Tunis

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 pharmacokinetics, efficacy, safety, and immune response of MB12, a proposed pembrolizumab biosimilar, compared to Keytruda® in patients with advanced stage IV non-squamous non-small cell lung cancer (NSCLC). This Phase 3, randomized, double-blind study involves patients who have not received prior systemic treatment for metastatic NSCLC and includes a range of international centers. The trial focuses on patients without EGFR activating mutations or ALK translocations and measures outcomes up to 24 weeks. Participants receive either MB12, EU-sourced Keytruda®, or US-sourced Keytruda®, each given as a 200 mg intravenous infusion every 3 weeks on Day 1. These immunotherapy drugs are combined with chemotherapy agents pemetrexed (500 mg/m2 IV every 3 weeks on Day 1) and either carboplatin (area under the curve 5 IV every 3 weeks on Day 1 for 4 cycles) or cisplatin (75 mg/m2 IV every 3 weeks on Day 1 for 4 cycles). The combination treatment is administered as a first-line therapy for metastatic NSCLC. During the study, patients are monitored for drug levels in the blood, treatment effectiveness, safety, and immune response. Regular assessments include imaging to measure tumor lesions using RECIST 1.1 criteria and evaluations of overall health and organ functions. The study aims to confirm that MB12 is similar to Keytruda® in how it is processed by the body and in its treatment results. Participants are followed for at least 24 weeks to collect data on these outcomes.

A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following participants: * Participants receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the parent trial and, in the opinion of the investigator, may derive clinical benefit from continuing treatment with luspatercept * Participants in the follow-up phase previously treated with luspatercept or placebo in the parent protocol will continue into long-term post-treatment follow-up in the rollover study until the follow-up commitments are met * The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Participants will enter transition phase and depending on their background will enter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase * Transition Phase is defined as one Enrollment visit * Treatment Phase: For participants in luspatercept treatment the dose and schedule of luspatercept in this study will be the same as the last dose and schedule in the parent luspatercept study. This does not apply to participants that are in long-term follow-up from the parent protocol * Follow-up Phase includes: \- 42 Day Safety Follow-up Visit * During the Safety Follow up, the participants will be followed for 42 days after the last dose of luspatercept, for the assessment of safety-related parameters and adverse event (AE) reporting \- Long-term Post-treatment Follow-up (LTPTFU) Phase * Participants will be followed for overall survival every 6 months for at least 5 years from first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later, or until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. Participants will also be monitored for progression to AML or any malignancies/pre-malignancies. New anticancer or disease related therapies should be collected at the same time schedule Participants transitioning from a parent luspatercept study in post-treatment follow-up (safety or LTPTFU) will continue from the same equivalent point in this rollover study. The ACE-536-LTFU-001 rollover study will be terminated, and relevant participants will discontinue from the study when all participants fulfill 5 years on the study, including treatment and follow-up.

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.

This research aims to evaluate how effective ondansetron is in preventing post-dural puncture headache, a common complication after spinal anesthesia used in cesarean sections. The study focuses on women aged 18 to 45 years, who are at 37 to 41 weeks of pregnancy, classified as ASA 2, and scheduled for elective cesarean delivery without urgent maternal or fetal emergencies. The study is a prospective, bicentric, randomized, double-blind controlled trial conducted over seven months from November 2023 to June 2024. Participants are randomly assigned to one of two groups. One group receives an intravenous dose of ondansetron (0.10 mg/kg) diluted in 5 ml of normal saline five minutes before spinal anesthesia. The other group receives an intravenous dose of 5 ml normal saline as a control, also given five minutes before spinal anesthesia. This setup allows comparison between the effects of ondansetron and placebo on the prevention of post-dural puncture headache. During the study, participants are monitored for the incidence of post-dural puncture headache over the first seven days after surgery. Researchers evaluate the occurrence of headaches and any related symptoms during this period to assess the treatment's efficacy. The study includes safety monitoring, and participants who require more than two attempts for spinal anesthesia, conversion to general anesthesia, or experience complications may be excluded. Participants who withdraw consent are also excluded, ensuring ethical standards and accurate safety data collection.

Shoulder tendinopathy is a common condition that causes pain and limits daily activities due to damage or overuse of the rotator cuff tendons. This clinical trial evaluates and compares two types of injections to treat simple shoulder tendinopathy: corticosteroid injections, which provide quick pain relief by reducing inflammation but may have short-term effects, and platelet-rich plasma (PRP) injections, made from the patient’s own blood, which may support long-term healing. The study is conducted at the Rheumatology Department of Charles Nicolle Hospital in Tunis, Tunisia, including 60 adult patients randomly assigned to one of the two treatments. Participants will receive a single injection either of corticosteroids or PRP directly into the affected shoulder tendon under sterile conditions by a trained physician. Corticosteroid injections aim to reduce inflammation and pain rapidly, while PRP injections use concentrated platelets containing growth factors to promote tissue healing and tendon recovery over time. The study monitors patients at baseline before injection, then again at one week and three months after treatment. During the study, researchers will assess pain levels using a visual analog scale (VAS) and evaluate shoulder function with two questionnaires: the Disabilities of the Arm, Shoulder and Hand (DASH) score and the Shoulder Pain and Disability Index (SPADI). These assessments occur at baseline, one week, and three months to measure changes in pain and function. The trial aims to determine which injection provides better pain relief and shoulder function improvement over time.

Researchers are evaluating the safety and clinical performance of the biodegradable polymer-coated Supraflex Cruz Sirolimus-eluting Stent (SES) in patients with multivessel coronary artery disease. This study includes an unselected, all-comer population reflecting daily clinical practice, involving patients who require coronary revascularization with drug-eluting stents. It covers patients with chronic coronary artery disease as well as those with acute coronary syndromes such as STEMI and NSTEMI. The study is a prospective, observational, single-arm, multi-center registry where all patients receive the Supraflex Cruz SES. The device is a cobalt-chromium stent coated with a biodegradable polymer that releases sirolimus. Patients with two or more affected vessels are treated exclusively with this stent. Follow-up is conducted via routine clinical practice and includes telephonic or clinical visits at 30 days, 6 months, and 12 months after the initial procedure. Participants will be monitored for safety and clinical outcomes, with the primary outcome measure being Target Lesion Failure (TLF) at 12 months. The study also allows for subgroup analyses based on clinical presentation, lesion type, and use of atherectomy. The total participation involves follow-up visits and data collection over a one-year period to assess the device's performance in real-world settings.

Severe sepsis is a serious condition marked by widespread inflammation from a severe infection, leading to improper body responses and problems in blood flow and organ function. Researchers are studying early use of norepinephrine (NE) to help increase blood pressure and support heart function faster than traditional methods. Recent studies suggest starting NE sooner may improve survival and reduce the need for large fluid amounts, which can cause complications. This study compares early norepinephrine treatment to placebo in adults with sepsis who have low blood pressure (mean arterial pressure below 65 mmHg). Norepinephrine is given in a controlled dose through an intravenous line, adjusted to body weight, while the placebo group receives a similar glucose solution. Both treatments are infused continuously through a vein at rates between 8 to 15 ml per hour. Participants will be monitored closely to assess how quickly their blood pressure stabilizes within 6 hours. The study involves observing vital signs and organ function, aiming to control shock early. Researchers will also watch for safety and treatment effects over time. The trial is conducted in multiple centers and includes adults aged 18 or older who meet sepsis criteria and have low blood pressure.

This registry study collects information on the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System used in regular clinical practice across diverse real-world populations. It serves as a Post-Market Clinical Follow-up (PMCF) to monitor the device's use after it has been released to the market. The study is observational and prospective, involving multiple centers internationally to gather data on patient outcomes. The study will involve up to 10,000 patients treated with the BioFreedom Ultra stent, which combines a cobalt chromium stent platform with a polymer and carrier-free coating of the active ingredient BA9. Patients will be enrolled from as many as 150 interventional cardiology centers in up to 15 countries, including Europe, South America, the Middle East, and Asia, over a period of 5 years. Participants will be followed for 12 months after their percutaneous coronary intervention (PCI) procedure, primarily through telephone or clinic visits, to collect data. The main outcome measured is Target Lesion Failure (TLF) at 12 months. This follow-up helps assess the real-world performance and safety of the BioFreedom Ultra stent in everyday clinical use.

Researchers are evaluating the effects of different interval training programs on physical fitness, heart and metabolic health, blood markers, and psychological well-being in young overweight or obese girls aged 12 to 15 years. The study compares moderate-intensity interval training (MIIT) alone with a combination of MIIT and high-intensity interval training (HIIT) over 12 weeks. The goal is to understand how these exercise methods impact body weight, blood lipids, and enjoyment levels in this population. Participants are divided into three groups: one group completes 12 weeks of supervised moderate-intensity interval training involving repeated 30-second work periods at 70-75% of maximal aerobic speed (MAS) with active recovery; another group does 6 weeks of MIIT followed by 6 weeks of high-intensity interval training with work periods at 100% MAS; and a control group maintains their usual physical activity without additional exercise. Each exercise group attends three supervised sessions per week and receives no special nutritional counseling. During the study, researchers monitor changes in body mass index (BMI), blood triglyceride levels, and participants' enjoyment of the training at 6 and 12 weeks. The study includes assessments of physical fitness, metabolic and blood parameters, and psychological measures. Participants are supervised throughout the 12-week period, and no dietary changes are advised beyond their usual habits.