tolerability, and effects on quality of life and cognitive symptoms. Throughout the study, participants are monitored for adverse events from baseline to the end of each treatment period (5 days for part A and 28 days for part B). Researchers assess safety and tolerability, cognitive function, fatigue, daytime sleepiness, and overall treatment effects. Participants must provide informed consent and be able to participate in evaluations during the treatment periods.

Researchers are investigating how anti-inflammatory nutrition might affect the outcomes of non-surgical periodontal treatment in people with periodontitis. The study will assess various biomarkers found in gingival crevicular fluid and blood serum, along with clinical periodontal signs, to understand inflammation and healing. The goal is to see if education about anti-inflammatory diets can help improve treatment success and reduce gum inflammation in individuals with a pro-inflammatory diet. A total of 100 participants with periodontitis and a diet classified as pro-inflammatory will be divided into four groups based on diet score and whether they receive anti-inflammatory nutrition education. All participants will undergo non-surgical periodontal treatment. Two groups will also receive education on anti-inflammatory nutrition while the other two groups will only receive the periodontal treatment. The groups are monitored at baseline, 1.5 months, and 3 months after treatment. During the study, researchers will collect samples of gingival crevicular fluid and blood serum, measure clinical periodontal parameters, and calculate the Dietary Inflammatory Index at three time points: before treatment, 1.5 months after, and 3 months after treatment. They will analyze levels of specific inflammatory and oxidative stress markers such as interleukins, tumor necrosis factor, total oxidant and antioxidant status, and C-reactive protein. This detailed monitoring aims to evaluate treatment effects and the role of diet in periodontal health over the study period.

Researchers are investigating how nutrition affects periodontal (gum) health in people diagnosed with obesity who do not have other systemic diseases. The study also explores the relationship between the Dietary Inflammatory Index (DII), which measures diet's inflammatory potential, and the risk of periodontal disease. A total of 200 participants will be divided into four groups based on their DII scores, ranging from low (anti-inflammatory diet) to high (pro-inflammatory diet). Various biomarkers related to inflammation and oxidative stress will be measured from blood and gum fluid samples. Periodontal health measures, including periodontal pocket depth and clinical attachment loss, will be collected from all participants. Serum and gingival crevicular fluid samples will also be obtained to analyze inflammatory markers like interleukins, tumor necrosis factor, C-reactive protein, and antioxidant status using laboratory tests. Participants will be categorized into four groups according to their DII scores: Q1 and Q2 (lower scores representing an anti-inflammatory diet) and Q3 and Q4 (higher scores representing a pro-inflammatory diet). Participants will undergo periodontal assessments and provide blood and gum fluid samples for laboratory analysis. Researchers will measure periodontal pocket depth and attachment loss at baseline, and examine biomarkers from the collected samples. The study will monitor these clinical and biochemical markers to understand the link between diet-induced inflammation and periodontal health among obese individuals. The study includes adults aged 18 to 65 years who meet specific health and lifestyle criteria.

Intervention Protocol: Experimental Group: In addition to routine delivery care, newborns will receive Kangaroo Mother Care (KMC). The newborn, wearing only a diaper and a hat, will be placed in an upright "chest-to-chest" position on the mother's bare chest. The infant's head will be maintained in a neutral physiological position, and the back will be covered with a blanket. This intermittent KMC application will be initiated following the first breastfeeding attempt and maintained throughout the first 24 hours postpartum, including during transport and periods of maternal rest. Control Group: Participants will receive the standard hospital protocol (routine skin-to-skin contact immediately after birth and standard neonatal care). No additional KMC intervention will be applied by the study team. Data Collection and Measurement Points:Data collection will be conducted at two specific time points to evaluate the effectiveness of the intervention:Baseline (0 Hour): Immediately following the first breastfeeding attempt (within the first hour postpartum), the LATCH Breastfeeding Assessment Tool will be administered to both groups to establish baseline breastfeeding success.Post-Intervention (24th Hour): At the end of the 24th hour postpartum, the LATCH tool will be re-administered to evaluate the change in breastfeeding success. Additionally, the Semantic Differential Scale-Myself as a Mother will be administered at this time point to compare maternal role perception between the two groups. Statistical Analysis: The normality of the data will be assessed using the Skewness and Kurtosis coefficients. For Breastfeeding Success: A Two-Way Mixed ANOVA will be used to analyze the interaction between "Group" (Experimental vs. Control) and "Time" (0 vs. 24 hours).For Maternal Role Perception: Since this variable is measured only at the 24th hour, an Independent Samples t-test (or Mann-Whitney U test, depending on normality) will be used for inter-group comparison.All analyses will be performed using SPSS 25.0 with a significance level of p \< 0.05.

Researchers are evaluating the effects of survodutide in adults aged 18 years and older who have a confirmed liver condition called non-alcoholic steatohepatitis (NASH) or metabolic-associated steatohepatitis (MASH). Eligible participants must have a body mass index (BMI) of 27 kg/m2 or higher, or at least 25 kg/m2 if they are Asian. The study excludes those with other chronic liver diseases or a history of significant alcohol use. The main goal is to see if survodutide can improve liver function and delay progression of liver damage over time. Participants are randomly assigned to receive either survodutide or a placebo, with twice the chance of receiving survodutide. Both treatments are given as weekly injections under the skin using a pre-filled syringe. Alongside treatment, all participants receive regular counseling to encourage healthy diet and exercise habits. The study lasts up to four and a half years, with frequent visits or remote video calls during the first year and five months, then quarterly visits thereafter. During the study, doctors monitor participants' health, including body weight and liver function using imaging tests at certain visits. Participants complete symptom questionnaires to help assess their condition. Researchers track outcomes such as survival, need for liver transplant, worsening liver disease, and liver-related complications. Safety and any side effects are closely watched throughout the study period to understand the treatment's impact.