Artvin Merkez

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

Researchers are conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.

Researchers are evaluating the impact of digital parenting education on mothers' knowledge and attitudes about their children's technology use and their own social media addiction levels. This randomized controlled trial focuses on mothers with healthy preschool children aged 3 to 6 years, affiliated with family health centers under the Artvin Provincial Health Directorate. The study aims to address risks associated with uncontrolled technology use, such as screen dependency and social isolation, by promoting conscious digital behavior and safe internet practices from early childhood. Mothers in the experimental group will receive digital parenting education through eight face-to-face sessions, each lasting 20 minutes. The training covers topics including digital parenting roles, effects of information technology use on parent-child relationships and children's behavior, proper social media use, and associated opportunities and risks. Educational brochures will support learning. The control group will only complete pre- and post-test assessments and will receive educational materials after study completion. Data collection includes sociodemographic questionnaires and scales measuring parental knowledge, attitudes, and social media addiction. Participants will complete pre-test assessments face-to-face before starting the intervention, with follow-up post-test evaluations after the training sessions. Researchers will monitor changes in mothers' knowledge, attitudes, and social media addiction levels over 12 weeks. Statistical analyses will compare outcomes between groups and evaluate relationships among the measured variables. The total study duration includes the intervention and follow-up periods to assess the training's effects comprehensively.

Breast cancer is a common cancer in women, and chemotherapy is a key treatment. However, chemotherapy can cause psychological distress, anxiety, and discomfort, affecting quality of life and treatment adherence. This study evaluates whether mandala coloring during outpatient chemotherapy can reduce these negative feelings and improve comfort in breast cancer patients. The study is a randomized controlled trial conducted with 60 participants. Participants will be randomly assigned to either an intervention group or a control group. Those in the intervention group will color mandala patterns for 30 minutes at the start of their chemotherapy session using coloring books and pencils, alongside routine medical care. The control group will receive routine care only without any coloring activity. This method is being studied as a simple, low-cost supportive approach to improve patient well-being. Researchers will measure psychological distress, anxiety, and comfort before and after chemotherapy sessions in both groups. Tools such as the Distress Thermometer, State Anxiety subscale of the State-Trait Anxiety Inventory, and General Comfort Scale will be used to assess these outcomes. The study aims to provide evidence on whether mandala coloring can support breast cancer patients' psychological health during chemotherapy.

Researchers are evaluating the safety and effectiveness of a drug called Imeroprubart in adults who have Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition affecting the nerves. This Phase 2b study is conducted at multiple centers and uses a randomized, double-blind, placebo-controlled design to compare Imeroprubart with a placebo in participants with active CIDP. Participants receive either Imeroprubart or a matching placebo by subcutaneous injection once a week. The treatment is given for 24 weeks during the first period, followed by an extension period of 52 weeks for continued monitoring. Imeroprubart is dosed once weekly by injection under the skin, and the placebo group receives matching injections during the initial 24 weeks. Throughout the study, participants undergo various assessments to monitor their health and response to treatment. Researchers measure the proportion of participants who remain free from disease relapse by Week 24. Safety and efficacy are closely tracked with clinical evaluations and diagnostic tests. The total duration of participation includes the treatment periods and follow-up to observe outcomes and potential side effects.

Researchers are evaluating the effects of Laughter Yoga on sleep quality, vitality, active aging, and quality of life in individuals aged 60 and over. This study is a randomized controlled experimental trial conducted between September 1, 2024, and December 31, 2024, involving elderly individuals registered at eavfat Family Health Center No. 1. The study will examine whether Laughter Yoga can offer physical and psychosocial benefits such as improved muscle activation, reduced stress hormones, better mood, and enhanced social relationships in older adults. Participants will be randomly assigned to either an experimental group or a control group, each with 30 people. The experimental group will attend 12 Laughter Yoga sessions held twice a week for 6 weeks, with each session lasting 40 minutes. These sessions include deep breathing, clapping and warm-up exercises, childlike play, and laughter exercises led by a certified instructor. The control group will not receive any intervention during this period. All sessions will take place in a gymnasium under optimal conditions. During the study, participants will complete several assessments including the Mini-Mental State Examination, Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for the Elderly before and after the 6-week intervention. Data collection will be done through face-to-face interviews. Participants will continue their usual medications throughout the study. At the end, the control group will have the option to receive information about Laughter Yoga. The study aims to measure changes in sleep quality, vitality, active aging, and overall quality of life while monitoring safety and adherence.

Researchers are evaluating whether using a stress ball during chemotherapy can reduce anxiety, fear, and changes in vital signs in adult patients with gastrointestinal system cancers. This randomized controlled experimental trial focuses on the emotional and physiological effects of stress ball use during chemotherapy treatment at the Artvin State Hospital Chemotherapy Unit. The study aims to provide evidence for a simple, safe, and low-cost method to improve the well-being of patients undergoing chemotherapy. Participants will be randomly assigned to either an experimental group or a control group. Those in the experimental group will squeeze a medium-firm stress ball for 15 minutes starting at the beginning of their chemotherapy session, following guided breathing instructions. The control group will receive routine chemotherapy care without any additional intervention. No other behavioral or drug treatments will be applied during the sessions. Before and after chemotherapy, researchers will assess anxiety and fear levels using validated tools, and record vital signs including blood pressure, heart rate, respiratory rate, body temperature, and oxygen saturation. The primary outcome measure is the State Anxiety score before and immediately after chemotherapy. This study will compare these outcomes between the two groups to determine if stress ball use can improve emotional and physiological stability during chemotherapy.

Researchers are investigating whether carefully controlling blood pressure during surgery can reduce serious complications like heart injury, stroke, kidney damage, infections, sepsis, and death within 30 days after major non-heart-related surgery. This international randomized trial compares two approaches to managing blood pressure during surgery to test if maintaining tighter control improves patient outcomes. Participants will be randomly assigned to one of two groups. One group will receive an infusion of norepinephrine or phenylephrine to keep their mean arterial pressure (MAP) at or above 85 mmHg during surgery, with specific adjustments to anesthesia and medications to achieve this tight pressure management. The other group will receive routine blood pressure management, with medications and anesthesia given as usual without strict MAP targets. Both groups will have anesthesia and other treatments managed according to clinical judgment and standard practices. During the study, participants will be monitored for major complications within the first 30 days after surgery. Researchers will track events such as heart injury, stroke, kidney injury, infections, sepsis, and death. Blood pressure and other vital signs will be closely observed during surgery. Follow-up includes hospitalization and assessments of complications. The study aims to understand if tight blood pressure control during surgery can improve recovery and reduce serious health risks after major surgery.