Yenimahalle

Researchers are investigating the safety and effectiveness of efruxifermin in people with non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis (stage 2 or 3). This Phase 3 study is randomized, double-blind, and placebo-controlled, enrolling a total of 1650 participants in two groups to evaluate treatment outcomes. Participants will receive either efruxifermin or a placebo by subcutaneous injection. The study involves two cohorts, with Cohort 1 including patients who have biopsy-confirmed NASH or MASH and specific liver fibrosis and activity scores. The treatment period and detailed dosing schedules are not provided but the study compares the effects of the active drug against placebo. During the study, participants will be monitored for improvement in liver disease status, including resolution of NASH/MASH and at least a one-stage improvement in liver fibrosis after 52 weeks for Cohort 1. Long-term outcomes such as event-free survival will be observed over 240 weeks. Safety and efficacy assessments will be conducted throughout the study period, including evaluations of liver histology and metabolic health.

Researchers are evaluating the efficacy and safety of Kedrion Intravenous Human Normal Immunoglobulin 10% (IVIg 10%) in adult patients with chronic primary Immune Thrombocytopenia (ITP), a condition characterized by low platelet counts lasting over 12 months. This Phase III, open-label, single-arm, multicenter study focuses on adults aged 18 to 70 years with chronic ITP and low platelet levels, aiming to assess the treatment's response rate by day 14. The study involves administering Kedrion IVIG 10% intravenously to eligible patients. Participants will receive the treatment following screening and baseline assessments, with careful monitoring of platelet counts and health status. The protocol includes specific criteria for inclusion and exclusion to ensure patient safety and appropriate evaluation of the therapy. During the study, participants will undergo regular assessments including platelet counts, safety evaluations, and monitoring for any adverse effects. Researchers will measure the rate of patients who respond to treatment by day 14. The study also requires adherence to protocol guidelines, pregnancy testing for women of childbearing potential, and use of birth control during the trial. The total participation period covers screening, treatment, and follow-up visits as outlined in the study protocol.

Researchers are evaluating sacituzumab tirumotecan alone and combined with pembrolizumab compared to the treatment chosen by a physician for people with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer that cannot be removed by surgery or has spread to other parts of the body. This study focuses on participants whose cancer has progressed despite prior endocrine therapy, including treatment with a CDK4/6 inhibitor. The main goal is to see if these treatments improve progression-free survival, which means the length of time the cancer does not worsen, over up to approximately 38 months. Participants receive sacituzumab tirumotecan as an intravenous infusion, either alone or combined with intravenous pembrolizumab. The comparison group receives the treatment of physician's choice, which may include intravenous paclitaxel, nab-paclitaxel, liposomal doxorubicin, or oral capecitabine. The study is open-label and randomized, meaning participants are assigned to different treatment groups openly. Treatments are administered according to the study protocols, with ongoing monitoring during the treatment period. Throughout the study, participants are monitored regularly to assess their cancer status and overall health. This includes evaluations by blinded independent central review using RECIST 1.1 criteria to measure tumor progression. Researchers also assess safety, organ function, and performance status. The total participation time may last up to around 38 months to track progression-free survival and other outcomes. Careful monitoring helps ensure participant safety and collects data on treatment effectiveness and side effects.

This research aims to evaluate the safety and effectiveness of zilovertamab vedotin (ZV) combined with standard treatments for participants with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL). It is a Phase 2/3, randomized, open-label, multisite study including participants aged 18 and older. The study tests two main hypotheses: that ZV combined with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is better than R-GemOx alone for progression-free survival; and that ZV combined with bendamustine rituximab (BR) is better than BR alone. However, enrollment in the BR and ZV + BR arms is discontinued, so no outcome analysis will be done for those groups. The study is split into two parts: Part 1 confirms the dose of ZV, and Part 2 expands to evaluate its efficacy. Participants receive intravenous infusions of ZV at various doses, along with standard drugs including rituximab, gemcitabine, oxaliplatin, and bendamustine as appropriate. Prophylactic granulocyte colony-stimulating factor (G-CSF) is given with each ZV cycle according to institutional guidelines. Treatment schedules and doses are carefully managed to assess safety and treatment effects. During the study, participants will be monitored for dose-limiting toxicities up to about 6 weeks, and adverse events for up to approximately 68 months. Researchers will also track treatment discontinuations due to adverse events. Key outcomes include overall survival and progression-free survival up to about 35 months. Participants will have regular assessments including scans, clinical evaluations, and laboratory tests to measure response and monitor safety throughout their participation.

Researchers are investigating better treatments for people with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes called HER2 mutations. Advanced NSCLC refers to lung cancers that have spread or are unlikely to be controlled with current treatments. HER2 is a protein that helps cells grow, and mutations cause abnormal HER2 leading to cancer growth. This Phase 3 study aims to compare the safety and effectiveness of a new drug, sevabertinib, against standard treatment in patients with this type of lung cancer. Participants will be randomly assigned to receive either sevabertinib tablets twice daily by mouth or standard treatment consisting of cycles of intravenous infusions including drugs like pembrolizumab, cisplatin, carboplatin, and pemetrexed every 21 days. Treatments continue as long as participants benefit without severe side effects or until they or their doctors decide to stop. Participants on standard treatment whose disease worsens may switch to sevabertinib and continue until progression, intolerable side effects, or decision to stop. During the study, participants will undergo imaging scans such as CT, PET, MRI, and X-rays to monitor cancer spread. Health checks include blood and urine tests, heart monitoring with ECG, and pregnancy tests for women. Researchers will ask about participants’ well-being and record any medical problems or side effects experienced. The main outcome measured is progression-free survival over up to about two years.

Researchers are studying an experimental drug called odronextamab in combination with lenalidomide for adults with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL), which are subtypes of Non-Hodgkin's lymphoma. This Phase 3 study has two parts: Part 1 focuses on the safety and tolerability of this drug combination and determining the appropriate odronextamab dose, while Part 2 compares the effectiveness of this combination to the current standard treatment of rituximab plus lenalidomide. The study also explores side effects, drug levels in the blood, antibody development against the study drug, and impacts on quality of life and daily activities. Participants receive either odronextamab plus lenalidomide or rituximab plus lenalidomide according to the study protocol. Part 1 is not randomized, focusing on safety and dose finding, while Part 2 is randomized and controlled to assess efficacy and safety. Treatments are administered per protocol guidelines during these study phases. During the study, participants undergo regular evaluations including imaging scans to measure disease, blood tests, and monitoring for side effects up to two years. The main outcomes measured include dose-limiting toxicities within 35 days, treatment-emergent adverse events over two years, and progression-free survival over five years. Participants are also monitored for quality of life and ability to perform daily activities throughout the trial duration.

Researchers are evaluating an experimental drug called odronextamab for adults with previously untreated follicular lymphoma, a type of non-Hodgkin lymphoma. This Phase 3 study aims to assess the safety, tolerability, and effectiveness of odronextamab alone and compared to the current standard treatments, including rituximab combined with different types of chemotherapy. The study also examines side effects, drug levels in the blood, antibody responses against odronextamab, and the impact on quality of life and daily activities. The study consists of two parts: Part 1 is non-randomized and focuses on the safety and tolerability of odronextamab given alone. Part 2 is randomized and controlled, comparing odronextamab to rituximab combined with chemotherapy regimens such as CHOP, CVP, or Bendamustine-containing therapies. All treatments are administered according to the study protocol. Participants receive these treatments to evaluate how well odronextamab works versus standard care. Participants will undergo various assessments including imaging scans like CT or MRI to measure disease, blood tests to monitor bone marrow and liver function, and evaluations of side effects up to two years. Researchers will track dose-limiting toxicities within 35 days and assess complete response rates over 30 months. Safety and side effects will be monitored continuously, and quality of life will also be evaluated. The total length of participation depends on treatment and follow-up schedules defined in the protocol.

Researchers are evaluating whether using ultrasound-guided fascial plane blocks can reduce the occurrence of lung complications after major abdominal surgery in adults aged 65 and older. This prospective observational study focuses on patients undergoing elective major abdominal surgeries like colorectal, hepatobiliary, pancreatic, or gastric procedures under general anesthesia. The study aims to see if these nerve block techniques are linked to fewer postoperative pulmonary complications during the first week after surgery. Participants will be observed in two groups based on the anesthesia team's routine choices: one group receiving ultrasound-guided fascial plane blocks for pain relief after surgery, and the other group managed with standard pain control methods. The anesthesia team independently decides the pain management approach. No extra treatments or procedures will be performed solely for this research. During the study, researchers will track lung complications using established clinical criteria within seven days after surgery. They will also monitor secondary outcomes such as unexpected intensive care admissions, length of hospital stays, and mortality within 30 days. There will be no additional interventions, and participants' medical care follows usual clinical practices throughout the observation period.

Researchers are evaluating alternative regional anesthesia techniques to manage pain after arthroscopic shoulder surgery. The study compares the commonly used interscalene block, which is effective but may cause diaphragmatic dysfunction due to phrenic nerve blockade, with newer techniques such as the anterior suprascapular block and the pericapsular nerve group (PENG) block. These alternatives aim to provide effective pain relief while preserving respiratory function. In this study, patients will undergo one of three nerve blocks before surgery while lying on their backs and under ultrasound guidance: the interscalene block, the anterior suprascapular block, or the PENG block. Each technique targets different nerve areas around the shoulder to evaluate which provides the best pain control with the least impact on breathing. Participants will be closely monitored after surgery, with pain levels recorded during the first hour as the primary outcome. The study will assess the effectiveness and respiratory effects of each block to identify the optimal approach for managing postoperative pain in shoulder arthroscopy patients. The study includes adults aged 18 to 65 scheduled for elective shoulder surgery and will track safety and analgesic outcomes during the immediate postoperative period.

Forearm and hand surgeries are common procedures performed on both trauma patients and elective cases. For these surgeries, various anesthesia options exist, including general anesthesia, regional intravenous anesthesia, peripheral nerve blocks, and local anesthesia. Researchers are evaluating the conventional and retroclavicular approaches to the infraclavicular brachial plexus block, a regional nerve block method used to provide anesthesia and pain relief during and after forearm and hand surgeries. In this study, patients undergoing forearm and hand surgery will receive either the conventional or the retroclavicular approach to the infraclavicular block. Both approaches involve the use of 20 ml of 0.5% bupivacaine combined with 5 ml of 2% lidocaine, administered under ultrasound guidance. These procedures aim to provide effective regional anesthesia without general anesthesia. Participants will be monitored during regional anesthesia to measure the block performance time. The study focuses on the anesthesia method's effectiveness and patient outcomes during surgery. Eligible patients are adults aged 18 to 80 with a body mass index over 30, who are suitable for regional anesthesia during their forearm or hand surgery. The study excludes patients unable to perceive pain, those preferring general anesthesia, or those with contraindications to regional anesthesia.