Zeytinburnu

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating AZD0292, a bispecific IgG1k monoclonal antibody, for preventing exacerbations in bronchiectasis patients who are chronically colonized with Pseudomonas aeruginosa PsA. This Phase IIb study compares two dosage regimens of AZD0292 administered intravenously with placebo in participants aged 12 years and older. The study mainly focuses on non-cystic fibrosis bronchiectasis patients with frequent pulmonary exacerbations due to chronic PsA colonization, which negatively affects lung function, quality of life, and survival. Additionally, patients with cystic fibrosis bronchiectasis colonized with PsA are included as an exploratory group. Participants will receive either high-dose or low-dose AZD0292 starting on Day 1 via IV infusion, or placebo administered similarly. Subsequent doses will follow a schedule of assessments. This randomized, double-blind, placebo-controlled, parallel study aims to assess the efficacy, safety, and pharmacokinetics of AZD0292 over a variable follow-up period ranging from a minimum of 28 weeks up to 52 weeks. The trial also includes monitoring for adverse events and immune responses to the treatment. During the study, participants will undergo evaluations including lung function tests, quality of life questionnaires, and monitoring of exacerbation rates. Blood samples will be collected to measure drug concentration and antibody development. Safety assessments will continue through the treatment period and for up to 24 weeks after the last dose. The primary outcome is the annualized rate of exacerbations over the follow-up time, and secondary measures include severe exacerbation rates, time to first exacerbation, and changes in quality of life scores. Total participation spans from screening through the treatment and follow-up phases.

Researchers are evaluating the effects of NNC0487-0111 in adults with excess body weight and obstructive sleep apnea who are not using positive airway pressure treatment. This Phase 3 trial aims to assess the safety and effectiveness of this medication in helping participants lose weight and improve their sleep apnea. The study compares NNC0487-0111 with a placebo, which is an inactive treatment given by chance to participants. Participants receive weekly injections of either NNC0487-0111 or a matching placebo under the skin using pre-filled pen injectors applied to the thigh, abdomen, or upper arm. Both groups follow a reduced-calorie diet and increase physical activity during the study. The treatment period lasts for 80 weeks, during which researchers monitor changes in body weight and sleep apnea severity. Throughout the study, participants undergo regular assessments including body weight measurements and evaluation of the apnea-hypopnea index AHI to track sleep apnea severity. Additional tests measure sleep-related impairment, blood pressure, cholesterol levels, and blood sugar control. Safety is monitored by tracking any adverse events during the 84 weeks of the study. Participants progress is carefully followed to understand the impact of the treatment on weight and sleep apnea over time.

Researchers are evaluating the effectiveness and safety of NNC0487-0111 in adults with overweight or obesity who also have obstructive sleep apnoea and are being treated with positive airway pressure. This phase 3 study compares NNC0487-0111 to a placebo, which contains no active medicine, to see how well the treatment helps with weight loss and improvement in sleep apnoea symptoms. Participants will receive one of two dose levels of NNC0487-0111 or a matching placebo as weekly injections under the skin. These injections are given alongside a reduced-calorie diet and increased physical activity. The treatment is administered using pre-filled pen injectors to the thigh, abdomen, or upper arm, and the study lasts for 80 weeks. Throughout the trial, participants will be monitored regularly to assess changes in body weight, sleep apnoea severity measured by the apnoea-hypopnoea index AHI, and other health measures such as waist and neck circumference, blood pressure, cholesterol, blood sugar, and sleep quality scores. Safety is tracked by recording any treatment-related adverse events. The study runs until week 80, with follow-up continuing through week 84 to evaluate ongoing safety and effectiveness.

Researchers are evaluating the effectiveness and safety of MB-CART2019.1 compared to standard treatments in adults with relapsed or refractory diffuse large B-cell lymphoma DLBCL who are not eligible for intensive chemotherapy and stem cell transplantation. The study is a pivotal Phase II randomized, multi-center, open-label trial with two parts Part I compares MB-CART2019.1 to standard therapy, while Part II evaluates MB-CART2019.1 alone in younger, fitter patients. MB-CART2019.1 is a genetically modified T-cell therapy designed to target malignant B cells in advanced blood cancers. Participants in Part I are randomly assigned to receive either a single infusion of MB-CART2019.1 following lymphodepleting chemotherapy or standard of care SoC therapy, which includes regimens like R-GemOx or BR plus polatuzumab vedotin. Patients undergo leukapheresis to collect T cells for MB-CART2019.1 production. Those in the SoC arm may later receive MB-CART2019.1 if certain disease progression criteria are met. Part II will enroll younger participants to receive MB-CART2019.1 alone after Part I enrollment completes. Participants will be involved in screening, treatment, and follow-up visits totaling about 55 weeks. Assessments include scans, laboratory tests, and evaluations of disease response and safety. Primary outcomes measure event-free survival in Part I and objective response rate in Part II, both up to 30 weeks after treatment. Secondary outcomes include progression-free survival, overall survival, and duration of response assessed up to nearly two years. Extended long-term follow-up beyond the active study period will be reported separately.

Researchers are conducting an observational study to screen adults aged 18 and over who visit hospital outpatient clinics in Turkey for malnutrition and sarcopenia risks. The study focuses on patients attending oncology, neurology, and geriatric clinics to better understand these conditions across diverse patient groups. This non-interventional, cross-sectional design means participants are observed without receiving experimental treatments. Participants are screened once during their outpatient visit without any study treatments or interventions. The study collects information on malnutrition risk, sarcopenia risk, body mass index, calf circumference, hand grip strength, biochemical parameters, healthcare use, and nutrition treatments. Data is gathered on the screening day only. During the study visit, researchers will assess physical and biochemical measures to evaluate nutrition and muscle health. Participants provide informed consent before any assessments. The study measures malnutrition and sarcopenia risks as primary outcomes on the first day and includes several secondary measures related to body composition and healthcare use. The study will continue enrolling participants until April 2027.

Researchers are evaluating the combination of pumitamig also known as BNT327 or PM8002 with standard chemotherapy docetaxel in people with advanced or metastatic Non-small Cell Lung Cancer NSCLC that has progressed after first-line chemoimmunotherapy. This Phase II, multisite, open-label study aims to assess the safety and preliminary effectiveness of this combination treatment in this patient group. The study is designed in two parts to carefully monitor safety and expand dosing if appropriate. In Part 1, up to 12 participants will receive one of two dose levels of pumitamig combined with docetaxel in a safety run-in phase. Based on safety assessments, an internal review committee will decide whether to proceed to Part 2, where up to 54 additional participants will receive the recommended dose combination. In Part 2, some participants will also provide fresh tumor biopsy samples at baseline and during treatment for further analysis. Treatment continues until disease progression, unacceptable side effects, withdrawal, death, study end, or a 2-year limit. Participants will undergo regular assessments including safety monitoring for adverse events, dose adjustments, and tumor response using standard criteria. After treatment ends, a long-term follow-up will collect information on disease progression, new cancer treatments, and survival status. The primary outcomes focus on safety and response rates, while secondary outcomes include duration of response, progression-free survival, overall survival, and pharmacokinetics of pumitamig over approximately two years.

Researchers are studying first-line treatment options for participants with non-small cell lung cancer NSCLC in this Phase 23, multisite, randomized, open-label trial. The study includes two substudies based on NSCLC histological subtypes, which have different chemotherapy standards. This design allows evaluation of pumitamig BNT327 combined with chemotherapy and other investigational agents in participants with advanced NSCLC who have not received prior systemic treatment. Participants are randomized to receive one of two dose levels of pumitamig plus chemotherapy during the Phase 2 part of each substudy. In Phase 3, an independent data monitoring committee and a blinded independent central review will oversee safety and tumor assessments. Treatments include pumitamig combined with carboplatin and either pemetrexed or paclitaxel, or pembrolizumab with the same chemotherapies as active comparators. All drugs are given by intravenous infusion. The study period for each participant may last up to 64 months. Throughout the study, participants undergo regular tumor assessments and safety monitoring, including evaluation of adverse events, response rates, progression-free survival, and quality of life using validated questionnaires. Data on dose adjustments and treatment discontinuations are collected. Follow-up continues up to five years to assess long-term outcomes and survival. Participants receive detailed evaluations to understand treatment effects and safety over time in this comprehensive lung cancer trial.

Researchers are evaluating a transdiagnostic cognitive behavioral therapy CBT protocol designed to address common features such as distress intolerance, intolerance of uncertainty, and worry that underlie various anxiety disorders. The study aims to develop this unified protocol UP in Turkish, apply it as group therapy, and assess its effect on these common features as well as symptom severity across different anxiety disorders. The research also explores whether changes in these common features can predict symptom severity levels. The study includes two groups an intervention group receiving the UP based on the CBT model and a supportive therapy group serving as a control. The UP consists of eight weekly group sessions of one and a half hours each, covering assessment, psychoeducation, emotions, thoughts, behaviors, and review, followed by a one-month follow-up session. The supportive therapy group also meets for eight weeks plus a follow-up, providing a non-directive, empathic environment without CBT interventions. Participants will complete several assessments before the first session, after the eighth session, and at the one-month follow-up. These include measures of anxiety, distress tolerance, intolerance of uncertainty, worry, metacognition, and depression. The study uses random assignment to groups and single masking. The total participation covers the 8-week intervention plus the follow-up, with evaluations focused on the effectiveness of the transdiagnostic protocol and changes in common emotional disorder features.