Kutahya Merkez

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating the combined use of vicadrostat and empagliflozin in adults with chronic heart failure who have a reduced left ventricular ejection fraction LVEF below 40%. Participants must have had chronic heart failure diagnosed at least three months before starting the study. The trial aims to find out if this combination helps people with symptomatic heart failure classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups, with an equal chance of receiving either vicadrostat plus empagliflozin tablets or placebo plus empagliflozin tablets. The study medicines are taken once daily for approximately six months up to about 3.5 years. During this time, participants may continue their usual heart failure treatments, excluding certain medications. The trial includes a double-blind design, meaning neither participants nor study staff know who receives the active drug or placebo. Throughout the study, participants visit the study site regularly, with the number of visits depending on how long they stay enrolled. Some visits may occur by phone. They answer questions about their well-being, and doctors monitor health status, record any heart failure worsening, hospitalizations, or deaths. The main outcome is the time until cardiovascular death, heart failure hospitalization, or urgent heart failure visit, which is compared between groups. Safety and side effects are also closely followed during the trial.

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are evaluating the effects of autogenous grafts taken from different palatal regions on the tissue around dental implants during second-stage implant surgery. The study aims to compare how these grafts affect the width and thickness of the peri-implant mucosa, including tissue health and patient satisfaction. This evaluation involves clinical, radiographic, and digital methods to understand early effects on peri-implant soft tissue management. Participants are randomly assigned to one of two groups one receiving grafts including marginal and interdental palatal gingiva, and the other receiving grafts harvested about 1.5 mm apical to the palatal gingival margin. These grafts are applied during the second-stage implant surgery. The study uses a double-blind design to compare these two grafting techniques and their impact on the peri-implant mucosa. Participants will undergo assessments before implant placement, at the second-stage surgery 3 months, 6 months after implant placement, and 12 months after prosthetic loading. Evaluations include mucosal thickness and width, vestibular depth, plaque and bleeding indices, probing depth, mucosal recession, bone level, esthetic scores, pain, analgesic use, patient satisfaction, esthetic outcome, and oral health quality of life. The study involves clinical visits and monitoring of tissue changes and patient-reported outcomes over about one year after implant loading.

Researchers are evaluating two measures to improve the surgical field during vaginal natural orifice transluminal endoscopic surgery vNOTES hysterectomy, a procedure performed entirely through the vagina without abdominal incisions. The study is a randomized trial using a 2x2 factorial design to test whether a preoperative low-residue diet for three days, deeper intra-operative muscle relaxation deep neuromuscular blockade, or their combination improve visualization by reducing bowel interference. This trial focuses on benign gynecological conditions such as uterine leiomyoma, abnormal bleeding, uterine prolapse, and adenomyosis. Participants are assigned equally to one of four groups no diet with standard relaxation, diet with standard relaxation, no diet with deep relaxation, or diet with deep relaxation the bundle. Deep neuromuscular blockade is maintained by continuous rocuronium infusion, while standard relaxation uses intermittent rocuronium boluses both groups receive reversal with sugammadex before extubation. The low-residue diet restricts fiber intake to less than 10 grams daily for three days before surgery, avoiding raw fruits, vegetables, legumes, nuts, and seeds but allowing refined grains and cooked foods. No mechanical bowel preparation is used in any group. During surgery, the surgical field is assessed objectively by lowering carbon dioxide insufflation pressure stepwise from 12 to 6 mmHg while blinded assessors score video clips for field adequacy. Researchers measure the lowest pressure at which the surgical field remains adequate as the primary outcome. Secondary measures include continuous field scores, need for additional instruments, postoperative nausea and vomiting, operative time, blood loss, and complications. Participants are monitored during surgery and up to 24 hours postoperatively, with full neuromuscular recovery confirmed before extubation.

Researchers are evaluating the use of drug-coated balloons DCBs in treating various types of coronary artery disease, including in-stent restenosis, small vessel disease, de novo lesions, chronic total occlusions, and bifurcation lesions. This observational registry aims to gather real-world data on the safety, feasibility, and clinical outcomes of DCB angioplasty across diverse coronary lesion types and patient presentations in Turkey. The study seeks to provide comprehensive evidence beyond traditional uses, addressing both short- and long-term success rates. The study includes patients undergoing percutaneous coronary intervention PCI where DCBs are used either alone or with bailout stenting. Detailed information about patient demographics, clinical history, angiographic and procedural details, lesion preparation methods, intravascular imaging, and DCB characteristics will be collected. The registry will analyze procedural success and clinical outcomes such as major adverse cardiovascular events and need for further revascularization, focusing also on the role of lesion preparation and imaging guidance. Participants will be followed for at least 12 months, with data collected on death, revascularization of target lesions and vessels, myocardial infarction, bleeding events, and procedural success. Researchers will monitor clinical progress, collect angiographic and procedural data, and evaluate outcomes to identify factors influencing success or failure of DCB use. This study reflects routine clinical practice and aims to inform future randomized trials comparing DCB strategies with drug-eluting stents.

This research aims to determine how bathing affects physiological measures such as heart rate, body temperature, oxygen levels, skin condition, bilirubin levels, and comfort in newborn infants receiving phototherapy for jaundice. Phototherapy is the common treatment for neonatal jaundice, which occurs frequently in newborns and can lead to serious complications if untreated. The study explores whether bathing before phototherapy can reduce side effects like skin rashes and improve infant comfort. The study compares two groups of newborns those who receive a bathtub bath before phototherapy and those who receive standard care without additional bathing. Phototherapy treatment involves exposing infants to light to lower bilirubin in the blood. The bathing method studied involves using a baby bathtub and baby shampoo. The experimental group gets the bath before starting phototherapy, while the control group follows routine care without extra intervention. Participants will be monitored with multiple assessments including heart rate, respiratory rate, body temperature, oxygen saturation, skin moisture, and skin condition scores at several time points before and after bathing or phototherapy treatment. Bilirubin levels will be measured before treatment and 24 hours after phototherapy begins. Comfort levels will also be evaluated at set intervals. The study runs from hospitalization through six hours post-intervention, with detailed physiological and skin condition tracking to assess the effects of bathing on infants receiving phototherapy.

This research investigates how motor imagery training affects pain, function, proprioception, and fear of movement in adults with partial rotator cuff tears. The study compares motor imagery training combined with traditional physiotherapy to traditional physiotherapy alone. The rotator cuff muscles stabilize the shoulder joint, and partial tears can cause pain, movement limits, and muscle weakness. Motor imagery involves mentally simulating movements without physical action and may help improve motor skills and treatment outcomes. Participants are assigned randomly to one of two groups a traditional physiotherapy group or a motor imagery training group. Traditional physiotherapy includes heat application, electrical stimulation, ultrasound, stretching, and strengthening exercises over 20 sessions across 4 weeks. The motor imagery group performs the same exercises combined with kinesthetic and visual motor imagery exercises, with relaxation and attention-enhancing techniques. Imagery is monitored through heart rate, and audio commands guide the sessions. Participants will be evaluated before starting treatment, after 4 weeks of training, and at an 8-week follow-up. Assessments include pain measurement using a numerical scale, shoulder function with the DASH questionnaire, proprioception using an inclinometer, fear of movement via the Tampa Kinesiophobia Scale, and motor imagery ability with the Movement Imagery Questionnaire. The study includes safety and mental status checks, with involvement lasting about 8 weeks from baseline to follow-up evaluation.