Nabeul

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are evaluating the effectiveness and safety of inavolisib combined with Phesgo compared to a placebo combined with Phesgo as maintenance treatment for participants with previously untreated HER2-positive advanced breast cancer that has a PIK3CA mutation. This Phase 3 study focuses on participants with locally advanced or metastatic breast cancer who have completed induction therapy. Participants first receive induction therapy with Phesgo plus taxane-based chemotherapy. Following this, they enter the maintenance phase where they are randomly assigned to receive either inavolisib tablets taken orally once daily for 21 days of each 21-day cycle along with Phesgo administered subcutaneously every 3 weeks, or a matching placebo tablet with Phesgo on the same schedule. Optional endocrine therapy may be given based on the investigators choice according to standard care. Throughout the study, participants undergo regular monitoring including tumor assessments, quality of life questionnaires, and safety evaluations lasting up to approximately 111 months. Key outcomes measured include progression-free survival assessed by investigators, overall survival, response rates, duration of response, and adverse event rates. Plasma concentrations of inavolisib are also measured at specific timepoints. Participants will be followed closely during and after treatment to assess these outcomes over an extended period.

Researchers are evaluating the effects of intravenous Lidocaine versus intravenous Ketamine in patients undergoing open colorectal surgery for cancer. This randomized controlled trial aims to compare how these two drugs influence inflammation by measuring Interleukin-6 IL-6 levels before anesthesia and 24 hours after surgery. The study also assesses pain, nausea, bowel function, hospital stay length, and postoperative complications to better understand treatment impacts. Participants are randomly assigned to one of two groups. The Lidocaine group receives a loading dose of 1.5 mgkg followed by a continuous infusion of 1.5 mgkg per hour for 24 hours. The Ketamine group receives a loading dose of 0.15 mgkg followed by a continuous infusion of 0.15 mgkg per hour over the same period. Both treatments are administered intravenously during and after surgery. During the study, patients will have blood samples taken to measure IL-6 levels before anesthesia and 24 hours after surgery. Pain will be evaluated using a numerical scale at 2, 12, and 24 hours postoperatively. Nausea, vomiting, bowel function, length of hospital stay, and complications will be monitored for up to 15 days after surgery. The entire participation includes treatment and follow-up assessments to observe recovery and outcomes.

Researchers are evaluating whether taking 800 mg of oral ginger two hours before laparoscopic gallbladder removal surgery laparoscopic cholecystectomy can reduce the occurrence and severity of nausea and vomiting after surgery. This study is a double-blind, randomized controlled trial sponsored by the University Tunis El Manar and focuses on patients aged 18 and older undergoing this surgery. Participants are randomly assigned to one of two groups one group receives 800 mg of ginger orally two hours before surgery, and the other group receives a placebo capsule that looks identical to the ginger capsule, also two hours before surgery. The study monitors outcomes within the first 24 hours after surgery. During the trial, researchers will assess the incidence of nausea and vomiting within 2 hours after surgery as the primary outcome. Secondary outcomes include recurrence of nausea and vomiting from 2 to 24 hours after surgery, total vomiting episodes, use of rescue anti-nausea medications, and any ginger-related side effects in the 24-hour post-surgery period. Participants will be evaluated through follow-up during this time to monitor these effects and ensure safety.

Researchers are comparing two techniques for continuous spinal anesthesia in elderly patients undergoing surgery for hip fractures. This study evaluates the traditional landmark guided paramedian approach against a newer ultrasound guided midline approach. The goal is to determine which method is safer and more effective for spinal anesthesia in this population, building on previous studies suggesting benefits of ultrasound guidance. Participants, all aged 65 and older, will be randomly assigned to one of two groups. One group will receive the conventional landmark guided paramedian continuous spinal anesthesia, where the injection site is identified by palpation. The other group will have the ultrasound guided midline continuous spinal anesthesia, where ultrasound imaging is used to identify the best injection site and needle angle. Both groups will receive a fascia-iliaca block before the spinal anesthesia and will be monitored closely during the procedure. During the study, patients will undergo baseline monitoring and receive standardized anesthesia preparations. Researchers will record the number of needle passes and attempts, the success rate on first try, the time to identify landmarks, and the duration of the spinal anesthesia procedure. Ultrasound images will be reviewed, and any complications will be documented. The primary outcome is the difference in needle passes between groups. Participation involves surgery and anesthesia care with detailed monitoring until catheter removal, with the study expected to last until August 2025.