Zonguldak Merkez

Researchers are evaluating an experimental drug called odronextamab combined with lenalidomide in adults who have relapsed or refractory follicular lymphoma FL or marginal zone lymphoma MZL, which are subtypes of Non-Hodgkins lymphoma. The study aims to assess the safety, tolerability, and proper dosing of this new combination and compare its effectiveness to the current standard treatment of rituximab combined with lenalidomide. The research also explores side effects, drug levels in the blood, immune responses to the drug, and impacts on quality of life and daily functioning. The study has two parts Part 1 is a safety phase where all participants receive odronextamab plus lenalidomide to determine the appropriate dose. Part 2 is randomized and compares two groupsone receiving odronextamab with lenalidomide, and the other receiving rituximab with lenalidomide followed by lenalidomide alone. Participants receive these treatments according to the study protocol during these phases. Throughout the study, participants will undergo various assessments including safety monitoring for side effects, measurement of drug concentrations and immune responses, imaging scans to evaluate disease status, and quality-of-life questionnaires. The primary outcomes include tracking dose-limiting toxicities up to 35 days and treatment-emergent adverse events up to 2 years. Longer-term outcomes such as progression-free survival and overall survival will be followed for up to 5 years, with ongoing evaluations to understand the treatments impact over time.

Researchers are studying an experimental drug called odronextamab for adults with previously untreated follicular lymphoma, a type of non-Hodgkin lymphoma. The trial is a Phase 3, open-label, randomized study comparing odronextamab to rituximab combined with different chemotherapy regimens, which represent the current standard treatment. The study aims to evaluate the safety, tolerability, and how well odronextamab works compared to standard care, including side effects, drug levels in the blood, antibody development against the drug, and quality of life impacts. The study has two parts Part 1 is a non-randomized safety run-in where all participants receive odronextamab alone to assess safety and tolerability. In Part 2, participants are randomly assigned to one of two groups one receiving odronextamab followed by maintenance therapy with odronextamab, and the other receiving rituximab combined with chemotherapy followed by rituximab maintenance. Chemotherapy regimens include CHOP, CVP, or bendamustine, administered as per protocol. Participants will be monitored regularly for treatment side effects, drug concentrations, and immune responses for up to 5 years. Researchers will assess responses using imaging and other tests at multiple time points, including complete response at 30 months and progression-free survival up to 5 years. Quality of life and physical function will also be evaluated using standardized questionnaires. Safety and adverse events will be tracked for up to 2 years, ensuring comprehensive follow-up throughout the study duration.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are investigating how dual-task exercises, which combine physical and cognitive activities, delivered through telerehabilitation, affect balance, fall risk, cognitive functions, and sleep quality in older adults aged 65 to 74 years. Aging often leads to balance problems, higher fall risk, cognitive decline, and poor sleep, all impacting quality of life. This study explores whether remote dual-task training can improve these issues and support safer, more independent living for geriatric individuals. Participants are randomly assigned to one of two groups. The telerehabilitation group performs supervised dual-task exercises at home three times a week for four weeks via video calls with a physiotherapist. Each 60-minute session includes warm-up, combined motor and cognitive tasks targeting balance, posture, and mental functions, and cool-down. The control group receives an educational brochure covering posture, balance, sleep hygiene, and safe activity, with weekly phone calls to encourage adherence but no supervised sessions. Throughout the study, researchers assess participants balance, fall risk and fear, sleep quality, gait, functional mobility, mental state, and cognitive function at the start, after four weeks, and one month later. The physiotherapist monitors exercise form and safety during sessions. This approach aims to provide accessible, remote rehabilitation to improve physical and cognitive health in older adults while reducing barriers to care. The study runs from February to June 2026 with follow-up assessments after completion.

Researchers are evaluating the effect of a model-based digital game on metabolic control, self-efficacy, and quality of life in children with type 1 diabetes T1DM. This randomized controlled trial includes children aged 8 to 13 diagnosed with T1DM who are followed in pediatric endocrinology clinics. The study aims to compare the digital game intervention to standard diabetes education to see if it improves these outcomes. The study involves two groups an experimental group that receives standard diabetes education followed by participation in a digital game based on the Information-Motivation-Behavioral Skills Model for diabetes management, and a control group that receives standard diabetes education and weekly visual slide sessions on nutrition, exercise, and medication use. The digital game participation lasts 9 weeks, with active monitoring and weekly reminders for incomplete stages. Both groups complete questionnaires and scales at the start and again at 12 and 15 weeks. After the study, the control group will also have access to the game. Participants will complete several questionnaires online, including the Quality of Life Scale for Children with Type 1 Diabetes and the Diabetes Management Self-Efficacy Scale. Routine blood tests such as HbA1c will be collected from hospital records at the start and after 12 weeks. Researchers will monitor participants engagement with the game or educational sessions and use these measures to assess outcomes. The total study duration includes baseline, 9 weeks of intervention, and follow-ups at 12 and 15 weeks.

The trial investigates the effect of controlled placental cord drainage on the third stage of labor and postpartum bleeding in women. It focuses on how this method, involving opening the clamp at the maternal end of the umbilical cord after cutting, may influence the duration of placental delivery, blood loss during the third stage and the second hour postpartum, and the risk of postpartum complications. The study addresses conflicting previous findings and aims to clarify whether placental cord drainage can safely shorten labor and reduce bleeding. Participants are randomly assigned to one of two groups an intervention group where the clamp on the maternal end of the umbilical cord is opened to allow placental blood to flow out until signs of placental separation appear, and a control group where the cord remains clamped until placental delivery. Both groups receive standard prophylactic treatment with synpitan, and the placenta is delivered using controlled cord traction. The intervention procedure lasts up to five minutes unless earlier placental separation signs are seen. During the study, researchers will monitor labor stages, measure blood loss using collection devices and scales, and record the duration of the third stage of labor. Vital signs, uterine tone, and postpartum complications are assessed, with follow-up including hemoglobin and hematocrit levels 24 hours after birth. Breastfeeding initiation and duration are also tracked. Monitoring continues for two hours postpartum to evaluate safety and outcomes related to blood loss and labor progress.