Zonguldak Merkez

Researchers are evaluating the safety and effectiveness of SAR441566 in adults with moderate to severe Crohn's Disease in this phase 2, multinational, randomized, double-blind, placebo-controlled study. The main goal is to compare different doses of SAR441566 against a placebo to see how well they work in treating Crohn's Disease. The study involves participants who have had a confirmed diagnosis of Crohn's Disease for at least three months and have shown moderate to severe symptoms. Participants will take either SAR441566 tablets or matching placebo tablets orally during the study. The study begins with a 4-week screening period, followed by a 52-week main treatment phase that includes 12 weeks of induction treatment and 40 weeks of maintenance treatment under double-blind conditions. After this, a 2-week follow-up is conducted for those not entering the long-term safety study. Eligible participants may join an open-label phase lasting up to 40 weeks, but the combined time in maintenance and open-label phases will not exceed 40 weeks. During the study, participants will undergo assessments including endoscopy to measure response at week 12. Researchers will monitor symptoms, stool frequency, and abdominal pain scores to evaluate treatment effects. Safety will be tracked throughout the study, including a follow-up after treatment ends. The total study duration for participants can be up to 59 weeks, with careful monitoring to ensure accurate evaluation of SAR441566's impact on Crohn's Disease.

Researchers are studying an experimental drug called odronextamab in combination with lenalidomide for adults with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL), which are subtypes of Non-Hodgkin's lymphoma. This Phase 3 study has two parts: Part 1 focuses on the safety and tolerability of this drug combination and determining the appropriate odronextamab dose, while Part 2 compares the effectiveness of this combination to the current standard treatment of rituximab plus lenalidomide. The study also explores side effects, drug levels in the blood, antibody development against the study drug, and impacts on quality of life and daily activities. Participants receive either odronextamab plus lenalidomide or rituximab plus lenalidomide according to the study protocol. Part 1 is not randomized, focusing on safety and dose finding, while Part 2 is randomized and controlled to assess efficacy and safety. Treatments are administered per protocol guidelines during these study phases. During the study, participants undergo regular evaluations including imaging scans to measure disease, blood tests, and monitoring for side effects up to two years. The main outcomes measured include dose-limiting toxicities within 35 days, treatment-emergent adverse events over two years, and progression-free survival over five years. Participants are also monitored for quality of life and ability to perform daily activities throughout the trial duration.

Researchers are evaluating an experimental drug called odronextamab for adults with previously untreated follicular lymphoma, a type of non-Hodgkin lymphoma. This Phase 3 study aims to assess the safety, tolerability, and effectiveness of odronextamab alone and compared to the current standard treatments, including rituximab combined with different types of chemotherapy. The study also examines side effects, drug levels in the blood, antibody responses against odronextamab, and the impact on quality of life and daily activities. The study consists of two parts: Part 1 is non-randomized and focuses on the safety and tolerability of odronextamab given alone. Part 2 is randomized and controlled, comparing odronextamab to rituximab combined with chemotherapy regimens such as CHOP, CVP, or Bendamustine-containing therapies. All treatments are administered according to the study protocol. Participants receive these treatments to evaluate how well odronextamab works versus standard care. Participants will undergo various assessments including imaging scans like CT or MRI to measure disease, blood tests to monitor bone marrow and liver function, and evaluations of side effects up to two years. Researchers will track dose-limiting toxicities within 35 days and assess complete response rates over 30 months. Safety and side effects will be monitored continuously, and quality of life will also be evaluated. The total length of participation depends on treatment and follow-up schedules defined in the protocol.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

This research aims to assess the effects of dual-task exercises, which combine physical and cognitive activities, delivered via telerehabilitation on balance, fall risk, cognitive functions, and sleep quality in older adults aged 65 to 74. Aging often leads to balance problems, higher fall risk, cognitive decline, and poor sleep, all of which reduce life quality and independence. Telerehabilitation offers a remote and accessible way to provide rehabilitation, especially for those with limited mobility, by using digital communication technologies to deliver care at home. Participants are divided into two groups. One group performs home-based dual-task exercises three times per week over four weeks via video calls with a physiotherapist. Each session includes warm-up, 50 minutes of combined balance/posture and cognitive tasks, and cool-down, with increasing difficulty and individual intensity adjustments. The other group receives an educational brochure and weekly phone follow-ups, performing exercises independently without video sessions. During the study, researchers will evaluate balance, fall risk, fear of falling, cognitive function, gait performance, and sleep quality at the start, after four weeks, and one month later. Assessments include physical tests and questionnaires, while physiotherapists monitor exercise form and safety remotely. The study runs from February 2, 2026, to June 2, 2026, aiming to improve functional recovery and safe mobility in elderly individuals through accessible telerehabilitation programs.

Researchers are evaluating how a digital game based on a behavioral model affects metabolic control, self-confidence, and quality of life in children aged 8 to 13 with Type 1 Diabetes. This randomized controlled trial includes children diagnosed with Type 1 Diabetes for at least 6 months, followed at pediatric endocrinology clinics in two hospitals. The study aims to understand whether this interactive digital tool can support diabetes management and improve wellbeing in young patients. Participants are randomly assigned to either an experimental group or a control group. The experimental group receives standard diabetes education followed by access to a specially designed digital game based on the Information-Motivation-Behavioral Skills Model. Children in this group engage with the game actively for 9 weeks, with weekly reminders if needed, to complete all game stages. The control group receives weekly web-based sessions with visual slides about nutrition, exercise, and medication, monitored for completion and reminded weekly if sessions are missed. After 12 weeks, all participants complete follow-up assessments. Children and their families provide data through online questionnaires at the start and at 12 weeks, including quality of life and self-efficacy scales for Type 1 Diabetes. Routine blood tests such as HbA1c are collected from hospital records at baseline and after 12 weeks. Researchers track participation closely and assess changes in metabolic control, self-management confidence, and quality of life. After study completion, the control group is also offered access to the digital game to ensure ethical fairness.

Researchers are evaluating the effect of placental cord drainage on the third stage of labor and postpartum bleeding in women. This stage, though short, carries risks such as postpartum hemorrhage if prolonged. The study focuses on whether opening the clamp at the maternal end of the umbilical cord after cutting it helps shorten the third stage, reduce blood loss, and lower postpartum complications. Previous studies have shown mixed results, making further investigation important for improving labor management and outcomes. The study compares two groups of women during labor: one group receives placental cord drainage where the clamp on the umbilical cord is opened after cutting to allow blood flow from the placenta, and the other group follows routine care with the cord remaining clamped until placenta delivery. All participants receive standard prophylactic treatment with medication. Placental drainage continues until signs of placental separation appear or for a maximum of five minutes. Placental delivery is assisted by controlled cord traction in both groups. Blood loss is measured by collecting drainage and postpartum bleeding with precise scales and devices. Participants are monitored throughout labor and for two hours after delivery, with vital signs, uterine tone, and bleeding carefully assessed. Pain levels, breastfeeding initiation, and postpartum complications are recorded. Blood counts are checked 24 hours after birth. Data collection includes timing each labor stage, measuring blood loss, and assessing placental condition. Observations are made by staff unaware of group assignments to ensure unbiased results. This comprehensive approach aims to clarify the benefits and safety of placental cord drainage in reducing postpartum hemorrhage and shortening labor.