Trabzon Merkez

Researchers are evaluating whether retatrutide and tirzepatide can prevent major adverse liver outcomes in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized controlled trial aims to assess these treatments compared to placebo in about 4,500 adults over approximately 224 weeks. The study is sponsored by Eli Lilly and Company and focuses on liver disease progression and related health measures. Participants will be randomly assigned to receive retatrutide, tirzepatide, or placebo, all administered by subcutaneous injection. The trial includes two placebo groups corresponding to each experimental drug. After completing the main study, eligible participants may join a 2-year extension where all will receive either retatrutide or tirzepatide regardless of their initial assignment. During the study, participants may attend around 25 to 30 clinic visits for health monitoring, study procedures, and assessments of liver function and disease status. Researchers will measure the time to major adverse liver outcomes, changes in liver fibrosis scores, liver stiffness, liver fat content, liver enzyme levels, body weight, and cardiovascular events. Monitoring will continue from baseline through study completion, with detailed evaluations at multiple timepoints including week 104.

Researchers are evaluating the safety and effectiveness of several long-acting antibody treatments for adults with moderately to severely active ulcerative colitis UC. This Phase 2, multicenter platform study aims to compare multiple investigational therapies, including both single agents and combinations, to better understand their potential benefits and risks. The study is sponsored by Spyre Therapeutics, Inc. and involves adults aged 18 to 75 years with active UC confirmed by endoscopy and histology.

Researchers are investigating whether adding intismeran autogene to pembrolizumab after surgery helps people with non-small cell lung cancer NSCLC stay cancer-free longer compared to pembrolizumab with a placebo. This study focuses on participants whose tumors did not fully respond to treatment before surgery. It is a phase 3 trial aiming to evaluate treatment options for resectable stage II to IIIB N2 NSCLC patients who did not achieve a complete pathological response after neoadjuvant therapy. Participants receive neoadjuvant treatment with pembrolizumab and chemotherapy drugs such as cisplatin, carboplatin, pemetrexed, gemcitabine, or paclitaxel, given by intravenous infusion every three weeks for up to four cycles. After surgery, participants receive adjuvant treatment with pembrolizumab every six weeks combined with either intismeran autogene or placebo by intramuscular injection every three weeks, for up to seven and nine doses respectively. During the study, participants undergo treatment cycles, surgery, and follow-up assessments. Researchers evaluate disease-free survival over approximately 97 months and monitor overall survival, metastasis-free survival, quality of life, physical and role functioning, and adverse events up to around 129 months. The study includes regular evaluations and safety monitoring to understand the impact of these treatments on long-term outcomes and participant well-being.

Researchers are evaluating ibuzatrelvir, an oral medication, to determine its effectiveness and safety in adults and adolescents aged 12 years and older with COVID-19 who are not hospitalized but are at high risk for severe illness. The study is a phase 3, randomized, double-blind trial comparing ibuzatrelvir with a placebo. Participants must have confirmed SARS-CoV-2 infection with symptoms starting within 5 days and meet specific risk factor criteria based on age. Eligible participants will be randomly assigned to receive either ibuzatrelvir or a matching placebo twice daily by mouth for 5 days. The study allows co-administration of standard care treatments available locally. The total study duration is about 6 months, including follow-up. Participants will be monitored for emergency department visits related to COVID-19, hospitalizations, and mortality up to 28 days after starting treatment. Additional evaluations include symptom resolution, occurrence of long COVID symptoms, viral RNA levels, and safety measures such as adverse events through 24 weeks. The study involves regular assessments, including clinical visits and laboratory tests, to track outcomes and safety over time.

Researchers are evaluating the effects of a study medicine called ibuzatrelvir, alone and in combination with remdesivir, for treating symptomatic COVID-19 in adults who are severely immunocompromised. This Phase 3 clinical trial compares ibuzatrelvir with remdesivir to remdesivir alone to assess safety and effectiveness in non-hospitalized or hospitalized patients who do not require supplemental oxygen. Immunocompromised patients often have difficulty fighting infections and may benefit from extended or combination antiviral treatments. Participants are randomly assigned to one of three groups one receiving both ibuzatrelvir taken orally twice daily and intravenous remdesivir, one receiving ibuzatrelvir with a placebo infusion, and one receiving remdesivir with a placebo pill. Placebos that look like the study medicines are used to keep the groups similar in appearance. This design helps researchers determine if adding ibuzatrelvir improves treatment compared to remdesivir alone. Participants will attend about 10 study visits over 24 weeks, including clinic visits for blood tests, nasal swabs collected both at the clinic and at home, and questionnaires. Researchers will measure outcomes such as symptom improvement, viral levels, COVID-19-related healthcare visits, and safety events. The study carefully monitors participants throughout to understand the treatment effects and safety over time.

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 the safety, tolerability, and initial effects of two dosages of golexanolone compared to placebo in adults with Primary Biliary Cholangitis PBC who experience significant fatigue and cognitive symptoms. This phase 1b2 randomized, double-blind, placebo-controlled study focuses on patients with non-cirrhotic or mild cirrhotic PBC Child-Pugh class A who are on stable standard care medication. The study aims to understand how golexanolone affects fatigue, daytime sleepiness, cognitive function, and overall quality of life. The study has two parts Part A assesses safety, tolerability, and pharmacokinetics of golexanolone 40 mg taken twice daily for 5 days. Part B evaluates safety, tolerability, and effects of two dose levels 40 mg and 80 mg, twice daily compared to placebo over 28 days. Participants receive soft gelatin capsules orally twice daily during these periods. The study uses a parallel design with randomized allocation and quadruple masking to compare golexanolone doses and placebo. Participants will be monitored from enrollment through 5 days in Part A and 28 days in Part B, with assessments including adverse event tracking, quality of life questionnaires PBC-40, EQ-5D-3L, sleepiness scales, cognitive tests, and investigator impressions of treatment effect. Pharmacokinetic sampling occurs on days 1, 14, and 28 in Part B. Safety and tolerability are closely observed, with the total participation lasting up to 28 days depending on the part enrolled.

This research aims to evaluate the safety, performance, and usability of several Occlutech accessory medical devices used in heart disease treatment. These devices include the Occlutech Delivery Set ODS, Occlutech Pistol Pusher OPP, Occlutech Occlusions-Pusher OOP, and Occlutech Sizing Balloon OSB. The study is international, multicenter, non-randomized, and non-invasive, focusing on catheter-based implantation procedures for cardiac implants. The study involves physicians experienced in cardiac catheterization using these accessories during implantation procedures. Investigators complete detailed surveys to assess each devices safety, including success of implantation, adverse events during or after the procedure, user harm, and any device deficiencies. The surveys also evaluate the performance, usability, and compatibility of these accessories with other devices. Subjects receive treatment following standard clinical routines and specific instructions for use. Participants who have undergone implantation with an Occlutech accessory and cardiac implant are included. Researchers monitor safety events and assess device performance and usability over a 6-month period. Data is collected via investigator questionnaires, focusing on implantation outcomes and any related complications. The total participation duration varies depending on individual follow-up but includes at least 6 months of monitoring for safety and performance.

Researchers are evaluating the early prediction of muscle loss, known as sarcopenia, in intensive care patients with brain injuries. This prospective observational study focuses on adults aged 18 to 65 admitted to intensive care units with various intracranial conditions such as hemorrhages, tumors, and ischemic stroke. The study aims to compare the accuracy of different artificial intelligence models in predicting sarcopenia development by day 7 of ICU admission. Participants will be observed without any experimental treatment changes. Their rectus femoris muscle thickness will be measured using ultrasound on the day of ICU admission Day 0 and again on Day 7. Blood levels of prealbumin, a nutritional marker, will be checked on Days 0, 3, and 7. The modified Nutrition Risk in Critically Ill mNUTRIC score will be calculated on the first ICU day. These clinical, laboratory, and ultrasound data will be fed into various AI models to evaluate their prediction performance. During the study, patients will undergo routine clinical monitoring, and all data will be collected as part of standard care. Ultrasound measurements will be standardized and performed by the same investigator. Researchers will measure how accurately AI models predict muscle loss by Day 7 and compare these predictions with clinical assessments. Data privacy will be strictly maintained, with all information securely stored and de-identified. The study is planned to enroll 100 to 150 patients and run from January to August 2026.

Researchers are investigating whether patients tendency to exaggerate or focus on pain, known as pain catastrophizing, is linked to nausea and vomiting following laparoscopic gallbladder surgery. This observational study includes adult patients aged 18 to 65 who are scheduled for elective laparoscopic cholecystectomy. The goal is to better understand how psychological factors affect postoperative symptoms like nausea and vomiting, which can impact recovery and patient satisfaction. Participants will complete the Pain Catastrophizing Scale, a questionnaire measuring catastrophic thinking about pain, before surgery. They will also rate their pain during intravenous IV cannulation. After surgery, nausea and vomiting will be assessed at various points during the first 24 hours. This study uses the validated Turkish version of the Pain Catastrophizing Scale to explore the relationship between pain perception, psychological factors, and postoperative symptoms. Throughout the study, researchers will collect numeric pain scores during IV access and monitor the incidence of nausea and vomiting after surgery. These assessments will help measure the association between preoperative pain perception, pain catastrophizing levels, and postoperative symptoms. The study may support more personalized anesthesia care by highlighting the role of psychological factors in recovery after laparoscopic gallbladder surgery.