Altindag

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.

Researchers are evaluating the pain control effectiveness of the transversalis fascia plane block in patients undergoing renal transplantation surgery. Renal transplantation involves significant postoperative pain due to lower abdominal incisions and deep tissue work. Effective pain relief is important to support early movement, reduce opioid use, and minimize side effects, potentially improving recovery and patient comfort. Participants will be divided into two groups. One group will receive an ultrasound-guided transversalis fascia plane block on the surgical side, involving an injection of 30 ml of 0.25% bupivacaine. Both groups will receive standard intraoperative pain medications, including intravenous tramadol before incision and at the end of surgery, plus intravenous paracetamol at the end of surgery. The other group will not receive the nerve block. During the study, participants will be monitored for pain levels on the day of surgery. Researchers will assess the effectiveness of pain control and opioid consumption between the groups. The study includes adults aged 18 to 65 with specific health criteria. Safety and comfort will be closely followed to understand the benefits of adding the nerve block for postoperative pain management.

Liver transplantation is a crucial treatment for patients with end-stage liver disease, and managing pain after donation surgery is important for recovery and overall health. Poor pain control after donor liver removal can lower quality of life, delay movement, and may lead to long-term pain problems. This research compares two regional anesthesia methods, intrathecal morphine and bi-level erector spinae plane block, to see which provides better pain relief after surgery in living liver donors. Participants will receive either an injection of intrathecal morphine at the lower spine or a bi-level erector spinae plane block using bupivacaine with ultrasound guidance. Both groups will also get dexketoprofen intravenously twice daily after surgery as part of a combined pain management approach. These procedures aim to reduce the need for opioids and their side effects while improving pain control. During the study, pain scores will be recorded on the day of the operation to assess effectiveness. Researchers will monitor participants' recovery, pain levels, and any side effects closely. The study includes adults aged 18 to 65 years with certain health criteria, and the overall goal is to find the best method to manage pain after liver donation surgery, supporting better outcomes for donors.

Inguinal hernia is a common surgical condition in children, and the minimally invasive percutaneous internal ring suturing (PIRS) technique is often used to treat it. This research aims to compare the pain relief effects after surgery using two different nerve block methods: rectus sheath block and caudal epidural block in children undergoing PIRS. Effective pain control with nerve blocks can reduce the need for opioids after surgery, lowering the risk of opioid-related side effects and complications. The study evaluates two procedures for managing postoperative pain. One involves injecting 0.5 mL/kg of 0.25% bupivacaine equally on both sides under ultrasound guidance for the rectus sheath block. The other uses a caudal epidural block where a needle is carefully inserted near the sacral hiatus to deliver 1 mL/kg of 0.25% bupivacaine after confirming correct placement. Both methods are performed during the surgery for postoperative pain management. Children aged 1 to 8 years who undergo PIRS surgery and receive one of these nerve blocks will be monitored. Researchers will assess pain scores on the day of surgery to compare the effectiveness of the two blocks. The study includes careful physical status evaluation and excludes children with higher physical risk or bleeding disorders to ensure safety and accurate results.

Anterior cervical discectomy is a surgical procedure performed to relieve pain, numbness, or weakness caused by cervical disc disease pressing on the spinal cord or nerve roots in the upper neck area. Researchers are comparing the pain-relief effectiveness of two nerve block techniques, the serratus posterior superior intercostal plane block and the erector spinae plane block, against a control group in patients after this surgery. The goal is to evaluate which method better reduces postoperative pain and opioid use, potentially lowering side effects and risks such as lung and heart complications. Patients in the study receive one of three treatments: the serratus posterior superior intercostal plane block or the erector spinae plane block, both administered with 30 ml of 0.25% bupivacaine guided by ultrasound, or no nerve block. All patients receive additional postoperative pain medications including paracetamol 1 g every 8 hours and dexketoprofen 50 mg twice daily intravenously as part of multimodal analgesia. Participants will be monitored for pain scores on the day of surgery. The study includes adults aged 18 to 80 years with specific health and body mass index criteria. Researchers will assess pain control effectiveness and opioid consumption, aiming to find safer and more effective pain management after anterior cervical discectomy.

Researchers are investigating the link between preoperative inflammatory biomarkers and postoperative delirium in children aged 2 to 12 years undergoing elective circumcision under general anesthesia. Postoperative delirium is a common complication that can occur even after short surgeries like circumcision. While this association has been studied in adults, there is limited data in pediatric patients. This study aims to identify simple blood markers that could help predict the risk of delirium in children after surgery. Before surgery, blood samples will be collected to measure inflammatory biomarkers such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), monocyte-to-lymphocyte ratio (MLR), systemic immune-inflammation index (SII), and systemic inflammation response index (SIRI). No experimental drugs or devices will be used, and all procedures will follow standard perioperative care. The main focus is to monitor the incidence of emergence delirium within the first two hours after circumcision using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Participants will be closely observed in the post-anesthesia care unit to assess delirium using the PAED scale. Researchers will analyze the relationship between the inflammatory biomarkers and the occurrence and severity of postoperative delirium. The study involves routine blood tests and standard anesthesia and surgery protocols, with careful monitoring during and after the procedure to ensure safety and collect necessary data.

Orchiopexy is a surgical procedure commonly used to treat cryptorchidism in children. This research aims to explore how preoperative inflammatory markers like neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), systemic immune-inflammation index, monocyte-to-lymphocyte ratio (MLR), and systemic inflammation response index relate to the occurrence of nausea and vomiting after surgery. The study focuses on pediatric patients undergoing orchiopexy to better understand the factors influencing postoperative nausea and vomiting (PONV). Before surgery, blood samples will be collected to measure these inflammatory biomarkers. The study does not involve any experimental drugs or devices, and all care will follow standard procedures. Researchers will analyze the biomarker levels in connection with the incidence of nausea and vomiting within the first six hours after the orchiopexy. Participants will be monitored closely after surgery for signs of nausea and vomiting. The main outcome measured is the occurrence of PONV within six hours postoperatively. The study includes children aged 1 to 8 years who are scheduled for elective orchiopexy and meet certain health criteria. Parental consent will be obtained, and no additional treatments beyond standard care will be administered during the study period.

Researchers are evaluating an experimental drug called ubamatamab in adult female patients with advanced ovarian cancer, including fallopian tube and primary peritoneal cancers. This phase 2 study aims to assess how safe, tolerable, and effective ubamatamab is alone and when combined with other anti-cancer drugs such as bevacizumab, cemiplimab, fianlimab, and pegylated liposomal doxorubicin (PLD). The study also investigates potential side effects, how the drugs behave in the blood over time, and whether the body produces antibodies against the treatments that might affect their performance or cause side effects. Participants receive ubamatamab administered according to the study protocol, either by itself or alongside the combination drugs bevacizumab, cemiplimab, fianlimab, PLD, or sarilumab. The exact dosing and administration follow the study plans to evaluate each treatment approach. These different treatment arms allow researchers to compare the effects of ubamatamab alone and with additional agents in patients with platinum-resistant ovarian cancer. During the study, participants have their cancer progression monitored using imaging criteria (RECIST 1.1) over a period of up to three years. Researchers regularly assess tumor response, side effects, drug levels in the blood, and immune reactions to the drugs. Safety and tolerability are closely followed, with detailed clinical evaluations and laboratory tests throughout the trial to understand how patients respond to the treatments over time.

Researchers are evaluating treatments for patients newly diagnosed with Peripheral T-Cell Lymphoma (PTCL). This Phase 3, randomized, open-label study is designed in two parts: the first aims to find the best doses of two drugs, Belinostat and Pralatrexate, combined with CHOP or COP chemotherapy. The second part compares the effectiveness and safety of Belinostat combined with CHOP, Pralatrexate combined with COP, and CHOP alone for up to six treatment cycles. The goal is to determine which treatment best improves progression-free survival over 4.5 years. In Part 1, patients are randomly assigned to one of five groups receiving different doses of Belinostat or Pralatrexate with CHOP or COP, or CHOP alone. Approximately 20 patients per group receive at least one treatment cycle to assess safety and select doses for Part 2. In Part 2, 143 patients per group are randomized 1:1:1 to receive Belinostat-CHOP, Pralatrexate-COP, or CHOP alone. Treatments are given in cycles every 21 days for up to six cycles. Belinostat is given as an intravenous infusion for five days, Pralatrexate as an intravenous push on days 1 and 8, and CHOP or COP chemotherapy on day 1, with prednisone given orally for five days. Participants undergo a 28-day screening period before treatment, followed by up to six cycles of therapy over 18 weeks. Tumor assessments occur every three cycles during treatment and regularly after treatment for up to five years to monitor disease status. Safety and treatment compliance are carefully tracked. Follow-up includes visits at least 30 days after the last dose and phone check-ins every six months for long-term survival monitoring. Researchers measure progression-free survival as the primary outcome over 4.5 years.