Nabeul

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating the efficacy and safety of inavolisib combined with Phesgo compared to placebo with Phesgo as maintenance therapy in participants who have previously untreated HER2-positive advanced breast cancer with PIK3CA mutations. This Phase III, multicenter, randomized, double-blind, placebo-controlled study focuses on participants with locally advanced or metastatic breast cancer, aiming to understand the treatment impact after initial induction therapy. Participants will receive inavolisib orally once daily on Days 1 to 21 of each 21-day cycle, starting on Day 1 of Cycle 1 during maintenance treatment. Phesgo will be administered subcutaneously every three weeks on Day 1 of each cycle. The study includes an induction therapy phase where taxane-based chemotherapy is given after Phesgo. Optional endocrine therapy such as tamoxifen, aromatase inhibitors, or fulvestrant may be used based on the investigator's choice, with luteinizing hormone-releasing hormone agonists administered according to local guidelines. During the study, participants will be monitored for progression-free survival for up to approximately 40 months. Assessments include evaluation of heart function, organ function, and overall health status. Researchers will track the safety and effectiveness of the treatment combination through regular clinical evaluations and laboratory tests. The total duration includes maintenance treatment cycles and follow-up to measure outcomes and monitor safety.

Researchers are evaluating the effects of intravenous Lidocaine versus intravenous Ketamine on Interleukin-6 (IL-6) levels in patients undergoing open colorectal surgery for cancer. This randomized controlled trial includes patients with colorectal cancer who are scheduled for tumor resection. The study aims to compare how these two drugs influence inflammation, as measured by IL-6, a key inflammatory marker. Participants are adults aged 18 to 90 with acceptable physical health status for surgery. Participants are randomly assigned to one of two groups. The Lidocaine group receives a loading dose of 1.5 mg/kg followed by a continuous infusion of 1.5 mg/kg per hour over 24 hours. The Ketamine group receives a loading dose of 0.15 mg/kg followed by a continuous infusion of 0.15 mg/kg per hour over 24 hours. Both treatments are given intravenously during and after the surgery. Before surgery, IL-6 levels are measured to establish a baseline, and then again 24 hours after surgery to assess changes. These measurements help compare inflammation responses between the two groups. The study also monitors for any severe complications during surgery and tracks surgery duration. Participants are evaluated for eligibility based on health status and history of certain treatments or conditions that could affect outcomes.

This research aims to find out if taking 800 mg of oral ginger two hours before surgery can lower the chances and severity of nausea and vomiting after laparoscopic gallbladder removal surgery. The study focuses on adults undergoing this type of surgery and evaluates the prevention of postoperative nausea and vomiting within the first 24 hours after the procedure. It is a phase 4, double-blind, randomized controlled trial studying a common complication after surgery. Participants will be randomly assigned to receive either 800 mg of ginger or a placebo capsule that looks the same, given orally two hours before their laparoscopic cholecystectomy. Both groups will be monitored to compare the effects of ginger versus placebo on postoperative nausea and vomiting. The study maintains blinding to ensure unbiased results. During the study, participants will be observed for the incidence of nausea and vomiting within two hours after surgery and throughout the first 24 hours. Researchers will track symptoms and any side effects. The study includes assessments of patient condition before surgery and requires informed consent. Participation involves a single surgical procedure and follow-up for nausea and vomiting outcomes shortly after surgery.

Researchers are comparing two methods of continuous spinal anesthesia in elderly patients over 65 years old who are undergoing surgery for hip fractures. The study aims to evaluate whether the conventional landmark-guided paramedian approach or the ultrasound-guided midline approach is safer and more effective for continuous spinal anesthesia in this population. Participants will be randomly divided into two groups. One group will receive the conventional landmark-guided paramedian continuous spinal anesthesia, where the injection site is determined by palpating anatomical landmarks. The other group will receive ultrasound-guided midline continuous spinal anesthesia, where ultrasound imaging is used to locate the best interspinous space and guide needle insertion. Both procedures involve inserting an 18-gauge Tuohy needle with a 22-gauge intrathecal catheter and administering local anesthetics and fentanyl. Throughout the study, patients will be monitored with ECG, pulse oximetry, and blood pressure measurements. A fascia-iliaca ultrasound-guided block will be performed prior to the spinal anesthesia. Researchers will record the number of needle passes needed until the catheter is fixed to the skin, as well as ultrasound imaging quality and needle insertion depth. The study includes strict aseptic techniques and alternative methods if initial attempts fail. The main outcome measured is the difference in the number of needle passes between the two groups.