Polokwane

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 the effectiveness and safety of a fixed-dose combination of fluticasone propionate (Fp) and albuterol sulfate (ABS) delivered via an integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS alone in reducing severe clinical asthma exacerbations in patients with asthma. The study also assesses the efficacy of a low dose of Fp/ABS versus ABS and examines the impact on systemic corticosteroid exposure. This is a phase 3 randomized, double-blind, active-controlled trial involving patients diagnosed with asthma for at least one year. Participants will receive either a high dose or low dose of Fp/ABS or ABS alone through oral inhalation powder during a double-blind treatment period lasting a minimum of 24 weeks. The study includes a 2-week screening phase, a 2 to 4-week run-in period, and the treatment phase. Because this is an event-driven study, the total duration for individual participants may extend up to approximately 42 months depending on enrollment timing and study completion. During the study, participants will be closely monitored for time to first severe clinical asthma exacerbation while using the inhaler device. Safety and tolerability will be evaluated throughout the study. Researchers will also track systemic corticosteroid use and overall asthma control. The minimum participation time is 28 weeks, including screening and run-in, with extended monitoring possible based on study events and criteria.

Researchers are evaluating the safety and effectiveness of Volrustomig (MEDI5752) combined with Carboplatin and Pemetrexed compared to either platinum plus Pemetrexed or Nivolumab plus Ipilimumab in adults with unresectable pleural mesothelioma. This is a phase III, randomized, open-label, global study involving participants with histologically confirmed advanced pleural mesothelioma that cannot be removed by surgery. Participants will be randomly assigned to one of two groups: one group receives Volrustomig (MEDI5752), Carboplatin, and Pemetrexed administered by intravenous infusion, while the other group receives the investigator's choice of platinum plus Pemetrexed or Nivolumab plus Ipilimumab, also given intravenously. Treatment is based on the patient's tumor histology and continues according to the study protocol. During the study, participants will be monitored regularly for overall survival up to approximately 61 months. Researchers will assess disease status using measurable disease criteria and evaluate safety through clinical and laboratory tests. The study includes ongoing follow-up to observe treatment effects and monitor participant health over time.

The Childhood Hypertension Consortium of South Africa (CHCSA) was established to build connections between healthcare providers and schools through community outreach, aiming to improve understanding of blood pressure and hypertension in children, especially those of African ancestry. Currently, South Africa lacks nationally representative blood pressure reference values for children and has no data on the true prevalence of pediatric hypertension. This study seeks to develop the first national normal blood pressure reference values and clinical guidelines for managing childhood hypertension in South Africa. Children aged 5 to under 18 years from all provinces and school quintiles in South Africa will be randomly selected to participate, ensuring a representative sample of urban, peri-urban, and rural settings. The study plans to recruit 22,464 children from diverse ethnic backgrounds, including Black African, Coloured, White, and Indian/Asian groups. Blood pressure and body measurements will be taken to create South African-specific nomograms and develop hypertension management guidelines tailored to local needs. Participants will undergo blood pressure and anthropometric assessments during the study, which will collect data over five years. Researchers will measure blood pressure and body size to establish normative reference values and generate clinical practice guidelines. This information will help healthcare providers better identify and manage hypertension in South African children, with results expected to differ from current international standards. The study also includes community engagement to raise awareness and improve care for high blood pressure and related conditions.