Trabzon Merkez

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 studying the safety and effectiveness of long-acting antibodies given alone or in combinations to adults with moderately to severely active ulcerative colitis (UC). This Phase 2, multicenter platform trial aims to find treatments that can improve symptoms and induce remission in people diagnosed with UC for at least 3 months. The study includes participants with active disease confirmed by endoscopy and histology and with moderate to severe symptoms based on a scoring system. The trial has two parts. Part A is an open-label phase testing three different monotherapy drugs to assess safety and initial effectiveness. Part B will be a randomized, placebo-controlled phase where participants receive one of six interventions (three monotherapies or three combinations) or placebo to compare outcomes. Treatments involve intravenous (IV) induction followed by subcutaneous (SC) maintenance dosing. Different treatment arms may start and finish at varying times during the study. Participants will undergo endoscopy and histology to confirm disease activity at screening, with regular monitoring throughout the study. Researchers will evaluate changes in disease severity using the Robarts Histopathology Index and measure the percentage of participants achieving clinical remission by Week 12. Safety and efficacy will be closely followed during and after treatment. The total study duration depends on treatment arm timelines and follow-up requirements.

Researchers are evaluating whether adding intismeran autogene to pembrolizumab after surgery can help people with non-small cell lung cancer (NSCLC) remain cancer-free longer compared to pembrolizumab with a placebo. This study focuses on patients with NSCLC whose tumors did not completely respond to treatment before surgery and aims to prevent the cancer from returning. It is a Phase 3 randomized, double-blind study involving participants with resectable Stage II to IIIB (N2) NSCLC. Participants receive treatments including pembrolizumab given as an intravenous infusion and either intismeran autogene or placebo administered as an intramuscular injection. Before surgery, patients have received neoadjuvant pembrolizumab combined with platinum-based doublet chemotherapy, but only those who did not achieve a complete pathological response are eligible. The study compares the effects of pembrolizumab with or without intismeran autogene following surgery. During the study, participants are closely monitored for disease-free survival over a period of up to approximately 97 months. Researchers will assess whether the cancer returns and evaluate overall safety. Participants undergo regular evaluations including clinical assessments and laboratory tests to monitor their health and treatment response throughout the study period.

Researchers are evaluating the efficacy and safety of verekitug (UPB-101) in adults with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), a long-term inflammatory lung condition. This global, multicenter Phase 2b study aims to understand how well verekitug works compared to a placebo, alongside participants' usual COPD medications. Participants must have a confirmed COPD diagnosis and meet specific lung function and symptom criteria to join the study. Participants will be randomly assigned to receive one of two doses of verekitug or a matching placebo, in addition to their regular COPD background treatments. The study includes a screening period of about 4 weeks, followed by treatment lasting between 60 and 108 weeks. After treatment, there is a 16-week follow-up period to monitor participants after their last dose. Throughout the study, participants will undergo various assessments including lung function tests and symptom evaluations. Researchers will track the annual rate of moderate or severe COPD flare-ups from the start of treatment through week 108. Safety and tolerability will be closely monitored during the treatment and follow-up periods to ensure participants' well-being over the course of the trial.

The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

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.

This research aims to evaluate the safety, performance, and usability of Occlutech accessory medical devices used in cardiac implant procedures. It is an international, multicenter, non-randomized, non-invasive registry study focusing on devices such as the Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP), Occlutech Occlusions-Pusher (OOP), and Occlutech Sizing Balloon (OSB). The study collects data through investigator-completed surveys to monitor device-related outcomes during and after catheter-based cardiac implant interventions. The study involves the use of the specified Occlutech accessory devices by experienced physicians skilled in cardiac catheterization and interventional operations. Investigators complete detailed questionnaires assessing the success of implantation procedures, any adverse events occurring during or after the procedures, user harm related to the accessories, and any device deficiencies. The surveys also evaluate performance, usability, and compatibility of the accessories with other devices. Participants are treated following the implants' and accessories' instructions for use and standard clinical practice. Participants' involvement includes undergoing implantation procedures with these accessory devices, after which investigators collect data via surveys. The study monitors safety events over six months, including any adverse outcomes linked to the accessories or procedures. The collected information helps assess the devices' safety profile and practical use in real-world clinical settings. The total duration of monitoring and follow-up is six months per participant to capture both immediate and longer-term effects.

This research aims to find out how well certain body measurements like height, sex, weight, and BMI can predict the size of tendons used for anterior cruciate ligament (ACL) reconstruction surgery. The study focuses on two types of tendon autografts, the full-thickness peroneus longus and semitendinosus, to see if preoperative measurements can help estimate their dimensions before surgery. Participants will undergo ACL reconstruction surgery using either the semitendinosus tendon or the peroneus longus tendon as an autograft. Researchers will collect various data including age, sex, height, weight, BMI, and specific limb measurements such as cruris length and circumference, as well as thigh length and circumference. During surgery, details about the tendon type, tendon length, graft length, and graft diameter will be recorded to compare with the preoperative measurements. Participants will be assessed through preoperative imaging confirming ACL rupture and measurements of their limbs. The main outcome measured is the correlation between these preoperative anthropometric variables and the intraoperative tendon and graft sizes. This data will help determine how well body measurements predict tendon sizes used in ACL reconstruction surgery. The study involves adults aged 18 to 45 years and includes monitoring for eligibility regarding tendon harvesting and absence of prior surgeries or injuries on the donor site.

This research investigates the relationship between traditional markers used to predict difficult airway management in obese patients and new ultrasonographic measurements. The study focuses on obese adults undergoing elective surgery under general anesthesia, aiming to compare how well these markers predict difficult intubation. It also examines how different laryngoscopy methods affect intubation success, respiratory complications during surgery, and hemodynamic responses to intubation. Participants will receive preoperative airway ultrasonography to assess upper airway structures using a specialized ultrasound device. They will be randomly assigned to intubation using one of three laryngoscopy devices: the Macintosh direct laryngoscope, Tuoren videolaryngoscope, or Besdata videolaryngoscope. Ultrasonography will be repeated 30 minutes after surgery to check for airway-related complications. The surgeries will last between 60 and 150 minutes under standardized general anesthesia. During the study, researchers will collect detailed patient information including demographics, medical history, and airway assessment scores. They will monitor intubation times, glottic visualization, need for assistance, and complications. Outcome measures include predicting difficult intubation and success rates by laryngoscope type. The study also evaluates postoperative airway status and tracks hemodynamic changes during intubation to better understand the safety and effectiveness of each laryngoscopy method in obese patients.